WorldWideScience

Sample records for preloaded time trial

  1. Assessing cardiac preload by the Initial Systolic Time Interval obtained from impedance cardiography

    Directory of Open Access Journals (Sweden)

    Jan H Meijer

    2010-01-01

    Full Text Available The Initial Systolic Time Interval (ISTI, obtained from the electrocardiogram (ECG and impedance cardiogram (ICG, is considered to be a measure for the time delay between the electrical and mechanical activity of the heart and reflects an early active period of the cardiac cycle. The clinical relevance of this time interval is subject of study. This paper presents preliminary results of a pilot study investigating the use of ISTI in evaluating and predicting the circulatory response to fluid administration in patients after coronary artery bypass graft surgery, by comparing ISTI with cardiac output (CO responsiveness. Also the use of the pulse transit time (PTT, earlier recommended for this purpose, is investigated. The results show an inverse relationship between ISTI and CO at all moments of fluid administration and also an inverse relationship between the changes ΔISTI and ΔCO before and after full fluid administration. No relationships between PTT and CO or ΔPTT and ΔCO were found. It is concluded that ISTI is dependent upon preload, and that ISTI has the potential to be used as a clinical parameter assessing preload.

  2. Effects of preload 4 repetition maximum on 100-m sprint times in collegiate women.

    Science.gov (United States)

    Linder, Elizabeth E; Prins, Jan H; Murata, Nathan M; Derenne, Coop; Morgan, Charles F; Solomon, John R

    2010-05-01

    The purpose of this study was to determine the effects of postactivation potentiation (PAP) on track-sprint performance after a preload set of 4 repetition maximum (4RM) parallel back half-squat exercises in collegiate women. All subjects (n = 12) participated in 2 testing sessions over a 3-week period. During the first testing session, subjects performed the Controlled protocol consisting of a 4-minute standardized warm-up, followed by a 4-minute active rest, a 100-m track sprint, a second 4-minute active rest, finalized with a second 100-m sprint. The second testing session, the Treatment protocol, consisted of a 4-minute standardized warm-up, followed by 4-minute active rest, sprint, a second 4-minute active rest, a warm-up of 4RM parallel back half-squat, a third 9-minute active rest, finalized with a second sprint. The results indicated that there was a significant improvement of 0.19 seconds (p sprint was preceded by a 4RM back-squat protocol during Treatment. The standardized effect size, d, was 0.82, indicating a large effect size. Additionally, the results indicated that it would be expected that mean sprint times would increase 0.04-0.34 seconds (p 0.05). The findings suggest that performing a 4RM parallel back half-squat warm-up before a track sprint will have a positive PAP affect on decreased track-sprint times. Track coaches, looking for the "competitive edge" (PAP effect) may re-warm up their sprinters during meets.

  3. Effects of grapefruit, grapefruit juice and water preloads on energy balance, weight loss, body composition, and cardiometabolic risk in free-living obese adults

    Directory of Open Access Journals (Sweden)

    Niswender Kevin D

    2011-02-01

    Full Text Available Abstract Background Reducing dietary energy density has proven to be an effective strategy to reduce energy intakes and promote weight control. This effect appears most robust when a low energy dense preload is consumed before meals. Yet, much discussion continues regarding the optimal form of a preload. The purpose of the present study was to compare effects of a solid (grapefruit, liquid (grapefruit juice and water preload consumed prior to breakfast, lunch and dinner in the context of caloric restriction. Methods Eighty-five obese adults (BMI 30-39.9 were randomly assigned to (127 g grapefruit (GF, grapefruit juice (GFJ or water preload for 12 weeks after completing a 2-week caloric restriction phase. Preloads were matched for weight, calories, water content, and energy density. Weekly measures included blood pressure, weight, anthropometry and 24-hour dietary intakes. Resting energy expenditure, body composition, physical performance and cardiometabolic risk biomarkers were assessed. Results The total amount (grams of food consumed did not change over time. Yet, after preloads were combined with caloric restriction, average dietary energy density and total energy intakes decreased by 20-29% from baseline values. Subjects experienced 7.1% weight loss overall, with significant decreases in percentage body, trunk, android and gynoid fat, as well as waist circumferences (-4.5 cm. However, differences were not statistically significant among groups. Nevertheless, the amount and direction of change in serum HDL-cholesterol levels in GF (+6.2% and GFJ (+8.2% preload groups was significantly greater than water preload group (-3.7%. Conclusions These data indicate that incorporating consumption of a low energy dense dietary preload in a caloric restricted diet is a highly effective weight loss strategy. But, the form of the preload did not have differential effects on energy balance, weight loss or body composition. It is notable that subjects in GF

  4. Preloaded Motorway Embankments

    DEFF Research Database (Denmark)

    Steenfelt, J. S.; Jørgensen, Mogens B.; Jørgensen, P. O.

    1999-01-01

    Road construction, particularly involving soft soil replacement, draws very heavily on the scarce resources of sand and gravel. One environmentally appealing alternative to complete soft soil replacement is preloading where the sand/gravel materials may be re-used along the road alignment...

  5. Preloaded Motorway Embankments

    DEFF Research Database (Denmark)

    Steenfelt, Jørgen S.; Jørgensen, Mogens B.; Jørgensen, P.O.

    Road construction, particularly involving soft soil replacement, draws very heavily on the scarce resources of sand and gravel. One environmentally appealing alternative to complete soft soil replacement is pre-loading where the sand/gravel materials may be re-used along the road alignment...

  6. Monitoring preload performance

    Energy Technology Data Exchange (ETDEWEB)

    Russell, J.B.; Lawrence, C.A.; Paddock, M.W.; Ross, D.

    1999-07-01

    Reconstruction of State Highway 29 (STH 29) in north central Wisconsin was complicated by two separate deposits of compressible peat and organic silt within the highway right-of-way. The deposits ranged from about 3 to 11 meters in thickness over about 900 meters of the reconstruction alignment. Excavation and removal of the peat and organic silt was evaluated, but was determined to be cost prohibitive. Preloading was determined to be a cost effective and environmentally friendly solution, and was implemented at both deposits to induce the expected consolidation and long-term secondary compression of the final highway embankment and pavement sections. This paper presents the design, instrumentation, and rheological modeling procedures used to complete the project.

  7. DLC screw preload. Loosening prevention

    Directory of Open Access Journals (Sweden)

    Ivete Aparecida de Mattias Sartori

    2008-01-01

    Full Text Available The screw loosening is a reason to prosthetic rehabilitation failure. However, the DLC (Diamond-like carbon screw treatment lead thefriction decrease and sliding between the components, which increases the screw preload benefit and decreases the chance of looseningoccurrence. This case shows a clinical indication of the association of the correct preload applied and the DLC screw, which can be considered an optimized protocol to solve screw loosening recidivate of unitary prosthesis in anterior maxillary site.

  8. A Comparison of Mixed-Method Cooling Interventions on Preloaded Running Performance in the Heat.

    Science.gov (United States)

    Stevens, Christopher J; Bennett, Kyle J M; Sculley, Dean V; Callister, Robin; Taylor, Lee; Dascombe, Ben J

    2017-03-01

    Stevens, CJ, Bennett, KJM, Sculley, DV, Callister, R, Taylor, L, and Dascombe, BJ. A comparison of mixed-method cooling interventions on preloaded running performance in the heat. J Strength Cond Res 31(3): 620-629, 2017-The purpose of this investigation was to assess the effect of combining practical methods to cool the body on endurance running performance and physiology in the heat. Eleven trained male runners completed 4 randomized, preloaded running time trials (20 minutes at 70% V[Combining Dot Above]O2max and a 3 km time trial) on a nonmotorized treadmill in the heat (33° C). Trials consisted of precooling by combined cold-water immersion and ice slurry ingestion (PRE), midcooling by combined facial water spray and menthol mouth rinse (MID), a combination of all methods (ALL), and control (CON). Performance time was significantly faster in MID (13.7 ± 1.2 minutes; p < 0.01) and ALL (13.7 ± 1.4 minutes; p = 0.04) but not PRE (13.9 ± 1.4 minutes; p = 0.24) when compared with CON (14.2 ± 1.2 minutes). Precooling significantly reduced rectal temperature (initially by 0.5 ± 0.2° C), mean skin temperature, heart rate and sweat rate, and increased iEMG activity, whereas midcooling significantly increased expired air volume and respiratory exchange ratio compared with control. Significant decreases in forehead temperature, thermal sensation, and postexercise blood prolactin concentration were observed in all conditions compared with control. Performance was improved with midcooling, whereas precooling had little or no influence. Midcooling may have improved performance through an attenuated inhibitory psychophysiological and endocrine response to the heat.

  9. Preloading of bolted connections in nuclear reactor component supports

    Energy Technology Data Exchange (ETDEWEB)

    Yahr, G T

    1984-10-01

    A number of failures of threaded fasteners in nuclear reactor component supports have been reported. Many of those failures were attributed to stress corrosion cracking. This report discusses how stress corrosion cracking can be avoided in bolting by controlling the maximum bolt preloads so that the sustained stresses in the bolts are below the level required to cause stress corrosion cracking. This is a basic departure from ordinary bolted joint design where the only limits on preload are on the minimum preload. Emphasis is placed on the importance of detailed analysis to determine the acceptable range of preload and the selection of a method for measuring the preload that is sufficiently accurate to ensure that the preload is actually within the acceptable range. Procedures for determining acceptable preload range are given, and the accuracy of various methods of measuring preload is discussed.

  10. Effect of a preload force on anchor system frequency

    Institute of Scientific and Technical Information of China (English)

    Lu Aihong; Xu Jinhai; Liu Haishun

    2013-01-01

    The interrelationship between preload forces and natural frequencies of anchors was obtained from the structure of an anchor and its mechanical characteristics.We established a numerical model for the dynamic analysis of a bolt support system taking into consideration the working surroundings of the anchor.The natural frequency distribution of the system under various preload forces of the anchor was analyzed with ANSYS.Our results show that each order of the system frequency varied with an increase in preload forces.A single order frequency decreased with an increase in the preload force.A preload force affected low-order frequencies more than high-order frequencies.We obtained a functional relationship by fitting preload forces and fundamental frequencies,which was in agreement with our theoretical considerations.This study provides theoretical support for the detection of preload forces.

  11. The impact of a preloaded intraocular lens delivery system on operating room efficiency in routine cataract surgery

    Science.gov (United States)

    Jones, Jason J; Chu, Jeffrey; Graham, Jacob; Zaluski, Serge; Rocha, Guillermo

    2016-01-01

    Purpose The aim of this study was to evaluate the operational impact of using preloaded intraocular lens (IOL) delivery systems compared with manually loaded IOL delivery processes during routine cataract surgeries. Methods Time and motion data, staff and surgery schedules, and cost accounting reports were collected across three sites located in the US, France, and Canada. Time and motion data were collected for manually loaded IOL processes and preloaded IOL delivery systems over four surgery days. Staff and surgery schedules and cost accounting reports were collected during the 2 months prior and after introduction of the preloaded IOL delivery system. Results The study included a total of 154 routine cataract surgeries across all three sites. Of these, 77 surgeries were performed using a preloaded IOL delivery system, and the remaining 77 surgeries were performed using a manual IOL delivery process. Across all three sites, use of the preloaded IOL delivery system significantly decreased mean total case time by 6.2%–12.0% (P<0.001 for data from Canada and the US and P<0.05 for data from France). Use of the preloaded delivery system also decreased surgeon lens time, surgeon delays, and eliminated lens touches during IOL preparation. Conclusion Compared to a manual IOL delivery process, use of a preloaded IOL delivery system for cataract surgery reduced total case time, total surgeon lens time, surgeon delays, and eliminated IOL touches. The time savings provided by the preloaded IOL delivery system provide an opportunity for sites to improve routine cataract surgery throughput without impacting surgeon or staff capacity. PMID:27382245

  12. Does fasting influence preload responsiveness in ASA 1 and 2 volunteers?

    Science.gov (United States)

    Alves, Daniel Rodrigues; Ribeiras, Regina

    Preoperative fasting was long regarded as an important cause of fluid depletion, leading to hemodynamic instability during surgery should replenishment is not promptly instituted. Lately, this traditional point of view has been progressively challenged, and a growing number of authors now propose a more restrictive approach to fluid management, although doubt remains as to the true hemodynamic influence of preoperative fasting. We designed an observational, analytic, prospective, longitudinal study in which 31 ASA 1 and ASA 2 volunteers underwent an echocardiographic examination both before and after a fasting period of at least 6hours (h). Data from both static and dynamic preload indices were obtained on both periods, and subsequently compared. Static preload indices exhibited a markedly variable behaviour with fasting. Dynamic indices, however, were far more consistent with one another, all pointing in the same direction, i.e., evidencing no statistically significant change with the fasting period. We also analysed the reliability of dynamic indices to respond to known, intentional preload changes. Aortic velocity time integral (VTI) variation with the passive leg raise manoeuvre was the only variable that proved to be sensitive enough to consistently signal the presence of preload variation. Fasting does not appear to cause a change in preload of conscious volunteers nor does it significantly alter their position in the Frank-Starling curve, even with longer fasting times than usually recommended. Transaortic VTI variation with the passive leg raise manoeuvre is the most robust dynamic index (of those studied) to evaluate preload responsiveness in spontaneously breathing patients. Copyright © 2016 Sociedade Brasileira de Anestesiologia. Published by Elsevier Editora Ltda. All rights reserved.

  13. Experimental study on bearing preload optimum of machine tool spindle

    Science.gov (United States)

    Xu, Tao; Xu, Guanghua; Zhang, Qin; Hua, Cheng; Zhang, Hu; Jiang, Kuosheng

    2012-05-01

    An experimental study is conducted to investigate the possibility and the effect of temperature rise and vibration level of bearing by adjusting axial preloads and radial loads in spindle bearing test rig. The shaft of the test rig is driven by a motorized high speed spindle at the range of 0~20000 rpm. The axial preloads and radial loads on bearings are controlled by using hydraulic pressure which can be adjusted automatically. Temperature rise and radial vibration of test bearings are measured by thermocouples and Polytec portable laser vibrometer PDV100. Experiment shows that the temperature rise of bearings is nonlinear varying with the increase of radial loads, but temperature rise almost increases linearly with the increase of axial preload and rotating speed. In this paper, an alternate axial preload is used for bearings. When the rotating speed passes through the critical speed of the shaft, axial preload of bearings will have a remarkable effect. The low preload could reduce bearing vibration and temperature rise for bearings as well. At the others speed, the high preload could improve the vibration performance of high speed spindle and the bearing temperature was lower than that of the constant pressure preload spindle.

  14. Semantic-preload video model based on VOP coding

    Science.gov (United States)

    Yang, Jianping; Zhang, Jie; Chen, Xiangjun

    2013-03-01

    In recent years, in order to reduce semantic gap which exists between high-level semantics and low-level features of video when the human understanding image or video, people mostly try the method of video annotation where in signal's downstream, namely further (again) attach labels to the content in video-database. Few people focus on the idea that: Use limited interaction and the means of comprehensive segmentation (including optical technologies) from the front-end of collection of video information (i.e. video camera), with video semantics analysis technology and corresponding concepts sets (i.e. ontology) which belong in a certain domain, as well as story shooting script and the task description of scene shooting etc; Apply different-level semantic descriptions to enrich the attributes of video object and the attributes of image region, then forms a new video model which is based on Video Object Plan (VOP) Coding. This model has potential intellectualized features, and carries a large amount of metadata, and embedded intermediate-level semantic concept into every object. This paper focuses on the latter, and presents a framework of a new video model. At present, this new video model is temporarily named "Video Model of Semantic-Preloaded or Semantic-Preload Video Model (simplified into VMoSP or SPVM)". This model mainly researches how to add labeling to video objects and image regions in real time, here video object and image region are usually used intermediate semantic labeling, and this work is placed on signal's upstream (i.e. video capture production stage). Because of the research needs, this paper also tries to analyses the hierarchic structure of video, and divides the hierarchic structure into nine hierarchy semantic levels, of course, this nine hierarchy only involved in video production process. In addition, the paper also point out that here semantic level tagging work (i.e. semantic preloading) only refers to the four middle-level semantic. All in

  15. Improvements in Cycling but Not Handcycling 10 km Time Trial Performance in Habitual Caffeine Users

    Science.gov (United States)

    Graham-Paulson, Terri; Perret, Claudio; Goosey-Tolfrey, Victoria

    2016-01-01

    Caffeine supplementation during whole-/lower-body exercise is well-researched, yet evidence of its effect during upper-body exercise is equivocal. The current study explored the effects of caffeine on cycling/handcycling 10 km time trial (TT) performance in habitual caffeine users. Eleven recreationally trained males (mean (SD) age 24 (4) years, body mass 85.1 (14.6) kg, cycling/handcycling peak oxygen uptake (V·peak) 42.9 (7.3)/27.6 (5.1) mL∙kg∙min−1, 160 (168) mg/day caffeine consumption) completed two maximal incremental tests and two familiarization sessions. During four subsequent visits, participants cycled/handcycled for 30 min at 65% mode-specific V·peak (preload) followed by a 10 km TT following the ingestion of 4 mg∙kg−1 caffeine (CAF) or placebo (PLA). Caffeine significantly improved cycling (2.0 (2.0)%; 16:35 vs. 16:56 min; p = 0.033) but not handcycling (1.8 (3.0)%; 24:10 vs. 24:36 min; p = 0.153) TT performance compared to PLA. The improvement during cycling can be attributed to the increased power output during the first and last 2 km during CAF. Higher blood lactate concentration (Bla) was reported during CAF compared to PLA (p < 0.007) and was evident 5 min post-TT during cycling (11.2 ± 2.6 and 8.8 ± 3.2 mmol/L; p = 0.001) and handcycling (10.6 ± 2.5 and 9.2 ± 2.9 mmol/L; p = 0.006). Lower overall ratings of perceived exertion (RPE) were seen following CAF during the preload (p < 0.05) but not post-TT. Lower peripheral RPE were reported at 20 min during cycling and at 30 min during handcycling, and lower central RPE was seen at 30 min during cycling (p < 0.05). Caffeine improved cycling but not handcycling TT performance. The lack of improvement during handcycling may be due to the smaller active muscle mass, elevated (Bla) and/or participants’ training status. PMID:27348000

  16. Improvements in Cycling but Not Handcycling 10 km Time Trial Performance in Habitual Caffeine Users

    Directory of Open Access Journals (Sweden)

    Terri Graham-Paulson

    2016-06-01

    Full Text Available Caffeine supplementation during whole-/lower-body exercise is well-researched, yet evidence of its effect during upper-body exercise is equivocal. The current study explored the effects of caffeine on cycling/handcycling 10 km time trial (TT performance in habitual caffeine users. Eleven recreationally trained males (mean (SD age 24 (4 years, body mass 85.1 (14.6 kg, cycling/handcycling peak oxygen uptake ( V · peak 42.9 (7.3/27.6 (5.1 mL∙kg∙min−1, 160 (168 mg/day caffeine consumption completed two maximal incremental tests and two familiarization sessions. During four subsequent visits, participants cycled/handcycled for 30 min at 65% mode-specific V · peak (preload followed by a 10 km TT following the ingestion of 4 mg∙kg−1 caffeine (CAF or placebo (PLA. Caffeine significantly improved cycling (2.0 (2.0%; 16:35 vs. 16:56 min; p = 0.033 but not handcycling (1.8 (3.0%; 24:10 vs. 24:36 min; p = 0.153 TT performance compared to PLA. The improvement during cycling can be attributed to the increased power output during the first and last 2 km during CAF. Higher blood lactate concentration (Bla was reported during CAF compared to PLA (p < 0.007 and was evident 5 min post-TT during cycling (11.2 ± 2.6 and 8.8 ± 3.2 mmol/L; p = 0.001 and handcycling (10.6 ± 2.5 and 9.2 ± 2.9 mmol/L; p = 0.006. Lower overall ratings of perceived exertion (RPE were seen following CAF during the preload (p < 0.05 but not post-TT. Lower peripheral RPE were reported at 20 min during cycling and at 30 min during handcycling, and lower central RPE was seen at 30 min during cycling (p < 0.05. Caffeine improved cycling but not handcycling TT performance. The lack of improvement during handcycling may be due to the smaller active muscle mass, elevated (Bla and/or participants’ training status.

  17. A New Method of Combination of Electroosmosis, Vacuum and Surcharge Preloading for Soft Ground Improvement

    Institute of Scientific and Technical Information of China (English)

    刘汉龙; 崔允亮; 沈扬; 丁选明

    2014-01-01

    As-a-rapid-and-effective-ground-improvement-method-is-urgently-required-for-the-booming-land-reclamation-in-China’s-coastal-area,-this-study-proposes-a-new-combined-method-of-electroosmosis,-vacuum-preloading-and-surcharge-preloading.-A-new-type-of-electrical-prefabricated-vertical-drain-(ePVD)-and-a-new-electroosmotic-drainage-system-are-suggested-to-allow-the-application-of-the-new-method.-This-combined-method-is-then-field-tested-and-compared-with-the-conventional-vacuum-combined-with-surcharge-preloading-method.-The-monitoring-and-foundation-test-results-show-that-the-new-method-induces-a-settlement-20%larger-than-that-of-the-conventional-vacuum-combined-with-surcharge-preloading-method-in-the-same-treatment-period,-and-saves-approximately-half-of-the-treatment-time-compared-with-the-vacuum-combined-with-surcharge-preloading-method-according-to-the-finite-element-prediction-of-the-settlement.-The-proposed-method-also-increases-the-vane-shear-strength-of-the-soil-significantly.-The-bearing-capacity-of-the-ground-improved-by-use-of-the-new-proposed-method-raises-118%.-In-comparison,-there-is-only-a-75%rise-when-using-the-vacuum-combined-with-surcharge-preloading-method-during-the-same-reinforcement-period.-All-results-indicate-that-the-proposed-combined-method-is-effective-and-suitable-for-reinforcing-the-soft-clay-ground.-Besides,-the-voltage-applied-between-the-anode-and-cathode-increases-exponentially-versus-treatment-time-when-the-output-current-of-power-supplies-is-kept-constant.-Most-of-the-voltage-potential-in-electroosmosis-is-lost-at-electrodes,-leaving-smaller-than-50%-of-the-voltage-to-be-effectively-transmitted-into-the-soil.

  18. Physiological determinants of the cycling time trial.

    Science.gov (United States)

    Støren, Øyvind; Ulevåg, Kåre; Larsen, Morten H; Støa, Eva M; Helgerud, Jan

    2013-09-01

    The purpose of this study was to examine the physiological determinants of endurance cycling time trial (TT) performance in a heterogeneous group of competitive male road cyclists. About 15 male cyclists who had all competed in cycling the preceding season were tested for the anthropometric variables height, body weight, leg length, ankle circumference, and body fat percentage. They were also tested for maximal oxygen consumption (VO2max), lactate threshold (LT), metabolic cost of cycling (CC), peak power output and average power output during a 30-second Wingate test, 1 repetition maximum and peak power in half squats, and a TT test on an ergometer. Heart rate and cadence (rounds per minute, RPM) were continuously measured during all cycle tests. Pearson Bivariate correlation tests and single linear regression tests were performed to obtain correlation coefficients (r), effect size (F), standard error of estimate (SEE), and 95% confidence interval. The single variable that correlated best with TT performance was power output at LT (r = 0.86, p equation representing both aerobic and anaerobic endurance capacity TT(w) = 0.95 ([VO2max/CC] TT%VO2max) + 0.05 (Wingate average) correlated strongly with TT laboratory performance (r = 0.93, p < 0.01, SEE = 5.7%). None of the strength, power, or anthropometric variables correlated significantly with TT laboratory performance.

  19. Whey protein preloads are more beneficial than soy protein preloads in regulating appetite, calorie intake, anthropometry, and body composition of overweight and obese men.

    Science.gov (United States)

    Tahavorgar, Atefeh; Vafa, Mohammadreza; Shidfar, Farzad; Gohari, Mahmoodreza; Heydari, Iraj

    2014-10-01

    High-protein diets exert beneficial effects on appetite, anthropometry, and body composition; however, the effects of protein preloads depend on the amount, type, and time of consumption. Therefore, we hypothesized that long-term supplemental preloads of whey protein concentrate (WPC) and soy protein isolate (SPI) consumed 30 minutes before the largest meal would decrease appetite, calorie intake (CI), and anthropometry and improve body composition in overweight and obese men in free-living conditions. The subjects included 45 men with a body mass index between 25 and 40 kg/m(2) and who were randomly allocated to either the WPC (n = 26) or SPI (n = 19) groups. For 12 weeks, the subjects consumed 65 g WPC or 60 g SPI that was dissolved in 500 mL water 30 minutes before their ad libitum lunch. Appetite, CI, anthropometry, and body composition were assessed before and after the study and biweekly throughout. After 12 weeks, mean changes between the groups were significant for appetite (P = .032), CI (P = .045), anthropometry (body weight [P = .008], body mass index [P = .006], and waist circumference), and body composition (body fat mass and lean muscle [P < .001]). Relative to baseline, within-group mean changes from WPC were significant for appetite, CI, anthropometry, and body composition (P < .001). In the SPI group, mean changes were significant, relative to baseline, for all variables except lean muscle (P = .37). According to this 12-week study, WPC preloads conducted 30 minutes prior to the ad libitum main meal exerted stronger beneficial effects than did SPI preloads on appetite, CI, anthropometry, and body composition of free-living overweight and obese men.

  20. Stress Corrosion Cracking of X80 Pipeline Steel in Near-Neutral pH Environment under Constant Load Tests with and without Preload

    Institute of Scientific and Technical Information of China (English)

    Y.Z. Jia; J.Q. Wang; E.H. Han; W. Ke1

    2011-01-01

    Constant load tests in NS4 solution purged with N2-5%CO2 gas mixture were conducted on American Petroleum Institute (API) X80 pipeline steel applied in the 2nd West-East (;as Pipeline project with and without preload. The results show that cracks could initiate and propagate in X80 pipeline steel in near-neutral pH environment under a constant load condition. The life of crack initiation and propagation increased with decreasing applied stress. Preload did not change its corrosion behavior obviously. However, preload reduced the time for crack initiation.

  1. Improvements in Cycling but Not Handcycling 10 km Time Trial Performance in Habitual Caffeine Users.

    Science.gov (United States)

    Graham-Paulson, Terri; Perret, Claudio; Goosey-Tolfrey, Victoria

    2016-06-25

    Caffeine supplementation during whole-/lower-body exercise is well-researched, yet evidence of its effect during upper-body exercise is equivocal. The current study explored the effects of caffeine on cycling/handcycling 10 km time trial (TT) performance in habitual caffeine users. Eleven recreationally trained males (mean (SD) age 24 (4) years, body mass 85.1 (14.6) kg, cycling/handcycling peak oxygen uptake ( V · peak) 42.9 (7.3)/27.6 (5.1) mL∙kg∙min(-1), 160 (168) mg/day caffeine consumption) completed two maximal incremental tests and two familiarization sessions. During four subsequent visits, participants cycled/handcycled for 30 min at 65% mode-specific V · peak (preload) followed by a 10 km TT following the ingestion of 4 mg∙kg(-1) caffeine (CAF) or placebo (PLA). Caffeine significantly improved cycling (2.0 (2.0)%; 16:35 vs. 16:56 min; p = 0.033) but not handcycling (1.8 (3.0)%; 24:10 vs. 24:36 min; p = 0.153) TT performance compared to PLA. The improvement during cycling can be attributed to the increased power output during the first and last 2 km during CAF. Higher blood lactate concentration (Bla) was reported during CAF compared to PLA (p Caffeine improved cycling but not handcycling TT performance. The lack of improvement during handcycling may be due to the smaller active muscle mass, elevated (Bla) and/or participants' training status.

  2. Comparison of colloid preload versus coload under low dose spinal anesthesia for cesarean delivery

    Science.gov (United States)

    Varshney, Rohit; Jain, Gaurav

    2013-01-01

    Background: Although fluid bolus is considered as a conventional prophylactic measure to prevent spinal-induced hypotension; vasopressors are nevertheless required. Low dose spinal anesthetics could markedly reduce such episodes of hypotension, by minimizing sympathetic blockade. Aims: We chose to compare the relative efficacy of colloid preload versus coload under low dose spinal anesthesia, for elective cesarean delivery. Settings and Design: A prospective, randomized, double-blinded study. Materials and Methods: In total, 42 parturients were randomized to receive a preload (Group P) of hydroxyl ethyl starch (10 ml/kg) over 20 min before initiation of low dose spinal anesthesia (hyperbaric bupivacaine 5.5 mg with fentanyl 25 μg) or coload (Group C) of an identical fluid over 5 min, starting at the time of identification of cerebrospinal fluid. Our primary outcome included hemodynamic parameters and the incidence of hypotension. The neonatal outcome and side-effects were also monitored. Statistical Analysis: Mann-Whitney U test and Fisher's exact/Chi-square test, whichever appropriate. A P < 0.05 was considered to be significant. Results: The incidence of hypotension was lower in Group P (10%) when compared with Group C (25%), though insignificant statistically. The hemodynamic parameters were better in Group P, though intergroup statistical differences were not observed. The time to the first episode of hypotension was longer in the Group P (17 min) as compared with Group C (14 min). No notable side-effects or adverse neonatal outcome was noted. Conclusion: Colloid preload has a clinical advantage over the coload strategy, in reducing hypotensive episodes under low dose spinal anesthesia. Preload is better under large hemodynamic fluctuations while coload is preferable for emergency scenarios. PMID:25885987

  3. Cardiac preload responsiveness in children with cardiovascular dysfunction or dilated cardiomyopathy: a multicenter observational study.

    Science.gov (United States)

    de la Oliva, Pedro; Menéndez-Suso, Juan J; Iglesias-Bouzas, Mabel; Álvarez-Rojas, Elena; González-Gómez, José M; Roselló, Patricia; Sánchez-Díaz, Juan I; Jaraba, Susana

    2015-01-01

    To characterize cardiac preload responsiveness in pediatric patients with cardiovascular dysfunction and dilated cardiomyopathy using global end-diastolic volume index, stroke volume index, cardiac index, and extravascular lung water index. Prospective multicenter observational study. Medical/surgical PICUs of seven Spanish University Medical Centers. Seventy-five pediatric patients (42 male, 33 female), median age 36 months (range, 1-207 mo), were divided into three groups: normal cardiovascular status, cardiovascular dysfunction, and dilated cardiomyopathy. All patients received hemodynamic monitoring with PiCCO2 (Pulsion Medical System SE, Munich, Germany). We evaluated 598 transpulmonary thermodilution sets of measurements. In 40 patients, stroke volume index, cardiac index, and global end-diastolic volume index were measured before and after 66 fluid challenges and loadings to test fluid responsiveness at different preload levels. Global end-diastolic volume versus predicted body surface area exhibits a power-law relationship: Global end-diastolic volume = 488.8·predicted body surface area (r = 0.93). Four levels of cardiac preload were established from the resulting "normal" global end-diastolic volume index (= 488.8·predicted body surface area). Stroke volume index and cardiac index versus global end-diastolic volume index/normal global end-diastolic volume index built using a linear mixed model analysis emulated Frank-Starling curves: in cardiovascular dysfunction group, stroke volume index (geometric mean [95% CI]) was 27 mL/m (24-31 mL/m) at "≤ 0.67 times normal global end-diastolic volume index," 37 mL/m (35-40 mL/m) at "> 0.67 ≤ 1.33 times normal global end-diastolic volume index" (Δ stroke volume index = 35%; p 1.33 ≤ 1.51 times normal global end-diastolic volume index" (Δ stroke volume index = 21%; p 1.51 times normal global end-diastolic volume index" (Δ stroke volume index = 4%; p = 1; area under the receiver

  4. Numerical Simulations on Buckling Failure of Preloaded Cylindrical Shell Irradiated by High Power Laser Beam

    Institute of Scientific and Technical Information of China (English)

    王吉; 王肖钧; 王峰; 赵凯

    2004-01-01

    With finite-element software ANSYS 7.0 and simple thermal-mechanical coupling constitutive relations,the buckling failure of preloaded cylindrical shell irradiated by high power laser beam was studied by numerical simulations. The buckling mode and buckling critical loading were analysed for different preloading conditions. The influence of laser intensity, beam irradiation time, preloading conditions and geometric parameters of cylindrical shell on the buckling mode were discussed. The numerical results show that: ① the buckling deformation of the cylindrical shell was concentrated in the area of laser spot and the radial buckling was the main buckling mode, ② a linear relationship between the buckling eigenvalue and the maximum temperature at the center of laser spot was approached, ③ the buckling failure of cylindrical shell was attributed to the coupling effect of the material softening and the radial deformation in the laser spot, and hence to raise the stiffness of the material would enhance the ability for anti-irradiation of structure substantially.

  5. How Have Cancer Clinical Trial Eligibility Criteria Evolved Over Time?

    Science.gov (United States)

    Yaman, Anil; Chakrabarti, Shreya; Sen, Anando; Weng, Chunhua

    2016-01-01

    Knowledge reuse of cancer trial designs may benefit from a temporal understanding of the evolution of the target populations of cancer studies over time. Therefore, we conducted a retrospective analysis of the trends of cancer trial eligibility criteria between 1999 and 2014. The yearly distributions of eligibility concepts for chemicals and drugs, procedures, observations, and medical conditions extracted from free-text eligibility criteria of 32,000 clinical trials for 89 cancer types were analyzed. We identified the concepts that trend upwards or downwards in all or selected cancer types, and the concepts that show anomalous trends for some cancers. Later, concept trends were studied in a disease-specific manner and illustrated for breast cancer. Criteria trends observed in this study are also validated and interpreted using evidence from the existing medical literature. This study contributes a method for concept trend analysis and original knowledge of the trends in cancer clinical trial eligibility criteria.

  6. Investigation of multiple spindle characteristics under non-uniform bearing preload

    Directory of Open Access Journals (Sweden)

    Yanfei Zhang

    2016-02-01

    Full Text Available The non-uniform distribution load during machining and assembly process is crucial for spindle system, especially in complex working conditions. The conception of non-uniform preload adjustment approach was proposed and experimentally investigated in this article. Based on the mechanical equivalent principle, the non-uniform preload was theoretically transformed to the combination of uniform preload and an extra moment. Then, the non-uniform preload of rolling bearing was experimentally measured and analyzed via a spacer with 15-µm wear loss on the end face. The spindle performance factors, such as rotation accuracy, temperature rising, acceleration, and vibration, were all monitored. The rotation center of spindle was deviated in different non-uniform preload conditions. Meanwhile, the temperature and vibration performance of non-uniform preload are superior to those of uniform bearing preload.

  7. Effect of compressive follower preload on the flexion-extension response of the human lumbar spine.

    Science.gov (United States)

    Patwardhan, Avinash G; Havey, Robert M; Carandang, Gerard; Simonds, James; Voronov, Leonard I; Ghanayem, Alexander J; Meade, Kevin P; Gavin, Thomas M; Paxinos, Odysseas

    2003-05-01

    Traditional experimental methods are unable to study the kinematics of whole lumbar spine specimens under physiologic compressive preloads because the spine without active musculature buckles under just 120 N of vertical load. However, the lumbar spine can support a compressive load of physiologic magnitude (up to 1200 N) without collapsing if the load is applied along a follower load path. This study tested the hypothesis that the load-displacement response of the lumbar spine in flexion-extension is affected by the magnitude of the follower preload and the follower preload path. Twenty-one fresh human cadaveric lumbar spines were tested in flexion-extension under increasing compressive follower preload applied along two distinctly different optimized preload paths. The first (neutral) preload path was considered optimum if the specimen underwent the least angular change in its lordosis when the full range of preload (0-1200 N) was applied in its neutral posture. The second (flexed) preload path was optimized for an intermediate specimen posture between neutral and full flexion. A twofold increase in flexion stiffness occurred around the neutral posture as the preload was increased from 0 to 1200 N. The preload magnitude (400 N and larger) significantly affected the range of motion (ROM), with a 25% decrease at 1200 N preload applied along the neutral path. When the preload was applied along a path optimized for an intermediate forward-flexed posture, only a 15% decrease in ROM occurred at 1200 N. The results demonstrate that whole lumbar spine specimens can be subjected to compressive follower preloads of in vivo magnitudes while allowing physiologic mobility under flexion-extension moments. The optimized follower preload provides a method to simulate the resultant vector of the muscles that allow the spine to support physiologic compressive loads induced during flexion-extension activities.

  8. Acute effect of alginate-based preload on satiety feelings, energy intake, and gastric emptying rate in healthy subjects.

    Science.gov (United States)

    Georg Jensen, Morten; Kristensen, Mette; Belza, Anita; Knudsen, Jes C; Astrup, Arne

    2012-09-01

    Viscous dietary fibers such as sodium alginate extracted from brown seaweed have received much attention lately for their potential role in energy regulation through the inhibition of energy intake and increase of satiety feelings. The aim of our study was to investigate the effect on postprandial satiety feelings, energy intake, and gastric emptying rate (GER), by the paracetamol method, of two different volumes of an alginate-based preload in normal-weight subjects. In a four-way placebo-controlled, double-blind, crossover trial, 20 subjects (age: 25.9 ± 3.4 years; BMI: 23.5 ± 1.7 kg/m(2)) were randomly assigned to receive a 3% preload concentration of either low volume (LV; 9.9 g alginate in 330 ml) or high volume (HV; 15.0 g alginate in 500 ml) alginate-based beverage, or an iso-volume placebo beverage. The preloads were ingested 30 min before a fixed breakfast and again before an ad libitum lunch. Consumption of LV-alginate preload induced a significantly lower (8.0%) energy intake than the placebo beverage (P = 0.040) at the following lunch meal, without differences in satiety feelings or paracetamol concentrations. The HV alginate significantly increased satiety feelings (P = 0.038), reduced hunger (P = 0.042) and the feeling of prospective food consumption (P = 0.027), and reduced area under the curve (iAUC) paracetamol concentrations compared to the placebo (P = 0.05). However, only a 5.5% reduction in energy intake was observed for HV alginate (P = 0.20). Although they are somewhat contradictory, our results suggest that alginate consumption does affect satiety feelings and energy intake. However, further investigation on the volume of alginate administered is needed before inferring that this fiber has a possible role in short-term energy regulation.

  9. Novel precooling strategy enhances time trial cycling in the heat.

    Science.gov (United States)

    Ross, Megan L R; Garvican, Laura A; Jeacocke, Nikki A; Laursen, Paul B; Abbiss, Chris R; Martin, David T; Burke, Louise M

    2011-01-01

    To develop and investigate the efficacy of a new precooling strategy combining external and internal techniques on the performance of a cycling time trial (TT) in a hot and humid environment. Eleven well-trained male cyclists undertook three trials of a laboratory-based cycling TT simulating the course characteristics of the Beijing Olympic Games event in a controlled hot and humid environment (32°C-35°C at 50%-60% relative humidity). The trials, separated by 3-7 d, were undertaken in a randomized crossover design and consisted of the following: 1) CON-no treatment apart from the ad libitum consumption of cold water (4°C), 2) STD COOL-whole-body immersion in cold (10°C) water for 10 min followed by wearing a cooling jacket, or 3) NEW COOL-combination of consumption of 14 g of ice slurry ("slushie") per kilogram body mass made from a commercial sports drink while applying iced towels. There was an observable effect on rectal temperature (T(rec)) before the commencement of the TT after both precooling techniques (STD COOL benefit. The effect of the STD COOL trial compared with the CON trial was "unclear." This new precooling strategy represents a practical and effective technique that could be used by athletes in preparation for endurance events undertaken in hot and humid conditions.

  10. Optimal Time-Trial Bicycle Racing with Headwinds and Tailwinds

    CERN Document Server

    Anton, A Brad

    2013-01-01

    Many time-trial and triathlon bicycle races take place on relatively flat, closed-circuit courses. In the absence of hills, riding-speed is limited almost solely by aerodynamic drag; consequently, winds can have a big effect on elapsed times. I analyze the special case of a straight out-and-back race in a steady wind, assuming the rider has a given total amount of energy to expend and can choose only two speeds - the aided speed with tailwind and the hindered speed into headwind. In this ideal circumstance the problem of choosing optimal riding speeds reduces to a constrained nonlinear optimization that can be solved with elementary calculus. My analysis reveals a practical rule of thumb that can be used more generally to choose optimal riding speeds for time-trial racing on closed-circuit courses in the presence of headwinds and tailwinds.

  11. Modelling and Estimation of Hammerstein System with Preload Nonlinearity

    Directory of Open Access Journals (Sweden)

    Khaled ELLEUCH

    2010-12-01

    Full Text Available This paper deals with modelling and parameter identification of nonlinear systems described by Hammerstein model having asymmetric static nonlinearities known as preload nonlinearity characteristic. The simultaneous use of both an easy decomposition technique and the generalized orthonormal bases leads to a particular form of Hammerstein model containing a minimal parameters number. The employ of orthonormal bases for the description of the linear dynamic block conducts to a linear regressor model, so that least squares techniques can be used for the parameter estimation. Singular Values Decomposition (SVD technique has been applied to separate the coupled parameters. To demonstrate the feasibility of the identification method, an illustrative example is included.

  12. Early clinical experience with a new preloaded one-piece intraocular lens in paediatric cataract surgery.

    Science.gov (United States)

    Gosling, D B; Chan, T K J

    2016-09-01

    PurposeTo report the clinical experience of using the Tecnis PCB00 (Abbott Medical Optics, Santa Ana, CA, USA) preloaded one-piece intraocular lens (IOL) in the setting of a tertiary referral centre for paediatric cataract.MethodsA retrospective case note review of all paediatric cataract surgeries using the Tecnis PCB00 IOL, at a single UK paediatric ophthalmology department.ResultsNine eyes in seven patients received the IOL between December 2014 and January 2016. All patients underwent lens aspiration and insertion of the IOL 'in the bag.' The indications for surgery included developmental cataract (8/9) and traumatic cataract (1/9). Mean age at the time of surgery was 7 years (range 2-14). The median improvement in logMAR best-corrected visual acuity was 0.475 (range 0.250-1.500). The mean follow-up duration was 5 months (range 1-13). No operative or post-operative complications occurred as a result of using the device.ConclusionThe Tecnis PCB00 preloaded IOL appears to be a safe and effective device in treating paediatric cataract.

  13. Dynamic Measurement of Hemodynamic Parameters and Cardiac Preload in Adults with Dengue: A Prospective Observational Study.

    Directory of Open Access Journals (Sweden)

    Vipa Thanachartwet

    Full Text Available Few previous studies have monitored hemodynamic parameters to determine the physiological process of dengue or examined inferior vena cava (IVC parameters to assess cardiac preload during the clinical phase of dengue. From January 2013 to July 2015, we prospectively studied 162 hospitalized adults with confirmed dengue viral infection using non-invasive cardiac output monitoring and bedside ultrasonography to determine changes in hemodynamic and IVC parameters and identify the types of circulatory shock that occur in patients with dengue. Of 162 patients with dengue, 17 (10.5% experienced dengue shock and 145 (89.5% did not. In patients with shock, the mean arterial pressure was significantly lower on day 6 after fever onset (P = 0.045 and the pulse pressure was significantly lower between days 4 and 7 (P50% between days 4 and 5 (P<0.05. Hypovolemic shock was observed in 9 (52.9% patients and cardiogenic shock in 8 (47.1%, with a median (interquartile range time to shock onset of 6.0 (5.0-6.5 days after fever onset, which was the median day of defervescence. Intravascular hypovolemia occurred before defervescence, whereas myocardial dysfunction occurred on the day of defervescence until 2 weeks after fever onset. Hypovolemic shock and cardiogenic shock each occurred in approximately half of the patients with dengue shock. Therefore, dynamic measures to estimate changes in hemodynamic parameters and preload should be monitored to ensure adequate fluid therapy among patients with dengue, particularly patients with dengue shock.

  14. Sodium Phosphate Supplementation and Time Trial Performance in Female Cyclists

    Directory of Open Access Journals (Sweden)

    Christopher L. Buck

    2014-09-01

    Full Text Available This study investigated the effects of three doses of sodium phosphate (SP supplementation on cycling 500 kJ (119.5 Kcal time trial (TT performance in female cyclists. Thirteen cyclists participated in a randomised, Latin-square design study where they completed four separate trials after ingesting either a placebo, or one of three different doses (25, 50 or 75 mg·kg-1 fat free mass: FFM of trisodium phosphate dodecahydrate which was split into four equal doses a day for six days. On the day after the loading phase, the TT was performed on a cycle ergometer. Serum phosphate blood samples were taken at rest both before and after each loading protocol, while a ~21 day washout period separated each loading phase. No significant differences in TT performance were observed between any of the supplementation protocols (p = 0.73 with average completion times for the 25, 50 or 75 mg·kg-1 FFM being, 42:21 ± 07:53, 40:55 ± 07:33 and 40:38 ± 07:20 min respectively, and 40:39 ± 07:51 min for the placebo. Likewise, average and peak power output did not significantly differ between trials (p = 0.06 and p = 0.46, respectively. Consequently, 500 kJ cycling TT performance was not different in any of the supplementation protocols in female cyclists.

  15. The effects of caffeinated "energy shots" on time trial performance.

    Science.gov (United States)

    Schubert, Matthew Mark; Astorino, Todd Anthony; Azevedo, John Leal

    2013-06-06

    An emerging trend in sports nutrition is the consumption of energy drinks and "energy shots". Energy shots may prove to be a viable pre-competition supplement for runners. Six male runners (mean ± SD age and VO2max: 22.5 ± 1.8 years and 69.1 ± 5.7 mL·kg-1·min-1) completed three trials [placebo (PLA; 0 mg caffeine), Guayakí Yerba Maté Organic Energy Shot™ (YM; 140 mg caffeine), or Red Bull Energy Shot™ (RB; 80 mg caffeine)]. Treatments were ingested following a randomized, placebo-controlled crossover design. Participants ran a five kilometer time trial on a treadmill. No differences (p > 0.05) in performance were detected with RB (17.55 ± 1.01 min) or YM ingestion (17.86 ± 1.59 min) compared to placebo (17.44 ± 1.25 min). Overall, energy shot ingestion did not improve time-trial running performance in trained runners.

  16. Analog-Computer Investigation of Effects of Friction and Preload on the Dynamic Longitudinal Characteristics of a Pilot-Airplane Combination

    Science.gov (United States)

    Crane, Harold L.

    1961-01-01

    With an electric analog computer, an investigation has been made of the effects of control frictions and preloads on the transient longitudinal response of a fighter airplane during abrupt small attitude corrections. The simulation included the airplane dynamics, powered control system, feel system, and a simple linearized pseudopilot. Control frictions at the stick pivot and at the servo valve as well as preloads of the stick and valve were considered individually and in combinations. It is believed that the results which are presented in the form of time histories and vector diagrams present a more detailed illustration of the effects of stray forces and compensating forces in the longitudinal control system than has previously been available. Consistent with the results of previous studies, the present results show that any of these four friction and preload forces caused some deterioration of the response. However, even a small amount of valve friction caused an oscillatory pitching response during which the phasing of the valve friction was such that it caused energy to be fed into the pitching oscillation of the air-plane. Of the other friction and preload forces which were considered, it was found that stick preload was close to 180 deg. out of phase with valve friction and thus could compensate in large measure for valve friction as long as the cycling of the stick encompassed the trim point. Either stick friction or valve preload provided a smaller stabilizing effect primarily through a reduction in the amplitude of the resultant force vector acting on the control system. Some data were obtained on the effects of friction when the damping or inertia of the control system or the pilot lag was varied.

  17. The accuracy of simulated indoor time trials utilizing a CompuTrainer and GPS data.

    Science.gov (United States)

    Peveler, Willard W

    2013-10-01

    The CompuTrainer is commonly used to measure cycling time trial performance in a laboratory setting. Previous research has demonstrated that the CompuTrainer tends toward underestimating power at higher workloads but provides reliable measures. The extent to which the CompuTrainer is capable of simulating outdoor time trials in a laboratory setting has yet to be examined. The purpose of this study was to examine the validity of replicating an outdoor time trial course indoors by comparing completion times between the actual time trial course and the replicated outdoor time trial course on the CompuTrainer. A global positioning system was used to collect data points along a local outdoor time trial course. Data were then downloaded and converted into a time trial course for the CompuTrainer. Eleven recreational to highly trained cyclists participated in this study. To participate in this study, subjects had to have completed a minimum of 2 of the local Cleves time trial races. Subjects completed 2 simulated indoor time trials on the CompuTrainer. Mean finishing times for the mean indoor performance trial (34.58 ± 8.63 minutes) were significantly slower in relation to the mean outdoor performance time (26.24 ± 3.23 minutes). Cyclists' finish times increased (performance decreased) by 24% on the indoor time trials in relation to the mean outdoor times. There were no significant differences between CompuTrainer trial 1 (34.77 ± 8.54 minutes) and CompuTrainer trial 1 (34.37 ± 8.76 minutes). Because of the significant differences in times between the indoor and outdoor time trials, meaningful comparisons of performance times cannot be made between the two. However, there were no significant differences found between the 2 CompuTrainer trials, and therefore the CompuTrainer can still be recommended for laboratory testing between trials.

  18. Dynamic preload indicators fail to predict fluid responsiveness in open-chest conditions

    NARCIS (Netherlands)

    de Waal, Eric E. C.; Rex, Steffen; Kruitwagen, Cas L. J. J.; Kalkman, Cor J.; Buhre, Wolfgang F.

    2009-01-01

    Objective: Dynamic preload indicators like pulse pressure variation (PPV) and stroke volume variation (SVV) are increasingly being used for optimizing cardiac preload since they have been demonstrated to predict fluid responsiveness in a variety of perioperative settings. However, in open-chest cond

  19. Novel approach for determining the optimal axial preload of a simulating rotary table spindle system

    Institute of Scientific and Technical Information of China (English)

    SHAN Xiao-biao; XIE Tao; CHEN Wei-shan

    2007-01-01

    This paper presents a new theoretical model to determine the optimal axial preload ora spindle system, for challenging the traditional method which relies heavily on experience of engineers. The axial preloading stiffness was treated as the sum of the spindle modal stiffness and the framework elastic stiffness, based on a novel concept that magnitude of preloads can be controlled by measuring the resonant frequency of a spindle system. By employing an example of a certain type of aircraft simulating rotary table, the modal stiffness was measured on the Agilent 35670A Dynamic Signal Analyzer by experimental modal analysis. The equivalent elastic stiffness was simulated by both finite element analysis in ANSYS(R) and a curve fitting in MATLAB(R). Results showed that the static preloading stiffness of the spindle was 7.2125×107 N/m, and that the optimal preloading force was 120.0848 N. Practical application proved the feasibility of our method.

  20. Gasification of Nickel-Preloaded Oil Palm Biomass with Air

    Directory of Open Access Journals (Sweden)

    Syed Shatir A. Syed-Hassan

    2016-10-01

    Full Text Available This study experimentally investigates the gasification of nickel-preloaded oil palm biomass as an alternative catalytic approach to produce clean syngas. To eliminate the use of catalyst support, nickel was added directly to the oil palm mesocarp fiber via ion-exchange using an aqueous solution of nickel nitrate. Nickel species was found to disperse very well on the biomass at a nano-scale dispersion. The presence of the finely dispersed nickels on biomass enhanced syngas production and reduced tar content in the producer gas during the air gasification of biomass. It is believed that nickel particles attached on the biomass and its char promote the catalytic cracking of tar on their surface and supply free radicals to the gas phase to enhance the radical-driven gas-phase reactions for the reforming of high molecular weight hydrocarbons. The unconsumed nickel-containing char shows great potential to be re-utilised as a catalyst to further enhance the destruction of tar components in the secondary tar reduction process. Copyright © 2016 BCREC GROUP. All rights reserved Received: 12nd September 2015; Revised: 10th January 2016; Accepted:16th January 2016 How to Cite: Syed-Hassan, S.S.A., Nor-Azemi, S. (2016. Gasification of Nickel-Preloaded Oil Palm Biomass with Air. Bulletin of Chemical Reaction Engineering & Catalysis, 11 (3: 262-272 (doi:10.9767/bcrec.11.3.566.262-272 Permalink/DOI: http://doi.org/10.9767/bcrec.11.3.566.262-272

  1. Effect of cyclic torsional preloading on cyclic fatigue resistance of ProTaper Next and Mtwo nickel–titanium instruments

    Directory of Open Access Journals (Sweden)

    Eugenio Pedullà

    2015-06-01

    Conclusions: Torsional preloads reduced the cyclic fatigue resistance of M-wire and conventional (as ProTaper Next and Mtwo NiTi rotary instruments except for Mtwo with 25% or 50% of torsional preloading.

  2. In vitro axial preload application during spine flexibility testing: towards reduced apparatus-related artefacts.

    Science.gov (United States)

    Cripton, P A; Bruehlmann, S B; Orr, T E; Oxland, T R; Nolte, L P

    2000-12-01

    Presently, there is little consensus about how, or even if, axial preload should be incorporated in spine flexibility tests in order to simulate the compressive loads naturally present in vivo. Some preload application methods are suspected of producing unwanted "artefact" forces as the specimen rotates and, in doing so, influencing the resulting kinematics. The objective of this study was to quantitatively compare four distinct types of preload which have roots in contemporary experimental practice. The specific quantities compared were the reaction moments and forces resulting at the intervertebral disc and specimen kinematics. The preload types incorporated increasing amounts of caudal constraint on the preload application vector ranging from an unconstrained dead-load arrangement to an apparatus that allowed the vector to follow rotations of the specimen. Six human cadaveric spine segments were tested (1-L1/L2, 3-L2/L3, 1-L3/L4 and 1-L4/L5). Pure moments were applied to the specimens with each of the four different types of compressive preload. Kinematic response was measured using an opto-electronic motion analysis system. A six-axis load cell was used to measure reaction forces and moments. Artefact reaction moments and shear forces were significantly affected by preload application method and magnitude. Unconstrained preload methods produced high artefact moments and low artefact shear forces while more constrained methods did the opposite. A mechanical trade-off is suggested by our results, whereby unwanted moment can only be prevented at the cost of shear force production. When comparing spine flexibility studies, caution should be exercised to ensure preload was applied in a similar manner for all studies. Unwanted moments or forces induced as a result of preload application method may render the comparison of two seemingly similar studies inappropriate.

  3. Real-time enrollment dashboard for multisite clinical trials

    Directory of Open Access Journals (Sweden)

    William A. Mattingly

    2015-10-01

    Conclusion: We have designed and implemented a visualization dashboard for managing multi-site clinical trial enrollment in two community acquired pneumonia studies. Information dashboards are useful for clinical trial management. They can be used in a standalone trial or can be included into a larger management system.

  4. The Proportion of Fixed Interval Trials to Probe Trials Affects Acquisition of the Peak Procedure Fixed Interval Timing Task

    OpenAIRE

    2007-01-01

    A common procedure for studying the ability of animals to time is the peak procedure. With the peak procedure animals are first trained on a fixed interval schedule (i.e., 30 seconds). After the animals have been well trained on the fixed interval schedule, probe trials are introduced. On probe trials the stimulus is presented longer (i.e., 90 seconds) and the animal does not receive reinforcement for responding. When animals are first presented with probe trials responding remains flat follo...

  5. Combined and interactive effects of interference fit and preloads on composite joints

    Institute of Scientific and Technical Information of China (English)

    Liu Longquan; Zhang Junqi; Chen Kunkun; Wang Hai

    2014-01-01

    The combined and interactive effects of the bolt-hole fit conditions and the preloads of the fasteners on the load carrying capacity of single-lap composite-to-titanium bolted joints have been investigated both experimentally and numerically. Quasi-static tests of the hybrid joints with different fit conditions are implemented, and a three dimensional finite element progressive failure analysis model is proposed to predict the influences of the bolt-hole fit conditions and fastener’s pre-loads on the mechanical behaviors of the joints. Based on the experimental validated simulation method, a multi-factor, mixed levels orthogonal design table and the analysis of variance method are used to arrange the simulation conditions and to further study the interactive effects of preloads and fit conditions. Through the analysis of the results, for the researched double bolt, single-lap composite-titanium joints, it is found that:the effects of both the interference fit and the preloads change from positive into negative mode with the increase of the interference fit values or preload values; appropriate bolt-hole fit conditions and preloads can improve the bolt-hole contact conditions of the loaded joints, and then retard the fiber failures around the fastener holes, and increase the load carrying capacity of the joints eventually; the interactive effect of the bolt-hole interference fit conditions and preloads cannot be ignored and the parameters need to be considered together and synthetically as the joints are being optimized.

  6. Probability distribution of von Mises stress in the presence of pre-load.

    Energy Technology Data Exchange (ETDEWEB)

    Segalman, Daniel Joseph; Field, Richard V.,; Reese, Garth M.

    2013-04-01

    Random vibration under preload is important in multiple endeavors, including those involving launch and re-entry. There are some methods in the literature to begin to address this problem, but there is nothing that accommodates the existence of preloads and the necessity of making probabilistic statements about the stress levels likely to be encountered. An approach to achieve to this goal is presented along with several simple illustrations.

  7. Preloaded Motorway Embankments:an environmentally sound solution for soft soil areas

    OpenAIRE

    1999-01-01

    Road construction, particularly involving soft soil replacement, draws very heavily on the scarce resources of sand and gravel. One environmentally appealing alternative to complete soft soil replacement is preloading where the sand/gravel materials may be re-used along the road alignment. The paper describes the first application of the method for motorways in connection with the completion of the Danish motorway infrastructure. To validate the feasibility of preloading an instrumented test ...

  8. Calorie anticipation alters food intake after low-caloric not high-caloric preloads.

    Science.gov (United States)

    Hogenkamp, P S; Cedernaes, J; Chapman, C D; Vogel, H; Hjorth, O C; Zarei, S; Lundberg, L S; Brooks, S J; Dickson, S L; Benedict, C; Schiöth, H B

    2013-08-01

    Cognitive factors and anticipation are known to influence food intake. The current study examined the effect of anticipation and actual consumption of food on hormone (ghrelin, cortisol, and insulin) and glucose levels, appetite and ad libitum intake, to assess whether changes in hormone levels might explain the predicted differences in subsequent food intake. During four breakfast sessions, participants consumed a yogurt preload that was either low caloric (LC: 180 kcal/300 g) or high caloric (HC: 530 kcal/300 g) and was provided with either consistent or inconsistent calorie information (i.e., stating the caloric content of the preload was low or high). Appetite ratings and hormone and glucose levels were measured at baseline (t = 0), after providing the calorie information about the preload (t = 20), after consumption of the preload (t = 40), and just before ad libitum intake (t = 60). Ad libitum intake was lower after HC preloads (as compared to LC preloads; P Intake after LC preloads was higher when provided with (consistent) LC information (467±254 kcal) as compared to (inconsistent) HC information (346±210 kcal), but intake after the HC preloads did not depend on the information provided (LC information: 290±178 kcal, HC information: 333±179 kcal; caloric load*information P = 0.03). Hormone levels did not respond in an anticipatory manner, and the post-prandial responses depended on actual calories consumed. These results suggest that both cognitive and physiological information determine food intake. When actual caloric intake was sufficient to produce physiological satiety, cognitive factors played no role; however, when physiological satiety was limited, cognitively induced satiety reduced intake to comparable levels. Copyright © 2012 The Obesity Society.

  9. Influence of pre-load coefficient of TPJBs with even number pads on shaft lateral vibration

    Institute of Scientific and Technical Information of China (English)

    2001-01-01

    For a rotating machine with one or more tilting pad journal bearings (TPJBs), it is acommon state that pad-to-journal assembling clearances are uneven in one bearing, or inconsis-tent relationship of assembling clearances are encountered among all the bearings. Consideringthe structural characteristics of a TPJB, a concept named as "pad pair pre-load coefficient" corre-sponding to bearing pre-load coefficient is proposed. Firstly, the influence of bearing pre-load coef-ficient and pad pair pre-load coefficient on shaft vibration in a Jeffcot rotor is analyzed. Then takingNo.1 unit with two TPJBs in Guangzhou pumped storage power plant (GPSP) as an example, theinfluence of inconsistent relationship of the two bearing pre-load coefficients on shaft vibration isanalyzed. The results show that variety of one bearing pre-load coefficient will only influence vibra-tion amplitude, not involving the shape of shaft center orbit. But variety of one or more "pad pairpre-load coefficient" will influence not only vibration amplitude, but also the shape of orbit-whichwill be turned from a circle to an ellipse. By investigating variation characteristics of shape andvibration amplitude of orbits at the TPJBs, some theoretical bases will be supplied for diagnosingthe condition of the unit bearings.

  10. Age-related differences in the neural correlates of trial-to-trial variations of reaction time

    Directory of Open Access Journals (Sweden)

    Nancy E. Adleman

    2016-06-01

    Full Text Available Intra-subject variation in reaction time (ISVRT is a developmentally-important phenomenon that decreases from childhood through young adulthood in parallel with the development of executive functions and networks. Prior work has shown a significant association between trial-by-trial variations in reaction time (RT and trial-by-trial variations in brain activity as measured by the blood-oxygenated level-dependent (BOLD response in functional magnetic resonance imaging (fMRI studies. It remains unclear, however, whether such “RT-BOLD” relationships vary with age. Here, we determined whether such trial-by-trial relationships vary with age in a cross-sectional design. We observed an association between age and RT-BOLD relationships in 11 clusters located in visual/occipital regions, frontal and parietal association cortex, precentral/postcentral gyrus, and thalamus. Some of these relationships were negative, reflecting increased BOLD associated with decreased RT, manifesting around the time of stimulus presentation and positive several seconds later. Critically for present purposes, all RT-BOLD relationships increased with age. Thus, RT-BOLD relationships may reflect robust, measurable changes in the brain-behavior relationship across development.

  11. An automated method to control preload by compensation for stress relaxation in spontaneously contracting, isometric rat mesenteric lymphatics.

    Science.gov (United States)

    Davis, Michael J; Lane, Megan M; Scallan, Joshua P; Gashev, Anatoliy A; Zawieja, David C

    2007-08-01

    Our objective was to devise a system to automatically correct for stress relaxation of isometric rat mesenteric lymphatics (90-120 microm, ID). Stress relaxation is a particular problem in isometric studies of highly distensible vessels and is evident as a time-dependent, secondary decline in force after an abrupt length increase. Because the phasic contraction pattern of lymphatics is exquisitely sensitive to changes in preload, stress relaxation makes stable contraction patterns difficult to achieve and analyze. A DMT wire myograph was modified to accommodate an Inchworm piezo stack in series with a standard micrometer drive to permit automated control of vessel caliber/force. The force output of the myograph was digitized and computer algorithms were devised to servo control force by changing vessel diameter. The system was tested on passive lymphatics, passive small veins, and lymphatics exhibiting spontaneous force transients. The software was designed to temporarily disable servo control during a spontaneous force transient. For both active and passive lymphatics, stable preloads were very well maintained, indicating that the system was adequately compensating for stress relaxation. The method works well with isometric rat mesenteric lymphatics without disturbing spontaneous activity. It should be applicable to arterial, venous, and lymphatic vessels (80-500 microm in diameter) isolated from other tissues and species.

  12. Preloading with L-BPA, L-tyrosine and L-DOPA enhances the uptake of [(18)F]FBPA in human and mouse tumour cell lines.

    Science.gov (United States)

    Wingelhofer, Bettina; Kreis, Katharina; Mairinger, Severin; Muchitsch, Viktoria; Stanek, Johann; Wanek, Thomas; Langer, Oliver; Kuntner, Claudia

    2016-12-01

    Aim of this study was to investigate if cellular [(18)F]FBPA uptake can be increased upon preloading with amino acids. [(18)F]FBPA uptake was assessed in HuH-7, CaCo-2 and B16-F1 cells pretreated with different concentrations or incubation times of L-BPA, L-tyrosine or L-DOPA. Without preloading, highest uptake of [(18)F]FBPA was observed in B16-F1 cells, followed by CaCo-2 cells and HuH-7 cells. In all cell lines higher [(18)F]FBPA accumulation (up to 1.65-fold) was obtained with increasing L-BPA, L-DOPA and L-tyrosine concentrations.

  13. Females have greater left ventricular twist mechanics than males during acute reductions to preload.

    Science.gov (United States)

    Williams, Alexandra M; Shave, Rob E; Stembridge, Mike; Eves, Neil D

    2016-07-01

    Compared to males, females have smaller left ventricular (LV) dimensions and volumes, higher ejection fractions (EF), and higher LV longitudinal and circumferential strain. LV twist mechanics determine ventricular function and are preload-dependent. Therefore, the sex differences in LV structure and myocardial function may result in different mechanics when preload is altered. This study investigated sex differences in LV mechanics during acute challenges to preload. With the use of conventional and speckle-tracking echocardiography, LV structure and function were assessed in 20 males (24 ± 6.2 yr) and 20 females (23 ± 3.1 yr) at baseline and during progressive levels of lower body negative pressure (LBNP). Fourteen participants (8 males, 6 females) were also assessed following a rapid infusion of saline. LV end-diastolic volume, end-systolic volume, stroke volume (SV), and EF were reduced in both groups during LBNP (P mechanics following saline infusion. Females have larger LV twist and a faster untwisting velocity than males during large reductions to preload, supporting that females have a greater reliance on LV twist mechanics to maintain SV during severe reductions to preload.

  14. A technique for monitoring fast tuner piezoactuator preload forces for superconducting rf cavities

    Energy Technology Data Exchange (ETDEWEB)

    Pischalnikov, Y.; Branlard, J.; Carcagno, R.; Chase, B.; Edwards, H.; Orris, D.; Makulski, A.; McGee, M.; Nehring, R.; Poloubotko, V.; Sylvester, C.; /Fermilab

    2007-06-01

    The technology for mechanically compensating Lorentz Force detuning in superconducting RF cavities has already been developed at DESY. One technique is based on commercial piezoelectric actuators and was successfully demonstrated on TESLA cavities [1]. Piezo actuators for fast tuners can operate in a frequency range up to several kHz; however, it is very important to maintain a constant static force (preload) on the piezo actuator in the range of 10 to 50% of its specified blocking force. Determining the preload force during cool-down, warm-up, or re-tuning of the cavity is difficult without instrumentation, and exceeding the specified range can permanently damage the piezo stack. A technique based on strain gauge technology for superconducting magnets has been applied to fast tuners for monitoring the preload on the piezoelectric assembly. The design and testing of piezo actuator preload sensor technology is discussed. Results from measurements of preload sensors installed on the tuner of the Capture Cavity II (CCII)[2] tested at FNAL are presented. These results include measurements during cool-down, warmup, and cavity tuning along with dynamic Lorentz force compensation.

  15. Statistical Frequency-Dependent Analysis of Trial-to-Trial Variability in Single Time Series by Recurrence Plots.

    Science.gov (United States)

    Tošić, Tamara; Sellers, Kristin K; Fröhlich, Flavio; Fedotenkova, Mariia; Beim Graben, Peter; Hutt, Axel

    2015-01-01

    For decades, research in neuroscience has supported the hypothesis that brain dynamics exhibits recurrent metastable states connected by transients, which together encode fundamental neural information processing. To understand the system's dynamics it is important to detect such recurrence domains, but it is challenging to extract them from experimental neuroscience datasets due to the large trial-to-trial variability. The proposed methodology extracts recurrent metastable states in univariate time series by transforming datasets into their time-frequency representations and computing recurrence plots based on instantaneous spectral power values in various frequency bands. Additionally, a new statistical inference analysis compares different trial recurrence plots with corresponding surrogates to obtain statistically significant recurrent structures. This combination of methods is validated by applying it to two artificial datasets. In a final study of visually-evoked Local Field Potentials in partially anesthetized ferrets, the methodology is able to reveal recurrence structures of neural responses with trial-to-trial variability. Focusing on different frequency bands, the δ-band activity is much less recurrent than α-band activity. Moreover, α-activity is susceptible to pre-stimuli, while δ-activity is much less sensitive to pre-stimuli. This difference in recurrence structures in different frequency bands indicates diverse underlying information processing steps in the brain.

  16. Preload Analysis of Screw Bolt Joints on the First Wall Graphite Tiles in EAST

    Institute of Scientific and Technical Information of China (English)

    曹磊; 宋云涛

    2012-01-01

    The first wall in the Experimental Advanced Superconducting Tokamak (EAST) used graphite tiles to withstand high thermal energy. The graphite tiles are mounted on the heat sink using screw bolts which have been preloaded to produce a clamp force. The clamp force is very important to keep the graphite tiles tightly on the surface of the heat sink so that the heat flux crosses this contacting surface in a small thermal resistor. Without the clamp force, the small gap between the graphite tiles and the heat sink will make it impossible for thermal power to be carried away by cooling water. Some bolts may even fall off with the loss of clamp force. From the mathematical models, the loss process of the clamp force has been studied. Research results explain how the different thermal expansions of three members of the screw joint makes the clamp force decrease to zero under temperature rise and external force, and how the stiffness affects the relation between the clamp force and temperature. The research also gives the critical temperature at which the clamp force can remain above zero. Analysis results indicate that the current screw joints are almost destined to lose their clamp force during the running time of EAST, so the bolt joints should be redesigned in order to improve its reliability.

  17. EVALUATION OF TROQUE VS CLOSURE BOLT PRELOAD FOR A TYPICAL CONTAINMENT VESSEL UNDER SERVICE CONDITIONS

    Energy Technology Data Exchange (ETDEWEB)

    Smith, A.

    2010-02-16

    Radioactive material package containment vessels typically employ bolted closures of various configurations. Closure bolts must retain the lid of a package and must maintain required seal loads, while subjected to internal pressure, impact loads and vibration. The need for insuring that the specified preload is achieved in closure bolts for radioactive materials packagings has been a continual subject of concern for both designers and regulatory reviewers. The extensive literature on threaded fasteners provides sound guidance on design and torque specification for closure bolts. The literature also shows the uncertainty associated with use of torque to establish preload is typically between 10 and 35%. These studies have been performed under controlled, laboratory conditions. The ability to insure required preload in normal service is, consequently, an important question. The study described here investigated the relationship between indicated torque and resulting bolt load for a typical radioactive materials package closure using methods available under normal service conditions.

  18. The Influence of Preload on the Work of Angular Contact Ball Bearings

    Directory of Open Access Journals (Sweden)

    Kaczor Jarosław

    2016-09-01

    Full Text Available Optimum values of preload can be achieved in well-tried constructions and then applied in similar structures. For new structures, it is recommended to calculate the preload force and to test the correctness of calculation by means of experiments. In practice it may be necessary to introduce corrections, because not all real work parameters can be precisely known. Credibility of calculations depends, first of all, on the consistence between the assumptions concerning temperature conditions during work and elastic deformations of cooperating elements – first of all of a holder – and the real work conditions. The aim of the study is to determine how preload influences the work of a system of angular ball bearings, in relation to durability of bearing, moment of friction and rigidity of the bearing.

  19. Time-Lag Bias in Trials of Pediatric Antidepressants: A Systematic Review and Meta-Analysis

    Science.gov (United States)

    Reyes, Magdalena M.; Panza, Kaitlyn E.; Martin, Andres; Bloch, Michael H.

    2011-01-01

    Objective: To determine whether there is evidence of a time-lag bias in the publication of pediatric antidepressant trials. Method: We conducted a meta-analysis of published and unpublished randomized placebo-controlled trials of serotonin reuptake inhibitors (SRIs) in subjects less than 18 years of age with major depressive disorder. Our main…

  20. Time-Lag Bias in Trials of Pediatric Antidepressants: A Systematic Review and Meta-Analysis

    Science.gov (United States)

    Reyes, Magdalena M.; Panza, Kaitlyn E.; Martin, Andres; Bloch, Michael H.

    2011-01-01

    Objective: To determine whether there is evidence of a time-lag bias in the publication of pediatric antidepressant trials. Method: We conducted a meta-analysis of published and unpublished randomized placebo-controlled trials of serotonin reuptake inhibitors (SRIs) in subjects less than 18 years of age with major depressive disorder. Our main…

  1. Neural responses to the mechanical parameters of a high velocity, low amplitude spinal manipulation: effect of preload parameters

    Science.gov (United States)

    Reed, William. R.; Long, Cynthia R.; Kawchuk, Gregory N.; Pickar, Joel G.

    2014-01-01

    Objective The purpose of this study was to determine how the preload that precedes a high velocity low amplitude spinal manipulation (HVLA-SM) affects muscle spindle input from lumbar paraspinal muscles both during and after the HVLA-SM. Methods Primary afferent activity from muscle spindles in lumbar paraspinal muscles were recorded from the L6 dorsal root in anesthetized cats. HVLA-SM of the L6 vertebra was preceded either by no preload or by systematic changes in the preload magnitude, duration, and the presence or absence of a downward incisural point (DIP). Immediate effects of preload on muscle spindle responses to the HVLA-SM were determined by comparing mean instantaneous discharge frequencies (MIF) during the HVLA-SM’s thrust phase with baseline. Longer lasting effects of preload on spindle responses to the HVLA-SM were determined by comparing MIF during slow ramp and hold movement of the L6 vertebra before and following the HVLA-SM. Results The smaller compared to the larger preload magnitude and the longer compared to the shorter preload duration significantly increased (P=0.02 and P=0.04) respectively) muscle spindle responses during the HVLA-SM thrust. The absence of preload had the greatest effect on the change in MIF. Interactions between preload magnitude, duration and DIP often produced statistically significant but arguably physiologically modest changes in the passive signaling properties of the muscle spindle following the manipulation. Conclusion Because preload parameters in this animal model were shown to affect neural responses to an HVLA-SM, preload characteristics should be taken into consideration when judging this intervention’s therapeutic benefit in both clinical efficacy studies and in clinical practice. PMID:24387888

  2. No difference found in time to publication by statistical significance of trial results: a methodological review

    Science.gov (United States)

    Jefferson, L; Cooper, E; Hewitt, C; Torgerson, T; Cook, L; Tharmanathan, P; Cockayne, S; Torgerson, D

    2016-01-01

    Objective Time-lag from study completion to publication is a potential source of publication bias in randomised controlled trials. This study sought to update the evidence base by identifying the effect of the statistical significance of research findings on time to publication of trial results. Design Literature searches were carried out in four general medical journals from June 2013 to June 2014 inclusive (BMJ, JAMA, the Lancet and the New England Journal of Medicine). Setting Methodological review of four general medical journals. Participants Original research articles presenting the primary analyses from phase 2, 3 and 4 parallel-group randomised controlled trials were included. Main outcome measures Time from trial completion to publication. Results The median time from trial completion to publication was 431 days (n = 208, interquartile range 278–618). A multivariable adjusted Cox model found no statistically significant difference in time to publication for trials reporting positive or negative results (hazard ratio: 0.86, 95% CI 0.64 to 1.16, p = 0.32). Conclusion In contrast to previous studies, this review did not demonstrate the presence of time-lag bias in time to publication. This may be a result of these articles being published in four high-impact general medical journals that may be more inclined to publish rapidly, whatever the findings. Further research is needed to explore the presence of time-lag bias in lower quality studies and lower impact journals. PMID:27757242

  3. Effects of preparation time and trial type probability on performance of anti- and pro-saccades.

    Science.gov (United States)

    Pierce, Jordan E; McDowell, Jennifer E

    2016-02-01

    Cognitive control optimizes responses to relevant task conditions by balancing bottom-up stimulus processing with top-down goal pursuit. It can be investigated using the ocular motor system by contrasting basic prosaccades (look toward a stimulus) with complex antisaccades (look away from a stimulus). Furthermore, the amount of time allotted between trials, the need to switch task sets, and the time allowed to prepare for an upcoming saccade all impact performance. In this study the relative probabilities of anti- and pro-saccades were manipulated across five blocks of interleaved trials, while the inter-trial interval and trial type cue duration were varied across subjects. Results indicated that inter-trial interval had no significant effect on error rates or reaction times (RTs), while a shorter trial type cue led to more antisaccade errors and faster overall RTs. Responses following a shorter cue duration also showed a stronger effect of trial type probability, with more antisaccade errors in blocks with a low antisaccade probability and slower RTs for each saccade task when its trial type was unlikely. A longer cue duration yielded fewer errors and slower RTs, with a larger switch cost for errors compared to a short cue duration. Findings demonstrated that when the trial type cue duration was shorter, visual motor responsiveness was faster and subjects relied upon the implicit trial probability context to improve performance. When the cue duration was longer, increased fixation-related activity may have delayed saccade motor preparation and slowed responses, guiding subjects to respond in a controlled manner regardless of trial type probability.

