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Sample records for adequately powered trials

  1. Are Power Analyses Reported with Adequate Detail? Evidence from the First Wave of Group Randomized Trials Funded by the Institute of Education Sciences

    ERIC Educational Resources Information Center

    Spybrook, Jessaca

    2008-01-01

    This study examines the reporting of power analyses in the group randomized trials funded by the Institute of Education Sciences from 2002 to 2006. A detailed power analysis provides critical information that allows reviewers to (a) replicate the power analysis and (b) assess whether the parameters used in the power analysis are reasonable.…

  2. An adequate design for regression analysis of yield trials.

    PubMed

    Gusmão, L

    1985-12-01

    Based on theoretical demonstrations and illustrated with a numerical example from triticale yield trials in Portugal, the Completely Randomized Design is proposed as the one suited for Regression Analysis. When trials are designed in Complete Randomized Blocks the regression of plot production on block mean instead of the regression of cultivar mean on the overall mean of the trial is proposed as the correct procedure for regression analysis. These proposed procedures, in addition to providing a better agreement with the assumptions for regression and the philosophy of the method, induce narrower confidence intervals and attenuation of the hyperbolic effect. The increase in precision is brought about by both a decrease in the t Student values by an increased number of degrees of freedom, and by a decrease in standard error by a non proportional increase of residual variance and non proportional increase of the sum of squares of the assumed independent variable. The new procedures seem to be promising for a better understanding of the mechanism of specific instability.

  3. Towards Defining Adequate Lithium Trials for Individuals with Mental Retardation and Mental Illness.

    ERIC Educational Resources Information Center

    Pary, Robert J.

    1991-01-01

    Use of lithium with mentally retarded individuals with psychiatric conditions and/or behavior disturbances is discussed. The paper describes components of an adequate clinical trial and reviews case studies and double-blind cases. The paper concludes that aggression is the best indicator for lithium use, and reviews treatment parameters and…

  4. Does the new EU Regulation on clinical trials adequately protect vulnerable research participants?

    PubMed

    Gennet, Éloïse; Andorno, Roberto; Elger, Bernice

    2015-07-01

    Vulnerable research participants deserve special protection because of their increased risks of being wronged. Yet, paradoxically, the conduct of trials involving vulnerable groups is sometimes inescapable to develop safe and efficient therapies suitable to these groups. The key question is therefore how to protect vulnerable research participants from harm and exploitation without excluding the populations they belong to from the benefits of research. The European Union faced this challenge in April 2014 when adopting the new Regulation on clinical trials, which will replace the currently applicable 2001 Clinical Trials Directive in 2016. In order to assess the protection of vulnerable persons in the new Regulation, this paper makes four suggestions: first, the need to adopt a risk-based approach to vulnerability in biomedical research; second, to better distinguish between decisional vulnerabilities and health-related vulnerabilities; third, to emphasise the need to preserve the freedom of consent of subjects with decisional vulnerability, who are more susceptible to undue influence; and finally to assert the need of actively promoting specific clinical trials involving people with physical or psychological vulnerabilities. In conclusion, this paper claims that the protection of vulnerable subjects still needs to be improved in the new EU Regulation.

  5. Covariate Adjustment Strategy Increases Power in the Randomized Controlled Trial With Discrete-Time Survival Endpoints

    ERIC Educational Resources Information Center

    Safarkhani, Maryam; Moerbeek, Mirjam

    2013-01-01

    In a randomized controlled trial, a decision needs to be made about the total number of subjects for adequate statistical power. One way to increase the power of a trial is by including a predictive covariate in the model. In this article, the effects of various covariate adjustment strategies on increasing the power is studied for discrete-time…

  6. [Adequate application of quantitative and qualitative statistic analytic methods in acupuncture clinical trials].

    PubMed

    Tan, Ming T; Liu, Jian-ping; Lao, Lixing

    2012-08-01

    Recently, proper use of the statistical methods in traditional Chinese medicine (TCM) randomized controlled trials (RCTs) has received increased attention. Statistical inference based on hypothesis testing is the foundation of clinical trials and evidence-based medicine. In this article, the authors described the methodological differences between literature published in Chinese and Western journals in the design and analysis of acupuncture RCTs and the application of basic statistical principles. In China, qualitative analysis method has been widely used in acupuncture and TCM clinical trials, while the between-group quantitative analysis methods on clinical symptom scores are commonly used in the West. The evidence for and against these analytical differences were discussed based on the data of RCTs assessing acupuncture for pain relief. The authors concluded that although both methods have their unique advantages, quantitative analysis should be used as the primary analysis while qualitative analysis can be a secondary criterion for analysis. The purpose of this paper is to inspire further discussion of such special issues in clinical research design and thus contribute to the increased scientific rigor of TCM research.

  7. Comparison of adequate relief with symptom, global, and responder endpoints in linaclotide phase 3 trials in IBS-C

    PubMed Central

    Camilleri, Michael; Lembo, Anthony J; Lavins, Bernard J; MacDougall, James E; Carson, Robyn T; Williams, Valerie SL; Nelson, Lauren M; Shiff, Steven J; Currie, Mark G; Kurtz, Caroline B

    2015-01-01

    Background Optimal clinical trial endpoints for irritable bowel syndrome with constipation (IBS-C) are uncertain. Objective The objective of this article is to compare adequate relief (AR) to abdominal/bowel symptoms, global endpoints, and FDA and EMA responder criteria; and to use AR as an anchor to assess clinically meaningful change (CMC) in IBS-C symptoms. Methods Using pooled 12-week data from two phase 3 linaclotide clinical trials, daily abdominal/bowel symptoms and weekly global assessments were correlated with AR. Symptom CMC thresholds were estimated using AR as an anchor. Agreement between AR and FDA/EMA responder criteria was assessed. Results Correlations of AR with percentage change in abdominal symptoms, bowel symptoms, and global endpoints ranged from 0.48–0.54, 0.32–0.39, and 0.61–0.71, respectively. Using AR as an anchor, CMC thresholds were 29% improvement in abdominal pain, 29% improvement in abdominal discomfort, and 0.7/week increase in CSBMs, similar to thresholds for IBS-C responder endpoints recommended by the FDA and EMA. There was considerable agreement of weekly responder rates between AR and the FDA and EMA endpoints (on average, 70%–76% and 71%–82% of weeks with agreement, respectively). Conclusions AR bridges IBS-C clinical trials, putting into perspective the disparate primary endpoints recommended by professional societies and regulatory authorities, and allowing researchers, practitioners, and regulators to compare trial results. PMID:25653859

  8. Peak power during repeated wingate trials: implications for testing.

    PubMed

    Kohler, Ryan M; Rundell, Kenneth W; Evans, Tina M; Levine, Alan M

    2010-02-01

    Maximal power production is of primary importance for many sporting events. Therefore, using a test that has been shown to be both valid and reliable will allow for accurate baseline testing, measurement of progress, and evaluation of performance. This study examined peak power (PP) during repeated Wingate trials after no warm-up (NWU), a steady state warm-up, and an interval warm-up. In a randomized placebo-controlled study, 11 subjects (38 +/- 8.2 years) performed two 10-second Wingate trials with 4 minutes of recovery between efforts. Warm-up protocols were completed before each Wingate trial and were immediately followed by trial I. Peak power was measured during each trial. Results indicate that PP is not significantly (p > 0.05) different from trial I to trial II for either of the warm-up protocols. The NWU trial II was significantly greater than the NWU trial I (855 +/- 230 W > 814 +/- 222 W, p < 0.05) when analyzed with a paired samples t-test. Peak power appears to be greatest after a general self-selected warm-up, but not after a previously intense bike warm-up. When testing for maximal power output via the Wingate anaerobic test, one should allow for a familiarization trial and should ensure full recovery between this trial and the baseline evaluation.

  9. Power Analysis of Cutoff-Based Randomized Clinical Trials.

    ERIC Educational Resources Information Center

    Cappelleri, Joseph C.; And Others

    1994-01-01

    A statistical power algorithm based on the Fisher Z method is developed for cutoff-based random clinical trials and the single cutoff-point (regression-discontinuity) design that has no randomization. This article quantifies power and sample size estimates for various levels of power and cutoff-based assignment. (Author/SLD)

  10. Adverse prognostic value of peritumoral vascular invasion: is it abrogated by adequate endocrine adjuvant therapy? Results from two International Breast Cancer Study Group randomized trials of chemoendocrine adjuvant therapy for early breast cancer

    PubMed Central

    Viale, G.; Giobbie-Hurder, A.; Gusterson, B. A.; Maiorano, E.; Mastropasqua, M. G.; Sonzogni, A.; Mallon, E.; Colleoni, M.; Castiglione-Gertsch, M.; Regan, M. M.; Brown, R. W.; Golouh, R.; Crivellari, D.; Karlsson, P.; Öhlschlegel, C.; Gelber, R. D.; Goldhirsch, A.; Coates, A. S.

    2010-01-01

    Background: Peritumoral vascular invasion (PVI) may assist in assigning optimal adjuvant systemic therapy for women with early breast cancer. Patients and methods: Patients participated in two International Breast Cancer Study Group randomized trials testing chemoendocrine adjuvant therapies in premenopausal (trial VIII) or postmenopausal (trial IX) node-negative breast cancer. PVI was assessed by institutional pathologists and/or central review on hematoxylin–eosin-stained slides in 99% of patients (analysis cohort 2754 patients, median follow-up >9 years). Results: PVI, present in 23% of the tumors, was associated with higher grade tumors and larger tumor size (trial IX only). Presence of PVI increased locoregional and distant recurrence and was significantly associated with poorer disease-free survival. The adverse prognostic impact of PVI in trial VIII was limited to premenopausal patients with endocrine-responsive tumors randomized to therapies not containing goserelin, and conversely the beneficial effect of goserelin was limited to patients whose tumors showed PVI. In trial IX, all patients received tamoxifen: the adverse prognostic impact of PVI was limited to patients with receptor-negative tumors regardless of chemotherapy. Conclusion: Adequate endocrine adjuvant therapy appears to abrogate the adverse impact of PVI in node-negative disease, while PVI may identify patients who will benefit particularly from adjuvant therapy. PMID:19633051

  11. Power calculations for clinical trials in Alzheimer's disease.

    PubMed

    Ard, M Colin; Edland, Steven D

    2011-01-01

    The Alzheimer research community is actively pursuing novel biomarker and other biologic measures to characterize disease progression or to use as outcome measures in clinical trials. One product of these efforts has been a large literature reporting power calculations and estimates of sample size for planning future clinical trials and cohort studies with longitudinal rate of change outcome measures. Sample size estimates reported in this literature vary greatly depending on a variety of factors, including the statistical methods and model assumptions used in their calculation. We review this literature and suggest standards for reporting power calculation results. Regardless of the statistical methods used, studies consistently find that volumetric neuroimaging measures of regions of interest, such as hippocampal volume, outperform global cognitive scales traditionally used in clinical treatment trials in terms of the number of subjects required to detect a fixed percentage slowing of the rate of change observed in demented and cognitively impaired populations. However, statistical methods, model assumptions, and parameter estimates used in power calculations are often not reported in sufficient detail to be of maximum utility. We review the factors that influence sample size estimates, and discuss outstanding issues relevant to planning longitudinal studies of Alzheimer's disease.

  12. Power analyses for negative binomial models with application to multiple sclerosis clinical trials.

    PubMed

    Rettiganti, Mallik; Nagaraja, H N

    2012-01-01

    We use negative binomial (NB) models for the magnetic resonance imaging (MRI)-based brain lesion count data from parallel group (PG) and baseline versus treatment (BVT) trials for relapsing remitting multiple sclerosis (RRMS) patients, and describe the associated likelihood ratio (LR), score, and Wald tests. We perform power analyses and sample size estimation using the simulated percentiles of the exact distribution of the test statistics for the PG and BVT trials. When compared to the corresponding nonparametric test, the LR test results in 30-45% reduction in sample sizes for the PG trials and 25-60% reduction for the BVT trials.

  13. Power Calculations for Binary Moderator in Cluster Randomized Trials

    ERIC Educational Resources Information Center

    Spybrook, Jessaca; Kelcey, Ben

    2014-01-01

    Cluster randomized trials (CRTs), or studies in which intact groups of individuals are randomly assigned to a condition, are becoming more common in the evaluation of educational programs, policies, and practices. The website for the National Center for Education Evaluation and Regional Assistance (NCEE) reveals they have launched over 30…

  14. Understanding Statistical Power in Cluster Randomized Trials: Challenges Posed by Differences in Notation and Terminology

    ERIC Educational Resources Information Center

    Spybrook, Jessaca; Hedges, Larry; Borenstein, Michael

    2014-01-01

    Research designs in which clusters are the unit of randomization are quite common in the social sciences. Given the multilevel nature of these studies, the power analyses for these studies are more complex than in a simple individually randomized trial. Tools are now available to help researchers conduct power analyses for cluster randomized…

  15. Estimating the power of a Mycobacterium bovis vaccine trial in Irish badgers.

    PubMed

    Aznar, I; More, S J; Frankena, K; De Jong, M C M

    2013-09-01

    The aim of this study was to estimate the power, using simulation techniques, of a group randomized vaccine field trial designed to assess the effect of vaccination on Mycobacterium bovis transmission in badgers. The effects of sample size (recapture percentage), initial prevalence, sensitivity and specificity of the diagnostic test, transmission rate between unvaccinated badgers, Vaccine Efficacy for Susceptibility (VES) and Vaccine Efficacy for Infectiousness (VEI), on study power were determined. Sample size had a small effect on power. Study power increased with increasing transmission rate between non-vaccinated badgers. Changes in VES had a higher impact on power than changes in VEI. However, the largest effect on study power was associated with changes in the specificity of the diagnostic test, within the range of input values that were used for all other modelled parameters. Specificity values below 99.4% yielded a study power below 50% even when sensitivity was 100% and, VEI and VES were both equal to 80%. The effect of changes in sensitivity on study power was much lower. The results from our study are in line with previous studies, as study power was dependent not only on sample size but on many other variables. In this study, additional variables were studied, i.e. test sensitivity and specificity. In the current vaccine trial, power was highly dependent on the specificity of the diagnostic test. Therefore, it is critical that the diagnostic test used in the badger vaccine trial is optimized to maximize test specificity.

  16. The sea trial of the wave power generator 'Kaimei'

    NASA Astrophysics Data System (ADS)

    Masuda, Y.; Miyazaki, T.

    1980-10-01

    An experimental Japanese prototype of a wave-power electricity generator system is examined. Construction details and experimental data are presented. The ship-type floating structure, 80 meters in length and 500 tons dead weight, used a non-valve Wells turbine of 0.6 m diameter with four wings, whose energy conversion efficiency was found to be greater than 60% with very small waves, and whose safety factor was found to be greater than that of the impulse turbine. The 'Kaimei' is concluded to be promising, but some technical problems, including increasing and smoothing the output power, remain to be solved.

  17. The Power of Malaria Vaccine Trials Using Controlled Human Malaria Infection

    PubMed Central

    Hermsen, Cornelus C.; Sauerwein, Robert W.; de Vlas, Sake J.

    2017-01-01

    Controlled human malaria infection (CHMI) in healthy human volunteers is an important and powerful tool in clinical malaria vaccine development. However, power calculations are essential to obtain meaningful estimates of protective efficacy, while minimizing the risk of adverse events. To optimize power calculations for CHMI-based malaria vaccine trials, we developed a novel non-linear statistical model for parasite kinetics as measured by qPCR, using data from mosquito-based CHMI experiments in 57 individuals. We robustly account for important sources of variation between and within individuals using a Bayesian framework. Study power is most dependent on the number of individuals in each treatment arm; inter-individual variation in vaccine efficacy and the number of blood samples taken per day matter relatively little. Due to high inter-individual variation in the number of first-generation parasites, hepatic vaccine trials required significantly more study subjects than erythrocytic vaccine trials. We provide power calculations for hypothetical malaria vaccine trials of various designs and conclude that so far, power calculations have been overly optimistic. We further illustrate how upcoming techniques like needle-injected CHMI may reduce required sample sizes. PMID:28081133

  18. Power considerations for trials of two experimental arms versus a standard active control or placebo.

    PubMed

    Hasselblad, Vic

    2016-10-01

    The power of the two-experimental arm trial depends on three choices: (1) when one arm is dropped (if at all); (2) the final testing procedure, assuming no dropping; and (3) the sampling ratio for the three arms. Multiple-arm designs require critical values which were calculated using Mathematica. Power calculations were exact based on probabilities from binomial distributions. The "drop the loser" strategy is optimal for the primary endpoint. The equal sized two treated arm trial gives reasonable power for the primary as well as good power to select the best treated arm. The best power was provided by the 3:3:4 sampling, but it was only marginally better.

  19. Effects of power variation on cycle performance during simulated hilly time-trials.

    PubMed

    Wells, Marc S; Marwood, Simon

    2016-11-01

    It has previously been shown that cyclists are unable to maintain a constant power output during cycle time-trials on hilly courses. The purpose of the present study is therefore to quantify these effects of power variation using a mathematical model of cycling performance. A hypothetical cyclist (body mass: 70 kg, bicycle mass: 10 kg) was studied using a mathematical model of cycling, which included the effects of acceleration. Performance was modelled over three hypothetical 40-km courses, comprising repeated 2.5-km sections of uphill and downhill with gradients of 1%, 3%, and 6%, respectively. Amplitude (5-15%) and distance (0.31-20.00 km) of variation were modelled over a range of mean power outputs (200-600 W) and compared to sustaining a constant power. Power variation was typically detrimental to performance; these effects were augmented as the amplitude of variation and severity of gradient increased. Varying power every 1.25 km was most detrimental to performance; at a mean power of 200 W, performance was impaired by 43.90 s (±15% variation, 6% gradient). However at the steepest gradients, the effect of power variation was relatively independent of the distance of variation. In contrast, varying power in parallel with changes in gradient improved performance by 188.89 s (±15% variation, 6% gradient) at 200 W. The present data demonstrate that during hilly time-trials, power variation that does not occur in parallel with changes in gradient is detrimental to performance, especially at steeper gradients. These adverse effects are substantially larger than those previously observed during flat, windless time-trials.

  20. Subsets of a Large Cognitive Battery Better Power Clinical Trials on Early Stage Alzheimer Disease

    PubMed Central

    Xiong, Chengjie; Weng, Hua; Bennett, David A.; Boyle, Patricia A.; Shah, Raj C.; Fague, Scot; Hall, Charles B.; Lipton, Richard B.; Morris, John C.

    2014-01-01

    Background/Aims Cognitive batteries routinely used by the Alzheimer disease (AD) research community may contain items uninformative for tracking disease progression to power clinical trials on early stage AD. We aim to identify subsets of the most informative items from an existing cognitive battery for better powering clinical trials on early AD. Methods Longitudinal change in item scores from the battery was associated with the onset of Mild Cognitive Impairment (MCI) in 1513 elderly individuals. Items whose longitudinal changes were correlated with the onset of MCI were selected as informative for tracking the early cognitive progression. Results 226 items in the battery were annually assessed over a follow-up of up to 13 years. Changes of item scores over time from 187 items were significantly correlated with the onset of MCI. For clinical trials on preclinical AD and on MCI, informative items permit smaller or similar sample sizes as compared to the entire battery, whereas uninformative items require much larger sample sizes. Conclusions Longitudinal changes in item scores from about 17% of items in the cognitive battery are uninformative for tracking early disease progression. Clinical trials on early AD can be better powered using informative items rather than the entire battery. PMID:25376544

  1. Calculating Power by Bootstrap, with an Application to Cluster-Randomized Trials

    PubMed Central

    Kleinman, Ken; Huang, Susan S.

    2016-01-01

    Background: A key requirement for a useful power calculation is that the calculation mimic the data analysis that will be performed on the actual data, once that data is observed. Close approximations may be difficult to achieve using analytic solutions, however, and thus Monte Carlo approaches, including both simulation and bootstrap resampling, are often attractive. One setting in which this is particularly true is cluster-randomized trial designs. However, Monte Carlo approaches are useful in many additional settings as well. Calculating power for cluster-randomized trials using analytic or simulation-based methods is frequently unsatisfactory due to the complexity of the data analysis methods to be employed and to the sparseness of data to inform the choice of important parameters in these methods. Methods: We propose that among Monte Carlo methods, bootstrap approaches are most likely to generate data similar to the observed data. In bootstrap approaches, real data are resampled to build complete data sets based on real data that resemble the data for the intended analyses. In contrast, simulation methods would use the real data to estimate parameters for the data, and would then simulate data using these parameters. We describe means of implementing bootstrap power calculation. Results: We demonstrate bootstrap power calculation for a cluster-randomized trial with a censored survival outcome and a baseline observation period. Conclusions: Bootstrap power calculation is a natural application of resampling methods. It provides a relatively simple solution to power calculation that is likely to be more accurate than analytic solutions or simulation-based calculations, in the sense that the bootstrap approach does not rely on the assumptions inherent in analytic calculations. This method of calculation has several important strengths. Notably, it is simple to achieve great fidelity to the proposed data analysis method and there is no requirement for parameter

  2. Optimal cycling time trial position models: aerodynamics versus power output and metabolic energy.

    PubMed

    Fintelman, D M; Sterling, M; Hemida, H; Li, F-X

    2014-06-03

    The aerodynamic drag of a cyclist in time trial (TT) position is strongly influenced by the torso angle. While decreasing the torso angle reduces the drag, it limits the physiological functioning of the cyclist. Therefore the aims of this study were to predict the optimal TT cycling position as function of the cycling speed and to determine at which speed the aerodynamic power losses start to dominate. Two models were developed to determine the optimal torso angle: a 'Metabolic Energy Model' and a 'Power Output Model'. The Metabolic Energy Model minimised the required cycling energy expenditure, while the Power Output Model maximised the cyclists׳ power output. The input parameters were experimentally collected from 19 TT cyclists at different torso angle positions (0-24°). The results showed that for both models, the optimal torso angle depends strongly on the cycling speed, with decreasing torso angles at increasing speeds. The aerodynamic losses outweigh the power losses at cycling speeds above 46km/h. However, a fully horizontal torso is not optimal. For speeds below 30km/h, it is beneficial to ride in a more upright TT position. The two model outputs were not completely similar, due to the different model approaches. The Metabolic Energy Model could be applied for endurance events, while the Power Output Model is more suitable in sprinting or in variable conditions (wind, undulating course, etc.). It is suggested that despite some limitations, the models give valuable information about improving the cycling performance by optimising the TT cycling position.

  3. Early stopping in clinical trials and epidemiologic studies for "futility": conditional power versus sequential analysis.

    PubMed

    van der Tweel, Ingeborg; van Noord, Paulus A H

    2003-07-01

    Early stopping of a clinical trial is well accepted when there is enough evidence for a significant effect. However, during the course of a trial, there can be reasons to consider early termination for "futility." In epidemiologic studies, costly or destructive laboratory tests or slow case accrual can make it desirable to stop a study early for reasons of efficiency. Estimation of the conditional power (CP) is proposed as a decision tool to stop a study early or to continue it. We consider the disadvantages of this method. We propose (group) sequential continuation of the trial or study as a less arbitrary strategy. We re-analyzed two data sets from the literature to illustrate the advantages of a sequential approach. We conclude that (group) sequential analyses have several advantages over CP. More studies should consider a sequential design and analysis to enable early stopping when enough evidence has accumulated to conclude a lack of the expected effect. Such a strategy can save valuable resources for more promising hypotheses.

  4. A General Framework for Power Analysis to Detect the Moderator Effects in Two- and Three-Level Cluster Randomized Trials

    ERIC Educational Resources Information Center

    Dong, Nianbo; Spybrook, Jessaca; Kelcey, Ben

    2016-01-01

    The purpose of this study is to propose a general framework for power analyses to detect the moderator effects in two- and three-level cluster randomized trials (CRTs). The study specifically aims to: (1) develop the statistical formulations for calculating statistical power, minimum detectable effect size (MDES) and its confidence interval to…

  5. How many patients complete an adequate trial of donepezil?

    PubMed

    Roe, Catherine M; Anderson, Michael J; Spivack, Barney

    2002-01-01

    Pharmacy claims data were used to evaluate medication adherence among 59 new users of donepezil aged 65 to 94 years. The probability (+/- 95% confidence interval) of a new user continuing donepezil at 90 days was.797 +/-.103 and at 180 days was.627 +/-.124. Additionally, 13.9% of those who continued therapy for at least 180 days showed gaps in treatment of six weeks or more. These results suggest that adherence with donepezil could be improved in clinical practice.

  6. 21 CFR 1404.900 - Adequate evidence.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Adequate evidence. 1404.900 Section 1404.900 Food and Drugs OFFICE OF NATIONAL DRUG CONTROL POLICY GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) Definitions § 1404.900 Adequate evidence. Adequate evidence means information sufficient...

  7. 21 CFR 1404.900 - Adequate evidence.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Adequate evidence. 1404.900 Section 1404.900 Food and Drugs OFFICE OF NATIONAL DRUG CONTROL POLICY GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) Definitions § 1404.900 Adequate evidence. Adequate evidence means information sufficient...

  8. Effectiveness of a Wheelchair Skills Training Program for Powered Wheelchair Users: A Randomized Controlled Trial

    PubMed Central

    Kirby, R. Lee; Miller, William C.; Routhier, Francois; Demers, Louise; Mihailidis, Alex; Polgar, Jan Miller; Rushton, Paula W.; Titus, Laura; Smith, Cher; McAllister, Mike; Theriault, Chris; Thompson, Kara; Sawatzky, Bonita

    2015-01-01

    Objectives To test the hypothesis that powered wheelchair users who receive the Wheelchair Skills Training Program (WSTP) improve their wheelchair skills in comparison with a Control group that receives standard care. Our secondary objectives were to assess goal achievement, satisfaction with training, retention, injury rate, confidence with wheelchair use and participation. Design Randomized controlled trial (RCT). Setting Rehabilitation centers and communities. Participants 116 powered wheelchair users. Intervention Five 30-minute WSTP training sessions. Main Outcome Measures Assessments were done at baseline (T1), post-training (T2) and 3 months post-training (T3) using the Wheelchair Skills Test Questionnaire (WST-Q 4.1), Goal Attainment Score (GAS), Satisfaction Questionnaire, Injury Rate, Wheelchair Use Confidence Scale for Power Wheelchair Users (WheelCon) and Life Space Assessment (LSA). Results There was no significant T2-T1 difference between the groups for WST-Q capacity scores (p = 0.600) but the difference for WST-Q performance scores was significant (p = 0.016) with a relative (T2/T1 x 100%) improvement of the median score for the Intervention group of 10.8%. The mean (SD) GAS for the Intervention group after training was 92.8% (11.4) and satisfaction with training was high. The WST-Q gain was not retained at T3. There was no clinically significant difference between the groups in injury rate and no statistically significant differences in WheelCon or LSA scores at T3. Conclusions Powered wheelchair users who receive formal wheelchair skills training demonstrate modest transient post-training improvements in their WST-Q performance scores, they have substantial improvements on individualized goals and they are positive about training. PMID:26232684

  9. The Trial Software version for DEMETER power spectrum files visualization and mapping

    NASA Astrophysics Data System (ADS)

    Lozbin, Anatoliy; Inchin, Alexander; Shpadi, Maxim

    2010-05-01

    In the frame of Kazakhstan's Scientific Space System creation for earthquakes precursors research, the hardware and software of DEMETER satellite was investigated. The data processing Software of DEMETER is based on package SWAN under IDL Virtual machine and realizes many features, but we can't find an important tool for the spectrograms analysis - space-time visualization of power spectrum files from electromagnetic devices as ICE and IMSC. For elimination of this problem we have developed Software which is offered to use. The DeSS (DEMETER Spectrogram Software) - it is Software for visualization, analysis and a mapping of power spectrum data from electromagnetic devices ICE and IMSC. The Software primary goal is to give the researcher friendly tool for the analysis of electromagnetic data from DEMETER Satellite for earthquake precursors and other ionosphere events researches. The Input data for DeSS Software is a power spectrum files: - Power spectrum of 1 component of the electric field in the VLF range (APID 1132); - Power spectrum of 1 component of the electric field in the HF range (APID 1134); - Power spectrum of 1 component of the magnetic field in the VLF range (APID 1137). The main features and operations of the software is possible: - various time and frequency filtration; - visualization of time dependence of signal intensity on fixed frequency; - spectral density visualization for fixed frequency range; - spectrogram autosize and smooth spectrogram; - the information in each point of the spectrogram: time, frequency and intensity; - the spectrum information in the separate window, consisting of 4 blocks; - data mapping with 6 range scale. On the map we can browse next information: - satellite orbit; - conjugate point at the satellite altitude; - north conjugate point at the altitude 110 km; - south conjugate point at the altitude 110 km. This is only trial software version to help the researchers and we always ready collaborate with scientists for

  10. Trial-by-trial coupling between EEG and BOLD identifies networks related to alpha and theta EEG power increases during working memory maintenance.

    PubMed

    Scheeringa, René; Petersson, Karl Magnus; Oostenveld, Robert; Norris, David G; Hagoort, Peter; Bastiaansen, Marcel C M

    2009-02-01

    PET and fMRI experiments have previously shown that several brain regions in the frontal and parietal lobe are involved in working memory maintenance. MEG and EEG experiments have shown parametric increases with load for oscillatory activity in posterior alpha and frontal theta power. In the current study we investigated whether the areas found with fMRI can be associated with these alpha and theta effects by measuring simultaneous EEG and fMRI during a modified Sternberg task This allowed us to correlate EEG at the single trial level with the fMRI BOLD signal by forming a regressor based on single trial alpha and theta power estimates. We observed a right posterior, parametric alpha power increase, which was functionally related to decreases in BOLD in the primary visual cortex and in the posterior part of the right middle temporal gyrus. We relate this finding to the inhibition of neuronal activity that may interfere with WM maintenance. An observed parametric increase in frontal theta power was correlated to a decrease in BOLD in regions that together form the default mode network. We did not observe correlations between oscillatory EEG phenomena and BOLD in the traditional WM areas. In conclusion, the study shows that simultaneous EEG-fMRI recordings can be successfully used to identify the emergence of functional networks in the brain during the execution of a cognitive task.

  11. 5 CFR 919.900 - Adequate evidence.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Adequate evidence. 919.900 Section 919.900 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS (CONTINUED) GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) Definitions § 919.900 Adequate...

  12. Power Calculations for Moderators in Multi-Site Cluster Randomized Trials

    ERIC Educational Resources Information Center

    Spybrook, Jessaca; Kelcey, Ben; Dong, Nianbo

    2016-01-01

    Cluster randomized trials (CRTs), or studies in which intact groups of individuals are randomly assigned to a condition, are becoming more common in evaluation studies of educational programs. A specific type of CRT in which clusters are randomly assigned to treatment within blocks or sites, known as multisite cluster randomized trials (MSCRTs),…

  13. A powerful and robust test statistic for randomization inference in group-randomized trials with matched pairs of groups.

    PubMed

    Zhang, Kai; Traskin, Mikhail; Small, Dylan S

    2012-03-01

    For group-randomized trials, randomization inference based on rank statistics provides robust, exact inference against nonnormal distributions. However, in a matched-pair design, the currently available rank-based statistics lose significant power compared to normal linear mixed model (LMM) test statistics when the LMM is true. In this article, we investigate and develop an optimal test statistic over all statistics in the form of the weighted sum of signed Mann-Whitney-Wilcoxon statistics under certain assumptions. This test is almost as powerful as the LMM even when the LMM is true, but it is much more powerful for heavy tailed distributions. A simulation study is conducted to examine the power.

  14. Genetic modification of preimplantation embryos: toward adequate human research policies.

    PubMed

    Dresser, Rebecca

    2004-01-01

    Citing advances in transgenic animal research and setbacks in human trials of somatic cell genetic interventions, some scientists and others want to begin planning for research involving the genetic modification of human embryos. Because this form of genetic modification could affect later-born children and their offspring, the protection of human subjects should be a priority in decisions about whether to proceed with such research. Yet because of gaps in existing federal policies, embryo modification proposals might not receive adequate scientific and ethical scrutiny. This article describes current policy shortcomings and recommends policy actions designed to ensure that the investigational genetic modification of embryos meets accepted standards for research on human subjects.

  15. Asbestos/NESHAP adequately wet guidance

    SciTech Connect

    Shafer, R.; Throwe, S.; Salgado, O.; Garlow, C.; Hoerath, E.

    1990-12-01

    The Asbestos NESHAP requires facility owners and/or operators involved in demolition and renovation activities to control emissions of particulate asbestos to the outside air because no safe concentration of airborne asbestos has ever been established. The primary method used to control asbestos emissions is to adequately wet the Asbestos Containing Material (ACM) with a wetting agent prior to, during and after demolition/renovation activities. The purpose of the document is to provide guidance to asbestos inspectors and the regulated community on how to determine if friable ACM is adequately wet as required by the Asbestos NESHAP.

  16. Funding the Formula Adequately in Oklahoma

    ERIC Educational Resources Information Center

    Hancock, Kenneth

    2015-01-01

    This report is a longevity, simulational study that looks at how the ratio of state support to local support effects the number of school districts that breaks the common school's funding formula which in turns effects the equity of distribution to the common schools. After nearly two decades of adequately supporting the funding formula, Oklahoma…

  17. CORE-Hom: a powerful and exhaustive database of clinical trials in homeopathy.

    PubMed

    Clausen, Jürgen; Moss, Sian; Tournier, Alexander; Lüdtke, Rainer; Albrecht, Henning

    2014-10-01

    The CORE-Hom database was created to answer the need for a reliable and publicly available source of information in the field of clinical research in homeopathy. As of May 2014 it held 1048 entries of clinical trials, observational studies and surveys in the field of homeopathy, including second publications and re-analyses. 352 of the trials referenced in the database were published in peer reviewed journals, 198 of which were randomised controlled trials. The most often used remedies were Arnica montana (n = 103) and Traumeel(®) (n = 40). The most studied medical conditions were respiratory tract infections (n = 126) and traumatic injuries (n = 110). The aim of this article is to introduce the database to the public, describing and explaining the interface, features and content of the CORE-Hom database.

  18. Power Calculations and Placebo Effect for Future Clinical Trials in Progressive Supranuclear Palsy

    PubMed Central

    Stamelou, Maria; Schöpe, Jakob; Wagenpfeil, Stefan; Ser, Teodoro Del; Bang, Jee; Lobach, Iryna Y.; Luong, Phi; Respondek, Gesine; Oertel, Wolfgang H.; Boxer, Adam L.; Höglinger, Günter U.

    2016-01-01

    Background Two recent randomized, placebo-controlled trials of putative disease-modifying agents (davunetide, tideglusib) in progressive supranuclear palsy (PSP) failed to show efficacy, but generated data relevant for future trials. Methods We provide sample size calculations based on data collected in 187 PSP patients assigned to placebo in these trials. A placebo effect was calculated. Results The total PSP-Rating Scale required the least number of patients per group (N = 51) to detect a 50% change in the 1-year progression and 39 when including patients with ≤ 5 years disease duration. The Schwab and England Activities of Daily Living required 70 patients per group and was highly correlated with the PSP-Rating Scale. A placebo effect was not detected in these scales. Conclusions We propose the 1-year PSP-Rating Scale score change as the single primary readout in clinical neuroprotective or disease-modifying trials. The Schwab and England Activities of Daily Living could be used as a secondary outcome. PMID:26948290

  19. Power in Play: A Foucauldian Reading of A.O. Soyinka's "The Trials of Brother Jero"

    ERIC Educational Resources Information Center

    Davoodifar, Mahboobeh; Asl, Moussa Pourya

    2015-01-01

    This work utilizes Foucault's articulations on the power strategies of our contemporary society. To him the subject's constitution is never a purely passive effect of power on the subject but requires the subject's own activity. This necessitates the existence of a dynamic, mutually affecting relationship, implying that one can be both dominated…

  20. Lower Extremity Power Training in Elderly Subjects with Mobility Limitations: A Randomized Controlled Trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Background and Aims This study investigated whether high-velocity high-power training (POW) improved lower extremity muscle power and quality in functionally-limited elders greater than traditional slow-velocity progressive resistance training (STR). Methods Fifty-seven community-dwelling older adul...

  1. Lower extremity power training in elderly subjects with moderate mobility limitations: A randomized controlled trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Fifty-seven community-dwelling older adults were randomized to either high-velocity high-power training (POW), slow-velocity progressive resistance training (STR) or a control group of lower extremity stretching (CON). Training was performed three times per week for 12 weeks and subjects completed t...

  2. Serum thyroglobulin reference intervals in regions with adequate and more than adequate iodine intake.

    PubMed

    Wang, Zhaojun; Zhang, Hanyi; Zhang, Xiaowen; Sun, Jie; Han, Cheng; Li, Chenyan; Li, Yongze; Teng, Xiaochun; Fan, Chenling; Liu, Aihua; Shan, Zhongyan; Liu, Chao; Weng, Jianping; Teng, Weiping

    2016-11-01

    The purpose of this study was to establish normal thyroglobulin (Tg) reference intervals (RIs) in regions with adequate and more than adequate iodine intake according to the National Academy of Clinical Biochemistry (NACB) guidelines and to investigate the relationships between Tg and other factors.A total of 1317 thyroid disease-free adult subjects (578 men, 739 nonpregnant women) from 2 cities (Guangzhou and Nanjing) were enrolled in this retrospective, observational study. Each subject completed a questionnaire and underwent physical and ultrasonic examination. Serum Tg, thyroid-stimulating hormone (TSH), thyroid peroxidase antibody (TPOAb), Tg antibody (TgAb), and urinary iodine concentration (UIC) were measured. Reference groups were established on the basis of TSH levels: 0.5 to 2.0 and 0.27 to 4.2 mIU/L.The Tg RIs for Guangzhou and Nanjing were 1.6 to 30.0 and 1.9 to 25.8 ng/mL, respectively. No significant differences in Tg were found between genders or among different reference groups. Stepwise linear regression analyses showed that TgAb, thyroid volume, goiter, gender, age, and TSH levels were correlated with Tg.In adults from regions with adequate and more than adequate iodine intake, we found that Tg may be a suitable marker of iodine status; gender-specific Tg RI was unnecessary; there was no difference between Tg RIs in regions with adequate and more than adequate iodine intake; and the TSH criterion for selecting the Tg reference population could follow the local TSH reference rather than 0.5 to 2.0 mIU/L.

  3. Serum thyroglobulin reference intervals in regions with adequate and more than adequate iodine intake

    PubMed Central

    Wang, Zhaojun; Zhang, Hanyi; Zhang, Xiaowen; Sun, Jie; Han, Cheng; Li, Chenyan; Li, Yongze; Teng, Xiaochun; Fan, Chenling; Liu, Aihua; Shan, Zhongyan; Liu, Chao; Weng, Jianping; Teng, Weiping

    2016-01-01

    Abstract The purpose of this study was to establish normal thyroglobulin (Tg) reference intervals (RIs) in regions with adequate and more than adequate iodine intake according to the National Academy of Clinical Biochemistry (NACB) guidelines and to investigate the relationships between Tg and other factors. A total of 1317 thyroid disease-free adult subjects (578 men, 739 nonpregnant women) from 2 cities (Guangzhou and Nanjing) were enrolled in this retrospective, observational study. Each subject completed a questionnaire and underwent physical and ultrasonic examination. Serum Tg, thyroid-stimulating hormone (TSH), thyroid peroxidase antibody (TPOAb), Tg antibody (TgAb), and urinary iodine concentration (UIC) were measured. Reference groups were established on the basis of TSH levels: 0.5 to 2.0 and 0.27 to 4.2 mIU/L. The Tg RIs for Guangzhou and Nanjing were 1.6 to 30.0 and 1.9 to 25.8 ng/mL, respectively. No significant differences in Tg were found between genders or among different reference groups. Stepwise linear regression analyses showed that TgAb, thyroid volume, goiter, gender, age, and TSH levels were correlated with Tg. In adults from regions with adequate and more than adequate iodine intake, we found that Tg may be a suitable marker of iodine status; gender-specific Tg RI was unnecessary; there was no difference between Tg RIs in regions with adequate and more than adequate iodine intake; and the TSH criterion for selecting the Tg reference population could follow the local TSH reference rather than 0.5 to 2.0 mIU/L. PMID:27902589

  4. Ingestion of High Molecular Weight Carbohydrate Enhances Subsequent Repeated Maximal Power: A Randomized Controlled Trial.

    PubMed

    Oliver, Jonathan M; Almada, Anthony L; Van Eck, Leighsa E; Shah, Meena; Mitchell, Joel B; Jones, Margaret T; Jagim, Andrew R; Rowlands, David S

    2016-01-01

    Athletes in sports demanding repeat maximal work outputs frequently train concurrently utilizing sequential bouts of intense endurance and resistance training sessions. On a daily basis, maximal work within subsequent bouts may be limited by muscle glycogen availability. Recently, the ingestion of a unique high molecular weight (HMW) carbohydrate was found to increase glycogen re-synthesis rate and enhance work output during subsequent endurance exercise, relative to low molecular weight (LMW) carbohydrate ingestion. The effect of the HMW carbohydrate, however, on the performance of intense resistance exercise following prolonged-intense endurance training is unknown. Sixteen resistance trained men (23±3 years; 176.7±9.8 cm; 88.2±8.6 kg) participated in a double-blind, placebo-controlled, randomized 3-way crossover design comprising a muscle-glycogen depleting cycling exercise followed by ingestion of placebo (PLA), or 1.2 g•kg•bw-1 of LMW or HMW carbohydrate solution (10%) with blood sampling for 2-h post-ingestion. Thereafter, participants performed 5 sets of 10 maximal explosive repetitions of back squat (75% of 1RM). Compared to PLA, ingestion of HMW (4.9%, 90%CI 3.8%, 5.9%) and LMW (1.9%, 90%CI 0.8%, 3.0%) carbohydrate solutions substantially increased power output during resistance exercise, with the 3.1% (90% CI 4.3, 2.0%) almost certain additional gain in power after HMW-LMW ingestion attributed to higher movement velocity after force kinematic analysis (HMW-LMW 2.5%, 90%CI 1.4, 3.7%). Both carbohydrate solutions increased post-exercise plasma glucose, glucoregulatory and gut hormones compared to PLA, but differences between carbohydrates were unclear; thus, the underlying mechanism remains to be elucidated. Ingestion of a HMW carbohydrate following prolonged intense endurance exercise provides superior benefits to movement velocity and power output during subsequent repeated maximal explosive resistance exercise. This study was registered with

  5. Ingestion of High Molecular Weight Carbohydrate Enhances Subsequent Repeated Maximal Power: A Randomized Controlled Trial

    PubMed Central

    Oliver, Jonathan M.; Almada, Anthony L.; Van Eck, Leighsa E.; Shah, Meena; Mitchell, Joel B.; Jones, Margaret T.; Jagim, Andrew R.; Rowlands, David S.

    2016-01-01

    Athletes in sports demanding repeat maximal work outputs frequently train concurrently utilizing sequential bouts of intense endurance and resistance training sessions. On a daily basis, maximal work within subsequent bouts may be limited by muscle glycogen availability. Recently, the ingestion of a unique high molecular weight (HMW) carbohydrate was found to increase glycogen re-synthesis rate and enhance work output during subsequent endurance exercise, relative to low molecular weight (LMW) carbohydrate ingestion. The effect of the HMW carbohydrate, however, on the performance of intense resistance exercise following prolonged-intense endurance training is unknown. Sixteen resistance trained men (23±3 years; 176.7±9.8 cm; 88.2±8.6 kg) participated in a double-blind, placebo-controlled, randomized 3-way crossover design comprising a muscle-glycogen depleting cycling exercise followed by ingestion of placebo (PLA), or 1.2 g•kg•bw-1 of LMW or HMW carbohydrate solution (10%) with blood sampling for 2-h post-ingestion. Thereafter, participants performed 5 sets of 10 maximal explosive repetitions of back squat (75% of 1RM). Compared to PLA, ingestion of HMW (4.9%, 90%CI 3.8%, 5.9%) and LMW (1.9%, 90%CI 0.8%, 3.0%) carbohydrate solutions substantially increased power output during resistance exercise, with the 3.1% (90% CI 4.3, 2.0%) almost certain additional gain in power after HMW-LMW ingestion attributed to higher movement velocity after force kinematic analysis (HMW-LMW 2.5%, 90%CI 1.4, 3.7%). Both carbohydrate solutions increased post-exercise plasma glucose, glucoregulatory and gut hormones compared to PLA, but differences between carbohydrates were unclear; thus, the underlying mechanism remains to be elucidated. Ingestion of a HMW carbohydrate following prolonged intense endurance exercise provides superior benefits to movement velocity and power output during subsequent repeated maximal explosive resistance exercise. This study was registered with

  6. Adequate mathematical modelling of environmental processes

    NASA Astrophysics Data System (ADS)

    Chashechkin, Yu. D.

    2012-04-01

    In environmental observations and laboratory visualization both large scale flow components like currents, jets, vortices, waves and a fine structure are registered (different examples are given). The conventional mathematical modeling both analytical and numerical is directed mostly on description of energetically important flow components. The role of a fine structures is still remains obscured. A variety of existing models makes it difficult to choose the most adequate and to estimate mutual assessment of their degree of correspondence. The goal of the talk is to give scrutiny analysis of kinematics and dynamics of flows. A difference between the concept of "motion" as transformation of vector space into itself with a distance conservation and the concept of "flow" as displacement and rotation of deformable "fluid particles" is underlined. Basic physical quantities of the flow that are density, momentum, energy (entropy) and admixture concentration are selected as physical parameters defined by the fundamental set which includes differential D'Alembert, Navier-Stokes, Fourier's and/or Fick's equations and closing equation of state. All of them are observable and independent. Calculations of continuous Lie groups shown that only the fundamental set is characterized by the ten-parametric Galilelian groups reflecting based principles of mechanics. Presented analysis demonstrates that conventionally used approximations dramatically change the symmetries of the governing equations sets which leads to their incompatibility or even degeneration. The fundamental set is analyzed taking into account condition of compatibility. A high order of the set indicated on complex structure of complete solutions corresponding to physical structure of real flows. Analytical solutions of a number problems including flows induced by diffusion on topography, generation of the periodic internal waves a compact sources in week-dissipative media as well as numerical solutions of the same

  7. The International Remote Monitoring Project: Results of the Swedish Nuclear Power Facility field trial

    SciTech Connect

    Johnson, C.S.; af Ekenstam, G.; Sallstrom, M.

    1995-07-01

    The Swedish Nuclear Power Inspectorate (SKI) and the US Department of Energy (DOE) sponsored work on a Remote Monitoring System (RMS) that was installed in August 1994 at the Barseback Works north of Malmo, Sweden. The RMS was designed to test the front end detection concept that would be used for unattended remote monitoring activities. Front end detection reduces the number of video images recorded and provides additional sensor verification of facility operations. The function of any safeguards Containment and Surveillance (C/S) system is to collect information which primarily is images that verify the operations at a nuclear facility. Barseback is ideal to test the concept of front end detection since most activities of safeguards interest is movement of spent fuel which occurs once a year. The RMS at Barseback uses a network of nodes to collect data from microwave motion detectors placed to detect the entrance and exit of spent fuel casks through a hatch. A video system using digital compression collects digital images and stores them on a hard drive and a digital optical disk. Data and images from the storage area are remotely monitored via telephone from Stockholm, Sweden and Albuquerque, NM, USA. These remote monitoring stations operated by SKI and SNL respectively, can retrieve data and images from the RMS computer at the Barseback Facility. The data and images are encrypted before transmission. This paper presents details of the RMS and test results of this approach to front end detection of safeguard activities.

  8. Bias, precision and statistical power of analysis of covariance in the analysis of randomized trials with baseline imbalance: a simulation study

    PubMed Central

    2014-01-01

    Background Analysis of variance (ANOVA), change-score analysis (CSA) and analysis of covariance (ANCOVA) respond differently to baseline imbalance in randomized controlled trials. However, no empirical studies appear to have quantified the differential bias and precision of estimates derived from these methods of analysis, and their relative statistical power, in relation to combinations of levels of key trial characteristics. This simulation study therefore examined the relative bias, precision and statistical power of these three analyses using simulated trial data. Methods 126 hypothetical trial scenarios were evaluated (126 000 datasets), each with continuous data simulated by using a combination of levels of: treatment effect; pretest-posttest correlation; direction and magnitude of baseline imbalance. The bias, precision and power of each method of analysis were calculated for each scenario. Results Compared to the unbiased estimates produced by ANCOVA, both ANOVA and CSA are subject to bias, in relation to pretest-posttest correlation and the direction of baseline imbalance. Additionally, ANOVA and CSA are less precise than ANCOVA, especially when pretest-posttest correlation ≥ 0.3. When groups are balanced at baseline, ANCOVA is at least as powerful as the other analyses. Apparently greater power of ANOVA and CSA at certain imbalances is achieved in respect of a biased treatment effect. Conclusions Across a range of correlations between pre- and post-treatment scores and at varying levels and direction of baseline imbalance, ANCOVA remains the optimum statistical method for the analysis of continuous outcomes in RCTs, in terms of bias, precision and statistical power. PMID:24712304

  9. Exploring the performance reserve: Effect of different magnitudes of power output deception on 4,000 m cycling time-trial performance

    PubMed Central

    Stone, Mark R.; Thomas, Kevin; Wilkinson, Michael; Stevenson, Emma; St. Clair Gibson, Alan; Jones, Andrew M.; Thompson, Kevin G.

    2017-01-01

    Purpose The aim of the present study was to investigate whether a magnitude of deception of 5% in power output would lead to a greater reduction in the amount of time taken for participants to complete a 4000 m cycling TT than a magnitude of deception of 2% in power output, which we have previously shown can lead to a small change in 4000 m cycling TT performance. Methods Ten trained male cyclists completed four, 4000 m cycling TTs. The first served as a habituation and the second as a baseline for future trials. During trials three and four participants raced against a pacer which was set, in a randomized order, at a mean power output equal to 2% (+2% TT) or 5% (+5% TT) higher than their baseline performance. However participants were misled into believing that the power output of the pacer was an accurate representation of their baseline performance on both occasions. Cardiorespiratory responses were recorded throughout each TT, and used to estimate energy contribution from aerobic and anaerobic metabolism. Results Participants were able to finish the +2% TT in a significantly shorter duration than at baseline (p = 0.01), with the difference in performance likely attributable to a greater anaerobic contribution to total power output (p = 0.06). There was no difference in performance between the +5% TT and +2% TT or baseline trials. Conclusions Results suggest that a performance reserve is conserved, involving anaerobic energy contribution, which can be utilised given a belief that the exercise will be sustainable however there is an upper limit to how much deception can be tolerated. These findings have implications for performance enhancement in athletes and for our understanding of the nature of fatigue during high-intensity exercise. PMID:28278174

  10. 40 CFR 716.25 - Adequate file search.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Adequate file search. 716.25 Section 716.25 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT HEALTH AND SAFETY DATA REPORTING General Provisions § 716.25 Adequate file search. The scope of...

  11. 40 CFR 716.25 - Adequate file search.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Adequate file search. 716.25 Section 716.25 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT HEALTH AND SAFETY DATA REPORTING General Provisions § 716.25 Adequate file search. The scope of...

  12. "Something Adequate"? In Memoriam Seamus Heaney, Sister Quinlan, Nirbhaya

    ERIC Educational Resources Information Center

    Parker, Jan

    2014-01-01

    Seamus Heaney talked of poetry's responsibility to represent the "bloody miracle", the "terrible beauty" of atrocity; to create "something adequate". This article asks, what is adequate to the burning and eating of a nun and the murderous gang rape and evisceration of a medical student? It considers Njabulo Ndebele's…

  13. 40 CFR 716.25 - Adequate file search.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Adequate file search. 716.25 Section... ACT HEALTH AND SAFETY DATA REPORTING General Provisions § 716.25 Adequate file search. The scope of a person's responsibility to search records is limited to records in the location(s) where the...

  14. 40 CFR 51.354 - Adequate tools and resources.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 2 2013-07-01 2013-07-01 false Adequate tools and resources. 51.354... Requirements § 51.354 Adequate tools and resources. (a) Administrative resources. The program shall maintain the administrative resources necessary to perform all of the program functions including...

  15. 40 CFR 51.354 - Adequate tools and resources.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 2 2014-07-01 2014-07-01 false Adequate tools and resources. 51.354... Requirements § 51.354 Adequate tools and resources. (a) Administrative resources. The program shall maintain the administrative resources necessary to perform all of the program functions including...

  16. 40 CFR 51.354 - Adequate tools and resources.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 2 2010-07-01 2010-07-01 false Adequate tools and resources. 51.354... Requirements § 51.354 Adequate tools and resources. (a) Administrative resources. The program shall maintain the administrative resources necessary to perform all of the program functions including...

  17. 40 CFR 51.354 - Adequate tools and resources.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 2 2011-07-01 2011-07-01 false Adequate tools and resources. 51.354... Requirements § 51.354 Adequate tools and resources. (a) Administrative resources. The program shall maintain the administrative resources necessary to perform all of the program functions including...

  18. 40 CFR 51.354 - Adequate tools and resources.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 2 2012-07-01 2012-07-01 false Adequate tools and resources. 51.354... Requirements § 51.354 Adequate tools and resources. (a) Administrative resources. The program shall maintain the administrative resources necessary to perform all of the program functions including...

  19. 9 CFR 305.3 - Sanitation and adequate facilities.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Sanitation and adequate facilities. 305.3 Section 305.3 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF... OF VIOLATION § 305.3 Sanitation and adequate facilities. Inspection shall not be inaugurated if...

  20. 9 CFR 305.3 - Sanitation and adequate facilities.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Sanitation and adequate facilities. 305.3 Section 305.3 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF... OF VIOLATION § 305.3 Sanitation and adequate facilities. Inspection shall not be inaugurated if...

  1. 9 CFR 305.3 - Sanitation and adequate facilities.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Sanitation and adequate facilities. 305.3 Section 305.3 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF... OF VIOLATION § 305.3 Sanitation and adequate facilities. Inspection shall not be inaugurated if...

  2. 9 CFR 305.3 - Sanitation and adequate facilities.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Sanitation and adequate facilities. 305.3 Section 305.3 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF... OF VIOLATION § 305.3 Sanitation and adequate facilities. Inspection shall not be inaugurated if...

  3. 9 CFR 305.3 - Sanitation and adequate facilities.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Sanitation and adequate facilities. 305.3 Section 305.3 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF... OF VIOLATION § 305.3 Sanitation and adequate facilities. Inspection shall not be inaugurated if...

  4. 21 CFR 201.5 - Drugs; adequate directions for use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drugs; adequate directions for use. 201.5 Section 201.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.5 Drugs; adequate directions for use....

  5. Region 9: Arizona Adequate Letter (10/14/2003)

    EPA Pesticide Factsheets

    This is a letter from Jack P. Broadben,. Director, to Nancy Wrona and Dennis Smith informing them that Maricopa County's motor vehicle emissions budgets in the 2003 MAGCO Maintenance Plan are adequate for transportation conformity purposes.

  6. Region 6: Texas Adequate Letter (4/16/2010)

    EPA Pesticide Factsheets

    This letter from EPA to Texas Commission on Environmental Quality determined 2021 motor vehicle emission budgets for nitrogen oxides (NOx) and volatile organic compounds (VOCs) for Beaumont/Port Arthur area adequate for transportation conformity purposes

  7. Region 2: New Jersey Adequate Letter (5/23/2002)

    EPA Pesticide Factsheets

    This April 22, 2002 letter from EPA to the New Jersey Department of Environmental Protection determined 2007 and 2014 Carbon Monoxide (CO) Mobile Source Emissions Budgets adequate for transportation conformity purposes and will be announced in the Federal

  8. Region 8: Colorado Adequate Letter (10/29/2001)

    EPA Pesticide Factsheets

    This letter from EPA to Colorado Department of Public Health and Environment determined Denvers' particulate matter (PM10) maintenance plan for Motor Vehicle Emissions Budgets adequate for transportation conformity purposes.

  9. Region 1: New Hampshire Adequate Letter (8/12/2008)

    EPA Pesticide Factsheets

    This July 9, 2008 letter from EPA to the New Hampshire Department of Environmental Services, determined the 2009 Motor Vehicle Emissions Budgets (MVEBs) are adequate for transportation conformity purposes and will be announced in the Federal Register (FR).

  10. Region 8: Colorado Adequate Letter (1/20/2004)

    EPA Pesticide Factsheets

    This letter from EPA to Colorado Department of Public Health and Environment determined Greeleys' Carbon Monoxide (CO) maintenance plan for Motor Vehicle Emissions Budgets adequate for transportation conformity purposes and will be announced in the FR.

  11. Region 8: Utah Adequate Letter (6/10/2005)

    EPA Pesticide Factsheets

    This letter from EPA to Utah Department of Environmental Quality determined Salt Lake Citys' and Ogdens' Carbon Monoxide (CO) maintenance plan for Motor Vehicle Emissions Budgets adequate for transportation conformity purposes.

  12. 15 CFR 970.404 - Adequate exploration plan.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... ENVIRONMENTAL DATA SERVICE DEEP SEABED MINING REGULATIONS FOR EXPLORATION LICENSES Certification of Applications § 970.404 Adequate exploration plan. Before he may certify an application, the Administrator must...

  13. 15 CFR 970.404 - Adequate exploration plan.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... ENVIRONMENTAL DATA SERVICE DEEP SEABED MINING REGULATIONS FOR EXPLORATION LICENSES Certification of Applications § 970.404 Adequate exploration plan. Before he may certify an application, the Administrator must...

  14. 15 CFR 970.404 - Adequate exploration plan.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... ENVIRONMENTAL DATA SERVICE DEEP SEABED MINING REGULATIONS FOR EXPLORATION LICENSES Certification of Applications § 970.404 Adequate exploration plan. Before he may certify an application, the Administrator must...

  15. 15 CFR 970.404 - Adequate exploration plan.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... ENVIRONMENTAL DATA SERVICE DEEP SEABED MINING REGULATIONS FOR EXPLORATION LICENSES Certification of Applications § 970.404 Adequate exploration plan. Before he may certify an application, the Administrator must...

