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  1. 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.

  2. 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...

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

    Directory of Open Access Journals (Sweden)

    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

  4. Effect of Short-Term Fasting on Systemic Cytochrome P450-Mediated Drug Metabolism in Healthy Subjects: A Randomized, Controlled, Crossover Study Using a Cocktail Approach

    NARCIS (Netherlands)

    Lammers, Laureen A.; Achterbergh, Roos; van Schaik, Ron H. N.; Romijn, Johannes A.; Mathôt, Ron A. A.

    2017-01-01

    Short-term fasting can alter drug exposure but it is unknown whether this is an effect of altered oral bioavailability and/or systemic clearance. Therefore, the aim of our study was to assess the effect of short-term fasting on oral bioavailability and systemic clearance of different drugs. In a

  5. Effect of Short-Term Fasting on Systemic Cytochrome P450-Mediated Drug Metabolism in Healthy Subjects: A Randomized, Controlled, Crossover Study Using a Cocktail Approach

    NARCIS (Netherlands)

    L.A. Lammers (Laureen); Achterbergh, R. (Roos); R.H.N. van Schaik (Ron); J.A. Romijn (Johannes); R.A. Mathot (Ron)

    2017-01-01

    textabstractBackground and Objective: Short-term fasting can alter drug exposure but it is unknown whether this is an effect of altered oral bioavailability and/or systemic clearance. Therefore, the aim of our study was to assess the effect of short-term fasting on oral bioavailability and systemic

  6. 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.

  7. 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...

  8. Random walk term weighting for information retrieval

    DEFF Research Database (Denmark)

    Blanco, R.; Lioma, Christina

    2007-01-01

    We present a way of estimating term weights for Information Retrieval (IR), using term co-occurrence as a measure of dependency between terms.We use the random walk graph-based ranking algorithm on a graph that encodes terms and co-occurrence dependencies in text, from which we derive term weights...... that represent a quantification of how a term contributes to its context. Evaluation on two TREC collections and 350 topics shows that the random walk-based term weights perform at least comparably to the traditional tf-idf term weighting, while they outperform it when the distance between co-occurring terms...

  9. 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…

  10. 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…

  11. 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.

  12. 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....

  13. 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.

  14. 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...

  15. LONG TERM EFFECT OF CYRIAX PHYSIOTHERPY WITH SUPERVISED EXERCISE PROGRAM IN SUBJECTS WITH TENNIS ELBOW

    Directory of Open Access Journals (Sweden)

    Pallavi Shridhar Thakare

    2014-06-01

    Full Text Available Background: The purpose is to find long term effect of Cyriax physiotherapy with supervised exercise program in the reduction of pain and improvement of functional ability for subjects with tennis elbow. Method: An experimental study design, 30 subjects with Tennis Elbow randomized 15 subjects each into Study and Control group. Control group received Supervised Exercise program while Study group received Cyriax Physiotherapy with Supervised exercises program thrice in a week for 4 weeks and post intervention follow up after 2 weeks. Outcome measurements were measured for pain using Visual analogue Scale (VAS and Patient Rated Tennis Elbow Evaluation (PRTEE for functional ability. Results: There is no statistically significant difference in pre- intervention means of VAS and PRTEE when compared between the groups using independent ‘t’ test as a parametric and Mann Whitney U test as a non-parametric test. When means of post intervention and follow-up measurements were compared there is a statistically significant (p<0.05 difference in VAS and PRTEE scores between the groups. However greater percentage of improvements was obtained in study group than control group. Conclusion: It is concluded that there is significant long term effect with greater percentage of improvement in pain and functional ability up to 2 weeks follow-up following 4 weeks of combined Cyriax physiotherapy with supervised exercise program than only supervised exercise program for subjects with tennis elbow.

  16. Short-term interval training alters brain glucose metabolism in subjects with insulin resistance.

    Science.gov (United States)

    Honkala, Sanna M; Johansson, Jarkko; Motiani, Kumail K; Eskelinen, Jari-Joonas; Virtanen, Kirsi A; Löyttyniemi, Eliisa; Knuuti, Juhani; Nuutila, Pirjo; Kalliokoski, Kari K; Hannukainen, Jarna C

    2017-01-01

    Brain insulin-stimulated glucose uptake (GU) is increased in obese and insulin resistant subjects but normalizes after weight loss along with improved whole-body insulin sensitivity. Our aim was to study whether short-term exercise training (moderate intensity continuous training (MICT) or sprint interval training (SIT)) alters substrates for brain energy metabolism in insulin resistance. Sedentary subjects ( n = 21, BMI 23.7-34.3 kg/m2, age 43-55 y) with insulin resistance were randomized into MICT ( n = 11, intensity≥60% of VO2peak) or SIT ( n = 10, all-out) groups for a two-week training intervention. Brain GU during insulin stimulation and fasting brain free fatty acid uptake (FAU) was measured using PET. At baseline, brain GU was positively associated with the fasting insulin level and negatively with the whole-body insulin sensitivity. The whole-body insulin sensitivity improved with both training modes (20%, p = 0.007), while only SIT led to an increase in aerobic capacity (5%, p = 0.03). SIT also reduced insulin-stimulated brain GU both in global cortical grey matter uptake (12%, p = 0.03) and in specific regions ( p Brain FAU remained unchanged after the training in both groups. These findings show that short-term SIT effectively decreases insulin-stimulated brain GU in sedentary subjects with insulin resistance.

  17. LONG-TERM VARIABILITY OF BRONCHIAL RESPONSIVENESS TO HISTAMINE IN A RANDOM-POPULATION SAMPLE OF ADULTS

    NARCIS (Netherlands)

    RIJCKEN, B; SCHOUTEN, JP; WEISS, ST; ROSNER, B; DEVRIES, K; VANDERLENDE, R

    1993-01-01

    Long-term variability of bronchial responsiveness has been studied in a random population sample of adults. During a follow-up period of 18 yr, 2,216 subjects contributed 5,012 observations to the analyses. Each subject could have as many as seven observations. Bronchial responsiveness was assessed

  18. 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.

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

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    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

  20. 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

  1. 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

  2. 38 CFR 17.258 - Terms and conditions to which awards are subject.

    Science.gov (United States)

    2010-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 1 2010-07-01 2010-07-01 false Terms and conditions to which awards are subject. 17.258 Section 17.258 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS MEDICAL Grants for Exchange of Information § 17.258 Terms and conditions to which awards...

  3. Subjectivity

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    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. 

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

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    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.

  5. 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.

  6. 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.

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

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    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.

  8. Antibiotic prophylaxis for term or near-term premature rupture of membranes: metaanalysis of randomized trials.

    Science.gov (United States)

    Saccone, Gabriele; Berghella, Vincenzo

    2015-05-01

    The objective of the study was to evaluate the efficacy of antibiotic prophylaxis in women with term or near-term premature rupture of membranes. Searches were performed in MEDLINE, OVID, Scopus, ClinicalTrials.gov, the PROSPERO International Prospective Register of Systematic Reviews, EMBASE, ScienceDirect.com, MEDSCAPE, and the Cochrane Central Register of Controlled Trials with the use of a combination of key words and text words related to antibiotics, premature rupture of membranes, term, and trials from inception of each database to September 2014. We included all randomized trials of singleton gestations with premature rupture of membranes at 36 weeks or more, who were randomized to antibiotic prophylaxis or control (either placebo or no treatment). The primary outcomes included maternal chorioamnionitis and neonatal sepsis. A subgroup analysis on studies with latency more than 12 hours was planned. Before data extraction, the review was registered with the PROSPERO International Prospective Register of Systematic Reviews (registration number CRD42014013928). The metaanalysis was performed following the Preferred Reporting Item for Systematic Reviews and Meta-analyses statement. Women who received antibiotics had the same rate of chorioamnionitis (2.7% vs 3.7%; relative risk [RR], 0.73, 95% confidence interval [CI], 0.48-1.12), endometritis (0.4% vs 0.9%; RR, 0.44, 95% CI, 0.18-1.10), maternal infection (3.1% vs 4.6%; RR, 0.48, 95% CI, 0.19-1.21), and neonatal sepsis (1.0% vs 1.4%; RR, 0.69, 95% CI, 0.34-1.39). In the planned subgroup analysis, women with latency longer than 12 hours, who received antibiotics, had a lower rate of chorioamnionitis (2.9% vs 6.1%; RR, 0.49, 95% CI, 0.27-0.91) and endometritis (0% vs 2.2%; RR, 0.12, 95% CI, 0.02-0.62) compared with the control group. Antibiotic prophylaxis for term or near-term premature rupture of membranes is not associated with any benefits in either maternal or neonatal outcomes. In women with latency longer

  9. Short term effects of kinesiotaping on acromiohumeral distance in asymptomatic subjects: a randomised controlled trial.

    Science.gov (United States)

    Luque-Suarez, A; Navarro-Ledesma, S; Petocz, P; Hancock, M J; Hush, J

    2013-12-01

    The first aim of this study was to investigate whether kinesiotaping (KT) can increase the acromiohumeral distance (AHD) in asymptomatic subjects in the short term. The second aim was to investigate whether the direction of kinesiotaping application influences AHD. In recent years, the use of KT has become increasingly popular for a range of musculoskeletal conditions and for sport injuries. To date, we are unaware of any research investigating the effect of kinesiotaping on AHD. Moreover, it is unknown whether the direction of kinesiotaping application for the shoulder is important. Forty nine participants were randomly assigned to one of three groups: kinesiotaping group 1 (KT1), kinesiotaping group 2 (KT2) and sham kinesiotaping (KT3). AHD ultrasound measurements at 0° and 60° of shoulder elevation were collected at baseline and immediately after kinesiotape application. The results showed significant improvements in AHD after kinesiotaping, compared with sham taping. The mean difference in AHD between KT1 and KT3 groups was 1.28 mm (95% CI: 0.55, 2.03), and between KT2 and KT3 was 0.98 mm (95% CI: 0.23, 1.74). Comparison of KT1 and KT2 groups, which was performed to identify whether the direction of taping influences the AHD, indicated there were no significant differences. KT increases AHD in healthy individuals immediately following application, compared with sham kinesiotape. No differences were found with respect to the direction in which KT was applied. Copyright © 2013 Elsevier Ltd. All rights reserved.

  10. 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.

  11. Open quantum random walk in terms of quantum Bernoulli noise

    Science.gov (United States)

    Wang, Caishi; Wang, Ce; Ren, Suling; Tang, Yuling

    2018-03-01

    In this paper, we introduce an open quantum random walk, which we call the QBN-based open walk, by means of quantum Bernoulli noise, and study its properties from a random walk point of view. We prove that, with the localized ground state as its initial state, the QBN-based open walk has the same limit probability distribution as the classical random walk. We also show that the probability distributions of the QBN-based open walk include those of the unitary quantum walk recently introduced by Wang and Ye (Quantum Inf Process 15:1897-1908, 2016) as a special case.

  12. 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.

  13. Dyslipidemia in HIV-1 Infected Subjects with Short Term Usage of ...

    African Journals Online (AJOL)

    Dyslipidemia in HIV-1 Infected Subjects with Short Term Usage of Highly Active Antiretroviral Therapy (HAART) in Benin City, Nigeria. O. G. Igharo, T.L. Olawoye, H.B. Osadolor, F. A. Idomeh, O. J. Osunbor, A. O. Osagie, O.C. Iyamu ...

  14. 37 CFR 1.710 - Patents subject to extension of the patent term.

    Science.gov (United States)

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Patents subject to extension of the patent term. 1.710 Section 1.710 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES Adjustment and Extension...

  15. Leveraging output term co-occurrence frequencies and latent associations in predicting medical subject headings.

    Science.gov (United States)

    Kavuluru, Ramakanth; Lu, Yuan

    2014-11-01

    Trained indexers at the National Library of Medicine (NLM) manually tag each biomedical abstract with the most suitable terms from the Medical Subject Headings (MeSH) terminology to be indexed by their PubMed information system. MeSH has over 26,000 terms and indexers look at each article's full text while assigning the terms. Recent automated attempts focused on using the article title and abstract text to identify MeSH terms for the corresponding article. Most of these approaches used supervised machine learning techniques that use already indexed articles and the corresponding MeSH terms. In this paper, we present a new indexing approach that leverages term co-occurrence frequencies and latent term associations computed using MeSH term sets corresponding to a set of nearly 18 million articles already indexed with MeSH terms by indexers at NLM. The main goal of our study is to gauge the potential of output label co-occurrences, latent associations, and relationships extracted from free text in both unsupervised and supervised indexing approaches. In this paper, using a novel and purely unsupervised approach, we achieve a micro-F-score that is comparable to those obtained using supervised machine learning techniques. By incorporating term co-occurrence and latent association features into a supervised learning framework, we also improve over the best results published on two public datasets.

  16. The Severe Respiratory Insufficiency Questionnaire for Subjects With COPD With Long-Term Oxygen Therapy.

    Science.gov (United States)

    Walterspacher, Stephan; July, Johanna; Kohlhäufl, Martin; Rzehak, Peter; Windisch, Wolfram

    2016-09-01

    Respiratory insufficiency in COPD may present as hypoxic and/or hypercapnic respiratory failure treated with long-term oxygen therapy (LTOT) and/or noninvasive ventilation (NIV) with LTOT. The Severe Respiratory Insufficiency Questionnaire (SRI) is a tool for the assessment of health-related quality of life (HRQOL) in subjects receiving NIV. However, it remains unclear whether the SRI is also capable of assessing and discriminating HRQOL in subjects receiving LTOT. Stable subjects with COPD receiving LTOT or NIV + LTOT (NIV) were prospectively recruited and completed the SRI, lung function tests, and blood gases. Confirmatory factor analysis for construct validity and internal consistency reliability were calculated. One hundred fifty-five subjects were included (113 LTOT, 42 NIV). The Cronbach α coefficient of the 7 subscales ranged between 0.69 and 0.89 (LTOT) and between 0.79 and 0.93 (NIV), respectively. In both groups, confirmatory factor analysis revealed a one-factor model for the SRI summary scale; in 5 subscales, one- or 2-factor models could be established. Group differences in the SRI subsets were all P <.05 (except for physical functioning) with higher scores in subjects receiving NIV. The SRI showed high reliability and validity in subjects with COPD receiving LTOT. Subjects receiving LTOT had lower SRI scores, indicating a poorer HRQOL compared with subjects with established NIV and LTOT. Copyright © 2016 by Daedalus Enterprises.

  17. Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial.

    Science.gov (United States)

    Yeung, Wing-Fai; Chung, Ka-Fai; Zhang, Zhang-Jin; Chan, Wai-Chi; Zhang, Shi-Ping; Ng, Roger Man-Kin; Chan, Connie Lai-Wah; Ho, Lai-Ming; Yu, Yee-Man; Lao, Li-Xing

    2017-03-31

    Conventional approaches for benzodiazepine tapering have their limitations. Anecdotal studies have shown that acupuncture is a potential treatment for facilitating successful benzodiazepine tapering. As of today, there was no randomized controlled trial examining its efficacy and safety. The purpose of the study is to evaluate the efficacy of using electroacupuncture as an adjunct treatment to gradual tapering of benzodiazepine doses in complete benzodiazepine cessation in long-term benzodiazepine users. The study protocol of a randomized, assessor- and subject-blinded, controlled trial is presented. One hundred and forty-four patients with histories of using benzodiazepines in ≥50% of days for more than 3 months will be randomly assigned in a 1:1 ratio to receive either electroacupuncture or placebo electroacupuncture combined with gradual benzodiazepine tapering schedule. Both experimental and placebo treatments will be delivered twice per week for 4 weeks. Major assessments will be conducted at baseline, week 6 and week 16 post-randomization. Primary outcome is the cessation rate of benzodiazepine use. Secondary outcomes include the percentage change in the doses of benzodiazepine usage and the severity of withdrawal symptoms experienced based on the Benzodiazepine Withdrawal Symptom Questionnaire, insomnia as measured by the Insomnia Severity Index, and anxiety and depressive symptoms as evaluated by the Hospital Anxiety and Depression Scale. Adverse events will also be measured at each study visit. Results of this study will provide high quality evidence of the efficacy and safety of electroacupuncture as an adjunct treatment for benzodiazepine tapering in long-term users. ClinicalTrials.gov NCT02475538 .

  18. Subjective memory ability and long-term forgetting in patients referred for neuropsychological assessment

    Directory of Open Access Journals (Sweden)

    Sieberen Pieter Van Der Werf

    2016-05-01

    Full Text Available It has been suggested that the memory complaints of patients who are not impaired on formal memory tests may reflect accelerated forgetting. We examined this hypothesis by comparing the one-week delayed recall and recognition test performance of outpatients who were referred for neuropsychological assessment and who had normal memory performance during standard memory assessment with that of a non-patient control group. Both groups performed equally in verbal learning and delayed recall. However, after one week, the patients performed worse than controls on both recall and recognition tests. Although subjective memory ability predicted short-term memory function in patients, it did not predict long-term delayed forgetting rates in either the patients or controls. Thus, long-term delayed recall and recognition intervals provided no additional value to explain poor subjective memory ability in the absence of objective memory deficits.

  19. 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.

  20. Short- versus long-term prediction of dementia among subjects with low and high educational levels.

    Science.gov (United States)

    Chary, Emilie; Amieva, Hélène; Pérès, Karine; Orgogozo, Jean-Marc; Dartigues, Jean-François; Jacqmin-Gadda, Hélène

    2013-09-01

    Using simple measures of cognition and disability in a prospective community-living cohort of normal elderly persons, the main objectives of our study were to distinguish short- and long-term predictors for dementia according to educational level and to propose a tool for early detection of subjects at high risk of dementia. Data derived from the French cohort study Paquid (Personnes Agées QUID), which included 3777 subjects, older than 65 years of age, who were followed for a 20-year period. The risk of dementia at 3 years and 10 years was estimated by logistic regression for repeated measures combining data from all the 3- and 10-year windows throughout the follow-up. Predictors included disability assessed by the number of dependent items among four instrumental activities of daily living (IADLs), four neuropsychological tests, five Mini-Mental State Examination (MMSE) subtests, and four items of subjective memory complaints. Of the 2882 included subjects, the number of IADLs remained a predictor of short- and long-term conversion to dementia for those with low educational level (combined with only one cognitive test) whereas the best predictors for more educated subjects combined subjective memory complaints and memory and executive function tests. The episodic memory subtest was the only predictive MMSE subtest. In the high-education-level group, the areas under the receiver-operating characteristic curve of the selected models were 0.85 for 3-year prediction and 0.78 for 10-year prediction. Early predictors of dementia are different according to educational level. Among subjects reaching the secondary school level, early detection of those at high risk of dementia is possible with good predictive performance, with a few simple objective and subjective cognitive evaluations. Copyright © 2013 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

  1. SHORT TERM EFFECT OF ACUPUNCTURE-TENS ON LUNG FUNCTIONS AND DYSPNEA FOR SUBJECTS WITH MODERATE COPD

    Directory of Open Access Journals (Sweden)

    Vinod Babu. K

    2015-10-01

    Full Text Available Background: Acupuncture TENS is used to improve pain instead of invasive acupuncture. Acupuncture shown to improve dyspnoea and lung functions in COPD (Chronic Obstructive Pulmonary Disease patients. The purpose of the study is to determine Short term effectiveness of Acupuncture-TENS in reducing dyspnea and improving lung functions for subjects with moderate COPD. Method: An experimental study design, selected 30 geriatric subjects with COPD randomized 15 subjects into each Study and Control group. Study group received Acu-TENS for 45 minutes for total 5 sessions, while control group received placebo TENS. Outcome measurements such as breathlessness using Modified Borg Scale (MBS, Lung functions using Pulmonary Function Test (PFT was measured before and after intervention. Results: Analysis from pre-intervention to post-intervention within study group found that there is statistically significant change in means of MBS, FEV1, FEV1/FVC ratio and within control group there is a statistically significant change in means of MBS, but there is no statistically significant change in means of FEV1, FVC and FEV1/FVC ratio. When post-intervention means were compared between the groups there is no statistically significant difference in means of MBS and FEV1, FVC and FEV1/FVC ratio. Conclusion: It is concluded that one week of Acu-TENS on EXL1 point found no significant effect on improving dyspnea and lung functions in subjects with moderate COPD in geriatric populations.

  2. Subjective Sleep Quality and hormonal modulation in long-term yoga practitioners.

    Science.gov (United States)

    Vera, Francisca M; Manzaneque, Juan M; Maldonado, Enrique F; Carranque, Gabriel A; Rodriguez, Francisco M; Blanca, Maria J; Morell, Miguel

    2009-07-01

    Yoga represents a fascinating mind-body approach, wherein body movements (asana), breathing exercises (pranayama) and meditation are integrated into a single multidimensional practice. Numerous beneficial mental and physical effects have been classically ascribed to this holistic ancient method. The purpose of the present study has been to examine the effects of long-term yoga practice on Subjective Sleep Quality (SSQ) and on several hormonal parameters of the hypothalamus-pituitary-adrenal (HPA) axis. Twenty-six subjects (16 experimental and 10 controls) were recruited to be part of the study. Experimental subjects were regular yoga practitioners with a minimum of 3 years of practice. Blood samples for the quantification of adrenocorticotropic hormone (ACTH), cortisol and dehydroepiandrosterone sulphate (DHEA-S) were drawn from all subjects. Likewise, the Pittsburgh Sleep Quality Index (PSQI) was employed to assess SSQ. As statistical analysis, Mann-Whitney U-test was performed. The yoga group displayed lower PSQI scores and higher blood cortisol levels than control subjects. Therefore, it can be concluded that long-term yoga practice is associated with significant psycho-biological differences, including better sleep quality as well as a modulatory action on the levels of cortisol. These preliminary results suggest interesting clinical implications which should be further researched.

  3. Long-term endurance training increases serum cathepsin S levels in healthy female subjects.

    Science.gov (United States)

    Sponder, M; Minichsdorfer, C; Campean, I-A; Emich, M; Fritzer-Szekeres, M; Litschauer, B; Strametz-Juranek, J

    2017-11-27

    Circulating cathepsin S (CS) has been associated with a lower risk for breast cancer in a large Swedish cohort. Long-term physical activity has been shown to have beneficial effects on the development of various cancer subtypes, in particular breast and colorectal cancers. The aim of this study was to investigate the effect of long-term endurance sport on CS levels in females. Thirty-six of 40 subjects completed the study. Subjects were told to increase their activity pensum for 8 months reaching 150 min/week moderate or 75 min/week intense exercise. Ergometries were performed at the beginning and the end of the study to prove/quantify the performance gain. Blood samples were drawn at baseline and every 2 months. Serum CS levels were measured by ELISA. To analyse the change and the progression of CS, Wilcoxon rank sum and Friedman tests were used. The sportive group (performance gain by > 4.9%) showed a significant increase of CS levels from 3.32/2.73/4.09 to 4.00/3.09/5.04 ng/ml (p = 0.008) corresponding to an increase of 20.5%. We could show a significant increase of circulating CS levels in healthy female subjects induced by long-term physical activity. CS, occurring in the tumour microenvironment, is well-known to promote tumour growth, e.g. by ameliorating angiogenesis. However, the role of circulating CS in cancer growth is not clear. As physical activity is known as preventive intervention, in particular concerning breast and colorectal cancers, and long-term physical activity leads to an increase of CS levels in female subjects, circulating CS might even be involved in this protective effect. Clinical trial registration: NCT02097199.

  4. The study of subjective feelings of loneliness older women in terms of suicide risk

    Directory of Open Access Journals (Sweden)

    Kudryashov E.L.

    2014-12-01

    Full Text Available The results of the study of subjective feeling lonely older women and their actual social status in terms of the propensity to suicidal behavior. Hypothesized that the level of suicide risk in older women reveals a closer connection with the severity of subjective feelings of loneliness than with the degree of objective social isolation. The study involved 52 women aged 55 to 75 years old who do not have mental disorders and debilitating physical illness. The main methods of study was the analysis of medical records, interview and psychological testing formalized. Data used for U-Mann-Whitney test, H-Kruskal-Wallis test, and Pearson criterion 2 Spearman rank correlation method. It is shown that the severity of suicidal risk in the studied sample is really linked to the level of subjective feelings of loneliness (p≤0,05, in respect of the same objective social isolation test found no such relationship.

  5. Metacognition of visual short-term memory: Dissociation between objective and subjective components of VSTM

    Directory of Open Access Journals (Sweden)

    Silvia eBona

    2013-02-01

    Full Text Available The relationship between the objective accuracy of visual-short term memory (VSTM representations and their subjective conscious experience is unknown. We investigated this issue by assessing how the objective and subjective components of VSTM in a delayed cue-target orientation discrimination task are affected by intervening distracters. On each trial, participants were shown a memory cue (a grating, the orientation of which they were asked to hold in memory. On approximately half of the trials, a distractor grating appeared during the maintenance interval; its orientation was either identical to that of the memory cue, or it differed by 10 or 40 degrees. The distractors were masked and presented briefly, so they were only consciously perceived on a subset of trials. At the end of the delay period, a memory test probe was presented, and participants were asked to indicate whether it was tilted to the left or right relative to the memory cue (VSTM accuracy; objective performance. In order to assess subjective metacognition, participants were asked indicate the vividness of their memory for the original memory cue. Finally, participants were asked rate their awareness of the distracter. Results showed that objective VSTM performance was impaired by distractors only when the distractors were very different from the cue, and that this occurred with both subjectively visible and invisible distractors. Subjective metacognition, however, was impaired by distractors of all orientations, but only when these distractors were subjectively invisible. Our results thus indicate that the objective and subjective components of VSTM are to some extent dissociable.

  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. 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).

  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. Moderate alcohol consumption predicts long-term mortality in elderly subjects with chronic heart failure.

    Science.gov (United States)

    Gargiulo, G; Testa, G; Cacciatore, F; Mazzella, F; Galizia, G; Della-Morte, D; Langellotto, A; Pirozzi, G; Ferro, G; Ferrara, N; Rengo, F; Abete, P

    2013-01-01

    Moderate alcohol consumption is related to a reduction of mortality. However, this phenomenon is not well established in the elderly, especially in the presence of chronic heart failure (CHF). The aim of the study was to verify the effect of moderate alcohol consumption on 12-year mortality in elderly community-dwelling with and without CHF. community-dwelling from 5 regions of Italy. A cohort of 1332 subjects aged 65 and older. Mortality after 12-year follow-up in elderly subjects (≥65 years old) with and without CHF was studied. Moderate alcohol consumption was considered ≤250 ml/day (drinkers). In the absence of CHF (n=947), mortality was 42.2% in drinkers vs. 53.7% in non-drinker elderly subjects (p=0.021). In contrast, in the presence of CHF (n=117), mortality was 86.5% in drinkers vs. 69.7% in non-drinker elderly subjects (p=0.004). Accordingly, Cox regression analysis shows that a moderate alcohol consumption is protective of mortality in the absence (HR=0.79; CI 95% 0.66-0.95; pmoderate alcohol consumption is associated with an increased long-term mortality risk in the elderly in the presence of CHF.

  11. Predictors of long-term benzodiazepine abstinence in participants of a randomized controlled benzodiazepine withdrawal program.

    NARCIS (Netherlands)

    Oude Voshaar, R.C.; Gorgels, W.J.M.J.; Mol, A.J.J.; Balkom, A.J.L.M. van; Mulder, J.; Lisdonk, E.H. van de; Breteler, M.H.M.; Zitman, F.G.

    2006-01-01

    OBJECTIVE: To identify predictors of resumed benzodiazepine use after participation in a benzodiazepine discontinuation trial. METHOD: We performed multiple Cox regression analyses to predict the long-term outcome of a 3-condition, randomized, controlled benzodiazepine discontinuation trial in

  12. Short-Term Effect of Gabapentin on Subjective Tinnitus in Acoustic Trauma Patients

    Directory of Open Access Journals (Sweden)

    Ali Goljanian Tabrizi

    2017-03-01

    Full Text Available Introduction:Although several treatment approaches have been proposed for tinnitus, there are currently no Food and Drug Administration (FDA-approved agents available to treat this condition. In this study, we evaluated the effect of gabapentin on the sensation of subjective tinnitus in patients with acoustic trauma referring to the ear, nose and throat (ENT clinic of Taleghani Hospital during 2014. Materials and Methods:In this double-blind, randomized clinical trial, 103 patients with tinnitus due to acoustic trauma who were referred to the ENT clinic of Taleghani Hospital during 2014 were randomized to the gabapentin (300 mg bid, n=55 or control (n=48 groups. The two groups were then compared before and after 6 weeks of treatment using a visual analog scale (VAS. At least a 30% reduction in VAS was considered a response to treatment. Results:Differences between the two groups regarding sex, age, duration of disease, and audiometry results was not significant (P>0.05. After 6 weeks’ treatment, the VAS significantly decreased in both groups (P

  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. Long-term clearance from small airways in subjects with ciliary dysfunction

    Directory of Open Access Journals (Sweden)

    Hjelte Lena

    2006-05-01

    Full Text Available Abstract The objective of this study was to investigate if long-term clearance from small airways is dependent on normal ciliary function. Six young adults with primary ciliary dyskinesia (PCD inhaled 111 Indium labelled Teflon particles of 4.2 μm geometric and 6.2 μm aerodynamic diameter with an extremely slow inhalation flow, 0.05 L/s. The inhalation method deposits particles mainly in the small conducting airways. Lung retention was measured immediately after inhalation and at four occasions up to 21 days after inhalation. Results were compared with data from ten healthy controls. For additional comparison three of the PCD subjects also inhaled the test particles with normal inhalation flow, 0.5 L/s, providing a more central deposition. The lung retention at 24 h in % of lung deposition (Ret24 was higher (p 24 with slow inhalation flow was 73.9 ± 1.9 % compared to 68.9 ± 7.5 % with normal inhalation flow in the three PCD subjects exposed twice. During day 7–21 the three PCD subjects exposed twice cleared 9 % with normal flow, probably representing predominantly alveolar clearance, compared to 19 % with slow inhalation flow, probably representing mainly small airway clearance. This study shows that despite ciliary dysfunction, clearance continues in the small airways beyond 24 h. There are apparently additional clearance mechanisms present in the small airways.

  15. 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

  16. 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.

  17. 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

  18. 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

  19. Long-term wheat germ intake beneficially affects plasma lipids and lipoproteins in hypercholesterolemic human subjects.

    Science.gov (United States)

    Cara, L; Armand, M; Borel, P; Senft, M; Portugal, H; Pauli, A M; Lafont, H; Lairon, D

    1992-02-01

    In previous short-term studies in rats and humans, the ingestion of raw wheat germ lowered plasma triglycerides and cholesterol. Thus, the present study was designed to investigate the possible long-term effects of wheat germ intake. Diet supplementation with raw wheat germ or partially defatted wheat germ was tested in two separate groups of 10 and 9 free-living human subjects, respectively. They all exhibited hypercholesterolemia (6.14-9.67 mmol/L cholesterol) and 11 had hypertriglyceridemia. None was diabetic. Fasting blood samples were taken at the beginning of the study, after 4 wk of 20 g/d wheat germ intake, after 14 additional weeks of 30 g/d wheat germ intake and after 12 wk without any supplementation. Dietary records were kept for seven and three consecutive days, before and during the wheat germ intake periods, respectively. Raw wheat germ intake significantly decreased plasma cholesterol (-8.7%) and tended to reduce VLDL cholesterol (-19.6%) after 4 wk. After 14 additional weeks, plasma cholesterol (-7.2%) and LDL cholesterol (-15.4%) remained lower and plasma triglycerides (-11.3%) tended to be lower. The apo B:apo A1 ratio significantly decreased after both periods. Partially defatted wheat germ transiently decreased plasma triglycerides and cholesterol after a 4-wk intake. The present data indicate that wheat germ reduces cholesterolemia in the long term and could play a beneficial role in the dietary management of type IIa and IIb hyperlipidemia.

  20. Misoprostol versus oxytocin for labor induction in term and post-term pregnancy: randomized controlled trial

    OpenAIRE

    Aquino, Márcia Maria Auxiliadora de; Cecatti, José Guilherme

    2003-01-01

    CONTEXT: Misoprostol, a synthetic E1 methyl analog prostaglandin, is at present receiving attention as a cervical modifier and labor induction agent. However, there is still a need for better determination of its safety and effectiveness. OBJECTIVE: To compare intravaginal misoprostol versus intravenous oxytocin for cervical ripening and labor induction in pregnant women with unripe cervices. DESIGN: Randomized controlled trial. SETTING: The study was performed at the Leonor Mendes de Barros ...

  1. 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...

  2. Nonparametric Monitoring for Geotechnical Structures Subject to Long-Term Environmental Change

    Directory of Open Access Journals (Sweden)

    Hae-Bum Yun

    2011-01-01

    Full Text Available A nonparametric, data-driven methodology of monitoring for geotechnical structures subject to long-term environmental change is discussed. Avoiding physical assumptions or excessive simplification of the monitored structures, the nonparametric monitoring methodology presented in this paper provides reliable performance-related information particularly when the collection of sensor data is limited. For the validation of the nonparametric methodology, a field case study was performed using a full-scale retaining wall, which had been monitored for three years using three tilt gauges. Using the very limited sensor data, it is demonstrated that important performance-related information, such as drainage performance and sensor damage, could be disentangled from significant daily, seasonal and multiyear environmental variations. Extensive literature review on recent developments of parametric and nonparametric data processing techniques for geotechnical applications is also presented.

  3. Relevance of a subjective quality of life questionnaire for long-term homeless persons with schizophrenia.

    Science.gov (United States)

    Girard, V; Tinland, A; Bonin, J P; Olive, F; Poule, J; Lancon, C; Apostolidis, T; Rowe, M; Greacen, T; Simeoni, M C

    2017-02-17

    Increasing numbers of programs are addressing the specific needs of homeless people with schizophrenia in terms of access to housing, healthcare, basic human rights and other domains. Although quality of life scales are being used to evaluate such programs, few instruments have been validated for people with schizophrenia and none for people with schizophrenia who experience major social problems such as homelessness. The aim of the present study was to validate the French version of the S-QoL a self-administered, subjective quality of life questionnaire specific to schizophrenia for people with schizophrenia who are homeless. In a two-step process, the S-QoL was first administered to two independent convenience samples of long-term homeless people with schizophrenia in Marseille, France. The objective of the first step was to analyse the psychometric properties of the S-QoL. The objective of the second step was to examine, through qualitative interviews with members of the population in question, the relevance and acceptability of the principle quality of life indicators used in the S-QoL instrument. Although the psychometric characteristics of the S-QoL were found to be globally satisfactory, from the point of view of the people being interviewed, acceptability was poor. Respondents frequently interrupted participation complaining that questionnaire items did not take into account the specific context of life on the streets. Less intrusive questions, more readily understandable vocabulary and greater relevance to subjects' living conditions are needed to improve the S-QoL questionnaire for this population. A modular questionnaire with context specific sections or specific quality of life instruments for socially excluded populations may well be the way forward.

  4. Short-term triglyceride lowering with fenofibrate improves vasodilator function in subjects with hypertriglyceridemia.

    Science.gov (United States)

    Capell, Warren H; DeSouza, Christopher A; Poirier, Paul; Bell, Melanie L; Stauffer, Brian L; Weil, Kathleen M; Hernandez, Teri L; Eckel, Robert H

    2003-02-01

    The objective of this study was to investigate the effects of lowering plasma triglycerides (TGs) on endothelial function and gain insight into the role played by free fatty acids (FFAs) in hypertriglyceridemia-associated vascular dysfunction. Eleven hypertriglyceridemic subjects without coronary artery disease, diabetes, elevated low-density lipoprotein cholesterol, tobacco use, or hypertension were studied using a randomized, double-blinded, crossover design (fenofibrate and placebo, 14 days). After each regimen, forearm blood flow was assessed by plethysmography in response to arterial acetylcholine, nitroprusside, and verapamil infusion. Hourly plasma TGs, FFA, glucose, and insulin were measured during a 24-hour feeding cycle to characterize the metabolic environment. Changes in plasma FFA after intravenous heparin were used to estimate typical FFA accumulation in the luminal endothelial microenvironment. Fenofibrate lowered plasma TG (P<0.001), total cholesterol (P<0.01), and apolipoprotein B (P<0.01) without altering high-density lipoprotein or low-density lipoprotein cholesterol concentrations. Forearm blood flow in response to acetylcholine (P<0.0001), nitroprusside (P<0.001), and verapamil (P<0.0001) improved after fenofibrate. Fenofibrate lowered 24-hour (P<0.0001) and post-heparin (P<0.001) TG and tended to lower 24-hour (P=0.054) and post-heparin (P=0.028) FFA. Vascular smooth muscle function significantly improves after lowering plasma TG without changes in confounding lipoproteins or insulin resistance. The data raise additional questions regarding the role of FFA in hypertriglyceridemia-associated vascular dysfunction.

  5. 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…

  6. Misoprostol versus oxytocin for labor induction in term and post-term pregnancy: randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Márcia Maria Auxiliadora de Aquino

    Full Text Available CONTEXT: Misoprostol, a synthetic E1 methyl analog prostaglandin, is at present receiving attention as a cervical modifier and labor induction agent. However, there is still a need for better determination of its safety and effectiveness. OBJECTIVE: To compare intravaginal misoprostol versus intravenous oxytocin for cervical ripening and labor induction in pregnant women with unripe cervices. DESIGN: Randomized controlled trial. SETTING: The study was performed at the Leonor Mendes de Barros Maternity Hospital between November 1998 and December 2000. PARTICIPANTS: 210 pregnant women with intact membranes and indication for labor induction were selected. PROCEDURES: The women randomly received 25 µg of vaginal misoprostol every 4 hours, not exceeding 8 doses (105 women, or oxytocin in a continuous infusion (105 women. MAIN MEASUREMENTS: The main parameters measured were: latent period, time from induction to vaginal delivery, delivery route, occurrence of vaginal delivery with time, occurrence of uterine tonus alterations, hypoxia and neonatal morbidity. To verify the statistical significance of the differences between the groups, the chi-squared, Student t and log-rank tests were used. RESULTS: There were no significant differences between the groups concerning conditions for labor induction, age, parity, race, marital status, family income, initial Bishop Index and number of prenatal visits. The cesarean section rate, latent period and period from induction to vaginal delivery were significantly lower for the misoprostol group. With regard to uterine tonus alterations, tachysystole was significantly more common in the misoprostol group. However, there was no difference in hypoxia and neonatal morbidity between the groups. CONCLUSION: 25 µg of misoprostol used vaginally every 4 hours is safer and more efficient for cervical ripening and labor induction than oxytocin.

  7. Short Term Effects of Neurodynamic Stretching and Static Stretching Techniques on Hamstring Muscle Flexibility in Healthy Male Subjects

    OpenAIRE

    Adel Rashad Ahmed; Ahmed Fathy Samhan

    2016-01-01

    Flexibility is a key component of rehabilitation and inadequate muscle extensibility remains a commonly accepted factor for musculoskeletal disorders. Studies on the most optimal technique for improving muscle flexibility are a widely debated. The aim of the study was to compare the effectiveness of neurodynamic and static stretching techniques on hamstring flexibility in healthy male subjects. This study was a randomized experimental trial; forty healthy male subjects with hamstr...

  8. 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

  9. The effects of a nucleotide supplement on the immune and metabolic response to short term, high intensity exercise performance in trained male subjects.

    Science.gov (United States)

    Mc Naughton, L; Bentley, D; Koeppel, P

    2007-03-01

    The aim of this work was to determine the ergogenic effects of a nucleotide supplement on the metabolic and immune responses to short term high intensity exercise in volunteer, trained, male subjects. Thirty moderately trained male subjects were randomly divided into 3 equal sized groups, control (C), placebo (P) or experimental (E). Each subject undertook a 2 min maximal exercise test prior to, and after 60 days, on either a nucleotide (E) or placebo supplement. Prior to exercise testing unstimulated saliva samples and blood samples were taken. Saliva was analysed for cortisol and IgA, while blood was analysed for lactate, lactate dehydrogenase and creatine kinase. The postexercise C value was significantly higher than the pre-exercise concentration (Pchanges in blood lactate, lactate dehydrogenase, or creatine kinase concentrations post supplementation. We concluded that a chronically ingested nucleotide supplement blunts the response of the hormones associated with physiological stress.

  10. 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.

  11. Controlled Terms or Free Terms? A JavaScript Library to Utilize Subject Headings and Thesauri on the Web

    Directory of Open Access Journals (Sweden)

    Shun Nagaya

    2011-10-01

    Full Text Available There are two types of keywords used as metadata: controlled terms and free terms. Free terms have the advantage that metadata creators can freely select keywords, but there also exists a disadvantage that the information retrieval recall ratio might be reduced. The recall ratio can be improved by using controlled terms. But creating and maintaining controlled vocabularies has an enormous cost. In addition, many existing controlled vocabularies are published in formats less suitable for programming. We introduce a JavaScript library called “covo.js” that enables us to make use of controlled vocabularies as metadata for the organization of web pages.

  12. 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.

  13. 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

  14. 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.

  15. Negative emotion enhances mnemonic precision and subjective feelings of remembering in visual long-term memory.

    Science.gov (United States)

    Xie, Weizhen; Zhang, Weiwei

    2017-09-01

    Negative emotion sometimes enhances memory (higher accuracy and/or vividness, e.g., flashbulb memories). The present study investigates whether it is the qualitative (precision) or quantitative (the probability of successful retrieval) aspect of memory that drives these effects. In a visual long-term memory task, observers memorized colors (Experiment 1a) or orientations (Experiment 1b) of sequentially presented everyday objects under negative, neutral, or positive emotions induced with International Affective Picture System images. In a subsequent test phase, observers reconstructed objects' colors or orientations using the method of adjustment. We found that mnemonic precision was enhanced under the negative condition relative to the neutral and positive conditions. In contrast, the probability of successful retrieval was comparable across the emotion conditions. Furthermore, the boost in memory precision was associated with elevated subjective feelings of remembering (vividness and confidence) and metacognitive sensitivity in Experiment 2. Altogether, these findings suggest a novel precision-based account for emotional memories. Copyright © 2017 Elsevier B.V. All rights reserved.

