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Sample records for blind cross-over design

  1. Thermogenic effect of meltdown RTD™ energy drink in young healthy women: a double blind, cross-over design study

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    Faigenbaum Avery D

    2009-12-01

    Full Text Available Abstract Background The purpose of this study was to examine the acute metabolic effects of a high-energy drink in healthy, physically-active women. Methods Ten women (20.4 ± 0.70 y; 166.9 ± 7.2 cm; 67.0 ± 7.0 kg; 29.6 ± 6.5% body fat underwent two testing sessions administered in a randomized and double-blind fashion. Subjects reported to the laboratory in a 3-hr post-absorptive state and were provided either 140 ml of the high-energy drink (SUP; commercially marketed as Meltdown RTD™ or placebo (P. Subjects consumed two 70 ml doses of SUP or P, separated by 30 min and rested in a semi-recumbent position for 3 hours. Resting oxygen consumption (VO2 and heart rate (HR were determined every 5 min during the first 30 min and every 10 min during the next 150 min. Blood pressure (BP was determined every 15 min during the first 30 min and every 30 min thereafter. Area under the curve (AUC analysis was computed for VO2, whereas a 3-hour average and hourly averages were calculated for respiratory quotient (RQ, total kcal, HR, BP, and profile of mood states (POMS. Results AUC analysis revealed a 10.8% difference (p = 0.03 in VO2 between SUP and P. No difference in VO2 was seen between the groups in the first hour, but VO2 in SUP was significantly greater than P in the second (13.9%, p = 0.01 and third hours (11.9%, p = 0.03. A difference (p = 0.03 in energy expenditure was seen between SUP (1.09 ± 0.10 kcal·min-1 and P (0.99 ± 0.09 kcal·min-1 for the 3-hour period. Although no difference in energy expenditure was seen in the first hour, significant differences between SUP and P were observed in the second (1.10 ± 0.11 kcal·min-1 and 0.99 ± 0.09 kcal·min-1, respectively; p = 0.02 and third hour (1.08 ± 0.11 kcal·min-1 and 0.99 ± 0.09 kcal·min-1, respectively; p = 0.05. Average systolic BP was significantly higher (p = 0.007 for SUP (110.0 ± 3.9 mmHg compared to P (107.3 ± 4.4 mmHg. No differences were seen in HR, diastolic BP, or POMS

  2. The Impact of Oxytocin on Food Intake and Emotion Recognition in Patients with Eating Disorders: A Double Blind Single Dose Within-Subject Cross-Over Design.

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    Kim, Youl-Ri; Eom, Jin-Sup; Yang, Jae-Won; Kang, Jiwon; Treasure, Janet

    2015-01-01

    Social difficulties and problems related to eating behaviour are common features of both anorexia nervosa (AN) and bulimia nervosa (BN). The aim of this study was to examine the impact of intranasal oxytocin on consummatory behaviour and emotional recognition in patients with AN and BN in comparison to healthy controls. A total of 102 women, including 35 patients with anorexia nervosa (AN), 34 patients with bulimia nervosa (BN), and 33 healthy university students of comparable age and intelligence, participated in a double-blind, single dose placebo-controlled cross-over study. A single dose of intranasal administration of oxytocin (40 IU) (or a placebo) was followed by an emotional recognition task and an apple juice drink. Food intake was then recorded for 24 hours post-test. Oxytocin produced no significant change in appetite in the acute or 24 hours free living settings in healthy controls, whereas there was a decrease in calorie consumption over 24 hours in patients with BN. Oxytocin produced a small increase in emotion recognition sensitivity in healthy controls and in patients with BN, In patients with AN, oxytocin had no effect on emotion recognition sensitivity or on consummatory behaviour. The impact of oxytocin on appetite and social cognition varied between people with AN and BN. A single dose of intranasal oxytocin decreased caloric intake over 24 hours in people with BN. People with BN showed enhanced emotional sensitivity under oxytocin condition similar to healthy controls. Those effects of oxytocin were not found in patients with AN. ClinicalTrials.gov KCT00000716.

  3. The Impact of Oxytocin on Food Intake and Emotion Recognition in Patients with Eating Disorders: A Double Blind Single Dose Within-Subject Cross-Over Design

    Science.gov (United States)

    Kim, Youl-Ri; Eom, Jin-Sup; Yang, Jae-Won; Kang, Jiwon; Treasure, Janet

    2015-01-01

    Background and Aim Social difficulties and problems related to eating behaviour are common features of both anorexia nervosa (AN) and bulimia nervosa (BN). The aim of this study was to examine the impact of intranasal oxytocin on consummatory behaviour and emotional recognition in patients with AN and BN in comparison to healthy controls. Materials A total of 102 women, including 35 patients with anorexia nervosa (AN), 34 patients with bulimia nervosa (BN), and 33 healthy university students of comparable age and intelligence, participated in a double-blind, single dose placebo-controlled cross-over study. A single dose of intranasal administration of oxytocin (40 IU) (or a placebo) was followed by an emotional recognition task and an apple juice drink. Food intake was then recorded for 24 hours post-test. Results Oxytocin produced no significant change in appetite in the acute or 24 hours free living settings in healthy controls, whereas there was a decrease in calorie consumption over 24 hours in patients with BN. Oxytocin produced a small increase in emotion recognition sensitivity in healthy controls and in patients with BN, In patients with AN, oxytocin had no effect on emotion recognition sensitivity or on consummatory behaviour. Conclusions The impact of oxytocin on appetite and social cognition varied between people with AN and BN. A single dose of intranasal oxytocin decreased caloric intake over 24 hours in people with BN. People with BN showed enhanced emotional sensitivity under oxytocin condition similar to healthy controls. Those effects of oxytocin were not found in patients with AN. Trial Registration ClinicalTrials.gov KCT0000716 PMID:26402337

  4. The Impact of Oxytocin on Food Intake and Emotion Recognition in Patients with Eating Disorders: A Double Blind Single Dose Within-Subject Cross-Over Design.

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    Youl-Ri Kim

    Full Text Available Social difficulties and problems related to eating behaviour are common features of both anorexia nervosa (AN and bulimia nervosa (BN. The aim of this study was to examine the impact of intranasal oxytocin on consummatory behaviour and emotional recognition in patients with AN and BN in comparison to healthy controls.A total of 102 women, including 35 patients with anorexia nervosa (AN, 34 patients with bulimia nervosa (BN, and 33 healthy university students of comparable age and intelligence, participated in a double-blind, single dose placebo-controlled cross-over study. A single dose of intranasal administration of oxytocin (40 IU (or a placebo was followed by an emotional recognition task and an apple juice drink. Food intake was then recorded for 24 hours post-test.Oxytocin produced no significant change in appetite in the acute or 24 hours free living settings in healthy controls, whereas there was a decrease in calorie consumption over 24 hours in patients with BN. Oxytocin produced a small increase in emotion recognition sensitivity in healthy controls and in patients with BN, In patients with AN, oxytocin had no effect on emotion recognition sensitivity or on consummatory behaviour.The impact of oxytocin on appetite and social cognition varied between people with AN and BN. A single dose of intranasal oxytocin decreased caloric intake over 24 hours in people with BN. People with BN showed enhanced emotional sensitivity under oxytocin condition similar to healthy controls. Those effects of oxytocin were not found in patients with AN.ClinicalTrials.gov KCT00000716.

  5. Melatonin improves sleep in children with epilepsy: randomized, double-blind cross-over study

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    Jain, Sejal V; Horn, Paul S; Simakajornboon, Narong; Beebe, Dean W; Holland, Katherine; Byars, Anna W; Glauser, Tracy A

    2015-01-01

    Objective Insomnia, especially maintenance insomnia is widely prevalent in epilepsy. Although melatonin is commonly used, limited data address its efficacy. We performed a randomized, double-blind, placebo-controlled, cross-over study to identify the effects of melatonin on sleep and seizure control in children with epilepsy. Methods Eleven pre-pubertal, developmentally normal children aged 6–11 years with epilepsy were randomized by software algorithm to receive placebo or 9 mg sustained release melatonin for 4 weeks, followed by a 1-week washout and 4-week crossover condition. The pharmacy performed blinding; patients, parents and study staff other than a statistician were blinded. Primary outcomes were sleep onset latency and wakefulness after sleep onset (WASO) measured on polysomnography. Secondary outcomes included seizure frequency, epileptiform spike density per hour of sleep on EEG and reaction time measures on psychomotor vigilance task. Statistical tests appropriate for cross-over designs were used for analysis. Results Data were analyzed from ten subjects who completed the study. Melatonin decreased sleep latency (Mean difference (MD): 11.4 min, p= 0.02) and WASO (MD 22 min, p=0.04) as compared to placebo. No worsening of spike density or seizure frequency was seen. Additionally, Slow-wave sleep duration and REM latency were increased with melatonin and REM sleep duration was decreased. These changes were statistically significant. Worsening of headache was noted in one subject with migraine on melatonin. Conclusion Sustained-release melatonin resulted in statistically significant decreases in sleep latency and WASO. No clear effects on seizures were observed but the study was too small to allow any conclusions to be drawn in this regard. PMID:25862116

  6. Double-blind cross-over evaluation of mazindol in the treatment of obese hypertensive patients.

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    Miach, P J; Thomson, W; Doyle, A E; Louis, W J

    1976-09-04

    The effect of mazindol (AN 448) on weight and blood pressure was evaluated in a double-blind cross-over trial in 28 obese hypertensive patients, whose blood pressure was under stable control with one or more of the common antihypertensive agents--diuretics, beta-blocking drugs and methyldopa. There was a statistically significant decrease in weight, but no significant change in blood pressure (systolic and diastolic) or pulse rate during active treatment. It was considered that the drug might be of benefit to some patients, provided that they were properly motivated to adhere to the dietary regime.

  7. The effect of levetiracetam on focal nocturnal epileptiform activity during sleep--a placebo-controlled double-blind cross-over study.

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    Larsson, Pål Gunnar; Bakke, Kristin A; Bjørnæs, Helge; Heminghyt, Einar; Rytter, Elisif; Brager-Larsen, Line; Eriksson, Ann-Sofie

    2012-05-01

    Electric Status Epilepticus during Sleep (ESES) occurs in children with and without epilepsy. It may be related to disturbances as autism spectrum disorder, attention-deficit hyperactivity disorder and acquired aphasia (Landau-Kleffner syndrome). Antiepileptic drug (AED) treatment has been reported in small studies without placebo control. This study was designed to assess AED effect in a placebo-controlled double-blind cross-over study. Levetiracetam (LEV) was chosen based on clinical evidence. Eighteen patients fulfilled the inclusion criteria. The mean spike index at baseline was 56, falling to a mean of 37 at the end of the LEV treatment period. Assessed with a 2-way ANOVA, there is a significant treatment effect (pdouble-blind cross-over study for any AED in patients with ESES. The effect of LEV is comparable with its effect in treatment of epileptic seizures. Copyright © 2012 Elsevier Inc. All rights reserved.

  8. Salivary Oxytocin Concentrations in Males following Intranasal Administration of Oxytocin: A Double-Blind, Cross-Over Study.

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    Daughters, Katie; Manstead, Antony S R; Hubble, Kelly; Rees, Aled; Thapar, Anita; van Goozen, Stephanie H M

    2015-01-01

    The use of intranasal oxytocin (OT) in research has become increasingly important over the past decade. Although researchers have acknowledged a need for further investigation of the physiological effects of intranasal administration, few studies have actually done so. In the present double-blind cross-over study we investigated the longevity of a single 24 IU dose of intranasal OT measured in saliva in 40 healthy adult males. Salivary OT concentrations were significantly higher in the OT condition, compared to placebo. This significant difference lasted until the end of testing, approximately 108 minutes after administration, and peaked at 30 minutes. Results showed significant individual differences in response to intranasal OT administration. To our knowledge this is the largest and first all-male within-subjects design study to demonstrate the impact of intranasal OT on salivary OT concentrations. The results are consistent with previous research in suggesting that salivary OT is a valid matrix for OT measurement. The results also suggest that the post-administration 'wait-time' prior to starting experimental tasks could be reduced to 30 minutes, from the 45 minutes typically used, thereby enabling testing during peak OT concentrations. Further research is needed to ascertain whether OT concentrations after intranasal administration follow similar patterns in females, and different age groups.

  9. Salivary Oxytocin Concentrations in Males following Intranasal Administration of Oxytocin: A Double-Blind, Cross-Over Study.

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    Katie Daughters

    Full Text Available The use of intranasal oxytocin (OT in research has become increasingly important over the past decade. Although researchers have acknowledged a need for further investigation of the physiological effects of intranasal administration, few studies have actually done so. In the present double-blind cross-over study we investigated the longevity of a single 24 IU dose of intranasal OT measured in saliva in 40 healthy adult males. Salivary OT concentrations were significantly higher in the OT condition, compared to placebo. This significant difference lasted until the end of testing, approximately 108 minutes after administration, and peaked at 30 minutes. Results showed significant individual differences in response to intranasal OT administration. To our knowledge this is the largest and first all-male within-subjects design study to demonstrate the impact of intranasal OT on salivary OT concentrations. The results are consistent with previous research in suggesting that salivary OT is a valid matrix for OT measurement. The results also suggest that the post-administration 'wait-time' prior to starting experimental tasks could be reduced to 30 minutes, from the 45 minutes typically used, thereby enabling testing during peak OT concentrations. Further research is needed to ascertain whether OT concentrations after intranasal administration follow similar patterns in females, and different age groups.

  10. THERAPEUTIC EQUIVALENCE OF ORIGINAL CLOPIDOGREL (PLAVIX AND ITS GENERIC (EGITROMB. RESULTS OF COMPARATIVE RANDOMIZED CROSS-OVER BLIND STUDY

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    V. V. Yakusevich

    2011-01-01

    Full Text Available Aim. To study therapeutic equivalence (efficacy, safety and tolerability of original clopidogrel (Plavix and its generic (Egitromb in patients of high cardiovascular risk. Material and methods. Thirty one patients with coronary heart disease and indications for clopidogrel therapy were involved into the randomized cross-over blind study. Half of the patients received original clopidogrel (75 mg daily during the first 2 weeks and then they received generic clopidogrel in the same dose during next 2 weeks. Another half of the patients received the drugs in reverse order. Antiplatelet activity of Plavix and Egitromb was estimated by effects on ADP-induced platelet aggregation initially and after 2 weeks of treatment with each drug. Study blinding was provided by the following approach: doctors of cardiology clinic performed clinical monitoring and drug distribution; coded blood samples for platelet aggregation assessment were studied in independent laboratory of thrombosis; statistical data analysis was performed by biostatistics expert in other research center. Results. 2-week therapy with each drug led to a significant decrease of ADP-induced platelet aggregation which remained low after switching from original drug to generic and vice versa. Aggregation dynamics did not depend on the first administered drug. There were no significant differences between aggregation changes as a result of treatment with original or generic drug. No one adverse event was observed in association with both drugs therapy. Conclusion. Generic drug Egitromb (Egis, Hungary and original clopidogrel Plavix (Sanofi-Aventis, France have equivalent antiplatelet effect.

  11. Hemodiafiltration Improves Plasma 25-Hepcidin Levels: A Prospective, Randomized, Blinded, Cross-Over Study Comparing Hemodialysis and Hemodiafiltration

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    Bergur V. Stefánsson

    2012-03-01

    Full Text Available Background/Aims: Data from studies comparing the effect of hemodiafiltration (HDF and conventional hemodialysis (HD on clinically important outcomes are insufficient to support superiority of HDF. None of these studies has been participant-blinded. Methods: We performed a prospective, randomized, and patient-blinded cross-over study. Twenty patients on chronic HD received either HD for 2 months followed by post-dilution HDF for 2 months or in opposite order. A range of clinical parameters, as well as markers of inflammation, oxidative stress and iron metabolism was measured. Results: The two treatments were similar with respect to dialysis-related complications, quality of life, and the biomarkers of oxidative stress and inflammation. Compared to HD, 25-hepcidin and β2-microglobulin were 38 and 32%, respectively, lower after 60 days of HDF (p Conclusion: In short term, HDF is not superior to HD regarding dialysis-related complications. The higher ESA consumption observed with HDF can be explained by blood clotting in tubing and dialyzers, as more anticoagulation was needed with post-dilution HDF. In a longer perspective, lowering serum hepcidin levels may improve pathological iron homeostasis.

  12. Homeopathy for mental fatigue: lessons from a randomized, triple blind, placebo-controlled cross-over clinical trial

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    Dean Michael

    2012-10-01

    Full Text Available Abstract Background Difficulty in controlling attention can lead to mental fatigue in the healthy population. We identified one trial reporting a benefit in patients’ attention using a homeopathic formula preparation. One component of the preparation was potassium phosphate, widely available off the shelf as Kali phos 6x for cognitive problems. The aim of this exploratory trial was to assess the effectiveness of Kali phos 6x for attention problems associated with mental fatigue. Methods We recruited student and staff volunteers (University of York with self-reported mental fatigue, excluding any using homeopathy or prescribed stimulants, or with a diagnosis of chronic fatigue syndrome. In a triple blind, cross-over, placebo-controlled clinical trial, 86 volunteers were randomized to receive Kali phos 6x or identical placebo 10 minutes before taking a psychological test of attention (Stroop Colour-Word Test. One week later they were crossed over and took the other preparation before repeating the test. Results We found no evidence of a treatment effect in a comparison of Kali phos 6x with placebo (Kali phos minus placebo = −1.1 (95% CI −3.0 to 0.9, P = 0.3 Stroop score units, Cohen effect size = −0.17 even when allowing for a weak period effect with accuracy scores in the second period being higher than those in the first (P = 0.05. We observed a ceiling effect in the Stroop test which undermined our ability to interpret this result. Conclusions Kali phos 6x was not found to be effective in reducing mental fatigue. A ceiling effect in our primary outcome measure meant that we could not rule out a type II error. Thorough piloting of an adequate outcome measure could have led to an unequivocal result. Current Controlled Trials ISRCTN16521161

  13. Gabapentin in traumatic nerve injury pain: A randomized, double-blind, placebo-controlled, cross-over, multi-center study

    DEFF Research Database (Denmark)

    Gordh, Torsten E; Stubhaug, Audun; Jensen, Troels S

    2008-01-01

    A double-blind, randomized, placebo-controlled cross-over multi-center study was conducted to evaluate the efficacy and safety of gabapentin in the treatment of neuropathic pain caused by traumatic or postsurgical peripheral nerve injury, using doses up to 2400mg/day. The study comprised a run...

  14. Low doses of mirtazapine or quetiapine for transient insomnia : A randomised, double-blind, cross-over, placebo-controlled trial

    NARCIS (Netherlands)

    Karsten, Julie; Hagenauw, Loes A.; Kamphuis, Jeanine; Lancel, Marike

    Low doses of the antidepressant mirtazapine or the neuroleptic quetiapine are often prescribed off-label for insomnia. However, studies on the effects on sleep and hangover effects the following day are scarce. In this randomised, double-blind, cross-over, placebo-controlled trial, the influence of

  15. Comparative effects of artemisia vulgaris and charcoal moxa stimulating Zhongwan (CV 12) on body temperature in healthy participants: a cross-over single-blind randomized study.

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    Go, Ho-Yeon; Lee, Ju Ah; Park, Sunyoung; Park, Sunju; Park, Jeong-Su; Cheon, Chunhoo; Ko, Seong-Gyu; Kong, Kyung-Hwan; Jun, Chan-yong; Park, Jong-hyeong; Shin, Mi-Ran; Lee, Se-Hoon

    2015-10-01

    To evaluate the efficacy, safety, satisfaction, discomfort and patient preference of moxa cones of artemisia vulgaris and charcoal moxa. This comparative study of moxibustion treatment with Artemisia vulgaris and charcoal moxa cone stimulating Zhongwan (CV 12) is a cross-over single-blinded, randomized clinical trial. A total of 40 healthy subjects (24 males and 16 females) participated in this study. Two subjects dropped out of the trial. Thirty-eight subjects were treated with Artemisia vulgaris and charcoal moxa cones for 30 min in a cross-over design. After treatment, the patients underwent a 30 minute waiting period, and then the temperatures at Tanzhong (CV 17), Zhongwan (CV 12) and Guanyuan (CV 4) were measured using digital infrared thermal imaging. After the use of Artemisia vulgaris moxa, the patients' body temperatures were slightly lowered at Tanzhong (CV 17), Zhongwan (CV 12) and Guanyuan (CV 4), but the changes were not statistically significant. After the use of charcoal moxa, the patients' body temperatures were somewhat increased at Zhongwan (CV 12) and Guanyuan (CV 4), but the changes were not statistically significant. After Artemisia vulgaris moxa use, the body temperature difference between Zhongwan (CV 12) and Guanyuan (CV 4) was significantly increased. After charcoal moxa use, the body temperature difference between Tanzhong (CV 17) and Zhongwan (CV 12) was significantly decreased in males and in the whole group. This change was caused by the difference in the moxibustion type and by gender differences. This pilot study found that moxibustion did not raise the body temperature, but temperature differences between acupoints were affected. Further large-scale randomized controlled trials are needed for the effect of moxibustion on body temperature.

  16. Effect of sodium bicarbonate on prolonged running performance: A randomized, double-blind, cross-over study.

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    Tanja Freis

    Full Text Available The ability to sustain intense exercise seems to be partially limited by the body's capability to counteract decreases in both intra- and extracellular pH. While the influence of an enhanced buffering capacity via sodium bicarbonate (BICA on short-term, high-intensity exercise performance has been repeatedly investigated, studies on prolonged endurance performances are comparatively rare, especially for running. The aim of the following study was to assess the ergogenic effects of an oral BICA substitution upon exhaustive intensive endurance running performance.In a double-blind randomized cross-over study, 18 trained runners (VO2peak: 61.2 ± 6.4 ml•min-1•kg-1 performed two exhaustive graded exercise tests and two constant load tests (30 main at 95% individual anaerobic threshold (IAT followed by 110% IAT until exhaustion after ingestion of either sodium bicarbonate (BICA (0.3 g/kg or placebo (4 g NaCl diluted in 700 ml of water. Time to exhaustion (TTE in the constant load test was defined as the main outcome measure. Throughout each test respiratory gas exchange measurements were conducted as well as determinations of heart rate, blood gases and blood lactate concentration.TTE in the constant load test did not differ significantly between BICA and placebo conditions (BICA: 39.6 ± 5.6 min, placebo: 39.3 ± 5.6 min; p = 0.78. While pH in the placebo test dropped to a slightly acidotic value two minutes after cessation of exercise (7.34 ± 0.05 the value in the BICA trial remained within the normal range (7.41 ± 0.06 (p < 0.001. In contrast, maximum running speed (Vmax in the exhaustive graded exercise test was significantly higher with BICA (17.4 ± 1.0 km/h compared to placebo (17.1 ± 1.0 km/h (p = 0.009. The numerical difference in maximum oxygen consumption (VO2peak failed to reach statistical significance (BICA: 61.2 ± 6.4 ml•min-1•kg-1, placebo: 59.8 ± 6.4 ml•min-1•kg-1; p = 0.31. Maximum blood lactate was significantly

  17. SMALL SAMPLE SIZE IN 2X2 CROSS OVER DESIGNS: CONDITIONS OF DETERMINATION

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    B SOLEYMANI

    2001-09-01

    Full Text Available Introduction. Determination of small sample size in some clinical trials is a matter of importance. In cross-over studies which are one types of clinical trials, the matter is more significant. In this article, the conditions in which determination of small sample size in cross-over studies are possible were considered, and the effect of deviation from normality on the matter has been shown. Methods. The present study has been done on such 2x2 cross-over studies that variable of interest is quantitative one and is measurable by ratio or interval scale. The method of consideration is based on use of variable and sample mean"s distributions, central limit theorem, method of sample size determination in two groups, and cumulant or moment generating function. Results. In normal variables or transferable to normal variables, there is no restricting factors other than significant level and power of the test for determination of sample size, but in the case of non-normal variables, it should be determined such large that guarantee the normality of sample mean"s distribution. Discussion. In such cross over studies that because of existence of theoretical base, few samples can be computed, one should not do it without taking applied worth of results into consideration. While determining sample size, in addition to variance, it is necessary to consider distribution of variable, particularly through its skewness and kurtosis coefficients. the more deviation from normality, the more need of samples. Since in medical studies most of the continuous variables are closed to normal distribution, a few number of samples often seems to be adequate for convergence of sample mean to normal distribution.

  18. MIDAS (Modafinil in Debilitating Fatigue After Stroke): A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial.

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    Bivard, Andrew; Lillicrap, Thomas; Krishnamurthy, Venkatesh; Holliday, Elizabeth; Attia, John; Pagram, Heather; Nilsson, Michael; Parsons, Mark; Levi, Christopher R

    2017-05-01

    This study aimed to assess the efficacy of modafinil, a wakefulness-promoting agent in alleviating post-stroke fatigue ≥3 months after stroke. We hypothesized that 200 mg of modafinil daily for 6 weeks would result in reduced symptoms of fatigue compared with placebo. This single-center phase 2 trial used a randomized, double-blind, placebo-controlled, crossover design. The key inclusion criterion was a multidimensional fatigue inventory score of ≥60. Patients were randomized to either modafinil or placebo for 6 weeks of therapy, then after a 1 week washout period swapped treatment arms for a second 6 weeks of therapy. The primary outcome was the multidimensional fatigue inventory; secondary outcomes included the Montreal cognitive assessment, the Depression, Anxiety, and Stress Scale (DASS), and the Stroke-Specific Quality of Life (SSQoL) scale. The multidimensional fatigue inventory is a self-administered questionnaire with a range of 0 to 100. Treatment efficacy was assessed using linear regression by estimating within-person, baseline-adjusted differences in mean outcomes after therapy. This trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615000350527). A total of 232 stroke survivors were screened and 36 were randomized. Participants receiving modafinil reported a significant decrease in fatigue (multidimensional fatigue inventory, -7.38; 95% CI, -21.76 to -2.99; P modafinil therapy during the study period ( P >0.05). Stroke survivors with nonresolving fatigue reported reduced fatigue and improved quality of life after taking 200 mg daily treatment with modafinil. URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368268. Unique identifier: ACTRN12615000350527. © 2017 The Authors.

  19. Modafinil for attentional and psychomotor dysfunction in advanced cancer: a double-blind, randomised, cross-over trial

    DEFF Research Database (Denmark)

    Lundorff, L E; Jønsson, B H; Sjøgren, P

    2009-01-01

    Cognitive impairment seems to be highly prevalent in patients with advanced cancer. Modafinil, a novel vigilance and wake-promoting agent, may be an alternative treatment. We wanted to investigate this treatment on attentional and psychomotor dysfunction in cancer patients. 28 cancer patients...... to receive 200 mg Modafinil orally or placebo and on day 4 they crossed-over to the alternative treatment. Finger Tapping Test (FTT), Trail Making Test (TMT) and Edmonton Symptom Assessment System (ESAS) were evaluated before tablet intake and again 4, 5 hours after. FTT for the dominant hand as well as TMT...... were statistically significantly improved on modafinil (p-values=0.006 and 0.042, respectively). On ESAS, depression and drowsiness also improved statistically significantly (p-values=Modafinil in a single dose regimen was significantly superior to placebo regarding two...

  20. The study protocol of a blinded randomised-controlled cross-over trial of lavender oil as a treatment of behavioural symptoms in dementia

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    O'Connor Daniel W

    2010-07-01

    Full Text Available Abstract Background The agitated behaviours that accompany dementia (e.g. pacing, aggression, calling out are stressful to both nursing home residents and their carers and are difficult to treat. Increasingly more attention is being paid to alternative interventions that are associated with fewer risks than pharmacology. Lavandula angustifolia (lavender has been thought, for centuries, to have soothing properties, but the existing evidence is limited and shows mixed results. The aim of the current study is to test the effectiveness of topically applied pure lavender oil in reducing actual counts of challenging behaviours in nursing home residents. Methods/Design We will use a blinded repeated measures design with random cross-over between lavender oil and placebo oil. Persons with moderate to severe dementia and associated behavioural problems living in aged care facilities will be included in the study. Consented, willing participants will be assigned in random order to lavender or placebo blocks for one week then switched to the other condition for the following week. In each week the oils will be applied on three days with at least a two-day wash out period between conditions. Trained observers will note presence of target behaviours and predominant type of affect displayed during the 30 minutes before and the 60 minutes after application of the oil. Nursing staff will apply 1 ml of 30% high strength essential lavender oil to reduce the risk of missing a true effect through under-dosing. The placebo will comprise of jojoba oil only. The oils will be identical in appearance and texture, but can easily be identified by smell. For blinding purposes, all staff involved in applying the oil or observing the resident will apply a masking cream containing a mixture of lavender and other essential oils to their upper lip. In addition, nursing staff will wear a nose clip during the few minutes it takes to massage the oil to the resident's forearms

  1. Psychological effects of (S)-ketamine and N,N-dimethyltryptamine (DMT): a double-blind, cross-over study in healthy volunteers.

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    Gouzoulis-Mayfrank, E; Heekeren, K; Neukirch, A; Stoll, M; Stock, C; Obradovic, M; Kovar, K-A

    2005-11-01

    Pharmacological challenges with hallucinogens are used as models for psychosis in experimental research. The state induced by glutamate antagonists such as phencyclidine (PCP) is often considered as a more appropriate model of psychosis than the state induced by serotonergic hallucinogens such as lysergic acid diethylamide (LSD), psilocybin and N,N-dimethyltryptamine (DMT). However, so far, the psychological profiles of the two types of hallucinogenic drugs have never been studied directly in an experimental within-subject design. Fifteen healthy volunteers were included in a double-blind, cross-over study with two doses of the serotonin 5-HT2A agonist DMT and the glutamate N-methyl-D-aspartate (NMDA) antagonist (S)-ketamine. Data are reported for nine subjects who completed both experimental days with both doses of the two drugs. The intensity of global psychological effects was similar for DMT and (S)-ketamine. However, phenomena resembling positive symptoms of schizophrenia, particularly positive formal thought disorder and inappropriate affect, were stronger after DMT. Phenomena resembling negative symptoms of schizophrenia, attention deficits, body perception disturbances and catatonia-like motor phenomena were stronger after (S)-ketamine. The present study suggests that the NMDA antagonist model of psychosis is not overall superior to the serotonin 5-HT2A agonist model. Rather, the two classes of drugs tend to model different aspects or types of schizophrenia. The NMDA antagonist state may be an appropriate model for psychoses with prominent negative and possibly also catatonic features, while the 5-HT2A agonist state may be a better model for psychoses of the paranoid type.

  2. Effects of oral L-carnitine administration in narcolepsy patients: a randomized, double-blind, cross-over and placebo-controlled trial.

    Directory of Open Access Journals (Sweden)

    Taku Miyagawa

    Full Text Available UNLABELLED: Narcolepsy is a sleep disorder characterized by excessive daytime sleepiness, cataplexy, and rapid eye movement (REM sleep abnormalities. A genome-wide association study (GWAS identified a novel narcolepsy-related single nucleotide polymorphism (SNP, which is located adjacent to the carnitine palmitoyltransferase 1B (CPT1B gene encoding an enzyme involved in β-oxidation of long-chain fatty acids. The mRNA expression levels of CPT1B were associated with this SNP. In addition, we recently reported that acylcarnitine levels were abnormally low in narcolepsy patients. To assess the efficacy of oral L-carnitine for the treatment of narcolepsy, we performed a clinical trial administering L-carnitine (510 mg/day to patients with the disease. The study design was a randomized, double-blind, cross-over and placebo-controlled trial. Thirty narcolepsy patients were enrolled in our study. Two patients were withdrawn and 28 patients were included in the statistical analysis (15 males and 13 females, all with HLA-DQB1*06:02. L-carnitine treatment significantly improved the total time for dozing off during the daytime, calculated from the sleep logs, compared with that of placebo-treated periods. L-carnitine efficiently increased serum acylcarnitine levels, and reduced serum triglycerides concentration. Differences in the Japanese version of the Epworth Sleepiness Scale (ESS and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36 vitality and mental health subscales did not reach statistical significance between L-carnitine and placebo. This study suggests that oral L-carnitine can be effective in reducing excessive daytime sleepiness in narcolepsy patients. TRIAL REGISTRATION: University hospital Medical Information Network (UMIN UMIN000003760.

  3. [Deficient lactose digestion and intolerance in a group of patients with chronic nonspecific ulcerative colitis: a controlled, double-blind, cross-over clinical trial].

    Science.gov (United States)

    Cabrera-Acosta, G A; Milke-García, M P; Ramírez-Iglesias, M T; Uscanga, L

    2012-01-01

    Despite the fact that the frequency of hypolactasia and lactose intolerance is similar in both chronic idiopathic ulcerative colitis patients and the general population, the elimination of dairy products from the patient's diet is a habitual recommendation. Hypolactasia is common in Mexico, but its relation to chronic idiopathic ulcerative colitis has not been established. To evaluate lactose digestion and lactose intolerance in persons with chronic idiopathic ulcerative colitis. Thirty-nine patients with confirmed chronic idiopathic ulcerative colitis diagnosis were included in the study (mean: 31 years, range: 15 to 38). Twenty-two patients presented with rectosigmoid involvement and the remaining patients with pancolitis. No patient showed inflammatory activity according to the Truelove-Witts criteria and all consumed dairy products before diagnosis. A prospective, controlled, double-blind, cross-over study was designed. Patients randomly received 12.5 g of lactose or maltose in 250 cc water- each test 72 hours apart - and ydrogen was measured in exhaled air before disaccharide ingestion and then every 30 minutes for 3 hours. Digestion was considered deficient when there was an increase in hydrogen of at least 20 ppm. Symptom intensities were evaluated by Visual Analog Scales before, during, and after the hydrogen test. Differences between the groups were contrasted with the Mann-Whitney U and the Wilcoxon tests. Eighteen patients (46%) presented with deficient lactose digestion. No significant differences were found in the symptoms, extension, or progression of chronic idiopathic ulcerative colitis between patients that could digest and those that could not digest lactose. No patient had symptom exacerbation with the disaccharides used. Lactose digestion deficiency frequency is similar in subjects with chronic idiopathic ulcerative colitis and in healthy individuals in Mexico. We do not know whether higher doses could have some effect, but symptoms in patients

  4. The study protocol of a blinded randomised-controlled cross-over trial of lavender oil as a treatment of behavioural symptoms in dementia.

    Science.gov (United States)

    van der Ploeg, Eva S; Eppingstall, Barbara; O'Connor, Daniel W

    2010-07-22

    The agitated behaviours that accompany dementia (e.g. pacing, aggression, calling out) are stressful to both nursing home residents and their carers and are difficult to treat. Increasingly more attention is being paid to alternative interventions that are associated with fewer risks than pharmacology. Lavandula angustifolia (lavender) has been thought, for centuries, to have soothing properties, but the existing evidence is limited and shows mixed results. The aim of the current study is to test the effectiveness of topically applied pure lavender oil in reducing actual counts of challenging behaviours in nursing home residents. We will use a blinded repeated measures design with random cross-over between lavender oil and placebo oil. Persons with moderate to severe dementia and associated behavioural problems living in aged care facilities will be included in the study. Consented, willing participants will be assigned in random order to lavender or placebo blocks for one week then switched to the other condition for the following week. In each week the oils will be applied on three days with at least a two-day wash out period between conditions. Trained observers will note presence of target behaviours and predominant type of affect displayed during the 30 minutes before and the 60 minutes after application of the oil. Nursing staff will apply 1 ml of 30% high strength essential lavender oil to reduce the risk of missing a true effect through under-dosing. The placebo will comprise of jojoba oil only. The oils will be identical in appearance and texture, but can easily be identified by smell. For blinding purposes, all staff involved in applying the oil or observing the resident will apply a masking cream containing a mixture of lavender and other essential oils to their upper lip. In addition, nursing staff will wear a nose clip during the few minutes it takes to massage the oil to the resident's forearms. If our results show that the use of lavender oil is

  5. Mequitazine and dexchlorpheniramine in perennial rhinitis. A double-blind cross-over placebo-controlled study.

    Science.gov (United States)

    Pukander, J S; Karma, P H; Penttilä, M A; Perälä, M E; Ylitalo, P; Kataja, M J

    1990-12-01

    The therapeutic effect and adverse reactions of two antihistamines, mequitazine and dexchlorpheniramine were double-blindly compared both to placebo, to each other and to the pre-treatment status in 29 adult patients suffering from perennial rhinitis. Dexchlorpheniramine relieved the rhinitis symptoms significantly (p less than 0.01) better compared to placebo while mequitazine did not differ from placebo. 20 out of 29 patients chose dexchlorpheniramine as their favourite drug. Dexchlorpheniramine reduced all the separate symptoms studied (obstruction, rhinorrhoea, sneezing) significantly, mequitazine relieving merely rhinorrhoea. In anterior rhinoscopy mucosal congestion was reduced both by dexhlorpheniramine (p less than 0.01) and by mequitazine (p less than 0.05) but secretion or lividity showed no difference between the active drugs and placebo. The occurrence of side-effects was not significantly different between the drugs. In controlling perennial rhinitis symptoms mequitazine was markedly inferior to dexchlorpheniramine and only slightly better than placebo.

  6. Caffeine improves endurance in 75-year old citizens. A randomized, double-blind, placebo-controlled, cross-over study

    DEFF Research Database (Denmark)

    Buchard Nørager, Charlotte; Jensen, Martin Bach; Madsen, Mogens Rørbæk

    2005-01-01

    This study investigated the effect of caffeine on physical performance in healthy citizens aged ≥70 yr. The randomized, double-blind, placebo-controlled, crossover study was conducted in 15 men and 15 women recruited by their general practitioner. Participants abstained from caffeine for 48 h...... of the study, 46% of participants correctly identified when they received caffeine and placebo. Caffeine increased exercise endurance in healthy citizens aged ≥70 yr, but the participants' reasons for stopping the test may have varied between subjects, as the cycling test was done at ∼55% of maximal oxygen...... consumption. Further studies are required to investigate whether caffeine can be utilized to improve the physical performance of elderly citizens....

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

    Science.gov (United States)

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

    2015-09-01

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

  8. Sildenafil citrate (Viagra) and erectile dysfunction following external beam radiotherapy for prostate cancer: a randomized, double-blind, placebo-controlled, cross-over study

    International Nuclear Information System (INIS)

    Incrocci, Luca; Koper, Peter C.M.; Hop, Wim C.J.; Slob, A. Koos

    2001-01-01

    Purpose: To determine the efficacy of sildenafil citrate (Viagra) in patients with erectile dysfunction after three-dimensional conformal external beam radiotherapy (3D-CRT) for prostate cancer. Methods and Materials: 406 patients with complaints of erectile dysfunction and who completed radiation at least 6 months before the study were approached by mail. 3D-CRT had been delivered (mean dose 68 Gy). Sixty patients were included and entered a double-blind, placebo-controlled, cross-over study lasting 12 weeks. They received during 2 weeks 50 mg of sildenafil or placebo; at Week 2 the dose was increased to 100 mg in case of unsatisfactory erectile response. At Week 6, patients crossed over to the alternative treatment. Data were collected using the International Index of Erectile Function (IIEF) questionnaire, and side effects were recorded. Results: Mean age was 68 years. All patients completed the study. For most questions of the IIEF questionnaire there was a significant increase in mean scores from baseline with sildenafil, but not with placebo. Ninety percent of the patients needed a dose adjustment to 100 mg sildenafil. Side effects were mild or moderate. Conclusion: Sildenafil is well tolerated and effective in improving erectile function of patients with ED after 3D-CRT for prostate cancer

  9. Circadian rhythms of hemostatic factors in tetraplegia: a double-blind, randomized, placebo-controlled cross-over study of melatonin.

    Science.gov (United States)

    Kostovski, E; Dahm, A E A; Mowinckel, M C; Stranda, A; Skretting, G; Østerud, B; Sandset, P M; Iversen, P O

    2015-04-01

    This is a double-blind, randomized, placebo-controlled cross-over study of melatonin in complete tetraplegia. Tetraplegic patients have an increased risk of venous thrombosis despite prophylaxis, blunted variations in melatonin and altered circadian variation of several hemostatic markers. To examine whether melatonin could modify the regulation of hemostasis, we measured plasma melatonin and several markers of hemostasis in tetraplegic subjects with or without melatonin supplement. The study was conducted in the Section for Spinal Cord Injury, Sunnaas Hospital, Nesoddtangen, Norway. Six subjects with long-standing complete tetraplegia were included in this cross-over study with 2 mg of melatonin or placebo given 4 days before sampling. We also included six able-bodied men without any intervention. Plasma samples were then collected frequently during a 24-h awake/sleep cycle. The plasma concentrations of melatonin and the various markers were analyzed using linear mixed models. The 24-h profiles of prothrombin fragment 1+2 and von Willebrand factor, but not D-dimer, activated FVII, tissue factor pathway inhibitor and plasminogen activator inhibitor type 1, differed (Ptetraplegia. Financial support was provided from the Throne Holst Foundation.

  10. Repetitive transcranial magnetic stimulation for apathy in mild cognitive impairment: A double-blind, randomized, sham-controlled, cross-over pilot study.

    Science.gov (United States)

    Padala, Prasad R; Padala, Kalpana P; Lensing, Shelly Y; Jackson, Andrea N; Hunter, Cassandra R; Parkes, Christopher M; Dennis, Richard A; Bopp, Melinda M; Caceda, Ricardo; Mennemeier, Mark S; Roberson, Paula K; Sullivan, Dennis H

    2018-03-01

    Apathy is a common and disabling behavioral concomitant of many neurodegenerative conditions. The presence of apathy with Mild Cognitive Impairment (MCI) is linked with heightened rates of conversion to Alzheimer's disease. Improving apathy may slow the neurodegenerative process. The objective was to establish the efficacy of repetitive transcranial magnetic stimulation (rTMS) in improving apathy in older adults with MCI. An 8-week, double-blind, randomized, sham-controlled cross-over study was conducted in nine subjects (66 ± 9 years) with apathy and MCI. Subjects were randomized to rTMS or sham treatment (5 days/week) for 2 weeks following which they underwent a 4-week treatment-free period. Subjects then crossed-over to receive the other treatment for 2 weeks. The primary (apathy (AES-C)) and secondary (cognition (3MS & MMSE), executive function (TMT-A & TMT-B), and clinical global impression (CGI)) outcomes were assessed at baseline, 2, 6, and 8 weeks. After adjusting for baseline, there was a significantly greater improvement in the AES-C with rTMS compared to sham treatment at 2 weeks. There was significantly greater improvement in 3MS, MMSE, TMT-A, and CGI-I with rTMS compared to the sham treatment. This study establishes that rTMS is efficacious in improving apathy in subjects with MCI. Published by Elsevier B.V.

  11. Enriched Air Nitrox Breathing Reduces Venous Gas Bubbles after Simulated SCUBA Diving: A Double-Blind Cross-Over Randomized Trial.

    Directory of Open Access Journals (Sweden)

    Vincent Souday

    Full Text Available To test the hypothesis whether enriched air nitrox (EAN breathing during simulated diving reduces decompression stress when compared to compressed air breathing as assessed by intravascular bubble formation after decompression.Human volunteers underwent a first simulated dive breathing compressed air to include subjects prone to post-decompression venous gas bubbling. Twelve subjects prone to bubbling underwent a double-blind, randomized, cross-over trial including one simulated dive breathing compressed air, and one dive breathing EAN (36% O2 in a hyperbaric chamber, with identical diving profiles (28 msw for 55 minutes. Intravascular bubble formation was assessed after decompression using pulmonary artery pulsed Doppler.Twelve subjects showing high bubble production were included for the cross-over trial, and all completed the experimental protocol. In the randomized protocol, EAN significantly reduced the bubble score at all time points (cumulative bubble scores: 1 [0-3.5] vs. 8 [4.5-10]; P < 0.001. Three decompression incidents, all presenting as cutaneous itching, occurred in the air versus zero in the EAN group (P = 0.217. Weak correlations were observed between bubble scores and age or body mass index, respectively.EAN breathing markedly reduces venous gas bubble emboli after decompression in volunteers selected for susceptibility for intravascular bubble formation. When using similar diving profiles and avoiding oxygen toxicity limits, EAN increases safety of diving as compared to compressed air breathing.ISRCTN 31681480.

  12. Enriched Air Nitrox Breathing Reduces Venous Gas Bubbles after Simulated SCUBA Diving: A Double-Blind Cross-Over Randomized Trial.

    Science.gov (United States)

    Souday, Vincent; Koning, Nick J; Perez, Bruno; Grelon, Fabien; Mercat, Alain; Boer, Christa; Seegers, Valérie; Radermacher, Peter; Asfar, Pierre

    2016-01-01

    To test the hypothesis whether enriched air nitrox (EAN) breathing during simulated diving reduces decompression stress when compared to compressed air breathing as assessed by intravascular bubble formation after decompression. Human volunteers underwent a first simulated dive breathing compressed air to include subjects prone to post-decompression venous gas bubbling. Twelve subjects prone to bubbling underwent a double-blind, randomized, cross-over trial including one simulated dive breathing compressed air, and one dive breathing EAN (36% O2) in a hyperbaric chamber, with identical diving profiles (28 msw for 55 minutes). Intravascular bubble formation was assessed after decompression using pulmonary artery pulsed Doppler. Twelve subjects showing high bubble production were included for the cross-over trial, and all completed the experimental protocol. In the randomized protocol, EAN significantly reduced the bubble score at all time points (cumulative bubble scores: 1 [0-3.5] vs. 8 [4.5-10]; P diving profiles and avoiding oxygen toxicity limits, EAN increases safety of diving as compared to compressed air breathing. ISRCTN 31681480.

  13. Effects of smartphone use with and without blue light at night in healthy adults: A randomized, double-blind, cross-over, placebo-controlled comparison.

    Science.gov (United States)

    Heo, Jung-Yoon; Kim, Kiwon; Fava, Maurizio; Mischoulon, David; Papakostas, George I; Kim, Min-Ji; Kim, Dong Jun; Chang, Kyung-Ah Judy; Oh, Yunhye; Yu, Bum-Hee; Jeon, Hong Jin

    2017-04-01

    Smartphones deliver light to users through Light Emitting Diode (LED) displays. Blue light is the most potent wavelength for sleep and mood. This study investigated the immediate effects of smartphone blue light LED on humans at night. We investigated changes in serum melatonin levels, cortisol levels, body temperature, and psychiatric measures with a randomized, double-blind, cross-over, placebo-controlled design of two 3-day admissions. Each subject played smartphone games with either conventional LED or suppressed blue light from 7:30 to 10:00PM (150 min). Then, they were readmitted and conducted the same procedure with the other type of smartphone. Serum melatonin levels were measured in 60-min intervals before, during and after use of the smartphones. Serum cortisol levels and body temperature were monitored every 120 min. The Profile of Mood States (POMS), Epworth Sleepiness Scale (ESS), Fatigue Severity Scale (FSS), and auditory and visual Continuous Performance Tests (CPTs) were administered. Among the 22 participants who were each admitted twice, use of blue light smartphones was associated with significantly decreased sleepiness (Cohen's d = 0.49, Z = 43.50, p = 0.04) and confusion-bewilderment (Cohen's d = 0.53, Z = 39.00, p = 0.02), and increased commission error (Cohen's d = -0.59, t = -2.64, p = 0.02). Also, users of blue light smartphones experienced a longer time to reach dim light melatonin onset 50% (2.94 vs. 2.70 h) and had increases in body temperature, serum melatonin levels, and cortisol levels, although these changes were not statistically significant. Use of blue light LED smartphones at night may negatively influence sleep and commission errors, while it may not be enough to lead to significant changes in serum melatonin and cortisol levels. Copyright © 2016 Elsevier Ltd. All rights reserved.

  14. Efficacy of topical Rose (Rosa damascena Mill.) oil for migraine headache: A randomized double-blinded placebo-controlled cross-over trial.

    Science.gov (United States)

    Niazi, Maria; Hashempur, Mohammad Hashem; Taghizadeh, Mohsen; Heydari, Mojtaba; Shariat, Abdolhamid

    2017-10-01

    To evaluate the effect of topical formulation of Rosa damascena Mill. (R. damascena) oil on migraine headache, applying syndrome diffrentiation model. Forty patients with migraine headache were randomly assigned to 2 groups of this double-blind, placebo-controlled cross-over trial. The patients were treated for the first 2 consecutive migraine headache attacks by topical R. damascena oil or placebo. Then, after one week of washout period, cross-over was done. Pain intensity of the patients' migraine headache was recorded at the beginnig and ten-sequence time schadule of attacks up to 24h. In addition, photophobia, phonophobia, and nausea and/or vomitting (N/V) of the patients were recorded as secondary outcomes. Finally, gathered data were analysed in a syndrome differentiation manner to assess the effect of R. damascena oil on Hot- and Cold-type migraine headache. Mean pain intensity of the patients' migraine headache in the different time-points after R. damascena oil or placebo use, was not significantly different. Additionally, regarding mean scores of N/V, photophobia, and phonophobia severity of the patients, no significant differences between the two groups were observed. Finally, applying syndrome differentiation model, the mean score of migraine headache pain intensity turned out to be significantly lower in patients with "hot" type migraine syndrome at in 30, 45, 60, 90, and 120min after R. damascena oil application compared to "cold" types (P values: 0.001, 0.001, <0.001, <0.001, and 0.02; respectively). It seems that syndrome differentiation can help in selection of patients who may benefit from the topical R. damascena oil in short-term relief of pain intensity in migraine headache. Further studies of longer follow-up and larger study population, however, are necessitated for more scientifically rigorous judgment on efficacy of R. damascena oil for patients with migraine headache. Copyright © 2017 Elsevier Ltd. All rights reserved.

  15. A double-blind placebo-controlled cross-over study of the vascular effects of midodrine in neuropathic compared with hyperadrenergic postural tachycardia syndrome.

    Science.gov (United States)

    Ross, Amanda J; Ocon, Anthony J; Medow, Marvin S; Stewart, Julian M

    2014-02-01

    POTS (postural tachycardia syndrome) is a chronic form of OI (orthostatic intolerance). Neuropathic POTS is characterized by decreased adrenergic vasoconstriction, whereas hyperadrenergic POTS exhibits increased adrenergic vasoconstriction. We hypothesized that midodrine, an α1-adrenergic receptor agonist, would increase CVR (calf vascular resistance), decrease C(v) (calf venous capacitance) and decrease orthostatic tachycardia in neuropathic POTS, but not alter haemodynamics in hyperadrenergic POTS. A total of 20 POTS patients (12 neuropathic and eight hyperadrenergic), ages 12-20 years, participated in this randomized placebo-controlled double-blind cross-over study. Of these subjects, 15 were female. POTS subjects received 2 weeks of treatment with midodrine or placebo, with increased dosing from 2.5 to 10 mg three times daily. Following a 7-day drug-washout period, subjects received the cross-over treatment. HR (heart rate), MAP (mean arterial pressure), Q(calf) (calf blood flow) and CVR were measured supine and during 35° HUT (head-up tilt). C(v) was measured supine. In neuropathic POTS, midodrine decreased supine HR, Q(calf) and C(v), while increasing MAP and CVR compared with placebo. During HUT, in neuropathic POTS, midodrine decreased HR, Q(calf) and C(v), while increasing MAP and CVR. In hyperadrenergic POTS, placebo and midodrine both decreased upright HR and increased supine CVR. Placebo also increased supine C(v), compared with midodrine in hyperadrenergic POTS. Therefore midodrine improved postural tachycardia in neuropathic POTS by increasing CVR and decreasing Q(calf) and C(v), whereas these effects were not seen in hyperadrenergic POTS patients who experienced a placebo effect. This suggests that midodrine is probably an effective treatment for neuropathic POTS, but not for hyperadrenergic POTS.

  16. Mono- and diglycerides improve lutein absorption in healthy adults: a randomised, double-blind, cross-over, single-dose study.

    Science.gov (United States)

    Marriage, Barbara J; Williams, Jennifer A; Choe, Yong S; Maki, Kevin C; Vurma, Mustafa; DeMichele, Stephen J

    2017-11-01

    With the association between increased carotenoid intake and lower risk of chronic diseases, the absorption of lutein from the diet becomes an important factor in its delivery and physiological action. The primary objective of this study was to gain an understanding of how a new formulation technology (mixture of mono- and diglycerides (MDG)), affected lutein absorption. Subjects (n 24) were randomised in a cross-over, double-blind study to receive a single dose of 6 mg lutein (FloraGLO 20 %) provided as capsules containing either high-oleic safflower (SAF) oil or a MDG oil. Subjects receiving a single dose of lutein in MDG showed a significantly greater change from baseline (0 h) to 4, 6, 8, 12, 24, 48 and 336 h (Plutein at 48 and 336 h (Plutein in SAF. Analysis of the 48 h absorption kinetics of lutein showed that the time to peak level of lutein (12 h) was the same for SAF and MDG groups, but the change in plasma lutein at 12 and 48 h were 129 and 320 % higher, respectively, for MDG compared with SAF. This difference continued as the adjusted AUC 0-48 and 0-336 h for the MDG group was 232 and 900 % higher, respectively, v. SAF. The study data show that by changing the lipid that is combined with a lutein supplement results in significant increases in lutein absorption in healthy adults.