  16. 15 CFR 970.404 - Adequate exploration plan.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... ENVIRONMENTAL DATA SERVICE DEEP SEABED MINING REGULATIONS FOR EXPLORATION LICENSES Certification of Applications § 970.404 Adequate exploration plan. Before he may certify an application, the Administrator must...

  17. Region 6: New Mexico Adequate Letter (8/21/2003)

    EPA Pesticide Factsheets

    This is a letter from Carl Edlund, Director, to Alfredo Santistevan regarding MVEB's contained in the latest revision to the Albuquerque Carbon Monoxide State Implementation Plan (SIP) are adequate for transportation conformity purposes.

  18. 10 CFR 1304.114 - Responsibility for maintaining adequate safeguards.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... contained in a system of records are adequately trained to protect the security and privacy of such records..., by degaussing or by overwriting with the appropriate security software, in accordance...

  19. 4 CFR 200.14 - Responsibility for maintaining adequate safeguards.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... require access to and use of records contained in a system of records are adequately trained to protect... with the appropriate security software, in accordance with regulations of the Archivist of the...

  20. 10 CFR 1304.114 - Responsibility for maintaining adequate safeguards.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... contained in a system of records are adequately trained to protect the security and privacy of such records..., by degaussing or by overwriting with the appropriate security software, in accordance...

  1. 4 CFR 200.14 - Responsibility for maintaining adequate safeguards.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... require access to and use of records contained in a system of records are adequately trained to protect... with the appropriate security software, in accordance with regulations of the Archivist of the...

  2. 10 CFR 1304.114 - Responsibility for maintaining adequate safeguards.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... contained in a system of records are adequately trained to protect the security and privacy of such records..., by degaussing or by overwriting with the appropriate security software, in accordance...

  3. 10 CFR 1304.114 - Responsibility for maintaining adequate safeguards.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... contained in a system of records are adequately trained to protect the security and privacy of such records..., by degaussing or by overwriting with the appropriate security software, in accordance...

  4. 4 CFR 200.14 - Responsibility for maintaining adequate safeguards.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... require access to and use of records contained in a system of records are adequately trained to protect... with the appropriate security software, in accordance with regulations of the Archivist of the...

  5. Region 9: Nevada Adequate Letter (3/30/2006)

    EPA Pesticide Factsheets

    This is a letter from Deborah Jordan, Director, to Leo M. Drozdoff regarding Nevada's motor vehicle emissions budgets in the 2005 Truckee Meadows CO Redesignation Request and Maintenance Plan are adequate for transportation conformity decisions.

  6. The Relieving Effects of BrainPower Advanced, a Dietary Supplement, in Older Adults with Subjective Memory Complaints: A Randomized, Double-Blind, Placebo-Controlled Trial

    PubMed Central

    Zhu, Jingfen; Shi, Rong; Chen, Su; Dai, Lihua; Shen, Tian; Feng, Yi; Gu, Pingping; Shariff, Mina; Nguyen, Tuong; Ye, Yeats; Rao, Jianyu; Xing, Guoqiang

    2016-01-01

    Subjective memory complaints (SMCs) are common in older adults that can often predict further cognitive impairment. No proven effective agents are available for SMCs. The effect of BrainPower Advanced, a dietary supplement consisting of herbal extracts, nutrients, and vitamins, was evaluated in 98 volunteers with SMCs, averaging 67 years of age (47–88), in a randomized, double-blind, placebo-controlled trial. Subjective hypomnesis/memory loss (SML) and attention/concentration deficits (SAD) were evaluated before and after 12-week supplementation of BrainPower Advanced capsules (n = 47) or placebo (n = 51), using a 5-point memory questionnaire (1 = no/slight, 5 = severe). Objective memory function was evaluated using 3 subtests of visual/audio memory, abstraction, and memory recall that gave a combined total score. The BrainPower Advanced group had more cases of severe SML (severity ⩾ 3) (44/47) and severe SAD (43/47) than the placebo group (39/51 and 37/51, < 0.05, < 0.05, resp.) before the treatment. BrainPower Advanced intervention, however, improved a greater proportion of the severe SML (29.5%)(13/44) (P < 0.01) and SAD (34.9%)(15/43)(P < 0.01) than placebo (5.1% (2/39) and 13.5% (5/37), resp.). Thus, 3-month BrainPower Advanced supplementation appears to be beneficial to older adults with SMCs. PMID:27190539

  7. Improved statistical power of Alzheimer clinical trials by item-response theory: proof of concept by application to the activities of daily living scale.

    PubMed

    Ard, M Colin; Galasko, Douglas R; Edland, Steven D

    2013-01-01

    Discovery of effective treatment for Alzheimer disease (AD) depends upon the availability of outcome measures that exhibit good sensitivity to rates of longitudinal decline on global functional performance. The Alzheimer's Disease Cooperative Study-Activities of Daily Living inventory (ADCS-ADL) is a frequently used functional endpoint in clinical trials for AD that assesses patient functional ability on the basis of informant ratings of patient performance on a variety of everyday tasks. Previous research has shown that the items comprising the ADCS-ADL are sensitive to characteristic longitudinal trajectories in AD. However, standard procedures for combining information from individual items into an overall test score may not make full use of the information provided by informant responses. The current study explored an application of item-response theory (IRT) techniques to the calculation of test scores on the ADCS-ADL. Using data from 2 ADCS clinical trials on mild-to-moderate AD patients we found that IRT based scoring increased sensitivity to change in functional ability and improved prospective statistical power of the ADCS-ADL as an outcome measure in clinical trials.

  8. Power Difference and Risk Perception: Mapping Vulnerability within the Decision Process of Pregnant Women towards Clinical Trial Participation in an Urban Middle-Income Setting.

    PubMed

    Den Hollander, Geerte C; Browne, Joyce L; Arhinful, Daniel; van der Graaf, Rieke; Klipstein-Grobusch, Kerstin

    2016-10-20

    To address the burden of maternal morbidity and mortality in low- and middle-income countries (LMICs), research with pregnant women in these settings is increasingly common. Pregnant women in LMIC-context may experience vulnerability related to giving consent to participate in a clinical trial. To recognize possible layers of vulnerability this study aims to identify factors that influence the decision process towards clinical trial participation of pregnant women in an urban middle-income setting. This qualitative research used participant observation, in-depth interviews, and focus group discussion with medical staff and pregnant women eligible for trial participation, at a regional hospital in Accra, Ghana. Besides lack of familiarity with modern scientific concepts, specific factors influencing the decision-making process were identified. These include a wide power difference between health provider and patient, and a different perception of risk through externalization of responsibility of risk management within a religious context as well as a context shaped by authority. Also, therapeutic misconception was observed. The combination of these factors ensued women to rely on the opinion of the medical professional, rather than being guided by their own motivation to participation. Although being a (pregnant) woman per se should not render the label of being vulnerable, this study shows there are factors that influence the decision process of pregnant woman towards trial participation in a LMIC context that can result in vulnerability. The identification of context-specific factors that can create vulnerability facilitates adaptation of the design and conduct of research in a culturally competent manner.

  9. A best practice fall prevention exercise program to improve balance, strength / power, and psychosocial health in older adults: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background With increasing age neuromuscular deficits (e.g., sarcopenia) may result in impaired physical performance and an increased risk for falls. Prominent intrinsic fall-risk factors are age-related decreases in balance and strength / power performance as well as cognitive decline. Additional studies are needed to develop specifically tailored exercise programs for older adults that can easily be implemented into clinical practice. Thus, the objective of the present trial is to assess the effects of a fall prevention program that was developed by an interdisciplinary expert panel on measures of balance, strength / power, body composition, cognition, psychosocial well-being, and falls self-efficacy in healthy older adults. Additionally, the time-related effects of detraining are tested. Methods/Design Healthy old people (n = 54) between the age of 65 to 80 years will participate in this trial. The testing protocol comprises tests for the assessment of static / dynamic steady-state balance (i.e., Sharpened Romberg Test, instrumented gait analysis), proactive balance (i.e., Functional Reach Test; Timed Up and Go Test), reactive balance (i.e., perturbation test during bipedal stance; Push and Release Test), strength (i.e., hand grip strength test; Chair Stand Test), and power (i.e., Stair Climb Power Test; countermovement jump). Further, body composition will be analysed using a bioelectrical impedance analysis system. In addition, questionnaires for the assessment of psychosocial (i.e., World Health Organisation Quality of Life Assessment-Bref), cognitive (i.e., Mini Mental State Examination), and fall risk determinants (i.e., Fall Efficacy Scale – International) will be included in the study protocol. Participants will be randomized into two intervention groups or the control / waiting group. After baseline measures, participants in the intervention groups will conduct a 12-week balance and strength / power exercise intervention 3 times per week, with

  10. The risky reliance on small surrogate endpoint studies when planning a large prevention trial.

    PubMed

    Baker, Stuart G; Kramer, Barnett S

    2013-02-01

    The definitive evaluation of treatment to prevent a chronic disease with low incidence in middle age, such as cancer or cardiovascular disease, requires a trial with a large sample size of perhaps 20,000 or more. To help decide whether to implement a large true endpoint trial, investigators first typically estimate the effect of treatment on a surrogate endpoint in a trial with a greatly reduced sample size of perhaps 200 subjects. If investigators reject the null hypothesis of no treatment effect in the surrogate endpoint trial they implicitly assume they would likely correctly reject the null hypothesis of no treatment effect for the true endpoint. Surrogate endpoint trials are generally designed with adequate power to detect an effect of treatment on surrogate endpoint. However, we show that a small surrogate endpoint trial is more likely than a large surrogate endpoint trial to give a misleading conclusion about the beneficial effect of treatment on true endpoint, which can lead to a faulty (and costly) decision about implementing a large true endpoint prevention trial. If a small surrogate endpoint trial rejects the null hypothesis of no treatment effect, an intermediate-sized surrogate endpoint trial could be a useful next step in the decision-making process for launching a large true endpoint prevention trial.

  11. Regulatory requirements for providing adequate veterinary care to research animals.

    PubMed

    Pinson, David M

    2013-09-01

    Provision of adequate veterinary care is a required component of animal care and use programs in the United States. Program participants other than veterinarians, including non-medically trained research personnel and technicians, also provide veterinary care to animals, and administrators are responsible for assuring compliance with federal mandates regarding adequate veterinary care. All program participants therefore should understand the regulatory requirements for providing such care. The author provides a training primer on the US regulatory requirements for the provision of veterinary care to research animals. Understanding the legal basis and conditions of a program of veterinary care will help program participants to meet the requirements advanced in the laws and policies.

  12. Comparability and Reliability Considerations of Adequate Yearly Progress

    ERIC Educational Resources Information Center

    Maier, Kimberly S.; Maiti, Tapabrata; Dass, Sarat C.; Lim, Chae Young

    2012-01-01

    The purpose of this study is to develop an estimate of Adequate Yearly Progress (AYP) that will allow for reliable and valid comparisons among student subgroups, schools, and districts. A shrinkage-type estimator of AYP using the Bayesian framework is described. Using simulated data, the performance of the Bayes estimator will be compared to…

  13. 13 CFR 107.200 - Adequate capital for Licensees.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... operate actively in accordance with your Articles and within the context of your business plan, as... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Adequate capital for Licensees. 107.200 Section 107.200 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION SMALL...

  14. 13 CFR 107.200 - Adequate capital for Licensees.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... operate actively in accordance with your Articles and within the context of your business plan, as... 13 Business Credit and Assistance 1 2011-01-01 2011-01-01 false Adequate capital for Licensees. 107.200 Section 107.200 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION SMALL...

  15. Is the Stock of VET Skills Adequate? Assessment Methodologies.

    ERIC Educational Resources Information Center

    Blandy, Richard; Freeland, Brett

    In Australia and elsewhere, four approaches have been used to determine whether stocks of vocational education and training (VET) skills are adequate to meet industry needs. The four methods are as follows: (1) the manpower requirements approach; (2) the international, national, and industry comparisons approach; (3) the labor market analysis…

  16. Do Beginning Teachers Receive Adequate Support from Their Headteachers?

    ERIC Educational Resources Information Center

    Menon, Maria Eliophotou

    2012-01-01

    The article examines the problems faced by beginning teachers in Cyprus and the extent to which headteachers are considered to provide adequate guidance and support to them. Data were collected through interviews with 25 school teachers in Cyprus, who had recently entered teaching (within 1-5 years) in public primary schools. According to the…

  17. 13 CFR 108.200 - Adequate capital for NMVC Companies.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Companies. 108.200 Section 108.200 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION NEW MARKETS VENTURE CAPITAL (âNMVCâ) PROGRAM Qualifications for the NMVC Program Capitalizing A Nmvc Company § 108.200 Adequate capital for NMVC Companies. You must meet the requirements of §§ 108.200-108.230 in order...

  18. 13 CFR 108.200 - Adequate capital for NMVC Companies.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Companies. 108.200 Section 108.200 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION NEW MARKETS VENTURE CAPITAL (âNMVCâ) PROGRAM Qualifications for the NMVC Program Capitalizing A Nmvc Company § 108.200 Adequate capital for NMVC Companies. You must meet the requirements of §§ 108.200-108.230 in order...

  19. 13 CFR 108.200 - Adequate capital for NMVC Companies.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Companies. 108.200 Section 108.200 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION NEW MARKETS VENTURE CAPITAL (âNMVCâ) PROGRAM Qualifications for the NMVC Program Capitalizing A Nmvc Company § 108.200 Adequate capital for NMVC Companies. You must meet the requirements of §§ 108.200-108.230 in order...

  20. 13 CFR 108.200 - Adequate capital for NMVC Companies.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Companies. 108.200 Section 108.200 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION NEW MARKETS VENTURE CAPITAL (âNMVCâ) PROGRAM Qualifications for the NMVC Program Capitalizing A Nmvc Company § 108.200 Adequate capital for NMVC Companies. You must meet the requirements of §§ 108.200-108.230 in order...

  1. 13 CFR 108.200 - Adequate capital for NMVC Companies.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Companies. 108.200 Section 108.200 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION NEW MARKETS VENTURE CAPITAL (âNMVCâ) PROGRAM Qualifications for the NMVC Program Capitalizing A Nmvc Company § 108.200 Adequate capital for NMVC Companies. You must meet the requirements of §§ 108.200-108.230 in order...

  2. Understanding Your Adequate Yearly Progress (AYP), 2011-2012

    ERIC Educational Resources Information Center

    Missouri Department of Elementary and Secondary Education, 2011

    2011-01-01

    The "No Child Left Behind Act (NCLB) of 2001" requires all schools, districts/local education agencies (LEAs) and states to show that students are making Adequate Yearly Progress (AYP). NCLB requires states to establish targets in the following ways: (1) Annual Proficiency Target; (2) Attendance/Graduation Rates; and (3) Participation…

  3. 34 CFR 200.13 - Adequate yearly progress in general.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 1 2011-07-01 2011-07-01 false Adequate yearly progress in general. 200.13 Section 200.13 Education Regulations of the Offices of the Department of Education OFFICE OF ELEMENTARY AND SECONDARY EDUCATION, DEPARTMENT OF EDUCATION TITLE I-IMPROVING THE ACADEMIC ACHIEVEMENT OF THE...

  4. 34 CFR 200.13 - Adequate yearly progress in general.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 34 Education 1 2013-07-01 2013-07-01 false Adequate yearly progress in general. 200.13 Section 200.13 Education Regulations of the Offices of the Department of Education OFFICE OF ELEMENTARY AND SECONDARY EDUCATION, DEPARTMENT OF EDUCATION TITLE I-IMPROVING THE ACADEMIC ACHIEVEMENT OF THE...

  5. Region 9: Arizona Adequate Letter (11/1/2001)

    EPA Pesticide Factsheets

    This is a letter from Jack P. Broadbent, Director, Air Division to Nancy Wrona and James Bourney informing them of the adequacy of Revised MAG 1999 Serious Area Carbon Monoxide Plan and that the MAG CO Plan is adequate for Maricopa County.

  6. Implementing Coping Power Adapted as a Universal Prevention Program in Italian Primary Schools: a Randomized Control Trial.

    PubMed

    Muratori, Pietro; Bertacchi, Iacopo; Giuli, Consuelo; Nocentini, Annalaura; Lochman, John E

    2016-09-24

    Behavioral problems in schools can cause serious harm to the emotional and social well-being of students and limit their ability to achieve their full academic potential. A prior pilot study on the universal application of Coping Power showed a significant decrease in the hyperactivity behaviors of five classes. The next step was to test whether Coping Power Universal could be successfully implemented by teachers in a variety of Italian schools. The sample involved 40 third- and fourth-grade classes (901 students) from public schools located in three Italian cities. Twenty classes were randomly assigned to Coping Power Universal, and 20 classes were randomly assigned to the control group, which received the strictly standard academic curriculum of Italian elementary schools. At each assessment period, the teachers completed the Strengths and Difficulties Questionnaire. The findings showed a significant reduction in hyperactive and inattention behaviors and conduct problems and emotional symptoms in the intervention classes compared with the control classes. This study suggests that Coping Power model can be delivered in school settings at both universal and targeted prevention levels and that in this multi-tiered prevention model, teachers can learn a set of intervention skills which can be delivered with flexibility, thus reducing some of the complexity and costs of schools using multiple interventions.

  7. Overview of phase IV clinical trials for postmarket drug safety surveillance: a status report from the ClinicalTrials.gov registry

    PubMed Central

    Zhang, Xinji; Zhang, Yuan; Ye, Xiaofei; Guo, Xiaojing; Zhang, Tianyi; He, Jia

    2016-01-01

    Objective Phase IV trials are often used to investigate drug safety after approval. However, little is known about the characteristics of contemporary phase IV clinical trials and whether these studies are of sufficient quality to advance medical knowledge in pharmacovigilance. We aimed to determine the fundamental characteristics of phase IV clinical trials that evaluated drug safety using the ClinicalTrials.gov registry data. Methods A data set of 19 359 phase IV clinical studies registered in ClinicalTrials.gov was downloaded. The characteristics of the phase IV trials focusing on safety only were compared with those evaluating both safety and efficacy. We also compared the characteristics of the phase IV trials in three major therapeutic areas (cardiovascular diseases, mental health and oncology). Multivariable logistic regression was used to evaluate factors associated with the use of blinding and randomisation. Results A total of 4772 phase IV trials were identified, including 330 focusing on drug safety alone and 4392 evaluating both safety and efficacy. Most of the phase IV trials evaluating drug safety (75.9%) had enrolment <300 with 96.5% <3000. Among these trials, 8.2% were terminated or withdrawn. Factors associated with the use of blinding and randomisation included the intervention model, clinical specialty and lead sponsor. Conclusions Phase IV trials evaluating drug safety in the ClinicalTrials.gov registry were dominated by small trials that might not have sufficient power to detect less common adverse events. An adequate sample size should be emphasised for phase IV trials with safety surveillance as main task. PMID:27881517

  8. Phase I trial of an implanted battery-powered, programmable drug delivery system for continuous doxorubicin administration.

    PubMed

    Vogelzang, N J; Ruane, M; DeMeester, T R

    1985-03-01

    A second generation, implantable drug administration device (DAD, Medtronic, Inc, Minneapolis) which contains a 20-mL drug reservoir, a lithium-thionyl-chloride battery, a peristaltic roller pump, a microprocessor circuit, and an acoustic transducer has entered clinical trials. After surgical placement, drug is entered into and removed from the DAD percutaneously through a Silastic "fill port" using a standard gauge needle and syringe. The pump is noninvasively programmed using a hand-held telemetry wand to administer the drug in a continuous infusion, bolus, or bolus-delay mode. Because of the apparent improved therapeutic index of continuous-infusion doxorubicin (CID), a phase I trial of the Medtronic DAD with CID was begun. Thirteen pumps in 13 patients have functioned for a median of 153 days (range, 11 to 395 days) with one pump still functioning. Four pumps ceased function at 170, 278, 331, and 370 days, respectively; there was a catheter-tip clot on one of the pumps that later malfunctioned. All other pumps functioned until the death of the respective patients. In 84 pump refills, without drug extravasation, the median drug delivery error (actual residual volume--calculated residual volume/calculated residual volume X 100%) was 14%. Doxorubicin was compatible with all components of the drug pathway and did not significantly decompose during two weeks in the drug reservoir. The starting dose of CID was 2.0 mg/m2/d and the maximum tolerated dose was 4.1 mg/m2/d (range, 3.5 to 5.5). A median cumulative doxorubicin dose of 244 mg/m2 per patient (range, 10 to 583 mg/m2) has been infused.(ABSTRACT TRUNCATED AT 250 WORDS)

  9. Army General Fund Adjustments Not Adequately Documented or Supported

    DTIC Science & Technology

    2016-07-26

    statements were unreliable and lacked an adequate audit trail. Furthermore, DoD and Army managers could not rely on the data in their accounting...risk that AGF financial statements will be materially misstated and the Army will not achieve audit readiness by the congressionally mandated...and $6.5 trillion in yearend adjustments made to Army General Fund data during FY 2015 financial statement compilation. We conducted this audit in

  10. Field trial of active remote sensing using a high-power short-wave infrared supercontinuum laser.

    PubMed

    Alexander, Vinay V; Shi, Zhennan; Islam, Mohammed N; Ke, Kevin; Kalinchenko, Galina; Freeman, Michael J; Ifarraguerri, Agustin; Meola, Joseph; Absi, Anthony; Leonard, James; Zadnik, Jerome A; Szalkowski, Anthony S; Boer, Gregory J

    2013-09-20

    Field trial results of a 5 W all-fiber broadband supercontinuum (SC) laser covering the short-wave infrared (SWIR) wavelength bands from ~1.55 to 2.35 μm are presented. The SC laser is kept on a 12 story tower at the Wright Patterson Air Force Base and propagated through the atmosphere to a target 1.6 km away. Beam quality of the SC laser after propagating through 1.6 km is studied using a SWIR camera and show a near diffraction limited beam with an M(2) value of <1.3. The SC laser is used as the illumination source to perform spectral reflectance measurements of various samples at 1.6 km, and the results are seen to be in good agreement with in-lab measurements using a conventional lamp source. Spectral stability measurements are performed after atmospheric propagation through 1.6 km and show a relative variability of ~4%-8% across the spectrum depending on the atmospheric turbulence effects. Spectral stability measurements are also performed in-lab and show a relative variability of <0.6% across the spectrum.

  11. Cholesterol trials and mortality.

    PubMed

    Warren, John B; Dimmitt, Simon B; Stampfer, Hans G

    2016-07-01

    An overview of clinical trials can reveal a class effect on mortality that is not apparent from individual trials. Most large trials of lipid pharmacotherapy are not powered to detect differences in mortality and instead assess efficacy with composite cardiovascular endpoints. We illustrate the importance of all-cause mortality data by comparing survival in three different sets of the larger controlled lipid trials that underpin meta-analyses. These trials are for fibrates and statins. Fibrate treatment in five of the six main trials was associated with a decrease in survival, one fibrate trial showed a non-significant reduction in mortality that can be explained by a different target population. In secondary prevention, statin treatment increased survival in all five of the main trials, absolute mean increase ranged from 0.43% to 3.33%, the median change was 1.75%, which occurred in the largest trial. In primary prevention, statin treatment increased survival in six of the seven main trials, absolute mean change in survival ranged from -0.09% to 0.89%, median 0.49%. Composite safety endpoints are rare in these trials. The failure to address composite safety endpoints in most lipid trials precludes a balanced summary of risk-benefit when a composite has been used for efficacy. Class effects on survival provide informative summaries of the risk-benefit of lipid pharmacotherapy. We consider that the presentation of key mortality/survival data adds to existing meta-analyses to aid personal treatment decisions.

  12. Combined strength and power training in high-level amateur football during the competitive season: a randomised-controlled trial.

    PubMed

    Faude, Oliver; Roth, Ralf; Di Giovine, Dario; Zahner, Lukas; Donath, Lars

    2013-01-01

    We aimed to analyse the effects of combined strength and power training during the competitive season on physical fitness in high-level amateur football players. Sixteen male players (22.5 (SD 2.5) years, 1.79 (0.05) m, 76.8 (6.1) kg) from one team were randomly assigned to either a strength training (ST, N = 8) or a control (CON, N = 8) group. ST conducted lower extremity resistance exercises combined with plyometrics and/or sprints 2 × 30 min per week for 7 weeks. CON performed technical-tactical training during the same time period. Before and after training several physical fitness parameters were assessed: one-repetition maximum (1-RM, half squat), isometric peak strength and rate of force development (RFD, leg press), jump height (countermovement, CMJ, drop jump, DJ), sprint times, agility, and intermittent endurance. Large significant test × group interactions were found for 1-RM, CMJ, and DJ reactivity index with increases in CT relative to CON(+11 to 18%). Although not significant (P < 0.20), likely practically relevant effects were observed for isometric peak strength and RFD (+24 to 29%). We found no relevant interaction effects for agility, sprint times, and intermittent endurance. A 7-week in-season combined strength and power training program can improve relevant strength and jump parameters in high-level amateur football players.

  13. Application of modern tests for stationarity to single-trial MEG data: transferring powerful statistical tools from econometrics to neuroscience.

    PubMed

    Kipiński, Lech; König, Reinhard; Sielużycki, Cezary; Kordecki, Wojciech

    2011-10-01

    Stationarity is a crucial yet rarely questioned assumption in the analysis of time series of magneto- (MEG) or electroencephalography (EEG). One key drawback of the commonly used tests for stationarity of encephalographic time series is the fact that conclusions on stationarity are only indirectly inferred either from the Gaussianity (e.g. the Shapiro-Wilk test or Kolmogorov-Smirnov test) or the randomness of the time series and the absence of trend using very simple time-series models (e.g. the sign and trend tests by Bendat and Piersol). We present a novel approach to the analysis of the stationarity of MEG and EEG time series by applying modern statistical methods which were specifically developed in econometrics to verify the hypothesis that a time series is stationary. We report our findings of the application of three different tests of stationarity--the Kwiatkowski-Phillips-Schmidt-Schin (KPSS) test for trend or mean stationarity, the Phillips-Perron (PP) test for the presence of a unit root and the White test for homoscedasticity--on an illustrative set of MEG data. For five stimulation sessions, we found already for short epochs of duration of 250 and 500 ms that, although the majority of the studied epochs of single MEG trials were usually mean-stationary (KPSS test and PP test), they were classified as nonstationary due to their heteroscedasticity (White test). We also observed that the presence of external auditory stimulation did not significantly affect the findings regarding the stationarity of the data. We conclude that the combination of these tests allows a refined analysis of the stationarity of MEG and EEG time series.

  14. The effect of heterogeneous variance on efficiency and power of cluster randomized trials with a balanced 2 × 2 factorial design.

    PubMed

    Lemme, Francesca; van Breukelen, Gerard J P; Candel, Math J J M; Berger, Martijn P F

    2015-10-01

    Sample size calculation for cluster randomized trials (CRTs) with a [Formula: see text] factorial design is complicated due to the combination of nesting (of individuals within clusters) with crossing (of two treatments). Typically, clusters and individuals are allocated across treatment conditions in a balanced fashion, which is optimal under homogeneity of variance. However, the variance is likely to be heterogeneous if there is a treatment effect. An unbalanced allocation is then more efficient, but impractical because the optimal allocation depends on the unknown variances. Focusing on CRTs with a [Formula: see text] design, this paper addresses two questions: How much efficiency is lost by having a balanced design when the outcome variance is heterogeneous? How large must the sample size be for a balanced allocation to have sufficient power under heterogeneity of variance? We consider different scenarios of heterogeneous variance. Within each scenario, we determine the relative efficiency of a balanced design, as a function of the level (cluster, individual, both) and amount of heterogeneity of the variance. We then provide a simple correction of the sample size for the loss of power due to heterogeneity of variance when a balanced allocation is used. The theory is illustrated with an example of a published 2 x2 CRT.

  15. Zinc content of selected tissues and taste perception in rats fed zinc deficient and zinc adequate rations

    SciTech Connect

    Boeckner, L.S.; Kies, C.

    1986-03-05

    The objective of the study was to determine the effects of feeding zinc sufficient and zinc deficient rations on taste sensitivity and zinc contents of selected organs in rats. The 36 Sprague-Dawley male weanling rats were divided into 2 groups and fed zinc deficient or zinc adequate rations. The animals were subjected to 4 trial periods in which a choice of deionized distilled water or a solution of quinine sulfate at 1.28 x 10/sup -6/ was given. A randomized schedule for rat sacrifice was used. No differences were found between zinc deficient and zinc adequate rats in taste preference aversion scores for quinine sulfate in the first three trial periods; however, in the last trial period rats in the zinc sufficient group drank somewhat less water containing quinine sulfate as a percentage of total water consumption than did rats fed the zinc deficient ration. Significantly higher zinc contents of kidney, brain and parotid salivary glands were seen in zinc adequate rats compared to zinc deficient rats at the end of the study. However, liver and tongue zinc levels were lower for both groups at the close of the study than were those of rats sacrificed at the beginning of the study.

  16. Good enough: a primer on the analysis and interpretation of noninferiority trials.

    PubMed

    Kaul, Sanjay; Diamond, George A

    2006-07-04

    Active-control noninferiority trials are being performed with increasing frequency when standard placebo-controlled trials are considered unethical. Three attributes are optimally required to establish noninferiority: 1) The treatment under consideration exhibits therapeutic noninferiority to the active control; 2) the treatment would exhibit therapeutic efficacy in a placebo-controlled trial if such a trial were to be performed; and 3) the treatment offers ancillary advantages in safety, tolerability, cost, or convenience. Trials designed to show noninferiority require an appropriate reference population, a proven active control and dose, a high level of adherence to treatment, and adequate statistical power. However, the formal analysis of such trials is founded on several assumptions that cannot be validated explicitly. These assumptions are evaluated in the context of 8 recently published noninferiority trials. The analyses in this paper confirm the establishment of noninferiority in only 4 of the 8 trials. The authors conclude that if noninferiority trials are to be applied to clinical and regulatory decisions about the marketing and use of new treatments, these assumptions must be made explicit and their influence on the resultant conclusions assessed rigorously.

  17. Elements for adequate informed consent in the surgical context.

    PubMed

    Abaunza, Hernando; Romero, Klaus

    2014-07-01

    Given a history of atrocities and violations of ethical principles, several documents and regulations have been issued by a wide variety of organizations. They aim at ensuring that health care and clinical research adhere to defined ethical principles. A fundamental component was devised to ensure that the individual has been provided the necessary information to make an informed decision regarding health care or participation in clinical research. This article summarizes the history and regulations for informed consent and discusses suggested components for adequate consent forms for daily clinical practice in surgery as well as clinical research.

  18. Epidemiology and reporting of randomised trials published in PubMed journals.

    PubMed

    Chan, An-Wen; Altman, Douglas G

    Although randomised trials are important for evidence-based medicine, little is known about their overall characteristics. We assessed the epidemiology and reporting of methodological details for all 519 PubMed-indexed randomised trials published in December, 2000 (383 [74%] parallel-group, 116 [22%] crossover). 482 (93%) were published in specialty journals. A median of 80 participants (10th-90th percentile 25-369) were recruited for parallel-group trials. 309 (60%) were blinded. Power calculation, primary outcomes, random sequence generation, allocation concealment, and handling of attrition were each adequately described in less than half of publications. The small sample sizes are worrying, and poor reporting of methodological characteristics will prevent reliable quality assessment of many published trials.

  19. Quantifying dose to the reconstructed breast: Can we adequately treat?

    SciTech Connect

    Chung, Eugene; Marsh, Robin B.; Griffith, Kent A.; Moran, Jean M.; Pierce, Lori J.

    2013-04-01

    To evaluate how immediate reconstruction (IR) impacts postmastectomy radiotherapy (PMRT) dose distributions to the reconstructed breast (RB), internal mammary nodes (IMN), heart, and lungs using quantifiable dosimetric end points. 3D conformal plans were developed for 20 IR patients, 10 autologous reconstruction (AR), and 10 expander-implant (EI) reconstruction. For each reconstruction type, 5 right- and 5 left-sided reconstructions were selected. Two plans were created for each patient, 1 with RB coverage alone and 1 with RB + IMN coverage. Left-sided EI plans without IMN coverage had higher heart Dmean than left-sided AR plans (2.97 and 0.84 Gy, p = 0.03). Otherwise, results did not vary by reconstruction type and all remaining metrics were evaluated using a combined AR and EI dataset. RB coverage was adequate regardless of laterality or IMN coverage (Dmean 50.61 Gy, D95 45.76 Gy). When included, IMN Dmean and D95 were 49.57 and 40.96 Gy, respectively. Mean heart doses increased with left-sided treatment plans and IMN inclusion. Right-sided treatment plans and IMN inclusion increased mean lung V{sub 20}. Using standard field arrangements and 3D planning, we observed excellent coverage of the RB and IMN, regardless of laterality or reconstruction type. Our results demonstrate that adequate doses can be delivered to the RB with or without IMN coverage.

  20. When one is not enough: prevalence and characteristics of homes not adequately protected by smoke alarms

    PubMed Central

    Peek-Asa, C; Allareddy, V; Yang, J; Taylor, C; Lundell, J; Zwerling, C

    2005-01-01

    Objective: The National Fire Protection Association (NFPA) has specific recommendations about the number, location, and type of smoke alarms that are needed to provide maximum protection for a household. No previous studies have examined whether or not homes are completely protected according to these guidelines. The authors describe the prevalence and home characteristics associated with compliance to recommendations for smoke alarm installation by the NFPA. Design, setting, and subjects: Data are from the baseline on-site survey of a randomized trial to measure smoke alarm effectiveness. The trial was housed in a longitudinal cohort study in a rural Iowa county. Of 1005 homes invited, 691 (68.8%) participated. Main outcome measures: Information about smoke alarm type, placement, and function, as well as home and occupant characteristics, was collected through an on-site household survey. Results: Although 86.0% of homes had at least one smoke alarm, only 22.3% of homes (approximately one in five) were adequately protected according to NFPA guidelines. Fourteen percent of homes had no functioning smoke alarms. More than half of the homes with smoke alarms did not have enough of them or had installed them incorrectly, and 42.4% of homes with alarms had at least one alarm that did not operate. Homes with at least one high school graduate were nearly four times more likely to be fully protected. Homes that had multiple levels, a basement, or were cluttered or poorly cleaned were significantly less likely to be fully protected. Conclusion: These findings indicate that consumers may not be knowledgeable about the number of alarms they need or how to properly install them. Occupants are also not adequately maintaining the alarms that are installed. PMID:16326772

  1. Reporting of Positive Results in Randomized Controlled Trials of Mindfulness-Based Mental Health Interventions

    PubMed Central

    Coronado-Montoya, Stephanie; Levis, Alexander W.; Kwakkenbos, Linda; Steele, Russell J.; Turner, Erick H.; Thombs, Brett D.

    2016-01-01

    Background A large proportion of mindfulness-based therapy trials report statistically significant results, even in the context of very low statistical power. The objective of the present study was to characterize the reporting of “positive” results in randomized controlled trials of mindfulness-based therapy. We also assessed mindfulness-based therapy trial registrations for indications of possible reporting bias and reviewed recent systematic reviews and meta-analyses to determine whether reporting biases were identified. Methods CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS databases were searched for randomized controlled trials of mindfulness-based therapy. The number of positive trials was described and compared to the number that might be expected if mindfulness-based therapy were similarly effective compared to individual therapy for depression. Trial registries were searched for mindfulness-based therapy registrations. CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS were also searched for mindfulness-based therapy systematic reviews and meta-analyses. Results 108 (87%) of 124 published trials reported ≥1 positive outcome in the abstract, and 109 (88%) concluded that mindfulness-based therapy was effective, 1.6 times greater than the expected number of positive trials based on effect size d = 0.55 (expected number positive trials = 65.7). Of 21 trial registrations, 13 (62%) remained unpublished 30 months post-trial completion. No trial registrations adequately specified a single primary outcome measure with time of assessment. None of 36 systematic reviews and meta-analyses concluded that effect estimates were overestimated due to reporting biases. Conclusions The proportion of mindfulness-based therapy trials with statistically significant results may overstate what would occur in practice. PMID:27058355

  2. Prostate cancer between prognosis and adequate/proper therapy

    PubMed Central

    Grozescu, T; Popa, F

    2017-01-01

    Knowing the indolent, non-invasive nature of most types of prostate cancer, as well as the simple fact that the disease seems more likely to be associated with age rather than with other factors (50% of men at the age of 50 and 80% at the age of 80 have it [1], with or without presenting any symptom), the big challenge of this clinical entity was to determine severity indicators (so far insufficient) to guide the physician towards an adequate attitude in the clinical setting. The risk of over-diagnosing and over-treating many prostate cancer cases (indicated by all the major European and American studies) is real and poses many question marks. The present paper was meant to deliver new research data and to reset the clinical approach in prostate cancer cases. PMID:28255369

  3. The cerebellopontine angle: does the translabyrinthine approach give adequate access?

    PubMed

    Fagan, P A; Sheehy, J P; Chang, P; Doust, B D; Coakley, D; Atlas, M D

    1998-05-01

    A long-standing but unfounded criticism of the translabyrinthine approach is the misperception that this approach does not give adequate access to the cerebellopontine angle. Because of what is perceived as limited visualization and operating space within the cerebellopontine angle, some surgeons still believe that the translabyrinthine approach is inappropriate for large acoustic tumors. In this study, the surgical access to the cerebellopontine angle by virtue of the translabyrinthine approach is measured and analyzed. The parameters are compared with those measured for the retrosigmoid approach. This series objectively confirms that the translabyrinthine approach offers the neurotologic surgeon a shorter operative depth to the tumor, via a similar-sized craniotomy. This permits superior visualization by virtue of a wider angle of surgical access. Such access is achieved with the merit of minimal cerebellar retraction.

  4. Barriers to adequate prenatal care utilization in American Samoa

    PubMed Central

    Hawley, Nicola L; Brown, Carolyn; Nu’usolia, Ofeira; Ah-Ching, John; Muasau-Howard, Bethel; McGarvey, Stephen T

    2013-01-01

    Objective To describe the utilization of prenatal care in American Samoan women and to identify socio-demographic predictors of inadequate prenatal care utilization. Methods Using data from prenatal clinic records, women (n=692) were categorized according to the Adequacy of Prenatal Care Utilization Index as having received adequate plus, adequate, intermediate or inadequate prenatal care during their pregnancy. Categorical socio-demographic predictors of the timing of initiation of prenatal care (week of gestation) and the adequacy of received services were identified using one way Analysis of Variance (ANOVA) and independent samples t-tests. Results Between 2001 and 2008 85.4% of women received inadequate prenatal care. Parity (P=0.02), maternal unemployment (P=0.03), and both parents being unemployed (P=0.03) were negatively associated with the timing of prenatal care initation. Giving birth in 2007–2008, after a prenatal care incentive scheme had been introduced in the major hospital, was associated with earlier initiation of prenatal care (20.75 versus 25.12 weeks; P<0.01) and improved adequacy of received services (95.04% versus 83.8%; P=0.02). Conclusion The poor prenatal care utilization in American Samoa is a major concern. Improving healthcare accessibility will be key in encouraging women to attend prenatal care. The significant improvements in the adequacy of prenatal care seen in 2007–2008 suggest that the prenatal care incentive program implemented in 2006 may be a very positive step toward addressing issues of prenatal care utilization in this population. PMID:24045912

  5. Clinical Trials

    MedlinePlus

    ... Sponsors Why Are They Important How Do They Work Who Can Participate What To Expect During Benefits and Risks How They Protect Participants Finding Clinical Trials Links Children & Clinical Studies NHLBI Trials Clinical Trial Websites What Are Clinical ...

  6. Adequate Yearly Progress (AYP) at Your Library Media Center

    ERIC Educational Resources Information Center

    Anderson, Cynthia

    2007-01-01

    Together administration and the library media center form a team that can make a difference in student learning and, in turn, in student achievement. The library media center can contribute to improve student learning, and there is an amazingly small cost that administration must pay for this powerful support. This article addresses…

  7. Systemic Crisis of Civilization: In Search for Adequate Solution

    NASA Astrophysics Data System (ADS)

    Khozin, Grigori

    In December 1972 a jumbo jet crashed in the Florida Everglades with the loss of 101 lives. The pilot, distracted by a minor malfunction, failed to note until too late the warning signal that - correctly - indicated an impending disaster. His sudden, astonished cry of Hey, what happening here? were his last words 1. Three decades after this tragic episode, as the Humankind approaches the threshold of the third Millennium, the problem of adequate reaction to warning signals of different nature and of distinguishing minor malfunctions in everyday life of society, in economy and technology as well as in evolution of biosphere from grave threats to the world community and the phenomenon of life on our planet remains crucial to human survival and the future of Civilization. Rational use of knowledge and technology available to the world community remains in this context the corner stone of discussions on the destiny of the intelligent life both on the planet Earth and in the Universe (the fact of intelligent life in the Universe is to be detected by the Humankind)…

  8. ENSURING ADEQUATE SAFETY WHEN USING HYDROGEN AS A FUEL

    SciTech Connect

    Coutts, D

    2007-01-22

    Demonstration projects using hydrogen as a fuel are becoming very common. Often these projects rely on project-specific risk evaluations to support project safety decisions. This is necessary because regulations, codes, and standards (hereafter referred to as standards) are just being developed. This paper will review some of the approaches being used in these evolving standards, and techniques which demonstration projects can implement to bridge the gap between current requirements and stakeholder desires. Many of the evolving standards for hydrogen-fuel use performance-based language, which establishes minimum performance and safety objectives, as compared with prescriptive-based language that prescribes specific design solutions. This is being done for several reasons including: (1) concern that establishing specific design solutions too early will stifle invention, (2) sparse performance data necessary to support selection of design approaches, and (3) a risk-adverse public which is unwilling to accept losses that were incurred in developing previous prescriptive design standards. The evolving standards often contain words such as: ''The manufacturer shall implement the measures and provide the information necessary to minimize the risk of endangering a person's safety or health''. This typically implies that the manufacturer or project manager must produce and document an acceptable level of risk. If accomplished using comprehensive and systematic process the demonstration project risk assessment can ease the transition to widespread commercialization. An approach to adequately evaluate and document the safety risk will be presented.

  9. DARHT -- an adequate EIS: A NEPA case study

    SciTech Connect

    Webb, M.D.

    1997-08-01

    In April 1996 the US District Court in Albuquerque ruled that the Dual Axis Radiographic Hydrodynamic Test (DARHT) Facility Environmental Impact Statement (EIS), prepared by the Los Alamos Area Office, US Department of Energy (DOE), was adequate. The DARHT EIS had been prepared in the face of a lawsuit in only 10 months, a third of the time usually allotted for a DOE EIS, and for only a small fraction of the cost of a typical DOE EIS, and for only a small fraction of the cost of a typical DOE EIS. It subject was the first major facility to be built in decades for the DOE nuclear weapons stockpile stewardship program. It was the first EIS to be prepared for a proposal at DOE`s Los Alamos National Laboratory since 1979, and the first ever prepared by the Los Alamos Area Office. Much of the subject matter was classified. The facility had been specially designed to minimize impacts to a nearby prehistoric Native American ruin, and extensive consultation with American Indian Pueblos was required. The week that the draft EIS was published Laboratory biologists identified a previously unknown pair of Mexican spotted owls in the immediate vicinity of the project, bringing into play the consultation requirements of the Endangered Species Act. In spite of these obstacles, the resultant DARHT EIS was reviewed by the court and found to meet all statutory and regulatory requirements; the court praised the treatment of the classified material which served as a basis for the environmental analysis.

  10. Dose Limits for Man do not Adequately Protect the Ecosystem

    SciTech Connect

    Higley, Kathryn A.; Alexakhin, Rudolf M.; McDonald, Joseph C.

    2004-08-01

    It has been known for quite some time that different organisms display differing degrees of sensitivity to the effects of ionizing radiations. Some microorganisms such as the bacterium Micrococcus radiodurans, along with many species of invertebrates, are extremely radio-resistant. Humans might be categorized as being relatively sensitive to radiation, and are a bit more resistant than some pine trees. Therefore, it could be argued that maintaining the dose limits necessary to protect humans will also result in the protection of most other species of flora and fauna. This concept is usually referred to as the anthropocentric approach. In other words, if man is protected then the environment is also adequately protected. The ecocentric approach might be stated as; the health of humans is effectively protected only when the environment is not unduly exposed to radiation. The ICRP is working on new recommendations dealing with the protection of the environment, and this debate should help to highlight a number of relevant issues concerning that topic.

  11. Secondary analysis of clinical trials--a cautionary note.

    PubMed

    Marler, John R

    2012-01-01

    There is concern in published reports and reviews that patients are being harmed or denied effective treatment by the use of questionable results from secondary analyses of data from clinical trials. A well-reported secondary analysis must make clear to the reader the uncertainty of the result--so clear, in fact, that it should be an obvious part of the conclusions that implementation should await confirmation as the primary outcome in an adequately powered trial. Those who write, review and publish these reports have a responsibility to ensure that reports accurately describe the sources of uncertainty, explain complex methods and their weaknesses with clarity, and convince readers to require better evidence before changing their practice.

  12. Addition of prednisolone and heparin in patients with failed IVF/ICSI cycles: a preliminary report of a clinical trial.

    PubMed

    Siristatidis, Charalampos; Chrelias, Charalampos; Creatsa, Maria; Varounis, Christos; Vrachnis, Nikos; Iliodromiti, Zoe; Kassanos, Demetrios

    2013-09-01

    Through a non-randomized clinical trial, we examined the theoretical benefit of the coadministration of low molecular weight heparin (LMWH) and prednisolone on pregnancy outcomes in women with previously failed IVF/ICSI cycles. Fifteen women constituted the study group, and were compared with 19 women receiving LMWH alone and another 18 women with no drugs. Our finding that the combination of the two drugs produced positive differences in terms of embryo quality, pregnancy and live birth rates points to the necessity for adequately powered randomized trials.

  13. On Adequate Comparisons of Antenna Phase Center Variations

    NASA Astrophysics Data System (ADS)

    Schoen, S.; Kersten, T.

    2013-12-01

    One important part for ensuring the high quality of the International GNSS Service's (IGS) products is the collection and publication of receiver - and satellite antenna phase center variations (PCV). The PCV are crucial for global and regional networks, since they introduce a global scale factor of up to 16ppb or changes in the height component with an amount of up to 10cm, respectively. Furthermore, antenna phase center variations are also important for precise orbit determination, navigation and positioning of mobile platforms, like e.g. the GOCE and GRACE gravity missions, or for the accurate Precise Point Positioning (PPP) processing. Using the EUREF Permanent Network (EPN), Baire et al. (2012) showed that individual PCV values have a significant impact on the geodetic positioning. The statements are further supported by studies of Steigenberger et al. (2013) where the impact of PCV for local-ties are analysed. Currently, there are five calibration institutions including the Institut für Erdmessung (IfE) contributing to the IGS PCV file. Different approaches like field calibrations and anechoic chamber measurements are in use. Additionally, the computation and parameterization of the PCV are completely different within the methods. Therefore, every new approach has to pass a benchmark test in order to ensure that variations of PCV values of an identical antenna obtained from different methods are as consistent as possible. Since the number of approaches to obtain these PCV values rises with the number of calibration institutions, there is the necessity for an adequate comparison concept, taking into account not only the numerical values but also stochastic information and computational issues of the determined PCVs. This is of special importance, since the majority of calibrated receiver antennas published by the IGS origin from absolute field calibrations based on the Hannover Concept, Wübbena et al. (2000). In this contribution, a concept for the adequate

  14. Are Vancomycin Trough Concentrations Adequate for Optimal Dosing?

    PubMed Central

    Youn, Gilmer; Jones, Brenda; Jelliffe, Roger W.; Drusano, George L.; Rodvold, Keith A.; Lodise, Thomas P.

    2014-01-01

    The current vancomycin therapeutic guidelines recommend the use of only trough concentrations to manage the dosing of adults with Staphylococcus aureus infections. Both vancomycin efficacy and toxicity are likely to be related to the area under the plasma concentration-time curve (AUC). We assembled richly sampled vancomycin pharmacokinetic data from three studies comprising 47 adults with various levels of renal function. With Pmetrics, the nonparametric population modeling package for R, we compared AUCs estimated from models derived from trough-only and peak-trough depleted versions of the full data set and characterized the relationship between the vancomycin trough concentration and AUC. The trough-only and peak-trough depleted data sets underestimated the true AUCs compared to the full model by a mean (95% confidence interval) of 23% (11 to 33%; P = 0.0001) and 14% (7 to 19%; P < 0.0001), respectively. In contrast, using the full model as a Bayesian prior with trough-only data allowed 97% (93 to 102%; P = 0.23) accurate AUC estimation. On the basis of 5,000 profiles simulated from the full model, among adults with normal renal function and a therapeutic AUC of ≥400 mg · h/liter for an organism for which the vancomycin MIC is 1 mg/liter, approximately 60% are expected to have a trough concentration below the suggested minimum target of 15 mg/liter for serious infections, which could result in needlessly increased doses and a risk of toxicity. Our data indicate that adjustment of vancomycin doses on the basis of trough concentrations without a Bayesian tool results in poor achievement of maximally safe and effective drug exposures in plasma and that many adults can have an adequate vancomycin AUC with a trough concentration of <15 mg/liter. PMID:24165176

  15. Is clinical measurement of anatomic axis of the femur adequate?

    PubMed

    Wu, Chi-Chuan

    2017-03-23

    Background and purpose - The accuracy of using clinical measurement from the anterior superior iliac spine (ASIS) to the center of the knee to determine an anatomic axis of the femur has rarely been studied. A radiographic technique with a full-length standing scanogram (FLSS) was used to assess the adequacy of the clinical measurement. Patients and methods - 100 consecutive young adult patients (mean age 34 (20-40) years) with chronic unilateral lower extremity injuries were studied. The pelvis and intact contralateral lower extremity images in the FLSS were selected for study. The angles between the tibial axis and the femoral shaft anatomic axis (S-AA), the piriformis anatomic axis (P-AA), the clinical anatomic axis (C-AA), and the mechanical axis (MA) were compared between sexes. Results - Only the S-AA and C-AA angles were statistically significantly different in the 100 patients (3.6° vs. 2.8°; p = 0.03). There was a strong correlation between S-AA, P-AA, and C-AA angles (r > 0.9). The average intersecting angle between MA and S-AA in the femur in the 100 patients was 5.5°, and it was 4.8° between MA and C-AA. Interpretation - Clinical measurement of an anatomic axis from the ASIS to the center of the knee may be an adequate and acceptable method to determine lower extremity alignment. The optimal inlet for antegrade femoral intramedullary nailing may be the lateral edge of the piriformis fossa.

  16. Critical power derived from a 3-min all-out test predicts 16.1-km road time-trial performance.

    PubMed

    Black, Matthew I; Durant, Jacob; Jones, Andrew M; Vanhatalo, Anni

    2014-01-01

    It has been shown that the critical power (CP) in cycling estimated using a novel 3-min all-out protocol is reliable and closely matches the CP derived from conventional procedures. The purpose of this study was to assess the predictive validity of the all-out test CP estimate. We hypothesised that the all-out test CP would be significantly correlated with 16.1-km road time-trial (TT) performance and more strongly correlated with performance than the gas exchange threshold (GET), respiratory compensation point (RCP) and VO2 max. Ten club-level male cyclists (mean±SD: age 33.8±8.2 y, body mass 73.8±4.3 kg, VO2 max 60±4 ml·kg(-1)·min(-1)) performed a 10-mile road TT, a ramp incremental test to exhaustion, and two 3-min all-out tests, the first of which served as familiarisation. The 16.1-km TT performance (27.1±1.2 min) was significantly correlated with the CP (309±34 W; r = -0.83, P<0.01) and total work done during the all-out test (70.9±6.5 kJ; r = -0.86, P<0.01), the ramp incremental test peak power (433±30 W; r = -0.75, P<0.05) and the RCP (315±29 W; r = -0.68, P<0.05), but not with GET (151±32 W; r = -0.21) or the VO2 max (4.41±0.25 L·min(-1); r = -0.60). These data provide evidence for the predictive validity and practical performance relevance of the 3-min all-out test. The 3-min all-out test CP may represent a useful addition to the battery of tests employed by applied sport physiologists or coaches to track fitness and predict performance in atheletes.

  17. Study Design and Rationale for the Phase 3 Clinical Development Program of Enobosarm, a Selective Androgen Receptor Modulator, for the Prevention and Treatment of Muscle Wasting in Cancer Patients (POWER Trials).

    PubMed

    Crawford, Jeffrey; Prado, Carla M M; Johnston, Mary Ann; Gralla, Richard J; Taylor, Ryan P; Hancock, Michael L; Dalton, James T

    2016-06-01

    Muscle wasting in cancer is a common and often occult condition that can occur prior to overt signs of weight loss and before a clinical diagnosis of cachexia can be made. Muscle wasting in cancer is an important and independent predictor of progressive functional impairment, decreased quality of life, and increased mortality. Although several therapeutic agents are currently in development for the treatment of muscle wasting or cachexia in cancer, the majority of these agents do not directly inhibit muscle loss. Selective androgen receptor modulators (SARMs) have the potential to increase lean body mass (LBM) and hence muscle mass, without the untoward side effects seen with traditional anabolic agents. Enobosarm, a nonsteroidal SARM, is an agent in clinical development for prevention and treatment of muscle wasting in patients with cancer (POWER 1 and 2 trials). The POWER trials are two identically designed randomized, double-blind, placebo-controlled, multicenter, and multinational phase 3 trials to assess the efficacy of enobosarm for the prevention and treatment of muscle wasting in subjects initiating first-line chemotherapy for non-small-cell lung cancer (NSCLC). To assess enobosarm's effect on both prevention and treatment of muscle wasting, no minimum weight loss is required. These pivotal trials have pioneered the methodological and regulatory fields exploring a therapeutic agent for cancer-associated muscle wasting, a process hereby described. In each POWER trial, subjects will receive placebo (n = 150) or enobosarm 3 mg (n = 150) orally once daily for 147 days. Physical function, assessed as stair climb power (SCP), and LBM, assessed by dual-energy X-ray absorptiometry (DXA), are the co-primary efficacy endpoints in both trials assessed at day 84. Based on extensive feedback from the US Food and Drug Administration (FDA), the co-primary endpoints will be analyzed as a responder analysis. To be considered a physical function responder, a

  18. Making sense of noninferiority: a clinical and statistical perspective on its application to cardiovascular clinical trials.

    PubMed

    Kaul, Sanjay; Diamond, George A

    2007-01-01

    Active control noninferiority trials are being used with increasing frequency in new drug or device development when standard placebo-controlled trials are considered unethical. Nevertheless, the design and analysis of these trials are founded on a number of assumptions and arbitrary criteria that are generally not well understood or justifiable. Trials designed to show noninferiority require an appropriate reference population, a proven active control and dose, an appropriate margin of noninferiority that is clinically relevant and statistically justifiable, a high level of adherence to treatment, and adequate statistical power to reliably conclude that a treatment is truly noninferior and therefore effective. Accordingly, if noninferiority trials are to be applied to clinical and regulatory decisions regarding the marketing and use of new treatments, the assumptions must be made explicit and their influence on the resultant conclusions must be assessed rigorously. When conservative criteria were applied to each of the key assumptions underlying 2 representative noninferiority trials, they materially undermined the conclusions regarding noninferiority failing to confirm reported conclusions regarding noninferiority despite enthusiastic dissemination and acceptance of the results. Because the clinical, regulatory, and economic impact of active control noninferiority trials is substantial, robust criteria should be used routinely in their design, analysis, and interpretation to reach their intended objectives and to keep them from becoming wasted efforts.

  19. Randomised controlled trial and economic analysis of an internet-based weight management programme: POWeR+ (Positive Online Weight Reduction).

