WorldWideScience

Sample records for subjects randomly assigned

  1. Random Cell Identifiers Assignment

    Directory of Open Access Journals (Sweden)

    Robert Bestak

    2012-01-01

    Full Text Available Despite integration of advanced functions that enable Femto Access Points (FAPs to be deployed in a plug-and-play manner, the femtocell concept still cause several opened issues to be resolved. One of them represents an assignment of Physical Cell Identifiers (PCIs to FAPs. This paper analyses a random based assignment algorithm in LTE systems operating in diverse femtocell scenarios. The performance of the algorithm is evaluated by comparing the number of confusions for various femtocell densities, PCI ranges and knowledge of vicinity. Simulation results show that better knowledge of vicinity can significantly reduce the number of confusions events.

  2. The Random Quadratic Assignment Problem

    Science.gov (United States)

    Paul, Gerald; Shao, Jia; Stanley, H. Eugene

    2011-11-01

    The quadratic assignment problem, QAP, is one of the most difficult of all combinatorial optimization problems. Here, we use an abbreviated application of the statistical mechanics replica method to study the asymptotic behavior of instances in which the entries of at least one of the two matrices that specify the problem are chosen from a random distribution P. Surprisingly, the QAP has not been studied before using the replica method despite the fact that the QAP was first proposed over 50 years ago and the replica method was developed over 30 years ago. We find simple forms for C min and C max , the costs of the minimal and maximum solutions respectively. Notable features of our results are the symmetry of the results for C min and C max and their dependence on P only through its mean and standard deviation, independent of the details of P.

  3. A Search for Alternatives to Random Assignment to Treatment Groups.

    Science.gov (United States)

    Halasa, Ofelia

    In a public school setting administrators are frequently under local pressure to make a new project service available to all eligible children. However, comparable control groups for project evaluation are often absent, and although random assignment to treatment groups remains the most systematic method of providing controls, this is not often…

  4. Sequential multiple assignment randomization trials with enrichment design.

    Science.gov (United States)

    Liu, Ying; Wang, Yuanjia; Zeng, Donglin

    2017-06-01

    Sequential multiple assignment randomization trial (SMART) is a powerful design to study Dynamic Treatment Regimes (DTRs) and allows causal comparisons of DTRs. To handle practical challenges of SMART, we propose a SMART with Enrichment (SMARTER) design, which performs stage-wise enrichment for SMART. SMARTER can improve design efficiency, shorten the recruitment period, and partially reduce trial duration to make SMART more practical with limited time and resource. Specifically, at each subsequent stage of a SMART, we enrich the study sample with new patients who have received previous stages' treatments in a naturalistic fashion without randomization, and only randomize them among the current stage treatment options. One extreme case of the SMARTER is to synthesize separate independent single-stage randomized trials with patients who have received previous stage treatments. We show data from SMARTER allows for unbiased estimation of DTRs as SMART does under certain assumptions. Furthermore, we show analytically that the efficiency gain of the new design over SMART can be significant especially when the dropout rate is high. Lastly, extensive simulation studies are performed to demonstrate performance of SMARTER design, and sample size estimation in a scenario informed by real data from a SMART study is presented. © 2016, The International Biometric Society.

  5. The Designer-by-Assignment in Practice: Instructional Design Thinking of Subject Matter Experts

    Science.gov (United States)

    Pesce, Sandra V.

    2012-01-01

    Designers-by-assignment, or subject matter experts (SMEs) who are pressed into training service, have become common in the workplace. A review of more than 24 studies on expert and novice instructional designers, however, revealed that little is known about how designers-by-assignment think about design and make design decisions in the field. A…

  6. Randomized Assignments for Barter Exchanges: Fairness vs Efficiency

    DEFF Research Database (Denmark)

    Fang, Wenyi; Filos-Ratsikas, Aris; Frederiksen, Søren Kristoffer Stiil

    2015-01-01

    often restrict the maximum allowed cycle-length of the exchange and for randomized algorithms, this imposes constraints of the cycle-length of every realized exchange in their decomposition. We prove that standard fairness properties such as envy-freeness or symmetry are incompatible with even...... the weakest notion of economic efficiency in this setting. On the plus side, we adapt some well-known matching mechanisms to incorporate the restricted cycle constraint and evaluate their performance experimentally on instances of the kidney exchange problem, showing tradeoffs between fairness and efficiency....

  7. Algorithm for generation pseudo-random series with arbitrarily assigned distribution law

    Directory of Open Access Journals (Sweden)

    В.С. Єременко

    2005-04-01

    Full Text Available  Method for generation pseudo-random series with arbitrarily assigned distribution law has been proposed. The praxis of using proposed method for generation pseudo-random series with anti-modal and approximate to Gaussian distribution law has been investigated.

  8. Transcranial cerebral oximetry in random normal subjects

    Science.gov (United States)

    Misra, Mukesh; Stark, Jennifer; Dujovny, Manuel; Alp, M. Serdar; Widman, Ronald; Ausman, James I.

    1997-08-01

    Near infrared optical spectroscopy is becoming a useful method for monitoring regional cerebral oxygenation status. The method is simple, reliable and noninvasive and the information which it provides is clinically significant in managing a growing number of neurological ailments. Use of this technique has been described previously by numerous authors. In the present study, regional cerebral oxygen saturation was measured at rest in 94 subjects randomly elected from a diverse population of individuals. This sample consisted of 38 males and 65 females, with the age ranging from 18 - 70. There were 68 light-skinned individuals and 35 with darker skin comprising various ethnic and cultural backgrounds. Mean regional cerebral hemoglobin oxygen saturation was recorded as 67.14 plus or minus 8.84%. The association of the mean regional cerebral hemoglobin oxygen saturation in various group of individuals in relationship of their age, race, sex and skin color is examined.

  9. Calculation of Flight Deck Interval Management Assigned Spacing Goals Subject to Multiple Scheduling Constraints

    Science.gov (United States)

    Robinson, John E.

    2014-01-01

    The Federal Aviation Administration's Next Generation Air Transportation System will combine advanced air traffic management technologies, performance-based procedures, and state-of-the-art avionics to maintain efficient operations throughout the entire arrival phase of flight. Flight deck Interval Management (FIM) operations are expected to use sophisticated airborne spacing capabilities to meet precise in-trail spacing from top-of-descent to touchdown. Recent human-in-the-loop simulations by the National Aeronautics and Space Administration have found that selection of the assigned spacing goal using the runway schedule can lead to premature interruptions of the FIM operation during periods of high traffic demand. This study compares three methods for calculating the assigned spacing goal for a FIM operation that is also subject to time-based metering constraints. The particular paradigms investigated include: one based upon the desired runway spacing interval, one based upon the desired meter fix spacing interval, and a composite method that combines both intervals. These three paradigms are evaluated for the primary arrival procedures to Phoenix Sky Harbor International Airport using the entire set of Rapid Update Cycle wind forecasts from 2011. For typical meter fix and runway spacing intervals, the runway- and meter fix-based paradigms exhibit moderate FIM interruption rates due to their inability to consider multiple metering constraints. The addition of larger separation buffers decreases the FIM interruption rate but also significantly reduces the achievable runway throughput. The composite paradigm causes no FIM interruptions, and maintains higher runway throughput more often than the other paradigms. A key implication of the results with respect to time-based metering is that FIM operations using a single assigned spacing goal will not allow reduction of the arrival schedule's excess spacing buffer. Alternative solutions for conducting the FIM operation

  10. Color Charts, Esthetics, and Subjective Randomness

    Science.gov (United States)

    Sanderson, Yasmine B.

    2012-01-01

    Color charts, or grids of evenly spaced multicolored dots or squares, appear in the work of modern artists and designers. Often the artist/designer distributes the many colors in a way that could be described as "random," that is, without an obvious pattern. We conduct a statistical analysis of 125 "random-looking" art and design color charts and…

  11. Study on MAX-MIN Ant System with Random Selection in Quadratic Assignment Problem

    Science.gov (United States)

    Iimura, Ichiro; Yoshida, Kenji; Ishibashi, Ken; Nakayama, Shigeru

    Ant Colony Optimization (ACO), which is a type of swarm intelligence inspired by ants' foraging behavior, has been studied extensively and its effectiveness has been shown by many researchers. The previous studies have reported that MAX-MIN Ant System (MMAS) is one of effective ACO algorithms. The MMAS maintains the balance of intensification and diversification concerning pheromone by limiting the quantity of pheromone to the range of minimum and maximum values. In this paper, we propose MAX-MIN Ant System with Random Selection (MMASRS) for improving the search performance even further. The MMASRS is a new ACO algorithm that is MMAS into which random selection was newly introduced. The random selection is one of the edgechoosing methods by agents (ants). In our experimental evaluation using ten quadratic assignment problems, we have proved that the proposed MMASRS with the random selection is superior to the conventional MMAS without the random selection in the viewpoint of the search performance.

  12. The Use of Randomization Tests in Single-Subject Research

    Science.gov (United States)

    Haardorfer, Regine; Gagne, Phill

    2010-01-01

    Some researchers have argued for the use of or have attempted to make use of randomization tests in single-subject research. To address this tide of interest, the authors of this article describe randomization tests, discuss the theoretical rationale for applying them to single-subject research, and provide an overview of the methodological…

  13. Teacher-Child Interaction Training: A Pilot Study With Random Assignment.

    Science.gov (United States)

    Fernandez, Melanie A; Adelstein, Jonathan S; Miller, Samantha P; Areizaga, Margaret J; Gold, Dylann C; Sanchez, Amanda L; Rothschild, Sara A; Hirsch, Emily; Gudiño, Omar G

    2015-07-01

    Teacher-Child Interaction Training (TCIT), adapted from Parent-Child Interaction Therapy (PCIT), is a classroom-based program designed to provide teachers with behavior management skills that foster positive teacher-student relationships and to improve student behavior by creating a more constructive classroom environment. The purpose of this pilot study was to evaluate TCIT in more classrooms than previously reported in the literature, with older children than previously reported, using random assignment of classrooms to TCIT or to a no-TCIT control condition and conducting all but two sessions within the classroom to enhance feasibility. Participants included 11 kindergarten and first grade classroom teachers and their 118 students from three urban, public schools in Manhattan, with five classrooms randomly assigned to receive TCIT and six to the no-TCIT control condition. Observations of teacher skill acquisition were conducted before, during, and after TCIT for all 11 teachers, and teacher reports of student behavior were obtained at these same time points. Teacher satisfaction with TCIT was assessed following training. Results suggested that after receiving TCIT, teachers increased rates of positive attention to students' appropriate behavior, decreased rates of negative attention to misbehavior, reported significantly less distress related to student disruptive behavior, and reported high satisfaction with the training program. Our study supports the growing evidence-base suggesting that TCIT is a promising approach for training teachers in positive behavior management strategies and for improving student disruptive behavior in the classroom. Copyright © 2015. Published by Elsevier Ltd.

  14. Homework as Serious Family Business: Power and Subjectivity in Negotiations about School Assignments in Swedish Families

    Science.gov (United States)

    Forsberg, Lucas

    2007-01-01

    Most previous research on parental involvement in children's homework has focused on the pedagogical advantages or disadvantages of school assignments while neglecting the practice in its social context, family life. By studying parent-child homework negotiations in Swedish families, this paper examines how family members position themselves and…

  15. THE ASSIGNMENT OF SUBJECTS TO DISEASE PRONE PERSONALITY-TYPES - A COMMENT ON SCHMITZ

    NARCIS (Netherlands)

    RANCHOR, AV; SANDERMAN, R; BOUMA, J

    1992-01-01

    In this paper the assignment procedure is discussed which has been used in the study of Schmitz (1992; Personality and Individual Differences, 13, 683-691) investigating the relation between the personality types of Grossarth Maticek and Eysenck and various physical complaints. One of the

  16. Comparing cluster-level dynamic treatment regimens using sequential, multiple assignment, randomized trials: Regression estimation and sample size considerations.

    Science.gov (United States)

    NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

    2017-08-01

    Cluster-level dynamic treatment regimens can be used to guide sequential treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level dynamic treatment regimen, the treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including aggregate measures of the individuals or patients that compose it. Cluster-randomized sequential multiple assignment randomized trials can be used to answer multiple open questions preventing scientists from developing high-quality cluster-level dynamic treatment regimens. In a cluster-randomized sequential multiple assignment randomized trial, sequential randomizations occur at the cluster level and outcomes are observed at the individual level. This manuscript makes two contributions to the design and analysis of cluster-randomized sequential multiple assignment randomized trials. First, a weighted least squares regression approach is proposed for comparing the mean of a patient-level outcome between the cluster-level dynamic treatment regimens embedded in a sequential multiple assignment randomized trial. The regression approach facilitates the use of baseline covariates which is often critical in the analysis of cluster-level trials. Second, sample size calculators are derived for two common cluster-randomized sequential multiple assignment randomized trial designs for use when the primary aim is a between-dynamic treatment regimen comparison of the mean of a continuous patient-level outcome. The methods are motivated by the Adaptive Implementation of Effective Programs Trial which is, to our knowledge, the first-ever cluster-randomized sequential multiple assignment randomized trial in psychiatry.

  17. Causal Effects of Single-Sex Schools on College Entrance Exams and College Attendance: Random Assignment in Seoul High Schools

    OpenAIRE

    Park, Hyunjoon; Behrman, Jere R.; Choi, Jaesung

    2013-01-01

    Despite the voluminous literature on the potentials of single-sex schools, there is no consensus on the effects of single-sex schools because of student selection of school types. We exploit a unique feature of schooling in Seoul—the random assignment of students into single-sex versus coeducational high schools—to assess causal effects of single-sex schools on college entrance exam scores and college attendance. Our validation of the random assignment shows comparable socioeconomic backgroun...

  18. Perturbation Solutions for Random Linear Structural Systems subject to Random Excitation using Stochastic Differential Equations

    DEFF Research Database (Denmark)

    Köyluoglu, H.U.; Nielsen, Søren R.K.; Cakmak, A.S.

    1994-01-01

    The paper deals with the first and second order statistical moments of the response of linear systems with random parameters subject to random excitation modelled as white-noise multiplied by an envelope function with random parameters. The method of analysis is basically a second order perturbat......The paper deals with the first and second order statistical moments of the response of linear systems with random parameters subject to random excitation modelled as white-noise multiplied by an envelope function with random parameters. The method of analysis is basically a second order...... for multi-degree-of-freedom (MDOF) systems and the method is illustrated for a single-degree-of-freedom (SDOF) oscillator. The results are compared to those of exact results for a random oscillator subject to white noise excitation with random intensity....

  19. On the Possibility of Assigning Probabilities to Singular Cases, or: Probability Is Subjective Too!

    Directory of Open Access Journals (Sweden)

    Mark R. Crovelli

    2009-06-01

    Full Text Available Both Ludwig von Mises and Richard von Mises claimed that numerical probability could not be legitimately applied to singular cases. This paper challenges this aspect of the von Mises brothers’ theory of probability. It is argued that their denial that numerical probability could be applied to singular cases was based solely upon Richard von Mises’ exceptionally restrictive definition of probability. This paper challenges Richard von Mises’ definition of probability by arguing that the definition of probability necessarily depends upon whether the world is governed by time-invariant causal laws. It is argued that if the world is governed by time-invariant causal laws, a subjective definition of probability must be adopted. It is further argued that both the nature of human action and the relative frequency method for calculating numerical probabilities both presuppose that the world is indeed governed by time-invariant causal laws. It is finally argued that the subjective definition of probability undercuts the von Mises claim that numerical probability cannot legitimately be applied to singular, non-replicable cases.

  20. Subjective and objective outcomes in randomized clinical trials

    DEFF Research Database (Denmark)

    Moustgaard, Helene; Bello, Segun; Miller, Franklin G

    2014-01-01

    OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...... provided for subjective outcome: (1) dependent on assessor judgment, (2) patient-reported outcome, or (3) private phenomena (ie, phenomena only assessable by the patient). Of the 200 clinical trial reports, 12 used the term "subjective" and/or "objective" about outcomes, but no clinical trial reports...

  1. Solution Methods for Structures with Random Properties Subject to Random Excitation

    DEFF Research Database (Denmark)

    Köylüoglu, H. U.; Nielsen, Søren R. K.; Cakmak, A. S.

    This paper deals with the lower order statistical moments of the response of structures with random stiffness and random damping properties subject to random excitation. The arising stochastic differential equations (SDE) with random coefficients are solved by two methods, a second order...... perturbation approach and a Markovian method. The second order perturbation approach is grounded on the total probability theorem and can be compactly written. Moreover, the problem to be solved is independent of the dimension of the random variables involved. The Markovian approach suggests transforming...... the SDE with random coefficients with deterministic initial conditions to an equivalent nonlinear SDE with deterministic coefficient and random initial conditions. In both methods, the statistical moment equations are used. Hierarchy of statistical moments in the markovian approach is closed...

  2. Quality of pharmacy-specific Medical Subject Headings (MeSH) assignment in pharmacy journals indexed in MEDLINE.

    Science.gov (United States)

    Minguet, Fernando; Salgado, Teresa M; van den Boogerd, Lucienne; Fernandez-Llimos, Fernando

    2015-01-01

    The Medical Subject Headings (MeSH) is the National Library of Medicine (NLM) controlled vocabulary for indexing articles. Inaccuracies in the MeSH thesaurus have been reported for several areas including pharmacy. To assess the quality of pharmacy-specific MeSH assignment to articles indexed in pharmacy journals. The 10 journals containing the highest number of articles published in 2012 indexed under the MeSH 'Pharmacists' were identified. All articles published over a 5-year period (2008-2012) in the 10 previously selected journals were retrieved from PubMed. MeSH terms used to index these articles were extracted and pharmacy-specific MeSH terms were identified. The frequency of use of pharmacy-specific MeSH terms was calculated across journals. A total of 6989 articles were retrieved from the 10 pharmacy journals, of which 328 (4.7%) were articles not fully indexed and therefore did not contain any MeSH terms assigned. Among the 6661 articles fully indexed, the mean number of MeSH terms was 10.1 (SD = 4.0), being 1.0 (SD = 1.3) considered as Major MeSH. Both values significantly varied across journals. The mean number of pharmacy-specific MeSH terms per article was 0.9 (SD = 1.2). A total of 3490 (52.4%) of the 6661 articles were indexed in pharmacy journals without a single pharmacy-specific MeSH. Of the total 67193 MeSH terms assigned to articles, on average 10.5% (SD = 13.9) were pharmacy-specific MeSH. A statistically significant different pattern of pharmacy-specific MeSH assignment was identified across journals (Kruskal-Wallis P MeSH terms to articles indexed in pharmacy journals can be improved to further enhance evidence gathering in pharmacy. Over half of the articles published in the top-10 journals publishing pharmacy literature were indexed without a single pharmacy-specific MeSH. Copyright © 2015 Elsevier Inc. All rights reserved.

  3. Random Assignment of Schools to Groups in the Drug Resistance Strategies Rural Project: Some New Methodological Twists

    Science.gov (United States)

    Pettigrew, Jonathan; Miller-Day, Michelle; Krieger, Janice L.; Zhou, Jiangxiu; Hecht, Michael L.

    2014-01-01

    Random assignment to groups is the foundation for scientifically rigorous clinical trials. But assignment is challenging in group randomized trials when only a few units (schools) are assigned to each condition. In the DRSR project, we assigned 39 rural Pennsylvania and Ohio schools to three conditions (rural, classic, control). But even with 13 schools per condition, achieving pretest equivalence on important variables is not guaranteed. We collected data on six important school-level variables: rurality, number of grades in the school, enrollment per grade, percent white, percent receiving free/assisted lunch, and test scores. Key to our procedure was the inclusion of school-level drug use data, available for a subset of the schools. Also, key was that we handled the partial data with modern missing data techniques. We chose to create one composite stratifying variable based on the seven school-level variables available. Principal components analysis with the seven variables yielded two factors, which were averaged to form the composite inflate-suppress (CIS) score which was the basis of stratification. The CIS score was broken into three strata within each state; schools were assigned at random to the three program conditions from within each stratum, within each state. Results showed that program group membership was unrelated to the CIS score, the two factors making up the CIS score, and the seven items making up the factors. Program group membership was not significantly related to pretest measures of drug use (alcohol, cigarettes, marijuana, chewing tobacco; smallest p>.15), thus verifying that pretest equivalence was achieved. PMID:23722619

  4. It Takes Two Shining Lights to Brighten the Room: Peer Effects with Random Roommate Assignments

    Science.gov (United States)

    Zhang, Liang; Pu, Shi

    2017-01-01

    We used housing assignment data from a college in China to investigate peer effects on college grades. Study results provided some evidence for peer effects in college housing units. First, peer effects through means occurred during both fall and spring semester of the first year in college, with estimated effect much larger than that in previous…

  5. An assessment of health behavior peer effects in Peking University dormitories: a randomized cluster-assignment design for interference.

    Science.gov (United States)

    Yuan, Changzheng; Lv, Jun; VanderWeele, Tyler J

    2013-01-01

    Relatively little is known about the peer influence in health behaviors within university dormitory rooms. Moreover, in China, the problem of unhealthy behaviors among university students has not yet been sufficiently recognized. We thus investigated health behavior peer influence in Peking University dormitories utilizing a randomized cluster-assignment design. Cross-sectional in-dormitory survey. Current students from Peking University Health Science Center from April to June, 2009. Self-reported questionnaire on health behaviors: physical activity (including bicycling), dietary intake and tobacco use. Use of bicycle, moderate-intensity exercise, frequency of sweet food and soybean milk intake, frequency of roasted/baked/toasted food intake were behaviors significantly or marginally significantly affected by peer influence. Health behavior peer effects exist within dormitory rooms among university students. This could provide guidance on room assignment, or inform intervention programs. Examining these may demand attention from university administrators and policy makers.

  6. Causal effects of single-sex schools on college entrance exams and college attendance: random assignment in Seoul high schools.

    Science.gov (United States)

    Park, Hyunjoon; Behrman, Jere R; Choi, Jaesung

    2013-04-01

    Despite the voluminous literature on the potentials of single-sex schools, there is no consensus on the effects of single-sex schools because of student selection of school types. We exploit a unique feature of schooling in Seoul-the random assignment of students into single-sex versus coeducational high schools-to assess causal effects of single-sex schools on college entrance exam scores and college attendance. Our validation of the random assignment shows comparable socioeconomic backgrounds and prior academic achievement of students attending single-sex schools and coeducational schools, which increases the credibility of our causal estimates of single-sex school effects. The three-level hierarchical model shows that attending all-boys schools or all-girls schools, rather than coeducational schools, is significantly associated with higher average scores on Korean and English test scores. Applying the school district fixed-effects models, we find that single-sex schools produce a higher percentage of graduates who attended four-year colleges and a lower percentage of graduates who attended two-year junior colleges than do coeducational schools. The positive effects of single-sex schools remain substantial, even after we take into account various school-level variables, such as teacher quality, the student-teacher ratio, the proportion of students receiving lunch support, and whether the schools are public or private.

  7. Causal Effects of Single-Sex Schools on College Entrance Exams and College Attendance: Random Assignment in Seoul High Schools

    Science.gov (United States)

    Park, Hyunjoon; Behrman, Jere R.; Choi, Jaesung

    2012-01-01

    Despite the voluminous literature on the potentials of single-sex schools, there is no consensus on the effects of single-sex schools because of student selection of school types. We exploit a unique feature of schooling in Seoul—the random assignment of students into single-sex versus coeducational high schools—to assess causal effects of single-sex schools on college entrance exam scores and college attendance. Our validation of the random assignment shows comparable socioeconomic backgrounds and prior academic achievement of students attending single-sex schools and coeducational schools, which increases the credibility of our causal estimates of single-sex school effects. The three-level hierarchical model shows that attending all-boys schools or all-girls schools, rather than coeducational schools, is significantly associated with higher average scores on Korean and English test scores. Applying the school district fixed-effects models, we find that single-sex schools produce a higher percentage of graduates who attended four-year colleges and a lower percentage of graduates who attended two-year junior colleges than do coeducational schools. The positive effects of single-sex schools remain substantial, even after we take into account various school-level variables, such as teacher quality, the student-teacher ratio, the proportion of students receiving lunch support, and whether the schools are public or private. PMID:23073751

  8. Communication interventions for minimally verbal children with autism: a sequential multiple assignment randomized trial.

    Science.gov (United States)

    Kasari, Connie; Kaiser, Ann; Goods, Kelly; Nietfeld, Jennifer; Mathy, Pamela; Landa, Rebecca; Murphy, Susan; Almirall, Daniel

    2014-06-01

    This study tested the effect of beginning treatment with a speech-generating device (SGD) in the context of a blended, adaptive treatment design for improving spontaneous, communicative utterances in school-aged, minimally verbal children with autism. A total of 61 minimally verbal children with autism, aged 5 to 8 years, were randomized to a blended developmental/behavioral intervention (JASP+EMT) with or without the augmentation of a SGD for 6 months with a 3-month follow-up. The intervention consisted of 2 stages. In stage 1, all children received 2 sessions per week for 3 months. Stage 2 intervention was adapted (by increased sessions or adding the SGD) based on the child's early response. The primary outcome was the total number of spontaneous communicative utterances; secondary measures were the total number of novel words and total comments from a natural language sample. Primary aim results found improvements in spontaneous communicative utterances, novel words, and comments that all favored the blended behavioral intervention that began by including an SGD (JASP+EMT+SGD) as opposed to spoken words alone (JASP+EMT). Secondary aim results suggest that the adaptive intervention beginning with JASP+EMT+SGD and intensifying JASP+EMT+SGD for children who were slow responders led to better posttreatment outcomes. Minimally verbal school-aged children can make significant and rapid gains in spoken spontaneous language with a novel, blended intervention that focuses on joint engagement and play skills and incorporates an SGD. Future studies should further explore the tailoring design used in this study to better understand children's response to treatment. Clinical trial registration information-Developmental and Augmented Intervention for Facilitating Expressive Language (CCNIA); http://clinicaltrials.gov/; NCT01013545. Copyright © 2014 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

  9. Communication Interventions for Minimally Verbal Children With Autism: Sequential Multiple Assignment Randomized Trial

    Science.gov (United States)

    Kasari, Connie; Kaiser, Ann; Goods, Kelly; Nietfeld, Jennifer; Mathy, Pamela; Landa, Rebecca; Murphy, Susan; Almirall, Daniel

    2014-01-01

    Objective This study tested the effect of beginning treatment with a speech-generating device in the context of a blended, adaptive treatment design for improving spontaneous, communicative utterances in school-aged, minimally verbal children with autism. Method Sixty-one minimally verbal children with autism, aged 5 to 8 years, were randomized to a blended developmental/behavioral intervention (JASP+EMT) with or without the augmentation of a speech-generating device (SGD) for 6 months with a 3-month follow-up. The intervention consisted of two stages. In Stage 1 all children received two sessions per week for 3 months. Stage 2 intervention was adapted (increased sessions or adding the SGD) based on the child’s early response. The primary outcome was the total number of spontaneous communicative utterances; secondary measures were total number of novel words and total comments from a natural language sample. Results Primary aim results found improvements in spontaneous communicative utterances, novel words, and comments that all favored the blended behavioral intervention that began by including an SGD (JASP+EMT+SGD) as opposed to spoken words alone (JASP+EMT). Secondary aim results suggest that the adaptive intervention beginning with JASP+EMT+SGD and intensifying JASP+EMT+SGD for children who were slow responders led to better post-treatment outcomes. Conclusion Minimally verbal school-aged children can make significant and rapid gains in spoken spontaneous language with a novel, blended intervention that focuses on joint engagement and play skills and incorporates an SGD. Future studies should further explore the tailoring design used in this study to better understand children’s response to treatment. Clinical trial registration information—Developmental and Augmented Intervention for Facilitating Expressive Language (CCNIA); http://clinicaltrials.gov/; NCT01013545. PMID:24839882

  10. Notes and shorter communications; the assignment of subjects to disease prone personality types : a comment on Schmitz

    NARCIS (Netherlands)

    Ranchor, A.V.; Sanderman, R.; Bouma, J

    1993-01-01

    In this paper the assignment procedure is discussed which has been used in the study of Schmitz (1992; Personality and Individual Differences, 13, 683-691) investigating the relation between the personality types of Grossarth-Maticek and Eysenck and various physical complaints. One of the

  11. Comparisons of node-based and element-based approaches of assigning bone material properties onto subject-specific finite element models.

    Science.gov (United States)

    Chen, G; Wu, F Y; Liu, Z C; Yang, K; Cui, F

    2015-08-01

    Subject-specific finite element (FE) models can be generated from computed tomography (CT) datasets of a bone. A key step is assigning material properties automatically onto finite element models, which remains a great challenge. This paper proposes a node-based assignment approach and also compares it with the element-based approach in the literature. Both approaches were implemented using ABAQUS. The assignment procedure is divided into two steps: generating the data file of the image intensity of a bone in a MATLAB program and reading the data file into ABAQUS via user subroutines. The node-based approach assigns the material properties to each node of the finite element mesh, while the element-based approach assigns the material properties directly to each integration point of an element. Both approaches are independent from the type of elements. A number of FE meshes are tested and both give accurate solutions; comparatively the node-based approach involves less programming effort. The node-based approach is also independent from the type of analyses; it has been tested on the nonlinear analysis of a Sawbone femur. The node-based approach substantially improves the level of automation of the assignment procedure of bone material properties. It is the simplest and most powerful approach that is applicable to many types of analyses and elements. Copyright © 2015 IPEM. Published by Elsevier Ltd. All rights reserved.

  12. Peer Influence on Aggressive Behavior, Smoking, and Sexual Behavior: A Study of Randomly-assigned College Roommates.

    Science.gov (United States)

    Li, Yi; Guo, Guang

    2016-09-01

    Identifying casual peer influence is a long-standing challenge to social scientists. Using data from a natural experiment of randomly-assigned college roommates (N = 2,059), which removes the threat of friend selection, we investigate peer effects on aggressive behavior, smoking, and concurrent sexual partnering. The findings suggest that the magnitude and direction of peer influence depend on predisposition, gender, and the nature of the behavior. Peer effects on individuals predisposed toward a given behavior tend to be larger than peer effects on individuals without such a predisposition. We find that the influence of roommates on aggressive behavior is more pronounced among male students than among female students; roommate effects on smoking are negative among female students and male students who did not smoke before college. For concurrent sexual partnering, a highly private behavior, we find no evidence of peer effects. © American Sociological Association 2016.

  13. Separating boys and girls and increasing weight? Assessing the impacts of single-sex schools through random assignment in Seoul.

    Science.gov (United States)

    Choi, Jaesung; Park, Hyunjoon; Behrman, Jere R

    2015-06-01

    A growing body of research reports associations of school contexts with adolescents' weight and weight-related behaviors. One interesting, but under-researched, dimension of school context that potentially matters for adolescents' weight is the gender composition. If boys and girls are separated into single-sex schools, they might be less concerned about physical appearance, which may result in increased weight. Utilizing a unique setting in Seoul, Korea where students are randomly assigned to single-sex and coeducational schools within school districts, we estimate causal effects of single-sex schools on weight and weight-related behaviors. Our results show that students attending single-sex schools are more likely to be overweight, and that the effects are more pronounced for girls. We also find that girls in single-sex schools are less likely to engage in strenuous activities than their coeducational counterparts. Copyright © 2015 Elsevier Ltd. All rights reserved.

  14. Random search for shared chromosomal regions in four affected individuals: the assignment of a new hereditary ataxia locus

    Energy Technology Data Exchange (ETDEWEB)

    Nikali, K.; Suomalainen, A.; Koskinen, T.; Peltonen, L. [Univ. of Helsinki (Finland); Terwilliger, J. [Univ. of Oxford (United Kingdom); Weissenbach, J. [Genethon, Evry (France)

    1995-05-01

    Infantile-onset spinocerebellar ataxia (IOSCA) is an autosomal recessively inherited progressive neurological disorder of unknown etiology. This ataxia, identified so far only in the genetically isolated Finnish population, does not share gene locus with any of the previously identified hereditary ataxias, and a random mapping approach was adopted to assign the IOSCA locus. Based on the assumption of one founder mutation, a primary screening of the genome was performed using samples from just four affected individuals in two consanguineous pedigrees. The identification of a shared chromosomal region in these four patients provided the first evidence that the IOSCA gene locus is on chromosome 10q23.3-q24.1, which was confirmed by conventional linkage analysis in the complete family material. Strong linkage disequilibrium observed between IOSCA and the linked markers was utilized to define accurately the critical chromosomal region. The results showed the power of linkage disequilibrium in the locus assignment of diseases with very limited family materials. 30 refs., 3 figs., 2 tabs.

  15. An assessment of health behavior peer effects in Peking University dormitories: a randomized cluster-assignment design for interference.

    Directory of Open Access Journals (Sweden)

    Changzheng Yuan

    Full Text Available BACKGROUND: Relatively little is known about the peer influence in health behaviors within university dormitory rooms. Moreover, in China, the problem of unhealthy behaviors among university students has not yet been sufficiently recognized. We thus investigated health behavior peer influence in Peking University dormitories utilizing a randomized cluster-assignment design. METHODS: STUDY DESIGN: Cross-sectional in-dormitory survey. STUDY POPULATION: Current students from Peking University Health Science Center from April to June, 2009. MEASUREMENT: Self-reported questionnaire on health behaviors: physical activity (including bicycling, dietary intake and tobacco use. RESULTS: Use of bicycle, moderate-intensity exercise, frequency of sweet food and soybean milk intake, frequency of roasted/baked/toasted food intake were behaviors significantly or marginally significantly affected by peer influence. CONCLUSION: Health behavior peer effects exist within dormitory rooms among university students. This could provide guidance on room assignment, or inform intervention programs. Examining these may demand attention from university administrators and policy makers.

  16. Robustness of parameter and standard error estimates against ignoring a contextual effect of a subject level covariate in cluster randomized trials

    NARCIS (Netherlands)

    Korendijk, E.J.H.; Hox, J.; Moerbeek, M.

    2011-01-01

    In experimental research, it is not uncommon to assign clusters to conditions.When analysing the data of such cluster-randomized trials, a multilevel analysis should be applied in order to take into account the dependency of firstlevel units (i.e., subjects) within a second-level unit (i.e., a

  17. A better alternative to stratified permuted block design for subject randomization in clinical trials.

    Science.gov (United States)

    Zhao, Wenle

    2014-12-30

    Stratified permuted block randomization has been the dominant covariate-adaptive randomization procedure in clinical trials for several decades. Its high probability of deterministic assignment and low capacity of covariate balancing have been well recognized. The popularity of this sub-optimal method is largely due to its simplicity in implementation and the lack of better alternatives. Proposed in this paper is a two-stage covariate-adaptive randomization procedure that uses the block urn design or the big stick design in stage one to restrict the treatment imbalance within each covariate stratum, and uses the biased-coin minimization method in stage two to control imbalances in the distribution of additional covariates that are not included in the stratification algorithm. Analytical and simulation results show that the new randomization procedure significantly reduces the probability of deterministic assignments, and improve the covariate balancing capacity when compared to the traditional stratified permuted block randomization. Copyright © 2014 John Wiley & Sons, Ltd.

  18. Teaching reading to children with neurofibromatosis type 1: a clinical trial with random assignment to different approaches.

    Science.gov (United States)

    Barquero, Laura A; Sefcik, Angela M; Cutting, Laurie E; Rimrodt, Sheryl L

    2015-12-01

    Neurofibromatosis type 1 (NF1) is a genetic disorder with a cognitive profile that includes visual-spatial perception deficits and a high incidence of reading disability. There is a paucity of information about how this cognitively complex population responds to mainstream reading interventions. The clinical trial goals were to determine whether children and adolescents with NF1 and reading deficits (NF+RD) benefit from mainstream remedial reading programs and whether responsiveness varies with differences in program-related visual-spatial demands. Forty-nine participants (28 males, 21 females; aged 8-14y) with either NF+RD (n=17, 11 males, six females) or idiopathic reading deficit (IRD) (n=32, 17 males, 15 females) were randomly assigned to intensive remedial teaching using one of two multisensory reading programs: one with greater kinesthetic demands and the other with greater visual-spatial demands. Two control groups - wait-list IRD (n=14, 11 males, three females) and typically developing readers (n=26, 13 males, 13 females) - received no treatment. Repeated measures and multivariate ANOVA analyses compared each group's growth in reading achievement from pre- to post-testing. Treated groups showed significant growth whereas untreated groups did not. Comparing treated groups, the IRD group responded equally well to both interventions, whereas the NF+RD group showed a better response to the more kinesthetic approach. Results suggest that multisensory remedial reading teaching that emphasizes kinesthetic demands more than visual-spatial demands is suitable for students with NF+RD. © 2015 Mac Keith Press.

  19. Peripheral Defocus and Myopia Progression in Myopic Children Randomly Assigned to Wear Single Vision and Progressive Addition Lenses

    Science.gov (United States)

    Berntsen, David A.; Barr, Christopher D.; Mutti, Donald O.; Zadnik, Karla

    2013-01-01

    Purpose. To determine the effect of progressive addition lenses (PALs) and single vision lenses (SVLs) on peripheral defocus in myopic children, and to compare the effect of myopic versus hyperopic peripheral defocus on foveal myopia progression. Methods. Eighty-four myopic children aged 6 to 11 years with spherical equivalent (SE) cycloplegic autorefraction between −0.75 diopters (D) and −4.50 D were randomly assigned to wear SVLs or PALs. Aberrometry measurements of the eye and spectacles were made centrally, 30° nasally, temporally, and superiorly, and 20° inferiorly on the retina using a Complete Ophthalmic Analysis System for Vision Research (COAS-VR). The association between peripheral defocus and the 1-year change in central myopia was investigated. Results. SVLs caused a hyperopic shift in peripheral defocus at all locations (all P ≤ 0.0003). PALs caused a myopic shift in peripheral defocus in three of four locations measured (all P ≤ 0.01) with the greatest shift superiorly due to the PAL addition (−1.04 ± 0.30 D). Superior retinal defocus when wearing either SVLs or PALs was associated with the 1-year change in central myopia. The adjusted 1-year change in central SE myopia was −0.38 D for children with absolute superior myopic defocus (n = 67) and −0.65 D for children with absolute superior hyperopic defocus (n = 17; difference = 0.27 D; P = 0.002). Conclusions. PALs caused a myopic shift in peripheral defocus. Superior myopic defocus was associated with less central myopia progression. These data support the continued investigation of optical designs that result in peripheral myopic defocus as a potential way to slow myopia progression. (ClinicalTrials.gov number, NCT00335049.) PMID:23838771

  20. The Effects of Therapist Competence in Assigning Homework in Cognitive Therapy with Cluster C Personality Disorders: Results from a Randomized Controlled Trial

    Science.gov (United States)

    Ryum, Truls; Stiles, Tore C.; Svartberg, Martin; McCullough, Leigh

    2010-01-01

    Therapist competence in assigning homework was used to predict mid- and posttreatment outcome for patients with Cluster C personality disorders in cognitive therapy (CT). Twenty-five patients that underwent 40 sessions of CT were taken from a randomized controlled trial (Svartberg, Stiles, & Seltzer, 2004). Therapist competence in assigning…

  1. Efficacy of Visual-Acoustic Biofeedback Intervention for Residual Rhotic Errors: A Single-Subject Randomization Study.

    Science.gov (United States)

    McAllister Byun, Tara

    2017-05-24

    This study documented the efficacy of visual-acoustic biofeedback intervention for residual rhotic errors, relative to a comparison condition involving traditional articulatory treatment. All participants received both treatments in a single-subject experimental design featuring alternating treatments with blocked randomization of sessions to treatment conditions. Seven child and adolescent participants received 20 half-hour sessions of individual treatment over 10 weeks. Within each week, sessions were randomly assigned to feature traditional or biofeedback intervention. Perceptual accuracy of rhotic production was assessed in a blinded, randomized fashion. Each participant's response to the combined treatment package was evaluated by using effect sizes and visual inspection. Differences in the magnitude of response to traditional versus biofeedback intervention were measured with individual randomization tests. Four of 7 participants demonstrated a clinically meaningful response to the combined treatment package. Three of 7 participants showed a statistically significant difference between treatment conditions. In all 3 cases, the magnitude of within-session gains associated with biofeedback exceeded the gains associated with traditional treatment. These results suggest that the inclusion of visual-acoustic biofeedback can enhance the efficacy of intervention for some individuals with residual rhotic errors. Further research is needed to understand which participants represent better or poorer candidates for biofeedback treatment.

  2. Demonstrating treatment efficacy using the single subject randomization design: A tutorial and demonstration.

    Science.gov (United States)

    Rvachew, Susan; Matthews, Tanya

    2017-05-01

    Single case research refers to the broader category of research designs in which each case serves as his or her own control. A single subject randomization design is a specific form in which sessions are randomly allocated to treatment conditions within subjects. Two tutorials on the application of these designs are provided. In the single subject randomized phase design, baseline probes are administered repeatedly during a no-treatment or usual care phase; subsequently probes are administered repeatedly during the treatment phase of the experiment; the starting point for the treatment phase is determined by random selection. In the single subject randomized alternation design, any session can be randomly allocated to any treatment condition. In either case, the test statistic can be the mean of probe performance during the treatment sessions after subtracting the baseline mean. The significance of the obtained test statistic is determined by resampling test. Specifically, the obtained test statistic is interpreted relative to a distribution of test statistics generated by all possible random allocations. This distribution yields a P value which represents the probability of obtaining a test statistic as large as that obtained by the selected allocation. In addition to the tutorials, two experiments using these designs with a single 8-year-old participant with Childhood Apraxia of Speech are presented to demonstrate the utility of these designs and the application of the associated statistical analysis procedures. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. Consuming a mixed diet enriched with lupin protein beneficially affects plasma lipids in hypercholesterolemic subjects: a randomized controlled trial.

    Science.gov (United States)

    Bähr, Melanie; Fechner, Anita; Kiehntopf, Michael; Jahreis, Gerhard

    2015-02-01

    The objectives of this study were to assess whether 25 g/d lupin protein, integrated into a mixed diet, might affect cardiovascular risk factors and whether l-arginine was responsible for these effects. Seventy-two hypercholesterolemic subjects participated in the randomized, controlled, double-blind three-phase crossover study. They were assigned to three diets with 25 g/d lupin protein (LP), milk protein (MP) or milk protein plus 1.6 g/d arginine (MPA) each for 28 d in a random order interrupted by 6-week washout periods. Lupin protein and the comparator milk protein were incorporated into complex food products (bread, roll, sausage, and vegetarian spread). Arginine was administered via capsules. Sixty-eight subjects were included in final analyses. Compared with MP, LDL cholesterol was significantly lower after LP. Compared with MP and MPA, homocysteine was significantly lower after LP. Compared with baseline, concentrations of total, LDL, and HDL cholesterol significantly decreased after LP and MPA. Triacylglycerols and uric acid significantly decreased after LP. The relative changes in total and LDL cholesterol were significantly greater for subjects with severe hypercholesterolemia (>6.6 mmol/L) than those with moderate hypercholesterolemia (5.2-6.6 mmol/L). The present study showed for the first time that incorporation of 25 g/d of lupin protein into a variety of complex food products lowers total and LDL cholesterol, triacylglycerols, homocysteine, and uric acid in hypercholesterolemic subjects. The hypocholesterolemic effect is stronger in subjects with severe hypercholesterolemia. Arginine might be responsible for some, but not all of the beneficial effects of lupin protein. This trial was registered at http://clinicaltrials.gov (study ID number NCT01598649). Copyright © 2014 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  4. Changes in depression status in low socioeconomic perinatal subjects in rural India after supervised physical exercise: A randomized controlled study

    Science.gov (United States)

    Bose, Gopal Nambi Subash Chandra

    2015-01-01

    Background: Perinatal depression is a major public health problem, affecting up to a quarter of all pregnant women in rural Asean countries and often leads to psychologic symptoms, lower quality of life, and higher health care costs. The purpose of this study was to assess the impact of supervised physical exercise on depression level of perinatal subjects. Subjects/Intervention: 60 subjects who fulfill the selection criteria were randomly assigned to exercise (Group-1, n=30) and control group (Group-2, n=30). Participants completed general screening form and Physical health questionnaire-9 (PHQ-9) before their intervention and again 4 weeks and 8 weeks later. Group-1 underwent aerobic training with 60-65% maximum heart rate and Group-2 was prescribed with handouts for 4 weeks. Statistics: Repeated-measures analysis of variance (ANOVA) was use to analyze group differences over time while controlling for baseline differences. Results: Demographic and the baseline values show homogenous population (P>0.05). Patients in both groups experienced significant reduction in depression level. Group A showed reduction of 91.70% (P=0.00) as compared to Group B 69.01% (P=0.00). Conclusion: These results suggest that supervised physical exercise provides better improvement in depression status in perinatal subjects than providing handouts alone. PMID:26816432

  5. Assignment refusal and its relation to outcome in a randomized controlled trial comparing Cognitive Therapy and Fluvoxamine in treatment-resistant patients with obsessive compulsive disorder.

    Science.gov (United States)

    Landsheer, Johannes A; Smit, Johannes H; van Oppen, Patricia; van Balkom, Anton J L M

    2015-03-30

    The effectiveness of Fluvoxamine was compared to that of Cognitive Therapy (CT) in a 12-week randomized controlled trial (RCT) in 48 patients with obsessive-compulsive disorder (OCD), who were treatment-resistant to a previous behavior therapy (BT). A considerable amount of patients did not comply with the assigned treatment and switched treatments. The aim of this study was to identify patient characteristics predictive of assignment compliance and to study whether these characteristics were related to outcome. A logistic model, based on psychological and social patient characteristics, in addition to or in interaction with the assignment, was used for the explanation of compliance with treatment assignment. Especially patients who have a higher score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) tend to comply with the effective Fluvoxamine treatment. The same set of variables was related to both compliance and outcome of therapy received. Therefore, the logistic model of compliance could be used to reduce the positive bias of As-Treated analysis (AT). The difference between the results of Fluvoxamine and Cognitive Therapy remained statistically significant after correcting for the positive bias as the result of assignment refusal and after applying the assumption that two drop-out patients needed imputation of lesser results. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  6. The effects of three different exercise modalities on markers of male reproduction in healthy subjects: a randomized controlled trial.

    Science.gov (United States)

    Hajizadeh Maleki, Behzad; Tartibian, Bakhtyar; Chehrazi, Mohammad

    2017-02-01

    The aim of this study was to investigate the effects of moderate-intensity continuous training (MICT), high-intensity continuous training (HICT) and high-intensity interval training (HIIT) on markers of male reproduction including seminal markers of oxidative stress and inflammation as well as semen quality and sperm DNA integrity in healthy human subjects. A total of 397 healthy male volunteers were screened and 280 were randomly assigned to one of the MICT (n = 70), HICT (n = 70), HIIT (n = 70) and non-exercise (NON-EX, n = 70) groups. Subjects had inflammatory markers (IL-1β, IL-6, IL-8 and TNF-α), oxidants (ROS, MDA and 8-isoprostane), antioxidants (SOD, catalase and TAC), semen parameters and sperm DNA damage measured at baseline (T1), the end of week 12 (T2), the end of week 24 (T3), and 7 (T4) and 30 days (T5) after training. Chronic MICT, HICT and HIIT attenuated seminal markers of oxidative stress and inflammation with different kinetics for the three types of exercise (P reproductive function (P reproduction with different kinetics, suggesting intensity-, duration- and type-dependent adaptations to exercise training in healthy human subjects. © 2017 Society for Reproduction and Fertility.

  7. Effect of fish oil on cognitive performance in older subjects: a randomized, controlled trial

    NARCIS (Netherlands)

    van de Rest, O.; Geleijnse, J.M.; Kok, F. J.; van Staveren, W.A.; Dullemeijer, C.; Olde Rikkert, M.G.M.; Beekman, A.T.F.; de Groot, C.P.

    2008-01-01

    Background: High intake of n-3 polyunsaturated fatty acids may protect against age-related cognitive decline. However, results from epidemiologic studies are inconclusive, and results from randomized trials in elderly subjects without dementia are lacking. Objective: To investigate the effect of

  8. Effect of fish oil on cognitive performance in older subjects: a randomized, controlled trial.

    NARCIS (Netherlands)

    Rest, O van de; Geleijnse, J.M.; Kok, F.J.; Staveren, W.A. van; Dullemeijer, C.; Olderikkert, M.G.; Beekman, A.T.; Groot, CP de

    2008-01-01

    BACKGROUND: High intake of n-3 polyunsaturated fatty acids may protect against age-related cognitive decline. However, results from epidemiologic studies are inconclusive, and results from randomized trials in elderly subjects without dementia are lacking. OBJECTIVE: To investigate the effect of

  9. [The request for consent in clinical research: a randomized study in healthy subjects].

    Science.gov (United States)

    Perrone, F; De Placido, S; Giusti, C; Gallo, C

    1995-09-01

    To compare two strategies of consent requirement (classical informed consent and randomised consent according to Zelen), the Clinical Data Elaboration Centre of South Italy, within the special project Clinical Application of Oncological Research of the National Research Council of Italy (CNR-ACRO) invited healthy people visiting the 7th edition of the scientific exhibition "Futuro Remoto" to simulate of being ill and receiving the offer of entering a clinical trial. Within informed consent strategy patients are asked to agree to the randomisation process, while, in the randomised consent, randomised treatment assignment is performed before consent requirement and patients should agree directly to the assigned therapy. Major aims of the study were (a) to compare the strategies in terms of refusal rate to a hypothetical clinical trial, and (b) to estimate whether severity of prognosis affected subjects' decision. 3,217 visiting people participated to the simulation; they were prevalently young, males and with a high level of school education. The study was performed in two different scenarios. In the first one, with one choice option, subject refusing consent could receive standard therapy only; refusal rate was 16% after informed consent and 13.4% after randomised consent (for experimental therapy). In the other scenario, with two choice options, subjects refusing consent could choose the preferred therapy; refusal rate was 20.6% after informed consent, 48.1% after randomised consent (for standard therapy) and 13.4% after randomised consent (for experimental therapy).(ABSTRACT TRUNCATED AT 250 WORDS)

  10. Soft-assignment random-forest with an application to discriminative representation of human actions in videos

    NARCIS (Netherlands)

    Burghouts, G.J.

    2013-01-01

    The bag-of-features model is a distinctive and robust approach to detect human actions in videos. The discriminative power of this model relies heavily on the quantization of the video features into visual words. The quantization determines how well the visual words describe the human action. Random

  11. Comparing cluster-level dynamic treatment regimens using sequential, multiple assignment, randomized trials: Regression estimation and sample size considerations

    OpenAIRE

    NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

    2016-01-01

    Cluster-level dynamic treatment regimens can be used to guide sequential, intervention or treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level DTR, the intervention or treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including based on aggregate measures of the individuals or patients that comprise it. Cluster-randomized sequentia...

  12. Subjectivity

    Directory of Open Access Journals (Sweden)

    Jesús Vega Encabo

    2015-11-01

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

  13. Who is the research subject in cluster randomized trials in health research?

    Directory of Open Access Journals (Sweden)

    Brehaut Jamie C

    2011-07-01

    Full Text Available Abstract This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation. This paper addresses the first of the questions posed, namely, who is the research subject in a CRT in health research? The identification of human research subjects is logically prior to the application of protections as set out in research ethics and regulation. Aspects of CRT design, including the fact that in a single study the units of randomization, experimentation, and observation may differ, complicate the identification of human research subjects. But the proper identification of human research subjects is important if they are to be protected from harm and exploitation, and if research ethics committees are to review CRTs efficiently. We examine the research ethics literature and international regulations to identify the core features of human research subjects, and then unify these features under a single, comprehensive definition of human research subject. We define a human research subject as any person whose interests may be compromised as a result of interventions in a research study. Individuals are only human research subjects in CRTs if: (1 they are directly intervened upon by investigators; (2 they interact with investigators; (3 they are deliberately intervened upon via a manipulation of their environment that may compromise their interests; or (4 their identifiable private information is used to generate data. Individuals who are indirectly affected by CRT study interventions, including patients of healthcare providers participating in knowledge translation CRTs, are not human research subjects unless at least one of these conditions is met.

  14. Effect of Kinesiology Tape on Measurements of Balance in Subjects With Chronic Ankle Instability: A Randomized Controlled Trial.

    Science.gov (United States)

    de-la-Torre-Domingo, Carlos; Alguacil-Diego, Isabel M; Molina-Rueda, Francisco; López-Román, Antonio; Fernández-Carnero, Josué

    2015-12-01

    To examine the immediate and prolonged effects (7d) of Kinesiology Tape (KT) on balance in subjects with chronic ankle instability using computerized dynamic posturography (CDP). A 7-day follow-up, single-blind randomized controlled trial. University community. Subjects (N=36) were screened for possible eligibility criteria, and 30 successfully completed the study protocol. Of these, 15 were randomly assigned to the experimental group (KT: 5 men, 10 women), and 15 were assigned to the control group (placebo tape: 10 men, 5 women). The experimental group was taped for a lateral ankle sprain with KT. In the control group, a placebo tape was used. Balance was assessed under the following 3 conditions: without taping, immediately after application, and after 7 days of use. The CDP device used in this study was the Smart Equitest version 8.2. CDP analysis was conducted using the Sensory Organization Test (SOT). As primaries outcome measures, the composite SOT score and composite SOT strategy were chosen. The partial score for SOT condition 2 and its strategy were considered as the secondary outcomes measures. Repeated-measures analysis of variance (ANOVA) demonstrated that there was not a significant interaction between group and time in the composite SOT score (F=.239; P=.73), SOT condition 2 (F=.333; P=.705), and SOT strategy 2 (F=.899; P=.43). Additionally, repeated-measures ANOVA showed a significant effect for time (composite SOT score: F=40.69; P≤.01; SOT condition 2: F=4.61; P=.014; SOT strategy 2: F=.899; P=.413; composite SOT strategy: F=15.14; P≤.01). Specifically, post hoc analysis showed that both groups obtained improvements in composite SOT scores immediately after tape application and 7 days of use. According to our results, the SOT scores of both the KT and control groups improved during follow-up. No differences between them were observed during the follow-up in most balance measurements. The observed changes may be related to a subjective increase

  15. Stochastic analysis model for vehicle-track coupled systems subject to earthquakes and track random irregularities

    Science.gov (United States)

    Xu, Lei; Zhai, Wanming

    2017-10-01

    This paper devotes to develop a computational model for stochastic analysis and reliability assessment of vehicle-track systems subject to earthquakes and track random irregularities. In this model, the earthquake is expressed as non-stationary random process simulated by spectral representation and random function, and the track random irregularities with ergodic properties on amplitudes, wavelengths and probabilities are characterized by a track irregularity probabilistic model, and then the number theoretical method (NTM) is applied to effectively select representative samples of earthquakes and track random irregularities. Furthermore, a vehicle-track coupled model is presented to obtain the dynamic responses of vehicle-track systems due to the earthquakes and track random irregularities at time-domain, and the probability density evolution method (PDEM) is introduced to describe the evolutionary process of probability from excitation input to response output by assuming the vehicle-track system as a probabilistic conservative system, which lays the foundation on reliability assessment of vehicle-track systems. The effectiveness of the proposed model is validated by comparing to the results of Monte-Carlo method from statistical viewpoint. As an illustrative example, the random vibrations of a high-speed railway vehicle running on the track slabs excited by lateral seismic waves and track random irregularities are analyzed, from which some significant conclusions can be drawn, e.g., track irregularities will additionally promote the dynamic influence of earthquakes especially on maximum values and dispersion degree of responses; the characteristic frequencies or frequency ranges respectively governed by earthquakes and track random irregularities are greatly different, moreover, the lateral seismic waves will dominate or even change the characteristic frequencies of system responses of some lateral dynamic indices at low frequency.

  16. A Randomized Trial to Measure the Efficacy of Applying Task Oriented Role Assignment to Improve Neonatal Resuscitation

    Science.gov (United States)

    2017-05-06

    DEPARTMENT OF THE AIR FORCE 59TH MEDICAL W ING (AETC) JOINT BASE SAN ANTONIO - LACKLAND TEXAS MEMORANOUMFORSGVT ATTN: MAJ CARRIE LITKE-WAGER...Author Litke· Wager, Carrie 0-4/Major 959/CSPS/ 59MDW/SGVT b. Mu, Thornton 0-5/LTC MCH E-ZDP-N SA MMC c. Delaney, Heather 0-4/ MAJ MCHE-ZDP-N SA MMC d...78234-2715 15 June 2016 Maj Carrie Litke-Wager, MD Brooke Army Medical Center Institutional Review Board A Randomized Trial to Measure the

  17. Predictive value of testing random urine sample to detect microalbuminuria in diabetic subjects during outpatient visit.

    Science.gov (United States)

    Bouhanick, B; Berrut, G; Chameau, A M; Hallar, M; Bled, F; Chevet, B; Vergely, J; Rohmer, V; Fressinaud, P; Marre, M

    1992-01-01

    The predictive value of random urine sample during outpatient visit to predict persistent microalbuminuria was studied in 76 Type 1, insulin-dependent diabetic subjects, 61 Type 2, non-insulin-dependent diabetic subjects, and 72 Type 2, insulin-treated diabetic subjects. Seventy-six patients attended outpatient clinic during morning, and 133 during afternoon. Microalbuminuria was suspected if Urinary Albumin Excretion (UAE) exceeded 20 mg/l. All patients were hospitalized within 6 months following outpatient visit, and persistent microalbuminuria was assessed then if UAE was between 30 and 300 mg/24 h on 2-3 occasions in 3 urines samples. Of these 209 subjects eighty-three were also screened with Microbumintest (Ames-Bayer), a semi-quantitative method. Among the 209 subjects, 71 were positive both for microalbuminuria during outpatient visit and a persistent microalbuminuria during hospitalization: sensitivity 91.0%, specificity 83.2%, concordance 86.1%, and positive predictive value 76.3% (chi-squared test: 191; p less than 10(-4)). Data were not different for subjects examined on morning, or on afternoon. Among the 83 subjects also screened with Microbumintest, 22 displayed both a positive reaction and a persistent microalbuminuria: sensitivity 76%, specificity 81%, concordance 80%, and positive predictive value 69% (chi-squared test: 126; p less than 10(-4)). Both types of screening appeared equally effective during outpatient visit. Hence, a persistent microalbuminuria can be predicted during an outpatient visit in a diabetic clinic.

  18. A general symplectic method for the response analysis of infinitely periodic structures subjected to random excitations

    Directory of Open Access Journals (Sweden)

    You-Wei Zhang

    Full Text Available A general symplectic method for the random response analysis of infinitely periodic structures subjected to stationary/non-stationary random excitations is developed using symplectic mathematics in conjunction with variable separation and the pseudo-excitation method (PEM. Starting from the equation of motion for a single loaded substructure, symplectic analysis is firstly used to eliminate the dependent degrees of the freedom through condensation. A Fourier expansion of the condensed equation of motion is then applied to separate the variables of time and wave number, thus enabling the necessary recurrence scheme to be developed. The random response is finally determined by implementing PEM. The proposed method is justified by comparison with results available in the literature and is then applied to a more complicated time-dependent coupled system.

  19. A randomized controlled trial: the effect of inulin on weight management and ectopic fat in subjects with prediabetes.

    Science.gov (United States)

    Guess, Nicola D; Dornhorst, Anne; Oliver, Nick; Bell, Jimmy D; Thomas, E Louise; Frost, Gary S

    2015-01-01

    Fat infiltration of the liver, muscle and pancreas is associated with insulin resistance and risk of diabetes. Weight loss reduces ectopic fat deposition and risk of diabetes, but is difficult to sustain to due to compensatory increases in appetite. Fermentable carbohydrates have been shown to decrease appetite and food intake, and promote weight loss in overweight subjects. In animal studies, fermentable carbohydrate reduces ectopic fat independent of weight loss. We aimed to investigate the effect of the fermentable carbohydrate inulin on weight maintenance, appetite and ectopic fat in subjects with prediabetes. Forty-four subjects with prediabetes were randomized to 18 weeks' inulin or cellulose supplementation. During weeks 1-9 (weight loss phase) all subjects had four visits with a dietitian to guide them towards a 5 % weight loss. During weeks 10-18 (weight maintenance phase) subjects continued taking their assigned supplementation and were asked to maintain the weight they had lost but were offered no further support. All subjects attended study sessions at baseline, 9 and 18 weeks for measurement of weight; assessment of adipose tissue and ectopic fat content by magnetic resonance imaging and magnetic resonance spectroscopy; glucose, insulin and GLP-1 levels following a meal tolerance test; and appetite by ad libitum meal test and visual analogue scales. Both groups lost approximately 5 % of their body weight by week nine (-5.3 ± 0.1 % vs -4.3 ± 0.4 %, p = 0.13, but the inulin group lost significantly more weight between 9 and 18 weeks (-2.3 ± 0.5 % vs -0.6 ± 0.4 %, p = 0.012). Subjects taking inulin had lower hepatic (p = 0.02) and soleus muscle (p fat content at 18 weeks compared to control even after controlling for weight loss and consumed less at the ad libitum meal test (p = 0.027). Fasting glucose significantly decreased at week nine only (p = 0.005), insulin concentrations did not change, and there

  20. Effects of progressive muscle relaxation on state anxiety and subjective well-being in people with schizophrenia: a randomized controlled trial.

    Science.gov (United States)

    Vancampfort, Davy; De Hert, Marc; Knapen, Jan; Maurissen, Katrien; Raepsaet, Julie; Deckx, Seppe; Remans, Sander; Probst, Michel

    2011-06-01

    To examine the efficacy of a single progressive muscle relaxation session compared with a control condition on state anxiety, psychological stress, fatigue and subjective well-being in patients with schizophrenia. Randomized controlled trial. An acute inpatient care unit of an University Psychiatric Centre. Sixty-four out of 88 eligible patients with schizophrenia. Patients were randomly assigned to either a single progressive muscle relaxation session during 25 minutes or a resting control condition with the opportunity to read for an equal amount of time. Before and after the single interventions the State anxiety inventory and the Subjective exercise experiences scale were completed. Effect sizes were calculated. Only within progressive muscle relaxation, participants (n=27) showed decreased state anxiety, psychological stress and fatigue and increased subjective well-being. Between-group differences in post scores were found for state anxiety, subjective well-being and psychological stress, but not for fatigue. The effect size favouring progressive muscle relaxation was 1.26 for subjective well-being and -1.25 and -1.02 for respectively state anxiety and psychological stress. Progressive muscle relaxation is highly effective in reducing acute feelings of stress and anxiety in patients with schizophrenia. A reduction in stress and state anxiety is associated with an increase in subjective well-being.

  1. Safety and pharmacokinetics of oral delta-9-tetrahydrocannabinol in healthy older subjects: a randomized controlled trial.

    Science.gov (United States)

    Ahmed, Amir I A; van den Elsen, Geke A H; Colbers, Angela; van der Marck, Marjolein A; Burger, David M; Feuth, Ton B; Rikkert, Marcel G M Olde; Kramers, Cornelis

    2014-09-01

    There is a great concern about the safety of THC-based drugs in older people (≥65 years), as most of THC-trials did not include such group. In this phase 1, randomized, double-blind, double-dummy, placebo-controlled, cross-over trial, we evaluated the safety and pharmacokinetics of three oral doses of Namisol(®), a novel THC in tablet form, in older subjects. Twelve healthy older subjects (6 male; mean age 72±5 years) randomly received a single oral dose of 3mg, 5mg, or 6.5mg of THC or matching placebo, in a crossover manner, on each intervention day. The data for 11 subjects were included in the analysis. The data of 1 subject were excluded due to non-compliance to study medication. THC was safe and well tolerated. The most frequently reported adverse events (AEs) were drowsiness (27%) and dry mouth (11%). Subjects reported more AEs with THC 6.5mg than with 3mg (p=0.048), 5mg (p=0.034) and placebo (p=0.013). There was a wide inter-individual variability in plasma concentrations of THC. Subjects for whom the Cmax fell within the sampling period (over 2h), Cmax was 1.42-4.57ng/mL and Tmax was 67-92min. The AUC0-2h (n=11) was 1.67-3.51ng/mL. Overall, the pharmacodynamic effects of THC were smaller than effects previously reported in young adults. In conclusion, THC appeared to be safe and well tolerated by healthy older individuals. Data on safety and effectiveness of THC in frail older persons are urgently required, as this population could benefit from the therapeutic applications of THC. Copyright © 2014 Elsevier B.V. and ECNP. All rights reserved.

  2. EFFECTIVENESS OF MOTOR TASK INTERFERENCE DURING GAIT IN SUBJECTS WITH PARKINSON'S DISEASE: A RANDOMIZED CONTROLLED TRAIL

    Directory of Open Access Journals (Sweden)

    Jaya ShankerTedla

    2017-04-01

    Full Text Available Background: In this study, was to evaluated the effectiveness of motor task and cognitive task interference while walking to improve gait parameters of subjects with Parkinson’s disease. Methods: In this Randomized Controlled trial, 30 subjects with Parkinson’s disease of age group between 50and 70 years randomly divided into two groups. The first group had motor task interference, and the second group had calculation task interference while walking along with conventional physical therapy. Gait parameters recorded as outcome measures. Both the groups received 1-hour training for three weeks for one month. Results: As per the paired t-test values, there was significant (p<0.001 improvement in the gait parameters for both the group's pre and post training. Motor task interference showed better improvements than calculation-task interference group among subjects with Parkinson’s disease in all the gait parameters measured with a p-value less than 0.001. Conclusion: To improve the gait parameters for mild to moderately disabled patients with Parkinson’s disease, the dual task training by using motor task while gait training along with conventional Physical Therapy will be more useful than using cognitive task.

  3. Optimal positions and parameters of translational and rotational mass dampers in beams subjected to random excitation

    Science.gov (United States)

    Łatas, Waldemar

    2018-01-01

    The problem of vibrations of the beam with the attached system of translational and rotational dynamic mass dampers subjected to random excitations with peaked power spectral densities, is presented in the hereby paper. The Euler-Bernoulli beam model is applied, while for solving the equation of motion the Galerkin method and the Laplace time transform are used. The obtained transfer functions allow to determine power spectral densities of the beam deflection and other dependent variables. Numerical examples present simple optimization problems of mass dampers parameters for local and global objective functions.

  4. Efficacy of an orlistat-resveratrol combination for weight loss in subjects with obesity: A randomized controlled trial.

    Science.gov (United States)

    Arzola-Paniagua, María Angélica; García-Salgado López, Enrique Raúl; Calvo-Vargas, Cesar G; Guevara-Cruz, Martha

    2016-07-01

    To evaluate the efficacy of an orlistat-resveratrol (O-R) combination in subjects with obesity over a 6-month period. This study was a double-blind, parallel, randomized controlled clinical trial. Patients fulfilling the selection criteria (age from 20 to 60 years and body mass index (BMI) ≥30 and ≤39.9 kg/m(2) ) consumed an energy-reduced diet with 500 fewer calories than their usual diet for 2 weeks. Then the participants were randomly assigned to four groups, placebo, resveratrol, orlistat, or O-R, and they consumed the energy-reduced diet for 6 months. The study consisted of seven visits. During each visit, a 24-h recall was performed, along with measurements of anthropometric and serum biochemical parameters. A total of 161 participants were selected. Of these, 84 participants completed the study. A significant weight loss of -6.82 kg (95% CI -8.37 to -5.26) was observed in the O-R group compared with -3.50 kg (-5.05 to -1.95, P = 0.021) in the placebo group. In contrast, the -6.02 kg (-7.68 to -4.36) orlistat and -4.68 kg (-6.64 to -2.71) resveratrol monotherapy losses did not significantly differ from the placebo. Significant decreases in BMI, waist circumference, fat mass, triglycerides, leptin, and leptin/adiponectin ratio were observed with the O-R combination. The O-R combination was the most effective weight loss treatment. © 2016 The Obesity Society.

  5. Pharmacodynamics and pharmacokinetics of AMG 531, a thrombopoiesis-stimulating peptibody, in healthy Japanese subjects: a randomized, placebo-controlled study.

    Science.gov (United States)

    Kumagai, Yuji; Fujita, Tomoe; Ozaki, Machiko; Sahashi, Kunihiko; Ohkura, Masayuki; Ohtsu, Tomoko; Arai, Yoshihiro; Sonehara, Yusuke; Nichol, Janet L

    2007-12-01

    AMG 531 is a novel thrombopoiesis-stimulating peptibody being investigated for the treatment of chronic immune thrombocytopenic purpura. This double-blind, phase I study evaluated the safety, pharmacodynamics, and pharmacokinetics of AMG 531 in healthy Japanese men. Thirty subjects were randomly assigned 4:1 (AMG 531/placebo) to receive 1 dose of AMG 531 (0.3, 1, or 2 microg/kg) or placebo by subcutaneous injection; subjects were evaluated for 6 weeks. AMG 531 was generally well tolerated, with adverse events similar to placebo. Treatment-related adverse events (headache, "feeling hot," malaise) were reported for 5 of 24 AMG 531-treated subjects. Platelets generated after exposure to AMG 531 functioned normally. Four of 8 subjects receiving 1 microg/kg and 7 of 8 receiving 2 microg/kg had platelet count increases > or =1.5-fold over baseline, an effect similar to that seen in non-Japanese subjects. Serum AMG 531 concentrations were below the lower limit of quantification in all but 2 subjects receiving 2 microg/kg.

  6. Selection bias and subject refusal in a cluster-randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Rochelle Yang

    2017-07-01

    Full Text Available Abstract Background Selection bias and non-participation bias are major methodological concerns which impact external validity. Cluster-randomized controlled trials are especially prone to selection bias as it is impractical to blind clusters to their allocation into intervention or control. This study assessed the impact of selection bias in a large cluster-randomized controlled trial. Methods The Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care (ICARE study examined the impact of a remote pharmacist-led intervention in twelve medical offices. To assess eligibility, a standardized form containing patient demographics and medical information was completed for each screened patient. Eligible patients were approached by the study coordinator for recruitment. Both the study coordinator and the patient were aware of the site’s allocation prior to consent. Patients who consented or declined to participate were compared across control and intervention arms for differing characteristics. Statistical significance was determined using a two-tailed, equal variance t-test and a chi-square test with adjusted Bonferroni p-values. Results were adjusted for random cluster variation. Results There were 2749 completed screening forms returned to research staff with 461 subjects who had either consented or declined participation. Patients with poorly controlled diabetes were found to be significantly more likely to decline participation in intervention sites compared to those in control sites. A higher mean diastolic blood pressure was seen in patients with uncontrolled hypertension who declined in the control sites compared to those who declined in the intervention sites. However, these findings were no longer significant after adjustment for random variation among the sites. After this adjustment, females were now found to be significantly more likely to consent than males (odds ratio = 1.41; 95% confidence interval = 1.03, 1

  7. Multiple-mode large deflection random response of beams with nonlinear damping subjected to acoustic excitation

    Science.gov (United States)

    Prasad, C. B.; Mei, Chuh

    1987-01-01

    Multiple-mode nonlinear analysis is carried out for beams subjected to acoustic excitation. Effects of both nonlinear damping and large-deflection are included in the analysis in an attempt to explain the experimental phenomena of aircraft panels excited at high sound pressure levels; that is the broadening of the strain response peaks and the increase of modal frequency. An amplitude dependent nonlinear damping model is used in the anlaysis to study the effects and interactions of multiple modes, nonlinear stiffness and nonlinear damping on the random response of beams. Mean square maximum deflection, mean square maximum strain, and spectral density function of maximum strain for simple supported and clamped beams are obtained. It is shown analytically that nonlinear damping contributes significantly to the broadening of the response peak and to the mean square deflection and strain.

  8. Assignment of adverse event indexing terms in randomized clinical trials involving spinal manipulative therapy: an audit of records in MEDLINE and EMBASE databases.

    Science.gov (United States)

    Gorrell, Lindsay M; Engel, Roger M; Lystad, Reidar P; Brown, Benjamin T

    2017-03-14

    Reporting of adverse events in randomized clinical trials (RCTs) is encouraged by the authors of The Consolidated Standards of Reporting Trials (CONSORT) statement. With robust methodological design and adequate reporting, RCTs have the potential to provide useful evidence on the incidence of adverse events associated with spinal manipulative therapy (SMT). During a previous investigation, it became apparent that comprehensive search strategies combining text words with indexing terms was not sufficiently sensitive for retrieving records that were known to contain reports on adverse events. The aim of this analysis was to compare the proportion of articles containing data on adverse events associated with SMT that were indexed in MEDLINE and/or EMBASE and the proportion of those that included adverse event-related words in their title or abstract. A sample of 140 RCT articles previously identified as containing data on adverse events associated with SMT was used. Articles were checked to determine if: (1) they had been indexed with relevant terms describing adverse events in the MEDLINE and EMBASE databases; and (2) they mentioned adverse events (or any related terms) in the title or abstract. Of the 140 papers, 91% were MEDLINE records, 85% were EMBASE records, 81% were found in both MEDLINE and EMBASE records, and 4% were not in either database. Only 19% mentioned adverse event-related text words in the title or abstract. There was no significant difference between MEDLINE and EMBASE records in the proportion of available papers (p = 0.078). Of the 113 papers that were found in both MEDLINE and EMBASE records, only 3% had adverse event-related indexing terms assigned to them in both databases, while 81% were not assigned an adverse event-related indexing term in either database. While there was effective indexing of RCTs involving SMT in the MEDLINE and EMBASE databases, there was a failure of allocation of adverse event indexing terms in both databases. We

  9. Assignment of adverse event indexing terms in randomized clinical trials involving spinal manipulative therapy: an audit of records in MEDLINE and EMBASE databases

    Directory of Open Access Journals (Sweden)

    Lindsay M. Gorrell

    2017-03-01

    Full Text Available Abstract Background Reporting of adverse events in randomized clinical trials (RCTs is encouraged by the authors of The Consolidated Standards of Reporting Trials (CONSORT statement. With robust methodological design and adequate reporting, RCTs have the potential to provide useful evidence on the incidence of adverse events associated with spinal manipulative therapy (SMT. During a previous investigation, it became apparent that comprehensive search strategies combining text words with indexing terms was not sufficiently sensitive for retrieving records that were known to contain reports on adverse events. The aim of this analysis was to compare the proportion of articles containing data on adverse events associated with SMT that were indexed in MEDLINE and/or EMBASE and the proportion of those that included adverse event-related words in their title or abstract. Methods A sample of 140 RCT articles previously identified as containing data on adverse events associated with SMT was used. Articles were checked to determine if: (1 they had been indexed with relevant terms describing adverse events in the MEDLINE and EMBASE databases; and (2 they mentioned adverse events (or any related terms in the title or abstract. Results Of the 140 papers, 91% were MEDLINE records, 85% were EMBASE records, 81% were found in both MEDLINE and EMBASE records, and 4% were not in either database. Only 19% mentioned adverse event-related text words in the title or abstract. There was no significant difference between MEDLINE and EMBASE records in the proportion of available papers (p = 0.078. Of the 113 papers that were found in both MEDLINE and EMBASE records, only 3% had adverse event-related indexing terms assigned to them in both databases, while 81% were not assigned an adverse event-related indexing term in either database. Conclusions While there was effective indexing of RCTs involving SMT in the MEDLINE and EMBASE databases, there was a failure of

  10. Reinforcement of intestinal epithelial barrier by arabinoxylans in overweight and obese subjects: A randomized controlled trial: Arabinoxylans in gut barrier.

    Science.gov (United States)

    Salden, Bouke N; Troost, Freddy J; Wilms, Ellen; Truchado, Pilar; Vilchez-Vargas, Ramiro; Pieper, Dietmar H; Jáuregui, Ruy; Marzorati, Massimo; van de Wiele, Tom; Possemiers, Sam; Masclee, Ad A

    2017-02-03

    Obesity and metabolic diseases are associated with alterations in microbial composition and impaired gut barrier. Previous in vitro and animal studies have shown that arabinoxylans (AX) have the potential to modulate gut microbiota and gut barrier and therefore could have a protective role. Primary aim of the study was to investigate the effect of AX on intestinal permeability. Secondary aims included the effect of AX on gene transcription and protein expression of tight junctions (TJ), intestinal microbiota composition and activity, immune response and metabolic markers in overweight and obese individuals. In this randomized, double-blind, placebo-controlled trial, 47 overweight subjects were randomly assigned to groups receiving 7.5 g/d AX (n = 16), 15 g/d AX (n = 17) or 15 g/d placebo (n = 14) for 6 wks. Intestinal permeability was investigated using a multi-sugar test. Sigmoid colon tissue was obtained from a subgroup (n = 26) for analyzing gene transcription and mucosal expression of TJ proteins. Fecal samples were collected to assess microbial composition and activity. Furthermore, the production of cytokines by stimulated peripheral blood mononuclear cells (PBMCs) was examined. Blood was also sampled for measuring metabolic markers. No significant changes in gastrointestinal permeability and TJ protein expression were observed after 6 wks AX supplementation compared to placebo. However, gene transcription of occludin was upregulated in the 7.5 g AX group, and transcription of claudin-3 and claudin-4 were upregulated in the 15 g AX group compared to placebo. Furthermore, fecal microbiota diversity was decreased after 6 wks 15 g AX treatment, but no change in relative abundance of dominant phyla was observed. AX intake significantly decreased fecal pH and increased fecal concentrations of total SCFAs, acetate, propionate and butyrate, compared to placebo. Additionally, a decreased TNFα production by stimulated PBMCs was observed after 15

  11. Effects of High-Dose Capsaicin on TMD Subjects: A Randomized Clinical Study.

    Science.gov (United States)

    Campbell, B K; Fillingim, R B; Lee, S; Brao, R; Price, D D; Neubert, J K

    2017-01-01

    Temporomandibular joint disorder (TMD) is a complex musculoskeletal disorder that presents with pain, limited jaw opening, and abnormal noises in the temporomandibular joint. Despite the significant impact that TMD has in terms of suffering and financial burden, relatively few new treatments have emerged; therefore, development of novel treatments to treat TMD pain remains a high priority. The rationale of this study was to use a double-blind, vehicle-controlled clinical trial to evaluate the effects of a high-concentration (8%) capsaicin cream on TMD. This is based on the hypothesis that targeting TRP vanilloid subfamily member 1 (TRPV1) for pain control may provide a novel method for pain relief in TMD patients. TRPV1 is primarily expressed on a population of nociceptive-specific neurons and provides a candidate target for the development of pain treatments. Capsaicin is the primary agonist for TRPV1 and has been used previously in relatively low doses (0.025% to 0.075%) as a therapeutic for a variety of pain disorders, including postherpetic neuralgia and osteoarthritis; however, analgesic efficacy remains equivocal. TMD and healthy control subjects were assigned to either an active capsaicin or vehicle control group. The treatments were applied for 2 h and then removed. Quantitative sensory testing (QST) was completed prior to drug application (baseline), 2 h after drug application, and 1 wk later. Perceived pain intensity was measured using a visual analog scale (VAS) following capsaicin or vehicle cream application. Significantly lower pain was reported in the week after application in the capsaicin-treated TMD subjects. For QST measures, there was a decreased thermal pain threshold 2 h after capsaicin application for both the control and TMD groups, but this resolved within a week. Capsaicin had no effect on pressure pain threshold or mechanical sensitivity in both TMD and healthy individuals. This study demonstrates that 8% topical capsaicin therapy is a

  12. Strategy-Proof Stochastic Assignment

    OpenAIRE

    Erdil, A.