  16. Short and long-term effects of sham-controlled prefrontal EEG-neurofeedback training in healthy subjects

    NARCIS (Netherlands)

    Engelbregt, H.J.; Keeser, D.; van Eijk, L.; Suiker, E.M.; Eichhorn, D.; Karch, S.; Deijen, J.B.; Pogarell, O.

    2016-01-01

    Objective: In this study we evaluated long-term effects of frontal beta EEG-neurofeedback training (E-NFT) on healthy subjects. We hypothesized that E-NFT can change frontal beta activity in the long-term and that changes in frontal beta EEG activity are accompanied by altered cognitive performance.

  17. Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur.

    Science.gov (United States)

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Etén-Bergqvist, Christina; Persson, Jan

    2011-07-01

    The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety. We set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up. No significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.

  18. 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

  19. 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

  20. The effect of duration of exercise at the ventilation threshold on subjective appetite and short-term food intake in 9 to 14 year old boys and girls

    Directory of Open Access Journals (Sweden)

    Pencharz Paul B

    2009-10-01

    Full Text Available Abstract Background The effect of exercise on subjective appetite and short-term food intake has received little investigation in children. Despite a lack of reported evaluation of short-duration activity programs, they are currently being implemented in schools as a means to benefit energy balance. The purpose of this study was to determine the effect of duration of exercise at the ventilation threshold (VeT on subjective appetite and short-term food intake in normal weight boys and girls aged 9 to 14 years. Methods On 4 separate mornings and in random order, boys (n = 14 and girls (n = 15 completed 2 rest or 2 exercise treatments for 15 (short-duration; SD or 45 min (long-duration; LD at their previously measured VeT, 2 h after a standardized breakfast. Subjective appetite was measured at regular intervals during the study sessions and food intake from a pizza meal was measured 30 min after rest or exercise. Results An increase in average appetite, desire to eat, and hunger (p Conclusion Neither SD nor LD exercise at the VeT increased short-term food intake and SD exercise attenuated increases in appetite. Thus, SD exercise programs in schools may be an effective strategy for maintaining healthier body weights in children.

  1. β-Glucan and dark chocolate: a randomized crossover study on short-term satiety and energy intake.

    Science.gov (United States)

    Akyol, Asli; Dasgin, Halil; Ayaz, Aylin; Buyuktuncer, Zehra; Besler, H Tanju

    2014-09-23

    The aims of this study were to adapt a traditional recipe into a healthier form by adding 3 g of oat β-glucan, substituting milk chocolate to dark chocolate with 70% cocoa, and to examine the effect of these alterations on short-term satiety and energy intake. Study subjects (n = 25) were tested in a randomized, crossover design with four products closely matched for energy content. Four different versions of a traditional recipe including milk chocolate-control (CON), oat β-glucan (B-GLU), dark chocolate (DARK) or oat β-glucan and dark chocolate (B-GLU + DARK) were given to subjects on different test days. After subjects were asked to report visual analog scale (VAS) scores on sensory outcomes and related satiety for four hours ad libitum, lunch was served and energy intake of individuals was measured. VAS scores indicated that none of the test foods exerted an improved effect on satiety feelings. However, energy intake of individuals during ad libitum lunch was significantly lower in dark chocolate groups (CON: 849.46 ± 47.45 kcal versus DARK: 677.69 ± 48.45 kcal and B-GLU + DARK: 691.08 ± 47.45 kcal, p = 0.014). The study demonstrated that substituting dark chocolate for milk chocolate is more effective in inducing satiety during subsequent food intake in healthy subjects.

  2. β-Glucan and Dark Chocolate: A Randomized Crossover Study on Short-Term Satiety and Energy Intake

    Directory of Open Access Journals (Sweden)

    Asli Akyol

    2014-09-01

    Full Text Available Aim: The aims of this study were to adapt a traditional recipe into a healthier form by adding 3 g of oat β-glucan, substituting milk chocolate to dark chocolate with 70% cocoa, and to examine the effect of these alterations on short-term satiety and energy intake. Materials and Methods: Study subjects (n = 25 were tested in a randomized, crossover design with four products closely matched for energy content. Four different versions of a traditional recipe including milk chocolate-control (CON, oat β-glucan (B-GLU, dark chocolate (DARK or oat β-glucan and dark chocolate (B-GLU + DARK were given to subjects on different test days. After subjects were asked to report visual analog scale (VAS scores on sensory outcomes and related satiety for four hours ad libitum, lunch was served and energy intake of individuals was measured. Results: VAS scores indicated that none of the test foods exerted an improved effect on satiety feelings. However, energy intake of individuals during ad libitum lunch was significantly lower in dark chocolate groups (CON: 849.46 ± 47.45 kcal versus DARK: 677.69 ± 48.45 kcal and B-GLU + DARK: 691.08 ± 47.45 kcal, p = 0.014. Conclusion: The study demonstrated that substituting dark chocolate for milk chocolate is more effective in inducing satiety during subsequent food intake in healthy subjects.

  3. Reduction of randomness in seismic noise as a short-term precursor to a volcanic eruption.

    Science.gov (United States)

    Glynn, C C; Konstantinou, K I

    2016-11-24

    Ambient seismic noise is characterized by randomness incurred by the random position and strength of the noise sources as well as the heterogeneous properties of the medium through which it propagates. Here we use ambient noise data recorded prior to the 1996 Gjálp eruption in Iceland in order to show that a reduction of noise randomness can be a clear short-term precursor to volcanic activity. The eruption was preceded on 29 September 1996 by a Mw ~5.6 earthquake that occurred in the caldera rim of the Bárdarbunga volcano. A significant reduction of randomness started occurring 8 days before the earthquake and 10 days before the onset of the eruption. This reduction was observed even at stations more than 100 km away from the eruption site. Randomness increased to its previous levels 160 minutes after the Bárdarbunga earthquake, during which time aftershocks migrated from the Bárdarbunga caldera to a site near the Gjálp eruption fissure. We attribute this precursory reduction of randomness to the lack of higher frequencies (>1 Hz) in the noise wavefield caused by high absorption losses as hot magma ascended in the upper crust.

  4. 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.

  5. 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

  6. Short-Term Effects of Electroconvulsive Therapy on Subjective and Actigraphy-Assessed Sleep Parameters in Severely Depressed Inpatients

    Directory of Open Access Journals (Sweden)

    Alexander Hoogerhoud

    2015-01-01

    Full Text Available Background. Sleep disturbances are a key feature of major depression. Electroconvulsive treatment (ECT may improve polysomnography-assessed sleep characteristics, but its short-term effects on actigraphy-assessed and subjective sleep characteristics are unknown. We therefore aimed to assess the effects of ECT on subjective and objective sleep parameters in a proof-of-principle study. Methods. We assessed subjective and objective sleep parameters in 12 severely depressed patients up to 5 consecutive days during their ECT course, corresponding to a total of 43 nights (including 19 ECT sessions. The 12 patients were 83% female and on average 62 (standard deviation (SD 14 years old and had an average MADRS score of 40 at baseline (SD 21. Results. Subjective and objective sleep parameters were not directly affected by ECT. The subjective sleep efficiency parameter was similar on the day after ECT and other days. ECT did not affect the number of errors in the Sustained Attention to Response Task. Patients subjectively underestimated their total sleep time by 1.4 hours (P<0.001 compared to actigraphy-assessed sleep duration. Conclusion. ECT did not affect subjective and actigraphy-assessed sleep in the short term. Depressed patients profoundly underestimated their sleep duration.

  7. Acute, subacute and long-term subjective effects of psilocybin in healthy humans: a pooled analysis of experimental studies.

    Science.gov (United States)

    Studerus, Erich; Kometer, Michael; Hasler, Felix; Vollenweider, Franz X

    2011-11-01

    Psilocybin and related hallucinogenic compounds are increasingly used in human research. However, due to limited information about potential subjective side effects, the controlled medical use of these compounds has remained controversial. We therefore analysed acute, short- and long-term subjective effects of psilocybin in healthy humans by pooling raw data from eight double-blind placebo-controlled experimental studies conducted between 1999 and 2008. The analysis included 110 healthy subjects who had received 1-4 oral doses of psilocybin (45-315 µg/kg body weight). Although psilocybin dose-dependently induced profound changes in mood, perception, thought and self-experience, most subjects described the experience as pleasurable, enriching and non-threatening. Acute adverse drug reactions, characterized by strong dysphoria and/or anxiety/panic, occurred only in the two highest dose conditions in a relatively small proportion of subjects. All acute adverse drug reactions were successfully managed by providing interpersonal support and did not need psychopharmacological intervention. Follow-up questionnaires indicated no subsequent drug abuse, persisting perception disorders, prolonged psychosis or other long-term impairment of functioning in any of our subjects. The results suggest that the administration of moderate doses of psilocybin to healthy, high-functioning and well-prepared subjects in the context of a carefully monitored research environment is associated with an acceptable level of risk.

  8. 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

  9. 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.

  10. An adaptive random search for short term generation scheduling with network constraints.

    Directory of Open Access Journals (Sweden)

    J A Marmolejo

    Full Text Available This paper presents an adaptive random search approach to address a short term generation scheduling with network constraints, which determines the startup and shutdown schedules of thermal units over a given planning horizon. In this model, we consider the transmission network through capacity limits and line losses. The mathematical model is stated in the form of a Mixed Integer Non Linear Problem with binary variables. The proposed heuristic is a population-based method that generates a set of new potential solutions via a random search strategy. The random search is based on the Markov Chain Monte Carlo method. The main key of the proposed method is that the noise level of the random search is adaptively controlled in order to exploring and exploiting the entire search space. In order to improve the solutions, we consider coupling a local search into random search process. Several test systems are presented to evaluate the performance of the proposed heuristic. We use a commercial optimizer to compare the quality of the solutions provided by the proposed method. The solution of the proposed algorithm showed a significant reduction in computational effort with respect to the full-scale outer approximation commercial solver. Numerical results show the potential and robustness of our approach.

  11. Necessary conditions for the invariant measure of a random walk to be a sum of geometric terms

    NARCIS (Netherlands)

    Chen, Y.; Boucherie, Richardus J.; Goseling, Jasper

    We consider the invariant measure of homogeneous random walks in the quarter-plane. In particular, we consider measures that can be expressed as an infinite sum of geometric terms. We present necessary conditions for the invariant measure of a random walk to be a sum of geometric terms. We

  12. Subject-Verb Agreement and Verbal Short-Term Memory: A Perspective from Greek Children with Specific Language Impairment

    Science.gov (United States)

    Lalioti, Marina; Stavrakaki, Stavroula; Manouilidou, Christina; Talli, Ioanna

    2016-01-01

    This study investigated the performance of school age Greek-speaking children with SLI on verbal short-term memory (VSTM) and Subject-Verb (S-V) agreement in comparison to chronological age controls and younger typically developing children. VSTM abilities were assessed by means of a non-word repetition task (NRT) and an elicited production task,…

  13. 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.

  14. 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.

  15. 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

  16. The long-term effects of chronic recreational ketamine use on cognition and subjective experiences

    OpenAIRE

    Grayer, J. P.

    2007-01-01

    Rationale: A review of the chronic recreational ketamine research is needed because of (i) increases in recreational ketamine use in the past five years, and (ii) its application to the N-Methyl-D-Aspartate-Receptor ('NMDA-R') hypofunction model of psychosis.;Method: PsychInfo and Pubmed databases were searched using the following terms: 'ketamine', 'frequent', 'regular*, 'repeated', 'chronic', and 'long-term'. The search was limited to human populations and English language journals. Relevan...

  17. 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.

  18. 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

  19. 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.

  20. 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...

  1. Global synchronization of memristive neural networks subject to random disturbances via distributed pinning control.

    Science.gov (United States)

    Guo, Zhenyuan; Yang, Shaofu; Wang, Jun

    2016-12-01

    This paper presents theoretical results on global exponential synchronization of multiple memristive neural networks in the presence of external noise by means of two types of distributed pinning control. The multiple memristive neural networks are coupled in a general structure via a nonlinear function, which consists of a linear diffusive term and a discontinuous sign term. A pinning impulsive control law is introduced in the coupled system to synchronize all neural networks. Sufficient conditions are derived for ascertaining global exponential synchronization in mean square. In addition, a pinning adaptive control law is developed to achieve global exponential synchronization in mean square. Both pinning control laws utilize only partial state information received from the neighborhood of the controlled neural network. Simulation results are presented to substantiate the theoretical results. Copyright © 2016 Elsevier Ltd. All rights reserved.

  2. 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.

  3. Global Judgments of Subjective Well-Being: Situational Variability and Long-Term Stability

    Science.gov (United States)

    Eid, Michael; Diener, Ed

    2004-01-01

    Subjective well-being (SWB) is an important indicator of quality of life. SWB can be conceptualized as a momentary state (e.g., mood) as well as a relatively stable trait (e.g., life satisfaction). The validity of self-reported trait aspects of SWB has been questioned by experimental studies showing that SWB judgments seem to be strongly context…

  4. Dyslipidemia in HIV-1 Infected Subjects with Short Term Usage of ...

    African Journals Online (AJOL)

    Michaelis

    ultimately leads to gluconeogenesis, hyperinsulinaemia, insulin resistance, increased fat synthesis as well as, fatty liver development and weight gain are biochemical abnormalities that can directly alter liver enzymes and lipid profiles in HAART using. HIV subjects. Occurrence of mitochondrial dysfunction is listed as part of ...

  5. Changes in total energy intake and macronutrient composition after bariatric surgery predict long-term weight outcome: findings from the Swedish Obese Subjects (SOS) study.

    Science.gov (United States)

    Kanerva, Noora; Larsson, Ingrid; Peltonen, Markku; Lindroos, Anna-Karin; Carlsson, Lena M

    2017-07-01

    Background: Approximately 20-30% of obese patients do not achieve successful weight outcomes after bariatric surgery.Objective: We examined whether short-term changes (≤0.5 y postsurgery) in energy intake and macronutrient composition after bariatric surgery could predict 10-y weight change.Design: Participants were recruited from the Swedish Obese Subjects (SOS) study, which was a matched (nonrandomized) prospective trial that compared bariatric surgery with usual care for obese patients. A total of 2010 patients who underwent bariatric surgery were included in the study. Physical examinations (e.g., weight) and questionnaires (e.g., dietary questionnaire) were completed before and 0.5, 1, 2, 3, 4, 6, 8, and 10 y after surgery. For the main analytic strategy, a linear mixed model was implemented, which included repeated measures with a random intercept and an unstructured covariance matrix.Results: Short-term changes in energy intake (P bariatric surgery. At the 10-y follow-up, men and women with the largest reductions in energy intake had lost 7.3% and 3.9% more weight, respectively, compared with that of subjects with the smallest intake reductions (P bariatric surgery predicts long-term weight loss. Weight loss is also associated with a changing dietary macronutrient composition. This trial was registered at clinicaltrials.gov as NCT01479452. © 2017 American Society for Nutrition.

  6. 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.

  7. The difference in subjective and objective complexity in the visual short-term memory

    DEFF Research Database (Denmark)

    Dall, Jonas Olsen; Sørensen, Thomas Alrik

    Several studies discuss the influence of complexity on the visual short term memory; some have demonstrated that short-term memory is surprisingly stable regardless of content (e.g. Luck & Vogel, 1997) where others have shown that memory can be influenced by the complexity of stimulus (e.g. Alvarez...... of expertise (e.g. Dall, et al., 2016). We will present a paradigm testing the proposed distinction using specific isolation of attentional components (see Bundesen, 1990; Sørensen, Vangkilde, & Bundesen, 2015). We propose that objective complexity can be manipulated through the number of strokes in Chinese...

  8. 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

  9. 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.

  10. 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.

  11. Long-term effects of a Palaeolithic-type diet in obese postmenopausal women: a two-year randomized trial

    Science.gov (United States)

    Mellberg, Caroline; Sandberg, Susanne; Ryberg, Mats; Eriksson, Marie; Brage, Sören; Larsson, Christel; Olsson, Tommy; Lindahl, Bernt

    2014-01-01

    Background/Objectives Short-term studies have suggested beneficial effects of a Palaeolithic-type diet (PD) on body weight and metabolic balance. We now report long-term effects in obese postmenopausal women of a PD on anthropometric measurements and metabolic balance, in comparison with a diet according to the Nordic Nutrition Recommendations (NNR). Subjects/Methods Seventy obese postmenopausal women (mean age 60 years, body mass index 33 kg/m2) were assigned to an ad libitum PD or NNR diet in a 2-year randomized controlled trial. The primary outcome was change in fat mass as measured by dual energy X-ray absorptiometry. Results Both groups significantly decreased total fat mass at 6 months (−6.5 and −2.6 kg) and 24 months (−4.6 and −2.9 kg), with a more pronounced fat loss in the PD group at 6 months (Pdiet regarding fat mass, abdominal obesity and triglyceride levels in obese postmenopausal women; effects not fully sustained for anthropometric measurements at 24 months. Adherence to protein intake was poor in the PD group. The long-term consequences of these changes remain to be studied. PMID:24473459

  12. Important prognostic factors for the long-term survival of lung cancer subjects in Taiwan

    Directory of Open Access Journals (Sweden)

    Ko Albert

    2008-11-01

    Full Text Available Abstract Background This study used a large-scale cancer database in determination of prognostic factors for the survival of lung cancer subjects in Taiwan. Methods Total of 24,910 subjects diagnosed with lung cancer was analysed. Survival estimates by Kaplan-Meier methods. Cox proportional-hazards model estimated the death risk (hazard ratio (HR for various prognostic factors. Results The prognostic indicators associated with a higher risk of lung cancer deaths are male gender (males versus females; HR = 1.07, 95% confidence intervals (CI: 1.03–1.11, males diagnosed in later periods (shown in 1991–1994 versus 1987–1990; HR = 1.13, older age at diagnosis, large cell carcinoma (LCC/small cell carcinoma (SCC, and supportive care therapy over chemotherapy. The overall 5-year survival rate for lung cancer death was significantly poorer for males (21.3% than females (23.6%. Subjects with squamous cell carcinoma (SQCC and treatment by surgical resection alone had better prognosis. We find surgical resections to markedly increase 5-year survival rate from LCC, decreased risk of death from LCC, and no improved survival from SCC. Conclusion Gender and clinical characteristics (i.e. diagnostic period, diagnostic age, histological type and treatment modality play important roles in determining lung cancer survival.

  13. Short Term Effects of Neurodynamic Stretching and Static Stretching Techniques on Hamstring Muscle Flexibility in Healthy Male Subjects

    Directory of Open Access Journals (Sweden)

    Adel Rashad Ahmed

    2016-05-01

    Full Text Available Flexibility is a key component of rehabilitation and inadequate muscle extensibility remains a commonly accepted factor for musculoskeletal disorders. Studies on the most optimal technique for improving muscle flexibility are a widely debated. The aim of the study was to compare the effectiveness of neurodynamic and static stretching techniques on hamstring flexibility in healthy male subjects. This study was a randomized experimental trial; forty healthy male subjects with hamstring tightness were randomly divided into two equal groups: The neurodynamic group and the static stretching group. Treatment was given for 5 consecutive days and the outcomes were measured using Active knee Extension Test and Straight Leg Raising. There was a significant improvement in hamstring flexibility following application of both neurodynamic and static stretching but the improvement in the neurodynamic group (p<0.001 was better than that of the static group (p<0.02. Results suggest that a neurodynamic stretching could increase hamstring flexibility to a greater extent than static stretching in healthy male subjects with a tight hamstring.

  14. The salivary microbiome is consistent between subjects and resistant to impacts of short-term hospitalization.

    Science.gov (United States)

    Cabral, Damien J; Wurster, Jenna I; Flokas, Myrto E; Alevizakos, Michail; Zabat, Michelle; Korry, Benjamin J; Rowan, Aislinn D; Sano, William H; Andreatos, Nikolaos; Ducharme, R Bobby; Chan, Philip A; Mylonakis, Eleftherios; Fuchs, Beth Burgwyn; Belenky, Peter

    2017-09-08

    In recent years, a growing amount of research has begun to focus on the oral microbiome due to its links with health and systemic disease. The oral microbiome has numerous advantages that make it particularly useful for clinical studies, including non-invasive collection, temporal stability, and lower complexity relative to other niches, such as the gut. Despite recent discoveries made in this area, it is unknown how the oral microbiome responds to short-term hospitalization. Previous studies have demonstrated that the gut microbiome is extremely sensitive to short-term hospitalization and that these changes are associated with significant morbidity and mortality. Here, we present a comprehensive pipeline for reliable bedside collection, sequencing, and analysis of the human salivary microbiome. We also develop a novel oral-specific mock community for pipeline validation. Using our methodology, we analyzed the salivary microbiomes of patients before and during hospitalization or azithromycin treatment to profile impacts on this community. Our findings indicate that azithromycin alters the diversity and taxonomic composition of the salivary microbiome; however, we also found that short-term hospitalization does not impact the richness or structure of this community, suggesting that the oral cavity may be less susceptible to dysbiosis during short-term hospitalization.

  15. A short-term high fat diet increases exposure to midazolam and omeprazole in healthy subjects

    NARCIS (Netherlands)

    Achterbergh, Roos; Lammers, Laureen A.; van Nierop, Samuel; Klümpen, Heinz-Josef; Soeters, Maarten R.; Mathôt, Ron A. A.; Romijn, Johannes A.

    2016-01-01

    Knowledge of factors contributing to variation in drug metabolism is of vital importance to optimize drug treatment. This study assesses the effects of a short-term hypercaloric high fat diet on metabolism of five oral drugs, which are each specific for a single P450 isoform: midazolam (CYP3A4),

  16. Recent onmiddellijk geheugenonderzoek bij zwakzinnigen [Investigation of short term memory in mentally retarded subjects

    NARCIS (Netherlands)

    Bunt, A.A.

    1975-01-01

    The aim of this literature review is to get a preliminary answer to the problem of the type of information processing deficit of undifferentiated retardates (with an IQ of about 70). Taking the topic of verbal short-term memory as a framework, it appears that children or adults of a subnormal

  17. 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.

  18. Long-term effectiveness of unboosted atazanavir plus abacavir/lamivudine in subjects with virological suppression

    DEFF Research Database (Denmark)

    Llibre, Josep M; Cozzi-Lepri, Alessandro; Pedersen, Court

    2016-01-01

    VL), performing a time to loss of virological response (TLOVR Virological failure (VF) was defined as confirmed pVL >50 copies/mL.We included 285 subjects, 67% male, with median baseline CD4 530 cells, and 44 months with pVL ≤50 copies/mL. The third...... drug in the previous regimen was ritonavir-boosted atazanavir (ATV/r) in 79 (28%), and another ritonavir-boosted protease inhibitor (PI/r) in 29 (10%). Ninety (32%) had previously failed with a PI. Proportions of people with virological success at 48/96/144 weeks were 90%/87%/88% (TLOVR) and 74...

  19. 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.

  20. Interaction between mode of learning and subjective experience: translation effects in long-term memory.

    Science.gov (United States)

    Rackie, James M; Brandt, Karen R; Eysenck, Michael W

    2015-01-01

    It has been suggested that writing auditorily presented words at encoding involves distinctive translation processes between visual and auditory domains, leading to the formation of distinctive memory traces at retrieval. This translation effect leads to higher levels of recognition than the writing of visually presented words, a non-translation effect. The present research investigated whether writing and the other translation effect of vocalisation (vocalising visually presented words) would be present in tests of recall, recognition memory and whether these effects are based on the subjective experience of remembering or knowing. Experiment 1 found a translation effect in the auditory domain in recall, as the translation effect of writing yielded higher recall than both non-translation effects of vocalisation and silently hearing. Experiment 2 found a translation effect in the visual domain in recognition, as the translation effect of vocalisation yielded higher recognition than both non-translation effects of writing and silently reading. This translation effect was attributable to the subjective experience of remembering rather than knowing. The present research therefore demonstrates the beneficial effect of translation in both recall and recognition, with the effect of vocalisation in recognition being based on rich episodic remembering.

  1. Effects of pregabalin on subjective sleep disturbance symptoms during withdrawal from long-term benzodiazepine use.

    Science.gov (United States)

    Rubio, Gabriel; Bobes, Julio; Cervera, Gaspar; Terán, Antonio; Pérez, María; López-Gómez, Vanessa; Rejas, Javier

    2011-01-01

    To evaluate the effectiveness of pregabalin as a tapering therapy on the subjective sleep quality of patients who underwent a benzodiazepine withdrawal program in routine medical practice. Secondary analysis of a 12-week prospective, open noncontrolled study carried out in patients who met DSM-IV-TR criteria for benzodiazepine dependence. Sleep was evaluated with the Medical Outcomes Study Sleep Scale (MOS Sleep Scale). 282 patients were included in the analysis. Mean (±SD) pregabalin dose was 315 ± 166 mg/day at the end of the trial. We observed a significant and clinically relevant improvement in sleep outcomes at the endpoint, with a total score reduction from 55.8 ± 18.9 to 25.1 ± 18.0 at week 12 (i.e. a 55% reduction). Similar findings were apparent using the six dimensions of the MOS Sleep Scale. Moderate correlations were observed between the MOS Sleep summary index and sleep domains, and there were improvements in anxiety symptoms and disease severity. These findings suggest that pregabalin may improve subjective sleep quality in patients who underwent a benzodiazepine withdrawal program. This effect appears to be partly independent of improvements in symptoms of anxiety or withdrawal. However, controlled studies are needed to establish the magnitude of the effect of pregabalin. Copyright © 2011 S. Karger AG, Basel.

  2. Combination therapy containing ritonavir plus saquinavir has superior short-term antiretroviral efficacy: a randomized trial

    DEFF Research Database (Denmark)

    Kirk, O; Katzenstein, T L; Gerstoft, J

    1999-01-01

    OBJECTIVES: To compare the efficacy and safety of indinavir 800 mg three times a day, ritonavir 600 mg twice a day, and a combination of ritonavir 400 mg twice a day and saquinavir 400 mg twice a day, when administered with two nucleoside analogues. DESIGN: A randomized, open-labelled, controlled...... is generally safe, and has superior short-term antiviral efficacy compared with indinavir and ritonavir also combined with two nucleoside analogues in antiretroviral drug-naive patients. Further follow-up is needed to determine the durability of the viral response....

  3. 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

  4. 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.

  5. Redox proteomics and physiological responses in Cistus albidus shrubs subjected to long-term summer drought followed by recovery

    OpenAIRE

    Brossa, Ricard; Pint?-Marijuan, Marta; Francisco, Rita; L?pez-Carbonell, Marta; Chaves, Maria Manuela; Alegre, Leonor

    2014-01-01

    Main conclusion The interaction between enzymatic and non-enzymatic antioxidants, endogenous levels of ABA and ABA-GE, the rapid recuperation of photosynthetic proteins under re-watering as well the high level of antioxidant proteins in previously drought-stressed plants under re-watering conditions, will contribute to drought resistance in plants subjected to a long-term drought stress under Mediterranean field conditions. This work provides an overview of the mechanisms of Cistus albidus ac...

  6. Gut microbiome response to short-term dietary interventions in reactive hypoglycemia subjects.

    Science.gov (United States)

    Quercia, Sara; Turroni, Silvia; Fiori, Jessica; Soverini, Matteo; Rampelli, Simone; Biagi, Elena; Castagnetti, Andrea; Consolandi, Clarissa; Severgnini, Marco; Pianesi, Mario; Fallucca, Francesco; Pozzilli, Paolo; Brigidi, Patrizia; Candela, Marco

    2017-11-01

    Reactive hypoglycemia is a metabolic disorder that provokes severe hypoglycemic episodes after meals. Over recent years, the gut microbiota has been recognized as potential target for the control of metabolic diseases, and the possibility to correct gut microbiota dysbioses through diet, favouring the recovery of metabolic homeostasis, has been considered. We investigate the impact of 2 short-term (3-day) nutritional interventions, based on the macrobiotic Ma-Pi 2 diet and a control Mediterranean diet, on the structure and functionality of the gut microbiota in 12 patients affected by reactive hypoglycemia. The gut microbiota composition was characterized by next-generation sequencing of the V3 to V4 region of the 16S rRNA gene, and the ecosystem functionality was addressed by measuring the faecal concentration of short-chain fatty acids (SCFAs). In order to measure the short-term physiological gut microbiota fluctuation, the microbiomes of 7 healthy people were characterized before and after 3 days of constant diet. While no convergence of the gut microbiota compositional profiles was observed, a significant increase in SCFA faecal levels was induced only in the Ma-Pi 2 diet group, suggesting the potential of this diet to support a short-term functional convergence of the gut microbiota, regardless of the individual compositional layout. The Ma-Pi 2 diet, with its high fibre load, was effective in increasing the production of SCFAs by the gut microbiota. Because these metabolites are known for their ability to counterbalance the metabolic deregulation in persons with glucose impairment disorders, their increased bioavailability could be of some relevance in reactive hypoglycemia. Copyright © 2017 John Wiley & Sons, Ltd.

  7. Long-term Denitrification Processes and Kinetics in a Crystalline Aquifer subject to Pumping from 1991

    Science.gov (United States)

    Roques, Clement; Aquilina, Luc; Vergnaud-Ayraud, Virginie; Boisson, Alexandre; Labasque, Thierry; Longuevergne, Laurent; Ben Maamar, Sarah; Dufresne, Alexis; Bour, Olivier

    2017-04-01

    The kinetic of denitrification associated to long-term mixing processes in heterogeneous aquifers is particularly challenging to constrain. Specifically, chemical evolutions related to groundwater exploitation are cases that are poorly known. It remains particularly unclear if long-term pumping whether enhances or slows-down the nitrate reducing processes and what is the source of electron donor sustaining the reaction. The aim of this study is to investigate the dynamic of denitrification processes induced by long-term pumping in the Ploemeur aquifer (Britany, France) which has been operated for water supply since 1991. Several batch experiments have been carried out in order to fully characterize the kinetics of the denitrification reaction involved. Batches consisted in crushed rock: more or less weathered granite and schists, and water sampled from the site. Denitrification always developed except in sterilized batchs. Denitrification rate was independent on the rock type but more on the state of the bacterial community. Inorganic dissolved carbon only showed moderate variations while organic carbon remained at low concentrations. Both observations make heterotrophic denitrification unlikely. A silicate dissolution was observed and detailed analysis of the cations quantified a main biotite contribution. The iron produced by biotite dissolution accounts for the denitrification processes observed. Long term time-series analysis of the conservative elements recorded at the pumped well were used to determine mixing fractions from different compartments of the aquifer based on a Principal Component Analysis approach coupled with an end-member mixing analysis. Discharge fractions were then used to quantify the denitrification kinetic linked to pumping. With increasing concentration of Nitrate entering in the groundwater system since the beginning of the operations, computations confirm that i) autotrophic denitrification processes are dominant and ii) biotite plays a

  8. 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.

  9. A short-term high fat diet increases exposure to midazolam and omeprazole in healthy subjects.

    Science.gov (United States)

    Achterbergh, Roos; Lammers, Laureen A; van Nierop, Samuel; Klümpen, Heinz-Josef; Soeters, Maarten R; Mathôt, Ron A A; Romijn, Johannes A

    2016-07-01

    Knowledge of factors contributing to variation in drug metabolism is of vital importance to optimize drug treatment. This study assesses the effects of a short-term hypercaloric high fat diet on metabolism of five oral drugs, which are each specific for a single P450 isoform: midazolam (CYP3A4), omeprazole (CYP2C19), metoprolol (CYP2D6), S-warfarin (CYP2C9) and caffeine (CYP1A2). In 9 healthy volunteers, pharmacokinetics of the five drugs were assessed after an overnight fast at two separate occasions: after a regular diet and after 3 days of a hypercaloric high fat diet (i.e. regular diet supplemented with 500 mL cream [1715 kcal, 35% fat]). Pharmacokinetic parameters (mean [SEM]) were estimated by non-compartmental analysis. The high fat diet increased exposure to midazolam by 19% from 24.7 (2.6) to 29.5 (3.6) ng ml-1h-1 (p=0.04) and exposure to omeprazole by 31% from 726 (104) to 951 (168) ng ml-1h-1 (p=0.05). Exposure to metoprolol, caffeine and S-warfarin was not affected by the high fat diet. A short-term hypercaloric high fat diet increases exposure to midazolam and omeprazole, possibly reflecting modulation of CYP3A4 and CYP2C19.

  10. Objective and subjective sleep quality: Melatonin versus placebo add-on treatment in patients with schizophrenia or bipolar disorder withdrawing from long-term benzodiazepine use.

    Science.gov (United States)

    Baandrup, Lone; Glenthøj, Birte Yding; Jennum, Poul Jørgen

    2016-06-30

    Benzodiazepines are frequently long-term prescribed for the treatment of patients with severe mental illness. This prescribing practice is problematic because of well-described side effects including risk of dependence. We examined the efficacy of prolonged-release melatonin on objective and subjective sleep quality during benzodiazepine discontinuation and whether sleep variables were associated with benzodiazepine withdrawal. Eligible patients included adults with a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder and long-term use of benzodiazepines in combination with antipsychotics. All participants gradually tapered the use of benzodiazepines after randomization to add-on treatment with melatonin versus placebo. Here we report a subsample of 23 patients undergoing sleep recordings (one-night polysomnography) and 55 patients participating in subjective sleep quality ratings. Melatonin had no effect on objective sleep efficiency, but significantly improved self-reported sleep quality. Reduced benzodiazepine dosage at the 24-week follow-up was associated with a significantly decreased proportion of stage 2 sleep. These results indicate that prolonged-release melatonin has some efficacy for self-reported sleep quality after gradual benzodiazepine dose reduction, and that benzodiazepine discontinuation is not associated with rebound insomnia in medicated patients with severe mental illness. However, these findings were limited by a small sample size and a low retention rate. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  11. 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

  12. Effect of Talbinah food consumption on depressive symptoms among elderly individuals in long term care facilities, randomized clinical trial.

    Science.gov (United States)

    Badrasawi, Manal M; Shahar, Suzana; Abd Manaf, Zahara; Haron, Hasnah

    2013-01-01

    Talbinah is a barley syrup cooked with milk and sweetened by honey. In his famous Hadith on Talbinah, the Prophet Mohammad (SAW) recommended it when sad events happen for its effect on soothing hearts and relieving sadness. This 3-week crossover designed, randomized clinical trial was conducted to determine the effect of Talbinah on mood and depression among institutionalized elderly people in Seremban. A sample of 30 depressed elderly subjects (21 men and 9 women) was selected from the long term care facility. Three different interview-based validated scales (Geriatric Depression Scale, Depression Anxiety Stress Scales, and Profile of Mood States) were used to determine mood, depression, stress, and anxiety at week 0, 3, 4, and 7. The nutritional value of Talbinah was examined using proximate food analysis, minerals content analysis, and differential amino acid analysis. The results indicated that Talbinah is a high carbohydrate food (86.4%) and has a high tryptophan: branch chain amino acids ratio (1:2). A Wilcoxon nonparametric test showed that there was a statistically significant decrease on depression, stress, and mood disturbances scores among the intervention group (P < 0.05) for all parameters. In conclusion, Talbinah has the potential to reduce depression and enhance mood among the subjects. Ingestion of functional foods such as Talbinah may provide a mental health benefit to elderly people.

  13. Retropubic tension-free vaginal tape and inside-out transobturator tape: a long-term randomized trial.

    Science.gov (United States)

    Zhang, Zhibo; Zhu, Lan; Xu, Tao; Lang, Jinghe

    2016-01-01

    The tension-free vaginal tape (TVT) and inside-out transobturator tape (TVT-O) are first-line surgical treatments for stress urinary incontinence (SUI). However, there is a lack of information regarding the long-term comparative safety of these procedures. A total of 140 SUI patients were randomized to the TVT or TVT-O procedure and were interviewed by an independent investigator at the follow-up. The primary outcomes were the proportions of patients with long-term postoperative complications. The secondary outcomes included the cure rates, quality of life (QOL) and sexual function based on validated questionnaires. One hundred and twenty (85.71%) patients completed the long-term follow-up. More TVT patients experienced perioperative complications (P < 0.05). However, in a mean follow-up of 95 months, no significant between-group difference was found in the proportions of patients with long-term complications or in the variety of reported complications. The long-term complication rates for TVT and TVT-O were 43.1% and 27.4% respectively (P = 0.07). De novo voiding (15.8%) and storage symptoms (10.8%) were the primary long-term complications. Tape exposure was possible up to 7 years after TVT-O. The objective cure rates of TVT and TVT-O procedures were 79.30 and 69.35% respectively, which were not significantly higher than the subjective rates. The Pelvic Floor Impact Questionnaire (PFIQ-7) scores remained improved (P < 0.001) after both procedures, even at the 95-month follow-up. No difference was observed in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Short Form (PISQ-12) scores after either procedure. In the long term, the proportion of patients with complications and the cure rates of the two procedures did not differ significantly. The long-term complication rates were high, but morbidity was low, and the QOL remained improved.

  14. Improved Neural Networks with Random Weights for Short-Term Load Forecasting

    Science.gov (United States)

    Lang, Kun; Zhang, Mingyuan; Yuan, Yongbo

    2015-01-01

    An effective forecasting model for short-term load plays a significant role in promoting the management efficiency of an electric power system. This paper proposes a new forecasting model based on the improved neural networks with random weights (INNRW). The key is to introduce a weighting technique to the inputs of the model and use a novel neural network to forecast the daily maximum load. Eight factors are selected as the inputs. A mutual information weighting algorithm is then used to allocate different weights to the inputs. The neural networks with random weights and kernels (KNNRW) is applied to approximate the nonlinear function between the selected inputs and the daily maximum load due to the fast learning speed and good generalization performance. In the application of the daily load in Dalian, the result of the proposed INNRW is compared with several previously developed forecasting models. The simulation experiment shows that the proposed model performs the best overall in short-term load forecasting. PMID:26629825

  15. Crash Frequency Analysis Using Hurdle Models with Random Effects Considering Short-Term Panel Data.

    Science.gov (United States)

    Chen, Feng; Ma, Xiaoxiang; Chen, Suren; Yang, Lin

    2016-10-26

    Random effect panel data hurdle models are established to research the daily crash frequency on a mountainous section of highway I-70 in Colorado. Road Weather Information System (RWIS) real-time traffic and weather and road surface conditions are merged into the models incorporating road characteristics. The random effect hurdle negative binomial (REHNB) model is developed to study the daily crash frequency along with three other competing models. The proposed model considers the serial correlation of observations, the unbalanced panel-data structure, and dominating zeroes. Based on several statistical tests, the REHNB model is identified as the most appropriate one among four candidate models for a typical mountainous highway. The results show that: (1) the presence of over-dispersion in the short-term crash frequency data is due to both excess zeros and unobserved heterogeneity in the crash data; and (2) the REHNB model is suitable for this type of data. Moreover, time-varying variables including weather conditions, road surface conditions and traffic conditions are found to play importation roles in crash frequency. Besides the methodological advancements, the proposed technology bears great potential for engineering applications to develop short-term crash frequency models by utilizing detailed data from field monitoring data such as RWIS, which is becoming more accessible around the world.

  16. Long-term results of a randomized clinical trial comparing Roux-en-Y gastric bypass with vertical banded gastroplasty.

    Science.gov (United States)

    Werling, M; Fändriks, L; Björklund, P; Maleckas, A; Brandberg, J; Lönroth, H; le Roux, C W; Olbers, T

    2013-01-01

    The long-term results of Roux-en-$\\hbox{Y}$ gastric bypass (gastric bypass) and vertical banded gastroplasty (VBG) from randomized studies have not been described in detail. Patients were randomized to gastric bypass or VBG. Body mass index (BMI), body composition, eating habits and gastrointestinal hormones were reviewed after 6 years. The frequency of reoperation was assessed up to 10 years after surgery. Sixty-six (80 per cent) of the 82 subjects randomized were assessed for weight and BMI 6 years after surgery, 30 (81 per cent) in the gastric bypass group and 36 (80 per cent) in the VBG group. Intention-to-treat analysis demonstrated greater weight loss after gastric bypass compared with VBG, 6 years after surgery: BMI reduced from 41·8 (95 per cent confidence interval 41·3 to 42·3) to 30·3 (28·6 to 32·0) kg/m(2) for gastric bypass and from 42·3 (42·8 to 44·8) to 32·9 (31·3 to 34·5) kg/m(2) for VBG (P = 0·036). Gastric bypass caused a larger loss of fat mass (P = 0·026) and better preservation of lean tissue (P = 0·009). Patients having a gastric bypass had greater postprandial responses to the satiety hormones glucagon-like peptide 1 and peptide YY (P = 0·003 and P = 0·004 respectively). Ghrelin levels did not differ between the groups. Patients with a gastric bypass maintained a lower intake of fat compared with those having VBG (P = 0·013). Some 89 per cent of patients who initially had VBG had undergone, or were scheduled for, conversion to gastric bypass at latest follow-up. Gastric bypass was superior to VBG regarding weight loss, body composition, dietary composition and postprandial satiety hormone responses. Copyright © 2012 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

  17. Change in hydraulic traits of Mediterranean Quercus ilex subjected to long-term throughfall exclusion.

    Science.gov (United States)

    Limousin, Jean-Marc; Longepierre, Damien; Huc, Roland; Rambal, Serge

    2010-08-01

    Mediterranean tree species experience unpredictable climate environments and severe summer droughts and they may be impaired by the trend of decline in precipitation projected as a consequence of global climate change. The response of Quercus ilex to drought was studied by measuring hydraulic traits of trees growing in a mature forest subjected to partial throughfall exclusion for 6 years. We measured hydraulic conductivity, xylem vulnerability to embolism, and anatomical features in branches and roots. Xylem vulnerability to embolism was higher in the dry treatment than in the control treatment, P₅₀ of branches was on average -3.88 +/- 0.80 MPa for the control treatment compared with -3.41 +/- 0.80 MPa for the dry treatment, but the difference was not statistically significant. A similar difference between treatments was observed for roots, which exhibited lower P₅₀ values. This change of xylem vulnerability to embolism was not linked to modification of the hydraulic conductivity or vessel anatomy, which remained unaffected by the throughfall exclusion treatment. The xylem density of branches was lower in the dry treatment. The hydraulic conductivity was correlated with the mean vessel diameter of xylem, but the P₅₀ was not. The main response of trees from the dry treatment to reduced water availability appeared to be a reduction in the transpiring leaf area, which resulted in significantly increased leaf-specific conductivity.

