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Sample records for adequately powered trial

  1. 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…

  2. 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. PMID:25951954

  3. 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…

  4. Can loss of balance from mesoscale eddies adequately power deep ocean mixing?

    NASA Astrophysics Data System (ADS)

    Williams, P. D.; Haine, T. W.; Read, P. L.

    2009-12-01

    The global ocean thermohaline circulation is partly composed of the sinking of dense surface waters at high latitudes. But in order to close the circulation and maintain the abyssal stratification, the dense waters must rise up again through vertical mixing. This process requires a source of energy roughly estimated to be 2 TW. Previous work has concluded that tides and winds may adequately supply the required power, but the conceivable role of loss of balance from mesoscale eddies, resulting in the generation of internal inertia-gravity waves and associated vertical mixing, has hitherto been considered to be 'of unknown importance' (Wunsch and Ferrari, 2004). We investigate the potential role of loss of balance, by studying the generation of internal inertia-gravity waves by balanced flow in a rotating two-layer annulus laboratory experiment (Williams et al., 2008). A photograph from the experiment is shown in the figure. As the Rossby number of the balanced flow decreases, the amplitude of the emitted inertia-gravity waves also decreases, but much less rapidly than is predicted by several dynamical theories. This finding suggests that inertia-gravity waves might be far more energised than previously thought. The balanced flow leaks roughly one per cent of its energy each rotation period into internal inertia-gravity waves at the peak of their generation. Crude extrapolation of this result to the global ocean suggests that the flux of energy from mesoscale eddies into internal waves may be as large as 1.5 TW. We claim no accuracy for this figure which is only indicative. Nevertheless, we are persuaded that generation of inertia-gravity waves from the balanced mesoscale flow may be an important source of energy for deep interior mixing, and deserves further study. Reference Williams, PD, Haine, TWN and Read, PL (2008) Inertia-Gravity Waves Emitted from Balanced Flow: Observations, Properties, and Consequences. Journal of the Atmospheric Sciences, 65(11), pp 3543

  5. Estimating statistical power for open-enrollment group treatment trials.

    PubMed

    Morgan-Lopez, Antonio A; Saavedra, Lissette M; Hien, Denise A; Fals-Stewart, William

    2011-01-01

    Modeling turnover in group membership has been identified as a key barrier contributing to a disconnect between the manner in which behavioral treatment is conducted (open-enrollment groups) and the designs of substance abuse treatment trials (closed-enrollment groups, individual therapy). Latent class pattern mixture models (LCPMMs) are emerging tools for modeling data from open-enrollment groups with membership turnover in recently proposed treatment trials. The current article illustrates an approach to conducting power analyses for open-enrollment designs based on the Monte Carlo simulation of LCPMM models using parameters derived from published data from a randomized controlled trial comparing Seeking Safety to a Community Care condition for women presenting with comorbid posttraumatic stress disorder and substance use disorders. The example addresses discrepancies between the analysis framework assumed in power analyses of many recently proposed open-enrollment trials and the proposed use of LCPMM for data analysis. PMID:20832971

  6. The Midwest Exercise Trial for the Prevention of Weight Regain: MET POWeR.

    PubMed

    Szabo, Amanda N; Washburn, Richard A; Sullivan, Debra K; Honas, Jeffery J; Mayo, Matthew S; Goetz, Jeannine; Lee, Jaehoon; Donnelly, Joseph E

    2013-11-01

    Weight reduction in overweight and obese individuals results in physiological and behavioral changes that make the prevention of weight regain more difficult than either initial weight loss or the prevention of weight gain. Exercise is recommended for the prevention of weight regain by both governmental agencies and professional organizations. To date, the effectiveness of exercise recommendations for the prevention of weight regain has not been evaluated in a properly designed, adequately powered trial. Therefore, we will conduct a randomized trial to evaluate the effectiveness of 3 levels of exercise on the prevention of weight regain, in initially overweight and obese sedentary men and women. Participants will complete a 3 month weight loss intervention of decreased energy intake (EI) and increased exercise (100 min/week). Participants achieving clinically significant weight loss (≥ 5% of initial weight), will then be randomly assigned to 12 months of verified exercise at 3 levels (150, 225 or 300 min/week). This study will evaluate: 1) the effectiveness of 3 levels of exercise on the prevention of weight regain over 12 months subsequent to clinically significant weight loss (≥ 5%); 2) gender differences in weight regain in response to 3 levels of exercise; and 3) potential compensatory changes in daily physical activity (PA) and EI on weight regain in response to the 3 levels of exercise. The results of this investigation will provide information to develop evidence-based recommendations for the level of exercise associated with the prevention of weight regain. PMID:24012915

  7. Independent but Coordinated Trials: Insights from the Practice Based Opportunities for Weight Reduction (POWER) Trials Collaborative Research Group

    PubMed Central

    Yeh, Hsin-Chieh; Clark, Jeanne M.; Emmons, Karen M.; Moore, Renee H.; Bennett, Gary G; Warner, Erica T.; Sarwer, Davis B.; Jerome, Gerald J; Miller, Edgar R; Volger, Sheri; Louis, Thomas A.; Wells, Barbara; Wadden, Thomas A.; Colditz, Graham A.; Appel, Lawrence J.

    2011-01-01

    Background The National Heart, Lung, and Blood Institute (NHLBI) funded three institutions to conduct effectiveness trials of weight loss interventions in primary care settings. Unlike traditional multi-center clinical trials, each study was established as an independent trial with a distinct protocol. Still, efforts were made to coordinate and standardize several aspects of the trials. The three trials formed a collaborative group, the “Practice Based Opportunities for Weight Reduction (POWER) Trials Collaborative Research Group.” Purpose We describe the common and distinct features of the three trials, the key characteristics of the collaborative group, and the lessons learned from this novel organizational approach. Methods The Collaborative Research Group consists of three individual studies: “Be Fit, Be Well“(Washington University in St. Louis/Harvard University), “POWER Hopkins” (Johns Hopkins), and “POWER-UP” (University of Pennsylvania). There are a total of 15 participating clinics with ~1,100 participants. The common primary outcome is change in weight at 24 months of follow-up, but each protocol has trial-specific elements including different interventions and different secondary outcomes. A Resource Coordinating Unit at Johns Hopkins provides administrative support. Results The Collaborative Research Group established common components to facilitate potential cross-site comparisons. The main advantage of this approach is to develop and evaluate several interventions, when there is insufficient evidence to test one or two approaches, as would be done in a traditional multi-center trial. Limitations The challenges of the organizational design include the complex decision making process, the extent of potential data pooling, time intensive efforts to standardize reports, and the additional responsibilities of the DSMB to monitor three distinct protocols. Conclusions The POWER Trials Collaborative Research Group is a case study of an

  8. The statistical power and validity of Ebola vaccine trials in Sierra Leone: A simulation study of trial design and analysis

    PubMed Central

    Bellan, Steven E.; Pulliam, Juliet R. C.; Pearson, Carl A. B.; Champredon, David; Fox, Spencer J.; Skrip, Laura; Galvani, Alison P.; Gambhir, Manoj; Lopman, Ben A.; Porco, Travis C.; Meyers, Lauren Ancel; Dushoff, Jonathan

    2016-01-01

    Background Safe and effective vaccines may help end the ongoing Ebola virus disease (EVD) epidemic in West Africa, and mitigate future outbreaks. We evaluate the statistical validity and power of randomized controlled (RCT) and stepped-wedge cluster trial (SWCT) designs in Sierra Leone, where EVD incidence is spatiotemporally heterogeneous, and rapidly declining. Methods We forecasted district-level EVD incidence over the next six months using a stochastic model fit to data from Sierra Leone. We then simulated RCT and SWCT designs in trial populations comprising geographically distinct clusters of high risk, taking into account realistic logistical constraints, as well as both individual-level and cluster-level variation in risk. We assessed false positive rates and power for parametric and nonparametric analyses of simulated trial data, across a range of vaccine efficacies and trial start dates. Findings For an SWCT, regional variation in EVD incidence trends produced inflated false positive rates (up to 0.11 at α=0.05) under standard statistical models, but not when analyzed by a permutation test, whereas all analyses of RCTs remained valid. Assuming a six-month trial starting February 18, 2015, we estimate the power to detect a 90% efficacious vaccine to be between 48% and 89% for an RCT, and between 6.4% and 26% for an SWCT, depending on incidence within the trial population. We estimate that a one-month delay in implementation will reduce the power of the RCT and SWCT by 20% and 49%, respectively. Interpretation Spatiotemporal variation in infection risk undermines the SWCT's statistical power. This variation also undercuts the SWCT's expected ethical advantages over the RCT, because the latter but not the former can prioritize high-risk clusters. Funding US National Institutes of Health, US National Science Foundation, Canadian Institutes of Health Research PMID:25886798

  9. 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…

  10. 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…

  11. Dichotomizing a continuous outcome in cluster randomized trials: impact on power.

    PubMed

    Caille, Agnès; Leyrat, Clémence; Giraudeau, Bruno

    2012-10-30

    In cluster randomized trials (CRTs), clusters of individuals are randomized rather than the individuals themselves. For such trials, power depends in part on the degree of similarity among responses within a cluster, which is quantified by the intaclass correlation coefficient (ICC). Thus, for a fixed sample size, power decreases with increasing ICC. In reliability studies with two observers, dichotomizing a continuous outcome variable has been shown to reduce the ICC. We checked (by a simulation study) that this property still applies to CRTs, in which cluster sizes are variable and usually greater than in reliability studies and observations (within clusters) are exchangeable. Then, in a CRT, dichotomizing a continuous outcome actually induces two antagonistic effects: decreased power because of loss of information and increased power induced by attenuation of the ICC. Therefore, we aimed to assess the impact of dichotomizing a continuous outcome on power in a CRT. We derived an analytical formula for power based on a generalized estimating equation approach after dichotomizing a continuous outcome. This theoretical result was obtained by considering equal cluster sizes, and we then assessed its accuracy (by a simulation study) in the more realistic situation of varying cluster sizes. We showed that dichotomization is associated with decreased power: attenuation of the ICC does not compensate for the loss of power induced by loss of information. Loss of power is reduced with increased initial continuous-outcome ICC and/or prevalence of success for the dichotomized outcome approaching 50%. PMID:22733454

  12. 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

  13. Trial application of reliability technology to emergency diesel generators at the Trojan Nuclear Power Plant

    SciTech Connect

    Wong, S.M.; Boccio, J.L.; Karimian, S.; Azarm, M.A.; Carbonaro, J.; DeMoss, G.

    1986-01-01

    In this paper, a trial application of reliability technology to the emergency diesel generator system at the Trojan Nuclear Power Plant is presented. An approach for formulating a reliability program plan for this system is being developed. The trial application has shown that a reliability program process, using risk- and reliability-based techniques, can be interwoven into current plant operational activities to help in controlling, analyzing, and predicting faults that can challenge safety systems. With the cooperation of the utility, Portland General Electric Co., this reliability program can eventually be implemented at Trojan to track its effectiveness.

  14. The Effect of Cluster Size Variability on Statistical Power in Cluster-Randomized Trials

    PubMed Central

    Lauer, Stephen A.; Kleinman, Ken P.; Reich, Nicholas G.

    2015-01-01

    The frequency of cluster-randomized trials (CRTs) in peer-reviewed literature has increased exponentially over the past two decades. CRTs are a valuable tool for studying interventions that cannot be effectively implemented or randomized at the individual level. However, some aspects of the design and analysis of data from CRTs are more complex than those for individually randomized controlled trials. One of the key components to designing a successful CRT is calculating the proper sample size (i.e. number of clusters) needed to attain an acceptable level of statistical power. In order to do this, a researcher must make assumptions about the value of several variables, including a fixed mean cluster size. In practice, cluster size can often vary dramatically. Few studies account for the effect of cluster size variation when assessing the statistical power for a given trial. We conducted a simulation study to investigate how the statistical power of CRTs changes with variable cluster sizes. In general, we observed that increases in cluster size variability lead to a decrease in power. PMID:25830416

  15. Statistical power of multilevel modelling in dental caries clinical trials: a simulation study.

    PubMed

    Burnside, G; Pine, C M; Williamson, P R

    2014-01-01

    Outcome data from dental caries clinical trials have a naturally hierarchical structure, with surfaces clustered within teeth, clustered within individuals. Data are often aggregated into the DMF index for each individual, losing tooth- and surface-specific information. If these data are to be analysed by tooth or surface, allowing exploration of effects of interventions on different teeth and surfaces, appropriate methods must be used to adjust for the clustered nature of the data. Multilevel modelling allows analysis of clustered data using individual observations without aggregating data, and has been little used in the field of dental caries. A simulation study was conducted to investigate the performance of multilevel modelling methods and standard caries increment analysis. Data sets were simulated from a three-level binomial distribution based on analysis of a caries clinical trial in Scottish adolescents, with varying sample sizes, treatment effects and random tooth level effects based on trials reported in Cochrane reviews of topical fluoride, and analysed to compare the power of multilevel models and traditional analysis. 40,500 data sets were simulated. Analysis showed that estimated power for the traditional caries increment method was similar to that for multilevel modelling, with more variation in smaller data sets. Multilevel modelling may not allow significant reductions in the number of participants required in a caries clinical trial, compared to the use of traditional analyses, but investigators interested in exploring the effect of their intervention in more detail may wish to consider the application of multilevel modelling to their clinical trial data. PMID:24216573

  16. 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 to support the reasonable belief that a particular...

  17. 29 CFR 98.900 - Adequate evidence.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 1 2010-07-01 2010-07-01 true Adequate evidence. 98.900 Section 98.900 Labor Office of the Secretary of Labor GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) Definitions § 98.900 Adequate evidence. Adequate evidence means information sufficient to support the reasonable belief that a...

  18. Power/sample size calculations for assessing correlates of risk in clinical efficacy trials.

    PubMed

    Gilbert, Peter B; Janes, Holly E; Huang, Yunda

    2016-09-20

    In a randomized controlled clinical trial that assesses treatment efficacy, a common objective is to assess the association of a measured biomarker response endpoint with the primary study endpoint in the active treatment group, using a case-cohort, case-control, or two-phase sampling design. Methods for power and sample size calculations for such biomarker association analyses typically do not account for the level of treatment efficacy, precluding interpretation of the biomarker association results in terms of biomarker effect modification of treatment efficacy, with detriment that the power calculations may tacitly and inadvertently assume that the treatment harms some study participants. We develop power and sample size methods accounting for this issue, and the methods also account for inter-individual variability of the biomarker that is not biologically relevant (e.g., due to technical measurement error). We focus on a binary study endpoint and on a biomarker subject to measurement error that is normally distributed or categorical with two or three levels. We illustrate the methods with preventive HIV vaccine efficacy trials and include an R package implementing the methods. Copyright © 2016 John Wiley & Sons, Ltd. PMID:27037797

  19. 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…

  20. 34 CFR 85.900 - Adequate evidence.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) Definitions § 85.900 Adequate evidence. Adequate evidence means information sufficient to support the reasonable belief that a particular act or omission has occurred. Authority: E.O. 12549 (3 CFR, 1986 Comp., p. 189); E.O 12689 (3 CFR, 1989 Comp., p. 235); 20 U.S.C. 1082, 1094, 1221e-3 and 3474; and Sec....

  1. 29 CFR 452.110 - Adequate safeguards.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 2 2010-07-01 2010-07-01 false Adequate safeguards. 452.110 Section 452.110 Labor... DISCLOSURE ACT OF 1959 Election Procedures; Rights of Members § 452.110 Adequate safeguards. (a) In addition to the election safeguards discussed in this part, the Act contains a general mandate in section...

  2. 29 CFR 452.110 - Adequate safeguards.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 2 2011-07-01 2011-07-01 false Adequate safeguards. 452.110 Section 452.110 Labor... DISCLOSURE ACT OF 1959 Election Procedures; Rights of Members § 452.110 Adequate safeguards. (a) In addition to the election safeguards discussed in this part, the Act contains a general mandate in section...

  3. Effects of magnitude and frequency of variations in external power output on simulated cycling time-trial performance.

    PubMed

    Wells, Marc; Atkinson, Greg; Marwood, Simon

    2013-01-01

    Mechanical models of cycling time-trial performance have indicated adverse effects of variations in external power output on overall performance times. Nevertheless, the precise influences of the magnitude and number of these variations over different distances of time trial are unclear. 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 times were modelled over distances of 4-40 km, mean power outputs of 200-600 W, power variation amplitudes of 5-15% and variation frequencies of 2-32 per time-trial. Effects of a "fast-start" strategy were compared with those of a constant-power strategy. Varying power improved 4-km performance at all power outputs, with the greatest improvement being 0.90 s for ± 15% power variation. For distances of 16.1, 20 and 40 km, varying power by ± 15% increased times by 3.29, 4.46 and 10.43 s respectively, suggesting that in long-duration cycling in constant environmental conditions, cyclists should strive to reduce power variation to maximise performance. The novel finding of the present study is that these effects are augmented with increasing event distance, amplitude and period of variation. These two latter factors reflect a poor adherence to a constant speed. PMID:23711074

  4. Americans Getting Adequate Water Daily, CDC Finds

    MedlinePlus

    ... medlineplus/news/fullstory_158510.html Americans Getting Adequate Water Daily, CDC Finds Men take in an average ... new government report finds most are getting enough water each day. The data, from the U.S. National ...

  5. Americans Getting Adequate Water Daily, CDC Finds

    MedlinePlus

    ... gov/news/fullstory_158510.html Americans Getting Adequate Water Daily, CDC Finds Men take in an average ... new government report finds most are getting enough water each day. The data, from the U.S. National ...

  6. 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

  7. 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

  8. 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.

  9. Adequate supervision for children and adolescents.

    PubMed

    Anderst, James; Moffatt, Mary

    2014-11-01

    Primary care providers (PCPs) have the opportunity to improve child health and well-being by addressing supervision issues before an injury or exposure has occurred and/or after an injury or exposure has occurred. Appropriate anticipatory guidance on supervision at well-child visits can improve supervision of children, and may prevent future harm. Adequate supervision varies based on the child's development and maturity, and the risks in the child's environment. Consideration should be given to issues as wide ranging as swimming pools, falls, dating violence, and social media. By considering the likelihood of harm and the severity of the potential harm, caregivers may provide adequate supervision by minimizing risks to the child while still allowing the child to take "small" risks as needed for healthy development. Caregivers should initially focus on direct (visual, auditory, and proximity) supervision of the young child. Gradually, supervision needs to be adjusted as the child develops, emphasizing a safe environment and safe social interactions, with graduated independence. PCPs may foster adequate supervision by providing concrete guidance to caregivers. In addition to preventing injury, supervision includes fostering a safe, stable, and nurturing relationship with every child. PCPs should be familiar with age/developmentally based supervision risks, adequate supervision based on those risks, characteristics of neglectful supervision based on age/development, and ways to encourage appropriate supervision throughout childhood. PMID:25369578

  10. Small Rural Schools CAN Have Adequate Curriculums.

    ERIC Educational Resources Information Center

    Loustaunau, Martha

    The small rural school's foremost and largest problem is providing an adequate curriculum for students in a changing world. Often the small district cannot or is not willing to pay the per-pupil cost of curriculum specialists, specialized courses using expensive equipment no more than one period a day, and remodeled rooms to accommodate new…

  11. 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…

  12. Inspiratory muscle training improves cycling time-trial performance and anaerobic work capacity but not critical power.

    PubMed

    Johnson, Michael A; Sharpe, Graham R; Brown, Peter I

    2007-12-01

    We examined whether inspiratory muscle training (IMT) improved cycling time-trial performance and changed the relationship between limit work (W (lim)) and limit time (T (lim)), which is described by the parameters critical power (CP) and anaerobic work capacity (AWC). Eighteen male cyclists were assigned to either a pressure-threshold IMT or sham hypoxic-training placebo (PLC) group. Prior to and following a 6 week intervention subjects completed a 25-km cycling time-trial and three constant-power tests to establish the W (lim)-T (lim) relationship. Constant-power tests were prescribed to elicit exercise intolerance within 3-10 (Ex1), 10-20 (Ex2), and 20-30 (Ex3) min. Maximal inspiratory mouth pressure increased by (mean +/- SD) 17.1 +/- 12.2% following IMT (P < 0.01) and was accompanied by a 2.66 +/- 2.51% improvement in 25-km time-trial performance (P < 0.05); there were no changes following PLC. Constant-power cycling endurance was unchanged following PLC, as was CP (pre vs. post: 249 +/- 32 vs. 250 +/- 32 W) and AWC (30.7 +/- 12.7 vs. 30.1 +/- 12.5 kJ). Following IMT Ex1 and Ex3 cycling endurance improved by 18.3 +/- 15.1 and 15.3 +/- 19.1% (P < 0.05), respectively, CP was unchanged (264 +/- 62 vs. 263 +/- 61 W), but AWC increased from 24.8 +/- 5.6 to 29.0 +/- 8.4 kJ (P < 0.05). In conclusion, these data provide novel evidence that improvements in constant-power and cycling time-trial performance following IMT in cyclists may be explained, in part, by an increase in AWC. PMID:17874123

  13. 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),…

  14. Adequation of mini satellites to oceanic altimetry missions

    NASA Astrophysics Data System (ADS)

    Bellaieche, G.; Aguttes, J. P.

    1993-01-01

    Association of the mini satellite concept and oceanic altimetry missions is discussed. Mission definition and most constraining requirements (mesoscale for example) demonstrate mini satellites to be quite adequate for such missions. Progress in altimeter characteristics, orbit determination, and position reporting allow consideration of oceanic altimetry missions using low Earth orbit satellites. Satellite constellation, trace keeping and orbital period, and required payload characteristics are exposed. The mission requirements covering Sun synchronous orbit, service area, ground system, and launcher characteristics as well as constellation maintenance strategy are specified. Two options for the satellite, orbital mechanics, propulsion, onboard power and stabilizing subsystems, onboard management, satellite ground linkings, mechanical and thermal subsystems, budgets, and planning are discussed.

  15. Power and sample size determination when assessing the clinical relevance of trial results by 'responder analyses'.

    PubMed

    Kieser, Meinhard; Röhmel, Joachim; Friede, Tim

    2004-11-15

    A fundamental issue in regulatory decision making is the assessment of the benefit/risk profile of a compound. In order to do this, establishing the existence of a treatment effect by a significance test is not sufficient, but the clinical relevance of a potential benefit must also be taken into account. A number of regulatory guidelines propose that clinical relevance should be assessed by considering the rate of responders, i.e. the proportion of patients who are observed to achieve an apparently meaningful benefit. In this paper, we present methods for planning clinical trials that aim at demonstrating both statistical and clinical significance in superiority trials. Procedures based on analytical calculations are derived for normally distributed data and the case of a single endpoint as well as multiple primary outcomes. A bootstrap procedure is proposed that can be applied to non-normal data. Application is illustrated by a clinical trial in Alzheimer's disease. PMID:15490433

  16. Sample Size Calculation: Inaccurate A Priori Assumptions for Nuisance Parameters Can Greatly Affect the Power of a Randomized Controlled Trial

    PubMed Central

    Tavernier, Elsa; Giraudeau, Bruno

    2015-01-01

    We aimed to examine the extent to which inaccurate assumptions for nuisance parameters used to calculate sample size can affect the power of a randomized controlled trial (RCT). In a simulation study, we separately considered an RCT with continuous, dichotomous or time-to-event outcomes, with associated nuisance parameters of standard deviation, success rate in the control group and survival rate in the control group at some time point, respectively. For each type of outcome, we calculated a required sample size N for a hypothesized treatment effect, an assumed nuisance parameter and a nominal power of 80%. We then assumed a nuisance parameter associated with a relative error at the design stage. For each type of outcome, we randomly drew 10,000 relative errors of the associated nuisance parameter (from empirical distributions derived from a previously published review). Then, retro-fitting the sample size formula, we derived, for the pre-calculated sample size N, the real power of the RCT, taking into account the relative error for the nuisance parameter. In total, 23%, 0% and 18% of RCTs with continuous, binary and time-to-event outcomes, respectively, were underpowered (i.e., the real power was < 60%, as compared with the 80% nominal power); 41%, 16% and 6%, respectively, were overpowered (i.e., with real power > 90%). Even with proper calculation of sample size, a substantial number of trials are underpowered or overpowered because of imprecise knowledge of nuisance parameters. Such findings raise questions about how sample size for RCTs should be determined. PMID:26173007

  17. Is a vegetarian diet adequate for children.

    PubMed

    Hackett, A; Nathan, I; Burgess, L

    1998-01-01

    The number of people who avoid eating meat is growing, especially among young people. Benefits to health from a vegetarian diet have been reported in adults but it is not clear to what extent these benefits are due to diet or to other aspects of lifestyles. In children concern has been expressed concerning the adequacy of vegetarian diets especially with regard to growth. The risks/benefits seem to be related to the degree of restriction of he diet; anaemia is probably both the main and the most serious risk but this also applies to omnivores. Vegan diets are more likely to be associated with malnutrition, especially if the diets are the result of authoritarian dogma. Overall, lacto-ovo-vegetarian children consume diets closer to recommendations than omnivores and their pre-pubertal growth is at least as good. The simplest strategy when becoming vegetarian may involve reliance on vegetarian convenience foods which are not necessarily superior in nutritional composition. The vegetarian sector of the food industry could do more to produce foods closer to recommendations. Vegetarian diets can be, but are not necessarily, adequate for children, providing vigilance is maintained, particularly to ensure variety. Identical comments apply to omnivorous diets. Three threats to the diet of children are too much reliance on convenience foods, lack of variety and lack of exercise. PMID:9670174

  18. LOWER EXTREMITY PEAK POWER TRAINING IN ELDERLY SUBJECTS WITH MODERATE MOBILITY LIMITATIONS: A RANDOMIZED CONTROLLED TRIAL

    Technology Transfer Automated Retrieval System (TEKTRAN)

    To examine the effects of a lower extremity high-velocity high-power exercise training intervention in older adults with moderate mobility impairments, and to investigate whether peak power training results in greater increases of peak muscle power output compared to traditional progressive resistan...

  19. 21 CFR 314.126 - Adequate and well-controlled studies.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... conducting clinical investigations of a drug is to distinguish the effect of a drug from other influences... recognized by the scientific community as the essentials of an adequate and well-controlled clinical... randomization and blinding of patients or investigators, or both. If the intent of the trial is to...

  20. Optimal power-to-mass ratios when predicting flat and hill-climbing time-trial cycling.

    PubMed

    Nevill, A M; Jobson, S A; Davison, R C R; Jeukendrup, A E

    2006-07-01

    The purpose of this article was to establish whether previously reported oxygen-to-mass ratios, used to predict flat and hill-climbing cycling performance, extend to similar power-to-mass ratios incorporating other, often quick and convenient measures of power output recorded in the laboratory [maximum aerobic power (W(MAP)), power output at ventilatory threshold (W(VT)) and average power output (W(AVG)) maintained during a 1 h performance test]. A proportional allometric model was used to predict the optimal power-to-mass ratios associated with cycling speeds during flat and hill-climbing cycling. The optimal models predicting flat time-trial cycling speeds were found to be (W(MAP)m(-0.48))(0.54), (W(VT)m(-0.48))(0.46) and (W(AVG)m(-0.34))(0.58) that explained 69.3, 59.1 and 96.3% of the variance in cycling speeds, respectively. Cross-validation results suggest that, in conjunction with body mass, W(MAP) can provide an accurate and independent prediction of time-trial cycling, explaining 94.6% of the variance in cycling speeds with the standard deviation about the regression line, s=0.686 km h(-1). Based on these models, there is evidence to support that previously reported VO2-to-mass ratios associated with flat cycling speed extend to other laboratory-recorded measures of power output (i.e. Wm(-0.32)). However, the power-function exponents (0.54, 0.46 and 0.58) would appear to conflict with the assumption that the cyclists' speeds should be proportional to the cube root (0.33) of power demand/expended, a finding that could be explained by other confounding variables such as bicycle geometry, tractional resistance and/or the presence of a tailwind. The models predicting 6 and 12% hill-climbing cycling speeds were found to be proportional to (W(MAP)m(-0.91))(0.66), revealing a mass exponent, 0.91, that also supports previous research. PMID:16685550

  1. 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...

  2. Power of univariate and multivariate analyses of repeated measurements in controlled clinical trials.

    PubMed

    Overall, J E; Atlas, R S

    1999-04-01

    The power of univariate and multivariate tests of significance is compared in relation to linear and nonlinear patterns of treatment effects in a repeated measurement design. Bonferroni correction was used to control the experiment-wise error rate in combining results from univariate tests of significance accomplished separately on average level, linear, quadratic, and cubic trend components. Multivariate tests on these same components of the overall treatment effect, as well as a multivariate test for between-groups difference on the original repeated measurements, were also evaluated for power against the same representative patterns of treatment effects. Results emphasize the advantage of parsimony that is achieved by transforming multiple repeated measurements into a reduced set of mean ngful composite variables representing average levels and rates of change. The Bonferroni correction applied to the separate univariate tests provided experiment-wise protection against Type I error, produced slightly greater experiment-wise power than a multivariate test applied to the same components of the data patterns, and provided substantially greater power than a multivariate test on the complete set of original repeated measurements. The separate univariate tests provide interpretive advantage regarding locus of the treatment effects. PMID:10348408

  3. 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...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drugs; adequate directions for use. 201.5 Section...) DRUGS: GENERAL LABELING General Labeling Provisions § 201.5 Drugs; adequate directions for use. Adequate directions for use means directions under which the layman can use a drug safely and for the purposes...

  5. 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...) DRUGS: GENERAL LABELING General Labeling Provisions § 201.5 Drugs; adequate directions for use. Adequate directions for use means directions under which the layman can use a drug safely and for the purposes...

  6. 4 CFR 200.14 - Responsibility for maintaining adequate safeguards.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 4 Accounts 1 2010-01-01 2010-01-01 false Responsibility for maintaining adequate safeguards. 200.14 Section 200.14 Accounts RECOVERY ACCOUNTABILITY AND TRANSPARENCY BOARD PRIVACY ACT OF 1974 § 200.14 Responsibility for maintaining adequate safeguards. The Board has the responsibility for maintaining adequate technical, physical, and...

  7. 10 CFR 1304.114 - Responsibility for maintaining adequate safeguards.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Responsibility for maintaining adequate safeguards. 1304.114 Section 1304.114 Energy NUCLEAR WASTE TECHNICAL REVIEW BOARD PRIVACY ACT OF 1974 § 1304.114 Responsibility for maintaining adequate safeguards. The Board has the responsibility for maintaining adequate technical, physical, and security...

  8. 10 CFR 1304.114 - Responsibility for maintaining adequate safeguards.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 4 2012-01-01 2012-01-01 false Responsibility for maintaining adequate safeguards. 1304.114 Section 1304.114 Energy NUCLEAR WASTE TECHNICAL REVIEW BOARD PRIVACY ACT OF 1974 § 1304.114 Responsibility for maintaining adequate safeguards. The Board has the responsibility for maintaining adequate technical, physical, and security...

  9. 4 CFR 200.14 - Responsibility for maintaining adequate safeguards.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 4 Accounts 1 2011-01-01 2011-01-01 false Responsibility for maintaining adequate safeguards. 200....14 Responsibility for maintaining adequate safeguards. The Board has the responsibility for maintaining adequate technical, physical, and security safeguards to prevent unauthorized disclosure...

  10. A double blind randomised trial of low power laser treatment in rheumatoid arthritis.

    PubMed Central

    Heussler, J K; Hinchey, G; Margiotta, E; Quinn, R; Butler, P; Martin, J; Sturgess, A D

    1993-01-01

    OBJECTIVES--To define the value of low power laser treatment in small joint rheumatoid arthritis. METHODS--Twenty five women with active disease were recruited. The metacarpophalangeal and proximal interphalangeal joints of one hand were treated with 12 J/cm2 for 30 s with a gallium-aluminium-arsenate laser. The other hand received a sham laser treatment designed so that neither therapist nor patient could distinguish the active laser from the sham laser. Each patient received 12 treatments over four weeks. The following parameters were measured: pain as assessed by visual analogue scale; range of joint movements; grip strength; duration of early morning stiffness, joint circumference, Jebsen's hand assessment; drug usage; total swollen joint counts; Arthritis Impact Measurement Scales; three phase bone scans; haematological and serological tests. RESULTS--A total of 72% of patients reported pain relief but this reduction was reported equally in both hands. No significant changes were seen in other clinical, functional, scintigraphic, or laboratory features. Neither patients nor staff were able to detect which hand was treated with the active laser. CONCLUSION--When this specific laser and dose regimen was used, low power laser treatment had no objective effect on patients with rheumatoid arthritis. It did appear to produce analgesia through a powerful placebo effect. PMID:8257205

  11. Effect of Lifestyle Intervention on Cardiometabolic Risk Factors: Results of the POWER-UP Trial

    PubMed Central

    Vetter, Marion L.; Wadden, Thomas A.; Chittams, Jesse; Diewald, Lisa; Panigrahi, Eva; Volger, Sheri; Sarwer, David B.; Moore, Reneé H.

    2013-01-01

    Objective To investigate the effects of three weight loss interventions on cardiometabolic risk factors including blood pressure, lipids, glucose, and markers of insulin resistance and inflammation. We also examined whether categories of incremental weight change conferred greater improvements on these parameters. Methods This 2-year trial was conducted in a primary care setting and included 390 obese participants who were randomly assigned to one of three interventions: 1) Usual Care [quarterly primary care provider (PCP) visits that included education about weight management]; 2) Brief Lifestyle Counseling (quarterly PCP visits plus monthly behavioral counseling provided by a trained auxiliary healthcare provider); or 3) Enhanced Brief Lifestyle Counseling (the same care as described for the previous intervention, plus weight loss medications or meal replacements). The primary outcome was change in cardiometabolic risk factors among groups. Results At month 24, participants in Enhanced Brief Lifestyle Counseling lost significantly more weight than those in Usual Care (4.6 vs. 1.7 kg), with no other significant differences between groups. Enhanced Brief Lifestyle Counseling produced significantly greater improvements in HDL cholesterol and triglyceride levels at one or more assessments, compared with the other two interventions. Markers of insulin resistance also improved significantly more in this group throughout the 2 years. Collapsing across the three groups, greater weight loss was associated with greater improvements in triglycerides, HDL cholesterol, and markers of insulin resistance and inflammation at month 24, but was not significantly associated with reductions in blood pressure, total cholesterol, and LDL cholesterol at any time. Conclusions Enhanced Brief Lifestyle Counseling, which produced the largest weight loss, was generally associated with the greatest improvements in cardiovascular risk factors. These findings suggest that an intensive weight

  12. Haemodynamic Optimization by Oesophageal Doppler and Pulse Power Wave Analysis in Liver Surgery: A Randomised Controlled Trial

    PubMed Central

    Feldheiser, Aarne; Pavlova, Velizara; Weimann, Karin; Hunsicker, Oliver; Stockmann, Martin; Koch, Mandy; Giebels, Alexander; Wernecke, Klaus-Dieter; Spies, Claudia D.

    2015-01-01

    Liver surgery is still associated with a high rate of morbidity and mortality. We aimed to compare different haemodynamic treatments in liver surgery. In a prospective, blinded, randomised, controlled pilot trial patients undergoing liver resection were randomised to receive haemodynamic management guided by conventional haemodynamic parameters or by oesophageal Doppler monitor (ODM, CardioQ-ODM) or by pulse power wave analysis (PPA, LiDCOrapid) within a goal-directed algorithm adapted for liver surgery. The primary endpoint was stroke volume index before intra-operative start of liver resection. Secondary endpoints were the haemodynamic course during surgery and postoperative pain levels. Due to an unbalance in the extension of the surgical procedures with a high rate of only minor procedures the conventional group was dropped from the analysis. Eleven patients in the ODM group and 10 patients in the PPA group were eligible for statistical analysis. Stroke volume index before start of liver resection was 49 (37; 53) ml/m2 and 48 (41; 56) ml/m2 in the ODM and PPA group, respectively (p=0.397). The ODM guided group was haemodynamically stable as shown by ODM and PPA measurements. However, the PPA guided group showed a significant increase of pulse-pressure-variability (p=0.002) that was not accompanied by a decline of stroke volume index displayed by the PPA (p=0.556) but indicated by a decline of stroke volume index by the ODM (p<0.001). The PPA group had significantly higher postoperative pain levels than the ODM group (p=0.036). In conclusion, goal-directed optimization by ODM and PPA showed differences in intraoperative cardiovascular parameters indicating that haemodynamic optimization is not consistent between the two monitors. Trial Registration ISRCTN.com ISRCTN64578872 PMID:26186702

  13. Treatment of asthma exacerbations with the human-powered nebuliser: a randomised parallel-group clinical trial

    PubMed Central

    Hallberg, Christopher J; Lysaught, M Therese; Najarro, René Antonio; Cea Gil, Fausto; Villatoro, Clara; Diaz de Uriarte, Ana Celia; Olson, Lars E

    2014-01-01

    Background: Nebulisers aid the treatment of respiratory diseases, including asthma, but they require electricity and are often cost-prohibitive for low- and middle-income countries. Aims: The aim of this study was to compare a low-cost, human-powered nebuliser compressor with an electric nebuliser compressor for the treatment of mild to moderate asthma exacerbations in adults and children. Methods: This was a non-blinded, parallel-group, equivalence study, with 110 subjects between 6 and 65 years of age, conducted in the emergency department of a district hospital in Ilopango, El Salvador. Participants were assigned by random allocation to receive a 2.5-mg dose of salbutamol from the experimental human-powered nebuliser or the electric nebuliser control. All assigned participants completed treatment and were included in analysis. The study was not blinded as this was clinically unfeasible; however, data analysis was blinded. Results: The mean improvement in peak flow of the experimental and control groups was 37.5 (95% confidence interval (CI) 26.7–48.2) l/min and 38.7 (95% CI, 26.1–51.3) l/min, respectively, with a mean difference of 1.3 (95% CI, −15.1 to 17.7) l/min. The mean improvement in percent-expected peak flow for the experimental and control groups was 12.3% (95% CI, 9.1–15.5%) and 13.8% (95% CI, 9.8–17.9%), respectively, with a mean difference of 1.5% (95% CI, −3.6 to 6.6%). Conclusions: The human-powered nebuliser compressor is equivalent to a standard nebuliser compressor for the treatment of mild-to-moderate asthma. (Funded by the Opus Dean’s Fund, Marquette University College of Engineering; ClinicalTrials.gov NCT01795742.) PMID:24965834

  14. Design of the Value of Imaging in Enhancing the Wellness of Your Heart (VIEW) Trial and the Impact of Uncertainty on Power

    PubMed Central

    Ambrosius, Walter T.; Polonsky, Tamar S.; Greenland, Philip; Goff, David C.; Perdue, Letitia H.; Fortmann, Stephen P.; Margolis, Karen L.; Pajewski, Nicholas M.