  17. Clinical relevance of IgG antibodies against food antigens in Crohn's disease: a double-blind cross-over diet intervention study.

    Science.gov (United States)

    Bentz, S; Hausmann, M; Piberger, H; Kellermeier, S; Paul, S; Held, L; Falk, W; Obermeier, F; Fried, M; Schölmerich, J; Rogler, G

    2010-01-01

    Environmental factors are thought to play an important role in the development of Crohn's disease (CD). Immune responses against auto-antigens or food antigens may be a reason for the perpetuation of inflammation. In a pilot study, 79 CD patients and 20 healthy controls were examined for food immunoglobulin G (IgG). Thereafter, the clinical relevance of these food IgG antibodies was assessed in a double-blind cross-over study with 40 patients. Based on the IgG antibodies, a nutritional intervention was planned. The interferon (IFN)gamma secretion of T cells was measured. Eosinophil-derived neurotoxin was quantified in stool. The pilot study resulted in a significant difference of IgG antibodies in serum between CD patients and healthy controls. In 84 and 83% of the patients, respectively, IgG antibodies against processed cheese and yeast were detected. The daily stool frequency significantly decreased by 11% during a specific diet compared with a sham diet. Abdominal pain reduced and general well-being improved. IFNgamma secretion of T cells increased. No difference for eosinophil-derived neurotoxin in stool was detected. A nutritional intervention based on circulating IgG antibodies against food antigens showed effects with respect to stool frequency. The mechanisms by which IgG antibodies might contribute to disease activity remain to be elucidated.

  18. Effectiveness of low-dose doxycycline (LDD on clinical symptoms of Sjögren's Syndrome: a randomized, double-blind, placebo controlled cross-over study

    Directory of Open Access Journals (Sweden)

    Vuotila Tuija

    2007-12-01

    Full Text Available Abstract Background Matrix metalloproteinases (MMPs are proteolytic enzymes that may contribute to tissue destruction in Sjögren's syndrome (SS. Low-dose doxycycline (LDD inhibits MMPs. We evaluated the efficacy of LDD for the subjective symptoms in primary SS patients. This was a randomized, double blind, placebo controlled cross-over study. 22 patients were randomly assigned to receive either 20 mg LDD or matching placebo twice a day for 10 weeks. The first medication period was followed by 10-week washout period, after which the patient received either LDD or placebo, depending on the first drug received, followed by the second washout period. Stimulated saliva flow rates and pH were measured before and after one and ten weeks of each medication and after washout periods. VAS scale was used to assess the effect of LDD and placebo on following six subjective symptoms: xerostomia; xerophtalmia; difficulty of swallowing; myalgia; arthralgia; and fatigue. The effect was evaluated for each medication and washout period separately. Results Overall, the effects of medications on subjective symptoms were minor. Wilcoxon test demonstrated increased fatigue with LDD during medication (p Conclusion LDD may not be useful in reducing the primary SS symptoms.

  19. Aniracetam tested in chronic psychosyndrome after long-term exposure to organic solvents. A randomized, double-blind, placebo-controlled cross-over study with neuropsychological tests.

    Science.gov (United States)

    Somnier, F E; Ostergaard, M S; Boysen, G; Bruhn, P; Mikkelsen, B O

    1990-01-01

    In order to examine if the nootropic drug, aniracetam, was capable of improving cognitive performance, 44 subjects suffering from chronic psychosyndrome after long-term exposure to organic solvents were included in a randomized, double-blind, placebo-controlled, cross-over study. The treatment periods were 3 months with aniracetam 1 g daily and 3 months with placebo. Neuropsychological tests as well as a physical and neurological examination were performed at entry into the study and after each treatment period, together with an evaluation of the subjects' overall condition. Neither the doctors' nor the subjects' own assessment of the overall condition indicated that the trial medication had had any effect. No significant changes in neuropsychological symptoms were observed. A statistically significant difference in favour of antiracetam was found in only 1 of the 19 neuropsychological test measures, namely a test for constructional ability. However, in another test on visuo-spatial function, a statistically significant result was found in favour of placebo. Thus, aniracetam was found to be ineffective in the treatment of subjects suffering from chronic psychosyndrome after long-term exposure to organic solvents.

  20. Intranasal oxytocin reduces heart rate variability during a mental arithmetic task: A randomised, double-blind, placebo-controlled cross-over study.

    Science.gov (United States)

    Tracy, Lincoln M; Gibson, Stephen J; Labuschagne, Izelle; Georgiou-Karistianis, Nellie; Giummarra, Melita J

    2018-02-02

    Heart rate variability (HRV) refers to variation in the interval between successive heart beats. Low HRV is an indicator of potential autonomic nervous system dysfunction. People with chronic pain often display autonomic dysregulation, especially in the parasympathetic nervous system. The hormone oxytocin has been shown to increase HRV in non-clinical samples, but its potential impact on HRV in persons with chronic pain is unknown. This study investigated the impact of intranasal oxytocin on HRV in persons with chronic neck and shoulder pain. Participants included 24 individuals with chronic neck and shoulder pain lasting >12months and 24 age- and sex-matched pain-free controls. In a randomised double-blind, placebo-controlled, cross-over study, participants self-administered intranasal oxytocin (24IU) in one session, and placebo in another, before HRV was recorded at rest and during a mental arithmetic task. Intranasal oxytocin did not influence HRV at rest. However, compared to placebo, intranasal oxytocin elicited small decreases in low-frequency and high-frequency HRV in both groups during the mental arithmetic task. These results suggest that intranasal oxytocin may enhance the salience of the mental arithmetic task, leading to reduced engagement of the parasympathetic nervous system when completing the task. Further investigation and replication of these findings are required to improve our understanding of the effects of intranasal oxytocin on autonomic functioning both at rest and under cognitive stress. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

  1. Treatment of epistaxis in hereditary hemorrhagic telangiectasia with tranexamic acid - a double-blind placebo-controlled cross-over phase IIIB study.

    Science.gov (United States)

    Geisthoff, Urban W; Seyfert, Ulrich T; Kübler, Marcus; Bieg, Birgitt; Plinkert, Peter K; König, Jochem

    2014-09-01

    Epistaxis is the most frequent manifestation in hereditary hemorrhagic telangiectasia, in which no optimal treatment exists. It can lead to severe anemia and reduced quality of life. Positive effects of tranexamic acid, an antifibrinolytic drug, have been reported on epistaxis related to this disorder. We sought to evaluate the efficacy of treating nosebleeds in hereditary hemorrhagic telangiectasia with tranexamic acid. In a randomized, double-blind, placebo controlled, cross-over phase IIIB study, 1 gram of tranexamic acid or placebo was given orally 3 times daily for 3 months for a total of 6 months. 22 patients were included in the intention-to-treat analysis. Hemoglobin levels, the primary outcome measure, did not change significantly (p=0.33). The secondary outcome measure was epistaxis score and patients reported a statistically significant reduction in nosebleeds, equaling a clinically relevant 54% diminution (p=0.0031), as compared to the placebo period. No severe side effects were observed. Tranexamic acid reduces epistaxis in patients with hereditary hemorrhagic telangiectasia. (Clinical trial registration numbers: BfArM 141 CHC 9008-001 and ClinicalTrials.gov NCT01031992). Copyright © 2014 Elsevier Ltd. All rights reserved.

  2. Synbiotic Lactobacillus acidophilus NCFM and cellobiose does not affect human gut bacterial diversity but increases abundance of lactobacilli, bifidobacteria and branched-chain fatty acids: a randomized, double-blinded cross-over trial

    DEFF Research Database (Denmark)

    van Zanten, Gabriella Christina; Krych, Lukasz; Roytio, Henna

    2014-01-01

    in a double-blinded, randomized, and placebo-controlled cross-over study and received synbiotic [Lactobacillus acidophilus NCFM (10(9)CFU) and cellobiose (5g)] or placebo daily for 3weeks. Fecal samples were collected and lactobacilli numbers were quantified by qPCR. Furthermore, 454 tag-encoded amplicon...

  3. Effects of rose hip intake on risk markers of type 2 diabetes and cardiovascular disease: a randomized, double-blind, cross-over investigation in obese persons.

    Science.gov (United States)

    Andersson, U; Berger, K; Högberg, A; Landin-Olsson, M; Holm, C

    2012-05-01

    In studies performed in mice, rose hip powder has been shown to both prevent and reverse high-fat diet-induced obesity and glucose intolerance as well as reduce plasma levels of cholesterol. The aim of this study was to investigate whether daily intake of rose hip powder over 6 weeks exerts beneficial metabolic effects in obese individuals. A total of 31 obese individuals with normal or impaired glucose tolerance were enrolled in a randomized, double-blind, cross-over study in which metabolic effects of daily intake of a rose hip powder drink over 6 weeks was compared with a control drink. Body weight, glucose tolerance, blood pressure, blood lipids and markers of inflammation were assessed in the subjects. In comparison with the control drink, 6 weeks of daily consumption of the rose hip drink resulted in a significant reduction of systolic blood pressure (-3.4%; P=0.021), total plasma cholesterol (-4.9%; P=0.0018), low-density lipoprotein (LDL) cholesterol (-6.0%; P=0.012) and LDL/HDL ratio (-6.5%; P=0.041). The Reynolds risk assessment score for cardiovascular disease was decreased in the rose hip group compared with the control group (-17%; P=0.007). Body weight, diastolic blood pressure, glucose tolerance, and plasma levels of high-density lipoprotein (HDL) cholesterol, triglycerides, incretins and markers of inflammation did not differ between the two groups. Daily consumption of 40 g of rose hip powder for 6 weeks can significantly reduce cardiovascular risk in obese people through lowering of systolic blood pressure and plasma cholesterol levels.

  4. Immediate effects after stochastic resonance whole-body vibration on physical performance on frail elderly for skilling-up training: a blind cross-over randomised pilot study.

    Science.gov (United States)

    Rogan, Slavko; Schmidtbleicher, Dietmar; Radlinger, Lorenz

    2014-10-01

    This pilot study examined the feasibility outcome recruitment, safety and compliance of the investigation for stochastic resonance whole-body vibration (SR-WBV) training. Another aim was to evaluate the effect size of one SR-WBV intervention session on Short Physical Performance Battery (SPPB), Expanded Timed Get Up-and-Go (ETGUG), isometric maximal voluntary contraction (IMVC) and rate of force development (IRFD) and chair rising (CR). Randomised double-blinded controlled cross-over pilot study. Feasibility outcomes included recruitment, safety and compliance. For secondary outcomes, SPPB, ETGUG, IMVC, IRFD and CR were measured before and 2-min after intervention. Nonparametric Rank-Order Tests of Puri and Sen L Statistics to Ranked Data were proposed. Wilcoxon signed-ranked tests were used to analyse the differences after SR-WBV intervention and sham intervention. Treatment effects between the interventions were compared by a Mann-Whitney U test. Among 24 eligible frail elderly, 12 agreed to participate and 3 drop out. The adherence was 15 of 24 intervention sessions. For secondary outcome, effect sizes (ES) for SR-WBV intervention on SPPB, ETGUG and CR were determined. This pilot study indicate that the training protocol used in this form for frail elderly individuals is feasible but with modification due to the fact that not all defined feasibility outcomes target was met. SR-WBV with 6 Hz, noise level 4 shows benefit improvements on SPPB (ES 0.52), ETGUG (part sit-to-stand movement: ES 0.81; total time: ES 0.85) and CR (ES 0.66). Further research is desired to determine whether a new adapted training protocol is necessary for SR-WBV in the "skilling up" phase in frail elderly individuals.

  5. Lactobacillus reuteri supplements do not affect salivary IgA or cytokine levels in healthy subjects: A randomized, double-blind, placebo-controlled, cross-over trial.

    Science.gov (United States)

    Jørgensen, Mette Rose; Keller, Mette Kirstine; Kragelund, Camilla; Hamberg, Kristina; Ericson, Dan; Nielsen, Claus Henrik; Twetman, Svante

    2016-07-01

    To evaluate the effect of daily ingestion of probiotic lactobacilli on the levels of secretory IgA (sIgA) and selected cytokines in whole saliva of healthy young adults. The study group consisted of 47 healthy adults (18-32 years) who volunteered for a randomized, double-blind, placebo-controlled, cross-over trial after informed consent. During intervention, the subjects ingested two lozenges per day containing two strains of the probiotic bacterium Lactobacillus reuteri (DSM 17938 and ATCC PTA 5289) or placebo lozenges. The intervention and wash-out periods were 3 weeks. Saliva samples were collected at baseline, immediately after each intervention period and 3 weeks post-intervention. ELISA was used to measure sIgA and luminex technology was used to measure the interleukins (IL)-1β, IL-6, IL-8 and IL-10. For statistical analyses a mixed ANOVA model was employed to calculate changes in the salivary outcome variables. Forty-one subjects completed the study and reported a good compliance. No significant differences in the concentrations of salivary sIgA or cytokines were recorded between the L. reuteri and placebo interventions or between baseline and 3 weeks post-intervention levels. No side- or adverse effects were reported. Supplementation with two strains of the probiotic L. reuteri did not affect sIgA or cytokine levels in whole saliva in healthy young adults. The results thereby indicate that daily oral supplementation with L. reuteri do not seem to modulate the salivary oral immune response in healthy young subjects (ClinicalTrials.gov NCT02017886).

  6. Effects of synbiotic food consumption on metabolic status of diabetic patients: a double-blind randomized cross-over controlled clinical trial.

    Science.gov (United States)

    Asemi, Zatollah; Khorrami-Rad, Ashraf; Alizadeh, Sabihe-Alsadat; Shakeri, Hossein; Esmaillzadeh, Ahmad

    2014-04-01

    We are aware of no study indicating the effects of synbiotic food consumption on metabolic profiles, inflammation and oxidative stress among diabetic patients. The aim of the current study was to investigate the effects of synbiotic food consumption on metabolic profiles, hs-CRP and biomarkers of oxidative stress in diabetic patients. This randomized double-blinded cross-over controlled clinical trial was performed among 62 diabetic patients aged 35-70 y. After a 2-wk run-in period, subjects were randomly assigned to consume either a synbiotic (n = 62) or control food (n = 62) for 6 weeks. A 3-week washout period was applied following which subjects were crossed over to the alternate treatment arm for an additional 6 weeks. The synbiotic food consisted of a probiotic viable and heat-resistant Lactobacillus sporogenes (1 × 10(7) CFU), 0.04 g inulin (HPX) as prebiotic with 0.38 g isomalt, 0.36 g sorbitol and 0.05 g stevia as sweetener per 1 g. Control food (the same substance without probiotic bacteria and prebiotic inulin) was packed in identical 9-gram packages. Patients were asked to consume the synbiotic and control foods three times a day. Fasting blood samples were taken at baseline and after a 6-wk intervention to measure metabolic profiles, hs-CRP and biomarkers of oxidative stress. Consumption of a synbiotic food, compared to the control, resulted in a significant decrease in serum insulin levels (changes from baseline: -1.75 ± 0.60 vs. +0.95 ± 1.09 μIU/mL, P = 0.03). Although we failed to find a significant effect of synbiotic food consumption on total- and LDL-cholesterol levels and HOMA-IR, the effects on FPG (22.3 vs. 4.2 mg/dL, P = 0.09), serum triglycerides (45.9 vs. 20.6 mg/dL, P = 0.08) and HDL-cholesterol levels (3.1 vs. -2 mg/dL, P = 0.06) tended to be significant. A significant reduction in serum hs-CRP levels (-1057.86 ± 283.74 vs. 95.40 ± 385.38 ng/mL, P = 0.01) was found following the consumption of synbiotic food compared with the

  7. Gastric electrical stimulation treatment of type 2 diabetes: effects of implantation versus meal-mediated stimulation. A randomized blinded cross-over trial.

    Science.gov (United States)

    Lebovitz, Harold E; Ludvik, Bernhard; Kozakowski, Jaroslaw; Tarnowski, Wieslaw; Zelewski, Mateusz; Yaniv, Irit; Schwartz, Tse'ela

    2015-07-14

    Gastric electrical stimulation with the implanted DIAMOND device has been shown to improve glycemic control and decrease weight and systolic blood pressure in patients with type 2 diabetes inadequately controlled with oral antidiabetic agents. The objective of this study was to determine if device implantation alone (placebo effect) contributes to the long-term metabolic benefits of DIAMOND(®) meal-mediated gastric electrical stimulation in patients with type 2 diabetes. The study was a 48 week randomized, blinded, cross-over trial in university centers comparing glycemic improvement of DIAMOND(®) implanted patients with type 2 diabetic with no activation of the electrical stimulation (placebo) versus meal-mediated activation of the electrical signal. The endpoint was improvement in glycemic control (HbA1c) from baseline to 24 and 48 weeks. In period 1 (0-24 weeks), equal improvement in HbA1c occurred independent of whether the meal-mediated electrical stimulation was turned on or left off (HbA1c -0.80% and -0.85% [-8.8 and -9.0 mmol/mol]). The device placebo improvement proved to be transient as it was lost in period 2 (25-48 weeks). With electrical stimulation turned off, HbA1c returned toward baseline values (8.06 compared to 8.32%; 64.2 to 67.4 mmol/mol, P = 0.465). In contrast, turning the electrical stimulation on in period 2 sustained the decrease in HbA1c from baseline (-0.93%, -10.1mmol/mol, P = 0.001) observed in period 1. The results indicate that implantation of the DIAMOND device causes a transient improvement in HbA1c which is not sustained beyond 24 weeks. Meal-mediated electrical stimulation accounts for the significant improvement in HbA1c beyond 24 weeks. © 2015 The Authors. Physiological Reports published by Wiley Periodicals, Inc. on behalf of the American Physiological Society and The Physiological Society.

  8. The impact of intranasal oxytocin on attention to social emotional stimuli in patients with anorexia nervosa: a double blind within-subject cross-over experiment.

    Directory of Open Access Journals (Sweden)

    Youl-Ri Kim

    Full Text Available BACKGROUND AND AIM: Social factors may be of importance causally and act as maintenance factors in patients with anorexia nervosa. Oxytocin is a neuromodulatory hormone involved in social emotional processing associated with attentional processes. This study aimed to examine the impact of oxytocin on attentional processes to social faces representing anger, disgust, and happiness in patients with anorexia nervosa. METHOD: A double-blind, placebo-controlled within-subject crossover design was used. Intranasal oxytocin or placebo followed by a visual probe detection task with faces depicting anger, disgust, and happiness was administered to 64 female subjects: 31 patients with anorexia nervosa and 33 control students. RESULTS: Attentional bias to the disgust stimuli was observed in both groups under the placebo condition. The attentional bias to disgust was reduced under the oxytocin condition (a moderate effect in the patient group. Avoidance of angry faces was observed in the patient group under the placebo condition and vigilance was observed in the healthy comparison group; both of these information processing responses were moderated by oxytocin producing an increase in vigilance in the patients. Happy/smiling faces did not elicit an attentional response in controls or the patients under either the placebo or oxytocin conditions. CONCLUSION: Oxytocin attenuated attentional vigilance to disgust in patients with anorexia nervosa and healthy controls. On the other hand, oxytocin changed the response to angry faces from avoidance to vigilance in patients but reduced vigilance to anger in healthy controls. We conclude that patients with anorexia nervosa appear to use different strategies/circuits to emotionally process anger from their healthy counterparts.

  9. Effect of the glucagon-like peptide-1 analogue liraglutide on coronary microvascular function in patients with type 2 diabetes – a randomized, single-blinded, cross-over pilot study

    DEFF Research Database (Denmark)

    Faber, Rebekka; Zander, Mette; Pena, Adam

    2015-01-01

    with either the GLP-1 analogue liraglutide or received no treatment for 10 weeks, in a randomized, single-blinded, cross-over setup with a 2 weeks wash-out period. The effect of liraglutide on coronary microcirculation was evaluated using non-invasive trans-thoracic Doppler-flow echocardiography during...... dipyridamole induced stress. Peripheral microvascular endothelial function was assessed by Endo-PAT2000®. Interventions were compared by two-sample t-test after ensuring no carry over effect. RESULTS: A total of 24 patients were included. Twenty patients completed the study (15 male; mean age 57 ± 9; mean BMI...

  10. Evaluation of the antihistamine effects of olopatadine and levocetirizine during a 24-h period: a double-blind, randomized, cross-over, placebo-controlled comparison in skin responses induced by histamine iontophoresis.

    Science.gov (United States)

    Takeo, Tomohiro; Kasugai, Chikatoshi; Tanaka, Rui; Ando, Takashi; Ogawa, Akina; Akita, Yoichi; Watanabe, Daisuke

    2013-12-01

    The antihistamine effects of olopatadine and levocetirizine, in standard-dose application described in their information (5 mg twice a day for olopatadine; 5 mg once daily for levocetirizine), were examined from 11.5 to 24 h after application. The test was designed in a double-blind, randomized, cross-over, placebo-controlled study of 12 healthy volunteers on histamine-induced flare and wheal response using an iontophoresis technique. The suppressive effect of olopatadine on the wheals induced by a 0.1-mA histamine iontophoresis lasted for 24 h after dosing. Both drugs inhibited flare induced by histamine iontophoresis almost completely until 24 h after the first administration. Suppression of the 0.2-mA-induced wheal response by levocetirizine, taken once daily, decreased with time, although 0.1-mA-induced flare was almost completely suppressed by the drug. Olopatadine completely suppressed even the wheal response induced by a 0.2-mA histamine iontophoresis. Compared with the placebo, the two drugs significantly suppressed the subjective itching assessed by visual analog scale at all intervals. There were no significant differences in subjective drowsiness and objective cognitive function between drug- and placebo-treated subjects. These results demonstrate that olopatadine seems to be more potent than levocetirizine when administrated in a standard dose. In conclusion, mild to moderate urticaria could be controlled by standard application as described in their information. On the other hand, severe urticaria could be managed by a standard application of olopatadine, but levocetirizine may need an additional dose to control severe urticaria. © 2013 Japanese Dermatological Association.

  11. Effects of carbohydrates-BCAAs-caffeine ingestion on performance and neuromuscular function during a 2-h treadmill run: a randomized, double-blind, cross-over placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Peltier Sébastien L

    2011-12-01

    Full Text Available Abstract Background Carbohydrates (CHOs, branched-chain amino acids (BCAAs and caffeine are known to improve running performance. However, no information is available on the effects of a combination of these ingredients on performance and neuromuscular function during running. Methods The present study was designed as a randomized double-blind cross-over placebo-controlled trial. Thirteen trained adult males completed two protocols, each including two conditions: placebo (PLA and Sports Drink (SPD: CHOs 68.6 g.L-1, BCAAs 4 g.L-1, caffeine 75 mg.L-1. Protocol 1 consisted of an all-out 2 h treadmill run. Total distance run and glycemia were measured. In protocol 2, subjects exercised for 2 h at 95% of their lowest average speeds recorded during protocol 1 (whatever the condition. Glycemia, blood lactate concentration and neuromuscular function were determined immediately before and after exercise. Oxygen consumption (V˙O2, heart rate (HR and rate of perceived exertion (RPE were recorded during the exercise. Total fluids ingested were 2 L whatever the protocols and conditions. Results Compared to PLA, ingestion of SPD increased running performance (p = 0.01, maintained glycemia and attenuated central fatigue (p = 0.04, an index of peripheral fatigue (p = 0.04 and RPE (p = 0.006. Maximal voluntary contraction, V˙O2, and HR did not differ between the two conditions. Conclusions This study showed that ingestion of a combination of CHOs, BCAAs and caffeine increased performance by about 2% during a 2-h treadmill run. The results of neuromuscular function were contrasted: no clear cut effects of SPD were observed. Trial registration ClinicalTrials.gov, http://www.clinicaltrials.gov, NCT00799630

  12. Glutamate is down-regulated and tinnitus loudness-levels decreased following rTMS over auditory cortex of the left hemisphere: A prospective randomized single-blinded sham-controlled cross-over study.

    Science.gov (United States)

    Cacace, Anthony T; Hu, Jiani; Romero, Stephen; Xuan, Yang; Burkard, Robert F; Tyler, Richard S

    2017-11-14

    Using a prospective randomized single-blinded sham-controlled cross-over design, we studied the efficacy of low frequency (1-Hz) repetitive transcranial magnetic stimulation (rTMS) over auditory cortex of the left temporal lobe as an experimental treatment modality for noise-induced tinnitus. Pre/post outcome measures for sham vs. active rTMS conditions included differential changes in tinnitus loudness, self-perceived changes in the Tinnitus Handicap Questionnaire (THQ), and neurochemical changes of brain metabolite concentrations using single voxel proton magnetic resonance spectroscopy ( 1 H-MRS) obtained from left and right auditory cortical areas. While no subject in our sample had complete abatement of their tinnitus percept, active but not sham rTMS significantly reduced the loudness level of the tinnitus perception on the order of 4.5 dB; improved subscales in several content areas on the THQ, and down regulated (reduced) glutamate concentrations specific to the auditory cortex of the left temporal lobe that was stimulated. In addition, significant pair-wise correlations were observed among questionnaire variables, metabolite variables, questionnaire-metabolite variables, and metabolite-loudness variables. As part of this correlation analysis, we demonstrate for the first time that active rTMS produced a down regulation in the excitatory neurotransmitter glutamate that was highly correlated (r = 0.77, p < 0.05) with a reduction in tinnitus loudness levels measured psychoacoustically with a magnitude estimation procedure. Overall, this study provides unique information on neurochemical, psychoacoustic, and questionnaire-related profiles which emphasizes the emerging fields of perceptual and cognitive MRS and provides a perspective on a new frontier in auditory and tinnitus-related research. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. Effect of a fermented dietary supplement containing chromium and zinc on metabolic control in patients with type 2 diabetes: a randomized, placebo-controlled, double-blind cross-over study

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    Yu-Mi Lee

    2016-06-01

    Full Text Available Background: For the increasing development of type 2 diabetes dietary habits play an important role. In this regard, dietary supplements are of growing interest to influence the progression of this disease. Objective: The aim of this study was to investigate the effect of a cascade-fermented dietary supplement based on fruits, nuts, and vegetables fortified with chromium and zinc on metabolic control in patients with type 2 diabetes mellitus. Methods: This was a randomized, placebo-controlled, double-blind, intervention study under free-living conditions using a cross-over design. Thirty-six patients with type 2 diabetes mellitus were enrolled and randomized either to receive a cascade-fermented dietary supplement enriched with chromium (100 µg/d and zinc (15 mg/d or a placebo similar in taste but without supplements, over a period of 12 weeks. After a wash-out period of 12 weeks, the patients received the other test product. The main outcome variable was the levels of glycated hemoglobin (HbA1c. Other outcome variables were fasting blood glucose, fructosamine, and lipid parameters. Results: Thirty-one patients completed the study. HbA1c showed no relevant changes during both treatment periods, nor was there a relevant difference between the two treatments (HbA1c: p=0.48. The same results were found for fructosamine and fasting glucose (fructosamine: p=0.9; fasting glucose: p=0.31. In addition, there was no effect on lipid metabolism. Conclusion: This intervention study does not provide evidence that a cascade-fermented plant-based dietary supplement enriched with a combination of chromium and zinc improves glucose metabolism in patients with type 2 diabetes mellitus under free-living conditions.

  14. Oral and Vaginal Tenofovir for Genital Herpes Simplex Virus Type 2 Shedding in Immunocompetent Women: A Double-Blind, Randomized, Cross-over Trial.

    Science.gov (United States)

    Bender Ignacio, Rachel A; Perti, Tara; Magaret, Amalia S; Rajagopal, Sharanya; Stevens, Claire E; Huang, Meei-Li; Selke, Stacy; Johnston, Christine; Marrazzo, Jeanne; Wald, Anna

    2015-12-15

    Tenofovir is a potent anti-human immunodeficiency virus (HIV) agent that decreased risk of herpes simplex virus type 2 (HSV-2) acquisition in HIV pre-exposure prophylaxis trials. Whether tenofovir has utility in established HSV-2 disease is unclear. We randomized immunocompetent women with symptomatic HSV-2 infection to oral tenofovir disoproxil fumarate (TDF)/placebo vaginal gel, oral placebo/tenofovir (TFV) vaginal gel, or double placebo (ratio 2:2:1) in a one-way cross-over trial. Women collected genital swabs twice daily for HSV PCR during 4-week lead-in and 5-week treatment phases. The primary intent-to-treat end point was within-person comparison of genital HSV shedding and lesion rates. 64 women completed the lead-in phase and were randomized. Neither TDF nor TFV gel decreased overall shedding or lesion rate in the primary analysis; TFV gel decreased quantity of HSV DNA by -0.50 (-0.86-0.13) log10 copies/mL. In the per-protocol analysis, TDF reduced shedding (relative risk [RR] = 0.74, P = .006) and lesion rates (RR = 0.75, P = .032); quantity of virus shed decreased by 0.41 log10 copies/mL. Oral TDF modestly decreased HSV shedding and lesion rate, and quantity of virus shed when used consistently. Vaginal TFV gel decreased quantity of virus shed by 60%. In contrast to effects on HSV-2 acquisition, tenofovir is unlikely to provide clinically meaningful reductions in the frequency of HSV shedding or genital lesions. NCT01448616. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  15. Effects of a multivitamin/multimineral supplement on young males with physical overtraining: a placebo-controlled, randomized, double-blinded cross-over trial.

    Science.gov (United States)

    Li, Xin; Huang, Wen Xu; Lu, Ju Ming; Yang, Guang; Ma, Fang Ling; Lan, Ya Ting; Meng, Jun Hua; Dou, Jing Tao

    2013-07-01

    To investigate the effects of vitamin-mineral supplement on young males with physical overtraining. Two hundred and forty male Chinese field artillery personnel who undertook large scale and endurance military training and were on ordinary Chinese diet were randomized to receive a multivitamin/multimineral supplement or a placebo for 1 week. After a 1-week wash-out period, a cross-over with 1 week course of a placebo or multivitamin/multimineral supplement was conducted. Blood and urine samples were analyzed for adrenal, gonadal and thyroid hormones. In addition, cellular immune parameters (CD3+, CD3+CD4+, CD3+CD8+, CD4/CD8, CD3-CD56+, CD3-CD19+) were examined and psychological tests were performed before and after the training program and nutrition intervention. After a large scale and endurance military training, the participants showed significantly increased thyroid function, decreased adrenal cortex, testosterone and immunological function, and significantly increased somatization, anger and tension. Compared to placebo, multivitamin/ multimineral intervention showed significant effects on functional recovery of the pituitary - adrenal axis, pituitary-gonadal axis, pituitary- thyroid axis and immune system as well as psychological parameters. High-intensity military operations have significant impacts on the psychology, physical ability and neuroendocrine-immune system in young males. Appropriate supplementation of multivitamin/multimineral can facilitate the recovery of the psychology, physical ability and neuroendocrine-immune system in young males who take ordinary Chinese diet. Copyright © 2013 The Editorial Board of Biomedical and Environmental Sciences. Published by China CDC. All rights reserved.

  16. Persistent threats to validity in single-group interrupted time series analysis with a cross over design.

    Science.gov (United States)

    Linden, Ariel

    2017-04-01

    The basic single-group interrupted time series analysis (ITSA) design has been shown to be susceptible to the most common threat to validity-history-the possibility that some other event caused the observed effect in the time series. A single-group ITSA with a crossover design (in which the intervention is introduced and withdrawn 1 or more times) should be more robust. In this paper, we describe and empirically assess the susceptibility of this design to bias from history. Time series data from 2 natural experiments (the effect of multiple repeals and reinstatements of Louisiana's motorcycle helmet law on motorcycle fatalities and the association between the implementation and withdrawal of Gorbachev's antialcohol campaign with Russia's mortality crisis) are used to illustrate that history remains a threat to ITSA validity, even in a crossover design. Both empirical examples reveal that the single-group ITSA with a crossover design may be biased because of history. In the case of motorcycle fatalities, helmet laws appeared effective in reducing mortality (while repealing the law increased mortality), but when a control group was added, it was shown that this trend was similar in both groups. In the case of Gorbachev's antialcohol campaign, only when contrasting the results against those of a control group was the withdrawal of the campaign found to be the more likely culprit in explaining the Russian mortality crisis than the collapse of the Soviet Union. Even with a robust crossover design, single-group ITSA models remain susceptible to bias from history. Therefore, a comparable control group design should be included, whenever possible. © 2016 John Wiley & Sons, Ltd.

  17. Antiplaque and antigingivitis efficacy of triphala and chlorhexidine mouthrinse among schoolchildren - a cross-over, double-blind, randomised controlled trial.

    Science.gov (United States)

    Chainani, Swati H; Siddana, Sunitha; Reddy, Cvk; Manjunathappa, Thippeswamy H; Manjunath, Maurya; Rudraswamy, Sushma

    2014-01-01

    To evaluate and compare the effect of triphala extract mouthrinse and chlorhexidine on dental plaque and gingivitis. In this double blind, crossover study, 120 qualifying boarding-school students aged 13-16 years were randomised into three groups: 10% triphala, 0.2% chlorhexidine and negative control. The study was conducted in 3 phases of 1-month duration each and a washout period of 15 days. During the experimental period, subjects rinsed with the allocated mouthrinse once daily for 30 s under supervision. The plaque and gingival status was assessed using the Turesky modification of the Quigley and Hein plaque index (QHI) and the gingival index (Löe and Silness) at baseline and at the end of each phase. The results were tested for significance at P chlorhexidine yielded a significant reduction in plaque and gingival index scores as compared to negative control (P chlorhexidine mouthwashes. The antiplaque and antigingivitis activity of triphala closely parallels that of chlorhexidine.

  18. Comparing the effects of two inhaled glucocorticoids on allergen-induced bronchoconstriction and markers of systemic effects, a randomised cross-over double-blind study

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    Lötvall Jan

    2011-10-01

    Full Text Available Abstract Background Inhaled glucocorticoids are efficient in protecting against asthma exacerbations, but methods to compare their efficacy vs systemic effects have only been attempted in larger multi-centre studies. The aim of the current study was therefore to directly compare the effects of two separate inhaled glucocorticoids, mometasone and budesonide, to compare the effects on the early and late asthmatic responses to inhaled allergen in patients with mild allergic asthma, and sputum eosinophils, and to relate the clinical positive effects to any systemic effects observed. Methods Twelve patients with documented early and late asthmatic responses (EAR and LAR to inhaled allergen at a screening visit were randomized in a double-blind fashion to treatment with mometasone (200 μg × 2 or 400 μg × 2, budesonide (400 μg × 2 or placebo in a double-blind crossover fashion for a period of seven days. Challenge with the total allergen dose causing both an EAR and LAR was given on the last day of treatment taken in the morning. Lung function was assessed using FEV1, and systemic glucocorticoid activity was quantified using 24 h urinary cortisol. Results Mometasone and budesonide attenuate both EAR and LAR to allergen to a similar degree. No significant dose-related effects on the lung function parameters were observed. Both treatments reduced the relative amount of sputum eosinophils (% after allergen. At the dose of 800 μg daily, mometasone reduced 24 h urinary cortisol by approximately 35%. Both drugs were well tolerated. Conclusions Mometasone and budesonide are equieffective in reducing early and late asthmatic responses induced by inhaled allergen challenge. Mometasone 800 μg given for seven days partially affects the HPA axis.

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

    Directory of Open Access Journals (Sweden)

    Rueda-Clausen Christian F

    2006-09-01

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

  20. Phenol-enriched olive oils improve HDL antioxidant content in hypercholesterolemic subjects. A randomized, double-blind, cross-over, controlled trial.

    Science.gov (United States)

    Farràs, Marta; Fernández-Castillejo, Sara; Rubió, Laura; Arranz, Sara; Catalán, Úrsula; Subirana, Isaac; Romero, Mari-Paz; Castañer, Olga; Pedret, Anna; Blanchart, Gemma; Muñoz-Aguayo, Daniel; Schröder, Helmut; Covas, Maria-Isabel; de la Torre, Rafael; Motilva, Maria-José; Solà, Rosa; Fitó, Montserrat

    2018-01-01

    At present, high-density lipoprotein (HDL) function is thought to be more relevant than HDL cholesterol quantity. Consumption of olive oil phenolic compounds (PCs) has beneficial effects on HDL-related markers. Enriched food with complementary antioxidants could be a suitable option to obtain additional protective effects. Our aim was to ascertain whether virgin olive oils (VOOs) enriched with (a) their own PC (FVOO) and (b) their own PC plus complementary ones from thyme (FVOOT) could improve HDL status and function. Thirty-three hypercholesterolemic individuals ingested (25 ml/day, 3 weeks) (a) VOO (80 ppm), (b) FVOO (500 ppm) and (c) FVOOT (500 ppm) in a randomized, double-blind, controlled, crossover trial. A rise in HDL antioxidant compounds was observed after both functional olive oil interventions. Nevertheless, α-tocopherol, the main HDL antioxidant, was only augmented after FVOOT versus its baseline. In conclusion, long-term consumption of phenol-enriched olive oils induced a better HDL antioxidant content, the complementary phenol-enriched olive oil being the one which increased the main HDL antioxidant, α-tocopherol. Complementary phenol-enriched olive oil could be a useful dietary tool for improving HDL richness in antioxidants. Copyright © 2017. Published by Elsevier Inc.

  1. Monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, and curcumin: a randomized, double-blind placebo-controlled cross-over 4g study and an open-label 8g extension study.

    Science.gov (United States)

    Golombick, Terry; Diamond, Terrence H; Manoharan, Arumugam; Ramakrishna, Rajeev

    2012-05-01

    Monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM) represent useful models for studying multiple myeloma precursor disease, and for developing early intervention strategies. Administering a 4g dose of curcumin, we performed a randomised, double-blind placebo-controlled cross-over study, followed by an open-label extension study using an 8g dose to assess the effect of curcumin on FLC response and bone turnover in patients with MGUS and SMM. 36 patients (19 MGUS and 17 SMM) were randomised into two groups: one received 4g curcumin and the other 4g placebo, crossing over at 3 months. At completion of the 4g arm, all patients were given the option of entering an open-label, 8g dose extension study. Blood and urine samples were collected at specified intervals for specific marker analyses. Group values are expressed as mean ± 1 SD. Data from different time intervals within groups were compared using Student's paired t-test. 25 patients completed the 4g cross-over study and 18 the 8g extension study. Curcumin therapy decreased the free light-chain ratio (rFLC), reduced the difference between clonal and nonclonal light-chain (dFLC) and involved free light-chain (iFLC). uDPYD, a marker of bone resorption, decreased in the curcumin arm and increased on the placebo arm. Serum creatinine levels tended to diminish on curcumin therapy. These findings suggest that curcumin might have the potential to slow the disease process in patients with MGUS and SMM. Copyright © 2012 Wiley Periodicals, Inc.

  2. A combination of acid lactase from Aspergillus oryzae and yogurt bacteria improves lactose digestion in lactose maldigesters synergistically: A randomized, controlled, double-blind cross-over trial.

    Science.gov (United States)

    de Vrese, Michael; Laue, Christiane; Offick, Birte; Soeth, Edlyn; Repenning, Frauke; Thoß, Angelika; Schrezenmeir, Jürgen

    2015-06-01

    Lactose digestion can be improved in subjects with impaired or completely absent intestinal lactase activity by administration of lactase preparations and particularly of acid lactase, which is active in the stomach, or by yogurt containing live lactic acid bacteria. It is the question, if lactose digestion can be further enhanced by combining these two approaches. We investigated in a randomised, placebo-controlled, double-blind, 5-arm crossover study on 24 lactose malabsorbers with variable degrees of lactase deficiency if different lactase preparations and freeze-dried yogurt culture affect gastrointestinal lactose digestion after consuming moderate amounts of lactose (12.5 g) by assessing hydrogen exhalation over 6 h. Furthermore, symptoms of lactose intolerance (excess gas production, abdominal pain, diarrhoea or nausea) were assessed using validated questionnaires. All preparations increased lactose digestion and reduced peak hydrogen exhalation by -27% (yogurt), -29/-33% (3300/9000 FCC(1) ((1) One FCC hydrolyses about 5 or 1.7-2.5 mg lactose in aquous solution or in (artificial) chyme, respectively, according to the FCC-III method of the Committee on Codex Specifications, Food and Nutrition Board, National Research Council. Food Chemicals Codex, 3rd edition. Washington, DC, National Academy Press, 1981 It cannot precisely be defined how much lactose can be hydrolysed in vivo by the consumption of a certain number of FCC units.) units acid lactase from Aspergillus oryzae) or -46%, respectively (3300 FCC units lactase plus yogurt culture combined), as compared with placebo (p lactose digestion more than either freeze-dried yogurt cultures or acid lactase alone, and more lactose malabsorbers benefited from this effect. Copyright © 2014. Published by Elsevier Ltd.

  3. A randomised, double-blind, placebo controlled cross-over study to determine the gastrointestinal effects of consumption of arabinoxylan-oligosaccharides enriched bread in healthy volunteers.

    Science.gov (United States)

    Walton, Gemma E; Lu, Congyi; Trogh, Isabel; Arnaut, Filip; Gibson, Glenn R

    2012-06-01

    Prebiotics are food ingredients, usually non-digestible oligosaccharides, that are selectively fermented by populations of beneficial gut bacteria. Endoxylanases, altering the naturally present cereal arabinoxylans, are commonly used in the bread industry to improve dough and bread characteristics. Recently, an in situ method has been developed to produce arabinoxylan-oligosaccharides (AXOS) at high levels in breads through the use of a thermophilic endoxylanase. AXOS have demonstrated potentially prebiotic properties in that they have been observed to lead to beneficial shifts in the microbiota in vitro and in murine, poultry and human studies. A double-blind, placebo controlled human intervention study was undertaken with 40 healthy adult volunteers to assess the impact of consumption of breads with in situ produced AXOS (containing 2.2 g AXOS) compared to non-endoxylanase treated breads. Volatile fatty acid concentrations in faeces were assessed and fluorescence in situ hybridisation was used to assess changes in gut microbial groups. Secretory immunoglobulin A (sIgA) levels in saliva were also measured. Consumption of AXOS-enriched breads led to increased faecal butyrate and a trend for reduced iso-valerate and fatty acids associated with protein fermentation. Faecal levels of bifidobacteria increased following initial control breads and remained elevated throughout the study. Lactobacilli levels were elevated following both placebo and AXOS-breads. No changes in salivary secretory IgA levels were observed during the study. Furthermore, no adverse effects on gastrointestinal symptoms were reported during AXOS-bread intake. AXOS-breads led to a potentially beneficial shift in fermentation end products and are well tolerated.

  4. A randomised, double-blind, placebo controlled cross-over study to determine the gastrointestinal effects of consumption of arabinoxylan-oligosaccharides enriched bread in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Walton Gemma E

    2012-06-01

    Full Text Available Abstract Background Prebiotics are food ingredients, usually non-digestible oligosaccharides, that are selectively fermented by populations of beneficial gut bacteria. Endoxylanases, altering the naturally present cereal arabinoxylans, are commonly used in the bread industry to improve dough and bread characteristics. Recently, an in situ method has been developed to produce arabinoxylan-oligosaccharides (AXOS at high levels in breads through the use of a thermophilic endoxylanase. AXOS have demonstrated potentially prebiotic properties in that they have been observed to lead to beneficial shifts in the microbiota in vitro and in murine, poultry and human studies. Methods A double-blind, placebo controlled human intervention study was undertaken with 40 healthy adult volunteers to assess the impact of consumption of breads with in situ produced AXOS (containing 2.2 g AXOS compared to non-endoxylanase treated breads. Volatile fatty acid concentrations in faeces were assessed and fluorescence in situ hybridisation was used to assess changes in gut microbial groups. Secretory immunoglobulin A (sIgA levels in saliva were also measured. Results Consumption of AXOS-enriched breads led to increased faecal butyrate and a trend for reduced iso-valerate and fatty acids associated with protein fermentation. Faecal levels of bifidobacteria increased following initial control breads and remained elevated throughout the study. Lactobacilli levels were elevated following both placebo and AXOS-breads. No changes in salivary secretory IgA levels were observed during the study. Furthermore, no adverse effects on gastrointestinal symptoms were reported during AXOS-bread intake. Conclusions AXOS-breads led to a potentially beneficial shift in fermentation end products and are well tolerated.

  5. Salvia Miltiorrhiza Root Water-Extract (Danshen Has No Beneficial Effect on Cardiovascular Risk Factors. A Randomized Double-Blind Cross-Over Trial.

    Directory of Open Access Journals (Sweden)

    Pleun C M van Poppel

    Full Text Available Danshen is the dried root extract of the plant Salvia Miltiorrhiza and it is used as traditional Chinese medicinal herbal product to prevent and treat atherosclerosis. However, its efficacy has not been thoroughly investigated. This study evaluates the effect of Danshen on hyperlipidemia and hypertension, two well known risk factors for the development of atherosclerosis.This was a randomized, placebo-controlled, double-blind crossover study performed at a tertiary referral center. Participants were recruited by newspaper advertisement and randomized to treatment with Danshen (water-extract of the Salvia Miltiorrhiza root or placebo for 4 consecutive weeks. There was a wash out period of 4 weeks. Of the 20 analysed participants, 11 received placebo first. Inclusion criteria were: age 40-70 years, hyperlipidemia and hypertension. At the end of each treatment period, plasma lipids were determined (primary outcome, 24 hours ambulant blood pressure measurement (ABPM was performed, and vasodilator endothelial function was assessed in the forearm.LDL cholesterol levels were 3.82±0.14 mmol/l after Danshen and 3.52±0.16 mmol/l after placebo treatment (mean±SE; p<0.05 for treatment effect corrected for baseline. Danshen treatment had no effect on blood pressure (ABPM 138/84 after Danshen and 136/87 after placebo treatment. These results were further substantiated by the observation that Danshen had neither an effect on endothelial function nor on markers of inflammation, oxidative stress, glucose metabolism, hemostasis and blood viscosity.Four weeks of treatment with Danshen (water-extract slightly increased LDL-cholesterol without affecting a wide variety of other risk markers. These observations do not support the use of Danshen to prevent or treat atherosclerosis.ClinicalTrials.gov NCT01563770.

  6. The Effect of Donepezil on Arousal Threshold and Apnea–Hypopnea Index. A Randomized, Double-Blind, Cross-Over Study

    Science.gov (United States)

    Li, Yanru; Owens, Robert L.; Sands, Scott; Orr, Jeremy; Moraes, Walter; DeYoung, Pamela; Smales, Erik; Jen, Rachel

    2016-01-01

    Rationale: Obstructive sleep apnea (OSA) has multiple pathophysiological causes. A low respiratory arousal threshold (ArTh) and a high loop gain (unstable ventilatory control) can contribute to recurrent respiratory events in patients with OSA. Prior studies have shown that donepezil, an acetylcholinesterase inhibitor, might improve OSA, but the mechanism is unknown. Objectives: To determine whether a single dose of donepezil lowers the apnea–hypopnea index by modulating the ArTh or loop gain. Methods: In this randomized, double-blind, crossover trial, 41 subjects with OSA underwent two polysomnograms with ArTh and loop gain evaluated, during which 10 mg of donepezil or placebo was administered. Measurements and Main Results: Compared with placebo, sleep efficiency (77.2 vs. 71.9%; P = 0.015) and total sleep time decreased with donepezil (372 vs. 351 min; P = 0.004). No differences were found in apnea–hypopnea index (51.8 vs. 50.0 events/h; P = 0.576) or nadir oxygen saturation as determined by pulse oximetry (80.3 vs. 81.1%; P = 0.241) between placebo and donepezil, respectively. ArTh was not significantly changed (–18.9 vs. –18.0 cm H2O; P = 0.394) with donepezil. As a whole group, loop gain (ventilatory response to a 1-cycle/min disturbance) did not change significantly (P = 0.089). Conclusions: A single dose of donepezil did not appear to affect the overall severity of OSA in this patient group, and no consistent effects on ArTh or loop gain were observed. Donepezil may have minor effects on sleep architecture. Clinical trial registered with www.clinicaltrials.gov (NCT02264353). PMID:27442715

  7. The Effect of Donepezil on Arousal Threshold and Apnea-Hypopnea Index. A Randomized, Double-Blind, Cross-Over Study.

    Science.gov (United States)

    Li, Yanru; Owens, Robert L; Sands, Scott; Orr, Jeremy; Moraes, Walter; DeYoung, Pamela; Smales, Erik; Jen, Rachel; Malhotra, Atul

    2016-11-01

    Obstructive sleep apnea (OSA) has multiple pathophysiological causes. A low respiratory arousal threshold (ArTh) and a high loop gain (unstable ventilatory control) can contribute to recurrent respiratory events in patients with OSA. Prior studies have shown that donepezil, an acetylcholinesterase inhibitor, might improve OSA, but the mechanism is unknown. To determine whether a single dose of donepezil lowers the apnea-hypopnea index by modulating the ArTh or loop gain. In this randomized, double-blind, crossover trial, 41 subjects with OSA underwent two polysomnograms with ArTh and loop gain evaluated, during which 10 mg of donepezil or placebo was administered. Compared with placebo, sleep efficiency (77.2 vs. 71.9%; P = 0.015) and total sleep time decreased with donepezil (372 vs. 351 min; P = 0.004). No differences were found in apnea-hypopnea index (51.8 vs. 50.0 events/h; P = 0.576) or nadir oxygen saturation as determined by pulse oximetry (80.3 vs. 81.1%; P = 0.241) between placebo and donepezil, respectively. ArTh was not significantly changed (-18.9 vs. -18.0 cm H 2 O; P = 0.394) with donepezil. As a whole group, loop gain (ventilatory response to a 1-cycle/min disturbance) did not change significantly (P = 0.089). A single dose of donepezil did not appear to affect the overall severity of OSA in this patient group, and no consistent effects on ArTh or loop gain were observed. Donepezil may have minor effects on sleep architecture. Clinical trial registered with www.clinicaltrials.gov (NCT02264353).

  8. Immediate Effects of Ankle Balance Taping with Kinesiology Tape for Amateur Soccer Players with Lateral Ankle Sprain: A Randomized Cross-Over Design.

    Science.gov (United States)

    Kim, Myoung Kwon; Shin, Young Jun

    2017-11-21

    BACKGROUND The objective of this study was to investigate the immediate effect on gait function when ankle balance taping is applied to amateur soccer players with lateral ankle sprain. MATERIAL AND METHODS A cross-over randomized design was used. Twenty-two soccer players with an ankle sprain underwent 3 interventions in a random order. Subjects were randomly assigned to ankle balance taping, placebo taping, and no taping groups. The assessment was performed using the GAITRite portable walkway system, which records the location and timing of each footfall during ambulation. RESULTS Significant differences were found in the velocity, step length, stride length, and H-H base support among the 3 different taping methods (pamateur soccer players with lateral ankle sprain. Therefore, ankle balance taping is a useful alternative to prevent and treat ankle sprain of soccer players.

  9. Peripheral pulsed electromagnetic fields may reduce the placebo effect in migraine patients that do not respond to the sham intervention in a randomized, placebo-controlled, double-blind, cross-over clinical trial.

    Science.gov (United States)

    San-Juan, Daniel; Pon, Ana Aurora L; Pohls, Fernando Z; Del Castillo-Calcáneo, Juan de Dios; Pérez-Neri, Iván; Ríos, Camilo

    2012-01-01

    The purpose of the study was to evaluate the effect of the pulsed electromagnetic fields (PEMF) and its possible modulation of the placebo effect in migraine. Placebo-controlled, randomized, double-blind, cross-over clinical trial. Government third level hospital. Patients with migraine were included. PEMF were applied to the wrist with a bracelet. Frequency and intensity of the migraine attacks at baseline and during treatment were recorded. Also, we valuated the possible influence of gender and the presence of aura in the PEMF and placebo responses. Eighteen patients (fifteen women, 30±2 years old) were included. Migraine frequency and intensity was reduced with both PEMF and placebo to a similar extent in the whole population. However, in responders to placebo, migraine intensity was reduced to a median of 100% with the placebo and to 60% with the PEMF, while in non-responders there was only a slight effect of both treatments. Our results do not suggest an influence of gender or presence of aura in the outcomes. Treatment with PEMF may not alter either migraine intensity or frequency compared to baseline, but may reduce the response to placebo in migraine patients. Copyright © 2011 Elsevier Ltd. All rights reserved.

  10. Habitual dietary fibre intake influences gut microbiota response to an inulin-type fructan prebiotic: a randomised, double-blind, placebo-controlled, cross-over, human intervention study.

    Science.gov (United States)

    Healey, Genelle; Murphy, Rinki; Butts, Christine; Brough, Louise; Whelan, Kevin; Coad, Jane

    2018-01-01

    Dysbiotic gut microbiota have been implicated in human disease. Diet-based therapeutic strategies have been used to manipulate the gut microbiota towards a more favourable profile. However, it has been demonstrated that large inter-individual variability exists in gut microbiota response to a dietary intervention. The primary objective of this study was to investigate whether habitually low dietary fibre (LDF) v. high dietary fibre (HDF) intakes influence gut microbiota response to an inulin-type fructan prebiotic. In this randomised, double-blind, placebo-controlled, cross-over study, thirty-four healthy participants were classified as LDF or HDF consumers. Gut microbiota composition (16S rRNA bacterial gene sequencing) and SCFA concentrations were assessed following 3 weeks of daily prebiotic supplementation (Orafti® Synergy 1; 16 g/d) or placebo (Glucidex® 29 Premium; 16 g/d), as well as after 3 weeks of the alternative intervention, following a 3-week washout period. In the LDF group, the prebiotic intervention led to an increase in Bifidobacterium (P=0·001). In the HDF group, the prebiotic intervention led to an increase in Bifidobacterium (Pinulin-type fructan prebiotic than those with LDF intakes. Future studies aiming to modulate the gut microbiota and improve host health, using an inulin-type fructan prebiotic, should take habitual dietary fibre intake into account.