  18. Invariant measures and error bounds for random walks in the quarter-plane based on sums of geometric terms

    NARCIS (Netherlands)

    Chen, Y.; Boucherie, Richardus J.; Goseling, Jasper

    2016-01-01

    We consider homogeneous random walks in the quarter-plane. The necessary conditions which characterize random walks of which the invariant measure is a sum of geometric terms are provided in Chen et al. (arXiv:1304.3316, 2013, Probab Eng Informational Sci 29(02):233–251, 2015). Based on these

  19. 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.

  20. 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.

  1. 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.

  2. Randomized Trial of Longer-Term Therapy for Symptoms Attributed to Lyme Disease.

    Science.gov (United States)

    Berende, Anneleen; ter Hofstede, Hadewych J M; Vos, Fidel J; van Middendorp, Henriët; Vogelaar, Michiel L; Tromp, Mirjam; van den Hoogen, Frank H; Donders, A Rogier T; Evers, Andrea W M; Kullberg, Bart Jan

    2016-03-31

    The treatment of persistent symptoms attributed to Lyme disease remains controversial. We assessed whether longer-term antibiotic treatment of persistent symptoms attributed to Lyme disease leads to better outcomes than does shorter-term treatment. In a randomized, double-blind, placebo-controlled trial conducted in Europe, we assigned patients with persistent symptoms attributed to Lyme disease--either related temporally to proven Lyme disease or accompanied by a positive IgG or IgM immunoblot assay for Borrelia burgdorferi--to receive a 12-week oral course of doxycycline, clarithromycin plus hydroxychloroquine, or placebo. All study groups received open-label intravenous ceftriaxone for 2 weeks before initiating the randomized regimen. The primary outcome measure was health-related quality of life, as assessed by the physical-component summary score of the RAND-36 Health Status Inventory (RAND SF-36) (range, 15 to 61, with higher scores indicating better quality of life), at the end of the treatment period at week 14, after the 2-week course of ceftriaxone and the 12-week course of the randomized study drug or placebo had been completed. Of the 281 patients who underwent randomization, 280 were included in the modified intention-to-treat analysis (86 patients in the doxycycline group, 96 in the clarithromycin-hydroxychloroquine group, and 98 in the placebo group). The SF-36 physical-component summary score did not differ significantly among the three study groups at the end of the treatment period, with mean scores of 35.0 (95% confidence interval [CI], 33.5 to 36.5) in the doxycycline group, 35.6 (95% CI, 34.2 to 37.1) in the clarithromycin-hydroxychloroquine group, and 34.8 (95% CI, 33.4 to 36.2) in the placebo group (P=0.69; a difference of 0.2 [95% CI, -2.4 to 2.8] in the doxycycline group vs. the placebo group and a difference of 0.9 [95% CI, -1.6 to 3.3] in the clarithromycin-hydroxychloroquine group vs. the placebo group); the score also did not differ

  3. Comparison of Subjective Sleep Quality of Long-Term Residents at Low and High Altitudes: SARAHA Study.

    Science.gov (United States)

    Gupta, Ravi; Ulfberg, Jan; Allen, Richard P; Goel, Deepak

    2018-01-15

    To study the effect of altitude on subjective sleep quality in populations living at high and low altitudes after excluding cases of restless legs syndrome (RLS). This population-based study was conducted at three different altitudes (400 m, 1,900-2,000 m, and 3,200 m above sea level). All consenting subjects available from random stratified sampling in the Himalayan and sub-Himalayan regions of India were included in the study (ages 18 to 84 years). Sleep quality and RLS status were assessed using validated translations of Pittsburgh Sleep Quality Index (PSQI) and Cambridge Hopkins RLS diagnostic questionnaire. Recent medical records were screened to gather data for medical morbidities. In the total sample of 1,689 participants included, 55.2% were women and average age of included subjects was 35.2 (± 10.9) years. In this sample, overall 18.4% reported poor quality of sleep (PSQI ≥ 5). Poor quality of sleep was reported more commonly at high altitude compared to low altitude (odds ratio [OR] = 2.65; 95% CI = 1.9-3.7; P quality of sleep were male sex, smoking, chronic obstructive pulmonary disease (COPD), and varicose veins. Binary logistic regression indicated that COPD (OR = 1.97; 95% CI = 1.36-2.86; P quality of sleep. This study showed that poor quality of sleep was approximately twice as prevalent at high altitudes compared to low altitudes even after removing the potential confounders such as RLS and COPD.

  4. Prospective and randomized clinical trial comparing transobturator versus retropubic sling in terms of efficacy and safety.

    Science.gov (United States)

    Palos, Claudia Cristina; Maturana, Ana P; Ghersel, Frederico R; Fernandes, Cesar E; Oliveira, Emerson

    2018-01-01

    The midurethral sling is the most commonly performed surgical procedure for stress urinary incontinence (SUI). We compared the efficacy of transobturator tape (TOT) and retropubic (RP) slings by evaluating objective and subjective cure rates at 12 months postsurgery and evaluate the impact on quality of life (QoL) and record intra- and postoperative complications. This was a randomized, controlled, prospective, clinical trial with analysis of noninferiority. The hypothesis was that the TOT sling is not inferior to the RP sling. A total of 92 women with SUI were selected and randomized into two groups: TOT and RP slings. Eighty-one patients maintained follow-up 12 months postoperatively. In the per-protocol analysis, the objective cure rates were 100% for the RP sling and 93% for the TOT sling (p = 0.029). The subjective cure rates were 92% for the RP sling and 90% for the TOT sling (p = 0.02). Because none of the upper limits of the confidence interval (CI) were above the noninferiority margin, noninferiority of the TOT sling could be concluded. In contrast, the intention-to-treat analysis could not show that the TOT sling was not inferior to the RP sling, because the upper limit of the CI surpassed the noninferiority margin. Postoperative complications were similar for both groups, except for higher urinary retention rates in the RP group. Regarding QoL, there was a significant improvement. The cure rates of the per-protocol analysis showed the noninferiority of the TOT relative to the RP sling. The RP sling group exhibited higher urinary retention. Quality of life improved significantly in both groups.

  5. Subjective socioeconomic status as a predictor of long-term care staff burnout and positive caregiving experiences.

    Science.gov (United States)

    Ayalon, Liat

    2008-06-01

    The potentially negative consequences associated with providing care to older adults are well documented. Recently, there has been an increasing interest in the positive aspects associated with caregiving. Both aspects are believed to represent a continuum of caregiving experiences. Long-term care (LTC) staff members often report high levels of burnout associated with their work. Whereas several job characteristics and objective indicators of socioeconomic status have been identified as potential predictors of LTC staff caregiving experiences, the role of subjective socioeconomic status (i.e. one's view of one's place in society) has not yet been evaluated. A cross-sectional design of 122 LTC staff members. LTC staff completed the Maslach Burnout Inventory and the Positive Aspects of Caregiving questionnaire. They also completed questions about job characteristics (i.e. staff-to-resident ratio, number of hours worked per day, and years of experience working with older adults), objective sociodemographic variables (i.e. level of education, professional affiliation), and subjective socioeconomic indicator (i.e. MacArthur Scale of Subjective Social Status). Hierarchical regression analyses were conducted to identify the unique contribution of job characteristics, objective socioeconomic status, and subjective socioeconomic status to LTC staff caregiving experiences. Subjective socioeconomic status remained a significant predictor of LTC staff experience even once job characteristics and objective indicators of socioeconomic status were entered into the model. Those who placed themselves higher on the subjective social ladder reported higher levels of positive caregiving experiences and lower levels of burnout. Building a sense of community identity and improving one's status within the community might result in lower levels of burnout and better caregiving experiences among LTC staff.

  6. Long-term effect of bariatric surgery on liver enzymes in the Swedish Obese Subjects (SOS study.

    Directory of Open Access Journals (Sweden)

    Maria Antonella Burza

    Full Text Available BACKGROUND AND AIM: Obesity is associated with elevated serum transaminase levels and non-alcoholic fatty liver disease and weight loss is a recommended therapeutic strategy. Bariatric surgery is effective in obtaining and maintaining weight loss. Aim of the present study was to examine the long-term effects of bariatric surgery on transaminase levels in obese individuals. METHODS: The Swedish Obese Subjects (SOS study is a prospective controlled intervention study designed to compare the long-term effects of bariatric surgery and usual care in obese subjects. A total of 3,570 obese participants with no excess of alcohol consumption at baseline (1,795 and 1,775 in the control and surgery group, respectively were included in the analyses. Changes in transaminase levels during follow-up were compared in the surgery and control groups. RESULTS: Compared to usual care, bariatric surgery was associated with lower serum ALT and AST levels at 2- and 10- year follow up. The reduction in ALT levels was proportional to the degree of weight loss. Both the incidence of and the remission from high transaminase levels were more favorable in the surgery group compared to the control group. Similarly, the prevalence of ALT/AST ratio <1 was lower in the surgery compared to the control group at both 2- and 10-year follow up. CONCLUSIONS: Bariatric surgery results in a sustained reduction in transaminase levels and a long-term benefit in obese individuals.

  7. African-American Women's Long-term Maintenance of Physical Activity Following a Randomized Controlled Trial.

    Science.gov (United States)

    Wilbur, JoEllen; Miller, Arlene M; Buchholz, Susan W; Fogg, Louis F; Braun, Lynne T; Halloway, Shannon; Schoeny, Michael E

    2017-07-01

    Our purpose was to determine long-term maintenance of physical activity (PA) following the 48-week Women's Lifestyle PA program, targeted/tailored for African-American women. The parent study consisted of a 3-arm randomized clinical trial with 3 assessment points: baseline (pre-intervention); 24 weeks post-baseline (end active intervention); and 48 weeks post-baseline (end maintenance intervention). Present analyses supplement the original results by adding a long-term maintenance assessment that occurred 2 to 4 years post-baseline. Participants were 288 African-American women aged 40 to 65 without major signs/symptoms of pulmonary/cardiovascular disease. The active intervention included 5 group meetings, with 9 personal motivational calls, 9 automated motivational calls, or no calls between meetings. The maintenance intervention included one group meeting and either 2 calls or no calls. PA was assessed with the Community Healthy Activities Model Program for Seniors. Retention was 90%. Over long-term maintenance, there was a decline in PA, but levels remained significantly higher than baseline for moderate/vigorous PA (p maintenance of PA increases resulting from group meetings in an active intervention occur when followed by a maintenance intervention.

  8. The Long-term Effect of Acupuncture for Migraine Prophylaxis: A Randomized Clinical Trial.

    Science.gov (United States)

    Zhao, Ling; Chen, Jiao; Li, Ying; Sun, Xin; Chang, Xiaorong; Zheng, Hui; Gong, Biao; Huang, Yinlan; Yang, Mingxiao; Wu, Xi; Li, Xuezhi; Liang, Fanrong

    2017-04-01

    The long-term prophylactic effects of acupuncture for migraine are uncertain. To investigate the long-term effects of true acupuncture compared with sham acupuncture and being placed in a waiting-list control group for migraine prophylaxis. This was a 24-week randomized clinical trial (4 weeks of treatment followed by 20 weeks of follow-up). Participants were randomly assigned to true acupuncture, sham acupuncture, or a waiting-list control group. The trial was conducted from October 2012 to September 2014 in outpatient settings at 3 clinical sites in China. A total of 249 participants 18 to 65 years old with migraine without aura based on the criteria of the International Headache Society, with migraine occurring 2 to 8 times per month. Participants in the true acupuncture and sham acupuncture groups received treatment 5 days per week for 4 weeks for a total of 20 sessions. Participants in the waiting-list group did not receive acupuncture but were informed that 20 sessions of acupuncture would be provided free of charge at the end of the trial. Participants used diaries to record migraine attacks. The primary outcome was the change in the frequency of migraine attacks from baseline to week 16. Secondary outcome measures included the migraine days, average headache severity, and medication intake every 4 weeks within 24 weeks. A total of 249 participants 18 to 65 years old were enrolled, and 245 were included in the intention-to-treat analyses. One hundred eighty-nine (77.1%) were women. Baseline characteristics were comparable across the 3 groups. The mean (SD) change in frequency of migraine attacks differed significantly among the 3 groups at 16 weeks after randomization (P acupuncture group by 3.2 (2.1), in the sham acupuncture group by 2.1 (2.5), and the waiting-list group by 1.4 (2.5); a greater reduction was observed in the true acupuncture than in the sham acupuncture group (difference of 1.1 attacks; 95% CI, 0.4-1.9; P = .002) and in the true

  9. Moderate- to long-term periodontal outcomes of subjects failing to complete a course of periodontal therapy.

    Science.gov (United States)

    Goh, V; Hackmack, P P; Corbet, E F; Leung, W K

    2017-06-01

    The current retrospective cross-sectional study investigated 5-18-year treatment outcomes in subjects who did not complete a recommended course of periodontal therapy. Sixty-five subjects who voluntarily discontinued therapy were recalled. The subjects' demographic data and dental history since discontinuation of periodontal treatment were collected via questionnaires. The subjects' periodontal condition, radiographic data and individual tooth-based prognosis at pre-discontinuation and recall were compared. A total of 229 teeth had been lost over time, mainly due to periodontal reasons. Upper and lower molars were most frequently lost. Rate of tooth loss (0.38/patient per year) was comparable to untreated patients. Deterioration in periodontal health in terms of increased percentage of sites with bleeding on probing (BOP) and sites with probing pocket depths (PPD) of 6 mm or more at re-examination was observed. Positive correlations were found between tooth loss and: (i) years since therapy discontinued; (ii) percentage of sites with PPD of 6 mm or more at pre-discontinuation; and (iii) at re-examination. Percentage of sites with PPD of 6 mm or more at recall was positively correlated with periodontal tooth loss and negatively correlated with percentage of sites without BOP. Patients not completing a course of periodontal therapy are at risk of further tooth loss and deterioration in periodontal conditions over time. © 2016 Australian Dental Association.

  10. 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

  11. 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

  12. 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

  13. THE SHORT-TERM EFFECT OF A HOME-BASED PROGRAM TO CORRECT FORWARD HEAD POSTURE IN ASYMPTOMATIC SUBJECTS

    Directory of Open Access Journals (Sweden)

    Ahmed Omar Abdelnaeem

    2015-08-01

    Full Text Available Background: Neck pain and dysfunction may be the consequence of adopting sustained non-neutral spinal postures. Such postures are associated with increased activation of the neck-shoulder stabilizer muscles, which eventually increase the loading of cervical spine. Forward head posture is a common postural dysfunction that has been associated with many musculoskeletal disorders. The purpose of the study was to investigate the effects of deep cervical flexor muscles training on the severity of forward head posture in asymptomatic subjects. Methods: Forty-one asymptomatic subjects volunteered in this study. Participants were randomly assigned into an intervention group (n= 20that received a home-based training of deep cervical flexor muscles for 6-weeks, and a control group(n= 21 that received only the assessment procedure. Subjects were assessed at baseline and 6weeks later with regards to the severity of forward head as indicated by the cranio-vertebral angle. Also, the strength and endurance of the deep flexor muscles were assessed. Results: After six weeks, participants in the intervention group showed significant improvement in all measured variables compared to the control group. Furthermore, participants in the intervention group showed significant difference in all measured variables after 6-weeks of training compared to baseline, whereas those in the control group remained the same. Conclusion: Six-weeks of deep cervical training improves forward head posture and deep flexors strength and endurance in asymptomatic subjects. Thus, this exercise could be used as a preventive measure against the development of neck dysfunction in at risk population even before the onset of any symptoms.

  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. Combination therapy containing ritonavir plus saquinavir has superior short-term antiretroviral efficacy: a randomized trial

    DEFF Research Database (Denmark)

    Kirk, O; Katzenstein, T L; Gerstoft, J

    1999-01-01

    trial. Two hundred and eighty-four patients started randomized treatment. The primary end-point was the proportion of patients with HIV RNA of 200 copies/ml or less (Roche Amplicor) and HIV RNA of 20 copies/ml or less (Roche ultradirect assay) at 6 months. Analysis was performed as intent......-to-treat, and missing values were accounted for as failures. RESULTS: As of 1 May 1998, 269 patients should have completed 24 weeks of treatment. The proportion of patients with HIV RNA of 200 copies/ml or less was 71% (indinavir), 67% (ritonavir), and 82% (ritonavir + saquinavir), P = 0.07. In antiretroviral drug...... is generally safe, and has superior short-term antiviral efficacy compared with indinavir and ritonavir also combined with two nucleoside analogues in antiretroviral drug-naive patients. Further follow-up is needed to determine the durability of the viral response....

  16. Efficacy of short-term adjunctive subantimicrobial dose doxycycline in diabetic patients--randomized study.

    Science.gov (United States)

    Gilowski, L; Kondzielnik, P; Wiench, R; Płocica, I; Strojek, K; Krzemiński, T F

    2012-11-01

    To investigate the effectiveness of short-term adjunctive subantimicrobial dose doxycycline (SDD) treatment in patients with diabetes mellitus type 2 and chronic periodontitis (CP). Thirty-four patients with CP and type 2 diabetes mellitus were included in the placebo-controlled, double-blind study. After scaling and root planing (SRP), patients were randomly assigned to two groups, receiving either SDD or placebo bid for 3 months. The probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), approximal plaque index, glycated hemoglobin (HbA1c) level were recorded and gingival crevicular fluid (GCF) samples were collected at baseline and after 3-month therapy for the estimation of matrix metalloproteinase-8 levels. Clinical attachment level, PD, and BOP improved significantly in both groups after therapy (P diabetes and CP. © 2012 John Wiley & Sons A/S.

  17. Impaired basal glucose effectiveness but unaltered fasting glucose release and gluconeogenesis during short-term hypercortisolemia in healthy subjects

    DEFF Research Database (Denmark)

    Nielsen, Michael F; Caumo, Andrea; Chandramouli, Visvanathan

    2004-01-01

    Excess cortisol has been demonstrated to impair hepatic and extrahepatic insulin action. To determine whether glucose effectiveness and, in terms of endogenous glucose release (EGR), gluconeogenesis, also are altered by hypercortisolemia, eight healthy subjects were studied after overnight infusion...... contribution of gluconeogenesis to EGR (P = 0.33) did not differ on the two study days. During the prandial glucose infusion, the integrated glycemic response above baseline was higher in the presence of hydrocortisone than during saline infusion (P .... In conclusion, short-term hypercortisolemia in healthy individuals with normal beta-cell function decreases insulin action but does not alter rates of EGR and gluconeogenesis. In addition, cortisol impairs the ability of glucose to suppress its own production, which due to accumulation of glucose in the glucose...

  18. Short-term effects of a randomized controlled worksite relaxation intervention in Greece

    Directory of Open Access Journals (Sweden)

    Evangelos C Alexopoulos

    2014-06-01

    Full Text Available objective. To evaluate the short-term benefits of simple relaxation techniques in white-collar employees. materials and methods. The study was a two-arm parallel group randomized controlled trial. 152 employees were randomly assigned to receive the 8-week programme (N=80 (relaxation breathing and progressive muscle relaxation, twice a day or not (wait-list group N=72. Self-reported validated measures were used to evaluate perceived stress, health locus of control, job and lifestyle related variables. Saliva cortisol were also sampled and measured. Adjusted mean changes on outcomes were estimated by linear mixed model analysis. 127 employees were finally analyzed (68 in the intervention and 59 in the control group. results. Specific stress-related symptoms, psychological job demands and cortisol levels were found to be significantly decreased after 8-weeks in the intervention group. The result was probably affected by the general socio-economic condition during the study period. Cortisol levels were also significantly related with age, family situation, gender and sampling time. conclusions. Simple relaxation training (diaphragmatic breathing and progressive muscle relaxation could benefit employees and it is strongly proposed that these and other similar techniques should be tested in various labour settings

  19. Predictors of long-term benzodiazepine abstinence in participants of a randomized controlled benzodiazepine withdrawal program.

    Science.gov (United States)

    Voshaar, Richard C Oude; Gorgels, Wim J; Mol, Audrey J; van Balkom, Anton J; Mulder, Jan; van de Lisdonk, Eloy H; Breteler, Marinus H; Zitman, Frans G

    2006-06-01

    To identify predictors of resumed benzodiazepine use after participation in a benzodiazepine discontinuation trial. We performed multiple Cox regression analyses to predict the long-term outcome of a 3-condition, randomized, controlled benzodiazepine discontinuation trial in general practice. Of 180 patients, we completed follow-up for 170 (94%). Of these, 50 (29%) achieved long-term success, defined as no use of benzodiazepines during follow-up. Independent predictors of success were as follows: offering a taper-off program with group therapy (hazard ratio [HR] 2.4; 95% confidence interval [CI], 1.5 to 3.9) or without group therapy (HR 2.9; 95% CI, 1.8 to 4.8); a lower daily benzodiazepine dosage at the start of tapering off (HR 1.5; 95% CI, 1.2 to 1.9); a substantial dosage reduction by patients themselves just before the start of tapering off (HR 2.1; 95% CI, 1.4 to 3.3); less severe benzodiazepine dependence, as measured by the Benzodiazepine Dependence Self-Report Questionnaire Lack of Compliance subscale (HR 2.4; 95%CI, 1.1 to 5.2); and no use of alcohol (HR 1.7; 95% CI, 1.2 to 2.5). Patients who used over 10 mg of diazepam equivalent, who had a score of 3 or more on the Lack of Compliance subscale, or who drank more than 2 units of alcohol daily failed to achieve long-term abstinence. Benzodiazepine dependence severity affects long-term taper outcome independent of treatment modality, benzodiazepine dosage, psychopathology, and personality characteristics. An identifiable subgroup needs referral to specialized care.

  20. Effect of Probiotics on Serum Bilirubin Level in Term Neonates with Jaundice; A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Yadollah Zahed Pasha

    2017-10-01

    Full Text Available Background In recent years, tendency to use drugs has been increasing in the treatment of neonatal jaundice. Several drugs have been used since then, but the effect of probiotics on serum bilirubin level (SBL is not so clear. This study was conducted to evaluate the effect of probiotics on SBL and the duration of phototherapy in term neonates with hyperbilirubinemia. Materials and Methods: In this randomized clinical trial, we studied 150 term neonate with jaundice hospitalized for phototherapy in Amirkola Children’s Hospital, Babol- Iran, during October 5, 2016 till May 19, 2017. Eligible neonates were randomly divided into two; intervention (n=75, and control (n=75 groups. Both groups received standard conventional phototherapy, but the intervention group received 10 drop/day of probiotics (Pedilact Zisttakhmir. Co. Iran, until hospital discharge. The outcome variables were SBL and the duration of phototherapy. The data was analyzed by SPSS 22.0 and   the P 0.05.After 24, 48 and 72hours it decreased to 13.73±1.72, 10.92±1.87 and 10.25±1.32 in the intervention and 13.66±1.91, 11.01±1.69 and10.09 ±1.38 in the control groups, respectively but comparison of the amount of SBL reduction  between the two groups was not significant (P>0.05. The duration of phototherapy in the intervention group and the control group was 3.61±1.17 days and 3.72±1.18 days respectively (P>0.05. Conclusion Oral probiotics in neonates with jaundice has no significant effect on SBL and the duration of phototherapy. Further studies are needed to with longer time follow-up.

  1. Immediate and short-term pain relief by acute sciatic nerve press: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Zhang Wenlong

    2007-05-01

    Full Text Available Abstract Background Despite much research, an immediately available, instantly effective and harmless pain relief technique has not been discovered. This study describes a new manipulation: a "2-minute sciatic nerve press", for rapid short-term relief of pain brought on by various dental and renal diseases. Methods This randomized, single-blind, placebo-controlled trial ran in three hospitals in Anhui Province, China, with an enrollment of 66 out of 111 solicited patients aged 16 to 74 years. Patients were recruited sequentially, by specific participating physicians at their clinic visits to three independent hospitals. The diseases in enrolled dental patients included dental caries, periodontal diseases and dental trauma. Renal diseases in recruits included kidney infections, stones and some other conditions. Patients were randomly assigned to receive the "2-minute sciatic nerve press" or the "placebo press". For the "2-minute sciatic nerve press", pressure was applied simultaneously to the sciatic nerves at the back of the thighs, using the fists while patients lay prone. For the "placebo press", pressure was applied simultaneously to a parallel spot on the front of the thighs, using the fists while patients lay supine. Each fist applied a pressure of 11 to 20 kg for 2 minutes, after which, patients arose to rate pain. Results The "2-minute sciatic nerve press" produced greater pain relief than the "placebo press". Within the first 10 minutes after sciatic pressure, immediate pain relief ratings averaged 66.4% (p Conclusion Two minutes of pressure on both sciatic nerves can produce immediate significant conduction analgesia, providing a convenient, safe and powerful way to overcome clinical pain brought on by dental diseases and renal diseases for short term purposes. Trial registration ACTR 12606000439549

  2. The long-term effects of bibliotherapy in depression treatment: Systematic review of randomized clinical trials.

    Science.gov (United States)

    Gualano, M R; Bert, F; Martorana, M; Voglino, G; Andriolo, V; Thomas, R; Gramaglia, C; Zeppegno, P; Siliquini, R

    2017-12-01

    Literature shows bibliotherapy can be helpful for moderate depression treatment. The aim of this systematic review is to verify the long-term effects of bibliotherapy. After bibliographic research, we included RCTs articles about bibliotherapy programme treatment of depression published in English language between 1990 and July 2017. All RCTs were assessed with Cochrane's Risk of Bias tool. Ten articles (reporting 8 studies involving 1347 subjects) out of 306 retrieved results were included. All studies analyze the effects of bibliotherapy after follow-up periods ranging from 3months to 3years and show quiet good quality in methods and analyses. The treatment was compared to standard treatments or no intervention in all studies. After long-term period follow-ups, six studies, including adults, reported a decrease of depressive symptoms, while four studies including young people did not show significant results. Bibliotherapy appears to be effective in the reduction of adults depressive symptoms in the long-term period, providing an affordable prompt treatment that could reduce further medications. The results of the present review suggest that bibliotherapy could play an important role in the treatment of a serious mental health issue. Further studies should be conducted to strengthen the evidence of bibliotherapy's efficacy. Copyright © 2017 Elsevier Ltd. All rights reserved.

  3. Short-term aerobic exercise and vascular function in CKD stage 3: a randomized controlled trial.

    Science.gov (United States)

    Headley, Samuel; Germain, Michael; Wood, Richard; Joubert, Jyovani; Milch, Charles; Evans, Elizabeth; Poindexter, Anthony; Cornelius, Allen; Brewer, Britton; Pescatello, Linda S; Parker, Beth

    2014-08-01

    The present study was designed to determine the effect of short-term moderate-intensity exercise training on arterial stiffness in patients with chronic kidney disease (CKD) stage 3. Randomized controlled trial with a parallel-group design. Testing and training sessions were performed at Springfield College. 46 (treatment group, n=25; control group, n=21) patients with CKD with diabetes and/or hypertension completed the study. The aerobic training program consisted of 16 weeks of supervised exercise training at 50%-60% peak oxygen uptake (Vo2peak) 3 times per week, while the control group remained sedentary. Identical testing procedures were performed following the 16-week intervention. The primary outcome was arterial stiffness. Secondary outcomes were aerobic capacity, various blood parameters (endothelin 1, nitrate/nitrite, and high-sensitivity C-reactive protein), and health-related quality of life. Arterial stiffness was assessed with aortic pulse wave velocity (PWV), aerobic capacity by Vo2peak, blood parameters by enzyme-linked immunosorbent assays, and health-related quality of life by the 36-Item Short Form Health Survey (SF-36). Participants attended 4 sessions before being randomly assigned to either the treatment or control group. Participants gave consent during the first session, whereas a graded exercise test with measurement of Vo2peak was completed during the second session. During sessions 3 and 4, aortic PWV was measured at rest prior to 40 minutes of either moderate-intensity exercise training or seated rest. A venous blood sample was obtained prior to exercise or rest and participants completed the SF-36 questionnaire. 16 weeks of training led to an 8.2% increase in Vo2peak for the treatment group (P=0.05), but no changes in aortic PWV . Randomization was not concealed and was violated on one occasion; also, use of an indirect measurement of endothelial function and the short duration of the intervention. Short-term moderate-intensity exercise

  4. 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

  5. Middle-Term Dietary Supplementation with Red Yeast Rice Plus Coenzyme Q10 Improves Lipid Pattern, Endothelial Reactivity and Arterial Stiffness in Moderately Hypercholesterolemic Subjects.

    Science.gov (United States)

    Cicero, Arrigo F G; Morbini, Martino; Rosticci, Martina; D''Addato, Sergio; Grandi, Elisa; Borghi, Claudio

    2016-01-01

    The aim of our study was to investigate whether treatment with red yeast rice added with Coenzyme Q10 is associated with changes in endothelial function and arterial stiffness. This double blind, placebo-controlled, randomized clinical trial was carried out on 40 non-smoker moderately hypercholesterolemic subjects (ClinicalTrial.gov ID NCT02492464). After 4 weeks of diet and physical activity, patients were allocated to treatment with placebo or with an active product containing 10 mg monacolins and 30 mg Coenzyme Q10, to be assumed for 6 months. Endothelial reactivity and arterial stiffness have been measured through the validated Vicorder® device. During monacolin treatment, patients experienced a more favorable percentage change in low density lipoprotein (LDL)-cholesterol (after monacolin treatment: -26.3%; after placebo treatment: +3.4%, p < 0.05). Endothelial reactivity (pulse volume displacement after monacolin treatment: +6.0%; after placebo treatment: -0.3%, p < 0.05), and arterial stiffness (pulse wave velocity (PWV) after monacolin treatment: -4.7%; after placebo: +1.1%, p < 0.05) also significantly improved only after monacolin treatment. The long-term assumption of the tested dietary supplement is associated with an improvement in LDL-cholesterolemia, endothelial reactivity and PWV in moderately hypercholesterolemic subjects. © 2016 S. Karger AG, Basel.

  6. 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.

  7. Stature and long-term labor market outcomes: Evidence using Mendelian randomization.

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    Böckerman, Petri; Viinikainen, Jutta; Vainiomäki, Jari; Hintsanen, Mirka; Pitkänen, Niina; Lehtimäki, Terho; Pehkonen, Jaakko; Rovio, Suvi; Raitakari, Olli

    2017-02-01

    We use the Young Finns Study (N=∼2000) on the measured height linked to register-based long-term labor market outcomes. The data contain six age cohorts (ages 3, 6, 9, 12, 15 and 18, in 1980) with the average age of 31.7, in 2001, and with the female share of 54.7. We find that taller people earn higher earnings according to the ordinary least squares (OLS) estimation. The OLS models show that 10cm of extra height is associated with 13% higher earnings. We use Mendelian randomization, with the genetic score as an instrumental variable (IV) for height to account for potential confounders that are related to socioeconomic background, early life conditions and parental investments, which are otherwise very difficult to fully account for when using covariates in observational studies. The IV point estimate is much lower and not statistically significant, suggesting that the OLS estimation provides an upward biased estimate for the height premium. Our results show the potential value of using genetic information to gain new insights into the determinants of long-term labor market success. Copyright © 2016 Elsevier B.V. All rights reserved.

  8. Effects of short-term treatment with atorvastatin in smokers with asthma - a randomized controlled trial

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    Lloyd Suzanne M

    2011-04-01

    Full Text Available Abstract Background The immune modulating properties of statins may benefit smokers with asthma. We tested the hypothesis that short-term treatment with atorvastatin improves lung function or indices of asthma control in smokers with asthma. Methods Seventy one smokers with mild to moderate asthma were recruited to a randomized double-blind parallel group trial comparing treatment with atorvastatin (40 mg per day versus placebo for 4 weeks. After 4 weeks treatment inhaled beclometasone (400 μg per day was added to both treatment arms for a further 4 weeks. The primary outcome was morning peak expiratory flow after 4 weeks treatment. Secondary outcome measures included indices of asthma control and airway inflammation. Results At 4 weeks, there was no improvement in the atorvastatin group compared to the placebo group in morning peak expiratory flow [-10.67 L/min, 95% CI -38.70 to 17.37, p = 0.449], but there was an improvement with atorvastatin in asthma quality of life score [0.52, 95% CI 0.17 to 0.87 p = 0.005]. There was no significant improvement with atorvastatin and inhaled beclometasone compared to inhaled beclometasone alone in outcome measures at 8 weeks. Conclusions Short-term treatment with atorvastatin does not alter lung function but may improve asthma quality of life in smokers with mild to moderate asthma. Trial Registration Clinicaltrials.gov identifier: NCT00463827

  9. Long-Term Chamomile Therapy of Generalized Anxiety Disorder: A Study Protocol for a Randomized, Double-Blind, Placebo- Controlled Trial.

    Science.gov (United States)

    Mao, Jun J; Li, Qing S; Soeller, Irene; Rockwell, Kenneth; Xie, Sharon X; Amsterdam, Jay D

    2014-11-01

    Anxiety symptoms are among the most common reasons for consumers to use Complementary and Alternative Medicine (CAM) therapy. Although many botanicals have been proposed as putative remedies for anxiety symptoms, there has been a paucity of controlled trials of these remedies. A preliminary study of the anxiolytic effect of Chamomile (Matricaria recutita) in humans suggests that chamomile may have anxiolytic and antidepressant activity. We now seek to conduct a 5-year randomized, double-blind, placebo-substitution study to examine the short and long-term safety and efficacy of chamomile extract in Generalized Anxiety Disorder (GAD). 180 subjects with moderate to severe GAD will receive initial open-label pharmaceutical-grade chamomile extract 500-1,500 mg daily for 8 weeks. Responders to treatment who remain well for an additional 4 weeks of consolidation therapy, will be randomized to double-blind continuation therapy with either chamomile extract 500-1,500 mg daily or placebo for an additional 26 weeks. The primary outcome will be the time to relapse during study continuation therapy in each treatment condition. Secondary outcomes will include the proportion of subjects in each treatment condition who relapse, as well as the proportion of subjects with treatment-emergent adverse events. Quality of life ratings will also be compared between treatment conditions during short and long-term therapy. Many individuals with mental disorders decline conventional therapy and seek CAM therapies for their symptoms. Thus, the identification of effective CAM therapy is of relevance to reducing the burden of mental illness. This study builds upon our prior findings of significant superiority of chamomile versus placebo in reducing GAD symptoms. We now extend these preliminary findings by conducting a randomized long-term safety and efficacy study of chamomile in GAD.

  10. Effects of long-term soft contact lens wear on the corneal thickness and corneal epithelial thickness of myopic subjects.

    Science.gov (United States)

    Lei, Yulin; Zheng, Xiuyun; Hou, Jie; Xu, Baozeng; Mu, Guoying

    2015-03-01

    To perform safe and successful corneal refractive surgery on myopic patients, corneal thickness (CT) and corneal epithelial thickness (CET) must be accurately measured. Numerous individuals with myopia wear soft contact lenses (SCLs) for the correction of visual acuity but may subsequently undergo corneal refractive surgery. The aim of the present study was therefore to investigate the effects of long-term SCL wear on the CT and the CET of myopic subjects in order to guarantee the safety and accuracy of subsequent corneal refractive surgeries. Fifty-six subjects prepared to receive refractive surgery at Jinan Mingshui Eye Hospital (Zhangqiu, China) from April to July 2013 were included in the study. CT and CET were measured in subjects immediately following discontinued SCL wear (group I, 56 eyes), and subsequently following >two weeks of discontinued SCL wear (group II, 56 eyes). Ninety-four subjects with no history of corneal contact lens wear were enrolled as a control group. The CT and CET were measured at positions with a radius of 0.0‑1.0, 1.0-2.5 (divided into eight quadrants) and 2.5-3.0 mm (divided into eight quadrants) away from the corneal center using the RTVue-100 Fourier-domain anterior segment optical coherence tomography system. A significant decrease in the CT of the subjects in group II was observed, compared with that of group I and the control group (P<0.05). A significant decrease was observed in the CET of groups I and II compared with that of the control group (P<0.05). Following discontinuation of SCL wear, CET increased. However, the increased CET was unable to reach the normal range exhibited by the control group. Edema and thinning of the corneal stroma, as well as thinning of the corneal epithelium were observed in groups I and II. In conclusion, it was proposed that in clinical practice, for myopic patients following long-term SCL wear, CT and CET should be determined ≥ two weeks following discontinuation of SCL wear, once a stable

  11. 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.

  12. 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.

  13. Long-term indoor air conditioner filtration and cardiovascular health: A randomized crossover intervention study.

    Science.gov (United States)

    Chuang, Hsiao-Chi; Ho, Kin-Fai; Lin, Lian-Yu; Chang, Ta-Yuan; Hong, Gui-Bing; Ma, Chi-Ming; Liu, I-Jung; Chuang, Kai-Jen

    2017-09-01

    The association of short-term air pollution filtration with cardiovascular health has been documented. However, the effect of long-term indoor air conditioner filtration on the association between air pollution and cardiovascular health is still unclear. We recruited 200 homemakers from Taipei and randomly assigned 100 of them to air filtration or control intervention; six home visits were conducted per year from 2013 to 2014. The participants under air filtration intervention during 2013 were reassigned to control intervention in 2014. The air pollution measurements consisted of particulate matter less than or equal to 2.5μm in diameter (PM 2.5 ) and total volatile organic compounds (VOCs); blood pressure was monitored for each participant during each visit. The following morning, blood samples were collected after air pollution monitoring. The blood samples were used to analyze biological markers, including high sensitivity-C-reactive protein (hs-CRP), 8-hydroxy-2'-deoxyguanosine (8-OHdG) and fibrinogen. Household information, including cleaning, cooking, and air conditioning, was collected by a questionnaire. Mixed-effects models were used to investigate the associations among air pollution measurements, blood pressure and biological markers. The results showed that increased levels of PM 2.5 and total VOCs were associated with increased hs-CRP, 8-OHdG and blood pressure. The health variables were higher among participants in the control intervention phase than among those in the air filtration intervention phase. We concluded that air pollution exposure was associated with systemic inflammation, oxidative stress and elevated blood pressure. The long-term filtration of air pollution with an air conditioner filter was associated with cardiovascular health of adults. Copyright © 2017 Elsevier Ltd. All rights reserved.

  14. 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

  15. 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

  16. 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.

  17. Effect of Talbinah food consumption on depressive symptoms among elderly individuals in long term care facilities, randomized clinical trial

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    Badrasawi MM

    2013-03-01

    Full Text Available Manal M Badrasawi, Suzana Shahar, Zahara Abd Manaf, Hasnah HaronDietetics program, School of Health Care Sciences, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur, MalaysiaAbstract: Talbinah is a barley syrup cooked with milk and sweetened by honey. In his famous Hadith on Talbinah, the Prophet Mohammad (SAW recommended it when sad events happen for its effect on soothing hearts and relieving sadness. This 3-week crossover designed, randomized clinical trial was conducted to determine the effect of Talbinah on mood and depression among institutionalized elderly people in Seremban. A sample of 30 depressed elderly subjects (21 men and 9 women was selected from the long term care facility. Three different interview-based validated scales (Geriatric Depression Scale, Depression Anxiety Stress Scales, and Profile of Mood States were used to determine mood, depression, stress, and anxiety at week 0, 3, 4, and 7. The nutritional value of Talbinah was examined using proximate food analysis, minerals content analysis, and differential amino acid analysis. The results indicated that Talbinah is a high carbohydrate food (86.4% and has a high tryptophan: branch chain amino acids ratio (1:2. A Wilcoxon nonparametric test showed that there was a statistically significant decrease on depression, stress, and mood disturbances scores among the intervention group (P < 0.05 for all parameters. In conclusion, Talbinah has the potential to reduce depression and enhance mood among the subjects. Ingestion of functional foods such as Talbinah may provide a mental health benefit to elderly people.Keywords: Talbinah, food and depression, cross over study, elderly

  18. Long-term Follow-up of a Randomized Controlled Trial Comparing Scarf to Chevron Osteotomy in Hallux Valgus Correction.

    Science.gov (United States)

    Jeuken, Ralph M; Schotanus, Martijn G M; Kort, Nanne P; Deenik, Axel; Jong, Bob; Hendrickx, Roel P M

    2016-07-01

    Hallux valgus is one of the most common foot deformities. This long-term follow-up study compared the results of 2 widely used operative treatments for hallux valgus: the scarf and chevron osteotomy. Conventional weight bearing anteroposterior (AP) radiographs of the foot were made for evaluating the intermetatarsal angle and hallux valgus angle. For clinical evaluation, the American Orthopaedic Foot & Ankle Society (AOFAS) rating system for the hallux metatarsophalangeal-interphalangeal scale was used together with physical examination of the foot. These data were compared with the results from the original study. The Short Form 36 questionnaire, the Manchester-Oxford Foot Questionnaire (MOXFQ), and a general questionnaire including a visual analog scale (VAS) pain score were used for subjective evaluation. The primary outcome measures were the radiologic recurrence of hallux valgus and reoperation rate of the same toe. Secondary outcome measures were the results from the radiographs and subjective and clinical evaluation. The response rate was 76% at the follow-up of 14 years; in the chevron group, 37 feet were included compared with 36 feet in the scarf group. Twenty-eight feet in the chevron group and 27 in the scarf group developed recurrence of hallux valgus (P = .483). One patient in the scarf group had a reoperation of the same toe compared with none in the chevron group (P = .314). Current VAS pain scores and results from the SF-36, MOXFQ, and AOFAS did not significantly differ between groups. Both techniques showed similar results after 2 years of follow-up. At 14 years of follow-up, neither technique was superior in preventing recurrence. Level II, randomized controlled trial. © The Author(s) 2016.