    2013-01-01

    I study strategy-proof assignment mechanisms where the agents reveal their preference rankings over the available objects. A stochastic mechanism returns lotteries over deterministic assignments, and mechanisms are compared according to first-order stochastic dominance. I show that non-wasteful strategy-proof mechanisms are not dominated by strategy-proof mechanisms, however nonwastefulness is highly restrictive when the mechanism involves randomization. In fact, the Random Priority mechanism...

  13. Cost-effectiveness of nutritional intervention in elderly subjects after hip fracture. A randomized controlled trial.

    Science.gov (United States)

    Wyers, C E; Reijven, P L M; Evers, S M A A; Willems, P C; Heyligers, I C; Verburg, A D; van Helden, S; Dagnelie, P C

    2013-01-01

    Hip fracture patients can benefit from nutritional supplementation during their recovery. Up to now, cost-effectiveness evaluation of nutritional intervention in these patients has not been performed. Costs of nutritional intervention are relatively low as compared with medical costs. Cost-effectiveness evaluation shows that nutritional intervention is likely to be cost-effective. Previous research on the effect of nutritional intervention on clinical outcome in hip fracture patients yielded contradictory results. Cost-effectiveness of nutritional intervention in these patients remains unknown. The aim of this study was to evaluate cost-effectiveness of nutritional intervention in elderly subjects after hip fracture from a societal perspective. Open-label, multi-centre randomized controlled trial investigating cost-effectiveness of intensive nutritional intervention comprising regular dietetic counseling and oral nutritional supplementation for 3 months postoperatively. Patients allocated to the control group received care as usual. Costs, weight and quality of life were measured at baseline and at 3 and 6 months postoperatively. Incremental cost-effectiveness ratios (ICERs) were calculated for weight at 3 months and quality adjusted life years (QALYs) at 6 months postoperatively. Of 152 patients enrolled, 73 were randomized to the intervention group and 79 to the control group. Mean costs of the nutritional intervention was 613 Euro. Total costs and subcategories of costs were not significantly different between both groups. Based on bootstrapping of ICERs, the nutritional intervention was likely to be cost-effective for weight as outcome over the 3-month intervention period, regardless of nutritional status at baseline. With QALYs as outcome, the probability for the nutritional intervention being cost-effective was relatively low, except in subjects aged below 75 years. Intensive nutritional intervention in elderly hip fracture patients is likely to be cost

  14. Contrasting Complement Control, Temporal Adjunct Control and Controlled Verbal Gerund Subjects in ASD: The Role of Contextual Cues in Reference Assignment

    OpenAIRE

    Janke, Vikki; Perovic, Alexandra

    2017-01-01

    This study examines two complex syntactic dependencies (complement control and sentence-final temporal adjunct control) and one pragmatic dependency (controlled verbal gerund subjects) in children with ASD. Sixteen high-functioning (HFA) children (aged 6 to 16) with a diagnosis of autism and no language impairment, matched on age, gender and non-verbal MA to one TD control group, and on age, gender and verbal MA to another TD control group, undertook three picture-selection tasks. Task 1 meas...

  15. Contrasting complement control, temporal adjunct control and controlled verbal gerund subjects in ASD: The role of contextual cues in reference assignment

    OpenAIRE

    Janke, V.; Perovic, A.

    2017-01-01

    This study examines two complex syntactic dependencies (complement control and sentence-final temporal adjunct control) and one pragmatic dependency (controlled verbal gerund subjects) in children with ASD. Sixteen high-functioning (HFA) children (aged 6–16) with a diagnosis of autism and no language impairment, matched on age, gender and non-verbal MA to one TD control group, and on age, gender and verbal MA to another TD control group, undertook three picture-selection tasks....

  16. Oxytocin for male subjects with autism spectrum disorder and comorbid intellectual disabilities: A randomized pilot study

    Directory of Open Access Journals (Sweden)

    Toshio eMunesue

    2016-01-01

    Full Text Available Approximately half of autism spectrum disorder (ASD individual suffer from comorbid intellectual disabilities (ID. Oxytocin (OXT receptors are highly expressed in temporal lobe structures and are likely to play a modulatory role in excitatory/inhibitory balance, at least based on animal model findings. Thus, it is feasible that in the highly representative group of Kanner type ASD subjects OXT could have a beneficial effect on social communication and social interaction. The aim of this pilot study was to investigate the feasibility and adverse events, such as epilepsy, of the long-term administration of intranasal OXT for adolescent and adult ASD subjects with ID because such patients frequently have seizures. We also addressed the question on how to scale the OXT effects to the core symptoms of social deficits because of the relative difficulty in obtaining objective measurements. Twenty-nine males (aged 15-40 years old participated in a randomized, double-blind, placebo-controlled crossover study (each for 8 weeks with OXT (16 international units per day. Except for seizures experienced by one participant, other serious adverse events did not occur. The primary and secondary outcomes measured using the Childhood Autism Rating Scale and several standard scales, respectively, revealed no difference between the OXT and placebo groups. Instead, in an exploratory analysis, the social interactions observed in the play sessions or in daily-life were significantly more frequent in the initial half period in the OXT-first arm of the crossover trial. There were also significant correlations between the plasma OXT concentration and subscale scores for irritability on the Aberrant Behavior Checklist. In conclusion, this pilot study demonstrates that long-term administration of intranasal OXT is tolerable in a representative cohort of ASD individuals with ID and suggests that future multicenter trials of OXT are warranted and should include measurements

  17. Gastrointestinal tolerance of low FODMAP oral nutrition supplements in healthy human subjects: a randomized controlled trial.

    Science.gov (United States)

    Erickson, Jennifer; Korczak, Renee; Wang, Qi; Slavin, Joanne

    2017-05-25

    There has been increasing interest in utilizing a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) for the treatment of irritable bowel syndrome (IBS), a functional gastrointestinal disease. While studies have indicated that this diet can be effective at symptom reduction, it is a restrictive diet and patients may find it challenging to find low FODMAP products to meet their nutrient needs. The primary objective of this study was to assess the gastrointestinal (GI) tolerance of three low FODMAP oral nutrition supplements (ONS) in healthy adults. A double-blind randomized controlled crossover study was conducted in 21 healthy adults (19-32 years). Fasted subjects consumed one of four treatments at each visit, with a one week wash out period between visits. Each participant received all treatments. Treatments included three low FODMAP ONS formulas (A, B, and C) as well as a positive control consisting of 5 g fructooligosaccharides (FOS) mixed in lactose-free milk. Breath hydrogen was measured at baseline, 1, 2, 3, and 4 h post treatment consumption. Subjective GI symptom questionnaires were completed at baseline, 0.5, 1, 1.5, 2, 3, 4, 12, 24 and 48 h following treatment consumption. Mean breath hydrogen concentrations and baseline corrected area under the curve for both breath hydrogen and GI symptoms were analyzed and compared between treatments. Significance was determined at P FODMAP ONS beverages at 3 and 4 h after consumption. There were no differences in GI symptom response between treatments. All treatments were well tolerated in healthy participants. The low FODMAP formulas resulted in a lower breath hydrogen response compared to the positive control, and may be better tolerated in individuals with IBS. More research should be conducted to better understand the GI tolerance of low FODMAP ONS in individuals with IBS. The protocol for this study was registered on ClinicalTrials.gov in January 2016 (Clinical

  18. Measles virus antibody responses in children randomly assigned to receive standard-titer edmonston-zagreb measles vaccine at 4.5 and 9 months of age, 9 months of age, or 9 and 18 months of age

    DEFF Research Database (Denmark)

    Martins, Cesario; Garly, May-Lill; Bale, Carlitos

    2014-01-01

    The World Health Organization recommends administration of measles vaccine (MV) at age 9 months in low-income countries. We tested the measles virus antibody response at 4.5, 9, 18, and 24 months of age for children randomly assigned to receive standard-titer Edmonston-Zagreb MV at 4.5 and 9 months...

  19. Adolescent Substance Use in the Multimodal Treatment Study of Attention-Deficit/Hyperactivity Disorder (ADHD) (MTA) as a Function of Childhood ADHD, Random Assignment to Childhood Treatments, and Subsequent Medication

    Science.gov (United States)

    Molina, Brooke S. G.; Hinshaw, Stephen P.; Arnold, L. Eugene; Swanson, James M.; Pelham, William E.; Hechtman, Lily; Hoza, Betsy; Epstein, Jeffery N.; Wigal, Timothy; Abikoff, Howard B.; Greenhill, Laurence L.; Jensen, Peter S.; Wells, Karen C.; Vitiello, Benedetto; Gibbons, Robert D.; Howard, Andrea; Houck, Patricia R.; Hur, Kwan; Lu, Bo; Marcus, Sue

    2013-01-01

    Objective: To determine long-term effects on substance use and substance use disorder (SUD), up to 8 years after childhood enrollment, of the randomly assigned 14-month treatments in the multisite Multimodal Treatment Study of Children with Attention-Deficit/Hyperactivity Disorder (MTA; n = 436); to test whether medication at follow-up, cumulative…

  20. Pharmacokinetic profile of armodafinil in healthy subjects: pooled analysis of data from three randomized studies.

    Science.gov (United States)

    Darwish, Mona; Kirby, Mary; Hellriegel, Edward T; Yang, Ronghua; Robertson, Philmore

    2009-01-01

    Armodafinil (R-modafinil) is the R- and longer-lasting isomer of the racemic compound modafinil, a wakefulness-promoting medication. Armodafinil is eliminated approximately three times more slowly than the S-isomer of racemic modafinil. Published studies have demonstrated the efficacy of armodafinil for treating excessive sleepiness associated with obstructive sleep apnoea, shift work disorder and narcolepsy. The objectives of this study were to describe the pharmacokinetic profile, tolerability and safety of armodafinil in healthy subjects. Pooled pharmacokinetic data from three separate randomized studies in 119 healthy subjects who received single or multiple (once daily for up to 14 days) oral doses of armodafinil ranging between 50 and 400 mg were analysed. The impact of food on the single-dose pharmacokinetic profile of armodafinil was also assessed in subjects following an overnight fast and after the consumption of a standard fatty meal. Armodafinil was readily absorbed and exhibited linear pharmacokinetics over the 50-400 mg dose range. Peak plasma concentrations were reached around 2 hours after administration in the fasted state. Food had no effect on the overall bioavailability of armodafinil; however, the peak concentration was delayed by approximately 2-4 hours. In the multiple-dose study, dose proportionality was confirmed by linear regression analyses of the log-transformed area under the plasma concentration versus time curve (AUC) and maximum plasma concentration (Cmax) values as a function of dose. After reaching the peak, plasma concentrations of armodafinil declined in a monophasic manner, with a mean elimination half-life of approximately 15 hours. Steady state appeared to be reached within 7 days. At steady state, the systemic exposure to armodafinil was 1.8 times that observed after single-dose administration. Armodafinil was generally well tolerated, the most frequent adverse events being headache, dizziness and nausea. In the present

  1. Does green tea affect postprandial glucose, insulin and satiety in healthy subjects: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lindstedt Sandra

    2010-11-01

    Full Text Available Abstract Background Results of epidemiological studies have suggested that consumption of green tea could lower the risk of type 2 diabetes. Intervention studies show that green tea may decrease blood glucose levels, and also increase satiety. This study was conducted to examine the postprandial effects of green tea on glucose levels, glycemic index, insulin levels and satiety in healthy individuals after the consumption of a meal including green tea. Methods The study was conducted on 14 healthy volunteers, with a crossover design. Participants were randomized to either 300 ml of green tea or water. This was consumed together with a breakfast consisting of white bread and sliced turkey. Blood samples were drawn at 0, 15, 30, 45, 60, 90, and 120 minutes. Participants completed several different satiety score scales at the same times. Results Plasma glucose levels were higher 120 min after ingestion of the meal with green tea than after the ingestion of the meal with water. No significant differences were found in serum insulin levels, or the area under the curve for glucose or insulin. Subjects reported significantly higher satiety, having a less strong desire to eat their favorite food and finding it less pleasant to eat another mouthful of the same food after drinking green tea compared to water. Conclusions Green tea showed no glucose or insulin-lowering effect. However, increased satiety and fullness were reported by the participants after the consumption of green tea. Trial registration number NCT01086189

  2. Contrasting Complement Control, Temporal Adjunct Control and Controlled Verbal Gerund Subjects in ASD: The Role of Contextual Cues in Reference Assignment.

    Science.gov (United States)

    Janke, Vikki; Perovic, Alexandra

    2017-01-01

    This study examines two complex syntactic dependencies (complement control and sentence-final temporal adjunct control) and one pragmatic dependency (controlled verbal gerund subjects) in children with ASD. Sixteen high-functioning (HFA) children (aged 6-16) with a diagnosis of autism and no language impairment, matched on age, gender and non-verbal MA to one TD control group, and on age, gender and verbal MA to another TD control group, undertook three picture-selection tasks. Task 1 measured their base-line interpretations of the empty categories (ec). Task 2 preceded these sentence sets with a weakly established topic cueing an alternative referent and Task 3 with a strongly established topic cueing an alternative referent. In complement control (Ron persuaded Hermione ec to kick the ball) and sentence-final temporal adjunct control (Harry tapped Luna while ec feeding the owl), the reference of the ec is argued to be related obligatorily to the object and subject respectively. In controlled verbal-gerund subjects (VGS) (ec Rowing the boat clumsily made Luna seasick), the ec's reference is resolved pragmatically. Referent choices across the three tasks were compared. TD children chose the object uniformly in complement control across all tasks but in adjunct control, preferences shifted toward the object in Task 3. In controlled VGSs, they exhibited a strong preference for an internal-referent interpretation in Task 1, which shifted in the direction of the cues in Tasks 2 and 3. HFA children gave a mixed performance. They patterned with their TD counterparts on complement control and controlled VGSs but performed marginally differently on adjunct control: no TD groups were influenced by the weakly established topic in Task 2 but all groups were influenced by the strongly established topic in Task 3. HFA children were less influenced than the TD children, resulting in their making fewer object choices overall but revealing parallel patterns of performance. In this

  3. A Solution Method for Linear and Geometrically Nonlinear MDOF Systems with Random Properties subject to Random Excitation

    DEFF Research Database (Denmark)

    Micaletti, R. C.; Cakmak, A. S.; Nielsen, Søren R. K.

    structural properties. The resulting state-space formulation is a system of ordinary stochastic differential equations with random coefficient and deterministic initial conditions which are subsequently transformed into ordinary stochastic differential equations with deterministic coefficients and random...... initial conditions. This transformation facilitates the derivation of differential equations which govern the evolution of the unconditional statistical moments of response. Primary consideration is given to linear systems and systems with odd polynomial nonlinearities, for in these cases...... there is a significant reduction in the number of equations to be solved. The method is illustrated for a five-story shear-frame structure with nonlinear interstory restoring forces and random damping and stiffness properties. The results of the proposed method are compared to those estimated by extensive Monte Carlo...

  4. Persistent effects of cognitive-behavioral stress management on cortisol responses to acute stress in healthy subjects--a randomized controlled trial.

    Science.gov (United States)

    Hammerfald, K; Eberle, C; Grau, M; Kinsperger, A; Zimmermann, A; Ehlert, U; Gaab, J

    2006-04-01

    Psychosocial stress leads to a release of cortisol. While this psychoneuroendocrine response helps to maintain physiological as well as psychological equilibrium under stress, exaggerated secretion of cortisol has been shown to have negative effects on somatic health and cognitive functioning. The study set out to examine the long-term effects of cognitive-behavioral stress management training on cortisol stress responses in healthy men and women. Eighty-three healthy subjects were randomly assigned to cognitive-behavioral stress management (CBSM) training or a control condition. Four months after the CBSM, 76 subjects underwent a standardized psychosocial stress test. Salivary cortisol responses were assessed repeatedly before and after the stress test. Subjects in the CBSM group showed significantly reduced cortisol stress responses. With regard to gender, this effect was observed in both men and women. However, the magnitude of the CBSM effect on cortisol responses was smaller in women than in men. Use of oral contraceptives in women influenced the cortisol response, but did not have an impact on the CBSM effect on cortisol. The results show that the previously reported attenuation of cortisol stress responses through CBSM persists and are observable in both men and women. Since stress-induced alterations of hypothalamus pituitary adrenal axis functioning are discussed to be involved in the onset and maintenance of both somatic and psychiatric conditions, similar interventions could be used for prevention and therapy of these detrimental stress effects.

  5. Coping and health-related quality of life in men with prostate cancer randomly assigned to hormonal medication or close monitoring.

    Science.gov (United States)

    Green, Heather J; Pakenham, Kenneth I; Headley, Betty C; Gardiner, Robert A

    2002-01-01

    Prostatic carcinoma and its treatment have been associated with adverse effects on health-related quality of life (HRQoL). Individual differences in appraisal and coping have been suggested to mediate these HRQoL outcomes. A randomized trial of 65 men with non-localized prostate cancer compared several treatments and tested associations between appraisal, coping, and HRQoL. These patients, and 16 community volunteers matched for age and general health, undertook psychosocial assessments before treatment and after 6 months of treatment. Compared with baseline assessments, men on hormonal treatments reported impaired sexual function. Groups did not differ on emotional distress, existential satisfaction, subjective cognitive function, physical symptoms, or social and role functioning. For individuals, hormonal treatments were more frequently associated with decreased sexual, social and role functioning, but were also associated with improved physical symptoms. In hierarchical regression analysis, HRQoL was lower for men who had more comorbid illnesses, a history of neurological dysfunction, higher threat appraisals, or higher use of coping strategies at baseline. These results showed that pharmacological hormonal ablation for prostate cancer can improve or decrease HRQoL in different domains. HRQoL in men with prostate cancer was associated more strongly with appraisal and coping than with medical variables. Copyright 2002 John Wiley & Sons, Ltd.

  6. Efficacy of Visual-Acoustic Biofeedback Intervention for Residual Rhotic Errors: A Single-Subject Randomization Study

    Science.gov (United States)

    Byun, Tara McAllister

    2017-01-01

    Purpose: This study documented the efficacy of visual-acoustic biofeedback intervention for residual rhotic errors, relative to a comparison condition involving traditional articulatory treatment. All participants received both treatments in a single-subject experimental design featuring alternating treatments with blocked randomization of…

  7. Metabolic Effects of Replacing Sugar-Sweetened Beverages with Artificially-Sweetened Beverages in Overweight Subjects with or without Hepatic Steatosis: A Randomized Control Clinical Trial

    Directory of Open Access Journals (Sweden)

    Vanessa Campos

    2017-02-01

    Full Text Available Objective: Addition of fructose to the diet of normal weight and overweight subjects can increase postprandial plasma triglyceride and uric acid concentration. We, therefore, assessed whether replacing sugar-sweetened beverages (SSB with artificially-sweetened beverages (ASB in the diet of overweight and obese subjects would decrease these parameters. Methods: Twenty-six participants of the REDUCS study, which assessed the effects of replacing SSB by ASB over 12 weeks on intra-hepatocellular lipid concentration, were included in this sub-analysis. All were studied after a four-week run-in period during which they consumed their usual diet and SSBs, and after a 12-week intervention in which they were randomly assigned to replace their SSBs with ASBs (ASB arm or to continue their usual diet and SSBs (control arm, CTRL. At the end of run-in (week 4 and again at the end of intervention (week 16, they took part in an 8.5 h metabolic investigation during which their plasma glucose, insulin, glucagon, lactate, triglyceride (TG, non-esterified fatty acids (NEFA, and uric acid concentrations were measured over a 30 min fasting period (−30–0 min, then every 2 h over 480 min. with ingestion of standard breakfast at time 0 min and a standard lunch at time 240 min. Breakfast and lunch were consumed together with a 3.3 dL SSB at week 4 and with either an ASB (ASB arm or a SSB (CTRL arm at week 16. After analyzing the whole group, a secondary analysis was performed on 14 subjects with hepatic steatosis (seven randomized to ASB, seven to CTRL and 12 subjects without hepatic steatosis (six randomized to ASB and six to CTRL. Results: Ingestion of meals increased plasma glucose, insulin, glucagon, lactate, and TG concentrations and decreased NEFA concentrations, but with no significant difference of integrated postprandial responses between week 4 and week 16 in both ASB and CTRL, except for a slightly decreased glucagon response in ASB. There was, however, no

  8. The effects of mindfulness-based stress reduction on objective and subjective sleep parameters in women with breast cancer: a randomized controlled trial.

    Science.gov (United States)

    Lengacher, Cecile A; Reich, Richard R; Paterson, Carly L; Jim, Heather S; Ramesar, Sophia; Alinat, Carissa B; Budhrani, Pinky H; Farias, Jerrica R; Shelton, Melissa M; Moscoso, Manolete S; Park, Jong Y; Kip, Kevin E

    2015-04-01

    The purpose of this study was to investigate the effects of mindfulness-based stress reduction for breast cancer survivors (MBSR(BC)) on multiple measures of objective and subjective sleep parameters among breast cancer survivors (BCS). Data were collected using a two-armed randomized controlled design among BCS enrolled in either a 6-week MBSR(BC) program or a usual care (UC) group with a 12-week follow-up. The present analysis is a subset of the larger parent trial (ClinicalTrials.gov Identifier: NCT01177124). Seventy-nine BCS participants (mean age 57 years), stages 0-III, were randomly assigned to either the formal (in-class) 6-week MBSR(BC) program or UC. Subjective sleep parameters (SSP) (i.e., sleep diaries and the Pittsburgh Sleep Quality Index (PSQI)) and objective sleep parameters (OSP) (i.e., actigraphy) were measured at baseline, 6 weeks, and 12 weeks after completing the MBSR(BC) or UC program. Results showed indications of a positive effect of MBSR(BC) on OSP at 12 weeks on sleep efficiency (78.2% MBSR(BC) group versus 74.6% UC group, p = 0.04), percent of sleep time (81.0% MBSR(BC) group versus 77.4% UC group, p = 0.02), and less number waking bouts (93.5 in MBSR(BC) group versus 118.6 in the UC group, p < 0.01). Small nonsignificant improvements were found in SSP in the MBSR(BC) group from baseline to 6 weeks (PSQI total score, p = 0.09). No significant relationship was observed between minutes of MBSR(BC) practice and SSP or OSP. These data suggest that MBSR(BC) may be an efficacious treatment to improve objective and subjective sleep parameters in BCS. Copyright © 2014 John Wiley & Sons, Ltd.

  9. Small Amounts of Gluten in Subjects With Suspected Nonceliac Gluten Sensitivity: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial.

    Science.gov (United States)

    Di Sabatino, Antonio; Volta, Umberto; Salvatore, Chiara; Biancheri, Paolo; Caio, Giacomo; De Giorgio, Roberto; Di Stefano, Michele; Corazza, Gino R

    2015-09-01

    There is debate over the existence of nonceliac gluten sensitivity (NCGS) intestinal and extraintestinal symptoms in response to ingestion of gluten-containing foods by people without celiac disease or wheat allergy. We performed a randomized, double-blind, placebo-controlled, cross-over trial to determine the effects of administration of low doses of gluten to subjects with suspected NCGS. We enrolled 61 adults without celiac disease or a wheat allergy who believed ingestion of gluten-containing food to be the cause of their intestinal and extraintestinal symptoms. Participants were assigned randomly to groups given either 4.375 g/day gluten or rice starch (placebo) for 1 week, each via gastrosoluble capsules. After a 1-week gluten-free diet, participants crossed over to the other group. The primary outcome was the change in overall (intestinal and extraintestinal) symptoms, determined by established scoring systems, between gluten and placebo intake. A secondary outcome was the change in individual symptom scores between gluten vs placebo. According to the per-protocol analysis of data from the 59 patients who completed the trial, intake of gluten significantly increased overall symptoms compared with placebo (P = .034). Abdominal bloating (P = .040) and pain (P = .047), among the intestinal symptoms, and foggy mind (P = .019), depression (P = .020), and aphthous stomatitis (P = .025), among the extraintestinal symptoms, were significantly more severe when subjects received gluten than placebo. In a cross-over trial of subjects with suspected NCGS, the severity of overall symptoms increased significantly during 1 week of intake of small amounts of gluten, compared with placebo. Clinical trial no: ISRCTN72857280. Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.

  10. The Effects of Mindfulness-Based Stress Reduction (MBSR(BC)) on Objective and Subjective Sleep Parameters in Women with Breast Cancer: A Randomized Controlled Trial

    Science.gov (United States)

    Lengacher, Cecile A.; Reich, Richard R.; Paterson, Carly L.; Jim, Heather S.; Ramesar, Sophia; Alinat, Carissa B.; Budhrani, Pinky H.; Farias, Jerrica R.; Shelton, Melissa M.; Moscoso, Manolete S.; Park, Jong Y.; Kip, Kevin E.

    2014-01-01

    Objective The purpose of this study was to investigate the effects of MBSR(BC) on multiple measures of objective and subjective sleep parameters among breast cancer survivors (BCS). Methods Data were collected using a two-armed randomized controlled design among BCS enrolled in either a six week MBSR(BC) program or a Usual Care (UC) group with a 12-week follow-up. The present analysis is a subset of the larger parent trial (ClinicalTrials.gov Identifier: NCT01177124). Seventy-nine BCS participants (mean age 57 years), stages 0-III, were randomly assigned to either the formal (in-class) six week MBSR(BC) program or UC. Subjective sleep parameters (SSP) (i.e., sleep diaries and the Pittsburg Sleep Quality Index (PSQI)) and objective sleep parameters (OSP) (i.e., actigraphy) were measured at baseline, six weeks and 12 weeks after completing the MBSR(BC) or UC program. Results Results showed indications of a positive effect of MBSR(BC) on OSP at 12 weeks on sleep efficiency (78.2% MBSR(BC) group vs. 74.6% UC group, p=0.04), percent of sleep time (81.0% MBSR(BC) vs. 77.4% UC, p=0.02) and less number waking bouts (93.5 in MBSR(BC) vs. 118.6 in the UC group, pMBSR(BC) group from baseline to 6 weeks (PSQI total score, p=0.09). No significant relationship was observed between minutes of MBSR(BC) practice and SSP or OSP. Conclusions These data suggest that MBSR(BC) may be an efficacious treatment to improve objective and subjective sleep parameters in BCS. PMID:24943918

  11. Noninvasive positive pressure ventilation in subjects with stable COPD: a randomized trial

    Directory of Open Access Journals (Sweden)

    Bhatt SP

    2013-11-01

    Full Text Available Surya P Bhatt,1 Michael W Peterson,2 Jeffrey S Wilson,1 Lakshmi Durairaj1 1Division of Pulmonary, Critical Care, and Occupational Medicine, Department of Internal Medicine, Roy J and Lucille A, Carver College of Medicine, University of Iowa Hospital, Iowa City, IA, USA; 2Department of Medicine, UCSF Fresno Medical Education Program, Fresno, CA, USA Background: The use of domiciliary noninvasive positive pressure ventilation (NPPV in stable chronic obstructive pulmonary disease (COPD with chronic hypercapnic respiratory failure has yielded variable effects on survival, quality of life, and dyspnea. We hypothesized that use of NPPV in stable COPD and partial pressure of carbon dioxide (PaCO2 <52 mmHg might result in improvement in quality of life and dyspnea. Methods: Thirty patients with stable COPD (forced expiratory volume in the first second <50% predicted and PaCO2 <52 mmHg were prospectively randomized to receive domiciliary NPPV (bilevel positive airway pressure, 15/5 cm H2O or usual therapy for 6 months. Measurements were made at baseline, 6 weeks, 3 months, and 6 months. Primary outcomes were quality of life as assessed by the Chronic Respiratory Disease Questionnaire (CRQ, and dyspnea as measured by the Transitional Dyspnea Index (TDI. Results: Fifteen subjects in the NPPV arm and 12 controls completed all the study visits. At 6 weeks and 3 months, the NPPV arm showed significant improvement in TDI total score. However, this effect persisted only in the TDI-Task at 6 months (P=0.03. NPPV use was associated with a small improvement in the CRQ-Mastery domain (0.6 versus –0.1, P=0.04. The arterial partial pressure of oxygen (PaO2 in the control arm worsened over the period of the study, whereas it remained stable in the NPPV arm (change –7.2 mmHg versus +2.1 mmHg, respectively, P=0.02. Conclusion: NPPV resulted in a small improvement in quality of life indices in stable COPD patients with PaCO2 <52 mmHg. Future larger studies will

  12. Randomized placebo controlled trial of furosemide on subjective perception of dyspnoea in patients with pulmonary oedema because of hypertensive crisis.

    Science.gov (United States)

    Holzer-Richling, Nina; Holzer, Michael; Herkner, Harald; Riedmüller, Eva; Havel, Christof; Kaff, Alfred; Malzer, Reinhard; Schreiber, Wolfgang

    2011-06-01

    To compare the administration of furosemide with placebo on the subjective perception of dyspnoea in patients with acute pulmonary oedema because of hypertensive crisis. Design  Randomized, controlled and double-blinded clinical trial. Municipal emergency medical service system and university-based emergency department. Fifty-nine patients with pulmonary oedema because of hypertensive crisis. Additional to administration of oxygen, morphine-hydrochloride and urapidil until the systolic blood pressure was below 160mmHg, the patients were randomized to receive furosemide 80mg IV bolus (furosemide group) or saline placebo (placebo group). The primary outcome was the subjective perception of dyspnoea as measured with a modified BORG scale at one hour after randomization. Secondary outcome parameters were the subjective perception of dyspnoea of patients as measured with a modified BORG scale and a visual analogue scale at 2, 3 and 6h after randomization of the patient; course of the systolic arterial pressure and peripheral oxygen saturation and lactate at admission and at 6h after admission. In 25 patients in the furosemide group and in 28 patients in the placebo group, a BORG score could be obtained. There was no statistically significant difference in the severity of dyspnoea at one hour after randomization (P=0·40). The median BORG score at 1h after randomization in the furosemide group was 3 (IQR 2 to 4) compared to 3 (IQR 2 to 7) in the placebo group (P=0·40). Those patients who were randomized to the placebo group needed higher doses of urapidil at 20min after randomization. There were no significant differences in the rate of adverse events, nonfatal cardiac arrests or death between the two groups. The subjective perception of dyspnoea in patients with hypertensive pulmonary oedema was not influenced by the application of a loop-diuretic. Therefore, additional furosemide therapy needs to be scrutinized in the therapy of these patients. © 2010 The Authors

  13. Efficacy of a novel herbal composition licorice flavonoid oil in subject with metabolic syndrome: a randomized double-blind placebo-controlled clinical study

    Directory of Open Access Journals (Sweden)

    Kaku Nakagawa

    2017-03-01

    Full Text Available Background:In order toevaluate the effects of licorice flavonoid oil (LFOon abdominalwaist circumference, blood pressure, body weight, body mass index (BMI, lipid profile, body fat composition,and fasting blood glucose in patients with metabolic syndrome, a 12 week randomized double-blind placebo-controlledstudywas conducted. Methods: Fiftypatientswith metabolic syndrome agedbetween 18-75 years were assigned toeither the LFO or placebo group. Abdominal waist circumference, blood pressure, body weight,and BMI were assessed atbaseline, week 4, week 8,and week 12. Clinical laboratory examinations, fat composition,andfasting blood glucose level wereassessed at baseline (week 0 and final visit(week 12.Results: Atotal of 50 subjects (25 subjects in each groupcompleted the 12-weekstudy. Significant difference inchangesfrom the baseline wasobserved in body weight, waist circumference,and BMI in the LFOgroup compared to the placebo group from week 4or week 8 onwards. No adverse events were noted throughout the study. Conclusion: The present study suggeststhat LFOisa promising dietary nutrient forimproving metabolic syndrome, particularlythroughits beneficial effect of normalizingbody weight, BMI,and possibly the amount of visceral fatand HDL cholesterol.

  14. Analysis of 2-Week Data from Two Randomized, Controlled Trials Conducted in Subjects with Frequent Heartburn Treated with Esomeprazole 20 mg.

    Science.gov (United States)

    Katz, Philip O; Le Moigne, Anne; Pollack, Charles

    2017-05-01

    These secondary analyses used data from 2 similarly designed studies in subjects experiencing frequent heartburn to evaluate the efficacy of esomeprazole 20 mg once daily for 2 weeks, which reflects the approved over-the-counter dosage and duration. Subjects without endoscopically identified erosive esophagitis who were experiencing heartburn for ≥6 months and ≥4 of 7 days prior to baseline (study 1, N = 368; study 2, N = 349) were randomly assigned to receive double-blind treatment with esomeprazole 40 or 20 mg (administered as esomeprazole magnesium trihydrate 44.5 and 22.3 mg, respectively) or placebo once daily for 4 weeks. Subjects recorded the severity of heartburn in a daily diary, and investigators assessed subjects at each study visit. Two-week assessments were the primary end points of interest in these analyses and included the percentage of subjects with complete heartburn resolution (no episodes during 7 consecutive days), time to sustained complete heartburn resolution (the first of 7 consecutive episode-free days), and heartburn relief (no episodes other than ≤1 mild episode during 7 consecutive days). At week 2, the percentages of subjects who experienced complete heartburn resolution were significantly greater with esomeprazole 40 mg (study 1, 26.1%; study 2, 35.3%) and 20 mg (study 1, 25.2%; study 2, 35.7%) compared with placebo (study 1, 9.0%; study 2, 3.4%) (all, P ≤ 0.001). Beginning on day 1, the percentages of subjects who experienced sustained heartburn resolution was significantly greater in the groups treated with esomeprazole 40 mg (study 1, 19%; study 2, 19%; P esomeprazole 40 mg (study 1, 35.3%; study 2, 40.5%) and 20 mg (study 1, 34.5%; study 2, 46.4%) compared with placebo (study 1, 16.5%; study 2, 8.6%) (all, P ≤ 0.001). The results of this study demonstrate that once-daily treatment with esomeprazole 20 mg for 2 weeks effectively resolved subjects׳ heartburn compared with placebo, beginning on day 1. Studies precede FDA

  15. A randomized, controlled study of specific immunotherapy in monosensitized subjects with seasonal rhinitis: effect on bronchial hyperresponsiveness, sputum inflammatory markers and development of asthma symptoms.

    Science.gov (United States)

    Crimi, Nunzio; Li Gotti, Fabrizio; Mangano, Giuseppe; Paolino, Giuseppina; Mastruzzo, Claudio; Vancheri, Carlo; Lisitano, Natalina; Polosa, Riccardo

    2004-01-01

    Allergic rhinitis is often associated with bronchial hyperresponsiveness (BHR) and airway inflammation, and it seems to be an important risk factor for the development of asthma. Specific immunotherapy (SIT) reduces symptoms and medication requirements in subjects with allergic rhinitis, but the mechanisms by which SIT promotes these beneficial effects are less clear. We have investigated the effects of Parietaria-SIT on rhinitis symptoms, BHR to inhaled methacholine, eosinophilic inflammation and cytokine production (interferon gamma and interleukin-4) in the sputum. The effect on asthma progression was also examined. Thirty non-asthmatic subjects with seasonal rhinitis and monosensitized to Parietaria judaica participated in a randomized, double-blind, placebo-controlled, parallel group study. Participants were randomly assigned to receive injections of a Parietaria pollen vaccine (n = 15) or matched placebo injections (n = 15) in a rapid updosing cluster regimen for 7 weeks, followed by monthly injections for 34 months. Throughout the 3-year study we collected data on symptoms and medication score, airway responsiveness to methacholine, eosinophilia and soluble cytokines in sputum, followed by a complete evaluation of the clinical course of atopy. Hay fever symptom and medication scores were well controlled by SIT. By the end of the study, in the placebo group, symptom and medication scores significantly increased by a median (interquartile range) of 121% (15-280%) and 263% (0-4400%) respectively (p Parietaria-SIT is effective in controlling hay fever symptoms and rescue medications, but no changes in the BHR to methacholine or sputum eosinophilia were observed. Moreover, Parietaria-SIT appears to prevent the natural progression of allergic rhinitis to asthma, suggesting that SIT should be considered earlier in the management of this condition.

  16. Effect of phytosterols and inulin-enriched soymilk on LDL-cholesterol in Thai subjects: a double-blinded randomized controlled trial.

    Science.gov (United States)

    Kietsiriroje, Noppadol; Kwankaew, Jirateep; Kitpakornsanti, Sunita; Leelawattana, Rattana

    2015-11-09

    Hypercholesterolemia, particularly high LDL-c and non-HDL-c levels, is a traditional risk for cardiovascular disease. Ingestion of diets containing phytosterols and inulin can reduce plasma LDL-c and triglyceride levels, respectively. Phytosterols and inulin-enriched soymilk may be an alternative for a supplemental diet to improve both LDL-c and non-HDL-c to reduce the risk of cardiovascular disease. Two hundred and forty subjects who were 18 years old or older and had a baseline LDL-c of 130 mg/dl or higher were enrolled into the double-blinded randomized controlled trial study. Subjects were randomly assigned into the study group that received 2 g/day of phytosterols and 10 g/day of inulin-enriched soymilk or into the control group that received standard soymilk. The lipid profile was measured every 2 weeks for 8 weeks. Primary outcomes were 1) to determine the LDL-c reduction after consumption of phytosterols and inulin-enriched soymilk for 8 weeks and 2) to compare the difference of the LDL-c levels between the study and control groups. The secondary outcomes were to compare the difference of TC, TG and HDL-c between the study and control groups. At the end of the study, the median LDL-c levels decreased significantly from 165 (132, 254) mg/dl to 150 (105, 263) mg/dl in the study group (p inulin reduced TC and LDL-c better than standard soymilk. It had no effect on TG and HDL-c levels compared to standard soymilk. Both soymilk products were comparably safe. Thai Clinical Trial Registry: TCTR20150417001 date: April 17, 2015.

  17. A Preliminary Investigation of Individual Differences in Subjective Responses to D-Amphetamine, Alcohol, and Delta-9-Tetrahydrocannabinol Using a Within-Subjects Randomized Trial.

    Directory of Open Access Journals (Sweden)

    Margaret C Wardle

    Full Text Available Polydrug use is common, and might occur because certain individuals experience positive effects from several different drugs during early stages of use. This study examined individual differences in subjective responses to single oral doses of d-amphetamine, alcohol, and delta-9-tetrahydrocannabinol (THC in healthy social drinkers. Each of these drugs produces feelings of well-being in at least some individuals, and we hypothesized that subjective responses to these drugs would be positively correlated. We also examined participants' drug responses in relation to personality traits associated with drug use. In this initial, exploratory study, 24 healthy, light drug users (12 male, 12 female, aged 21-31 years, participated in a fully within-subject, randomized, counterbalanced design with six 5.5-hour sessions in which they received d-amphetamine (20mg, alcohol (0.8 g/kg, or THC (7.5 mg, each paired with a placebo session. Participants rated the drugs' effects on both global measures (e.g. feeling a drug effect at all and drug-specific measures. In general, participants' responses to the three drugs were unrelated. Unexpectedly, "wanting more" alcohol was inversely correlated with "wanting more" THC. Additionally, in women, but not in men, "disliking" alcohol was negatively correlated with "disliking" THC. Positive alcohol and amphetamine responses were related, but only in individuals who experienced a stimulant effect of alcohol. Finally, high trait constraint (or lack of impulsivity was associated with lower reports of liking alcohol. No personality traits predicted responses across multiple drug types. Generally, these findings do not support the idea that certain individuals experience greater positive effects across multiple drug classes, but instead provide some evidence for a "drug of choice" model, in which individuals respond positively to certain classes of drugs that share similar subjective effects, and dislike other types

  18. Safety and tolerability of intravenous regadenoson in healthy subjects: A randomized, repeat-dose, placebo-controlled study.

    Science.gov (United States)

    Townsend, Robert; Desai, Amit; Rammelsberg, Diane; Kowalski, Donna; Simmons, Neal; Kitt, Therese M

    2017-02-01

    Regadenoson is a selective A 2A adenosine receptor agonist indicated for radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. However, the safety, tolerability, and plasma concentrations associated with repeated doses have not previously been assessed. Healthy males and females were randomized to receive intravenous regadenoson [100 μg (3 doses), 200 μg (3 doses), or 400 μg (2 doses)], or placebo (2 or 3 doses; 0.9% sodium chloride); all doses 10 minutes apart. The primary endpoint was vital sign measurements (blood pressure and heart rate). Secondary endpoints included 12-lead electrocardiogram measurements, clinical laboratory evaluations (hematology, chemistry, and urinalysis), and adverse events. Thirty-six subjects were randomized and completed the study. Plasma concentrations of regadenoson increased in a dose-related manner and with successive doses. No consistent effect was observed for systolic blood pressure, although diastolic blood pressure was slightly lower than placebo for all regadenoson groups. Transient, dose-dependent increases in heart rate were observed in all regadenoson groups. There were no serious adverse events; 27 adverse events occurred in 14 regadenoson-treated subjects vs two events in two placebo-treated subjects. Repeated doses of regadenoson appeared to be safe and well tolerated in healthy subjects.

  19. Size-dependent piezoelectric energy-harvesting analysis of micro/nano bridges subjected to random ambient excitations

    Science.gov (United States)

    Radgolchin, Moeen; Moeenfard, Hamid

    2018-02-01

    The construction of self-powered micro-electro-mechanical units by converting the mechanical energy of the systems into electrical power has attracted much attention in recent years. While power harvesting from deterministic external excitations is state of the art, it has been much more difficult to derive mathematical models for scavenging electrical energy from ambient random vibrations, due to the stochastic nature of the excitations. The current research concerns analytical modeling of micro-bridge energy harvesters based on random vibration theory. Since classical elasticity fails to accurately predict the mechanical behavior of micro-structures, strain gradient theory is employed as a powerful tool to increase the accuracy of the random vibration modeling of the micro-harvester. Equations of motion of the system in the time domain are derived using the Lagrange approach. These are then utilized to determine the frequency and impulse responses of the structure. Assuming the energy harvester to be subjected to a combination of broadband and limited-band random support motion and transverse loading, closed-form expressions for mean, mean square, correlation and spectral density of the output power are derived. The suggested formulation is further exploited to investigate the effect of the different design parameters, including the geometric properties of the structure as well as the properties of the electrical circuit on the resulting power. Furthermore, the effect of length scale parameters on the harvested energy is investigated in detail. It is observed that the predictions of classical and even simple size-dependent theories (such as couple stress) appreciably differ from the findings of strain gradient theory on the basis of random vibration. This study presents a first-time modeling of micro-scale harvesters under stochastic excitations using a size-dependent approach and can be considered as a reliable foundation for future research in the field of

  20. Assigning agents to a line

    DEFF Research Database (Denmark)

    Hougaard, Jens Leth; Moreno-Ternero, Juan D.; Østerdal, Lars Peter Raahave

    2014-01-01

    minimizing modification of the classic random priority method to solve this class of problems. We also provide some logical relations in our setting among standard axioms in the literature on assignment problems, and explore the robustness of our results to several extensions of our setting....

  1. Outcomes are not different for patient-matched vs. non-matched treatment in subjects with chronic, recurrent low back pain: a randomized clinical trial

    Science.gov (United States)

    Henry, Sharon M.; Van Dillen, Linda; Ouellette-Morton, Rebecca H.; Hitt, Juvena R.; Lomond, Karen V.; DeSarno, Michael J.; Bunn, Janice Y.

    2014-01-01

    Background Classification schemas for low back pain (LBP), such as the Treatment Based Classification and the Movement System Impairment schemas, use common clinical features to subgroup patients with LBP and are purported to improve treatment outcomes. Purpose To assess if providing matched treatments based on patient specific clinical features led to superior treatment outcomes compared to an unmatched treatment for subjects with chronic, recurrent LBP. Study Design A randomized controlled trial. Patient Sample Subjects (n=124) with LBP (≥ 12 months) with or without recurrences underwent a standardized clinical exam to group them into one of 2 strata: (1) ineligible or (2) eligible for stabilization exercises based on the Treatment Based Classification schema. Subjects underwent additional clinical tests to assign them to one of the 5 possible Movement System Impairment categories. Outcome Measures Questionnaires were collected electronically at: Week 0, prior to treatment; Week 7 (following the 6 weekly, one hour treatment sessions); and 12 months. Using the Oswestry Disability Index (0-100) and the Numeric Pain Rating Scale (0-10), the primary analysis was performed using the intention-to-treat principle. Secondary outcomes included fear-avoidance beliefs as well as psychosocial, work related and general health status. Methods After subjects were categorized based on their particular clinical features using both the Treatment Based Classification and Movement System Impairment schemas, they were randomized into one of two treatments using a 3:1 ratio for matched or unmatched treatments. The treatments were (1) trunk stabilization exercise, or (2) Movement System Impairment-directed exercises. The study was funded by National Institutes of Health (NCMRR/R01HD040909; $1,485,000). There are no study specific conflicts of interest to report. Results Of the patients allocated to treatment for this study, 76 received a matched treatment and 25 received an unmatched

  2. Spencer-Brown vs. Probability and Statistics: Entropy’s Testimony on Subjective and Objective Randomness

    Directory of Open Access Journals (Sweden)

    Julio Michael Stern

    2011-04-01

    Full Text Available This article analyzes the role of entropy in Bayesian statistics, focusing on its use as a tool for detection, recognition and validation of eigen-solutions. “Objects as eigen-solutions” is a key metaphor of the cognitive constructivism epistemological framework developed by the philosopher Heinz von Foerster. Special attention is given to some objections to the concepts of probability, statistics and randomization posed by George Spencer-Brown, a figure of great influence in the field of radical constructivism.

  3. Assignment refusal and its relation to outcome in a randomized controlled trial comparing Cognitive Therapy and Fluvoxamine in treatment-resistant patients with obsessive compulsive disorder

    NARCIS (Netherlands)

    Landsheer, J.A.; Smit, J.H.; van Oppen, P.C.; van Balkom, A.J.L.M.

    2015-01-01

    The effectiveness of Fluvoxamine was compared to that of Cognitive Therapy (CT) in a 12-week randomized controlled trial (RCT) in 48 patients with obsessive-compulsive disorder (OCD), who were treatment-resistant to a previous behavior therapy (BT). A considerable amount of patients did not comply

  4. A whey-protein supplement increases fat loss and spares lean muscle in obese subjects: a randomized human clinical study

    Directory of Open Access Journals (Sweden)

    Ward Loren S

    2008-03-01

    Full Text Available Abstract Background This study evaluated a specialized whey fraction (Prolibra™, high in leucine, bioactive peptides and milk calcium for use as a dietary supplement to enhance weight loss. Methods This was a randomized, double-blind, parallel-arm, 12-week study. Caloric intake was reduced 500 calories per day. Subjects consumed Prolibra or an isocaloric ready-to-mix beverage 20 minutes before breakfast and 20 minutes before dinner. Body fat and lean muscle tissue were measured by dual-energy x-ray absorptiometry (DEXA. Body weight and anthropometric measurements were recorded every 4 weeks. Blood samples were taken at the beginning and end of the study. Statistical analyses were performed on all subjects that completed (completer analysis and all subjects that lost at least 2.25 kg of body weight (responder analysis. Within group significance was determined at P Results Both groups lost a significant amount of weight and the Prolibra group tended to lose more weight than the control group; however the amount of weight loss was not significantly different between groups after 12 weeks. Prolibra subjects lost significantly more body fat compared to control subjects for both the completer (2.81 vs. 1.62 kg P = 0.03 and responder (3.63 vs. 2.11 kg, P = 0.01 groups. Prolibra subjects lost significantly less lean muscle mass in the responder group (1.07 vs. 2.41 kg, P = 0.02. The ratio of fat to lean loss (kg fat lost/kg lean lost was much larger for Prolibra subjects for both completer (3.75 vs. 1.05 and responder (3.39 vs. 0.88 groups. Conclusion Subjects in both the control and treatment group lost a significant amount of weight with a 500 calorie reduced diet. Subjects taking Prolibra lost significantly more body fat and showed a greater preservation of lean muscle compared to subjects consuming the control beverage. Because subjects taking Prolibra lost 6.1% of their body fat mass, and because a 5% reduction of body fat mass has been shown to

  5. Extracorporeal shock wave therapy in patients with plantar fasciitis. A randomized, placebo-controlled trial with ultrasonographic and subjective outcome assessments

    Science.gov (United States)

    Vahdatpour, Babak; Sajadieh, Sepideh; Bateni, Vahid; Karami, Mehdi; Sajjadieh, Hamidreza

    2012-01-01

    Background and Aim: Results of previous studies have been conflicting on the efficacy of extracorporeal shock wave therapy (ESWT) in the treatment of plantar fasciitis. We evaluated the effects of ESWT on plantar fasciitis in terms of ultrasonographic and subjective evaluations. Materials and Methods: In this randomized placebo-controlled trial, patients with plantar fasciitis were assigned to receive ESWT (4000 shock waves/session of 0.2 mJ/mm2) in 3 sessions at weekly intervals) or sham therapy (n = 20 in each group). Outcomes were documented by the ultrasonographic appearance of the aponeurosis and by patients’ pain scores, performed at baseline and 12 weeks after completion of the therapy. Results: The two groups were similar in baseline characteristics. Over the study period, plantar fascia thickness significantly reduced in the ESWT group (4.1 ± 1.3 to 3.6 ± 1.2 mm, P plantar fasciitis and ultrasound imaging is able to depict the morphologic changes related to plantar fasciitis as a result of this therapy. PMID:23826009

  6. A phase 1, randomized ascending single-dose study of antagonist anti-human CD40 ASKP1240 in healthy subjects.

    Science.gov (United States)

    Goldwater, R; Keirns, J; Blahunka, P; First, R; Sawamoto, T; Zhang, W; Kowalski, D; Kaibara, A; Holman, J

    2013-04-01

    This first-in-human, phase I study evaluated the safety, tolerability, pharmacokinetic and pharmacodynamic profile of ASKP1240 in healthy subjects. Twelve sequential groups (each 6 active and 3 placebo) were randomly assigned to placebo or single ascending doses of intravenous ASKP1240 (0.00003-10 mg/kg). ASKP1240 exhibited nonlinear pharmacokinetics, with mean maximal serum concentrations and area under the serum concentration-time curves ranging from 0.7 to 251.6 μg/mL and 6.5 to 55409.6 h·μg/mL following doses 0.1 mg/kg-10 mg/kg, respectively. CD40 receptor occupancy by ASKP1240, which was dose-dependent, reached a maximum at doses above 0.01 mg/kg. ASKP1240 was well tolerated, with no evidence of cytokine release syndrome or thromboembolic events. Treatment emergent antibodies to ASKP1240 were detected in 5/70 (7.1%) ASKP1240 recipients. In conclusion, antagonism of the CD40/CD154 interaction with ASKP1240 was safe and well tolerated at the doses tested. © Copyright 2013 The American Society of Transplantation and the American Society of Transplant Surgeons.

  7. Beneficial Effects of Pterocarpan-High Soybean Leaf Extract on Metabolic Syndrome in Overweight and Obese Korean Subjects: Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Ri Ryu

    2016-11-01

    Full Text Available Pterocarpans are known to have antifungal and anti-inflammatory properties. However, little is known about the changes in transcriptional profiles in response to a pterocarpan-high soybean leaf extract (PT. Therefore, this study investigated the effects of PT on blood glucose and lipid levels, as well as on the inflammation-related gene expression based on a peripheral blood mononuclear cells (PBMCs mRNA sequencing analysis in Korean overweight and obese subjects with mild metabolic syndrome. The participants were randomly assigned to two groups and were administered either placebo (starch, 3 g/day or PT (2 g/day for 12 weeks. The PT intervention did not change body weight, body fat percentage and body mass index (BMI. However, PT significantly decreased the glycosylated hemoglobin (HbA1c, plasma glucose, free fatty acid, total cholesterol, and non-HDL cholesterol levels after 12 weeks. Furthermore, PT supplementation significantly lowered the homeostatic index of insulin resistance, as well as the plasma levels of inflammatory markers. Finally, the mRNA sequencing analysis revealed that PT downregulated genes related to immune responses. PT supplementation is beneficial for the improvement of metabolic syndrome by altering the fasting blood and plasma glucose, HbA1c, plasma lipid levels and inflammation-related gene expression in PBMCs.

  8. Beneficial Effects of Pterocarpan-High Soybean Leaf Extract on Metabolic Syndrome in Overweight and Obese Korean Subjects: Randomized Controlled Trial.

    Science.gov (United States)

    Ryu, Ri; Jeong, Tae-Sook; Kim, Ye Jin; Choi, Ji-Young; Cho, Su-Jung; Kwon, Eun-Young; Jung, Un Ju; Ji, Hyeon-Seon; Shin, Dong-Ha; Choi, Myung-Sook

    2016-11-18

    Pterocarpans are known to have antifungal and anti-inflammatory properties. However, little is known about the changes in transcriptional profiles in response to a pterocarpan-high soybean leaf extract (PT). Therefore, this study investigated the effects of PT on blood glucose and lipid levels, as well as on the inflammation-related gene expression based on a peripheral blood mononuclear cells (PBMCs) mRNA sequencing analysis in Korean overweight and obese subjects with mild metabolic syndrome. The participants were randomly assigned to two groups and were administered either placebo (starch, 3 g/day) or PT (2 g/day) for 12 weeks. The PT intervention did not change body weight, body fat percentage and body mass index (BMI). However, PT significantly decreased the glycosylated hemoglobin (HbA1c), plasma glucose, free fatty acid, total cholesterol, and non-HDL cholesterol levels after 12 weeks. Furthermore, PT supplementation significantly lowered the homeostatic index of insulin resistance, as well as the plasma levels of inflammatory markers. Finally, the mRNA sequencing analysis revealed that PT downregulated genes related to immune responses. PT supplementation is beneficial for the improvement of metabolic syndrome by altering the fasting blood and plasma glucose, HbA1c, plasma lipid levels and inflammation-related gene expression in PBMCs.

  9. Randomized pharmacokinetic and drug-drug interaction studies of ceftazidime, avibactam, and metronidazole in healthy subjects.

    Science.gov (United States)

    Das, Shampa; Li, Jianguo; Armstrong, Jon; Learoyd, Maria; Edeki, Timi

    2015-10-01

    We assessed pharmacokinetic and safety profiles of ceftazidime-avibactam administered ± metronidazole, and whether drug-drug interactions exist between ceftazidime and avibactam, or ceftazidime-avibactam and metronidazole. The first study (NCT01430910) involved two cohorts of healthy subjects. Cohort 1 received ceftazidime-avibactam (2000-500 mg) as a single infusion or as multiple intravenous infusions over 11 days to evaluate ceftazidime-avibactam pharmacokinetics. Cohort 2 received ceftazidime, avibactam, or ceftazidime-avibactam over 4 days to assess drug-drug interaction between ceftazidime and avibactam. The second study (NCT01534247) assessed interaction between ceftazidime-avibactam and metronidazole in subjects receiving ceftazidime-avibactam (2000-500 mg), metronidazole (500 mg), or metronidazole followed by ceftazidime-avibactam over 4 days. In all studies, subjects received a single-dose on the first and final days, and multiple-doses every 8 h on intervening days. Concentration-time profiles for ceftazidime and avibactam administered as single- or multiple-doses separately or together with/without metronidazole were similar. There was no evidence of time-dependent pharmacokinetics or accumulation. In both interaction studies, 90% confidence intervals for geometric least squares mean ratios of area under the curve and maximum plasma concentrations for each drug were within the predefined interval (80-125%) indicating no drug-drug interaction between ceftazidime and avibactam, or ceftazidime-avibactam and metronidazole. There were no safety concerns. In conclusion, pharmacokinetic parameters and safety of ceftazidime, avibactam, and metronidazole were similar after single and multiple doses with no observed drug-drug interaction between ceftazidime and avibactam, or ceftazidime-avibactam and metronidazole.

  10. Randomized pharmacokinetic and drug–drug interaction studies of ceftazidime, avibactam, and metronidazole in healthy subjects

    Science.gov (United States)

    Das, Shampa; Li, Jianguo; Armstrong, Jon; Learoyd, Maria; Edeki, Timi

    2015-01-01

    We assessed pharmacokinetic and safety profiles of ceftazidime–avibactam administered ± metronidazole, and whether drug–drug interactions exist between ceftazidime and avibactam, or ceftazidime-avibactam and metronidazole. The first study (NCT01430910) involved two cohorts of healthy subjects. Cohort 1 received ceftazidime–avibactam (2000–500 mg) as a single infusion or as multiple intravenous infusions over 11 days to evaluate ceftazidime–avibactam pharmacokinetics. Cohort 2 received ceftazidime, avibactam, or ceftazidime–avibactam over 4 days to assess drug–drug interaction between ceftazidime and avibactam. The second study (NCT01534247) assessed interaction between ceftazidime–avibactam and metronidazole in subjects receiving ceftazidime–avibactam (2000–500 mg), metronidazole (500 mg), or metronidazole followed by ceftazidime–avibactam over 4 days. In all studies, subjects received a single-dose on the first and final days, and multiple-doses every 8 h on intervening days. Concentration-time profiles for ceftazidime and avibactam administered as single- or multiple-doses separately or together with/without metronidazole were similar. There was no evidence of time-dependent pharmacokinetics or accumulation. In both interaction studies, 90% confidence intervals for geometric least squares mean ratios of area under the curve and maximum plasma concentrations for each drug were within the predefined interval (80–125%) indicating no drug–drug interaction between ceftazidime and avibactam, or ceftazidime–avibactam and metronidazole. There were no safety concerns. In conclusion, pharmacokinetic parameters and safety of ceftazidime, avibactam, and metronidazole were similar after single and multiple doses with no observed drug–drug interaction between ceftazidime and avibactam, or ceftazidime–avibactam and metronidazole. PMID:26516584

  11. A finite element large deflection random response analysis of beams and plates subjected to acoustic loading

    Science.gov (United States)

    Mei, Chuh; Chiang, C. K.

    1987-01-01

    A finite element formulation is presented for the analysis of beams and rectangular plates undergoing large deflections subjected to Gaussian white noise excitations. Single-mode response is assumed in the present formulation. Root-mean-square (RMS) maximum deflections for simply supported and clamped beams and plates at various sound spectrum levels are obtained and compared with solutions using the Fokker-Planck-Kolmogorov equation and the equivalent linearization methods. RMS maximum stains and equivalent linear frequencies are compared with the equivalent linearization results for assessment of the accuracy of the finite element method.

  12. Random lock-in intervals for tubular structural elements subject to simulated natural wind

    DEFF Research Database (Denmark)

    Christensen, Claus F.; Ditlevsen, Ove Dalager

    1999-01-01

    The paper reports on wind tunnel experiments with an elastically suspended circular cylinder vibrating under the excitation of natural wind of high turbulence degree. The natural wind turbulence was simulated bysuperposing the low frequency part of the natural wind turbulence on the background high...... structural elements subject to thenatural wind. The engineering relevance of the investigation is supported by comparing with the unrealistic highlyconservative rules of wind induced fatique commonly given in codes of practice. The stochastic lock-in model aswell as the related fatigue calculation procedure...

  13. 75 FR 55352 - Delegation of Authorities and Assignment of Responsibilities

    Science.gov (United States)

    2010-09-10

    ... of the Secretary Delegation of Authorities and Assignment of Responsibilities Secretary's Order 5-2010 Subject: Delegation of Authorities and Assignment of Responsibilities to the Administrator, Wage and Hour Division. 1. Purpose. To delegate authorities and assign responsibilities to the...

  14. Energy harvesting in a quad-stable harvester subjected to random excitation

    Directory of Open Access Journals (Sweden)

    Zhi-yong Zhou

    2016-02-01

    Full Text Available In response to the defects of bi-stable energy harvester (BEH, we develop a novel quad-stable energy harvester (QEH to improve harvesting efficiency. The device is made up of a bimorph cantilever beam having a tip magnet and three external fixed magnets. By adjusting the positions of the fixed magnets and the distances between the tip magnet and the fixed ones, the quad-stable equilibrium positions can emerge. The potential energy shows that the barriers of the QEH are lower than those of the BEH for the same separation distance. Experiment results reveal that the QEH can realize snap-through easier and make a dense snap-through in response under random excitation. Moreover, its strain and voltage both become large for snap-through between the nonadjacent stable positions. There exists an optimal separation distance for different excitation intensities.

  15. A randomized controlled trial of two simple mind-body programs, Kirtan Kriya meditation and music listening, for adults with subjective cognitive decline: Feasibility and acceptability.

    Science.gov (United States)

    Innes, Kim E; Selfe, Terry Kit; Khalsa, Dharma Singh; Kandati, Sahiti

    2016-06-01

    In this randomized controlled trial (RCT), we assessed the feasibility and acceptability of two simple home-based relaxation programs in adults experiencing subjective cognitive decline, a strong predictor of Alzheimer's disease. Sixty participants were randomized to a beginner Kirtan Kriya meditation (KK) program or a music listening (ML) program. Participants were asked to practice 12min daily for the first 12 weeks, then as often as they liked for the following 3 months. Participants underwent assessments at baseline, 12 weeks, and 6 months to evaluate changes in key outcomes. Feasibility and acceptability were evaluated by measuring recruitment and retention rates, assessment visit attendance, practice adherence, and treatment expectancy; exit questionnaires completed at 12 weeks and 6 months provided additional data regarding participant experience with the study, perceived barriers to and facilitators of practice, reasons for drop-out, and views regarding the assigned intervention. Fifty-three participants (88%) completed the 6 month study. Adherence in both groups was excellent, with participants completing 93% (91% KK, 94% ML) of sessions on average in the first 12 weeks, and 71% (68% KK, 74% ML) during the 3 month, practice-optional, follow-up period. At week 12, over 80% of participants indicated they were likely to continue practicing following study completion. Responses to both structured and open-ended exit questionnaire items also suggested high satisfaction with both programs. Findings of this RCT of a beginner meditation practice and a simple ML program suggest that both programs were well accepted and the practices are feasible in adults with early memory loss. Copyright © 2016 Elsevier Ltd. All rights reserved.

  16. A randomized double blind study of a green and black tea agent, AssuriTEA®, in healthy male subjects

    Directory of Open Access Journals (Sweden)

    Jillian Capodice

    2015-10-01

    Full Text Available Background: Green and black teas have known anti-oxidant and anti-inflammatory properties. The current study was a prospective randomized, double-blind, placebo controlled study of 3 doses of a water-extracted green and black tea agent (AssuriTEA® [AT]. Methods: Subjects who met inclusion criteria were randomized to one of four groups: 1000, 500, or 250 mg AT or placebo for 28 days. At baseline (BL and day 28, serum antioxidant capacity, quality of life and safety were assessed. Results: Of the 55 subjects screened, 43 were considered evaluable. Age was 56.77 ± 2.83 years (mean ± SEM. Evaluable subjects demonstrated improved antioxidant status, as measured by ferric iron reducing antioxidant power at all doses over the placebo (p < 0.05. There was significant improvement in cellular antioxidant protection in the 1000 mg AT group versus the placebo (p=0.032. Glucose levels were higher in the placebo group versus the 250 mg AT group (p=0.023 and there was a significant improvement in systolic blood pressure in the 250 mg AT group at day 28 versus BL (p=0.048. In the 1000 mg AT group, there was a significant decrease in systolic blood pressure at day 28 versus BL (p=0.017. There was a significant improvement in the vitality category in the 1000 mg AT group (p=0.029. Overall, AT was safe and well tolerated with no differences in adverse events or serum chemistries between groups. Conclusions: Results demonstrate that the administration of AT resulted in improvement of serum antioxidant status, vitality level, blood glucose, and systolic blood pressure in test subjects.

  17. Absolute Bioavailability of Bosutinib in Healthy Subjects From an Open-Label, Randomized, 2-Period Crossover Study.

    Science.gov (United States)

    Hsyu, Poe-Hirr; Pignataro, Daniela Soriano; Matschke, Kyle

    2017-10-23

    This study evaluated the absolute bioavailability of bosutinib and assessed its safety and tolerability after single-dose oral and intravenous administration. In this phase 1 open-label, 2-sequence, 2-period crossover study, healthy, fed subjects aged 18-55 years were randomized to 1 of 2 treatment sequences (n = 7/sequence): oral bosutinib (100 mg × 5) followed by intravenous bosutinib (120 mg in approximately 240 mL over 1 hour), with a ≥14-day washout, or intravenous bosutinib and then oral bosutinib. Results of plasma pharmacokinetics analyses demonstrated that exposure to intravenous bosutinib was 3-fold higher than for oral bosutinib (16.2 and 5.5 ng·h/mL/mg, respectively), and mean terminal half-life was similar (35.5 and 31.7 hours). The ratio of adjusted geometric means (90%CI) for the dose-normalized area under the plasma concentration-time profile (AUC0-∞ /D) was 33.85% (30.65%-37.38%). Most treatment-emergent adverse events (AEs) were mild in severity. Gastrointestinal (GI) AEs occurred in 9 of 13 subjects given oral bosutinib, whereas no subjects given intravenous bosutinib experienced GI AEs, suggesting bosutinib present in the GI tract had an effect. Bosutinib exhibited an absolute bioavailability of 33.85% based on the ratio of AUC0-∞ /D. Both oral and intravenous bosutinib were safe and well tolerated in healthy, fed adult subjects. © 2017, The American College of Clinical Pharmacology.

  18. Large Intra-subject Variability in Caffeine Pharmacokinetics: Randomized Cross-over Study of Single Caffeine Product.

    Science.gov (United States)

    Hammami, Muhammad M; Alvi, Syed N

    2017-09-01

    Background Average bioequivalence has been criticized for not adequately addressing individual variations. Importance of subjects' blinding in bioequivalence studies has not been well studied. We explored the extent of intra-subject pharmacokinetic variability and effect of drug-ingestion unawareness in subjects taking single caffeine product. Methods A single-dose randomized cross-over design was used to compare pharmacokinetics of 200 mg caffeine, described as caffeine (overt) or as placebo (covert). Maximum concentration (Cmax), Cmax first time (Tmax), area-under-the-concentration-time-curve, to last measured concentration (AUCT), extrapolated to infinity (AUCI), or to Tmax of overt caffeine (AUCOverttmax), and Cmax/AUCI were calculated blindly using standard non-compartmental method. Percentages of individual covert/overt ratios that are outside the ±25% range were determined. Covert-vs-overt effect on caffeine pharmacokinetics was evaluated by 90% confidence interval (CI) and 80.00-125.00% bioequivalence range. Results 32 healthy subjects (6% females, mean (SD) age 33.3 (7.2) year) participated in the study (28 analysed). Out of the 28 individual covert/overt ratios, 23% were outside the ±25% range for AUCT, 30% for AUCI, 20% for AUCOverttmax, 30% for Cmax, and 43% for Tmax. There was no significant covert-vs-overt difference in any of the pharmacokinetic parameters studied. Further, the 90% CIs for AUCT, AUCI, Cmax, AUCOverttmax, and Cmax/AUCI were all within the 80.00-125.00% bioequivalence range with mean absolute deviation of covert/overt ratios of 3.31%, 6.29%, 1.43%, 1.87%, and 5.19%, respectively. Conclusions Large intra-subject variability in main caffeine pharmacokinetic parameters was noted when comparing an oral caffeine product to itself. Subjects' blinding may not be important in average bioequivalence studies. © Georg Thieme Verlag KG Stuttgart · New York.

  19. First-In-Human, Double-Blind, Placebo-Controlled, Randomized, Dose-Escalation Study of BG00010, a Glial Cell Line-Derived Neurotrophic Factor Family Member, in Subjects with Unilateral Sciatica.

    Science.gov (United States)

    Rolan, Paul E; O'Neill, Gilmore; Versage, Eve; Rana, Jitesh; Tang, Yongqiang; Galluppi, Gerald; Aycardi, Ernesto

    2015-01-01

    To evaluate the safety, tolerability, and pharmacokinetics of single doses of BG00010 (neublastin, artemin, enovin) in subjects with unilateral sciatica. This was a single-center, blinded, placebo-controlled, randomized Phase 1 sequential-cohort, dose-escalation study (ClinicalTrials.gov identifier NCT00961766; funded by Biogen Idec). Adults with unilateral sciatica were enrolled at The Royal Adelaide Hospital, Australia. Four subjects were assigned to each of eleven cohorts (intravenous BG00010 0.3, 1, 3, 10, 25, 50, 100, 200, 400, or 800 μg/kg, or subcutaneous BG00010 50 μg/kg) and were randomized 3:1 to receive a single dose of BG00010 or placebo. The primary safety and tolerability assessments were: adverse events; clinical laboratory parameters and vital signs; pain as measured by a Likert rating scale; intra-epidermal nerve fiber density; and longitudinal assessment of quantitative sensory test parameters. Blood, serum, and plasma samples were collected for pharmacokinetic and pharmacodynamic assessments. Subjects were blinded to treatment assignment throughout the study. The investigator was blinded to treatment assignment until the Data Safety Review Committee review of unblinded data, which occurred after day 28. Beyond the planned enrollment of 44 subjects, four additional subjects were enrolled into to the intravenous BG00010 200 μg/kg cohort after one original subject experienced mild generalized pruritus. Therefore, a total of 48 subjects were enrolled between August 2009 and December 2011; all were included in the safety analyses. BG00010 was generally well tolerated: in primary analyses, the most common treatment-emergent adverse events were changes in temperature perception, pruritus, rash, or headache; no trends were observed in clinical laboratory parameters, vital signs, intra-epidermal nerve fiber density, or quantitative sensory testing. BG00010 was not associated with any clear, dose-dependent trends in Likert pain scores. BG00010 was

  20. Glucosamine-containing supplement improves locomotor functions in subjects with knee pain a randomized, double-blind, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Kanzaki N

    2015-10-01

    Full Text Available Noriyuki Kanzaki,1 Yoshiko Ono,1 Hiroshi Shibata,1 Toshio Moritani2 1Institute for Health Care Science, Suntory Wellness Ltd, Seika-cho, Soraku-gun, 2Graduate School of Human and Environmental Studies, Kyoto University, Sakyo-ku, Kyoto, Japan Background: The aim of this study was to investigate the ability of a glucosamine-containing supplement to improve locomotor functions in subjects with knee pain.Methods: A randomized, double-blind, placebo-controlled, parallel-group comparative study was conducted for 16 weeks in 100 Japanese subjects (age, 51.8±0.8 years with knee pain. Subjects were randomly assigned to one of the two supplements containing 1 1,200 mg of glucosamine hydrochloride, 60 mg of chondroitin sulfate, 45 mg of type II collagen peptides, 90 mg of quercetin glycosides, 10 mg of imidazole peptides, and 5 µg of vitamin D per day (GCQID group, n=50 or 2 a placebo (placebo group, n=50. Japanese Knee Osteoarthritis Measure, visual analog scale score, normal walking speed, and knee-extensor strength were measured to evaluate the effects of the supplement on knee-joint functions and locomotor functions.Results: In subjects eligible for efficacy assessment, there was no significant group × time interaction, and there were improvements in knee-joint functions and locomotor functions in both groups, but there was no significant difference between the groups. In subjects with mild-to-severe knee pain at baseline, knee-extensor strength at week 8 (104.6±5.0% body weight vs 92.3±5.5% body weight, P=0.030 and the change in normal walking speed at week 16 (0.11±0.03 m/s vs 0.05±0.02 m/s, P=0.038 were significantly greater in the GCQID group than in the placebo group. Further subgroup analysis based on Kellgren–Lawrence (K–L grade showed that normal walking speed at week 16 (1.36±0.05 m/s vs 1.21±0.02 m/s, P<0.05 was significantly greater in the GCQID group than in the placebo group in subjects with K–L grade I. No

  1. IPP-rich milk protein hydrolysate lowers blood pressure in subjects with stage 1 hypertension, a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kloek Joris

    2010-11-01

    Full Text Available Abstract Background Milk derived peptides have been identified as potential antihypertensive agents. The primary objective was to investigate the effectiveness of IPP-rich milk protein hydrolysates (MPH on reducing blood pressure (BP as well as to investigate safety parameters and tolerability. The secondary objective was to confirm or falsify ACE inhibition as the mechanism underlying BP reductions by measuring plasma renin activity and angiotensin I and II. Methods We conducted a randomized, placebo-controlled, double blind, crossover study including 70 Caucasian subjects with prehypertension or stage 1 hypertension. Study treatments consisted of daily consumption of two capsules MPH1 (each containing 7.5 mg Isoleucine-Proline-Proline; IPP, MPH2 (each containing 6.6 mg Methionine-Alanine-Proline, 2.3 mg Leucine-Proline-Proline, 1.8 mg IPP, or placebo (containing cellulose for 4 weeks. Results In subjects with stage 1 hypertension, MPH1 lowered systolic BP by 3.8 mm Hg (P = 0.0080 and diastolic BP by 2.3 mm Hg (P = 0.0065 compared with placebo. In prehypertensive subjects, the differences in BP between MPH1 and placebo were not significant. MPH2 did not change BP significantly compared with placebo in stage I hypertensive or prehypertensive subjects. Intake of MPHs was well tolerated and safe. No treatment differences in hematology, clinical laboratory parameters or adverse effects were observed. No significant differences between MPHs and placebo were found in plasma renin activity, or angiotensin I and II. Conclusions MPH1, containing IPP and no minerals, exerts clinically relevant BP lowering effects in subjects with stage 1 hypertension. It may be included in lifestyle changes aiming to prevent or reduce high BP. Trial registration ClinicalTrials.gov NCT00471263

  2. Noradrenergic α₁ receptor antagonist treatment attenuates positive subjective effects of cocaine in humans: a randomized trial.

    Directory of Open Access Journals (Sweden)

    Thomas F Newton

    Full Text Available Preclinical research implicates dopaminergic and noradrenergic mechanisms in mediating the reinforcing effects of drugs of abuse, including cocaine. The objective of this study was to evaluate the impact of treatment with the noradrenergic α(1 receptor antagonist doxazosin on the positive subjective effects of cocaine.Thirteen non-treatment seeking, cocaine-dependent volunteers completed this single-site, randomized, placebo-controlled, within-subjects study. In one study phase volunteers received placebo and in the other they received doxazosin, with the order counterbalanced across participants. Study medication was masked by over-encapsulating doxazosin tablets and matched placebo lactose served as the control. Study medication treatment was initiated at 1 mg doxazosin or equivalent number of placebo capsules PO/day and increased every three days by 1 mg. After receiving 4 mg doxazosin or equivalent number of placebo capsules participants received masked doses of 20 and 40 mg cocaine IV in that order with placebo saline randomly interspersed to maintain the blind.Doxazosin treatment was well tolerated and doxazosin alone produced minimal changes in heart rate and blood pressure. During treatment with placebo, cocaine produced dose-dependent increases in subjective effect ratings of "high", "stimulated", "like cocaine", "desire cocaine", "any drug effect", and "likely to use cocaine if had access" (p<.001. Doxazosin treatment significantly attenuated the effects of 20 mg cocaine on ratings of "stimulated", "like cocaine", and "likely to use cocaine if had access" (p<.05. There were trends for doxazosin to reduce ratings of "stimulated", "desire cocaine", and "likely to use cocaine if had access" (p<.10.Medications that block noradrenergic α₁ receptors, such as doxazosin, may be useful as treatments for cocaine dependence, and should be evaluated further.Clinicaltrials.gov NCT01062945.

  3. Zinc monotherapy increases serum brain-derived neurotrophic factor (BDNF) levels and decreases depressive symptoms in overweight or obese subjects: a double-blind, randomized, placebo-controlled trial.

    Science.gov (United States)

    Solati, Zahra; Jazayeri, Shima; Tehrani-Doost, Mehdi; Mahmoodianfard, Salma; Gohari, Mahmood Reza

    2015-05-01

    Previous studies have shown a positive effect of zinc as an adjunctive therapy on reducing depressive symptoms. However, to our knowledge, no study has examined the effect of zinc monotherapy on mood. The aim of the present study was to determine the effects of zinc monotherapy on depressive symptoms and serum brain-derived neurotrophic factor (BDNF) levels in overweight or obese subjects. Fifty overweight or obese subjects were randomly assigned into two groups and received either 30 mg zinc or placebo daily for 12 weeks. At baseline and post-intervention, depression severity was assessed using Beck depression inventory II (BDI II), and serum BDNF and zinc levels were determined by enzyme-linked immunosorbent assay and atomic absorption spectrophotometry, respectively. The trial was completed with 46 subjects. After a 12-week supplementation, serum zinc and BDNF levels increased significantly in the zinc-supplemented group compared with the placebo group. BDI scores declined in both the groups at the end of the study, but reduction in the zinc-supplemented group was significantly higher than the placebo group. More analysis revealed that following supplementation, BDI scores decreased in subgroup of subjects with depressive symptoms (BDI ≥ 10) (n = 30), but did not change in the subgroup of non-depressed subjects (BDI BDNF levels and depression severity in all participants. Interestingly, a significant positive correlation was found between serum BDNF and zinc levels at baseline. Zinc monotherapy improves mood in overweight or obese subjects most likely through increasing BDNF levels.