  4. Which laboratory variable is related with time trial performance time in the Tour de France?

    Science.gov (United States)

    Lucia, A; Hoyos, J; Perez, M; Santalla, A; Earnest, C; Chicharro, J

    2004-01-01

    Objective: To investigate the relationship between several physiological variables that can be easily obtained during cycle ergometer gradual testing (for example, peak power output (Wpeak), VO2max, or ventilatory threshold (VT)) and actual (>50 km) time trials (TT) time performance during the Tour de France. Methods: We collected data in professional cyclists from the first TT of the 1998 Tour de France (TT1, 58 km distance; n = 6 cyclists) and the first (TT2, 56.5 km; n = 5) and second TT of the 1999 Tour de France (TT3, 57 km; n = 5). Results: A negative relationship was found between power output (W) at VT (VTWatt) and TT final time (s) in TT1 (r = –0.864; p = 0.026; standard error of estimate (SEE) of 73 s; and 95% confidence limits (95% CL) –0.98; –0.18), TT2 (r = –0.77; p = 0.27; SEE of 139 s; and 95% CL –0.98; 0.35), and TT3 (r = –0.923; p = 0.025; SEE of 94 s; and 95% CL –1.00; –0.22). Conclusions: Actual performance in long TT during the Tour de France (>50 km distance, performed after at least 1–2 weeks of continuous competition), in which some cumulative fatigue inevitably occurs, is related, at least in part, to the power output that elicits the VT. No other routine physiological variable (for example, VO2max or Wpeak) is related to performance in this type of event. PMID:15388555

  5. Stimulation of Methanol Degradation in UASB Reactors: In Situ Versus Pre-Loading Cobalt on Anaerobic Granular Sludge

    NARCIS (Netherlands)

    Zandvoort, M.H.; Gieteling, J.; Lettinga, G.; Lens, P.N.L.

    2004-01-01

    The effect of pre-loading and in situ loading of cobalt onto a cobalt-limited granular sludge on the performance of methanol fed bioreactors was investigated. One upflow anaerobic sludge bed (UASB) reactor was inoculated with cobalt pre-loaded sludge (24h; 30degreesC; 1 mM CoCl2) and a second UASB w

  6. Stimulation of Methanol Degradation in UASB Reactors: In Situ Versus Pre-Loading Cobalt on Anaerobic Granular Sludge

    NARCIS (Netherlands)

    Zandvoort, M.H.; Gieteling, J.; Lettinga, G.; Lens, P.N.L.

    2004-01-01

    The effect of pre-loading and in situ loading of cobalt onto a cobalt-limited granular sludge on the performance of methanol fed bioreactors was investigated. One upflow anaerobic sludge bed (UASB) reactor was inoculated with cobalt pre-loaded sludge (24h; 30degreesC; 1 mM CoCl2) and a second UASB

  7. Dynamic Fracture Properties of Rocks Subjected to Static Pre-load Using Notched Semi-circular Bend Method

    Science.gov (United States)

    Chen, Rong; Li, Kang; Xia, Kaiwen; Lin, Yuliang; Yao, Wei; Lu, Fangyun

    2016-10-01

    A dynamic load superposed on a static pre-load is a key problem in deep underground rock engineering projects. Based on a modified split Hopkinson pressure bar test system, the notched semi-circular bend (NSCB) method is selected to investigate the fracture initiation toughness of rocks subjected to pre-load. In this study, a two-dimensional ANSYS finite element simulation model is developed to calculate the dimensionless stress intensity factor. Three groups of NSCB specimen are tested under a pre-load of 0, 37 and 74 % of the maximum static load and with the loading rate ranging from 0 to 60 GPa m1/2 s-1. The results show that under a given pre-load, the fracture initiation toughness of rock increases with the loading rate, resembling the typical rate dependence of materials. Furthermore, the dynamic rock fracture toughness decreases with the static pre-load at a given loading rate. The total fracture toughness, defined as the sum of the dynamic fracture toughness and initial stress intensity factor calculated from the pre-load, increases with the pre-load at a given loading rate. An empirical equation is used to represent the effect of loading rate and pre-load force, and the results show that this equation can depict the trend of the experimental data.

  8. Field-measured drag area is a key correlate of level cycling time trial performance

    Directory of Open Access Journals (Sweden)

    James E. Peterman

    2015-08-01

    Full Text Available Drag area (Ad is a primary factor determining aerodynamic resistance during level cycling and is therefore a key determinant of level time trial performance. However, Ad has traditionally been difficult to measure. Our purpose was to determine the value of adding field-measured Ad as a correlate of level cycling time trial performance. In the field, 19 male cyclists performed a level (22.1 km time trial. Separately, field-determined Ad and rolling resistance were calculated for subjects along with projected frontal area assessed directly (AP and indirectly (Est AP. Also, a graded exercise test was performed to determine $\\dot {V}{O}_{2}$V̇O2 peak, lactate threshold (LT, and economy. $\\dot {V}{O}_{2}$V̇O2 peak ($\\mathrm{l}~\\min ^{-1}$lmin−1 and power at LT were significantly correlated to power measured during the time trial (r = 0.83 and 0.69, respectively but were not significantly correlated to performance time (r = − 0.42 and −0.45. The correlation with performance time improved significantly (p < 0.05 when these variables were normalized to Ad. Of note, Ad alone was better correlated to performance time (r = 0.85, p < 0.001 than any combination of non-normalized physiological measure. The best correlate with performance time was field-measured power output during the time trial normalized to Ad (r = − 0.92. AP only accounted for 54% of the variability in Ad. Accordingly, the correlation to performance time was significantly lower using power normalized to AP (r = − 0.75 or Est AP (r = − 0.71. In conclusion, unless normalized to Ad, level time trial performance in the field was not highly correlated to common laboratory measures. Furthermore, our field-measured Ad is easy to determine and was the single best predictor of level time trial performance.

  9. Mountain time trial in handcycling : exercise intensity and predictors of race time in people with spinal cord injury

    NARCIS (Netherlands)

    de Groot, Sonja; Postma, Karin; van Vliet, Linda; Timmermans, Remco; Valent, L J M

    Study design: Cross-sectional analyses. Objectives: To analyze exercise intensity during a mountain time trial in handcycling and to determine predictors of race time. Setting: Eight Dutch rehabilitation centers and Austrian mountain. Methods: Forty participants with spinal cord injury (SCI; high

  10. Augmenting performance feedback does not affect 4 km cycling time-trials in the heat.

    Science.gov (United States)

    Waldron, Mark; Villerius, Vincent; Murphy, Aron

    2015-01-01

    We compared the effects of (1) accurate and (2) surreptitiously augmented performance feedback on power output and physiological responses to a 4000 m time-trial in the heat. Nine cyclists completed a baseline (BaseL) 4000 m time-trial in ambient temperatures of 30°C, followed by two further 4000 m time-trials at the same temperature, randomly assigning the participants to an accurate (ACC; accurate feedback of baseline) or deceived (DEC; 2% increase above baseline) feedback group. The total power output (PO) and aerobic (Paer) and anaerobic (Pan) contributions were determined at 0.4 km stages during the time-trials, alongside measurements of rectal (Trec) and skin (Tskin) temperatures. There were no differences (P > 0.05) in any of the variables between BaseL, ACC and DEC, despite increases (P 0.05) between feedback condition and time-trial stage. Providing surreptitiously augmented performance feedback to well-trained cyclists did not alter their performance or physiological responses to a 4000 m time-trial in a hot environment. The assumed influence of augmented performance feedback was nullified in the heat, perhaps reflecting a central down-regulation of exercise intensity in response to an increased body temperature.

  11. Introducing a Third Timed Up & Go Test Trial Improves Performances of Hospitalized and Community-Dwelling Older Individuals.

    Science.gov (United States)

    Bloch, Mette L; Jønsson, Line R; Kristensen, Morten T

    Originally, the Timed Up & Go (TUG) test was described as including a practice trial before a timed trial, but recent studies in individuals with hip fracture have reported that performance improved with a third trial and that high intertester reliability was achieved when the fastest of 3 timed trials was used. Thus, the fastest of 3 TUG trials is recommended when testing individuals with hip fracture. To our knowledge, no study has examined the number of trials needed to achieve performance stability on the TUG test (defined as no further improvement on subsequent trials) when performed by older individuals without hip fracture. The aim of the study, therefore, was to examine whether a third TUG trial is faster than either of 2 TUG trials conducted according to standardized TUG instructions and whether the fastest of 3 trials is the most appropriate measure to apply in hospitalized and community-dwelling older individuals. Eighty-two participants (50 from a geriatric hospital unit and 32 from an outpatient geriatric center; 52 women, 30 men) with a mean (SD) age of 83.6 (7.9) years were included in this cross-sectional study. All participants (except one from the hospital unit) performed 3 TUG trials, as fast as safely possible on the same day, and separated by up to 1-minute pauses. A rollator (4-wheeled rolling walker) was used as a standardized walking aid in the geriatric hospital unit, whereas participants used their normal walking aid (if any) in the outpatient geriatric center. The fastest trial was trial 3 for 47 (57%), trial 2 for 25 (31%), and trial 1 for 10 (12%). Repeated-measures analyses of variance with Bonferroni corrections showed that TUG times improved from trial 1 to trial 3 (P timed trials was significantly (P < .001) faster than the other 2 trials. We suggest that the fastest of the 3 TUG trials is recorded instead of the second trial in both hospitalized and community-dwelling older individuals.

  12. Effect of preload alternations on a new Doppler echocardiographic index of combined systolic and diastolic performance

    DEFF Research Database (Denmark)

    Møller, J E; Poulsen, S H; Egstrup, K

    1999-01-01

    The objective of the study was to assess the effect of preload alternations on a nongeometric Doppler index of combined systolic and diastolic myocardial performance (MPI). Doppler echocardiography was performed during Valsalva maneuver, passive leg lifting, and after sublingual administration of...

  13. Is the performance of acceleromyography improved with preload and normalization? A comparison with mechanomyography

    DEFF Research Database (Denmark)

    Claudius, Casper; Skovgaard, Lene Theil; Viby-Mogensen, Jørgen

    2009-01-01

    BACKGROUND: Many studies have indicated that acceleromyography and mechanomyography cannot be used interchangeably. To improve the agreement between the two methods, it has been suggested to use a preload and to refer all train-of-four (TOF) ratios to the control TOF (normalization) when using ac...

  14. Prediction of fluid responsiveness by dynamic preload indices in patients undergoing major hepatic resection

    NARCIS (Netherlands)

    Vos, Jaap Jan; Kalmar, A.F.; Struys, Michel; Wietasch, Johann; Hendriks, Herman; Scheeren, Thomas

    2012-01-01

    Background and Goal of the Study:  Dynamic preload indices, based on the arterial pressure waveform (APW; semi-invasive) or on the plethysmographic waveform (PW; non-invasive) are increasingly used to assess fluid responsiveness. We compared the ability of the commercially available APW-based stroke

  15. Prediction of fluid responsiveness by dynamic preload indices in patients undergoing major hepatic resection

    NARCIS (Netherlands)

    Vos, J. J.; Kalmar, A.F.; Struys, M. M. R. F.; Wietasch, J. K. G.; Hendriks, H. G. D.; Scheeren, T. W. L.

    2012-01-01

    Background and Goal of the Study:  Dynamic preload indices, based on the arterial pressure waveform (APW; semi-invasive) or on the plethysmographic waveform (PW; non-invasive) are increasingly used to assess fluid responsiveness. We compared the ability of the commercially available APW-based stroke

  16. Evaluating Protocol Lifecycle Time Intervals in HIV/AIDS Clinical Trials

    Science.gov (United States)

    Schouten, Jeffrey T.; Dixon, Dennis; Varghese, Suresh; Cope, Marie T.; Marci, Joe; Kagan, Jonathan M.

    2014-01-01

    Background Identifying efficacious interventions for the prevention and treatment of human diseases depends on the efficient development and implementation of controlled clinical trials. Essential to reducing the time and burden of completing the clinical trial lifecycle is determining which aspects take the longest, delay other stages, and may lead to better resource utilization without diminishing scientific quality, safety, or the protection of human subjects. Purpose In this study we modeled time-to-event data to explore relationships between clinical trial protocol development and implementation times, as well as identify potential correlates of prolonged development and implementation. Methods We obtained time interval and participant accrual data from 111 interventional clinical trials initiated between 2006 and 2011 by NIH’s HIV/AIDS Clinical Trials Networks. We determined the time (in days) required to complete defined phases of clinical trial protocol development and implementation. Kaplan-Meier estimates were used to assess the rates at which protocols reached specified terminal events, stratified by study purpose (therapeutic, prevention) and phase group (pilot/phase I, phase II, and phase III/ IV). We also examined several potential correlates to prolonged development and implementation intervals. Results Even though phase grouping did not determine development or implementation times of either therapeutic or prevention studies, overall we observed wide variation in protocol development times. Moreover, we detected a trend toward phase III/IV therapeutic protocols exhibiting longer developmental (median 2 ½ years) and implementation times (>3years). We also found that protocols exceeding the median number of days for completing the development interval had significantly longer implementation. Limitations The use of a relatively small set of protocols may have limited our ability to detect differences across phase groupings. Some timing effects

  17. Approximately determining preloading duration considering creep%考虑蠕变时预压期的近似确定方法

    Institute of Scientific and Technical Information of China (English)

    胡亚元

    2012-01-01

    As the secondary consolidation settlement was not taken into account in classical preloading theory and the flaw sometimes happened that the critical consolidation degree was bigger than 100% considering secondary consolidation settlement in Johnson's method, an approximate formula of preloading duration under a single-stage sudden loading was proposed. During the derivation of this approximate formula, Bjerrum's equal-time creep diagram and Yin-Graham equivalent-time rheological model are used and Zeng Guo-xi's approximate formula of consolidation degree is employed. So the approximate formula can be able to avoid the flaw of Johnson's method, and analyze the effects of soft subsoil's consolidation coefficient, creep coefficient, swelling index, surcharge pressure ratio, allowable post-construction settlement and preconsolidation time on preloading duration. Research results show that when surcharge pressure ratio is relatively smaller, preloading duration decays with the power growth of surcharge pressure ratio. An increase in surcharge pressure ratio can obviously make preloading duration short. When surcharge pressure ratio become bigger, preloading duration slowly decays with the growth of surcharge pressure ratio. An increase in surcharge pressure ratio can only make preloading duration a little decrease.%针对经典预压理论无法考虑次固结沉降以及考虑次固结沉降的Johnson法有时会出现临界固结度超过100%的错误,提出预压荷载一次骤然施加完毕后预压持续时间的近似计算公式.在推导该近似公式过程中,利用Bjerrum等时蠕变图和Yin-Graham等效时间线流变模型,采用曾国熙近似固结度计算公式,因此该近似公式能够克服Johnson法的缺陷,分析软基固结系数、蠕变系数、回弹指数、超固结比、工后允许沉降和预固结时间对预压工期的影响.研究表明:当预压超载较小时,预压持续时间随着超载比的增加呈幂函数趋势减少,

  18. Multiple linear regression to estimate time-frequency electrophysiological responses in single trials.

    Science.gov (United States)

    Hu, L; Zhang, Z G; Mouraux, A; Iannetti, G D

    2015-05-01

    Transient sensory, motor or cognitive event elicit not only phase-locked event-related potentials (ERPs) in the ongoing electroencephalogram (EEG), but also induce non-phase-locked modulations of ongoing EEG oscillations. These modulations can be detected when single-trial waveforms are analysed in the time-frequency domain, and consist in stimulus-induced decreases (event-related desynchronization, ERD) or increases (event-related synchronization, ERS) of synchrony in the activity of the underlying neuronal populations. ERD and ERS reflect changes in the parameters that control oscillations in neuronal networks and, depending on the frequency at which they occur, represent neuronal mechanisms involved in cortical activation, inhibition and binding. ERD and ERS are commonly estimated by averaging the time-frequency decomposition of single trials. However, their trial-to-trial variability that can reflect physiologically-important information is lost by across-trial averaging. Here, we aim to (1) develop novel approaches to explore single-trial parameters (including latency, frequency and magnitude) of ERP/ERD/ERS; (2) disclose the relationship between estimated single-trial parameters and other experimental factors (e.g., perceived intensity). We found that (1) stimulus-elicited ERP/ERD/ERS can be correctly separated using principal component analysis (PCA) decomposition with Varimax rotation on the single-trial time-frequency distributions; (2) time-frequency multiple linear regression with dispersion term (TF-MLRd) enhances the signal-to-noise ratio of ERP/ERD/ERS in single trials, and provides an unbiased estimation of their latency, frequency, and magnitude at single-trial level; (3) these estimates can be meaningfully correlated with each other and with other experimental factors at single-trial level (e.g., perceived stimulus intensity and ERP magnitude). The methods described in this article allow exploring fully non-phase-locked stimulus-induced cortical

  19. Separation of time-based and trial-based accounts of the partial reinforcement extinction effect.

    Science.gov (United States)

    Bouton, Mark E; Woods, Amanda M; Todd, Travis P

    2014-01-01

    Two appetitive conditioning experiments with rats examined time-based and trial-based accounts of the partial reinforcement extinction effect (PREE). In the PREE, the loss of responding that occurs in extinction is slower when the conditioned stimulus (CS) has been paired with a reinforcer on some of its presentations (partially reinforced) instead of every presentation (continuously reinforced). According to a time-based or "time-accumulation" view (e.g., Gallistel and Gibbon, 2000), the PREE occurs because the organism has learned in partial reinforcement to expect the reinforcer after a larger amount of time has accumulated in the CS over trials. In contrast, according to a trial-based view (e.g., Capaldi, 1967), the PREE occurs because the organism has learned in partial reinforcement to expect the reinforcer after a larger number of CS presentations. Experiment 1 used a procedure that equated partially and continuously reinforced groups on their expected times to reinforcement during conditioning. A PREE was still observed. Experiment 2 then used an extinction procedure that allowed time in the CS and the number of trials to accumulate differentially through extinction. The PREE was still evident when responding was examined as a function of expected time units to the reinforcer, but was eliminated when responding was examined as a function of expected trial units to the reinforcer. There was no evidence that the animal responded according to the ratio of time accumulated during the CS in extinction over the time in the CS expected before the reinforcer. The results thus favor a trial-based account over a time-based account of extinction and the PREE. This article is part of a Special Issue entitled: Associative and Temporal Learning.

  20. How many research nurses for how many clinical trials in an oncology setting? Definition of the Nursing Time Required by Clinical Trial-Assessment Tool (NTRCT-AT).

    Science.gov (United States)

    Milani, Alessandra; Mazzocco, Ketti; Stucchi, Sara; Magon, Giorgio; Pravettoni, Gabriella; Passoni, Claudia; Ciccarelli, Chiara; Tonali, Alessandra; Profeta, Teresa; Saiani, Luisa

    2017-02-01

    Few resources are available to quantify clinical trial-associated workload, needed to guide staffing and budgetary planning. The aim of the study is to describe a tool to measure clinical trials nurses' workload expressed in time spent to complete core activities. Clinical trials nurses drew up a list of nursing core activities, integrating results from literature searches with personal experience. The final 30 core activities were timed for each research nurse by an outside observer during daily practice in May and June 2014. Average times spent by nurses for each activity were calculated. The "Nursing Time Required by Clinical Trial-Assessment Tool" was created as an electronic sheet that combines the average times per specified activities and mathematic functions to return the total estimated time required by a research nurse for each specific trial. The tool was tested retrospectively on 141 clinical trials. The increasing complexity of clinical research requires structured approaches to determine workforce requirements. This study provides a tool to describe the activities of a clinical trials nurse and to estimate the associated time required to deliver individual trials. The application of the proposed tool in clinical research practice could provide a consistent structure for clinical trials nursing workload estimation internationally.

  1. Mental Toughness Moderates Social Loafing in Cycle Time-Trial Performance

    Science.gov (United States)

    Haugen, Tommy; Reinboth, Michael; Hetlelid, Ken J.; Peters, Derek M.; Høigaard, Rune

    2016-01-01

    Purpose: The purpose of this study was to determine if mental toughness moderated the occurrence of social loafing in cycle time-trial performance. Method: Twenty-seven men (M[subscript age] = 17.7 years, SD = 0.6) completed the Sport Mental Toughness Questionnaire prior to completing a 1-min cycling trial under 2 conditions: once with individual…

  2. Design, Assembly and Preloading of Ball Bearings for Space Applications- Lessons Learned and Guidelines for Future Success

    Science.gov (United States)

    Videra, E.; Lebreton, C.; Lewis, S. D.; Gaillard, L.

    2013-09-01

    The use of ball bearings in the space industry is commonplace, with a broad range of applications from the most precise pointing mechanisms to extreme long -life and performance-demanding reaction wheels and simpler single-shot devices where precision, performance and life may be less difficult to achieve. Though most application developments are ultimately successful, the lessons learned from the incorrect implementation of ball bearings are, usually for understandable commercial reasons, not widely distributed - but often extremely valuable for industry.The organizations contributing to this paper have an unprecedentedly clear view of numerous spacecraft applications, both successful and otherwise, together with many years of experience in design, handling, lubricating, preloading and testing ball bearings for space applications.In order to help the space community to avoid design or handling errors in future, ESA has mandated bearing manufacturer ADR, and the European Space Tribology Laboratory (ESTL) to create a useful guideline which summarises both best practice and a distillation of the lessons learned from many programs.This paper presents a selection of the more valuable and generally applicable lessons learned by these organizations in the last 30-40 years together with an overview of the recently published guideline document itself [1] which embodies this experience and contains recommendations concerning ball bearing selection, design and conceptual rules and recommendations for assembly, preloading and verification testing.The novelty of this paper comes from the broad range of experiences and applications, both good and bad that the organisations concerned have observed and the publication (for the first time) of guidelines for use by the space mechanisms community in Europe.

  3. Introducing a Third Timed Up & Go Test Trial Improves Performances of Hospitalized and Community-Dwelling Older Individuals

    DEFF Research Database (Denmark)

    Bloch, Mette L; Jønsson, Line R; Kristensen, Morten T

    2016-01-01

    BACKGROUND AND PURPOSE: Originally, the Timed Up & Go (TUG) test was described as including a practice trial before a timed trial, but recent studies in individuals with hip fracture have reported that performance improved with a third trial and that high intertester reliability was achieved when...

  4. Micro-Randomized Trials: An Experimental Design for Developing Just-in-Time Adaptive Interventions

    Science.gov (United States)

    Klasnja, Predrag; Hekler, Eric B.; Shiffman, Saul; Boruvka, Audrey; Almirall, Daniel; Tewari, Ambuj; Murphy, Susan A.

    2015-01-01

    Objective This paper presents an experimental design, the micro-randomized trial, developed to support optimization of just-in-time adaptive interventions (JITAIs). JITAIs are mHealth technologies that aim to deliver the right intervention components at the right times and locations to optimally support individuals’ health behaviors. Micro-randomized trials offer a way to optimize such interventions by enabling modeling of causal effects and time-varying effect moderation for individual intervention components within a JITAI. Methods The paper describes the micro-randomized trial design, enumerates research questions that this experimental design can help answer, and provides an overview of the data analyses that can be used to assess the causal effects of studied intervention components and investigate time-varying moderation of those effects. Results Micro-randomized trials enable causal modeling of proximal effects of the randomized intervention components and assessment of time-varying moderation of those effects. Conclusions Micro-randomized trials can help researchers understand whether their interventions are having intended effects, when and for whom they are effective, and what factors moderate the interventions’ effects, enabling creation of more effective JITAIs. PMID:26651463

  5. Real-time monitoring for human clinical trials

    Energy Technology Data Exchange (ETDEWEB)

    Harker, Y.D. [Idaho National Engineering Lab., Idaho Falls, ID (United States)

    1995-11-01

    On August 3-4, 1994, an INEL team made measurements related to a real-time monitoring system for use on the epithermal beam facility at the BMRR. BNL has installed two fission chambers in front of the beam collimator, which are to monitor the beam coming from the reactor. These two monitors are located with one just above the 16-cm dia. front aperture and the other is just below. The fission chambers contain depleted uranium, but because of the small amount of U-235 present, they respond to thermal and near thermal neutrons rather than fast neutrons. This feature combined with their relatively small size (0.6 cm dia x 4 cm long) makes them very good monitors in the BMRR epithermal neutron beam. The INEL team worked with H.B. Lui (BNL) in performing initial tests of these monitors and established the settings to achieve stable operation. The main purpose of the measurement studies was to establish a basis for a monitoring method that tracks the dose the patient is receiving rather than the neutron fluence being delivered down the beam line.

  6. Effect of time of day on performance, hormonal and metabolic response during a 1000-M cycling time trial.

    Directory of Open Access Journals (Sweden)

    Alan Lins Fernandes

    Full Text Available The aim of this study was to determine the effect of time of day on performance, pacing, and hormonal and metabolic responses during a 1000-m cycling time-trial. Nine male, recreational cyclists visited the laboratory four times. During the 1st visit the participants performed an incremental test and during the 2nd visit they performed a 1000-m cycling familiarization trial. On the 3rd and 4th visits, the participants performed a 1000-m TT at either 8 am or 6 pm, in randomized, repeated-measures, crossover design. The time to complete the time trial was lower in the evening than in the morning (88.2±8.7 versus 94.7±10.9 s, respectively, p0.05, but the norepinephrine response to the exercise was increased in the morning (+46%, p0.05. Our findings suggest that performance was improved in the evening, and it was accompanied by an improved hormonal and metabolic milieu.

  7. Effect of inhaled terbutaline on substrate utilization and 300-kcal time trial performance

    DEFF Research Database (Denmark)

    Kalsen, Anders; Hostrup, Morten; Karlsson, Sebastian

    2014-01-01

    In a randomized double-blind crossover design, we investigated the effect of the beta2-agonist terbutaline on endurance performance and substrate utilization in nine moderately trained males (maximum oxygen uptake (VO2max): 58.9±3.1 mL min(-1) kg(-1)). Subjects performed 60 min of submaximal...... exercise (65-70% of VO2max) immediately followed by a 300-kcal time trial with inhalation of either terbutaline (TER) or placebo (PLA). Pulmonary gas exchange was measured during the submaximal exercise and muscle biopsies were collected before and after the exercise bouts. Time trial performance...

  8. Potential Risk Analysis of Tailings Dam under Preloading Condition and Its Countermeasures

    Directory of Open Access Journals (Sweden)

    Shuren Wang

    2015-01-01

    Full Text Available It is very important for mine production safety to ensure the stability of the tailings dam. Taking a flatland tailings pond as the background, a threedimensional computational model was built based on a tailings dam under mullock heap preloading condition. Considering the current operating water level conditions, a liquid-solid coupling analysis of the model was conducted.The deformation characteristics of the tailings dam were revealed during successive preloading at the front of the dam. The safety factor and the potential slide face of the tailings dam were calculated under different conditions using the strength reduction method. The results show that the tailings dam in its current condition is basically stable, but if the mullock heap continues to be heightened, the tailings dam will become unstable. Therefore, in order to limit the height of the mullock heap, establishing a monitor and early warning mechanism are put forward to ensure mine production safety.

  9. Static Absolute Force Measurement for Preloaded Piezoelements Used for Active Lorentz Force Detuning System

    CERN Document Server

    Sekalski, S P; Sekalski, S P

    2004-01-01

    To reach high gradients in pulsed operation of superconducting (SC) cavities an active Lorentz force detuning compensation system is needed. For this system a piezoelement can be used as an actuator (other option is a magnetostrictive device). To guarantee the demanded lifetime of the active element, the proper preload force adjustment is necessary. To determine this parameter an absolute force sensor is needed which will be able to operate at cryogenic temperatures. Currently, there is no calibrated commercial available sensor, which will be able to measure the static force in such an environment. The authors propose to use a discovered phenomenon to estimate the preload force applied to the piezoelement. The principle of the proposed solution based on a shape of impedance curve, which changes with the value of applied force. Especially, the position of resonances are monitored. No need of specialized force sensor and measurement in-situ are additional advantages of proposed method.

  10. Automatic control of the preload in adaptive friction drives of chemical production machines

    Science.gov (United States)

    Balakin, P. D.

    2017-08-01

    Being based on the principle of providing the systems with adaptation property to the real parameters and operational condition, the energy effective mechanical system constructed on the base of friction gear with automated preload is offered and this allows keeping mechanical efficiency value adequate transforming drive path to in the terms of multimode operation. This is achieved by integrated control loop, operating on the basis of the laws of motion with the energy of the main power flow by changing automatically the kinematic dimension of the section and, hence, the value of preload in the friction contact. The given ratios of forces and deformations in the control loop are required at the stage of conceptual design to determine design dimensions of power transmission elements with new properties.

  11. Calorie Anticipation Alters Food Intake After Low-Caloric but Not High-Caloric Preloads

    OpenAIRE

    Hogenkamp, Pleunie; Cedernaes, Jonathan; Chapman, Colin; Vogel, Heike; Hjorth, Olof; Zarei, Sanaz; Lundberg, Lina; Brooks, Samantha; Dickson, Suzanne; Benedict, Christian; Schiöth, Helgi

    2013-01-01

    Objective Cognitive factors and anticipation are known to influence food intake. The current study examined the effect of anticipation and actual consumption of food on hormone (ghrelin, cortisol, and insulin) and glucose levels, appetite and ad libitum intake, to assess whether changes in hormone levels might explain the predicted differences in subsequent food intake. Design and Methods During four breakfast sessions, participants consumed a yogurt preload that was either low caloric (LC: 1...

  12. Deconstructing alcohol use on a night out in England: promotions, preloading and consumption.

    Science.gov (United States)

    McClatchley, Kirstie; Shorter, Gillian W; Chalmers, Jenny

    2014-07-01

    To examine alcohol consumed during a drinking event (a single drinking occasion) by those attending public house/on-trade establishments on nights with standard pricing and nights with promotional prices. Data (n = 425) were collected in an ecological momentary assessment over eight nights in two locations (Midlands and London) on both promotional and standard (Saturday) nights. Multiple regression was used to predict event alcohol consumption by sex, age, type of night, alcohol preloading behaviour, marital and employment status, education, Alcohol Use Disorders Identification Test alcohol consumption questions separately or total AUDIT-C and social group size. Mean (UK) units consumed were 11.8 (London) and 14.4 (Midlands). In London, consumption was similar on promotional and standard nights, but in the Midlands, standard night consumption was three units higher. Preloading was reported by 30%; more common on standard nights. Regression analyses revealed being male, preloading and past-year total AUDIT-C were associated with higher event consumption. However, when AUDIT-C questions were added separately, being a standard night was associated with increased event consumption and different AUDIT-C questions were significantly associated with event consumption in each location. Event consumption reflected heavy episodic drinking and was influenced by price. Promotional night consumption either matched standard Saturday night consumption or was slightly lower. In London, there was a significant preference for drinking at least one promotional beverage on promotional nights. On standard nights, consumption was over a wider range of venues, and preloading with off-trade alcohol was more likely. © 2014 Australasian Professional Society on Alcohol and other Drugs.

  13. Mouth Rinsing with Maltodextrin Solutions Fails to Improve Time Trial Endurance Cycling Performance in Recreational Athletes.

    Science.gov (United States)

    Kulaksız, Tuğba Nilay; Koşar, Şükran Nazan; Bulut, Suleyman; Güzel, Yasemin; Willems, Marcus Elisabeth Theodorus; Hazir, Tahir; Turnagöl, Hüseyin Hüsrev

    2016-05-09

    The carbohydrate (CHO) concentration of a mouth rinsing solution might influence the CHO sensing receptors in the mouth, with consequent activation of brain regions involved in reward, motivation and regulation of motor activity. The purpose of the present study was to examine the effects of maltodextrin mouth rinsing with different concentrations (3%, 6% and 12%) after an overnight fast on a 20 km cycling time trial performance. Nine recreationally active, healthy males (age: 24 ± 2 years; V ˙ O 2 m a x : 47 ± 5 mL·kg(-1)·min(-1)) participated in this study. A double-blind, placebo-controlled randomized study was conducted. Participants mouth-rinsed every 2.5 km for 5 s. Maltodextrin mouth rinse with concentrations of 3%, 6% or 12% did not change time to complete the time trial and power output compared to placebo (p > 0.05). Time trial completion times were 40.2 ± 4.0, 40.1 ± 3.9, 40.1 ± 4.4, and 39.3 ± 4.2 min and power output 205 ± 22, 206 ± 25, 210 ± 24, and 205 ± 23 W for placebo, 3%, 6%, and 12% maltodextrin conditions, respectively. Heart rate, lactate, glucose, and rating of perceived exertion did not differ between trials (p > 0.05). In conclusion, mouth rinsing with different maltodextrin concentrations after an overnight fast did not affect the physiological responses and performance during a 20 km cycling time trial in recreationally active males.

  14. Mouth Rinsing with Maltodextrin Solutions Fails to Improve Time Trial Endurance Cycling Performance in Recreational Athletes

    Science.gov (United States)

    Kulaksız, Tuğba Nilay; Koşar, Şükran Nazan; Bulut, Suleyman; Güzel, Yasemin; Willems, Marcus Elisabeth Theodorus; Hazir, Tahir; Turnagöl, Hüseyin Hüsrev

    2016-01-01

    The carbohydrate (CHO) concentration of a mouth rinsing solution might influence the CHO sensing receptors in the mouth, with consequent activation of brain regions involved in reward, motivation and regulation of motor activity. The purpose of the present study was to examine the effects of maltodextrin mouth rinsing with different concentrations (3%, 6% and 12%) after an overnight fast on a 20 km cycling time trial performance. Nine recreationally active, healthy males (age: 24 ± 2 years; V˙O2max: 47 ± 5 mL·kg−1·min−1) participated in this study. A double-blind, placebo-controlled randomized study was conducted. Participants mouth-rinsed every 2.5 km for 5 s. Maltodextrin mouth rinse with concentrations of 3%, 6% or 12% did not change time to complete the time trial and power output compared to placebo (p > 0.05). Time trial completion times were 40.2 ± 4.0, 40.1 ± 3.9, 40.1 ± 4.4, and 39.3 ± 4.2 min and power output 205 ± 22, 206 ± 25, 210 ± 24, and 205 ± 23 W for placebo, 3%, 6%, and 12% maltodextrin conditions, respectively. Heart rate, lactate, glucose, and rating of perceived exertion did not differ between trials (p > 0.05). In conclusion, mouth rinsing with different maltodextrin concentrations after an overnight fast did not affect the physiological responses and performance during a 20 km cycling time trial in recreationally active males. PMID:27171108

  15. Mouth Rinsing with Maltodextrin Solutions Fails to Improve Time Trial Endurance Cycling Performance in Recreational Athletes

    Directory of Open Access Journals (Sweden)

    Tuğba Nilay Kulaksız

    2016-05-01

    Full Text Available The carbohydrate (CHO concentration of a mouth rinsing solution might influence the CHO sensing receptors in the mouth, with consequent activation of brain regions involved in reward, motivation and regulation of motor activity. The purpose of the present study was to examine the effects of maltodextrin mouth rinsing with different concentrations (3%, 6% and 12% after an overnight fast on a 20 km cycling time trial performance. Nine recreationally active, healthy males (age: 24 ± 2 years; V ˙ O 2 m a x : 47 ± 5 mL·kg−1·min−1 participated in this study. A double-blind, placebo-controlled randomized study was conducted. Participants mouth-rinsed every 2.5 km for 5 s. Maltodextrin mouth rinse with concentrations of 3%, 6% or 12% did not change time to complete the time trial and power output compared to placebo (p > 0.05. Time trial completion times were 40.2 ± 4.0, 40.1 ± 3.9, 40.1 ± 4.4, and 39.3 ± 4.2 min and power output 205 ± 22, 206 ± 25, 210 ± 24, and 205 ± 23 W for placebo, 3%, 6%, and 12% maltodextrin conditions, respectively. Heart rate, lactate, glucose, and rating of perceived exertion did not differ between trials (p > 0.05. In conclusion, mouth rinsing with different maltodextrin concentrations after an overnight fast did not affect the physiological responses and performance during a 20 km cycling time trial in recreationally active males.

  16. Timing of insertion of levonorgestrel-releasing intrauterine system : a randomised controlled trial

    NARCIS (Netherlands)

    van der Heijden, Pahh; Geomini, Pmaj; Herman, M C; Veersema, S; Bongers, M Y

    OBJECTIVE: The objective was to assess whether patient-perceived pain during the insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) depends on the timing during the menstrual cycle. DESIGN: A stratified two-armed non-inferiority randomised controlled trial. SETTING: Large

  17. Exact solutions of the time-fractional Fisher equation by using modified trial equation method

    Science.gov (United States)

    Tandogan, Yusuf Ali; Bildik, Necdet

    2016-06-01

    In this study, modified trial equation method has been proposed to obtain precise solutions of nonlinear fractional differential equation. Using the modified test equation method, we obtained some new exact solutions of the time fractional nonlinear Fisher equation. The obtained results are classified as a soliton solution, singular solutions, rational function solutions and periodic solutions.

  18. Syllable-Timed Speech Treatment for School-Age Children Who Stutter: A Phase I Trial

    Science.gov (United States)

    Andrews, Cheryl; O'Brian, Sue; Harrison, Elisabeth; Onslow, Mark; Packman, Ann; Menzies, Ross

    2012-01-01

    Purpose: This clinical trial determined the outcomes of a simple syllable-timed speech (STS) treatment for school-age children who stutter. Method: Participants were 10 children, ages 6-11 years, who stutter. Treatment involved training the children and their parents to use STS at near normal speech rates. The technique was practiced in the clinic…

  19. Pacing Strategy, Muscle Fatigue and Technique in 1500m Speed Skating and Cycling Time-Trials

    NARCIS (Netherlands)

    Stoter, Inge K; MacIntosh, Brian R; Fletcher, Jared R; Pootz, Spencer; Zijdewind, Inge; Hettinga, Florentina J

    2016-01-01

    PURPOSE: To evaluate pacing behavior and peripheral and central contributions to muscle fatigue in 1500m speed skating and cycling time-trials, when a faster or slower start is instructed. METHODS: Nine speed skaters and nine cyclists, all competing at regional or national level, performed two 1500m

  20. Ad-libitum drinking and performance during a 40-km cycling time trial in the heat

    NARCIS (Netherlands)

    Berkulo, M.A.R.; Bol, S.; Levels, K.; Lamberts, R.P.; Daanen, H.A.M.; Noakes, T.D.

    2016-01-01

    The aim of this study was to investigate if drinking ad-libitum can counteract potential negative effects of a hypohydrated start caused by fluid restriction during a 40-km time trial (TT) in the heat. Twelve trained males performed one 40-km cycling TT euhydrated (EU: no water during the TT) and tw

  1. Flat and uphill climb time trial performance prediction in elite amateur cyclists.

    Science.gov (United States)

    Antón, M M; Izquierdo, M; Ibáñez, J; Asiain, X; Mendiguchía, J; Gorostiaga, E M

    2007-04-01

    The aim of this study was to determine physiological, anthropometric, biomechanical and hormonal variables related to road flat and uphill climb performance. Eighteen elite level amateur road cyclists (21.1 +/- 3.8 yrs), homogeneous with regard to time trial performance (coefficient of variation: 2.9-5.2 %), were measured for frontal area (FA), maximal strength, power, cross-sectional area of the quadriceps femoris muscle and basal serum concentrations of total testosterone (TT), free testosterone (FT) and cortisol (C). Maximal (W (max)) and submaximal workload were measured during a progressive discontinuous maximal cycling laboratory test, and two all-out time trial performance tests (duration range: 1049-1251 s) were also conducted outdoors on two separate days: a 14-km flat road (average gradient of 0.2 %) and a 6.7-km uphill climb (average gradient of 6 %). Significant negative correlations (p climb trial performance time correlated significantly (p climb time trial performance is associated with maximal workload normalized to body mass, as well as with an increased anabolic-androgenic activity.

  2. A comparison of caffeine versus pseudoephedrine on cycling time-trial performance.

    Science.gov (United States)

    Spence, Angela L; Sim, Marc; Landers, Grant; Peeling, Peter

    2013-10-01

    Both caffeine (CAF) and pseudoephedrine (PSE) are proposed to be central nervous system stimulants. However, during competition, CAF is a permitted substance, whereas PSE is a banned substance at urinary levels >150 μg · ml(-1). As a result, this study aimed to compare the effect of CAF versus PSE use on cycling time trial (TT) performance to explore whether the legal stimulant was any less ergogenic than the banned substance. Here, 10 well-trained male cyclists or triathletes were recruited for participation. All athletes were required to attend the laboratory on four separate occasions--including a familiarization trial and three experimental trials, which required participants to complete a simulated 40 km (1,200 kJ) cycling TT after the ingestion of either 200 mg CAF, 180 mg PSE or a nonnutritive placebo (PLA). The results showed that the total time taken and the mean power produced during each TT was not significantly different (p > .05) between trials, despite a 1.3% faster overall time (~57 s) after CAF consumption. Interestingly, the time taken to complete the second half of the TT was significantly faster (p < .05) in CAF as compared with PSE (by 99 s), with magnitude based inferences suggesting a 91% beneficial effect of CAF during the second half of the TT. This investigation further confirms the ergogenic benefits of CAF use during TT performances and further suggests this legal CNS stimulant has a better influence than a supra-therapeutic dose of PSE.

  3. Effect of heat and heat acclimatization on cycling time trial performance and pacing

    DEFF Research Database (Denmark)

    Racinais, Sebastien; Périard, Julien D; Karlsen, Anders;

    2015-01-01

    PURPOSE: To determine the effects of heat-acclimatization on performance and pacing during outdoor cycling time-trials (TT, 43.4km) in the heat. METHODS: Nine cyclists performed 3 TTs in hot ambient conditions (TTH, ∼37ºC) on the first (TTH-1), sixth (TTH-2) and fourteenth (TTH-3) days of trainin...

  4. Single trial time-frequency domain analysis of error processing in post-traumatic stress disorder.

    Science.gov (United States)

    Clemans, Zachary A; El-Baz, Ayman S; Hollifield, Michael; Sokhadze, Estate M

    2012-09-13

    Error processing studies in psychology and psychiatry are relatively common. Event-related potentials (ERPs) are often used as measures of error processing, two such response-locked ERPs being the error-related negativity (ERN) and the error-related positivity (Pe). The ERN and Pe occur following committed error in reaction time tasks as low frequency (4-8 Hz) electroencephalographic (EEG) oscillations registered at the midline fronto-central sites. We created an alternative method for analyzing error processing using time-frequency analysis in the form of a wavelet transform. A study was conducted in which subjects with PTSD and healthy control completed a forced-choice task. Single trial EEG data from errors in the task were processed using a continuous wavelet transform. Coefficients from the transform that corresponded to the theta range were averaged to isolate a theta waveform in the time-frequency domain. Measures called the time-frequency ERN and Pe were obtained from these waveforms for five different channels and then averaged to obtain a single time-frequency ERN and Pe for each error trial. A comparison of the amplitude and latency for the time-frequency ERN and Pe between the PTSD and control group was performed. A significant group effect was found on the amplitude of both measures. These results indicate that the developed single trial time-frequency error analysis method is suitable for examining error processing in PTSD and possibly other psychiatric disorders.

  5. Analysis and Effect of Projection Welding Preload Changing under Position Control Mode%位控模式下的凸焊预压力变化分析及影响

    Institute of Scientific and Technical Information of China (English)

    曹园园; 沈景凤; 瞿亚浩; 邓新平; 郑乐辉

    2015-01-01

    研究了凸焊设备的位控模式和预压力参数波动原因,量化分析了压力参数变化范围;采用定电流和时间参数改变电极压力参数的方法进行了凸焊实验,使用微电脑拉力试验机测试焊点焊接强度,基于实验结果用MATLAB拟合预压力与焊点强度的高次曲线。基于拟合曲线确定实验电流、时间参数下的最佳预压力,结合实验拟合曲线和量化的压力参数浮动范围得出压力浮动造成的焊点结合强度降低范围;提出转矩控制方式控制预压力,以消除电极压力浮动造成的焊点质量不稳定。%The preload of the automatic projection welding equipment under position control mode changes over time and affects the stability of the welding quality .The position control mode of the welding equipment and the reasons of pressure fluctuations were studied;the range of preload was calculated;with current and time parameters fixed and preload changed , experiments were conducted ,then welding strength was tested by micro tensile testing machine;curves of preload and bonding strength were fitted with MATLAB based on the results of experiments .Under the fixed current and time conditions ,the best welding preload was found according to the fitting curve ,and the reduce of the bonding strength was determined too ;at last ,the torque control mode was proposed to eliminate the unstable welding quality caused by the change of preload .

  6. The effect of preload/meal energy density on energy intake in a subsequent meal: A systematic review and meta-analysis.

    Science.gov (United States)

    Rouhani, Mohammad Hossein; Surkan, Pamela J; Azadbakht, Leila

    2017-08-01

    To conduct a systematic review and meta-analysis of the effects of preload/meal energy density on energy intake in a subsequent meal(s). Multiple databases were searched for studies published through December 2016 on the effects of preload/meal energy density on energy intake in a subsequent meal(s). We extracted information on mean energy intake in a subsequent meal(s) and on variables that could contribute to between-subject heterogeneity. Forty and Thirty nine eligible studies were identified for our systematic review and meta-analysis, respectively. The meta-analysis showed that preload/meal energy density did not affect energy intake in a subsequent meal(s) (95% CI:-21.21, 21.29). As heterogeneity was remarkable among studies, we stratified the studies by intervention type into "meal" or "preload" classifications. In the "preload" subgroup, studies used either fixed energy or fixed weight preloads. The results reveal that in comparison to a high energy-dense (HED) preload, consuming a low energy-dense (LED) preload with same weight resulted in higher energy intake in a subsequent meal (95% CI: 9.72, 56.19). On the other hand, decreased energy intake was observed after consuming an LED preload compared to after consumption of an HED preload with same energy content (95% CI: -138.71, -57.33). In the "meal" subgroup, studies were categorized by different subsequent meal (i.e., "afternoon or evening", "lunch" and "dinner or post-dinner"). Meta-analysis showed that an LED meal resulted in more energy intake only in afternoon or evening meals (95% CI: 14.82, 31.22). In summary, the current analysis revealed that we can restrict the energy intake by consuming an LED preload. Moreover, consuming an LED preload could favorably affect preload+meal energy intake. Copyright © 2016. Published by Elsevier Ltd.

  7. Effect of different aerodynamic time trial cycling positions on muscle activation and crank torque.

    Science.gov (United States)

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

    2016-05-01

    To reduce air resistance, time trial cyclists and triathletes lower their torso angle. The aim of this study was to investigate the effect of lowering time trial torso angle positions on muscle activation patterns and crank torque coordination. It was hypothesized that small torso angles yield a forward shift of the muscle activation timing and crank torque. Twenty-one trained cyclists performed three exercise bouts at 70% maximal aerobic power in a time trial position at three different torso angles (0°, 8°, and 16°) at a fixed cadence of 85 rpm. Measurements included surface electromyography, crank torques and gas exchange. A significant increase in crank torque range and forward shift in peak torque timing was found at smaller torso angles. This relates closely with the later onset and duration of the muscle activation found in the gluteus maximus muscle. Torso angle effects were only observed in proximal monoarticular muscles. Moreover, all measured physiological variables (oxygen consumption, breathing frequency, minute ventilation) were significantly increased with lowering torso angle and hence decreased the gross efficiency. The findings provide support for the notion that at a cycling intensity of 70% maximal aerobic power, the aerodynamic gains outweigh the physiological/biomechanical disadvantages in trained cyclists.

  8. Long term ingestion of a preload containing fructo-oligosaccharide or guar gum decreases fat mass but not food intake in mice.

    Science.gov (United States)

    Hadri, Zouheyr; Chaumontet, Catherine; Fromentin, Gilles; Even, Patrick C; Darcel, Nicolas; Bouras, Abdelkader Dilmi; Tomé, Daniel; Rasoamanana, Rojo

    2015-08-01

    Fermentable dietary fibre such as fructo-oligosaccharide and viscous dietary fibers such as guar gum and alginate affect energy homeostasis. The goal of this study was to compare the impact of long term intake of these three dietary fibers on food intake, meal pattern, body weight and fat accumulation in mice. Over a period of 3weeks, the mice were fed daily with a preload containing 32mg of fructo-oligosaccharide or alginate or 13mg of guar gum. Food intake and body weight were monitored weekly, while meal patterns, adiposity and the expression of hypothalamic neuropeptide genes were evaluated at the end of the study period. The 3 dietary fibers produced a similar decrease in total daily food intake (14 to 22%) at the end of the first week, and this effect disappeared over time. The 3 dietary fibers induced a slight variation in satiation parameters. Body weight and expression of hypothalamic neuropeptide genes were not affected by any of the treatment. Preload of fructo-oligosaccharide and guar gum induced a similar and substantial decrease in the development of adiposity (17% and 14%, respectively), while alginate had no effect. Our results demonstrate mainly that the inhibitory effect of dietary fiber on food intake is lost over time, and that guar gum limits fat storage.

  9. Time regained: when people stop a physical activity program, how does their time use change? A randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Sjaan Gomersall

    Full Text Available The aim of this study was to investigate how previously inactive adults who had participated in a structured, partly supervised 6-week exercise program restructured their time budgets when the program ended. Using a randomised controlled trial design, 129 previously inactive adults were recruited and randomly allocated to one of three groups: a Moderate or Extensive six-week physical activity intervention (150 and 300 additional minutes of exercise per week, respectively or a Control group. Additional physical activity was accumulated through both group and individual exercise sessions with a wide range of activities. Use of time and time spent in energy expenditure zones was measured using a computerised 24-h self-report recall instrument, the Multimedia Activity Recall for Children and Adults, and accelerometry at baseline, mid- and end-program and at 3- and 6-months follow up. At final follow up, all significant changes in time use domains had returned to within 20 minutes of baseline levels (Physical Activity 1-2 min/d, Active Transport 3-9 min/d, Self-Care 0-2 min/d, Television/Videogames 13-18 min/d in the Moderate and Extensive group, relative to Controls, respectively, p > 0.05. Similarly, all significant changes in time spent in the moderate energy expenditure zone had returned to within 1-3 min/d baseline levels (p > 0.05, however time spent in vigorous physical activity according to accelerometry estimates remained elevated, although the changes were small in magnitude (1 min/d in the Moderate and Extensive groups, relative to Controls, p = 0.01. The results of this study demonstrate strong recidivist patterns in physical activity, but also in other aspects of time use. In designing and determining the effectiveness of exercise interventions, future studies would benefit from considering the whole profile of time use, rather than focusing on individual activities,Australian New Zealand Clinical Trials Registry ACTRN12610000248066.

  10. Outcomes of Descemet Stripping Endothelial Keratoplasty Using Eye Bank-Prepared Preloaded Grafts.

    Science.gov (United States)

    Palioura, Sotiria; Colby, Kathryn

    2017-01-01

    To evaluate the feasibility of Descemet stripping endothelial keratoplasty using grafts preloaded by an eye bank in a commercially available insertion device. In this retrospective case series, a series of 35 eyes in 34 consecutive patients who underwent Descemet stripping endothelial keratoplasty for Fuchs endothelial dystrophy or previously failed full-thickness grafts at a single tertiary care center from March 2013 to March 2014 was included. The donor tissue had undergone pre-lamellar dissection, trephination, and loading into EndoGlide Ultrathin inserters at the Lions Eye Institute for Transplant and Research (Tampa, FL) and was shipped overnight in Optisol GS to the surgeon (K.C.). Surgery was performed within 24 hours from tissue preparation and loading by the eye bank. Donor and recipient characteristics, endothelial cell density (ECD), best-corrected visual acuity, and central corneal thickness were recorded. The main outcome measures were intraoperative and postoperative complications and ECD loss at 3, 6, and 12 months. One primary graft failure (2.8%), 2 rebubblings (5.7%), and 1 graft rejection (2.8%) occurred. Mean preoperative donor ECD was 2821 ± 199 cells/mm. Six months postoperatively, the mean endothelial cell loss was 25.3% ± 17.2% (n = 32), which remained stable at 1 year (31.5% ± 17.9%, n = 32). Mean best-corrected visual acuity improved from 20/100 preoperatively to 20/25 at a mean follow-up of 1 year (n = 32). Mean central corneal thickness was reduced from 711 ± 110 μm to 638 ± 66 μm at the last follow-up visit. Donor graft tissue preloaded by an eye bank can be used successfully for endothelial keratoplasty. Preloading reduces intraoperative tissue manipulation.

  11. Variability of single trial brain activation predicts fluctuations in reaction time.

    Science.gov (United States)

    Bender, Stephan; Banaschewski, Tobias; Roessner, Veit; Klein, Christoph; Rietschel, Marcella; Feige, Bernd; Brandeis, Daniel; Laucht, Manfred

    2015-03-01

    Brain activation stability is crucial to understanding attention lapses. EEG methods could provide excellent markers to assess neuronal response variability with respect to temporal (intertrial coherence) and spatial variability (topographic consistency) as well as variations in activation intensity (low frequency variability of single trial global field power). We calculated intertrial coherence, topographic consistency and low frequency amplitude variability during target P300 in a continuous performance test in 263 15-year-olds from a cohort with psychosocial and biological risk factors. Topographic consistency and low frequency amplitude variability predicted reaction time fluctuations (RTSD) in a linear model. Higher RTSD was only associated with higher psychosocial adversity in the presence of the homozygous 6R-10R dopamine transporter haplotype. We propose that topographic variability of single trial P300 reflects noise as well as variability in evoked cortical activation patterns. Dopaminergic neuromodulation interacted with environmental and biological risk factors to predict behavioural reaction time variability.

  12. Preload dependence of new Doppler techniques limits their utility for left ventricular diastolic function assessment in hemodialysis patients.

    Science.gov (United States)

    Ie, Eric H Y; Vletter, Wim B; ten Cate, Folkert J; Nette, Robert W; Weimar, Willem; Roelandt, Jos R T C; Zietse, Robert

    2003-07-01

    Left ventricular (LV) hypertrophy leads to diastolic dysfunction. Standard Doppler transmitral and pulmonary vein (PV) flow velocity measurements are preload dependent. New techniques such as mitral annulus velocity by Doppler tissue imaging (DTI) and LV inflow propagation velocity measured from color M-mode have been proposed as relatively preload-independent measurements of diastolic function. These parameters were studied before and after hemodialysis (HD) with ultrafiltration to test their potential advantage for LV diastolic function assessment in HD patients. Ten patients (seven with LV hypertrophy) underwent Doppler echocardiography 1 h before, 1 h after, and 1 d after HD. Early (E) and atrial (A) peak transmitral flow velocities, peak PV systolic (s) and diastolic (d) flow velocities, peak e and a mitral annulus velocities in DTI, and early diastolic LV flow propagation velocity (V(p)) were measured. In all patients, the E/A ratio after HD (0.54; 0.37 to 1.02) was lower (P < 0.01) than before HD (0.77; 0.60 to 1.34). E decreased (P < 0.01), whereas A did not. PV s/d after HD (2.15; 1.08 to 3.90) was higher (P < 0.01) than before HD (1.80; 1.25 to 2.68). Tissue e/a after HD (0.40; 0.26 to 0.96) was lower (P < 0.01) than before HD (0.56; 0.40 to 1.05). Tissue e decreased (P < 0.02), whereas a did not. V(p) after HD (30 cm/s; 16 to 47 cm/s) was lower (P < 0.01) than before HD (45 cm/s; 32 to 60 cm/s). Twenty-four hours after the initial measurements values for E/A (0.59; 0.37 to 1.23), PV s/d (1.85; 1.07 to 3.38), e/a (0.41; 0.27 to 1.06), and V(p) (28 cm/s; 23 to 33 cm/s) were similar as those taken 1 h after HD. It is concluded that, even when using the newer Doppler techniques DTI and color M-mode, pseudonormalization, which was due to volume overload before HD, resulted in underestimation of the degree of diastolic dysfunction. Therefore, the advantage of these techniques over conventional parameters for the assessment of LV diastolic function in HD

  13. Nitroglycerin reduces augmentation index and central blood pressure independent of effects on cardiac preload

    Institute of Scientific and Technical Information of China (English)

    Mike; Saddon; Karen; McNeil; Philip; Chowienczyk

    2009-01-01

    Objective To determine whether reduction in central pressure augmentation and central systolic blood pressure by nitroglycerine (NTG) results from effects on pre-load or is due to arterial dilation. Methods We compared effects of NTG with those of lower body negative pressure (LBNP). Hemodynamic measurements were made at rest,during LBNP (10,20 and 30 mmHg,each for 15 min) and after NTG (10,30 and 100 μg/min,each dose for 15 min) in ten healthy volunteers. Cardiac pre-load,stroke volume and cardiac output w...

  14. Sugar, perceived healthfulness, and satiety: When does a sugary preload lead people to eat more?

    Science.gov (United States)

    Mandel, Naomi; Brannon, Daniel

    2017-07-01

    In this research, we examine the interplay between physiological and psychological factors that determine whether the sugar level of a preload increases or decreases consumption on a subsequent snack-eating task. In study 1, participants who drank a high-sugar protein shake (which they believed to be healthy) consumed more subsequent snacks than participants who drank a low-sugar protein shake. Study 2 replicated these findings, but only when the shake was labeled as "healthy." When the shake was labeled as "indulgent," the effect was mitigated. Copyright © 2017 Elsevier Ltd. All rights reserved.

  15. Analysis of time to event outcomes in randomized controlled trials by generalized additive models.

    Directory of Open Access Journals (Sweden)

    Christos Argyropoulos

    Full Text Available Randomized Controlled Trials almost invariably utilize the hazard ratio calculated with a Cox proportional hazard model as a treatment efficacy measure. Despite the widespread adoption of HRs, these provide a limited understanding of the treatment effect and may even provide a biased estimate when the assumption of proportional hazards in the Cox model is not verified by the trial data. Additional treatment effect measures on the survival probability or the time scale may be used to supplement HRs but a framework for the simultaneous generation of these measures is lacking.By splitting follow-up time at the nodes of a Gauss Lobatto numerical quadrature rule, techniques for Poisson Generalized Additive Models (PGAM can be adopted for flexible hazard modeling. Straightforward simulation post-estimation transforms PGAM estimates for the log hazard into estimates of the survival function. These in turn were used to calculate relative and absolute risks or even differences in restricted mean survival time between treatment arms. We illustrate our approach with extensive simulations and in two trials: IPASS (in which the proportionality of hazards was violated and HEMO a long duration study conducted under evolving standards of care on a heterogeneous patient population.PGAM can generate estimates of the survival function and the hazard ratio that are essentially identical to those obtained by Kaplan Meier curve analysis and the Cox model. PGAMs can simultaneously provide multiple measures of treatment efficacy after a single data pass. Furthermore, supported unadjusted (overall treatment effect but also subgroup and adjusted analyses, while incorporating multiple time scales and accounting for non-proportional hazards in survival data.By augmenting the HR conventionally reported, PGAMs have the potential to support the inferential goals of multiple stakeholders involved in the evaluation and appraisal of clinical trial results under proportional and

  16. Conductive and evaporative precooling lowers mean skin temperature and improves time trial performance in the heat.

    Science.gov (United States)

    Faulkner, S H; Hupperets, M; Hodder, S G; Havenith, G

    2015-06-01

    Self-paced endurance performance is compromised by moderate-to-high ambient temperatures that are evident in many competitive settings. It has become common place to implement precooling prior to competition in an attempt to alleviate perceived thermal load and performance decline. The present study aimed to investigate precooling incorporating different cooling avenues via either evaporative cooling alone or in combination with conductive cooling on cycling time trial performance. Ten trained male cyclists completed a time trial on three occasions in hot (35 °C) ambient conditions with the cooling garment prepared by (a) immersion in water (COOL, evaporative); (b) immersion in water and frozen (COLD, evaporative and conductive); or (c) no precooling (CONT). COLD improved time trial performance by 5.8% and 2.6% vs CONT and COOL, respectively (both P COLD vs CONT (P COLD compared with COOL and CONT (both P COLD. The combination of evaporative and conductive cooling (COLD) had the greatest benefit to performance, which is suggested to be driven by reduced skin temperature following cooling. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  17. A method for the production of cryopreserved aliquots of antigen-preloaded, mature dendritic cells ready for clinical use.

    Science.gov (United States)

    Feuerstein, B; Berger, T G; Maczek, C; Röder, C; Schreiner, D; Hirsch, U; Haendle, I; Leisgang, W; Glaser, A; Kuss, O; Diepgen, T L; Schuler, G; Schuler-Thurner, B

    2000-11-01

    Dendritic cells (DC) are increasingly used as a vaccine. Unfortunately, a satisfactory cryopreservation of DC in the absence of FCS is not yet available, so that laborious repeated generation of DC from fresh blood or frozen peripheral blood mononuclear cells for each vaccination has been required to date. We now aimed at developing an effective cryopreservation method, and by testing several variables found that it was crucial to combine the most advantageous maturation stimulus with an improved freezing procedure. We generated monocyte-derived DC from leukapheresis products by using GM-CSF and IL-4 and showed that amongst several known maturation stimuli the cocktail consisting of TNF-alpha+IL-1 beta+IL-6+PGE(2) achieved the highest survival of mature DC. We then systematically explored cryopreservation conditions, and found that freezing matured DC at 1 degrees C/min in pure autologous serum+10% DMSO+5% glucose at a cell density of 10x10(6) DC/ml gave the best results. Using this approach 85-100% of the frozen DC could be recovered in a viable state after thawing (Table 1). The morphology, phenotype, survival as well as functional properties (allogeneic mixed leukocyte reaction, induction of influenza matrix or melan A peptide-specific cytotoxic T cells) of these thawed DC were equivalent to freshly prepared ones. The addition of CD40L or TRANCE/RANKL further improved DC survival. Importantly, we demonstrate that DC can effectively be loaded with antigens (such as Tetanus Toxoid, influenza matrix and melan A peptides) before cryopreservation so that it is now possible to generate antigen-preloaded, frozen DC aliquots that after thawing can be used right away. This is an important advance as both the generation of a standardized DC vaccine under GMP conditions and the carrying out of clinical trials are greatly facilitated.

  18. Should we stop using the determination of central venous pressure as a way to estimate cardiac preload?

    Science.gov (United States)

    Muñoz Nañez, Manuel Felipe

    2012-01-01

    Introduction: The determination of the values of central venous pressure has long been used as a guideline for volumetric therapy in the resuscitation of the critical patient, but the performance of such parameter is currently being questioned as an effective measurement of cardiac preload. This has aroused great interest in the search for more accurate parameters to determine cardiac preload and a patient's blood volume. Goals and Methods: Based on literature currently available, we aim to discuss the performance of central venous pressure as an effective parameter to determine cardiac preload. Results and Conclusion: Estimating variables such as end-diastolic ventricular area and global end-diastolic volume have a better performance than central venous pressure in determining cardiac preload. Despite the best performance of these devices, central venous pressure is still considered in our setting as the most practical and most commonly available way to assess the patient's preload. Only dynamic variables such as pulse pressure change are superior in determining an individual's blood volume. PMID:24893061

  19. Carbohydrate Mouth Rinsing Enhances High Intensity Time Trial Performance Following Prolonged Cycling

    Science.gov (United States)

    Luden, Nicholas D.; Saunders, Michael J.; D’Lugos, Andrew C.; Pataky, Mark W.; Baur, Daniel A.; Vining, Caitlin B.; Schroer, Adam B.

    2016-01-01

    There is good evidence that mouth rinsing with carbohydrate (CHO) solutions can enhance endurance performance (≥30 min). The impact of a CHO mouth rinse on sprint performance has been less consistent, suggesting that CHO may confer benefits in conditions of ‘metabolic strain’. To test this hypothesis, the current study examined the impact of late-exercise mouth rinsing on sprint performance. Secondly, we investigated the effects of a protein mouth rinse (PRO) on performance. Eight trained male cyclists participated in three trials consisting of 120 min of constant-load cycling (55% Wmax) followed by a 30 km computer-simulated time trial, during which only water was provided. Following 15 min of muscle function assessment, 10 min of constant-load cycling (3 min at 35% Wmax, 7 min at 55% Wmax) was performed. This was immediately followed by a 2 km time trial. Subjects rinsed with 25 mL of CHO, PRO, or placebo (PLA) at min 5:00 and 14:30 of the 15 min muscle function phase, and min 8:00 of the 10-min constant-load cycling. Magnitude-based inferential statistics were used to analyze the effects of the mouth rinse on 2-km time trial performance and the following physiological parameters: Maximum Voluntary Contract (MVC), Rating of Perceived Exertion (RPE), Heart Rate (HR), and blood glucose levels. The primary finding was that CHO ‘likely’ enhanced performance vs. PLA (3.8%), whereas differences between PRO and PLA were unclear (0.4%). These data demonstrate that late-race performance is enhanced by a CHO rinse, but not PRO, under challenging metabolic conditions. More data should be acquired before this strategy is recommended for the later stages of cycling competition under more practical conditions, such as when carbohydrates are supplemented throughout the preceding minutes/hours of exercise. PMID:27657117

  20. The Effects of Caffeinated “Energy Shots” on Time Trial Performance

    Directory of Open Access Journals (Sweden)

    Matthew Mark Schubert

    2013-06-01

    Full Text Available An emerging trend in sports nutrition is the consumption of energy drinks and “energy shots”. Energy shots may prove to be a viable pre-competition supplement for runners. Six male runners (mean ± SD age and VO2max: 22.5 ± 1.8 years and 69.1 ± 5.7 mL·kg−1·min−1 completed three trials [placebo (PLA; 0 mg caffeine, Guayakí Yerba Maté Organic Energy Shot™ (YM; 140 mg caffeine, or Red Bull Energy Shot™ (RB; 80 mg caffeine]. Treatments were ingested following a randomized, placebo-controlled crossover design. Participants ran a five kilometer time trial on a treadmill. No differences (p > 0.05 in performance were detected with RB (17.55 ± 1.01 min or YM ingestion (17.86 ± 1.59 min compared to placebo (17.44 ± 1.25 min. Overall, energy shot ingestion did not improve time-trial running performance in trained runners.

  1. Time accuracy of a barcode system for recording resuscitation events: laboratory trials.

    Science.gov (United States)

    Stewart, J A; Short, F A

    1999-11-01

    Barcode systems for recording clinical data from resuscitation attempts offer the prospect of more complete and time-accurate data collection; in addition, collection of data in digital form and the resulting ease of computer processing promises to facilitate data analysis for quality improvement and research. We conducted trials of such a barcode system, recording events during a videotaped, simulated in-hospital resuscitation, with particular attention to time accuracy. Nine subjects watched a videotape of a simulated cardiac resuscitation, recording events first with the barcode system and then with a conventional handwritten form. Recorded times were compared to an accurate record of events (gold standard) from the videotape. Mean absolute errors and standard deviations of errors from the gold standard were significantly smaller with the barcode system (P system is more accurate than conventional handwritten recording in capturing event times from a simulated resuscitation. The system shows promise as a means to improve time accuracy of resuscitation records.

  2. Quantification of the fungal fraction released from various preloaded fibrous filters during a simulated ventilation restart.

    Science.gov (United States)

    Morisseau, K; Joubert, A; Le Coq, L; Andres, Y

    2017-05-01

    This study aimed to demonstrate that particles, especially those associated with fungi, could be released from fibrous filters used in the air-handling unit (AHU) of heating, ventilation and air-conditioning (HVAC) systems during ventilation restarts. Quantification of the water retention capacity and SEM pictures of the filters was used to show the potential for fungal proliferation in unused or preloaded filters. Five fibrous filters with various particle collection efficiencies were studied: classes G4, M5, M6, F7, and combined F7 according to European standard EN779:2012. Filters were clogged with micronized rice particles containing the fungus Penicillium chrysogenum and then incubated for three weeks at 25°C and 90% relative humidity. The results indicated that the five clogged tested filters had various fungal growth capacities depending on their water retention capacity. Preloaded filters were subjected to a simulated ventilation restart in a controlled filtration device to quantify that the fraction of particles released was around 1% for the G4, 0.1% for the M5 and the M6, and 0.001% for the F7 and the combined F7 filter. The results indicate that the likelihood of fungal particle release by low efficiency filters is significantly higher than by high efficiency filters. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  3. Boronophenylalanine uptake in C6 glioma model is dramatically increased by L-DOPA preloading

    Energy Technology Data Exchange (ETDEWEB)

    Capuani, S. [CNR-INFM SOFT, Department of Physics, Sapienza University of Rome, Piazzale Aldo Moro 2, Rome (Italy); Enrico Fermi Center, Compendio Viminale, Rome (Italy)], E-mail: silvia.capuani@roma1.infn.it; Gili, T. [CNR-INFM SOFT, Department of Physics, Sapienza University of Rome, Piazzale Aldo Moro 2, Rome (Italy); Enrico Fermi Center, Compendio Viminale, Rome (Italy); Bozzali, M. [Neuroimaging Laboratory, Santa Lucia Foundation, Via Ardeatina 306, Rome (Italy); Russo, S. [Victor Horsley Department of Neurosurgery, National Hospital for Neurology and Neurosurgery, Queen Square, London (United Kingdom); Porcari, P. [CNR-INFM SOFT, Department of Physics, Sapienza University of Rome, Piazzale Aldo Moro 2, Rome (Italy); Cametti, C. [CNR-INFM SOFT, Department of Physics, Sapienza University of Rome, Piazzale Aldo Moro 2, Rome (Italy); Department of Physics, Sapienza University of Rome, Piazzale Aldo Moro 2, Rome (Italy); Muolo, M. [Department of Biological Science, University ' Rome III' , Viale G. Marconi 446, Rome (Italy); D' Amore, E. [Serv. Qual./Sicurezza Sperim. Anim., Istituto Superiore di Sanita, Rome (Italy); Maraviglia, B. [Enrico Fermi Center, Compendio Viminale, Rome (Italy); Neuroimaging Laboratory, Santa Lucia Foundation, Via Ardeatina 306, Rome (Italy); Lazzarino, G. [Laboratory of Biochemistry, Department of Chemical Sciences, University of Catania, Viale A. Doria 6, Catania (Italy); Pastore, F.S. [Department of Neuroscience, Institute of Neurosurgery, University ' Tor Vergata' , Via Montpellier 1, Rome (Italy)

    2009-07-15

    One of the main limitations for BNCT effectiveness is the insufficient intake of {sup 10}B nuclei within tumour cells. This work was aimed at investigating the use of L-DOPA as enhancer for boronophenylalanine (BPA) uptake in the C6 glioma model. The investigation was first performed in vitro, and then extended in vivo to the animal model. BPA accumulation in C6 glioma cells was assessed, using radiowave dielectric spectroscopy (RDS), with and without L-DOPA preloading. C6 glioma cells were also implanted in the brain of 25 rats, randomly assigned to two experimental branches: (1) intra-carotid BPA infusion; (2) intra-carotid BPA infusion after pre-treatment with L-DOPA, administrated 24 h before BPA infusion. All animals were sacrificed, and assessment of BPA concentrations in tumour tissue, normal brain, and blood samples was performed using high performance liquid chromatography (HPLC). L-DOPA preloading induced a massive increase of BPA concentration either in vitro on C6 glioma cells or in vivo in the animal model tumour. Moreover, no significant difference was found in the normal brain and blood samples between the two animal groups. This study suggests the potential use of L-DOPA as enhancer for BPA accumulation in malignant gliomas eligible for BNCT.

  4. Analyzing noninferiority trials: it is time for advantage deficit assessment – an observational study of published noninferiority trials

    Directory of Open Access Journals (Sweden)

    Gladstone BP

    2015-01-01

    Full Text Available Beryl Primrose Gladstone, Werner Vach Clinical Epidemiology Group, Center for Medical Biometry and Medical Informatics, Medical Center, University of Freiburg, Freiburg, Germany Abstract: The concept of noninferiority (NI trials is based on a belief that the new therapy may potentially offer a benefit for the patient or society in spite of it having a slightly lower efficacy. We introduce advantage deficit assessment (ADA, a simple framework similar to the benefit-risk assessment in superiority trials. ADA balances the advantage gained against the deficit in efficacy on a two-dimensional plane. It requires that NI trials provide quantitative information on both the advantage as well as on efficacy on scales, which can be compared in a meaningful manner. From this perspective, we study the feasibility of ADA among a set of NI trials published in four major medical journals. Among 113 published NI trials, about half assessed and reported at least one claimed advantage. For most other studies, an assessment seems to be feasible if considered in the planning of the study. Many studies claiming noninferiority report a positive gain in advantage. These trials have the potential to demonstrate a significant net benefit in an ADA, substantially changing the final judgment of the study results. ADA seems promising as it overcomes the current limitation of NI trials to demonstrate “only” noninferiority and brings them back to the mainstream of superiority trials by aiming to demonstrate a positive net benefit. ADA seems to be feasible in the majority of NI trials. Keywords: noninferiority, new treatment, potential advantage, advantage deficit assessment, benefit-risk assessment, loss of efficacy

  5. Timing of birth for women with a twin pregnancy at term: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Haslam Ross R

    2010-10-01

    Full Text Available Abstract Background There is a well recognized risk of complications for both women and infants of a twin pregnancy, increasing beyond 37 weeks gestation. Preterm birth prior to 37 weeks gestation is a recognized complication of a twin pregnancy, however, up to 50% of twins will be born after this time. The aims of this randomised trial are to assess whether elective birth at 37 weeks gestation compared with standard care in women with a twin pregnancy affects the risk of perinatal death, and serious infant complications. Methods/Design Design: Multicentred randomised trial. Inclusion Criteria: women with a twin pregnancy at 366 weeks or more without contraindication to continuation of pregnancy. Trial Entry & Randomisation: Following written informed consent, eligible women will be randomised from 36+6 weeks gestation. The randomisation schedule uses balanced variable blocks, with stratification for centre of birth and planned mode of birth. Women will be randomised to either elective birth or standard care. Treatment Schedules: Women allocated to the elective birth group will be planned for elective birth from 37 weeks gestation. Where the plan is for vaginal birth, this will involve induction of labour. Where the plan is for caesarean birth, this will involve elective caesarean section. For women allocated to standard care, birth will be planned for 38 weeks gestation or later. Where the plan is for vaginal birth, this will involve either awaiting the spontaneous onset of labour, or induction of labour if required. Where the plan is for caesarean birth, this will involve elective caesarean section (after 38 and as close to 39 weeks as possible. Primary Study Outcome: A composite of perinatal mortality or serious neonatal morbidity. Sample Size: 460 women with a twin pregnancy to show a reduction in the composite outcome from 16.3% to 6.7% with adjustment for the clustering of twin infants within mothers (p = 0.05, 80% power. Discussion This

  6. Operating Room Time Savings with the Use of Splint Packs: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Tyler Gonzalez

    2016-01-01

    Full Text Available Background: The most expensive variable in the operating room (OR is time. Lean Process Management is being used in the medical field to improve efficiency in the OR. Streamlining individual processes within the OR is crucial to a comprehensive time saving and cost-cutting health care strategy. At our institution, one hour of OR time costs approximately $500, exclusive of supply and personnel costs. Commercially prepared splint packs (SP contain all components necessary for plaster-of-Paris short-leg splint application and have the potential to decrease splint application time and overall costs by making it a more lean process. We conducted a randomized controlled trial comparing OR time savings between SP use and bulk supply (BS splint application. Methods: Fifty consecutive adult operative patients on whom post-operative short-leg splint immobilization was indicated were randomized to either a control group using BS or an experimental group using SP. One orthopaedic surgeon (EMB prepared and applied all of the splints in a standardized fashion. Retrieval time, preparation time, splint application time, and total splinting time for both groups were measured and statistically analyzed. Results: The retrieval time, preparation time and total splinting time were significantly less (p

  7. Metabolic Responses and Pacing Strategies during Successive Sprint Skiing Time Trials

    DEFF Research Database (Denmark)

    Andersson, Erik; Holmberg, Hans-Christer; Ørtenblad, Niels

    2016-01-01

    to estimate the anaerobic energy supply. RESULTS: The individual trial-to-trial variability in STT performance time was 1.3%, where variations in O2 deficit and V˙O2 explained 69% (P 0.05) of the variation in performance. The first and last STTs were equally fast (228 ± 10 s), and ~ 1...... on the first than second course half. In addition, metabolic rates were substantially higher (~_30%) for uphill than for flat skiing, indicating that pacing was regulated to the terrain. CONCLUSIONS: The fastest STTs were characterized primarily by a greater anaerobic energy production, which also explained 69......% of the individual variation in performance. Moreover, the skiers employed positive pacing and a variable exercise intensity according to the course profile, yielding an irregular distribution of anaerobic energy production....