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

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    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.

  20. 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

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

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    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.

  2. Fel d 1-derived synthetic peptide immuno-regulatory epitopes show a long-term treatment effect in cat allergic subjects.

    Science.gov (United States)

    Couroux, P; Patel, D; Armstrong, K; Larché, M; Hafner, R P

    2015-05-01

    Cat-PAD, the first in a new class of synthetic peptide immuno-regulatory epitopes (SPIREs), was shown to significantly improve rhinoconjunctivitis symptoms in subjects with cat allergy up to 1 year after the start of a short course of treatment. To evaluate the long-term effects of Cat-PAD on rhinoconjunctivitis symptoms following standardized allergen challenge 2 years after treatment. In a randomized, double-blind, placebo-controlled, parallel group study, subjects were exposed to cat allergen in an environmental exposure chamber (EEC) before and after treatment with two regimens of Cat-PAD (either eight doses of 3 nmol or four doses of 6 nmol) given intradermally over a 3-month period. In this follow-up study, changes from baseline in rhinoconjunctivitis symptoms were reassessed 2 years after the start of treatment. The primary endpoint showed a mean reduction in total rhinoconjunctivitis symptom scores of 3.85 units in the 4 × 6 nmol Cat-PAD group compared to placebo 2 years after the start of treatment (P = 0.13), and this difference was statistically significant in the secondary endpoint at the end of day 4 when the cumulative allergen challenge was greatest (P = 0.02). Consistent reductions in nasal symptoms of between 2 and 3 units were observed for 4 × 6 nmol Cat-PAD compared to placebo between the 2 and 3 h time points on days 1-4 of EEC challenge at 2 years (P Cat-PAD. This study is the first to provide evidence of a long-term therapeutic effect with this new class of SPIREs. © 2015 The Authors. Clinical & Experimental Allergy Published by John Wiley & Sons Ltd.

  3. Tai Chi for treating knee osteoarthritis: Designing a long-term follow up randomized controlled trial

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    Rones Ramel

    2008-07-01

    Full Text Available Abstract Background Knee Osteoarthritis (KOA is a major cause of pain and functional impairment among elders. Currently, there are neither feasible preventive intervention strategies nor effective medical remedies for the management of KOA. Tai Chi, an ancient Chinese mind-body exercise that is reported to enhance muscle function, balance and flexibility, and to reduce pain, depression and anxiety, may safely and effectively be used to treat KOA. However, current evidence is inconclusive. Our study examines the effects of a 12-week Tai Chi program compared with an attention control (wellness education and stretching on pain, functional capacity, psychosocial variables, joint proprioception and health status in elderly people with KOA. The study will be completed by July 2009. Methods/Design Forty eligible patients, age > 55 yr, BMI ≤ 40 kg/m2 with tibiofemoral osteoarthritis (American College of Rheumatology criteria are identified and randomly allocated to either Tai Chi (10 modified forms from classical Yang style Tai Chi or attention control (wellness education and stretching. The 60-minute intervention sessions take place twice weekly for 12 weeks. The study is conducted at an urban tertiary medical center in Boston, Massachusetts. The primary outcome measure is the Western Ontario and McMaster Universities (WOMAC pain subscale at 12 weeks. Secondary outcomes include weekly WOMAC pain, function and stiffness scores, patient and physician global assessments, lower-extremity function, knee proprioception, depression, self-efficacy, social support, health-related quality of life, adherence and occurrence of adverse events after 12, 24 and 48 weeks. Discussion In this article, we present the challenges of designing a randomized controlled trial with long-term follow up. The challenges encountered in this design are: strategies for recruitment, avoidance of selection bias, the actual practice of Tai Chi, and the maximization of adherence

  4. Effect of multisensory stimulation on analgesia in term neonates: a randomized controlled trial.

    Science.gov (United States)

    Bellieni, Carlo Valerio; Bagnoli, Franco; Perrone, Serafina; Nenci, Anna; Cordelli, Duccio Maria; Fusi, Mara; Ceccarelli, Simona; Buonocore, Giuseppe

    2002-04-01

    Many attempts have been made to obtain safe and effective analgesia in newborns. Oral glucose-water has been found to have analgesic properties in neonates. We investigated whether other sensory stimulation added to oral glucose provided more effective analgesia than oral glucose alone. In a randomized prospective double-blind trial, we studied 120 term newborns during heel prick. The babies were divided randomly into six groups of 20, and each group was treated with a different procedure during heel prick: A) control; B) 1 mL 33% oral glucose given 2 min before the heel prick; C) sucking; D) 1 mL 33% oral glucose plus sucking; E) multisensory stimulation including 1 mL 33% oral glucose (sensorial saturation); F) multisensory stimulation without oral glucose. Sensorial saturation consisted in massage, voice, eye contact, and perfume smelling during heel prick. Each heel prick was filmed and assigned a point score according to the Douleur Aiguë du Nouveau-né (DAN) neonatal acute pain scale. Camera recording began 30 s before the heel prick, so it was impossible for the scorers to distinguish procedure A (control) from B (glucose given 2 min before), C (sucking water) from D (sucking glucose), and E (multisensory stimulation and glucose) from F (multisensory stimulation and water) from the video. Procedure E (multisensory stimulation and glucose) was found to be the most effective procedure, and the analgesia was even more effective than that produced by procedure D (sucking glucose). We conclude that sensorial saturation is an effective analgesic technique that potentiates the analgesic effect of oral sugar. It can be used for minor painful procedures on newborns.

  5. Short-Term Effects of Thoracic Spine Manipulation on Shoulder Impingement Syndrome: A Randomized Controlled Trial.

    Science.gov (United States)

    Haik, Melina N; Alburquerque-Sendín, Francisco; Camargo, Paula R

    2017-08-01

    To investigate the short-term effects of thoracic spine manipulation (TSM) on pain, function, scapular kinematics, and scapular muscle activity in individuals with shoulder impingement syndrome. Randomized controlled trial with blinded assessor and patient. Laboratory. Patients with shoulder impingement syndrome (N=61). Participants were randomly allocated to TSM group (n=30) or sham-TSM group (n=31) and attended 2 intervention sessions over a 1-week period. Scapular kinematics and muscle activity were measured at day 1 (baseline, before the first intervention), day 2 preintervention (before second intervention), day 2 postintervention (after the second intervention), and day 3 (follow-up). Shoulder pain and function were assessed by the Disability of the Arm, Shoulder and Hand questionnaire and Western Ontario Rotator Cuff Index at baseline, day 2 preintervention, and follow-up. An assessor blinded to group assignment measured all outcomes. Pain decreased by 0.7 points (95% confidence interval, 1.3-0.1 points) at day 2 preintervention and 0.9 points (95% confidence interval, 1.5-0.3 points) at day 2 postintervention in the TSM group. The Disability of the Arm, Shoulder and Hand questionnaire (P=.01) and Western Ontario Rotator Cuff Index (P=.02) scores improved in both groups. Scapular upward rotation increased during arm lowering (PTSM group. Upper trapezius activity increased (PTSM group. Middle trapezius, lower trapezius, and serratus anterior decreased activities in both groups during elevation and lowering of the arm. TSM may increase scapular upward rotation during arm lowering. TSM does not seem to influence activity of the scapular muscles. The results concerning shoulder pain, function, scapular tilt, and internal rotation are not conclusive. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  6. Virgin olive oil supplementation and long-term cognition: the PREDIMED-NAVARRA randomized, trial.

    Science.gov (United States)

    Martínez-Lapiscina, E H; Clavero, P; Toledo, E; San Julián, B; Sanchez-Tainta, A; Corella, D; Lamuela-Raventós, R M; Martínez, J A; Martínez-Gonzalez, M Á

    2013-01-01

    To assess the effect on cognition of a controlled intervention testing Mediterranean diets (MedDiet). Randomized trial after 6.5 years of nutritional intervention. Eight primary care centers affiliated to the University of Navarra. A random subsample of 285 participants (95 randomly allocated to each of 3 groups) of the PREDIMED-NAVARRA trial. All of them were at high vascular risk (44.8% men, 74.1±5.7 years at cognitive evaluation). Nutritional intervention comparing two MedDiets (supplemented with extra-virgin olive oil [EVOO] or mixed nuts) versus a low-fat control diet. Participants received intensive education to increase adherence to the intended intervention. Participants allocated to the MedDiet groups received EVOO (1 l/week) or 30 g/day of mixed nuts. Dietary habits were evaluated using a validated 137-item food frequency questionnaire (FFQ). Additionally, adherence to MedDiet was appraised using a 14-item questionnaire both at baseline and yearly thereafter. Cognitive performance as a main outcome and cognitive status (normal, mild cognitive impairment [MCI] or dementia) as a secondary outcome were evaluated by two neurologists blinded to group assignment after 6.5 years of nutritional intervention. Better post-trial cognitive performance versus control in all cognitive domains and significantly better performance across fluency and memory tasks were observed for participants allocated to the MedDiet+EVOO group. After adjustment for sex, age, education, apolipoprotein E genotype, family history of cognitive impairment/dementia, smoking, physical activity, body mass index, hypertension, dyslipidaemia, diabetes, alcohol and total energy intake, this group also showed lower MCI (OR=0.34 95% CI: 0.12-0.97) compared with control group. Participants assigned to MedDiet+Nuts group did not differ from controls. A long-term intervention with an EVOO-rich MedDiet resulted in a better cognitive function in comparison with a control diet. However, non

  7. Long-term chamomile (Matricaria chamomilla L.) treatment for generalized anxiety disorder: A randomized clinical trial.

    Science.gov (United States)

    Mao, Jun J; Xie, Sharon X; Keefe, John R; Soeller, Irene; Li, Qing S; Amsterdam, Jay D

    2016-12-15

    Generalized Anxiety Disorder (GAD) is one of the most common anxiety disorders treated in primary care, yet current therapies have limited efficacy and substantial side effects. To evaluate long-term chamomile (Matricaria chamomilla L.) use for prevention of GAD symptom relapse. Outpatients from primary care practices and local communities with a primary diagnosis of moderate-to-severe GAD were enrolled for this two-phase study at a large US academic medical center. During Phase 1, eligible participants received 12 weeks of open-label therapy with chamomile pharmaceutical grade extract 1500mg (500mg capsule 3 times daily). During Phase 2, treatment responders were randomized to either 26 weeks of continuation chamomile therapy or placebo in a double-blinded, placebo-substitution design. The primary outcome was time to relapse during continuation therapy, analyzed using Cox proportional hazards. Secondary outcomes included the proportion who relapsed, treatment-emergent adverse events, and vital sign changes. This study is registered at ClinicalTrials.gov, identifier NCT01072344. Between March 1, 2010, and June 30, 2015, we enrolled 179 participants. Of those, 93 (51.9%) were responders and agreed to continue in the double-blind randomized controlled trial. A numerically greater number of placebo-switched (n=12/47; 25.5%) versus chamomile-continuation (n = 7/46; 15.2%) participants relapsed during follow-up. Mean time to relapse was 11.4 ± 8.4 weeks for chamomile and 6.3 ± 3.9 weeks for placebo. Hazard of relapse was non-significantly lower for chamomile (hazard ratio, 0.52; 95% CI, 0.20-1.33; P = 0.16). During follow-up, chamomile participants maintained significantly lower GAD symptoms than placebo (P = 0.0032), with significant reductions in body weight (P = 0.046) and mean arterial blood pressure (P = 0.0063). Both treatments had similar low adverse event rates. Long-term chamomile was safe and significantly reduced moderate

  8. 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

  9. Short- and long-term subjective medical treatment outcome of trauma surgery patients: the importance of physician empathy

    Directory of Open Access Journals (Sweden)

    Steinhausen S

    2014-09-01

    Full Text Available Simone Steinhausen,1 Oliver Ommen,2 Sunya-Lee Antoine,1 Thorsten Koehler,3 Holger Pfaff,4 Edmund Neugebauer11Institute for Research in Operative Medicine (IFOM, Witten/Herdecke University, Campus Cologne-Merheim, Germany; 2Federal Centre for Health Education (BZgA, Cologne, Germany; 3Institute for Applied Social Sciences (infas, Bonn, Germany; 4Institute for Medical Sociology, Health Services Research and Rehabilitation Science (IMVR, Faculty of Human Science and Faculty of Medicine, University of Cologne, Germany Purpose: To investigate accident casualties’ long-term subjective evaluation of treatment outcome 6 weeks and 12 months after discharge and its relation to the experienced surgeon’s empathy during hospital treatment after trauma in consideration of patient-, injury-, and health-related factors. The long-term results are compared to the 6-week follow-up outcomes.Patients and methods: Two hundred and seventeen surgery patients were surveyed at 6 weeks, and 206 patients at 12 months after discharge from the trauma surgical general ward. The subjective evaluation of medical treatment outcome was measured 6 weeks and 12 months after discharge with the respective scale from the Cologne Patient Questionnaire. Physician Empathy was assessed with the Consultation and Relational Empathy Measure. The correlation between physician empathy and control variables with the subjective evaluation of medical treatment outcome 12 months after discharge was identified by means of logistic regression analysis under control of sociodemographic and injury-related factors.Results: One hundred and thirty-six patients were included within the logistic regression analysis at the 12-month follow-up. Compared to the 6-week follow-up, the level of subjective evaluation of medical treatment outcome was slightly lower and the association with physician empathy was weaker. Compared to patients who rated the empathy of their surgeon lower than 31 points, patients

  10. HIGHER EDUCATIONAL INSTITUTION AS A SUBJECT OF ADAPTATION OF RURAL STUDENTS TO THE TERMS OF THE CITY

    Directory of Open Access Journals (Sweden)

    Alyona Aleksandrovna Antipova

    2014-11-01

    Full Text Available The article is devoted to the difficulties of adaptation of rural students to the various spheres of life of the modern city. These difficulties are considered as a field of activity of higher educational institution, acting as the subject of adaptation of students coming to study from rural areas to the terms of the city. The authors ' point of view on this issue is substantiated by the analysis of data of several sociological surveys conducted in various regions of theRussian Federation. Also the experience of assistance in adaptation of the Mordovia state University named after N. P. Ogarev of the city ofSaransk, which is the largest in the Republic of Mordovia University and which accommodates a large number of rural youth. The relevance and scientific novelty of research consists in allocation of areas of adaptation support of students from rural areas by the higher educational institution.

  11. Redox proteomics and physiological responses in Cistus albidus shrubs subjected to long-term summer drought followed by recovery.

    Science.gov (United States)

    Brossa, Ricard; Pintó-Marijuan, Marta; Francisco, Rita; López-Carbonell, Marta; Chaves, Maria Manuela; Alegre, Leonor

    2015-04-01

    The interaction between enzymatic and non-enzymatic antioxidants, endogenous levels of ABA and ABA-GE, the rapid recuperation of photosynthetic proteins under re-watering as well the high level of antioxidant proteins in previously drought-stressed plants under re-watering conditions, will contribute to drought resistance in plants subjected to a long-term drought stress under Mediterranean field conditions. This work provides an overview of the mechanisms of Cistus albidus acclimation to long-term summer drought followed by re-watering in Mediterranean field conditions. To better understand the molecular mechanisms of drought resistance in these plants, a proteomic study using 2-DE and MALDI-TOF/TOF MS/MS was performed on leaves from these shrubs. The analysis identified 57 differentially expressed proteins in water-stressed plants when contrasted to well watered. Water-stressed plants showed an increase, both qualitatively and quantitatively, in HSPs, and downregulation of photosynthesis and carbon metabolism enzymes. Under drought conditions, there was considerable upregulation of enzymes related to redox homeostasis, DHA reductase, Glyoxalase, SOD and isoflavone reductase. However, upregulation of catalase was not observed until after re-watering was carried out. Drought treatment caused an enhancement in antioxidant defense responses that can be modulated by ABA, and its catabolites, ABA-GE, as well as JA. Furthermore, quantification of protein carbonylation was shown to be a useful marker of the relationship between water and oxidative stress, and showed that there was only moderate oxidative stress in C. albidus plants subjected to water stress. After re-watering plants recovered although the levels of ABA-GE and antioxidant enzymes still remain higher than in well-watered plants. We expect that our results will provide new data on summer acclimation to drought stress in Mediterranean shrubs.

  12. The effects of long-term daily folic acid and vitamin B12 supplementation on genome-wide DNA methylation in elderly subjects.

    Science.gov (United States)

    Kok, Dieuwertje E G; Dhonukshe-Rutten, Rosalie A M; Lute, Carolien; Heil, Sandra G; Uitterlinden, André G; van der Velde, Nathalie; van Meurs, Joyce B J; van Schoor, Natasja M; Hooiveld, Guido J E J; de Groot, Lisette C P G M; Kampman, Ellen; Steegenga, Wilma T

    2015-01-01

    Folate and its synthetic form folic acid function as donor of one-carbon units and have been, together with other B-vitamins, implicated in programming of epigenetic processes such as DNA methylation during early development. To what extent regulation of DNA methylation can be altered via B-vitamins later in life, and how this relates to health and disease, is not exactly known. The aim of this study was to identify effects of long-term supplementation with folic acid and vitamin B12 on genome-wide DNA methylation in elderly subjects. This project was part of a randomized, placebo-controlled trial on effects of supplemental intake of folic acid and vitamin B12 on bone fracture incidence (B-vitamins for the PRevention Of Osteoporotic Fractures (B-PROOF) study). Participants with mildly elevated homocysteine levels, aged 65-75 years, were randomly assigned to take 400 μg folic acid and 500 μg vitamin B12 per day or a placebo during an intervention period of 2 years. DNA was isolated from buffy coats, collected before and after intervention, and genome-wide DNA methylation was determined in 87 participants (n = 44 folic acid/vitamin B12, n = 43 placebo) using the Infinium HumanMethylation450 BeadChip. After intervention with folic acid and vitamin B12, 162 (versus 14 in the placebo group) of the 431,312 positions were differentially methylated as compared to baseline. Comparisons of the DNA methylation changes in the participants receiving folic acid and vitamin B12 versus placebo revealed one single differentially methylated position (cg19380919) with a borderline statistical significance. However, based on the analyses of differentially methylated regions (DMRs) consisting of multiple positions, we identified 6 regions that differed statistically significantly between the intervention and placebo group. Pronounced changes were found for regions in the DIRAS3, ARMC8, and NODAL genes, implicated in carcinogenesis and early embryonic development

  13. 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

  14. Long-term effects of daily postprandial physical activity on blood glucose: a randomized controlled trial.

    Science.gov (United States)

    Nygaard, Håvard; Grindaker, Eirik; Rønnestad, Bent Ronny; Holmboe-Ottesen, Gerd; Høstmark, Arne Torbjørn

    2017-04-01

    Previous studies have shown that a bout of moderate or light postprandial physical activity effectively blunts the postprandial increase in blood glucose. The objective of this study was to test whether regular light postprandial physical activity can improve glycemia in persons with hyperglycemia or with a high risk of hyperglycemia. We randomized 56 participants to an intervention or a control group. They were diagnosed as hyperglycemic, not using antidiabetics, or were categorized as high-risk individuals for type 2 diabetes. The intervention group was instructed to undertake a minimum 30 min of daily light physical activity, starting a maximum of 30 min after a meal in addition to their usual physical activity for 12 weeks. The control group maintained their usual lifestyle. Blood samples were taken pre- and post-test. Forty participants completed the study and are included in the results. The self-reported increase in daily physical activity from before to within the study period was higher in the intervention group compared with control (41 ± 25 vs. 2 ± 16 min, p postprandial physical activity improves blood glucose in the long term in persons with hyperglycemia or with high risk of hyperglycemia.

  15. Influence of Random Inclusion of Coconut Fibres on the Short term Strength of Highly Compressible Clay

    Science.gov (United States)

    Ramani Sujatha, Evangelin; SaiSree, S.; Prabalini, C.; Aysha Farsana, Z.

    2017-07-01

    The choice of natural fibres for soil stabilization provides an economic, safe and eco-friendly alternative to improve the properties of soil. They are an important step forward toward sustainable development. An attempt was made to study the influence of the random addition of untreated coconut fibres on the short term strength of soil, its stress-strain behavior, compaction characteristics and index properties. The soil selected for the study is a highly compressible clay sample with a liquid limit of 52.5 % and plasticity index of 38 %. The soil has no organic content. The study reveals that the compaction curves tend to shift to the right side, indicating more plastic behavior with the addition of fibres. The addition of fibres also reorient the soil structure to a more dispersed fashion. A significant increase in the unconfined compressive strength is also observed. An increase of nearly 51 % in the unconfined compressive strength is observed at 0.75 % coir inclusion. The stress-strain behavior of the soil shows a shift toward more plastic behavior. The mode of failure of the soil specimen is by cracking and with fibre inclusion, length of the failure cracks is restrained as the fibre tends to hold the cracks together, resulting in shorter cracks, with significant bulging of the specimen at failure.

  16. The effects of short-term alpha-ketoisocaproic acid supplementation on exercise performance: a randomized controlled trial

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    Yarrow Joshua F

    2007-07-01

    Full Text Available Abstract Background This study examined the efficacy of short-term alpha-ketoisocaproic acid (KIC monotherapy supplementation immediately prior to moderate- and high-intensity single bout exercise performance. Methods Thirteen resistance trained men (22.8 ± 2.5 years; 81.6 ± 12.6 kg participated in a prospective, randomized, double blind, placebo controlled crossover experiment. Each subject completed one familiarization and four experimental trials with either 1.5 g or 9.0 g of either KIC or isocaloric placebo control (CONT, following an overnight fast. During the experimental trials, subjects consumed the supplement regimen and then completed leg and chest press repetitions to failure and 30 s of repeated maximal vertical jumping (VJ on a force plate. Results In this treatment regimen, no significant differences (p > 0.05 were observed between dosages or conditions for leg press (low CONT = 19.8 ± 0.4 SEM, low KIC = 21.0 ± 0.5, high CONT = 20.1 ± 0.3, high KIC = 22.4 ± 0.6 or chest press (low CONT = 18.1 ± 0.2, low KIC = 18.5 ± 0.3, high CONT = 17.8 ± 0.3, high KIC = 18.0 ± 0.3 repetitions to failure. Additionally, no significant differences were observed for peak or mean VJ performance (low CONT = 34.6 ± 2.2 cm and 28.6 ± 1.8 cm; low KIC = 35.6 ± 2.0 cm and 29.4 ± 1.6 cm; high CONT = 35.7 ± 2.1 cm and 29.4 ± 1.7 cm; high KIC = 34.8 ± 2.3 cm and 28.3 ± 1.7 cm, respectively. Conclusion Based on our results, we conclude that acute KIC ingestion by itself with no other ergogenic supplement, immediately prior to exercise, did not alter moderate- nor high-intensity single-bout exercise performance in young resistance-trained males. This study addressed single-dose single-bout performance events; the efficacy of KIC monotherapy supplementation on repeated high-intensity exercise bouts and long-term exercise training remains unknown.

  17. 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

  18. 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

  19. Life satisfaction in subjects with long-term musculoskeletal pain in relation to pain intensity, pain distribution and coping.

    Science.gov (United States)

    Anke, Audny; Damsgård, Elin; Røe, Cecilie

    2013-03-01

    To investigate levels of life satisfaction in subjects with long-term musculoskeletal pain in relation to pain characteristics and coping. Cross-sectional study. A total of 232 (42%) respondents answered self--report questionnaires regarding life satisfaction, self-efficacy, sense of coherence, pain distribution and pain intensity at rest and during activity. Levels of life satisfaction and scores for sense of coherence were low. Pain intensity at rest was negatively correlated with global life satisfaction. This result was also obtained in multiple regression analyses together with the coping factors. The life satisfaction domains activities of daily living/contacts were negatively correlated with pain intensity during activity, and the domains work/economy were negatively correlated with pain distribution. Pain was not associated with satisfaction with family life, partner relationship or sexual life. Younger age, being married/cohabitant and being female were protective for some domains. Clinically meaningful subgroups with regard to adaptation were identified by cluster analysis, and the highest level of coping was found in the adaptive cluster with high life satisfaction/low pain intensity at rest. Long-term pain is related to low levels of life satisfaction, and pain intensity and distribution influence satisfaction in different domains. Pain intensity is negatively associated with coping. The results support efforts to reduce pain, together with strengthening active coping processes and addressing individual needs.

  20. 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.

  1. 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.

  2. Tissue Effects in a Randomized Controlled Trial of Short-term Finasteride in Early Prostate Cancer.

    Science.gov (United States)

    Kim, Jeri; Davis, John W; Klein, Eric A; Magi-Galluzzi, Cristina; Lotan, Yair; Ward, John F; Pisters, Louis L; Basler, Joseph W; Pettaway, Curtis A; Stephenson, Andrew; Li Ning Tapia, Elsa M; Efstathiou, Eleni; Wang, Xuemei; Do, Kim-Anh; Lee, J Jack; Gorlov, Ivan P; Vornik, Lana A; Hoque, Ashraful M; Prokhorova, Ina N; Parnes, Howard L; Lippman, Scott M; Thompson, Ian M; Brown, Powel H; Logothetis, Christopher J; Troncoso, Patricia

    2016-05-01

    In the Prostate Cancer Prevention Trial, finasteride selectively suppressed low-grade prostate cancer and significantly reduced the incidence of prostate cancer in men treated with finasteride compared with placebo. However, an apparent increase in high-grade disease was also observed among men randomized to finasteride. We aimed to determine why and hypothesized that there is a grade-dependent response to finasteride. From 2007 to 2012, we randomized dynamically by intranet-accessible software 183 men with localized prostate cancer to receive 5mg finasteride or placebo daily in a double-blind study during the 4-6weeks preceding prostatectomy. As the primary end point, the expression of a predefined molecular signature (ERβ, UBE2C, SRD5A2, and VEGF) differentiating high- and low-grade tumors in Gleason grade (GG) 3 areas of finasteride-exposed tumors from those in GG3 areas of placebo-exposed tumors, adjusted for Gleason score (GS) at prostatectomy, was compared. We also determined androgen receptor (AR) levels, Ki-67, and cleaved caspase 3 to evaluate the effects of finasteride on the expression of its downstream target, cell proliferation, and apoptosis, respectively. The expression of these markers was also compared across grades between and within treatment groups. Logistic regression was used to assess the expression of markers. We found that the predetermined molecular signature did not distinguish GG3 from GG4 areas in the placebo group. However, AR expression was significantly lower in the GG4 areas of the finasteride group than in those of the placebo group. Within the finasteride group, AR expression was also lower in GG4 than in GG3 areas, but not significantly. Expression of cleaved caspase 3 was significantly increased in both GG3 and GG4 areas in the finasteride group compared to the placebo group, although it was lower in GG4 than in GG3 areas in both groups. We showed that finasteride's effect on apoptosis and AR expression is tumor grade dependent

  3. 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

  4. Randomized controlled trial evaluating the temporal effects of high-intensity exercise on learning, short-term and long-term memory, and prospective memory.

    Science.gov (United States)

    Frith, Emily; Sng, Eveleen; Loprinzi, Paul D

    2017-11-01

    The broader purpose of this study was to examine the temporal effects of high-intensity exercise on learning, short-term and long-term retrospective memory and prospective memory. Among a sample of 88 young adult participants, 22 were randomized into one of four different groups: exercise before learning, control group, exercise during learning, and exercise after learning. The retrospective assessments (learning, short-term and long-term memory) were assessed using the Rey Auditory Verbal Learning Test. Long-term memory including a 20-min and 24-hr follow-up assessment. Prospective memory was assessed using a time-based procedure by having participants contact (via phone) the researchers at a follow-up time period. The exercise stimulus included a 15-min bout of progressive maximal exertion treadmill exercise. High-intensity exercise prior to memory encoding (vs. exercise during memory encoding or consolidation) was effective in enhancing long-term memory (for both 20-min and 24-h follow-up assessments). We did not observe a differential temporal effect of high-intensity exercise on short-term memory (immediate post-memory encoding), learning or prospective memory. The timing of high-intensity exercise may play an important role in facilitating long-term memory. © 2017 Federation of European Neuroscience Societies and John Wiley & Sons Ltd.

  5. Acceptance and Commitment Therapy for Depression: A Preliminary Randomized Clinical Trial for Unemployed on Long-Term Sick Leave

    Science.gov (United States)

    Folke, Fredrik; Parling, Thomas; Melin, Lennart

    2012-01-01

    This preliminary study investigated the feasibility of a brief Acceptance and Commitment Therapy (ACT) in a Swedish sample of unemployed individuals on long-term sick leave due to depression. Participants were randomized to a nonstandardized control condition (N = 16) or to the ACT condition (N = 18) consisting of 1 individual and 5 group…

  6. Long-term sequential deferiprone-deferoxamine versus deferiprone alone for thalassaemia major patients: a randomized clinical trial

    DEFF Research Database (Denmark)

    Maggio, Aurelio; Vitrano, Angela; Capra, Marcello

    2009-01-01

    A multicentre randomized open-label trial was designed to assess the effectiveness of long-term sequential deferiprone-deferoxamine (DFO-DFP) versus DFP alone to treat thalassaemia major (TM). DFP at 75 mg/kg, divided into three oral daily doses, for 4 d/week and DFO by subcutaneous infusion (8-1...

  7. Long-term effects of a weight loss intervention with or without exercise component in postmenopausal women : A randomized trial

    NARCIS (Netherlands)

    de Roon, Martijn; van Gemert, Willemijn A; Peeters, Petra H M; Schuit, Albertine J; Monninkhof, Evelyn M.

    The aim of this study was to determine the long-term effects of a weight loss intervention with or without an exercise component on body weight and physical activity. Women were randomized to diet (n = 97) or exercise (N = 98) for 16 weeks. During the intervention, both groups had achieved the set

  8. Long-term effects of a weight loss intervention with or without exercise component in postmenopausal women : A randomized trial

    NARCIS (Netherlands)

    de Roon, Martijn; van Gemert, Willemijn A.; Peeters, Petra H.; Schuit, Albertine J.; Monninkhof, Evelyn M.

    2017-01-01

    The aim of this study was to determine the long-term effects of a weight loss intervention with or without an exercise component on body weight and physical activity. Women were randomized to diet (n = 97) or exercise (N = 98) for 16 weeks. During the intervention, both groups had achieved the set

  9. Long-term effectiveness of computer-generated tailored patient education on benzodiazepines : a randomized controlled trial

    NARCIS (Netherlands)

    Ten Wolde, Geeske Brecht; Dijkstra, Arie; Van Empelen, Pepijn; van den Hout, Wilbert; Neven, Arie Knuistingh; Zitman, Frans

    Aims Chronic benzodiazepine use is highly prevalent and is associated with a variety of negative health consequences. The present study examined the long-term effectiveness of a tailored patient education intervention on benzodiazepine use. Participants A randomized controlled trial was conducted

  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. The short term effect of kettlebell swings on lumbopelvic pressure pain thresholds: a randomized controlled trial.

    Science.gov (United States)

    Keilman, Brandon M; Hanney, William J; Kolber, Morey J; Pabian, Patrick S; Salamh, Paul A; Rothschild, Carey E; Liu, Xinliang

    2016-11-19

    The purpose of this study was to investigate the short-term effect of kettlebell swings (KBSs) on lumbopelvic pressure pain thresholds (PPTs) in healthy adults. Sixty participants (male=23, female=37, mean age=25.12 years ±2.86, height=170.73 cm ± 9.2, mass=70.49 kg ± 13.32) were randomized into one of two groups. The experimental group performed a warm-up followed by eight consecutive 20-second rounds of KBS with 10-second rest periods. The control group performed the warm-up alone. An evaluator blinded to group assignment, assessed PPTs immediately before and after the intervention using a handheld pressure algometer. The algometer was applied to the regions of the right paravertebral (PVM), quadratus lumborum (QL), and piriformis (PF) muscles perpendicular to the skin based on standardized palpation procedures. The participants were instructed to report when sensation changed from "comfortable pressure" to "slightly unpleasant pain." No significant between group differences existed at baseline for PPTs (PVM p=.068; QL p = .134, & PF p=.105). Significant group by time interactions existed for each site following the interventions (PVM, p=.018; QL, p=.004; PF, p=.026) favoring the KBS group. Results suggest that KBSs create a reduction in muscle sensitivity to noxious pressure based on pressure algometry measurements. These findings may be due to the unique cyclic muscle contraction associated with KBSs, which has been proposed to facilitate removal of muscle metabolites. The findings of this study provide a foundation for future studies to examine the use of this type of training in patients with low back pain of a muscular etiology or post-exercise muscle soreness. Furthermore, future studies should evaluate specific mechanisms for these effects.

  12. Long-Term Improvements After Multimodal Rehabilitation in Late Phase After Stroke: A Randomized Controlled Trial.

    Science.gov (United States)

    Bunketorp-Käll, Lina; Lundgren-Nilsson, Åsa; Samuelsson, Hans; Pekny, Tulen; Blomvé, Karin; Pekna, Marcela; Pekny, Milos; Blomstrand, Christian; Nilsson, Michael

    2017-07-01

    Treatments that improve function in late phase after stroke are urgently needed. We assessed whether multimodal interventions based on rhythm-and-music therapy or horse-riding therapy could lead to increased perceived recovery and functional improvement in a mixed population of individuals in late phase after stroke. Participants were assigned to rhythm-and-music therapy, horse-riding therapy, or control using concealed randomization, stratified with respect to sex and stroke laterality. Therapy was given twice a week for 12 weeks. The primary outcome was change in participants' perception of stroke recovery as assessed by the Stroke Impact Scale with an intention-to-treat analysis. Secondary objective outcome measures were changes in balance, gait, grip strength, and cognition. Blinded assessments were performed at baseline, postintervention, and at 3- and 6-month follow-up. One hundred twenty-three participants were assigned to rhythm-and-music therapy (n=41), horse-riding therapy (n=41), or control (n=41). Post-intervention, the perception of stroke recovery (mean change from baseline on a scale ranging from 1 to 100) was higher among rhythm-and-music therapy (5.2 [95% confidence interval, 0.79-9.61]) and horse-riding therapy participants (9.8 [95% confidence interval, 6.00-13.66]), compared with controls (-0.5 [-3.20 to 2.28]); P =0.001 (1-way ANOVA). The improvements were sustained in both intervention groups 6 months later, and corresponding gains were observed for the secondary outcomes. Multimodal interventions can improve long-term perception of recovery, as well as balance, gait, grip strength, and working memory in a mixed population of individuals in late phase after stroke. URL: http//www.ClinicalTrials.gov. Unique identifier: NCT01372059. © 2017 American Heart Association, Inc.

  13. Long-term effectiveness of a nutritional program in reducing early childhood caries: a randomized trial.

    Science.gov (United States)

    Feldens, Carlos Alberto; Giugliani, Elsa Regina Justo; Duncan, Bruce Bartholow; Drachler, Maria de Lourdes; Vítolo, Márcia Regina

    2010-08-01

    To investigate the effectiveness of home visits advising mothers about healthy feeding practices during the first year of life on the occurrence of early childhood caries and severe early childhood caries at 4 years of age. We conducted a parallel randomized trial of mothers of single, full-term children with birthweight > or = 2500g in São Leopoldo, Brazil. The intervention group received monthly advice up to 6 months and then at 8, 10 and 12 months by undergraduate nutrition students, based on the "Ten Steps for Healthy Feeding'', a Brazilian national health policy for primary care based on World Health Organization guidelines. The primary outcome was the occurrence of early childhood caries at age four. Secondary outcomes included the occurrence of severe early childhood caries and the number of affected teeth: decayed (white spots and cavities), missing and filled teeth (d(1+)mft). Blinded observers ascertained feeding habits in the home and one blinded dentist performed dental examinations in a municipal clinic. This study is registered with ClinicalTrials.gov, number NCT00629629. Of 500 mother-child pairs (200 intervention, 300 control) enrolled, 340 (141 intervention, 199 control) completed 4 year follow-up. As 138 (69.3%) controls but only 76 (53.9%) intervention children had early childhood caries, home counseling reduced incidence by 22% (RR 0.78; 95% CI 0.65-0.93). Severe early childhood caries incidence was reduced by 32% (RR 0.68; 95% CI 050-0.92). The mean number of affected teeth was lower for the intervention group (3.25) compared with the control group (4.15) (Mann Whitney U-test; p=0.023). No adverse effects were noted. Home nutritional advice during the first year of life decreases caries incidence and severity at four years of age in a low income community.

  14. 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.

  15. Brief Report: Conveying Subjective Experience in Conversation: Production of Mental State Terms and Personal Narratives in Individuals with High Functioning Autism

    Science.gov (United States)

    Bang, Janet; Burns, Jesse; Nadig, Aparna

    2013-01-01

    Mental state terms and personal narratives are conversational devices used to communicate subjective experience in conversation. Pre-adolescents with high-functioning autism (HFA, n = 20) were compared with language-matched typically-developing peers (TYP, n = 17) on production of mental state terms (i.e., perception, physiology, desire, emotion,…

  16. 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.

  17. 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...

  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. 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.

  20. Cadmium concentrations in the testes, sperm, and spermatids of mice subjected to long-term cadmium chloride exposure.

    Science.gov (United States)

    Bench, G; Corzett, M H; Martinelli, R; Balhorn, R

    1999-01-01

    Exposures to cadmium have been reported to reduce male fertility and there are several hypotheses that suggest how reduced male fertility may result from incorporation of cadmium into sperm chromatin. The purpose of this study was to determine whether mice subjected to long-term intraperitoneal cadmium exposure incorporated cadmium into their sperm chromatin. Male mice were exposed to 0.1 mg/kg body weight cadmium in the form of CdCl2 via intraperitoneal injection once per week for 4, 10, 26, and 52 weeks and then sacrificed. The cadmium contents of the liver, testes, pooled sperm, and pooled spermatids from dosed and control animals were determined by atomic absorption spectroscopy. Cadmium and zinc contents in individual sperm and spermatid heads were determined by particle-induced x-ray emission. Atomic absorption spectroscopy revealed that although cadmium accumulated in the liver and testes, cadmium was not detected in pooled sperm or spermatid samples down to minimum detectable limits of 0.02 microg/g dry weight. Particle-induced x-ray emission analyses did not show the presence of cadmium in any sperm or spermatid head down to minimum detectable limits of 15 microg/g dry weight. Particle-induced x-ray emission analyses also demonstrated that phosphorus, sulfur, and zinc concentrations in individual sperm and spermatid heads were not altered by exposure to CdCl2. Because cadmium was not incorporated into sperm chromatin at levels above 0.02 microg/g dry weight, the data cast doubt on hypotheses that suggest that reduced male fertility may result from incorporation of cadmium into sperm chromatin.

  1. Long-term subjective benefit with a bone conduction implant sound processor in 44 patients with single-sided deafness.

    Science.gov (United States)

    Desmet, Jolien; Wouters, Kristien; De Bodt, Marc; Van de Heyning, Paul

    2014-07-01

    Studies that investigate the subjective benefit from a bone conduction implant (BCI) sound processor in patients with single-sided sensorineural deafness (SSD) have been limited to examining short- and mid-term benefit. In the current study, we performed a survey among 44 SSD BCI users with a median follow-up time of 50 months. Forty-four experienced SSD BCI users participated in the survey, which consisted of the Abbreviated Profile of Hearing Aid Benefit, the Single-Sided Deafness Questionnaire, the Short Hearing Handicap Inventory for Adults, and a self-made user questionnaire. For patients with tinnitus, the Tinnitus Questionnaire was also completed. The results of the survey were correlated with contralateral hearing loss, age at implantation, duration of the hearing loss at the time of implantation, duration of BCI use, and the presence and burden of tinnitus. In total, 86% of the patients still used their sound processor. The Abbreviated Profile of Hearing Aid Benefit and the Short Hearing Handicap Inventory for Adults show a statistically significant overall improvement with the BCI. The Single-Sided Deafness Questionnaire and the user questionnaire showed that almost 40% of the patients reported daily use of the sound processor. However, the survey of daily use reveals benefit only in certain circumstances. Speech understanding in noisy situations is rated rather low, and 58% of all patients reported that their BCI benefit was less than expected. The majority of the patients reported an overall improvement from using their BCI. However, the number of users decreases during a longer follow-up time and patients get less enthusiastic about the device after an extended period of use, especially in noisy situations. However, diminished satisfaction because of time-related reductions in processor function could not be ruled out.

  2. Proof-of-concept, randomized, controlled clinical trial of Bacillus-Calmette-Guerin for treatment of long-term type 1 diabetes.

    Directory of Open Access Journals (Sweden)

    Denise L Faustman

    Full Text Available No targeted immunotherapies reverse type 1 diabetes in humans. However, in a rodent model of type 1 diabetes, Bacillus Calmette-Guerin (BCG reverses disease by restoring insulin secretion. Specifically, it stimulates innate immunity by inducing the host to produce tumor necrosis factor (TNF, which, in turn, kills disease-causing autoimmune cells and restores pancreatic beta-cell function through regeneration.Translating these findings to humans, we administered BCG, a generic vaccine, in a proof-of-principle, double-blind, placebo-controlled trial of adults with long-term type 1 diabetes (mean: 15.3 years at one clinical center in North America. Six subjects were randomly assigned to BCG or placebo and compared to self, healthy paired controls (n = 6 or reference subjects with (n = 57 or without (n = 16 type 1 diabetes, depending upon the outcome measure. We monitored weekly blood samples for 20 weeks for insulin-autoreactive T cells, regulatory T cells (Tregs, glutamic acid decarboxylase (GAD and other autoantibodies, and C-peptide, a marker of insulin secretion. BCG-treated patients and one placebo-treated patient who, after enrollment, unexpectedly developed acute Epstein-Barr virus infection, a known TNF inducer, exclusively showed increases in dead insulin-autoreactive T cells and induction of Tregs. C-peptide levels (pmol/L significantly rose transiently in two BCG-treated subjects (means: 3.49 pmol/L [95% CI 2.95-3.8], 2.57 [95% CI 1.65-3.49] and the EBV-infected subject (3.16 [95% CI 2.54-3.69] vs.1.65 [95% CI 1.55-3.2] in reference diabetic subjects. BCG-treated subjects each had more than 50% of their C-peptide values above the 95(th percentile of the reference subjects. The EBV-infected subject had 18% of C-peptide values above this level.We conclude that BCG treatment or EBV infection transiently modified the autoimmunity that underlies type 1 diabetes by stimulating the host innate immune response. This suggests that BCG or other

  3. Long-term Diet and Biomarker Changes after a Short-term Intervention among Hispanic Breast Cancer Survivors: The ¡Cocinar Para Su Salud! Randomized Controlled Trial.