    2014-01-01

    Background Although observational evidence has suggested that the measurement of CAC may improve risk stratification for cardiovascular events and thus help guide the use of lipid-lowering therapy, this contention has not been evaluated within the context of a randomized trial. The Value of Imaging in Enhancing the Wellness of Your Heart (VIEW) trial is proposed as a randomized study in participants at low intermediate risk of future coronary heart disease (CHD) events to evaluate whether coronary artery calcium (CAC) testing leads to improved patient outcomes. Purpose To describe the challenges encountered in designing a prototypical screening trial and to examine the impact of uncertainty on power. Methods The VIEW trial was designed as an effectiveness clinical trial to examine the benefit of CAC testing to guide therapy on a primary outcome consisting of a composite of non-fatal myocardial infarction, probable or definite angina with revascularization, resuscitated cardiac arrest, non-fatal stroke (not transient ischemic attack (TIA)), CHD death, stroke death, other atherosclerotic death, or other cardiovascular disease (CVD) death. Many critical choices were faced in designing the trial, including: (1) the choice of primary outcome, (2) the choice of therapy, (3) the target population with corresponding ethical issues, (4) specifications of assumptions for sample size calculations, and (5) impact of uncertainty in these assumptions on power/sample size determination. Results We have proposed a sample size of 30,000 (800 events) which provides 92.7% power. Alternatively, sample sizes of 20,228 (539 events), 23,138 (617 events) and 27,078 (722 events) provide 80, 85, and 90% power. We have also allowed for uncertainty in our assumptions by computing average power integrated over specified prior distributions. This relaxation of specificity indicates a reduction in power, dropping to 89.9% (95% confidence interval (CI): 89.8 to 89.9) for a sample size of 30

  15. A Multicenter Randomized Controlled Trial Comparing Treatment of Venous Leg Ulcers Using Mechanically Versus Electrically Powered Negative Pressure Wound Therapy

    PubMed Central

    Marston, William A.; Armstrong, David G.; Reyzelman, Alexander M.; Kirsner, Robert S.

    2015-01-01

    Objective: This study compares two different negative pressure wound therapy (NPWT) modalities in the treatment of venous leg ulcers (VLUs), the ultraportable mechanically powered (MP) Smart Negative Pressure (SNaP®) Wound Care System to the electrically powered (EP) Vacuum-Assisted Closure (V.A.C.®) System. Approach: Patients with VLUs from 13 centers participated in this prospective randomized controlled trial. Each subject was randomly assigned to treatment with either MP NPWT or EP NPWT and evaluated for 16 weeks or complete wound closure. Results: Forty patients (n=19 MP NPWT and n=21 EP NPWT) completed the study. Primary endpoint analysis of wound size reduction found wounds in the MP NPWT group had significantly greater wound size reduction than those in the EP NPWT group at 4, 8, 12, and 16 weeks (p-value=0.0039, 0.0086, 0.0002, and 0.0005, respectively). Kaplan–Meier analyses showed greater acceleration in complete wound closure in the MP NPWT group. At 30 days, 50% wound closure was achieved in 52.6% (10/19) of patients treated with MP NPWT and 23.8% (5/21) of patients treated with EP NPWT. At 90 days, complete wound closure was achieved in 57.9% (11/19) of patients treated with MP NPWT and 38.15% (8/21) of patients treated with EP NPWT. Innovation: These data support the use of MP-NPWT for the treatment of VLUs. Conclusions: In this group of venous ulcers, wounds treated with MP NPWT demonstrated greater improvement and a higher likelihood of complete wound closure than those treated with EP NPWT. PMID:25713749

  16. 7 CFR 4290.200 - Adequate capital for RBICs.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 15 2011-01-01 2011-01-01 false Adequate capital for RBICs. 4290.200 Section 4290.200 Agriculture Regulations of the Department of Agriculture (Continued) RURAL BUSINESS-COOPERATIVE SERVICE AND... Qualifications for the RBIC Program Capitalizing A Rbic § 4290.200 Adequate capital for RBICs. You must meet...

  17. 13 CFR 107.200 - Adequate capital for Licensees.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 13 Business Credit and Assistance 1 2011-01-01 2011-01-01 false Adequate capital for Licensees... INVESTMENT COMPANIES Qualifying for an SBIC License Capitalizing An Sbic § 107.200 Adequate capital for... Licensee, and to receive Leverage. (a) You must have enough Regulatory Capital to provide...

  18. 13 CFR 107.200 - Adequate capital for Licensees.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Adequate capital for Licensees... INVESTMENT COMPANIES Qualifying for an SBIC License Capitalizing An Sbic § 107.200 Adequate capital for... Licensee, and to receive Leverage. (a) You must have enough Regulatory Capital to provide...

  19. 7 CFR 4290.200 - Adequate capital for RBICs.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 15 2010-01-01 2010-01-01 false Adequate capital for RBICs. 4290.200 Section 4290.200 Agriculture Regulations of the Department of Agriculture (Continued) RURAL BUSINESS-COOPERATIVE SERVICE AND... Qualifications for the RBIC Program Capitalizing A Rbic § 4290.200 Adequate capital for RBICs. You must meet...

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

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false Responsibility for maintaining adequate safeguards. 1304.114 Section 1304.114 Energy NUCLEAR WASTE TECHNICAL REVIEW BOARD PRIVACY ACT OF 1974 § 1304.114 Responsibility for maintaining adequate safeguards. The Board has the responsibility for maintaining...

  1. 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 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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... 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...

  7. 40 CFR 716.25 - Adequate file search.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 32 2013-07-01 2013-07-01 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...

  8. 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... 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...

  9. 40 CFR 716.25 - Adequate file search.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 32 2012-07-01 2012-07-01 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...

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

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 4 2014-01-01 2014-01-01 false Responsibility for maintaining adequate safeguards. 1304.114 Section 1304.114 Energy NUCLEAR WASTE TECHNICAL REVIEW BOARD PRIVACY ACT OF 1974 § 1304.114 Responsibility for maintaining adequate safeguards. The Board has the responsibility for maintaining...

  11. 10 CFR 1304.114 - Responsibility for maintaining adequate safeguards.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Responsibility for maintaining adequate safeguards. 1304.114 Section 1304.114 Energy NUCLEAR WASTE TECHNICAL REVIEW BOARD PRIVACY ACT OF 1974 § 1304.114 Responsibility for maintaining adequate safeguards. The Board has the responsibility for maintaining...

  12. 10 CFR 503.35 - Inability to obtain adequate capital.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Inability to obtain adequate capital. 503.35 Section 503.35 Energy DEPARTMENT OF ENERGY (CONTINUED) ALTERNATE FUELS NEW FACILITIES Permanent Exemptions for New Facilities § 503.35 Inability to obtain adequate capital. (a) Eligibility. Section 212(a)(1)(D)...

  13. 10 CFR 503.35 - Inability to obtain adequate capital.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false Inability to obtain adequate capital. 503.35 Section 503.35 Energy DEPARTMENT OF ENERGY (CONTINUED) ALTERNATE FUELS NEW FACILITIES Permanent Exemptions for New Facilities § 503.35 Inability to obtain adequate capital. (a) Eligibility. Section 212(a)(1)(D)...

  14. 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 find... 15 Commerce and Foreign Trade 3 2011-01-01 2011-01-01 false Adequate exploration plan....

  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 find... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Adequate exploration plan....

  16. "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…

  17. Trials within trials? Researcher, funder and ethical perspectives on the practicality and acceptability of nesting trials of recruitment methods in existing primary care trials

    PubMed Central

    2010-01-01

    Background Trials frequently encounter difficulties in recruitment, but evidence on effective recruitment methods in primary care is sparse. A robust test of recruitment methods involves comparing alternative methods using a randomized trial, 'nested' in an ongoing 'host' trial. There are potential scientific, logistical and ethical obstacles to such studies. Methods Telephone interviews were undertaken with four groups of stakeholders (funders, principal investigators, trial managers and ethics committee chairs) to explore their views on the practicality and acceptability of undertaking nested trials of recruitment methods. These semi-structured interviews were transcribed and analysed thematically. Results Twenty people were interviewed. Respondents were familiar with recruitment difficulties in primary care and recognised the case for 'nested' studies to build an evidence base on effective recruitment strategies. However, enthusiasm for this global aim was tempered by the challenges of implementation. Challenges for host studies included increasing complexity and management burden; compatibility between the host and nested study; and the impact of the nested study on trial design and relationships with collaborators. For nested recruitment studies, there were concerns that host study investigators might have strong preferences, limiting the nested study investigators' control over their research, and also concerns about sample size which might limit statistical power. Nested studies needed to be compatible with the main trial and should be planned from the outset. Good communication and adequate resources were seen as important. Conclusions Although research on recruitment was welcomed in principle, the issue of which study had control of key decisions emerged as critical. To address this concern, it appeared important to align the interests of both host and nested studies and to reduce the burden of hosting a recruitment trial. These findings should prove

  18. TRIAL BURNS: METHODS PERSPECTIVE

    EPA Science Inventory

    When conducting a trial burn, it is necessary to make a number of measurements in order to adequately define the performance of the incinerator. n addition to flue gas emissions for particulate matter, HCl, and selected organics, it is also necessary to measure selected organics ...

  19. Arabidopsis: An Adequate Model for Dicot Root Systems?

    PubMed

    Zobel, Richard W

    2016-01-01

    The Arabidopsis root system is frequently considered to have only three classes of root: primary, lateral, and adventitious. Research with other plant species has suggested up to eight different developmental/functional classes of root for a given plant root system. If Arabidopsis has only three classes of root, it may not be an adequate model for eudicot plant root systems. Recent research, however, can be interpreted to suggest that pre-flowering Arabidopsis does have at least five (5) of these classes of root. This then suggests that Arabidopsis root research can be considered an adequate model for dicot plant root systems. PMID:26904040

  20. Assessing overall evidence from noninferiority trials with shared historical data.

    PubMed

    Soon, Guoxing; Zhang, Zhiwei; Tsong, Yi; Nie, Lei

    2013-06-30

    For regulatory approval of a new drug, the United States Code of Federal Regulations (CFR) requires 'substantial evidence' from 'adequate and well-controlled investigations'. This requirement is interpreted in the Food and Drug Administration guidance as the need of 'at least two adequate and well-controlled studies, each convincing on its own to establish effectiveness'. The guidance also emphasizes the need of 'independent substantiation of experimental results from multiple studies'. However, several authors have noted the loss of independence between two noninferiority trials that use the same set of historical data to make inferences, raising questions about whether the CFR requirement is met in noninferiority trials through current practice. In this article, we first propose a statistical interpretation of the CFR requirement in terms of trial-level and overall type I error rates, which captures the essence of the requirement and can be operationalized for noninferiority trials. We next examine four typical regulatory settings in which the proposed requirement may or may not be fulfilled by existing methods of analysis (fixed margin and synthesis). In situations where the criteria are not met, we then propose adjustments to the existing methods. As illustrated with several examples, our results and findings can be helpful in designing and analyzing noninferiority trials in a way that is both compliant with the regulatory interpretation of the CFR requirement and reasonably powerful. PMID:22987631

  1. Missing data in randomized controlled trials testing palliative interventions pose a significant risk of bias and loss of power: a systematic review and meta-analyses

    PubMed Central

    Hussain, Jamilla A.; White, Ian R.; Langan, Dean; Johnson, Miriam J.; Currow, David C.; Torgerson, David J.; Bland, Martin

    2016-01-01

    Objectives To assess the risk posed by missing data (MD) to the power and validity of trials evaluating palliative interventions. Study Design and Setting A systematic review of MD in published randomized controlled trials (RCTs) of palliative interventions in participants with life-limiting illnesses was conducted, and random-effects meta-analyses and metaregression were performed. CENTRAL, MEDLINE, and EMBASE (2009–2014) were searched with no language restrictions. Results One hundred and eight RCTs representing 15,560 patients were included. The weighted estimate for MD at the primary endpoint was 23.1% (95% confidence interval [CI] 19.3, 27.4). Larger MD proportions were associated with increasing numbers of questions/tests requested (odds ratio [OR], 1.19; 95% CI 1.05, 1.35) and with longer study duration (OR, 1.09; 95% CI 1.02, 1.17). Meta-analysis found evidence of differential rates of MD between trial arms, which varied in direction (OR, 1.04; 95% CI 0.90, 1.20; I2 35.9, P = 0.001). Despite randomization, MD in the intervention arms (vs. control) were more likely to be attributed to disease progression unrelated to the intervention (OR, 1.31; 95% CI 1.02, 1.69). This was not the case for MD due to death (OR, 0.92; 95% CI 0.78, 1.08). Conclusion The overall proportion and differential rates and reasons for MD reduce the power and potentially introduce bias to palliative care trials. PMID:26718729

  2. Is the Marketing Concept Adequate for Continuing Education?

    ERIC Educational Resources Information Center

    Rittenburg, Terri L.

    1984-01-01

    Because educators have a social responsibility to those they teach, the marketing concept may not be adequate as a philosophy for continuing education. In attempting to broaden the audience for continuing education, educators should consider a societal marketing concept to meet the needs of the educationally disadvantaged. (SK)

  3. 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…

  4. 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 AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION...

  5. 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 Rates.…

  6. Assessing Juvenile Sex Offenders to Determine Adequate Levels of Supervision.

    ERIC Educational Resources Information Center

    Gerdes, Karen E.; And Others

    1995-01-01

    This study analyzed the internal consistency of four inventories used by Utah probation officers to determine adequate and efficacious supervision levels and placement for juvenile sex offenders. Three factors accounted for 41.2 percent of variance (custodian's and juvenile's attitude toward intervention, offense characteristics, and historical…

  7. 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...

  8. 34 CFR 200.20 - Making adequate yearly progress.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 1 2011-07-01 2011-07-01 false Making adequate yearly progress. 200.20 Section 200.20 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 DISADVANTAGED...

  9. 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…

  10. Maintaining adequate hydration and nutrition in adult enteral tube feeding.

    PubMed

    Dunn, Sasha

    2015-01-01

    Predicting the nutritional and fluid requirements of enterally-fed patients can be challenging and the practicalities of ensuring adequate delivery must be taken into consideration. Patients who are enterally fed can be more reliant on clinicians, family members and carers to meet their nutrition and hydration needs and identify any deficiencies, excesses or problems with delivery. Estimating a patient's requirements can be challenging due to the limitations of using predictive equations in the clinical setting. Close monitoring by all those involved in the patient's care, as well as regular review by a dietitian, is therefore required to balance the delivery of adequate feed and fluids to meet each patient's individual needs and prevent the complications of malnutrition and dehydration. Increasing the awareness of the signs of malnutrition and dehydration in patients receiving enteral tube feeding among those involved in a patient's care will help any deficiencies to be detected early on and rectified before complications occur. PMID:26087203

  11. Assessing juvenile sex offenders to determine adequate levels of supervision.

    PubMed

    Gerdes, K E; Gourley, M M; Cash, M C

    1995-08-01

    The present study analyzed the internal consistency of four inventories currently being used by probation officers in the state of Utah to determine adequate and efficacious supervision levels and placement for juvenile sex offenders. The internal consistency or reliability of the inventories ranged from moderate to good. Factor analysis was utilized to significantly increase the reliability of the four inventories by collapsing them into the following three factors: (a) Custodian's and Juvenile's Attitude Toward Intervention; (b) Offense Characteristics; and (c) Historical Risk Factors. These three inventories/factors explained 41.2% of the variance in the combined inventories' scores. Suggestions are made regarding the creation of an additional inventory. "Characteristics of the Victim" to account for more of the variance. In addition, suggestions as to how these inventories can be used by probation officers to make objective and consistent decisions about adequate supervision levels and placement for juvenile sex offenders are discussed. PMID:7583754

  12. MindTrial: An Intelligent System for Clinical Trials

    PubMed Central

    Lee, Yugyung; Dinakarpandian, Deendayal; Katakam, Nikhilesh; Owens, Dennis

    2010-01-01

    The recruitment of human subjects for clinical trials research is a critically important step in the discovery of new cures for diseases. However, the current recruitment methodologies are inherently inefficient. Considerable resources are expended in efforts to recruit adequate numbers of patient volunteers who meet the inclusion/exclusion criteria for clinical trials. Recruitment is particularly challenging for trials involving vulnerable, psychiatrically disordered groups. We have developed a prototype system, called MindTrial, that is based on an online model to enhance the efficiency and quality of recruitment of patients with psychiatric disorders for clinical research. The intelligent component of the MindTrial system can facilitate highly specific matches between clinical trial criteria and volunteers for self-enrollment of sufficient numbers of patient volunteers. We believe this system is particularly valuable in optimizing recruitment for clinical trial studies for development of new drugs. PMID:21347017

  13. 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

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

    PubMed

    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

  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. Human Subject Protection In India – Is It Adequate?

    PubMed Central

    Mahaluxmivala, Narges

    2010-01-01

    India′s experience in clinical trials is shorter in time than that of the developed countries but as in everything else in the current globalizing environment, business compulsions characterized by compressed timelines are strong persuaders to catch up. Most global pharmaceutical and biotechnology organizations include India in their strategic plans, Immediate implementation of aspects that attract benefit are an urgent necessity. Technical and ethical issues that remain unresolved constrain India from reaching its deserved potential. To take fullest advantage of the current inflow of clinical trials, India must adopt, without delay, an all-inclusive approach and invest in a widespread and comprehensive GCP-compliance programme taking into account India-related cultural and socioeconomic issues. The initiative should not be allowed to flag. Government, the pharmaceutical and biotechnological research industries, the medical and pharmacy profession including relevant training institutes, the media and the public have a stake in such investment. The programme should involve assessing gaps in current clinical trial compliance measures and possible solutions, set the field for rectification and ensure implementation through mandate and penalty as feasible. PMID:21829776

  17. Human subject protection in India - is it adequate?

    PubMed

    Mahaluxmivala, Narges

    2010-01-01

    India's experience in clinical trials is shorter in time than that of the developed countries but as in everything else in the current globalizing environment, business compulsions characterized by compressed timelines are strong persuaders to catch up. Most global pharmaceutical and biotechnology organizations include India in their strategic plans, Immediate implementation of aspects that attract benefit are an urgent necessity. Technical and ethical issues that remain unresolved constrain India from reaching its deserved potential. To take fullest advantage of the current inflow of clinical trials, India must adopt, without delay, an all-inclusive approach and invest in a widespread and comprehensive GCP-compliance programme taking into account India-related cultural and socioeconomic issues. The initiative should not be allowed to flag. Government, the pharmaceutical and biotechnological research industries, the medical and pharmacy profession including relevant training institutes, the media and the public have a stake in such investment. The programme should involve assessing gaps in current clinical trial compliance measures and possible solutions, set the field for rectification and ensure implementation through mandate and penalty as feasible. PMID:21829776

  18. Reproducibility of Outdoor Flat and Uphill Cycling Time Trials and Their Performance Correlates with Peak Power Output in Moderately Trained Cyclists

    PubMed Central

    Tan, Frankie H. Y.; Aziz, Abdul Rashid

    2005-01-01

    The aims of the present study were firstly to examine the reproducibility of outdoor flat and uphill cycling time trials (TT), and secondly to assess the relationship between peak power output (Wpeak) obtained in the laboratory and outdoor cycling performance in moderately trained cyclists. Eight competitive male cyclists first performed a progressive cycle ergometer test in the laboratory to determine Wpeak (W). Thereafter, they performed three 36 km TT (TT36) on a flat course on separate days and at the same time of the day. On a different day, they also performed three 1.4 km uphill TT (TT1.4) in a single day. The coefficient of variation (CV) values across three TT36 and TT1.4 ranged from 1.1 - 1.4% and 2.6 - 2.9%, for performance time (min) and mean power (W), respectively. The correlation between absolute Wpeak (W) obtained in the laboratory and mean power during TT36 and TT1.4 was 0.90 (p < 0.01) and 0.98 (p < 0.01), respectively. Absolute Wpeak (W) correlated significantly with performance time in TT36 (r = -0.72, p < 0.05) but not in TT1.4 (r = -0.52, p > 0.05). The correlation between relative Wpeak (W·kg-1) and performance time in TT36 and TT1.4 was r = -0.65 (p > 0.05) and r = -0.91 (p < 0.01), respectively. In conclusion, under stable environmental conditions, performance time and mean power are highly reproducible in moderately trained cyclists during outdoor cycling TT. Laboratory determined absolute Wpeak (W) may predict cycling performance on a flat course but relative Wpeak (W·kg-1) is a better predictor of performance during uphill cycling. Key Points Under stable environmental conditions, performance time and mean power are highly reproducible in moderately trained cyclists during outdoor flat and uphill cycling time trials. Laboratory determined peak power output (Wpeak) (W) may predict cycling performance on a flat course. Laboratory determined relative Wpeak (W·kg-1) is a better predictor of performance during uphill cycling PMID:24453532

  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. Purchasing a cycle helmet: are retailers providing adequate advice?

    PubMed Central

    Plumridge, E.; McCool, J.; Chetwynd, J.; Langley, J. D.

    1996-01-01

    OBJECTIVES: The aim of this study was to examine the selling of cycle helmets in retail stores with particular reference to the adequacy of advice offered about the fit and securing of helmets. METHODS: All 55 retail outlets selling cycle helmets in Christchurch, New Zealand were studied by participant observation. A research entered each store as a prospective customer and requested assistance to purchase a helmet. She took detailed field notes of the ensuing encounter and these were subsequently transcribed, coded, and analysed. RESULTS: Adequate advice for helmet purchase was given in less than half of the stores. In general the sales assistants in specialist cycle shops were better informed and gave more adequate advice than those in department stores. Those who have good advice also tended to be more good advice also tended to be more active in helping with fitting the helmet. Knowledge about safety standards was apparent in one third of sales assistants. Few stores displayed information for customers about the correct fit of cycle helmets. CONCLUSIONS: These findings suggest that the advice and assistance being given to ensure that cycle helmets fit properly is often inadequate and thus the helmets may fail to fulfil their purpose in preventing injury. Consultation between retailers and policy makers is a necessary first step to improving this situation. PMID:9346053

  1. Adequate drainage system design for heap leaching structures.

    PubMed

    Majdi, Abbas; Amini, Mehdi; Nasab, Saeed Karimi

    2007-08-17

    The paper describes an optimum design of a drainage system for a heap leaching structure which has positive impacts on both mine environment and mine economics. In order to properly design a drainage system the causes of an increase in the acid level of the heap which in turn produces severe problems in the hydrometallurgy processes must be evaluated. One of the most significant negative impacts induced by an increase in the acid level within a heap structure is the increase of pore acid pressure which in turn increases the potential of a heap-slide that may endanger the mine environment. In this paper, initially the thickness of gravelly drainage layer is determined via existing empirical equations. Then by assuming that the calculated thickness is constant throughout the heap structure, an approach has been proposed to calculate the required internal diameter of the slotted polyethylene pipes which are used for auxiliary drainage purposes. In order to adequately design this diameter, the pipe's cross-sectional deformation due to stepped heap structure overburden pressure is taken into account. Finally, a design of an adequate drainage system for the heap structure 2 at Sarcheshmeh copper mine is presented and the results are compared with those calculated by exiting equations. PMID:17321044

  2. Field Trial on a Rack-mounted DC Power Supply System with 80-Ah Lithium-ion Batteries

    NASA Astrophysics Data System (ADS)

    Matsushima, Toshio

    Using an industrial lithium-ion battery that has higher energy density than conventional valve-regulated lead-acid batteries, a rack-mounted DC-power-supply system was assembled and tested at a base transceiver station (BTS) offering actual services. A nominal output voltage and maximum output current of the system is 53.5V and 20A, respectively. An 80-Ah lithium-ion battery composed of 13 cells connected in series was applied in the system and maintained in a floating charge method. The DC-power-supply system was installed in a 19-inch power rack in the telecommunications equipment box at BTS. The characteristics of the 80Ah lithium-ion battery, specifications of the DC-power-supply system and field-test results were shown in this paper.

  3. 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

  4. Are PPS payments adequate? Issues for updating and assessing rates

    PubMed Central

    Sheingold, Steven H.; Richter, Elizabeth

    1992-01-01

    Declining operating margins under Medicare's prospective payment system (PPS) have focused attention on the adequacy of payment rates. The question of whether annual updates to the rates have been too low or cost increases too high has become important. In this article we discuss issues relevant to updating PPS rates and judging their adequacy. We describe a modification to the current framework for recommending annual update factors. This framework is then used to retrospectively assess PPS payment and cost growth since 1985. The preliminary results suggest that current rates are more than adequate to support the cost of efficient care. Also discussed are why using financial margins to evaluate rates is problematic and alternative methods that might be employed. PMID:10127450

  5. Analyzing indirect effects in cluster randomized trials. The effect of estimation method, number of groups and group sizes on accuracy and power

    PubMed Central

    Hox, Joop J.; Moerbeek, Mirjam; Kluytmans, Anouck; van de Schoot, Rens

    2013-01-01

    Cluster randomized trials assess the effect of an intervention that is carried out at the group or cluster level. Ajzen's theory of planned behavior is often used to model the effect of the intervention as an indirect effect mediated in turn by attitude, norms and behavioral intention. Structural equation modeling (SEM) is the technique of choice to estimate indirect effects and their significance. However, this is a large sample technique, and its application in a cluster randomized trial assumes a relatively large number of clusters. In practice, the number of clusters in these studies tends to be relatively small, e.g., much less than fifty. This study uses simulation methods to find the lowest number of clusters needed when multilevel SEM is used to estimate the indirect effect. Maximum likelihood estimation is compared to Bayesian analysis, with the central quality criteria being accuracy of the point estimate and the confidence interval. We also investigate the power of the test for the indirect effect. We conclude that Bayes estimation works well with much smaller cluster level sample sizes such as 20 cases than maximum likelihood estimation; although the bias is larger the coverage is much better. When only 5–10 clusters are available per treatment condition even with Bayesian estimation problems occur. PMID:24550881

  6. Analyzing indirect effects in cluster randomized trials. The effect of estimation method, number of groups and group sizes on accuracy and power.

    PubMed

    Hox, Joop J; Moerbeek, Mirjam; Kluytmans, Anouck; van de Schoot, Rens

    2014-01-01

    Cluster randomized trials assess the effect of an intervention that is carried out at the group or cluster level. Ajzen's theory of planned behavior is often used to model the effect of the intervention as an indirect effect mediated in turn by attitude, norms and behavioral intention. Structural equation modeling (SEM) is the technique of choice to estimate indirect effects and their significance. However, this is a large sample technique, and its application in a cluster randomized trial assumes a relatively large number of clusters. In practice, the number of clusters in these studies tends to be relatively small, e.g., much less than fifty. This study uses simulation methods to find the lowest number of clusters needed when multilevel SEM is used to estimate the indirect effect. Maximum likelihood estimation is compared to Bayesian analysis, with the central quality criteria being accuracy of the point estimate and the confidence interval. We also investigate the power of the test for the indirect effect. We conclude that Bayes estimation works well with much smaller cluster level sample sizes such as 20 cases than maximum likelihood estimation; although the bias is larger the coverage is much better. When only 5-10 clusters are available per treatment condition even with Bayesian estimation problems occur. PMID:24550881

  7. A critical appraisal of the evidence for using cardiotocography plus ECG ST interval analysis for fetal surveillance in labor. Part I: the randomized controlled trials

    PubMed Central

    Olofsson, Per; Ayres-de-Campos, Diogo; Kessler, Jörg; Tendal, Britta; Yli, Branka M; Devoe, Lawrence

    2014-01-01

    We reappraised the five randomized controlled trials that compared cardiotocography plus ECG ST interval analysis (CTG+ST) vs. cardiotocography. The numbers enrolled ranged from 5681 (Dutch randomized controlled trial) to 799 (French randomized controlled trial). The Swedish randomized controlled trial (n = 5049) was the only trial adequately powered to show a difference in metabolic acidosis, and the Plymouth randomized controlled trial (n = 2434) was only powered to show a difference in operative delivery for fetal distress. There were considerable differences in study design: the French randomized controlled trial used different inclusion criteria, and the Finnish randomized controlled trial (n = 1483) used a different metabolic acidosis definition. In the CTG+ST study arms, the larger Plymouth, Swedish and Dutch trials showed lower operative delivery and metabolic acidosis rates, whereas the smaller Finnish and French trials showed minor differences in operative delivery and higher metabolic acidosis rates. We conclude that the differences in outcomes are likely due to the considerable differences in study design and size. This will enhance heterogeneity effects in any subsequent meta-analysis. PMID:24797452

  8. Smoke alarm tests may not adequately indicate smoke alarm function.

    PubMed

    Peek-Asa, Corinne; Yang, Jingzhen; Hamann, Cara; Young, Tracy

    2011-01-01

    Smoke alarms are one of the most promoted prevention strategies to reduce residential fire deaths, and they can reduce residential fire deaths by half. Smoke alarm function can be measured by two tests: the smoke alarm button test and the chemical smoke test. Using results from a randomized trial of smoke alarms, we compared smoke alarm response to the button test and the smoke test. The smoke alarms found in the study homes at baseline were tested, as well as study alarms placed into homes as part of the randomized trial. Study alarms were tested at 12 and 42 months postinstallation. The proportion of alarms that passed the button test but not the smoke test ranged from 0.5 to 5.8% of alarms; this result was found most frequently among ionization alarms with zinc or alkaline batteries. These alarms would indicate to the owner (through the button test) that the smoke alarm was working, but the alarm would not actually respond in the case of a fire (as demonstrated by failing the smoke test). The proportion of alarms that passed the smoke test but not the button test ranged from 1.0 to 3.0%. These alarms would appear nonfunctional to the owner (because the button test failed), even though the alarm would operate in response to a fire (as demonstrated by passing the smoke test). The general public is not aware of the potential for inaccuracy in smoke alarm tests, and burn professionals can advocate for enhanced testing methods. The optimal test to determine smoke alarm function is the chemical smoke test. PMID:21747329

  9. 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. PMID:24085183

  10. A Randomized Controlled Trial of POWER: An Internet-Based HIV Prevention Intervention for Black Bisexual Men.

    PubMed

    Fernandez, M Isabel; Hosek, Sybil G; Hotton, Anna L; Gaylord, Sanford E; Hernandez, Nilda; Alfonso, Sarah V; Joseph, Heather

    2016-09-01

    POWER is a theory-based, on-line HIV prevention intervention developed specifically for Black men who have sex with men and women (BMSMW), an understudied group significantly impacted by HIV. To test its efficacy, we recruited 224 BMSMW using chain referral methods and randomly assigned 108 to POWER and 103 to a health information comparison condition. Three months after the intervention, participants assigned to POWER had lower odds of reporting any condomless vaginal or condomless anal intercourse (CVAI) compared to those in the comparison group (aOR = 0.49; 95 % CI 0.25-0.98; p = 0.044). The intervention was associated with significantly lower odds of condomless anal intercourse with male partners (aOR = 0.55; 95 % CI 0.34-0.91; p = 0.020) but not with female partners and serodiscordant sex with male partners but not with female partners. Future studies are needed to replicate these findings in larger and more diverse samples of BMSMW and to understand the underlying mechanisms through which intervention efficacy was achieved. PMID:27085548

  11. 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.

  12. 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.

  13. Adequate peritoneal dialysis: theoretical model and patient treatment.

    PubMed

    Tast, C

    1998-01-01

    The objective of this study was to evaluate the relationship between adequate PD with sufficient weekly Kt/V (2.0) and Creatinine clearance (CCR) (60l) and necessary daily dialysate volume. This recommended parameter was the result of a recent multi-centre study (CANUSA). For this there were 40 patients in our hospital examined and compared in 1996, who carried out PD for at least 8 weeks and up to 6 years. These goals (CANUSA) are easily attainable in the early treatment of many individuals with a low body surface area (BSA). With higher BSA or missing RRF (Residual Renal Function) the daily dose of dialysis must be adjusted. We found it difficult to obtain the recommended parameters and tried to find a solution to this problem. The simplest method is to increase the volume or exchange rate. The most expensive method is to change from CAPD to APD with the possibility of higher volume or exchange rates. Selection of therapy must take into consideration: 1. patient preference, 2. body mass, 3. peritoneal transport rates, 4. ability to perform therapy, 5. cost of therapy and 6. risk of peritonitis. With this information in mind, an individual prescription can be formulated and matched to the appropriate modality of PD. PMID:10392062

  14. DARHT - an `adequate` EIS: A NEPA case study

    SciTech Connect

    Webb, M.D.

    1997-08-01

    The Dual Axis Radiographic Hydrodynamic Test (DARHT) Facility Environmental Impact Statement (EIS) provides a case study that is interesting for many reasons. The EIS was prepared quickly, in the face of a lawsuit, for a project with unforeseen environmental impacts, for a facility that was deemed urgently essential to national security. Following judicial review the EIS was deemed to be {open_quotes}adequate.{close_quotes} DARHT is a facility now being built at Los Alamos National Laboratory (LANL) as part of the Department of Energy (DOE) nuclear weapons stockpile stewardship program. DARHT will be used to evaluate the safety and reliability of nuclear weapons, evaluate conventional munitions and study high-velocity impact phenomena. DARHT will be equipped with two accelerator-driven, high-intensity X-ray machines to record images of materials driven by high explosives. DARHT will be used for a variety of hydrodynamic tests, and DOE plans to conduct some dynamic experiments using plutonium at DARHT as well.

  15. 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…

  16. Clinical trial simulation to evaluate power to compare the antiviral effectiveness of two hepatitis C protease inhibitors using nonlinear mixed effect models: a viral kinetic approach

    PubMed Central

    2013-01-01

    Background Models of hepatitis C virus (HCV) kinetics are increasingly used to estimate and to compare in vivo drug’s antiviral effectiveness of new potent anti-HCV agents. Viral kinetic parameters can be estimated using non-linear mixed effect models (NLMEM). Here we aimed to evaluate the performance of this approach to precisely estimate the parameters and to evaluate the type I errors and the power of the Wald test to compare the antiviral effectiveness between two treatment groups when data are sparse and/or a large proportion of viral load (VL) are below the limit of detection (BLD). Methods We performed a clinical trial simulation assuming two treatment groups with different levels of antiviral effectiveness. We evaluated the precision and the accuracy of parameter estimates obtained on 500 replication of this trial using the stochastic approximation expectation-approximation algorithm which appropriately handles BLD data. Next we evaluated the type I error and the power of the Wald test to assess a difference of antiviral effectiveness between the two groups. Standard error of the parameters and Wald test property were evaluated according to the number of patients, the number of samples per patient and the expected difference in antiviral effectiveness. Results NLMEM provided precise and accurate estimates for both the fixed effects and the inter-individual variance parameters even with sparse data and large proportion of BLD data. However Wald test with small number of patients and lack of information due to BLD resulted in an inflation of the type I error as compared to the results obtained when no limit of detection of VL was considered. The corrected power of the test was very high and largely outperformed what can be obtained with empirical comparison of the mean VL decline using Wilcoxon test. Conclusion This simulation study shows the benefit of viral kinetic models analyzed with NLMEM over empirical approaches used in most clinical studies. When

  17. 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

  18. Improving access to adequate pain management in Taiwan.

    PubMed

    Scholten, Willem

    2015-06-01

    There is a global crisis in access to pain management in the world. WHO estimates that 4.65 billion people live in countries where medical opioid consumption is near to zero. For 2010, WHO considered a per capita consumption of 216.7 mg morphine equivalents adequate, while Taiwan had a per capita consumption of 0.05 mg morphine equivalents in 2007. In Asia, the use of opioids is sensitive because of the Opium Wars in the 19th century and for this reason, the focus of controlled substances policies has been on the prevention of diversion and dependence. However, an optimal public health outcome requires that also the beneficial aspects of these substances are acknowledged. Therefore, WHO recommends a policy based on the Principle of Balance: ensuring access for medical and scientific purposes while preventing diversion, harmful use and dependence. Furthermore, international law requires that countries ensure access to opioid analgesics for medical and scientific purposes. There is evidence that opioid analgesics for chronic pain are not associated with a major risk for developing dependence. Barriers for access can be classified in the categories of overly restrictive laws and regulations; insufficient medical training on pain management and problems related to assessment of medical needs; attitudes like an excessive fear for dependence or diversion; and economic and logistical problems. The GOPI project found many examples of such barriers in Asia. Access to opioid medicines in Taiwan can be improved by analysing the national situation and drafting a plan. The WHO policy guidelines Ensuring Balance in National Policies on Controlled Substances can be helpful for achieving this purpose, as well as international guidelines for pain treatment. PMID:26068436

  19. SNAP benefits: Can an adequate benefit be defined?

    PubMed

    Yaktine, Ann L; Caswell, Julie A

    2014-01-01

    The Supplemental Nutrition Assistance Program (SNAP) increases the food purchasing power of participating households. A committee convened by the Institute of Medicine (IOM) examined the question of whether it is feasible to define SNAP allotment adequacy. Total resources; individual, household, and environmental factors; and SNAP program characteristics that affect allotment adequacy were identified from a framework developed by the IOM committee. The committee concluded that it is feasible to define SNAP allotment adequacy; however, such a definition must take into account the degree to which participants' total resources and individual, household, and environmental factors influence the purchasing power of SNAP benefits and the impact of SNAP program characteristics on the calculation of the dollar value of the SNAP allotment. The committee recommended that the USDA Food and Nutrition Service investigate ways to incorporate these factors and program characteristics into research aimed at defining allotment adequacy. PMID:24425718

  20. Harnessing the power of disgust: a randomized trial to reduce high-calorie food appeal through implicit priming1

    PubMed Central

    Legget, Kristina T; Cornier, Marc-Andre; Rojas, Donald C; Lawful, Benjamin; Tregellas, Jason R

    2015-01-01

    IP (P < 0.007), which suggested lasting effects. Conclusion: This study provides initial evidence that IP can be used to alter high-calorie food preferences, which could promote healthier eating habits. This trial was registered at clinicaltrials.gov as NCT02347527. PMID:26109580

  1. Traditional and new composite endpoints in heart failure clinical trials: facilitating comprehensive efficacy assessments and improving trial efficiency.