  4. Aceneuramic Acid Extended Release Administration Maintains Upper Limb Muscle Strength in a 48-week Study of Subjects with GNE Myopathy: Results from a Phase 2, Randomized, Controlled Study

    Science.gov (United States)

    Argov, Zohar; Caraco, Yoseph; Lau, Heather; Pestronk, Alan; Shieh, Perry B.; Skrinar, Alison; Koutsoukos, Tony; Ahmed, Ruhi; Martinisi, Julia; Kakkis, Emil

    2016-01-01

    Background: GNE Myopathy (GNEM) is a progressive adult-onset myopathy likely caused by deficiency of sialic acid (SA) biosynthesis. Objective: Evaluate the safety and efficacy of SA (delivered by aceneuramic acid extended-release [Ace-ER]) as treatment for GNEM. Methods: A Phase 2, randomized, double-blind, placebo-controlled study evaluating Ace-ER 3 g/day or 6 g/day versus placebo was conducted in GNEM subjects (n = 47). After the first 24 weeks, placebo subjects crossed over to 3 g/day or 6 g/day for 24 additional weeks (dose pre-assigned during initial randomization). Assessments included serum SA, muscle strength by dynamometry, functional assessments, clinician- and patient-reported outcomes, and safety. Results: Dose-dependent increases in serum SA levels were observed. Supplementation with Ace-ER resulted in maintenance of muscle strength in an upper extremity composite (UEC) score at 6 g/day compared with placebo at Week 24 (LS mean difference +2.33 kg, p = 0.040), and larger in a pre-specified subgroup able to walk ≥200 m at Screening (+3.10 kg, p = 0.040). After cross-over, a combined 6 g/day group showed significantly better UEC strength than a combined 3 g/day group (+3.46 kg, p = 0.0031). A similar dose-dependent response was demonstrated within the lower extremity composite score, but was not significant (+1.06 kg, p = 0.61). The GNEM-Functional Activity Scale demonstrated a trend improvement in UE function and mobility in a combined 6 g/day group compared with a combined 3 g/day group. Patients receiving Ace-ER tablets had predominantly mild-to-moderate AEs and no serious adverse events. Conclusions: This is the first clinical study to provide evidence that supplementation with SA delivered by Ace-ER may stabilize muscle strength in individuals with GNEM and initiating treatment earlier in the disease course may lead to better outcomes. PMID:27854209

  5. A Randomized, Phase I Pharmacokinetic Study Comparing SB2 and Infliximab Reference Product (Remicade(®)) in Healthy Subjects.

    Science.gov (United States)

    Shin, Donghoon; Kim, Youngdoe; Kim, Yoo Seok; Körnicke, Thomas; Fuhr, Rainard

    2015-12-01

    SB2, a biosimilar to infliximab reference product (INF), has an identical amino acid sequence and similar physicochemical functional properties to its reference product. The primary objective of this study is to demonstrate pharmacokinetic (PK) bioequivalence between SB2 and EU-sourced INF (EU-INF), between SB2 and US-sourced INF (US-INF), and between EU-INF and US-INF. This study was a randomized, single-blind, three-arm, parallel group study in 159 healthy subjects. All subjects received a single 5 mg/kg intravenous infusion of study drug and then were observed for 10 weeks to study PK, safety and immunogenicity. The primary PK parameters were area under the concentration-time curve (AUC) from time zero to infinity (AUCinf), AUC from time zero to the last quantifiable concentration (AUClast) and maximum concentration (C max). Bioequivalence for the primary PK parameters was to be concluded using an analysis of variance (ANOVA) if the 90 % confidence intervals (CIs) for the ratio of geometric least squares means (LSMeans) of the treatments compared were completely contained within the pre-defined equivalence margin, 0.8-1.25. All of the 90 % CIs for the geometric LSMean ratios of primary PK parameters for each comparison were within the pre-defined equivalence margin. The proportion of subjects who experienced treatment-emergent adverse events was comparable between treatments. The incidences of anti-drug antibodies between the three treatments were comparable. This study demonstrated biosimilarity of SB2 to its marketed reference products of infliximab in terms of PK equivalence in healthy subjects. SB2 was generally well tolerated and showed comparable safety and immunogenicity profiles to the reference products (ClinicalTrials.gov Identifier: NCT01922336).

  6. Effects of smartphone-based memory training for older adults with subjective memory complaints: a randomized controlled trial.

    Science.gov (United States)

    Oh, Seo Jin; Seo, Sungmin; Lee, Ji Hyun; Song, Myeong Ju; Shin, Min-Sup

    2017-01-10

    We explored whether newly developed application (Smartphone-based brain Anti-aging and memory Reinforcement Training, SMART) improved memory performance in older adults with subjective memory complaints (SMC). A total of 53 adults (range: 50-68 years; 52.8% female) were randomized into either one of two intervention groups [SMART (n = 18) vs. Fit Brains® (n = 19)] or a wait-list group (n = 16). Participants in the intervention groups underwent 15-20 minutes of training per day, five days per week for 8 weeks. We used objective cognitive measures to evaluate changes with respect to four domains: attention, memory, working memory (WM), and response inhibition. In addition, we included self-report questionnaires to assess levels of SMC, depression, and anxiety. Total WM quotient [t(17) = 6.27, p smartphone-based memory training program may improve WM function in older adults. However, objective improvement in performance does not necessarily lead to decreased SMC.

  7. Meditation and Music Improve Memory and Cognitive Function in Adults with Subjective Cognitive Decline: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Innes, Kim E; Selfe, Terry Kit; Khalsa, Dharma Singh; Kandati, Sahiti

    2017-01-01

    While effective therapies for preventing or slowing cognitive decline in at-risk populations remain elusive, evidence suggests mind-body interventions may hold promise. In this study, we assessed the effects of Kirtan Kriya meditation (KK) and music listening (ML) on cognitive outcomes in adults experiencing subjective cognitive decline (SCD), a strong predictor of Alzheimer's disease. Sixty participants with SCD were randomized to a KK or ML program and asked to practice 12 minutes/day for 3 months, then at their discretion for the ensuing 3 months. At baseline, 3 months, and 6 months we measured memory and cognitive functioning [Memory Functioning Questionnaire (MFQ), Trail-making Test (TMT-A/B), and Digit-Symbol Substitution Test (DSST)]. The 6-month study was completed by 53 participants (88%). Participants performed an average of 93% (91% KK, 94% ML) of sessions in the first 3 months, and 71% (68% KK, 74% ML) during the 3-month, practice-optional, follow-up period. Both groups showed marked and significant improvements at 3 months in memory and cognitive performance (MFQ, DSST, TMT-A/B; p's≤0.04). At 6 months, overall gains were maintained or improved (p's≤0.006), with effect sizes ranging from medium (DSST, ML group) to large (DSST, KK group; TMT-A/B, MFQ). Changes were unrelated to treatment expectancies and did not differ by age, gender, baseline cognition scores, or other factors. Findings of this preliminary randomized controlled trial suggest practice of meditation or ML can significantly enhance both subjective memory function and objective cognitive performance in adults with SCD, and may offer promise for improving outcomes in this population.

  8. The Effect of a Vegetarian vs Conventional Hypocaloric Diabetic Diet on Thigh Adipose Tissue Distribution in Subjects with Type 2 Diabetes: A Randomized Study.

    Science.gov (United States)

    Kahleova, Hana; Klementova, Marta; Herynek, Vit; Skoch, Antonin; Herynek, Stepan; Hill, Martin; Mari, Andrea; Pelikanova, Terezie

    2017-07-01

    The aim of our study was to compare the effects of a vegetarian and a conventional diet on thigh adipose tissue distribution in subjects with type 2 diabetes (T2D). Seventy-four subjects with T2D were randomly assigned to either follow a vegetarian diet (V, n = 37) or a control group who followed an isocaloric conventional anti-diabetic diet (C, n = 37). Both diets were calorie restricted (-500 kcal/day). To measure insulin sensitivity, the hyperinsulinemic (1 mU.kg(-1).min(-1)) isoglycemic clamp was conducted. β-Cell function was assessed using a mathematical model after a test meal. Magnetic resonance imaging of the thigh was performed. All subjects were examined at 0, 3, and 6 months. Statistical analyses were performed using repeated measures analysis of variance and a multivariate regression model. Greater reduction was observed in total leg area in V (-13.6 cm(2) [95% confidence interval [CI], -14.2 to -12.9] in V vs -9.9 cm(2) [95% CI, -10.6 to -9.2] in C; Gxt p vegetarian diet (-0.82 [95% CI, -1.13 to -0.55] cm(2) in V vs -0.44 [95% CI, -0.78 to +0.02] cm(2) in C; Gxt, p = 0.04). The reduction in intramuscular fat tended to be greater in response to a vegetarian diet (-1.78 [95% CI, -2.26 to -1.27] cm(2) in V vs -0.57 [95% CI, -1.06 to -0.09] cm(2) in C; Gxt, p = 0.12). Changes in subcutaneous and subfascial fat correlated with changes in glycated hemoglobin (HbA1c), fasting plasma glucose, and β-cell insulin sensitivity. After adjustment for changes in body mass index (BMI), correlations remained significant for changes in fasting plasma glucose and β-cell insulin sensitivity and with changes in triglycerides. Our data indicate the importance of both subcutaneous and subfascial fat in relationship to glucose and lipid metabolism. BMI , body mass index; C , control group; FPG , fasting plasma glucose; Gxt , interaction between group and time; HbA1c , glycated hemoglobin; MCR , metabolic clearance rate of glucose; OPLS , orthogonal projections to

  9. Model and Effectiveness of Endurance Exercise to Increase Physical Fitness in Intellectual Disability Subjects with Obesity: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Tirza Z Tamin

    2015-04-01

    Full Text Available Aim: to design a model and assess the effectiveness of endurance exercise to increase physical fitness in intelectual disability (ID patients with obesity. Methods: a randomized-controlled clinical trial was performed in ID patients with obesity aged 10-30 years old from all Special School in DKI Jakarta, which were randomly allocated into 3 groups and then given 3 different type of exercises: lower extremity muscles endurance exercise for 20 RM followed by cardiorespiratory endurance exercise for 24-25 minutes (type I, lower extremity muscles endurance exercises for 10 RM followed by cardiorespiratory endurance exercises for 26-27 minutes (type II, and threw a tennis ball with 10 m distance for 10 minutes as control (type III. These program was performed 3 times a week for 4 months. Assesment of the exercise effectiveness was done by measuring maximum load that can be lifted and six-minutes walking test on rectangular track which was converted with the VO2 max prediction formula. Analysis was perfomed with Kruskal Wallis test. Results: two hundred and twelve (212 subjects were included in the study, randomly allocated into three types (I, II, and III of exercises groups. The type II of endurance exercise model was proved to be more effective in increasing lower extremity muscles endurance level compared to type I and III for ID patients with obesity (p<0.05. Meanwhile, type I of endurance exercise model was proved to be more effective in increasing cardiorespiratory endurance level compared to type II and III for ID patients with obesity (p<0.05. Conclusion: lower extremity muscles endurance exercise followed by a cardiorespiratory endurance exercise can be used to increase physical fitness in ID patients with obesity. Key words: intelectual disability patient, obesity, lower extremity muscles and cardiorespiratory endurance exercise, lower extremity muscles endurance level, cardiorespiratory endurance level.

  10. Assessment of subjective and hemodynamic tolerance of different high- and low-flux dialysis membranes in patients undergoing chronic intermittent hemodialysis: a randomized controlled trial.

    Science.gov (United States)

    Bianchi, Giorgia; Salvadé, Vanja; Lucchini, Barbara; Schätti-Stählin, Sibylle; Salvadé, Igor; Burnier, Michel; Gabutti, Luca

    2014-10-01

    Clinical experience and experimental data suggest that intradialytic hemodynamic profiles could be influenced by the characteristics of the dialysis membranes. Even within the worldwide used polysulfone family, intolerance to specific membranes was occasionally evoked. The aim of this study was to compare hemodynamically some of the commonly used polysulfone dialyzers in Switzerland. We performed an open-label, randomized, cross-over trial, including 25 hemodialysis patients. Four polysulfone dialyzers, A (Revaclear high-flux, Gambro, Stockholm, Sweden), B (Helixone high-flux, Fresenius), C (Xevonta high-flux, BBraun, Melsungen, Germany), and D (Helixone low-flux, Fresenius, Bad Homburg vor der Höhe, Germany), were compared. The hemodynamic profile was assessed and patients were asked to provide tolerance feedback. The mean score (±SD) subjectively assigned to dialysis quality on a 1-10 scale was A 8.4 ± 1.3, B 8.6 ± 1.3, C 8.5 ± 1.6, D 8.5 ± 1.5. Kt/V was A 1.58 ± 0.30, B 1.67 ± 0.33, C 1.62 ± 0.32, D 1.45 ± 0.31. The low- compared with the high-flux membranes, correlated to higher systolic (128.1 ± 13.1 vs. 125.6 ± 12.1 mmHg, P 20 mmHg) were 70 with A, 87 with B, 73 with C, and 75 with D (P Hemodialysis.

  11. A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of neramexane in patients with moderate to severe subjective tinnitus

    Directory of Open Access Journals (Sweden)

    Jastreboff Pawel J

    2011-01-01

    Full Text Available Abstract Background Neramexane is a new substance that exhibits antagonistic properties at α9α10 cholinergic nicotinic receptors and N-methyl-D-aspartate receptors, suggesting potential efficacy in the treatment of tinnitus. Methods A total of 431 outpatients with moderate to severe subjective tinnitus (onset 3-18 months before screening were assigned randomly to receive either placebo or neramexane mesylate (25 mg/day, 50 mg/day and 75 mg/day for 16 weeks, with assessment at 4-week intervals. The primary (intention-to-treat efficacy analysis was based on the change from baseline in Week 16 in the total score of the adapted German short version of the validated Tinnitus Handicap Inventory questionnaire (THI-12. Results Compared with placebo, the largest improvement was achieved in the 50 mg/d neramexane group, followed by the 75 mg/d neramexane group. This treatment difference did not reach statistical significance at the pre-defined endpoint in Week 16 (p = 0.098 for 50 mg/d; p = 0.289 for 75 mg/d neramexane, but consistent numerical superiority of both neramexane groups compared with placebo was observed. Four weeks after the end of treatment, THI-12 scores in the 50 mg/d group were significantly better than those of the controls. Secondary efficacy variables supported this trend, with p values of Conclusions This study demonstrated the safety and tolerability of neramexane treatment in patients with moderate to severe tinnitus. The primary efficacy variable showed a trend towards improvement of tinnitus suffering in the medium- and high-dose neramexane groups. This finding is in line with consistent beneficial effects observed in secondary assessment variables. These results allow appropriate dose selection for further studies. Trial Registration ClinicalTrials.gov NCT00405886

  12. Extracorporeal shock wave therapy in patients with plantar fasciitis. A randomized, placebo-controlled trial with ultrasonographic and subjective outcome assessments

    Directory of Open Access Journals (Sweden)

    Babak Vahdatpour

    2012-01-01

    Full Text Available Background and Aim: Results of previous studies have been conflicting on the efficacy of extracorporeal shock wave therapy (ESWT in the treatment of plantar fasciitis. We evaluated the effects of ESWT on plantar fasciitis in terms of ultrasonographic and subjective evaluations. Materials and Methods: In this randomized placebo-controlled trial, patients with plantar fasciitis were assigned to receive ESWT (4000 shock waves/session of 0.2 mJ/mm 2 in 3 sessions at weekly intervals or sham therapy (n = 20 in each group. Outcomes were documented by the ultrasonographic appearance of the aponeurosis and by patients′ pain scores, performed at baseline and 12 weeks after completion of the therapy. Results : The two groups were similar in baseline characteristics. Over the study period, plantar fascia thickness significantly reduced in the ESWT group (4.1 ± 1.3 to 3.6 ± 1.2 mm, P < 0.001, but slightly increased in the sham group (4.1 ± 0.8 to 4.5 ± 0.9 mm, P = 0.03. Both groups showed significant pain improvement over the course of the study (P < 0.001, though pain scores were significantly more reduced in the ESWT than the sham group (-4.2 ± 2.9 vs. -2.7 ± 1.8, P = 0.049. Conclusions: Extracorporeal shock wave therapy contributes to healing and pain reduction in plantar fasciitis and ultrasound imaging is able to depict the morphologic changes related to plantar fasciitis as a result of this therapy.

  13. Elastic Tape Improved Shoulder Joint Position Sense in Chronic Hemiparetic Subjects: A Randomized Sham-Controlled Crossover Study

    Science.gov (United States)

    Souza, Matheus Bragança; Desloovere, Kaat; Russo, Thiago Luiz

    2017-01-01

    Background Elastic tape has been widely used in clinical practice in order to improve upper limb (UL) sensibility. However, there is little evidence that supports this type of intervention in stroke patients. Objective To verify the effect of elastic tape, applied to the paretic shoulder, on joint position sense (JPS) during abduction and flexion in subjects with chronic hemiparesis compared to sham tape (non-elastic tape). Furthermore, to verify if this potential effect is correlated to shoulder subluxation measurements and sensorimotor impairment. Methods A crossover and sham-controlled study was conducted with post-stroke patients who were randomly allocated into two groups: 1) those who received Sham Tape (ST) first and after one month they received Elastic Tape (ET); 2) those who received Elastic Tape (ET) first and after one month they received Sham Tape (ST). The JPS was evaluated using a dynamometer. The absolute error for shoulder abduction and flexion at 30° and 60° was calculated. Sensorimotor impairment was determined by Fugl-Meyer, and shoulder subluxation was measured using a caliper. Results Thirteen hemiparetic subjects (average time since stroke 75.23 months) participated in the study. At baseline (before interventions), the groups were not different for abduction at 30° (p = 0.805; p = 0.951), and 60° (p = 0.509; p = 0.799), or flexion at 30° (p = 0.872; p = 0.897) and 60° (p = 0.853; p = 0.970). For the ET group, differences between pre and post-elastic tape for abduction at 30° (ptape for abduction at 30° (ptape improved shoulder JPS of subjects with chronic hemiparesis regardless of the level of UL sensorimotor impairment. However, this improvement was influenced by the subluxation degree at abduction. PMID:28099472

  14. Safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat inhaled doses of umeclidinium in healthy subjects: two randomized studies.

    Science.gov (United States)

    Cahn, Anthony; Tal-Singer, Ruth; Pouliquen, Isabelle J; Mehta, Rashmi; Preece, Andrew; Hardes, Kelly; Crater, Glenn; Deans, Amanda

    2013-07-01

    Chronic obstructive pulmonary disease (COPD) has a significant negative impact on quality of life and increases the risk of premature death. Umeclidinium is a long-acting muscarinic receptor antagonist in development for the treatment of COPD with the aim to broaden treatment options for clinicians and patients by providing improved symptom control. To characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat inhaled doses of umeclidinium in healthy subjects. Two randomized, placebo-controlled, ascending-dose studies were conducted in healthy ipratropium bromide-responsive subjects. In the single-dose study, subjects (n = 20) received umeclidinium (10-350 μg), tiotropium bromide 18 μg and placebo in a crossover dosing schedule. In this study, lung function was assessed for 24 h by measuring specific airways conductance (sGaw) and forced expiratory volume in 1 s (FEV1). In the repeat-dose study, subjects (n = 36) received umeclidinium (250-1,000 μg) and placebo for 14 days in a parallel-group schedule. Adverse events (AEs) were reported in five subjects (single-dose study) and 23 subjects (repeat-dose study); none were serious. In both studies, no abnormalities in 12-lead electrocardiogram parameters, 24-h Holter monitoring or lead II monitoring were reported as AEs. Umeclidinium was rapidly absorbed following single-dose administration [time to reach the maximum plasma concentration (tmax) 5-15 min] and repeat-dose administration (tmax 5-7 min). Following repeat dosing, the geometric mean plasma elimination half-life was approximately 27 h and statistically significant accumulation was observed for the area under the plasma concentration-time curve, maximum plasma concentration and cumulative amount of unchanged drug excreted into the urine at 24 h (range 1.5- to 4.5-fold). Umeclidinium at doses of 100 μg and above, and tiotropium bromide demonstrated statistically significant bronchodilatory effects

  15. Pilates-based therapeutic exercise: effect on subjects with nonspecific chronic low back pain and functional disability: a randomized controlled trial.

    Science.gov (United States)

    Rydeard, Rochenda; Leger, Andrew; Smith, Drew

    2006-07-01

    A randomized controlled trial, prestest-posttest design, with a 3-, 6-, and 12-month follow-up. To investigate the efficacy of a therapeutic exercise approach in a population with chronic low back pain (LBP). Therapeutic approaches developed from the Pilates method are becoming increasingly popular; however, there have been no reports on their efficacy. Thirty-nine physically active subjects between 20 and 55 years old with chronic LBP were randomly assigned to 1 of 2 groups. The specific-exercise-training group participated in a 4-week program consisting of training on specialized (Pilates) exercise equipment, while the control group received the usual care, defined as consultation with a physician and other specialists and healthcare professionals, as necessary. Treatment sessions were designed to train the activation of specific muscles thought to stabilize the lumbar-pelvic region. Functional disability outcomes were measured with The Roland Morris Disability Questionnaire (RMQ/RMDQ-HK) and average pain intensity using a 101-point numerical rating scale. There was a significantly lower level of functional disability (P = .023) and average pain intensity (P = .002) in the specific-exercise-training group than in the control group following the treatment intervention period. The posttest adjusted mean in functional disability level in the specific-exercise-training group was 2.0 (95% CI, 1.3 to 2.7) RMQ/RMDQ-HK points compared to a posttest adjusted mean in the control group of 3.2 (95% CI, 2.5 to 4.0) RMQ/RMDQ-HK points. The posttest adjusted mean in pain intensity in the specific-exercise-training group was 18.3 (95% CI, 11.8 to 24.8), as compared to 33.9 (95% CI, 26.9 to 41.0) in the control group. Improved disability scores in the specific-exercise-training group were maintained for up to 12 months following treatment intervention. The individuals in the specific-exercise-training group reported a significant decrease in LBP and disability, which was

  16. Reducing worry and subjective health complaints: A randomized trial of an internet-delivered worry postponement intervention.

    Science.gov (United States)

    Versluis, Anke; Verkuil, Bart; Brosschot, Jos F

    2016-05-01

    Several studies have shown that perseverative, worrisome thoughts are prospectively related to subjective health complaints (SHC) and that a short worry postponement intervention can decrease these complaints. As SHC and worry are prevalent and costly, we tested whether the intervention can be offered online to reduce these complaints in the general population. A randomized parallel-group trial was conducted with self-selected participants from the general population. Via the research website, 996 participants were instructed to register their worrying for 6 consecutive days. The intervention group was instructed to postpone worry to a special 30-min period in the early evening. The Subjective Health Complaints inventory, as administered before and after the intervention, and daily worry frequency and duration were considered the primary outcomes. Three hundred and sixty-one participants completed the study. Contrary to our expectation, the registration group (n = 188) did not differ from the intervention group (n = 163) in SHC (ηp² = .000, CI [0.000-0.003]), or in worry frequency or duration. Nevertheless, the different worry parameters were moderately related to SHC (r between .238 and .340, p ≤ .001). In contrast to previous studies using pen-and-pencil versions of the worry postponement intervention, this study suggests that a direct online implementation was not effective in reducing SHC and worry. Overall, participants had high trait worry levels and reported difficulty with postponing worrying. Reducing SHC and worries via the Internet might require more elaborate interventions that better incorporate the advantages of delivering interventions online. What is already known on this subject? The perseverative cognition hypothesis argues that perseverative cognition, such as worry and rumination, acts as a mediator by which psychosocial stress may produce negative health effects. Prior research has indeed shown that worry and subjective health complaints

  17. Scaffolding students’ assignments

    DEFF Research Database (Denmark)

    Slot, Marie Falkesgaard

    2013-01-01

    This article discusses scaffolding in typical student assignments in mother tongue learning materials in upper secondary education in Denmark and the United Kingdom. It has been determined that assignments do not have sufficient scaffolding end features to help pupils understand concepts and build...

  18. A single consumption of curry improved postprandial endothelial function in healthy male subjects: a randomized, controlled crossover trial.

    Science.gov (United States)

    Nakayama, Hideki; Tsuge, Nobuaki; Sawada, Hiroshi; Masamura, Noriya; Yamada, Shohei; Satomi, Shigeki; Higashi, Yukihito

    2014-06-28

    Curry, one of the most popular foods in Japan, contains spices that are rich in potentially antioxidative compounds, such as curcumin and eugenol. Oxidative stress is thought to impair endothelial function associated with atherosclerosis, a leading cause of cardiovascular events. The aim of this study was to determine whether a single consumption of curry meal would improve endothelial function in healthy men. Fourteen healthy male subjects (BMI 23.7 ± 2.7 kg/m2; age 45 ± 9 years) were given a single serving of curry meal or spice-free control meal (180 g of curry or control and 200 g of cooked rice; approximately 500 kcal in total) in a randomized, controlled crossover design. Before and 1 hr after the consumption, fasting and postprandial flow-mediated vasodilation (FMD) responses and other parameters were measured. The consumption of the control meal decreased FMD from 5.8 ± 2.4% to 5.1 ± 2.3% (P = 0.039). On the other hand, the consumption of the curry meal increased FMD from 5.2 ± 2.5% to 6.6 ± 2.0% (P = 0.001), and the postprandial FMD after the curry meal was higher than that after the control meal (P = 0.002). Presence of spices in the curry did not alter significantly the systemic and forearm hemodynamics, or any biochemical parameters including oxidative stress markers measured. These findings suggest that the consumption of curry ameliorates postprandial endothelial function in healthy male subjects and may be beneficial for improving cardiovascular health. UMIN Clinical Trials Registry 000012012.

  19. Improvement of glucose and lipid profile status with Aloe vera in pre-diabetic subjects: a randomized controlled-trial.

    Science.gov (United States)

    Alinejad-Mofrad, Samaneh; Foadoddini, Mohsen; Saadatjoo, Seyed Alireza; Shayesteh, Majid

    2015-01-01

    Pre-diabetes is a disturbing trend in the population, who are at risk of developing type-two diabetes. The aim of this study was to determine the effects use of Aloe vera in different doses on glucose and lipid profile in pre-diabetic subjects. This study was a double blind randomized controlled trial (72 subjects) with pre-diabetes symptoms in 3 groups consumed capsules twice a day: Aloe vera 300 mg (AL300), 500 mg (AL500) and placebo (PL). Fasting blood glucose (FBS), HbA1C and lipid profile were evaluated in baseline, 4 or 8 weeks. On-way ANOVA, Friedman, Wilcoxon, Kruskal-Wallis , Mann-Whitney and Chi-square tests were used for within or between groups statistical analysis. FBS level in group AL300, showed significantly decreased in fourth week after the intervention, compared to PL in the same time (p = 0.001). Also, HbA1C level in this group at the eighth week after the intervention (p = 0.042), had a significant decrease. The levels of Total cholesterol and LDL-C, only in the group AL500 (p < 0.001 and p = 0.01), was significantly reduced, along with HDL-C level improvement just after eight weeks (p = 0.004). Triglyceride level showed a significant decrease (p < 0.045) just after four weeks use of AL500. The Use of Aloe vera extract in pre-diabetic patients, could revert impaired blood glucose within four weeks, but after eight weeks could alleviate their abnormal lipid profile.

  20. A phase 2a randomized controlled study to evaluate the pharmacokinetic, safety, tolerability and clinical effect of topically applied Umeclidinium in subjects with primary axillary hyperhidrosis.

    Science.gov (United States)

    Nasir, A; Bissonnette, R; Maari, C; DuBois, J; Pene Dumitrescu, T; Haddad, J; Yamaguchi, Y; Dalessandro, M

    2018-01-01

    Hyperhidrosis is a common medical condition which can have a significant impact on quality of life. Umeclidinium (UMEC) is a long-acting muscarinic antagonist (LAMA) developed as a dermal formulation. This 2-week, double-blind, randomized, vehicle-controlled study evaluated systemic exposure, safety and tolerability of topically administered UMEC in subjects with primary axillary hyperhidrosis. Clinical effect was a secondary objective, measured by gravimetry and the hyperhidrosis disease severity scale (HDSS). Vehicle was included to evaluate safety. Twenty-three subjects were randomized to either 1.85% UMEC (N = 18) or vehicle (N = 5) once daily. Measurable plasma concentrations were observed in 78% of subjects after the treatment. Nine subjects (50%) on UMEC and two subjects (40%) on vehicle reported AEs, most commonly application site reactions. At Day 15, seven subjects (41%) in UMEC and two subjects (40%) in vehicle had at least a 50% reduction in sweat production. Eight subjects (47%) in UMEC and one subject (20%) in vehicle had at least a two-point reduction in HDSS. No comparisons of treatment arms were planned prospectively. The measurable exposure, acceptable safety and preliminary clinical activity observed in this proof-of-concept study suggest the potential clinical utility of topical UMEC in subjects with axillary hyperhidrosis. © 2017 European Academy of Dermatology and Venereology.

  1. Impacts of Supervised Exercise Training in Addition to Interdisciplinary Lifestyle Management in Subjects Awaiting Bariatric Surgery: a Randomized Controlled Study.

    Science.gov (United States)

    Baillot, Aurélie; Mampuya, Warner M; Dionne, Isabelle J; Comeau, Emilie; Méziat-Burdin, Anne; Langlois, Marie-France

    2016-11-01

    Experts recommend physical activity (PA) to optimize bariatric surgery (BS) results. However, evidence on the effect of PA before BS is missing. The aim of this study was to assess the impact of adding a Pre-Surgical Exercise Training (PreSET) to an interdisciplinary lifestyle intervention on physical fitness, quality of life, PA barriers, and anthropometric parameters of subjects awaiting BS. Thirty candidates for BS (43.2 ± 9.2 years, 47.5 ± 8.1 kg/m2) have been randomized in two groups: one group following the PreSET (endurance and strength training) and another receiving usual care. Before and after 12 weeks, we assessed physical fitness with a battery of tests (symptom-limited exercise test, 6-min walk test (6MWT), sit-to-stand test, half-squat test, and arm curl test), quality of life with the laval questionnaire, and PA barriers with the physical exercise belief questionnaire. One control group subject abandoned the study. Subjects in the PreSET group participated in 60.0 % of the supervised exercise sessions proposed. Results showed significant improvements in the 6MWT (17.4 ± 27.2 vs. -16.4 ± 42.4 m; p = 0.03), half-squat test (17.1 ± 17.9 vs. -0.9 ± 14.5 s; p = 0.05), arm curl repetitions (4.8 ± 2.3 vs. 1.0 ± 4.1; p = 0.01), social interaction score (10.7 ± 12.5 vs. -2.1 ± 11.0 %; p = 0.02), and embarrassment (-15.6 ± 10.2 vs. -3.1 ± 17.8 %; p = 0.02) in completers (n = 8) compared to the non-completers (n = 21). No significant difference between groups in BMI and other outcomes studied was observed after the intervention. Adding a PreSET to an individual lifestyle counselling intervention improved physical fitness, social interactions, and embarrassment. Post-surgery data would be interesting to confirm these benefits on the long term.

  2. Fast Random Permutation Tests Enable Objective Evaluation of Methods for Single-Subject fMRI Analysis

    Directory of Open Access Journals (Sweden)

    Anders Eklund

    2011-01-01

    Full Text Available Parametric statistical methods, such as Z-, t-, and F-values, are traditionally employed in functional magnetic resonance imaging (fMRI for identifying areas in the brain that are active with a certain degree of statistical significance. These parametric methods, however, have two major drawbacks. First, it is assumed that the observed data are Gaussian distributed and independent; assumptions that generally are not valid for fMRI data. Second, the statistical test distribution can be derived theoretically only for very simple linear detection statistics. With nonparametric statistical methods, the two limitations described above can be overcome. The major drawback of non-parametric methods is the computational burden with processing times ranging from hours to days, which so far have made them impractical for routine use in single-subject fMRI analysis. In this work, it is shown how the computational power of cost-efficient graphics processing units (GPUs can be used to speed up random permutation tests. A test with 10000 permutations takes less than a minute, making statistical analysis of advanced detection methods in fMRI practically feasible. To exemplify the permutation-based approach, brain activity maps generated by the general linear model (GLM and canonical correlation analysis (CCA are compared at the same significance level.

  3. Fast Random Permutation Tests Enable Objective Evaluation of Methods for Single-Subject fMRI Analysis

    Science.gov (United States)

    Eklund, Anders; Andersson, Mats; Knutsson, Hans

    2011-01-01

    Parametric statistical methods, such as Z-, t-, and F-values, are traditionally employed in functional magnetic resonance imaging (fMRI) for identifying areas in the brain that are active with a certain degree of statistical significance. These parametric methods, however, have two major drawbacks. First, it is assumed that the observed data are Gaussian distributed and independent; assumptions that generally are not valid for fMRI data. Second, the statistical test distribution can be derived theoretically only for very simple linear detection statistics. With nonparametric statistical methods, the two limitations described above can be overcome. The major drawback of non-parametric methods is the computational burden with processing times ranging from hours to days, which so far have made them impractical for routine use in single-subject fMRI analysis. In this work, it is shown how the computational power of cost-efficient graphics processing units (GPUs) can be used to speed up random permutation tests. A test with 10000 permutations takes less than a minute, making statistical analysis of advanced detection methods in fMRI practically feasible. To exemplify the permutation-based approach, brain activity maps generated by the general linear model (GLM) and canonical correlation analysis (CCA) are compared at the same significance level. PMID:22046176

  4. Probiotics, Symptoms, and Gut Microbiota: What Are the Relations? A Randomized Controlled Trial in Subjects with Irritable Bowel Syndrome

    Directory of Open Access Journals (Sweden)

    Per G. Farup

    2012-01-01

    Full Text Available Introduction. Knowledge of the mechanism of action of probiotics in subjects with irritable bowel syndrome (IBS is imperfect. Objective. This trial aimed at discriminating between a direct effect on the gut wall and an indirect effect caused by modulation of the fecal microbiota. Design. Randomized, double-blind, crossover trial. Material and Methods. Patients with IBS were given one capsule of 1010 CFU L. plantarum MF 1298 or placebo once daily. Symptoms were registered (score 0–15 and feces collected at the end of each period. The gut microbiota was analyzed with 16S rRNA gene analyses and results reported as proportions of Bacteroides, Faecalibacterium, and Lachnospiraceae and Simpson’s D diversity score. Results. Sixteen participants (11 women with a mean age of 50 years (SD 11 were available for the analyses. Intake of L. plantarum MF 1298 was associated with a significant aggravation of symptoms, but neither intake of L. plantarum MF 1298 nor symptoms were associated with the composition of the fecal microbiota (P values >0.10. Conclusions. The trial indicates that the symptomatic aggravation related to intake of L. plantarum MF 1298 was a direct effect of the microbe on the gut wall and not caused by changes in the fecal microbiota.

  5. Comparison of statistical and operational properties of subject randomization procedures for large multicenter clinical trial treating medical emergencies

    Science.gov (United States)

    Zhao, Wenle; Mu, Yunming; Tayama, Darren; Yeatts, Sharon D.

    2015-01-01

    Large multicenter acute stroke trials demand a randomization procedure with a high level of treatment allocation randomness, an effective control on overall and within-site imbalances, and a minimized time delay of study treatment caused by the randomization procedure. Driven by the randomization algorithm design of A Study of the Efficacy and Safety of Activase (Alteplase) in Patients With Mild Stroke (PRISMS) (NCT02072226), this paper compares operational and statistical properties of different randomization algorithms in local, central, and step-forward randomization settings. Results show that the step-forward randomization with block urn design provides better performances over others. If the concern on the potential time delay is not serious and a central randomization system is available, the minimization method with an imbalance control threshold and a biased coin probability could be a better choice. PMID:25638754

  6. Historical WBAN ID Assignments

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — 4"x6" index cards represent the first written assignments of Weather Bureau Army Navy (WBAN) station identifier numbers by the National Climatic Data Center....

  7. My Favorite Assignment.

    Science.gov (United States)

    Post, Robert E.; Johnson, Jack E.

    1982-01-01

    Presents two assignments that show (1) how George Orwell's "Politics and the English Language" can be applied to business writing and (2) how structured student-teacher conferences can generate enthusiasm for oral expression in a business communication course. (AEA)

  8. Whole Grain Intake and Glycaemic Control in Healthy Subjects: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Stefano Marventano

    2017-07-01

    Full Text Available Backgrounds: There is growing evidence from both observational and intervention studies that Whole Grain (WG cereals exert beneficial effects on human health, especially on the metabolic profile. The aim of this study was to perform a meta-analysis of randomised controlled trials (RCT to assess the acute and medium/long-term effect of WG foods on glycaemic control and insulin sensitivity in healthy individuals. Methods: A search for all the published RCT on the effect of WG food intake on glycaemic and insulin response was performed up to December 2016. Effect size consisted of mean difference (MD and 95% CI between the outcomes of intervention and the control groups using the generic inverse-variance random effects model. Results: The meta-analysis of the 14 studies testing the acute effects of WG foods showed significant reductions of the post-prandial values of the glucose iAUC (0–120 min by −29.71 mmol min/L (95% CI: −43.57, −15.85 mmol min/L, the insulin iAUC (0–120 min by −2.01 nmol min/L (95% CI: −2.88, −1.14 nmol min/L, and the maximal glucose and insulin response. In 16 medium- and long-term RCTs, effects of WG foods on fasting glucose and insulin and homeostatic model assessment-insulin resistance values were not significant. Conclusions: The consumption of WG foods is able to improve acutely the postprandial glucose and insulin homeostasis compared to similar refined foods in healthy subjects. Further research is needed to better understand the long-term effects and the biological mechanisms.

  9. FLEET ASSIGNMENT MODELLING

    Directory of Open Access Journals (Sweden)

    2016-01-01

    Full Text Available The article is devoted to the airline scheduling process and methods of its modeling. This article describes the main stages of airline scheduling process (scheduling, fleet assignment, revenue management, operations, their features and interactions. The main part of scheduling process is fleet assignment. The optimal solution of the fleet assignment problem enables airlines to increase their incomes up to 3 % due to quality improving of connections and execution of the planned number of flights operated by less number of aircraft than usual or planned earlier. Fleet assignment of scheduling process is examined and Conventional Leg-Based Fleet Assignment Model is analyzed. Finally strong and weak aspects of the model (SWOT are released and applied. The article gives a critical analysis of FAM model, with the purpose of identi- fying possible options and constraints of its use (for example, in cases of short-term and long-term planning, changing the schedule or replacing the aircraft, as well as possible ways to improve the model.

  10. Using Exponential Random Graph Models to Analyze the Character of Peer Relationship Networks and Their Effects on the Subjective Well-being of Adolescents.

    Science.gov (United States)

    Jiao, Can; Wang, Ting; Liu, Jianxin; Wu, Huanjie; Cui, Fang; Peng, Xiaozhe

    2017-01-01

    The influences of peer relationships on adolescent subjective well-being were investigated within the framework of social network analysis, using exponential random graph models as a methodological tool. The participants in the study were 1,279 students (678 boys and 601 girls) from nine junior middle schools in Shenzhen, China. The initial stage of the research used a peer nomination questionnaire and a subjective well-being scale (used in previous studies) to collect data on the peer relationship networks and the subjective well-being of the students. Exponential random graph models were then used to explore the relationships between students with the aim of clarifying the character of the peer relationship networks and the influence of peer relationships on subjective well being. The results showed that all the adolescent peer relationship networks in our investigation had positive reciprocal effects, positive transitivity effects and negative expansiveness effects. However, none of the relationship networks had obvious receiver effects or leaders. The adolescents in partial peer relationship networks presented similar levels of subjective well-being on three dimensions (satisfaction with life, positive affects and negative affects) though not all network friends presented these similarities. The study shows that peer networks can affect an individual's subjective well-being. However, whether similarities among adolescents are the result of social influences or social choices needs further exploration, including longitudinal studies that investigate the potential processes of subjective well-being similarities among adolescents.

  11. Task assignment and coaching

    NARCIS (Netherlands)

    Dominguez-Martinez, S.

    2009-01-01

    An important task of a manager is to motivate her subordinates. One way in which a manager can give incentives to junior employees is through the assignment of tasks. How a manager allocates tasks in an organization, provides information to the junior employees about his ability. Without coaching

  12. Imaging gastric structuring of lipid emulsions and its effect on gastrointestinal function: a randomized trial in healthy subjects.

    Science.gov (United States)

    Steingoetter, Andreas; Radovic, Tijana; Buetikofer, Simon; Curcic, Jelena; Menne, Dieter; Fried, Michael; Schwizer, Werner; Wooster, Tim J

    2015-04-01

    Efficient fat digestion requires fat processing within the stomach and fat sensing in the intestine. Both processes also control gastric emptying and gastrointestinal secretions. We aimed to visualize the influence of the intragastric stability of fat emulsions on their dynamics of gastric processing and structuring and to assess the effect this has on gastrointestinal motor and secretory functions. Eighteen healthy subjects with normal body mass index (BMI) were studied on 4 separate occasions in a double-blind, randomized, crossover design. Magnetic resonance imaging (MRI) data of the gastrointestinal tract and blood triglycerides were recorded before and for 240 min after the consumption of the following 4 different fat emulsions: lipid emulsion 1 (LE1; acid stable, 0.33 μm), lipid emulsion 2 (LE2; acid stable, 52 μm), lipid emulsion 3 (LE3; acid unstable, solid fat, 0.32 μm), and lipid emulsion 4 (LE4; acid unstable, liquid fat, 0.38 μm). Intragastric emulsion instability was associated with a change in gastric emptying. Acid-unstable emulsions exhibited biphasic and faster emptying profiles than did the 2 acid-stable emulsions (P ≤ 0.0001). When combined with solid fat (LE3), different dynamics of postprandial gallbladder volume were induced (P ≤ 0.001). For acid-stable emulsions, a reduction of droplet size by 2 orders of magnitude [LE1 (0.33 μm) compared with LE2 (52 μm)] delayed gastric emptying by 38 min. Although acid-stable (LE1 and LE2) and redispersible (LE4) emulsions caused a constant increase in blood triglycerides, no increase was detectable for LE3 (P emulsions. The acute effects of lipid emulsions on gastric emptying, gallbladder volume, and triglyceride absorption are dependent on microstructural changes undergone during consumption. Gastric peristalsis and secretion were effective at redispersing pools of liquid fat in the stomach. This trial was registered at clinicaltrials.gov as NCT01253005. © 2015 American Society for Nutrition.

  13. On pole structure assignment in linear systems

    Czech Academy of Sciences Publication Activity Database

    Loiseau, J.-J.; Zagalak, Petr

    2009-01-01

    Roč. 82, č. 7 (2009), s. 1179-1192 ISSN 0020-7179 R&D Projects: GA ČR(CZ) GA102/07/1596 Institutional research plan: CEZ:AV0Z10750506 Keywords : linear systems * linear state feedback * pole structure assignment Subject RIV: BC - Control Systems Theory Impact factor: 1.124, year: 2009 http://library.utia.cas.cz/separaty/2009/AS/zagalak-on pole structure assignment in linear systems.pdf

  14. Gain weighted eigenspace assignment

    Science.gov (United States)

    Davidson, John B.; Andrisani, Dominick, II

    1994-01-01

    This report presents the development of the gain weighted eigenspace assignment methodology. This provides a designer with a systematic methodology for trading off eigenvector placement versus gain magnitudes, while still maintaining desired closed-loop eigenvalue locations. This is accomplished by forming a cost function composed of a scalar measure of error between desired and achievable eigenvectors and a scalar measure of gain magnitude, determining analytical expressions for the gradients, and solving for the optimal solution by numerical iteration. For this development the scalar measure of gain magnitude is chosen to be a weighted sum of the squares of all the individual elements of the feedback gain matrix. An example is presented to demonstrate the method. In this example, solutions yielding achievable eigenvectors close to the desired eigenvectors are obtained with significant reductions in gain magnitude compared to a solution obtained using a previously developed eigenspace (eigenstructure) assignment method.

  15. Data on the recurrence of breast tumors fit a model in which dormant cells are subject to slow attrition but can randomly awaken to become malignant

    DEFF Research Database (Denmark)

    Stein, Wilfred D; Litman, Thomas

    2006-01-01

    by the body's immune system, or by random apoptosis or senescence. (iv) Recurrence suppressor mechanisms exist. (v) When such genes are disabled by random mutations, the dormant metastatic cell is activated, and will develop to a cancer recurrence. The model was also fitted to data on the survival......We successfully modeled the recurrence of tumors in breast cancer patients, assuming that: (i) A breast cancer patient is likely to have some circulating metastatic cells, even after initial surgery. (ii) These metastatic cells are dormant. (iii) The dormant cells are subject to attrition...

  16. Assignment Tracking Android Application

    OpenAIRE

    Akanni, Feranmi Timothy

    2016-01-01

    One of the common ways of checking that knowledge is impacted into students at every level of education is by giving various tasks to students and part of the responsibilities of the teacher is to give assignments to students and check the solution provided by the students. Increase in technology development involves a number of mobile applications that are being developed and released on a daily basis, out of which Android operating application is one of the dominant mobile application. T...

  17. Task assignment and coaching

    OpenAIRE

    Dominguez-Martinez, S.

    2009-01-01

    An important task of a manager is to motivate her subordinates. One way in which a manager can give incentives to junior employees is through the assignment of tasks. How a manager allocates tasks in an organization, provides information to the junior employees about his ability. Without coaching from a manager, the junior employee only has information about his past performance. Based on his past performance, a talented junior who has performed a difficult task sometimes decides to leave the...

  18. Responses to high-fat challenges varying in fat type in subjects with different metabolic risk phenotypes: a randomized trial

    NARCIS (Netherlands)

    Dijk, van S.J.; Mensink, M.R.; Esser, D.; Feskens, E.J.M.; Muller, M.R.; Afman, L.A.

    2012-01-01

    Background The ability of subjects to respond to nutritional challenges can reflect the flexibility of their biological system. Nutritional challenge tests could be used as an indicator of health status but more knowledge on metabolic and immune responses of different subjects to nutritional

  19. Long-term risk of carotid restenosis in patients randomly assigned to endovascular treatment or endarterectomy in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): long-term follow-up of a randomised trial.

    LENUS (Irish Health Repository)

    Bonati, Leo H

    2009-10-01

    In the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS), early recurrent carotid stenosis was more common in patients assigned to endovascular treatment than it was in patients assigned to endarterectomy (CEA), raising concerns about the long-term effectiveness of endovascular treatment. We aimed to investigate the long-term risks of restenosis in patients included in CAVATAS.

  20. Comparison of the effects on dynamic balance and aerobic capacity between objective and subjective methods of high-intensity robot-assisted gait training in chronic stroke patients: a randomized controlled trial.

    Science.gov (United States)

    Bae, Young-Hyeon; Lee, Suk Min; Ko, Mansoo

    2017-05-01

    Robot-assisted gait training (RAGT) is effective for improving dynamic balance and aerobic capacity, but previous RAGT method does not set suitable training intensity. Recently, high-intensity treadmill gait training at 70% of heart rate reserve (HRR) was used for improving aerobic capacity and dynamic balance. This study was designed to compare the effectiveness between objective and subjective methods of high-intensity RAGT for improving dynamic balance and aerobic capacity in chronic stroke. Subjects were randomly allocated into experimental (n = 17) and control (n = 17) groups. The experimental group underwent high-intensity RAGT at 70% of HRR, whereas the control group underwent high-intensity RAGT at an RPE of 15. Both groups received their assigned training for 30 min per session, 3 days per week for 6 weeks. All subjects also received an additional 30 min of conventional physical therapy. Before and after each of the 18 sessions, the dynamic balance and aerobic capacity of all subjects were evaluated by a blinded examiner. After training, Berg Balance Scale (BBS) and Timed Up and Go Test scores, VO2max, and VO2max/kg were significantly increased in both groups (p high-intensity RAGT. No adverse effect of training was observed in both groups. High-intensity RAGT at 70% of HRR significantly improved dynamic balance and aerobic capacity more than RAGT at RPE of 15. These results suggest that high-intensity RAGT at 70% of HRR is safe and effective for improving dynamic balance and aerobic capacity in chronic stroke.

  1. 75 FR 55354 - Delegation of Authority and Assignment of Responsibilities

    Science.gov (United States)

    2010-09-10

    ... of the Secretary Delegation of Authority and Assignment of Responsibilities Secretary's Order 3-2010 Subject: Delegation of Authority and Assignment of Responsibilities to the Employee Benefits Security Administration. 1. Purpose. To delegate authority and assign responsibilities for the administration of the...

  2. Dry cupping for plantar fasciitis: a randomized controlled trial

    OpenAIRE

    Ge, Weiqing; Leson, Chelsea; Vukovic, Corey

    2017-01-01

    [Purpose] The purpose of this study was to determine the effects of dry cupping on pain and function of patients with plantar fasciitis. [Subjects and Methods] Twenty-nine subjects (age 15 to 59?years old, 20 females and 9 males), randomly assigned into the two groups (dry cupping therapy and electrical stimulation therapy groups), participated in this study. The research design was a randomized controlled trial (RCT). Treatments were provided to the subjects twice a week for 4 weeks. Outcome...

  3. Low-dose ticagrelor yields an antiplatelet efficacy similar to that of standard-dose ticagrelor in healthy subjects: an open-label randomized controlled trial

    OpenAIRE

    Pan Li; Ying Gu; Yawei Yang; Lizhi Chen; Junmei Liu; Lihong Gao; Yongwen Qin; Quancai Cai; Xianxian Zhao; Zhuo Wang; Liping Ma

    2016-01-01

    Ticagrelor has a greater antiplatelet efficacy than clopidogrel but may be accompanied by an increased risk of bleeding. This study evaluated the antiplatelet effect and pharmacokinetic profile of low-dose ticagrelor in healthy Chinese volunteers. Thirty healthy subjects were randomized to receive standard-dose ticagrelor (180-mg loading dose, 90-mg twice daily [bid] [n?=?10]), low-dose ticagrelor (90-mg loading dose, 45-mg bid [n?=?10]), or clopidogrel (600-mg loading dose, 75-mg once daily ...

  4. Approximate Forward Difference Equations for the Lower Order Non-Stationary Statistics of Geometrically Non-Linear Systems subject to Random Excitation

    DEFF Research Database (Denmark)

    Köylüoglu, H. U.; Nielsen, Søren R. K.; Cakmak, A. S.

    Geometrically non-linear multi-degree-of-freedom (MDOF) systems subject to random excitation are considered. New semi-analytical approximate forward difference equations for the lower order non-stationary statistical moments of the response are derived from the stochastic differential equations...... of motion, and, the accuracy of these equations is numerically investigated. For stationary excitations, the proposed method computes the stationary statistical moments of the response from the solution of non-linear algebraic equations....

  5. Happy Family Kitchen II: a cluster randomized controlled trial of a community-based positive psychology family intervention for subjective happiness and health-related quality of life in Hong Kong.

    Science.gov (United States)

    Ho, Henry C Y; Mui, Moses; Wan, Alice; Ng, Yin-Lam; Stewart, Sunita M; Yew, Carol; Lam, Tai Hing; Chan, Sophia S

    2016-07-29

    Most positive psychology interventions conducted in the West have been focused on the individual. Family relationships are highly valued in the Chinese collectivist culture, and it is of interest to know whether family-focused interventions can improve the well-being of Chinese people. We have previously reported the effectiveness of a positive psychology family intervention in terms of family well-being. Based on the data derived from the Happy Family Kitchen II project, this paper examines the effectiveness of a community-based positive psychology family intervention on subjective happiness and health-related quality of life. Thirty-one social service units and schools organized intervention programs for 2070 participants in Hong Kong. In a cluster randomized controlled trial, participants were randomly assigned on the basis of computer-generated numbers into the intervention group or the control group. The intervention programs emphasized one of five positive psychology themes: joy, gratitude, flow, savoring, and listening. The control group engaged in activities unrelated to the intervention, such as arts and crafts workshops. Subjective happiness and mental and physical quality of life were assessed at baseline and at 4 weeks and 12 weeks postintervention. Data of 1261 participants were analyzed. The results showed that the intervention was more effective than the control condition in improving subjective happiness, with a small effect size, at 12 weeks postintervention (β = .15, p = .020, Cohen's d = .16). However, there were no improvements in mental and physical quality of life in the intervention group compared with the control group at 4 weeks (β = .39, p = .494, d = .05; β = -.10, p = 1.000, d = -.01, respectively) and 12 weeks postintervention (β = .71, p = .233, d = .08; β = -.05, p = 1.000, d = -.01, respectively). Furthermore, the booster session was no more effective than the tea

  6. Relative bioavailability of tizanidine 4-mg capsule and tablet formulations after a standardized high-fat meal: a single-dose, randomized, open-label, crossover study in healthy subjects.

    Science.gov (United States)

    Henney, Herbert R; Shah, Jaymin

    2007-04-01

    An immediate-release, multiparticulate capsule formulation of tizanidine has been developed to modify tizanidine pharmacokinetic characteristics in an attempt to decrease adverse events (AEs) while maintaining effectiveness in the management of spasticity. This study was designed to compare the pharmacokinetic properties and tolerability of a single dose (4 mg) of an immediate-release, multiparticulate tizanidine capsule versus a commercially available tablet (reference) administered after a standardized high-fat meal. This single-dose, randomized, open-label, 2-way crossover study in healthy, nonsmoking adult subjects was conducted at MDS Pharma Services, Belfast, United Kingdom. Subjects were randomly assigned to receive the capsule-tablet or tablet-capsule treatment. The 2 treatment periods were separated by a 6-day washout period. All treatments were administered after a standardized high-fat meal. To determine plasma tizanidine pharmacokinetic properties, blood samples were collected over 24 hours after administration. The predetermined bioequivalence range for the test drug (capsule) was 80% to 125% of the reference drug (tablet). Drug tolerability was assessed using routine physical examination, including vital-sign measurements; laboratory analysis (hematology, biochemistry, and urinalysis); 12-lead electrocardiography; direct observation; spontaneous reporting; and non specific questioning. This study included 18 subjects (12 men, 6 women; mean [SD] age, 26 [7] years). The mean height and body weight of the subjects were 176 (8) cm and 70.1 (9.6) kg, respectively. The peak exposure, as measured by mean natural logarithm-transformed C(max) values, was significantly lower with the capsule compared with the tablet (2.7 vs 4.0 ng/mL; P definition of bioequivalence when given after a high-fat meal. All AEs were transient and mild in intensity, with asthenia being the most common event with the capsule and tablet formulations, occurring in 5 (28%) and 8 (44

  7. The Mulligan ankle taping does not affect balance performance in healthy subjects: a prospective, randomized blinded trial.

    Science.gov (United States)

    de-la-Morena, Jose Maria Delfa; Alguacil-Diego, Isabel Maria; Molina-Rueda, Francisco; Ramiro-González, Maria; Villafañe, Jorge Hugo; Fernández-Carnero, Josué

    2015-05-01

    [Purpose] The aim of this study was to evaluate the immediate effects of Mulligan fibular taping on static and dynamic postural balance in healthy subjects using computerized dynamic posturography (CDP). [Subjects and Methods] Forty-four volunteers (26 males and 18 females) aged 21 ±2 years participated in the study. The Mulligan tape was applied by a specialist in this technique. The placebo group received a treatment with a similar tape but with several cuts to avoid the fibular repositioning effect produced by Mulligan tape. The Sensory Organization Test (SOT) and the Motor Control Test (MCT) were performed by each subject at baseline and after the interventions. Outcome measures included equilibrium and strategy scores from each trial and condition of the SOT, and speed of reaction (latency period) from the MCT. [Results] Mulligan ankle taping did not have an impact on postural control during static and dynamic balance in subjects with healthy ankles when compared with placebo taping. [Conclusion] There was no difference in, equilibrium and strategy (SOT) and speed of reaction (MCT) in any of the subjects in this study. Therefore, this study suggests that Mulligan ankle taping does not have an impact on balance in healthy subjects.

  8. Responses to high-fat challenges varying in fat type in subjects with different metabolic risk phenotypes: a randomized trial.

    Directory of Open Access Journals (Sweden)

    Susan J van Dijk

    Full Text Available The ability of subjects to respond to nutritional challenges can reflect the flexibility of their biological system. Nutritional challenge tests could be used as an indicator of health status but more knowledge on metabolic and immune responses of different subjects to nutritional challenges is needed. The aim of this study was to compare the responses to high-fat challenges varying in fat type in subjects with different metabolic risk phenotypes.In a cross-over design 42 men (age 50-70 y consumed three high-fat shakes containing saturated fat (SFA, monounsaturated fat (MUFA or n-3 polyunsaturated (PUFA. Men were selected on BMI and health status (lean, obese or obese diabetic and phenotyped with MRI for adipose tissue distribution. Before and 2 and 4 h after shake consumption blood was drawn for measurement of expression of metabolic and inflammation-related genes in peripheral blood mononuclear cells (PBMCs, plasma triglycerides (TAG, glucose, insulin, cytokines and ex vivo PBMC immune response capacity. The MUFA and n-3 PUFA challenge, compared to the SFA challenge, induced higher changes in expression of inflammation genes MCP1 and IL1β in PBMCs. Obese and obese diabetic subjects had different PBMC gene expression and metabolic responses to high-fat challenges compared to lean subjects. The MUFA challenge induced the most pronounced TAG response, mainly in obese and obese diabetic subjects.The PBMC gene expression response and metabolic response to high-fat challenges were affected by fat type and metabolic risk phenotype. Based on our results we suggest using a MUFA challenge to reveal differences in response capacity of subjects.ClinicalTrials.gov NCT00977262.

  9. Japan Diabetes Outcome Intervention Trial-1(J-DOIT1, a nationwide cluster randomized trial of type 2 diabetes prevention by telephone-delivered lifestyle support for high-risk subjects detected at health checkups: rationale, design, and recruitment

    Directory of Open Access Journals (Sweden)

    Sakane Naoki

    2013-01-01

    Full Text Available Abstract Background Lifestyle modifications are considered the most effective means of delaying or preventing the development of type 2 diabetes (T2DM. To contain the growing population of T2DM, it is critical to clarify effective and efficient settings for intervention and modalities for intervention delivery with a wide population reach. The Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1 is a cluster randomized controlled trial to test whether goal-focused lifestyle coaching delivered by telephone can prevent the development of T2DM in high-risk individuals in a real-world setting. This paper describes the study design and recruitment of the study subjects. Methods For the recruitment of study subjects and their follow-up annually over 3 years, we employed health checkups conducted annually at communities and worksites. Health care divisions recruited from communities and companies across Japan formed groups as a cluster randomization unit. Candidates for the study, aged 20-65 years with fasting plasma glucose (FPG of 5.6-6.9 mmol/l, were recruited from each group using health checkups results in 2006. Goal-focused lifestyle support is delivered by healthcare providers via telephone over a one-year period. Study subjects will be followed-up for three years by annual health checkups. Primary outcome is the development of diabetes defined as FPG≥7.0 mmol/l on annual health checkup or based on self-report, which is confirmed by referring to medical cards. Results Forty-three groups (clusters, formed from 17 health care divisions, were randomly assigned to an intervention arm (22 groups or control arm (21 clusters between March 2007 and February 2008. A total of 2840 participants, 1336 from the intervention and 1504 from the control arm, were recruited. Consent rate was about 20%, with no difference between the intervention and control arms. There were no differences in cluster size and characteristics of cluster between the groups. There

  10. Japan Diabetes Outcome Intervention Trial-1(J-DOIT1), a nationwide cluster randomized trial of type 2 diabetes prevention by telephone-delivered lifestyle support for high-risk subjects detected at health checkups: rationale, design, and recruitment

    Science.gov (United States)

    2013-01-01

    Background Lifestyle modifications are considered the most effective means of delaying or preventing the development of type 2 diabetes (T2DM). To contain the growing population of T2DM, it is critical to clarify effective and efficient settings for intervention and modalities for intervention delivery with a wide population reach. The Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1) is a cluster randomized controlled trial to test whether goal-focused lifestyle coaching delivered by telephone can prevent the development of T2DM in high-risk individuals in a real-world setting. This paper describes the study design and recruitment of the study subjects. Methods For the recruitment of study subjects and their follow-up annually over 3 years, we employed health checkups conducted annually at communities and worksites. Health care divisions recruited from communities and companies across Japan formed groups as a cluster randomization unit. Candidates for the study, aged 20-65 years with fasting plasma glucose (FPG) of 5.6-6.9 mmol/l, were recruited from each group using health checkups results in 2006. Goal-focused lifestyle support is delivered by healthcare providers via telephone over a one-year period. Study subjects will be followed-up for three years by annual health checkups. Primary outcome is the development of diabetes defined as FPG≥7.0 mmol/l on annual health checkup or based on self-report, which is confirmed by referring to medical cards. Results Forty-three groups (clusters), formed from 17 health care divisions, were randomly assigned to an intervention arm (22 groups) or control arm (21 clusters) between March 2007 and February 2008. A total of 2840 participants, 1336 from the intervention and 1504 from the control arm, were recruited. Consent rate was about 20%, with no difference between the intervention and control arms. There were no differences in cluster size and characteristics of cluster between the groups. There were no differences in

  11. Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1), a nationwide cluster randomized trial of type 2 diabetes prevention by telephone-delivered lifestyle support for high-risk subjects detected at health checkups: rationale, design, and recruitment.

    Science.gov (United States)

    Sakane, Naoki; Kotani, Kazuhiko; Takahashi, Kaoru; Sano, Yoshiko; Tsuzaki, Kokoro; Okazaki, Kentaro; Sato, Juichi; Suzuki, Sadao; Morita, Satoshi; Izumi, Kazuo; Kato, Masayuki; Ishizuka, Naoki; Noda, Mitsuhiko; Kuzuya, Hideshi

    2013-01-29

    Lifestyle modifications are considered the most effective means of delaying or preventing the development of type 2 diabetes (T2DM). To contain the growing population of T2DM, it is critical to clarify effective and efficient settings for intervention and modalities for intervention delivery with a wide population reach.The Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1) is a cluster randomized controlled trial to test whether goal-focused lifestyle coaching delivered by telephone can prevent the development of T2DM in high-risk individuals in a real-world setting. This paper describes the study design and recruitment of the study subjects. For the recruitment of study subjects and their follow-up annually over 3 years, we employed health checkups conducted annually at communities and worksites. Health care divisions recruited from communities and companies across Japan formed groups as a cluster randomization unit. Candidates for the study, aged 20-65 years with fasting plasma glucose (FPG) of 5.6-6.9 mmol/l, were recruited from each group using health checkups results in 2006. Goal-focused lifestyle support is delivered by healthcare providers via telephone over a one-year period. Study subjects will be followed-up for three years by annual health checkups. Primary outcome is the development of diabetes defined as FPG≥7.0 mmol/l on annual health checkup or based on self-report, which is confirmed by referring to medical cards. Forty-three groups (clusters), formed from 17 health care divisions, were randomly assigned to an intervention arm (22 groups) or control arm (21 clusters) between March 2007 and February 2008. A total of 2840 participants, 1336 from the intervention and 1504 from the control arm, were recruited. Consent rate was about 20%, with no difference between the intervention and control arms. There were no differences in cluster size and characteristics of cluster between the groups. There were no differences in individual characteristics

  12. Effect of Oral Coadministration of Ascorbic Acid with Ling Zhi Preparation on Pharmacokinetics of Ganoderic Acid A in Healthy Male Subjects: A Randomized Crossover Study

    Science.gov (United States)

    Tawasri, Patcharanee; Ampasavate, Chadarat; Tharatha, Somsak

    2016-01-01

    The objective of this randomized, open-label, single-dose, two-phase crossover study was to determine the effect of ascorbic acid on pharmacokinetics of ganoderic acid A, an important biologically active triterpenoid compound with anticancer activities, following oral administration of water extract of fruiting bodies of Ling Zhi in 12 healthy male subjects. Each subject was randomized to receive either one of the two regimens: (1) a single dose of 3,000 mg of the Ling Zhi preparation or (2) a single dose of 3,000 mg of the Ling Zhi preparation in combination with 2,500 mg of ascorbic acid. After a washout period of at least two weeks, subjects were switched to receive the alternate regimen. Blood samples were collected in each phase immediately before dosing and at specific time points for 8 hours after dosing. Plasma ganoderic acid A concentrations were quantified using liquid chromatography-mass spectrometry (LC-MS). The pharmacokinetic parameters analyzed were maximal plasma concentration (C max), time to reach peak concentration (T max), area under the plasma concentration-time curve (AUC), and half-life (t 1/2). An oral coadministration of ascorbic acid with Ling Zhi preparation did not significantly alter the pharmacokinetic parameters of ganoderic acid A in healthy male subjects. PMID:27747224

  13. Effects of oral α-lipoic acid administration on body weight in overweight or obese subjects: a crossover randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Li, Nong; Yan, Weili; Hu, Xiaojuan; Huang, Yongdi; Wang, Fugang; Zhang, Weiguo; Wang, Qian; Wang, Xiaoling; Sun, Kehong

    2017-05-01

    Alpha-lipoic acid (ALA) has shown beneficial properties on diabetes and obesity. The aim of this study was to examine the effects of oral ALA on body weight in subjects with overweight or obese. Single-centre, randomized, double-blind, crossover controlled study. A total of 166 subjects of Chinese Han ethnicity with a BMI ≥25 kg/m2 were screened and 103 subjects fulfilled the study requirements, in terms of informed consent and participation to the study. The subjects were randomized (1:1) to receive either ALA (1200 mg/day) or placebo treatment in a crossover design for 8 weeks. The primary end-point was the change in body weight. The secondary end-points were the changes in waist circumference, BMI, lipid profile, plasma leptin levels and the adverse events that occurred following ALA treatment. The changes in the body weight and waist circumference noted in the ALA group were significantly different compared to the placebo group as demonstrated by mixed model statistical analysis (both P weight reduction was seen in the ALA group, and no significant differences were noted as regards cholesterol levels, triglyceride levels, high-density lipoprotein cholesterol levels and adverse events between the two groups. The administration of ALA was well tolerated, and no serious adverse events were noted. Oral administration of ALA (1200 mg/day) for 8 weeks induced mild weight loss accompanied by a reduction in waist circumference. © 2017 John Wiley & Sons Ltd.

  14. Randomized, multi-center trial of two hypo-energetic diets in obese subjects: high- versus low-fat content

    DEFF Research Database (Denmark)

    Petersen, M; Taylor, M A; Saris, W H M

    2006-01-01

    OBJECTIVE: To investigate whether a hypo-energetic low-fat diet is superior to a hypo-energetic high-fat diet for the treatment of obesity. DESIGN: Open-label, 10-week dietary intervention comparing two hypo-energetic (-600 kcal/day) diets with a fat energy percent of 20-25 or 40-45.Subjects......:Obese (BMI >or=30 kg/m(2)) adult subjects (n = 771), from eight European centers. MEASUREMENTS: Body weight loss, dropout rates, proportion of subjects who lost more than 10% of initial body weight, blood lipid profile, insulin and glucose. RESULTS: The dietary fat energy percent was 25% in the low-fat group...

  15. A randomized crossover study to evaluate LDL-cholesterol lowering effect of a generic product of simvastatin (Unison Company) compared to simvastatin (Zocor) in hypercholesterolemic subjects.

    Science.gov (United States)

    Assawawitoontip, Surin; Wiwanitkit, Viroj

    2002-06-01

    It is agreed that people with a high blood LDL-cholesterol level will have a higher risk of coronary heart disease (CAD) than those with low blood LDL-cholesterol level. Because of the present National Drug Strategy of Thailand, the promotion of "in-country production" of a generic drug has been established. Simvastatin is one of the drugs in this strategy. In this, the primary report of a randomized crossover study with washout period for a cholesterol lowering effect in a generic product of simvastatin (Unison company) which was compared to the original simvastatin (Zocor) hypercholesterolemic to the subjects were presented. Simvastatin used in this study were derived from two sources. The first group was the original product (Zocor), dosage 10 mg, Lot No IC4/36(N) from Merck Sharp & Dohme Company and the second group was a generic product, dosage 10 mg, Lot No T05/080 and T06/109 from Unison Company. All simvastatin tablets from the first and second sources were inserted into closed capsule of the same shape and called drug A and drug B, respectively. Both the physician in-charge and the subjects in this study were blinded for the content inside the capsule (Double blind). Thirty drug capsules were put into a sachet and distributed to the subject at each visit. The interval between each visit was 4 weeks. All subjects were asked to bring back the residual capsule within the sachet to the researcher at each visit in order to evaluate the subject's compliance. All subjects had physical examination and blood tests at each visit. Furthermore, all subjects were advised to practice diet control and regular in-take of the drug capsule daily after their evening meal. All 48 subjects were randomly allocated into 2 groups. This study was run as a randomized crossover study. After taking the drugs for the first 8 weeks, no statistically significant difference of blood LDL-cholesterol between the first and second group was detected. After a 4 week washout period, crossover

  16. Practice-based randomized controlled-comparison clinical trial of chiropractic adjustments and brief massage treatment at sites of subluxation in subjects with essential hypertension: pilot study.

    Science.gov (United States)

    Plaugher, Gregory; Long, Cynthia R; Alcantara, Joel; Silveus, Alyssa D; Wood, Herbert; Lotun, Kapildeo; Menke, J Michael; Meeker, William C; Rowe, Stephen H

    2002-05-01

    To determine the feasibility of conducting a randomized clinical trial in the private practice setting examining short- and long-term effects of chiropractic adjustments for subjects with essential hypertension compared with a brief soft tissue massage, as well as a nontreatment control group. Randomized controlled-comparison trial with 3 parallel groups. Private practice outpatient chiropractic clinic. Twenty-three subjects, aged 24 to 50 years with systolic or diastolic essential hypertension. Two months of full-spine chiropractic care (ie, Gonstead) consisting primarily of specific-contact, short-lever-arm adjustments delivered at motion segments exhibiting signs of subluxation. The massage group had a brief effleurage procedure delivered at localized regions of the spine believed to be exhibiting signs of subluxation. The nontreatment control group rested alone for a period of approximately 5 minutes in an adjustment room. Cost per enrolled subject, as well as systolic and diastolic blood pressure (BP) measured with a random-0 sphygmomanometer and patient reported health status (SF-36). Pilot study outcome measures also included an assessment of cooperation of subjects to randomization procedures and drop-out rates, recruitment effectiveness, analysis of temporal stability of BPs at the beginning of care, and the effects of inclusion/exclusion criteria on the subject pool. Thirty subjects enrolled, yielding a cost of $161 per enrolled subject. One subject was later determined to be ineligible, and 6 others dropped out. In both the chiropractic and massage therapy groups, all subjects were classified as either overweight or obese; in the control group there were only 2 classified as such. SF-36 profiles for the groups were similar to that of a normal population. The mean change in diastolic BP was -4 (95% confidence interval [CI]: -8.6, 0.5) in the chiropractic care group, 0.5 (95% CI: -3.5, 4.5) in the brief massage treatment group, and -4.9 (95% CI: -9.7, -0

  17. Safety and tolerability of intravenous regadenoson in healthy subjects: A randomized, repeat-dose, placebo-controlled study

    OpenAIRE

    Townsend, Robert; Desai, Amit; Rammelsberg, Diane; Kowalski, Donna; Simmons, Neal; Kitt, Therese M.

    2015-01-01

    Background Regadenoson is a selective A2A adenosine receptor agonist indicated for radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. However, the safety, tolerability, and plasma concentrations associated with repeated doses have not previously been assessed. Method and Results Healthy males and females were randomized to receive intravenous regadenoson [100??g (3 doses), 200??g (3 doses), or 400??g (2 doses)], or placebo (2 or 3 doses; 0.9% sod...

  18. Subjective Well-Being and the Family: Results from an Ordered Probit Model with Multiple Random Effects

    OpenAIRE

    Winkelmann, Rainer

    2004-01-01

    The previous literature on the determinants of individual well-being has failed to fully account for the interdependencies in well-being at the family level. This paper develops an ordered probit model with multiple random effects that allows to identify the intrafamily correlation in well-being. The parameters of the model can be estimated with panel data using Maximum Marginal Likelihood. The approach is illustrated in an application using panel data for the period 1984-1997 from the German...

  19. Resveratrol as Add-on Therapy in Subjects With Well-Controlled Type 2 Diabetes: A Randomized Controlled Trial.

    NARCIS (Netherlands)

    Timmers, S.; Ligt, M. de; Phielix, E.; Weijer, T. van de; Hansen, J.; Moonen-Kornips, E.; Schaart, G.; Kunz, I.; Hesselink, M.K.; Schrauwen-Hinderling, V.B.; Schrauwen, P.

    2016-01-01

    OBJECTIVE: To determine whether resveratrol supplementation can improve insulin sensitivity and promote overall metabolic health on top of standard diabetes care. RESEARCH DESIGN AND METHODS: Seventeen subjects with well-controlled type 2 diabetes (T2D) were treated with placebo and 150 mg/day

  20. Effect of oral magnesium supplementation on measures of airway resistance and subjective assessment of asthma control and quality of life in men and women with mild to moderate asthma: a randomized placebo controlled trial.

    Science.gov (United States)

    Kazaks, Alexandra G; Uriu-Adams, Janet Y; Albertson, Timothy E; Shenoy, Sonia F; Stern, Judith S

    2010-02-01

    Epidemiological data shows low dietary magnesium(Mg) may be related to incidence and progression of asthma. To determine if long term(6.5 month) treatment with oral Mg would improve asthma control and increase serum measures of Mg status in men and women with mild-to-moderate asthma. 55 males and females aged 21 to 55 years with mild to moderate asthma according to the 2002 National Heart, Lung, and Blood Institute(NHLBI) and Asthma Education and Prevention Program(NAEPP) guidelines and who used only beta-agonists or inhaled corticosteroids(ICS) as asthma medications were enrolled. Subjects were randomly assigned to consume 340 mg(170 mg twice a day) of Mg or a placebo for 6.5 months. Multiple measures of Mg status including serum, erythrocyte, urine, dietary, ionized and IV Mg were measured. markers of asthma control were: methacholine challenge test(MCCT) and pulmonary function test(PFT) results. Subjective validated questionnaires on asthma quality of life(AQLQ) and control(ACQ) were completed by participants. Markers of inflammation, including c-reactive protein(CRP) and exhaled nitric oxide(eNO) were determined. The concentration of methacholine required to cause a 20% drop in forced expiratory volume in in minute(FEV(1)) increased significantly from baseline to month 6 within the Mg group. Peak expiratory flow rate(PEFR) showed a 5.8% predicted improvement over time(P = 0.03) in those consuming the Mg. There was significant improvement in AQLQ mean score units(P reactivity to methacholine and PEFR and in subjective measures of asthma control and quality of life.

  1. Bioavailability of two oral suspension and two oral tablet formulations of acyclovir 400 mg: two single-dose, open-label, randomized, two-period crossover comparisons in healthy Mexican adult subjects.

    Science.gov (United States)

    Palma-Aguirre, Jose Antonio; Absalón-Reyes, Jose Antonio; Novoa-Heckel, Germán; de Lago, Alberto; Oliva, Iván; Rodríguez, Zulema; González-de la Parra, Mario; Burke-Fraga, Victoria; Namur, Salvador

    2007-06-01

    Acyclovir is an important antiviral drug, used extensively for treatment of herpes simplex and varicella zoster. Six oral generic formulations of acyclovir are available in Mexico; however, a literature search failed to identify data information concerning the bioavailability of these formulations in the Mexican population. The aim of these 2 studies was to compare the bioavailability of 4 oral formulations of acyclovir 400 mg--2 tablet formulations and 2 suspension formulations--with their corresponding listed drug references in Mexico (a list issued by Mexican Health Authorities). Two separate, single-dose, open-label, randomized, 2-period crossover studies were conducted at the Centro de Estudios Científicos y Clínicos Pharma, S.A. de C.V. (clinical unit), Mexico City, Mexico. For each study, a different set of eligible subjects were selected. They included healthy Mexican volunteers of either sex. For each study, subjects were randomly assigned to receive 1 test formulation of acyclovir 400 mg followed by the reference formulation, or vice versa, with a 1-week washout period between doses. After a 12-hour (overnight) fast, subjects received a single 400-mg dose (tablet or 10-mL suspension) of the corresponding formulation. For the analysis of pharmacokinetic properties, including C(max), AUC from time 0 (baseline) to time t (AUC(0-t)), and AUC from baseline to infinity (AUC(0-infinity)), blood samples were drawn at baseline, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, and 24 hours after dosing. The formulations were considered bioequivalent if the natural logarithm (ln)-transformed ratios of Cmax and AUC were within the predetermined equivalence range of 80% to 125% and if P healthy subjects, single, 400-mg doses of the test brand of acyclovir administered either in tablet or suspension form, appeared to be bioequivalent to the reference brand based on the rate and extent of absorption in accordance with the definition of the US Food and Drug

  2. Coleus forskohlii Extract Supplementation in Conjunction with a Hypocaloric Diet Reduces the Risk Factors of Metabolic Syndrome in Overweight and Obese Subjects: A Randomized Controlled Trial.

    Science.gov (United States)

    Loftus, Hayley L; Astell, Katie J; Mathai, Michael L; Su, Xiao Q

    2015-11-17

    Limited studies have shown that Coleus forskohlii extract may aid in weight management. This randomized, double blind placebo-controlled clinical study assessed the effects of supplementation with C. forskohlii extract on key markers of obesity and metabolic parameters in overweight and obese individuals. Thirty participants completed the trial and they were randomly assigned to receive either 250 mg of C. forskohlii extract (n = 15) or a placebo twice daily for 12 weeks. All participants were advised to follow a hypocaloric diet throughout the study. Body weight, body mass index (BMI), waist and hip circumference, and waist to hip ratio, were monitored fortnightly. Dietary intake was assessed at the baseline and weeks 4, 8 and 12. Appetite was assessed using visual analogue scales and blood samples were analyzed for plasma lipids, ghrelin, leptin, glucose and insulin at the baseline and end of the intervention. Significant reductions to waist and hip circumference (p = 0.02; p = 0.01, respectively) were recorded in both experimental and placebo groups after the 12 week intervention. Furthermore, high density lipoprotein-cholesterol (HDL-C) was significantly increased (p = 0.01) in both groups. The experimental group showed a favorable improvement in insulin concentration and insulin resistance (p = 0.001; 0.01 respectively) compared to the placebo group. These findings suggest that C. forskohlii extract in conjunction with a hypocaloric diet may be useful in the management of metabolic risk factors.

  3. Coleus forskohlii Extract Supplementation in Conjunction with a Hypocaloric Diet Reduces the Risk Factors of Metabolic Syndrome in Overweight and Obese Subjects: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Hayley L. Loftus

    2015-11-01

    Full Text Available Limited studies have shown that Coleus forskohlii extract may aid in weight management. This randomized, double blind placebo-controlled clinical study assessed the effects of supplementation with C. forskohlii extract on key markers of obesity and metabolic parameters in overweight and obese individuals. Thirty participants completed the trial and they were randomly assigned to receive either 250 mg of C. forskohlii extract (n = 15 or a placebo twice daily for 12 weeks. All participants were advised to follow a hypocaloric diet throughout the study. Body weight, body mass index (BMI, waist and hip circumference, and waist to hip ratio, were monitored fortnightly. Dietary intake was assessed at the baseline and weeks 4, 8 and 12. Appetite was assessed using visual analogue scales and blood samples were analyzed for plasma lipids, ghrelin, leptin, glucose and insulin at the baseline and end of the intervention. Significant reductions to waist and hip circumference (p = 0.02; p = 0.01, respectively were recorded in both experimental and placebo groups after the 12 week intervention. Furthermore, high density lipoprotein-cholesterol (HDL-C was significantly increased (p = 0.01 in both groups. The experimental group showed a favorable improvement in insulin concentration and insulin resistance (p = 0.001; 0.01 respectively compared to the placebo group. These findings suggest that C. forskohlii extract in conjunction with a hypocaloric diet may be useful in the management of metabolic risk factors.