    Science.gov (United States)

    Greenlee, Heather; Ogden Gaffney, Ann; Aycinena, A Corina; Koch, Pam; Contento, Isobel; Karmally, Wahida; Richardson, John M; Shi, Zaixing; Lim, Emerson; Tsai, Wei-Yann; Santella, Regina M; Blaner, William S; Clugston, Robin D; Cremers, Serge; Pollak, Susan; Sirosh, Iryna; Crew, Katherine D; Maurer, Matthew; Kalinsky, Kevin; Hershman, Dawn L

    2016-11-01

    Among Hispanic breast cancer survivors, we examined the long-term effects of a short-term culturally based dietary intervention on increasing fruits/vegetables (F/V), decreasing fat, and changing biomarkers associated with breast cancer recurrence risk. Spanish-speaking women (n = 70) with a history of stage 0-III breast cancer who completed treatment were randomized to ¡Cocinar Para Su Salud! (n = 34), a culturally based 9-session program (24 hours over 12 weeks, including nutrition education, cooking classes, and food-shopping field trips), or a control group (n = 36, written dietary recommendations for breast cancer survivors). Diet recalls, fasting blood, and anthropometric measures were collected at baseline, 6, and 12 months. We report changes between groups at 12 months in dietary intake and biomarkers using 2-sample Wilcoxon t tests and generalized estimating equation (GEE) models. At 12 months, the intervention group compared with the control group reported higher increases in mean daily F/V servings (total: +2.0 vs. -0.4; P Salud! program was effective at increasing long-term F/V intake in Hispanic breast cancer survivors and changed biomarkers associated with breast cancer recurrence risk. It is possible for short-term behavioral interventions to have long-term effects on behaviors and biomarkers in minority cancer patient populations. Results can inform future study designs. Cancer Epidemiol Biomarkers Prev; 25(11); 1491-502. ©2016 AACR. ©2016 American Association for Cancer Research.

  4. Long-term effects of the Mediterranean lifestyle program: a randomized clinical trial for postmenopausal women with type 2 diabetes

    OpenAIRE

    Toobert, Deborah J; Glasgow, Russell E; Strycker, Lisa A; Barrera, Manuel; Ritzwoller, Debra P; Weidner, Gerdi

    2007-01-01

    Abstract Background Multiple-risk-factor interventions offer a promising means for addressing the complex interactions between lifestyle behaviors, psychosocial factors, and the social environment. This report examines the long-term effects of a multiple-risk-factor intervention. Methods Postmenopausal women (N = 279) with type 2 diabetes participated in the Mediterranean Lifestyle Program (MLP), a randomized, comprehensive lifestyle intervention study. The intervention targeted healthful eat...

  5. 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 ...

  6. 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....

  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. 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

  9. 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.

  10. Importance to include the term superficial musculoaponeurotic system in medical subject headings and in the international anatomical nomenclature.

    Science.gov (United States)

    Ferreira, Lydia Massako; Locali, Rafael Fagionato; Lapin, Guilherme Abbud Franco; Hochman, Bernardo

    2011-06-01

    To investigate the relevance of the term superficial musculoaponeurotic system (SMAS) and demonstrate that this term is important enough to be added to the MeSH database and listed in International Anatomical Nomenclature. Terms related to SMAS were selected from original articles retrieved from the ISI Web of Science and MEDLINE (PubMed) databases. Groups of terms were created to define a search strategy with high-sensitivity and restricted to scientific periodicals devoted to plastic surgery. This study included articles between January 1996 and May 2009, whose titles, abstracts, and keywords were searched for SMAS-related terms and all occurrences were recorded. A total of 126 original articles were retrieved from the main periodicals related to plastic surgery in the referred databases. Of these articles, 51.6% had SMAS-related terms in the abstract only, and 25.4% had SMAS-related terms in both the title and abstract. The term 'superficial musculoaponeurotic system' was present as a keyword in 19.8% of the articles. The most frequent terms were 'SMAS' (71.4%) and superficial musculoaponeurotic system (62.7%). The term SMAS refers to a structure relevant enough to start a discussion about indexing it as a keyword and as an official term in Terminologia Anatomica: International Anatomical Terminology.

  11. Management of prelabor rupture of membranes at term. A randomized study

    DEFF Research Database (Denmark)

    Sperling, Lene; Schantz, A L; Wåhlin, A

    1993-01-01

    women with singleton pregnancies, cephalic presentations, gestational age of 36 completed weeks or more were allocated at random to induction with oxytocin either 6 hours after PROM (n = 62) (early) or 24 hours (n = 62) (late). Those eligible, but not participating in the study, totalled 238 women. MAIN...

  12. Inhomogeneous Linear Random Differential Equations with Mutual Correlations between Multiplicative, Additive and Initial-Value Terms

    NARCIS (Netherlands)

    Roerdink, J.B.T.M.

    1981-01-01

    The cumulant expansion for linear stochastic differential equations is extended to the general case in which the coefficient matrix, the inhomogeneous part and the initial condition are all random and, moreover, statistically interdependent. The expansion now involves not only the autocorrelation

  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. Comparison between the effects of trigger point mesotherapy versus acupuncture points mesotherapy in the treatment of chronic low back pain: a short term randomized controlled trial.

    Science.gov (United States)

    Di Cesare, Annalisa; Giombini, Arrigo; Di Cesare, Mariachiara; Ripani, Maurizio; Vulpiani, Maria Chiara; Saraceni, Vincenzo Maria

    2011-02-01

    The goal of this study was to compare the effects of trigger point (TRP) mesotherapy and acupuncture (ACP) mesotherapy in the treatment of patients with chronic low back pain. Short term randomized controlled trial. 62 subjects with chronic low back pain were recruited at outpatients Physical Medicine and Rehabilitation Clinic at the University of Rome "La Sapienza" in the period between July 2006 and May 2008. Study subjects were assigned to receive 4 weeks treatments with either trigger point mesotherapy (TRP mesotherapy, n=29) or acupoints mesotherapy (ACP mesotherapy, n=33). Pain intensity with a pain visual analogic scale (VAS) and verbal rating scale (VRS) and pain disability with McGill Pain Questionnaire Short Form (SFMPQ), Roland Morris Disability Questionnaire (RMQ) and Oswestry Low Back Pain Disability Questionaire (ODQ). ACP mesotherapy shows a more effective results in VRS and VAS measures in the follow-up (p(VRS)=mesotherapy group. Our results suggest that the response to ACP mesotherapy may be greater than the response to TRP mesotherapy in the short term follow-up. This technique could be nevertheless a viable option as an adjunct treatment in an overall treatment planning of CLBP. Copyright © 2010 Elsevier Ltd. All rights reserved.

  15. 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

  16. 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...

  17. 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

  18. Short-term and long-term effects of a psycho-educational group intervention for family caregivers in palliative home care - results from a randomized control trial.

    Science.gov (United States)

    Holm, Maja; Årestedt, Kristofer; Carlander, Ida; Fürst, Carl-Johan; Wengström, Yvonne; Öhlen, Joakim; Alvariza, Anette

    2016-07-01

    Family caregivers in cancer and palliative care often face heavy responsibilities and feel insufficiently prepared for the situation as caregivers. This study evaluates short-term and long-term effects of a psycho-educational group intervention aiming to increase preparedness for family caregiving in specialized palliative home care. The study design was a randomized control trial where family caregivers were allocated either to an intervention or control group. The intervention was delivered as a program including three sessions by health professionals (physician, nurse, and social worker/priest). Family caregivers from 10 specialized palliative home care settings were included. Questionnaires with validated instruments at baseline, upon completion, and 2 months following the intervention were used to measure effects of the intervention. The primary outcome was preparedness for caregiving in family caregivers. In total, 21 intervention programs were delivered, and 119 family caregivers completed all three measurements. The intervention group had significantly increased their preparedness for caregiving in both the short-term and long-term follow-up compared with the control group. The intervention group also reported significantly increased competence for caregiving in short-term but not long. No effects of the intervention were found on rewards for caregiving, caregiver burden, health, anxiety, or depression. The psycho-educational intervention has the potential to be used by health professionals to improve preparedness for caregiving among family caregivers in palliative care both in short and long terms. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  19. 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.

  20. Effects of neurofeedback on the short-term memory and continuous attention of patients with moderate traumatic brain injury: A preliminary randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Reza Rostami

    2017-10-01

    Full Text Available Purpose: There are some studies which showed neurofeedback therapy (NFT can be effective in clients with traumatic brain injury (TBI history. However, randomized controlled clinical trials are still needed for evaluation of this treatment as a standard option. This preliminary study was aimed to evaluate the effect of NFT on continuous attention (CA and short-term memory (STM of clients with moderate TBI using a randomized controlled clinical trial (RCT. Methods: In this preliminary RCT, seventeen eligible patients with moderate TBI were randomly allocated in two intervention and control groups. All the patients were evaluated for CA and STM using the visual continuous attention test and Wechsler memory scale-4th edition (WMS-IV test, respectively, both at the time of inclusion to the project and four weeks later. The intervention group participated in 20 sessions of NFT through the first four weeks. Conversely, the control group participated in the same NF sessions from the fifth week to eighth week of the project. Results: Eight subjects in the intervention group and five subjects in the control group completed the study. The mean and standard deviation of participants' age were (26.75 ± 15.16 years and (27.60 ± 8.17 years in experiment and control groups, respectively. All of the subjects were male. No significant improvement was observed in any variables of the visual continuous attention test and WMS-IV test between two groups (p ≥ 0.05. Conclusion: Based on our literature review, it seems that our study is the only study performed on the effect of NFT on TBI patients with control group. NFT has no effect on CA and STM in patients with moderate TBI. More RCTs with large sample sizes, more sessions of treatment, longer time of follow-up and different protocols are recommended. Keywords: Neurofeedback, Brain injuries, Attention, Short-term memory

  1. 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...

  2. 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...

  3. The effects of long- and short-term interdisciplinary treatment approaches in women with fibromyalgia: a randomized controlled trial.

    Science.gov (United States)

    Saral, Ilknur; Sindel, Dilsad; Esmaeilzadeh, Sina; Sertel-Berk, Hanife Ozlem; Oral, Aydan

    2016-10-01

    We investigated the effects of long- and short-term interdisciplinary treatment approaches for reducing symptoms and improving health-related quality of life (HRQoL) and physical functions of patients with fibromyalgia and compared the effects of two different interdisciplinary treatment approaches. We conducted a prospective, randomized, controlled trial involving 66 women with fibromyalgia eligible for the study at a university hospital setting. The patients were randomized into three groups (allocation ratio 1:1:1) using a computer-generated random numbers: a long-term interdisciplinary treatment group (LG, n = 22) that participated in 10 sessions (3-h once-weekly session for 10 weeks) of cognitive behavioral therapy (CBT) together with exercise training and other fibromyalgia related educational programs (two full days); a short-term interdisciplinary treatment group (SG, n = 22) that received two full days of educational, exercise, and CBT programs; and a control group (CG, n = 22). The patients were evaluated at baseline and 6 months after treatment using the visual analog scale (pain, fatigue, and sleep), Fibromyalgia Impact Questionnaire, Beck Depression Inventory, Short Form-36, tender point numbers, and pressure algometry as primary outcomes. The statistical analysis was confined to the 'per-protocol' set. No blinding was performed. The number of patients analyzed was 21 in the LG, 19 in the SG, and 19 in the CG. The intensity of pain (p treatment approaches when compared with controls; the long-term treatment was found more effective in reducing pain than the short-term. Both, long- and short-term interdisciplinary treatments were effective in reducing the severity of some symptoms and disease activity in patients with fibromyalgia. The short-term program well meets the needs of women with fibromyalgia particularly in relation to pain and health status as measured using FIQ; however, a long-term program may be beneficial in reducing fatigue and

  4. Radiation Therapy Did Not Induce Long-Term Changes in Rectal Mucosa: Results From the Randomized Scandinavian Prostate Cancer Group 7 Trial

    Energy Technology Data Exchange (ETDEWEB)

    Slagsvold, Jens Erik, E-mail: Jens.Erik.Slagsvold@stolav.no [Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); Viset, Trond [Department of Pathology, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); Wibe, Arne [Institute of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim (Norway); Department of Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); Kaasa, Stein [Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); European Palliative Care Research Center, Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim (Norway); Widmark, Anders [Department of Radiation Sciences, Cancercentrum, Umeå (Sweden); Lund, Jo-Åsmund [Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); European Palliative Care Research Center, Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim (Norway)

    2016-07-15

    Purpose: To investigate long-term changes in the rectal mucosa after curative external beam radiation therapy in the treatment of prostate cancer. Methods and Materials: In the Scandinavian Prostate Cancer Group 7 trial, 880 men with locally advanced prostate cancer were randomized to hormonal therapy alone versus hormonal therapy plus radiation therapy to 70 Gy. A subcohort from this trial being randomized at our center (n=178) was invited to a study on late anorectal side effects during 2003-2005, approximately 5 years after treatment, including measuring health-reported quality of life and physician-assessed toxicity score by the Late Effects Normal Tissue Task Force/Subjective, Objective, Management, Analytic (LENT/SOMA) and European Organization for Research and Treatment of Cancer/Radiation Therapy Oncology Group score. Sixty-seven patients had a rectal mucosa biopsy. Sixty-four biopsies were included in the final analysis, of which 33 patients were randomized to hormonal treatment and 31 to hormonal treatment plus radiation therapy. The presence of fibrosis, number of capillaries, and lymphocyte infiltration was then evaluated by light microscopy. Results: The group receiving radiation therapy had significantly higher LENT/SOMA and function/bother scale scores than the group that only received hormonal treatment, but there was no significant difference in the presence of fibrosis, ectasia, number of capillaries in the lamina propria, or lymphocyte infiltration between the groups. Conclusion: Radiation therapy to 70 Gy to the prostate does not induce long-term microscopic mucosal changes in the rectum 5 years after treatment. This is in contrast to the general assumption that structural changes, including fibrosis, seen after radiation therapy include the mucosa. We speculate that the main late effects of radiation therapy on the structure of the rectum are located in the deeper layers of the rectal wall than the mucosa.

  5. Long-term tolerability of telcagepant for acute treatment of migraine in a randomized trial

    DEFF Research Database (Denmark)

    Connor, Kathryn M; Aurora, Sheena K; Loeys, Tom

    2011-01-01

    To evaluate the long-term tolerability of telcagepant for acute treatment of intermittent migraine attacks. Background.- Telcagepant is a calcitonin gene-related peptide (CGRP) receptor antagonist being investigated for the acute treatment of migraine....

  6. 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

  7. Long-term tolerability of telcagepant for acute treatment of migraine in a randomized trial

    DEFF Research Database (Denmark)

    Connor, Kathryn M; Aurora, Sheena K; Loeys, Tom

    2011-01-01

    To evaluate the long-term tolerability of telcagepant for acute treatment of intermittent migraine attacks. Background.- Telcagepant is a calcitonin gene-related peptide (CGRP) receptor antagonist being investigated for the acute treatment of migraine.......To evaluate the long-term tolerability of telcagepant for acute treatment of intermittent migraine attacks. Background.- Telcagepant is a calcitonin gene-related peptide (CGRP) receptor antagonist being investigated for the acute treatment of migraine....

  8. Characterisation of random Gaussian and non-Gaussian stress processes in terms of extreme responses

    Directory of Open Access Journals (Sweden)

    Colin Bruno

    2015-01-01

    Full Text Available In the field of military land vehicles, random vibration processes generated by all-terrain wheeled vehicles in motion are not classical stochastic processes with a stationary and Gaussian nature. Non-stationarity of processes induced by the variability of the vehicle speed does not form a major difficulty because the designer can have good control over the vehicle speed by characterising the histogram of instantaneous speed of the vehicle during an operational situation. Beyond this non-stationarity problem, the hard point clearly lies in the fact that the random processes are not Gaussian and are generated mainly by the non-linear behaviour of the undercarriage and the strong occurrence of shocks generated by roughness of the terrain. This non-Gaussian nature is expressed particularly by very high flattening levels that can affect the design of structures under extreme stresses conventionally acquired by spectral approaches, inherent to Gaussian processes and based essentially on spectral moments of stress processes. Due to these technical considerations, techniques for characterisation of random excitation processes generated by this type of carrier need to be changed, by proposing innovative characterisation methods based on time domain approaches as described in the body of the text rather than spectral domain approaches.

  9. Transcending Library Catalogs: A Comparative Study of Controlled Terms in Library of Congress Subject Headings and User-Generated Tags in LibraryThing for Transgender Books

    Science.gov (United States)

    Adler, Melissa

    2009-01-01

    Perhaps the greatest power of folksonomies, especially when set against controlled vocabularies like the Library of Congress Subject Headings, lies in their capacity to empower user communities to name their own resources in their own terms. This article analyzes the potential and limitations of both folksonomies and controlled vocabularies for…

  10. A pilot randomized trial comparing long-term effects of red and white wines on biomarkers of atherosclerosis (in vino veritas: IVV trial).

    Science.gov (United States)

    Taborsky, M; Ostadal, P; Petrek, M

    2012-01-01

    Since early 90', growing body of evidence indicates that the Mediterranean diet with mild to moderate consumption of wine, mostly red wine, has a protective effect on cardiovascular diseases. Several mechanisms have been discussed to participate in the beneficial effect of red wine, such as antioxidant or vasodilating activity. However, later it has been shown that also other alcoholic beverages have a protective effect on atherosclerosis. Up to now, data from the prospective, long-term, head-to-head comparisons of the effects of different drinks on markers of atherosclerosis are insufficient. The IVV (in vino veritas) study is a long-term, prospective, multicenter, randomized trial comparing the effect of red and white wines on the markers of atherosclerosis. One hundred and twenty healthy subjects with mild to moderate risk of atherosclerosis will be randomized to regular consumption of red wine (Pinot Noir) or white wine (Chardonnay-Pinot) for one year. The primary endpoint is the level of HDL-cholesterol at one year, while secondary endpoints are levels of other markers of atherosclerosis (LDL-cholesterol, C-reactive protein, myeloperoxidase, advanced oxidation protein product, interleukins 6 and 18, matrix metalloproteinases, glutathione s-transferase, monocyte chemoattractant protein 1, soluble CD40L). The IVV trial is the first study focusing on the long-term prospective comparison of the effects of red and white wines consumption on HDL-cholesterol and other markers of atherosclerosis. Results of the IVV trial may extend our understanding of the widely discussed "French paradox" (Tab. 1, Ref. 21)

  11. 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...

  12. 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...

  13. 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.

  14. The short-term and long-term effects of tolvaptan in patients with heart failure: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Xiong, Bo; Huang, Yuwen; Tan, Jie; Yao, Yuanqing; Wang, Chunbin; Qian, Jun; Rong, Shunkang; Deng, Shimin; Cao, Yin; Zou, Yanke; Huang, Jing

    2015-11-01

    A comprehensive evaluation of the benefits of tolvaptan for the management of heart failure (HF) is lacking. The objective of this meta-analysis was to assess the short-term and long-term effects of tolvaptan in patients with HF. Articles were searched from PubMed, MEDLINE and Cochrane Library before March 31, 2015. Randomized controlled trials enrolling adult HF patients and reporting the all-cause mortality, cardiac events, body weight change or changes of serum electrolytes including sodium, potassium and creatinine were included in our meta-analysis. Ten studies covering 5574 patients met the inclusion criteria. Based on the data of meta-analysis, tolvaptan had no impact on the all-cause mortality [relative risk (RR) 0.96; 95 % confidence interval (CI) 0.87-1.06; P = 0.40] and incidence of cardiac events (RR 1.03; 95 % CI 0.96-1.11; P = 0.40) of HF patients. Furthermore, in comparison with control treatments, tolvaptan significantly decreased the body weight [weight mean difference (WMD), -0.87; 95 % CI -1.03 to -0.71; P tolvaptan (WMD, 0.05; 95 % CI 0.03-0.07; P tolvaptan may not bring long-term benefits, but it effectively improves the volume overload and hyponatremia without obvious increases in serum potassium and creatinine. Hence, tolvaptan is likely to be a promising diuretic for the treatment of HF.

  15. 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.

  16. Long-term outcomes of exercise: follow-up of a randomized trial in older women with osteopenia.

    Science.gov (United States)

    Korpelainen, Raija; Keinänen-Kiukaanniemi, Sirkka; Nieminen, Pentti; Heikkinen, Jorma; Väänänen, Kalervo; Korpelainen, Juha

    2010-09-27

    Long-term evidence from randomized trials of the effectiveness of exercise in preventing disability and fall-related fractures in elderly people has been lacking. We performed extended follow-up of 160 women (aged 70-73 years at baseline) with osteopenia in a population-based, randomized, controlled exercise trial. The trial was conducted from April 1 through April 30, 2001. Follow-up was conducted from May 1, 2001, through December 31, 2005. Mean total time in observation was 7.1 years. Primary outcome measures were femoral neck bone mineral density, postural sway, and leg strength. Secondary outcome measures were hospital-treated fractures and functional ability measures. Outcomes were measured annually using masked assessors. There was a significant difference between groups in favor of exercise in terms of postural sway (group × time interaction, P = .005), walking speed (group × time interaction, P training seem to have a long-term effect on balance and gait and may even protect high-risk elderly women from hip fractures. clinicaltrials.gov Identifier: NCT00655577.

  17. A Logistic Regression Model with a Hierarchical Random Error Term for Analyzing the Utilization of Public Transport

    Directory of Open Access Journals (Sweden)

    Chong Wei

    2015-01-01

    Full Text Available Logistic regression models have been widely used in previous studies to analyze public transport utilization. These studies have shown travel time to be an indispensable variable for such analysis and usually consider it to be a deterministic variable. This formulation does not allow us to capture travelers’ perception error regarding travel time, and recent studies have indicated that this error can have a significant effect on modal choice behavior. In this study, we propose a logistic regression model with a hierarchical random error term. The proposed model adds a new random error term for the travel time variable. This term structure enables us to investigate travelers’ perception error regarding travel time from a given choice behavior dataset. We also propose an extended model that allows constraining the sign of this error in the model. We develop two Gibbs samplers to estimate the basic hierarchical model and the extended model. The performance of the proposed models is examined using a well-known dataset.

  18. Short-term perioperative treatment with ambroxol reduces pulmonary complications and hospital costs after pulmonary lobectomy: a randomized trial.

    Science.gov (United States)

    Refai, Majed; Brunelli, Alessandro; Xiumé, Francesco; Salati, Michele; Sciarra, Valeria; Socci, Laura; Di Nunzio, Luca; Sabbatini, Armando

    2009-03-01

    To assess in a randomized clinical trial the influence of perioperative short-term ambroxol administration on postoperative complications, hospital stay and costs after pulmonary lobectomy for lung cancer. One hundred and forty consecutive patients undergoing lobectomy for lung cancer (April 2006-November 2007) were randomized in two groups. Group A (70 patients): ambroxol was administered by intravenous infusion in the context of the usual therapy on the day of operation and on the first 3 postoperative days (1000 mg/day). Group B (70 patients): fluid therapy only without ambroxol. Groups were compared in terms of occurrence of postoperative complications, length of stay and costs. There were no dropouts from either group and no complications related to treatment. The two groups were well matched for perioperative and operative variables. Compared to group B, group A (ambroxol) had a reduction of postoperative pulmonary complications (4 vs 13, 6% vs 19%, p=0.02), and unplanned ICU admission/readmission (1 vs 6, 1.4% vs 8.6%, p=0.1) rates. Moreover, the postoperative stay and costs were reduced by 2.5 days (5.6 vs 8.1, p=0.02) and 2765 Euro (2499 Euro vs 5264 Euro, p=0.04), respectively. Short-term perioperative treatment with ambroxol improved early outcome after lobectomy and may be used to implement fast-tracking policies and cut postoperative costs. Nevertheless, other independent trials are needed to verify the effect of this treatment in different settings.

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. Long-term outcome after randomizing prolene hernia system, mesh plug repair and Lichtenstein for inguinal hernia repair.

    Science.gov (United States)

    Nienhuijs, Simon W; Rosman, Camiel

    2015-02-01

    To assess long-term superiority in terms of chronic pain between prolene hernia system (PHS), mesh plug repair (MPR) and Lichtenstein (L) technique for inguinal hernia repair. Eight years after randomizing three commonly used techniques for primary inguinal hernia repair, the outcome was evaluated with a questionnaire measuring pain on verbal descriptor and visual analogue scales, including limitations on daily life activities, sensory disturbances and recurrences. From previous results patients characteristics, operative details and short- and mid-term pain outcome were extracted. 270 out of 308 eligible patients (88%) completed the follow-up after median 7.6 years (range 6.9-9.2) after the inguinal hernia operation. No significant differences between the repair techniques were found for pain, sensory disturbances or recurrences. Overall, the hernia recurrence rate was 6.3%. In total 63 patients (23%) reported long-term pain of which one-fourth graded this moderate to severe. Pain was experienced at least weekly by 26 patients (10%) and limiting daily activities for 36 patients (13%). With regard to the previously reported pain at 3 and 15 months follow-up, 106 patients (39%) experience no pain at all. For 101 patients (37%), initial pain disappeared. 41 patients (15%) suffered persisting pain at all three measure moments. 22 patients (8%) reported pain at 8 years follow-up after an initial pain-free period. Long-term outcome after randomizing PHS, MPR and L showed no clinically relevant differences in chronic pain and its consequences. Although chronic pain is diminishing over time it remains a serious complication and has sometimes an onset long after the inguinal repair.

  5. A randomized comparison of permanent septal versus apical right ventricular pacing: short-term results.

    Science.gov (United States)

    Victor, Frederic; Mabo, Philippe; Mansour, Hassan; Pavin, Dominique; Kabalu, Guillaume; de Place, Christian; Leclercq, Christophe; Daubert, J Claude

    2006-03-01

    This study compared chronic right ventricular (RV) pacing at the septum versus apex. Chronic RV apical pacing may be detrimental to ventricular function. This randomized, pilot study examined whether, compared with apical, permanent septal pacing preserves cardiac function. Ablation of the atrioventricular junction for permanent AF, followed by implantation of a DDDR pacemaker connected to two ventricular leads was performed in 28 patients. One lead screwed into the septum and another placed at the apex were connected to the atrial and ventricular port, respectively. Septum or apex was paced by programming AAIR or VVIR modes, respectively. Patients were randomly assigned, 4 months later, to pacing at one site for 3 months, and crossed over to the other for 3 months. New York Heart Association class, QRS width and axis, left ventricular ejection fraction (LVEF), exercise duration, and peak oxygen uptake were measured. Results in patients with LVEF > 45% and < or = 45% were compared. Septal pacing was associated with shorter QRS (145 +/- 4 msec vs 170 +/- 4 msec, P < 0.01) and normal axis (40 degrees +/- 10 degrees vs -71 +/- 4 degrees , P < 0.01). At 3 months, among patients with baseline LVEF < or = 45%, LVEF was 42 +/- 5% after septal pacing versus 37 +/- 4% after apical pacing (P < 0.001). In contrast to RV apical pacing, chronic RV septal pacing preserved LVEF in patients with baseline LVEF < or = 45%.

  6. Improved work ability and return to work following vocational multidisciplinary rehabilitation of subjects on long-term sick leave

    OpenAIRE

    Braathen, Tore; Veiersted, Kaj Bo; Heggenes, Jan

    2007-01-01

    Objective: To evaluate a vocational multidisciplinary rehabilitation programme for patients on long-term sick leave with respect to their work ability and return to work. Methods: A multidisciplinary rehabilitation programme was administered to an intervention group of 183 patients on long-term sick leave (mean 12.2 months). Effects of the treatment were compared with a control group (n = 96) recruited from the national sickness insurance record of patients on sick leave of 6??2 month...

  7. Physical activity after commitment lotteries: examining long-term results in a cluster randomized trial.

    Science.gov (United States)

    van der Swaluw, Koen; Lambooij, Mattijs S; Mathijssen, Jolanda J P; Schipper, Maarten; Zeelenberg, Marcel; Berkhout, Stef; Polder, Johan J; Prast, Henriëtte M

    2018-02-26

    To overcome self-control difficulties, people can commit to their health goals by voluntarily accepting deadlines with consequences. In a commitment lottery, the winners are drawn from all participants, but can only claim their prize if they also attained their gym-attendance goals. In a 52-week, three-arm trial across six company gyms, we tested if commitment lotteries with behavioral economic underpinnings would promote physical activity among overweight adults. In previous work, we presented an effective 26-week intervention. In the present paper we analyzed maintenance of goal attainment at 52-week follow-up and the development of weight over time. We compared weight and goal attainment (gym attendance ≥ 2 per week) between three arms that-in the intervention period- consisted of (I) weekly short-term lotteries for 13 weeks; (II) the same short-term lotteries in combination with an additional long-term lottery after 26 weeks; and (III) a control arm without lottery-deadlines. After a successful 26-week intervention, goal attainment declined between weeks 27 and 52 in the long-term lottery arm, but remained higher than in the control group. Goal attainment did not differ between the short-term lottery arm and control arm. Weight declined slightly in all arms in the first 13 weeks of the trial and remained stable from there on. Commitment lotteries can support regular gym attendance up to 52 weeks, but more research is needed to achieve higher levels of maintenance and weight loss.

  8. Implementation of a discontinuation letter to reduce long-term benzodiazepine use--a cluster randomized trial.

    Science.gov (United States)

    van de Steeg-van Gompel, Caroline H P A; Wensing, Michel; De Smet, Peter A G M

    2009-01-01

    Although it is recommended to restrict long-term use of benzodiazepines, and considerable attention has been paid to this, long-term use continues to be a problem. An informative discontinuation letter for patients has been shown to reduce long-term benzodiazepine use in general practice. However, little is known about its wide scale implementation in primary care. To determine the effectiveness of an intensive support programme for community pharmacies to send discontinuation letters to patients in cooperation with GPs. In a cluster randomized trial, 43 control pharmacies received a written manual and 47 experimental pharmacies received an intensive support programme. Primary outcome measures were the percentage of GPs who reviewed and returned lists of eligible patients and the percentage of long-term users who were sent a discontinuation letter within 4 months. The outcomes did not differ for the experimental versus control groups: 38% and 31% of the GPs, respectively, returned the patient lists; 14% and 10% of all long-term users in the two groups, respectively, received the discontinuation letter within 4 months. Substantially more pharmacies in the experimental group than in the control group finally managed to send discontinuation letters (70% vs. 40%). About one third of the pharmacies in the control group and two thirds of the pharmacies in the intervention group finally implemented the discontinuation letter. However, this difference was not apparent in the primary outcome measures. It seems crucial to involve GPs more effectively in implementation of the discontinuation letter.

  9. Experimental Testing of Monopiles in Sand Subjected to One-Way Long-Term Cyclic Lateral Loading

    DEFF Research Database (Denmark)

    Roesen, Hanne Ravn; Ibsen, Lars Bo; Andersen, Lars Vabbersgaard

    2013-01-01

    In the offshore wind turbine industry the most widely used foundation type is the monopile. Due to the wave and wind forces the monopile is subjected to a strong cyclic loading with varying amplitude, maximum loading level, and varying loading period. In this paper the soil–pile interaction...

  10. Do subjects with whiplash-associated disorders respond differently in the short-term to manual therapy and exercise than those with mechanical neck pain?

    DEFF Research Database (Denmark)

    Castaldo, Matteo; Catena, Antonella; Chiarotto, Alessandro

    2017-01-01

    OBJECTIVE : To compare the short-term effects of manual therapy and exercise on pain, related disability, range of motion, and pressure pain thresholds between subjects with mechanical neck pain and whiplash-associated disorders. METHODS : Twenty-two subjects with mechanical neck pain and 28...... with whiplash-associated disorders participated. Clinical and physical outcomes including neck pain intensity, neck-related disability, and pain area, as well as cervical range of motion and pressure pain thresholds over the upper trapezius and tibialis anterior muscles, were obtained at baseline and after...... the intervention by a blinded assessor. Each subject received six sessions of manual therapy and specific neck exercises. Mixed-model repeated measures analyses of covariance (ANCOVAs) were used for the analyses. RESULTS : Subjects with whiplash-associated disorders exhibited higher neck-related disability (P = 0...

  11. 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.

  12. Short-term effects of manipulative treatment versus a therapeutic home exercise protocol for chronic cervical pain: A randomized clinical trial.

    Science.gov (United States)

    Galindez-Ibarbengoetxea, Xabier; Setuain, Igor; Ramírez-Velez, Robinson; Andersen, Lars L; González-Izal, Miriam; Jauregi, Andoni; Izquierdo, Mikel

    2018-02-06

    While both manipulative treatment and physical exercises are used to treat cervical pain, it remains unclear which is most effective. To compare the short-term effects of high-velocity, low-amplitude manipulation techniques (MT) with those of home-exercise (HE) with stretching and low-intensity (10% of max) isometric contractions on pain and function. Single-blind randomized clinical trial was performed. A total of 27 asymptomatic subjects were randomly assigned to 2 groups: manipulation techniques (MT, n= 13) and home exercise (HE, n= 14). The visual analogue scale (VAS); neck disability index (NDI); pressure pain thresholds; cervical spine range of motion and electromyography during the cranio-cervical flexion test was measured before and one week after the intervention. After the intervention, both groups showed improved (P< 0.05) NDI and VAS scores and flexion in both rotation ranges compared with the pre-intervention values. For the NDI, pain intensity, and neck flexion, the effects sizes were large; for the majority of the other measurements, the effect sizes were small to moderate. The MT group showed significantly better results than the HE group for 2 out of 17 tests. Both interventions improved function and pain after one week, with only marginal between-group differences in favor of MT.

  13. 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...

  14. 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.

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

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    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.

  16. 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

  17. Combination therapy containing ritonavir plus saquinavir has superior short-term antiretroviral efficacy: a randomized trial

    DEFF Research Database (Denmark)

    Kirk, O; Katzenstein, T L; Gerstoft, J

    1999-01-01

    trial. Two hundred and eighty-four patients started randomized treatment. The primary end-point was the proportion of patients with HIV RNA of 200 copies/ml or less (Roche Amplicor) and HIV RNA of 20 copies/ml or less (Roche ultradirect assay) at 6 months. Analysis was performed as intent......-to-treat, and missing values were accounted for as failures. RESULTS: As of 1 May 1998, 269 patients should have completed 24 weeks of treatment. The proportion of patients with HIV RNA of 200 copies/ml or less was 71% (indinavir), 67% (ritonavir), and 82% (ritonavir + saquinavir), P = 0.07. In antiretroviral drug......-naive patients (n = 119), the corresponding figures were 63, 57, and 89% (P RNA of 200 copies/ml or less (P = 0.90). The same pattern was observed in the ultradirect analysis. All three regimens were generally safe...

  18. Title Epidemic Model of a Concept within the Subject Classes of Patents: A Case Study on the Term RFID

    Directory of Open Access Journals (Sweden)

    Mohammad Tavakolizade Ravari

    2016-12-01

    Full Text Available The current research aims at studying the epidemic model of the term RFID within the classes of patents. Methodology: The research is descriptive and has been conducted based on the mathematical models of diseases. Research population consists of 35,627 granted patents from the USPTO database those which the terms RFID or Radio Frequency Identification occur in their titles or abstracts. Data analysis was performed through software like Excel, SPSS, and Ravar-Matrix. Findings show that the cumulative growth of sub-classes with the term RFID follows an S-logistic model. This is an evidence of natural growth rate for assigning the term RFID to the USPTO sub-classes over the years.  Other finding reveals that the term RFID has been entered into and exited from the sub-classes of patents like the SIS epidemic model of diseases. As a final conclusion, the most technical fields those that are susceptible for RFID technology, have been met this technology. On the base of SIS model, the epidemic of RFID technology has been reached a balance.

  19. Randomized, controlled trial of the effectiveness of short-term dynamic psychotherapy and cognitive therapy for cluster C personality disorders.

    Science.gov (United States)

    Svartberg, Martin; Stiles, Tore C; Seltzer, Michael H

    2004-05-01

    This study compared the effectiveness of short-term dynamic psychotherapy and cognitive therapy for outpatients with cluster C personality disorders. Patients (N=50) who met the criteria for one or more cluster C personality disorders and not for any other personality disorders were randomly assigned to receive 40 weekly sessions of short-term dynamic psychotherapy or cognitive therapy. The most common axis I disorders in the patient group were anxiety and depression diagnoses. Therapists were experienced, full-time clinicians and were receiving manual-guided supervision. Outcome variables included symptom distress, interpersonal problems, and core personality pathology. Measures were administered repeatedly during and after treatment, and change was assessed longitudinally by means of growth modeling procedures. The overall patient group showed, on average, statistically significant improvements on all measures during treatment and also during a 2-year follow-up period. Significant changes in symptom distress after treatment were found for the group of patients who received short-term dynamic psychotherapy but not for the cognitive therapy patients. Despite these differences in intragroup changes, no statistically significant differences between the short-term dynamic psychotherapy group and cognitive therapy group were found on any measure for any time period. Two years after treatment, 54% of the short-term dynamic psychotherapy patients and 42% of the cognitive therapy patients had recovered symptomatically, whereas approximately 40% of the patients in both groups had recovered in terms of interpersonal problems and personality functioning. Both short-term dynamic psychotherapy and cognitive therapy have a place in the treatment of patients with cluster C personality disorders. However, factors other than treatment modality may discriminate better between successful and poor outcomes. Such factors should be explored in future studies.

  20. Long-term Persistence with Mirabegron versus Solifenacin in Women with Overactive Bladder: Prospective, Randomized Trial.

    Science.gov (United States)

    Kinjo, Manami; Sekiguchi, Yuki; Yoshimura, Yasukuni; Nutahara, Kikuo

    2016-12-02

    To compare persistence with medication and the reasons for discontinuation of mirabegron or solifenacin therapy up to12 months in women with overactive bladder (OAB). Female OAB patients who presented to women's urology clinics were enrolled in a prospective, randomized, two-arm study. Patients were randomized to receive mirabegron at 25-50 mg (n = 76) or solifenacin at 2.5-5 mg (n = 72). The persistence rate and the reasons for discontinuation were investigated up to 12 months. The 12-month persistence rate was 12.2% in the mirabegron group versus 20.1% in the solifenacin group and there were no significant differences of the persistence rates during the study (n.s). Patients discontinued treatment because of lack of efficacy (21.6%), spontaneous improvement (18.2%), and side-effects (17.6%), while 19.6% were lost to follow up. Discontinuation due to side-effects was significantly more frequent in the solifenacin group than the mirabegron group (27.3 vs. 7.9%, P < 0.05). In contrast, discontinuation due to lack of efficacy was significantly more frequent in the mirabegron group than the solifenacin group (36.8 vs. 5.6%, P < 0.05). This study demonstrated low persistence rates over 12 months for both mirabegron and solifenacin, although the reasons for discontinuation were somewhat different. © 2016 John Wiley & Sons Australia, Ltd.

  1. Short-term outcome of newborn infants: spinal versus general anesthesia for elective cesarean section. A prospective randomized study.

    Science.gov (United States)

    Kavak, Z N; Başgül, A; Ceyhan, N

    2001-12-10

    To compare general and spinal anesthesia with respect to the short-term outcome of newborns born by elective cesarean deliveries. Pregnant women admitted to our hospital from January 1999 to July 2000, for whom elective repeat cesareans were planned after 37 weeks gestation, were allocated randomly after their informed consent to spinal anesthesia or general anesthesia. Maternal age, gestational age, birth weight, Apgar's score, hospital stay duration, and duration of cesarean section time were all noted. The rate of the neonatal respiratory depression, perinatal asphyxia, and admittance to the neonatal intensive care unit of the infants were documented. We also studied arterial samples withdrawn from the cord for the pH, bicarbonate, PaO(2) (oxygen pressure, arterial), and PaCO(2) (carbon dioxide pressure, arterial). The serum levels of creatine kinase with myocardial-specific isoform, aspartate aminotransferase, alanine aminotransferase, and total cortisol levels of the newborns were measured and served in ruling out perinatal stress and in confirming the diagnosis of perinatal asphyxia (and of myocardial damage). Statistical analyses was performed with the use of an unpaired Student's t-test, Chi-square test, and a power calculation was done. From the randomly selected patients, we had 38 (45.2%) infants for general anesthesia and 46 (54.8%) for spinal anesthesia. None of our primary endpoints favored any of the study groups, and the clinical short-term outcome of the infants was similar in the neonates born both by spinal and general anesthesia (P>0.05). The biochemical assays did not rule out or confirm any differences in the occurrence of perinatal stress (P>0.05). Anesthesia type does not seem to influence the short-term outcome of the newborn infants for the elective cesarean deliveries. We believe that both spinal and general anesthesia could be performed in elective term cesarean deliveries without any risk to the newborn infants.

  2. 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

  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.

    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.

  4. 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.

  5. A short-term evaluation of the relationship between plasma ascorbic acid levels and periodontal disease in systemically healthy and type 2 diabetes mellitus subjects.