  8. Numerical study on the influences of preload factor on the properties of three-lobe journal bearing

    Institute of Scientific and Technical Information of China (English)

    YAN Qing-hua; YAN Yong-ming; AN Qi

    2008-01-01

    The influences of preload factor on the characteristics of three-lobe journal beating, such as dimen-sionless load capacity, attitude angle, stiffness coefficients and damping coefficients, were studied by using the numerical calculation. And the influences of eccentricity ratio and wide-to-diameter ratio on the characteristics of journal bearing were investigated as well. The results show that with the increasing of preload factor, eccen-tricity ratio and wide-to-diameter ratio, the dimensionless load capacity and damping coefficients increase; meanwhile, the absolute value of stiffness coefficients increases;and with the increasing of preload factor and eccentricity ratio and the decreasing of wide-to-diameter ratio, the attitude angle decreases. The study offers theoretical base for engineering application of three-lobe journal bearing.

  9. The impact of a pre-loaded multi-ingredient performance supplement on muscle soreness and performance following downhill running.

    Science.gov (United States)

    Ormsbee, Michael J; Ward, Emery G; Bach, Christopher W; Arciero, Paul J; McKune, Andrew J; Panton, Lynn B

    2015-01-01

    The effects of multi-ingredient performance supplements (MIPS) on perceived soreness, strength, flexibility and vertical jump performance following eccentric exercise are unknown. The purpose of this study was to determine the impact of MIPS (NO-Shotgun®) pre-loaded 4 weeks prior to a single bout of downhill running (DHR) on muscle soreness and performance. Trained male runners (n = 20) were stratified by VO2max, strength, and lean mass into two groups; MIPS (n = 10) ingested one serving daily of NO-Shotgun® for 28 days and 30 min prior to all post-testing visits, Control (CON; n = 10) consumed an isocaloric maltodextrin placebo in an identical manner as MIPS. Perceived soreness and performance measurements (strength, flexibility, and jump height) were tested on 6 occasions; 28 days prior to DHR, immediately before DHR (PRE), immediately post (POST) DHR, 24, 48, and 72 hr post-DHR. Perceived soreness significantly increased (p < 0.05) post DHR compared to PRE at all time-points, with no difference between groups. Creatine kinase (CK) and lactate dehydrogenase (LDH) increased over time (p < 0.001) with no group x time interactions (p = 0.236 and p = 0.535, respectively). Significant time effects were measured for strength (p = 0.001), flexibility (p = 0.025) and vertical jump (p < 0.001). There were no group x time interactions for any performance measurements. Consumption of MIPS for 4 weeks prior to a single bout of DHR did not affect perceived soreness, muscle damage, strength, flexibility, or jump performance compared to an isocaloric placebo in trained male runners following a single bout of DHR.

  10. Participatory workplace interventions can reduce sedentary time for office workers--a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Sharon Parry

    Full Text Available BACKGROUND: Occupational sedentary behaviour is an important contributor to overall sedentary risk. There is limited evidence for effective workplace interventions to reduce occupational sedentary time and increase light activity during work hours. The purpose of the study was to determine if participatory workplace interventions could reduce total sedentary time, sustained sedentary time (bouts >30 minutes, increase the frequency of breaks in sedentary time and promote light intensity activity and moderate/vigorous activity (MVPA during work hours. METHODS: A randomised controlled trial (ANZCTR NUMBER: ACTN12612000743864 was conducted using clerical, call centre and data processing workers (n = 62, aged 25-59 years in 3 large government organisations in Perth, Australia. Three groups developed interventions with a participatory approach: 'Active office' (n = 19, 'Active Workstation' and promotion of incidental office activity; 'Traditional physical activity' (n = 14, pedometer challenge to increase activity between productive work time and 'Office ergonomics' (n = 29, computer workstation design and breaking up computer tasks. Accelerometer (ActiGraph GT3X, 7 days determined sedentary time, sustained sedentary time, breaks in sedentary time, light intensity activity and MVPA on work days and during work hours were measured before and following a 12 week intervention period. RESULTS: For all participants there was a significant reduction in sedentary time on work days (-1.6%, p = 0.006 and during work hours (-1.7%, p = 0.014 and a significant increase in number of breaks/sedentary hour on work days (0.64, p = 0.005 and during work hours (0.72, p = 0.015; there was a concurrent significant increase in light activity during work hours (1.5%, p = 0.012 and MVPA on work days (0.6%, p = 0.012. CONCLUSIONS: This study explored novel ways to modify work practices to reduce occupational sedentary behaviour

  11. Participatory Workplace Interventions Can Reduce Sedentary Time for Office Workers—A Randomised Controlled Trial

    Science.gov (United States)

    Parry, Sharon; Straker, Leon; Gilson, Nicholas D.; Smith, Anne J.

    2013-01-01

    Background Occupational sedentary behaviour is an important contributor to overall sedentary risk. There is limited evidence for effective workplace interventions to reduce occupational sedentary time and increase light activity during work hours. The purpose of the study was to determine if participatory workplace interventions could reduce total sedentary time, sustained sedentary time (bouts >30 minutes), increase the frequency of breaks in sedentary time and promote light intensity activity and moderate/vigorous activity (MVPA) during work hours. Methods A randomised controlled trial (ANZCTR number: ACTN12612000743864) was conducted using clerical, call centre and data processing workers (n = 62, aged 25–59 years) in 3 large government organisations in Perth, Australia. Three groups developed interventions with a participatory approach: ‘Active office’ (n = 19), ‘Active Workstation’ and promotion of incidental office activity; ‘Traditional physical activity’ (n = 14), pedometer challenge to increase activity between productive work time and ‘Office ergonomics’ (n = 29), computer workstation design and breaking up computer tasks. Accelerometer (ActiGraph GT3X, 7 days) determined sedentary time, sustained sedentary time, breaks in sedentary time, light intensity activity and MVPA on work days and during work hours were measured before and following a 12 week intervention period. Results For all participants there was a significant reduction in sedentary time on work days (−1.6%, p = 0.006) and during work hours (−1.7%, p = 0.014) and a significant increase in number of breaks/sedentary hour on work days (0.64, p = 0.005) and during work hours (0.72, p = 0.015); there was a concurrent significant increase in light activity during work hours (1.5%, p = 0.012) and MVPA on work days (0.6%, p = 0.012). Conclusions This study explored novel ways to modify work practices to reduce occupational sedentary

  12. Global HIV-1 transmitted drug resistance in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial

    DEFF Research Database (Denmark)

    Baxter, J D; Dunn, D; White, E;

    2015-01-01

    of resistance testing in START trial participants. METHODS: In the Strategic Timing of AntiRetroviral Treatment (START) trial, baseline genotypic resistance testing results were collected at study entry and analysed centrally to determine the prevalence of TDR in the study population. Resistance was based...

  13. Analysis of clinical trials with biologics using dose-time-response models.

    Science.gov (United States)

    Lange, Markus R; Schmidli, Heinz

    2015-09-30

    Biologics such as monoclonal antibodies are increasingly and successfully used for the treatment of many chronic diseases. Unlike conventional small drug molecules, which are commonly given as tablets once daily, biologics are typically injected at much longer time intervals, that is, weeks or months. Hence, both the dose and the time interval have to be optimized during the drug development process for biologics. To identify an adequate regimen for the investigated biologic, the dose-time-response relationship must be well characterized, based on clinical trial data. The proposed approach uses semi-mechanistic nonlinear regression models to describe and predict the time-changing response for complex dosing regimens. Both likelihood-based and Bayesian methods for inference and prediction are discussed. The methodology is illustrated with data from a clinical study in an auto-immune disease.

  14. Preload-based starling-like control for rotary blood pumps: numerical comparison with pulsatility control and constant speed operation.

    Directory of Open Access Journals (Sweden)

    Mahdi Mansouri

    Full Text Available In this study, we evaluate a preload-based Starling-like controller for implantable rotary blood pumps (IRBPs using left ventricular end-diastolic pressure (PLVED as the feedback variable. Simulations are conducted using a validated mathematical model. The controller emulates the response of the natural left ventricle (LV to changes in PLVED. We report the performance of the preload-based Starling-like controller in comparison with our recently designed pulsatility controller and constant speed operation. In handling the transition from a baseline state to test states, which include vigorous exercise, blood loss and a major reduction in the LV contractility (LVC, the preload controller outperformed pulsatility control and constant speed operation in all three test scenarios. In exercise, preload-control achieved an increase of 54% in mean pump flow ([Formula: see text] with minimum loading on the LV, while pulsatility control achieved only a 5% increase in flow and a decrease in mean pump speed. In a hemorrhage scenario, the preload control maintained the greatest safety margin against LV suction. PLVED for the preload controller was 4.9 mmHg, compared with 0.4 mmHg for the pulsatility controller and 0.2 mmHg for the constant speed mode. This was associated with an adequate mean arterial pressure (MAP of 84 mmHg. In transition to low LVC, [Formula: see text] for preload control remained constant at 5.22 L/min with a PLVED of 8.0 mmHg. With regards to pulsatility control, [Formula: see text] fell to the nonviable level of 2.4 L/min with an associated PLVED of 16 mmHg and a MAP of 55 mmHg. Consequently, pulsatility control was deemed inferior to constant speed mode with a PLVED of 11 mmHg and a [Formula: see text] of 5.13 L/min in low LVC scenario. We conclude that pulsatility control imposes a danger to the patient in the severely reduced LVC scenario, which can be overcome by using a preload-based Starling-like control approach.

  15. DYNAMIC BUCKLING OF STATICALLY PRELOADED RING-STIFFENED CYLINDRICAL SHELLS UNDER AXIAL FLUID-SOLID IMPACT LOADING

    Institute of Scientific and Technical Information of China (English)

    Jiang Songqing; Li Yongchi; Hu Xiuzhang; Zheng Jijia

    2000-01-01

    The Initial Imperfection Amplified Criterion is applied to investigate the geometric nonlinear dynamic buckling of statically preloaded ring-stiffened cylindrical shells under axial fluid-solid impact. Tak ing account of the effects of large deformation and initial geometric imperfection, the governing equations are obtained by the Galerkin method and solved by the Runge-Kutta method. The effects of static preloading (uniform external radial pressure) on the buckling features and the load-carrying ability of ring-stiffened cy lindrical shells against axial impact are discussed.

  16. Extent of utilization of the Frank-Starling mechanism in conscious dogs. [preload effects on myocardial regulation

    Science.gov (United States)

    Boettcher, D. H.; Vatner, S. F.; Heyndrickx, G. R.; Braunwald, E.

    1978-01-01

    The left ventricular end-diastolic pressure-dimension relationships in conscious dogs were studied; the ventricle was stressed to its limit in terms of myocardial preload in order to assess the extent of use of the Frank-Starling mechanism under these conditions. The preload was increased through volume loading with saline infusions, the provocation of global myocardial ischemia by constriction of the left main coronary artery, and infusion of methoxamine. While left ventricular end-diastolic pressure increased substantially in the reclining conscious animals, the left ventricular end-diastolic diameter did not increase, suggesting a minimum role for the Frank-Starling mechanism in this case.

  17. How many trials are needed to achieve performance stability of the Timed Up & Go test in patients with hip fracture?

    Science.gov (United States)

    Kristensen, Morten T; Ekdahl, Charlotte; Kehlet, Henrik; Bandholm, Thomas

    2010-06-01

    To examine the number of trials needed to achieve performance stability of the Timed Up & Go (TUG) test using a standardized walking aid in patients with hip fracture who are allowed full weight bearing (FWB). Prospective methodologic study. An acute 14-bed orthopedic hip fracture unit. Patients (N=122; 89 women, 33 men) with hip fracture with a median age (25%-75%, quartiles) of 80 (67-85) years performed the TUG on hospital discharge to their own home (n=115) or further inpatient rehabilitation (n=7). Not applicable. After a demonstration by a physical therapist how to perform the TUG with a standardized walking aid (a 4-wheeled rollator), the patients performed 6 timed TUG trials with up to 1-minute seated rest intervals. The participants were given a few minutes to familiarize with the rollator before commencing the timed trials. Repeated-measures analysis of variance (ANOVA) with Bonferroni corrections were used to examine the number of trials needed to ensure statistically stable TUG scores. A total of 106 (87%) patients performed all 6 TUG trials, while 120 patients performed a minimum of 3 timed trials. Repeated-measures ANOVAs of both groups showed that TUG scores improved significantly (Pup to and including the third TUG trial. These results suggest that the original TUG manual, described as 1 practice trial followed by 1 timed trial, needs modification when used in patients with hip fracture who are allowed FWB. The best (fastest) of 3 timed TUG trials performed with a standardized walking aid is recommended. Copyright 2010 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  18. Single-trial time-frequency analysis of electrocortical signals: baseline correction and beyond.

    Science.gov (United States)

    Hu, L; Xiao, P; Zhang, Z G; Mouraux, A; Iannetti, G D

    2014-01-01

    Event-related desynchronization (ERD) and synchronization (ERS) of electrocortical signals (e.g., electroencephalogram [EEG] and magnetoencephalogram) reflect important aspects of sensory, motor, and cognitive cortical processing. The detection of ERD and ERS relies on time-frequency decomposition of single-trial electrocortical signals, to identify significant stimulus-induced changes in power within specific frequency bands. Typically, these changes are quantified by expressing post-stimulus EEG power as a percentage of change relative to pre-stimulus EEG power. However, expressing post-stimulus EEG power relative to pre-stimulus EEG power entails two important and surprisingly neglected issues. First, it can introduce a significant bias in the estimation of ERD/ERS magnitude. Second, it confuses the contribution of pre- and post-stimulus EEG power. Taking the human electrocortical responses elicited by transient nociceptive stimuli as an example, we demonstrate that expressing ERD/ERS as the average percentage of change calculated at single-trial level introduces a positive bias, resulting in an overestimation of ERS and an underestimation of ERD. This bias can be avoided using a single-trial baseline subtraction approach. Furthermore, given that the variability in ERD/ERS is not only dependent on the variability in post-stimulus power but also on the variability in pre-stimulus power, an estimation of the respective contribution of pre- and post-stimulus EEG variability is needed. This can be achieved using a multivariate linear regression (MVLR) model, which could be optimally estimated using partial least square (PLS) regression, to dissect and quantify the relationship between behavioral variables and pre- and post-stimulus EEG activities. In summary, combining single-trial baseline subtraction approach with PLS regression can be used to achieve a correct detection and quantification of ERD/ERS.

  19. Time-dependent changes in excitability after one-trial conditioning of Hermissenda.

    Science.gov (United States)

    Crow, T; Siddiqi, V

    1997-12-01

    The visual system of Hermissenda has been studied extensively as a site of cellular plasticity produced by classical conditioning. A one-trial conditioning procedure consisting of light paired with the application of serotonin (5-HT) to the exposed, but otherwise intact, nervous system produces suppression of phototactic behavior tested 24 h after conditioning. Short- and long-term enhancement (STE and LTE) of excitability in identified type B photoreceptors is a cellular correlate of one-trial conditioning. LTE can be expressed in the absence of STE suggesting that STE and LTE may be parallel processes. To examine the development of enhancement, we studied its time-dependent alterations after one-trial conditioning. Intracellular recordings from identified type B photoreceptors of independent groups collected at different times after conditioning revealed that enhanced excitability follows a biphasic pattern in its development. The analysis of spikes elicited by 2 and 30 s extrinsic current pulses at different levels of depolarization showed that enhancement reached a peak 3 h after conditioning. From its peak, excitability decreased toward baseline control levels 5-6 h after conditioning followed by an increase to a stable plateau at 16 to 24 h postconditioning. Excitability changes measured in cells from unpaired control groups showed maximal changes 1 h posttreatment that rapidly decremented within 2 h. The conditioned stimulus (CS) elicited significantly more spikes 24 h postconditioning for the conditioned group as compared with the unpaired control group. The analysis of the time-dependent development of enhancement may reveal the processes underlying different stages of memory for this associative experience.

  20. The effects of Red Bull energy drink compared with caffeine on cycling time-trial performance.

    Science.gov (United States)

    Quinlivan, Alannah; Irwin, Christopher; Grant, Gary D; Anoopkumar-Dukie, Sheilandra; Skinner, Tina; Leveritt, Michael; Desbrow, Ben

    2015-10-01

    This study investigated the ergogenic effects of a commercial energy drink (Red Bull) or an equivalent dose of anhydrous caffeine in comparison with a noncaffeinated control beverage on cycling performance. Eleven trained male cyclists (31.7 ± 5.9 y 82.3 ± 6.1 kg, VO2max = 60.3 ± 7.8 mL · kg-1 · min-1) participated in a double-blind, placebo-controlled, crossover-design study involving 3 experimental conditions. Participants were randomly administered Red Bull (9.4 mL/kg body mass [BM] containing 3 mg/kg BM caffeine), anhydrous caffeine (3 mg/kg BM given in capsule form), or a placebo 90 min before commencing a time trial equivalent to 1 h cycling at 75% peak power output. Carbohydrate and fluid volumes were matched across all trials. Performance improved by 109 ± 153 s (2.8%, P = .039) after Red Bull compared with placebo and by 120 ± 172 s (3.1%, P = .043) after caffeine compared with placebo. No significant difference (P > .05) in performance time was detected between Red Bull and caffeine treatments. There was no significant difference (P > .05) in mean heart rate or rating of perceived exertion among the 3 treatments. This study demonstrated that a moderate dose of caffeine consumed as either Red Bull or in anhydrous form enhanced cycling time-trial performance. The ergogenic benefits of Red Bull energy drink are therefore most likely due to the effects of caffeine, with the other ingredients not likely to offer additional benefit.

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

    Science.gov (United States)

    Wells, Marc S; Marwood, Simon

    2016-11-01

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

  2. Violation of the right trial within a reasponsable time in an administrative dispute

    Directory of Open Access Journals (Sweden)

    Vukićević-Petković Milica

    2016-01-01

    Full Text Available Basis of the legal regime in administrative disputes in Serbia consists of two constitutional provisions. The first one stating that everyone has the right that an independent and impartial tribunal established by law, fairly and within a reasonabe time publicly discusses and decides about his rights and obligations. The second one stresses that the legality of individual acts deciding on rights, obligations or lawful interest shall be subject to judicial review in administrative action if in a particular case the law doesn't foresee different judicial protection. The right to trial within a resonable time has been introduced into the legal system of the Republic of Serbia by ratifying the European Convention for the protection of Human Right on 26 November 2003. In our constitutional system, the right is directly introduced in the Constitution of the Republic of Serbia from 2006. Beside the guarantees to the right to trial within a reasonable time the Constitution foresees a mechanism for the protection of this right through the particular legal remedy-constitutional complaint.

  3. The effect of music on 10-km cycle time-trial performance.

    Science.gov (United States)

    Hagen, Jana; Foster, Carl; Rodríguez-Marroyo, Jose; de Koning, Jos J; Mikat, Richard P; Hendrix, Charles R; Porcari, John P

    2013-01-01

    Music is widely used as an ergogenic aid in sport, but there is little evidence of its effectiveness during closed-loop athletic events. In order to determine the effectiveness of music as an ergogenic aid, well-trained and task-habituated cyclists performed 10-km cycle time trials either while listening to self-selected motivational music or with auditory input blocked. There were no statistically significant differences in performance time or physiological or psychological markers related to music (time-trial duration17.75 ± 2.10 vs 17.81 ± 2.06 min, mean power output 222 ± 66 vs 220 ± 65 W, peak heart rate184 ± 9 vs 183 ± 8 beats/min, peak blood lactate12.1 ± 2.6 vs 11.9 ± 2.1 mmol/L, and final rating of perceived exertion 8.4 ± 1.5 vs 8.5 ± 1.6). It is concluded that during exercise at competitive intensity, there is no meaningful effect of music on either performance or physiology.

  4. Just-in-time information improved decision-making in primary care: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Jessie McGowan

    Full Text Available BACKGROUND: The "Just-in-time Information" (JIT librarian consultation service was designed to provide rapid information to answer primary care clinical questions during patient hours. This study evaluated whether information provided by librarians to answer clinical questions positively impacted time, decision-making, cost savings and satisfaction. METHODS AND FINDING: A randomized controlled trial (RCT was conducted between October 2005 and April 2006. A total of 1,889 questions were sent to the service by 88 participants. The object of the randomization was a clinical question. Each participant had clinical questions randomly allocated to both intervention (librarian information and control (no librarian information groups. Participants were trained to send clinical questions via a hand-held device. The impact of the information provided by the service (or not provided by the service, additional resources and time required for both groups was assessed using a survey sent 24 hours after a question was submitted. The average time for JIT librarians to respond to all questions was 13.68 minutes/question (95% CI, 13.38 to 13.98. The average time for participants to respond their control questions was 20.29 minutes/question (95% CI, 18.72 to 21.86. Using an impact assessment scale rating cognitive impact, participants rated 62.9% of information provided to intervention group questions as having a highly positive cognitive impact. They rated 14.8% of their own answers to control question as having a highly positive cognitive impact, 44.9% has having a negative cognitive impact, and 24.8% with no cognitive impact at all. In an exit survey measuring satisfaction, 86% (62/72 responses of participants scored the service as having a positive impact on care and 72% (52/72 indicated that they would use the service frequently if it were continued. CONCLUSIONS: In this study, providing timely information to clinical questions had a highly positive impact on

  5. Using Sit-Stand Workstations to Decrease Sedentary Time in Office Workers: A Randomized Crossover Trial

    Directory of Open Access Journals (Sweden)

    Nirjhar Dutta

    2014-06-01

    Full Text Available Objective: This study was conducted to determine whether installation of sit-stand desks (SSDs could lead to decreased sitting time during the workday among sedentary office workers. Methods: A randomized cross-over trial was conducted from January to April, 2012 at a business in Minneapolis. 28 (nine men, 26 full-time sedentary office workers took part in a 4 week intervention period which included the use of SSDs to gradually replace 50% of sitting time with standing during the workday. Physical activity was the primary outcome. Mood, energy level, fatigue, appetite, dietary intake, and productivity were explored as secondary outcomes. Results: The intervention reduced sitting time at work by 21% (95% CI 18%–25% and sedentary time by 4.8 min/work-hr (95% CI 4.1–5.4 min/work-hr. For a 40 h work-week, this translates into replacement of 8 h of sitting time with standing and sedentary time being reduced by 3.2 h. Activity level during non-work hours did not change. The intervention also increased overall sense of well-being, energy, decreased fatigue, had no impact on productivity, and reduced appetite and dietary intake. The workstations were popular with the participants. Conclusion: The SSD intervention was successful in increasing work-time activity level, without changing activity level during non-work hours.

  6. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  7. How many trials are needed to achieve performance stability of the Timed Up & Go test in patients with hip fracture?

    DEFF Research Database (Denmark)

    Kristensen, Morten T; Ekdahl, Charlotte; Kehlet, Henrik;

    2010-01-01

    To examine the number of trials needed to achieve performance stability of the Timed Up & Go (TUG) test using a standardized walking aid in patients with hip fracture who are allowed full weight bearing (FWB)....

  8. How many trials are needed to achieve performance stability of the Timed Up & Go test in patients with hip fracture?

    DEFF Research Database (Denmark)

    Kristensen, Morten T; Ekdahl, Charlotte; Kehlet, Henrik;

    2010-01-01

    To examine the number of trials needed to achieve performance stability of the Timed Up & Go (TUG) test using a standardized walking aid in patients with hip fracture who are allowed full weight bearing (FWB).......To examine the number of trials needed to achieve performance stability of the Timed Up & Go (TUG) test using a standardized walking aid in patients with hip fracture who are allowed full weight bearing (FWB)....

  9. Influence of mass moment of inertia on normal modes of preloaded solar array mast

    Science.gov (United States)

    Armand, Sasan C.; Lin, Paul

    1992-01-01

    Earth-orbiting spacecraft often contain solar arrays or antennas supported by a preloaded mast. Because of weight and cost considerations, the structures supporting the spacecraft appendages are extremely light and flexible; therefore, it is vital to investigate the influence of all physical and structural parameters that may influence the dynamic behavior of the overall structure. The study primarily focuses on the mast for the space station solar arrays, but the formulations and the techniques developed in this study apply to any large and flexible mast in zero gravity. Furthermore, to determine the influence on the circular frequencies, the mass moment of inertia of the mast was incorporated into the governing equation of motion for bending. A finite element technique (MSC/NASTRAN) was used to verify the formulation. Results indicate that when the mast is relatively flexible and long, the mass moment inertia influences the circular frequencies.

  10. Efficacy of Sealing Agents on Preload Maintenance of Screw-Retained Implant-Supported Prostheses.

    Science.gov (United States)

    Seloto, Camila Berbel; Strazzi Sahyon, Henrico Badaoui; Dos Santos, Paulo Henrique; Delben, Juliana Aparecida; Assunção, Wirley Gonçalves

    2017-09-22

    The aim of this study was to evaluate the effect of sealing agents on preload maintenance of screw joints. A total of four groups (n = 10 in each group) of abutment/implant systems, including external hexagon implants and antirotational UCLA abutments with a metallic collar in cobalt-chromium alloy, were assessed. In the control group (CG), no sealing agent was used at the abutment screw/implant interface. In the other groups, three different sealing agents were used at the abutment screw/implant interface: anaerobic sealing agent for medium torque (ASMT), anaerobic sealing agent for high torque (ASHT), and cyanoacrylate-based bonding agent (CYAB). All abutments were attached to the implants at 32 ± 1 N.cm. After 48 ± 2 hours of initial tightening, loosing torque (detorque) was measured using a digital torque wrench. Data were analyzed using Shapiro-Wilk, Wilcoxon, and Kruskal-Wallis tests, at 5% level of significance. In the CG and ASMT groups, detorque was lower than the insertion torque (24.6 ± 1.5 N.cm and 24.3 ± 1.1 N.cm, respectively). In the ASHT and CYAB groups, mean detorque increased in comparison to the insertion torque (51.0 ± 7.4 N.cm and 47.7 ± 15.1 N.cm, respectively). The ASHT was more efficient than the other sealing agents, increasing the remaining preload (detorque value) 58.88%. Although the cyanoacrylate-based bonding agent also generated high detorque values, the high standard deviation suggested its lower reliability.

  11. The influence of isometric preload on power expressed during bench press in strength-trained men.

    Science.gov (United States)

    Bartolomei, Sandro; Fukuda, David H; Hoffman, Jay R; Stout, Jeffrey R; Merni, Franco

    2017-03-01

    The purpose of this study was to compare the power expressed during the bench press exercise in resistance-trained men following different pre-activation conditions. Twenty-two trained men (age 24.1 ± 1.7 years, height 178.6 ± 6.1 cm, body mass 81.1 ± 10.6 kg) completed a maximal effort bench press (1-RM) test (100.0 kg ± 8.1 kg). In a subsequent assessment, each participant performed concentric bench press movements with loads of 20%, 30%, 40% and 50% of their 1-RM preceded by either a concentric contraction (CC), a low isometric preload (LIP; 70% 1-RM) or a high isometric preload (HIP; 100% 1-RM) conditions. All movements were performed in a Smith machine with a settable quick-release device. Participants performed all three conditions in randomized fashion. Results indicated that power outputs during the bench press exercise following HIP were significantly (p < 0.05) greater than CC at 20% 1-RM (+9%), 30% 1-RM (+16%) and 40% 1-RM (+14%), and LIP at 20% 1-RM (+4%), 30% 1-RM (+20%) and 40% 1-RM (+15%). No differences were found between conditions at 50% 1-RM. Area under the force-power curve with HIP was greater (p < 0.05) than with CC and LIP. In conclusion, results of this study indicate that the use of a HIP (100% 1-RM) in trained participants results in significantly greater power output during the concentric phase of a multi-joint exercise when compared to standard concentric movement.

  12. Preload-based Starling-like control of rotary blood pumps: An in-vitro evaluation

    Science.gov (United States)

    Gregory, Shaun D.; Salamonsen, Robert F.; Lovell, Nigel H.; Stevens, Michael C.; Pauls, Jo P.; Akmeliawati, Rini; Lim, Einly

    2017-01-01

    Due to a shortage of donor hearts, rotary left ventricular assist devices (LVADs) are used to provide mechanical circulatory support. To address the preload insensitivity of the constant speed controller (CSC) used in conventional LVADs, we developed a preload-based Starling-like controller (SLC). The SLC emulates the Starling law of the heart to maintain mean pump flow (QP¯) with respect to mean left ventricular end diastolic pressure (PLVEDm) as the feedback signal. The SLC and CSC were compared using a mock circulation loop to assess their capacity to increase cardiac output during mild exercise while avoiding ventricular suction (marked by a negative PLVEDm) and maintaining circulatory stability during blood loss and severe reductions in left ventricular contractility (LVC). The root mean squared hemodynamic deviation (RMSHD) metric was used to assess the clinical acceptability of each controller based on pre-defined hemodynamic limits. We also compared the in-silico results from our previously published paper with our in-vitro outcomes. In the exercise simulation, the SLC increased QP¯ by 37%, compared to only 17% with the CSC. During blood loss, the SLC maintained a better safety margin against left ventricular suction with PLVEDm of 2.7 mmHg compared to -0.1 mmHg for CSC. A transition to reduced LVC resulted in decreased mean arterial pressure (MAP) and QP¯ with CSC, whilst the SLC maintained MAP and QP¯. The results were associated with a much lower RMSHD value with SLC (70.3%) compared to CSC (225.5%), demonstrating improved capacity of the SLC to compensate for the varying cardiac demand during profound circulatory changes. In-vitro and in-silico results demonstrated similar trends to the simulated changes in patient state however the magnitude of hemodynamic changes were different, thus justifying the progression to in-vitro evaluation. PMID:28212401

  13. Preload recruitable stroke work in the presence of intact cardiovascular reflexes in rats fed a diet high in unsaturated fats.

    Science.gov (United States)

    Trifunovic, B; Woodiwiss, A J; Norton, G R

    1995-01-15

    A decreased inotropic effect of myocardial beta receptor agonists in animals receiving diets high in unsaturated fats (UNSAT) has been demonstrated. The effect of an UNSAT diet on myocardial systolic performance under different loading conditions, in the presence of intact cardiovascular reflexes, has not been examined. We investigated the effect of an UNSAT diet on preload recruitable stroke work (SW) in the anaesthetised, open chest, ventilated rat. A control (CONTROL, 11% by energy), a high saturated fat (SAT, 37% by energy) and a high UNSAT (37% by energy) diet were fed to three groups of rats. At three months, systolic myocardial performance (stroke work: SW) at increasing left ventricular end diastolic pressures (LVEDP) was measured within a physiological preload range. There were no significant differences in either the slope or the intercept of the LVEDP/SW relation were found between the three diet groups. Systemic vascular resistance and heart rate decreased to the same extent in the three diet groups over the range of preloads examined. This occurred as a consequence of intact baroreceptor reflexes. Hence dietary modulation of unsaturated fats does not influence myocardial contraction over a wide range of physiological preloads in the presence of intact baroreceptor reflexes.

  14. Echocardiographic Measures of Diastolic Function Are Preload Dependent during Triggered Positive Pressure Ventilation: A Controlled Crossover Study in Healthy Subjects

    Directory of Open Access Journals (Sweden)

    Peter Juhl-Olsen

    2012-01-01

    Full Text Available Background. The use of echocardiography in intensive care settings impacts decision making. A prerequisite for the use of echocardiography is relative resistance to changes in volume status and levels of positive pressure ventilation (PPV. Studies on indices of diastolic function report conflicting results with regard to dependence on volume status. Evidence is scarce on PPV. Methods. Ten healthy subjects were exposed to 6 levels of positive end-expiratory pressure (PEEP and pressure support (PS following a baseline reading. All ventilator settings were performed at three positions: horizontal, reverse-Trendelenburg, and Trendelenburg. Echocardiography was performed throughout. Results. During spontaneous breathing, early diastolic transmitral velocity ( changed with positioning (, whereas early diastolic velocity of the mitral annulus ( was independent (. With PPV, and proved preload dependent (. Increases in PEEP, PS, or a combination influenced and in reverse-Trendelenburg- and horizontal positions, but not in the Trendelenburg position. Discussion. The change towards preload dependency of with PPV suggests that PPV increases myocardial preload sensitivity. The susceptibility of and to preload changes during PPV discourages their use in settings of volume shifts or during changes in ventilator settings. Conclusion. Positioning and PPV affect and .

  15. Trunk response to sudden forward perturbations - effects of preload and sudden load magnitudes, posture and abdominal antagonistic activation.

    Science.gov (United States)

    Shahvarpour, Ali; Shirazi-Adl, Aboulfazl; Mecheri, Hakim; Larivière, Christian

    2014-06-01

    Unexpected loading of the spine is a risk factor for low back pain. The trunk neuromuscular and kinematics responses are likely influenced by the perturbation itself as well as initial trunk conditions. The effect of four parameters (preload, sudden load, initial trunk flexed posture, initial abdominal antagonistic activity) on trunk kinematics and back muscles reflex response were evaluated. Twelve asymptomatic subjects participated in sudden forward perturbation tests under six distinct conditions. Preload did not change the reflexive response of back muscles and the trunk displacement; while peak trunk velocity and acceleration as well as the relative load peak decreased. Sudden load increased reflex response of muscles, trunk kinematics and loading variables. When the trunk was initially flexed, back muscles latency was delayed, trunk velocity and acceleration increased; however, reflex amplitude and relative trunk displacement remained unchanged. Abdominal antagonistic preactivation increased reflexive response of muscles but kinematics variables were not affected. Preload, initial flexed posture and abdominal muscles preactivation increased back muscles preactivity. Both velocity and acceleration peaks of the trunk movement decreased with preload despite greater total load. In contrast, they increased in the initial flexed posture and to some extent when abdominal muscles were preactivated demonstrating the distinct effects of pre-perturbation variables on trunk kinematics and risk of injury. Copyright © 2014 Elsevier Ltd. All rights reserved.

  16. Participatory workplace interventions can reduce sedentary time for office workers--a randomised controlled trial.

    Science.gov (United States)

    Parry, Sharon; Straker, Leon; Gilson, Nicholas D; Smith, Anne J

    2013-01-01

    Occupational sedentary behaviour is an important contributor to overall sedentary risk. There is limited evidence for effective workplace interventions to reduce occupational sedentary time and increase light activity during work hours. The purpose of the study was to determine if participatory workplace interventions could reduce total sedentary time, sustained sedentary time (bouts >30 minutes), increase the frequency of breaks in sedentary time and promote light intensity activity and moderate/vigorous activity (MVPA) during work hours. A randomised controlled trial (ANZCTR NUMBER: ACTN12612000743864) was conducted using clerical, call centre and data processing workers (n = 62, aged 25-59 years) in 3 large government organisations in Perth, Australia. Three groups developed interventions with a participatory approach: 'Active office' (n = 19), 'Active Workstation' and promotion of incidental office activity; 'Traditional physical activity' (n = 14), pedometer challenge to increase activity between productive work time and 'Office ergonomics' (n = 29), computer workstation design and breaking up computer tasks. Accelerometer (ActiGraph GT3X, 7 days) determined sedentary time, sustained sedentary time, breaks in sedentary time, light intensity activity and MVPA on work days and during work hours were measured before and following a 12 week intervention period. For all participants there was a significant reduction in sedentary time on work days (-1.6%, p = 0.006) and during work hours (-1.7%, p = 0.014) and a significant increase in number of breaks/sedentary hour on work days (0.64, p = 0.005) and during work hours (0.72, p = 0.015); there was a concurrent significant increase in light activity during work hours (1.5%, p = 0.012) and MVPA on work days (0.6%, p = 0.012). This study explored novel ways to modify work practices to reduce occupational sedentary behaviour. Participatory workplace interventions can reduce

  17. Comparison of design strategies for a three-arm clinical trial with time-to-event endpoint: Power, time-to-analysis, and operational aspects.

    Science.gov (United States)

    Asikanius, Elina; Rufibach, Kaspar; Bahlo, Jasmin; Bieska, Gabriele; Burger, Hans Ulrich

    2016-11-01

    To optimize resources, randomized clinical trials with multiple arms can be an attractive option to simultaneously test various treatment regimens in pharmaceutical drug development. The motivation for this work was the successful conduct and positive final outcome of a three-arm randomized clinical trial primarily assessing whether obinutuzumab plus chlorambucil in patients with chronic lympocytic lymphoma and coexisting conditions is superior to chlorambucil alone based on a time-to-event endpoint. The inference strategy of this trial was based on a closed testing procedure. We compare this strategy to three potential alternatives to run a three-arm clinical trial with a time-to-event endpoint. The primary goal is to quantify the differences between these strategies in terms of the time it takes until the first analysis and thus potential approval of a new drug, number of required events, and power. Operational aspects of implementing the various strategies are discussed. In conclusion, using a closed testing procedure results in the shortest time to the first analysis with a minimal loss in power. Therefore, closed testing procedures should be part of the statistician's standard clinical trials toolbox when planning multiarm clinical trials. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  18. On the estimation of intracluster correlation for time-to-event outcomes in cluster randomized trials.

    Science.gov (United States)

    Kalia, Sumeet; Klar, Neil; Donner, Allan

    2016-12-30

    Cluster randomized trials (CRTs) involve the random assignment of intact social units rather than independent subjects to intervention groups. Time-to-event outcomes often are endpoints in CRTs. Analyses of such data need to account for the correlation among cluster members. The intracluster correlation coefficient (ICC) is used to assess the similarity among binary and continuous outcomes that belong to the same cluster. However, estimating the ICC in CRTs with time-to-event outcomes is a challenge because of the presence of censored observations. The literature suggests that the ICC may be estimated using either censoring indicators or observed event times. A simulation study explores the effect of administrative censoring on estimating the ICC. Results show that ICC estimators derived from censoring indicators or observed event times are negatively biased. Analytic work further supports these results. Observed event times are preferred to estimate the ICC under minimum frequency of administrative censoring. To our knowledge, the existing literature provides no practical guidance on the estimation of ICC when substantial amount of administrative censoring is present. The results from this study corroborate the need for further methodological research on estimating the ICC for correlated time-to-event outcomes. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  19. Single and combined effects of beetroot juice and caffeine supplementation on cycling time trial performance.

    Science.gov (United States)

    Lane, Stephen C; Hawley, John A; Desbrow, Ben; Jones, Andrew M; Blackwell, James R; Ross, Megan L; Zemski, Adam J; Burke, Louise M

    2014-09-01

    Both caffeine and beetroot juice have ergogenic effects on endurance cycling performance. We investigated whether there is an additive effect of these supplements on the performance of a cycling time trial (TT) simulating the 2012 London Olympic Games course. Twelve male and 12 female competitive cyclists each completed 4 experimental trials in a double-blind Latin square design. Trials were undertaken with a caffeinated gum (CAFF) (3 mg·kg(-1) body mass (BM), 40 min prior to the TT), concentrated beetroot juice supplementation (BJ) (8.4 mmol of nitrate (NO3(-)), 2 h prior to the TT), caffeine plus beetroot juice (CAFF+BJ), or a control (CONT). Subjects completed the TT (females: 29.35 km; males: 43.83 km) on a laboratory cycle ergometer under conditions of best practice nutrition: following a carbohydrate-rich pre-event meal, with the ingestion of a carbohydrate-electrolyte drink and regular oral carbohydrate contact during the TT. Compared with CONT, power output was significantly enhanced after CAFF+BJ and CAFF (3.0% and 3.9%, respectively, p supplementation when used alone (-0.4%, p = 0.6 compared with CONT) or when combined with caffeine (-0.9%, p = 0.4 compared with CAFF). We conclude that caffeine (3 mg·kg(-1) BM) administered in the form of a caffeinated gum increased cycling TT performance lasting ∼50-60 min by ∼3%-4% in both males and females. Beetroot juice supplementation was not ergogenic under the conditions of this study.

  20. The effect of dehydration on muscle metabolism and time trial performance during prolonged cycling in males.

    Science.gov (United States)

    Logan-Sprenger, Heather M; Heigenhauser, George J F; Jones, Graham L; Spriet, Lawrence L

    2015-08-01

    This study combined overnight fluid restriction with lack of fluid intake during prolonged cycling to determine the effects of dehydration on substrate oxidation, skeletal muscle metabolism, heat shock protein 72 (Hsp72) response, and time trial (TT) performance. Nine males cycled at ~65% VO2peak for 90 min followed by a TT (6 kJ/kg BM) either with fluid (HYD) or without fluid (DEH). Blood samples were taken every 20 min and muscle biopsies were taken at 0, 45, and 90 min of exercise and after the TT. DEH subjects started the trial with a -0.6% BM from overnight fluid restriction and were dehydrated by 1.4% after 45 min, 2.3% after 90 min of exercise, and 3.1% BM after the TT. There were no significant differences in oxygen uptake, carbon dioxide production, or total sweat loss between the trials. However, physiological parameters (heart rate [HR], rate of perceived exertion, core temperature [Tc], plasma osmolality [Posm], plasma volume [Pvol] loss, and Hsp72), and carbohydrate (CHO) oxidation and muscle glycogen use were greater during 90 min of moderate cycling when subjects progressed from 0.6% to 2.3% dehydration. TT performance was 13% slower when subjects began 2.3% and ended 3.1% dehydrated. Throughout the TT, Tc, Posm, blood and muscle lactate [La], and serum Hsp72 were higher, even while working at a lower power output (PO). The accelerated muscle glycogen use during 90 min of moderate intensity exercise with DEH did not affect subsequent TT performance, rather augmented Tc, RPE and the additional physiological factors were more important in slowing performance when dehydrated.

  1. Modeling Population Spike Trains with Specified Time-Varying Spike Rates, Trial-to-Trial Variability, and Pairwise Signal and Noise Correlations.

    Science.gov (United States)

    Lyamzin, Dmitry R; Macke, Jakob H; Lesica, Nicholas A

    2010-01-01

    As multi-electrode and imaging technology begin to provide us with simultaneous recordings of large neuronal populations, new methods for modeling such data must also be developed. Here, we present a model for the type of data commonly recorded in early sensory pathways: responses to repeated trials of a sensory stimulus in which each neuron has it own time-varying spike rate (as described by its PSTH) and the dependencies between cells are characterized by both signal and noise correlations. This model is an extension of previous attempts to model population spike trains designed to control only the total correlation between cells. In our model, the response of each cell is represented as a binary vector given by the dichotomized sum of a deterministic "signal" that is repeated on each trial and a Gaussian random "noise" that is different on each trial. This model allows the simulation of population spike trains with PSTHs, trial-to-trial variability, and pairwise correlations that match those measured experimentally. Furthermore, the model also allows the noise correlations in the spike trains to be manipulated independently of the signal correlations and single-cell properties. To demonstrate the utility of the model, we use it to simulate and manipulate experimental responses from the mammalian auditory and visual systems. We also present a general form of the model in which both the signal and noise are Gaussian random processes, allowing the mean spike rate, trial-to-trial variability, and pairwise signal and noise correlations to be specified independently. Together, these methods for modeling spike trains comprise a potentially powerful set of tools for both theorists and experimentalists studying population responses in sensory systems.

  2. Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bouwense Stefan A

    2012-11-01

    Full Text Available Abstract Background After an initial attack of biliary pancreatitis, cholecystectomy minimizes the risk of recurrent biliary pancreatitis and other gallstone-related complications. Guidelines advocate performing cholecystectomy within 2 to 4 weeks after discharge for mild biliary pancreatitis. During this waiting period, the patient is at risk of recurrent biliary events. In current clinical practice, surgeons usually postpone cholecystectomy for 6 weeks due to a perceived risk of a more difficult dissection in the early days following pancreatitis and for logistical reasons. We hypothesize that early laparoscopic cholecystectomy minimizes the risk of recurrent biliary pancreatitis or other complications of gallstone disease in patients with mild biliary pancreatitis without increasing the difficulty of dissection and the surgical complication rate compared with interval laparoscopic cholecystectomy. Methods/Design PONCHO is a randomized controlled, parallel-group, assessor-blinded, superiority multicenter trial. Patients are randomly allocated to undergo early laparoscopic cholecystectomy, within 72 hours after randomization, or interval laparoscopic cholecystectomy, 25 to 30 days after randomization. During a 30-month period, 266 patients will be enrolled from 18 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite endpoint of mortality and acute re-admissions for biliary events (that is, recurrent biliary pancreatitis, acute cholecystitis, symptomatic/obstructive choledocholithiasis requiring endoscopic retrograde cholangiopancreaticography including cholangitis (with/without endoscopic sphincterotomy, and uncomplicated biliary colics occurring within 6 months following randomization. Secondary endpoints include the individual endpoints of the composite endpoint, surgical and other complications, technical difficulty of cholecystectomy and costs. Discussion The PONCHO trial is designed to show that early

  3. Augmented case-only designs for randomized clinical trials with failure time endpoints.

    Science.gov (United States)

    Dai, James Y; Zhang, Xinyi Cindy; Wang, Ching-Yun; Kooperberg, Charles

    2016-03-01

    Under suitable assumptions and by exploiting the independence between inherited genetic susceptibility and treatment assignment, the case-only design yields efficient estimates for subgroup treatment effects and gene-treatment interaction in a Cox model. However it cannot provide estimates of the genetic main effect and baseline hazards, that are necessary to compute the absolute disease risk. For two-arm, placebo-controlled trials with rare failure time endpoints, we consider augmenting the case-only design with random samples of controls from both arms, as in the classical case-cohort sampling scheme, or with a random sample of controls from the active treatment arm only. The latter design is motivated by vaccine trials for cost-effective use of resources and specimens so that host genetics and vaccine-induced immune responses can be studied simultaneously in a bigger set of participants. We show that these designs can identify all parameters in a Cox model and that the efficient case-only estimator can be incorporated in a two-step plug-in procedure. Results in simulations and a data example suggest that incorporating case-only estimators in the classical case-cohort design improves the precision of all estimated parameters; sampling controls only in the active treatment arm attains a similar level of efficiency.

  4. Exercise-induced dehydration does not alter time trial or neuromuscular performance.

    Science.gov (United States)

    Stewart, C J; Whyte, D G; Cannon, J; Wickham, J; Marino, F E

    2014-08-01

    This study examined the effect of exercise-induced dehydration by ~4% body mass loss on 5-km cycling time trial (TT) performance and neuromuscular drive, independent of hyperthermia. 7 active males were dehydrated on 2 occasions, separated by 7 d. Participants remained dehydrated (DEH, -3.8±0.5%) or were rehydrated (REH, 0.2±0.6%) over 2 h before completing the TT at 18-25 °C, 20-30% relative humidity. Neuromuscular function was determined before dehydration and immediately prior the TT. The TT started at the same core temperature (DEH, 37.3±0.3°C; REH, 37.0±0.2 °C (P>0.05). Neither TT performance (DEH, 7.31±1.5 min; REH, 7.10±1.3 min (P>0.05)) or % voluntary activation were affected by dehydration (DEH, 88.7±6.4%; REH, 90.6±6.1% (P>0.05)). Quadriceps peak torque was significantly elevated in both trials prior to the TT (Pperformance and neuromuscular function are not reduced by dehydration, independent of hyperthermia.

  5. Time to benefit for colorectal cancer screening: survival meta-analysis of flexible sigmoidoscopy trials.

    Science.gov (United States)

    Tang, Victoria; Boscardin, W John; Stijacic-Cenzer, Irena; Lee, Sei J

    2015-04-16

    To determine the time to benefit of using flexible sigmoidoscopy for colorectal cancer screening. Survival meta-analysis. A Cochrane Collaboration systematic review published in 2013, Medline, and Cochrane Library databases. Randomized controlled trials comparing screening flexible sigmoidoscopy with no screening. Trials with fewer than 100 flexible sigmoidoscopy screenings were excluded. Four studies were eligible (total n = 459,814). They were similar for patients' age (50-74 years), length of follow-up (11.2-11.9 years), and relative risk for colorectal cancer related mortality (0.69-0.78 with flexible sigmoidoscopy screening). For every 1000 people screened at five and 10 years, 0.3 and 1.2 colorectal cancer related deaths, respectively, were prevented. It took 4.3 years (95% confidence interval 2.8 to 5.8) to observe an absolute risk reduction of 0.0002 (one colorectal cancer related death prevented for every 5000 flexible sigmoidoscopy screenings). It took 9.4 years (7.6 to 11.3) to observe an absolute risk reduction of 0.001 (one colorectal cancer related death prevented for every 1000 flexible sigmoidoscopy screenings). Our findings suggest that screening flexible sigmoidoscopy is most appropriate for older adults with a life expectancy greater than approximately 10 years. © Tang et al 2015.

  6. Familiarization Protocol Influences Reproducibility of 20-km Cycling Time-Trial Performance in Novice Participants

    Directory of Open Access Journals (Sweden)

    Andrew W. Hibbert

    2017-07-01

    Full Text Available Introduction: Exercise performance is reproducible in experienced athletes; however, less trained participants exhibit greater variability in performance and pacing. To reduce variability, it is common practice to complete a familiarization prior to experimental testing. However, there are no clear guidelines for familiarizing novice participants to a cycling time-trial (TT, and research findings from novice populations may still be influenced by learning effects. Accordingly, the aims of this study were to establish the variability between TTs after administering differing familiarization protocols (duration or type and to establish the number of familiarization trials required to limit variability over multiple trials.Methods: Thirty recreationally active participants, with no prior experience of a TT, performed a 20-km cycling TT on five separate occasions, after completing either a full (FF, 20-km TT, n = 10, a half (HF, 10-km TT, n = 10 or an equipment familiarization (EF, 5-min cycling, n = 10.Results: Variability of TT duration across five TTs was the lowest after completing FF (P = 0.69, ηp2 = 0.05 compared to HF (P = 0.08, ηp2 = 0.26 and EF (P = 0.07, ηp2 = 0.21. In the FF group after TT2, the effect size for changes in TT duration was small (d < 0.49. There were large differences between later TTs in HF (d = 1.02, TT3-TT4 and EF (d = 1.12, TT4-TT5. The variability in mean power output profiles between trials was lowest within FF, with a similar pacing profile reproduced between TT3-TT5.Discussion: Familiarization of the exercise protocol influenced reproducibility of pacing and performance over multiple, maximal TTs, with best results obtained after a full experience of the exercise compared to HF and EF. The difference of TT1 to later TTs indicates that one familiarization is not adequate in reducing the variability of performance for novice participants. After the FF and an additional TT, performance changes between TTs were small

  7. Time, PASI and DLQI of psoriasis patients who "drop out" of clinical trials on etanercept due to "lack of efficacy" - a pooled analysis from ten clinical trials.

    Science.gov (United States)

    Nast, A; Dilleen, M; Liyanage, W; Aikman, L; Szczypa, P; Dressler, C

    2017-08-03

    Patient-reported outcomes in psoriasis studies are assessed at specific study time points. If a treatment has not become effective by a certain time point, it may increase the likelihood of patients being dissatisfied and leaving a clinical study. Generate evidence concerning the number of patients dropping out of etanercept trials over time including PASI and DLQI data. Data from psoriasis patients in ten trials with etanercept were pooled. Analyses were performed for a) patients who dropped out due to 'lack of efficacy' b) patients who continued the trial. Psoriasis Area Severity Index (PASI) and Dermatology Life Quality Index (DLQI) data were summarized for different time points. Distribution of dropouts over time, PASI and DLQI and the proportion of patients dropping out with given treatment responses, were calculated. Of 6119 patients 128 dropped out due to 'lack of efficacy'(or synonym). The highest increase of patients dropping out happened between Day 75 and 85 (46% to 73%). The lowest PASI of patients dropping out was 6.3 within 120 days. Dropouts who achieved ≥ PASI 75 were rare. A critical time when many patients might have lost their willingness to wait for their treatment with etanercept to show a better effect appeared to be at around Day 80. Most of the patients dropping out showed little improvement, stable disease or worsening of their psoriasis. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  8. RARtool: A MATLAB Software Package for Designing Response-Adaptive Randomized Clinical Trials with Time-to-Event Outcomes.

    Science.gov (United States)

    Ryeznik, Yevgen; Sverdlov, Oleksandr; Wong, Weng Kee

    2015-08-01

    Response-adaptive randomization designs are becoming increasingly popular in clinical trial practice. In this paper, we present RARtool, a user interface software developed in MATLAB for designing response-adaptive randomized comparative clinical trials with censored time-to-event outcomes. The RARtool software can compute different types of optimal treatment allocation designs, and it can simulate response-adaptive randomization procedures targeting selected optimal allocations. Through simulations, an investigator can assess design characteristics under a variety of experimental scenarios and select the best procedure for practical implementation. We illustrate the utility of our RARtool software by redesigning a survival trial from the literature.

  9. Relationship between velocity reached at VO2(max) and time-trial performances in elite Australian Rules footballers.

    Science.gov (United States)

    Lorenzen, Christian; Williams, Morgan D; Turk, Paul S; Meehan, Daniel L; Kolsky, Daniel J Cicioni

    2009-09-01

    Running velocity reached at maximal oxygen uptake (vVO2(max)) can be a useful measure to prescribe training intensity for aerobic conditioning. Obtaining it in the laboratory is often not practical, and average velocities from time trials are an attractive alternative. To date, the efficacies of such practices for team sport players are unknown. This study aimed to assess the relationship between vVO2(max) obtained in the laboratory against two time-trial estimates (1500 m and 3200 m). During the early preseason, elite Australian Rules football players (n = 23, 22.7 +/- 3.4 y, 187.7 +/- 8.2 cm, 75.5 +/- 9.2 kg) participated in a laboratory test on a motorized treadmill and two outdoor time trials. Based on average velocity the 1500-m time-trial performance (5.01 +/- 0.23 m x s(-1)) overestimated (0.36 m x s(-1), d = 1.75), whereas the 3200-m time trial (4.47 +/- 0.23 m x s(-1)) underestimated (0.17 m x s(-1), d = 0.83) the laboratory vVO2(max) (4.64 +/- 0.18 m x s(-1)). Despite these differences, both 1500-m and 3200-m time-trial performances correlated with the laboratory measure (r = -0.791; r = -0.793 respectively). Both subsequent linear regressions were of good fit and predicted the laboratory measure within +/- 0.12 m x s(-1). Estimates of vVO2(max) should not be used interchangeably, nor should they replace the laboratory measure. When laboratory testing is not accessible for team sports players, prescription of training intensity may be more accurately estimated from linear regression based on either 1500-m or 3200-m time-trial performance than from the corresponding average velocity.

  10. Smartphone mobile application delivering personalized, real-time sun protection advice: a randomized clinical trial.

    Science.gov (United States)

    Buller, David B; Berwick, Marianne; Lantz, Kathy; Buller, Mary Klein; Shane, James; Kane, Ilima; Liu, Xia

    2015-05-01

    Mobile smartphones are rapidly emerging as an effective means of communicating with many Americans. Using mobile applications (apps), they can access remote databases, track time and location, and integrate user input to provide tailored health information. A smartphone mobile app providing personalized, real-time sun protection advice was evaluated in a randomized clinical trial. The trial was conducted in 2012 and had a randomized pretest-posttest controlled design with a 10-week follow-up. Data were collected from a nationwide population-based survey panel. A sample of 604 non-Hispanic and Hispanic adults from the Knowledge Panel 18 years or older who owned an Android smartphone were enrolled. The mobile app provided advice on sun protection (ie, protection practices and risk of sunburn) and alerts (to apply or reapply sunscreen and get out of the sun), hourly UV Index, and vitamin D production based on the forecast UV Index, the phone's time and location, and user input. Percentage of days using sun protection and time spent outdoors (days and minutes) in the midday sun and number of sunburns in the past 3 months were collected. Individuals in the treatment group reported more shade use (mean days staying in the shade, 41.0% vs 33.7%; P = .03) but less sunscreen use (mean days, 28.6% vs 34.5%; P = .048) than controls. There was no significant difference in number of sunburns in the past 3 months (mean, 0.60 in the treatment group vs 0.62 for controls; P = .87). Those who used the mobile app reported spending less time in the sun (mean days keeping time in the sun to a minimum, 60.4% for app users vs 49.3% for nonusers; P = .04) and using all protection behaviors combined more (mean days, 39.4% vs 33.8%; P = .04). The mobile app improved some sun protection. Use of the mobile app was lower than expected but associated with increased sun protection. Providing personalized advice when and where people are in the sun may help reduce sun exposure.

  11. A Randomized Controlled Trial to Determine the Appropriate Time to Initiate Peritoneal Dialysis after Insertion of Catheter (Timely PD Study).

    Science.gov (United States)

    Ranganathan, Dwarakanathan; John, George T; Yeoh, Edward; Williams, Nicola; O'Loughlin, Barry; Han, Thin; Jeyaseelan, Lakshmanan; Ramanathan, Kavitha; Healy, Helen

    2017-01-01

    The optimal time for the commencement of peritoneal dialysis (PD) after PD catheter insertion is unclear. If dialysis is started too soon after insertion, dialysate leaks and infection could occur. However, by starting PD earlier, morbidity and costs can be reduced through lesser hemodialysis requirements. This is the first randomized controlled trial to determine the safest and shortest interval to commence PD after catheter insertion. All consecutive patients undergoing PD catheter insertion at the Royal Brisbane and Women's Hospital and Rockhampton Hospital from 1 March 2008 to 31 May 2013 who met the inclusion and exclusion criteria were invited to participate in the trial. Participants were randomized to 1 of 3 groups. Group 1 (G1) commenced PD at 1 week, group 2 (G2) at 2 weeks and group 3 (G3) at 4 weeks after PD catheter insertion. These groups were stratified by hospital and the presence of diabetes. Primary outcomes were the incidence of peritoneal fluid leaks or PD-related infection during the 4 weeks after commencement of PD. In total 122 participants were recruited, 39, 42, and 41 randomized to G1, G2, and G3, respectively. The primary outcome catheter leak was significantly higher in G1 (28.2%) compared with G3 (2.4%, p = 0.001) but not compared with G2 (9.5%, p = 0.044), based on intention to treat analysis. These differences were even more marked when analyzed with per protocol method: G1 had a significantly higher percentage (32.4 %) compared with G3 (3.3%, p = 0.003) but not compared with G2 (10.5%, p = 0.040). Event percentages of leak were statistically higher in G1 and occurred significantly earlier compared with other groups (p = 0.002). Amongst diabetics, technique failure was significantly higher (28.6%) in G3 compared with 0% in G1 and 7.1% in G2 (p = 0.036) and earlier in G3 at 163.2 days vs 176.8 and 175.8 (p = 0.037) for G1 and G2, respectively. Leaks were higher in participants commencing PD at 1 week after catheter insertion compared

  12. Aerodynamics of a cycling team in a time trial: does the cyclist at the front benefit?

    Energy Technology Data Exchange (ETDEWEB)

    Iniguez-de-la Torre, A; Iniguez, J [Departamento de Fisica Aplicada, Universidad de Salamanca, E37071 (Spain)], E-mail: nacho@usal.es

    2009-11-15

    When seasonal journeys take place in nature, birds and fishes migrate in groups. This provides them not only with security but also a considerable saving of energy. The power they need to travel requires overcoming aerodynamic or hydrodynamic drag forces, which can be substantially reduced when the group travels in an optimal arrangement. Also in this area, humans imitate nature, which is especially evident in the practice of outdoor sports and motor competitions. Cycle races, in which speeds of up to 15 m s{sup -1} are frequent, offer great opportunities to appreciate the advantage of travelling in a group. Here we present a brief analysis of the aerodynamics of a cycling team in a time-trial challenge, showing how each rider is favoured according to his position in the group. We conclude that the artificial tail wind created by the team also benefits the cyclist at the front by about 5%.

  13. Cervical dilation at the time of cesarean section for dystocia - effect on subsequent trial of labor

    DEFF Research Database (Denmark)

    Abildgaard, Helle; Diness, Marie; Nickelsen, Carsten

    2012-01-01

    Objective. To investigate the effect of cervical dilation at the time of cesarean section due to dystocia and success in a subsequent pregnancy of attempted vaginal delivery. Design. Retrospective study. Setting. University hospital in Copenhagen capital area. Population. All women with a prior...... cesarean section due to dystocia who had undergone a subsequent pregnancy with a singleton delivery during 2006-2010. Methods. Medical records were reviewed for prior vaginal birth, cervical dilation reached before cesarean section and induction of labor, gestational age, use of oxytocin, epidural...... anesthesia and mode of birth was collected. Results. A total of 889 women were included; 373 had had a trial of labor. The success rate for vaginal birth among women with prior cesarean section for dystocia at 4-8 cm dilation was 39%, but 59% for women in whom prior cesarean section had been done at a fully...

  14. A Randomized Trial of Time-Limited Antiretroviral Therapy in Acute/Early HIV Infection.

    Directory of Open Access Journals (Sweden)

    Joseph B Margolick

    Full Text Available It has been proposed that initiation of antiretroviral treatment (ART very soon after establishment of HIV infection may be beneficial by improving host control of HIV replication and delaying disease progression.People with documented HIV infection of less than 12 months' duration in Baltimore MD and seven Canadian sites were randomized to either a observation and deferred ART, or b immediate treatment with ART for 12 months. All subjects not receiving ART were followed quarterly and permanent ART was initiated according to contemporaneous treatment guidelines. The endpoint of the trial was total ART-free time from study entry until initiation of permanent ART.One hundred thirteen people were randomized, 56 to the observation arm and 57 to the immediate treatment arm. Twenty-three had acute (<2 months infection and 90 early (2-12 months infection. Of those randomized to the immediate treatment arm, 37 completed 12 months of ART according to protocol, 9 declined to stop ART after 12 months, and 11 were nonadherent to the protocol or lost to follow-up. Comparing those in the observation arm to either those who completed 12 months of ART or all 56 who were randomized to immediate ART, there was no significant difference between the arms in treatment-free interval after study entry, which was about 18 months in both arms.This study did not find a benefit from administration of a brief, time-limited (12-month course of ART in acute or early HIV infection.ClinicalTrials.gov NCT00106171.

  15. Time-dependent approach for single trial classification of covert visuospatial attention

    Science.gov (United States)

    Tonin, L.; Leeb, R.; Millán, J. del R.

    2012-08-01

    Recently, several studies have started to explore covert visuospatial attention as a control signal for brain-computer interfaces (BCIs). Covert visuospatial attention represents the ability to change the focus of attention from one point in the space without overt eye movements. Nevertheless, the full potential and possible applications of this paradigm remain relatively unexplored. Voluntary covert visuospatial attention might allow a more natural and intuitive interaction with real environments as neither stimulation nor gazing is required. In order to identify brain correlates of covert visuospatial attention, classical approaches usually rely on the whole α-band over long time intervals. In this work, we propose a more detailed analysis in the frequency and time domains to enhance classification performance. In particular, we investigate the contribution of α sub-bands and the role of time intervals in carrying information about visual attention. Previous neurophysiological studies have already highlighted the role of temporal dynamics in attention mechanisms. However, these important aspects are not yet exploited in BCI. In this work, we studied different methods that explicitly cope with the natural brain dynamics during visuospatial attention tasks in order to enhance BCI robustness and classification performances. Results with ten healthy subjects demonstrate that our approach identifies spectro-temporal patterns that outperform the state-of-the-art classification method. On average, our time-dependent classification reaches 0.74 ± 0.03 of the area under the ROC (receiver operating characteristic) curve (AUC) value with an increase of 12.3% with respect to standard methods (0.65 ± 0.4). In addition, the proposed approach allows faster classification (<1 instead of 3 s), without compromising performances. Finally, our analysis highlights the fact that discriminant patterns are not stable for the whole trial period but are changing over short time

  16. Effects of a Protein Preload on Gastric Emptying, Glycemia, and Gut Hormones After a Carbohydrate Meal in Diet-Controlled Type 2 Diabetes

    OpenAIRE

    Ma, Jing; Stevens, Julie E.; Cukier, Kimberly; Maddox, Anne F.; Wishart, Judith M.; Jones, Karen L.; Clifton, Peter M.; Horowitz, Michael; Rayner, Christopher K.

    2009-01-01

    OBJECTIVE We evaluated whether a whey preload could slow gastric emptying, stimulate incretin hormones, and attenuate postprandial glycemia in type 2 diabetes. RESEARCH DESIGN AND METHODS Eight type 2 diabetic patients ingested 350 ml beef soup 30 min before a potato meal; 55 g whey was added to either the soup (whey preload) or potato (whey in meal) or no whey was given. RESULTS Gastric emptying was slowest after the whey preload (P < 0.0005). The incremental area under the blood glucose cur...

  17. Fluid loading and norepinephrine infusion mask the left ventricular preload decrease induced by pleural effusion.

    Science.gov (United States)

    Wemmelund, Kristian Borup; Ringgård, Viktor Kromann; Vistisen, Simon Tilma; Hyldebrandt, Janus Adler; Sloth, Erik; Juhl-Olsen, Peter

    2017-09-11

    Pleural effusion (PLE) may lead to low blood pressure and reduced cardiac output. Low blood pressure and reduced cardiac output are often treated with fluid loading and vasopressors. This study aimed to determine the impact of fluid loading and norepinephrine infusion on physiologic determinants of cardiac function obtained by ultrasonography during PLE. In this randomised, blinded, controlled laboratory study, 30 piglets (21.9 ± 1.3 kg) had bilateral PLE (75 mL/kg) induced. Subsequently, the piglets were randomised to intervention as follows: fluid loading (80 mL/kg/h for 1.5 h, n = 12), norepinephrine infusion (0.01, 0.03, 0.05, 0.1, 0.2 and 0.3 μg/kg/min (15 min each, n = 12)) or control (n = 6). Main outcome was left ventricular preload measured as left ventricular end-diastolic area. Secondary endpoints included contractility and afterload as well as global measures of circulation. All endpoints were assessed with echocardiography and invasive pressure-flow measurements. PLE decreased left ventricular end-diastolic area, mean arterial pressure and cardiac output (p values  0.05) to baseline. Left ventricular contractility increased with norepinephrine infusion (p = 0.002), but was not affected by fluid loading (p = 0.903). Afterload increased in both active groups (p values > 0.001). Overall, inferior vena cava distensibility remained unchanged during intervention (p values ≥ 0.085). Evacuation of PLE caused numerical increases in left ventricular end-diastolic area, but only significantly so in controls (p = 0.006). PLE significantly reduced left ventricular preload. Both fluid and norepinephrine treatment reverted this effect and normalised global haemodynamic parameters. Inferior vena cava distensibility remained unchanged. The haemodynamic significance of PLE may be underestimated during fluid or norepinephrine administration, potentially masking the presence of PLE.

  18. Hubble trial: time to stick to basics for treatment of haemorrhoids?

    Science.gov (United States)

    Brown, S R

    2017-01-01

    The results of the Hubble trial, a randomised controlled trial comparing haemorrhoidal artery ligation with rubber band ligation for early-grade prolapsing haemorrhoids, are discussed. The difficulties in defining treatment success are debated along with the trial design highlighting the pitfalls of previous research. A finding that haemorrhoidal artery ligation is not necessarily superior to cheap alternatives has implications for current practice and future commissioning of surgeons.

  19. The effect of exercise training with an additional inspiratory load on inspiratory muscle fatigue and time-trial performance.

    Science.gov (United States)

    McEntire, Serina J; Smith, Joshua R; Ferguson, Christine S; Brown, Kelly R; Kurti, Stephanie P; Harms, Craig A

    2016-08-01

    The purpose was to determine the effect of moderate-intensity exercise training (ET) on inspiratory muscle fatigue (IMF) and if an additional inspiratory load during ET (ET+IL) would further improve inspiratory muscle strength, IMF, and time-trial performance. 15 subjects were randomly divided to ET (n=8) and ET+IL groups (n=7). All subjects completed six weeks of exercise training three days/week at ∼70%V̇O2peak for 30min. The ET+IL group breathed through an inspiratory muscle trainer (15% PImax) during exercise. 5-mile, and 30-min time-trials were performed pre-training, weeks three and six. Inspiratory muscle strength increased (p0.05) extent. ET and ET+IL groups improved (ptraining following the 5-mile time-trial. In conclusion, these data suggest ET leads to less IMF, ET+IL improves inspiratory muscle strength and IMF, but not different than ET alone.

  20. Trial of real-time locating and messaging system with Bluetooth low energy.

    Science.gov (United States)

    Arisaka, Naoya; Mamorita, Noritaka; Isonaka, Risa; Kawakami, Tadashi; Takeuchi, Akihiro

    2016-09-14

    Hospital real-time location systems (RTLS) are increasing efficiency and reducing operational costs, but room access tags are necessary. We developed three iPhone 5 applications for an RTLS and communications using Bluetooth low energy (BLE). The applications were: Peripheral device tags, Central beacons, and a Monitor. A Peripheral communicated with a Central using BLE. The Central communicated with a Monitor using sockets on TCP/IP (Transmission Control Protocol/Internet Protocol) via a WLAN (wireless local area network). To determine a BLE threshold level for the received signal strength indicator (RSSI), relationships between signal strength and distance were measured in our laboratory and on the terrace. The BLE RSSI threshold was set at -70 dB, about 10 m. While an individual with a Peripheral moved around in a concrete building, the Peripheral was captured in a few 10-sec units at about 10 m from a Central. The Central and Monitor showed and saved the approach events, location, and Peripheral's nickname sequentially in real time. Remote Centrals also interactively communicate with Peripherals by intermediating through Monitors that found the nickname in the event database. Trial applications using BLE on iPhones worked well for patient tracking, and messaging in indoor environments.

  1. Aerodynamics of cyclist posture, bicycle and helmet characteristics in time trial stage.

    Science.gov (United States)

    Chabroux, Vincent; Barelle, Caroline; Favier, Daniel

    2012-07-01

    The present work is focused on the aerodynamic study of different parameters, including both the posture of a cyclist's upper limbs and the saddle position, in time trial (TT) stages. The aerodynamic influence of a TT helmet large visor is also quantified as a function of the helmet inclination. Experiments conducted in a wind tunnel on nine professional cyclists provided drag force and frontal area measurements to determine the drag force coefficient. Data statistical analysis clearly shows that the hands positioning on shifters and the elbows joined together are significantly reducing the cyclist drag force. Concerning the saddle position, the drag force is shown to be significantly increased (about 3%) when the saddle is raised. The usual helmet inclination appears to be the inclination value minimizing the drag force. Moreover, the addition of a large visor on the helmet is shown to provide a drag coefficient reduction as a function of the helmet inclination. Present results indicate that variations in the TT cyclist posture, the saddle position and the helmet visor can produce a significant gain in time (up to 2.2%) during stages.

  2. The effect of β-alanine supplementation on cycling time trials of different length.

    Science.gov (United States)

    Bellinger, Phillip M; Minahan, Clare L

    2016-10-01

    The varying results reported in response to β-alanine supplementation may be related to the duration and nature of the exercise protocol employed. We investigated the effects of β-alanine supplementation on a wide range of cycling performance tests in order to produce a clear concise set of criteria for its efficacy. Fourteen trained cyclists (Age = 24.8 ± 6.7 years; VO2max = 65.4 ± 10.2 mL·kg·min(-1)) participated in this placebo-controlled, double-blind study. Prior to supplementation, subjects completed two (familiarization and baseline) supramaximal cycling bouts until exhaustion (120% pre-supplementation VO2max) and two 1-, 4- and 10-km cycling time trial (TT). Subjects then supplemented orally for 4 weeks with 6.4 g/d placebo or β-alanine and repeated the battery of performance tests. Blood lactate was measured pre-exercise, post-exercise and 5  min post-exercise. β-alanine supplementation elicited significant increases in time to exhaustion (TTE) (17.6 ± 11.5 s; p = 0.013, effect compared with placebo) and was likely to be beneficial to 4-km TT performance time (-7.8 ± 8.1 s; 94% likelihood), despite not being statistically different (p = 0.060). Performance times in the 1- and 10-km TT were not affected by treatment. For the highly trained cyclists in the current study, β-alanine supplementation significantly extended supramaximal cycling TTE and may have provided a worthwhile improvement to 4-km TT performance. However, 1- and 10-km cycling TT performance appears to be unaffected by β-alanine supplementation.

  3. Nitroglycerin reduces augmentation index and central blood pressure independent of effects on cardiac preload

    Institute of Scientific and Technical Information of China (English)

    Bao-min Liu; Xiao-lin Niu; Ben-yu Jiang; Mike Saddon; Karen McNeil; Philip Chowienczyk

    2009-01-01

    Objective To determine whether reduction In central pressure augmentation and central systolic blood pressure by nitroglycerine (NTG) results from effects on pre-lead or is due to arterial dilation. Methods We compared effects of NTG with these of lower body negative pressure (LBNP). Hemodyunmic measurements were made at rest, during LBNP (10, 20 and 30 mmHg, each for 15 min) and after NTG (10, 30 and 100μg/min, each dose for 15 min) in ten healthy volunteers. Cardiac pre-lead, stroke volume and cardiac output were assessed by echacardiography. Central pressure an mnentation and central systolic pressure were obtained by radial tonometry using a transfer function. Results LBNP (20 mmHg) and NTG (30μg/min) reduced pre-lead (as measured by the peak velocity of the S wave in the superior vena eava) to a similar degree [by (26. 8 ± 3.8) % and (23.9 ± 3. 4) %, respectively]. Compared to LBNP, NTG reduced systemic vascular resistance [by (32. 9 ± 7.5) %, p< 0. 01], decreased peripheral and central pressure augmentation [by (20. 8 ± 3. 4)% units and (12. 9±2. 9)% units, respectively, each P< 0. 01]. Conclusion These results suggest that a reduction in pre-load does not explain reduction in pressure augmentation and central systolic blood pressure by NTG and that these effects are mediated through arterial dilation.

  4. Finite Element Analysis on the Pre-load Structures of the Central Solenoid for the HT-7U Device

    Institute of Scientific and Technical Information of China (English)

    2001-01-01

    The central solenoid is an important part of the HT-7U device. In this paper, the computational analysis of the stress and the displacement on the pre-load structures of the central solenoid have been made by the finite element analysis system COSMOS/M2.0 under room and/or operating temperature. According to the analytical results, the clip aprons and compression plates are all satisfied with safety design criteria.

  5. Linearity of the Frank-Starling relationship in the intact heart: the concept of preload recruitable stroke work.

    Science.gov (United States)

    Glower, D D; Spratt, J A; Snow, N D; Kabas, J S; Davis, J W; Olsen, C O; Tyson, G S; Sabiston, D C; Rankin, J S

    1985-05-01

    The Frank-Starling relationship generally has been examined with filling pressure as the index of preload, resulting in a curvilinear function that plateaus at higher filling pressures. To investigate this relationship further in the intact heart, 32 dogs were chronically instrumented with left ventricular and pleural micromanometers and with regional (10 dogs) or global (22 dogs) ultrasonic dimension transducers. Seven days after implantation, left ventricular pressure and regional or global dimensions were recorded in the conscious state. After autonomic blockade, preload was varied by vena caval occlusion. Myocardial function was assessed by calculating regional or global stroke work, and preload was measured as end-diastolic segment length or chamber volume. The relationship between stroke work and either end-diastolic segment length or chamber volume (termed the preload recruitable stroke work relationship) was highly linear in every study (mean r = .97) and could be quantified by a slope (MW) and x-intercept (LW). Previous nonlinear relationships between stroke work and filling pressure seemed to reflect the exponential diastolic pressure-volume curve. Over the physiologic range of systolic arterial pressures produced by infusion of nitroprusside or phenylephrine, no significant change was observed in MW or LW in the normal dog. Calcium infusion increased both regional and global MW by 71 +/- 19% and 65 +/- 9%, respectively (p less than .02), with no significant change in LW. To normalize for ventricular geometry and heart rate, stroke work was computed from circumferential stress-strain data and converted to myocardial power output, which was then plotted against end-diastolic circumferential strain. This relationship also was highly linear, and the slope, Mmp (mW/cm3 of myocardium), is proposed as a potential measure of intrinsic myocardial performance independent of loading, geometry, and heart rate.

  6. Time-Based Physical Activity Interventions for Weight Loss: A Randomized Trial

    Science.gov (United States)

    Jakicic, John M.; Rickman, Amy D.; Lang, Wei; Davis, Kelliann K.; Gibbs, Bethany Barone; Neiberg, Rebecca; Marcus, Marsha D.