    PubMed

    Anker, Stefan D; Schroeder, Stefan; Atar, Dan; Bax, Jeroen J; Ceconi, Claudio; Cowie, Martin R; Crisp, Adam; Dominjon, Fabienne; Ford, Ian; Ghofrani, Hossein-Ardeschir; Gropper, Savion; Hindricks, Gerhard; Hlatky, Mark A; Holcomb, Richard; Honarpour, Narimon; Jukema, J Wouter; Kim, Albert M; Kunz, Michael; Lefkowitz, Martin; Le Floch, Chantal; Landmesser, Ulf; McDonagh, Theresa A; McMurray, John J; Merkely, Bela; Packer, Milton; Prasad, Krishna; Revkin, James; Rosano, Giuseppe M C; Somaratne, Ransi; Stough, Wendy Gattis; Voors, Adriaan A; Ruschitzka, Frank

    2016-05-01

    Composite endpoints are commonly used as the primary measure of efficacy in heart failure clinical trials to assess the overall treatment effect and to increase the efficiency of trials. Clinical trials still must enrol large numbers of patients to accrue a sufficient number of outcome events and have adequate power to draw conclusions about the efficacy and safety of new treatments for heart failure. Additionally, the societal and health system perspectives on heart failure have raised interest in ascertaining the effects of therapy on outcomes such as repeat hospitalization and the patient's burden of disease. Thus, novel methods for using composite endpoints in clinical trials (e.g. clinical status composite endpoints, recurrent event analyses) are being applied in current and planned trials. Endpoints that measure functional status or reflect the patient experience are important but used cautiously because heart failure treatments may improve function yet have adverse effects on mortality. This paper discusses the use of traditional and new composite endpoints, identifies qualities of robust composites, and outlines opportunities for future research. PMID:27071916

  2. 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. PMID:23834353

  3. Rectal cancer delivery of radiotherapy in adequate time and with adequate dose is influenced by treatment center, treatment schedule, and gender and is prognostic parameter for local control: Results of study CAO/ARO/AIO-94

    SciTech Connect

    Fietkau, Rainer . E-mail: rainer.fietkau@med.uni-rostock.de; Roedel, Claus; Hohenberger, Werner; Raab, Rudolf; Hess, Clemens; Liersch, Torsten; Becker, Heinz; Wittekind, Christian; Hutter, Matthias; Hager, Eva; Karstens, Johann; Ewald, Hermann; Christen, Norbert; Jagoditsch, Michael; Martus, Peter; Sauer, Rolf

    2007-03-15

    Purpose: The impact of the delivery of radiotherapy (RT) on treatment results in rectal cancer patients is unknown. Methods and Materials: The data from 788 patients with rectal cancer treated within the German CAO/AIO/ARO-94 phase III trial were analyzed concerning the impact of the delivery of RT (adequate RT: minimal radiation RT dose delivered, 4300 cGy for neoadjuvant RT or 4700 cGy for adjuvant RT; completion of RT in <44 days for neoadjuvant RT or <49 days for adjuvant RT) in different centers on the locoregional recurrence rate (LRR) and disease-free survival (DFS) at 5 years. The LRR, DFS, and delivery of RT were analyzed as endpoints in multivariate analysis. Results: A significant difference was found between the centers and the delivery of RT. The overall delivery of RT was a prognostic factor for the LRR (no RT, 29.6% {+-} 7.8%; inadequate RT, 21.2% {+-} 5.6%; adequate RT, 6.8% {+-} 1.4%; p = 0.0001) and DFS (no RT, 55.1% {+-} 9.1%; inadequate RT, 57.4% {+-} 6.3%; adequate RT, 69.1% {+-} 2.3%; p = 0.02). Postoperatively, delivery of RT was a prognostic factor for LRR on multivariate analysis (together with pathologic stage) but not for DFS (independent parameters, pathologic stage and age). Preoperatively, on multivariate analysis, pathologic stage, but not delivery of RT, was an independent prognostic parameter for LRR and DFS (together with adequate chemotherapy). On multivariate analysis, the treatment center, treatment schedule (neoadjuvant vs. adjuvant RT), and gender were prognostic parameters for adequate RT. Conclusion: Delivery of RT should be regarded as a prognostic factor for LRR in rectal cancer and is influenced by the treatment center, treatment schedule, and patient gender.

  4. Clinical Trials

    MedlinePlus

    Clinical trials are research studies that test how well new medical approaches work in people. Each study answers ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a ...

  5. Clinical Trials

    MedlinePlus

    Clinical trials are research studies that test how well new medical approaches work in people. Each study ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to ...

  6. 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

  7. The Public Repository of Xenografts Enables Discovery and Randomized Phase II-like Trials in Mice.

    PubMed

    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

    2016-04-11

    More than 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, publicly available repository of well-characterized leukemia and lymphoma PDXs that undergo orthotopic engraftment, called the Public Repository of Xenografts (PRoXe). 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-naive and relapsed/refractory disease. PMID:27070704

  8. Percentage of Adults with High Blood Pressure Whose Hypertension Is Adequately Controlled

    MedlinePlus

    ... is Adequately Controlled Percentage of Adults with High Blood Pressure Whose Hypertension is Adequately Controlled Heart disease ... Survey. Age Group Percentage of People with High Blood Pressure that is Controlled by Age Group f94q- ...

  9. 21 CFR 514.117 - Adequate and well-controlled studies.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... production performance, or biased observation. One or more adequate and well-controlled studies are required... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Adequate and well-controlled studies. 514.117... Applications § 514.117 Adequate and well-controlled studies. (a) Purpose. The primary purpose of...

  10. 21 CFR 514.117 - Adequate and well-controlled studies.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... production performance, or biased observation. One or more adequate and well-controlled studies are required... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Adequate and well-controlled studies. 514.117... Applications § 514.117 Adequate and well-controlled studies. (a) Purpose. The primary purpose of...

  11. 21 CFR 514.117 - Adequate and well-controlled studies.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... production performance, or biased observation. One or more adequate and well-controlled studies are required... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Adequate and well-controlled studies. 514.117... Applications § 514.117 Adequate and well-controlled studies. (a) Purpose. The primary purpose of...

  12. 21 CFR 514.117 - Adequate and well-controlled studies.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... production performance, or biased observation. One or more adequate and well-controlled studies are required... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Adequate and well-controlled studies. 514.117... Applications § 514.117 Adequate and well-controlled studies. (a) Purpose. The primary purpose of...

  13. 21 CFR 514.117 - Adequate and well-controlled studies.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... production performance, or biased observation. One or more adequate and well-controlled studies are required... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Adequate and well-controlled studies. 514.117... Applications § 514.117 Adequate and well-controlled studies. (a) Purpose. The primary purpose of...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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... Standards and Maintaining Adequate Iron Stores in Blood Donors.'' The purpose of this public workshop is to... donor safety and blood availability, and potential measures to maintain adequate iron stores in...

  20. 36 CFR 13.960 - Who determines when there is adequate snow cover?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... adequate snow cover? 13.960 Section 13.960 Parks, Forests, and Public Property NATIONAL PARK SERVICE... Preserve Snowmachine (snowmobile) Operations § 13.960 Who determines when there is adequate snow cover? The superintendent will determine when snow cover is adequate for snowmachine use. The superintendent will follow...

  1. 36 CFR 13.960 - Who determines when there is adequate snow cover?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... adequate snow cover? 13.960 Section 13.960 Parks, Forests, and Public Property NATIONAL PARK SERVICE... Preserve Snowmachine (snowmobile) Operations § 13.960 Who determines when there is adequate snow cover? The superintendent will determine when snow cover is adequate for snowmachine use. The superintendent will follow...

  2. 36 CFR 13.960 - Who determines when there is adequate snow cover?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... adequate snow cover? 13.960 Section 13.960 Parks, Forests, and Public Property NATIONAL PARK SERVICE... Preserve Snowmachine (snowmobile) Operations § 13.960 Who determines when there is adequate snow cover? The superintendent will determine when snow cover is adequate for snowmachine use. The superintendent will follow...

  3. 36 CFR 13.960 - Who determines when there is adequate snow cover?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... adequate snow cover? 13.960 Section 13.960 Parks, Forests, and Public Property NATIONAL PARK SERVICE... Preserve Snowmachine (snowmobile) Operations § 13.960 Who determines when there is adequate snow cover? The superintendent will determine when snow cover is adequate for snowmachine use. The superintendent will follow...

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

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... adequate snow cover? 13.960 Section 13.960 Parks, Forests, and Public Property NATIONAL PARK SERVICE... Preserve Snowmachine (snowmobile) Operations § 13.960 Who determines when there is adequate snow cover? The superintendent will determine when snow cover is adequate for snowmachine use. The superintendent will follow...

  5. 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

  6. 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

  7. 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…

  8. 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.

  9. Clinical Trials

    MedlinePlus

    ... of visits, and any adjustments to treatment. (back) Requirements for Participation Admission into a clinical trial is based on a rigid set of requirements. You must be diagnosed with the illness that ...

  10. 21 CFR 314.126 - Adequate and well-controlled studies.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...-evident (general anesthetics, drug metabolism). (3) The method of selection of subjects provides adequate... respect to pertinent variables such as age, sex, severity of disease, duration of disease, and use of... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Adequate and well-controlled studies....

  11. 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...

  12. 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...

  13. Calculation of the Cost of an Adequate Education in Kentucky: A Professional Judgment Approach

    ERIC Educational Resources Information Center

    Verstegen, Deborah A.

    2004-01-01

    What is an adequate education and how much does it cost? In 1989, Kentucky's State Supreme Court found the entire system of education unconstitutional--"all of its parts and parcels". The Court called for all children to have access to an adequate education, one that is uniform and has as its goal the development of seven capacities, including:…

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

    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. 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)...

  15. 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 Veterinarian and Adequate Veterinary Care §...

  16. 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

    ... SAFETY BOARD Safety Analysis Requirements for Defining Adequate Protection for the Public and the Workers... TO THE SECRETARY OF ENERGY Safety Analysis Requirements for Defining Adequate Protection for the... safety analysis, or DSA, is to be prepared for every DOE nuclear facility. This DSA, once approved by...

  17. 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...

  18. 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...

  19. 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...

  20. Bovine hemoglobin as the sole source of dietary iron does not support adequate iron status in copper-adequate or copper-deficient rats

    Technology Transfer Automated Retrieval System (TEKTRAN)

    This experiment was designed to determine whether hemoglobin as the sole source of dietary iron (Fe) could sustain normal Fe status in growing rats. Because adequate copper (Cu) status is required for efficient Fe absorption in the rat, we also determined the effects of Cu deficiency on Fe status of...

  1. 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

  2. 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

    ... 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...

  3. 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

  4. 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

  5. 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.

  6. Optimizing clinical trial design for multiple system atrophy: lessons from the rifampicin study.

    PubMed

    Singer, Wolfgang; Low, Phillip A

    2015-02-01

    Multiple system atrophy (MSA) is a fatal neurodegenerative disorder characterized by autonomic failure and parkinsonism/ataxia; no treatment exists to slow disease progression. A number of factors have prevented or compromised trials targeting disease modification. A major hurdle has been uncertainty about the number of patients needed to achieve adequate power. Information based on natural history studies suggested such numbers to be so large that only international multi-center models seemed feasible. When designing the rifampicin trial in MSA we sought to identify and apply strategies that would improve power and reduce the number needed to treat to allow for an oligocenter approach. Strategies included: (1) inclusion/exclusion criteria designed to enroll patients with relatively early, actively progressing disease; (2) minimizing dropouts; (3) pre-defined interim analysis; and (4) approaches to reduce scoring variability. The model allowed for the number needed to treat to be only 50 patients per treatment arm. Ten selected sites managed to reach the recruitment goal within 12 months. The dropout rate was less than 10%, and the goal of enrolling patients with actively progressing disease was accomplished as reflected by the progression rate in the placebo group. Data from this unfortunately negative trial can now be effectively used to more realistically power future trials. A number of ways to further improve trial design and feasibility have been identified and include rigorous site selection and training, designated primary site investigators, improved error trapping, early site visits, remedial training, and future biomarkers for earlier diagnosis and tracking of disease progression. PMID:25763826

  7. Trial watch

    PubMed Central

    Vacchelli, Erika; Galluzzi, Lorenzo; Fridman, Wolf Hervé; Galon, Jerome; Sautès-Fridman, Catherine; Tartour, Eric; Kroemer, Guido

    2012-01-01

    The long-established notion that apoptosis would be immunologically silent, and hence it would go unnoticed by the immune system, if not tolerogenic, and hence it would actively suppress immune responses, has recently been revisited. In some instances, indeed, cancer cells undergo apoptosis while emitting a spatiotemporally-defined combination of signals that renders them capable of eliciting a long-term protective antitumor immune response. Importantly, only a few anticancer agents can stimulate such an immunogenic cell death. These include cyclophosphamide, doxorubicin and oxaliplatin, which are currently approved by FDA for the treatment of multiple hematologic and solid malignancies, as well as mitoxantrone, which is being used in cancer therapy and against multiple sclerosis. In this Trial Watch, we will review and discuss the progress of recent (initiated after January 2008) clinical trials evaluating the off-label use of cyclophosphamide, doxorubicin, oxaliplatin and mitoxantrone. PMID:22720239

  8. 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

  9. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology

    PubMed Central

    Azar, Marleine; Riehm, Kira E.; McKay, Dean; Thombs, Brett D.

    2015-01-01

    Background Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Methods Eligible RCTs were published in JCCP in 2013–2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Results Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). Conclusions The quality of published outcome analysis

  10. 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

  11. A method for determining adequate resistance form of complete cast crown preparations.

    PubMed

    Weed, R M; Baez, R J

    1984-09-01

    A diagram with various degrees of occlusal convergence, which takes into consideration the length and diameter of complete crown preparations, was designed as a guide to assist the dentist to obtain adequate resistance form. To test the validity of the diagram, five groups of complete cast crown stainless steel dies were prepared (3.5 mm long, occlusal convergence 10, 13, 16, 19, and 22 degrees). Gold copings were cast for each of the 50 preparations. Displacement force was applied to the casting perpendicularly to a simulated 30-degree cuspal incline until the casting was displaced. Castings were deformed at margins except for the 22-degree group. Castings from this group were displaced without deformation, and it was concluded that there was a lack of adequate resistance form as predicted by the diagram. The hypothesis that the diagram could be used to predict adequate or inadequate resistance form was confirmed by this study. PMID:6384470

  12. Comparison of four standards for determining adequate water intake of nursing home residents.

    PubMed

    Gaspar, Phyllis M

    2011-01-01

    Adequate hydration for nursing home residents is problematic. The purpose of this study was to compare four standards used to determine a recommended water intake among nursing home residents. Inconsistencies in the amount of water intake recommended based on the standards compared were identified. The standard based on height and weight provides the most individualized recommendation. An individualized recommendation would facilitate goal setting for the care plan of each older person and assist in the prevention of dehydration. It is essential that a cost-effective and clinically feasible approach to determine adequate water intake be determined for this population to prevent the adverse outcomes associated with dehydration. PMID:21469538

  13. Women's involvement in clinical trials: historical perspective and future implications.

    PubMed

    Liu, Katherine A; Mager, Natalie A Dipietro

    2016-01-01

    The importance of considering the differences between the male and female sex in clinical decision-making is crucial. However, it has been acknowledged in recent decades that clinical trials have not always adequately enrolled women or analyzed sex-specific differences in the data. As these deficiencies have hindered the progress of understanding women's response to medications, agencies in the United States have worked towards the inclusion of women in clinical trials and appropriate analysis of sex-specific data from clinical trials. This review outlines the history and progress of women's inclusion in clinical trials for prescription drugs and presents considerations for researchers, clinicians, and academicians on this issue. PMID:27011778

  14. 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. PMID:22565342

  15. 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

  16. Trial watch

    PubMed Central

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

    2012-01-01

    Toll-like receptors (TLRs) have first been characterized for their capacity to detect conserved microbial components like lipopolysaccharide (LPS) and double-stranded RNA, resulting in the elicitation of potent (innate) immune responses against invading pathogens. More recently, TLRs have also been shown to promote the activation of the cognate immune system against cancer cells. Today, only three TLR agonists are approved by FDA for use in humans: the bacillus Calmette-Guérin (BCG), monophosphoryl lipid A (MPL) and imiquimod. BCG (an attenuated strain of Mycobacterium bovis) is mainly used as a vaccine against tuberculosis, but also for the immunotherapy of in situ bladder carcinoma. MPL (derived from the LPS of Salmonella minnesota) is included in the formulation of Cervarix®, a vaccine against human papillomavirus-16 and -18. Imiquimod (a synthetic imidazoquinoline) is routinely employed for actinic keratosis, superficial basal cell carcinoma, and external genital warts (condylomata acuminata). In this Trial Watch, we will summarize the results of recently completed clinical trials and discuss the progress of ongoing studies that have evaluated/are evaluating FDA-approved TLR agonists as off-label medications for cancer therapy. PMID:23162757

  17. 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

  18. 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

  19. 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…

  20. 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. PMID:16315443

  1. Calculating and Reducing Errors Associated with the Evaluation of Adequate Yearly Progress.

    ERIC Educational Resources Information Center

    Hill, Richard

    In the Spring, 1996, issue of "CRESST Line," E. Baker and R. Linn commented that, in efforts to measure the progress of schools, "the fluctuations due to differences in the students themselves could conceal differences in instructional effects." This is particularly true in the context of the evaluation of adequate yearly progress required by…

  2. 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…

  3. 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...

  4. 75 FR 5893 - Suspension of Community Eligibility for Failure To Maintain Adequate Floodplain Management...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-05

    ... FR 51735. Executive Order 13132, Federalism. This rule involves no policies that have ] federalism....C. 4001 et seq., Reorganization Plan No. 3 of 1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR... To Maintain Adequate Floodplain Management Regulations AGENCY: Federal Emergency Management...

  5. 26 CFR 1.467-2 - Rent accrual for section 467 rental agreements without adequate interest.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... provide for a variable rate of interest. For purposes of the adequate interest test under paragraph (b)(1) of this section, if a section 467 rental agreement provides for variable interest, the rental... date as the issue date) for the variable rates called for by the rental agreement. For purposes of...

  6. The Unequal Effect of Adequate Yearly Progress: Evidence from School Visits

    ERIC Educational Resources Information Center

    Brown, Abigail B.; Clift, Jack W.

    2010-01-01

    The authors report insights, based on annual site visits to elementary and middle schools in three states from 2004 to 2006, into the incentive effect of the No Child Left Behind Act's requirement that increasing percentages of students make Adequate Yearly Progress (AYP) in every public school. They develop a framework, drawing on the physics…

  7. 9 CFR 2.33 - Attending veterinarian and adequate veterinary care.

    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. 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...

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

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Attending veterinarian and adequate 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...

  9. 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 failure to…

  10. A Model for Touch Technique and Computation of Adequate Cane Length.

    ERIC Educational Resources Information Center

    Plain-Switzer, Karen

    1993-01-01

    This article presents a model for the motion of a long-cane executing the touch technique and presents formulas for the projected length of a cane adequate to protect an individual with blindness against wall-type and pole-type hazards. The paper concludes that the long-cane should reach from the floor to the user's armpit. (JDD)

  11. 9 CFR 2.33 - Attending veterinarian and adequate veterinary care.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... animal health, behavior, and well-being is conveyed to the attending veterinarian; (4) Guidance to... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Attending veterinarian and adequate veterinary care. 2.33 Section 2.33 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION...

  12. 9 CFR 2.40 - Attending veterinarian and adequate veterinary care (dealers and exhibitors).

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... on problems of animal health, behavior, and well-being is conveyed to the attending veterinarian; (4... 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...

  13. 9 CFR 2.40 - Attending veterinarian and adequate veterinary care (dealers and exhibitors).

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... on problems of animal health, behavior, and well-being is conveyed to the attending veterinarian; (4... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Attending veterinarian and adequate veterinary care (dealers and exhibitors). 2.40 Section 2.40 Animals and Animal Products ANIMAL AND...

  14. 9 CFR 2.40 - Attending veterinarian and adequate veterinary care (dealers and exhibitors).

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... on problems of animal health, behavior, and well-being is conveyed to the attending veterinarian; (4... 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...

  15. 9 CFR 2.33 - Attending veterinarian and adequate veterinary care.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... animal health, behavior, and well-being is conveyed to the attending veterinarian; (4) Guidance to... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Attending veterinarian and adequate veterinary care. 2.33 Section 2.33 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION...

  16. 9 CFR 2.40 - Attending veterinarian and adequate veterinary care (dealers and exhibitors).

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... on problems of animal health, behavior, and well-being is conveyed to the attending veterinarian; (4... 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...

  17. Special or Not so Special: Special Education Background Experiences of Principals and Adequate Yearly Progress

    ERIC Educational Resources Information Center

    Wilcox, Jennifer E.

    2011-01-01

    This mixed-methods study researched the special education background experience of principals and the effect on students in the subgroup of Students with Disabilities in making Adequate Yearly Progress (AYP). In the state of Ohio, schools and districts are expected to make AYP as a whole and additionally make AYP for each subgroup (various…

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

    ERIC Educational Resources Information Center

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

    2015-01-01

    Separate mixed model analyses of variance 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 = 1,203). Multiple regressions examined whether accuracy in text consistency judgments uniquely accounted for variance in…

  19. 42 CFR 438.207 - Assurances of adequate capacity and services.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... with the State's requirements for availability of services, as set forth in § 438.206. (e) CMS' right... HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS MANAGED CARE Quality Assessment and Performance... 42 Public Health 4 2010-10-01 2010-10-01 false Assurances of adequate capacity and services....

  20. 42 CFR 438.207 - Assurances of adequate capacity and services.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... requirements: (1) Offers an appropriate range of preventive, primary care, and specialty services that is adequate for the anticipated number of enrollees for the service area. (2) Maintains a network of providers... enrollment in its service area in accordance with the State's standards for access to care under this...

  1. 42 CFR 438.207 - Assurances of adequate capacity and services.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... requirements: (1) Offers an appropriate range of preventive, primary care, and specialty services that is adequate for the anticipated number of enrollees for the service area. (2) Maintains a network of providers... enrollment in its service area in accordance with the State's standards for access to care under this...

  2. 42 CFR 438.207 - Assurances of adequate capacity and services.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... requirements: (1) Offers an appropriate range of preventive, primary care, and specialty services that is adequate for the anticipated number of enrollees for the service area. (2) Maintains a network of providers... enrollment in its service area in accordance with the State's standards for access to care under this...

  3. 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.

  4. Final 2004 Report on Adequate Yearly Progress in the Montgomery County Public Schools

    ERIC Educational Resources Information Center

    Stevenson, Jose W.

    2005-01-01

    The vast majority of Montgomery County public schools made sufficient progress on state testing and accountability standards in 2004 to comply with the adequate yearly progress (AYP) requirements under the "No Child Left Behind (NCLB) Act of 2001." Information released by the Maryland State Department of Education (MSDE) in October 2004 shows that…

  5. 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...

  6. 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...

  7. Estimates of Adequate School Spending by State Based on National Average Service Levels.

    ERIC Educational Resources Information Center

    Miner, Jerry

    1983-01-01

    Proposes a method for estimating expenditures per student needed to provide educational adequacy in each state. Illustrates the method using U.S., Arkansas, New York, Texas, and Washington State data, covering instruction, special needs, operations and maintenance, administration, and other costs. Estimates ratios of "adequate" to actual spending…

  8. Leadership Style and Adequate Yearly Progress: A Correlational Study of Effective Principal Leadership

    ERIC Educational Resources Information Center

    Leapley-Portscheller, Claudia Iris

    2008-01-01

    Principals are responsible for leading efforts to reach increasingly higher levels of student academic proficiency in schools associated with adequate yearly progress (AYP) requirements. The purpose of this quantitative, correlational study was to identify the degree to which perceptions of principal transformational, transactional, and…

  9. Percentage of Adults with High Cholesterol Whose LDL Cholesterol Levels Are Adequately Controlled

    MedlinePlus

    ... of Adults with High Cholesterol Whose LDL Cholesterol Levels are Adequately Controlled High cholesterol can double a ... with High Cholesterol that is Controlled by Education Level 8k4c-k22f Download these data » Click on legends ...

  10. 42 CFR 413.24 - Adequate cost data and cost finding.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false Adequate cost data and cost finding. 413.24 Section 413.24 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR END-STAGE RENAL DISEASE SERVICES; OPTIONAL PROSPECTIVELY...

  11. Principals' Perceptions of Effective Strategies in Meeting Adequate Yearly Progress in Special Education

    ERIC Educational Resources Information Center

    Meyer, Jadie K.

    2012-01-01

    The purpose of this study was to examine the perceptions of principals who have met Adequate Yearly Progress (AYP) with the special education subgroup. This was a qualitative study, utilizing interviews to answer the research questions. The first three research questions analyzed the areas of assessment, building-level leadership, and curriculum…

  12. 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 ...

  13. 75 FR 74022 - Safety Analysis Requirements for Defining Adequate Protection for the Public and the Workers

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-30

    ... November 15, 2010 (75 FR 69648). The corrected text of the recommendation approved by the Board is below... or telephone number (202) 694-7000. Correction: In the Federal Register of November 15, 2010 (75 FR... SAFETY BOARD Safety Analysis Requirements for Defining Adequate Protection for the Public and the...

  14. Evaluating Rural Progress in Mathematics Achievement: Threats to the Validity of "Adequate Yearly Progress"

    ERIC Educational Resources Information Center

    Lee, Jaekyung

    2003-01-01

    This article examines major threats to the validity of Adequate Yearly Progress (AYP) in the context of rural schools. Although rural students and their schools made significant academic progress in the past on national and state assessments, the current goal of AYP turns out to be highly unrealistic for them unless states set far lower…

  15. 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 regulated by another Federal agency. 152.20 Section 152.20 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION...

  16. 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 regulated by another Federal agency. 152.20 Section 152.20 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION...

  17. 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 regulated by another Federal agency. 152.20 Section 152.20 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION...

  18. What Is the Cost of an Adequate Vermont High School Education?

    ERIC Educational Resources Information Center

    Rucker, Frank D.

    2010-01-01

    Access to an adequate education has been widely considered an undeniable right since Chief Justice Warren stated in his landmark decision that "Today, education is perhaps the most important function of state and local governments...it is doubtful that any child may reasonably be expected to succeed in life if he is denied the opportunity of an…

  19. Applications of population data analysis in on-farm dairy trials.

    PubMed

    Engstrom, M; Sanchez, W; Stone, W; St-Pierre, N R

    2010-04-01

    With appropriate management controls and statistical designs, on-farm trials are an increasingly valuable research tool. On-farm trials can speed up technology adoption, particularly with those studies requiring large numbers of animals. Useful designs include longitudinal (pen vs. pen) trials, in which pen is the experimental unit, and crossover or switchback designs, in which treatments are imposed on a schedule over 1 or more experimental groups. A paired-herd design has been used, in which herds are the experimental units in a crossover trial. Others have published similar studies, including a multisite crossover design that used 35 dairy farms to compare milk responses with a protein source by using individual cow records to evaluate differences in milk production. Recently, statistical process control (SPC) techniques have been used to evaluate management changes by using repeated measures on the farm. Although a drawback to SPC may be the lack of traditional statistics to test differences (i.e., the lack of a control group), standard run rules are used to demonstrate with statistical certainty that a process or variable has changed, or to characterize a seasonal change. With SPC, the inference is limited to the herd or group of animals being monitored. Meta-analysis techniques are powerful tools used to combine results from many similar trials in which the response of interest is either small (i.e., continuous variables) or of low frequency (i.e., discrete variables). Meta-analysis can be used to segment a database so as to validate and compare trial methods or to investigate publication bias. Additional design concerns for reproduction studies include the need for adequate numbers of observations and planning for the lag time between an experimental treatment and response measurement (e.g., confirmation of pregnancy). PMID:19820048

  20. Randomized in vivo trial evaluating plaque inhibition benefits of an advanced stannous-containing sodium fluoride dentifrice used in conjunction with power brush technology

    PubMed Central

    Bellamy, PG; Boulding, A; Farmer, S; Day, TN; Barker, ML; Harris, R; Mussett, AJ

    2014-01-01

    Objective To compare the plaque inhibition efficacy of a novel stannous-containing sodium fluoride test dentifrice to a standard anticavity negative control dentifrice, when both were used in conjunction with an advanced oscillating–rotating (O/R) power toothbrush. Methods This was a randomized, two-treatment, three-period, double-blind crossover study conducted in a population using an O/R power brush. Subjects brushed twice per day with their assigned dentifrice during the three-treatment periods, each lasting for 17 consecutive days. Each period was separated by a 4-day washout period during which subjects continued to use their O/R power toothbrush. Plaque levels were assessed and averaged amongst three assessments taken on days 15, 16 and 17 at the end of each treatment period using digital plaque imaging analysis. Assessments were carried out on the facial anterior tooth surfaces in the morning before brushing (A.M. prebrush) following whole-mouth brushing (30 s per quadrant) with the assigned dentifrice (A.M. post-brush) and in the afternoon (P.M.). Results Twenty-seven subjects were randomized and completed the study. During the 17-day usage period, the stannous-containing test NaF dentifrice demonstrated a statistically significant lower mean plaque area versus the negative control dentifrice at each assessment timepoint; overnight A.M. prebrush was 33.8% lower (P < 0.0001), A.M. post-brush was 21.8% lower (P < 0.01), and P.M. was 29.2% lower (P < 0.0001). Conclusion A population of O/R power toothbrush users had significantly less plaque coverage for all three measurements when using a stannous-containing NaF dentifrice than when using a negative control (fluoride) dentifrice. PMID:23844867

  1. How Do Clinical Trials Work?

    MedlinePlus

    ... Trials Clinical Trial Websites How Do Clinical Trials Work? If you take part in a clinical trial, ... kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...

  2. Trial Watch

    PubMed Central

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

    2013-01-01

    Adoptive cell transfer (ACT) represents a prominent form of immunotherapy against malignant diseases. ACT is conceptually distinct from dendritic cell-based approaches (which de facto constitute cellular vaccines) and allogeneic transplantation (which can be employed for the therapy of hematopoietic tumors) as it involves the isolation of autologous lymphocytes exhibiting antitumor activity, their expansion/activation ex vivo and their reintroduction into the patient. Re-infusion is most often performed in the context of lymphodepleting regimens (to minimize immunosuppression by host cells) and combined with immunostimulatory interventions, such as the administration of Toll-like receptor agonists. Autologous cells that are suitable for ACT protocols can be isolated from tumor-infiltrating lymphocytes or generated by engineering their circulating counterparts for the expression of transgenic tumor-specific T-cell receptors. Importantly, lymphocytes can be genetically modified prior to re-infusion for increasing their persistence in vivo, boosting antitumor responses and minimizing side effects. Moreover, recent data indicate that exhausted antitumor T lymphocytes may be rejuvenated in vitro by exposing them to specific cytokine cocktails, a strategy that might considerably improve the clinical success of ACT. Following up the Trial Watch that we published on this topic in the third issue of OncoImmunology (May 2012), here we summarize the latest developments in ACT-related 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 this form of cellular immunotherapy. PMID:23762803

  3. Trial watch

    PubMed Central

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

    2013-01-01

    Oncolytic virotherapy is emerging as a promising approach for the treatment of several neoplasms. The term “oncolytic viruses” is generally employed to indicate naturally occurring or genetically engineered attenuated viral particles that cause the demise of malignant cells while sparing their non-transformed counterparts. From a conceptual standpoint, oncolytic viruses differ from so-called “oncotropic viruses” in that only the former are able to kill cancer cells, even though both display a preferential tropism for malignant tissues. Of note, such a specificity can originate at several different steps of the viral cycle, including the entry of virions (transductional specificity) as well as their intracellular survival and replication (post-transcriptional and transcriptional specificity). During the past two decades, a large array of replication-competent and replication-incompetent oncolytic viruses has been developed and engineered to express gene products that would specifically promote the death of infected (cancer) cells. However, contrarily to long-standing beliefs, the antineoplastic activity of oncolytic viruses is not a mere consequence of the cytopathic effect, i.e., the lethal outcome of an intense, productive viral infection, but rather involves the elicitation of an antitumor immune response. In line with this notion, oncolytic viruses genetically modified to drive the local production of immunostimulatory cytokines exert more robust therapeutic effects than their non-engineered counterparts. Moreover, the efficacy of oncolytic virotherapy is significantly improved by some extent of initial immunosuppression (facilitating viral replication and spread) followed by the administration of immunostimulatory molecules (boosting antitumor immune responses). In this Trial Watch, we will discuss the results of recent clinical trials that have evaluated/are evaluating the safety and antineoplastic potential of oncolytic virotherapy. PMID:23894720

  4. 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

  5. Voluntary muscle activation improves with power training and is associated with changes in gait speed in mobility-limited older adults - A randomized controlled trial.

    PubMed

    Hvid, Lars G; Strotmeyer, Elsa S; Skjødt, Mathias; Magnussen, Line V; Andersen, Marianne; Caserotti, Paolo

    2016-07-01

    Incomplete voluntary muscle activation may contribute to impaired muscle mechanical function and physical function in older adults. Exercise interventions have been shown to increase voluntary muscle activation, although the evidence is sparse for mobility-limited older adults, particularly in association with physical function. This study examined the effects of 12weeks of power training on outcomes of voluntary muscle activation and gait speed in mobility-limited older adults from the Healthy Ageing Network of Competence (HANC) study. We included 37 older men and women with a usual gait speed of <0.9m/s in the per-protocol analysis: n=16 in the training group (TG: 12weeks of progressive high-load power training, 2 sessions per week; age: 82.3±1.3years, 56% women) and n=21 in the control group (CG: no interventions; age: 81.6±1.1years, 67% women). Knee extensor muscle thickness (ultrasonography), strength (isokinetic dynamometry), voluntary activation (interpolated twitch technique), and gait speed (2-min maximal walking test) were assessed at baseline and post-intervention. At baseline, TG and CG were comparable for all measures. Post-intervention, significant between-group changes (TG vs. CG; p<0.05) were observed for voluntary muscle activation (+6.2%), muscle strength (+13.4Nm), and gait speed (+0.12m/s), whereas the between-group change in muscle thickness was non-significant (+0.08cm). Improvements in voluntary muscle activation were associated with improvements in gait speed in TG (r=0.67, p<0.05). Importantly, voluntary muscle activation is improved in mobility-limited older adults following 12-weeks of progressive power training, and is associated with improved maximal gait speed. Incomplete voluntary muscle activation should be considered one of the key mechanisms influencing muscle mechanical function and gait speed in older adults. PMID:27090485

  6. 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. PMID:15260028

  7. Vitamin D associates with improved quality of life in participants with irritable bowel syndrome: outcomes from a pilot trial

    PubMed Central

    Tazzyman, Simon; Richards, Nicholas; Trueman, Andrew R; Evans, Amy L; Grant, Vicky A; Garaiova, Iveta; Plummer, Sue F; Williams, Elizabeth A; Corfe, Bernard M

    2015-01-01

    Background Vitamin D deficiency has been associated or implicated with the pathophysiology of the gastrointestinal conditions inflammatory bowel disease and colorectal cancer, as well as with depression. No trials or epidemiology studies to date have investigated a link with irritable bowel syndrome (IBS). A single case report has suggested a benefit in IBS of vitamin D supplementation. We hypothesised that IBS participants with vitamin D insufficiency would benefit from repletion in terms of their IBS symptoms. We undertook a pilot trial to provide data to support a power calculation and to justify a full trial. Methods This was a randomised, double blinded, three-arm parallel design trial of vitamin D, placebo or a combination of vitamin D and probiotics. Participants were further stratified according to whether they were vitamin D replete or insufficient. Vitamin D status was determined by blood test at baseline and exit; IBS symptoms were assessed by validated questionnaire; dietary intakes were assessed by food frequency questionnaire. Results A significant proportion of the IBS population were vitamin D deficient, such that the replete stratum could not be adequately recruited. There was a significant association in the baseline data between circulating vitamin D level and quality of life (“How much has IBS affected your life?”). Supplementation significantly improved vitamin D level versus placebo. IBS symptoms were not significantly improved in this pilot, although a power calculation was enabled from the intervention data. Conclusions The IBS population exhibits significant levels of vitamin D insufficiency and would benefit from screening and possible supplementation. The impact of IBS on quality of life may be reduced by vitamin D level. Future trials should have a sample size of over 97. Trial registration number: ICTRN 6116003917. PMID:26719813

  8. Stroke Trials Registry

    MedlinePlus

    ... Trials News About Neurology Image Library Search The Internet Stroke Center Trials Registry Clinical Trials Interventions Conditions ... UT Southwestern Medical Center. Copyright © 1997-2011 - The Internet Stroke Center. All rights reserved. The information contained ...

  9. A novel strategy to overcome resistance in stent placement at lesion site after adequate predilatation.

    PubMed

    Jain, D; Tolg, R; Katus, H A; Richardt, G

    2000-12-01

    Resistance was encountered in passing a 3 x 18 mm stent across a lesion in the proximal left anterior descending coronary artery. Successive changes in stent with repeated balloon dilatations did not succeed. Finally, a 9 mm stent was passed across the lesion and deployed at the site of maximal resistance. The 18 mm stent was then placed through this stent. A novel strategy to overcome resistance in the stent passage through the lesion after an adequate balloon predilatation is reported. PMID:11103034

  10. 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…

  11. A blast without power - cell death induced by the tuberculosis-necrotizing toxin fails to elicit adequate immune responses.