    Science.gov (United States)

    Gokhale, Neeraja H; Acharya, Anirudh B; Patil, Vidya S; Trivedi, Dheeraj J; Thakur, Srinath L

    2013-06-01

    Deficient ascorbic acid levels (AALs) and Type 2 diabetes mellitus (T2DM) are associated with periodontal disease. This study evaluated the relationship between plasma AAL and periodontitis in systemically healthy and T2DM subjects, which to the best of our knowledge is being reported for the first time. One hundred twenty subjects were categorized into four groups of 30 each as group 1: without periodontal disease; group 2: chronic gingivitis; group 3: chronic periodontitis, and group 4: chronic periodontitis and freshly diagnosed T2DM. Plaque index (PlI), sulcus bleeding index (SBI), and probing pocket depths (PPDs) were evaluated. Venous blood was evaluated for plasma AAL spectrophotometrically. Randomized subjects were subgrouped within groups 2-4, to receive either scaling and root planing (SRP) with dietary supplementation (450 mg) of ascorbic acid (AA) for two weeks or only SRP. After two weeks, the clinical parameters were reassessed. Tukey's multiple post hoc procedures and paired t test were used with the level of statistical significance adjusted to p ≤ .05. AAL plasma levels were significantly greater in group 1 than in group 2 (p = .0007) and in group 4 (p = .0003). A significant reduction in the SBI was seen in the subgroups that received dietary supplementation of vitamin C within group 2 (p = .0012) and group 4 (p = .036). Plasma AAL is below the normal range in systemically healthy subjects with gingivitis and diabetics with periodontitis. Dietary AA supplementation with SRP improves the SBI in subjects with gingivitis and diabetics with periodontitis.

  6. 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.

  7. Increased Serum PAI-1 Levels in Subjects with Metabolic Syndrome and Long-Term Adverse Mental Symptoms: A Population-Based Study

    Directory of Open Access Journals (Sweden)

    Anne Huotari

    2010-01-01

    Full Text Available Depression is an independent risk factor for cardiovascular diseases and is associated with metabolic syndrome (MetS. Levels of plasminogen activator inhibitor-1 (PAI-1, an inhibitor of tissue-type and urokinase-type plasminogen activators, are associated with MetS. To clarify the role of PAI-1 in subjects with long-term adverse mental symptomatology (LMS; including depression and MetS, we measured circulating PAI-1 levels in controls (n=111, in subjects with MetS and free of mental symptoms (n=42, and in subjects with both MetS and long-term mental symptoms (n=70. PAI-1 increased linearly across the three groups in men. In logistic regression analysis, men with PAI-1 levels above the median had a 3.4-fold increased likelihood of suffering from the comorbidity of long-term adverse mental symptoms and MetS, while no such associations were detected in women. In conclusion, our results suggest that in men high PAI-1 levels are independently associated with long-term mental symptomatology.

  8. Medium term effects of kinesio taping in patients with chronic non-specific low back pain: a randomized controlled trial.

    Science.gov (United States)

    Araujo, Amanda Costa; do Carmo Silva Parreira, Patrícia; Junior, Luiz Carlos Hespanhol; da Silva, Tatiane Mota; da Luz Junior, Maurício Antônio; da Cunha Menezes Costa, Lucíola; Pena Costa, Leonardo Oliveira

    2016-12-23

    Kinesio taping is a commonly used intervention for patients with chronic low back pain. However, the medium term effects of kinesio taping in these patients are unknown. To investigate the effectiveness of kinesio taping in patients with chronic low back pain after 6 months from randomization. This was a randomized controlled trial with a 6 months follow up. One hundred and forty eight participants were randomly assigned to the experimental (kinesio taping with skin convolutions) or control (kinesio taping without convolutions-Sham Taping) group. Participants from both groups had the tape reapplied twice a week for four weeks. The outcomes were pain, disability and global impression of recovery after 6 months. One participant was lost to follow up in the experimental group (n=73, response rate 99%) and two in the control group (n=72, response rate 97%). After 6 months there were no statistically significant between-group differences in pain intensity (between-group difference -0.8 points, 95% CI -1.7 to 0.2), global impression of recovery (0.4, -0.7 to 1.5), or disability (-1.1, -3.0 to 0.7). Four weeks of kinesio taping treatment was no better than sham taping for patients with chronic low back pain, at 6 months follow-up. Trial Registration Number (http://www.ensaiosclinicos.gov.br/): RBR-7ggfkv (Brazilian Registry of Clinical Trials). Copyright © 2017 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  9. 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.

  10. Psychomotor and Memory Effects of Haloperidol, Olanzapine, and Paroxetine in Healthy Subjects After Short-Term Administration

    NARCIS (Netherlands)

    Morrens, M.; Wezenberg, E.; Verkes, R.J.; Hulstijn, W.; Ruigt, G.S.F.; Sabbe, B.G.C.

    2007-01-01

    Rationale: Impaired psychomotor function has been shown to be associated with clinical and functional outcome in schizophrenia. However, few studies have investigated the short-term effects of antipsychotics on the cognitive and psychomotor functions of this patient group. Because many confounding

  11. Psychomotor and memory effects of haloperidol, olanzapine, and paroxetine in healthy subjects after short-term administration.

    NARCIS (Netherlands)

    Morrens, M.; Wezenberg, E.; Verkes, R.J.; Hulstijn, W.; Ruigt, G.S.F.; Sabbe, B.G.C.

    2007-01-01

    RATIONALE: Impaired psychomotor function has been shown to be associated with clinical and functional outcome in schizophrenia. However, few studies have investigated the short-term effects of antipsychotics on the cognitive and psychomotor functions of this patient group. Because many confounding

  12. Short-term and long-term effects of a progressive resistance and balance exercise program in individuals with chronic stroke: a randomized controlled trial.

    Science.gov (United States)

    Vahlberg, Birgit; Cederholm, Tommy; Lindmark, Birgitta; Zetterberg, Lena; Hellström, Karin

    2017-08-01

    To evaluate the effects of progressive resistance and balance (PRB) exercises on physical and psychological functions of post-stroke individuals. In a randomized controlled trial with follow-up at 3, 6 and 15 months, 67 community-living individuals (76% male; 65-85 years) with a stroke 1-3 years previously were allocated to an intervention group (IG, n = 34; PRB exercises combined with motivational group discussions twice weekly for 3 months) or a control group (CG, n = 33). The primary outcomes were balance (Berg Balance Scale, 0-56 points) and mobility (Short Physical Performance Battery, 0-12 points) at 3 months. The secondary outcomes were 10 m comfortable walking speed, physical activity levels, health-related quality of life, depression and fall-related self-efficacy. At 3 months, the IG exhibited significant improvements in balance (MD 2.5 versus 0 points; effect size [ES], 0.72; p resistance and balance exercise program supported by motivational group discussions and one home-based exercise appears to be an effective means of improving the short-term balance and the walking speed in individuals with chronic stroke. People with poor balance and motor function discontinued the study more often and may require additional support. There is a need for powerful and cost-effective strategies that target changes in behavior to obtain long-term changes in physical function after exercising.

  13. Isotonic versus hypotonic fluid supplementation in term neonates with severe hyperbilirubinemia - a double-blind, randomized, controlled trial.

    Science.gov (United States)

    Balasubramanian, Karthik; Kumar, Praveen; Saini, Shiv Sajan; Attri, Savita Verma; Dutta, Sourabh

    2012-03-01

    To compare the incidence of hyponatremia in full-term neonates with severe hyperbilirubinemia, receiving intravenous fluid supplementation with 0.2% saline in 5% dextrose versus 0.9% saline in 5% dextrose, to prevent blood exchange transfusion (BET). In this double-blind, randomized, controlled trial, full-term newborns (≥37 weeks), appropriate for gestational age, with severe non-haemolytic hyperbilirubinemia (serum bilirubin ≥ 20 mg/dL) were enrolled. Eligible neonates were randomized to receive either 0.2% saline in 5% dextrose (hypotonic fluid group) or 0.9% saline in 5% dextrose (isotonic fluid group) over 8 hrs, in addition to phototherapy. The primary outcome was proportion of neonates developing hyponatremia (serum Na hypotonic fluid group as compared to isotonic fluid group (48.8% vs. 10.5%, p hypotonic fluid to prevent BET was associated with a higher incidence of hyponatremia while isotonic fluid was associated with an increased incidence of hypernatremia. © 2011 The Author(s)/Acta Paediatrica © 2011 Foundation Acta Paediatrica.

  14. The intrastromal corneal ring in penetrating keratoplasty-long-term results of a prospective randomized study.

    Science.gov (United States)

    Birnbaum, Florian; Schwartzkopff, Johannes; Böhringer, Daniel; Reinhard, Thomas

    2011-07-01

    Postoperative astigmatism after penetrating keratoplasty is a major problem in corneal transplantation. The purpose of this prospective randomized study was to evaluate the efficacy and safety of an intrastromal corneal ring after penetrating keratoplasty. Twenty patients were included, 10 of whom received an intracorneal ring (group 1) and 10 who did not (group 2, control group). Astigmatism in Orbscan corneal topography, occurrence of immune reactions, and occurrence of side effects were this study's main outcome criteria. Mean follow-up time was 27.6 ± 5.3 months. Mean astigmatism (Orbscan) was 4.4 diopters in group 1 and 4.4 diopters in group 2 (P = 0.695). Spontaneous suture rupture occurred in 5 patients with corneal ring but in none of those in the control group. We observed 3 immune reactions in 3 patients with corneal ring, whereas group 2 experienced no rejection (P keratoplasty caused no reduction in postoperative astigmatism. However, its use was statistically significantly associated with adverse events.

  15. Proteome Analysis of Thyroid Cancer Cells After Long-Term Exposure to a Random Positioning Machine

    Science.gov (United States)

    Pietsch, Jessica; Bauer, Johann; Weber, Gerhard; Nissum, Mikkel; Westphal, Kriss; Egli, Marcel; Grosse, Jirka; Schönberger, Johann; Eilles, Christoph; Infanger, Manfred; Grimm, Daniela

    2011-11-01

    Annulling gravity during cell culturing triggers various types of cells to change their protein expression in a time dependent manner. We therefore decided to determine gravity sensitive proteins and their period of sensitivity to the effects of gravity. In this study, thyroid cancer cells of the ML-1 cell line were cultured under normal gravity (1 g) or in a random positioning machine (RPM), which simulated near weightlessness for 7 and 11 days. Cells were then sonicated and proteins released into the supernatant were separated from those that remained attached to the cell fragments. Subsequently, both types of proteins were fractionated by free-flow isoelectric focussing (FF-IEF). The fractions obtained were further separated by sodium dodecyl sulphate polyacrylamide gel electrophoresis (SDS-PAGE) to which comparable FF-IEF fractions derived from cells cultured either under 1 g or on the RPM had been applied side by side. The separation resulted in pairs of lanes, on which a number of identical bands were observed. Selected gel pieces were excised and their proteins determined by mass spectrometry. Equal proteins from cells cultured under normal gravity and the RPM, respectively, were detected in comparable gel pieces. However, many of these proteins had received different Mascot scores. Quantifying heat shock cognate 71 kDa protein, glutathione S-transferase P, nucleoside diphosphate kinase A and annexin-2 by Western blotting using whole cell lysates indicated usefulness of Mascot scores for selecting the most efficient antibodies.

  16. Transvaginal/Transumbilical Hybrid—NOTES—Versus 3-Trocar Needlescopic Cholecystectomy: Short-term Results of a Randomized Clinical Trial

    Science.gov (United States)

    Knuth, Jürgen; Cerasani, Nicola; Sauerwald, Axel; Lefering, Rolf; Heiss, Markus Maria

    2015-01-01

    Objective: For cholecystectomy, both the needlescopic cholecystectomy (NC) 3-trocar technique using 2 to 3 mm trocars and the umbilical-assisted transvaginal cholecystectomy (TVC) technique have found their way into clinical routine. This study compares these 2 techniques in female patients who are in need of an elective cholecystectomy. Background: Natural orifice transluminal endoscopic surgery (NOTES) is a surgical concept permitting scarless intra-abdominal operations through natural orifices, such as the vagina. Because of the lack of an adequately powered trial, we designed this first randomized controlled study for the comparison of TVC and NC. Methods: This prospective, randomized, nonblinded, single-center trial evaluates the safety and effectiveness of TVC (intervention), compared with NC (control) in female patients with symptomatic cholecystolithiasis. The primary endpoint was intensity of pain until the morning of postoperative day (POD) 2. Secondary outcomes were among others intra- and postoperative complications, procedural time, amount of analgesics used, pain intensity until POD 10, duration of hospital stay, satisfaction with the aesthetic result, and quality of life on POD 10 as quantified with the Eypasch Gastrointestinal Quality of Life Index (GIQLI). Results: Between February 2010 and June 2012, 40 patients were randomly assigned to the interventional or control group. All patients completed follow-up. Procedural time, length of postoperative hospital stay, and the rate of intra- and postoperative complications were similar in the 2 groups. However, significant advantages were found for the transvaginal access regarding pain until POD 2, but also until POD 10 (P = 0.043 vs P = 0.010) despite significantly less use of peripheral analgesics (P = 0.019). In the TVC group, patients were significantly more satisfied with the aesthetic result (P < 0.001) and had a significantly better GIQLI (P = 0.028). Conclusions: Although comparable in terms of

  17. Transvaginal/transumbilical hybrid--NOTES--versus 3-trocar needlescopic cholecystectomy: short-term results of a randomized clinical trial.

    Science.gov (United States)

    Bulian, Dirk Rolf; Knuth, Jürgen; Cerasani, Nicola; Sauerwald, Axel; Lefering, Rolf; Heiss, Markus Maria

    2015-03-01

    For cholecystectomy, both the needlescopic cholecystectomy (NC) 3-trocar technique using 2 to 3 mm trocars and the umbilical-assisted transvaginal cholecystectomy (TVC) technique have found their way into clinical routine. This study compares these 2 techniques in female patients who are in need of an elective cholecystectomy. Natural orifice transluminal endoscopic surgery (NOTES) is a surgical concept permitting scarless intra-abdominal operations through natural orifices, such as the vagina. Because of the lack of an adequately powered trial, we designed this first randomized controlled study for the comparison of TVC and NC. This prospective, randomized, nonblinded, single-center trial evaluates the safety and effectiveness of TVC (intervention), compared with NC (control) in female patients with symptomatic cholecystolithiasis. The primary endpoint was intensity of pain until the morning of postoperative day (POD) 2. Secondary outcomes were among others intra- and postoperative complications, procedural time, amount of analgesics used, pain intensity until POD 10, duration of hospital stay, satisfaction with the aesthetic result, and quality of life on POD 10 as quantified with the Eypasch Gastrointestinal Quality of Life Index (GIQLI). Between February 2010 and June 2012, 40 patients were randomly assigned to the interventional or control group. All patients completed follow-up. Procedural time, length of postoperative hospital stay, and the rate of intra- and postoperative complications were similar in the 2 groups. However, significant advantages were found for the transvaginal access regarding pain until POD 2, but also until POD 10 (P = 0.043 vs P = 0.010) despite significantly less use of peripheral analgesics (P = 0.019). In the TVC group, patients were significantly more satisfied with the aesthetic result (P < 0.001) and had a significantly better GIQLI (P = 0.028). Although comparable in terms of safety, TVC caused less pain, increased satisfaction

  18. Effects of Short-Term Dynamic Constant External Resistance Training and Subsequent Detraining on Strength of the Trained and Untrained Limbs: A Randomized Trial

    Directory of Open Access Journals (Sweden)

    Pablo B. Costa

    2016-01-01

    Full Text Available Short-term resistance training has been shown to increase isokinetic muscle strength and performance after only two to nine days of training. The purpose of this study was to examine the effects of three days of unilateral dynamic constant external resistance (DCER training and detraining on the strength of the trained and untrained legs. Nineteen men were randomly assigned to a DCER training group or a non-training control group. Subjects visited the laboratory eight times, the first visit was a familiarization session, the second visit was a pre-training assessment, the subsequent three visits were for training sessions (if assigned to the training group, and the last three visits were post-training assessments 1, 2, and 3 (i.e., 48 h, 1 week, and 2 weeks after the final training session. Strength increased in both trained and untrained limbs from pre- to post-training assessment 1 for the training group and remained elevated at post-training assessments 2 and 3 (p ≤ 0.05. No changes were observed in the control (p > 0.05. Possible strength gains from short-term resistance training have important implications in clinical rehabilitation settings, sports injury prevention, as well as other allied health fields such as physical therapy, occupational therapy, and athletic training.

  19. Long-Term Use of Probiotics Lactobacillus and Bifidobacterium Has a Prophylactic Effect on the Occurrence and Severity of Pouchitis: A Randomized Prospective Study

    Directory of Open Access Journals (Sweden)

    Banasiewicz Tomasz

    2014-01-01

    Full Text Available Aim. The aim of the study was to assess the impact of the long-term use of the composite probiotics in patients after restorative proctocolectomy. Method. Forty-three patients (20 females and 23 males, aged 21 to 68 years after restorative proctocolectomy were included in the study. After randomization patients were divided into placebo group and treatment group with oral intake of probiotic containing Lactobacillus acidophilus, Lactobacillus delbrueckii subsp. bulgaricus, and Bifidobacterium bifidus. Patients were investigated during initial visit and during final visit after 9 months. All patients were subjected to standard clinical and endoscopic examination with microscopic study of the specimens. Concentrations of calprotectin and pyruvate kinase isoenzyme M2-PK were determined in all cases. Results. The average severity of pouchitis and the number of patients with pouchitis significantly decrease after 9 months of the probiotic taking. The concentrations of calprotectin and pyruvate kinase isoenzyme M2-PK significantly decreased after the therapy. Conclusions. Nine months of the probiotic treatment (Lactobacillus acidophilus, Lactobacillus delbrueckii subsp. bulgaricus, and Bifidobacterium bifidus reduced the number of patients with pouchitis, decreased the PDAI score, and also decreased the fecal pyruvate kinase and calprotectin. The long-term probiotics use is safe and well accepted and can be an effective method of the pouchitis prevention.

  20. Cost-Effectiveness of a Long-Term Internet-Delivered Worksite Health Promotion Programme on Physical Activity and Nutrition: A Cluster Randomized Controlled Trial

    Science.gov (United States)

    Robroek, Suzan J. W.; Polinder, Suzanne; Bredt, Folef J.; Burdorf, Alex

    2012-01-01

    This study aims to evaluate the cost-effectiveness of a long-term workplace health promotion programme on physical activity (PA) and nutrition. In total, 924 participants enrolled in a 2-year cluster randomized controlled trial, with departments (n = 74) within companies (n = 6) as the unit of randomization. The intervention was compared with a…

  1. Long-term effect of lisinopril and atenolol on kidney function in hypertensive NIDDM subjects with diabetic nephropathy

    DEFF Research Database (Denmark)

    Nielsen, F S; Rossing, P; Gall, M A

    1997-01-01

    The aim of our study was to evaluate whether inhibition of ACE (lisinopril 10-20 mg/day) can reduce the rate of decline in kidney function more than reducing blood pressure with conventional antihypertensive treatment (atenolol 50-100 mg/day), usually in combination with a diuretic. We performed...... a prospective, randomized, parallel study for 42 months, double blind for the first 12 months and single blind thereafter. Forty-three (21 lisinopril and 22 atenolol) hypertensive NIDDM patients with diabetic nephropathy were enrolled. Data from 36 patients (17 lisinopril and 19 atenolol, 60 +/- 7 years of age...... sustained decline (6 to 42 months) of 0.59 +/- 0.10 and 0.54 +/- 0.13 ml x min(-1) x month(-1) in the lisinopril and atenolol groups, respectively. No significant differences were observed in either initial or sustained decline in glomerular filtration rate between the two groups. Urinary albumin excretion...

  2. Tonsillectomy or tonsillotomy?--A randomized study comparing postoperative pain and long-term effects.

    Science.gov (United States)

    Hultcrantz, E; Linder, A; Markström, A

    1999-12-15

    tonsillectomy (TE) is currently the most common treatment for children with snoring and sleep apnea. Many of these children have not had any severe throat infections. To cure such children from their obstructive problems, without influencing the immunological function of the tonsils, tonsillotomy (TT) with CO2-laser was performed in a randomized study comparing it to regular tonsillectomy, with special attention to postoperative pain and symptom recurrence. 41 children 3.5-8 years-old were included--21 'TT's' and 20 'TE's'. They were all operated under the same anesthesia and followed the same postoperative scheme for analgesia. A visual analogue scale for pain measurements with faces was used for the first 24 h. After that, each day until pain-free, the parents registered the child's pain on a three graded scale, what the child was able to eat, and the amount of analgesic drugs used. all the children were cured from their breathing obstruction. The mean time used for the surgery was the same and no postoperative bleeding was seen in either group. 'TT children' were pain-free after 5 days and 'TE children' after 8 days. Eight to ten days after surgery, the TT-children had gained weight and the TE children lost weight significantly. The TE group used twice as much analgesic drugs as the TT group during the first postoperative week. The TT group was healed with normal-looking, but small tonsils after 8-10 days; the TE group often still showed edema and crusts. At the one-year follow-up 2/21 among the 'TT-children' snored, but did not require re-surgery. tonsillotomy is much less painful than TE and children recover more quickly. Results with respect to breathing obstruction are almost the same for both methods at 1-year follow-up.

  3. Training-induced changes in muscle CSA, muscle strength, EMG, and rate of force development in elderly subjects after long-term unilateral disuse

    DEFF Research Database (Denmark)

    Suetta, Charlotte; Aagaard, Per; Rosted, Anna

    2004-01-01

    The ability to develop muscle force rapidly may be a very important factor to prevent a fall and to perform other tasks of daily life. However, information is still lacking on the range of training-induced neuromuscular adaptations in elderly humans recovering from a period of disuse. Therefore......, the present study examined the effect of three types of training regimes after unilateral prolonged disuse and subsequent hip-replacement surgery on maximal muscle strength, rapid muscle force [rate of force development (RFD)], muscle activation, and muscle size. Thirty-six subjects (60-86 yr) were randomized...... to a 12-wk rehabilitation program consisting of either 1) strength training (3 times/wk for 12 wk), 2) electrical muscle stimulation (1 h/day for 12 wk), or 3) standard rehabilitation (1 h/day for 12 wk). The nonoperated side did not receive any intervention and thereby served as a within-subject control...

  4. Short- and Long-Term Effectiveness of a Subject's Specific Novel Brain and Vestibular Rehabilitation Treatment Modality in Combat Veterans Suffering from PTSD.

    Science.gov (United States)

    Carrick, Frederick Robert; Pagnacco, Guido; McLellan, Kate; Solis, Ross; Shores, Jacob; Fredieu, Andre; Brock, Joel Brandon; Randall, Cagan; Wright, Cameron; Oggero, Elena

    2015-01-01

    Treatment for post-traumatic stress disorder (PTSD) in combat veterans that have a long-term positive clinical effect has the potential to modify the treatment of PTSD. This outcome may result in changed and saved lives of our service personnel and their families. In a previous before-after-intervention study, we demonstrated high statistical and substantively significant short-term changes in the Clinician Administered DSM-IV PTSD Scale (CAPS) scores after a 2-week trial of a subject's particular novel brain and vestibular rehabilitation (VR) program. The long-term maintenance of PTSD severity reduction was the subject of this study. We studied the short- and long-term effectiveness of a subject's particular novel brain and VR treatment of PTSD in subjects who had suffered combat-related traumatic brain injuries in terms of PTSD symptom reduction. The trial was registered as ClinicalTrials.gov Identifier: NCT02003352. We analyzed the difference in the CAPS scores pre- and post-treatment (1 week and 3 months) using our subjects as their matched controls. The generalized least squares (GLS) technique demonstrated that with our 26 subjects in the 3 timed groups the R (2) within groups was 0.000, R (2) between groups was 0.000, and overall the R (2) was 0.000. The GLS regression was strongly statistically significant z = 21.29, p < 0.001, 95% CI [58.7, 70.63]. The linear predictive margins over time demonstrated strong statistical and substantive significance of decreasing PTSD severity scores for all timed CAPS tests. Our investigation has the promise of the development of superior outcomes of treatments in this area that will benefit a global society. The length of the treatment intervention involved (2 weeks) is less that other currently available treatments and has profound implications for cost, duration of disability, and outcomes in the treatment of PTSD in combat veterans.

  5. Short and long term effectiveness of a subject's specific novel brain and vestibular rehabilitation treatment modality in combat veterans suffering from PTSD

    Directory of Open Access Journals (Sweden)

    Frederick Robert Carrick

    2015-06-01

    Full Text Available AbstractIntroduction: Treatment for post-traumatic stress disorder (PTSD in combat veterans that have a long-term positive clinical effect has the potential to modify the treatment of PTSD. This outcome may result in changed and saved lives of our service personnel and their families. In a previous before-after-intervention study we demonstrated high statistical and substantively significant short-term changes in the Clinician Administered DSM-IV PTSD Scale (CAPS scores after a two week trial of a subject's particular novel brain and vestibular rehabilitation (VR program. The long-term maintenance of PTSD severity reduction was the subject of this study.Material and Methods:We studied the short and long term effectiveness of a subject's particular novel brain and VR treatment of PTSD in subjects who had suffered combat-related traumatic brain injuries in terms of PTSD symptom reduction. The trial was registered as ClinicalTrials.gov Identifier: NCT02003352. We analyzed the difference in the CAPS scores pre and post treatment (one week and three months using our subjects as their matched controls. Results:The generalized least squares (GLS technique demonstrated that with our 26 subjects in the 3 timed groups the R2 within groups was 0.000, R2 between groups was 0.000 and overall the R2 was 0.000. The GLS regression was strongly statistically significant z = 21.29, p < 0.001, 95% CI [58.7, 70.63]. The linear predictive margins over time demonstrated strong statistical and substantive significance of decreasing PTSD severity scores for all timed CAPS tests.Discussion:Our investigation has the promise of the development of superior outcomes of treatments in this area that will benefit a global society. The length of the treatment intervention involved (two weeks is less that other currently available treatments and has profound implications for cost, duration of disability and outcomes in the treatment of PTSD in combat veterans.

  6. 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

  7. Effect of Lactobacillus on body weight and body fat in overweight subjects: a systematic review of randomized controlled clinical trials.

    Science.gov (United States)

    Crovesy, L; Ostrowski, M; Ferreira, D M T P; Rosado, E L; Soares-Mota, M

    2017-11-01

    Gut microbiota is important for maintaining body weight. Modulation of gut microbiota by probiotics may result in weight loss and thus help in obesity treatment. The aim of this systematic review was to evaluate the effects of Lactobacillus on weight loss and/or fat mass in overweight adults. A search was performed on the Medline (PubMed) and Scopus electronic databases using the search terms: 'probiotics', 'Lactobacillus, 'obesity', 'body weight changes', 'weight loss', 'overweight', 'abdominal obesity', 'body composition', 'body weight', 'body fat' and 'fat mass'. In the total were found 1567 articles, but only 14 were included in this systematic review. Of these nine showed decreased body weight and/or body fat, three did not find effect and two showed weight gain. Results suggest that the beneficial effects are strain dependent. It can highlight that Lactobacillus plantarum and Lactobacillus rhamnosus when combined with a hypocaloric diet, L. plantarum with Lactobacillus curvatus, Lactobacillus gasseri, Lactobacillus amylovorus, Lactobacillus acidophilus and Lactobacillus casei with phenolic compounds, and multiple species of Lactobacillus.

  8. A short-term, comprehensive, yoga-based lifestyle intervention is efficacious in reducing anxiety, improving subjective well-being and personality

    Science.gov (United States)

    Yadav, Raj Kumar; Magan, Dipti; Mehta, Manju; Mehta, Nalin; Mahapatra, Sushil Chandra

    2012-01-01

    Objective: To assess the efficacy of a short-term comprehensive yoga-based lifestyle intervention in reducing anxiety, improving subjective well-being and personality. Materials and Methods: The study is a part of an ongoing larger study at a tertiary care hospital. Participants (n=90) included patients with chronic diseases attending a 10-day, yoga-based lifestyle intervention program for prevention and management of chronic diseases, and healthy controls (n=45) not attending any such intervention. Primary Outcome Measures: Change in state and trait anxiety questionnaire (STAI-Y; 40 items), subjective well-being inventory (SUBI; 40 items), and neuroticism extraversion openness to experience five factor personality inventory revised (NEO-FF PI-R; 60 items) at the end of intervention. Results: Following intervention, the STAI-Y scores reduced significantly (Panxiety and improve subjective well-being and personality in patients with chronic diseases. PMID:22869998

  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. 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.

  16. 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.

  17. 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

  18. Photodynamic therapy in non-surgical treatment of chronic periodontitis: short term randomized clinical trial study

    Science.gov (United States)

    Russo, C.; Palaia, G.; Loskutova, E.; Libotte, F.; Kornblit, R.; Gaimari, G.; Tenore, G.; Romeo, U.

    2016-03-01

    Introduction: Periodontitis is a chronic inflammatory disease due to exposition to plaque and tartar. Conventional treatments consist of scaling and root planing (SRP) and antibiotics administration. Among them encouraging results have been obtained using alternative protocols, like the antimicrobial photodynamic therapy (PDT). Aim of the Study: Evaluation of PDT effects added to conventional methods. Materials and Methods: 11 patients (4M/7F, 37-67 years aged, non-smoking) affected by untreated chronic periodontal disease, with >3mm pockets in at least 4 teeth were divided in two groups, test and control group. Each patient had to made full-intraoral before and after the treatment. The test group received SRP+PDT, while the control group was subjected to SRP. The PDT was performed through the HELBO®TheraLite (Bredent Medical), diode laser battery powered 670nm with an output of 75mW/cm2. The Helbo Blue photosensitizer, containing methylene blue, was used. The exposure time to the laser effect was of 10'' for each site, for a total of 60'' at 3J/cm2. Results: Both groups had a significant improvement in the reduction of pocket depth (PD), above all in the test group. Statistical analysis was performed through the T-test, evaluating PD between the two groups p=0.96 (p> 0.05), resulting not statistically significant. Conclusion: PDT is a promising support to SRP, achieving a significant reduction in the pocket depth, but more cases are needed to confirm the validity of the used protocol.

  19. Do exercises with the Foam Roller have a short-term impact on the thoracolumbar fascia? - A randomized controlled trial.

    Science.gov (United States)

    Griefahn, Annika; Oehlmann, Jan; Zalpour, Christoff; von Piekartz, Harry

    2017-01-01

    Due to new research results in the past few years, interest in the fascia of the human body has increased. Dysfunctions of the fascia are indicated by various symptoms, amongst others, musculoskeletal pain. As a result stronger focus has been put on researching therapeutic approaches in this area. The main aim of this study was to investigate the effect of Foam Roll exercises on the mobility of the thoracolumbar fascia (TLF). Study has been conducted in a randomized and controlled trial which sampled 38 healthy athletic active men and women. The subjects were randomly assigned to a Foam Roll Group (FMG), a Placebo Group (PG) and a Control Group (CG). Depending on the assigned group the volunteers were either instructed to do exercises with the Foam Roll, received a pseudo treatment with the Foam Roll or received no treatment. A total of three measurements were carried out. The most important field of research was the mobility of the TLF, which was determined using a sonographic assessment. In addition the lumbar flexion and the mechanosensivity of relevant muscles were determined. After the intervention, the FMG showed an average increase of 1.7915 mm for the mobility of the TLF (p fascia in a healthy young population. Copyright © 2016 Elsevier Ltd. All rights reserved.

  20. Knemometry Assessment of Short-term Growth in Children With Asthma Receiving Fluticasone Furoate for 2 Weeks: A Randomized, Placebo-controlled, Crossover Trial.

    Science.gov (United States)

    Wolthers, Ole D; Stone, Sally; Bareille, Philippe; Tomkins, Susan; Khindri, Sanjeev

    2017-06-01

    A dry powder inhaler formulation of the inhaled corticosteroid fluticasone furoate (FF) is being evaluated for use in children. An important potential risk associated with the use of inhaled corticosteroids in children is growth suppression. Therefore, the aim of this study was to assess the short-term lower leg growth in children with asthma treated for 2 weeks with inhaled FF versus placebo from the ELLIPTA inhaler. Prepubertal children with persistent asthma (n = 60; aged 5 to <12 years) were recruited into a randomized, double-blind, placebo-controlled, 2-way crossover, noninferiority study. The study consisted of four 2-week periods: run-in, 2 treatment periods, 1 washout period, and a 1-week follow-up period. Interventions were FF 50 µg and placebo once daily in the evening. Lower leg length was measured by using knemometry. The randomized ITT population comprised 36 boys and 24 girls with a mean age of 8.7 (standard deviation, 1.5; range, 5-11) years; 58% had a duration of asthma ≥5 years. Fifty-eight subjects completed both treatment periods. The least squares mean growth rate was 0.31 mm/week during treatment with FF and 0.36 mm/week during the placebo period. The difference in adjusted least squares mean growth rates between FF and placebo was -0.052 mm/week with a 95% CI of -0.122 to 0.018. This finding was greater than the prespecified noninferiority margin of -0.20 mm/week. The overall incidence of adverse events was 35% with placebo and 22% with FF. Inhaled FF 50 µg provided once daily for 2 weeks was noninferior to placebo in terms of effects on short-term lower leg growth in children with asthma. To further quantify the risk of growth suppression in children, intermediate-term growth studies should be conducted. Inhaled FF 50 µg was well tolerated in this study population. ClinicalTrials.gov identifier: NCT02502734. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  1. 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

  2. Long-term effects of a Palaeolithic-type diet in obese postmenopausal women: a 2-year randomized trial.

    Science.gov (United States)

    Mellberg, C; Sandberg, S; Ryberg, M; Eriksson, M; Brage, S; Larsson, C; Olsson, T; Lindahl, B

    2014-03-01

    Short-term studies have suggested beneficial effects of a Palaeolithic-type diet (PD) on body weight and metabolic balance. We now report the long-term effects of a PD on anthropometric measurements and metabolic balance in obese postmenopausal women, in comparison with a diet according to the Nordic Nutrition Recommendations (NNR). Seventy obese postmenopausal women (mean age 60 years, body mass index 33 kg/m(2)) were assigned to an ad libitum PD or NNR diet in a 2-year randomized controlled trial. The primary outcome was change in fat mass as measured by dual-energy X-ray absorptiometry. Both groups significantly decreased total fat mass at 6 months (-6.5 and-2.6 kg) and 24 months (-4.6 and-2.9 kg), with a more pronounced fat loss in the PD group at 6 months (Pdiet regarding fat mass, abdominal obesity and triglyceride levels in obese postmenopausal women; effects not sustained for anthropometric measurements at 24 months. Adherence to protein intake was poor in the PD group. The long-term consequences of these changes remain to be studied.

  3. 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.

  4. 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.

  5. 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.

  6. Short-term effects of cervical kinesio taping on pain and cervical range of motion in patients with acute whiplash injury: a randomized clinical trial.

    Science.gov (United States)

    González-Iglesias, Javier; Fernández-de-Las-Peñas, César; Cleland, Joshua A; Huijbregts, Peter; Del Rosario Gutiérrez-Vega, Maria

    2009-07-01

    Randomized clinical trial. To determine the short-term effects of Kinesio Taping, applied to the cervical spine, on neck pain and cervical range of motion in individuals with acute whiplash-associated disorders (WADs). Researchers have begun to investigate the effects of Kinesio Taping on different musculoskeletal conditions (eg, shoulder and trunk pain). Considering the demonstrated short-term effectiveness of Kinesio Tape for the management of shoulder pain, it is suggested that Kinesio Tape may also be beneficial in reducing pain associated with WAD. Forty-one patients (21 females) were randomly assigned to 1 of 2 groups: the experimental group received Kinesio Taping to the cervical spine (applied with tension) and the placebo group received a sham Kinesio Taping application (applied without tension). Both neck pain (11-point numerical pain rating scale) and cervical range-of-motion data were collected at baseline, immediately after the Kinesio Tape application, and at a 24-hour follow-up by an assessor blinded to the treatment allocation of the patients. Mixed-model analyses of variance (ANOVAs) were used to examine the effects of the treatment on each outcome variable, with group as the between-subjects variable and time as the within-subjects variable. The primary analysis was the group-by-time interaction. The group-by-time interaction for the 2-by-3 mixed-model ANOVA was statistically significant for pain as the dependent variable (F = 64.8; PKinesio Taping experienced a greater decrease in pain immediately postapplication and at the 24-hour follow-up (both, PKinesio Taping, applied with proper tension, exhibited statistically significant improvements immediately following application of the Kinesio Tape and at a 24-hour follow-up. However, the improvements in pain and cervical range of motion were small and may not be clinically meaningful. Future studies should investigate if Kinesio Taping provides enhanced outcomes when added to physical therapy

  7. Short-term objective and subjective evaluation of small-diameter implants used to support and retain mandibular prosthesis.

    Science.gov (United States)

    Brandt, Robert; Hollis, Scott; Ahuja, Swati; Adatrow, Pradeep; Balanoff, William

    2012-01-01

    The introduction of small-diameter implants has provided dentists the means of providing edentulous and partially edentulous patients with immediate functioning transitional prostheses while definitive restorations are being fabricated. The successful use of these small-diameter implants for temporary stabilization of prostheses has led many clinicians to explore the option of using them as a definitive alternative, especially as the technique requires minimal time and also is economical for the patients. To date, there has been no study with multiple patients looking at both the subjective and objective outcomes of these small-diameter implants. Twenty-seven edentulous patients were enrolled in this study, seven of them were smokers. One-hundred and eight small-diameter (2.0 mm, MDL) implants were surgically placed in 24 edentulous mandibles. All implants were immediately loaded. The patients filled out a screening questionnaire and four subsequent questionnaires to test their satisfaction with the altered prosthesis at 6, 12, 18 and 24 months. The survival of the implants was also noted. Smokers had an implant survival of 79%. Non-smokers had an implant survival of 100%. The results of the questionnaire indicated an overall satisfaction with the implant-supported prosthesis.

  8. Randomized cross-over trial of short-term water-only fasting: metabolic and cardiovascular consequences.

    Science.gov (United States)

    Horne, B D; Muhlestein, J B; Lappé, D L; May, H T; Carlquist, J F; Galenko, O; Brunisholz, K D; Anderson, J L

    2013-11-01

    Routine, periodic fasting is associated with a lower prevalence of coronary artery disease (CAD). Animal studies show that fasting may increase longevity and alter biological parameters related to longevity. We evaluated whether fasting initiates acute changes in biomarker expression in humans that may impact short- and long-term health. Apparently-healthy volunteers (N = 30) without a recent history of fasting were enrolled in a randomized cross-over trial. A one-day water-only fast was the intervention and changes in biomarkers were the study endpoints. Bonferroni correction required p ≤ 0.00167 for significance (p fasting intervention acutely increased human growth hormone (p = 1.1 × 10⁻⁴), hemoglobin (p = 4.8 × 10⁻⁷), red blood cell count (p = 2.5 × 10⁻⁶), hematocrit (p = 3.0 × 10⁻⁶), total cholesterol (p = 5.8 × 10⁻⁵), and high-density lipoprotein cholesterol (p = 0.0015), and decreased triglycerides (p = 1.3 × 10⁻⁴), bicarbonate (p = 3.9 × 10⁻⁴), and weight (p = 1.0 × 10⁻⁷), compared to a day of usual eating. For those randomized to fast the first day (n = 16), most factors including human growth hormone and cholesterol returned to baseline after the full 48 h, with the exception of weight (p = 2.5 × 10⁻⁴) and (suggestively significant) triglycerides (p = 0.028). Fasting induced acute changes in biomarkers of metabolic, cardiovascular, and general health. The long-term consequences of these short-term changes are unknown but repeated episodes of periodic short-term fasting should be evaluated as a preventive treatment with the potential to reduce metabolic disease risk. Clinical trial registration (ClinicalTrials.gov): NCT01059760 (Expression of Longevity Genes in Response to Extended Fasting [The Fasting and Expression of Longevity Genes during Food abstinence {FEELGOOD} Trial]). Copyright © 2012 Elsevier B.V. All rights reserved.

  9. Short-Term Effect of Laser Acupuncture on Lower Back Pain: A Randomized, Placebo-Controlled, Double-Blind Trial

    Directory of Open Access Journals (Sweden)

    Jae-Young Shin

    2015-01-01

    Full Text Available Purpose. This trial was performed to investigate the efficacy of laser acupuncture for the alleviation of lower back pain. Methods. This was a randomized, placebo-controlled, double-blind trial. Fifty-six participants were randomly assigned to either the laser acupuncture group (n=28 or the sham laser acupuncture group (n=28. Participants in both groups received three treatment sessions over the course of one week. Thirteen acupuncture points were selected. The visual analogue scale for pain, pressure pain threshold, Patient Global Impression of Change, and Euro-Quality-of-Life Five Dimensions questionnaire (Korean version were used to evaluate the effect of laser acupuncture treatment on lower back pain. Results. There were no significant differences in any outcome between the two groups, although the participants in both groups showed a significant improvement in each assessed parameter relative to the baseline values. Conclusion. Although there was no significant difference in outcomes between the two groups, the results suggest that laser acupuncture can provide effective pain alleviation and can be considered an option for relief from lower back pain. Further studies using long-term intervention, a larger sample size, and rigorous methodology are required to clarify the effect of laser acupuncture on lower back pain.