  11. Computer classes and games in virtual reality environment to reduce loneliness among students of an elderly reference center: Study protocol for a randomised cross-over design.

    Science.gov (United States)

    Antunes, Thaiany Pedrozo Campos; Oliveira, Acary Souza Bulle de; Crocetta, Tania Brusque; Antão, Jennifer Yohanna Ferreira de Lima; Barbosa, Renata Thais de Almeida; Guarnieri, Regiani; Massetti, Thais; Monteiro, Carlos Bandeira de Mello; Abreu, Luiz Carlos de

    2017-03-01

    Physical and mental changes associated with aging commonly lead to a decrease in communication capacity, reducing social interactions and increasing loneliness. Computer classes for older adults make significant contributions to social and cognitive aspects of aging. Games in a virtual reality (VR) environment stimulate the practice of communicative and cognitive skills and might also bring benefits to older adults. Furthermore, it might help to initiate their contact to the modern technology. The purpose of this study protocol is to evaluate the effects of practicing VR games during computer classes on the level of loneliness of students of an elderly reference center. This study will be a prospective longitudinal study with a randomised cross-over design, with subjects aged 50 years and older, of both genders, spontaneously enrolled in computer classes for beginners. Data collection will be done in 3 moments: moment 0 (T0) - at baseline; moment 1 (T1) - after 8 typical computer classes; and moment 2 (T2) - after 8 computer classes which include 15 minutes for practicing games in VR environment. A characterization questionnaire, the short version of the Short Social and Emotional Loneliness Scale for Adults (SELSA-S) and 3 games with VR (Random, MoviLetrando, and Reaction Time) will be used. For the intervention phase 4 other games will be used: Coincident Timing, Motor Skill Analyser, Labyrinth, and Fitts. The statistical analysis will compare the evolution in loneliness perception, performance, and reaction time during the practice of the games between the 3 moments of data collection. Performance and reaction time during the practice of the games will also be correlated to the loneliness perception. The protocol is approved by the host institution's ethics committee under the number 52305215.3.0000.0082. Results will be disseminated via peer-reviewed journal articles and conferences. This clinical trial is registered at ClinicalTrials.gov identifier: NCT

  12. Effect of supplementation of fermented milk drink containing probiotic Lactobacillus casei Shirota on the concentrations of aflatoxin biomarkers among employees of Universiti Putra Malaysia: a randomised, double-blind, cross-over, placebo-controlled study.

    Science.gov (United States)

    Mohd Redzwan, Sabran; Abd Mutalib, Mohd Sokhini; Wang, Jia-Sheng; Ahmad, Zuraini; Kang, Min-Su; Abdul Rahman, Nurul 'Aqilah; Nikbakht Nasrabadi, Elham; Jamaluddin, Rosita

    2016-01-14

    Human exposure to aflatoxin is through the diet, and probiotics are able to bind aflatoxin and prevent its absorption in the small intestine. This study aimed to determine the effectiveness of a fermented milk drink containing Lactobacillus casei Shirota (LcS) (probiotic drink) to prevent aflatoxin absorption and reduce serum aflatoxin B1-lysine adduct (AFB1-lys) and urinary aflatoxin M1 concentrations. The present study was a randomised, double-blind, cross-over, placebo-controlled study with two 4-week intervention phases. In all, seventy-one subjects recruited from the screening stage were divided into two groups--the Yellow group and the Blue group. In the 1st phase, one group received probiotic drinks twice a day and the other group received placebo drinks. Blood and urine samples were collected at baseline, 2nd and 4th week of the intervention. After a 2-week wash-out period, the treatments were switched between the groups, and blood and urine samples were collected at the 6th, 8th and 10th week (2nd phase) of the intervention. No significant differences in aflatoxin biomarker concentrations were observed during the intervention. A within-group analysis was further carried out. Aflatoxin biomarker concentrations were not significantly different in the Yellow group. Nevertheless, ANOVA for repeated measurements indicated that AFB1-lys concentrations were significantly different (P=0·035) with the probiotic intervention in the Blue group. The 2nd week AFB1-lys concentrations (5·14 (SD 2·15) pg/mg albumin (ALB)) were significantly reduced (P=0·048) compared with the baseline (6·24 (SD 3·42) pg/mg ALB). Besides, the 4th week AFB1-lys concentrations were significantly lower (Pprobiotic supplementation than with the placebo. Based on these findings, a longer intervention study is warranted to investigate the effects of continuous LcS consumption to prevent dietary aflatoxin exposure.

  13. Impact of Virgin Olive Oil and Phenol-Enriched Virgin Olive Oils on the HDL Proteome in Hypercholesterolemic Subjects: A Double Blind, Randomized, Controlled, Cross-Over Clinical Trial (VOHF Study).

    Science.gov (United States)

    Pedret, Anna; Catalán, Úrsula; Fernández-Castillejo, Sara; Farràs, Marta; Valls, Rosa-M; Rubió, Laura; Canela, Núria; Aragonés, Gerard; Romeu, Marta; Castañer, Olga; de la Torre, Rafael; Covas, Maria-Isabel; Fitó, Montse; Motilva, Maria-José; Solà, Rosa

    2015-01-01

    The effects of olive oil phenolic compounds (PCs) on HDL proteome, with respect to new aspects of cardioprotective properties, are still unknown. The aim of this study was to assess the impact on the HDL protein cargo of the intake of virgin olive oil (VOO) and two functional VOOs, enriched with their own PCs (FVOO) or complemented with thyme PCs (FVOOT), in hypercholesterolemic subjects. Eligible volunteers were recruited from the IMIM-Hospital del Mar Medical Research Institute (Spain) from April 2012 to September 2012. Thirty-three hypercholesterolemic participants (total cholesterol >200 mg/dL; 19 men and 14 women; aged 35 to 80 years) were randomized in the double-blind, controlled, cross-over VOHF clinical trial. The subjects received for 3 weeks 25 mL/day of: VOO, FVOO, or FVOOT. Using a quantitative proteomics approach, 127 HDL-associated proteins were identified. Among these, 15 were commonly differently expressed after the three VOO interventions compared to baseline, with specific changes observed for each intervention. The 15 common proteins were mainly involved in the following pathways: LXR/RXR activation, acute phase response, and atherosclerosis. The three VOOs were well tolerated by all participants. Consumption of VOO, or phenol-enriched VOOs, has an impact on the HDL proteome in a cardioprotective mode by up-regulating proteins related to cholesterol homeostasis, protection against oxidation and blood coagulation while down-regulating proteins implicated in acute-phase response, lipid transport, and immune response. The common observed protein expression modifications after the three VOOs indicate a major matrix effect. International Standard Randomized Controlled Trials ISRCTN77500181.

  14. Effects of subacute ingestion of chlorogenic acids on sleep architecture and energy metabolism through activity of the autonomic nervous system: a randomised, placebo-controlled, double-blinded cross-over trial.

    Science.gov (United States)

    Park, Insung; Ochiai, Ryuji; Ogata, Hitomi; Kayaba, Momoko; Hari, Sayaka; Hibi, Masanobu; Katsuragi, Yoshihisa; Satoh, Makoto; Tokuyama, Kumpei

    2017-04-01

    Chlorogenic acids (CGA) are the most abundant polyphenols in coffee. Continuous consumption of CGA reduces body fat and body weight. Since energy metabolism and sleep are controlled by common regulatory factors, consumption of CGA might modulate sleep. Lack of sleep has been identified as a risk factor for obesity, hypertension and type 2 diabetes. The aim of this study was to determine the effects of ingesting CGA over 5 d on energy metabolism and sleep quality in humans. A total of nine healthy subjects (four male and five female) completed a placebo-controlled, double-blinded, cross-over intervention study. Subjects consumed a test beverage containing 0 or 600 mg of CGA for 5 d. On the fifth night, subjects stayed in a whole-room metabolic chamber to measure energy metabolism; sleep was evaluated using polysomnographic recording. It was found that CGA shortened sleep latency (9 (sem 2) v. 16 (sem 4) min, P<0·05) compared with the control, whereas no effect on sleep architecture, such as slow-wave sleep, rapid eye movement or waking after sleep onset, was observed. Indirect calorimetry revealed that consumption of CGA increased fat oxidation (510 (sem 84) kJ/8 h (122 (sem 20) kcal/8 h) v. 331 (sem 79) kJ/8 h (81 (sem 19) kcal/8 h), P<0·05) but did not affect energy expenditure during sleep. Consumption of CGA enhanced parasympathetic activity assessed from heart-rate variability during sleep (999 (sem 77) v. 919 (sem 54), P<0·05). A period of 5-d CGA consumption significantly increased fat oxidation during sleep, suggesting that beverages containing CGA may be beneficial to reduce body fat and prevent obesity. Consumption of CGA shortened sleep latency and did not adversely affect sleep quality.

  15. Influence of habitual dietary fibre intake on the responsiveness of the gut microbiota to a prebiotic: protocol for a randomised, double-blind, placebo-controlled, cross-over, single-centre study.

    Science.gov (United States)

    Healey, Genelle; Brough, Louise; Butts, Chrissie; Murphy, Rinki; Whelan, Kevin; Coad, Jane

    2016-09-02

    The commensal gut microbiota have been shown to have an impact on human health as aberrant gut microbiota have been linked to disease. Dietary constituents are influential in shaping the gut microbiota. Diet-specific therapeutic strategies may therefore play a role in optimising human health via beneficial manipulation of the gut microbiota. Research has suggested that an individual's baseline gut microbiota composition may influence how the gut microbiota respond to a dietary intervention and individuals with differing habitual dietary intakes appear to have distinct baseline gut microbiota compositions. The responsiveness of the gut microbiota may therefore be influenced by habitual dietary intakes. This study aims to investigate what influence differing habitual dietary fibre intakes have on the responsiveness of the gut microbiota to a prebiotic intervention. In this randomised, double-blind, placebo-controlled, cross-over, single-centre study, 20 low dietary fibre (dietary fibre intake gut microbiota composition (using 16S rRNA gene sequencing) and functional capacity (faecal short chain fatty acid concentrations and Phylogenetic Investigation of Communities by Reconstruction of Unobserved States (PICRUSt)) as well as appetite (visual analogue scale appetite questionnaire) will be assessed at the beginning and end of each intervention phase. The Massey University Human Ethics Committee approved this study (Massey University HEC: Southern A application-15/34). Results will be disseminated through peer-review journal publications, conference presentations and a summary of findings will be distributed to participants. ACTRN12615000922572; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  16. Impact of Virgin Olive Oil and Phenol-Enriched Virgin Olive Oils on the HDL Proteome in Hypercholesterolemic Subjects: A Double Blind, Randomized, Controlled, Cross-Over Clinical Trial (VOHF Study.

    Directory of Open Access Journals (Sweden)

    Anna Pedret

    Full Text Available The effects of olive oil phenolic compounds (PCs on HDL proteome, with respect to new aspects of cardioprotective properties, are still unknown. The aim of this study was to assess the impact on the HDL protein cargo of the intake of virgin olive oil (VOO and two functional VOOs, enriched with their own PCs (FVOO or complemented with thyme PCs (FVOOT, in hypercholesterolemic subjects. Eligible volunteers were recruited from the IMIM-Hospital del Mar Medical Research Institute (Spain from April 2012 to September 2012. Thirty-three hypercholesterolemic participants (total cholesterol >200 mg/dL; 19 men and 14 women; aged 35 to 80 years were randomized in the double-blind, controlled, cross-over VOHF clinical trial. The subjects received for 3 weeks 25 mL/day of: VOO, FVOO, or FVOOT. Using a quantitative proteomics approach, 127 HDL-associated proteins were identified. Among these, 15 were commonly differently expressed after the three VOO interventions compared to baseline, with specific changes observed for each intervention. The 15 common proteins were mainly involved in the following pathways: LXR/RXR activation, acute phase response, and atherosclerosis. The three VOOs were well tolerated by all participants. Consumption of VOO, or phenol-enriched VOOs, has an impact on the HDL proteome in a cardioprotective mode by up-regulating proteins related to cholesterol homeostasis, protection against oxidation and blood coagulation while down-regulating proteins implicated in acute-phase response, lipid transport, and immune response. The common observed protein expression modifications after the three VOOs indicate a major matrix effect.International Standard Randomized Controlled Trials ISRCTN77500181.

  17. 
Intrathecal analgesia by bupivacaine is not enhanced by coadministration of morphine in patients with severe cancer-related pain: a randomized double-blind cross-over study.

    Science.gov (United States)

    Reif, Ingalill; Wincent, Anders; Stiller, Carl-Olav

    2017-06-01

    The objective of this randomized double blind cross-over trial was to determine if patients with severe cancer-related pain and inadequate response to systemic opioids prefer intrathecal (IT) pain relief with a combination of bupivacaine and morphine or bupivacaine only. Adult patients with cancer-related pain (n = 23) scheduled for IT analgesia at the Pain Center at the Karo-linska University Hospital Solna, Stockholm, Sweden, were included. The optimal individual flow rate of IT bupivacaine (2 mg/mL) in addition to bolus doses was titrated and maintained for 4 days. Morphine (1 mg/mL) was added to bupivacaine either on day 2 or 4 according to a randomization protocol. Expression of pain relief preference for morphine instead of control (bupivacaine only) was the primary outcome. Secondary outcomes were difference in pain intensity, pain relief, total use of bupivacaine per 24 hours and number of requested bolus doses. Eight patients dropped out during the 4-day study period for reasons not related to the trial. IT bupivacaine significantly decreased median (interquartile range) pain intensity from 5 (3 - 7) at baseline (before catheter insertion) to 1 (0 - 1) (p = 0.0001; Wilcoxon test). Only 1 patient of 15 with 4-day data expressed any preference for morphine. The addition of IT morphine did not result in any significant change of pain intensity, pain relief score, total use of bupivacaine per 24 hours, or number of requested bolus doses. These results suggest that patients with cancer-related pain treated with high doses of systemic opioids, may start IT treatment with an optimal dose of IT bupivacaine without morphine.
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  18. Implementation of knowledge-based palliative care in nursing homes and pre-post post evaluation by cross-over design: a study protocol.

    Science.gov (United States)

    Ahlström, Gerd; Nilsen, Per; Benzein, Eva; Behm, Lina; Wallerstedt, Birgitta; Persson, Magnus; Sandgren, Anna

    2018-03-22

    The demography of the world is changing as the population is ageing. Because of this change to a higher proportion of older people, the WHO has called for improved palliative care for older persons. A large number of all deaths in the industrialised world occur while older people are living in nursing homes and therefore a key question becomes how the principles of palliative care can be implemented in that context. The aims of this study are: a) to describe a model of an educational intervention with the goal of implementing knowledge-based palliative care in nursing homes, and b) to describe the design of the evaluation of the effectiveness regarding the implementation of knowledge-based palliative care. A complex intervention is evaluated by means of a cross-over design. An educational intervention concerning palliative care consisting of five seminars during 6 months for staff and managers has been developed and conducted in 20 nursing homes in two counties. Before the intervention started, the feasibility was tested in a pilot study conducted in nursing homes not included in the main study. The intervention is evaluated through a non-randomized experimental design with intervention and control groups and pre- and post-assessments. The evaluation includes older persons living in nursing homes, next-of-kin, staff and managers. Data collection consists of quantitative methods such as questionnaires and register data and qualitative methods in the form of individual interviews, focus-group interviews and participant observations. The research will contribute to new knowledge about how to implement knowledge-based palliative care in a nursing home setting. A strength of this project is that the Medical Research Council framework of complex intervention is applied. The four recommended stages, Development, Feasibility and piloting, Evaluation and Implementation, are combined for the educational intervention, which functions as a strategy to achieve knowledge

  19. A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial: study rationale and design

    Directory of Open Access Journals (Sweden)

    Kristensen Peter

    2012-06-01

    Full Text Available Abstract Background Severe hypoglycaemia still represents a significant problem in insulin-treated diabetes. Most patients do not experience severe hypoglycaemia often. However, 20% of patients with type 1 diabetes experience recurrent severe hypoglycaemia corresponding to at least two episodes per year. The effect of insulin analogues on glycaemic control has been documented in large trials, while their effect on the frequency of severe hypoglycaemia is less clear, especially in patients with recurrent severe hypoglycaemia. The HypoAna Trial is designed to investigate whether short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing the occurrence of severe hypoglycaemic episodes in patients with recurrent hypoglycaemia. This paper reports the study design of the HypoAna Trial. Methods/design The study is a Danish two-year investigator-initiated, prospective, randomised, open, blinded endpoint (PROBE, multicentre, cross-over trial investigating the effect of insulin analogues versus human insulin on the frequency of severe hypoglycaemia in subjects with type 1 diabetes. Patients are randomised to treatment with basal-bolus therapy with insulin detemir / insulin aspart or human NPH insulin / human regular insulin in random order. The major inclusion criterion is history of two or more episodes of severe hypoglycaemia in the preceding year. Discussion In contrast to almost all other studies in this field the HypoAna Trial includes only patients with major problems with hypoglycaemia. The HypoAna Trial will elucidate whether basal-bolus regimen with short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing occurrence of severe hypoglycaemic episodes in hypoglycaemia prone patients with type 1 diabetes. http://www.clinicaltrials.gov: NCT00346996.

  20. Renal and Cardiovascular Effects of sodium-glucose cotransporter 2 (SGLT2) inhibition in combination with loop Diuretics in diabetic patients with Chronic Heart Failure (RECEDE-CHF): protocol for a randomised controlled double-blind cross-over trial.

    Science.gov (United States)

    Mordi, Natalie A; Mordi, Ify R; Singh, Jagdeep S; Baig, Fatima; Choy, Anna-Maria; McCrimmon, Rory J; Struthers, Allan D; Lang, Chim C

    2017-10-16

    Type 2 diabetes (T2D) and heart failure (HF) are a frequent combination, where treatment options remain limited. There has been increasing interest around the sodium-glucose cotransporter 2 (SGLT2) inhibitors and their use in patients with HF. Data on the effect of SGLT2 inhibitor use with diuretics are limited. We hypothesise that SGLT2 inhibition may augment the effects of loop diuretics and the benefits of SGLT2 inhibitors may extend beyond those of their metabolic (glycaemic parameters and weight loss) and haemodynamic parameters. The effects of SGLT2 inhibitors as an osmotic diuretic and on natriuresis may underlie the cardiovascular and renal benefits demonstrated in the recent EMPA-REG study. To assess the effect of SGLT2 inhibitors when used in combination with a loop diuretic, the RECEDE-CHF (Renal and Cardiovascular Effects of SGLT2 inhibition in combination with loop Diuretics in diabetic patients with Chronic Heart Failure) trial is a single-centre, randomised, double-blind, placebo-controlled, cross-over trial conducted in a secondary care setting within NHS Tayside, Scotland. 34 eligible participants, aged between 18 and 80 years, with stable T2D and CHF will be recruited. Renal physiological testing will be performed at two points (week 1 and week 6) on each arm to assess the effect of 25 mg empagliflozin, on the primary and secondary outcomes. Participants will be enrolled in the trial for a total period between 14 and 16 weeks. The primary outcome will assess the effect of empagliflozin versus placebo on urine output. The secondary outcomes are to assess the effect of empagliflozin on glomerular filtration rate, cystatin C, urinary sodium excretion, urinary protein/creatinine ratio and urinary albumin/creatinine ratio when compared with placebo. Ethics approval was obtained by the East of Scotland Research Ethics Service. Results of the trial will be submitted for publication in a peer-reviewed journal. NCT03226457; Pre-results. © Article author

  1. A randomised controlled cross-over double-blind pilot study protocol on THC:CBD oromucosal spray efficacy as an add-on therapy for post-stroke spasticity.

    Science.gov (United States)

    Marinelli, Lucio; Balestrino, Maurizio; Mori, Laura; Puce, Luca; Rosa, Gian Marco; Giorello, Laura; Currà, Antonio; Fattapposta, Francesco; Serrati, Carlo; Gandolfo, Carlo; Abbruzzese, Giovanni; Trompetto, Carlo

    2017-09-07

    Stroke is the most disabling neurological disorder and often causes spasticity. Transmucosal cannabinoids (tetrahydrocannabinol and cannabidiol (THC:CBD), Sativex) is currently available to treat spasticity-associated symptoms in patients with multiple sclerosis. Cannabinoids are being considered useful also in the treatment of pain, nausea and epilepsy, but may bear and increased risk for cardiovascular events. Spasticity is often assessed with subjective and clinical rating scales, which are unable to measure the increased excitability of the monosynaptic reflex, considered the hallmark of spasticity. The neurophysiological assessment of the stretch reflex provides a precise and objective method to measure spasticity. We propose a novel study to understand if Sativex could be useful in reducing spasticity in stroke survivors and investigating tolerability and safety by accurate cardiovascular monitoring. We will recruit 50 patients with spasticity following stroke to take THC:CBD in a double-blind placebo-controlled cross-over study. Spasticity will be assessed with a numeric rating scale for spasticity, the modified Ashworth scale and with the electromyographical recording of the stretch reflex. The cardiovascular risk will be assessed prior to inclusion. Blood pressure, heart rate, number of daily spasms, bladder function, sleep disruption and adverse events will be monitored throughout the study. A mixed-model analysis of variance will be used to compare the stretch reflex amplitude between the time points; semiquantitative measures will be compared using the Mann-Whitney test (THC:CBD vs placebo) and Wilcoxon test (baseline vs treatment). The study was registered on the EudraCT database with number 2016-001034-10 and approved by both the Italian Medicines Agency (Agenzia Italiana del Farmaco) and local Ethics Committee 'Comitato Etico Regionale della Liguria'. Data will be made anonymous and uploaded to a open access repository. Results will be disseminated

  2. Effects of a 6-month multimodal training intervention on retention of functional fitness in older adults: A randomized-controlled cross-over design

    Directory of Open Access Journals (Sweden)

    Gudlaugsson Janus

    2012-09-01

    Full Text Available Abstract Background Older adults have the highest rates of disability, functional dependence and use of healthcare resources. Training interventions for older individuals are of special interest where regular physical activity (PA has many health benefits. The main purpose of this study was to assess the immediate and long-term effects of a 6-month multimodal training intervention (MTI on functional fitness in old adults. Methods For this study, 117 participants, 71 to 90 years old, were randomized in immediate intervention group and a control group (delayed intervention group. The intervention consisted of daily endurance and twice-a-week strength training. The method was based on a randomized-controlled cross-over design. Short Physical Performance Battery (SPPB, 8 foot up-and-go test, strength performance, six min walking test (6 MW, physical activity, BMI and quality of life were obtained at baseline, after a 6-month intervention- and control phase, again after 6-month crossover- and delayed intervention phase, and after anadditional 6-month follow-up. Results After 6 months of MTI, the intervention group improved in physical performance compared with the control group via Short Physical Performance Battery (SPPB score (mean diff = 0.6, 95 % CI: 0.1, 1.0 and 8-foot up-and-go test (mean diff = −1.0 s, 95 % CI: -1.5, -0.6, and in endurance performance via 6-minute walking test (6 MW (mean diff = 44.2 meters, 95 % CI: 17.1, 71.2. In strength performance via knee extension the intervention group improved while control group declined (mean diff = 55.0 Newton, 95 % CI: 28.4, 81.7, and also in PA (mean diff = 125.9 cpm, 95 % CI: 96.0, 155.8. Long-term effects of MTI on the particpants was assesed by estimating the mean difference in the variables measured between time-point 1 and 4: SPPB (1.1 points, 95 % CI: 0.8, 1.4; 8-foot up-and-go (−0.9 s, 95 % CI: -1.2, -0.6; 6 MW (18.7 m, 95 % CI: 6.5, 31.0; knee extension (4.2 Newton

  3. Extra virgin olive oil phenols and markers of oxidation in Greek smokers: a randomized cross-over study

    NARCIS (Netherlands)

    Moschandreas, J.; Vissers, M.N.; Wiseman, S.; Putte, van K.P.; Kafatos, A.

    2002-01-01

    Objective: To examine the effect of a low phenol olive oil and high phenol olive oil on markers of oxidation and plasma susceptibility to oxidation in normolipaemic smokers. Design: Randomized single-blind cross-over trial with two intervention periods. Setting: The Medical School and University

  4. Effects of a wheat bran extract containing arabinoxylan oligosaccharides on gastrointestinal health parameters in healthy adult human volunteers : a double-blind, randomised, placebo-controlled, cross-over trial

    NARCIS (Netherlands)

    Francois, Isabelle E. J. A.; Lescroart, Olivier; Veraverbeke, Wim S.; Marzorati, Massimo; Possemiers, Sam; Evenepoel, Pieter; Hamer, Henrike; Houben, Els; Windey, Karen; Welling, Gjalt W.; Delcour, Jan A.; Courtin, Christophe M.; Verbeke, Kristin; Broekaert, Willem F.

    2012-01-01

    Wheat bran extract (WBE) is a food-grade soluble fibre preparation that is highly enriched in arabinoxylan oligosaccharides. In this placebo-controlled cross-over human intervention trial, tolerance and effects on colonic protein and carbohydrate fermentation were studied. After a 1-week run-in

  5. Early bronchodilator action of glycopyrronium versus tiotropium in moderate-to-severe COPD patients: a cross-over blinded randomized study (Symptoms and Pulmonary function in the moRnING

    Directory of Open Access Journals (Sweden)

    Marin JM

    2016-06-01

    Full Text Available Jose M Marin,1 Kai M Beeh,2 Andreas Clemens,3 Walter Castellani,4 Lennart Schaper,5 Dinesh Saralaya,6 Anthony Gunstone,7 Ricard Casamor,8 Konstantinos Kostikas,3 Maryam Aalamian-Mattheis3 1University Hospital Miguel Servet, IISAragón, CIBERES, Zaragoza, Spain; 2Insaf Respiratory Research Institute, Wiesbaden, Germany; 3Novartis Pharma AG, Basel, Switzerland; 4Hospital Piero Palagi, Fiorenze, Italy; 5Research Institute and Practice, Berlin-Brandenburg, Germany; 6Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK; 7Staploe Medical Center, Soham, Cambridge, UK; 8Novartis Farmaceutica SA, Barcelona, Spain Background: Morning symptoms associated with COPD have a negative impact on patients’ quality of life. Long-acting bronchodilators with rapid onset may relieve patients’ symptoms. In the Symptoms and Pulmonary function in the moRnING study, we prospectively compared the rapid onset bronchodilator profile of glycopyrronium (GLY and tiotropium (TIO during the first few hours after dosing in patients with moderate-to-severe COPD.Methods: Patients were randomized (1:1 to receive either once-daily GLY (50 µg or TIO (18 µg and corresponding placebos in a cross-over design for 28 days. The primary objective was to demonstrate the superiority of GLY versus TIO in area under the curve from 0 to 4 hours (AUC0-4h forced expiratory volume in 1 second (FEV1 after the first dose. The secondary objective was to compare GLY versus TIO using the patient reported outcomes Morning COPD Symptoms Questionnaire 3 hours post-inhalation.Results: One-hundred and twenty-six patients were randomized (male 70.2%; mean age 65.7 years and 108 patients completed the study. On Day 1, GLY resulted in significantly higher FEV1 AUC0-4h after the first dose versus TIO (treatment difference [Δ], 0.030 L, 95% confidence interval 0.004–0.056, P=0.025. Improvements in morning COPD symptoms from baseline at Days 1 and 28 were similar between GLY and TIO. Post hoc

  6. Liraglutide suppresses postprandial triglyceride and apolipoprotein B48 elevations after a fat-rich meal in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, cross-over trial.

    Science.gov (United States)

    Hermansen, K; Bækdal, T A; Düring, M; Pietraszek, A; Mortensen, L S; Jørgensen, H; Flint, A

    2013-11-01

    Postprandial triglyceridaemia is a risk factor for cardiovascular disease (CVD). This study investigated the effects of steady-state liraglutide 1.8 mg versus placebo on postprandial plasma lipid concentrations after 3 weeks of treatment in patients with type 2 diabetes mellitus (T2DM). In a cross-over trial, patients with T2DM (n = 20, 18-75 years, BMI 18.5-40 kg/m²) were randomized to once-daily subcutaneous liraglutide (weekly dose escalation from 0.6 to 1.8 mg) and placebo. After each 3-week period, a standardized fat-rich meal was provided, and the effects of liraglutide on triglyceride (primary endpoint AUC(0-8h)), apolipoprotein B48, non-esterified fatty acids, glycaemic responses and gastric emptying were assessed. ClinicalTrials.gov ID: NCT00993304. Novo Nordisk A/S. After 3 weeks, mean postprandial triglyceride (AUC(0-8h) liraglutide/placebo treatment-ratio 0.72, 95% CI [0.62-0.83], p = 0.0004) and apolipoprotein B48 (AUC(0-8h) ratio 0.65 [0.58-0.73], p postprandial glucose and glucagon AUC(0-8h) and C(max) were significantly reduced with liraglutide versus placebo. Postprandial gastric emptying rate [assessed by paracetamol absorption (liquid phase) and the ¹³C-octanoate breath test (solid phase)] displayed no treatment differences. Mean low-density lipoprotein and total cholesterol decreased significantly with liraglutide versus placebo. Liraglutide treatment in patients with T2DM significantly reduced postprandial excursions of triglyceride and apolipoprotein B48 after a fat-rich meal, independently of gastric emptying. Results indicate liraglutide's potential to reduce CVD risk via improvement of postprandial lipaemia. © 2013 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

  7. The effects of melatonin on sleep-wake rhythm of daytime haemodialysis patients: A randomized, placebo-controlled, cross-over study (EMSCAP study)

    NARCIS (Netherlands)

    Koch, B.C.P.; Nagtegaal, J.E.; Hagen, E.C.; van der Westerlaken, M.M.L; Boringa, J.B.S.; Kerkhof, G.A.; ter Wee, P.M.

    2009-01-01

    AIM: The aim of this study was to investigate the effects of exogenous melatonin on sleep-wake rhythm in haemodialysis patients. METHODS: The study design is a randomized, double-blind, placebo-controlled, cross-over study of 3 ¥ 6 weeks melatonin 3 mg at 22.00 h every night. Haemodialysis patients

  8. Comparison of oxygen uptake during cycle ergometry with and without functional electrical stimulation in patients with COPD: protocol for a randomised, single-blind, placebo-controlled, cross-over trial.

    Science.gov (United States)

    Medrinal, Clément; Prieur, Guillaume; Debeaumont, David; Robledo Quesada, Aurora; Combret, Yann; Quieffin, Jean; Contal, Olivier; Lamia, Bouchra

    2016-01-01

    Chronic obstructive pulmonary disease (COPD) has systemic repercussions that can lead to peripheral muscle dysfunction. Muscle atrophy reduces aerobic capacity, greatly limiting activities of daily living and quality of life. Pulmonary rehabilitation is the gold standard treatment for these patients, however, patients may not be able to reach sufficient training intensities for benefits to occur. Technologies such as functional electrical stimulation (FES) are currently being adapted and tested to enhance exercise training. We hypothesise that FES coupled with cycling (FES-cycling) will improve maximal uptake of oxygen (VO2) and aerobic capacity more than endurance training with placebo stimulation. A randomised, single-blind, placebo-controlled crossover trial will be carried out to evaluate the effects of FES-cycling on VO2 during endurance exercise on a cycle ergometer in patients with COPD. 25 patients with COPD will carry out two 30 min sessions at a constant load; one session with active and one with placebo FES. The primary outcome is oxygen uptake recorded with a metabolic measurement system. Secondary outcomes include ventilation equivalent for oxygen, ventilation equivalent for carbon dioxide, cardiac output, lactate values, perceived dyspnoea and perceived muscle fatigue. Approval has been granted by our Institutional Review Board (Comité de Protection des Personnes Nord-Ouest 3). The results of the trial will be presented at national and international meetings and published in peer-reviewed journals. NCT02594722.

  9. A double-blind cross-over controlled study to evaluate the effect of human biosynthetic growth hormone on ovarian stimulation in previous poor responders to in-vitro fertilization.

    Science.gov (United States)

    Hughes, S M; Huang, Z H; Morris, I D; Matson, P L; Buck, P; Lieberman, B A

    1994-01-01

    The effect of exogenous human biosynthetic growth hormone (HGH; 12 IU/day; Norditropin, Novo-Nordisk) on the response to ovarian stimulation using a buserelin/human menopausal gonadotrophin (HMG) regimen was assessed in women who had previously shown a 'poor response' in spite of increasing doses of HMG. Forty patients were recruited into a prospective double-blind placebo-controlled study. The serum follicle stimulating hormone (FSH) on day 2-5 of a menstrual cycle (HGH compared to the placebo cycle resulted in increased serum concentrations of fasting insulin on the 8th (median 3.9 versus 5.8 mU/l; P HGH. After 8 days of co-treatment with HGH the number of cohort follicles (14-16.9 mm) was significantly increased, but this change was not sustained on the day of HCG administration. No statistical difference in the serum oestradiol on the 8th day of HMG or day of HCG, length of the follicular phase, total dose of HMG used, or the number of oocytes collected was seen between the placebo or HGH cycles. This study demonstrates that HGH does not improve the ovarian response to ovulation induction in previous poor responders.

  10. Improvement in exercise duration, lung function and well-being in G551D-cystic fibrosis patients: a double-blind, placebo-controlled, randomized, cross-over study with ivacaftor treatment.

    Science.gov (United States)

    Edgeworth, Deirdre; Keating, Dominic; Ellis, Matthew; Button, Brenda; Williams, Elyssa; Clark, Denise; Tierney, Audrey; Heritier, Stephane; Kotsimbos, Tom; Wilson, John

    2017-08-01

    G551D, a mutation of the cystic fibrosis transmembrane conductance regulator (CFTR) gene, results in impaired chloride channel function in cystic fibrosis (CF) with multiple end-organ manifestations. The effect of ivacaftor, a CFTR-potentiator, on exercise capacity in CF is unknown. Twenty G551D-CF patients were recruited to a single-centre, double-blind, placebo-controlled, 28-day crossover study of ivacaftor. Variables measured included percentage change from baseline (%Δ) of V O 2 max (maximal oxygen consumption, primary outcome) during cardiopulmonary exercise testing (CPET), relevant other CPET physiological variables, lung function, body mass index (BMI), sweat chloride and disease-specific health related quality of life (QOL) measures (CFQ-R and Alfred Wellness (AWEscore)). %Δ V O 2 max was unchanged compared with placebo as was %Δminute ventilation. However, %Δexercise time (mean 7.3, CI 0.5-14,1, P =0.0222) significantly increased as did %ΔFEV 1 (11.7%, range 5.3-18.1, P <0·005) and %ΔBMI (1.2%, range 0.1-2.3, P =0·0393) whereas sweat chloride decreased (mean -43.4; range -55.5-18.1 mmol·l -1 , P <0·005). Total and activity based domains in both CFQ-R and AWEscore also increased. A positive treatment effect on spirometry, BMI (increased), SCT (decreased) and total and activity based CF-specific QOL measures was expected. However, the lack of discernible improvement in V O 2 max and VE despite other positive changes including spirometric lung function and exercise time with a 28-day ivacaftor intervention suggests that ventilatory parameters are not the sole driver of change in exercise capacity in this study cohort. Investigation over a more prolonged period may delineate the potential interdependencies of the observed discordances over time. ClinicalTrials.gov-NCT01937325. © 2017 The Author(s). Published by Portland Press Limited on behalf of the Biochemical Society.

  11. A novel Blind Start study design to investigate vestronidase alfa for mucopolysaccharidosis VII, an ultra-rare genetic disease.

    Science.gov (United States)

    Harmatz, Paul; Whitley, Chester B; Wang, Raymond Y; Bauer, Mislen; Song, Wenjie; Haller, Christine; Kakkis, Emil

    2018-02-12

    Drug development for ultra-rare diseases is challenging because small sample sizes and heterogeneous study populations hamper the ability of randomized, placebo-controlled trials with a single primary endpoint to demonstrate valid treatment effects. To overcome these challenges, a novel Blind Start design was utilized in a study of vestronidase alfa in mucopolysaccharidosis VII (Sly syndrome), an ultra-rare lysosomal disease, that demonstrates the strengths of this approach in a challenging drug-development setting. Twelve subjects were randomized to 1 of 4 blinded groups, each crossing over to active treatment in a blinded fashion at different timepoints with efficacy analysis comparing the last assessment before cross over to after 24 weeks of treatment. Study assessments included: Percentage change from baseline in urinary GAG (uGAG); a Multi-Domain Responder Index (MDRI) using prespecified minimal important differences (6-Minute Walk Test, Forced Vital Capacity, shoulder flexion, visual acuity, and Bruininks-Oseretsky Test of Motor Proficiency); fatigue as assessed by the Pediatric Quality of Life Inventory™ Multidimensional Fatigue Scale; and safety. Vestronidase alfa treatment for 24 weeks significantly reduced uGAG excretion (dermatan sulfate: 64.8%, p design improve statistical power that enhances detection of a positive treatment effect in this rare heterogeneous disease and could be utilized for other ultra-rare diseases. Copyright © 2018 Ultragenyx Pharmaceutical Inc. Published by Elsevier Inc. All rights reserved.

  12. Blindness

    Science.gov (United States)

    ... Specific Prevalence Rates for Blindness by Age and Race/Ethnicity Table for 2010 U.S. Age-Specific Prevalence ... Race/Ethnicity 2010 Prevalence Rates of Blindness by Race Table for 2010 Prevalence Rates of Blindness by ...

  13. Escitalopram in painful polyneuropathy: A randomized, placebo-controlled, cross-over trial

    DEFF Research Database (Denmark)

    Otto, Marit; Bach, Flemming W; Jensen, Troels S

    2008-01-01

    Serotonin (5-HT) is involved in pain modulation via descending pathways in the central nervous system. The aim of this study was to test if escitalopram, a selective serotonin reuptake inhibitor (SSRI), would relieve pain in polyneuropathy. The study design was a randomized, double-blind, placebo......-controlled cross-over trial. The daily dose of escitalopram was 20mg once daily. During the two treatment periods of 5 weeks duration, patients rated pain relief (primary outcome variable) on a 6-point ordered nominal scale. Secondary outcome measures comprised total pain and different pain symptoms (touch...... in the data analysis. Patients reported a better pain relief during treatment with escitalopram compared with placebo (p=0.001). Total pain and different pain symptoms were lower during escitalopram treatment (p=0.001-0.024). The Number needed to treat (NNT) to obtain one patient with good or complete pain...

  14. Muscle: The Tactile Texture Designed for the Blind

    OpenAIRE

    Chantana Insra

    2014-01-01

    The research objective focuses on creating a prototype media of the tactile texture of muscles for educational institutes to help visually impaired students learn massage extra learning materials further than the ordinary curriculum. This media is designed as an extra learning material. The population in this study was 30 blinded students between 4th - 6th grades who were able to read Braille language. The research was conducted during the second semester in 2012 at The B...

  15. Importance of architectural design in libraries for the blind

    Directory of Open Access Journals (Sweden)

    Sara Jalalzadeh

    2014-02-01

    Full Text Available Since the  principal aim of libraries is to provide services to the whole of society in the form of diffusing culture, an accurate management of these structures implies recognizing the needs and characteristics of its users, in order to construct buildings that are able to offer appropriate and efficient services. The blind and visually impaired are potential and actual users of libraries too, so their physical conditions should be considered prior to construction and therefore, in planning the interior design of the library building and space. The most important factors to be considered in library design in order to make them more easily accessible for this kind of user should include: designing an appropriate entrance, defining motion axes to aid movement inside the library, paying attention to library flooring, building reference shelves at an appropriate height, adequately arranging space found between resource shelves, allocating spaces for the blind to study in and facilitating access to adjacent areas inside the library. If all these conditions and requirements are met and applied in the architectural design and building of libraries, their use by this group of users will consequently be optimized.

  16. Blindness

    Science.gov (United States)

    ... doctors may do surgery to remove it. Is Learning Different? A baby who is blind can still ... do amazing things in many different fields, including music, the arts, and even sports. Serious vision problems ...

  17. Design and rationale for the WARFA trial: a randomized controlled cross-over trial testing the therapeutic equivalence of branded and generic warfarin in atrial fibrillation patients in Brazil.

    Science.gov (United States)

    Freitas, Carolina Gomes; Walsh, Michael; Atallah, Álvaro Nagib

    2017-06-07

    Warfarin is a commonly used anticoagulant. Whether a given dose of the different formulations of Brazilian warfarin will result in the same effect on the international normalized ratio (INR) is uncertain. The aim of the WARFA trial is to determine whether the branded and two generic warfarins available in Brazil differ in their effect on the INR. WARFA is a cross-over RCT comparing three warfarins. The formulations tested are the branded Marevan® (Uniao Quimica/Farmoquimica) and two generic warfarin (manufactured respectively by Uniao Quimica Farmaceutica Nacional and Laboratorio Teuto Brasileiro). All of them were manufactured in Brazil, are available in all settings of the Brazilian healthcare system and were purchased from retail drugstores. Eligible participants had atrial fibrillation or flutter, had been using warfarin for at least 2 months with a therapeutic range of 2.0-3.0 and had low variability in INR results during the 1st period of the trial. Our primary outcome, for which we have an equality hypothesis, is the difference between warfarins in the mean absolute difference between two INR results, obtained after three and 4 weeks with each drug. Our secondary outcomes, that will be tested for inequality (except for the mean INR, which will be tested for equality), include the difference in the warfarin dose, and time in therapeutic range. Clinical events and adherence were also recorded and will be reported. To our knowledge, WARFA will be the first comparison of the more readily applicable INR results between branded and generic warfarins in Brazil. WARFA is important because warfarins are commonly switched between in the course of a chronic treatment in Brazil. Final results of WARFA are expected in May 2017. ClinicalTrials.gov NCT02017197 . Registered 11 December 2013.

  18. From cars to bikes - the feasibility and effect of using e-bikes, longtail bikes and traditional bikes for transportation among parents of children attending kindergarten: design of a randomized cross-over trial.

    Science.gov (United States)

    Bjørnarå, Helga Birgit; Berntsen, Sveinung; Te Velde, Saskia J; Fegran, Liv; Fyhri, Aslak; Deforche, Benedicte; Andersen, Lars Bo; Bere, Elling

    2017-12-28

    The present study aims to increase bicycling and level of physical activity (PA), and thereby promote health in parents of toddlers, by giving access to different bicycle types. There is a need for greater understanding of e-bikes and their role in the transportation network, and further effects on PA levels and health. Moreover, longtail bikes could meet certain practical needs not fulfilled by e-bikes or traditional bikes, hence increased knowledge regarding their feasibility should be obtained. No previous studies have investigated whether providing an e-bike or a longtail bike over an extended period in a sample of parents of toddlers influence objectively assessed amount of bicycling and total PA level, transportation habits, cardiorespiratory fitness, body composition and blood pressure. A randomized cross-over trial will be performed, entailing that participants in the intervention group (n = 18) complete the following intervention arms in random order: (i) three months access to an e-bicycle with trailer for child transportation (n = 6), (ii) three months access to a longtail bicycle (n = 6), and (iii) three months access to a regular bicycle with trailer (n = 6), in total nine months. Also, a control group (n = 18) maintaining usual transportation and PA habits will be included. A convenience sample consisting of 36 parents of toddlers residing in Kristiansand municipality, Southern Norway, will be recruited. Total amount of bicycling (distance and time), total level of PA, and transportation habits will be measured at baseline and in connection to each intervention arm. Cardiorespiratory fitness, body composition and blood pressure will be measured at baseline and post-intervention. Main outcome will be bicycling distance and time spent cycling. New knowledge relevant for the timely issues of public health and environmental sustainability will be provided among parents of toddlers, representing a target group of greatest importance

  19. MOBIC: Designing a Travel Aid for Blind and Elderly People

    Science.gov (United States)

    Petrie, Helen; Johnson, Valerie; Strothotte, Thomas; Raab, Andreas; Fritz, Steffi; Michel, Rainer

    This paper presents the research for the development of a new travel aid to increase the independent mobility of blind and elderly travellers. This aid will build on the technologies of geographical information systems (GIS) and the Global Positioning System (GPS). The MOBIC Travel Aid (MOTA) consists of two interrelated components: the MOBIC Pre-journey System (MOPS) to assist users in planning journeys and the MOBIC Outdoor System (MOODS) to execute these plans by providing users with orientation and navigation assistance during journeys. The MOBIC travel aid is complementary to primary mobility aids such as the long cane or guide dog. Results of a study of user requirements are presented and their implications for the initial design of the system are discussed.

  20. Replacement fluids in plasmapheresis: cross-over comparative study.

    Science.gov (United States)

    Le Conte, P; Nicolas, F; Adjou, C; N'Guyen, J M; Billaud, E; Moreau, P

    1997-03-01

    To compare the tolerance and the cost of three replacement fluids in plasmapheresis: albumin 4% alone, albumin 4% + dextran 40, or albumin 4% + hydroxyethylstarch 6%. A one center randomized, cross-over, comparative study designed to explore the tolerance and the colloid oncotic pressure in patients undergoing plasmapheresis. 225 plasmapheresis procedures were performed in 27 patients. Hemodynamic tolerance was good in the three treatment groups. Serum protein concentration after plasmapheresis was significantly lower in the albumin + hydroxyethylstarch group, followed by albumin + dextran 40, versus albumin alone. Colloid oncotic pressure before and after exchange was similar in the three groups. The clinical use of 25-30% of hydroxyethylstarch 6% or dextran 40 with albumin 4% was clinically well tolerated and associated with a 12% decrease of the cost of substitution solutions.

  1. Designing for an inclusive school of informatics for blind students

    DEFF Research Database (Denmark)

    Vargas Brenes, Ronald

    environments in the inclusion process. The research has showed the significance of their participation in the educational context for their learning processes and professional futures. The research proposes a repertoire to define: A general and pragmatic categorisation of blindness: blind people who rely...... inclusion processes, defined by three levels: the entry level, the level of getting into inclusion level and the desired level of inclusion. Under these classifications it was determined that the educational environments related to the fieldwork were at the entry level, and the initiatives in those contexts...... the understanding of blindness and for easing the negotiability of practices between different populations. Therefore, this strategy contributes to the inclusion of blind students in these educational environments. Specialised offices in each university will benefit the incorporation of policies, knowledge...

  2. Magic with moulds: Meiotic and mitotic crossing over in Neurospora ...

    Indian Academy of Sciences (India)

    2006-02-16

    Feb 16, 2006 ... Home; Journals; Journal of Biosciences; Volume 31; Issue 1. Commentary: Magic with moulds: Meiotic and mitotic crossing over in Neurospora inversions and duplications. Durgadas P Kasbekar. Volume 31 Issue 1 March 2006 pp 3-4 ...

  3. Commentary: Magic with moulds: Meiotic and mitotic crossing over ...

    Indian Academy of Sciences (India)

    2006-02-16

    Feb 16, 2006 ... Home; Journals; Journal of Biosciences; Volume 31; Issue 1. Commentary: Magic with moulds: Meiotic and mitotic crossing over in Neurospora inversions and duplications. Durgadas P Kasbekar. Volume 31 Issue 1 March 2006 pp 3-4 ...

  4. The sphaleron rate through the electroweak cross-over

    DEFF Research Database (Denmark)

    D'Onofrio, Michela; Rummukainen, Kari; Tranberg, Anders

    2012-01-01

    Using lattice simulations, we measure the sphaleron rate in the Standard Model as a function of temperature through the electroweak cross-over, for the Higgs masses m(H) = 115 and m(H) = 160GeV. We pay special attention to the shutting off of the baryon rate as the temperature is lowered...... of the sphaleron rate at very high temperature, through the electroweak cross-over transition, and deep into the broken phase....

  5. The anticonvulsant levetiracetam for the treatment of pain in polyneuropathy: A randomized, placebo-controlled, cross-over trial

    DEFF Research Database (Denmark)

    Holbech, Jakob V; Otto, Marit; Bach, Flemming Winther

    2011-01-01

    of this study was to test the analgesic effect of levetiracetam in painful polyneuropathy. METHODS: This was a randomized, double-blind, placebo-controlled, cross-over trial with levetiracetam 3000mg/day versus placebo (6-week treatment periods). Patients with diagnosed polyneuropathy and symptoms for more than...

  6. Design of An Electronic Narrator on Assistant Robot for Blind People

    Directory of Open Access Journals (Sweden)

    Ardiansyah Rizqi Andry

    2016-01-01

    Full Text Available Many personal service robot is developed to help blind people in daily life, such as room cleaning, for navigating, object finding, reading and other activities. In this context, the present work focuses the development of an image-to-speech application for the blind. The project is called Design of An Electronic Narrator on Assistant Robot for Blind People, and the final purpose is the design of an electronic narrator application on personal service robot that helps to narrate a text on a book, magazine, a sheet of paper etc to a blind person. To achieve that, a Raspberry pi board, a light sensor, OpenCV computer vision library, Tesseract OCR (Optical Character Recognition library, eSpeak Text-to-Speech Synthesizer (TTS library are integrated, which is enables the blind person to hear a narration from text on a book, magazine, a sheet etc.

  7. Hematological clozapine monitoring with a point-of-care device: A randomized cross-over trial

    DEFF Research Database (Denmark)

    Nielsen, Jimmi; Thode, Dorrit; Stenager, Elsebeth

    for several reasons, perhaps most importantly because of the mandatory hematological monitoring. The Chempaq Express Blood Counter (Chempaq XBC) is a point-of-care device providing counts of white blood cells (WBC) and granulocytes based on a capillary blood sampling. A randomized cross-over trial design...

  8. 360° Operative Videos: A Randomised Cross-Over Study Evaluating Attentiveness and Information Retention.

    Science.gov (United States)

    Harrington, Cuan M; Kavanagh, Dara O; Wright Ballester, Gemma; Wright Ballester, Athena; Dicker, Patrick; Traynor, Oscar; Hill, Arnold; Tierney, Sean

    2017-11-06

    Although two-dimensional (2D) and three-dimensional videos have traditionally provided foundations for reviewing operative procedures, the recent 360º format may provide new dimensions to surgical education. This study sought to describe the production of a high quality 360º video for an index-operation (augmented with educational material), while evaluating for variances in attentiveness, information retention, and appraisal compared to 2D. A 6-camera synchronised array (GoPro Omni, [California, United States]) was suspended inverted and recorded an elective laparoscopic cholecystectomy in 2016. A single-blinded randomised cross-over study was performed to evaluate this video in 360º vs 2D formats. Group A experienced the 360º video using Samsung (Suwon, South-Korea) GearVR virtual-reality headsets, followed by the 2D experience on a 75-inch television. Group B were reversed. Each video was probed at designated time points for engagement levels and task-unrelated images or thoughts. Alternating question banks were administered following each video experience. Feedback was obtained via a short survey at study completion. The New Academic and Education Building (NAEB) in Dublin, Royal College of Surgeons in Ireland, July 2017. Preclinical undergraduate students from a medical university in Ireland. Forty students participated with a mean age of 23.2 ± 4.5 years and equal sex involvement. The 360º video demonstrated significantly higher engagement (p learning platform of choice. Mean appraisal levels for the 360º platform were positive with mean responses of >8/10 for the platform for learning, immersion, and entertainment. This study describes the successful development and evaluation of a 360º operative video. This new video format demonstrated significant engagement and attentiveness benefits compared to traditional 2D formats. This requires further evaluation in the field of technology enhanced learning. Copyright © 2017 Association of Program Directors

  9. DESIGN AND DEVELOPMENT OF A MOBILE SENSOR BASED THE BLIND ASSISTANCE WAYFINDING SYSTEM

    Directory of Open Access Journals (Sweden)

    F. Barati

    2015-12-01

    Full Text Available The blind and visually impaired people are facing a number of challenges in their daily life. One of the major challenges is finding their way both indoor and outdoor. For this reason, routing and navigation independently, especially in urban areas are important for the blind. Most of the blind undertake route finding and navigation with the help of a guide. In addition, other tools such as a cane, guide dog or electronic aids are used by the blind. However, in some cases these aids are not efficient enough in a wayfinding around obstacles and dangerous areas for the blind. As a result, the need to develop effective methods as decision support using a non-visual media is leading to improve quality of life for the blind through their increased mobility and independence. In this study, we designed and implemented an outdoor mobile sensor-based wayfinding system for the blind. The objectives of this study are to guide the blind for the obstacle recognition and the design and implementation of a wayfinding and navigation mobile sensor system for them. In this study an ultrasonic sensor is used to detect obstacles and GPS is employed for positioning and navigation in the wayfinding. This type of ultrasonic sensor measures the interval between sending waves and receiving the echo signals with respect to the speed of sound in the environment to estimate the distance to the obstacles. In this study the coordinates and characteristics of all the obstacles in the study area are already stored in a GIS database. All of these obstacles were labeled on the map. The ultrasonic sensor designed and constructed in this study has the ability to detect the obstacles in a distance of 2cm to 400cm. The implementation and the results obtained from the interview of a number of blind persons who employed the sensor verified that the designed mobile sensor system for wayfinding was very satisfactory.