    PubMed

    Maueröder, C; Chaurio, R A; Dumych, T; Podolska, M; Lootsik, M D; Culemann, S; Friedrich, R P; Bilyy, R; Alexiou, C; Schett, G; Berens, C; Herrmann, M; Munoz, L E

    2016-06-01

    In this study, we deploy a doxycycline-dependent suicide switch integrated in a tumor challenge model. With this experimental setup, we characterized the immunological consequences of cells dying by four distinct cell death stimuli in vivo. We observed that apoptotic cell death induced by expression of the truncated form of BH3 interacting-domain death agonist (tBid) and a constitutively active form of caspase 3 (revC3), respectively, showed higher immunogenicity than cell death induced by expression of the tuberculosis-necrotizing toxin (TNT). Our data indicate that the early release of ATP induces the silent clearance of dying cells, whereas the simultaneous presence of 'find me' signals and danger-associated molecular patterns (DAMPs) promotes inflammatory reactions and increased immunogenicity. This proposed model is supported by findings showing that the production and release of high concentrations of IL-27 by bone-marrow-derived macrophages (BMDM) is limited to BMDM exposed to those forms of death that simultaneously released ATP and the DAMPs heat-shock protein 90 (HSP90) and high-mobility group box-1 protein (HMGB1). These results demonstrate that the tissue microenvironment generated by dying cells may determine the subsequent immune response. PMID:26943324

  12. Legislation for trial registration and data transparency.

    PubMed

    Bian, Zhao-Xiang; Wu, Tai-Xiang

    2010-01-01

    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. PMID:20504337

  13. 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. PMID:23761295

  14. 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

  15. Self-esteem, social support, and satisfaction differences in women with adequate and inadequate prenatal care.

    PubMed

    Higgins, P; Murray, M L; Williams, E M

    1994-03-01

    This descriptive, retrospective study examined levels of self-esteem, social support, and satisfaction with prenatal care in 193 low-risk postpartal women who obtained adequate and inadequate care. The participants were drawn from a regional medical center and university teaching hospital in New Mexico. A demographic questionnaire, the Coopersmith self-esteem inventory, the personal resource questionnaire part 2, and the prenatal care satisfaction inventory were used for data collection. Significant differences were found in the level of education, income, insurance, and ethnicity between women who received adequate prenatal care and those who received inadequate care. Women who were likely to seek either adequate or inadequate prenatal care were those whose total family income was $10,000 to $19,999 per year and high school graduates. Statistically significant differences were found in self-esteem, social support, and satisfaction between the two groups of women. Strategies to enhance self-esteem and social support have to be developed to reach women at risk for receiving inadequate prenatal care. PMID:8155221

  16. Physiotherapy informed by Acceptance and Commitment Therapy (PACT): protocol for a randomised controlled trial of PACT versus usual physiotherapy care for adults with chronic low back pain

    PubMed Central

    Godfrey, Emma; Galea Holmes, Melissa; Wileman, Vari; McCracken, Lance; Moss-Morris, Rona; Pallet, John; Sanders, Duncan; Barcellona, Massimo; Critchley, Duncan

    2016-01-01

    Introduction Chronic low back pain (CLBP) is a common condition and source of significant suffering, disability and healthcare costs. Current physiotherapy treatment is moderately effective. Combining theory-based psychological methods with physiotherapy could improve outcomes for people with CLBP. The primary aim of this randomised controlled trial (RCT) is to evaluate the efficacy of Physiotherapy informed by Acceptance and Commitment Therapy (PACT) on functioning in patients with CLBP. Methods and analysis The PACT trial is a two-armed, parallel-group, multicentre RCT to assess the efficacy of PACT in comparison with usual physiotherapy care (UC). 240 patients referred to physiotherapy with CLBP will be recruited from three National Health Service (NHS) hospitals trusts. Inclusion criteria are: age ≥18 years, CLBP ≥12-week duration, scoring ≥3 points on the Roland-Morris Disability Questionnaire (RMDQ) and adequate understanding of spoken and written English to participate. Patients will be randomised to PACT or UC (120 per arm stratified by centre) by an independent randomisation service and followed up at 3 and 12 months post randomisation. The sample size of 240 will provide adequate power to detect a standardised mean difference of 0.40 in the primary outcome (RMDQ; 5% significance, 80% power) assuming attrition of 20%. Analysis will be by intention to treat conducted by the trial statistician, blind to treatment group, following a prespecified analysis plan. Estimates of treatment effect at the follow-up assessments will use an intention-to-treat framework, implemented using a linear mixed-effects model. Ethics and dissemination This trial has full ethical approval (14/SC/0277). It will be disseminated via peer-reviewed publications and conference presentations. The results will enable clinicians, patients and health service managers to make informed decisions regarding the efficacy of PACT for patients with CLBP. Trial registration number ISRCTN

  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

    2015-01-01

    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. PMID:26171983

  18. 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

  19. Trial Watch:

    PubMed Central

    Pol, Jonathan; Bloy, Norma; Obrist, Florine; Eggermont, Alexander; Galon, Jérôme; Cremer, Isabelle; Erbs, Philippe; Limacher, Jean-Marc; Preville, Xavier; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

    2014-01-01

    Oncolytic viruses are natural or genetically modified viral species that selectively infect and kill neoplastic cells. Such an innate or exogenously conferred specificity has generated considerable interest around the possibility to employ oncolytic viruses as highly targeted agents that would mediate cancer cell-autonomous anticancer effects. Accumulating evidence, however, suggests that the therapeutic potential of oncolytic virotherapy is not a simple consequence of the cytopathic effect, but strongly relies on the induction of an endogenous immune response against transformed cells. In line with this notion, superior anticancer effects are being observed when oncolytic viruses are engineered to express (or co-administered with) immunostimulatory molecules. Although multiple studies have shown that oncolytic viruses are well tolerated by cancer patients, the full-blown therapeutic potential of oncolytic virotherapy, especially when implemented in the absence of immunostimulatory interventions, remains unclear. Here, we cover the latest advances in this active area of translational investigation, summarizing high-impact studies that have been published during the last 12 months and discussing clinical trials that have been initiated in the same period to assess the therapeutic potential of oncolytic virotherapy in oncological indications. PMID:25097804

  20. 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

  1. 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

  2. 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

  3. Lessons learned from radiation oncology clinical trials.

    PubMed

    Liu, Fei-Fei; Okunieff, Paul; Bernhard, Eric J; Stone, Helen B; Yoo, Stephen; Coleman, C Norman; Vikram, Bhadrasain; Brown, Martin; Buatti, John; Guha, Chandan

    2013-11-15

    A workshop entitled "Lessons Learned from Radiation Oncology Trials" was held on December 7-8, 2011, in Bethesda, MD, to present and discuss some of the recently conducted radiation oncology clinical trials with a focus on those that failed to refute the null hypothesis. The objectives of this workshop were to summarize and examine the questions that these trials provoked, to assess the quality and limitations of the preclinical data that supported the hypotheses underlying these trials, and to consider possible solutions to these challenges for the design of future clinical trials. Several themes emerged from the discussions: (i) opportunities to learn from null-hypothesis trials through tissue and imaging studies; (ii) value of preclinical data supporting the design of combinatorial therapies; (iii) significance of validated biomarkers; (iv) necessity of quality assurance in radiotherapy delivery; (v) conduct of sufficiently powered studies to address the central hypotheses; and (vi) importance of publishing results of the trials regardless of the outcome. The fact that well-designed hypothesis-driven clinical trials produce null or negative results is expected given the limitations of trial design and complexities of cancer biology. It is important to understand the reasons underlying such null results, however, to effectively merge the technologic innovations with the rapidly evolving biology for maximal patient benefit through the design of future clinical trials. PMID:24043463

  4. Trial Watch

    PubMed Central

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

    2013-01-01

    Radiotherapy has extensively been employed as a curative or palliative intervention against cancer throughout the last century, with a varying degree of success. For a long time, the antineoplastic activity of X- and γ-rays was entirely ascribed to their capacity of damaging macromolecules, in particular DNA, and hence triggering the (apoptotic) demise of malignant cells. However, accumulating evidence indicates that (at least part of) the clinical potential of radiotherapy stems from cancer cell-extrinsic mechanisms, including the normalization of tumor vasculature as well as short- and long-range bystander effects. Local bystander effects involve either the direct transmission of lethal signals between cells connected by gap junctions or the production of diffusible cytotoxic mediators, including reactive oxygen species, nitric oxide and cytokines. Conversely, long-range bystander effects, also known as out-of-field or abscopal effects, presumably reflect the elicitation of tumor-specific adaptive immune responses. Ionizing rays have indeed been shown to promote the immunogenic demise of malignant cells, a process that relies on the spatiotemporally defined emanation of specific damage-associated molecular patterns (DAMPs). Thus, irradiation reportedly improves the clinical efficacy of other treatment modalities such as surgery (both in neo-adjuvant and adjuvant settings) or chemotherapy. Moreover, at least under some circumstances, radiotherapy may potentiate anticancer immune responses as elicited by various immunotherapeutic agents, including (but presumably not limited to) immunomodulatory monoclonal antibodies, cancer-specific vaccines, dendritic cell-based interventions and Toll-like receptor agonists. Here, we review the rationale of using radiotherapy, alone or combined with immunomodulatory agents, as a means to elicit or boost anticancer immune responses, and present recent clinical trials investigating the therapeutic potential of this approach in

  5. 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

  6. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable

    PubMed Central

    Julious, Steven A; Cooper, Cindy L; Campbell, Michael J

    2015-01-01

    Sample size justification is an important consideration when planning a clinical trial, not only for the main trial but also for any preliminary pilot trial. When the outcome is a continuous variable, the sample size calculation requires an accurate estimate of the standard deviation of the outcome measure. A pilot trial can be used to get an estimate of the standard deviation, which could then be used to anticipate what may be observed in the main trial. However, an important consideration is that pilot trials often estimate the standard deviation parameter imprecisely. This paper looks at how we can choose an external pilot trial sample size in order to minimise the sample size of the overall clinical trial programme, that is, the pilot and the main trial together. We produce a method of calculating the optimal solution to the required pilot trial sample size when the standardised effect size for the main trial is known. However, as it may not be possible to know the standardised effect size to be used prior to the pilot trial, approximate rules are also presented. For a main trial designed with 90% power and two-sided 5% significance, we recommend pilot trial sample sizes per treatment arm of 75, 25, 15 and 10 for standardised effect sizes that are extra small (≤0.1), small (0.2), medium (0.5) or large (0.8), respectively. PMID:26092476

  7. 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

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

    PubMed

    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

  9. Chronic leg ulcer: does a patient always get a correct diagnosis and adequate treatment?

    PubMed

    Mooij, Michael C; Huisman, Laurens C

    2016-03-01

    Patients with chronic leg ulcers have severely impaired quality of life and account for a high percentage of annual healthcare costs. To establish the cause of a chronic leg ulcer, referral to a center with a multidisciplinary team of professionals is often necessary. Treating the underlying cause diminishes healing time and reduces costs. In venous leg ulcers adequate compression therapy is still a problem. It can be improved by training the professionals with pressure measuring devices. A perfect fitting of elastic stockings is important to prevent venous leg ulcer recurrence. In most cases, custom-made stockings are the best choice for this purpose. PMID:26916772

  10. Determining Adequate Margins in Head and Neck Cancers: Practice and Continued Challenges.

    PubMed

    Williams, Michelle D

    2016-09-01

    Margin assessment remains a critical component of oncologic care for head and neck cancer patients. As an integrated team, both surgeons and pathologists work together to assess margins in these complex patients. Differences in method of margin sampling can impact obtainable information and effect outcomes. Additionally, what distance is an "adequate or clear" margin for patient care continues to be debated. Ultimately, future studies and potentially secondary modalities to augment pathologic assessment of margin assessment (i.e., in situ imaging or molecular assessment) may enhance local control in head and neck cancer patients. PMID:27469263

  11. Family Structure Types and Adequate Utilization of Antenatal Care in Kenya.

    PubMed

    Owili, Patrick Opiyo; Muga, Miriam Adoyo; Chou, Yiing-Jenq; Hsu, Yi-Hsin Elsa; Huang, Nicole; Chien, Li-Yin

    2016-01-01

    Features of the health care delivery system may not be the only expounding factors of adequate utilization of antenatal care among women. Other social factors such as the family structure and its environment contribute toward pregnant women's utilization of antenatal care. An understanding of how women in different family structure types and social groups use basic maternal health services is important toward developing and implementing maternal health care policy in the post-Millennium Development Goal era, especially in the sub-Saharan Africa where maternal mortality still remains high. PMID:27214674

  12. Working group on the “adequate minimum” V=volcanic observatory

    USGS Publications Warehouse

    Tilling, R.I.

    1982-01-01

    A working group consisting of R. I. Tilling (United States, Chairman), M. Espendola (Mexico), E. Malavassi (Costa Rica), L. Villari (Italy), and J.P Viode (France) met on the island of Guadeloupe on February 20, 1981, to discuss informally the requirements for a "Minimum" volcano observatory, one which would have the essential monitoring equipment and staff to provide reliable information on the state of an active volcno. Given the premise that any monitoring of a volcano is better than none at all, the owrking group then proceeded to consider the concept of an "adequate minimum" observatory. 

  13. Mock Trials for Children.

    ERIC Educational Resources Information Center

    Hickey, M. Gail

    1990-01-01

    Demonstrates how role-playing in a mock trial situation allows children to view critically both sides of an issue and introduce them to trial procedure. Offers pre-trial activities, ways to teach students to see both sides of a situation, themes for mock trials, and supporting resources. (GG)

  14. Discrete Trials Teaching

    ERIC Educational Resources Information Center

    Ghezzi, Patrick M.

    2007-01-01

    The advantages of emphasizing discrete trials "teaching" over discrete trials "training" are presented first, followed by a discussion of discrete trials as a method of teaching that emerged historically--and as a matter of necessity for difficult learners such as those with autism--from discrete trials as a method for laboratory research. The…

  15. 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.

  16. 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

  17. Adequately-Sized Nanocarriers Allow Sustained Targeted Drug Delivery to Neointimal Lesions in Rat Arteries.

    PubMed

    Taniguchi, Ryosuke; Miura, Yutaka; Koyama, Hiroyuki; Chida, Tsukasa; Anraku, Yasutaka; Kishimura, Akihiro; Shigematsu, Kunihiro; Kataoka, Kazunori; Watanabe, Toshiaki

    2016-06-01

    In atherosclerotic lesions, the endothelial barrier against the bloodstream can become compromised, resulting in the exposure of the extracellular matrix (ECM) and intimal cells beneath. In theory, this allows adequately sized nanocarriers in circulation to infiltrate into the intimal lesion intravascularly. We sought to evaluate this possibility using rat carotid arteries with induced neointima. Cy5-labeled polyethylene glycol-conjugated polyion complex (PIC) micelles and vesicles, with diameters of 40, 100, or 200 nm (PICs-40, PICs-100, and PICs-200, respectively) were intravenously administered to rats after injury to the carotid artery using a balloon catheter. High accumulation and long retention of PICs-40 in the induced neointima was confirmed by in vivo imaging, while the accumulation of PICs-100 and PICs-200 was limited, indicating that the size of nanocarriers is a crucial factor for efficient delivery. Furthermore, epirubicin-incorporated polymeric micelles with a diameter similar to that of PICs-40 showed significant curative effects in rats with induced neointima, in terms of lesion size and cell number. Specific and effective drug delivery to pre-existing neointimal lesions was demonstrated with adequate size control of the nanocarriers. We consider that this nanocarrier-based drug delivery system could be utilized for the treatment of atherosclerosis. PMID:27183493

  18. Adequate Systemic Perfusion Maintained by a CentriMag during Acute Heart Failure

    PubMed Central

    Favaloro, Roberto R.; Bertolotti, Alejandro; Diez, Mirta; Favaloro, Liliana; Gomez, Carmen; Peradejordi, Margarita; Trentadue, Julio; Hellman, Lorena; Arzani, Yanina; Otero, Pilar Varela

    2008-01-01

    Mechanical circulatory support during severe acute heart failure presents options for myocardial recovery or cardiac replacement. Short-term circulatory support with the newest generation of magnetically levitated centrifugal-flow pumps affords several potential advantages. Herein, we present our experience with such a pump—the CentriMag® (Levitronix LLC; Waltham, Mass) centrifugal-flow ventricular assist device—in 4 critically ill patients who were in cardiogenic shock. From November 2007 through March 2008, 3 patients were supported after cardiac surgery, and 1 after chronic heart failure worsened. Two patients were bridged to heart transplantation, and 2 died during support. Perfusion during support was evaluated in terms of serum lactic acid levels and oxygenation values. In all of the patients, the CentriMag's pump flow was adequate, and continuous mechanical ventilation support was provided. Lactic acid levels substantially improved with CentriMag support and were maintained at near-normal levels throughout. At the same time, arterial pH, PO2, and carbon dioxide levels remained within acceptable ranges. No thromboembolic events or mechanical failures occurred. Our experience indicates that short-term use of the CentriMag ventricular assist device during acute heart failure can restore and adequately support circulation until recovery or until the application of definitive therapy. PMID:18941648

  19. 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.

  20. 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…

  1. A prospective, quantitative study of the natural history of facioscapulohumeral muscular dystrophy (FSHD): implications for therapeutic trials. The FSH-DY Group.

    PubMed

    1997-01-01

    Facioscapulohumeral muscular dystrophy (FSHD) is an autosomal-dominant disorder localized to 4q35. Neither the gene nor the gene product has been identified. There is presently no established treatment for FSHD. Prospective data on the natural history of this disorder are essential for the effective design of therapeutic trials. We systematically followed 81 well defined FSHD patients for up to 3 years using a standardized protocol that included manual muscle testing (MMT), maximum voluntary isometric contraction testing (MVICT), and functional testing. Muscle strength was strongly associated with measures of muscle mass, age at onset, and duration of disease. Decline in strength over time was slow but detectable with both MVICT and MMT. The magnitude of decline was not associated with either age, gender, age at onset, or duration of disease. This study establishes reliable and valid measures of disease state and progression for use as outcome variables in clinical trials in FSHD, and also provides guidelines for determining sample size and duration of follow-up. A two-armed clinical trial involving 160 patients per group and 1 year of follow-up would provide 80% power to detect complete arrest of the progression of the disease. Trials with fewer patients would thus have adequate power to detect only improvements in strength, unless follow-up duration were extended well beyond 1 year. PMID:9008491

  2. 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

  3. Significant excess of early deaths after prehospital ticagrelor: The ATLANTIC trial challenge.

    PubMed

    Serebruany, Victor; Cherepanov, Vasily; Dukhanin, Alexander

    2015-07-01

    The recently published Administration of Ticagrelor in the Cath Lab or in the Ambulance for New ST Elevation Myocardial Infarction to Open the Coronary Artery (ATLANTIC) trial concluded that prehospital administration of ticagrelor in patients with acute STEMI appeared to be safe but did not improve pre-PCI coronary reperfusion. The ATLANTIC data fully support the PLATO Angiographic Substudy denying early benefit of ticagrelor, and correspond well with lack of immediate clinical benefit including the early PCI "death paradox" in PLATO-USA patients. Finally, there were significantly (p=0.043) more deaths in early ticagrelor ATLANTIC arm (odds ratio 3.18 (1.02-9.90) challenging stent thrombosis reduction. Indeed, ATLANTIC represents an important step for our better understanding of ticagrelor, although the confirmation of the PLATO mortality wonder in an adequately powered PEGASUS (TIMI-54) to be reported in 2015 will be vital for ticagrelor future. PMID:25947272

  4. Do measures commonly used in body image research perform adequately with African American college women?

    PubMed

    Kashubeck-West, Susan; Coker, Angela D; Awad, Germine H; Stinson, Rebecca D; Bledman, Rashanta; Mintz, Laurie

    2013-07-01

    This study examines reliability and validity estimates for 3 widely used measures in body image research in a sample of African American college women (N = 278). Internal consistency estimates were adequate (α coefficients above .70) for all measures, and evidence of convergent and discriminant validity was found. Confirmatory factor analyses failed to replicate the hypothesized factor structures of these measures. Exploratory factor analyses indicated that 4 factors found for the Sociocultural Attitudes Toward Appearance Questionnaire were similar to the hypothesized subscales, with fewer items. The factors found for the Multidimensional Body-Self Relations Questionnaire-Appearance Scales and the Body Dissatisfaction subscale of the Eating Disorders Inventory-3 were not similar to the subscales developed by the scale authors. Validity and reliability evidence is discussed for the new factors. PMID:23731233

  5. Esmolol in a case of severe tetanus. Adequate haemodynamic control achieved despite markedly elevated catecholamine levels.

    PubMed

    Beards, S C; Lipman, J; Bothma, P A; Joynt, G M

    1994-03-01

    A patient with severe tetanus, who had a sympathetic crisis while sedated with 30 mg/h diazepam and 30 mg/h morphine, is described. Satisfactory control of the haemodynamic crisis was achieved with bolus doses of esmolol to a total of 180 mg. A disturbing finding was that although there was adequate control of the tachycardia and hypertension, arterial catecholamine levels remained markedly elevated. Adrenaline levels of 531 pg/ml (normal 10-110 pg/ml) and noradrenaline levels of 1,036 pg/ml (normal 100-500 pg/ml) were recorded when the patient had a systolic arterial pressure of 110 mmHg and a heart rate of 97/min. The implications of this finding are discussed. PMID:11218441

  6. Overcome of Carbon Catabolite Repression of Bioinsecticides Production by Sporeless Bacillus thuringiensis through Adequate Fermentation Technology.

    PubMed

    Ben Khedher, Saoussen; Jaoua, Samir; Zouari, Nabil

    2014-01-01

    The overcoming of catabolite repression, in bioinsecticides production by sporeless Bacillus thuringiensis strain S22 was investigated into fully controlled 3 L fermenter, using glucose based medium. When applying adequate oxygen profile throughout the fermentation period (75% oxygen saturation), it was possible to partially overcome the catabolite repression, normally occurring at high initial glucose concentrations (30 and 40 g/L glucose). Moreover, toxin production yield by sporeless strain S22 was markedly improved by the adoption of the fed-batch intermittent cultures technology. With 22.5 g/L glucose used into culture medium, toxin production was improved by about 36% when applying fed-batch culture compared to one batch. Consequently, the proposed fed-batch strategy was efficient for the overcome of the carbon catabolite repression. So, it was possible to overproduce insecticidal crystal proteins into highly concentrated medium. PMID:25309756

  7. Adequate bases of phase space master integrals for gg → h at NNLO and beyond

    NASA Astrophysics Data System (ADS)

    Höschele, Maik; Hoff, Jens; Ueda, Takahiro

    2014-09-01

    We study master integrals needed to compute the Higgs boson production cross section via gluon fusion in the infinite top quark mass limit, using a canonical form of differential equations for master integrals, recently identified by Henn, which makes their solution possible in a straightforward algebraic way. We apply the known criteria to derive such a suitable basis for all the phase space master integrals in afore mentioned process at next-to-next-to-leading order in QCD and demonstrate that the method is applicable to next-to-next-to-next-to-leading order as well by solving a non-planar topology. Furthermore, we discuss in great detail how to find an adequate basis using practical examples. Special emphasis is devoted to master integrals which are coupled by their differential equations.

  8. Rationale for the Prevention of Syncope Trial IV: Assessment of Midodrine

    PubMed Central

    Raj, Satish R; Faris, Peter D; McRae, Maureen; Sheldon, Robert S

    2012-01-01

    Background Vasovagal syncope is a common problem associated with a poor quality of life, which improves when the frequency of syncope is reduced. Effective pharmacological therapies for vasovagal syncope have been elusive. Midodrine is a pro-drug whose primary metabolite is an alpha-1 adrenoreceptor agonist. Small studies have suggested that it may be beneficial in syncope, but all have had significant methodological limitations. A placebo-controlled clinical trial of midodrine for the prevention of vasovagal syncope is needed. Structure of study The Prevention of Syncope Trial IV (POST 4) is a multicenter, international, randomized, placebo-controlled study of midodrine in the prevention of vasovagal syncope. The primary endpoint is the time to first recurrence of syncope. Patients will be randomized 1:1 to receive midodrine 10–30 mg/day or matching placebo, and followed for 1 year. Secondary endpoints include syncope frequency, presyncope, and quality of life. Primary analysis will be performed with an intention to treat approach, with a secondary on-treatment analysis. Power calculations A total sample size of 112, split equally between the two groups achieves 85% power to detect a 50% relative risk reduction when the event rates are 55% and 27.5% in the placebo and midodrine arms. Allowing for 20% dropout, we propose to enroll 140 patients. Registration POST 4 is registered with www.clinicaltrials.gov (NCT01456481). Implications This study will be the first adequately powered trial to determine whether midodrine is effective in preventing vasovagal syncope. If it is effective, then midodrine may become the first line pharmacological therapy for this condition. PMID:22610268

  9. 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.

  10. Are the Psychological Needs of Adolescent Survivors of Pediatric Cancer Adequately Identified and Treated?

    PubMed Central

    Kahalley, Lisa S.; Wilson, Stephanie J.; Tyc, Vida L.; Conklin, Heather M.; Hudson, Melissa M.; Wu, Shengjie; Xiong, Xiaoping; Stancel, Heather H.; Hinds, Pamela S.

    2012-01-01

    Objectives To describe the psychological needs of adolescent survivors of acute lymphoblastic leukemia (ALL) or brain tumor (BT), we examined: (a) the occurrence of cognitive, behavioral, and emotional concerns identified during a comprehensive psychological evaluation, and (b) the frequency of referrals for psychological follow-up services to address identified concerns. Methods Psychological concerns were identified on measures according to predetermined criteria for 100 adolescent survivors. Referrals for psychological follow-up services were made for concerns previously unidentified in formal assessment or not adequately addressed by current services. Results Most survivors (82%) exhibited at least one concern across domains: behavioral (76%), cognitive (47%), and emotional (19%). Behavioral concerns emerged most often on scales associated with executive dysfunction, inattention, learning, and peer difficulties. CRT was associated with cognitive concerns, χ2(1,N=100)=5.63, p<0.05. Lower income was associated with more cognitive concerns for ALL survivors, t(47)=3.28, p<0.01, and more behavioral concerns for BT survivors, t(48)=2.93, p<0.01. Of survivors with concerns, 38% were referred for psychological follow-up services. Lower-income ALL survivors received more referrals for follow-up, χ2(1,N=41)=8.05, p<0.01. Referred survivors had more concerns across domains than non-referred survivors, ALL: t(39)=2.96, p<0.01, BT: t(39)=3.52, p<0.01. Trends suggest ALL survivors may be at risk for experiencing unaddressed cognitive needs. Conclusions Many adolescent survivors of cancer experience psychological difficulties that are not adequately managed by current services, underscoring the need for long-term surveillance. In addition to prescribing regular psychological evaluations, clinicians should closely monitor whether current support services appropriately meet survivors’ needs, particularly for lower-income survivors and those treated with CRT. PMID:22278930

  11. 41 CFR 102-75.150 - What happens when GSA determines that the report of excess is adequate?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... determines that the report of excess is adequate? 102-75.150 Section 102-75.150 Public Contracts and Property... PROPERTY 75-REAL PROPERTY DISPOSAL Utilization of Excess Real Property Examination for Acceptability § 102-75.150 What happens when GSA determines that the report of excess is adequate? When GSA...

  12. 41 CFR 102-75.150 - What happens when GSA determines that the report of excess is adequate?

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... determines that the report of excess is adequate? 102-75.150 Section 102-75.150 Public Contracts and Property... PROPERTY 75-REAL PROPERTY DISPOSAL Utilization of Excess Real Property Examination for Acceptability § 102-75.150 What happens when GSA determines that the report of excess is adequate? When GSA...

  13. 41 CFR 102-75.150 - What happens when GSA determines that the report of excess is adequate?

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... determines that the report of excess is adequate? 102-75.150 Section 102-75.150 Public Contracts and Property... PROPERTY 75-REAL PROPERTY DISPOSAL Utilization of Excess Real Property Examination for Acceptability § 102-75.150 What happens when GSA determines that the report of excess is adequate? When GSA...

  14. 41 CFR 102-75.150 - What happens when GSA determines that the report of excess is adequate?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... determines that the report of excess is adequate? 102-75.150 Section 102-75.150 Public Contracts and Property... PROPERTY 75-REAL PROPERTY DISPOSAL Utilization of Excess Real Property Examination for Acceptability § 102-75.150 What happens when GSA determines that the report of excess is adequate? When GSA...

  15. 41 CFR 102-75.150 - What happens when GSA determines that the report of excess is adequate?

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... determines that the report of excess is adequate? 102-75.150 Section 102-75.150 Public Contracts and Property... PROPERTY 75-REAL PROPERTY DISPOSAL Utilization of Excess Real Property Examination for Acceptability § 102-75.150 What happens when GSA determines that the report of excess is adequate? When GSA...

  16. 40 CFR 141.522 - How does the State determine whether my system's watershed control requirements are adequate?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... my system's watershed control requirements are adequate? 141.522 Section 141.522 Protection of... Additional Watershed Control Requirements for Unfiltered Systems § 141.522 How does the State determine whether my system's watershed control requirements are adequate? During an onsite inspection...

  17. 40 CFR 141.522 - How does the State determine whether my system's watershed control requirements are adequate?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... my system's watershed control requirements are adequate? 141.522 Section 141.522 Protection of... Additional Watershed Control Requirements for Unfiltered Systems § 141.522 How does the State determine whether my system's watershed control requirements are adequate? During an onsite inspection...

  18. 40 CFR 141.522 - How does the State determine whether my system's watershed control requirements are adequate?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... my system's watershed control requirements are adequate? 141.522 Section 141.522 Protection of... Additional Watershed Control Requirements for Unfiltered Systems § 141.522 How does the State determine whether my system's watershed control requirements are adequate? During an onsite inspection...

  19. 40 CFR 141.522 - How does the State determine whether my system's watershed control requirements are adequate?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... my system's watershed control requirements are adequate? 141.522 Section 141.522 Protection of... Additional Watershed Control Requirements for Unfiltered Systems § 141.522 How does the State determine whether my system's watershed control requirements are adequate? During an onsite inspection...

  20. 21 CFR 1.284 - What are the other consequences of failing to submit adequate prior notice or otherwise failing...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... submit adequate prior notice or otherwise failing to comply with this subpart? 1.284 Section 1.284 Food... failing to submit adequate prior notice or otherwise failing to comply with this subpart? (a) The importing or offering for import into the United States of an article of food in violation of...

  1. 21 CFR 1.284 - What are the other consequences of failing to submit adequate prior notice or otherwise failing...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... submit adequate prior notice or otherwise failing to comply with this subpart? 1.284 Section 1.284 Food... failing to submit adequate prior notice or otherwise failing to comply with this subpart? (a) The importing or offering for import into the United States of an article of food in violation of...

  2. 21 CFR 1.284 - What are the other consequences of failing to submit adequate prior notice or otherwise failing...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... submit adequate prior notice or otherwise failing to comply with this subpart? 1.284 Section 1.284 Food... failing to submit adequate prior notice or otherwise failing to comply with this subpart? (a) The importing or offering for import into the United States of an article of food in violation of...

  3. 21 CFR 1.284 - What are the other consequences of failing to submit adequate prior notice or otherwise failing...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... submit adequate prior notice or otherwise failing to comply with this subpart? 1.284 Section 1.284 Food... failing to submit adequate prior notice or otherwise failing to comply with this subpart? (a) The importing or offering for import into the United States of an article of food in violation of...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 40 CFR 141.522 - How does the State determine whether my system's watershed control requirements are adequate?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... my system's watershed control requirements are adequate? 141.522 Section 141.522 Protection of... Additional Watershed Control Requirements for Unfiltered Systems § 141.522 How does the State determine whether my system's watershed control requirements are adequate? During an onsite inspection...

  10. Money and morals: ending clinical trials for financial reasons.

    PubMed

    Eaton, Margaret L; Kwon, Brian K; Scott, Christopher Thomas

    2015-01-01

    Too often, biopharmaceutical companies stop their clinical trials solely for financial reasons. In this chapter, we discuss this phenomenon against the backdrop of a 2011 decision by Geron Corporation to abandon its stem cell clinical trial for spinal cord injury (SCI), the preliminary results of which were released in May 2014. We argue that the resultant harms are widespread and are different in nature from the consequences of stopping trials for scientific or medical reasons. We examine the ethical and social effects that arise from such decisions and discuss them in light of ethical frameworks, including duties of individual stakeholders and corporate sponsors. We offer ways that sponsors and clinical sites can ensure that trials are responsibly started, and once started adequately protect the interests of participants. We conclude with recommendations that industry sponsors of clinical trials should adopt in order to advance a collective and patient-centered research ethic. PMID:25062706

  11. Managing clinical trials.

    PubMed

    Farrell, Barbara; Kenyon, Sara; Shakur, Haleema

    2010-01-01

    Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field. For the past three decades, trialists have invented and reinvented the trial management wheel. We suggest that to improve the successful, timely delivery of important clinical trials for patient benefit, it is time to produce standard trial management guidelines and develop robust methods of evaluation. PMID:20626885

  12. 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)

  13. Reporting, access, and transparency: better infrastructure of clinical trials.

    PubMed

    Antonelli, Massimo; Mercurio, Giovanna

    2009-01-01

    Open access to information in medical science and adequate reporting of clinical trials may allow investigators and editors to recognize bias in study designs and avoid unnecessary duplication of efforts. Unfortunately, most of clinical trials are very expensive and are often supported by industries that may have financial reasons to hide or partially disclose results. However, investigators and editors have a greater interest in publishing results that can immediately change clinical practice rather than negative results, thus contributing to facilitate publication biases. Several years ago, legislation in several countries mandated the registration of clinical trials as an effective means of promoting information access and full transparency in medical research. However, comprehensive registers have not been adequately supported by law, particularly in Europe, where legislation has ironically contributed to fragmented research, and dampened its competitiveness and productivity. In this context, appropriate strategies help to protect the independence of academic research and ensure full transparency in medical science. PMID:19104221

  14. 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

  15. Special article: 2014 Pediatric Clinical Trials Forum.

    PubMed

    Bogue, Clifford; DiMeglio, Linda A; Maldonado, Samuel; Portman, Ronald J; Smith, P Brian; Sullivan, Janice E; Thompson, Charles; Woo, Heide; Flinn, Susan

    2016-04-01

    In November 2014, the American Academy of Pediatrics convened key stakeholders to discuss the feasibility of accelerating children's medical advances by creating an independent global Pediatric Clinical Trials Network. The Forum identified challenges posed by the US and global clinical trial systems regarding testing and disseminating drugs and devices for pediatric patients. Stakeholders mapped a vision to improve the safety and efficacy of pediatric drugs, biological products, and medical devices by creating a global Pediatric Clinical Trials Network. Such a Network would act as a central infrastructure for pediatric subspecialties and enable dedicated staff to provide clinical research sites with scientific, medical, and operational support. A Network would facilitate development and availability of innovative, high-quality therapies to extend and enhance the lives of neonates, infants, children, adolescents, and young adults. Participants expressed strong interest in forming such a Network, since drugs and devices still come to market without adequate pediatric indications-particularly in neonatology and rare diseases. Participants developed a Consensus Statement expressing their shared vision for a Network: Attendees of the Pediatric Clinical Trials Stakeholder Forum resolved to establish a Global Pediatric Clinical Trials Network and are committed to engage in the work to create and sustain it. PMID:26650344

  16. Remune trial will stop; new trials planned.

    PubMed

    James, J S

    1999-05-21

    A clinical trial using remune, the anti-HIV vaccine developed by the late Dr. Jonas Salk, has been ended. The study is a clinical-endpoint trial which looks for statistically significant differences in AIDS sickness or death between patients who add remune to their treatment regimens versus those who use a placebo. Agouron Pharmaceuticals and the Immune Response Corporation who were conducting the trial announced their decision to stop it after an analysis by the Data Safety Monitoring Board. No differences in clinical endpoints were found and it was projected that continuing the trial would likely not find any. The companies are now planning two new Phase III trials using viral load testing rather than clinical endpoints as study criteria. PMID:11366461

  17. 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)

  18. 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.

  19. 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.

  20. ClinicalTrials.gov

    MedlinePlus

    ... Health ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of ... This Site ClinicalTrials.gov Background About the Results Database History, Policies, and Laws Media/Press Resources Linking ...

  1. 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 ...

  2. Rare disease clinical trials: Power in numbers.

    PubMed

    Wicklund, Matthew P

    2016-08-01

    The limb-girdle muscular dystrophies (LGMDs) encompass a collection of genetic muscle diseases with proximal-predominant weakness of the limbs. Thirty-two of these disorders are named via the common nomenclature, including 8 autosomal-dominant (LGMD1A-H) and 24 autosomal-recessive (LGMD2A-X) disorders.(1) In addition, numerous other genetic muscle diseases, including Bethlem myopathy, dystrophinopathies, ryanodine receptor-associated myopathies, and many more, may clinically present with similar proximal-predominant weakness.(2) Therefore, current genetic testing panels targeting neuromuscular weakness frequently encompass >75 genes. These disorders are quite rare, each with minimum prevalence estimates of 0.01-0.60 cases per 100,000 persons.(3) LGMD2A (attributable to mutations in the gene for calpain-3) and LGMD2B (attributable to mutations in the gene for dysferlin) consistently are the 2 most prevalent LGMD subtypes in a variety of ethnic cohorts. PMID:27540592

  3. Vitamin D: what is an adequate vitamin D level and how much supplementation is necessary?

    PubMed

    Bischoff-Ferrari, Heike

    2009-12-01

    Strong evidence indicates that many or most adults in the United States and Europe would benefit from vitamin D supplements with respect to fracture and fall prevention, and possibly other public health targets, such as cardiovascular health, diabetes and cancer. This review discusses the amount of vitamin D supplementation needed and a desirable 25-hydroxyvitamin D level to be achieved for optimal musculoskeletal health. Vitamin D modulates fracture risk in two ways: by decreasing falls and increasing bone density. Two most recent meta-analyses of double-blind randomised controlled trials came to the conclusion that vitamin D reduces the risk of falls by 19%, the risk of hip fracture by 18% and the risk of any non-vertebral fracture by 20%; however, this benefit was dose dependent. Fall prevention was only observed in a trial of at least 700 IU vitamin D per day, and fracture prevention required a received dose (treatment dose*adherence) of more than 400 IU vitamin D per day. Anti-fall efficacy started with achieved 25-hydroxyvitamin D levels of at least 60 nmol l(-1) (24 ng ml(-1)) and anti-fracture efficacy started with achieved 25-hydroxyvitamin D levels of at least 75 nmol l(-1) (30 ng ml(-1)) and both endpoints improved further with higher achieved 25-hydroxyvitamin D levels. Founded on these evidence-based data derived from the general older population, vitamin D supplementation should be at least 700-1000 IU per day and taken with good adherence to cover the needs for both fall and fracture prevention. Ideally, the target range for 25-hydroxyvitamin D should be at least 75 nmol l(-1), which may need more than 700-1000 IU vitamin D in individuals with severe vitamin D deficiency or those overweight. PMID:19945690

  4. Utah Mock Trial Competition.

    ERIC Educational Resources Information Center

    Oswald, Linda, Comp.

    Background materials and guidelines for secondary students and educators in Utah who wish to participate in the state-wide mock trial competition are provided. Many parts of the publication can be used by educators in other states who are using mock trials in their classrooms or who are developing a state-wide mock trial competition. The manual…

  5. 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)

  6. 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

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

    PubMed

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

    2015-02-01

    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

  8. 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.

  9. [Rhythmic nuclear growth of adequately stimulated ganglia cells of acoustic nuclei (rat)].

    PubMed

    Köpf-Maier, P; Wüstenfeld, E

    1975-01-01

    Ganglia cells of the dorsal and ventral cochlear nuclei of white rats were irritated adequately for different periods or left untreated, respectively, and investigated karyometrically. The frequency distribution curves of the nuclear volumes were separated by means of an electronic curve resolver into the component curves, i.e. into groups of nuclei obeying exactly a Gaussian normal distribution and thus representing biologically uniform populations. The analysis of the mean values of the component curves led to the following results: 1. The mean values of the component curves can be arranged in 2 series having the pattern V1, V1 square root 2, V2, V2 square root 2, V4, V4 square root 2...2. The series V1, V1 square root 2, V2, V2 square root 2...is based on a geometrical series of the general formula an = k-qn. 3. It follows from these results that the nuclear volumes grow rhythmically by a factor of square root 2 and, consequently, that there is a periodical doubling in in the growth of the surface. PMID:1200386

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

    PubMed Central

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

    2013-01-01

    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. PMID:20298639

  11. 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

  12. A negative cranial computed tomographic scan is not adequate to support a diagnosis of pseudotumor cerebri.

    PubMed

    Said, Rana R; Rosman, N Paul

    2004-08-01

    A 10-year-old boy with daily headache for 1 month and intermittent diplopia for 1 week was found to have a unilateral partial abducens palsy and bilateral papilledema; otherwise, his neurologic examination showed no abnormalities. A cranial computed tomographic (CT) scan was normal. Lumbar puncture disclosed a markedly elevated opening pressure of > 550 mm of cerebrospinal fluid with normal cerebrospinal fluid. Medical therapy with acetazolamide for presumed pseudotumor cerebri was begun. Magnetic resonance imaging (MRI) of the brain, done several days later because of continuing symptoms, unexpectedly showed multiple hyperintensities of cerebral white matter on T2-weighted and fluid-attenuated inversion recovery images. Despite high-dose intravenous methylprednisolone for possible demyelinating disease, he failed to improve. A left temporal brain biopsy followed and disclosed an anaplastic oligodendroglioma. In a patient with features indicating pseudotumor cerebri, a negative cranial CT scan is not adequate to rule out underlying pathology; thus, MRI of the brain should probably always be performed. A revised definition of pseudotumor cerebri could better include "normal MRI of the brain" rather than "normal neuroimaging." PMID:15605471

  13. 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.