    2014-01-01

    Purpose To examine whether enhancing standard behavior weight loss interventions (SBWP) with additional strategies at the initiation of the intervention (ADOPT) or providing the additional strategies at predetermined times over the intervention period (MAINTAIN) enhances 18 month weight loss. Methods This was a clinical trial with participants (n=195; age= 43.2±8.6 yrs; BMI= 33.0±3.4 kg/m2) randomized to SBWP, ADOPT, or MAINTAIN. All were prescribed an energy restricted diet and physical activity, with group intervention sessions delivered over 18 months. ADOPT received additional phone contact (months 1–3), supervised exercise (months 1–6), and behavior campaigns (months 4–9). MAINTAIN received additional phone contact (months 4–6), supervised exercise (months 7–12), and behavior campaigns (months 13–18). Results There was a significant Group X Time interaction for weight loss (p=0.0032). SBWP lost 9.3±0.9, 7.8±1.1, and 5.9±1.2 kg at 6, 12, and 18 months, respectively. ADOPT lost 8.9±0.9, 7.6±1.2, and 5.8±1.2 kg, and MAINTAIN lost 9.7±0.9, 11.0±1.2, and 9.0±1.2 kg at 6, 12, and 18 months, respectively. The Group X Time interaction for SBWP vs. MAINTAIN (p=0.0033) and ADOPT vs. MAINTAIN (p=0.0075) was significant. There was a significant Group X Time interaction for change in fitness (p=0.0060). The Group X Time interaction for MAINTAIN vs. ADOPT (p=0.0018) was significant with a trend for MAINTAIN vs. SBWP (p=0.0525). Conclusions MAINTAIN improved 18-month weight loss compared to SBWP and ADOPT, with statistical trends that MAINTAIN resulted in greater improvements in fitness. These results suggest that time-based strategies emphasizing physical activity conferred greater benefits when delivered later and over the full course of intervention. This provides valuable information for the implementation of time-based strategies to improve long-term weight loss and fitness in overweight and obese adults. PMID:25160843

  7. Strategies of dietary carbohydrate manipulation and their effects on performance in cycling time trials.

    Science.gov (United States)

    Correia-Oliveira, Carlos Rafaell; Bertuzzi, Romulo; Dal'Molin Kiss, Maria Augusta Peduti; Lima-Silva, Adriano Eduardo

    2013-08-01

    The relationship between carbohydrate (CHO) availability and exercise performance has been thoroughly discussed. CHO improves performance in both prolonged, low-intensity and short, high-intensity exercises. Most studies have focused on the effects of CHO supplementation on the performance of constant-load, time-to-exhaustion exercises. Nevertheless, in the last 20 years, there has been a consistent increase in research on the effects of different forms of CHO supplementation (e.g., diet manipulation, CHO supplementation before or during exercise) on performance during closed-loop exercises, such as cycling time trials (TTs). A TT is a highly reproducible exercise and reflects a more realistic scenario of competition compared with the time-to-exhaustion test. CHO manipulation has been performed in various time periods, such as days before, minutes before, during a TT or in a matched manner (e.g. before and during a TT). The purpose of this review is to address the possible effects of these different forms of CHO manipulation on the performance during a cycling TT. Previous data suggest that when a high-CHO diet (~70% of CHO) is consumed before a TT (24-72 h before), the mean power output increases and reduces the TT time. When participants are supplemented with CHO (from 45 to 400 g) prior to a TT (from 2 min to 6 h before the TT), mean power output and time seem to improve due to an increase in CHO oxidation. Similarly, this performance also seems to increase when participants ingest CHO during a TT because such consumption maintains plasma glucose levels. A CHO mouth rinse also improves performance by activating several brain areas related to reward and motor control through CHO receptors in the oral cavity. However, some studies reported controversial results concerning the benefits of CHO on TT performance. Methodological issues such as time of supplementation, quantity, concentration and type of CHO ingested, as well as the TT duration and intensity, should be

  8. A dynamic model of the windlass mechanism of the foot: evidence for early stance phase preloading of the plantar aponeurosis.

    Science.gov (United States)

    Caravaggi, Paolo; Pataky, Todd; Goulermas, John Y; Savage, Russel; Crompton, Robin

    2009-08-01

    In the present study we have estimated the temporal elongation of the plantar aponeurosis (PA) during normal walking using a subject-specific multi-segment rigid-body model of the foot. As previous studies have suggested that muscular forces at the ankle can pre-load the PA prior to heel-strike, the main purpose of the current study was to test, through modelling, whether there is any tension present in the PA during early stance phase. Reflective markers were attached to bony landmarks to track the kinematics of the calcaneus, metatarsus and toes during barefoot walking. Ultrasonography measurements were performed on three subjects to determine both the location of the origin of the PA on the plantar aspect of the calcaneus, and the radii of the metatarsal heads. Starting with the foot in a neutral, unloaded position, inverse kinematics allowed calculation of the tension in the five slips of the PA during the whole duration of the stance phase. The results show that the PA experienced tension significantly above rest during early stance phase in all subjects (P<0.01), thus providing support for the PA-preloading hypothesis. The amount of preloading and the maximum elongation of the slips of the PA decreased from medial to lateral. The mean maximum tension exerted by the PA was 1.5 BW (body weight) over the three subjects.

  9. Rotordynamic Evaluation of Full Scale Rotor on Tilting Pad Bearings with 0.1 and 0.3 Preload

    Directory of Open Access Journals (Sweden)

    Weimin Wang

    2014-01-01

    Full Text Available A system identification method for rotating machinery stability evaluation is investigated based on sine sweep excitation testing with electromagnetic actuator. The traditional MIMO FRF is transformed into dFRF from real number field to complex field with a transformation matrix, eliminating the influence of forward and backward modal overlap and providing higher accuracy to identify rotor’s first forward modal parameters using the rational polynomial method. The modal parameters are acquired for stability estimation. Furthermore, two sets of bearing with preloads of 0.1 and 0.3 under both load-on-pad (LOP and load-between-pad (LBP conditions are investigated. The effects of oil inlet pressure (1.0 bar–1.75 bar and temperature (43°C–51°C on the stability of rotor are investigated in detail. Results indicate that the stability of rotor will be improved by increasing the oil inlet temperature and pressure. It is found that the rotor is more stable on bearing with 0.1 preload than that of 0.3 preload. Load-on-pad provides more damping to rotor than load-between-pad. The method and outcomes of this paper can provide both theory basis and technology foundation for improving the rotor stability of centrifugal compressors.

  10. An analytical solution for two-dimensional vacuum preloading combined with electro-osmosis consolidation using EKG electrodes.

    Science.gov (United States)

    Shen, Yang; Qiu, Chenchen; Li, Yande; Shi, Wen; Rui, Xiaoxi

    2017-01-01

    China is a country with vast territory, but economic development and population growth have reduced the usable land resources in recent years. Therefore, reclamation by pumping and filling is carried out in eastern coastal regions of China in order to meet the needs of urbanization. However, large areas of reclaimed land need rapid drainage consolidation treatment. Based on past researches on how to improve the treatment efficiency of soft clay using vacuum preloading combined with electro-osmosis, a two-dimensional drainage plane model was proposed according to the Terzaghi and Esrig consolidation theory. However, the analytical solution using two-dimensional plane model was never involved. Current analytical solutions can't have a thorough theoretical analysis of practical engineering and give relevant guidance. Considering the smearing effect and the rectangle arrangement pattern, an analytical solution is derived to describe the behavior of pore-water and the consolidation process by using EKG (electro-kinetic geo synthetics) materials. The functions of EKG materials include drainage, electric conduction and corrosion resistance. Comparison with test results is carried out to verify the analytical solution. It is found that the measured value is larger than the applied vacuum degree because of the stacking effect of the vacuum preloading and electro-osmosis. The trends of the mean measured value and the mean analytical value processes are comparable. Therefore, the consolidation model can accurately assess the change in pore-water pressure and the consolidation process during vacuum preloading combined with electro-osmosis.

  11. Exploring molecular sieve capabilities of activated carbon fibers to reduce the impact of NOM preloading on trichloroethylene adsorption.

    Science.gov (United States)

    Karanfil, Tanju; Dastgheib, Seyed A; Mauldin, Dina

    2006-02-15

    Adsorption of trichloroethylene (TCE) by two activated carbon fibers (ACFs) and two granular activated carbons (GACs) preloaded with hydrophobic and transphilic fractions of natural organic matter (NOM) was examined. ACF10, the most microporous activated carbon used in this study, had over 90% of its pore volume in pores smaller than 10 A. It also had the highest volume in pores 5-8 A, which is the optimum pore size region for TCE adsorption, among the four activated carbons. Adsorption of NOM fractions by ACF10 was, in general, negligible. Therefore, ACF10, functioning as a molecular sieve during preloading, exhibited the least NOM uptake for each fraction, and subsequently the highest TCE adsorption. The other three sorbents had wider pore size distributions, including high volumes in pores larger than 10 A, where NOM molecules can adsorb. As a result, they showed a higher degree of uptake for all NOM fractions, and subsequently lower adsorption capacities for TCE, as compared to ACF10. The results obtained in this study showed that understanding the interplay between the optimum pore size region for the adsorption of target synthetic organic contaminant (SOC) and the pore size region for the adsorption of NOM molecules is important for controlling NOM-SOC competitions. Experiments with different NOM fractions indicated that the degree of NOM loading is important in terms of preloading effects; however the waythatthe carbon pores are filled and loaded by different NOM fractions can be different and may create an additional negative impact on TCE adsorption.

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

    Science.gov (United States)

    Safarkhani, Maryam; Moerbeek, Mirjam

    2013-01-01

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

  13. Assurance calculations for planning clinical trials with time-to-event outcomes.

    Science.gov (United States)

    Ren, Shijie; Oakley, Jeremy E

    2014-01-15

    We consider the use of the assurance method in clinical trial planning. In the assurance method, which is an alternative to a power calculation, we calculate the probability of a clinical trial resulting in a successful outcome, via eliciting a prior probability distribution about the relevant treatment effect. This is typically a hybrid Bayesian-frequentist procedure, in that it is usually assumed that the trial data will be analysed using a frequentist hypothesis test, so that the prior distribution is only used to calculate the probability of observing the desired outcome in the frequentist test. We argue that assessing the probability of a successful clinical trial is a useful part of the trial planning process. We develop assurance methods to accommodate survival outcome measures, assuming both parametric and nonparametric models. We also develop prior elicitation procedures for each survival model so that the assurance calculations can be performed more easily and reliably. We have made free software available for implementing our methods.

  14. Changes in clinical trials methodology over time: a systematic review of six decades of research in psychopharmacology.

    Directory of Open Access Journals (Sweden)

    André R Brunoni

    Full Text Available BACKGROUND: There have been many changes in clinical trials methodology since the introduction of lithium and the beginning of the modern era of psychopharmacology in 1949. The nature and importance of these changes have not been fully addressed to date. As methodological flaws in trials can lead to false-negative or false-positive results, the objective of our study was to evaluate the impact of methodological changes in psychopharmacology clinical research over the past 60 years. METHODOLOGY/PRINCIPAL FINDINGS: We performed a systematic review from 1949 to 2009 on MEDLINE and Web of Science electronic databases, and a hand search of high impact journals on studies of seven major drugs (chlorpromazine, clozapine, risperidone, lithium, fluoxetine and lamotrigine. All controlled studies published 100 months after the first trial were included. Ninety-one studies met our inclusion criteria. We analyzed the major changes in abstract reporting, study design, participants' assessment and enrollment, methodology and statistical analysis. Our results showed that the methodology of psychiatric clinical trials changed substantially, with quality gains in abstract reporting, results reporting, and statistical methodology. Recent trials use more informed consent, periods of washout, intention-to-treat approach and parametric tests. Placebo use remains high and unchanged over time. CONCLUSIONS/SIGNIFICANCE: Clinical trial quality of psychopharmacological studies has changed significantly in most of the aspects we analyzed. There was significant improvement in quality reporting and internal validity. These changes have increased study efficiency; however, there is room for improvement in some aspects such as rating scales, diagnostic criteria and better trial reporting. Therefore, despite the advancements observed, there are still several areas that can be improved in psychopharmacology clinical trials.

  15. Rejection Positivity Predicts Trial-to-Trial Reaction Times in an Auditory Selective Attention Task: A Computational Analysis of Inhibitory Control

    Directory of Open Access Journals (Sweden)

    Sufen eChen

    2014-08-01

    Full Text Available A series of computer simulations using variants of a formal model of attention (Melara & Algom, 2003 probed the role of rejection positivity (RP, a slow-wave electroencephalographic (EEG component, in the inhibitory control of distraction. Behavioral and EEG data were recorded as participants performed auditory selective attention tasks. Simulations that modulated processes of distractor inhibition accounted well for reaction-time (RT performance, whereas those that modulated target excitation did not. A model that incorporated RP from actual EEG recordings in estimating distractor inhibition was superior in predicting changes in RT as a function of distractor salience across conditions. A model that additionally incorporated momentary fluctuations in EEG as the source of trial-to-trial variation in performance precisely predicted individual RTs within each condition. The results lend support to the linking proposition that RP controls the speed of responding to targets through the inhibitory control of distractors.

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

    Science.gov (United States)

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

    2014-06-03

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

  17. Trial frequency effects in human temporal bisection: implications for theories of timing.

    Science.gov (United States)

    Jozefowiez, Jeremie; Polack, Cody W; Machado, Armando; Miller, Ralph R

    2014-01-01

    To contrast the classic version of the Scalar Expectancy Theory (SET) with the Behavioral Economic Model (BEM), we examined the effects of trial frequency on human temporal judgments. Mathematical analysis showed that, in a temporal bisection task, SET predicts that participants should show almost exclusive preference for the response associated with the most frequent duration, whereas BEM predicts that, even though participants will be biased, they will still display temporal control. Participants learned to emit one response (R[S]) after a 1.0-s stimulus and another (R[L]) after a 1.5-s stimulus. Then the effects of varying the frequencies of the 1.0-s and 1.5-s stimuli were assessed. Results were more consistent with BEM than with SET. Overall, this research illustrates how the impact of non-temporal factors on temporal discrimination may help us to contrast associative models such as BEM with cognitive models such as SET. Deciding between these two classes of models has important implications regarding the relations between associative learning and timing. This article is part of a Special Issue entitled: Associative and Temporal Learning. Copyright © 2013 Elsevier B.V. All rights reserved.

  18. Timing of insertion of levonorgestrel-releasing intrauterine system: a randomised controlled trial.

    Science.gov (United States)

    van der Heijden, Pahh; Geomini, Pmaj; Herman, M C; Veersema, S; Bongers, M Y

    2017-01-01

    The objective was to assess whether patient-perceived pain during the insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) depends on the timing during the menstrual cycle. A stratified two-armed non-inferiority randomised controlled trial. Large teaching hospital in Veldhoven, the Netherlands. From October 2013 to May 2014, 60 nulliparous and 60 multiparous women were randomised. Eight women withdrew after randomisation and before insertion took place: therefore, data from 112 women were collected and analysed. Women were randomised to the groups 'during menstruation' (i.e. days 1-7 of menstruation) or 'outside menstruation' (i.e. any day of the cycle after menstruation without the presence of vaginal blood loss) in a ratio of 1 : 1. The primary outcome was pain during insertion, measured by the visual analogue scale (VAS, 0-100 mm). Second, we analysed ease of insertion, bleeding pattern, satisfaction, pregnancy, and expulsion rate. The follow-up time was 3 months. The mean VAS score for nulliparous women was 74 mm (95% confidence interval, 95% CI 67-81) in the 'during menstruation' group, compared with 66 mm (95% CI 59-74) in the 'outside menstruation' group (P = 0.14). The mean VAS score for multiparous women was 30 mm (95% CI 20-40) in the 'during menstruation group', compared with 43 mm (95% CI 32-53) in the 'outside menstruation' group (P = 0.08). There was no difference between the stratified 'during menstruation' group and the 'outside menstruation' group with regards to ease of insertion, satisfaction, bleeding pattern, and median spotting and bleeding days for the use of the LNG-IUS 3 months after insertion. As we did not find that the level of pain perceived during insertion was higher during menstruation, compared with outside menstruation, we conclude that the LNG-IUS can be inserted at any time during the menstrual cycle, especially in the case of nulliparous women. We conducted an RCT on time of insertion of

  19. Analytical theory of soft ground consolidation under vacuum preloading combined with electro-osmosis%真空预压联合电渗法加固软基的固结方程

    Institute of Scientific and Technical Information of China (English)

    徐伟; 刘斯宏; 王柳江; 汪俊波

    2011-01-01

    An analytical consolidation theory of soft ground under vacuum preloading combined with electro-osmosis was established based on the Terzaghi' s consolidation theory and the Esrig' s electro-osmotic consolidation theory. The analytical solutions of the excess pore water pressure of the soft ground during consolidation process were obtained.Through an example, the development of the excess pore water pressure with the time and its distribution rules between the electrodes induced by the vacuum preloading combined with electro-osmosis were analyzed. Model tests on soil samples under the vacuum preloading combined with electro-osmosis were carried out. The observed water content of the soil samples after tests agree with those derived by means of the analytical solutions of the excess pore water pressure.They have similar distribution rules, indicating that the analytical consolidation theory is rational.%在Terzaghi固结理论和Esring电渗固结理论的基础上推导真空预压联合电渗法加固软基的二维固结方程,给出了真空预压联合电渗加固过程中超静孔隙水压力的解析解.通过算例,分析了真空预压联合电渗引起的土体超静孔隙水压力随时间的发展以及在电极间的分布规律.进行了真空预压联合电渗的模型试验,试验后实测土体含水率与通过超静孔隙水压力解析解推算出的含水率基本吻合,且具有相似的分布规律,表明该固结方程是合理的.

  20. Effect of Sodium Phosphate Supplementation on Cycling Time Trial Performance and VO2 1 and 8 Days Post Loading

    Directory of Open Access Journals (Sweden)

    Cameron P. Brewer, Brian Dawson, Karen E. Wallman, Kym J. Guelfi

    2014-09-01

    Full Text Available This study examined the effect of 6 days of sodium phosphate (SP (50 mg·kg·FFM-1·day-1 or placebo (PL supplementation in trained cyclists on either 100 kJ (23.9 Kcal (~3-4 min or 250 kJ (59.7 Kcal (~10-12 min time trials performances both 1 and 8 days post-supplementation. Trials were performed in a counterbalanced crossover design, with a 28-day washout period between supplementation phases. No significant differences, moderate-large ES (d or likely (or greater smallest worthwhile change (SWC values were recorded for time to completion and mean power output on days 1 and 8 post-supplementation, both within and between SP and PL for either the 100 or 250 kJ (23.9 or 59.7 Kcal trials. In the 100 kJ (23.9 Kcal trial (only first minute VO2 tended to be higher in SP8 than both PL8 (d = 0.60; 88/10/2 SWC and SP1 (d = 0.47: 82/15/3 SWC, as was mean VO2 (PL8: d = 0.77; 93/6/1 SWC and SP1: d = 0.84; 90/8/3 SWC. No significant differences were found for heart rate, ratings of perceived exertion and blood lactate post-exercise within or between any trials, while serum phosphate values were not different before or after supplementation with SP or PL. In conclusion, this study showed a tendency for increased VO2 in a short duration (100 kJ/ 23.9 Kcal: ~3-4 min cycling test on day 8 after SP supplementation, but no differences in 100 or 250 kJ (23.9 or 59.7 Kcal time trials performances were observed.

  1. The Reliability of Running Performance in a 5 km Time Trial on a Non-motorized Treadmill.

    Science.gov (United States)

    Stevens, C J; Hacene, J; Sculley, D V; Taylor, L; Callister, R; Dascombe, B

    2015-08-01

    The purpose of the study was to establish the reliability of performance and physiological responses during a self-paced 5 km running time trial on a non-motorized treadmill. 17 male runners (age: 32±13 years, height: 177±7 cm, body mass: 71±9 kg, sum of 7 skinfolds: 55±21 mm) performed familiarization then 2 separate maximal 5 km running time trials on a non-motorized treadmill. Physiological responses measured included heart rate, oxygen uptake, expired air volume, blood lactate concentration, tissue saturation index and integrated electromyography. Running time (1,522±163 s vs. 1,519±162 s for trials 1 and 2, respectively) demonstrated a low CV of 1.2% and high ICC of 0.99. All physiological variables had CVs of less than 4% and ICCs of >0.92, with the exception of blood lactate concentration (7.0±2 mmol·L(-1) vs. 6.5±1.5 mmol·L(-1) for trials 1 and 2, respectively; CV: 12%, ICC: 0.83) and the electromyography measures (CV: 8-27%, ICC: 0.71-0.91). The data demonstrate that performance time in a 5 km running time trial on a non-motorized treadmill is a highly reliable test. Most physiological responses measured across the 5 km run also demonstrated good reliability.

  2. Screen-time Weight-loss Intervention Targeting Children at Home (SWITCH: A randomized controlled trial study protocol

    Directory of Open Access Journals (Sweden)

    Tsai Midi

    2011-06-01

    Full Text Available Abstract Background Approximately one third of New Zealand children and young people are overweight or obese. A similar proportion (33% do not meet recommendations for physical activity, and 70% do not meet recommendations for screen time. Increased time being sedentary is positively associated with being overweight. There are few family-based interventions aimed at reducing sedentary behavior in children. The aim of this trial is to determine the effects of a 24 week home-based, family oriented intervention to reduce sedentary screen time on children's body composition, sedentary behavior, physical activity, and diet. Methods/Design The study design is a pragmatic two-arm parallel randomized controlled trial. Two hundred and seventy overweight children aged 9-12 years and primary caregivers are being recruited. Participants are randomized to intervention (family-based screen time intervention or control (no change. At the end of the study, the control group is offered the intervention content. Data collection is undertaken at baseline and 24 weeks. The primary trial outcome is child body mass index (BMI and standardized body mass index (zBMI. Secondary outcomes are change from baseline to 24 weeks in child percentage body fat; waist circumference; self-reported average daily time spent in physical and sedentary activities; dietary intake; and enjoyment of physical activity and sedentary behavior. Secondary outcomes for the primary caregiver include change in BMI and self-reported physical activity. Discussion This study provides an excellent example of a theory-based, pragmatic, community-based trial targeting sedentary behavior in overweight children. The study has been specifically designed to allow for estimation of the consistency of effects on body composition for Māori (indigenous, Pacific and non-Māori/non-Pacific ethnic groups. If effective, this intervention is imminently scalable and could be integrated within existing weight

  3. Designs for clinical trials with time-to-event outcomes based on stopping guidelines for lack of benefit

    Directory of Open Access Journals (Sweden)

    Choodari-Oskooei Babak

    2011-03-01

    Full Text Available Abstract background The pace of novel medical treatments and approaches to therapy has accelerated in recent years. Unfortunately, many potential therapeutic advances do not fulfil their promise when subjected to randomized controlled trials. It is therefore highly desirable to speed up the process of evaluating new treatment options, particularly in phase II and phase III trials. To help realize such an aim, in 2003, Royston and colleagues proposed a class of multi-arm, two-stage trial designs intended to eliminate poorly performing contenders at a first stage (point in time. Only treatments showing a predefined degree of advantage against a control treatment were allowed through to a second stage. Arms that survived the first-stage comparison on an intermediate outcome measure entered a second stage of patient accrual, culminating in comparisons against control on the definitive outcome measure. The intermediate outcome is typically on the causal pathway to the definitive outcome (i.e. the features that cause an intermediate event also tend to cause a definitive event, an example in cancer being progression-free and overall survival. Although the 2003 paper alluded to multi-arm trials, most of the essential design features concerned only two-arm trials. Here, we extend the two-arm designs to allow an arbitrary number of stages, thereby increasing flexibility by building in several 'looks' at the accumulating data. Such trials can terminate at any of the intermediate stages or the final stage. Methods We describe the trial design and the mathematics required to obtain the timing of the 'looks' and the overall significance level and power of the design. We support our results by extensive simulation studies. As an example, we discuss the design of the STAMPEDE trial in prostate cancer. Results The mathematical results on significance level and power are confirmed by the computer simulations. Our approach compares favourably with methodology

  4. Analysis of classical time-trial performance and technique-specific physiological determinants in elite female cross-country skiers

    Directory of Open Access Journals (Sweden)

    Øyvind Sandbakk

    2016-08-01

    Full Text Available The present study investigated the contribution of performance on uphill, flat, and downhill sections to overall performance in an international 10-km classical time-trial in elite female cross-country skiers, as well as the relationships between performance on snow and laboratory-measured physiological variables in the double poling (DP and diagonal (DIA techniques. Ten elite female cross-country skiers were continuously measured by a global positioning system device during an international 10-km cross-country skiing time-trial in the classical technique. One month prior to the race, all skiers performed a 5-min submaximal and 3-min self-paced performance test while roller skiing on a treadmill, both in the DP and DIA techniques. The time spent on uphill (r=0.98 and flat (r=0.91 sections of the race correlated most strongly with the overall 10-km performance (both p<0.05. Approximately 56% of the racing time was spent uphill, and stepwise multiple regression revealed that uphill time explained 95.5% of the variance in overall performance (p<0.001. Distance covered during the 3-min roller-skiing test and body-mass normalized peak oxygen uptake (VO2peak in both techniques showed the strongest correlations with overall time-trial performance (r=0.66-0.78, with DP capacity tending to have greatest impact on the flat and DIA capacity on uphill terrain (all p<0.05. Our present findings reveal that the time spent uphill most strongly determine classical time-trial performance, and that the major portion of the performance differences among elite female cross-country skiers can be explained by variations in technique-specific aerobic power.

  5. Acidosis, but Not Alkalosis, Affects Anaerobic Metabolism and Performance in a 4-km Time Trial.

    Science.gov (United States)

    Correia-Oliveira, Carlos Rafaell; Lopes-Silva, João Paulo; Bertuzzi, Romulo; McConell, Glenn K; Bishop, David John; Lima-Silva, Adriano Eduardo; Kiss, Maria Augusta Peduti Dal'molin

    2017-09-01

    This study aimed to determine the effect of preexercise metabolic acidosis and alkalosis on power output (PO) and aerobic and anaerobic energy expenditure during a 4-km cycling time trial (TT). Eleven recreationally trained cyclists (V˙O2peak 54.1 ± 9.3 mL·kg·min) performed a 4-km TT 100 min after ingesting in a double-blind matter 0.15 g·kg of body mass of ammonium chloride (NH4Cl, acidosis), 0.3 g·kg of sodium bicarbonate (NaHCO3, alkalosis), or 0.15 g·kg of CaCO3 (placebo). A preliminary study (n = 7) was conducted to establish the optimal doses to promote the desirable preexercise blood pH alterations without gastrointestinal distress. Data for PO, aerobic and anaerobic energy expenditure, and blood and respiratory parameters were averaged for each 1 km and compared between conditions using two-way repeated-measures ANOVA (condition and distance factors). Gastrointestinal discomfort was analyzed qualitatively. Compared with placebo (pH 7.37 ± 0.02, [HCO3]: 27.5 ± 2.6 mmol·L), the NaHCO3 ingestion resulted in a preexercise blood alkalosis (pH +0.06 ± 0.04, [HCO3]: +4.4 ± 2.0 mmol·L, P acidosis (pH -0.05 ± 0.03, [HCO3]: -4.8 ± 2.1 mmol·L, P 0.05). Minimal gastrointestinal distress was noted in all conditions. Preexercise acidosis, but not alkalosis, affects anaerobic metabolism and PO during a 4-km cycling TT.

  6. Guidelines for time-to-event end-point definitions in trials for pancreatic cancer. Results of the DATECAN initiative (Definition for the Assessment of Time-to-event End-points in CANcer trials).

    Science.gov (United States)

    Bonnetain, Franck; Bonsing, Bert; Conroy, Thierry; Dousseau, Adelaide; Glimelius, Bengt; Haustermans, Karin; Lacaine, François; Van Laethem, Jean Luc; Aparicio, Thomas; Aust, Daniela; Bassi, Claudio; Berger, Virginie; Chamorey, Emmanuel; Chibaudel, Benoist; Dahan, Laeticia; De Gramont, Aimery; Delpero, Jean Robert; Dervenis, Christos; Ducreux, Michel; Gal, Jocelyn; Gerber, Erich; Ghaneh, Paula; Hammel, Pascal; Hendlisz, Alain; Jooste, Valérie; Labianca, Roberto; Latouche, Aurelien; Lutz, Manfred; Macarulla, Teresa; Malka, David; Mauer, Muriel; Mitry, Emmanuel; Neoptolemos, John; Pessaux, Patrick; Sauvanet, Alain; Tabernero, Josep; Taieb, Julien; van Tienhoven, Geertjan; Gourgou-Bourgade, Sophie; Bellera, Carine; Mathoulin-Pélissier, Simone; Collette, Laurence

    2014-11-01

    Using potential surrogate end-points for overall survival (OS) such as Disease-Free- (DFS) or Progression-Free Survival (PFS) is increasingly common in randomised controlled trials (RCTs). However, end-points are too often imprecisely defined which largely contributes to a lack of homogeneity across trials, hampering comparison between them. The aim of the DATECAN (Definition for the Assessment of Time-to-event End-points in CANcer trials)-Pancreas project is to provide guidelines for standardised definition of time-to-event end-points in RCTs for pancreatic cancer. Time-to-event end-points currently used were identified from a literature review of pancreatic RCT trials (2006-2009). Academic research groups were contacted for participation in order to select clinicians and methodologists to participate in the pilot and scoring groups (>30 experts). A consensus was built after 2 rounds of the modified Delphi formal consensus approach with the Rand scoring methodology (range: 1-9). For pancreatic cancer, 14 time to event end-points and 25 distinct event types applied to two settings (detectable disease and/or no detectable disease) were considered relevant and included in the questionnaire sent to 52 selected experts. Thirty experts answered both scoring rounds. A total of 204 events distributed over the 14 end-points were scored. After the first round, consensus was reached for 25 items; after the second consensus was reached for 156 items; and after the face-to-face meeting for 203 items. The formal consensus approach reached the elaboration of guidelines for standardised definitions of time-to-event end-points allowing cross-comparison of RCTs in pancreatic cancer. Copyright © 2014 Elsevier Ltd. All rights reserved.

  7. Effect of Sodium Phosphate Supplementation on Cycling Time Trial Performance and VO2 1 and 8 Days Post Loading.

    Science.gov (United States)

    Brewer, Cameron P; Dawson, Brian; Wallman, Karen E; Guelfi, Kym J

    2014-09-01

    This study examined the effect of 6 days of sodium phosphate (SP) (50 mg·kg·FFM(-1)·day(-1)) or placebo (PL) supplementation in trained cyclists on either 100 kJ (23.9 Kcal) (~3-4 min) or 250 kJ (59.7 Kcal) (~10-12 min) time trials performances both 1 and 8 days post-supplementation. Trials were performed in a counterbalanced crossover design, with a 28-day washout period between supplementation phases. No significant differences, moderate-large ES (d) or likely (or greater) smallest worthwhile change (SWC) values were recorded for time to completion and mean power output on days 1 and 8 post-supplementation, both within and between SP and PL for either the 100 or 250 kJ (23.9 or 59.7 Kcal) trials. In the 100 kJ (23.9 Kcal) trial (only) first minute VO2 tended to be higher in SP8 than both PL8 (d = 0.60; 88/10/2 SWC) and SP1 (d = 0.47: 82/15/3 SWC), as was mean VO2 (PL8: d = 0.77; 93/6/1 SWC and SP1: d = 0.84; 90/8/3 SWC). No significant differences were found for heart rate, ratings of perceived exertion and blood lactate post-exercise within or between any trials, while serum phosphate values were not different before or after supplementation with SP or PL. In conclusion, this study showed a tendency for increased VO2 in a short duration (100 kJ/ 23.9 Kcal: ~3-4 min) cycling test on day 8 after SP supplementation, but no differences in 100 or 250 kJ (23.9 or 59.7 Kcal) time trials performances were observed. Key PointsStudies investigating the effects of sodium phosphate loading on shorter duration (ergogenic effect may last.Loading did not improve cycling time trial (~3-4 min and 10-12 min) performance either 1 or 8 days after supplementation.Future studies should investigate the effect of sodium phosphate loading on repeated sprints and simulated cycling road race performance over extended durations (>30 min), where it may be likely to have a more beneficial effect.

  8. Rationale and study design for a randomised controlled trial to reduce sedentary time in adults at risk of type 2 diabetes mellitus: project stand (Sedentary Time ANd diabetes

    Directory of Open Access Journals (Sweden)

    Wilmot Emma G

    2011-12-01

    Full Text Available Abstract Background The rising prevalence of Type 2 Diabetes Mellitus (T2DM is a major public health problem. There is an urgent need for effective lifestyle interventions to prevent the development of T2DM. Sedentary behaviour (sitting time has recently been identified as a risk factor for diabetes, often independent of the time spent in moderate-to-vigorous physical activity. Project STAND (Sedentary Time ANd Diabetes is a study which aims to reduce sedentary behaviour in younger adults at high risk of T2DM. Methods/Design A reduction in sedentary time is targeted using theory driven group structured education. The STAND programme is subject to piloting and process evaluation in line with the MRC framework for complex interventions. Participants are encouraged to self-monitor and self-regulate their behaviour. The intervention is being assessed in a randomised controlled trial with 12 month follow up. Inclusion criteria are a aged 18-40 years with a BMI in the obese range; b 18-40 years with a BMI in the overweight range plus an additional risk factor for T2DM. Participants are randomised to the intervention (n = 89 or control (n = 89 arm. The primary outcome is a reduction in sedentary behaviour at 12 months as measured by an accelerometer (count Conclusions This is the first UK trial to address sedentary behaviour change in a population of younger adults at risk of T2DM. The results will provide a platform for the development of a range of future multidisciplinary interventions in this rapidly expanding high-risk population. Trial registration Current controlled trials ISRCTN08434554, MRC project 91409.

  9. Alternative Calculations of Individual Patient Time in Therapeutic Range While Taking Warfarin: Results From the ROCKET AF Trial

    Science.gov (United States)

    Singer, Daniel E.; Hellkamp, Anne S.; Yuan, Zhong; Lokhnygina, Yuliya; Patel, Manesh R.; Piccini, Jonathan P.; Hankey, Graeme J.; Breithardt, Günter; Halperin, Jonathan L.; Becker, Richard C.; Hacke, Werner; Nessel, Christopher C.; Mahaffey, Kenneth W.; Fox, Keith A. A.; Califf, Robert M.

    2015-01-01

    Background In the ROCKET AF (Rivaroxaban–Once‐daily, oral, direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) trial, marked regional differences in control of warfarin anticoagulation, measured as the average individual patient time in the therapeutic range (iTTR) of the international normalized ratio (INR), were associated with longer inter‐INR test intervals. The standard Rosendaal approach can produce biased low estimates of TTR after an appropriate dose change if the follow‐up INR test interval is prolonged. We explored the effect of alternative calculations of TTR that more immediately account for dose changes on regional differences in mean iTTR in the ROCKET AF trial. Methods and Results We used an INR imputation method that accounts for dose change. We compared group mean iTTR values between our dose change–based method with the standard Rosendaal method and determined that the differences between approaches depended on the balance of dose changes that produced in‐range INRs (“corrections”) versus INRs that were out of range in the opposite direction (“overshoots”). In ROCKET AF, the overall mean iTTR of 55.2% (Rosendaal) increased up to 3.1% by using the dose change–based approach, depending on assumptions. However, large inter‐regional differences in anticoagulation control persisted. Conclusions TTR, the standard measure of control of warfarin anticoagulation, depends on imputing daily INR values for the vast majority of follow‐up days. Our TTR calculation method may better reflect the impact of warfarin dose changes than the Rosendaal approach. In the ROCKET AF trial, this dose change–based approach led to a modest increase in overall mean iTTR but did not materially affect the large inter‐regional differences previously reported. Clinical Trial Registration URL: ClinicalTrials.gov. Unique identifier: NCT00403767. PMID:25736441

  10. Pre-meal video game playing and a glucose preload suppress food intake in normal weight boys.

    Science.gov (United States)

    Branton, Alyson; Akhavan, Tina; Gladanac, Branka; Pollard, Damion; Welch, Jo; Rossiter, Melissa; Bellissimo, Nick

    2014-12-01

    Increased food intake (FI) during television viewing has been reported in children, but it is unknown if this occurs following pre-meal video game playing (VGP). The objective was to determine the effect of pre-meal VGP for 30 min on subjective appetite and emotions, and FI in normal weight (NW) boys after a glucose or control preload. On four test mornings, NW boys (n = 19) received equally sweetened preloads of a non-caloric sucralose control or 50 g glucose in 250 mL of water, with or without VGP for 30 min. Food intake from an ad libitum pizza meal was measured immediately after. Subjective appetite was measured at 0, 15, 30, and 60 min. Subjective emotions were determined by visual analog scale at baseline and immediately before lunch. Both VGP (p = 0.023) and glucose (p decreased FI by 59 and 170 kcal, respectively. Subjective average appetite increased to 30 min (p = 0.003), but was lower after glucose (p = 0.01) in both the VGP and no-VGP conditions compared with the control. Frustration and aggression scores increased after VGP (p <0.05), but did not correlate with FI. However, baseline and pre-meal happiness and excitement scores were inversely associated with FI. In conclusion, both pre-meal VGP and the glucose preload suppressed FI, supporting the roles of both physiologic and environmental factors in the regulation of short-term FI in 9- to 14-year-old NW boys.

  11. RV Myocardial Strain During Pre-Load Augmentation Is Associated With Exercise Capacity in Patients With Chronic HF.

    Science.gov (United States)

    Kusunose, Kenya; Yamada, Hirotsugu; Nishio, Susumu; Ishii, Ayumi; Hirata, Yukina; Seno, Hiromitsu; Saijo, Yoshihito; Ise, Takayuki; Yamaguchi, Koji; Yagi, Shusuke; Soeki, Takeshi; Wakatsuki, Tetsuzo; Sata, Masataka

    2017-07-13

    The aim of this study was to assess the relationship between right ventricular (RV) function during pre-load augmentation and exercise tolerance. Peak oxygen uptake (VO2) is a strong predictor of mortality in chronic heart failure. Cardiac function during pre-load augmentation is an important part of the phenomenon in the evaluation of exercise capacity. We prospectively performed echocardiographic studies in 68 chronic heart failure patients with cardiopulmonary exercise testing (mean age 60 ± 12 years; 69% male). After resting evaluations, echocardiographic parameters were repeated during leg positive pressure (LPP). Exercise capacity was assessed by peak VO2 in all patients (left ventricular ejection fraction: 43 ± 15%). Patients with severely reduced exercise capacity (peak VO2 <14 ml/kg/min) had significantly lower stroke volume index, left ventricular global longitudinal strain and RV strain and higher filling pressure (E/e' and pulmonary arterial systolic pressure) than the remainder. Stroke volume index (β = 0.49), global longitudinal strain (β = -0.61), E/e' (β = -0.32), pulmonary arterial systolic pressure (β = -0.57), and RV strain (β = -0.66) during LPP were independently correlated to peak VO2 (all p < 0.01). RV strain during LPP was the most powerful predictor in identifying patients with severely reduced exercise capacity (cut off value: -17%; sensitivity: 81%; specificity: 88%; areas under the curve: 0.88, p < 0.001) compared with other variables including resting parameters. RV strain during pre-load augmentation correlated independently to peak VO2 and was a powerful predictor in identifying patients with severely reduced exercise capacity. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  12. Effect of Preload Alterations on Left Ventricular Systolic Parameters Including Speckle-Tracking Echocardiography Radial Strain During General Anesthesia.

    Science.gov (United States)

    Weber, Ulrike; Base, Eva; Ristl, Robin; Mora, Bruno

    2015-08-01

    Frequently used parameters for evaluation of left ventricular systolic function are load-sensitive. However, the impact of preload alterations on speckle-tracking echocardiographic parameters during anesthesia has not been validated. Therefore, two-dimensional (2D) speckle-tracking echocardiography radial strain (RS) was assessed during general anesthesia, simulating 3 different preload conditions. Single-center prospective observational study. University hospital. Thirty-three patients with normal left ventricular systolic function undergoing major surgery. Transgastric views of the midpapillary level of the left ventricle were acquired at 3 different positions. Fractional shortening (FS), fractional area change (FAC), and 2D speckle-tracking echocardiography RS were analyzed in the transgastric midpapillary view. Considerable correlation above 0.5 was found for FAC and FS in the zero and Trendelenburg positions (r = 0.629, r = 0.587), and for RS and FAC in the anti-Trendelenburg position (r = 0.518). In the repeated-measures analysis, significant differences among the values measured at the 3 positions were found for FAC and FS. For FAC, there were differences up to 2.8 percentage points between the anti-Trendelenburg position and the other 2 positions. For FS, only the difference between position zero and anti-Trendelenburg was significant, with an observed change of 1.66. Two-dimensional RS was not significantly different at all positions, with observed changes below 1 percentage point. Alterations in preload did not result in clinically relevant changes of RS, FS, or FAC. Observed changes for RS were smallest; however, the variation of RS was larger than that of FS or FAC. Copyright © 2015 Elsevier Inc. All rights reserved.

  13. Time-to-event continual reassessment method incorporating treatment cycle information with application to an oncology phase I trial.

    Science.gov (United States)

    Huang, Bo; Kuan, Pei Fen

    2014-11-01

    Delayed dose limiting toxicities (i.e. beyond first cycle of treatment) is a challenge for phase I trials. The time-to-event continual reassessment method (TITE-CRM) is a Bayesian dose-finding design to address the issue of long observation time and early patient drop-out. It uses a weighted binomial likelihood with weights assigned to observations by the unknown time-to-toxicity distribution, and is open to accrual continually. To avoid dosing at overly toxic levels while retaining accuracy and efficiency for DLT evaluation that involves multiple cycles, we propose an adaptive weight function by incorporating cyclical data of the experimental treatment with parameters updated continually. This provides a reasonable estimate for the time-to-toxicity distribution by accounting for inter-cycle variability and maintains the statistical properties of consistency and coherence. A case study of a First-in-Human trial in cancer for an experimental biologic is presented using the proposed design. Design calibrations for the clinical and statistical parameters are conducted to ensure good operating characteristics. Simulation results show that the proposed TITE-CRM design with adaptive weight function yields significantly shorter trial duration, does not expose patients to additional risk, is competitive against the existing weighting methods, and possesses some desirable properties. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  14. Analysis of Classical Time-Trial Performance and Technique-Specific Physiological Determinants in Elite Female Cross-Country Skiers.

    Science.gov (United States)

    Sandbakk, Øyvind; Losnegard, Thomas; Skattebo, Øyvind; Hegge, Ann M; Tønnessen, Espen; Kocbach, Jan

    2016-01-01

    The present study investigated the contribution of performance on uphill, flat, and downhill sections to overall performance in an international 10-km classical time-trial in elite female cross-country skiers, as well as the relationships between performance on snow and laboratory-measured physiological variables in the double poling (DP) and diagonal (DIA) techniques. Ten elite female cross-country skiers were continuously measured by a global positioning system device during an international 10-km cross-country skiing time-trial in the classical technique. One month prior to the race, all skiers performed a 5-min submaximal and 3-min self-paced performance test while roller skiing on a treadmill, both in the DP and DIA techniques. The time spent on uphill (r = 0.98) and flat (r = 0.91) sections of the race correlated most strongly with the overall 10-km performance (both p skiing test and body-mass normalized peak oxygen uptake (VO2peak) in both techniques showed the strongest correlations with overall time-trial performance (r = 0.66-0.78), with DP capacity tending to have greatest impact on the flat and DIA capacity on uphill terrain (all p cross-country skiers can be explained by variations in technique-specific aerobic power.

  15. Direct Laryngoscopy and Endotracheal Intubation Complicated by Anterior Tracheal Laceration Secondary to Protrusion of Preloaded Endotracheal Tube Stylet.

    Science.gov (United States)

    Warner, Matthew A; Fox, Jonathan F

    2016-02-15

    Tracheal wall disruption is a rare complication of endotracheal intubation, typically occurring in the posterior (membranous) trachea lacking cartilaginous support. We present the case of a 68-year-old man who developed an anterior tracheal tear after routine endotracheal intubation, most likely occurring secondary to protrusion of a factory-preloaded stylet beyond the distal orifice of the endotracheal tube. Tracheal disruption should be considered in any patient with subcutaneous emphysema and respiratory distress after tracheal extubation and confirmed with bronchoscopy. Conservative management may be appropriate for those with small tears, hemodynamic stability, and the ability to isolate the tear from positive pressure ventilation.

  16. FE-MODELLING OF A CONTACT LAYER BETWEEN ELEMENTS JOINED IN PRELOADED BOLTED CONNECTIONS FOR THE OPERATIONAL CONDITION

    Directory of Open Access Journals (Sweden)

    Rafał Grzejda

    2014-11-01

    Full Text Available Modelling and calculations of a contact layer between elements joined in a preloaded bolted connection for the operational condition are presented. The physical model of the bolted connection is based on a flexible flange element that is joined with a rigid support by means of the no-bolt model (at the assembly stage or the rigid body bolt model (at the operational stage. The contact layer between joined elements is described as the nonlinear Winkler model. The contact joint model considering an experimental normal elastic characteristic is presented. Examples of normal contact pressure and normal contact deformations distributions are contained.

  17. Observer bias in randomized clinical trials with time-to-event outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida;

    2014-01-01

    intravenous administration of the same drug, resulting in bias favouring the control intervention, RHR 1.33 (0.98 to 1.82). Seven trials of cytomegalovirus retinitis, tibial fracture and multiple sclerosis compared experimental interventions with standard control interventions, e.g. placebo, no...

  18. What Are Clinical Trials?

    Science.gov (United States)

    ... of this page please turn Javascript on. Feature: Clinical Trials What Are Clinical Trials? Past Issues / Fall 2010 Table of Contents Clinical ... conducted all the time. The Different Phases of Clinical Trials Clinical trials related to drugs are classified into ...

  19. Stopping rules employing response rates, time to progression, and early progressive disease for phase II oncology trials

    Directory of Open Access Journals (Sweden)

    Goffin John R

    2011-12-01

    Full Text Available Abstract Background Response rate (RR, the most common early means of assessing oncology drugs, is not suitable as the sole endpoint for phase II trials of drugs which induce disease stability but not regression. Time to progression (TTP may be more sensitive to such agents, but induces recruitment delays in multistage studies. Early progressive disease (EPD is the earliest signal of time to progression, but is less intuitive to investigators, To study drugs with unknown anti-tumour effect, we designed the Combination Stopping Rule (CSR, which allows investigators to establish a hypothesis using RR and TTP, while the program also employs early progressive disease (EPD to assess for drug inactivity during the first stage of study accrual. Methods A computer program was created to generate stopping rules based on specified error rates, trial size, and RR and median TTP of interest and disinterest for a two-stage phase II trial. Rules were generated for stage II such that the null hypothesis (Hnul was rejected if either RR or TTP met desired thresholds, and accepted if both did not. Assuming an exponential distribution for progression, EPD thresholds were determined based on specified TTP values. Stopping rules were generated for stage I such that Hnul was accepted and the study stopped if both RR and EPD were unacceptable. Results Patient thresholds were generated for RR, median TTP, and EPD which achieved specified error rates and which allowed early stopping based on RR and EPD. For smaller proportional differences between interesting and disinteresting values of RR or TTP, larger trials are required to maintain alpha error, and early stopping is more common with a larger first stage. Conclusion Stopping rules are provided for phase II trials for drugs which have either a desirable RR or TTP. In addition, early stopping can be achieved using RR and EPD.

  20. “Watching time tick by…”: Decision making for Duchenne muscular dystrophy trials

    Science.gov (United States)

    Peay, Holly L; Scharff, Hadar; Tibben, Aad; Wilfond, Benjamin; Bowie, Janice; Johnson, Joanna; Nagaraju, Kanneboyina; Escolar, Diana; Piacentino, Jonathan; Biesecker, Barbara B

    2015-01-01

    Objective This interview study explored clinicians’ perspectives and parents’ decision making about children’s participation in Duchenne muscular dystrophy (DMD) clinical trials. Methods Data from semi-structured interviews conducted with clinicians and parents in U.S. or Canada were assessed using thematic analysis. Results Eleven clinicians involved in ten trials and fifteen parents involved in six trials were interviewed. Parents described benefit-risk assessments using information from advocacy, peers, professionals, and sponsors. Strong influence was attributed to the progressive nature of DMD. Most expected direct benefit. Few considered the possibility of trial failure. Most made decisions to participate before the informed consent (IC) process, but none-the-less perceived informed choice with little to lose for potential gain. Clinicians described more influence on parental decisions than attributed by parents. Clinicians felt responsible to facilitate IC while maintaining hope. Both clinicians and parents reported criticisms about the IC process and regulatory barriers. Conclusions The majority of parents described undertaking benefit-risk assessments that led to informed choices that offered psychological and potential disease benefits. Parents’ high expectations influenced their decisions while also reflecting optimism. Clinicians felt challenged in balancing parents’ expectations and likely outcomes. Prognosis-related pressures coupled with decision making prior to IC suggest an obligation to ensure educational materials are understandable and accurate, and to consider an expanded notion of IC timeframes. Anticipatory guidance about potential trial failure might facilitate parents’ deliberations while aiding clinicians in moderating overly-optimistic motivations. Regulators and industry should appreciate special challenges in progressive disorders, where doing nothing was equated with doing harm. PMID:26546066

  1. Minor amounts of plasma medium-chain fatty acids and no improved time trial performance after consuming lipids

    DEFF Research Database (Denmark)

    Vistisen, Bodil; Nybo, L.; Xu, Xuebing;

    2003-01-01

    % of maximum 02 uptake during which they ingested CHO or CHO plus specific structured triacylglycerols. Immediately after the constant-load cycling, the subjects performed a time trial of similar to50-min duration. Breath and blood samples were obtained regularly during the experiment. Fatty acid composition...... of plasma triacylglycerols, fatty acids, and phospholipids was determined. Performance was similar after administration of CHO plus specific structured triacylglycerol [medium-, long-, and medium-chain fatty acid (MLM)] compared with CHO (50.0 +/- 1.8 and 50.8 +/- 3.6 min, respectively). No plasma 8......:0 was detected in the plasma lipid classes, but the amount of phospholipid fatty acids was significantly higher after CHO+MLM compared with CHO intake. The lacking time trial improvement after intake of medium-chain fatty acids might be due to no available 8:0 in the systemic circulation. A higher level...

  2. The fastest of three trials is recommended for Timed Up & Go testing of functional mobility in an outpatient geriatric setting

    DEFF Research Database (Denmark)

    Bloch, Mette Linding

    2012-01-01

    , using an armchair if not able to perform without). Repeated measures with Bonferoni corrections for mass significance was used to evaluate differences between TUG trials, T-Tests to evaluate differences between groups,and Pearson’s Correlation coefficient to evaluate association between variables...... to 5.5 seconds in difference between the two recordings. Subjects using walking aids (n=10) were the oldest (P=0.057, mean age of 87.7 versus 81.5 years), and performed worse (P=0.033, 26.3 versus 17.3seconds) when using the best of the three TUG trials. Also, this score was significantly correlated...... with age (r=0.434, P=0.013) and the modified CST with the use of armchair (n=15, r=-0.600,P=0.018), while no significant correlation was seen in relation to the CST (n=15, r=-0.411, P=0.128). Conclusion: We recommend that the fastest of three timed TUG trials is used instead of the second trial when...

  3. The use of a transparent cap in sigmoidoscopy-A randomized controlled clinical trial on pain, time and success rate.

    Science.gov (United States)

    Ploug, Magnus; Poulsen, Jacob Kvist; Jensen, Henning Quist; Achiam, Michael

    2017-08-01

    Trials on cap-assisted colonoscopy have shown a reduction in pain, faster intubation time and a higher success rate attributed to the use of the cap. No similar studies have been published on sigmoidoscopy even though it is a common procedure associated with significant pain. Our objective was to investigate whether the use of a transparent cap for sigmoidoscopy has an impact on pain, time or success rate. To mimic the tendencies of daily clinical practice, the trainee endoscopist performed the procedures, and no analgesics or sedatives were used. We conducted a randomized, controlled clinical trial with a parallel design consisting of two groups masked for the intervention. The primary endpoint was pain, recorded on a 100-mm visual analogue scale (VAS). Our results found cap-assisted sigmoidoscopy to be significantly more painful than non-cap-assisted sigmoidoscopy (median VAS 50 vs. 38 mm; p = 0.047). We found no differences on time or success rate due to the cap. Our results suggest pain management, e.g. analgesics which is not routinely used for sigmoidoscopy, when a cap is used to gain therapeutic or diagnostic advantages. ClinicalTrials.gov Identifier: NCT02243930.

  4. Static stretching alters neuromuscular function and pacing strategy, but not performance during a 3-km running time-trial.

    Directory of Open Access Journals (Sweden)

    Mayara V Damasceno

    Full Text Available Previous studies report that static stretching (SS impairs running economy. Assuming that pacing strategy relies on rate of energy use, this study aimed to determine whether SS would modify pacing strategy and performance in a 3-km running time-trial.Eleven recreational distance runners performed a a constant-speed running test without previous SS and a maximal incremental treadmill test; b an anthropometric assessment and a constant-speed running test with previous SS; c a 3-km time-trial familiarization on an outdoor 400-m track; d and e two 3-km time-trials, one with SS (experimental situation and another without (control situation previous static stretching. The order of the sessions d and e were randomized in a counterbalanced fashion. Sit-and-reach and drop jump tests were performed before the 3-km running time-trial in the control situation and before and after stretching exercises in the SS. Running economy, stride parameters, and electromyographic activity (EMG of vastus medialis (VM, biceps femoris (BF and gastrocnemius medialis (GA were measured during the constant-speed tests.The overall running time did not change with condition (SS 11:35±00:31 s; control 11:28±00:41 s, p = 0.304, but the first 100 m was completed at a significantly lower velocity after SS. Surprisingly, SS did not modify the running economy, but the iEMG for the BF (+22.6%, p = 0.031, stride duration (+2.1%, p = 0.053 and range of motion (+11.1%, p = 0.0001 were significantly modified. Drop jump height decreased following SS (-9.2%, p = 0.001.Static stretch impaired neuromuscular function, resulting in a slow start during a 3-km running time-trial, thus demonstrating the fundamental role of the neuromuscular system in the self-selected speed during the initial phase of the race.

  5. Treatment crossovers in time-to-event non-inferiority randomised trials of radiotherapy in patients with breast cancer

    Science.gov (United States)

    Parpia, Sameer; Julian, Jim A; Thabane, Lehana; Gu, Chushu; Whelan, Timothy J; Levine, Mark N

    2014-01-01

    Background In non-inferiority trials of radiotherapy in patients with early stage breast cancer, it is inevitable that some patients will cross over from the experimental arm to the standard arm prior to initiation of any treatment due to complexities in treatment planning or subject preference. Although the intention-to-treat (ITT) analysis is the preferred approach for superiority trials, its role in non-inferiority trials is still under debate. This has led to the use of alternative approaches such as the per-protocol (PP) analysis or the as-treated (AT) analysis, despite the inherent biases of such approaches. Methods Using simulations, we investigate the effect of 2%, 5% and 10% random and non-random crossovers prior to radiotherapy initiation on the ITT, PP, AT and the combination of ITT and PP analyses with respect to type I error in trials with time-to-event outcomes. We also evaluate bias and SE of the estimates from the ITT, PP and AT approaches. Results The AT approach had the best performance in terms of type I error, but was anticonservative as non-random crossover increased. The ITT and PP approaches were anticonservative under all percentages of random and non-random crossover. Similarly, lowest bias was seen with the AT approach; however, bias increased as the percentage of non-random crossover increased. The ITT and PP had poor performance in terms of bias as crossovers increased. Conclusions If minimal crossovers were to occur, we have shown that the AT approach has the lowest type I error rates and smallest opportunity for bias. Results of trials with a high number of crossovers should be interpreted with caution, especially when crossover is non-random. Attempts to prevent crossovers should be maximised. PMID:25344487

  6. COMPARATIVE STUDY OF 6% HYDROXYETHYL STARCH (450/0 . 7 AND RINGER’S LACTATE AS PRELOADING FLUID FOR PREVENTION OF HYPOTENSION DURING SPINAL ANESTHESIA IN ELECTIVE CESAREAN DELIVERY

    Directory of Open Access Journals (Sweden)

    Javid

    2015-09-01

    % and that in group B 23 . 3% . The mean time period of onset of hypotension in group A was 6 . 3±2 . 09 (range 4 - 10 min and that in group B was 12 . 9±2 . 27 ( R ange 10 - 16 min . The lowest systolic pressure noted in group A was 109 . 8mmHg and in group was 113 . 9mmHg . None of the patients in group A and group B had bradycardia . The mean amount of Ephedrine required in group A and group B was 13 and 9 . 4 mg respectively . The average amount of i . v fluid used intra - operatively in group A was 1200±152 . 56 ( R ange 1000 - 1500 ml and in group B was 1191 . 70±130 . 70 ( R ange 1000 - 1450 ml . The average intraoperative blood loss in group A was 837 . 50±65 . 90 ( R ange 750 - 1000 ml and in group B was 819 . 20±64 . 56 ( R ange 750 - 950 ml . 4 patients in group A and 3 patients in group B developed vomiting . The neonatal Apgar scores were good and similar in both groups . CONCLUSION : It is concluded that:Among prel oading agents, colloids are superior to crystalloids in reducing the onset and incidence of spinal - induced hypotension . Hydroxyethyl starch 6% is an ideal preloading agent . High molecular weight HEAS (e . g . 450/0 . 7 seems to be better option than Ringer’s anaesthesia in parturients scheduled for elective cesarean section . It is suggested to use 500 ml of high molecular weight 6% HEAS 450/0 . 7 as an effective prophylactic measure to reduce the incidence of spinal - induced hypotension in parturients planned for elective cesarean section . Also no allergic reaction with 6% HEAS 450/0 . 7 were observed in our study

  7. Time-dependent effects of post-trial amphetamine treatment in rats: evidence for enhanced storage of representational memory.

    Science.gov (United States)

    Strupp, B J; Bunsey, M; Levitsky, D; Kesler, M

    1991-07-01

    Two studies were conducted to test the ability of post-trial amphetamine treatment to improve later recall in a nonaversively motivated task. These studies utilized 8- and 12-arm radial mazes, respectively, with an 11-h retention interval imposed after the rat traversed half the arms of the maze (termed, the to-be-remembered-event, or TBRE). In Experiment 1, the rats were injected with amphetamine (0, .25, and .50 mg/kg) immediately after the TBRE. Because the drug treatment improved retention, a time dependency study was conducted in which the drug (0 and .33 mg/kg) was administered 0, 3, and 6 h after the TBRE. The finding that amphetamine injection at 0, but not 3, h post-trial improved later recall indicates that the benefit derived from the former treatment is not due to proactive influences at the time of the retention test. Drug treatment 6 h post-trial produced a borderline improvement of recall; possible mechanisms are discussed. Two conclusions can be drawn from these results: (1) amphetamine administration can improve recall under conditions in which this effect cannot be attributed to alterations in information processing during either the learning or the retention sessions, indicating that the drug modulates memory storage processes; and (2) amphetamine treatment can improve working memory, thus excluding an alternative interpretation for the previous reports of impaired short-term memory in animals, all of which entailed assessments of working memory. The possibility remains, however, that the impairment seen in these tasks reflects the requirement for erasure of information from previous trials within each daily session, rather than the duration of the retention interval.

  8. Time trial: A prospective comparative study of the time-resource burden for three-dimensional conformal radiotherapy and intensity-modulated radiotherapy in head and neck cancers

    Directory of Open Access Journals (Sweden)

    Murthy Vedang

    2009-01-01

    Full Text Available Introduction: An ongoing institutional randomized clinical trial comparing three-dimensional conformal radiotherapy (3D CRT and intensity-modulated radiotherapy (IMRT provided us an opportunity to document and compare the time-manpower burden with these high-precision techniques in head and neck cancers. Materials and Methods: A cohort of 20 consecutive patients in the ongoing trial was studied. The radiotherapy planning and delivery process was divided into well-defined steps and allocated human resource based on prevalent departmental practice. Person-hours for each step were calculated. Results: Twelve patients underwent IMRT and eight patients had 3D CRT. The prerandomization steps (upto and including approval of contours were common between the two arms, and expectedly, the time taken to complete each step was similar. The planning step was carried out postrandomization and the median times were similar for 3D CRT (312 min, 5.2 person-hours and IMRT (325.6 min, 5.4 person-hours. The median treatment delivery time taken per fraction varied between the two arms, with 3D CRT taking 15.2 min (0.6 person-hours, while IMRT taking 27.8 min (0.9 person-hours (P< 0.001. The total treatment time was also significantly longer in the IMRT arm (median 27.7 versus 17.8 person-hours, P< 0.001. The entire process of IMRT took 48.5 person-hours while 3D CRT took a median of 37.3 person-hours. The monitor units delivered per fraction and the actual "beam-on" time was also statistically longer with IMRT. Conclusions: IMRT required more person-hours than 3D CRT, the main difference being in the time taken to deliver the step-and-shoot IMRT and the patient-specific quality assurance associated with IMRT.

  9. FLUID INGESTION STRATEGIES OF COMPETITIVE CYCLISTS DURING 40 KM TIME TRIAL COMPETITION

    Directory of Open Access Journals (Sweden)

    Karianne Backx

    2007-12-01

    Full Text Available Dear Editor-in- ChiefLoss of fluid during prolonged exercise has been purported to be a cause of fatigue (Below et al., 1995; Walsh et al., 1994, for example. A plethora of information regarding 'optimal' fluid replacement strategies exists; perhaps the most prominent of these in the public domain is the position stand on exercise and fluid replacement published by the American College of Sports Medicine (ACSM. It recommends that one should ingest fluid early and continually at regular intervals in an attempt to replace the volume of fluid lost through sweating or consume as much as can be tolerated (Covertino et al., 1996. Drinking practices associated with different types of endurance activity are not well documented and it may be possible that the guidelines based on empirical data derived from laboratory conditions lack the necessary ecological validity for performance in the field. To our knowledge, there are no data on fluid intake or body mass losses during high-intensity cycling time trials (TT outside of laboratory conditions; although a pilot study questionnaire used by El-Sayed et al., 1997 revealed that the volume ingested in pre-race preparation over a similar TT race distance (46 km ranged between 0.125-0.5 L. Therefore the aim of this investigation was to elucidate the fluid ingestion strategies of competitive cyclists during pre-race preparation and 40 km TT competition and the resultant body mass loss.Seventy-two competitive male cyclists ranging from Elite Category to Category 4 cyclists (according to British Cycling classification volunteered to participated in this investigation from two separate 40 km TT (n = 21 and n = 51, respectively. Mean (±SD body mass, height and age for all participants were 73.4 ± 7.5 kg, 1.77 ± 0.06 m, and 47 ± 13 years. All procedures were approved by the University's Research Ethics Committee and subjects completed informed consent prior to the start of the investigation.Both events were held

  10. Positive outcomes influence the rate and time to publication, but not the impact factor of publications of clinical trial results.

    Directory of Open Access Journals (Sweden)

    Pilar Suñé

    Full Text Available OBJECTIVES: Publication bias may affect the validity of evidence based medical decisions. The aim of this study is to assess whether research outcomes affect the dissemination of clinical trial findings, in terms of rate, time to publication, and impact factor of journal publications. METHODS AND FINDINGS: All drug-evaluating clinical trials submitted to and approved by a general hospital ethics committee between 1997 and 2004 were prospectively followed to analyze their fate and publication. Published articles were identified by searching Pubmed and other electronic databases. Clinical study final reports submitted to the ethics committee, final reports synopses available online and meeting abstracts were also considered as sources of study results. Study outcomes were classified as positive (when statistical significance favoring experimental drug was achieved, negative (when no statistical significance was achieved or it favored control drug and descriptive (for non-controlled studies. Time to publication was defined as time from study closure to publication. A survival analysis was performed using a Cox regression model to analyze time to publication. Journal impact factors of identified publications were recorded. Publication rate was 48·4% (380/785. Study results were identified for 68·9% of all completed clinical trials (541/785. Publication rate was 84·9% (180/212 for studies with results classified as positive and 68·9% (128/186 for studies with results classified as negative (p<0·001. Median time to publication was 2·09 years (IC95 1·61-2·56 for studies with results classified as positive and 3·21 years (IC95 2·69-3·70 for studies with results classified as negative (hazard ratio 1·99 (IC95 1·55-2·55. No differences were found in publication impact factor between positive (median 6·308, interquartile range: 3·141-28·409 and negative result studies (median 8·266, interquartile range: 4·135-17·157. CONCLUSIONS

  11. Randomised Controlled Trial to determine the appropriate time to initiate peritoneal dialysis after insertion of catheter to minimise complications (Timely PD study

    Directory of Open Access Journals (Sweden)

    Fassett Robert G

    2010-06-01

    Full Text Available Abstract Background The most appropriate time to initiate dialysis after surgical insertion of Tenckhoff catheters is not clear in the literature. There is the possibility of peritoneal dialysis (PD complications such as leakage and infection if dialysis is started too soon after insertion. However, much morbidity and expense could be saved by reducing dependency on haemodialysis (HD by earlier initiation of PD post catheter insertion. Previous studies are observational and mostly compare immediate with delayed use. The primary objective is to determine the safest and shortest time interval between surgical placement of a Tenckhoff catheter and starting PD. Methods/Design This is a randomised controlled trial of patients who will start PD after insertion of Tenckhoff catheter at Royal Brisbane and Women's Hospital (RBWH or Rockhampton Base Hospital (RBH who meet the inclusion criteria. Patients will be stratified by site and diabetic status. The patients will be randomised to one of three treatment groups. Group 1 will start PD one week after Tenckhoff catheter insertion, group 2 at two weeks and group 3 at four weeks. Nurses and physicians will be blinded to the randomised allocation. The primary end point is the complication rate (leaks and infection after initiation of PD. Discussion The study will determine the most appropriate time to initiate PD after placement of a Tenckhoff catheter. Trial Registration ACTRN12610000076077

  12. Interrupted time-series analysis yielded an effect estimate concordant with the cluster-randomized controlled trial result.

    Science.gov (United States)

    Fretheim, Atle; Soumerai, Stephen B; Zhang, Fang; Oxman, Andrew D; Ross-Degnan, Dennis

    2013-08-01

    We reanalyzed the data from a cluster-randomized controlled trial (C-RCT) of a quality improvement intervention for prescribing antihypertensive medication. Our objective was to estimate the effectiveness of the intervention using both interrupted time-series (ITS) and RCT methods, and to compare the findings. We first conducted an ITS analysis using data only from the intervention arm of the trial because our main objective was to compare the findings from an ITS analysis with the findings from the C-RCT. We used segmented regression methods to estimate changes in level or slope coincident with the intervention, controlling for baseline trend. We analyzed the C-RCT data using generalized estimating equations. Last, we estimated the intervention effect by including data from both study groups and by conducting a controlled ITS analysis of the difference between the slope and level changes in the intervention and control groups. The estimates of absolute change resulting from the intervention were ITS analysis, 11.5% (95% confidence interval [CI]: 9.5, 13.5); C-RCT, 9.0% (95% CI: 4.9, 13.1); and the controlled ITS analysis, 14.0% (95% CI: 8.6, 19.4). ITS analysis can provide an effect estimate that is concordant with the results of a cluster-randomized trial. A broader range of comparisons from other RCTs would help to determine whether these are generalizable results. Copyright © 2013 Elsevier Inc. All rights reserved.

  13. Subgroup analyses in confirmatory clinical trials: time to be specific about their purposes

    Directory of Open Access Journals (Sweden)

    Julien Tanniou

    2016-02-01

    Full Text Available Abstract Background It is well recognized that treatment effects may not be homogeneous across the study population. Subgroup analyses constitute a fundamental step in the assessment of evidence from confirmatory (Phase III clinical trials, where conclusions for the overall study population might not hold. Subgroup analyses can have different and distinct purposes, requiring specific design and analysis solutions. It is relevant to evaluate methodological developments in subgroup analyses against these purposes to guide health care professionals and regulators as well as to identify gaps in current methodology. Methods We defined four purposes for subgroup analyses: (1 Investigate the consistency of treatment effects across subgroups of clinical importance, (2 Explore the treatment effect across different subgroups within an overall non-significant trial, (3 Evaluate safety profiles limited to one or a few subgroup(s, (4 Establish efficacy in the targeted subgroup when included in a confirmatory testing strategy of a single trial. We reviewed the methodology in line with this “purpose-based” framework. The review covered papers published between January 2005 and April 2015 and aimed to classify them in none, one or more of the aforementioned purposes. Results In total 1857 potentially eligible papers were identified. Forty-eight papers were selected and 20 additional relevant papers were identified from their references, leading to 68 papers in total. Nineteen were dedicated to purpose 1, 16 to purpose 4, one to purpose 2 and none to purpose 3. Seven papers were dedicated to more than one purpose, the 25 remaining could not be classified unambiguously. Purposes of the methods were often not specifically indicated, methods for subgroup analysis for safety purposes were almost absent and a multitude of diverse methods were developed for purpose (1. Conclusions It is important that researchers developing methodology for subgroup analysis

  14. Recovery from a cycling time trial is enhanced with carbohydrate-protein supplementation vs. isoenergetic carbohydrate supplementation

    Directory of Open Access Journals (Sweden)

    Lemon Peter WR

    2008-12-01

    Full Text Available Abstract Background In this study we assessed whether a liquid carbohydrate-protein (C+P supplement (0.8 g/kg C; 0.4 g/kg P ingested early during recovery from a cycling time trial could enhance a subsequent 60 min effort on the same day vs. an isoenergetic liquid carbohydrate (CHO supplement (1.2 g/kg. Methods Two hours after a standardized breakfast, 15 trained male cyclists completed a time trial in which they cycled as far as they could in 60 min (AMex using a Computrainer indoor trainer. Following AMex, subjects ingested either C+P, or CHO at 10, 60 and 120 min, followed by a standardized meal at 4 h post exercise. At 6 h post AMex subjects repeated the time trial (PMex. Results There was a significant reduction in performance for both groups in PMex versus AMex. However, performance and power decreases between PMex and AMex were significantly greater (p ≤ 0.05 with CHO (-1.05 ± 0.44 km and -16.50 ± 6.74 W vs C+P (-0.30 ± 0.50 km and -3.86 ± 6.47 W. Fat oxidation estimated from RER values was significantly greater (p ≤ 0.05 in the C+P vs CHO during the PMex, despite a higher average workload in the C+P group. Conclusion Under these experimental conditions, liquid C+P ingestion immediately after exercise increases fat oxidation, increases recovery, and improves subsequent same day, 60 min efforts relative to isoenergetic CHO ingestion.

  15. Reducing the time before consulting with symptoms of lung cancer: a randomised controlled trial in primary care.

    Science.gov (United States)

    Smith, Sarah; Fielding, Shona; Murchie, Peter; Johnston, Marie; Wyke, Sally; Powell, Rachael; Devereux, Graham; Nicolson, Marianne; Macleod, Una; Wilson, Phil; Ritchie, Lewis; Lee, Amanda J; Campbell, Neil C

    2013-01-01

    Most individuals with lung cancer have symptoms for several months before presenting to their GP. Earlier consulting may improve survival. To evaluate whether a theory-based primary care intervention increased timely consulting of individuals with symptoms of lung cancer. Open randomised controlled trial comparing intervention with usual care in two general practices in north-east Scotland. Smokers and ex-smokers aged ≥55 years were randomised to receive a behavioural intervention or usual care. The intervention comprised a single nurse consultation at participants' general practice and a self-help manual. The main outcomes were consultations within target times for individuals with new chest symptoms (≤3 days haemoptysis, ≤3 weeks other symptoms) in the year after the intervention commenced, and intentions about consulting with chest symptoms at 1 and 6 months. Two hundred and twelve participants were randomised and 206 completed the trial. The consultation rate for new chest symptoms in the intervention group was 1.19 (95% confidence interval [CI] = 0.92 to 1.53; P = 0.18) times higher than in the usual-care group and the proportion of consultations within the target time was 1.11 (95% CI = 0.41 to 3.03; P = 0.83) times higher. One month after the intervention commenced, the intervention group reported intending to consult with chest symptoms 31 days (95% CI = 7 to 54; P = 0.012) earlier than the usual care group, and at 6 months this was 25 days (95% CI = 1.5 to 48; P = 0.037) earlier. Behavioural intervention in primary care shortened the time individuals at high risk of lung disease intended to take before consulting with new chest symptoms (the secondary outcome of the study), but increases in consultation rates and the proportions of consultations within target times were not statistically significant.

  16. Cereal fibre and type 2 diabetes: time now for randomised controlled trials?

    Science.gov (United States)

    Whincup, Peter H; Donin, Angela S

    2015-07-01

    Diet and nutrition are strongly implicated in the aetiology of type 2 diabetes; low dietary fibre intake could be an important factor. Evidence from prospective observational studies has suggested that it may be low cereal fibre intake, rather than low fruit and vegetable fibre intake, which is particularly important. In this issue of Diabetologia (DOI 10.1007/s00125-015-3585-9 ) Kuijsten et al report on the prospective associations between different dietary fibre sources and type 2 diabetes risk in the European Prospective Investigation of Cancer and Nutrition (EPIC)-Interact study and set their findings in context with a meta-analysis of relevant published prospective studies. The results presented strengthen the evidence implicating cereal fibre as an important determinant of type 2 diabetes risk and suggest that randomised controlled trials examining the effect of cereal fibre supplementation on type 2 diabetes risk are now needed.

  17. Interim analysis for binary outcome trials with a long fixed follow-up time and repeated outcome assessments at pre-specified times.

    Science.gov (United States)

    Parpia, Sameer; Julian, Jim A; Gu, Chushu; Thabane, Lehana; Levine, Mark N

    2014-01-01

    In trials with binary outcomes, assessed repeatedly at pre-specified times and where the subject is considered to have experienced a failure at the first occurrence of the outcome, interim analyses are performed, generally, after half or more of the subjects have completed follow-up. Depending on the duration of accrual relative to the length of follow-up, this may be inefficient, since there is a possibility that the trial will have completed accrual prior to the interim analysis. An alternative is to plan the interim analysis after subjects have completed follow-up to a time that is less than the fixed full follow-up duration. Using simulations, we evaluated three methods to estimate the event proportion for the interim analysis in terms of type I and II errors and the probability of early stopping. We considered: 1) estimation of the event proportion based on subjects who have been followed for a pre-specified time (less than the full follow-up duration) or who experienced the outcome; 2) estimation of the event proportion based on data from all subjects that have been randomized by the time of the interim analysis; and 3) the Kaplan-Meier approach to estimate the event proportion at the time of the interim analysis. Our results show that all methods preserve and have comparable type I and II errors in certain scenarios. In these cases, we recommend using the Kaplan-Meier method because it incorporates all the available data and has greater probability of early stopping when the treatment effect exists.

  18. The impact of left ventricular preload reduction on cardiac pulsed doppler indices during hemodialysis and its relation to intra-dialysis hypotension: A pulsed doppler study

    Directory of Open Access Journals (Sweden)

    Alarrayed Sameer

    2009-01-01

    Full Text Available Fluid status in the body plays an important role on left ventricular (LV filling in patients with end-stage renal disease (ESRD on regular hemodialysis (HD, and plays a role in intra-dialysis hemo-dynamic derangement. Fifty-two patients with ESRD on regular HD, including 34 males with a mean age of 45.5 ± 13 years (range 18-72 years, were studied. All patients underwent Echo-pulsed Doppler study before and immediately after a HD session. The Echo Doppler indices noted were: LV cavity dimension and wall thickness, LV ejection fraction (LVEF%, trans-mitral early diastolic filling velocity (E wave, atrial filling diastolic velocity (A wave, E/A ratio, Deceleration Time (DT of E wave, Isovolumic relaxation time (IVRT, Aortic Velocity Integral (AVI and Inferior Vena Cava Diameter (VCD at expiration. Patients were divided into two groups according to the amount of net ultra filtrate loss after HD. Group I comprised of 25 patients with fluid loss of < 2 liters, and Group II had 27 patients with fluid loss > 2 liters. During the HD session, each patient was observed for the development of acute clinical events such as arterial hypotension (systolic BP less than 90 mmHg, chest pain and arrhythmias. There was a significant difference between the two groups in the mean values, pre- and post- HD, of reduction of E wave velocity (p< 0.01, the reduction of E/A ratio (p< 0.05, the increment in DT of E wave (p< 0.05, the reduction in AVI (p< 0.01 and the reduction of VCD (p< 0.05. There was no significant difference between the groups in the reduction of A wave velocity and the reduction of IVRT. Among the study patients, 11 (21% developed systolic hypo-tension during HD. The pre-dialysis mean values of E/A ratio and DT of E wave in patients who developed hypotension compared to those who did not was 0.7 ± 0.2 vs 1.1 ± 0.2.1 (p< 0.001 and 246 ± 40 vs 224 ± 34 msec (p< 0.05, respectively. Our study suggests that preload reduction in patients with ESRD on

  19. Effectiveness of family meetings for family caregivers on delaying time to nursing home placement of dementia patients: a randomized trial.