  10. Design and Development of a Mobile Sensor Based the Blind Assistance Wayfinding System

    Science.gov (United States)

    Barati, F.; Delavar, M. R.

    2015-12-01

    The blind and visually impaired people are facing a number of challenges in their daily life. One of the major challenges is finding their way both indoor and outdoor. For this reason, routing and navigation independently, especially in urban areas are important for the blind. Most of the blind undertake route finding and navigation with the help of a guide. In addition, other tools such as a cane, guide dog or electronic aids are used by the blind. However, in some cases these aids are not efficient enough in a wayfinding around obstacles and dangerous areas for the blind. As a result, the need to develop effective methods as decision support using a non-visual media is leading to improve quality of life for the blind through their increased mobility and independence. In this study, we designed and implemented an outdoor mobile sensor-based wayfinding system for the blind. The objectives of this study are to guide the blind for the obstacle recognition and the design and implementation of a wayfinding and navigation mobile sensor system for them. In this study an ultrasonic sensor is used to detect obstacles and GPS is employed for positioning and navigation in the wayfinding. This type of ultrasonic sensor measures the interval between sending waves and receiving the echo signals with respect to the speed of sound in the environment to estimate the distance to the obstacles. In this study the coordinates and characteristics of all the obstacles in the study area are already stored in a GIS database. All of these obstacles were labeled on the map. The ultrasonic sensor designed and constructed in this study has the ability to detect the obstacles in a distance of 2cm to 400cm. The implementation and the results obtained from the interview of a number of blind persons who employed the sensor verified that the designed mobile sensor system for wayfinding was very satisfactory.

  11. The potential for improvement of outcomes by personalized insulin treatment of type 1 diabetes as assessed by analysis of single-patient data from a randomized controlled cross-over insulin trial

    DEFF Research Database (Denmark)

    Pedersen-Bjergaard, Ulrik; Kristensen, Peter L.; Beck-Nielsen, Henning

    2017-01-01

    1 diabetes and recurrent severe hypoglycemia were treated with basal-bolus therapy based on analog (detemir/aspart) or human (NPH/regular) insulin aiming at maintenance of baseline HbA1c levels. For each patient a superior outcome was defined as fewer events of severe hypoglycemia defined by need......Aims The evidence for optimal insulin treatment in type 1 diabetes is mainly based on randomised controlled trials applying a parallel-group design. Such trials yield robust general results but crucial individual treatment effects cannot be extracted. We aimed to assess the potential for further...... improvement of outcomes by personalized insulin therapy by analyzing data from a cross-over trial at individual level. Methods Post hoc analysis of data from a two-year multicentre, prospective, randomised, open, blinded endpoint (PROBE) trial (the HypoAna trial). In a cross-over design 114 patients with type...

  12. Dialysis-associated hypertension treated with Telmisartan--DiaTel: a pilot, placebo-controlled, cross-over, randomized trial.

    Directory of Open Access Journals (Sweden)

    Matthias Huber

    Full Text Available Treatment of hypertension in hemodialysis (HD patients is characterised by lack of evidence for both the blood pressure (BP target goal and the recommended drug class to use. Telmisartan, an Angiotensin receptor blocker (ARB that is metabolised in the liver and not excreted via HD extracorporeal circuit might be particularly suitable for HD patients. We designed and conducted a randomised, placebo-controlled, double-blind and cross-over trial for treatment of dialysis-associated hypertension with telmisartan 80 mg once daily or placebo on top of standard antihypertensive treatment excluding other Renin-Angiotensin-System (RAS blockers. In 29 patients after randomization we analysed BP after a treatment period of 8 weeks, while 13 started with telmisartan and 16 with placebo; after 8 weeks 11 continued with telmisartan and 12 with placebo after cross-over, respectively. Patients exhibited a significant reduction of systolic pre-HD BP from 141.9±21.8 before to 131.3±17.3 mmHg after the first treatment period with telmisartan or placebo. However, no average significant influence of telmisartan was observed compared to placebo. The latter may be due to a large inter-individual variability of BP responses reaching from a 40 mmHg decrease under placebo to 40 mmHg increase under telmisartan. Antihypertensive co-medication was changed for clinical reasons in 7 out of 21 patients with no significant difference between telmisartan and placebo groups. Our starting hypothesis, that telmisartan on top of standard therapy lowers systolic office BP in HD patients could not be confirmed. In conclusion, this small trial indicates that testing antihypertensive drug efficacy in HD patients is challenging due to complicated standardization of concomitant medication and other confounding factors, e.g. volume status, salt load and neurohormonal activation, that influence BP control in HD patients.Clinicaltrialsregister.eu 2005-005021-60.

  13. SMART STICK DESIGN WITH OBSTACLE DETECTION AND NAVIGATION AS THE HELPING TOOL FOR BLIND PEOPLE

    OpenAIRE

    Sumar Hadi*, Susilo Adi Widyanto, Paryanto, Kurnia Chamid, Rachmat Muhamad Andika

    2018-01-01

    Smart stick designed for the blind people, this appliance can help detect obstacles with the use of infrared sensor, ultrasonic and water. The obstacles in a distance of about 3 m can be detected assistance from this sensor. In addition, we use GPS (Global Positioning System) to give the position and navigation on the stick. Using GPS (Global Positioning System) help the blind people reaches its destination. GPS (Global Positioning System) recipients to get the location of the latest and the ...

  14. Zero cross over timing with coaxial Ge(Li) detectors

    International Nuclear Information System (INIS)

    El-Ibiary, M.Y.

    1979-07-01

    The performance of zero cross over timing systems of the constant fraction or amplitude rise time compensated type using coaxial Ge(Li) detectors is analyzed with special attention to conditions that compromise their energy-independence advantage. The outcome is verified against existing experimental results, and the parameters that lead to minimum disperson, as well as the value of the dispersion to be expected, are given by a series of charts

  15. STANFORD-OHWAKI-KOHS TACTILE BLOCK DESIGN INTELLIGENCE TEST FOR THE BLIND. PART ONE-FINAL REPORT.

    Science.gov (United States)

    DAUTERMAN, WILLIAM L.; SUINN, RICHARD M.

    THIS TEST WAS DEVELOPED TO MEASURE THE INTELLIGENCE OF BLIND ADOLESCENTS AND ADULTS. SIX HUNDRED AND THIRTY BLIND SUBJECTS 14 YEARS OF AGE AND OLDER WERE USED IN REFINING AND STANDARDIZING THE NONVERBAL, PERFORMANCE OHWAKI-KOHS BLOCK DESIGN TEST FOR USE BY BLIND INDIVIDUALS IN THE UNITED STATES. RESULTS INDICATED STATISTICALLY SIGNIFICANT…

  16. Does the placebo effect modulate drug bioavailability? Randomized cross-over studies of three drugs.

    Science.gov (United States)

    Hammami, Muhammad M; Yusuf, Ahmed; Shire, Faduma S; Hussein, Rajaa; Al-Swayeh, Reem

    2017-05-23

    Medication effect is the sum of its drug, placebo, and drug*placebo interaction effects. It is conceivable that the interaction effect involves modulating drug bioavailability; it was previously observed that being aware of caffeine ingestion may prolong caffeine plasma half-life. This study was set to evaluate such concept using different drugs. Balanced single-dose, two-period, two-group, cross-over design was used to compare the pharmacokinetics of oral cephalexin, ibuprofen, and paracetamol, each described by its name (overt) or as placebo (covert). Volunteers and study coordinators were deceived as to study aim. Drug concentrations were determined blindly by in-house, high performance liquid chromatography assays. Terminal-elimination half-life (t ½ ) (primary outcome), maximum concentration (C max ), C max first time (T max ), terminal-elimination-rate constant (λ), area-under-the-concentration-time-curve, to last measured concentration (AUC T ), extrapolated to infinity (AUC I ), or to T max of overt drug (AUC Overttmax ), and C max /AUC I were calculated blindly using standard non-compartmental method. Covert-vs-overt effect on drug pharmacokinetics was evaluated by analysis-of-variance (ANOVA, primary analysis), 90% confidence interval (CI) using the 80.00-125.00% bioequivalence range, and percentage of individual pharmacokinetic covert/overt ratios that are outside the +25% range. Fifty, 30, and 50 healthy volunteers (18%, 10%, and 6% females, mean (SD) age 30.8 (6.2), 31.4 (6.6), and 31.2 (5.4) years) participated in 3 studies on cephalexin, ibuprofen, and paracetamol, respectively. Withdrawal rate was 4%, 0%, and 4%, respectively. Eighteen blood samples were obtained over 6, 10, and 14 h in each study period of the three drugs, respectively. ANOVA showed no significant difference in any pharmacokinetic parameter for any of the drugs. The 90% CIs for AUC T , AUC I , C max , AUC Overttmax , and C max /AUC I were within the bioequivalence range, except

  17. Effect of knee joint icing on knee extension strength and knee pain early after total knee arthroplasty: a randomized cross-over study

    DEFF Research Database (Denmark)

    Holm, Bente; Husted, Henrik; Kehlet, Henrik

    2012-01-01

    Objective: To investigate the acute effect of knee joint icing on knee extension strength and knee pain in patients shortly after total knee arthroplasty.Design: A prospective, single-blinded, randomized, cross-over study.Setting: A fast-track orthopaedic arthroplasty unit at a university hospital...... in knee pain at rest (P = 0.475), or knee pain during the knee extension strength measurements (P = 0.422) were not different between treatments.Conclusions: In contrast to observations in experimental knee effusion models and inflamed knee joints, knee joint icing for 30 minutes shortly after total knee.......Participants: Twenty patients (mean age 66 years; 10 women) scheduled for primary unilateral total knee arthroplasty.Interventions: The patients were treated on two days (day 7 and day 10) postoperatively. On one day they received 30 minutes of knee icing (active treatment) and on the other day they received 30...

  18. Using acupressure and Montessori-based activities to decrease agitation for residents with dementia: a cross-over trial.

    Science.gov (United States)

    Lin, Li-Chan; Yang, Man-Hua; Kao, Chieh-Chun; Wu, Shiao-Chi; Tang, Sai-Hung; Lin, Jaung-Geng

    2009-06-01

    To explore the effectiveness of acupressure and Montessori-based activities in decreasing the agitated behaviors of residents with dementia. A double-blinded, randomized (two treatments and one control; three time periods) cross-over design was used. Six special care units for residents with dementia in long-term care facilities in Taiwan were the sites for the study. One hundred thirty-three institutionalized residents with dementia. Subjects were randomized into three treatment sequences: acupressure-presence-Montessori methods, Montessori methods-acupressure-presence and presence-Montessori methods-acupressure. All treatments were done once a day, 6 days per week, for a 4-week period. The Cohen-Mansfield Agitation Inventory, Ease-of-Care, and the Apparent Affect Rating Scale. After receiving the intervention, the acupressure and Montessori-based-activities groups saw a significant decrease in agitated behaviors, aggressive behaviors, and physically nonaggressive behaviors than the presence group. Additionally, the ease-of-care ratings for the acupressure and Montessori-based-activities groups were significantly better than for the presence group. In terms of apparent affect, positive affect in the Montessori-based-activities group was significantly better than in the presence group. This study confirms that a blending of traditional Chinese medicine and a Western activities program would be useful in elderly care and that in-service training for formal caregivers in the use of these interventions would be beneficial for patients

  19. SPECIFIC AND CROSS-OVER EFFECTS OF FOAM ROLLING ON ANKLE DORSIFLEXION RANGE OF MOTION

    Science.gov (United States)

    Beardsley, Chris

    2016-01-01

    ABSTRACT Background Flexibility is an important physical quality. Self-myofascial release (SMFR) methods such as foam rolling (FR) increase flexibility acutely but how long such increases in range of motion (ROM) last is unclear. Static stretching (SS) also increases flexibility acutely and produces a cross-over effect to contralateral limbs. FR may also produce a cross-over effect to contralateral limbs but this has not yet been identified. Purpose To explore the potential cross-over effect of SMFR by investigating the effects of a FR treatment on the ipsilateral limb of 3 bouts of 30 seconds on changes in ipsilateral and contralateral ankle DF ROM and to assess the time-course of those effects up to 20 minutes post-treatment. Methods A within- and between-subject design was carried out in a convenience sample of 26 subjects, allocated into FR (n=13) and control (CON, n=13) groups. Ankle DF ROM was recorded at baseline with the in-line weight-bearing lunge test for both ipsilateral and contralateral legs and at 0, 5, 10, 15, 20 minutes following either a two-minute seated rest (CON) or 3 3 30 seconds of FR of the plantar flexors of the dominant leg (FR). Repeated measures ANOVA was used to examine differences in ankle DF ROM. Results No significant between-group effect was seen following the intervention. However, a significant within-group effect (pin the FR group was seen between baseline and all post-treatment time-points (0, 5, 10, 15 and 20 minutes). Significant within-group effects (pin the ipsilateral leg between baseline and at all post-treatment time-points, and in the contralateral leg up to 10 minutes post-treatment, indicating the presence of a cross-over effect. Conclusions FR improves ankle DF ROM for at least 20 minutes in the ipsilateral limb and up to 10 minutes in the contralateral limb, indicating that FR produces a cross-over effect into the contralateral limb. The mechanism producing these cross-over effects is unclear but may involve

  20. Some considerations in the design of a Venetian Blind direct converter

    International Nuclear Information System (INIS)

    Barr, W.L.

    1975-01-01

    The structural design of a Venetian Blind direct converter will depend on the choice, for example, of: 1) Expander field, (2) Selective leakage, (3) Number of collector stages, (4) Method of cooling and (5) The general configuration and orientation. This note is intended to outline the major compromises that will result from the variation of parameters to fit a particular design. The relationships given are for a two-stage unit, but it is straightforward to extend them to multiple-stage units

  1. Ploidy, sex and crossing over in an evolutionary aging model

    Science.gov (United States)

    Lobo, Matheus P.; Onody, Roberto N.

    2006-02-01

    Nowadays, many forms of reproduction coexist in nature: Asexual, sexual, apomictic and meiotic parthenogenesis, hermaphroditism and parasex. The mechanisms of their evolution and what made them successful reproductive alternatives are very challenging and debated questions. Here, using a simple evolutionary aging model, we give a possible scenario. By studying the performance of populations where individuals may have diverse characteristics-different ploidies, sex with or without crossing over, as well as the absence of sex-we find an evolution sequence that may explain why there are actually two major or leading groups: Sexual and asexual. We also investigate the dependence of these characteristics on different conditions of fertility and deleterious mutations. Finally, if the primeval organisms on Earth were, in fact, asexual individuals we conjecture that the sexual form of reproduction could have more easily been set and found its niche during a period of low-intensity mutations.

  2. Blind Astronomers

    Science.gov (United States)

    Hockey, Thomas A.

    2011-01-01

    The phrase "blind astronomer” is used as an allegorical oxymoron. However, there were and are blind astronomers. What of famous blind astronomers? First, it must be stated that these astronomers were not martyrs to their craft. It is a myth that astronomers blind themselves by observing the Sun. As early as France's William of Saint-Cloud (circa 1290) astronomers knew that staring at the Sun was ill-advised and avoided it. Galileo Galilei did not invent the astronomical telescope and then proceed to blind himself with one. Galileo observed the Sun near sunrise and sunset or through projection. More than two decades later he became blind, as many septuagenarians do, unrelated to their profession. Even Isaac Newton temporarily blinded himself, staring at the reflection of the Sun when he was a twentysomething. But permanent Sun-induced blindness? No, it did not happen. For instance, it was a stroke that left Scotland's James Gregory (1638-1675) blind. (You will remember the Gregorian telescope.) However, he died days later. Thus, blindness little interfered with his occupation. English Abbot Richard of Wallingford (circa 1291 - circa 1335) wrote astronomical works and designed astronomical instruments. He was also blind in one eye. Yet as he further suffered from leprosy, his blindness seems the lesser of Richard's maladies. Perhaps the most famous professionally active, blind astronomer (or almost blind astronomer) is Dominique-Francois Arago (1786-1853), director until his death of the powerful nineteenth-century Paris Observatory. I will share other _ some poignant _ examples such as: William Campbell, whose blindness drove him to suicide; Leonhard Euler, astronomy's Beethoven, who did nearly half of his life's work while almost totally blind; and Edwin Frost, who "observed” a total solar eclipse while completely sightless.

  3. Tranexamic acid for epistaxis in hereditary hemorrhagic telangiectasia patients: a European cross-over controlled trial in a rare disease.

    Science.gov (United States)

    Gaillard, S; Dupuis-Girod, S; Boutitie, F; Rivière, S; Morinière, S; Hatron, P-Y; Manfredi, G; Kaminsky, P; Capitaine, A-L; Roy, P; Gueyffier, F; Plauchu, H

    2014-09-01

    Hereditary hemorrhagic telangiectasia (HHT) is a genetic disorder associated with abnormal angiogenesis and disabling epistaxis. Tranexamic acid (TA) has been widely used in the treatment of these severe bleeds but with no properly designed trial. To demonstrate the efficacy of TA in epistaxis in HHT patients and to explore its safety of use. A randomized, placebo-controlled, double-blind, cross-over trial was conducted. Participants were randomized to receive TA (3 g a day) then placebo or the opposite sequence. The main analysis compared intra-individual mean duration of epistaxis under TA vs. placebo on a log scale. The primary outcome was the mean duration of epistaxis per month, assessed with specific grids to be completed by participants. The number of epistaxis episodes was recorded as a secondary outcome. A total of 118 randomized patients contributed to the statistical analysis. The mean duration of epistaxis per month was significantly shorter with TA than placebo (0.19 on the log scale; SD = 0.07; P = 0.005), corresponding to a decrease of 17.3% (15.7 min) in the duration of epistaxis per month (CI 95%, 5.5-27.6). The median number of epistaxis episodes per month was 22.1 episodes in the placebo arm vs. 23.3 episodes in the TA arm. No thrombophlebitis was observed. In the ATERO study, we demonstrated a significant decrease in the duration of epistaxis in HHT patients taking TA. No safety issues were recorded in our cohort of patients. © 2014 International Society on Thrombosis and Haemostasis.

  4. DMFC performance and methanol cross-over: Experimental analysis and model validation

    Science.gov (United States)

    Casalegno, A.; Marchesi, R.

    A combined experimental and modelling approach is proposed to analyze methanol cross-over and its effect on DMFC performance. The experimental analysis is performed in order to allow an accurate investigation of methanol cross-over influence on DMFC performance, hence measurements were characterized in terms of uncertainty and reproducibility. The findings suggest that methanol cross-over is mainly determined by diffusion transport and affects cell performance partly via methanol electro-oxidation at the cathode. The modelling analysis is carried out to further investigate methanol cross-over phenomenon. A simple model evaluates the effectiveness of two proposed interpretations regarding methanol cross-over and its effects. The model is validated using the experimental data gathered. Both the experimental analysis and the proposed and validated model allow a substantial step forward in the understanding of the main phenomena associated with methanol cross-over. The findings confirm the possibility to reduce methanol cross-over by optimizing anode feeding.

  5. Comparison between self-formulation and compounded-formulation dexamethasone mouth rinse for oral lichen planus: a pilot, randomized, cross-over trial.

    Science.gov (United States)

    Hambly, Jessica L; Haywood, Alison; Hattingh, Laetitia; Nair, Raj G

    2017-08-01

    There is a lack of appropriate, commercially-available topical corticosteroid formulations for use in oral lichen planus (OLP) and oral lichenoid reaction. Current therapy includes crushing a dexamethasone tablet and mixing it with water for use as a mouth rinse. This formulation is unpleasant esthetically and to use in the mouth, as it is a bitter and gritty suspension, resulting in poor compliance. Thus, the present study was designed to formulate and pilot an effective, esthetically-pleasing formulation. A single-blinded, cross-over trial was designed with two treatment arms. Patients were monitored for 7 weeks. Quantitative and qualitative data was assessed using VAS, numeric pain scales, the Treatment Satisfaction Questionnaire for Medication-9, and thematic analysis to determine primary patient-reported outcomes, including satisfaction, compliance, quality of life, and symptom relief. Nine patients completed the pilot trial. Data analysis revealed the new compounded formulation to be superior to existing therapy due to its convenience, positive contribution to compliance, patient-perceived faster onset of action, and improved symptom relief. Topical dexamethasone is useful in the treatment of OLP. When carefully formulated into a compounded mouth rinse, it improves patient outcomes. © 2016 John Wiley & Sons Australia, Ltd.

  6. Blinded sample size re-estimation in three-arm trials with 'gold standard' design.

    Science.gov (United States)

    Mütze, Tobias; Friede, Tim

    2017-10-15

    In this article, we study blinded sample size re-estimation in the 'gold standard' design with internal pilot study for normally distributed outcomes. The 'gold standard' design is a three-arm clinical trial design that includes an active and a placebo control in addition to an experimental treatment. We focus on the absolute margin approach to hypothesis testing in three-arm trials at which the non-inferiority of the experimental treatment and the assay sensitivity are assessed by pairwise comparisons. We compare several blinded sample size re-estimation procedures in a simulation study assessing operating characteristics including power and type I error. We find that sample size re-estimation based on the popular one-sample variance estimator results in overpowered trials. Moreover, sample size re-estimation based on unbiased variance estimators such as the Xing-Ganju variance estimator results in underpowered trials, as it is expected because an overestimation of the variance and thus the sample size is in general required for the re-estimation procedure to eventually meet the target power. To overcome this problem, we propose an inflation factor for the sample size re-estimation with the Xing-Ganju variance estimator and show that this approach results in adequately powered trials. Because of favorable features of the Xing-Ganju variance estimator such as unbiasedness and a distribution independent of the group means, the inflation factor does not depend on the nuisance parameter and, therefore, can be calculated prior to a trial. Moreover, we prove that the sample size re-estimation based on the Xing-Ganju variance estimator does not bias the effect estimate. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  7. Cardiovascular Effects of Energy Drinks in Familial Long QT Syndrome: A Randomized Cross-Over Study.

    Science.gov (United States)

    Gray, Belinda; Ingles, Jodie; Medi, Caroline; Driscoll, Timothy; Semsarian, Christopher

    2017-03-15

    Caffeinated energy drinks may trigger serious cardiac effects. The aim of this study was to determine the cardiovascular effects of caffeinated energy drink consumption in patients with familial long QT syndrome (LQTS). From 2014-2016, 24 LQTS patients aged 16-50 years were recruited to a randomized, double-blind, cross-over study of energy drink (ED) versus control (CD) with participants acting as their own controls (one week washout). The primary study outcome was an increase in corrected QT interval (QTc) by >20ms. Secondary outcomes were changes in systolic and diastolic blood pressure. In 24 patients with LQTS (no dropout), mean age was 29±9 years, 13/24 (54%) were female, and 8/24 (33%) were probands. Intention to treat analysis revealed no significant change in QTc with ED compared with CD (12±28ms vs 16±27ms, 3% vs 4%, p=0.71). The systolic and diastolic blood pressure significantly increased with ED compared to CD (peak change 7±16mmHg vs 1±16mmHg, 6% vs 0.8%, p=0.046 and 8±10 vs 2±9mmHg, 11% vs 3% p=0.01 respectively). These changes correlated with significant increases in serum caffeine (14.6±11.3 vs 0.5±0.1μmol/L, penergy drink consumption. Caffeinated energy drinks have significant haemodynamic effects in patients with LQTS, especifically an acute increase in blood pressure. Since dangerous QTc prolongation was seen in some LQTS patients, we recommend caution in young patients with LQTS consuming energy drinks. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  8. Antibiotics in periodontal surgeries: A prospective randomised cross over clinical trial

    Directory of Open Access Journals (Sweden)

    Sheetal Oswal

    2014-01-01

    Full Text Available Aims and Objectives: (1 To evaluate the need of antibiotics in periodontal surgeries in reducing postsurgical infections and explore if antibiotics have any key role in reducing or eliminating inflammatory complications. (2 To establish the incidence of postoperative infections in relation to type of surgery and determine those factors, which may affect infection rates. Materials and Methods: A prospective randomized double-blind cross over clinical study was carried out for a period of 1-year with predefined inclusion and exclusion criteria. All the patients included in the study for any periodontal surgery were randomly divided into three categories: Group A (prophylactic, Group B (therapeutic, and Group C (no antibiotics. Patients were followed up for 1-week after surgery on the day of suture removal and were evaluated for pain, swelling, fever, infection, delayed wound healing and any other significant findings. Appropriate statistical analysis was carried out to evaluate the objectives and P < 0.05 was considered as statistically significant. Results: No infection was reported in any of 90 sites. Patients reported less pain and postoperative discomfort when prophylactic antibiotics were given. However, there were no statistical significant differences between the three groups. Summary and Conclusion: There was no postoperative infection reported in all the 90 sites operated in this study. The prevalence of postoperative infections following periodontal surgery is <1% and this low risk does not justify the routine use of systemic antimicrobials just to prevent infections. Use of prophylactic antibiotics may have role in prevention of inflammatory complication, but again not infection.

  9. Comparison of transcutaneous electrical nerve stimulation (TENS) and functional electrical stimulation (FES) for spasticity in spinal cord injury - A pilot randomized cross-over trial.

    Science.gov (United States)

    Sivaramakrishnan, Anjali; Solomon, John M; Manikandan, Natarajan

    2017-10-25

    Spasticity following spinal cord injury (SCI) can impair function and affect quality of life. This study compared the effects of transcutaneous electrical nerve stimulation (TENS) and functional electrical stimulation (FES) on lower limb spasticity in patients with SCI. Double blind randomized crossover design. Neuro-rehabilitation unit, Manipal University, India. Ten participants (age: 39 ± 13.6 years, C1-T11, 1-26 months post SCI) with lower limb spasticity were enrolled in this study. Participants were administered electrical stimulation with TENS and FES (duration - 30 minutes) in a cross over manner separated by 24 hours. Spasticity was measured using modified Ashworth scale (MAS) [for hip abductors, knee extensors and ankle plantar flexors] and spinal cord assessment tool for spastic reflexes (SCATS). Assessments were performed at baseline, immediately, 1 hour, 4 hours, and 24 hours post intervention. A between group analysis did not show statistically significant differences between FES and TENS (P > 0.05). In the within group analyses, TENS and FES significantly reduced spasticity up to 4 hours in hip adductors and knee extensors (P electrical stimulation with FES and TENS appears to have similar anti-spasticity effects that last for 4 hours. The findings of this preliminary study suggest that both TENS and FES have the potential to be used as therapeutic adjuncts to relieve spasticity in the clinic. In addition, FES may have better effects on patients presenting with spastic reflexes.

  10. Effect of eicosapentaenoic and docosahexaenoic acid on resting and exercise-induced inflammatory and oxidative stress biomarkers: a randomized, placebo controlled, cross-over study

    Directory of Open Access Journals (Sweden)

    Galpin Andrew J

    2009-08-01

    Full Text Available Abstract Background The purpose of the present investigation was to determine the effects of EPA/DHA supplementation on resting and exercise-induced inflammation and oxidative stress in exercise-trained men. Fourteen men supplemented with 2224 mg EPA+2208 mg DHA and a placebo for 6 weeks in a random order, double blind cross-over design (with an 8 week washout prior to performing a 60 minute treadmill climb using a weighted pack. Blood was collected pre and post exercise and analyzed for a variety of oxidative stress and inflammatory biomarkers. Blood lactate, muscle soreness, and creatine kinase activity were also measured. Results Treatment with EPA/DHA resulted in a significant increase in blood levels of both EPA (18 ± 2 μmol·L-1 vs. 143 ± 23 μmol·L-1; p -1 vs. 157 ± 13 μmol·L-1; p 0.05. There was a mild increase in oxidative stress in response to exercise (XO and H2O2 (p Conclusion EPA/DHA supplementation increases blood levels of these fatty acids and results in decreased resting levels of inflammatory biomarkers in exercise-trained men, but does not appear necessary for exercise-induced attenuation in either inflammation or oxidative stress. This may be due to the finding that trained men exhibit a minimal increase in both inflammation and oxidative stress in response to moderate duration (60 minute aerobic exercise.

  11. Extra virgin olive oil phenols and markers of oxidation in Greek smokers: a randomized cross-over study.

    Science.gov (United States)

    Moschandreas, J; Vissers, M N; Wiseman, S; van Putte, K P; Kafatos, A

    2002-10-01

    To examine the effect of a low phenol olive oil and high phenol olive oil on markers of oxidation and plasma susceptibility to oxidation in normolipaemic smokers. Randomized single-blind cross-over trial with two intervention periods. The Medical School and University Hospital of the University of Crete, Heraklion, Crete, Greece. Twenty-five healthy males and females completed the study. Each intervention was of three weeks duration and intervention periods were separated by a two week washout. Seventy grams of extra virgin olive oil was supplied to each subject per day in the intervention periods. The olive oils supplied differed in their phenol content by 18.6 mg/day. Two fasting venous blood samples were taken at the end of each intervention period. The markers of antioxidant capacity measured in fasting plasma samples (total plasma resistance to oxidation, concentrations of protein carbonyl as a marker of protein oxidation, malondialdehyde and lipid hydroperoxides as markers of lipid oxidation and the ferric reducing ability of plasma) did not differ significantly between the low and high phenol olive oil diets. No effect of olive oil phenols on markers of oxidation in smokers was detected. It may be that the natural concentrations of phenols in olive oil are too low to produce an effect in the post-absorptive phase. Possible reasons for period effects and interactions between diet and administration period need attention to aid further cross-over trials of this kind. Unilever Research Vlaardingen, The Netherlands.

  12. Correlation of the cross-over ratio of the cross-over sign on conventional pelvic radiographs with computed tomography retroversion measurements

    International Nuclear Information System (INIS)

    Werner, Clement M.L.; Copeland, Carol E.; Stromberg, Jeff; Ruckstuhl, Thomas

    2010-01-01

    To find a correlation between the cross-over ratio of the cross-over sign on conventional anteroposterior (AP) pelvic radiographs and retroversion measurements ('roof-edge angle' and 'equatorial-edge angle) on computed tomography (CT) scans. This would facilitate the interpretation of the cross-over sign regarding the amount of acetabular retroversion. Correctly projected AP pelvic radiographs (2,925 hips) were examined for the presence of the cross-over sign (COS), and the overlap ratio of the COS was measured. On CT scans of the same patients the 'roof-edge angle' (RE angle) and the 'equatorial-edge angle' (EE angle) were also calculated. A statistically significant but only weak relationship could be found between the overlap ratio of the COS and the 'roof-edge angle' (P < 0.0001; correlation coefficient -0.486) and between this ratio and the 'equatorial-edge angle' (P < 0.0001; correlation coefficient -0.395). A relationship between the overlap ratio and orientation measurements on CT scans could be found, but it was less strong than expected. (orig.)

  13. Prospective, randomized, open-label, blinded-endpoint (PROBE) designed trials yield the same results as double-blind, placebo-controlled trials with respect to ABPM measurements.

    Science.gov (United States)

    Smith, David H; Neutel, Joel M; Lacourcière, Yves; Kempthorne-Rawson, Joan

    2003-07-01

    This meta-analysis aimed to determine whether ambulatory blood pressure monitoring (ABPM) results from double-blind, placebo-controlled (DBPC) and prospective, randomized, open-label, blinded-endpoint (PROBE) hypertension trials are statistically comparable. Two DBPC and three PROBE parallel-group studies were selected from an angiotensin II receptor blocker clinical programme. These were fixed-dose studies involving similar mild to moderate hypertensive patient populations. All used SpaceLabs 90207 ABPM devices, and each comprised a 4-week placebo period and a 4-8-week treatment period. Data from patients receiving telmisartan 80 mg were used to compare the results of DBPC (126 patients) and PROBE (734 patients) trials. The analysis had approximately 87% power to show equivalence between the two design types in terms of ruling out differences of >or= 3 mmHg in SBP and >or= 2 mmHg in DBP. Office blood pressure was also compared. The change from baseline in mean 24-h ambulatory SBP was -12.2 mmHg in DBPC trials and -12.3 mmHg in PROBE trials, a rounded difference of 0.2 mmHg [95% confidence interval (CI): -1.8, 2.1]. The change from baseline in mean 24-h ambulatory DBP was -7.7 mmHg in DBPC trials versus -7.9 mmHg in PROBE trials, a difference of 0.2 mmHg (95% CI: -1.1, 1.5). Ambulatory pulse pressure results were identical. Thus, changes in mean 24-h ambulatory blood pressure from the DBPC and PROBE trials in this meta-analysis are statistically equivalent in terms of ruling out a difference of >or= 3 mmHg in SBP and >or= 2 mmHg in DBP. This supports the validity of the PROBE design in assessing antihypertensive efficacy based on blinded ABPM measurements.

  14. Design challenges in a double-blinded RCT study of music therapy for people suffering from szhizophrenia with negative symptoms

    DEFF Research Database (Denmark)

    Pedersen, Inge Nygaard

    2016-01-01

    . The study includes 120 participants. Participants in the experimental group become 25 hours of individual music therapy by specific trained music therapists working from a manual, wheras the control Group become 25 hours of being together with a care persone (trained by a music therapist) for music......The aim of this study is to examine if postiive results of International Cochrane Reviews on Music Therapy and Schizophrenia can be confirmed by a randomized controlled double blinded study on music therapy for people suffering from schizophrenia with extensive negative symptoms in Denmark...... listening from a selected playlist. Ethical refelctions around the design will be presented, and the possibilities of keeping the examination process blinded or not blinded to the participants with be shared. As this examination is currently running, the focus will be on the Development of abd application...

  15. Experimental analysis of methanol cross-over in a direct methanol fuel cell

    International Nuclear Information System (INIS)

    Casalegno, Andrea; Grassini, Paolo; Marchesi, Renzo

    2007-01-01

    Methanol cross-over through the polymeric membrane is one of the main causes limiting direct methanol fuel cell performances. It causes fuel wasting and enhances cathode overpotential. A repeatable and reproducible measurement system, that assures the traceability of the measurement to international reference standards, is necessary to compare different fuel cell construction materials. In this work a method to evaluate methanol cross-over rate and operating condition influence is presented and qualified in term of measurement uncertainty. In the investigated range, the methanol cross-over rate results mainly due to diffusion through the membrane, in fact it is strongly affected by temperature. Moreover the cross-over influence on fuel utilization and fuel cell efficiency is investigated. The methanol cross-over rate appears linearly proportional to electrochemical fuel utilization and values, obtained by measurements at different anode flow rate but constant electrochemical fuel utilization, are roughly equal; methanol wasting, due to cross-over, is considerable and can still be higher than electrochemical utilization. The fuel recirculation effect on energy efficiency has been investigated and it was found that fuel recirculation gives more advantage at low temperature, but fuel cell energy efficiency results are in any event higher at high temperature

  16. A randomised cross-over pharmacokinetic bioavailability study of synthetic versus kiwifruit-derived vitamin C.

    Science.gov (United States)

    Carr, Anitra C; Bozonet, Stephanie M; Vissers, Margreet C M

    2013-11-11

    Kiwifruit are a rich source of vitamin C and also contain numerous phytochemicals, such as flavonoids, which may influence the bioavailability of kiwifruit-derived vitamin C. The aim of this study was to compare the relative bioavailability of synthetic versus kiwifruit-derived vitamin C using a randomised cross-over pharmacokinetic study design. Nine non-smoking males (aged 18-35 years) received either a chewable tablet (200 mg vitamin C) or the equivalent dose from gold kiwifruit (Actinidia chinensis var. Sungold). Fasting blood and urine were collected half hourly to hourly over the eight hours following intervention. The ascorbate content of the plasma and urine was determined using HPLC with electrochemical detection. Plasma ascorbate levels increased from 0.5 h after the intervention (P = 0.008). No significant differences in the plasma time-concentration curves were observed between the two interventions (P = 0.645). An estimate of the total increase in plasma ascorbate indicated complete uptake of the ingested vitamin C tablet and kiwifruit-derived vitamin C. There was an increase in urinary ascorbate excretion, relative to urinary creatinine, from two hours post intervention (P vitamin C tablet and kiwifruit arms, respectively. Overall, our pharmacokinetic study has shown comparable relative bioavailability of kiwifruit-derived vitamin C and synthetic vitamin C.

  17. Design af lægemiddelstudier

    DEFF Research Database (Denmark)

    Christensen, Steffen; Christiansen, Christian; Sørensen, Henrik Toft

    2009-01-01

    Randomized controlled trials (RCTs) have been considered the reference standard for evaluation of drug effects. Controversy exists concerning observational studies because of the lack of blinding and the risk of uncontrolled confounding. However, RCTs also have limitations, including short follow......-up and relatively small study populations, which make it impossible to examine rare events and cross-over problems. None of the designs provides perfect information and both designs are needed in the evaluation of drug effects. Udgivelsesdato: 2009-Mar-2...

  18. Single tooth anesthesia versus conventional anesthesia: a cross-over study.

    Science.gov (United States)

    Campanella, Vincenzo; Libonati, Antonio; Nardi, Roberto; Angotti, Vincenzo; Gallusi, Gianni; Montemurro, Edoardo; D'Amario, Maurizio; Marzo, Giuseppe

    2018-03-10

    The aim of the present study was to compare an electronic device, the Wand Injection System (Milestone Scientific Livingstone), with conventional anesthesia in terms of the following: pain sensation during anesthetic injection; effectiveness in achieving adequate anesthesia for a complete painless dental treatment; post-operative discomfort; and patient's anxiety toward dental treatment. Eighty adults from 18 to 70 years were enrolled in this cross-over study. Each patient served as his/her own control being subject to two anesthesia techniques: conventional and Single Tooth Anesthesia (STA) performed with the Wand. A split-mouth design was adopted in which each tooth undergoing conservative restorative or endodontic treatment received anesthesia with both techniques at 1-week interval. Before anesthetic administration, the patients' anxiety levels were determined. Physiological parameteres were measured before, during, and after the two injection procedures, and the Visual Analogue Scale (VAS) was used to assess pain of injection, discomfort, and anesthetic efficacy. Differences in assessment of pain's injection, discomfort, anesthetic efficacy, vital parameters (heart rate, blood pressure, and oxygen saturation), and state anxiety levels were analyzed using Student's t test (p value < 0.001). The mean injection pain and post-operative discomfort ratings with Wand were lower than those with conventional syringe (p = 0.022 and p < 0.001, respectively). No differences were found in the assessment of anesthetic efficacy. Blood pressure and heart rate mean values were lower during the anesthesia performed with the Wand than with the conventional syringe (p < 0.001). The anxiety level was higher during the first appointment, independently from the device used for the injections. The STA technique resulted in lower pain, discomfort, and lower intensity of physiological parameters. Single Tooth Anesthesia could be an efficacious alternative to

  19. Cross-over study of novice intubators performing endotracheal intubation in an upright versus supine position.

    Science.gov (United States)

    Turner, Joseph S; Ellender, Timothy J; Okonkwo, Enola R; Stepsis, Tyler M; Stevens, Andrew C; Eddy, Christopher S; Sembroski, Erik G; Perkins, Anthony J; Cooper, Dylan D

    2017-06-01

    There are a number of potential physical advantages to performing orotracheal intubation in an upright position. The objective of this study was to measure the success of intubation of a simulated patient in an upright versus supine position by novice intubators after brief training. This was a cross-over design study in which learners (medical students, physician assistant students, and paramedic students) intubated mannequins in both a supine (head of the bed at 0°) and upright (head of bed elevated at 45°) position. The primary outcome of interest was successful intubation of the trachea. Secondary outcomes included log time to intubation, Cormack-Lehane view obtained, Percent of Glottic Opening score, provider assessment of difficulty, and overall provider satisfaction with the position. There were a total of 126 participants: 34 medical students, 84 physician assistant students, and 8 paramedic students. Successful tracheal intubation was achieved in 114 supine attempts (90.5 %) and 123 upright attempts (97.6 %; P = 0.283). Upright positioning was associated with significantly faster log time to intubation, higher likelihood of achieving Grade I Cormack-Lehane view, higher Percent of Glottic Opening score, lower perceived difficulty, and higher provider satisfaction. A subset of 74 participants had no previous intubation training or experience. For these providers, there was a non-significant trend toward improved intubation success with upright positioning vs supine positioning (98.6 % vs. 87.8 %, P = 0.283). For all secondary outcomes in this group, upright positioning significantly outperformed supine positioning.

  20. Area-specific modulation of neural activation comparing escitalopram and citalopram revealed by pharmaco-fMRI: a randomized cross-over study.

    Science.gov (United States)

    Windischberger, Christian; Lanzenberger, Rupert; Holik, Alexander; Spindelegger, Christoph; Stein, Patrycja; Moser, Ulrike; Gerstl, Florian; Fink, Martin; Moser, Ewald; Kasper, Siegfried

    2010-01-15

    Area-specific and stimulation-dependent changes of human brain activation by selective serotonin reuptake inhibitors (SSRI) are an important issue for improved understanding of treatment mechanisms, given the frequent prescription of these drugs in depression and anxiety disorders. The aim of this neuroimaging study was to investigate differences in BOLD-signal caused by administration of the SSRIs escitalopram and citalopram using pharmacological functional magnetic resonance imaging (pharmaco-fMRI). Eighteen healthy subjects participated in a placebo-controlled, randomized, double-blind study in cross-over repeated measures design. Each volunteer performed facial emotional discrimination and a sensorimotor control paradigm during three scanning sessions. Citalopram (20 mg/d), escitalopram (10 mg/d) and placebo were administered for 10 days each with a drug-free period of at least 21 days. Significant pharmacological effects on BOLD-signal were found in the amygdala, medial frontal gyrus, parahippocampal, fusiform and middle temporal gyri. Post-hoc t-tests revealed decreased BOLD-signal in the right amygdala and left parahippocampal gyrus in both pharmacological conditions, compared to placebo. Escitalopram, compared to citalopram, induced a decrease of BOLD-signal in the medial frontal gyrus and an increase in the right fusiform and left parahippocampal gyri. Drug effects were concentrated in brain regions with dense serotonergic projections. Both escitalopram and citalopram attenuated BOLD-signal in the amygdala and parahippocampal cortex to emotionally significant stimuli compared to control stimuli. We believe that reduced reactivity in the medial frontal gyrus found for escitalopram compared to citalopram administration might explain the response differences between study drugs as demonstrated in previous clinical trials.

  1. Prevention of alcohol-induced DNA damage by a proprietary glycyrrhizin/D-mannitol product: A randomized, placebo-controlled, cross-over human study.

    Science.gov (United States)

    Chigurupati, Harsha; Auddy, Biswajit; Biyani, Manish; Chakrabarti, Shrabana; Stohs, Sidney J

    2017-11-06

    The purpose of the present study was to evaluate the ability of a proprietary combination of glycyrrhizin and D-mannitol to protect against oxidative damage to DNA associated with acute alcohol consumption by human subjects in a randomized, placebo-controlled cross-over designed study. Excessive alcohol consumption is associated with numerous diseases. Alcohol has been shown to generate reactive oxygen species that can result in DNA damage, leading to genetic and epigenetic changes. A total of 25 subjects (13 male and 12 female) were enrolled. Alcohol intake in the form of vodka (40% ethanol) was adjusted based on 1.275 g of 100% ethanol/kg body weight for men and 1.020 g/kg body weight for women, which was consumed with and without the study product. Blood samples were drawn at 2 h after alcohol consumption, lymphocytes were isolated, and were subjected to DNA comet electrophoresis on a blinded basis. Acute alcohol consumption increased lymphocyte DNA damage by approximately 8.36%. Co-consumption of the glycyrrhizin/D-mannitol study product with alcohol reduced DNA damage to baseline levels. No adverse effects were associated with use of the study product, and no differences were observed in blood alcohol concentrations in the presence or absence of the study product in males and females. Acute alcohol ingestion resulted in measurable increases in DNA damage, which were prevented by the addition of the proprietary glycyrrhizin/D-mannitol (NTX ® ) study product to the alcohol, suggesting that the tissue-damaging effects of alcohol consumption can be ameliorated. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. A cross-over from Sport Psychology to the Psychology of Music: An ...

    African Journals Online (AJOL)

    The primary aim of this research was to evaluate whether the cross-over from Sport Psychology to the Psychology of Music in terms of the knowledge base, intervention Psychological Skills Training (PST) protocols and psychometric measurements was meaningful. A second aim was to ascertain whether the psychological ...

  3. On the dynamical mechanism of cross-over from chaotic to turbulent ...

    Indian Academy of Sciences (India)

    the study of experimental time series reports an intriguing cross-over phenomenon from a low dimensional ... While there is consid- erable theoretical work to understand this complex collective phenomenon [7], the ..... cations edited by F R N Nabarro and M S Deusbery (North-Holland, Amsterdam,. 2002) vol. 11, p. 101.

  4. Feasibility of a Web-Based Cross-Over Paleolithic Diet Intervention in the General Population

    NARCIS (Netherlands)

    Nederhof, Esther; Bikker, Esther

    2017-01-01

    Introduction: The primary aim was to investigate feasibility of a web-based cross-over Paleolithic diet intervention in the general population. The secondary aim was to calculate the sample size needed to reach a statistically significant difference in effect of a Paleolithic-like diet on

  5. On the dynamical mechanism of cross-over from chaotic to turbulent ...

    Indian Academy of Sciences (India)

    Recent dynamical approach to the study of experimental time series reports an intriguing cross-over phenomenon from a low dimensional chaotic to an infinite dimensional scale invariant power-law regime of stress drops in experiments on CuAl single crystals and AlMg polycrystals, as a function of strain rate. We show that ...

  6. The optimal injection technique for the osteoarthritic ankle: A randomized, cross-over trial

    NARCIS (Netherlands)

    Witteveen, Angelique G. H.; Kok, Aimee; Sierevelt, Inger N.; Kerkhoffs, Gino M. M. J.; van Dijk, C. Niek

    2013-01-01

    Background: To optimize the injection technique for the osteoarthritic ankle in order to enhance the effect of intra-articular injections and minimize adverse events. Methods: Randomized cross-over trial. Comparing two injection techniques in patients with symptomatic ankle osteoarthritis. Patients

  7. Stress analysis of LOFT steam generator blowdown cross-over line

    International Nuclear Information System (INIS)

    Singh, J.N.

    1978-01-01

    The purpose of this report is to demonstrate compliance of the LOFT Steam Generator Blowdown Cross-Over Piping with the ASME Boiler and Pressure Vessel Code, Section III, Subsection NC. Deadweight, thermal expansion, seismic, LOCE, and LOCA loads have been considered. With the addition of two snubbers, as shown in this report, the system conforms to all requirements

  8. Effects of walking on bilateral differences in spatial attention control: a cross-over design.

    Science.gov (United States)

    Koyama, Soichiro; Tanabe, Shigeo; Hirakawa, Yuichi; Sakurai, Hiroaki; Kanada, Yoshikiyo

    2015-01-01

    Walking requires a high attentional cost for balance control and interferes with the control of attention. However, it is unclear whether the performance of visual spatial attention control, which is one of the functions of attention control, is also decreased during walking. In addition, although previous studies have shown right-hemispheric dominance and lower ability of left side visual spatial attention control during sitting, it remains unknown whether walking accentuates bilateral differences in visual spatial attention control. We tested the hypothesis that walking interferes with visual spatial attention control on both sides and accentuates its bilateral differences. Twenty healthy right-handed subjects (24.3 ± 2.0 years) participated in this study. Subjects performed a random stimulus-response compatibility (SRC) task during both sitting and walking situations. To evaluate the effects of walking, reaction time was measured on both sides for the two situations. In comparison to the both situations (sitting and walking), the amount of change of the SRC effect on both sides was used. In the comparing the bilateral difference (left and right), the difference of the SRC effect was evaluated in each situation. The paired t-test was applied to both comparisons for statistical analysis. The SRC effect on both sides during walking was significantly larger than during sitting ( P  < 0.05). In addition, walking significantly accentuated the bilateral differences in visual spatial attention control ( P  < 0.05). These results suggest that walking affects the performance of visual spatial attention control on both sides and accentuates its bilateral differences. These results have implications for development of practice methods of gait disorder with higher brain dysfunction.

  9. Dark chocolate and vascular function in patients with peripheral artery disease: a randomized, controlled cross-over trial.

    Science.gov (United States)

    Hammer, Alexandra; Koppensteiner, Renate; Steiner, Sabine; Niessner, Alexander; Goliasch, Georg; Gschwandtner, Michael; Hoke, Matthias

    2015-01-01

    Flavonoid-rich dark chocolate has positive effects on vascular function in healthy subjects and in patients at risk of atherosclerosis. The impact of dark chocolate on endothelial and microvascular function in patients with symptomatic peripheral artery disease (PAD) has not been investigated so far. In an investigator blinded, randomized, controlled, cross-over trial we assessed the effect of flavonoid-rich dark chocolate and cocoa-free control chocolate on flow-mediated dilatation (FMD) of the brachial artery and on microvascular function (assessed by Laser Doppler fluxmetry) in 21 patients with symptomatic (Fontaine stage II) PAD. Measurements were done in each patient on 2 single days, with an interval of 7 days, at baseline and at 2 hours after ingestion of 50 g dark chocolate or 50 g white chocolate, respectively. FMD remained unchanged after intake of dark chocolate (baseline and 2 hours after ingestion, %: 5.1 [IQR 4.4 to 7.3] and 5.5 [IQR 3.9 to 10.4]; p = 0.57, and after intake of white chocolate (baseline and 2 hours after ingestion, %: 6.4 [IQR 4.5 to 11.4] and 4.4 [IQR 2.6 to 8.7]; p = 0.14. Similarly, microcirculatory parameters were not significantly altered after intake of any chocolate compared with the respective baseline values. In conclusion, a single consumption of 50 g dark chocolate has no effect on endothelial and microvascular function in patients with symptomatic PAD.

  10. Evaluation of Valerians’ effect on sleep quantity and quality of menopausal women: cross-over clinical trial

    Directory of Open Access Journals (Sweden)

    Mandana Mirmohammadali

    2014-02-01

    Full Text Available Background: Menopause causes poor sleep quality in women, so that great throngs of menopausal women experience menopause-induced sleep disorders. This study was conducted to determine the effects of valerian extract on sleep quantity and quality of postmenopausal women. Methods: This triple-blind, randomized, cross-over clinical trial was performed on 144 eligible postmenopausal women. Participants were randomly classified into two groups to use either 700 mg valerian extract (group A or a placebo (group B for one month. After a 2-week washout period, the treatment regimens were reversed. Sleep quantity and quality were evaluated using Pittsburgh and Insomnia Severity Index (ISI questionnaires at baseline and after both phases of intervention. Results: Mean score of Pittsburgh scale was 10.93.6 at baseline. Valerian reduced this score to 7.83.4 and 7.43 at the first and the second phase of intervention, respectively (P<0.001. After the first phase of intervention, ISI score was reduced to 2.870.62 in group A (P<0.001. It was reduced to 4.020.5 in group B after the second phase of intervention (P<0.001. Conclusion: Daily consumption of 700 mg valerian improved sleep quantity and quality in postmenopausal women

  11. Design, construction, operation and performance of a Hadron Blind Detector for the PHENIX experiment

    International Nuclear Information System (INIS)

    Anderson, W.; Azmoun, B.; Cherlin, A.; Chi, C.Y.; Citron, Z.; Connors, M.; Dubey, A.; Durham, J.M.; Fraenkel, Z.; Hemmick, T.; Kamin, J.; Kozlov, A.; Lewis, B.; Makek, M.; Milov, A.; Naglis, M.; Pantuev, V.; Pisani, R.; Proissl, M.; Ravinovich, I.

    2011-01-01

    A Hadron Blind Detector (HBD) has been developed, constructed and successfully operated within the PHENIX detector at RHIC. The HBD is a Cherenkov detector operated with pure CF 4 . It has a 50 cm long radiator directly coupled in a windowless configuration to a readout element consisting of a triple GEM stack, with a CsI photocathode evaporated on the top surface of the top GEM and pad readout at the bottom of the stack. This paper gives a comprehensive account of the construction, operation and in-beam performance of the detector.

  12. CULTURE–INCLUSIVE TOILET DESIGN FOR YPAB BLIND SCHOOL IN SURABAYA

    Directory of Open Access Journals (Sweden)

    TANUWIDJAJA Gunawan

    2014-12-01

    Full Text Available Toileting culture affects the toileting design. Adaptive - inclusive toilet design strategy was needed to respond the local unique toileting culture of Surabaya people. Based on toileting culture and five Inclusive design principles directed by Tanuwidjaja, the inclusive toilet was produced. The project involved four steps such as: literature review, interview and photo documents, participative design workshops and design development. Therefore, a final design was produced and found acceptable for Surabaya people.