    PubMed Central

    Little, Paul; Stuart, Beth; Hobbs, Fd Richard; Kelly, Jo; Smith, Emily R; Bradbury, Katherine J; Hughes, Stephanie; Smith, Peter Wf; Moore, Michael V; Lean, Mike Ej; Margetts, Barrie M; Byrne, Christopher D; Griffin, Simon; Davoudianfar, Mina; Hooper, Julie; Yao, Guiqing; Zhu, Shihua; Raftery, James; Yardley, Lucy

    2017-01-01

    BACKGROUND Behavioural counselling with intensive follow-up for obesity is effective, but in resource-constrained primary care settings briefer approaches are needed. OBJECTIVES To estimate the clinical effectiveness and cost-effectiveness of an internet-based behavioural intervention with regular face-to-face or remote support in primary care, compared with brief advice. DESIGN Individually randomised three-arm parallel trial with health economic evaluation and nested qualitative interviews. SETTING Primary care general practices in the UK. PARTICIPANTS Patients with a body mass index of ≥ 30 kg/m(2) (or ≥ 28 kg/m(2) with risk factors) identified from general practice records, recruited by postal invitation. INTERVENTIONS Positive Online Weight Reduction (POWeR+) is a 24-session, web-based weight management intervention completed over 6 months. Following online registration, the website randomly allocated participants using computer-generated random numbers to (1) the control intervention (n = 279), which had previously been demonstrated to be clinically effective (brief web-based information that minimised pressure to cut down foods, instead encouraging swaps to healthier choices and increasing fruit and vegetables, plus 6-monthly nurse weighing); (2) POWeR+F (n = 269), POWeR+ supplemented by face-to-face nurse support (up to seven contacts); or (3) POWeR+R (n = 270), POWeR+ supplemented by remote nurse support (up to five e-mails or brief telephone calls). MAIN OUTCOME MEASURES The primary outcome was a modelled estimate of average weight reduction over 12 months, assessed blind to group where possible, using multiple imputation for missing data. The secondary outcome was the number of participants maintaining a 5% weight reduction at 12 months. RESULTS A total of 818 eligible individuals were randomised using computer-generated random numbers. Weight change, averaged over 12 months, was documented in 666 out of 818 participants (81

  20. Using Vascular Quality Initiative as a Platform for Organizing Multicenter, Prospective, Randomized Clinical Trials: OVERPAR Trial

    PubMed Central

    Eslami, Mohammad H.; Doros, Gheorghe; Goodney, Philip P.; Elderup-Jorgenson, Jens; Cronenwett, Jack L.; Malikova, Marina; Farber, Alik

    2014-01-01

    Background We describe the organization of a prospective, randomized, multicenter trial comparing the effectiveness of open popliteal artery aneurysm repair (OPAR) and endovascular popliteal artery aneurysm repair (EPAR) of asymptomatic popliteal artery aneurysms (PAAs) as an example for how to use the Vascular Quality Initiative (VQI) framework. Given that many centers participate in the VQI, this model can be used to perform multicenters’ prospective trials on very modest budget. Methods VQI prospectively collects data on many vascular procedures. These data include many important perioperative, intraoperative, and postoperative details regarding both patients and their procedures. We describe a study where minimal changes to the collected data by participating centers can provide level-1 evidence regarding a significant clinical question. Data will be collected using modified VQI forms within the existing VQI data reporting structure. We plan to enroll 148 patients with asymptomatic PAAs into the open and endovascular surgery cohorts. Patients from participating VQI centers will be randomized 1:1 to either OPAR or EPAR and will be followed for an average of 2.5 years. Our primary hypothesis is that major adverse limb event–free survival is lower in the EPAR cohort and that EPAR is associated with more secondary interventions, improved quality of life, and decreased length of stay. The budget for this trial is fixed at $10,000/year for the course of the study, and the trial is judged to be feasible because of the functionality of the VQI platform. Conclusions Using the existing VQI infrastructure, Open versus Endovascular Repair of Popliteal Artery Aneurysm will provide level 1 data for PAA treatment on a modest budget. The proposed trial has an adequately powered comparative design that will use objective performance goals to describe limb-related morbidity and procedural reintervention rates. PMID:25311746

  1. Review of methodological issues of clinical trials in multiple sclerosis.

    PubMed

    Montalban, Xavier

    2011-12-01

    Phase III trials, with standardised definitions for short-term clinical and radiological outcome measures. The elaboration and implementation of this methodology were possible through international collaborations, and this has enabled extensive experience to be gained throughout the world. These trials have laid the foundation for an evidence-based medicine approach to the treatment of multiple sclerosis. Clinical trials in multiple sclerosis have to some extent become a victim of their own success, with more and more trials competing for a limited pool of patients and limited resources. Modern trials require large number of patients to generate adequate statistical power and this in turn entails recruitment in many countries across different continents. This increases the complexity and cost of the study, and contract research organisations now play a dominant role in the logistics and administration of these trials. The challenge in conducting trials on a global basis involving large numbers of countries is to ensure that this heterogeneity does not impinge on the reliability of the findings. This may happen due to differences in the patient populations included in different countries, access to or experience with methods in evaluation, for example certain magnetic resonance imaging (MRI) protocols, and also due to ethical considerations. In addition, whether disease-modifying treatments are reimbursed in a given country or not will influence what sort of patients are likely to get included in clinical trial protocols.

  2. Adequate nutrient intake can reduce cardiovascular disease risk in African Americans.

    PubMed

    Reusser, Molly E; DiRienzo, Douglas B; Miller, Gregory D; McCarron, David A

    2003-03-01

    Cardiovascular disease kills nearly as many Americans each year as the next seven leading causes of death combined. The prevalence of cardiovascular disease and most of its associated risk factors is markedly higher and increasing more rapidly among African Americans than in any other racial or ethnic group. Improving these statistics may be simply a matter of improving diet quality. In recent years, a substantial and growing body of evidence has revealed that dietary patterns complete in all food groups, including nutrient-rich dairy products, are essential for preventing and reducing cardiovascular disease and the conditions that contribute to it. Several cardiovascular risk factors, including hypertension, insulin resistance syndrome, and obesity, have been shown to be positively influenced by dietary patterns that include adequate intake of dairy products. The benefits of nutrient-rich dietary patterns have been specifically tested in randomized, controlled trials emphasizing African American populations. These studies demonstrated proportionally greater benefits for African Americans without evidence of adverse effects such as symptoms of lactose intolerance. As currently promoted for the prevention of certain cancers and osteoporosis, regular consumption of diets that meet recommended nutrient intake levels might also be the most effective approach for reducing cardiovascular disease risk in African Americans.

  3. Sildenafil does not improve steady state cardiovascular hemodynamics, peak power, or 15-km time trial cycling performance at simulated moderate or high altitudes in men and women.

    PubMed

    Kressler, Jochen; Stoutenberg, Mark; Roos, Bernard A; Friedlander, Anne L; Perry, Arlette C; Signorile, Joseph F; Jacobs, Kevin A

    2011-12-01

    Sildenafil improves oxygen delivery and maximal exercise capacity at very high altitudes (≥ 4,350 m), but it is unknown whether sildenafil improves these variables and longer-duration exercise performance at moderate and high altitudes where competitions are more common. The purpose of this study was to determine the effects of sildenafil on cardiovascular hemodynamics, arterial oxygen saturation (SaO(2)), peak exercise capacity (W (peak)), and 15-km time trial performance in endurance-trained subjects at simulated moderate (MA; ~2,100 m, 16.2% F(I)O(2)) and high (HA; ~3,900 m, 12.8% F(I)O(2)) altitudes. Eleven men and ten women completed two HA W (peak) trials after ingesting placebo or 50 mg sildenafil. Subjects then completed four exercise trials (30 min at 55% of altitude-specific W (peak) + 15-km time trial) at MA and HA after ingesting placebo or 50 mg sildenafil. All trials were performed in randomized, counterbalanced, and double-blind fashion. Sildenafil had little influence on cardiovascular hemodynamics at MA or HA, but did result in higher SaO(2) values (+3%, p < 0.05) compared to placebo during steady state and time trial exercise at HA. W (peak) at HA was 19% lower than SL (p < 0.001) and was not significantly affected by sildenafil. Similarly, the significantly slower time trial performance at MA (28.1 ± 0.5 min, p = 0.016) and HA (30.3 ± 0.6 min, p < 0.001) compared to SL (27.5 ± 0.6 min) was unaffected by sildenafil. We conclude that sildenafil is unlikely to exert beneficial effects at altitudes <4,000 m for a majority of the population.

  4. Methods for selection of adequate neural network structures with application to early assessment of chest pain patients by biochemical monitoring.

    PubMed

    Ellenius, J; Groth, T

    2000-07-01

    A methodology for selecting, training and estimating the performance of adequate artificial neural network (ANN) structures and incorporating them with algorithms that are optimized for clinical decision making is presented. The methodology was applied to the problem of early ruling-in/ruling-out of patients with suspected acute myocardial infarction using frequent biochemical monitoring. The selection of adequate ANN structures from a set of candidates was based on criteria for model compatibility, parameter identifiability and diagnostic performance. The candidate ANN structures evaluated were the single-layer perceptron (SLP), the fuzzified SLP, the multiple SLP, the gated multiple SLP, the multi-layer perceptron (MLP) and the discrete-time recursive neural network. The identifiability of the ANNs was assessed in terms of the conditioning of the Hessian of the objective function, and variability of parameter estimates and decision boundaries in the trials of leave-one-out cross-validation. The commonly used MLP was shown to be non-identifiable for the present problem and available amount of data, despite artificially reducing the model complexity with use of regularization methods. The investigation is concluded by recommending a number of guidelines in order to obtain an adequate ANN model.

  5. Evaluating Intermittent Androgen-Deprivation Therapy Phase III Clinical Trials: The Devil Is in the Details

    PubMed Central

    Tangen, Catherine; Higano, Celestia; Vogelzang, Nicholas; Thompson, Ian

    2016-01-01

    Purpose Intermittent androgen deprivation (IAD) has been widely tested in prostate cancer. However, phase III trials testing continuous androgen deprivation (CAD) versus IAD have reached inconclusive and seemingly contradictory results. Different design and conduct issues must be critically evaluated to better interpret the results. Patients and Methods Seven published phase III trials were examined for prespecified design and outcomes. Treatment specifications; primary end point; superiority versus noninferiority design assumptions, including magnitude of assumed versus observed noninferiority margin (NIM); duration of follow-up; and quality-of-life (QOL) outcomes were considered in terms of the results and conclusions reported. Results Five trials had a superiority and three had a noninferiority primary hypothesis. Only three trials had a uniform population and overall survival (OS) end point. All trials observed better outcomes in terms of OS and progression-free survival (PFS) than assumed at time of study design, translating into prespecified NIMs or hazard ratios that reflected larger absolute differences in OS or PFS between arms. Lower-than-expected event rates also reduced statistical power for the trials. Other factors, including length of follow-up, cause of death, QOL, and primary end point, and their impact on trial interpretation are discussed. Conclusion No trial to date has demonstrated survival superiority of IAD compared with CAD. Trials concluding IAD is noninferior to CAD were based on wide NIMs that included clinically important survival differences, not likely to be considered comparable by physicians or patients. Interim analyses relying on short follow-up and including a majority of non–prostate cancer deaths will favor a noninferiority conclusion and should be interpreted cautiously. Adequate follow-up is required to ensure capture of prostate cancer deaths in both superiority and noninferiority trials. PMID:26552421

  6. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; adequate directions for use. 801... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for use. Adequate directions for use means directions under which the layman can use a device...

  7. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; adequate directions for use. 801... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for use. Adequate directions for use means directions under which the layman can use a device...

  8. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices; adequate directions for use. 801... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for use. Adequate directions for use means directions under which the layman can use a device...

  9. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical devices; adequate directions for use. 801... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for use. Adequate directions for use means directions under which the layman can use a device...

  10. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices; adequate directions for use. 801... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for use. Adequate directions for use means directions under which the layman can use a device...

  11. ICD-10 FIELD TRIALS IN INDIA - A REPORT

    PubMed Central

    Raghuram, R.; Shamasundar, C.

    1992-01-01

    The draft of the tenth revision of the International Classification Of Diseases, Chapter V (ICD-10) was subjected to extensive field trials throughout the world. In India, Nine Field Trial Centres (PTCs) conducted the field trials. The results showed that the ICD-10 was quite adequate in its face-validity, reliability, applicability and ease of use. A brief account of the field trials and the result are reported. PMID:21776123

  12. Initial Results of Instrument-Flying Trials Conducted In A Single-Rotor Helicopter

    NASA Technical Reports Server (NTRS)

    Crim, Almer D; Reeder, John P; Whitten, James B

    1953-01-01

    Instrument-flying trials have been conducted in a single-rotor helicopter, the maneuver stability of which could be changed from satisfactory to unsatisfactory. The results indicated that existing longitudinal flying-qualities requirements based on contact flight were adequate for instrument flight at speeds above that for minimum power. However, lateral-directional problems were encountered at low speeds and during precision maneuvers. The adequacy, for helicopter use, of standard airplane instruments was also investigated, and the conclusion was reached that special instruments would be desirable under all conditions, and necessary for sustained low-speed instrument flight.

  13. GOST: A generic ordinal sequential trial design for a treatment trial in an emerging pandemic

    PubMed Central

    Whitehead, John

    2017-01-01

    Background Conducting clinical trials to assess experimental treatments for potentially pandemic infectious diseases is challenging. Since many outbreaks of infectious diseases last only six to eight weeks, there is a need for trial designs that can be implemented rapidly in the face of uncertainty. Outbreaks are sudden and unpredictable and so it is essential that as much planning as possible takes place in advance. Statistical aspects of such trial designs should be evaluated and discussed in readiness for implementation. Methodology/Principal findings This paper proposes a generic ordinal sequential trial design (GOST) for a randomised clinical trial comparing an experimental treatment for an emerging infectious disease with standard care. The design is intended as an off-the-shelf, ready-to-use robust and flexible option. The primary endpoint is a categorisation of patient outcome according to an ordinal scale. A sequential approach is adopted, stopping as soon as it is clear that the experimental treatment has an advantage or that sufficient advantage is unlikely to be detected. The properties of the design are evaluated using large-sample theory and verified for moderate sized samples using simulation. The trial is powered to detect a generic clinically relevant difference: namely an odds ratio of 2 for better rather than worse outcomes. Total sample sizes (across both treatments) of between 150 and 300 patients prove to be adequate in many cases, but the precise value depends on both the magnitude of the treatment advantage and the nature of the ordinal scale. An advantage of the approach is that any erroneous assumptions made at the design stage about the proportion of patients falling into each outcome category have little effect on the error probabilities of the study, although they can lead to inaccurate forecasts of sample size. Conclusions/Significance It is important and feasible to pre-determine many of the statistical aspects of an efficient trial

  14. The Design of Cluster Randomized Crossover Trials

    ERIC Educational Resources Information Center

    Rietbergen, Charlotte; Moerbeek, Mirjam

    2011-01-01

    The inefficiency induced by between-cluster variation in cluster randomized (CR) trials can be reduced by implementing a crossover (CO) design. In a simple CO trial, each subject receives each treatment in random order. A powerful characteristic of this design is that each subject serves as its own control. In a CR CO trial, clusters of subjects…

  15. The Public Repository of Xenografts (ProXe) enables discovery and randomized phase II-like trials in mice

    PubMed Central

    Townsend, Elizabeth C.; Murakami, Mark A.; Christodoulou, Alexandra; Christie, Amanda L.; Köster, Johannes; DeSouza, Tiffany A.; Morgan, Elizabeth A.; Kallgren, Scott P.; Liu, Huiyun; Wu, Shuo-Chieh; Plana, Olivia; Montero, Joan; Stevenson, Kristen E.; Rao, Prakash; Vadhi, Raga; Andreeff, Michael; Armand, Philippe; Ballen, Karen K.; Barzaghi-Rinaudo, Patrizia; Cahill, Sarah; Clark, Rachael A.; Cooke, Vesselina G.; Davids, Matthew S.; DeAngelo, Daniel J.; Dorfman, David M.; Eaton, Hilary; Ebert, Benjamin L.; Etchin, Julia; Firestone, Brant; Fisher, David C.; Freedman, Arnold S.; Galinsky, Ilene A.; Gao, Hui; Garcia, Jacqueline S.; Garnache-Ottou, Francine; Graubert, Timothy A.; Gutierrez, Alejandro; Halilovic, Ensar; Harris, Marian H.; Herbert, Zachary T.; Horwitz, Steven M.; Inghirami, Giorgio; Intlekoffer, Andrew M.; Ito, Moriko; Izraeli, Shai; Jacobsen, Eric D.; Jacobson, Caron A.; Jeay, Sébastien; Jeremias, Irmela; Kelliher, Michelle A.; Koch, Raphael; Konopleva, Marina; Kopp, Nadja; Kornblau, Steven M.; Kung, Andrew L.; Kupper, Thomas S.; LaBoeuf, Nicole; LaCasce, Ann S.; Lees, Emma; Li, Loretta S.; Look, A. Thomas; Murakami, Masato; Muschen, Markus; Neuberg, Donna; Ng, Samuel Y.; Odejide, Oreofe O.; Orkin, Stuart H.; Paquette, Rachel R.; Place, Andrew E.; Roderick, Justine E.; Ryan, Jeremy A.; Sallan, Stephen E.; Shoji, Brent; Silverman, Lewis B.; Soiffer, Robert J.; Steensma, David P.; Stegmaier, Kimberly; Stone, Richard M.; Tamburini, Jerome; Thorner, Aaron R.; van Hummelen, Paul; Wadleigh, Martha; Wiesmann, Marion; Weng, Andrew P.; Wuerthner, Jens U.; Williams, David A.; Wollison, Bruce M.; Lane, Andrew A.; Letai, Anthony; Bertagnolli, Monica M.; Ritz, Jerome; Brown, Myles; Long, Henry; Aster, Jon C.; Shipp, Margaret A.; Griffin, James D.; Weinstock, David M.

    2016-01-01

    Summary Over 90% of drugs with preclinical activity fail in human trials, largely due to insufficient efficacy. We hypothesized that adequately powered trials of patient-derived xenografts (PDX) in mice could efficiently define therapeutic activity across heterogeneous tumors. To address this hypothesis, we established a large, publically available repository of well-characterized leukemia and lymphoma PDXs that undergo orthotopic engraftment called the Public Repository of Xenografts (PRoXe; www.proxe.org). PRoXe includes all de-identified information relevant to the primary specimens and the PDXs derived from them. Using this repository, we demonstrate that large studies of acute leukemia PDXs that mimic human randomized clinical trials can characterize drug efficacy and generate transcriptional, functional and proteomic biomarkers in both treatment-naïve and relapsed/refractory disease. PMID:27070704

  16. The Human Right to Adequate Housing: A Tool for Promoting and Protecting Individual and Community Health

    PubMed Central

    Thiele, Bret

    2002-01-01

    The human right to adequate housing is enshrined in international law. The right to adequate housing can be traced to the Universal Declaration of Human Rights, which was unanimously adopted by the world community in 1948. Since that time, the right to adequate housing has been reaffirmed on numerous occasions and further defined and elaborated. A key component of this right is habitability of housing, which should comply with health and safety standards. Therefore, the right to adequate housing provides an additional tool for advocates and others interested in promoting healthful housing and living conditions and thereby protecting individual and community health. PMID:11988432

  17. The primary outcome measure and its importance in clinical trials.

    PubMed

    Andrade, Chittaranjan

    2015-10-01

    The primary outcome measure is the outcome that an investigator considers to be the most important among the many outcomes that are to be examined in the study. The primary outcome needs to be defined at the time the study is designed. There are 2 reasons for this: it reduces the risk of false-positive errors resulting from the statistical testing of many outcomes, and it reduces the risk of a false-negative error by providing the basis for the estimation of the sample size necessary for an adequately powered study. This article discusses the setting of the primary outcome measure, the need for it, the increased risk of false-positive and false-negative errors in secondary outcome results, how to regard articles that do not state the primary outcome, how to interpret results when secondary outcomes are statistically significant but not the primary outcome, and limitations of the concept of a primary outcome measure in clinical trial research.

  18. Global Uranium And Thorium Resources: Are They Adequate To Satisfy Demand Over The Next Half Century?

    NASA Astrophysics Data System (ADS)

    Lambert, I. B.

    2012-04-01

    This presentation will consider the adequacy of global uranium and thorium resources to meet realistic nuclear power demand scenarios over the next half century. It is presented on behalf of, and based on evaluations by, the Uranium Group - a joint initiative of the OECD Nuclear Energy Agency and the International Atomic Energy Agency, of which the author is a Vice Chair. The Uranium Group produces a biennial report on Uranium Resources, Production and Demand based on information from some 40 countries involved in the nuclear fuel cycle, which also briefly reviews thorium resources. Uranium: In 2008, world production of uranium amounted to almost 44,000 tonnes (tU). This supplied approximately three-quarters of world reactor requirements (approx. 59,000 tU), the remainder being met by previously mined uranium (so-called secondary sources). Information on availability of secondary sources - which include uranium from excess inventories, dismantling nuclear warheads, tails and spent fuel reprocessing - is incomplete, but such sources are expected to decrease in market importance after 2013. In 2008, the total world Reasonably Assured plus Inferred Resources of uranium (recoverable at less than 130/kgU) amounted to 5.4 million tonnes. In addition, it is clear that there are vast amounts of uranium recoverable at higher costs in known deposits, plus many as yet undiscovered deposits. The Uranium Group has concluded that the uranium resource base is more than adequate to meet projected high-case requirements for nuclear power for at least half a century. This conclusion does not assume increasing replacement of uranium by fuels from reprocessing current reactor wastes, or by thorium, nor greater reactor efficiencies, which are likely to ameliorate future uranium demand. However, progressively increasing quantities of uranium will need to be mined, against a backdrop of the relatively small number of producing facilities around the world, geopolitical uncertainties and

  19. 9 CFR 2.40 - Attending veterinarian and adequate veterinary care (dealers and exhibitors).

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... veterinary care (dealers and exhibitors). 2.40 Section 2.40 Animals and Animal Products ANIMAL AND PLANT... and Adequate Veterinary Care § 2.40 Attending veterinarian and adequate veterinary care (dealers and... veterinary care to its animals in compliance with this section. (1) Each dealer and exhibitor shall employ...

  20. 9 CFR 2.33 - Attending veterinarian and adequate veterinary care.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... veterinary care. 2.33 Section 2.33 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE... adequate veterinary care. (a) Each research facility shall have an attending veterinarian who shall provide adequate veterinary care to its animals in compliance with this section: (1) Each research facility...

  1. 40 CFR 152.20 - Exemptions for pesticides adequately regulated by another Federal agency.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Exemptions for pesticides adequately... PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Exemptions § 152.20 Exemptions for pesticides adequately regulated by another Federal agency. The...

  2. 40 CFR 152.20 - Exemptions for pesticides adequately regulated by another Federal agency.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 25 2013-07-01 2013-07-01 false Exemptions for pesticides adequately... PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Exemptions § 152.20 Exemptions for pesticides adequately regulated by another Federal agency. The...

  3. 40 CFR 152.20 - Exemptions for pesticides adequately regulated by another Federal agency.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Exemptions for pesticides adequately... PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Exemptions § 152.20 Exemptions for pesticides adequately regulated by another Federal agency. The...

  4. 40 CFR 152.20 - Exemptions for pesticides adequately regulated by another Federal agency.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 25 2012-07-01 2012-07-01 false Exemptions for pesticides adequately... PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Exemptions § 152.20 Exemptions for pesticides adequately regulated by another Federal agency. The...

  5. 40 CFR 152.20 - Exemptions for pesticides adequately regulated by another Federal agency.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Exemptions for pesticides adequately... PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Exemptions § 152.20 Exemptions for pesticides adequately regulated by another Federal agency. The...

  6. 42 CFR 417.568 - Adequate financial records, statistical data, and cost finding.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 3 2013-10-01 2013-10-01 false Adequate financial records, statistical data, and....568 Adequate financial records, statistical data, and cost finding. (a) Maintenance of records. (1) An HMO or CMP must maintain sufficient financial records and statistical data for proper determination...

  7. 42 CFR 417.568 - Adequate financial records, statistical data, and cost finding.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 3 2014-10-01 2014-10-01 false Adequate financial records, statistical data, and....568 Adequate financial records, statistical data, and cost finding. (a) Maintenance of records. (1) An HMO or CMP must maintain sufficient financial records and statistical data for proper determination...

  8. 42 CFR 417.568 - Adequate financial records, statistical data, and cost finding.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 3 2012-10-01 2012-10-01 false Adequate financial records, statistical data, and....568 Adequate financial records, statistical data, and cost finding. (a) Maintenance of records. (1) An HMO or CMP must maintain sufficient financial records and statistical data for proper determination...

  9. 42 CFR 438.207 - Assurances of adequate capacity and services.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 4 2012-10-01 2012-10-01 false Assurances of adequate capacity and services. 438... Improvement Access Standards § 438.207 Assurances of adequate capacity and services. (a) Basic rule. The State... provides supporting documentation that demonstrates that it has the capacity to serve the...

  10. 42 CFR 438.207 - Assurances of adequate capacity and services.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 4 2014-10-01 2014-10-01 false Assurances of adequate capacity and services. 438... Improvement Access Standards § 438.207 Assurances of adequate capacity and services. (a) Basic rule. The State... provides supporting documentation that demonstrates that it has the capacity to serve the...

  11. 42 CFR 438.207 - Assurances of adequate capacity and services.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 4 2011-10-01 2011-10-01 false Assurances of adequate capacity and services. 438... Improvement Access Standards § 438.207 Assurances of adequate capacity and services. (a) Basic rule. The State... provides supporting documentation that demonstrates that it has the capacity to serve the...

  12. 42 CFR 438.207 - Assurances of adequate capacity and services.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 4 2013-10-01 2013-10-01 false Assurances of adequate capacity and services. 438... Improvement Access Standards § 438.207 Assurances of adequate capacity and services. (a) Basic rule. The State... provides supporting documentation that demonstrates that it has the capacity to serve the...

  13. 9 CFR 2.33 - Attending veterinarian and adequate veterinary care.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ..., DEPARTMENT OF AGRICULTURE ANIMAL WELFARE REGULATIONS Research Facilities § 2.33 Attending veterinarian and adequate veterinary care. (a) Each research facility shall have an attending veterinarian who shall provide adequate veterinary care to its animals in compliance with this section: (1) Each research facility...

  14. 9 CFR 2.33 - Attending veterinarian and adequate veterinary care.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ..., DEPARTMENT OF AGRICULTURE ANIMAL WELFARE REGULATIONS Research Facilities § 2.33 Attending veterinarian and adequate veterinary care. (a) Each research facility shall have an attending veterinarian who shall provide adequate veterinary care to its animals in compliance with this section: (1) Each research facility...

  15. What is the ideal dose and power output of low-level laser therapy (810 nm) on muscle performance and post-exercise recovery? Study protocol for a double-blind, randomized, placebo-controlled trial

    PubMed Central

    2014-01-01

    Background Recent studies involving phototherapy applied prior to exercise have demonstrated positive results regarding the attenuation of muscle fatigue and the expression of biochemical markers associated with recovery. However, a number of factors remain unknown, such as the ideal dose and application parameters, mechanisms of action and long-term effects on muscle recovery. The aims of the proposed project are to evaluate the long-term effects of low-level laser therapy on post-exercise musculoskeletal recovery and identify the best dose andapplication power/irradiation time. Design and methods A double-blind, randomized, placebo-controlled clinical trial with be conducted. After fulfilling the eligibility criteria, 28 high-performance athletes will be allocated to four groups of seven volunteers each. In phase 1, the laser power will be 200 mW and different doses will be tested: Group A (2 J), Group B (6 J), Group C (10 J) and Group D (0 J). In phase 2, the best dose obtained in phase 1 will be used with the same distribution of the volunteers, but with different powers: Group A (100 mW), Group B (200 mW), Group C (400 mW) and Group D (0 mW). The isokinetic test will be performed based on maximum voluntary contraction prior to the application of the laser and after the eccentric contraction protocol, which will also be performed using the isokinetic dynamometer. The following variables related to physical performance will be analyzed: peak torque/maximum voluntary contraction, delayed onset muscle soreness (algometer), biochemical markers of muscle damage, inflammation and oxidative stress. Discussion Our intention, is to determine optimal laser therapy application parameters capable of slowing down the physiological muscle fatigue process, reducing injuries or micro-injuries in skeletal muscle stemming from physical exertion and accelerating post-exercise muscle recovery. We believe that, unlike drug therapy, LLLT has a biphasic dose–response pattern. Trial

  16. 45 CFR 1159.15 - Who has the responsibility for maintaining adequate technical, physical, and security safeguards...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... adequate technical, physical, and security safeguards to prevent unauthorized disclosure or destruction of... adequate technical, physical, and security safeguards to prevent unauthorized disclosure or destruction of... of maintaining adequate technical, physical, and security safeguards to prevent...

  17. 45 CFR 1159.15 - Who has the responsibility for maintaining adequate technical, physical, and security safeguards...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... adequate technical, physical, and security safeguards to prevent unauthorized disclosure or destruction of... adequate technical, physical, and security safeguards to prevent unauthorized disclosure or destruction of... of maintaining adequate technical, physical, and security safeguards to prevent...

  18. Evolution of ischemic damage and behavioural deficit over 6 months after MCAo in the rat: Selecting the optimal outcomes and statistical power for multi-centre preclinical trials.

    PubMed

    Rewell, Sarah S J; Churilov, Leonid; Sidon, T Kate; Aleksoska, Elena; Cox, Susan F; Macleod, Malcolm R; Howells, David W

    2017-01-01

    Key disparities between the timing and methods of assessment in animal stroke studies and clinical trial may be part of the reason for the failure to translate promising findings. This study investigates the development of ischemic damage after thread occlusion MCAo in the rat, using histological and behavioural outcomes. Using the adhesive removal test we investigate the longevity of behavioural deficit after ischemic stroke in rats, and examine the practicality of using such measures as the primary outcome for future studies. Ischemic stroke was induced in 132 Spontaneously Hypertensive Rats which were assessed for behavioural and histological deficits at 1, 3, 7, 14, 21, 28 days, 12 and 24 weeks (n>11 per timepoint). The basic behavioural score confirmed induction of stroke, with deficits specific to stroke animals. Within 7 days, these deficits resolved in 50% of animals. The adhesive removal test revealed contralateral neglect for up to 6 months following stroke. Sample size calculations to facilitate the use of this test as the primary experimental outcome resulted in cohort sizes much larger than are the norm for experimental studies. Histological damage progressed from a necrotic infarct to a hypercellular area that cleared to leave a fluid filled cavity. Whilst absolute volume of damage changed over time, when corrected for changes in hemispheric volume, an equivalent area of damage was lost at all timepoints. Using behavioural measures at chronic timepoints presents significant challenges to the basic science community in terms of the large number of animals required and the practicalities associated with this. Multicentre preclinical randomised controlled trials as advocated by the MultiPART consortium may be the only practical way to deal with this issue.

  19. Evolution of ischemic damage and behavioural deficit over 6 months after MCAo in the rat: Selecting the optimal outcomes and statistical power for multi-centre preclinical trials

    PubMed Central

    Churilov, Leonid; Sidon, T. Kate; Aleksoska, Elena; Cox, Susan F.; Macleod, Malcolm R.; Howells, David W.

    2017-01-01

    Key disparities between the timing and methods of assessment in animal stroke studies and clinical trial may be part of the reason for the failure to translate promising findings. This study investigates the development of ischemic damage after thread occlusion MCAo in the rat, using histological and behavioural outcomes. Using the adhesive removal test we investigate the longevity of behavioural deficit after ischemic stroke in rats, and examine the practicality of using such measures as the primary outcome for future studies. Ischemic stroke was induced in 132 Spontaneously Hypertensive Rats which were assessed for behavioural and histological deficits at 1, 3, 7, 14, 21, 28 days, 12 and 24 weeks (n>11 per timepoint). The basic behavioural score confirmed induction of stroke, with deficits specific to stroke animals. Within 7 days, these deficits resolved in 50% of animals. The adhesive removal test revealed contralateral neglect for up to 6 months following stroke. Sample size calculations to facilitate the use of this test as the primary experimental outcome resulted in cohort sizes much larger than are the norm for experimental studies. Histological damage progressed from a necrotic infarct to a hypercellular area that cleared to leave a fluid filled cavity. Whilst absolute volume of damage changed over time, when corrected for changes in hemispheric volume, an equivalent area of damage was lost at all timepoints. Using behavioural measures at chronic timepoints presents significant challenges to the basic science community in terms of the large number of animals required and the practicalities associated with this. Multicentre preclinical randomised controlled trials as advocated by the MultiPART consortium may be the only practical way to deal with this issue. PMID:28182727

  20. Stroke Trials Registry

    MedlinePlus

    ... News About Neurology Image Library Search The Internet Stroke Center Trials Registry Clinical Trials Interventions Conditions Sponsors ... a clinical trial near you Welcome to the Stroke Trials Registry Our registry of clinical trials in ...

  1. Inferential Processing among Adequate and Struggling Adolescent Comprehenders and Relations to Reading Comprehension

    PubMed Central

    Barth, Amy E.; Barnes, Marcia; Francis, David J.; Vaughn, Sharon; York, Mary

    2015-01-01

    Separate mixed model analyses of variance (ANOVA) were conducted to examine the effect of textual distance on the accuracy and speed of text consistency judgments among adequate and struggling comprehenders across grades 6–12 (n = 1203). Multiple regressions examined whether accuracy in text consistency judgments uniquely accounted for variance in comprehension. Results suggest that there is considerable growth across the middle and high school years, particularly for adequate comprehenders in those text integration processes that maintain local coherence. Accuracy in text consistency judgments accounted for significant unique variance for passage-level, but not sentence-level comprehension, particularly for adequate comprehenders. PMID:26166946

  2. Using Multitheory Model of Health Behavior Change to Predict Adequate Sleep Behavior.

    PubMed

    Knowlden, Adam P; Sharma, Manoj; Nahar, Vinayak K

    The purpose of this article was to use the multitheory model of health behavior change in predicting adequate sleep behavior in college students. A valid and reliable survey was administered in a cross-sectional design (n = 151). For initiation of adequate sleep behavior, the construct of behavioral confidence (P < .001) was found to be significant and accounted for 24.4% of the variance. For sustenance of adequate sleep behavior, changes in social environment (P < .02), emotional transformation (P < .001), and practice for change (P < .001) were significant and accounted for 34.2% of the variance.

  3. Effects of Different Concurrent Resistance and Aerobic Training Frequencies on Muscle Power and Muscle Quality in Trained Elderly Men: A Randomized Clinical Trial

    PubMed Central

    Ferrari, Rodrigo; Fuchs, Sandra C.; Kruel, Luiz Fernando Martins; Cadore, Eduardo Lusa; Alberton, Cristine Lima; Pinto, Ronei Silveira; Radaelli, Régis; Schoenell, Maira; Izquierdo, Mikel; Tanaka, Hirofumi; Umpierre, Daniel

    2016-01-01

    Muscle power is a strong predictor of functional status in the elderly population and is required to perform different daily activities. To compare the effects of different weekly training frequencies on muscle power and muscle quality induced by concurrent training (resistance + aerobic) in previously trained elderly men. Twenty-four trained elderly men (65 ± 4 years), previously engaged in a regular concurrent training program, three times per week, for the previous five months, were randomly allocated to concurrent training programs in which training was performed either twice a week (2·week-1, n = 12) or three times per week (3·week-1, n = 12). The groups trained with an identical exercise intensity and volume per session for 10 weeks. Before and after the exercise training, we examined muscle power, as estimated by countermovement jump height; knee extensor isokinetic peak torque at 60 and 180o.s-1; and muscle quality, a quotient between the one-repetition maximum of the knee extensors and the sum of quadriceps femoris muscle thickness determined by ultrasonography. Additionally, as secondary outcomes, blood pressure and reactive hyperemia were evaluated. Two-way ANOVA with repeated measures were used and statistical significance was set at α = 0.05. Muscular power (2·week-1: 7%, and 3·week-1: 10%) and muscle quality (2·week-1: 15%, and 3·week-1: 8%) improved with the concurrent exercise training (p < 0.001) but with no differences between groups. The isokinetic peak torque at 60 (2·week-1: 4%, and 3·week-1: 2%) and 180o.s-1 (2·week-1: 7%, and 3·week-1: 1%) increased in both groups (p = 0.036 and p=0.014, respectively). There were no changes in blood pressure or reactive hyperemia with the concurrent training. Concurrent training performed twice a week promotes similar adaptations in muscular power and muscle quality when compared with the same program performed three times per week in previously trained elderly men. PMID:28053820

  4. Photovoltaic power systems workshop

    NASA Technical Reports Server (NTRS)

    Killian, H. J.; Given, R. W.

    1978-01-01

    Discussions are presented on apparent deficiencies in NASA planning and technology development relating to a standard power module (25-35 kW) and to future photovoltaic power systems in general. Topics of discussion consider the following: (1) adequate studies on power systems; (2) whether a standard power system module should be developed from a standard spacecraft; (3) identification of proper approaches to cost reduction; (4) energy storage avoidance; (5) attitude control; (6) thermal effects of heat rejection on solar array configuration stability; (7) assembly of large power systems in space; and (8) factoring terrestrial photovoltaic work into space power systems for possible payoff.

  5. Successful recruitment and retention strategies for a randomized weight management trial for people with diabetes living in rural, medically underserved counties of South Carolina: the POWER study.

    PubMed

    Parra-Medina, Deborah; D'antonio, Angela; Smith, Sharon M; Levin, Sarah; Kirkner, Gregory; Mayer-Davis, Elizabeth

    2004-01-01

    We evaluated the feasibility of recruiting overweight adults with diabetes, living in rural, medically underserved communities, to a weight management intervention consisting of a 12-month clinical trial of two weight management programs and usual care. The sampling frame consisted of adults ages 45 years and older with clinically diagnosed diabetes from two community health centers. The recruitment process included medical record review, prescreening telephone call, two screening visits, and a randomization visit. Over 1,400 medical records were reviewed; 78.6% met eligibility criteria; 60.1% were contacted for telephone prescreening, and 35.5% remained eligible and were interested in participating. Of these, 187 completed visit 1, 164 completed visit 2, and 143 were randomized. Forty-six people were randomized who entered the study as walk-ins at screening visit 1, resulting in 189 subjects. The final yield was 21.5%. Subject mean age was 60.4 years, mean body mass index was 36.4 kg/m(2), 80% were African-American, and 46.6% had less than a high school education. Retention at 12 months was 81.5%. Successful strategies included partnering with community health centers, positive reinforcement and social supportiveness, monitoring progress, and free transportation. This work provides a useful example of an academic-community partnership designed to reach groups previously considered hard to reach.

  6. Region 8: Colorado Lamar and Steamboat Springs Adequate Letter (11/12/2002)

    EPA Pesticide Factsheets

    This letter from EPA to Colorado Department of Public Health and Environment determined Lamar and Steamboat Springs particulate matter (PM10) maintenance plan for Motor Vehicle Emissions Budgets adequate for transportation conformity purposes

  7. 75 FR 5893 - Suspension of Community Eligibility for Failure To Maintain Adequate Floodplain Management...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-05

    ... To Maintain Adequate Floodplain Management Regulations AGENCY: Federal Emergency Management Agency... floodplain management regulations meeting minimum requirements under the National Flood Insurance Program... they have brought their floodplain management regulations into compliance with the NFIP...

  8. Region 9: California Adequate / Inadequate Letter Attachment (5/30/2008)

    EPA Pesticide Factsheets

    This is a document that states that it has been found adequate for transportation conformitypurposes certain 8-hour ozone and PM2.5 motor vehicleemissions budgets in the 2007 South Coast StateImplementation Plan.

  9. Adaptive clinical trial designs in oncology

    PubMed Central

    Zang, Yong; Lee, J. Jack

    2015-01-01

    Adaptive designs have become popular in clinical trial and drug development. Unlike traditional trial designs, adaptive designs use accumulating data to modify the ongoing trial without undermining the integrity and validity of the trial. As a result, adaptive designs provide a flexible and effective way to conduct clinical trials. The designs have potential advantages of improving the study power, reducing sample size and total cost, treating more patients with more effective treatments, identifying efficacious drugs for specific subgroups of patients based on their biomarker profiles, and shortening the time for drug development. In this article, we review adaptive designs commonly used in clinical trials and investigate several aspects of the designs, including the dose-finding scheme, interim analysis, adaptive randomization, biomarker-guided randomization, and seamless designs. For illustration, we provide examples of real trials conducted with adaptive designs. We also discuss practical issues from the perspective of using adaptive designs in oncology trials. PMID:25811018

  10. Individual and contextual determinants of adequate maternal health care services in Kenya.

    PubMed

    Achia, Thomas N O; Mageto, Lillian E

    2015-01-01

    This study aimed to examine individual and community level factors associated with adequate use of maternal antenatal health services in Kenya. Individual and community level factors associated with adequate use of maternal health care (MHC) services were obtained from the 2008-09 Kenya Demographic and Health Survey data set. Multilevel partial-proportional odds logit models were fitted using STATA 13.0 to quantify the relations of the selected covariates to adequate MHC use, defined as a three-category ordinal variable. The sample consisted of 3,621 women who had at least one live birth in the five-year period preceding this survey. Only 18 percent of the women had adequate use of MHC services. Greater educational attainment by the woman or her partner, higher socioeconomic status, access to medical insurance coverage, and greater media exposure were the individual-level factors associated with adequate use of MHC services. Greater community ethnic diversity, higher community-level socioeconomic status, and greater community-level health facility deliveries were the contextual-level factors associated with adequate use of MHC. To improve the use of MHC services in Kenya, the government needs to design and implement programs that target underlying individual and community level factors, providing focused and sustained health education to promote the use of antenatal, delivery, and postnatal care.

  11. Using simulation to aid trial design: Ring-vaccination trials

    PubMed Central

    Hitchings, Matt David Thomas; Grais, Rebecca Freeman

    2017-01-01

    Background The 2014–6 West African Ebola epidemic highlights the need for rigorous, rapid clinical trial methods for vaccines. A challenge for trial design is making sample size calculations based on incidence within the trial, total vaccine effect, and intracluster correlation, when these parameters are uncertain in the presence of indirect effects of vaccination. Methods and findings We present a stochastic, compartmental model for a ring vaccination trial. After identification of an index case, a ring of contacts is recruited and either vaccinated immediately or after 21 days. The primary outcome of the trial is total vaccine effect, counting cases only from a pre-specified window in which the immediate arm is assumed to be fully protected and the delayed arm is not protected. Simulation results are used to calculate necessary sample size and estimated vaccine effect. Under baseline assumptions about vaccine properties, monthly incidence in unvaccinated rings and trial design, a standard sample-size calculation neglecting dynamic effects estimated that 7,100 participants would be needed to achieve 80% power to detect a difference in attack rate between arms, while incorporating dynamic considerations in the model increased the estimate to 8,900. This approach replaces assumptions about parameters at the ring level with assumptions about disease dynamics and vaccine characteristics at the individual level, so within this framework we were able to describe the sensitivity of the trial power and estimated effect to various parameters. We found that both of these quantities are sensitive to properties of the vaccine, to setting-specific parameters over which investigators have little control, and to parameters that are determined by the study design. Conclusions Incorporating simulation into the trial design process can improve robustness of sample size calculations. For this specific trial design, vaccine effectiveness depends on properties of the ring

  12. The Trial

    ERIC Educational Resources Information Center

    Bryant, Jen

    2004-01-01

    Growing up in Flemington, New Jersey, put Jen Bryant in the heart of the lore behind the Lindbergh baby kidnapping. Family stories of the events of the day and extensive research led to "The Trial," a novel in verse. The first several parts of this novel are included here.

  13. Clinical Trials

    MedlinePlus

    ... trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a ... also compare a new treatment to a treatment that is already available. ...

  14. Clinical Trials

    MedlinePlus

    ... your information private 5. What happens when the study ends The Possible Risks and Benefits The trial may provide treatments or screenings, but there is no promise that your health will get better. The medicine, test, or treatment may not work for you. 6. The benefits of the treatments ...

  15. Statistical inference on censored data for targeted clinical trials under enrichment design.

    PubMed

    Chen, Chen-Fang; Lin, Jr-Rung; Liu, Jen-Pei

    2013-01-01

    For the traditional clinical trials, inclusion and exclusion criteria are usually based on some clinical endpoints; the genetic or genomic variability of the trial participants are not totally utilized in the criteria. After completion of the human genome project, the disease targets at the molecular level can be identified and can be utilized for the treatment of diseases. However, the accuracy of diagnostic devices for identification of such molecular targets is usually not perfect. Some of the patients enrolled in targeted clinical trials with a positive result for the molecular target might not have the specific molecular targets. As a result, the treatment effect may be underestimated in the patient population truly with the molecular target. To resolve this issue, under the exponential distribution, we develop inferential procedures for the treatment effects of the targeted drug based on the censored endpoints in the patients truly with the molecular targets. Under an enrichment design, we propose using the expectation-maximization algorithm in conjunction with the bootstrap technique to incorporate the inaccuracy of the diagnostic device for detection of the molecular targets on the inference of the treatment effects. A simulation study was conducted to empirically investigate the performance of the proposed methods. Simulation results demonstrate that under the exponential distribution, the proposed estimator is nearly unbiased with adequate precision, and the confidence interval can provide adequate coverage probability. In addition, the proposed testing procedure can adequately control the size with sufficient power. On the other hand, when the proportional hazard assumption is violated, additional simulation studies show that the type I error rate is not controlled at the nominal level and is an increasing function of the positive predictive value. A numerical example illustrates the proposed procedures.

  16. Randomization methods in emergency setting trials: a descriptive review

    PubMed Central

    Moe‐Byrne, Thirimon; Oddie, Sam; McGuire, William

    2015-01-01

    Background Quasi‐randomization might expedite recruitment into trials in emergency care settings but may also introduce selection bias. Methods We searched the Cochrane Library and other databases for systematic reviews of interventions in emergency medicine or urgent care settings. We assessed selection bias (baseline imbalances) in prognostic indicators between treatment groups in trials using true randomization versus trials using quasi‐randomization. Results Seven reviews contained 16 trials that used true randomization and 11 that used quasi‐randomization. Baseline group imbalance was identified in four trials using true randomization (25%) and in two quasi‐randomized trials (18%). Of the four truly randomized trials with imbalance, three concealed treatment allocation adequately. Clinical heterogeneity and poor reporting limited the assessment of trial recruitment outcomes. Conclusions We did not find strong or consistent evidence that quasi‐randomization is associated with selection bias more often than true randomization. High risk of bias judgements for quasi‐randomized emergency studies should therefore not be assumed in systematic reviews. Clinical heterogeneity across trials within reviews, coupled with limited availability of relevant trial accrual data, meant it was not possible to adequately explore the possibility that true randomization might result in slower trial recruitment rates, or the recruitment of less representative populations. © 2015 The Authors. Research Synthesis Methods published by John Wiley & Sons, Ltd. PMID:26333419

  17. Low-dose oxytocin delivered intranasally with Breath Powered device affects social-cognitive behavior: a randomized four-way crossover trial with nasal cavity dimension assessment.

    PubMed

    Quintana, D S; Westlye, L T; Rustan, Ø G; Tesli, N; Poppy, C L; Smevik, H; Tesli, M; Røine, M; Mahmoud, R A; Smerud, K T; Djupesland, P G; Andreassen, O A

    2015-07-14

    Despite the promise of intranasal oxytocin (OT) for modulating social behavior, recent work has provided mixed results. This may relate to suboptimal drug deposition achieved with conventional nasal sprays, inter-individual differences in nasal physiology and a poor understanding of how intranasal OT is delivered to the brain in humans. Delivering OT using a novel 'Breath Powered' nasal device previously shown to enhance deposition in intranasal sites targeted for nose-to-brain transport, we evaluated dose-dependent effects on social cognition, compared response with intravenous (IV) administration of OT, and assessed nasal cavity dimensions using acoustic rhinometry. We adopted a randomized, double-blind, double-dummy, crossover design, with 16 healthy male adults completing four single-dose treatments (intranasal 8 IU (international units) or 24 IU OT, 1 IU OT IV and placebo). The primary outcome was social cognition measured by emotional ratings of facial images. Secondary outcomes included the pharmacokinetics of OT, vasopressin and cortisol in blood and the association between nasal cavity dimensions and emotional ratings. Despite the fact that all the treatments produced similar plasma OT increases compared with placebo, there was a main effect of treatment on anger ratings of emotionally ambiguous faces. Pairwise comparisons revealed decreased ratings after 8 IU OT in comparison to both placebo and 24 IU OT. In addition, there was an inverse relationship between nasal valve dimensions and anger ratings of ambiguous faces after 8-IU OT treatment. These findings provide support for a direct nose-to-brain effect, independent of blood absorption, of low-dose OT delivered from a Breath Powered device.

  18. Assessment and Implication of Prognostic Imbalance in Randomized Controlled Trials with a Binary Outcome – A Simulation Study

    PubMed Central

    Chu, Rong; Walter, Stephen D.; Guyatt, Gordon; Devereaux, P. J.; Walsh, Michael; Thorlund, Kristian; Thabane, Lehana

    2012-01-01

    Background Chance imbalance in baseline prognosis of a randomized controlled trial can lead to over or underestimation of treatment effects, particularly in trials with small sample sizes. Our study aimed to (1) evaluate the probability of imbalance in a binary prognostic factor (PF) between two treatment arms, (2) investigate the impact of prognostic imbalance on the estimation of a treatment effect, and (3) examine the effect of sample size (n) in relation to the first two objectives. Methods We simulated data from parallel-group trials evaluating a binary outcome by varying the risk of the outcome, effect of the treatment, power and prevalence of the PF, and n. Logistic regression models with and without adjustment for the PF were compared in terms of bias, standard error, coverage of confidence interval and statistical power. Results For a PF with a prevalence of 0.5, the probability of a difference in the frequency of the PF≥5% reaches 0.42 with 125/arm. Ignoring a strong PF (relative risk = 5) leads to underestimating the strength of a moderate treatment effect, and the underestimate is independent of n when n is >50/arm. Adjusting for such PF increases statistical power. If the PF is weak (RR = 2), adjustment makes little difference in statistical inference. Conditional on a 5% imbalance of a powerful PF, adjustment reduces the likelihood of large bias. If an absolute measure of imbalance ≥5% is deemed important, including 1000 patients/arm provides sufficient protection against such an imbalance. Two thousand patients/arm may provide an adequate control against large random deviations in treatment effect estimation in the presence of a powerful PF. Conclusions The probability of prognostic imbalance in small trials can be substantial. Covariate adjustment improves estimation accuracy and statistical power, and hence should be performed when strong PFs are observed. PMID:22629322

  19. Infant skin-cleansing product versus water: A pilot randomized, assessor-blinded controlled trial

    PubMed Central

    2011-01-01

    Background The vulnerability of newborn babies' skin creates the potential for a number of skin problems. Despite this, there remains a dearth of good quality evidence to inform practice. Published studies comparing water with a skin-cleansing product have not provided adequate data to inform an adequately powered trial. Nor have they distinguished between babies with and without a predisposition to atopic eczema. We conducted a pilot study as a prequel to designing an optimum trial to investigate whether bathing with a specific cleansing product is superior to bathing with water alone. The aims were to produce baseline data which would inform decisions for the main trial design (i.e. population, primary outcome, sample size calculation) and to optimize the robustness of trial processes within the study setting. Methods 100 healthy, full term neonates aged <24 hours were randomly assigned to bathing with water and cotton wool (W) or with a cleaning product (CP). A minimum of bathing 3 times per week was advocated. Groups were stratified according to family history of atopic eczema. Transepidermal water loss (TEWL), stratum corneum hydration and skin surface pH were measured within 24 hours of birth and at 4 and 8 weeks post birth. Measurements were taken on the thigh, forearm and abdomen. Women also completed questionnaires and diaries to record bathing practices and medical treatments. Results Forty nine babies were randomized to cleansing product, 51 to water. The 95% confidence intervals (CI) for the average TEWL measurement at each time point were: whole sample at baseline: 10.8 g/m2/h to 11.7 g/m2/h; CP group 4 weeks: 10.9 g/m2/h to 13.3 g/m2/h; 8 weeks: 11.4 g/m2/h to 12.9 g/m2/h; W group 4 weeks:10.9 g/m2/h to 12.2 g/m2/h; 8 weeks: 11.4 g/m2/h to 12.9 g/m2/h. Conclusion This pilot study provided valuable baseline data and important information on trial processes. The decision to proceed with a superiority trial, for example, was inconsistent with our data

  20. Power Plant Water Intake Assessment.

    ERIC Educational Resources Information Center

    Zeitoun, Ibrahim H.; And Others

    1980-01-01

    In order to adequately assess the impact of power plant cooling water intake on an aquatic ecosystem, total ecosystem effects must be considered, rather than merely numbers of impinged or entrained organisms. (Author/RE)

  1. Temptations of Power and Certainty.

    ERIC Educational Resources Information Center

    Amundson, Jon; And Others

    1993-01-01

    Contends that, when therapists do not adequately account for the position of clients, they fall prey to temptation of certainty and that, when therapists attempt to impose corrections from such certainty, they fall prey to temptation of power. Offers suggestions for sidestepping power/certainty by contrasting therapies of power and certainty with…

  2. Trial Watch

    PubMed Central

    Galluzzi, Lorenzo; Vacchelli, Erika; Fridman, Wolf Hervé; Galon, Jerome; Sautès-Fridman, Catherine; Tartour, Eric; Zucman-Rossi, Jessica; Zitvogel, Laurence; Kroemer, Guido

    2012-01-01

    Since the advent of hybridoma technology, dating back to 1975, monoclonal antibodies have become an irreplaceable diagnostic and therapeutic tool for a wide array of human diseases. During the last 15 years, several monoclonal antibodies (mAbs) have been approved by FDA for cancer therapy. These mAbs are designed to (1) activate the immune system against tumor cells, (2) inhibit cancer cell-intrinsic signaling pathways, (3) bring toxins in the close proximity of cancer cells, or (4) interfere with the tumor-stroma interaction. More recently, major efforts have been made for the development of immunostimulatory mAbs that either enhance cancer-directed immune responses or limit tumor- (or therapy-) driven immunosuppression. Some of these antibodies, which are thought to facilitate tumor eradication by initiating or sustaining a tumor-specific immune response, have already entered clinical trials. In this Trial Watch, we will review and discuss the clinical progress of the most important mAbs that are have entered clinical trials after January 2008. PMID:22720209

  3. Precise ablation of dental hard tissues with ultra-short pulsed lasers. Preliminary exploratory investigation on adequate laser parameters.

    PubMed

    Bello-Silva, Marina Stella; Wehner, Martin; Eduardo, Carlos de Paula; Lampert, Friedrich; Poprawe, Reinhart; Hermans, Martin; Esteves-Oliveira, Marcella

    2013-01-01

    This study aimed to evaluate the possibility of introducing ultra-short pulsed lasers (USPL) in restorative dentistry by maintaining the well-known benefits of lasers for caries removal, but also overcoming disadvantages, such as thermal damage of irradiated substrate. USPL ablation of dental hard tissues was investigated in two phases. Phase 1--different wavelengths (355, 532, 1,045, and 1,064 nm), pulse durations (picoseconds and femtoseconds) and irradiation parameters (scanning speed, output power, and pulse repetition rate) were assessed for enamel and dentin. Ablation rate was determined, and the temperature increase measured in real time. Phase 2--the most favorable laser parameters were evaluated to correlate temperature increase to ablation rate and ablation efficiency. The influence of cooling methods (air, air-water spray) on ablation process was further analyzed. All parameters tested provided precise and selective tissue ablation. For all lasers, faster scanning speeds resulted in better interaction and reduced temperature increase. The most adequate results were observed for the 1064-nm ps-laser and the 1045-nm fs-laser. Forced cooling caused moderate changes in temperature increase, but reduced ablation, being considered unnecessary during irradiation with USPL. For dentin, the correlation between temperature increase and ablation efficiency was satisfactory for both pulse durations, while for enamel, the best correlation was observed for fs-laser, independently of the power used. USPL may be suitable for cavity preparation in dentin and enamel, since effective ablation and low temperature increase were observed. If adequate laser parameters are selected, this technique seems to be promising for promoting the laser-assisted, minimally invasive approach.

  4. Importance of adequate exercise in the detection of coronary heart disease by radionuclide ventriculography

    SciTech Connect

    Brady, T.J.; Thrall, J.H.; Lo, K.; Pitt, B.

    1980-12-01

    Rest and exercise radionuclide ventriculograms were obtained on 77 symptomatic patients without prior documented coronary artery disease (CAD). Coronary artery disease was present by angiograms in 48. Radionuclide ventriculography (RNV) was abnormal in 41 patients (overall sensitivity 85%). In 29 patients with normal coronary arteries, RNV was normal in 24 (specificity 83%). To determine if the exercise level affects sensitivity, the studies were graded for adequacy of exercise. It was considered adequate if patients developed (a) chest pain, or (b) ST segment depression of at least 1 mm, or (c) if they achieved a pressure rate product greater than 250. Among the 48 patients with coronary artery disease, 35 achieved adequate exercise. Thirty-three had an abnormal RNV (sensitivity 94%). In 13 patients who failed to achieve adequate exercise, RNV was abnormal in eight (sensitivity of only 62%). Some patients with coronary artery disease may have a normal ventricular response at inadequate levels of stress.

  5. [Prevention of ocular complications of herpes zoster ophthalmicus by adequate treatment with acyclovir].

    PubMed

    Borruat, F X; Buechi, E R; Piguet, B; Fitting, P; Zografos, L; Herbort, C P

    1991-05-01

    We compared the frequency of severe ocular complications secondary to Herpes Zoster Ophthalmicus (HZO) in 232 patients. They were divided into three groups: 1) patients without treatment (n = 164); 2) patients treated adequately (n = 48) with acyclovir (ACV; 5 x 800 mg/d orally and ophthalmic ointment 5 x /d for a minimum of 7 days, given within three days after skin eruption); and, 3) patients treated inadequately (n = 20) with ACV (only topical treatment, insufficient doses, interrupted treatment, delayed treatment). Patients with no treatment or with inadequate treatments showed the same frequency of severe ocular complications (21% (34/164) and 25% (5/20), respectively). In contrast, when adequate treatment of ACV was given complications occurred in only 4% (2/48) of cases. This study emphasizes the need for prompt (within three days after skin eruption) and adequate (5 x 800 mg/d for at least 7 days) treatment of ACV to prevent the severe complications of HZO.

  6. Broadband inversion of 1J(CC) responses in 1,n-ADEQUATE spectra.

    PubMed

    Reibarkh, Mikhail; Williamson, R Thomas; Martin, Gary E; Bermel, Wolfgang

    2013-11-01

    Establishing the carbon skeleton of a molecule greatly facilitates the process of structure elucidation, both manual and computer-assisted. Recent advances in the family of ADEQUATE experiments demonstrated their potential in this regard. 1,1-ADEQUATE, which provides direct (13)C-(13)C correlation via (1)J(CC), and 1,n-ADEQUATE, which typically yields (3)J(CC) and (1)J(CC) correlations, are more sensitive and more widely applicable experiments than INADEQUATE and PANACEA. A recently reported modified pulse sequence that semi-selectively inverts (1)J(CC) correlations in 1,n-ADEQUATE spectra provided a significant improvement, allowing (1)J(CC) and (n)J(CC) correlations to be discerned in the same spectrum. However, the reported experiment requires a careful matching of the amplitude transfer function with (1)J(CC) coupling constants in order to achieve the inversion, and even then some (1)J(CC) correlations could still have positive intensity due to the oscillatory nature of the transfer function. Both shortcomings limit the practicality of the method. We now report a new, dual-optimized inverted (1)J(CC) 1,n-ADEQUATE experiment, which provides more uniform inversion of (1)J(CC) correlations across the range of 29-82 Hz. Unlike the original method, the dual optimization experiment does not require fine-tuning for the molecule's (1)J(CC) coupling constant values. Even more usefully, the dual-optimized version provides up to two-fold improvement in signal-to-noise for some long-range correlations. Using modern, cryogenically-cooled probes, the experiment can be successfully applied to samples of ~1 mg under favorable circumstances. The improvements afforded by dual optimization inverted (1)J(CC) 1,n-ADEQUATE experiment make it a useful and practical tool for NMR structure elucidation and should facilitate the implementation and utilization of the experiment.