  14. 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.

  15. [Level of awareness and the adequate application of sunscreen by beauticians].

    PubMed

    Cortez, Diógenes Aparício Garcia; Machado, Érica Simionato; Vermelho, Sonia Cristina Soares Dias; Teixeira, Jorge Juarez Vieira; Cortez, Lucia Elaine Ranieri

    2016-06-01

    The scope of this research was to establish the level of awareness of beauticians regarding the importance of the application of sunscreen and to identify whether their patients had been properly instructed by these professionals. It involved a descriptive and exploratory study with interviews applying qualitative methodology among 30 beauticians. Data were gathered using the semi-structured interview technique in Maringá, in the southern state of Paraná. The data were analyzed using Atlas.ti software after applying quantitative analysis and response classification. Of those interviewed, 83.33% had a degree in Aesthetics, 20% attended ongoing training activities on sunscreen and 73.17% acquired sunscreen for its quality, though 86.67% were not familiar with sunscreens with natural anti-free radical components. Of those interviewed, 80% had never treated patients with skin cancer, though they reported having knowledge of care in relation to sun exposure and how to use the sunscreen and the relationship of these practices with the disease. The results showed that the recommendations and use of sunscreen by beauticians and users has been conducted in an adequate and conscientious manner. PMID:27383359

  16. The menopause, hormone replacement therapy and informed consent: are women in an underresourced country adequately aware?

    PubMed

    Maharaj, N R; Gangaram, R; Moodley, J

    2007-04-01

    Recent evidence on the long-term effects of HRT have resulted in increased emphasis being placed on individualised counselling, patient choice and informed consent when managing the menopause. We assessed whether women in an underresourced country have adequate knowledge of the menopause/HRT to engage in patient - provider discussions and provide full informed consent for HRT. Specific 'knowledge scores' for the menopause and HRT were developed and utilised in structured questionnaires to determine the existing levels of knowledge in 150 women from different racial, educational and occupational backgrounds. Some 92% were aware of the menopause and 54% were aware of HRT. Specific knowledge about the menopause and HRT overall was low (39% and 38%, respectively). There was a significant association between higher education levels, race and occupational status on the knowledge of the menopause but not of HRT. Television, radio and pamphlets were the preferred sources to gain further information. There is a need to create awareness and provide further education to women in underresourced countries about the menopause and HRT to empower them to make informed choices about their health during this period. PMID:17464817

  17. 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.

  18. [Adequate attention is required to the diagnosis and treatment of mild-symptom erectile dysfunction].

    PubMed

    Deng, Chun-hua; Zhang, Ya-dong; Chen, Xin

    2015-01-01

    Mild-symptom erectile dysfunction (MSED) is commonly seen in clinical practice, but receives inadequate attention from both the patients and clinicians. Increasing researches have indicated that MSED is associated with not only unhealthy living habits and psychological factors but also the early progression of endothelial, metabolic and endocrine diseases. The diagnosis and treatment of MSED should be based on the relevant guidelines, with consideration of both its specific and common features. The therapeutic principle is a combination of integrated and individual solutions aimed at the causes of the disease. Drug intervention should be initiated if psychological therapy fails. Negligence of MSED may affect the quality of life of the patients and their partners, and what's more, might delay the management of some other severe underlying diseases. Adequate attention to the early diagnosis and treatment for MSED is of great significance for a deeper insight into the etiology of ED, the prevention of potential cardiovascular and metabolic diseases, and the improvement of the overall health of males. PMID:25707132

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

    NASA Technical Reports Server (NTRS)

    Juarez, Alfredo; Harper, Susana A.

    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.

  20. 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

  1. Evaluation of catheter-manometer systems for adequate intravascular blood pressure measurements in small animals.

    PubMed

    Idvall, J; Aronsen, K F; Lindström, K; Ulmsten, U

    1977-09-30

    Various catheter-manometer systems possible for intravascular blood pressure measurments on rats have been elaborated and tested in vitro and in vivo. Using a pressure-step calibrator, it was observed from in vitro studies that microtransducers had superior frequency response compared to conventional transducers. Of the catheters tested, Pe-90 tapered to a 40 mm tip with an inner diameter of 0.3 mm had the best frequency response as judged from fall and settling times. Because of the damping effect, tapering increased fall time to 1.8 ms, which was still quite acceptable. By the same token settling time was minimized to 22.4 ms. With a special calculation method the theoretical percentile fault of the recordings was estimated to be 9.66%. When the measurement error was calculated from the actual in vivo recordings, it was found to be no more than 2.7%. These results show that the technique described is adequate for continuous intravascular blood pressure recordings on small animals. Finally it is emphasized that careful handling of the catheters and avoidance of stopcocks and air bubbles are essential for obtaining accurate and reproducible values. PMID:928971

  2. Is reimbursement for childhood immunizations adequate? evidence from two rural areas in colorado.

    PubMed Central

    Glazner, J. E.; Steiner, J. F.; Haas, K. J.; Renfrew, B.; Deutchman, M.; Berman, S.

    2001-01-01

    OBJECTIVE: To assess adequacy of reimbursement for childhood vaccinations in two rural regions in Colorado, the authors measured medical practice costs of providing childhood vaccinations and compared them with reimbursement. METHODS: A "time-motion" method was used to measure labor costs of providing vaccinations in 13 private and public practices. Practices reported non-labor costs. The authors determined reimbursement by record review. RESULTS: The average vaccine delivery cost per dose (excluding vaccine cost) ranged from $4.69 for community health centers to $5.60 for private practices. Average reimbursement exceeded average delivery costs for all vaccines and contributed to overhead in private practices. Average reimbursement was less than total cost (vaccine-delivery costs + overhead) in private practices for most vaccines in one region with significant managed care penetration. Reimbursement to public providers was less than the average vaccine delivery costs. CONCLUSIONS: Current reimbursement may not be adequate to induce private practices to provide childhood vaccinations, particularly in areas with substantial managed care penetration. PMID:12034911

  3. Adequate Vitamin D3 Supplementation During Pregnancy: Decreasing the Prevalence of Asthma and Food Allergies

    PubMed Central

    Finkel, Jonathan; Cira, Courtney; Mazzella, Leanne; Bartyzel, Jim; Ramanna, Annisce; Strimel, Kayla; Waturuocha, Amara; Musser, Nathan; Burress, James; Brammer, Sarah; Wetzel, Robert; Horzempa, Joseph

    2016-01-01

    Vitamin D is a secosterol that is naturally synthesized in the skin upon contact with ultraviolet rays. This vitamin can also be acquired from dietary and nutritional supplements. The active form, vitamin D3, is primarily responsible for calcium homeostasis and bone health. However, many recent studies have associated low levels of vitamin D3 with asthma and food allergies. In this review, we discuss literature to explore the potential that vitamin D3 deficiency may be contributing toward the development of asthma and food allergies. These studies indicate that mothers who supplement with doses of vitamin D3 recommended for daily consumption (400 IU) by the United States Food and Drug Administration is not enough to deliver adequate levels to breastfed infants. Because sufficient vitamin D3 serum levels correlate with a low incidence of asthma and food allergies, high dose vitamin D3 supplementation (4000 IU) by pregnant and breastfeeding women may limit the development of asthma and food allergies in newborns. PMID:27213185

  4. 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. PMID:20298639

  5. Neurocysticercosis, familial cerebral cavernomas and intracranial calcifications: differential diagnosis for adequate management.

    PubMed

    Gasparetto, Emerson Leandro; Alves-Leon, Soniza; Domingues, Flavio Sampaio; Frossard, João Thiago; Lopes, Selva Paraguassu; Souza, Jorge Marcondes de

    2016-06-01

    Neurocysticercosis (NCC) is an endemic disease and important public health problem in some areas of the World and epilepsy is the most common neurological manifestation. Multiple intracranial lesions, commonly calcified, are seen on cranial computed tomography (CT) in the chronic phase of the disease and considered one of the diagnostic criteria of the diagnosis. Magnetic resonance imaging (MRI) is the test that better depicts the different stages of the intracranial cysts but does not show clearly calcified lesions. Cerebral cavernous malformations (CCM), also known as cerebral cavernomas, are frequent vascular malformations of the brain, better demonstrated by MRI and have also epilepsy as the main form of clinical presentation. When occurring in the familial form, cerebral cavernomas typically present with multiple lesions throughout the brain and, very often, with foci of calcifications in the lesions when submitted to the CT imaging. In the countries, and geographic areas, where NCC is established as an endemic health problem and neuroimaging screening is done by CT scan, it will be important to consider the differential diagnosis between the two diseases due to the differences in adequate management. PMID:27332076

  6. Splenic autotransplantation and the immune system. Adequate testing required for evaluation of effect.

    PubMed Central

    Timens, W; Leemans, R

    1992-01-01

    The risk of severe infections after splenectomy, even after many years, is now well established. In attempts to prevent these infections, spleen-saving techniques, including autotransplantation of spleen fragments, have been performed, when possible in combination with vaccination. The problem in autotransplantation is the evaluation of functional activity. The results of the tests used until now often do not seem to correlate very well with the risk of developing an overwhelming postsplenectomy infection (OPSI). This may be related to the fact that the tests used evaluate general functions, and not specific spleen-related functions, such as the capacity to mount a primary response to certain polysaccharide antigens present in the capsule of bacteria known to cause OPSI. In this review, the significance of the spleen in the human immune system is discussed and the effects of splenectomy are described, including the precautions that can be taken to diminish the risk of postsplenectomy infections and sepsis. It appears that postsplenectomy vaccination is more successful when recently developed protein-conjugated polysaccharide vaccines are used. Because the present testing of the function of spleen autotransplants is not adequate, we suggest that new tests should be developed, employing appropriate polysaccharide antigens. PMID:1543398

  7. Association of trial registration with the results and conclusions of published trials of new oncology drugs

    PubMed Central

    2009-01-01

    Background Registration of clinical trials has been introduced largely to reduce bias toward statistically significant results in the trial literature. Doubts remain about whether advance registration alone is an adequate measure to reduce selective publication, selective outcome reporting, and biased design. One of the first areas of medicine in which registration was widely adopted was oncology, although the bulk of registered oncology trials remain unpublished. The net influence of registration on the literature remains untested. This study compares the prevalence of favorable results and conclusions among published reports of registered and unregistered randomized controlled trials of new oncology drugs. Methods We conducted a cross-sectional study of published original research articles reporting clinical trials evaluating the efficacy of drugs newly approved for antimalignancy indications by the United States Food and Drug Administration (FDA) from 2000 through 2005. Drugs receiving first-time approval for indications in oncology were identified using the FDA web site and Thomson Centerwatch. Relevant trial reports were identified using PubMed and the Cochrane Library. Evidence of advance trial registration was obtained by a search of clinicaltrials.gov, WHO, ISRCTN, NCI-PDQ trial databases and corporate trial registries, as well as articles themselves. Data on blinding, results for primary outcomes, and author conclusions were extracted independently by two coders. Univariate and multivariate logistic regression identified associations between favorable results and conclusions and independent variables including advance registration, study design characteristics, and industry sponsorship. Results Of 137 original research reports from 115 distinct randomized trials assessing 25 newly approved drugs for treating cancer, the 54 publications describing data from trials registered prior to publication were as likely to report statistically significant efficacy

  8. 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

  9. Physiotherapy Post Lumbar Discectomy: Prospective Feasibility and Pilot Randomised Controlled Trial

    PubMed Central

    Rushton, Alison; Goodwin, Peter C.

    2015-01-01

    demonstrated a trend in reducing disability in this population. A randomised controlled trial, using a different trial design, is needed to ascertain the effectiveness of combining the interventions into a stepped care intervention and comparing to a no intervention arm. Findings will guide design changes for an adequately powered randomised controlled trial, using RMDQ as the primary outcome. Trial Registration ISRCTN registry 33808269 PMID:26562660

  10. Clinical Trials in Vision Research

    MedlinePlus

    ... Clinical Trials in Vision Research Clinical Trials in Vision Research Clinical studies depend on people who volunteer. ... about the treatment. How are clinical trials in vision different from other clinical trials? Eyes are one ...

  11. AIDS Clinical Trials Group Network

    MedlinePlus

    ... Center Statistical and Data Management Center Glossaries Sites Clinical Trials About the Trial Process Trials Open to Enrollment Recent Study Results Access to Published Data Clinical Trials Resources Committees Executive Scientific Resource Community General Information ...

  12. 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

  13. 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

    ... 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...

  14. Prioritising pharmaceuticals for environmental risk assessment: Towards adequate and feasible first-tier selection.

    PubMed

    Roos, V; Gunnarsson, L; Fick, J; Larsson, D G J; Rudén, C

    2012-04-01

    The presence of pharmaceuticals in the aquatic environment, and the concerns for negative effects on aquatic organisms, has gained increasing attention over the last years. As ecotoxicity data are lacking for most active pharmaceutical ingredients (APIs), it is important to identify strategies to prioritise APIs for ecotoxicity testing and environmental monitoring. We have used nine previously proposed prioritisation schemes, both risk- and hazard-based, to rank 582 APIs. The similarities and differences in overall ranking results and input data were compared. Moreover, we analysed how well the methods ranked seven relatively well-studied APIs. It is concluded that the hazard-based methods were more successful in correctly ranking the well-studied APIs, but the fish plasma model, which includes human pharmacological data, also showed a high success rate. The results of the analyses show that the input data availability vary significantly; some data, such as logP, are available for most API while information about environmental concentrations and bioconcentration are still scarce. The results also suggest that the exposure estimates in risk-based methods need to be improved and that the inclusion of effect measures at first-tier prioritisation might underestimate risks. It is proposed that in order to develop an adequate prioritisation scheme, improved data on exposure such as degradation and sewage treatment removal and bioconcentration ability should be further considered. The use of ATC codes may also be useful for the development of a prioritisation scheme that includes the mode of action of pharmaceuticals and, to some extent, mixture effects. PMID:22361586

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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.

  20. 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

    2016-01-01

    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. PMID:27173351

  1. AVP-825 Breath-Powered Intranasal Delivery System Containing 22 mg Sumatriptan Powder vs 100 mg Oral Sumatriptan in the Acute Treatment of Migraines (The COMPASS Study): A Comparative Randomized Clinical Trial Across Multiple Attacks

    PubMed Central

    Tepper, Stewart J; Cady, Roger K; Silberstein, Stephen; Messina, John; Mahmoud, Ramy A; Djupesland, Per G; Shin, Paul; Siffert, Joao

    2015-01-01

    Objective The objective of this study was to compare the efficacy, tolerability, and safety of AVP-825, an investigational bi-directional breath-powered intranasal delivery system containing low-dose (22 mg) sumatriptan powder, vs 100 mg oral sumatriptan for acute treatment of migraine in a double-dummy, randomized comparative efficacy clinical trial allowing treatment across multiple migraine attacks. Background In phases 2 and 3, randomized, placebo-controlled trials, AVP-825 provided early and sustained relief of moderate or severe migraine headache in adults, with a low incidence of triptan-related adverse effects. Methods This was a randomized, active-comparator, double-dummy, cross-over, multi-attack study (COMPASS; NCT01667679) with two ≤12-week double-blind periods. Subjects experiencing 2-8 migraines/month in the past year were randomized 1:1 using computer-generated sequences to AVP-825 plus oral placebo tablet or an identical placebo delivery system plus 100 mg oral sumatriptan tablet for the first period; patients switched treatment for the second period in this controlled comparative design. Subjects treated ≤5 qualifying migraines per period within 1 hour of onset, even if pain was mild. The primary end-point was the mean value of the summed pain intensity differences through 30 minutes post-dose (SPID-30) using Headache Severity scores. Secondary outcomes included pain relief, pain freedom, pain reduction, consistency of response across multiple migraines, migraine-associated symptoms, and atypical sensations. Safety was also assessed. Results A total of 275 adults were randomized, 174 (63.3%) completed the study (ie, completed the second treatment period), and 185 (67.3%) treated at least one migraine in both periods (1531 migraines assessed). There was significantly greater reduction in migraine pain intensity with AVP-825 vs oral sumatriptan in the first 30 minutes post-dose (least squares mean SPID-30 = 10.80 vs 7.41, adjusted mean

  2. 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. PMID:26135330

  3. Antibiotic trials for coronary heart disease.

    PubMed

    Anderson, Jeffrey L; Muhlestein, Joseph B

    2004-01-01

    The possibility has been raised in recent years that infection might contribute as an inflammatory stimulus to chronic "noninfectious" degenerative diseases. Within the past decade, serious attention has been given to the possibility of bacterial vectors as causal factors of atherosclerosis. To date, the greatest amount of information has related to the intracellular organism Chlamydia pneumoniae. This interest has been stimulated by the frequent finding of bacterial antigens and, occasionally, recoverable organisms, within human atherosclerotic plaque. Indirect evidence for and against the benefit of anti-Chlamydia antibiotic agents comes from epidemiologic studies. Given the potential for confounding in observational studies, prospective, randomized intervention trials are required. These antibiotic trials have generated enthusiastic expectations for proving (or disproving) the infectious-disease hypothesis of atherosclerosis and establishing new therapies. However, these expectations have been tempered by important limitations and uncertainties. Negative outcomes can be explained not only by an incorrect hypothesis but also by inadequate study size or design or by an ineffective antibiotic regimen. In contrast, if studies are positive, the hypothesis still is not entirely proved, because a nonspecific anti-inflammatory effect or an anti-infective action against other organisms might be operative. The clinical trial data to date have not provided adequate support for the clinical use of antibiotics in primary or secondary prevention of coronary heart disease. New and innovative experimental approaches, in addition to traditionally designed antibiotic trials, should be welcome in our attempts to gain adequate insight into the role of infection in atherosclerosis and its therapy. PMID:15061624

  4. 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

  5. Is serum or sputum eosinophil cationic protein level adequate for diagnosis of mild asthma?

    PubMed

    Khakzad, Mohammad Reza; Mirsadraee, Majid; Sankian, Mojtaba; Varasteh, Abdolreza; Meshkat, Mojtaba

    2009-09-01

    Spirometry has been used as a common diagnostic test in asthma. Most of the patients with a mild asthma have a FEV1 within normal range. Hence, other diagnostic methods are usually used. The aim of this study was to evaluate whether eosinophil Cationic Protein (ECP) could be an accurate diagnostic marker of mild asthma. In this study diagnosis of asthma was made according to internationally accepted criteria. Asthma severity was evaluated according to frequency of symptoms and FEV1.Adequate sputum samples were obtained in 50 untreated subjects. A control group of 12 normal subjects that showed PC20 more than 8 mg/dl was also examined. Sputum was induced by inhalation of hypertonic saline. Inflammatory cells in sputum smears were assessed semi-quantitatively. ECP and IgE concentrations, eosinophil (EO) percentage and ECP/EO ratio in serum and sputum were also determined. The results revealed that Cough and dyspnea were the most frequent clinical findings. Dyspnea and wheezing were the symptoms that correlated with staging of asthma. FEV1 was within normal range (more than 80% of predicted) in 22 (44%) subjects.Asthmatic patients showed significantly higher numbers of blood eosinophils (4.5+/- 3.1% vs. 1.2+/-0.2%, P=0.009), and higher levels of serum ECP than control group (3.1+/- 2.6 % and 22.6+/- 15.8 ng/ml, respectively). Sputum ECP level in asthmatics was significantly higher than non- asthmatics (55.3+/-29.8ng/mL vs. 25.0+/-24.7ng/mL, P=0.045). Regression analysis showed no significant correlation between spirometric parameters and biomarkers, the only exception was significant correlation between FEF(25-75) and serum ECP (r= 0.28, P 0.041). Regarding clinical symptoms, wheezing was significantly correlated with elevation of most of biomarkers. Since, serum and sputum ECP levels are elevated in untreated asthmatics, the ECP level could be used for accurate diagnosis of mild form of asthma in which spirometry is unremarkable. PMID:20124607

  6. Human milk feeding supports adequate growth in infants ≤ 1250 grams birth weight

    PubMed Central

    2013-01-01

    Background 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 objective of this study was to evaluate growth velocities and incidence of extrauterine growth restriction in infants ≤ 1250 grams (g) birth weight (BW) receiving an exclusive human milk-based diet with early and rapid advancement of fortification using a donor human milk derived fortifier. Methods In a single center, prospective observational cohort study, preterm infants weighing ≤ 1250 g BW were fed an exclusive human milk-based diet until 34 weeks postmenstrual age. Human milk fortification with donor human milk derived fortifier was started at 60 mL/kg/d and advanced to provide 6 to 8 additional kilocalories per ounce (or 0.21 to 0.28 kilocalories per gram). Data for growth were compared to historical growth standards and previous human milk-fed cohorts. Results We consecutively evaluated 104 infants with mean gestational age of 27.6 ± 2.0 weeks and BW of 913 ± 181 g (mean ± standard deviation). Weight gain was 24.8 ± 5.4 g/kg/day with length 0.99 ± 0.23 cm/week and head circumference 0.72 ± 0.14 cm/week. There were 3 medical NEC cases and 1 surgical NEC case. 22 infants (21%) were small for gestational age at birth. Overall, 45 infants (43%) had extrauterine growth restriction. Weight velocity was affected by day of fortification (p = 0.005) and day of full feeds (p = 0.02). Our cohort had significantly greater growth in weight and length compared to previous entirely human milk-fed cohorts. Conclusions A feeding protocol for infants ≤ 1250 g BW providing an exclusive human milk-based diet with early and rapid advancement of fortification leads to growth meeting targeted standards with a low rate of extrauterine growth restriction. Consistent

  7. Shoulder Arthroscopy Does Not Adequately Visualize Pathology of the Long Head of Biceps Tendon

    PubMed Central

    Saithna, Adnan; Longo, Alison; Leiter, Jeff; Old, Jason; MacDonald, Peter M.

    2016-01-01

    Background: Pulling the long head of the biceps tendon into the joint at arthroscopy is a common method for evaluation of tendinopathic lesions. However, the rate of missed diagnoses when using this technique is reported to be as high as 30% to 50%. Hypothesis: Tendon excursion achieved using a standard arthroscopic probe does not allow adequate visualization of extra-articular sites of predilection of tendinopathy. Study Design: Descriptive laboratory study. Methods: Seven forequarter amputation cadaveric specimens were evaluated. The biceps tendon was tagged to mark the intra-articular length and the maximum excursions achieved using a probe and a grasper in both beach-chair and lateral positions. Statistical analyses were performed using analysis of variance to compare means. Results: The mean intra-articular and extra-articular lengths of the tendons were 23.9 and 82.3 mm, respectively. The length of tendon that could be visualized by pulling it into the joint with a probe through the anterior midglenoid portal was not significantly different when using either lateral decubitus (mean ± SD, 29.9 ± 3.89 mm; 95% CI, 25.7-34 mm) or beach-chair positions (32.7 ± 4.23 mm; 95% CI, 28.6-36.8 mm). The maximum length of the overall tendon visualized in any specimen using a standard technique was 37 mm. Although there was a trend to greater excursion using a grasper through the same portal, this was not statistically significant. However, using a grasper through the anterosuperior portal gave a significantly greater mean excursion than any other technique (46.7 ± 4.31 mm; 95% CI, 42.6-50.8 mm), but this still failed to allow evaluation of Denard zone C. Conclusion: Pulling the tendon into the joint with a probe via an anterior portal does not allow visualization of distal sites of predilection of pathology. Surgeons should be aware that this technique is inadequate and can result in missed diagnoses. Clinical Relevance: This study demonstrates that glenohumeral

  8. 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

  9. Is fine-needle aspiration diagnosis of malignancy adequate prior to major lung resections including pneumonectomy?

    PubMed

    Khorsandi, Maziar; Shaikhrezai, Kasra; Wallace, William; Brackenbury, Edward

    2012-08-01

    A best evidence topic in thoracic surgery was written according to a structured protocol. The question addressed was whether a fine-needle aspiration (FNA) diagnosis is of sufficient reliability for the diagnosis of lung cancer prior to a major lung resection. Altogether, 112 papers were found using the reported search, of which 13 papers presented the best evidence to answer the clinical question. The author, journal, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses of these papers are tabulated. The tabulated studies include two meta-analyses, one systematic review, one randomized controlled trial (RCT) and nine cohort studies. The specificity reported for FNA in the diagnosis and staging of lung cancer ranged from 96.2 to 100%. One meta-analysis reported a specificity of 97%. Another meta-analysis reported a specificity of 98.8%. A systematic review reported a specificity of 97%. An RCT reported a specificity of 96.2-100%. We conclude that the FNA for lung cancer is reported to be highly specific prior to major lung resection with a very low false positive rate. However, although a false positive may occasionally be acceptable in lobectomies, where the lobes are often removed without histology, all steps should be taken to avoid a false positive result in pneumonectomy considering the serious consequences of embarking upon such an operation in the small number of patients with a false positive result, and we recommend that a positive FNA result should be confirmed by means of alternative sampling methods. We also acknowledge that obtaining an additional biopsy specimen would add to the risk of morbidity and costs; therefore, any benefits should be weighed against risks and additional costs. PMID:22611184

  10. 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. PMID:26134040

  11. 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

    2011-01-01

    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. PMID:21658262

  12. Quasi-Isotropic Approximation of Geometrical Optics Method as Adequate Electrodynamical Basis for Tokamak Plasma Polarimetry

    NASA Astrophysics Data System (ADS)

    Bieg, Bohdan; Chrzanowski, Janusz; Kravtsov, Yury A.; Orsitto, Francesco

    Basic principles and recent findings of quasi-isotropic approximation (QIA) of a geometrical optics method are presented in a compact manner. QIA was developed in 1969 to describe electromagnetic waves in weakly anisotropic media. QIA represents the wave field as a power series in two small parameters, one of which is a traditional geometrical optics parameter, equal to wavelength ratio to plasma characteristic scale, and the other one is the largest component of anisotropy tensor. As a result, "" QIA ideally suits to tokamak polarimetry/interferometry systems in submillimeter range, where plasma manifests properties of weakly anisotropic medium.

  13. The content of African diets is adequate to achieve optimal efficacy with fixed-dose artemether-lumefantrine: a review of the evidence

    PubMed Central

    Premji, Zulfiqarali G; Abdulla, Salim; Ogutu, Bernhards; Ndong, Alice; Falade, Catherine O; Sagara, Issaka; Mulure, Nathan; Nwaiwu, Obiyo; Kokwaro, Gilbert

    2008-01-01

    A fixed-dose combination of artemether-lumefantrine (AL, Coartem®) has shown high efficacy, good tolerability and cost-effectiveness in adults and children with uncomplicated malaria caused by Plasmodium falciparum. Lumefantrine bioavailability is enhanced by food, particularly fat. As the fat content of sub-Saharan African meals is approximately a third that of Western countries, it raises the question of whether fat consumption by African patients is sufficient for good efficacy. Data from healthy volunteers have indicated that drinking 36 mL soya milk (containing only 1.2 g of fat) results in 90% of the lumefantrine absorption obtained with 500 mL milk (16 g fat). African diets are typically based on a carbohydrate staple (starchy root vegetables, fruit [plantain] or cereals) supplemented by soups, relishes and sauces derived from vegetables, pulses, nuts or fish. The most important sources of dietary fat in African countries are oil crops (e.g. peanuts, soya beans) and cooking oils as red palm, peanut, coconut and sesame oils. Total fat intake in the majority of subSaharan countries is estimated to be in the range 30–60 g/person/day across the whole population (average 43 g/person/day). Breast-feeding of infants up to two years of age is standard, with one study estimating a fat intake of 15–30 g fat/day from breast milk up to the age of 18 months. Weaning foods typically contain low levels of fat, and the transition from breast milk to complete weaning is associated with a marked reduction in dietary fat. Nevertheless, fat intake >10 g/day has been reported in young children post-weaning. A randomized trial in Uganda reported no difference in the efficacy of AL between patients receiving supervised meals with a fixed fat content (~23 g fat) or taking AL unsupervised, suggesting that fat intake at home was sufficient for optimal efficacy. Moreover, randomized trials in African children aged 5–59 months have shown similar high cure rates to those observed

  14. The content of African diets is adequate to achieve optimal efficacy with fixed-dose artemether-lumefantrine: a review of the evidence.

    PubMed

    Premji, Zulfiqarali G; Abdulla, Salim; Ogutu, Bernhards; Ndong, Alice; Falade, Catherine O; Sagara, Issaka; Mulure, Nathan; Nwaiwu, Obiyo; Kokwaro, Gilbert

    2008-01-01

    A fixed-dose combination of artemether-lumefantrine (AL, Coartem(R)) has shown high efficacy, good tolerability and cost-effectiveness in adults and children with uncomplicated malaria caused by Plasmodium falciparum. Lumefantrine bioavailability is enhanced by food, particularly fat.As the fat content of sub-Saharan African meals is approximately a third that of Western countries, it raises the question of whether fat consumption by African patients is sufficient for good efficacy. Data from healthy volunteers have indicated that drinking 36 mL soya milk (containing only 1.2 g of fat) results in 90% of the lumefantrine absorption obtained with 500 mL milk (16 g fat). African diets are typically based on a carbohydrate staple (starchy root vegetables, fruit [plantain] or cereals) supplemented by soups, relishes and sauces derived from vegetables, pulses, nuts or fish. The most important sources of dietary fat in African countries are oil crops (e.g. peanuts, soya beans) and cooking oils as red palm, peanut, coconut and sesame oils. Total fat intake in the majority of subSaharan countries is estimated to be in the range 30-60 g/person/day across the whole population (average 43 g/person/day). Breast-feeding of infants up to two years of age is standard, with one study estimating a fat intake of 15-30 g fat/day from breast milk up to the age of 18 months. Weaning foods typically contain low levels of fat, and the transition from breast milk to complete weaning is associated with a marked reduction in dietary fat. Nevertheless, fat intake >10 g/day has been reported in young children post-weaning. A randomized trial in Uganda reported no difference in the efficacy of AL between patients receiving supervised meals with a fixed fat content (~23 g fat) or taking AL unsupervised, suggesting that fat intake at home was sufficient for optimal efficacy. Moreover, randomized trials in African children aged 5-59 months have shown similar high cure rates to those observed in

  15. A Framework for Designing Cluster Randomized Trials with Binary Outcomes

    ERIC Educational Resources Information Center

    Spybrook, Jessaca; Martinez, Andres

    2011-01-01

    The purpose of this paper is to provide a frame work for approaching a power analysis for a CRT (cluster randomized trial) with a binary outcome. The authors suggest a framework in the context of a simple CRT and then extend it to a blocked design, or a multi-site cluster randomized trial (MSCRT). The framework is based on proportions, an…

  16. 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. PMID:20674592

  17. Biomarkers for Alzheimer's disease therapeutic trials.

    PubMed

    Hampel, Harald; Wilcock, Gordon; Andrieu, Sandrine; Aisen, Paul; Blennow, Kaj; Broich, K; Carrillo, Maria; Fox, Nick C; Frisoni, Giovanni B; Isaac, Maria; Lovestone, Simon; Nordberg, Agneta; Prvulovic, David; Sampaio, Christina; Scheltens, Philip; Weiner, Michael; Winblad, Bengt; Coley, Nicola; Vellas, Bruno

    2011-12-01

    The development of disease-modifying treatments for Alzheimer's disease requires innovative trials with large numbers of subjects and long observation periods. The use of blood, cerebrospinal fluid or neuroimaging biomarkers is critical for the demonstration of disease-modifying therapy effects on the brain. Suitable biomarkers are those which reflect the progression of AD related molecular mechanisms and neuropathology, including amyloidogenic processing and aggregation, hyperphosphorylation, accumulation of tau and neurofibrillary tangles, progressive functional, metabolic and structural decline, leading to neurodegeneration, loss of brain tissue and cognitive symptoms. Biomarkers should be used throughout clinical trial phases I-III of AD drug development. They can be used to enhance inclusion and exclusion criteria, or as baseline predictors to increase the statistical power of trials. Validated and qualified biomarkers may be used as outcome measures to detect treatment effects in pivotal clinical trials. Finally, biomarkers can be used to identify adverse effects. Questions regarding which biomarkers should be used in clinical trials, and how, are currently far from resolved. The Oxford Task Force continues and expands the work of our previous international expert task forces on disease-modifying trials and on endpoints for Alzheimer's disease clinical trials. The aim of this initiative was to bring together a selected number of key international opinion leaders and experts from academia, regulatory agencies and industry to condense the current knowledge and state of the art regarding the best use of biological markers in Alzheimer's disease therapy trials and to propose practical recommendations for the planning of future AD trials. PMID:21130138

  18. 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

  19. Adequate iodine levels in healthy pregnant women. A cross-sectional survey of dietary intake in Turkey

    PubMed Central

    Kasap, Burcu; Akbaba, Gülhan; Yeniçeri, Emine N.; Akın, Melike N.; Akbaba, Eren; Öner, Gökalp; Turhan, Nilgün Ö.; Duru, Mehmet E.

    2016-01-01

    Objectives: To assess current iodine levels and related factors among healthy pregnant women. Methods: In this cross-sectional, hospital-based study, healthy pregnant women (n=135) were scanned for thyroid volume, provided urine samples for urinary iodine concentration and completed a questionnaire including sociodemographic characteristics and dietary habits targeted for iodine consumption at the Department of Obstetrics and Gynecology, School of Medicine, Muğla Sıtkı Koçman University, Muğla, Turkey, between August 2014 and February 2015. Sociodemographic data were analyzed by simple descriptive statistics. Results: Median urinary iodine concentration was 222.0 µg/L, indicating adequate iodine intake during pregnancy. According to World Health Organization (WHO) criteria, 28.1% of subjects had iodine deficiency, 34.1% had adequate iodine intake, 34.8% had more than adequate iodine intake, and 3.0% had excessive iodine intake during pregnancy. Education level, higher monthly income, current employment, consuming iodized salt, and adding salt to food during, or after cooking were associated with higher urinary iodine concentration. Conclusion: Iodine status of healthy pregnant women was adequate, although the percentage of women with more than adequate iodine intake was higher than the reported literature. PMID:27279519

  20. 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.

  1. ClinicalTrials.gov | NIH MedlinePlus the Magazine

    MedlinePlus

    ... of Contents “...a powerful tool for the healthcare consumer” Clinical trials are research studies that use volunteers to help medical professionals test new treatments for a wide array of diseases and ...

  2. 17-Hydroxyprogesterone caproate to prolong pregnancy after preterm rupture of the membranes: early termination of a double-blind, randomized clinical trial

    PubMed Central

    2011-01-01

    Background Progestational agents may reduce the risk of preterm birth in women with various risk factors. We sought to test the hypothesis that a weekly dose of 17-hydroxyprogesterone caproate (17P) given to women with preterm rupture of the membranes (PROM) will prolong pregnancy and thereby reduce neonatal morbidity. Methods Double-blind, placebo-controlled randomized clinical trial. Women with PROM at 23.0 to 31.9 weeks of gestation were randomly assigned to receive a weekly intramuscular injection of 17P (250 mg in 1 mL castor oil) or placebo (1 mL castor oil). The primary outcome was the rate of continuing the pregnancy until 34.0 weeks of gestation or until documentation of fetal lung maturity at 32.0 to 33.9 weeks of gestation. Planned secondary outcomes were duration of latency period and rate of composite neonatal morbidity. Enrollment of 111 participants per group, 222 total, was planned to yield 80% power to detect an increase in the primary outcome from 30% with placebo to 50% with 17P. Results Twelve women were enrolled of whom 4 were randomly assigned to receive 17P and 8 to receive placebo. The trial was terminated prematurely because of two separate issues related to the supply of 17P. No adverse events attributable to 17P were identified. Conclusion Because of premature termination, the trial does not have adequate statistical power to evaluate efficacy or safety of 17P in women with PROM. Nonetheless, ethical principles dictate that we report the results, which may contribute to possible future metaanalyses and systematic reviews. Trial Registration ClinicalTrials.gov: NCT01119963 Supported by a research grant from the Center for Research, Education, and Quality, Pediatrix Medical Group, Sunrise, FL PMID:22206581

  3. Antidepressant Controlled Trial For Negative Symptoms In Schizophrenia (ACTIONS): a double-blind, placebo-controlled, randomised clinical trial.

    PubMed Central

    Barnes, Thomas Re; Leeson, Verity C; Paton, Carol; Costelloe, Céire; Simon, Judit; Kiss, Noemi; Osborn, David; Killaspy, Helen; Craig, Tom Kj; Lewis, Shôn; Keown, Patrick; Ismail, Shajahan; Crawford, Mike; Baldwin, David; Lewis, Glyn; Geddes, John; Kumar, Manoj; Pathak, Rudresh; Taylor, Simon

    2016-01-01

    were no statistically significant differences between the two treatment arms over 48-week follow-up in either the health economics outcomes or costs, and no differences in the frequency or severity of adverse effects, including corrected QT interval prolongation. LIMITATIONS The trial under-recruited, partly because cardiac safety concerns about citalopram were raised, with the 62 participants recruited falling well short of the target recruitment of 358. Although this was the largest sample randomised to citalopram in a randomised controlled trial of antidepressant augmentation for negative symptoms of schizophrenia and had the longest follow-up, the power of statistical analysis to detect significant differences between the active and placebo groups was limited. CONCLUSION Although adjunctive citalopram did not improve negative symptoms overall, there was evidence of some positive effect on avolition/amotivation, recognised as a critical barrier to psychosocial rehabilitation and achieving better social and community functional outcomes. Comprehensive assessment of side-effect burden did not identify any serious safety or tolerability issues. The addition of citalopram as a long-term prescribing strategy for the treatment of negative symptoms may merit further investigation in larger studies. FUTURE WORK Further studies of the viability of adjunctive antidepressant treatment for negative symptoms in schizophrenia should include appropriate safety monitoring and use rating scales that allow for evaluation of avolition/amotivation as a discrete negative symptom domain. Overcoming the barriers to recruiting an adequate sample size will remain a challenge. TRIAL REGISTRATION European Union Drug Regulating Authorities Clinical Trials (EudraCT) number 2009-009235-30 and Current Controlled Trials ISRCTN42305247. FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 29

  4. [The pregnant employee in anaesthesia and intensive care - An evidence-based approach to designing adequate workplaces].

    PubMed

    Röher, Katharina; Göpfert, Matthias S

    2015-07-01

    In the light of a rising percentage of women among employees in anaesthesia and intensive care designing adequate workplaces for pregnant employees plays an increasingly important role. Here it is necessary to align the varied interests of the pregnant employee, fellow employees and the employer, where the legal requirements of the Maternity Protection Act ("Mutterschutzgesetz") form the statutory framework. This review describes how adequate workplaces for pregnant employees in anaesthesia and intensive care can be established considering the scientific evidence on the subject. PMID:26230896

  5. Three not adequately understood lunar phenomena investigated by the wave planetology

    NASA Astrophysics Data System (ADS)

    Kochemasov, G. G.