  13. A Placebo-Controlled, Blinded and Randomised Study on the Effects of Recombinant Human Thyrotropin on Quality of Life in the Treatment of Thyroid Cancer

    DEFF Research Database (Denmark)

    Nygaard, Birte; Bastholt, Lars; Bennedbæk, Finn Noe

    2013-01-01

    BACKGROUND: It is well known that thyroid hormone withdrawal (THW) in thyroid cancer patients can induce a decrease in quality of life (QOL). Recombinant human thyrotropin (rh-TSH) has been used to avoid this; however, no blinded studies have ever documented the effect. OBJECTIVE: To compare QOL...... in patients with differentiated thyroid cancer (DTC) treated with either rh-TSH or liothyronine (L-T3) THW for 10 days. STUDY DESIGN: Double-blind, randomised cross-over. PATIENTS: Fifty-six patients with DTC treated by total thyroidectomy and indication for postsurgery radioiodine (RI) ablation therapy...

  14. Space-Time Coded MC-CDMA: Blind Channel Estimation, Identifiability, and Receiver Design

    Directory of Open Access Journals (Sweden)

    Li Hongbin

    2002-01-01

    Full Text Available Integrating the strengths of multicarrier (MC modulation and code division multiple access (CDMA, MC-CDMA systems are of great interest for future broadband transmissions. This paper considers the problem of channel identification and signal combining/detection schemes for MC-CDMA systems equipped with multiple transmit antennas and space-time (ST coding. In particular, a subspace based blind channel identification algorithm is presented. Identifiability conditions are examined and specified which guarantee unique and perfect (up to a scalar channel estimation when knowledge of the noise subspace is available. Several popular single-user based signal combining schemes, namely the maximum ratio combining (MRC and the equal gain combining (EGC, which are often utilized in conventional single-transmit-antenna based MC-CDMA systems, are extended to the current ST-coded MC-CDMA (STC-MC-CDMA system to perform joint combining and decoding. In addition, a linear multiuser minimum mean-squared error (MMSE detection scheme is also presented, which is shown to outperform the MRC and EGC at some increased computational complexity. Numerical examples are presented to evaluate and compare the proposed channel identification and signal detection/combining techniques.

  15. Mechanical Structure Design Optimization by Blind Number Theory: Time-dependent Reliability

    OpenAIRE

    Zakari Yaou; Lirong Cui

    2012-01-01

    In a product development process, understanding the functional behavior of the system, the role of components in achieving functions and failure modes if components/subsystem fails its required function will help develop appropriate design validation and verification program for reliability assessment. The integration of these three issues will help design and reliability engineers in identifying weak spots in design and planning future actions and testing program. This case study demonstrate...

  16. Crossing Over. Stories of the transition, or ‘history from the inside’

    Directory of Open Access Journals (Sweden)

    R. Gaylard

    1997-04-01

    Full Text Available The collection of stories entitled Crossing Over: New Stories for a New South Africa (1995 commemorates a remarkable turning point in this country's history, the election of South Africa's first-ever democratic government. By inviting contributions from writers from a variety of backgrounds, and in any of the eleven official languages, the compilers hoped to provide "a rounded picture of our times” and to contribute to the making of a new South African culture of inclusivity. Contributors were asked for stories dealing with "some kind of crossing over," and exploring the response of young people to the transition. In spite of limitations as regards representativeness, the collection does bring together an unusually varied group of writers. This article explores the extent to which, by promoting a renewed awareness of "self” in relation to "others", the anthology goes some way towards uncovering and undoing the racism and stereotyping that have been endemic to our society. In doing so, it provides us with a kind of "history from the inside”. However, the collection also demonstrates the continuing presence of the past, and suggests the extent to which the lives of many ordinary people have not changed significantly.

  17. A water-based training program that include perturbation exercises to improve stepping responses in older adults: study protocol for a randomized controlled cross-over trial

    Directory of Open Access Journals (Sweden)

    Tsedek Irit

    2008-08-01

    Full Text Available Abstract Background Gait and balance impairments may increase the risk of falls, the leading cause of accidental death in the elderly population. Fall-related injuries constitute a serious public health problem associated with high costs for society as well as human suffering. A rapid step is the most important protective postural strategy, acting to recover equilibrium and prevent a fall from initiating. It can arise from large perturbations, but also frequently as a consequence of volitional movements. We propose to use a novel water-based training program which includes specific perturbation exercises that will target the stepping responses that could potentially have a profound effect in reducing risk of falling. We describe the water-based balance training program and a study protocol to evaluate its efficacy (Trial registration number #NCT00708136. Methods/Design The proposed water-based training program involves use of unpredictable, multi-directional perturbations in a group setting to evoke compensatory and volitional stepping responses. Perturbations are made by pushing slightly the subjects and by water turbulence, in 24 training sessions conducted over 12 weeks. Concurrent cognitive tasks during movement tasks are included. Principles of physical training and exercise including awareness, continuity, motivation, overload, periodicity, progression and specificity were used in the development of this novel program. Specific goals are to increase the speed of stepping responses and improve the postural control mechanism and physical functioning. A prospective, randomized, cross-over trial with concealed allocation, assessor blinding and intention-to-treat analysis will be performed to evaluate the efficacy of the water-based training program. A total of 36 community-dwelling adults (age 65–88 with no recent history of instability or falling will be assigned to either the perturbation-based training or a control group (no training

  18. [Sampling and measurement methods of the protocol design of the China Nine-Province Survey for blindness, visual impairment and cataract surgery].

    Science.gov (United States)

    Zhao, Jia-liang; Wang, Yu; Gao, Xue-cheng; Ellwein, Leon B; Liu, Hu

    2011-09-01

    To design the protocol of the China nine-province survey for blindness, visual impairment and cataract surgery to evaluate the prevalence and main causes of blindness and visual impairment, and the prevalence and outcomes of the cataract surgery. The protocol design was began after accepting the task for the national survey for blindness, visual impairment and cataract surgery from the Department of Medicine, Ministry of Health, China, in November, 2005. The protocol in Beijing Shunyi Eye Study in 1996 and Guangdong Doumen County Eye Study in 1997, both supported by World Health Organization, was taken as the basis for the protocol design. The relative experts were invited to discuss and prove the draft protocol. An international advisor committee was established to examine and approve the draft protocol. Finally, the survey protocol was checked and approved by the Department of Medicine, Ministry of Health, China and Prevention Program of Blindness and Deafness, WHO. The survey protocol was designed according to the characteristics and the scale of the survey. The contents of the protocol included determination of target population and survey sites, calculation of the sample size, design of the random sampling, composition and organization of the survey teams, determination of the examinee, the flowchart of the field work, survey items and methods, diagnostic criteria of blindness and moderate and sever visual impairment, the measures of the quality control, the methods of the data management. The designed protocol became the standard and practical protocol for the survey to evaluate the prevalence and main causes of blindness and visual impairment, and the prevalence and outcomes of the cataract surgery.

  19. Blind Quantum Signature with Blind Quantum Computation

    Science.gov (United States)

    Li, Wei; Shi, Ronghua; Guo, Ying

    2017-04-01

    Blind quantum computation allows a client without quantum abilities to interact with a quantum server to perform a unconditional secure computing protocol, while protecting client's privacy. Motivated by confidentiality of blind quantum computation, a blind quantum signature scheme is designed with laconic structure. Different from the traditional signature schemes, the signing and verifying operations are performed through measurement-based quantum computation. Inputs of blind quantum computation are securely controlled with multi-qubit entangled states. The unique signature of the transmitted message is generated by the signer without leaking information in imperfect channels. Whereas, the receiver can verify the validity of the signature using the quantum matching algorithm. The security is guaranteed by entanglement of quantum system for blind quantum computation. It provides a potential practical application for e-commerce in the cloud computing and first-generation quantum computation.

  20. Specific and cross over effects of massage for muscle soreness: randomized controlled trial.

    Science.gov (United States)

    Jay, Kenneth; Sundstrup, Emil; Søndergaard, Stine D; Behm, David; Brandt, Mikkel; Særvoll, Charlotte A; Jakobsen, Markus D; Andersen, Lars L

    2014-02-01

    Muscle soreness can negatively interfere with the activities of daily living as well as sports performance. In the working environment, a common problem is muscle tenderness, soreness and pain, especially for workers frequently exposed to unilateral high repetitive movements tasks. The aim of the study is therefore to investigate the acute effect of massage applied using a simple device Thera-band roller Massager on laboratory induced hamstring muscle soreness, and the potential cross over effect to the non-massaged limb. 22 healthy untrained men (Mean age 34 +/- 7 years; mean height 181.7 +/- 6.9 cm; mean weight 80.6 +/- 6.4 kg; BMI: 24.5 +/- 1.3) with no prior history of knee, low back or neck injury or other adverse health issues were recruited. Participants visited the researchers on two separate occasions, separated by 48 hours, each time providing a soreness rating (modified visual analog scale 0-10), and being tested for pressure pain threshold (PPT) and active range of motion (ROM) of the hamstring muscles. During the first visit, delayed onset muscular soreness of the hamstring muscles was induced by 10 x 10 repetitions of the stiff-legged dead-lift. On the second visit participants received either 1) 10 minutes of roller massage on one leg, while the contralateral leg served as a cross over control, or 2) Resting for 10 minutes with no massage at all. Measurement of soreness, PPT and ROM were taken immediately before and at 0, 10, 30 and 60 min. after treatment. There was a significant group by time interaction for soreness (p soreness and increasing PPT compared with the control group. There was no group by time interaction for ROM (p = 0.18). At 10 min. post massage there was a significant reduction in soreness of the non-massaged limb in the cross over control group compared to controls but this effect was lost 30 minutes post massage. Massage with a roller device reduces muscle soreness and is accompanied by a higher PPT of the affected muscle. 2c

  1. Influence of acute consumption of caffeine vs. placebo over Bia-derived measurements of body composition: a randomized, double-blind, crossover design.

    Science.gov (United States)

    Williamson, Cassie M; Nickerson, Brett S; Bechke, Emily E; McLester, Cherilyn N; Kliszczewicz, Brian M

    2018-01-01

    Bioelectrical impedance analysis (BIA) is often used to estimate total body water (TBW), intracellular body water (ICW), extracellular body water (ECW), and body fat percentage (BF%). A common restriction for BIA analysis is abstinence from caffeine 12-h prior to testing. However, research has yet to determine whether the consumption of caffeine influences BIA testing results. The purpose of this study was to determine if the consumption of caffeine influences BIA-derived BF% and body water values in habitual caffeine users. Twenty apparently healthy males (26.6 ± 4.1 years) identified as habitual caffeine consumers (≥ one 95 mg serving per day ≥ four days per week) participated in this study. Participants came to the lab on three occasions, the first visit serving as the control (CON) with no supplementation. The remaining two visits were performed in a randomized double-blind, cross-over fashion. Participants consumed 200 mg of dextrose (PLA) or caffeine (CAF) in capsule form. During each visit, seven multi-frequency BIA measurements were conducted before (PRE) and after (15-min, 30-min, 45-min, 60-min, 75-min, 90-min) consumption. Repeated measures ANOVA revealed BF% for CAF was lower than the CON and PLA conditions at PRE and 15-min ( p  Caffeine consumption in habitual users produced trivial changes in TBW, ECW, ICW, or BF%. Therefore, the pre-testing guidelines for caffeine consumption may not be necessary in habitual caffeine consumers.

  2. Design of Low-Cost FPGA Hardware for Real-time ICA-Based Blind Source Separation Algorithm

    Directory of Open Access Journals (Sweden)

    Farook Sattar

    2005-11-01

    Full Text Available Blind source separation (BSS of independent sources from their convolutive mixtures is a problem in many real-world multisensor applications. In this paper, we propose and implement an efficient FPGA hardware architecture for the realization of a real-time BSS. The architecture can be implemented using a low-cost FPGA (field programmable gate array. The architecture offers a good balance between hardware requirement (gate count and minimal clock speed and separation performance. The FPGA design implements the modified Torkkola's BSS algorithm for audio signals based on ICA (independent component analysis technique. Here, the separation is performed by implementing noncausal filters, instead of the typical causal filters, within the feedback network. This reduces the required length of the unmixing filters as well as provides better separation and faster convergence. Description of the hardware as well as discussion of some issues regarding the practical hardware realization are presented. Results of various FPGA simulations as well as real-time testing of the final hardware design in real environment are given.

  3. Genomic identification and quantification of microbial species adhering to toothbrush bristles after disinfection: A cross-over study.

    Science.gov (United States)

    do Nascimento, Cássio; Trinca, Nayara Nascimento; Pita, Murillo Sucena; Pedrazzi, Vinícius

    2015-07-01

    The aim of this clinical investigation was to identify and quantify the microbial species adhering to toothbrush bristles after controlled brushing and storage in different antimicrobial agents. Sixteen healthy participants were enrolled in this study and randomly submitted to 4 interventions in a cross-over design: brushing and toothbrush storage in (I) Periogard/(II) Periobio (Chlorhexidine gluconate 0.12%), (III) Cepacol (cetylpyridinium chloride 0.05%) and (IV) distilled water (positive control). Thirty-eight bacterial species including putative pathogens and 5 Candida spp. were assessed by Checkerboard DNA-DNA hybridization. The results of the study have shown a striking reduction of the total microbial counts, including bacteria and Candida spp., on the toothbrush bristles after storage in cetylpyridinium chloride 0.05% (p 0.05). Cetylpyridinium chloride solution also presented the lowest genome counts and frequency of detection for individual target species; distilled water showed the highest individual genome counts (p < 0.05). Potential pathogenic species were recorded in moderate to high levels for chlorhexidine gluconate and distilled water. Cetylpyridinium chloride 0.05% was the most effective storage solution in the reduction of total and individual microbial counts, including pathogenic species. Copyright © 2015 Elsevier Ltd. All rights reserved.

  4. Bone mineral density in young adults with Prader-Willi syndrome: a randomized, placebo-controlled, cross-over GH trial.

    Science.gov (United States)

    Donze, Stephany H; Kuppens, Renske J; Bakker, Nienke E; van Alfen-van der Velden, Janiëlle A E M; Hokken-Koelega, Anita C S

    2018-02-08

    The prevalence of osteoporosis is increased in adults with Prader-Willi syndrome (PWS). In children with PWS, growth hormone (GH) treatment has beneficial effects on bone mineral density (BMD). BMD might deteriorate after cessation of GH at adult height (AH), while continuing GH might maintain BMD. To investigate the effects of GH versus placebo, and furthermore the effects of sex steroid replacement therapy (SSRT), on BMD in GH-treated young adults with PWS who had attained AH. two-year, randomized, double-blind, placebo-controlled, cross-over GH study. 27 young adults with PWS, stratified for gender and BMI. All patients were randomly and blindly assigned to receive GH (0.67 mg/m 2 /day) and placebo, both during one year. Bone mineral density of the total body (BMD TB ) and lumbar spine (BMD LS ) SDS, measured by dual energy x-ray absorptiometry. At AH, BMD TB SDS was significantly lower compared to healthy peers (pyoung adults without SSRT, BMD TB SDS and BMAD LS SDS decreased during the two-year study (p=0.11 and p=0.01), regardless of GH or placebo, while BMD TB SDS increased in those with SSRT (pyoung adults with PWS. In addition, our data suggest that GH is not able to prevent the decline in BMD SDS in hypogonadal young adults with PWS, unless it is combined with SSRT. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  5. DNA repair and crossing over favor similar chromosome regions as discovered in radiation hybrid of Triticum

    Directory of Open Access Journals (Sweden)

    Kumar Ajay

    2012-07-01

    Full Text Available Abstract Background The uneven distribution of recombination across the length of chromosomes results in inaccurate estimates of genetic to physical distances. In wheat (Triticum aestivum L. chromosome 3B, it has been estimated that 90% of the cross over events occur in distal sub-telomeric regions representing 40% of the chromosome. Radiation hybrid (RH mapping which does not rely on recombination is a strategy to map genomes and has been widely employed in animal species and more recently in some plants. RH maps have been proposed to provide i higher and ii more uniform resolution than genetic maps, and iii to be independent of the distribution patterns observed for meiotic recombination. An in vivo RH panel was generated for mapping chromosome 3B of wheat in an attempt to provide a complete scaffold for this ~1 Gb segment of the genome and compare the resolution to previous genetic maps. Results A high density RH map with 541 marker loci anchored to chromosome 3B spanning a total distance of 1871.9 cR was generated. Detailed comparisons with a genetic map of similar quality confirmed that i the overall resolution of the RH map was 10.5 fold higher and ii six fold more uniform. A significant interaction (r = 0.879 at p = 0.01 was observed between the DNA repair mechanism and the distribution of crossing-over events. This observation could be explained by accepting the possibility that the DNA repair mechanism in somatic cells is affected by the chromatin state in a way similar to the effect that chromatin state has on recombination frequencies in gametic cells. Conclusions The RH data presented here support for the first time in vivo the hypothesis of non-casual interaction between recombination hot-spots and DNA repair. Further, two major hypotheses are presented on how chromatin compactness could affect the DNA repair mechanism. Since the initial RH application 37 years ago, we were able to show for the first time that the iii

  6. Glassy Chimeras Could Be Blind to Quantum Speedup: Designing Better Benchmarks for Quantum Annealing Machines

    Directory of Open Access Journals (Sweden)

    Helmut G. Katzgraber

    2014-04-01

    Full Text Available Recently, a programmable quantum annealing machine has been built that minimizes the cost function of hard optimization problems by, in principle, adiabatically quenching quantum fluctuations. Tests performed by different research teams have shown that, indeed, the machine seems to exploit quantum effects. However, experiments on a class of random-bond instances have not yet demonstrated an advantage over classical optimization algorithms on traditional computer hardware. Here, we present evidence as to why this might be the case. These engineered quantum annealing machines effectively operate coupled to a decohering thermal bath. Therefore, we study the finite-temperature critical behavior of the standard benchmark problem used to assess the computational capabilities of these complex machines. We simulate both random-bond Ising models and spin glasses with bimodal and Gaussian disorder on the D-Wave Chimera topology. Our results show that while the worst-case complexity of finding a ground state of an Ising spin glass on the Chimera graph is not polynomial, the finite-temperature phase space is likely rather simple because spin glasses on Chimera have only a zero-temperature transition. This means that benchmarking optimization methods using spin glasses on the Chimera graph might not be the best benchmark problems to test quantum speedup. We propose alternative benchmarks by embedding potentially harder problems on the Chimera topology. Finally, we also study the (reentrant disorder-temperature phase diagram of the random-bond Ising model on the Chimera graph and show that a finite-temperature ferromagnetic phase is stable up to 19.85(15% antiferromagnetic bonds. Beyond this threshold, the system only displays a zero-temperature spin-glass phase. Our results therefore show that a careful design of the hardware architecture and benchmark problems is key when building quantum annealing machines.

  7. Calcium from salmon and cod bone is well absorbed in young healthy men: a double-blinded randomised crossover design.

    Science.gov (United States)

    Malde, Marian K; Bügel, Susanne; Kristensen, Mette; Malde, Ketil; Graff, Ingvild E; Pedersen, Jan I

    2010-07-20

    Calcium (Ca) - fortified foods are likely to play an important role in helping the consumer achieve an adequate Ca intake, especially for persons with a low intake of dairy products. Fish bones have a high Ca content, and huge quantities of this raw material are available as a by-product from the fish industry. Previously, emphasis has been on producing high quality products from fish by-products by use of bacterial proteases. However, documentation of the nutritional value of the enzymatically rinsed Ca-rich bone fraction remains unexplored. The objective of the present study was to assess the bioavailability of calcium in bones of Atlantic salmon (oily fish) and Atlantic cod (lean fish) in a double-blinded randomised crossover design. Ca absorption was measured in 10 healthy young men using 47Ca whole body counting after ingestion of a test meal extrinsically labelled with the 47Ca isotope. The three test meals contained 800 mg of Ca from three different calcium sources: cod bones, salmon bones and control (CaCO3). Mean Ca absorption (+/- SEE) from the three different Ca sources were 21.9 +/- 1.7%, 22.5 +/- 1.7% and 27.4 +/- 1.8% for cod bones, salmon bones, and control (CaCO3), respectively. We conclude that bones from Atlantic salmon and Atlantic cod are suitable as natural Ca sources in e.g. functional foods or as supplements.

  8. Calcium from salmon and cod bone is well absorbed in young healthy men: a double-blinded randomised crossover design

    Directory of Open Access Journals (Sweden)

    Graff Ingvild E

    2010-07-01

    Full Text Available Abstract Background Calcium (Ca - fortified foods are likely to play an important role in helping the consumer achieve an adequate Ca intake, especially for persons with a low intake of dairy products. Fish bones have a high Ca content, and huge quantities of this raw material are available as a by-product from the fish industry. Previously, emphasis has been on producing high quality products from fish by-products by use of bacterial proteases. However, documentation of the nutritional value of the enzymatically rinsed Ca-rich bone fraction remains unexplored. The objective of the present study was to assess the bioavailability of calcium in bones of Atlantic salmon (oily fish and Atlantic cod (lean fish in a double-blinded randomised crossover design. Methods Ca absorption was measured in 10 healthy young men using 47Ca whole body counting after ingestion of a test meal extrinsically labelled with the 47Ca isotope. The three test meals contained 800 mg of Ca from three different calcium sources: cod bones, salmon bones and control (CaCO3. Results Mean Ca absorption (± SEE from the three different Ca sources were 21.9 ± 1.7%, 22.5 ± 1.7% and 27.4 ± 1.8% for cod bones, salmon bones, and control (CaCO3, respectively. Conclusion We conclude that bones from Atlantic salmon and Atlantic cod are suitable as natural Ca sources in e.g. functional foods or as supplements.

  9. HTP-3 links DSB formation with homolog pairing and crossing over during C. elegans meiosis.

    Science.gov (United States)

    Goodyer, William; Kaitna, Susanne; Couteau, Florence; Ward, Jordan D; Boulton, Simon J; Zetka, Monique

    2008-02-01

    Repair of the programmed meiotic double-strand breaks (DSBs) that initiate recombination must be coordinated with homolog pairing to generate crossovers capable of directing chromosome segregation. Chromosome pairing and synapsis proceed independently of recombination in worms and flies, suggesting a paradoxical lack of coregulation. Here, we find that the meiotic axis component HTP-3 links DSB formation with homolog pairing and synapsis. HTP-3 forms complexes with the DSB repair components MRE-11/RAD-50 and the meiosis-specific axis component HIM-3. Loss of htp-3 or mre-11 recapitulates meiotic phenotypes consistent with a failure to generate DSBs, suggesting that HTP-3 associates with MRE-11/RAD-50 in a complex required for meiotic DSB formation. Loss of HTP-3 eliminates HIM-3 localization to axes and HIM-3-dependent homolog alignment, synapsis, and crossing over. Our study reveals a mechanism for coupling meiotic DSB formation with homolog pairing through the essential participation of an axis component with complexes mediating both processes.

  10. Carbohydrate intake and training efficacy - a randomized cross-over study.

    Science.gov (United States)

    Beaudouin, Florian; Joerg, Frederic; Hilpert, Anette; Meyer, Tim; Hecksteden, Anne

    2018-04-01

    Carbohydrate (CHO) availability during endurance exercise seems to attenuate exercise-induced perturbations of cellular homeostasis and might consequently diminish the stimulus for training adaptation. Therefore, a negative effect of CHO intake on endurance training efficacy seems plausible. This study aimed to test the influence of carbohydrate intake on the efficacy of an endurance training program on previously untrained healthy adults. A randomized cross-over trial (8-week wash-out period) was conducted in 23 men and women with two 8-week training periods (with vs. without intake of 50g glucose before each training bout). Training intervention consisted of 4x45 min running/walking sessions/week at 70% of heart rate reserve. Exhaustive, ramp-shaped exercise tests with gas exchange measurements were conducted before and after each training period. Outcome measures were maximum oxygen uptake (VO 2max ) and ventilatory anaerobic threshold (VT). VO 2max and VT increased after training regardless of CHO intake (VO 2max : Non-CHO 2.6 ± 3.0 ml*min -1 *kg -1 p = 0.004; CHO 1.4 ± 2.5 ml*min -1 *kg -1 p = 0.049; VT: Non-CHO 4.2 ± 4.2 ml*min -1 *kg -1 p training program.

  11. Proceedings of the cross-over symposium `new approaches for studies on environmental radioactivity`

    Energy Technology Data Exchange (ETDEWEB)

    Matsumoto, Shiro [Saitama Univ., Urawa (Japan); Uchida, Shigeo; Yamazawa, Hiromi; Amano, Hikaru [eds.

    1999-03-01

    This conference was organized by the Promotion Committee on Nuclear Cross-Over Research and the Specialist Committee on Assessment and Reduction of Radiation Risks, and co-organized by Microbial Toxicology Lab., RIKEN and Environmental Chemistry Lab., JAERI. In 1991, a project on transfer models and parameters of radionuclides in terrestrial environment was started in the Specialist Committee on Assessment and Reduction of Radiation Risks. This project was finished successfully to have active cooperation of different organizations which were Japan Atomic Energy Research Institute (JAERI), Meteorological Research Institute (MRI), National Institute of Radiological Sciences (NIRS), the Institute of Physical and Chemical Research (RIKEN) and Power Reactor and Nuclear Fuel Development Corporation (PNC). Subsequently, we started a new project named `Development of dynamic models of transfer of radionuclides in the terrestrial environment` with adding a new member, Institute for Environmental Sciences (IES) from 1996. The results we obtained so far were presented in this conference. The 20 of the presented papers are indexed individually. (J.P.N.)

  12. Proceedings of the cross-over symposium 'new approaches for studies on environmental radioactivity'

    International Nuclear Information System (INIS)

    Matsumoto, Shiro; Uchida, Shigeo; Yamazawa, Hiromi; Amano, Hikaru

    1999-03-01

    This conference was organized by the Promotion Committee on Nuclear Cross-Over Research and the Specialist Committee on Assessment and Reduction of Radiation Risks, and co-organized by Microbial Toxicology Lab., RIKEN and Environmental Chemistry Lab., JAERI. In 1991, a project on transfer models and parameters of radionuclides in terrestrial environment was started in the Specialist Committee on Assessment and Reduction of Radiation Risks. This project was finished successfully to have active cooperation of different organizations which were Japan Atomic Energy Research Institute (JAERI), Meteorological Research Institute (MRI), National Institute of Radiological Sciences (NIRS), the Institute of Physical and Chemical Research (RIKEN) and Power Reactor and Nuclear Fuel Development Corporation (PNC). Subsequently, we started a new project named 'Development of dynamic models of transfer of radionuclides in the terrestrial environment' with adding a new member, Institute for Environmental Sciences (IES) from 1996. The results we obtained so far were presented in this conference. The 20 of the presented papers are indexed individually. (J.P.N.)

  13. Acute effects of reducing sitting time in adolescents: a randomized cross-over study.

    Science.gov (United States)

    Penning, Anisse; Okely, Anthony D; Trost, Stewart G; Salmon, Jo; Cliff, Dylan P; Batterham, Marijka; Howard, Steven; Parrish, Anne-Maree

    2017-08-15

    Levels of sitting among adolescents are high, especially during the school day. The acute cognitive and health consequences associated with prolonged sitting are poorly understood in adolescents. This randomized crossover design study examined the acute effects of a simulated school day with reduced sitting or usual sitting on adolescents' cognitive function and cardiometabolic biomarkers. Eighteen healthy school aged adolescents were recruited from the community to the study (11 males; 7 females; mean age [SD] = 13.5 ± 0.9 years). Two protocols were developed to simulate an adolescent school day, the amount of time spent sitting was manipulated reflecting: a 'typical' day (65% of the time spent sitting with two sitting bouts sitting >20 min) and a 'reduced sitting' day (adolescents sat for 50% less time with no bouts of sitting >20 mins). The order that participants were exposed to each condition was randomized (via random number generator). Participants were not fully blinded as they could observe the difference between conditions. Energy intake and moderate to vigorous physical activity (MVPA) were standardized for both conditions and monitored for 48 h post-condition for compensatory effects. Cognitive (working memory) and cardiometabolic outcomes (lipids, glucose, insulin, IL-6, apo-A1, apo-B, blood pressure,) were assessed pre and post for both conditions, BMI and body fat were assessed on the morning of the intervention. Data were analyzed using linear mixed models. Standardised effect sizes were calculated. Compared with the typical school day, the reduced sitting day demonstrated significant positive effects for apoB/apoA-1 ratio (adjusted difference ± SD) -0.02 ± 0.03; P = 0.03; effect size [Cohen's d] = -0.67. Findings for total cholesterol -0.19 ± 0.27; P = 0.28; d = -0.71; HDL cholesterol -0.23 ± 0.50; P = 0.12 d = -0.66; and total cholesterol/HDL ratio 0.25 ± 0.53; P = 0.25; d = 0.51 and for cognition 0.64 ± 0

  14. Conditional Poisson models: a flexible alternative to conditional logistic case cross-over analysis.

    Science.gov (United States)

    Armstrong, Ben G; Gasparrini, Antonio; Tobias, Aurelio

    2014-11-24

    The time stratified case cross-over approach is a popular alternative to conventional time series regression for analysing associations between time series of environmental exposures (air pollution, weather) and counts of health outcomes. These are almost always analyzed using conditional logistic regression on data expanded to case-control (case crossover) format, but this has some limitations. In particular adjusting for overdispersion and auto-correlation in the counts is not possible. It has been established that a Poisson model for counts with stratum indicators gives identical estimates to those from conditional logistic regression and does not have these limitations, but it is little used, probably because of the overheads in estimating many stratum parameters. The conditional Poisson model avoids estimating stratum parameters by conditioning on the total event count in each stratum, thus simplifying the computing and increasing the number of strata for which fitting is feasible compared with the standard unconditional Poisson model. Unlike the conditional logistic model, the conditional Poisson model does not require expanding the data, and can adjust for overdispersion and auto-correlation. It is available in Stata, R, and other packages. By applying to some real data and using simulations, we demonstrate that conditional Poisson models were simpler to code and shorter to run than are conditional logistic analyses and can be fitted to larger data sets than possible with standard Poisson models. Allowing for overdispersion or autocorrelation was possible with the conditional Poisson model but when not required this model gave identical estimates to those from conditional logistic regression. Conditional Poisson regression models provide an alternative to case crossover analysis of stratified time series data with some advantages. The conditional Poisson model can also be used in other contexts in which primary control for confounding is by fine

  15. Rationale and design of decision: a double-blind, randomized, placebo-controlled phase III trial evaluating the efficacy and safety of sorafenib in patients with locally advanced or metastatic radioactive iodine (RAI)-refractory, differentiated thyroid cancer

    International Nuclear Information System (INIS)

    Brose, Marcia S; Schlumberger, Martin; Nutting, Christopher M; Sherman, Steven I; Shong, Young Kee; Smit, Johannes WA; Reike, Gerhard; Chung, John; Kalmus, Joachim; Kappeler, Christian

    2011-01-01

    The incidence of thyroid cancer and the number of patients who die from this disease are increasing globally. Differentiated thyroid cancer (DTC) is the histologic subtype present in most patients and is primarily responsible for the increased overall incidence of thyroid cancer. Sorafenib is a multikinase inhibitor that targets several molecular signals believed to be involved in the pathogenesis of thyroid cancer, including those implicated in DTC. In phase II studies of patients with DTC, sorafenib treatment has yielded a median progression-free survival (PFS) of 58 to 84 weeks and disease control rates of 59% to 100%. The DECISION trial was designed to assess the ability of sorafenib to improve PFS in patients with locally advanced or metastatic, radioactive iodine (RAI)-refractory DTC. DECISION is a multicenter, double-blind, randomized, placebo-controlled phase III study in patients with locally advanced/metastatic RAI-refractory DTC. Study treatment will continue until radiographically documented disease progression, unacceptable toxicity, noncompliance, or withdrawal of consent. Efficacy will be evaluated every 56 days (2 cycles), whereas safety will be evaluated every 28 days (1 cycle) for the first 8 months and every 56 days thereafter. Following disease progression, patients may continue or start sorafenib, depending on whether they were randomized to receive sorafenib or placebo, at investigator discretion. Patients originally randomized to receive sorafenib will be followed up every 3 months for overall survival (OS); patients originally randomized to receive placebo will be followed up every month for 8 months after cross-over to sorafenib. The duration of the trial is expected to be 30 months from the time the first patient is randomized until the planned number of PFS events is attained. The primary endpoint is PFS; secondary endpoints include OS, time to disease progression, disease control rate, response rate, duration of response, safety, and

  16. Adolescents' ability to select healthy food using two different front-of-pack food labels: a cross-over study.

    Science.gov (United States)

    Babio, Nancy; Vicent, Paloma; López, Leonor; Benito, Anna; Basulto, Julio; Salas-Salvadó, Jordi

    2014-06-01

    To compare, in adolescents, two models of front-of-pack Guideline Daily Amounts (GDA) labels in terms of (i) friendliness and acceptance and (ii) the ability to choose a diet that closely follows the nutritional recommendations. A randomized cross-over study was designed to compare two simplified front-of-pack GDA nutrition labels. A Spanish secondary school. Eighty-one healthy adolescents aged between 14 and 16 years were recruited. Participants were randomly exposed to two experimental non-real food-choice conditions using multiple-traffic-light or monochrome nutritional labels. Participants had to choose options from a closed menu for 5 d on the basis of the experimental front-of-pack labelling. For each meal, three food options with different nutritional compositions were given to the participants. The contents of total energy and fat, saturated fat, sugar and salt of the chosen options were calculated. There were no significant differences in baseline sociodemographic and anthropometric characteristics between participants regardless of the experimental condition in which they started. There were no carry-over effects between the experimental sequences. It was observed that when participants used the multiple-traffic-light GDA system they chose significantly less total energy (mean -123·1 (sd 211·0) kJ (-29·4 (sd 50·4) kcal), P front-of-pack nutritional label, the multiple-traffic-light system helped adolescents to differentiate between healthier and less healthy food, theoretically making it possible for them to choose a diet closer to dietary recommendations.

  17. Testing the validity of telephone interviews to assess chronic pain in children and adolescents: A randomized cross-over trial.

    Science.gov (United States)

    Wager, J; Barth, F; Stahlschmidt, L; Zernikow, B

    2017-11-01

    Telephone surveys are intended to reduce attrition in longitudinal studies. For paediatric chronic pain patients, the comparability of pain-related information gathered using telephone interviews and postal surveys remain unknown. Furthermore, it remains unknown how social desirability may influence answers. To compare data from telephone interviews and postal surveys, a randomized cross-over design with two measure points 2 weeks apart and four conditions (combinations of telephone interviews (T) and postal surveys (P): P-T, T-P, P-P, T-T) was conducted in a sample of N = 323 paediatric chronic pain patients. In the inter-group comparison, pain-related information did not differ between telephone interviews and postal surveys except for the information on pain location (back and extremities). Agreement measures of the intra-group comparisons suggest substantial to excellent agreements for all items and did not differ between the groups. The internal consistency of a disability scale was excellent for both assessment modes; the number of missing values did not differ. Participation rate was higher for telephone interviews compared to the postal surveys. Across both time points, attrition was lowest for the groups without a switch in assessment mode compared to the groups with a switch in assessment mode. Except for pain-related school absence, no effect of social desirability occurred. Telephone interviews are a useful method to achieve a high response rate. Pain locations should be asked for separately and not in an open question when interviewing children and adolescents on the telephone. Telephone interviews are a good method to achieve a high response rate and obtain valid data in studies with paediatric chronic pain patients. © 2017 European Pain Federation - EFIC®.

  18. Efficacy of ethanol-based hand foams using clinically relevant amounts: a cross-over controlled study among healthy volunteers

    Directory of Open Access Journals (Sweden)

    Marschall Sigunde

    2010-03-01

    Full Text Available Abstract Background Foams containing 62% ethanol are used for hand decontamination in many countries. A long drying time may reduce the compliance of healthcare workers in applying the recommended amount of foam. Therefore, we have investigated the correlation between the applied amount and drying time, and the bactericidal efficacy of ethanol foams. Methods In a first part of tests, four foams (Alcare plus, Avagard Foam, Bode test foam, Purell Instant Hand Sanitizer containing 62% ethanol, which is commonly used in U.S. hospitals, were applied to 14 volunteers in a total of seven variations, to measure drying times. In a second part of tests, the efficacy of the established amount of foam for a 30 s application time of two foams (Alcare plus, Purell Instant Hand Sanitizer and water was compared to the EN 1500 standard of 2 × 3 mL applications of 2-propanol 60% (v/v, on hands artificially contaminated with Escherichia coli. Each application used a cross-over design against the reference alcohol with 15 volunteers. Results The mean weight of the applied foam varied between 1.78 and 3.09 g, and the mean duration to dryness was between 37 s and 103 s. The correlation between the amount of foam applied and time until hands felt dry was highly significant (p 10-reduction: 3.05 ± 0.45 and Alcare plus (3.58 ± 0.71 was significantly less effective than the reference disinfection (4.83 ± 0.89 and 4.60 ± 0.59, respectively; p 10-reduction of 2.39 ± 0.57. Conclusions When using 62% ethanol foams, the time required for dryness often exceeds the recommended 30 s. Therefore, only a small volume is likely to be applied in clinical practice. Small amounts, however, failed to meet the efficacy requirements of EN 1500 and were only somewhat more effective than water.

  19. Recommended dairy product intake modulates circulating fatty acid profile in healthy adults: a multi-centre cross-over study.

    Science.gov (United States)

    Abdullah, Mohammad M H; Cyr, Audrey; Lépine, Marie-Claude; Labonté, Marie-Ève; Couture, Patrick; Jones, Peter J H; Lamarche, Benoît

    2015-02-14

    Dairy products are rich sources of an array of fatty acids (FA) that have been shown individually and in certain clusters to exert varying effects on cardiovascular health, for which the circulating lipid profile is a powerful biomarker. Whether the profile of these FA is reflected in blood upon short terms of intake, possibly contributing to the lipid-related health impacts of dairy products, remains to be fully established. The objectives of the present study were to assess a recommended dairy product consumption in relation to circulating FA and lipid profiles, and to evaluate certain FA in dairy fat as potential biomarkers of intake. In a free-living, multi-centre, cross-over design, 124 healthy individuals consumed 3 servings/d of commercial dairy (DAIRY; 1% fat milk, 1·5% fat yogurt and 34% fat cheese) or energy-equivalent control (CONTROL; fruit and vegetable juice, cashews and a cookie) products for 4 weeks each, separated by a 4-week washout period. Plasma FA and serum lipid profiles were assessed by standard methods at the end of each dietary phase. After 4 weeks of intake, plasma levels of FA pentadecanoic acid (15 : 0) and heptadecanoic acid (17 : 0) were higher (0·26 v. 0·22% and 0·42 v. 0·39% of the total identified FA, respectively) after the DAIRY phase than after the CONTROL phase (Pcholesterol levels after the DAIRY phase compared with the CONTROL phase (+0·08 mmol/l; P= 0·04). In conclusion, intake of 3 servings/d of conventional dairy products may modify certain circulating FA and lipid profiles within 4 weeks, where 15 : 0 and 17 : 0 may be potential short-term biomarkers of intake.

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

    Directory of Open Access Journals (Sweden)

    Karen Windey

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

  1. Shape of snack foods does not predict snack intake in a sample of preschoolers: a cross-over study

    Directory of Open Access Journals (Sweden)

    Boyer Lauren E

    2012-08-01

    Full Text Available Abstract Background In the past decade, the proportion snacking has increased. Snack foods consumed are predominantly not nutritious foods. One potential venue to increase children’s diet quality is to offer healthy snack foods and we explored if shaped snack foods would lead to increased consumption. Methods We investigated the consumption of high-fiber snacks (banana bread, pancakes, and sandwiches served either in normal (round, square or shaped (heart, hands, animals form to preschoolers 2–5 years old attending a local child care center (n = 21. The 9 weeks long, prospective, cross-over intervention study was designed to expose each child repeatedly to each snack in each shape (4 times per snack. Snacks were served as morning or afternoon snack and caretakers’ reports were used to account for the child’s consumption of a meal preceding the study snack (breakfast or lunch. Results There was no significant difference in snack consumption between the shaped and normal snacks. However, the mean energy intake from snacks was significantly greater for Caucasian children compared with Asian children. Further, Asian children consumed much less banana bread than the other two snacks. Overall, children who had not eaten breakfast or lunch prior to the morning or afternoon snack ate significantly more calories from the snacks (84.1 kcal, p-value  Conclusion Findings of this study confirm previous research that the shape of the foods does not affect snack consumption in children. However, we also report two unexpected findings: a the strong interaction between ethnicity and snack consumption and b that Asian children consumed much less banana bread than Caucasian children. The role of children’s ethnic background profoundly affects snack preference and must be considered in the study of children’s eating behaviors and in interventions to promote healthy eating habits.

  2. Treatment of Palmar Hyperhidrosis with Tap Water Iontophoresis: A Randomized, Sham-Controlled, Single-Blind, and Parallel-Designed Clinical Trial

    OpenAIRE

    Kim, Do Hun; Kim, Tae Han; Lee, Seung Ho; Lee, Ai Young

    2017-01-01

    Background Palmar hyperhidrosis is a common disorder of excessive sweating. A number of studies have demonstrated the effectiveness of iontophoresis in the treatment of palmar hyperhidrosis. However, controlled clinical studies on iontophoresis for palmar hyperhidrosis have been limited. Objective To determine the efficacy and safety of iontophoresis in the treatment of palmar hyperhidrosis with a randomized, sham-controlled, single-blind, and parallel-designed study. Methods Twenty nine pati...

  3. Meals based on vegetable protein sources (beans and peas) are more satiating than meals based on animal protein sources (veal and pork) – a randomized cross-over meal test study

    Science.gov (United States)

    Kristensen, Marlene D.; Bendsen, Nathalie T.; Christensen, Sheena M.; Astrup, Arne; Raben, Anne

    2016-01-01

    Background Recent nutrition recommendations advocate a reduction in protein from animal sources (pork, beef) because of environmental concerns. Instead, protein from vegetable sources (beans, peas) should be increased. However, little is known about the effect of these vegetable protein sources on appetite regulation. Objective To examine whether meals based on vegetable protein sources (beans/peas) are comparable to meals based on animal protein sources (veal/pork) regarding meal-induced appetite sensations. Design In total, 43 healthy, normal-weight, young men completed this randomized, double-blind, placebo-controlled, three-way, cross-over meal test. The meals (all 3.5 MJ, 28 energy-% (E%) fat) were either high protein based on veal and pork meat, HP-Meat (19 E% protein, 53 E% carbohydrate, 6 g fiber/100 g); high protein based on legumes (beans and peas), HP-Legume (19 E% protein, 53 E% carbohydrate, 25 g fiber/100 g); or low-protein based on legumes, LP-Legume (9 E% protein, 62 E% carbohydrate, 10 g fiber/100 g). Subjective appetite sensations were recorded at baseline and every half hour using visual analog scales until the ad libitum meal 3 h after the test meal. Repeated measurements analyses and summary analyses were performed using ANCOVA (SAS). Results HP-Legume induced lower composite appetite score, hunger, prospective food consumption, and higher fullness compared to HP-Meat and LP-Legume (pmeals (beans/peas) influenced appetite sensations favorably compared to animal-based meals (pork/veal) with similar energy and protein content, but lower fiber content. Interestingly, a vegetable-based meal with low protein content was as satiating and palatable as an animal-based meal with high protein content. PMID:27765144

  4. Arthroscopy or ultrasound in undergraduate anatomy education: a randomized cross-over controlled trial

    Science.gov (United States)

    2012-01-01

    Background The exponential growth of image-based diagnostic and minimally invasive interventions requires a detailed three-dimensional anatomical knowledge and increases the demand towards the undergraduate anatomical curriculum. This randomized controlled trial investigates whether musculoskeletal ultrasound (MSUS) or arthroscopic methods can increase the anatomical knowledge uptake. Methods Second-year medical students were randomly allocated to three groups. In addition to the compulsory dissection course, the ultrasound group (MSUS) was taught by eight, didactically and professionally trained, experienced student-teachers and the arthroscopy group (ASK) was taught by eight experienced physicians. The control group (CON) acquired the anatomical knowledge only via the dissection course. Exposure (MSUS and ASK) took place in two separate lessons (75 minutes each, shoulder and knee joint) and introduced standard scan planes using a 10-MHz ultrasound system as well as arthroscopy tutorials at a simulator combined with video tutorials. The theoretical anatomic learning outcomes were tested using a multiple-choice questionnaire (MCQ), and after cross-over an objective structured clinical examination (OSCE). Differences in student’s perceptions were evaluated using Likert scale-based items. Results The ASK-group (n = 70, age 23.4 (20–36) yrs.) performed moderately better in the anatomical MC exam in comparison to the MSUS-group (n = 84, age 24.2 (20–53) yrs.) and the CON-group (n = 88, 22.8 (20–33) yrs.; p = 0.019). After an additional arthroscopy teaching 1% of students failed the MC exam, in contrast to 10% in the MSUS- or CON-group, respectively. The benefit of the ASK module was limited to the shoulder area (p training is profitable and attractive to students with respect to complex joint anatomy. Simultaneous teaching of basic-skills in musculoskeletal ultrasound should be performed by medical experts, but seems to be inferior to the arthroscopic 2D-3D

  5. [Cortical blindness].

    Science.gov (United States)

    Chokron, S

    2014-02-01

    Cortical blindness refers to a visual loss induced by a bilateral occipital lesion. The very strong cooperation between psychophysics, cognitive psychology, neurophysiology and neuropsychology these latter twenty years as well as recent progress in cerebral imagery have led to a better understanding of neurovisual deficits, such as cortical blindness. It thus becomes possible now to propose an earlier diagnosis of cortical blindness as well as new perspectives for rehabilitation in children as well as in adults. On the other hand, studying complex neurovisual deficits, such as cortical blindness is a way to infer normal functioning of the visual system. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  6. Effect of almond consumption on vascular function in patients with coronary artery disease: a randomized, controlled, cross-over trial

    Science.gov (United States)

    Objective: Almonds reduce cardiovascular disease risk via cholesterol reduction, anti-inflammation, glucoregulation, and antioxidation. The objective of this randomized, controlled, cross-over trial was to determine whether the addition of 85 g almonds daily to a National Cholesterol Education Progr...

  7. Intravesical Capsaicin in Patients with Detrusor Hyper-reflexia. A Placebo-controlled Cross-over Study

    DEFF Research Database (Denmark)

    Petersen, T; Nielsen, J B; Schrøder, H D

    1999-01-01

    to anticholinergic treatment underwent intravesical administration of 50 ml 2% lignocaine. followed by either 100 ml 1 mmol/l capsaicin or 100 ml physiological saline for 30 min. Cross-over to the alternative treatment took place after 4 weeks. Varying degrees of burning sensation were experienced by all but one...

  8. 78 FR 58382 - Notice of Final Federal Agency Actions on the Proposed U.S. 50 Study Crossing Over Sinepauxent...

    Science.gov (United States)

    2013-09-23

    ... 5th Street to Somerset Street located in the Town of Ocean City, Worcester County, Maryland. This... on the Proposed U.S. 50 Study Crossing Over Sinepauxent Bay in the Town of Ocean City, Worcester County, Maryland AGENCY: Federal Highway Administration (FHWA), DOT. ACTION: Notice of limitation on...

  9. Platinum based doublet cross over therapy for advanced stage non small cell lung cancer? A better survival option

    Directory of Open Access Journals (Sweden)

    Rajiv Garg

    2012-01-01

    Full Text Available Platinum based doublet chemotherapy namely the cisplatin/carboplatin based etopiside or gemcitabine therapy forms the therapy of choice, for patients with advanced non small cell carcinoma of the lung. Here we report two cases were unusual cross over was done from gemcitabine-to cisplatin-doublet chemotherapy resulting in unexpectedly better clinical and radiological response.

  10. Orientation and Mobility with Persons Who Are Deaf-Blind: An Initial Examination of Single-Subject Design Research

    Science.gov (United States)

    Parker, Amy T.

    2009-01-01

    Persons who are deaf-blind represent a heterogeneous, low-incidence population of children and adults who, at some point in life, regardless of the presence of additional disabilities, may benefit from formal orientation and mobility (O&M) instruction. Current national policies, such as the No Child Left Behind Act, which emphasize that…

  11. Efficacy of low-frequency low-intensity electrotherapy in the treatment of breast cancer-related lymphoedema: a cross-over randomized trial.

    Science.gov (United States)

    Belmonte, Roser; Tejero, Marta; Ferrer, Montse; Muniesa, Josep Maria; Duarte, Esther; Cunillera, Oriol; Escalada, Ferran

    2012-07-01

    To compare the efficacy of low-frequency low-intensity electrotherapy and manual lymphatic drainage in the treatment of chronic upper limb breast cancer-related lymphoedema. Cross-over single-blind random clinical trial. Rehabilitation service. Thirty-six women with chronic upper limb breast cancer-related lymphoedema. Patients were randomized to undergo 10 sessions of manual lymphatic drainage followed by 10 sessions of low-frequency low-intensity electrotherapy or to undergo first low-frequency low-intensity electrotherapy followed by manual lymphatic drainage. There was a month of washout time between treatments. Each patient was examined just before and after each treatment. Researchers and outcome assessors were blinded for assigned treatment. Outcomes were lymphoedema volume, pain, heaviness and tightness, and health-related quality of life measured with the Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer version 4 (FACT-B+4). Carry-over, period and treatment effects were analysed. Treatment effect was assessed using paired t-test. Thirty patients finalized treatment. Comparing the changes in low-frequency low-intensity electrotherapy with manual lymphatic drainage changes, there were no significant differences. Low-frequency low-intensity electrotherapy did not reduce lymphoedema volume (mean of change = 19.77 mL, P = 0.36), but significant reductions were observed in pain, heaviness and tightness (mean of change = 13.1, 16.2 and 6.4 mm, respectively), and FACT-B+4 summaries improved significantly (Trial Outcome Index mean of change = 5.4, P = 0.015). Manual lymphatic drainage showed no significant changes in any of the outcomes Although there are no significant differences between treatment changes, the observed trend towards a better health-related quality of life is remarkable in low-frequency low-intensity electrotherapy.

  12. Cardiovascular Safety of Oral p-Synephrine (Bitter Orange) in Healthy Subjects: A Randomized Placebo-Controlled Cross-over Clinical Trial.

    Science.gov (United States)

    Shara, Mohd; Stohs, Sidney J; Mukattash, Tareq L

    2016-05-01

    Bitter orange (Citrus aurantium) extract and its primary protoalkaloid p-synephrine are widely consumed in combination with multiple herbal ingredients for weight management and sports performance. p-Synephrine is also present in juices and foods derived from a variety of Citrus species. Questions exist regarding the safety of p-synephrine because of structural similarities with other biogenic amines. This study assessed the cardiovascular (stimulatory) effects of bitter orange extract (49-mg p-synephrine) given to 18 healthy subjects (nine men and nine women) in a double-blinded, placebo-controlled cross-over study. Heart rates, blood pressures, and electrocardiograms were determined at baseline, 30, 60, 90 min, 2, 4 , 6, and 8 h. Blood samples were drawn at baseline, 2 h and 8 h for serum chemistries, blood cell counts, and p-synephrine and caffeine levels. No significant changes occurred in electrocardiograms, heart rates, systolic blood pressure, blood chemistries, or blood cell counts at any time point in either control or p-synephrine treated group. A small (4.5 mmHg) decrease in diastolic blood pressure occurred in the p-synephrine treated group at 60 min. No adverse effects were reported. Caffeine ingestion varied markedly among the participants. p-Synephrine does not act as a stimulant at the dose used. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  13. The effect of recommending a CPP-ACPF product on salivary and plaque pH levels in orthodontic patients: a randomized cross-over clinical trial.

    Science.gov (United States)

    Heshmat, Haleh; Banava, Sepideh; Mohammadi, Ebrahim; Kharazifard, Mohammad Javad; Mojtahedzadeh, Faramarz

    2014-11-01

    Along with their re-mineralizing capacity, calcium phosphopeptide-amorphous calcium phosphate products combined with fluoride (CPP-ACPF) could also be beneficial by neutralizing acidic salivary and plaque pH. The purpose was to evaluate the effect of CPP-ACPF on salivary and plaque pH in orthodontic patients. As a triple-blind, cross-over randomized trial, 30 orthodontic patients with fixed appliances (age range = 15.70 ± 4.08 years) were recruited and randomly assigned to two groups. A CPP-ACPF paste (MI Paste Plus, GC America, Alsip, IL) was used by group 1 (n = 15) and a placebo by group 2 (n = 15) for 1 month. After a 1 month washout period, patients used the alternative paste for another month. Plaque and salivary pH levels were measured at all before and after periods. By applying MI Paste Plus, the plaque pH increased from 5.81 ± 0.45 to 6.60 ± 0.38 (p pH recordings, which were 6.72 ± 0.43 and 6.71 ± 0.38, respectively, remained statistically unchanged (p > 0.05). MI Paste Plus can be clinically beneficial in increasing plaque pH levels, but has no effect on the salivary pH.

  14. Consumption of organic diets does not affect intake and absorption of zinc and copper in men-evidence from two cross-over trials

    DEFF Research Database (Denmark)

    Mark, Alicja Budek; Kápolna, Emese; Laursen, Kristian H.