  4. A randomized controlled trial: the effect of inulin on weight management and ectopic fat in subjects with prediabetes

    OpenAIRE

    Guess, ND; Dornhorst, A; Oliver, N; Bell, JD; Thomas, EL; Frost, GS

    2015-01-01

    Background Fat infiltration of the liver, muscle and pancreas is associated with insulin resistance and risk of diabetes. Weight loss reduces ectopic fat deposition and risk of diabetes, but is difficult to sustain to due to compensatory increases in appetite. Fermentable carbohydrates have been shown to decrease appetite and food intake, and promote weight loss in overweight subjects. In animal studies, fermentable carbohydrate reduces ectopic fat independent of weight loss. We aimed to inve...

  5. Effect of neuroscience education on subjects with chronic knee pain related to osteoarthritis: a randomized controlled trial

    OpenAIRE

    Lluch Girbés, Enrique Juan

    2017-01-01

    In this PhD study, the evidence for the role of central pain mechanisms in people with OA was investigated by means of a narrative and a systematic review of the existent literature. In addition, clinical criteria for recognizing central sensitization in subjects with knee OA are discussed as well as the rationale for a comprehensive integrative treatment program including pain neuroscience education and manual therapy for this population. Clinicians may find some practical problems when comb...

  6. Randomized, Controlled, Thorough QT/QTc Study Shows Absence of QT Prolongation with Luseogliflozin in Healthy Japanese Subjects.

    Directory of Open Access Journals (Sweden)

    Yuji Kumagai

    Full Text Available Luseogliflozin is a selective sodium glucose co-transporter 2 (SGLT2 inhibitor. To evaluate the cardiac safety of luseogliflozin, a thorough QT/QTc study was conducted in healthy Japanese subjects. The effects of moxifloxacin on QT prolongation in Japanese subjects were also evaluated. In this double-blind, placebo- and open-label positive-controlled, 4-way crossover study, 28 male and 28 female subjects received a single dose of luseogliflozin 5 mg (therapeutic dose, luseogliflozin 20 mg (supratherapeutic dose, placebo, and moxifloxacin 400 mg. Serial triplicate digital 12-lead electrocardiograms (ECGs were recorded before and after dosing, and results were analyzed using the Fridericia correction (QTcF method. Serial blood sampling was performed for pharmacokinetic analyses of luseogliflozin and moxifloxacin to analyze the relationship between QTcF interval and plasma concentration. The upper limits of the two-sided 90% confidence intervals (CIs for baseline and placebo-adjusted QTcF intervals (ΔΔQTcF in the 5 mg and 20 mg luseogliflozin groups were less than 10 ms at all time points. No correlation between plasma luseogliflozin concentrations and ΔΔQTcF was observed. In the moxifloxacin group, the lower limits of the two-sided 90% CIs for ΔΔQTcF were greater than 5 ms at all time points. A positive relationship was observed between plasma moxifloxacin concentration and change in ΔΔQTcF. Luseogliflozin was well tolerated at both dose levels. The majority of adverse events were mild in severity, and no serious or life-threatening adverse events occurred. Neither therapeutic (5 mg nor supratherapeutic (20 mg doses of luseogliflozin affected QT prolongation in healthy Japanese subjects.

  7. An integrated production inventory model of deteriorating items subject to random machine breakdown with a stochastic repair time

    Directory of Open Access Journals (Sweden)

    Huynh Trung Luong

    2016-11-01

    Full Text Available In a continuous manufacturing environment where production and consumption occur simultaneously, one of the biggest challenges is the efficient management of production and inventory system. In order to manage the integrated production inventory system economically it is necessary to identify the optimal production time and the optimal production reorder point that either maximize the profit or minimize the cost. In addition, during production the process has to go through some natural phenomena like random breakdown of machine, deterioration of product over time, uncertainty in repair time that eventually create the possibility of shortage. In this situation, efficient management of inventory & production is crucial. This paper addresses the situation where a perishable (deteriorated product is manufactured and consumed simultaneously, the demand of this product is stable over the time, machine that produce the product also face random failure and the time to repair this machine is also uncertain. In order to describe this scenario more appropriately, the continuously reviewed Economic Production Quantity (EPQ model is considered in this research work. The main goal is to identify the optimal production uptime and the production reorder point that ultimately minimize the expected value of total cost consisting of machine setup, deterioration, inventory holding, shortage and corrective maintenance cost.

  8. A randomized, double-blind, placebo-controlled study of the safety and tolerance of regadenoson in subjects with stage 3 or 4 chronic kidney disease.

    Science.gov (United States)

    Ananthasubramaniam, Karthik; Weiss, Robert; McNutt, Bruce; Klauke, Barbara; Feaheny, Kathleen; Bukofzer, Stan

    2012-04-01

    The safety and tolerability of regadenoson, a pharmacologic stress agent that is excreted primarily by the kidneys, were examined in subjects with chronic kidney disease (CKD). This multicenter, double-blind, randomized, placebo-controlled study involved men and women, ≥18 years of age, with stage 3 or 4 [estimated glomerular filtration rate (eGFR) 30-59 mL/minute/1.73 m(2) and 15-29 mL/minute/1.73 m(2), respectively] CKD and known or suspected coronary artery disease. Subjects were randomized 2:1 to receive one 10-second intravenous injection of regadenoson 0.4 mg or placebo. The primary outcome measure was the frequency of serious adverse events over 24-h post-dose. The study included 432 subjects with stage 3 (regadenoson n = 287; placebo n = 145) and 72 with stage 4 (regadenoson n = 47; placebo n = 25) CKD. No serious adverse events or deaths were reported over 24-h post-dose. The overall adverse event incidence was higher with regadenoson than placebo (62.6% vs 21.2%; P regadenoson, headache (24.9% vs 7.1%), dyspnea (19.2% vs 0.6%), chest discomfort (14.7% vs 0.6%), nausea (14.7% vs 1.2%), flushing (12.0% vs 1.8%), and dizziness (9.6% vs 0.6%) occurred significantly more often (P regadenoson than placebo. There were no trends for clinically meaningful changes in eGFR from baseline to 24-h post-dose in subjects with stage 3 or 4 CKD. Regadenoson was not associated with any serious or unexpected adverse events in subjects with stage 3 or 4 CKD.

  9. A randomized, double-blind, placebo-controlled study assessing the safety and tolerability of regadenoson in subjects with asthma or chronic obstructive pulmonary disease.

    Science.gov (United States)

    Prenner, Bruce M; Bukofzer, Stan; Behm, Sarah; Feaheny, Kathleen; McNutt, Bruce E

    2012-08-01

    Adenosine receptor stress agents for myocardial perfusion imaging (MPI) may cause A(2B) and/or A(3) receptor-mediated bronchoconstriction, of particular concern to physicians testing patients with asthma or chronic obstructive pulmonary disease (COPD). A Phase 4, randomized, double-blind study (NCT00862641) assessed the safety of the selective A(2A) receptor agonist, regadenoson, compared with placebo in subjects with asthma or COPD who represented likely candidates for MPI. Overall, 356 and 176 subjects with asthma and 316 and 151 subjects with COPD received regadenoson and placebo, respectively. The percentage of subjects experiencing a >15% decrease in FEV(1) from baseline to any assessment up to 24 hours post-baseline was not statistically significantly different between the regadenoson and the placebo groups in the asthma or COPD stratum. Dyspnea, the most frequent respiratory adverse event, occurred with higher incidence (P regadenoson group than the placebo group in the asthma (10.7% vs 1.1%) and COPD (18.0% vs 2.6%) strata. No subjects experienced severe bronchoconstriction, although the occurrence of such reactions with adenosine receptor agonists cannot be ruled out, such that caution is advised. This information may be helpful to physicians selecting a pharmacologic stress agent for MPI in patients with asthma or COPD.

  10. Immediate Effects of Combining Local Techniques in the Craniomandibular Area and Hamstring Muscle Stretching in Subjects with Temporomandibular Disorders: A Randomized Controlled Study.

    Science.gov (United States)

    Rodriguez-Blanco, Cleofás; Cocera-Morata, Francisco Miguel; Heredia-Rizo, Alberto Marcos; Ricard, François; Almazán-Campos, Ginés; Oliva-Pascual-Vaca, Ángel

    2015-08-01

    To assess the immediate effects on vertical mouth opening, orofacial mechanosensitivity, and lumbar and suboccipital mobility after adding a myofascial induction technique to a multimodal protocol in subjects with temporomandibular disorders (TMD). A randomized and double-blind controlled trial was carried out. University-based physical therapy research clinic. Sixty subjects (35±11.22 years) with TMD, and restricted mobility of the mandibular condyles and the first cervical vertebrae, were recruited and randomized to either a control group (CG) (n=30) or an experimental group (EG) (n=30). The CG underwent a neuromuscular technique over the masseter muscles and passive hamstring muscle stretching. A suboccipital muscle inhibition technique was added to this protocol in the EG. Primary measurements were made of vertical mouth opening and pressure pain threshold of the masseter muscles. Secondary outcome measures included pressure algometry of the trigeminal nerve, suboccipital range of motion, and lumbar spine mobility, assessed with the sit-and-reach (SAR) test and lumbar forward bending. All evaluations were collected at baseline and immediately after intervention. In the intragroup comparison, the EG observed an increase in suboccipital flexion (p0.05). The inclusion of a myofascial induction maneuver in a protocol combining local (neuromuscular treatment) and distal techniques (hamstring stretching) in subjects with TMD has no impact on improving mouth opening, suboccipital and lumbar mobility, and orofacial sensitivity to mechanical pressure.

  11. Effects of Kinesio® Tape in low back muscle fatigue: randomized, controlled, doubled-blinded clinical trial on healthy subjects.

    Science.gov (United States)

    Álvarez-Álvarez, S; José, F García-Muro San; Rodríguez-Fernández, A L; Güeita-Rodríguez, J; Waller, B J

    2014-01-01

    Muscle fatigue of the trunk extensor musculature plays a considerable role in chronic low back pain (LBP). The underlying physiology of fatigue is complex and not fully understood. The Kinesio® Taping (KT) supports damaged structures while allowing mobility and at the same time may influence some of the mechanisms associated with muscle fatigue such as blood flow and proprioception. The aim of this study is to determine the influence of KT on the resistance to fatigue of the lumbar extensor musculature in a sample of young healthy subjects. A randomized, controlled, doubled-blinded clinical trial was conducted. Ninety nine healthy subjects were randomized in to the three arms of the study Kinesio® Tape (KT), placebo (P) and control (C). Directly after application of KT we measured lumbar extensor musculature endurance with the Biering-Sorensen test. Subjects and researchers were blinded to the intervention. Time achieved (seconds) was compared between groups with one-way ANOVA with confidence intervals of 95%. There were significant differences between the time achieved in the KT group versus the control group (p < 0.05). The placebo group performed better than the control group but worse than the KT group, these were not significant in either case. KT appears to improve the time to failure of the extensor muscle of the trunk obtained using the Biering-Sorensen test. These findings suggest that KT influences processes that lead to muscle fatigue and that KT could be effective in the management of LBP.

  12. Cocoa flavanol consumption improves cognitive function, blood pressure control, and metabolic profile in elderly subjects: the Cocoa, Cognition, and Aging (CoCoA) Study—a randomized controlled trial1234

    Science.gov (United States)

    Mastroiacovo, Daniela; Kwik-Uribe, Catherine; Grassi, Davide; Necozione, Stefano; Raffaele, Angelo; Pistacchio, Luana; Righetti, Roberta; Bocale, Raffaella; Lechiara, Maria Carmela; Marini, Carmine; Ferri, Claudio; Desideri, Giovambattista

    2015-01-01

    Background: Recent evidence has indicated that flavanol consumption may have many health benefits in humans, including improved cognitive activities. Objective: The aim was to evaluate the effect of flavanol consumption on cognitive performance in cognitively intact elderly subjects. Design: This was a double-blind, controlled, parallel-arm study conducted in 90 elderly individuals without clinical evidence of cognitive dysfunction who were randomly assigned to consume daily for 8 wk a drink containing 993 mg [high flavanol (HF)], 520 mg [intermediate flavanol (IF)], or 48 mg [low flavanol (LF)] cocoa flavanols (CFs). Cognitive function was assessed at baseline and after 8 wk by using the Mini-Mental State Examination (MMSE), the Trail Making Test (TMT) A and B, and the Verbal Fluency Test (VFT). Results: The changes in MMSE score in response to the 3 different treatments were not different. In contrast, there was a positive impact of the intervention on specific aspects of cognitive function. Mean changes (±SEs) in the time required to complete the TMT A and B after consumption of the HF (−8.6 ± 0.4 and −16.5 ± 0.8 s, respectively) and IF (−6.7 ± 0.5 and −14.2 ± 0.5 s, respectively) drinks significantly (P flavanols can support healthy cognitive function with age. This trial was registered at www.controlled-trials.com as ISRCTN68970511. PMID:25733639

  13. Cocoa flavanol consumption improves cognitive function, blood pressure control, and metabolic profile in elderly subjects: the Cocoa, Cognition, and Aging (CoCoA) Study--a randomized controlled trial.

    Science.gov (United States)

    Mastroiacovo, Daniela; Kwik-Uribe, Catherine; Grassi, Davide; Necozione, Stefano; Raffaele, Angelo; Pistacchio, Luana; Righetti, Roberta; Bocale, Raffaella; Lechiara, Maria Carmela; Marini, Carmine; Ferri, Claudio; Desideri, Giovambattista

    2015-03-01

    Recent evidence has indicated that flavanol consumption may have many health benefits in humans, including improved cognitive activities. The aim was to evaluate the effect of flavanol consumption on cognitive performance in cognitively intact elderly subjects. This was a double-blind, controlled, parallel-arm study conducted in 90 elderly individuals without clinical evidence of cognitive dysfunction who were randomly assigned to consume daily for 8 wk a drink containing 993 mg [high flavanol (HF)], 520 mg [intermediate flavanol (IF)], or 48 mg [low flavanol (LF)] cocoa flavanols (CFs). Cognitive function was assessed at baseline and after 8 wk by using the Mini-Mental State Examination (MMSE), the Trail Making Test (TMT) A and B, and the Verbal Fluency Test (VFT). The changes in MMSE score in response to the 3 different treatments were not different. In contrast, there was a positive impact of the intervention on specific aspects of cognitive function. Mean changes (±SEs) in the time required to complete the TMT A and B after consumption of the HF (-8.6 ± 0.4 and -16.5 ± 0.8 s, respectively) and IF (-6.7 ± 0.5 and -14.2 ± 0.5 s, respectively) drinks significantly (P flavanols can support healthy cognitive function with age. © 2015 American Society for Nutrition.

  14. Job Assignments under Moral Hazard

    DEFF Research Database (Denmark)

    Koch, Alexander; Nafziger, Julia

    Inefficient job assignments are usually explained with incomplete information about employees' abilities or contractual imperfections. We show that inefficient assignments arise even without uncertainty about the employee's ability and with complete contracts. Building on this result we provide...

  15. Effects of different segmental spinal stabilization exercise protocols on postural stability in asymptomatic subjects: randomized controlled trial.

    Science.gov (United States)

    Kaya, Derya Ozer; Ergun, Nevin; Hayran, Mutlu

    2012-01-01

    The aim was to assess and compare the postural stability effects of the "Progressive Dynamic Spine Stabilization Exercise Protocols" (PDSSEP) which were designed for different spinal segments. The asymptomatic, sedentary, and female volunteers (21.26 ± 1.30 years old) were allocated randomly into Cervical (n=22), Lumbar (n=21), Thoracic (n=20), Combined (n=20), and Control (n=21) Groups. All training groups participated into the related PDSSEP for six weeks, 3 days/week. The assessments were carried out at the baseline, after 6(th) week, and on the 12(th) week. "Tetrax Interactive Posturography and Balance System" (Tetrax System, Ramat Gan, Israel) was used to assess the overall postural stability (SI), weight distribution (WDI) and somatosensory reactions. "Kruskal Wallis Test" for the differences of the pre-6th weeks, pre-12(th) weeks within the groups, "Mann-Whitney U Test" for control and inter-group comparisons were used. The differences were observed for eyes closed SI, and WDI in head right rotated position (p< 0.05) between the baseline and after completing the programs. Eyes closed SI in solid surface was shown statistically different in Thoracic group in comparison to controls (p< 0.02). SI on soft surface, SI head left rotated position and somatosensory reactions with head flexed position improved in Thoracic Group at the 12(th) week (p< 0.01). WDI significantly improved in Cervical Group (p< 0.01). Thoracic spine can be considered as a hidden source for improving overall postural stability. It may be appropriate to focus on thoracic region in the kinetic chain for the treatment or training. A prospective randomized controlled trial, Level 1.

  16. Are blood pressure and diabetes additive or synergistic risk factors? outcome in 8494 subjects randomly recruited from 10 populations

    DEFF Research Database (Denmark)

    Sehestedt, Thomas; Hansen, Tine W; Li, Yan

    2011-01-01

    It remains unknown whether diabetes and high blood pressure (BP) are simply additive risk factors for cardiovascular outcome or whether they act synergistically and potentiate one another. We performed 24-h ambulatory BP monitoring in 8494 subjects (mean age, 54.6 years; 47.0% women; 6.9% diabetic...... as the reference group, the adjusted hazard ratios for the cardiovascular endpoint were 1.35 (95% confidence interval (CI), 0.87-2.11) for white-coat hypertension, 1.78 (95% CI, 1.22-2.60) for masked hypertension and 2.44 (95% CI, 1.92-3.11) for sustained hypertension. The hazard ratios for non-diabetic subjects...... were not different from those of diabetic patients (P-values for interaction, 0.09¿P¿0.72). In conclusion, in a large international population-based database, both diabetes mellitus and BP contributed equally to the risk of cardiovascular complications without evidence for a synergistic effect.Hypertension...

  17. Tissue Damage Markers after a Spinal Manipulation in Healthy Subjects: A Preliminary Report of a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    A. Achalandabaso

    2014-01-01

    Full Text Available Spinal manipulation (SM is a manual therapy technique frequently applied to treat musculoskeletal disorders because of its analgesic effects. It is defined by a manual procedure involving a directed impulse to move a joint past its physiologic range of movement (ROM. In this sense, to exceed the physiologic ROM of a joint could trigger tissue damage, which might represent an adverse effect associated with spinal manipulation. The present work tries to explore the presence of tissue damage associated with SM through the damage markers analysis. Thirty healthy subjects recruited at the University of Jaén were submitted to a placebo SM (control group; n=10, a single lower cervical manipulation (cervical group; n=10, and a thoracic manipulation (n=10. Before the intervention, blood samples were extracted and centrifuged to obtain plasma and serum. The procedure was repeated right after the intervention and two hours after the intervention. Tissue damage markers creatine phosphokinase (CPK, lactate dehydrogenase (LDH, C-reactive protein (CRP, troponin-I, myoglobin, neuron-specific enolase (NSE, and aldolase were determined in samples. Statistical analysis was performed through a 3×3 mixed-model ANOVA. Neither cervical manipulation nor thoracic manipulation did produce significant changes in the CPK, LDH, CRP, troponin-I, myoglobin, NSE, or aldolase blood levels. Our data suggest that the mechanical strain produced by SM seems to be innocuous to the joints and surrounding tissues in healthy subjects.

  18. Ticagrelor Does Not Inhibit Adenosine Transport at Relevant Concentrations: A Randomized Cross-Over Study in Healthy Subjects In Vivo.

    Directory of Open Access Journals (Sweden)

    T N A van den Berg

    Full Text Available In patients with myocardial infarction, ticagrelor reduces cardiovascular and sepsis-related mortality, and can cause dyspnea. It is suggested that this is caused by adenosine receptor stimulation, because in preclinical studies, ticagrelor blocks the nucleoside transporter and increases cellular ATP release. We now investigated the effects of ticagrelor on the adenosine system in humans in vivo.In a double-blinded, placebo-controlled cross-over trial in 14 healthy subjects, we have tested whether ticagrelor (180 mg affects adenosine- and dipyridamole-induced forearm vasodilation, as surrogates of nucleoside uptake inhibition and adenosine formation, respectively. Also, ex vivo uptake of adenosine and uridine in isolated red blood cells was measured. Primary endpoint was adenosine-induced vasodilation.Ticagrelor did not affect adenosine- or dipyridamole-induced forearm vasodilation. Also, ex vivo uptake of adenosine and uridine in isolated red blood cells was not affected by ticagrelor. In vitro, ticagrelor dose-dependently inhibited nucleoside uptake, but only at supra-physiological concentrations.In conclusion, at relevant plasma concentration, ticagrelor does not affect adenosine transport, nor adenosine formation in healthy subjects. Therefore, it is unlikely that this mechanism is a relevant pleiotropic effect of ticagrelor.ClinicalTrials.gov NCT01996735.

  19. Ticagrelor Does Not Inhibit Adenosine Transport at Relevant Concentrations: A Randomized Cross-Over Study in Healthy Subjects In Vivo

    Science.gov (United States)

    Rongen, G. A.; van den Broek, P. H. H.; Bilos, A.; Donders, A. R. T.; Gomes, M. E.; Riksen, N. P.

    2015-01-01

    Background and Purpose In patients with myocardial infarction, ticagrelor reduces cardiovascular and sepsis-related mortality, and can cause dyspnea. It is suggested that this is caused by adenosine receptor stimulation, because in preclinical studies, ticagrelor blocks the nucleoside transporter and increases cellular ATP release. We now investigated the effects of ticagrelor on the adenosine system in humans in vivo. Experimental Approach In a double-blinded, placebo-controlled cross-over trial in 14 healthy subjects, we have tested whether ticagrelor (180 mg) affects adenosine- and dipyridamole-induced forearm vasodilation, as surrogates of nucleoside uptake inhibition and adenosine formation, respectively. Also, ex vivo uptake of adenosine and uridine in isolated red blood cells was measured. Primary endpoint was adenosine-induced vasodilation. Key Results Ticagrelor did not affect adenosine- or dipyridamole-induced forearm vasodilation. Also, ex vivo uptake of adenosine and uridine in isolated red blood cells was not affected by ticagrelor. In vitro, ticagrelor dose-dependently inhibited nucleoside uptake, but only at supra-physiological concentrations. Conclusion and Implications In conclusion, at relevant plasma concentration, ticagrelor does not affect adenosine transport, nor adenosine formation in healthy subjects. Therefore, it is unlikely that this mechanism is a relevant pleiotropic effect of ticagrelor. Trial Registration ClinicalTrials.gov NCT01996735 PMID:26509673

  20. Impact of chromium dinicocysteinate supplementation on inflammation, oxidative stress, and insulin resistance in type 2 diabetic subjects: an exploratory analysis of a randomized, double-blind, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Zainulabedin M. Saiyed

    2016-09-01

    Full Text Available Background: Chromium dinicocysteinate (CDNC is a unique chromium complex consisting of chromium, niacin, and L-cysteine. Previous preclinical and clinical studies support the safety and efficacy of CDNC in modulating oxidative stress, vascular inflammation, and glycemia in type 2 diabetes. Objective: Herein, we report the results of several exploratory analyses conducted on type 2 diabetic subjects who previously participated in a 3-month randomized, double-blind, placebo-controlled trial and were treated with only metformin as standard diabetic care in addition to receiving the test supplementations. Design: Results from 43 metformin users, who were randomly assigned to receive either placebo (P, n=13, chromium picolinate (CP, 400 µg elemental Cr3+/day, n=12, or CDNC (400 µg elemental Cr3+/day, n=18, were analyzed for blood markers of vascular inflammation, insulin resistance, and oxidative stress at baseline and at 3 months of supplementation. Results: A statistically significant decrease in insulin resistance in the CDNC-supplemented cohort compared to placebo (p=0.01 was observed at 3 months. The CDNC group also demonstrated a significant reduction in insulin levels (p=0.03, protein carbonyl (p=0.02, and in TNF-α (p=0.03 compared to the placebo group. The CP group only showed a significant reduction in protein carbonyl levels (p=0.03 versus placebo. Conclusions: When controlling for diabetes medication, CDNC supplementation showed beneficial effects on blood markers of vascular inflammation, insulin resistance, and oxidative stress compared to placebo. The findings suggest that CDNC supplementation has potential as an adjunct therapy for individuals with type 2 diabetes.

  1. Effect of the cumin cyminum L. Intake on Weight Loss, Metabolic Profiles and Biomarkers of Oxidative Stress in Overweight Subjects: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    Taghizadeh, Mohsen; Memarzadeh, Mohammad Reza; Asemi, Zatollah; Esmaillzadeh, Ahmad

    2015-01-01

    The current study was performed to determine the effects of cumin cyminum L. intake on weight loss and metabolic profiles among overweight subjects. This randomized double-blind placebo-controlled clinical trial was conducted among 78 overweight subjects (male, n = 18; female, n = 60) aged 18-60 years old. Participants were randomly assigned into three groups to receive: (1) cumin cyminum L. capsule (n = 26); (2) orlistat120 capsule (n = 26) and (3) placebo (n = 26) three times a day for 8 weeks. Anthropometric measures and fasting blood samples were taken at baseline and after 8 weeks of intervention. Consumption of the Cuminum cyminum L. and orlistat120 resulted in a similar significant decrease in weight (-1.1 ± 1.2 and -0.9 ± 1.5 vs. 0.2 ± 1.5 kg, respectively, p = 0.002) and BMI (-0.4 ± 0.5 and -0.4 ± 0.6 vs. 0.1 ± 0.6 kg/m(2), respectively, p = 0.003) compared with placebo. In addition, taking Cuminum cyminum L., compared with orlistat and placebo, led to a significant reduction in serum insulin levels (-1.4 ± 4.5 vs. 1.3 ± 3.3 and 0.3 ± 2.2 µIU/ml, respectively, p = 0.02), HOMA-B (-5.4 ± 18.9 vs. 5.8 ± 13.3 and 1.0 ± 11.0, respectively, p = 0.02) and a significant rise in QUICKI (0.01 ± 0.01 vs. -0.005 ± 0.01 and -0.004 ± 0.01, respectively, p = 0.02). Taking cumin cyminum L. for eight weeks among overweight subjects had the same effects of orlistat120 on weight and BMI and beneficial effects on insulin metabolism compared with orlistat120 and placebo. © 2015 S. Karger AG, Basel.

  2. Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial.

    Science.gov (United States)

    Ruffini, Nuria; D'Alessandro, Giandomenico; Mariani, Nicolò; Pollastrelli, Alberto; Cardinali, Lucia; Cerritelli, Francesco

    2015-01-01

    Heart Rate Variability (HRV) indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS) function. To investigate the influence of osteopathic manipulative treatment (OMT) on cardiac autonomic modulation in healthy subjects, compared with sham therapy and control group. Sixty-six healthy subjects, both male and female, were included in the present 3-armed randomized placebo controlled within subject cross-over single blinded study. Participants were asymptomatic adults (26.7 ± 8.4 y, 51% male, BMI 18.5 ± 4.8), both smokers and non-smokers and not on medications. At enrollment subjects were randomized in three groups: A, B, C. Standardized structural evaluation followed by a patient need-based osteopathic treatment was performed in the first session of group A and in the second session of group B. Standardized evaluation followed by a protocoled sham treatment was provided in the second session of group A and in the first session of group B. No intervention was performed in the two sessions of group C, acting as a time-control. The trial was registered on clinicaltrials.gov identifier: NCT01908920. HRV was calculated from electrocardiography before, during and after the intervention, for a total amount time of 25 min and considering frequency domain as well as linear and non-linear methods as outcome measures. OMT engendered a statistically significant increase of parasympathetic activity, as shown by High Frequency power (p ANS activity increasing parasympathetic function and decreasing sympathetic activity, compared to sham therapy and control group.

  3. Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Nuria eRuffini

    2015-08-01

    Full Text Available Context: Heart Rate Variability (HRV indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS function. Objective: To investigate the influence of osteopathic manipulative treatment (OMT on ANS activity through changes of High Frequency, a heart rate variability index indicating the parasympathetic activity, in healthy subjects, compared with sham therapy and control group.Methods: Sixty-six healthy subjects, both male and female, were included in the present 3-armed randomized placebo controlled within subject cross-over single blinded study. Participants were asymptomatic adults, both smokers and non-smokers and not on medications. At enrollment subjects were randomized in 3 groups: A, B, C. Standardized structural evaluation followed by a patient need-based osteopathic treatment was performed in the first session of group A and in the second session of group B. Standardized evaluation followed by a protocoled sham treatment was provided in the second session of group A and in the first session of group B. No intervention was performed in the two sessions of group C, acting as a time-control. The trial was registered on clinicaltrials.gov identifier: NCT01908920.Main Outcomes Measures: HRV was calculated from electrocardiography before, during and after the intervention, for a total amount time of 25 minutes.Results: OMT engendered a statistically significant increase of parasympathetic activity, as shown by High Frequency rate (p<0.001, and decrease of sympathetic activity, as revealed by Low Frequency rate (p<0.01; results also showed a reduction of Low Frequency/High Frequency ratio (p<0.001 and Detrended fluctuation scaling exponent (p<0.05. Conclusions: Findings suggested that OMT can influence ANS activity increasing parasympathetic function and decreasing sympathetic activity, compared to sham therapy and control group.

  4. Modulation of protein fermentation does not affect fecal water toxicity: a randomized cross-over study in healthy subjects.

    Directory of Open Access Journals (Sweden)

    Karen Windey

    Full Text Available Protein fermentation results in production of metabolites such as ammonia, amines and indolic, phenolic and sulfur-containing compounds. In vitro studies suggest that these metabolites might be toxic. However, human and animal studies do not consistently support these findings. We modified protein fermentation in healthy subjects to assess the effects on colonic metabolism and parameters of gut health, and to identify metabolites associated with toxicity.After a 2-week run-in period with normal protein intake (NP, 20 healthy subjects followed an isocaloric high protein (HP and low protein (LP diet for 2 weeks in a cross-over design. Protein fermentation was estimated from urinary p-cresol excretion. Fecal metabolite profiles were analyzed using GC-MS and compared using cluster analysis. DGGE was used to analyze microbiota composition. Fecal water genotoxicity and cytotoxicity were determined using the Comet assay and the WST-1-assay, respectively, and were related to the metabolite profiles.Dietary protein intake was significantly higher during the HP diet compared to the NP and LP diet. Urinary p-cresol excretion correlated positively with protein intake. Fecal water cytotoxicity correlated negatively with protein fermentation, while fecal water genotoxicity was not correlated with protein fermentation. Heptanal, 3-methyl-2-butanone, dimethyl disulfide and 2-propenyl ester of acetic acid are associated with genotoxicity and indole, 1-octanol, heptanal, 2,4-dithiapentane, allyl-isothiocyanate, 1-methyl-4-(1-methylethenyl-benzene, propionic acid, octanoic acid, nonanoic acid and decanoic acid with cytotoxicity.This study does not support a role of protein fermentation in gut toxicity. The identified metabolites can provide new insight into colonic health.ClinicalTrial.gov NCT01280513.

  5. Interactive Assignments for Online Students

    Directory of Open Access Journals (Sweden)

    Pam Lowry

    2009-04-01

    Full Text Available Students can experience first hand through interactive assignments what is involved in teaching an online course. Most students develop a whole new appreciation for the student learning process. Faculty are beginning to realize that online instruction is more than a series of readings posted to a course management system. This paper summarizes the faculty member's instructional strategies involved when creating student interaction assignments. The paper also summarizes the assignments, discussion board, and trends in education from the student's perspective. In summary, it concludes with the faculty's overall perspective concerning these assignments and how the assignments could be more effective for the student.

  6. The effect of a high-fat breakfast on the pharmacokinetics of moxidectin in healthy male subjects: a randomized phase I trial.

    Science.gov (United States)

    Korth-Bradley, Joan M; Parks, Virginia; Chalon, Stephan; Gourley, Ian; Matschke, Kyle; Cailleux, Karine; Fitoussi, Serge; Fleckenstein, Lawrence

    2012-01-01

    The objective of this study was to assess the effect of a high-fat meal on the pharmacokinetics of moxidectin. Healthy male subjects were randomized to receive single oral 8 mg doses of moxidectin after an overnight fast or high-fat breakfast. In fasted subjects (N = 27), mean [SD] parameters were C(max): 58.9 [12.5] ng/mL; t(max): 3.7 [1.5] h; area under concentration-time curve (AUC): 3,387 [1,328] ng/h/mL; Vλ(z)/F: 2,829 [1,267] L; CL/F: 2.76 [1.28] L/h; and t(1/2): 784 [347] h. Compared with fasted subjects, fed subjects (N = 27) exhibited a 34% increase in C(max), delay in t(max) to 5.3 [2.1] h, 44% increase in AUC, 40% decrease in Vλ(z)/F, and a 35% decrease in CL/F. There was no significant change in t(1/2). The changes are consistent with an increase in moxidectin bioavailability following administration with food. There were no clinically relevant changes in vital signs, laboratory tests, or electrocardiograms.

  7. A Bayesian approach to simultaneously quantify assignments and linguistic uncertainty

    Energy Technology Data Exchange (ETDEWEB)

    Chavez, Gregory M [Los Alamos National Laboratory; Booker, Jane M [BOOKER SCIENTIFIC FREDERICKSBURG; Ross, Timothy J [UNM

    2010-10-07

    Subject matter expert assessments can include both assignment and linguistic uncertainty. This paper examines assessments containing linguistic uncertainty associated with a qualitative description of a specific state of interest and the assignment uncertainty associated with assigning a qualitative value to that state. A Bayesian approach is examined to simultaneously quantify both assignment and linguistic uncertainty in the posterior probability. The approach is applied to a simplified damage assessment model involving both assignment and linguistic uncertainty. The utility of the approach and the conditions under which the approach is feasible are examined and identified.

  8. Neuromodulation directed at the prefrontal cortex of subjects with obesity reduces snack food intake and hunger in a randomized trial.

    Science.gov (United States)

    Heinitz, Sascha; Reinhardt, Martin; Piaggi, Paolo; Weise, Christopher M; Diaz, Enrique; Stinson, Emma J; Venti, Colleen; Votruba, Susanne B; Wassermann, Eric M; Alonso-Alonso, Miguel; Krakoff, Jonathan; Gluck, Marci E

    2017-12-01

    Background: Obesity is associated with reduced activation in the left dorsolateral prefrontal cortex (DLPFC), a region of the brain that plays a key role in the support of self-regulatory aspects of eating behavior and inhibitory control. Transcranial direct current stimulation (tDCS) is a noninvasive technique used to modulate brain activity. Objectives: We tested whether repeated anodal tDCS targeted at the left DLPFC (compared with sham tDCS) has an immediate effect on eating behavior during ad libitum food intake, resulting in weight change, and whether it might influence longer-term food intake-related appetite ratings in individuals with obesity. Design: In a randomized parallel-design study combining inpatient and outpatient assessments over 31 d, 23 individuals with obesity [12 men; mean ± SD body mass index (BMI; in kg/m 2 ): 39.3 ± 8.42] received 15 sessions of anodal (i.e., enhancing cortical activity) or sham tDCS aimed at the left DLPFC. Ad libitum food intake was assessed through the use of a vending machine paradigm and snack food taste tests (SFTTs). Appetite was evaluated with a visual analog scale (VAS). Body weight was measured. We examined the effect of short-term (i.e., 3 sessions) and long-term (i.e., 15 sessions) tDCS on these variables. Results: Relative to sham tDCS, short-term anodal tDCS did not influence ad libitum intake of food from the vending machines. Accordingly, no effect on short-term or 4-wk weight change was observed. In the anodal tDCS group, compared with the sham group, VAS ratings for hunger and the urge to eat declined significantly more ( P = 0.01 and P = 0.05, respectively), and total energy intake during an SFTT was relatively lower in satiated individuals ( P = 0.01), after long-term tDCS. Conclusions: Short-term anodal tDCS of the left DLPFC did not have an immediate effect on ad libitum food intake or thereby weight change, relative to sham tDCS. Hunger and snack food intake were reduced only after a longer period

  9. Efficacy and safety of two new formulations of artificial tears in subjects with dry eye disease: a 3-month, multicenter, active-controlled, randomized trial

    Directory of Open Access Journals (Sweden)

    Simmons PA

    2015-04-01

    Full Text Available Peter A Simmons, Haixia Liu, Cindy Carlisle-Wilcox, Joseph G Vehige Allergan Clinical Research, Allergan, Inc., Irvine, CA, USA Purpose: To evaluate and compare the efficacy and safety of two investigational artificial tear formulations (CHO-1 and CHO-2 containing carmellose sodium, hyaluronic acid at different concentrations, and osmoprotectants, with a standard carmellose sodium-containing formulation (Refresh Tears [RT] in the treatment of dry eye disease. Subjects and methods: In this 3-month, double-masked, multicenter study, subjects (n=305 were randomized 1:1:1 to receive CHO-1, CHO-2, or RT, used as needed but at least twice daily. The primary endpoint was change in ocular surface disease index (OSDI score from baseline to day 90. Other key outcomes included symptoms evaluated on a visual analog scale, corneal and conjunctival staining, and adverse events. Results: OSDI scores and dry eye symptoms showed a rapid and sustained reduction from baseline in each group. Both CHO-1 and CHO-2 met the primary efficacy endpoint of noninferiority to RT in day 90 OSDI score change from baseline. OSDI ocular symptoms subscale improved more with CHO-1 than CHO-2 (P=0.048. In subjects with clinically relevant baseline ocular surface staining (>14 total score of a maximum of 55, day 90 improvements were greater with CHO-1 and CHO-2 than RT (P≤0.044. Day 90 improvements in OSDI ocular symptoms subscale scores were also greater with CHO-1 than RT (P<0.007 in subjects with clinically relevant ocular staining. All treatments were well tolerated.Conclusion: Both combination artificial tear formulations were efficacious and well tolerated in subjects with dry eye. CHO-1 demonstrated the best performance in improving ocular symptoms and reducing ocular staining in this heterogeneous study population. Keywords: dry eye syndromes, ophthalmic solutions, carmellose, hyaluronic acid

  10. Effects of Food on the Pharmacokinetics of Omega-3-Carboxylic Acids in Healthy Japanese Male Subjects: A Phase I, Randomized, Open-label, Three-period, Crossover Trial.

    Science.gov (United States)

    Shimada, Hitoshi; Nilsson, Catarina; Noda, Yoshinori; Kim, Hyosung; Lundström, Torbjörn; Yajima, Toshitaka

    2017-09-01

    Omega-3-carboxylic acids (OM3-CA) contain omega-3 free fatty acids, such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), as carboxylic acids. Food intake is known to affect the bioavailability of ethyl ester fatty acid formulations. We conducted a phase I study to investigate the effects of the timing of OM3-CA administration relative to food intake on the pharmacokinetics of EPA and DHA. In this randomized, open-label, three-period crossover study, Japanese healthy male subjects were administered 4×1 g OM3-CA capsules with continued fasting, before a meal, or after a meal. All subjects fasted for ≥10 h prior to drug/meal administration. The primary objective was to examine the effect of meal timing on the pharmacokinetics of EPA and DHA after OM3-CA administration. The secondary objectives were to examine the safety and tolerability of OM3-CA. A total of 42 Japanese subjects was enrolled in the study. The baseline-adjusted maximum concentration and area under the concentration-time curve from 0 to 72 h for EPA, DHA, and EPA +DHA were lower in the fasting and before meal conditions than in the after meal condition. The maximum total EPA, total DHA, and total EPA+DHA concentrations were reached later when administered in fasting conditions than in fed conditions, indicating slower absorption in fasting conditions. Diarrhea was reported by five, six, and no subjects in the fasting, before meal, and after meal conditions, respectively. The timing of OM3-CA administration relative to food intake influences the systemic bioavailability of EPA and DHA in healthy Japanese male subjects. NCT02372344.

  11. The effect of dry needling on the radiating pain in subjects with discogenic low-back pain: A randomized control trial.

    Science.gov (United States)

    Mahmoudzadeh, Ashraf; Rezaeian, Zahra Sadat; Karimi, Abdolkarim; Dommerholt, Jan

    2016-01-01

    Disk herniation is the most common cause of radiating low back pain (LBP) in subjects under 60 years of age. The present study aims to compare the effect of dry needling (DN) and a standard conservative approach on the pain and function in subjects with discogenic radiating LBP. Fifty-eight subjects with discogenic radicular LBP were screened and randomized into control (Standard physical therapy, n = 29) and experimental group (Standard physical therapy and DN, n = 29). Radiating pain intensity and disability were measured using visual analog scale (VAS) and Oswestry Disability indices at baseline, at the end of treatment and 2 months after the last intervention session. The changes in pain intensity and disability were studied using a 3 × 2 repeated measures analysis of variance considering time as the within-subject factor and group as the between-subject. Pain intensity and disability scores decreased significantly in both experimental and control groups (experimental group: VAS = 37.24, Oswestry Disability Index [ODI] =28.48, control group: VAS = 45.5, ODI = 32.96), following the intervention. The change continued during the follow-up period (P < 0.001 for all comparisons). Pain and disability improvement, however, were more significant in experimental group, both in post intervention (experimental group: VAS = 25.17, ODI = 22.17, control group: VAS = 42.4, ODI = 30.27) (P = 0.05 and P = 0.03, respectively) and follow-up measures (P = 0.006 and P = 0.002, respectively). Both intervention strategies seem to significantly improve pain and disability immediately following intervention, where the improvement continued during 2 months after the last active intervention. Therefore, supplementary DN application may enhance the effect of the standard intervention considerably.

  12. The effect of dry needling on the radiating pain in subjects with discogenic low-back pain: A randomized control trial

    Directory of Open Access Journals (Sweden)

    Ashraf Mahmoudzadeh

    2016-01-01

    Full Text Available Background: Disk herniation is the most common cause of radiating low back pain (LBP in subjects under 60 years of age. The present study aims to compare the effect of dry needling (DN and a standard conservative approach on the pain and function in subjects with discogenic radiating LBP. Materials and Methods: Fifty-eight subjects with discogenic radicular LBP were screened and randomized into control (Standard physical therapy, n = 29 and experimental group (Standard physical therapy and DN, n = 29. Radiating pain intensity and disability were measured using visual analog scale (VAS and Oswestry Disability indices at baseline, at the end of treatment and 2 months after the last intervention session. The changes in pain intensity and disability were studied using a 3 × 2 repeated measures analysis of variance considering time as the within-subject factor and group as the between-subject. Results: Pain intensity and disability scores decreased significantly in both experimental and control groups (experimental group: VAS = 37.24, Oswestry Disability Index [ODI] =28.48, control group: VAS = 45.5, ODI = 32.96, following the intervention. The change continued during the follow-up period (P < 0.001 for all comparisons. Pain and disability improvement, however, were more significant in experimental group, both in post intervention (experimental group: VAS = 25.17, ODI = 22.17, control group: VAS = 42.4, ODI = 30.27 (P = 0.05 and P = 0.03, respectively and follow-up measures (P = 0.006 and P = 0.002, respectively. Conclusion: Both intervention strategies seem to significantly improve pain and disability immediately following intervention, where the improvement continued during 2 months after the last active intervention. Therefore, supplementary DN application may enhance the effect of the standard intervention considerably.

  13. Efficacy of multiwavelength light therapy in the treatment of pressure ulcers in subjects with disorders of the spinal cord: A randomized double-blind controlled trial.

    Science.gov (United States)

    Taly, Arun B; Sivaraman Nair, Krishan P; Murali, Thyloth; John, Archana

    2004-10-01

    To study the efficacy of multiwavelength light therapy in the treatment of pressure ulcers in subjects with spinal cord disorders. Randomized controlled trial. Neurologic rehabilitation ward of a referral center in India. Thirty-five subjects with spinal cord injury, with 64 pressure ulcers (stage 2, n=55; stage 3, n=8; stage 4, n=1), were randomized into treatment and control groups. One subject refused consent. Mean duration of ulcers in the treatment group was 34.2+/-45.5 days and in the control group, 57.1+/-43.5 days. Treatment group received 14 sessions of multiwavelength light therapy, with 46 probes of different wavelengths from a gallium-aluminum-arsenide laser source, 3 times a week. Energy used was 4.5 J/cm(2). Ulcers in the control group received sham treatment. Healing of the ulcer, defined as the complete closure of the wound with healthy scar tissue, time taken for the ulcer to heal, and stage of the ulcer and Pressure Sore Status Tool score 14 days after last treatment. There was no significant difference in healing between the treatment and control groups. Eighteen ulcers in treatment group and 14 in control group healed completely ( P =.802). Mean time taken by the ulcers to heal was 2.45+/-2.06 weeks in the treatment group and 1.78+/-2.13 weeks in the control group ( P =.330). Time taken for stage 3 and 4 ulcers to reach stage 2 was 2.25+/-0.5 weeks in treatment group and 4.33+/-1.53 weeks in control group ( P =.047). Multiwavelength light therapy from a gallium-aluminum-arsenide laser source did not influence overall healing pressure ulcers. Limited evidence suggested that it improved healing of stage 3 and 4 pressure ulcers.

  14. Black tea consumption improves postprandial glycemic control in normal and pre-diabetic subjects: a randomized, double-blind, placebo-controlled crossover study.

    Science.gov (United States)

    Butacnum, Arisa; Chongsuwat, Rewadee; Bumrungpert, Akkarach

    2017-01-01

    Postprandial glycemic control is important for prevention of diabetes. Black tea consumption may improve postprandial glycemic control. The major bioactive compounds are polyphenols, black tea polymerized polyphenol (BTPP).This study examined the effect of black tea consumption on postprandial blood glucose and insulin response following sucrose loading in normal and pre-diabetes subjects. This study was a randomized, double-blind, placebo-controlled crossover study. Twenty-four subjects, male and female aged 20-60 years, normal and pre-diabetic, randomly ingested a sucrose solution with a low dose (110 mg BTPP), a high dose (220 mg BTPP) of black tea drink or a placebo drink (0 mg BTPP). Blood samples were collected at 0, 30, 60, 90, and 120 min from commencement of drink ingestion to measure blood glucose and insulin levels. The drink containing low dose and high dose BTPP significantly decreased incremental blood glucose area under the curve (AUC) after sucrose intake compared with placebo in the normal (T0-60 min 3,232±356 vs 3,295±312 vs 3,652±454 mg.min/dL; p=0.016) and pre-diabetic subjects (T0-60 min 2,554±395 vs 2,472±280 vs 2,888±502 mg.min/dL; p=0.048). There was no statistically significant difference of changes in insulin levels between the placebo and black tea groups (p>0.05). No significant differences in adverse effects were observed with the placebo, low dose and high dose of BTPP groups. Black tea consumption can decrease postprandial blood glucose after sucrose intake.

  15. Evaluation of Clinical Effectiveness and Subjective Satisfaction of a New Toothbrush for Postsurgical Hygiene Care: A Randomized Split-Mouth Double-Blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    Marco Montevecchi

    2015-01-01

    Full Text Available The aim of this RCT was to evaluate plaque control and gingival health promotion effectiveness of a new toothbrush with extra-soft filaments in postsurgical sets. Ten consecutive patients with at least two scheduled symmetrical periodontal surgeries were selected. Following the first periodontal surgery, a test (TB1 or control (TB2 toothbrush was randomly assigned. After the second surgery, the remaining toothbrush was given. Patients were asked to gently wipe the surgical area from days 3 to 7 postoperatively and to gently brush using a roll technique from day 7 till the end of the study. Baseline evaluation took place on the day of surgery and follow-ups were performed at days 7, 14, and 30 postoperatively. A more evident PI reduction was recorded for test toothbrush where a regular decrease was observed till day 14; then, this parameter tended to stabilize, remaining however lower than that recorded for the control toothbrush. There were no statistical differences in the GI between test and control toothbrushes. All patients introduced the test toothbrush at surgical site at third day; the control toothbrush was introduced within a mean of 9 days. The introduction of the test toothbrush 3 days after periodontal surgery may be recommended.

  16. Effect of weight-loss program using self-weighing twice a day and feedback in overweight and obese subject: a randomized controlled trial.

    Science.gov (United States)

    Oshima, Yoshitake; Matsuoka, Yukiyo; Sakane, Naoki

    2013-01-01

    To investigate the effectiveness of self-weighing twice a day with a supportive program installed on a body composition monitor in overweight adults. Sixty adults with BMI > 24 kg/m(2) were randomly assigned to either a group that weighed themselves once per day (group 1, n = 30) or a group that weighed themselves twice per day (group 2, n = 30). Group 1 was instructed to self-weigh at the same time once per day and group 2 was instructed to self-weigh immediately after waking up in the morning and immediately before going to bed every day for twelve weeks. In addition, participants in group 2 was received the daily target setting during morning weighing and the difference between the measured weight and the target weight during bedtime weighing. Average weight reduction in group 1 was significantly lower than that in group 2 (1.0 ± 1.4 kg vs. 2.7 ± 2.1 kg, p weight in group 2 was significantly higher than that in group 1 (28.6% vs. 3.6%, p weight loss than once-daily self-measurement. © 2013 Asian Oceanian Association for the Study of Obesity. Published by Elsevier Ltd. All rights reserved.

  17. Acetyl-coenzyme A carboxylase inhibition reduces de novo lipogenesis in overweight male subjects: A randomized, double-blind, crossover study.

    Science.gov (United States)

    Stiede, Kathryn; Miao, Wenyan; Blanchette, Heather S; Beysen, Carine; Harriman, Geraldine; Harwood, H James; Kelley, Heather; Kapeller, Rosana; Schmalbach, Tess; Westlin, William F

    2017-08-01

    NDI-010976, an allosteric inhibitor of acetyl-coenzyme A carboxylases (ACC) ACC1 and ACC2, reduces hepatic de novo lipogenesis (DNL) and favorably affects steatosis, inflammation, and fibrosis in animal models of fatty liver disease. This study was a randomized, double-blind, placebo-controlled, crossover trial evaluating the pharmacodynamic effects of a single oral dose of NDI-010976 on hepatic DNL in overweight and/or obese but otherwise healthy adult male subjects. Subjects were randomized to receive either NDI-010976 (20, 50, or 200 mg) or matching placebo in period 1, followed by the alternate treatment in period 2; and hepatic lipogenesis was stimulated with oral fructose administration. Fractional DNL was quantified by infusing a stable isotope tracer, [1-13 C]acetate, and monitoring 13 C incorporation into palmitate of circulating very low-density lipoprotein triglyceride. Single-dose administration of NDI-010976 was well tolerated at doses up to and including 200 mg. Fructose administration over a 10-hour period stimulated hepatic fractional DNL an average of 30.9 ± 6.7% (mean ± standard deviation) above fasting DNL values in placebo-treated subjects. Subjects administered single doses of NDI-010976 at 20, 50, or 200 mg had significant inhibition of DNL compared to placebo (mean inhibition relative to placebo was 70%, 85%, and 104%, respectively). An inverse relationship between fractional DNL and NDI-010976 exposure was observed with >90% inhibition of fractional DNL associated with plasma concentrations of NDI-010976 >4 ng/mL. ACC inhibition with a single dose of NDI-010976 is well tolerated and results in a profound dose-dependent inhibition of hepatic DNL in overweight adult male subjects. Therefore, NDI-010976 could contribute considerable value to the treatment algorithm of metabolic disorders characterized by dysregulated fatty acid metabolism, including nonalcoholic steatohepatitis. (Hepatology 2017;66:324-334). © 2017 Nimbus Discovery, Inc

  18. Efficacy and tolerability of Meratrim for weight management: a randomized, double-blind, placebo-controlled study in healthy overweight human subjects.

    Science.gov (United States)

    Kudiganti, Venkateshwarlu; Kodur, Raveendra Ramamurthy; Kodur, Sushma Raveendra; Halemane, Manjunath; Deep, Dheeraj Kumar

    2016-08-24

    Meratrim is a blend of two plant extracts obtained from Sphaeranthus indicus flower heads and Garcinia mangostana fruit rinds. Previous studies have demonstrated that Meratrim is effective for weight management in obese individuals. The objective of this study was to assess the efficacy and tolerability of Meratrim in managing body weight in healthy overweight subjects. Sixty participants with a mean BMI of 28.3 kg/m(2) were randomized into two groups receiving either 400 mg of Meratrim twice daily or two identical placebo capsules for a period of 16 weeks. Subjects were asked to consume about 2,000 kcal/day throughout the study period and walk 5 days a week for 30 min daily. The primary endpoint was defined as the change in body weight from baseline to end of week 16 for the Meratrim group versus placebo. Fifty seven subjects completed the trial. At study conclusion, statistically significant reductions in body weight (5.09 vs. 1.1 kg; p 38 vs. 5.11 cm; p nic.in.

  19. Evaluation of the effect of food and age on the pharmacokinetics of oral netupitant and palonosetron in healthy subjects: A randomized, open-label, crossover phase 1 study.

    Science.gov (United States)

    Calcagnile, Selma; Lanzarotti, Corinna; Gutacker, Michaela; Jakob-Rodamer, Verena; Peter Kammerer, Klaus; Timmer, Wolfgang

    2015-09-01

    Antiemetic treatment compliance is important to prevent chemotherapy-induced nausea and vomiting, a feared chemotherapy side effect. NEPA, a new oral fixed combination of netupitant, a highly selective NK1 receptor antagonist (RA), and palonosetron, a second-generation 5-HT3 RA, targets dual antiemetic pathways with a single dose. This study investigated the effect of food intake and age on NEPA pharmacokinetics (PK) and safety. In this open-label, single-center, randomized, phase 1 study, 24 adults (18-45 years) received NEPA in a fed or fasted state during the first treatment period and in the alternative state in the next treatment period. Twelve elderly subjects (≥65 years) received NEPA in a fasted state. Blood samples were taken for netupitant and palonosetron PK analysis. In the fed condition, netupitant plasma exposure increased, whereas palonosetron PK parameters were not affected. Furthermore, elderly subjects showed increased netupitant and palonosetron exposure compared with adults. All adverse events were mild/moderate, with constipation and headache the most common. Although food intake and age altered NEPA PK, dose adjustments were not needed, as netupitant and palonosetron exposure increases did not lead to safety concerns in healthy subjects. © 2015, The American College of Clinical Pharmacology.

  20. Effects of 8-Week Hatha Yoga Training on Metabolic and Inflammatory Markers in Healthy, Female Chinese Subjects: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Neng Chen

    2016-01-01

    Full Text Available We aimed to determine the effects of an 8 wk Hatha yoga training on blood glucose, insulin, lipid profiles, endothelial microparticles (EMPs, and inflammatory status in healthy, lean, and female Chinese subjects. A total of 30 healthy, female Chinese subjects were recruited and randomized into control or yoga practice group. The yoga practice included 8 wks of yoga practice (2 times/wk for a total of 16 times. Fasting blood samples were collected before and after yoga training. Plasma was isolated for the measurement of lipid profiles, glucose, insulin, EMPs, and inflammatory cytokines. Whole blood was cultured ex vivo and stimulated with lipopolysaccharide (LPS and Pam3Cys-SK4. Peripheral blood mononuclear cells (PBMCs were isolated for the measurement of TLR2 and TLR4 protein expression. Yoga practice significantly reduced plasma cholesterol, LDL-cholesterol, insulin levels, and CD31+/CD42b− EMPs. Cultured whole blood from the yoga group has reduced proinflammatory cytokines secretion both at unstimulated condition and when stimulated with Pam3Cys-SK4; this might be associated with reduced TLR2 protein expression in PBMCs after yoga training. Hatha yoga practice in healthy Chinese female subjects could improve hallmarks related to MetS; thus it can be considered as an ancillary intervention in the primary MetS prevention for the healthy population. This trial is registered with ChiCTR-IOR-14005747.

  1. The pursuit of balance: An overview of covariate-adaptive randomization techniques in clinical trials.

    Science.gov (United States)

    Lin, Yunzhi; Zhu, Ming; Su, Zheng

    2015-11-01

    Randomization is fundamental to the design and conduct of clinical trials. Simple randomization ensures independence among subject treatment assignments and prevents potential selection biases, yet it does not guarantee balance in covariate distributions across treatment groups. Ensuring balance in important prognostic covariates across treatment groups is desirable for many reasons. A broad class of randomization methods for achieving balance are reviewed in this paper; these include block randomization, stratified randomization, minimization, and dynamic hierarchical randomization. Practical considerations arising from experience with using the techniques are described. A review of randomization methods used in practice in recent randomized clinical trials is also provided. Copyright © 2015 Elsevier Inc. All rights reserved.

  2. The bicriterion multimodal assignment problem

    DEFF Research Database (Denmark)

    Pedersen, Christian Roed; Nielsen, Lars Relund; Andersen, Kim Allan

    2008-01-01

    We consider the bicriterion multimodal assignment problem, which is a new generalization of the classical linear assignment problem. A two-phase solution method using an effective ranking scheme is presented. The algorithm is valid for generating all nondominated criterion points or an approximat......We consider the bicriterion multimodal assignment problem, which is a new generalization of the classical linear assignment problem. A two-phase solution method using an effective ranking scheme is presented. The algorithm is valid for generating all nondominated criterion points...

  3. Ant Colony Algorithm and Simulation for Robust Airport Gate Assignment

    Directory of Open Access Journals (Sweden)

    Hui Zhao

    2014-01-01

    Full Text Available Airport gate assignment is core task for airport ground operations. Due to the fact that the departure and arrival time of flights may be influenced by many random factors, the airport gate assignment scheme may encounter gate conflict and many other problems. This paper aims at finding a robust solution for airport gate assignment problem. A mixed integer model is proposed to formulate the problem, and colony algorithm is designed to solve this model. Simulation result shows that, in consideration of robustness, the ability of antidisturbance for airport gate assignment scheme has much improved.

  4. Controlling on-demand gastric acidity in obese subjects: a randomized, controlled trial comparing a single dose of 20 mg rabeprazole and 20 mg omeprazole.

    Science.gov (United States)

    Belhocine, Kafia; Vavasseur, Fabienne; Volteau, Christelle; Flet, Laurent; Touchefeu, Yann; Bruley des Varannes, Stanislas

    2014-07-15

    Obesity is associated with a risk of gastroesophageal reflux disease. The pharmacodynamic efficacy of proton pump inhibitors has not been specifically evaluated in obese subjects. The aim of this study was to compare the antisecretory response to a single oral dose of 20 mg rabeprazole, 20 mg omeprazole and placebo in obese subjects. Gastric pH was monitored for 24 hours on three separate occasions in eighteen H. pylori-negative, asymptomatic obese subjects. Subjects were given omeprazole, rabeprazole or placebo in a randomized order and in a double-blind fashion. The main analysis criterion was 24-h percent of time post dose with intragastric pH above 3; secondary criteria were percentage of time above pH 4, median pH, [H+] concentrations and nocturnal acid breakthrough (NAB). Results were analyzed using linear mixed models and Wilks test comparing variances. 24-h median [IQ] percentages of time with gastric pH above 3 and 4 were higher with rabeprazole than omeprazole (46 [37-55] vs. 30 [15-55] %, 9 [5-11] % for placebo) but the differences did not reach statistical significance (p = 0.11 and 0.24, respectively). Median acid concentrations were significantly lower with rabeprazole than with omeprazole and placebo (22 [14-53] vs. 54 [19-130] and 95 [73-170] mmoles/l, p omeprazole (median 1 [1,2] vs. 2 [1-3], p = 0.04). Variances of 24-h data (pH above 3 and 4, median pH, [H+] concentrations) were significantly lower with rabeprazole than with omeprazole (p omeprazole was strong and not significantly different between drugs despite a significantly more homogeneous response with rabeprazole. ClinicalTrial.gov: NCT01136317.

  5. The effects of morphine-neostigmine and secretin provocation on pancreaticobiliary morphology in healthy subjects: a randomized, double-blind crossover study using serial MRCP.

    Science.gov (United States)

    Chowdhury, Abeed H; Humes, David J; Pritchard, Susan E; Marciani, Luca; Gowland, Penny A; Simpson, John; Lobo, Dileep N

    2011-09-01

    Secretin-stimulated magnetic resonance cholangiopancreatography (MRCP) is used for the diagnosis of sphincter of Oddi dysfunction (SOD), but it does not correlate well with sphincter of Oddi manometry. Serial MRCP following morphine-neostigmine provocation may be of value in the assessment of SOD, but the effects of these pharmacological agents on pancreaticobiliary morphology in healthy subjects have not been studied. The aim of the present study was to use serial MRCP to characterize the effects of morphine-neostigmine and secretin provocation on serum pancreatic enzyme responses and pancreaticobiliary ductal morphology in healthy subjects. Following a baseline scan and serum lipase and amylase assays, 10 healthy subjects were randomized in a double-blind manner to receive morphine (10 mg intramuscularly [IM]), neostigmine (1 mg IM) and saline (intravenously [IV]); OR saline (IM), saline (IM) and secretin (1 U/kg IV). A MRCP study was performed at 5, 30, 60, 90, 120, 150, and 180 min thereafter, with blood samples taken every 60 min for 4 h. Pancreatic duct (PD) diameter, visible PD length, common bile duct (CBD) diameter, and gallbladder volume were recorded. Crossover studies were performed 10 days later. Serum pancreatic enzyme concentrations were significantly greater (amylase, P = 0.003; lipase, P = 0.04) after morphine-neostigmine than after secretin. Following morphine-neostigmine and secretin provocation, the mean (SEM) percentage increase in PD diameter was 28.7 (7.2) versus 12.9 (3.3); P < 0.0001, and visible PD length was 49.4 (11.5) versus 28.1 (8.2); P < 0.0001, respectively. The effects of morphine-neostigmine were more pronounced than those of secretin in healthy subjects. The diagnostic utility of morphine-neostigmine stimulated serial MRCP for SOD merits further evaluation.

  6. Multi-Center Randomized Phase II Study Comparing Cediranib plus Gefitinib with Cediranib plus Placebo in Subjects with Recurrent/Progressive Glioblastoma.

    Directory of Open Access Journals (Sweden)

    Nicholas Brown

    Full Text Available Cediranib, an oral pan-vascular endothelial growth factor (VEGF receptor tyrosine kinase inhibitor, failed to show benefit over lomustine in relapsed glioblastoma. One resistance mechanism for cediranib is up-regulation of epidermal growth factor receptor (EGFR. This study aimed to determine if dual therapy with cediranib and the oral EGFR inhibitor gefitinib improved outcome in recurrent glioblastoma.This was a multi-center randomized, two-armed, double-blinded phase II study comparing cediranib plus gefitinib versus cediranib plus placebo in subjects with first relapse/first progression of glioblastoma following surgery and chemoradiotherapy. The primary outcome measure was progression free survival (PFS. Secondary outcome measures included overall survival (OS and radiologic response rate. Recruitment was terminated early following suspension of the cediranib program. 38 subjects (112 planned were enrolled with 19 subjects in each treatment arm. Median PFS with cediranib plus gefitinib was 3.6 months compared to 2.8 months for cediranib plus placebo (HR; 0.72, 90% CI; 0.41 to 1.26. Median OS was 7.2 months with cediranib plus gefitinib and 5.5 months with cediranib plus placebo (HR; 0.68, 90% CI; 0.39 to 1.19. Eight subjects (42% had a partial response in the cediranib plus gefitinib arm versus five patients (26% in the cediranib plus placebo arm.Cediranib and gefitinib in combination is tolerated in patients with glioblastoma. Incomplete recruitment led to the study being underpowered. However, a trend towards improved survival and response rates with the addition of gefitinib to cediranib was observed. Further studies of the combination incorporating EGFR and VEGF inhibition are warranted.ClinicalTrials.gov NCT01310855.

  7. Reversal of apixaban anticoagulation by four-factor prothrombin complex concentrates in healthy subjects: a randomized three-period crossover study.

    Science.gov (United States)

    Song, Y; Wang, Z; Perlstein, I; Wang, J; LaCreta, F; Frost, R J A; Frost, C

    2017-11-01

    Essentials Prothrombin complex concentrates (PCCs) may reverse the effect of factor Xa (FXa) inhibitors. We conducted an open-label, randomized, placebo-controlled, three-period crossover study in 15 subjects. Both PCCs rapidly reversed apixaban-mediated decreases in mean endogenous thrombin potential. Four-factor PCC administration had no effect on apixaban pharmacokinetics or anti-FXa activity. Background Currently, there is no approved reversal agent for direct activated factor Xa (FXa) inhibitors; however, several agents are under investigation, including prothrombin complex concentrates (PCCs). Objective This open-label, randomized, placebo-controlled, three-period crossover study assessed the effect of two four-factor PCCs on apixaban pharmacodynamics and pharmacokinetics in 15 healthy subjects. Methods Subjects received apixaban 10 mg twice daily for 3 days. On day 4, 3 h after apixaban, subjects received a 30-min infusion of 50 IU kg-1 Cofact, Beriplex P/N (Beriplex), or saline. Change in endogenous thrombin potential (ETP), measured with a thrombin generation assay (TGA), was the primary endpoint. Secondary endpoints included changes in other TGA parameters, prothrombin time (PT), International Normalized Ratio (INR), activated partial thromboplastin time, anti-FXa activity, apixaban pharmacokinetics, and safety. Results Apixaban-related changes in ETP and several other pharmacodynamic measures occurred following apixaban administration. Both PCCs reversed apixaban's effect on ETP; the differences in adjusted mean change from pre-PCC baseline to end of infusion were 425 nm min (95% confidence interval [CI] 219.8-630.7 nm min; P 0.05) for Beriplex. Both PCCs returned ETP to pre-apixaban baseline levels 4 h after PCC infusion, versus 45 h for placebo. For both PCCs, mean ETP peaked 21 h after PCC initiation, and then slowly decreased over the following 48 h. Both PCCs reversed apixaban's effect on TGA peak height, PT, and INR. Apixaban pharmacokinetic and

  8. Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial

    Science.gov (United States)

    Ruffini, Nuria; D'Alessandro, Giandomenico; Mariani, Nicolò; Pollastrelli, Alberto; Cardinali, Lucia; Cerritelli, Francesco

    2015-01-01

    Context: Heart Rate Variability (HRV) indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS) function. Objective: To investigate the influence of osteopathic manipulative treatment (OMT) on cardiac autonomic modulation in healthy subjects, compared with sham therapy and control group. Methods: Sixty-six healthy subjects, both male and female, were included in the present 3-armed randomized placebo controlled within subject cross-over single blinded study. Participants were asymptomatic adults (26.7 ± 8.4 y, 51% male, BMI 18.5 ± 4.8), both smokers and non-smokers and not on medications. At enrollment subjects were randomized in three groups: A, B, C. Standardized structural evaluation followed by a patient need-based osteopathic treatment was performed in the first session of group A and in the second session of group B. Standardized evaluation followed by a protocoled sham treatment was provided in the second session of group A and in the first session of group B. No intervention was performed in the two sessions of group C, acting as a time-control. The trial was registered on clinicaltrials.gov identifier: NCT01908920. Main Outcomes Measures: HRV was calculated from electrocardiography before, during and after the intervention, for a total amount time of 25 min and considering frequency domain as well as linear and non-linear methods as outcome measures. Results: OMT engendered a statistically significant increase of parasympathetic activity, as shown by High Frequency power (p < 0.001), expressed in normalized and absolute unit, and possibly decrease of sympathetic activity, as revealed by Low Frequency power (p < 0.01); results also showed a reduction of Low Frequency/High Frequency ratio (p < 0.001) and Detrended fluctuation scaling exponent (p < 0.05). Conclusions: Findings suggested that OMT can influence ANS activity increasing

  9. Evaluation of Automatically Assigned Job-Specific Interview Modules

    NARCIS (Netherlands)

    Friesen, Melissa C; Lan, Qing; Ge, Calvin; Locke, Sarah J; Hosgood, Dean; Fritschi, Lin; Sadkowsky, Troy; Chen, Yu-Cheng; Wei, Hu; Xu, Jun; Lam, Tai Hing; Kwong, Yok Lam; Chen, Kexin; Xu, Caigang; Su, Yu-Chieh; Chiu, Brian C H; Ip, Kai Ming Dennis; Purdue, Mark P; Bassig, Bryan A; Rothman, Nat; Vermeulen, Roel

    OBJECTIVE: In community-based epidemiological studies, job- and industry-specific 'modules' are often used to systematically obtain details about the subject's work tasks. The module assignment is often made by the interviewer, who may have insufficient occupational hygiene knowledge to assign the

  10. Negotiating Languages and Cultures: Enacting Translingualism through a Translation Assignment

    Science.gov (United States)

    Kiernan, Julia; Meier, Joyce; Wang, Xiqiao

    2016-01-01

    This collaborative project explores the affordances of a translation assignment in the context of a learner-centered pedagogy that places composition students' movement among languages and cultures as both a site for inquiry and subject of analysis. The translation assignment asks students to translate scholarly articles or culture stories from…

  11. Effect of interferential current therapy on pain perception and disability level in subjects with chronic low back pain: a randomized controlled trial.

    Science.gov (United States)

    Albornoz-Cabello, Manuel; Maya-Martín, Julián; Domínguez-Maldonado, Gabriel; Espejo-Antúnez, Luis; Heredia-Rizo, Alberto Marcos

    2017-02-01

    To assess the short-term efficacy of transregional interferential current therapy on pain perception and disability level in chronic non-specific low back pain. A randomized, single-blinded (the assessor collecting the outcome data was blinded), controlled trial. A private physiotherapy research clinic. A total of 64 individuals, 20 men and 44 women, mean (SD) age was 51 years (11.93), with low back pain of more than three months, with or without pain radiating to the lower extremities above the knee, were distributed into a control ( n = 20) or an experimental group ( n = 44). A 2:1 randomization ratio was used in favour of the latter. A transregional interferential current electrotherapy protocol was performed for participants in the experimental group, while the control group underwent a 'usual care' treatment (massage, mobilization and soft-tissue techniques). All subjects received up to 10 treatment sessions of 25 minutes over a two-week period, and completed the intervention and follow-up evaluations. Self-perceived pain was assessed with a Visual Analogue Scale. Secondary measure included the Oswestry Low Back Disability Index. Evaluations were collected at baseline and after the intervention protocol. Significant between-group differences were found for interferential current therapy on pain perception ( p = 0.032) and disability level ( p = 0.002). The observed differences in the between-group mean changes were of 11.34 mm (1.77/20.91) and 13.38 points (4.97/21.78), respectively. A two-week transregional interferential current treatment has shown significant short-term efficacy, when compared with a 'usual care' protocol, on self-perceived pain and functionality in subjects with chronic low back pain.

  12. Short-term effect of spinal manipulation on pain perception, spinal mobility, and full height recovery in male subjects with degenerative disk disease: a randomized controlled trial.

    Science.gov (United States)

    Vieira-Pellenz, Felipe; Oliva-Pascual-Vaca, Angel; Rodriguez-Blanco, Cleofás; Heredia-Rizo, Alberto Marcos; Ricard, François; Almazán-Campos, Ginés

    2014-09-01

    To evaluate the short-term effect on spinal mobility, pain perception, neural mechanosensitivity, and full height recovery after high-velocity, low-amplitude (HVLA) spinal manipulation (SM) in the lumbosacral joint (L5-S1). Randomized, double-blind, controlled clinical trial with evaluations at baseline and after intervention. University-based physical therapy research clinic. Men (N=40; mean age ± SD, 38 ± 9.14 y) with diagnosed degenerative lumbar disease at L5-S1 were randomly divided into 2 groups: a treatment group (TG) (n=20; mean age ± SD, 39 ± 9.12 y) and a control group (CG) (n=20; mean age ± SD, 37 ± 9.31 y). All participants completed the intervention and follow-up evaluations. A single L5-S1 SM technique (pull-move) was performed in the TG, whereas the CG received a single placebo intervention. Measures included assessing the subject's height using a stadiometer. The secondary outcome measures included perceived low back pain, evaluated using a visual analog scale; neural mechanosensitivity, as assessed using the passive straight-leg raise (SLR) test; and amount of spinal mobility in flexion, as measured using the finger-to-floor distance (FFD) test. The intragroup comparison indicated a significant improvement in all variables in the TG (Pperceived pain, spinal mobility in flexion, hip flexion during the passive SLR test, and subjects' full height. Future studies should include women and should evaluate the long-term results. Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  13. A randomized, double blind, cross-over, placebo-controlled clinical trial to assess the effects of Candesartan on the insulin sensitivity on non diabetic, non hypertense subjects with dysglyce mia and abdominal obesity. "ARAMIA"

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    Rueda-Clausen Christian F

    2006-09-01

    Full Text Available Abstract Background The raising prevalence of type-2 diabetes mellitus and obesity has been recognized as a major problem for public health, affecting both developed and developing countries. Impaired fasting plasma glucose has been previously associated with endothelial dysfunction, higher levels of inflammatory markers and increased risk of developing insulin resistance and cardiovascular events. Besides life-style changes, the blockade of the renin-angiotensin system has been proposed as a useful alternative intervention to improve insulin resistance and decrease the number of new type-2 diabetes cases. The aim of this clinical trial is to study the effect of the treatment with Candesartan, an angiotensin II receptor antagonist, on the insulin resistance, the plasma levels of adipoquines, oxidative stress and prothrombotic markers, in a group of non diabetic, non hypertensive, dysglycemic and obese subjects. Methods and design A randomized, double blind, cross-over, placebo-controlled, clinical trial was designed to assess the effects of Candesartan (up to 32 mg/day during 6 months on the Homeostasis Model Assessment (HOMA index, lipid profile, protrombotic state, oxidative stress and plasma levels of inflammatory markers. The participants will be recruited in the "Fundación Cardiovascular de Colombia". Subjects who fullfil selection criteria will receive permanent educational, nutritional and exercise support during their participation in the study. After a 15 days-run-in period with placebo and life-style recommendations, the patients who have a treatment compliance equal or greater than 80% will be randomlly assigned to one of the treatment groups. Group A will receive Candesartan during 6 months and placebo during 6 months. Group B will receive placebo during the first 6 months, and then, Candesartan during the last 6 months. Control visits will be programed monthly and all parameters of interest will be evaluated every 6 months

  14. Effects of a program to prevent social isolation on loneliness, depression, and subjective well-being of older adults: a randomized trial among older migrants in Japan.

    Science.gov (United States)

    Saito, Tami; Kai, Ichiro; Takizawa, Ayako

    2012-01-01

    Social isolation among the elderly is a concern in developed countries. Using a randomized trial, this study examined the effect of a social isolation prevention program on loneliness, depression, and subjective well-being of the elderly in Japan. Among the elderly people who relocated to suburban Tokyo, 63 who responded to a pre-test were randomized and assessed 1 and 6 months after the program. Four sessions of a group-based program were designed to prevent social isolation by improving community knowledge and networking with other participants and community "gatekeepers." The Life Satisfaction Index A (LSI-A), Geriatric Depression Scale (GDS), Ando-Osada-Kodama (AOK) loneliness scale, social support, and other variables were used as outcomes of this study. A linear mixed model was used to compare 20 of the 21 people in the intervention group to 40 of the 42 in the control group, and showed that the intervention program had a significant positive effect on LSI-A, social support, and familiarity with services scores and a significant negative effect on AOK over the study period. The program had no significant effect on depression. The findings of this study suggest that programs aimed at preventing social isolation are effective when they utilize existing community resources, are tailor-made based on the specific needs of the individual, and target people who can share similar experiences. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  15. The effect of nano-curcumin on HbA1c, fasting blood glucose, and lipid profile in diabetic subjects: a randomized clinical trial

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    Hamid Reza Rahimi

    2016-08-01

    Full Text Available Objective: Diabetes mellitus is defined as a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both or insulin resistance. Curcumin inhibits NF-κB signaling pathway. The aim of this study is evaluation of the effect of Nano-curcumin on HbA1C, fast blood glucose and lipid profile in diabetic patients. Materials and Methods: Seventy type-2 diabetic patients (fasting blood glucose (FBG ≥ 126 mg/dL or 2-hr postprandial blood glucose ≥200 mg/dl randomly receivedeither Curcumin (as nano-micelle 80 mg/day or placebo for 3 months in a double blind randomized clinical trial. Fasting blood glucose, HbA1C, and lipids profile were checked before and after the intervention. Data analyses, including parametric and nonparametric tests were done using the SPSS 11.5 software. A p value < 0.05 was regarded as statistically significant. (RCT registration code: IRCT2013081114330N1 Results: Mean age, BMI, FBG, total cholesterol (TC, triglyceride (TG, LDL, HDL, HbA1c , and  sex and had no significant difference at the baseline between the groups. In Nano-curcumin group, a significant decrease was found in HbA1C, FBG, TG, and BMI comparing results of each subject before and after the treatment (p

  16. A randomized, double-blind, placebo-controlled study evaluating the effects of quercetin-rich onion on cognitive function in elderly subjects

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    Mie Nishimura

    2017-05-01

    Full Text Available Background: Quercetin, a phenolic compound, exhibits various functional effectsthat includeanti-oxidant, anti-dyslipidemic, and anti-dysglycemic activities, in addition tobeneficial effects on cognitive function. We evaluated the effects of a powder made from quercetin-rich onions (‘Quergold’ and ‘Sarasara-gold’ on cognitive function.Methods:In this randomized, double-blind, placebo-controlled study, we randomized 50 adults (25 males and 25 females, aged 65–84 years and made them consume products made from quercetin-rich (active test food group or quercetin-free(placebo food group onions. Cognitive function,hematological, and biological examinations were performed at the beginning (week 0 of the study and at weeks 12 and 24 after the start of the study. Results:There were no differences in the Mini-Mental State Examination (MMSE and cognitive impairment rating scale scores between the two groups. However, in younger subjects, the MMSE scores were significantly higher in the active test food group than in the placebo food group at week 24 (p = 0.019. Conclusion: These results suggest that the ingestion of quercetin-rich onions improves cognitive function and reduce cognitive declinein elderly people.