    Directory of Open Access Journals (Sweden)

    Karlijn J Joling

    Full Text Available BACKGROUND: Interventions relieving the burden of caregiving may postpone or prevent patient institutionalization. The objective of this study was to determine whether a family meetings intervention was superior to usual care in postponing nursing home placement of patients with dementia. METHODS: A randomized multicenter trial was conducted among 192 patients with a clinical diagnosis of dementia living at home at enrolment and their primary family caregiver. Dyads of caregivers and patients were randomized to the family meetings intervention (n = 96 or usual care (n = 96 condition. The intervention consisted of two individual sessions with the primary caregiver and four family counseling sessions that included family members and friends. The primary outcome measure was the time until institutionalization of the patient. Intention-to-treat as well as per protocol analyses were performed. Survival analyses were carried out to evaluate the effectiveness of the intervention. RESULTS: During 18 months follow-up 23 of 96 relatives with dementia of caregivers in the intervention group and 18 of 96 relatives with dementia of caregivers in the usual care group were institutionalized. No significant difference between the intervention and the usual care group was found in time until institutionalization (adjusted hazard ratio (HR 1.46, 95% confidence interval (CI 0.78 to 2.74. The per-protocol analysis revealed no significant effect either (adjusted HR 0.57, 95% CI 0.21 to 1.57, although the number of placements among the adherers was relatively low (9.4%. A subgroup effect was found for patients' age, with a significantly higher risk of institutionalization for 'younger' patients in the intervention group compared with the usual care group (adjusted HR = 4.94, 95% CI 1.10 to 22.13. CONCLUSION: This family meetings intervention for primary caregivers of patients with dementia did not postpone patient institutionalization more than usual care. TRIAL

  20. Single and Combined Effects of Beetroot Crystals and Sodium Bicarbonate on 4-km Cycling Time Trial Performance.

    Science.gov (United States)

    Callahan, Marcus J; Parr, Evelyn B; Hawley, John A; Burke, Louise M

    2017-06-01

    When ingested alone, beetroot juice and sodium bicarbonate are ergogenic for high-intensity exercise performance. This study sought to determine the independent and combined effects of these supplements. Eight endurance trained (VO2max 65 mL·kg·min(-1)) male cyclists completed four × 4-km time trials (TT) in a doubleblind Latin square design supplementing with beetroot crystals (BC) for 3 days (15 g·day(-1) + 15 g 1 h before TT, containing 300 mg nitrate per 15 g), bicarbonate (Bi 0.3 g·kg(-1) body mass [BM] in 5 doses every 15 min from 2.5 h before TT); BC+Bi or placebo (PLA). Subjects completed TTs on a Velotron cycle ergometer under standardized laboratory conditions. Plasma nitrite concentrations were significantly elevated only in the BC+Bi trial before the TT (1520 ± 786 nmol·L(-1)) compared with baseline (665 ± 535 nmol·L(-1), p = .02) and the Bi and PLA conditions (Bi: 593 ± 203 nmol·L(-1), p .05). Blood bicarbonate concentrations were increased in the BC+Bi and Bi trials before the TT (BC+Bi: 30.9 ± 2.8 mmol·L(-1); Bi: 31.7 ± 1.1 mmol·L(-1)). There were no differences in mean power output (386-394 W) or the time taken to complete the TT (335.8-338.1 s) between any conditions. Under the conditions of this study, supplementation was not ergogenic for 4-km TT performance.

  1. Challenges, successes and patterns of enrolment in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial.

    Science.gov (United States)

    Grarup, J; Rappoport, C; Engen, N W; Carey, C; Hudson, F; Denning, E; Sharma, S; Florence, E; Vjecha, M J

    2015-04-01

    The aim of this report is to describe the challenges, successes and patterns of enrolment in the Strategic Timing of AntiRetroviral Treatment (START) study. START is a collaboration of many partners with central coordination provided by the protocol team, the statistical and data management centre (SDMC), the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) network leadership, international coordinating centres and site coordinating centres. The SDMC prepared reports on study accrual, baseline characteristics and site performance that allowed monitoring of enrolment and data quality and helped to ensure the successful enrolment of this large international trial. We describe the pattern of enrolment and challenges faced during the enrolment period of the trial. An initial pilot phase began in April 2009 and established feasibility of accrual at 101 sites. In August 2010, funding approval for an expanded definitive phase led to the successful accrual of 4688 participants from 215 sites in 35 countries by December 2013. Challenges to accrual included regulatory delays (e.g. national/local ethics approval and drug importation approval) and logistical obstacles (e.g. execution of contracts with pharmaceutical companies, setting up of a central drug repository and translation of participant materials). The personal engagement of investigators, strong central study coordination, and frequent and transparent communication with site investigators, community members and participants were key contributing factors to this success. Accrual into START was completed in a timely fashion despite multiple challenges. This success was attributable to the efforts of site investigators committed to maintaining study equipoise, transparent and responsive study coordination, and community involvement in problem-solving. © 2015 British HIV Association.

  2. Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov.

    Science.gov (United States)

    Law, Michael R; Kawasumi, Yuko; Morgan, Steven G

    2011-12-01

    Clinical trial registries are public databases created to prospectively document the methods and measures of prescription drug studies and retrospectively collect a summary of results. In 2007 the US government began requiring that researchers register certain studies and report the results on ClinicalTrials.gov, a public database of federally and privately supported trials conducted in the United States and abroad. We found that although the mandate briefly increased trial registrations, 39 percent of trials were still registered late after the mandate's deadline, and only 12 percent of completed studies reported results within a year, as required by the mandate. This result is important because there is evidence of selective reporting even among registered trials. Furthermore, we found that trials funded by industry were more than three times as likely to report results than were trials funded by the National Institutes of Health. Thus, additional enforcement may be required to ensure disclosure of all trial results, leading to a better understanding of drug safety and efficacy. Congress should also reconsider the three-year delay in reporting results for products that have been approved by the Food and Drug Administration and are in use by patients.

  3. A new nonlinear dynamic model of the rotor-bearing system considering preload and varying contact angle of the bearing

    Science.gov (United States)

    Zhang, Xuening; Han, Qinkai; Peng, Zhike; Chu, Fulei

    2015-05-01

    A great deal of research work has been done on the dynamic behaviors of the rotor-bearing system. However, the important effects of load and variation of contact angle on the bearing performance have not been focused on sufficiently. In this paper, a five-degree-of-freedom load distribution model is set up considering the bearing preload and the loads due to the rotor imbalance. Utilizing this model, the variation of the bearing contact angle is investigated thoroughly. The comparisons of the obtained contact angle against the results from literature validate that the proposed load distribution model is effective. With this model, the static ball deformations are obtained considering variation of the contact angle. Through resolving the dynamic displacements of the rotor, the dynamic ball deformations could also be obtained. Then the total restoring forces and moments of the bearings could be formulated. By introducing these nonlinear forces and moments into the rotating system, a new dynamic model considering the preload and the variation of contact angle is set up. The present analyses indicate that the bearing contact angle will be changed remarkably with the effect of bearing load. The deflection vibration of the rotor-bearing system will be underestimated without considering the varying contact angle. With the effect of varying contact angle, the ball passage frequency and its combinations with the shaft rotating frequency become more noticeable. The main resonance regions for the rotor-bearing system shift to the lower speed ranges when the variation of contact angle is taken into account.

  4. The effect of maintaining a constant preload or a constant degree of thumb abduction on the isometric twitch force of the thumb

    NARCIS (Netherlands)

    van Santen, G; Wierda, JMKH

    Objective. To investigate the effects of maintaining a constant preload and of maintaining a constant degree of thumb abduction on the isometric twitch force during mechanomyography of the thumb, we monitored neuromuscular function in patients anaesthetized without the use of a neuromuscular

  5. Research of Preloading Method for Axial Piston Pump with Swash Plate%斜盘式轴向柱塞泵预紧方式研究

    Institute of Scientific and Technical Information of China (English)

    张伟; 吉利科; 朱琳

    2015-01-01

    在斜盘式轴向柱塞泵中,通常采用弹簧对缸体与配油盘进行中心预紧,产生的预压力压紧保持架使柱塞与滑靴回程。目前常见为碟形弹簧及普通螺旋形弹簧,该文对两种弹簧进行比较,同时对使用上述两种弹簧的几种典型中心弹簧预紧方式进行比较、分析,给出在不同场合建议选用的预紧方式。%In general, the cylinder and valve plate is preloaded by spring in axial piston pump with swash plate. Meanwhile the spring can preload the retainer to make the piston and piston shoe back to the swash plate. The structure is widely used in axial piston pump. At present, the disk spring and coil spring are used often. In this paper, several typical preloading methods with the two types of spring above are dis-cussed and analyzed, and the proper preloading method is suggested in different specific applications.

  6. Increase in twitch force of the adductor pollicis muscle with stabilized preload at constant thumb abduction before and after administration of muscle relaxant

    NARCIS (Netherlands)

    van Santen, G; Wierda, JMKH; Fidler, [No Value

    1999-01-01

    Objective. To determine whether the twitch force of the adductor pollicis remains stable when 0.1 Hz single twitch stimulation is started after stabilization of the thumb preload at a constant degree of thumb abduction; also to study any possible increase in twitch force before the onset of and afte

  7. Comparison of arterial pressure and plethysmographic waveform-based dynamic preload variables in assessing fluid responsiveness and dynamic arterial tone in patients undergoing major hepatic resection

    NARCIS (Netherlands)

    Vos, J. J.; Kalmar, A. F.; Struys, M. M. R. F.; Wietasch, J. K. G.; Hendriks, H. G. D.; Scheeren, T. W. L.

    2013-01-01

    Dynamic preload variables to predict fluid responsiveness are based either on the arterial pressure waveform (APW) or on the plethysmographic waveform (PW). We compared the ability of APW-based variations in stroke volume (SVV) and pulse pressure (PPV) and of PW-based plethysmographic variability in

  8. Comparison of arterial pressure and plethysmographic waveform-based dynamic preload variables in assessing fluid responsiveness and dynamic arterial tone in patients undergoing major hepatic resection

    NARCIS (Netherlands)

    Vos, J. J.; Kalmar, A. F.; Struys, M. M. R. F.; Wietasch, J. K. G.; Hendriks, H. G. D.; Scheeren, T. W. L.

    Dynamic preload variables to predict fluid responsiveness are based either on the arterial pressure waveform (APW) or on the plethysmographic waveform (PW). We compared the ability of APW-based variations in stroke volume (SVV) and pulse pressure (PPV) and of PW-based plethysmographic variability

  9. Comparison of arterial pressure and plethysmographic waveform-based dynamic preload variables in assessing fluid responsiveness and dynamic arterial tone in patients undergoing major hepatic resection

    NARCIS (Netherlands)

    Vos, J. J.; Kalmar, A. F.; Struys, M. M. R. F.; Wietasch, J. K. G.; Hendriks, H. G. D.; Scheeren, T. W. L.

    2013-01-01

    Dynamic preload variables to predict fluid responsiveness are based either on the arterial pressure waveform (APW) or on the plethysmographic waveform (PW). We compared the ability of APW-based variations in stroke volume (SVV) and pulse pressure (PPV) and of PW-based plethysmographic variability in

  10. Onset time and haemodynamic response after thiopental vs. propofol in the elderly: a randomized trial

    DEFF Research Database (Denmark)

    Sørensen, Martin Kryspin; Dolven, T L; Rasmussen, L S

    2011-01-01

    The induction dose of hypnotic agents should be reduced in the elderly, but it is not well studied whether thiopental or propofol should be preferred in this group of patients. The aim of this study was to compare onset time, hypnosis level and the haemodynamic response after thiopental vs....... propofol for induction of anaesthesia. Our primary hypothesis was that in the elderly, thiopental had a shorter onset time than propofol, defined as time to bispectral index (BIS)...

  11. Detrended fluctuation analysis and adaptive fractal analysis of stride time data in Parkinson's disease: stitching together short gait trials.

    Science.gov (United States)

    Kirchner, Marietta; Schubert, Patric; Liebherr, Magnus; Haas, Christian T

    2014-01-01

    Variability indicates motor control disturbances and is suitable to identify gait pathologies. It can be quantified by linear parameters (amplitude estimators) and more sophisticated nonlinear methods (structural information). Detrended Fluctuation Analysis (DFA) is one method to measure structural information, e.g., from stride time series. Recently, an improved method, Adaptive Fractal Analysis (AFA), has been proposed. This method has not been applied to gait data before. Fractal scaling methods (FS) require long stride-to-stride data to obtain valid results. However, in clinical studies, it is not usual to measure a large number of strides (e.g., [Formula: see text][Formula: see text] strides). Amongst others, clinical gait analysis is limited due to short walkways, thus, FS seem to be inapplicable. The purpose of the present study was to evaluate FS under clinical conditions. Stride time data of five self-paced walking trials ([Formula: see text] strides each) of subjects with PD and a healthy control group (CG) was measured. To generate longer time series, stride time sequences were stitched together. The coefficient of variation (CV), fractal scaling exponents [Formula: see text] (DFA) and [Formula: see text] (AFA) were calculated. Two surrogate tests were performed: A) the whole time series was randomly shuffled; B) the single trials were randomly shuffled separately and afterwards stitched together. CV did not discriminate between PD and CG. However, significant differences between PD and CG were found concerning [Formula: see text] and [Formula: see text]. Surrogate version B yielded a higher mean squared error and empirical quantiles than version A. Hence, we conclude that the stitching procedure creates an artificial structure resulting in an overestimation of true [Formula: see text]. The method of stitching together sections of gait seems to be appropriate in order to distinguish between PD and CG with FS. It provides an approach to integrate FS as

  12. Relieving thermal discomfort: Effects of sprayed L-menthol on perception, performance, and time trial cycling in the heat.

    Science.gov (United States)

    Barwood, M J; Corbett, J; Thomas, K; Twentyman, P

    2015-06-01

    L-menthol stimulates cutaneous thermoreceptors and induces cool sensations improving thermal comfort, but has been linked to heat storage responses; this could increase risk of heat illness during self-paced exercise in the heat. Therefore, L-menthol application could lead to a discrepancy between behavioral and autonomic thermoregulatory drivers. Eight male participants volunteered. They were familiarized and then completed two trials in hot conditions (33.5 °C, 33% relative humidity) where their t-shirt was sprayed with CONTROL-SPRAY or MENTHOL-SPRAY after 10 km (i.e., when they were hot and uncomfortable) of a 16.1-km cycling time trial (TT). Thermal perception [thermal sensation (TS) and comfort (TC)], thermal responses [rectal temperature (Trec ), skin temperature (Tskin )], perceived exertion (RPE), heart rate, pacing (power output), and TT completion time were measured. MENTHOL-SPRAY made participants feel cooler and more comfortable and resulted in lower RPE (i.e., less exertion) yet performance was unchanged [TT completion: CONTROL-SPRAY 32.4 (2.9) and MENTHOL-SPRAY 32.7 (3.0) min]. Trec rate of increase was 1.40 (0.60) and 1.45 (0.40) °C/h after CONTROL-SPRAY and MENTHOL-SPRAY application, which were not different. Spraying L-menthol toward the end of self-paced exercise in the heat improved perception, but did not alter performance and did not increase heat illness risk.

  13. Implications of the center of rotation concept for the reconstruction of anterior column lordosis and axial preloads in spinal deformity surgery.

    Science.gov (United States)

    Koller, Heiko; Mayer, Michael; Zenner, Juliane; Resch, Herbert; Niederberger, Alfred; Fierlbeck, Johann; Hitzl, Wolfgang; Acosta, Frank L

    2012-07-01

    In thoracolumbar deformity surgery, anterior-only approaches are used for reconstruction of anterior column failures. It is generally advised that vertebral body replacements (VBRs) should be preloaded by compression. However, little is known regarding the impact of different techniques for generation of preloads and which surgical principle is best for restoration of lordosis. Therefore, the authors analyzed the effect of different surgical techniques to restore spinal alignment and lordosis as well as the ability to generate axial preloads on VBRs in anterior column reconstructions. The authors performed a laboratory study using 7 fresh-frozen specimens (from T-3 to S-1) to assess the ability for lordosis reconstruction of 5 techniques and their potential for increasing preloads on a modified distractable VBR in a 1-level thoracolumbar corpectomy. The testing protocol was as follows: 1) Radiographs of specimens were obtained. 2) A 1-level corpectomy was performed. 3) In alternating order, lordosis was applied using 1 of the 5 techniques. Then, preloads during insertion and after relaxation using the modified distractable VBR were assessed using a miniature load-cell incorporated in the modified distractable VBR. The modified distractable VBR was inserted into the corpectomy defect after lordosis was applied using 1) a lamina spreader; 2) the modified distractable VBR only; 3) the ArcoFix System (an angular stable plate system enabling in situ reduction); 4) a lordosizer (a customized instrument enabling reduction while replicating the intervertebral center of rotation [COR] according to the COR method); and 5) a lordosizer and top-loading screws ([LZ+TLS], distraction with the lordosizer applied on a 5.5-mm rod linked to 2 top-loading pedicle screws inserted laterally into the vertebra). Changes in the regional kyphosis angle were assessed radiographically using the Cobb method. The bone mineral density of specimens was 0.72 ± 22.6 g/cm(2). The maximum regional

  14. Timing of surgery for sciatica: subgroup analysis alongside a randomized trial.

    Science.gov (United States)

    Peul, Wilco C; Arts, Mark P; Brand, Ronald; Koes, Bart W

    2009-04-01

    Surgery speeds up recovery for sciatica. Prolonged conservative care with surgery for those patients with persistent sciatica however, yields similar results at 1 year. To investigate whether baseline variables modify the difference in recovery rates between these treatment strategies, baseline data of 283 patients enrolled in a randomized trial, comparing early surgery with prolonged conservative care, were used to analyse effect modification of the allotted treatment strategy. For predictors shown to modify the effect of the treatment strategy, repeated measurement analyses with the Roland Disability Questionnaire and visual analogue scale pain as continuous outcomes were performed for every level of that predictor. Presumed predictive variables did not have any interaction with treatment, while "sciatica provoked by sitting" showed to be a significant effect modifier (P = 0.07). In a Cox model we estimated a hazard ratio (HR, surgery versus conservative) of 2.2 (95% CI 1.7-3.0) in favour of surgery when sciatica was provoked by sitting, while the HR was 1.3 (95% CI 0.8-2.2) when this sign was absent. The interaction effect is marginally significant (interactions are usually tested at the 10% level) but the patterns generated by the repeated measurement analyses of all primary outcomes are completely consistent with the inferred pattern from the survival analysis. Classical signs did not show any contribution as decision support tools in deciding when to operate for sciatica, whereas treatment effects of early surgery are emphasized when sciatica is provoked by sitting and negligible when this symptom is absent.

  15. Effect of preoperative education on recovery time of laparoscopic cholecystectomy: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Leila Sadati

    2014-07-01

    Conclusion: Preoperative education of patients can significantly decrease the recovery time after laparoscopic cholecystectomy surgery. Therefore, it is strongly recommended to include the preoperative education in routine care of laparoscopic cholecystectomy patients for better surgical outcomes.

  16. Response rate, response time, and economic costs of survey research: A randomized trial of practicing pharmacists.

    Science.gov (United States)

    Hardigan, Patrick C; Popovici, Ioana; Carvajal, Manuel J

    2016-01-01

    There is a gap between increasing demands from pharmacy journals, publishers, and reviewers for high survey response rates and the actual responses often obtained in the field by survey researchers. Presumably demands have been set high because response rates, times, and costs affect the validity and reliability of survey results. Explore the extent to which survey response rates, average response times, and economic costs are affected by conditions under which pharmacist workforce surveys are administered. A random sample of 7200 U.S. practicing pharmacists was selected. The sample was stratified by delivery method, questionnaire length, item placement, and gender of respondent for a total of 300 observations within each subgroup. A job satisfaction survey was administered during March-April 2012. Delivery method was the only classification showing significant differences in response rates and average response times. The postal mail procedure accounted for the highest response rates of completed surveys, but the email method exhibited the quickest turnaround. A hybrid approach, consisting of a combination of postal and electronic means, showed the least favorable results. Postal mail was 2.9 times more cost effective than the email approach and 4.6 times more cost effective than the hybrid approach. Researchers seeking to increase practicing pharmacists' survey participation and reduce response time and related costs can benefit from the analytical procedures tested here. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. Deceptive manipulation of competitive starting strategies influences subsequent pacing, physiological status and perceptual responses during cycling time trials

    Directory of Open Access Journals (Sweden)

    Emily L Williams

    2016-11-01

    Full Text Available Little is currently known regarding competitor influence on pacing at the start of an event and in particular the subsequent effect on the remaining distance. The purpose of the present study was to investigate the influence of starting pace on the physiological and psychological responses during cycling time trials (TT utilising an innovative approach allowing pace to be accurately and dynamically replicated, as well as deceptively manipulated. Ten competitive male cyclists completed five 16.1 km TT, two baseline trials performed alone (BLs, and three with a simulated, dynamic avatar of which they were to match the pace of for the initial 4 km. The avatar represented either the cyclist’s fastest BL performance (NORM, 105% (FAST, or 95% (SLOW, of fastest BL performance (FBL. Physiological and psychological responses were measured every quartile of the TT. Despite manipulating a starting speed of ± 5% of fastest previous performance, there was no effect on overall 16.1 km TT performance. Manipulated starting strategies did however evoke different physiological and perceptual responses. Whole trial differences found that SLOW produced lower HR, VO2, BLa and RPE than FBL (p ≤ 0.03 and higher SE than FAST (p ≤ 0.03. Additionally, FAST had greater internal attention than NORM (p < 0.04. Over time all psychological and physiological variables had a significant condition x quartile interaction in the initial or second quartile mediated by the prescribed starting strategies. Furthermore, RPE, affect and internal attention remained elevated throughout FAST despite an attenuation in pace during self-selection of pace. There were no differences in performance time when manipulating a 16.1km cycling TT starting strategy. A slow start, encouraged greater positive perceptions, less negative physiological consequences than a faster start, and produces no impairment to performance time. It would therefore be considered an advantage in a non

  18. A human genotyping trial to estimate the post-feeding time from mosquito blood meals.

    Science.gov (United States)

    Hiroshige, Yuuji; Hara, Masaaki; Nagai, Atsushi; Hikitsuchi, Tomoyuki; Umeda, Mitsuo; Kawajiri, Yumi; Nakayama, Koji; Suzuki, Koichi; Takada, Aya; Ishii, Akira; Yamamoto, Toshimichi

    2017-01-01

    Mosquitoes occur almost worldwide, and females of some species feed on blood from humans and other animals to support ovum maturation. In warm and hot seasons, such as the summer in Japan, fed mosquitoes are often observed at crime scenes. The current study attempted to estimate the time that elapsed since feeding from the degree of human DNA digestion in mosquito blood meals and also to identify the individual human sources of the DNA using genotyping in two species of mosquito: Culex pipiens pallens and Aedes albopictus. After stereomicroscopic observation, the extracted DNA samples were quantified using a human DNA quantification and quality control kit and were genotyped for 15 short tandem repeats using a commercial multiplexing kit. It took about 3 days for the complete digestion of a blood meal, and genotyping was possible until 2 days post-feeding. The relative peak heights of the 15 STRs and DNA concentrations were useful for estimating the post-feeding time to approximately half a day between 0 and 2 days. Furthermore, the quantitative ratios derived from STR peak heights and the quality control kit (Q129/Q41, Q305/Q41, and Q305/Q129) were reasonably effective for estimating the approximate post-feeding time after 2-3 days. We suggest that this study may be very useful for estimating the time since a mosquito fed from blood meal DNA, although further refinements are necessary to estimate the times more accurately.

  19. Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial.

    Science.gov (United States)

    Hindricks, Gerhard; Taborsky, Milos; Glikson, Michael; Heinrich, Ullus; Schumacher, Burghard; Katz, Amos; Brachmann, Johannes; Lewalter, Thorsten; Goette, Andreas; Block, Michael; Kautzner, Josef; Sack, Stefan; Husser, Daniela; Piorkowski, Christopher; Søgaard, Peter

    2014-08-16

    An increasing number of patients with heart failure receive implantable cardioverter-defibrillators (ICDs) or cardiac resynchronisation defibrillators (CRT-Ds) with telemonitoring function. Early detection of worsening heart failure, or upstream factors predisposing to worsening heart failure, by implant-based telemonitoring might enable pre-emptive intervention and improve outcomes, but the evidence is weak. We investigated this possibility in IN-TIME, a clinical trial. We did this randomised, controlled trial at 36 tertiary clinical centres and hospitals in Australia, Europe, and Israel. We enrolled patients with chronic heart failure, NYHA class II-III symptoms, ejection fraction of no more than 35%, optimal drug treatment, no permanent atrial fibrillation, and a recent dual-chamber ICD or CRT-D implantation. After a 1 month run-in phase, patients were randomly assigned (1:1) to either automatic, daily, implant-based, multiparameter telemonitoring in addition to standard care or standard care without telemonitoring. Investigators were not masked to treatment allocation. Patients were masked to allocation unless they were contacted because of telemonitoring findings. Follow-up was 1 year. The primary outcome measure was a composite clinical score combining all-cause death, overnight hospital admission for heart failure, change in NYHA class, and change in patient global self-assessment, for the intention-to-treat population. The trial is registered with ClinicalTrials.gov, number NCT00538356. We enrolled 716 patients, of whom 664 were randomly assigned (333 to telemonitoring, 331 to control). Mean age was 65·5 years and mean ejection fraction was 26%. 285 (43%) of patients had NYHA functional class II and 378 (57%) had NYHA class III. Most patients received CRT-Ds (390; 58·7%). At 1 year, 63 (18·9%) of 333 patients in the telemonitoring group versus 90 (27·2%) of 331 in the control group (p=0·013) had worsened composite score (odds ratio 0·63, 95% CI 0·43

  20. Effectiveness of a psychosocial counselling intervention for first-time IVF couples : a randomized controlled trial

    NARCIS (Netherlands)

    de Klerk, C; Hunfeld, JAM; Duivenvoorden, HJ; den Outer, MA; Fauser, BCJM; Passchier, J; Macklon, NS

    2005-01-01

    BACKGROUND: The objective of this study was to evaluate a psychosocial counselling intervention for first-time IVF couples. In this article the results on women's distress are presented. METHODS: Two hundred sixty-five couples admitted to an IVF treatment programme at the Erasmus MC were asked to pa

  1. Onset time and haemodynamic response after thiopental vs. propofol in the elderly: a randomized trial

    DEFF Research Database (Denmark)

    Sørensen, Martin Kryspin; Dolven, T L; Rasmussen, L S

    2011-01-01

    The induction dose of hypnotic agents should be reduced in the elderly, but it is not well studied whether thiopental or propofol should be preferred in this group of patients. The aim of this study was to compare onset time, hypnosis level and the haemodynamic response after thiopental vs...

  2. Effects of low and high cadence interval training on power output in flat and uphill cycling time-trials.

    Science.gov (United States)

    Nimmerichter, Alfred; Eston, Roger; Bachl, Norbert; Williams, Craig

    2012-01-01

    This study tested the effects of low-cadence (60 rev min(-1)) uphill (Int(60)) or high-cadence (100 rev min(-1)) level-ground (Int(100)) interval training on power output (PO) during 20-min uphill (TT(up)) and flat (TT(flat)) time-trials. Eighteen male cyclists ([Formula: see text]: 58.6 ± 5.4 mL min(-1) kg(-1)) were randomly assigned to Int(60), Int(100) or a control group (Con). The interval training comprised two training sessions per week over 4 weeks, which consisted of six bouts of 5 min at the PO corresponding to the respiratory compensation point (RCP). For the control group, no interval training was conducted. A two-factor ANOVA revealed significant increases on performance measures obtained from a laboratory-graded exercise test (GXT) (P (max): 2.8 ± 3.0%; p < 0.01; PO and [Formula: see text] at RCP: 3.6 ± 6.3% and 4.7 ± 8.2%, respectively; p < 0.05; and [Formula: see text] at ventilatory threshold: 4.9 ± 5.6%; p < 0.01), with no significant group effects. Significant interactions between group and uphill and flat time-trial, pre- versus post-training on PO were observed (p < 0.05). Int(60) increased PO during both TT(up) (4.4 ± 5.3%) and TT(flat) (1.5 ± 4.5%). The changes were -1.3 ± 3.6, 2.6 ± 6.0% for Int(100) and 4.0 ± 4.6%, -3.5 ± 5.4% for Con during TT(up) and TT(flat), respectively. PO was significantly higher during TT(up) than TT(flat) (4.4 ± 6.0; 6.3 ± 5.6%; pre and post-training, respectively; p < 0.001). These findings suggest that higher forces during the low-cadence intervals are potentially beneficial to improve performance. In contrast to the GXT, the time-trials are ecologically valid to detect specific performance adaptations.

  3. Effects of 10min vs. 20min passive rest after warm-up on 100m freestyle time-trial performance: A randomized crossover study.

    Science.gov (United States)

    Neiva, Henrique P; Marques, Mário C; Barbosa, Tiago M; Izquierdo, Mikel; Viana, João L; Marinho, Daniel A

    2017-01-01

    The aim of this study was to compare the effect of 10min vs. 20min passive rest post warm-up on performance in a 100m freestyle time-trial. Randomized crossover. Eleven competitive male swimmers performed two experimental trials on different days, consisting of 100m freestyle time-trials following 10min or 20min passive rest after a standard 1200m warm-up. Performance (time-trial), biomechanical (stroke length, stroke frequency, stroke index, propelling efficiency), physiological (blood lactate concentrations, heart rate, core and tympanic temperature), and psychophysiological (perceived effort) variables were assessed during both trials. Time-trial performance was faster after 10min as opposed to 20min passive rest (58.41±1.99s vs. 59.06±1.86, prest (89±12bpm vs. 82±13bpm; prest. These data suggest that the 10min post warm-up passive rest enhances 100m freestyle performance when compared to a 20min period. An improvement that appears to be mediated by the combined effects of a shorter post warm-up period on core temperature, heart rate and oxygen uptake. Copyright © 2016 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  4. Study on flexural performance of preloaded wood beams strengthened with CFRP sheets%预载作用下碳纤维布加固木梁抗弯性能试验

    Institute of Scientific and Technical Information of China (English)

    张莉; 赵尘; 朱少云

    2011-01-01

    Bending experiments on seven rectangular wood beams were performed in this study. The influence of preload level and carbon-fiber-reinforced-polymer ( CFRP) sheet number on the flexural behavior was evaluated. The flexural behavior was examined in terms of failure characteristics, load-deflection relationship, cross-section strain distribution, and ultimate bearing capacity. Hie results indicated that reinforcement with CFRP sheet was an effective technique. The ultimate bearing capacity of wood beams strengthened with one layer of CFRP sheet increased about 6.2% -12.1% and the effect was more obvious with two layers of CFRP sheet. At the same time, the preload level was found to have a noticeable influence on the ultimate bearing capacity of strengthened wood beams.%通过7组矩形木梁抗弯试验,探讨了不同预载程度和碳纤维布层数对加固效果的影响,研究了木梁的破坏特征、荷载-挠度关系、应变分布和极限承载力.试验结果表明,采用碳纤维布提高木梁抗弯承载力的方法是有效的,粘贴1层碳纤维布的木梁极限承载力提高6.2%~12.1%,粘贴2层的效果更加明显,同时我们发现预载程度对木梁极限承载力的影响不容忽视.

  5. Randomized controlled trial: impact of glycerin suppositories on time to full feeds in preterm infants.

    Science.gov (United States)

    Khadr, Sophie N; Ibhanesebhor, Samuel E; Rennix, Connie; Fisher, Hazel E; Manjunatha, Chikkanayakanahalli M; Young, David; Abara, Rosemary C

    2011-01-01

    Feed intolerance delays achievement of enteral feeding in preterm infants. Parenteral nutrition is associated with cholestasis and increased risk of sepsis. Glycerin suppositories have been used to promote gastrointestinal motility and feed tolerance. To investigate whether daily glycerin suppositories (a) reduce the time to full enteral feeding in infants born at suppository for 10 days from 24 h of age, 250 mg (24-27(+6) weeks subgroup) or 500 mg (two 250-mg suppositories; 28-31(+6) weeks subgroup); controls - no intervention. The same feeding protocol and departmental guidelines for other aspects of neonatal intensive care were used in all subjects. Analysis was by intention to treat. 54 babies were recruited (31 males), 29 randomized to receive suppositories; 48 achieved full enteral feeds. The median (range) time to full feeds was 1.6 days shorter in intervention group babies than controls, but not statistically significant: 7.4 (4.6-30.9) days versus 9.0 (4.4-13.3) days (p = 0.780; 95% confidence interval: -1.917, 2.166). No significant differences were observed in secondary outcomes. Intervention group babies passed their first stool earlier than controls (median: day 2 vs. day 4; p = 0.016). Regular glycerin suppositories did not reduce the time to full enteral feeds in infants born at <32 weeks' gestation in our setting. Copyright © 2011 S. Karger AG, Basel.

  6. Evaluation of the First Stool Pass Time Induced by Marketed Sorbitol in Benzodiazepine Intoxicated Patients: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Farzad Gheshlaghi

    2012-01-01

    Full Text Available Background: Poisoning, a common worldwide problem, seeks its own treatments toimprove, especially by the forthcoming evidence based medicine (EBM.Charcoal/sorbitol slurry (CSS administration is one of these methods with greatdebates around it which needs to be investigated more.Methods: In this clinical trial, 105 cases of benzodiazepine toxicity with at least 3symptoms and no contraindication for sorbitol prescription were divided into 3 groups.Patient grouping was based on the sorbitol manufacturing factory. Sorbitol wasprescribed for the patients, with one kind of sorbitol for the patients of each group. Themeasured variable was the time passed up to the presence of charcoal-mixed stool andthe gathered data were analyzed by ANOVA test using SPSS software.Results: The average age was 25.8±8.4 in females and 24±8.5 years for males(P=0.641. The average follow up time was 8.3±3.1 hours for females and 8.1±2.7hours for males (P=0.30. The average pass time from drug ingestion, was 46±23.15min in females and 40±23.15 min in males (P=0.132. Interestingly, no sorbitol was ableto increase in transit time in the study population despite a follow-up interval about 3times more than expected (based on the reference.Conclusion: No increase in transit time was seen by sorbitol prescription in our casesdespite the appropriate follow-up interval. This ineffectiveness may be somehow due tothe absence of standard sorbitol amounts in those products, but we assume that it ismainly due to the population-based bowel habits (i.e. constipated ones with essentialprolonged transit time.

  7. Evaluation of time, attendance of medical staff, and resources during interstitial brachytherapy for prostate cancer. DEGRO-QUIRO trial

    Energy Technology Data Exchange (ETDEWEB)

    Tselis, N.; Zamboglou, N. [Sana Klinikum Offenbach, Department of Radiation Oncology, Offenbach am Main (Germany); Maurer, U. [St.-Antonius-Hospital, Strahlentherapie, Eschweiler (Germany); Popp, W. [Prime Networks AG, Basel (Switzerland); Sack, H. [University of Essen, Department of Radiation Oncology, Essen (Germany)

    2014-04-15

    The German Society of Radiation Oncology initiated a multicenter trial to evaluate core processes and subprocesses of radiotherapy by prospective evaluation of all important procedures in the most frequent malignancies treated by radiation therapy. The aim of this analysis was to assess the required resources for interstitial high-dose-rate (HDR) and low-dose-rate (LDR) prostate brachytherapy (BRT) based on actual time measurements regarding allocation of personnel and room occupation needed for specific procedures. Two radiotherapy centers (community hospital of Offenbach am Main and community hospital of Eschweiler) participated in this prospective study. Working time of the different occupational groups and room occupancies for the workflow of prostate BRT were recorded and methodically assessed during a 3-month period. For HDR and LDR BRT, a total of 560 and 92 measurements, respectively, were documented. The time needed for treatment preplanning was median 24 min for HDR (n=112 measurements) and 6 min for LDR BRT (n=21). Catheter implantation with intraoperative HDR real-time planning (n=112), postimplantation HDR treatment planning (n=112), and remotely controlled HDR afterloading irradiation (n=112) required median 25, 39, and 50 min, respectively. For LDR real-time planning (n=39) and LDR treatment postplanning (n=32), the assessed median duration was 91 and 11 min, respectively. Room occupancy and overall mean medical staff times were 194 and 910 min respectively, for HDR, and 113 and 371 min, respectively, for LDR BRT. In this prospective analysis, the resource requirements for the application of HDR and LDR BRT of prostate cancer were assessed methodically and are presented for first time. (orig.)

  8. Positive pacing strategies are utilised by elite male and female para-cyclists in short time trials in the velodrome

    Directory of Open Access Journals (Sweden)

    Rachel Lindsey Wright

    2016-01-01

    Full Text Available In para-cycling, competitors are classed based on functional impairment resulting in cyclists with neurological and locomotor impairments competing against each other. In Paralympic competition, classes are combined by using a factoring adjustment to race times to produce the overall medallists. Pacing in short-duration track cycling events is proposed to utilise an all-out strategy in able-bodied competition. However, pacing in para-cycling may vary depending on the level of impairment. Analysis of the pacing strategies employed by different classification groups may offer scope for optimal performance; therefore, this study investigated the pacing strategy adopted during the 1-km time trial (TT and 500-m TT in elite C1 to C3 para-cyclists and able-bodied cyclists. Total times and intermediate split times (125-m intervals; measured to 0.001s were obtained from the C1-C3 men’s 1-km TT (n=28 and women’s 500-m TT (n=9 from the 2012 Paralympic Games and the men’s 1-km TT (n=19 and women’s 500-m TT (n=12 from the 2013 UCI World Track Championships from publically available video. Split times were expressed as actual time, factored time (for the para-cyclists and as a percentage of total time. A two-way analysis of variance was used to investigate differences in split times between the different classifications and the able-bodied cyclists in the men’s 1-km TT and between the para-cyclists and able-bodied cyclists in the women’s 500-m TT. The importance of position at the first split was investigated with Kendall’s Tau-b correlation. The first 125-m split time was the slowest for all cyclists, representing the acceleration phase from a standing start. C2 cyclists were slowest at this 125-m split, probably due to a combination of remaining seated in this acceleration phase and a high proportion of cyclists in this group being trans-femoral amputees. Not all cyclists used aero-bars, preferring to use drop, flat or bullhorn handlebars

  9. Positive Pacing Strategies Are Utilized by Elite Male and Female Para-cyclists in Short Time Trials in the Velodrome

    Science.gov (United States)

    Wright, Rachel L.

    2016-01-01

    In para-cycling, competitors are classed based on functional impairment resulting in cyclists with neurological and locomotor impairments competing against each other. In Paralympic competition, classes are combined by using a factoring adjustment to race times to produce the overall medallists. Pacing in short-duration track cycling events is proposed to utilize an “all-out” strategy in able-bodied competition. However, pacing in para-cycling may vary depending on the level of impairment. Analysis of the pacing strategies employed by different classification groups may offer scope for optimal performance; therefore, this study investigated the pacing strategy adopted during the 1-km time trial (TT) and 500-m TT in elite C1 to C3 para-cyclists and able-bodied cyclists. Total times and intermediate split times (125-m intervals; measured to 0.001 s) were obtained from the C1-C3 men's 1-km TT (n = 28) and women's 500-m TT (n = 9) from the 2012 Paralympic Games and the men's 1-km TT (n = 19) and women's 500-m TT (n = 12) from the 2013 UCI World Track Championships from publically available video. Split times were expressed as actual time, factored time (for the para-cyclists) and as a percentage of total time. A two-way analysis of variance was used to investigate differences in split times between the different classifications and the able-bodied cyclists in the men's 1-km TT and between the para-cyclists and able-bodied cyclists in the women's 500-m TT. The importance of position at the first split was investigated with Kendall's Tau-b correlation. The first 125-m split time was the slowest for all cyclists, representing the acceleration phase from a standing start. C2 cyclists were slowest at this 125-m split, probably due to a combination of remaining seated in this acceleration phase and a high proportion of cyclists in this group being trans-femoral amputees. Not all cyclists used aero-bars, preferring to use drop, flat or bullhorn handlebars. Split times

  10. Stress and Fatigue Management Using Balneotherapy in a Short-Time Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Lolita Rapolienė

    2016-01-01

    Full Text Available Objective. To investigate the influence of high-salinity geothermal mineral water on stress and fatigue. Method. 180 seamen were randomized into three groups: geothermal (65, music (50, and control (65. The geothermal group was administered 108 g/L salinity geothermal water bath for 2 weeks five times a week. Primary outcome was effect on stress and fatigue. Secondary outcomes were the effect on cognitive function, mood, and pain. Results. The improvements after balneotherapy were a reduction in the number and intensity of stress-related symptoms, a reduction in pain and general, physical, and mental fatigue, and an improvement in stress-related symptoms management, mood, activation, motivation, and cognitive functions with effect size from 0.8 to 2.3. In the music therapy group, there were significant positive changes in the number of stress symptoms, intensity, mood, pain, and activity with the effect size of 0.4 to 1.1. The researchers did not observe any significant positive changes in the control group. The comparison between the groups showed that balneotherapy was superior to music therapy and no treatment group. Conclusions. Balneotherapy is beneficial for stress and fatigue reduction in comparison with music or no therapy group. Geothermal water baths have a potential as an efficient approach to diminish stress caused by working or living conditions.

  11. When is The Best Time of Stem Cell Transplantation for Treating Acute Myocardial Infarction——A Brief Meta-analysis of Current Clinic Trials

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    The best time of stem cells transplantation for treating acute myocardial infarction (AMI) is still to be followed with interest and a focus issue for clinical cardiologist. A brief meta-analysis of clinical trials about timing-window and therapeutic effects of stem cell transplantation for treating AMI will be made out in this article.

  12. Experiential Virtual Scenarios With Real-Time Monitoring (Interreality) for the Management of Psychological Stress: A Block Randomized Controlled Trial

    Science.gov (United States)

    Pallavicini, Federica; Morganti, Luca; Serino, Silvia; Scaratti, Chiara; Briguglio, Marilena; Crifaci, Giulia; Vetrano, Noemi; Giulintano, Annunziata; Bernava, Giuseppe; Tartarisco, Gennaro; Pioggia, Giovanni; Raspelli, Simona; Cipresso, Pietro; Vigna, Cinzia; Grassi, Alessandra; Baruffi, Margherita; Wiederhold, Brenda; Riva, Giuseppe

    2014-01-01

    Background The recent convergence between technology and medicine is offering innovative methods and tools for behavioral health care. Among these, an emerging approach is the use of virtual reality (VR) within exposure-based protocols for anxiety disorders, and in particular posttraumatic stress disorder. However, no systematically tested VR protocols are available for the management of psychological stress. Objective Our goal was to evaluate the efficacy of a new technological paradigm, Interreality, for the management and prevention of psychological stress. The main feature of Interreality is a twofold link between the virtual and the real world achieved through experiential virtual scenarios (fully controlled by the therapist, used to learn coping skills and improve self-efficacy) with real-time monitoring and support (identifying critical situations and assessing clinical change) using advanced technologies (virtual worlds, wearable biosensors, and smartphones). Methods The study was designed as a block randomized controlled trial involving 121 participants recruited from two different worker populations—teachers and nurses—that are highly exposed to psychological stress. Participants were a sample of teachers recruited in Milan (Block 1: n=61) and a sample of nurses recruited in Messina, Italy (Block 2: n=60). Participants within each block were randomly assigned to the (1) Experimental Group (EG): n=40; B1=20, B2=20, which received a 5-week treatment based on the Interreality paradigm; (2) Control Group (CG): n=42; B1=22, B2=20, which received a 5-week traditional stress management training based on cognitive behavioral therapy (CBT); and (3) the Wait-List group (WL): n=39, B1=19, B2=20, which was reassessed and compared with the two other groups 5 weeks after the initial evaluation. Results Although both treatments were able to significantly reduce perceived stress better than WL, only EG participants reported a significant reduction (EG=12% vs CG=0

  13. Shortening Infusion Time for High-Dose Methotrexate Alters Antileukemic Effects: A Randomized Prospective Clinical Trial

    Science.gov (United States)

    Mikkelsen, Torben S.; Sparreboom, Alex; Cheng, Cheng; Zhou, Yinmei; Boyett, James M.; Raimondi, Susana C.; Panetta, John C.; Bowman, W. Paul; Sandlund, John T.; Pui, Ching-Hon; Relling, Mary V.; Evans, William E.

    2011-01-01

    Purpose To determine whether shortening the infusion duration of high-dose methotrexate (HDMTX; 1 g/m2) affects the in vivo accumulation of active methotrexate polyglutamates (MTXPG1-7) in leukemia cells and whether this differs among major acute lymphoblastic leukemia (ALL) subtypes. Methods From June 2000 through October 2007, 356 children with ALL were randomly assigned to receive initial single-agent treatment with HDMTX (1 g/m2) as either a 24-hour infusion or a 4-hour infusion at two pediatric hospitals in the United States. The primary outcome measures were the accumulation of MTXPG1-7 in leukemia cells and the antileukemic effects (eg, inhibition of de novo purine synthesis in bone marrow ALL cells, and decrease in circulating ALL cells). Results The 24-hour infusion resulted in significantly higher amounts of MTXPG1-7 in bone marrow leukemia cells (median: 1,695 v 1,150 pmol/109 cells, P = .0059), and better antileukemic effects. The 24-hour infusion had the greatest effect on MTXPG1-7 accumulation in hyperdiploid ALL (median: 3,919 v 2,417 pmol/109 cells, P = .0038); T-cell ALL exhibited smaller differences in MTXPG1-7 but greater antileukemic effects with the longer infusion (median decrease in leukemia cells: 88.4% v 51.8%, P = .0075). In contrast, infusion duration had no significant impact on MTXPG1-7 accumulation or antileukemic effects in ALL with the t(12;21)/(ETV6-RUNX1) chromosomal translocation. Conclusion Shortening the infusion time of HDMTX reduces accumulation of active methotrexate in leukemia cells and decreases antileukemic effects, with differing consequences among major ALL subtypes. PMID:21444869

  14. Effects of Depot Medroxyprogesterone Acetate Injection Timing on Medical Abortion Efficacy and Repeat Pregnancy: A Randomized Controlled Trial.

    Science.gov (United States)

    Raymond, Elizabeth G; Weaver, Mark A; Louie, Karmen S; Tan, Yi-Ling; Bousiéguez, Manuel; Aranguré-Peraza, Ana Gabriela; Lugo-Hernández, Elba M; Sanhueza, Patricio; Goldberg, Alisa B; Culwell, Kelly R; Kaplan, Clair; Memmel, Lisa; Sonalkar, Sarita; Jamshidi, Roxanne; Winikoff, Beverly

    2016-10-01

    To evaluate the effects of timing of depot medroxyprogesterone acetate injection on medical abortion outcome and risk of repeat pregnancy within the subsequent 6 months. In a multinational randomized trial, we assigned women undergoing medical abortion who wanted depot medroxyprogesterone acetate to administration either with mifepristone (Quickstart group) or after the abortion (Afterstart group). We ascertained abortion outcome, pregnancies, and contraception use over 7 months. From August 2013 to March 2015, we enrolled 461 participants with pregnancy durations of 75 days or less. Of participants included in the abortion outcome analyses, 14 of 220 (6.4%) and 12 of 226 (5.3%) in the Quickstart and Afterstart groups, respectively, had surgery to complete the abortion; the upper 90% confidence limit on this difference was 4.9%, within our prestipulated 5% noninferiority margin. Ongoing pregnancy after initial abortion treatment was significantly more common in the Quickstart group (8/220 [3.6%]) than in the Afterstart group (2/226 [0.9%]); the difference was 2.7% (90% confidence interval 0.4-5.6%). By 6 months, 5 of 213 (2.3%) and 7 of 217 (3.2%) in the Quickstart and Afterstart groups, respectively, became pregnant (exact log-rank test, P=.64). Use of highly effective contraceptives was significantly more common in the Quickstart group at 31 days (P<.001), but no difference was apparent at 6 months. The Quickstart group was significantly more satisfied with group assignment. Depot medroxyprogesterone acetate administration with mifepristone did not appreciably increase the risk of surgery after medical abortion but did increase the risk of ongoing pregnancy. It enhanced patient satisfaction, but we found no evidence that it decreased 6-month risk of repeat pregnancy. ClinicalTrials.gov, https://clinicaltrials.gov, NCT01902485.

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

    Science.gov (United States)

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

    2011-12-01

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

  16. Cross-sectional study of Pfizer-sponsored clinical trials: assessment of time to publication and publication history

    OpenAIRE

    Mooney, LaVerne A; Fay, Lorna

    2016-01-01

    Objective To estimate the proportion of Pfizer-sponsored clinical trials that completed in 2010 and are published as manuscripts in the peer-reviewed literature, and to assess the manuscript development history. Design Retrospective, cross-sectional analysis. Setting Clinical trials registered in ClinicalTrials.gov that completed in 2010 for approved, Pfizer prescription products in patients or vaccines in healthy participants. Main outcome measures The proportion of studies for which the pri...

  17. Prevention of altered hemodynamics after spinal anesthesia: A comparison of volume preloading with tetrastarch, succinylated gelatin and ringer lactate solution for the patients undergoing lower segment caesarean section

    Directory of Open Access Journals (Sweden)

    Tapobrata Mitra

    2014-01-01

    Full Text Available Background: Spinal anesthesia has replaced general anesthesia in obstetric practice. Hemodynamic instability is a common, but preventable complication of spinal anesthesia. Preloading the circulation with intravenous fluids is considered a safe and effective method of preventing hypotension following spinal anesthesia. We had conducted a study to compare the hemodynamic stability after volume preloading with either Ringer′s lactate (RL or tetrastarch hydroxyethyl starch (HES or succinylated gelatin (SG in the patients undergoing cesarean section under spinal anesthesia. Materials and Methods: It was a prospective, double-blinded and randomized controlled study. Ninety six ASA-I healthy, nonlaboring parturients were randomly divided in 3 groups HES, SG, RL (n = 32 each and received 10 ml/kg HES 130/0.4; 10 ml/kg SG (4% modified fluid gelatin and 20 ml/kg RL respectively prior to SA scheduled for cesarean section. Heart rate, blood pressure (BP, oxygen saturation was measured. Results: The fall in systolic blood pressure (SBP (<100 mm Hg noted among 5 (15.63%, 12 (37.5% and 14 (43.75% parturients in groups HES, SG, RL respectively. Vasopressor (phenylephrine was used to treat hypotension when SBP <90 mm Hg. Both the results and APGAR scores were comparable in all the groups. Lower preloading volume and less intra-operative vasopressor requirement was noted in HES group for maintaining BP though it has no clinical significance. Conclusion: RL which is cheap, physiological and widely available crystalloid can preload effectively and maintain hemodynamic stability well in cesarean section and any remnant hypotension can easily be manageable with vasopressor.

  18. Shot peening under preloading conditions. Influence on residual stress state and fatigue of components. Festigkeitsstrahlen unter Vorspannung. Auswirkung auf Eigenspannungszustand und Schwingfestigkeit von Bauteilen

    Energy Technology Data Exchange (ETDEWEB)

    Engelmohr, F. (BMW AG, Muenchen (Germany). Hauptabteilung Betriebsfestigkeit); Fiedler, B. (BMW AG, Muenchen (Germany). Hauptabteilung Betriebsfestigkeit)

    1994-10-01

    Lightweight construction of vehicles supports saving of energy. The service life and fatigue strength of certain car components can be improved by shot peening under preloading conditions. Simultaneously the scattering may be reduced. This enables to reduce the weight of those components. This paper deals with the reasons for increasing the fatigue strength and decreasing of its scattering as well as the influence of parameters on these properties for the examples of piston rods and barrel springs. (orig.)

  19. Survival times of women with metastatic breast cancer starting first-line chemotherapy in routine clinical practice versus contemporary randomised trials.

    Science.gov (United States)

    Thientosapol, E S; Tran, T T; Della-Fiorentina, S A; Adams, D H; Chantrill, L; Stockler, M R; Kiely, B E

    2013-08-01

    Survival times of women starting first-line chemotherapy for metastatic breast cancer (MBC) in routine clinical practice were determined and compared with those from a systematic review of randomised clinical trials. We identified women with MBC starting first-line chemotherapy from June 2003 to February 2011 and recorded their demographics, tumour and treatment characteristics, and survival times from the start of chemotherapy. Their survival distribution was summarised by the following percentiles (represented scenarios for survival): 90th (worst-case), 75th (lower-typical), 25th (upper-typical) and 10th (best-case), which were compared with the same percentiles from our systematic review of first-line chemotherapy trials. The 273 women had a median age of 56 years, and a median time from diagnosis of MBC of 3 months. Eastern Cooperative Oncology Group performance status was 0-1 in 80%. Tumours were hormone receptor positive in 69%, human epidermal growth factor receptor 2 (HER2)-positive in 27% and triple negative in 13%. Survival times in months in routine clinical practice (vs the systematic review) were: 90th percentile 4 (6); 75th percentile 9 (12); median 20 (22); 25th percentile 36 (36) and 10th percentile 61 (56). Independent predictors of overall survival included HER2-positive disease (hazard ratio (HR) 0.49, P = 0.0002), hormone receptor positive disease (HR 0.51, P = 0.0004), Eastern Cooperative Oncology Group performance status 0-1 (HR 0.36, P HR 1.86, P = 0.0002). Median and better survival times in routine practice were similar to those from randomised clinical trials; however, survival times worse than the median were shorter, likely reflecting patient selection in trials. Oncologists should adjust trial-based survival estimates for patients not meeting typical trial eligibility criteria. © 2013 The Authors; Internal Medicine Journal © 2013 Royal Australasian College of Physicians.

  20. Metabolic consequences of β-alanine supplementation during exhaustive supramaximal cycling and 4000-m time-trial performance.

    Science.gov (United States)

    Bellinger, Phillip M; Minahan, Clare L

    2016-08-01

    The present study investigated the effects of β-alanine supplementation on the resultant blood acidosis, lactate accumulation, and energy provision during supramaximal-intensity cycling, as well as the aerobic and anaerobic contribution to power output during a 4000-m cycling time trial (TT). Seventeen trained cyclists (maximal oxygen uptake = 4.47 ± 0.55 L·min(-1)) were administered 6.4 g of β-alanine (n = 9) or placebo (n = 8) daily for 4 weeks. Participants performed a supramaximal cycling test to exhaustion (equivalent to 120% maximal oxygen uptake) before (PreExh) and after (PostExh) the 4-week supplementation period, as well as an additional postsupplementation supramaximal cycling test identical in duration and power output to PreExh (PostMatch). Anaerobic capacity was quantified and blood pH, lactate, and bicarbonate concentrations were measured pre-, immediately post-, and 5 min postexercise. Subjects also performed a 4000-m cycling TT before and after supplementation while the aerobic and anaerobic contributions to power output were quantified. β-Alanine supplementation increased time to exhaustion (+12.8 ± 8.2 s; P = 0.041) and anaerobic capacity (+1.1 ± 0.7 kJ; P = 0.048) in PostExh compared with PreExh. Performance time in the 4000-m TT was reduced following β-alanine supplementation (-6.3 ± 4.6 s; P = 0.034) and the mean anaerobic power output was likely to be greater (+6.2 ± 4.5 W; P = 0.035). β-Alanine supplementation increased time to exhaustion concomitant with an augmented anaerobic capacity during supramaximal intensity cycling, which was also mirrored by a meaningful increase in the anaerobic contribution to power output during a 4000-m cycling TT, resulting in an enhanced overall performance.

  1. An online spaced-education game among clinicians improves their patients' time to blood pressure control: a randomized controlled trial.

    Science.gov (United States)

    Kerfoot, B Price; Turchin, Alexander; Breydo, Eugene; Gagnon, David; Conlin, Paul R

    2014-05-01

    Many patients with high blood pressure (BP) do not have antihypertensive medications appropriately intensified at clinician visits. We investigated whether an online spaced-education (SE) game among primary care clinicians can decrease time to BP target among their hypertensive patients. A 2-arm randomized trial was conducted over 52 weeks among primary care clinicians at 8 hospitals. Educational content consisted of 32 validated multiple-choice questions with explanations on hypertension management. Providers were randomized into 2 groups: SE clinicians were enrolled in the game, whereas control clinicians received identical educational content in an online posting. SE game clinicians were e-mailed 1 question every 3 days. Adaptive game mechanics resent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition. Primary outcome measure was time to BP target (game was completed by 87% of clinicians (48/55), whereas 84% of control clinicians (47/56) read the online posting. In multivariable analysis of 17 866 hypertensive periods among 14 336 patients, the hazard ratio for time to BP target in the SE game cohort was 1.043 (95% confidence interval, 1.007-1.081; P=0.018). The number of hypertensive episodes needed to treat to normalize one additional patient's BP was 67.8. The number of clinicians needed to teach to achieve this was 0.43. An online SE game among clinicians generated a modest but significant reduction in the time to BP target among their hypertensive patients. http://www.clinicaltrials.gov. Unique identifier: NCT00904007. © 2014 American Heart Association, Inc.

  2. Comparison of survival time and comfort between 2 clear overlay retainers with different thicknesses: A pilot randomized controlled trial.

    Science.gov (United States)

    Zhu, Yafen; Lin, Jianchang; Long, Hu; Ye, Niansong; Huang, Renhuan; Yang, Xin; Jian, Fan; Lai, Wenli

    2017-03-01

    The objective of this 2-arm parallel trial was to compare the survival times, failure rates, and comfort of 2 clear overlay retainers with different thicknesses (0.75 and 1.00 mm). Eighty eligible participants who had undergone orthodontic treatment at West China Stomatology Hospital of Sichuan University were recruited and randomly assigned to either the 0.75-mm group or the 1.00-mm group. Eligibility criteria included patients with central incisors, canines, and first molars and no systemic or oral disease. The main outcomes were survival time and total failure rate; the secondary outcomes were rates of different types of failure (fracture, loss, nonfitting, and abrasion); tertiary outcomes included patients' comfort levels assessed with a visual analog scale and a health survey. Randomization was accomplished by tossing a coin, with the allocations concealed in sequentially numbered, opaque, sealed envelopes, and blinding implemented among practitioners, patients, and analysts. Patients were evaluated at 1, 3, 6, and 12 months of follow-up. A total of 80 patients were initially recruited and randomized (42 in the 0.75-mm group, 38 in the 1.00-mm group); 72 patients completed the study and were analyzed (37 in the 0.75-mm group, 35 in the 1.00-mm group); there were 8 dropouts. Baseline characteristics were similar between the groups. At the end of the 1-year follow-up, survival time did not differ significantly between the groups (46.5 days; 95% confidence interval [CI], -10.3 -103.2; P = 0.111). The hazard ratio was 0.77 (95% CI, 0.48-1.24; P = 0.281). With regard to total failure rate, no statistical difference (P = 0.118) existed between the 0.75-mm group (43.2%) and the 1.00-mm group (25.7%) (risk difference, 17.5%; 95% CI, -4.0%-39.1%). Among the different failure types, we found that fracture rates were significantly higher in the 0.75-mm group than in the 1.00-mm group (P = 0.028), whereas other failure types were similar between the groups

  3. In vivo release by vagal stimulation of L-/sup 3/Hglutamic acid in the nucleus tractus solitarius preloaded with L-/sup 3/Hglutamine

    Energy Technology Data Exchange (ETDEWEB)

    Granata, A.R.; Sved, A.F.; Reis, D.J.

    1984-01-01

    In anesthetized and paralyzed rats, using a push-pull perfusion technique, we examined the effect of bilateral vagal stimulation on the release of L-/sup 3/Hglutamic acid (L-/sup 3/HGlu) from the nucleus tractus solitarius (NTS), after preloading the tissue either with L-/sup 3/HGlu or L-/sup 3/Hglutamine (L-/sup 3/HGln). Vagal stimulation sufficient to produce a maximum fall of arterial pressure (AP) evoked release of L-/sup 3/HGlu from the NTS when the tissue was preloaded with either /sup 3/H-Glu or /sup 3/H-Gln, and of D-/sup 3/Haspartic acid (D-/sup 3/HAsp) when this stable Glu analogue was used to preloaded with either /sup 3/H-Glu or /sup 3/H-Gln, and of D-/sup 3/H precursor L-Gln is a good marker of the releasable pool of L-Glu in vivo and are consistent with the hypothesis that L-/sup 3/HGlu is a neurotransmitter in the NTS, mediating the vasodepressor response from cardiopulmonary mechanoreceptors.

  4. Decoding a bistable percept with integrated time-frequency representation of single-trial local field potential

    Science.gov (United States)

    Wang, Zhisong; Logothetis, Nikos K.; Liang, Hualou

    2008-12-01

    Bistable perception emerges when a stimulus under continuous view is perceived as the alternation of two mutually exclusive states. Such a stimulus provides a unique opportunity for understanding the neural basis of visual perception because it dissociates the perception from the visual input. In this paper we analyze the dynamic activity of local field potential (LFP), simultaneously collected from multiple channels in the middle temporal (MT) visual cortex of a macaque monkey, for decoding its bistable structure-from-motion (SFM) perception. Based on the observation that the discriminative information of neuronal population activity evolves and accumulates over time, we propose to select features from the integrated time-frequency representation of LFP using a relaxation (RELAX) algorithm and a sequential forward selection (SFS) algorithm with maximizing the Mahalanobis distance as the criterion function. The integrated-spectrogram based feature selection is much more robust and can achieve significantly better features than the instantaneous-spectrogram based feature selection. We exploit the support vector machines (SVM) classifier and the linear discriminant analysis (LDA) classifier based on the selected features to decode the reported perception on a single trial basis. Our results demonstrate the excellent performance of the integrated-spectrogram based feature selection and suggest that the features in the gamma frequency band (30-100 Hz) of LFP within specific temporal windows carry the most discriminative information for decoding bistable perception. The proposed integrated-spectrogram based feature selection approach may have potential for a myriad of applications involving multivariable time series such as brain-computer interfaces (BCI).

  5. Are reports of randomized controlled trials improving over time? A systematic review of 284 articles published in high-impact general and specialized medical journals.

    Science.gov (United States)

    To, Matthew J; Jones, Jennifer; Emara, Mohamed; Jadad, Alejandro R

    2013-01-01

    Inadequate reporting undermines findings of randomized controlled trials (RCTs). This study assessed and compared articles published in high-impact general medical and specialized journals. Reports of RCTs published in high-impact general and specialized medical journals were identified through a search of MEDLINE from January to March of 1995, 2000, 2005, and 2010. Articles that provided original data on adult patients diagnosed with chronic conditions were included in the study. Data on trial characteristics, reporting of allocation concealment, quality score, and the presence of a trial flow diagram were extracted independently by two reviewers, and discrepancies were resolved by consensus or independent adjudication. Descriptive statistics were used for quantitative variables. Comparisons between general medical and specialized journals, and trends over time were performed using Chi-square tests. Reports of 284 trials were analyzed. There was a significantly higher proportion of RCTs published with adequate reporting of allocation concealment (p = 0.003), presentation of a trial flow diagram (pjournals had higher quality scores than those in specialized journals (p = 0.001), reported adequate allocation concealment more often (p = 0.013), and presented a trial flow diagram more often (pjournals over the last fifteen years. These improvements are likely attributed to concerted international efforts to improve reporting quality such as CONSORT. There is still much room for improvement, especially among specialized journals.

  6. Preliminary clinical trial in percutaneous nephrolithotomy using a real-time navigation system for percutaneous kidney access

    Science.gov (United States)

    Rodrigues, Pedro L.; Moreira, António H. J.; Rodrigues, Nuno F.; Pinho, A. C. M.; Fonseca, Jaime C.; Lima, Estevão.; Vilaça, João. L.

    2014-03-01

    Background: Precise needle puncture of renal calyces is a challenging and essential step for successful percutaneous nephrolithotomy. This work tests and evaluates, through a clinical trial, a real-time navigation system to plan and guide percutaneous kidney puncture. Methods: A novel system, entitled i3DPuncture, was developed to aid surgeons in establishing the desired puncture site and the best virtual puncture trajectory, by gathering and processing data from a tracked needle with optical passive markers. In order to navigate and superimpose the needle to a preoperative volume, the patient, 3D image data and tracker system were previously registered intraoperatively using seven points that were strategically chosen based on rigid bone structures and nearby kidney area. In addition, relevant anatomical structures for surgical navigation were automatically segmented using a multi-organ segmentation algorithm that clusters volumes based on statistical properties and minimum description length criterion. For each cluster, a rendering transfer function enhanced the visualization of different organs and surrounding tissues. Results: One puncture attempt was sufficient to achieve a successful kidney puncture. The puncture took 265 seconds, and 32 seconds were necessary to plan the puncture trajectory. The virtual puncture path was followed correctively until the needle tip reached the desired kidney calyceal. Conclusions: This new solution provided spatial information regarding the needle inside the body and the possibility to visualize surrounding organs. It may offer a promising and innovative solution for percutaneous punctures.

  7. A randomized, controlled trial of meditation for work stress, anxiety and depressed mood in full-time workers.

    Science.gov (United States)

    Manocha, R; Black, D; Sarris, J; Stough, C

    2011-01-01

    Objective. To assess the effect of meditation on work stress, anxiety and mood in full-time workers. Methods. 178 adult workers participated in an 8-week, 3-arm randomized controlled trial comparing a "mental silence" approach to meditation (n = 59) to a "relaxation" active control (n = 56) and a wait-list control (n = 63). Participants were assessed before and after using Psychological Strain Questionnaire (PSQ), a subscale of the larger Occupational Stress Inventory (OSI), the State component of the State/Trait Anxiety Inventory for Adults (STAI), and the depression-dejection (DD) subscale of the Profile of Mood States (POMS). Results. There was a significant improvement for the meditation group compared to both the relaxation control and the wait-list groups the PSQ (P = .026), and DD (P = .019). Conclusions. Mental silence-orientated meditation, in this case Sahaja Yoga meditation, is a safe and effective strategy for dealing with work stress and depressive feelings. The findings suggest that "thought reduction" or "mental silence" may have specific effects relevant to work stress and hence occupational health.

  8. Computed tomography to estimate cardiac preload and extravascular lung water. A retrospective analysis in critically ill patients

    Directory of Open Access Journals (Sweden)

    Schmid Roland M

    2011-05-01

    Full Text Available Abstract Background In critically ill patients intravascular volume status and pulmonary edema need to be quantified as soon as possible. Many critically ill patients undergo a computed tomography (CT-scan of the thorax after admission to the intensive care unit (ICU. This study investigates whether CT-based estimation of cardiac preload and pulmonary hydration can accurately assess volume status and can contribute to an early estimation of hemodynamics. Methods Thirty medical ICU patients. Global end-diastolic volume index (GEDVI and extravascular lung water index (EVLWI were assessed using transpulmonary thermodilution (TPTD serving as reference method (with established GEDVI/EVLWI normal values. Central venous pressure (CVP was determined. CT-based estimation of GEDVI/EVLWI/CVP by two different radiologists (R1, R2 without analyzing software. Primary endpoint: predictive capabilities of CT-based estimation of GEDVI/EVLWI/CVP compared to TPTD and measured CVP. Secondary endpoint: interobserver correlation and agreement between R1 and R2. Results Accuracy of CT-estimation of GEDVI ( 800 mL/m2 was 33%(R1/27%(R2. For R1 and R2 sensitivity for diagnosis of low GEDVI (2 was 0% (specificity 100%. Sensitivity for prediction of elevated GEDVI (> 800 mL/m2 was 86%(R1/57%(R2 with a specificity of 57%(R1/39%(R2 (positive predictive value 38%(R1/22%(R2; negative predictive value 93%(R1/75%(R2. Estimated CT-GEDVI and TPTD-GEDVI were significantly different showing an overestimation of GEDVI by the radiologists (R1: mean difference ± standard error (SE: 191 ± 30 mL/m2, p 2, p 10 mL/kg was 30% for R1 and 40% for R2. CT-EVLWI and TPTD-EVLWI were significantly different (R1: mean difference ± SE: 3.3 ± 1.2 mL/kg, p = 0.013; R2: mean difference ± SE: 2.8 ± 1.1 mL/kg, p = 0.021. Again ccc was low with -0.02 (R1; 95% CI: -0.20 to +0.13, BCF = 0.44 and +0.14 (R2; 95% CI: -0.05 to +0.32, BCF = 0.53. GEDVI, EVLWI and CVP estimations of R1 and R2 showed a poor

  9. Comparative study of NMP-preloaded and dip-loaded membranes for guided bone regeneration of rabbit cranial defects.

    Science.gov (United States)

    Karfeld-Sulzer, Lindsay S; Ghayor, Chafik; Siegenthaler, Barbara; Gjoksi, Bebeka; Pohjonen, Timo H; Weber, Franz E

    2017-02-01

    Guided bone regeneration (GBR) has been utilized for several decades for the healing of cranio-maxillofacial bone defects and, particularly in the dental field, by creating space with a barrier membrane to exclude soft tissue and encourage bone growth in the membrane-protected volume. Although the first membranes were non-resorbable, a new generation of GBR membranes aims to biodegrade and provide bioactivity for better overall results. The Inion GTR™ poly(lactide-co-glycolide) (PLGA) membrane is not only resorbable but also bioactive, since it includes N-methylpyrrolidone (NMP), which has been shown to promote bone regeneration. In this study, the effects of loading different amounts of NMP onto the membrane through chemical vapour deposition or dipping have been explored. In vitro release demonstrated that lower levels of NMP led to lower NMP concentrations and slower release, based on total NMP loaded in the membrane. The dipped membrane released almost all of the NMP within 15 min, leading to a high NMP concentration. For the in vivo studies in rabbits, 6 mm calvarial defects were created and left untreated or covered with an ePTFE membrane or PLGA membranes dipped in, or preloaded with, NMP. Evaluation of the bony regeneration revealed that the barrier membranes improved bony healing and that a decrease in NMP content improved the performance. Overall, we have demonstrated the potential of these PLGA membranes with a more favourable NMP release profile and the significance of exploring the effect of NMP on these PLGA membranes with regard to bone ingrowth. Copyright © 2014 John Wiley & Sons, Ltd.

  10. Demographic and HIV-specific characteristics of participants enrolled in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial

    DEFF Research Database (Denmark)

    Sharma, S; Babiker, A G; Emery, S;

    2015-01-01

    OBJECTIVES: The risks and benefits of initiating antiretroviral treatment (ART) at high CD4 cell counts have not been reliably quantified. The Strategic Timing of AntiRetroviral Treatment (START) study is a randomized international clinical trial that compares immediate with deferred initiation...

  11. The One-stop trial: Does electronic referral and booking by the general practitioner (GPs to outpatient day case surgery reduce waiting time and costs? A randomized controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Vonen Barthold

    2008-08-01

    Full Text Available Abstract Background Waiting time and costs from referral to day case outpatient surgery are at an unacceptably high level. The waiting time in Norway averages 240 days for common surgical conditions. Furthermore, in North Norway the population is scattered throughout a large geographic area, making the cost of travel to a specialist examination before surgery considerable. Electronic standardised referrals and booking of day case outpatient surgery by GPs are possible through the National Health Network, which links all health care providers in an electronic network. New ways of using this network might reduce the waiting time and cost of outpatient day case surgery. Materials and Methods In a randomised controlled trial, selected patients (inguinal hernia, gallstone disease and pilonidal sinus referred to the university hospital are either randomised to direct electronic referral and booking for outpatient surgery (one stop, or to the traditional patient pathway where all patients are seen at the outpatient clinic several weeks ahead of surgery. Consultants in gastrointestinal surgery designed standardised referral forms and guidelines. New software has been designed making it possible to implement referral forms, guidelines and patient information in the GP's electronic health record. For "one-stop" referral, GPs must provide mandatory information about the specific condition. Referrals were linked to a booking system, enabling the GPs to book the hospital, day and time for outpatient surgery. The primary endpoints are waiting time and costs. The sample size calculation was based on waiting time. A reduction in waiting time of 60 days (effect size, 25%, is significant, resulting in a sample size of 120 patients in total. Discussion Poor communication between primary and secondary care often results in inefficiencies and unsatisfactory outcomes. We hypothesised that standardised referrals would improve the quality of information, making it

  12. Tumour targeting and radiation dose of radioimmunotherapy with {sup 90}Y-rituximab in CD20+ B-cell lymphoma as predicted by {sup 89}Zr-rituximab immuno-PET: impact of preloading with unlabelled rituximab

    Energy Technology Data Exchange (ETDEWEB)

    Muylle, Kristoff [Vrije Universiteit Brussel, MIMA Research Group, Brussels (Belgium); Universite Libre de Bruxelles, Department of Nuclear Medicine, Jules Bordet Institute, Brussels (Belgium); Flamen, Patrick; Guiot, Thomas; Ghanem, Ghanem; Meuleman, Nathalie; Bourgeois, Pierre; Vanderlinden, Bruno; Vaes, Melanie; Bron, Dominique [Universite Libre de Bruxelles, Jules Bordet Institute, Brussels (Belgium); Vugts, Danielle J.; Dongen, Guus A.M.S. van [VU University Medical Centre, Amsterdam (Netherlands); Everaert, Hendrik [Vrije Universiteit Brussel, UZ Brussel, Brussels (Belgium); Vrije Universiteit Brussel, MIMA Research Group, Brussels (Belgium)

    2015-07-15

    To compare using immuno-PET/CT the distribution of {sup 89}Zr-labelled rituximab without and with a preload of unlabelled rituximab to assess the impact of preloading with unlabelled rituximab on tumour targeting and radiation dose of subsequent radioimmunotherapy with {sup 90}Y-labelled rituximab in CD20+ B-cell lymphoma. Five patients with CD20+ B-cell lymphoma and progressive disease were prospectively enrolled. All patients underwent three study phases: initial dosimetric phase with baseline {sup 89}Zr-rituximab PET/CT imaging without a cold preload, followed 3 weeks later by a second dosimetric phase with administration of a standard preload (250 mg/m{sup 2}) of unlabelled rituximab followed by injection of {sup 89}Zr-rituximab, and a therapeutic phase 1 week later with administration of unlabelled rituximab followed by {sup 90}Y-rituximab. PET/CT imaging and tracer uptake by organs and lesions were assessed. With a cold rituximab preload, the calculated whole-body dose of {sup 90}Y-rituximab was similar (mean 0.87 mSv/MBq, range 0.82-0.99 mSv/MBq) in all patients. Without a preload, an increase in whole-body dose of 59 % and 87 % was noted in two patients with preserved circulating CD20+ B cells. This increase in radiation dose was primarily due to a 12.4-fold to 15-fold higher dose to the spleen without a preload. No significant change in whole-body dose was noted in the three other patients with B-cell depletion. Without a preload, consistently higher tumour uptake was noticed in patients with B-cell depletion. Administration of the standard preload of unlabelled rituximab impairs radioconjugate tumour targeting in the majority of patients eligible for radioimmunotherapy, that is patients previously treated with rituximab-containing therapeutic regimens. This common practice may need to be reconsidered and further evaluated as the rationale for this high preload has its origin in the ''prerituximab era''. (orig.)

  13. Diabetic Macular Edema at the time of Cataract Surgery trial: a prospective, randomized clinical trial of intravitreous bevacizumab versus triamcinolone in patients with diabetic macular oedema at the time of cataract surgery - preliminary 6 month results.

    Science.gov (United States)

    Lim, Lyndell L; Morrison, Julie L; Constantinou, Marios; Rogers, Sophie; Sandhu, Sukhpal S; Wickremasinghe, Sanjeewa S; Kawasaki, Ryo; Al-Qureshi, Salmaan

    2016-05-01

    To compare visual and anatomical outcomes between intravitreous bevacizumab (BVB, Avastin) and triamcinolone (TA, Triesence) when administered at the time of cataract surgery in patients with diabetic macular oedema (DME). Prospective, single-masked, randomized clinical trial at The Royal Victorian Eye and Ear Hospital, Melbourne. Patients with clinically significant cataract and either centre-involving DME or DME treated within the previous 24 months. Participants were randomized 1:1 to receive intravitreous BVB 1.25 mg or TA 4 mg during cataract surgery, and at subsequent review if required over 6 months. Change in central macular thickness (CMT) and best corrected visual acuity at 6 months. Forty-one patients (mean age 66.4 years, 73.2% male) were recruited. Visual acuity and CMT were similar between groups at baseline (P > 0.2).After six months, both groups gained vision (mean +21.4 letters in TA group P < 0.0001, +12.5 letters in BVB, P = 0.002), with no significant difference between groups (P = 0.085). In addition, 60.9% of eyes receiving TA achieved a VA of ≥6/12 compared to 73.3% in the BVB group (P = 0.501). However, only TA was associated with a sustained reduction in CMT (-43.8-µm reduction TA vs. +37.3-µm increase BVB, P = 0.006 over 6 months). Following surgery, additional injections were required in 70.6% of participants in the BVB group, compared to 16.7% in the TA group (P < 0.0001). Three patients in the TA group experienced a rise of IOP over 21 mmHg (12.5%) during the 6-month follow-up; BVB had no cases (P = 0.130). There were no cases of endophthalmitis in either group. When administered at the time of cataract surgery in patients with DME, at 6 months both TA and BVB improve visual acuity; however, only TA results in a sustained reduction in CMT. Further follow-up will determine whether this translates into better long-term visual outcomes in the TA group. © 2016 Royal Australian and New

  14. Rationale and methods for a randomized controlled trial of a movement-to-music video program for decreasing sedentary time among mother-child pairs

    OpenAIRE

    Tuominen, Pipsa; Husu, Pauliina; Raitanen, Jani; Luoto, Riitta M.