    2013-01-01

    diets on intake and absorption of zinc and copper in men. Two double-blinded, cross-over, intervention trials (3 dietary periods of 12 days with 2-week-long wash-out) were performed in 2008 (n = 17) and 2009 (n = 16) in young men. The diets were based on 9 crops grown in rigidly controlled organic......Agricultural methods may affect the nutritional composition of plants and cause complex changes in the food matrix. Whether this affects the dietary absorption of minerals that are important for maintaining health thorough life remains unclear. We compared the effects of organic and conventional......; 12.35 ± 0.47 mg per 10 MJ and 44.6% ± 12.1, respectively) and copper (overall mean ± SD; 2.12 ± 0.28 mg per 10 MJ and 41.2% ± 13.2, respectively) were not different between the organic and conventional diets. The growing season had no effect on zinc intake and absorption, but the copper intake...

  15. The Impact of a Single Dose of a Polyphenol-Rich Seaweed Extract on Postprandial Glycaemic Control in Healthy Adults: A Randomised Cross-Over Trial

    Directory of Open Access Journals (Sweden)

    Margaret Murray

    2018-02-01

    Full Text Available This study investigated the impact of a polyphenol-rich seaweed extract on postprandial glycaemia in healthy adults, and, as a secondary outcome, the influence of ethnicity on these outcomes. Thirty-eight volunteers (26 non-Asian, 12 Asian aged 19 to 56 years participated in this double-blind, placebo-controlled, randomised cross-over trial. Participants each consumed a low (500 mg, and high (2000 mg dose of the polyphenol-rich brown seaweed (Fucus vesiculosus extract, as well as a cellulose placebo (2000 mg, 30 min prior to 50 g of available carbohydrate from white bread. Postprandial blood glucose and plasma insulin concentrations were measured over two hours (fasting, 15, 30, 45, 60, 90, and 120 min from a finger prick blood sample. Data were analysed using a repeated measures analysis of variance. Compared with the placebo, neither dose had a lowering effect on postprandial glucose or insulin responses. However, individuals of an Asian background experienced consistently elevated plasma insulin responses, assessed using an incremental area under the curve, compared with non-Asian participants, irrespective of supplement (p = 0.016. These results suggest an increased risk of insulin resistance among Asian populations, compared with non-Asian, and that measurement of blood glucose levels alone may be insufficient to diagnose diabetes risk in this population.

  16. External chest compressions using a mechanical feedback device : cross-over simulation study.

    Science.gov (United States)

    Skorning, M; Derwall, M; Brokmann, J C; Rörtgen, D; Bergrath, S; Pflipsen, J; Beuerlein, S; Rossaint, R; Beckers, S K

    2011-08-01

    External chest compressions (ECC) are essential components of resuscitation and are usually performed without any adjuncts in professional healthcare. Even for healthcare professionals during in-hospital and out-of-hospital resuscitation poor performance in ECC has been reported in recent years. Although several stand-alone devices have been developed none has been implemented as a standard in patient care. The aim of this study was to examine if the use of a mechanical device providing visual feedback and audible assistance during ECC improves performance of healthcare professionals following minimal and simplified instructions. In a prospective, randomized cross-over study 81 healthcare professionals performed ECC for 3 min (in the assumed setting of a secured airway) twice on a manikin (Skillreporter ResusciAnne®, with PC-Skillreporting System Version 1.3.0, Laerdal, Stavanger, Norway) in a mock cardiac arrest scenario. Group 1 (n=40) performed ECC with the device first followed by classic ECC and group 2 (n=41) in the opposite order. Minimal instructions were standardized and provided by video instruction (1 min 38 s). Endpoints were achievement of a mean compression rate between 90 and 110/min and a mean compression depth of 40-50 mm. In addition participants had to answer questionnaires about demographic data, professional experience and recent recommendations for ECC as well as their impression of the device concerning the ease of use and their personal level of confidence. Data were analyzed for group-related and inter-group differences using SAS (Version 9.1.3, SAS Institute, Cary, NC). A total of 81 healthcare professionals regularly involved in resuscitation attempts in pre-hospital or in-hospital settings took part in the study with no differences between the groups: females 35.8% (n=52), emergency medical technicians 32.1% (n=26), anesthesia nurses 32.1% (n=26), physicians (anesthesiology) 45% (n=29). In group 1 33 out of 40 (82.5%; 99.7±4

  17. A randomized cross-over trial of the postprandial effects of three different diets in patients with type 2 diabetes.

    Directory of Open Access Journals (Sweden)

    Hanna Fernemark

    Full Text Available In the clinic setting both fasting levels of glucose and the area under the curve (AUC of glucose, by determination of HbA1c levels, are used for risk assessments, in type 2 diabetes (NIDDM. However little is known about postprandial levels, and hence AUC, regarding other traditional risk factors such as insulin and blood-lipids and how this is affected by different diets.To study postprandial effects of three diets, during a single day, in NIDDM.A low-fat diet (45-56 energy-% from carbohydrates, and a low-carbohydrate diet (16-24 energy-% from carbohydrates was compared with a Mediterranean-style diet (black coffee for breakfast and the same total-caloric intake as the other two diets for lunch with red wine, 32-35 energy-% from carbohydrates in a randomized cross-over design. Total-caloric intake/test-day at the clinic from food was 1025-1080 kCal in men and 905-984 kCal in women. The test meals were consumed at a diabetes ward under supervision.Twenty-one participants were recruited and 19 completed the studies. The low-carbohydrate diet induced lower insulin and glucose excursions compared with the low-fat diet (p<0.0005 for both AUC. The insulin-response following the single Mediterranean-style lunch-meal was more pronounced than during the low-fat diet lunch (insulin increase-ratio of the low-fat diet: 4.35 ± 2.2, of Mediterranean-style diet: 8.12 ± 5.2, p = 0.001 while postprandial glucose levels were similar. The increase-ratio of insulin correlated with the elevation of the incretin glucose-dependent insulinotropic-polypeptide following the Mediterranean-style diet lunch (Spearman, r = 0.64, p = 0.003.The large Mediterranean-style lunch-meal induced similar postprandial glucose-elevations as the low-fat meal despite almost double amount of calories due to a pronounced insulin-increase. This suggests that accumulation of caloric intake from breakfast and lunch to a single large Mediterranean style lunch-meal in NIDDM might

  18. A Randomized Cross-Over Trial of the Postprandial Effects of Three Different Diets in Patients with Type 2 Diabetes

    Science.gov (United States)

    Bunjaku, Bekim; Rosenqvist, Ulf; Nystrom, Fredrik H.; Guldbrand, Hans

    2013-01-01

    Background In the clinic setting both fasting levels of glucose and the area under the curve (AUC) of glucose, by determination of HbA1c levels, are used for risk assessments, in type 2 diabetes (NIDDM). However little is known about postprandial levels, and hence AUC, regarding other traditional risk factors such as insulin and blood-lipids and how this is affected by different diets. Objective To study postprandial effects of three diets, during a single day, in NIDDM. Methods A low-fat diet (45–56 energy-% from carbohydrates), and a low-carbohydrate diet (16–24 energy-% from carbohydrates) was compared with a Mediterranean-style diet (black coffee for breakfast and the same total-caloric intake as the other two diets for lunch with red wine, 32–35 energy−% from carbohydrates) in a randomized cross-over design. Total-caloric intake/test-day at the clinic from food was 1025–1080 kCal in men and 905–984 kCal in women. The test meals were consumed at a diabetes ward under supervision. Results Twenty-one participants were recruited and 19 completed the studies. The low-carbohydrate diet induced lower insulin and glucose excursions compared with the low-fat diet (pdiet lunch (insulin increase-ratio of the low-fat diet: 4.35±2.2, of Mediterranean-style diet: 8.12±5.2, p = 0.001) while postprandial glucose levels were similar. The increase-ratio of insulin correlated with the elevation of the incretin glucose-dependent insulinotropic-polypeptide following the Mediterranean-style diet lunch (Spearman, r = 0.64, p = 0.003). Conclusions The large Mediterranean-style lunch-meal induced similar postprandial glucose-elevations as the low-fat meal despite almost double amount of calories due to a pronounced insulin-increase. This suggests that accumulation of caloric intake from breakfast and lunch to a single large Mediterranean style lunch-meal in NIDDM might be advantageous from a metabolic perspective. Trial Registration ClinicalTrials.gov NCT

  19. Feasibility demonstration of booster cross-over system for 3 1/2 inch SRB/MLP frangible nut system

    Science.gov (United States)

    1983-01-01

    Recent testing of the SRB/MLP Frangible Nut System (SOS Part Number 114850-9/Boosters P/N 114848-3) at NASA indicated a need to reduce the function time between boosters (2) within a single frangible nut. These boosters are initiated separately by electrical impulse(s). Coupling the output of each detonator with an explosive cross-over would reduce the function time between boosters (independent of electrical impulse) while providing additional redundancy to the system. The objectives of this program were to: provide an explosive cross-over between boosters, reduce function time between boosters to less than one (1) millisecond within a given nut, reduce cost of boosters, be compatible with the existing frangible nut system, and meet requirements of USBI Spec's (nut 10SPC-0030, booster 10SPC-0031).

  20. Global Postural Reeducation in patients with chronic nonspecific neck pain: cross-over analysis of a randomized controlled trial.

    Science.gov (United States)

    Pillastrini, Paolo; Banchelli, Federico; Guccione, Andrew; Di Ciaccio, Emanuele; Violante, Francesco Saverio; Brugnettini, Monia; Vanti, Carla

    2018-02-01

    To compare the effects of Global Postural Reeducation (GPR) with Manual Therapy (MT) in participants with chronic nonspecific neck pain (NP). Pre- and post-treatment analysis of cross-over data from an RCT was done. Seventy-eight subjects with chronic nonspecific NP aged 18 to 80 years completed the trial. The group who had received GPR crossed-over to MT and the previous MT group received GPR for 9 sessions once or twice a week. Measures were assessed at pre-treatment and post-treatment. Outcome measures included pain intensity [Visual Analogue Scale (VAS)], disability (Neck Disability Index), cervical Range of Motion (ROM), and kinesiophobia [Tampa Scale of Kinesiophobia (TSK)]. GPR targeted to crossed-over participants produced greater improvements in pain [Diff=-8.6; 95%CI=(-13.3; -3.8)], disability [Diff=-1.5; 95%CI=-2.8; -0.1], kinesiophobia [Diff=-1.8; 95%CI=(-3.2; -0.3)], and flexion/extension neck ROM [Diff=5.6; 95%CI=(1.8; 9.3)] at post-treatment compared to the MT group. When evaluating clinical improvement, by means of Minimal Clinically Important Differences, we found that GPR relevantly reduced neck disability with respect to MT [OR=2.13; 95% CI=(1.05; 4.35)], whereas the improvement of pain did not differ between groups [OR=1.84; 95%CI=0.85; 3.99)]. These results within the crossed-over group confirm previous findings from an RCT with the same sample. Sequence of treatment (GPR-to-MT vs MT-to-GPR) does not seem to weaken the greater effects of GPR compared to MT approach for chronic NP. Our findings suggest that GPR can induce hypoalgesic effects, reduce disability and kinesiophobia, and improve flexion/extension in neck ROM.

  1. [Molecular analysis of crossing-over in the CMH in two Tunisian families with aplastic bone marrow].

    Science.gov (United States)

    Lahiani, N Mahfoudh; Kamoun, A; Bellaaj, H; Elloumi, M; Souissi, T; Makni, H

    2009-07-01

    In order to select compatible human leucocytes antigens (HLA) donors for bone marrow graft, all the members of 76 families were typed by serology for HLA class I (A and B locus) and class II (DR, DQ locus) by polymerase chain-reaction-sequence-specific primes (PCR-SSP). The HLA typing interpretation revealed the existence of crossing-over in major histocompatibility (CMH) regions for two families, AB and AT, with aplastic bone marrow. The study of crossing-over site has needed the genotyping of seven short tandem repeat (STR) markers located on the short arm of chromosome 6 (D6S291, D6S273, TNFa, C1.2.C, C3.2.11, D6S265, D6S276), using ABI Prism 310 sequencer. HLA and STR Haplotypic analysis enabled us to confirm the crossing-over between locus B and DR in AB family and between locus A and B in AT family. Based in this study, we recommend to be careful in the interpretation of the results of HLA typing between donors and recipients of bone marrow. Complementary investigations should be accomplished for studying genetic abnormalities, which would be involved in this pathology.

  2. The effect of physical training on patients with rheumatoid arthritis: changes in disease activity, muscle strength and aerobic capacity. A clinically controlled minimized cross-over study

    DEFF Research Database (Denmark)

    Lyngberg, K; Danneskiold-Samsøe, B; Halskov, O

    1988-01-01

    For decades, physical training of rheumatoid arthritis (RA)-patients has been controversial, especially for patients with active disease. The aim of this study was to investigate whether RA-patients could receive graduated training without increasing the activity of the disease. In a controlled...... cross-over study the effect of graduated progressive training has been evaluated in 18 RA-patients with moderately active disease. The training was performed twice weekly with aerobic conditioning and strength exercises progressing to strenuous exercises over an 8-week period. The design was a crossover...... project with two groups obtained by minimisation. After training the patients had significantly fewer swollen joints than before. Training of the muscles acting over the swollen joints resulted in more than a 35% decrease in the number of swollen joints. The hemoglobin level increased significantly after...

  3. Randomized cross-over study of patient preference for oral or intravenous vinorelbine in combination with carboplatin in the treatment of advanced NSCLC

    DEFF Research Database (Denmark)

    Jensen, Lisa Helene Toft; Østerlind, Kell Erik; Rytter, C.

    2008-01-01

    BACKGROUND: Most chemotherapeutics are administrated intravenously (iv), but some are also available in an oral (po) formulation. This study was designed with the primary objective to estimate the patients' preference for po or iv vinorelbine in combination with carboplatin for the palliative...... treatment of non-small cell lung cancer (NSCLC). Secondary aims were to evaluate toxicity, efficacy, and subjective reasons the preference. PATIENTS AND METHODS: Sixty-one patients were randomized in a cross-over trial to two cycles of carboplatin day 1 and vinorelbine day 1 and day 8 iv followed by two...... cycles of carboplatin and vinorelbine po, or the opposite. Patients, who did not show progressive disease after four cycles, had a free choice of iv or po vinorelbine for the next two cycles. RESULTS: Forty-three patients were evaluable for preference and 32 (74%, 95% CI 61-88%) chose po (p

  4. The Effect of Aromatherapy Abdominal Massage on Alleviating Menstrual Pain in Nursing Students: A Prospective Randomized Cross-Over Study

    Directory of Open Access Journals (Sweden)

    Tyseer M. F. Marzouk

    2013-01-01

    Full Text Available Dysmenorrhea is a common cause of sickness absenteeism from both classes and work. This study investigated the effect of aromatherapy massage on a group of nursing students who are suffering of primary dysmenorrhea. A randomized blind clinical trial of crossover design was used. In the first treatment phase, group 1 ( received aromatherapy abdominal massage once daily for seven days prior to menstruation using the essential oils (cinnamon, clove, rose, and lavender in a base of almond oil. Group 2 ( received the same intervention but with placebo oil (almond oil. In the second treatment phase, the two groups switched to alternate regimen. Level and duration of pain and the amount of menstrual bleeding were evaluated at the baseline and after each treatment phase. During both treatment phases, the level and duration of menstrual pain and the amount of menstrual bleeding were significantly lower in the aromatherapy group than in the placebo group. These results suggests that aromatherapy is effective in alleviating menstrual pain, its duration and excessive menstrual bleeding. Aromatherapy can be provided as a nonpharmacological pain relief measure and as a part of nursing care given to girls suffering of dysmenorrhea, or excessive menstrual bleeding.

  5. The Effect of Aromatherapy Abdominal Massage on Alleviating Menstrual Pain in Nursing Students: A Prospective Randomized Cross-Over Study

    Science.gov (United States)

    Marzouk, Tyseer M. F.; El-Nemer, Amina M. R.; Baraka, Hany N.

    2013-01-01

    Dysmenorrhea is a common cause of sickness absenteeism from both classes and work. This study investigated the effect of aromatherapy massage on a group of nursing students who are suffering of primary dysmenorrhea. A randomized blind clinical trial of crossover design was used. In the first treatment phase, group 1 (n = 48) received aromatherapy abdominal massage once daily for seven days prior to menstruation using the essential oils (cinnamon, clove, rose, and lavender in a base of almond oil). Group 2 (n = 47) received the same intervention but with placebo oil (almond oil). In the second treatment phase, the two groups switched to alternate regimen. Level and duration of pain and the amount of menstrual bleeding were evaluated at the baseline and after each treatment phase. During both treatment phases, the level and duration of menstrual pain and the amount of menstrual bleeding were significantly lower in the aromatherapy group than in the placebo group. These results suggests that aromatherapy is effective in alleviating menstrual pain, its duration and excessive menstrual bleeding. Aromatherapy can be provided as a nonpharmacological pain relief measure and as a part of nursing care given to girls suffering of dysmenorrhea, or excessive menstrual bleeding. PMID:23662151

  6. Effect of 4 weeks of octreotide treatment on prolactin, thyroid stimulating hormone and thyroid hormones in acromegalic patients. A double blind placebo-controlled cross-over study

    DEFF Research Database (Denmark)

    Andersen, M; Hansen, T B; Bollerslev, J

    1995-01-01

    We aimed to test the hypothesis, that octreotide has a suppressive effect on unstimulated and TRH-stimulated PRL levels in both normo- and hyperprolactinaemic acromegalic patients, and besides to evaluate the effect of octreotide on unstimulated TSH and thyroid hormones. The present study is a do...

  7. Medium-dose riboflavin as a prophylactic agent in children with migraine: A preliminary placebo-controlled, randomised, double-blind, cross-over trial

    NARCIS (Netherlands)

    J.K.J. Bruijn (Jacques); H.J. Duivenvoorden (Hugo); J. Passchier (Jan); H. Locher (Heiko); N. Dijkstra (Natascha); W.F.M. Arts (Willem Frans)

    2010-01-01

    textabstractBackground: Riboflavin seems to have a promising effect on migraine in adults. The present study examines whether riboflavin has a prophylactic effect on migraine in children. Objective: To investigate whether riboflavin in a dosage of 50 mg/day has a prophylactic effect on migraine

  8. Deep soft-tissue massage applied to healthy calf muscle has no effect on passive mechanical properties: a randomized, single-blind, cross-over study.

    Science.gov (United States)

    Thomson, Daniel; Gupta, Amitabh; Arundell, Jesica; Crosbie, Jack

    2015-01-01

    Massage is often applied with the intention of improving flexibility or reducing stiffness in musculotendinous tissue. There is, however, a lack of supporting evidence that such mechanical effects occur. The purpose of the study was to investigate the effect of massage on the passive mechanical properties of the calf muscle complex. Twenty nine healthy volunteers aged between 18 and 45 years of age had their calf muscle compliance and ankle joint dorsiflexion range of motion (ROM) measured using an instrumented footplate before, immediately and 30 minutes after a ten minute application of deep massage or superficial heating to the calf muscle complex. Repeated measures analysis of variance was used to determine differences between testing sessions and the types of intervention. Reliability testing for the measurement method was conducted using analysis of variance both within and between testing sessions. There was no significant change in calf muscle stiffness or ankle dorsiflexion range of motion with or without the application of calf massage. Inter- and intra-session reliability were very high, ICC > 0.88 (p calf muscle complex. The findings of this study suggest that the use of massage to increase tissue flexibility prior to activity is not justified.

  9. Comparison of the urinary excretion of quercetin glycosides from red onion and aglycone from dietary supplements in healthy subjects: a randomized, single-blinded, cross-over study.

    Science.gov (United States)

    Shi, Yuanlu; Williamson, Gary

    2015-05-01

    Some intervention studies have shown that quercetin supplementation can regulate certain biomarkers, but it is not clear how the doses given relate to dietary quercetin (e.g. from onion). We conducted a two-period, two-sequence crossover study to compare the bioavailability of quercetin when administered in the form of a fresh red onion meal (naturally glycosylated quercetin) or dietary supplement (aglycone quercetin) under fasting conditions. Six healthy, non-smoking, adult males with BMI 22.7 ± 4.0 kg m(-2) and age 35.3 ± 12.3 y were grouped to take the two study meals in random order. In each of the 2 study periods, one serving of onion soup (made from 100 g fresh red onion, providing 156.3 ± 3.4 μmol (47 mg) quercetin) or a single dose of a quercetin dihydrate tablet (1800 ± 150 μmol (544 mg) of quercetin) were administered following 3 d washout. Urine samples were collected up to 24 h, and after enzyme deconjugation, quercetin was quantified by LC-MS. The 24 h urinary excretion of quercetin (1.69 ± 0.79 μmol) from red onion in soup was not significantly different to that (1.17 ± 0.44 μmol) for the quercetin supplement tablet (P = 0.065, paired t-test). This means that, in practice, 166 mg of quercetin supplement would be comparable to about 10 mg of quercetin aglycone equivalents from onion. These data allow intervention studies on quercetin giving either food or supplements to be more effectively compared.

  10. Double-blind, placebo-controlled cross-over study of intravenous S-adenosyl-L-methionine in patients with fibromyalgia

    DEFF Research Database (Denmark)

    Volkmann, H; Nørregaard, J; Jacobsen, Søren

    1997-01-01

    . There was no significant difference in improvement in the primary outcome: tender point change between the two treatment groups. There was a tendency towards statistical significance in favour of SAMe on subjective perception of pain at rest (p = 0.08), pain on movement (p = 0.11), and overall well-being (p = 0.......17) and slight improvement only on fatigue, quality of sleep, morning stiffness, and on the Fibromyalgia Impact Questionnaire for pain. No effect could be observed on isokinetic muscle strength, Zerrsen self-assessment questionnaire, and the face scale. No effect of SAMe in patients with FM was found...

  11. A double-blind placebo-controlled cross-over study of the vascular effects of midodrine in neuropathic compared with hyperadrenergic postural tachycardia syndrome

    OpenAIRE

    ROSS, Amanda J.; OCON, Anthony J.; MEDOW, Marvin S.; STEWART, Julian M.

    2014-01-01

    POTS (postural tachycardia syndrome) is a chronic form of OI (orthostatic intolerance). Neuropathic POTS is characterized by decreased adrenergic vasoconstriction, whereas hyperadrenergic POTS exhibits increased adrenergic vasoconstriction. We hypothesized that midodrine, an α1-adrenergic receptor agonist, would increase CVR (calf vascular resistance), decrease Cv (calf venous capacitance) and decrease orthostatic tachycardia in neuropathic POTS, but not alter haemodynamics in hyperadrenergic...

  12. A yeast strain for simultaneous detection of induced mitotic crossing over, mitotic gene conversion and reverse mutation

    International Nuclear Information System (INIS)

    Zimmermann, F.K.; Kern, R.; Rasenberger, H.

    1975-01-01

    A diploid yeast strain of Saccharomyces cerevisiae is described which can be used to study induction of mitotic crossing-over, mitotic gene conversion and reverse mutation. Mitotic crossing-over can be detected visually as pink and red twin-sectored colonies which are due to the formation of homozygous cells of the genotype ade2-40/ade2-40 (deep red) and ade-2-119/ade2-119 (pink) from the originally heteroallelic condition ade2-40/ade2-119 which forms white colonies. Mitotic gene conversion is monitored by the appearance of tryptophan nonrequiring colonies on selective media. The alleles involved are trp5-12 and trp5-27 derived from the widely used strain D 4 . Mutation induction can be followed by the appearance of isoleucine nonrequiring colonies on selective media. D 7 is homoallelic ilvI-92. The isoleucine requirement caused by ilvI-92 can be alleviated by true reverse mutation and allele non-specific suppressor mutation. The effects of ethyl methanesulfonate (EMS), nitrous acid, ultraviolet light and hycanthone methanesulfonate were studied with D 7 stationary phase cells. Mitotic crossing-over as monitored by red/pink twin-sectored colonies was almost equally frequent among normal and convertant cells. This showed again that nitotic recombination is not due to the presence of a few cells committed to meiosis in an otherwise mitotic cell population. The dose-response curves for induction of mitotic gene conversion and reversion of the isoleucine requirement were exponential. In contrast to this, the dose-response curve for induction of twin sectored red and pink colonies reached a plateau at doses giving about 30% cell killing. This could partly be due to lethal segregation in the progeny of treated cells. None of the agents tested would induce only one type of mitotic recombination, gene conversion or crossing-over. There was, however, some mutagen specificity in the induction of isoleucine prototrophs

  13. Efficacy of omeprazole on cough, pulmonary function and quality of life of patients with sulfur mustard lung injury: A placebo-control, cross-over clinical trial study

    Directory of Open Access Journals (Sweden)

    Mohammad Hossein Emami

    2014-01-01

    Full Text Available Background: Gastro-esophageal reflux disease (GERD is prevalent and related to more severe disease in patients with respiratory problems. We evaluated the effects of antireflux therapy in warfare victims of exposure to Mustard gas with chronic cough. Materials and Methods: This randomized, double-blind, placebo-controlled, cross-over study was conducted on 45 cases of sulfur mustard injury with chronic cough (≥8 weeks and GERD. Patients were randomized into two groups, receiving either 20 mg twice daily omeprazole-placebo (OP or matching placebo (placebo-omeprazole [PO] for 4 months, followed by a 1-month washout period and the alternative treatment for 4 months. Assessments included GERD and cough, quality of life, and pulmonary function using spirometry. Leicester Cough Questionnaire and SF-36 were used for measuring quality of life. Results: Patients in the OP group experienced a more decrease than those in the PO group in severity of Leicester cough scores during the first 4-month of trial. After crossing the groups, the OP group experienced an increase (P = 0.036 and the PO group experienced a nonsignificant decrease (P = 0.104 in the severity of scores. The OP group also experienced improvement in GERD symptoms and quality of life at the end of the trial, but changes in the PO group was not significant. There was no significant change in respiratory function indices in any groups. Conclusion: Long-term treatment with high-dose omeprazole improved GERD as well as cough, and quality of life, but not changed respiratory function indices in sulfur mustard injured cases with respiratory symptoms.

  14. The Pakistan national blindness and visual impairment survey--research design, eye examination methodology and results of the pilot study.

    Science.gov (United States)

    Bourne, Rupert; Dineen, Brendan; Jadoon, Zahid; Lee, Pak S; Khan, Aman; Johnson, Gordon J; Foster, Allen; Khan, Daud

    2005-10-01

    To establish age- and sex-specific prevalence rates and causes of blindness and low vision in children aged 10 to 15 years and adults aged 30 years and older in Pakistan. Multi-stage, stratified (rural/urban), cluster random sampling, with probability proportional-to-size procedures, was utilised to select a cross-sectional, nationally representative sample of adults (16,600 subjects) and children (6,000 subjects). Each subject underwent: interview, visual acuity (logMAR), autorefraction and optic disc examination. Those that saw visual acuity and dilated posterior segment examination. The results of a pilot survey are reported in this paper. In the two rural pilot sites, 159 subjects (including 47 children) were examined; 50% were male. Thirty seven adults (23.3%) but no children saw worse than 6/12 in either eye. Two subjects were blind (corrected visual acuity) in the better eye, and 11 were visually impaired. Refractive error was the main cause (in 22 eyes (39% of the total of 56 eyes)) of visual acuity, followed by cataract (12 eyes), uncorrected aphakia (6 eyes) and age-related macular disease (3 eyes). The pilot survey demonstrated that the proposed examination process for the main survey is feasible. Particular strengths of this survey include the use of logMAR visual acuity testing and autorefraction of all subjects, a dilated posterior segment examination, and the use of a 'less than 6/12' threshold for further examination. This lower threshold addresses the burden of refractive error, which, with cataract, are two of the diseases specifically targeted by Vision 2020.

  15. Different test systems in Aspergillus nidulans for the evaluation of mitotic gene conversion, crossing-over and non-disjunction

    International Nuclear Information System (INIS)

    De Bertoldi, M.; Griselli, M.; Consiglio Nazionale delle Ricerche, Pisa; Barale, R.

    1980-01-01

    The wide variety of the genetic alterations produced by environmental mutagens has increased the necessity of using experimental microorganisms to reveal the induction of such genetic events with short-term tests. Aspergillus nidulans, because of its well-developed genetic system and the availability of morphological markers seay to score, can be profitably used in mutagen testing. The constitution of particular diploid strains of A. nidulans able to detect the induction of mitotic gene conversion, mitotic crossing-over and mitotic non-disjunction with selective procedures are described and validated with standard mutagens: methyl methanesulphonate and UV radiation (lacking a specific genetic activity), benomyl and p-fluorophenylalanine (with a specific genetic activity). The possibility of using mammalian metabolic activation of promutagens in A. nidulans in vitro was tested with cyclophosphamide, with positive results in all the tested genetic systems. A method that increases the sensitivity of conidia to mutagenic treatments is described; its application appeared to be particularly useful in experiments on crossing-over and non-disjunction. (orig.)

  16. The effect of methanol and ethanol cross-over on the performance of PtRu/C-based anode DAFCs

    Energy Technology Data Exchange (ETDEWEB)

    Song, Shuqin; Zhou, Weijiang; Liang, Zhenxing; Sun, Gongquan; Xin, Qin [Direct Alcohol Fuel Cell Laboratory, Dalian Institute of Chemical Physics, CAS, P. O. Box 110, 116023 Dalian (China); Cai, Rui [State Key Laboratory of Catalysis, Dalian Institute of Chemical Physics, CAS, P. O. Box 110, 116023 Dalian (China); Stergiopoulos, Vaios; Tsiakaras, Panagiotis [Department of Mechanical and Industrial Engineering, School of Engineering, University of Thessalia, Pedion Areos, 383 34 Volos (Greece)

    2005-01-10

    In the present work, the cross-over rates of methanol and ethanol, respectively, through Nafion{sup (R)}-115 membranes at different temperatures and different concentrations have been measured and compared. The changes of Nafion{sup (R)}-115 membrane porosity in the presence of methanol or ethanol aqueous solutions were also determined by weighing vacuum-dried and alcohol solution-equilibrated membranes. The techniques of anode polarization and adsorption stripping voltammetry were applied to compare the electrochemical activity and adsorption ability, respectively. To investigate the consequences of methanol and ethanol permeation from the anode to the cathode on the performance of direct alcohol fuel cells (DAFCs), single DAFC tests, with methanol or ethanol as the fuel, have been carried out and the corresponding anode and cathode polarizations versus dynamic hydrogen electrode (DHE) were also performed. The effect of alcohol concentration on the performance of PtRu/C anode-based DAFCs was investigated. It was found that ethanol shows lower cross-over rates than methanol through the Nafion{sup (R)} membrane in spite of the higher membrane porosity resulted in presence of ethanol aqueous solutions. Furthermore, it was found that ethanol presents less negative effect on the cathode performance due to both its smaller permeability through Nafion{sup (R)} membrane and its slower electrochemical oxidation kinetics over Pt/C cathode.

  17. Meals based on vegetable protein sources (beans and peas are more satiating than meals based on animal protein sources (veal and pork – a randomized cross-over meal test study

    Directory of Open Access Journals (Sweden)

    Marlene D. Kristensen

    2016-10-01

    Full Text Available Background: Recent nutrition recommendations advocate a reduction in protein from animal sources (pork, beef because of environmental concerns. Instead, protein from vegetable sources (beans, peas should be increased. However, little is known about the effect of these vegetable protein sources on appetite regulation. Objective: To examine whether meals based on vegetable protein sources (beans/peas are comparable to meals based on animal protein sources (veal/pork regarding meal-induced appetite sensations. Design: In total, 43 healthy, normal-weight, young men completed this randomized, double-blind, placebo-controlled, three-way, cross-over meal test. The meals (all 3.5 MJ, 28 energy-% (E% fat were either high protein based on veal and pork meat, HP-Meat (19 E% protein, 53 E% carbohydrate, 6 g fiber/100 g; high protein based on legumes (beans and peas, HP-Legume (19 E% protein, 53 E% carbohydrate, 25 g fiber/100 g; or low-protein based on legumes, LP-Legume (9 E% protein, 62 E% carbohydrate, 10 g fiber/100 g. Subjective appetite sensations were recorded at baseline and every half hour using visual analog scales until the ad libitum meal 3 h after the test meal. Repeated measurements analyses and summary analyses were performed using ANCOVA (SAS. Results: HP-Legume induced lower composite appetite score, hunger, prospective food consumption, and higher fullness compared to HP-Meat and LP-Legume (p<0.05. Furthermore, satiety was higher after HP-Legume than HP-Meat (p<0.05. When adjusting for palatability, HP-Legume still resulted in lower composite appetite scores, hunger, prospective consumption, and higher fullness compared to HP-Meat (p<0.05. Furthermore, HP-Legume induced higher fullness than LP-Legume (p<0.05. A 12% and 13% lower energy intake, respectively, was seen after HP-Legume compared to HP-Meat or LP-Legume (p<0.01. Conclusion: Vegetable-based meals (beans/peas influenced appetite sensations favorably compared to animal-based meals

  18. Meals based on vegetable protein sources (beans and peas) are more satiating than meals based on animal protein sources (veal and pork) - a randomized cross-over meal test study

    DEFF Research Database (Denmark)

    Kristensen, Marlene Dahlwad; Bendsen, Nathalie Tommerup; Christensen, Sheena M

    2016-01-01

    -blind, placebo-controlled, three-way, cross-over meal test. The meals (all 3.5 MJ, 28 energy-% (E%) fat) were either high protein based on veal and pork meat, HP-Meat (19 E% protein, 53 E% carbohydrate, 6 g fiber/100 g); high protein based on legumes (beans and peas), HP-Legume (19 E% protein, 53 E% carbohydrate...... and summary analyses were performed using ANCOVA (SAS). RESULTS: HP-Legume induced lower composite appetite score, hunger, prospective food consumption, and higher fullness compared to HP-Meat and LP-Legume (pMeat (p... for palatability, HP-Legume still resulted in lower composite appetite scores, hunger, prospective consumption, and higher fullness compared to HP-Meat (p

  19. Cross-over

    DEFF Research Database (Denmark)

    Mørck, Line Lerche; Christensen, Tina Wilchen

    ”Cross-over” er en kategori, der dækker over bevægelser mellem kriminalitet og bandetilhør til politisk og religiøs ekstremisme. Den er opstået i kølvandet på Omar El-Husseins terrorangreb i København foråret 2015. Kategorien refererer til en bestemt type bevægelse og kan derved medvirke til at s...

  20. Assessment of ganaxolone's anticonvulsant activity using a randomized, double-blind, presurgical trial design. Ganaxolone Presurgical Study Group.

    Science.gov (United States)

    Laxer, K; Blum, D; Abou-Khalil, B W; Morrell, M J; Lee, D A; Data, J L; Monaghan, E P

    2000-09-01

    A double-blind, randomized, placebo-controlled clinical trial to examine the safety, tolerability, and antiepileptic activity of ganaxolone in patients after withdrawal from other antiepileptic drugs during presurgical evaluations was performed. Fifty-two eligible patients were withdrawn from antiepileptic drugs and randomized to receive ganaxolone (24 patients) or placebo (28 patients) for up to 8 days. Ganaxolone was administered at a dose of 1500 mg/d on day 1 and 1875 mg/d on days 2 to 8. Dosing occurred three times per day: immediately after breakfast, lunch, and dinner. The primary measure of antiepileptic activity was duration of treatment before withdrawal from the trial. Kaplan-Meier curves depicted a clear separation between treatment groups, with 50% of the ganaxolone-treated patients completing the entire study, compared with 25% of patients treated with placebo. Intent-to-treat survival analyses revealed a trend toward efficacy with ganaxolone (p = 0.0795, log rank test). Covariate analyses revealed a significant treatment effect on survival time in men (p = 0.03). Post-hoc chi2 probe analyses focusing on patients who completed the entire study revealed a significant difference (p = 0.04) between treatment groups. The tolerability of ganaxolone was similar to that of placebo, with adverse events being reported by 79% of patients in the ganaxolone group and 68% of patients in the placebo group. Ganaxolone monotherapy was well tolerated for the duration of this clinical trial, and the results provide preliminary evidence that ganaxolone does have antiepileptic activity.

  1. Pulmonary rehabilitation after total laryngectomy: a randomized cross-over clinical trial comparing two different heat and moisture exchangers (HMEs).

    Science.gov (United States)

    Herranz, Jesús; Espiño, María Alvarez; Morado, Carolina Ogen

    2013-09-01

    Post-laryngectomy heat and moisture exchanger (HME) use is known to have a beneficial effect on tracheal climate, pulmonary symptoms and related aspects. This study aims to investigate differences in clinical effects between the first and second generation Provox HMEs. The second generation (Provox XtraHME) has better humidification properties than the first generation (Provox HME), and has been shown to further improve tracheal climate. Forty-five laryngectomized patients, who were already using an HME, participated in a prospective, randomized cross-over clinical study in which each HME was used for 6 weeks. Results showed that for most parameters studied, the second generation HME performed equally well or better than the first generation HME. The improvement in tracheal climate translated into patients reporting significantly less tracheal dryness with the second generation than with the first generation (p = 0.039). Using an HME with better humidification properties is related to a reduction in tracheal dryness in our study population.

  2. Is Zolpidem Associated with Increased Risk of Fractures in the Elderly with Sleep Disorders? A Nationwide Case Cross-Over Study in Taiwan.

    Directory of Open Access Journals (Sweden)

    Yih-Jing Tang

    Full Text Available We conducted a study using a case-crossover design to clarify the risk of acute effects of zolpidem and benzodiazepine on all-sites of fractures in the elderly.Case-crossover design.Elderly enrollees (n = 6010 in Taiwan's National Health Insurance Research Database with zolpidem or benzodiazepine use were analyzed for the risk of developing fractures.After adjusting for medications such as antipsychotics, antidepressants, and diuretics, or comorbidities such as hypertension, osteoarthritis, osteoporosis, rheumatoid arthritis and depression, neither zolpidem nor benzodiazepine was found to be associated with increased risk in all-sites fractures. Subjects without depression were found to have an increased risk of fractures. Diazepam is the only benzodiazepine with increased risk of fractures after adjusting for medications and comorbidities. Hip and spine were particular sites for increased fracture risk, but following adjustment for comorbidities, the associations were found to be insignificant.Neither zolpidem nor benzodiazepine was associated with increased risk of all-site fractures in this case cross-over study after adjusting for medications or comorbidities in elderly individuals with insomnia. Clinicians should balance the benefits and risks for prescribing zolpidem or benzodiazepine in the elderly accordingly.

  3. Design of steel lined pressure tunnels and shafts - Annual report; Dimensionnement des galeries et puits blindes - Rapport annuel

    Energy Technology Data Exchange (ETDEWEB)

    Hachem, F.; Schleiss, A.

    2009-07-01

    Modern power plants are expected to operate at variable speed in a wide range of output power with improved efficiency, flexibility and safety. Therefore, the pumped-storage power generation has gained in importance since it allows storing and generating electricity to supply high peak demands by moving water back and forth between reservoirs at different elevations. A project consortium, called HydroNet (Modern Methodologies for Design, Manufacturing and Operation of Pumped-Storage Power Plant) has been created aiming to converge towards a consistent standardized methodology for design, manufacturing, operation, monitoring and control of pumped-storage power plants in order to give new impulsions in the hydropower technology and maintain the strong position of Switzerland in peak hydropower production as well as in the exportation of high-valued technology. One of the civil engineering field involved in this consortium is the design and control of pressurized shafts and tunnels with a special focus on safety. Since 1980s, no significant fundamental research has been performed aiming to integrate design with interaction between water, steel lining and rock mass. The results of these investigations stand for a crucial target in Switzerland since the collapse of the shallow buried pressure shaft of Cleuson-Dixence hydropower plant in December 2000. (authors)

  4. The Dietary Approaches to Stop Hypertension (DASH) diet affects inflammation in childhood metabolic syndrome: a randomized cross-over clinical trial.

    Science.gov (United States)

    Saneei, Parvane; Hashemipour, Mahin; Kelishadi, Roya; Esmaillzadeh, Ahmad

    2014-01-01

    The effects of the DASH (Dietary Approaches to Stop Hypertension) diet on inflammation in childhood metabolic syndrome (MetS) have still to be identified. To examine the effects of the DASH diet on markers of systemic inflammation in adolescents with MetS. In this randomized, cross-over clinical trial, 60 postpubescent girls with MetS were randomly assigned to receive either the DASH diet menu cycles or usual dietary advice (UDA) for 6 weeks. After a 4-week washout period, participants were crossed over to the alternate arm. The DASH diet was designed to maintain the current body weight. This diet contained high amounts of fruit, vegetables and low-fat dairy products and was low in saturated fats and cholesterol. UDA consisted of general oral advice and written information about healthy food choices based on the Healthy Eating Plate. Compliance to the DASH diet was assessed through quantification of plasma vitamin C levels. Fasting venous blood samples were taken 4 times from each participant: at baseline and at the end of each study arm. Circulating levels of biomarkers of systemic inflammation were quantified according to standard protocols. Mean (SD) age and weight of participants was 14.2 years (1.7) and 69 kg (14.5), respectively. Serum vitamin C levels tended to increase during the DASH phase compared with the UDA phase (16.8 ± 12.9 vs. -13.8 ± 9.7 ng/dl, respectively, p = 0.06) indicating a relatively good compliance to the DASH diet. Adherence to the DASH diet, compared to the UDA, had a significant effect on serum high-sensitivity C-reactive protein levels (p = 0.002). This effect remained significant even after adjustment for weight changes and after further controlling for changes in lipid profiles. We did not observe any significant effect of intervention on levels of serum tumor necrosis factor-alpha, interleukin (IL)-2, IL-6 and adiponectin, in either the crude or adjusted models. There were no significant group*time interactions for any dependent

  5. Rationale and methods of a randomised cross-over cluster trial to assess the effectiveness of MOVI-KIDS on preventing obesity in pre-schoolers.

    Science.gov (United States)

    Martínez-Vizcaino, Vicente; Mota, Jorge; Solera-Martínez, Montserrat; Notario-Pacheco, Blanca; Arias-Palencia, Natalia; García-Prieto, Jorge Cañete; González-García, Alberto; Álvarez-Bueno, Celia; Sánchez-López, Mairena

    2015-02-22

    points were physical activity, fitness, and carotid intima-media thickness. This paper reports the design of a randomised cross-over cluster trial aimed at assessing the effectiveness of the multidimensional physical activity intervention (MOVI-KIDS) during two years in pre-school children. Clinical trials.gov: NCT01971840 . (Date of registration: Initial Release: 10/07/2013; Record Verification: 23/10/2013).

  6. Neurophysiological effects of modafinil on cue-exposure in cocaine dependence: a randomized placebo-controlled cross-over study using pharmacological fMRI.

    Science.gov (United States)

    Goudriaan, Anna E; Veltman, Dick J; van den Brink, Wim; Dom, Geert; Schmaal, Lianne

    2013-02-01

    Enhanced reactivity to substance related cues is a central characteristic of addiction and has been associated with increased activity in motivation, attention, and memory related brain circuits and with a higher probability of relapse. Modafinil was promising in the first clinical trials in cocaine dependence, and was able to reduce craving in addictive disorders. However, its mechanism of action remains to be elucidated. In this functional magnetic resonance imaging (fMRI) study therefore, cue reactivity in cocaine dependent patients was compared to cue reactivity in healthy controls (HCs) under modafinil and placebo conditions. An fMRI cue reactivity study, with a double-blind, placebo-controlled cross-over challenge with a single dose of modafinil (200mg) was employed in 13 treatment seeking cocaine dependent patients and 16 HCs. In the placebo condition, watching cocaine-related pictures (versus neutral pictures) resulted in higher brain activation in the medial frontal cortex, anterior cingulate cortex, angular gyrus, left orbitofrontal cortex, and ventral tegmental area (VTA) in the cocaine dependent group compared to HCs. However, in the modafinil condition, no differences in brain activation patterns were found between cocaine dependent patients and HCs. Group interactions revealed decreased activity in the VTA and increased activity in the right ACC and putamen in the modafinil condition relative to the placebo condition in cocaine dependent patients, whereas such changes were not present in healthy controls. Decreases in self-reported craving when watching cocaine-related cues after modafinil administration compared to the placebo condition were associated with modafinil-induced increases in ACC and putamen activation. Enhanced cue reactivity in the cocaine dependent group compared to healthy controls was found in brain circuitries related to reward, motivation, and autobiographical memory processes. In cocaine dependent patients, these enhanced brain

  7. A water-based training program that include perturbation exercises to improve stepping responses in older adults: study protocol for a randomized controlled cross-over trial.

    Science.gov (United States)

    Melzer, Itshak; Elbar, Ori; Tsedek, Irit; Oddsson, Lars Ie

    2008-08-17

    Gait and balance impairments may increase the risk of falls, the leading cause of accidental death in the elderly population. Fall-related injuries constitute a serious public health problem associated with high costs for society as well as human suffering. A rapid step is the most important protective postural strategy, acting to recover equilibrium and prevent a fall from initiating. It can arise from large perturbations, but also frequently as a consequence of volitional movements. We propose to use a novel water-based training program which includes specific perturbation exercises that will target the stepping responses that could potentially have a profound effect in reducing risk of falling. We describe the water-based balance training program and a study protocol to evaluate its efficacy (Trial registration number #NCT00708136). The proposed water-based training program involves use of unpredictable, multi-directional perturbations in a group setting to evoke compensatory and volitional stepping responses. Perturbations are made by pushing slightly the subjects and by water turbulence, in 24 training sessions conducted over 12 weeks. Concurrent cognitive tasks during movement tasks are included. Principles of physical training and exercise including awareness, continuity, motivation, overload, periodicity, progression and specificity were used in the development of this novel program. Specific goals are to increase the speed of stepping responses and improve the postural control mechanism and physical functioning. A prospective, randomized, cross-over trial with concealed allocation, assessor blinding and intention-to-treat analysis will be performed to evaluate the efficacy of the water-based training program. A total of 36 community-dwelling adults (age 65-88) with no recent history of instability or falling will be assigned to either the perturbation-based training or a control group (no training). Voluntary step reaction times and postural stability

  8. Efficacy of dental floss and chlorhexidine mouth rinse as an adjunct to toothbrushing in removing plaque and gingival inflammation - a three way cross over trial.

    Science.gov (United States)

    Arora, Vikram; Tangade, Pradeep; T L, Ravishankar; Tirth, Amit; Pal, Sumit; Tandon, Vaibhav

    2014-10-01

    Maintaining good oral hygiene is important to combat periodontal diseases. The use of tooth brush alone does not serve the purpose of removing plaque which demands the use of some adjuncts such as proximal cleaning aids. The study was conducted to compare the efficacy of Dental Floss and 0.12% Chlorhexidine Gluconate Mouthrinse as an adjunct to toothbrushing on plaque accumulation and gingival inflammation. Department of Public Health Dentistry, Kothiwal Dental College and Research Centre, Moradabad, India. This was a randomized, double blind, three-way cross over clinical trial. Forty five dental students in the age group of 19-25yr. were enrolled into the study. Subjects were randomly assigned into three groups (n=15) i.e. Group A- Toothbrushing with Dental floss (TB+DF), Group B- Toothbrushing with 0.12% Chlorhexidine Gluconate Mouthrinse (TB+CHX-MR) and Group C- Toothbrushing alone (TB Alone) in a three-way crossover manner. After 21 d of trial period, plaque index (PI) and gingival index (GI) were assessed for each group, oral prophylaxis followed by a washout period for 14d. Mean, standard deviations and p-values were obtained. ANOVA test was used to compare the intergroup difference and Post hoc test to compare between the two groups. The inter-group comparison for GI and PI at all interventions showed statistically significant difference (p<0.001). While comparing between group A and group C at second and third follow up, no significant difference were observed though group A showed reduction in mean values for both the clinical parameters whereas while comparing between group A and group B, statistically significant difference was observed, which is in line when compared with group B and group C. The Group B showed more reduction in plaque and gingival scores which was found to be statistically significant (p<0.001). CHX-MR when used as an adjunct to toothbrushing is more effective in the reduction of plaque and gingival scores than a toothbrush alone or

  9. Comparison of 0.5% articaine and 0.5% prilocaine in intravenous regional anesthesia of the arm: a cross-over study in volunteers.

    Science.gov (United States)

    Pitkänen, M T; Xu, M; Haasio, J; Rosenberg, P H

    1999-01-01

    Earlier studies of the use of articaine in intravenous regional anesthesia (IVRA) are conflicting. In fact, despite similar physicochemical properties and regional anesthetic action, significant differences between articaine and prilocaine in IVRA have been reported. Articaine, being a potent local anesthetic with low degree of toxicity and being rapidly metabolized by esterases, could be a useful local anesthetic particularly in IVRA and, perhaps, could challenge prilocaine, the present local anesthetic of choice for this technique. A double-blind, cross-over study of IVRA of the upper extremity in 10 healthy volunteers was performed. There was at least a 1-week interval between the use of the two anesthetics in each volunteer. After exsanguination with an Esmarch bandage, IVRA was induced either with preservative-free 0.5% articaine (5% Ultracaine, Hoechst, Germany, diluted with 0.9% NaCl) or 0.5% prilocaine (Citanest, Astra, Södertälje, Sweden) (35-50 mL, according to weight), injected in 2 minutes. Sensation at defined skin spots that were innervated by the median, musculocutaneous, radial, and ulnar nerves was tested by pinprick; motor function was tested by the movements of the wrist. After 20 minutes, the tourniquet cuff was deflated in one step. Circulatory, toxic, and skin reactions were registered. At least 1 week after the second IVRA intracutaneous allergy testing with 0.5% articaine, 0.5% prilocaine, histamine, and saline was performed. There were no significant differences between the two local anesthetics in the onset of analgesia or anesthesia, degree of motor block, and recovery of IVRA. Onset of analgesia occurred 4.2-5.6 minutes, on average, after the injection. One volunteer had short-lasting tinnitus after tourniquet cuff deflation when prilocaine was used. Erythematous nonitching skin rashes developed in 8 of 10 volunteers when articaine was used, and two volunteers had rashes when prilocaine was used. These rashes disappeared within an hour

  10. Muscle Activation of Vastus Medialis Oblique and Vastus Lateralis in Sling-Based Exercises in Patients with Patellofemoral Pain Syndrome: A Cross-Over Study

    Directory of Open Access Journals (Sweden)

    Wen-Dien Chang

    2015-01-01

    Full Text Available Objectives. To examine what changes are caused in the activity of the vastus medialis oblique (VMO and vastus lateralis (VL at the time of sling-based exercises in patients with patellofemoral pain syndrome (PFPS and compare the muscular activations in patients with PFPS among the sling-based exercises. Methods. This was a cross-over study. Sling-based open and closed kinetic knee extension and hip adduction exercises were designed for PFPS, and electromyography was applied to record maximal voluntary contraction during the exercises. The VMO and VL activations and VMO : VL ratios for the three exercises were analyzed and compared. Results. Thirty male (age = 21.19 ± 0.68 y and 30 female (age = 21.12 ± 0.74 y patients with PFPS were recruited. VMO activations during the sling-based open and closed kinetic knee extension exercises were significantly higher (P=0.04 and P=0.001 than those during hip adduction exercises and VMO : VL ratio for the sling-based closed kinetic knee extension and hip adduction exercises approximated to 1. Conclusions. The sling-based closed kinetic knee extension exercise produced the highest VMO activation. It also had an appropriate VMO : VL ratio similar to sling-based hip adduction exercise and had beneficial effects on PFPS.

  11. Bioavailability of β-cryptoxanthin is greater from pasteurized orange juice than from fresh oranges - a randomized cross-over study.

    Science.gov (United States)

    Aschoff, Julian K; Rolke, Christa L; Breusing, Nicolle; Bosy-Westphal, Anja; Högel, Josef; Carle, Reinhold; Schweiggert, Ralf M

    2015-10-01

    Orange fruits and products thereof represent important dietary sources of carotenoids, particularly β-cryptoxanthin. Since previous studies reported a positive effect of vegetable processing on carotenoid absorption, our objective was to compare the bioavailability of β-cryptoxanthin from either fresh navel oranges (Citrus sinensis L. Osbeck) or pasteurized orange juice. The study was designed as a randomized 2-way cross-over study. Twelve volunteers consumed two meals delivering 744 μg of β-cryptoxanthin from either fresh navel oranges or pasteurized orange juice. Eight blood samples were collected over 9.5 h after test meal consumption and analyzed using HPLC-DAD. Additionally, carotenoid bioaccessibility was assessed after in vitro digestion of the same test foods. β-cryptoxanthin bioavailability from pasteurized orange juice was 1.8-fold higher than from fresh oranges (P = 0.011). Similarly, mean absorption of the non-dose adjusted carotenoids lutein (P = 0.301), zeaxanthin (P = 0.216), and zeinoxanthin (P = 0.090) were slightly higher from orange juice, although not reaching statistical significance. The in vitro digestion revealed a 5.3-fold higher bioaccessibility of β-cryptoxanthin from orange juice. Dietary fiber contents in the test foods were inversely associated with carotenoid bioavailability. Orange juice represents a more bioavailable source of β-cryptoxanthin than fresh oranges. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  12. Urinary excretion of Citrus flavanones and their major catabolites after consumption of fresh oranges and pasteurized orange juice: A randomized cross-over study.