  7. Self-reported segregation experience throughout the life course and its association with adequate health literacy.

    PubMed

    Goodman, Melody S; Gaskin, Darrell J; Si, Xuemei; Stafford, Jewel D; Lachance, Christina; Kaphingst, Kimberly A

    2012-09-01

    Residential segregation has been shown to be associated with health outcomes and health care utilization. We examined the association between racial composition of five physical environments throughout the life course and adequate health literacy among 836 community health center patients in Suffolk County, NY. Respondents who attended a mostly White junior high school or currently lived in a mostly White neighborhood were more likely to have adequate health literacy compared to those educated or living in predominantly minority or diverse environments. This association was independent of the respondent's race, ethnicity, age, education, and country of birth.

  8. Self-reported segregation experience throughout the life course and its association with adequate health literacy

    PubMed Central

    Gaskin, Darrell J.; Si, Xuemei; Stafford, Jewel D.; Lachance, Christina; Kaphingst, Kimberly A.

    2012-01-01

    Residential segregation has been shown to be associated with health outcomes and health care utilization. We examined the association between racial composition of five physical environments throughout the life course and adequate health literacy among 836 community health center patients in Suffolk County, NY. Respondents who attended a mostly White junior high school or currently lived in a mostly White neighborhood were more likely to have adequate health literacy compared to those educated or living in predominantly minority or diverse environments. This association was independent of the respondent’s race, ethnicity, age, education, and country of birth. PMID:22658579

  9. The Trial of Mid-Urethral Slings (TOMUS): Design and Methodology

    PubMed Central

    2013-01-01

    Objective Mid-urethral slings (MUS) are increasingly common surgical procedures for the treatment of stress urinary incontinence (SUI) in women. There are currently no adequately powered trials with sufficient length of follow-up comparing the efficacy or safety of the transobturator and retropubic MUS. As a result, no selection criteria are available to guide surgeons or patients. This article describes the methodology and rationale for the Trial Of Mid-Urethral Slings (TOMUS). Patients and Methods The primary aims of this randomized controlled trial is to compare subjective and objective success rates for urinary incontinence (UI) at 12 and 24 months following retropubic and transobturator MUS procedures. Secondary aims are to compare the resolution of overall and stress-specific UI, morbidity, the time to adequate voiding, satisfaction, and quality of life in the two groups. TOMUS will also assess the clinical utility of pre-operative urodynamics in women undergoing MUS procedures. The primary outcome will be obtained at 12 months and 24 months. The definition of treatment success is two-fold. Objective treatment success is defined by a negative stress test, a negative 24-hour pad test and no retreatment for SUI. Subjective treatment success is defined by no self-reported leakage on 3-day diary and no self-reported SUI symptoms. Enrollment began April 2006 and is expected to be complete in 2 years. Conclusions The TOMUS trial is designed to provide outcome and safety information to pelvic surgeons and their patients on the two most commonly performed MUS techniques. PMID:24772006

  10. Do the Operational Operating Systems Offer an Adequate Framework for the Synchronization of Combat Power at the Operational Level

    DTIC Science & Technology

    1993-05-14

    p. 15. 15 Ibid p. 15. 16 John Morgan Dederer Making Bricks Without Straw (Manhattan, Kansas, Sunflower University Press,1983), p. 2 17 W. Robert... Dederer , John M. Making Bricks Without Straw. Manhzitan, Kansas: Sunflower University Press, 1983. Evans, Geoffrey. Slim as Military Commander

  11. Stabilized Acoustic Levitation of Dense Materials Using a High-Powered Siren

    NASA Technical Reports Server (NTRS)

    Gammell, P. M.; Croonquist, A.; Wang, T. G.

    1982-01-01

    Stabilized acoustic levitation and manipulation of dense (e.g., steel) objects of 1 cm diameter, using a high powered siren, was demonstrated in trials that investigated the harmonic content and spatial distribution of the acoustic field, as well as the effect of sample position and reflector geometries on the acoustic field. Although further optimization is possible, the most stable operation achieved is expected to be adequate for most containerless processing applications. Best stability was obtained with an open reflector system, using a flat lower reflector and a slightly concave upper one. Operation slightly below resonance enhances stability as this minimizes the second harmonic, which is suspected of being a particularly destabilizing influence.

  12. Stabilized acoustic levitation of dense materials using a high-powered siren

    NASA Astrophysics Data System (ADS)

    Gammell, P. M.; Croonquist, A.; Wang, T. G.

    1982-12-01

    Stabilized acoustic levitation and manipulation of dense (e.g., steel) objects of 1 cm diameter, using a high powered siren, was demonstrated in trials that investigated the harmonic content and spatial distribution of the acoustic field, as well as the effect of sample position and reflector geometries on the acoustic field. Although further optimization is possible, the most stable operation achieved is expected to be adequate for most containerless processing applications. Best stability was obtained with an open reflector system, using a flat lower reflector and a slightly concave upper one. Operation slightly below resonance enhances stability as this minimizes the second harmonic, which is suspected of being a particularly destabilizing influence.

  13. Contemporary treatment of heart failure: is there adequate evidence to support a unique strategy for African-Americans? Con position.

    PubMed

    Ferdinand, Keith C; Serrano, Claudia C; Ferdinand, Daphne P

    2002-08-01

    Heart failure is a substantial cause of increased morbidity and mortality in the African-American population, with poorer prognosis versus white patients. Systolic heart failure is predominantly caused by poorly controlled hypertension in African-Americans. Overall, African-Americans remain underrepresented in morbidity and mortality heart failure trials, and further data are needed to confirm the potential benefit of present therapies and newer approaches to heart failure in African-Americans. Intensive blood pressure control and control of other risk factors, along with the appropriate application of evidence-based therapies including angiotensin converting enzyme (ACE) inhibitors and approved beta-blockers, are required to decrease racial disparities. Although some data suggest that contemporary treatment with ACE inhibitors and beta-blockers may be less effective in African-Americans in terms of reducing heart failure morbidity and mortality, there is not adequate evidence to support a unique strategy for this population. The use of evidence-based therapies should be equally applied to African-Americans as well as to other ethnic groups while awaiting further studies.

  14. 75 FR 69648 - Safety Analysis Requirements for Defining Adequate Protection for the Public and the Workers

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-15

    ... ENERGY Safety Analysis Requirements for Defining Adequate Protection for the Public and the Workers... designed to hold firmly in place. 10 CFR Part 830 imposes a requirement that a documented safety analysis... provide guidance on meeting the requirements imposed by DOE Order 5480.23, Nuclear Safety Analysis...

  15. 42 CFR 413.24 - Adequate cost data and cost finding.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    .... Adequate data capable of being audited is consistent with good business concepts and effective and efficient management of any organization, whether it is operated for profit or on a nonprofit basis. It is a... contract for services (for example, a management contract), directly assigning the costs to the...

  16. Prenatal zinc supplementation of zinc-adequate rats adversely affects immunity in offspring

    Technology Transfer Automated Retrieval System (TEKTRAN)

    We previously showed that zinc (Zn) supplementation of Zn-adequate dams induced immunosuppressive effects that persist in the offspring after weaning. We investigated whether the immunosuppressive effects were due to in utero exposure and/or mediated via milk using a cross-fostering design. Pregnant...

  17. ADEQUATE SHELTERS AND QUICK REACTIONS TO WARNING: A KEY TO CIVIL DEFENSE.

    PubMed

    LYNCH, F X

    1963-11-08

    Case histories collected by investigators in Japan during 1945 illustrate both the effectiveness of shelters and the dangers inherent in apathy of the population, which suffered needless casualties by ignoring air raid warnintgs. Adequate shelters and immediate response to warnings are essential to survival in nuclear attack.

  18. Perceptions of Teachers in Their First Year of School Restructuring: Failure to Make Adequate Yearly Progress

    ERIC Educational Resources Information Center

    Moser, Sharon

    2010-01-01

    The 2007-2008 school year marked the first year Florida's Title I schools that did not made Adequate Yearly Progress (AYP) for five consecutive years entered into restructuring as mandated by the "No Child Left Behind Act" of 2001. My study examines the perceptions of teacher entering into their first year of school restructuring due to…

  19. 45 CFR 1182.15 - Institute responsibility for maintaining adequate technical, physical, and security safeguards to...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... record systems. These security safeguards shall apply to all systems in which identifiable personal data... data and automated systems shall be adequately trained in the security and privacy of personal data. (4... technical, physical, and security safeguards to prevent unauthorized disclosure or destruction of manual...

  20. 42 CFR 417.568 - Adequate financial records, statistical data, and cost finding.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 3 2011-10-01 2011-10-01 false Adequate financial records, statistical data, and... financial records, statistical data, and cost finding. (a) Maintenance of records. (1) An HMO or CMP must maintain sufficient financial records and statistical data for proper determination of costs payable by...

  1. Effect of tranquilizers on animal resistance to the adequate stimuli of the vestibular apparatus

    NASA Technical Reports Server (NTRS)

    Maksimovich, Y. B.; Khinchikashvili, N. V.

    1980-01-01

    The effect of tranquilizers on vestibulospinal reflexes and motor activity was studied in 900 centrifuged albino mice. Actometric studies have shown that the tranquilizers have a group capacity for increasing animal resistance to the action of adequate stimuli to the vestibular apparatus.

  2. 9 CFR 2.40 - Attending veterinarian and adequate veterinary care (dealers and exhibitors).

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Attending veterinarian and adequate veterinary care (dealers and exhibitors). 2.40 Section 2.40 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE ANIMAL WELFARE REGULATIONS Attending...

  3. 9 CFR 2.40 - Attending veterinarian and adequate veterinary care (dealers and exhibitors).

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Attending veterinarian and adequate veterinary care (dealers and exhibitors). 2.40 Section 2.40 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE ANIMAL WELFARE REGULATIONS Attending...

  4. 9 CFR 2.40 - Attending veterinarian and adequate veterinary care (dealers and exhibitors).

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Attending veterinarian and adequate veterinary care (dealers and exhibitors). 2.40 Section 2.40 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE ANIMAL WELFARE REGULATIONS Attending...

  5. 9 CFR 2.40 - Attending veterinarian and adequate veterinary care (dealers and exhibitors).

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Attending veterinarian and adequate veterinary care (dealers and exhibitors). 2.40 Section 2.40 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE ANIMAL WELFARE REGULATIONS Attending...

  6. The Relationship between Parental Involvement and Adequate Yearly Progress among Urban, Suburban, and Rural Schools

    ERIC Educational Resources Information Center

    Ma, Xin; Shen, Jianping; Krenn, Huilan Y.

    2014-01-01

    Using national data from the 2007-08 School and Staffing Survey, we compared the relationships between parental involvement and school outcomes related to adequate yearly progress (AYP) in urban, suburban, and rural schools. Parent-initiated parental involvement demonstrated significantly positive relationships with both making AYP and staying off…

  7. Which Food Security Determinants Predict Adequate Vegetable Consumption among Rural Western Australian Children?

    PubMed

    Godrich, Stephanie L; Lo, Johnny; Davies, Christina R; Darby, Jill; Devine, Amanda

    2017-01-03

    Improving the suboptimal vegetable consumption among the majority of Australian children is imperative in reducing chronic disease risk. The objective of this research was to determine whether there was a relationship between food security determinants (FSD) (i.e., food availability, access, and utilisation dimensions) and adequate vegetable consumption among children living in regional and remote Western Australia (WA). Caregiver-child dyads (n = 256) living in non-metropolitan/rural WA completed cross-sectional surveys that included questions on FSD, demographics and usual vegetable intake. A total of 187 dyads were included in analyses, which included descriptive and logistic regression analyses via IBM SPSS (version 23). A total of 13.4% of children in this sample had adequate vegetable intake. FSD that met inclusion criteria (p ≤ 0.20) for multivariable regression analyses included price; promotion; quality; location of food outlets; variety of vegetable types; financial resources; and transport to outlets. After adjustment for potential demographic confounders, the FSD that predicted adequate vegetable consumption were, variety of vegetable types consumed (p = 0.007), promotion (p = 0.017), location of food outlets (p = 0.027), and price (p = 0.043). Food retail outlets should ensure that adequate varieties of vegetable types (i.e., fresh, frozen, tinned) are available, vegetable messages should be promoted through food retail outlets and in community settings, towns should include a range of vegetable purchasing options, increase their reliance on a local food supply and increase transport options to enable affordable vegetable purchasing.

  8. 9 CFR 2.33 - Attending veterinarian and adequate veterinary care.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... veterinary care. 2.33 Section 2.33 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE ANIMAL WELFARE REGULATIONS Research Facilities § 2.33 Attending veterinarian and adequate veterinary care. (a) Each research facility shall have an attending veterinarian who shall...

  9. 9 CFR 2.33 - Attending veterinarian and adequate veterinary care.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... veterinary care. 2.33 Section 2.33 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE ANIMAL WELFARE REGULATIONS Research Facilities § 2.33 Attending veterinarian and adequate veterinary care. (a) Each research facility shall have an attending veterinarian who shall...

  10. Identifying the Factors Impacting the Adequately Yearly Progress Performance in the United States

    ERIC Educational Resources Information Center

    Hsieh, Ju-Shan

    2013-01-01

    The NCLB (No Child Left Behind Act) specifies that states must develop AYP (adequate yearly progress) statewide measurable objectives for improved achievement by all students, including economically disadvantaged students, students from minority races, students with disabilities, and students with limited English proficiency. By the 2013-2014…

  11. 42 CFR 438.207 - Assurances of adequate capacity and services.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Assurances of adequate capacity and services. 438.207 Section 438.207 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS MANAGED CARE Quality Assessment and...

  12. 36 CFR 13.960 - Who determines when there is adequate snow cover?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 36 Parks, Forests, and Public Property 1 2011-07-01 2011-07-01 false Who determines when there is adequate snow cover? 13.960 Section 13.960 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park...

  13. 36 CFR 13.960 - Who determines when there is adequate snow cover?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 1 2010-07-01 2010-07-01 false Who determines when there is adequate snow cover? 13.960 Section 13.960 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park...

  14. 76 FR 51041 - Hemoglobin Standards and Maintaining Adequate Iron Stores in Blood Donors; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... HUMAN SERVICES Food and Drug Administration Hemoglobin Standards and Maintaining Adequate Iron Stores in... workshop. The Food and Drug Administration (FDA) is announcing a public workshop entitled: ``Hemoglobin... discuss blood donor hemoglobin and hematocrit qualification standards in the United States, its impact...

  15. 21 CFR 514.117 - Adequate and well-controlled studies.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... adequate and well-controlled studies of a new animal drug is to distinguish the effect of the new animal... with one or more controls to provide a quantitative evaluation of drug effects. The protocol and the... for special circumstances. Examples include studies in which the effect of the new animal drug is...

  16. 21 CFR 514.117 - Adequate and well-controlled studies.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... adequate and well-controlled studies of a new animal drug is to distinguish the effect of the new animal... with one or more controls to provide a quantitative evaluation of drug effects. The protocol and the... for special circumstances. Examples include studies in which the effect of the new animal drug is...

  17. 21 CFR 514.117 - Adequate and well-controlled studies.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... adequate and well-controlled studies of a new animal drug is to distinguish the effect of the new animal... with one or more controls to provide a quantitative evaluation of drug effects. The protocol and the... for special circumstances. Examples include studies in which the effect of the new animal drug is...

  18. 21 CFR 514.117 - Adequate and well-controlled studies.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... adequate and well-controlled studies of a new animal drug is to distinguish the effect of the new animal... with one or more controls to provide a quantitative evaluation of drug effects. The protocol and the... for special circumstances. Examples include studies in which the effect of the new animal drug is...

  19. 21 CFR 514.117 - Adequate and well-controlled studies.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... adequate and well-controlled studies of a new animal drug is to distinguish the effect of the new animal... with one or more controls to provide a quantitative evaluation of drug effects. The protocol and the... for special circumstances. Examples include studies in which the effect of the new animal drug is...

  20. 30 CFR 227.801 - What if a State does not adequately perform a delegated function?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... delegated function? 227.801 Section 227.801 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF THE INTERIOR MINERALS REVENUE MANAGEMENT DELEGATION TO STATES Performance Review § 227.801 What if a State does not adequately perform a delegated function? If your performance of the delegated function does...

  1. Science Education as a Contributor to Adequate Yearly Progress and Accountability Programs

    ERIC Educational Resources Information Center

    Judson, Eugene

    2010-01-01

    The No Child Left Behind (NCLB) Act requires states to measure the adequate yearly progress (AYP) of each public school and local educational agency (LEA) and to hold schools and LEAs accountable for failing to make AYP. Although it is required that science be assessed in at least three grades, the achievement results from science examinations are…

  2. 42 CFR 417.568 - Adequate financial records, statistical data, and cost finding.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Adequate financial records, statistical data, and... financial records, statistical data, and cost finding. (a) Maintenance of records. (1) An HMO or CMP must maintain sufficient financial records and statistical data for proper determination of costs payable by...

  3. Understanding the pelvic pain mechanism is key to find an adequate therapeutic approach.

    PubMed

    Van Kerrebroeck, Philip

    2016-06-25

    Pain is a natural mechanism to actual or potential tissue damage and involves both a sensory and an emotional experience. In chronic pelvic pain, localisation of pain can be widespread and can cause considerable distress. A multidisciplinary approach is needed in order to fully understand the pelvic pain mechanism and to identify an adequate therapeutic approach.

  4. 36 CFR 13.960 - Who determines when there is adequate snow cover?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 36 Parks, Forests, and Public Property 1 2012-07-01 2012-07-01 false Who determines when there is adequate snow cover? 13.960 Section 13.960 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park...

  5. 36 CFR 13.960 - Who determines when there is adequate snow cover?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 36 Parks, Forests, and Public Property 1 2014-07-01 2014-07-01 false Who determines when there is adequate snow cover? 13.960 Section 13.960 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park...

  6. 36 CFR 13.960 - Who determines when there is adequate snow cover?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 36 Parks, Forests, and Public Property 1 2013-07-01 2013-07-01 false Who determines when there is adequate snow cover? 13.960 Section 13.960 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR NATIONAL PARK SYSTEM UNITS IN ALASKA Special Regulations-Denali National Park...

  7. Human milk feeding supports adequate growth in infants

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Despite current nutritional strategies, premature infants remain at high risk for extrauterine growth restriction. The use of an exclusive human milk-based diet is associated with decreased incidence of necrotizing enterocolitis (NEC), but concerns exist about infants achieving adequate growth. The ...

  8. Adequate Yearly Progress for Students with Emotional and Behavioral Disorders through Research-Based Practices

    ERIC Educational Resources Information Center

    Vannest, Kimberly J.; Temple-Harvey, Kimberly K.; Mason, Benjamin A.

    2009-01-01

    Because schools are held accountable for the academic performance of all students, it is important to focus on academics and the need for effective teaching practices. Adequate yearly progress, a method of accountability that is part of the No Child Left Behind Act (2001), profoundly affects the education of students who have emotional and…

  9. Influenza 2005-2006: vaccine supplies adequate, but bird flu looms.

    PubMed

    Mossad, Sherif B

    2005-11-01

    Influenza vaccine supplies appear to be adequate for the 2005-2006 season, though delivery has been somewhat delayed. However, in the event of a pandemic of avian flu-considered inevitable by most experts, although no one knows when it will happen-the United States would be woefully unprepared.

  10. How Much and What Kind? Identifying an Adequate Technology Infrastructure for Early Childhood Education. Policy Brief

    ERIC Educational Resources Information Center

    Daugherty, Lindsay; Dossani, Rafiq; Johnson, Erin-Elizabeth; Wright, Cameron

    2014-01-01

    To realize the potential benefits of technology use in early childhood education (ECE), and to ensure that technology can help to address the digital divide, providers, families of young children, and young children themselves must have access to an adequate technology infrastructure. The goals for technology use in ECE that a technology…

  11. Trial watch

    PubMed Central

    Vacchelli, Erika; Senovilla, Laura; Eggermont, Alexander; Fridman, Wolf Hervé; Galon, Jérôme; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

    2013-01-01

    It is now clear that the immune system plays a critical role not only during oncogenesis and tumor progression, but also as established neoplastic lesions respond to therapy. Selected cytotoxic chemicals can indeed elicit immunogenic cell death, a functionally peculiar type of apoptosis that stimulates tumor-specific cognate immune responses. Such immunogenic chemotherapeutics include cyclophosphamide, doxorubicin and oxaliplatin (which are approved by FDA for the treatment of various hematological and solid malignancies), mitoxantrone (which is currently employed both as an anticancer agent and against multiple sclerosis) and patupilone (a microtubular poison in clinical development). One year ago, in the second issue of OncoImmunology, we discussed the scientific rationale behind immunogenic chemotherapy and reviewed the status of recent clinical trials investigating the off-label use of cyclophosphamide, doxorubicin, oxaliplatin and mitoxantrone in cancer patients. Here, we summarize the latest developments in this area of clinical research, covering both high-impact studies that have been published during the last 13 months and clinical trials that have been initiated in the same period to assess the antineoplastic profile of immunogenic chemotherapeutics. PMID:23687621

  12. Trial Watch

    PubMed Central

    Vacchelli, Erika; Aranda, Fernando; Eggermont, Alexander; Galon, Jérôme; Sautès-Fridman, Catherine; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

    2014-01-01

    In 1997, for the first time in history, a monoclonal antibody (mAb), i.e., the chimeric anti-CD20 molecule rituximab, was approved by the US Food and Drug Administration for use in cancer patients. Since then, the panel of mAbs that are approved by international regulatory agencies for the treatment of hematopoietic and solid malignancies has not stopped to expand, nowadays encompassing a stunning amount of 15 distinct molecules. This therapeutic armamentarium includes mAbs that target tumor-associated antigens, as well as molecules that interfere with tumor-stroma interactions or exert direct immunostimulatory effects. These three classes of mAbs exert antineoplastic activity via distinct mechanisms, which may or may not involve immune effectors other than the mAbs themselves. In previous issues of OncoImmunology, we provided a brief scientific background to the use of mAbs, all types confounded, in cancer therapy, and discussed the results of recent clinical trials investigating the safety and efficacy of this approach. Here, we focus on mAbs that primarily target malignant cells or their interactions with stromal components, as opposed to mAbs that mediate antineoplastic effects by activating the immune system. In particular, we discuss relevant clinical findings that have been published during the last 13 months as well as clinical trials that have been launched in the same period to investigate the therapeutic profile of hitherto investigational tumor-targeting mAbs. PMID:24605265

  13. Trial Watch

    PubMed Central

    Aranda, Fernando; Vacchelli, Erika; Eggermont, Alexander; Galon, Jerome; Fridman, Wolf Hervé; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

    2014-01-01

    Immunostimulatory monoclonal antibodies (mAbs) exert antineoplastic effects by eliciting a novel or reinstating a pre-existing antitumor immune response. Most often, immunostimulatory mAbs activate T lymphocytes or natural killer (NK) cells by inhibiting immunosuppressive receptors, such as cytotoxic T lymphocyte-associated protein 4 (CTLA4) or programmed cell death 1 (PDCD1, best known as PD-1), or by engaging co-stimulatory receptors, like CD40, tumor necrosis factor receptor superfamily, member 4 (TNFRSF4, best known as OX40) or TNFRSF18 (best known as GITR). The CTLA4-targeting mAb ipilimumab has been approved by the US Food and Drug Administration for use in patients with unresectable or metastatic melanoma in 2011. The therapeutic profile of ipilimumab other CTLA4-blocking mAbs, such as tremelimumab, is currently being assessed in subjects affected by a large panel of solid neoplasms. In the last few years, promising clinical results have also been obtained with nivolumab, a PD-1-targeting mAb formerly known as BMS-936558. Accordingly, the safety and efficacy of nivolumab and other PD-1-blocking molecules are being actively investigated. Finally, various clinical trials are underway to test the therapeutic potential of OX40- and GITR-activating mAbs. Here, we summarize recent findings on the therapeutic profile of immunostimulatory mAbs and discuss clinical trials that have been launched in the last 14 months to assess the therapeutic profile of these immunotherapeutic agents. PMID:24701370

  14. Trial Watch

    PubMed Central

    Aranda, Fernando; Vacchelli, Erika; Obrist, Florine; Eggermont, Alexander; Galon, Jérôme; Sautès-Fridman, Catherine; Cremer, Isabelle; Henrik ter Meulen, Jan; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

    2014-01-01

    Toll-like receptors (TLRs) are an evolutionarily conserved group of enzymatically inactive, single membrane-spanning proteins that recognize a wide panel of exogenous and endogenous danger signals. Besides constituting a crucial component of the innate immune response to bacterial and viral pathogens, TLRs appear to play a major role in anticancer immunosurveillance. In line with this notion, several natural and synthetic TLR ligands have been intensively investigated for their ability to boost tumor-targeting immune responses elicited by a variety of immunotherapeutic and chemotherapeutic interventions. Three of these agents are currently approved by the US Food and Drug Administration (FDA) or equivalent regulatory agencies for use in cancer patients: the so-called bacillus Calmette-Guérin, monophosphoryl lipid A, and imiquimod. However, the number of clinical trials testing the therapeutic potential of both FDA-approved and experimental TLR agonists in cancer patients is stably decreasing, suggesting that drug developers and oncologists are refocusing their interest on alternative immunostimulatory agents. Here, we summarize recent findings on the use of TLR agonists in cancer patients and discuss how the clinical evaluation of FDA-approved and experimental TLR ligands has evolved since the publication of our first Trial Watch dealing with this topic. PMID:25083332

  15. Trial watch

    PubMed Central

    Vacchelli, Erika; Vitale, Ilio; Eggermont, Alexander; Fridman, Wolf Hervé; Fučíková, Jitka; Cremer, Isabelle; Galon, Jérôme; Tartour, Eric; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

    2013-01-01

    Dendritic cells (DCs) occupy a privileged position at the interface between innate and adaptive immunity, orchestrating a large panel of responses to both physiological and pathological cues. In particular, whereas the presentation of antigens by immature DCs generally results in the development of immunological tolerance, mature DCs are capable of priming robust, and hence therapeutically relevant, adaptive immune responses. In line with this notion, functional defects in the DC compartment have been shown to etiologically contribute to pathological conditions including (but perhaps not limited to) infectious diseases, allergic and autoimmune disorders, graft rejection and cancer. Thus, the possibility of harnessing the elevated immunological potential of DCs for anticancer therapy has attracted considerable interest from both researchers and clinicians over the last decade. Alongside, several methods have been developed not only to isolate DCs from cancer patients, expand them, load them with tumor-associated antigens and hence generate highly immunogenic clinical grade infusion products, but also to directly target DCs in vivo. This intense experimental effort has culminated in 2010 with the approval by the US FDA of a DC-based preparation (sipuleucel-T, Provenge®) for the treatment of asymptomatic or minimally symptomatic metastatic castration-refractory prostate cancer. As an update to the latest Trial Watch dealing with this exciting field of research (October 2012), here we summarize recent advances in DC-based anticancer regimens, covering both high-impact studies that have been published during the last 13 mo and clinical trials that have been launched in the same period to assess the antineoplastic potential of this variant of cellular immunotherapy. PMID:24286020

  16. Trial watch

    PubMed Central

    Senovilla, Laura; Vacchelli, Erika; Garcia, Pauline; Eggermont, Alexander; Fridman, Wolf Hervé; Galon, Jérôme; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

    2013-01-01

    The foundation of modern vaccinology dates back to the 1790s, when the English physician Edward Jenner uncovered the tremendous medical potential of prophylactic vaccination. Jenner’s work ignited a wave of nationwide vaccination campaigns abating the incidence of multiple life-threatening infectious diseases and culminating with the eradication of natural smallpox virus, which was definitively certified by the WHO in 1980. The possibility of using vaccines against cancer was first proposed at the end of the 19th century by Paul Ehrlich and William Coley. However, it was not until the 1990s that such a hypothesis began to be intensively investigated, following the realization that the immune system is not completely unresponsive to tumors and that neoplastic cells express immunogenic tumor-associated antigens (TAAs). Nowadays, anticancer vaccines are rapidly moving from the bench to the bedside, and a few prophylactic and therapeutic preparations have already been approved by FDA for use in humans. In this setting, one interesting approach is constituted by DNA vaccines, i.e., TAA-encoding circularized DNA constructs, often of bacterial origin, that are delivered to patients as such or by means of specific vectors, including (but not limited to) liposomal preparations, nanoparticles, bacteria and viruses. The administration of DNA vaccines is most often performed via the intramuscular or subcutaneous route and is expected to cause (1) the endogenous synthesis of the TAA by myocytes and/or resident antigen-presenting cells; (2) the presentation of TAA-derived peptides on the cell surface, in association with MHC class I molecules; and (3) the activation of potentially therapeutic tumor-specific immune responses. In this Trial Watch, we will summarize the results of recent clinical trials that have evaluated/are evaluating DNA vaccines as therapeutic interventions against cancer. PMID:23734328

  17. The concept of adequate causation and Max Weber's comparative sociology of religion.

    PubMed

    Buss, A

    1999-06-01

    Max Weber's The Protestant Ethic and the Spirit of Capitalism, studied in isolation, shows mainly an elective affinity or an adequacy on the level of meaning between the Protestant ethic and the 'spirit' of capitalism. Here it is suggested that Weber's subsequent essays on 'The Economic Ethics of World Religions' are the result of his opinion that adequacy on the level of meaning needs and can be verified by causal adequacy. After some introductory remarks, particularly on elective affinity, the paper tries to develop the concept of adequate causation and the related concept of objective possibility on the basis of the work of v. Kries on whom Weber heavily relied. In the second part, this concept is used to show how the study of the economic ethics of India, China, Rome and orthodox Russia can support the thesis that the 'spirit' of capitalism, although it may not have been caused by the Protestant ethic, was perhaps adequately caused by it.

  18. Ensuring smokers are adequately informed: reflections on consumer rights, manufacturer responsibilities, and policy implications

    PubMed Central

    Chapman, S; Liberman, J

    2005-01-01

    The right to information is a fundamental consumer value. Following the advent of health warnings, the tobacco industry has repeatedly asserted that smokers are fully informed of the risks they take, while evidence demonstrates widespread superficial levels of awareness and understanding. There remains much that tobacco companies could do to fulfil their responsibilities to inform smokers. We explore issues involved in the meaning of "adequately informed" smoking and discuss some of the key policy and regulatory implications. We use the idea of a smoker licensing scheme—under which it would be illegal to sell to smokers who had not demonstrated an adequate level of awareness—as a device to explore some of these issues. We also explore some of the difficulties that addiction poses for the notion that smokers might ever voluntarily assume the risks of smoking. PMID:16046703

  19. Justifying clinical trials for porcine islet xenotransplantation.

    PubMed

    Ellis, Cara E; Korbutt, Gregory S

    2015-01-01

    The development of the Edmonton Protocol encouraged a great deal of optimism that a cell-based cure for type I diabetes could be achieved. However, donor organ shortages prevent islet transplantation from being a widespread solution as the supply cannot possibly equal the demand. Porcine islet xenotransplantation has the potential to address these shortages, and recent preclinical and clinical trials show promising scientific support. Consequently, it is important to consider whether the current science meets the ethical requirements for moving toward clinical trials. Despite the potential risks and the scientific unknowns that remain to be investigated, there is optimism regarding the xenotransplantation of some types of tissue, and enough evidence has been gathered to ethically justify clinical trials for the most safe and advanced area of research, porcine islet transplantation. Researchers must make a concerted effort to maintain a positive image for xenotransplantation, as a few well-publicized failed trials could irrevocably damage public perception of xenotransplantation. Because all of society carries the burden of risk, it is important that the public be involved in the decision to proceed. As new information from preclinical and clinical trials develops, policy decisions should be frequently updated. If at any point evidence shows that islet xenotransplantation is unsafe, then clinical trials will no longer be justified and they should be halted. However, as of now, the expected benefit of an unlimited supply of islets, combined with adequate informed consent, justifies clinical trials for islet xenotransplantation.

  20. Myth 19: Is Advanced Placement an Adequate Program for Gifted Students?

    ERIC Educational Resources Information Center

    Gallagher, Shelagh A.

    2009-01-01

    Is it a myth that Advanced Placement (AP) is an adequate program for gifted students? AP is so covered with myths and assumptions that it is hard to get a clear view of the issues. In this article, the author finds the answer about AP by looking at current realties. First, AP is hard for gifted students to avoid. Second, AP never was a program…

  1. Which Food Security Determinants Predict Adequate Vegetable Consumption among Rural Western Australian Children?

    PubMed Central

    Godrich, Stephanie L.; Lo, Johnny; Davies, Christina R.; Darby, Jill; Devine, Amanda

    2017-01-01

    Improving the suboptimal vegetable consumption among the majority of Australian children is imperative in reducing chronic disease risk. The objective of this research was to determine whether there was a relationship between food security determinants (FSD) (i.e., food availability, access, and utilisation dimensions) and adequate vegetable consumption among children living in regional and remote Western Australia (WA). Caregiver-child dyads (n = 256) living in non-metropolitan/rural WA completed cross-sectional surveys that included questions on FSD, demographics and usual vegetable intake. A total of 187 dyads were included in analyses, which included descriptive and logistic regression analyses via IBM SPSS (version 23). A total of 13.4% of children in this sample had adequate vegetable intake. FSD that met inclusion criteria (p ≤ 0.20) for multivariable regression analyses included price; promotion; quality; location of food outlets; variety of vegetable types; financial resources; and transport to outlets. After adjustment for potential demographic confounders, the FSD that predicted adequate vegetable consumption were, variety of vegetable types consumed (p = 0.007), promotion (p = 0.017), location of food outlets (p = 0.027), and price (p = 0.043). Food retail outlets should ensure that adequate varieties of vegetable types (i.e., fresh, frozen, tinned) are available, vegetable messages should be promoted through food retail outlets and in community settings, towns should include a range of vegetable purchasing options, increase their reliance on a local food supply and increase transport options to enable affordable vegetable purchasing. PMID:28054955

  2. Global risk assessment of aflatoxins in maize and peanuts: are regulatory standards adequately protective?

    PubMed

    Wu, Felicia; Stacy, Shaina L; Kensler, Thomas W

    2013-09-01

    The aflatoxins are a group of fungal metabolites that contaminate a variety of staple crops, including maize and peanuts, and cause an array of acute and chronic human health effects. Aflatoxin B1 in particular is a potent liver carcinogen, and hepatocellular carcinoma (HCC) risk is multiplicatively higher for individuals exposed to both aflatoxin and chronic infection with hepatitis B virus (HBV). In this work, we sought to answer the question: do current aflatoxin regulatory standards around the world adequately protect human health? Depending upon the level of protection desired, the answer to this question varies. Currently, most nations have a maximum tolerable level of total aflatoxins in maize and peanuts ranging from 4 to 20ng/g. If the level of protection desired is that aflatoxin exposures would not increase lifetime HCC risk by more than 1 in 100,000 cases in the population, then most current regulatory standards are not adequately protective even if enforced, especially in low-income countries where large amounts of maize and peanuts are consumed and HBV prevalence is high. At the protection level of 1 in 10,000 lifetime HCC cases in the population, however, almost all aflatoxin regulations worldwide are adequately protective, with the exception of several nations in Africa and Latin America.

  3. Global Risk Assessment of Aflatoxins in Maize and Peanuts: Are Regulatory Standards Adequately Protective?

    PubMed Central

    Wu, Felicia

    2013-01-01

    The aflatoxins are a group of fungal metabolites that contaminate a variety of staple crops, including maize and peanuts, and cause an array of acute and chronic human health effects. Aflatoxin B1 in particular is a potent liver carcinogen, and hepatocellular carcinoma (HCC) risk is multiplicatively higher for individuals exposed to both aflatoxin and chronic infection with hepatitis B virus (HBV). In this work, we sought to answer the question: do current aflatoxin regulatory standards around the world adequately protect human health? Depending upon the level of protection desired, the answer to this question varies. Currently, most nations have a maximum tolerable level of total aflatoxins in maize and peanuts ranging from 4 to 20ng/g. If the level of protection desired is that aflatoxin exposures would not increase lifetime HCC risk by more than 1 in 100,000 cases in the population, then most current regulatory standards are not adequately protective even if enforced, especially in low-income countries where large amounts of maize and peanuts are consumed and HBV prevalence is high. At the protection level of 1 in 10,000 lifetime HCC cases in the population, however, almost all aflatoxin regulations worldwide are adequately protective, with the exception of several nations in Africa and Latin America. PMID:23761295

  4. Current strategies for the restoration of adequate lordosis during lumbar fusion.

    PubMed

    Barrey, Cédric; Darnis, Alice

    2015-01-18

    Not restoring the adequate lumbar lordosis during lumbar fusion surgery may result in mechanical low back pain, sagittal unbalance and adjacent segment degeneration. The objective of this work is to describe the current strategies and concepts for restoration of adequate lordosis during fusion surgery. Theoretical lordosis can be evaluated from the measurement of the pelvic incidence and from the analysis of spatial organization of the lumbar spine with 2/3 of the lordosis given by the L4-S1 segment and 85% by the L3-S1 segment. Technical aspects involve patient positioning on the operating table, release maneuvers, type of instrumentation used (rod, screw-rod connection, interbody cages), surgical sequence and the overall surgical strategy. Spinal osteotomies may be required in case of fixed kyphotic spine. AP combined surgery is particularly efficient in restoring lordosis at L5-S1 level and should be recommended. Finally, not one but several strategies may be used to achieve the need for restoration of adequate lordosis during fusion surgery.

  5. Oil & gas in the 1990`s and beyond: Adequate supplies, growing demand, flat prices

    SciTech Connect

    Kennedy, J.L.

    1995-06-01

    Long term petroleum market fundamentals are clear: supplies are adequate and world demand will continue to grow steadily. Adequate supplies insure that prices will not increase significantly, on average, till the end of the 1990`s, probably much beyond. Despite plentiful supply and modest price increases, there will be peaks and valleys in the price graph as productive capacity is used up, then expanded. Tens of billions of dollars will be needed over the next decade to expand producing capacity. World oil consumption will increase at about 1.5% per year, at least for the next decade. Demand in Asia and Latin America will grow several times faster than this average world rate. World natural gas demand will grow at more then 2% per year well past 2000. Oil and gas companies around the world have changed the way they operate to survive the market realities of the 1990`s. restructuring, outsourcing, and partnering will continue as increasing costs and flat prices squeeze profits. Energy use patterns will change. Fuel and other product specifications will change. Market shares of oil and gas will shift. But opportunities abound in this new market environment. Growing markets always provide opportunities. Technology has helped operators dramatically lower finding, developing, and producing costs. The petroleum age is far from being over. Growing markets, adequate supply, affordable products, and a 60% market share. Those are the signs of an industry with a bright future.

  6. Current strategies for the restoration of adequate lordosis during lumbar fusion

    PubMed Central

    Barrey, Cédric; Darnis, Alice

    2015-01-01

    Not restoring the adequate lumbar lordosis during lumbar fusion surgery may result in mechanical low back pain, sagittal unbalance and adjacent segment degeneration. The objective of this work is to describe the current strategies and concepts for restoration of adequate lordosis during fusion surgery. Theoretical lordosis can be evaluated from the measurement of the pelvic incidence and from the analysis of spatial organization of the lumbar spine with 2/3 of the lordosis given by the L4-S1 segment and 85% by the L3-S1 segment. Technical aspects involve patient positioning on the operating table, release maneuvers, type of instrumentation used (rod, screw-rod connection, interbody cages), surgical sequence and the overall surgical strategy. Spinal osteotomies may be required in case of fixed kyphotic spine. AP combined surgery is particularly efficient in restoring lordosis at L5-S1 level and should be recommended. Finally, not one but several strategies may be used to achieve the need for restoration of adequate lordosis during fusion surgery. PMID:25621216

  7. A test for adequate wastewater treatment based on glutathione S transferase isoenzyme profile.

    PubMed

    Grammou, A; Samaras, P; Papadimitriou, C; Papadopoulos, A I

    2013-04-01

    Discharge to the environment of treated or non-treated municipal wastewater imposes several threats to coastal and estuarine ecosystems which are difficult to assess. In our study we evaluate the use of the isoenzyme profile of glutathione S transferase (GST) in combination with the kinetic characteristics of the whole enzyme and of heme peroxidase, as a test of adequate treatment of municipal wastewater. For this reason, Artemia nauplii were incubated in artificial seawater prepared by wastewater samples, such as secondary municipal effluents produced by a conventional activated sludge unit and advanced treated effluents produced by the employment of coagulation, activated carbon adsorption and chlorination as single processes or as combined ones. Characteristic changes of the isoenzyme pattern and the enzymes' kinetic properties were caused by chlorinated secondary municipal effluent or by secondary non-chlorinated effluent. Advanced treatment by combination of coagulation and/or carbon adsorption resulted to less prominent changes, suggesting more adequate treatment. Our results suggest that GST isoenzyme profile in combination with the kinetic properties of the total enzyme family is a sensitive test for the evaluation of the adequateness of the treatment of reclaimed wastewater and the reduction of potentially harmful compounds. Potentially, it may offer a 'fingerprint' characteristic of a particular effluent and probably of the treatment level it has been subjected.

  8. Design of Sequentially Randomized Trials for Testing Adaptive Treatment Strategies

    PubMed Central

    Ogbagaber, Semhar B.; Karp, Jordan; Wahed, Abdus S.

    2016-01-01

    An adaptive treatment strategy (ATS) is an outcome-guided algorithm that allows personalized treatment of complex diseases based on patients’ disease status and treatment history. Conditions such as AIDS, depression, and cancer usually require several stages of treatment due to the chronic, multifactorial nature of illness progression and management. Sequential multiple assignment randomized (SMAR) designs permit simultaneous inference about multiple ATSs, where patients are sequentially randomized to treatments at different stages depending upon response status. The purpose of the article is to develop a sample size formula to ensure adequate power for comparing two or more ATSs. Based on a Wald-type statistic for comparing multiple ATSs with a continuous endpoint, we develop a sample size formula and test it through simulation studies. We show via simulation that the proposed sample size formula maintains the nominal power. The proposed sample size formula is not applicable to designs with time-to-event endpoints but the formula will be useful for practitioners while designing SMAR trials to compare adaptive treatment strategies. PMID:26412033

  9. Legislation for trial registration and data transparency.

    PubMed

    Bian, Zhao-Xiang; Wu, Tai-Xiang

    2010-05-26

    Public confidence in clinical trials has been eroded by data suppression, misrepresentation and manipulation. Although various attempts have been made to achieve universal trial registration- e.g., Declaration of Helsinki, WHO clinical Trial Registry Platform (WHO ICTRP), the International Committee of Medical Journal Editors requirement- they have not succeeded, probably because they lack the enough power of enforcement.Legislation appears to be the most efficient and effective means to ensure that all researchers register their trials and disseminate their data accurately and in a timely manner. We propose that a global network be established. This could be accomplished in two steps. The first step is to legislate about trial registration and data transparency, such as USA's FDAAA Act 2007; and the second step to establish a global network to ensure uniform, international consistency in policy and enforcement of trial registration and data transparency.

  10. Optimal design of clinical trials with computer simulation based on results of earlier trials, illustrated with a lipodystrophy trial in HIV patients.

    PubMed

    Abbas, Ismail; Rovira, Joan; Casanovas, Josep; Greenfield, Tony

    2008-12-01

    The designer of a clinical trial needs to make many assumptions about real-life practice based on prior knowledge. Simulation allows us to learn from experience by using the information obtained from a trial to improve the original estimators of population parameters. We propose using data from a previous trial to formulate assumptions that can be used to simulate trials and thus improve the design of new trials. To demonstrate our method, we used data from a real clinical trial which had been designed to evaluate cholesterol level changes as a surrogate marker for lipodystrophy in HIV patients. We were able to identify the optimal design that would have minimised the cost of a trial subject to a statistical power constraint which could then be used to design a new trial. In particular, we focused on three factors: the distribution of cholesterol levels in HIV patients, trial recruitment rates and trial dropout rates. We were able to verify our hypothesis that the total cost resulting from carrying out a clinical trial can be minimised by applying simulation models as an alternative to conventional approaches. In our findings the simulation model proved to be very intuitive and a useful method for testing the performance of investigators' assumptions and generating an optimal clinical trial design before being put into practice in the real world. In addition, we concluded that simulation models provide a more accurate determination of power than conventional approaches, thus minimising the total cost of clinical trials.

  11. Italy trials solar-thermal power plant

    NASA Astrophysics Data System (ADS)

    Cartlidge, Edwin

    2008-08-01

    It was in the Sicilian port of Syracuse that in 213 BC the Greek mathematician Archimedes was reputed to have torched an invading Roman fleet by concentrating the Sun's rays onto the enemy ships using large mirrors. Now, on a site very close to where Archimedes set up his putative solar weapon, engineers are building an array of parabolic mirrors to convert the Sun's energy into electricity. It is claimed that the technology, which uses molten salt to transfer energy to turbines, could be competitive with fossil fuels if it is deployed on a large enough scale in sunny climates.

  12. Trial watch

    PubMed Central

    Vacchelli, Erika; Eggermont, Alexander; Galon, Jérôme; Sautès-Fridman, Catherine; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

    2013-01-01

    During the past 20 years, dozens—if not hundreds—of monoclonal antibodies have been developed and characterized for their capacity to mediate antineoplastic effects, either as they activate/enhance tumor-specific immune responses, either as they interrupt cancer cell-intrinsic signal transduction cascades, either as they specifically delivery toxins to malignant cells or as they block the tumor-stroma interaction. Such an intense research effort has lead to the approval by FDA of no less than 14 distinct molecules for use in humans affected by hematological or solid malignancies. In the inaugural issue of OncoImmunology, we briefly described the scientific rationale behind the use of monoclonal antibodies in cancer therapy and discussed recent, ongoing clinical studies investigating the safety and efficacy of this approach in patients. Here, we summarize the latest developments in this exciting area of clinical research, focusing on high impact studies that have been published during the last 15 months and clinical trials launched in the same period to investigate the therapeutic profile of promising, yet hitherto investigational, monoclonal antibodies. PMID:23482847

  13. Trial Watch

    PubMed Central

    Semeraro, Michaela; Vacchelli, Erika; Eggermont, Alexander; Galon, Jerome; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

    2013-01-01

    Lenalidomide is a synthetic derivative of thalidomide currently approved by the US Food and Drug Administration for use in patients affected by multiple myeloma (in combination with dexamethasone) and low or intermediate-1 risk myelodysplastic syndromes that harbor 5q cytogenetic abnormalities. For illustrative purposes, the mechanism of action of lenalidomide can be subdivided into a cancer cell-intrinsic, a stromal, and an immunological component. Indeed, lenalidomide not only exerts direct cell cycle-arresting and pro-apoptotic effects on malignant cells, but also interferes with their physical and functional interaction with the tumor microenvironment and mediates a robust, pleiotropic immunostimulatory activity. In particular, lenalidomide has been shown to stimulate the cytotoxic functions of T lymphocytes and natural killer cells, to limit the immunosuppressive impact of regulatory T cells, and to modulate the secretion of a wide range of cytokines, including tumor necrosis factor α, interferon γ as well as interleukin (IL)-6, IL-10, and IL-12. Throughout the last decade, the antineoplastic and immunostimulatory potential of lenalidomide has been investigated in patients affected by a wide variety of hematological and solid malignancies. Here, we discuss the results of these studies and review the status of clinical trials currently assessing the safety and efficacy of this potent immunomodulatory drug in oncological indications. PMID:24482747

  14. Trial Watch

    PubMed Central

    Pol, Jonathan; Bloy, Norma; Obrist, Florine; Eggermont, Alexander; Galon, Jérôme; Hervé Fridman, Wolf; Cremer, Isabelle; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

    2014-01-01

    During the past 2 decades, the possibility that preparations capable of eliciting tumor-specific immune responses would mediate robust therapeutic effects in cancer patients has received renovated interest. In this context, several approaches to vaccinate cancer patients against their own malignancies have been conceived, including the administration of DNA constructs coding for one or more tumor-associated antigens (TAAs). Such DNA-based vaccines conceptually differ from other types of gene therapy in that they are not devised to directly kill cancer cells or sensitize them to the cytotoxic activity of a drug, but rather to elicit a tumor-specific immune response. In spite of an intense wave of preclinical development, the introduction of this immunotherapeutic paradigm into the clinical practice is facing difficulties. Indeed, while most DNA-based anticancer vaccines are well tolerated by cancer patients, they often fail to generate therapeutically relevant clinical responses. In this Trial Watch, we discuss the latest advances on the use of DNA-based vaccines in cancer therapy, discussing the literature that has been produced around this topic during the last 13 months as well as clinical studies that have been launched in the same time frame to assess the actual therapeutic potential of this intervention. PMID:24800178

  15. Trial Watch

    PubMed Central

    Bloy, Norma; Pol, Jonathan; Manic, Gwenola; Vitale, Ilio; Eggermont, Alexander; Galon, Jérôme; Tartour, Eric; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

    2014-01-01

    During the past two decades, it has become increasingly clear that the antineoplastic effects of radiation therapy do not simply reflect the ability of X-, β- and γ-rays to damage transformed cells and directly cause their permanent proliferative arrest or demise, but also involve cancer cell-extrinsic mechanisms. Indeed, among other activities, radiotherapy has been shown to favor the establishment of tumor-specific immune responses that operate systemically, underpinning the so-called ‘out-of-field’ or ‘abscopal’ effect. Thus, ionizing rays appear to elicit immunogenic cell death, a functionally peculiar variant of apoptosis associated with the emission of a particularly immunostimulatory combination of damage-associated molecular patterns. In line with this notion, radiation therapy fosters, and thus exacerbates, the antineoplastic effects of various treatment modalities, including surgery, chemotherapy and various immunotherapeutic agents. Here, we summarize recent advances in the use of ionizing rays as a means to induce or potentiate therapeutically relevant anticancer immune responses. In addition, we present clinical trials initiated during the past 12 months to test the actual benefit of radioimmunotherapy in cancer patients. PMID:25941606

  16. Trial Watch

    PubMed Central

    Vacchelli, Erika; Eggermont, Alexander; Sautès-Fridman, Catherine; Galon, Jérôme; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

    2013-01-01

    Toll-like receptors (TLRs) have long been known for their ability to initiate innate immune responses upon exposure to conserved microbial components such as lipopolysaccharide (LPS) and double-stranded RNA. More recently, this family of pattern recognition receptors has been attributed a critical role in the elicitation of anticancer immune responses, raising interest in the development of immunochemotherapeutic regimens based on natural or synthetic TLR agonists. In spite of such an intense wave of preclinical and clinical investigation, only three TLR agonists are currently licensed by FDA for use in cancer patients: bacillus Calmette–Guérin (BCG), an attenuated strain of Mycobacterium bovis that operates as a mixed TLR2/TLR4 agonist; monophosphoryl lipid A (MPL), a derivative of Salmonella minnesota that functions as a potent agonist of TLR4; and imiquimod, a synthetic imidazoquinoline that activates TLR7. One year ago, in the August and September issues of OncoImmunology, we described the main biological features of TLRs and discussed the progress of clinical studies evaluating the safety and therapeutic potential of TLR agonists in cancer patients. Here, we summarize the latest developments in this exciting area of research, focusing on preclinical studies that have been published during the last 13 mo and clinical trials launched in the same period to investigate the antineoplastic activity of TLR agonists. PMID:24083080

  17. Design and execution of clinical trials in orthopaedic surgery

    PubMed Central

    Mundi, R.; Chaudhry, H.; Mundi, S.; Godin, K.; Bhandari, M.

    2014-01-01

    High-quality randomised controlled trials (RCTs) evaluating surgical therapies are fundamental to the delivery of evidence-based orthopaedics. Orthopaedic clinical trials have unique challenges; however, when these challenges are overcome, evidence from trials can be definitive in its impact on surgical practice. In this review, we highlight several issues that pose potential challenges to orthopaedic investigators aiming to perform surgical randomised controlled trials. We begin with a discussion on trial design issues, including the ethics of sham surgery, the importance of sample size, the need for patient-important outcomes, and overcoming expertise bias. We then explore features surrounding the execution of surgical randomised trials, including ethics review boards, the importance of organisational frameworks, and obtaining adequate funding. Cite this article: Bone Joint Res 2014;3:161–8. PMID:24869465

  18. Five-year results of a randomised controlled trial comparing mobile and fixed bearings in total knee replacement.

    PubMed

    Breeman, S; Campbell, M K; Dakin, H; Fiddian, N; Fitzpatrick, R; Grant, A; Gray, A; Johnston, L; MacLennan, G S; Morris, R W; Murray, D W

    2013-04-01

    There is conflicting evidence about the merits of mobile bearings in total knee replacement, partly because most randomised controlled trials (RCTs) have not been adequately powered. We report the results of a multicentre RCT of mobile versus fixed bearings. This was part of the knee arthroplasty trial (KAT), where 539 patients were randomly allocated to mobile or fixed bearings and analysed on an intention-to-treat basis. The primary outcome measure was the Oxford Knee Score (OKS) plus secondary measures including Short Form-12, EuroQol EQ-5D, costs, cost-effectiveness and need for further surgery. There was no significant difference between the groups pre-operatively: mean OKS was 17.18 (sd 7.60) in the mobile-bearing group and 16.49 (sd 7.40) in the fixed-bearing group. At five years mean OKS was 33.19 (sd 16.68) and 33.65 (sd 9.68), respectively. There was no significant difference between trial groups in OKS at five years (-1.12 (95% confidence interval -2.77 to 0.52) or any of the other outcome measures. Furthermore, there was no significant difference in the proportion of patients with knee-related re-operations or in total costs. In this appropriately powered RCT, over the first five years after total knee replacement functional outcomes, re-operation rates and healthcare costs appear to be the same irrespective of whether a mobile or fixed bearing is used.

  19. Are the current Australian sun exposure guidelines effective in maintaining adequate levels of 25-hydroxyvitamin D?

    PubMed

    Kimlin, Michael; Sun, Jiandong; Sinclair, Craig; Heward, Sue; Hill, Jane; Dunstone, Kimberley; Brodie, Alison

    2016-01-01

    An adequate vitamin D status, as measured by serum 25-hydroxyvitamin D (25(OH)D) concentration, is important in humans for maintenance of healthy bones and muscle function. Serum 25(OH)D concentration was assessed in participants from Melbourne, Australia (37.81S, 144.96E), who were provided with the current Australian guidelines on sun exposure for 25(OH)D adequacy (25(OH)D ≥50 nmol/L). Participants were interviewed in February (summer, n=104) and August (winter, n=99) of 2013. Serum 25(OH)D concentration was examined as a function of measures of sun exposure and sun protection habits with control of key characteristics such as dietary intake of vitamin D, body mass index (BMI) and skin colour, that may modify this relationship. The mean 25(OH)D concentration in participants who complied with the current sun exposure guidelines was 67.3 nmol/L in summer and 41.9 nmol/L in winter. At the end of the study, 69.3% of participants who complied with the summer sun exposure guidelines were 25(OH)D adequate, while only 27.6% of participants who complied with the winter sun exposure guidelines were 25(OH)D adequate at the end of the study. The results suggest that the current Australian guidelines for sun exposure for 25(OH)D adequacy are effective for most in summer and ineffective for most in winter. This article is part of a Special Issue entitled '17th Vitamin D Workshop'.

  20. Adequate Iodine Status in New Zealand School Children Post-Fortification of Bread with Iodised Salt

    PubMed Central

    Jones, Emma; McLean, Rachael; Davies, Briar; Hawkins, Rochelle; Meiklejohn, Eva; Ma, Zheng Feei; Skeaff, Sheila

    2016-01-01

    Iodine deficiency re-emerged in New Zealand in the 1990s, prompting the mandatory fortification of bread with iodised salt from 2009. This study aimed to determine the iodine status of New Zealand children when the fortification of bread was well established. A cross-sectional survey of children aged 8–10 years was conducted in the cities of Auckland and Christchurch, New Zealand, from March to May 2015. Children provided a spot urine sample for the determination of urinary iodine concentration (UIC), a fingerpick blood sample for Thyroglobulin (Tg) concentration, and completed a questionnaire ascertaining socio-demographic information that also included an iodine-specific food frequency questionnaire (FFQ). The FFQ was used to estimate iodine intake from all main food sources including bread and iodised salt. The median UIC for all children (n = 415) was 116 μg/L (females 106 μg/L, males 131 μg/L) indicative of adequate iodine status according to the World Health Organisation (WHO, i.e., median UIC of 100–199 μg/L). The median Tg concentration was 8.7 μg/L, which was <10 μg/L confirming adequate iodine status. There was a significant difference in UIC by sex (p = 0.001) and ethnicity (p = 0.006). The mean iodine intake from the food-only model was 65 μg/day. Bread contributed 51% of total iodine intake in the food-only model, providing a mean iodine intake of 35 μg/day. The mean iodine intake from the food-plus-iodised salt model was 101 μg/day. In conclusion, the results of this study confirm that the iodine status in New Zealand school children is now adequate. PMID:27196925

  1. The Nigerian health care system: Need for integrating adequate medical intelligence and surveillance systems

    PubMed Central

    Welcome, Menizibeya Osain

    2011-01-01

    Objectives: As an important element of national security, public health not only functions to provide adequate and timely medical care but also track, monitor, and control disease outbreak. The Nigerian health care had suffered several infectious disease outbreaks year after year. Hence, there is need to tackle the problem. This study aims to review the state of the Nigerian health care system and to provide possible recommendations to the worsening state of health care in the country. To give up-to-date recommendations for the Nigerian health care system, this study also aims at reviewing the dynamics of health care in the United States, Britain, and Europe with regards to methods of medical intelligence/surveillance. Materials and Methods: Databases were searched for relevant literatures using the following keywords: Nigerian health care, Nigerian health care system, and Nigerian primary health care system. Additional keywords used in the search were as follows: United States (OR Europe) health care dynamics, Medical Intelligence, Medical Intelligence systems, Public health surveillance systems, Nigerian medical intelligence, Nigerian surveillance systems, and Nigerian health information system. Literatures were searched in scientific databases Pubmed and African Journals OnLine. Internet searches were based on Google and Search Nigeria. Results: Medical intelligence and surveillance represent a very useful component in the health care system and control diseases outbreak, bioattack, etc. There is increasing role of automated-based medical intelligence and surveillance systems, in addition to the traditional manual pattern of document retrieval in advanced medical setting such as those in western and European countries. Conclusion: The Nigerian health care system is poorly developed. No adequate and functional surveillance systems are developed. To achieve success in health care in this modern era, a system well grounded in routine surveillance and medical

  2. Nebulized antibiotics. An adequate option for treating ventilator-associated respiratory infection?

    PubMed

    Rodríguez, A; Barcenilla, F

    2015-03-01

    Ventilator-associated tracheobronchitis (VAT) is a frequent complication in critical patients. The 90% of those who develop it receive broad-spectrum antibiotic (ATB) treatment, without any strong evidence of its favorable impact. The use of nebulized ATB could be a valid treatment option, to reduce the use of systemic ATB and the pressure of selection on the local flora. Several studies suggest that an adequate nebulization technique can ensure high levels of ATB even in areas of lung consolidation, and to obtain clinical and microbiological cure. New studies are needed to properly assess the impact of treatment with nebulized ATB on the emergence of resistance.