    2009-04-01

    Three not adequately understood lunar phenomena investigated by the wave planetology G. Kochemasov IGEM of the Russian Academy of Sciences, Moscow, Russia, kochem.36@mail.ru The lunar science notwithstanding rather numerous researches of the last 50 years still debates some important issues. Three of them concern an origin of mascons, the deepest but low ferruginous South Pole-Aitken depression, a strange character of the frequency-crater size curve. Prevailing approaches are mainly based on impacts having made the present geomorphology of the Moon. However practically are ignored the fact of antipodality of basins and marea, a complex character of the frequency-crater size curve obviously implying an involvement of different sources and reasons responsible for crater formation. Attempts to find impactor sources in various sometimes very remote parts of the Solar system are too artificial, besides they do not explain very intensive, like lunar cratering of Mercury. Saturation of the lunar surface by ~70-km diameter craters is very strange for random impacts from any source; to find a time interval for this saturation is difficult if not possible because it affects formations of various ages. Lunar basins and marea completely contradict to a classical frequency- crater size curve. Their presumed ( and measured) different ages make dubious existence of one specialized impactor source. So, if one accepts an impact process as the only process responsible for cratering (ring forms development) then the real mess in crater statistics and timing never will be overcome. The wave planetology [1-3 & others] examined by many planets and satellites of the Solar system proved to be real. In a case of the Moon it can help in answering the above questions. First of all it should be admitted that the complex lunar crater (ring forms) statistics is due to a superposition and mixing of two main processes (a minor involvement of volcanic features is also present): impacts and wave

  6. Using Clinical Trial Simulators to Analyse the Sources of Variance in Clinical Trials of Novel Therapies for Acute Viral Infections

    PubMed Central

    Weverling, Gerrit-Jan; de Wolf, Frank; Anderson, Roy M.

    2016-01-01

    Background About 90% of drugs fail in clinical development. The question is whether trials fail because of insufficient efficacy of the new treatment, or rather because of poor trial design that is unable to detect the true efficacy. The variance of the measured endpoints is a major, largely underestimated source of uncertainty in clinical trial design, particularly in acute viral infections. We use a clinical trial simulator to demonstrate how a thorough consideration of the variability inherent in clinical trials of novel therapies for acute viral infections can improve trial design. Methods and Findings We developed a clinical trial simulator to analyse the impact of three different types of variation on the outcome of a challenge study of influenza treatments for infected patients, including individual patient variability in the response to the drug, the variance of the measurement procedure, and the variance of the lower limit of quantification of endpoint measurements. In addition, we investigated the impact of protocol variation on clinical trial outcome. We found that the greatest source of variance was inter-individual variability in the natural course of infection. Running a larger phase II study can save up to $38 million, if an unlikely to succeed phase III trial is avoided. In addition, low-sensitivity viral load assays can lead to falsely negative trial outcomes. Conclusions Due to high inter-individual variability in natural infection, the most important variable in clinical trial design for challenge studies of potential novel influenza treatments is the number of participants. 100 participants are preferable over 50. Using more sensitive viral load assays increases the probability of a positive trial outcome, but may in some circumstances lead to false positive outcomes. Clinical trial simulations are powerful tools to identify the most important sources of variance in clinical trials and thereby help improve trial design. PMID:27332704

  7. CLINICAL TRIALS.GOV

    EPA Science Inventory

    ClinicalTrials.gov provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. The U.S. National Institutes of Health (NIH), through its National Library of Medi...

  8. Bias from industry trial funding? A framework, a suggested approach, and a negative result.

    PubMed

    Barden, Jodie; Derry, Sheena; McQuay, Henry J; Moore, R Andrew

    2006-04-01

    Bias from funding sources of trials would threaten their validity. Meta-analyses of high quality acute pain and migraine trials were used to explore the hypothesis that industry funding of clinical trials produced more favourable results than non-profit sponsorship. Analyses were planned to evaluate whether industry-sponsored trials had different results from trials funded by academic or other non-profit sources, but of 176 trials, only two were supported by non-profit sources, while 31 provided no statement of support. An alternative method is proposed within industry-sponsored trials, looking at conflicting industry interests for the same drug, used either as test or comparator treatment. Fifty-three trials used an analgesic as test and 90 as comparator, allowing comparisons to be made for aspirin 600/650 mg, ibuprofen 400 mg, paracetamol (acetaminophen) 1000 mg, rofecoxib 50 mg and sumatriptan 50 and 100 mg. Only for sumatriptan 50 and 100 mg, with the outcome of headache response at 2 h, was there any significant difference between the drug used as a test or as a comparator. The direction was for higher (worse) NNTs with sumatriptan as comparator. Investigating potential industry bias through the funding source of trials is unlikely to be adequate because of a dearth of trials funded by non-profit organisations. We propose a method based on potential conflict of interest within industry-sponsored trials. Using this method, established clinical trial results in acute pain and migraine appear to be unbiased. PMID:16495012

  9. 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

  10. 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...

  11. 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. PMID:25315593

  12. 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

  13. Controlled Trials in Children: Quantity, Methodological Quality and Descriptive Characteristics of Pediatric Controlled Trials Published 1948-2006

    PubMed Central

    Thomson, Denise; Hartling, Lisa; Cohen, Eyal; Vandermeer, Ben; Tjosvold, Lisa; Klassen, Terry P.

    2010-01-01

    Background The objective of this study was to describe randomized controlled trials (RCTs) and controlled clinical trials (CCTs) in child health published between 1948 and 2006, in terms of quantity, methodological quality, and publication and trial characteristics. We used the Trials Register of the Cochrane Child Health Field for overall trends and a sample from this to explore trial characteristics in more detail. Methodology/Principal Findings We extracted descriptive data on a random sample of 578 trials. Ninety-six percent of the trials were published in English; the percentage of child-only trials was 90.5%. The most frequent diagnostic categories were infectious diseases (13.2%), behavioural and psychiatric disorders (11.6%), neonatal critical care (11.4%), respiratory disorders (8.9%), non-critical neonatology (7.9%), and anaesthesia (6.5%). There were significantly fewer child-only studies (i.e., more mixed child and adult studies) over time (P = 0.0460). The proportion of RCTs to CCTs increased significantly over time (P<0.0001), as did the proportion of multicentre trials (P = 0.002). Significant increases over time were found in methodological quality (Jadad score) (P<0.0001), the proportion of double-blind studies (P<0.0001), and studies with adequate allocation concealment (P<0.0001). Additionally, we found an improvement in reporting over time: adequate description of withdrawals and losses to follow-up (P<0.0001), sample size calculations (P<0.0001), and intention-to-treat analysis (P<0.0001). However, many trials still do not describe their level of blinding, and allocation concealment was inadequately reported in the majority of studies across the entire time period. The proportion of studies with industry funding decreased slightly over time (P = 0.003), and these studies were more likely to report positive conclusions (P = 0.028). Conclusions/Significance The quantity and quality of pediatric controlled trials has increased over

  14. 21 CFR 1.283 - What happens to food that is imported or offered for import without adequate prior notice?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... dealt with as set forth in CBP regulations relating to general order merchandise (19 CFR part 127... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What happens to food that is imported or offered for import without adequate prior notice? 1.283 Section 1.283 Food and Drugs FOOD AND...

  15. 21 CFR 1.284 - What are the other consequences of failing to submit adequate prior notice or otherwise failing...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What are the other consequences of failing to submit adequate prior notice or otherwise failing to comply with this subpart? 1.284 Section 1.284 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...

  16. 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…

  17. 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…

  18. 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. …

  19. Students' Use of Tutoring Services, by Adequate Yearly Progress Status of School. Statistics in Brief. NCES 2010-023

    ERIC Educational Resources Information Center

    Warkentien, Siri; Grady, Sarah

    2009-01-01

    This Statistics in Brief contributes to current research by investigating the use of tutoring services among a nationally representative group of public school students enrolled in grades K-12. The report compares students in schools that have not made Adequate Yearly Progress (AYP) for 3 or more years, and were thereby enrolled in schools that…

  20. 33 CFR 151.2065 - What is the standard of adequate compliance determined by the ANSTF for this subpart? [Reserved

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false What is the standard of adequate... Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) POLLUTION VESSELS CARRYING OIL, NOXIOUS LIQUID SUBSTANCES, GARBAGE, MUNICIPAL OR COMMERCIAL WASTE, AND BALLAST WATER Ballast Water Management...

  1. Iodine Status of Women of Reproductive Age in Sierra Leone and Its Association with Household Coverage with Adequately Iodized Salt

    PubMed Central

    Rohner, Fabian; Wirth, James P.; Woodruff, Bradley A.; Chiwile, Faraja; Yankson, Hannah; Sesay, Fatmata; Koroma, Aminata S.; Petry, Nicolai; Pyne-Bailey, Solade; Dominguez, Elisa; Kupka, Roland; Hodges, Mary H.; de Onis, Mercedes

    2016-01-01

    Salt iodization programs are a public health success in tackling iodine deficiency. Yet, a large proportion of the world’s population remains at risk for iodine deficiency. In a nationally representative cross-sectional survey in Sierra Leone, household salt samples and women’s urine samples were quantitatively analyzed for iodine content. Salt was collected from 1123 households, and urine samples from 817 non-pregnant and 154 pregnant women. Household coverage with adequately iodized salt (≥15 mg/kg iodine) was 80.7%. The median urinary iodine concentration (UIC) of pregnant women was 175.8 µg/L and of non-pregnant women 190.8 µg/L. Women living in households with adequately iodized salt had higher median UIC (for pregnant women: 180.6 µg/L vs. 100.8 µg/L, respectively, p < 0.05; and for non-pregnant women: 211.3 µg/L vs. 97.8 µg/L, p < 0.001). Differences in UIC by residence, region, household wealth, and women’s education were much smaller in women living in households with adequately iodized salt than in households without. Despite the high household coverage of iodized salt in Sierra Leone, it is important to reach the 20% of households not consuming adequately iodized salt. Salt iodization has the potential for increasing equity in iodine status even with the persistence of other risk factors for deficiency. PMID:26848685

  2. Iodine Status of Women of Reproductive Age in Sierra Leone and Its Association with Household Coverage with Adequately Iodized Salt.

    PubMed

    Rohner, Fabian; Wirth, James P; Woodruff, Bradley A; Chiwile, Faraja; Yankson, Hannah; Sesay, Fatmata; Koroma, Aminata S; Petry, Nicolai; Pyne-Bailey, Solade; Dominguez, Elisa; Kupka, Roland; Hodges, Mary H; de Onis, Mercedes

    2016-02-01

    Salt iodization programs are a public health success in tackling iodine deficiency. Yet, a large proportion of the world's population remains at risk for iodine deficiency. In a nationally representative cross-sectional survey in Sierra Leone, household salt samples and women's urine samples were quantitatively analyzed for iodine content. Salt was collected from 1123 households, and urine samples from 817 non-pregnant and 154 pregnant women. Household coverage with adequately iodized salt (≥15 mg/kg iodine) was 80.7%. The median urinary iodine concentration (UIC) of pregnant women was 175.8 µg/L and of non-pregnant women 190.8 µg/L. Women living in households with adequately iodized salt had higher median UIC (for pregnant women: 180.6 µg/L vs. 100.8 µg/L, respectively, p < 0.05; and for non-pregnant women: 211.3 µg/L vs. 97.8 µg/L, p < 0.001). Differences in UIC by residence, region, household wealth, and women's education were much smaller in women living in households with adequately iodized salt than in households without. Despite the high household coverage of iodized salt in Sierra Leone, it is important to reach the 20% of households not consuming adequately iodized salt. Salt iodization has the potential for increasing equity in iodine status even with the persistence of other risk factors for deficiency. PMID:26848685

  3. Funding an Adequate Education for America's Youth: A Plan for Melding Political and Market Definitions of Educational Adequacy.

    ERIC Educational Resources Information Center

    Guthrie, James W.

    Noting that American society has conventionally relied on both the political process and the marketplace to arrive at a "definition" of adequate education, but that the political process fails to account for individual preferences while the marketplace can cater to many individual preferences, this paper attempts to combine the two processes in a…

  4. 36 CFR 79.9 - Standards to determine when a repository possesses the capability to provide adequate long-term...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 36 Parks, Forests, and Public Property 1 2013-07-01 2013-07-01 false Standards to determine when a repository possesses the capability to provide adequate long-term curatorial services. 79.9 Section 79.9 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR CURATION OF FEDERALLY-OWNED AND...

  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. 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 National…

  7. Stem cell trials for cardiovascular medicine: ethical rationale.

    PubMed

    Niemansburg, Sophie L; Teraa, Martin; Hesam, Husna; van Delden, Johannes J M; Verhaar, Marianne C; Bredenoord, Annelien L

    2014-10-01

    Stem cell-based interventions provide new treatment prospects for many disease conditions, including cardiovascular disorders. Clinical trials are necessary to collect adequate evidence on (long-term) safety and efficacy of novel interventions such as stem cells, but the design and launch of clinical trials, from first-in-human studies to larger randomized controlled trials (RCTs), is scientifically and ethically challenging. Stem cells are different from traditional pharmaceuticals, surgical procedures, and medical devices in the following ways: the novelty and complexity of stem cells, the invasiveness of the procedures, and the novel aim of regeneration. These specifics, combined with the characteristics of the study population, will have an impact on the design and ethics of RCTs. The recently closed JUVENTAS trial will serve as an example to identify the (interwoven) scientific and ethical challenges in the design and launch of stem cell RCTs. The JUVENTAS trial has investigated the efficacy of autologous bone marrow cells in end-stage vascular patients, in a double-blind sham-controlled design. We first describe the choices, considerations, and experiences of the JUVENTAS team. Subsequently, we identify the main ethical and scientific challenges and discuss what is important to consider in the design of future stem cell RCTs: assessment of risks and benefits, the choice for outcome measures, the choice for the comparator, the appropriate selection of participants, and adequate informed consent. Additionally, the stem cell field is highly in the spotlight due to the (commercial) interests and expectations. This warrants a cautious pace of translation and scrupulous set up of clinical trials, as failures could put the field in a negative light. At the same time, knowledge from clinical trials is necessary for the field to progress. We conclude that in the scientifically and ethically challenging field of stem cell RCTs, researchers and clinicians have to

  8. 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

  9. Cognitive Behavioural Suicide Prevention for Male Prisoners: A pilot randomised controlled trial

    PubMed Central

    Pratt, D.; Tarrier, N.; Dunn, G.; Awenat, Y.; Shaw, J.; Ulph, F.; Gooding, P.

    2015-01-01

    Background Prisoners have an exceptional risk of suicide. Cognitive behavioural therapy for suicidal behaviour has been shown to offer considerable potential, but has yet to be formally evaluated within prisons. This study investigated the feasibility of delivering and evaluating a novel, manualised cognitive behavioural suicide prevention (CBSP) therapy for suicidal male prisoners. Methods A pilot randomised controlled trial of CBSP in addition to treatment as usual (CBSP; n=31) compared to treatment as usual alone (TAU; n=31), was conducted in a male prison in England. The primary outcome was self-injurious behaviour occurring within the past six months. Secondary outcomes were dimensions of suicidal ideation, psychiatric symptomatology, personality dysfunction and psychological determinants of suicide, including depression and hopelessness. The trial was prospectively registered (number ISRCTN59909209). Results Relative to TAU, participants receiving CBSP therapy achieved a significantly greater reduction in suicidal behaviours with a moderate treatment effect (Cohen’s d=−0.72, 95%CI: −1.71 to 0.09; baseline mean [SD], TAU: 1.39[3.28] vs CBSP: 1.06[2.10], 6 months mean [SD], TAU: 1.48[3.23] vs CBSP: 0.58[1.52]). Significant improvements were achieved on measures of psychiatric symptomatology and personality dysfunction. Improvements on psychological determinants of suicide were non-significant. More than half of participants in the CBSP group achieved a clinically significant recovery by the end of therapy, compared to a quarter of the TAU group. Conclusions The delivery and evaluation of cognitive behavioural suicide prevention therapy within a prison is feasible. CBSP therapy offers significant promise in the prevention of prison suicide and an adequately powered randomised controlled trial is warranted. PMID:26165919

  10. Shuffling Adaptive Clinical Trials.

    PubMed

    Gokhale, Sanjay G; Gokhale, Sankalp

    2016-01-01

    Clinical trials are interventional studies on human beings, designed to test the hypothesis for diagnostic techniques, treatments, and disease preventions. Any novel medical technology should be evaluated for its efficacy and safety by clinical trials. The costs associated with developing drugs have increased dramatically over the past decade, and fewer drugs are obtaining regulatory approval. Because of this, the pharmaceutical industry is continually exploring new ways of improving drug developments, and one area of focus is adaptive clinical trial designs. Adaptive designs, which allow for some types of prospectively planned mid-study changes, can improve the efficiency of a trial and maximize the chance of success without undermining validity and integrity of the trial. However it is felt that in adaptive trials; perhaps by using accrued data the actual patient population after the adaptations could deviate from the originally target patient population and so to overcome this drawback; special methods like Bayesian Statistics, predicted probability are used to deduce data-analysis. Here, in this study, mathematical model of a new adaptive design (shuffling adaptive trial) is suggested which uses real-time data, and because there is no gap between expected and observed data, statistical modifications are not needed. Results are obviously clinically relevant. PMID:23751329

  11. 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. PMID:25732246

  12. Inept media trials of clinical trials

    PubMed Central

    Ramamurthy, N. V.

    2012-01-01

    The Indian media in general, with the exception of a few domain expert journalists, have failed to comprehend the complexities involved in the clinical trial process. In the run up to the deadline-based coverage of a story, a majority of them fall short in conveying the right perspective to readers, but nevertheless they have been successful in sensationalizing an event in this arena. Possibly by unintended misrepresentation, or mostly out of ignorance of the nuances involved in the clinical trials process, the media has done more harm than good, and got away with it. On the other side, the industry has been reluctant to engage with the media in a meaningful dialog for too long now. It bears not only the consequences of damage to its professional reputation following such reportage, but also the repercussions of unnecessary clampdowns by the regulators. Science journalism in India has yet to rise as a profession. PMID:22701819

  13. 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

  14. The Perfect Clinical Trial.

    PubMed

    Bril, V

    2016-01-01

    Multiple phase III clinical trials have failed to show disease-modifying benefits for diabetic sensorimotor polyneuropathy (DSP) and this may be due to the design of the clinical trials. The perfect clinical trial in DSP would enroll sufficiently large numbers of patients having early or minimal disease, as demonstrated by nerve conduction studies (NCS). These patients would be treated with an intervention given at an effective and well-tolerated dose for a sufficient duration of time to show change in the end points selected. For objective or surrogate measures such as NCS and for some small fiber measures, the duration needed to show positive change may be as brief as 6-12 months, but subsequently, trials lasting 5-8 years will be required to demonstrate clinical benefits. PMID:27133143

  15. Clinical Trials - Participants

    MedlinePlus

    ... participating in was reviewed by an IRB. Further Reading For more information about research protections, see: Office ... data and decide whether the results have medical importance. Results from clinical trials are often published in ...

  16. 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.

  17. Participating in Clinical Trials

    MedlinePlus Videos and Cool Tools

    ... experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or prevent a disease. A clinical trial may compare experimental products or tests to those already available or may compare existing ...

  18. 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

  19. Internet-based randomized controlled trials: a systematic review

    PubMed Central

    Mathieu, Erin; McGeechan, Kevin; Barratt, Alexandra; Herbert, Robert

    2013-01-01

    Background The internet is increasingly being used to conduct randomized controlled trials (RCTs). Knowledge of the types of interventions evaluated and the methodological quality of these trials could inform decisions about whether to conduct future trials using conventional methods, fully online or a mixture of the two. Objective To identify and describe the scope of internet-based RCTs for human health condition interventions and evaluate their methodological quality. Methods A systematic review of RCTs of any health intervention conducted fully or primarily on the internet was carried out. Results 23 fully and 27 primarily internet-based RCTs were identified. The first was conducted in 2000. The majority of trials evaluated interventions that involved providing health information to participants, but a few evaluated self-administered interventions (eg, valerian, stretching). Methodological quality was variable and the methods were generally poorly reported. The risk of bias was low in only a small number of trials; most had substantial methodological shortcomings. Only one trial was identified as meeting all criteria for adequate methodological quality. A particular problem was high rates of loss to follow-up (fully online: mean 47%; primarily online: mean 36%). Conclusions It is theoretically possible but perhaps difficult to test the effectiveness of health interventions rigorously with RCTs conducted fully or primarily over the internet. The use of the internet to conduct trials is more suited to pragmatic rather than explanatory trials. The main limitation of these trials is that they typically experience high rates of loss to follow-up. Methodological standards now accepted for traditional RCTs needs to be evident for online RCTs as well, especially in reporting of their methods. PMID:23065196

  20. 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. PMID:23539700

  1. A feasibility study and pilot randomised trial of a tailored prevention program to reduce falls in older people with mild dementia

    PubMed Central

    2013-01-01

    carers. The lessons learnt included: recruitment for a larger trial will require multiple approaches; home safety recommendations should provide a greater emphasis on environmental use compared with behavioural change; strategies to ensure an adequate dosage of exercise should be further explored. We recommend that intervention delivery incorporate an integrated occupational therapy and physiotherapy approach and that carers be provided with an individualised session to enhance dementia-specific skills in management and communication. A refined intervention should be tested in a randomised trial with an adequately powered sample size. Trial registration Australia and New Zealand Clinical Trials Registry 126100001049066 PMID:24004682

  2. 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.

  3. 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

  4. 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.

  5. Placebo Effect in Clinical Trial Design for Irritable Bowel Syndrome

    PubMed Central

    Shah, Eric; Pimentel, Mark

    2014-01-01

    Ongoing efforts to improve clinical trial design in irritable bowel syndrome have been hindered by high placebo response rates and ineffective outcome measures. We assessed established strategies to minimize placebo effect as well as the various approaches to placebo effect which can affect trial design. These include genetic markers such as catechol-O-methyltransferase, opioidergic and dopaminergic neurobiologic theory, pre-cebo effect centered on expectancy theory, and side effect unblinding grounded on conditioning theory. We reviewed endpoints used in the study of IBS over the past decade including adequate relief and subjective global relief, emphasizing their weaknesses in fully evaluating the IBS condition, specifically their motility effects based on functional net value and relative benefit-harm based on dropouts due to adverse events. The focus of this review is to highlight ongoing efforts to improve clinical trial design which can lead to better outcomes in a real-world setting. PMID:24840369

  6. Clinical Trials in Rare Disease: Challenges and Opportunities

    PubMed Central

    Augustine, Erika F.; Adams, Heather R.; Mink, Jonathan W.

    2014-01-01

    The neuronal ceroid lipofuscinoses constitute one of many groups of rare childhood diseases for which disease-modifying treatments are non-existent. Disease-specific barriers to therapeutic success include incomplete understanding of disease pathophysiology and limitations of treatments that cannot adequately cross the blood-brain barrier to access the central nervous system. Therapeutic development in the neuronal ceroid lipofuscinoses shares many challenges with other rare diseases, such as incomplete understanding of natural history to inform trial design, need for alternatives to the randomized controlled clinical trial, requirement for more sensitive outcome measures to quantify disease, limited access to resources required to mount a clinical trial (including funding), and difficulties of recruiting a small sample to participation. Solutions to these barriers will require multicenter collaboration, partnership with patient organizations, training a new generation of researchers interested in rare diseases, and leveraging existing resources. PMID:24014509

  7. A model for determining when an analysis contains sufficient detail to provide adequate NEPA coverage for a proposed action

    SciTech Connect

    Eccleston, C.H.

    1994-11-01

    Neither the National Environmental Policy Act (NEPA) nor its subsequent regulations provide substantive guidance for determining the Level of detail, discussion, and analysis that is sufficient to adequately cover a proposed action. Yet, decisionmakers are routinely confronted with the problem of making such determinations. Experience has shown that no two decisionmakers are Likely to completely agree on the amount of discussion that is sufficient to adequately cover a proposed action. one decisionmaker may determine that a certain Level of analysis is adequate, while another may conclude the exact opposite. Achieving a consensus within the agency and among the public can be problematic. Lacking definitive guidance, decisionmakers and critics alike may point to a universe of potential factors as the basis for defending their claim that an action is or is not adequately covered. Experience indicates that assertions are often based on ambiguous opinions that can be neither proved nor disproved. Lack of definitive guidance slows the decisionmaking process and can result in project delays. Furthermore, it can also Lead to inconsistencies in decisionmaking, inappropriate Levels of NEPA documentation, and increased risk of a project being challenged for inadequate coverage. A more systematic and less subjective approach for making such determinations is obviously needed. A paradigm for reducing the degree of subjectivity inherent in such decisions is presented in the following paper. The model is specifically designed to expedite the decisionmaking process by providing a systematic approach for making these determination. In many cases, agencies may find that using this model can reduce the analysis and size of NEPA documents.

  8. Continued vorapaxar versus withdrawed clopidogrel both on top of low dose aspirin in patients undergoing heart surgery: A call for randomized trial.

    PubMed

    Serebruany, Victor L; Kim, Moo Hyun; Golukhova, Elena; Pya, Yury; Bekbossynova, Makhabbat; Cattaneo, Marco; Marciniak, Thomas A

    2016-07-15

    Despite advanced techniques and improved clinical outcomes, the optimal antiplatelet strategy following coronary artery bypass grafting (CABG) is an unsolved mystery. Vorapaxar, a novel platelet thrombin receptor (PAR-1/4) blocker, is currently approved for post-myocardial infarction and peripheral artery disease indications on top of clopidogrel or/and aspirin. We here summarize the outcomes in patients after CABG for justification of a future vorapaxar trial. We comprehended the CABG outcomes after vorapaxar yielded from TRACER, TRA2P trials, and affiliated FDA reviews. The verified evidence suggests that composite of death, myocardial infarction and stroke occurred in 2.2% of vorapaxar vs. 8.1% placebo in TRA2P. These data were similar to the endpoint differences (5.9% after vorapaxar vs. 8.3% for placebo) in TRACER. The mortality reduction also consistently suggests vorapaxar advantage (1.7% vs. 2.5% in TRA2P, and 1.7% vs. 3.9% in TRACER). Notably, the post-CABG bleeding risks after vorapaxar were only slightly, but not significantly higher. Moreover, the bleeding disadvantage in the experimental arm was most likely related to overtreatment since majority of patients in both TRACER and TRA2P received triple antiplatelet therapy with aspirin, clopidogrel on top of vorapaxar. Overall, the FDA-confirmed evidence advocate for the future vorapaxar post-CABG outcome-driven trial. The head-to-head trial testing dual therapy with continued over CABG vorapaxar versus withdrawed clopidogrel, both on top of low dose aspirin is warranted. We conclude that the primary outcomes including mortality were consistently better for heart surgery patients after vorapaxar, while the excess of bleeding was mild. Continuing vorapaxar during CABG may be superior to currently recommended withdrawal antiplatelet strategies, and should be tested in an adequately powered randomized outcome-driven trial. PMID:27128545

  9. 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

  10. Probiotics for Preventing Late-Onset Sepsis in Preterm Neonates: A PRISMA-Compliant Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Zhang, Guo-Qiang; Hu, Hua-Jian; Liu, Chuan-Yang; Shakya, Shristi; Li, Zhong-Yue

    2016-02-01

    The effect of probiotics on late-onset sepsis (LOS) in preterm neonates remains controversial. The authors systematically reviewed the literature to investigate whether enteral probiotic supplementation reduced the risk of LOS in preterm neonates in neonatal intensive care units.PubMed, Embase, and Cochrane Central Register of Controlled Trials were systematically searched for randomized controlled trials (RCTs) regarding the effect of probiotics in preterm neonates. The primary outcome was culture-proven bacterial and/or fungal sepsis. The Mantel-Haenszel method with random-effects model was used to calculate pooled relative risks (RRs) and 95% confidence intervals (CIs).Twenty-seven trials were included in our review, and 25 trials involving 6104 preterm neonates were statistically analyzed. Pooled analysis indicated that enteral probiotic supplementation significantly reduced the risk of any sepsis (25 RCTs; RR 0.83, 95% CI 0.73-0.94; I = 26%), bacterial sepsis (11 RCTs; RR 0.82, 95% CI 0.71-0.95; I = 0%), and fungal sepsis (6 RCTs; RR 0.57, 95% CI 0.41-0.78; I = 0%). This beneficial effect remains in very low birth weight infants (<1500 g) (19 RCTs; RR 0.86, 95% CI 0.75-0.97; I = 18%), but not in extremely low birth weight infants (<1000 g) (3 RCTs; RR 0.73, 95% CI 0.45-1.19; I = 53%). All the included trials reported no systemic infection caused by the supplemental probiotic organisms.Current evidence indicates that probiotic supplementation is safe, and effective in reducing the risk of LOS in preterm neonates in neonatal intensive care units. Further studies are needed to address the optimal probiotic organism, dosing, timing, and duration. High-quality and adequately powered RCTs regarding the efficacy and safety of the use of probiotics in extremely low birth weight infants are still warranted. PMID:26937897

  11. Adjuvant therapy with minocycline for schizophrenia (The MINOS Trial): study protocol for a double-blind randomized placebo-controlled trial

    PubMed Central

    2013-01-01

    Background Schizophrenia is understood to be a heterogeneous brain condition with overlapping symptom dimensions. The negative symptom dimension, with its protean cognitive manifestations, responds poorly to treatment, which can be a particular challenge in countries where clozapine therapy is not available. Preliminary data indicate that minocycline may be beneficial adjunct in the treatment of schizophrenia: positive, negative, and cognitive symptoms. In this study we aim to assess the efficacy of adjunctive minocycline to alleviate symptoms of schizophrenia in patients who have failed to respond to a therapeutic trial of antipsychotic medications. Methods The study is a parallel group, double-blind, randomized, placebo-controlled trial. Participants will be adults (aged 18 years and above) with first episode or relapse episode of schizophrenia of under 5 years’ duration. Patients who failed to show adequate therapeutic response to at least one antipsychotic medication given for a minimum of 4 weeks will be recruited from a psychiatry hospital in Addis Ababa and a psychiatry clinic in Butajira, Ethiopia. A total of 150 participants (75 in each arm) will be required to detect a five-point mean difference between the intervention arms adjusting for baseline symptom severity, at 90% power and 95% confidence. Patients in the intervention arm will receive minocycline (200 mg/day orally) added on to the regular antipsychotic medications participants are already on. Those in the placebo arm will receive an inactive compound identical in physical appearance to minocycline. Intervention will be offered for 12 weeks. Diagnosis will be established using the operational criteria for research (OPCRIT). Primary outcome measure will be a change in symptom severity measured using the positive and the negative syndrome scale for schizophrenia (PANSS). Secondary outcome measures will include changes in severity of negative symptoms, proportion achieving remission, and level

  12. 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. PMID:23832963

  13. 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

  14. 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. PMID:24387700

  15. Searching ClinicalTrials.gov and the International Clinical Trials Registry Platform to inform systematic reviews: what are the optimal search approaches?*

    PubMed Central

    Glanville, Julie M.; Duffy, Steven; McCool, Rachael; Varley, Danielle

    2014-01-01

    Background: Since 2005, International Committee of Medical Journal Editors (ICMJE) member journals have required that clinical trials be registered in publicly available trials registers before they are considered for publication. Objectives: The research explores whether it is adequate, when searching to inform systematic reviews, to search for relevant clinical trials using only public trials registers and to identify the optimal search approaches in trials registers. Methods: A search was conducted in ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP) for research studies that had been included in eight systematic reviews. Four search approaches (highly sensitive, sensitive, precise, and highly precise) were performed using the basic and advanced interfaces in both resources. Results: On average, 84% of studies were not listed in either resource. The largest number of included studies was retrieved in ClinicalTrials.gov and ICTRP when a sensitive search approach was used in the basic interface. The use of the advanced interface maintained or improved sensitivity in 16 of 19 strategies for Clinicaltrials.gov and 8 of 18 for ICTRP. No single search approach was sensitive enough to identify all studies included in the 6 reviews. Conclusions: Trials registers cannot yet be relied upon as the sole means to locate trials for systematic reviews. Trials registers lag behind the major bibliographic databases in terms of their search interfaces. Implications: For systematic reviews, trials registers and major bibliographic databases should be searched. Trials registers should be searched using sensitive approaches, and both the registers consulted in this study should be searched. PMID:25031558

  16. 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

  17. 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…

  18. Gateways to clinical trials.

    PubMed

    Bayes, M; Rabasseda, X; Prous, J R

    2005-11-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity(R), the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: (Z)-4-Hydroxytamoxifen, [18F]-FPS; Adalimumab, alefacept, alemtuzumab, alfimeprase, aprepitant, aripiprazole, atomoxetine hydrochloride; Belatacept, bortezomib; C340, caspofungin acetate, clazosentan sodium, Cypher; Darbepoetin alfa, DB-289, decitabine, dronedarone hydrochloride, duloxetine hydrochloride; Eletriptan, entecavir, ertapenem sodium, escitalopram oxalate, eszopiclone, etoricoxib; Gaboxadol, gadofosveset sodium, galiximab, gemifloxacin mesilate, glutamine; Human insulin; I-131 ch-TNT-1/B, indiplon, inhaled insulin, isatoribine; L-Arginine hydrochloride, liposomal doxorubicin, lopinavir/ritonavir, lumiracoxib; Magnesium sulfate; Natalizumab; Olmesartan medoxomil, omapatrilat, OncoVEX (GM-CSF); rDNA insulin, rupatadine fumarate; Sorafenib; Tadalafil, teduglutide, temsirolimus, tenofovir disoproxil fumarate, tiotropium bromide; Valdecoxib, vardenafil hydrochloride hydrate. PMID:16357953

  19. A Methodological Description of a Randomised Controlled Trial Comparing Hospital-Based Care and Hospital-Based Home Care when a Child is Newly Diagnosed with Type 1 Diabetes

    PubMed Central

    Tiberg, Irén; Carlsson, Annelie; Hallström, Inger

    2011-01-01

    Aim and objective: To describe the study design of a randomised controlled trial with the aim of comparing two different regimes for children with newly diagnosed type 1 diabetes; hospital-based care and hospital-based home care. Background: Procedures for hospital admission and sojourn in connection with diagnose vary greatly worldwide and the existing evidence is insufficient to allow for any conclusive determination of whether hospital-based or home-based care is the best alternative for most families. Comparative studies with adequate power and outcome measurements, as well as measurements of cost-effectiveness are needed. Design: The study design was based on the Medical Research Council framework for complex interventions. After two to three days with hospital-based care, children between the ages of 3 and 16 were randomised to receive either continued hospital-based care for a total of 1-2 weeks or hospital-based home care, which refers to specialist care in a home-based setting. The trial started in March 2008 at a University Hospital in Sweden and was closed in September 2011 when a sufficient number of children according to power calculation, were included. The primary outcome was the child’s metabolic control during the following two years. Secondary outcomes were set to evaluate the family and child situation as well as the organisation of care. Discussion: Childhood diabetes requires families and children to learn to perform multiple daily tasks. Even though intervention in health care is complex with several interacting components entailing practical and methodological difficulties, there is nonetheless, a need for randomised controlled trials in order to evaluate and develop better systems for the learning processes of families that can lead to long-term improvement in adherence and outcome. Trial Registration: Trial Register NCT00804232. PMID:22371819

  20. Mitigating the Effects of Nonadherence in Clinical Trials.

    PubMed

    Shiovitz, Thomas M; Bain, Earle E; McCann, David J; Skolnick, Phil; Laughren, Thomas; Hanina, Adam; Burch, Daniel

    2016-09-01

    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

  1. Design and baseline characteristics of the PODOSA (Prevention of Diabetes & Obesity in South Asians) trial: a cluster, randomised lifestyle intervention in Indian and Pakistani adults with impaired glycaemia at high risk of developing type 2 diabetes

    PubMed Central

    Douglas, Anne; Bhopal, Raj S; Bhopal, Ruby; Forbes, John F; Gill, Jason M R; McKnight, John; Murray, Gordon; Sattar, Naveed; Sharma, Anu; Wallia, Sunita; Wild, Sarah; Sheikh, Aziz

    2013-01-01

    Objectives To describe the design and baseline population characteristics of an adapted lifestyle intervention trial aimed at reducing weight and increasing physical activity in people of Indian and Pakistani origin at high risk of developing type 2 diabetes. Design Cluster, randomised controlled trial. Setting Community-based in Edinburgh and Glasgow, Scotland, UK. Participants 156 families, comprising 171 people with impaired glycaemia, and waist sizes ≥90 cm (men) and ≥80 cm (women), plus 124 family volunteers. Interventions Families were randomised into either an intensive intervention of 15 dietitian visits providing lifestyle advice, or a light (control) intervention of four visits, over a period of 3 years. Outcome measures The primary outcome is a change in mean weight between baseline and 3 years. Secondary outcomes are changes in waist, hip, body mass index, plasma blood glucose and physical activity. The cost of the intervention will be measured. Qualitative work will seek to understand factors that motivated participation and retention in the trial and families’ experience of adhering to the interventions. Results Between July 2007 and October 2009, 171 people with impaired glycaemia, along with 124 family volunteers, were randomised. In total, 95% (171/196) of eligible participants agreed to proceed to the 3-year trial. Only 13 of the 156 families contained more than one recruit with impaired glycaemia. We have recruited sufficient participants to undertake an adequately powered trial to detect a mean difference in weight of 2.5 kg between the intensive and light intervention groups at the 5% significance level. Over half the families include family volunteers. The main participants have a mean age of 52 years and 64% are women. Conclusions Prevention of Diabetes & Obesity in South Asians (PODOSA) is one of the first community-based, randomised lifestyle intervention trials in a UK South Asian population. The main trial results will

  2. Challenges and coping strategies of orphaned children in Tanzania who are not adequately cared for by adults.

    PubMed

    Daniel, Marguerite; Mathias, Angela

    2012-10-01

    Orphaned children in poor rural communities sometimes have no adult who is able to care for them or else the adult caregiver is not able to provide adequate care. Tanzania remains one of the poorest countries in the world, and poverty frequently constrains foster care. Although HIV prevalence is declining, AIDS is still a major cause of orphaning. This article explores the challenges and coping strategies accompanying two possible life trajectories for orphaned children without adequate adult care: 1) that they remain in rural areas in child-headed households, or 2) that they are trafficked to an urban area. Antonovsky's salutogenic model is used as the theoretical framework. The data come from two separate phenomenological studies with vulnerable children. In the first study, in-depth interviews were held with 12 orphaned children in a poor rural area; data concerning three child heads of households are included here. In the second study, 15 girls who were trafficked from rural areas to Dar es Salaam gave extended life-history narrations; data are included for nine of the girls who were orphaned. Loss of parents, a lack of cash, and the need to balance school attendance with food production were chronic stressors for the children heading households, while resources included income-generation strategies and the ability to negotiate with teachers for time to cultivate. For the trafficked girls chronic stressors included exploitation, long working hours, little or no pay, isolation and rape. Resources for them, although limited, included faith networks and neighbours; escape from the exploitative situation frequently involved external help. We conclude that given physical and social assets the child-headed households were able to cope with the challenges of caring for themselves and a younger child, but isolation and dependency on employers made it difficult for the trafficked girls to cope with this exploitation. The salutogenic model proved a useful tool in

  3. 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. PMID:16374695

  4. 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. PMID:17288503

  5. 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. PMID:26906103

  6. 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

  7. 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

    2016-03-01

    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

  8. TrialNet

    MedlinePlus

    ... Canada, Finland, United Kingdom, Italy, Germany, Australia, and New Zealand. This network is dedicated to the study, prevention, and early treatment of type 1 diabetes. Learn More > Visit us on Facebook Follow us on Twitter TrialNet YouTube Channel Department ...