  17. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial

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    Arce Roger M

    2011-02-01

    Full Text Available Abstract Background Periodontal disease (PD is an infectious clinical entity characterized by the destruction of supporting tissues of the teeth as the result of a chronic inflammatory response in a susceptible host. It has been proposed that PD as subclinical infection may contribute to the etiology and to the pathogenesis of several systemic diseases including Atherosclerosis. A number of epidemiological studies link periodontal disease/edentulism as independent risk factor for acute myocardial infarction, peripheral vascular disease, and cerebrovascular disease. Moreover, new randomized controlled clinical trials have shown an improvement on cardiovascular surrogate markers (endothelial function, sICAM, hsPCR level, fibrinogen after periodontal treatment. Nonetheless, such trials are still limited in terms of external validity, periodontal treatment strategies, CONSORT-based design and results consistency/extrapolation. The current study is designed to evaluate if periodontal treatment with scaling and root planning plus local delivered chlorhexidine improves endothelial function and other biomarkers of cardiovascular disease in subjects with moderate to severe periodontitis. Methods/Design This randomized, single-blind clinical trial will be performed at two health centers and will include two periodontal treatment strategies. After medical/periodontal screening, a baseline endothelium-dependent brachial artery flow-mediated dilatation (FMD and other systemic surrogate markers will be obtained from all recruited subjects. Patients then will be randomized to receive either supragingival/subgingival plaque cleaning and calculus removal plus chlorhexidine (treatment group or supragingival plaque removal only (control group. A second and third FMD will be obtained after 24 hours and 12 weeks in both treatment arms. Each group will consist of 49 patients (n = 98 and all patients will be followed-up for secondary outcomes and will be monitored

  18. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial

    Science.gov (United States)

    2011-01-01

    Background Periodontal disease (PD) is an infectious clinical entity characterized by the destruction of supporting tissues of the teeth as the result of a chronic inflammatory response in a susceptible host. It has been proposed that PD as subclinical infection may contribute to the etiology and to the pathogenesis of several systemic diseases including Atherosclerosis. A number of epidemiological studies link periodontal disease/edentulism as independent risk factor for acute myocardial infarction, peripheral vascular disease, and cerebrovascular disease. Moreover, new randomized controlled clinical trials have shown an improvement on cardiovascular surrogate markers (endothelial function, sICAM, hsPCR level, fibrinogen) after periodontal treatment. Nonetheless, such trials are still limited in terms of external validity, periodontal treatment strategies, CONSORT-based design and results consistency/extrapolation. The current study is designed to evaluate if periodontal treatment with scaling and root planning plus local delivered chlorhexidine improves endothelial function and other biomarkers of cardiovascular disease in subjects with moderate to severe periodontitis. Methods/Design This randomized, single-blind clinical trial will be performed at two health centers and will include two periodontal treatment strategies. After medical/periodontal screening, a baseline endothelium-dependent brachial artery flow-mediated dilatation (FMD) and other systemic surrogate markers will be obtained from all recruited subjects. Patients then will be randomized to receive either supragingival/subgingival plaque cleaning and calculus removal plus chlorhexidine (treatment group) or supragingival plaque removal only (control group). A second and third FMD will be obtained after 24 hours and 12 weeks in both treatment arms. Each group will consist of 49 patients (n = 98) and all patients will be followed-up for secondary outcomes and will be monitored through a coordinating

  19. Short term non-invasive ventilation post-surgery improves arterial blood-gases in obese subjects compared to supplemental oxygen delivery - a randomized controlled trial

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    Zoremba Norbert

    2011-05-01

    Full Text Available Abstract Background In the immediate postoperative period, obese patients are more likely to exhibit hypoxaemia due to atelectasis and impaired respiratory mechanics, changes which can be attenuated by non-invasive ventilation (NIV. The aim of the study was to evaluate the duration of any effects of early initiation of short term pressure support NIV vs. traditional oxygen delivery via venturi mask in obese patients during their stay in the PACU. Methods After ethics committee approval and informed consent, we prospectively studied 60 obese patients (BMI 30-45 undergoing minor peripheral surgery. Half were randomly assigned to receive short term NIV during their PACU stay, while the others received routine treatment (supplemental oxygen via venturi mask. Premedication, general anaesthesia and respiratory settings were standardized. We measured arterial oxygen saturation by pulse oximetry and blood gas analysis on air breathing. Inspiratory and expiratory lung function was measured preoperatively (baseline and at 10 min, 1 h, 2 h, 6 h and 24 h after extubation, with the patient supine, in a 30 degrees head-up position. The two groups were compared using repeated-measure analysis of variance (ANOVA and t-test analysis. Statistical significance was considered to be P Results There were no differences at the first assessment. During the PACU stay, pulmonary function in the NIV group was significantly better than in the controls (p Conclusion Early initiation of short term NIV during in the PACU promotes more rapid recovery of postoperative lung function and oxygenation in the obese. The effect lasted 24 hours after discontinuation of NIV. Patient selection is necessary in order to establish clinically relevant improvements. Trial Registration# DRKS00000751; http://www.germanctr.de

  20. Camelina Sativa Oil, but not Fatty Fish or Lean Fish Improved Serum Lipid Profile in Subjects with Impaired Glucose Metabolism - a Randomized Controlled Trial.

    Science.gov (United States)

    Schwab, Ursula S; Lankinen, Maria A; de Mello, Vanessa D; Manninen, Suvi M; Kurl, Sudhir; Pulkki, Kari J; Laaksonen, David E; Erkkilä, Arja T

    2017-12-22

    The aim of the study was to examine whether lean fish (LF), fatty fish (FF) and camelina sativa oil (CSO), a plant-based source of alpha-linolenic acid (ALA), differ in their metabolic effects in subjects with impaired glucose metabolism. Altogether 79 volunteers with impaired fasting glucose, BMI 25-36 kg/m2 , age 43-72 years, participated in a 12-week randomized controlled trial with four parallel groups, i.e. the FF (4 fish meals/week), LF (4 fish meals/week), CSO (10 g/day ALA) and control (limited intakes of fish and source of ALA) groups. The proportions of EPA and DHA increased in plasma lipids in the FF group, and the proportion of ALA increased in the CSO group (P < 0.0001 for all). In the CSO group total and LDL-cholesterol (C) concentrations decreased compared with the FF and LF groups, LDL-C/HDL-C and ApoB/ApoA-I ratios decreased compared with the LF group. There were no significant changes in glucose metabolism or markers of low-grade inflammation. A diet enriched in CSO improves serum lipid profile as compared with a diet enriched in FF or LF in subjects with impaired fasting glucose, with no differences in glucose metabolism or concentrations of inflammatory markers. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  1. Absence of a significant pharmacokinetic interaction between atorvastatin and fenofibrate: A randomized, crossover, study of a fixed-dose formulation in healthy Mexican subjects

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    Omar ePatiño-Rodríguez

    2015-01-01

    Full Text Available Several clinical trials have substantiated the efficacy of the co-administration of statins like atorvastatin and fibrates. Without information currently available about the interaction between the two drugs, a pharmacokinetic study was conducted to investigate the effect when both drugs were co-administered. The purpose of this study was to investigate the pharmacokinetic profile of tablets containing atorvastatin 20 mg, or the combination of atorvastatin 20 mg with fenofibrate 160 mg administered to healthy Mexican volunteers. This was a randomized, two-period, two-sequence, crossover study; 36 eligible subjects aged between 20 to 50 years were included. Blood samples were collected up to 96 h after dosing, and pharmacokinetic parameters were obtained by non-compartmental analysis. Adverse events were evaluated based on subject interviews and physical examinations. Area under the concentration-time curve (AUC and maximum plasma drug concentration (Cmax were measured for atorvastatin as the reference and atorvastatin and fenofibrate as the test product for bioequivalence design. The estimation computed (90% confidence intervals for atorvastatin and fenofibrate combination versus atorvastatin for Cmax, AUC0-t and AUC0-∞, were 102,09, 125,95 and 120,97% respectively. These results suggest that atorvastatin and fenofibrate have no relevant clinical-pharmacokinetic drug interaction.

  2. Acute and chronic effects of flavanol-rich cocoa on vascular function in subjects with coronary artery disease: a randomized double-blind placebo-controlled study.

    Science.gov (United States)

    Farouque, H M Omar; Leung, Michael; Hope, Sarah A; Baldi, Mauro; Schechter, Clyde; Cameron, James D; Meredith, Ian T

    2006-07-01

    Evidence suggests that flavonoid-containing diets reduce cardiovascular risk, but the mechanisms responsible are unclear. In the present study, we sought to determine the effect of flavanol-rich cocoa on vascular function in individuals with CAD (coronary artery disease). Forty subjects (61+/-8 years; 30 male) with CAD were recruited to a 6-week randomized double-blind placebo-controlled study. Subjects consumed either a flavanol-rich chocolate bar and cocoa beverage daily (total flavanols, 444 mg/day) or matching isocaloric placebos daily (total flavanols, 19.6 mg/day) for 6 weeks. Brachial artery FMD (flow-mediated dilation) and SAC (systemic arterial compliance) were assessed at baseline, 90 min following the first beverage and after 3 and 6 weeks of daily consumption. Soluble cellular adhesion molecules and FBF (forearm blood flow) responses to ACh (acetylcholine chloride; 3-30 microg/min) and SNP (sodium nitroprusside; 0.3-3 microg/min) infusions, forearm ischaemia and isotonic forearm exercise were assessed at baseline and after 6 weeks. FMD, SAC and FBF responses did not differ between groups at baseline. No acute or chronic changes in FMD or SAC were seen in either group. No difference in soluble cellular adhesion molecules, FBF responses to ischaemia, exercise, SNP or ACh was seen in the group receiving flavanol-rich cocoa between baseline and 6 weeks. These data suggest that over a 6-week period, flavanol-rich cocoa does not modify vascular function in patients with established CAD.

  3. A randomized, single-blind, Phase I trial (INVICTAN-1) assessing the bioequivalence and safety of BI 695502, a bevacizumab biosimilar candidate, in healthy subjects.

    Science.gov (United States)

    Hettema, Willem; Wynne, Christopher; Lang, Benjamin; Altendorfer, Mario; Czeloth, Niklas; Lohmann, Ragna; Athalye, Sandeep; Schliephake, Dorothee

    2017-08-01

    This Phase I trial (INVICTAN®-1) evaluated three-way bioequivalence and safety of BI 695502 a bevacizumab biosimilar candidate, and reference product bevacizumab from two sources (US-approved Avastin®, Genentech; EU-approved Avastin, Roche). Healthy male subjects (N = 91) were randomized 1:1:1 to receive a single intravenous infusion of 1 mg/kg of BI 695502 or US- or EU-approved Avastin. An interim analysis was planned when ~50% of subjects were evaluable for the primary end point to determine if the prespecified criteria for bioequivalence were achieved; if demonstrated, the study could be stopped early. The primary end point was area under the concentration-time curve (AUC) of the analyte in plasma from time zero extrapolated to infinity (AUC0-∞). Other pharmacokinetic (PK) parameters, safety, and in vitro binding affinity were also evaluated. The interim analysis demonstrated three-way bioequivalence for all comparisons. The confidence intervals around the geometric mean ratios of the primary and secondary PK parameters were within the predefined acceptance ranges. Study drugs were well tolerated with no clinically relevant differences in safety. BI 695502 and US- and EU-approved Avastin showed three-way bioequivalence with similar safety profile. NCT01608087.

  4. Proarrhythmic safety of repeat doses of mirabegron in healthy subjects: a randomized, double-blind, placebo-, and active-controlled thorough QT study.

    Science.gov (United States)

    Malik, M; van Gelderen, E M; Lee, J H; Kowalski, D L; Yen, M; Goldwater, R; Mujais, S K; Schaddelee, M P; de Koning, P; Kaibara, A; Moy, S S; Keirns, J J

    2012-12-01

    Potential effects of the selective β(3)-adrenoceptor agonist mirabegron on cardiac repolarization were studied in healthy subjects. The four-arm, parallel, two-way crossover study was double-blind and placebo- and active (moxifloxacin)-controlled. After 2 baseline ECG days, subjects were randomized to one of eight treatment sequences (22 females and 22 males per sequence) of placebo crossed over with once-daily (10 days) 50, 100, or 200 mg mirabegron or a single 400-mg moxifloxacin dose on day 10. In each period, continuous ECGs were recorded at two baselines and on the last drug administration day. The lower one-sided 95% confidence interval for moxifloxacin effect on QTcI was >5 ms, demonstrating assay sensitivity. According to ICH E14 criteria, mirabegron did not cause QTcI prolongation at the 50-mg therapeutic and 100-mg supratherapeutic doses in either sex. Mirabegron prolonged QTcI interval at the 200-mg supratherapeutic dose (upper one-sided 95% CI >10 ms) in females, but not in males.

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

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    Jingfen Zhu

    2016-01-01

    Full Text Available 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.

  6. Cognitive effects of oxybutynin chloride topical gel in older healthy subjects: a 1-week, randomized, double-blind, placebo- and active-controlled study.

    Science.gov (United States)

    Kay, Gary G; Staskin, David R; MacDiarmid, Scott; McIlwain, Marilyn; Dahl, Naomi V

    2012-10-01

    Oxybutynin is a common antimuscarinic therapy for overactive bladder. Transdermally administered oxybutynin chloride topical gel 10% (OTG) has a low propensity for anticholinergic adverse effects and possibly also a low risk of cognitive impairment. A randomized, double-blind, placebo- and active-controlled study evaluated the effects of OTG on cognitive and psychomotor functions in older healthy adults. Healthy adults aged 60-79 years were assigned randomly (1:1:1) to 1-week's treatment with OTG (1 g [100 mg oxybutynin] applied once daily on rotating sites of upper arms/shoulders, abdomen or thighs) plus oral placebo, immediate-release oxybutynin (OXB-IR; 5 mg capsule three times/day) plus placebo gel, or double placebo. Delayed recall Name-Face Association Test (NFAT) score was the primary end point. Treatments were compared by analysis of covariance. Of 152 participants (mean age, 68 years), 49 received OTG, 52 OXB-IR and 51 placebo. NFAT Delayed Recall tests revealed no significant treatment differences (overall, p = 0.2733; OTG vs placebo, p = 0.1551; OXB-IR vs placebo, p = 0.1767). However, a significant effect (p = 0.0294) was noted for the Misplaced Objects Test, with scores declining only for OXB-IR. Approximately twice as many participants receiving OXB-IR (n = 10) as those receiving OTG (n = 5) or placebo (n = 6) showed a significant decline (≥6 points) in Total Recall score for the Hopkins Verbal Learning Test-Revised. No significant effects on psychomotor reaction time were observed. The most common adverse event, dry mouth, occurred in 6.1%, 73.1% and 7.8% of participants receiving OTG, OXB-IR and placebo, respectively. OTG applied for 1 week had no clinically meaningful effect on recent memory or other cognitive functions in healthy, older adults. Registered as NCT00752141 at www.clinicaltrials.gov.

  7. Pharmacokinetics and tolerability of inhaled umeclidinium and vilanterol alone and in combination in healthy Chinese subjects: a randomized, open-label, crossover trial.

    Directory of Open Access Journals (Sweden)

    Chaoying Hu

    Full Text Available Inhaled umeclidinium (UMEC and the combination of inhaled UMEC with vilanterol (UMEC/VI are approved maintenance treatments for chronic obstructive pulmonary disease in the US and EU. This was a randomized, open-label, three-period crossover, single- and repeat-dose study to assess the pharmacokinetics (PK, safety, and tolerability of inhaled UMEC/VI 62.5/25 μg (delivering 55/22 μg and UMEC/VI 125/25 μg (delivering 113/22 μg compared with their monotherapy components (UMEC 62.5 μg, UMEC 125 μg and, VI 25 μg [delivering 55, 113, and 22 μg, respectively] in healthy Chinese subjects (n=20. UMEC and VI were rapidly absorbed following single and repeat dosing (time to maximum plasma concentration [tmax]: UMEC = 5 min; VI = 5 min. The median tlast was 2–4 h for UMEC and 1–2 h for VI following single doses of UMEC/VI and UMEC monotherapy (both doses. UMEC reached steady-state prior to Day 10; steady-state for VI could not be assessed. UMEC accumulation following repeat dosing was 11–34% based on Cmax and 19–59% based on area under the concentration-time curve from time zero to 2 h (AUC(0-2. VI accumulation following repeat dosing was 25–66% based on Cmax and 17–43% based on AUC(0-2. The evidence was not sufficient to suggest that systemic exposure was substantially different between UMEC/VI combination therapy and the constituent monotherapies following single or repeat dosing. Following both single- and repeat-dose administration, the inter-subject coefficient of variation for all UMEC PK parameter estimates ranged from 12% to 165% for all treatments, indicating a wide range of variability in inhaled PK parameters. Twelve subjects experienced ≥1 adverse event (AE. Six subjects experienced ≥1 treatment-related AE; the most commonly reported treatment-related AE was chest discomfort (n=3 [15%]. No clinically important changes in vital signs or electrocardiogram parameters were reported. These data suggest that single- and repeat

  8. Pharmacokinetics and tolerability of inhaled umeclidinium and vilanterol alone and in combination in healthy Chinese subjects: a randomized, open-label, crossover trial.

    Science.gov (United States)

    Hu, Chaoying; Jia, Jingying; Dong, Kelly; Luo, Linda; Wu, Kai; Mehta, Rashmi; Peng, Jack; Ren, Yan; Gross, Annette; Yu, Hui

    2015-01-01

    Inhaled umeclidinium (UMEC) and the combination of inhaled UMEC with vilanterol (UMEC/VI) are approved maintenance treatments for chronic obstructive pulmonary disease in the US and EU. This was a randomized, open-label, three-period crossover, single- and repeat-dose study to assess the pharmacokinetics (PK), safety, and tolerability of inhaled UMEC/VI 62.5/25 μg (delivering 55/22 μg) and UMEC/VI 125/25 μg (delivering 113/22 μg) compared with their monotherapy components (UMEC 62.5 μg, UMEC 125 μg and, VI 25 μg [delivering 55, 113, and 22 μg, respectively]) in healthy Chinese subjects (n=20). UMEC and VI were rapidly absorbed following single and repeat dosing (time to maximum plasma concentration [tmax]: UMEC = 5 min; VI = 5 min). The median tlast was 2–4 h for UMEC and 1–2 h for VI following single doses of UMEC/VI and UMEC monotherapy (both doses). UMEC reached steady-state prior to Day 10; steady-state for VI could not be assessed. UMEC accumulation following repeat dosing was 11–34% based on Cmax and 19–59% based on area under the concentration-time curve from time zero to 2 h (AUC(0-2)). VI accumulation following repeat dosing was 25–66% based on Cmax and 17–43% based on AUC(0-2). The evidence was not sufficient to suggest that systemic exposure was substantially different between UMEC/VI combination therapy and the constituent monotherapies following single or repeat dosing. Following both single- and repeat-dose administration, the inter-subject coefficient of variation for all UMEC PK parameter estimates ranged from 12% to 165% for all treatments, indicating a wide range of variability in inhaled PK parameters. Twelve subjects experienced ≥1 adverse event (AE). Six subjects experienced ≥1 treatment-related AE; the most commonly reported treatment-related AE was chest discomfort (n=3 [15%]). No clinically important changes in vital signs or electrocardiogram parameters were reported. These data suggest that single- and repeat

  9. A randomized, double-blind, placebo-controlled phase 3 skin cancer prevention study of DFMO in subjects with previous history of skin cancer

    Science.gov (United States)

    Bailey, HH; Kim, K; Verma, A; Sielaff, K; Larson, PO; Snow, S; Lenaghan, T; Viner, JL; Douglass, J; Dreckschmidt, N; Hamielec, M; Pomplun, M; Sharata, HH; Puchalsky, D; Berg, ER; Havighurst, T; Carbone, PP

    2009-01-01

    Preclinical studies have shown the inhibition of ornithine decarboxylase (ODC) by α-difluoromethylornithine (DFMO) and resultant decreases in tissue concentrations of polyamines (putrescine & spermidine) prevents neoplastic developments in many tissue types. Clinical studies of oral DFMO at 500 mg/m2/day revealed it to be safe and tolerable and resulted in significant inhibition of phorbol ester-induced skin ODC activity. Two hundred and ninety-one participants (mean 61 y.o., 60% male) with a history of prior non-melanoma skin cancer (mean 4.5 skin cancers) were randomized to oral DFMO (500 mg/m2/day) or placebo for 4–5 years. There was a trend toward a history of more prior skin cancers in subjects randomized to placebo, but all other characteristics including sunscreen and NSAID use were evenly distributed. Evaluation of 1200-person years of follow-up revealed a new non-melanoma skin cancer (NMSC) rate of 0.5 events/person/year. The primary endpoint, new NMSC’s, was not significantly different between subjects taking DFMO and placebo (260 vs. 363 cancers, p=0.069, two-sample t test). Evaluation of basal cell (BCC) and squamous cell (SCC) cancers separately revealed very little difference in SCC between treatment groups but a significant difference in new BCC (DFMO 163 cancers; Placebo 243 cancers; expressed as event rate 0.28 BCC/person/year vs. 0.40 BCC/person/year, p=0.03). Compliance with DFMO was >90% and it appeared to be well tolerated with evidence of mild ototoxicity as measured by serial audiometric examination when compared to placebo subjects. Analysis of normal skin biopsies revealed a significant (pskin cancer taking daily DFMO had an insignificant reduction (p=0.069), in new NMSC that was predominantly due to a marked reduction in new BCC. Based on these data, the potential of DFMO, alone or in combination, to prevent skin cancers should be explored further. PMID:20051371

  10. Comparison of a Novel Formulation of Abiraterone Acetate vs. the Originator Formulation in Healthy Male Subjects: Two Randomized, Open-Label, Crossover Studies.

    Science.gov (United States)

    Goldwater, Ronald; Hussaini, Azra; Bosch, Bill; Nemeth, Paul

    2017-07-01

    Abiraterone acetate is approved for the treatment of metastatic castration-resistant prostate cancer. The originator abiraterone acetate (OAA) formulation is poorly absorbed and exhibits large pharmacokinetic variability in abiraterone exposure. Abiraterone acetate fine particle (AAFP) is a proprietary formulation (using SoluMatrix Fine Particle Technology™) designed to increase the oral bioavailability of abiraterone acetate. Here, we report on two phase I studies in healthy male subjects aged 18-50 years. In Study 101, 20 subjects were randomized in a crossover design to single doses of AAFP 100, 200, or 400 mg or OAA 1000 mg taken orally under fasting conditions. Results suggested that AAFP 500 mg would be bioequivalent to OAA 1000 mg in the fasted state. To confirm the bioequivalence hypothesis and to further expand the AAFP dose range, in Study 102, 36 subjects were randomized in a crossover design to single doses of AAFP 125, 500, or 625 mg or OAA 1000 mg. Both studies included a 7-day washout period between administrations. Dose-dependent increases in the area under the plasma concentration-time curve and maximum plasma concentration with AAFP were observed in both studies. The AAFP 500-mg bioavailability relative to OAA 1000 mg measured by the geometric mean ratio for area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration was 93.4% (90% confidence interval 85.3-102.4), area under the plasma concentration-time curve from time zero to infinity was 91.0% (90% confidence interval 83.3-99.4), and maximum plasma concentration was 99.8% (90% confidence interval 86.3-115.5). Dose proportionality was seen across all AAFP dose levels (100-625 mg). Abiraterone acetate fine particle was found to be safe and well tolerated in this study. Abiraterone acetate fine particle 500 mg was demonstrated to be bioequivalent to OAA 1000 mg in healthy volunteers under fasted conditions.

  11. A randomized, double-blind, placebo-controlled, dose-response study to assess the pharmacokinetics, efficacy, and safety of gabapentin enacarbil in subjects with restless legs syndrome.

    Science.gov (United States)

    Lal, Ritu; Ellenbogen, Aaron; Chen, Dan; Zomorodi, Katie; Atluri, Harisha; Luo, Wendy; Tovera, James; Hurt, Janet; Bonzo, Daniel; Lassauzet, Marie-Liesse; Vu, Amanda; Cundy, Kenneth C

    2012-01-01

    The objective of this study was to determine steady-state gabapentin exposures and corresponding relief of symptoms and safety profile produced by 4 dose levels of gabapentin enacarbil (GEn) in subjects with restless legs syndrome (RLS). Subjects with RLS (n = 217) were randomized to receive once-daily, orally administered GEn 600 (n = 48), 1200 (n = 45), 1800 (n = 38), or 2400 mg (n = 45) or placebo (n = 41) in this 12-week, double-blind, multicenter study (NCT01332305). Clinic visits were at screening, baseline, and weeks 1, 2, 3, 4, 6, 8, 10, and 12; plasma gabapentin concentrations were measured by a validated liquid chromatography-mass spectrometry/mass spectrometry method at weeks 4 and 12. Exposure to gabapentin was proportional to GEn dose. Time to maximum plasma concentration was 7 to 9 hours, and elimination half-life was ~6 hours. The mean reduction from baseline to week 12 in International Restless Legs Syndrome Rating Scale total score and proportions of subjects with "much improved"/"very much improved" Clinical Global Impression-Improvement scores (investigator and patient ratings) ranged from -12.9 to -13.9 for GEn treatment groups versus -9.3 for placebo. The 2 most commonly reported adverse events were somnolence and dizziness. Gabapentin exposure was approximately proportional to GEn dose. Efficacy data showed that a once-daily dose of GEn 600 to 2400 mg provides greater relief of RLS symptoms than placebo; GEn was generally well tolerated with an adverse event profile consistent with gabapentin.

  12. Effect of Febuxostat on Ambulatory Blood Pressure in Subjects With Hyperuricemia and Hypertension: A Phase 2 Randomized Placebo-Controlled Study.

    Science.gov (United States)

    Gunawardhana, Lhanoo; McLean, Lachy; Punzi, Henry A; Hunt, Barbara; Palmer, Robert N; Whelton, Andrew; Feig, Daniel I

    2017-11-04

    Hyperuricemia is associated with hypertension, with elevated serum uric acid levels postulated to have a causal role in the development of hypertension. Consequently, serum uric acid reduction may help lower blood pressure (BP). A Phase 2, double-blind, placebo-controlled trial was conducted to assess the potential BP-lowering effects of the xanthine oxidase inhibitor febuxostat in subjects with hypertension and hyperuricemia (serum uric acid ≥0.42 mmol/L [≥7.0 mg/dL]). Subjects (n=121) were randomized 1:1 to febuxostat 80 mg once daily or to placebo. The primary end point was change from baseline to Week 6 in 24-hour mean ambulatory systolic BP (SBP). Additional end points included the following: change from baseline to Week 3 in 24-hour mean SBP and changes from baseline to Weeks 3 and 6 in 24-hour mean ambulatory diastolic BP, serum uric acid, mean daytime and nighttime ambulatory SBP/diastolic BP, and clinic SBP/diastolic BP. For the overall study population, there were no significant differences between febuxostat and placebo for changes from baseline to Weeks 3 or 6 in ambulatory, daytime or nighttime, or clinic SBP or diastolic BP. However, in a preplanned subgroup analysis, there was a significant decrease in SBP from baseline to Week 6 in subjects with normal renal function (estimated glomerular filtration rate ≥90 mL/min) treated with febuxostat versus placebo; least squares mean difference, -6.7; 95% confidence interval -13.3 to -0.0; P=0.049. This study suggests that febuxostat may lower BP in hyperuricemic patients with hypertension and normal renal function; further studies should be conducted to confirm this finding. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01496469. © 2017 The Authors and Takeda Pharmaceuticals. Published on behalf of the American Heart Association, Inc., by Wiley.

  13. Students' Achievement and Homework Assignment Strategies.

    Science.gov (United States)

    Fernández-Alonso, Rubén; Álvarez-Díaz, Marcos; Suárez-Álvarez, Javier; Muñiz, José

    2017-01-01

    The optimum time students should spend on homework has been widely researched although the results are far from unanimous. The main objective of this research is to analyze how homework assignment strategies in schools affect students' academic performance and the differences in students' time spent on homework. Participants were a representative sample of Spanish adolescents (N = 26,543) with a mean age of 14.4 (±0.75), 49.7% girls. A test battery was used to measure academic performance in four subjects: Spanish, Mathematics, Science, and Citizenship. A questionnaire allowed the measurement of the indicators used for the description of homework and control variables. Two three-level hierarchical-linear models (student, school, autonomous community) were produced for each subject being evaluated. The relationship between academic results and homework time is negative at the individual level but positive at school level. An increase in the amount of homework a school assigns is associated with an increase in the differences in student time spent on homework. An optimum amount of homework is proposed which schools should assign to maximize gains in achievement for students overall.

  14. The Effect of Cumin cyminum L. Plus Lime Administration on Weight Loss and Metabolic Status in Overweight Subjects: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    Taghizadeh, Mohsen; Memarzadeh, Mohammad Reza; Abedi, Fatemeh; Sharifi, Nasrin; Karamali, Fatemeh; Fakhrieh Kashan, Zohreh; Asemi, Zatollah

    2016-08-01

    Limited data are available regarding the effects of combined administration of Cumin cyminum L. and lime on weight loss and metabolic profiles among subjects with overweight subjects. The current study aimed to assess the effects of combined administration of Cumin cyminum L. and lime on weight loss and metabolic profiles among subjects with overweight. This randomized double-blind placebo-controlled clinical trial was conducted on 72 subjects with overweight, aged 18 - 50 years old. Participants were randomly divided into three groups: Group A received high-dose Cumin cyminum L. and lime capsules (75 mg each, n = 24), group B low-dose Cumin cyminum L. and lime capsules (25 mg each, n = 24) and group C placebos (n = 24) twice daily for eight weeks. After eight weeks of intervention, compared with low-dose C. cyminum L. plus lime and placebo, taking high-dose C. cyminum L. plus lime resulted in significant weight loss (in the high-dose group: -2.1 ± 1.7 vs. in the low-dose group: -1.2 ± 1.5 and in the placebo group: + 0.2 ± 1.3 kg, respectively; P < 0.001) and body mass index (-0.8 ± 0.6 vs. -0.5 ± 0.5 and +0.1 ± 0.5 kg/m(2), respectively; P < 0.001). In addition, administration of high-dose C. cyminum L. plus lime compared with low-dose C. cyminum L. plus lime and placebo, led to a significant reduction in fasting plasma glucose (FPG) (P < 0.001) and a significant rise in quantitative insulin sensitivity check index (QUICKI) (+ 0.02 ± 0.02 vs. + 0.01 ± 0.02 and 0.01 ± 0.01, respectively; P = 0.01). Moreover, a significant decrease in serum triglycerides (-14.1 ± 56.2 vs. +13.9 ± 36.8 and + 10.6 ± 25.1 mg/dL; respectively; P = 0.03), total-cholesterol (-18.4 ± 28.6 vs. +8.6 ± 28.5 and -1.0 ± 24.8 mg/dL; respectively; P = 0.004) and low density lipoproteins- (LDL)-cholesterol levels (-11.8 ± 20.7 vs. +6.5 ± 23.2 and -2.9 ± 20.4 mg/dL, respectively; P = 0.01) was observed following the consumption of high-dose C. cyminum L. plus lime compared with

  15. Game theory and traffic assignment.

    Science.gov (United States)

    2013-09-01

    Traffic assignment is used to determine the number of users on roadway links in a network. While this problem has : been widely studied in transportation literature, its use of the concept of equilibrium has attracted considerable interest : in the f...

  16. An Assignment Sequence for Underprepared Writers.

    Science.gov (United States)

    Nimmo, Kristi

    2000-01-01

    Presents a sequenced writing assignment on shopping to aid basic writers. Describes a writing assignment focused around online and mail-order shopping. Notes steps in preparing for the assignment, the sequence, and discusses responses to the assignments. (SC)

  17. A double-blind, randomized, Phase III, multicenter study in 358 pediatric subjects receiving isotretinoin therapy demonstrates no effect on pediatric bone mineral density.

    Science.gov (United States)

    Hoover, K B; Miller, C G; Galante, N C; Langman, C B

    2015-10-01

    This study compared the effects of pediatric acne treatment with two isotretinoin formulations on bone mineral density. We demonstrated no difference in the effect of the two formulations. No effect on pediatric bone mineral density was identified for either formulation. Isotretinoin (13-cis-retinoic acid) is a treatment for recalcitrant nodular acne with a purported effect on bone mineral density (BMD). The side effects of isotretinoin on vertebral bone were evaluated to assess the safety of a new FDA-approved isotretinoin formulation: Lidose-isotretinoin (Cip-Iso). This double-blind, randomized, phase III, active control, parallel-group, multicenter study compared the safety, efficacy, and non-inferiority of CIP-Iso to a marketed reference product, Accutane®, in severe recalcitrant nodular acne subjects. Three hundred fifty-eight pediatric male and female subjects aged between 12 and 17 years underwent 20 weeks of treatment with PA lumbar spine dual X-ray absorptiometry (DXA) measurements obtained for bone mineral density (BMD) and Z-scores, 5.5 months apart on visits 1 and 8. One hundred sixty-eight of 358 subjects had height adjusted Z-scores (HAZ) calculated. There was no difference in the least squares (LS) mean Z-score or HAZ of the two drugs at visit 1 or 8. The mean and LS mean Z-score and HAZ were greater than zero at visits 1 and 8 for both drugs. The change in the LS mean spine Z-score, but not HAZ, between visits, was statistically significant for both drugs. There was a mean increase in BMD (g/cm(2)) for both products between visits. There is no difference in the effect of two formulations of isotretinoin on spine bone density after 6 months of treatment. BMD increased and the small change in spine Z-score over treatment disappeared after height adjustment. Mean positive Z-scores and HAZ in the study were likely due to the exclusion of low and inclusion of high Z-score subjects.

  18. Analgesic effect of cathodal transcranial current stimulation over right dorsolateral prefrontal cortex in subjects with muscular temporomandibular disorders: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Brandão Filho, Rivail Almeida; Baptista, Abrahão Fontes; Brandão, Renata de Assis Fonseca Santos; Meneses, Francisco Monteiro; Okeson, Jeffrey; de Sena, Eduardo Pondé

    2015-09-17

    Temporomandibular disorders are a group of orofacial pain conditions that are commonly identified in the general population. Like many other chronic pain conditions, they can be associated with anxiety/depression, which can be related to changes in the activity of the dorsolateral prefrontal cortex. Some studies have demonstrated clinical improvement in subjects with chronic pain who are given therapeutic neuromodulation. Transcranial direct current stimulation is a noninvasive brain stimulation technique that allows the modulation of neuronal membranes. This therapy can enhance or inhibit action potential generation in cortical neurons. In some instances, medications acting in the central nervous system may be helpful despite their adverse side effects. It is important to determine if cathodal transcranial direct current stimulation over the dorsolateral prefrontal cortex, an area that modulates emotion and motor cortex excitability, has an analgesic effect on chronic temporomandibular disorders pain. The investigators will run a randomized, controlled crossover double blind study with 15 chronic muscular temporomandibular disorder subjects. Each subject will undergo active (1 mA and 2 mA) and sham transcranial direct current stimulation. Inclusion criteria will be determined by the Research Diagnostic Criteria for Temporomandibular Disorders questionnaire, with subjects who have a pain visual analogic scale score of greater than 4/10 and whose pain has been present for the previous 6 months, and with a State-Trait Anxiety Inventory score of more than 42. The influence of transcranial direct current stimulation will be assessed through a visual analogic scale, quantitative sensory testing, quantitative electroencephalogram, and the State-Trait Anxiety Inventory score. Some studies have demonstrated a strong association between anxiety/depression and chronic pain, where one may be the cause of the other. This is especially true in chronic temporomandibular

  19. Effect of commercial breakfast fibre cereals compared with corn flakes on postprandial blood glucose, gastric emptying and satiety in healthy subjects: a randomized blinded crossover trial

    Directory of Open Access Journals (Sweden)

    Almér Lars-Olof

    2007-09-01

    Full Text Available Abstract Background Dietary fibre food intake is related to a reduced risk of developing diabetes mellitus. However, the mechanism of this effect is still not clear. The aim of this study was to evaluate the effect of commercial fibre cereals on the rate of gastric emptying, postprandial glucose response and satiety in healthy subjects. Methods Gastric emptying rate (GER was measured by standardized real time ultrasonography. Twelve healthy subjects were assessed using a randomized crossover blinded trial. The subjects were examined after an 8 hour fast and after assessment of normal fasting blood glucose level. Satiety scores were estimated and blood glucose measurements were taken before and at 0, 20, 30, 40, 60, 80, 100 and 120 min after the end of the meal. GER was calculated as the percentage change in the antral cross-sectional area 15 and 90 min after ingestion of sour milk with corn flakes (GER1, cereal bran flakes (GER2 or wholemeal oat flakes (GER3. Results The median value was, respectively, 42% for GER1, 33 % for GER2 and 51% for GER3. The difference between the GER after ingestion of bran flakes compared to wholemeal oat flakes was statistically significant (p = 0.023. The postprandial delta blood glucose level was statistically significantly lower at 40 min (p = 0.045 and 120 min (p = 0.023 after the cereal bran flakes meal. There was no statistical significance between the areas under the curve (AUCs of the cereals as far as blood glucose and satiety were concerned. Conclusion The result of this study demonstrates that the intake of either bran flakes or wholemeal oat flakes has no effect on the total postprandial blood glucose response or satiety when compared to corn flakes. However, the study does show that the intake of cereal bran flakes slows the GER when compared to oat flakes and corn flakes, probably due to a higher fibre content. Since these products do not differ in terms of glucose response and satiety on healthy

  20. [Correlation of subjective and objective assessment of vaginal prolapse surgery - secondary analysis of randomized controlled study in patients with pelvic floor injury treated with vaginal mesh or with sacrospinous ligament fixation].

    Science.gov (United States)

    Švabík, K; El Haddad, R; Mašata, J; Hubka, P; Martan, A

    2015-10-01

    We had provided secondary analysis of our randomized controlled study comparing vaginal mesh with sacrospinous fixation for vaginal prolapse. We correlated data from subjective and objective assessment. Secondly we had provided correlations results of subjective and objective assessment between patient with anatomical failure and those without. The aim of this analysis was to provide correlation between objective and subjective outcome measures. Subanalysis of randomized controlled study. Obstetric Gynecology Department, First Faculty of Medicine of Charles University and General University Hospital in Prague. This is secondary analysis of single center randomized controlled study comparing two standard procedures for vaginal prolapse after hysterectomy in patients with levator avulsion injury. We had analyzed pre- and postoperative subjective POPDI score (Pelvic Organ Prolapse Distress Inventory) and correlated this score with most prolapsed portion of vaginal wall. We had compared all vaginal compartments using POPQ (Pelvic Organ Prolapse Quantification): anterior wall with point Ba, apical with point C, and posterior with point Bp. Subsequently we compared subjective POPDI score in group of patients with anatomical failure and those without. We had included in randomized study 70 women. Mean preoperative POPDI score was 65.25 (3.57-200). We didnt found any correlation between subjective score and objective assessment in preoperative data: POPDI vs. Ba (p = 0.75) POPDI vs. C (p = 0.57) a POPDI vs. Bp (p = 0.22) and no correlation in postoperative assessment. Postoperative POPDI score decreased to 26.1, but there was no difference in POPDI score in woman with anatomical failure and no failure - 17.4 vs. 23.3 (p = 0.64)CONCLUSION: Secondary analysis of randomized controlled study had shown that objective and subjective assessment have poor correlation. We didnt found any correlation between degree of prolapse and intensity of complains. The large inter

  1. Both resistance training and aerobic training reduce hepatic fat content in type 2 diabetic subjects with nonalcoholic fatty liver disease (the RAED2 Randomized Trial).

    Science.gov (United States)

    Bacchi, Elisabetta; Negri, Carlo; Targher, Giovanni; Faccioli, Niccolò; Lanza, Massimo; Zoppini, Giacomo; Zanolin, Elisabetta; Schena, Federico; Bonora, Enzo; Moghetti, Paolo

    2013-10-01

    Although lifestyle interventions are considered the first-line therapy for nonalcoholic fatty liver disease (NAFLD), which is extremely common in people with type 2 diabetes, no intervention studies have compared the effects of aerobic (AER) or resistance (RES) training on hepatic fat content in type 2 diabetic subjects with NAFLD. In this randomized controlled trial, we compared the 4-month effects of either AER or RES training on insulin sensitivity (by hyperinsulinemic euglycemic clamp), body composition (by dual-energy X-ray absorptiometry), as well as hepatic fat content and visceral (VAT), superficial (SSAT), and deep (DSAT) subcutaneous abdominal adipose tissue (all quantified by an in-opposed-phase magnetic resonance imaging technique) in 31 sedentary adults with type 2 diabetes and NAFLD. After training, hepatic fat content was markedly reduced (P AER and the RES training groups (mean relative reduction from baseline [95% confidence interval] -32.8% [-58.20 to -7.52] versus -25.9% [-50.92 to -0.94], respectively). Additionally, hepatic steatosis (defined as hepatic fat content >5.56%) disappeared in about one-quarter of the patients in each intervention group (23.1% in the AER group and 23.5% in the RES group). Insulin sensitivity during euglycemic clamp was increased, whereas total body fat mass, VAT, SSAT, and hemoglobin A1c were reduced comparably in both intervention groups. This is the first randomized controlled study to demonstrate that resistance training and aerobic training are equally effective in reducing hepatic fat content among type 2 diabetic patients with NAFLD. Copyright © 2013 by the American Association for the Study of Liver Diseases.

  2. Acute effect of oatmeal on subjective measures of appetite and satiety compared to a ready-to-eat breakfast cereal: a randomized crossover trial.

    Science.gov (United States)

    Rebello, Candida J; Johnson, William D; Martin, Corby K; Xie, Wenting; O'Shea, Marianne; Kurilich, Anne; Bordenave, Nicolas; Andler, Stephanie; van Klinken, B Jan Willem; Chu, Yi-Fang; Greenway, Frank L

    2013-01-01

    The physicochemical properties of soluble oat fiber (β-glucan) affect viscosity-dependent mechanisms that influence satiety. The objective of this study was to compare the satiety impact of oatmeal with the most widely sold ready-to-eat breakfast cereal (RTEC) when either was consumed as a breakfast meal. Forty-eight healthy individuals ≥18 years of age were enrolled in a randomized crossover trial. Following an overnight fast, subjects consumed either oatmeal or RTEC in random order at least a week apart. The breakfasts were isocaloric and contained 363 kcal (250 kcal cereal, 113 kcal milk). Visual analogue scales measuring appetite and satiety were completed before breakfast and throughout the morning. The content and physicochemical properties of oat β-glucan were determined. Appetite and satiety responses were analyzed by area under the curve (AUC). Physicochemical properties were analyzed using t tests. Oatmeal, higher in fiber and protein but lower in sugar than the RTEC, resulted in greater increase in fullness (AUC: p = 0.005 [120 minute: p = 0.0408, 180 minute: p = 0.0061, 240 minute: p = 0.0102]) and greater reduction in hunger (AUC: p = 0.0009 [120 minute: p = 0.0197, 180 minute: p = 0.0003, 240 minute: p = 0.0036]), desire to eat (AUC: p = 0.0002 [120 minute: p = 0.0168, 180 minute: p Oatmeal had higher β-glucan content, higher molecular weight (p Oatmeal improves appetite control and increases satiety. The effects may be attributed to the viscosity and hydration properties of its β-glucan content.

  3. Oral intake of a combination of glucosyl hesperidin and caffeine elicits an anti-obesity effect in healthy, moderately obese subjects: a randomized double-blind placebo-controlled trial.

    Science.gov (United States)

    Ohara, Tatsuya; Muroyama, Koutarou; Yamamoto, Yoshihiro; Murosaki, Shinji

    2016-01-19

    We have previously shown that a combination of glucosyl hesperidin (G-hesperidin) plus caffeine reduces accumulation of body fat, whereas G-hesperidin or caffeine alone shows little effect on high-fat diet-induced obesity in mice. The aim of this study is to evaluate the anti-obesity effect of G-hesperidin plus caffeine on body fat and serum TG in healthy subjects with moderately high body mass index (BMI) and serum TG. Since we considered that there are individual differences in caffeine sensitivity, we conducted dose-finding study of caffeine combined with G-hesperidin. Seventy-five healthy subjects with moderately high BMI (24-30 kg/m(2)) and serum TG (100-250 mg/dl) were divided and assigned to 12-week intervention with daily intakes of 500 mg of G-hesperidin with or without 25, 50, or 75 mg of caffeine, or placebo in a randomized double-blind placebo-controlled design . After intervention, decreases in abdominal fat area (AFA), especially subcutaneous fat area (SFA), were significantly greater in the G-hesperidin with 50-mg caffeine group (AFA:-8.4 ± 21.9 v.s. 16.3 ± 34.1 cm(2); p hesperidin with 75-mg caffeine group (AFA:-17.0 ± 31.4 v.s. 16.3 ± 34.1 cm(2); p hesperidin were enhanced dose-dependently by caffeine addition. BMI decreases were significantly greater in the G-hesperidin with 75-mg caffeine group than in the placebo group (-0.56 ± 0.74 v.s. -0.02 ± 0.58 kg/m(2); p hesperidin with/without caffeine had no effect on serum TG (p > 0.05 v.s. placebo). These data suggested that a combination of 500-mg G-hesperidin with 50- or 75-mg caffeine may be useful for the prevention or treatment of obesity. UMIN Clinical Trials Registry 000019241 .

  4. Arm rehabilitation in post stroke subjects: A randomized controlled trial on the efficacy of myoelectrically driven FES applied in a task-oriented approach.

    Science.gov (United States)

    Jonsdottir, Johanna; Thorsen, Rune; Aprile, Irene; Galeri, Silvia; Spannocchi, Giovanna; Beghi, Ettore; Bianchi, Elisa; Montesano, Angelo; Ferrarin, Maurizio

    2017-01-01

    Motor recovery of persons after stroke may be enhanced by a novel approach where residual muscle activity is facilitated by patient-controlled electrical muscle activation. Myoelectric activity from hemiparetic muscles is then used for continuous control of functional electrical stimulation (MeCFES) of same or synergic muscles to promote restoration of movements during task-oriented therapy (TOT). Use of MeCFES during TOT may help to obtain a larger functional and neurological recovery than otherwise possible. Multicenter randomized controlled trial. Eighty two acute and chronic stroke victims were recruited through the collaborating facilities and after signing an informed consent were randomized to receive either the experimental (MeCFES assisted TOT (M-TOT) or conventional rehabilitation care including TOT (C-TOT). Both groups received 45 minutes of rehabilitation over 25 sessions. Outcomes were Action Research Arm Test (ARAT), Upper Extremity Fugl-Meyer Assessment (FMA-UE) scores and Disability of the Arm Shoulder and Hand questionnaire. Sixty eight subjects completed the protocol (Mean age 66.2, range 36.5-88.7, onset months 12.7, range 0.8-19.1) of which 45 were seen at follow up 5 weeks later. There were significant improvements in both groups on ARAT (median improvement: MeCFES TOT group 3.0; C-TOT group 2.0) and FMA-UE (median improvement: M-TOT 4.5; C-TOT 3.5). Considering subacute subjects (time since stroke < 6 months), there was a trend for a larger proportion of improved patients in the M-TOT group following rehabilitation (57.9%) than in the C-TOT group (33.2%) (difference in proportion improved 24.7%; 95% CI -4.0; 48.6), though the study did not meet the planned sample size. This is the first large multicentre RCT to compare MeCFES assisted TOT with conventional care TOT for the upper extremity. No adverse events or negative outcomes were encountered, thus we conclude that MeCFES can be a safe adjunct to rehabilitation that could promote recovery of

  5. Arm rehabilitation in post stroke subjects: A randomized controlled trial on the efficacy of myoelectrically driven FES applied in a task-oriented approach.

    Directory of Open Access Journals (Sweden)

    Johanna Jonsdottir

    Full Text Available Motor recovery of persons after stroke may be enhanced by a novel approach where residual muscle activity is facilitated by patient-controlled electrical muscle activation. Myoelectric activity from hemiparetic muscles is then used for continuous control of functional electrical stimulation (MeCFES of same or synergic muscles to promote restoration of movements during task-oriented therapy (TOT. Use of MeCFES during TOT may help to obtain a larger functional and neurological recovery than otherwise possible.Multicenter randomized controlled trial.Eighty two acute and chronic stroke victims were recruited through the collaborating facilities and after signing an informed consent were randomized to receive either the experimental (MeCFES assisted TOT (M-TOT or conventional rehabilitation care including TOT (C-TOT. Both groups received 45 minutes of rehabilitation over 25 sessions. Outcomes were Action Research Arm Test (ARAT, Upper Extremity Fugl-Meyer Assessment (FMA-UE scores and Disability of the Arm Shoulder and Hand questionnaire.Sixty eight subjects completed the protocol (Mean age 66.2, range 36.5-88.7, onset months 12.7, range 0.8-19.1 of which 45 were seen at follow up 5 weeks later. There were significant improvements in both groups on ARAT (median improvement: MeCFES TOT group 3.0; C-TOT group 2.0 and FMA-UE (median improvement: M-TOT 4.5; C-TOT 3.5. Considering subacute subjects (time since stroke < 6 months, there was a trend for a larger proportion of improved patients in the M-TOT group following rehabilitation (57.9% than in the C-TOT group (33.2% (difference in proportion improved 24.7%; 95% CI -4.0; 48.6, though the study did not meet the planned sample size.This is the first large multicentre RCT to compare MeCFES assisted TOT with conventional care TOT for the upper extremity. No adverse events or negative outcomes were encountered, thus we conclude that MeCFES can be a safe adjunct to rehabilitation that could promote recovery

  6. Resveratrol does not influence metabolic risk markers related to cardiovascular health in overweight and slightly obese subjects: a randomized, placebo-controlled crossover trial.

    Directory of Open Access Journals (Sweden)

    Sanne M van der Made

    Full Text Available In vitro and animal studies have shown positive effects of resveratrol on lipid and lipoprotein metabolism, but human studies specifically designed to examine these effects are lacking.The primary outcome parameter of this study in overweight and slightly obese subjects was the effect of resveratrol on apoA-I concentrations. Secondary outcome parameters were effects on other markers of lipid and lipoprotein metabolism, glucose metabolism, and markers for inflammation and endothelial function.This randomized, placebo-controlled crossover study was conducted in 45 overweight and slightly obese men (n = 25 and women (n = 20 with a mean age of 61 ± 7 years. Subjects received in random order resveratrol (150 mg per day or placebo capsules for 4 weeks, separated by a 4-week wash-out period. Fasting blood samples were collected at baseline and at the end of each intervention period.Compliance was excellent as indicated by capsule count and changes in resveratrol and dihydroresveratrol concentrations. No difference between resveratrol and placebo was found in any of the fasting serum or plasma metabolic risk markers (mean ± SD for differences between day 28 values of resveratrol vs. placebo: apoA-I; 0.00 ± 0.12 g/L (P = 0.791, apoB100; -0.01 ± 0.11 g/L (P = 0.545, HDL cholesterol; 0.00 ± 0.09 mmol/L (P = 0.721, LDL cholesterol -0.03 ± 0.57 mmol/L (P = 0.718, triacylglycerol; 0.10 ± 0.54 mmol/L (P = 0.687, glucose; -0.08 ± 0.28 mmol/L (P = 0.064, insulin; -0.3 ± 2.5 mU/L (P = 0.516. Also, no effects on plasma markers for inflammation and endothelial function were observed. No adverse events related to resveratrol intake were observed.150 mg of daily resveratrol intake for 4 weeks does not change metabolic risk markers related to cardiovascular health in overweight and slightly obese men and women. Effects on glucose metabolism warrant further study.ClinicalTrials.gov NCT01364961.

  7. Effect of time of administration on cholesterol-lowering by psyllium: a randomized cross-over study in normocholesterolemic or slightly hypercholesterolemic subjects

    Directory of Open Access Journals (Sweden)

    Edwards Alun L

    2004-09-01

    Full Text Available Abstract Background Reports of the use of psyllium, largely in hypercholesterolemic men, have suggested that it lowers serum cholesterol as a result of the binding of bile acids in the intestinal lumen. Widespread advertisements have claimed an association between the use of soluble fibre from psyllium seed husk and a reduced risk of coronary heart disease. Given the purported mechanism of cholesterol-lowering by psyllium, we hypothesized that there would be a greater effect when psyllium is taken with breakfast than when taken at bedtime. Secondarily, we expected to confirm a cholesterol-lowering effect of psyllium in subjects with "average" cholesterol levels. Methods Sixteen men and 47 women ranging in age from 18 to 77 years [mean 53 +/- 13] with LDL cholesterol levels that were normal or slightly elevated but acceptable for subjects at low risk of coronary artery disease were recruited from general gastroenterology and low risk lipid clinics. Following a one month dietary stabilization period, they received an average daily dose of 12.7 g of psyllium hydrophilic mucilloid, in randomized order, for 8 weeks in the morning and 8 weeks in the evening. Change from baseline was determined for serum total cholesterol, LDL, HDL and triglycerides. Results Total cholesterol for the "AM first" group at baseline, 8 and 16 weeks was 5.76, 5.77 and 5.80 mmol/L and for the "PM first" group the corresponding values were 5.47, 5.61 and 5.57 mmol/L. No effect on any lipid parameter was demonstrated for the group as a whole or in any sub-group analysis. Conclusion The timing of psyllium administration had no effect on cholesterol-lowering and, in fact, no cholesterol-lowering was observed. Conclusions regarding the effectiveness of psyllium for the prevention of heart disease in the population at large may be premature.

  8. Low-dose ticagrelor yields an antiplatelet efficacy similar to that of standard-dose ticagrelor in healthy subjects: an open-label randomized controlled trial.

    Science.gov (United States)

    Li, Pan; Gu, Ying; Yang, Yawei; Chen, Lizhi; Liu, Junmei; Gao, Lihong; Qin, Yongwen; Cai, Quancai; Zhao, Xianxian; Wang, Zhuo; Ma, Liping

    2016-08-24

    Ticagrelor has a greater antiplatelet efficacy than clopidogrel but may be accompanied by an increased risk of bleeding. This study evaluated the antiplatelet effect and pharmacokinetic profile of low-dose ticagrelor in healthy Chinese volunteers. Thirty healthy subjects were randomized to receive standard-dose ticagrelor (180-mg loading dose, 90-mg twice daily [bid] [n = 10]), low-dose ticagrelor (90-mg loading dose, 45-mg bid [n = 10]), or clopidogrel (600-mg loading dose, 75-mg once daily [n = 10]). Platelet reactivity was assessed by using the VerifyNow P2Y12 assay at baseline and 0.5, 1, 2, 4, 8, 24, 48, and 72 hours post-dosing. The ticagrelor and AR-C124910XX concentrations were measured for pharmacokinetic analysis. The percentage inhibition of P2Y12 reaction units was higher in the low-dose and standard-dose ticagrelor group than in the clopidogrel group at 0.5, 1, 2, 4, 8, and 48 hours post-dosing (P ticagrelor doses at any time-point (P > 0.05). The plasma ticagrelor and ARC124910XX concentrations were approximately 2-fold higher with standard-dose versus low-dose ticagrelor. No serious adverse events were reported. In conclusion, low-dose ticagrelor achieved faster and higher inhibition of platelet functions in healthy Chinese subjects than did clopidogrel, with an antiplatelet efficacy similar to that of standard-dose ticagrelor.

  9. Immediate effect of ultrasound and ischemic compression techniques for the treatment of trapezius latent myofascial trigger points in healthy subjects: a randomized controlled study.

    Science.gov (United States)

    Aguilera, F Javier Montañez; Martín, Daniel Pecos; Masanet, Rosana Arnau; Botella, Ana Camps; Soler, Lorena Borja; Morell, Francisco Bosch

    2009-09-01

    The purpose of this study was to determine immediate effects of ischemic compression (IC) and ultrasound (US) for the treatment of myofascial trigger points (MTrPs) in the trapezius muscle. Sixty-six volunteers, all CEU-Cardenal Herrera University, Valencia, Spain, personnel, participated in this study. Subjects were healthy individuals, diagnosed with latent MTrPs in the trapezius muscle. Subjects were randomly placed into 3 groups: G1, which received IC treatment for MTrPs; G2, which received US; and G3 (control), which received sham US. The following data were recorded before and after each treatment: active range of motion (AROM) of cervical rachis measured with a cervical range of motion instrument, basal electrical activity (BEA) of muscle trapezius measured with surface electromyography, and pressure tolerance of MTrP measured with visual analogue scale assessing local pain evoked by the application of 2.5 kg/cm(2) of pressure using a pressure analog algometer. The results showed an immediate decrease in BEA of the trapezius muscle and a reduction of MTrP sensitivity after treatment with both therapeutic modalities. In the case of IC, an improvement of AROM of cervical rachis was also been obtained. In this group of participants, both treatments were shown to have an immediate effect on latent MTrPs. The results show a relation among AROM of cervical rachis, BEA of the trapezius muscle, and MTrP sensitivity of the trapezius muscle gaining short-term positive effects with use of IC.

  10. Bioavailability of fatty acids from krill oil, krill meal and fish oil in healthy subjects--a randomized, single-dose, cross-over trial.

    Science.gov (United States)

    Köhler, Anton; Sarkkinen, Essi; Tapola, Niina; Niskanen, Tarja; Bruheim, Inge

    2015-03-15

    Krill contains two marine omega-3 polyunsaturated fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), mainly bound in phospholipids. Typical products from krill are krill oil and krill meal. Fish oils contain EPA and DHA predominantly bound in triglycerides. The difference in the chemical binding of EPA and DHA has been suggested to affect their bioavailability, but little is known on bioavailability of EPA and DHA in krill meal. This study was undertaken to compare the acute bioavailability of two krill products, krill oil and krill meal, with fish oil in healthy subjects. A randomized, single-dose, single-blind, cross-over, active-reference trial was conducted in 15 subjects, who ingested krill oil, krill meal and fish oil, each containing approx. 1 700 mg EPA and DHA. Fatty acid compositions of plasma triglycerides and phospholipids were measured repeatedly for 72 hours. The primary efficacy analysis was based on the 72 hour incremental area under the curve (iAUC) of EPA and DHA in plasma phospholipid fatty acids. A larger iAUC for EPA and DHA in plasma phospholipid fatty acids was detected after krill oil (mean 89.08±33.36%×h) than after krill meal (mean 44.97±18.07%xh, poil (mean 59.15±22.22%×h, p=0.003). Mean iAUC's after krill meal and after fish oil were not different. A large inter-individual variability in response was observed. EPA and DHA in krill oil had a higher 72-hour bioavailability than in krill meal or fish oil. Our finding that bioavailabilities of EPA and DHA in krill meal and fish oil were not different argues against the interpretation that phospholipids are better absorbed than triglycerides. Longer-term studies using a parameter reflecting tissue fatty acid composition, like erythrocyte EPA plus DHA are needed. NCT02089165.

  11. A randomized, single-blind, single-dose study evaluating the pharmacokinetic equivalence of proposed biosimilar ABP 980 and trastuzumab in healthy male subjects.

    Science.gov (United States)

    Hanes, Vladimir; Chow, Vincent; Zhang, Nan; Markus, Richard

    2017-05-01

    This study compared the pharmacokinetic (PK) profiles of the proposed biosimilar ABP 980 and trastuzumab in healthy males. In this single-blind study, 157 healthy males were randomized 1:1:1 to a single 6 mg/kg intravenous infusion of ABP 980, FDA-licensed trastuzumab [trastuzumab (US)], or EU-authorized trastuzumab [trastuzumab (EU)]. Primary endpoints were area under the serum concentration-time curve from time 0 to infinity (AUCinf) and maximum observed serum concentration (C max). To establish equivalence, the geometric mean ratio (GMR) and 90% confidence interval (CI) for C max and AUCinf had to be within the equivalence criteria of 0.80-1.25. The GMRs and 90% CIs for C max and AUCinf, respectively, were: 1.04 (0.99-1.08) and 1.06 (1.00-1.12) for ABP 980 versus trastuzumab (US); 0.99 (0.95-1.03) and 1.00 (0.95-1.06) for ABP 980 versus trastuzumab (EU); and 0.96 (0.92-1.00) and 0.95 (0.90-1.01) for trastuzumab (US) versus trastuzumab (EU). All comparisons were within the equivalence criteria of 0.80-1.25. Treatment-emergent adverse events (TEAEs) were reported in 84.0, 75.0, and 78.2 of subjects in the ABP 980, trastuzumab (US), and trastuzumab (EU) groups, respectively. There were no deaths or TEAEs leading to study discontinuation and no binding or neutralizing anti-drug anti-bodies were detected. This study demonstrated the PK similarity of ABP 980 to both trastuzumab (US) and trastuzumab (EU), and of trastuzumab (US) to trastuzumab (EU). No differences in safety and tolerability between treatments were noted; no subject tested positive for binding anti-bodies.

  12. Prevention of overuse injuries by a concurrent exercise program in subjects exposed to an increase in training load: a randomized controlled trial of 1020 army recruits.

    Science.gov (United States)

    Brushøj, Christoffer; Larsen, Klaus; Albrecht-Beste, Elisabeth; Nielsen, Michael Bachmann; Løye, Finn; Hölmich, Per

    2008-04-01

    It is unknown whether an exercise program can prevent overuse injuries in the lower extremity. An often encountered and important risk factor for the development of lower extremity overuse injuries is an abrupt increase in activity level. A preventive training program based on a literature review of intrinsic risk factors, and performed concurrent with an increase in physical activity, can reduce the incidence of overuse knee injuries and medial tibial stress syndrome, as well as increase running distance. Randomized controlled trial; Level of evidence, 1. A total of 1020 soldiers aged 20.9 years (range, 19-26 years) undergoing 3 months of basic military training consecutively enrolled from December 2004 to December 2005. The prevention program consisted of an exercise program of 15 minutes' duration 3 times a week, including 5 exercises for strength, flexibility, and coordination; the placebo program consisted of 5 exercises for the upper body. During the observation period, 223 subjects sustained an injury, with 50 and 48 of these fulfilling the study criteria for overuse knee injuries or medial tibial stress syndrome, respectively. There were no significant differences in incidence of injury between the prevention group and the placebo group (incidence, 0.22 vs 0.19; P = .162; relative risk = 1.05 [range, 0.98-1.11]). The soldiers in the prevention group had the greater improvement in running distance in 12-minute run tests (82 vs 43 m; P = .037). An exercise program with an emphasis on muscular strengthening, coordination, and flexibility based on intrinsic risk factors identified through a literature review did not influence the risk of developing overuse knee injuries or medial tibial stress syndrome in subjects undergoing an increase in physical activity. The program increased maximal running distance in a 12-minute test.

  13. Pediatric Online Evidence-Based Medicine Assignment Is a Novel Effective Enjoyable Undergraduate Medical Teaching Tool

    Science.gov (United States)

    Kotb, Magd A.; Elmahdy, Hesham Nabeh; Khalifa, Nour El Deen Mahmoud; El-Deen, Mohamed Hamed Nasr; Lotfi, Mohamed Amr N.

    2015-01-01

    Abstract Evidence-based medicine (EBM) is delivered through a didactic, blended learning, and mixed models. Students are supposed to construct an answerable question in PICO (patient, intervention, comparison, and outcome) framework, acquire evidence through search of literature, appraise evidence, apply it to the clinical case scenario, and assess the evidence in relation to clinical context. Yet these teaching models have limitations especially those related to group work, for example, handling uncooperative students, students who fail to contribute, students who domineer, students who have personal conflict, their impact upon progress of their groups, and inconsistent individual acquisition of required skills. At Pediatrics Department, Faculty of Medicine, Cairo University, we designed a novel undergraduate pediatric EBM assignment online system to overcome shortcomings of previous didactic method and aimed to assess its effectiveness by prospective follow-up during academic years 2012 to 2013 and 2013 to 2014. The novel web-based online interactive system was tailored to provide sequential single and group assignments for each student. Single assignment addressed a specific case scenario question, while group assignment was teamwork that addressed different questions of same case scenario. Assignment comprised scholar content and skills. We objectively analyzed students’ performance by criterion-based assessment and subjectively by anonymous student questionnaire. A total of 2879 were enrolled in 5th year Pediatrics Course consecutively, of them 2779 (96.5%) logged in and 2554 (88.7%) submitted their work. They were randomly assigned to 292 groups. A total of 2277 (89.15%) achieved ≥80% of total mark (4/5), of them 717 (28.1%) achieved a full mark. A total of 2178 (85.27%) and 2359 (92.36%) made evidence-based conclusions and recommendations in single and group assignment, respectively (P < 0.001). A total of 1102 (43.1%) answered student questionnaire

  14. White Grape Juice Elicits a Lower Breath Hydrogen Response Compared with Apple Juice in Healthy Human Subjects: A Randomized Controlled Trial.

    Science.gov (United States)

    Erickson, Jennifer; Wang, Qi; Slavin, Joanne

    2017-06-01

    Diets low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPS) are used to manage symptoms in individuals with irritable bowel syndrome. Although effective at reducing symptoms, the diet can be complex and restrictive. In addition, there are still large gaps in the literature and many foods with unclear effects in the gastrointestinal (GI) tract, like fruit juice. Although many fruits are allowable on a low-FODMAP diet, consumption of all fruit juice is generally cautioned due to the large fructose load contained in juice, regardless of the glucose concentration. Very little research exists regarding the importance of limiting fructose load during a low-FODMAP diet; therefore, individuals following a low-FODMAP diet may be unnecessarily restricting their diets. To determine whether there is a difference in GI tolerance between juice from a high-FODMAP fruit (apple juice) and juice from a low-FODMAP fruit (white grape juice) in healthy human subjects. The goal is to provide insight into the role of juice in a low-FODMAP diet. A double-blind, randomized, controlled crossover study was conducted with 40 healthy adults. Fasted subjects consumed 12 oz of either apple juice or white grape juice. Breath hydrogen measures were taken at baseline, 1, 2, and 3 hours. Subjective GI tolerance surveys were completed at the same time intervals and at 12 and 24 hours. Breath hydrogen and GI symptoms were assessed with area under the curve analysis. Significance was determined with a two-sided t test with a P value hydrogen area under the curve at 23.3 ppm/hour (95% CI 13.0 to 33.6) compared with white grape juice at 5.8 ppm/hour (95% CI -4.6 to 16.1) (Phydrogen, which may suggest excluding foods only because of the high fructose load could be unnecessarily restrictive. The results of this study suggest that the fructose-to-glucose ratio is likely more important than the total fructose load of the food when considering the acceptability of a food

  15. In a randomized trial, the live attenuated tetravalent dengue vaccine TV003 is well-tolerated and highly immunogenic in subjects with flavivirus exposure prior to vaccination

    Science.gov (United States)

    Whitehead, Stephen S.; Durbin, Anna P.; Pierce, Kristen K.; Elwood, Dan; McElvany, Benjamin D.; Fraser, Ellen A.; Carmolli, Marya P.; Tibery, Cecilia M.; Hynes, Noreen A.; Jo, Matthew; Lovchik, Janece M.; Larsson, Catherine J.; Doty, Elena A.; Dickson, Dorothy M.; Luke, Catherine J.; Subbarao, Kanta; Kirkpatrick, Beth D.

    2017-01-01

    Infection caused by the four serotypes of dengue virus (DENV-1-4) is a leading cause of mosquito-borne disease. Clinically-severe dengue disease is more common when secondary dengue infection occurs following prior infection with a heterologous dengue serotype. Other flaviviruses such as yellow fever virus, Japanese encephalitis virus, and Zika virus, can also elicit antibodies which are cross-reactive to DENV. As candidate dengue vaccines become available in endemic settings and for individuals who have received other flavivirus vaccines, it is important to examine vaccine safety and immunogenicity in these flavivirus-experienced populations. We performed a randomized, controlled trial of the National Institutes of Health live attenuated tetravalent dengue vaccine candidate (TV003) in fifty-eight individuals with prior exposure to flavivirus infection or vaccine. As in prior studies of this vaccine in flavivirus-naive volunteers, flavivirus-experienced subjects received two doses of vaccine six months apart and were followed closely for clinical events, laboratory changes, viremia, and neutralizing antibody titers. TV003 was well tolerated with few adverse events other than rash, which was predominately mild. Following one dose, 87% of vaccinees had an antibody response to all four serotypes (tetravalent response), suggesting a robust immune response. In addition, 76% of vaccinees were viremic; mean peak titers ranged from 0.68–1.1 log10 PFU/mL and did not differ by serotype. The second dose of TV003 was not associated with viremia, rash, or a sustained boost in antibody titers indicating that a single dose of the vaccine is likely sufficient to prevent viral replication and thus protect against disease. In comparison to the viremia and neutralizing antibody response elicited by TV003 in flavivirus-naïve subjects from prior studies, we found that subjects who were flavivirus-exposed prior to vaccination exhibited slightly higher DENV-3 viremia, higher

  16. Twelve-week physical and leisure activity programme improved cognitive function in community-dwelling elderly subjects: a randomized controlled trial.

    Science.gov (United States)

    Kamegaya, Tadahiko; Araki, Yumi; Kigure, Hanami; Yamaguchi, Haruyasu

    2014-03-01

    Japan is one of the most rapidly ageing societies in the world. A number of municipalities have started services for the prevention of cognitive decline for community-dwelling elderly individuals, but the effectiveness of these services is currently insufficient. Our study explored the efficacy of a comprehensive intervention programme consisting of physical and leisure activities to prevent cognitive decline in community-dwelling elderly subjects. We administered a 12-week intervention programme consisting of physical and leisure activities aimed at enhancing participants' motivation to participate and support one another by providing a pleasant atmosphere, empathetic communication, praise, and errorless support. This programme for the prevention of cognitive decline was conducted as a service by the city of Maebashi. All participants underwent the Five-Cog test, which evaluated the cognitive domains of attention, memory, visuospatial function, language, and reasoning. Executive function was evaluated by the Wechsler Digit Symbol Substitution Test and Yamaguchi Kanji-Symbol Substitution Test. Subjective health status, level of social support, functional capacity, subjective quality of life, and depressive symptoms were assessed with a questionnaire. Grip strength test, timed up-and-go test, 5-m maximum walking times test, and functional reach test were performed to evaluate physical function. Fifty-two participants were randomly allocated to intervention (n = 26) and control (n = 26) groups. Twenty-six participants, aged between 65-87 years, received intervention once a week at a community centre. The programme was conducted by health-care professionals, with the help of senior citizen volunteers. The intervention group (n = 19) showed significant improvement on the analogy task of the Five-Cog test (F(1,38) = 4.242, P = 0.046) and improved quality of life (F(1,38) = 4.773, P = 0.035) as compared to the control group (n = 24). A community-based 12-week

  17. Regular consumption of vitamin D-fortified yogurt drink (Doogh improved endothelial biomarkers in subjects with type 2 diabetes: a randomized double-blind clinical trial

    Directory of Open Access Journals (Sweden)

    Shab-Bidar Sakineh

    2011-11-01

    Full Text Available Abstract Background Endothelial dysfunction has been proposed as the underlying cause of diabetic angiopathy that eventually leads to cardiovascular disease, the major cause of death in diabetes. We recently demonstrated the ameliorating effect of regular vitamin D intake on the glycemic status of patients with type 2 diabetes (T2D. In this study, the effects of improvement of vitamin D status on glycemic status, lipid profile and endothelial biomarkers in T2D subjects were investigated. Methods Subjects with T2D were randomly allocated to one of the two groups to receive either plain yogurt drink (PYD; containing 170 mg calcium and no vitamin D/250 mL, n1 = 50 or vitamin D3-fortified yogurt drink (FYD; containing 170 mg calcium and 500 IU/250 mL, n2 = 50 twice a day for 12 weeks. Anthropometric measures, glycemic status, lipid profile, body fat mass (FM and endothelial biomarkers including serum endothelin-1, E-selectin and matrix metalloproteinase (MMP-9 were evaluated at the beginning and after the 12-week intervention period. Results The intervention resulted in a significant improvement in fasting glucose, the Quantitative Insulin Check Index (QUICKI, glycated hemoglobin (HbA1c, triacylglycerols, high-density lipoprotein cholesterol (HDL-C, endothelin-1, E-selectin and MMP-9 in FYD compared to PYD (P P = 0.028; -3.8 ± 7.3 versus 0.95 ± 8.3, P = 0.003 and -2.3 ± 3.7 versus 0.44 ± 7.1 ng/mL, respectively, P P = 0.009 and P = 0.005, respectively but disappeared for E-selectin (P = 0.092. On the contrary, after controlling for serum 25(OHD, the differences disappeared for endothelin-1(P = 0.066 and MMP-9 (P = 0.277 but still remained significant for E-selectin (P = 0.011. Conclusions Ameliorated vitamin D status was accompanied by improved glycemic status, lipid profile and endothelial biomarkers in T2D subjects. Our findings suggest both direct and indirect ameliorating effects of vitamin D on the endothelial biomarkers. Trial registration

  18. Regular consumption of vitamin D-fortified yogurt drink (Doogh) improved endothelial biomarkers in subjects with type 2 diabetes: a randomized double-blind clinical trial.

    Science.gov (United States)

    Shab-Bidar, Sakineh; Neyestani, Tirang R; Djazayery, Abolghassem; Eshraghian, Mohammad-Reza; Houshiarrad, Anahita; Gharavi, A'azam; Kalayi, Ali; Shariatzadeh, Nastaran; Zahedirad, Malihe; Khalaji, Niloufar; Haidari, Homa

    2011-11-24

    Endothelial dysfunction has been proposed as the underlying cause of diabetic angiopathy that eventually leads to cardiovascular disease, the major cause of death in diabetes. We recently demonstrated the ameliorating effect of regular vitamin D intake on the glycemic status of patients with type 2 diabetes (T2D). In this study, the effects of improvement of vitamin D status on glycemic status, lipid profile and endothelial biomarkers in T2D subjects were investigated. Subjects with T2D were randomly allocated to one of the two groups to receive either plain yogurt drink (PYD; containing 170 mg calcium and no vitamin D/250 mL, n1 = 50) or vitamin D3-fortified yogurt drink (FYD; containing 170 mg calcium and 500 IU/250 mL, n2 = 50) twice a day for 12 weeks. Anthropometric measures, glycemic status, lipid profile, body fat mass (FM) and endothelial biomarkers including serum endothelin-1, E-selectin and matrix metalloproteinase (MMP)-9 were evaluated at the beginning and after the 12-week intervention period. The intervention resulted in a significant improvement in fasting glucose, the Quantitative Insulin Check Index (QUICKI), glycated hemoglobin (HbA1c), triacylglycerols, high-density lipoprotein cholesterol (HDL-C), endothelin-1, E-selectin and MMP-9 in FYD compared to PYD (P < 0.05, for all). Interestingly, difference in changes of endothelin-1, E-selectin and MMP-9 concentrations in FYD compared to PYD (-0.35 ± 0.63 versus -0.03 ± 0.55, P = 0.028; -3.8 ± 7.3 versus 0.95 ± 8.3, P = 0.003 and -2.3 ± 3.7 versus 0.44 ± 7.1 ng/mL, respectively, P < 0.05 for all), even after controlling for changes of QUICKI, FM and waist circumference, remained significant for endothelin-1 and MMP-9 (P = 0.009 and P = 0.005, respectively) but disappeared for E-selectin (P = 0.092). On the contrary, after controlling for serum 25(OH)D, the differences disappeared for endothelin-1(P = 0.066) and MMP-9 (P = 0.277) but still remained significant for E-selectin (P = 0

  19. Concentration-QT analysis of the randomized, placebo- and moxifloxacin-controlled thorough QT study of umeclidinium monotherapy and umeclidinium/vilanterol combination in healthy subjects.

    Science.gov (United States)

    Mehta, Rashmi; Green, Michelle; Patel, Bela; Wagg, Jonathan

    2016-04-01

    The long-acting muscarinic antagonist umeclidinium (UMEC) is approved as a once-daily monotherapy and in combination with the long-acting β2 agonist vilanterol (VI) for chronic obstructive pulmonary disease. The objective of this analysis was to assess the relationship between observed plasma UMEC and/or VI concentrations and QT interval corrected using Fridericia's correction (QTcF). 103 subjects were enrolled and 86 (83 %) completed the study. Subjects were randomized to 4 of 5 repeat-dose treatments (days 1-10: n = 77 subjects received placebo, n = 76 UMEC 500 µg, n = 78 UMEC/VI 125/25 µg, or n = 76 UMEC/VI 500/100 µg; day 10: n = 74 oral tablet moxifloxacin 400 mg [positive control]). The concentration-QTcF interval relationship was examined using nonlinear mixed-effects methods. For UMEC, predicted QTcF interval prolongation (at observed geometric mean of maximum plasma concentrations) was -2.38 ms (90 % prediction interval [PI] -3.82, -0.85) with UMEC 500 µg and -0.50 ms (90 % PI -0.80, -0.18) and -2.01 ms (90 % PI -3.22, -0.72) with UMEC/VI 125/25 µg and 500/100 µg, respectively. For VI, estimates were 5.89 ms (90 % PI 4.89, 6.91) and 7.23 ms (90 % PI 5.88, 8.55) with UMEC/VI 125/25 µg and 500/100 µg, respectively. Combined additive mean effects were estimated for UMEC/VI 125/25 µg (5.39 ms [90 % PI 4.40, 6.47]) and 500/100 µg (5.22 ms [90 % PI 3.72, 6.80]). The model-predicted decrease with UMEC and increase with UMEC/VI combination in QTcF interval suggest that the QT effect is likely attributable to VI. These model-predicted results support those of previously-published traditional statistical analyses.

  20. Repetitive Intermittent Hypoxia and Locomotor Training Enhances Walking Function in Incomplete Spinal Cord Injury Subjects: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    Navarrete-Opazo, Angela; Alcayaga, Julio; Sepúlveda, Oscar; Rojas, Enrique; Astudillo, Carolina

    2017-05-01

    Incomplete spinal cord injuries (iSCI) leave spared synaptic pathways below the level of injury. Intermittent hypoxia (IH) elicits plasticity in the spinal cord and strengthens spared synaptic pathways, expressed as respiratory and somatic functional recovery in experimental animals and humans with iSCI. This study is a randomized, triple-blind, two-arm parallel clinical trial performed in Santiago, Chile. We compared the effects of a 4-week protocol of IH combined with body weight-supported treadmill training (BWSTT), with continuous normoxia (Nx) and BWSTT on 10-meter walk test (10MWT), 6-minute walk test (6MWT), and timed up and go (TUG) test in American Spinal Injury Association C and D individuals with iSCI. Subjects received daily IH (cycling 9%/21% O 2 every 1.5 min, 15 cycles/day) or continuous Nx (21% O 2 ) combined with 45 min BWSTT for 5 consecutive days, followed by IH/Nx 3 × per week (3 × wIH/Nx) for 3 additional weeks. Subjects were assessed at day 5, weekly from weeks 2-4, and at a 2-week follow-up. Daily IH plus BWSTT enhanced walking speed, expressed as decreased 10MWT time at day 5 versus baseline (IH: -10.2 ± 3.0 vs. Nx: -1.7 ± 1.7 sec, p = 0.006), and walking endurance expressed as increased 6MWT distance at day 5 versus baseline (IH: 43.0 ± 10.7 vs. Nx: 6.1 ± 3.4 m, p = 0.012), but not TUG time. Further, 3 × wIH maintained the daily IH-induced walking speed, and enhanced the daily IH-induced walking endurance, which is maintained up to the 2-week follow-up. We conclude that daily IH enhances walking recovery in subjects with iSCI, confirming previous findings. Moreover, 3 × wIH prolonged or enhanced daily IH-induced walking speed and endurance improvements, respectively, up to 5 weeks post-daily IH. Repetitive IH may be a safe and effective therapeutic alternative for persons with iSCI.