    2015-01-01

    Background Measured objectively, under a quarter of adults and fewer than half of preschool children meet the criteria set in the aerobic physical activity recommendations of the Centers for Disease Control and Prevention. Moreover, adults reportedly are sedentary (seated or lying down) for most of their waking hours. Importantly, greater amounts of sedentary time on parents’ part are associated with an increased risk of more sedentary time among their children. A randomized controlled trial ...

  15. Combined Evaluations of Competency to Stand Trial and Mental State at the Time of the Offense: An Overlooked Methodological Consideration?

    Science.gov (United States)

    Kois, Lauren; Wellbeloved-Stone, James M; Chauhan, Preeti; Warren, Janet I

    2017-02-09

    Combined evaluations of competency to stand trial (CST; competency) and mental state at the time of the offense (MSO; sanity) frequently co-occur. However, most research examines the 2 as discrete constructs without considering 4 potential combined evaluation outcomes: competent-sane, incompetent-sane, competent-insane, and incompetent-insane. External validity can be improved if research more closely mirrored practice. It may be incorrect to assume incompetent defendants are similar across CST-only and combined evaluations, and insane defendants are similar across MSO-only and combined evaluations. Using a sample of 2,751 combined evaluations, we examined demographic, clinical, offense, evaluation, and psycholegal characteristics associated with evaluators' combined evaluation opinions. Multinomial regression analyses revealed older defendants were more likely to be opined incompetent-insane. Defendants with psychotic disorders were more often opined insane, regardless of competency status. Affective diagnoses predicted competent-insane opinions. Developmental disorders were closely related to incompetence, regardless of sanity status. Defendants with organic disorders tended to have global psycholegal impairment, in that they were more often opined incompetent-insane, incompetent-sane, or competent-insane, relative to competent-sane. Prior hospitalization predicted competent-insane relative to competent-sane opinions. Defendants not under the influence of a substance during the offense or with no prior convictions were more likely to be opined insane, regardless of competency status. We interpret these findings in light of psycholegal theory and provide recommendations for research and practice. Collectively, results suggest incorporation of combined evaluations into CST and MSO research is an important methodological consideration not to be overlooked. (PsycINFO Database Record

  16. Relationship Between Time in Therapeutic Range and Comparative Treatment Effect of Rivaroxaban and Warfarin: Results From the ROCKET AF Trial

    Science.gov (United States)

    Piccini, Jonathan P.; Hellkamp, Anne S.; Lokhnygina, Yuliya; Patel, Manesh R.; Harrell, Frank E.; Singer, Daniel E.; Becker, Richard C.; Breithardt, Günter; Halperin, Jonathan L.; Hankey, Graeme J.; Berkowitz, Scott D.; Nessel, Christopher C.; Mahaffey, Kenneth W.; Fox, Keith A. A.; Califf, Robert M.

    2014-01-01

    Background Time in therapeutic range (TTR) is a standard quality measure of the use of warfarin. We assessed the relative effects of rivaroxaban versus warfarin at the level of trial center TTR (cTTR) since such analysis preserves randomized comparisons. Methods and Results TTR was calculated using the Rosendaal method, without exclusion of international normalized ratio (INR) values performed during warfarin initiation. Measurements during warfarin interruptions >7 days were excluded. INRs were performed via standardized finger‐stick point‐of‐care devices at least every 4 weeks. The primary efficacy endpoint (stroke or non‐central nervous system embolism) was examined by quartiles of cTTR and by cTTR as a continuous function. Centers with the highest cTTRs by quartile had lower‐risk patients as reflected by lower CHADS2 scores (P<0.0001) and a lower prevalence of prior stroke or transient ischemic attack (P<0.0001). Sites with higher cTTR were predominantly from North America and Western Europe. The treatment effect of rivaroxaban versus warfarin on the primary endpoint was consistent across a wide range of cTTRs (P value for interaction=0.71). The hazard of major and non‐major clinically relevant bleeding increased with cTTR (P for interaction=0.001), however, the estimated reduction by rivaroxaban compared with warfarin in the hazard of intracranial hemorrhage was preserved across a wide range of threshold cTTR values. Conclusions The treatment effect of rivaroxaban compared with warfarin for the prevention of stroke and systemic embolism is consistent regardless of cTTR. PMID:24755148

  17. Optimal timing of an invasive strategy in patients with non-ST-elevation acute coronary syndrome: a meta-analysis of randomised trials.

    Science.gov (United States)

    Jobs, Alexander; Mehta, Shamir R; Montalescot, Gilles; Vicaut, Eric; Van't Hof, Arnoud W J; Badings, Erik A; Neumann, Franz-Josef; Kastrati, Adnan; Sciahbasi, Alessandro; Reuter, Paul-Georges; Lapostolle, Frédéric; Milosevic, Aleksandra; Stankovic, Goran; Milasinovic, Dejan; Vonthein, Reinhard; Desch, Steffen; Thiele, Holger

    2017-08-19

    A routine invasive strategy is recommended for patients with non-ST-elevation acute coronary syndromes (NSTE-ACS). However, optimal timing of invasive strategy is less clearly defined. Individual clinical trials were underpowered to detect a mortality benefit; we therefore did a meta-analysis to assess the effect of timing on mortality. We identified randomised controlled trials comparing an early versus a delayed invasive strategy in patients presenting with NSTE-ACS by searching MEDLINE, Cochrane Central Register of Controlled Trials, and Embase. We included trials that reported all-cause mortality at least 30 days after in-hospital randomisation and for which the trial investigators agreed to collaborate (ie, providing individual patient data or standardised tabulated data). We pooled hazard ratios (HRs) using random-effects models. This meta-analysis is registered at PROSPERO (CRD42015018988). We included eight trials (n=5324 patients) with a median follow-up of 180 days (IQR 180-360). Overall, there was no significant mortality reduction in the early invasive group compared with the delayed invasive group HR 0·81, 95% CI 0·64-1·03; p=0·0879). In pre-specified analyses of high-risk patients, we found lower mortality with an early invasive strategy in patients with elevated cardiac biomarkers at baseline (HR 0·761, 95% CI 0·581-0·996), diabetes (0·67, 0·45-0·99), a GRACE risk score more than 140 (0·70, 0·52-0·95), and aged 75 years older (0·65, 0·46-0·93), although tests for interaction were inconclusive. An early invasive strategy does not reduce mortality compared with a delayed invasive strategy in all patients with NSTE-ACS. However, an early invasive strategy might reduce mortality in high-risk patients. None. Copyright © 2017 Elsevier Ltd. All rights reserved.

  18. Evolution of poor reporting and inadequate methods over time in 20 920 randomised controlled trials included in Cochrane reviews: research on research study.

    Science.gov (United States)

    Dechartres, Agnes; Trinquart, Ludovic; Atal, Ignacio; Moher, David; Dickersin, Kay; Boutron, Isabelle; Perrodeau, Elodie; Altman, Douglas G; Ravaud, Philippe

    2017-06-08

    Objective To examine how poor reporting and inadequate methods for key methodological features in randomised controlled trials (RCTs) have changed over the past three decades.Design Mapping of trials included in Cochrane reviews.Data sources Data from RCTs included in all Cochrane reviews published between March 2011 and September 2014 reporting an evaluation of the Cochrane risk of bias items: sequence generation, allocation concealment, blinding, and incomplete outcome data.Data extraction For each RCT, we extracted consensus on risk of bias made by the review authors and identified the primary reference to extract publication year and journal. We matched journal names with Journal Citation Reports to get 2014 impact factors.Main outcomes measures We considered the proportions of trials rated by review authors at unclear and high risk of bias as surrogates for poor reporting and inadequate methods, respectively.Results We analysed 20 920 RCTs (from 2001 reviews) published in 3136 journals. The proportion of trials with unclear risk of bias was 48.7% for sequence generation and 57.5% for allocation concealment; the proportion of those with high risk of bias was 4.0% and 7.2%, respectively. For blinding and incomplete outcome data, 30.6% and 24.7% of trials were at unclear risk and 33.1% and 17.1% were at high risk, respectively. Higher journal impact factor was associated with a lower proportion of trials at unclear or high risk of bias. The proportion of trials at unclear risk of bias decreased over time, especially for sequence generation, which fell from 69.1% in 1986-1990 to 31.2% in 2011-14 and for allocation concealment (70.1% to 44.6%). After excluding trials at unclear risk of bias, use of inadequate methods also decreased over time: from 14.8% to 4.6% for sequence generation and from 32.7% to 11.6% for allocation concealment.Conclusions Poor reporting and inadequate methods have decreased over time, especially for sequence generation and

  19. Is a short anesthetic exposure in children safe? Time will tell: a focused commentary of the GAS and PANDA trials.

    Science.gov (United States)

    Chinn, Gregory A; Sasaki Russell, Jennifer M; Sall, Jeffrey W

    2016-10-01

    Early life exposure to general anesthesia in preclinical studies has consistently led to permanent cognitive deficits later in life. However, the extent to which this finding is translatable to humans is the subject of much debate as the results from clinical studies have been mixed. Recently two well-designed clinical trials have attempted to add clarity to our murky understanding. The General Anesthesia compared to Spinal anesthesia (GAS) trial, was an international, prospective, randomized, multicenter, equivalence trial comparing infants undergoing herniorrhaphy receiving general anesthesia vs. neuraxial anesthesia. The results released are from a pre-determined secondary outcome of a behavioral/developmental assessment of 2 years old that found equivalence between the two groups. The Pediatric Anesthesia NeuroDevelopment Assessment (PANDA) trial was an ambi-directional cohort trial, comparing patients receiving general anesthesia for hernia repair before 3 years old vs. sibling-matched controls. The neuropsychological battery performed showed no difference between siblings. Taken together, there is cautious optimism that short anesthesia exposure may not lead to significant cognitive decline in humans, but one should also consider that the GAS trial has yet to release the primary endpoint, IQ testing at age 5, and the PANDA trial may not represent the general population given the high socioeconomic status and high control IQ scores. Furthermore, as seen in preclinical studies, the cognitive deficit might not be significant until later in life, and longer exposures to anesthesia may have a more deleterious effect on cognitive function. While these new studies greatly increase our understanding in humans, there are many more questions that need to be addressed.

  20. Research on Reinforcement Depth for Foundation Treatment by Vacuum Preloading%真空预压地基处理的加固深度研究

    Institute of Scientific and Technical Information of China (English)

    吴迪; 孙田

    2011-01-01

    With the development of economy in coastal areas, the requirement of soft-soil treatment is much larger. As vacuum preloading has greater advantage for the soft-soil treatment, so it is widely used. But the research on the influencing depth of the vacuum preloading is little, and there is no definite conclusion. Here, the stressing conditions of soil are analyzed from microcosm and macrocosm based on 3-dimensional consolidation. The difference of vacuum pressure causes much deeper influence. Combined with engineering examples, the conclusion is got that the influencing depth of the vacuum preloading could reach to the end of plastic drainage board by analysing the monitoring data.%随着沿海经济的发展,软土处理的需求加大,真空预压处理软土有着比较大的优势,被广泛运用。但在真空预压的影响深度方面,目前学术界研究的较少,没有给出一个明确的结论。文章从土体三维固结出发,分析土体受力不但在微观上的等向受力,在宏观上受到真空压力差的影响,而且真空压力差增加了真空度的影响深度。同时结合工程实例,分析现场监测数据,得出真空预压影响深度可以达到排水板底部。

  1. 考虑摩擦特性时过盈量对轴承预紧力的影响%Influence of interference on bearing preload considering frictional properties

    Institute of Scientific and Technical Information of China (English)

    宁峰平; 姚建涛; 安静涛; 孙锟; 赵永生

    2015-01-01

    针对航天机构中轴承轴向预紧力精确确定的问题,基于静力学和弹性力学,在考虑配合尺寸、摩擦特性的基础上,研究了轴承预紧力与拧紧力矩的关系.利用锁紧螺母拧紧力矩与轴向力的关系,确定施加于轴承上的轴向力;根据摩擦力与摩擦特性及装配尺寸的关系,分析摩擦力对轴向力的截留作用;通过轴承力平衡方程组,对实际预紧力进行理论分析.文中研究了配合尺寸及摩擦特性对预紧力的影响,揭示了不同装配下预紧力随拧紧力矩的变化规律.研究结果表明:对轴承71807C预紧力结果进行分析,发现相同拧紧力矩下,过盈量增0.5μm,轴向力中约有123 N的力被截留;且摩擦系数增加0.05,轴向力截留率增大约13%.过盈量越大,轴承与主轴间摩擦力对轴向力的截留作用越大,预紧力对应的拧紧力矩越大;相比加热炉加热,油槽加热降低了配合区域的摩擦系数,加载相同的拧紧力矩时使轴承预紧力较大.经试验验证,该理论分析可以确定施加的预紧力,又可以提高装配质量.该研究建立预紧力测量的理论计算模型,并可用此模型较精确地确定预紧力,为轴承预紧力设计和装配提供参考.%Bearings are a necessary part of mechanism, and have been widely used in various mechanical systems, such as agricultural machinery, engineering machinery, precision machinery, aerospace machinery. The preload of bearings affects bearing stiffness, rotating precision and service life. Meanwhile, precise determination of bearing preload is the guarantee for the high-precision bearing support system. Related determining preloads have already been analyzed, but the literatures don't consider the interception of friction at fitting area. Space bearing works in space environment, and it is essential to accurately determine the preload. If the initial preload is not selected appropriately or accurately, the changes of preload induced by

  2. Effects of the search technique on the measurement of the change in quality of randomized controlled trials over time in the field of brain injury

    Directory of Open Access Journals (Sweden)

    Yamada Chisa

    2005-02-01

    Full Text Available Abstract Background To determine if the search technique that is used to sample randomized controlled trial (RCT manuscripts from a field of medical science can influence the measurement of the change in quality over time in that field. Methods RCT manuscripts in the field of brain injury were identified using two readily-available search techniques: (1 a PubMed MEDLINE search, and (2 the Cochrane Injuries Group (CIG trials registry. Seven criteria of quality were assessed in each manuscript and related to the year-of-publication of the RCT manuscripts by regression analysis. Results No change in the frequency of reporting of any individual quality criterion was found in the sample of RCT manuscripts identified by the PubMed MEDLINE search. In the RCT manuscripts of the CIG trials registry, three of the seven criteria showed significant or near-significant increases over time. Conclusions We demonstrated that measuring the change in quality over time of a sample of RCT manuscripts from the field of brain injury can be greatly affected by the search technique. This poorly recognized factor may make measurements of the change in RCT quality over time within a given field of medical science unreliable.

  3. No Influence of Transcutaneous Electrical Nerve Stimulation on Exercise-Induced Pain and 5-Km Cycling Time-Trial Performance

    Science.gov (United States)

    Hibbert, Andrew W.; Billaut, François; Varley, Matthew C.; Polman, Remco C. J.

    2017-01-01

    Introduction: Afferent information from exercising muscle contributes to the sensation of exercise-induced muscle pain. Transcutaneous electrical nerve stimulation (TENS) delivers low–voltage electrical currents to the skin, inhibiting nociceptive afferent information. The use of TENS in reducing perceptions of exercise-induced pain has not yet been fully explored. This study aimed to investigate the effect of TENS on exercise-induced muscle pain, pacing strategy, and performance during a 5-km cycling time trial (TT). Methods: On three separate occasions, in a single-blind, randomized, and cross-over design, 13 recreationally active participants underwent a 30-min TENS protocol, before performing a 5-km cycling TT. TENS was applied to the quadriceps prior to exercise under the following conditions; control (CONT), placebo with sham TENS application (PLAC), and an experimental condition with TENS application (TENS). Quadriceps fatigue was assessed with magnetic femoral nerve stimulation assessing changes in potentiated quadriceps twitch force at baseline, pre and post exercise. Subjective scores of exertion, affect and pain were taken every 1-km. Results: During TTs, application of TENS did not influence pain perceptions (P = 0.68, ηp2 = 0.03). There was no significant change in mean power (P = 0.16, ηp2 = 0.16) or TT duration (P = 0.17, ηp2 = 0.14), although effect sizes were large for these two variables. Changes in power output were not significant but showed moderate effect sizes at 500-m (ηp2 = 0.10) and 750-m (ηp2 = 0.10). Muscle recruitment as inferred by electromyography data was not significant, but showed large effect sizes at 250-m (ηp2 = 0.16), 500-m (ηp2 = 0.15), and 750-m (ηp2 = 0.14). This indicates a possible effect for TENS influencing performance up to 1-km. Discussion: These findings do not support the use of TENS to improve 5-km TT performance. PMID:28223939

  4. Evaluation of the UP4FUN intervention: a cluster randomized trial to reduce and break up sitting time in European 10-12-year-old children.

    Directory of Open Access Journals (Sweden)

    Frøydis N Vik

    Full Text Available The UP4FUN intervention is a family-involved school-based intervention aiming at reducing and breaking up sitting time at home (with special emphasis on screen time, and breaking up sitting time in school among 10-12 year olds in Europe. The purpose of the present paper was to evaluate its short term effects.A total of 3147 pupils from Belgium, Germany, Greece, Hungary and Norway participated in a school-randomized controlled trial. The intervention included 1-2 school lessons per week for a period of six weeks, along with assignments for the children and their parents. Screen time and breaking up sitting time were registered by self-report and total sedentary time and breaking up sitting time by accelerometry. The effect of the intervention on these behaviors was evaluated by multilevel regression analyses. All analyses were adjusted for baseline values and gender. Significance level was p≤0.01. No significant intervention effects were observed, neither for self-reported TV/DVD or computer/game console time, nor for accelerometer-assessed total sedentary time and number of breaks in sitting time. The intervention group, however, reported more positive attitudes towards (β = 0.25 (95% CI 0.11, 0.38 and preferences/liking for (β = 0.20 (95% CI 0.08, 0.32 breaking up sitting time than the control group.No significant intervention effect on self-reported screen time or accelerometer-assessed sedentary time or breaks in sitting time was observed, but positive effects on beliefs regarding breaking up sitting time were found in favor of the intervention group. Overall, these results do not warrant wider dissemination of the present UP4FUN intervention.International Standard Randomized Controlled Trial Number Registry ISRCTN34562078.

  5. A randomised trial of timed delivery for the compromised preterm fetus : short term outcomes and Bayesian interpretation

    NARCIS (Netherlands)

    Van Bulck, B; Kalakoutis, GM; Sak, P; Schneider, KTM; Major, T; Karpathios, SE; Todros, T; Arduini, D; Tranquilli, A; Tenore, AC; Roncaglia, N; Frusca, T; van Roosmalen, J; van der Slikke, JW; van Geijn, H; Pernet, PJM; Wolf, H; Stitger, RH; Wilczynski, J; Vasco, E; Rashid, M; Novak-Antolic, Z; Danielian, P; Jenkinson, SD; Welch, CR; Griffin, C; Gee, H; Tuffnell, D; Cresswell, J; Tariq, T; Sengupta, B; Tydeman, G; Kumarendran, M; Churchill, D; Bewley, S; Fusi, L; Lindow, SW; Johal, W; Neales, K; Thornton, JG; Scudamore, [No Value; Konje, J; Walkinshaw, SA; Griffiths, M; Dawson, A; Mires, G; Johanson, R; Fraser, RB; Hendy, P; Steel, SA; Ramsay, M; Robins, JB; Heard, MJ; Tonge, HM; Manyonda, IT; Walker, J; Maresh, M; Yoong, A; Cameron, H; Byrne, D; Beattie, B; Bober, S

    2003-01-01

    Objectives To compare the effect of delivering early to pre-empt terminal hypoxaemia with delaying for as long as possible to increase maturity. Design A randomised controlled trial. Setting 69 hospitals in 13 European countries. Participants Pregnant women with fetal compromise between 24 and 36 we

  6. Omission of the bladder flap at caesarean section reduces delivery time without increased morbidity: a meta-analysis of randomised controlled trials.

    Science.gov (United States)

    O'Neill, Heidi A; Egan, Grace; Walsh, Colin A; Cotter, Amanda M; Walsh, Stewart R

    2014-03-01

    Caesarean section (CS) is the most common major surgical procedure performed worldwide. Traditionally, creation of a bladder flap (BF) has been a routine surgical step at CS although recent randomised controlled trials (RCTs) have begun to question its value. We performed a meta-analysis of RCTs examining the benefits of BF formation at CS. Pubmed, Medline, Embase, CINAHL Plus(®), Web of Science Reference and Cochrane Databases online were searched in March 2012 using combinations of the terms "c(a)esarean", "bladder", "flap" and "technique". Citations identified in the primary search were screened for eligibility. Online clinical registries (www.clinicaltrials.gov, www.controlled-trials.com and www.ukcrc.org.) were also searched. The primary outcome was bladder injury. Secondary outcomes were skin incision-delivery interval, total operating time, blood loss and duration of hospitalisation. Pooled outcome measures (odds ratio [OR] and weighted mean difference [WMD]) were calculated using a random effects model. Three published RCTs and one unpublished trial identified from an online trial registry were included (n=581 women). All four trials excluded very preterm and emergency CS. Omission of the BF step at CS reduced the skin incision-delivery interval (WMD 1.27min; p=0.0001). No differences were found for bladder injury (pooled OR 0.96), total operating time (WMD 3.5min), blood loss (WMD 42ml) or duration of hospitalisation (WMD 0.07 days). Omission of the BF at elective CS does not appear to increase the rate of peri-operative complications and improves the skin incision-delivery interval. The role of BF formation in very preterm procedures and emergency intrapartum CS needs further study. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  7. Induction chemotherapy before chemoradiotherapy and surgery for locally advanced rectal cancer. Is it time for a randomized phase III trial?

    Energy Technology Data Exchange (ETDEWEB)

    Roedel, Claus [Frankfurt Univ. (Germany). Klinik fuer Strahlentherapie und Onkologie; Arnold, Dirk [Halle Univ. (Germany). Klinik und Poliklinik fuer Innere Medizin IV; Becker, Heinz; Ghadimi, Michael; Liersch, Torsten [Goettingen Univ. (Germany). Klinik fuer Allgemein- und Visceralchirurgie; Fietkau, Rainer; Sauer, Rolf [Erlangen Univ. (Germany). Strahlenklinik; Graeven, Ullrich [Kliniken Maria Hilf GmbH, Moenchengladbach (Germany). Klinik fuer Haematologie, Onkologie und Gastroenterologie; Hess, Clemens [Goettingen Univ. (Germany). Klinik fuer Strahlentherapie und Radioonkologie; Hofheinz, Ralf [Universitaetsmedizin Mannheim (Germany). III. Medizinische Klinik Haematologie und Internistische Onkologie; Hohenberger, Werner [Erlangen Univ. (Germany). Chirurgische Klinik; Post, Stefan [Universitaetsmedizin Mannheim (Germany). Chirurgische Klinik; Raab, Rudolf [Klinikum Oldenburg (Germany). Klinik fuer Allgemein- und Visceralchirurgie; Wenz, Frederick [Universitaetsmedizin Mannheim (Germany). Klinik fuer Strahlentherapie und Radioonkologie

    2010-12-15

    Background: In the era of preoperative chemoradiotherapy (CRT) and total mesorectal excision (TME), the development of distant metastases is the predominant mode of failure in rectal cancer patients today. Integrating more effective systemic therapy into combined modality programs is the challenge. The question that needs to be addressed is how and when to apply systemic treatment with adequate dose and intensity. Material and Methods: This review article focuses on phase II-III trials designed to improve 5-fluorouracil (5-FU)-based combined modality treatment for rectal cancer patients through the inclusion of concurrent, adjuvant or, most recently, induction combination chemotherapy. Computerized bibliographic searches of PubMed were supplemented with hand searches of reference lists and abstracts of ASCO/ASTRO/ESTRO meetings. Results: After preoperative CRT and surgical resection, approximately one third of patients do not receive adjuvant chemotherapy, mainly due to surgical complications, patients' refusal, or investigator's discretion. In order to be able to apply chemotherapy with sufficient dose and intensity, an innovative approach is to deliver systemic therapy prior to preoperative CRT rather than adjuvant chemotherapy. Emerging evidence from several phase II trials and, recently, randomized phase II trials indicate that induction chemotherapy is feasible, does not compromise CRT or surgical resection, and enables the delivery of chemotherapy in adequate dose and intensity. Although this approach did not increase local efficacy in recent trials (e.g., pathological complete response rates, tumor regression, R0 resection rates, local control), it may help to improve control of distant disease. Conclusion: Whether this improvement in applicability and dose density of chemotherapy will ultimately translate into improved disease-free survival will have to be tested in a larger phase III trial. (orig.)

  8. Ringer’s lactate, but not hydroxyethyl starch, prolongs the food intolerance time after major abdominal surgery; an open-labelled clinical trial

    OpenAIRE

    Li, Yuhong; He, Rui; Ying, Xiaojiang; Hahn, Robert

    2015-01-01

    Background: The infusion of large amounts of Ringers lactate prolongs the functional gastrointestinal recovery time and increases the number of complications after open abdominal surgery. We performed an open-labelled clinical trial to determine whether hydroxyethyl starch or Ringers lactate exerts these adverse effects when the surgery is performed by laparoscopy. Methods: Eighty-eight patients scheduled for major abdominal cancer surgery (83% by laparoscopy) received a first-line fluid trea...

  9. Hemiepiphysiodesis: similar treatment time for tension-band plating and for stapling: a randomized clinical trial on guided growth for idiopathic genu valgum.

    Science.gov (United States)

    Gottliebsen, Martin; Rahbek, Ole; Hvid, Ivan; Davidsen, Michael; Hellfritzsch, Michel Bach; Møller-Madsen, Bjarne

    2013-04-01

    In children with angulating deformities of the lower limbs, hemiepiphysiodesis can be used to guide growth to achieve better alignment at skeletal maturity. Traditionally, this has been performed with staples. The tension-band plating technique is new and it has been advocated because it is believed to reduce the risk of premature closure of the growth plate compared to stapling. The benefit of the tension-band plating technique has not yet been proven in experimental or randomized clinical studies. We performed a randomized clinical trial in which 26 children with idiopathic genu valgum were allocated to stapling or tension-band plating hemiepiphysiodesis. Time to correction of the deformity was recorded and changes in angles on long standing radiographs were measured. Pain score using visual analog scale (VAS) was recorded for the first 72 h postoperatively. Analgesics taken were recorded by the parents. Mean treatment times for stapling hemiepiphysiodesis (n = 10) and for tension-band plating hemiepiphysiodesis (n = 10) were similar. Postoperative VAS scores and consumption of analgesics were also similar in both groups. No hardware failure or wound-related infection was observed. Treatment time for the 2 treatment modalities was not significantly different in this randomized clinical trial. Tension-band plating and stapling appeared to have a similar effect regarding correction of genu valgum. We cannot rule out type-II error and the possibility that our study was underpowered. ClinicalTrials.gov Identifier: NCT01641354.

  10. Preloading Monitoring Methods for Large Oil Tank in Algeria 5 MTPY Condensate Project%阿尔及利亚凝析油项目大型油罐充水预压动态监控方法

    Institute of Scientific and Technical Information of China (English)

    祖兴和; 周旭荣

    2009-01-01

    简要介绍了阿尔及利用亚凝析油项目场区工程地质条件、充水预压的主要特点与充水预压的主要动态监控措施.该工程经充水预压施工与动态监测控制,保证了大型油罐设计与施工的经济合理、安全可靠,避免了重大的建设资金浪费和工期损失.该工程的成果与经验对软土地基上的大型油罐的设计、施工和监测等具有重要的参考意义.%By the dynamic monitoring & controlling for the large oil tanks, the engineering & construction of the tanks is economic, reasonable, safe & reliable in Algeria 5MTPY Condensate roject. Big waste is avoided on construction fund and time in the project. The site engineering geological condition, main characteristics of preloading, main dynamic monitoring & controlling measures are introduced briefly in this paper. The fruit and experience in the project has important reference sense to the engineering, construction & monitoring of large oil tanks in soft soil area.

  11. Study on Soft Roadbed Reinforcement Based on Vacuum Combined Surcharge Preloading Method%基于真空联合堆载预压法的软土路基加固技术问题研究

    Institute of Scientific and Technical Information of China (English)

    李鹏

    2015-01-01

    因软粘土具有高含水量、大孔隙、低强度、高压缩性、低透水性等特点,导致其土层压缩沉降量大,排水固结缓慢,沉降稳定时间很长,地基稳定性差,难以满足工程需要。本文以青岛高新区双高公路工程为例,对真空联合堆载预压法加固公路软基的机理、特点及加固效果进行了深入研究,为工程应用提供参考。%Characterized by high water content、macroporosity、low intensity、high compressibility and low permeabilit-y, the soft clay is easy to lead to big soil compression settlement , slow drainage consolidation, long settlement stable time, poor reliability. It doesn't meet the needs of the engineering. This paper analyzes the mechanism、characteristics and reinforcement effect of vacuum combined surcharge preloading method about the expressway of Qingdao high-tech zone. The results can be referred to for engineering application.

  12. Numerical Study Of The Effects Of Preloading, Axial Loading And Concrete Shrinkage On Reinforced Concrete Elements Strengthened By Concrete Layers And Jackets

    Science.gov (United States)

    Lampropoulos, A. P.; Dritsos, S. E.

    2008-07-01

    In this study, the technique of seismic strengthening existing reinforced concrete columns and beams using additional concrete layers and jackets is examined. The finite element method and the finite element program ATENA is used in this investigation. When a reinforced jacket or layer is being constructed around a column it is already preloaded due to existing service loads. This effect has been examined for different values of the axial load normalized to the strengthened column. The techniques of strengthening with a concrete jacket or a reinforced concrete layer on the compressive side of the column are examined. Another phenomenon that is examined in this study is the shrinkage of the new concrete of an additional layer used to strengthen an existing member. For this investigation, a simply supported beam with an additional reinforced concrete layer on the tensile side is examined. The results demonstrate that the effect of preloading is important when a reinforced concrete layer is being used with shear connectors between the old and the new reinforcement. It was also found that the shrinkage of the new concrete reduces the strength of the strengthened beam and induces an initial sliding between the old and the new concrete.

  13. Randomised controlled Trial of Improvisational Music therapy's Effectiveness for children with Autism spectrum disorders (TIME-A)

    DEFF Research Database (Denmark)

    Geretsegger, Monika; Holck, Ulla; Gold, Christian

    2012-01-01

    design with first interim look at N = 235 will ensure both power and efficiency. Discussion Responding to the need for more rigorously designed trials examining the effectiveness of music therapy in autism spectrum disorders, this pragmatic trial sets out to generate findings that will be well...... sessions of parent counselling (at 0, 2, and 5 months). In addition, children randomised to the two intervention groups will be offered individual, improvisational music therapy over a period of five months, either one session (low-intensity) or three sessions (high-intensity) per week. Generalised effects...... of music therapy will be measured using standardised scales completed by blinded assessors (Autism Diagnostic Observation Schedule, ADOS) and parents (Social Responsiveness Scale, SRS) before and 2, 5, and 12 months after randomisation. Cost effectiveness will be calculated as man years. A group sequential...

  14. Is it Time to Change the Control Placebo Arms in Phase III Trials of Metastatic Castration Resistant Prostate Cancer?

    Science.gov (United States)

    Dogan, Mutlu; Erdem, Gokmen Umut; Zengin, Nurullah

    2015-01-01

    Prostate cancer is common all around the world. Hormonal therapy is the mainstay of therapy, however castration-resistant prostate cancer (CRPC) becomes a serious problem and needs further clinical trials with novel agents. Novel agents like cabazitaxel, abireterone acetate or enzalutamide are encouraging but we do not know which one is the best in metastatic CRPC. In here, treatment modalities for metastatic CRPC are discussed witha mini-review of the literature.

  15. Randomised controlled trial of improvisational music therapy's effectiveness for children with autism spectrum disorders (TIME-A: study protocol

    Directory of Open Access Journals (Sweden)

    Geretsegger Monika

    2012-01-01

    Full Text Available Abstract Background Previous research has suggested that music therapy may facilitate skills in areas typically affected by autism spectrum disorders such as social interaction and communication. However, generalisability of previous findings has been restricted, as studies were limited in either methodological accuracy or the clinical relevance of their approach. The aim of this study is to determine effects of improvisational music therapy on social communication skills of children with autism spectrum disorders. An additional aim of the study is to examine if variation in dose of treatment (i.e., number of music therapy sessions per week affects outcome of therapy, and to determine cost-effectiveness. Methods/Design Children aged between 4;0 and 6;11 years who are diagnosed with autism spectrum disorder will be randomly assigned to one of three conditions. Parents of all participants will receive three sessions of parent counselling (at 0, 2, and 5 months. In addition, children randomised to the two intervention groups will be offered individual, improvisational music therapy over a period of five months, either one session (low-intensity or three sessions (high-intensity per week. Generalised effects of music therapy will be measured using standardised scales completed by blinded assessors (Autism Diagnostic Observation Schedule, ADOS and parents (Social Responsiveness Scale, SRS before and 2, 5, and 12 months after randomisation. Cost effectiveness will be calculated as man years. A group sequential design with first interim look at N = 235 will ensure both power and efficiency. Discussion Responding to the need for more rigorously designed trials examining the effectiveness of music therapy in autism spectrum disorders, this pragmatic trial sets out to generate findings that will be well generalisable to clinical practice. Addressing the issue of dose variation, this study's results will also provide information on the relevance of session

  16. Design and semiparametric analysis of non-inferiority trials with active and placebo control for censored time-to-event data.

    Science.gov (United States)

    Kombrink, Karola; Munk, Axel; Friede, Tim

    2013-08-15

    The clinical trial design including a test treatment, an active control and a placebo is called the gold standard design. In this paper, we develop a statistical method for planning and evaluating non-inferiority trials with gold standard design for right-censored time-to-event data. We consider both lost to follow-up and administrative censoring. We present a semiparametric approach that only assumes the proportionality of the hazard functions. In particular, we develop an algorithm for calculating the minimal total sample size and its optimal allocation to treatment groups such that a desired power can be attained for a specific parameter constellation under the alternative. For the purpose of sample size calculation, we assume the endpoints to be Weibull distributed. By means of simulations, we investigate the actual type I error rate, power and the accuracy of the calculated sample sizes. Finally, we compare our procedure with a previously proposed procedure assuming exponentially distributed event times. To illustrate our method, we consider a double-blinded, randomized, active and placebo controlled trial in major depression. Copyright © 2013 John Wiley & Sons, Ltd.

  17. Impact of Global Geographic Region on Time in Therapeutic Range on Warfarin Anticoagulant Therapy: Data From the ROCKET AF Clinical Trial

    Science.gov (United States)

    Singer, Daniel E.; Hellkamp, Anne S.; Piccini, Jonathan P.; Mahaffey, Kenneth W.; Lokhnygina, Yuliya; Pan, Guohua; Halperin, Jonathan L.; Becker, Richard C.; Breithardt, Günter; Hankey, Graeme J.; Hacke, Werner; Nessel, Christopher C.; Patel, Manesh R.; Califf, Robert M.; Fox, Keith A. A.

    2013-01-01

    Background Vitamin K antagonist (VKA) therapy remains the most common method of stroke prevention in patients with atrial fibrillation. Time in therapeutic range (TTR) is a widely cited measure of the quality of VKA therapy. We sought to identify factors associated with TTR in a large, international clinical trial. Methods and Results TTR (international normalized ratio [INR] 2.0 to 3.0) was determined using standard linear interpolation in patients randomized to warfarin in the ROCKET AF trial. Factors associated with TTR at the individual patient level (i‐TTR) were determined via multivariable linear regression. Among 6983 patients taking warfarin, recruited from 45 countries grouped into 7 regions, the mean i‐TTR was 55.2% (SD 21.3%) and the median i‐TTR was 57.9% (interquartile range 43.0% to 70.6%). The mean time with INR 3 was 15.7%. While multiple clinical features were associated with i‐TTR, dominant determinants were previous warfarin use (mean i‐TTR of 61.1% for warfarin‐experienced versus 47.4% in VKA‐naïve patients) and geographic region where patients were managed (mean i‐TTR varied from 64.1% to 35.9%). These effects persisted in multivariable analysis. Regions with the lowest i‐TTRs had INR distributions shifted toward lower INR values and had longer inter‐INR test intervals. Conclusions Independent of patient clinical features, the regional location of medical care is a dominant determinant of variation in i‐TTR in global studies of warfarin. Regional differences in mean i‐TTR are heavily influenced by subtherapeutic INR values and are associated with reduced frequency of INR testing. Clinical Trial Registration URL: ClinicalTrials.gov. Unique identifier: NCT00403767. PMID:23525418

  18. Effect of a novel two-desk sit-to-stand workplace (ACTIVE OFFICE) on sitting time, performance and physiological parameters: protocol for a randomized control trial.

    Science.gov (United States)

    Schwartz, Bernhard; Kapellusch, Jay M; Schrempf, Andreas; Probst, Kathrin; Haller, Michael; Baca, Arnold

    2016-07-15

    Prolonged sitting is ubiquitous in modern society and linked to several diseases. Height-adjustable desks are being used to decrease worksite based sitting time (ST). Single-desk sit-to-stand workplaces exhibit small ST reduction potential and short-term loss in performance. The aim of this paper is to report the study design and methodology of an ACTIVE OFFICE trial. The study was a 1-year three-arm, randomized controlled trial in 18 healthy Austrian office workers. Allocation was done via a regional health insurance, with data collection during Jan 2014 - March 2015. Participants were allocated to either an intervention or control group. Intervention group subjects were provided with traditional or two-desk sit-to-stand workstations in either the first or the second half of the study, while control subjects did not experience any changes during the whole study duration. Sitting time and physical activity (IPAQ-long), cognitive performance (text editing task, Stroop-test, d2R test of attention), workload perception (NASA-TLX) and physiological parameters (salivary cortisol, heartrate variability and body weight) were measured pre- and post-intervention (23 weeks after baseline) for intervention and control periods. Postural changes and sitting/standing time (software logger) were recorded at the workplace for the whole intervention period. This study evaluates the effects of a novel two-desk sit-to-stand workplace on sitting time, physical parameters and work performance of healthy office based workers. If the intervention proves effective, it has a great potential to be implemented in regular workplaces to reduce diseases related to prolonged sitting. ClinicalTrials.gov Identifier: NCT02825303 , July 2016 (retrospectively registered).

  19. The effect of foot reflexology on physiologic parameters and mechanical ventilation weaning time in patients undergoing open-heart surgery: A clinical trial study.

    Science.gov (United States)

    Ebadi, Abbas; Kavei, Parastoo; Moradian, Seyyed Tayyeb; Saeid, Yaser

    2015-08-01

    The aim of this study was to investigate the efficacy of foot reflexology on physiological parameters and mechanical ventilation weaning time in patients undergoing open-heart surgery. This was a double blind three-group randomized controlled trial. Totally, 96 patients were recruited and randomly allocated to the experimental, placebo, and the control groups. Study groups respectively received foot reflexology, simple surface touching, and the routine care of the study setting. Physiological parameters (pulse rate, respiratory rate, systolic and diastolic blood pressures, mean arterial pressure, percutaneous oxygen saturation) and weaning time were measured. The study groups did not differ significantly in terms of physiological parameters (P value > 0.05). However, the length of weaning time in the experimental group was significantly shorter than the placebo and the control groups (P value reflexology in shortening the length of weaning time.

  20. 染料预负载树脂对Cu(Ⅱ)的吸附作用特性%ADSORPTION OF Cu(H) ON DYE-PRELOADED RESIN

    Institute of Scientific and Technical Information of China (English)

    凌晨; 刘福强; 陈泰鹏; 龙超; 吴秋原; 李爱民

    2013-01-01

    通过预负载实验,研究了染料预负载超高交联吸附树脂NDA-150对Cu(Ⅱ)的作用持性.研究结果表明,NDA-150负载酸性蓝29的能力很强,但对Cu(U)吸附极弱.预负载酸性蓝29显著提高了NDA-150对Cu(Ⅱ)的吸附能力,而且随染料负载量的增加,Cu(Ⅱ)的吸附量呈阶段性的线性增长,单位增长倍率先增后降呈现两个阶段.FT-IR和XPS的表征结果显示,固相上染料分子中磺酸基、氨基及羟基参与了对Cu(Ⅱ)的吸附,这为染料预负载增强了树脂对Cu(Ⅱ)的吸附亲和力提供了直接证据.通过Ca(Ⅱ)屏蔽位点实验,表明固相中染料分子主要为Cu(Ⅱ)的吸附提供离子交换位点,此外还提供部分螯合位点.由此可见,超高交联吸附树脂NDA-150有可能同时去除废水中染料及共存重金属离子.%The influence of dye preloaded on the adsorption of Cu(Ⅱ) with hypercrosslinked polymeric resin NDA-150 was studied. Acid Blue 29 preloaded markedly enhanced the adsorption capacity of Cu(Ⅱ) on the resin. With the increase of preloading concentration, the adsorption capacity of Cu(Ⅱ) presented a periodically linear growth, while the enhancement amount contributed by per mole AB (ER) increased first and decreased afterwards. Based on the experimental results of FT-IR and XPS, the adsorption of Cu(Ⅱ) was improved by the interaction of Cu(Ⅱ) with -SOaNa, -NH2, and -OH group in the adsorbed dye molecules. The inside enhancement mechanisms were also examined by performing sites pre-shielding experiment and the results demonstrated that interactions between Cu(Ⅱ) and AB were composed of both ion exchange and coordination. NDA-15 resin can simultaneously remove dye and heavy metal ions from wastewater.

  1. Analysis of Workflow and Time to Treatment and the Effects on Outcome in Endovascular Treatment of Acute Ischemic Stroke: Results from the SWIFT PRIME Randomized Controlled Trial.

    Science.gov (United States)

    Goyal, Mayank; Jadhav, Ashutosh P; Bonafe, Alain; Diener, Hans; Mendes Pereira, Vitor; Levy, Elad; Baxter, Blaise; Jovin, Tudor; Jahan, Reza; Menon, Bijoy K; Saver, Jeffrey L

    2016-06-01

    Purpose To study the relationship between functional independence and time to reperfusion in the Solitaire with the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) trial in patients with disabling acute ischemic stroke who underwent endovascular therapy plus intravenous tissue plasminogen activator (tPA) administration versus tPA administration alone and to investigate variables that affect time spent during discrete steps. Materials and Methods Data were analyzed from the SWIFT PRIME trial, a global, multicenter, prospective study in which outcomes were compared in patients treated with intravenous tPA alone or in combination with the Solitaire device (Covidien, Irvine, Calif). Between December 2012 and November 2014, 196 patients were enrolled. The relation between time from (a) symptom onset to reperfusion and (b) imaging to reperfusion and clinical outcome was analyzed, along with patient and health system characteristics that affect discrete steps in patient workflow. Multivariable logistic regression was used to assess relationships between time and outcome; negative binomial regression was used to evaluate effects on workflow. The institutional review board at each site approved the trial. Patients provided written informed consent, or, at select sites, there was an exception from having to acquire explicit informed consent in emergency circumstances. Results In the stent retriever arm of the study, symptom onset to reperfusion time of 150 minutes led to 91% estimated probability of functional independence, which decreased by 10% over the next hour and by 20% with every subsequent hour of delay. Time from arrival at the emergency department to arterial access was 90 minutes (interquartile range, 69-120 minutes), and time to reperfusion was 129 minutes (interquartile range, 108-169 minutes). Patients who initially arrived at a referring facility had longer symptom onset to groin puncture times compared with

  2. Reducing bed rest time from five to three hours does not increase complications after cardiac catheterization: the THREE CATH Trial 1

    Science.gov (United States)

    Matte, Roselene; Hilário, Thamires de Souza; Reich, Rejane; Aliti, Graziella Badin; Rabelo-Silva, Eneida Rejane

    2016-01-01

    Abstract Objective: to compare the incidence of vascular complications in patients undergoing transfemoral cardiac catheterization with a 6F introducer sheath followed by 3-hour versus 5-hour rest. Methods: randomized clinical trial. Subjects in the intervention group (IG) ambulated 3 hours after sheath removal, versus 5 hours in the control group (CG). All patients remained in the catheterization laboratory for 5 hours and were assessed hourly, and were contacted 24, 48, and 72 h after hospital discharge. Results: the sample comprised 367 patients in the IG and 363 in the GC. During cath lab stay, hematoma was the most common complication in both groups, occurring in 12 (3%) IG and 13 (4%) CG subjects (P=0.87). Bleeding occurred in 4 (1%) IG and 6 (2%) CG subjects (P=0.51), and vasovagal reaction in 5 (1.4%) IG and 4 (1.1%) CG subjects (P=0.75). At 24-h, 48-h, and 72-h bruising was the most commonly reported complication in both groups. None of the comparisons revealed any significant between-group differences. Conclusion: the results of this trial show that reducing bed rest time to 3 hours after elective cardiac catheterization is safe and does not increase complications as compared with a 5-hour rest. ClinicalTrials.gov Identifier: NCT-01740856 PMID:27463113

  3. Time from prior chemotherapy enhances prognostic risk grouping in the second-line setting of advanced urothelial carcinoma: a retrospective analysis of pooled, prospective phase 2 trials.

    Science.gov (United States)

    Sonpavde, Guru; Pond, Gregory R; Fougeray, Ronan; Choueiri, Toni K; Qu, Angela Q; Vaughn, David J; Niegisch, Guenter; Albers, Peter; James, Nicholas D; Wong, Yu-Ning; Ko, Yoo-Joung; Sridhar, Srikala S; Galsky, Matthew D; Petrylak, Daniel P; Vaishampayan, Ulka N; Khan, Awais; Vogelzang, Nicholas J; Beer, Tomasz M; Stadler, Walter M; O'Donnell, Peter H; Sternberg, Cora N; Rosenberg, Jonathan E; Bellmunt, Joaquim

    2013-04-01

    Outcomes for patients in the second-line setting of advanced urothelial carcinoma (UC) are dismal. The recognized prognostic factors in this context are Eastern Cooperative Oncology Group (ECOG) performance status (PS) >0, hemoglobin level (Hb) value of time from prior chemotherapy (TFPC) independent of known prognostic factors. Data from patients from seven prospective trials with available baseline TFPC, Hb, PS, and LM values were used for retrospective analysis (n=570). External validation was conducted in a second-line phase 3 trial comparing best supportive care (BSC) versus vinflunine plus BSC (n=352). Cox proportional hazards regression was used to evaluate the association of factors, with overall survival (OS) and progression-free survival (PFS) being the respective primary and secondary outcome measures. ECOG-PS >0, LM, Hb 0, Hb <10 g/dl, and LM in the setting of second-line therapy for advanced UC. These data may facilitate drug development and interpretation of trials. Copyright © 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.

  4. 血管外肺水和容量指标在感染性休克患者呼吸机撤离中的临床意义%Clinical value of extravascular lung water and preload parameters in weaning of mechanical ventilation in patients with septic shock

    Institute of Scientific and Technical Information of China (English)

    方明; 曾红科; 陈淼; 郑崇伟; 邓医宇; 胡北; 柳学; 黄伟平; 龙怡; 蒋文新

    2013-01-01

    Objective To investigate the values of extravascular lung water and preload parameters of weaning from mechanical ventilation on patients with septic shock.Methods A prospective study was conducted.A total of 52 septic shock patients with mechanical ventilation were enrolled from January 2010 to July 2012.All patients were treated and monitored by pulse induced continuous cardiac output (PiCCO) till they reached weaning criteria,and then spontaneous breathing trial (SBT),weaning,and extubation were performed in turn.The enrolled patients were divided into two groups including successful weaning group (n =38) and weaning failure group (n =14) according to clinical manifestations during 48 hours after weaning.Extravascular lung water index (EVLWI),preload parameters such as global end diastolic volume index (GEDVI) and intra-thoracic blood volume index (ITBVI),pulmonary vascular permeability index (PVPI) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) were compared at the time before weaning,0.5 hour after weaning,0.5 hour after extubation,and time of weaning failure or 48 hours after weaning.The patients in weaning failure group were sub-divided into high PVPI group (PVPI ≥ 1.5 ml/m2) and low PVPI group (PVPI< 1.5 ml/m2),the NT-proBNP and pulmonary blood volume (PBV) were compared between two groups.Results Before weaning,there was no statistical difference in NT-proBNP,volume parameters and EVLWI between two groups.EVLWI,GEDVI,ITBVI,PVPI and log NT-proBNP were gradually increased after weaning and extubation in two groups.The EVLWI (ml/kg),PVPI (ml/m2) and log NT-proBNP were significantly higher at end point of observation in weaning failure group compared with those in successful weaning group (EVLWI:12.81 ± 2.13 vs.8.48 ± 1.53,PVPI:2.79 ± 1.29 vs.2.19 ± 0.94,log NT-proBNP:3.72 ± 0.35 vs.3.44 ± 0.28,P<0.05 or P<0.01).GEDVI (ml/m2),ITBVI (ml/m2) at 0.5 hour after weaning and end point of observation in weaning failure group were

  5. Beetroot Juice Improves On-Water 500 M Time-Trial Performance, and Laboratory-Based Paddling Economy in National and International-Level Kayak Athletes.

    Science.gov (United States)

    Peeling, Peter; Cox, Gregory R; Bullock, Nicola; Burke, Louise M

    2015-06-01

    We assessed the ingestion of a beetroot juice supplement (BR) on 4-min laboratory-based kayak performance in national level male (n = 6) athletes (Study A), and on 500 m on-water kayak time-trial (TT) performance in international level female (n = 5) athletes (Study B). In Study A, participants completed three laboratory-based sessions on a kayak ergometer, including a 7 × 4 min step test, and two 4 min maximal effort performance trials. Two and a half hours before the warm-up of each 4 min performance trial, athletes received either a 70 ml BR shot containing ~4.8 mmol of nitrate, or a placebo equivalent (BRPLA). The distance covered over the 4 min TT was not different between conditions; however, the average VO2 over the 4 min period was significantly lower in BR (p = .04), resulting in an improved exercise economy (p = .05). In Study B, participants completed two field-based 500 m TTs, separated by 4 days. Two hours before each trial, athletes received either two 70 ml BR shots containing ~9.6 mmol of nitrate, or a placebo equivalent (BRPLA). BR supplementation significantly enhanced TT performance by 1.7% (p = .01). Our results show that in national-level male kayak athletes, commercially available BR shots (70 ml) containing ~4.8 mmol of nitrate improved exercise economy during laboratory-based tasks predominantly reliant on the aerobic energy system. Furthermore, greater volumes of BR (140 ml; ~9.6 mmol nitrate) provided to international-level female kayak athletes resulted in enhancements to TT performance in the field.

  6. Pharmacological trials in migraine: it's time to reappraise where the headache is and what the pain is like.

    Science.gov (United States)

    Barbanti, Piero; Egeo, Gabriella

    2015-03-01

    Most pharmacological trials deal with migraine as if it were a clinically homogeneous disease, and when detailing its characteristics, they usually report only the presence, or absence, of aura and attack frequency but provide no information on pain location, a non-trivial clinical detail. The past decade has witnessed growing emerging evidence suggesting that individuals with unilateral pain, especially those with associated unilateral cranial autonomic symptoms, are more responsive than others to trigeminal-targeted symptomatic and preventive therapy with drugs such as triptans or botulinum toxin. A simple way for migraine research treatment to take a step forward might be to step back, reappraise, and critically evaluate easily obtainable patient-reported clinical findings along with current knowledge on pain features.

  7. Value of a single night-time dose of potassium clorazepate in anxiety: a controlled trial comparison with diazepam.

    Science.gov (United States)

    Henderson, J G

    1982-10-01

    A total of 29 patients with anxiety or anxiety/hysteria, participated in a double-blind, cross-over trial of two benzodiazepine anxiolytics, diazepam and potassium clorazepate. The problems of a 'carry-over' effect and a possible order of drug administration effect are discussed in relation to analysis of results. Clorazepate proved the more effective drug, as shown by a reduction in total symptom scale of Kellner Symptom Rating Test and the reduction in sub-scales for anxiety, depression, somatic complaints and general neurotic symptoms with parallel symptom reduction in linear analogue scales. Side effects were infrequent with both drugs and posed no clinical problem. Potassium clorazepate in a single nightly dose of 15 mg proved to be more effective than thrice daily (5 mg) diazepam.

  8. Effect of timing of umbilical cord clamping on iron status in Mexican infants: a randomised controlled trial.

    Science.gov (United States)

    Chaparro, Camila M; Neufeld, Lynnette M; Tena Alavez, Gilberto; Eguia-Líz Cedillo, Raúl; Dewey, Kathryn G

    2006-06-17

    Delayed clamping of the umbilical cord increases the infant's iron endowment at birth and haemoglobin concentration at 2 months of age. We aimed to assess whether a 2-minute delay in the clamping of the umbilical cord of normal-weight, full-term infants improved iron and haematological status up to 6 months of age. 476 mother-infant pairs were recruited at a large obstetrics hospital in Mexico City, Mexico, randomly assigned to delayed clamping (2 min after delivery of the infant's shoulders) or early clamping (around 10 s after delivery), and followed up until 6 months postpartum. Primary outcomes were infant haematological status and iron status at 6 months of age, and analysis was by intention-to-treat. This study is registered with ClinicalTrials.gov, number NCT00298051. 358 (75%) mother-infant pairs completed the trial. At 6 months of age, infants who had delayed clamping had significantly higher mean corpuscular volume (81.0 fL vs 79.5 fL 95% CI -2.5 to -0.6, p=0.001), ferritin (50.7 mug/L vs 34.4 mug/L 95% CI -30.7 to -1.9, p=0.0002), and total body iron. The effect of delayed clamping was significantly greater for infants born to mothers with low ferritin at delivery, breastfed infants not receiving iron-fortified milk or formula, and infants born with birthweight between 2500 g and 3000 g. A cord clamping delay of 2 minutes increased 6-month iron stores by about 27-47 mg. Delay in cord clamping of 2 minutes could help prevent iron deficiency from developing before 6 months of age, when iron-fortified complementary foods could be introduced.

  9. Cycling Time Trial Performance 4 Hours After Glycogen-Lowering Exercise Is Similarly Enhanced by Recovery Nondairy Chocolate Beverages Versus Chocolate Milk.

    Science.gov (United States)

    Upshaw, Adam U; Wong, Tiffany S; Bandegan, Arash; Lemon, Peter W

    2016-02-01

    Postexercise chocolate milk ingestion has been shown to enhance both glycogen resynthesis and subsequent exercise performance. To assess whether nondairy chocolate beverage ingestion post-glycogen-lowering exercise can enhance 20-km cycling time trial performance 4 hr later, eight healthy trained male cyclists (21.8 ± 2.3y, VO2max = 61.2 ± 1.4 ml·kg-1·min-1; M ± SD) completed a series of intense cycling intervals designed to lower muscle glycogen (Jentjens & Jeukendrup, 2003) followed by 4 hr of recovery and a subsequent 20-km cycling time trial. During the first 2 hr of recovery, participants ingested chocolate dairy milk (DAIRYCHOC), chocolate soy beverage (SOYCHOC), chocolate hemp beverage (HEMPCHOC), low-fat dairy milk (MILK), or a low-energy artificially sweetened, flavored beverage (PLACEBO) at 30-min intervals in a double-blind, counterbalanced repeated-measures design. All drinks, except the PLACEBO (247 kJ) were isoenergetic (2,107 kJ), and all chocolate-flavored drinks provided 1-g CHO·kg body mass-1·h-1. Fluid intake across treatments was equalized (2,262 ± 148 ml) by ingesting appropriate quantities of water based on drink intake. The CHO:PRO ratio was 4:1, 1.5:1, 4:1, and 6:1 for DAIRYCHOC, MILK, SOYCHOC, and HEMPCHOC, respectively. One-way analysis of variance with repeated measures showed time trial performance (DAIRYCHOC = 34.58 ± 2.5 min, SOYCHOC = 34.83 ± 2.2 min, HEMPCHOC = 34.88 ± 1.1 min, MILK = 34.47 ± 1.7 min) was enhanced similarly vs PLACEBO (37.85 ± 2.1) for all treatments (p = .019) These data suggest that postexercise macronutrient and total energy intake are more important for same-day 20-km cycling time trial performance after glycogen-lowering exercise than protein type or protein-to-carbohydrate ratio.

  10. Porcine reproductive and respiratory syndrome virus: Interlaboratory ring trial to evaluate real-time reverse transcription polymerase chain reaction detection methods

    DEFF Research Database (Denmark)

    Wernike, Kerstin; Bonilauri, Paolo; Dauber, Malte

    2012-01-01

    To compare the real-time reverse transcription quantitative polymerase chain reaction (RT-qPCR) assays used for the diagnosis of Porcine reproductive and respiratory syndrome virus (PRRSV), a Europe-wide interlaboratory ring trial was conducted. A variety of PRRSV strains including North American...... (NA) and European (EU) genotype isolates were analyzed by the participants. Great differences regarding qualitative diagnostics as well as analytical sensitivity were observed between the individual RT-qPCR systems, especially when investigating strains from the EU genotype. None of the assays...

  11. Mechanism Study of Port Soft Base Reinforced by Vacuum Preloading%真空预压加固港口软土地基的机理研究

    Institute of Scientific and Technical Information of China (English)

    邵旭

    2015-01-01

    自Kjellman于1952年提出真空预压加固软地基以来,真空预压技术在加固软土地基方面得到广泛应用,但对加固机理仍然有不同的见解。本文结合工程监测资料,对天津某港口软土地基加固区的水势的变化、加固前后总应力变化以及真空卸载之后的地表沉降进行分析,得出负压固结理论可以较好的解释真空预压机理,但对卸压后地表继续沉降这一现象却无法很好解释,这一现象值得进一步探究。%Vacuum preloading reinforcement of soft base has been developed and widely used since the technique was put forward by Kjellman in 1952, but there are still various explanations for the mechanism of reinforcement. Relevant monitoring data was used to analyze the changes of water potential, total stress variation before and after consolidation, and surface settlement after vacuum unloading in a soft base reinforced zone of Tianjin port. The research results showed that negative pressure consolidation theory explained vacuum preloading mechanism well, but the theory did not support the phenomena of surface continuous settlement after unloading, which required further study.

  12. Construction Technologies of Vacuum Preloading Foundation Treatment in Tianjin Port%浅析天津港真空预压法地基处理的主要施工技术

    Institute of Scientific and Technical Information of China (English)

    刘云杰

    2012-01-01

    Based on vacuum preloading soft foundation treatment technologies usually used in Tianjin Port, we emphasize conventional vacuum preloading method and the construction technologies of straight-line vacuum preloading soft foundation treatment, analyze the reason why the expected effect has not been reached in the construction of vacuum preloading soft foundation treatment, propose the detailed resolution and relevant technical measures against the above case, which will provide the reference for similar soft foundation treatment construction.%基于目前天津港常用的真空预压软土地基处理技术,介绍常规真空预压法与直排式真空预压法软土地基处理的施工工艺,着重分析真空预压软土地基处理施工过程中未达预期效果的原因,有针对性地提出解决办法和相应的技术措施,可为类似软土地基处理工程的施工提供参考.

  13. Study status of vacuum preloading soft-soil foundation reinforcing theory and technology%真空预压软土地基加固理论和技术研究现状

    Institute of Scientific and Technical Information of China (English)

    王成保; 苌宽; 张玉国

    2016-01-01

    The paper introduces basic working principles of vacuum preloading method,discusses research status of vacuum preloading soft-soil foundation reinforcing theory and construction technology,analyzes problems existing in vacuum preloading soft-soil foundation construction,and finally points out that:the combination of vacuum preloading technology,monitoring technology and information constructing technology will be good for realizing whole-process construction monitoring,so as to improve social and economic benefits of the project.%介绍了真空预压法的基本工作原理,论述了真空预压软土地基加固理论及施工工艺的研究现状,分析了真空预压软土地基施工中存在的问题,指出将真空预压工艺、监测技术与信息化施工技术相结合,有助于实现施工过程的全面监测,从而提高工程的社会经济效益.

  14. Effect analysis of a soft ground reinforced by a combined vacuum preloading and pneumatic fracturing method%劈裂真空法加固软土地基的效果分析

    Institute of Scientific and Technical Information of China (English)

    章定文; 韩文君; 刘松玉; 杜广印

    2012-01-01

    To overcome the problems of traditional vacuum preloading method, vacuum preloading and pneumatic fracturing are combined to reinforce the performance of ground improvement. The mechanism and construction procedures of the combined method are introduced firstly. The reinforcement effect of the combined method is validated through a pilot highway embankment on soft clay in Jiangsu, China. Comparing to the traditional vacuum preloading method, the combined vacuum preloading and pneumatic fracturing method would enhance the transfer efficiency of vacuum into deep soil layers and accelerate the dissipation of excess pore water pressure. Therefore, the strength increase of soft soil layers improved by the combined method is much larger than that of ground reinforced by the traditional vacuum preloading method. The combined method also can reduce the construction period than the traditional vacuum preloading method. The test results of cone penetration tests and engineering properties tests of soft soils also indicate the superior of the combined vacuum preloading and pneumatic fracturing method.%针对常规真空预压法加固软土地基中存在的问题,介绍了最新研制开发的气压劈裂真空预压法及其施工工艺,并通过现场试验段测试结果分析了劈裂真空法加固软土地基的效果.测试结果表明,较常规真空预压法而言,劈裂真空法可以提高真空荷载向深层土体中的传递效率和加速超静孔隙水压力的消散,既可改善深层软土的加固效果又可加速地基固结,缩短工程工期;劈裂真空法加固地基的沉降效率大于常规真空预压法处理地基,沉降易于收敛,有利于工后沉降的控制.通过加固前后孔压静力触探试验测试结果对比和取样室内试验土性参数变化分析,论证了劈裂真空法加固深层软土地基的有效性和优越性.

  15. Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps in a Medicaid managed care plan: study protocol

    Directory of Open Access Journals (Sweden)

    Ratanawongsa Neda

    2012-01-01

    Full Text Available Abstract Background Health information technology can enhance self-management and quality of life for patients with chronic disease and overcome healthcare barriers for patients with limited English proficiency. After a randomized controlled trial of a multilingual automated telephone self-management support program (ATSM improved patient-centered dimensions of diabetes care in safety net clinics, we collaborated with a nonprofit Medicaid managed care plan to translate research into practice, offering ATSM as a covered benefit and augmenting ATSM to promote medication activation. This paper describes the protocol of the Self-Management Automated and Real-Time Telephonic Support Project (SMARTSteps. Methods/Design This controlled quasi-experimental trial used a wait-list variant of a stepped wedge design to enroll 362 adult health plan members with diabetes who speak English, Cantonese, or Spanish and receive care at 4 publicly-funded clinics. Through language-stratified randomization, participants were assigned to four intervention statuses: SMARTSteps-ONLY, SMARTSteps-PLUS, or wait-list for either intervention. In addition to usual primary care, intervention participants received 27 weekly calls in their preferred language with rotating queries and response-triggered education about self-care, medication adherence, safety concerns, psychological issues, and preventive services. Health coaches from the health plan called patients with out-of-range responses for collaborative goal setting and action planning. SMARTSteps-PLUS also included health coach calls to promote medication activation, adherence and intensification, if triggered by ATSM-reported non-adherence, refill non-adherence from pharmacy claims, or suboptimal cardiometabolic indicators. Wait-list patients crossed-over to SMARTSteps-ONLY or -PLUS at 6 months. For participants who agreed to structured telephone interviews at baseline and 6 months (n = 252, primary outcomes will be

  16. Timing of Antibiotic Prophylaxis in Elective Caesarean Delivery: A Multi-Center Randomized Controlled Trial and Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Chuan Zhang

    Full Text Available To compare the effectiveness of antibiotic prophylaxis before skin incision with that after umbilical cord clamping in elective caesarean delivery.We conducted a randomized open-label controlled trial with two parallel arms at three hospitals in western China. Participants meeting the inclusion criteria received antibiotics 30-60 minutes before skin incision while others received antibiotics after umbilical cords clamping. For the meta-analysis, studies were identified from the database of PUBMED, Cochrane Library and EMbase and assessed using the Cochrane risk of bias tool.Four hundred and ten patients were randomized to receive antibiotics before skin incision (n = 205 or after umbilical cords clamping (n = 205. There was no difference in the incidence of postpartum endometritis (RR = 0.34, 95% CI 0.04 to 3.24, wound infection (RR = 3.06, 95% CI 0.13 to 74.69 and total puerperal morbidity (RR = 1.02, 95% CI 0.47 to 2.22. No increase in the incidence of neonatal sepsis (RR = 0.34, 95% CI 0.04 to 3.24, septic workup (RR = 0.41, 95% CI 0.08 to 2.07, or intermediate NICU admission (RR = 0.73, 95% CI 0.24 to 2.26 was observed. The meta-analysis involving nine RCTs showed that no statistically significant difference was found in terms of the risk of postpartum endometritis (RR = 0.73, 95% CI 0.39, 1.36, wound infection (RR = 0.80, 95%CI 0.55, 1.17, or puerperal morbidity (RR = 0.89, 95% CI 0.70, 1.13. No increase in the incidence of neonatal sepsis (RR = 0.65, 95% CI 0.35 to 1.20, septic workup (RR = 0.88, 95% CI 0.50 to 1.54, or intermediate NICU admission (RR = 0.91, 95% CI 0.70 to 1.18 was observed.For elective caesarean delivery, the effects of antibiotic prophylaxis before skin incision and after umbilical cord clamping were equal. Both antibiotic prophylaxis before skin incision and that after umbilical cord clamping were recommended for elective caesarean delivery. The outcome of further studies should address both maternal and neonatal

  17. CT and MRI-based door-needle-times for acute stroke patients a quasi-randomized clinical trial

    DEFF Research Database (Denmark)

    Hansen, Christine Krarup; Christensen, Anders; Rodgers, Helen

    2017-01-01

    OBJECTIVES: Door-Needle-times (DNT) of 20min are feasible when Computer Tomography (CT) is used for first-line brain-imaging to assess stroke-patients' eligibility for intravenous-tissue-Plasminogen-Activator (iv-tPA), but the more time-consuming Magnetic Resonance Imaging (MRI)-based-evaluation ......OBJECTIVES: Door-Needle-times (DNT) of 20min are feasible when Computer Tomography (CT) is used for first-line brain-imaging to assess stroke-patients' eligibility for intravenous-tissue-Plasminogen-Activator (iv-tPA), but the more time-consuming Magnetic Resonance Imaging (MRI...

  18. On the quantization of time-varying phase synchrony patterns into distinct functional connectivity microstates (FCμstates) in a multi-trial visual ERP paradigm.

    Science.gov (United States)

    Dimitriadis, S I; Laskaris, N A; Tzelepi, A

    2013-07-01

    The analysis of functional brain connectivity has been supported by various techniques encompassing spatiotemporal interactions between distinct areas and enabling the description of network organization. Different brain states are known to be associated with specific connectivity patterns. We introduce here the concept of functional connectivity microstates (FCμstates) as short lasting connectivity patterns resulting from the discretization of temporal variations in connectivity and mediating a parsimonious representation of coordinated activity in the brain. Modifying a well-established framework for mining brain dynamics, we show that a small sized repertoire of FCμstates can be derived so as to encapsulate both the inter-subject and inter-trial response variability and further provide novel insights into cognition. The main practical advantage of our approach lies in the fact that time-varying connectivity analysis can be simplified significantly by considering each FCμstate as prototypical connectivity pattern, and this is achieved without sacrificing the temporal aspects of dynamics. Multi-trial datasets from a visual ERP experiment were employed so as to provide a proof of concept, while phase synchrony was emphasized in the description of connectivity structure. The power of FCμstates in knowledge discovery is demonstrated through the application of network topology descriptors. Their time-evolution and association with event-related responses is explored.

  19. A moderate dose of caffeine ingestion does not change energy expenditure but decreases sleep time in physically active males: a double-blind randomized controlled trial.

    Science.gov (United States)

    Júdice, Pedro B; Magalhães, João P; Santos, Diana A; Matias, Catarina N; Carita, Ana Isabel; Armada-Da-Silva, Paulo A S; Sardinha, Luís B; Silva, Analiza M

    2013-01-01

    Research on the effect of caffeine on energy expenditure (EE), physical activity (PA), and total sleep time (TST) during free-living conditions using objective measures is scarce. We aimed to determine the impact of a moderate dose of caffeine on TST, resting EE (REE), physical activity EE (PAEE), total EE (TEE), and daily time spent in sedentary, light, moderate, and vigorous intensity activities in a 4-day period and the acute effects on heart rate (HR) and EE in physically active males. Using a double-blind crossover trial (ClinicalTrials.gov ID: NCT01477294) with two conditions (4 days each with 3-day washout) randomly ordered as caffeine (5 mg/kg of body mass/day) and placebo (maltodextrin) administered twice per day (2.5 mg/kg), 30 nonsmoker males, low-caffeine users (caffeine intake, while no differences were found between conditions for REE, PAEE, TEE, and PA patterns. Also, no acute effects on HR and EE were found between conditions. Though a large individual variability was observed, our findings revealed no acute or long-term effects of caffeine on EE and PA but decreased TST during free-living conditions in healthy males.

  20. Association of a multibiomarker disease activity score at multiple time-points with radiographic progression in rheumatoid arthritis: results from the SWEFOT trial

    Science.gov (United States)

    Hambardzumyan, Karen; Bolce, Rebecca J; Saevarsdottir, Saedis; Forslind, Kristina; Wallman, Johan K; Cruickshank, Scott E; Sasso, Eric H; Chernoff, David; van Vollenhoven, Ronald F

    2016-01-01

    Objectives In rheumatoid arthritis (RA), predictive biomarkers for subsequent radiographic progression (RP) could improve therapeutic choices for individual patients. We previously showed that the multibiomarker disease activity (MBDA) score in patients with newly diagnosed RA identified patients at risk for RP. We evaluated the MBDA score at multiple time-points as a predictor of RP during 2 years of follow-up. Methods A subset of patients with RA (N=220) from the Swedish Farmacotherapy (SWEFOT) trial were analysed for MBDA score, disease activity score of 28 joints (DAS28), C reactive protein (CRP) and erythrocyte sedimentation rate (ESR) at baseline (BL), month 3 and year 1, for predicting RP based on modified Sharp/van der Heijde scores at BL, year 1 and year 2. Results Patients with persistently low MBDA (44) MBDA scores. Among methotrexate non-responders with a high MBDA score at BL or month 3, significantly more of those who received triple therapy had RP at year 2 compared with those who received antitumour necrosis factor therapy. Conclusions Measuring the MBDA score both before and during treatment in RA was useful for the assessment of individual patient risk for RP during 2 years of follow-up. In comparison with low CRP, ESR or DAS28, a low MBDA score at any time-point was associated with numerically lower proportions of RP. Trial registration number NCT00764725. PMID:26958364

  1. Incorporating prognostic factors into causal estimators: a comparison of methods for randomised controlled trials with a time-to-event outcome.

    Science.gov (United States)

    Hampson, Lisa V; Metcalfe, Chris

    2012-11-20

    In randomised controlled trials, the effect of treatment on those who comply with allocation to active treatment can be estimated by comparing their outcome to those in the comparison group who would have complied with active treatment had they been allocated to it. We compare three estimators of the causal effect of treatment on compliers when this is a parameter in a proportional hazards model and quantify the bias due to omitting baseline prognostic factors. Causal estimates are found directly by maximising a novel partial likelihood; based on a structural proportional hazards model; and based on a 'corrected dataset' derived after fitting a rank-preserving structural failure time model. Where necessary, we extend these methods to incorporate baseline covariates. Comparisons use simulated data and a real data example. Analysing the simulated data, we found that all three methods are accurate when an important covariate was included in the proportional hazards model (maximum bias 5.4%). However, failure to adjust for this prognostic factor meant that causal treatment effects were underestimated (maximum bias 11.4%), because estimators were based on a misspecified marginal proportional hazards model. Analysing the real data example, we found that adjusting causal estimators is important to correct for residual imbalances in prognostic factors present between trial arms after randomisation. Our results show that methods of estimating causal treatment effects for time-to-event outcomes should be extended to incorporate covariates, thus providing an informative compliment to the corresponding intention-to-treat analysis.

  2. Effect of Timing of Tracheotomy on Clinical Outcomes:an Update Meta-analysis Including 11 Trials

    Institute of Scientific and Technical Information of China (English)

    Liang Shan; Rui Zhang; Lian-di Li

    2013-01-01

    Objective To estimate the relative effect of early vs. late tracheotomy on clinical end-points in un-selected intensive care unit (ICU) patients undergoing mechanical ventilation. Methods We searched electronic databases (up to February 27, 2013) for both randomized control trials and observational studies satisfying the predefined inclusion criteria. Results We retrieved 11 reports of studies including a total of 13 705 patients. Early tracheotomy was associated with significant reductions in mortality [33.3% vs. 36.3%; relative risk (RR); 0.92; 95%confidence interval (CI):0.88, 0.97;I2:29%], length of ICU stay (mean difference:−6.55 days;95% CI:−8.19, −4.90; I2: 98%) and duration of mechanical ventilation (mean difference: −6.53 days; 95% CI:−11.43,−1.63;I2:100%). However, as compared with late tracheotomy, early tracheotomy did not reduce the incidence of hospital pneumonia (21.9%vs. 21.0%, RR:0.85;95%CI:0.68, 1.06;I2:67%). Conclusions Early tracheotomy can reduce length of ICU stay, duration of mechanical ventilation and mortality but has no influence on hospital pneumonia when compared with late tracheotomy. Once the decision has been made about tracheotomy, clinical physicians should not hesitate to perform the procedure.

  3. A randomized clinical trial comparing embryo culture in a conventional incubator with a time-lapse incubator

    DEFF Research Database (Denmark)

    Kirkegaard, Kirstine; Hindkjaer, Johnny Juhl; Grøndahl, Marie Louise;

    2012-01-01

    Time-lapse monitoring allows for a flexible embryo evaluation and potentially provides new dynamic markers of embryo competence. Before introducing time-lapse monitoring in a clinical setting, the safety of the instrument must be properly documented. Accordingly, the aim of this study...

  4. The efficacy of motivational counseling and SMS-reminders on daily sitting time in patients with rheumatoid arthritis: protocol for a randomized controlled trial.