  3. Computer synthesis of human motion as a part of an adequate motion analysis experiment

    NASA Astrophysics Data System (ADS)

    Ivanov, Alexandre A.; Sholukha, Victor A.; Zinkovsky, Anatoly V.

    1999-05-01

    The role of problem of computer synthesis of a human motion for a traditional problem of control generalized and muscular forces determination is discussed. It is emphasized significance of computer model choice for adequate analysis kinematic and dynamic experimental data. On the basis of an imitation computer model influence of model's parameters values is demonstrated. With help of non-stationary constraints we can simulate human motions that satisfy to the most significant parameters of the concerned class of motion. Some results of simulation are discussed. We arrive at a conclusion that for correct interpretation of an experiment mixed problem of bodies system dynamics must be solved.

  4. Trial Watch

    PubMed Central

    Aranda, Fernando; Vacchelli, Erika; Eggermont, Alexander; Galon, Jerome; Sautès-Fridman, Catherine; Tartour, Eric; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

    2013-01-01

    Throughout the past 3 decades, along with the recognition that the immune system not only influences oncogenesis and tumor progression, but also determines how established neoplastic lesions respond therapy, renovated enthusiasm has gathered around the possibility of using vaccines as anticancer agents. Such an enthusiasm quickly tempered when it became clear that anticancer vaccines would have to be devised as therapeutic, rather than prophylactic, measures, and that malignant cells often fail to elicit (or actively suppress) innate and adaptive immune responses. Nonetheless, accumulating evidence indicates that a variety of anticancer vaccines, including cell-based, DNA-based, and purified component-based preparations, are capable of circumventing the poorly immunogenic and highly immunosuppressive nature of most tumors and elicit (at least under some circumstances) therapeutically relevant immune responses. Great efforts are currently being devoted to the identification of strategies that may provide anticancer vaccines with the capacity of breaking immunological tolerance and eliciting tumor-associated antigen-specific immunity in a majority of patients. In this sense, promising results have been obtained by combining anticancer vaccines with a relatively varied panels of adjuvants, including multiple immunostimulatory cytokines, Toll-like receptor agonists as well as inhibitors of immune checkpoints. One year ago, in the December issue of OncoImmunology, we discussed the biological mechanisms that underlie the antineoplastic effects of peptide-based vaccines and presented an abundant literature demonstrating the prominent clinical potential of such an approach. Here, we review the latest developments in this exciting area of research, focusing on high-profile studies that have been published during the last 13 mo and clinical trials launched in the same period to evaluate purified peptides or full-length proteins as therapeutic anticancer agents. PMID:24498550

  5. Canadian aeronautical mobile data trials

    NASA Technical Reports Server (NTRS)

    Pedersen, Allister; Pearson, Andrea

    1993-01-01

    This paper describes a series of aeronautical mobile data trials conducted on small aircraft (helicopters and fixed wing) utilizing a low-speed store-and-forward mobile data service. The paper outlines the user requirements for aeronautical mobile satellite communications. 'Flight following' and improved wide-area dispatch communications were identified as high priority requirements. A 'proof-of-concept' trial in a Cessna Skymaster aircraft is described. This trial identified certain development work as essential to the introduction of commercial service including antenna development, power supply modifications and doppler software modifications. Other improvements were also proposed. The initial aeronautical mobile data service available for pre-operational (Beta) trials is outlined. Pre-operational field trials commenced in October 1992 and consisted of installations on a Gralen Communications Inc. Cessna 177 and an Aerospatiale Astar 350 series light single engine helicopter. The paper concludes with a discussion of desirable near term mobile data service developments, commercial benefits, current safety benefits and potential future applications for improved safety.

  6. [Incidence of primary malignant lesions in clinically benign teratoma: on the problem of adequate surgical procedure].

    PubMed

    Kindermann, G; Jung, E M; Maassen, V; Bise, K

    1996-08-01

    The Problem of an Adequate Surgical Approach: Frequency of malignant teratomas is, according to the literature, 2%-10%. Examining 194 own cases (1983-1993) it was 1.5%. We found one squamous cell carcinoma (0.5%). Additionally we found 2 immature teratomas (1%). We point out the different biological behaviour of malignant mature teratomas and immature teratomas. We agree with the majority of authors that the method of choice is the intact removal of all teratomas without iatrogen rupture or contamination of the abdominal cavity by contents of the teratoma. This adequate surgical procedure can and should be performed by laparotomy or laparoscopy with endobag. The often practised method of cutting open the cyst during laparoscopy, sucking off the contents or cutting the teratoma into pieces, has been proven to lead to implantation and worsening the prognosis in case of a malignant teratoma. Even the rinsing of the abdominal cavity, usually carried out with this method, could not compensate always for the disadvantage of this "dirty" endoscopical method compared with usual oncological standards. This is pointed out by case reports in the literature and the first analysis of a German survey with early-follow-up of 192 laparoscopically managed ovarian malignancies [11a]. The principle of intact removal of every teratoma should again be kept in mind.

  7. MRI can determine the adequate area for debridement in the case of Fournier's gangrene.

    PubMed

    Yoneda, Akira; Fujita, Fumihiko; Tokai, Hirotaka; Ito, Yuichiro; Haraguchi, Masashi; Tajima, Yoshitsugu; Kanematsu, Takashi

    2010-01-01

    A 57-year-old man was transferred to our hospital because of gluteal pain. His right buttock had flare and swelling. Complete blood count showed leukocytosis, and renal failure was evident. Pelvic computed tomography (CT) revealed that the abscess, including gas, was widespread into the hypodermal tissue of the right buttock. Fournier's gangrene had been suspected, and immediate drainage was performed on the right buttock. The symptom and the condition improved rapidly, but on the day after the operation, the patient became drowsy and fell into endotoxic shock. Magnetic resonance imaging (MRI) revealed strong inflammation along the entire fascia of the right femur and necrotizing fasciitis. MRI was very useful for identification of the necrotic range. Immediately, an emergency operation was performed; 3 wide incisions were made on the right thigh and crus for drainage. The patient was cared for intensively under a sedated condition, and irrigation and debridement were repeated every day. Culture of the pus revealed mixed infection of Escherichia coli and anaerobic bacteria, and a large quantity of antimicrobial drug was used. The inflammatory reaction decreased, and the patient's general condition tentatively improved. With Fournier's gangrene, initiating adequate surgical and medical treatment is essential. Therefore, MRI should be used in the early exact diagnosis of this disease to obtain knowledge of the extent of necrosis and to determine the adequate area for debridement.

  8. Duration of Pulmonary Tuberculosis Infectiousness under Adequate Therapy, as Assessed Using Induced Sputum Samples

    PubMed Central

    Ko, Yousang; Shin, Jeong Hwan; Lee, Hyun-Kyung; Lee, Young Seok; Lee, Suh-Young; Park, So Young; Mo, Eun-Kyung; Kim, Changhwan

    2017-01-01

    Background A sputum culture is the most reliable indicator of the infectiousness of pulmonary tuberculosis (PTB); however, a spontaneous sputum specimen may not be suitable. The aim of this study was to evaluate the infectious period in patients with non–drug-resistant (DR) PTB receiving adequate standard chemotherapy, using induced sputum (IS) specimens. Methods We evaluated the duration of infectiousness of PTB using a retrospective cohort design. Results Among the 35 patients with PTB, 22 were smear-positive. The rates of IS culture positivity from baseline to the sixth week of anti-tuberculosis medication in the smear-positive PTB group were 100%, 100%, 91%, 73%, 36%, and 18%, respectively. For smear-positive PTB cases, the median time of conversion to culture negativity was 35.0 days (range, 28.0–42.0 days). In the smear-negative PTB group (n=13), the weekly rates of positive IS culture were 100%, 77%, 39%, 8%, 0%, and 0%, respectively, and the median time to conversion to culture-negative was 21.0 days (range, 17.5–28.0 days). Conclusion The infectiousness of PTB, under adequate therapy, may persist longer than previously reported, even in patients with non-DR PTB. PMID:28119744

  9. Narita Target Heart Rate Equation Underestimates the Predicted Adequate Exercise Level in Sedentary Young Boys

    PubMed Central

    Siahkouhian, Marefat; Khodadadi, Davar

    2013-01-01

    Purpose Optimal training intensity and the adequate exercise level for physical fitness is one of the most important interests of coaches and sports physiologists. The aim of this study was to investigate the validity of the Narita et al target heart rate equation for the adequate exercise training level in sedentary young boys. Methods Forty two sedentary young boys (19.07±1.16 years) undertook a blood lactate transition threshold maximal treadmill test to volitional exhaustion with continuous respiratory gas measurements according to the Craig method. The anaerobic threshold (AT) of the participants then was calculated using the Narita target heart rate equation. Results Hopkin's spreadsheet to obtain confidence limit and the chance of the true difference between gas measurements and Narita target heart rate equation revealed that the Narita equation most likely underestimates the measured anaerobic threshold in sedentary young boys (168.76±15 vs. 130.08±14.36) (Difference ±90% confidence limit: 38.1±18). Intraclass correlation coefficient (ICC) showed a poor agreement between the criterion method and Narita equation (ICC= 0.03). Conclusion According to the results, the Narita equation underestimates the measured AT. It seems that the Narita equation is a good predictor of aerobic not AT which can be investigated in the future studies. PMID:24427475

  10. Maintaining Adequate CO2 Washout for an Advanced EMU via a New Rapid Cycle Amine Technology

    NASA Technical Reports Server (NTRS)

    Chullen, Cinda; Conger, Bruce

    2012-01-01

    Over the past several years, NASA has realized tremendous progress in Extravehicular Activity (EVA) technology development. This has been evidenced by the progressive development of a new Rapid Cycle Amine (RCA) system for the Advanced Extravehicular Mobility Unit (AEMU) Portable Life Support Subsystem (PLSS). The PLSS is responsible for the life support of the crew member in the spacesuit. The RCA technology is responsible for carbon dioxide (CO2) and humidity control. Another aspect of the RCA is that it is on-back vacuum-regenerable, efficient, and reliable. The RCA also simplifies the PLSS schematic by eliminating the need for a condensing heat exchanger for humidity control in the current EMU. As development progresses on the RCA, it is important that the sizing be optimized so that the demand on the PLSS battery is minimized. As well, maintaining the CO2 washout at adequate levels during an EVA is an absolute requirement of the RCA and associated ventilation system. Testing has been underway in-house at NASA Johnson Space Center and analysis has been initiated to evaluate whether the technology provides exemplary performance in ensuring that the CO2 is removed sufficiently and the ventilation flow is adequate for maintaining CO2 washout in the AEMU spacesuit helmet of the crew member during an EVA. This paper will review the recent developments of the RCA unit, testing planned in-house with a spacesuit simulator, and the associated analytical work along with insights from the medical aspect on the testing. 1

  11. Effect of Overhydration on Time-Trial Swim Performance.

    ERIC Educational Resources Information Center

    Maresh, Carl M.; Bergeron, Michael E.; Kenefick, Robert W.; Castellani, John W.; Hoffman, Jay R.; Armstrong, Lawrence E.

    2001-01-01

    Examined whether moderate overhydration would enhance the performance of otherwise euhydrated collegiate swimmers during two 183-meter time-trial swims held 3 days apart. Participants swam in alternate, randomized euhydrated, and overhydrated states. Results indicated that euhydration before an intense, short-duration swim was adequate for peak…

  12. How Do Clinical Trials Work?

    MedlinePlus

    ... Work Who Can Participate What To Expect During Benefits and Risks How They Protect Participants Finding Clinical Trials Links Children & Clinical Studies NHLBI Trials Clinical Trial Websites How Do Clinical Trials Work? If you take part in a clinical trial, ...

  13. 45 CFR 1159.15 - Who has the responsibility for maintaining adequate technical, physical, and security safeguards...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... disclosure or destruction of manual and automatic record systems. These security safeguards shall apply to... use of records contained in a system of records are adequately trained to protect the security and... adequate technical, physical, and security safeguards to prevent unauthorized disclosure or destruction...

  14. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not...

  15. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not...

  16. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not...

  17. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not...

  18. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not...

  19. Matching occupation and self: does matching theory adequately model children's thinking?

    PubMed

    Watson, Mark; McMahon, Mary

    2004-10-01

    The present exploratory-descriptive cross-national study focused on the career development of 11- to 14-yr.-old children, in particular whether they can match their personal characteristics with their occupational aspirations. Further, the study explored whether their matching may be explained in terms of a fit between person and environment using Holland's theory as an example. Participants included 511 South African and 372 Australian children. Findings relate to two items of the Revised Career Awareness Survey that require children to relate personal-social knowledge to their favorite occupation. Data were analyzed in three stages using descriptive statistics, i.e., mean scores, frequencies, and percentage agreement. The study indicated that children perceived their personal characteristics to be related to their occupational aspirations. However, how this matching takes place is not adequately accounted for in terms of a career theory such as that of Holland.

  20. Adequate connexin-mediated coupling is required for proper insulin production

    PubMed Central

    1995-01-01

    To assess whether connexin (Cx) expression contributes to insulin secretion, we have investigated normal and tumoral insulin-producing cells for connexins, gap junctions, and coupling. We have found that the glucose-sensitive cells of pancreatic islets and of a rat insulinoma are functionally coupled by gap junctions made of Cx43. In contrast, cells of several lines secreting insulin abnormally do not express Cx43, gap junctions, and coupling. After correction of these defects by stable transfection of Cx43 cDNA, cells expressing modest levels of Cx43 and coupling, as observed in native beta-cells, showed an expression of the insulin gene and an insulin content that were markedly elevated, compared with those observed in both wild-type (uncoupled) cells and in transfected cells overexpressing Cx43. These findings indicate that adequate levels of Cx-mediated coupling are required for proper insulin production and storage. PMID:8522612

  1. Switching off angiogenic signalling: creating channelled constructs for adequate oxygen delivery in tissue engineered constructs.

    PubMed

    Cheema, U; Alekseeva, T; Abou-Neel, E A; Brown, R A

    2010-10-06

    A major question in biomimetic tissue engineering is how much of the structure/function of native vasculature needs to be reproduced for effective tissue perfusion. O2 supplied to cells in 3D scaffolds in vitro is initially dependent upon diffusion through the scaffold and cell consumption. Low O2 (3%) enhances specific cell behaviours, but where O2 is critically low (pathological hypoxia) cell survival becomes compromised. We measured real-time O2 in 3D scaffolds and introduced micro-channelled architecture to controllably increase delivery of O2 to cells and switch off the hypoxic response. Simple static micro-channelling gives adequate perfusion and can be used to control cell generated hypoxia-induced signalling.

  2. Adaptive robust image registration approach based on adequately sampling polar transform and weighted angular projection function

    NASA Astrophysics Data System (ADS)

    Wei, Zhao; Tao, Feng; Jun, Wang

    2013-10-01

    An efficient, robust, and accurate approach is developed for image registration, which is especially suitable for large-scale change and arbitrary rotation. It is named the adequately sampling polar transform and weighted angular projection function (ASPT-WAPF). The proposed ASPT model overcomes the oversampling problem of conventional log-polar transform. Additionally, the WAPF presented as the feature descriptor is robust to the alteration in the fovea area of an image, and reduces the computational cost of the following registration process. The experimental results show two major advantages of the proposed method. First, it can register images with high accuracy even when the scale factor is up to 10 and the rotation angle is arbitrary. However, the maximum scaling estimated by the state-of-the-art algorithms is 6. Second, our algorithm is more robust to the size of the sampling region while not decreasing the accuracy of the registration.

  3. Precise femtosecond laser ablation of dental hard tissue: preliminary investigation on adequate laser parameters

    NASA Astrophysics Data System (ADS)

    Hikov, Todor; Pecheva, Emilia; Montgomery, Paul; Antoni, Frederic; Leong-Hoi, Audrey; Petrov, Todor

    2017-01-01

    This work aims at evaluating the possibility of introducing state-of-the-art commercial femtosecond laser system in restorative dentistry by maintaining well-known benefits of lasers for caries removal, but also in overcoming disadvantages such as thermal damage of irradiated substrate. Femtosecond ablation of dental hard tissue is investigated by changing the irradiation parameters (pulsed laser energy, scanning speed and pulse repetition rate), assessed for enamel and dentin. The femtosecond laser system used in this work may be suitable for cavity preparation in dentin and enamel, due to the expected effective ablation and low temperature increase when using ultra short laser pulses. If adequate laser parameters are selected, this system seems to be promising for promoting a laser-assisted, minimally invasive approach in restorative dentistry.

  4. J-modulated ADEQUATE experiments using different kinds of refocusing pulses.

    PubMed

    Thiele, Christina M; Bermel, Wolfgang

    2007-10-01

    Owing to the recent developments concerning residual dipolar couplings (RDCs), the interest in methods for the accurate determination of coupling constants is renascenting. We intended to use the J-modulated ADEQUATE experiment by Kövér et al. for the measurement of (13)C - (13)C coupling constants at natural abundance. The use of adiabatic composite chirp pulses instead of the conventional 180 degrees pulses, which compensate for the offset dependence of (13)C 180 degrees pulses, led to irregularities of the line shapes in the indirect dimension causing deviations of the extracted coupling constants. This behaviour was attributed to coupling evolution, during the time of the adiabatic pulse (2 ms), in the J-modulation spin echo. The replacement of this pulse by different kinds of refocusing pulses indicated that a pair of BIPs (broadband inversion pulses), which behave only partially adiabatic, leads to correct line shapes and coupling constants conserving the good sensitivity obtained with adiabatic pulses.

  5. A Nomogram to Predict Adequate Lymph Node Recovery before Resection of Colorectal Cancer

    PubMed Central

    Zhang, Zhen-yu; Li, Cong; Gao, Wei; Yin, Xiao-wei; Luo, Qi-feng; Liu, Nan; Basnet, Shiva; Dai, Zhen-ling; Ge, Hai-yan

    2016-01-01

    Increased lymph node count (LNC) has been associated with prolonged survival in colorectal cancer (CRC), but the underlying mechanisms are still poorly understood. The study aims to identify new predictors and develop a preoperative nomogram for predicting the probability of adequate LNC (≥ 12). 501 eligible patients were retrospectively selected to identify clinical-pathological factors associated with LNC ≥ 12 through univariate and multivariate logistic regression analyses. The nomogram was built according to multivariate analyses of preoperative factors. Model performance was assessed with concordance index (c-index) and area under the receiver operating characteristic curve (AUC), followed by internal validation and calibration using 1000-resample bootstrapping. Clinical validity of the nomogram and LNC impact on stage migration were also evaluated. Multivariate analyses showed patient age, CA19-9, circulating lymphocytes, neutrophils, platelets, tumor diameter, histology and deposit significantly correlated with LNC (P < 0.05). The effects were marginal for CEA, anemia and CRC location (0.05 < P < 0.1). The multivariate analyses of preoperative factors suggested decreased age, CEA, CA19-9, neutrophils, proximal location, and increased platelets and diameter were significantly associated with increased probability of LNC ≥ 12 (P < 0.05). The nomogram achieved c-indexes of 0.75 and 0.73 before and after correction for overfitting. The AUC was 0.75 (95% CI, 0.70–0.79) and the clinically valid threshold probabilities were between 10% and 60% for the nomogram to predict LNC < 12. Additionally, increased probability of adequate LNC before surgery was associated with increased LNC and negative lymph nodes rather than increased positive lymph nodes, lymph node ratio, pN stages or AJCC stages. Collectively, the results indicate the LNC is multifactorial and irrelevant to stage migration. The significant correlations with preoperative circulating markers may

  6. Use of Linear Programming to Develop Cost-Minimized Nutritionally Adequate Health Promoting Food Baskets

    PubMed Central

    Tetens, Inge; Dejgård Jensen, Jørgen; Smed, Sinne; Gabrijelčič Blenkuš, Mojca; Rayner, Mike; Darmon, Nicole; Robertson, Aileen

    2016-01-01

    Background Food-Based Dietary Guidelines (FBDGs) are developed to promote healthier eating patterns, but increasing food prices may make healthy eating less affordable. The aim of this study was to design a range of cost-minimized nutritionally adequate health-promoting food baskets (FBs) that help prevent both micronutrient inadequacy and diet-related non-communicable diseases at lowest cost. Methods Average prices for 312 foods were collected within the Greater Copenhagen area. The cost and nutrient content of five different cost-minimized FBs for a family of four were calculated per day using linear programming. The FBs were defined using five different constraints: cultural acceptability (CA), or dietary guidelines (DG), or nutrient recommendations (N), or cultural acceptability and nutrient recommendations (CAN), or dietary guidelines and nutrient recommendations (DGN). The variety and number of foods in each of the resulting five baskets was increased through limiting the relative share of individual foods. Results The one-day version of N contained only 12 foods at the minimum cost of DKK 27 (€ 3.6). The CA, DG, and DGN were about twice of this and the CAN cost ~DKK 81 (€ 10.8). The baskets with the greater variety of foods contained from 70 (CAN) to 134 (DGN) foods and cost between DKK 60 (€ 8.1, N) and DKK 125 (€ 16.8, DGN). Ensuring that the food baskets cover both dietary guidelines and nutrient recommendations doubled the cost while cultural acceptability (CAN) tripled it. Conclusion Use of linear programming facilitates the generation of low-cost food baskets that are nutritionally adequate, health promoting, and culturally acceptable. PMID:27760131

  7. [Quality of Mesorectal Excision ("Plane of Surgery") - Which Quality Targets are Adequate?].

    PubMed

    Hermanek, P; Merkel, S; Ptok, H; Hohenberger, W

    2015-12-01

    Today, the examination of rectal cancer specimens includes the obligate macroscopic assessment of the quality of mesorectal excision by the pathologist reporting the plane of surgery. The frequency of operations in the muscularis propria plane of surgery (earlier described as incomplete mesorectal excision) is essential. The quality of mesorectal excision is important for the prognosis, especially as local recurrences are observed more frequently after operations in the muscularis propria plane of surgery. For the definition of quality targets, data of 13 studies published between 2006 and 2012, each with more than 100 patients and adequate specialisation and experience of the surgeons (5413 patients), data of the prospective multicentric observation study "Quality Assurance - Rectal Cancer" (at the Institute for Quality Assurance in Operative Medicine at the Otto-von-Guericke University at Magdeburg) from 2005 to 2010 (8044 patients) and data of the Department of Surgery, University Hospital Erlangen, from 1998 to 2011 (991 patients) were analysed. The total incidence of operations in the muscularis propria plane of surgery was 5.0 % (721/14 448). Even with adequate specialisation and experience of the surgeon, the frequency of operations in the muscularis propria plane of surgery is higher in abdominoperineal excisions than in sphincter-preserving surgery (8.4 vs. 2.8 %, p < 0.001). Thus, the quality target for the frequency of operations in the muscularis propria plane should be defined as < 5 % for sphincter-preserving procedures and as < 10 % for abdominoperineal excisions.

  8. Maintaining Adequate CO2 Washout for an Advanced EMU via a New Rapid Cycle Amine Technology

    NASA Technical Reports Server (NTRS)

    Chullen, Cinda

    2011-01-01

    Over the past several years, NASA has realized tremendous progress in Extravehicular Activity (EVA) technology development. This has been evidenced by the progressive development of a new Rapic Cycle Amine (RCA) system for the Advanced Extravehicular Mobility Unit (AEMU) Portable Life Support Subsystem (PLSS). The PLSS is responsible for the life support of the crew member in the spacesuit. The RCA technology is responsible for carbon dioxide (CO2) and humidity control. Another aspect of the RCA is that it is on-back vacuum-regenerable, efficient, and reliable. The RCA also simplifies the PLSS schematic by eliminating the need for a condensing heat exchanger for humidity control in the current EMU. As development progresses on the RCA, it is important that the sizing be optimized so that the demand on the PLSS battery is minimized. As well, maintaining the CO2 washout at adequate levels during an EVA is an absolute requirement of the RCA and associated ventilation system. Testing has been underway in-house at NASA Johnson Space Center and analysis has been initiated to evaluate whether the technology provides exemplary performance in ensuring that the CO2 is removed sufficiently enough and the ventilation flow is adequate enough to maintain CO2 1 Project Engineer, Space Suit and Crew Survival Systems Branch, Crew and Thermal Systems Division, 2101 NASA Parkway, Houston, TX 77058/EC5. washout in the AEMU spacesuit helmet of the crew member during an EVA. This paper will review the recent developments of the RCA unit, the testing results performed in-house with a spacesuit simulator, and the associated analytical work along with insights from the medical aspect on the testing.

  9. Residual triose phosphate isomerase activity and color measurements to determine adequate cooking of ground beef patties.

    PubMed

    Sair, A I; Booren, A M; Berry, B W; Smith, D M

    1999-02-01

    The objectives were to (i) compare the use of triose phosphate isomerase (TPI) activity and internal color scores for determination of cooking adequacy of beef patties and (ii) determine the effect of frozen storage and fat content on residual TPI activity in ground beef. Ground beef patties (24.4% fat) were cooked to five temperatures ranging from 60.0 to 82.2 degrees C. TPI activity decreased as beef patty cooking temperature was increased from 60.0 to 71.1 degrees C; however, no difference (P > 0.05) in activity (6.3 U/kg meat) was observed in patties cooked to 71.1 degrees C and above. Degree of doneness color scores, a* values and b* values, of ground beef patties decreased as internal temperature was increased from 60.0 to 71.1 degrees C; however, temperature had no effect on L* values. TPI activity in raw ground beef after five freeze-thaw cycles did not differ from the control. Three freeze-thaw cycles of raw ground beef resulted in a 57.2% decrease in TPI activity after cooking. TPI activity of cooked beef increased during 2 months of frozen storage, but TPI activity in ground beef stored for 3 months or longer did not differ from the unfrozen control. While past research has shown color to be a poor indicator of adequate thermal processing, our results suggest that undercooked ground beef patties could be distinguished from those that had been adequately cooked following U.S. Department of Agriculture guidelines using residual TPI activity as a marker.

  10. Options for Affordable Fission Surface Power Systems

    NASA Technical Reports Server (NTRS)

    Houts, Mike; Gaddis, Steve; Porter, Ron; VanDyke, Melissa; Martin Jim; Godfroy, Tom; Bragg-Sitton, Shannon; Garber, Anne; Pearson, Boise

    2006-01-01

    Fission surface power systems could provide abundant power anywhere on free surface of the moon or Mars. Locations could include permanently shaded regions on the moon and high latitudes on Mars. To be fully utilized; however, fission surface power systems must be safe, have adequate performance, and be affordable. This paper discusses options for the design and development of such systems.

  11. Clinical trials of homoeopathy.

    PubMed Central

    Kleijnen, J; Knipschild, P; ter Riet, G

    1991-01-01

    OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURES--Results of the trials with the best methodological quality. Trials of classical homoeopathy and several modern varieties were considered separately. RESULTS--In 14 trials some form of classical homoeopathy was tested and in 58 trials the same single homoeopathic treatment was given to patients with comparable conventional diagnosis. Combinations of several homoeopathic treatments were tested in 26 trials; isopathy was tested in nine trials. Most trials seemed to be of very low quality, but there were many exceptions. The results showed a positive trend regardless of the quality of the trial or the variety of homeopathy used. Overall, of the 105 trials with interpretable results, 81 trials indicated positive results whereas in 24 trials no positive effects of homoeopathy were found. The results of the review may be complicated by publication bias, especially in such a controversial subject as homoeopathy. CONCLUSIONS--At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials. PMID:1825800

  12. Representation of American blacks in clinical trials of new drugs.

    PubMed

    Svensson, C K

    1989-01-13

    Investigations that have revealed racial differences in drug response and disposition indicate the need for adequate representation of racial minorities in clinical drug trials. There is concern, however, that there may be a disproportionate use of racial and ethnic minorities in clinical research due to the inner city location of most university hospitals. To examine this issue, we reviewed the representation of American blacks in 50 recently published clinical trials of new drugs. This survey revealed that investigators do not seem to adequately take into account racial differences as a potential source of variability. It also was found that in the majority of studies, the proportion of black subjects is less than their proportion in the general population. This underrepresentation in clinical trials suggests that insufficient data exist to accurately assess the safety and efficacy of many new drugs in American blacks.

  13. Study protocol for a randomised controlled trial of electronic cigarettes versus nicotine patch for smoking cessation

    PubMed Central

    2013-01-01

    Background Electronic cigarettes (e-cigarettes or electronic nicotine delivery systems [ENDS]) are electrically powered devices generally similar in appearance to a cigarette that deliver a propylene glycol and/or glycerol mist to the airway of users when drawing on the mouthpiece. Nicotine and other substances such as flavourings may be included in the fluid vaporised by the device. People report using e-cigarettes to help quit smoking and studies of their effects on tobacco withdrawal and craving suggest good potential as smoking cessation aids. However, to date there have been no adequately powered randomised trials investigating their cessation efficacy or safety. This paper outlines the protocol for this study. Methods/design Design: Parallel group, 3-arm, randomised controlled trial. Participants: People aged ≥18 years resident in Auckland, New Zealand (NZ) who want to quit smoking. Intervention: Stratified blocked randomisation to allocate participants to either Elusion™ e-cigarettes with nicotine cartridges (16 mg) or with placebo cartridges (i.e. no nicotine), or to nicotine patch (21 mg) alone. Participants randomised to the e-cigarette groups will be told to use them ad libitum for one week before and 12 weeks after quit day, while participants randomised to patches will be told to use them daily for the same period. All participants will be offered behavioural support to quit from the NZ Quitline. Primary outcome: Biochemically verified (exhaled carbon monoxide) continuous abstinence at six months after quit day. Sample size: 657 people (292 in both the nicotine e-cigarette and nicotine patch groups and 73 in the placebo e-cigarettes group) will provide 80% power at p = 0.05 to detect an absolute difference of 10% in abstinence between the nicotine e-cigarette and nicotine patch groups, and 15% between the nicotine and placebo e-cigarette groups. Discussion This trial will inform international debate and policy on the regulation and

  14. Clinical trials profile: professionals and sites.

    PubMed

    Paschoale, Helena S; Barbosa, Fernanda R; Nita, Marcelo E; Carrilho, Flair J; Ono-Nita, Suzane Kioko

    2010-09-01

    Clinical trial is considered a breakthrough method in medicine and essential to the development of new drugs. Clinical trials that comply with international and national regulations require an appropriate infrastructure and team qualification. The goal of this study was to evaluate clinical trial groups in Brazil: professional qualification, site structure regulatory knowledge and Good Clinical Practice (GCP) adherence. This is a transversal study with investigators (PI) and sub investigator (SI). PI and SI data were initially identified from Curriculum Lattes from National Advice of Scientific and Technological Development. The study participants were submitted to a questionnaire, which was composed of qualitative and quantitative questions. A hundred PI and SI were interviewed. The most representative Brazilian regions were Southeast (68%) and South (18%). The main institutions involved were HCFMUSP complex and UNIFESP among others institutions. Academic graduation is observed in 86% of them and the higher degree is Doctorate (62%). 91% had GCP knowledge although only 74% had formal training. About the team, all of them are multidisciplinary with majority of nurses and pharmaceuticals. 88% had GCP knowledge although only 77% had formal training. 36%, 60% and 44% of clinical trials were in phase II, III and IV. In conclusion, researchers have appropriate skills and knowledge to perform clinical studies however there is still a need for training. The centers where the researchers work, have trained staff and adequate infrastructure for conducting clinical trials phase II, III and IV.

  15. Enhancing clinical evidence by proactively building quality into clinical trials

    PubMed Central

    Meeker-O’Connell, Ann; Glessner, Coleen; Behm, Mark; Mulinde, Jean; Roach, Nancy; Sweeney, Fergus; Tenaerts, Pamela; Landray, Martin J

    2016-01-01

    Background: Stakeholders across the clinical trial enterprise have expressed concern that the current clinical trial enterprise is unsustainable. The cost and complexity of trials have continued to increase, threatening our ability to generate reliable evidence essential for making appropriate decisions concerning the benefits and harms associated with clinical interventions. Overcoming this inefficiency rests on improving protocol design, trial planning, and quality oversight. Methods: The Clinical Trials Transformation Initiative convened a project to evaluate methods to prospectively build quality into the scientific and operational design of clinical trials (“quality-by-design”), such that trials are feasible to conduct and important errors are prevented rather than remediated. A working group evaluated aspects of trial design and oversight and developed the Clinical Trials Transformation Initiative quality-by-design principles document, outlining a series of factors generally relevant to the reliability of trial conclusions and to patient safety. These principles were then applied and further refined during a series of hands-on workshops to evaluate their utility in facilitating proactive, cross-functional dialogue, and decision-making about trial design and planning. Following these workshops, independent qualitative interviews were conducted with 19 workshop attendees to explore the potential challenges for implementing a quality-by-design approach to clinical trials. The Clinical Trials Transformation Initiative project team subsequently developed recommendations and an online resource guide to support implementation of this approach. Conclusion: The Clinical Trials Transformation Initiative quality-by-design principles provide a framework for assuring that clinical trials adequately safeguard participants and provide reliable information on which to make decisions on the effects of treatments. The quality-by-design workshops highlighted the value of

  16. HPTN 071 (PopART): Rationale and design of a cluster-randomised trial of the population impact of an HIV combination prevention intervention including universal testing and treatment – a study protocol for a cluster randomised trial

    PubMed Central

    2014-01-01

    Background Effective interventions to reduce HIV incidence in sub-Saharan Africa are urgently needed. Mathematical modelling and the HIV Prevention Trials Network (HPTN) 052 trial results suggest that universal HIV testing combined with immediate antiretroviral treatment (ART) should substantially reduce incidence and may eliminate HIV as a public health problem. We describe the rationale and design of a trial to evaluate this hypothesis. Methods/Design A rigorously-designed trial of universal testing and treatment (UTT) interventions is needed because: i) it is unknown whether these interventions can be delivered to scale with adequate uptake; ii) there are many uncertainties in the models such that the population-level impact of these interventions is unknown; and ii) there are potential adverse effects including sexual risk disinhibition, HIV-related stigma, over-burdening of health systems, poor adherence, toxicity, and drug resistance. In the HPTN 071 (PopART) trial, 21 communities in Zambia and South Africa (total population 1.2 m) will be randomly allocated to three arms. Arm A will receive the full PopART combination HIV prevention package including annual home-based HIV testing, promotion of medical male circumcision for HIV-negative men, and offer of immediate ART for those testing HIV-positive; Arm B will receive the full package except that ART initiation will follow current national guidelines; Arm C will receive standard of care. A Population Cohort of 2,500 adults will be randomly selected in each community and followed for 3 years to measure the primary outcome of HIV incidence. Based on model projections, the trial will be well-powered to detect predicted effects on HIV incidence and secondary outcomes. Discussion Trial results, combined with modelling and cost data, will provide short-term and long-term estimates of cost-effectiveness of UTT interventions. Importantly, the three-arm design will enable assessment of how much could be achieved by

  17. Next-generation clinical trials: Novel strategies to address the challenge of tumor molecular heterogeneity

    PubMed Central

    Catenacci, Daniel V.T.

    2014-01-01

    The promise of ‘personalized cancer care’ with therapies toward specific molecular aberrations has potential to improve outcomes. However, there is recognized heterogeneity within any given tumor-type from patient to patient (inter-patient heterogeneity), and within an individual (intra-patient heterogeneity) as demonstrated by molecular evolution through space (primary tumor to metastasis) and time (after therapy). These issues have become hurdles to advancing cancer treatment outcomes with novel molecularly targeted agents. Classic trial design paradigms are challenged by heterogeneity, as they are unable to test targeted therapeutics against low frequency genomic ‘oncogenic driver’ aberrations with adequate power. Usual accrual difficulties to clinical trials are exacerbated by low frequencies of any given molecular driver. To address these challenges, there is need for innovative clinical trial designs and strategies implementing novel diagnostic biomarker technologies to account for inter-patient molecular diversity and scarce tissue for analysis. Importantly, there is also need for pre-defined treatment priority algorithms given numerous aberrations commonly observed within any one individual sample. Access to multiple available therapeutic agents simultaneously is crucial. Finally intra-patient heterogeneity through time may be addressed by serial biomarker assessment at the time of tumor progression. This report discusses various ‘next-generation’ biomarker-driven trial designs and their potentials and limitations to tackle these recognized molecular heterogeneity challenges. Regulatory hurdles, with respect to drug and companion diagnostic development and approval, are considered. Focus is on the ‘Expansion Platform Design Types I and II’, the latter demonstrated with a first example, ‘PANGEA: Personalized Anti-Neoplastics for Gastro-Esophageal Adenocarcinoma’. Applying integral medium-throughput genomic and proteomic assays along with

  18. The Marine Air-Ground Team: Still Not Adequately Training for the Urban Fight/The Marine Air-Ground Team: Still Not Adequately Trained for the Urban Fight

    DTIC Science & Technology

    2006-02-01

    1 The Marine Air-Ground Team: Still Not Adequately Training for the Urban Fight Subject Area Training EWS 2006...The Marine Air-Ground Team: Still Not Adequately Training for the Urban Fight Submitted by Captain RC Rybka to Majors GC Schreffler and RR...estimated to average 1 hour per response , including the time for reviewing instructions, searching existing data sources, gathering and maintaining the

  19. The placental pursuit for an adequate oxidant balance between the mother and the fetus

    PubMed Central

    Herrera, Emilio A.; Krause, Bernardo; Ebensperger, German; Reyes, Roberto V.; Casanello, Paola; Parra-Cordero, Mauro; Llanos, Anibal J.

    2014-01-01

    The placenta is the exchange organ that regulates metabolic processes between the mother and her developing fetus. The adequate function of this organ is clearly vital for a physiologic gestational process and a healthy baby as final outcome. The umbilico-placental vasculature has the capacity to respond to variations in the materno-fetal milieu. Depending on the intensity and the extensity of the insult, these responses may be immediate-, mediate-, and long-lasting, deriving in potential morphostructural and functional changes later in life. These adjustments usually compensate the initial insults, but occasionally may switch to long-lasting remodeling and dysfunctional processes, arising maladaptation. One of the most challenging conditions in modern perinatology is hypoxia and oxidative stress during development, both disorders occurring in high-altitude and in low-altitude placental insufficiency. Hypoxia and oxidative stress may induce endothelial dysfunction and thus, reduction in the perfusion of the placenta and restriction in the fetal growth and development. This Review will focus on placental responses to hypoxic conditions, usually related with high-altitude and placental insufficiency, deriving in oxidative stress and vascular disorders, altering fetal and maternal health. Although day-to-day clinical practice, basic and clinical research are clearly providing evidence of the severe impact of oxygen deficiency and oxidative stress establishment during pregnancy, further research on umbilical and placental vascular function under these conditions is badly needed to clarify the myriad of questions still unsettled. PMID:25009498

  20. Prevention of mother to child transmission lay counsellors: Are they adequately trained?

    PubMed

    Thurling, Catherine H; Harris, Candice

    2012-06-05

    South Africa's high prevalence of human immunodeficiency virus (HIV) infected women requires a comprehensive health care approach to pregnancy because of the added risk of their HIV status. As a result of the shortage of health care workers in South Africa, lay counsellors play important roles in the prevention of mother to child transmission of HIV (PMTCT). There is no standardization of training of lay counsellors in South Africa, and training varies in length depending on the training organisation. The study aimed to investigate the training of lay counsellors by analysing their training curricula and interviewing lay counsellors about their perceptions of their training. A two phase research method was applied. Phase one documented an analysis of the training curricula. Phase two was semi-structured interviews with the participants. Purposive sampling was undertaken for this study. The total sample size was 13 people, with a final sample of 9 participants, determined at the point of data saturation. The research was qualitative, descriptive and contextual in design. The curricula analysed had different styles of delivery, and the approaches to learning and courses varied, resulting in inconsistent training outcomes. A need for supervision and mentorship in the working environment was also noted. The training of lay counsellors needs to be adapted to meet the extended roles that they are playing in PMTCT. The standardization of training programmes, and the incorporation of a system of mentorship in the work environment, would ensure that the lay counsellors are adequately prepared for their role in PMTCT.

  1. Improved ASTM G72 Test Method for Ensuring Adequate Fuel-to-Oxidizer Ratios

    NASA Technical Reports Server (NTRS)

    Juarez, Alfredo; Harper, Susana Tapia

    2016-01-01

    The ASTM G72/G72M-15 Standard Test Method for Autogenous Ignition Temperature of Liquids and Solids in a High-Pressure Oxygen-Enriched Environment is currently used to evaluate materials for the ignition susceptibility driven by exposure to external heat in an enriched oxygen environment. Testing performed on highly volatile liquids such as cleaning solvents has proven problematic due to inconsistent test results (non-ignitions). Non-ignition results can be misinterpreted as favorable oxygen compatibility, although they are more likely associated with inadequate fuel-to-oxidizer ratios. Forced evaporation during purging and inadequate sample size were identified as two potential causes for inadequate available sample material during testing. In an effort to maintain adequate fuel-to-oxidizer ratios within the reaction vessel during test, several parameters were considered, including sample size, pretest sample chilling, pretest purging, and test pressure. Tests on a variety of solvents exhibiting a range of volatilities are presented in this paper. A proposed improvement to the standard test protocol as a result of this evaluation is also presented. Execution of the final proposed improved test protocol outlines an incremental step method of determining optimal conditions using increased sample sizes while considering test system safety limits. The proposed improved test method increases confidence in results obtained by utilizing the ASTM G72 autogenous ignition temperature test method and can aid in the oxygen compatibility assessment of highly volatile liquids and other conditions that may lead to false non-ignition results.

  2. Cardiac catecholamines in rats fed copper deficient or copper adequate diets containing fructose or starch

    SciTech Connect

    Scholfield, D.J.; Fields, M.; Beal, T.; Lewis, C.G.; Behall, K.M. )

    1989-02-09

    The symptoms of copper (Cu) deficiency are known to be more severe when rats are fed a diet with fructose (F) as the principal carbohydrate. Mortality, in males, due to cardiac abnormalities usually occurs after five weeks of a 62% F, 0.6 ppm Cu deficient diet. These effects are not observed if cornstarch (CS) is the carbohydrate (CHO) source. Studies with F containing diets have shown increased catecholamine (C) turnover rates while diets deficient in Cu result in decreased norepinephrine (N) levels in tissues. Dopamine B-hydroxylase (EC 1.14.17.1) is a Cu dependent enzyme which catalyzes the conversion of dopamine (D) to N. An experiment was designed to investigate the effects of CHO and dietary Cu on levels of three C in cardiac tissue. Thirty-two male and female Sprague-Dawley rats were fed Cu deficient or adequate diets with 60% of calories from F or CS for 6 weeks. N, epinephrine (E) and D were measured by HPLC. Statistical analysis indicates that Cu deficiency tends to decrease N levels, while having the reverse effect on E. D did not appear to change. These findings indicate that Cu deficiency but not dietary CHO can affect the concentration of N and E in rat cardiac tissue.

  3. Radiation dose reduction in invasive cardiology by restriction to adequate instead of optimized picture quality.

    PubMed

    Kuon, Eberhard; Dorn, Christian; Schmitt, Moritz; Dahm, Johannes B

    2003-05-01

    In this study, the cinegraphic image intensifier entrance dose level for coronary angiography was changed in four steps from dose level A (0.041 microGy frame(-1)), allowing high contrast, but coarse mottled background, to level D (0.164 microGy frame(-1)), affording high transparency and sharpness. Using this new approach throughout the course of 404 consecutive cardiac catheterizations, we reduced patient radiation exposures down to 11 to 16% of currently typical values: i.e., mean dose area products of 5.97 Gy cm2 (n = 91), 6.73 (n = 113), 8.11 (n = 91), and 8.90 (n = 109); cinegraphic dose area products of 2.34, 3.64, 4.56, and 5.49; and cinegraphic dose area products frame(-1) of 13.3, 19.8, 27.0, and 30.2 mGy cm2, for levels A, B, C, and D, respectively. The number of cinegraphic frames ranged within 168 to 182 per case. Our results show that during catheterization interventionalists should vary image intensifier entrance dose levels in accordance with documented structure, angulation, and body mass index. With the exception of cases with special requirements, lower dose levels typically guarantee an adequate image quality.

  4. Are neurodegenerative disorder and psychotic manifestations avoidable brain dysfunctions with adequate dietary omega-3?

    PubMed

    Saugstad, Letten F

    2006-01-01

    The present mismatch between what our brain needs, and the modern diet neglects our marine heritage. Last century, the priority in nutrition and food production was to achieve a high protein diet and somatic growth and function. The dietary content of omega-3 (N-3) required by the brain was neglected although evidence for the essentiality of certain fatty acids was published in 1929 and specifically re-affirmed for omega 3 in the brain in the 1970s. Cognitive decline with age and neurodegenerative disorder with dementia are now rising. This review describes signs of N-3 deficit in Alzheimer and Parkinson Disease, where maximum change involves the primary sites: olfactory cortex and the hippocampus. The olfactory agnosia observed in schizophrenia supports an N-3 deficit as does a reduction of key ologodendrocyte- and myelin-related genes in this disorder and affective disorder, where a rise in dementia accords with a deficit of N-3 also in this disorder. N-3 normalizes cerebral excitability at all levels. That the two disorders are localized at the extremes of excitability, is supported by their opposing treatments: convulsant neuroleptics and anti-epileptic antidepressants. An adequate N-3 diet will probably prevent most psychotic episodes and prove that neurodegenerative disorder with dementia is also to a large extent not only preventable but avoidable.

  5. Are neurodegenerative disorder and psychotic manifestations avoidable brain dysfunctions with adequate dietary omega-3?

    PubMed

    Saugstad, Letten F

    2006-01-01

    The present mismatch between what our brain needs, and the modern diet neglects our marine heritage. Last century, the priority in nutrition and food production was to achieve a high protein diet and somatic growth and function. The dietary content of omega-3 (N-3) required by the brain was neglected although evidence for the essentiality of certain fatty acids was published in 1929 and specifically re-affirmed for omega 3 in the brain in the 1970s. Cognitive decline with age and neurodegenerative disorder with dementia are now rising. This review describes signs of N-3 deficit in Alzheimer and Parkinson Disease, where maximum change involves the primary sites: olfactory cortex and the hippocampus. The olfactory agnosia observed in schizophrenia supports an N-3 deficit as does a reduction of key ologodendrocyte- and myelin-related genes in this disorder and affective disorder, where a rise in dementia accords with a deficit of N-3 also in this disorder. N-3 normalizes cerebral excitability at all levels. That the two disorders are localized at the extremes of excitability, is supported by their opposing treatments: convulsant neuroleptics and anti-epileptic anti-depressants. An adequate N-3 diet will probably prevent most psychotic episodes and prove that neurodegenerative disorder with dementia is also to a large extent not only preventable but avoidable.

  6. Are image quality metrics adequate to evaluate the quality of geometric objects?

    NASA Astrophysics Data System (ADS)

    Rogowitz, Bernice E.; Rushmeier, Holly E.

    2001-06-01

    Geometric objects are often represented by many millions of triangles or polygons, which limits the ease with which they can be transmitted and displayed electronically. This has lead to the development of many algorithms for simplifying geometric models, and to the recognition that metrics are required to evaluate their success. The goal is to create computer graphic renderings of the object that do not appear to be degraded to a human observer. The perceptual evaluation of simplified objects is a new topic. One approach has been to sue image-based metrics to predict the perceived degradation of simplified 3D models. Since that 2D images of 3D objects can have significantly different perceived quality, depending on the direction of the illumination, 2D measures of image quality may not adequately capture the perceived quality of 3D objects. To address this question, we conducted experiments in which we explicitly compared the perceived quality of animated 3D objects and their corresponding 2D still image projections. Our results suggest that 2D judgements do not provide a good predictor of 3D image quality, and identify a need to develop 'object quality metrics.'

  7. A high UV environment does not ensure adequate Vitamin D status

    NASA Astrophysics Data System (ADS)

    Kimlin, M. G.; Lang, C. A.; Brodie, A.; Harrison, S.; Nowak, M.; Moore, M. R.

    2006-12-01

    Queensland has the highest rates of skin cancer in the world and due to the high levels of solar UV in this region it is assumed that incidental UV exposure should provide adequate vitamin D status for the population. This research was undertaken to test this assumption among healthy free-living adults in south-east Queensland, Australia (27°S), at the end of winter. This research was approved by Queensland University of Technology Human Research Ethics Committee and conducted under the guidelines of the Declaration of Helsinki. 10.2% of the sample had serum vitamin D levels below 25nm/L (deficiency) and a further 32.3% had levels between 25nm/L and 50nm/L (insufficiency). Vitamin D deficiency and insufficiency can occur at the end of winter, even in sunny climates. The wintertime UV levels in south-east Queensland (UV index 4-6) are equivalent to summertime UV levels in northern regions of Europe and the USA. These ambient UV levels are sufficient to ensure synthesis of vitamin D requirements. We investigated individual UV exposure (through a self reported sun exposure questionnaire) and found correlations between exposure and Vitamin D status. Further research is needed to explore the interactions between the solar UV environment and vitamin D status, particularly in high UV environments, such as Queensland.

  8. Determination of the need for selenium by chicks fed practical diets adequate in vitamin E

    SciTech Connect

    Combs, G.F. Jr.; Su, Q.; Liu, C.H.; Sinisalo, M.; Combs, S.B.

    1986-03-01

    Experiments were conducted to compare the dietary needs for selenium (Se) by chicks fed either purified (amino acid-based) or practical (corn- and soy-based) diets that were adequate with respect to vitamin E (i.e., contained 100 IU/kg) and all other known nutrients with the single exception of Se (i.e., contained only 0.10 ppm Se). Studies were conducted in Ithaca using Single Comb White Leghorn chicks fed the purified basal diet and in Beijing using chicks of the same breed fed either the same purified basal diet or the practical diet formulated to be similar to that used in poultry production in some parts of China and the US. Results showed that each basal diet produced severe depletion of Se-dependent glutathione peroxidase (SeGSHpx) in plasma, liver and pancreas according to the same time-course, but that other consequences of severe uncomplicated Se deficiency were much more severe among chicks fed the purified diet (e.g., growth depression, pancreatic dysfunction as indicated by elevated plasma amylase and abnormal pancreatic histology). Chicks fed the practical Se-deficient diet showed reduced pancreas levels of copper, zinc and molybdenum and elevated plasma levels of iron; they required ca. 0.10 ppm dietary Se to sustain normal SeGSHpx in several tissues and to prevent elevated amylase in plasma. The dietary Se requirement of the chick is, therefore, estimated to be 0.10 ppm.

  9. Salt, blood pressure and cardiovascular risk: what is the most adequate preventive strategy? A Swiss perspective

    PubMed Central

    Burnier, Michel; Wuerzner, Gregoire; Bochud, Murielle

    2015-01-01

    Among the various strategies to reduce the incidence of non-communicable diseases reduction of sodium intake in the general population has been recognized as one of the most cost-effective means because of its potential impact on the development of hypertension and cardiovascular diseases. Yet, this strategic health recommendation of the WHO and many other international organizations is far from being universally accepted. Indeed, there are still several unresolved scientific and epidemiological questions that maintain an ongoing debate. Thus what is the adequate low level of sodium intake to recommend to the general population and whether national strategies should be oriented to the overall population or only to higher risk fractions of the population such as salt-sensitive patients are still discussed. In this paper, we shall review the recent results of the literature regarding salt, blood pressure and cardiovascular risk and we present the recommendations recently proposed by a group of experts of Switzerland. The propositions of the participating medical societies are to encourage national health authorities to continue their discussion with the food industry in order to reduce the sodium intake of food products with a target of mean salt intake of 5–6 grams per day in the population. Moreover, all initiatives to increase the information on the effect of salt on health and on the salt content of food are supported. PMID:26321959

  10. PG medical training and accreditation: responsibility of the government for the adequate health service delivery.

    PubMed

    Bhattarai, M D

    2012-09-01

    On one hand there is obvious inadequate health coverage to the rural population and on the other hand the densely populated urban area is facing the triple burden of increasing non-communicable and communicable health problems and the rising health cost. The postgraduate medical training is closely interrelated with the adequate health service delivery and health economics. In relation to the prevailing situation, the modern medical education trend indicates the five vital issues. These are i). Opportunity needs to be given to all MBBS graduates for General Specialist and Sub-Specialist Training inside the country to complete their medical education, ii). Urgent need for review of PG residential training criteria including appropriate bed and teacher criteria as well as entry criteria and eligibility criteria, iii). Involvement of all available units of hospitals fulfilling the requirements of the residential PG training criteria, iv). PG residential trainings involve doing the required work in the hospitals entitling them full pay and continuation of the service without any training fee or tuition fee, and v). Planning of the proportions of General Specialty and Sub-Specialty Training fields, particularly General Practice (GP) including its career and female participation. With increased number of medical graduates, now it seems possible to plan for optimal health coverage to the populations with appropriate postgraduate medical training. The medical professionals and public health workers must make the Government aware of the vital responsibility and the holistic approach required.

  11. A test of the cerebellar hypothesis of dyslexia in adequate and inadequate responders to reading intervention.

    PubMed

    Barth, Amy E; Denton, Carolyn A; Stuebing, Karla K; Fletcher, Jack M; Cirino, Paul T; Francis, David J; Vaughn, Sharon

    2010-05-01

    The cerebellar hypothesis of dyslexia posits that cerebellar deficits are associated with reading disabilities and may explain why some individuals with reading disabilities fail to respond to reading interventions. We tested these hypotheses in a sample of children who participated in a grade 1 reading intervention study (n = 174) and a group of typically achieving children (n = 62). At posttest, children were classified as adequately responding to the intervention (n = 82), inadequately responding with decoding and fluency deficits (n = 36), or inadequately responding with only fluency deficits (n = 56). Based on the Bead Threading and Postural Stability subtests from the Dyslexia Screening Test-Junior, we found little evidence that assessments of cerebellar functions were associated with academic performance or responder status. In addition, we did not find evidence supporting the hypothesis that cerebellar deficits are more prominent for poor readers with "specific" reading disabilities (i.e., with discrepancies relative to IQ) than for poor readers with reading scores consistent with IQ. In contrast, measures of phonological awareness, rapid naming, and vocabulary were strongly associated with responder status and academic outcomes. These results add to accumulating evidence that fails to associate cerebellar functions with reading difficulties.

  12. Ipragliflozin effectively reduced visceral fat in Japanese patients with type 2 diabetes under adequate diet therapy.

    PubMed

    Yamamoto, Chiho; Miyoshi, Hideaki; Ono, Kota; Sugawara, Hajime; Kameda, Reina; Ichiyama, Mei; Yamamoto, Kohei; Nomoto, Hiroshi; Nakamura, Akinobu; Atsumi, Tatsuya

    2016-06-30

    To investigate if ipragliflozin, a novel sodium-glucose co-transporter 2 inhibitor, alters body composition and to identify variables associated with reductions in visceral adipose tissue in Japanese patients with type 2 diabetes mellitus. This prospective observational study enrolled Japanese participants with type 2 diabetes mellitus. Subjects were administered ipragliflozin (50 mg/day) once daily for 16 weeks. Body composition, visceral adipose tissue volume and plasma variables were measured at 0, 8, and 16-weeks. The subjects' lifestyle habits including diet and exercise were evaluated at baseline and 16 weeks. The primary endpoint was defined as the decrease of visceral adipose tissue mass. Twenty-four of 26 enrolled participants completed the study. The visceral adipose tissue decreased significantly (110 ± 33 to 101 ± 36 cm(2), p = 0.005) as well as other parameters for metabolic insufficiency including hemoglobin A1c. Seventy-one % of the total body weight reduction (-2.49 kg) was estimated by a decrease in fat mass (-1.77 kg), and the remaining reduction (22%) by water volume (-0.55 kg). A minor but significant reduction in the skeletal muscle index was also observed. Correlation analyses were performed to identify variables associated with changes in visceral adipose tissue and the only significant variable identified was diet therapy (Spearman's r = -0.416, p = 0.043). Ipragliflozin significantly decreased visceral adipose tissue, and improved parametres for metabolic dysfunction. Adequate diet therapy would be necessary to induce and enhance the therapeutic merit.

  13. Gaussian membership functions are most adequate in representing uncertainty in measurements

    NASA Technical Reports Server (NTRS)

    Kreinovich, V.; Quintana, C.; Reznik, L.