  9. 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…

  10. 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. PMID:26166088

  11. 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. PMID:23689089

  12. Randomized controlled trials: what are they and who needs them?

    PubMed

    Pihlstrom, Bruce L; Curran, Alice E; Voelker, Helen T; Kingman, Albert

    2012-06-01

    Dentistry is rapidly entering a new era of evidence-based practice, and society is demanding prevention and treatment that has been proven to be effective in terms of meaningful health outcomes. Practitioners, individual patients and the public need randomized controlled trials because they provide the highest level of scientific evidence to change clinical practice and inform public health policy. Well-designed randomized controlled trials are conceptually simple but deceptively complex to design, implement and translate into clinical practice. Randomized controlled trials are fundamentally different from observational clinical research because they randomly assign volunteers to receive test or control interventions, they are prospective and the success of the test intervention is based on a meaningful clinical outcome that is specified before the trial begins. To be successful, randomized controlled trials must be carefully designed and powered to answer a specific question that will be generalizable to the population under study. Randomized controlled trials can be designed to evaluate efficacy, effectiveness, superiority, equivalence or noninferiority. Prominent issues and challenges in designing and conducting randomized controlled trials include carefully defining enrollment criteria, establishing an organizational infrastructure, use of a data-coordinating center, developing a manual of procedures, obtaining informed consent, recruiting and ensuring the safety of volunteer subjects, ensuring data quality, analysis and publication of trial outcomes, and translating results into clinical practice. PMID:22507057

  13. 14 CFR 29.1331 - Instruments using a power supply.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ....1331 Instruments using a power supply. For category A rotorcraft— (a) Each required flight instrument... power source; and (3) A visual means integral with each instrument to indicate when the power adequate to sustain proper instrument performance is not being supplied. The power must be measured at or...

  14. 14 CFR 29.1331 - Instruments using a power supply.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ....1331 Instruments using a power supply. For category A rotorcraft— (a) Each required flight instrument... power source; and (3) A visual means integral with each instrument to indicate when the power adequate to sustain proper instrument performance is not being supplied. The power must be measured at or...

  15. Is fresh frozen plasma clinically effective? A systematic review of randomized controlled trials.

    PubMed

    Stanworth, S J; Brunskill, S J; Hyde, C J; McClelland, D B L; Murphy, M F

    2004-07-01

    Summary Randomized controlled trials of good quality are a recognized means to robustly assess the efficacy of interventions in clinical practice. A systematic identification and appraisal of all randomized trials involving fresh frozen plasma (FFP) has been undertaken in parallel to the drafting of the updated British Committee for Standards in Haematology guidelines on the use of FFP. A total of 57 trials met the criteria for inclusion in the review. Most clinical uses of FFP, currently recommended by practice guidelines, are not supported by evidence from randomized trials. In particular, there is little evidence for the effectiveness of the prophylactic use of FFP. Many published trials on the use of FFP have enrolled small numbers of patients, and provided inadequate information on the ability of the trial to detect meaningful differences in outcomes between the two patient groups. Other concerns about the design of the trials include the dose of FFP used, and the potential for bias. No studies have taken adequate account of the extent to which adverse effects might negate the clinical benefits of treatment with FFP. There is a need to consider how best to develop new trials to determine the efficacy of FFP in different clinical scenarios to provide the evidence base to support national guidelines for transfusion practice. Trials of modified FFP (e.g. pathogen inactivated) are of questionable value when there is little evidence that the standard product is an effective treatment. PMID:15198745

  16. Justification for conducting neurological clinical trials as part of patient care within private practice.

    PubMed

    Beran, R G; Stepanova, D; Beran, M E

    2016-05-01

    The aim of this review was to assess the benefits and drawbacks of conducting neurological clinical trials and research in private practice for the patients, clinician, Practice Manager, sponsors/Clinical Research Organisations (CROs) and Clinical Trial Coordinator (CTC) to determine if this is justified for all involved. A combination of literature reviews, original research articles and books were selected from 2005 to 2015. Provided that the practice has sufficient number of active trials to prevent financial loss, support staff, adequate facilities and equipment and time, the benefits outweigh the drawbacks. Clinical trials provide patients with more thorough monitoring, re-imbursement of trial-related expenses and the opportunity to try an innovative treatment at no charge when other options have failed. For the clinician, clinical trials provide more information to ensure better care for their patients and improved treatment methods, technical experience and global recognition. Trials collect detailed and up-to-date information on the benefits and risks of drugs, improving society's confidence in clinical research and pharmaceuticals, allow trial sponsors to explore new scientific questions and accelerate innovation. For the CTC, industry-sponsored clinical trials allow potential entry for a career in clinical research giving CTCs the opportunity to become Clinical Research Associates (CRAs), Study Start-Up Managers or Drug Safety Associates. PMID:27040457

  17. Organizing person-centred care in paediatric diabetes: multidisciplinary teams, long-term relationships and adequate documentation

    PubMed Central

    2014-01-01

    Background Type 1 diabetes is one of the most frequent long-term endocrine childhood disorders and the Swedish National Diabetes Register for children states that adolescents (12–18 years) constitute the most vulnerable patient group in terms of metabolic control. The aim of this study was to examine how a multidisciplinary team functions when caring for adolescents with type 1 diabetes. Methods Qualitative interviews were performed with 17 health professionals at a Paediatric Diabetes Care Unit in a Swedish university hospital. The interviews were analysed to gain insight into a multidisciplinary care team’s experiences of various organizational processes and circumstances related to the provision of person-centred paediatric diabetes care. Results Building long-term relationships with adolescents, the establishment of a multidisciplinary care team and ensuring adequate documentation are vital for the delivery of person-centred care (PCC). Furthermore, a PCC process and/or practice requires more than the mere expression of person-centred values. The contribution of this study is that it highlights the necessity of facilitating and safeguarding the organization of PCC, for which three processes are central: 1. Facilitating long-term relationships with adolescents and their families; 2. Facilitating multi-professional teamwork; and 3. Ensuring adequate documentation. Conclusion Three processes emerged as important for the functioning of the multidisciplinary team when caring for adolescents with type 1 diabetes: building a long-term relationship, integrating knowledge by means of multidisciplinary team work and ensuring adequate documentation. This study demonstrates the importance of clearly defining and making use of the specific role of each team member in the paediatric diabetes care unit (PDCU). Team members should receive training in PCC and a PCC approach should form the foundation of all diabetes care. Every adolescent suffering from type 1 diabetes

  18. 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.

  19. Power options for lunar exploration

    NASA Astrophysics Data System (ADS)

    Bamberger, Judith Ann; Gaustad, Krista 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 compares their ranges of applicability. The importance of a systems approach to the integration of these components will also be discussed.

  20. Miniature Radioisotope Thermoelectric Power Cubes

    NASA Technical Reports Server (NTRS)

    Patel, Jagdish U.; Fleurial, Jean-Pierre; Snyder, G. Jeffrey; Caillat, Thierry

    2004-01-01

    Cube-shaped thermoelectric devices energized by a particles from radioactive decay of Cm-244 have been proposed as long-lived sources of power. These power cubes are intended especially for incorporation into electronic circuits that must operate in dark, extremely cold locations (e.g., polar locations or deep underwater on Earth, or in deep interplanetary space). Unlike conventional radioisotope thermoelectric generators used heretofore as central power sources in some spacecraft, the proposed power cubes would be small enough (volumes would range between 0.1 and 0.2 cm3) to play the roles of batteries that are parts of, and dedicated to, individual electronic-circuit packages. Unlike electrochemical batteries, these power cubes would perform well at low temperatures. They would also last much longer: given that the half-life of Cm-244 is 18 years, a power cube could remain adequate as a power source for years, depending on the power demand in its particular application.

  1. Prevalence and correlates of adequate performance on a measure of abilities related to decisional capacity: differences among three standards for the MacCAT-CR in patients with schizophrenia.

    PubMed

    Dunn, Laura B; Palmer, Barton W; Appelbaum, Paul S; Saks, Elyn R; Aarons, Gregory A; Jeste, Dilip V

    2007-01-01

    Despite the availability of structured decision-making capacity assessment tools, insufficient guidance exists for applying their results. Investigators often use cutpoints on these instruments to identify potential subjects in need of further assessment or education. Yet, information is lacking regarding the effects of different cutpoints on the proportion and characteristics of individuals categorized as possessing adequate or impaired decisional abilities for consent to research. To demonstrate the potential impact of different standards, we informed 91 individuals, aged 50 or older with a diagnosis of schizophrenia or schizoaffective disorder, about a hypothetical clinical trial, and assessed their decisional abilities with the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). Three published MacCAT-CR-based standards were applied to participants' scores to examine the rates and correlates of categorical determinations of adequate performance. The three standards ranged in stringency: the most stringent incorporated cutpoints on all three of the major MacCAT-CR subscales (Understanding, Appreciation, and Reasoning); the other two standards required threshold performance only on the Understanding subscale. The most stringent standard resulted in a 57% rate of impaired performance; the intermediate standard, 19%; and the least stringent standard, 8%. Nearly half of the participants (n=45) were classified as having performed adequately by the least stringent standard yet inadequately by the most stringent. The majority of these 45 were impaired on the Appreciation subscale (n=9), Reasoning (n=15), or both (n=18). Cognitive functioning was correlated with performance status for the more stringent standards. These findings underscore the need for refinement of capacity assessment procedures and for improvements in the use of capacity assessment tools for screening purposes and to assist in categorical capacity determinations. PMID:17020803

  2. 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…

  3. Statistical design considerations applicable to clinical trials of iodine supplementation in pregnant women who may be mildly iodine deficient.

    PubMed

    Troendle, James F

    2016-09-01

    No large, randomized, placebo-controlled trial of iodine supplementation in pregnant women in a region of mild or moderate iodine deficiency has been completed in which a primary outcome measure was an assessment of the neurobehavioral development of the offspring at age ≥2 y. In this article, I discuss considerations for the design of such a trial in a region of mild iodine deficiency, with a focus on statistical methods and approaches. Exposure and design issues include the ethics of using a placebo, the potential for overexposure to iodine, and the possibility of community randomization. The main scientific goal of the trial is important in determining the follow-up period. If the goal is to determine whether iodine supplementation during pregnancy improves neurobehavioral development in the offspring, then follow-up should continue until a reasonably reliable assessment can be conducted, which might be at age ≥2 y. Once the timing of assessment is decided, the impact of potential loss to follow-up should be considered so that appropriate statistical methods can be incorporated into the design. The minimum sample size can be calculated by using a sample size formula that incorporates noncompliance and assumes that a certain proportion of study participants do not have any outcome observed. To have sufficient power to detect a reasonably modest difference in neurobehavioral development scores using an assessment tool with an SD of 15, a large number of participants (>500/group) is required. The minimum adequate number of participants may be even larger (>1300/group) depending on the magnitude of the difference in outcome between the supplementation and placebo groups, the estimated proportion of the iodine-supplementation group that fails to take the supplement, and the estimated proportion of pregnancies that do not produce outcome measurements. PMID:27534639

  4. The Effect of Inhaled IFN-β on Worsening of Asthma Symptoms Caused by Viral Infections. A Randomized Trial

    PubMed Central

    Harrison, Tim; Johnston, Sebastian L.; Gabbay, Flic; Wark, Peter; Thomson, Neil C.; Niven, Robert; Singh, Dave; Reddel, Helen K.; Davies, Donna E.; Marsden, Richard; Boxall, Christine; Dudley, Sarah; Plagnol, Vincent; Holgate, Stephen T.; Monk, Phillip

    2014-01-01

    Rationale: Ex vivo, bronchial epithelial cells from people with asthma are more susceptible to rhinovirus infection caused by deficient induction of the antiviral protein, IFN-β. Exogenous IFN-β restores antiviral activity. Objectives: To compare the efficacy and safety of inhaled IFN-β with placebo administered to people with asthma after onset of cold symptoms to prevent or attenuate asthma symptoms caused by respiratory viruses. Methods: A total of 147 people with asthma on inhaled corticosteroids (British Thoracic Society Steps 2–5), with a history of virus-associated exacerbations, were randomized to 14-day treatment with inhaled IFN-β (n = 72) or placebo (n = 75) within 24 hours of developing cold symptoms and were assessed clinically, with relevant samples collected to assess virus infection and antiviral responses. Measurements and Main Results: A total of 91% of randomized patients developed a defined cold. In this modified intention-to-treat population, asthma symptoms did not get clinically significantly worse (mean change in six-item Asthma Control Questionnaire <0.5) and IFN-β treatment had no significant effect on this primary endpoint, although it enhanced morning peak expiratory flow recovery (P = 0.033), reduced the need for additional treatment, and boosted innate immunity as assessed by blood and sputum biomarkers. In an exploratory analysis of the subset of more difficult-to-treat, Step 4-5 people with asthma (n = 27 IFN-β; n = 31 placebo), Asthma Control Questionnaire-6 increased significantly on placebo; this was prevented by IFN-β (P = 0.004). Conclusions: Although the trial did not meet its primary endpoint, it suggests that inhaled IFN-β is a potential treatment for virus-induced deteriorations of asthma in difficult-to-treat people with asthma and supports the need for further, adequately powered, trials in this population. Clinical trial registered with www.clinicaltrials.gov (NCT 01126177). PMID:24937476

  5. Supplemental Escherichia coli phytase and strontium enhance bone strength of young pigs fed a phosphorus-adequate diet.

    PubMed

    Pagano, Angela R; Yasuda, Koji; Roneker, Karl R; Crenshaw, Thomas D; Lei, Xin Gen

    2007-07-01

    Young pigs represent an excellent model of youth to assess potentials of dietary factors for improving bone structure and function. We conducted 2 experiments to determine whether adding microbial phytase (2,000 U/kg, OptiPhos, JBS United) and Sr (50 mg/kg, SrCO3 Alfa Aesar) into a P-adequate diet further improved bone strength of young pigs. In Expt. 1, 24 gilts (8.6 +/- 0.1 kg body wt) were divided into 2 groups (n = 12), and fed a corn-soybean-meal basal diet (BD, 0.33% available P) or BD + phytase for 6 wk. In Expt. 2, 32 pigs (11.4 +/- 0.2 kg) were divided into 4 groups (n = 8), and fed BD, BD + phytase, BD + Sr, or BD + phytase and Sr for 5 wk. Both supplemental phytase and Sr enhanced (P < 0.05) breaking strengths (11-20%), mineral content (6-15%), and mineral density (6-11%) of metatarsals and femurs. Supplemental phytase also resulted in larger total bone areas (P < 0.05) and a larger cross-sectional area of femur (P = 0.06). Concentrations of Sr were elevated 4-fold (P < 0.001) in both bones by Sr, and moderately increased (P = 0.05-0.07) in metatarsal by phytase. In conclusion, supplemental phytase at 2000 U/kg of P-adequate diets enhanced bone mechanical function of weanling pigs by modulating both geometrical and chemical properties of bone. The similar benefit of supplemental Sr was mainly due to an effect on bone chemical properties. PMID:17585033

  6. Technical basis for flawed cylinder test specification to assure adequate fracture resistance of ISO high-strength steel cylinder

    SciTech Connect

    Rana, M.D.; Smith, J.H.; Tribolet, R.O.

    1997-11-01

    High-pressure industrial gases (such as oxygen, nitrogen, argon, hydrogen, etc.) are stored and transported in portable cylinders. ISO TC58 SC3 has developed a draft specification 9809 for design and fabrication of high-pressure cylinders with maximum tensile strength limitation of 1,100 N/mm{sup 2}. In order to extend the ISO 9809 rules for higher than 1,100 N/mm{sup 2} strength level cylinders, a working group WG14 was formed in 1989 to develop new rules to assure adequate fracture resistance. In 1994, WG14 recommended a simple, but unique flawed cylinder test method for design qualification of the cylinder and acceptance criteria to assure adequate fracture resistance. WG14 also recommended Charpy-V-notch impact tests to control the required fracture resistance on production cylinders. This paper presents the technical basis that was employed in developing the flawed cylinder test method and acceptance criteria. The specification was developed for seamless steel cylinders having actual strength in the range of 1,100 to 1,400 N/mm{sup 2} and cylindrical section wall thickness in the range of 3 to 10 mm. Flawed cylinder tests were conducted on several hundred cylinders of varying sizes and strength levels. The specification requires to demonstrate LEAK-BEFORE-BREAK performance of the cylinder having flaw length equal to 1.6 (o.d. {times} t{sub design}){sup 0.5} at failure pressure = (t{sub design}/t{sub actual}) x Design Pressure.

  7. Safety and Efficacy of Rivastigmine in Patients With Alzheimer's Disease Not Responding Adequately to Donepezil: An Open-Label Study

    PubMed Central

    Figiel, Gary S.; Sadowsky, Carl H.; Strigas, John; Koumaras, Barbara; Meng, Xiangyi; Gunay, Ibrahim

    2008-01-01

    Objective: Switching patients with Alzheimer's disease from one cholinesterase inhibitor to another represents a viable option for patients not responding to current therapy. The objective of this large U.S.-based study was to evaluate the safety and efficacy of a treatment switch to rivastigmine in patients not responding adequately to or declining on treatment with donepezil. Method: In this 26-week, prospective, open-label, single-arm, multicenter study conducted from April 24, 2003, to June 25, 2004, patients with mild-to-moderate Alzheimer's disease (DSM-IV-TR criteria) who were not responding to donepezil were treated with rivastigmine 3–12 mg/day. Safety and tolerability were measured by the occurrence of adverse events and patient disposition. Treatment effects on global functioning were assessed using the Clinical Global Impression of Change (CGIC) scale. Results: Two hundred seventy patients with a mean age of 78.5 (SD = 7.56) years and a mean duration of dementia of 3.5 (SD = 2.06) years were included in the study. Sixty-nine percent of patients completed the study with 17.8% discontinuing due to adverse events. Eighty-three percent of patients reported at least 1 adverse event, with the most frequently occurring adverse events affecting the gastrointestinal system (54%). The majority of patients were reported to have either improvement or no decline on the CGIC. A limitation of the study is that the interpretation of the results is based on an overall completion rate of 69%. Conclusion: Immediately switching patients from donepezil to rivastigmine without a washout period was safe and well tolerated in the current study. Additionally, these results suggest that patients not responding adequately to or declining while taking donepezil may improve or stabilize after switching to rivastigmine. PMID:18787673

  8. Telotristat etiprate, a novel serotonin synthesis inhibitor, in patients with carcinoid syndrome and diarrhea not adequately controlled by octreotide.

    PubMed

    Kulke, Matthew H; O'Dorisio, Thomas; Phan, Alexandria; Bergsland, Emily; Law, Linda; Banks, Phillip; Freiman, Joel; Frazier, Kenny; Jackson, Jessica; Yao, James C; Kvols, Larry; Lapuerta, Pablo; Zambrowicz, Brian; Fleming, Douglas; Sands, Arthur

    2014-10-01

    Serotonin produced by neuroendocrine tumors is believed to be a principal cause of the diarrhea in carcinoid syndrome. We assessed the safety and efficacy of telotristat etiprate, an oral serotonin synthesis inhibitor, in patients with diarrhea associated with carcinoid syndrome. In this prospective, randomized study, patients with evidence of carcinoid tumor and ≥4 bowel movements (BMs)/day despite stable-dose octreotide LAR depot therapy were enrolled in sequential, escalating, cohorts of four patients per cohort. In each cohort, one patient was randomly assigned to placebo and three patients to telotristat etiprate, at 150, 250, 350, or 500 mg three times a day (tid). In a subsequent cohort, one patient was assigned to placebo and six patients to telotristat etiprate 500 mg tid. Patients were assessed for safety, BM frequency (daily diary), 24 h urinary 5-hydroxyindoleacetic acid (u5-HIAA), and adequate relief of carcinoid gastrointestinal symptoms (using a weekly questionnaire). Twenty-three patients were treated: 18 received telotristat etiprate and five received placebo. Adverse events were generally mild. Among evaluable telotristat etiprate-treated patients, 5/18 (28%) experienced a ≥30% reduction in BM frequency for ≥2 weeks, 9/16 (56%) experienced biochemical response (≥50% reduction or normalization in 24-h u5-HIAA) at week 2 or 4, and 10/18 (56%) reported adequate relief during at least 1 of the first 4 weeks of treatment. Similar activity was not observed in placebo-treated patients. Telotristat etiprate was well tolerated. Our observations suggest that telotristat etiprate has activity in controlling diarrhea associated with carcinoid syndrome. Further studies confirming these findings are warranted. PMID:25012985

  9. 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. PMID:16614427

  10. Telotristat Etiprate, a Novel Serotonin Synthesis Inhibitor, in Patients with Carcinoid Syndrome and Diarrhea Not Adequately Controlled by Octreotide

    PubMed Central

    Kulke, Matthew H.; O’Dorisio, Thomas; Phan, Alexandria; Bergsland, Emily; Law, Linda; Banks, Phillip; Freiman, Joel; Frazier, Kenny; Jackson, Jessica; Yao, James C.; Kvols, Larry; Lapuerta, Pablo; Zambrowicz, Brian; Fleming, Douglas; Sands, Arthur

    2014-01-01

    Serotonin produced by neuroendocrine tumors is believed to be a principal cause of the diarrhea in carcinoid syndrome. We assessed the safety and efficacy of telotristat etiprate, an oral serotonin synthesis inhibitor, in patients with diarrhea associated with carcinoid syndrome. In this prospective, randomized study, patients with evidence of carcinoid tumor and ≥4 bowel movements (BMs)/day despite stable-dose octreotide LAR depot therapy were enrolled in sequential, escalating, cohorts of 4 patients/cohort. In each cohort, 1 patient was randomly assigned to placebo and 3 patients to telotristat etiprate, at 150, 250, 350, or 500 mg 3x/day (tid). In a subsequent cohort, 1 patient was assigned to placebo and 6 patients to telotristat etiprate 500 mg tid. Patients were assessed for safety, BM frequency (daily diary), 24-hour urinary 5-hydroxyindoleacetic acid (u5-HIAA), and adequate relief of carcinoid gastrointestinal symptoms (using a weekly questionnaire). Twenty-three patients were treated; 18 received telotristat etiprate and 5 received placebo. Adverse events were generally mild. Among evaluable telotristat etiprate-treated patients, 5/18 (28%) experienced a ≥30% reduction in BM frequency for ≥2 weeks, 9/16 (56%) experienced biochemical response (≥50% reduction or normalization in 24-hour u5-HIAA) at Week 2 or 4, and 10/18 (56%) reported adequate relief during at least 1 of the first 4 weeks of treatment. Similar activity was not observed in placebo-treated patients. Telotristat etiprate was well tolerated. Our observations suggest that telotristat etiprate has activity in controlling diarrhea associated with carcinoid syndrome. Further studies confirming these findings are warranted. PMID:25012985

  11. Recruitment methods employed in the prostate, lung, colorectal, and ovarian cancer screening trial

    PubMed Central

    Gren, Lisa; Broski, Karen; Childs, Jeffery; Cordes, Jill; Engelhard, Deborah; Gahagan, Betsy; Gamito, Eduard; Gardner, Vivien; Geisser, Mindy; Higgins, Darlene; Jenkins, Victoria; Lamerato, Lois; Lappe, Karen; Lowery, Heidi; McGuire, Colleen; Miedzinski, Mollie; Ogden, Sheryl; Tenorio, Sally; Watt, Gavin; Wohlers, Bonita; Marcus, Pamela

    2015-01-01

    Background The Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) is a US National Cancer Institute (NCI)-funded randomized controlled trial designed to evaluate whether certain screening tests reduce mortality from prostate, lung, colorectal, and ovarian cancer. To obtain adequate statistical power, it was necessary to enroll over 150,000 healthy volunteers. Recruitment began in 1993 and ended in 2001. Purpose Our goal is to evaluate the success of recruitment methods employed by the 10 PLCO screening centers. We also provide estimates of recruitment yield and cost for our most successful strategy, direct mail. Methods Each screening center selected its own methods of recruitment. Methods changed throughout the recruitment period as needed. For this manuscript, representatives from each screening center provided information on methods utilized and their success. Results In the United States between 1993 and 2001, ten screening centers enrolled 154,934 study participants. Based on participant self-report, an estimated 95% of individuals were recruited by direct mail. Overall, enrollment yield for direct mail was 1.0%. Individual center enrollment yield ranged from 0.7% to 3.8%. Cost per enrolled participant was $9.64–35.38 for direct mail, excluding personnel costs. Limitations Numeric data on recruitment processes were not kept consistently at individual screening centers. Numeric data in this manuscript are based on the experiences of 5 of the 10 centers. Conclusions Direct mail, using rosters of names and addresses from profit and not-for-profit (including government) organizations, was the most successful and most often used recruitment method. Other recruitment strategies, such as community outreach and use of mass media, can be an important adjunct to direct mail in recruiting minority populations. PMID:19254935

  12. 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

  13. Can exercise improve self esteem in children and young people? A systematic review of randomised controlled trials.

    PubMed

    Ekeland, E; Heian, F; Hagen, K B

    2005-11-01

    A systematic review to determine if exercise alone or as part of a comprehensive intervention can improve self esteem in children and young people is described. 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

  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. 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

  16. Is Outpatient Cognitive Remediation Therapy Feasible to Use in Randomized Clinical Trials for Anorexia Nervosa?

    PubMed Central

    Lock, James; Agras, W. Stewart; Fitzpatrick, Kathleen Kara; Bryson, Susan W.; Jo, Booil; Tchanturia, Kate

    2013-01-01

    Objective There are limited data supporting specific treatments for adults with anorexia nervosa (AN). Randomized Clinical Trials (RCTs) for adults with AN are characterized by high attrition limiting the feasibility of conducting and interpreting existing studies. High dropout rates may be relatedt to the inflexible and obsessional cognitive style of AN patients. This study evaluated the feasibility of using Cognitive Remediation Therapy (CRT) to reduce attrition in RCTs for AN. Method Forty-six participants (mean age of 22.7 years and mean duration of AN of 6.4 years) were randomized to receive 8 sessions of either CRT or CBT over 2 months followed by 16 sessions of CBT for 4 months. Results During the two month CRT vs. CBT treatment, rates of attrition were lower in CRT (13%) compared to CBT (33%). There were greater improvements in cognitive inefficiencies in the CRT compared to the CBT group at the end of two months. There were no differences in other outcomes. Conclusion These results suggest that CRT is acceptable and feasible for use in RCTs for outpatient treatment of AN. CRT may reduce attrition in the short term. Adequately powered future studies are needed to examine CRT as an outpatient treatment for AN. PMID:23625628

  17. 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.

  18. Cluster Randomized Controlled Trial

    PubMed Central

    Young, John; Chapman, Katie; Nixon, Jane; Patel, Anita; Holloway, Ivana; Mellish, Kirste; Anwar, Shamaila; Breen, Rachel; Knapp, Martin; Murray, Jenni; Farrin, Amanda

    2015-01-01

    Background and Purpose— We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke. Methods— A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months. Results— Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was −0.6 points (95% confidence interval, −1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups. Conclusions— This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice. Clinical Trial Registration— URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305. PMID:26152298

  19. 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

  20. NATO SOCMET trials

    NASA Astrophysics Data System (ADS)

    Jenden, C. M.

    1993-11-01

    During 1993, Canada, France, Germany and the United Kingdom will be participating in the Smoke and Obscurants Countermeasures Materials Evaluation Tests (SOCMET). The tests will be carried out under the auspices of the NATO Army Armaments Group, AC/225, Panel VI, Sub-Panel 7 whose interests include multispectral smoke screening systems. The tests will comprise two sets of trials; one under cold climate conditions in Quebec, Canada, during February/March 1993 and the other in temperate conditions in Bourges, France during September 1993. This paper provides an insight into the management and aims of SOCMET. The evaluations will be seeking to identify candidate materials which create effective obscurant screens in the visible, infrared and millimetric bands of the electromagnetic spectrum. These materials will be disseminated through a range area dispersal. A key element of the trials will be the evaluation of field test instrumentation which may eventually lead to the development of standardized evaluation techniques. Following the trials, a scientific workshop will be held to review the results. A final report will be presented to NATO which will form the basis of future collaborative developments on multispectral screening systems leading towards standard NATO documentation on smoke and obscurant systems.

  1. Gateways to clinical trials.

    PubMed

    Bayés, M; Rabasseda, X; Prous, J R

    2005-09-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in the current literature and congresses. The data in 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 issue focuses on the following selection of drugs: AAV-NGFbeta, aprepitant, aripiprazole, atomoxetine hydrochloride; beta-Methyl-6-chloromelatonin, BMS-214662, bortezomib, bosentan; Calcipotriol/betamethasone dipropionate, CEA-TRICOM, cetuximab, ciclesonide, clofarabine, Cypher; Dalbavancin, darbepoetin alfa, darifenacin hydrobromide, desloratadine, Dexamet, drospirenone, drospirenone/ethinylestradiol, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Ecogramostim, efalizumab, ertapenem sodium, escitalopram oxalate, eszopiclone; Fenretinide; Gefitinib, gestodene, ghrelin (human); hMaxi-K, human papillomavirus vaccine; Imatinib mesylate, indiplon, iodine (i131) tositumomab, irofulven, ISS-1018; Lasofoxifene tartrate, levodopa/carbidopa/entacapone, liposomal doxorubicin; Nemifitide ditriflutate, nesiritide; Omalizumab; Pegfilgrastim, peginterferon alfa-2a, peginterferon alfa-2b, phVEGF-A165, pimecrolimus, pramlintide acetate; Rasburicase, rimonabant hydrochloride; Satraplatin, St. John's Wort extract, sunitinib malate; Tadalafil, tanaproget, Taxus, tiotropium bromide, treprostinil sodium; Valdecoxib, vardenafil hydrochloride hydrate; Ximelagatran; Zileuton. PMID:16258596

  2. Gateways to clinical trials.

    PubMed

    Bayés, M; Rabasseda, X; Prous, J R

    2005-03-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in 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 issue focuses on the following selection of drugs: 3-AP, 667-coumate, 9-aminocamptothecin; Ad5CMV-p53, AES-14, alefacept, anecortave acetate, APC-8024, APD-356, asoprisnil; Bevacizumab, bimakalim, bimatoprost, BLP-25, BR-1; Caspofungin acetate, cetuximab, cypher; Darbepoetin alfa, dexanabinol, dextromethorphan/quinidine sulfate, DNA.HIVA; Efaproxiral sodium, ertapenem sodium; Frovatriptan; HuMax-EGFr, HYB-2055, gamma-hydroxybutyrate sodium, Id-KLH vaccine, imatinib mesylate; Lapatinib, lonafarnib, Motexafin lutetium, MVA.HIVA, mycophenolic acid sodium salt; Nesiritide, NS-2330; Olmesartan medoxomil; Peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, pemetrexed disodium, perifosine, pimecrolimus, pregabalin; QbG-10; Ralfinamide, rasburicase, rFGF-2, Ro-31-7453; Sitaxsentan sodium, sorafenib; Tadalafil, TC-1734, telmisartan/hydrochlorothiazide, tenofovir disoproxil fumarate, thymus nuclear protein, tipifarnib; Vandetanib, vibriolysin, vildagliptin, voriconazole. PMID:15834466

  3. Gateways to clinical trials.

    PubMed

    Bayes, M; Rabasseda, X; Prous, J R

    2006-06-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in 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 issue focuses on the following selection of drugs: 131-I-chlorotoxin; Ad5CMV-p53, adalimumab, albumin interferon alfa, alemtuzumab, aliskiren fumarate, aminolevulinic acid methyl ester, anakinra, AR-C126532, atomoxetine hydrochloride; Bevacizumab, bosentan, botulinum toxin type B, brimonidine tartrate/timolol maleate; Calcipotriol/betamethasone dipropionate, cangrelor tetrasodium, cetuximab, ciclesonide, cinacalcet hydrochloride, collagen-PVP, Cypher; Darbepoetin alfa, darusentan, dasatinib, denosumab, desloratadine, dexosome vaccine (lung cancer), dexrazoxane, dextromethorphan/quinidine sulfate, duloxetine hydrochloride; ED-71, eel calcitonin, efalizumab, entecavir, etoricoxib; Falciparum merozoite protein-1/AS02A, fenretinide, fondaparinux sodium; gamma-Hydroxybutyrate sodium, gefitinib, ghrelin (human); hLM609; Icatibant acetate, imatinib mesylate, ipsapirone, irofulven; LBH-589, LE-AON, levocetirizine, LY-450139; Malaria vaccine, mapatumumab, motexafin gadolinium, muraglitazar, mycophenolic acid sodium salt; nab-paclitaxel, nelarabine; O6-Benzylguanine, olmesartan medoxomil, orbofiban acetate; Panitumumab, peginterferon alfa-2a, peginterferon alfa-2b, pemetrexed disodium, peptide YY3-36, pleconaril, prasterone, pregabalin; Ranolazine, rebimastat, recombinant malaria vaccine, rosuvastatin calcium; SQN-400; Taxus, tegaserod maleate, tenofovir disoproxil fumarate, teriparatide, troxacitabine; Valganciclovir hydrochloride, Val-Tyr sardine peptidase, VNP-40101M, vorinostat. PMID:16845450

  4. Gateways to clinical trials.

    PubMed

    Bayés, M; Rabasseda, X; Prous, J R

    2005-12-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in 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 issue focuses on the following selection of drugs: 131I-chTNT; Abatacept, adalimumab, alemtuzumab, APC-8015, aprepitant, atazanavir sulfate, atomoxetine hydrochloride, azimilide hydrochloride; Bevacizumab, bortezomib, bosentan, buserelin; Caspofungin acetate, CC-4047, ChAGCD3, ciclesonide, clopidogrel, curcumin, Cypher; Dabigatran etexilate, dapoxetine hydrochloride, darbepoetin alfa, darusentan, denosumab, DMXB-Anabaseine, drospirenone, drospirenone/estradiol, duloxetine hydrochloride, dutasteride; Edodekin alfa, efaproxiral sodium, elaidic acid-cytarabine, erlotinib hydrochloride, ertapenem sodium, escitalopram oxalate, eszopiclone, etonogestrel/testosterone decanoate, exenatide; Fulvestrant; Gefitinib, glycine, GVS-111; Homoharringtonine; ICC-1132, imatinib mesylate, iodine (I131) tositumomab, i.v. gamma-globulin; Levetiracetam, levocetirizine, lintuzumab, liposomal nystatin, lumiracoxib, lurtotecan; Manitimus, mapatumumab, melatonin, micafungin sodium, mycophenolic acid sodium salt; Oblimersen sodium, OGX-011, olmesartan medoxomil, omalizumab, omapatrilat, oral insulin; Parathyroid hormone (human recombinant), pasireotide, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, phVEGF-A165, pimecrolimus, pitavastatin calcium, plerixafor hydrochloride, posaconazole, pramlintide acetate, prasterone, pregabalin, PT-141; Quercetin; Ranolazine, rosuvastatin calcium, rubitecan, rupatadine fumarate; Sardomozide, sunitinib malate; Tadalafil, talactoferrin alfa, tegaserod maleate, telithromycin, testosterone transdermal patch, TH-9507, tigecycline, tiotropium bromide, tipifarnib, tocilizumab, treprostinil sodium; Valdecoxib, vandetanib

  5. Black participation in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.

    PubMed

    Stallings, F L; Ford, M E; Simpson, N K; Fouad, M; Jernigan, J C; Trauth, J M; Miller, D S

    2000-12-01

    The primary goal of the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial is to learn whether widespread use of screening tests to detect these cancers will reduce associated mortality. Blacks have the highest age-adjusted cancer incidence and mortality rates of any population group in the United States, but several barriers to their participation in clinical research such as the PLCO trial exist. These barriers involve sociocultural, economic, and individual factors, as well as factors inherent in trial designs. Population diversity in the PLCO trial is necessary to preserve scientific validity and generalizability of trial results. Therefore, the National Cancer Institute and the Centers for Disease Control and Prevention are collaborating to ensure adequate representation of blacks in the PLCO trial. For example, the agencies have funded several new activities designed to better understand and overcome barriers to participation in the trial. These activities include the African American Men Project, a randomized trial designed to evaluate the efficacy of three increasingly intensive recruitment interventions in recruiting black men; the establishment of a minority-focused PLCO trial screening center, a study to identify factors that influenced the decisions of black women recruited to participate in the PLCO trial; and a study to examine the psychosocial factors that influence blacks' decision making to engage in cancer screening and participation in research similar to the PLCO trial. The results of these activities will allow for a more thorough examination of cancer-related issues of importance to blacks and will help shed light on factors that influence their decisions to participate in cancer screening and prevention clinical trials. PMID:11189689

  6. Comorbidity Structure of Psychological Disorders in the Online e-PASS Data as Predictors of Psychosocial Adjustment Measures: Psychological Distress, Adequate Social Support, Self-Confidence, Quality of Life, and Suicidal Ideation

    PubMed Central

    Klein, Britt; Meyer, Denny

    2014-01-01

    positively related to psychological distress and suicidal ideation, but negatively related to adequate social support, self-confidence, and quality of life. Conclusions This exploratory study identified 4 comorbidity factors in the e-PASS data and these factor scores significantly predicted 5 psychosocial adjustment measures. Trial Registration Australian and New Zealand Clinical Trials Registry ACTRN121611000704998; http://www.anzctr.org.au/trial_view.aspx?ID=336143 (Archived by WebCite at http://www.webcitation.org/618r3wvOG). PMID:25351885

  7. 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

  8. 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

  9. 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

  10. 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

  11. Healthcare Costs Associated with an Adequate Intake of Sugars, Salt and Saturated Fat in Germany: A Health Econometrical Analysis

    PubMed Central

    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. PMID:26352606

  12. Adequate dietary vitamin D and calcium are both required to reduce bone turnover and increased bone mineral volume.

    PubMed

    Lee, Alice M C; Sawyer, Rebecca K; Moore, Alison J; Morris, Howard A; O'Loughlin, Peter D; Anderson, Paul H

    2014-10-01

    Clinical studies indicate that the combination of vitamin D and dietary calcium supplementation is more effective for reducing fracture risk than either supplement alone. Our previous dietary studies demonstrated that an adequate serum 25-hydroxyvitamin D3 (25D) of 80nmol/L or more reduces bone RANKL expression, osteoclastogenesis and maintains the optimal levels of trabecular bone volume (BV/TV%) in young rats. The important clinical question of the interaction between vitamin D status, dietary calcium intake and age remains unclear. Hence, 9 month-old female Sprague-Dawley rats (n=5-6/group) were pair-fed a semi-synthetic diet containing varying levels of vitamin D (0, 2, 12 or 20IU/day) and dietary calcium (0.1% or 1%) for 6 months. At 15 months of age, animals were killed, for biochemical and skeletal analyses. While changes to serum 25D were determined by both dietary vitamin D and calcium levels, changes to serum 1,25-dihydroxyvitamin D3 (1,25D) were consistently raised in animals fed 0.1% Ca regardless of dietary vitamin D or vitamin D status. Importantly, serum cross-laps levels were significantly increased in animals fed 0.1% Ca only when combined with 0 or 2 IUD/day of vitamin D, suggesting a contribution of both dietary calcium and vitamin D in determining bone resorption activity. Serum 25(OH)D3 levels were positively correlated with both femoral mid-diaphyseal cortical bone volume (R(2)=0.24, P<0.01) and metaphyseal BV/TV% (R(2)=0.23, P<0.01, data not shown). In multiple linear regressions, serum 1,25(OH)2D3 levels were a negative determinant of CBV (R(2)=0.24, P<0.01) and were not a determinant of metaphyseal BV/TV% levels. These data support clinical data that reduced bone resorption and increased bone volume can only be achieved with adequate 25D levels in combination with high dietary calcium and low serum 1,25D levels. This article is part of a Special Issue entitled '16th Vitamin D Workshop'. PMID:24309068

  13. 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

  14. Resampling the N9741 Trial to Compare Tumor Dynamic Versus Conventional End Points in Randomized Phase II Trials

    PubMed Central

    Sharma, Manish R.; Gray, Elizabeth; Goldberg, Richard M.; Sargent, Daniel J.; Karrison, Theodore G.