  1. Effects of a healthy Nordic diet on plasma 25-hydroxyvitamin D concentration in subjects with metabolic syndrome: a randomized, [corrected] controlled trial (SYSDIET).

    Science.gov (United States)

    Brader, Lea; Rejnmark, Lars; Carlberg, Carsten; Schwab, Ursula; Kolehmainen, Marjukka; Rosqvist, Fredrik; Cloetens, Lieselotte; Landin-Olsson, Mona; Gunnarsdottir, Ingibjorg; Poutanen, Kaisa S; Herzig, Karl-Heinz; Risérus, Ulf; Savolainen, Markku J; Thorsdottir, Inga; Uusitupa, Matti; Hermansen, Kjeld

    2014-06-01

    At northern latitudes, vitamin D is not synthesized endogenously during winter, causing low plasma 25-hydroxyvitamin D (25(OH)D) concentrations. Therefore, we evaluated the effects of a healthy Nordic diet based on Nordic nutrition recommendations (NNR) on plasma 25(OH)D and explored its dietary predictors. In a Nordic multi-centre trial, subjects (n = 213) with metabolic syndrome were randomized to a control or a healthy Nordic diet favouring fish (≥300 g/week, including ≥200 g/week fatty fish), whole-grain products, berries, fruits, vegetables, rapeseed oil and low-fat dairy products. Plasma 25(OH)D and parathyroid hormone were analysed before and after 18- to 24-week intervention. At baseline, 45 % had vitamin D inadequacy (hormone (P = 0.207) were not altered by the healthy Nordic diet. Predictors for 25(OH)D were intake of vitamin D, eicosapentaenoic acids (EPA), docosahexaenoic acids (DHA), vitamin D supplement, plasma EPA and plasma DHA. Nevertheless, only vitamin D intake and season predicted the 25(OH)D changes. Consuming a healthy Nordic diet based on NNR increased vitamin D intake but not plasma 25(OH)D concentration. The reason why fish consumption did not improve vitamin D status might be that many fish are farmed and might contain little vitamin D or that frying fish may result in vitamin D extraction. Additional ways to improve vitamin D status in Nordic countries may be needed.

  2. Auditory and visual 3D virtual reality therapy as a new treatment for chronic subjective tinnitus: Results of a randomized controlled trial.

    Science.gov (United States)

    Malinvaud, D; Londero, A; Niarra, R; Peignard, Ph; Warusfel, O; Viaud-Delmon, I; Chatellier, G; Bonfils, P

    2016-03-01

    Subjective tinnitus (ST) is a frequent audiologic condition that still requires effective treatment. This study aimed at evaluating two therapeutic approaches: Virtual Reality (VR) immersion in auditory and visual 3D environments and Cognitive Behaviour Therapy (CBT). This open, randomized and therapeutic equivalence trial used bilateral testing of VR versus CBT. Adult patients displaying unilateral or predominantly unilateral ST, and fulfilling inclusion criteria were included after giving their written informed consent. We measured the different therapeutic effect by comparing the mean scores of validated questionnaires and visual analog scales, pre and post protocol. Equivalence was established if both strategies did not differ for more than a predetermined limit. We used univariate and multivariate analysis adjusted on baseline values to assess treatment efficacy. In addition of this trial, purely exploratory comparison to a waiting list group (WL) was provided. Between August, 2009 and November, 2011, 148 of 162 screened patients were enrolled (VR n = 61, CBT n = 58, WL n = 29). These groups did not differ at baseline for demographic data. Three month after the end of the treatment, we didn't find any difference between VR and CBT groups either for tinnitus severity (p = 0.99) or tinnitus handicap (p = 0.36). VR appears to be at least as effective as CBT in unilateral ST patients. Copyright © 2016 Elsevier B.V. All rights reserved.

  3. Pharmacodynamic consequences of administration of VLA-4 antagonist CDP323 to multiple sclerosis subjects: a randomized, double-blind phase 1/2 study.

    Directory of Open Access Journals (Sweden)

    Christian Wolf

    Full Text Available Lymphocyte inhibition by antagonism of α4 integrins is a validated therapeutic approach for relapsing multiple sclerosis (RMS.Investigate the effect of CDP323, an oral α4-integrin inhibitor, on lymphocyte biomarkers in RMS.Seventy-one RMS subjects aged 18-65 years with Expanded Disability Status Scale scores ≤6.5 were randomized to 28-day treatment with CDP323 100 mg twice daily (bid, 500 mg bid, 1000 mg once daily (qd, 1000 mg bid, or placebo.Relative to placebo, all dosages of CDP323 significantly decreased the capacity of lymphocytes to bind vascular adhesion molecule-1 (VCAM-1 and the expression of α4-integrin on VCAM-1-binding cells. All but the 100-mg bid dosage significantly increased total lymphocytes and naive B cells, memory B cells, and T cells in peripheral blood compared with placebo, and the dose-response relationship was shown to be linear. Marked increases were also observed in natural killer cells and hematopoietic progenitor cells, but only with the 500-mg bid and 1000-mg bid dosages. There were no significant changes in monocytes. The number of samples for regulator and inflammatory T cells was too small to draw any definitive conclusions.CDP323 at daily doses of 1000 or 2000 mg induced significant increases in total lymphocyte count and suppressed VCAM-1 binding by reducing unbound very late antigen-4 expression on lymphocytes.ClinicalTrials.gov NCT00726648.

  4. Comparative bioavailability and pharmacokinetics of two oral formulations of flurbiprofen: a single-dose, randomized, open-label, two-period, crossover study in Pakistani subjects.

    Science.gov (United States)

    Qayyum, Aisha; Najmi, Muzammil Hasan; Abbas, Mateen

    2013-11-01

    Comparative bioavailability studies are conducted to establish the bioequivalence of generic formulation with that of branded reference formulation, providing confidence to clinicians to use these products interchangeably. This study was carried out to compare a locally manufactured formulation of flurbiprofen with that of a branded product. Twenty two healthy male adults received a single dose of flurbiprofen (100mg) either generic or branded product according to randomization scheme on each of 2 periods. Blood samples were collected and plasma flurbiprofen concentration was determined by a validated HPLC method. Pharmacokinetic parameters like AUC(0-t), AUC(0-oo), Cmax, Tmax, t½, Vd and clearance were determined. The 90% CI for the ratio of geometric means of test to reference product's pharmacokinetic variables was calculated. Pharmacokinetic parameters for two formulations were comparable. Ratio of means of AUC(0-24), AUC(0-oo) and Cmax for test to reference products and 90% CI for these ratios were within the acceptable range. The p-values calculated by TOST were much less than the specified value (p-0.05). ANOVA gave p-values which were more than the specified value (p-0.05) for sequence, subject, period and formulation. Test formulation of flurbiprofen (tablet Flurso) was found to meet the criteria for bioequivalence to branded product (tablet Ansaid) based on pharmacokinetic parameters.

  5. Effectiveness of Kinesio Taping for Hand on Grip Strength and Upper Limb Function in Subjects with Cervical Radiculopathy: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Shruti Prabhu

    2017-08-01

    Full Text Available Cervical radiculopathy is common condition seen today. It is found to associate with upper limb dysfunction which in turn hinders daily activity due to muscular weakness. Grip strength is found to be reduced in cervical radiculopathy and is taken to be a good measure of upper limb function. Treatment of cervical radiculopathy is mainly concentrated over neck region and very less has been done to improve upper limb function. Kinesio taping is found to improve muscle activity and can be used to improve grip strength and function in cervical radiculopathy. Method: 32 subjects with unilateral cervical radiculopathy were randomly divided into 2 groups, experimental and conventional group (n=16. The conventional group was given intermittent cervical traction, hot moist pack, TENS and exercises and experimental group was given conventional treatment along with kinesio taping to extensor aspect of forearm. Preand post-values for grip and pinch strength and NDI and DASH were assessed and analysed. Result: There was marked improvement seen both groups, but there was significant improvement in grip and pinch strength seen in experimental group while there was improvement seen functional outcomes namely NDI and DASH. This suggests that kinesio taping does not play a role in improving grip strength but can improve upper limb function.

  6. Effect of consumption of chicory inulin on bowel function in healthy subjects with constipation: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Micka, Antje; Siepelmeyer, Anne; Holz, Anja; Theis, Stephan; Schön, Christiane

    2017-02-01

    Constipation is among the most common health impairments in Western countries. This study aimed to determine the effect of the chicory-derived fermentable dietary fiber Orafti ® Inulin on stool frequency in healthy subjects with constipation. The study was conducted according to recent guidance documents for investigating bowel function and used a randomized, double-blind, placebo-controlled, cross-over design with a 2-week wash-out phase. Each study period comprised a run-in phase followed by 4 weeks daily intake of 3 × 4g inulin or maltodextrin (placebo). Forty-four healthy volunteers with constipation documented stool frequency and consistency, gastrointestinal characteristics and quality of life. Consumption of Orafti ® Inulin significantly increased stool frequency compared to placebo (median 4.0 [IQR 2.5-4.5] versus 3.0 [IQR 2.5-4.0] stools/week, p = 0.038). This was accompanied by a softening of stools and trend toward higher satisfaction versus placebo (p = 0.059). In conclusion, Orafti ® Inulin was effective in volunteers with chronic constipation and significantly improved bowel function. This trial was registered at clinicaltrials.gov as NCT02548247.

  7. Protein Side-Chain Resonance Assignment and NOE Assignment Using RDC-Defined Backbones without TOCSY Data3

    Science.gov (United States)

    Zeng, Jianyang; Zhou, Pei; Donald, Bruce Randall

    2011-01-01

    One bottleneck in NMR structure determination lies in the laborious and time-consuming process of side-chain resonance and NOE assignments. Compared to the well-studied backbone resonance assignment problem, automated side-chain resonance and NOE assignments are relatively less explored. Most NOE assignment algorithms require nearly complete side-chain resonance assignments from a series of through-bond experiments such as HCCH-TOCSY or HCCCONH. Unfortunately, these TOCSY experiments perform poorly on large proteins. To overcome this deficiency, we present a novel algorithm, called NASCA (NOE Assignment and Side-Chain Assignment), to automate both side-chain resonance and NOE assignments and to perform high-resolution protein structure determination in the absence of any explicit through-bond experiment to facilitate side-chain resonance assignment, such as HCCH-TOCSY. After casting the assignment problem into a Markov Random Field (MRF), NASCA extends and applies combinatorial protein design algorithms to compute optimal assignments that best interpret the NMR data. The MRF captures the contact map information of the protein derived from NOESY spectra, exploits the backbone structural information determined by RDCs, and considers all possible side-chain rotamers. The complexity of the combinatorial search is reduced by using a dead-end elimination (DEE) algorithm, which prunes side-chain resonance assignments that are provably not part of the optimal solution. Then an A* search algorithm is employed to find a set of optimal side-chain resonance assignments that best fit the NMR data. These side-chain resonance assignments are then used to resolve the NOE assignment ambiguity and compute high-resolution protein structures. Tests on five proteins show that NASCA assigns resonances for more than 90% of side-chain protons, and achieves about 80% correct assignments. The final structures computed using the NOE distance restraints assigned by NASCA have backbone RMSD 0

  8. The relationship between negative emotions and acute subjective and objective symptoms of childhood asthma.

    NARCIS (Netherlands)

    Rietveld, S.; Prins, P.J.M.

    1998-01-01

    Examined whether negative emotions influence subjective rather than objective symptoms of asthma, breathlessness, and airways obstruction in 40 asthmatic children (aged 7-18 yrs). The Ss were randomly assigned to 1 of 4 experimental conditions: (1) viewing an emotional film of 10 min; (2) performing

  9. Counting Blessings in Early Adolescents: An Experimental Study of Gratitude and Subjective Well-Being

    Science.gov (United States)

    Froh, Jeffery J.; Sefick, William J.; Emmons, Robert A.

    2008-01-01

    The development and manifestation of gratitude in youth is unclear. We examined the effects of a grateful outlook on subjective well-being and other outcomes of positive psychological functioning in 221 early adolescents. Eleven classes were randomly assigned to either a gratitude, hassles, or control condition. Results indicated that counting…

  10. Active learning in pre-class assignments: Exploring the use of interactive simulations to enhance reading assignments

    CERN Document Server

    Stang, Jared B; Perez, Sarah; Ives, Joss; Roll, Ido

    2016-01-01

    Pre-class reading assignments help prepare students for active classes by providing a first exposure to the terms and concepts to be used during class. We investigate if the use of inquiry-oriented PhET-based activities in conjunction with pre-class reading assignments can improve both the preparation of students for in-class learning and student attitudes towards and engagement with pre-class assignments. Over three course modules covering different topics, students were assigned randomly to complete either a textbook-only pre-class assignment or both a textbook pre-class assignment and a PhET-based activity. The assignments helped prepare students for class, as measured by performance on the pre-class quiz relative to a beginning-of-semester pre-test, but no evidence for increased learning due the PhET activity was observed. Students rated the assignments which included PhET as more enjoyable and, for the topic latest in the semester, reported engaging more with the assignments when PhET was included.

  11. Effects of Inspiratory and Expiratory Muscle Training in Normal Subjects

    OpenAIRE

    Sasaki, Makoto; Kurosawa, Hajime; Kohzuki, Masahiro

    2005-01-01

    The present study aimed to clarify the effects of inspiratory muscle training (IMT) and expiratory muscle training (EMT) on ventilatory muscle strength, pulmonary function and responses during exercise testing. Young healthy women were randomly assigned to 3 groups: IMT (n=16); EMT (n=16); or untrained normal controls (NC, n=8). Subjects in the IMT and EMT groups trained for 15 minutes twice daily over 2 weeks at loads of 30% maximal inspiratory and expiratory muscle strength, respectively. V...

  12. Alternative Assignment Incentive Pay Formats

    Science.gov (United States)

    2005-06-01

    300 dollars there was a 52% increase in applications and a 115 % increase in fill rates. This is extremely important to the Navy because it “suggest...Congress.” E-mail to Michael.T.Jones@navy.mil. 01 April 2005. 7. Nimon , W. R. and Hall, D. R. “An Experimental Analysis of the Relative Efficiency of...Scores (60 + 55 = 115 ). Accordingly, Bidder 1 is assigned to Job 1, Bidder 2 is unassigned, and Bidder 3 is assigned to Job 2. Payout in the

  13. A randomized, placebo- and moxifloxacin-controlled thorough QT study of umeclidinium monotherapy and umeclidinium/vilanterol combination in healthy subjects.

    Science.gov (United States)

    Kelleher, Dennis; Tombs, Lee; Preece, Andrew; Brealey, Noushin; Mehta, Rashmi

    2014-10-01

    The long-acting muscarinic antagonist umeclidinium (UMEC) and the combination of UMEC with the long-acting beta2 agonist vilanterol (VI) are approved maintenance treatments for chronic obstructive pulmonary disease in the US and EU. This study investigated the effect of UMEC and UMEC/VI on the QT interval corrected using Fridericia's correction (QTcF) following a 10-day treatment period. Randomized, placebo- and moxifloxacin-controlled, 4-period incomplete block crossover study of healthy non-smokers (n = 103). All treatments were double blind, except for moxifloxacin/moxifloxacin placebo controls which were single blinded. Subjects were randomized to a treatment sequence which consisted of 4 of 5 regimens. Each regimen consisted of once-daily doses on Days 1-10 via the ELLIPTA™ dry powder inhaler and a single tablet on Day 10 of the following: placebo + placebo; placebo + moxifloxacin; UMEC 500 μg + placebo; UMEC/VI 125/25 μg (delivered dose: 113/22 μg) + placebo; UMEC/VI 500/100 μg + placebo. QT interval, additional cardiac parameters, pharmacokinetics, pharmacodynamics and safety were assessed. No clinically significant changes from baseline in QTcF occurred with UMEC 500 μg and UMEC/VI 125/25 μg compared with placebo, however, there was a change in QTcF from baseline of 6.4 ms (90% confidence interval [CI]: 4.3, 8.5) at 10 min and 8.2 ms (90%: 6.2, 10.2) at 30 min post dose following UMEC/VI 500/100 μg compared with placebo. On Day 10, categorical analysis demonstrated absolute QTcF values >450-480 ms for UMEC/VI 125/25 μg (1 subject) and moxifloxacin (3 subjects), and a change from baseline QTcF of >30-60 ms for UMEC/VI 125/25 μg, UMEC 500/100 μg and placebo (1 subject each) and moxifloxacin (2 subjects). On Day 10, the mean change from baseline in heart rate was increased with UMEC/VI 125/25 μg and UMEC 500/100 μg compared with placebo with the maximum increase occurring at 10 min post dose (8.4 bpm [90% CI: 7.0, 9

  14. A Phase II, Randomized, Double-Blind, Placebo Controlled, Dose-Response Trial of the Melatonin Effect on the Pain Threshold of Healthy Subjects.

    Directory of Open Access Journals (Sweden)

    Luciana Cadore Stefani

    Full Text Available Previous studies have suggested that melatonin may produce antinociception through peripheral and central mechanisms. Based on the preliminary encouraging results of studies of the effects of melatonin on pain modulation, the important question has been raised of whether there is a dose relationship in humans of melatonin on pain modulation.The objective was to evaluate the analgesic dose response of the effects of melatonin on pressure and heat pain threshold and tolerance and the sedative effects.Sixty-one healthy subjects aged 19 to 47 y were randomized into one of four groups: placebo, 0.05 mg/kg sublingual melatonin, 0.15 mg/kg sublingual melatonin or 0.25 mg/kg sublingual melatonin. We determine the pressure pain threshold (PPT and the pressure pain tolerance (PPTo. Quantitative sensory testing (QST was used to measure the heat pain threshold (HPT and the heat pain tolerance (HPTo. Sedation was assessed with a visual analogue scale and bispectral analysis.Serum plasma melatonin levels were directly proportional to the melatonin doses given to each subject. We observed a significant effect associated with dose group. Post hoc analysis indicated significant differences between the placebo vs. the intermediate (0.15 mg/kg and the highest (0.25 mg/kg melatonin doses for all pain threshold and sedation level tests. A linear regression model indicated a significant association between the serum melatonin concentrations and changes in pain threshold and pain tolerance (R(2  = 0.492 for HPT, R(2  = 0.538 for PPT, R(2  = 0.558 for HPTo and R(2  = 0.584 for PPTo.The present data indicate that sublingual melatonin exerts well-defined dose-dependent antinociceptive activity. There is a correlation between the plasma melatonin drug concentration and acute changes in the pain threshold. These results provide additional support for the investigation of melatonin as an analgesic agent. Brazilian Clinical Trials Registry (ReBec: (U1111

  15. Rye-Based Evening Meals Favorably Affected Glucose Regulation and Appetite Variables at the Following Breakfast; A Randomized Controlled Study in Healthy Subjects.

    Directory of Open Access Journals (Sweden)

    Jonna C Sandberg

    Full Text Available Whole grain has shown potential to prevent obesity, cardiovascular disease and type 2 diabetes. Possible mechanism could be related to colonic fermentation of specific indigestible carbohydrates, i.e. dietary fiber (DF. The aim of this study was to investigate effects on cardiometabolic risk factors and appetite regulation the next day when ingesting rye kernel bread rich in DF as an evening meal.Whole grain rye kernel test bread (RKB or a white wheat flour based bread (reference product, WWB was provided as late evening meals to healthy young adults in a randomized cross-over design. The test products RKB and WWB were provided in two priming settings: as a single evening meal or as three consecutive evening meals prior to the experimental days. Test variables were measured in the morning, 10.5-13.5 hours after ingestion of RKB or WWB. The postprandial phase was analyzed for measures of glucose metabolism, inflammatory markers, appetite regulating hormones and short chain fatty acids (SCFA in blood, hydrogen excretion in breath and subjective appetite ratings.With the exception of serum CRP, no significant differences in test variables were observed depending on length of priming (P>0.05. The RKB evening meal increased plasma concentrations of PYY (0-120 min, P<0.001, GLP-1 (0-90 min, P<0.05 and fasting SCFA (acetate and butyrate, P<0.05, propionate, P = 0.05, compared to WWB. Moreover, RKB decreased blood glucose (0-120 min, P = 0.001, serum insulin response (0-120 min, P<0.05 and fasting FFA concentrations (P<0.05. Additionally, RKB improved subjective appetite ratings during the whole experimental period (P<0.05, and increased breath hydrogen excretion (P<0.001, indicating increased colonic fermentation activity.The results indicate that RKB evening meal has an anti-diabetic potential and that the increased release of satiety hormones and improvements of appetite sensation could be beneficial in preventing obesity. These effects could

  16. Adverse effects on insulin secretion of replacing saturated fat with refined carbohydrate but not with monounsaturated fat: A randomized controlled trial in centrally obese subjects.

    Science.gov (United States)

    Chang, Lin F; Vethakkan, Shireene R; Nesaretnam, Kalanithi; Sanders, Thomas A B; Teng, Kim-Tiu

    Current dietary guidelines recommend the replacement of saturated fatty acids (SAFAs) with carbohydrates or monounsaturated fatty acids (MUFAs) based on evidence on lipid profile alone, the chronic effects of the mentioned replacements on insulin secretion and insulin sensitivity are however unclear. To assess the chronic effects of the substitution of refined carbohydrate or MUFA for SAFA on insulin secretion and insulin sensitivity in centrally obese subjects. Using a crossover design, randomized controlled trial in abdominally overweight men and women, we compared the effects of substitution of 7% energy as carbohydrate or MUFA for SAFA for a period of 6 weeks each. Fasting and postprandial blood samples in response to corresponding SAFA, carbohydrate, or MUFA-enriched meal-challenges were collected after 6 weeks on each diet treatment for the assessment of outcomes. As expected, postprandial nonesterified fatty acid suppression and elevation of C-peptide, insulin and glucose secretion were the greatest with high-carbohydrate (CARB) meal. Interestingly, CARB meal attenuated postprandial insulin secretion corrected for glucose response; however, the insulin sensitivity and disposition index were not affected. SAFA and MUFA had similar effects on all markers except for fasting glucose-dependent insulinotropic peptide concentrations, which increased after MUFA but not SAFA when compared with CARB. In conclusion, a 6-week lower-fat/higher-carbohydrate (increased by 7% refined carbohydrate) diet may have greater adverse effect on insulin secretion corrected for glucose compared with isocaloric higher-fat diets. In contrast, exchanging MUFA for SAFA at 7% energy had no appreciable adverse impact on insulin secretion. Copyright © 2016 National Lipid Association. Published by Elsevier Inc. All rights reserved.

  17. Effects and cost of glycyrrhizin in the treatment of upper respiratory tract infections in members of the Japanese maritime self-defense force: Preliminary report of a prospective, randomized, double-blind, controlled, parallel-group, alternate-day treatment assignment clinical trial.

    Science.gov (United States)

    Yanagawa, Youichi; Ogura, Masatsune; Fujimoto, Eita; Shono, Satoshi; Okuda, Eriya

    2004-01-01

    Upper respiratory tract infections (URTIs) account for at least half of all acute illnesses. Specific antiviral therapy has not been developed against most respiratory viruses thought to cause URTIs. The pharmacologic action of glycyrrhizin has been shown to produce anti-inflammatory activity, modulation of the immune system, inhibition of virus growth, and inactivation of viruses. The aim of this study was to assess the tolerability, efficacy, and cost of glycyrrhizin in improving the severity and duration of signs and symptoms of URTIs. The primary end point was tolerability, and the secondary and points included improvement in signs and symptoms of URTI and cost. Members of the Japanese Maritime Self-Defense Force (SDF) treated for URTIs from January 2002 to May 2002 in the SDF Etajima Hospital (Hiroshima, Japan) were eligible for this prospective, randomized, double-blind, controlled, parallel-group, alternate-day treatment assignment study. All patients in this study fulfilled the following enrollment criteria: admitted to the hospital on the first arrival day as an outpatient; fever (body temperature women; mean [SD] age, 25.2 [1.5] years) were assigned to the glycyrrhizin group and 269 patients (24 men, 2 women; mean [SD] age, 22.6 [0.9] years) were assigned to the control group. The 2 groups were similar in terms of baseline characteristics. The mean duration of hospitalization was shorter (P = 0.01), the mean maximum body temperature 24 to 48 hours after admission was less (P = 0.05), and the cost of therapy (P = 0.03) was less in the glycyrrhizin group than the control group. No AEs were reported. In this study of hospitalized patients with URTIs, glycyrrhizin therapy was associated with a shorter hospitalization, lower-grade fever, and lower cost of therapy compared with controls, showing that it may be beneficial to patients with URTIs without acute bacterial infections.

  18. Fleet Assignment Using Collective Intelligence

    Science.gov (United States)

    Antoine, Nicolas E.; Bieniawski, Stefan R.; Kroo, Ilan M.; Wolpert, David H.

    2004-01-01

    Product distribution theory is a new collective intelligence-based framework for analyzing and controlling distributed systems. Its usefulness in distributed stochastic optimization is illustrated here through an airline fleet assignment problem. This problem involves the allocation of aircraft to a set of flights legs in order to meet passenger demand, while satisfying a variety of linear and non-linear constraints. Over the course of the day, the routing of each aircraft is determined in order to minimize the number of required flights for a given fleet. The associated flow continuity and aircraft count constraints have led researchers to focus on obtaining quasi-optimal solutions, especially at larger scales. In this paper, the authors propose the application of this new stochastic optimization algorithm to a non-linear objective cold start fleet assignment problem. Results show that the optimizer can successfully solve such highly-constrained problems (130 variables, 184 constraints).

  19. Who benefits from homework assignments?

    OpenAIRE

    Rønning, Marte

    2008-01-01

    Abstract: Using Dutch data on pupils in elementary school this paper is the first empirical study that analyzes whether assigning homework has an heterogeneous impact on pupil achievement. Addressing potential biases that arise from unobserved school quality, pupil selection by exploiting different methods, I find that the test score gap is larger in classes where everybody gets homework than in classes where nobody gets homework. More precisely pupils belonging to the upper part of the so...

  20. ESSENS dyslipidemia: A placebo-controlled, randomized study of a nutritional supplement containing red yeast rice in subjects with newly diagnosed dyslipidemia.

    Science.gov (United States)

    Kasliwal, Ravi R; Bansal, Manish; Gupta, Rajeev; Shah, Siddharth; Dani, Sameer; Oomman, Abraham; Pai, Vikas; Prasad, Guru Mallapa; Singhvi, Sunil; Patel, Jitendra; Sivam, Sakthivel; Trehan, Naresh

    2016-01-01

    Evidence suggests prolonged exposure to lower levels of low-density lipoprotein cholesterol (LDL-C), starting at a younger age, substantially lowers cardiovascular (CV) risk. Accordingly, the CV pandemic affecting younger population in low- to low-middle-income countries, where statin usage is poor even in secondary prevention, may benefit from lipid-lowering nutritional products, as nutritional intervention is generally preferred in these cultures. However, the safety and efficacy of such preparations have not been systematically tested. In this multicenter, double-blind study, 191 statin-free subjects with newly-diagnosed hyperlipidemia (LDL-C >120 mg/dL, 3.11 mmol/L) and no evidence of CV disease were randomized to one capsule of a proprietary bioactive phytonutrient formulation containing red yeast rice, grape-seed, niacinamide, and folic acid (RYR-NS) or matched placebo twice daily, along with lifestyle modification, for 12 wk. Mean baseline LDL-C levels were 148.5 ± 24.0 mg/dL (3.85 ± 0.62 mmol/L) and 148.6 ± 21.9 mg/dL (3.85 ± 0.57 mmol/L) in the RYR-NS and placebo groups respectively. Compared with placebo, RYR-NS resulted in a significant reduction in LDL-C (-29.4% versus -3.5%, P < 0.0001) and non-high-density lipoprotein cholesterol (non-HDL-C; -29.8% versus -10.3%, P < 0.0001) at 12 wk. With RYR-NS, 43.4% individuals attained desirable LDL-C levels and 55.4% desirable non-HDL-C levels by week 12, compared to only 0% and 1.1%, respectively, at baseline. No safety issues were observed. This study demonstrates the efficacy and safety of RYR-NS in lowering LDL-C and non-HDL-C after 12 wk, with magnitude of LDL-C reduction being comparable to that seen with moderate-intensity statin therapy. Further long-term studies are required to determine the impact of RYR-NS on treatment adherence and clinical outcomes. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  1. Efficacy of agomelatine and escitalopram on depression, subjective sleep and emotional experiences in patients with major depressive disorder: a 24-wk randomized, controlled, double-blind trial.

    Science.gov (United States)

    Corruble, Emmanuelle; de Bodinat, Christian; Belaïdi, Carole; Goodwin, Guy M

    2013-11-01

    In the present randomized, controlled, double-blind trial (12 wk treatment plus double-blind extension for 12 wk), 25-50 mg/d agomelatine (n = 164) and 10-20 mg/d escitalopram (n = 160) were compared for short- and long-term efficacy, subjective sleep and tolerability. The effects of these drugs on emotional experiences were also compared in patients having completed the Oxford Questionnaire on the Emotional Side-Effects of Antidepressants (agomelatine: n = 25; escitalopram: n = 20). Agomelatine and escitalopram similarly improved depressive symptoms, with clinically relevant score changes over 12 and 24 wk and notable percentage of remitters (week 12: 60.9 and 54.4%; week 24: 69.6 and 63.1% respectively). Over the 12 and 24-wk treatment periods, the 'global satisfaction on sleep' scores increased in both treatment groups and did not differ between groups. Satisfaction with sleep-wake quality was high in both groups; the 'wellness feeling on waking' was more improved with agomelatine than with escitalopram (p = 0.02). In patients with pronounced sleep complaints, quality of sleep and feeling on waking were significantly more improved with agomelatine than with escitalopram (p = 0.016 and p = 0.009, respectively). Emotional blunting was less frequent on agomelatine than on escitalopram. Indeed, 28% of patients on agomelatine vs. 60% on escitalopram felt that their emotions lacked intensity and 16% of patients on agomelatine vs. 53% on escitalopram felt that things that they cared about before illness did not seem important any more (p = 0.024). The tolerability profile of agomelatine was found to be superior to that of escitalopram and the incidence of patients with at least one emergent adverse event leading to treatment discontinuation was lower in the agomelatine group than in the escitalopram group (5.5 vs. 10.6%). The findings suggest that agomelatine displays additional long-term clinical benefits on sleep-wake quality and emotional experiences over

  2. Neural Mechanisms of Credit Assignment in a Multicue Environment

    Science.gov (United States)

    Kolling, Nils; Brown, Joshua W.; Rushworth, Matthew

    2016-01-01

    In complex environments, many potential cues can guide a decision or be assigned responsibility for the outcome of the decision. We know little, however, about how humans and animals select relevant information sources that should guide behavior. We show that subjects solve this relevance selection and credit assignment problem by selecting one cue and its association with a particular outcome as the main focus of a hypothesis. To do this, we examined learning while using a task design that allowed us to estimate the focus of each subject's hypotheses on a trial-by-trial basis. When a prediction is confirmed by the outcome, then credit for the outcome is assigned to that cue rather than an alternative. Activity in medial frontal cortex is associated with the assignment of credit to the cue that is the main focus of the hypothesis. However, when the outcome disconfirms a prediction, the focus shifts between cues, and the credit for the outcome is assigned to an alternative cue. This process of reselection for credit assignment to an alternative cue is associated with lateral orbitofrontal cortex. SIGNIFICANCE STATEMENT Learners should infer which features of environments are predictive of significant events, such as rewards. This “credit assignment” problem is particularly challenging when any of several cues might be predictive. We show that human subjects solve the credit assignment problem by implicitly “hypothesizing” which cue is relevant for predicting subsequent outcomes, and then credit is assigned according to this hypothesis. This process is associated with a distinctive pattern of activity in a part of medial frontal cortex. By contrast, when unexpected outcomes occur, hypotheses are redirected toward alternative cues, and this process is associated with activity in lateral orbitofrontal cortex. PMID:26818500

  3. Outpatient treatment of alcohol use disorders among subjects 60+ years

    DEFF Research Database (Denmark)

    Andersen, Kjeld; Bogenschutz, Michael P; Bühringer, Gerhard

    2015-01-01

    disorders (AUD). We present the rationale and design of a multisite, multinational AUD treatment study for subjects aged 60+ years. METHODS/DESIGN: 1,000 subjects seeking treatment for AUD according to DSM-5 in outpatient clinics in Denmark, Germany, and New Mexico (USA) are invited to participate in a RCT....... Participants are randomly assigned to four sessions of Motivational Enhancement Treatment (MET) or to MET plus an add-on with eight sessions based on the Community Reinforcement Approach (CRA), which include a new module targeting specific problems of older adults. A series of assessment instruments is applied...

  4. A Statistical Programme Assignment Model

    DEFF Research Database (Denmark)

    Rosholm, Michael; Staghøj, Jonas; Svarer, Michael

    When treatment effects of active labour market programmes are heterogeneous in an observable way  across the population, the allocation of the unemployed into different programmes becomes a particularly  important issue. In this paper, we present a statistical model designed to improve the present...... duration of unemployment spells may result if a statistical programme assignment model is introduced. We discuss several issues regarding the  plementation of such a system, especially the interplay between the statistical model and  case workers....

  5. An algorithm for ranking assignments using reoptimization

    DEFF Research Database (Denmark)

    Pedersen, Christian Roed; Nielsen, Lars Relund; Andersen, Kim Allan

    2008-01-01

    We consider the problem of ranking assignments according to cost in the classical linear assignment problem. An algorithm partitioning the set of possible assignments, as suggested by Murty, is presented where, for each partition, the optimal assignment is calculated using a new reoptimization...... technique. Computational results for the new algorithm are presented...

  6. Effect of fish oil supplementation on quality of life in a general population of older Dutch subjects: a randomized, double-blind, placebo-controlled trial.

    NARCIS (Netherlands)

    Rest, O. van de; Geleijnse, J.M.; Kok, F.J.; Staveren, W.A. van; Olde Rikkert, M.G.M.; Beekman, A.T.; Groot, L.C. de

    2009-01-01

    OBJECTIVES: To investigate the effect of eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA) supplementation on quality of life (QOL). DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Independently living individuals from the general older Dutch population. PARTICIPANTS:

  7. Effect of fish oil supplementation on quality of life in a general population of older Dutch subjects: a randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Rest, van de O.; Geleijnse, J.M.; Kok, F.; Staveren, van W.A.; Olderikkert, M.G.M.; Beekman, A.T.F.; Groot, de L.C.P.G.M.

    2009-01-01

    OBJECTIVES: To investigate the effect of eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA) supplementation on quality of life (QOL). DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Independently living individuals from the general older Dutch population. PARTICIPANTS:

  8. Yeast (1,3)-(1,6)-beta-glucan helps to maintain the body?s defence against pathogens: a double-blind, randomized, placebo-controlled, multicentric study in healthy subjects

    OpenAIRE

    Auinger, Annegret; Riede, Linda; Bothe, Gordana; Busch, Regina; Gruenwald, Joerg

    2013-01-01

    Purpose The effect of brewers? yeast (1,3)-(1,6)-beta-d-glucan consumption on the number of common cold episodes in healthy subject was investigated. Methods In a placebo-controlled, double-blind, randomized, multicentric clinical trial, 162 healthy participants with recurring infections received 900?mg of either placebo (n?=?81) or an insoluble yeast (1,3)-(1,6)-beta-d-glucan preparation (n?=?81) per day over a course of 16?weeks. Subjects were instructed to document each occurring common co...

  9. ELECTRICAL AND ELECTRONIC INDUSTRIAL CONTROL. BASIC ELECTRICITY, UNIT 2, ASSIGNMENTS.

    Science.gov (United States)

    SUTTON, MACK C.

    THIS GUIDE IS FOR INDIVIDUAL STUDENT USE IN STUDYING BASIC ELECTRICAL FUNDAMENTALS IN ELECTRICAL-ELECTRONIC PROGRAMS. IT WAS DEVELOPED BY AN INSTRUCTIONAL MATERIALS SPECIALIST AND ADVISERS. THE COURSE OBJECTIVE IS TO DEVELOP AN UNDERSTANDING OF DIRECT CURRENT FUNDAMENTALS. EACH OF THE 15 ASSIGNMENT SHEETS PROVIDES THE LESSON SUBJECT, PURPOSE,…

  10. Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial

    OpenAIRE

    Nuria eRuffini; Giandomenico eD'alessandro; Nicolò eMariani; Alberto ePollastrelli; Lucia eCardinali; Francesco eCerritelli

    2015-01-01

    Context: Heart Rate Variability (HRV) indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS) function. Objective: To investigate the influence of osteopathic manipulative treatment (OMT) on cardiac autonomic modulation in healthy subjects, compared with sham therapy and control group. Methods: Sixty-six healthy subjects, both male and female, were included in the present 3-ar...

  11. Pilot feasibility and safety study examining the effect of medium chain triglyceride supplementation in subjects with mild cognitive impairment: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Candida J. Rebello

    2015-06-01

    Conclusions: Consumption of 56 g/day of MCTs for 24 weeks increases serum ketone concentrations and appears to be a candidate for larger randomized control trials in the future that quantify the modulation of cognitive function through supplementation with ketone precursors, in patients with MCI.

  12. Effect of fish-oil supplementation on mental well-being in older subjects: a randomized, double-blind, placebo-controlled trial 1-3

    NARCIS (Netherlands)

    Rest, van de O.; Geleijnse, J.M.; Kok, F.J.; Staveren, van W.A.; Hoefnagels, W.H.; Beekman, A.T.F.; Groot, de C.P.G.M.

    2008-01-01

    Background: It is suggested that a low intake of fish and/or n¿3 PUFA is associated with depressed mood. However, results from epidemiologic studies are mixed, and randomized trials have mainly been performed in depressed patients, yielding conflicting results. Objective: We investigated the effect

  13. Assignment Choice, Effort, and Assignment Completion: Does Work Ethic Predict Those Who Choose Higher-Effort Assignments?

    Science.gov (United States)

    Parkhurst, John T.; Fleisher, Matthew S.; Skinner, Christopher H.; Woehr, David J.; Hawthorn-Embree, Meredith L.

    2011-01-01

    After completing the Multidimensional Work-Ethic Profile (MWEP), 98 college students were given a 20-problem math computation assignment and instructed to stop working on the assignment after completing 10 problems. Next, they were allowed to choose to finish either the partially completed assignment that had 10 problems remaining or a new…

  14. Subjective and Cardiovascular Effects of Intravenous Methamphetamine during Perindopril Maintenance: A Randomized, Double-Blind, Placebo-Controlled Human Laboratory Study.

    Science.gov (United States)

    Verrico, Christopher D; Haile, Colin N; De La Garza, Richard; Grasing, Kenneth; Kosten, Thomas R; Newton, Thomas F

    2016-07-01

    Our pilot study suggested that the angiotensin-converting enzyme inhibitor perindopril might reduce some subjective effects produced by i.v. methamphetamine. We characterized the impact of a wider range of perindopril doses on methamphetamine-induced effects in a larger group of non-treatment-seeking, methamphetamine-using volunteers. Before treatment, participants received 30mg methamphetamine. After 5 to 7 days of perindopril treatment (0, 4, 8, or 16mg/d), participants received 15 and 30mg of methamphetamine on alternate days. Before and after treatment, participants rated subjective effects and cardiovascular measures were collected. Prior to treatment with perindopril, there were no significant differences between treatment groups on maximum or peak subjective ratings or on peak cardiovascular effects. Following perindopril treatment, there were significant main effects of treatment on peak subjective ratings of "anxious" and "stimulated"; compared to placebo treatment, treatment with 8mg perindopril significantly reduced peak ratings of both anxious (P=.0009) and stimulated (P=.0070). There were no significant posttreatment differences between groups on peak cardiovascular effects. Moderate doses of perindopril (8mg) significantly reduced peak subjective ratings of anxious and stimulated as well as attenuated many other subjective effects produced by methamphetamine, likely by inhibiting angiotensin II synthesis. Angiotensin II is known to facilitate the effects of norepinephrine, which contributes to methamphetamine's subjective effects. The lack of a classic dose-response function likely results from either nonspecific effects of perindopril or from between-group differences that were not accounted for in the current study (i.e., genetic variations and/or caffeine use). The current findings suggest that while angiotensin-converting enzyme inhibitors can reduce some effects produced by methamphetamine, more consistent treatment effects might be achieved by

  15. Integrated assignment and path planning

    Science.gov (United States)

    Murphey, Robert A.

    2005-11-01

    A surge of interest in unmanned systems has exposed many new and challenging research problems across many fields of engineering and mathematics. These systems have the potential of transforming our society by replacing dangerous and dirty jobs with networks of moving machines. This vision is fundamentally separate from the modern view of robotics in that sophisticated behavior is realizable not by increasing individual vehicle complexity, but instead through collaborative teaming that relies on collective perception, abstraction, decision making, and manipulation. Obvious examples where collective robotics will make an impact include planetary exploration, space structure assembly, remote and undersea mining, hazardous material handling and clean-up, and search and rescue. Nonetheless, the phenomenon driving this technology trend is the increasing reliance of the US military on unmanned vehicles, specifically, aircraft. Only a few years ago, following years of resistance to the use of unmanned systems, the military and civilian leadership in the United States reversed itself and have recently demonstrated surprisingly broad acceptance of increasingly pervasive use of unmanned platforms in defense surveillance, and even attack. However, as rapidly as unmanned systems have gained acceptance, the defense research community has discovered the technical pitfalls that lie ahead, especially for operating collective groups of unmanned platforms. A great deal of talent and energy has been devoted to solving these technical problems, which tend to fall into two categories: resource allocation of vehicles to objectives, and path planning of vehicle trajectories. An extensive amount of research has been conducted in each direction, yet, surprisingly, very little work has considered the integrated problem of assignment and path planning. This dissertation presents a framework for studying integrated assignment and path planning and then moves on to suggest an exact

  16. Pediatric Online Evidence-Based Medicine Assignment Is a Novel Effective Enjoyable Undergraduate Medical Teaching Tool: A SQUIRE Compliant Study.

    Science.gov (United States)

    Kotb, Magd A; Elmahdy, Hesham Nabeh; Khalifa, Nour El Deen Mahmoud; El-Deen, Mohamed Hamed Nasr; Lotfi, Mohamed Amr N

    2015-07-01

    Evidence-based medicine (EBM) is delivered through a didactic, blended learning, and mixed models. Students are supposed to construct an answerable question in PICO (patient, intervention, comparison, and outcome) framework, acquire evidence through search of literature, appraise evidence, apply it to the clinical case scenario, and assess the evidence in relation to clinical context. Yet these teaching models have limitations especially those related to group work, for example, handling uncooperative students, students who fail to contribute, students who domineer, students who have personal conflict, their impact upon progress of their groups, and inconsistent individual acquisition of required skills. At Pediatrics Department, Faculty of Medicine, Cairo University, we designed a novel undergraduate pediatric EBM assignment online system to overcome shortcomings of previous didactic method and aimed to assess its effectiveness by prospective follow-up during academic years 2012 to 2013 and 2013 to 2014. The novel web-based online interactive system was tailored to provide sequential single and group assignments for each student. Single assignment addressed a specific case scenario question, while group assignment was teamwork that addressed different questions of same case scenario. Assignment comprised scholar content and skills. We objectively analyzed students' performance by criterion-based assessment and subjectively by anonymous student questionnaire. A total of 2879 were enrolled in 5th year Pediatrics Course consecutively, of them 2779 (96.5%) logged in and 2554 (88.7%) submitted their work. They were randomly assigned to 292 groups. A total of 2277 (89.15%) achieved ≥ 80% of total mark (4/5), of them 717 (28.1%) achieved a full mark. A total of 2178 (85.27%) and 2359 (92.36%) made evidence-based conclusions and recommendations in single and group assignment, respectively (P < 0.001). A total of 1102 (43.1%) answered student questionnaire, of them 898

  17. Managing voluntary turnover through challenging assignments

    NARCIS (Netherlands)

    Preenen, P.T.Y.; de Pater, I.E.; van Vianen, A.E.M.; Keijzer, L.

    2011-01-01

    This study examines employees’ challenging assignments as manageable means to reduce turnover intentions, job search behaviors, and voluntary turnover. Results indicate that challenging assignments are negatively related to turnover intentions and job search behaviors and that these relationships

  18. Managing voluntary turnover through challenging assignments

    NARCIS (Netherlands)

    Preenen, P.T.Y.; Pater, I.E. de; Vianen, A.E.M. van; Keijzer, L.

    2011-01-01

    This study examines employees' challenging assignments as manageable means to reduce turnover intentions, job search behaviors, and voluntary turnover. Results indicate that challenging assignments are negatively related to turnover intentions and job search behaviors and that these relationships

  19. Assigning historic responsibility for extreme weather events

    Science.gov (United States)

    Otto, Friederike E. L.; Skeie, Ragnhild B.; Fuglestvedt, Jan S.; Berntsen, Terje; Allen, Myles R.

    2017-11-01

    Recent scientific advances make it possible to assign extreme events to human-induced climate change and historical emissions. These developments allow losses and damage associated with such events to be assigned country-level responsibility.

  20. INDEXING WORKSHOP: HOW TO ASSIGN KEYWORDS

    Energy Technology Data Exchange (ETDEWEB)

    Sternberg, Virginia

    1979-09-01

    You have heard about issues surrounding indexing and retrieval of nuclear records and automation and micrographics of these records. Now we are going to get each of you involved in indexing and assigning keywords. The first part of this hands-on workshop will be a very basic, elementary step-by-step introduction, concentrating on how to assign keywords. It is a workshop for beginners, People who have never done it before. It is planned to demonstrate what an analyst has to do to index and assign keywords to a document. Then I will take some pages of a report and demonstrate how I choose keywords for it. Then each of you will have a chance to do the same thing with similar pages from another report. Then we will discuss the variations ln the keywords you individually assigned. There are many systems that can be used. In this particular workshop we will cover only a system of building your own keyword listing as you index your documents. We will be discussing keywords or descriptors or subject words, but first I want to point out a few other critical points about indexing. When developing an indexing project the most important thing to do first lS decide what elements you want to retrieve by. Whether you go into a large computer retrieval system or a small three-by-five card system, you have to decide in advance what you want to retrieve. Then you can go on from there. If you only need to search by equipment number or by purchase order or by contract number, then you can use a very simple retrieval system. But if you want to be able to retrieve a record by any combination of elements, then you have to consistently input these into your system. For example, if you want to be able to ask for the drawings of the piping in the secondary cooling system, level 3, manufactured by a certain vendor, then you must have put the information into the index by a retrieval file point, in advance. I want to stress that the time spent in deciding what has to be retrievable is never

  1. Assigning Homework to Couples and Families

    Science.gov (United States)

    Dattilio, Frank M.; Dickson, Jan

    2007-01-01

    Homework assignments, or "out-of-session assignments," have gained popularity among couple and family therapists due to their potential to solidify the work achieved during the course of therapy and to help clients take responsibility for their own change. Homework assignments also serve as a testing ground in therapy to determine what works and…

  2. Clinical Evaluation of Acupuncture as Treatment for Complications of Cerebrovascular Accidents: A Randomized, Sham-Controlled, Subject- and Assessor-Blind Trial.

    Science.gov (United States)

    Liao, Hsien-Yin; Ho, Wen-Chao; Chen, Chun-Chung; Lin, Jaung-Geng; Chang, Chia-Chi; Chen, Liang-Yu; Lee, De-Chih; Lee, Yu-Chen

    2017-01-01

    Background and Purpose. The effect of acupuncture as treatment for poststroke complications is questionable. We performed a randomized, sham-controlled double-blind study to investigate it. Methods. Patients with first-time acute stroke were randomized to receive 24 sessions of either real or sham acupuncture during an eight-week period. The primary outcome measure was change in National Institute of Health Stroke Scale (NIHSS) score. Secondary outcome measures included changes in Barthel Index (BI), Instrumental Activities of Daily Living (IADL), Hamilton Depression Rating Scale (HAM-D), and Visual Analogue Scale (VAS) for pain scores. Results. Of the 52 patients who were randomized to receive acupuncture (n = 28) or placebo (n = 24), 10 patients in the acupuncture group and 9 patients in the placebo group failed to complete the treatment. In total, 18 patients in the acupuncture group and 15 patients in the control group completed the treatment course. Reduction in pain was significantly greater in the acupuncture group than in the control group (p value = 0.04). There were no significant differences in the other measures between the two groups. Conclusions. Acupuncture provided more effective poststroke pain relief than sham acupuncture treatment. However, acupuncture had no better effect on neurological, functional, and psychological improvement.

  3. Clinical Evaluation of Acupuncture as Treatment for Complications of Cerebrovascular Accidents: A Randomized, Sham-Controlled, Subject- and Assessor-Blind Trial

    Directory of Open Access Journals (Sweden)

    Hsien-Yin Liao

    2017-01-01

    Full Text Available Background and Purpose. The effect of acupuncture as treatment for poststroke complications is questionable. We performed a randomized, sham-controlled double-blind study to investigate it. Methods. Patients with first-time acute stroke were randomized to receive 24 sessions of either real or sham acupuncture during an eight-week period. The primary outcome measure was change in National Institute of Health Stroke Scale (NIHSS score. Secondary outcome measures included changes in Barthel Index (BI, Instrumental Activities of Daily Living (IADL, Hamilton Depression Rating Scale (HAM-D, and Visual Analogue Scale (VAS for pain scores. Results. Of the 52 patients who were randomized to receive acupuncture (n=28 or placebo (n=24, 10 patients in the acupuncture group and 9 patients in the placebo group failed to complete the treatment. In total, 18 patients in the acupuncture group and 15 patients in the control group completed the treatment course. Reduction in pain was significantly greater in the acupuncture group than in the control group (p value = 0.04. There were no significant differences in the other measures between the two groups. Conclusions. Acupuncture provided more effective poststroke pain relief than sham acupuncture treatment. However, acupuncture had no better effect on neurological, functional, and psychological improvement.

  4. Lack of effect of risperidone or olanzapine dose reduction on subjective experiences in stable patients with schizophrenia.

    Science.gov (United States)

    Takeuchi, Hiroyoshi; Suzuki, Takefumi; Remington, Gary; Watanabe, Koichiro; Mimura, Masaru; Uchida, Hiroyuki

    2014-08-15

    Sixty-one patients with schizophrenia stably treated with risperidone or olanzapine were randomly assigned to dose-reduction-by-half group or dose maintenance group. Subjective experiences were assessed at baseline and 28 weeks using three different self-rating scales. No significant differences in changes of subjective experiences were observed between the two groups. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  5. Randomized trial on the effects of a combined physical/cognitive training in aged MCI subjects: the Train the Brain study

    Science.gov (United States)

    Maffei, L.; Picano, E.; Andreassi, M. G.; Angelucci, A.; Baldacci, F.; Baroncelli, L.; Begenisic, T.; Bellinvia, P. F.; Berardi, N.; Biagi, L.; Bonaccorsi, J.; Bonanni, E.; Bonuccelli, U.; Borghini, A.; Braschi, C.; Broccardi, M.; Bruno, R. M.; Caleo, M.; Carlesi, C.; Carnicelli, L.; Cartoni, G.; Cecchetti, L.; Cenni, M. C.; Ceravolo, R.; Chico, L.; Cintoli, S.; Cioni, G.; Coscia, M.; Costa, M.; D’Angelo, G.; D’Ascanio, P.; Nes, M. De; Turco, S. Del; Coscio, E. Di; Galante, M. Di; Lascio, N. di; Faita, F.; Falorni, I.; Faraguna, U.; Fenu, A.; Fortunato, L.; Franco, R.; Gargani, L.; Gargiulo, R.; Ghiadoni, L.; Giorgi, F. S.; Iannarella, R.; Iofrida, C.; Kusmic, C.; Limongi, F.; Maestri, M.; Maffei, M.; Maggi, S.; Mainardi, M.; Mammana, L.; Marabotti, A.; Mariotti, V.; Melissari, E.; Mercuri, A.; Micera, S.; Molinaro, S.; Narducci, R.; Navarra, T.; Noale, M.; Pagni, C.; Palumbo, S.; Pasquariello, R.; Pellegrini, S.; Pietrini, P.; Pizzorusso, T.; Poli, A.; Pratali, L.; Retico, A.; Ricciardi, E.; Rota, G.; Sale, A.; Sbrana, S.; Scabia, G.; Scali, M.; Scelfo, D.; Sicari, R.; Siciliano, G.; Stea, F.; Taddei, S.; Tognoni, G.; Tonacci, A.; Tosetti, M.; Turchi, S.; Volpi, L.

    2017-01-01

    Age-related cognitive impairment and dementia are an increasing societal burden. Epidemiological studies indicate that lifestyle factors, e.g. physical, cognitive and social activities, correlate with reduced dementia risk; moreover, positive effects on cognition of physical/cognitive training have been found in cognitively unimpaired elders. Less is known about effectiveness and action mechanisms of physical/cognitive training in elders already suffering from Mild Cognitive Impairment (MCI), a population at high risk for dementia. We assessed in 113 MCI subjects aged 65–89 years, the efficacy of combined physical-cognitive training on cognitive decline, Gray Matter (GM) volume loss and Cerebral Blood Flow (CBF) in hippocampus and parahippocampal areas, and on brain-blood-oxygenation-level-dependent (BOLD) activity elicited by a cognitive task, measured by ADAS-Cog scale, Magnetic Resonance Imaging (MRI), Arterial Spin Labeling (ASL) and fMRI, respectively, before and after 7 months of training vs. usual life. Cognitive status significantly decreased in MCI-no training and significantly increased in MCI-training subjects; training increased parahippocampal CBF, but no effect on GM volume loss was evident; BOLD activity increase, indicative of neural efficiency decline, was found only in MCI-no training subjects. These results show that a non pharmacological, multicomponent intervention improves cognitive status and indicators of brain health in MCI subjects. PMID:28045051

  6. Non-dipping pattern in ambulatory blood pressure monitoring is associated with metabolic abnormalities in a random sample of middle-aged subjects.

    Science.gov (United States)

    Ukkola, Olavi; Vasunta, Riitta-Liisa; Kesäniemi, Y Antero

    2009-11-01

    A reduction in the blood pressure decline at night (pattern') is associated with cardiovascular morbidity. Our aim was to evaluate whether ABPM characteristics are associated with metabolic abnormalities in subjects without known hypertension or type 2 diabetes mellitus (T2DM). This is a cross-sectional population-based study on middle-aged subjects (n=462). Two distinct definitions of metabolic syndrome (MetS) were used: National Cholesterol Education Program-Third Adult Treatment Panel (NCEP-ATPIII) and International Diabetes Federation (IDF) criteria. Results suggested that subjects characterized by non-dipping in 24 h ABPM were more obese (P=0.014). After adjustment for body mass index, age and sex, non-dippers had higher very-low-density lipoprotein (VLDL)-cholesterol (P=0.003), total (P=0.029)-and VLDL-triglycerides (P=0.026) and oral glucose tolerance test 2 h blood glucose (P=0.027) compared with dippers. Non-dipping status was more common among subjects with MetS (Ppattern. The percentage decline in blood pressure from day to night decreased with the number of metabolic abnormalities (P=0.012). In conclusion, ABPM non-dipping status is an independent predictor of glucose intolerance. It is also associated with several other metabolic abnormalities. Whether non-dipping pattern is causally related to these metabolic aberrations remains to be explored in a future prospective follow-up of this cohort.

  7. Randomized trial on the effects of a combined physical/cognitive training in aged MCI subjects: the Train the Brain study.

    Science.gov (United States)

    2017-01-03

    Age-related cognitive impairment and dementia are an increasing societal burden. Epidemiological studies indicate that lifestyle factors, e.g. physical, cognitive and social activities, correlate with reduced dementia risk; moreover, positive effects on cognition of physical/cognitive training have been found in cognitively unimpaired elders. Less is known about effectiveness and action mechanisms of physical/cognitive training in elders already suffering from Mild Cognitive Impairment (MCI), a population at high risk for dementia. We assessed in 113 MCI subjects aged 65-89 years, the efficacy of combined physical-cognitive training on cognitive decline, Gray Matter (GM) volume loss and Cerebral Blood Flow (CBF) in hippocampus and parahippocampal areas, and on brain-blood-oxygenation-level-dependent (BOLD) activity elicited by a cognitive task, measured by ADAS-Cog scale, Magnetic Resonance Imaging (MRI), Arterial Spin Labeling (ASL) and fMRI, respectively, before and after 7 months of training vs. usual life. Cognitive status significantly decreased in MCI-no training and significantly increased in MCI-training subjects; training increased parahippocampal CBF, but no effect on GM volume loss was evident; BOLD activity increase, indicative of neural efficiency decline, was found only in MCI-no training subjects. These results show that a non pharmacological, multicomponent intervention improves cognitive status and indicators of brain health in MCI subjects.

  8. Acute subjective effects after smoking joints containing up to 69 mg Δ9-tetrahydrocannabinol in recreational users : a randomized, crossover clinical trial

    NARCIS (Netherlands)

    Hunault, Claudine C.; Böcker, Koen B E; Stellato, R. K.; Kenemans, J. Leon; de Vries, Irma; Meulenbelt, Jan

    2014-01-01

    Rationale An increase in the potency of the cannabis cigarettes has been observed over the past three decades. Objectives In this study, we aimed to establish the impact of Δ9-tetrahydrocannabinol (THC) on the rating of subjective effects (intensity and duration of the effects), up to 23 % THC

  9. A randomized lifestyle intervention with 5-year follow-up in subjects with impaired glucose tolerance: pronounced short-term impact but long-term adherence problems

    DEFF Research Database (Denmark)

    Lindahl, Bernt; Nilssön, Torbjörn K; Borch-Johnsen, Knut

    2009-01-01

    between 1995 and 2000, in 168 individuals with impaired glucose tolerance (IGT) and body mass index above 27 at start. The intensive intervention group (n = 83) was subjected to a 1-month residential lifestyle programme. The usual care group (n = 85) participated in a health examination ending...

  10. Effects of AMG 145 on low-density lipoprotein cholesterol levels: results from 2 randomized, double-blind, placebo-controlled, ascending-dose phase 1 studies in healthy volunteers and hypercholesterolemic subjects on statins.

    Science.gov (United States)

    Dias, Clapton S; Shaywitz, Adam J; Wasserman, Scott M; Smith, Brian P; Gao, Bing; Stolman, Dina S; Crispino, Caroline P; Smirnakis, Karen V; Emery, Maurice G; Colbert, Alexander; Gibbs, John P; Retter, Marc W; Cooke, Blaire P; Uy, Stephen T; Matson, Mark; Stein, Evan A

    2012-11-06

    The aim of this study was to evaluate the safety, tolerability, and effects of AMG 145 on low-density lipoprotein cholesterol (LDL-C) in healthy and hypercholesterolemic subjects on statin therapy. Proprotein convertase subtilisin/kexin type 9 (PCSK9) down-regulates surface expression of the low-density lipoprotein receptor (LDL-R), increasing serum LDL-C. AMG 145, a fully human monoclonal antibody to PCSK9, prevents PCSK9/LDL-R interaction, restoring LDL-R recycling. Healthy adults (phase 1a) were randomized to 1 dose of AMG 145: 7, 21, 70, 210, or 420 mg SC; 21 or 420 mg IV; or matching placebo. Hypercholesterolemic adults (phase 1b) receiving low- to moderate-dose statins were randomized to multiple SC doses of AMG 145: 14 or 35 mg once weekly (QW) ×6, 140 or 280 mg every 2 weeks (Q2W) ×3, 420 mg every 4 weeks ×2, or matching placebo. Eleven subjects receiving high-dose statins and 6 subjects with heterozygous familial hypercholesterolemia were randomized to SC AMG 145 140 mg or placebo Q2W ×3. In the trials (AMG 145 n = 85, placebo n = 28), AMG 145 reduced LDL-C up to 64% (p AMG 145 versus placebo groups: 69% versus 71% (phase 1a); 65% versus 64% (phase 1b). In phase 1 studies, AMG 145 significantly reduced serum LDL-C in healthy and hypercholesterolemic statin-treated subjects, including those with heterozygous familial hypercholesterolemia or taking the highest doses of atorvastatin or rosuvastatin, with an overall AE profile similar to placebo. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  11. The influence of expectation on spinal manipulation induced hypoalgesia: an experimental study in normal subjects.

    Science.gov (United States)

    Bialosky, Joel E; Bishop, Mark D; Robinson, Michael E; Barabas, Josh A; George, Steven Z

    2008-02-11

    The mechanisms thorough which spinal manipulative therapy (SMT) exerts clinical effects are not established. A prior study has suggested a dorsal horn modulated effect; however, the role of subject expectation was not considered. The purpose of the current study was to determine the effect of subject expectation on hypoalgesia associated with SMT. Sixty healthy subjects agreed to participate and underwent quantitative sensory testing (QST) to their leg and low back. Next, participants were randomly assigned to receive a positive, negative, or neutral expectation instructional set regarding the effects of a specific SMT technique on pain perception. Following the instructional set, all subjects received SMT and underwent repeat QST. No interaction (p = 0.38) between group assignment and pain response was present in the lower extremity following SMT; however, a main effect (p influence of expectation on SMT induced hypoalgesia in the body area to which the expectation is directed.

  12. Influence of the Lactotripeptides Isoleucine-Proline-Proline and Valine-Proline-Proline on Systolic Blood Pressure in Japanese Subjects: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Aurelie Chanson-Rolle

    Full Text Available The lactotripeptides isoleucine-proline-proline (IPP and valine-proline-proline (VPP have been shown to decrease systolic blood pressure (SBP in several populations, but the size of the effect varies among studies. We performed a meta-analysis including all published studies to evaluate the SBP-lowering effect of IPP/VPP in Japanese subjects more comprehensively.Eligible randomized controlled trials were searched for within four bibliographic databases, including two Japanese ones. Eighteen studies (including a total of 1194 subjects were included in the meta-analysis. A random effect model using the restricted maximum likelihood (REML estimator was used for the analysis. The analysis showed that consumption of IPP/VPP induced a significant reduction in SBP as compared with placebo in Japanese subjects, with an estimated effect of -5.63 mm Hg (95% CI, -6.87 to -4.39, P<0.0001 and no evidence of publication bias. A significant heterogeneity between series was evident, which could be explained by a significant influence of the baseline blood pressure status of the subjects, the effect of IPP/VPP on SBP being stronger in hypertensive subjects (-8.35 mm Hg, P<0.0001 than in non-hypertensive subjects (-3.42mm Hg, P<0.0001. Furthermore, the effect of IPP/VPP on SBP remained significant when limiting the analysis to series that tested the usual doses of IPP/VPP consumed daily (below 5 mg/d, with estimated effects of -6.01 mm Hg in the overall population and -3.32 mm Hg in non-hypertensive subjects.Results from this meta-analysis show that IPP/VPP lactotripeptides can significantly reduce office SBP in Japanese subjects with or without overt hypertension, and for doses that can potentially be consumed as an everyday supplement. This suggests that these peptides could play a role in controlling blood pressure in Japanese subjects. The systematic review protocol was published on the PROSPERO register (CRD42014014322.

  13. Mobile access to virtual randomization for investigator-initiated trials.

    Science.gov (United States)

    Deserno, Thomas M; Keszei, András P

    2017-08-01

    Background/aims Randomization is indispensable in clinical trials in order to provide unbiased treatment allocation and a valid statistical inference. Improper handling of allocation lists can be avoided using central systems, for example, human-based services. However, central systems are unaffordable for investigator-initiated trials and might be inaccessible from some places, where study subjects need allocations. We propose mobile access to virtual randomization, where the randomization lists are non-existent and the appropriate allocation is computed on demand. Methods The core of the system architecture is an electronic data capture system or a clinical trial management system, which is extended by an R interface connecting the R server using the Java R Interface. Mobile devices communicate via the representational state transfer web services. Furthermore, a simple web-based setup allows configuring the appropriate statistics by non-statisticians. Our comprehensive R script supports simple randomization, restricted randomization using a random allocation rule, block randomization, and stratified randomization for un-blinded, single-blinded, and double-blinded trials. For each trial, the electronic data capture system or the clinical trial management system stores the randomization parameters and the subject assignments. Results Apps are provided for iOS and Android and subjects are randomized using smartphones. After logging onto the system, the user selects the trial and the subject, and the allocation number and treatment arm are displayed instantaneously and stored in the core system. So far, 156 subjects have been allocated from mobile devices serving five investigator-initiated trials. Conclusion Transforming pre-printed allocation lists into virtual ones ensures the correct conduct of trials and guarantees a strictly sequential processing in all trial sites. Covering 88% of all randomization models that are used in recent trials, virtual randomization

  14. Subjective and Cardiovascular Effects of Intravenous Methamphetamine during Perindopril Maintenance: A Randomized, Double-Blind, Placebo-Controlled Human Laboratory Study

    OpenAIRE

    Verrico, Christopher D.; Haile, Colin N.; De La Garza, Richard; Grasing, Kenneth; Kosten, Thomas R.; Newton, Thomas F.

    2016-01-01

    Background: Our pilot study suggested that the angiotensin-converting enzyme inhibitor perindopril might reduce some subjective effects produced by i.v. methamphetamine. We characterized the impact of a wider range of perindopril doses on methamphetamine-induced effects in a larger group of non-treatment-seeking, methamphetamine-using volunteers. Methods: Before treatment, participants received 30mg methamphetamine. After 5 to 7 days of perindopril treatment (0, 4, 8, or 16mg/d), participants...

  15. A randomized, double-blind placebo-controlled study on acceptability, safety and efficacy of oral administration of sacha inchi oil (Plukenetia volubilis L.) in adult human subjects.

    Science.gov (United States)

    Gonzales, Gustavo F; Gonzales, Carla

    2014-03-01

    The study was designed to assess acceptability and side-effects of consumption of sacha inchi oil, rich in α-linolenic acid and sunflower oil, rich in linoleic acid, in adult human subjects. Thirty subjects received 10 or 15ml daily of sacha inchi or sunflower oil for 4months. Acceptability was assessed with daily self-report and with a Likert test at the end of the study. Safety was assessed with self- recording of side-effects and with hepatic and renal markers. Primary efficacy variables were the change in lipid profile. Subjects reported low acceptability of sacha inchi oil at week-1 (37.5%). However, since week-6, acceptability was significantly increased to 81.25-93.75%. No differences were observed in acceptability with respect to sex or oil volume (P>0.05). Most frequent adverse effects during first weeks of consuming sacha inchi oil or sunflower oil were nauseas. The side-effects were reduced with time. Biochemical markers of hepatic and kidney function were maintained unchanged. Serum total cholesterol and LDL cholesterol levels and arterial blood pressure were lowered with both oils (P<0.05). Higher HDL-cholesterol was observed with sacha inchi oil at month-4. In conclusion, sacha inchi oil consumed has good acceptability after week-1 of consumption and it is safety. Copyright © 2014 Elsevier Ltd. All rights reserved.

  16. Chronic consumption of an inositol-enriched carob extract improves postprandial glycaemia and insulin sensitivity in healthy subjects: A randomized controlled trial.

    Science.gov (United States)

    Bañuls, Celia; Rovira-Llopis, Susana; Falcón, Rosa; Veses, Silvia; Monzó, Nuria; Víctor, Víctor M; Rocha, Milagros; Hernández-Mijares, Antonio

    2016-06-01

    Inositols are thought to be mediators of the insulin signalling pathway. We assessed the effects of inositols on glycaemic control in fasting and postprandial states and evaluated lipoprotein profile and LDL particle size in healthy population. A 12-week double-blind clinical trial was performed with forty healthy subjects administered either an inositol-enriched beverage (IEB) -containing 2.23 g of inositols in 250 ml- or a sucrose-sweetened beverage (SB) twice a day. Anthropometric measurements, fasting glucose levels, insulin and HOMA-IR index, lipoprotein profile and postprandial glucose concentrations (measured using the continuous glucose monitoring system (CGMS)) were recorded throughout the intervention period. Following the 12-week trial subjects receiving the IEB exhibited a significant decrease in insulin, HOMA-IR and Apo B and an increase in LDL particle size, whereas the SB group showed increases in BMI and fasting glucose concentration. Analysis of postprandial glucose levels at breakfast, lunch and dinner revealed a mean reduction of glucose of ≈14% and a significant reduction in the area under the curve at 24 h after consumption of the IEB. Our results show that chronic IEB supplementation induces a significant improvement in carbohydrated metabolism parameters in healthy subjects. Copyright © 2015 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  17. Short-Term Effects of Whole-Body Vibration Combined with Task-Related Training on Upper Extremity Function, Spasticity, and Grip Strength in Subjects with Poststroke Hemiplegia: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Lee, Jung-Sun; Kim, Chang-Yong; Kim, Hyeong-Dong

    2016-08-01

    The aim of this study was to determine the effect of whole-body vibration training combined with task-related training on arm function, spasticity, and grip strength in subjects with poststroke hemiplegia. Forty-five subjects with poststroke were randomly allocated to 3 groups, each with 15 subjects as follows: control group, whole-body vibration group, and whole-body vibration plus task-related training group. Outcome was evaluated by clinical evaluation and measurements of the grip strength before and 4 weeks after intervention. Our results show that there was a significantly greater increase in the Fugl-Meyer scale, maximal grip strength of the affected hand, and grip strength normalized to the less affected hand in subjects undergoing the whole-body vibration training compared with the control group after the test. Furthermore, there was a significantly greater increase in the Wolf motor function test and a decrease in the modified Ashworth spasticity total scores in subjects who underwent whole-body vibration plus task-related training compared with those in the other 2 groups after the test. The findings indicate that the use of whole-body vibration training combined with task-related training has more benefits on the improvement of arm function, spasticity, and maximal grip strength than conventional upper limb training alone or with whole-body vibration in people with poststroke hemiplegia.

  18. Constrained Task Assignment and Scheduling On Networks of Arbitrary Topology

    Science.gov (United States)

    Jackson, Justin Patrick

    This dissertation develops a framework to address centralized and distributed constrained task assignment and task scheduling problems. This framework is used to prove properties of these problems that can be exploited, develop effective solution algorithms, and to prove important properties such as correctness, completeness and optimality. The centralized task assignment and task scheduling problem treated here is expressed as a vehicle routing problem with the goal of optimizing mission time subject to mission constraints on task precedence and agent capability. The algorithm developed to solve this problem is able to coordinate vehicle (agent) timing for task completion. This class of problems is NP-hard and analytical guarantees on solution quality are often unavailable. This dissertation develops a technique for determining solution quality that can be used on a large class of problems and does not rely on traditional analytical guarantees. For distributed problems several agents must communicate to collectively solve a distributed task assignment and task scheduling problem. The distributed task assignment and task scheduling algorithms developed here allow for the optimization of constrained military missions in situations where the communication network may be incomplete and only locally known. Two problems are developed. The distributed task assignment problem incorporates communication constraints that must be satisfied; this is the Communication-Constrained Distributed Assignment Problem. A novel distributed assignment algorithm, the Stochastic Bidding Algorithm, solves this problem. The algorithm is correct, probabilistically complete, and has linear average-case time complexity. The distributed task scheduling problem addressed here is to minimize mission time subject to arbitrary predicate mission constraints; this is the Minimum-time Arbitrarily-constrained Distributed Scheduling Problem. The Optimal Distributed Non-sequential Backtracking Algorithm

  19. Randomized, double-blind, placebo-controlled, linear dose, crossover study to evaluate the efficacy and safety of a green coffee bean extract in overweight subjects

    Directory of Open Access Journals (Sweden)

    Vinson JA

    2012-01-01

    Full Text Available Joe A Vinson1, Bryan R Burnham3, Mysore V Nagendran31Chemistry Department, 2Psychology Department, University of Scranton, Scranton, PA, USA; 3Health Sciences Clinic, Bangalore, IndiaBackground: Adult weight gain and obesity have become worldwide problems. Issues of cost and potential side effects of prescription weight loss drugs have led overweight and obese adults to try nutraceuticals that may aid weight loss. One promising nutraceutical is green coffee extract, which contains high concentrations of chlorogenic acids hat are known to have health benefits and to influence glucose and fat metabolism. A 22-week crossover study was conducted to examine the efficacy and safety of a commercial green coffee extract product GCA™ at reducing weight and body mass in 16 overweight adults.Methods: Subjects received high-dose GCA (1050 mg, low-dose GCA (700 mg, or placebo in separate six-week treatment periods followed by two-week washout periods to reduce any influence of preceding treatment. Treatments were counterbalanced between subjects. Primary measurements were body weight, body mass index, and percent body fat. Heart rate and blood pressure were also measured.Results: Significant reductions were observed in body weight (-8.04 ± 2.31 kg, body mass index (-2.92 ± 0.85 kg/m2, and percent body fat (-4.44% ± 2.00%, as well as a small decrease in heart rate (-2.56 ± 2.85 beats per minute, but with no significant changes to diet over the course of the study. Importantly, the decreases occurred when subjects were taking GCA. Body mass index for six subjects shifted from preobesity to the normal weight range (<25.00 kg/m2.Conclusion: The results are consistent with human and animal studies and a meta-analysis of the efficacy of green coffee extract in weight loss. The results suggest that GCA may be an effective nutraceutical in reducing weight in preobese adults, and may be an inexpensive means of preventing obesity in overweight adults

  20. Prevention of overuse injuries by a concurrent exercise program in subjects exposed to an increase in training load: a randomized controlled trial of 1020 army recruits

    DEFF Research Database (Denmark)

    Brushøj, Christoffer; Larsen, Klaus; Albrecht-Beste, Elisabeth

    2008-01-01

    BACKGROUND: It is unknown whether an exercise program can prevent overuse injuries in the lower extremity. An often encountered and important risk factor for the development of lower extremity overuse injuries is an abrupt increase in activity level. HYPOTHESIS: A preventive training program based...... on a literature review of intrinsic risk factors, and performed concurrent with an increase in physical activity, can reduce the incidence of overuse knee injuries and medial tibial stress syndrome, as well as increase running distance. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS......: A total of 1020 soldiers aged 20.9 years (range, 19-26 years) undergoing 3 months of basic military training consecutively enrolled from December 2004 to December 2005. The prevention program consisted of an exercise program of 15 minutes' duration 3 times a week, including 5 exercises for strength...

  1. A probabilistic approach to the dynamic analysis of ducts subjected to multibase harmonic and random excitation. [for Space Shuttle Main Engine

    Science.gov (United States)

    Debchaudhury, Amit; Rajagopal, K. R.; Ho, H.; Newell, J. F.

    1990-01-01

    The dynamic behavior of the discharge duct of the high-pressure oxidizer turbopump of a cryogenic rocket motor is investigated analytically. The probabilistic analysis program NESSUS (Numerical Evaluation of Stochastic Structures Under Stress; Cruse et al., 1988) is used to treat the uncertainties due to random and harmonic excitation (e.g., pump noise, pump-induced harmonics, and combustion noise), variations in engine inlet pressure, and changes in system damping. The load modeling procedure, the variation in power-spectral density in different zones of the engine structure, and the dynamic structural-analysis technique are described, and the numerical results of the NESSUS analysis are presented in extensive tables and graphs and discussed in detail.

  2. Proof-of-Concept Randomized Controlled Study of Cognition Effects of the Proprietary Extract Sceletium tortuosum (Zembrin Targeting Phosphodiesterase-4 in Cognitively Healthy Subjects: Implications for Alzheimer’s Dementia

    Directory of Open Access Journals (Sweden)

    Simon Chiu

    2014-01-01

    Full Text Available Introduction. Converging evidence suggests that PDE-4 (phosphodiesterase subtype 4 plays a crucial role in regulating cognition via the PDE-4-cAMP cascade signaling involving phosphorylated cAMP response element binding protein (CREB. Objective. The primary endpoint was to examine the neurocognitive effects of extract Sceletium tortuosum (Zembrin and to assess the safety and tolerability of Zembrin in cognitively healthy control subjects. Method. We chose the randomized double-blind placebo-controlled cross-over design in our study. We randomized normal healthy subjects (total n=21 to receive either 25 mg capsule Zembrin or placebo capsule once daily for 3 weeks, in a randomized placebo-controlled 3-week cross-over design. We administered battery of neuropsychological tests: CNS Vital Signs and Hamilton depression rating scale (HAM-D at baseline and regular intervals and monitored side effects with treatment emergent adverse events scale. Results. 21 subjects (mean age: 54.6 years ± 6.0 yrs; male/female ratio: 9/12 entered the study. Zembrin at 25 mg daily dosage significantly improved cognitive set flexibility (P<0.032 and executive function (P<0.022, compared with the placebo group. Positive changes in mood and sleep were found. Zembrin was well tolerated. Conclusion. The promising cognitive enhancing effects of Zembrin likely implicate the PDE-4-cAMP-CREB cascade, a novel drug target in the potential treatment of early Alzheimer’s dementia. This trial is registered with ClinicalTrials.gov NCT01805518.

  3. Medicare Part D Roulette, Potential Implications of Random..

    Data.gov (United States)

    U.S. Department of Health & Human Services — Medicare Part D Roulette, Potential Implications of Random Assignment and Plan Restrictions Dual-eligible (Medicare and Medicaid) beneficiaries are randomly assigned...

  4. The cognitive and psychomotor effects of opioid analgesics. I. A randomized controlled trial of single doses of dextropropoxyphene, lorazepam and placebo in healthy subjects.