    1992-01-01

    In rare situations, like fundamental physics, we perform experiments without knowing what their results will be. In the majority of real-life measurement situations, we more or less know beforehand what kind of results we will get. Of course, this is not the precise knowledge of the type 'the result will be between alpha - beta and alpha + beta,' because in this case, we would not need any measurements at all. This is usually a knowledge that is best represented in uncertain terms, like 'perhaps (or 'most likely', etc.) the measured value x is between alpha - beta and alpha + beta.' Traditional statistical methods neglect this additional knowledge and process only the measurement results. So it is desirable to be able to process this uncertain knowledge as well. A natural way to process it is by using fuzzy logic. But, there is a problem; we can use different membership functions to represent the same uncertain statements, and different functions lead to different results. What membership function do we choose? In the present paper, we show that under some reasonable assumptions, Gaussian functions mu(x) = exp(-beta(x(exp 2))) are the most adequate choice of the membership functions for representing uncertainty in measurements. This representation was efficiently used in testing jet engines to airplanes and spaceships.

  14. Aurally-adequate time-frequency analysis for scattered sound in auditoria

    NASA Astrophysics Data System (ADS)

    Norris, Molly K.; Xiang, Ning; Kleiner, Mendel

    2005-04-01

    The goal of this work was to apply an aurally-adequate time-frequency analysis technique to the analysis of sound scattering effects in auditoria. Time-frequency representations were developed as a motivated effort that takes into account binaural hearing, with a specific implementation of interaural cross-correlation process. A model of the human auditory system was implemented in the MATLAB platform based on two previous models [A. Härmä and K. Palomäki, HUTear, Espoo, Finland; and M. A. Akeroyd, A. Binaural Cross-correlogram Toolbox for MATLAB (2001), University of Sussex, Brighton]. These stages include proper frequency selectivity, the conversion of the mechanical motion of the basilar membrane to neural impulses, and binaural hearing effects. The model was then used in the analysis of room impulse responses with varying scattering characteristics. This paper discusses the analysis results using simulated and measured room impulse responses. [Work supported by the Frank H. and Eva B. Buck Foundation.

  15. Research Areas - Clinical Trials

    Cancer.gov

    Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

  16. Teaching Drama Via Trials.

    ERIC Educational Resources Information Center

    Mansour, Wisam

    1998-01-01

    Suggests using a court trial as an activity for teaching drama to English-as-a-foreign-language (EFL) students. Describes use of a court trial for teaching Macbeth to EFL students in Jordan. (Author/VWL)

  17. Hepatitis C: Clinical Trials

    MedlinePlus

    ... and Public Home » Hepatitis C » Treatment Decisions Viral Hepatitis Menu Menu Viral Hepatitis Viral Hepatitis Home For ... can I find out about participating in a hepatitis C clinical trial? Many trials are being conducted ...

  18. Salem Witch Trials.

    ERIC Educational Resources Information Center

    Ray, Benjamin

    2003-01-01

    Presents a lesson plan that focuses on the Salem (Massachusetts) witchcraft trials. Explains that the first section of the lesson has students learn about the trials as described in the court records. The second section asks students to interpret various images of the trials. (CMK)

  19. 45 CFR 2508.10 - Who has the responsibility for maintaining adequate technical, physical, and security safeguards...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... adequate technical, physical, and security safeguards to prevent unauthorized disclosure or destruction of... security safeguards to prevent unauthorized disclosure or destruction of manual and automatic record..., and security safeguards to prevent unauthorized disclosure or destruction of manual and...

  20. 45 CFR 2508.10 - Who has the responsibility for maintaining adequate technical, physical, and security safeguards...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... adequate technical, physical, and security safeguards to prevent unauthorized disclosure or destruction of... security safeguards to prevent unauthorized disclosure or destruction of manual and automatic record..., and security safeguards to prevent unauthorized disclosure or destruction of manual and...

  1. 45 CFR 2508.10 - Who has the responsibility for maintaining adequate technical, physical, and security safeguards...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... adequate technical, physical, and security safeguards to prevent unauthorized disclosure or destruction of... security safeguards to prevent unauthorized disclosure or destruction of manual and automatic record..., and security safeguards to prevent unauthorized disclosure or destruction of manual and...

  2. Homodecoupled 1,1- and 1,n-ADEQUATE: Pivotal NMR Experiments for the Structure Revision of Cryptospirolepine.

    PubMed

    Saurí, Josep; Bermel, Wolfgang; Buevich, Alexei V; Sherer, Edward C; Joyce, Leo A; Sharaf, Maged H M; Schiff, Paul L; Parella, Teodor; Williamson, R Thomas; Martin, Gary E

    2015-08-24

    Cryptospirolepine is the most structurally complex alkaloid discovered and characterized thus far from any Cryptolepis specie. Characterization of several degradants of the original, sealed NMR sample a decade after the initial report called the validity of the originally proposed structure in question. We now report the development of improved, homodecoupled variants of the 1,1- and 1,n-ADEQUATE (HD-ADEQUATE) NMR experiments; utilization of these techniques was critical to successfully resolving long-standing structural questions associated with crytospirolepine.

  3. Is the Current US Navy Pacific Basing Structure Adequate for the Twenty-First Century?

    DTIC Science & Technology

    2006-12-15

    fiscal constraints, and without an Asian continental power clearly capable of mounting a credible military and naval threat to America, a reassessment...the devastating effects of Mount Pinatubo’s eruption on Clark Air force Base resulted in the closure of the US Naval base in Subic Bay, Philippines...Seventh Fleet ships converged on the Philippines to evacuate US military and families after the eruption of Mount Pinatubo. During Operation Restore Hope

  4. On sample size estimation and re-estimation adjusting for variability in confirmatory trials.

    PubMed

    Wu, Pei-Shien; Lin, Min; Chow, Shein-Chung

    2016-01-01

    Sample size estimation (SSE) is an important issue in the planning of clinical studies. While larger studies are likely to have sufficient power, it may be unethical to expose more patients than necessary to answer a scientific question. Budget considerations may also cause one to limit the study to an adequate size to answer the question at hand. Typically at the planning stage, a statistically based justification for sample size is provided. An effective sample size is usually planned under a pre-specified type I error rate, a desired power under a particular alternative and variability associated with the observations recorded. The nuisance parameter such as the variance is unknown in practice. Thus, information from a preliminary pilot study is often used to estimate the variance. However, calculating the sample size based on the estimated nuisance parameter may not be stable. Sample size re-estimation (SSR) at the interim analysis may provide an opportunity to re-evaluate the uncertainties using accrued data and continue the trial with an updated sample size. This article evaluates a proposed SSR method based on controlling the variability of nuisance parameter. A numerical study is used to assess the performance of proposed method with respect to the control of type I error. The proposed method and concepts could be extended to SSR approaches with respect to other criteria, such as maintaining effect size, achieving conditional power, and reaching a desired reproducibility probability.

  5. Maintaining Adequate Carbon Dioxide Washout for an Advanced Extravehicular Mobility Unit

    NASA Technical Reports Server (NTRS)

    Chullen, Cinda; Navarro, Moses; Conger, Bruce; Korona, Adam; McMillin, Summer; Norcross, Jason; Swickrath, Mike

    2013-01-01

    Over the past several years, NASA has realized tremendous progress in technology development that is aimed at the production of an Advanced Extravehicular Mobility Unit (AEMU). Of the many functions provided by the spacesuit and portable life support subsystem within the AEMU, delivering breathing gas to the astronaut along with removing the carbon dioxide (CO2) remains one of the most important environmental functions that the AEMU can control. Carbon dioxide washout is the capability of the ventilation flow in the spacesuit helmet to provide low concentrations of CO2 to the crew member to meet breathing requirements. CO2 washout performance is a critical parameter needed to ensure proper and sufficient designs in a spacesuit and in vehicle applications such as sleep stations and hygiene compartments. Human testing to fully evaluate and validate CO2 washout performance is necessary but also expensive due to the levied safety requirements. Moreover, correlation of math models becomes challenging because of human variability and movement. To supplement human CO2 washout testing, a breathing capability will be integrated into a suited manikin test apparatus to provide a safe, lower cost, stable, easily modeled alternative to human testing. Additionally, this configuration provides NASA Johnson Space Center (JSC) the capability to evaluate CO2 washout under off-nominal conditions that would otherwise be unsafe for human testing or difficult due to fatigue of a test subject. Testing has been under way in-house at JSC and analysis has been initiated to evaluate whether the technology provides sufficient performance in ensuring that the CO2 is removed sufficiently and the ventilation flow is adequate for maintaining CO2 washout in the AEMU spacesuit helmet of the crew member during an extravehicular activity. This paper will review recent CO2 washout testing and analysis activities, testing planned in-house with a spacesuit simulator, and the associated analytical work

  6. Ensuring Adequate Health and Safety Information for Decision Makers during Large-Scale Chemical Releases

    NASA Astrophysics Data System (ADS)

    Petropoulos, Z.; Clavin, C.; Zuckerman, B.

    2015-12-01

    The 2014 4-Methylcyclohexanemethanol (MCHM) spill in the Elk River of West Virginia highlighted existing gaps in emergency planning for, and response to, large-scale chemical releases in the United States. The Emergency Planning and Community Right-to-Know Act requires that facilities with hazardous substances provide Material Safety Data Sheets (MSDSs), which contain health and safety information on the hazardous substances. The MSDS produced by Eastman Chemical Company, the manufacturer of MCHM, listed "no data available" for various human toxicity subcategories, such as reproductive toxicity and carcinogenicity. As a result of incomplete toxicity data, the public and media received conflicting messages on the safety of the contaminated water from government officials, industry, and the public health community. Two days after the governor lifted the ban on water use, the health department partially retracted the ban by warning pregnant women to continue avoiding the contaminated water, which the Centers for Disease Control and Prevention deemed safe three weeks later. The response in West Virginia represents a failure in risk communication and calls to question if government officials have sufficient information to support evidence-based decisions during future incidents. Research capabilities, like the National Science Foundation RAPID funding, can provide a solution to some of the data gaps, such as information on environmental fate in the case of the MCHM spill. In order to inform policy discussions on this issue, a methodology for assessing the outcomes of RAPID and similar National Institutes of Health grants in the context of emergency response is employed to examine the efficacy of research-based capabilities in enhancing public health decision making capacity. The results of this assessment highlight potential roles rapid scientific research can fill in ensuring adequate health and safety data is readily available for decision makers during large

  7. Determining median urinary iodine concentration that indicates adequate iodine intake at population level.

    PubMed Central

    Delange, François; de Benoist, Bruno; Burgi, Hans

    2002-01-01

    OBJECTIVE: Urinary iodine concentration is the prime indicator of nutritional iodine status and is used to evaluate population-based iodine supplementation. In 1994, WHO, UNICEF and ICCIDD recommended median urinary iodine concentrations for populations of 100- 200 micro g/l, assuming the 100 micro g/l threshold would limit concentrations <50 micro g/l to 100 micro g/l. The total population was 55 892, including 35 661 (64%) schoolchildren. Median urinary iodine concentrations were 111-540 (median 201) micro g/l for all populations, 100-199 micro g/l in 23 (48%) populations and >/=200 micro g/l in 25 (52%). The frequencies of values <50 micro g/l were 0-20.8 (mean 4.8%) overall and 7.2% and 2.5% in populations with medians of 100-199 micro g/l and >200 micro g/l, respectively. The frequency reached 20% only in two places where iodine had been supplemented for <2 years. CONCLUSION: The frequency of urinary iodine concentrations <50 micro g/l in populations with median urinary iodine concentrations >/=100 micro g/l has been overestimated. The threshold of 100 micro g/l does not need to be increased. In populations, median urinary iodine concentrations of 100-200 micro g/l indicate adequate iodine intake and optimal iodine nutrition. PMID:12219154

  8. Defining an adequate sample of earlywood vessels for retrospective injury detection in diffuse-porous species.

    PubMed

    Arbellay, Estelle; Corona, Christophe; Stoffel, Markus; Fonti, Patrick; Decaulne, Armelle

    2012-01-01

    Vessels of broad-leaved trees have been analyzed to study how trees deal with various environmental factors. Cambial injury, in particular, has been reported to induce the formation of narrower conduits. Yet, little or no effort has been devoted to the elaboration of vessel sampling strategies for retrospective injury detection based on vessel lumen size reduction. To fill this methodological gap, four wounded individuals each of grey alder (Alnus incana (L.) Moench) and downy birch (Betula pubescens Ehrh.) were harvested in an avalanche path. Earlywood vessel lumina were measured and compared for each tree between the injury ring built during the growing season following wounding and the control ring laid down the previous year. Measurements were performed along a 10 mm wide radial strip, located directly next to the injury. Specifically, this study aimed at (i) investigating the intra-annual duration and local extension of vessel narrowing close to the wound margin and (ii) identifying an adequate sample of earlywood vessels (number and intra-ring location of cells) attesting to cambial injury. Based on the results of this study, we recommend analyzing at least 30 vessels in each ring. Within the 10 mm wide segment of the injury ring, wound-induced reduction in vessel lumen size did not fade with increasing radial and tangential distances, but we nevertheless advise favoring early earlywood vessels located closest to the injury. These findings, derived from two species widespread across subarctic, mountainous, and temperate regions, will assist retrospective injury detection in Alnus, Betula, and other diffuse-porous species as well as future related research on hydraulic implications after wounding.

  9. Defining an Adequate Sample of Earlywood Vessels for Retrospective Injury Detection in Diffuse-Porous Species

    PubMed Central

    Arbellay, Estelle; Corona, Christophe; Stoffel, Markus; Fonti, Patrick; Decaulne, Armelle

    2012-01-01

    Vessels of broad-leaved trees have been analyzed to study how trees deal with various environmental factors. Cambial injury, in particular, has been reported to induce the formation of narrower conduits. Yet, little or no effort has been devoted to the elaboration of vessel sampling strategies for retrospective injury detection based on vessel lumen size reduction. To fill this methodological gap, four wounded individuals each of grey alder (Alnus incana (L.) Moench) and downy birch (Betula pubescens Ehrh.) were harvested in an avalanche path. Earlywood vessel lumina were measured and compared for each tree between the injury ring built during the growing season following wounding and the control ring laid down the previous year. Measurements were performed along a 10 mm wide radial strip, located directly next to the injury. Specifically, this study aimed at (i) investigating the intra-annual duration and local extension of vessel narrowing close to the wound margin and (ii) identifying an adequate sample of earlywood vessels (number and intra-ring location of cells) attesting to cambial injury. Based on the results of this study, we recommend analyzing at least 30 vessels in each ring. Within the 10 mm wide segment of the injury ring, wound-induced reduction in vessel lumen size did not fade with increasing radial and tangential distances, but we nevertheless advise favoring early earlywood vessels located closest to the injury. These findings, derived from two species widespread across subarctic, mountainous, and temperate regions, will assist retrospective injury detection in Alnus, Betula, and other diffuse-porous species as well as future related research on hydraulic implications after wounding. PMID:22761707

  10. Adequate antigen availability: a key issue for novel approaches to tumor vaccination and tumor immunotherapy.

    PubMed

    Accolla, Roberto S; Tosi, Giovanna

    2013-03-01

    A crucial parameter for activation of the anti-tumor immune response is an adequate antigen availability (AAA) defined here as the optimal tumor antigen dose and related antigen processing and MHC-II-restricted presentation necessary to efficiently trigger tumor-specific TH cells. We will discuss two distinct experimental systems: a) a preventive anti-tumor vaccination system; b) a therapy-induced anti-tumor vaccination approach. In the first case tumor cells are rendered constitutively MHC-II+ by transfecting them with the MHC-II transcriptional activator CIITA. Here AAA is generated by the function of tumor's newly expressed MHC-II molecules to present tumor-associated antigens to tumor-specific TH cells. In the second case, AAA is generated by treating established tumors with neovasculature-targeted TNFα. In conjuction with Melphalan, targeted TNFα delivery produces extensive areas of tumor necrosis that generate AAA capable of optimally activate tumor-specific TH cells which in turn activate CTL immune effectors. In both experimental systems tumor rejection and persistent and long-lived TH cell anti-tumor memory, responsible of defending the animals from subsequent challenges with tumor cells, are achieved. Based on these and other investigators' results we propose that AAA is a key element for triggering adaptive immune functions resulting in subversion from a pro-tumor to an anti-tumor microenvironment, tumor rejection and acquisition of anti-tumor immune memory. Hypotheses of neuro-immune networks involved in these approaches are discussed. These considerations are important also for the comprehension of how chemotherapy and/or radiation therapies may help to block and/or to eradicate the tumor and for the construction of suitable anti-tumor vaccine strategies.

  11. The Goal of Adequate Nutrition: Can It Be Made Affordable, Sustainable, and Universal?

    PubMed

    McFarlane, Ian

    2016-11-30

    Until about 1900, large proportions of the world population endured hunger and poverty. The 20th century saw world population increase from 1.6 to 6.1 billion, accompanied and to some extent made possible by rapid improvements in health standards and food supply, with associated advances in agricultural and nutrition sciences. In this paper, I use the application of linear programming (LP) in preparation of rations for farm animals to illustrate a method of calculating the lowest cost of a human diet selected from locally available food items, constrained to provide recommended levels of food energy and nutrients; then, to find a realistic minimum cost, I apply the further constraint that the main sources of food energy in the costed diet are weighted in proportion to the actual reported consumption of food items in that area. Worldwide variations in dietary preferences raise the issue as to the sustainability of popular dietary regimes, and the paper reviews the factors associated with satisfying requirements for adequate nutrition within those regimes. The ultimate physical constraints on food supply are described, together with the ways in which climate change may affect those constraints. During the 20th century, food supply increased sufficiently in most areas to keep pace with the rapid increase in world population. Many challenges will need to be overcome if food supply is to continue to meet demand, and those challenges are made more severe by rising expectations of quality of life in the developing world, as well as by the impacts of climate change on agriculture and aquaculture.

  12. The Goal of Adequate Nutrition: Can It Be Made Affordable, Sustainable, and Universal?

    PubMed Central

    McFarlane, Ian

    2016-01-01

    Until about 1900, large proportions of the world population endured hunger and poverty. The 20th century saw world population increase from 1.6 to 6.1 billion, accompanied and to some extent made possible by rapid improvements in health standards and food supply, with associated advances in agricultural and nutrition sciences. In this paper, I use the application of linear programming (LP) in preparation of rations for farm animals to illustrate a method of calculating the lowest cost of a human diet selected from locally available food items, constrained to provide recommended levels of food energy and nutrients; then, to find a realistic minimum cost, I apply the further constraint that the main sources of food energy in the costed diet are weighted in proportion to the actual reported consumption of food items in that area. Worldwide variations in dietary preferences raise the issue as to the sustainability of popular dietary regimes, and the paper reviews the factors associated with satisfying requirements for adequate nutrition within those regimes. The ultimate physical constraints on food supply are described, together with the ways in which climate change may affect those constraints. During the 20th century, food supply increased sufficiently in most areas to keep pace with the rapid increase in world population. Many challenges will need to be overcome if food supply is to continue to meet demand, and those challenges are made more severe by rising expectations of quality of life in the developing world, as well as by the impacts of climate change on agriculture and aquaculture. PMID:28231177

  13. The adequate stimulus for avian short latency vestibular responses to linear translation

    NASA Technical Reports Server (NTRS)

    Jones, T. A.; Jones, S. M.; Colbert, S.

    1998-01-01

    Transient linear acceleration stimuli have been shown to elicit eighth nerve vestibular compound action potentials in birds and mammals. The present study was undertaken to better define the nature of the adequate stimulus for neurons generating the response in the chicken (Gallus domesticus). In particular, the study evaluated the question of whether the neurons studied are most sensitive to the maximum level of linear acceleration achieved or to the rate of change in acceleration (da/dt, or jerk). To do this, vestibular response thresholds were measured as a function of stimulus onset slope. Traditional computer signal averaging was used to record responses to pulsed linear acceleration stimuli. Stimulus onset slope was systematically varied. Acceleration thresholds decreased with increasing stimulus onset slope (decreasing stimulus rise time). When stimuli were expressed in units of jerk (g/ms), thresholds were virtually constant for all stimulus rise times. Moreover, stimuli having identical jerk magnitudes but widely varying peak acceleration levels produced virtually identical responses. Vestibular response thresholds, latencies and amplitudes appear to be determined strictly by stimulus jerk magnitudes. Stimulus attributes such as peak acceleration or rise time alone do not provide sufficient information to predict response parameter quantities. Indeed, the major response parameters were shown to be virtually independent of peak acceleration levels or rise time when these stimulus features were isolated and considered separately. It is concluded that the neurons generating short latency vestibular evoked potentials do so as "jerk encoders" in the chicken. Primary afferents classified as "irregular", and which traditionally fall into the broad category of "dynamic" or "phasic" neurons, would seem to be the most likely candidates for the neural generators of short latency vestibular compound action potentials.

  14. Emotional Experiences of Obese Women with Adequate Gestational Weight Variation: A Qualitative Study

    PubMed Central

    Faria-Schützer, Débora Bicudo; Surita, Fernanda Garanhani de Castro; Alves, Vera Lucia Pereira; Vieira, Carla Maria; Turato, Egberto Ribeiro

    2015-01-01

    Background As a result of the growth of the obese population, the number of obese women of fertile age has increased in the last few years. Obesity in pregnancy is related to greater levels of anxiety, depression and physical harm. However, pregnancy is an opportune moment for the intervention of health care professionals to address obesity. The objective of this study was to describe how obese pregnant women emotionally experience success in adequate weight control. Methods and Findings Using a qualitative design that seeks to understand content in the field of health, the sample of subjects was deliberated, with thirteen obese pregnant women selected to participate in an individual interview. Data was analysed by inductive content analysis and includes complete transcription of the interviews, re-readings using suspended attention, categorization in discussion topics and the qualitative and inductive analysis of the content. The analysis revealed four categories, three of which show the trajectory of body care that obese women experience during pregnancy: 1) The obese pregnant woman starts to think about her body;2) The challenge of the diet for the obese pregnant woman; 3) The relation of the obese pregnant woman with the team of antenatal professionals. The fourth category reveals the origin of the motivation for the change: 4) The potentializing factors for change: the motivation of the obese woman while pregnant. Conclusions During pregnancy, obese women are more in touch with themselves and with their emotional conflicts. Through the transformations of their bodies, women can start a more refined self-care process and experience of the body-mind unit. The fear for their own and their baby's life, due to the risks posed by obesity, appears to be a great potentializing factor for change. The relationship with the professionals of the health care team plays an important role in the motivational support of the obese pregnant woman. PMID:26529600

  15. The rat adequately reflects human responses to exercise in blood biochemical profile: a comparative study

    PubMed Central

    Goutianos, Georgios; Tzioura, Aikaterini; Kyparos, Antonios; Paschalis, Vassilis; Margaritelis, Nikos V; Veskoukis, Aristidis S; Zafeiridis, Andreas; Dipla, Konstantina; Nikolaidis, Michalis G; Vrabas, Ioannis S

    2015-01-01

    Animal models are widely used in biology and the findings of animal research are traditionally projected to humans. However, recent publications have raised concerns with regard to what extent animals and humans respond similar to physiological stimuli. Original data on direct in vivo comparison between animals and humans are scarce and no study has addressed this issue after exercise. We aimed to compare side by side in the same experimental setup rat and human responses to an acute exercise bout of matched intensity and duration. Rats and humans ran on a treadmill at 86% of maximal velocity until exhaustion. Pre and post exercise we measured 30 blood chemistry parameters, which evaluate iron status, lipid profile, glucose regulation, protein metabolism, liver, and renal function. ANOVA indicated that almost all biochemical parameters followed a similar alteration pattern post exercise in rats and humans. In fact, there were only 2/30 significant species × exercise interactions (in testosterone and globulins), indicating different responses to exercise between rats and humans. On the contrary, the main effect of exercise was significant in 15/30 parameters and marginally nonsignificant in other two parameters (copper, P = 0.060 and apolipoprotein B, P = 0.058). Our major finding is that the rat adequately mimics human responses to exercise in those basic blood biochemical parameters reported here. The physiological resemblance of rat and human blood responses after exercise to exhaustion on a treadmill indicates that the use of blood chemistry in rats for exercise physiology research is justified. PMID:25677548

  16. Investigators' viewpoint of clinical trials in India: Past, present and future.

    PubMed

    Mallath, Mohandas K; Chawla, Tanuj

    2017-01-01

    India's success in producing food and milk for its population (Green Revolution and White Revolution) happened because of scientific research and field trials. Likewise improving the health of Indians needs clinical research and clinical trials. A Large proportion of the sick Indians are poor, illiterate with no access to good health care. They are highly vulnerable to inducement and exploitation in clinical trials. The past two decades saw the rise and fall of clinical trials in India. The rise happened when our regulators created a favorable environment, and Indian investigators were invited to participate in global clinical trials. The gap between the demand and supply resulted in inadequate protection of the trial participants. Reports of abuses of the vulnerable trial participants followed by public interest litigations led to strengthening of regulations by the regulators. The stringent new regulations made the conduct of clinical trials more laborious and increased the cost of clinical trials in India. There was a loss of interest in sponsored clinical trials resulting in the fall in global clinical trials in India. Following repeated appeals by the investigators, the Indian regulators have recently relaxed some of the stringent regulations, while continuing to ensure the adequate patient protection. Clinical trials that are relevant to our population and conducted by well-trained investigators and monitored by trained and registered Ethics Committees will increase in the future. We must remain vigilant, avoid previous mistakes, and strive hard to protect the trial participants in the future trials.

  17. Investigators' viewpoint of clinical trials in India: Past, present and future

    PubMed Central

    Mallath, Mohandas K.; Chawla, Tanuj

    2017-01-01

    India's success in producing food and milk for its population (Green Revolution and White Revolution) happened because of scientific research and field trials. Likewise improving the health of Indians needs clinical research and clinical trials. A Large proportion of the sick Indians are poor, illiterate with no access to good health care. They are highly vulnerable to inducement and exploitation in clinical trials. The past two decades saw the rise and fall of clinical trials in India. The rise happened when our regulators created a favorable environment, and Indian investigators were invited to participate in global clinical trials. The gap between the demand and supply resulted in inadequate protection of the trial participants. Reports of abuses of the vulnerable trial participants followed by public interest litigations led to strengthening of regulations by the regulators. The stringent new regulations made the conduct of clinical trials more laborious and increased the cost of clinical trials in India. There was a loss of interest in sponsored clinical trials resulting in the fall in global clinical trials in India. Following repeated appeals by the investigators, the Indian regulators have recently relaxed some of the stringent regulations, while continuing to ensure the adequate patient protection. Clinical trials that are relevant to our population and conducted by well-trained investigators and monitored by trained and registered Ethics Committees will increase in the future. We must remain vigilant, avoid previous mistakes, and strive hard to protect the trial participants in the future trials. PMID:28194335

  18. Measurements of experimental precision for trials with cowpea (Vigna unguiculata L. Walp.) genotypes.

    PubMed

    Teodoro, P E; Torres, F E; Santos, A D; Corrêa, A M; Nascimento, M; Barroso, L M A; Ceccon, G

    2016-05-09

    The aim of this study was to evaluate the suitability of statistics as experimental precision degree measures for trials with cowpea (Vigna unguiculata L. Walp.) genotypes. Cowpea genotype yields were evaluated in 29 trials conducted in Brazil between 2005 and 2012. The genotypes were evaluated with a randomized block design with four replications. Ten statistics that were estimated for each trial were compared using descriptive statistics, Pearson correlations, and path analysis. According to the class limits established, selective accuracy and F-test values for genotype, heritability, and the coefficient of determination adequately estimated the degree of experimental precision. Using these statistics, 86.21% of the trials had adequate experimental precision. Selective accuracy and the F-test values for genotype, heritability, and the coefficient of determination were directly related to each other, and were more suitable than the coefficient of variation and the least significant difference (by the Tukey test) to evaluate experimental precision in trials with cowpea genotypes.

  19. Types of Treatment: Clinical Trials

    MedlinePlus

    ... Clinical Trial Service: LLS provides personalized clinical trial navigation when appropriate. For more information, please contact an ... trial. We can also provide personalized clinical trial navigation when appropriate. Related Links For video clips answering ...

  20. Power options for lunar exploration

    SciTech Connect

    Bamberger, J.A.; Gaustad, K.L.

    1992-01-01

    This paper presents an overview of the types of power systems available for providing power on the moon. Lunar missions of exploration, in situ resource utilization, and colonization will be constrained by availability of adequate power. The length of the lunar night places severe limitations on solar power system designs, because a large portion of the system mass is devoted to energy storage. The selection of the ideal power source hardware will require compatibility with not only the lunar base power requirements and environment, but also with the conversion, storage, and transmission equipment. In addition, further analysis to determine the optimum operating parameters for a given power system should be conducted so that critical technologies can be identified in the early stages of base development. This paper describes the various concepts proposed for providing power on the lunar surface and compare their ranges of applicability. The importance of a systems approach to the integration of these components will also be discussed.

  1. Optimizing the Use of Aripiprazole Augmentation in the Treatment of Major Depressive Disorder: From Clinical Trials to Clinical Practice.

    PubMed

    Han, Changsu; Wang, Sheng-Min; Lee, Soo-Jung; Jun, Tae-Youn; Pae, Chi-Un

    2015-08-01

    Major depressive disorder (MDD) is a recurrent, chronic, and devastating disorder leading to serious impairment in functional capacity as well as increasing public health care costs. In the previous decade, switching therapy and dose adjustment of ongoing antidepressants was the most frequently chosen subsequent treatment option for MDD. However, such recommendations were not based on firmly proven efficacy data from well-designed, placebo-controlled, randomized clinical trials (RCTs) but on practical grounds and clinical reasoning. Aripiprazole augmentation has been dramatically increasing in clinical practice owing to its unique action mechanisms as well as proven efficacy and safety from adequately powered and well-controlled RCTs. Despite the increased use of aripiprazole in depression, limited clinical information and knowledge interfere with proper and efficient use of aripiprazole augmentation for MDD. The objective of the present review was to enhance clinicians' current understanding of aripiprazole augmentation and how to optimize the use of this therapy in the treatment of MDD.

  2. Optimizing the Use of Aripiprazole Augmentation in the Treatment of Major Depressive Disorder: From Clinical Trials to Clinical Practice

    PubMed Central

    Han, Changsu; Wang, Sheng-Min; Lee, Soo-Jung; Jun, Tae-Youn

    2015-01-01

    Major depressive disorder (MDD) is a recurrent, chronic, and devastating disorder leading to serious impairment in functional capacity as well as increasing public health care costs. In the previous decade, switching therapy and dose adjustment of ongoing antidepressants was the most frequently chosen subsequent treatment option for MDD. However, such recommendations were not based on firmly proven efficacy data from well-designed, placebo-controlled, randomized clinical trials (RCTs) but on practical grounds and clinical reasoning. Aripiprazole augmentation has been dramatically increasing in clinical practice owing to its unique action mechanisms as well as proven efficacy and safety from adequately powered and well-controlled RCTs. Despite the increased use of aripiprazole in depression, limited clinical information and knowledge interfere with proper and efficient use of aripiprazole augmentation for MDD. The objective of the present review was to enhance clinicians' current understanding of aripiprazole augmentation and how to optimize the use of this therapy in the treatment of MDD. PMID:26306301

  3. Smart Technology in Lung Disease Clinical Trials.

    PubMed

    Geller, Nancy L; Kim, Dong-Yun; Tian, Xin

    2016-01-01

    This article describes the use of smart technology by investigators and patients to facilitate lung disease clinical trials and make them less costly and more efficient. By "smart technology" we include various electronic media, such as computer databases, the Internet, and mobile devices. We first describe the use of electronic health records for identifying potential subjects and then discuss electronic informed consent. We give several examples of using the Internet and mobile technology in clinical trials. Interventions have been delivered via the World Wide Web or via mobile devices, and both have been used to collect outcome data. We discuss examples of new electronic devices that recently have been introduced to collect health data. While use of smart technology in clinical trials is an exciting development, comparison with similar interventions applied in a conventional manner is still in its infancy. We discuss advantages and disadvantages of using this omnipresent, powerful tool in clinical trials, as well as directions for future research.

  4. The Effects of Verbal Skills on Trial Success.

    ERIC Educational Resources Information Center

    Parkinson, Michael G.; And Others

    1983-01-01

    Applied Syntactic Language Computer Analysis and counts of legal jargon and power speech to analyze the language styles of plaintiffs, defendants, and attorneys in 20 civil trials. Concluded that successful trial participants speak differently than those who fail and that the differences in language style are significant and consistent. (PD)

  5. Effect of respiratory warm-up on anaerobic power.

    PubMed

    Özdal, Mustafa; Bostanci, Özgür; Dağlioğlu, Önder; Ağaoğlu, Seydi Ahmet; Kabadayi, Menderes

    2016-07-01

    [Purpose] The aim of the present study was to examine the effects of respiratory muscle warm-up on anaerobic power. [Subjects and Methods] Thirty male field hockey players (age, 20.5 ± 2.0 years) each participated in a control (CAN) trial and an experimental (EAN) trial. The EAN trial involved respiratory muscle warm-up, while the CAN trial did not. Anaerobic power was measured using the Wingate protocol. Paired sample t-tests were used to compare the EAN and CAN trials. [Results] There were significant increases in peak power and relative peak power, and decreases in the time to peak after the EAN trial by 8.9%, 9.6%, and 28.8% respectively. [Conclusion] Respiratory muscle warm-up may positively affect anaerobic power due to faster attainment of peak power.

  6. Effect of respiratory warm-up on anaerobic power

    PubMed Central

    Özdal, Mustafa; Bostanci, Özgür; Dağlioğlu, Önder; Ağaoğlu, Seydi Ahmet; Kabadayi, Menderes

    2016-01-01

    [Purpose] The aim of the present study was to examine the effects of respiratory muscle warm-up on anaerobic power. [Subjects and Methods] Thirty male field hockey players (age, 20.5 ± 2.0 years) each participated in a control (CAN) trial and an experimental (EAN) trial. The EAN trial involved respiratory muscle warm-up, while the CAN trial did not. Anaerobic power was measured using the Wingate protocol. Paired sample t-tests were used to compare the EAN and CAN trials. [Results] There were significant increases in peak power and relative peak power, and decreases in the time to peak after the EAN trial by 8.9%, 9.6%, and 28.8% respectively. [Conclusion] Respiratory muscle warm-up may positively affect anaerobic power due to faster attainment of peak power. PMID:27512273

  7. The Virtual Trial

    PubMed Central

    de Haan, Willem

    2017-01-01

    Although brain network analysis in neurodegenerative disease is still a fairly young discipline, expectations are high. The robust theoretical basis, the straightforward detection and explanation of otherwise intangible complex system phenomena, and the correlations of network features with pathology and cognitive status are qualities that show the potential power of this new instrument. We expect “connectomics” to eventually better explain and predict that essential but still poorly understood aspect of dementia: the relation between pathology and cognitive symptoms. But at this point, our newly acquired knowledge has not yet translated into practical methods or applications in the medical field, and most doctors regard brain connectivity analysis as a wonderful but exotic research niche that is too technical and abstract to benefit patients directly. This article aims to provide a personal perspective on how brain connectivity research may get closer to obtaining a clinical role. I will argue that network intervention modeling, which unites the strengths of network analysis and computational modeling, is a great candidate for this purpose, as it can offer an attractive test environment in which positive and negative influences on network integrity can be explored, with the ultimate aim to find effective countermeasures against neurodegenerative network damage. The virtual trial approach might become what both dementia and connectivity researchers have been waiting for: a versatile tool that turns our growing connectome knowledge into clinical predictions. PMID:28326011

  8. Imaging surveillance programs for women at high breast cancer risk in Europe: Are women from ethnic minority groups adequately included? (Review).

    PubMed

    Belkić, Karen; Cohen, Miri; Wilczek, Brigitte; Andersson, Sonia; Berman, Anne H; Márquez, Marcela; Vukojević, Vladana; Mints, Miriam

    2015-09-01

    Women from ethnic minority groups, including immigrants and refugees are reported to have low breast cancer (BC) screening rates. Active, culturally-sensitive outreach is vital for increasing participation of these women in BC screening programs. Women at high BC risk and who belong to an ethnic minority group are of special concern. Such women could benefit from ongoing trials aimed at optimizing screening strategies for early BC detection among those at increased BC risk. Considering the marked disparities in BC survival in Europe and its enormous and dynamic ethnic diversity, these issues are extremely timely for Europe. We systematically reviewed the literature concerning European surveillance studies that had imaging in the protocol and that targeted women at high BC risk. The aim of the present review was thereby to assess the likelihood that women at high BC risk from minority ethnic groups were adequately included in these surveillance programs. Twenty-seven research groups in Europe reported on their imaging surveillance programs for women at increased BC risk. The benefit of strategies such as inclusion of magnetic resonance imaging and/or more intensive screening was clearly documented for the participating women at increased BC risk. However, none of the reports indicated that sufficient outreach was performed to ensure that women at increased BC risk from minority ethnic groups were adequately included in these surveillance programs. On the basis of this systematic review, we conclude that the specific screening needs of ethnic minority women at increased BC risk have not yet been met in Europe. Active, culturally-sensitive outreach is needed to identify minority women at increased BC risk and to facilitate their inclusion in on-going surveillance programs. It is anticipated that these efforts would be most effective if coordinated with the development of European-wide, population-based approaches to BC screening.

  9. Planning 4-Dimensional Computed Tomography (4DCT) Cannot Adequately Represent Daily Intrafractional Motion of Abdominal Tumors

    SciTech Connect

    Ge, Jiajia; Santanam, Lakshmi; Noel, Camille; Parikh, Parag J.

    2013-03-15

    Purpose: To evaluate whether planning 4-dimensional computed tomography (4DCT) can adequately represent daily motion of abdominal tumors in regularly fractionated and stereotactic body radiation therapy (SBRT) patients. Methods and Materials: Intrafractional tumor motion of 10 patients with abdominal tumors (4 pancreas-fractionated and 6 liver-stereotactic patients) with implanted fiducials was measured based on daily orthogonal fluoroscopic movies over 38 treatment fractions. The needed internal margin for at least 90% of tumor coverage was calculated based on a 95th and fifth percentile of daily 3-dimensional tumor motion. The planning internal margin was generated by fusing 4DCT motion from all phase bins. The disagreement between needed and planning internal margin was analyzed fraction by fraction in 3 motion axes (superior-inferior [SI], anterior-posterior [AP], and left-right [LR]). The 4DCT margin was considered as an overestimation/underestimation of daily motion when disagreement exceeded at least 3 mm in the SI axis and/or 1.2 mm in the AP and LR axes (4DCT image resolution). The underlying reasons for this disagreement were evaluated based on interfractional and intrafractional breathing variation. Results: The 4DCT overestimated daily 3-dimensional motion in 39% of the fractions in 7 of 10 patients and underestimated it in 53% of the fractions in 8 of 10 patients. Median underestimation was 3.9 mm, 3.0 mm, and 1.7 mm in the SI axis, AP axis, and LR axis, respectively. The 4DCT was found to capture irregular deep breaths in 3 of 10 patients, with 4DCT motion larger than mean daily amplitude by 18 to 21 mm. The breathing pattern varied from breath to breath and day to day. The intrafractional variation of amplitude was significantly larger than intrafractional variation (2.7 mm vs 1.3 mm) in the primary motion axis (ie, SI axis). The SBRT patients showed significantly larger intrafractional amplitude variation than fractionated patients (3.0 mm vs 2

  10. Perinatal substance abuse and human subjects research: are privacy protections adequate?

    PubMed

    Marshall, Mary Faith; Menikoff, Jerry; Paltrow, Lynn M

    2003-01-01

    moral responsibility to understand local, state and national policies and laws governing perinatal substance abuse. Investigators and IRB members should balance the harms of punitive interventions against the protections that may, or may not be afforded to prospective research subjects as well as the prospective benefits, individual and social, of the research. In situations where criminal or punitive policies are in effect, investigators and IRB members should consider whether adequate protections can be achieved. In the context of inadequate protections, potential risks to prospective research subjects and their families may outweigh the individual or social benefits that accrue from the research. Clinical researchers are professionally obligated to work toward amending laws and policies that are not in the best interests of prospective research subjects.

  11. Pharmacological Treatment of Alzheimer’s Disease: Is it Progressing Adequately?

    PubMed Central

    Robles, Alfredo

    2009-01-01

    Introduction: Between 1993 and 2000 four acetylcholinesterase inhibitors were marketed as a symptomatic treatment for Alzheimer’s disease (AD), as well as memantine in 2003. Current research is focused on finding drugs that favorably modify the course of the disease. However, their entrance into the market does not seem to be imminent. Research Development: The aim of AD research is to find substances that inhibit certain elements of the AD pathogenic chain (beta- and gamma-secretase inhibitors, alpha-secretase stimulants, beta-amyloid aggregability reducers or disaggregation and elimination inductors, as well as tau-hyperphosphorylation, glutamate excitotoxicity, oxidative stress and mitochondrial damage reducers, among other action mechanisms). Demonstrating a disease’s retarding effect demands longer trials than those necessary to ascertain symptomatic improvement. Besides, a high number of patients (thousands of them) is necessary, all of which turns out to be difficult and costly. Furthermore, it would be necessary to count on diagnosis and progression markers in the disease’s pre-clinical stage, markers for specific phenotypes, as well as high-selectivity molecules acting only where necessary. In order to compensate these difficulties, drugs acting on several defects of the pathogenic chain or showing both symptomatic and neuroprotective action simultaneously are being researched. Conclusions: There are multiple molecules used in research to modify AD progression. Although it turns out to be difficult to obtain drugs with sufficient efficacy so that their marketing is approved, if they were achieved they would lead to a reduction of AD prevalence. PMID:19461897

  12. Can exercise improve self esteem in children and young people? A systematic review of randomised controlled trials

    PubMed Central

    Ekeland, E; Heian, F; Hagen, K; Coren, E

    2005-01-01

    Twenty three randomised controlled trials were analysed. A synthesis of several small, low quality trials indicates that exercise may have short term beneficial effects on self esteem in children and adolescents. However, high quality research on defined populations with adequate follow up is needed. PMID:16244186

  13. Assessing laboratory performance in Trichinella ring trials.

    PubMed

    Petroff, David; Hasenclever, Dirk; Makrutzki, Gregor; Riehn, Katharina; Lücker, Ernst

    2014-08-01

    Trichinosis (Trichinellosis) is a zoonotic disease acquired by eating raw or not adequately processed pork or wild game infected with the larvae of the roundworm genus Trichinella. According to European regulations, animals susceptible to Trichinella have to be examined for infestation. To evaluate the performance of laboratories in Germany, inter-laboratory comparisons known as "ring trials" were introduced by the Federal Institute for Risk Assessment in 2004. The current method of analysis makes use of tolerance zones based on the number of larvae in the sample, but does not permit one to determine if a given lab can detect an infested sample reliably, as required by the quality assurance recommendations of the International Commission on Trichinellosis (ICT). A new way of analysing the ring trial data is presented here, which is based on Bayesian hierarchical models. The model implements the ICT requirement by providing an estimate for the probability that a given lab would fail to detect a sample containing, say, five larvae. When applied to the 87 labs that participated in Germany's 2009 ring trials, it turns out this probability is greater than 10% for 21 of them, although only 10 of these in fact returned a false negative result. Such a new method is required to abide by the ICT requirements and make ring trials effective.

  14. The challenges and opportunities of conducting a clinical trial in a low resource setting: the case of the Cameroon mobile phone SMS (CAMPS) trial, an investigator initiated trial.

    PubMed

    Mbuagbaw, Lawrence; Thabane, Lehana; Ongolo-Zogo, Pierre; Lang, Trudie

    2011-06-09

    Conducting clinical trials in developing countries often presents significant ethical, organisational, cultural and infrastructural challenges to researchers, pharmaceutical companies, sponsors and regulatory bodies. Globally, these regions are under-represented in research, yet this population stands to gain more from research in these settings as the burdens on health are greater than those in developed resourceful countries. However, developing countries also offer an attractive setting for clinical trials because they often have larger treatment naive populations with higher incidence rates of disease and more advanced stages. These factors can present a reduction in costs and time required to recruit patients. So, balance needs to be found where research can be encouraged and supported in order to bring maximum public health benefits to these communities. The difficulties with such trials arise from problems with obtaining valid informed consent, ethical compensation mechanisms for extremely poor populations, poor health infrastructure and considerable socio-economic and cultural divides. Ethical concerns with trials in developing countries have received attention, even though many other non-ethical issues may arise. Local investigator initiated trials also face a variety of difficulties that have not been adequately reported in literature. This paper uses the example of the Cameroon Mobile Phone SMS trial to describe in detail, the specific difficulties encountered in an investigator-initiated trial in a developing country. It highlights administrative, ethical, financial and staff related issues, proposes solutions and gives a list of additional documentation to ease the organisational process.

  15. From trial and error to trial simulation. Part 2: an appraisal of current beliefs in the design and analysis of clinical trials for antidepressant drugs.

    PubMed

    Santen, G; Horrigan, J; Danhof, M; Della Pasqua, O

    2009-09-01

    Study design factors are partly to blame for the high failure rate in trials with antidepressant drugs. Clinical trial simulation (CTS) allows the investigation of the influence of design characteristics on important aspects of clinical trials such as power and type I error. Using CTS scenarios, we evaluated the impact of population size, randomization ratio, frequency of assessments, dropout mechanisms, clinical end point, and statistical method on the outcome of clinical trials with antidepressant drugs. The results reveal that (i) an increase in the frequency of visits does not increase statistical power, (ii) a skewed randomization for a placebo or comparator arm may decrease statistical power, and (iii) analysis of the percentage of responders should be avoided. CTS should become best practice in the optimization of study design. To date, no other statistical approach has enabled such comprehensive evaluation of the factors contributing to study failure in depression.

  16. How to Evaluate Phase Differences between Trial Groups in Ongoing Electrophysiological Signals

    PubMed Central

    VanRullen, Rufin

    2016-01-01

    A growing number of studies endeavor to reveal periodicities in sensory and cognitive functions, by comparing the distribution of ongoing (pre-stimulus) oscillatory phases between two (or more) trial groups reflecting distinct experimental outcomes. A systematic relation between the phase of spontaneous electrophysiological signals, before a stimulus is even presented, and the eventual result of sensory or cognitive processing for that stimulus, would be indicative of an intrinsic periodicity in the underlying neural process. Prior studies of phase-dependent perception have used a variety of analytical methods to measure and evaluate phase differences, and there is currently no established standard practice in this field. The present report intends to remediate this need, by systematically comparing the statistical power of various measures of “phase opposition” between two trial groups, in a number of real and simulated experimental situations. Seven measures were evaluated: one parametric test (circular Watson-Williams test), and three distinct measures of phase opposition (phase bifurcation index, phase opposition sum, and phase opposition product) combined with two procedures for non-parametric statistical testing (permutation, or a combination of z-score and permutation). While these are obviously not the only existing or conceivable measures, they have all been used in recent studies. All tested methods performed adequately on a previously published dataset (Busch et al., 2009). On a variety of artificially constructed datasets, no single measure was found to surpass all others, but instead the suitability of each measure was contingent on several experimental factors: the time, frequency, and depth of oscillatory phase modulation; the absolute and relative amplitudes of post-stimulus event-related potentials for the two trial groups; the absolute and relative trial numbers for the two groups; and the number of permutations used for non-parametric testing

  17. Terrain commander UGS operational trials

    NASA Astrophysics Data System (ADS)

    Steadman, Robert L.

    2004-09-01

    Operational trials of Textron Systems" Terrain Commander unattended ground sensor (UGS) system are described. Terrain Commander is a powerful new concept in surveillance and remote situational awareness. It leverages a diverse suite of sophisticated unattended ground sensors, day/night electro-optics, satellite data communications, and an advanced Windows based graphic user interface. Terrain Commander OASIS (Optical Acoustic SATCOM Integrated Sensor) provides next generation target detection, classification, and tracking through smart sensor fusion of beam-forming acoustic, seismic, passive infrared, and magnetic sensors. With its fully integrated SATCOM system using internet protocols, virtually any site in the world can be monitored from almost any other location. Multiple remote sites such as airfields, landing zones, base perimeters, road junctions, flanks, and border crossings are monitored with ease from a central location. Intruding personnel or vehicles are automatically detected, classified, and imaged. Results from early operational trials in the outback of Australia and in various locations in the US are described. Probability of detection and recognition against a wide variety of targets including personnel, military and civilian vehicles, in-shore watercraft, and low altitude aircraft are discussed. Environments include snow cover, tropical savannah, rainforest, and woodlands. Experience with alternative SATCOM systems during the trials is also touched upon.

  18. Optimization of pharmacotherapy in chronic heart failure: is heart rate adequately addressed?

    PubMed

    Franke, Jennifer; Wolter, Jan Sebastian; Meme, Lillian; Keppler, Jeannette; Tschierschke, Ramon; Katus, Hugo A; Zugck, Christian

    2013-01-01

    bpm (p <0.01). Likewise, comparing the groups ≥75 and <75 bpm, the primary endpoint was significantly increased in the group of patients with heart rates ≥75 bpm 27 vs. 12.2 %; p < 0.01). 5-year event-free survival was significantly lower among patients with heart rates ≥70 bpm as compared to those with <70 bpm (log-rank test p < 0.05) and among patients in the ≥75 bpm group versus <75 bpm group (log-rank test p < 0.01). In conclusion, in clinical practice, 53 % of CHF patients have inadequate heart rate control (heart rates ≥75 bpm) despite concomitant beta-blocker therapy. In this non-randomized cohort, adequate heart rate control under individually optimized beta-blocker therapy was associated with improved mid- and long-term clinical outcome up to 5 years. As further up titration of beta-blockers is not achievable in many patients, the administration of a selective heart rate lowering agent, such as ivabradine adjuvant to beta-blockers may pose an opportunity to further modulate outcome.

  19. Power considerations for the application of detrended fluctuation analysis in gait variability studies

    PubMed Central

    Kuznetsov, Nikita A.; Rhea, Christopher K.

    2017-01-01

    The assessment of gait variability using stochastic signal processing techniques such as detrended fluctuation analysis (DFA) has been shown to be a sensitive tool for evaluation of gait alterations due to aging and neuromuscular disease. However, previous studies have suggested that the application of DFA requires relatively long recordings (600 strides), which is difficult when working with clinical populations or older adults. In this paper we propose a model for predicting DFA variance in experimental data and conduct a Monte Carlo simulation to estimate the sample size and number of trials required to detect a change in DFA scaling exponent. We illustrate the model in a simulation to detect a difference of 0.1 (medium effect) between two groups of subjects when using short gait time series (100 to 200 strides) in the context of between- and within-subject designs. We assumed that the variance of DFA scaling exponent arises due to individual differences, time series length, and experimental error. Results showed that sample sizes required to achieve acceptable power of 80% are practically feasible, especially when using within-subject designs. For example, to detect a group difference in the DFA scaling exponent of 0.1, it would require either 25 subjects and 2 trials per subject or 12 subjects and 4 trials per subject using a within-subject design. We then compared plausibility of such power predictions to the empirically observed power from a study that required subjects to synchronize with a persistent fractal metronome. The results showed that the model adequately predicted the empirical pattern of results. Our power simulations could be used in conjunction with previous design guidelines in the literature when planning new gait variability experiments. PMID:28323871

  20. [CLINICAL TRIAL DESIGN].

    PubMed

    Morita, Satoshi

    2016-01-01

    Clinical trials/research are conducted to examine the clinical questions of practicing physicians. It is important to design trials appropriately in advance, taking their feasibility into account. A randomized, controlled trial is the ultimate design for treatment comparisons at the final confirmatory stage. However, randomized trials do not necessarily provide all answers to clinical questions. This article summarizes fundamental points of clinical trial design and the important role of randomization and contrasts superiority and noninferiority trials. In addition, it focuses on propensity score matching, a useful method to compare two treatment arms, especially in the context where randomization is infeasible. The propensity score-matching method is increasingly used in surgical clinical research.

  1. Design of clinical trials.

    PubMed

    Rollo, David; Machado, Sanjay; Ceschin, Mauro

    2010-09-01

    Clinical trial design for nuclear medicine diagnostic imaging radiopharmaceuticals must include a design for preclinical safety studies. These studies should establish that the investigational product (IP) does not have a toxic effect. As a further requirement, radiopharmaceutical clinical trials include a human study (phase 1) that provides biodistribution, pharmacokinetics, and radiation dosimetry information. These studies demonstrate to the Food and Drug Administration that the IP either meets or exceeds the toxicology and radiation exposure safety limits. Satisfying this requirement can result in the Food and Drug Administration approving the performance of late-phase (phase 2/3) clinical trials that are designed to validate the clinical efficacy of the diagnostic imaging agent in patients who have a confirmed diagnosis for the intended application. Emphasis is placed on the most typical trial design for diagnostic imaging agents that use a comparator to demonstrate that the new IP is similar in efficacy to an established standard comparator. Such trials are called equivalence, or noninferiority, trials that attempt to show that the new IP is not less effective than the comparator by more than a statistically defined amount. Importantly, the trial design must not inappropriately favor one diagnostic imaging agent over the other. Bias is avoided by the use of a core laboratory with expert physicians who are not involved in the trial for interpreting and objectively scoring the image sets obtained at the clinical trial sites. Clinical trial design must also follow Good Clinical Practice (GCP) guidelines. GCP stipulates the clinical trial process, including protocol and Case Report Form design, analyses planning, as well as analyzing and preparing interim and final clinical trial/study reports.

  2. Increased calcium absorption from synthetic stable amorphous calcium carbonate: Double-blind randomized crossover clinical trial in post-menopausal women

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Calcium supplementation is a widely recognized strategy for achieving adequate calcium intake. We designed this blinded, randomized, crossover interventional trial to compare the bioavailability of a new stable synthetic amorphous calcium carbonate (ACC) with that of crystalline calcium carbonate (C...

  3. Macronutrient Supplementation for Malnourished HIV-infected Adults: A Review of the Evidence in Resource-Adequate and Resource-Constrained Settings

    PubMed Central

    Koethe, John R.; Chi, Benjamin H.; Megazzini, Karen M.; Heimburger, Douglas C.; Stringer, Jeffrey S. A.

    2011-01-01

    Access to antiretroviral therapy (ART) for HIV infection has expanded rapidly throughout sub-Saharan Africa, but malnutrition and food insecurity have emerged as major barriers to program success. Protein-calorie malnutrition (a common form in the region) hastens HIV disease progression, and food insecurity is a barrier to medication adherence. Analyses of patient outcomes have identified a low body mass index (BMI) at ART initiation as an independent predictor of early mortality, but the causes of low BMI are multi-factorial may represent normal anthropometric variation, chronic inadequate food intake, or wasting associated with HIV and other infections. While there is much experience population-level humanitarian food assistance, few data exist to measure the effectiveness of macronutrient supplementation or to identify individuals most likely to benefit. In this report, we review the current evidence supporting macronutrient supplementation for HIV-infected adults; clinical trials in resource-adequate and resource-constrained settings; and highlight priority areas for future research. PMID:19624276

  4. Solar Power Satellite (SPS) solid-state antenna power combiner

    NASA Technical Reports Server (NTRS)

    1980-01-01

    A low loss power-combining microstrip antenna suitable for solid state solar power satellite (SPS) application was developed. A unique approach for performing both the combining and radiating function in a single cavity-type circuit was verified, representing substantial refinements over previous demonstration models in terms of detailed geometry to obtain good matching and adequate bandwidth at the design frequency. The combiner circuit was designed, built, and tested and the overall results support the view that the solid state power-combining antenna approach is a viable candidate for a solid state SPS antenna building block.

  5. Adequate Funding of Education Programs for At-Risk Children: An Econometric Application of Research-Based Cost Differentials

    ERIC Educational Resources Information Center

    Alexander, Kern; Wall, Andrew

    2006-01-01

    This article contributes to the ongoing discussion of the adequacy of funding for public schools, specifically with regard to the provision of programs for at-risk children. Of particular concern is the determination of realistic, research-based costs of adequately funded programs. This article has three basic parts: the definition and measurement…

  6. Cognitive Attributes, Attention, and Self-Efficacy of Adequate and Inadequate Responders in a Fourth Grade Reading Intervention

    ERIC Educational Resources Information Center

    Cho, Eunsoo; Roberts, Garrett J.; Capin, Philip; Roberts, Greg; Miciak, Jeremy; Vaughn, Sharon

    2015-01-01

    We examined cognitive attributes, attention, and self-efficacy of fourth grade struggling readers who were identified as adequate responders (n = 27), inadequate responders with comprehension only deficits (n = 46), and inadequate responders with comprehension and word reading deficits (n = 52) after receiving a multicomponent reading…

  7. Understanding Unresponsiveness to Tier 2 Reading Intervention: Exploring the Classification and Profiles of Adequate and Inadequate Responders in First Grade

    ERIC Educational Resources Information Center

    Toste, Jessica R.; Compton, Donald L.; Fuchs, Douglas; Fuchs, Lynn S.; Gilbert, Jennifer K.; Cho, Eunsoo; Barquero, Laura A.; Bouton, Bobette D.

    2014-01-01

    The purpose of the current study was to examine academic and cognitive profiles of first graders who responded adequately and inadequately to intensive small-group reading intervention (Tier 2), as well as assess how these profiles differ based on the criteria used for classification of unresponsiveness. Nonresponders were identified using two…

  8. 45 CFR 2508.10 - Who has the responsibility for maintaining adequate technical, physical, and security safeguards...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... record systems. These security safeguards shall apply to all systems in which identifiable personal data... the security and privacy of such records. (7) The disposal and destruction of records within a system... adequate technical, physical, and security safeguards to prevent unauthorized disclosure or destruction...

  9. Using Fuzzy Logic to Identify Schools Which May Be Misclassified by the No Child Left Behind Adequate Yearly Progress Policy

    ERIC Educational Resources Information Center

    Yates, Donald W.

    2009-01-01

    This investigation developed, tested, and prototyped a Fuzzy Inference System (FIS) that would assist decision makers in identifying schools that may have been misclassified by existing Adequate Yearly Progress (AYP) methods. This prototype was then used to evaluate Louisiana elementary schools using published school data for Academic Year 2004. …

  10. 21 CFR 1.283 - What happens to food that is imported or offered for import without adequate prior notice?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Prior Notice of... adequate prior notice? (a) For each article of food that is imported or offered for import into the United... individual, the consequences are: (1) Inadequate prior notice—(i) No prior notice. If an article of...