    2015-01-01

    Purpose The optimal end point for randomized phase II trials of anticancer therapies remains controversial. We simulated phase II trials by resampling patients from N9741, a randomized phase III trial of chemotherapy regimens for metastatic colorectal cancer, and compared the power of various end points to detect the superior therapy (FOLFOX [infusional fluorouracil, leucovorin, and oxaliplatin] had longer overall survival than both IROX [irinotecan plus oxaliplatin] and IFL [irinotecan and bolus fluorouracil plus leucovorin]). Methods Tumor measurements and progression-free survival (PFS) data were obtained for 1,471 patients; 1,002 had consistently measured tumors and were resampled (5,000 replicates) to simulate two-arm, randomized phase II trials with α = 0.10 (one sided) and 20 to 80 patients per arm. End points included log ratio of tumor size at 6, 12, and 18 weeks relative to baseline; time to tumor growth (TTG), estimated using a nonlinear mixed-effects model; and PFS. Arms were compared using rank sum tests for log ratio and TTG and a log-rank test for PFS. Results For FOLFOX versus IFL, TTG and PFS had similar power, with both exceeding the power of log ratio at 18 weeks; for FOLFOX versus IROX, TTG and log ratio at 18 weeks had similar power, with both exceeding the power of PFS. The best end points exhibited > 80% power with 60 to 80 patients per arm. Conclusion TTG is a powerful end point for randomized phase II trials of cytotoxic therapies in metastatic colorectal cancer; it was either comparable or superior to PFS and log ratio at 18 weeks. Additional studies will be needed to clarify the potential of TTG as a phase II end point. PMID:25349295

  15. Some recommendations for multi-arm multi-stage trials.

    PubMed

    Wason, James; Magirr, Dominic; Law, Martin; Jaki, Thomas

    2016-04-01

    Multi-arm multi-stage designs can improve the efficiency of the drug-development process by evaluating multiple experimental arms against a common control within one trial. This reduces the number of patients required compared to a series of trials testing each experimental arm separately against control. By allowing for multiple stages experimental treatments can be eliminated early from the study if they are unlikely to be significantly better than control. Using the TAILoR trial as a motivating example, we explore a broad range of statistical issues related to multi-arm multi-stage trials including a comparison of different ways to power a multi-arm multi-stage trial; choosing the allocation ratio to the control group compared to other experimental arms; the consequences of adding additional experimental arms during a multi-arm multi-stage trial, and how one might control the type-I error rate when this is necessary; and modifying the stopping boundaries of a multi-arm multi-stage design to account for unknown variance in the treatment outcome. Multi-arm multi-stage trials represent a large financial investment, and so considering their design carefully is important to ensure efficiency and that they have a good chance of succeeding. PMID:23242385

  16. Some recommendations for multi-arm multi-stage trials

    PubMed Central

    Magirr, Dominic; Law, Martin; Jaki, Thomas

    2012-01-01

    Multi-arm multi-stage designs can improve the efficiency of the drug-development process by evaluating multiple experimental arms against a common control within one trial. This reduces the number of patients required compared to a series of trials testing each experimental arm separately against control. By allowing for multiple stages experimental treatments can be eliminated early from the study if they are unlikely to be significantly better than control. Using the TAILoR trial as a motivating example, we explore a broad range of statistical issues related to multi-arm multi-stage trials including a comparison of different ways to power a multi-arm multi-stage trial; choosing the allocation ratio to the control group compared to other experimental arms; the consequences of adding additional experimental arms during a multi-arm multi-stage trial, and how one might control the type-I error rate when this is necessary; and modifying the stopping boundaries of a multi-arm multi-stage design to account for unknown variance in the treatment outcome. Multi-arm multi-stage trials represent a large financial investment, and so considering their design carefully is important to ensure efficiency and that they have a good chance of succeeding. PMID:23242385

  17. 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

  18. Knowledge and Informed Decision-Making about Population-Based Colorectal Cancer Screening Participation in Groups with Low and Adequate Health Literacy.

    PubMed

    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

  19. Analytic Methods for Individually Randomized Group Treatment Trials and Group-Randomized Trials When Subjects Belong to Multiple Groups

    PubMed Central

    Andridge, Rebecca. R.; Shoben, Abigail B.; Muller, Keith E.; Murray, David M.

    2014-01-01

    Participants in trials may be randomized either individually or in groups, and may receive their treatment either entirely individually, entirely in groups, or partially individually and partially in groups. This paper concerns cases in which participants receive their treatment either entirely or partially in groups, regardless of how they were randomized. Participants in Group-Randomized Trials (GRTs) are randomized in groups and participants in Individually Randomized Group Treatment (IRGT) trials are individually randomized, but participants in both types of trials receive part or all of their treatment in groups or through common change agents. Participants who receive part or all of their treatment in a group are expected to have positively correlated outcome measurements. This paper addresses a situation that occurs in GRTs and IRGT trials – participants receive treatment through more than one group. As motivation, we consider trials in The Childhood Obesity Prevention and Treatment Research Consortium (COPTR), in which each child participant receives treatment in at least two groups. In simulation studies we considered several possible analytic approaches over a variety of possible group structures. A mixed model with random effects for both groups provided the only consistent protection against inflated type I error rates and did so at the cost of only moderate loss of power when intraclass correlations were not large. We recommend constraining variance estimates to be positive and using the Kenward-Roger adjustment for degrees of freedom; this combination provided additional power but maintained type I error rates at the nominal level. PMID:24399701

  20. 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

  1. Randomized controlled trials in frontotemporal dementia: cognitive and behavioral outcomes.

    PubMed

    Miller, Justin B; Banks, Sarah J; Léger, Gabriel C; Cummings, Jeffrey L

    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

  2. Patients' Attitudes and Preferences About Participation and Recruitment Strategies in Clinical Trials

    PubMed Central

    Sood, Amit; Prasad, Kavita; Chhatwani, Laveena; Shinozaki, Eri; Cha, Stephen S.; Loehrer, Laura L.; Wahner-Roedler, Dietlind L.

    2009-01-01

    OBJECTIVE: To assess attitudes of patients about participation in clinical trials. PATIENTS AND METHODS: This is a self-report survey of 400 patients who underwent general medical evaluations between September and November 2006 at a tertiary care academic medical center in Rochester, MN. We measured knowledge of access to clinical trials, attitudes toward participation, recruitment preferences, and beliefs about research integrity. RESULTS: Of 485 consecutive patients, 400 (82%) completed the survey. Previous participation in clinical trials was reported by 112 patients (28%). Most were unaware of online information about clinical trials (330 [82%]), were satisfied with their current knowledge (233 [58%]), expected their treating physician to inform them about current trials (304 [76%]), and showed equal interest in participating in conventional or complementary intervention trials (174 [44%]). Of the 400 respondents, 321 (80%) found it appropriate to be contacted by mail and 253 (63%) by telephone regarding study participation. Most patients (364 [91%]) wanted to be informed about research findings or else would not participate in future clinical trials (272 [68%]). The most frequently expected compensation was free parking (234 [58%]). Most thought that their safety (373 [93%]) and privacy (376 [94%]) would be guarded. CONCLUSION: Patients are interested in participating in clinical trials but commonly lack adequate information. If patients received more information (through their treating physicians), enrollment might improve. This single-site study has limited generalizability. Future studies involving a diverse group of patients from a broader geographic distribution will help provide more definitive results. PMID:19252111

  3. Tumor-infiltrating lymphocytes (TILs) are a powerful prognostic marker in patients with triple-negative breast cancer enrolled in the IBCSG phase III randomized clinical trial 22-00.

    PubMed

    Pruneri, Giancarlo; Gray, Kathryn P; Vingiani, Andrea; Viale, Giuseppe; Curigliano, Giuseppe; Criscitiello, Carmen; Láng, István; Ruhstaller, Thomas; Gianni, Lorenzo; Goldhirsch, Aron; Kammler, Roswitha; Price, Karen N; Cancello, Giuseppe; Munzone, Elisabetta; Gelber, Richard D; Regan, Meredith M; Colleoni, Marco

    2016-07-01

    The purpose of this study was to assess the prognostic and predictive value of tumor-infiltrating lymphocytes (TILs) in the triple-negative breast cancer (TNBC) cohort of the phase III IBCSG trial 22-00, comparing low-dose oral 'metronomic' cyclophosphamide-methotrexate maintenance chemotherapy (CM-maintenance) to no-CM-maintenance in early breast cancer. TILs were evaluated in full-face hematoxylin-and-eosin-stained sections of tumor samples confirmed centrally as TNBC (< 1 % of ER and PgR immunoreactivity and absence of HER2 overexpression or amplification). Mononuclear cells were evaluated in the stromal area within the borders of the invasive tumor. The primary endpoint was breast cancer-free interval (BCFI). Cox proportional hazards regression model assessed the association of BCFI and secondary endpoints with TILs score. In the 647 tumor samples, the median percentage of TILs was 18 % (IQR = 8-40 %), with 18 % having TILs ≥ 50 % (lymphocyte-predominant breast cancer, LPBC). At a median follow-up of 6.9 years, TILs were associated with better prognosis. For every 10 % increase of TILs, BCFI risk reduction was 13 % (HR 0.87, 95 % CI 0.79-0.95,P = 0.003). DFS, DRFI, and OS risk reductions were 11 % (P = 0.005), 16 % (P = 0.003), and 17 % (P < 0.001), respectively. Multivariable analysis confirmed the independent prognostic value of TILs. No significant TILs-by-treatment interaction was observed (P = 0.39) for associations of TILs with BCFI, although patients with LPBC receiving CM-maintenance had a greater breast cancer risk reduction (HR 0.64,95 % CI 0.23-1.78) than those with non-LPBC (TILs < 50 %) (HR 0.96, 95 % CI 0.67-1.40). TILs score is a potent prognostic factor in patients with TNBC. Low-dose chemotherapy confers a greater (not statistically significant) clinical benefit in patients with LPBC. PMID:27372069

  4. Minimally adequate mental health care and latent classes of PTSD symptoms in female Iraq and Afghanistan veterans.

    PubMed

    Hebenstreit, Claire L; Madden, Erin; Koo, Kelly H; Maguen, Shira

    2015-11-30

    Female veterans of Operations Enduring and Iraqi Freedom, and Operation New Dawn (OEF/OIF/OND) represent a growing segment of Department of Veterans Affairs (VA) health care users. A retrospective analysis used national VA medical records to identify factors associated with female OEF/OIF/OND veterans' completion of minimally adequate care (MAC) for PTSD, defined as the completion of at least nine mental health outpatient visits within a 15-week period or at least twelve consecutive weeks of medication use. The sample included female OEF/OIF/OND veterans with PTSD who initiated VA health care between 2007-2013, and were seen in outpatient mental health (N=2183). Multivariable logistic regression models examined factors associated with completing MAC for PTSD, including PTSD symptom expression (represented by latent class analysis), sociodemographic, military, clinical, and VA access factors. Within one year of initiating mental health care, 48.3% of female veterans completed MAC. Race/ethnicity, age, PTSD symptom class, additional psychiatric diagnoses, and VA primary care use were significantly associated with completion of MAC for PTSD. Results suggest that veterans presenting for PTSD treatment should be comprehensively evaluated to identify factors associated with inadequate completion of care. Treatments that are tailored to PTSD symptom class may help to address potential barriers. PMID:26330305

  5. Detailed NMR, Including 1,1-ADEQUATE, and Anticancer Studies of Compounds from the Echinoderm Colobometra perspinosa

    PubMed Central

    Wright, Anthony D.; Nielson, Jonathan L.; Tapiolas, Dianne M.; Motti, Cherie A.; Ovenden, Simon P. B.; Kearns, Philip S.; Liptrot, Catherine H.

    2009-01-01

    From the dichloromethane/methanol extract of the crinoid Colobometra perspinosa, collected south east of Richards Island (Bedara), Family Islands, Central Great Barrier Reef, Australia, 3-(1′-hydroxypropyl)-1,6,8-trihydroxy-9,10-anthraquinone [one of the two stereoisomers of rhodoptilometrin, (1)], 3-propyl-1,6,8-trihydroxy-9,10-anthraquinone (3), 2-[(phenylacetyl)amino]ethanesulfonic acid (4), and 4-hydroxybutanoic acid (5) were isolated. Comparison of 1H- and 13C-NMR data for rhodoptilometrin (1) with those reported in the literature showed significant differences for some resonances associated with rings A and C. In an attempt to provide accurately assigned 1H- and 13C-NMR data, as well as to confirm the structure of 1, a thorough NMR investigation of this compound was undertaken. Measurements included: concentration dependent 13C, 1D selective NOE, HSQC, HMBC and 1,1-ADEQUATE. The NMR data for 4 and 5 are reported here for the first time, as is their occurrence from the marine environment. The in vitro anticancer activity of the original extract was found to be associated with 1, 3 and 5. PMID:20098598

  6. Combination and triple therapy in patients with stable angina pectoris not adequately controlled by optimal β-blocker therapy

    PubMed Central

    Kok, W.E.M.; Visser, F.C.; Visser, C.A.

    2002-01-01

    In 60 to 80% of patients with stable angina pectoris at low risk for future coronary events, monotherapy with a β-blocker is an effective treatment. When patients with stable angina pectoris and low risk for events do not respond adequately to optimal β-blocker monotherapy, combination therapy or even triple therapy is may be recommended, but little is known of the actual benefit of such a strategy. We reviewed the evidence from the literature on the effectiveness of combination and triple therapy. Combination therapy with a calcium antagonist or nitrate was found to be more effective than β-blocker monotherapy in the majority of studies, but only an estimated 30% of patients objectively benefit from these combination therapies. Direct comparison shows that combination therapy of a β-blocker with a calcium antagonist is more effective than the combination of a β-blocker with a nitrate. An inadequate response to β-blocker monotherapy is more effectively improved by addition of a calcium antagonist than by alternative use of a calcium antagonist. The use of triple therapy is controversial and not recommended in patients with mild angina pectoris, while for patients with severe angina pectoris not responding to combination therapy of a β-blocker with a nitrate, triple therapy may be of advantage, although the number of patients studied has been small. PMID:25696045

  7. 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. PMID:22681564

  8. 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. PMID:26818993

  9. New vessel formation in the context of cardiomyocyte regeneration – the role and importance of an adequate perfusing vasculature

    PubMed Central

    Michelis, Katherine C.; Boehm, Manfred; Kovacic, Jason C.

    2014-01-01

    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. PMID:24841067

  10. Evaluating adherence to the International Committee of Medical Journal Editors’ policy of mandatory, timely clinical trial registration

    PubMed Central

    Huser, Vojtech; Cimino, James J

    2013-01-01

    . This new integrated knowledge source can facilitate research prioritization, clinical guidelines creation, and precision medicine. Conclusions The five selected journals adhere well to the policy of mandatory trial registration and also outperform the registry in adherence to timely registration. ICMJE's URM policy represents a unique international mandate that may be providing a powerful incentive for sponsors and investigators to document clinical trials and trial result publications and thus fulfill important obligations to trial participants and society. PMID:23396544

  11. Gateways to clinical trials.

    PubMed

    Bayés, M; Rabasseda, X; Prous, J R

    2007-12-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Intergrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 249553, 2-Methoxyestradiol; Abatacept, Adalimumab, Adefovir dipivoxil, Agalsidase beta, Albinterferon alfa-2b, Aliskiren fumarate, Alovudine, Amdoxovir, Amlodipine besylate/atorvastatin calcium, Amrubicin hydrochloride, Anakinra, AQ-13, Aripiprazole, AS-1404, Asoprisnil, Atacicept, Atrasentan; Belimumab, Bevacizumab, Bortezomib, Bosentan, Botulinum toxin type B, Brivaracetam; Catumaxomab, Cediranib, Cetuximab, cG250, Ciclesonide, Cinacalcet hydrochloride, Curcumin, Cypher; Darbepoetin alfa, Denosumab, Dihydrexidine; Eicosapentaenoic acid/docosahexaenoic acid, Entecavir, Erlotinib hydrochloride, Escitalopram oxalate, Etoricoxib, Everolimus, Ezetimibe; Febuxostat, Fenspiride hydrochloride, Fondaparinux sodium; Gefitinib, Ghrelin (human), GSK-1562902A; HSV-tk/GCV; Iclaprim, Imatinib mesylate, Imexon, Indacaterol, Insulinotropin, ISIS-112989; L-Alanosine, Lapatinib ditosylate, Laropiprant; Methoxy polyethylene glycol-epoetin-beta, Mipomersen sodium, Motexafin gadolinium; Natalizumab, Nimotuzumab; OSC, Ozarelix; PACAP-38, Paclitaxel nanoparticles, Parathyroid Hormone-Related Protein-(1-36), Pasireotide, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Pertuzumab, Picoplatin, Pimecrolimus, Pitavastatin calcium, Plitidepsin; Ranelic acid distrontium salt, Ranolazine, Recombinant human relaxin H2, Regadenoson, RFB4(dsFv)-PE38, RO-3300074, Rosuvastatin calcium; SIR-Spheres, Solifenacin succinate, Sorafenib, Sunitinib malate; Tadalafil, Talabostat, Taribavirin hydrochloride, Taxus, Temsirolimus, Teriparatide, Tiotropium bromide, Tipifarnib, Tirapazamine, Tocilizumab; UCN-01, Ularitide

  12. Gateways to clinical trials.

    PubMed

    Tomillero, A; Moral, M A

    2010-11-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Thomson Reuters Integrity(SM), the drug discovery and development portal, http://www.thomsonreutersintegrity.com. This issue focuses on the following selection of drugs: Abatacept, Adalimumab, AdCD40L, Adefovir, Aleglitazar, Aliskiren fumarate, AM-103, Aminolevulinic acid methyl ester, Amlodipine, Anakinra, Aprepitant, Aripiprazole, Atazanavir sulfate, Axitinib; Belimumab, Bevacizumab, Bimatoprost, Bortezomib, Bupropion/naltrexone; Calcipotriol/betamethasone dipropionate, Certolizumab pegol, Ciclesonide, CYT-997; Darbepoetin alfa, Darunavir, Dasatinib, Desvenlafaxine succinate, Dexmethylphenidate hydrochloride cogramostim; Eltrombopag olamine, Emtricitabine, Escitalopram oxalate, Eslicarbazepine acetate, Eszopiclone, Etravirine, Everolimus-eluting coronary stent, Exenatide, Ezetimibe; Fenretinide, Filibuvir, Fludarabine; Golimumab; Hepatitis B hyperimmunoglobulin, HEV-239, HP-802-247, HPV-16/18 AS04, HPV-6/11/16/18, Human albumin, Human gammaglobulin; Imatinib mesylate, Inotuzumab ozogamicin, Invaplex 50 vaccine; Lapatinib ditosylate, Lenalidomide, Liposomal doxorubicin, Lopinavir, Lumiliximab, LY-686017; Maraviroc, Mecasermin rinfabate; Narlaprevir; Ocrelizumab, Oral insulin, Oritavancin, Oxycodone hydrochloride/naloxone; Paclitaxel-eluting stent, Palonosetron hydrochloride, PAN-811, Paroxetine, Pazopanib hydrochloride, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Pertuzumab, Pitavastatin calcium, Posaconazole, Pregabalin, Prucalopride succinate; Raltegravir potassium, Ranibizumab, RHAMM R3 peptide, Rosuvastatin calcium; Salclobuzic acid sodium salt, SCY-635, Selenate sodium, Semapimod hydrochloride, Silodosin, Siltuximab, Silybin, Sirolimus-eluting stent, SIR-Spheres, Sunitinib malate; Tapentadol hydrochloride, Tenofovir disoproxil

  13. Gateways to clinical trials.

    PubMed

    Tomillero, A; Moral, M A

    2008-10-01

    Gateways to clinical trials is a guide to the most recent trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity(R), the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: (+)-Dapoxetine hydrochloride, (S)-Tenatoprazole sodium salt monohydrate 19-28z, Acotiamide hydrochloride hydrate, ADV-TK, AE-37, Aflibercept, Albinterferon alfa-2b, Aliskiren fumarate, Asenapine maleate, Axitinib; Bavituximab, Becatecarin, beta-1,3/1,6-Glucan, Bevacizumab, Bremelanotide; Calcipotriol/betamethasone dipropionate, Casopitant mesylate, Catumaxomab, CDX-110, Cediranib, CMD-193, Cositecan; Darinaparsin, Denosumab, DP-b99, Duloxetine hydrochloride; E75, Ecogramostim, Elacytarabine, EMD-273063, EndoTAG-1, Enzastaurin hydrochloride, Eplerenone, Eribulin mesilate, Esomeprazole magnesium, Etravirine, Everolimus, Ezetimibe; Faropenem daloxate, Febuxostat, Fenretinide; Ghrelin (human); I-131 ch-TNT-1/B, I-131-3F8, Iclaprim, Iguratimod, Iloperidone, Imatinib mesylate, Inalimarev/Falimarev, Indacaterol, Ipilimumab, Iratumumab, Ispinesib mesylate, Ixabepilone; Lapatinib ditosylate, Laquinimod sodium, Larotaxel dehydrate, Linezolid, LOR-2040; Mapatumumab, MKC-1, Motesanib diphosphate, Mycophenolic acid sodium salt; NK-012; Olanzapine pamoate, Oncolytic HSV, Ortataxel; Paclitaxel nanoparticles, Paclitaxel poliglumex, Paliperidone palmitate, Panitumumab, Patupilone, PCV-9, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Pertuzumab, Picoplatin, Pimavanserin tartrate, Pimecrolimus, Plerixafor hydrochloride, PM-02734, Poly I:CLC, PR1, Prasugrel, Pregabalin, Progesterone caproate, Prucalopride, Pumosetrag hydrochloride; RAV-12, RB-006, RB-007, Recombinant human erythropoietin alfa, Rimonabant, Romidepsin; SAR-109659, Satraplatin, Sodium butyrate; Tadalafil, Talampanel, Tanespimycin, Tarenflurbil, Tariquidar

  14. Gateways to clinical trials.

    PubMed

    Bayés, M; Rabasseda, X; Prous, J R

    2006-05-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in 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 issue focuses on the following selection of drugs: Adalimumab, adenosine triphosphate, alemtuzumab, alendronate sodium/cholecalciferol, aliskiren fumarate, AMGN-0007, aminolevulinic acid methyl ester, anakinra, anidulafungin, aripiprazole, atomoxetine hydrochloride; Bevacizumab, bosentan; Calcipotriol/beta methasone dipropionate, caldaret hydrate, caspofungin acetate, cetuximab, cinacalcet hydrochloride, clopidogrel, cocaine-BSA conjugate, conivaptan hydrochloride, Cypher; Darbepoetin alfa, delmitide, desloratadine, desmoteplase, desoxyepothilone B, disufenton sodium, DU-176b, duloxetine hydrochloride, dutasteride; EBV-specific CTLs, ecogramostim, edodekin alfa, efalizumab, eletriptan, emtricitabine, entecavir, erlotinib hydrochloride, ertapenem sodium, escitalopram oxalate, etoricoxib, everolimus, ezetimibe; Fanapanel, fondaparinux sodium; Gefitinib, GTI-2040, GW-501516; Her2 E75-peptide vaccine, human insulin; Ibogaine, icatibant acetate, Id-KLH vaccine, imatinib mesylate, immune globulin subcutaneous [human], indacaterol, inolimomab, ipilimumab, i.v. gamma-globulin, ivabradine hydrochloride, ixabepilone; Lacosamide, lanthanum carbonate, lenalidomide, levocetirizine, levodopa methyl ester hydrochloride/carbidopa, levodopa/carbidopa/entacapone, lidocaine/prilocaine; Maraviroc, mecasermin, melevodopa hydrochloride, mepolizumab, mitumomab; Nesiritide; Omalizumab, oral insulin; Parathyroid hormone (human recombinant), patupilone, pegaptanib sodium, PEG-filgrastim, pemetrexed disodium, photochlor, pimecrolimus, posaconazole, prasterone, prasugrel, pregabalin, prilocaine, PRX-00023; QS-21; Ranibizumab, ranirestat, rhodamine 123, rotigaptide; Sarcosine, sirolimus

  15. Gateways to clinical trials.

    PubMed

    Bayés, M; Rabasseda, X; Prous, J R

    2006-01-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in 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 issue focuses on the following selection of drugs: ABT-510, adalimumab, alefacept, ambrisentan, aminolevulinic acid methyl ester, armodafinil, aselizumab, asenapine maleate, azelnidipine; Bevacizumab, bexarotene, bimosiamose, biphasic insulin aspart, bortezomib, bosentan, BQ-123; C340, cannabidiol, caspofungin acetate, CC-4047, certolizumab pegol, cetuximab, ciclesonide, cilansetron, Cypher; Dabigatran etexilate, darbepoetin alfa, darifenacin hydrobromide, desloratadine, dexosome vaccine (melanoma), dimethyl fumarate, dronabinol/cannabidiol, drospirenone, drospirenone/estradiol, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Efalizumab, eglumetad hydrate, emoxipin hydrochloride, eplerenone, erlotinib hydrochloride, escitalopram oxalate, etonogestrel/ethinylestradiol; Garenoxacin mesilate, gamma-hydroxybutyrate sodium, gefitinib; H5N1 pandemic influenza vaccine, human growth hormone-(177-191), human insulin; Indacaterol, INKP-100, INKP-102, insulin glargine, i.v. gamma-globulin; KLH; Lapatinib, L-arginine hydrochloride, lasofoxifene tartrate, levocetirizine, licochalcone A, LMI vaccine, lomefloxacin, lubiprostone, lumiracoxib; Miglustat, mycograb; Natalizumab, NCX-4016, nortopixantrone hydrochloride; Olmesartan medoxomil, omalizumab, oral insulin, OrM3; Parathyroid hormone (human recombinant), parecoxib sodium, PCK-3145, PEG-filgrastim, peginterferon alfa-2a, pemetrexed disodium, pexelizumab, photochlor, pimecrolimus, pneumococcal 7-valent conjugate vaccine, polyphenon E; R-126638, R-411, resveratrol, roflumilast, RS-86, ruboxistaurin mesilate hydrate, rupatadine fumarate; Sipuleucel-T, somatropin, St. John's Wort extract; Tadalafil, Taxus

  16. Gateways to clinical trials.

    PubMed

    Bayes, M; Rabasseda, X; Prous, J R

    2006-01-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in 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 issue focuses on the following selection of drugs:(R)-Flurbiprofen, 90Yttrium-DOTA-huJ591; ABT-510, ACP-103, Ad5-FGF4, adalimumab, ademetionine, AG-7352, alemtuzumab, Amb a 1 ISS-DNA, anakinra, apaziquone, aprepitant, aripiprazole, atazanavir sulfate; BAL-8557, bevacizumab, BMS-188797, bortezomib, bosentan, brivudine; Calcipotriol/betamethasone dipropionate, cannabidiol, caspofungin acetate, catumaxomab, CERE-120, cetuximab, ciclesonide, cilomilast, cizolirtine citrate, Cypher, cystemustine; Dalbavancin, darifenacin hydrobromide, dasatinib, deferasirox, denosumab, desmoteplase, dihydrexidine, dimethyl fumarate, dutasteride, DW-166HC; Eculizumab, enfuvirtide, entecavir, epratuzumab, erlotinib hydrochloride, escitalopram oxalate, eszopiclone, etoricoxib, everolimus; Fallypride, febuxostat, fenretinide, fesoterodine, fingolimod hydrochloride; Gabapentin enacarbil, gefitinib; hMaxi-K, human papillomavirus vaccine, HYAL-CT1101; Imatinib mesylate, indiplon, inolimomab, ISAtx-247; J591; Lacosamide, landiolol, lasofoxifene tartrate, lestaurtinib, lidocaine/prilocaine, linezolid, lixivaptan, lonafarnib, lopinavir, lopinavir/ritonavir, lumiracoxib; Natalizumab, nesiritide; OC-108, omalizumab, onercept, OSC; Palifermin, palonosetron hydrochloride, parathyroid hormone (human recombinant), parecoxib sodium, PD-MAGE-3 vaccine, PEG-filgrastim, peginterferon alfa-2a, peginterferon alfa-2b, pegsunercept, pelitinib, pitavastatin calcium, plerixafor hydrochloride, posaconazole, prasterone sulfate, pregabalin; Ramelteon, ranelic acid distrontium salt, rasburicase, rosuvastatin calcium, rotigotine, RSD-1235, rufinamide, rupatadine fumarate; Sarizotan hydrochloride, SHL-749

  17. Gateways to clinical trials.

    PubMed

    Moral, M A; Tomillero, A

    2008-03-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 131-I-Chlorotoxin, 423557; Abatacept, Ad.Egr.TNF.11D, Adalimumab, AE-941, Ambrisentan, AMR-001, Anacetrapib, Anakinra, Aripiprazole, Atazanavir sulfate; BAY-639044, Bazedoxifene acetate, Belimumab, Bevacizumab, Bortezomib, Botulinum toxin type B, Brivaracetam, Bucindolol hydrochloride; Carfilzomib, Carisbamate, CCX-282, CD20Bi, Ceftobiprole, Certolizumab pegol, CF-101, Cinacalcet hydrochloride, Cypher; Darifenacin hydrobromide, Degarelix acetate, Denosumab, Desvenlafaxine succinate, Dexlansoprazole, Dexverapamil, Drotrecogin alfa (activated), Duloxetine hydrochloride, Dutasteride; Efalizumab, EPs-7630, Escitalopram oxalate, Etoricoxib; Fluticasone furoate, Fondaparinux sodium, Fospropofol disodium; Hexadecyloxypropyl-cidofovir, HIV gp120/NefTat/AS02A, HPV-6/11/16/18; INCB-18424, Incyclinide, Inhalable human insulin, Insulin detemir; KNS-760704, KW-0761; Lacosamide, Lenalidomide, Levetiracetam, Licofelone, Lidocaine/prilocaine; mAb 216, MEDI-528, Men ACWY, Meningococcal C-CRM197 vaccine, Methylnaltrexone bromide; Nemifitide ditriflutate, Nicotine conjugate vaccine, Nilotinib hydrochloride monohydrate; Octaparin; Parathyroid hormone (human recombinant), Pegaptanib octasodium, Pitrakinra, Prasterone, Pregabalin; Ranelic acid distrontium salt, Rasagiline mesilate, Retigabine, Rimonabant, RTS,S/AS02D; Sarcosine, Sitaxentan sodium, Solifenacin succinate, Sunitinib malate; Taranabant, Taxus, Teduglutide, Teriparatide, Ticagrelor, Travoprost, TRU-015; USlipristal acetate, Urocortin 2; Vardenafil hydrochloride hydrate; YM-155, Yttrium 90 (90Y) ibritumomab tiuxetan; Zanolimumab, Zoledronic acid monohydrate, Zotarolimus

  18. Gateways to clinical trials.

    PubMed

    Bayes, M; Rabasseda, X; Prous, J R

    2006-09-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in 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 issue focuses on the following selection of drugs: A-007, A6, adalimumab, adenosine triphosphate, alefacept, alemtuzumab, AllerVax Ragweed, amphora, anakinra, angiotensin-(1-7), anidulafungin, apomine, aripiprazole, atomoxetine hydrochloride, avanafil; BAL-8557, becatecarin, bevacizumab, biphasic insulin aspart, BMS-188797, bortezomib, bosentan, botulinum toxin type B, brivudine; Calcipotriol/betamethasone dipropionate, caspofungin acetate, catumaxomab, certolizumab pegol, cetuximab, CG-0070, ciclesonide, cinacalcet hydrochloride, clindamycin phosphate/benzoyl peroxide, cryptophycin 52, Cypher; Dabigatran etexilate, darapladib, darbepoetin alfa, decitabine, deferasirox, desloratadine, dexanabinol, dextromethorphan/quinidine sulfate, DMF, drotrecogin alfa (activated), duloxetine hydrochloride; E-7010, edaravone, efalizumab, emtricitabine, entecavir, eplerenone, erlotinib hydrochloride, escitalopram oxalate, estradiol valerate/dienogest, eszopiclone, exenatide, ezetimibe; Fondaparinux sodium, fulvestrant; Gefitinib, gestodene, GYKI-16084; Hyaluronic acid, hydralazine hydrochloride/isosorbide dinitrate; Imatinib mesylate, indiplon, insulin glargine; Juzen-taiho-to; Lamivudine/zidovudine/abacavir sulfate, L-arginine hydrochloride, lasofoxifene tartrate, L-BLP-25, lenalidomide, levocetirizine, levodopa/carbidopa/entacapone, lexatumumab, lidocaine/prilocaine, lubiprostone, lumiracoxib; MAb-14.18, mitoquidone; Natalizumab, neridronic acid, neuradiab; Olpadronic acid sodium salt, omalizumab; p53-DC vaccine, parathyroid hormone (human recombinant), peginterferon alfa-2a, peginterferon alfa-2b, pemetrexed disodium, perifosine, pimecrolimus, prasterone, prasugrel, PRO-2000

  19. Gateways to clinical trials.

    PubMed

    Tomillero, A; Moral, M A

    2010-12-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Thomson Reuters Integrity(SM), the drug discovery and development portal, http://www.thomsonreutersintegrity.com. This issue focuses on the following selection of drugs: 17-Hydroxyprogesterone caproate; Abacavir sulfate/lamivudine, Aclidinium bromide, Adalimumab, Adefovir, Alemtuzumab, Alkaline phosphatase, Amlodipine, Apilimod mesylate, Aripiprazole, Axitinib, Azacitidine; Belotecan hydrochloride, Berberine iodide, Bevacizumab, Bortezomib, Bosentan, Bryostatin 1; Calcipotriol/hydrocortisone, Carglumic acid, Certolizumab pegol, Cetuximab, Cinacalcet hydrochloride, Cixutumumab, Coumarin, Custirsen sodium; Darbepoetin alfa, Darifenacin hydrobromide, Darunavir, Dasatinib, Denibulin hydrochloride, Denosumab, Diacetylmorphine, Dulanermin, Duloxetine hydrochloride; Ecogramostim, Enfuvirtide, Entecavir, Enzastaurin hydrochloride, Eplerenone, Escitalopram oxalate, Esomeprazole sodium, Etravirine, Everolimus, Ezetimibe; Fenofibrate/pravastatin sodium, Ferric carboxymaltose, Flavangenol, Fondaparinux sodium; Glutamine, GSK-1024850A; Hepatitis B hyperimmunoglobulin, Hib-MenC, HIV-LIPO-5; Immunoglobulin intravenous (human), Indacaterol maleate, Indibulin, Indium 111 (¹¹¹In) ibritumomab tiuxetan, Influenza A (H1N1) 2009 Monovalent vaccine, Inhalable human insulin, Insulin glulisine; Lapatinib ditosylate, Leucovorin/UFT; Maraviroc, Mecasermin, MMR-V, Morphine hydrochloride, Morphine sulfate/naltrexone hydrochloride, Mycophenolic acid sodium salt; Naproxen/esomeprazole magnesium, Natalizumab; Oncolytic HSV; Paliperidone, PAN-811, Paroxetine, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b/ribavirin, Pegvisomant, Pemetrexed disodium, Pimecrolimus, Posaconazole, Pregabalin; Raltegravir potassium, Ranelic acid distrontium salt, Rasburicase, Rilpivirine

  20. Gateways to clinical trials.

    PubMed

    Bayes, M; Rabasseda, X; Prous, J R

    2004-01-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Know- ledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: ABI-007, Ad.Egr.TNF.11D, adefovir dipivoxil, AdPEDF.11, AES-14, albumex, alefacept, alemtuzumab, aliskiren fumarate, alvimopan hydrate, aAminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, anakinra, anti-IL-12 MAb, aprepitant, atazanavir sulfate, atrasentan, avanafil; Banoxantrone, BG-12, bimatoprost, bortezomib, bosentan; Calcipotriol/betamethasone dipropionate, caspofungin acetate, CBT-1, ciclesonide, clofarabine, conivaptan hydrochloride, CpG-7909, C-Vax, Cypher; DA-8159, DAC:GLP-1, darbepoetin alfa, darifenacin, duloxetine hydrochloride; Eculizumab, efalizumab, efaproxiral sodium, EGF vaccine, eletriptan, epratuzumab, erlotinib hydrochloride, escitalopram oxalate, ETC-642, etoricoxib, everolimus, exenatide; Gefitinib, IV gamma-globulin; Human insulin, gamma-hydroxybutyrate sodium; IDN-6556, iguratimod, imatinib mesylate, indiplon, ixabepilone; Laquinimod, LB-80380, lidocaine/prilocaineliraglutide, lopinavir, lopinavir/ritonavir, lucinactant; MAb-14.18, melatonin, MLN-591-DM1; NC-531, neridronic acid, nesiritide, neutrophil-inhibitory factor, niacin/lovastatin; Oblimersen sodium, olcegepant, oral Insulin, ORV-105; Palonosetron hydrochloride, PAmAb, pegaptanib sodium, peginterferon alfa-2a, pegvisomant, perifosine, pexelizumab, phenoxodiol, phenserine tartrate, pimecrolimus, pramlintide acetate, pregabalin, PRO-542, prostate cancer vaccine, PT-141; Ramelteon, rasagiline mesilate, rDNA insulin, reslizumab, rh-Lactoferrin, ribamidine hydrochloride, rosuvastatin calcium; S-8184l, SC-1, sorafenib, St. John's Wort extract, SU-11248; Taxus, telbivudine, tenofovir disoproxil fumarate, teriparatide