    Science.gov (United States)

    O'Neill, W M; Hanks, G W; White, L; Simpson, P; Wesnes, K

    1995-01-01

    Twelve subjects (3 male) took part in a randomised double-blind four way crossover study designed to examine the cognitive and psychomotor effects of single doses of dextroproxyphene. On four study days one week apart each subject received each study product (i) dextropropoxyphene napsylate 100 mg, (ii) dextropropoxyphene napsylate 200 mg, (iii) lorazepam 2 mg and (iv) placebo. Performance measures were simple reaction time, choice reaction time, number vigilance, memory scanning, word recall (immediate and delayed), word recognition, picture recognition, critical flicker fusion threshold (CFFT) and visual analogue scales of alertness, calmness and contentment. Lorazepam had a marked effect on the range of tests used illustrating the sensitivity of the best battery. This was in contrast to the effects of dextropropoxyphene. A dose related effect in CFFT was detected, the 200 mg dose producing a significant decrease in CFFT throughout the testing period. Dextropropoxyphene also showed a tendency to improve scores on the verbal memory tasks. These data indicate that dextropropoxyphene in the usual doses does not produce significant impairment of cognitive and psychomotor function.

  5. Library-Based Assignments That Enrich the Business Communication Course.

    Science.gov (United States)

    Hiemstra, Kathleen M.

    2002-01-01

    Reviews the benefits of library work (and some cautions) before describing four assignments that exploit library resources: a business report assignment; a professional journal assignment; a style manual format assignment; and an international business communication assignment. (SG)

  6. Two randomized, double-blind, controlled trials of 2219 subjects to compare the combination clindamycin/tretinoin hydrogel with each agent alone and vehicle for the treatment of acne vulgaris.

    Science.gov (United States)

    Leyden, James J; Krochmal, Lincoln; Yaroshinsky, Alex

    2006-01-01

    The development of a hydrogel to stabilize and solubilize clindamycin and tretinoin provides a single, once-daily treatment for acne vulgaris. Our aim was to compare the efficacy and safety of the combination of clindamycin (1%) and tretinoin (0.025%) with each agent alone and vehicle. Two randomized, double-blind, active drug- and vehicle-controlled 12-week studies evaluated inflammatory and noninflammatory lesion counts and the Investigator's Static Global Assessment in 2219 subjects with acne vulgaris. The combination demonstrated superior efficacy to clindamycin, tretinoin, and vehicle. Combination hydrogel was significantly more effective in reducing inflammatory (P acne vulgaris at baseline; therefore these overall results may not be representative of the response in the subjects (17.4%) with grade 4-5 acne. The combination clindamycin/tretinoin hydrogel was well tolerated and significantly more effective than clindamycin, tretinoin, or vehicle for the treatment of acne vulgaris.

  7. A Dietary Supplement Containing Cinnamon, Chromium and Carnosine Decreases Fasting Plasma Glucose and Increases Lean Mass in Overweight or Obese Pre-Diabetic Subjects: A Randomized, Placebo-Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Yuejun Liu

    Full Text Available Preventing or slowing the progression of prediabetes to diabetes is a major therapeutic issue.Our aim was to evaluate the effects of 4-month treatment with a dietary supplement containing cinnamon, chromium and carnosine in moderately obese or overweight pre-diabetic subjects, the primary outcome being change in fasting plasma glucose (FPG level. Other parameters of plasma glucose homeostasis, lipid profile, adiposity and inflammatory markers were also assessed.In a randomized, double-blind, placebo-controlled study, 62 subjects with a FPG level ranging from 5.55 to 7 mmol/L and a body mass index ≥ 25 kg/m(2, unwilling to change their dietary and physical activity habits, were allocated to receive a 4-month treatment with either 1.2 g/day of the dietary supplement or placebo. Patients were followed up until 6 months post-randomization.Four-month treatment with the dietary supplement decreased FPG compared to placebo (-0.24 ± 0.50 vs +0.12 ± 0.59 mmol/L, respectively, p = 0.02, without detectable significant changes in HbA1c. Insulin sensitivity markers, plasma insulin, plasma lipids and inflammatory markers did not differ between the treatment groups. Although there were no significant differences in changes in body weight and energy or macronutrient intakes between the two groups, fat-free mass (% increased with the dietary supplement compared to placebo (p = 0.02. Subjects with a higher FPG level and a milder inflammatory state at baseline benefited most from the dietary supplement.Four-month treatment with a dietary supplement containing cinnamon, chromium and carnosine decreased FPG and increased fat-free mass in overweight or obese pre-diabetic subjects. These beneficial effects might open up new avenues in the prevention of diabetes.ClinicalTrials.gov NCT01530685.

  8. Enhancement of a modified Mediterranean-style, low glycemic load diet with specific phytochemicals improves cardiometabolic risk factors in subjects with metabolic syndrome and hypercholesterolemia in a randomized trial

    Directory of Open Access Journals (Sweden)

    Babish John G

    2008-11-01

    Full Text Available Abstract Background As the worldwide dietary pattern becomes more westernized, the metabolic syndrome is reaching epidemic proportions. Lifestyle modifications including diet and exercise are recommended as first-line intervention for treating metabolic syndrome. Previously, we reported that a modified Mediterranean-style, low glycemic load diet with soy protein and phytosterols had a more favorable impact than the American Heart Association Step 1 diet on cardiovascular disease (CVD risk factors. Subsequently, we screened for phytochemicals with a history of safe use that were capable of increasing insulin sensitivity through modulation of protein kinases, and identified hops rho iso-alpha acid and acacia proanthocyanidins. The objective of this study was to investigate whether enhancement of a modified Mediterranean-style, low glycemic load diet (MED with specific phytochemicals (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED could improve cardiometabolic risk factors in subjects with metabolic syndrome and hypercholesterolemia. Methods Forty-nine subjects with metabolic syndrome and hypercholesterolemia, aged 25–80, entered a randomized, 2-arm, 12-week intervention trial; 23 randomized to the MED arm; 26 to the PED arm. Forty-four subjects completed at least 8 weeks [MED (n = 19; PED (n = 25]. All subjects were instructed to follow the same aerobic exercise program. Three-day diet diaries and 7-day exercise diaries were assessed at each visit. Fasting blood samples were collected at baseline, 8 and 12 weeks for analysis. Results Both arms experienced equal weight loss (MED: -5.7 kg; PED: -5.9 kg. However, at 12 weeks, the PED arm experienced greater reductions (P P P P P Conclusion These results demonstrate that specific phytochemical supplementation increased the effectiveness of the modified Mediterranean-style low glycemic load dietary program on variables associated with metabolic syndrome and CVD.

  9. Enhancement of a modified Mediterranean-style, low glycemic load diet with specific phytochemicals improves cardiometabolic risk factors in subjects with metabolic syndrome and hypercholesterolemia in a randomized trial.

    Science.gov (United States)

    Lerman, Robert H; Minich, Deanna M; Darland, Gary; Lamb, Joseph J; Schiltz, Barbara; Babish, John G; Bland, Jeffrey S; Tripp, Matthew L

    2008-11-04

    As the worldwide dietary pattern becomes more westernized, the metabolic syndrome is reaching epidemic proportions. Lifestyle modifications including diet and exercise are recommended as first-line intervention for treating metabolic syndrome. Previously, we reported that a modified Mediterranean-style, low glycemic load diet with soy protein and phytosterols had a more favorable impact than the American Heart Association Step 1 diet on cardiovascular disease (CVD) risk factors. Subsequently, we screened for phytochemicals with a history of safe use that were capable of increasing insulin sensitivity through modulation of protein kinases, and identified hops rho iso-alpha acid and acacia proanthocyanidins. The objective of this study was to investigate whether enhancement of a modified Mediterranean-style, low glycemic load diet (MED) with specific phytochemicals (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED) could improve cardiometabolic risk factors in subjects with metabolic syndrome and hypercholesterolemia. Forty-nine subjects with metabolic syndrome and hypercholesterolemia, aged 25-80, entered a randomized, 2-arm, 12-week intervention trial; 23 randomized to the MED arm; 26 to the PED arm. Forty-four subjects completed at least 8 weeks [MED (n = 19); PED (n = 25)]. All subjects were instructed to follow the same aerobic exercise program. Three-day diet diaries and 7-day exercise diaries were assessed at each visit. Fasting blood samples were collected at baseline, 8 and 12 weeks for analysis. Both arms experienced equal weight loss (MED: -5.7 kg; PED: -5.9 kg). However, at 12 weeks, the PED arm experienced greater reductions (P phytochemical supplementation increased the effectiveness of the modified Mediterranean-style low glycemic load dietary program on variables associated with metabolic syndrome and CVD.

  10. Pomegranate juice, but not an extract, confers a lower glycemic response on a high-glycemic index food: randomized, crossover, controlled trials in healthy subjects.

    Science.gov (United States)

    Kerimi, Asimina; Nyambe-Silavwe, Hilda; Gauer, Julia S; Tomás-Barberán, Francisco A; Williamson, Gary

    2017-10-11

    Background: Low-glycemic index diets have demonstrated health benefits associated with a reduced risk of developing type 2 diabetes.Objectives: We tested whether pomegranate polyphenols could lower the glycemic response of a high-glycemic index food when consumed together and the mechanism by which this might occur.Design: We compared the acute effect of a pomegranate juice and a polyphenol-rich extract from pomegranate (supplement) on the bread-derived postprandial blood glucose concentration in 2 randomized, crossover, controlled studies (double-blinded for the supplements), each on 16 healthy volunteers. An additional randomized, crossover, controlled study on 16 volunteers consuming constituent fruit acids in a pH-balanced solution (same pH as pomegranate) and bread was conducted to determine any contributions to postprandial responses caused by acidic beverages.Results: As primary outcome, the incremental area under the curve for bread-derived blood glucose (-33.1% ± 18.1%, P = 0.000005) and peak blood glucose (25.4% ± 19.3%, P = 0.0004) were attenuated by pomegranate juice, compared with a control solution containing the equivalent amount of sugars. In contrast, the pomegranate supplement, or a solution containing the malic and citric acid components of the juice, was ineffective. The pomegranate polyphenol punicalagin was a very effective inhibitor of human α-amylase in vitro, comparable to the drug acarbose. Neither the pomegranate extract nor the individual component polyphenols inhibited 14C-D-glucose transport across differentiated Caco-2/TC7 cell monolayers, but they inhibited uptake of 14C-glucose into Xenopus oocytes expressing the human glucose transporter type 2. Further, some of the predicted pomegranate gut microbiota metabolites modulated 14C-D-glucose and 14C-deoxy-D-glucose uptake into hepatic HepG2 cells.Conclusions: These data indicate that pomegranate polyphenols, when present in a beverage but not in a supplement, can reduce the

  11. Phase I, Randomized, Double-blind, Placebo-controlled, Single-dose, and Multiple-dose Studies of Erenumab in Healthy Subjects and Patients With Migraine.

    Science.gov (United States)

    de Hoon, Jan; Van Hecken, Anne; Vandermeulen, Corinne; Yan, Lucy; Smith, Brian; Chen, Jiyun Sunny; Bautista, Edgar; Hamilton, Lisa; Waksman, Javier; Vu, Thuy; Vargas, Gabriel

    2017-07-24

    Monoclonal antibodies (mAbs) targeting calcitonin gene-related peptide (CGRP) signaling are being explored as prophylactic treatments for migraine. Erenumab (AMG 334) is the first potent, selective, and competitive human mAb antagonist of the CGRP receptor. We report the data from two phase I studies assessing the safety, pharmacokinetics (PK), and pharmacodynamics of single and multiple administrations of erenumab in healthy subjects and patients with migraine. The results indicate that the PK profile of erenumab is nonlinear from 1 mg to 70 mg and the linear portion of the clearance from 70 mg to 210 mg is consistent with other human immunoglobulin G2 antibodies. Single doses of erenumab resulted in >75% inhibition of capsaicin-induced dermal blood flow, with no apparent dose-dependency for erenumab ≥21 mg. Erenumab was generally well tolerated, with an acceptable safety profile, supporting further clinical development of erenumab for migraine prevention. © 2017 American Society for Clinical Pharmacology and Therapeutics.

  12. Stochastic resonance energy harvesting for a rotating shaft subject to random and periodic vibrations: influence of potential function asymmetry and frequency sweep

    Science.gov (United States)

    Kim, Hongjip; Che Tai, Wei; Zhou, Shengxi; Zuo, Lei

    2017-11-01

    Stochastic resonance is referred to as a physical phenomenon that is manifest in nonlinear systems whereby a weak periodic signal can be significantly amplified with the aid of inherent noise or vice versa. In this paper, stochastic resonance is considered to harvest energy from two typical vibrations in rotating shafts: random whirl vibration and periodic stick-slip vibration. Stick-slip vibrations impose a constant offset in centrifugal force and distort the potential function of the harvester, leading to potential function asymmetry. A numerical analysis based on a finite element method was conducted to investigate stochastic resonance with potential function asymmetry. Simulation results revealed that a harvester with symmetric potential function generates seven times higher power than that with asymmetric potential function. Furthermore, a frequency-sweep analysis also showed that stochastic resonance has hysteretic behavior, resulting in frequency difference between up-sweep and down-sweep excitations. An electromagnetic energy harvesting system was constructed to experimentally verify the numerical analysis. In contrast to traditional stochastic resonance harvesters, the proposed harvester uses magnetic force to compensate the offset in the centrifugal force. System identification was performed to obtain the parameters needed in the numerical analysis. With the identified parameters, the numerical simulations showed good agreement with the experiment results with around 10% error, which verified the effect of potential function asymmetry and frequency sweep excitation condition on stochastic resonance. Finally, attributed to compensating the centrifugal force offset, the proposed harvester generated nearly three times more open-circuit output voltage than its traditional counterpart.

  13. Serum concentrations and gene expression of sirtuin 1 in healthy and slightly overweight subjects after caloric restriction or resveratrol supplementation: A randomized trial.

    Science.gov (United States)

    Mansur, Antonio P; Roggerio, Alessandra; Goes, Marisa F S; Avakian, Solange D; Leal, Dalila P; Maranhão, Raul C; Strunz, Célia M C

    2017-01-15

    Sirtuin 1 (Sirt1) plays an important role in vascular biology, and influences aspects of age-dependent atherosclerosis. In animals, the sirtuin system is strongly influenced by resveratrol and caloric restriction, but its expression in humans is controversial. This study investigated the effects of resveratrol and caloric restriction on Sirt1 serum concentrations and vascular biomarkers in a healthy human population. Forty-eight healthy participants (24 women) aged 55-65years were randomized to either 30days of resveratrol administration (500mg/day) or caloric restriction (1000cal/day). Blood was collected at baseline and day 30. Laboratory data analyzed were triglycerides, total cholesterol, HDL, VLDL, LDL, apolipoprotein A1, apolipoprotein B, lipoprotein (a), non-esterified fatty acids (NEFA), glucose, insulin, oxidative stress, C-reactive protein, and Sirt1. Expression of the Sirt1 gene was analyzed using real-time PCR. Caloric restriction diminished the abdominal circumference and improved the lipid profile, but not resveratrol intervention. Resveratrol and caloric restriction increased serum concentrations of Sirt1, from 1.06±0.71 to 5.75±2.98ng/mL; presveratrol treatment. Caloric restriction and resveratrol significantly increased plasma concentrations of Sirt1. The long-term impact of these interventions on atherosclerosis should be assessed. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  14. Post-prandial effects of hazelnut-enriched high fat meal on LDL oxidative status, oxidative and inflammatory gene expression of healthy subjects: a randomized trial.

    Science.gov (United States)

    Di Renzo, L; Merra, G; Botta, R; Gualtieri, P; Manzo, A; Perrone, M A; Mazza, M; Cascapera, S; De Lorenzo, A

    2017-04-01

    Postprandial oxidative stress is characterized by an increased susceptibility of the organism towards oxidative damage after consumption of a meal rich in lipids and/or carbohydrates. Micronutrients modulate the immune system and exert a protective action by reducing low-density lipoproteins oxidation (ox-LDL) via induction of antioxidant enzymes. The clinical study was a randomized and cross-over trial, conducted through the CONSORT flowchart. We evaluated the gene expression of 103 genes related to oxidative stress (HOSp) and human inflammasome pathways (HIp), and ox-LDL level at fasting and after 40 g raw "Tonda Gentile delle Langhe" hazelnut consumption, in association with a McDonald's® Meal (McDM) in 22 healthy human volunteers. Ox-LDL levels significantly increased comparing no dietary treatment (NDT) vs. McDM, and decreased comparing McDM vs. McDM + H (pMcDM: 3.88% HIp and 17.48% HOSp; (B) NDT vs. McDM + H: 17.48% HIp and 23.30% HOSp; (C) McDM vs. McDM + H: 17.48% HIp and 33.98% HOSp. Hazelnut consumption reduced post prandial risk factors of atherosclerosis, such as ox-LDL, and the expression of inflammation and oxidative stress related genes. Chronic studies on larger population are necessary before definitive conclusions.

  15. Effect of slump stretching versus lumbar mobilization with exercise in subjects with non-radicular low back pain: a randomized clinical trial

    Science.gov (United States)

    Nagrale, Amit Vinayak; Patil, Shubhangi Pandurang; Gandhi, Rita Amarchand; Learman, Ken

    2012-01-01

    Previous case reports, case series, and pilot studies have suggested that slump stretching may enhance the effects of spinal mobilization and stabilization exercises in patients with non-radicular low back pain (NRLBP). The purpose of this trial was to determine if slump stretching results in improvements in pain, disability, and fear and avoidance beliefs in patients with NRLBP with neural mechanosensitivity. Sixty patients, 18–60 years of age presenting with NRLBP with symptom duration >3 months, were randomized into one of two, 3-week physical therapy programs. Group one received lumbar spinal mobilization with stabilization exercises while group two received slump stretching in addition to lumbar spinal mobilization with exercise. Outcomes including the modified Oswestry disability index (ODI), numeric pain rating scale (NPRS), and the fear–avoidance belief questionnaire (FABQ) were collected at baseline, and at weeks 1, 2, 3, and 6. A doubly multivariate analysis of variance revealed a significant group–time interaction for ODI, NPRS, and FABQ. There were large within-group changes for all outcomes with Pmobilization and stabilization exercises when treating NRLBP. PMID:23372392

  16. Effect of slump stretching versus lumbar mobilization with exercise in subjects with non-radicular low back pain: a randomized clinical trial.

    Science.gov (United States)

    Nagrale, Amit Vinayak; Patil, Shubhangi Pandurang; Gandhi, Rita Amarchand; Learman, Ken

    2012-02-01

    Previous case reports, case series, and pilot studies have suggested that slump stretching may enhance the effects of spinal mobilization and stabilization exercises in patients with non-radicular low back pain (NRLBP). The purpose of this trial was to determine if slump stretching results in improvements in pain, disability, and fear and avoidance beliefs in patients with NRLBP with neural mechanosensitivity. Sixty patients, 18-60 years of age presenting with NRLBP with symptom duration >3 months, were randomized into one of two, 3-week physical therapy programs. Group one received lumbar spinal mobilization with stabilization exercises while group two received slump stretching in addition to lumbar spinal mobilization with exercise. Outcomes including the modified Oswestry disability index (ODI), numeric pain rating scale (NPRS), and the fear-avoidance belief questionnaire (FABQ) were collected at baseline, and at weeks 1, 2, 3, and 6. A doubly multivariate analysis of variance revealed a significant group-time interaction for ODI, NPRS, and FABQ. There were large within-group changes for all outcomes with Pmobilization and stabilization exercises when treating NRLBP.

  17. Cognitive and motor function after administration of hydrocodone bitartrate plus ibuprofen, ibuprofen alone, or placebo in healthy subjects with exercise-induced muscle damage: a randomized, repeated-dose, placebo-controlled study.

    Science.gov (United States)

    Allen, George J; Hartl, Tamara L; Duffany, Shannon; Smith, Stefanie F; VanHeest, Jaci L; Anderson, Jeffrey M; Hoffman, Jay R; Kraemer, William J; Maresh, Carl M

    2003-03-01

    Medications combining hydrocodone bitartrate and non-steroidal anti-inflammatory agents appear more beneficial than anti-inflammatory medications alone in treating pain and inflammation from acute soft tissue trauma, but opiate side effects may include sedation and impaired cognitive and motor performance. Performance on complex cognitive and motor tasks was evaluated in healthy subjects with exercise-induced muscle damage who were treated with a hydrocodone-ibuprofen combination, ibuprofen alone, or placebo. This double-blind, randomized, placebo-controlled, repeated-dose clinical trial compared the effects of hydrocodone bitartrate (7.5 mg) plus ibuprofen (200 mg), ibuprofen alone, and placebo on cognitive and motor function in 72 healthy college men. Muscle damage in the quadriceps of each subject's dominant leg was induced by an eccentric exercise protocol. Subjects took the study medication four times daily (every 4-6 h) for 5 days. Forty minutes after medication ingestion at the same time each day, subjects underwent tests of attention/concentration, motor performance, and reaction time. Four trained assessors rotated among subjects so that none tested the same participant on more than three occasions. Repeated measures analyses of covariance revealed no between-group differences on a complex memory and cognition task or complex reaction time. Subjects using hydrocodone bitartrate plus ibuprofen performed significantly less well on a simple tracking task and made significantly more errors on a simple reaction-time task than the other two groups. These deficits were found to be highly transitory and not related to confusion or fatigue. Hydrocodone plus ibuprofen was not associated with deterioration in complex cognition but was related to very transitory decrements in tasks involving simple hand-eye coordination.

  18. CLOCK gene variation is associated with incidence of type-2 diabetes and cardiovascular diseases in type-2 diabetic subjects: dietary modulation in the PREDIMED randomized trial.

    Science.gov (United States)

    Corella, Dolores; Asensio, Eva M; Coltell, Oscar; Sorlí, José V; Estruch, Ramón; Martínez-González, Miguel Ángel; Salas-Salvadó, Jordi; Castañer, Olga; Arós, Fernando; Lapetra, José; Serra-Majem, Lluís; Gómez-Gracia, Enrique; Ortega-Azorín, Carolina; Fiol, Miquel; Espino, Javier Díez; Díaz-López, Andrés; Fitó, Montserrat; Ros, Emilio; Ordovás, José M

    2016-01-07

    Circadian rhythms regulate key biological processes influencing metabolic pathways. Disregulation is associated with type 2 diabetes (T2D) and cardiovascular diseases (CVD). Circadian rhythms are generated by a transcriptional autoregulatory feedback loop involving core clock genes. CLOCK (circadian locomotor output cycles protein kaput), one of those core genes, is known to regulate glucose metabolism in rodent models. Cross-sectional studies in humans have reported associations between this locus and obesity, plasma glucose, hypertension and T2D prevalence, supporting its role in cardiovascular risk. However, no longitudinal study has investigated the association between CLOCK gene variation and T2D or CVD incidence. Moreover, although in a previous work we detected a gene-diet interaction between the CLOCK-rs4580704 (C > G) single nucleotide polymorphism (SNP) and monounsaturated (MUFA) intake on insulin resistance, no interventional study has analyzed gene-diet interactions on T2D or CVD outcomes. We analyzed the association between the CLOCK-rs4580704 SNP and incidence of T2D and CVD longitudinally in 7098 PREDIMED trial (ISRCTN35739639) participants after a median 4.8-year follow-up. We also examined modulation by Mediterranean diet (MedDiet) intervention (high in MUFA) on these associations. We observed a significant association between the CLOCK-rs4580704 SNP and T2D incidence in n = 3671 non-T2D PREDIMED participants, with variant allele (G) carriers showing decreased incidence (dominant model) compared with CC homozygotes (HR: 0.69; 95 % CI 0.54-0.87; P = 0.002). This protection was more significant in the MedDiet intervention group (HR: 0.58; 95 % CI 0.43-0.78; P CLOCK-rs4580704 SNP and T2D status on stroke. Thus, only in T2D subjects was CLOCK-rs4580704 SNP associated with stroke risk, G-carriers having decreased risk (HR: 0.61; 95 % CI 0.40-0.94; P = 0.024 versus CC) in the multivariable-adjusted model. In agreement with our previous results showing a

  19. Comparison of the urinary excretion of quercetin glycosides from red onion and aglycone from dietary supplements in healthy subjects: a randomized, single-blinded, cross-over study.

    Science.gov (United States)

    Shi, Yuanlu; Williamson, Gary

    2015-05-01

    Some intervention studies have shown that quercetin supplementation can regulate certain biomarkers, but it is not clear how the doses given relate to dietary quercetin (e.g. from onion). We conducted a two-period, two-sequence crossover study to compare the bioavailability of quercetin when administered in the form of a fresh red onion meal (naturally glycosylated quercetin) or dietary supplement (aglycone quercetin) under fasting conditions. Six healthy, non-smoking, adult males with BMI 22.7 ± 4.0 kg m(-2) and age 35.3 ± 12.3 y were grouped to take the two study meals in random order. In each of the 2 study periods, one serving of onion soup (made from 100 g fresh red onion, providing 156.3 ± 3.4 μmol (47 mg) quercetin) or a single dose of a quercetin dihydrate tablet (1800 ± 150 μmol (544 mg) of quercetin) were administered following 3 d washout. Urine samples were collected up to 24 h, and after enzyme deconjugation, quercetin was quantified by LC-MS. The 24 h urinary excretion of quercetin (1.69 ± 0.79 μmol) from red onion in soup was not significantly different to that (1.17 ± 0.44 μmol) for the quercetin supplement tablet (P = 0.065, paired t-test). This means that, in practice, 166 mg of quercetin supplement would be comparable to about 10 mg of quercetin aglycone equivalents from onion. These data allow intervention studies on quercetin giving either food or supplements to be more effectively compared.

  20. Acupuncture for residual insomnia associated with major depressive disorder: a placebo- and sham-controlled, subject- and assessor-blind, randomized trial.

    Science.gov (United States)

    Chung, Ka-Fai; Yeung, Wing-Fai; Yu, Yee-Man; Yung, Kam-Ping; Zhang, Shi-Ping; Zhang, Zhang-Jin; Wong, Man-Tak; Lee, Wing-King; Chan, Lai-Wah

    2015-06-01

    To evaluate the efficacy and safety of acupuncture for residual insomnia and other residual symptoms associated with major depressive disorder (MDD). 150 participants having significant insomnia for more than 3 months and a history of MDD (both based on DSM-IV-TR criteria) were recruited from 4 psychiatric outpatient clinics in Hong Kong from May 2011 to August 2013 to receive 9 sessions of treatment over 3 weeks. They were randomized to receive acupuncture, minimal acupuncture, or placebo acupuncture. Primary outcome was sleep diary-derived sleep efficiency. Secondary outcomes included other sleep diary parameters, actigraphy, anxiety and depressive symptoms, daytime functioning, and adverse events. The mean difference in sleep diary-derived sleep efficiency at 1-week posttreatment was -1.40 (95% CI, -7.08 to 4.28) between the acupuncture and minimal acupuncture groups and was 3.10 (95% CI, -3.64 to 9.84) between the acupuncture and placebo acupuncture groups. A χ(2) test showed that acupuncture produced a significantly higher proportion of participants achieving sleep-onset latency ≤ 30 minutes than did minimal acupuncture at 1-week posttreatment (P = .04). However, there was no significant between-group difference in most of the other outcomes. Treatment blinding was successful, as a majority of participants did not know which treatment they had received. Acupuncture was well tolerated, but the efficacy was only mild and similar to that of minimal acupuncture and placebo acupuncture. A high proportion of patients remained clinically significantly affected by insomnia after treatment. The finding raises certain doubts about the value of acupuncture and underscores the difficulties in the treatment of residual insomnia in MDD. ClinicalTrials.gov identifier: NCT01707706. © Copyright 2015 Physicians Postgraduate Press, Inc.

  1. Cardiovascular Safety of Oral p-Synephrine (Bitter Orange) in Healthy Subjects: A Randomized Placebo-Controlled Cross-over Clinical Trial.

    Science.gov (United States)

    Shara, Mohd; Stohs, Sidney J; Mukattash, Tareq L

    2016-05-01

    Bitter orange (Citrus aurantium) extract and its primary protoalkaloid p-synephrine are widely consumed in combination with multiple herbal ingredients for weight management and sports performance. p-Synephrine is also present in juices and foods derived from a variety of Citrus species. Questions exist regarding the safety of p-synephrine because of structural similarities with other biogenic amines. This study assessed the cardiovascular (stimulatory) effects of bitter orange extract (49-mg p-synephrine) given to 18 healthy subjects (nine men and nine women) in a double-blinded, placebo-controlled cross-over study. Heart rates, blood pressures, and electrocardiograms were determined at baseline, 30, 60, 90 min, 2, 4 , 6, and 8 h. Blood samples were drawn at baseline, 2 h and 8 h for serum chemistries, blood cell counts, and p-synephrine and caffeine levels. No significant changes occurred in electrocardiograms, heart rates, systolic blood pressure, blood chemistries, or blood cell counts at any time point in either control or p-synephrine treated group. A small (4.5 mmHg) decrease in diastolic blood pressure occurred in the p-synephrine treated group at 60 min. No adverse effects were reported. Caffeine ingestion varied markedly among the participants. p-Synephrine does not act as a stimulant at the dose used. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  2. Active Processing via Write-to-Learn Assignments: Learning and Retention Benefits in Introductory Psychology

    Science.gov (United States)

    Gingerich, Karla J.; Bugg, Julie M.; Doe, Sue R.; Rowland, Christopher A.; Richards, Tracy L.; Tompkins, Sara Anne; McDaniel, Mark A.

    2014-01-01

    This study evaluated brief, in-class write-to-learn assignments as a tool for promoting learning and retention in large, introductory psychology courses. A within-subjects (student) design was used with assignment of concepts to write-to-learn and copy (control) conditions counterbalanced across sections for each instructor. Students performed…

  3. Enhanced functional and structural domain assignments using ...

    Indian Academy of Sciences (India)

    Unknown

    biology of MTB, yet the functions of many MTB proteins are unknown. We have used sensitive profile-based search procedures to assign functional and structural domains to infer functions of gene products encoded in. MTB. These domain assignments have been made using a compendium of sequence and structural ...

  4. The Assessment of Students by Formal Assignments.

    Science.gov (United States)

    Bassey, Michael

    New Zealand universities have been examining the possibilities of abolishing end-of-year examinations and placing more importance on coursework. This monograph offers the alternative of assessing students by formal assignments. The formal assignment system has 4 essential characteristics which distinguish it from other methods of assessment. (1) A…

  5. Protein secondary structure: category assignment and predictability

    DEFF Research Database (Denmark)

    Andersen, Claus A.; Bohr, Henrik; Brunak, Søren

    2001-01-01

    structures. Single sequence prediction of the new three category assignment gives an overall prediction improvement of 3.1% and 5.1%, compared to the DSSP assignment and schemes where the helix category consists of a-helix and 3(10)-helix, respectively. These results were achieved using a standard feed-forward...

  6. Integrating Online Assignments Checking in Introductory Courses

    Science.gov (United States)

    Pundak, David; Shacham, Miri; Herscovitz, Orit

    2013-01-01

    Web technology offers lecturers the option of checking students' assignments online. Several systems have evolved to deliver personal assignments to each student in a multi-participant course. These systems provide students with immediate feedback, allowing them to correct erroneous answers and referring them to relevant literary sources that can…

  7. Assigning Elementary Pupils to Their Teachers.

    Science.gov (United States)

    Monk, David H.

    1987-01-01

    Examines variation in the methods used to assign students to classrooms and teachers in a small but highly diversified sample of elementary schools. Gives explicit attention to parental influence on pupil assignments as well as to effects of having an unusually incompetent or excellent teacher at a particular grade level. (NH)

  8. Frequency assignment for satellite multilevel SCPC systems

    Science.gov (United States)

    Lau, Yuk-Hong; Skellern, D. J.

    1991-01-01

    A method for searching the frequency assignment for satellite multilevel SCPC systems is proposed based on the method for the case of equal carrier systems. The quality of assignment improves significantly on published results. The method requires only very short computations times.

  9. Gapminder: An AP Human Geography Lab Assignment

    Science.gov (United States)

    Keller, Kenneth H.

    2012-01-01

    This lesson is designed as a lab assignment for Advanced Placement (AP) Human Geography students wherein they use the popular Gapminder web site to compare levels of development in countries from different world regions. For this lesson, it is important for the teacher to practice with Gapminder before giving the assignment to students. (Contains…

  10. Detecting Plagiarism in MS Access Assignments

    Science.gov (United States)

    Singh, Anil

    2013-01-01

    Assurance of individual effort from students in computer-based assignments is a challenge. Due to digitization, students can easily use a copy of their friend's work and submit it as their own. Plagiarism in assignments puts students who cheat at par with those who work honestly and this compromises the learning evaluation process. Using a…

  11. Postgraduate diploma collaborative assignment: Implications for ...

    African Journals Online (AJOL)

    Business groups remained intact across various diplomas and large focus areas, which would act as a pivot for the major group assignments, were forged using scenarios from three core courses. Each general topic thus included at least three separate yet complementary portfolio assignments that differed in genre, ...

  12. A placebo-controlled, double-blind, randomized, multicenter study to assess the effects of dronedarone 400 mg twice daily for 12 weeks on atrial fibrillation burden in subjects with permanent pacemakers.

    Science.gov (United States)

    Ezekowitz, Michael D; Ellenbogen, Kenneth A; DiMarco, John P; Kaszala, Karoly; Boddy, Alexander; Geba, Gregory P; P, Gregory Geba; Koren, Andrew

    2015-03-01

    Dronedarone is a benzofuran derivative with a pharmacological profile similar to amiodarone but has a more rapid onset of action and a much shorter half-life (13-19 h). Our goal was to evaluate the efficacy of dronedarone in atrial fibrillation (AF) patients using dual-chamber pacemakers capable of quantifying atrial fibrillation burden. Pacemakers were adjusted to optimize AF detection. Patients with AF burden >1% were randomized to dronedarone 400 mg twice daily (BID) or placebo. Pacemakers were interrogated after 4 and 12 weeks of treatment. The primary endpoint was the change in AF burden from baseline over the 12-week treatment period. Patients with permanent AF, severe/recently decompensated heart failure, and current use of antiarrhythmic drugs were excluded. AF burden was assessed by a core laboratory blinded to treatment assignment. From 285 patients screened, 112 were randomized (mean age 76 years, 60% male, 84% hypertensive, 65% with sick sinus syndrome, 26% with diabetes mellitus type II, 15% with heart failure). Baseline mean (SEM) AF burden was 8.77% (0.16) for placebo and 10.14% (0.17) for dronedarone. Over the 12-week study period, AF burden compared to baseline decreased by 54.4% (0.22) (P = 0.0009) with dronedarone and trended higher by 12.8% (0.16) (P = 0.450) with placebo. The absolute change in burden was decreased by 5.5% in the dronedarone group and increased by 1.1% in the placebo group. Heart rate during AF was reduced to approximately 4 beats/min with dronedarone (P = 0.285). Adverse events were higher with dronedarone compared to placebo (65 vs 56%). Dronedarone reduced pacemaker-assessed the relative AF burden compared to baseline and placebo by over 50% during the 12-week observation period.

  13. Effect of ezetimibe add-on therapy over 52 weeks extension analysis of prospective randomized trial (RESEARCH study) in type 2 diabetes subjects.

    Science.gov (United States)

    Sakamoto, Kentaro; Kawamura, Mitsunobu; Watanabe, Takayuki; Ashidate, Keiko; Kohro, Takahide; Tanaka, Akira; Mori, Yasumichi; Tagami, Motoki; Hirano, Tsutomu; Yamazaki, Tsutomu; Shiba, Teruo

    2017-06-24

    Lowering cholesterol levels decreases the risk of atherosclerotic diseases. Effective ways to stably reduce LDL-C level are warranted in type 2 diabetic patients, a high-risk population for CVD, with various anti-diabetic therapeutic background. The RESEARCH study focuses on LDL-C reduction in this population along with modifications of the lipid profiles. We evaluated long-term ezetimibe add-on therapy in T2DM patients with hypercholesterolemia. In a randomized, multicenter, open-label, prospective study, a total of 109 T2DM patients not attaining LDL-C target value despite first-line dose statin (10 mg of atorvastatin or 1 mg of pitavastatin) therapy in Japan were recruited. We investigated the difference in cholesterol lowering effect between ezetimibe (10 mg) add-on statin (EAT) group and double-dose statin (DST) group. Changes of parameters related to atherosclerotic event risks were assessed. The reduction of LDL-C was larger in the EAT group (28.3%) than in the DST group (9.2%) at 52 weeks as well as the primary endpoint of 12 weeks. EAT achieved significant lower levels of TC and apo B, respectively. Both treatments attained significant reduction in sd-LDL-C or hsCRP on this long-term basis. Notably, sd-LDL-C in EAT reduced as low as 36.1 ± 14.9 mg/dl to reach near the threshold (35.0 mg/dl) for atherosclerosis with significantly higher achievement rate (55.6%) than DST treatment. Simultaneously, hsCRP reduction by EAT attained as low value as 0.52 ± 0.43 mg/l. In the present 52-week long-term period, ezetimibe add-on therapy showed a robust advantage in lowering LDL-C and in attaining target LDL-C values compared with the doubling of statin dose. Moreover, it's meaningful that sd-LDL, powerfully atherogenic lipoprotein, exhibited prominent decrease consistently prominently by ezetimibe add-on therapy. DM patients with hypercholesterolemia are at high risk for CAD, and adding ezetimibe onto usual-dose statin treatment in Japan has been

  14. The effects of the mediterranean diet on biomarkers of vascular wall inflammation and plaque vulnerability in subjects with high risk for cardiovascular disease. A randomized trial.

    Directory of Open Access Journals (Sweden)

    Rosa Casas

    Full Text Available BACKGROUND: Adherence to the Mediterranean diet (MD is associated with reduced morbidity and mortality due to cardiovascular disease. However, how the MD exerts its effects is not fully known. AIM: To assess the 12-month effects of two enhanced MDs compared to a low-fat diet on inflammatory biomarkers related to atherosclerosis and plaque vulnerability in a subcohort of the PREDIMED (Prevención con Dieta Mediterránea study. METHODS: A total of 164 participants at high risk for cardiovascular disease were randomized into three diet groups: MD supplemented with 50mL/d of extra virgin olive oil (MD+EVOO or 30 g/d of nuts (MD+Nuts and a low-fat diet. Changes in classical cardiovascular risk factors, inflammatory biomarkers of atherosclerosis and plaque vulnerability were measured after 12 months of intervention. RESULTS: Compared to participants in the low-fat diet group, those receiving MD+EVOO and MD+Nuts showed a higher decrease in systolic (6mmHg and diastolic (3mmHg blood pressure (P = 0.02; both, as well as a reduction of 10% and 8% in LDL-cholesterol (P = 0.04, respectively. Patients in the MD+Nuts group showed a significant reduction of 34% in CD40 expression on monocyte surface compared to low-fat diet patients (P = 0.03. In addition, inflammatory biomarkers related to plaque instability such as C-reactive protein and interleukin-6 were reduced by 45% and 35% and 95% and 90% in the MD+EVOO and MD+Nuts groups, respectively (P<0.05; all compared to the low-fat diet group. Likewise, sICAM and P-selectin were also reduced by 50% and 27%, respectively in the MD+EVOO group (P = 0.04 and P-selectin by 19% in MD+Nuts group (P = 0.04 compared to the low-fat diet group. CONCLUSIONS: Adherence to the MD is associated with an increase in serum markers of atheroma plaque stability which may explain, at least in part, the protective role of MD against ischemic heart disease. TRIAL REGISTRATION: www.controlled-trials.com ISRCTN

  15. The Effects of the Mediterranean Diet on Biomarkers of Vascular Wall Inflammation and Plaque Vulnerability in Subjects with High Risk for Cardiovascular Disease. A Randomized Trial

    Science.gov (United States)

    Casas, Rosa; Sacanella, Emilio; Urpí-Sardà, Mireia; Chiva-Blanch, Gemma; Ros, Emilio; Martínez-González, Miguel-Angel; Covas, Maria-Isabel; Salas-Salvadó, Jordi; Fiol, Miquel; Arós, Fernando; Estruch, Ramon

    2014-01-01

    Background Adherence to the Mediterranean diet (MD) is associated with reduced morbidity and mortality due to cardiovascular disease. However, how the MD exerts its effects is not fully known. Aim To assess the 12-month effects of two enhanced MDs compared to a low-fat diet on inflammatory biomarkers related to atherosclerosis and plaque vulnerability in a subcohort of the PREDIMED (Prevención con Dieta Mediterránea) study. Methods A total of 164 participants at high risk for cardiovascular disease were randomized into three diet groups: MD supplemented with 50mL/d of extra virgin olive oil (MD+EVOO) or 30 g/d of nuts (MD+Nuts) and a low-fat diet. Changes in classical cardiovascular risk factors, inflammatory biomarkers of atherosclerosis and plaque vulnerability were measured after 12 months of intervention. Results Compared to participants in the low-fat diet group, those receiving MD+EVOO and MD+Nuts showed a higher decrease in systolic (6mmHg) and diastolic (3mmHg) blood pressure (P = 0.02; both), as well as a reduction of 10% and 8% in LDL-cholesterol (P = 0.04), respectively. Patients in the MD+Nuts group showed a significant reduction of 34% in CD40 expression on monocyte surface compared to low-fat diet patients (P = 0.03). In addition, inflammatory biomarkers related to plaque instability such as C-reactive protein and interleukin-6 were reduced by 45% and 35% and 95% and 90% in the MD+EVOO and MD+Nuts groups, respectively (P<0.05; all) compared to the low-fat diet group. Likewise, sICAM and P-selectin were also reduced by 50% and 27%, respectively in the MD+EVOO group (P = 0.04) and P-selectin by 19% in MD+Nuts group (P = 0.04) compared to the low-fat diet group. Conclusions Adherence to the MD is associated with an increase in serum markers of atheroma plaque stability which may explain, at least in part, the protective role of MD against ischemic heart disease. Trial Registration www.controlled-trials.com ISRCTN35739639 PMID

  16. On the Bicriterion Multi Modal Assignment Problem

    DEFF Research Database (Denmark)

    Pedersen, Christian Roed; Nielsen, L.R.; Andersen, K.A.

    2005-01-01

    We consider the bicriterion multi modal assignment problem which is a new generalization of the classical linear assignment problem. A two-phase solution method using an effective ranking scheme is presented. The algorithm is valid for generating all nondominated criterion points or an approximat......We consider the bicriterion multi modal assignment problem which is a new generalization of the classical linear assignment problem. A two-phase solution method using an effective ranking scheme is presented. The algorithm is valid for generating all nondominated criterion points...... or an approximation. Extensive computational results are conducted on a large library of test instances to test the performance of the algorithm and to identify hard test instances. Also, test results of the algorithm applied to the bicriterion assignment problem is given. Here our algorithm outperforms all...

  17. Blocked Randomization with Randomly Selected Block Sizes

    Directory of Open Access Journals (Sweden)

    Jimmy Efird

    2010-12-01

    Full Text Available When planning a randomized clinical trial, careful consideration must be given to how participants are selected for various arms of a study. Selection and accidental bias may occur when participants are not assigned to study groups with equal probability. A simple random allocation scheme is a process by which each participant has equal likelihood of being assigned to treatment versus referent groups. However, by chance an unequal number of individuals may be assigned to each arm of the study and thus decrease the power to detect statistically significant differences between groups. Block randomization is a commonly used technique in clinical trial design to reduce bias and achieve balance in the allocation of participants to treatment arms, especially when the sample size is small. This method increases the probability that each arm will contain an equal number of individuals by sequencing participant assignments by block. Yet still, the allocation process may be predictable, for example, when the investigator is not blind and the block size is fixed. This paper provides an overview of blocked randomization and illustrates how to avoid selection bias by using random block sizes.

  18. Blocked randomization with randomly selected block sizes.

    Science.gov (United States)

    Efird, Jimmy

    2011-01-01

    When planning a randomized clinical trial, careful consideration must be given to how participants are selected for various arms of a study. Selection and accidental bias may occur when participants are not assigned to study groups with equal probability. A simple random allocation scheme is a process by which each participant has equal likelihood of being assigned to treatment versus referent groups. However, by chance an unequal number of individuals may be assigned to each arm of the study and thus decrease the power to detect statistically significant differences between groups. Block randomization is a commonly used technique in clinical trial design to reduce bias and achieve balance in the allocation of participants to treatment arms, especially when the sample size is small. This method increases the probability that each arm will contain an equal number of individuals by sequencing participant assignments by block. Yet still, the allocation process may be predictable, for example, when the investigator is not blind and the block size is fixed. This paper provides an overview of blocked randomization and illustrates how to avoid selection bias by using random block sizes.

  19. Effects of a Combined Nutraceutical on Lipid Pattern, Glucose Metabolism and Inflammatory Parameters in Moderately Hypercholesterolemic Subjects: A Double-blind, Cross-over, Randomized Clinical Trial.

    Science.gov (United States)

    Cicero, Arrigo Francesco Giuseppe; Colletti, Alessandro; Fogacci, Federica; Bove, Marilisa; Rosticci, Martina; Borghi, Claudio

    2017-03-01

    There is an increasing interest for combined nutraceuticals that can act on several points of lipid and glucose metabolism with preventive purposes. However, the simple assemblage of nutraceuticals with potentially additive mechanism of action need to be clinically tested. To assess the effects of a combination of nutraceuticals based on artichoke, red yeast rice, banaba, and coenzyme Q10, we performed a double bind, cross-over designed trial versus placebo in 30 adults with LDL cholesterol suboptimal in primary prevention of cardiovascular disease. After a period of 3 weeks of dietary habits correction, patients began a period of 6 weeks of treatment with nutraceutical or placebo, followed by 2 weeks of washout and finally 6 weeks in cross-over. Data related to lipid pattern, insulin resistance, renal function, liver and CPK have been obtained at each visit. In particular, the after the nutraceutical treatment the enrolled patients experienced a significant improvement in total cholesterol (-13.6 %), LDL-C (-18.2 %), non-HDL-C (-15 %), glutamic oxaloacetic transaminase (-10 %), glutamate-pyruvate transaminase (-30.9 %), and hs-CRP (-18.2 %) versus placebo. No changes have been observed in the other investigated parameters in both groups. The tested combination of nutraceuticals has shown clinical efficacy in the reduction of total cholesterol, non-HDL, LDL and triglycerides, while improving the level of liver transaminases and high sensitivity C-reactive protein. Further confirmation are needed to verify these observations on the middle and long term with a larger number of subjects.

  20. Randomized placebo-controlled study of the safety, tolerability, antiviral activity, and pharmacokinetics of 10-day monotherapy with BMS-986001, a novel HIV NRTI, in treatment-experienced HIV-1-infected subjects.

    Science.gov (United States)

    Cotte, Laurent; Dellamonica, Pierre; Raffi, Francois; Yazdanpanah, Yazdan; Molina, Jean-Michel; Boué, François; Urata, Yasuo; Chan, H Phyllis; Zhu, Li; Chang, Ih; Bertz, Richard; Hanna, George J; Grasela, Dennis M; Hwang, Carey

    2013-07-01

    To investigate the safety, tolerability, pharmacokinetics, and antiviral activity of BMS-986001 (a nucleoside reverse transcriptase inhibitor) in treatment-experienced, HIV-1-infected subjects not exposed to antiretroviral treatment in the previous 3 months. Thirty-two HIV-1-infected subjects were randomized (3:1) to receive BMS-986001 or placebo once daily for 10 days in this double-blind, placebo-controlled, dose-escalating monotherapy phase IIa study. There were 4 treatment groups (100, 200, 300, and 600 mg, all once daily) of 8 subjects each (BMS-986001, n = 6/placebo n = 2). BMS-986001 was generally well tolerated, with no discontinuations due to adverse events and no deaths occurring. Adverse events were experienced by 22 of 24 BMS-986001-treated subjects and did not seem to be dose related. The majority were mild and considered unrelated or unlikely to be related to the study drug. The pharmacokinetics of BMS-986001 were dose proportional. Median decrease in plasma HIV-1 RNA from baseline to day 11 was 0.97, 1.15, 1.28, and 1.15 log10 copies/mL for BMS-986001 at 100, 200, 300, and 600 mg, respectively. Plasma area under the curve correlated with the antiviral activity of BMS-986001, indicating that area under the curves produced by 100-600 mg doses were on the upper end of the exposure-response curve. One subject with a single thymidine analog mutation at baseline responded well to BMS-986001. Administration of BMS-986001 for 10 days resulted in substantial decreases in plasma HIV-1 RNA levels for all dose groups and was generally well tolerated. These data support continued clinical development of BMS-986001 at a dose of 100 mg, once daily or greater. EUDRACT Number 2008-004810-29.

  1. Efficacy of a 3-month lifestyle intervention program using a Japanese-style healthy plate on body weight in overweight and obese diabetic Japanese subjects: a randomized controlled trial.

    Science.gov (United States)

    Yamauchi, Keiko; Katayama, Tomomi; Yamauchi, Takahiro; Kotani, Kazuhiko; Tsuzaki, Kokoro; Takahashi, Kaoru; Sakane, Naoki

    2014-11-24

    The portion size of food is a determinant of energy intake, linking with obese traits. A healthy plate for portion control has recently been made in a Japanese style. The aim of the current study was to assess the efficacy of a lifestyle intervention program using the Japanese-style healthy plate on weight reduction in overweight and obese diabetic Japanese subjects. We randomized overweight and obese diabetic subjects (n = 19, 10 women) into an intervention group including educational classes on lifestyle modification incorporating the healthy plate (n = 10) or a waiting-list control group (n = 9). The intervention period was three months, and the educational classes using the healthy plate were conducted monthly in a group session for the intervention group. The body weight, blood glycemic and metabolic measures, and psychosocial variables were measured at the baseline and after the 3-month intervention in both groups. The impression of the intervention was interviewed using a structured questionnaire. There was one drop-out in the control group. No adverse events were reported in the groups. Subjects in the intervention group had a greater weight change from baseline to the end of the 3-month intervention period (-3.7 +/- 2.5 [SD] kg in the intervention group vs. -0.1 +/- 1.4 kg in the control group, P = 0.002). Most subjects recorded that the use of a healthy plate could be recommended to other people. The lifestyle intervention program using the Japanese-style healthy plate, which was developed for portion control, may effectively reduce body weight in overweight and obese diabetic subjects in Japan. Further studies are needed to establish the efficacy of this methodology on weight management.

  2. A randomized, rater-blinded, crossover study of the effects of oxymorphone extended release, fed versus fasting, on cognitive performance as tested with CANTAB in opioid-tolerant subjects.

    Science.gov (United States)

    Spierings, Egilius L H; Volkerts, Edmund R; Heitland, Ivo; Thomson, Heather

    2014-02-01

    The maximum plasma concentration (Cmax ) of oxymorphone extended release (ER) 20 mg and 40 mg is approximately 50% higher in fed than in fasted subjects, with most of the difference in area-under-the-curve (AUC) occurring in the first 4 hours post-dose. Hence, the US FDA recommends in the approved labeling that oxymorphone ER is taken at least 1 hour before or 2 hours after eating. In order to determine the potential impact on cognitive performance of the increased absorption of oxymorphone ER, fed versus fasting, we conducted a randomized, rater-blinded, crossover study in 30 opioid-tolerant subjects, using tests from the Cambridge Neuropsychological Test Automated Battery (CANTAB). The subjects randomly received 40 mg oxymorphone ER after a high-fat meal of approximately 1,010 kCal or after fasting for 8-12 hours, and were tested 1 hour and 3 hours post-dose. The CANTAB tests, Spatial Recognition Memory (SRM) and Spatial Working Memory (SWM), showed no statistically significant differences between the fed and fasting conditions. However, sustained attention, as measured by the Rapid Visual Information Processing (RVP) CANTAB test, showed a statistically significant interaction of fed versus fasting and post-dose time of testing (F[1,28] = 6.88, P = 0.01), suggesting that 40 mg oxymorphone ER after a high-fat meal versus fasting mitigates the learning effect in this particular cognition domain from 1 hour to 3 hours post-dose. Oxymorphone 40 mg ER affected cognitive performance similarly within 3 hours post-dose, whether given on an empty stomach or after a high-fat meal, suggesting that the effect of food on plasma concentration may not be relevant in the medication's impact on cognition. Wiley Periodicals, Inc.

  3. Association of efavirenz hypersusceptibility with virologic response in ACTG 368, a randomized trial of abacavir (ABC) in combination with efavirenz (EFV) and indinavir (IDV) in HIV-infected subjects with prior nucleoside analog experience.

    Science.gov (United States)

    Demeter, Lisa M; DeGruttola, Victor; Lustgarten, Stephanie; Bettendorf, Daniel; Fischl, Margaret; Eshleman, Susan; Spreen, William; Nguyen, Bach-Yen; Koval, Christine E; Eron, Joseph J; Hammer, Scott; Squires, Kathleen

    2008-01-01

    To evaluate the association of efavirenz hypersusceptibility (EFV-HS) with clinical outcome in a double-blind, placebo-controlled, randomized trial of EFV plus indinavir (EFV+IDV) vs. EFV+IDV plus abacavir (ABC) in 283 nucleoside-experienced HIV-infected patients. Rates of virologic failure were similar in the 2 arms at week 16 (p = .509). Treatment discontinuations were more common in the ABC arm (p = .001). Using logistic regression, there was no association between virologic failure and either baseline ABC resistance or regimen sensitivity score. Using 3 different genotypic scoring systems, EFV-HS was significantly associated with reduced virologic failure at week 16, independent of treatment assignment. In some patients on the nucleoside-sparing arm, the nucleoside-resistance mutation L74V was selected for in combination with the uncommonly occurring EFV-resistance mutations K103N+L100I; L74V was not detected as a minority variant, using clonal sequence analysis, when the nucleoside-sparing regimen was initiated. Premature treatment discontinuations in the ABC arm and the presence of EFV-HS HIV variants in this patient population likely made it difficult to detect a benefit of adding ABC to EFV+IDV. In addition, L74V, when combined with K103N+L100I, may confer a selective advantage to the virus that is independent of its effects on nucleoside resistance.

  4. Neurocognitive performance, subjective well-being, and psychosocial functioning after benzodiazepine withdrawal in patients with schizophrenia or bipolar disorder: a randomized clinical trial of add-on melatonin versus placebo.

    Science.gov (United States)

    Baandrup, Lone; Fagerlund, Birgitte; Glenthoj, Birte

    2017-03-01

    Chronic benzodiazepine use is common in patients with mental illness and is associated with cognitive impairment. It is unclear whether benzodiazepine-induced cognitive impairment is reversible. Amelioration of cognitive dysfunction may be facilitated during benzodiazepine tapering by add-on melatonin due to its anti-inflammatory and neuroprotective properties. We examined how melatonin and benzodiazepine withdrawal affect cognition, subjective well-being, and psychosocial functioning. Eighty patients with schizophrenia or bipolar disorder were randomized to add-on treatment once daily with either prolonged-release melatonin or placebo in a 24-week, double-blind clinical trial. All participants gradually tapered usual benzodiazepine dosage in a closely monitored treatment setting. We used the Brief Assessment of Cognition in Schizophrenia (BACS) to assess neurocognitive performance with additional assessments of subjective well-being and psychosocial functioning. BACS composite and subscale scores (except motor speed) significantly improved in parallel with benzodiazepine dose reduction, but there was no additional effect of melatonin. Cognitive performance was still markedly impaired post-tapering compared with normative data. Neither benzodiazepine withdrawal nor treatment group affected subjective well-being or psychosocial functioning. In conclusion, add-on melatonin does not seem to affect cognition, well-being, or psychosocial functioning in patients with severe mental illness. The observed improvement in cognitive performance could not be distinguished from retest effects, which may in turn have been facilitated by the benzodiazepine tapering.

  5. Yeast (1,3)-(1,6)-beta-glucan helps to maintain the body's defence against pathogens: a double-blind, randomized, placebo-controlled, multicentric study in healthy subjects.

    Science.gov (United States)

    Auinger, Annegret; Riede, Linda; Bothe, Gordana; Busch, Regina; Gruenwald, Joerg

    2013-12-01

    The effect of brewers' yeast (1,3)-(1,6)-beta-D-glucan consumption on the number of common cold episodes in healthy subject was investigated. In a placebo-controlled, double-blind, randomized, multicentric clinical trial, 162 healthy participants with recurring infections received 900 mg of either placebo (n = 81) or an insoluble yeast (1,3)-(1,6)-beta-D-glucan preparation (n = 81) per day over a course of 16 weeks. Subjects were instructed to document each occurring common cold episode in a diary and to rate ten predefined infection symptoms during an infections period, resulting in a symptom score. The subjects were examined by the investigator during the episode visit on the 5th day of each cold episode. In the per protocol population, supplementation with insoluble yeast (1,3)-(1,6)-beta-glucan reduced the number of symptomatic common cold infections by 25% as compared to placebo (p = 0.041). The mean symptom score was 15% lower in the beta-glucan as opposed to the placebo group (p = 0.125). Beta-glucan significantly reduced sleep difficulties caused by cold episode as compared to placebo (p = 0.028). Efficacy of yeast beta-glucan was rated better than the placebo both by physicians (p = 0.004) participants (p = 0.012). The present study demonstrated that yeast beta-glucan preparation increased the body's potential to defend against invading pathogens.

  6. A randomized, crossover, placebo- and moxifloxacin-controlled study to evaluate the effects of bosutinib (SKI-606), a dual Src/Abl tyrosine kinase inhibitor, on cardiac repolarization in healthy adult subjects.

    Science.gov (United States)

    Abbas, Richat; Hug, Bruce A; Leister, Cathie; Sonnichsen, Daryl

    2012-08-01

    Effects of therapeutic and supratherapeutic concentrations of bosutinib, a dual Src/Abl tyrosine kinase inhibitor, on the corrected QT interval (QTc) in 60 healthy adults were assessed, according to ICH-E14 guidelines, in this 2-part, randomized, single-dose, double-blind, crossover, placebo- and open-label moxifloxacin-controlled study. Subjects received placebo, moxifloxacin and bosutinib 500 mg with food (therapeutic) in Part 1. In Part 2, subjects received placebo and bosutinib 500 mg plus ketoconazole (supratherapeutic). ANOVA compared baseline-adjusted QTc for bosutinib with placebo; and bosutinib plus ketoconazole with placebo plus ketoconazole. Primary endpoint was population-specific QT correction (QTcN). Secondary endpoints were Bazett QT correction (QTcB), Fridericia's formula QT correction (QTcF) and individual QT correction (QTcI). Upper bounds for 90% confidence intervals were bosutinib concentrations and QTc. No subjects had QTcB, QTcF, QTcI or QTcN >450 msec or change from baseline >30 msec. In summary, therapeutic and supratherapeutic bosutinib exposures are not associated with QTc prolongation in healthy adults. Copyright © 2011 UICC.

  7. Efficacy of yogurt drink with added plant stanol esters (Benecol®, Colanta) in reducing total and LDL cholesterol in subjects with moderate hypercholesterolemia: a randomized placebo-controlled crossover trial NCT01461798.

    Science.gov (United States)

    Vásquez-Trespalacios, Elsa M; Romero-Palacio, Johanna

    2014-08-06

    Cardiovascular diseases have become the leading cause of death from chronic diseases in the world. Main risk factors include hypercholesterolemia, which is caused in most cases by a high saturated fat diet. Plant stanol esters partly block cholesterol absorption in the digestive tract and thereby reduce total cholesterol and low-density lipoprotein (LDL) cholesterol serum levels. Based on epidemiological data, a 10 percent reduction of LDL cholesterol leads to a 20 percent decrease in the coronary heart disease risk throughout life. The aim of this study was to evaluate the efficacy of yogurt drink with added plant stanol esters (Benecol® yogurt drink) in higher doses than the typically used (2g/d stanols), in lowering blood lipids in moderately hypercholesterolemic subjects. A randomized double-blind crossover, placebo-controlled study in moderately hypercholesterolemic subjects (n = 40) aged between 20 and 50 years old. Yogurt drink with added plant stanols (4 g) as esters (Benecol®, Colanta) consumption compared to regular yogurt drink caused a statistically significant decrease in total cholesterol and low density lipoprotein cholesterol by 7.2% and 10.3%. During the two periods and compared to controls, high-density lipoprotein cholesterol and triglycerides were not significantly different. Yogurt drink with an active ingredient in Benecol®, plant stanol esters, reduced total cholesterol and LDL cholesterol in moderately hypercholesterolemic subjects. NCT01461798.

  8. Expanding subjectivities

    DEFF Research Database (Denmark)

    Lundgaard Andersen, Linda; Soldz, Stephen

    2012-01-01

    A major theme in recent psychoanalytic thinking concerns the use of therapist subjectivity, especially “countertransference,” in understanding patients. This thinking converges with and expands developments in qualitative research regarding the use of researcher subjectivity as a tool to understa...

  9. Towards Next Generation Rubrics: An Automated Assignment Feedback System

    Directory of Open Access Journals (Sweden)

    Nilupulee Nathawitharana

    2017-11-01

    Full Text Available As the use of blended learning environments and digital technologies become integrated into the higher education sector, rich technologies such as analytics have shown promise in facilitating teaching and learning. One popular application of analytics is Automated Writing Evaluation (AWE systems. Such systems can be used in a formative way; for example, by providing students with feedback on digitally submitted assignments. This paper presents work on the development of an AWE software tool for an Australian university using advanced text analytics techniques. The tool was designed to provide students with timely feedback on their initial assignment drafts, for revision and further improvement. Moreover, it could also assist academics in better understanding students’ assignment performance so as to inform future teaching activities. The paper provides details on the methodology used for development of the software, and presents the results obtained from the analysis of text-based assignments submitted in two subjects. The results are discussed, highlighting how the tool can provide practical value, followed by insights into existing challenges and possible future directions.

  10. The Assignment Game : The Reduced Game

    OpenAIRE

    Guillermo OWEN

    1992-01-01

    Let v be an assignment game. For a given reference payoff vector (x; y), and a coalition S, bargaining within the coalition can be represented by either the reduced game or the derived game. It is known that the reduced game need not be an assignment game (in fact, it need not be super additive) while the derived game is another assignment game, with modified reservation prices. We prove that, when the reference vector is in the core of the game, the derived game is the super additive cover o...

  11. Persuasive Effects of Linguistic Agency Assignments and Point of View in Narrative Health Messages About Colon Cancer.

    Science.gov (United States)

    Chen, Meng; McGlone, Matthew S; Bell, Robert A

    2015-08-01

    The authors explored the effects of linguistic agency and point of view on narrative force. Participants (N = 499) were randomly assigned to read one version of an article about colon cancer, defined by a 2 (disease agency: cancer, human) × 2 (temporal agency: death, human) × 2 (point of view: first person, third person) between-subjects design. Disease agency language assigned agency to cancer (e.g., "Cancer developed in me") or to humans (e.g., "I developed cancer"). Temporal agency language described death as approaching humans (e.g., "as death closes in on patients) or as being approached by humans (e.g., "as patients close in on death"). The narrative was presented from the first-person singular or third-person plural viewpoint. Participants then completed a questionnaire measuring threat perceptions, efficacy, transportation, and other study variables. Language assigning agency to humans rather than to cancer elevated susceptibility beliefs. Death-approach language led to greater fear than human-approach language without impacting efficacy perceptions. Human-approach language was rated more persuasive than death-approach language, but only in first-person point-of-view narratives. Transportation and identification were positively associated with ratings of threat severity and susceptibility, fear, efficacy, behavioral intentions, and message persuasiveness. Implications for message design are discussed.

  12. Effectiveness of Telemonitoring in Patients with Chronic Obstructive Pulmonary Disease in Taiwan-A Randomized Controlled Trial

    OpenAIRE

    Te-Wei Ho; Chun-Ta Huang; Herng-Chia Chiu; Sheng-Yuan Ruan; Yi-Ju Tsai; Chong-Jen Yu; Feipei Lai

    2016-01-01

    Chronic obstructive pulmonary disease (COPD) is the leading cause of death worldwide, and poses a substantial economic and social burden. Telemonitoring has been proposed as a solution to this growing problem, but its impact on patient outcome is equivocal. This randomized controlled trial aimed to investigate effectiveness of telemonitoring in improving COPD patient outcome. In total, 106 subjects were randomly assigned to the telemonitoring (n?=?53) or usual care (n?=?53) group. During the ...

  13. Auditing the Assignments of Top-Level Semantic Types in the UMLS Semantic Network to UMLS Concepts.

    Science.gov (United States)

    He, Zhe; Perl, Yehoshua; Elhanan, Gai; Chen, Yan; Geller, James; Bian, Jiang

    2017-11-01

    The Unified Medical Language System (UMLS) is an important terminological system. By the policy of its curators, each concept of the UMLS should be assigned the most specific Semantic Types (STs) in the UMLS Semantic Network (SN). Hence, the Semantic Types of most UMLS concepts are assigned at or near the bottom (leaves) of the UMLS Semantic Network. While most ST assignments are correct, some errors do occur. Therefore, Quality Assurance efforts of UMLS curators for ST assignments should concentrate on automatically detected sets of UMLS concepts with higher error rates than random sets. In this paper, we investigate the assignments of top-level semantic types in the UMLS semantic network to concepts, identify potential erroneous assignments, define four categories of errors, and thus provide assistance to curators of the UMLS to avoid these assignments errors. Human experts analyzed samples of concepts assigned 10 of the top-level semantic types and categorized the erroneous ST assignments into these four logical categories. Two thirds of the concepts assigned these 10 top-level semantic types are erroneous. Our results demonstrate that reviewing top-level semantic type assignments to concepts provides an effective way for UMLS quality assurance, comparing to reviewing a random selection of semantic type assignments.

  14. Dynamic traffic assignment : genetic algorithms approach

    Science.gov (United States)

    1997-01-01

    Real-time route guidance is a promising approach to alleviating congestion on the nations highways. A dynamic traffic assignment model is central to the development of guidance strategies. The artificial intelligence technique of genetic algorithm...

  15. Homework assignments in couple and family therapy.

    Science.gov (United States)

    Dattilio, Frank M

    2002-05-01

    Homework has been cited as an integral part of a number of theoretical orientations and therapy formats; unfortunately, very little has been written about its use with couples and families. This is despite the fact that many couple and family therapists espouse the use of homework or out-of-session assignments in order to help the effects of therapy jell. This article reviews some of the empirical literature on homework assignments and their effectiveness in the domain of therapy for families and couples. It also highlights the effectiveness of and the need for out-of-session assignments in treatment. A case illustration is used to demonstrate how homework assignments may be used as a significant change agent in couple and family treatment. Copyright 2002 Wiley Periodicals, Inc.

  16. A comparison of the efficacy, safety, and longevity of two different hyaluronic acid dermal fillers in the treatment of severe nasolabial folds: a multicenter, prospective, randomized, controlled, single-blind, within-subject study

    Directory of Open Access Journals (Sweden)

    Rogers JD

    2011-12-01

    Full Text Available Greg J Goodman1, Phillip Bekhor2, Michael Rich3, Robert H Rosen4, Michael B Halstead5, John D Rogers51Dermatology Institute of Victoria, South Yarra, Victoria, Australia; 2Laser Dermatology, Box Hill, Victoria, Australia; 3enRich Dermatology and Cosmetic Surgery Centre, Armadale, Victoria, Australia; 4Southderm Pty Ltd, Kogarah, New South Wales, Australia; 5Allergan Australia, Gordon, New South Wales, AustraliaBackground: Commercially available hyaluronic acid (HA-based fillers have distinct physicochemical properties related to their specific manufacturing technology, including HA concentration, cross-linking percentage, and particle size. These factors may determine treatment effectiveness, safety, and longevity; however, this requires confirmation in the clinic.Methods: To compare the efficacy, safety, and longevity of two distinct HA-based dermal fillers in the correction of severe nasolabial folds (NLFs, a 24 mg/mL smooth gel (Juvederm ULTRA PLUS™ [JUP] and a 20 mg/mL particulate gel (Perlane® [PER] were injected in a total of 80 normal, healthy subjects using a split face design and were followed for 12 months in this prospective, randomized, controlled, multicenter study.Results: Both fillers achieved a clinically relevant NLF correction (one point or more improvement, based on a validated NLF severity scale. However, JUP displayed greater longevity, with this correction maintained in a significantly larger percentage of NLFs after 6 months (physician's evaluation or 9 months (subject's evaluation and thereafter for the remainder of the study (70% vs 45%; P = 0.0002 and 62.5% vs 46.3%; P = 0.01 at month 12, based on physician and subject assessments, respectively. At month 12, 71.4% of the subjects nominated a preference for the NLF injected with JUP (P < 0.0001. Both treatments were well tolerated.Conclusion: These results suggest that different physicochemical properties of HA-based fillers, associated with distinct manufacturing

  17. Economic benefit assignment in environmental cost allocation

    OpenAIRE

    Collins C. Ngwakwe

    2013-01-01

    This paper aims to suggest a model to reward a dirty product which has the potential to offer sales promotion services to other clean products in a multiple product firm. The paper suggests a model economic benefit assignment (eba) for apportionment of direct waste costs where a polluting product offers a sales promotion benefit to other clean products of the same company, which proposes that benefiting products should be assigned a proportion of the direct waste cost of the polluting product...

  18. Effect of a short-term dietary supplementation with phytosterols, red yeast rice or both on lipid pattern in moderately hypercholesterolemic subjects: a three-arm, double-blind, randomized clinical trial.

    Science.gov (United States)

    Cicero, Arrigo F G; Fogacci, Federica; Rosticci, Martina; Parini, Angelo; Giovannini, Marina; Veronesi, Maddalena; D'Addato, Sergio; Borghi, Claudio

    2017-01-01

    Phytosterols and red yeast rice are largely studied cholesterol-lowering nutraceuticals, respectively inhibiting the bowel absorption and liver synthesis of cholesterol. Our aim was to test the effect on lipid profile of phytosterols, red yeast rice and their association. We performed a three parallel arms, double blind, clinical trial randomizing 90 moderately hypercholesterolemic subjects to treatment with phytosterols 800 mg (group 1), red yeast rice standardized to contain 5 mg monacolins from Monascus purpureus (group 2), or both combined nutraceuticals (group 3). After 8 weeks of treatment, in group 1 no significant variation of lipid parameters has been detected. In group 2 a significant reduction (p red yeast rice seems to have additive cholesterol lowering effect, reaching a clinically significant LDL-Cholesterol reduction in mildly hypercholesterolemic patients. ClinicalTrial.gov ID: NCT02603276, Registered 27/08/2015.

  19. The bioavailability and airway clearance of the steroid component of budesonide/formoterol and salmeterol/fluticasone after inhaled administration in patients with COPD and healthy subjects: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Borgström Lars

    2009-10-01

    Full Text Available Abstract Background Airway absorption and bioavailability of inhaled corticosteroids (ICSs may be influenced by differences in pharmacokinetic properties such as lipophilicity and patient characteristics such as lung function. This study aimed to further investigate and clarify the distribution of budesonide and fluticasone in patients with severe chronic obstructive pulmonary disease (COPD by measuring the systemic availability and sputum concentration of budesonide and fluticasone, administered via combination inhalers with the respective long-acting β2-agonists, formoterol and salmeterol. Methods This was a randomized, double-blind, double-dummy, two-way crossover, multicenter study. Following a run-in period, 28 patients with severe COPD (mean age 65 years, mean forced expiratory volume in 1 second [FEV1] 37.5% predicted normal and 27 healthy subjects (mean age 31 years, FEV1 103.3% predicted normal received two single-dose treatments of budesonide/formoterol (400/12 μg and salmeterol/fluticasone (50/500 μg, separated by a 4–14-day washout period. ICS concentrations were measured over 10 hours post-inhalation in plasma in all subjects, and over 6 hours in spontaneously expectorated sputum in COPD patients. The primary end point was the area under the curve (AUC of budesonide and fluticasone plasma concentrations in COPD patients relative to healthy subjects. Results Mean plasma AUC values were lower in COPD patients versus healthy subjects for budesonide (3.07 μM·hr versus 6.21 μM·hr and fluticasone (0.84 μM·hr versus 1.50 μM·hr, and the dose-adjusted AUC (geometric mean ratios in healthy subjects and patients with severe COPD for plasma budesonide and fluticasone were similar (2.02 versus 1.80; primary end point. In COPD patients, the Tmax and the mean residence time in the systemic circulation were shorter for budesonide versus fluticasone (15.5 min versus 50.8 min and 4.41 hrs versus 12.78 hrs, respectively and Cmax was

  20. Competitive Traffic Assignment in Road Networks

    Directory of Open Access Journals (Sweden)

    Krylatov Alexander Y.

    2016-09-01

    Full Text Available Recently in-vehicle route guidance and information systems are rapidly developing. Such systems are expected to reduce congestion in an urban traffic area. This social benefit is believed to be reached by imposing the route choices on the network users that lead to the system optimum traffic assignment. However, guidance service could be offered by different competitive business companies. Then route choices of different mutually independent groups of users may reject traffic assignment from the system optimum state. In this paper, a game theoretic approach is shown to be very efficient to formalize competitive traffic assignment problem with various groups of users in the form of non-cooperative network game with the Nash equilibrium search. The relationships between the Wardrop’s system optimum associated with the traffic assignment problem and the Nash equilibrium associated with the competitive traffic assignment problem are investigated. Moreover, some related aspects of the Nash equilibrium and the Wardrop’s user equilibrium assignments are also discussed.

  1. Impact of Virgin Olive Oil and Phenol-Enriched Virgin Olive Oils on the HDL Proteome in Hypercholesterolemic Subjects: A Double Blind, Randomized, Controlled, Cross-Over Clinical Trial (VOHF Study.

    Directory of Open Access Journals (Sweden)

    Anna Pedret

    Full Text Available The effects of olive oil phenolic compounds (PCs on HDL proteome, with respect to new aspects of cardioprotective properties, are still unknown. The aim of this study was to assess the impact on the HDL protein cargo of the intake of virgin olive oil (VOO and two functional VOOs, enriched with their own PCs (FVOO or complemented with thyme PCs (FVOOT, in hypercholesterolemic subjects. Eligible volunteers were recruited from the IMIM-Hospital del Mar Medical Research Institute (Spain from April 2012 to September 2012. Thirty-three hypercholesterolemic participants (total cholesterol >200 mg/dL; 19 men and 14 women; aged 35 to 80 years were randomized in the double-blind, controlled, cross-over VOHF clinical trial. The subjects received for 3 weeks 25 mL/day of: VOO, FVOO, or FVOOT. Using a quantitative proteomics approach, 127 HDL-associated proteins were identified. Among these, 15 were commonly differently expressed after the three VOO interventions compared to baseline, with specific changes observed for each intervention. The 15 common proteins were mainly involved in the following pathways: LXR/RXR activation, acute phase response, and atherosclerosis. The three VOOs were well tolerated by all participants. Consumption of VOO, or phenol-enriched VOOs, has an impact on the HDL proteome in a cardioprotective mode by up-regulating proteins related to cholesterol homeostasis, protection against oxidation and blood coagulation while down-regulating proteins implicated in acute-phase response, lipid transport, and immune response. The common observed protein expression modifications after the three VOOs indicate a major matrix effect.International Standard Randomized Controlled Trials ISRCTN77500181.

  2. A neural network approach to dynamic task assignment of multirobots.

    Science.gov (United States)

    Zhu, Anmin; Yang, Simon X

    2006-09-01

    In this paper, a neural network approach to task assignment, based on a self-organizing map (SOM), is proposed for a multirobot system in dynamic environments subject to uncertainties. It is capable of dynamically controlling a group of mobile robots to achieve multiple tasks at different locations, so that the desired number of robots will arrive at every target location from arbitrary initial locations. In the proposed approach, the robot motion planning is integrated with the task assignment, thus the robots start to move once the overall task is given. The robot navigation can be dynamically adjusted to guarantee that each target location has the desired number of robots, even under uncertainties such as when some robots break down. The proposed approach is capable of dealing with changing environments. The effectiveness and efficiency of the proposed approach are demonstrated by simulation studies.

  3. Optimal assignment of workers to supporting services in a hospital

    Science.gov (United States)

    Sawik, Bartosz; Mikulik, Jerzy

    2008-01-01

    Supporting services play an important role in health care institutions such as hospitals. This paper presents an application of operations research model for optimal allocation of workers among supporting services in a public hospital. The services include logistics, inventory management, financial management, operations management, medical analysis, etc. The optimality criterion of the problem is to minimize operations costs of supporting services subject to some specific constraints. The constraints represent specific conditions for resource allocation in a hospital. The overall problem is formulated as an integer program in the literature known as the assignment problem, where the decision variables represent the assignment of people to various jobs. The results of some computational experiments modeled on a real data from a selected Polish hospital are reported.

  4. The Vermont Diabetes Information System (VDIS): Study Design and Subject Recruitment for a Cluster Randomized Trial of a Decision Support System in a Regional Sample of Primary Care Practices

    Science.gov (United States)

    MacLean, Charles D.; Littenberg, Benjamin; Gagnon, Michael; Reardon, Mimi; Turner, Paul D.; Jordan, Cy

    2008-01-01

    Background Despite evidence that optimal care for diabetes can result in reduced complications and improved economic outcomes, such care is often not achieved. The Vermont Diabetes Information System (VDIS) is a registry-based decision support and reminder system based on the Chronic Care Model and targeted to primary care physicians and their patients with diabetes. Purpose To develop and evaluate a regional decision support system for patients with diabetes. Methods Randomized trial of an information system with clustering at the practice level. Ten percent random sub sample of patients selected for a home interview. Subject and setting includes 10 hospitals, 121 primary care providers, and 7,348 patients in 55 Vermont and New York primary care practices. Results We report on the study design and baseline characteristics of the population. Patients have a mean age of 63 years and a mean glycosolated hemoglobin A1C of 7.1%. Sixty percent of the population has excellent glycemic control (A1C<7%); 45% have excellent lipid control (serum LDL-cholesterol < 100mg/dl and serum triglycerides < 400mg/dl). Twenty-five percent have excellent blood pressure control (<130/80 mm Hg). These results compare favorably to recent national reports. However, only 8% are in optimal control for all three of hyperglycemia, lipids and blood pressure. Conclusions Our experience to date indicates that a low cost decision support and information system based on the chronic care model is feasible in primary care practices that lack sophisticated electronic information systems. VDIS is well accepted by patients, providers, and laboratory staff. If proven beneficial in a rigorous, randomized, controlled evaluation, the intervention could be widely disseminated to practices across America and the world with a substantial impact on the outcomes and costs of diabetes. It could also be adapted to other chronic conditions. We anticipate the results of the study will be available in 2006. PMID

  5. Self-discrimination and memory: state orientation and false self-ascription of assigned activities.

    Science.gov (United States)

    Kuhl, J; Kazén, M

    1994-06-01

    A new paradigm to investigate the tendency to falsely ascribe to oneself assigned goals (misinformed introjection or self-infiltration) and the better memory of self-chosen than of assigned prospective activities (self-choice effect) is explored. In two experiments, state-oriented subjects showed significantly higher rates of false self-ascriptions of assigned activities than action-oriented subjects did (an individual-difference factor related to volitional efficiency; Kuhl & Beckmann, 1994b), whereas all subjects gave evidence of the self-choice effect. Specific manipulations to reduce and to increase the probability of occurrence of false self-ascriptions were also carried out (an intentional-learning instruction and task interruption, respectively). Finally, a first step was taken to examine the relationship between self-infiltration and the tendency to enact more self-chosen than assigned activities (self-determination).