    Science.gov (United States)

    Esbensen, Bente Appel; Thomsen, Tanja; Hetland, Merete L; Beyer, Nina; Midtgaard, Julie; Løppenthin, Katrine; Jennum, Poul; Østergaard, Mikkel; Sørensen, Jan; Christensen, Robin; Aadahl, Mette

    2015-01-27

    Patients with RA (Rheumatoid Arthritis) are more sedentary than the general population. Reduction of Sedentary Behaviour (SB) has been suggested as a mean for improvement of health in patients with chronic diseases and mobility problems. Short-term intervention studies have demonstrated that SB can be reduced by behavioural interventions in healthy populations. However, it remains unexplored whether it is valid for patients with RA also. Therefore, the aim of this trial is to investigate the efficacy of an individually tailored, theory-based motivational counseling intervention on reducing daily sitting time in sedentary patients with RA. Additionally, to explore whether a reduction in daily sitting time is associated with reduced pain and fatigue, self-reported physical function, self-efficacy, improved health-related quality of life (HR-QoL) and cardiovascular biomarker levels, and finally to assess the cost-effectiveness of the intervention. For this parallel group randomized trial, 150 patients with RA and at least 5 hours of sitting time per day, will be recruited from a rheumatology outpatient clinic, and block-randomized to the intervention group or the control group receiving usual care. The intervention includes: 1) individual motivational counseling (in total 3 sessions) on reduction of daily sitting time in combination with 2) individual Short Text Message Service (SMS) reminders over a 16-week intervention period. Primary outcome is change in daily sitting time (minutes) from baseline to 16 weeks measured objectively using an ActivPAL® Activity Monitor. Secondary outcomes include fatigue, pain, physical function, HR-QoL, self-efficacy, costs and cost-effectiveness. Furthermore, anthropometric measures will be included as well as measurement of blood pressure and serum lipids. All outcomes are assessed at baseline and repeated after 16 weeks. Follow-up assessments are made at 6 and 18 months post-intervention. The intervention is simple, non

  5. Night-time splinting after fasciectomy or dermo-fasciectomy for Dupuytren's contracture: a pragmatic, multi-centre, randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Larson Debbie

    2011-06-01

    Full Text Available Abstract Background Dupuytren's disease is a progressive fibroproliferative disorder which can result in fixed flexion contractures of digits and impaired hand function. Standard treatment involves surgical release or excision followed by post-operative hand therapy and splinting, however the evidence supporting night splinting is of low quality and equivocal. Methods A multi-centre, pragmatic, open, randomised controlled trial was conducted to evaluate the effect of night splinting on self-reported function, finger extension and satisfaction in patients undergoing fasciectomy or dermofasciectomy. 154 patients from 5 regional hospitals were randomised after surgery to receive hand therapy only (n = 77 or hand therapy with night-splinting (n = 77. Primary outcome was self-reported function using the Disabilities of the Arm, Shoulder and Hand (DASH questionnaire. Secondary outcomes were finger range of motion and patient satisfaction. Primary analysis was by intention to treat. Results 148 (96% patients completed follow-up at 12 months. No statistically significant differences were observed on the DASH questionnaire (0-100 scale: adjusted mean diff. 0.66, 95%CI - 2.79 to 4.11, p = 0.703, total extension deficit of operated digits (degrees: adjusted mean diff 5.11, 95%CI -2.33 to 12.55, p = 0.172 or patient satisfaction (0-10 numerical rating scale: adjusted mean diff -0.35, 95%CI -1.04 to 0.34, p = 0.315 at 1 year post surgery. Similarly, in a secondary per protocol analysis no statistically significant differences were observed between the groups in any of the outcomes. Conclusions No differences were observed in self-reported upper limb disability or active range of motion between a group of patients who were all routinely splinted after surgery and a group of patients receiving hand therapy and only splinted if and when contractures occurred. Given the added expense of therapists' time, thermoplastic materials and the potential inconvenience to

  6. The effectiveness of sit-stand workstations for changing office workers' sitting time: results from the Stand@Work randomized controlled trial pilot.

    Science.gov (United States)

    Chau, Josephine Y; Daley, Michelle; Dunn, Scott; Srinivasan, Anu; Do, Anna; Bauman, Adrian E; van der Ploeg, Hidde P

    2014-10-08

    Prolonged sitting time is detrimental for health. Individuals with desk-based occupations tend to sit a great deal and sit-stand workstations have been identified as a potential strategy to reduce sitting time. Hence, the objective of the current study was to examine the effects of using sit-stand workstations on office workers' sitting time at work and over the whole day. We conducted a randomized controlled trial pilot with crossover design and waiting list control in Sydney, Australia from September 2011 to July 2012 (n = 42; 86% female; mean age 38 ± 11 years). Participants used a sit-stand workstation for four weeks in the intervention condition. In the time-matched control condition, participants received nothing and crossed over to the intervention condition after four weeks. The primary outcomes, sitting, standing and walking time at work, were assessed before and after using the workstations with ActivPALs and self-report questionnaires. Secondary outcomes, domain-specific sitting over the whole day, were assessed by self-report. Linear mixed models estimated changes in outcomes adjusting for measurement time, study grouping and covariates. Intervention participants significantly reduced objectively assessed time spent sitting at work by 73 min/workday (95% CI: -106,-39) and increased standing time at work by 65 min/workday (95% CI: 47, 83); these changes were significant relative to controls (p = 0.004 and p sitting time significantly declined in intervention participants (-80 min/workday; 95% CI: -155, -4). This study shows that introducing sit-stand workstations in the office can reduce desk-based workers' sitting time at work in the short term. Larger scale studies on more representative samples are needed to determine the public health impact of sit-stand workstations. ACTRN12612000072819.

  7. 吹填土真空预压工程中孔压计改进埋设方法的研究%Improvement of Laying Pore Water Pressure Gauge for Vacuum Preloading of Dredger Fill

    Institute of Scientific and Technical Information of China (English)

    徐永辉; 汤明礼; 俞炯奇; 王文双

    2014-01-01

    This paper introduced two laying methods of pore water pressure gauge for vacuum preloading of dredger fill , i . e . traditional method of laying by drilling and an improved one of laying by spile machine , and compared monitoring data of the two methods . Results show that the gauge laid by spile machine will produce excess pore water pressure and the dissipation time of this pressure at deep measuring points is longer than that of pressure gauge laid by drilling . For pore water pressure gauge at shallow levels , using spile machine is convenient and cost -effective;while for pore water pressure gauge below 15m , traditional method of laying by drilling should be adopted .%介绍了吹填土真空预压工程中孔隙水压力计(以下简称“孔压计”)的传统钻孔埋设方法和改进埋设方法-插板机埋设,对使用改进埋设方法的监测数据进行了分析,并与钻孔埋设方法的监测数据进行比较。分析表明,采用插板机埋设的孔压计中产生明显超静孔隙水压力,且深部测点超静孔隙水压力消散所需时间较钻孔埋设的长;对于浅层深度的孔压计可采用插板机埋设,节省施工成本,方便快捷,而超过15 m深度的孔压计埋设则需采用常规钻孔。

  8. Does point of care prothrombin time measurement reduce the transfusion of fresh frozen plasma in patients undergoing major surgery? The POC-OP randomized-controlled trial

    Directory of Open Access Journals (Sweden)

    Alberio Lorenzo

    2009-11-01

    Full Text Available Abstract Background Bleeding is a frequent complication during surgery. The intraoperative administration of blood products, including packed red blood cells, platelets and fresh frozen plasma (FFP, is often live saving. Complications of blood transfusions contribute considerably to perioperative costs and blood product resources are limited. Consequently, strategies to optimize the decision to transfuse are needed. Bleeding during surgery is a dynamic process and may result in major blood loss and coagulopathy due to dilution and consumption. The indication for transfusion should be based on reliable coagulation studies. While hemoglobin levels and platelet counts are available within 15 minutes, standard coagulation studies require one hour. Therefore, the decision to administer FFP has to be made in the absence of any data. Point of care testing of prothrombin time ensures that one major parameter of coagulation is available in the operation theatre within minutes. It is fast, easy to perform, inexpensive and may enable physicians to rationally determine the need for FFP. Methods/Design The objective of the POC-OP trial is to determine the effectiveness of point of care prothrombin time testing to reduce the administration of FFP. It is a patient and assessor blind, single center randomized controlled parallel group trial in 220 patients aged between 18 and 90 years undergoing major surgery (any type, except cardiac surgery and liver transplantation with an estimated blood loss during surgery exceeding 20% of the calculated total blood volume or a requirement of FFP according to the judgment of the physicians in charge. Patients are randomized to usual care plus point of care prothrombin time testing or usual care alone without point of care testing. The primary outcome is the relative risk to receive any FFP perioperatively. The inclusion of 110 patients per group will yield more than 80% power to detect a clinically relevant relative risk

  9. Randomized trial of time-limited interruptions of protease inhibitor-based antiretroviral therapy (ART vs. continuous therapy for HIV-1 infection.

    Directory of Open Access Journals (Sweden)

    Cynthia Firnhaber

    Full Text Available BACKGROUND: The clinical outcomes of short interruptions of PI-based ART regimens remains undefined. METHODS: A 2-arm non-inferiority trial was conducted on 53 HIV-1 infected South African participants with viral load 450 cells/µl on stavudine (or zidovudine, lamivudine and lopinavir/ritonavir. Subjects were randomized to a sequential 2, 4 and 8-week ART interruptions or b continuous ART (cART. Primary analysis was based on the proportion of CD4 count >350 cells(c/ml over 72 weeks. Adherence, HIV-1 drug resistance, and CD4 count rise over time were analyzed as secondary endpoints. RESULTS: The proportions of CD4 counts >350 cells/µl were 82.12% for the intermittent arm and 93.73 for the cART arm; the difference of 11.95% was above the defined 10% threshold for non-inferiority (upper limit of 97.5% CI, 24.1%; 2-sided CI: -0.16, 23.1. No clinically significant differences in opportunistic infections, adverse events, adherence or viral resistance were noted; after randomization, long-term CD4 rise was observed only in the cART arm. CONCLUSION: We are unable to conclude that short PI-based ART interruptions are non-inferior to cART in retention of immune reconstitution; however, short interruptions did not lead to a greater rate of resistance mutations or adverse events than cART suggesting that this regimen may be more forgiving than NNRTIs if interruptions in therapy occur. TRIAL REGISTRATION: ClinicalTrials.gov NCT00100646.

  10. The Seated Inactivity Trial (SIT): Physical Activity and Dietary Outcomes Associated With 8 Weeks of Imposed Sedentary Time.

    Science.gov (United States)

    Cull, Brooke J; Haub, Mark D; Rosenkranz, Richard R; Lawler, Thomas; Rosenkranz, Sara K

    2016-03-01

    Sedentary time is an independent risk factor for chronic diseases and mortality. It is unknown whether active adults alter their dietary and/or physical activity behaviors in response to imposed sedentary time, possibly modifying risk. The aim of this study was to determine whether imposed sedentary time would alter typical behaviors of active adults. Sixteen physically active, young adults were randomized to the no-intervention control (CON, n = 8) group or the sedentary-intervention (SIT, n = 8) group. SIT participants attended monitored sedentary sessions (8 wk, 10 h/wk). Assessments including diet and physical activity occurred at baseline, week 4, and week 9. There were no differences (P > .05) between CON and SIT groups for step counts or time spent in sedentary, light, moderate, or vigorous physical activity when comparing a week during imposed sedentary time (week 4) to baseline and week 9. At week 4, caloric intake was not different from baseline (P > .05) in either group. Caloric intake decreased significantly (P > .05) in SIT from baseline to week 9. Active adults did not alter physical activity or dietary behaviors during the imposed sedentary intervention. However, SIT reduced caloric intake from baseline to week 9, indicating a possible compensatory response to imposed sitting in active adults.

  11. A Randomized Controlled Pilot Trial Investigating the Impact of a Workplace Resilience Program During a Time of Significant Organizational Change.

    Science.gov (United States)

    Rogerson, Shane; Meir, Rudi; Crowley-McHattan, Zac; McEwen, Kathryn; Pastoors, Rachel

    2016-04-01

    The aim of this study was to investigate the effectiveness of a short-term resilience intervention as measured by the Resilience at Work (RAW) scale. A 5-week resilience program was implemented with 28 volunteers and assessed by the 20-item RAW scale. The scale was administered electronically and participants were match paired into either a treatment or control group. Statistical analysis was conducted using a 2 × 2 group (Treatment, control) × time (pre, post) analysis of variance with repeated measures. Postintervention time point RAW total score was significantly greater in the treatment group (P < 0.01) and statistical significance was also achieved for four of the seven subscales. Employee resilience can be improved via specific educational and skills training requiring a total time commitment of just 5 hours, making this intervention feasible for most working environments.

  12. Collaborative trial validation studies of real-time PCR-based GMO screening methods for detection of the bar gene and the ctp2-cp4epsps construct.

    Science.gov (United States)

    Grohmann, Lutz; Brünen-Nieweler, Claudia; Nemeth, Anne; Waiblinger, Hans-Ulrich

    2009-10-14

    Polymerase Chain Reaction (PCR)-based screening methods targeting genetic elements commonly used in genetically modified (GM) plants are important tools for the detection of GM materials in food, feed, and seed samples. To expand and harmonize the screening capability of enforcement laboratories, the German Federal Office of Consumer Protection and Food Safety conducted collaborative trials for interlaboratory validation of real-time PCR methods for detection of the phosphinothricin acetyltransferase (bar) gene from Streptomyces hygroscopicus and a construct containing the 5-enolpyruvylshikimate-3-phosphate synthase gene from Agrobacterium tumefaciens sp. strain CP4 (ctp2-cp4epsps), respectively. To assess the limit of detection, precision, and accuracy of the methods, laboratories had to analyze two sets of 18 coded genomic DNA samples of events LLRice62 and MS8 with the bar method and NK603 and GT73 with the ctp2-cp4epsps method at analyte levels of 0, 0.02, and 0.1% GM content, respectively. In addition, standard DNAs were provided to the laboratories to generate calibration curves for copy number quantification of the bar and ctp2-cp4epsps target sequences present in the test samples. The study design and the results obtained are discussed with respect to the difficult issue of developing general guidelines and concepts for the collaborative trial validation of qualitative PCR screening methods.

  13. The P600-as-P3 hypothesis revisited: single-trial analyses reveal that the late EEG positivity following linguistically deviant material is reaction time aligned.

    Science.gov (United States)

    Sassenhagen, Jona; Schlesewsky, Matthias; Bornkessel-Schlesewsky, Ina

    2014-10-01

    The P600, a late positive ERP component following linguistically deviant stimuli, is commonly seen as indexing structural, high-level processes, e.g. of linguistic (re)analysis. It has also been identified with the P3 (P600-as-P3 hypothesis), which is thought to reflect a systemic neuromodulator release facilitating behavioural shifts and is usually response time aligned. We investigated single-trial alignment of the P600 to response, a critical prediction of the P600-as-P3 hypothesis. Participants heard sentences containing morphosyntactic and semantic violations and responded via a button press. The elicited P600 was perfectly response aligned, while an N400 following semantic deviations was stimulus aligned. This is, to our knowledge, the first single-trial analysis of language processing data using within-sentence behavioural responses as temporal covariates. Results support the P600-as-P3 perspective and thus constitute a step towards a neurophysiological grounding of language-related ERPs.

  14. Social Problem Solving and Depressive Symptoms Over Time: A Randomized Clinical Trial of Cognitive Behavioral Analysis System of Psychotherapy, Brief Supportive Psychotherapy, and Pharmacotherapy

    Science.gov (United States)

    Klein, Daniel N.; Leon, Andrew C.; Li, Chunshan; D’Zurilla, Thomas J.; Black, Sarah R.; Vivian, Dina; Dowling, Frank; Arnow, Bruce A.; Manber, Rachel; Markowitz, John C.; Kocsis, James H.

    2011-01-01

    Objective Depression is associated with poor social problem-solving, and psychotherapies that focus on problem-solving skills are efficacious in treating depression. We examined the associations between treatment, social problem solving, and depression in a randomized clinical trial testing the efficacy of psychotherapy augmentation for chronically depressed patients who failed to fully respond to an initial trial of pharmacotherapy (Kocsis et al., 2009). Method Participants with chronic depression (n = 491) received Cognitive Behavioral Analysis System of Psychotherapy (CBASP), which emphasizes interpersonal problem-solving, plus medication; Brief Supportive Psychotherapy (BSP) plus medication; or medication alone for 12 weeks. Results CBASP plus pharmacotherapy was associated with significantly greater improvement in social problem solving than BSP plus pharmacotherapy, and a trend for greater improvement in problem solving than pharmacotherapy alone. In addition, change in social problem solving predicted subsequent change in depressive symptoms over time. However, the magnitude of the associations between changes in social problem solving and subsequent depressive symptoms did not differ across treatment conditions. Conclusions It does not appear that improved social problem solving is a mechanism that uniquely distinguishes CBASP from other treatment approaches. PMID:21500885

  15. Porcine reproductive and respiratory syndrome virus: interlaboratory ring trial to evaluate real-time reverse transcription polymerase chain reaction detection methods.

    Science.gov (United States)

    Wernike, Kerstin; Bonilauri, Paolo; Dauber, Malte; Errington, Jane; LeBlanc, Neil; Revilla-Fernández, Sandra; Hjulsager, Charlotte; Isaksson, Mats; Stadejek, Tomasz; Beer, Martin; Hoffmann, Bernd

    2012-09-01

    To compare the real-time reverse transcription quantitative polymerase chain reaction (RT-qPCR) assays used for the diagnosis of Porcine reproductive and respiratory syndrome virus (PRRSV), a Europe-wide interlaboratory ring trial was conducted. A variety of PRRSV strains including North American (NA) and European (EU) genotype isolates were analyzed by the participants. Great differences regarding qualitative diagnostics as well as analytical sensitivity were observed between the individual RT-qPCR systems, especially when investigating strains from the EU genotype. None of the assays or commercial kits used in the ring trial could identify all different PRRSV strains with an optimal analytical and diagnostic sensitivity. The genetic variability of the PRRSV strains, which is supposed to hinder the diagnostic of the RT-PCR because of mutations at the primer binding sites, was also confirmed by sequencing and subsequent phylogenetic analysis. In summary, a major problem in PRRSV diagnostics by RT-qPCR is false-negative results. To achieve maximum safety in the molecular diagnosis of PRRSV, the combined usage of different assays or kits is highly recommended.

  16. A randomized control trial to increase return behavior of first-time donors using implementation intention and commitment techniques

    NARCIS (Netherlands)

    Wevers, A.; Wigboldus, D.H.J.; Baaren, R.B. van; Veldhuizen, I.J.T.

    2013-01-01

    Background: For blood establishments it is important that blood donors donate blood for a longer period of time. Unfortunately, many donors stop donating blood in the beginning of their donor career. It is therefore desirable that donors are well informed about, and agree with the blood donation inv

  17. The effects of modified exponential tapering technique on perceived exertion, heart rate, time trial performance, VO2max and power output among highly trained junior cyclists.

    Science.gov (United States)

    Ishak, Asmadi; Hashim, Hairul A; Krasilshchikov, Oleksandr

    2016-09-01

    The present study investigated the effects of a 2-week modified exponential taper on physiological adaptation and time trial performance among junior cyclists. Participants (N.=27) with the mean age of 16.95±0.8 years, height of 165.6±6.1 cm and weight of 54.19±8.1 kg were matched into either modified exponential taper (N.=7), normal exponential taper (N.=7), or control (N.=7) groups using their initial VO2max values. Both experimental groups followed a 12-week progressive endurance training program and subsequently, a 2-week tapering phase. A simulated 20-km time trial performance along with VO2max, power output, heart rate and rating of perceived exertion were measured at baseline, pre and post-taper. One way ANOVA was used to analyze the difference between groups before the start of the intervention while mixed factorial ANOVA was used to analyze the difference between groups across measurement sessions. When homogeneity assumption was violated, the Greenhouse-Geisser Value was used for the corrected values of the degrees of freedom for the within subject factor the analysis. Significant interactions between experimental groups and testing sessions were found in VO2max (F=6.67, df=4, P<0.05), power output (F=5.02, df=4, P<0.05), heart rate (F=10.87, df=2.51, P<0.05) rating of perceived exertion (F=13.04, df=4, P<0.05) and 20KM time trial (F=4.64, df=2.63, P<0.05). Post-hoc analysis revealed that both types of taper exhibited positive effects compared to the non-taper condition in the measured performance markers at post-taper while no different were found between the two taper groups. It was concluded that both taper protocols successfully inducing physiological adaptations among the junior cyclists by reducing the volume and maintaining the intensity of training.

  18. Elasto-viscoplastic model and its application to settlement calculation of soft foundation by preloading treatment%弹黏塑性模型及其在预压处理软基沉降计算中的应用

    Institute of Scientific and Technical Information of China (English)

    扈胜霞; 陈育民; 闫竹玲

    2014-01-01

    In order to obtain an accurate calculation of settlement after construction of soft soil foundation by vacuum preloading, surcharge preloading and vacuum combined surcharge preloading method, stress changes of soft foundation reinforced by the different preloading method is analyzed. Elasto-viscoplastic model which the specific stress path of change is weakened represents stress-strain relation of soft clay. Combined with classical Biot consolidation theory, the finite element method of calculation the settlement of the soft clay improved by preloading method is deduced. The proposed method is verified through the concrete example. The outcomes as follows: (1) Reinforcement mechanism and stress paths are not the same for the different preloading methods. Surcharge preloading method is an anisotropic consolidation process under positive pressure. Vacuum preloading method is the isotropic consolidation process under negative pressure. (2) elasto-viscoplastic model is a rheological model not affected either by transient stress or the specific influence of stress paths. It have superiority when applied it to the soft foundation reinforced by the different preloading method that neither need to consider stress paths nor need to consider the primary and secondary consolidation division. (3) In the Biot consolidation theory, using the elasto-viscoplastic model to reflect the physical equations of soft soil, consolidation settlement and settlement after construction of soft foundation could be accurately calculated. (4) The vertical displacement of soft soils is influenced obviously by viscosity parameter/V and plasticity parameter/V of elasto-viscoplastic model.%以准确计算预压荷载作用下软土路基的工后沉降为目的,分析了不同预压法加固软土地基时土体的应力变化。提出了用弱化应力路径变化过程的弹黏塑性模型表示软黏土的应力-应变关系。结合经典比奥固结理论,推导了预压荷载作用

  19. Indicators of early and late processing reveal the importance of within-trial-time for theories of associative learning.

    Directory of Open Access Journals (Sweden)

    Harald Lachnit

    Full Text Available In four human learning experiments (Pavlovian skin conductance, causal learning, speeded classification task, we evaluated several associative learning theories that assume either an elemental (modified unique cue model and Harris' model or a configural (Pearce's configural theory and an extension of it form of stimulus processing. The experiments used two modified patterning problems (A/B/C+, AB/BC/AC+ vs. ABC-; A+, BC+ vs. ABC-. Pearce's configural theory successfully predicted all of our data reflecting early stimulus processing, while the predictions of the elemental theories were in accord with all of our data reflecting later stages of stimulus processing. Our results suggest that the form of stimulus representation depends on the amount of time available for stimulus processing. Our findings highlight the necessity to investigate stimulus processing during conditioning on a finer time scale than usually done in contemporary research.

  20. Real-time differential GPS/GLONASS trials in Europe using all-in-view 20-channel receivers

    Science.gov (United States)

    Capaccio, S.; Lowe, D.; Walsh, D. M. A.; Daly, P.

    Following the initial development of 20-channel, all-in-view Global Navigation Satellite System (GNSS), GPS/GLONASS/Inmarsat-3, receivers at the Institute of Satellite Navigation (ISN), University of Leeds, a modification programme has been undertaken to allow real-time differential corrections to be sent from one 20-channel receiver to another identical receiver using a serial link between them. The differential correction software incorporates the RTCM SC-104 and RTCA DO-217 format developed specifically for GPS and adjusted by the ISN to allow simultaneous GLONASS operation.After successful laboratory testing, real-time differential GNSS tests were successfully completed in static mode between Aberdeen and Leeds via the SkyFix differential data-link, and in dynamic mode at DTEO Boscombe Down using a C-band data-link between the ground and a receiver on board the DRA BAC 1-11 aircraft. The aims of the tests were, (i) to demonstrate real-time differential GNSS position-fixing, (ii) to establish the accuracy improvements brought about, and (iii) to examine the effects of data-link latency and satellite PDOP on the solution accuracy.

  1. Organizational-Level Strategies With or Without an Activity Tracker to Reduce Office Workers' Sitting Time: Rationale and Study Design of a Pilot Cluster-Randomized Trial.

    Science.gov (United States)

    Brakenridge, Charlotte L; Fjeldsoe, Brianna S; Young, Duncan C; Winkler, Elisabeth A H; Dunstan, David W; Straker, Leon M; Brakenridge, Christian J; Healy, Genevieve N

    2016-05-25

    The office workplace is a key setting in which to address excessive sitting time and inadequate physical activity. One major influence on workplace sitting is the organizational environment. However, the impact of organizational-level strategies on individual level activity change is unknown. Further, the emergence of sophisticated, consumer-targeted wearable activity trackers that facilitate real-time self-monitoring of activity, may be a useful adjunct to support organizational-level strategies, but to date have received little evaluation in this workplace setting. The aim of this study is to evaluate the feasibility, acceptability, and effectiveness of organizational-level strategies with or without an activity tracker on sitting, standing, and stepping in office workers in the short (3 months, primary aim) and long-term (12 months, secondary aim). This study is a pilot, cluster-randomized trial (with work teams as the unit of clustering) of two interventions in office workers: organizational-level support strategies (eg, visible management support, emails) or organizational-level strategies plus the use of a waist-worn activity tracker (the LUMOback) that enables self-monitoring of sitting, standing, and stepping time and enables users to set sitting and posture alerts. The key intervention message is to 'Stand Up, Sit Less, and Move More.' Intervention elements will be implemented from within the organization by the Head of Workplace Wellbeing. Participants will be recruited via email and enrolled face-to-face. Assessments will occur at baseline, 3, and 12 months. Time spent sitting, sitting in prolonged (≥30 minute) bouts, standing, and stepping during work hours and across the day will be measured with activPAL3 activity monitors (7 days, 24 hours/day protocol), with total sitting time and sitting time during work hours the primary outcomes. Web-based questionnaires, LUMOback recorded data, telephone interviews, and focus groups will measure the

  2. Fibrin sealant does not decrease seroma output or time to drain removal following inguino-femoral lymph node dissection in melanoma patients: A randomized controlled trial (NCT00506311

    Directory of Open Access Journals (Sweden)

    Mansfield Paul F

    2008-06-01

    Full Text Available Abstract Background This study assessed the impact of closed suction drains and evaluated whether the intraoperative use of a fibrin sealant decreased time to drain removal and wound complications in melanoma patients undergoing inguino-femoral lymph node dissection. Methods A pilot study (n = 18 assessed the impact of a closed suction drain following inguino-femoral lymph node dissection. A single-institution, prospective trial was then performed in which patients were randomized to a group that received intraoperative application of a fibrin sealant following inguino-femoral lymph node dissection or to a control group that did not receive sealant. Results The majority of the patients enrolled felt the drains caused moderate or severe discomfort and difficulties with activities of daily living. Thirty patients were then randomized; the median time to drain removal in the control group (n = 14 was 30 days (range, 13–74 compared to 29 days (range, 11–45 in the fibrin sealant group (n = 16; P = 0.6. Major and minor complications were similar in the two groups. Conclusion Postoperative closed suction drains were associated with major patient inconvenience. Applying a fibrin sealant at the time of inguino-femoral lymph node dissection in melanoma patients did not reduce the time to drain removal or postoperative morbidity. Alternative strategies are needed.

  3. The Effect of Timing and Frequency of Push Notifications on Usage of a Smartphone-Based Stress Management Intervention: An Exploratory Trial

    Science.gov (United States)

    Hargood, Charlie; Pejovic, Veljko; Geraghty, Adam W. A.; Lloyd, Scott; Goodman, Natalie; Michaelides, Danius T.; Weston, Anna; Musolesi, Mirco; Weal, Mark J.; Yardley, Lucy

    2017-01-01

    Push notifications offer a promising strategy for enhancing engagement with smartphone-based health interventions. Intelligent sensor-driven machine learning models may improve the timeliness of notifications by adapting delivery to a user’s current context (e.g. location). This exploratory mixed-methods study examined the potential impact of timing and frequency on notification response and usage of Healthy Mind, a smartphone-based stress management intervention. 77 participants were randomised to use one of three versions of Healthy Mind that provided: intelligent notifications; daily notifications within pre-defined time frames; or occasional notifications within pre-defined time frames. Notification response and Healthy Mind usage were automatically recorded. Telephone interviews explored participants’ experiences of using Healthy Mind. Participants in the intelligent and daily conditions viewed (d = .47, .44 respectively) and actioned (d = .50, .43 respectively) more notifications compared to the occasional group. Notification group had no meaningful effects on percentage of notifications viewed or usage of Healthy Mind. No meaningful differences were indicated between the intelligent and non-intelligent groups. Our findings suggest that frequent notifications may encourage greater exposure to intervention content without deterring engagement, but adaptive tailoring of notification timing does not always enhance their use. Hypotheses generated from this study require testing in future work. Trial registration number: ISRCTN67177737 PMID:28046034

  4. The effect of education and supervised exercise vs. education alone on the time to total hip replacement in patients with severe hip osteoarthritis. A randomized clinical trial protocol

    DEFF Research Database (Denmark)

    Jensen, Carsten; Roos, Ewa M.; Kjærsgaard-Andersen, Per

    2013-01-01

    measures are the five subscales of the Hip disability and Osteoarthritis Outcome Score, physical activity (UCLA activity score), and patient’s global perceived effect. Other measures include pain after exercise, joint-specific adverse events, exercise adherence, general health status (EQ-5D-5L), mechanical...... muscle function and performance in physical tests. A cost-effectiveness analysis will also be performed. Discussion: To our knowledge, this is the first randomized clinical trial comparing a patient education plus supervised exercise program to patient education alone in hip osteoarthritis patients...... replacement is considered. We hypothesize that the time to hip replacement can be postponed in patients with severe hip osteoarthritis following participation in a patient education and supervised exercise program when compared to patients receiving patient education alone. Methods/design: A prospective...

  5. International ring trial for the validation of an event-specific Golden Rice 2 quantitative real-time polymerase chain reaction method.

    Science.gov (United States)

    Jacchia, Sara; Nardini, Elena; Bassani, Niccolò; Savini, Christian; Shim, Jung-Hyun; Trijatmiko, Kurniawan; Kreysa, Joachim; Mazzara, Marco

    2015-05-27

    This article describes the international validation of the quantitative real-time polymerase chain reaction (PCR) detection method for Golden Rice 2. The method consists of a taxon-specific assay amplifying a fragment of rice Phospholipase D α2 gene, and an event-specific assay designed on the 3' junction between transgenic insert and plant DNA. We validated the two assays independently, with absolute quantification, and in combination, with relative quantification, on DNA samples prepared in haploid genome equivalents. We assessed trueness, precision, efficiency, and linearity of the two assays, and the results demonstrate that both the assays independently assessed and the entire method fulfill European and international requirements for methods for genetically modified organism (GMO) testing, within the dynamic range tested. The homogeneity of the results of the collaborative trial between Europe and Asia is a good indicator of the robustness of the method.

  6. Comparative analysis of international standards for the fatigue testing of posterior spinal fixation systems: the importance of preload in ISO 12189.

    Science.gov (United States)

    La Barbera, Luigi; Ottardi, Claudia; Villa, Tomaso

    2015-10-01

    compared with the previous model where the precompression was not considered. Neglecting the initial preload due to the assembly of the overall construct according to ISO 12189 standard could lead to an overestimation of the stress on the rods up to 50%. To correctly describe the state of stress on the posterior spinal fixator, tested according to the ISO procedure, it is important to take into account the initial preload due to the assembly of the overall construct. Copyright © 2015 Elsevier Inc. All rights reserved.

  7. Exploring time- and frequency- dependent functional connectivity and brain networks during deception with single-trial event-related potentials

    Science.gov (United States)

    Gao, Jun-Feng; Yang, Yong; Huang, Wen-Tao; Lin, Pan; Ge, Sheng; Zheng, Hong-Mei; Gu, Ling-Yun; Zhou, Hui; Li, Chen-Hong; Rao, Ni-Ni

    2016-11-01

    To better characterize the cognitive processes and mechanisms that are associated with deception, wavelet coherence was employed to evaluate functional connectivity between different brain regions. Two groups of subjects were evaluated for this purpose: 32 participants were required to either tell the truth or to lie when facing certain stimuli, and their electroencephalogram signals on 12 electrodes were recorded. The experimental results revealed that deceptive responses elicited greater connectivity strength than truthful responses, particularly in the θ band on specific electrode pairs primarily involving connections between the prefrontal/frontal and central regions and between the prefrontal/frontal and left parietal regions. These results indicate that these brain regions play an important role in executing lying responses. Additionally, three time- and frequency-dependent functional connectivity networks were proposed to thoroughly reflect the functional coupling of brain regions that occurs during lying. Furthermore, the wavelet coherence values for the connections shown in the networks were extracted as features for support vector machine training. High classification accuracy suggested that the proposed network effectively characterized differences in functional connectivity between the two groups of subjects over a specific time-frequency area and hence could be a sensitive measurement for identifying deception.

  8. To determine block establishment time of supraclavicular brachial plexus block using blunt versus short bevel needle: A prospective randomized trial

    Directory of Open Access Journals (Sweden)

    V Ahuja

    2016-01-01

    Full Text Available Background: Unintentional intraneural injection under ultrasound guidance (USG with fine caliber needles and lower success rate with large caliber Tuohy needles in supraclavicular brachial plexus block (SCB have been reported. Materials and Methods: We undertook study to standardize the use of 20-gauge short versus blunt bevel needle for SCB. After approval of Institutional Ethics Committee and written informed consent, patients were randomized using computer-generated random number table to either of the two groups; blunt bevel needle group (n = 30: SCB under USG using 20-gauge Tuohy needle or short bevel needle group (n = 30: SCB under USG using 20-gauge short bevel needle. The primary outcome of the study was time to establishment of sensory and motor block of individual nerves, and secondary outcome was tolerability and any adverse effects. Results: The time to establishment of sensory and motor block in individual nerve territory was similar in both the groups. The complete sensory and motor anesthesia was achieved in 78.3% patients and complete sensory and motor anesthesia after supplementary block was achieved in 86.6% patients. Paresthesias during SCB were recorded in 15 patients. Out of these eight patients were of blunt bevel group and seven patients were of short bevel group. None of the patients experienced any neurological adverse effects. Conclusion: The establishment of sensory and motor blockade of individual nerves was similar to 20-gauge short and blunt bevel needle under ultrasound guide with no neurological adverse events.

  9. Patient navigation and time to diagnostic resolution: results for a cluster randomized trial evaluating the efficacy of patient navigation among patients with breast cancer screening abnormalities, Tampa, FL.

    Directory of Open Access Journals (Sweden)

    Ji-Hyun Lee

    Full Text Available The objective of this study was to evaluate a patient navigation (PN program that attempts to reduce the time between a breast cancer screening abnormality and definitive diagnosis among medically underserved populations of Tampa Bay, Florida.The Moffitt Patient Navigation Research Program conducted a cluster randomized design with 10 primary care clinics. Patients were navigated from time of a breast screening abnormality to diagnostic resolution. This paper examined the length of time between breast abnormality and definitive diagnosis, using a shared frailty Cox proportional hazard model to assess PN program effect.1,039 patients were eligible for the study because of an abnormal breast cancer screening/clinical abnormality (494 navigated; 545 control. Analysis of PN effect by two time periods of resolution (0-3 months and > 3 months showed a lagged effect of PN. For patients resolving in the first three months, the adjusted Hazard Ratio (aHR was 0.85 (95% Confidence Interval [CI]: 0.64-1.13 suggesting that PN had no effect on resolution time during this period. Beyond three months, however, navigated patients resolved more quickly to diagnostic resolution compared with the control group (aHR 2.8, 95%CI: 1.30-6.13. The predicted aHR at 3 months was 1.2, which was not statistically significant, while PN had a significant positive effect beyond 4.7 months.PN programs may increase the timeliness of diagnostic resolution for patients with a breast cancer-related abnormality. PN did not speed diagnostic resolution during the initial three months of follow up but started to reduce time to diagnostic resolution after three months and showed a significant effect after 4.7 months.ClinicalTrials.gov NCT00375024.

  10. Association between full breastfeeding, timing of complementary food introduction, and iron status in infancy in Germany: results of a secondary analysis of a randomized trial.

    Science.gov (United States)

    Libuda, Lars; Hilbig, Annett; Berber-Al-Tawil, Seda; Kalhoff, Hermann; Kersting, Mathilde

    2016-10-24

    Considering the low content in breast milk breastfed infants might be at particular risk for depleted iron stores after the first months of life. This study evaluates the association of the mode of milk feeding and the timing of complementary food (CF) introduction with parameters of iron status in term healthy infants in Germany. In this secondary analysis of a randomized controlled trial, parents recorded all foods consumed by their infants from the age of 8 weeks onwards. Mothers were advised on the German food-based dietary guidelines for infants. Accordingly, CF was introduced between the fifth and seventh month of age. Blood samples were taken at 4 and at 10 months of age for analyses of iron status parameters. Iron depletion was defined as serum ferritin feeding or the timing of CF introduction. At this age, the iron depletion prevalence was >34% without general differences according to the mode of milk feeding or the timing of CF introduction. The high prevalence of depleted iron stores observed in both breastfed and formula-fed infants illustrates the need for further studies to improve our understanding of the optimal iron intake and sensitive parameters of iron status in infancy.

  11. A clinical trial comparing parenteral oxytetracyline and enrofloxacin on time to recovery in sheep lame with acute or chronic footrot in Kashmir, India

    Directory of Open Access Journals (Sweden)

    Kaler J

    2012-01-01

    Full Text Available Abstract Background No clinical trials have been conducted in India on the efficacy of parenteral antibacterials to treat footrot in sheep. In addition, there are no studies worldwide on the efficacy of parenteral antibacterials to treat chronic footrot. Sixty two sheep with acute footrot and 30 sheep with chronic footrot from 7 villages in Kashmir, India were recruited into two separate trials. Sheep with acute footrot were allocated to one of three treatments using stratified random sampling: long acting parenteral oxytetracycline, long acting parenteral enrofloxacin and topical application of potassium permanganate solution (a traditional treatment used by sheep farmers in India. In a quasi pre-post intervention design, sheep with chronic footrot that had not responded to treatment with potassium permanaganate were randomly allocated to treatment with one of the two parenteral antibacterials mentioned above. Sheep with acute footrot were treated on day 0 and those with chronic footrot on days 0, 3, 6 and 9. Sheep were monitored for up to 28 days after treatment. Time to recovery from lameness and initial healing of lesions was assessed using Kaplan-Meier survival curves, nonparametric log-rank and Wilcoxon sign-rank tests. Results There was significant correlation in recovery from lameness and presence of healing lesions in sheep with acute (r = 0.94 or chronic (r = 0.98 footrot. Sheep with acute footrot which were treated with parenteral antibacterials had a significantly more rapid recovery from lameness and had healing lesions (median = 7 days compared with those treated with topical potassium permanganate solution (less than 50% recovered in 28 days. The median time to recovery in sheep with chronic footrot treated with either antibacterial was 17 days; this was significantly lower than the median of 75 days lame before treatment with antibacterials. The median time to recovery for both acute and chronic footrot increased as the severity

  12. The effect of time, temperature and storage device on umbilical cord blood gas and lactate measurement: a randomized controlled trial.

    Science.gov (United States)

    White, Christopher R H; Mok, Tabitha; Doherty, Dorota A; Henderson, Jennifer J; Newnham, John P; Pennell, Craig E

    2012-06-01

    Umbilical cord blood gas analysis has a significant and growing role in early neonatal assessment. Factors often delay analysis of cord blood allowing values to change. Consequently, this study evaluates the impact of time, temperature and method of storage on umbilical blood gas and lactate analyses. Umbilical cord segments from 80 singleton deliveries were randomized to: cords at room temperature (CR), cords stored on ice (CI), syringes at room temperature (SR) or syringes stored on ice (SI). Analysis occurred every 15 minutes for one-hour. Mixed model analysis of variance allowing for repeated measures was utilized. Cord arterial pH deteriorated in CR, CI, and SI within 15 minutes (p ≤ 0.001), with SR stable until 60 minutes (p = 0.002). Arterial pCO(2) remained stable in SR and CI, increased in SI (p = 0.002; 45 minutes) and decreased in CR (p blood gas values change rapidly after delivery. Smallest changes were seen in SR group. Data suggest that analyses should be conducted as soon as possible after delivery.

  13. Timing and pattern of postexercise protein ingestion affects whole-body protein balance in healthy children: a randomized trial.

    Science.gov (United States)

    Volterman, Kimberly A; Moore, Daniel R; Breithaupt, Peter; Grathwohl, Dominik; Offord, Elizabeth A; Karagounis, Leonidas G; Timmons, Brian W

    2017-07-06

    The dose and timing of postexercise protein ingestion can influence whole-body protein balance (WBPB) in adults, although comparable data from children are scarce. This study investigated how protein intake (both amount and distribution) postexercise can affect WBPB in physically active children. Thirty-five children (26 males; 9-13 years old) underwent a 5-day adaptation diet, maintaining a protein intake of 0.95 g·kg(-1)·day(-1). Participants consumed [(15)N]glycine (2 mg·kg(-1)) before performing 3 × 20 min of variable-intensity cycling, and whole-body protein kinetics were assessed over 6 and 24 h of recovery. Fifteen grams of protein was distributed across 2 isoenergetic carbohydrate-containing beverages (15 and 240 min postexercise) containing reciprocal amounts of protein (i.e., 0 + 15 g, 5 + 10 g, 10 + 5 g, and 15 + 0 g for Groups A-D, respectively). Over the 6 h that included the exercise bout and consumption of the first beverage at 15 min postexercise, WBPB (i.e., synthesis - breakdown) demonstrated a linear increase of 0.647 g·kg(-1)·day(-1) per 1 g protein intake (P parabola (P < 0.05), suggesting that a maximum in WBPB was achieved between groups B and C. In conclusion, despite a dose response early in recovery, a periodized protein intake with multiple smaller doses after physical activity may be more beneficial than a single bolus dose in promoting daily WBPB in healthy active children.

  14. The central role of vascular extracellular matrix and basement membrane remodeling in metabolic syndrome and type 2 diabetes: the matrix preloaded

    Directory of Open Access Journals (Sweden)

    Tyagi Suresh C

    2005-06-01

    Full Text Available Abstract The vascular endothelial basement membrane and extra cellular matrix is a compilation of different macromolecules organized by physical entanglements, opposing ionic charges, chemical covalent bonding, and cross-linking into a biomechanically active polymer. These matrices provide a gel-like form and scaffolding structure with regional tensile strength provided by collagens, elasticity by elastins, adhesiveness by structural glycoproteins, compressibility by proteoglycans – hyaluronans, and communicability by a family of integrins, which exchanges information between cells and between cells and the extracellular matrix of vascular tissues. Each component of the extracellular matrix and specifically the capillary basement membrane possesses unique structural properties and interactions with one another, which determine the separate and combined roles in the multiple diabetic complications or diabetic opathies. Metabolic syndrome, prediabetes, type 2 diabetes mellitus, and their parallel companion (atheroscleropathy are associated with multiple metabolic toxicities and chronic injurious stimuli. The adaptable quality of a matrix or form genetically preloaded with the necessary information to communicate and respond to an ever-changing environment, which supports the interstitium, capillary and arterial vessel wall is individually examined.

  15. Tai chi qigong as a means to improve night-time sleep quality among older adults with cognitive impairment: a pilot randomized controlled trial

    Science.gov (United States)

    Chan, Aileen WK; Yu, Doris SF; Choi, KC; Lee, Diana TF; Sit, Janet WH; Chan, Helen YL

    2016-01-01

    Purpose Age-related cognitivee decline is a growing public health concern worldwide. More than a quarter of adults with cognitive impairment experience sleep disturbance. The objective of this pilot study was to evaluate the preliminary effects of tai chi qigong (TCQ) on improving the night-time sleep quality of older adults with cognitive impairment. Participants Older adults with cognitive impairment who complain of sleep disturbance. Methods A randomized controlled trial with two groups. Fifty-two subjects were recruited from two district elderly community centers and randomly assigned to either the TCQ group (n=27) or the control group (n=25). The intervention group received TCQ training consisting of two 60-minute sessions each week for 2 months. The control group was advised to maintain their usual activities. Sleep quality was measured by the Chinese Pittsburgh Sleep Quality Index. Quality of life was measured by Short-form 12, cognitive functions measured by mini-mental state examination, and subjective memory deficits measured by the memory inventory for Chinese. Results Data were collected at baseline, 2 months, and 6 months. Significant results were noted at 6 months in the Chinese Pittsburgh Sleep Quality Index global score (P=0.004), sleep duration (P=0.003), habitual sleep efficiency (P=0.002), and the Short-form 12 mental health component (P<0.001). The TCQ participants reported better sleep quality and a better (quality of life) mental health component than the control group. Conclusion TCQ can be considered a useful nonpharmacological approach for improving sleep quality in older adults with cognitive impairment. Clinical trial registration CUHK_CCT00448 (https://www2.ccrb.cuhk.edu.hk/registry/public/287). PMID:27698557

  16. Reanalyses of the historical series of UK variety trials to quantify the contributions of genetic and environmental factors to trends and variability in yield over time.

    Science.gov (United States)

    Mackay, I; Horwell, A; Garner, J; White, J; McKee, J; Philpott, H

    2011-01-01

    Historical datasets have much to offer. We analyse data from winter wheat, spring and winter barley, oil seed rape, sugar beet and forage maize from the UK National List and Recommended List trials over the period 1948-2007. We find that since 1982, for the cereal crops and oil seed rape, at least 88% of the improvement in yield is attributable to genetic improvement, with little evidence that changes in agronomy have improved yields. In contrast, in the same time period, plant breeding and changes in agronomy have contributed almost equally to increased yields of forage maize and sugar beet. For the cereals prior to 1982, contributions from plant breeding were 42, 60 and 86% for winter barley, winter wheat and spring barley, respectively. These results demonstrate the overwhelming importance of plant breeding in increasing crop productivity in the UK. Winter wheat data are analysed in more detail to exemplify the use of historical data series to study and detect disease resistance breakdown, sensitivity of varieties to climatic factors, and also to test methods of genomic selection. We show that breakdown of disease resistance can cause biased estimates of variety and year effects, but that comparison of results between fungicide treated and untreated trials over years may be a means to screen for durable resistance. We find the greatest sensitivities of the winter wheat germplasm to seasonal differences in rainfall and temperature are to summer rainfall and winter temperature. Finally, for genomic selection, correlations between observed and predicted yield ranged from 0.17 to 0.83. The high correlation resulted from markers predicting kinship amongst lines rather than tagging multiple QTL. We believe the full value of these data will come from exploiting links with other experiments and experimental populations. However, not to exploit such valuable historical datasets is wasteful.

  17. Improved cortisol exposure-time profile and outcome in patients with adrenal insufficiency: a prospective randomized trial of a novel hydrocortisone dual-release formulation.

    Science.gov (United States)

    Johannsson, G; Nilsson, A G; Bergthorsdottir, R; Burman, P; Dahlqvist, P; Ekman, B; Engström, B E; Olsson, T; Ragnarsson, O; Ryberg, M; Wahlberg, J; Biller, B M K; Monson, J P; Stewart, P M; Lennernäs, H; Skrtic, S

    2012-02-01

    Patients with treated adrenal insufficiency (AI) have increased morbidity and mortality rate. Our goal was to improve outcome by developing a once-daily (OD) oral hydrocortisone dual-release tablet with a more physiological exposure-time cortisol profile. The aim was to compare pharmacokinetics and metabolic outcome between OD and the same daily dose of thrice-daily (TID) dose of conventional hydrocortisone tablets. We conducted an open, randomized, two-period, 12-wk crossover multicenter trial with a 24-wk extension at five university hospital centers. The trial enrolled 64 adults with primary AI; 11 had concomitant diabetes mellitus (DM). The same daily dose of hydrocortisone was administered as OD dual-release or TID. We evaluated cortisol pharmacokinetics. Compared with conventional TID, OD provided a sustained serum cortisol profile 0-4 h after the morning intake and reduced the late afternoon and the 24-h cortisol exposure. The mean weight (difference = -0.7 kg, P = 0.005), systolic blood pressure (difference = -5.5 mm Hg, P = 0.0001) and diastolic blood pressure (difference: -2.3 mm Hg; P = 0.03), and glycated hemoglobin (absolute difference = -0.1%, P = 0.0006) were all reduced after OD compared with TID at 12 wk. Compared with TID, a reduction in glycated hemoglobin by 0.6% was observed in patients with concomitant DM during OD (P = 0.004). The OD dual-release tablet provided a more circadian-based serum cortisol profile. Reduced body weight, reduced blood pressure, and improved glucose metabolism were observed during OD treatment. In particular, glucose metabolism improved in patients with concomitant DM.

  18. Improved VO2max and time trial performance with more high aerobic intensity interval training and reduced training volume: a case study on an elite national cyclist.

    Science.gov (United States)

    Støren, Øyvind; Bratland-Sanda, Solfrid; Haave, Marius; Helgerud, Jan

    2012-10-01

    The present study investigated to what extent more high aerobic intensity interval training (HAIT) and reduced training volume would influence maximal oxygen uptake (VO2max) and time trial (TT) performance in an elite national cyclist in the preseason period. The cyclist was tested for VO2max, cycling economy (C(c)), and TT performance on an ergometer cycle during 1 year. Training was continuously logged using heart rate monitor during the entire period. Total monthly training volume was reduced in the 2011 preseason compared with the 2010 preseason, and 2 HAIT blocks (14 sessions in 9 days and 15 sessions in 10 days) were performed as running. Between the HAIT blocks, 3 HAIT sessions per week were performed as cycling. From November 2010 to February 2011, the cyclist reduced total average monthly training volume by 18% and cycling training volume by 60%. The amount of training at 90-95% HRpeak increased by 41%. VO2max increased by 10.3% on ergometer cycle. TT performance improved by 14.9%. C(c) did not change. In conclusion, preseason reduced total training volume but increased amount of HAIT improved VO2max and TT performance without any changes in C(c). These improvements on cycling appeared despite that the HAIT blocks were performed as running. Reduced training time, and training transfer from running into improved cycling form, may be beneficial for cyclists living in cold climate areas.

  19. Pre-Exercise Hyperhydration-Induced Bodyweight Gain Does Not Alter Prolonged Treadmill Running Time-Trial Performance in Warm Ambient Conditions

    Science.gov (United States)

    Gigou, Pierre-Yves; Dion, Tommy; Asselin, Audrey; Berrigan, Felix; Goulet, Eric D. B.

    2012-01-01

    This study compared the effect of pre-exercise hyperhydration (PEH) and pre-exercise euhydration (PEE) upon treadmill running time-trial (TT) performance in the heat. Six highly trained runners or triathletes underwent two 18 km TT runs (~28 °C, 25%–30% RH) on a motorized treadmill, in a randomized, crossover fashion, while being euhydrated or after hyperhydration with 26 mL/kg bodyweight (BW) of a 130 mmol/L sodium solution. Subjects then ran four successive 4.5 km blocks alternating between 2.5 km at 1% and 2 km at 6% gradient, while drinking a total of 7 mL/kg BW of a 6% sports drink solution (Gatorade, USA). PEH increased BW by 1.00 ± 0.34 kg (P Running TT time did not differ between groups (PEH: 85.6 ± 11.6 min; PEE: 85.3 ± 9.6 min, P = 0.82). Heart rate (5 ± 1 beats/min) and rectal (0.3 ± 0.1 °C) and body (0.2 ± 0.1 °C) temperatures of PEE were higher than those of PEH (P running TT performance under warm conditions in highly-trained runners drinking ~500 mL sports drink during exercise. PMID:23016126

  20. Sub-Nyquist Field Trial Using Time Frequency Packed DP-QPSK Super-Channel Within Fixed ITU-T Grid

    CERN Document Server

    Potì, L; Berrettini, G; Fresi, F; Foggi, T; Secondini, M; Giorgi, L; Cavaliere, F; Hackett, S; Petronio, A; Nibbs, P; Forgan, R; Leong, A; Masciulli, R; Pfander, C

    2015-01-01

    Sub-Nyquist time frequency packing technique was demonstrated for the first time in a super channel field trial transmission over long-haul distances. The technique allows a limited spectral occupancy even with low order modulation formats. The transmission was successfully performed on a deployed Australian link between Sydney and Melbourne which included 995 km of uncompensated SMF with coexistent traffic. 40 and 100 Gb/s co-propagating channels were transmitted together with the super-channel in a 50 GHz ITU-T grid without additional penalty. The super-channel consisted of eight sub-channels with low-level modulation format, i.e. DP-QPSK, guaranteeing better OSNR robustness and reduced complexity with respect to higher order formats. At the receiver side, coherent detection was used together with iterative maximum-a-posteriori (MAP) detection and decoding. A 975 Gb/s DP-QPSK super-channel was successfully transmitted between Sydney and Melbourne within four 50GHz WSS channels (200 GHz). A maximum potential...

  1. Sub-Nyquist field trial using time frequency packed DP-QPSK super-channel within fixed ITU-T grid.

    Science.gov (United States)

    Potì, L; Meloni, G; Berrettini, G; Fresi, F; Foggi, T; Secondini, M; Giorgi, L; Cavaliere, F; Hackett, S; Petronio, A; Nibbs, P; Forgan, R; Leong, A; Masciulli, R; Pfander, C

    2015-06-15

    Sub-Nyquist time frequency packing technique was demonstrated for the first time in a super-channel field trial transmission over long-haul distances. The technique allows a limited spectral occupancy even with low order modulation formats. The transmission was successfully performed on a deployed Australian link between Sydney and Melbourne which included 995 km of uncompensated SMF with coexistent traffic. 40 and 100 Gb/s co-propagating channels were transmitted together with the super-channel in a 50 GHz ITU-T grid without additional penalty. The super-channel consisted of eight sub-channels with low-level modulation format, i.e. DP-QPSK, guaranteeing better OSNR robustness and reduced complexity with respect to higher order formats. At the receiver side, coherent detection was used together with iterative maximum-a-posteriori (MAP) detection and decoding. A 975 Gb/s DP-QPSK super-channel was successfully transmitted between Sydney and Melbourne within four 50GHz WSS channels (200 GHz). A maximum potential SE of 5.58 bit/s/Hz was achieved with an OSNR = 15.8 dB, comparable to the OSNR of the installed 100 Gb/s channels. The system reliability was proven through long term measurements. In addition, by closing the link in a loop back configuration, a potential SE∙d product of 9254 bit/s/Hz·km was achieved.

  2. The efficacy of motivational counselling and SMS reminders on daily sitting time in patients with rheumatoid arthritis: a randomised controlled trial.

    Science.gov (United States)

    Thomsen, Tanja; Aadahl, Mette; Beyer, Nina; Hetland, Merete Lund; Løppenthin, Katrine; Midtgaard, Julie; Christensen, Robin; Østergaard, Mikkel; Jennum, Poul Jørgen; Esbensen, Bente Appel

    2017-09-01

    The aim of this report is to investigate the efficacy of an individually tailored, theory-based behavioural intervention for reducing daily sitting time, pain and fatigue, as well as improving health-related quality of life, general self-efficacy, physical function and cardiometabolic biomarkers in patients with rheumatoid arthritis (RA). In this randomised controlled trial 150 patients with RA were randomised to an intervention or a no-intervention control group. The intervention group received three individual motivational counselling sessions and short message service or text messages aimed at reduction of sedentary behaviour during the 16-week intervention period. Primary outcome was change in daily sitting time measured objectively by ActivPAL. Secondary outcomes included change in pain, fatigue, physical function, general self-efficacy, quality of life, blood pressure, blood lipids, haemoglobin A1c, body weight, body mass index, waist circumference and waist-hip ratio. 75 patients were allocated to each group. Mean reduction in daily sitting time was -1.61 hours/day in the intervention versus 0.59 hours/day increase in the control group between-group difference -2.20 (95% CI -2.72 to -1.69; p<0.0001) hours/day in favour of the intervention group. Most of the secondary outcomes were also in favour of the intervention. An individually tailored, behavioural intervention reduced daily sitting time in patients with RA and improved patient-reported outcomes and cholesterol levels. NCT01969604; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  3. Impairment of 40-km time-trial performance but not peak power output with external iliac kinking: a case study in a world-class cyclist.

    Science.gov (United States)

    Lamberts, Robert P; Mann, T N; Rietjens, Gerard J; Tijdink, Hendrik H

    2014-07-01

    Iliac blood-flow restrictions causing painful and "powerless" legs are often attributed to overtraining and may develop for some time before being correctly diagnosed. In the current study, differences between actual performance parameters and performance parameters predicted from the Lamberts and Lambert Submaximal Cycle Test (LSCT) were studied in a world-class cyclist with bilateral kinking of the external iliac artery before and after surgery. Two performance-testing sessions, including a peak-power-output (PPO) test and a 40-km time trial (TT) were conducted before surgery, while 1 testing session was conducted after the surgery. Actual vs LSCT-predicted performance parameters in the world-class cyclists were compared with 82 symptom-free trained to elite male cyclists. No differences were found between actual and LSCT-predicted PPO before and after surgical intervention. However, there were differences between actual and LSCT-predicted 40-km TT time in the tests performed before the surgery (2:51and 2:55 min:s, respectively). These differences were no longer apparent in the postsurgery 40-km TT (2 s). This finding suggests that iliac blood-flow restrictions seem to mainly impair endurance performance rather than peak cycling performance. A standard PPO test without brachial ankle blood-pressure measurements might not be able to reflect iliac blood-flow restrictions. Differences between actual and LSCT-predicted 40-km TT time may assist in earlier referral to a cardiovascular specialist and result in earlier detection of iliac blood-flow restrictions.

  4. Solutions for Groundwater Level in Effected Zone of Soft Ground Under Vacuum Preloading%真空预压影响区地下水位变化的计算

    Institute of Scientific and Technical Information of China (English)

    张仪萍; 李剑; 严露

    2011-01-01

    The analytical solution for ground water level changes in affected zone of soft ground with vacuum preloading was investigated by using one-dimensional unsteady seepage flow model. Using average groundwater zero pressure line in reinforced zone as the boundary condintion, solution of one-dimensional unsteady seepage flow model was conducted when reducation of water pressure in drainage boundary was changing over time. An example of the calculation based on the analyticalsolution was given to analyze the influence of permeability coefficient in affected zone and drainage rate in reinforcement area on groundwater level in affected zone. The results show that it is necessary to use unsteady seepage flow model to analysis soft clay that permeability is low and the permeability of soil in affected zone was the main factor to influene groundwater level outside reinforcement area. Drainage flow rate in reinforcement area only influence the time from unsteady seepage flow to steady flow but had less impact on flow range.%基于渗流理论,采用一维非稳定渗流模型,阐述了边界为变水头条件下的真空预压影响区地下水位变化的解析方法.利用加固区平均地下水零压线作为边界条件,推导了排水边界上降深随时间变化的一维非稳定渗流,得出影响区土体中地下水位的变化规律.通过算例,分析了影响区渗透系数以及预压区排水速率等因素对影响区地下水位的影响.结果表明,对于渗透性较低的软黏土而言,采用非稳定渗流分析是必要的,影响区渗透系数是区外地下水位变化的主要因素.预压区排水速率只影响区外渗流趋于稳定的时间,对渗流范围的影响较小.

  5. Evaluation of time, attendance of medical staff and resources for radiotherapy in pediatric and adolescent patients. The DEGRO-QUIRO trial

    Energy Technology Data Exchange (ETDEWEB)

    Zabel-du Bois, Angelika; Milker-Zabel, Stefanie; Debus, Juergen [University of Heidelberg, Department of Radiotherapy and RadioOncology, Heidelberg (Germany); Bruns, Frank; Christiansen, Hans [Medical School Hannover, Department of Radiation Oncology, Hannover (Germany); Ernst, Iris; Willich, Normann [University of Muenster, Department of Radiation Oncology, Muenster (Germany); Popp, Wolfgang [Prime Networks AG, Basel (Switzerland); Sack, Horst [University of Essen, Department of Radiation Oncology, Essen (Germany)

    2014-06-15

    The German Society of Radiation Oncology (DEGRO) initiated a multicenter trial to develop and evaluate adequate modules to assert core procedures in radiotherapy. The aim of this prospective evaluation was to methodical assess the required resources for radiotherapy in pediatric and adolescent patients. At three radiotherapy centers of excellence (University Hospitals of Heidelberg and Muenster, the Medical School of Hannover), the manpower and time required for radiotherapy in pediatric and adolescent patients was prospectively documented consistently over a 2-year period. The data were collected using specifically developed standard forms and were evaluated using specific process analysis tools. A total number of 1914 data sets were documented and carefully analyzed. The personnel time requirements for all occupational groups were calculated as total time needed for a specific procedure and mean time per person. Regarding radiotherapy in general anesthesia, the required manpower was higher. The personnel time requirements in these cases were also longer, mainly due to longer room occupancy. Overall, the required resources were remarkably similar between the three different departments and may, therefore, be considered as representative. For the first time, the personnel time requirements of a radiotherapy department for the maintenance, protection, and optimization of operational readiness for radiotherapy in pediatric and adolescent patients with and without general anesthesia were determined methodically. (orig.) [German] Die deutsche Gesellschaft fuer Radioonkologie (DEGRO) initiierte eine Multizenterstudie zur Entwicklung und Anwendung geeigneter Module zur Erhebung und Analyse von Kernprozessen bei der Radiotherapie von Kindern und Jugendlichen. Ziel dieser prospektiven Erhebung war es, die erforderlichen Ressourcen bei der Radiotherapie im Kindesalter systematisch zu evaluieren. An drei strahlentherapeutischen Kompetenzzentren (Universitaetskliniken

  6. Leisure-time physical activity, sedentary behaviors, sleep, and cardiometabolic risk factors at baseline in the PREDIMED-PLUS intervention trial: A cross-sectional analysis

    Science.gov (United States)

    Rosique-Esteban, Nuria; Díaz-López, Andrés; Martínez-González, Miguel A.; Corella, Dolores; Goday, Albert; Martínez, J. Alfredo; Romaguera, Dora; Vioque, Jesus; Arós, Fernando; Garcia-Rios, Antonio; Tinahones, Francisco; Estruch, Ramon; Fernández-García, José Carlos; Lapetra, José; Serra-Majem, Luís; Pinto, Xavier; Tur, Josep A.; Bueno-Cavanillas, Aurora; Vidal, Josep; Delgado-Rodríguez, Miguel; Daimiel, Lidia; Vázquez, Clotilde; Rubio, Miguel Ángel; Ros, Emilio; Salas-Salvadó, Jordi

    2017-01-01

    Limited data exists on the interrelationships between physical activity (PA), sedentary behaviors and sleep concerning cardiometabolic risk factors in aged adults at high cardiovascular disease risk. Our aim was to examine independent and joint associations between time spent in leisure-time PA, sedentary behaviors and sleep on the prevalence of obesity, type 2 diabetes (T2D) and components of the metabolic syndrome (MetS) in Mediterranean individuals at high cardiovascular risk. Cross-sectional analyses were performed on baseline data from 5776 Spanish adults (aged 55-75y in men; 60-75y in women) with overweight/obesity and MetS, from October 2013 to October 2016, in the PREDIMED-PLUS trial. Employing multivariable-adjusted Cox regression with robust variance and constant time (given the cross-sectional design), higher prevalence of obesity, T2D and abdominal obesity as component of the MetS were associated with greater time in TV-viewing (Relative Risk, RR: 1.02, 95%CI: 1.01, 1.03; RR:1.04, 95%CI: 1.02, 1.06 and RR: 1.01 95%CI: 1.00, 1.02; respectively, all P < .01). Conversely, greater time in moderate-vigorous PA (MVPA) was associated with lower prevalence of obesity, T2D, abdominal obesity and low HDL-cholesterol (RR: 0.95, 95%CI: 0.93, 0.97; RR: 0.94, 95%CI: 0.89, 0.99; RR: 0.97, 95%CI: 0.96, 0.98; and RR: 0.95, 95%CI: 0.91, 0.99, respectively, all P < .05). For these outcomes, theoretically substituting 1-h/day of MVPA for 1-h/day TV-viewing was also significantly associated with lower prevalence (RR 0.91 to 0.97, all P < .05). Similar lower RR in these outcomes was observed when substituting 1-h/day of MVPA for 1-h/day of sleeping. Longer time watching TV and not meeting MVPA recommendations were jointly associated with higher RR of the prevalence of obesity and T2D. We concluded that, in senior individuals at high cardiovascular risk, greater time spent on MVPA and fewer on sedentary behaviors was inversely associated with prevalence of obesity, T2D, and

  7. [Night-time premedication with Di-potassium-clorazepate, diazepam or a placebo before anaesthesia; a double-blind trial (author' transl)].

    Science.gov (United States)

    Skubella, U; Henschel, W F; Franzke, H G

    1981-12-01

    The efficacy of dipotassium clorazepate (DPCA) and of diazepam (DP) as night-time premedication was tested against a placebo in a double-blind trial in 300 patients of all ages. Examination of the patients in the morning before anaesthesia showed that tachycardia, nausea and anxiety were considerably less in patients who had been premedicated with DPCA or DP. Relief from anxiety and restlessness according to standardized self-evaluation scale was most marked in the DPCA group. There were statistically significant differences between the groups with respect to the sleep pattern: 66 per cent of patients in the DPCA group fell asleep within the normal time of 2-15 minutes compared with 53 per cent in the DP group and 48 per cent in the placebo group. Uninterrupted sleep until the morning was experienced by about 70 per cent of patients who had been premedicated with DPCA as against 47 per cent and 31 per cent who had been given DP or a placebo respectively. The total sleeping period was normal or slightly prolonged in 73 and 74 per cent of patients who had received one or the other drug but in only 38 per cent of patients in the placebo group. As regarded the quality of sleep (quiet, uninterrupted sleep and feeling rested) the DPCA group considered it to have been much sounder than did the other groups. On account of its marked ataractic and sleep-protecting properties DPCA is considered to be the most suitable agent for night-time premedication.

  8. Does the timed up and go test predict future falls among British community-dwelling older people? Prospective cohort study nested within a randomised controlled trial.

    Science.gov (United States)

    Kojima, Gotaro; Masud, Tahir; Kendrick, Denise; Morris, Richard; Gawler, Sheena; Treml, Jonathan; Iliffe, Steve

    2015-04-03

    Falling is common among older people. The Timed-Up-and-Go Test (TUG) is recommended as a screening tool for falls but its predictive value has been challenged. The objectives of this study were to examine the ability of TUG to predict future falls and to estimate the optimal cut-off point to identify those with higher risk for future falls. This is a prospective cohort study nested within a randomised controlled trial including 259 British community-dwelling older people ≥65 years undergoing usual care. TUG was measured at baseline. Prospective diaries captured falls over 24 weeks. A Receiver Operating Characteristic curve analysis determined the optimal cut-off point to classify future falls risk with sensitivity, specificity, and predictive values of TUG times. Logistic regression models examined future falls risk by TUG time. Sixty participants (23%) fell during the 24 weeks. The area under the curve was 0.58 (95% confidence interval (95% CI) = 0.49-0.67, p = 0.06), suggesting limited predictive value. The optimal cut-off point was 12.6 seconds and the corresponding sensitivity, specificity, and positive and negative predictive values were 30.5%, 89.5%, 46.2%, and 81.4%. Logistic regression models showed each second increase in TUG time (adjusted for age, gender, comorbidities, medications and past history of two falls) was significantly associated with future falls (adjusted odds ratio (OR) = 1.09, 95% CI = 1.00-1.19, p = 0.05). A TUG time ≥12.6 seconds (adjusted OR = 3.94, 95% CI = 1.69-9.21, p = 0.002) was significantly associated with future falls, after the same adjustments. TUG times were significantly and independently associated with future falls. The ability of TUG to predict future falls was limited but with high specificity and negative predictive value. TUG may be most useful in ruling in those with a high risk of falling rather than as a primary measure in the ascertainment of risk.

  9. An efficient large-scale retroviral transduction method involving preloading the vector into a RetroNectin-coated bag with low-temperature shaking.

    Science.gov (United States)

    Dodo, Katsuyuki; Chono, Hideto; Saito, Naoki; Tanaka, Yoshinori; Tahara, Kenichi; Nukaya, Ikuei; Mineno, Junichi

    2014-01-01

    In retroviral vector-mediated gene transfer, transduction efficiency can be hampered by inhibitory molecules derived from the culture fluid of virus producer cell lines. To remove these inhibitory molecules to enable better gene transduction, we had previously developed a transduction method using a fibronectin fragment-coated vessel (i.e., the RetroNectin-bound virus transduction method). In the present study, we developed a method that combined RetroNectin-bound virus transduction with low-temperature shaking and applied this method in manufacturing autologous retroviral-engineered T cells for adoptive transfer gene therapy in a large-scale closed system. Retroviral vector was preloaded into a RetroNectin-coated bag and incubated at 4°C for 16 h on a reciprocating shaker at 50 rounds per minute. After the supernatant was removed, activated T cells were added to the bag. The bag transduction method has the advantage of increasing transduction efficiency, as simply flipping over the bag during gene transduction facilitates more efficient utilization of the retroviral vector adsorbed on the top and bottom surfaces of the bag. Finally, we performed validation runs of endoribonuclease MazF-modified CD4(+) T cell manufacturing for HIV-1 gene therapy and T cell receptor-modified T cell manufacturing for MAGE-A4 antigen-expressing cancer gene therapy and achieved over 200-fold (≥ 10(10)) and 100-fold (≥ 5 × 10(9)) expansion, respectively. In conclusion, we demonstrated that the large-scale closed transduction system is highly efficient for retroviral vector-based T cell manufacturing for adoptive transfer gene therapy, and this technology is expected to be amenable to automation and improve current clinical gene therapy protocols.

  10. An efficient large-scale retroviral transduction method involving preloading the vector into a RetroNectin-coated bag with low-temperature shaking.

    Directory of Open Access Journals (Sweden)

    Katsuyuki Dodo

    Full Text Available In retroviral vector-mediated gene transfer, transduction efficiency can be hampered by inhibitory molecules derived from the culture fluid of virus producer cell lines. To remove these inhibitory molecules to enable better gene transduction, we had previously developed a transduction method using a fibronectin fragment-coated vessel (i.e., the RetroNectin-bound virus transduction method. In the present study, we developed a method that combined RetroNectin-bound virus transduction with low-temperature shaking and applied this method in manufacturing autologous retroviral-engineered T cells for adoptive transfer gene therapy in a large-scale closed system. Retroviral vector was preloaded into a RetroNectin-coated bag and incubated at 4°C for 16 h on a reciprocating shaker at 50 rounds per minute. After the supernatant was removed, activated T cells were added to the bag. The bag transduction method has the advantage of increasing transduction efficiency, as simply flipping over the bag during gene transduction facilitates more efficient utilization of the retroviral vector adsorbed on the top and bottom surfaces of the bag. Finally, we performed validation runs of endoribonuclease MazF-modified CD4(+ T cell manufacturing for HIV-1 gene therapy and T cell receptor-modified T cell manufacturing for MAGE-A4 antigen-expressing cancer gene therapy and achieved over 200-fold (≥ 10(10 and 100-fold (≥ 5 × 10(9 expansion, respectively. In conclusion, we demonstrated that the large-scale closed transduction system is highly efficient for retroviral vector-based T cell manufacturing for adoptive transfer gene therapy, and this technology is expected to be amenable to automation and improve current clinical gene therapy protocols.

  11. Tai chi qigong as a means to improve night-time sleep quality among older adults with cognitive impairment: a pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Chan AWK

    2016-09-01

    Full Text Available Aileen WK Chan, Doris SF Yu, KC Choi, Diana TF Lee, Janet WH Sit, Helen YL Chan The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong SAR, People’s Republic of China Purpose: Age-related cognitive decline is a growing public health concern worldwide. More than a quarter of adults with cognitive impairment experience sleep disturbance. The objective of this pilot study was to evaluate the preliminary effects of tai chi qigong (TCQ on improving the night-time sleep quality of older adults with cognitive impairment. Participants: Older adults with cognitive impairment who complain of sleep disturbance. Methods: A randomized controlled trial with two groups. Fifty-two subjects were recruited from two district elderly community centers and randomly assigned to either the TCQ group (n=27 or the control group (n=25. The intervention group received TCQ training consisting of two 60-minute sessions each week for 2 months. The control group was advised to maintain their usual activities. Sleep quality was measured by the Chinese Pittsburgh Sleep Quality Index. Quality of life was measured by Short-form 12, cognitive functions measured by mini-mental state examination, and subjective memory deficits measured by the memory inventory for Chinese. Results: Data were collected at baseline, 2 months, and 6 months. Significant results were noted at 6 months in the Chinese Pittsburgh Sleep Quality Index global score (P=0.004, sleep duration (P=0.003, habitual sleep efficiency (P=0.002, and the Short-form 12 mental health component (P<0.001. The TCQ participants reported better sleep quality and a better (quality of life mental health component than the control group. Conclusion: TCQ can be considered a useful nonpharmacological approach for improving sleep quality in older adults with cognitive impairment.Clinical trial registration: CUHK_CCT00448 (https://www2.ccrb.cuhk.edu.hk/registry/public/287. Keywords: cognitive decline, mind

  12. V-TIME: a treadmill training program augmented by virtual reality to decrease fall risk in older adults: study design of a randomized controlled trial.

    Science.gov (United States)

    Mirelman, Anat; Rochester, Lynn; Reelick, Miriam; Nieuwhof, Freek; Pelosin, Elisa; Abbruzzese, Giovanni; Dockx, Kim; Nieuwboer, Alice; Hausdorff, Jeffrey M

    2013-02-06

    Recent work has demonstrated that fall risk can be attributed to cognitive as well as motor deficits. Indeed, everyday walking in complex environments utilizes executive function, dual tasking, planning and scanning, all while walking forward. Pilot studies suggest that a multi-modal intervention that combines treadmill training to target motor function and a virtual reality obstacle course to address the cognitive components of fall risk may be used to successfully address the motor-cognitive interactions that are fundamental for fall risk reduction. The proposed randomized controlled trial will evaluate the effects of treadmill training augmented with virtual reality on fall risk. Three hundred older adults with a history of falls will be recruited to participate in this study. This will include older adults (n=100), patients with mild cognitive impairment (n=100), and patients with Parkinson's disease (n=100). These three sub-groups will be recruited in order to evaluate the effects of the intervention in people with a range of motor and cognitive deficits. Subjects will be randomly assigned to the intervention group (treadmill training with virtual reality) or to the active-control group (treadmill training without virtual reality). Each person will participate in a training program set in an outpatient setting 3 times per week for 6 weeks. Assessments will take place before, after, and 1 month and 6 months after the completion of the training. A falls calendar will be kept by each participant for 6 months after completing the training to assess fall incidence (i.e., the number of falls, multiple falls and falls rate). In addition, we will measure gait under usual and dual task conditions, balance, community mobility, health related quality of life, user satisfaction and cognitive function. This randomized controlled trial will demonstrate the extent to which an intervention that combines treadmill training augmented by virtual reality reduces fall risk

  13. Pre-exercise hyperhydration-induced bodyweight gain does not alter prolonged treadmill running time-trial performance in warm ambient conditions.

    Science.gov (United States)

    Gigou, Pierre-Yves; Dion, Tommy; Asselin, Audrey; Berrigan, Felix; Goulet, Eric D B

    2012-08-01

    This study compared the effect of pre-exercise hyperhydration (PEH) and pre-exercise euhydration (PEE) upon treadmill running time-trial (TT) performance in the heat. Six highly trained runners or triathletes underwent two 18 km TT runs (~28 °C, 25%-30% RH) on a motorized treadmill, in a randomized, crossover fashion, while being euhydrated or after hyperhydration with 26 mL/kg bodyweight (BW) of a 130 mmol/L sodium solution. Subjects then ran four successive 4.5 km blocks alternating between 2.5 km at 1% and 2 km at 6% gradient, while drinking a total of 7 mL/kg BW of a 6% sports drink solution (Gatorade, USA). PEH increased BW by 1.00 ± 0.34 kg (P < 0.01) and, compared with PEE, reduced BW loss from 3.1% ± 0.3% (EUH) to 1.4% ± 0.4% (HYP) (P < 0.01) during exercise. Running TT time did not differ between groups (PEH: 85.6 ± 11.6 min; PEE: 85.3 ± 9.6 min, P = 0.82). Heart rate (5 ± 1 beats/min) and rectal (0.3 ± 0.1 °C) and body (0.2 ± 0.1 °C) temperatures of PEE were higher than those of PEH (P < 0.05). There was no significant difference in abdominal discomfort and perceived exertion or heat stress between groups. Our results suggest that pre-exercise sodium-induced hyperhydration of a magnitude of 1 L does not alter 80-90 min running TT performance under warm conditions in highly-trained runners drinking ~500 mL sports drink during exercise.