    Science.gov (United States)

    Aschoff, Julian K; Riedl, Ken M; Cooperstone, Jessica L; Högel, Josef; Bosy-Westphal, Anja; Schwartz, Steven J; Carle, Reinhold; Schweiggert, Ralf M

    2016-12-01

    Orange juice contains flavanones including hesperidin and narirutin, albeit at lower concentrations as compared to orange fruit. Therefore, we compared bioavailability and colonic catabolism of flavanones from orange juice to a 2.4-fold higher dose from fresh oranges. Following a randomized two-way cross-over design, 12 healthy subjects consumed a test meal comprising either fresh oranges or pasteurized orange juice, delivering 1774 and 751 μmol of total Citrus flavanones, respectively. Deglucuronidated and desulfated hesperetin, naringenin, and the flavanone catabolites 3-(3'-hydroxy-4'-methoxyphenyl)propionic acid, 3-(3'-hydroxyphenyl)hydracrylic acid, 4-hydroxyhippuric acid, and hippuric acid were quantitated in 24-h urine by UHPLC-MS/MS. Differences in urinary hesperetin excretion were found to be nonsignificant (p = 0.5209) both after consumption of orange fruit (21.6 ± 8.0 μmol) and juice (18.3 ± 7.2 μmol). By analogy, postprandial flavanone catabolite excretions were highly similar between treatments. Excretion of 3-(3'-hydroxy-4'-methoxyphenyl)propionic acid was inversely related to that of hesperetin, illustrating the catabolite/precursor relationship. Despite 2.4-fold higher doses, excretion of flavanones from ingested fresh orange fruit did not differ from that following orange juice consumption, possibly due to a saturation of absorption or their entrapment in the fiber-rich matrix of the fruit. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  13. Effect of grape seed extract on postprandial oxidative status and metabolic responses in men and women with the metabolic syndrome - randomized, cross-over, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Indika Edirisinghe

    2012-12-01

    Full Text Available Objective: This investigation was undertaken to determine whether a grape seed extract (GSE that is rich in mono-, oligo- and poly- meric polyphenols would modify postprandial oxidative stress and inflammation in individuals with the metabolic syndrome (MetS.Background: MetS is known to be associated with impaired glucose tolerance and poor glycemic control. Consumption of a meal high in readily available carbohydrates and fat causes postprandial increases in glycemia and lipidemia and markers of oxidative stress, inflammation and insulin resistance. Materials/methods: After an overnight fast, twelve subjects with MetS (5 men and 7 women consumed a breakfast meal high in fat and carbohydrate in a cross-over design. A GSE (300 mg or placebo capsule was administrated 1 hr before the meal (-1 hr. Changes in plasma insulin, glucose, oxidative stress and inflammatory markers were measured hourly for 6 hr. Results: Plasma hydrophilic oxygen radical absorbance capacity (ORAC measured as the positive incremental area under the curve (-1 to 5 hr was significantly increased when the meal was preceded by GSE compared with placebo (P0.05. No changes in inflammatory markers were evident. Conclusion: These data suggest that GSE enhances postprandial plasma antioxidant status and reduces the glycemic response to a meal, high in fat and carbohydrate in subjects with the MetS.

  14. A cross-over study comparing an online versus a paper 7-day food record: focus on total water intake data and participant's perception of the records.

    Science.gov (United States)

    Monnerie, B; Tavoularis, L G; Guelinckx, I; Hebel, P; Boisvieux, T; Cousin, A; Le Bellego, L

    2015-06-01

    To compare (1) fluid, food and nutrient intake obtained with a paper versus an online version of a 7-day food record and (2) user's acceptability of both versions of the food record. A cross-over study was carried out in 2010 in France. A total of 246 participants aged 18-60 years reported their food and fluid intake using both versions of the 7-day food record, separated by a 7- to 14-day washout period. To help participants in estimating consumed portions, both versions of the food record were supported by a photographic booklet of standard portions and containers. At the end of the study protocol, participants completed a questionnaire designed to assess the acceptability of the two questionnaires. The reported water intake of fluids was significantly higher with the online version compared with the paper version (respectively 1348 ± 36 and 1219 ± 34 mL/day, p < 0.0001). No difference was found between methods in terms of energy intake and the consumption of most food categories, macro- and micronutrients. Furthermore, 77 % of the participants preferred the online method to the paper version. Fluid intake, but not food intake, reported with the online 7-day food record was higher in comparison with the paper version. In addition, the online version was preferred by users. In population surveys, the online record is therefore a relevant alternative, and even a preferred alternative in the case of fluid intake, to the paper record.

  15. Rationale and design of the participant, investigator, observer, and data-analyst-blinded randomized AGENDA trial on associations between gene-polymorphisms, endophenotypes for depression and antidepressive intervention: the effect of escitalopram versus placebo on the combined dexamethasone

    DEFF Research Database (Denmark)

    Knorr, Ulla; Vinberg, Maj; Klose, Marianne

    2009-01-01

    from baseline to the end of intervention. METHODS: The AGENDA trial is designed as a participant, investigator, observer, and data-analyst-blinded randomized trial. Participants are 80 healthy first-degree relatives of patients with depression. Participants are randomized to escitalopram 10 mg per day...

  16. Immediate response in markers of inflammation and angiogenesis during exercise: a randomised cross-over study in heart transplant recipients.

    Science.gov (United States)

    Yardley, Marianne; Ueland, Thor; Aukrust, Pål; Michelsen, Annika; Bjørkelund, Elisabeth; Gullestad, Lars; Nytrøen, Kari

    2017-01-01

    The present study explored and compared the immediate responses in markers of inflammation and angiogenesis in maintenance heart transplant (HTx) recipients before, during and after sessions of high-intensity interval training (HIT) versus moderate-intensity continuous training (MICT). The study aimed to explain some of the trigger mechanisms behind HIT in HTx recipients. This cross-over study included 14 HTx patients (mean±SD age: 53±13 years; time since HTx, 3±2 years). All participants underwent baseline blood samples and a cardiopulmonary exercise test during their first visit. The next two visits included one HIT session and one MICT session, in randomised order. Blood samples were taken during and after each exercise session. Myokines and inflammatory markers related to vascular inflammation, blood-platelet activation and modulation of angiogenesis were analysed. The main findings in this study were (1) exercise, regardless of intensity, induced a significant immediate response in several vascular, angiogenetic and in particular platelet-derived inflammatory mediators in HTx recipients. (2) HIT showed trends to induce an increased response in von Willebrand factor, vascular endothelial growth factor-1 and angiopoetin-2, and a decreased response in growth differentiation factor-15, compared with MICT. This pattern and in particular the trend towards an increased angiogenetic mediator response could contribute to the beneficial effects of HIT in HTx recipients. NCT02602834.

  17. Effects of 24 h working on-call on psychoneuroendocrine and oculomotor function: a randomized cross-over trial.

    Science.gov (United States)

    Ernst, Florian; Rauchenzauner, Markus; Zoller, Heinz; Griesmacher, Andrea; Hammerer-Lercher, Angelika; Carpenter, Roger; Schuessler, Gerhard; Joannidis, Michael

    2014-09-01

    On-call duty (OCD) is frequently associated with health and safety risks for both physicians and patients. The lack of studies conducted in clinical care environments and the ongoing public dialogue concerning OCD led to a detailed investigation of a working schedule including sleep fragmentation and extended work hours. Within-person randomized cross-over trial. Comparison of a 24h on-call shift (OCD) compared to a routine working-day (non on call, NOC) in hospital. 30 residents and senior physicians of the Department of Internal Medicine, Neurology and Otorhinolaryngology at the University Hospital Innsbruck. Sleep variables, cognitive performance (Concentration-Endurance d2 test), emotional status (Eigenschaftswoerterliste 60S), serum-cortisol, urinary cortisol and noradrenaline, heart-rate variability, and saccadic eye movements were determined before and after OCD and NOC respectively. Concentration-endurance performance was significantly reduced after OCD as compared to NOC by 16.4% (pconcentration and performance related activation after OCD by 17.4% (psleep interruptions. The discrepancy between subjective feeling and objective cognitive impairments pose a risk for performing complex manual and cognitive tasks. Hence, our findings argue against an oversimplified interpretation of alterations in the physicians' psychoneuroendocrine structure in terms of impaired mood and neurocognitive deterioration combined with up-/dysregulated stress axes associated with OCD as a consequence of sleep deprivation. Copyright © 2014 Elsevier Ltd. All rights reserved.

  18. Effects of Sub-Sensory Noise and Fatigue on Knee Landing and Cross-Over Cutting Biomechanics in Male Athletes.

    Science.gov (United States)

    Qu, Xingda; Jiang, Jianxin; Hu, Xinyao

    2018-01-24

    The objective of this study was to examine the effects of sub-sensory noise and fatigue on knee biomechanics during the athletic task of landing followed by cross-over cutting. Thirty-two healthy male athletes participated in the study. They were evenly divided into two groups: no fatigue group and fatigue group. Fatigue was induced to the lower extremity by a repetitive squatting exercise in the fatigue group. Sub-sensory noise was generated by linear miniature vibrators bilaterally placed around the knee joints. During data collection, the participants were instructed to perform landing followed by crossover cutting in both the sub-sensory on and off conditions. Dependent variables were selected to assess knee biomechanics in the phases of landing and crossover cutting, separately. Results showed that fatigue resulted in larger knee flexion during landing and larger knee internal rotation during crossover cutting. Sub-sensory noise was found to reduce knee rotation impulse during crossover cutting. These findings suggests that crossover cutting is more dangerous than landing in the fatigue condition, and sub-sensory noise may lead to changes in knee biomechanics consistent with reduced risk of ACL injuries, but the changes may be task-specific.

  19. Combining walking and relaxation for stress reduction-A randomized cross-over trial in healthy adults.

    Science.gov (United States)

    Matzer, Franziska; Nagele, Eva; Lerch, Nikolaus; Vajda, Christian; Fazekas, Christian

    2017-08-25

    Both physical activity and relaxation have stress-relieving potential. This study investigates their combined impact on the relaxation response while considering participants' initial stress level. In a randomized cross-over trial, 81 healthy adults completed 4 types of short-term interventions for stress reduction, each lasting for 1 hr: (1) physical activity (walking) combined with resting, (2) walking combined with balneotherapy, (3) combined resting and balneotherapy, and (4) resting only. Saliva cortisol, blood pressure, state of mood, and relaxation were measured preintervention and postintervention. Stress levels were determined by validated questionnaires. All interventions were associated with relaxation responses in the variables saliva cortisol, blood pressure, state of mood, and subjective relaxation. No significant differences were found regarding the reduction of salivary cortisol (F = 1.30; p = .281). The systolic blood pressure was reduced best when walking was combined with balneotherapy or resting (F = 7.34; p relaxation (resting or balneotherapy) is an advantageous short-term strategy for stress reduction as systolic blood pressure is reduced best while similar levels of relaxation can be obtained. Copyright © 2017 John Wiley & Sons, Ltd.

  20. Double-blind clinical trial of thalamic stimulation in patients with Tourette syndrome

    NARCIS (Netherlands)

    Ackermans, Linda; Duits, Annelien; van der Linden, Chris; Tijssen, Marina; Schruers, Koen; Temel, Yasin; Kleijer, Mariska; Nederveen, Pieter; Bruggeman, Richard; Tromp, Selma; van Kranen-Mastenbroek, Vivianne; Kingma, Herman; Cath, Danielle; Visser-Vandewalle, Veerle

    Deep brain stimulation of the thalamus has been proposed as a therapeutic option in patients with Tourette syndrome who are refractory to pharmacological and psychotherapeutic treatment. Patients with intractable Tourette syndrome were invited to take part in a double-blind randomized cross-over

  1. Double-blind clinical trial of thalamic stimulation in patients with Tourette syndrome

    NARCIS (Netherlands)

    Ackermans, Linda; Duits, Annelien; van der Linden, Chris; Tijssen, Marina; Schruers, Koen; Temel, Yasin; Kleijer, Mariska; Nederveen, Pieter; Bruggeman, Richard; Tromp, Selma; van Kranen-Mastenbroek, Vivianne; Kingma, Herman; Cath, Danielle; Visser-Vandewalle, Veerle

    2011-01-01

    Deep brain stimulation of the thalamus has been proposed as a therapeutic option in patients with Tourette syndrome who are refractory to pharmacological and psychotherapeutic treatment. Patients with intractable Tourette syndrome were invited to take part in a double-blind randomized cross-over

  2. The effectiveness of healthy meals at work on reaction time, mood and dietary intake: a randomised cross-over study in daytime and shift workers at an university hospital

    DEFF Research Database (Denmark)

    Leedo, Eva; Beck, Anne Marie; Astrup, Arne

    2017-01-01

    Our dietary habits affect both cognitive performance and mood. The aim of the study was to examine the effect of increased availability of healthy meals and water at work on healthcare staff. The study used an 8-week randomised cross-over design. A total of sixty physicians, nurses and nursing...... assistants, including sixteen working on shifts, were recruited. The participants received a self-selected keyhole-labelled (Nordic nutrition label) lunch, snack and bottled water during each shift throughout the intervention period. Reaction time (Go/No-Go test), mood-related scores (POMS) and dietary...

  3. Development of a cross-over randomized trial method to determine the acceptability and safety of novel ready-to-use therapeutic foods.

    Science.gov (United States)

    Dibari, Filippo; Bahwere, Paluku; Huerga, Helena; Irena, Abel Hailu; Owino, Victor; Collins, Steve; Seal, Andrew

    2013-01-01

    To develop a method for determining the acceptability and safety of ready-to-use therapeutic foods (RUTF) before clinical trialing. Acceptability was defined using a combination of three consumption, nine safety, and six preference criteria. These were used to compare a soy/maize/sorghum RUTF (SMS-RUTFh), designed for the rehabilitation of human immunodeficiency virus/tuberculosis (HIV/TB) wasted adults, with a peanut-butter/milk-powder paste (P-RUTF; brand: Plumpy'nut) designed for pediatric treatment. A cross-over, randomized, controlled trial was conducted in Kenya. Ten days of repeated measures of product intake by 41 HIV/TB patients, >18 y old, body mass index (BMI) 18-24 kg · m(-2), 250 g were offered daily under direct observation as a replacement lunch meal. Consumption, comorbidity, and preferences were recorded. The study arms had similar age, sex, marital status, initial BMI, and middle upper-arm circumference. No carryover effect or serious adverse events were found. SMS-RUTFh energy intake was not statistically different from the control, when adjusted for BMI on day 1, and the presence of throat sores. General preference, taste, and sweetness scores were higher for SMS-RUTFh compared to the control (P preference criteria for SMS-RUTFh were satisfied except for the average number of days of nausea (0.16 versus 0.09 d) and vomiting (0.04 versus 0.02 d), which occurred with a higher frequency (P < 0.05). SMS-RUTFh appears to be acceptable and can be safely clinically trialed, if close monitoring of vomiting and nausea is included. The method reported here is a useful and feasible approach for testing the acceptability of ready-to-use foods in low income countries. Copyright © 2013 Elsevier Inc. All rights reserved.

  4. Bioavailability of sulforaphane from two broccoli sprout beverages: Results of a short term, cross-over clinical trial in Qidong, China

    Science.gov (United States)

    Egner, Patricia A.; Chen, Jian Guo; Wang, Jin Bing; Wu, Yan; Sun, Yan; Lu, Jian Hua; Zhu, Jian; Zhang, Yong Hui; Chen, Yong Sheng; Friesen, Marlin D.; Jacobson, Lisa P.; Muñoz, Alvaro; Ng, Derek; Qian, Geng Sun; Zhu, Yuan Rong; Chen, Tao Yang; Botting, Nigel P.; Zhang, Qingzhi; Fahey, Jed W.; Talalay, Paul; Groopman, John D; Kensler, Thomas W.

    2011-01-01

    One of several challenges in design of clinical chemoprevention trials is the selection of the dose, formulation and dose schedule of the intervention agent. Therefore, a cross-over clinical trial was undertaken to compare the bioavailability and tolerability of sulforaphane from two of broccoli sprout-derived beverages: one glucoraphanin-rich (GRR) and the other sulforaphane-rich (SFR). Sulforaphane was generated from glucoraphanin contained in GRR by gut microflora or formed by treatment of GRR with myrosinase from daikon (Raphanus sativus) sprouts to provide SFR. Fifty healthy, eligible participants were requested to refrain from crucifer consumption and randomized into two treatment arms. The study design was as follows: 5-day run-in period, 7-day administration of beverages, 5-day washout period, and 7-day administration of the opposite intervention. Isotope dilution mass spectrometry was used to measure levels of glucoraphanin, sulforaphane and sulforaphane thiol conjugates in urine samples collected daily throughout the study. Bioavailability, as measured by urinary excretion of sulforaphane and its metabolites (in approximately 12 hour collections after dosing), was substantially greater with the SFR (mean = 70%) than with GRR (mean = 5%) beverages. Interindividual variability in excretion was considerably lower with SFR than GRR beverage. Elimination rates were considerably slower with GRR allowing for achievement of steady state dosing as opposed to bolus dosing with SFR. Optimal dosing formulations in future studies should consider blends of sulforaphane and glucoraphanin as SFR and GRR mixtures to achieve peak concentrations for activation of some targets and prolonged inhibition of others implicated in the protective actions of sulforaphane. PMID:21372038

  5. MTN-001: Randomized Pharmacokinetic Cross-Over Study Comparing Tenofovir Vaginal Gel and Oral Tablets in Vaginal Tissue and Other Compartments

    Science.gov (United States)

    Hendrix, Craig W.; Chen, Beatrice A.; Guddera, Vijayanand; Hoesley, Craig; Justman, Jessica; Nakabiito, Clemensia; Salata, Robert; Soto-Torres, Lydia; Patterson, Karen; Minnis, Alexandra M.; Gandham, Sharavi; Gomez, Kailazarid; Richardson, Barbra A.; Bumpus, Namandje N.

    2013-01-01

    Background Oral and vaginal preparations of tenofovir as pre-exposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection have demonstrated variable efficacy in men and women prompting assessment of variation in drug concentration as an explanation. Knowledge of tenofovir concentration and its active form, tenofovir diphosphate, at the putative vaginal and rectal site of action and its relationship to concentrations at multiple other anatomic locations may provide key information for both interpreting PrEP study outcomes and planning future PrEP drug development. Objective MTN-001 was designed to directly compare oral to vaginal steady-state tenofovir pharmacokinetics in blood, vaginal tissue, and vaginal and rectal fluid in a paired cross-over design. Methods and Findings We enrolled 144 HIV-uninfected women at 4 US and 3 African clinical research sites in an open label, 3-period crossover study of three different daily tenofovir regimens, each for 6 weeks (oral 300 mg tenofovir disoproxil fumarate, vaginal 1% tenofovir gel [40 mg], or both). Serum concentrations after vaginal dosing were 56-fold lower than after oral dosing (pwomen with vaginal dosing and only 19% of women with oral dosing. Vaginal tissue tenofovir diphosphate was ≥130-fold higher with vaginal compared to oral dosing (poral only dosing period (poral dosing, vaginal dosing achieved much lower serum concentrations and much higher vaginal tissue concentrations. Even allowing for 100-fold concentration differences due to poor adherence or less frequent prescribed dosing, vaginal dosing of tenofovir should provide higher active site concentrations and theoretically greater PrEP efficacy than oral dosing; randomized topical dosing PrEP trials to the contrary indicates that factors beyond tenofovir’s antiviral effect substantially influence PrEP efficacy. Trial Registration ClinicalTrials.gov NCT00592124 PMID:23383037

  6. Neurofeedback to improve neurocognitive functioning of children treated for a brain tumor: design of a randomized controlled double-blind trial

    Directory of Open Access Journals (Sweden)

    de Ruiter Marieke A

    2012-12-01

    Full Text Available Abstract Background Neurotoxicity caused by treatment for a brain tumor is a major cause of neurocognitive decline in survivors. Studies have shown that neurofeedback may enhance neurocognitive functioning. This paper describes the protocol of the PRISMA study, a randomized controlled trial to investigate the efficacy of neurofeedback to improve neurocognitive functioning in children treated for a brain tumor. Methods/Design Efficacy of neurofeedback will be compared to placebo training in a randomized controlled double-blind trial. A total of 70 brain tumor survivors in the age range of 8 to 18 years will be recruited. Inclusion also requires caregiver-reported neurocognitive problems and being off treatment for more than two years. A group of 35 healthy siblings will be included as the control group. On the basis of a qEEG patients will be assigned to one of three treatment protocols. Thereafter patients will be randomized to receive either neurofeedback training (n=35 or placebo training (n=35. Neurocognitive tests, and questionnaires administered to the patient, caregivers, and teacher, will be used to evaluate pre- and post-intervention functioning, as well as at 6-month follow-up. Siblings will be administered the same tests and questionnaires once. Discussion If neurofeedback proves to be effective for pediatric brain tumor survivors, this can be a valuable addition to the scarce interventions available to improve neurocognitive and psychosocial functioning. Trial registration ClinicalTrials.gov NCT00961922.

  7. The Effect of Plastic Cover on Regulation of Vital Signs in Preterm Infants: A Randomized Cross-over Clinical Trial

    Directory of Open Access Journals (Sweden)

    Leila Valizadeh

    2017-06-01

    Full Text Available Background: Considering the susceptibility of preterm infants to disturbances of vital signs, this study was conducted to investigate the effects of using plastic covers on regulation of vital signs in preterm neonates.Methods: This randomized, cross-over, clinical trial was carried out on 80 preterm infants admitted to neonatal intensive care unit (NICU of Taleghani Hospital, Tabriz, Iran. The study was conducted in two days (on the second and third days of the infants’ life. In group 1, plastic cover was used during the first day followed by the use of blanket on the second day, while the order was reversed in group 2. Digital thermometer was used to measure the infants’ axillary temperature. Heart rate and oxygen saturation were measured through monitoring. To analyze the data, descriptive (Mean and SE, 95%CI and inferential statistics (repeated measurement and ANCOVA tests were used in SPSS version 13 and MiniTab software.Results: Fourteen infants who were covered with blanket were found to suffer from hypothermia, while no infant with a plastic cover encountered this problem. The percentage of arterial blood oxygen saturation in the group with plastic covers was higher, and as a result, the infants received less oxygen supplements. However, no statistically significant differences were observed in heart rate between the groups.Conclusion: Use of plastic cover during NICU stay prevented hypothermia in premature infants, with the arterial blood oxygen saturation being within the normal limits. Yet, it did not seem to have a significant effect on other vital signs.

  8. Effects of lipid emulsion particle size on satiety and energy intake: a randomised cross-over trial.

    Science.gov (United States)

    Poppitt, Sally D; Budgett, Stephanie C; MacGibbon, Alastair K; Quek, Siew-Young; Kindleysides, Sophie; Wiessing, Katy R

    2018-03-01

    Emulsified lipids, with central lipid core surrounded by polar lipid 'protective coat', have been proposed to stimulate the ileal brake, alter appetite, food intake and aid weight control. In addition to lipid composition, emulsion particle size may contribute to efficacy with small droplets providing a larger surface area for gastrointestinal (GI) lipase action and larger droplets prolonging and delaying digestion in the GI tract. Tube feeding studies delivering emulsions directly into the small intestine show clear effects of smaller particle size on appetite and food intake, but evidence from oral feeding studies is sparse. The objective of this study was to determine the effects of lipid emulsion particle size on appetite response and food intake. In a three-arm randomised cross-over, high-phospholipid (PL) dairy lipid emulsions or matched control were consumed at breakfast within a yoghurt smoothie: (i) large-particle size emulsion, LPE (diameter 0.759 µm, 10 g lipid emulsion, 190 g yoghurt), (ii) small-particle size emulsion, SPE (diameter 0.290 µm, 10 g lipid emulsion, 190 g yoghurt), (iii) control non-emulsion, NE (10 g non-emulsion lipid, 190 g yoghurt). Twenty male participants completed the study, where postprandial appetite response was rated using visual analogue scales (VAS) and ad libitum energy intake at a lunch meal measured 3 h later. There was a trend for LPE to suppress hunger (P = 0.08) and enhance fullness (P = 0.24) relative to both SPE and NE but not statistically significant, and no significant effect of either emulsion on food intake at the lunch meal (P > 0.05). Altering particle size of a high-PL emulsion did not enhance satiety or alter eating behaviour in a group of lean men.

  9. Electromyographic Comparison of Barbell Deadlift, Hex Bar Deadlift, and Hip Thrust Exercises: A Cross-Over Study.

    Science.gov (United States)

    Andersen, Vidar; Fimland, Marius S; Mo, Dag-Andrè; Iversen, Vegard M; Vederhus, Torbjørn; Rockland Hellebø, Lars R; Nordaune, Kristina I; Saeterbakken, Atle H

    2018-03-01

    Andersen, V, Fimland, MS, Mo, D-A, Iversen, VM, Vederhus, T, Rockland Hellebø, LR, Nordaune, KI, and Saeterbakken, AH. Electromyographic comparison of barbell deadlift, hex bar deadlift, and hip thrust exercises: a cross-over study. J Strength Cond Res 32(3): 587-593, 2018-The aim of the study was to compare the muscle activation level of the gluteus maximus, biceps femoris, and erector spinae in the hip thrust, barbell deadlift, and hex bar deadlift; each of which are compound resisted hip extension exercises. After 2 familiarization sessions, 13 resistance-trained men performed a 1 repetition maximum in all 3 exercises in 1 session, in randomized and counterbalanced order. The whole ascending movement (concentric phase), as well as its lower and upper parts (whole movement divided in 2), were analyzed. The hip thrust induced greater activation of the gluteus maximus compared with the hex bar deadlift in the whole (16%, p = 0.025) and the upper part (26%, p = 0.015) of the movement. For the whole movement, the biceps femoris was more activated during barbell deadlift compared with both the hex bar deadlift (28%, p bar deadlift (p = 0.049) compared with hip thrust. Biceps femoris activation in the upper part of the movement was 39% higher for the barbell deadlift compared with the hex bar deadlift (p = 0.001) and 34% higher for the hip thrust compared with the hex bar deadlift (p = 0.002). No differences were displayed for the erector spinae activation (p = 0.312-0.859). In conclusion, the barbell deadlift was clearly superior in activating the biceps femoris compared with the hex bar deadlift and hip thrust, whereas the hip thrust provided the highest gluteus maximus activation.

  10. Glycemic Response to Black Beans and Chickpeas as Part of a Rice Meal: A Randomized Cross-Over Trial.

    Science.gov (United States)

    Winham, Donna M; Hutchins, Andrea M; Thompson, Sharon V

    2017-10-04

    Legumes, such as black beans ( Phaseolus vulgaris L.) and chickpeas ( Cicer arietinum L.), have a low glycemic index, and may reduce the glycemic load of meals in which they are included. Although the low glycemic response of beans consumed alone has been documented, few studies have examined the glycemic response to traditional food combinations such as black beans and rice or chickpeas and rice. This randomized cross-over study examined the glycemic and insulinemic impact of 50 grams of available carbohydrate from three test meals: plain white rice (control), black beans with rice, and chickpeas with rice among healthy adult women ( n = 12, 18-65 years). Treatments were consumed on different mornings, a minimum of 7 days apart. Blood samples were collected at time 0 (fasting), and at 30, 60, 90, and 120 min postprandial, and were subsequently analyzed for glucose and insulin concentrations. Glucose response based on the incremental area under the curve showed a significant difference by treatment ( p = 0.027). Changes in blood glucose concentrations were significantly different for the black bean meal and the chickpea meal in comparison to rice alone at 60 min ( p = 0.026 and p = 0.024), 90 min ( p = 0.001 and p = 0.012) and 120 min post prandial ( p = 0.024; black bean meal). Findings indicate that combinations of black beans and chickpeas with white rice improve glycemic response, providing evidence that has promising implications for dietary guidance to reduce postprandial glucose and related health risks through traditional food patterns.

  11. Effects of prone and supine positioning on gastric residuals in preterm infants: a time series with cross-over study.

    Science.gov (United States)

    Chen, Shiau-Shr; Tzeng, Ya-Ling; Gau, Bih-Shya; Kuo, Pi-Chao; Chen, Jia-Yuh

    2013-11-01

    Few studies have examined the effect of body position on gastric residuals at different time points in feeding preterm infants. Further, the results of previous studies are inconsistent. To describe the changing pattern of gastric residuals over time in the prone and supine position and to examine the effects of position on gastric residuals at different feeding volumes in preterm infants. A randomized, time series with cross-over study. A neonatal intensive care unit affiliated with a medical center in central Taiwan. 35 preterm infants who were asymptomatic for gastroesophageal reflux, other gastrointestinal diseases or other significant morbidities of any kind other than prematurity. Infants were randomly assigned to the following treatments: 3h in a supine position followed by 3h in a prone position, or vice versa. Measurements of gastric residual volume were taken by syringe at 30, 60, 90, 120 and 150 min following feeding when the enteral intake was set at 50 or 100ml/kg/day. The rate of decrease of gastric residuals in the prone and supine positions was fastest during the first half an hour post-feeding according to measurements taken at 30, 60, 90, 120 and 150 min at feeding volumes of 50 and 100ml/kg/day (pposition at the five measurement points. Placing preterm infants in the prone position for the first half an hour post-feeding and then changing the position according to the behavior cues of the infants is suggested. This result contributes to a better understanding of the relationships between time, position, and gastric residuals; it could also help health care professionals to provide efficient feeding as well as perform the appropriate positioning of preterm infants. Copyright © 2013 Elsevier Ltd. All rights reserved.

  12. Glycemic Response to Black Beans and Chickpeas as Part of a Rice Meal: A Randomized Cross-Over Trial

    Directory of Open Access Journals (Sweden)

    Donna M. Winham

    2017-10-01

    Full Text Available Legumes, such as black beans (Phaseolus vulgaris L. and chickpeas (Cicer arietinum L., have a low glycemic index, and may reduce the glycemic load of meals in which they are included. Although the low glycemic response of beans consumed alone has been documented, few studies have examined the glycemic response to traditional food combinations such as black beans and rice or chickpeas and rice. This randomized cross-over study examined the glycemic and insulinemic impact of 50 grams of available carbohydrate from three test meals: plain white rice (control, black beans with rice, and chickpeas with rice among healthy adult women (n = 12, 18–65 years. Treatments were consumed on different mornings, a minimum of 7 days apart. Blood samples were collected at time 0 (fasting, and at 30, 60, 90, and 120 min postprandial, and were subsequently analyzed for glucose and insulin concentrations. Glucose response based on the incremental area under the curve showed a significant difference by treatment (p = 0.027. Changes in blood glucose concentrations were significantly different for the black bean meal and the chickpea meal in comparison to rice alone at 60 min (p = 0.026 and p = 0.024, 90 min (p = 0.001 and p = 0.012 and 120 min post prandial (p = 0.024; black bean meal. Findings indicate that combinations of black beans and chickpeas with white rice improve glycemic response, providing evidence that has promising implications for dietary guidance to reduce postprandial glucose and related health risks through traditional food patterns.

  13. Effectiveness of low-level laser therapy for patients with carpal tunnel syndrome: design of a randomized single-blinded controlled trial

    Directory of Open Access Journals (Sweden)

    Barbosa Rafael Inácio

    2012-12-01

    Full Text Available Abstract Background Carpal tunnel syndrome is the most common neuropathy in the upper extremity, resulting from the compression of the median nerve at wrist level. Clinical studies are essentials to present evidence on therapeutic resources use at early restoration on peripheral nerve functionality. Low-level laser therapy has been widely investigated in researches related to nerve regeneration. Therefore, it is suggested that the effect of low-level laser therapy associated with other conservative rehabilitation techniques may positively affect symptoms and overall hand function in compressive neuropathies such as carpal tunnel syndrome. The aim of this study is to evaluate the effectiveness of low-level laser therapy in addition to orthoses therapy and home orientations in patients with carpal tunnel syndrome. Methods/Design Patients older than 18 years old will be included, with clinical diagnosis of carpal tunnel syndrome, excluding comorbidies. A physiotherapist will conduct intervention, with a blinding evaluator. Randomization will be applied to allocate the patients in each group: with association or not to low-level laser therapy. All of them will be submitted to orthoses therapy and home orientations. Outcome will be assessed through: pain visual analogic scale, Semmes Weinstein monofilaments™ threshold sensibility test, Pinch Gauge™, Boston Carpal Tunnel Questionnaire and two point discrimination test. Discussion This paper describes the design of a randomized controlled trial, which aim to assess the effectiveness of conservative treatment added to low-level laser therapy for patients with carpal tunnel syndrome. Trial registration Brazilian Clinical Trials Registry (ReBec - 75ddtf / Universal Trial Number: U1111-1121-5184

  14. Effectiveness of low-level laser therapy for patients with carpal tunnel syndrome: design of a randomized single-blinded controlled trial

    Science.gov (United States)

    2012-01-01

    Background Carpal tunnel syndrome is the most common neuropathy in the upper extremity, resulting from the compression of the median nerve at wrist level. Clinical studies are essentials to present evidence on therapeutic resources use at early restoration on peripheral nerve functionality. Low-level laser therapy has been widely investigated in researches related to nerve regeneration. Therefore, it is suggested that the effect of low-level laser therapy associated with other conservative rehabilitation techniques may positively affect symptoms and overall hand function in compressive neuropathies such as carpal tunnel syndrome. The aim of this study is to evaluate the effectiveness of low-level laser therapy in addition to orthoses therapy and home orientations in patients with carpal tunnel syndrome. Methods/Design Patients older than 18 years old will be included, with clinical diagnosis of carpal tunnel syndrome, excluding comorbidies. A physiotherapist will conduct intervention, with a blinding evaluator. Randomization will be applied to allocate the patients in each group: with association or not to low-level laser therapy. All of them will be submitted to orthoses therapy and home orientations. Outcome will be assessed through: pain visual analogic scale, Semmes Weinstein monofilaments™ threshold sensibility test, Pinch Gauge™, Boston Carpal Tunnel Questionnaire and two point discrimination test. Discussion This paper describes the design of a randomized controlled trial, which aim to assess the effectiveness of conservative treatment added to low-level laser therapy for patients with carpal tunnel syndrome. Trial registration Brazilian Clinical Trials Registry (ReBec) - 75ddtf / Universal Trial Number: U1111-1121-5184 PMID:23237204

  15. Randomized double-blind placebo-controlled trial of sublingual immunotherapy in children with house dust mite allergy in primary care: study design and recruitment

    Directory of Open Access Journals (Sweden)

    de Jongste Johan C

    2008-10-01

    Full Text Available Abstract Background For respiratory allergic disorders in children, sublingual immunotherapy has been developed as an alternative to subcutaneous immunotherapy. Sublingual immunotherapy is more convenient, has a good safety profile and might be an attractive option for use in primary care. A randomized double-blind placebo-controlled study was designed to establish the efficacy of sublingual immunotherapy with house dust mite allergen compared to placebo treatment in 6 to18-year-old children with allergic rhinitis and a proven house dust mite allergy in primary care. Described here are the methodology, recruitment phases, and main characteristics of the recruited children. Methods Recruitment took place in September to December of 2005 and 2006. General practitioners (in south-west Netherlands selected children who had ever been diagnosed with allergic rhinitis. Children and parents could respond to a postal invitation. Children who responded positively were screened by telephone using a nasal symptom score. After this screening, an inclusion visit took place during which a blood sample was taken for the RAST test. Results A total of 226 general practitioners invited almost 6000 children: of these, 51% was male and 40% Conclusion Our study was designed in accordance with recent recommendations for research on establishing the efficacy of sublingual immunotherapy; 98% of the target sample size was achieved. This study is expected to provide useful information on sublingual immunotherapy with house dust mite allergen in primary care. The results on efficacy and safety are expected to be available by 2010. Trial registration the trial is registered as ISRCTN91141483 (Dutch Trial Register

  16. Agreement between touch-screen and paper-based patient-reported outcomes for patients with fibromyalgia: a randomized cross-over reproducibility study.

    Science.gov (United States)

    Wæhrens, E E; Amris, K; Bartels, E M; Christensen, R; Danneskiold-Samsøe, B; Bliddal, H; Gudbergsen, H

    2015-01-01

    To compare data based on computerized and paper versions of health status questionnaires (HSQs) for sampling patient-reported outcomes (PROs) in patients with fibromyalgia (FM). In addition, to examine associations between patient characteristics (age, education, computer experience) and differences between versions. Finally, to evaluate the acceptability of computer-based questionnaires among patients with FM. The study population comprised female patients diagnosed with FM. All patients completed six HSQs: the Fibromyalgia Impact Questionnaire (FIQ), the Major Depression Inventory (MDI), the 36-item Short Form Health Survey (SF-36), the painDETECT questionnaire (PDQ), the Coping Strategies Questionnaire (CSQ), and the Generalized Anxiety Disorder Self-Assessment Questionnaire (GAD-10), both on paper and using a touch screen. One HSQ was tested at a time in a repeated randomized cross-over design. The two versions were completed with a 5-min interval and between each HSQ the participants had a 5-min break. Means, mean differences with 95% confidence intervals (CIs), medians, median differences, and intraclass correlation coefficients (ICCs) were calculated for all HSQs, including relevant subscales. Associations between patient characteristics and differences between versions were explored using Spearman's correlation coefficients. Twenty women, mean age 48.4 years, participated in the study. Except for one item, ICCs between touch-screen and paper versions of the HSQs examined indicated acceptable agreement (ICC = 0.71-0.99). Overall, mean and median differences revealed no differences between versions. No significant associations were observed for patient characteristics. None of the participants preferred paper questionnaires over computerized versions. The computerized HSQs using a touch screen gave comparable results to answers given on paper and were generally preferred by the participants.

  17. User-centered Technologies For Blind Children

    Directory of Open Access Journals (Sweden)

    Jaime Sánchez

    2008-01-01

    Full Text Available The purpose of this paper is to review, summarize, and illustrate research work involving four audio-based games created within a user-centered design methodology through successive usability tasks and evaluations. These games were designed by considering the mental model of blind children and their styles of interaction to perceive and process data and information. The goal of these games was to enhance the cognitive development of spatial structures, memory, haptic perception, mathematical skills, navigation and orientation, and problem solving of blind children. Findings indicate significant improvements in learning and cognition from using audio-based tools specially tailored for the blind. That is, technologies for blind children, carefully tailored through user-centered design approaches, can make a significant contribution to cognitive development of these children. This paper contributes new insight into the design and implementation of audio-based virtual environments to facilitate learning and cognition in blind children.

  18. Commentary on: "Randomized, controlled, double-blind, cross-over trial assessing treatment preference for pazopanib versus sunitinib in patients with metastatic renal cell carcinoma: PISCES study." Escudier B, Porta C, Bono P, Powles T, Eisen T, Sternberg CN, Gschwend JE, De Giorgi U, Parikh O, Hawkins R, Sevin E, Négrier S, Khan S, Diaz J, Redhu S, Mehmud F, Cella D. Bernard Escudier, Institut Gustave Roussy, Villejuif; Emmanuel Sevin, Centre François Baclesse, Caen; Sylvie Négrier, Leon Berard Cancer Center, Lyon, France; Camillo Porta, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico S. Matteo, Pavia; Cora N Sternberg, San Camillo Forlanini Hospital, Rome; Ugo De Giorgi, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; Petri Bono, Helsinki University Central Hospital, Helsinki, Finland; Thomas Powles, Barts Experimental Cancer Medicine Centre, Barts Cancer Institute, Queen Mary University of London, London; Tim Eisen, Cambridge University Health Partners, Cambridge; Omi Parikh, Royal Preston Hospital, Lancashire; Robert Hawkins, Christie Cancer Research UK, Manchester; Sadya Khan, Jose Diaz, and Faisal Mehmud, GlaxoSmithKline, Uxbridge, United Kingdom; Jürgen E Gschwend, Klinikum Rechts der Isar der Technischen Universität München, Munich, Germany; Suman Redhu, GlaxoSmithKline, Collegeville, PA; David Cella, Northwestern University Feinberg School of Medicine, Chicago, IL.: J Clin Oncol. 2014 May 10;32(14):1412-1418; doi: 10.1200/JCO.2013.50.8267. [Epub 2014 Mar 31].

    Science.gov (United States)

    Trump, Donald

    2016-05-01

    Patient-reported outcomes may help inform treatment choice in advanced/metastatic renal cell carcinoma (RCC), particularly between approved targeted therapies with similar efficacy. This double-blind crossover study evaluated patient preference for pazopanib or sunitinib and the influence of health-related quality of life (HRQoL) and safety factors on their stated preference. Patients with metastatic renal cell carcinoma were randomly assigned to pazopanib 800mg per day for 10 weeks, a 2-week washout, and then sunitinib 50mg per day (4 weeks on, 2 weeks off, 4weeks on) for 10 weeks, or the reverse sequence. The primary end point, patient preference for a specific treatment, was assessed by questionnaire at the end of the two treatment periods. Other end points and analyses included reasons for preference, physician preference, safety, and HRQoL. Of 169 randomly assigned patients, 114 met the following prespecified modified intent-to-treat criteria for the primary analysis: exposure to both treatments, no disease progression before cross over, and completion of the preference questionnaire. Significantly more patients preferred pazopanib (70%) over sunitinib (22%); 8% expressed no preference (P<.001). All preplanned sensitivity analyses, including the intent-to-treat population, statistically favored pazopanib. Less fatigue and better overall quality of life were the main reasons for preferring pazopanib, with less diarrhea being the most cited reason for preferring sunitinib. Physicians also preferred pazopanib (61%) over sunitinib (22%); 17% expressed no preference. Adverse events were consistent with each drug׳s known profile. Pazopanib was superior to sunitinib in HRQoL measures evaluating fatigue, hand/foot soreness, and mouth/throat soreness. This innovative crossover trial demonstrated a significant patient preference for pazopanib over sunitinib, with HRQoL and safety as key influencing factors. Copyright © 2016 Elsevier Inc. All rights reserved.

  19. Effect of almond consumption on vascular function in patients with coronary artery disease: a randomized, controlled, cross-over trial.

    Science.gov (United States)

    Chen, C-Y Oliver; Holbrook, Monika; Duess, Mai-Ann; Dohadwala, Mustali M; Hamburg, Naomi M; Asztalos, Bela F; Milbury, Paul E; Blumberg, Jeffrey B; Vita, Joseph A

    2015-06-17

    Almonds reduce cardiovascular disease risk via cholesterol reduction, anti-inflammation, glucoregulation, and antioxidation. The objective of this randomized, controlled, cross-over trial was to determine whether the addition of 85 g almonds daily to a National Cholesterol Education Program (NCEP) Step 1 diet (ALM) for 6 weeks would improve vascular function and inflammation in patients with coronary artery disease (CAD). A randomized, controlled, crossover trial was conducted in Boston, MA to test whether as compared to a control NCEP Step 1 diet absent nuts (CON), incorporation of almonds (85 g/day) into the CON diet (ALM) would improve vascular function and inflammation. The study duration was 22 weeks including a 6-weeks run-in period, two 6-weeks intervention phases, and a 4-weeks washout period between the intervention phases. A total of 45 CAD patients (27 F/18 M, 45-77 y, BMI = 20-41 kg/m(2)) completed the study. Drug therapies used by patients were stable throughout the duration of the trial. The addition of almonds to the CON diet increased plasma α-tocopherol status by a mean of 5.8%, reflecting patient compliance (P ≤0.05). However, the ALM diet did not alter vascular function assessed by measures of flow-mediated dilation, peripheral arterial tonometry, and pulse wave velocity. Further, the ALM diet did not significantly modify the serum lipid profile, blood pressure, C-reactive protein, tumor necrosis factor-α or E-selectin. The ALM diet tended to decrease vascular cell adhesion molecule-1 by 5.3% (P = 0.064) and increase urinary nitric oxide by 17.5% (P = 0.112). The ALM intervention improved the overall quality of the diet by increasing calcium, magnesium, choline, and fiber intakes above the Estimated Average Requirement (EAR) or Recommended Dietary Allowance (RDA). Thus, the addition of almonds to a NECP Step 1 diet did not significantly impact vascular function, lipid profile or systematic inflammation in CAD patients receiving

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

    Science.gov (United States)

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

    2013-11-01

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

  1. What is Color Blindness?

    Science.gov (United States)

    ... Stories Español Eye Health / Eye Health A-Z Color Blindness Sections What Is Color Blindness? What Are ... Treatment How Color Blindness Is Tested What Is Color Blindness? Leer en Español: ¿Qué es el daltonismo? ...

  2. UVB phototherapy in an outpatient setting or at home: a pragmatic randomised single-blind trial designed to settle the discussion. The PLUTO study.

    Science.gov (United States)

    Koek, Mayke B G; Buskens, Erik; Steegmans, Paul H A; van Weelden, Huib; Bruijnzeel-Koomen, Carla A F M; Sigurdsson, Vigfús

    2006-08-01

    Home ultraviolet B (UVB) treatment is a much-debated treatment, especially with regard to effectiveness, safety and side effects. However, it is increasingly being prescribed, especially in the Netherlands. Despite ongoing discussions, no randomised research has been performed, and only two studies actually compare two groups of patients. Thus, firm evidence to support or discourage the use of home UVB phototherapy has not yet been obtained. This is the goal of the present study, the PLUTO study (Dutch acronym for "national trial on home UVB phototherapy for psoriasis"). We designed a pragmatic randomised single-blind multi-centre trial. This trial is designed to evaluate the impact of home UVB treatment versus UVB phototherapy in a hospital outpatient clinic as to effectiveness, quality of life and cost-effectiveness. In total 196 patients with psoriasis who were clinically eligible for UVB phototherapy were included. Normally 85% of the patients treated with UVB show a relevant clinical response. With a power of 80% and a 0.05 significance level it will be possible to detect a reduction in effectiveness of 15%. Effectiveness will be determined by calculating differences in the Psoriasis Area and Severity Index (PASI) and the Self Administered PASI (SAPASI) scores. Quality of life is measured using several validated generic questionnaires and a disease-specific questionnaire. Other outcome measures include costs, side effects, dosimetry, concomitant use of medication and patient satisfaction. Patients are followed throughout the therapy and for 12 months thereafter. The study is no longer recruiting patients, and is expected to report in 2006. In the field of home UVB phototherapy this trial is the first randomised parallel group study. As such, this trial addresses the weaknesses encountered in previous studies. The pragmatic design ensures that the results can be well generalised to the target population. Because, in addition to effectiveness, aspects such as

  3. UVB phototherapy in an outpatient setting or at home: a pragmatic randomised single-blind trial designed to settle the discussion. The PLUTO study

    Directory of Open Access Journals (Sweden)

    van Weelden Huib

    2006-08-01

    Full Text Available Abstract Background Home ultraviolet B (UVB treatment is a much-debated treatment, especially with regard to effectiveness, safety and side effects. However, it is increasingly being prescribed, especially in the Netherlands. Despite ongoing discussions, no randomised research has been performed, and only two studies actually compare two groups of patients. Thus, firm evidence to support or discourage the use of home UVB phototherapy has not yet been obtained. This is the goal of the present study, the PLUTO study (Dutch acronym for "national trial on home UVB phototherapy for psoriasis". Methods We designed a pragmatic randomised single-blind multi-centre trial. This trial is designed to evaluate the impact of home UVB treatment versus UVB phototherapy in a hospital outpatient clinic as to effectiveness, quality of life and cost-effectiveness. In total 196 patients with psoriasis who were clinically eligible for UVB phototherapy were included. Normally 85% of the patients treated with UVB show a relevant clinical response. With a power of 80% and a 0.05 significance level it will be possible to detect a reduction in effectiveness of 15%. Effectiveness will be determined by calculating differences in the Psoriasis Area and Severity Index (PASI and the Self Administered PASI (SAPASI scores. Quality of life is measured using several validated generic questionnaires and a disease-specific questionnaire. Other outcome measures include costs, side effects, dosimetry, concomitant use of medication and patient satisfaction. Patients are followed throughout the therapy and for 12 months thereafter. The study is no longer recruiting patients, and is expected to report in 2006. Discussion In the field of home UVB phototherapy this trial is the first randomised parallel group study. As such, this trial addresses the weaknesses encountered in previous studies. The pragmatic design ensures that the results can be well generalised to the target population

  4. Treatment of Palmar Hyperhidrosis with Tap Water Iontophoresis: A Randomized, Sham-Controlled, Single-Blind, and Parallel-Designed Clinical Trial.

    Science.gov (United States)

    Kim, Do Hun; Kim, Tae Han; Lee, Seung Ho; Lee, Ai Young

    2017-12-01

    Palmar hyperhidrosis is a common disorder of excessive sweating. A number of studies have demonstrated the effectiveness of iontophoresis in the treatment of palmar hyperhidrosis. However, controlled clinical studies on iontophoresis for palmar hyperhidrosis have been limited. To determine the efficacy and safety of iontophoresis in the treatment of palmar hyperhidrosis with a randomized, sham-controlled, single-blind, and parallel-designed study. Twenty nine patients with significant palmar hyperhidrosis were enrolled in this study. They received active iontophoresis treatment (group A) or sham treatment (group B). Iontophoresis was performed 20 minutes each time, five times per week, for 2 weeks. Its efficacy was assessed with starch-iodine test, mean sweat secretion rate, and hyperhidrosis disease severity scale. Twenty-seven of the 29 patients completed the 2-week treatment. After completion of 10 times of treatment, results of the starch-iodine test showed clinical improvement in 92.9% of patients in group A and 38.5% of patients in group B ( p =0.001). The mean sweat secretion rate was reduced by 91.8% of patients in group A and by 39.1% of patients in group B ( p <0.001). Improvement in quality of life was reported by 78.6% of patients in group A and by 30.8% of patients in group B ( p =0.028). In group A, one case of localized adverse event was noted, although no adverse event was encountered in group B. Tap water iontophoresis could be used as an effective and safe treatment modality for palmar hyperhidrosis.

  5. Towards evidence-based vitamin D supplementation in infants: vitamin D intervention in infants (VIDI) - study design and methods of a randomised controlled double-blinded intervention study.

    Science.gov (United States)

    Helve, Otto; Viljakainen, Heli; Holmlund-Suila, Elisa; Rosendahl, Jenni; Hauta-Alus, Helena; Enlund-Cerullo, Maria; Valkama, Saara; Heinonen, Kati; Räikkönen, Katri; Hytinantti, Timo; Mäkitie, Outi; Andersson, Sture

    2017-03-29

    Vitamin D is important for bone mass accrual during growth. Additionally, it is considered a requirement for a multitude of processes associated with, for example, the development of immunity. Many countries apply vitamin D supplementation strategies in infants, but the guidelines are not based on scientific evidence and aim at prevention of rickets. It remains unclear whether the recommended doses are sufficient for the wide array of other effects of vitamin D. The VIDI trial performed in Finland is the first large randomised controlled study for evaluation of the effects of different vitamin D supplemental doses in infancy on: 1. bone strength 2. infections and immunity 3. allergy, atopy and asthma 4. cognitive development 5. genetic regulation of mineral homeostasis METHODS/DESIGN: VIDI, a randomised controlled double-blinded single-centre intervention study is conducted in infants from the age of 2 weeks to 24 months. Participants, recruited at Helsinki Maternity Hospital, are randomised to receive daily either 10 μg (400 IU) or 30 μg (1 200 IU) of vitamin D3 supplementation. Both groups are assessed at 6 months of age for calcium homeostasis, and at 12 and 24 months of age for parameters associated with bone strength, growth, developmental milestones, infections, immunity, atopy-related diseases, and genetic factors involved in these functions. The study enables evaluation of short and long term effects of supplemental vitamin D on growth, immune functions and skeletal and developmental parameters in infants, and the effects of genetic factors therein. The results enable institution of evidence-based guidelines for vitamin D supplementation in infancy. ClinicalTrials.gov, NCT01723852 , registration date 6.11.2012.