  11. Are Substance Use Prevention Programs More Effective in Schools Making Adequate Yearly Progress? A Study of Project ALERT

    ERIC Educational Resources Information Center

    Clark, Heddy Kovach; Ringwalt, Chris L.; Shamblen, Stephen R.; Hanley, Sean M.; Flewelling, Robert L.

    2011-01-01

    This exploratory study sought to determine if a popular school-based drug prevention program might be effective in schools that are making adequate yearly progress (AYP). Thirty-four schools with grades 6 through 8 in 11 states were randomly assigned either to receive Project ALERT (n = 17) or to a control group (n = 17); of these, 10 intervention…

  12. Evaluating Rural Progress in Mathematics Achievement: Is "Adequate Yearly Progress" (AYP) Feasible, Valid, Reliable, and Fair? Working Paper.

    ERIC Educational Resources Information Center

    Lee, Jaekyung

    The No Child Left Behind Act requires standards-based accountability for school districts and schools receiving Title I funds. A major component of this policy is to report whether districts and schools are making "adequate yearly progress" (AYP) based on their performance goals. This paper raises questions for rural schools using the…

  13. Health literacy and usability of clinical trial search engines.

    PubMed

    Utami, Dina; Bickmore, Timothy W; Barry, Barbara; Paasche-Orlow, Michael K

    2014-01-01

    Several web-based search engines have been developed to assist individuals to find clinical trials for which they may be interested in volunteering. However, these search engines may be difficult for individuals with low health and computer literacy to navigate. The authors present findings from a usability evaluation of clinical trial search tools with 41 participants across the health and computer literacy spectrum. The study consisted of 3 parts: (a) a usability study of an existing web-based clinical trial search tool; (b) a usability study of a keyword-based clinical trial search tool; and (c) an exploratory study investigating users' information needs when deciding among 2 or more candidate clinical trials. From the first 2 studies, the authors found that users with low health literacy have difficulty forming queries using keywords and have significantly more difficulty using a standard web-based clinical trial search tool compared with users with adequate health literacy. From the third study, the authors identified the search factors most important to individuals searching for clinical trials and how these varied by health literacy level.

  14. A General Framework for the Evaluation of Clinical Trial Quality

    PubMed Central

    Berger, Vance W.; Alperson, Sunny Y.

    2009-01-01

    Flawed evaluation of clinical trial quality allows flawed trials to thrive (get funded, obtain IRB approval, get published, serve as the basis of regulatory approval, and set policy). A reasonable evaluation of clinical trial quality must recognize that any one of a large number of potential biases could by itself completely invalidate the trial results. In addition, clever new ways to distort trial results toward a favored outcome may be devised at any time. Finally, the vested financial and other interests of those conducting the experiments and publishing the reports must cast suspicion on any inadequately reported aspect of clinical trial quality. Putting these ideas together, we see that an adequate evaluation of clinical quality would need to enumerate all known biases, update this list periodically, score the trial with regard to each potential bias on a scale of 0% to 100%, offer partial credit for only that which can be substantiated, and then multiply (not add) the component scores to obtain an overall score between 0% and 100%. We will demonstrate that current evaluations fall well short of these ideals. PMID:19463104

  15. Clinical trial structures

    PubMed Central

    Evans, Scott R.

    2011-01-01

    Most errors in clinical trials are a result of poor planning. Fancy statistical methods cannot rescue design flaws. Thus careful planning with clear foresight is crucial. The selection of a clinical trial design structure requires logic and creativity. Common structural designs are discussed. PMID:21423788

  16. Strategy trials: the answer?

    PubMed

    James, J S

    1999-02-19

    Although a significant amount of promotional information on drugs was presented at the 6th Conference on Retroviruses and Opportunistic Infections, very little of it was related to practical treatment strategy. Doctors and patients have many options but little guidance on selecting which combination of drugs will be most beneficial in long-term use. There is a growing call for "strategy trials" designed to answer those questions. Pharmaceutical companies traditionally have not done strategy trials; their testing is designed to promote their own products. Managing patients in strategy trials is also difficult because they have to fail a treatment before another combination of drugs is used. In addition, collecting valid data from a stragety trial takes longer than collecting data from a starting regimen trial.

  17. Factors associated with adequate weekly reporting for disease surveillance data among health facilities in Nairobi County, Kenya, 2013

    PubMed Central

    Mwatondo, Athman Juma; Ng'ang'a, Zipporah; Maina, Caroline; Makayotto, Lyndah; Mwangi, Moses; Njeru, Ian; Arvelo, Wences

    2016-01-01

    Introduction Kenya adopted the Integrated Disease Surveillance and Response (IDSR) strategy in 1998 to strengthen disease surveillance and epidemic response. However, the goal of weekly surveillance reporting among health facilities has not been achieved. We conducted a cross-sectional study to determine the prevalence of adequate reporting and factors associated with IDSR reporting among health facilities in one Kenyan County. Methods Health facilities (public and private) were enrolled using stratified random sampling from 348 facilities prioritized for routine surveillance reporting. Adequately-reporting facilities were defined as those which submitted >10 weekly reports during a twelve-week period and a poor reporting facilities were those which submitted <10 weekly reports. Multivariate logistic regression with backward selection was used to identify risk factors associated with adequate reporting. Results From September 2 through November 30, 2013, we enrolled 175 health facilities; 130(74%) were private and 45(26%) were public. Of the 175 health facilities, 77 (44%) facilities classified as adequate reporting and 98 (56%) were reporting poorly. Multivariate analysis identified three factors to be independently associated with weekly adequate reporting: having weekly reporting forms at visit (AOR19, 95% CI: 6-65], having posters showing IDSR functions (AOR8, 95% CI: 2-12) and having a designated surveillance focal person (AOR7, 95% CI: 2-20). Conclusion The majority of health facilities in Nairobi County were reporting poorly to IDSR and we recommend that the Ministry of Health provide all health facilities in Nairobi County with weekly reporting tools and offer specific trainings on IDSR which will help designate a focal surveillance person. PMID:27303581

  18. Pilot and Repeat Trials as Development Tools Associated with Demonstration of Bioequivalence.

    PubMed

    Fuglsang, Anders

    2015-05-01

    The purpose of this work is to use simulated trials to study how pilot trials can be implemented in relation to bioequivalence testing, and how the use of the information obtained at the pilot stage can influence the overall chance of showing bioequivalence (power) or the chance of approving a truly bioinequivalent product (type I error). The work also covers the use of repeat pivotal trials since the difference between a pilot trial followed by a pivotal trial and a pivotal trial followed by a repeat trial is mainly a question of whether a conclusion of bioequivalence can be allowed after the first trial. Repeating a pivotal trial after a failed trial involves dual or serial testing of the bioequivalence null hypothesis, and the paper illustrates how this may inflate the type I error up to almost 10%. Hence, it is questioned if such practice is in the interest of patients. Tables for power, type I error, and sample sizes are provided for a total of six different decision trees which allow the developer to use either the observed geometric mean ratio (GMR) from the first or trial or to assume that the GMR is 0.95. In cases when the true GMR can be controlled so as not to deviate more from unity than 0.95, sequential design methods ad modum Potvin may be superior to pilot trials. The tables provide a quantitative basis for choosing between sequential designs and pivotal trials preceded by pilot trials.

  19. 48 CFR 52.216-29 - Time-and-Materials/Labor-Hour Proposal Requirements-Non-Commercial Item Acquisition With Adequate...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...-Hour Proposal Requirements-Non-Commercial Item Acquisition With Adequate Price Competition. 52.216-29... Proposal Requirements—Non-Commercial Item Acquisition With Adequate Price Competition (FEB 2007) (a) The... Time-and-Materials/Labor-Hour Proposal Requirements—Non-Commercial Item Acquisition With Adequate...

  20. Distributed Space Solar Power

    NASA Technical Reports Server (NTRS)

    Fork, Richard L.

    2001-01-01

    The objective was to assess the feasibility of safely collecting solar power at geostationary orbit and delivering it to earth. A strategy which could harness a small fraction of the millions of gigawatts of sunlight passing near earth could adequately supply the power needs of earth and those of space exploration far into the future. Light collected and enhanced both spatially and temporally in space and beamed to earth provides probably the only practical means of safe and efficient delivery of this space solar power to earth. In particular, we analyzed the feasibility of delivering power to sites on earth at a comparable intensity, after conversion to a usable form, to existing power needs. Two major obstacles in the delivery of space solar power to earth are safety and the development of a source suitable for space. We focused our approach on: (1) identifying system requirements and designing a strategy satisfying current eye and skin safety requirements; and (2) identifying a concept for a potential space-based source for producing the enhanced light.

  1. Moral justification of Phase 1 oncology trials.

    PubMed

    Dubov, Alex

    2014-06-01

    This article attempts to answer the following normative questions: Can one consider the design of Phase 1 trials ethically appropriate due to the unfavorable ratio of risks and benefits? What are some ethical safeguards for Phase 1 oncology research? A comparative review of literature contributed to the consolidation of the proposed ethical framework for Phase 1 oncology trials. This framework gives a special attention to issues of therapeutic misconception and vulnerability. The benefits and dangers associated with the enrollment in trials are described as well as the absence of alternatives, treatment-specific optimism, and vagueness in factual presentation during the informed consent process. The notion of therapeutic misconception is contrasted with optimism despite realism that stems from psychological, cultural, and religious factors and not necessarily from the lack of information. Close attention is given to the possible ways in which the inherent uncertainty and resulting cognitive biases may affect the informed consent process and the definition of therapeutic misconception. The article ends with recommendations for an ethical way of enrolling palliative patients in early stages of oncology research, giving special attention to provision of adequate consent, protection of vulnerability, and avoidance of therapeutic misconception.

  2. Strategies to improve retention in randomised trials

    PubMed Central

    Brueton, Valerie C; Tierney, Jayne; Stenning, Sally; Harding, Seeromanie; Meredith, Sarah; Nazareth, Irwin; Rait, Greta

    2013-01-01

    Background Loss to follow-up from randomised trials can introduce bias and reduce study power, affecting the generalisability, validity and reliability of results. Many strategies are used to reduce loss to follow-up and improve retention but few have been formally evaluated. Objectives To quantify the effect of strategies to improve retention on the proportion of participants retained in randomised trials and to investigate if the effect varied by trial strategy and trial setting. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PreMEDLINE, EMBASE, PsycINFO, DARE, CINAHL, Campbell Collaboration's Social, Psychological, Educational and Criminological Trials Register, and ERIC. We handsearched conference proceedings and publication reference lists for eligible retention trials. We also surveyed all UK Clinical Trials Units to identify further studies. Selection criteria We included eligible retention trials of randomised or quasi-randomised evaluations of strategies to increase retention that were embedded in 'host' randomised trials from all disease areas and healthcare settings. We excluded studies aiming to increase treatment compliance. Data collection and analysis We contacted authors to supplement or confirm data that we had extracted. For retention trials, we recorded data on the method of randomisation, type of strategy evaluated, comparator, primary outcome, planned sample size, numbers randomised and numbers retained. We used risk ratios (RR) to evaluate the effectiveness of the addition of strategies to improve retention. We assessed heterogeneity between trials using the Chi2 and I2 statistics. For main trials that hosted retention trials, we extracted data on disease area, intervention, population, healthcare setting, sequence generation and allocation concealment. Main results We identified 38 eligible retention trials. Included trials evaluated six broad types of strategies to improve retention. These

  3. 42 CFR 84.170 - Non-powered air-purifying particulate respirators; description.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... that contain adequate oxygen to support life. (b) Non-powered air-purifying particulate respirators are... includes oil-based liquid particulates. (c) Non-powered air-purifying particulate respirators...

  4. A randomized controlled trial comparing the effects of yoga with an active control on ambulatory blood pressure in individuals with prehypertension and stage 1 hypertension.

    PubMed

    Hagins, Marshall; Rundle, Andrew; Consedine, Nathan S; Khalsa, Sat Bir S

    2014-01-01

    The purpose of this study was to compare the effects of yoga with an active control (nonaerobic exercise) in individuals with prehypertension and stage 1 hypertension. A randomized clinical trial was performed using two arms: (1) yoga and (2) active control. Primary outcomes were 24-hour day and night ambulatory systolic and diastolic blood pressures. Within-group and between-group analyses were performed using paired t tests and repeated-measures analysis of variance (time × group), respectively. Eighty-four participants enrolled, with 68 participants completing the trial. Within-group analyses found 24-hour diastolic, night diastolic, and mean arterial pressure all significantly reduced in the yoga group (-3.93, -4.7, -4.23 mm Hg, respectively) but no significant within-group changes in the active control group. Direct comparisons of the yoga intervention with the control group found a single blood pressure variable (diastolic night) to be significantly different (P=.038). This study has demonstrated that a yoga intervention can lower blood pressure in patients with mild hypertension. Although this study was not adequately powered to show between-group differences, the size of the yoga-induced blood pressure reduction appears to justify performing a definitive trial of this intervention to test whether it can provide meaningful therapeutic value for the management of hypertension.

  5. Does adding noradrenaline reuptake inhibition to selective serotonin reuptake inhibition improve efficacy in patients with depression? A systematic review of meta-analyses and large randomised pragmatic trials.

    PubMed

    Bradley, Andrew J; Lenox-Smith, Alan J

    2013-08-01

    Selective serotonin reuptake inhibitors (SSRIs) are recommended as first-line pharmacological treatment for depression and are the most commonly prescribed class of antidepressants. However, there is substantial evidence that noradrenaline has a role in the pathogenesis and treatment of depression. This review aims to examine the evidence of including noradrenaline reuptake inhibition with serotonin reuptake inhibition with respect to increasing efficacy in the treatment of depression. Evidence from meta-analysis of randomised controlled trials (RCTs) and randomised pragmatic trials was found in support of greater efficacy of the serotonin noradrenaline reuptake inhibitors (SNRIs), venlafaxine and duloxetine, in moderate to severe depression compared to SSRIs but no evidence was found for superiority of milnacipran. There is sufficient current evidence that demonstrates an increase in efficacy, when noradrenaline reuptake is added to serotonin (5-HT) reuptake, to suggest that patients with severe depression or those who have failed to reach remission with a SSRI may benefit from treatment with a SNRI. However, as these conclusions are drawn from the evidence derived from meta-analyses and pragmatic trials, large adequately powered RCTs using optimal dosing regimens and clinically relevant outcome measures in severe depression and SSRI treatment failures are still required to confirm these findings.

  6. A randomized controlled trial comparing the effects of yoga to an active control on ambulatory blood pressure in individuals with Pre- and Stage 1 Hypertension

    PubMed Central

    Hagins, Marshall; Rundle, Andrew; Consedine, Nathan S.; Khalsa, Sat Bir S.

    2013-01-01

    The purpose of this study was to compare the effects of yoga to an active control (non-aerobic exercise) in individuals with pre- and Stage 1 hypertension. A randomized clinical trial was performed using two arms: 1) yoga and 2) active control. Primary outcomes were 24-hour, day and night ambulatory systolic and diastolic blood pressures. Within-group and between-group analyses were performed using paired t-tests and repeated measures ANOVAs (time x group), respectively. Eighty-four participants enrolled with 68 participants completing the trial. Within-group analyses found 24-hour diastolic, night diastolic, and mean arterial pressure all significantly reduced in the yoga group (−3.93, −4.7, −4.23 mmHg, respectively) but no significant within-group changes in the active control group. Direct comparisons of the yoga intervention to the control group found a single blood pressure variable (diastolic night) to be significantly different (p =.038). This study has demonstrated that a yoga intervention can lower blood pressure in patients with mild hypertension. Although this study was not adequately powered to show between-group differences, the size of the yoga-induced blood pressure reduction we observed appears to justify performing a definitive trial of this intervention to test whether it can provide meaningful therapeutic value for the management of hypertension. PMID:24387700

  7. The Leap of a Provincial SME into the Global Market Using E-commerce: The Success of Adequate Planning

    NASA Astrophysics Data System (ADS)

    Sainz de Abajo, Beatriz; García Salcines, Enrique; Burón Fernández, F. Javier; López Coronado, Miguel; de Castro Lozano, Carlos

    The leap into the global market is not easy when it involves a provincial family business. This article demonstrates how adequate planning is fundamental in a small and medium-sized enterprise (SME) with the tight budget they have available to them, in order to be able to differentiate themselves in a highly competitive market, taking into accounts the benefits and risks involved. The Information Technology (IT) tools put in place will give the necessary support and allow for the possibility of increasing and improving the infrastructure as the company requires. An adequate strategy for the future to increases sales would be e-marketing techniques as well as the current promotions which contribute to diffusing the brand.

  8. Cognitive Attributes, Attention, and Self-Efficacy of Adequate and Inadequate Responders in a Fourth Grade Reading Intervention

    PubMed Central

    Cho, Eunsoo; Roberts, Garrett J.; Capin, Philip; Roberts, Greg; Miciak, Jeremy; Vaughn, Sharon

    2015-01-01

    We examined cognitive attributes, attention, and self-efficacy of fourth grade struggling readers who were identified as adequate responders (n = 27), inadequate responders with comprehension only deficits (n = 46), and inadequate responders with comprehension and word reading deficits (n = 52) after receiving a multicomponent reading intervention. We also included typical readers (n = 40). These four groups were compared on measures of nonverbal reasoning, working memory, verbal knowledge, listening comprehension, phonological awareness, and rapid naming as well as on teacher ratings of attention problems and self-reported self-efficacy. The two inadequate responder groups demonstrated difficulties primarily with verbal knowledge and listening comprehension compared to typical readers and adequate responders. Phonological awareness and rapid naming differentiated the two inadequate responder groups. In addition, both inadequate responder groups showed more attention problems and low self-efficacy compared to typical readers. PMID:26997755

  9. Cognitive Attributes, Attention, and Self-Efficacy of Adequate and Inadequate Responders in a Fourth Grade Reading Intervention.

    PubMed

    Cho, Eunsoo; Roberts, Garrett J; Capin, Philip; Roberts, Greg; Miciak, Jeremy; Vaughn, Sharon

    2015-11-01

    We examined cognitive attributes, attention, and self-efficacy of fourth grade struggling readers who were identified as adequate responders (n = 27), inadequate responders with comprehension only deficits (n = 46), and inadequate responders with comprehension and word reading deficits (n = 52) after receiving a multicomponent reading intervention. We also included typical readers (n = 40). These four groups were compared on measures of nonverbal reasoning, working memory, verbal knowledge, listening comprehension, phonological awareness, and rapid naming as well as on teacher ratings of attention problems and self-reported self-efficacy. The two inadequate responder groups demonstrated difficulties primarily with verbal knowledge and listening comprehension compared to typical readers and adequate responders. Phonological awareness and rapid naming differentiated the two inadequate responder groups. In addition, both inadequate responder groups showed more attention problems and low self-efficacy compared to typical readers.

  10. Acute Whiplash Injury Study (AWIS): a protocol for a cluster randomised pilot and feasibility trial of an Active Behavioural Physiotherapy Intervention in an insurance private setting

    PubMed Central

    Wiangkham, Taweewat; Duda, Joan; Haque, M Sayeed; Price, Jonathan; Rushton, Alison

    2016-01-01

    Introduction Whiplash-associated disorder (WAD) causes substantial social and economic burden internationally. Up to 60% of patients with WAD progress to chronicity. Research therefore needs to focus on effective management in the acute stage to prevent the development of chronicity. Approximately 93% of patients are classified as WADII (neck complaint and musculoskeletal sign(s)), and in the UK, most are managed in the private sector. In our recent systematic review, a combination of active and behavioural physiotherapy was identified as potentially effective in the acute stage. An Active Behavioural Physiotherapy Intervention (ABPI) was developed through combining empirical (modified Delphi study) and theoretical (social cognitive theory focusing on self-efficacy) evidence. This pilot and feasibility trial has been designed to inform the design of an adequately powered definitive randomised controlled trial. Methods and analysis Two parallel phases. (1) An external pilot and feasibility cluster randomised double-blind (assessor and participants), parallel two-arm (ABPI vs standard physiotherapy) clinical trial to evaluate procedures and feasibility. Six UK private physiotherapy clinics will be recruited and cluster randomised by a computer-generated randomisation sequence. Sixty participants (30 each arm) will be assessed at recruitment (baseline) and at 3 months postbaseline. The planned primary outcome measure is the neck disability index. (2) An embedded exploratory qualitative study using semistructured indepth interviews (n=3–4 physiotherapists) and a focus group (n=6–8 patients) and entailing the recruitment of purposive samples will explore perceptions of the ABPI. Quantitative data will be analysed descriptively. Qualitative data will be coded and analysed deductively (identify themes) and inductively (identify additional themes). Ethics and dissemination This trial is approved by the University of Birmingham Ethics Committee (ERN_15-0542). Trial

  11. Polyp Prevention Trial

    Cancer.gov

    The primary objective of the Polyp Prevention Trial (PPT) is to determine whether a low fat, high fiber, high vegetable and fruit eating plan will decrease the recurrence of adenomatous polyps of the large bowel.

  12. TrialNet

    MedlinePlus

    ... If you have T1D in your family, your participation can be the difference. A simple blood test ... through a TrialNet screening and explains how their participation can make a difference in type 1 diabetes ...

  13. Hepatitis C: Clinical Trials

    MedlinePlus

    ... Financial Report (AFR) Budget Submission Recovery Act Resources Business Congressional Affairs Jobs Benefits Booklet Data & Statistics National ... Participation in any clinical trial is voluntary and choosing not to participate will not affect your VA ...

  14. Anchor Trial Launch

    Cancer.gov

    NCI has launched a multicenter phase III clinical trial called the ANCHOR Study -- Anal Cancer HSIL (High-grade Squamous Intraepithelial Lesion) Outcomes Research Study -- to determine if treatment of HSIL in HIV-infected individuals can prevent anal canc

  15. What Are Clinical Trials?

    MedlinePlus

    ... treatments or to behave in particular ways. A famous example is the Framingham Heart Study. Since 1948, ... each phase have a different purpose and help scientists answer different questions: A Phase I trial tests ...

  16. Pulsed Power Driven Fusion Energy

    SciTech Connect

    SLUTZ,STEPHEN A.

    1999-11-22

    Pulsed power is a robust and inexpensive technology for obtaining high powers. Considerable progress has been made on developing light ion beams as a means of transporting this power to inertial fusion capsules. However, further progress is hampered by the lack of an adequate ion source. Alternatively, z-pinches can efficiently convert pulsed power into thermal radiation, which can be used to drive an inertial fusion capsule. However, a z-pinch driven fusion explosion will destroy a portion of the transmission line that delivers the electrical power to the z-pinch. They investigate several options for providing standoff for z-pinch driven fusion. Recyclable Transmission Lines (RTLs) appear to be the most promising approach.

  17. Switching power supply

    DOEpatents

    Mihalka, A.M.

    1984-06-05

    The invention is a repratable capacitor charging, switching power supply. A ferrite transformer steps up a dc input. The transformer primary is in a full bridge configuration utilizing power MOSFETs as the bridge switches. The transformer secondary is fed into a high voltage, full wave rectifier whose output is connected directly to the energy storage capacitor. The transformer is designed to provide adequate leakage inductance to limit capacitor current. The MOSFETs are switched to the variable frequency from 20 to 50 kHz to charge a capacitor from 0.6 kV. The peak current in a transformer primary and secondary is controlled by increasing the pulse width as the capacitor charges. A digital ripple counter counts pulses and after a preselected desired number is reached an up-counter is clocked.

  18. Nuclear Power - Post Fukushima

    NASA Astrophysics Data System (ADS)

    Reyes, Jose, Jr.

    2011-10-01

    The extreme events that led to the prolonged power outage at the Fukushima Daiicchi nuclear plant have highlighted the importance of assuring a means for stable long term cooling of the nuclear fuel and containment following a complete station blackout. Legislative bodies, regulatory agencies and industry are drawing lessons from those events and considering what changes, if any, are needed to nuclear power, post Fukushima. The enhanced safety of a new class of reactor designed by NuScale Power is drawing significant attention in light of the Fukushima events. During normal operation, each NuScale containment is fully immersed in a water-filled stainless steel lined concrete pool that resides underground. The pool, housed in a Seismic Category I building, is large enough to provided 30 days of core and containment cooling without adding water. After 30 days, the decay heat generations coupled with thermal radiation heat transfer is completely adequate to remove core decay heat for an unlimited period of time. These passive power systems can perform their function without requiring an external supply of water of power. An assessment of the NuScale passive systems is being performed through a comprehensive test program that includes the NuScale integral system test facility at Oregon State University

  19. Camperdown Program for Adults Who Stutter: A Student Training Clinic Phase I Trial

    ERIC Educational Resources Information Center

    Cocomazzo, Nadia; Block, Susan; Carey, Brenda; O'Brian, Sue; Onslow, Mark; Packman, Ann; Iverach, Lisa

    2012-01-01

    Objectives: During speech pathology professional preparation there is a need for adequate student instruction with speech-restructuring treatments for adults. An important part of that clinical educational experience is to participate in a clinical setting that produces outcomes equivalent to those attained during clinical trials. A previous…

  20. Methodology for conduct of epidemiologic surveys and randomized controlled trials of diabetic polyneuropathy.

    PubMed

    Dyck, Peter James

    2014-01-01

    This chapter outlines: (1) the reasons why epidemiologic surveys and randomized controlled clinical trials (RCTs) of diabetic polyneuropathy (DPN) are difficult and expensive, and often poorly done, (2) primary and secondary neuropathy end points, (3) single versus composite neuropathic end points, (4) adequate reference values from study of population representative cohorts, and (5) the issue of clinical proficiency.

  1. Male partner antenatal attendance and HIV testing in eastern Uganda: a randomized facility-based intervention trial

    PubMed Central

    2011-01-01

    attendance by 10%. Significantly, the majority of male partners who attended the antenatal clinic accepted HIV testing. Therefore, to further evaluate this simple and cost-effective intervention method, adequately powered studies are required to assess its effectiveness in increasing partner participation in antenatal clinics and the programme for prevention of mother to child transmission of HIV. Trial Registration ClinicalTrials.gov Identifier: NCT01144234. PMID:21914207

  2. Is Teacher Pay "Adequate?"

    ERIC Educational Resources Information Center

    Podgursky, Michael

    2006-01-01

    In school finance lawsuits plaintiffs often claim that pay levels are not sufficient to recruit teachers who can deliver constitutionally-mandated levels of educational services. In this paper I consider several ways in which one might bring economic theory and data to bear on that question. I conclude that at present, and at least for the near…

  3. To amend the Federal Power Act to provide additional authorities to adequately protect the critical electric infrastructure against cyber attack, and for other purposes.

    THOMAS, 111th Congress

    Rep. Thompson, Bennie G. [D-MS-2

    2009-04-30

    05/26/2009 Referred to the Subcommittee on Emerging Threats, Cybersecurity, and Science and Technology. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  4. Mitigating the Effects of Nonadherence in Clinical Trials

    PubMed Central

    Bain, Earle E.; McCann, David J.; Skolnick, Phil; Laughren, Thomas; Hanina, Adam; Burch, Daniel

    2016-01-01

    Abstract Accounting for subject nonadherence and eliminating inappropriate subjects in clinical trials are critical elements of a successful study. Nonadherence can increase variance, lower study power, and reduce the magnitude of treatment effects. Inappropriate subjects (including those who do not have the illness under study, fail to report exclusionary conditions, falsely report medication adherence, or participate in concurrent trials) confound safety and efficacy signals. This paper, a product of the International Society for CNS Clinical Trial Methodology (ISCTM) Working Group on Nonadherence in Clinical Trials, explores and models nonadherence in clinical trials and puts forth specific recommendations to identify and mitigate its negative effects. These include statistical analyses of nonadherence data, novel protocol design, and the use of biomarkers, subject registries, and/or medication adherence technologies. PMID:26634893

  5. Adherence and the Lie in a HIV Prevention Clinical Trial

    PubMed Central

    Stadler, Jonathan; Scorgie, Fiona; van der Straten, Ariane; Saethre, Eirik

    2016-01-01

    The lie has been presented as a performance that protects identities against moral judgment in the context of power imbalances. We explore this assertion from the perspective of a pre-exposure prophylaxis trial to prevent HIV for African women in South Africa, in which context biological evidence of widespread lying about product adherence was produced, resulting in a moral discourse that opposed altruistic and selfish motivations. In this article, we seek to understand the meaning of the lie from the perspective of women trial participants. Seeing the trial as representing a hopeful future, and perfect adherence as sustaining their investment in this, participants recited scripted accounts of adherence and performed the role of the perfect adherer, while identifying other participants as dishonest. Given that clinical trials create moral orders and adherence is key to this, we argue that women embraced the apparatus of the clinical trial to assert their moral subjectivities. PMID:26575611

  6. Primer: measuring the effects of treatment in clinical trials.

    PubMed

    Ward, Michael M

    2007-05-01

    The results of clinical trials are often used as the basis for changes in clinical practice. Proper execution and interpretation of the results of trials are, therefore, of paramount importance to the welfare of patients. The results of a clinical trial are based on four key elements: the choice of the primary study end point, the method used to compare end points between groups, the clinically meaningful difference in the primary end point selected a priori by the investigators, and the power of the study to detect as statistically significant a difference between groups that is as large as the preselected clinically meaningful difference. These key elements directly follow from the primary hypothesis tested by the trial. This article reviews the basic features of these four elements, and the influence they have on the interpretation of clinical trials.

  7. [Prevention and handling of missing data in clinical trials].

    PubMed

    Jiang, Zhi-wei; Li, Chan-juan; Wang, Ling; Xia, Jie-lai

    2015-11-01

    Missing data is a common but unavoidable issue in clinical trials. It not only lowers the trial power, but brings the bias to the trial results. Therefore, on one hand, the missing data handling methods are employed in data analysis. On the other hand, it is vital to prevent the missing data in the trials. Prevention of missing data should take the first place. From the perspective of data, firstly, some measures should be taken at the stages of protocol design, data collection and data check to enhance the patients' compliance and reduce the unnecessary missing data. Secondly, the causes of confirmed missing data in the trials should be notified and recorded in detail, which are very important to determine the mechanism of missing data and choose the suitable missing data handling methods, e.g., last observation carried forward (LOCF); multiple imputation (MI); mixed-effect model repeated measure (MMRM), etc.

  8. Ethics and clinical trials.

    PubMed

    Chassany, O; Duracinský, M

    1999-01-01

    The current reference guideline about ethics in clinical trials is the Declaration of Helsinki of human rights in medical research. Three major principles are emphasised: respect of the patient to accept or not to participate in a trial, the constraints and the presumed risks must be acceptable for patients included in a study, and vulnerable subjects should not participate in studies. The investigator is responsible for obtaining a free and well-informed consent from patients before their inclusion in a study. Where possible, a new drug should always first be compared to placebo in order to prove its superiority. Else, a small-sized trial comparing a new drug versus a reference treatment can lead to an erroneous conclusion of absence of difference. Moreover, good results or improvement are obtained in at least 30% of cases with placebo, whatever the disease. The use of placebo is unethical in life-threatening diseases and when an effective proved drug exists. The use of placebo is ethical in severe diseases with no efficient drug, in some severe diseases even when an active reference treatment is available, and in all moderate and functional diseases. In order to detect flawed studies, most journals now ask for any manuscript submitted and reporting results of a randomised clinical trial to join a checklist in order to verify the quality of the trial. Finally, it remains the responsibility of the doctor to decide whether or not a protocol is ethical, to participate or not and to include patients or not.

  9. Acupuncture for Symptomatic Treatment of Fatigue in Parkinson's Disease: Trial Design and Implementation.

    PubMed

    Corbin, Lisa; Childs, Rebecca; Dilli, Caitlin; Christian, Mary K; Wong, Ban; Dong-Cedar, Daisy; Kluger, Benzi M

    2016-08-01

    Background: Acupuncture use is increasing worldwide for many conditions, including movement disorders. Clinical research in acupuncture has also increased to test anecdotal reports of clinical benefits empirically and investigate potential mechanisms. Method: This article describes considerations for designing a double-blinded, randomized, placebo-controlled clinical trial of acupuncture for fatigue in Parkinson's disease (PD) and describes the current authors' experience in the implementation and early conduct of this trial. Relevant literature is also reviewed to provide guidance for other researchers seeking to perform clinical research relevant to PD and related disorders. Results: Trial design should be driven by a well-defined research question and sufficient detail to meet Standards for Reporting Interventions in Clinical Trials of Acupuncture criteria when a trial is complete. Important items for review include: randomization and blinding; recruitment and participant selection; sham methodology choice; staff training; and practical implementation of study procedures. Sample forms used for the current authors' trial are shared. Conclusions: High-quality clinical trials of acupuncture can provide valuable information for clinicians, patients, and policymakers. Acupuncture trials differ in critical ways from pharmaceutical trials and might require additional considerations regarding design and implementation. Adequate preparation for the unique challenges of acupuncture studies can improve trial implementation, design, efficiency, and impact.

  10. Phentolamine as a treatment for poor mixing in transposition of the great arteries with adequate intraatrial communication.

    PubMed

    Galal, M O; El-Naggar, W I; Sharfi, M H

    2005-01-01

    Patients with transposition of the great arteries often show poor mixing for different reasons, even after adequate balloon atrial septostomy. We present a patient with such a lesion whose clinical status improved dramatically after phentolamine was applied. We believe this improvement is due to reduction in afterload caused by the alpha(2) blocker and also possibly as a response to a presumptive effect of the drug on the diastolic function of the right ventricle, allowing more left-to-right shunt across the atrial septal defect. Both phenomena can improve cardiac output in such a situation.

  11. Receptor-level interrelationships of amino acids and the adequate amino acid type hormones in Tetrahymena: a receptor evolution model.

    PubMed

    Csaba, G; Darvas, Z

    1986-01-01

    Histidine stimulates the phagocytosis of Tetrahymena to the same extent as histamine, and also stimulates its division, which histamine does not. Tyrosine and diiodotyrosine equally stimulate the growth of the Tetrahymena. Both amino acids inhibit the characteristic influence of the adequate amino acid hormone when added to Tetrahymena culture 72 h in advance of it. Primary interaction with diiodotyrosine and tyrosine notably increases the cellular growth rate. Histamine has a similar, although less notable effect than histidine. In the light of these experimental observations there is reason to postulate that the receptors of the amino acid hormones have developed from amino acid receptors.

  12. Angiographic outcomes contradict platelet data in the PLATO trial: confusion over official trial substudies.

    PubMed

    Serebruany, Victor L

    2014-01-01

    Major indication-seeking phase 3 clinical trials usually include numerous subanalyses and substudies designed to facilitate the interpretation of results, often providing putative mechanisms that might explain clinical outcomes. Such subanalyses and/or substudies may focus on socioeconomic implications, cost-effectiveness, biomarker applicability, subgroup analyses, etc. Novel antiplatelet agents may benefit from substudies aimed at elucidating the effects on platelets, while angiographic data are also essential for the adequate assessment of coronary flow. Ideally, the data yielded from substudies should correlate well with the main results of the trial. However, in the PLATO (PLATelet Inhibition and Clinical Outcomes) trial, official angiographic data (PLATO-A) contradict platelet (PLATO-P) substudy results. While the large (n = 2,616) PLATO-A concluded that coronary flow and myocardial perfusion were almost identical after ticagrelor or clopidogrel, the small (n = 24) single-center PLATO-P suggested that ticagrelor achieved a highly significantly greater antiplatelet effect compared to clopidogrel after loading in patients enrolled in the same trial and at similar time points. In contrast to PLATO-P, PLATO-A corresponds well with clinical outcomes including the early percutaneous coronary intervention 'ticagrelor death paradox' in PLATO-USA patients and the lack of an early ticagrelor benefit in the overall invasive PLATO cohort reported by the FDA. The discrepancy between PLATO-A and PLATO-P is obvious and lacks a reasonable explanation: platelet activity and coronary flow are generally inversely related, as consistently shown for other antiplatelet regimens, and should be particularly matched when assessed in the frame of the same trial.

  13. A clinical trial primer: historical perspective and modern implementation.

    PubMed

    Karsh, Lawrence I

    2012-01-01

    The structure of modern clinical trials is designed to protect patient safety while generating safety and efficacy data. Safety is the primary concern, and United States regulations are shaped by a series of responses to incidents, including notable safety lapses and unethical trials. These regulations focus on 3 essential components, defined by the 1979 Belmont Report: respect for persons, beneficence, and justice. Further, the international community has formally outlined good clinical practice (GCP), which mandates that trials are designed to produce meaningful data, conform to international ethics regulations, and provide assurances that data are reported in a credible and reliable manner. The Food and Drug Administration (FDA) and federal government have outlined the necessary components of clinical trials in the Code of Federal Regulations (CFR). These include institutional review boards (IRBs), standard operating procedures (SOPs), sites, sponsors, investigators, and patients. The investigator is the center of the trial and is required to sign an agreement with the federal government to uphold the CFR. Investigator duties include making sure that investigator and support staff having appropriate qualifications, delegating duties, monitoring the study for compliance and record keeping, providing care, and accepting accountability for the trial, among other duties. Physicians, who already have significant time demands, need a well-trained staff, including clinical coordinators, to adequately meet these duties. Despite these requirements, trials can have significant benefits for investigators, practices, and patients, foremost of which is the ability to provide cutting edge care. However, the clinical trial process requires routine evaluation and continual performance improvement in order to ensure that patients not only receive excellent care, but also do so in the safest possible manner.

  14. A brief history of placebos and clinical trials in psychiatry.

    PubMed

    Shorter, Edward

    2011-04-01

    The history of placebos in psychiatry can be understood only in the context of randomized controlled trials (RCTs). Placebo treatments are as old as medicine itself, and are particularly effective in dealing with psychosomatic symptoms. In psychiatry, placebos have mainly been featured in clinical drug trials. The earliest controlled trial in psychiatry (not involving drugs) occurred in 1922, followed by the first crossover studies during the 1930s. Meanwhile the concept of randomization was developed during the interwar years by British statistician Ronald A Fisher, and introduced in 3 trials of tuberculosis drugs between 1947 and 1951. These classic studies established the RCT as the gold standard in pharmaceutical trials, and its status was cemented during the mid-1950s. Nevertheless, while the placebo became established as a standard measure of drug action, placebo treatments became stigmatized as unethical. This is unfortunate, as they constitute one of the most powerful therapies in psychiatry. In recent years, moreover, the dogma of the placebo-controlled trial as the only acceptable data for drug licensing is also being increasingly discredited. This backlash has had 2 sources: one is the recognition that the US Food and Drug Administration has been too lax in permitting trials controlled with placebos alone, rather than also using an active agent as a test of comparative efficacy. In addition, there is evidence that in the hands of the pharmaceutical industry, the scientific integrity of RCTs themselves has been degraded into a marketing device. The once-powerful placebo is thus threatened with extinction.

  15. Five-Kilometers Time Trial: Preliminary Validation of a Short Test for Cycling Performance Evaluation

    PubMed Central

    Dantas, Jose Luiz; Pereira, Gleber; Nakamura, Fabio Yuzo

    2015-01-01

    Background: The five-kilometer time trial (TT5km) has been used to assess aerobic endurance performance without further investigation of its validity. Objectives: This study aimed to perform a preliminary validation of the TT5km to rank well-trained cyclists based on aerobic endurance fitness and assess changes of the aerobic endurance performance. Materials and Methods: After the incremental test, 20 cyclists (age = 31.3 ± 7.9 years; body mass index = 22.7 ± 1.5 kg/m2; maximal aerobic power = 360.5 ± 49.5 W) performed the TT5km twice, collecting performance (time to complete, absolute and relative power output, average speed) and physiological responses (heart rate and electromyography activity). The validation criteria were pacing strategy, absolute and relative reliability, validity, and sensitivity. Sensitivity index was obtained from the ratio between the smallest worthwhile change and typical error. Results: The TT5km showed high absolute (coefficient of variation < 3%) and relative (intraclass coefficient correlation > 0.95) reliability of performance variables, whereas it presented low reliability of physiological responses. The TT5km performance variables were highly correlated with the aerobic endurance indices obtained from incremental test (r > 0.70). These variables showed adequate sensitivity index (> 1). Conclusions: TT5km is a valid test to rank the aerobic endurance fitness of well-trained cyclists and to differentiate changes on aerobic endurance performance. Coaches can detect performance changes through either absolute (± 17.7 W) or relative power output (± 0.3 W.kg-1), the time to complete the test (± 13.4 s) and the average speed (± 1.0 km.h-1). Furthermore, TT5km performance can also be used to rank the athletes according to their aerobic endurance fitness. PMID:26448846

  16. Adverse event reporting in nonpharmacologic, noninterventional pain clinical trials: ACTTION systematic review.

    PubMed

    Hunsinger, Matthew; Smith, Shannon M; Rothstein, Daniel; McKeown, Andrew; Parkhurst, Melissa; Hertz, Sharon; Katz, Nathaniel P; Lin, Allison H; McDermott, Michael P; Rappaport, Bob A; Turk, Dennis C; Dworkin, Robert H

    2014-11-01

    Assessment of treatment safety is 1 of the primary goals of clinical trials. Organizations and working groups have created reporting guidelines for adverse events (AEs). Previous research examining AE reporting for pharmacologic clinical trials of analgesics in major pain journals found many reporting inadequacies, suggesting that analgesic trials are not adhering to existing AE reporting guidelines. The present systematic review documented AE reporting in 3 main pain journals for nonpharmacologic, noninterventional (NP/NI) trials examining pain treatments. To broaden our pool of nonpharmacologic trials, we also included trials examining acupuncture, leech therapy, and noninvasive stimulation techniques (eg, transcutaneous electrical nerve stimulation). We documented AE reporting at 2 levels of specificity using coding manuals based on the Consolidated Standards of Reporting Trials (CONSORT) harms reporting standards and Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) AE reporting checklist. We identified a number of inadequacies in AE reporting across the 3 journals. For example, using the ACTTION coding manual, we found that less than one-half of the trials reported specific AE assessment methods; approximately one-third of the trials reported withdrawals due to AEs for each study arm; and about one-fourth of the trials reported all specific AEs. We also examined differences in AE reporting across several trial characteristics, finding that AE reporting was generally more detailed in trials with patients versus those using healthy volunteers undergoing experimentally evoked pain. These results suggest that investigators conducting and reporting NP/NI clinical trials are not adequately describing the assessment and occurrence of AEs.

  17. Volunteering for clinical trials.

    PubMed

    Mirken, B

    1999-04-01

    HIV/AIDS researchers are finding it increasingly difficult to recruit volunteers for their studies, and are working on designing studies that are more broadly applicable and palatable to the volunteers. Studies offer both opportunities and risks for people who volunteer. This overview describes the basics of trial design and practice, with the purposes of each trial phase clearly described. Participation requires informed consent, and before entering a study patients should ask, among other things, what side effects they can expect, and who will manage their treatment.

  18. Power output measurement during treadmill cycling.

    PubMed

    Coleman, D A; Wiles, J D; Davison, R C R; Smith, M F; Swaine, I L

    2007-06-01

    The study aim was to consider the use of a motorised treadmill as a cycling ergometry system by assessing predicted and recorded power output values during treadmill cycling. Fourteen male cyclists completed repeated cycling trials on a motorised treadmill whilst riding their own bicycle fitted with a mobile ergometer. The speed, gradient and loading via an external pulley system were recorded during 20-s constant speed trials and used to estimate power output with an assumption about the contribution of rolling resistance. These values were then compared with mobile ergometer measurements. To assess the reliability of measured power output values, four repeated trials were conducted on each cyclist. During level cycling, the recorded power output was 257.2 +/- 99.3 W compared to the predicted power output of 258.2 +/- 99.9 W (p > 0.05). For graded cycling, there was no significant difference between measured and predicted power output, 268.8 +/- 109.8 W vs. 270.1 +/- 111.7 W, p > 0.05, SEE 1.2 %. The coefficient of variation for mobile ergometer power output measurements during repeated trials ranged from 1.5 % (95 % CI 1.2 - 2.0 %) to 1.8 % (95 % CI 1.5 - 2.4 %). These results indicate that treadmill cycling can be used as an ergometry system to assess power output in cyclists with acceptable accuracy.

  19. Median Urinary Iodine Concentrations Are Indicative of Adequate Iodine Status among Women of Reproductive Age in Prey Veng, Cambodia.

    PubMed

    Karakochuk, Crystal D; Michaux, Kristina D; Chai, Tze L; Chan, Benny B; Whitfield, Kyly C; Barr, Susan I; McLean, Judy; Talukder, Aminuzzaman; Hou, Kroeun; Ly, Sokhoing; Green, Tim J

    2016-03-03

    Iodine deficiency disorders are estimated to affect over 1.9 million people worldwide. Iodine deficiency is especially serious for women during pregnancy and lactation because of the negative consequences for both mother and infant. The aim of this cross-sectional study was to determine the median urinary iodine concentration (UIC) as a population-level indicator of iodine status among rural women farmers of reproductive age (18-45 years) in the province of Prey Veng, Cambodia. A total of 450 women provided a spot morning urine sample in 2012. Of those women, 93% (n = 420) were non-pregnant and 7% (n = 30) were pregnant at the time of collection. UIC was quantified using the Sandell-Kolthoff reaction with modifications. The median UIC of non-pregnant (139 μg/L) and pregnant women (157 μg/L) were indicative of adequate iodine status using the WHO/UNICEF/ICCIDD epidemiological criteria for both groups (median UIC between 100-199 and 150-249 μg/L, respectively). We conclude that non-pregnant and pregnant women in rural Prey Veng, Cambodia had adequate iodine status based on single spot morning urine samples collected in 2012. More research is warranted to investigate iodine status among larger and more representative populations of women in Cambodia, especially in light of recent policy changes to the national program for universal salt iodization.

  20. Diet quality of Italian yogurt consumers: an application of the probability of adequate nutrient intake score (PANDiet).

    PubMed

    Mistura, Lorenza; D'Addezio, Laura; Sette, Stefania; Piccinelli, Raffaela; Turrini, Aida

    2016-01-01

    The diet quality in yogurt consumers and non-consumers was evaluated by applying the probability of adequate nutrient intake (PANDiet) index to a sample of adults and elderly from the Italian food consumption survey INRAN SCAI 2005-06. Overall, yogurt consumers had a significantly higher mean intake of energy, calcium and percentage of energy from total sugars whereas the mean percentage of energy from total fat, saturated fatty acid and total carbohydrate were significantly (p < 0.01) lower than in non-consumers. The PANDiet index was significantly higher in yogurt consumers than in non-consumers, (60.58 ± 0.33 vs. 58.58 ± 0.19, p < 0.001). The adequacy sub-score for 17 nutrients for which usual intake should be above the reference value was significantly higher among yogurt consumers. The items of calcium, potassium and riboflavin showed the major percentage variation between consumers and non-consumers. Yogurt consumers were more likely to have adequate intakes of vitamins and minerals, and a higher quality score of the diet.

  1. Exercise prescription for the older population: The interactions between physical activity, sedentary time, and adequate nutrition in maintaining musculoskeletal health.

    PubMed

    Shad, Brandon J; Wallis, Gareth; van Loon, Luc J C; Thompson, Janice L

    2016-11-01

    Regular physical activity (PA) promotes musculoskeletal health in older adults. However, the majority of older individuals do not meet current PA guidelines and are also highly sedentary. Emerging evidence indicates that large amounts of sedentary time accelerate the loss of skeletal muscle mass (i.e., sarcopenia) and physical function with advancing age. However, current PA recommendations for sedentary time are non-specific (i.e., keep sedentary time to a minimum). Research indicates that physical inactivity and large amounts of sedentary time accelerate sarcopenic muscle loss by inducing skeletal muscle 'anabolic resistance'. These findings suggest a critical interaction between engaging in 'sufficient' levels of PA, minimising sedentary time, and consuming 'adequate' nutrition to promote optimal musculoskeletal health in older adults. However, current PA recommendations do not take into account the important role that nutrition plays in ensuring older adults can maximise the benefits from the PA in which they engage. The aim of this narrative review is: (1) to briefly summarise the evidence used to inform current public health recommendations for PA and sedentary time in older adults; and (2) to discuss the presence of 'anabolic resistance' in older adults, highlighting the importance of regular PA and minimising sedentary behaviour. It is imperative that the synergy between PA, minimising sedentary behaviour and adequate nutrition is integrated into future PA guidelines to promote optimal musculoskeletal health and metabolic responses in the growing ageing population.

  2. Median Urinary Iodine Concentrations Are Indicative of Adequate Iodine Status among Women of Reproductive Age in Prey Veng, Cambodia

    PubMed Central

    Karakochuk, Crystal D.; Michaux, Kristina D.; Chai, Tze L.; Chan, Benny B.; Whitfield, Kyly C.; Barr, Susan I.; McLean, Judy; Talukder, Aminuzzaman; Hou, Kroeun; Ly, Sokhoing; Green, Tim J.

    2016-01-01

    Iodine deficiency disorders are estimated to affect over 1.9 million people worldwide. Iodine deficiency is especially serious for women during pregnancy and lactation because of the negative consequences for both mother and infant. The aim of this cross-sectional study was to determine the median urinary iodine concentration (UIC) as a population-level indicator of iodine status among rural women farmers of reproductive age (18–45 years) in the province of Prey Veng, Cambodia. A total of 450 women provided a spot morning urine sample in 2012. Of those women, 93% (n = 420) were non-pregnant and 7% (n = 30) were pregnant at the time of collection. UIC was quantified using the Sandell-Kolthoff reaction with modifications. The median UIC of non-pregnant (139 μg/L) and pregnant women (157 μg/L) were indicative of adequate iodine status using the WHO/UNICEF/ICCIDD epidemiological criteria for both groups (median UIC between 100–199 and 150–249 μg/L, respectively). We conclude that non-pregnant and pregnant women in rural Prey Veng, Cambodia had adequate iodine status based on single spot morning urine samples collected in 2012. More research is warranted to investigate iodine status among larger and more representative populations of women in Cambodia, especially in light of recent policy changes to the national program for universal salt iodization. PMID:26950151

  3. Barriers to help-seeking, detection, and adequate treatment for anxiety and mood disorders: implications for health care policy.

    PubMed

    Mechanic, David

    2007-01-01

    Recently, the focus of health policies and initiatives has been directed toward mental health. More precisely, depressive and anxiety disorders have received particular attention because of their disabling outcomes and prevalence among most populations. Despite this increased interest, numerous issues regarding patients' willingness to seek treatment and the adequate recognition and treatment of these disorders by clinicians remain to be addressed. This article considers the factors that influence patients and physicians in their reticence to acknowledge and adequately treat depression and anxiety disorders. It also reviews the impact of society and the media, together with other factors relating to health care organization and administration that affect the treatment of depression and anxiety. In view of the multifaceted challenge involved, efforts to achieve a consensus in determining treatment for those with depressive and anxiety disorders are essential. A consensus will require easy, measurable, and reliable disability indicators; evidence that treatment of patients with varying levels of need is cost effective; and that persons who most need and would benefit from care can be reliably identified among the highly prevalent population of persons with more transient symptoms. Governments and other policymakers should be encouraged to provide appropriate coverage for access to primary and secondary care, the treatments required, and sufficient resources so that care is available when necessary. An important aspect of the challenge is to incorporate these efforts within the realistic constraints of primary care.

  4. [The global and national context regarding the challenges involved in ensuring adequate access to water for human consumption].

    PubMed

    Augusto, Lia Giraldo da Silva; Gurgel, Idê Gomes Dantas; Câmara Neto, Henrique Fernandes; de Melo, Carlos Henrique; Costa, André Monteiro

    2012-06-01

    The scope of this article is to analyze the challenges involved in ensuring access to water for human consumption taking the international and national context into consideration. Based on the UN declaration that access to safe and clean drinking water is a fundamental human right, vulnerabilities are identified that can consist in restrictions to access to adequate supplies. The distribution of water and the population across the planet, pollution, inadequate policies and management lead to environmental injustice. The iniquity of access to water constitutes the contemporary water crisis. From the 1980s onwards, the transnational water market emerged for private control that occurs at three main levels: surface and underground water sources; bottled water; and public water supply services. The conflicts of the multiple uses of water resources, the market and environmental problems have contributed to rendering the health of the population and ecosystems vulnerable. Adequate public policies are essential to ensure the basic human right to access to safe and clean drinking water.

  5. Vigorous cleaning and adequate ventilation are necessary to control an outbreak in a neonatal intensive care unit.

    PubMed

    Shimono, Nobuyuki; Hayashi, Jun; Matsumoto, Hiroko; Miyake, Noriko; Uchida, Yujiro; Shimoda, Shinji; Furusyo, Norihiro; Akashi, Koichi

    2012-06-01

    An outbreak of Bacillus cereus (B. cereus) bacteremia occurred in our neonatal intensive care unit (NICU) in July 2005. Many strains of B. cereus were cultured from patient specimens, as well as from environmental samples such as the surfaces of instruments and air in the NICU. Some of these strains were analyzed by pulsed field gel electrophoresis, and several were confirmed to be identical. We speculated that the bacterial load in the environment had initially increased and then possibly spread throughout the NICU facility via the airflow of the ventilation system. For this reason, besides maintaining standard precautions, we performed a vigorous clean of the NICU, and covered the vents to prevent dust falling from them. These protective measures ended the outbreak. In the hospital environment, adequate ventilation is important, especially in single-occupancy isolation rooms and operating theaters. However, the criteria for the adequate ventilation of multioccupancy rooms for acute care environments such as the NICU have not yet been defined. We need to pay more attention to these environmental factors in order to avoid cross contamination and infectious outbreaks.

  6. Using HMBC and ADEQUATE NMR data to define and differentiate long-range coupling pathways: is the Crews rule obsolete?

    PubMed

    Senior, Mary M; Williamson, R Thomas; Martin, Gary E

    2013-11-22

    It is well known that as molecules become progressively more proton-deficient, structure elucidation becomes correspondingly more challenging. When the ratio of (1)H to (13)C and the sum of other heavy atoms falls below 2, an axiom that has been dubbed the "Crews rule" comes into play. The general premise of the Crews rule is that highly proton-deficient molecules may have structures that are difficult, and in some cases impossible, to elucidate using conventional suites of NMR experiments that include proton and carbon reference spectra, COSY, multiplicity-edited HSQC, and HMBC (both (1)H-(13)C and (1)H-(15)N). However, with access to modern cryogenic probes and microcyroprobes, experiments that have been less commonly utilized in the past and new experiments such as inverted (1)J(CC) 1,n-ADEQUATE are feasible with modest sized samples. In this light, it may well be time to consider revising the Crews rule. The complex, highly proton-deficient alkaloid staurosporine (1) is used as a model proton-deficient compound for this investigation to highlight the combination of inverted (1)J(CC) 1,n-ADEQUATE with 1.7 mm cryoprobe technology.

  7. Acquisition of texture-cued fasting-anticipatory meal-size change in rats with adequate energy intake.

    PubMed

    White, J A; Mok, E; Thibault, L; Booth, D A

    2001-10-01

    To determine if an increase in intake at a meal before a long fast can be conditioned to food texture cues, male Sprague-Dawley rats were given a high- or low-fat diet in one texture (powder or pellet) for 1 h prior to a 12.5-h fast and in the other texture before a 3-h fast. Each group (N = 9) went through a pseudorandom sequence of four duplicates of each texture-fast pairing over 4 experimental days in each of three training trials, followed by one 4-day trial under extinction, i.e. without the difference in fast lengths between textures. Neither the high-fat group nor the low-fat group as a whole gave a clear indication of a learnt texture-cued increase in meal size before the longer fast relative to the shorter fast. However, the rats trained on the high-fat diet that had the highest intakes on the first 4 days of training showed a relative increase in the amount eaten of the texture predicting the longer fast during the third training trial, and this effect also approached statistical significance in the extinction test. These results provide some support for the conclusion that anticipatory hunger/satiety can be differentially conditioned to dietary texture cues, but only if sufficient food is eaten before a short fast to prevent the rise in hunger during longer fasts that reinforces the discriminative increase in meal size.

  8. Effects of Trial Design on Participation and Costs in Clinical Trials, with an Examination of Cost Analysis Methods and Data Sources

    DTIC Science & Technology

    2004-01-01

    Cancer Treatment Study (CCTS). An exploration of the sample size requirements for power and significance levels in clinical trials suggests that proportional representation of subpopulations in trials will often not allow valid inferences to be drawn about differential treatment effects. Where differential treatment effects in subpopulations are suspected, targeted trials should be undertaken. Under-representation of older cancer patients could be accounted for by exclusion criteria based on co-morbid conditions that disproportionately afflict the elderly. The author

  9. Methodological Reporting Quality of Randomized Controlled Trials in 3 Leading Diabetes Journals From 2011 to 2013 Following CONSORT Statement: A System Review.

    PubMed

    Zhai, Xiao; Wang, Yiran; Mu, Qingchun; Chen, Xiao; Huang, Qin; Wang, Qijin; Li, Ming

    2015-07-01

    To appraise the current reporting methodological quality of randomized clinical trials (RCTs) in 3 leading diabetes journals.We systematically searched the literature for RCTs in Diabetes Care, Diabetes and Diabetologia from 2011 to 2013.Characteristics were extracted based on Consolidated Standards of Reporting Trials (CONSORT) statement. Generation of allocation, concealment of allocation, intention-to-treat (ITT) analysis and handling of dropouts were defined as primary outcome and "low risk of bias." Sample size calculation, type of intervention, country, number of patients, funding source were also revealed and descriptively reported. Trials were compared among journals, study years, and other characters.A total of 305 RCTs were enrolled in this study. One hundred eight (35.4%) trials reported adequate generation of allocation, 87 (28.5%) trials reported adequate concealment of allocation, 53 (23.8%) trials used ITT analysis, and 130 (58.3%) trials were adequate in handling of dropouts. Only 15 (4.9%) were "low risk of bias" trials. Studies at a large scale (n > 100) or from European presented with more "low risk of bias" trials than those at a small scale (n ≤ 100) or from other regions. No improvements were found in these 3 years.This study shows that methodological reporting quality of RCTs in the major diabetes journals remains suboptimal. It can be further improved to meet and keep up with the standards of the CONSORT statement.