  14. Pre-Exercise Hyperhydration-Induced Bodyweight Gain Does Not Alter Prolonged Treadmill Running Time-Trial Performance in Warm Ambient Conditions

    Directory of Open Access Journals (Sweden)

    Eric D. B. Goulet

    2012-08-01

    Full Text Available This study compared the effect of pre-exercise hyperhydration (PEH and pre-exercise euhydration (PEE upon treadmill running time-trial (TT performance in the heat. Six highly trained runners or triathletes underwent two 18 km TT runs (~28 °C, 25%–30% RH on a motorized treadmill, in a randomized, crossover fashion, while being euhydrated or after hyperhydration with 26 mL/kg bodyweight (BW of a 130 mmol/L sodium solution. Subjects then ran four successive 4.5 km blocks alternating between 2.5 km at 1% and 2 km at 6% gradient, while drinking a total of 7 mL/kg BW of a 6% sports drink solution (Gatorade, USA. PEH increased BW by 1.00 ± 0.34 kg (P < 0.01 and, compared with PEE, reduced BW loss from 3.1% ± 0.3% (EUH to 1.4% ± 0.4% (HYP (P < 0.01 during exercise. Running TT time did not differ between groups (PEH: 85.6 ± 11.6 min; PEE: 85.3 ± 9.6 min, P = 0.82. Heart rate (5 ± 1 beats/min and rectal (0.3 ± 0.1 °C and body (0.2 ± 0.1 °C temperatures of PEE were higher than those of PEH (P < 0.05. There was no significant difference in abdominal discomfort and perceived exertion or heat stress between groups. Our results suggest that pre-exercise sodium-induced hyperhydration of a magnitude of 1 L does not alter 80–90 min running TT performance under warm conditions in highly-trained runners drinking ~500 mL sports drink during exercise.

  15. Effect of a Binocular iPad Game vs Part-time Patching in Children Aged 5 to 12 Years With Amblyopia: A Randomized Clinical Trial.

    Science.gov (United States)

    Holmes, Jonathan M; Manh, Vivian M; Lazar, Elizabeth L; Beck, Roy W; Birch, Eileen E; Kraker, Raymond T; Crouch, Eric R; Erzurum, S Ayse; Khuddus, Nausheen; Summers, Allison I; Wallace, David K

    2016-12-01

    A binocular approach to treating anisometropic and strabismic amblyopia has recently been advocated. Initial studies have yielded promising results, suggesting that a larger randomized clinical trial is warranted. To compare visual acuity (VA) improvement in children with amblyopia treated with a binocular iPad game vs part-time patching. A multicenter, noninferiority randomized clinical trial was conducted in community and institutional practices from September 16, 2014, to August 28, 2015. Participants included 385 children aged 5 years to younger than 13 years with amblyopia (20/40 to 20/200, mean 20/63) resulting from strabismus, anisometropia, or both. Participants were randomly assigned to either 16 weeks of a binocular iPad game prescribed for 1 hour a day (190 participants; binocular group) or patching of the fellow eye prescribed for 2 hours a day (195 participants; patching group). Study follow-up visits were scheduled at 4, 8, 12, and 16 weeks. A modified intent-to-treat analysis was performed on participants who completed the 16-week trial. Binocular iPad game or patching of the fellow eye. Change in amblyopic-eye VA from baseline to 16 weeks. Of the 385 participants, 187 were female (48.6%); mean (SD) age was 8.5 (1.9) years. At 16 weeks, mean amblyopic-eye VA improved 1.05 lines (2-sided 95% CI, 0.85-1.24 lines) in the binocular group and 1.35 lines (2-sided 95% CI, 1.17-1.54 lines) in the patching group, with an adjusted treatment group difference of 0.31 lines favoring patching (upper limit of the 1-sided 95% CI, 0.53 lines). This upper limit exceeded the prespecified noninferiority limit of 0.5 lines. Only 39 of the 176 participants (22.2%) randomized to the binocular game and with log file data available performed more than 75% of the prescribed treatment (median, 46%; interquartile range, 20%-72%). In younger participants (aged 5 to amblyopia treatment, amblyopic-eye VA improved by a mean (SD) of 2.5 (1.5) lines in the binocular group and 2.8 (0

  16. A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial

    DEFF Research Database (Denmark)

    Kirkegaard, Hans; Pedersen, Asger Roer; Pettilä, Ville;

    2016-01-01

    BACKGROUND: The TTH48 trial aims to determine whether prolonged duration (48 hours) of targeted temperature management (TTM) at 33 (±1) °C results in better neurological outcomes compared to standard duration (24 hours) after six months in comatose out-of-hospital cardiac arrest (OHCA) patients...... predetermine covariates for adjusted analyses and pre-specify sub-groups for sensitivity analyses. This pre-planned SAP will reduce analysis bias and add validity to the findings of this trial on the effect of length of TTM on important clinical outcomes after cardiac arrest. TRIAL REGISTRATION: Clinical...

  17. Validation of a real-time PCR based method for detection of Clostridium botulinum types C, D and their mosaic variants C-D and D-C in a multicenter collaborative trial

    NARCIS (Netherlands)

    Woudstra, C.; Skarin, H.; Anniballi, F.; Auricchio, B.; Medici, De D.; Bano, L.; Drigo, I.; Hansen, T.; Löfström, Ch.; Hamidjaja, R.; Rotterdam, van B.; Koene, M.G.J.

    2013-01-01

    Two real-time PCR arrays based on the GeneDisc(®) cycler platform (Pall-GeneDisc Technologies) were evaluated in a multicenter collaborative trial for their capacity to specifically detect and discriminate Clostridium botulinum types C, D and their mosaic variants C-D and D-C that are associated wit

  18. Validation of a real-time PCR based method for detection of Clostridium botulinum types C, D and their mosaic variants C-D and D-C in a multicenter collaborative trial

    DEFF Research Database (Denmark)

    Woudstra, C.; Skarin, H.; Anniballi, F.

    2013-01-01

    Two real-time PCR arrays based on the GeneDisc® cycler platform (Pall-GeneDisc Technologies) were evaluated in a multicenter collaborative trial for their capacity to specifically detect and discriminate Clostridium botulinum types C, D and their mosaic variants C-D and D-C that are associated...

  19. Validation of a real-time PCR based method for detection of Clostridium botulinum types C, D and their mosaic variants C-D and D-C in a multicenter collaborative trial

    NARCIS (Netherlands)

    Woudstra, C.; Skarin, H.; Anniballi, F.; Auricchio, B.; Medici, De D.; Bano, L.; Drigo, I.; Hansen, T.; Löfström, Ch.; Hamidjaja, R.; Rotterdam, van B.; Koene, M.G.J.

    2013-01-01

    Two real-time PCR arrays based on the GeneDisc(®) cycler platform (Pall-GeneDisc Technologies) were evaluated in a multicenter collaborative trial for their capacity to specifically detect and discriminate Clostridium botulinum types C, D and their mosaic variants C-D and D-C that are associated

  20. Facilitated reperfusion with prehospital glycoprotein IIb/IIIa inhibition: predictors of complete ST-segment resolution before primary percutaneous coronary intervention in the On-TIME 2 trial: correlates of reperfusion before primary PCI

    NARCIS (Netherlands)

    Heestermans, T.; Suryapranata, H.; Berg, J.M. ten; Mosterd, A.; Gosselink, A.T.M.; Kochman, W.; Dill, T.; Houwelingen, G. van; Kolkman, E.; Werkum, J.W. van; Zijlstra, F.; Hamm, C.; Hof, A.W. van 't

    2011-01-01

    OBJECTIVE: The objective of this study is to evaluate the incidence, predictors, and outcome of complete ST-segment resolution (STR) during transportation after pretreatment with dual or triple antiplatelet therapy in the Ongoing Tirofiban in Myocardial Infarction Evaluation (On-TIME) 2 trial. METHO

  1. Clinical Trials

    Science.gov (United States)

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

  2. Beyond trial types.

    Science.gov (United States)

    Dyrholm, Mads; Vangkilde, Signe; Bundesen, Claus

    2015-05-01

    Conventional wisdom on psychological experiments has held that when one or more independent variables are manipulated it is essential that all other conditions are kept constant such that confounding factors can be assumed negligible (Woodworth, 1938). In practice, the latter assumption is often questionable because it is generally difficult to guarantee that all other conditions are constant between any two trials. Therefore, the most common way to check for confounding violations of this assumption is to split the experimental conditions in terms of "trial types" to simulate a reduction of unintended trial-by-trial variation. Here, we pose a method which is more general than the use of trial types: use of mathematical models treating measures of potentially confounding factors and manipulated variables as equals on the single-trial level. We show how the method can be applied with models that subsume under the generalized linear item response theory (GLIRT), which is the case for most of the well-known psychometric models (Mellenbergh, 1994). As an example, we provide a new analysis of a single-letter recognition experiment using a nested likelihood ratio test that treats manipulated and measured variables equally (i.e., in exactly the same way) on the single-trial level. The test detects a confounding interaction with time-on-task as a single-trial measure and yields a substantially better estimate of the effect size of the main manipulation compared with an analysis made in terms of trial types.

  3. A Mobile Device App to Reduce Time to Drug Delivery and Medication Errors During Simulated Pediatric Cardiopulmonary Resuscitation: A Randomized Controlled Trial

    Science.gov (United States)

    Combescure, Christophe; Lacroix, Laurence; Haddad, Kevin; Sanchez, Oliver; Gervaix, Alain; Lovis, Christian; Manzano, Sergio

    2017-01-01

    Background During pediatric cardiopulmonary resuscitation (CPR), vasoactive drug preparation for continuous infusion is both complex and time-consuming, placing children at higher risk than adults for medication errors. Following an evidence-based ergonomic-driven approach, we developed a mobile device app called Pediatric Accurate Medication in Emergency Situations (PedAMINES), intended to guide caregivers step-by-step from preparation to delivery of drugs requiring continuous infusion. Objective The aim of our study was to determine whether the use of PedAMINES reduces drug preparation time (TDP) and time to delivery (TDD; primary outcome), as well as medication errors (secondary outcomes) when compared with conventional preparation methods. Methods The study was a randomized controlled crossover trial with 2 parallel groups comparing PedAMINES with a conventional and internationally used drugs infusion rate table in the preparation of continuous drug infusion. We used a simulation-based pediatric CPR cardiac arrest scenario with a high-fidelity manikin in the shock room of a tertiary care pediatric emergency department. After epinephrine-induced return of spontaneous circulation, pediatric emergency nurses were first asked to prepare a continuous infusion of dopamine, using either PedAMINES (intervention group) or the infusion table (control group), and second, a continuous infusion of norepinephrine by crossing the procedure. The primary outcome was the elapsed time in seconds, in each allocation group, from the oral prescription by the physician to TDD by the nurse. TDD included TDP. The secondary outcome was the medication dosage error rate during the sequence from drug preparation to drug injection. Results A total of 20 nurses were randomized into 2 groups. During the first study period, mean TDP while using PedAMINES and conventional preparation methods was 128.1 s (95% CI 102-154) and 308.1 s (95% CI 216-400), respectively (180 s reduction, P=.002). Mean

  4. Buying Time I: a prospective, controlled trial of a joint health/social care residential rehabilitation unit for older people on discharge from hospital.

    Science.gov (United States)

    Trappes-Lomax, Tessa; Ellis, Annie; Fox, Mary; Taylor, Rod; Power, Michael; Stead, Jonathan; Bainbridge, Ian

    2006-01-01

    The study's objective was to determine the effectiveness of a joint NHS/Social Services rehabilitation unit (a form of intermediate care) for older people on discharge from community hospital, compared with 'usual' community services. This was a controlled clinical trial in a practice setting. The intervention was 6 weeks in a rehabilitation unit where individuals worked with care/rehabilitation assistants and occupational therapists to regain independence. Controls went home with the health/social care services they would ordinarily receive. Participants were from two matched geographical areas in Devon: one with a rehabilitation unit, one without. Recruitment was from January 1999 to October 2001 in 10 community hospitals. Study eligibility was assessed using the unit's inclusion/exclusion criteria: 55 years or older and 'likely to benefit from a short-term rehabilitation programme' ('potential to improve', 'realistic and achievable goals' and 'motivation to participate'). Ninety-four people were recruited to the intervention and 112 to the control. The mean (standard deviation) age was 81.8 (8.0) years. The main outcome measure was prevention of institutionalisation assessed by the number of days from baseline interview to admission to residential/nursing care or death ('survival-at-home time'). Secondary outcome measures were time to hospital re-admission over 12 months, quality of life and coping ability. There were no significant differences between the groups on any outcome measure. Adjusted hazard ratio (95% CI) for 'survival-at-home time' was 1.13 (0.70-1.84), and 0.84 (0.53-1.33) for 'time to hospital re-admission'. However, attending the unit was associated with earlier hospital discharge. Median (interquartile range) days in hospital for the intervention graph was 27 (20, 40), and for the control graph was 35 (22, 47) (U = 4234, P = 0.029). These findings suggest a stay in a rehabilitation unit is no more effective than 'usual' care at diverting older

  5. A placebo-controlled, double-blind clinical trial to evaluate the efficacy of Imedeen® Time Perfection® for improving the appearance of photodamaged skin

    Directory of Open Access Journals (Sweden)

    Stephens TJ

    2016-03-01

    Full Text Available Thomas J Stephens,1 Monya L Sigler,1 James H Herndon Jr,2 Lisa Dispensa,3 Anne Le Moigne3 1Thomas J. Stephens and Associates, Inc., Richardson, TX, 2Dermatology Center of Dallas, Dallas, TX, 3Pfizer Consumer Healthcare, Madison, NJ, USA Objective: To assess the efficacy of Imedeen Time Perfection for improving the appearance and condition of photoaged skin in healthy women. Methods: This randomized, double-blind, placebo-controlled clinical trial enrolled healthy women, 35–60 years of age, with Fitzpatrick I–III and Glogau II–III skin types and mild-to-moderate facial fine lines/wrinkles. The eligible subjects were randomized to receive two tablets daily of either Imedeen Time Perfection (Imedeen or a matching placebo for 12 weeks. Efficacy assessments included investigator rating of 16 photoaging parameters (ie, global facial appearance and 15 individual facial parameters and the average of all parameters, instrumentation (ie, ultrasound dermal density, moisture level of the stratum corneum, transepidermal water loss, cutometry, and subjects' self-assessment. Differences in the mean change from baseline to week 12 values on these outcomes were compared between Imedeen and placebo using analysis of variance or a paired t-test. Results: Seventy-four subjects with primarily Fitzpatrick skin type III (78%–79% and Glogau type III (53%–58% completed the study (Imedeen: n=36; placebo: n=38. The mean difference in change from baseline to week 12 for global facial assessment significantly favored Imedeen over placebo (−0.52; P=0.0017. Additionally, the mean differences in the average of all facial photoaging parameters (−0.29, mottled hyperpigmentation (−0.25, tactile laxity (−0.24, dullness (−0.47, and tactile roughness (−0.62 significantly favored Imedeen over placebo (P≤0.05. Significantly greater increases in ultrasound dermal density (+11% vs +1%; P≤0.05 and stratum corneum moisturization (+30% vs +6%; P≤0.05 were also

  6. Reporting of loss to follow-up information in randomised controlled trials with time-to-event outcomes: a literature survey

    Directory of Open Access Journals (Sweden)

    Bender Ralf

    2011-09-01

    Full Text Available Abstract Background To assess the reporting of loss to follow-up (LTFU information in articles on randomised controlled trials (RCTs with time-to-event outcomes, and to assess whether discrepancies affect the validity of study results. Methods Literature survey of all issues of the BMJ, Lancet, JAMA, and New England Journal of Medicine published between 2003 and 2005. Eligible articles were reports of RCTs including at least one Kaplan-Meier plot. Articles were classified as "assessable" if sufficient information was available to assess LTFU. In these articles, LTFU information was derived from Kaplan-Meier plots, extracted from the text, and compared. Articles were then classified as "consistent" or "not consistent". Sensitivity analyses were performed to assess the validity of study results. Results 319 eligible articles were identified. 187 (59% were classified as "assessable", as they included sufficient information for evaluation; 140 of 319 (44% presented consistent LTFU information between the Kaplan-Meier plot and text. 47 of 319 (15% were classified as "not consistent". These 47 articles were included in sensitivity analyses. When various imputation methods were used, the results of a chi2-test applied to the corresponding 2 × 2 table changed and hence were not robust in about half of the studies. Conclusions Less than half of the articles on RCTs using Kaplan-Meier plots provide assessable and consistent LTFU information, thus questioning the validity of the results and conclusions of many studies presenting survival analyses. Authors should improve the presentation of both Kaplan-Meier plots and LTFU information, and reviewers of study publications and journal editors should critically appraise the validity of the information provided.

  7. An Evaluation of Time-Trial Based Predictions of V[Combining Dot Above]O2max and Recommended Training Paces for Collegiate and Recreational Runners.

    Science.gov (United States)

    Scudamore, E M; Barry, V W; Coons, J M

    2017-04-15

    The purpose of the current study was to determine the accuracy of Jack Daniels' VDOT Running Calculator for the prediction of V[Combining Dot Above]O2max, and recommendations of interval and training paces (pIN & pTH) in samples of NCAA Division 1 track athletes (ATH, n = 11) and recreational runners (REC; n = 9). Predicted variable data were obtained using results from indoor 5km time-trials. Data from the VDOT calculator was compared to laboratory tested V[Combining Dot Above]O2max, pace at V[Combining Dot Above]O2max (V[Combining Dot Above]O2maxpace), and lactate threshold pace (LTpace). Results indicated that VDOT underestimated V[Combining Dot Above]O2max in ATH (t (10) = -6.00, p V[Combining Dot Above]O2max was significantly greater in REC than ATH (p = .0031, d = 1.59). pIN was slower than V[Combining Dot Above]O2maxpace in REC (t (8) = -4.26, p = .003, d = 1.76), but not different in ATH (t (10) = 0.52, p = .614, d = 0.14). Conversely, pTH was faster than LTpace in ATH (t (8) = -4.17, p = .003, d = 1.49), but not different in REC (t (8) = 1.64, p = .139, d =0.57). Practically, pTH can be confidently used for threshold training regardless of ability level. pIN also appeared to be accurate for ATH, but may be not be optimal for improving V[Combining Dot Above]O2max in REC. Practitioners should interpret VDOT with caution as it may underestimate V[Combining Dot Above]O2max.

  8. Tai chi qigong as a means to improve night-time sleep quality among older adults with cognitive impairment: a pilot randomized controlled trial.

    Science.gov (United States)

    Chan, Aileen Wk; Yu, Doris Sf; Choi, K C; Lee, Diana Tf; Sit, Janet Wh; Chan, Helen Yl

    2016-01-01

    Age-related cognitivee decline is a growing public health concern worldwide. More than a quarter of adults with cognitive impairment experience sleep disturbance. The objective of this pilot study was to evaluate the preliminary effects of tai chi qigong (TCQ) on improving the night-time sleep quality of older adults with cognitive impairment. Older adults with cognitive impairment who complain of sleep disturbance. A randomized controlled trial with two groups. Fifty-two subjects were recruited from two district elderly community centers and randomly assigned to either the TCQ group (n=27) or the control group (n=25). The intervention group received TCQ training consisting of two 60-minute sessions each week for 2 months. The control group was advised to maintain their usual activities. Sleep quality was measured by the Chinese Pittsburgh Sleep Quality Index. Quality of life was measured by Short-form 12, cognitive functions measured by mini-mental state examination, and subjective memory deficits measured by the memory inventory for Chinese. Data were collected at baseline, 2 months, and 6 months. Significant results were noted at 6 months in the Chinese Pittsburgh Sleep Quality Index global score (P=0.004), sleep duration (P=0.003), habitual sleep efficiency (P=0.002), and the Short-form 12 mental health component (P<0.001). The TCQ participants reported better sleep quality and a better (quality of life) mental health component than the control group. TCQ can be considered a useful nonpharmacological approach for improving sleep quality in older adults with cognitive impairment. CUHK_CCT00448 (https://www2.ccrb.cuhk.edu.hk/registry/public/287).

  9. SU-E-QI-21: Iodinated Contrast Agent Time Course In Human Brain Metastasis: A Study For Stereotactic Synchrotron Radiotherapy Clinical Trials

    Energy Technology Data Exchange (ETDEWEB)

    Obeid, L; Esteve, F; Adam, J [Grenoble Institut des Neurosciences, La Tronche, Isere (France); Tessier, A; Balosso, J [Centre Hospitalier Universitaire, La Tronche, Isere (France)

    2014-06-15

    Purpose: Synchrotron stereotactic radiotherapy (SSRT) is an innovative treatment combining the selective accumulation of heavy elements in tumors with stereotactic irradiations using monochromatic medium energy x-rays from a synchrotron source. Phase I/II clinical trials on brain metastasis are underway using venous infusion of iodinated contrast agents. The radiation dose enhancement depends on the amount of iodine in the tumor and its time course. In the present study, the reproducibility of iodine concentrations between the CT planning scan day (Day 0) and the treatment day (Day 10) was assessed in order to predict dose errors. Methods: For each of days 0 and 10, three patients received a biphasic intravenous injection of iodinated contrast agent (40 ml, 4 ml/s, followed by 160 ml, 0.5 ml/s) in order to ensure stable intra-tumoral amounts of iodine during the treatment. Two volumetric CT scans (before and after iodine injection) and a multi-slice dynamic CT of the brain were performed using conventional radiotherapy CT (Day 0) or quantitative synchrotron radiation CT (Day 10). A 3D rigid registration was processed between images. The absolute and relative differences of absolute iodine concentrations and their corresponding dose errors were evaluated in the GTV and PTV used for treatment planning. Results: The differences in iodine concentrations remained within the standard deviation limits. The 3D absolute differences followed a normal distribution centered at zero mg/ml with a variance (∼1 mg/ml) which is related to the image noise. Conclusion: The results suggest that dose errors depend only on the image noise. This study shows that stable amounts of iodine are achievable in brain metastasis for SSRT treatment in a 10 days interval.

  10. A randomised controlled trial of sensory awareness training and additional motor practice for learning scalpel skills in podiatry students.

    Science.gov (United States)

    Causby, Ryan S; McDonnell, Michelle N; Reed, Lloyd; Hillier, Susan L

    2016-12-05

    The process of using a scalpel, like all other motor activities, is dependent upon the successful integration of afferent (sensory), cognitive and efferent (motor) processes. During learning of these skills, even if motor practice is carefully monitored there is still an inherent risk involved. It is also possible that this strategy could reinforce high levels of anxiety experienced by the student and affect student self-efficacy, causing detrimental effects on motor learning. An alternative training strategy could be through targeting sensory rather than motor processes. Second year podiatry students who were about to commence learning scalpel skills were recruited. Participants were randomly allocated into sensory awareness training (Sensory), additional motor practice (Motor) or usual teaching only (Control) groups. Participants were then evaluated on psychological measures (Intrinsic Motivation Inventory) and dexterity measures (Purdue Pegboard, Grooved Pegboard Test and a grip-lift task). A total of 44 participants were included in the study. There were no baseline differences or significant differences between the three groups over time on the Perceived Competence, Effort/ Importance or Pressure/ Tension, psychological measures. All groups showed a significant increase in Perceived Competence over time (F1,41 = 13.796, p = 0.001). Only one variable for the grip-lift task (Preload Duration for the non-dominant hand) showed a significant difference over time between the groups (F2,41 = 3.280, p = 0.038), specifically, Motor and Control groups. The use of sensory awareness training, or additional motor practice did not provide a more effective alternative compared with usual teaching. Further research may be warranted using more engaged training, provision of supervision and greater participant numbers. Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12616001428459 . Registered 13(th) October 2016. Registered Retrospectively.

  11. 直排式真空预压法在软基处理工程中的应用%Application of Straight-line Vacuum Preloading Method in Soft Base Reinforcement

    Institute of Scientific and Technical Information of China (English)

    李新召; 王桂松; 张晓杰

    2014-01-01

    The conventional vacuum preloading method is optimized to be straight-line vacuum preloading method in the project,which gives up medium-coarse sand,drain boards and filters are connected to reduce vacuum degree transmission path,decrease energy consumption and reach the planned effect. The theoretical computation and detection result prove that the application of straight-line vacuum preloading method saves cost and realizes reasonable construction period in contrast with the conventional technology. The improved soft base detection results meet the engineering requirements for soft soil compression coefficient,water content,void ratio,consolidation degree,settlement rate and vane-shear strength.%本工程采用的直排式真空预压法,是对传统真空预压工艺的优化。即取消中粗砂,排水板直接连接在滤管上,缩短真空度传递路径,降低能耗,取得预期效果。理论计算和检测均表明:直排式真空预压相对于传统真空预压工艺,可节约成本,工期合理;地基处理后检测结果表明:处理后软土压缩系数、含水率、孔隙比降低,固结度、沉降速率和十字板抗剪强度等均满足要求。

  12. Effectiveness of a nurse-led intensive home-visitation programme for first-time teenage mothers (Building Blocks): a pragmatic randomised controlled trial.

    Science.gov (United States)

    Robling, Michael; Bekkers, Marie-Jet; Bell, Kerry; Butler, Christopher C; Cannings-John, Rebecca; Channon, Sue; Martin, Belen Corbacho; Gregory, John W; Hood, Kerry; Kemp, Alison; Kenkre, Joyce; Montgomery, Alan A; Moody, Gwenllian; Owen-Jones, Eleri; Pickett, Kate; Richardson, Gerry; Roberts, Zoë E S; Ronaldson, Sarah; Sanders, Julia; Stamuli, Eugena; Torgerson, David

    2016-01-09

    Many countries now offer support to teenage mothers to help them to achieve long-term socioeconomic stability and to give a successful start to their children. The Family Nurse Partnership (FNP) is a licensed intensive home-visiting intervention developed in the USA and introduced into practice in England that involves up to 64 structured home visits from early pregnancy until the child's second birthday by specially recruited and trained family nurses. We aimed to assess the effectiveness of giving the programme to teenage first-time mothers on infant and maternal outcomes up to 24 months after birth. We did a pragmatic, non-blinded, randomised controlled, parallel-group trial in community midwifery settings at 18 partnerships between local authorities and primary and secondary care organisations in England. Eligible participants were nulliparous and aged 19 years or younger, and were recruited at less than 25 weeks' gestation. Field-based researchers randomly allocated mothers (1:1) via remote randomisation (telephone and web) to FNP plus usual care (publicly funded health and social care) or to usual care alone. Allocation was stratified by site and minimised by gestation (language of data collection (English vs non-English). Mothers and assessors (local researchers at baseline and 24 months' follow-up) were not masked to group allocation, but telephone interviewers were blinded. Primary endpoints were biomarker-calibrated self-reported tobacco use by the mother at late pregnancy, birthweight of the baby, the proportion of women with a second pregnancy within 24 months post-partum, and emergency attendances and hospital admissions for the child within 24 months post-partum. Analyses were by intention to treat. This trial is registered with ISRCTN, number ISRCTN23019866. Between June 16, 2009, and July 28, 2010, we screened 3251 women. After enrolment, 823 women were randomly assigned to receive FNP and 822 to usual care. All follow-up data were retrieved by

  13. A Prospective Randomized Clinical Trial of Single vs. Double Layer Closure of Hysterotomy at the Time of Cesarean Delivery: The Effect on Uterine Scar Thickness.

    Science.gov (United States)

    Bamberg, C; Dudenhausen, J W; Bujak, V; Rodekamp, E; Brauer, M; Hinkson, L; Kalache, K; Henrich, W

    2016-09-14

    Purpose: We undertook a randomized clinical trial to examine the outcome of a single vs. a double layer uterine closure using ultrasound to assess uterine scar thickness. Materials and Methods: Participating women were allocated to one of three uterotomy suture techniques: continuous single layer unlocked suturing, continuous locked single layer suturing, or double layer suturing. Transvaginal ultrasound of uterine scar thickness was performed 6 weeks and 6 - 24 months after Cesarean delivery. Sonographers were blinded to the closure technique. Results: An "intent-to-treat" and "as treated" ANOVA analysis included 435 patients (n = 149 single layer unlocked suturing, n = 157 single layer locked suturing, and n = 129 double layer suturing). 6 weeks postpartum, the median scar thickness did not differ among the three groups: 10.0 (8.5 - 12.3 mm) single layer unlocked vs. 10.1 (8.2 - 12.7 mm) single layer locked vs. 10.8 (8.1 - 12.8 mm) double layer; (p = 0.84). At the time of the second follow-up, the uterine scar was not significantly (p = 0.06) thicker if the uterus had been closed with a double layer closure 7.3 (5.7 - 9.1 mm), compared to single layer unlocked 6.4 (5.0 - 8.8 mm) or locked suturing techniques 6.8 (5.2 - 8.7 mm). Women who underwent primary or elective Cesarean delivery showed a significantly (p = 0.03, p = 0.02, "as treated") increased median scar thickness after double layer closure vs. single layer unlocked suture. Conclusion: A double layer closure of the hysterotomy is associated with a thicker myometrium scar only in primary or elective Cesarean delivery patients.

  14. Poor concordance between CA-125 and RECIST at the time of disease progression in patients with platinum-resistant ovarian cancer: analysis of the AURELIA trial.

    Science.gov (United States)

    Lindemann, K; Kristensen, G; Mirza, M R; Davies, L; Hilpert, F; Romero, I; Ayhan, A; Burges, A; Rubio, M J; Raspagliesi, F; Huizing, M; Creemers, G-J; Lykka, M; Lee, C K; Gebski, V; Pujade-Lauraine, E

    2016-08-01

    Data on CA-125 as a predictor of disease progression (PD) in ovarian cancer come predominantly from patients with platinum-sensitive disease receiving chemotherapy alone. We assessed concordance between CA-125-defined and RECIST-defined PD using data from the Gynecologic Cancer InterGroup (GCIG) randomized phase III AURELIA trial in platinum-resistant ovarian cancer (PROC). Patients with PROC were randomized to receive single-agent chemotherapy with or without bevacizumab. PD by CA-125 was defined according to GCIG criteria (except that confirmatory CA-125 measurement was not required). This exploratory analysis included patients with RECIST PD and a CA-125 reading ≤28 days before and ≤21 days after RECIST-defined PD. Of 218 eligible patients, only 94 (43%, 95% confidence interval 36% to 50%) had concordant RECIST and CA-125 PD status (42% in the chemotherapy-alone arm; 45% in the bevacizumab combination arm, P = 0.6). There was no evidence of CA-125-defined PD in the remaining 124 patients despite PD according to imaging. There were no significant differences in baseline characteristics between patients with PD defined by both RECIST and CA-125 and those with RECIST-only PD. CA-125 was even less sensitive in detecting PD in patients with early (<8 weeks after randomization) compared with later RECIST-defined PD (69% versus 53%, respectively, not meeting CA-125 criteria; P = 0.053). There was no significant difference in survival after PD in patients with concordant PD by RECIST and CA-125 versus those with PD only by RECIST. We validated our findings in an independent study population of PROC. In this platinum-resistant population, PD was typically detected earlier by imaging than by CA-125, irrespective of bevacizumab treatment. Disease status by CA-125 at the time of PD was not prognostic for overall survival. Regular radiologic assessment as well as symptom benefit assessment should be considered during PROC follow-up. © The Author 2016. Published by

  15. Effects of aspirin on risk and severity of early recurrent stroke after transient ischaemic attack and ischaemic stroke : time-course analysis of randomised trials

    NARCIS (Netherlands)

    Rothwell, Peter M; Algra, Ale; Chen, Zhengming; Diener, Hans-Christoph; Norrving, Bo; Mehta, Ziyah

    2016-01-01

    BACKGROUND: Aspirin is recommended for secondary prevention after transient ischaemic attack (TIA) or ischaemic stroke on the basis of trials showing a 13% reduction in long-term risk of recurrent stroke. However, the risk of major stroke is very high for only the first few days after TIA and minor

  16. Social Problem Solving and Depressive Symptoms over Time: A Randomized Clinical Trial of Cognitive-Behavioral Analysis System of Psychotherapy, Brief Supportive Psychotherapy, and Pharmacotherapy

    Science.gov (United States)

    Klein, Daniel N.; Leon, Andrew C.; Li, Chunshan; D'Zurilla, Thomas J.; Black, Sarah R.; Vivian, Dina; Dowling, Frank; Arnow, Bruce A.; Manber, Rachel; Markowitz, John C.; Kocsis, James H.

    2011-01-01

    Objective: Depression is associated with poor social problem solving, and psychotherapies that focus on problem-solving skills are efficacious in treating depression. We examined the associations between treatment, social problem solving, and depression in a randomized clinical trial testing the efficacy of psychotherapy augmentation for…

  17. Social Problem Solving and Depressive Symptoms over Time: A Randomized Clinical Trial of Cognitive-Behavioral Analysis System of Psychotherapy, Brief Supportive Psychotherapy, and Pharmacotherapy

    Science.gov (United States)

    Klein, Daniel N.; Leon, Andrew C.; Li, Chunshan; D'Zurilla, Thomas J.; Black, Sarah R.; Vivian, Dina; Dowling, Frank; Arnow, Bruce A.; Manber, Rachel; Markowitz, John C.; Kocsis, James H.

    2011-01-01

    Objective: Depression is associated with poor social problem solving, and psychotherapies that focus on problem-solving skills are efficacious in treating depression. We examined the associations between treatment, social problem solving, and depression in a randomized clinical trial testing the efficacy of psychotherapy augmentation for…

  18. Inter-laboratory ring trial to evaluate real-time reverse transcription polymerase chain reaction methods used for detection of infectious pancreatic necrosis virus in Chile

    Directory of Open Access Journals (Sweden)

    David Tapia

    2017-07-01

    Conclusions: Overall, the ring trial showed high values of sensitivity and specificity, with some problems of repeatability and inter-laboratory variability. This last issue needs to be addressed in order to allow harmonized diagnostic of IPNV within the country. We recommend the use of the NRL methods as validated and reliable qRT-PCR protocols for the detection of IPNV.

  19. Effects of aspirin on risk and severity of early recurrent stroke after transient ischaemic attack and ischaemic stroke : time-course analysis of randomised trials

    NARCIS (Netherlands)

    Rothwell, Peter M; Algra, Ale; Chen, Zhengming; Diener, Hans-Christoph; Norrving, Bo; Mehta, Ziyah

    2016-01-01

    BACKGROUND: Aspirin is recommended for secondary prevention after transient ischaemic attack (TIA) or ischaemic stroke on the basis of trials showing a 13% reduction in long-term risk of recurrent stroke. However, the risk of major stroke is very high for only the first few days after TIA and minor

  20. Assessing sex-differences and the effect of timing of vaccination on immunogenicity, reactogenicity and efficacy of vaccines in young children: study protocol for an individual participant data meta-analysis of randomised controlled trials

    Science.gov (United States)

    Voysey, Merryn; Pollard, Andrew J; Perera, Rafael; Fanshawe, Thomas R

    2016-01-01

    Introduction Disease incidence differs between males and females for some infectious or inflammatory diseases. Sex-differences in immune responses to some vaccines have also been observed, mostly to viral vaccines in adults. Little evidence is available on whether sex-differences occur in response to immunisation in infancy even though this is the age group in which most vaccines are administered. Factors other than sex, such as timing or coadministration of other vaccines, can also influence the immune response to vaccination. Methods and analysis Individual participant data meta-analysis of randomised controlled trials of vaccines in healthy infants and young children will be conducted. Fully anonymised data from ∼170 randomised controlled trials of vaccines for diphtheria, tetanus, Bordetella pertussis, polio, Haemophilus influenzae type B, hepatitis B, Streptococcus pneumoniae, Neisseria meningitidis, measles, mumps, rubella, varicella and rotavirus will be combined for analysis. Outcomes include measures of immunogenicity (immunoglobulins), reactogenicity, safety and disease-specific clinical efficacy. Data from trials of vaccines containing similar components will be combined in hierarchical models and the effect of sex and timing of vaccinations estimated for each outcome separately. Ethics and dissemination Systematic reviews of published estimates of sex-differences cannot adequately answer questions in this field since such comparisons are never the main purpose of a clinical trial, thus a large degree of reporting bias exists in the published literature. Recent improvements in the widespread availability of individual participant data from randomised controlled trials makes it feasible to conduct extensive individual participant data meta-analyses which were previously impossible, thereby reducing the effect of publication or reporting bias on the understanding of the infant immune response. Preliminary results will be available in 2016 with final

  1. The Impact of Curtin University's Activity, Food and Attitudes Program on Physical Activity, Sedentary Time and Fruit, Vegetable and Junk Food Consumption among Overweight and Obese Adolescents: A Waitlist Controlled Trial

    OpenAIRE

    Straker, Leon M.; Howie, Erin K.; Smith, Kyla L.; Fenner, Ashley A; Kerr, Deborah A; Olds, Tim S.; Abbott, Rebecca A; Smith, Anne J

    2014-01-01

    BACKGROUND: To determine the effects of participation in Curtin University's Activity, Food and Attitudes Program (CAFAP), a community-based, family-centered behavioural intervention, on the physical activity, sedentary time, and healthy eating behaviours of overweight and obese adolescents. METHODS: In this waitlist controlled clinical trial in Western Australia, adolescents (n = 69, 71% female, mean age 14.1 (SD 1.6) years) and parents completed an 8-week intervention followed by 12 months ...

  2. Historical time to disease progression and progression-free survival in patients with recurrent/refractory neuroblastoma treated in the modern era on Children's Oncology Group early-phase trials.

    Science.gov (United States)

    London, Wendy B; Bagatell, Rochelle; Weigel, Brenda J; Fox, Elizabeth; Guo, Dongjing; Van Ryn, Collin; Naranjo, Arlene; Park, Julie R

    2017-09-08

    Early-phase trials in patients with recurrent neuroblastoma historically used an objective "response" of measureable disease (Response Evaluation Criteria In Solid Tumors [RECIST], without bone/bone marrow assessment) to select agents for further study. Historical cohorts may be small and potentially biased; to the authors' knowledge, disease recurrence studies from international registries are outdated. Using a large recent cohort of patients with recurrent/refractory neuroblastoma from Children's Oncology Group (COG) modern-era early-phase trials, the authors determined outcome and quantified parameters for designing future studies. The first early-phase COG trial enrollment (sequential) of 383 distinct patients with recurrent/refractory neuroblastoma on 23 phase 1, 3 phase 1/2, and 9 phase 2 trials (August 2002 to January 2014) was analyzed for progression-free survival (PFS), overall survival (OS), and time to disease progression (TTP). Planned frontline therapy for patients with high-risk neuroblastoma included hematopoietic stem cell transplantation (approximately two-thirds of patients underwent ≥1 hematopoietic stem cell transplantation); 13.2% of patients received dinutuximab. From the time of the patient's first early-phase trial enrollment (383 patients), the 1-year and 4-year PFS rates ( ± standard error) were 21% ± 2% and 6% ± 1%, respectively, whereas the 1-year and 4-year OS rates were 57% ± 3% and 20% ± 2%, respectively. The median TTP was 58 days (interquartile range, 31-183 days [350 patients]); the median follow-up was 25.3 months (33 patients were found to be without disease recurrence/progression). The median time from diagnosis to first disease recurrence/progression was 18.7 months (range, 1.4-64.8 months) (176 patients). MYCN amplification and 11q loss of heterozygosity were prognostic of worse PFS and OS (P = .003 and Pphase trial enrollment. This recent COG cohort of patients with recurrent

  3. Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study.

    Science.gov (United States)

    Potter, Shelley; Mills, Nicola; Cawthorn, Simon J; Donovan, Jenny; Blazeby, Jane M

    2014-03-14

    Well-designed randomised clinical trials (RCTs) provide the best evidence to inform decision-making and should be the default option for evaluating surgical procedures. Such trials can be challenging, and surgeons' preferences may influence whether trials are initiated and successfully conducted and their results accepted. Preferences are particularly problematic when surgeons' views play a key role in procedure selection and patient eligibility. The bases of such preferences have rarely been explored. Our aim in this qualitative study was to investigate surgeons' preferences regarding the feasibility of surgical RCTs and their understanding of study design issues using breast reconstruction surgery as a case study. Semistructured qualitative interviews were undertaken with a purposive sample of 35 professionals practicing at 15 centres across the United Kingdom. Interviews were transcribed verbatim and analysed thematically using constant comparative techniques. Sampling, data collection and analysis were conducted concurrently and iteratively until data saturation was achieved. Surgeons often struggle with the concept of equipoise. We found that if surgeons did not feel 'in equipoise', they did not accept randomisation as a method of treatment allocation. The underlying reasons for limited equipoise were limited appreciation of the methodological weaknesses of data derived from nonrandomised studies and little understanding of pragmatic trial design. Their belief in the value of RCTs for generating high-quality data to change or inform practice was not widely held. There is a need to help surgeons understand evidence, equipoise and bias. Current National Institute of Health Research/Medical Research Council investment into education and infrastructure for RCTs, combined with strong leadership, may begin to address these issues or more specific interventions may be required.

  4. Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study

    Science.gov (United States)

    2014-01-01

    Background Well-designed randomised clinical trials (RCTs) provide the best evidence to inform decision-making and should be the default option for evaluating surgical procedures. Such trials can be challenging, and surgeons’ preferences may influence whether trials are initiated and successfully conducted and their results accepted. Preferences are particularly problematic when surgeons’ views play a key role in procedure selection and patient eligibility. The bases of such preferences have rarely been explored. Our aim in this qualitative study was to investigate surgeons’ preferences regarding the feasibility of surgical RCTs and their understanding of study design issues using breast reconstruction surgery as a case study. Methods Semistructured qualitative interviews were undertaken with a purposive sample of 35 professionals practicing at 15 centres across the United Kingdom. Interviews were transcribed verbatim and analysed thematically using constant comparative techniques. Sampling, data collection and analysis were conducted concurrently and iteratively until data saturation was achieved. Results Surgeons often struggle with the concept of equipoise. We found that if surgeons did not feel ‘in equipoise’, they did not accept randomisation as a method of treatment allocation. The underlying reasons for limited equipoise were limited appreciation of the methodological weaknesses of data derived from nonrandomised studies and little understanding of pragmatic trial design. Their belief in the value of RCTs for generating high-quality data to change or inform practice was not widely held. Conclusion There is a need to help surgeons understand evidence, equipoise and bias. Current National Institute of Health Research/Medical Research Council investment into education and infrastructure for RCTs, combined with strong leadership, may begin to address these issues or more specific interventions may be required. PMID:24628821

  5. Analysis on Consolidation of Hydraulically Reclaimed Soil under Vacuum Preloading with Change of Permeability%真空预压下考虑渗透系数变化的吹填土地基固结分析

    Institute of Scientific and Technical Information of China (English)

    牛飞; 邱长林; 闫澍旺; 纪玉诚

    2013-01-01

    Hydraulically reclaimed soil's water content is more than 80% with high void ratio. When the hydraulically reclaimed soil is strengthened by vacuum preloading,its void ratio varies greatly,which makes its permeability change greatly. Reclaimed soil's consolidation properties and mechanical parameters under vacuum loading are obtained by laboratory vacuum model test. Using the modified Cambridge model,and taking into account the relation between permeability coefficient and void ratio,Biot's consolidation theory is used to analysis the pore pressure and void ratio of reclaimed soil in the model tank under vacuum loading. Compared with measured results,the calculation results show that this model can well be used to analyze the reclaimed soil's consolidation under vacuum loading. The calculation results also show that the soil close to the prefabricated drains is compacted in a very short time, resulting in the slow consolidation of the reclaimed soil. If the degree of consolidation is calculated by using a model that doesn't consider the change of permeability, the calculated valves will be higher than the calculated results by using a model that considers the change of permeability. Therefore,the consideration of the change of permeability during the consolidation of reclaimed soil foundation is necessary.%  吹填土的含水率高达80%以上,孔隙比大。使用真空预压法加固吹填土,土体孔隙比变化很大,土体的渗透系数也随之发生很大的变化。通过室内真空模型试验获取土样在真空荷载下的固结规律和力学参数。采用修正的剑桥模型,并考虑渗透系数随孔隙比变化的非线性关系,运用比奥固结理论分析模型槽试验中土体在真空荷载下的孔压、孔隙比变化规律。其计算结果与实测值对比表明,该模型能很好地分析吹填土在真空荷载下的固结规律。计算结果显示:贴近排水板的土体在很短时间内被压密,造成

  6. Nonlinear consolidation of subsoil by vacuum preloading based on bi-logarithmic coordinate compression model%基于双对数压缩模型的真空预压非线性固结解

    Institute of Scientific and Technical Information of China (English)

    韩文君; 刘松玉; 章定文; 刘维正

    2013-01-01

    考虑真空荷载实际边界条件,引入对土体压缩曲线线性化的双对数坐标,建立了真空预压砂井地基非线性固结近似解答;利用模型试验结果验证了解答的可靠性,并分析了真空度衰减和土性参数对固结性状的影响。研究结果表明,考虑了真空荷载衰减及双对数坐标的解答计算得到的土体沉降、超静孔压与实测值最为接近。对于超固结土而言,基于变形计算的固结度随着压缩指数与渗透指数比值的增大而减小,随着真空荷载衰减系数的减小而减小;当压缩指数与渗透指数比值大于1时,正常固结状态中基于孔压计算的固结度随真空荷载衰减系数的减小而增大。随着压缩指数与回弹指数比值的增大,地基超静孔压消散速率也随之增加,沉降速率在超固结状态时随之减缓,在正常固结状态时则随之加快,土体由超固结状态进入正常固结状态的时间随之变长。%Based on the bi-logarithmic coordinate compression model and actual vacuum pressure along the drain for normally consolidated and over-consolidated clays, a new analytical solution of the radial consolidation of subsoil by vacuum preloading was derived.The analytical solution was verified by the model test, and the influences of vacuum pressure attenuation and soil parameters on consolidation were analyzed.The results show that the calculated settlement and the excess pore wa-ter pressure are most close to the measured data in model tests.For over-consolidated clays, the con-solidation degree calculated by deformation decreases with the increase of the ratio of the compres-sion index and the permeability index and with the decease of the vacuum pressure attenuation coeffi-cient.When the ratio of the compression index and the permeability index is more than one, the con-solidation degree in normal consolidation state calculated by pore water pressure increases with the decrease of

  7. Geographic differences in time to culture conversion in liquid media: Tuberculosis Trials Consortium study 28. Culture conversion is delayed in Africa.

    Directory of Open Access Journals (Sweden)

    William R Mac Kenzie

    Full Text Available BACKGROUND: Tuberculosis Trials Consortium Study 28, was a double blind, randomized, placebo-controlled, phase 2 clinical trial examining smear positive pulmonary Mycobacterium tuberculosis. Over the course of intensive phase therapy, patients from African sites had substantially delayed and lower rates of culture conversion to negative in liquid media compared to non-African patients. We explored potential explanations of this finding. METHODS: In TBTC Study 28, protocol-correct patients (n = 328 provided spot sputum specimens for M. tuberculosis culture in liquid media, at baseline and weeks 2, 4, 6 and 8 of study therapy. We compared sputum culture conversion for African and non-African patients stratified by four baseline measures of disease severity: AFB smear quantification, extent of disease on chest radiograph, cavity size and the number of days to detection of M. tuberculosis in liquid media using the Kaplan-Meier product-limit method. We evaluated specimen processing and culture procedures used at 29 study laboratories serving 27 sites. RESULTS: African TB patients had more extensive disease at enrollment than non-African patients. However, African patients with the least disease by the 4 measures of disease severity had conversion rates on liquid media that were substantially lower than conversion rates in non-African patients with the greatest extent of disease. HIV infection, smoking and diabetes did not explain delayed conversion in Africa. Some inter-site variation in laboratory processing and culture procedures within accepted practice for clinical diagnostic laboratories was found. CONCLUSIONS: Compared with patients from non-African sites, African patients being treated for TB had delayed sputum culture conversion and lower sputum conversion rates in liquid media that were not explained by baseline severity of disease, HIV status, age, smoking, diabetes or race. Further investigation is warranted into whether modest

  8. Real-Time Pretreatment Review Limits Unacceptable Deviations on a Cooperative Group Radiation Therapy Technique Trial: Quality Assurance Results of RTOG 0933

    Energy Technology Data Exchange (ETDEWEB)

    Gondi, Vinai, E-mail: vgondi@chicagocancer.org [Cadence Brain Tumor Center and CDH Proton Center, Warrenville, Illinois (United States); University of Wisconsin School of Medicine & Public Health, Madison, Wisconsin (United States); Cui, Yunfeng [Duke University School of Medicine, Durham, North Carolina (United States); Mehta, Minesh P. [University of Maryland School of Medicine, Baltimore, Maryland (United States); Manfredi, Denise [Radiation Therapy Oncology Group—RTQA, Philadelphia, Pennsylvania (United States); Xiao, Ying; Galvin, James M. [Thomas Jefferson University Hospital, Philadelphia, Pennsylvania (United States); Rowley, Howard [University of Wisconsin School of Medicine & Public Health, Madison, Wisconsin (United States); Tome, Wolfgang A. [Montefiore Medical Center and Institute for Onco-Physics, Albert Einstein College of Medicine of Yeshiva University, Bronx, New York (United States)

    2015-03-01

    Purpose: RTOG 0933 was a phase II trial of hippocampal avoidance during whole brain radiation therapy for patients with brain metastases. The results demonstrated improvement in short-term memory decline, as compared with historical control individuals, and preservation of quality of life. Integral to the conduct of this trial were quality assurance processes inclusive of pre-enrollment credentialing and pretreatment centralized review of enrolled patients. Methods and Materials: Before enrolling patients, all treating physicians and sites were required to successfully complete a “dry-run” credentialing test. The treating physicians were credentialed based on accuracy of magnetic resonance imaging–computed tomography image fusion and hippocampal and normal tissue contouring, and the sites were credentialed based on protocol-specified dosimetric criteria. Using the same criteria, pretreatment centralized review of enrolled patients was conducted. Physicians enrolling 3 consecutive patients without unacceptable deviations were permitted to enroll further patients without pretreatment review, although their cases were reviewed after treatment. Results: In all, 113 physicians and 84 sites were credentialed. Eight physicians (6.8%) failed hippocampal contouring on the first attempt; 3 were approved on the second attempt. Eight sites (9.5%) failed intensity modulated radiation therapy planning on the first attempt; all were approved on the second attempt. One hundred thirteen patients were enrolled in RTOG 0933; 100 were analyzable. Eighty-seven cases were reviewed before treatment; 5 (5.7%) violated the eligibility criteria, and 21 (24%) had unacceptable deviations. With feedback, 18 cases were approved on the second attempt and 2 cases on the third attempt. One patient was treated off protocol. Twenty-two cases were reviewed after treatment; 1 (4.5%) violated the eligibility criteria, and 5 (23%) had unacceptable deviations. Conclusions: Although >95% of the

  9. Stroke Trials Registry

    Science.gov (United States)

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

  10. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Z > Participating in Clinical Trials: About Clinical Trials In This Topic About Clinical Trials Risks and Benefits ... of this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study ...

  11. Validation of a real-time PCR based method for detection of Clostridium botulinum types C, D and their mosaic variants C-D and D-C in a multicenter collaborative trial.

    Science.gov (United States)

    Woudstra, Cedric; Skarin, Hanna; Anniballi, Fabrizio; Auricchio, Bruna; De Medici, Dario; Bano, Luca; Drigo, Ilenia; Hansen, Trine; Löfström, Charlotta; Hamidjaja, Raditijo; van Rotterdam, Bart J; Koene, Miriam; Bäyon-Auboyer, Marie-Hélène; Buffereau, Jean-Philippe; Fach, Patrick

    2013-08-01

    Two real-time PCR arrays based on the GeneDisc(®) cycler platform (Pall-GeneDisc Technologies) were evaluated in a multicenter collaborative trial for their capacity to specifically detect and discriminate Clostridium botulinum types C, D and their mosaic variants C-D and D-C that are associated with avian and mammalian botulism. The GeneDisc(®) arrays developed as part of the DG Home funded European project 'AnibioThreat' were highly sensitive and specific when tested on pure isolates and naturally contaminated samples (mostly clinical specimen from avian origin). Results of the multicenter collaborative trial involving eight laboratories in five European Countries (two laboratories in France, Italy and The Netherlands, one laboratory in Denmark and Sweden), using DNA extracts issued from 33 pure isolates and 48 naturally contaminated samples associated with animal botulism cases, demonstrated the robustness of these tests. Results showed a concordance among the eight laboratories of 99.4%-100% for both arrays. The reproducibility of the tests was high with a relative standard deviation ranging from 1.1% to 7.1%. Considering the high level of agreement achieved between the laboratories these PCR arrays constitute robust and suitable tools for rapid detection of C. botulinum types C, D and mosaic types C-D and D-C. These are the first tests for C. botulinum C and D that have been evaluated in a European multicenter collaborative trial.

  12. The impact of Curtin University's activity, food and attitudes program on physical activity, sedentary time and fruit, vegetable and junk food consumption among overweight and obese adolescents: a waitlist controlled trial.

    Directory of Open Access Journals (Sweden)

    Leon M Straker

    Full Text Available BACKGROUND: To determine the effects of participation in Curtin University's Activity, Food and Attitudes Program (CAFAP, a community-based, family-centered behavioural intervention, on the physical activity, sedentary time, and healthy eating behaviours of overweight and obese adolescents. METHODS: In this waitlist controlled clinical trial in Western Australia, adolescents (n = 69, 71% female, mean age 14.1 (SD 1.6 years and parents completed an 8-week intervention followed by 12 months of telephone and text message support. Assessments were completed at baseline, before beginning the intervention, immediately following the intervention, and at 3-, 6-, and 12- months follow-up. The primary outcomes were physical activity and sedentary time assessed by accelerometers and servings of fruit, vegetables and junk food assessed by 3-day food records. RESULTS: During the intensive 8-week intervention sedentary time decreased by -5.1 min/day/month (95% CI: -11.0, 0.8 which was significantly greater than the rate of change during the waitlist period (p = .014. Moderate physical activity increased by 1.8 min/day/month (95% CI: -0.04, 3.6 during the intervention period, which was significantly greater than the rate of change during the waitlist period (p = .041. Fruit consumption increased during the intervention period (monthly incidence rate ratio (IRR 1.3, 95% CI: 1.10, 1.56 and junk food consumption decreased (monthly IRR 0.8, 95% CI: 0.74, 0.94 and these changes were different to those seen during the waitlist period (p = .004 and p = .020 respectively. CONCLUSIONS: Participating in CAFAP appeared to have a positive influence on the physical activity, sedentary and healthy eating behaviours of overweight and obese adolescents and many of these changes were maintained for one year following the intensive intervention. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry ACTRN12611001187932.

  13. The CYTONOX trial

    DEFF Research Database (Denmark)

    Gade, Christina; Mikus, Gerd; Christensen, Hanne Rolighed

    2016-01-01

    will be defined by using well-tested probes; midazolam, chlorzoxazone and caffeine. Each of the probes will be administered as a single dose. Subsequently, blood and urine samples will be collected at pre-specified times. CONCLUSION: The aim of the CYTONOX trial is to investigate the in vivo activity of CYP3A4...

  14. The effectiveness of sit-stand workstations for changing office workers' sitting time: results from the Stand@Work randomized controlled trial pilot

    National Research Council Canada - National Science Library

    Chau, Josephine Y; Daley, Michelle; Dunn, Scott; Srinivasan, Anu; Do, Anna; Bauman, Adrian E; van der Ploeg, Hidde P

    2014-01-01

    Prolonged sitting time is detrimental for health. Individuals with desk-based occupations tend to sit a great deal and sit-stand workstations have been identified as a potential strategy to reduce sitting time...

  15. Classical swine fever virus detection: results of a real-time reverse transcription polymerase chain reaction ring trial conducted in the framework of the European network of excellence for epizootic disease diagnosis and control

    DEFF Research Database (Denmark)

    Hoffmann, Bernd; Blome, Sandra; Bonilauri, Paolo

    2011-01-01

    The current study reports on a real-time reverse transcription polymerase chain reaction (real-time RT-PCR) ring trial for the detection of Classical swine fever virus (CSFV) genomic RNA undertaken by 10 European laboratories. All laboratories were asked to use their routine in-house real-time RT......-PCR protocols and a standardized protocol commonly used by the Friedrich-Loeffler-Institute (FLI) on a panel of well-characterized samples. In general, all participants produced results within the acceptable range. The FLI assay, several in-house assays, and the commercial kits had high analytical sensitivity...... and specificity values. Nevertheless, some in-house systems had unspecific reactions or suboptimal sensitivity with only a single CSFV genotype. Follow-up actions involved either improvement of suboptimal assays or replacement of specific laboratory assays with the FLI protocol, with or without modifications...

  16. Study on the calculation methods of equivalent time%等效时间计算方法研究

    Institute of Scientific and Technical Information of China (English)

    刘吉福; 郑刚; 安关峰

    2012-01-01

    公路工程通常采用超载预压减少路基的工后次固结沉降,利用等效时间可以合理考虑超载预压减少工后次固结沉降的作用.为此,对等效时间的计算方法进行了研究,在等效时间已有计算方法的基础上提出了简化计算方法.算例计算结果表明,简化方法的计算结果与已有计算方法的基本相同,而且简单适用,有利于等效时间理论的推广应用和工后沉降的控制.%Surcharge preloading is often used to decrease post-construction secondary consolidation settlement of highway embankment. This effect of surcharge preloading can be taken into account reasonably by use of equivalent time. In order to consider the effect of surcharge preloading, calcu-lation methods of equivalent time are studied. A simplified method to calculate equivalent time is proposed based on present methods. The results given by the simplified method are nearly equal to those from present methods. The simplified method will benefit the application of equivalent time theory and the control of post-construction settlement.

  17. A tailless timing belt climbing platform utilizing dry adhesives with mushroom caps

    Science.gov (United States)

    Krahn, J.; Liu, Y.; Sadeghi, A.; Menon, C.

    2011-11-01

    In many instances, a climbing robot that utilizes dry adhesives as an attachment method may be found to be very useful due to the inherent nature of biomimetic fibrillar dry adhesives in the applications of space, security, surveillance and nuclear reactor cleaning and maintenance. In this paper, a novel tank-like modular robot is developed that does not require a tail to provide a preload to the front of the robot while climbing. Biomimetic fibrillar dry adhesives with mushroom caps manufactured into belts are used as an attachment method. The manufacturing of the dry adhesive belts is discussed and the adhesion properties are examined. The timing belt based climbing platform (TBCP-II) utilizes two tank-like modules connected with an active joint with continual surface-robot distance measuring providing feedback for active adhesive preloading. The mechanical, electronic and software design is discussed. Reliable vertical surface climbing is achieved and the preloading strategy and response is examined. TBCP-II is shown to be capable of both horizontal to vertical and vertical to horizontal surface transfers over both inside and outside corners.

  18. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... treatment, screening, diagnostic, prevention, and supportive care trials. Treatment Trials In treatment trials, researchers may gather information about experimental treatments, ...

  19. The Trial

    Science.gov (United States)

    Bryant, Jen

    2004-01-01

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

  20. Follicle-stimulating hormone administered at the time of human chorionic gonadotropin trigger improves oocyte developmental competence in in vitro fertilization cycles: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Lamb, Julie D; Shen, Shehua; McCulloch, Charles; Jalalian, Liza; Cedars, Marcelle I; Rosen, Mitchell P

    2011-04-01

    To determine whether an additional follicle-stimulating hormone (FSH) bolus administered at the time of the human chorionic gonadotropin (hCG) trigger can improve the developmental competence of the oocyte. Randomized, double-blind, placebo-controlled, clinical trial. Academic medical center. Women undergoing a long agonist suppression in vitro fertilization (IVF) protocol for treatment of infertility. FSH bolus at time of hCG trigger versus placebo. Primary outcome; fertilization; secondary outcomes: oocyte recovery, implantation rate, and clinical and ongoing pregnancy/live birth rates. A total of 188 women (mean age: 36.2 years; range: 25 to 40 years) were randomized. Fertilization (2PN/#oocyte) was statistically significantly improved in the treatment arm (63% vs. 55%) as was the likelihood of oocyte recovery (70% vs. 57%). There was no statistically significant difference in clinical pregnancy rate (56.8% vs. 46.2%) or ongoing/live birth rate (51.6% vs. 43.0%). Improvements in IVF success rates have largely been due to optimization of embryo culture and stimulation protocols; less attention has been directed toward methods to improve induction of final oocyte maturation. This was the first randomized, double-blind, placebo-controlled trial to modify the ovulation trigger to improve oocyte competence, as demonstrated by the statistically significant improvement in fertilization. Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  1. Physical activity, sedentary time and gain in overall and central body fat : 7-year follow-up of the ProActive trial cohort

    NARCIS (Netherlands)

    Golubic, R.; Wijndaele, K.; Sharp, S. J.; Simmons, R. K.; Griffin, S. J.; Wareham, N. J.; Ekelund, U.; Brage, S.; de Jong, C.

    OBJECTIVE: The objective of this study is to examine the independent associations of time spent in moderate-to-vigorous physical activity (MVPA) and sedentary (SED-time), with total and abdominal body fat (BF), and the bidirectionality of these associations in adults at high risk of type 2 diabetes.

  2. Lack of effect of shorter turnaround time of microbiological procedures on clinical outcomes : a randomised controlled trial among hospitalised patients in the Netherlands

    NARCIS (Netherlands)

    Bruins, M; Oord, H; Bloembergen, P; Wolfhagen, M; Casparie, A; Degener, J; Ruijs, G

    2005-01-01

    Shortening the turnaround time of microbiological procedures was associated with an improved clinical outcome in two studies performed in the USA. To study the clinical impact of a shortened turnaround time in a northwest European setting in which an automated system was used for bacterial identific

  3. Point of care technology or standard laboratory service in an emergency department: is there a difference in time to action? A randomised trial

    DEFF Research Database (Denmark)

    Backer Mogensen, Christian; Borch, Anders; Brandslund, Ivan

    2011-01-01

    Emergency Departments (ED) have a high flow of patients and time is often crucial. New technologies for laboratory analysis have been developed, including Point of Care Technologies (POCT), which can reduce the transport time and time of analysis significantly compared with central laboratory...... services. However, the question is if the time to clinical action is also reduced if a decisive laboratory answer is available during the first contact between the patient and doctor. The present study addresses this question: Does a laboratory answer, provided by POCT to the doctor who first attends...... the patient on admission, change the time to clinical decision in commonly occurring diseases in an ED compared with the traditional service from a central laboratory?...

  4. A single-arm trial indirect comparison investigation: a proof-of-concept method to predict venous leg ulcer healing time for a new acellular synthetic matrix matched to standard care control.

    Science.gov (United States)

    Shannon, Ronald; Nelson, Andrea

    2017-08-01

    To compare data on time to healing from two separate cohorts: one treated with a new acellular synthetic matrix plus standard care (SC) and one matched from four large UK pragmatic, randomised controlled trials [venous leg ulcer (VLU) evidence network]. We introduce a new proof-of-concept strategy to a VLU clinical evidence network, propensity score matching and sensitivity analysis to predict the feasibility of the new acellular synthetic matrix plus SC for success in future randomised, controlled clinical trials. Prospective data on chronic VLUs from a safety and effectiveness study on an acellular synthetic matrix conducted in one wound centre in the UK (17 patients) and three wound centres in Australia (36 patients) were compared retrospectively to propensity score-matched data from patients with comparable leg ulcer disease aetiology, age, baseline ulcer area, ulcer duration, multi-layer compression bandaging and majority of care completed in specialist wound centres (average of 1 visit per week), with the outcome measures at comparable follow-up periods from patients enrolled in four prospective, multicentre, pragmatic, randomised studies of venous ulcers in the UK (the comparison group; VLU evidence network). Analysis using Kaplan-Meier survival curves showed a mean healing time of 73·1 days for ASM plus SC (ASM) treated ulcers in comparison with 83·5 days for comparison group ulcers treated with SC alone (Log rank test, χ(2) 5·779, P = 0·016) within 12 weeks. Sensitivity analysis indicates that an unobserved covariate would have to change the odds of healing for SC by a factor of 1·1 to impact the baseline results. Results from this study predict a significant effect on healing time when using a new ASM as an adjunct to SC in the treatment of non-healing venous ulcers in the UK, but results are sensitive to unobserved covariates that may be important in healing time comparison. © 2016 Medicalhelplines.com Inc and John Wiley & Sons Ltd.

  5. Participating in Clinical Trials

    Science.gov (United States)

    ... this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical ... to treat or cure a disease. Phases of Clinical Trials Clinical trials of drugs are usually described based ...

  6. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Usually, trial participants must show signs of the disease or condition before they can join this type of trial. Prevention Trials Click for more information In prevention trials, ...

  7. Timing of granulocyte-colony stimulating factor treatment after acute myocardial infarction and recovery of left ventricular function: results from the STEMMI trial

    DEFF Research Database (Denmark)

    Overgaard, Mikkel; Ripa, Rasmus Sejersten; Wang, Yongzhong

    2010-01-01

    Granulocyte-colony stimulating factor (G-CSF) therapy after ST-elevation myocardial infarction (STEMI) have not demonstrated impact on systolic recovery compared to placebo. However, recent studies suggest that timing of G-CSF therapy is crucial.......Granulocyte-colony stimulating factor (G-CSF) therapy after ST-elevation myocardial infarction (STEMI) have not demonstrated impact on systolic recovery compared to placebo. However, recent studies suggest that timing of G-CSF therapy is crucial....

  8. Two-Arm Randomized Pilot Intervention Trial to Decrease Sitting Time and Increase Sit-To-Stand Transitions in Working and Non-Working Older Adults.

    Science.gov (United States)

    Kerr, Jacqueline; Takemoto, Michelle; Bolling, Khalisa; Atkin, Andrew; Carlson, Jordan; Rosenberg, Dori; Crist, Katie; Godbole, Suneeta; Lewars, Brittany; Pena, Claudia; Merchant, Gina

    2016-01-01

    Excessive sitting has been linked to poor health. It is unknown whether reducing total sitting time or increasing brief sit-to-stand transitions is more beneficial. We conducted a randomized pilot study to assess whether it is feasible for working and non-working older adults to reduce these two different behavioral targets. Thirty adults (15 workers and 15 non-workers) age 50-70 years were randomized to one of two conditions (a 2-hour reduction in daily sitting or accumulating 30 additional brief sit-to-stand transitions per day). Sitting time, standing time, sit-to-stand transitions and stepping were assessed by a thigh worn inclinometer (activPAL). Participants were assessed for 7 days at baseline and followed while the intervention was delivered (2 weeks). Mixed effects regression analyses adjusted for days within participants, device wear time, and employment status. Time by condition interactions were investigated. Recruitment, assessments, and intervention delivery were feasible. The 'reduce sitting' group reduced their sitting by two hours, the 'increase sit-to-stand' group had no change in sitting time (p sit-to-stand transition group increased their sit-to-stand transitions, the sitting group did not (p < .001). This study was the first to demonstrate the feasibility and preliminary efficacy of specific sedentary behavioral goals. clinicaltrials.gov NCT02544867.

  9. Improving medication adherence in diabetes type 2 patients through Real Time Medication Monitoring: a Randomised Controlled Trial to evaluate the effect of monitoring patients' medication use combined with short message service (SMS reminders

    Directory of Open Access Journals (Sweden)

    Bouvy Marcel L

    2011-01-01

    Full Text Available Abstract Background Innovative approaches are needed to support patients' adherence to drug therapy. The Real Time Medication Monitoring (RTMM system offers real time monitoring of patients' medication use combined with short message service (SMS reminders if patients forget to take their medication. This combination of monitoring and tailored reminders provides opportunities to improve adherence. This article describes the design of an intervention study aimed at evaluating the effect of RTMM on adherence to oral antidiabetics. Methods/Design Randomised Controlled Trial (RCT with two intervention arms and one control arm involving diabetes type 2 patients with suboptimal levels of adherence to oral antidiabetics (less than 80% based on pharmacy refill data. Patients in the first intervention arm use RTMM including SMS reminders and a personal webpage where they can monitor their medication use. Patients in the second intervention arm use RTMM without SMS reminders or webpage access. Patients in the control arm are not exposed to any intervention. Patients are randomly assigned to one of the three arms. The intervention lasts for six months. Pharmacy refill data of all patients are available from 11 months before, until 11 months after the start of the intervention. Primary outcome measure is adherence to oral antidiabetics calculated from: 1 data collected with RTMM, as a percentage of medication taken as prescribed, and as percentage of medication taken within the correct time interval, 2 refill data, taking the number of days for which oral antidiabetics are dispensed during the study period divided by the total number of days of the study period. Differences in adherence between the intervention groups and control group are studied using refill data. Differences in adherence between the two intervention groups are studied using RTMM data. Discussion The intervention described in this article consists of providing RTMM to patients with

  10. Effects of Improvisational Music Therapy vs Enhanced Standard Care on Symptom Severity Among Children With Autism Spectrum Disorder: The TIME-A Randomized Clinical Trial.

    Science.gov (United States)

    Bieleninik, Lucja; Geretsegger, Monika; Mössler, Karin; Assmus, Jörg; Thompson, Grace; Gattino, Gustavo; Elefant, Cochavit; Gottfried, Tali; Igliozzi, Roberta; Muratori, Filippo; Suvini, Ferdinando; Kim, Jinah; Crawford, Mike J; Odell-Miller, Helen; Oldfield, Amelia; Casey, Órla; Finnemann, Johanna; Carpente, John; Park, A-La; Grossi, Enzo; Gold, Christian

    2017-08-08

    Music therapy may facilitate skills in areas affected by autism spectrum disorder (ASD), such as social interaction and communication. To evaluate effects of improvisational music therapy on generalized social communication skills of children with ASD. Assessor-blinded, randomized clinical trial, conducted in 9 countries and enrolling children aged 4 to 7 years with ASD. Children were recruited from November 2011 to November 2015, with follow-up between January 2012 and November 2016. Enhanced standard care (n = 182) vs enhanced standard care plus improvisational music therapy (n = 182), allocated in a 1:1 ratio. Enhanced standard care consisted of usual care as locally available plus parent counseling to discuss parents' concerns and provide information about ASD. In improvisational music therapy, trained music therapists sang or played music with each child, attuned and adapted to the child's focus of attention, to help children develop affect sharing and joint attention. The primary outcome was symptom severity over 5 months, based on the Autism Diagnostic Observation Schedule (ADOS), social affect domain (range, 0-27; higher scores indicate greater severity; minimal clinically important difference, 1). Prespecified secondary outcomes included parent-rated social responsiveness. All outcomes were also assessed at 2 and 12 months. Among 364 participants randomized (mean age, 5.4 years; 83% boys), 314 (86%) completed the primary end point and 290 (80%) completed the last end point. Over 5 months, participants assigned to music therapy received a median of 19 music therapy, 3 parent counseling, and 36 other therapy sessions, compared with 3 parent counseling and 45 other therapy sessions for those assigned to enhanced standard care. From baseline to 5 months, mean ADOS social affect scores estimated by linear mixed-effects models decreased from 14.08 to 13.23 in the music therapy group and from 13.49 to 12.58 in the standard care group (mean difference, 0

  11. Evaluating time between birth to cry or bag and mask ventilation using mobile delivery room timers in India: the NICHD Global Network's Helping Babies Breathe Trial.

    Science.gov (United States)

    Somannavar, Manjunath S; Goudar, Shivaprasad S; Revankar, Amit P; Moore, Janet L; McClure, Elizabeth M; Destefanis, Pablo; DeCain, Martha; Goco, Norman; Wright, Linda L

    2015-08-06

    The Golden Minute®, the first minute following birth of a newborn, is a critical period for establishing ventilation after delivery, as emphasized in the Helping Babies Breathe® and other resuscitation training programs. Previous studies have reinforced training through observers' evaluation of this time period; although observation is useful for research, it may not be a sustainable method to support resuscitation practice in low-resource settings where few birth attendants are available. In order to reinforce resuscitation within The Golden Minute®, we sought to develop a simple mobile delivery-room timer on an Android cell phone platform for birth attendants to use at the time of delivery. We developed and evaluated a mobile delivery room timer to document the time interval from birth to the initiation of newborn crying/spontaneous respiration or bag and mask ventilation in a convenience sample of women who delivered in five hospitals in Karnataka, India. The mobile delivery room timer is an Android cell phone-based application that recorded key events including crowning, delivery, and crying/spontaneous respiration or bag and mask ventilation. The mobile delivery room timer recorded the birth attendant verbally indicating the time of crowning, birth-(defined as when the entire baby was delivered), crying/spontaneous respiration or bag and mask ventilation. The mobile delivery room timer results were validated in a subsample by a trained observer (nurse) who independently recorded the time between delivery and initiation of crying/spontaneous respiration or bag and mask ventilation. Of the total 4,597 deliveries, 2,107 (46%) were timed; a sample (n = 438) of these deliveries was also observed by a trained nurse. There was high concordance between the mobile delivery room timer and observed time elapsed between birth and crying/spontaneous respiration or ventilation (correlation =0.94, p delivery room timer application was feasible to use during delivery and

  12. A pilot, family-based randomised controlled trial to reduce screen time and unhealthy snacking in children and their parents: Kids FIRST

    Directory of Open Access Journals (Sweden)

    Natalie Pearson

    2015-10-01

    To our knowledge, Kids FIRST is the first pilot RCT to examine the effectiveness of behaviour change strategies for reducing children’s screen-time and unhealthy snacking. The integration of consistent, evidence-based and theory informed strategies and messages to children and their parents in the family and school settings are critical components of this pilot study. The results of this study will provide evidence on the feasibility and effectiveness of single versus multiple behaviour intervention strategies. If shown to be feasible and effective, the Kids FIRST study may have a significant impact on the home environment and parenting practices relating to screen time and unhealthy snacking.

  13. The impact of Curtin University's activity, food and attitudes program on physical activity, sedentary time and fruit, vegetable and junk food consumption among overweight and obese adolescents: a waitlist controlled trial.

    Science.gov (United States)

    Straker, Leon M; Howie, Erin K; Smith, Kyla L; Fenner, Ashley A; Kerr, Deborah A; Olds, Tim S; Abbott, Rebecca A; Smith, Anne J

    2014-01-01

    To determine the effects of participation in Curtin University's Activity, Food and Attitudes Program (CAFAP), a community-based, family-centered behavioural intervention, on the physical activity, sedentary time, and healthy eating behaviours of overweight and obese adolescents. In this waitlist controlled clinical trial in Western Australia, adolescents (n = 69, 71% female, mean age 14.1 (SD 1.6) years) and parents completed an 8-week intervention followed by 12 months of telephone and text message support. Assessments were completed at baseline, before beginning the intervention, immediately following the intervention, and at 3-, 6-, and 12- months follow-up. The primary outcomes were physical activity and sedentary time assessed by accelerometers and servings of fruit, vegetables and junk food assessed by 3-day food records. During the intensive 8-week intervention sedentary time decreased by -5.1 min/day/month (95% CI: -11.0, 0.8) which was significantly greater than the rate of change during the waitlist period (p = .014). Moderate physical activity increased by 1.8 min/day/month (95% CI: -0.04, 3.6) during the intervention period, which was significantly greater than the rate of change during the waitlist period (p = .041). Fruit consumption increased during the intervention period (monthly incidence rate ratio (IRR) 1.3, 95% CI: 1.10, 1.56) and junk food consumption decreased (monthly IRR 0.8, 95% CI: 0.74, 0.94) and these changes were different to those seen during the waitlist period (p = .004 and p = .020 respectively). Participating in CAFAP appeared to have a positive influence on the physical activity, sedentary and healthy eating behaviours of overweight and obese adolescents and many of these changes were maintained for one year following the intensive intervention. Australia and New Zealand Clinical Trials Registry ACTRN12611001187932.

  14. The GO-ACTIWE randomized controlled trial - An interdisciplinary study designed to investigate the health effects of active commuting and leisure time physical activity

    DEFF Research Database (Denmark)

    Rosenkilde, Mads; Petersen, Martin Bæk; Gram, Anne Sofie

    2017-01-01

    in transport (bicycling) or leisure time domains (moderate or vigorous intensity endurance exercise). We included 188 overweight and class 1 obese sedentary women and men (20-45years) of which 130 were randomized to either sedentary controls (n=18), active commuting (n=35) or moderate (n=39) or vigorous (n=38...

  15. Updating prognosis in primary biliary cirrhosis using a time-dependent Cox regression model. PBC1 and PBC2 trial groups

    DEFF Research Database (Denmark)

    Christensen, E; Altman, D G; Neuberger, J

    1993-01-01

    BACKGROUND: The precision of current prognostic models in primary biliary cirrhosis (PBC) is rather low, partly because they are based on data from just one time during the course of the disease. The aim of this study was to design a new, more precise prognostic model by incorporating follow-up d...

  16. Time to treatment with intravenous alteplase and outcome in stroke: an updated pooled analysis of ECASS, ATLANTIS, NINDS, and EPITHET trials

    DEFF Research Database (Denmark)

    Lees, Kennedy R; Bluhmki, Erich; von Kummer, Rüdiger;

    2010-01-01

    Early administration of intravenous recombinant tissue plasminogen activator (rt-PA) after ischaemic stroke improves outcome. Previous analysis of combined data from individual patients suggested potential benefit beyond 3 h from stroke onset. We re-examined the effect of time to treatment with i...

  17. Leveraging time and learning style, iPod vs. realtime attendance at a series of medicine residents conferences: a randomised controlled