  10. Referral from primary care to a physical activity programme: establishing long-term adherence? A randomized controlled trial. Rationale and study design

    Directory of Open Access Journals (Sweden)

    Puig-Ribera Anna

    2009-01-01

    Full Text Available Abstract Background Declining physical activity is associated with a rising burden of global disease. There is little evidence about effective ways to increase adherence to physical activity. Therefore, interventions are needed that produce sustained increases in adherence to physical activity and are cost-effective. The purpose is to assess the effectiveness of a primary care physical activity intervention in increasing adherence to physical activity in the general population seen in primary care. Method and design Randomized controlled trial with systematic random sampling. A total of 424 subjects of both sexes will participate; all will be over the age of 18 with a low level of physical activity (according to the International Physical Activity Questionnaire, IPAQ, self-employed and from 9 Primary Healthcare Centres (PHC. They will volunteer to participate in a physical activity programme during 3 months (24 sessions; 2 sessions a week, 60 minutes per session. Participants from each PHC will be randomly allocated to an intervention (IG and control group (CG. The following parameters will be assessed pre and post intervention in both groups: (1 health-related quality of life (SF-12, (2 physical activity stage of change (Prochaska's stages of change, (3 level of physical activity (IPAQ-short version, (4 change in perception of health (vignettes from the Cooperative World Organization of National Colleges, Academies, and Academic Associations of Family Physicians, COOP/WONCA, (5 level of social support for the physical activity practice (Social Support for Physical Activity Scale, SSPAS, and (6 control based on analysis (HDL, LDL and glycated haemoglobin. Participants' frequency of visits to the PHC will be registered over the six months before and after the programme. There will be a follow up in a face to face interview three, six and twelve months after the programme, with the reduced version of IPAQ, SF-12, SSPAS, and Prochaska's stages

  11. Short-term Antiarrhythmic Drugs After Catheter Ablation for Atrial Fibrillation: A Meta-analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Xu, Buyun; Peng, Fang; Tang, Weiliang; Du, Ye; Guo, Hangyuan

    2016-09-01

    The incidence of recurrent arrhythmia after catheter ablation (CA) for atrial fibrillation (AF) is unacceptable. Short-term antiarrhythmic drug (AAD) treatment following CA was presumed to be effective in reducing recurrent arrhythmia. To fully evaluate the efficacy of short-term use of AADs following CA for AF in preventing recurrence of atrial tachyarrhythmias. PubMed, Embase, Cochrane Library, and ClinicalTrials.gov were searched up until May 1, 2016. We enrolled randomized controlled trials (RCTs) that evaluated the efficacy of short-term use of AADs following CA for AF in preventing early and/or late recurrence of atrial tachyarrhythmias. The statistical analyses were performed using Review Manager Version 5.3. Six RCTs were included in this analysis, involving a total of 2764 patients. The frequency of early recurrence of atrial tachyarrhythmias was 39.5% in the AAD group (556 of 1407) and 47.2% (640 of 1357) in the control group. The pooled risk ratio of the AAD group to the control group was 0.78 (95% CI = 0.62-0.98). Regarding late recurrence of AF (LRAF), the incidence in the AAD group and the control group was 32.5% (420 of 1293) and 34.6% (450 of 1300), respectively. No significant difference was identified between the 2 groups (relative risk = 0.94, 95% CI = 0.85-1.05). Short-term use of AADs following CA for AF reduced the incidence of early recurrent atrial tachyarrhythmias but did not prevent LRAF. © The Author(s) 2016.

  12. Long-term efficacy and safety of carotid artery stenting versus endarterectomy: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Li, Yang; Yang, Jing-Jing; Zhu, Su-Hui; Xu, Biao; Wang, Lian

    2017-01-01

    Many recent trials have investigated the long-term efficacy and safety of endarterectomy versus stenting in treating patients with carotid artery stenosis. We aimed to determine the long-term comparative efficacy and safety of both procedures by pooling this evidence in a meta-analysis. We searched PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials for studies published until May 6, 2016. Randomized controlled trials, which reported outcomes of interest with a median follow-up of at least 4-year, were included. Eight trials involving 7005 patients and 41824 patient-years of follow-up were included. In terms of the periprocedural outcomes, stenting was associated with a lower risk of myocardial infarction (OR: 0.51; 95% CI: 0.33 to 0.80; P = 0.003) but a higher risk of death or stroke (the composite endpoint, OR: 1.76; 95% CI: 1.38 to 2.25; P endarterectomy (OR: 1.09; 95% CI: 0.95 to 1.26; P = 0.21) and restenosis (OR: 1.48 (95% CI: 0.93 to 2.35; P = 0.10). No evidence of significant heterogeneity was found in any of the analyses. Carotid endarterectomy was found to be superior to stenting for short- and long-term outcomes, although endarterectomy was associated with a higher risk of periprocedural myocardial infarction. Carotid endarterectomy should be offered as the first choice for carotid stenosis at present, however, more evidence is needed because rapid progress in concurrent devices and medical treatments is being made.

  13. The long-term outcome of transcutaneous electrical nerve stimulation in the treatment for patients with chronic pain: a randomized, placebo-controlled trial.

    NARCIS (Netherlands)

    Oosterhof, J.; Wilder-Smith, O.H.G.; Boo, T.M. de; Oostendorp, R.A.B.; Crul, B.J.P.

    2012-01-01

    Background: Transcutaneous electrical nerve stimulation (TENS) is an easy to use analgesic intervention. However, long-term randomized placebo-controlled studies with treatment periods of more than 3 months have not been executed to date. The aim of our study is to explore the long-term (1 year)

  14. 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.

  15. 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.

  16. 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.

  17. Effects of short-term very low-calorie diet on intramyocellular lipid and insulin sensitivity in nondiabetic and type 2 diabetic subjects.

    Science.gov (United States)

    Lara-Castro, Cristina; Newcomer, Bradley R; Rowell, Jennifer; Wallace, Penny; Shaughnessy, Sara M; Munoz, A Julian; Shiflett, Alanna M; Rigsby, Dana Y; Lawrence, Jeannine C; Bohning, Daryl E; Buchthal, Steven; Garvey, W Timothy

    2008-01-01

    The study aimed to analyze the effects of a short-term very low-calorie diet (VLCD) on intramyocellular lipid (IMCL), total body fat, and insulin sensitivity in a group of obese nondiabetic and type 2 diabetic subjects. Seven untreated type 2 diabetic and 5 obese nondiabetic individuals were studied before and after a 6-day VLCD using proton magnetic resonance spectroscopy to quantify IMCL, dual-energy x-ray absorptiometry to assess body fat, and hyperinsulinemic-euglycemic clamps to measure peripheral insulin sensitivity. In both groups, decrements in total body fat mass and body mass index were small but statistically significant. In contrast, the diet resulted in a pronounced reduction in IMCL compared with baseline values in nondiabetic subjects (56% decrease) and type 2 diabetic subjects (40% decrease) (P increase in maximally stimulated glucose disposal rate (P lipid was significantly correlated with insulin sensitivity (r = -0.69, P insulin sensitivity was related to measures of general adiposity such as body mass index, percentage of body fat, or total body fat (P = not significant). In conclusion, short-term VLCD is accompanied by small decrements in general adiposity, marked decrease in IMCL, and an increase in insulin sensitivity in nondiabetic and type 2 diabetic subjects. Therefore, rapid amelioration of insulin resistance by VLCD can be partially explained by loss of IMCL both in nondiabetic and type 2 diabetic subjects in the absence of substantial changes in total body fat. These observations are consistent with the idea that insulin resistance is more directly related to IMCL rather than to body fat per se.

  18. Long-term adherence to antimuscarinic drugs when treating overactive bladder in the older: Subjective reason and objective factors

    Directory of Open Access Journals (Sweden)

    Kirill Vladimirovich Kosilov

    2017-03-01

    Full Text Available Purpose: Comparison of subjective reasons for the refusal of antimuscarinic treatment and the state of objective economic, social, psychological and health status markers in the elderly with overactive bladder. Materials and Methods: One thousand seven hundred thirty-six (1,736 patients participated in the experiment: 1,036 or 59.7% of women, and 700 or 40.3% of men aged over 60 years (average age, 68.1 years who took antimuscarinic (AM drugs during the year. The control of objective parameters was carried out by studying patients’ medical records, the use of overactive bladder questionnaire short form and Medical Outcomes Study 36-item Shor-Form Health Survey, voiding diaries, uroflowmetry, as well as income certificates from the Tax Inspectorate, support documentation for expenses on drugs. Results: Fifty-two point six percent (52.6% of patients preserved adherence to treatment during the first 6 months, 30.1% – during the follow-up period. The average time of reaching a 30-day break in the AM drugs administration was 174 days. In 36.5% of cases of the refusal of treatment, patients referred to medical reasons for the refusal, in 31.6% of cases disturbance was established in objective health status markers (differences were significant in 30% of the follow-up time. The percentage of refusals of treatment for social and psychological reasons (13.2% was significantly lower (p≤0.05, than the percentage of individuals with statuses altered objectively (21.9%. Conclusions: A significant share of elderly patients taking AM drugs when treating overactive bladder is inclined to overestimate the importance of health factors influencing their decisions and to underestimate the importance of social and psychological factors, and an urologist should take it into account for the efficacy evaluation.

  19. Long-term adherence to antimuscarinic drugs when treating overactive bladder in the older: Subjective reason and objective factors.

    Science.gov (United States)

    Kosilov, Kirill Vladimirovich; Loparev, Sergay Alexandrovich; Kuzina, Irina Gennadyevna; Geltser, Boris Izrailevich; Shakirova, Olga Viktorovna; Zhuravskaya, Natalya Sergeevna; Lobodenko, Alexandra

    2017-03-01

    Comparison of subjective reasons for the refusal of antimuscarinic treatment and the state of objective economic, social, psychological and health status markers in the elderly with overactive bladder. One thousand seven hundred thirty-six (1,736) patients participated in the experiment: 1,036 or 59.7% of women, and 700 or 40.3% of men aged over 60 years (average age, 68.1 years) who took antimuscarinic (AM) drugs during the year. The control of objective parameters was carried out by studying patients' medical records, the use of overactive bladder questionnaire short form and Medical Outcomes Study 36-item Shor-Form Health Survey, voiding diaries, uroflowmetry, as well as income certificates from the Tax Inspectorate, support documentation for expenses on drugs. Fifty-two point six percent (52.6%) of patients preserved adherence to treatment during the first 6 months, 30.1% - during the follow-up period. The average time of reaching a 30-day break in the AM drugs administration was 174 days. In 36.5% of cases of the refusal of treatment, patients referred to medical reasons for the refusal, in 31.6% of cases disturbance was established in objective health status markers (differences were significant in 30% of the follow-up time). The percentage of refusals of treatment for social and psychological reasons (13.2%) was significantly lower (p≤0.05), than the percentage of individuals with statuses altered objectively (21.9%). A significant share of elderly patients taking AM drugs when treating overactive bladder is inclined to overestimate the importance of health factors influencing their decisions and to underestimate the importance of social and psychological factors, and an urologist should take it into account for the efficacy evaluation.

  20. Proficiency in Positive versus Negative Emotion Identification and Subjective Well-being among Long-term Married Elderly Couples

    Directory of Open Access Journals (Sweden)

    Raluca ePetrican

    2014-04-01

    Full Text Available Evidence is accruing that positive emotions play a crucial role in shaping a healthy interpersonal climate. Inspired by this research, the current investigation sought to shed light on the link between proficiency in identifying positive versus negative emotions and a close partner’s well-being. To this end, we conducted two studies with neurologically intact elderly married couples (Study 1 and an age-matched clinical sample, comprising married couples in which one spouse had been diagnosed with Parkinson’s Disease (Study 2, which tends to hinder emotional expressivity. To assess proficiency in identifying emotions from whole body postures, we had participants in both studies complete a pointlight walker task, featuring four actors (two male, two female expressing one positive (i.e., happiness and three negative (i.e., sadness, anger, fear basic emotions. Participants also filled out measures of subjective well-being. Among Study 1’s neurologically intact spouses, greater expertise in identifying positive (but not negative emotions was linked to greater partner life satisfaction (but not hedonic balance. Spouses of PD patients exhibited increased proficiency in identifying positive emotions relative to controls, possibly reflective of compensatory mechanisms. Complementarily, relative to controls, spouses of PD patients exhibited reduced proficiency in identifying negative emotions and a tendency to underestimate their intensity. Importantly, all of these effects attenuated with longer years from PD onset. Finally, there was evidence that it was increased partner expertise in identifying negative (rather than positive emotional states that predicted greater life satisfaction levels among the PD patients and their spouses. Our results thus suggest that positive versus negative emotions may play distinct roles in close relationship dynamics as a function of neurological status and disability trajectory.

  1. Proficiency in positive vs. negative emotion identification and subjective well-being among long-term married elderly couples.

    Science.gov (United States)

    Petrican, Raluca; Moscovitch, Morris; Grady, Cheryl

    2014-01-01

    Evidence is accruing that positive emotions play a crucial role in shaping a healthy interpersonal climate. Inspired by this research, the current investigation sought to shed light on the link between proficiency in identifying positive vs. negative emotions and a close partner's well-being. To this end, we conducted two studies with neurologically intact elderly married couples (Study 1) and an age-matched clinical sample, comprising married couples in which one spouse had been diagnosed with Parkinson's Disease (Study 2), which tends to hinder emotional expressivity. To assess proficiency in identifying emotions from whole body postures, we had participants in both studies complete a pointlight walker task, featuring four actors (two male, two female) expressing one positive (i.e., happiness) and three negative (i.e., sadness, anger, fear) basic emotions. Participants also filled out measures of subjective well-being. Among Study 1's neurologically intact spouses, greater expertise in identifying positive (but not negative) emotions was linked to greater partner life satisfaction (but not hedonic balance). Spouses of PD patients exhibited increased proficiency in identifying positive emotions relative to controls, possibly reflective of compensatory mechanisms. Complementarily, relative to controls, spouses of PD patients exhibited reduced proficiency in identifying negative emotions and a tendency to underestimate their intensity. Importantly, all of these effects attenuated with longer years from PD onset. Finally, there was evidence that it was increased partner expertise in identifying negative (rather than positive) emotional states that predicted greater life satisfaction levels among the PD patients and their spouses. Our results thus suggest that positive vs. negative emotions may play distinct roles in close relationship dynamics as a function of neurological status and disability trajectory.

  2. 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

  3. 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

  4. 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

  5. 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

  6. Personality disorder moderates outcome in short- and long-term group analytic psychotherapy: A randomized clinical trial.

    Science.gov (United States)

    Lorentzen, Steinar; Ruud, Torleif; Fjeldstad, Anette; Høglend, Per A

    2015-06-01

    In a randomized clinical trial, short- and long-term psychodynamic group psychotherapy (STG and LTG, respectively) schedules were equally effective for the 'typical' patient during a 3-year study period. Although several studies have reported good effects for patients with personality disorders (PD) in diverse forms of psychotherapy, the significance of treatment duration is unclear. Therefore, we tested the hypothesis that PD patients would improve more during and after LTG than STG. A randomized, longitudinal, prospective study contrasting the outcomes during and after short- and long-term dynamic group psychotherapies. One hundred and sixty-seven outpatients with mood disorders, anxiety disorders, or PD were randomized to STG or LTG (respectively, 20 or 80 weekly sessions of 90 min each). Outcome measures are as follows: symptoms (SCL-90-R), interpersonal problems (IIP-C), and psychosocial functioning (GAF split version: GAF-Symptom and GAF-Function). PD pathology (number of PD criteria items) was selected a priori as a putative moderator of treatment effects. Change during the 3-year study period was assessed using linear mixed models. The study was registered at ClinicalTrials.gov as NCT 00021417. Our hypothesis was supported, as patients with PD improved significantly more regarding all outcome variables in LTG than STG. For patients without PD, the rate of change was similar across 3 years; however, the rate of change in symptoms and interpersonal problems was higher in STG during the first 6 months. The effectiveness of LTG is higher for patients with co-morbid PD. Patients without PD do not appear to experience additional gain from LTG. Clinical implications: LTG demonstrates better effectiveness than STG for patients with personality disorder co-morbidity (PD). Patients without PD do not appear to experience additional gain from attending LTG. Correct initial allocation to treatment duration may prevent disruptive breaks in relationships and lead to both

  7. 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.

  8. 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.

  9. Short-term corneal changes with gas-permeable contact lens wear in keratoconus subjects: a comparison of two fitting approaches.

    Science.gov (United States)

    Romero-Jiménez, Miguel; Santodomingo-Rubido, Jacinto; Flores-Rodríguez, Patricia; González-Méijome, Jose-Manuel

    2015-01-01

    To evaluate changes in anterior corneal topography and higher-order aberrations (HOA) after 14-days of rigid gas-permeable (RGP) contact lens (CL) wear in keratoconus subjects comparing two different fitting approaches. Thirty-one keratoconus subjects (50 eyes) without previous history of CL wear were recruited for the study. Subjects were randomly fitted to either an apical-touch or three-point-touch fitting approach. The lens' back optic zone radius (BOZR) was 0.4mm and 0.1mm flatter than the first definite apical clearance lens, respectively. Differences between the baseline and post-CL wear for steepest, flattest and average corneal power (ACP) readings, central corneal astigmatism (CCA), maximum tangential curvature (KTag), anterior corneal surface asphericity, anterior corneal surface HOA and thinnest corneal thickness measured with Pentacam were compared. A statistically significant flattening was found over time on the flattest and steepest simulated keratometry and ACP in apical-touch group (all pcontact lens wear (all plens wear. Copyright © 2014 Spanish General Council of Optometry. Published by Elsevier Espana. All rights reserved.

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

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    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

  11. 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.

  12. 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

  13. 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.

  14. Randomized Comparison of Isosorbide Mononitrate and PGE2 Gel for Cervical Ripening at Term including High Risk Pregnancy

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    Kavita Agarwal

    2014-01-01

    Full Text Available Aims. Prostaglandin E2 is the most commonly used drug for cervical ripening prior to labour induction. However, there are concerns regarding uterine tachysystole and nonreassuring fetal heart (N-RFH. Isosorbide mononitrate (IMN has been used successfully for cervical ripening. The present study was conducted to compare the two drugs for cervical ripening at term in hospital. Methods. Two hundred women with term pregnancies referred for induction of labour with Bishop score less than 6 were randomly allocated to receive either 40 mg IMN tablet vaginally (n=100 or 0.5 mg PGE2 gel intracervically (n=100. Adverse effects, progress, and outcomes of labour were assessed. Results. PGE2 group had significantly higher postripening mean Bishop score, shorter time from start of medication to vaginal delivery (13.37 ± 10.67 hours versus 30.78 ± 17.29 hours, and shorter labour-delivery interval compared to IMN group (4.53 ± 3.97 hours versus 7.34 ± 5.51 hours. However, PGE2 group also had significantly higher incidence of uterine tachysystole (15% and N-RFH (11% compared to none in IMN group, as well as higher caesarean section rate (27% versus 17%. Conclusions. Cervical ripening with IMN was less effective than PGE2 but resulted in fewer adverse effects and was safer especially in high risk pregnancies.

  15. Beneficial Effects of Long-Term CPAP Treatment on Sleep Quality and Blood Pressure in Adherent Subjects With Obstructive Sleep Apnea.

    Science.gov (United States)

    Yang, Mei-Chen; Huang, Yi-Chih; Lan, Chou-Chin; Wu, Yao-Kuang; Huang, Kuo-Feng

    2015-12-01

    Obstructive sleep apnea (OSA) is associated with increased risk of cardiovascular diseases. Although CPAP is the first treatment choice for moderate-to-severe OSA, acceptance of and adherence to CPAP remain problematic. High CPAP adherence is generally defined as ≥4 h of use/night for ≥70% of the nights monitored. We investigated the long-term beneficial effects of CPAP on sleep quality and blood pressure in subjects with moderate-to-severe OSA according to high or low CPAP adherence. We retrospectively analyzed 121 subjects with moderate-to-severe OSA from August 2008 to July 2012. These subjects were divided into 3 groups: (1) no CPAP treatment (n = 29), (2) low CPAP adherence (n = 28), and (3) high CPAP adherence (n = 64). All subjects were followed up for at least 1 y. The 3 groups were compared regarding anthropometric and polysomnographic variables, presence of cardiovascular comorbidities, and blood pressure at baseline and at the last follow-up. The no-treatment group showed significant increases in oxygen desaturation index and blood pressure. The high-adherence group showed significant improvement in daytime sleepiness, apnea-hypopnea index (AHI), oxygen desaturation index, and blood pressure. Although the AHI was also significantly decreased after CPAP treatment in the low-adherence group, blood pressure remained unchanged. CPAP treatment had beneficial effects on both sleep quality and blood pressure only in subjects with OSA and high CPAP adherence who used CPAP for ≥4 h/night for ≥70% of nights monitored. Subjects with low CPAP adherence received beneficial effects on AHI, but not blood pressure. Copyright © 2015 by Daedalus Enterprises.

  16. Comparison of Dietary Macro and Micro Nutrient Intake between Iranian Patients with Long-term Complications of Sulphur Mustard Poisoning and Healthy Subjects.

    Science.gov (United States)

    -Mood, Mahdi Balali; Zilaee, Marzie; -Mobarhan, Majid Ghayour; Sheikh-Andalibi, Mohammad Sobhan; Mohades-Ardabili, Hossein; Dehghani, Hamideh; Ferns, Gordon

    2014-01-01

    Patients with long-term complications of sulfur mustard (SM) poisoning are often less able to undertake optimum levels of physical activity and adequately control their dietary intake. The aim of present study was to investigate the dietary intake of patients with SM poisoning in comparison to a control group Methods: The study was undertaken on 55 Iranian male veterans, who had > 25% disabilities due to long-term complications of SM poisoning and 55 men age-matched healthy subjects. A previously validated food frequency questionnaire (FFQ) was used for measuring dietary macro/micro nutrient intake for both groups; and the results were analysed using Dietplan6 software. Analysis of macro/micro nutrients in dietary intakes of the patients versus the controls showed a significantly lower intake of several nutrients including selenium and carbohydrate. On the other hand, the dietary intake of trans-fatty acids and iodine were significantly higher in these patients. Long-term complications of SM poisoning in the Iranian veterans induce both chemical and physical disabilities. Macro/micro nutrient intake in these patients was significantly different in comparison with matched, healthy subjects. Dietary advice for these patients should be strongly recommended to these patients in order to prevent other chronic diseases.

  17. Effectiveness of zinc supplementation to full term normal infants: a community based double blind, randomized, controlled, clinical trial.

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    K V Radhakrishna

    Full Text Available UNLABELLED: The study was aimed to test whether zinc supplementation, if initiated early, can prevent stunting and promote optimum body composition in full term infants. For this, full term pregnant women from low income urban community were enrolled and were followed-up for 24 months postpartum. Body mass index (BMI was calculated from maternal weight and height that were collected one month after delivery. Infants' weight, and length, head, chest and mid upper arm circumferences and skin fold thicknesses at triceps, biceps and subscapular area were collected at baseline (before randomization and once in three months up till 24 months. Three hundred and twenty four infants were randomized and allocated to zinc (163 or placebo (161 groups respectively. Supplementation of zinc was initiated from 4 months of age and continued till children attained 18 months. The control (placebo group of children received riboflavin 0.5 mg/day, whereas the intervention (zinc group received 5 mg zinc plus riboflavin 0.5 mg/day. When infants were 18 months old, dietary intakes (in 78 children were calculated by 24 hour diet recall method and hemoglobin, zinc, copper and vitamin A were quantified in blood samples collected from 70 children. The results showed prevalence of undernutrition (body mass index <18.5 in 37% of the mothers. Mean±SD calorie consumption and zinc intakes from diets in infants were 590±282.8 Kcal/day and 0.97±0.608 mg/day respectively. Multiple linear regression models demonstrated maternal weight as a strong predictor of infants' weight and length at 18 months of age. As expected, diarrhea duration impacted infants' linear growth and weight gain adversely. Zinc supplementation for a mean period of 190 days, starting from 4 months up to 18 months of age, in full term normal infants, consuming an average energy of 590 Kcal/day, had significant effect on the skin fold thicknesses, but not on their linear growth. TRIAL REGISTRATION: Clinical

  18. Reproducibility and seasonal variation of ambulatory short-term heart rate variability in healthy subjects during a self-selected rest period and during sleep.

    Science.gov (United States)

    Kristiansen, Jesper; Olsen, Annemarie; Skotte, Jørgen H; Garde, Anne Helene

    2009-01-01

    Although ambulatory measurements of heart rate variability (HRV) are widely used, the reproducibility and seasonal variation of ambulatory sampled short-term HRV measurements in healthy participants has not been investigated before. In the present study we collected ambulatory ECGs from 19 healthy participants monthly for 12 months, and for a sub-group of 12 participants weekly for one month. Frequency-domain HRV-metrics were calculated for 5 min ECG segments during (i) a 15-min self-selected rest period (awake period), and (ii) a 30-min sleep period starting 45 min after estimated sleep onset. Total, within- and between-subject coefficient of variation (CV) and seasonal variation were estimated for ln (TP), ln (LFP), ln (HFP), ln (LF/HF), LFnu, HFnu, the mean heart period and the ECG derived respiratory frequency.The within- and between-subject CV varied considerably between different variables, from 100% for ln (LF/HF). Within- and between-subject CV of ln (HFP), LFnu and HFnu were 10-40%. A weak, but significant, seasonal variation was found for ln (TP) (p = 0.05), ln (LFP) (p<0.05) and the respiratory frequency (p<0.01), but the seasonal variation did not affect the within-subject CV. Furthermore, sample size calculations demonstrated that the reproducibility was sufficient for ambulatory HRV measurements to be used to study autonomic cardiac regulation in healthy populations.

  19. FIVE-YEAR OUTCOMES AFTER LONG-TERM OXANDROLONE ADMINISTRATION IN SEVERELY BURNED CHILDREN: A RANDOMIZED CLINICAL TRIAL.

    Science.gov (United States)

    Reeves, Patrick T; Herndon, David N; Tanksley, Jessica D; Jennings, Kristofer; Klein, Gordon L; Mlcak, Ronald P; Clayton, Robert P; Crites, Nancy N; Hays, Joshua P; Andersen, Clark; Lee, Jong O; Meyer, Walter; Suman, Oscar E; Finnerty, Celeste C

    2016-04-01

    Administration of oxandrolone, a nonaromatizable testosterone analog, to children for 12 months following severe burn injury has been shown to improve height, increase bone mineral content (BMC), reduce cardiac work, and augment muscle strength. Surprisingly, the increase in BMC persists well beyond the period of oxandrolone administration. This study was undertaken to determine if administration of oxandrolone for 2 years yields greater effects on long-term BMC and bone mineral density (BMD). Patients between 0 and 18 years of age with ≥30% of total body surface area burned were consented to an IRB-approved protocol and randomized to receive either placebo (n = 84) or 0.1 mg/kg oxandrolone orally twice daily for 24 months (n = 35). Patients were followed prospectively from the time of admission until 5 years postburn in a single-center, intent-to-treat setting. Height, weight, BMC, and BMD were recorded annually through 5 years postinjury. The long-term administration of oxandrolone for 16 ± 1 months postburn (range, 12.1-25.2 months) significantly increased whole-body (WB) BMC (p burned pediatric patients significantly improves WB BMC, LS BMC, LS BMD, and height velocity. The administration of long-term oxandrolone was more efficacious than administration for 12 months. Additionally, fewer patients in the oxandrolone cohort met the diagnostic criteria for pediatric osteoporosis, pointing to a reduced risk for future bone fracture. This study demonstrates that administering oxandrolone for up to 2 years following severe burn injury results in greater improvements in BMC, BMD, and height velocity.

  20. Achievement emotions in elementary, middle, and high school: how do students feel about specific contexts in terms of settings and subject-domains?

    Science.gov (United States)

    Raccanello, Daniela; Brondino, Margherita; De Bernardi, Bianca

    2013-12-01

    The present work investigates students' representation of achievement emotions, focusing in context-specific situations in terms of settings and subject-domains, as a function of grade level. We involved 527 fourth-, seventh-, and eleventh-graders, who evaluated ten discrete emotions through questionnaires, with reference to verbal language and mathematics, and different settings (class, homework, tests). Confirmatory multitrait-multimethod analyses indicated higher salience of subject-domains rather than settings for all the emotions; however, complexity of reality was best explained when also settings were accounted for. Analyses of variance revealed higher intensity of positive emotions for younger students, and the opposite pattern for older students; significant differences for most of the emotions based on the evaluative nature of settings, moderated by class levels; more intense positive emotions for mathematics and more intense negative emotions for Italian. Results are discussed considering their theoretical and applied relevance, corroborating previous literature on domain-specificity. © 2013 The Scandinavian Psychological Associations.

  1. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

  3. 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.

  4. 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.

  5. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

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

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    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.

  8. The long-term effect of a zinc acetate and chlorhexidine diacetate containing mouth rinse on intra-oral halitosis-A randomized clinical trial.

    Science.gov (United States)

    Erovic Ademovski, Seida; Mårtensson, Carina; Persson, Gösta Rutger; Renvert, Stefan

    2017-10-01

    To evaluate the long-term effects of a zinc acetate and chlorhexidine diacetate mouth rinse (Zn/CHX) on intra-oral halitosis. Forty-six adults with intra-oral halitosis were randomized into a 6-month, double-blind, placebo-controlled clinical study. The presence of intra-oral halitosis was evaluated at baseline, 3 and 6 months after treatment by assessment of organoleptic score (OLS) and by total volatile sulphur compounds (T-VSC), hydrogen sulphide (H2 S) and methyl mercaptan (MM) concentrations in exhaled air. A Zn/CHX mouth rinse provided significantly better control of intra-oral halitosis than a placebo mouth rinse. At 3 and 6 months, individuals rinsing with the Zn/CHX rinse presented with reductions of the OLS, T-VSC (p oral halitosis (i.e. H2 S oral halitosis, assessed both objectively and subjectively. With regular rinsing, the effect was sustained for 6 months. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  9. 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

  10. 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

  11. [Contribution of the study of singing in tune in musically non-expert subjects: importance of short term memory of the pitch (19 to 28 year-old subjects)].

    Science.gov (United States)

    Belin, S; Peuvergne, A; Sarfati, J

    2005-01-01

    In the singing, which requires precise knowledge of the relevant musical code in use, accuracy of intonation plays a central role. Singing in tune requires to perceive pitch precisely and to memorize it before planning and executing the accurate vocal motion, which allows the exact emission of the correct pitch. Our work investigated the role of short term memory of pitch on singing accuracy. For that purpose, the experimental protocol of Deutsch (1970) was adapted for a perception and a production task. Participants were selected for their singing accuracy and separated into two groups of ten singing in tune and ten out-of-tune. All participants perceived pitch height exactly and were musically non-experts. For the perception and the production tasks, participants had to either compare or reproduce single pitches or two-pitch-sets. For the perception task, participants had to compare either single pitches or two-pitch patterns, all separated by a five seconds delay. For the production task, participants had to reproduce either single pitches or two-pitch patterns after a five seconds delay. The five seconds delay was either filled with intervening numbers, or with intervening tones, or without any disturbing sound. In perception and production task, the presence of intervening tones disturbs deeply the success of the subjects for every trial. Performance of the in-tune singing group is better for all the exercises while the other group had difficulties on single pitches and two-pitch patterns and was more disturbed by the effect of the intervening material. The outcome suggests that short term memory of pitch and accuracy of intonation would be closely linked. Further research needs to specify if that would mean that troubles in singing in tune are a consequence of a low-efficient short term memory of pitch, or if that troubles would hold up the right construction of the short term memory of pitch.

  12. 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

  13. 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.

  14. 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.

  15. 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.

  16. Cognitive stimulation in cognitively impaired individuals and cognitively healthy individuals with a family history of dementia: short-term results from the "Allena-Mente" randomized controlled trial.

    Science.gov (United States)

    Polito, Letizia; Abbondanza, Simona; Vaccaro, Roberta; Valle, Eleonora; Davin, Annalisa; Degrate, Alessandro; Villani, Simona; Guaita, Antonio

    2015-06-01

    We evaluated the short-term efficacy of a protocol of cognitive stimulation (CS), compared with a sham intervention, on cognitive performance in cognitively healthy individuals with a family history of dementia (NDFAM) and in non-demented individuals with cognitive impairment (CI). We performed a randomized controlled trial of CS in NDFAM and CI. CS consisted in 10 twice weekly meetings of CS focused on a specific cognitive area. CS was compared with a sham intervention (CT) using Mini-mental state examination (MMSE), Montreal Cognitive Assessment (MoCA), and the Corsi test. All study participants were typed for the presence of apolipoprotein E (APOE)-Ɛ4. Cognitively healthy NDFAM showed a higher net cognitive gain after CS, as reflected in their MoCA score, and a borderline significant net increase in visuospatial memory (Corsi test) compared with those receiving the CT. APOE-Ɛ4 carriers showed a less significant improvement on the Corsi test with respect to APOE-Ɛ4 non-carriers. In the CI sample, the MoCA and Corsi test results did not differ between the cognitively stimulated subjects and the controls. No changes in MMSE scores were found in either sample of subjects. These findings suggest that CS as structured in this study is an effective treatment in cognitively healthy individuals, whereas it is less effective in individuals with CI. Moreover, evaluation of APOE-Ɛ4 status provided evidence of a substantial genetic contribution to the efficacy of CS on visuospatial memory as measured using the Corsi test. Copyright © 2014 John Wiley & Sons, Ltd.

  17. Interventions Supporting Long-term Adherence aNd Decreasing cardiovascular events (ISLAND): Pragmatic randomized trial protocol.

    Science.gov (United States)

    Ivers, Noah; Schwalm, J-D; Witteman, Holly O; Presseau, Justin; Taljaard, Monica; McCready, Tara; Bosiak, Beth; Cunningham, Jennifer; Smarz, Shelley; Desveaux, Laura; Tu, Jack V; Atzema, Clare; Oakes, Garth; Isaranuwatchai, Wanrudee; Grace, Sherry L; Bhatia, R Sacha; Natarajan, Madhu; Grimshaw, Jeremy M

    2017-08-01

    Guidelines recommend cardiac rehabilitation and long-term use of cardiac medications for most patients who have had a myocardial infarction (MI), but adherence to these secondary prevention treatments is suboptimal. This is a multicenter, pragmatic, 3-arm randomized trial. Eligible patients (n = 2,742) with obstructive coronary artery disease are randomized post-MI to usual care or 1 of 2 intervention arms. Patients in the first intervention arm receive mail-outs sent on behalf of their cardiologist at 4, 8, 20, 32, and 44 weeks post-MI; content is designed to address determinants of adherence and facilitate discussion between the patient and their health care team. Patients in the second intervention arm receive mail-outs plus automated interactive voice response system telephone calls 2 weeks after each letter, as well as a telephone call by trained lay health workers if the interactive voice response system identifies challenges with adherence. Outcomes are assessed 12 months post-MI via patient self-report and administrative data sources. Co-primary outcomes are adherence to cardiac medications and completion of cardiac rehabilitation. Secondary outcomes include cardiovascular events and mortality. An embedded, theory-informed process evaluation will explore the mechanism of action; an economic evaluation is also planned. We describe a complete program evaluation of a highly pragmatic, health-system intervention to support adherence to recommended treatments. Research ethics boards approved waiver of consent for patients enrolled in the trial with provision of multiple opportunities to opt out and a debrief at the time of outcome assessment. The methods used here may provide a model for similar interventions. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Nasopharyngeal carriage and macrolide resistance in Indigenous children with bronchiectasis randomized to long-term azithromycin or placebo.

    Science.gov (United States)

    Hare, K M; Grimwood, K; Chang, A B; Chatfield, M D; Valery, P C; Leach, A J; Smith-Vaughan, H C; Morris, P S; Byrnes, C A; Torzillo, P J; Cheng, A C

    2015-11-01

    Although long-term azithromycin decreases exacerbation frequency in bronchiectasis, increased macrolide resistance is concerning. We investigated macrolide resistance determinants in a secondary analysis of a multicenter randomized controlled trial. Indigenous Australian children living in remote regions and urban New Zealand Māori and Pacific Islander children with bronchiectasis were randomized to weekly azithromycin (30 mg/kg) or placebo for up to 24 months and followed post-intervention for up to 12 months. Nurses administered and recorded medications given and collected nasopharyngeal swabs 3-6 monthly for culture and antimicrobial susceptibility testing. Nasopharyngeal carriage of Haemophilus influenzae and Moraxella catarrhalis was significantly lower in azithromycin compared to placebo groups, while macrolide-resistant Streptococcus pneumoniae and Staphylococcus aureus carriage was significantly higher. Australian children, compared to New Zealand children, had higher carriage overall, significantly higher carriage of macrolide-resistant bacteria at baseline (16/38 versus 2/40 children) and during the intervention (69/152 versus 22/239 swabs), and lower mean adherence to study medication (63 % versus 92 %). Adherence ≥70 % (versus azithromycin group was associated with lower carriage of any pathogen [odds ratio (OR) 0.19, 95 % confidence interval (CI) 0.07-0.53] and fewer macrolide-resistant pathogens (OR 0.34, 95 % CI 0.14-0.81). Post-intervention (median 6 months), macrolide resistance in S. pneumoniae declined significantly in the azithromycin group, from 79 % (11/14) to 7 % (1/14) of positive swabs, but S. aureus strains remained 100 % macrolide resistant. Azithromycin treatment, the Australian remote setting, and adherence <70 % were significant independent determinants of macrolide resistance in children with bronchiectasis. Adherence to treatment may limit macrolide resistance by suppressing carriage.

  19. A pilot randomized crossover trial assessing the safety and short-term effects of pomegranate supplementation in hemodialysis patients.

    Science.gov (United States)

    Rivara, Matthew B; Mehrotra, Rajnish; Linke, Lori; Ruzinski, John; Ikizler, T Alp; Himmelfarb, Jonathan

    2015-01-01

    Oxidative stress and systemic inflammation are highly prevalent in patients undergoing maintenance hemodialysis (MHD) and are linked to excess cardiovascular risk. This study examined whether short-term supplementation with pomegranate juice and extract is safe and well tolerated by MHD patients. The secondary aim was to assess the effect of pomegranate supplementation on oxidative stress, systemic inflammation, monocyte function, and blood pressure. Prospective, randomized, crossover, pilot clinical trial (NCT01562340). The study was conducted from March to October 2012 in outpatient dialysis facilities in the Seattle metropolitan area. Twenty-four patients undergoing MHD (men, 64%; mean age, 61 ± 14 years) were randomly assigned to receive pomegranate juice or extract during a 4-week intervention period. After a washout period, all patients received the alternative treatment during a second 4-week intervention period. Patients assigned to receive pomegranate juice received 100 mL of juice before each dialysis session. Patients assigned to receive pomegranate extract were given 1,050 mg of extract daily. The main outcome measures were safety and tolerability of pomegranate juice and extract. Additional secondary outcomes assessed included serum lipids, laboratory biomarkers of inflammation (C-reactive protein and interleukin 6) and oxidative stress (plasma F2 isoprostanes and isofurans), monocyte cytokine production, and predialysis blood pressure. Both pomegranate juice and extract were safe and well tolerated by study participants. Over the study period, neither treatment had a significant effect on lipid profiles, plasma C-reactive protein, interleukin 6, F2-isoprostane or isofuran concentrations, predialysis systolic or diastolic blood pressure nor changed the levels of monocyte cytokine production. Both pomegranate juice and extract are safe and well tolerated by patients undergoing MHD but do not influence markers of inflammation or oxidative stress

  20. A randomized, controlled trial to assess short-term black pepper consumption on 24-hour energy expenditure and substrate utilization

    Directory of Open Access Journals (Sweden)

    Annalouise O’Connor

    2013-10-01

    Full Text Available ABSTRACTBackground: Thermogenic ingredients may play a role in weight management. In vitro and rodent work suggests that components of black pepper may impact energy expenditure, and in humans, other TPRV1 agonists e.g. capsaicin, augment EE. Objectives: To determine the impact of BP on 24-hour EE, respiratory quotient, and biochemical markers of metabolism and satiety, a randomized, controlled, cross-over study of black pepper (0.5mg/meal versus no pepper control was conducted in post-menopausal women. Subjects spent two 24-hour periods in a whole room indirect calorimeter. Results: Post-meal glucose, insulin, gut peptides and catecholamines were measured. Energy expenditure, respiratory quotient, or biochemical markers assessed did not differ significantly between the black pepper and no pepper control study days. Conclusions: Our findings do not support a role for black pepper in modulating energy expenditure in overweight postmenopausal women. Future work targeting alternative populations, administering black pepper in the fasted state, or in combination with other spices, may reveal the thermogenic effect of this spice.Trial registration: This trial was registered at clinicaltrials.gov (NCT01729143.Key words: Black pepper, piperine, energy expenditure, metabolic chamber

  1. Comparative randomized open-label trial on efficacy and safety of Persen® and Persen® Night herbal extracts in patients with short-term insomnia

    Directory of Open Access Journals (Sweden)

    A. P. Rachin

    2016-01-01

    Full Text Available Herbal sedatives serve an alternative to antipsychotics and hypnotics aimed to alleviate symptoms of anxious disorders and insomnia. Valeriana officinalis L., Mentha piperita L. and Melissa officinalis are most widely used in neurology as sedatives of herbal origin. We present the results of a randomized open-label trial on efficiency and safety of Persen® and Persen® Night containing extracts of the above mentioned plants in patients with short-term insomnia. The study consisted of 60 subjects of 18–65 y.o. (mean 42.4 ± 6.9 y.o. with short-term insomnia due to adjustment disorder or mixed anxiety-depressive disorders: 30 of them got Persen® 2 tablets a day and 30 – Persen® Night, 1 capsule 30–60 min before sleep during 4 weeks. The majority (76.5 % of patients referred the onset of insomnia with psychosocial traumatic stressor. Persen® Night’s main action was found on superficial sleep, number of night awakenings, sleep onset rate. At the end of the therapy with this substance 39.7 % of patients fell asleep in 10–15 min, and 92.2 % – in 30 min, accordingly, while for Persen® at 17.4 and 80.3 % accordingly (р < 0.05. In the meantime Persen® decreased the bad sleep perception at awakening and day somnolence, mostly attributed to the mood improvement and decrease of anxiety. Levels of efficacy and safety for both substances were significant, allowing to regard them as potential phytotherapeutic agent in the treatment of insomnia and mixed anxiety-depressive disorders.