  10. Clinical Trials: Spline Modeling is Wonderful for Nonlinear Effects.

    PubMed

    Cleophas, Ton J

    2016-01-01

    Traditionally, nonlinear relationships like the smooth shapes of airplanes, boats, and motor cars were constructed from scale models using stretched thin wooden strips, otherwise called splines. In the past decades, mechanical spline methods have been replaced with their mathematical counterparts. The objective of the study was to study whether spline modeling can adequately assess the relationships between exposure and outcome variables in a clinical trial and also to study whether it can detect patterns in a trial that are relevant but go unobserved with simpler regression models. A clinical trial assessing the effect of quantity of care on quality of care was used as an example. Spline curves consistent of 4 or 5 cubic functions were applied. SPSS statistical software was used for analysis. The spline curves of our data outperformed the traditional curves because (1) unlike the traditional curves, they did not miss the top quality of care given in either subgroup, (2) unlike the traditional curves, they, rightly, did not produce sinusoidal patterns, and (3) unlike the traditional curves, they provided a virtually 100% match of the original values. We conclude that (1) spline modeling can adequately assess the relationships between exposure and outcome variables in a clinical trial; (2) spline modeling can detect patterns in a trial that are relevant but may go unobserved with simpler regression models; (3) in clinical research, spline modeling has great potential given the presence of many nonlinear effects in this field of research and given its sophisticated mathematical refinement to fit any nonlinear effect in the mostly accurate way; and (4) spline modeling should enable to improve making predictions from clinical research for the benefit of health decisions and health care. We hope that this brief introduction to spline modeling will stimulate clinical investigators to start using this wonderful method.

  11. Results and lessons from clinical trials using dietary supplements for cancer: direct and indirect investigations.

    PubMed

    Moyad, M A

    2001-11-01

    Randomized controlled trials are generally regarded as the standard of study designs to determine potential causality. The inclusion of a placebo group in these trials, when appropriate, is generally needed to access the efficacy of a drug or dietary supplement. The recent increasing use of dietary supplements and herbal medications by patients makes it imperative to reevaluate the past findings of clinical studies. Several large-scale trials of dietary supplements have been tested in various populations to determine their effect on cancer prevention. Other trials have focused on patients already diagnosed with cancer. In the latter case, it is difficult to involve a placebo because of the serious nature of the disease. Nevertheless, much has been gleaned from these trials directly and indirectly. Overall, when analyzing primary endpoints in these trials, the results have been discouraging and even support the nonuse of certain supplements because of potential adverse effects. Other secondary endpoints in these same trials have revealed some potential encouraging and discouraging data. Individuals who currently qualify for the potential use of dietary supplements for cancer may be restricted to those who have a deficiency in a certain compound despite adequate dietary sources or lifestyle changes. Those individuals with a smoking history or other unhealthy lifestyle seem to have the most to gain or lose from taking certain dietary supplements for cancer. The time seems more than ripe to evaluate past adequate trials with supplements, such as beta-carotene, N-acetyl-cysteine, selenium, shark cartilage, vitamin C, vitamin E, and others. Again, these studies have been disappointing, but they provide insight for the clinician and patient of what to potentially expect when using these supplements for cancer. In addition, indirect trials for other conditions (cardiovascular) may provide future insight into possible results for future cancer prevention trials.

  12. A Randomized Controlled Exercise Training Trial on Insulin Sensitivity in African American Men: The ARTIIS study

    PubMed Central

    Newton, Robert L.; Johnson, William D.; Hendrick, Chelsea; Harris, Melissa; Andrews, Emanuel; Johannsen, Neil; Rodarte, Ruben Q.; Hsia, Daniel S.; Church, Timothy S.

    2015-01-01

    Background Lack of regular physical activity at prescribed intensity levels is a modifiable risk factor for insulin resistance and the development of diabetes. African American men are at increased risk for developing diabetes and most African American men are not meeting the current recommended levels of physical activity. The primary objective of the Aerobic Plus Resistance Training and Insulin Resistance in African American Men (ARTIIS) study is to determine the effectiveness of an exercise training intervention aimed at reducing diabetes risk factors in African American men at risk for developing diabetes. Methods Insufficiently active 35–70 year old African American men with a family history of diabetes were eligible for the study. The 5-month randomized controlled trial assigns 116 men to an exercise training or healthy living control arm. The exercise training arm combines aerobic and resistance training according to the current national physical activity recommendations and is conducted in community (YMCA) facilities. The healthy living arm receives information promoting healthy lifestyle changes. Outcomes Insulin response to an oral glucose load is the primary outcome measure, and changes in physiological parameters, cardiorespiratory fitness, strength, body composition, and psychological well-being comprise the secondary outcomes. Conclusions The ARTIIS study is one of the first adequately powered, rigorously designed studies to investigate the effects of an aerobic plus resistance exercise training program and to assess adherence to exercise training in community facilities, in African American men. PMID:25979318

  13. Exercise Training in Treatment and Rehabilitation of Hip Osteoarthritis: A 12-Week Pilot Trial

    PubMed Central

    Patil, Radhika; Karinkanta, Saija; Tokola, Kari; Kannus, Pekka

    2017-01-01

    Introduction. Osteoarthritis (OA) of the hip is one of the major causes of pain and disability in the older population. Although exercise is an effective treatment for knee OA, there is lack of evidence regarding hip OA. The aim of this trial was to test the safety and feasibility of a specifically designed exercise program in relieving hip pain and improving function in hip OA participants and to evaluate various methods to measure changes in their physical functioning. Materials and Methods. 13 women aged ≥ 65 years with hip OA were recruited in this 12-week pilot study. Results. Pain declined significantly over 30% from baseline, and joint function and health-related quality of life improved slightly. Objective assessment of physical functioning showed statistically significant improvement in the maximal isometric leg extensor strength by 20% and in the hip extension range of motion by 30%. Conclusions. The exercise program was found to be safe and feasible. The present evidence indicates that the exercise program is effective in the short term. However, adequate powered RCTs are needed to determine effects of long-term exercise therapy on pain and progression of hip OA. PMID:28116214

  14. Exploring integrative medicine for back and neck pain - a pragmatic randomised clinical pilot trial

    PubMed Central

    Sundberg, Tobias; Petzold, Max; Wändell, Per; Rydén, Anna; Falkenberg, Torkel

    2009-01-01

    relevant difference between groups that was also supported by a small distribution based effect size, i.e. vitality (-7.3 points, Cohen's d -0.34) which was in favour of IM. There was a clinical trend between groups showing that IM contributed to less use of prescription and non-prescription analgesics (-11.7 and - 9.7 percent units respectively) compared to conventional care. Exploring clinically relevant differences and the SF-36 as the basis for a main outcome measure showed that the sample sizes needed per arm to adequately power a full-scale trial depended on the target domain, i.e. ranging from 60 (vitality) to 339 (role emotion). Conclusion This pilot study investigated the implementation of IM in the primary care management of non-specific back and neck pain. Recruiting patients and implementing IM in routine clinical practice was feasible. The results warrant further exploration into different perspectives and relevant combinations of outcome measures including the use of health resources, drugs and cost-effectiveness to help understand the relevance of IM in primary care. Future research should prioritise larger scale studies considering variability, pain duration and small to moderate treatment effects. Trial registration Clinical trials NCT00565942 PMID:19735542

  15. AcuTrials®: an online database of randomized controlled trials and systematic reviews of acupuncture

    PubMed Central

    2013-01-01

    Background The growing quantity of Complementary and Alternative Medicine literature requires databases enabled with increasingly powerful search capabilities. To address this need in the area of acupuncture research, a bibliographic database of randomized controlled trials (RCTs) and systematic reviews called AcuTrials® has been developed by the Oregon College of Oriental Medicine. AcuTrials® introduces a comprehensive keyword thesaurus that categorizes details of treatment protocols and research design to an extent not currently available in MEDLINE or other databases. Description AcuTrials®, which went live in January of 2010 and is updated monthly, currently contains over 1250 articles from more than 300 journals. Articles included are English language RCTs and systematic reviews that report on medical conditions in human subjects treated by needle acupuncture. Study details are indexed by 14 key domains, such as acupuncture style and needling protocol, to create an acupuncture-relevant, searchable keyword catalogue. Keywords follow the National Library of Medicine (NLM) MeSH terminology when possible, and new keywords were created in cases where no appropriate MeSH terms were available. The resulting keyword catalogue enables users to perform sensitive, targeted searches for particular aspects of acupuncture treatment and research design. Conclusions AcuTrials® provides an extensive and innovative keyword catalogue of acupuncture research, allowing users to efficiently navigate, locate and assess the evidence base in ways not currently possible with other databases. By providing a more powerful suite of search options, the AcuTrials® database has the potential to enhance the accessibility and quality of acupuncture research. PMID:23866767

  16. Clinical Trials: CSDRG Overview

    ERIC Educational Resources Information Center

    Logemann, Jeri A.

    2004-01-01

    Recent importance placed upon efficacy research has spawned the development of the Communication Sciences and Disorders Clinical Trials Research Group (CSDRG). This group, funded by the National Institutes of Health (NIH), was organized by the American Speech Language and Hearing Association to address the need for more treatment efficacy research…

  17. Adaptive enrichment designs for clinical trials.

    PubMed

    Simon, Noah; Simon, Richard

    2013-09-01

    Modern medicine has graduated from broad spectrum treatments to targeted therapeutics. New drugs recognize the recently discovered heterogeneity of many diseases previously considered to be fairly homogeneous. These treatments attack specific genetic pathways which are only dysregulated in some smaller subset of patients with the disease. Often this subset is only rudimentarily understood until well into large-scale clinical trials. As such, standard practice has been to enroll a broad range of patients and run post hoc subset analysis to determine those who may particularly benefit. This unnecessarily exposes many patients to hazardous side effects, and may vastly decrease the efficiency of the trial (especially if only a small subset of patients benefit). In this manuscript, we propose a class of adaptive enrichment designs that allow the eligibility criteria of a trial to be adaptively updated during the trial, restricting entry to patients likely to benefit from the new treatment. We show that our designs both preserve the type 1 error, and in a variety of cases provide a substantial increase in power.

  18. Active video games as a tool to prevent excessive weight gain in adolescents: rationale, design and methods of a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Excessive body weight, low physical activity and excessive sedentary time in youth are major public health concerns. A new generation of video games, the ones that require physical activity to play the games –i.e. active games- may be a promising alternative to traditional non-active games to promote physical activity and reduce sedentary behaviors in youth. The aim of this manuscript is to describe the design of a study evaluating the effects of a family oriented active game intervention, incorporating several motivational elements, on anthropometrics and health behaviors in adolescents. Methods/Design The study is a randomized controlled trial (RCT), with non-active gaming adolescents aged 12 – 16 years old randomly allocated to a ten month intervention (receiving active games, as well as an encouragement to play) or a waiting-list control group (receiving active games after the intervention period). Primary outcomes are adolescents’ measured BMI-SDS (SDS = adjusted for mean standard deviation score), waist circumference-SDS, hip circumference and sum of skinfolds. Secondary outcomes are adolescents’ self-reported time spent playing active and non-active games, other sedentary activities and consumption of sugar-sweetened beverages. In addition, a process evaluation is conducted, assessing the sustainability of the active games, enjoyment, perceived competence, perceived barriers for active game play, game context, injuries from active game play, activity replacement and intention to continue playing the active games. Discussion This is the first adequately powered RCT including normal weight adolescents, evaluating a reasonably long period of provision of and exposure to active games. Next, strong elements are the incorporating motivational elements for active game play and a comprehensive process evaluation. This trial will provide evidence regarding the potential contribution of active games in prevention of excessive weight gain in

  19. Adequate health literacy is associated with higher heart failure knowledge and self-care confidence in hospitalized patients.

    PubMed

    Dennison, Cheryl R; McEntee, Mindy L; Samuel, Laura; Johnson, Brandon J; Rotman, Stacey; Kielty, Alexandra; Russell, Stuart D

    2011-01-01

    Heart failure (HF) patients with inadequate health literacy are at increased risk for poor self-care and negative health outcomes such as hospital readmission. The purpose of the present study was to examine the prevalence of inadequate health literacy, the reliability of the Dutch HF Knowledge Scale (DHFKS) and the Self-care of Heart Failure Index (SCHFI), and the differences in HF knowledge, HF self-care, and 30-day readmission rate by health literacy level among patients hospitalized with HF. The convenience sample included adults (n = 95) admitted to a large, urban, teaching hospital whose primary diagnosis was HF. Measures included the Short Test of Functional Health Literacy in Adults, the DHFKS, the SCHFI, and readmission at 30 days after discharge. The sample was 59 ± 14 years in age, 51% male, and 67% African American; 35% had less than a high school education, 35% were employed, 73% lived with someone who helps with their HF care, and 16% were readmitted within 30 days of index admission. Health literacy was inadequate for 42%, marginal for 19%, and adequate for 39%. Reliability of the DHFKS and SCHFI scales was comparable to prior reports. Mean knowledge score was 11.43 ± 2.26; SCHFI subscale scores were 56.82 ± 17.12 for maintenance, 63.64 ± 18.29 for management, and 65.02 ± 16.34 for confidence. Those with adequate health literacy were younger and had higher education level, HF knowledge scores, and HF self-care confidence compared with those with marginal or inadequate health literacy. Self-care maintenance and management scores and 30-day readmission rate did not differ by health literacy level. These findings demonstrate the high prevalence of inadequate and marginal health literacy and that health literacy is an important consideration in promoting HF knowledge and confidence in self-care behaviors, particularly among older adults and those with less than a high school education.

  20. The 2005 USDA Food Guide Pyramid is associated with more adequate nutrient intakes within energy constraints than the 1992 Pyramid.

    PubMed

    Gao, Xiang; Wilde, Parke E; Lichtenstein, Alice H; Tucker, Katherine L

    2006-05-01

    The USDA issued the Food Guide Pyramid (FGP) to help Americans choose healthy diets. We examined whether adherence to the 1992 and 2005 FGP was associated with moderate energy and adequate nutrient intakes. We used data for 2138 men and 2213 women > 18 y old, from the 2001-2002 U.S. National Health and Nutrition Examination Survey (NHANES). Quadratic programming was used to generate diets with minimal departure from intakes reported for the NHANES 2001-02. We examined the effect of the number of servings/d of Food Pyramid groups set at 1992 and at 2005 FGP recommendations for 1600, 2200, and 2800 kcal (1 kcal = 4.184 kJ) levels. We calculated energy and nutrients provided by different FGP dietary patterns. Within current U.S. dietary practices, following the 1992 FGP without sodium restriction may provide 200 more kcal than recommended for each energy level. Although it can meet most of old nutrient recommendations (1989), it fails to meet the latest dietary reference intakes, especially for the 1600 kcal level. The 2005 FGP appears to provide less energy and more adequate nutrient intakes, with the exception of vitamin E and potassium for some groups. However, without discretionary energy restriction, Americans are at risk of having excessive energy intake even if they follow the 2005 FGP food serving recommendations. Our analysis suggests that following the 2005 FGP may be associated with lower energy and optimal nutrient intake. Careful restriction of discretionary calories appears necessary for appropriate energy intakes to be maintained.

  1. Clinical Trials in Vision Research

    MedlinePlus

    ... What is a clinical trial? Clinical trials are medical research studies in which people volunteer to participate. A ... or treat an eye disease or disorder. Generally, medical research begins in laboratories. After a treatment shows promise ...

  2. Power Play.

    ERIC Educational Resources Information Center

    Aho, Timothy A.

    1998-01-01

    Describes how to integrate technology into old buildings beginning with an evaluation of the electric power systems. A case study is highlighted showing the process in determining existing conditions, assessing electric power needs, and designing upgrades. (GR)

  3. Statistical Power of Randomization Tests Used with Multiple-Baseline Designs.

    ERIC Educational Resources Information Center

    Ferron, John; Sentovich, Chris

    2002-01-01

    Estimated statistical power for three randomization tests used with multiple-baseline designs using Monte Carlo methods. For an effect size of 0.5, none of the tests provided an adequate level of power, and for an effect size of 1.0, power was adequate for the Koehler-Levin test and the Marascuilo-Busk test only when the series length was long and…

  4. Pulsed power

    NASA Astrophysics Data System (ADS)

    Stone, David H.

    Pulsed power systems are critical elements for such prospective weapons technologies as high-power microwaves, electrothermal and electromagnetic projectile launchers, neutral particle beams, space-based FELs, ground-based lasers, and charged particle beams. Pulsed power will also be essential for the development of nonweapon military systems such as lidars and ultrawideband radars, and could serve as the bases for nuclear weapon effect simulators. The pulsed power generation requirements for each of these systems is considered.

  5. Power processing

    NASA Technical Reports Server (NTRS)

    Schwarz, F. C.

    1971-01-01

    Processing of electric power has been presented as a discipline that draws on almost every field of electrical engineering, including system and control theory, communications theory, electronic network design, and power component technology. The cost of power processing equipment, which often equals that of expensive, sophisticated, and unconventional sources of electrical energy, such as solar batteries, is a significant consideration in the choice of electric power systems.

  6. Space Power

    NASA Technical Reports Server (NTRS)

    1984-01-01

    Appropriate directions for the applied research and technology programs that will develop space power systems for U.S. future space missions beyond 1995 are explored. Spacecraft power supplies; space stations, space power reactors, solar arrays, thermoelectric generators, energy storage, and communication satellites are among the topics discussed.

  7. Power supply

    DOEpatents

    Yakymyshyn, Christopher Paul; Hamilton, Pamela Jane; Brubaker, Michael Allen

    2007-12-04

    A modular, low weight impedance dropping power supply with battery backup is disclosed that can be connected to a high voltage AC source and provide electrical power at a lower voltage. The design can be scaled over a wide range of input voltages and over a wide range of output voltages and delivered power.

  8. The Trial of Katherine Harrison.

    ERIC Educational Resources Information Center

    Woodward, Walter W.

    2003-01-01

    Presents a lesson plan in which the teacher and students participate in a mock trial of Katherine Harrison, who was accused of witchcraft in the seventeenth century. Provides background information about the trial, as well as primary sources of the testimonies given by witnesses during the trial. (CMK)

  9. Bibliography of Mock Trial Materials.

    ERIC Educational Resources Information Center

    National Inst. for Citizen Education in the Law, Washington, DC.

    This catalog lists general articles on mock trials, information for arranging mock trial competitions, mock trial problem sets, and video tapes. The problem sets contain introductory material, applicable law, statements of facts, witness statements, and documents. The cases include issues in family, consumer, criminal, and immigration law. Several…

  10. Improving transparency of clinical trials.

    PubMed

    Dal-Ré, Rafael

    2015-06-01

    Recent data reveal that subtle selective publication affects critical aspects of trial reporting, in some cases altering the interpretation of results. Timely prospective registration could help deter selective reporting and clinical trial stakeholders from government authorities to journal editors should work together to foster prospective registration of trials.

  11. [PRIMER FOR SURGICAL CLINICAL TRIALS].

    PubMed

    Sakamaki, Kentaro; Yamanaka, Takeharu

    2016-01-01

    Clinical trials are conducted based on the development of surgical technology and are designed to answer specific research questions. In planning clinical trials population, intervention, comparison, and outcome are important elements. Sample size calculation is also central to the design of clinical trials, especially randomized, controlled ones. This article outlines study phases, four important elements of design, and sample size calculation.

  12. Accuracy of effect size estimates from published psychological experiments involving multiple trials.

    PubMed

    Brand, Andrew; Bradley, M T; Best, Lisa A; Stoica, George

    2011-01-01

    The reporting of exaggerated effect size estimates may occur either through researchers accepting statistically significant results when power is inadequate and/or from repeated measures approaches aggregating, averaging multiple items, or multiple trials. Monte-Carlo simulations with input of a small, medium, or large effect size were conducted on multiple items or trials that were either averaged or aggregated to create a single dependent measure. Alpha was set at the .05 level, and the trials were assessed over item or trial correlations ranging from 0 to 1. Simulations showed a large increase in observed effect size averages and the power to accept these estimates as statistically significant increased over numbers of trials or items. Overestimation effects were mitigated as correlations between trials increased but still remained substantial in some cases. The implications of these findings for meta-analyses and different research scenarios are discussed.

  13. The Effects of Cold Water Immersion after Rugby Training on Muscle Power and Biochemical Markers

    PubMed Central

    Takeda, Masaki; Sato, Takashi; Hasegawa, Tatsushi; Shintaku, Hiroto; Kato, Hisashi; Yamaguchi, Yoshihiko; Radak, Zsolt

    2014-01-01

    During rugby game, or intensive rugby training there are many high intensity explosive exercises and eccentric muscle contractions, therefore adequate recovery is very important to rugby players. In the present study we have tested the effects of cold water immersion (CWI) after game-simulated (80 min.) rugby training on muscle power recovery and blood markers of muscle damage. Twenty well-trained collegiate male rugby players (age: 20.3 ± 0.6 years old, body height: 1.74 ± 0.05 m, body weight: 85.4 ± 2.0 kg, body fat: 18.2 ± 1.4 %) volunteered for this study. This study was conducted as a cross-over design; i.e., the subjects were randomly assigned either to CWI (n = 10) or passive rest condition (n = 10) for the 1st trial and 1 week later the subjects were switched conditions for the 2nd trial. After the simulated rugby training, including tackles and body contacts, muscle functional ability and blood markers of muscle damage were tested immediately, after CWI or passive rest, and again 24 hours later. Statistical analysis of all muscle functional tests (10 m dash, counter movement jump, reaction time, side steps) except for 10 seconds maximal pedaling power and blood makers of muscle damage (aspartate aminotransferase, lactate dehydrogenase, creatine kinase, and creatinine) revealed significant main effects for time (p < 0.05). However, no statistically significant interactions were found in any of the muscle functional tests and blood markers between groups and time courses. Our results suggest that a rugby game induces muscle damage and reduces muscle function. However, CWI has no significant restorative effect after an 80-minute rugby game in terms of muscle damage. Key Points Cold water immersion study for the recovery of rugby players Muscle strength and muscle power were mainly evaluated as well as muscle enzymes of muscle break down Subjects were highly trained rugby players with control group PMID:25177190

  14. The Role of Systematic Reviews in Pharmacovigilance Planning and Clinical Trials Authorisation Application: Example from the SLEEPS Trial

    PubMed Central

    Gamble, Carrol; Wolf, Andrew; Sinha, Ian; Spowart, Catherine; Williamson, Paula

    2013-01-01

    Background Adequate sedation is crucial to the management of children requiring assisted ventilation on Paediatric Intensive Care Units (PICU). The evidence-base of randomised controlled trials (RCTs) in this area is small and a trial was planned to compare midazolam and clonidine, two sedatives widely used within PICUs neither of which being licensed for that use. The application to obtain a Clinical Trials Authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) required a dossier summarising the safety profiles of each drug and the pharmacovigilance plan for the trial needed to be determined by this information. A systematic review was undertaken to identify reports relating to the safety of each drug. Methodology/Principal Findings The Summary of Product Characteristics (SmPC) were obtained for each sedative. The MHRA were requested to provide reports relating to the use of each drug as a sedative in children under the age of 16. Medline was searched to identify RCTs, controlled clinical trials, observational studies, case reports and series. 288 abstracts were identified for midazolam and 16 for clonidine with full texts obtained for 80 and 6 articles respectively. Thirty-three studies provided data for midazolam and two for clonidine. The majority of data has come from observational studies and case reports. The MHRA provided details of 10 and 3 reports of suspected adverse drug reactions. Conclusions/Significance No adverse reactions were identified in addition to those specified within the SmPC for the licensed use of the drugs. Based on this information and the wide spread use of both sedatives in routine practice the pharmacovigilance plan was restricted to adverse reactions. The Clinical Trials Authorisation was granted based on the data presented in the SmPC and the pharmacovigilance plan within the clinical trial protocol restricting collection and reporting to adverse reactions. PMID:23554852

  15. Patient-reported outcomes in clinical trials of CKD-related therapies: report of a symposium sponsored by the national kidney foundation and the U.S. Food and Drug Administration.

    PubMed

    Perrone, Ronald D; Coons, Stephen Joel; Cavanaugh, Kerri; Finkelstein, Fred; Meyer, Klemens B

    2013-12-01

    The National Kidney Foundation and the U.S. Food and Drug Administration (FDA) convened a symposium in September 2010, bringing together more than 70 experts, including representatives from the FDA, the National Institutes of Health, the Critical Path Institute, nephrologists, patients, and the pharmaceutical industry to discuss the feasibility and process of developing patient-reported outcome (PRO) measures to access how patients feel or function to be used in clinical trials for regulatory review of treatment benefit. Three disease areas were evaluated for development of end point models in which PRO measures may be useful: anemia secondary to chronic kidney disease, autosomal dominant polycystic kidney disease (ADPKD), and nephrotic syndrome. The participants thought it valuable to use observational data to generate hypotheses regarding patient baseline characteristics that are likely to predict clinically important changes in PROs in response to anemia treatment and to design adequately powered blinded randomized controlled trials of anemia treatment using PROs as primary rather than secondary end points. Validated PRO instruments that reflect the patient experience in ADPKD and nephrotic syndrome are essential to incorporate into clinical trials of new therapeutic interventions because glomerular filtration rate decline may occur late in the disease course, at which point therapeutic benefit is less likely. Conference attendees addressed how PRO measures could be used to evaluate, monitor, provide care, and facilitate the introduction of treatments for patients with these challenging conditions.

  16. Evidence and Clinical Trials.

    NASA Astrophysics Data System (ADS)

    Goodman, Steven N.

    1989-11-01

    This dissertation explores the use of a mathematical measure of statistical evidence, the log likelihood ratio, in clinical trials. The methods and thinking behind the use of an evidential measure are contrasted with traditional methods of analyzing data, which depend primarily on a p-value as an estimate of the statistical strength of an observed data pattern. It is contended that neither the behavioral dictates of Neyman-Pearson hypothesis testing methods, nor the coherency dictates of Bayesian methods are realistic models on which to base inference. The use of the likelihood alone is applied to four aspects of trial design or conduct: the calculation of sample size, the monitoring of data, testing for the equivalence of two treatments, and meta-analysis--the combining of results from different trials. Finally, a more general model of statistical inference, using belief functions, is used to see if it is possible to separate the assessment of evidence from our background knowledge. It is shown that traditional and Bayesian methods can be modeled as two ends of a continuum of structured background knowledge, methods which summarize evidence at the point of maximum likelihood assuming no structure, and Bayesian methods assuming complete knowledge. Both schools are seen to be missing a concept of ignorance- -uncommitted belief. This concept provides the key to understanding the problem of sampling to a foregone conclusion and the role of frequency properties in statistical inference. The conclusion is that statistical evidence cannot be defined independently of background knowledge, and that frequency properties of an estimator are an indirect measure of uncommitted belief. Several likelihood summaries need to be used in clinical trials, with the quantitative disparity between summaries being an indirect measure of our ignorance. This conclusion is linked with parallel ideas in the philosophy of science and cognitive psychology.

  17. Innovative Clinical Trial Designs

    PubMed Central

    Lavori, Philip W.

    2015-01-01

    Whereas the 20th-century health care system sometimes seemed to be inhospitable to and unmoved by experimental research, its inefficiency and unaffordability have led to reforms that foreshadow a new health care system. We point out certain opportunities and transformational needs for innovations in study design offered by the 21st-century health care system, and describe some innovative clinical trial designs and novel design methods to address these needs and challenges. PMID:26140056

  18. A randomised controlled trial of nurse-managed trial conclusion following early phase cancer trial participation.

    PubMed

    Cox, K; Wilson, E; Arthur, A; Elkan, R; Armstrong, S

    2005-07-11

    The effect of a nurse-managed intervention, for early phase cancer trial participants at trial conclusion, on psychosocial outcomes was evaluated at two cancer centres in the Midlands, England using a randomised controlled trial. It involved 117 patients who were participating in an early phase cancer clinical trial. It was a nurse-managed trial exit, which included a trial exit interview, trial feedback information leaflet and telephone follow-up compared with standard care at trial conclusion. Psychological distress at 1 week and 4-6 weeks post-trial conclusion, patient's knowledge and understanding and patient's satisfaction were assessed. The results showed there was no significant difference between the two groups regarding scores for anxiety and depression at time one and time two. There is some suggestion that the intervention reduced anxiety from trial conclusion to follow-up (P=0.27). Patients in both groups felt they had contributed to cancer research through trial participation. However, intervention patients were more likely to feel that they knew how the trial was going (P<0.001), knew how other people in the trial were doing (P=0.001), had all the feedback they needed about the trial they took part in (P<0.01) and knew how they would be followed up (P=0.02). Patient satisfaction with the intervention was high (median score=4.5 where 5 is greatest satisfaction). In conclusion, nurse-managed trial conclusion led to positive outcomes for patients who had recently completed a clinical trial.

  19. 14 CFR 23.1331 - Instruments using a power source.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false Instruments using a power source. 23.1331... where it enters the instrument. For electric and vacuum/pressure instruments, the power is considered to be adequate when the voltage or the vacuum/pressure, respectively, is within approved limits. (b)...

  20. 14 CFR 23.1331 - Instruments using a power source.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 1 2012-01-01 2012-01-01 false Instruments using a power source. 23.1331 Section 23.1331 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION... vacuum/pressure instruments, the power is considered to be adequate when the voltage or the...

  1. Gateways to clinical trials.

    PubMed

    Bayés, M; Rabasseda, X; Prous, J R

    2007-01-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issues focuses on the following selection of drugs: 4'-Thio-ara-C, 5-methyltetrahydrofolate; ABT-089, AD-237, AF-37702, alvocidib hydrochloride, apricitabine, armodafinil, atrasentan, AVE-5883, avian influenza vaccine, azimilide hydrochloride; Banoxantrone, BIBF-1120; CD34+ cells, certolizumab pegol, CHIR-258, cilansetron, CoFactor, CX-3543, cystemustine; D-003, dexloxiglumide, DMXB-anabaseine; Ecogramostim, elcometrine, elcometrine/ethinylestradiol, etravirine; Fenretinide, fingolimod hydrochloride, fospropofol disodium; Gaboxadol, gestodene, glutamine; Human insulin, hyaluronic acid; Incyclinide, indacaterol, ispronicline, istradefylline; Labradimil, lamifiban, lapatinib, L-arginine hydrochloride, liposomal cisplatin, liposome encapsulated paclitaxel, LY-517717; Manidipine hydrochloride/delapril hydrochloride, maraviroc, MBP(82-98), MD-0727, MDX-214, melanotan I, MMR vaccine; Nacystelyn, nalfurafine hydrochloride, nibentan, nilotinib, NK-105; OBI-1, oblimersen sodium, olmesartan medoxomil, olmesartan medoxomil/hydrochlorothiazide, oregovomab; Pexelizumab, PG-116800, PG-CPT, PHA-794428, prasugrel; RC-3095, rDNA insulin, RFB4(dsFv)-PE38, rhEndostatin, rhenium Re-186 etidronate, rhGM-CSF, roflumilast, romidepsin; Sarcosine, SGLU1, SGN-40, succinobucol; TAU, teduglutide, telatinib, tesofensine, tipifarnib, tirapazamine, TKA-731, tolvaptan, trabectedin; Vaccimel, vatalanib succinate, velafermin, vildagliptin, vinflunine; XP-19986; YM-155.

  2. The two-layer geochemical structure of modern biogeochemical provinces and its significance for spatially adequate ecological evaluations and decisions

    NASA Astrophysics Data System (ADS)

    Korobova, Elena; Romanov, Sergey

    2014-05-01

    Contamination of the environment has reached such a scale that ecogeochemical situation in any area can be interpreted now as a result of the combined effect of natural and anthropogenic factors. The areas that appear uncomfortable for a long stay can have natural and anthropogenic genesis, but the spatial structure of such biogeochemical provinces is in any case formed of a combination of natural and technogenic fields of chemical elements. Features of structural organization and the difference in factors and specific time of their formation allow their separation on one hand and help in identification of areas with different ecological risks due to overlay of the two structures on the other. Geochemistry of soil cover reflects the long-term result of the naturally balanced biogeochemical cycles, therefore the soil geochemical maps of the undisturbed areas may serve the basis for evaluation of the natural geochemical background with due regard to the main factors of geochemical differentiation in biosphere. Purposeful and incidental technogenic concentrations and dispersions of chemical elements of specific (mainly mono- or polycentric) structure are also fixed in soils that serve as secondary sources of contamination of the vegetation cover and local food chains. Overlay of the two structures forms specific heterogeneity of modern biogeochemical provinces with different risk for particular groups of people, animals and plants adapted to specific natural geochemical background within particular concentration interval. The developed approach is believed to be helpful for biogeochemical regionalizing of modern biosphere (noosphere) and for spatially adequate ecogeochemical evaluation of the environment and landuse decisions. It allows production of a set of applied geochemical maps such as: 1) health risk due to chemical elements deficiency and technogenic contamination accounting of possible additive effects; 2) adequate soil fertilization and melioration with due

  3. Knowledge and Informed Decision-Making about Population-Based Colorectal Cancer Screening Participation in Groups with Low and Adequate Health Literacy

    PubMed Central

    Essink-Bot, M. L.; Dekker, E.; Timmermans, D. R. M.; Uiters, E.; Fransen, M. P.

    2016-01-01

    Objective. To analyze and compare decision-relevant knowledge, decisional conflict, and informed decision-making about colorectal cancer (CRC) screening participation between potential screening participants with low and adequate health literacy (HL), defined as the skills to access, understand, and apply information to make informed decisions about health. Methods. Survey including 71 individuals with low HL and 70 with adequate HL, all eligible for the Dutch organized CRC screening program. Knowledge, attitude, intention to participate, and decisional conflict were assessed after reading the standard information materials. HL was assessed using the Short Assessment of Health Literacy in Dutch. Informed decision-making was analyzed by the multidimensional measure of informed choice. Results. 64% of the study population had adequate knowledge of CRC and CRC screening (low HL 43/71 (61%), adequate HL 47/70 (67%), p > 0.05). 57% were informed decision-makers (low HL 34/71 (55%), adequate HL 39/70 (58%), p > 0.05). Intention to participate was 89% (low HL 63/71 (89%), adequate HL 63/70 (90%)). Respondents with low HL experienced significantly more decisional conflict (25.8 versus 16.1; p = 0.00). Conclusion. Informed decision-making about CRC screening participation was suboptimal among both individuals with low HL and individuals with adequate HL. Further research is required to develop and implement effective strategies to convey decision-relevant knowledge about CRC screening to all screening invitees. PMID:27200089

  4. Fair Balance and Adequate Provision in Direct-to-Consumer Prescription Drug Online Banner Advertisements: A Content Analysis

    PubMed Central

    2016-01-01

    Background The current direct-to-consumer advertising (DTCA) guidelines were developed with print, television, and radio media in mind, and there are no specific guidelines for online banner advertisements. Objective This study evaluates how well Internet banner ads comply with existing Food and Drug Administration (FDA) guidelines for DTCA in other media. Methods A content analysis was performed of 68 banner advertisements. A coding sheet was developed based on (1) FDA guidance documents for consumer-directed prescription drug advertisements and (2) previous DTCA content analyses. Specifically, the presence of a brief summary detailing the drug’s risks and side effects or of a “major statement” identifying the drug’s major risks, and the number and type of provisions made available to consumers for comprehensive information about the drug were coded. In addition, the criterion of “fair balance,” the FDA’s requirement that prescription drug ads balance information relating to the drug’s risks with information relating to its benefits, was measured by numbering the benefit and risk facts identified in the ads and by examining the presentation of risk and benefit information. Results Every ad in the sample included a brief summary of risk information and at least one form of adequate provision as required by the FDA for broadcast ads that do not give audiences a brief summary of a drug’s risks. No ads included a major statement. There were approximately 7.18 risk facts for every benefit fact. Most of the risks (98.85%, 1292/1307) were presented in the scroll portion of the ad, whereas most of the benefits (66.5%, 121/182) were presented in the main part of the ad. Out of 1307 risk facts, 1292 were qualitative and 15 were quantitative. Out of 182 benefit facts, 181 were qualitative and 1 was quantitative. The majority of ads showed neutral images during the disclosure of benefit and risk facts. Only 9% (6/68) of the ads displayed positive images and

  5. Low rate of large polyps (>9 mm) within 10 years after an adequate baseline colonoscopy with no polyps

    PubMed Central

    Lieberman, David; Holub, Jennifer L.; Morris, Cynthia D.; Logan, Judith; Williams, J. Lucas; Carney, Patricia

    2014-01-01

    Background & Aims Guidelines recommend a 10 year interval between screening colonoscopies with negative results for average-risk individuals. However, many patients are examined at shorter intervals. We investigated outcomes of individuals with no polyps who had repeat colonoscopy in less than 10 years. Methods Data were collected using the National Endoscopic Database, from 69 gastroenterology centers, on 264,184 asymptomatic subjects who underwent screening colonoscopies from 2000 through 2006, were found to have no polyps, and received another colonoscopy examination within less than 10 years. Results No polyps were found in 147,375 patients during a baseline colonoscopy; 17,525 patients (11.9%) had a follow-up colonoscopy within less than 10 years, including 1806 (10.3%) who received the follow-up colonoscopy within less than 1 year. The most common reason for repeating the examination within 1 year was that the first was compromised by inadequate bowel preparation or incomplete examination. Of these patients, 6.5% (95% confidence interval [CI], 5.3–7.6) had large polyp(s) >9 mm—a proportion similar to the prevalence in the average-risk screening population. Reasons that examinations were repeated within 1–5 years included average-risk screening (15.7%), family history of colon polyps or cancer (30.1%), bleeding (31.2%), gastrointestinal symptoms (11.8%), or a positive result from a fecal blood test (5.5%). If the baseline exam was adequate, the incidence of large polyps within 1–5 years after baseline colonoscopy was 3.1% (95% CI, 2.7–3.5) and within years 5–10 years was 3.7% (95% CI, 3.3–4.1). Conclusions Repeat colonoscopies within 10 years are of no benefit to patients who had adequate examinations and were found to have no polyps. Repeat colonoscopies are beneficial to patients when the baseline examination was compromised. PMID:24768680

  6. Involving regional expertise in nationwide modeling for adequate prediction of climate change effects on different demands for fresh water

    NASA Astrophysics Data System (ADS)

    de Lange, W. J.

    2014-05-01

    Wim J. de Lange, Geert F. Prinsen, Jacco H. Hoogewoud, Ab A Veldhuizen, Joachim Hunink, Erik F.W. Ruijgh, Timo Kroon Nationwide modeling aims to produce a balanced distribution of climate change effects (e.g. harm on crops) and possible compensation (e.g. volume fresh water) based on consistent calculation. The present work is based on the Netherlands Hydrological Instrument (NHI, www.nhi.nu), which is a national, integrated, hydrological model that simulates distribution, flow and storage of all water in the surface water and groundwater systems. The instrument is developed to assess the impact on water use on land-surface (sprinkling crops, drinking water) and in surface water (navigation, cooling). The regional expertise involved in the development of NHI come from all parties involved in the use, production and management of water, such as waterboards, drinking water supply companies, provinces, ngo's, and so on. Adequate prediction implies that the model computes changes in the order of magnitude that is relevant to the effects. In scenarios related to drought, adequate prediction applies to the water demand and the hydrological effects during average, dry, very dry and extremely dry periods. The NHI acts as a part of the so-called Deltamodel (www.deltamodel.nl), which aims to predict effects and compensating measures of climate change both on safety against flooding and on water shortage during drought. To assess the effects, a limited number of well-defined scenarios is used within the Deltamodel. The effects on demand of fresh water consist of an increase of the demand e.g. for surface water level control to prevent dike burst, for flushing salt in ditches, for sprinkling of crops, for preserving wet nature and so on. Many of the effects are dealt with by regional and local parties. Therefore, these parties have large interest in the outcome of the scenario analyses. They are participating in the assessment of the NHI previous to the start of the analyses

  7. Involving regional expertise in nationwide modeling for adequate prediction of climate change effects on different demands for fresh water

    NASA Astrophysics Data System (ADS)

    de Lange, Wim; Prinsen, Geert.; Hoogewoud, Jacco; Veldhuizen, Ab; Ruijgh, Erik; Kroon, Timo

    2013-04-01

    Nationwide modeling aims to produce a balanced distribution of climate change effects (e.g. harm on crops) and possible compensation (e.g. volume fresh water) based on consistent calculation. The present work is based on the Netherlands Hydrological Instrument (NHI, www.nhi.nu), which is a national, integrated, hydrological model that simulates distribution, flow and storage of all water in the surface water and groundwater systems. The instrument is developed to assess the impact on water use on land-surface (sprinkling crops, drinking water) and in surface water (navigation, cooling). The regional expertise involved in the development of NHI come from all parties involved in the use, production and management of water, such as waterboards, drinking water supply companies, provinces, ngo's, and so on. Adequate prediction implies that the model computes changes in the order of magnitude that is relevant to the effects. In scenarios related to drought, adequate prediction applies to the water demand and the hydrological effects during average, dry, very dry and extremely dry periods. The NHI acts as a part of the so-called Deltamodel (www.deltamodel.nl), which aims to predict effects and compensating measures of climate change both on safety against flooding and on water shortage during drought. To assess the effects, a limited number of well-defined scenarios is used within the Deltamodel. The effects on demand of fresh water consist of an increase of the demand e.g. for surface water level control to prevent dike burst, for flushing salt in ditches, for sprinkling of crops, for preserving wet nature and so on. Many of the effects are dealt with? by regional and local parties. Therefore, these parties have large interest in the outcome of the scenario analyses. They are participating in the assessment of the NHI previous to the start of the analyses. Regional expertise is welcomed in the calibration phase of NHI. It aims to reduce uncertainties by improving the

  8. Healthcare Costs Associated with an Adequate Intake of Sugars, Salt and Saturated Fat in Germany: A Health Econometrical Analysis.

    PubMed

    Meier, Toni; Senftleben, Karolin; Deumelandt, Peter; Christen, Olaf; Riedel, Katja; Langer, Martin

    2015-01-01

    Non-communicable diseases (NCDs) represent not only the major driver for quality-restricted and lost life years; NCDs and their related medical treatment costs also pose a substantial economic burden on healthcare and intra-generational tax distribution systems. The main objective of this study was therefore to quantify the economic burden of unbalanced nutrition in Germany--in particular the effects of an excessive consumption of fat, salt and sugar--and to examine different reduction scenarios on this basis. In this study, the avoidable direct cost savings in the German healthcare system attributable to an adequate intake of saturated fatty acids (SFA), salt and sugar (mono- & disaccharides, MDS) were calculated. To this end, disease-specific healthcare cost data from the official Federal Health Monitoring for the years 2002-2008 and disease-related risk factors, obtained by thoroughly searching the literature, were used. A total of 22 clinical endpoints with 48 risk-outcome pairs were considered. Direct healthcare costs attributable to an unbalanced intake of fat, salt and sugar are calculated to be 16.8 billion EUR (CI95%: 6.3-24.1 billion EUR) in the year 2008, which represents 7% (CI95% 2%-10%) of the total treatment costs in Germany (254 billion EUR). This is equal to 205 EUR per person annually. The excessive consumption of sugar poses the highest burden, at 8.6 billion EUR (CI95%: 3.0-12.1); salt ranks 2nd at 5.3 billion EUR (CI95%: 3.2-7.3) and saturated fat ranks 3rd at 2.9 billion EUR (CI95%: 32 million-4.7 billion). Predicted direct healthcare cost savings by means of a balanced intake of sugars, salt and saturated fat are substantial. However, as this study solely considered direct medical treatment costs regarding an adequate consumption of fat, salt and sugars, the actual societal and economic gains, resulting both from direct and indirect cost savings, may easily exceed 16.8 billion EUR.

  9. Structural and functional MRI study of the brain, cognition and mood in long-term adequately treated Hashimoto's thyroiditis.

    PubMed

    Quinque, Eva M; Karger, Stefan; Arélin, Katrin; Schroeter, Matthias L; Kratzsch, Jürgen; Villringer, Arno

    2014-04-01

    The current study investigated neuropsychological and underlying structural and functional brain alterations in long-term adequately treated patients with Hashimoto's thyroiditis in order to examine much discussed residual complaints in patients in relation to possible long-term neural alterations with a specific interest in the underlying autoimmune process. Eighteen patients with treated hypothyroidism due to Hashimoto's thyroiditis (mean age 32, range 18-54 years; two males; mean treatment duration 4.4 years) and 18 healthy matched control subjects underwent 3-Tesla magnetic resonance imaging (MRI). Voxel-based morphometry was used to investigate grey matter density, resting-state functional MRI to analyse the brain connectivity of areas known to be altered in hypothyroidism and event-related functional MRI to examine brain activity during associative memory encoding. Neuropsychological assessment included memory, working memory, psychomotor speed and attention. We previously reported subclinically reduced mood in this study population and investigated its neural correlates here. Thyroid stimulating hormone, free triiodthyronine, free thyroxine and thyroid peroxidase antibodies were measured in serum. We did not find cognitive deficits or alterations in grey matter density, functional connectivity or associative memory-related brain activity in comparison to the control group and cognition was unrelated to thyroid serum measures in the patient group. Thyroid peroxidase antibodies in the patient group correlated with increased grey matter density in right amygdala and enhanced connectivity between subcallosal and parahippocampal areas. Treatment duration was associated with brain structure in frontal and occipital cortex and connectivity between left amygdala and frontal cortex. Mood correlated with brain areas associated with distinct functional networks, but not with those most prominently affected in depression. In conclusion, no cognitive or neural

  10. SMi's Conducting Clinical Trials in Europe.

    PubMed

    Jago, Charlotte

    2009-12-01

    The Conducting Clinical Trials in Europe meeting, held in London, included topics covering new developments in the field of clinical trials and recommendations on how to best conduct a trial. This conference report highlights selected presentations on the state of affairs of trials in Europe, conducting trials in emerging markets, strategies for improving trials, trial design options, peri-approval and pediatric trials, and the role of key players, such as physicians. Company perspectives from Pfizer Inc and Nycomed are also included.

  11. The Internet and Clinical Trials: Background, Online Resources, Examples and Issues

    PubMed Central

    Seib, Rachael; Prescott, Todd

    2005-01-01

    Both the Internet and clinical trials were significant developments in the latter half of the twentieth century: the Internet revolutionized global communications and the randomized controlled trial provided a means to conduct an unbiased comparison of two or more treatments. Large multicenter trials are often burdened with an extensive development time and considerable expense, as well as significant challenges in obtaining, backing up and analyzing large amounts of data. Alongside the increasing complexities of the modern clinical trial has grown the power of the Internet to improve communications, centralize and secure data as well as to distribute information. As more and more clinical trials are required to coordinate multiple trial processes in real time, centers are turning to the Internet for the tools to manage the components of a clinical trial, either in whole or in part, to produce lower costs and faster results. This paper reviews the historical development of the Internet and the randomized controlled trial, describes the Internet resources available that can be used in a clinical trial, reviews some examples of online trials and describes the advantages and disadvantages of using the Internet to conduct a clinical trial. We also extract the characteristics of the 5 largest clinical trials conducted using the Internet to date, which together enrolled over 26000 patients. PMID:15829477

  12. The Internet and clinical trials: background, online resources, examples and issues.

    PubMed

    Paul, James; Seib, Rachael; Prescott, Todd

    2005-03-16

    Both the Internet and clinical trials were significant developments in the latter half of the twentieth century: the Internet revolutionized global communications and the randomized controlled trial provided a means to conduct an unbiased comparison of two or more treatments. Large multicenter trials are often burdened with an extensive development time and considerable expense, as well as significant challenges in obtaining, backing up and analyzing large amounts of data. Alongside the increasing complexities of the modern clinical trial has grown the power of the Internet to improve communications, centralize and secure data as well as to distribute information. As more and more clinical trials are required to coordinate multiple trial processes in real time, centers are turning to the Internet for the tools to manage the components of a clinical trial, either in whole or in part, to produce lower costs and faster results. This paper reviews the historical development of the Internet and the randomized controlled trial, describes the Internet resources available that can be used in a clinical trial, reviews some examples of online trials and describes the advantages and disadvantages of using the Internet to conduct a clinical trial. We also extract the characteristics of the 5 largest clinical trials conducted using the Internet to date, which together enrolled over 26000 patients.

  13. Is autologous chondrocyte implantation (ACI) an adequate treatment option for repair of cartilage defects in paediatric patients?

    PubMed

    Kaszkin-Bettag, Marietta

    2013-08-01

    Cartilage lesions in the knee of juvenile patients require an effective repair to regain life-long functional activity of the joint. Autologous chondrocyte implantation (ACI) is discussed to be advantageous over other methods for cartilage repair regarding long-term outcome. ACI has successfully been applied in juvenile patients, although currently recommended for patients ≥18 years of age. Only few controlled clinical trials present evidence of efficacy and safety of ACI in adolescent patients. ACI products have to undergo the process of a marketing authorisation application, including the submission of a paediatric investigation plan (PIP). Data from prospective clinical studies or retrospective collection of long-term data in paediatric patients should be submitted for risk-benefit evaluation by the Paediatric Committee (PDCO).

  14. New Trends in Clinical Trials: A Conversation with Pfizer's Craig Lipset.

    PubMed

    Bates, Mary

    2016-01-01

    Technological advances, such as electronic data capture and the prevalence of Wi-Fi connectivity, are driving changes in how clinical trials are conducted and analyzed. As the power to track and analyze data expands, clinical trials are becoming more efficient and objective, and patient experiences are improved.

  15. Randomized controlled trials in frontotemporal dementia: cognitive and behavioral outcomes

    PubMed Central

    2014-01-01

    Progress has been made in understanding the genetics and molecular biology of frontotemporal dementia (FTD). Targets for intervention have been identified, therapies are being developed, and clinical trials are advancing. A major challenge for FTD research is that multiple underlying pathologies can be associated with heterogeneous phenotypes. The neuropsychological profiles associated with FTD spectrum disorders often include executive dysfunction, language impairments and behavioral disturbance. Behavioral variant FTD is characterized by an initial presentation of changes in personality, behavior and/or emotion, which are often difficult to objectively capture using traditional neuropsychological measures. The two principal language variants of FTD are Progressive Nonfluent Aphasia (PNFA) with predominant agrammatic/non-fluent impairments and Semantic Dementia (SD) with semantic impairments and visual agnosia. Selection of appropriate endpoints for clinical trials is critical to ensure that the measures are adequately sensitive to detect change, yet specific enough to isolate signal from noise, and acceptable to regulatory agencies. Given the anticipated potential for small effect sizes, measures must be able to identify small incremental changes over time. It is also imperative that the measures provide adequate coverage of the constructs or behaviors of interest. Selected outcome measures should be suitable for repeat administration, yet relatively robust to practice effects to ensure that observed changes reflect true signal variance and not residual effects due to repeated measurement or poor reliability. To facilitate widespread adoption as an endpoint, measures should be readily accessible. We provide several examples of potential global, composite, and individual cognitive measures, as well as behavioral measures promising for FTD trials. Development and application of appropriate trial outcomes is critically important to success in advancing new

  16. Adequate trust avails, mistaken trust matters: on the moral responsibility of doctors as proxies for patients' trust in biobank research.

    PubMed

    Johnsson, Linus; Helgesson, Gert; Hansson, Mats G; Eriksson, Stefan

    2013-11-01

    In Sweden, most patients are recruited into biobank research by non-researcher doctors. Patients' trust in doctors may therefore be important to their willingness to participate. We suggest a model of trust that makes sense of such transitions of trust between domains and distinguishes adequate trust from mistaken trust. The unique position of doctors implies, we argue, a Kantian imperfect duty to compensate for patients' mistaken trust. There are at least three kinds of mistaken trust, each of which requires a different set of countermeasures. First, trust is mistaken when necessary competence is lacking; the competence must be developed or the illusion dispelled. Second, trust is irrational whenever the patient is mistaken about his actual reasons for trusting. Care must therefore be taken to support the patient's reasoning and moral agency. Third, some patients inappropriately trust doctors to recommend only research that will benefit them directly. Such trust should be counteracted by nurturing a culture where patients expect to be asked occasionally to contribute to the common good.

  17. Adequate Hand Washing and Glove Use Are Necessary To Reduce Cross-Contamination from Hands with High Bacterial Loads.

    PubMed

    Robinson, Andrew L; Lee, Hyun Jung; Kwon, Junehee; Todd, Ewen; Rodriguez, Fernando Perez; Ryu, Dojin

    2016-02-01

    Hand washing and glove use are the main methods for reducing bacterial cross-contamination from hands to ready-to-eat food in a food service setting. However, bacterial transfer from hands to gloves is poorly understood, as is the effect of different durations of soap rubbing on bacterial reduction. To assess bacterial transfer from hands to gloves and to compare bacterial transfer rates to food after different soap washing times and glove use, participants' hands were artificially contaminated with Enterobacter aerogenes B199A at ∼9 log CFU. Different soap rubbing times (0, 3, and 20 s), glove use, and tomato dicing activities followed. The bacterial counts in diced tomatoes and on participants' hands and gloves were then analyzed. Different soap rubbing times did not significantly change the amount of bacteria recovered from participants' hands. Dicing tomatoes with bare hands after 20 s of soap rubbing transferred significantly less bacteria (P < 0.01) to tomatoes than did dicing with bare hands after 0 s of soap rubbing. Wearing gloves while dicing greatly reduced the incidence of contaminated tomato samples compared with dicing with bare hands. Increasing soap washing time decreased the incidence of bacteria recovered from outside glove surfaces (P < 0.05). These results highlight that both glove use and adequate hand washing are necessary to reduce bacterial cross-contamination in food service environments.

  18. Presymptomatic diagnosis with MRI and adequate treatment ameliorate the outcome after natalizumab-associated progressive multifocal leukoencephalopathy.

    PubMed

    Lindå, Hans; von Heijne, Anders

    2013-01-01

    Natalizumab (Tysabri(®)) is a monoclonal antibody that prevents inflammatory cells from binding to brain endothelial cells and passing into the brain parenchyma. Natalizumab is a highly effective treatment for relapsing-remitting multiple sclerosis (MS). Progressive multifocal leukoencephalopathy (PML) is an opportunistic brain JC virus infection that has been shown to be associated with natalizumab treatment. We describe PML in a patient with MS after 44 monthly infusions of natalizumab. With the aid of a routine Magnetic resonance imaging (MRI) scan, PML was detected before any unambiguous clinical manifestations had emerged. PML was treated with plasma exchange to accelerate removal of natalizumab. Mirtazapine and mefloquine was promptly added and approximately 1 month after plasma exchange, when an immune-reconstitution-inflammatory-syndrome appeared, steroid treatment was initiated. Steroid treatment was then continued until no virus could be detected in the cerebrospinal fluid. The outcome was favorable. We believe that this case clearly illustrates the importance of an early, presymptomatic, detection of PML, and an adequate treatment. We also propose that surveillance with MRI scans, every 3 months after 24 months of treatment, should be performed in JC virus antibody positive natalizumab-treated MS patients in order to detect PML in an early phase.

  19. TNFR2 maintains adequate IL-12 production by dendritic cells in inflammatory responses by regulating endogenous TNF levels.

    PubMed

    Martin, Elisabeth M; Remke, Annika; Pfeifer, Eva; Polz, Johannes; Pietryga-Krieger, Anne; Steffens-Weber, Dorothea; Freudenberg, Marina A; Mostböck, Sven; Männel, Daniela N

    2014-10-01

    Sepsis-induced immune reactions are reduced in TNF receptor 2 (TNFR2)-deficient mice as previously shown. In order to elucidate the underlying mechanisms, the functional integrity of myeloid cells of TNFR2-deficient mice was analyzed and compared to wild type (WT) mice. The capacity of dendritic cells to produce IL-12 was strongly impaired in TNF-deficient mice, mirroring impaired production of IL-12 by WT dendritic cells in sepsis or after LPS or TNF pre-treatment. In addition, TNFR2-deficient mice were refractory to LPS pre-treatment and also to hyper-sensitization by inactivated Propionibacterium acnes, indicating habituation to inflammatory stimuli by the immune response when TNFR2 is lacking. Constitutive expression of TNF mRNA in kidney, liver, spleen, colon and lung tissue, and the presence of soluble TNFR2 in urine of healthy WT mice supported the conclusion that TNF is continuously present in naïve mice and controlled by soluble TNFR2. In TNFR2-deficient mice endogenous TNF levels cannot be balanced and the continuous exposure to enhanced TNF levels impairs dendritic cell function. In conclusion, TNF pre-exposure suppresses secondary inflammatory reactions of myeloid cells; therefore, continuous control of endogenous TNF by soluble TNFR2 seems to be essential for the maintenance of adequate sensitivity to inflammatory stimuli.

  20. New vessel formation in the context of cardiomyocyte regeneration--the role and importance of an adequate perfusing vasculature.

    PubMed

    Michelis, Katherine C; Boehm, Manfred; Kovacic, Jason C

    2014-11-01

    The history of revascularization for cardiac ischemia dates back to the early 1960's when the first coronary artery bypass graft procedures were performed in humans. With this 50 year history of providing a new vasculature to ischemic and hibernating myocardium, a profound depth of experience has been amassed in clinical cardiovascular medicine as to what does, and does not work in the context of cardiac revascularization, alleviating ischemia and adequacy of myocardial perfusion. These issues are of central relevance to contemporary cell-based cardiac regenerative approaches. While the cardiovascular cell therapy field is surging forward on many exciting fronts, several well accepted clinical axioms related to the cardiac arterial supply appear to be almost overlooked by some of our current basic conceptual and experimental cell therapy paradigms. We present here information drawn from five decades of the clinical revascularization experience, review relevant new data on vascular formation via cell therapy, and put forward the case that for optimal cell-based cardiac regeneration due attention must be paid to providing an adequate vascular supply.