  6. Flexible taxonomic assignment of ambiguous sequencing reads

    Directory of Open Access Journals (Sweden)

    Jansson Jesper

    2011-01-01

    Full Text Available Abstract Background To characterize the diversity of bacterial populations in metagenomic studies, sequencing reads need to be accurately assigned to taxonomic units in a given reference taxonomy. Reads that cannot be reliably assigned to a unique leaf in the taxonomy (ambiguous reads are typically assigned to the lowest common ancestor of the set of species that match it. This introduces a potentially severe error in the estimation of bacteria present in the sample due to false positives, since all species in the subtree rooted at the ancestor are implicitly assigned to the read even though many of them may not match it. Results We present a method that maps each read to a node in the taxonomy that minimizes a penalty score while balancing the relevance of precision and recall in the assignment through a parameter q. This mapping can be obtained in time linear in the number of matching sequences, because LCA queries to the reference taxonomy take constant time. When applied to six different metagenomic datasets, our algorithm produces different taxonomic distributions depending on whether coverage or precision is maximized. Including information on the quality of the reads reduces the number of unassigned reads but increases the number of ambiguous reads, stressing the relevance of our method. Finally, two measures of performance are described and results with a set of artificially generated datasets are discussed. Conclusions The assignment strategy of sequencing reads introduced in this paper is a versatile and a quick method to study bacterial communities. The bacterial composition of the analyzed samples can vary significantly depending on how ambiguous reads are assigned depending on the value of the q parameter. Validation of our results in an artificial dataset confirm that a combination of values of q produces the most accurate results.

  7. Pilot study on recurrent aphthous stomatitis (RAS): a randomized placebo-controlled trial for the comparative therapeutic effects of systemic prednisone and systemic montelukast in subjects unresponsive to topical therapy.

    Science.gov (United States)

    Femiano, F; Buonaiuto, C; Gombos, F; Lanza, A; Cirillo, N

    2010-03-01

    Recurrent aphthous stomatitis (RAS) is characterized by recurrent painful oral ulcers whose etiology remains largely unknown. Numerous therapeutic protocols have been tried so far, but effectiveness remains an issue. To test a new drug for patients with recurrent oral aphthae nonresponsive to local corticosteroid therapy, we compared the therapeutic effectiveness and adverse effects of systemic prednisone and systemic montelukast in a placebo-controlled trial. Sixty patients suffering from minor RAS for > or =6 months were studied and randomly assigned to 3 groups of 20 each in a double-blind study. Patients of group A took 25 mg prednisone orally daily for 15 days, 12.5 mg daily for 15 days, 6.25 mg daily for 15 days, then 6.25 mg on alternate days for 15 days. Patients of group B took 10 mg montelukast orally every evening and then on alternate days for the second month. Patients of group C took 100 mg cellulose (placebo) by mouth daily for the first month and on alternate days for the second month. Outcomes assessed were days til pain cessation, days to ulcer healing, and number of aphthae occurring during the follow-up period. Both prednisone and montelukast were effective in reducing the number of lesions and improving pain relief and ulcer healing when compared with placebo. Prednisone was more effective than montelukast in pain cessation (P < .0001) and in accelerating ulcer healing (P < .0001). However, adverse drug reactions recorded during the entire trial were more common in the prednisone group compared with montelukast (10%) and placebo (10%). These data suggest that the effectiveness of systemic montelukast is similar to that of systemic prednisone in patients with RAS. The lack of serious side effects makes montelukast a candidate drug to use in cases of RAS where pharmacologic therapy for long periods is needed. Copyright 2010 Mosby, Inc. All rights reserved.

  8. Testing brief intervention and phone contact among subjects with suicidal behavior: a randomized controlled trial in French Polynesia in the frames of the World Health Organization/Suicide Trends in At-Risk Territories study

    Directory of Open Access Journals (Sweden)

    Stéphane Amadéo

    2015-10-01

    Full Text Available The World Health Organization Suicide trends in at-risk territories study is a multi-site regional research program operating first in French Polynesia and countries of the Western Pacific, then extended to the world. The aims of the study were to establish a monitoring system for suicidal behaviors and to conduct a randomised control trial intervention for non-fatal suicidal behaviors. The latter part is the purpose of the present article. Over the period 2008-2010, 515 patients were admitted at the Emergency Department of the Centre Hospitalier de Polynésie Française for suicidal behavior. Those then hospitalized in the Psychiatry Emergency Unit were asked to be involved in the study and randomly allocated to either Treatment As Usual (TAU or TAU plus Brief Intervention and Contact (BIC, which provides a psycho-education session and a follow-up of 9 phone contacts over an 18-months period. One hundred persons were assigned to TAU, while 100 participants were allocated to the BIC group. At the end of the follow-up there were no significant differences between the two groups in terms of number of presentations to the hospital for repeated suicidal behaviors. Although the study could not demonstrate the superiority of a treatment over the other, nevertheless – given its importance – the investigation captured public attention and was able to contribute to the awareness of the need of suicide prevention in French Polynesia. The BIC model of intervention seemed to particularly suit the geographical and health care context of the country.

  9. The Effect of Low-Dose Marine n-3 Fatty Acids on Plasma Levels of sCD36 in Overweight Subjects: A Randomized, Double-Blind, Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Erik Berg Schmidt

    2013-08-01

    Full Text Available CD36 is a scavenger receptor involved in lipid uptake and inflammation. Recently, non-cell-bound CD36 (sCD36 was identified in plasma and suggested to be a marker of lipid accumulation in the vessel wall. Marine n-3 polyunsaturated fatty acids (PUFA may have cardioprotective effects. This study evaluated the effect of marine n-3 PUFA on sCD36 levels in overweight subjects. Fifty overweight subjects were randomized to 1.1 g of n-3 PUFA or 2 g of olive oil daily for six weeks. Neutrophils were isolated at baseline and after six weeks of treatment while an adipose tissue biopsy was obtained at baseline. The content of n-3 PUFA in adipose tissue and neutrophils was analyzed by gas chromatography, while plasma levels of sCD36 were determined using an enzyme-linked immunosorbent assay (ELISA. After six weeks of supplement plasma sCD36 did not differ between supplements (P = 0.18. There was no significant correlation between plasma sCD36 levels and n-3 PUFA in neutrophils at baseline (r = −0.02, P = 0.88, after six weeks supplement (r = −0.03, P = 0.85 or in adipose tissue (r = 0.14, P = 0.34. This study therefore does not provide evidence for a cardioprotective effect of n-3 PUFA acting through a CD36-dependent mechanism.

  10. Psychomotor and subjective effects of bilastine, hydroxyzine, and cetirizine, in combination with alcohol: a randomized, double-blind, crossover, and positive-controlled and placebo-controlled Phase I clinical trials.

    Science.gov (United States)

    García-Gea, Consuelo; Martínez, Joan; Ballester, Maria Rosa; Gich, Ignasi; Valiente, Román; Antonijoan, Rosa Maria

    2014-03-01

    The aim of this study was to compare the effects of concomitant administration of alcohol and bilastine versus alcohol alone on the central nervous system. Twenty-four healthy young volunteers of both sexes participated in a randomized, double-blind, double-dummy, crossover, and positive-controlled and placebo-controlled clinical trials. At 1-week intervals, subjects received six different treatments: (i) placebo; (ii) alcohol 0.8 g/kg alone (ALC); (iii) ALC in combination with: bilastine 20 mg (B20 + A); (iv) bilastine 80 mg (B80 + A); (v) cetirizine 10 mg (CET + A); and (vi) hydroxyzine 25 mg (HYD + A). Psychomotor performance tests (fine motor, finger tapping, nystagmus, critical flicker-fusion frequency, temporal estimation, 'd2' cancellation, and simple reaction time) and subjective self-reports (drunkenness, drowsiness, mental slowness, clumsiness, anger, attentiveness, competence, happiness, hostility, interest, and extroversion) were carried out at baseline and multiple points thereafter. All active treatments induced a significant psychomotor impairment. The greatest and most lasting impairment was observed with HYD + A followed by B80 + A and CET + A. In contrast, objective measures showed less impairment with B20 + A and ALC, both with a similar magnitude. Self-reports showed a subjective perception of performance impairment in all active treatments. Concomitant administration of bilastine (at therapeutic dose) and alcohol does not produce greater central nervous system depressant effects than ACL alone. Copyright © 2014 John Wiley & Sons, Ltd.

  11. Protein secondary structure assignment revisited: a detailed analysis of different assignment methods

    Directory of Open Access Journals (Sweden)

    de Brevern Alexandre G

    2005-09-01

    Full Text Available Abstract Background A number of methods are now available to perform automatic assignment of periodic secondary structures from atomic coordinates, based on different characteristics of the secondary structures. In general these methods exhibit a broad consensus as to the location of most helix and strand core segments in protein structures. However the termini of the segments are often ill-defined and it is difficult to decide unambiguously which residues at the edge of the segments have to be included. In addition, there is a "twilight zone" where secondary structure segments depart significantly from the idealized models of Pauling and Corey. For these segments, one has to decide whether the observed structural variations are merely distorsions or whether they constitute a break in the secondary structure. Methods To address these problems, we have developed a method for secondary structure assignment, called KAKSI. Assignments made by KAKSI are compared with assignments given by DSSP, STRIDE, XTLSSTR, PSEA and SECSTR, as well as secondary structures found in PDB files, on 4 datasets (X-ray structures with different resolution range, NMR structures. Results A detailed comparison of KAKSI assignments with those of STRIDE and PSEA reveals that KAKSI assigns slightly longer helices and strands than STRIDE in case of one-to-one correspondence between the segments. However, KAKSI tends also to favor the assignment of several short helices when STRIDE and PSEA assign longer, kinked, helices. Helices assigned by KAKSI have geometrical characteristics close to those described in the PDB. They are more linear than helices assigned by other methods. The same tendency to split long segments is observed for strands, although less systematically. We present a number of cases of secondary structure assignments that illustrate this behavior. Conclusion Our method provides valuable assignments which favor the regularity of secondary structure segments.

  12. The Airport Gate Assignment Problem: A Survey

    Directory of Open Access Journals (Sweden)

    Abdelghani Bouras

    2014-01-01

    Full Text Available The airport gate assignment problem (AGAP is one of the most important problems operations managers face daily. Many researches have been done to solve this problem and tackle its complexity. The objective of the task is assigning each flight (aircraft to an available gate while maximizing both conveniences to passengers and the operational efficiency of airport. This objective requires a solution that provides the ability to change and update the gate assignment data on a real time basis. In this paper, we survey the state of the art of these problems and the various methods to obtain the solution. Our survey covers both theoretical and real AGAP with the description of mathematical formulations and resolution methods such as exact algorithms, heuristic algorithms, and metaheuristic algorithms. We also provide a research trend that can inspire researchers about new problems in this area.

  13. The Airport Gate Assignment Problem: A Survey

    Science.gov (United States)

    Ghaleb, Mageed A.; Salem, Ahmed M.

    2014-01-01

    The airport gate assignment problem (AGAP) is one of the most important problems operations managers face daily. Many researches have been done to solve this problem and tackle its complexity. The objective of the task is assigning each flight (aircraft) to an available gate while maximizing both conveniences to passengers and the operational efficiency of airport. This objective requires a solution that provides the ability to change and update the gate assignment data on a real time basis. In this paper, we survey the state of the art of these problems and the various methods to obtain the solution. Our survey covers both theoretical and real AGAP with the description of mathematical formulations and resolution methods such as exact algorithms, heuristic algorithms, and metaheuristic algorithms. We also provide a research trend that can inspire researchers about new problems in this area. PMID:25506074

  14. Assignment of fields from particles to mesh

    CERN Document Server

    Duque, Daniel

    2016-01-01

    In Computational Fluid Dynamics there have been many attempts to combine the power of a fixed mesh on which to carry out spatial calculations with that of a set of particles that moves following the velocity field. These ideas indeed go back to Particle-in-Cell methods, proposed about 60 years ago. Of course, some procedure is needed to transfer field information between particles and mesh. There are many possible choices for this "assignment", or "projection". Several requirements may guide this choice. Two well-known ones are conservativity and stability, which apply to volume integrals of the fields. An additional one is here considered: preservation of information. This means that mesh interpolation, followed by mesh assignment, should leave the field values invariant. The resulting methods are termed "mass" assignments due to their strong similarities with the Finite Element Method. We test several procedures, including the well-known FLIP, on three scenarios: simple 1D convection, 2D convection of Zales...

  15. SUBJECT INDEX

    Indian Academy of Sciences (India)

    Subject Index. Variation of surface electric field during geomagnetic disturbed period at Maitri, Antarctica. 1721. Geomorphology. A simple depression-filling method for raster and irregular elevation datasets. 1653. Decision Support System integrated with Geographic. Information System to target restoration actions in water-.

  16. Writing Assignments that Promote Active Learning

    Science.gov (United States)

    Narayanan, M.

    2014-12-01

    Encourage students to write a detailed, analytical report correlating classroom discussions to an important historical event or a current event. Motivate students interview an expert from industry on a topic that was discussed in class. Ask the students to submit a report with supporting sketches, drawings, circuit diagrams and graphs. Propose that the students generate a complete a set of reading responses pertaining to an assigned topic. Require each student to bring in one comment or one question about an assigned reading. The assignment should be a recent publication in an appropriate journal. Have the students conduct a web search on an assigned topic. Ask them to generate a set of ideas that can relate to classroom discussions. Provide the students with a study guide. The study guide should provide about 10 or 15 short topics. Quiz the students on one or two of the topics. Encourage the students to design or develop some creative real-world examples based on a chapter discussed or a topic of interest. Require that students originate, develop, support and defend a viewpoint using a specifically assigned material. Make the students practice using or utilizing a set of new technical terms they have encountered in an assigned chapter. Have students develop original examples explaining the different terms. Ask the students to select one important terminology from the previous classroom discussions. Encourage the students to explain why they selected that particular word. Ask them to talk about the importance of the terminology from the point of view of their educational objectives and future career. Angelo, T. A. (1991). Ten easy pieces: Assessing higher learning in four dimensions. In T. A. Angelo (Ed.), Classroom research: Early lessons from success (pp. 17-31). New Directions for Teaching and Learning, No. 46. San Francisco: Jossey-Bass.

  17. The pharmacokinetics and safety of a fixed-dose combination of acetylsalicylic acid and clopidogrel compared with the concurrent administration of acetylsalicylic acid and clopidogrel in healthy subjects: a randomized, open-label, 2-sequence, 2-period, single-dose crossover study.

    Science.gov (United States)

    Jung, Jin Ah; Kim, Tae-Eun; Kim, Jung-Ryul; Kim, Min-Ji; Huh, Wooseong; Park, Kyung-Mi; Lee, Soo-Youn; Ko, Jae-Wook

    2013-07-01

    Dual antiplatelet therapy with clopidogrel plus acetylsalicylic acid (ASA) is used for the treatment of acute coronary syndrome. A combined formulation of ASA and clopidogrel has been developed to provide dosing convenience and improve adherence. This study was designed to compare the pharmacokinetic properties and safety profile of a fixed-dose combination formulation of ASA and clopidogrel with concurrent administration of each agent in healthy male Korean volunteers. This single-dose, randomized, open-label, 2-period crossover study was conducted in 64 healthy Korean volunteers. Equal numbers of eligible participants were randomly assigned to receive either the fixed-dose combination of ASA 100 mg and clopidogrel 75 mg or the free combination of each agent followed by a 7-day washout period and then administration of the alternate formulation. Serial blood samples were collected immediately before and after dosing for 24 hours. The safety profile was evaluated by using adverse events (AEs), which were assessed by physical examination, vital signs, ECGs, clinical laboratory tests, and interviews. The 2 formulations were considered to be bioequivalent if the 90% CIs for the log-transformed C(max) and AUC(0-last) values were within the predetermined range of 0.8 to 1.25. Sixty-four volunteers (mean [SD] age, 27.51 [8.15] years; weight, 68.55 [7.86] kg; height, 173.80 [5.94] cm) were enrolled, and 63 completed the study. For ASA, the 90% CIs for the geometric mean ratios of C(max) and AUC(0-last) were 0.9483 to 1.1717 and 0.9946 to 1.1020, respectively. For salicylic acid, the 90% CIs were 0.9614 to 1.0396 for C(max) and 0.9778 to 1.0163 for AUC(0-last). For clopidogrel, the 90% CIs were 0.9809 to 1.2562 for C(max) and 0.9674 to 1.2073 for AUC(0-last). Six of the 20 AEs reported were drug related: decreased hemoglobin levels (n = 2), fever (n = 1), and headache (n = 1) with the test formulation and increased alanine aminotransferase levels (n = 1) and dyspepsia (n

  18. Manganese Oxidation State Assignment for Manganese Catalase.

    Science.gov (United States)

    Beal, Nathan J; O'Malley, Patrick J

    2016-04-06

    The oxidation state assignment of the manganese ions present in the superoxidized manganese (III/IV) catalase active site is determined by comparing experimental and broken symmetry density functional theory calculated (14)N, (17)O, and (1)H hyperfine couplings. Experimental results have been interpreted to indicate that the substrate water is coordinated to the Mn(III) ion. However, by calculating hyperfine couplings for both scenarios we show that water is coordinated to the Mn(IV) ion and that the assigned oxidation states of the two manganese ions present in the site are the opposite of that previously proposed based on experimental measurements alone.

  19. Comparisons of the pharmacokinetics and tolerability of fixed-dose combinations of amlodipine besylate/losartan and amlodipine camsylate/losartan in healthy subjects: a randomized, open-label, single-dose, two-period, two-sequence crossover study.

    Science.gov (United States)

    Choi, YoonJung; Lee, SeungHwan; Cho, Sang-Min; Kang, Won-Ho; Nam, Kyu-Yeol; Jang, In-Jin; Yu, Kyung-Sang

    2016-01-01

    A fixed-dose combination (FDC) of amlodipine and losartan has been used to reduce blood pressure in patients whose hypertension is not sufficiently controlled with either drug alone. The aim of this study was to evaluate the pharmacokinetic (PK) characteristics and tolerability of an FDC of 6.94 mg amlodipine besylate (5 mg as amlodipine)/50 mg losartan potassium compared to an FDC of 5 mg amlodipine camsylate/50 mg losartan potassium in healthy subjects. A randomized, open-label, single-dose, two-period, two-sequence crossover study was conducted on 46 healthy male subjects. Blood concentrations were measured by liquid chromatography-tandem mass spectrometry. Blood samples were collected up to 144 hours post dose for each period. PK parameters were calculated in each treatment group using a noncompartmental method. The 90% confidence intervals (CIs) of the geometric mean ratios of the two treatments for the maximum plasma concentration (Cmax) and the area under the concentration curve from time zero to the last quantifiable time point (AUC0-t) were estimated. Tolerability assessments were performed for all subjects who received the drug at least once. The PK profiles of the two treatments were similar. For amlodipine, the geometric mean ratios (90% CIs) of amlodipine besylate to amlodipine camsylate for the Cmax and AUC0-t were 0.98 (0.94-1.01) and 0.97 (0.93-1.01), respectively. The corresponding values for losartan were 0.91 (0.81-1.02) and 1.05 (0.98-1.12), respectively. The incidence of adverse events was not significantly different between the two treatments, and both were well tolerated. An FDC of 6.94 mg amlodipine besylate (5 mg as amlodipine)/50 mg losartan potassium produced similar results to an FDC of 5 mg amlodipine camsylate/50 mg losartan potassium treatment with respect to the PK parameters of amlodipine and losartan based on Cmax and AUC0-t values. The amlodipine besylate/losartan potassium combination was well tolerated by healthy male subjects.

  20. A soy-based phosphatidylserine/ phosphatidic acid complex (PAS) normalizes the stress reactivity of hypothalamus-pituitary-adrenal-axis in chronically stressed male subjects: a randomized, placebo-controlled study.

    Science.gov (United States)

    Hellhammer, Juliane; Vogt, Dominic; Franz, Nadin; Freitas, Ulla; Rutenberg, David

    2014-07-31

    Supplementation with a phosphatidylserine and phosphatidylserine/ phosphatidic acid complex (PAS) has been observed to normalize stress induced dysregulations of the hypothalamus-pituitary-adrenal axis (HPAA). Prolonged stress first induces a hyper-activation of the HPAA, which then can be followed by a state of hypo-activation.The aim of this study was to examine effects of an oral supplementation with 400 mg PS & 400 mg PA (PAS 400) per day on the endocrine stress response (ACTH, saliva and serum cortisol) to a psychosocial stressor. A special focus was to analyze subgroups of low versus high chronically stressed subjects as well as to test efficacy of 200 mg PS & 200 mg PA (PAS 200). 75 healthy male volunteers were enrolled for this double-blind, placebo-controlled study, stratified by chronic stress level, and randomly allocated to one of three study arms (placebo, PAS 200 and PAS 400 per day, respectively). Study supplementation was administered for 42 days for each participant. Chronic stress was measured with the Trier Inventory for Chronic Stress (TICS), and subgroups of high and low chronic stress were differentiated by median values as provided by the TICS authors. A six week period of supplementation was followed by an acute stress test (Trier Social Stress Test - TSST). Chronic stress levels and other baseline measures did not differ between treatment groups (all p>0.05). Acute stress was successfully induced by the TSST and resulted in a hyper-responsivity of the HPAA in chronically stressed subjects. Compared to placebo, a supplementation with a daily dose of PAS 400 was effective in normalizing the ACTH (p=0.010), salivary (p=0.043) and serum cortisol responses (p=0.035) to the TSST in chronically high but not in low stressed subjects (all p>0.05). Compared to placebo, supplementation with PAS 200 did not result in any significant differences in these variables (all p>0.05). There were no significant effects of supplementation with PAS on heart rate

  1. Treatment Assignment Guesses by Study Participants in a Double-Blind Dose Escalation Clinical Trial of Saw Palmetto

    OpenAIRE

    Lee, Jeannette Y.; Moore, Page; Kusek, John; Barry, Michael

    2014-01-01

    Objectives: This report assesses participant perception of treatment assignment in a randomized, double-blind, placebo-controlled trial of saw palmetto for the treatment of benign prostatic hyperplasia (BCM).

  2. 48 CFR 208.7002 - Assignment authority.

    Science.gov (United States)

    2010-10-01

    ... activities concerned. (b) Under the Integrated Materiel Management Program, assignments are made by the... Secretary of Defense (Logistics); (2) To GSA, through agreement with GSA, by the Deputy Under Secretary of Defense (Logistics); (3) Outside the contiguous United States, by the Unified Commanders; and (4) For...

  3. Assigning sporadic tasks to unrelated machines

    NARCIS (Netherlands)

    Marchetti-Spaccamela, A.; Rutten, C.; van der Ster, S.L.; Wiese, A.

    2015-01-01

    We study the problem of assigning sporadic tasks to unrelated machines such that the tasks on each machine can be feasibly scheduled. Despite its importance for modern real-time systems, this problem has not been studied before. We present a polynomial-time algorithm which approximates the problem

  4. Generalised Assignment Matrix Methodology in Linear Programming

    Science.gov (United States)

    Jerome, Lawrence

    2012-01-01

    Discrete Mathematics instructors and students have long been struggling with various labelling and scanning algorithms for solving many important problems. This paper shows how to solve a wide variety of Discrete Mathematics and OR problems using assignment matrices and linear programming, specifically using Excel Solvers although the same…

  5. A Generalized Assignment Heuristic for Vehicle Routing

    Science.gov (United States)

    1979-08-01

    operating costs included in objective (1) of (VRP). This kind of parametric analysis would be useful, for example, in evaluating vehicle acquisition decisions...of solution qcuality and runnina time for the five methods. In terms of solution cualit -i, the Fisher-Jaikumar generalized assignment method clearly

  6. Credit assignment during movement reinforcement learning.

    Science.gov (United States)

    Dam, Gregory; Kording, Konrad; Wei, Kunlin

    2013-01-01

    We often need to learn how to move based on a single performance measure that reflects the overall success of our movements. However, movements have many properties, such as their trajectories, speeds and timing of end-points, thus the brain needs to decide which properties of movements should be improved; it needs to solve the credit assignment problem. Currently, little is known about how humans solve credit assignment problems in the context of reinforcement learning. Here we tested how human participants solve such problems during a trajectory-learning task. Without an explicitly-defined target movement, participants made hand reaches and received monetary rewards as feedback on a trial-by-trial basis. The curvature and direction of the attempted reach trajectories determined the monetary rewards received in a manner that can be manipulated experimentally. Based on the history of action-reward pairs, participants quickly solved the credit assignment problem and learned the implicit payoff function. A Bayesian credit-assignment model with built-in forgetting accurately predicts their trial-by-trial learning.

  7. Tabu search for target-radar assignment

    DEFF Research Database (Denmark)

    Hindsberger, Magnus; Vidal, Rene Victor Valqui

    2000-01-01

    In the paper the problem of assigning air-defense illumination radars to enemy targets is presented. A tabu search metaheuristic solution is described and the results achieved are compared to those of other heuristic approaches, implementation and experimental aspects are discussed. It is argued...

  8. 47 CFR 74.702 - Channel assignments.

    Science.gov (United States)

    2010-10-01

    ... land mobile radio operations. (b) Changes in the TV Table of Allotments or Digital Television Table of..., AUXILIARY, SPECIAL BROADCAST AND OTHER PROGRAM DISTRIBUTIONAL SERVICES Low Power TV, TV Translator, and TV Booster Stations § 74.702 Channel assignments. (a) An applicant for a new low power TV or TV translator...

  9. Training the American Businessman for Foreign Assignment

    Science.gov (United States)

    Harris, Philip R.; Harris, Dorothy L.

    1972-01-01

    Describes a program in cross cultural training for the American businessman about to go on foreign assignment which should increase employee effectiveness when serving outside one's own country or when working with minority groups within the United States." (Author/DR)

  10. Teachers' Grading Practices: Meaning and Values Assigned

    Science.gov (United States)

    Sun, Youyi; Cheng, Liying

    2014-01-01

    This study explores the meaning Chinese secondary school English language teachers associate with the grades they assign to their students, and the value judgements they make in grading. A questionnaire was issued to 350 junior and senior school English language teachers in China. The questionnaire data were analysed both quantitatively and…

  11. Enhanced functional and structural domain assignments using ...

    Indian Academy of Sciences (India)

    The sequencing of the Mycobacterium tuberculosis (MTB) H37Rv genome has facilitated deeper insights into the biology of MTB, yet the functions of many MTB proteins are unknown. We have used sensitive profile-based search procedures to assign functional and structural domains to infer functions of gene products ...

  12. Teaching Historical Analysis through Creative Writing Assignments

    Science.gov (United States)

    Peterson, Janine Larmon; Graham, Lea

    2015-01-01

    Incorporating creative writing exercises in history courses can heighten students' critical reading and analytical skills in an active learning model. We identify and define two types of possible assignments that use model texts as their locus: centripetal, which focuses on specific context and disciplinary terms, and centrifugal, which address…

  13. School Assignment, School Choice and Social Mobility

    Science.gov (United States)

    Burgess, Simon; Briggs, Adam

    2010-01-01

    We estimate the chances of poor and non-poor children getting places in good schools, analysing the relationship between poverty, location and school assignment. Our dataset allows us to measure location and distance very precisely. The simple unconditional difference in probabilities of attending a good school is substantial. We run an analysis…

  14. 7 CFR 1437.104 - Assigned production.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false Assigned production. 1437.104 Section 1437.104 Agriculture Regulations of the Department of Agriculture (Continued) COMMODITY CREDIT CORPORATION, DEPARTMENT OF AGRICULTURE LOANS, PURCHASES, AND OTHER OPERATIONS NONINSURED CROP DISASTER ASSISTANCE PROGRAM...

  15. income tax assignment under the ethiopian constitution

    African Journals Online (AJOL)

    eliasn

    Constitution from an income tax point of view. And finally, the article ends with some concluding remarks. 1. Theories of Fiscal Federalism In Income Tax Assignment. Few countries pursue the course of decentralization on grounds of its perceived economic efficiency or equity. Political, social, cultural or historical forces are.

  16. Politics, Internet Assignments, and Civic Knowledge.

    Science.gov (United States)

    May, Vaughn

    2000-01-01

    Describes how one professor of American government fights the apathy and cynicism of college students toward politics by using the Internet to help students more fairly appraise the workings of the American political system. One assignment has students research and manage a particular public policy initiative through visits to Web sites…

  17. 47 CFR 74.602 - Frequency assignment.

    Science.gov (United States)

    2010-10-01

    ... Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES EXPERIMENTAL RADIO... 2450 and 2500 MHz are also shared with other communication services and exclusive channel assignments... Emerging Technologies licensee in accordance with § 74.690 or § 78.40. Licensees declining relocation may...

  18. Accounting for Sustainability: An Active Learning Assignment

    Science.gov (United States)

    Gusc, Joanna; van Veen-Dirks, Paula

    2017-01-01

    Purpose: Sustainability is one of the newer topics in the accounting courses taught in university teaching programs. The active learning assignment as described in this paper was developed for use in an accounting course in an undergraduate program. The aim was to enhance teaching about sustainability within such a course. The purpose of this…

  19. Incentivized optimal advert assignment via utility decomposition

    NARCIS (Netherlands)

    Kelly, F.; Key, P.; Walton, N.

    2014-01-01

    We consider a large-scale Ad-auction where adverts are assigned over a potentially infinite number of searches. We capture the intrinsic asymmetries in information between advertisers, the advert platform and the space of searches: advertisers know and can optimize the average performance of their

  20. Semi-infinite assignment and transportation games

    NARCIS (Netherlands)

    Timmer, Judith B.; Sánchez-Soriano, Joaqu´ın; Llorca, Navidad; Tijs, Stef; Goberna, Miguel A.; López, Marco A.

    2001-01-01

    Games corresponding to semi-infinite transportation and related assignment situations are studied. In a semi-infinite transportation situation, one aims at maximizing the profit from the transportation of a certain good from a finite number of suppliers to an infinite number of demanders. An

  1. Democratization of Learning through Thematic Assignment

    Science.gov (United States)

    Medellu, Christophil S.; Lumingkewas, S.; Walangitan, J. F.

    2015-01-01

    This article describes the results of research on learning democratization in Sangihe. This study is the first year of a five-year plan. Long-term goal of this research is to create the democratic science learning in schools. Democratic learning model was developed through thematic assignment, involving the participation of parents and…

  2. On Online Assignments in a Calculus Class

    Science.gov (United States)

    Jungic, Veselin; Kent, Deborah; Menz, Petra

    2012-01-01

    In this paper, we describe our experience with the creation and utilization of online assignments for several calculus classes at Simon Fraser University (SFU). We present our findings regarding available software by considering the needs and perspectives of the instructors, students, and administrators. We provide a list of questions that guide…

  3. Daily electronic monitoring of subjective and objective measures of illness activity in bipolar disorder using smartphones--the MONARCA II trial protocol: a randomized controlled single-blind parallel-group trial.

    Science.gov (United States)

    Faurholt-Jepsen, Maria; Vinberg, Maj; Frost, Mads; Christensen, Ellen Margrethe; Bardram, Jakob; Kessing, Lars Vedel

    2014-11-25

    Patients with bipolar disorder often show decreased adherence with mood stabilizers and frequently interventions on prodromal depressive and manic symptoms are delayed. Recently, the MONARCA I randomized controlled trial investigated the effect of electronic self-monitoring using smartphones on depressive and manic symptoms. The findings suggested that patients using the MONARCA system had more sustained depressive symptoms than patients using a smartphone for normal communicative purposes, but had fewer manic symptoms during the trial. It is likely that the ability of these self-monitored measures to detect prodromal symptoms of depression and mania may be insufficient compared to automatically generated objective data on measures of illness activity such as phone usage, social activity, physical activity, and mobility. The Monsenso system, for smartphones integrating subjective and objective measures of illness activity was developed and will be tested in the present trial. The MONARCA II trial uses a randomized controlled single-blind parallel-group design. Patients with bipolar disorder according to ICD-10 who previously have been treated at the Copenhagen Clinic for Affective Disorder, Denmark are included and randomized to either daily use of the Monsenso system including an feedback loop between patients and clinicians (the intervention group) or to the use of a smartphone for normal communicative purposes (the control group) for a 9-month trial period. The trial was started in September 2014 and recruitment is ongoing. The outcomes are: differences in depressive and manic symptoms; rate of depressive and manic episodes (primary); automatically generated objective data on measures of illness activity; number of days hospitalized; psychosocial functioning (secondary); perceived stress; quality of life; self-rated depressive symptoms; self-rated manic symptoms; recovery; empowerment and adherence to medication (tertiary) between the intervention group and the

  4. On the expected number of assignments in reduced matrices for the linear assignment problem

    NARCIS (Netherlands)

    Nawijn, W.M.; Dorhout, B.

    1989-01-01

    A linear n × n assignment problem is considered for which the elements of the cost matrix are sampled from a continuous probability distribution. Based on the zero entries of the reduced matrix the expectation of the maximum number of initial assignments is determined for general n, as well as an

  5. Stereospecific assignment of the asparagine and glutamine sidechain amide protons in proteins from chemical shift analysis

    Energy Technology Data Exchange (ETDEWEB)

    Harsch, Tobias; Schneider, Philipp; Kieninger, Bärbel; Donaubauer, Harald; Kalbitzer, Hans Robert, E-mail: hans-robert.kalbitzer@biologie.uni-regensburg.de [University of Regensburg, Institute of Biophysics and Physical Biochemistry and Centre of Magnetic Resonance in Chemistry and Biomedicine (Germany)

    2017-02-15

    Side chain amide protons of asparagine and glutamine residues in random-coil peptides are characterized by large chemical shift differences and can be stereospecifically assigned on the basis of their chemical shift values only. The bimodal chemical shift distributions stored in the biological magnetic resonance data bank (BMRB) do not allow such an assignment. However, an analysis of the BMRB shows, that a substantial part of all stored stereospecific assignments is not correct. We show here that in most cases stereospecific assignment can also be done for folded proteins using an unbiased artificial chemical shift data base (UACSB). For a separation of the chemical shifts of the two amide resonance lines with differences ≥0.40 ppm for asparagine and differences ≥0.42 ppm for glutamine, the downfield shifted resonance lines can be assigned to H{sup δ21} and H{sup ε21}, respectively, at a confidence level >95%. A classifier derived from UASCB can also be used to correct the BMRB data. The program tool AssignmentChecker implemented in AUREMOL calculates the Bayesian probability for a given stereospecific assignment and automatically corrects the assignments for a given list of chemical shifts.

  6. Differential acute postprandial effects of processed meat and isocaloric vegan meals on the gastrointestinal hormone response in subjects suffering from type 2 diabetes and healthy controls: a randomized crossover study.

    Science.gov (United States)

    Belinova, Lenka; Kahleova, Hana; Malinska, Hana; Topolcan, Ondrej; Vrzalova, Jindra; Oliyarnyk, Olena; Kazdova, Ludmila; Hill, Martin; Pelikanova, Terezie

    2014-01-01

    The intake of meat, particularly processed meat, is a dietary risk factor for diabetes. Meat intake impairs insulin sensitivity and leads to increased oxidative stress. However, its effect on postprandial gastrointestinal hormone (GIH) secretion is unclear. We aimed to investigate the acute effects of two standardized isocaloric meals: a processed hamburger meat meal rich in protein and saturated fat (M-meal) and a vegan meal rich in carbohydrates (V-meal). We hypothesized that the meat meal would lead to abnormal postprandial increases in plasma lipids and oxidative stress markers and impaired GIH responses. In a randomized crossover study, 50 patients suffering from type 2 diabetes (T2D) and 50 healthy subjects underwent two 3-h meal tolerance tests. For statistical analyses, repeated-measures ANOVA was performed. The M-meal resulted in a higher postprandial increase in lipids in both groups (p<0.001) and persistent postprandial hyperinsulinemia in patients with diabetes (p<0.001). The plasma glucose levels were significantly higher after the V-meal only at the peak level. The plasma concentrations of glucose-dependent insulinotropic peptide (GIP), peptide tyrosine-tyrosine (PYY) and pancreatic polypeptide (PP) were higher (p<0.05, p<0.001, p<0.001, respectively) and the ghrelin concentration was lower (p<0.001) after the M-meal in healthy subjects. In contrast, the concentrations of GIP, PYY and PP were significantly lower after the M-meal in T2D patients (p<0.001). Compared with the V-meal, the M-meal was associated with a larger increase in lipoperoxidation in T2D patients (p<0.05). Our results suggest that the diet composition and the energy content, rather than the carbohydrate count, should be important considerations for dietary management and demonstrate that processed meat consumption is accompanied by impaired GIH responses and increased oxidative stress marker levels in diabetic patients. ClinicalTrials.gov NCT01572402.

  7. Group-based multimodal exercises integrated with cognitive-behavioural therapy improve disability, pain and quality of life of subjects with chronic neck pain: a randomized controlled trial with one-year follow-up.

    Science.gov (United States)

    Monticone, Marco; Ambrosini, Emilia; Rocca, Barbara; Cazzaniga, Daniele; Liquori, Valentina; Pedrocchi, Alessandra; Vernon, Howard

    2017-06-01

    To evaluate the effect of a group-based multidisciplinary rehabilitation programme on disability, pain and quality of life in subjects with chronic neck pain. Randomized controlled trial. Specialized rehabilitation centre. A total of 170 patients (mean age of 53 years (13); 121 females). The multidisciplinary group underwent a multidisciplinary rehabilitation programme combining multimodal exercises with psychologist-lead cognitive-behavioural therapy sessions. The general exercise group underwent general physiotherapy. Both groups followed group-based programmes once a week for ten weeks. Additionally, the multidisciplinary group met with the psychologist once a week for a 60-minute session. The Neck Disability Index (primary outcome), the Tampa Scale for Kinesiophobia, the Pain Catastrophizing Scale, a pain numerical rating scale and the Short-Form Health Survey. The participants were evaluated before, after training and after 12 months. A linear mixed model for repeated measures was used for each outcome measure. Significant effects ( p-value <0.001) were found over time and between groups for all outcome measures. After training, significant improvements were found for both groups for all outcome measures except kinesiophobia and catastrophizing, which did not change in the control group; however, the improvements were significantly greater for the multidisciplinary group. At 12-month follow-up a clinically meaningful between-group difference of 12.4 Neck Disability Index points was found for disability. A group-based multidisciplinary rehabilitation programme including cognitive-behavioural therapy was superior to group-based general physiotherapy in improving disability, pain and quality of life of subjects with chronic neck pain. The effects lasted for at least one year.

  8. A tracked approach for automated NMR assignments in proteins (TATAPRO)

    Energy Technology Data Exchange (ETDEWEB)

    Atreya, H.S.; Sahu, S.C.; Chary, K.V.R.; Govil, Girjesh [Tata Institute of Fundamental Research, Department of Chemical Sciences (India)

    2000-06-15

    experimental data on a calcium binding protein from Entamoeba histolytica (Eh-CaBP, 15 kDa) having substantial internal sequence homology and using published data on four other proteins in the molecular weight range of 18-42 kDa. In all the cases, nearly complete sequence specific resonance assignments (> 95%) are obtained. Furthermore, the reliability of the program has been tested by deleting sets of chemical shifts randomly from the master{sub l}ist created for the test proteins.

  9. Whole-grain wheat consumption reduces inflammation in a randomized controlled trial on overweight and obese subjects with unhealthy dietary and lifestyle behaviors: role of polyphenols bound to cereal dietary fiber.

    Science.gov (United States)

    Vitaglione, Paola; Mennella, Ilario; Ferracane, Rosalia; Rivellese, Angela A; Giacco, Rosalba; Ercolini, Danilo; Gibbons, Sean M; La Storia, Antonietta; Gilbert, Jack A; Jonnalagadda, Satya; Thielecke, Frank; Gallo, Maria A; Scalfi, Luca; Fogliano, Vincenzo

    2015-02-01

    Epidemiology associates whole-grain (WG) consumption with several health benefits. Mounting evidence suggests that WG wheat polyphenols play a role in mechanisms underlying health benefits. The objective was to assess circulating concentration, excretion, and the physiologic role of WG wheat polyphenols in subjects with suboptimal dietary and lifestyle behaviors. A placebo-controlled, parallel-group randomized trial with 80 healthy overweight/obese subjects with low intake of fruit and vegetables and sedentary lifestyle was performed. Participants replaced precise portions of refined wheat (RW) with a fixed amount of selected WG wheat or RW products for 8 wk. At baseline and every 4 wk, blood, urine, feces, and anthropometric and body composition measures were collected. Profiles of phenolic acids in biological samples, plasma markers of metabolic disease and inflammation, and fecal microbiota composition were assessed. WG consumption for 4-8 wk determined a 4-fold increase in serum dihydroferulic acid (DHFA) and a 2-fold increase in fecal ferulic acid (FA) compared with RW consumption (no changes). Similarly, urinary FA at 8 wk doubled the baseline concentration only in WG subjects. Concomitant reduction in plasma tumor necrosis factor-α (TNF-α) after 8 wk and increased interleukin (IL)-10 only after 4 wk with WG compared with RW (P = 0.04) were observed. No significant change in plasma metabolic disease markers over the study period was observed, but a trend toward lower plasma plasminogen activator inhibitor 1 with higher excretion of FA and DHFA in the WG group was found. Fecal FA was associated with baseline low Bifidobacteriales and Bacteroidetes abundances, whereas after WG consumption, it correlated with increased Bacteroidetes and Firmicutes but reduced Clostridium. TNF-α reduction correlated with increased Bacteroides and Lactobacillus. No effect of dietary interventions on anthropometric measurements and body composition was found. WG wheat

  10. The effects of d-amphetamine on extrastriatal dopamine D{sub 2}/D{sub 3} receptors: a randomized, double-blind, placebo-controlled PET study with [{sup 11}C]FLB 457 in healthy subjects

    Energy Technology Data Exchange (ETDEWEB)

    Aalto, Sargo [University of Turku, Turku PET Centre, Turku (Finland); Aabo Akademi University, Department of Psychology, Turku (Finland); Hirvonen, Jussi; Kajander, Jaana; Naagren, Kjell; Rinne, Juha O. [University of Turku, Turku PET Centre, Turku (Finland); Kaasinen, Valtteri [University of Turku, Department of Neurology, P.O. Box 52, Turku (Finland); Hagelberg, Nora [University of Turku, Turku PET Centre, Turku (Finland); Turku University Central Hospital, Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Medicine, Turku (Finland); Seppaelae, Timo [Drug Research Unit, National Public Health Institute, Helsinki (Finland); Scheinin, Harry [University of Turku, Turku PET Centre, Turku (Finland); University of Turku, Department of Pharmacology, Drug Development and Therapeutics, Turku (Finland); Hietala, Jarmo [University of Turku, Turku PET Centre, Turku (Finland); University of Turku, Department of Psychiatry, Turku (Finland)

    2009-03-15

    The dopamine D{sub 2}/D{sub 3} receptor ligand [{sup 11}C]FLB 457 and PET enable quantification of low-density extrastriatal D{sub 2}/D{sub 3} receptors, but it is uncertain whether [{sup 11}C]FLB 457 can be used for measuring extrastriatal dopamine release. We studied the effects of d-amphetamine (0.3 mg/kg i.v.) on extrastriatal [{sup 11}C]FLB 457 binding potential (BP{sub ND}) in a randomized, double-blind, placebo-controlled study including 24 healthy volunteers. The effects of d-amphetamine on [{sup 11}C]FLB 457 BP{sub ND} and distribution volume (V{sub T}) in the frontal cortex were not different from those of placebo. Small decreases in [{sup 11}C]FLB 457 BP{sub ND} were observed only in the posterior cingulate and hippocampus. The regional changes in [{sup 11}C]FLB 457 BP{sub ND} did not correlate with d-amphetamine-induced changes in subjective ratings of euphoria. This placebo-controlled study showed that d-amphetamine does not induce marked changes in measures of extrastriatal dopamine D{sub 2}/D{sub 3} receptor binding. Our results indicate that [{sup 11}C]FLB 457 PET is not a useful method for measuring extrastriatal dopamine release in humans. (orig.)

  11. Comparisons of the pharmacokinetics and tolerability of fixed-dose combinations of amlodipine besylate/losartan and amlodipine camsylate/losartan in healthy subjects: a randomized, open-label, single-dose, two-period, two-sequence crossover study

    Directory of Open Access Journals (Sweden)

    Choi Y

    2016-09-01

    Full Text Available YoonJung Choi,1 SeungHwan Lee,2 Sang-Min Cho,3 Won-Ho Kang,3 Kyu-Yeol Nam,4 In-Jin Jang,1 Kyung-Sang Yu1 1Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine, 2Clinical Trials Center, Seoul National University Hospital, 3Research Institute, 4Global R&D, Korea United Pharm Inc., Seoul, Republic of Korea Background: A fixed-dose combination (FDC of amlodipine and losartan has been used to reduce blood pressure in patients whose hypertension is not sufficiently controlled with either drug alone. The aim of this study was to evaluate the pharmacokinetic (PK characteristics and tolerability of an FDC of 6.94 mg amlodipine besylate (5 mg as amlodipine/50 mg losartan potassium compared to an FDC of 5 mg amlodipine camsylate/50 mg losartan potassium in healthy subjects. Subjects and methods: A randomized, open-label, single-dose, two-period, two-sequence crossover study was conducted on 46 healthy male subjects. Blood concentrations were measured by liquid chromatography–tandem mass spectrometry. Blood samples were collected up to 144 hours post dose for each period. PK parameters were calculated in each treatment group using a noncompartmental method. The 90% confidence intervals (CIs of the geometric mean ratios of the two treatments for the maximum plasma concentration (Cmax and the area under the concentration curve from time zero to the last quantifiable time point (AUC0–t were estimated. Tolerability assessments were performed for all subjects who received the drug at least once. Results: The PK profiles of the two treatments were similar. For amlodipine, the geometric mean ratios (90% CIs of amlodipine besylate to amlodipine camsylate for the Cmax and AUC0–t were 0.98 (0.94-1.01 and 0.97 (0.93-1.01, respectively. The corresponding values for losartan were 0.91 (0.81-1.02 and 1.05 (0.98-1.12, respectively. The incidence of adverse events was not significantly different between the two

  12. The 24-hour skin hydration and barrier function effects of a hyaluronic 1%, glycerin 5%, and Centella asiatica stem cells extract moisturizing fluid: an intra-subject, randomized, assessor-blinded study

    Directory of Open Access Journals (Sweden)

    Milani M

    2017-08-01

    Full Text Available Massimo Milani,1 Adele Sparavigna2 1Difa Cooper, Caronno Pertusella, Varese, 2Dermatologic Institute Dermig Milan, Milan, Italy Introduction: Moisturizing products are commonly used to improve hydration in skin dryness conditions. However, some topical hydrating products could have negative effects on skin barrier function. In addition, hydrating effects of moisturizers are not commonly evaluated up to 24 hours after a single application. Hyaluronic acid (HA and glycerin are very well-known substances able to improve skin hydration. Centella asiatica extract (CAE could exert lenitive, anti-inflammatory and reepithelialization actions. Furthermore, CAE could inhibit hyaluronidase enzyme activity, therefore prolonging the effect of HA. A fluid containing HA 1%, glycerin 5% and stem cells CAE has been recently developed (Jaluronius CS [JCS] fluid. Study aim: To evaluate and compare the 24-hour effects of JCS fluid on skin hydration and on transepidermal water loss (TEWL in healthy subjects in comparison with the control site. Subjects and methods: Twenty healthy women, mean age 40 years, were enrolled in an intra-subject (right vs left, randomized, assessor-blinded, controlled, 1-day trial. The primary end points were the skin hydration and TEWL, evaluated at the volar surface of the forearm and in standardized conditions (temperature- and humidity-controlled room: 23°C and 30% of humidity using a corneometer and a vapometer device at baseline, 1, 8 and 24 hours after JCS fluid application. Measurements were performed by an operator blinded for the treatments. Results: Skin hydration after 24 hours was significantly higher (P=0.001; Mann–Whitney U test in the JCS-treated area in comparison with the control site. JCS induced a significant (P=0.0001 increase in skin hydration at each evaluation time (+59% after 1 hour, +48% after 8 hours and +29% after 24 hours in comparison with both baseline (P=0.0001 and non-treated control site (P=0

  13. Nutrient-rich dairy proteins improve appendicular skeletal muscle mass and physical performance, and attenuate the loss of muscle strength in older men and women subjects: a single-blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Alemán-Mateo H

    2014-09-01

    Full Text Available Heliodoro Alemán-Mateo,1 Virginia Ramírez Carreón,1 Liliana Macías,1 Humberto Astiazaran-García,1 Ana Cristina Gallegos-Aguilar,1 José Rogelio Ramos Enríquez2 1Coordinación de Nutrición, Centro de Investigación en Alimentación y Desarrollo, A.C., 2Laboratorio de Análisis Clínicos e Investigación, Departamento de Ciencias Químico Biológicas, Universidad de Sonora, Hermosillo, Mexico Background: At present, it is unknown whether the use of nutrient-rich dairy proteins improves the markers of sarcopenia syndrome. Therefore, our proposal was to investigate whether ­adding 210 g of ricotta cheese daily would improve skeletal muscle mass, handgrip strength, and ­physical performance in non-sarcopenic older subjects.Subjects and methods: This was a single-blind randomized clinical trial that included two homogeneous, randomized groups of men and women over 60 years of age. Participants in the intervention group were asked to consume their habitual diet but add 210 g of ricotta cheese (IG/HD + RCH, while the control group was instructed to consume only their habitual diet (CG/HD. Basal and 12-week follow-up measurements included appendicular skeletal muscle mass (ASMM by dual-energy X-ray absorptiometry, handgrip strength by a handheld dynamometer, and physical performance using the short physical performance battery (SPPB and the stair-climb power test (SCPT. The main outcomes were relative changes in ASMM, strength, SPPB, and SCPT.Results: ASMM increased in the IG/HD + RCH (0.6±3.5 kg, but decreased in the CG/HD (–1.0±2.6. The relative change between groups was statistically significant (P=0.009. The relative change in strength in both groups was negative, but the loss of muscle strength was more pronounced in CG/HD, though in this regard statistical analysis found only a tendency (P=0.07. The relative change in the balance-test scores was positive for the IG/HD + RCH, while in the CG/HD it was negative, as those individuals had

  14. Assigning cause for sudden unexpected infant death.

    Science.gov (United States)

    Hunt, Carl E; Darnall, Robert A; McEntire, Betty L; Hyma, Bruce A

    2015-06-01

    We have reached a conundrum in assigning cause of death for sudden unexpected infant deaths. We summarize the discordant perspectives and approaches and how they have occurred, and recommend a pathway toward improved consistency. This lack of consistency affects pediatricians and other health care professionals, scientific investigators, medical examiners and coroners, law enforcement agencies, families, and support or advocacy groups. We recommend that an interdisciplinary international committee be organized to review current approaches for assigning cause of death, and to identify a consensus strategy for improving consistency. This effort will need to encompass intrinsic risk factors or infant vulnerability in addition to known environmental risk factors including unsafe sleep settings, and must be sufficiently flexible to accommodate a progressively expanding knowledge base.

  15. Solving Quadratic Assignment Problem with Fixed Assignment (QAPFA) using Branch and Bound Approach

    Science.gov (United States)

    Shuthairah Syed-Abdullah, Sharifah; Abdul-Rahman, Syariza; Mauziah Benjamin, Aida; Wibowo, Antoni; Ku-Mahamud, Ku-Ruhana

    2018-01-01

    Quadratic Assignment Problem (QAP) has been a very popular problem to be solved among researchers due to its practical applications. Several variants of QAP have been proposed by researchers in the past in order to reflect the real situations of QAP. One of the real problems of QAP is related with facilities which are required to be assigned to certain locations due to its function. In solving this problem, a fixed assignment has to be made thus allowing for the complexity of the problem to be reduced. Hence, this study introduces Quadratic Assignment Problem with Fixed Assignment (QAPFA) with the objective to minimize the assignment cost between the facility and location. This assignment takes into account the flow and distance between facility and location. QAPFA represents the real-world situation of the problem especially in dealing with specific requirement of some facilities to specific locations. Dataset of QAPFA is introduced and is solved using branch and bound approach. As for validation, the results of QAPFA are compared with QAP in terms of objective function and running time. The computational results show that the solution quality of QAPFA is lower when compared with the QAP, while the running time for QAPFA is lower than the QAP. Since the complexity of the problem is reduced by fixing the assignment, thus there is possibility that QAPFA has lower quality than QAP due to the fixed assignment. Nevertheless, in terms of running time QAPFA is better than QAP. It can be concluded that this problem reflect the real problem and practical to be used.

  16. Gender Assignment in Danish, Swedish and Norwegian: A Comparison of the Status of Assignment Criteria

    Directory of Open Access Journals (Sweden)

    Marcin Kilarski

    2004-01-01

    Full Text Available The paper deals with gender assignment of English loanwords in Danish, Swedish and Norwegian. The following assignment criteria have been analysed: semantic (animate, mass, phonological (number of syllables, homonymy, and morphological (inflection, suffixation, deverbal monosyllables, compounds. Common gender in Danish and Swedish and masculine in Norwegian are overrepresented in comparison with the native lexicon. This is confirmed by discriminant function analysis, which shows that neuter nouns in the three languages and feminine nouns in Norwegian show fewer characteristic features. This analysis has also been used to measure the degree of regularity based on the postulated criteria: the percentage of correctly classified cases (from 67% in Swedish to 68% in Norwegian and 72% in Danish suggests only a partial regularity in gender assignment. The stronger pull of common or masculine gender is reflected in the contribution of selected assignment rules, particularly in the assignment of animates, where common or masculine nouns constitute 96% of assigned nouns. As regards phonological rules, monosyllables show a slightly better correlation with neuter gender, particularly in Danish. Homonymy is significant for nouns of both genders in Danish, while in Swedish and Norwegian nouns with a native neuter or feminine homonym are more likely to be assigned common or masculine gender. Likewise, most inflectional and derivational assignment rules contribute to the assignment of common or masculine genders, with the exception of zero plurals, Swedish n-plurals, suffixes such as -ment, -ery, deverbal monosyllables in Danish and Norwegian, and compounds whose base appears in the corpus with n. gender. Discriminant function analysis shows that plural inflection has the greatest discriminant power among the postulated criteria. Finally, it is suggested that these tendencies may indicate an ongoing expansion of common and masculine genders in the three

  17. Assignments, Details, and Transfers: Overseas Service

    Science.gov (United States)

    2001-08-30

    contract will be served regardless of the prescribed tour length. This includes soldiers assigned to Technical Assistance Field Teams ( TAFTS ). r...PUERTO RICO (except as indicated) 36 24 2 Ponce (Ft Allen) and Isabela, Yauco, Cagus, Juana Diaz 36 18 Vieques Island NA 12 QATAR 24 12 40 AR 614–30...55AR 614–30 • 30 August 2001 TAADS The Army Authorization Document System TAFT Technical Assistance Field Team TAT turnaround time TDA table of

  18. Capacity constrained assignment in spatial databases

    DEFF Research Database (Denmark)

    U, Leong Hou; Yiu, Man Lung; Mouratidis, Kyriakos

    2008-01-01

    Given a point set P of customers (e.g., WiFi receivers) and a point set Q of service providers (e.g., wireless access points), where each q 2 Q has a capacity q.k, the capacity constrained assignment (CCA) is a matching M Q × P such that (i) each point q 2 Q (p 2 P) appears at most k times (at most...

  19. The adaptive approach for storage assignment by mining data of warehouse management system for distribution centres

    Science.gov (United States)

    Ming-Huang Chiang, David; Lin, Chia-Ping; Chen, Mu-Chen

    2011-05-01

    Among distribution centre operations, order picking has been reported to be the most labour-intensive activity. Sophisticated storage assignment policies adopted to reduce the travel distance of order picking have been explored in the literature. Unfortunately, previous research has been devoted to locating entire products from scratch. Instead, this study intends to propose an adaptive approach, a Data Mining-based Storage Assignment approach (DMSA), to find the optimal storage assignment for newly delivered products that need to be put away when there is vacant shelf space in a distribution centre. In the DMSA, a new association index (AIX) is developed to evaluate the fitness between the put away products and the unassigned storage locations by applying association rule mining. With AIX, the storage location assignment problem (SLAP) can be formulated and solved as a binary integer programming. To evaluate the performance of DMSA, a real-world order database of a distribution centre is obtained and used to compare the results from DMSA with a random assignment approach. It turns out that DMSA outperforms random assignment as the number of put away products and the proportion of put away products with high turnover rates increase.

  20. Gut microbiota mediated benefits of barley kernel products on metabolism, gut hormones, and inflammatory markers as affected by co-ingestion of commercially available probiotics: a randomized controlled study in healthy subjects.

    Science.gov (United States)

    Nilsson, Anne; Johansson-Boll, Elin; Sandberg, Jonna; Björck, Inger

    2016-10-01

    Barley kernel based products have been shown to induce benefits on blood glucose regulation, cardio-metabolic risk markers and appetite regulating hormones in a time perspective of 11-16 h after intake. The mechanisms have been assigned to gut fermentation of indigestible carbohydrates. The purpose of the present study was to evaluate if the modulatory effects of barley on markers of metabolic- and appetite regulation are affected by a dietary background including a mixture of commercially available probiotics. Barley kernel bread was included in the normal diet of 21 healthy subjects in two 4-day intervention periods; with (BB-pro) or without (BB) dietary supplement with a combination of probiotics (Bifidobacterium animalis DN-173 010, Lactobacillus reuteri DSM 17938, and Lactobacillus plantarum 299v). A white wheat flour based bread was included as a reference product (WWB-ref) in a separate 4-day bread intervention period. A cross-over design was applied concerning BB- and WWB-ref; the BB-pro intervention was last in the test sequence. The BB-pro intervention was preceded by 10 days priming with probiotics. The 4 day BB- and WWB-ref intervention periods included dietary supplementation with placebo, and the interventions were preceded with 10 days priming with the placebo. The day after each intervention period, blood samples were collected at fasting and postprandially after a standardized breakfast (0-210 min) for determination of markers of glucose metabolism (blood glucose, serum (s-) insulin), inflammation (s-IL-6, s-IL-18, s-CRP, PAI-1), and concentrations of gut derived hormones involved in satiety and glucose homeostasis (plasma (p-) PYY, p-GLP-1) and intestinal barrier integrity (p-GLP-2). Breath hydrogen was determined as a marker of colonic fermentation. Four days intervention with BB, in comparison to WWB-ref, lowered blood glucose response after a subsequent standardized breakfast (0-210 min, P probiotics did not affect the metabolic outcome of

  1. Assignment and Correspondence Tracking System - Tactical / Operational Reporting

    Data.gov (United States)

    Social Security Administration — Reporting data store for the Assignment and Correspondence Tracking System (ACT). ACT automates the assignment and tracking of correspondence processing within the...

  2. High-Frequency Percussive Ventilation and Low Tidal Volume Ventilation in Burns: A Randomized Controlled Trial

    Science.gov (United States)

    2010-01-01

    care units, high-frequency percussive ventilation is preferentially used to provide mechanical ventilation in support of patients with acute lung... mechanical ventilation were admitted to the burn intensive care unit. The study was conducted over a 3-yr period between April 2006 and May 2009. This trial...was registered with ClinicalTrials.gov as NCT00351741. Interventions: Subjects were randomly assigned to receive mechanical ventilation through a high

  3. Salacia Extract Improves Postprandial Glucose and Insulin Response: A Randomized Double-Blind, Placebo Controlled, Crossover Study in Healthy Volunteers

    Directory of Open Access Journals (Sweden)

    Shankaranarayanan Jeykodi

    2016-01-01

    Full Text Available Thirty-five healthy subjects were randomly assigned to different doses of Salacia chinensis extract (200 mg, 300 mg, and 500 mg SCE capsules and compared with placebo. It is a placebo controlled randomized crossover design study. Subjects were given oral sucrose solution along with capsules and plasma glucose and insulin responses were analyzed. Blood samples were collected at 0, 30, 60, 90, 120, and 180 minutes after administration. AUC insulin significantly lowered after ingestion of SCE. No significant adverse events were observed. Reducing glucose and insulin is very important in reducing postprandial hyperglycemia.

  4. A combined strategy for solving quadratic assignment problem

    Science.gov (United States)

    Ahyaningsih, Faiz

    2017-08-01

    The quadratic assignment problem is a combinatorial problem of deciding the placement of facilities in specified locations in such a way as to minimize a nonconvex objective function expressed in terms of flow between facilities, and distance between location. Due to the non-convexity nature of the problem, therefore to get a `good' starting point is necessary in order to obtain a better optimal solution. In this paper we propose a combined strategy (random point strategy to get initial starting point and then use forward exchange strategy and backward exchange strategy to get `optimal' solution). As a computational experience we've solved the problem of Esc 16b, Esc 16c and Esc 16h from QAPLIB. Finally, we present a comparative study between Combined Strategy and Data -Guided Lexisearch Algorithm. The computational study shows the effectiveness of our proposed combined strategy.

  5. Game theoretic target assignment approach in ballistic missile defense

    Science.gov (United States)

    Wei, Mo; Chen, Genshe; Pham, Khanh; Blasch, Erik; Wu, Yingli

    2008-04-01

    In this paper, both Pareto game theory and learning theory algorithms are utilized in a resource management module for a practical missile interception system. The resource management module will determine how many and which antimissiles will be launched for interception. Such interception decisions are based on the number of invading missiles, availability of antimissiles, special capability of antimissiles, and realistic constraints on the movements of both invading missiles and antimissiles such as minimum turning radius, maximum velocity, fuel range, etc. Simulations demonstrate performance improvements when compared to existing strategies (i.e. random assignment), independent of guidance laws (i.e. Proportional Navigation (PN) or the Differential-Game-based Guidance Law (DGL) guidance laws) under end-game interception cases or midcourse interception situations.

  6. Evaluation of the pharmacoDYNAMIC effects of riociguat in subjects with pulmonary hypertension and heart failure with preserved ejection fraction : Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Mascherbauer, Julia; Grünig, Ekkehard; Halank, Michael; Hohenforst-Schmidt, Wolfgang; Kammerlander, Andreas A; Pretsch, Ingrid; Steringer-Mascherbauer, Regina; Ulrich, Silvia; Lang, Irene M; Wargenau, Manfred; Frey, Reiner; Bonderman, Diana

    2016-12-01

    The presence of pulmonary hypertension (PH) severely aggravates the clinical course of heart failure with preserved ejection fraction (HFPEF) resulting in substantial morbidity and mortality. So far, neither established heart failure therapies nor pulmonary vasodilators have proven to be effective for this condition. Riociguat (Adempas®, BAY 63-2521), a stimulator of soluble guanylate cyclase, is a novel pulmonary and systemic vasodilator that has been approved for the treatment of precapillary forms of PH. With regard to postcapillary PH, the DILATE-1 study was a multicenter, double-blind, randomized, placebo-controlled single-dose study in subjects with PH associated with HFPEF. Although there was no significant change in the primary outcome measure, peak decrease in mean pulmonary artery pressure with riociguat versus placebo, riociguat significantly increased stroke volume without changing heart rate, pulmonary artery wedge pressure, transpulmonary pressure gradient or pulmonary vascular resistance. The present study is designed to test the efficacy of long-term treatment with riociguat in patients with PH associated with HFPEF. The DYNAMIC study is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical phase IIb trial evaluating the efficacy, safety and kinetics of riociguat in PH-HFPEF patients. The drug will be given over 26 weeks to evaluate the effects of riociguat versus placebo. The primary efficacy variable will be the change from baseline in cardiac output at rest, measured by right heart catheter after 26 weeks of study drug treatment. Additional efficacy variables will be changes from baseline in further hemodynamic parameters, changes in left and right atrial area, right ventricular volume, as well as right ventricular ejection fraction measured by cardiac magnetic resonance imaging, and changes from baseline in World Health Organization (WHO) class and N‑terminal prohormone B‑type natriuretic peptide (NT

  7. Optimisation of timetable-based, stochastic transit assignment models based on MSA

    DEFF Research Database (Denmark)

    Nielsen, Otto Anker; Frederiksen, Rasmus Dyhr

    2006-01-01

    Public transport assignment models have increased in complexity in order to describe passengers' route choices as detailed and correctly as possible. Important trends in the development are (1) timetable-based assignment, (2) inclusion of feeder modes, (3) use of stochastic components to describe...... differences in passengers' preferences within and between purposes and classes (random coefficients), as well as to describe non-explained variation within a utility theory framework, and (4) consideration of capacity problems at coach level, system level and terminal level. In the Copenhagen-Ringsted Model...... (CRM), such a large-scale transit assignment model was developed and estimated. The Stochastic User Equilibrium problem was solved by the Method of Successive Averages (MSA). However, the model suffered from very large calculation times. The paper focuses on how to optimise transit assignment models...

  8. Efficacy and safety characteristics of mometasone furoate/formoterol fumarate fixed-dose combination in subjects with moderate to very severe COPD: findings from pooled analysis of two randomized, 52-week placebo-controlled trials

    Directory of Open Access Journals (Sweden)

    Tashkin DP

    2012-02-01

    Full Text Available Donald P Tashkin1, Dennis E Doherty2, Edward Kerwin3, Carlos E Matiz-Bueno4, Barbara Knorr5, Tulin Shekar5, Davis Gates5, Heribert Staudinger51David Geffen School of Medicine at UCLA, Los Angeles, CA, 2Division of Pulmonary, Critical Care, and Sleep Medicine, University of Kentucky, Lexington, KY, 3Clinical Research Institute of Southern Oregon, Medford, OR, USA; 4Fundación Salud Bosque, Bogota, Colombia, 5Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USABackground: The clinical efficacy and safety of a mometasone furoate/formoterol fumarate (MF/F fixed-dose combination formulation administered via a metered-dose inhaler was investigated in patients with moderate to very severe chronic obstructive pulmonary disease (COPD.Methods: Two 52-week, multicenter, double-blind, placebo-controlled trials with identical study designs were conducted in current or ex-smokers (aged ≥40 years, and pooled study results are presented herein. Subjects (n = 2251 were randomized to 26 weeks of twice-daily treatment with MF/F 400/10 µg, MF/F 200/10 µg, MF 400 µg, F 10 µg, or placebo. After the 26-week treatment period, placebo subjects completed the trial and 75% of subjects on active treatment entered a 26-week safety extension. Coprimary efficacy variables were mean changes in forced expiratory volume in one second (FEV1, area under the curve from 0 to 12 hours postdose (AUC0–12 h, and morning predose/trough FEV1 from baseline to the week 13 endpoint. Key secondary efficacy variables were St George’s Respiratory Questionnaire scores, symptom-free nights, time-to-first exacerbation, and partly stable COPD at the week 26 endpoint.Results: In the 26-week treatment period, significantly greater increases in FEV1 AUC0–12 h occurred with MF/F 400/10 versus MF 400 and placebo at the week 13 and week 26 endpoints (P ≤ 0.032. These increases were over three-fold greater with MF/F 400/10 than with MF 400. Also, significantly greater increases in morning

  9. Randomized controlled trial of mindfulness-based stress reduction (MBSR) for survivors of breast cancer.

    Science.gov (United States)

    Lengacher, Cecile A; Johnson-Mallard, Versie; Post-White, Janice; Moscoso, Manolete S; Jacobsen, Paul B; Klein, Thomas W; Widen, Raymond H; Fitzgerald, Shirley G; Shelton, Melissa M; Barta, Michelle; Goodman, Matthew; Cox, Charles E; Kip, Kevin E

    2009-12-01

    Considerable morbidity persists among survivors of breast cancer (BC) including high levels of psychological stress, anxiety, depression, fear of recurrence, and physical symptoms including pain, fatigue, and sleep disturbances, and impaired quality of life. Effective interventions are needed during this difficult transitional period. We conducted a randomized controlled trial of 84 female BC survivors (Stages 0-III) recruited from the H. Lee Moffitt Cancer and Research Institute. All subjects were within 18 months of treatment completion with surgery and adjuvant radiation and/or chemotherapy. Subjects were randomly assigned to a 6-week Mindfulness-Based Stress Reduction (MBSR) program designed to self-regulate arousal to stressful circumstances or symptoms (n=41) or to usual care (n=43). Outcome measures compared at 6 weeks by random assignment included validated measures of psychological status (depression, anxiety, perceived stress, fear of recurrence, optimism, social support) and psychological and physical subscales of quality of life (SF-36). Compared with usual care, subjects assigned to MBSR(BC) had significantly lower (two-sided pMBSR tended to experience greater improvements in measures of energy and physical functioning. Among BC survivors within 18 months of treatment completion, a 6-week MBSR(BC) program resulted in significant improvements in psychological status and quality of life compared with usual care.

  10. Efficacy and tolerability of taspoglutide versus pioglitazone in subjects with type 2 diabetes uncontrolled with sulphonylurea or sulphonylurea-metformin therapy: a randomized, double-blind study (T-emerge 6).

    Science.gov (United States)

    Pratley, R E; Urosevic, D; Boldrin, M; Balena, R

    2013-03-01

    This study compared the efficacy and tolerability of taspoglutide versus pioglitazone in subjects with type 2 diabetes inadequately controlled with sulphonylurea ± metformin. In this double-blind, double-dummy, parallel-group trial, 760 subjects (49% male, age 56.4 years, diabetes duration 8.8 years, body mass index 32.7 kg/m(2) and haemoglobin A1c [HbA1c] 8.3%) were randomized (1 : 1 : 1) to subcutaneous injections of taspoglutide 10 or 20 mg once weekly or oral pioglitazone 45 mg daily. The primary endpoint was change in HbA1c after 24 weeks. Mean (±s.e.) HbA1c reductions with taspoglutide 10 (-1.18 ± 0.08%) and 20 mg (-1.36 ± 0.08%) were non-inferior to pioglitazone (-1.30 ± 0.08%) (p = 0.21 and 0.37, respectively); mean treatment differences were 0.12 (95% confidence interval: -0.03, -0.26) and -0.06 (-0.20, 0.08) for taspoglutide 10 and 20 mg versus pioglitazone. Mean (±s.e.) changes in body weight (kg) were -0.8 ± 0.3, -1.0 ± 0.3 and 3.6 ± 0.3 for taspoglutide 10 and 20 mg and pioglitazone, respectively; 8, 11 and 1% of patients achieved ≥5% weight loss. A higher incidence of adverse events (AEs) occurred with taspoglutide, predominantly gastrointestinal disturbances and injection-site reactions, resulting in higher rates of discontinuation versus pioglitazone. No treatment differences in serious AEs were observed. Taspoglutide offered good glycaemic control similar to pioglitazone, while achieving beneficial weight loss rather than weight gain, but was associated with more AEs. Due to the higher than expected discontinuation rates, mainly because of gastrointestinal intolerability, the taspoglutide clinical programme was stopped. © 2012 Blackwell Publishing Ltd.

  11. A randomized, double-blind, placebo-, and positive-controlled clinical pilot study to evaluate the efficacy and tolerability of standardized aqueous extracts of Terminalia chebula and Terminalia bellerica in subjects with hyperuricemia

    Directory of Open Access Journals (Sweden)

    Usharani P

    2016-06-01

    Full Text Available Pingali Usharani,1 Chandrasekhar Nutalapati,1 Venkata Kishan Pokuri,1 Chiranjeevi Uday Kumar,1 Gangadhar Taduri,21Department of Clinical Pharmacology and Therapeutics, 2Department of Nephrology, Nizam's Institute of Medical Sciences, Panjagutta, Hyderabad, India Objectives: To evaluate the efficacy and tolerability of standardized aqueous extracts of Terminalia chebula and Terminalia bellerica versus febuxostat and placebo on reduction in serum uric acid levels in subjects with hyperuricemia. Materials and methods: A total of 110 eligible subjects with hyperuricemia were enrolled and randomized to either of the five treatment groups – T. chebula 500 mg twice a day (BID, T. bellerica 250 mg BID, T. bellerica 500 mg BID, placebo BID, and febuxostat 40 mg once daily plus an identical placebo – for a duration of 24 weeks. Serum uric acid levels were measured at baseline and at the end of 4, 8, 12, 16, 20, and 24 weeks. Statistical analysis was done using GraphPad Prism Software 4. Results and interpretation: All active treatment groups showed a reduction in serum uric acid levels compared to baseline and placebo. Significant reduction in mean serum uric acid levels started as early as 4 weeks following treatment, compared to baseline, with T. bellerica (500 and 250 mg, febuxostat (P<0.001, and T. chebula 500 mg (P<0.01; an increase in serum uric acid levels was seen with placebo (P<0.05. The serum uric acid levels became steady after 16 weeks of treatment and remained the same until the end of 24 weeks. The reduction of serum uric acid levels in the T. bellerica 500 mg group was nearly twice that of the T. chebula 500 mg group as well as T. bellerica 250 mg group at all time points. T. bellerica 500 mg reduced serum uric acid levels from 8.07±0.87 to 5.78±0.25 compared to febuxostat, which reduced serum uric acid levels from 8.53±0.97 to 4.28±0.67 (P<0.001 at the end of 24 weeks. The efficacy of T. bellerica appeared to be dose dependent

  12. Differential acute postprandial effects of processed meat and isocaloric vegan meals on the gastrointestinal hormone response in subjects suffering from type 2 diabetes and healthy controls: a randomized crossover study.

    Directory of Open Access Journals (Sweden)

    Lenka Belinova

    Full Text Available The intake of meat, particularly processed meat, is a dietary risk factor for diabetes. Meat intake impairs insulin sensitivity and leads to increased oxidative stress. However, its effect on postprandial gastrointestinal hormone (GIH secretion is unclear. We aimed to investigate the acute effects of two standardized isocaloric meals: a processed hamburger meat meal rich in protein and saturated fat (M-meal and a vegan meal rich in carbohydrates (V-meal. We hypothesized that the meat meal would lead to abnormal postprandial increases in plasma lipids and oxidative stress markers and impaired GIH responses.In a randomized crossover study, 50 patients suffering from type 2 diabetes (T2D and 50 healthy subjects underwent two 3-h meal tolerance tests. For statistical analyses, repeated-measures ANOVA was performed.The M-meal resulted in a higher postprandial increase in lipids in both groups (p<0.001 and persistent postprandial hyperinsulinemia in patients with diabetes (p<0.001. The plasma glucose levels were significantly higher after the V-meal only at the peak level. The plasma concentrations of glucose-dependent insulinotropic peptide (GIP, peptide tyrosine-tyrosine (PYY and pancreatic polypeptide (PP were higher (p<0.05, p<0.001, p<0.001, respectively and the ghrelin concentration was lower (p<0.001 after the M-meal in healthy subjects. In contrast, the concentrations of GIP, PYY and PP were significantly lower after the M-meal in T2D patients (p<0.001. Compared with the V-meal, the M-meal was associated with a larger increase in lipoperoxidation in T2D patients (p<0.05.Our results suggest that the diet composition and the energy content, rather than the carbohydrate count, should be important considerations for dietary management and demonstrate that processed meat consumption is accompanied by impaired GIH responses and increased oxidative stress marker levels in diabetic patients.ClinicalTrials.gov NCT01572402.

  13. The non-alcoholic fraction of beer increases stromal cell derived factor 1 and the number of circulating endothelial progenitor cells in high cardiovascular risk subjects: a randomized clinical trial.

    Science.gov (United States)

    Chiva-Blanch, Gemma; Condines, Ximena; Magraner, Emma; Roth, Irene; Valderas-Martínez, Palmira; Arranz, Sara; Casas, Rosa; Martínez-Huélamo, Miriam; Vallverdú-Queralt, Anna; Quifer-Rada, Paola; Lamuela-Raventos, Rosa M; Estruch, Ramon

    2014-04-01

    Moderate alcohol consumption is associated with a decrease in cardiovascular risk, but fermented beverages seem to confer greater cardiovascular protection due to their polyphenolic content. Circulating endothelial progenitor cells (EPC) are bone-marrow-derived stem cells with the ability to repair and maintain endothelial integrity and function and are considered as a surrogate marker of vascular function and cumulative cardiovascular risk. Nevertheless, no study has been carried out on the effects of moderate beer consumption on the number of circulating EPC in high cardiovascular risk patients. To compare the effects of moderate consumption of beer, non-alcoholic beer and gin on the number of circulating EPC and EPC-mobilizing factors. In this crossover trial, 33 men at high cardiovascular risk were randomized to receive beer (30 g alcohol/d), the equivalent amount of polyphenols in the form of non-alcoholic beer, or gin (30 g alcohol/d) for 4 weeks. Diet and physical exercise were carefully monitored. The number of circulating EPC and EPC-mobilizing factors were determined at baseline and after each intervention. After the beer and non-alcoholic beer interventions, the number of circulating EPC significantly increased by 8 and 5 units, respectively, while no significant differences were observed after the gin period. In correlation, stromal cell derived factor 1 increased significantly after the non-alcoholic and the beer interventions. The non-alcoholic fraction of beer increases the number of circulating EPC in peripheral blood from high cardiovascular risk subjects. http://www.controlled-trials.com/ISRCTN95345245 ISRCTN95345245. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  14. Structural Encoding of Static Single Assignment Form

    DEFF Research Database (Denmark)

    Gal, Andreas; Probst, Christian; Franz, Michael

    2005-01-01

    Static Single Assignment (SSA) form is often used as an intermediate representation during code optimization in Java Virtual Machines. Recently, SSA has successfully been used for bytecode verification. However, constructing SSA at the code consumer is costly. SSAbased mobile code transport formats...... have been shown to eliminate this cost by shifting SSA creation to the code producer. These new formats, however, are not backward compatible with the established Java class-file format. We propose a novel approach to transport SSA information implicitly through structural code properties of standard...

  15. Characteristic ratio assignment in fractional order systems.

    Science.gov (United States)

    Tabatabaei, Mohammad; Haeri, Mohammad

    2010-10-01

    In this paper the characteristic ratios and generalized time constant are defined for all-pole commensurate fractional orde