  2. Prospective randomized trial of transthoracic versus low-energy internal cardioversion in persistent atrial fibrillation: long term follow-up.

    Science.gov (United States)

    Ozdemir, Murat; Türkoglu, Sedat; Kaya, Mehmet Güngör; Cengel, Atiye

    2006-09-01

    Low energy internal cardioversion (ICV) is a relatively new method. This report describes the long-term follow-up results of a prospective randomized comparison of low energy ICV and transthoracic cardioversion (TT CV) in patients with persistent atrial fibrillation (AF). Fifty-two patients (mean age, 60.6 +/- 10.1 years, 23 males) with persistent AF were randomly assigned to either TT (n = 26) or ICV (n = 26). The baseline characteristics of the 2 groups were similar. Transthoracic CV was performed under sedation with hand-held electrodes in the apex-anterior position and high energy (100-360 J) monophasic shocks. ICV was performed by a dedicated balloon-directed catheter utilizing truncated, biphasic shocks of low energy (1-15 J). Sinus rhythm (SR) was restored in 24/26 (92%) patients in the ICV group and in 22/26 (85%) patients in the TT CV group (P > 0.05). Immediate recurrence of AF (IRAF), defined as reappearance of AF within 2 minutes of successful CV, occurred in 5 patients (21%) in the ICV group and in 1 patient (4.5%) in the TT group (P > 0.05). Successfully cardioverted patients in whom no IRAF occurred were followed-up for 18 months under both warfarin and Class 1 or 3 antiarrhythmic drugs, as guided by the current ACC/AHA/ESC Guidelines. The rate of SR at 1, 3, 6, 12, and 18 months of follow-up was not significantly different between the 2 groups, and in an intention-to-treat analysis at 18 months, SR was present in 6 patients (23%) in the ICV group and in 10 patients (38%) in the TT group (P > 0.05). The majority of AF recurrences occurred within a month of successful CV in both groups (8/12 [67%] in the TT group and 15/18 [83%] in the ICV group, P > 0.05). The mortality, thromboembolic, and bleeding complication rates were similar in the 2 groups. In this prospective randomized comparison of TT and low energy ICV in patients with persistent AF, the 18-month rates of SR and major adverse clinical events were found to be similar.

  3. Management of women with human papillomavirus persistence: long-term follow-up of a randomized clinical trial.

    Science.gov (United States)

    Elfgren, Kristina; Elfström, K Miriam; Naucler, Pontus; Arnheim-Dahlström, Lisen; Dillner, Joakim

    2017-03-01

    Introduction of human papillomavirus-based screening is ongoing in many countries, given its higher sensitivity and longer-lasting protection compared with cytology-based screening. However, optimal clinical management of human papillomavirus-positive but cytology-negative women is unclear, and additional studies with clinical follow-up are warranted. The aim of the current study was to investigate the long-term outcomes of the clinical management used in a double-blind, randomized clinical trial of human papillomavirus screening conducted in the context of the routine, organized screening program in Sweden. Among 12,527 women aged 32-38 years enrolled in the trial, we followed up the 195 women who attended the colposcopy screening who were cytologically normal but persistently human papillomavirus positive (at least 12 months later; median, 19 months) in the human papillomavirus testing arm (n = 100) or were randomly selected from the control arm (n = 95). Women in the human papillomavirus testing arm were followed up with repeated human papillomavirus testing, cytologies, and colposcopies if persistently human papillomavirus-positive without cervical intraepithelial neoplasia grade 2 or worse. A similar number of random colposcopies and tests were carried out in the control arm. Women were followed up over 13 years for the main outcome measures: cumulative incidence of cervical intraepithelial neoplasia grade 2 or worse and cervical intraepithelial neoplasia grade 3 or worse. Among women who continued to attend and had continuous human papillomavirus persistence, all (40 of 40, 100% [95% confidence interval, 91-100%]) developed cervical intraepithelial neoplasia grade 2 or worse. There were no cases among women who cleared their human papillomavirus persistence (0 of 35, 0% (95% confidence interval, 0-10%) (P < .001). Among women who had had human papillomavirus persistence but did not continue with repeated human papillomavirus tests (unknown persistence

  4. 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

  5. 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.

  6. 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

  7. Treatment outcome and long-term stability of skeletal changes following maxillary distraction in adult subjects of cleft lip and palate

    Directory of Open Access Journals (Sweden)

    Satinder Pal Singh

    2012-01-01

    Full Text Available Aim : To evaluate the treatment outcome and long-term stability of skeletal changes following maxillary advancement with distraction osteogenesis in adult subjects of cleft lip and palate. Materials and Methods: Total 12 North Indian adult patients in the age range of 17-34 years with cleft lip and palate underwent advancement of maxilla by distraction osteogenesis. Lateral cephalograms recorded prior to distraction, at the end of distraction, 6 months after distraction, and at least 24 months (mean 25.5 ± 1.94 months after distraction osteogenesis were used for the evaluation of treatment outcome and long-term stability of the skeletal changes. Descriptive analysis, ANOVA, and post-hoc test were used, and P-value 0.05 was considered as a statistically significant level. Results: Maxillary distraction resulted in significant advancement of maxilla (P<0.001. Counterclockwise rotation of the palatal plane took place after maxillary distraction. The position of the mandible and facial heights were stable during distraction. During the first 6 months of the post-distraction period, the maxilla showed relapse of approximately 30%. However, after 6 months post distraction, the relapse was very negligible. Conclusions: Successful advancement of maxilla was achieved by distraction osteogenesis in adult subjects with cleft lip and palate. Most of the relapse occurred during the first 6 months of post-distraction period, and after that the outcomes were stable.

  8. Treatment outcome and long-term stability of skeletal changes following maxillary distraction in adult subjects of cleft lip and palate.

    Science.gov (United States)

    Singh, Satinder Pal; Jena, Ashok Kumar; Rattan, Vidya; Utreja, Ashok Kumar

    2012-04-01

    To evaluate the treatment outcome and long-term stability of skeletal changes following maxillary advancement with distraction osteogenesis in adult subjects of cleft lip and palate. Total 12 North Indian adult patients in the age range of 17-34 years with cleft lip and palate underwent advancement of maxilla by distraction osteogenesis. Lateral cephalograms recorded prior to distraction, at the end of distraction, 6 months after distraction, and at least 24 months (mean 25.5 ± 1.94 months) after distraction osteogenesis were used for the evaluation of treatment outcome and long-term stability of the skeletal changes. Descriptive analysis, ANOVA, and post-hoc test were used, and P-value 0.05 was considered as a statistically significant level. Maxillary distraction resulted in significant advancement of maxilla (Ppalatal plane took place after maxillary distraction. The position of the mandible and facial heights were stable during distraction. During the first 6 months of the post-distraction period, the maxilla showed relapse of approximately 30%. However, after 6 months post distraction, the relapse was very negligible. Successful advancement of maxilla was achieved by distraction osteogenesis in adult subjects with cleft lip and palate. Most of the relapse occurred during the first 6 months of post-distraction period, and after that the outcomes were stable.

  9. The long-term outcomes of interventions for the management of attention-deficit hyperactivity disorder in children and adolescents: a systematic review of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Parker J

    2013-09-01

    Full Text Available Jack Parker,1 Gill Wales,2 Nevyne Chalhoub,1 Val Harpin2 1Child and Adolescent Mental Health Service, Sheffield Children’s NHS Foundation Trust, Sheffield, UK; 2Paediatric Neurodisability, Ryegate Children’s Centre, Sheffield Children’s NHS Foundation Trust, Sheffield, UK Purpose: To systematically identify and review the currently available evidence on the long-term outcomes of recommended attention-deficit hyperactivity disorder (ADHD interventions following randomized controlled trials with children and young people. Method: A systematic search was conducted to identify trials >1 year in length using the following databases: CINAHL (January 1982– July 2012, MEDLINE (Ovid and Cambridge Scientific Abstracts [CSA], Psych info, Science Direct (Elsevier, and Cochrane Library. Hand searches of key journals in the subject, book chapters, and conference proceedings were also carried out. Relevant papers were critically appraised using the Cochrane risk of bias tool. Results: Eight controlled trials were identified as being relevant, of duration ranging from 1 year to 8 years (at follow up. The total number of participants in the studies was 1,057, of whom 579 (54.7% were from one cohort and included 26 different outcome measures. Results suggest there is moderate-to-high-level evidence that combined pharmacological and behavioral interventions, and pharmacological interventions alone can be effective in managing the core ADHD symptoms and academic performance at 14 months. However, the effect size may decrease beyond this period. Conclusion: This review has highlighted the paucity and limitations of the evidence investigating the long-term outcomes of recommended interventions for managing ADHD symptoms. There is little evidence to suggest that the effects observed over the relatively short term are maintained throughout longer periods of impairment. Furthermore, much of the existing evidence examining effectiveness beyond 12 months does not

  10. Impact of Sequencing Radiation Therapy and Chemotherapy on Long-Term Local Toxicity for Early Breast Cancer: Results of a Randomized Study at 15-Year Follow-Up

    Energy Technology Data Exchange (ETDEWEB)

    Pinnarò, Paola; Giordano, Carolina; Farneti, Alessia [Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome (Italy); Strigari, Lidia; Landoni, Valeria [Department of Physics, Regina Elena National Cancer Institute, Rome (Italy); Marucci, Laura; Petrongari, Maria Grazia [Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome (Italy); Sanguineti, Giuseppe, E-mail: sanguineti@ifo.it [Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome (Italy)

    2016-07-15

    Purpose: To compare long-term late local toxicity after either concomitant or sequential chemoradiation therapy after breast-conserving surgery. Methods and Materials: From 1997 to 2002, women aged 18 to 75 years who underwent breast-conserving surgery and axillary dissection for early breast cancer and in whom CMF (cyclophosphamide, methotrexate, and 5-fluorouracil) chemotherapy was planned were randomized between concomitant and sequential radiation therapy. Radiation therapy was delivered to the whole breast through tangential fields to 50 Gy in 20 fractions over a period of 4 weeks, followed by an electron boost. Surviving patients were tentatively contacted and examined between March and September 2014. Patients in whom progressive disease had developed or who had undergone further breast surgery were excluded. Local toxicity (fibrosis, telangiectasia, and breast atrophy or retraction) was scored blindly to the treatment received. A logistic regression was run to investigate the effect of treatment sequence after correction for several patient-, treatment-, and tumor-related covariates on selected endpoints. The median time to cross-sectional analysis was 15.7 years (range, 12.0-17.8 years). Results: Of 206 patients randomized, 154 (74.8%) were potentially eligible. Of these, 43 (27.9%) refused participation and 4 (2.6%) had been lost to follow-up, and for 5 (3.2%), we could not restore planning data; thus, the final number of analyzed patients was 102. No grade 4 toxicity had been observed, whereas the number of grade 3 toxicity events was low (<8%) for each item, allowing pooling of grade 2 and 3 events for further analysis. Treatment sequence (concomitant vs sequential) was an independent predictor of grade 2 or 3 fibrosis according to both the National Cancer Institute Common Terminology Criteria for Adverse Events (odds ratio [OR], 4.05; 95% confidence interval [CI], 1.34-12.2; P=.013) and the SOMA (Subjective, Objective, Management and Analytic

  11. Pragmatic randomized controlled trial of long-term psychoanalytic psychotherapy for treatment-resistant depression: the Tavistock Adult Depression Study (TADS).

    Science.gov (United States)

    Fonagy, Peter; Rost, Felicitas; Carlyle, Jo-Anne; McPherson, Susan; Thomas, Rachel; Pasco Fearon, R M; Goldberg, David; Taylor, David

    2015-10-01

    This pragmatic randomized controlled trial tested the effectiveness of long-term psychoanalytic psychotherapy (LTPP) as an adjunct to treatment-as-usual according to UK national guidelines (TAU), compared to TAU alone, in patients with long-standing major depression who had failed at least two different treatments and were considered to have treatment-resistant depression. Patients (N=129) were recruited from primary care and randomly allocated to the two treatment conditions. They were assessed at 6-monthly intervals during the 18 months of treatment and at 24, 30 and 42 months during follow-up. The primary outcome measure was the 17-item version of the Hamilton Depression Rating Scale (HDRS-17), with complete remission defined as a HDRS-17 score ≤8, and partial remission defined as a HDRS-17 score ≤12. Secondary outcome measures included self-reported depression as assessed by the Beck Depression Inventory - II, social functioning as evaluated by the Global Assessment of Functioning, subjective wellbeing as rated by the Clinical Outcomes in Routine Evaluation - Outcome Measure, and satisfaction with general activities as assessed by the Quality of Life Enjoyment and Satisfaction Questionnaire. Complete remission was infrequent in both groups at the end of treatment (9.4% in the LTPP group vs. 6.5% in the control group) as well as at 42-month follow-up (14.9% vs. 4.4%). Partial remission was not significantly more likely in the LTPP than in the control group at the end of treatment (32.1% vs. 23.9%, p=0.37), but significant differences emerged during follow-up (24 months: 38.8% vs. 19.2%, p=0.03; 30 months: 34.7% vs. 12.2%, p=0.008; 42 months: 30.0% vs. 4.4%, p=0.001). Both observer-based and self-reported depression scores showed steeper declines in the LTPP group, alongside greater improvements on measures of social adjustment. These data suggest that LTPP can be useful in improving the long-term outcome of treatment-resistant depression. End

  12. Long-term safety and efficacy of teriflunomide: Nine-year follow-up of the randomized TEMSO study.

    Science.gov (United States)

    O'Connor, Paul; Comi, Giancarlo; Freedman, Mark S; Miller, Aaron E; Kappos, Ludwig; Bouchard, Jean-Pierre; Lebrun-Frenay, Christine; Mares, Jan; Benamor, Myriam; Thangavelu, Karthinathan; Liang, Jinjun; Truffinet, Philippe; Lawson, Victoria J; Wolinsky, Jerry S

    2016-03-08

    To report safety and efficacy outcomes from up to 9 years of treatment with teriflunomide in an extension (NCT00803049) of the pivotal phase 3 Teriflunomide Multiple Sclerosis Oral (TEMSO) trial (NCT00134563). A total of 742 patients entered the extension. Teriflunomide-treated patients continued the original dose; those previously receiving placebo were randomized 1:1 to teriflunomide 14 mg or 7 mg. By June 2013, median (maximum) teriflunomide exposure exceeded 190 (325) weeks per patient; 468 patients (63%) remained on treatment. Teriflunomide was well-tolerated with continued exposure. The most common adverse events (AEs) matched those in the core study. In extension year 1, first AEs of transient liver enzyme increases or reversible hair thinning were generally attributable to patients switching from placebo to teriflunomide. Approximately 11% of patients discontinued treatment owing to AEs. Twenty percent of patients experienced serious AEs. There were 3 deaths unrelated to teriflunomide. Soon after the extension started, annualized relapse rates and gadolinium-enhancing T1 lesion counts fell in patients switching from placebo to teriflunomide, remaining low thereafter. Disability remained stable in all treatment groups (median Expanded Disability Status Scale score ≤2.5; probability of 12-week disability progression ≤0.48). In the TEMSO extension, safety observations were consistent with the core trial, with no new or unexpected AEs in patients receiving teriflunomide for up to 9 years. Disease activity decreased in patients switching from placebo and remained low in patients continuing on teriflunomide. This study provides Class III evidence that long-term treatment with teriflunomide is well-tolerated and efficacy of teriflunomide is maintained long-term. © 2016 American Academy of Neurology.

  13. The Impact of Short-Term Video Games on Performance among Children with Developmental Delays: A Randomized Controlled Trial.

    Science.gov (United States)

    Hsieh, Ru-Lan; Lee, Wen-Chung; Lin, Jui-Hsiang

    2016-01-01

    This prospective, randomized controlled study investigated the effects of short-term interactive video game playing among children with developmental delays participating in traditional rehabilitation treatment at a rehabilitation clinic. One hundred and one boys and 46 girls with a mean age of 5.8 years (range: 3 to 12 years) were enrolled in this study. All patients were confirmed to suffer from developmental delays, and were participating in traditional rehabilitation treatment. Children participated in two periods of 4 weeks each, group A being offered intervention of eight 30-minute sessions of interactive video games in the first period, and group B in the second, in addition to the traditional rehabilitation treatment. The physical, psychosocial, and total health of the children was periodically assessed using the parent-reported Pediatric Quality of Life Inventory-Generic Core Scales (PedsQL); and the children's upper extremity and physical function, transfer and basic mobility, sports and physical functioning, and global functioning were assessed using the Pediatric Outcomes Data Collection Instrument. Parental impact was evaluated using the PedsQL-Family Impact Module for family function, PedsQL-Health Satisfaction questionnaire for parents' satisfaction with their children's care and World Health Organization-Quality of Life-Brief Version for quality of life. Compared with the baseline, significant improvements of physical function were observed in both groups (5.6 ± 19.5, p = 0.013; 4.7 ± 13.8, p = 0.009) during the intervention periods. No significant improvement of psychosocial health, functional performance, or family impact was observed in children with developmental delays. Short-term interactive video game play in conjunction with traditional rehabilitation treatment improved the physical health of children with developmental delays. ClinicalTrials.gov NCT02184715.

  14. The Impact of Short-Term Video Games on Performance among Children with Developmental Delays: A Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Ru-Lan Hsieh

    Full Text Available This prospective, randomized controlled study investigated the effects of short-term interactive video game playing among children with developmental delays participating in traditional rehabilitation treatment at a rehabilitation clinic. One hundred and one boys and 46 girls with a mean age of 5.8 years (range: 3 to 12 years were enrolled in this study. All patients were confirmed to suffer from developmental delays, and were participating in traditional rehabilitation treatment. Children participated in two periods of 4 weeks each, group A being offered intervention of eight 30-minute sessions of interactive video games in the first period, and group B in the second, in addition to the traditional rehabilitation treatment. The physical, psychosocial, and total health of the children was periodically assessed using the parent-reported Pediatric Quality of Life Inventory-Generic Core Scales (PedsQL; and the children's upper extremity and physical function, transfer and basic mobility, sports and physical functioning, and global functioning were assessed using the Pediatric Outcomes Data Collection Instrument. Parental impact was evaluated using the PedsQL-Family Impact Module for family function, PedsQL-Health Satisfaction questionnaire for parents' satisfaction with their children's care and World Health Organization-Quality of Life-Brief Version for quality of life. Compared with the baseline, significant improvements of physical function were observed in both groups (5.6 ± 19.5, p = 0.013; 4.7 ± 13.8, p = 0.009 during the intervention periods. No significant improvement of psychosocial health, functional performance, or family impact was observed in children with developmental delays. Short-term interactive video game play in conjunction with traditional rehabilitation treatment improved the physical health of children with developmental delays.ClinicalTrials.gov NCT02184715.

  15. [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

  16. Long-Term Monitoring of Physical Behavior Reveals Different Cardiac Responses to Physical Activity among Subjects with and without Chronic Neck Pain

    Directory of Open Access Journals (Sweden)

    David M. Hallman

    2015-01-01

    Full Text Available Background. We determined the extent to which heart rate variability (HRV responses to daily physical activity differ between subjects with and without chronic neck pain. Method. Twenty-nine subjects (13 women with chronic neck pain and 27 age- and gender-matched healthy controls participated. Physical activity (accelerometry, HRV (heart rate monitor, and spatial location (Global Positioning System (GPS were recorded for 74 hours. GPS data were combined with a diary to identify periods of work and of leisure at home and elsewhere. Time- and frequency-domain HRV indices were calculated and stratified by period and activity type (lying/sitting, standing, or walking. ANCOVAs with multiple adjustments were used to disclose possible group differences in HRV. Results. The pain group showed a reduced HRV response to physical activity compared with controls (p=.001, according to the sympathetic-baroreceptor HRV index (LF/HF, ratio between low- and high-frequency power, even after adjustment for leisure time physical activity, work stress, sleep quality, mental health, and aerobic capacity (p=.02. The parasympathetic response to physical activity did not differ between groups. Conclusions. Relying on long-term monitoring of physical behavior and heart rate variability, we found an aberrant sympathetic-baroreceptor response to daily physical activity among subjects with chronic neck pain.

  17. Long-term Safety and Efficacy of Latanoprostene Bunod 0.024% in Japanese Subjects with Open-Angle Glaucoma or Ocular Hypertension: The JUPITER Study.

    Science.gov (United States)

    Kawase, Kazuhide; Vittitow, Jason L; Weinreb, Robert N; Araie, Makoto

    2016-09-01

    Latanoprostene bunod (LBN) is a novel nitric oxide (NO)-donating prostaglandin F2α analog. We evaluated the long-term safety and intraocular pressure (IOP)-lowering efficacy of LBN ophthalmic solution 0.024% over 1 year in Japanese subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT). This was a single-arm, multicenter, open-label, clinical study. Subjects aged 20 years and older with a diagnosis of OAG or OHT instilled 1 drop of LBN ophthalmic solution 0.024% in the affected eye(s) once daily in the evening for 52 weeks and were evaluated every 4 weeks. Safety assessments included vital signs, comprehensive ophthalmic exams, and treatment-emergent adverse events (AEs). Absolute and percent reductions from baseline in IOP were also determined. Of 130 subjects enrolled, 121 (93.1%) completed the study. Mean age was 62.5 years, and mean (standard deviation) baseline IOP was 19.6 (2.9) and 18.7 (2.6) mmHg in study eyes and treated fellow eyes, respectively. Overall, 76/130 (58.5%) and 78/126 (61.9%) subjects experienced ≥1 AEs in study eyes and treated fellow eyes, respectively. In both study eyes and treated fellow eyes, the most common AEs were conjunctival hyperemia, growth of eyelashes, eye irritation, and eye pain. At 52 weeks, 9% of treated eyes had an increase in iris pigmentation compared with baseline based on iris photographs. No safety concerns emerged based on vital signs or other ocular assessments. Mean reductions from baseline in IOP of 22.0% and 19.5% were achieved by week 4 in study and treated fellow eyes, respectively. These reductions were maintained through week 52 (P < 0.001 vs. baseline at all visits). Once daily LBN ophthalmic solution 0.024% was safe and well-tolerated in Japanese subjects with OAG or OHT when used for up to 1 year. Long-term treatment with LBN ophthalmic solution 0.024% provided significant and sustained IOP reduction. ClinicalTrials.gov identifier, NCT01895972. Bausch & Lomb, Inc. a division of

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. Power Spectral Analysis of Short-Term Heart Rate Variability in Healthy and Arrhythmia Subjects by the Adaptive Continuous Morlet Wavelet Transform

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    Ram Sewak SINGH

    2017-12-01

    Full Text Available Power spectral analysis of short-term heart rate variability (HRV can provide instant valuable information to understand the functioning of autonomic control over the cardiovascular system. In this study, an adaptive continuous Morlet wavelet transform (ACMWT method has been used to describe the time-frequency characteristics of the HRV using band power spectra and the median value of interquartile range. Adaptation of the method was based on the measurement of maximum energy concentration. The ACMWT has been validated on synthetic signals (i.e. stationary, non-stationary as slow varying and fast changing frequency with time modeled as closest to dynamic changes in HRV signals. This method has been also tested in the presence of additive white Gaussian noise (AWGN to show its robustness towards the noise. From the results of testing on synthetic signals, the ACMWT was found to be an enhanced energy concentration estimator for assessment of power spectral of short-term HRV time series compared to adaptive Stockwell transform (AST, adaptive modified Stockwell transform (AMST, standard continuous Morlet wavelet transform (CMWT and Stockwell transform (ST estimators at statistical significance level of 5%. Further, the ACMWT was applied to real HRV data from Fantasia and MIT-BIH databases, grouped as healthy young group (HYG, healthy elderly group (HEG, arrhythmia controlled medication group (ARCMG, and supraventricular tachycardia group (SVTG subjects. The global results demonstrate that spectral indices of low frequency power (LFp and high frequency power (HFp of HRV were decreased in HEG compared to HYG subjects (p<0.0001. While LFp and HFp indices were increased in ARCMG compared to HEG (p<0.00001. The LFp and HFp components of HRV obtained from SVTG were reduced compared to other group subjects (p<0.00001.

  3. Gastric bypass surgery is followed by lowered blood pressure and increased diuresis - long term results from the Swedish Obese Subjects (SOS study.

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    Peter Hallersund

    Full Text Available OBJECTIVE: To compare two bariatric surgical principles with regard to effects on blood pressure and salt intake. BACKGROUND: In most patients bariatric surgery induces a sustained weight loss and a reduced cardiovascular risk profile but the long-term effect on blood pressure is uncertain. METHODS: Cohort study with data from the prospective, controlled Swedish Obese Subjects (SOS study involving 480 primary health care centres and 25 surgical departments in Sweden. Obese patients treated with non-surgical methods (Controls, n = 1636 and n = 1132 at 2 y and 10 y follow up, respectively were compared to patients treated with gastric bypass (GBP, n = 245 and n = 277, respectively or purely restrictive procedures (vertical banded gastroplasty or gastric banding; VBG/B, n = 1534 and n = 1064, respectively. RESULTS: At long-term follow-up (median 10 y GBP was associated with lowered systolic (mean: -5.1 mm Hg and diastolic pressure (-5.6 mmHg differing significantly from both VBG/B (-1.5 and -2.1 mmHg, respectively; p<0.001 and Controls (+1.2 and -3.8 mmHg, respectively; p<0.01. Diurnal urinary output was +100 ml (P<0.05 and +170 ml (P<0.001 higher in GBP subjects than in weight-loss matched VBG/B subjects at the 2 y and 10 y follow-ups, respectively. Urinary output was linearly associated with blood pressure only after GBP and these patients consumed approximately 1 g salt per day more at the follow-ups than did VBG/B (P<0.01. CONCLUSIONS: The purely restrictive techniques VBG/B exerted a transient blood pressure lowering effect, whereas gastric bypass was associated with a sustained blood pressure reduction and an increased diuresis. The daily salt consumption was higher after gastric bypass than after restrictive bariatric surgery.

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

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    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. 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

  6. 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

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

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    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.

  8. Bidirectional Long Short-Term Memory Network with a Conditional Random Field Layer for Uyghur Part-Of-Speech Tagging

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    Maihemuti Maimaiti

    2017-11-01

    Full Text Available Uyghur is an agglutinative and a morphologically rich language; natural language processing tasks in Uyghur can be a challenge. Word morphology is important in Uyghur part-of-speech (POS tagging. However, POS tagging performance suffers from error propagation of morphological analyzers. To address this problem, we propose a few models for POS tagging: conditional random fields (CRF, long short-term memory (LSTM, bidirectional LSTM networks (BI-LSTM, LSTM networks with a CRF layer, and BI-LSTM networks with a CRF layer. These models do not depend on stemming and word disambiguation for Uyghur and combine hand-crafted features with neural network models. State-of-the-art performance on Uyghur POS tagging is achieved on test data sets using the proposed approach: 98.41% accuracy on 15 labels and 95.74% accuracy on 64 labels, which are 2.71% and 4% improvements, respectively, over the CRF model results. Using engineered features, our model achieves further improvements of 0.2% (15 labels and 0.48% (64 labels. The results indicate that the proposed method could be an effective approach for POS tagging in other morphologically rich languages.

  9. A Permutation Importance-Based Feature Selection Method for Short-Term Electricity Load Forecasting Using Random Forest

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    Nantian Huang

    2016-09-01

    Full Text Available The prediction accuracy of short-term load forecast (STLF depends on prediction model choice and feature selection result. In this paper, a novel random forest (RF-based feature selection method for STLF is proposed. First, 243 related features were extracted from historical load data and the time information of prediction points to form the original feature set. Subsequently, the original feature set was used to train an RF as the original model. After the training process, the prediction error of the original model on the test set was recorded and the permutation importance (PI value of each feature was obtained. Then, an improved sequential backward search method was used to select the optimal forecasting feature subset based on the PI value of each feature. Finally, the optimal forecasting feature subset was used to train a new RF model as the final prediction model. Experiments showed that the prediction accuracy of RF trained by the optimal forecasting feature subset was higher than that of the original model and comparative models based on support vector regression and artificial neural network.

  10. Long-term effects of the Mediterranean lifestyle program: a randomized clinical trial for postmenopausal women with type 2 diabetes

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    Ritzwoller Debra P

    2007-01-01

    Full Text Available Abstract Background Multiple-risk-factor interventions offer a promising means for addressing the complex interactions between lifestyle behaviors, psychosocial factors, and the social environment. This report examines the long-term effects of a multiple-risk-factor intervention. Methods Postmenopausal women (N = 279 with type 2 diabetes participated in the Mediterranean Lifestyle Program (MLP, a randomized, comprehensive lifestyle intervention study. The intervention targeted healthful eating, physical activity, stress management, smoking cessation, and social support. Outcomes included lifestyle behaviors (i.e., dietary intake, physical activity, stress management, smoking cessation, psychosocial variables (e.g., social support, problem solving, self-efficacy, depression, quality of life, and cost analyses at baseline, and 6, 12, and 24 months. Results MLP participants showed significant 12- and 24-month improvements in all targeted lifestyle behaviors with one exception (there were too few smokers to analyze tobacco use effects, and in psychosocial measures of use of supportive resources, problem solving, self-efficacy, and quality of life. Conclusion The MLP was more effective than usual care over 24 months in producing improvements on behavioral and psychosocial outcomes. Directions for future research include replication with other populations.

  11. Long-term effects of a home-based smoking prevention program on smoking initiation: a cluster randomized controlled trial.

    Science.gov (United States)

    Hiemstra, Marieke; Ringlever, Linda; Otten, Roy; van Schayck, Onno C P; Jackson, Christine; Engels, Rutger C M E

    2014-03-01

    The aims of the study were to evaluate the long-term effects of a home-based smoking prevention program 'Smoke-free Kids' during preadolescence on smoking initiation during adolescence and to test the potential moderating role of parental smoking, socioeconomic status, and asthma. In 2008, 1478 9-11year old children and their mothers were recruited from 418 elementary schools in the Netherlands. An independent statistician randomly allocated schools to one of the two conditions using a 1:1 ratio (single blind): 728 children in the intervention and 750 in the control condition. The intervention condition received five activity modules, including a communication sheet for mothers, by mail at four-week intervals and one booster module one year after baseline. The control condition received a fact-based intervention only. Intention-to-treat analysis was performed on 1398 non-smoking children at baseline. In the intervention 10.8% of the children started smoking compared to 12% in the control condition. This difference was non-significant (odds ratio=0.90, 95% confidence interval=0.63-1.27). No moderating effects were found. No effects on smoking initiation after 36months were found. Perhaps, the program was implemented with children that were too young. Programs closer to the age of smoking onset should be tested. Copyright © 2013 Elsevier Inc. All rights reserved.

  12. Subjective and objective peer approval evaluations and self-esteem development: A test of reciprocal, prospective, and long-term effects.

    Science.gov (United States)

    Gruenenfelder-Steiger, Andrea E; Harris, Michelle A; Fend, Helmut A

    2016-10-01

    A large body of literature suggests a clear, concurrent association between peer approval and self-esteem in adolescence. However, little empirical work exists on either the prospective or reciprocal relation between peer approval and self-esteem during this age period. Moreover, it is unclear from past research whether both subjectively perceived peer approval and objectively measured peer approval are related to subsequent self-esteem over time (and vice versa) and whether these paths have long-term associations into adulthood. Using data from a large longitudinal study that covers a time span of 2 decades, we examined reciprocal, prospective relations between self-esteem and peer approval during ages 12-16 in addition to long-term relations between these variables and later social constructs at age 35. Cross-lagged regression analyses revealed small but persistent effect sizes from both types of peer approval to subsequent self-esteem in adolescence, controlling for prior self-esteem. However, effects in the reverse direction were not confirmed. These findings support the notion that peer relationships serve an important function for later self-esteem, consistent with many theoretical tenets of the importance of peers for building a strong identity. Finally, we found long-term relations between adult social constructs and adolescent objective and subjective peer approval as well as self-esteem. Therefore, not only do peer relationships play a role in self-esteem development across adolescence, but they remain impactful throughout adulthood. In sum, the current findings highlight the lasting, yet small link between peer relationships and self-esteem development and call for investigations of further influential factors for self-esteem over time. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

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

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    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.

  14. 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.

  15. 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.

  16. 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.

  17. Experiences of a long-term randomized controlled prevention trial in a maiden environment: Estonian Postmenopausal Hormone Therapy trial

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    Rahu Mati

    2008-08-01

    Full Text Available Abstract Background Preventive drugs require long-term trials to show their effectiveness or harms and often a lot of changes occur during post-marketing studies. The purpose of this article is to describe the research process in a long-term randomized controlled trial and discuss the impact and consequences of changes in the research environment. Methods The Estonian Postmenopausal Hormone Therapy trial (EPHT, originally planned to continue for five years, was planned in co-operation with the Women's International Study of Long-Duration Oestrogen after Menopause (WISDOM in the UK. In addition to health outcomes, EPHT was specifically designed to study the impact of postmenopausal hormone therapy (HT on health services utilization. Results After EPHT recruited in 1999–2001 the Women's Health Initiative (WHI in the USA decided to stop the estrogen-progestin trial after a mean of 5.2 years in July 2002 because of increased risk of breast cancer and later in 2004 the estrogen-only trial because HT increased the risk of stroke, decreased the risk of hip fracture, and did not affect coronary heart disease incidence. WISDOM was halted in autumn 2002. These decisions had a major influence on EPHT. Conclusion Changes in Estonian society challenged EPHT to find a balance between the needs of achieving responses to the trial aims with a limited budget and simultaneously maintaining the safety of trial participants. Flexibility was the main key for success. Rapid changes are not limited only to transiting societies but are true also in developed countries and the risk must be included in planning all long-term trials. The role of ethical and data monitoring committees in situations with emerging new data from other studies needs specification. Longer funding for preventive trials and more flexibility in budgeting are mandatory. Who should prove the effectiveness of an (old drug for a new preventive indication? In preventive drug trials companies may

  18. Long-term Exercise Adherence After High-intensity Interval Training in Cardiac Rehabilitation: A Randomized Study.

    Science.gov (United States)

    Aamot, Inger-Lise; Karlsen, Trine; Dalen, Håvard; Støylen, Asbjørn

    2016-03-01

    Exercise adherence in general is reported to be problematic after cardiac rehabilitation. Additionally, vigorous exercise is associated with impaired exercise adherence. As high-intensity interval training (HIT) is frequently used as a therapy to patients with coronary artery disease in cardiac rehabilitation, the objective was to assess long-term exercise adherence following an HIT cardiac rehabilitation programme. A multicentre randomized study was carried out. Eligible participants were adults who had previously attended a 12-week HIT cardiac rehabilitation programme, as either a home-based or hospital-based HIT (treadmill exercise or group exercise). The primary outcome was change in peak oxygen uptake; secondary outcomes were self-reported and objectively measured physical activity. Out of 83 eligible participants, 76 were available for assessment (68 men/8 women, mean age 59 (8) years) at a one-year follow-up. Peak oxygen uptake was significantly elevated above baseline values, (treadmill exercise: 35.8 (6.4) vs. 37.4 (7.4) ml kg(-1)  min(-1) , group exercise: 32.7 (6.5) vs. 34.1 (5.8) ml kg(-1)  min(-1) and home-based exercise: 34.5 (4.9) vs. 36.7 (5.8) ml kg(-1)  min(-1) at baseline and follow-up, respectively), with no significant differences between groups. The majority of the participants (>90%) met the recommended daily level of 30 minutes of moderate physical activity. The home-based group showed a strong trend towards increased physical activity compared with the hospital-based groups. The results from this study have shown that both home-based and hospital-based HIT in cardiac rehabilitation induce promising long-term exercise adherence, with maintenance of peak oxygen uptake significantly above baseline values at a one-year follow-up. The implication for physiotherapy practice is that HIT in cardiac rehabilitation induces satisfactory long-term exercise adherence. Copyright © 2015 John Wiley & Sons, Ltd.

  19. Evaluation of Long-Term Cochlear Implant Use in Subjects With Acquired Unilateral Profound Hearing Loss: Focus on Binaural Auditory Outcomes.

    Science.gov (United States)

    Mertens, Griet; De Bodt, Marc; Van de Heyning, Paul

    Cochlear implantation (CI) in subjects with unilateral profound sensorineural hearing loss was investigated. The authors of the present study demonstrated the binaural auditory outcomes in a 12- and 36-month prospective cohort outcome study. The present study aimed to do a long-term (LT) evaluation of the auditory outcomes in an analogous study group. LT evaluation was derived from 12 single-sided deaf (SSD) CI recipients and from 11 CI recipients with asymmetric hearing loss (AHL). A structured interview was conducted with each subjects. Speech perception in noise and sound localization were assessed in a CIOFF and in a CION condition. Four binaural effects were calculated: summation effect (S0N0), squelch effect (S0NCI), combined head shadow effect (SCIN0), and spatial release from masking (SRM). At the LT evaluation, the contribution of a CI or a bone conduction device on speech perception in noise was investigated in two challenging spatial configurations in the SSD group. All (23/23) subjects wore their CI 7 days a week at LT follow-up evaluation, which ranged from 3 to 10 years after implantation. In the SSD group, a significant combined head shadow effect of 3.17 dB and an SRM benefit of 4.33 dB were found. In the AHL group, on the other hand, the summation effect (2.00 dB), the squelch effect (2.67 dB), the combined head shadow effect (3.67 dB), and SRM benefit (2.00 dB) were significant at LT testing. In both the spatial challenging configurations, the speech in noise results was significantly worse in the condition with the bone conduction device compared with the unaided condition. No negative effect was found for the CION condition. A significant benefit in the CION condition was found for sound localization compared with the CIOFF condition in the SSD group and in the AHL group. All subjects wore their CI 7 days a week at LT follow-up evaluation. The presence of binaural effects has been demonstrated with speech in noise testing, sound localization

  20. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. An exploratory short-term double-blind randomized trial of varenicline versus nicotine patch for smoking cessation in women.

    Science.gov (United States)

    Gray, Kevin M; McClure, Erin A; Baker, Nathaniel L; Hartwell, Karen J; Carpenter, Matthew J; Saladin, Michael E

    2015-06-01

    Within a parent study examining ovarian hormone effects on smoking cessation in women, we conducted an exploratory short-term trial of varenicline versus transdermal nicotine patch. Double-blind double-dummy randomized trial. Single-site out-patient research clinic in the United States. Female smokers, ages 18-45 years and averaging ≥10 cigarettes per day for at least 6 months (n=140). Participants were randomized to receive a 4-week course of (a) varenicline tablets and placebo patches (n = 67) or (b) placebo tablets and nicotine patches (n=73). Two brief cessation counseling sessions were provided for all participants. The outcome of primary clinical interest was 2-week end-of-treatment abstinence. Secondary outcomes included 1- and 4-week end-of treatment abstinence and abstinence at a post-treatment follow-up visit occurring 4 weeks after treatment conclusion. Breath carbon monoxide (≤ 10 parts per million) was used to confirm biochemically self-reported abstinence. Two-week end-of-treatment abstinence was achieved by 37.3% (25 of 67) of varenicline participants and by 17.8% (13 of 73) of nicotine patch participants [odds ratio (OR) = 2.7, 95% confidence interval (CI)=1.3-6.0, P=0.011]. One-week (44.8 versus 20.6%, OR=3.1, 95% CI=1.5-6.6, P=0.003) and 4-week (22.4 versus 9.6%, OR=2.7, 95% CI=1.0-7.2, P=0.043) end-of-treatment abstinence similarly favored varenicline, although post-treatment follow-up Russell Standard abstinence was not significantly different between groups (23.9 versus 13.7%, OR=2.0, 95% CI=0.8-4.7, P=0.126). In an exploratory 4-week head-to-head trial in female smokers, varenicline, compared with nicotine patch, more than doubled the odds of end-of-treatment abstinence, although this diminished somewhat at post-treatment follow-up. © 2015 Society for the Study of Addiction.

  18. Long-term far-transfer effects of working memory training in children with ADHD: a randomized controlled trial.

    Science.gov (United States)

    Bigorra, Aitana; Garolera, Maite; Guijarro, Silvina; Hervás, Amaia

    2016-08-01

    ADHD affects working memory (WM) and other executive functions (EFs) and thereby negatively impacts school performance, clinical symptoms and functional impairment. The main aim of this study was to analyse the efficacy of computerized WM training (CWMT) on EF rating scales. A secondary objective was to assess its efficacy on performance-based measures of EF (PBMEF), learning, clinical symptoms and functional impairment. 66 children with combined-type ADHD between 7 and 12 years of age from the Child and Adolescent Psychiatric Unit (Spain) were included in this randomized, double-blind, placebo-controlled, parallel-group clinical trial. The participants were randomized (1:1) to an experimental group (EG) (CWMT) (n = 36) or a control group (CG) (placebo training). Assessments were conducted at baseline (T0), 1-2 weeks (T1), and 6 months post-intervention (T2) with the administration of EF rating scales, PBMEF, measures of academic achievement, and questionnaires regarding clinical symptoms and functional impairment. Participants, parents, teachers and professionals who performed the cognitive assessments were blinded. Adjusted multiple linear regression analysis showed significant improvements in EF scales-parent version, from T1 to T2, on the metacognition index [p = 0.03, d' = -0.78 (95 % CI -1.28 to -0.27)] and on WM (also significant at T2-T0) and plan/organize subscales. Significant improvements were also noted in EF scales-teacher version, from T0 to T1 and T2, on the metacognitive index [p = 0.05, d' = -0.37 (95 % CI -0.86 to 0.12) T1-T0, p = 0.02, d' = -0.81 (95 % CI -1.31 to -0.30) T2-T0] and on the initiate, WM, monitor and shift subscales. There were also significant improvements in PBMEF, ADHD symptoms, and functional impairment. CWMT had a significant impact on ADHD deficits by achieving long-term far-transfer effects.