  6. Effectiveness of intramuscular corticosteroid injection versus placebo injection in patients with hip osteoarthritis: design of a randomized double-blinded controlled trial

    Directory of Open Access Journals (Sweden)

    Dorleijn Desirée MJ

    2011-12-01

    Full Text Available Abstract Background Recent international guidelines recommend intra-articular corticosteroid injections for patients with hip osteoarthritis who have moderate to severe pain and do not respond satisfactorily to oral analgesic/anti-inflammatory agents. Of the five available randomized controlled trials, four showed positive effects with respect to pain reduction. However, intra-articular injection in the hip is complex because the joint is adjacent to important neurovascular structures and cannot be palpated. Therefore fluoroscopic or ultrasound guidance is needed. The systemic effect of corticosteroids has been studied in patients with impingement shoulder pain. Gluteal corticosteroid injection was almost as effective as ultrasound-guided subacromial corticosteroid injection. Such a clinically relevant effect of a systemic corticosteroid injection offers a less complex alternative for treatment of patients with hip osteoarthritis not responsive to oral pain medication. Methods/Design This is a double-blinded, randomized controlled trial. A total of 135 patients (aged > 40 years with hip osteoarthritis and persistent pain despite oral analgesics visiting a general practitioner or orthopaedic surgeon will be included. They will be randomized to a gluteal intramuscular corticosteroid injection or a gluteal intramuscular placebo (saline injection. The randomization will be stratified for setting (general practitioner and outpatient clinics of department of orthopaedics. Treatment effect will be evaluated by questionnaires at 2, 4, 6, and 12 weeks follow-up and a physical examination at 12 weeks. Primary outcome is severity of hip pain reported by the patients at 2-week follow-up. Statistical analyses will be based on the intention-to-treat principle. Discussion This study will evaluate the effectiveness of an intramuscular corticosteroid injection on pain in patients with hip osteoarthritis. Patient recruitment has started. Trial Registration This

  7. Concepts about Print for the Young Blind Child.

    Science.gov (United States)

    Language Arts, 1982

    1982-01-01

    Provides teachers with an understanding of how sighted children develop concepts about print and how blind children develop concepts about braille. Prereading activities designed to extend young children's concepts about print are adapted for blind children. (HTH)

  8. Plasma exchange combined with azathioprine in multiple sclerosis using serial gadolinium-enhanced MRI to monitor disease activity: a randomized single-masked cross-over pilot study

    DEFF Research Database (Denmark)

    Sørensen, P.S.; Wanscher, B; Szpirt, W

    1996-01-01

    We enrolled 11 patients with secondary progressive MS in a randomized single-masked cross-over study of plasma exchange (PE) in combination with azathioprine 2 mg/kg. PE was performed once a week for 4 weeks and thereafter every second week for 20 weeks (14 treatments). Eight patients completed...

  9. Cost-effectiveness of antibiotic treatment strategies for community-acquired pneumonia : results from a cluster randomized cross-over trial

    NARCIS (Netherlands)

    van Werkhoven, Cornelis H; Postma, Douwe F; Mangen, Marie-Josee J; Oosterheert, Jan Jelrik; Bonten, Marc J M

    2017-01-01

    BACKGROUND: To determine the cost-effectiveness of strategies of preferred antibiotic treatment with beta-lactam/macrolide combination or fluoroquinolone monotherapy compared to beta-lactam monotherapy. METHODS: Costs and effects were estimated using data from a cluster-randomized cross-over trial

  10. Randomized cross-over study of patient preference for oral or intravenous vinorelbine in combination with carboplatin in the treatment of advanced NSCLC

    DEFF Research Database (Denmark)

    Jensen, Lisa Helene Toft; Østerlind, Kell Erik; Rytter, C.

    2008-01-01

    treatment of non-small cell lung cancer (NSCLC). Secondary aims were to evaluate toxicity, efficacy, and subjective reasons the preference. PATIENTS AND METHODS: Sixty-one patients were randomized in a cross-over trial to two cycles of carboplatin day 1 and vinorelbine day 1 and day 8 iv followed by two...

  11. Design of a randomized controlled double-blind crossover clinical trial to assess the effects of saliva substitutes on bovine enamel and dentin in situ

    Directory of Open Access Journals (Sweden)

    Kielbassa Andrej M

    2011-04-01

    Full Text Available Abstract Background Hyposalivation is caused by various syndromes, diabetes, drugs, inflammation, infection, or radiotherapy of the salivary glands. Patients with hyposalivation often show an increased caries incidence. Moreover, hyposalivation is frequently accompanied by oral discomfort and impaired oral functions, and saliva substitutes are widely used to alleviate oral symptoms. However, preference of saliva substitutes due to taste, handling, and relief of oral symptoms has been discussed controversially. Some of the marketed products have shown demineralizing effects on dental hard tissues in vitro. This demineralizing potential is attributed to the undersaturation with respect to calcium phosphates. Therefore, it is important to modify the mineralizing potential of saliva substitutes to prevent carious lesions. Thus, the aim of the present study was to evaluate the effects of a possible remineralizing saliva substitute (SN; modified Saliva natura compared to a demineralizing one (G; Glandosane on mineral parameters of sound bovine dentin and enamel as well as on artificially demineralized enamel specimens in situ. Moreover, oral well-being after use of each saliva substitute was recorded. Methods/Design Using a randomized, double-blind, crossover, phase II/III in situ trial, volunteers with hyposalivation utilize removable dentures containing bovine specimens during the experimental period. The volunteers are divided into two groups, and are required to apply both saliva substitutes for seven weeks each. After both test periods, differences in mineral loss and lesion depth between values before and after exposure are evaluated based on microradiographs. The oral well-being of the volunteers before and after therapy is determined using questionnaires. With respect to the microradiographic analysis, equal mineral losses and lesion depths of enamel and dentin specimens during treatment with SN and G, and no differences in patients

  12. Rationale and design of a multicenter placebo-controlled double-blind randomized trial to evaluate the effect of empagliflozin on endothelial function: the EMBLEM trial.

    Science.gov (United States)

    Tanaka, Atsushi; Shimabukuro, Michio; Okada, Yosuke; Taguchi, Isao; Yamaoka-Tojo, Minako; Tomiyama, Hirofumi; Teragawa, Hiroki; Sugiyama, Seigo; Yoshida, Hisako; Sato, Yasunori; Kawaguchi, Atsushi; Ikehara, Yumi; Machii, Noritaka; Maruhashi, Tatsuya; Shima, Kosuke R; Takamura, Toshinari; Matsuzawa, Yasushi; Kimura, Kazuo; Sakuma, Masashi; Oyama, Jun-Ichi; Inoue, Teruo; Higashi, Yukihito; Ueda, Shinichiro; Node, Koichi

    2017-04-12

    Type 2 diabetes mellitus (T2DM) is characterized by systemic metabolic abnormalities and the development of micro- and macrovascular complications, resulting in a shortened life expectancy. A recent cardiovascular (CV) safety trial, the EMPA-REG OUTCOME trial, showed that empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, markedly reduced CV death and all-cause mortality and hospitalization for heart failure in patients with T2DM and established CV disease (CVD). SGLT2 inhibitors are known to not only decrease plasma glucose levels, but also favorably modulate a wide range of metabolic and hemodynamic disorders related to CV pathways. Although some experimental studies revealed a beneficial effect of SGLT2 inhibitors on atherosclerosis, there is a paucity of clinical data showing that they can slow the progression of atherosclerosis in patients with T2DM. Therefore, the EMBLEM trial was designed to investigate whether empagliflozin treatment can improve endothelial function, which plays a pivotal role in the pathogenesis of atherosclerosis, in patients with T2DM and established CVD. The EMBLEM trial is an ongoing, prospective, multicenter, placebo-controlled double-blind randomized, investigator-initiated clinical trial in Japan. A total of 110 participants with T2DM (HbA1c range 6.0-10.0%) and with established CVD will be randomized (1:1) to receive either empagliflozin 10 mg once daily or a placebo. The primary endpoint of the trial is change in the reactive hyperemia (RH)-peripheral arterial tonometry-derived RH index at 24 weeks from baseline. For comparison of treatment effects between the treatment groups, the baseline-adjusted means and their 95% confidence intervals will be estimated by analysis of covariance adjusted for the following allocation factors: HbA1c (EMBLEM is the first trial to assess the effect of empagliflozin on endothelial function in patients with T2DM and established CVD. Additionally, mechanisms associating

  13. Psychological and social adjustment to blindness: Understanding ...

    African Journals Online (AJOL)

    2011-06-15

    Jun 15, 2011 ... a pro forma designed by the authors to assess the psychosocial problems and risk factors in some blind people in. Ilorin metropolis. .... visually impaired.[29]. Ideally for any blind patient, the eye doctor should look for maladjustment in social-economic functioning (unemployment, difficulty in unaided mobility ...

  14. Explicit feedback to enhance the effect of an interim assessment: a cross-over study on learning effect and gender difference.

    Science.gov (United States)

    Olde Bekkink, Marleen; Donders, Rogier; van Muijen, Goos N P; de Waal, Rob M W; Ruiter, Dirk J

    2012-11-01

    In a previous study we demonstrated by a prospective controlled design that an interim assessment during an ongoing small group work (SGW) session resulted in a higher score in the course examination. As this reflects the so-called testing effect, which is supposed to be enhanced by feedback, we investigated whether feedback following an interim assessment would have an effect on the score of the course exam, and whether the effect is influenced by the gender of the student. During a General Pathology bachelor course all 386 (bio) medical students took an interim assessment on the topics cell damage (first week) and tumour pathology (fourth week). The intervention consisted of immediate detailed oral feedback on the content of the questions of the interim assessment by the tutor, including the rationale of the correct and incorrect answers. It concerned a prospective randomized study using a cross-over design. Outcome measures were: (1) the difference in the normalized scores (1-10) of the course examination multiple choice questions related to the two topics, (2) effect of gender, and (3) gender-specific scores on formal examination. The effect of feedback was estimated as half the difference in the outcome between the two conditions. Mixed-model analysis was used whereby the SGW group was taken as the study target. The scores of the questions on cell damage amounted to 7.70 (SD 1.59) in the group without and 7.78 (SD 1.39) in the group with feedback, and 6.73 (SD 1.51) and 6.77 (SD 1.60), respectively, for those on tumour pathology. No statistically significant effect of feedback was found: 0.02 on a scale of 1-10 (95 % CI: -0.20; 0.25). There were no significant interactions of feedback with gender. Female students scored 0.43 points higher on the formal examination in comparison with their male colleagues. No additional effect of immediate explicit feedback following an interim assessment during an SGW session in an ongoing bachelor course could be

  15. Kinesio Taping vs. Placebo in Reducing Pregnancy-Related Low Back Pain: A Cross-Over Study

    Science.gov (United States)

    Kalinowski, Paweł; Krawulska, Anna

    2017-01-01

    Background Spinal pain affects approximately 45–56% of pregnant women. Kinesio taping (KT) involves application of flexible water-resistant elastic bands on the patient’s body, resulting in painless and non-invasive stimulation. The aim of the study was to determine the influence of KT on reduction of low back pain in pregnant women. Material/Methods Kinesio Tex Gold tapes were applied using the muscular-ligament technique and Polovis Plus textile cladding blinded the sample. The starting position for the KT and placebo with lumbar spine flexion with rotation was in the opposite direction to the application. An “I”-shaped application was used. The material included 106 women in the second and third trimesters of pregnancy, with low back pain. The Visual Analogue Scale (VAS) and the Polish version of the Roland Morris Disability Questionnaire (RMDQ-2004) were used for pain assessment. Participants were randomly divided into 2 groups. KT and placebo were used alternately in 2 groups. Results Mean pain intensity on the 2nd and 7th post-application days was significantly lower in the study group than in the control group. Mean scores for the RMDQ differed significantly before and after KT (ptape. The few side effects did not affect the course of the study. PMID:29277836

  16. Effect of high-flow nasal therapy during acute aerobic exercise in patients with chronic obstructive pulmonary disease after exacerbation: protocol for a randomised, controlled, cross-over trial.

    Science.gov (United States)

    Prieur, Guillaume; Medrinal, Clement; Combret, Yann; Quesada, Aurora Robledo; Prieur, Fabrice; Quieffin, Jean; Borel, Jean Christian; Reychler, Gregory

    2017-01-01

    Early pulmonary rehabilitation is recommended after a severe exacerbation of chronic obstructive pulmonary disease (COPD). However, this is difficult to implement, particularly for exercise training. High-flow nasal therapy (HFNT) may reduce the work of breathing and dyspnoea and may improve exercise tolerance. This is a single-centre, prospective, controlled, randomised, cross-over study. Eligible patients will have a diagnosis of COPD (postbronchodilator forced expiratory volume in 1 s/forced vital capacity ratio of muscle oxygenation during exercise, dyspnoea and muscle fatigue, respiratory muscle strength after exercise, respiratory rate, cardiac frequency, transcutaneous CO 2 pressure and pulsed O 2 saturation. Nineteen patients will be included. Data will be analysed as intention to treat by a blinded statistician. Ethics approval has been obtained from the Ethics Committees Nord-Ouest III, Caen, France (N° ID RCB: 2016-A01325-46). The study will begin in April 2017 for a duration of 2 years. The results of the trial will be presented at national and international meetings and published in peer-reviewed journals. NCT03058081.

  17. Representing vision and blindness.

    Science.gov (United States)

    Ray, Patrick L; Cox, Alexander P; Jensen, Mark; Allen, Travis; Duncan, William; Diehl, Alexander D

    2016-01-01

    There have been relatively few attempts to represent vision or blindness ontologically. This is unsurprising as the related phenomena of sight and blindness are difficult to represent ontologically for a variety of reasons. Blindness has escaped ontological capture at least in part because: blindness or the employment of the term 'blindness' seems to vary from context to context, blindness can present in a myriad of types and degrees, and there is no precedent for representing complex phenomena such as blindness. We explore current attempts to represent vision or blindness, and show how these attempts fail at representing subtypes of blindness (viz., color blindness, flash blindness, and inattentional blindness). We examine the results found through a review of current attempts and identify where they have failed. By analyzing our test cases of different types of blindness along with the strengths and weaknesses of previous attempts, we have identified the general features of blindness and vision. We propose an ontological solution to represent vision and blindness, which capitalizes on resources afforded to one who utilizes the Basic Formal Ontology as an upper-level ontology. The solution we propose here involves specifying the trigger conditions of a disposition as well as the processes that realize that disposition. Once these are specified we can characterize vision as a function that is realized by certain (in this case) biological processes under a range of triggering conditions. When the range of conditions under which the processes can be realized are reduced beyond a certain threshold, we are able to say that blindness is present. We characterize vision as a function that is realized as a seeing process and blindness as a reduction in the conditions under which the sight function is realized. This solution is desirable because it leverages current features of a major upper-level ontology, accurately captures the phenomenon of blindness, and can be

  18. In-situ determination of cross-over point for overcoming plasma-related matrix effects in inductively coupled plasma-atomic emission spectrometry

    International Nuclear Information System (INIS)

    Chan, George C.-Y.; Hieftje, Gary M.

    2008-01-01

    A novel method is described for overcoming plasma-related matrix effects in inductively coupled plasma-atomic emission spectrometry (ICP-AES). The method is based on measurement of the vertically resolved atomic emission of analyte within the plasma and therefore requires the addition of no reagents to the sample solution or to the plasma. Plasma-related matrix effects enhance analyte emission intensity low in the plasma but depress the same emission signal at higher positions. Such bipolar behavior is true for all emission lines and matrices that induce plasma-related interferences. The transition where the enhancement is balanced by the depression (the so-called cross-over point) results in a spatial region with no apparent matrix effects. Although it would be desirable always to perform determinations at this cross-over point, its location varies between analytes and from matrix to matrix, so it would have to be found separately for every analyte and for every sample. Here, a novel approach is developed for the in-situ determination of the location of this cross-over point. It was found that the location of the cross-over point is practically invariant for a particular analyte emission line when the concentration of the matrix was varied. As a result, it is possible to determine in-situ the location of the cross-over point for all analyte emission lines in a sample by means of a simple one-step sample dilution. When the original sample is diluted by a factor of 2 and the diluted sample is analyzed again, the extent of the matrix effect is identical (zero) between the original sample and the diluted sample at one and only one location - the cross-over point. This novel method was verified with several single-element matrices (0.05 M Na, Ca, Ba and La) and some mixed-element matrices (mixtures of Na-Ca, Ca-Ba, and a plant-sample digest). The inaccuracy in emission intensity due to the matrix effect could be as large as - 30% for conventional measurements in the

  19. Mirroring everyday clinical practice in clinical trial design: a new concept to improve the external validity of randomized double-blind placebo-controlled trials in the pharmacological treatment of major depression

    Directory of Open Access Journals (Sweden)

    Severus Emanuel

    2012-07-01

    Full Text Available Abstract Background Randomized, double-blind, placebo-controlled trials constitute the gold standard in clinical research when testing the efficacy of new psychopharmacological interventions in the treatment of major depression. However, the blinded use of placebo has been found to influence clinical trial outcomes and may bias patient selection. Discussion To improve clinical trial design in major depression so as to reflect clinical practice more closely we propose to present patients with a balanced view of the benefits of study participation irrespective of their assignment to placebo or active treatment. In addition every participant should be given the option to finally receive the active medication. A research agenda is outlined to evaluate the impact of the proposed changes on the efficacy of the drug to be evaluated and on the demographic and clinical characteristics of the enrollment fraction with regard to its representativeness of the eligible population. Summary We propose a list of measures to be taken to improve the external validity of double-blind, placebo-controlled trials in major depression. The recommended changes to clinical trial design may also be relevant for other psychiatric as well as medical disorders in which expectations regarding treatment outcome may affect the outcome itself.

  20. A pilot double-blind, randomized, placebo-controlled trial of the efficacy of trace elements in the treatment of endometriosis-related pain: study design and methodology

    Directory of Open Access Journals (Sweden)

    Oberweis D

    2016-02-01

    Full Text Available Didier Oberweis,1 Patrick Madelenat,2 Michelle Nisolle,3 Etienne Demanet4 1Department of Gynecology and Obstetrics, CHU de Charleroi, Hôpital André Vésale, Montigny-le-Tilleul, Belgium; 2Private Consultation, Paris, France; 3Department of Gynecology and Obstetrics, CHR Citadelle, Liège, 4Clinical Research Unit, Charleroi, Belgium Abstract: Endometriosis is one of the most common benign gynecological disorders, affecting almost 10%–15% of all women of reproductive age and >30% of infertile women. The pathology is associated with various distressing symptoms, particularly pelvic pain, which adversely affect patients' quality of life. It is an estrogen-dependent disease. There is evidence both in animals and in humans that metal ions can activate the estrogen receptors. They are defined as a variety of xenoestrogens, called metalloestrogens, which could act as endocrine disruptors. Therefore, it could be considered to act on this gynecological disorder using food supplements containing trace elements (ie, nutripuncture. The assumption is that they could modulate estrogen receptors and thus influence the tropism and the survival of cells involved in endometriosis. By a modulation of the antioxidant system, they might also interact with various parameters influencing tissue biochemistry. The objective of this article is to describe and discuss the design and methodology of an ongoing double-blind, randomized, placebo-controlled study aiming to evaluate the efficacy of metal trace elements on the reduction of pain and improvement of quality of life, in patients with a revised American Fertility Society Score Stages II–IV endometriosis, combined or not with adenomyosis, during a treatment period of 4 months. Trace elements or placebo is proposed in the absence of any other treatment or as an add-on to current therapies, such as sexual hormones, nonsteroidal anti-inflammatory drugs, and surgery. A placebo run-in period of one menstrual cycle or

  1. Lactic-fermented egg white reduced serum cholesterol concentrations in mildly hypercholesterolemic Japanese men: a double-blind, parallel-arm design.

    Science.gov (United States)

    Matsuoka, Ryosuke; Usuda, Mika; Masuda, Yasunobu; Kunou, Masaaki; Utsunomiya, Kazunori

    2017-05-30

    Lactic-fermented egg white (LE), produced by lactic acid fermentation of egg white, is an easy-to-consume form of egg white. Here we assessed the effect of daily consumption of LE for 8 weeks on serum total cholesterol (TC) levels. The study followed a double-blind, parallel-arm design and included 88 adult men with mild hypercholesterolemia (mean ± standard error) serum TC levels, 229 ± 1.6 mg/dL; range, 204-259 mg/dL). The subjects were randomly divided into three groups, which consumed LE containing 4, 6, or 8 g of protein daily for 8 weeks. Blood samples were collected before starting LE consumption (baseline) and at 4 and 8 weeks to measure serum TC and low-density lipoprotein cholesterol (LDL-C) levels. After 8 weeks of consumption, serum TC levels in the 8 g group decreased by 11.0 ± 3.7 mg/dL, a significant decrease compared to baseline (p < 0.05) and a significantly greater decrease than for the 4 g group (3.1 ± 3.4 mg/dL; p < 0.05). Serum LDL-C levels in the 8 g group decreased by 13.7 ± 3.1 mg/dL, again a significant decrease compared with baseline (p < 0.05) and a significantly greater decrease than that for the 4 g group (2.1 ± 2.9 mg/dL; p < 0.05). Consumption of LE for 8 weeks at a daily dose of 8 g of proteins reduced serum TC and LDL-C levels in men with mild hypercholesterolemia, suggesting this may be effective in helping to prevent arteriosclerotic diseases. This clinical trial was retrospectively registered with the Japan Medical Association Center for Clinical Trials, (JMA-IIA00279; registered on 13/03/2017; https://dbcentre3.jmacct.med.or.jp/JMACTR/App/JMACTRE02_04/JMACTRE02_04.aspx?kbn=3&seqno=6530 ).

  2. The impact of a multidisciplinary self-care management program on quality of life, self-care, adherence to anti-hypertensive therapy, glycemic control, and renal function in diabetic kidney disease: A Cross-over Study Protocol.

    Science.gov (United States)

    Helou, Nancy; Talhouedec, Dominique; Shaha, Maya; Zanchi, Anne

    2016-07-19

    Diabetic kidney disease, a global health issue, remains associated with high morbidity and mortality. Previous research has shown that multidisciplinary management of chronic disease can improve patient outcomes. The effect of multidisciplinary self-care management on quality of life and renal function of patients with diabetic kidney disease has not yet been well established. The aim of this study is to evaluate the impact of a multidisciplinary self-care management program on quality of life, self-care behavior, adherence to anti-hypertensive treatment, glycemic control, and renal function of adults with diabetic kidney disease. A uniform balanced cross-over design is used, with the objective to recruit 40 adult participants with diabetic kidney disease, from public and private out-patient settings in French speaking Switzerland. Participants are randomized in equal number into four study arms. Each participant receives usual care alternating with the multidisciplinary self- care management program. Each treatment period lasts three months and is repeated twice at different time intervals over 12 months depending on the cross-over arm. The multidisciplinary self-care management program is led by an advanced practice nurse and adds nursing and dietary consultations and follow-ups, to the habitual management provided by the general practitioner, the nephrologist and the diabetologist. Data is collected every three months for 12 months. Quality of life is measured using the Audit of Diabetes-Dependent Quality of Life scale, patient self-care behavior is assessed using the Revised Summary of Diabetes Self-Care Activities, and adherence to anti-hypertensive therapy is evaluated using the Medication Events Monitoring System. Blood glucose control is measured by the glycated hemoglobin levels and renal function by serum creatinine, estimated glomerular filtration rate and urinary albumin/creatinine ratio. Data will be analyzed using STATA version 14. The cross-over

  3. Effects of visual illusion and transcutaneous electrical nerve stimulation on neuropathic pain in patients with spinal cord injury: A randomised controlled cross-over trial.

    Science.gov (United States)

    Özkul, Çağla; Kılınç, Muhammed; Yıldırım, Sibel Aksu; Topçuoğlu, Elif Yalçın; Akyüz, Müfit

    2015-01-01

    Chronic pain is a common consequence of spinal cord injury (SCI). No therapeutic drugs or drug groups are proven to be superior for neuropathic pain and treatments only aim to convert pain from dull to tolerable levels and not to remove it. This study was planned to compare the effect of visual illusion (VI) and transcutaneous electrical nerve stimulation (TENS) on pain intensity, pain quality and functional capacity in SCI patients with neuropathic pain. Twenty-four patients were included and randomly categorized into two groups. In the first group (n= 12), visual illusion was applied for first two weeks, 1 week wash out period and then TENS was applied for 2 weeks. In second group (n= 12), TENS was applied firstly, 1 week wash out and then %visual illusion VI were applied. Pain severity, pain quality, and functional capacity were assessed with the visual analog scale (VAS), the neuropathic pain scale (NPS), and the brief pain inventory (BPI), respectively. A pre-post-treatment and cross over design was used. Wilcoxon signed-rank tests were used for within group analyses. Mann-Whitney U tests were used for analyses that compared different groups. It was observed that pain intensity decrease immediately after both applications (VI: p= 0.07, TENS: p= 0.08). After TENS application for 2 weeks, it was observed that significant decrease in most (p= 0.04) and less (p= 0.02) pain intensity; while there was no significant decrease in pain intensity after 2 weeks for VI (p> 0.05). When findings of NPS were analyzed, hot (p= 0.047), sharp (p= 0.02), unpleasant (p= 0.03) and deep items (p= 0.047) decreased after VI application. When the results of BPI were detected, they were observed that the negative effect of pain on moving ability (p= 0.04) after visual illusion application and the negative effect of pain on mood (p= 0.03), relationships with others (p= 0.04) and sleep (p= 0.04) after TENS application decreased significantly. TENS and VI therapies can be successfully

  4. A randomized cross-over study of the quality of cardiopulmonary resuscitation among females performing 30:2 and hands-only cardiopulmonary resuscitation

    Directory of Open Access Journals (Sweden)

    Patrickson W Clive

    2009-07-01

    Full Text Available Abstract Background Hands-Only cardiopulmonary resuscitation (CPR is recommended for use on adult victims of witnessed out-of-hospital (OOH sudden cardiac arrest or in instances where rescuers cannot perform ventilations while maintaining minimally interrupted quality compressions. Promotion of Hands-Only CPR should improve the incidence of bystander CPR and, subsequently, survival from OOH cardiac arrest; but, little is known about a rescuer's ability to deliver continuous chest compressions of adequate rate and depth for periods typical of emergency services response time. This study evaluated chest compression rate and depth as subjects performed Hands-Only CPR for 10 minutes. For comparison purposes, each also performed chest compressions with ventilations (30:2 CPR. It also evaluated fatigue and changes in body biomechanics associated with each type of CPR. Methods Twenty healthy female volunteers certified in basic life support performed Hands-Only CPR and 30:2 CPR on a manikin. A mixed model repeated measures cross-over design evaluated chest compression rate and depth, changes in fatigue (chest compression force, perceived exertion, and blood lactate level, and changes in electromyography and joint kinetics and kinematics. Results All subjects completed 10 minutes of 30:2 CPR; but, only 17 completed 10 minutes of Hands-Only CPR. Rate, average depth, percentage at least 38 millimeters deep, and force of compressions were significantly lower in Hands-Only CPR than in 30:2 CPR. Rates were maintained; but, compression depth and force declined significantly from beginning to end CPR with most decrement occurring in the first two minutes. Perceived effort and joint torque changes were significantly greater in Hands-Only CPR. Performance was not influenced by age. Conclusion Hands-Only CPR required greater effort and was harder to sustain than 30:2 CPR. It is not known whether the observed greater decrement in chest compression depth associated

  5. Beneficial effects of a Paleolithic diet on cardiovascular risk factors in type 2 diabetes: a randomized cross-over pilot study

    Directory of Open Access Journals (Sweden)

    Hansson Anita

    2009-07-01

    Full Text Available Abstract Background Our aim was to compare the effects of a Paleolithic ('Old Stone Age' diet and a diabetes diet as generally recommended on risk factors for cardiovascular disease in patients with type 2 diabetes not treated with insulin. Methods In a randomized cross-over study, 13 patients with type 2 diabetes, 3 women and 10 men, were instructed to eat a Paleolithic diet based on lean meat, fish, fruits, vegetables, root vegetables, eggs and nuts; and a Diabetes diet designed in accordance with dietary guidelines during two consecutive 3-month periods. Outcome variables included changes in weight, waist circumference, serum lipids, C-reactive protein, blood pressure, glycated haemoglobin (HbA1c, and areas under the curve for plasma glucose and plasma insulin in the 75 g oral glucose tolerance test. Dietary intake was evaluated by use of 4-day weighed food records. Results Study participants had on average a diabetes duration of 9 years, a mean HbA1c of 6,6% units by Mono-S standard and were usually treated with metformin alone (3 subjects or metformin in combination with a sulfonylurea (3 subjects or a thiazolidinedione (3 subjects. Mean average dose of metformin was 1031 mg per day. Compared to the diabetes diet, the Paleolithic diet resulted in lower mean values of HbA1c (-0.4% units, p = 0.01, triacylglycerol (-0.4 mmol/L, p = 0.003, diastolic blood pressure (-4 mmHg, p = 0.03, weight (-3 kg, p = 0.01, BMI (-1 kg/m2, p = 0.04 and waist circumference (-4 cm, p = 0.02, and higher mean values of high density lipoprotein cholesterol (+0.08 mmol/L, p = 0.03. The Paleolithic diet was mainly lower in cereals and dairy products, and higher in fruits, vegetables, meat and eggs, as compared with the Diabetes diet. Further, the Paleolithic diet was lower in total energy, energy density, carbohydrate, dietary glycemic load, saturated fatty acids and calcium, and higher in unsaturated fatty acids, dietary cholesterol and several vitamins. Dietary GI

  6. Beneficial effects of a Paleolithic diet on cardiovascular risk factors in type 2 diabetes: a randomized cross-over pilot study.

    Science.gov (United States)

    Jönsson, Tommy; Granfeldt, Yvonne; Ahrén, Bo; Branell, Ulla-Carin; Pålsson, Gunvor; Hansson, Anita; Söderström, Margareta; Lindeberg, Staffan

    2009-07-16

    Our aim was to compare the effects of a Paleolithic ('Old Stone Age') diet and a diabetes diet as generally recommended on risk factors for cardiovascular disease in patients with type 2 diabetes not treated with insulin. In a randomized cross-over study, 13 patients with type 2 diabetes, 3 women and 10 men, were instructed to eat a Paleolithic diet based on lean meat, fish, fruits, vegetables, root vegetables, eggs and nuts; and a Diabetes diet designed in accordance with dietary guidelines during two consecutive 3-month periods. Outcome variables included changes in weight, waist circumference, serum lipids, C-reactive protein, blood pressure, glycated haemoglobin (HbA1c), and areas under the curve for plasma glucose and plasma insulin in the 75 g oral glucose tolerance test. Dietary intake was evaluated by use of 4-day weighed food records. Study participants had on average a diabetes duration of 9 years, a mean HbA1c of 6,6% units by Mono-S standard and were usually treated with metformin alone (3 subjects) or metformin in combination with a sulfonylurea (3 subjects) or a thiazolidinedione (3 subjects). Mean average dose of metformin was 1031 mg per day. Compared to the diabetes diet, the Paleolithic diet resulted in lower mean values of HbA1c (-0.4% units, p = 0.01), triacylglycerol (-0.4 mmol/L, p = 0.003), diastolic blood pressure (-4 mmHg, p = 0.03), weight (-3 kg, p = 0.01), BMI (-1 kg/m2, p = 0.04) and waist circumference (-4 cm, p = 0.02), and higher mean values of high density lipoprotein cholesterol (+0.08 mmol/L, p = 0.03). The Paleolithic diet was mainly lower in cereals and dairy products, and higher in fruits, vegetables, meat and eggs, as compared with the Diabetes diet. Further, the Paleolithic diet was lower in total energy, energy density, carbohydrate, dietary glycemic load, saturated fatty acids and calcium, and higher in unsaturated fatty acids, dietary cholesterol and several vitamins. Dietary GI was slightly lower in the Paleolithic diet

  7. Effect of acute hyperglycemia on left ventricular contractile function in diabetic patients with and without heart failure: two randomized cross-over studies.

    Directory of Open Access Journals (Sweden)

    Roni Nielsen

    Full Text Available It is unknown whether changes in circulating glucose levels due to short-term insulin discontinuation affect left ventricular contractile function in type 2 diabetic patients with (T2D-HF and without (T2D-nonHF heart failure.In two randomized cross-over-designed trials, 18 insulin-treated type 2 diabetic patients with (Ejection Fraction (EF 36 ± 6%, n = 10 (trial 2 and without systolic heart failure (EF 60 ± 3%, n = 8 (trial 1 were subjected to hyper- and normoglycemia for 9-12 hours on two different occasions. Advanced echocardiography, bicycle exercise tests and 6-minute hall walk distance were applied.Plasma glucose levels differed between study arms (6.5 ± 0.8 mM vs 14.1 ± 2.6 mM (T2D-HF, 5.8 ± 0.4 mM vs 9.9 ± 2.1 mM (T2D-nonHF, p<0.001. Hyperglycemia was associated with an increase in several parameters: maximal global systolic tissue velocity (Vmax (p<0.001, maximal mitral annulus velocity (S'max (p<0.001, strain rate (p = 0.02 and strain (p = 0.05. Indices of increased myocardial systolic contractile function were significant in both T2D-HF (Vmax: 14%, p = 0.02; S'max: 10%, p = 0.04, T2D-nonHF (Vmax: 12%, p<0.01; S'max: 9%, p<0.001 and in post exercise S'max (7%, p = 0.049 during hyperglycemia as opposed to normoglycemia. LVEF did not differ between normo- and hyperglycemia (p = 0.17, and neither did peak exercise capacity nor catecholamine levels. Type 2 diabetic heart failure patients' 6-minute hall walk distance improved by 7% (p = 0.02 during hyperglycemia as compared with normoglycemia.Short-term hyperglycemia by insulin discontinuation is associated with an increase in myocardial systolic contractile function in type 2 diabetic patients with and without heart failure and with a slightly prolonged walking distance in type 2 diabetic heart failure patients. (Clinicaltrials.gov identifier NCT00653510.

  8. Heat training increases exercise capacity in hot but not in temperate conditions: a mechanistic counter-balanced cross-over study.

    Science.gov (United States)

    Keiser, Stefanie; Flück, Daniela; Hüppin, Fabienne; Stravs, Alexander; Hilty, Matthias P; Lundby, Carsten

    2015-09-01

    The aim was to determine the mechanisms facilitating exercise performance in hot conditions following heat training. In a counter-balanced order, seven males (V̇o2max 61.2 ± 4.4 ml·min(-1)·kg(-1)) were assigned to either 10 days of 90-min exercise training in 18 or 38°C ambient temperature (30% relative humidity) applying a cross-over design. Participants were tested for V̇o2max and 30-min time trial performance in 18 (T18) and 38°C (T38) before and after training. Blood volume parameters, sweat output, cardiac output (Q̇), cerebral perfusion (i.e., middle cerebral artery velocity [MCAvmean]), and other variables were determined. Before one set of exercise tests in T38, blood volume was acutely expanded by 538 ± 16 ml with an albumin solution (T38A) to determine the role of acclimatization induced hypervolemia on exercise performance. We furthermore hypothesized that heat training would restore MCAvmean and thereby limit centrally mediated fatigue. V̇o2max and time trial performance were equally reduced in T38 and T38A (7.2 ± 1.6 and 9.3 ± 2.5% for V̇o2max; 12.8 ± 2.8 and 12.9 ± 2.8% for time trial). Following heat training both were increased in T38 (9.6 ± 2.1 and 10.4 ± 3.1%, respectively), whereas both V̇o2max and time trial performance remained unchanged in T18. As expected, heat training augmented plasma volume (6 ± 2%) and mean sweat output (26 ± 6%), whereas sweat [Na(+)] became reduced by 19 ± 7%. In T38 Q̇max remained unchanged before (21.3 ± 0.6 l/min) to after (21.7 ± 0.5 l/min) training, whereas MCAvmean was increased by 13 ± 10%. However, none of the observed adaptations correlated with the concomitant observed changes in exercise performance. Copyright © 2015 the American Physiological Society.

  9. A randomized cross-over study of the quality of cardiopulmonary resuscitation among females performing 30:2 and hands-only cardiopulmonary resuscitation.

    Science.gov (United States)

    Trowbridge, Cynthia; Parekh, Jesal N; Ricard, Mark D; Potts, Jerald; Patrickson, W Clive; Cason, Carolyn L

    2009-07-07

    Hands-Only cardiopulmonary resuscitation (CPR) is recommended for use on adult victims of witnessed out-of-hospital (OOH) sudden cardiac arrest or in instances where rescuers cannot perform ventilations while maintaining minimally interrupted quality compressions. Promotion of Hands-Only CPR should improve the incidence of bystander CPR and, subsequently, survival from OOH cardiac arrest; but, little is known about a rescuer's ability to deliver continuous chest compressions of adequate rate and depth for periods typical of emergency services response time. This study evaluated chest compression rate and depth as subjects performed Hands-Only CPR for 10 minutes. For comparison purposes, each also performed chest compressions with ventilations (30:2) CPR. It also evaluated fatigue and changes in body biomechanics associated with each type of CPR. Twenty healthy female volunteers certified in basic life support performed Hands-Only CPR and 30:2 CPR on a manikin. A mixed model repeated measures cross-over design evaluated chest compression rate and depth, changes in fatigue (chest compression force, perceived exertion, and blood lactate level), and changes in electromyography and joint kinetics and kinematics. All subjects completed 10 minutes of 30:2 CPR; but, only 17 completed 10 minutes of Hands-Only CPR. Rate, average depth, percentage at least 38 millimeters deep, and force of compressions were significantly lower in Hands-Only CPR than in 30:2 CPR. Rates were maintained; but, compression depth and force declined significantly from beginning to end CPR with most decrement occurring in the first two minutes. Perceived effort and joint torque changes were significantly greater in Hands-Only CPR. Performance was not influenced by age. Hands-Only CPR required greater effort and was harder to sustain than 30:2 CPR. It is not known whether the observed greater decrement in chest compression depth associated with Hands-Only CPR would offset the potential physiological

  10. Adenosine 5′-triphosphate (ATP supplements are not orally bioavailable: a randomized, placebo-controlled cross-over trial in healthy humans

    Directory of Open Access Journals (Sweden)

    Arts Ilja CW

    2012-04-01

    Full Text Available Abstract Background Nutritional supplements designed to increase adenosine 5′-triphosphate (ATP concentrations are commonly used by athletes as ergogenic aids. ATP is the primary source of energy for the cells, and supplementation may enhance the ability to maintain high ATP turnover during high-intensity exercise. Oral ATP supplements have beneficial effects in some but not all studies examining physical performance. One of the remaining questions is whether orally administered ATP is bioavailable. We investigated whether acute supplementation with oral ATP administered as enteric-coated pellets led to increased concentrations of ATP or its metabolites in the circulation. Methods Eight healthy volunteers participated in a cross-over study. Participants were given in random order single doses of 5000 mg ATP or placebo. To prevent degradation of ATP in the acidic environment of the stomach, the supplement was administered via two types of pH-sensitive, enteric-coated pellets (targeted at release in the proximal or distal small intestine, or via a naso-duodenal tube. Blood ATP and metabolite concentrations were monitored by HPLC for 4.5 h (naso-duodenal tube or 7 h (pellets post-administration. Areas under the concentration vs. time curve were calculated and compared by paired-samples t-tests. Results ATP concentrations in blood did not increase after ATP supplementation via enteric-coated pellets or naso-duodenal tube. In contrast, concentrations of the final catabolic product of ATP, uric acid, were significantly increased compared to placebo by ~50% after administration via proximal-release pellets (P = 0.003 and naso-duodenal tube (P = 0.001, but not after administration via distal-release pellets. Conclusions A single dose of orally administered ATP is not bioavailable, and this may explain why several studies did not find ergogenic effects of oral ATP supplementation. On the other hand, increases in uric acid after release of

  11. Palaeolithic diet decreases fasting plasma leptin concentrations more than a diabetes diet in patients with type 2 diabetes: a randomised cross-over trial.

    Science.gov (United States)

    Fontes-Villalba, Maelán; Lindeberg, Staffan; Granfeldt, Yvonne; Knop, Filip K; Memon, Ashfaque A; Carrera-Bastos, Pedro; Picazo, Óscar; Chanrai, Madhvi; Sunquist, Jan; Sundquist, Kristina; Jönsson, Tommy

    2016-05-23

    We have previously shown that a Palaeolithic diet consisting of the typical food groups that our ancestors ate during the Palaeolithic era, improves cardiovascular disease risk factors and glucose control compared to the currently recommended diabetes diet in patients with type 2 diabetes. To elucidate the mechanisms behind these effects, we evaluated fasting plasma concentrations of glucagon, insulin, incretins, ghrelin, C-peptide and adipokines from the same study. In a randomised, open-label, cross-over study, 13 patients with type 2 diabetes were randomly assigned to eat a Palaeolithic diet based on lean meat, fish, fruits, vegetables, root vegetables, eggs and nuts, or a diabetes diet designed in accordance with current diabetes dietary guidelines during two consecutive 3-month periods. The patients were recruited from primary health-care units and included three women and 10 men [age (mean ± SD) 64 ± 6 years; BMI 30 ± 7 kg/m(2); diabetes duration 8 ± 5 years; glycated haemoglobin 6.6 ± 0.6 % (57.3 ± 6 mmol/mol)] with unaltered diabetes treatment and stable body weight for 3 months prior to the start of the study. Outcome variables included fasting plasma concentrations of leptin, adiponectin, adipsin, visfatin, resistin, glucagon, insulin, C-peptide, glucose-dependent insulinotropic polypeptide, glucagon-like peptide-1 and ghrelin. Dietary intake was evaluated by use of 4-day weighed food records. Seven participants started with the Palaeolithic diet and six with the diabetes diet. The Palaeolithic diet resulted in a large effect size (Cohen's d = -1.26) at lowering fasting plasma leptin levels compared to the diabetes diet [mean difference (95 % CI), -2.3 (-5.1 to 0.4) ng/ml, p = 0.023]. No statistically significant differences between the diets for the other variables, analysed in this study, were observed. Over a 3-month study period, a Palaeolithic diet resulted in reduced fasting plasma leptin levels, but did not change fasting levels of insulin, C

  12. Vision - night blindness

    Science.gov (United States)

    ... this page: //medlineplus.gov/ency/article/003039.htm Vision - night blindness To use the sharing features on ... page, please enable JavaScript. Night blindness is poor vision at night or in dim light. Considerations Night ...

  13. Leading Causes of Blindness

    Science.gov (United States)

    ... Home Current Issue Past Issues Feature: Vision Leading Causes of Blindness Past Issues / Summer 2008 Table of ... million Americans have cataracts. They are the leading cause of blindness in the world. By age 80, ...

  14. A randomised cross-over comparison of the transverse and longitudinal techniques for ultrasound-guided identification of the cricothyroid membrane in morbidly obese subjects

    DEFF Research Database (Denmark)

    Kristensen, M S; Teoh, W H; Rudolph, S S

    2016-01-01

    -on training, and then applied both techniques in a randomised, cross-over sequence to obese females with body mass index 39.0 - 43.9 kg.m(-2) . The mean (SD) time to identify the cricothyroid membrane was 24.0 (12.4) s using the transverse technique compared with 37.6 (17.9) s for the longitudinal technique...

  15. Plasma exchange combined with azathioprine in multiple sclerosis using serial gadolinium-enhanced MRI to monitor disease activity: a randomized single-masked cross-over pilot study

    DEFF Research Database (Denmark)

    Sørensen, P.S.; Wanscher, B; Szpirt, W

    1996-01-01

    We enrolled 11 patients with secondary progressive MS in a randomized single-masked cross-over study of plasma exchange (PE) in combination with azathioprine 2 mg/kg. PE was performed once a week for 4 weeks and thereafter every second week for 20 weeks (14 treatments). Eight patients completed...... in the two periods. Although the total MS lesion load on MRI was significantly lower (p effect of PE or encourage a subsequent large...

  16. Restrictive partially blind signature for resource-constrained information systems

    NARCIS (Netherlands)

    Qiu, Weidong; Gong, Zheng; Liu, Bozhong; Long, Yu; Chen, Kefei

    2010-01-01

    Restrictive partially blind signature, which is designed for privacy oriented information systems, allows a user to obtain a blind signature from a signer whilst the blind message must obey some certain rules. In order to reduce storage and communication costs, several public-key cryptosystems are

  17. Low-dose oral contraceptives and acquired resistance to activated protein C: a randomised cross-over study

    NARCIS (Netherlands)

    Rosing, J.; Middeldorp, S.; Curvers, J.; Christella, M.; Thomassen, L. G.; Nicolaes, G. A.; Meijers, J. C.; Bouma, B. N.; Büller, H. R.; Prins, M. H.; Tans, G.

    1999-01-01

    BACKGROUND: We have reported previously that, compared with use of second-generation oral contraceptives, the use of third-generation oral contraceptives is associated with increased resistance to the anticoagulant action of activated protein C (APC). Owing to the cross-sectional design of that

  18. Salivary Secretory Immunoglobulin a secretion increases after 4-weeks ingestion of chlorella-derived multicomponent supplement in humans: a randomized cross over study

    Science.gov (United States)

    2011-01-01

    Background Chlorella, a unicellular green alga that grows in fresh water, contains high levels of proteins, vitamins, minerals, and dietary fibers. Some studies have reported favorable immune function-related effects on biological secretions such as blood and breast milk in humans who have ingested a chlorella-derived multicomponent supplement. However, the effects of chlorella-derived supplement on mucosal immune functions remain unclear. The purpose of this study was to investigate whether chlorella ingestion increases the salivary secretory immunoglobulin A (SIgA) secretion in humans using a blind, randomized, crossover study design. Methods Fifteen men took 30 placebo and 30 chlorella tablets per day for 4 weeks separated by a 12-week washout period. Before and after each trial, saliva samples were collected from a sterile cotton ball that was chewed after overnight fasting. Salivary SIgA concentrations were measured using ELISA. Results Compliance rates for placebo and chlorella ingestions were 97.0 ± 1.0% and 95.3 ± 1.6%, respectively. No difference was observed in salivary SIgA concentrations before and after placebo ingestion (P = 0.38). However, salivary SIgA concentrations were significantly elevated after chlorella ingestion compared to baseline (P chlorella ingestion than before intake (P chlorella-derived multicomponent supplement increases salivary SIgA secretion and possibly improves mucosal immune function in humans. PMID:21906314

  19. Comparison of contract appearance of gadobenate-dimeglumine and GA-DTPA in intra-axial brain tumors; Vergleich des Kontrastverhaltens von Gadobenat-Dimeglumine und Gd-DTPA bei intraaxialen Hirntumoren. Eine doppelblinde randomisierte intraindividuelle Cross-over-Studie

    Energy Technology Data Exchange (ETDEWEB)

    Essig, M.; Knopp, M.V. [Deutsches Krebsforschungszentrum Heidelberg (Germany). Abt. Radiologische Diagnostik und Therapie; Hartmann, M.; Jansen, O. [Abt. Klinische Neuroradiologie, Univ. Heidelberg (Germany); Lodemann, K.P.; Seeberg, A. [Bracco-Byk-Gulden, Konstanz (Germany); Runge, V.M. [Univ. of Kentucky, Lexington (United States)

    2001-12-01

    The purposes of the study was to assess intraaxial brain tumors by a blinded comparison of gadobenat-dimeglumine and Gd-DTPA 27 patients with known cerebral gliomas or metastases were included into an intra-individual randomized double-blinded cross-over study. The protocol included T1 SE, T2 FSE and after contrast a series of five T1 SE sequences followed by T1 SE with MT, T1 SE, and 3D GRE sequences. Imaging data acquired at two centers were assessed on-site by the investigators and off-site by two experienced readers using quantitative and qualitative criteria. For a quantitative analysis tumor contrast and contrast-to-noise ratios were determined out of ROI in tumor, unaffected white matter, a region outside the head, and an external reference tube. For the qualitative assessment on- and off-site readers were asked to compare both MR scans for lesion contrast, lesion delineation and information upon the internal morphology and structure. In the quantitative analysis lesions examined with gadobenat-dimeglumine present a maximal 26% increase of the lesion contrast. In both, the on-site, as well as the off-site assessment the intensity of enhancement and the lesion contrast were found to be significantly better with gadobenat-dimeglumine enhanced MRI. There was a trend towards gadobenat-dimeglumine for the delineation of the lesion from the surrounding tissue and the internal lesion morphology. Based on our observations gadobenat-dimeglumine proved to be a safe and valuable contrast media for the assessment of CNS neoplasms. Compared with Gd-DTPA it provides a more intense contrast enhancement and a better tumor contrast which might be of importance for the further management of these patients. (orig.) [German] In einer doppelt verblindeten randomisierten intraindividuel en Cross-Over Vergleichsuntersuchung wurden 27 Patienten mit intraaxialen Hirntumoren mittels der MR-Kontrastmittel Gadobenat-Dimeglumine (Multihance trademark) und Gd-DTPA (Magnevist{sup circled

  20. A double-blind clinical trial of griseofulvin in patients with Raynaud's phenomenon

    Science.gov (United States)

    Sabri, S.; Roberts, V. C.; Higgins, R. F.; Cotton, L. T.; Williams, D. I.; Wilson, L. C.

    1973-01-01

    Twenty-four patients with Raynaud's phenomenon were treated with griseofulvin and a placebo in a double-blind cross-over clinical trial. The results were assessed subjectively and plotted sequentially. The number of patients able to distinguish the active from the placebo treatment was statistically significant (P=0·05). There were indications that the response was dose dependent. Further studies are needed to establish whether griseofulvin offers useful clinical improvement in this condition. PMID:4596620

  1. Meals based on vegetable protein sources (beans and peas) are more satiating than meals based on animal protein sources (veal and pork) - a randomized cross-over meal test study.

    Science.gov (United States)

    Kristensen, Marlene D; Bendsen, Nathalie T; Christensen, Sheena M; Astrup, Arne; Raben, Anne

    2016-01-01

    Recent nutrition recommendations advocate a reduction in protein from animal sources (pork, beef) because of environmental concerns. Instead, protein from vegetable sources (beans, peas) should be increased. However, little is known about the effect of these vegetable protein sources on appetite regulation. To examine whether meals based on vegetable protein sources (beans/peas) are comparable to meals based on animal protein sources (veal/pork) regarding meal-induced appetite sensations. In total, 43 healthy, normal-weight, young men completed this randomized, double-blind, placebo-controlled, three-way, cross-over meal test. The meals (all 3.5 MJ, 28 energy-% (E%) fat) were either high protein based on veal and pork meat, HP-Meat (19 E% protein, 53 E% carbohydrate, 6 g fiber/100 g); high protein based on legumes (beans and peas), HP-Legume (19 E% protein, 53 E% carbohydrate, 25 g fiber/100 g); or low-protein based on legumes, LP-Legume (9 E% protein, 62 E% carbohydrate, 10 g fiber/100 g). Subjective appetite sensations were recorded at baseline and every half hour using visual analog scales until the ad libitum meal 3 h after the test meal. Repeated measurements analyses and summary analyses were performed using ANCOVA (SAS). HP-Legume induced lower composite appetite score, hunger, prospective food consumption, and higher fullness compared to HP-Meat and LP-Legume ( p Vegetable-based meals (beans/peas) influenced appetite sensations favorably compared to animal-based meals (pork/veal) with similar energy and protein content, but lower fiber content. Interestingly, a vegetable-based meal with low protein content was as satiating and palatable as an animal-based meal with high protein content.

  2. A single dose, randomized, open-label, cross-over bioequivalence study of sildenafil citrate tablets in healthy Chinese volunteers
.

    Science.gov (United States)

    Li, Dai; Wang, Yu-Lu; Xu, Su-Mei; Li, Dan; Li, Xiao-Min; Pan, Jing; Xu, Ping-Sheng

    2017-02-01

    The present study was designed to evaluate the bioequivalence of a newly developed sildenafil citrate tablet 50 mg (Jinge®, Test) and a marketed counterpart (Viagra®, 100 mg, Reference) in healthy adult male Chinese volunteers. This single-dose, randomized, open-label, four-period, and two-treatment self-crossover study included two parts: fasting and postprandial studies. In each part of the study, the subjects were randomly assigned to receive test or reference products (100 mg sildenafil) in a 1 : 1 ratio, and then received the alternative products, following a 1-week washout period. Plasma sildenafil concentrations were analyzed by liquid chromatography-tandem mass spectrometry. Tolerability was assessed during the entire study period. 32 healthy volunteers (aged 19 - 30) were enrolled in the study; 31 volunteers completed the fasting study, while 32 volunteers completed the postprandial study. The test formulation was bioequivalent to the marketed formulation as the 90% CIs for the ratio of geometric means of Cmax (fasting: 98.79 - 119.61%; fed: 94.47 - 119.65%), AUClast (fasting: 98.70 - 109.71%; fed: 96.39 - 112.89%), and AUC∞ (fasting: 98.45 - 108.87%; fed: 96.36 - 112.74%) were within equivalence limits (80 - 125%) under both fasting and postprandial conditions. When sildenafil was given with high-fat meals, mean Cmax was reduced by 23%, and median tmax ranged from 0.75 to 1.50 hours (p ≤ 0.05). However, both AUClast and AUC∞ were comparable between fasting and postprandial conditions. No serious adverse events were found among the subjects. This study confirmed that test and reference sildenafil citrate tablets were bioequivalent under fasting and postprandial conditions.
.

  3. Bridging the gap in 1(st) year dental material curriculum: A 3 year randomized cross over trial.

    Science.gov (United States)

    Gali, Sivaranjani; Shetty, Vibha; Murthy, N S; Marimuthu, P

    2015-01-01

    Case-oriented small group discussions (COSGDs) can help students to correlate and integrate the basic science of dental materials into clinical application. We used COSGDs along with didactic lectures in dental material curriculum and hypothesized that case-oriented group discussions would be more effective than traditional lecture alone in terms of performance of students, student perception on the above two teaching methodologies and the feasibility in classes of 2010, 2011 and 2012. A total of 170 students were taught using both COSGD and didactic lecture in a randomized controlled crossover trial design. Their performance was assessed through multiple-choice questions (MCQs) as part of the formative assessment, and their perception was assessed through Likert scale questionnaire. The mean difference in the scores between case-oriented group discussions with lecture and didactic lecture showed significant difference only in few topics. Around 94-96% of students perceived COSGD with didactic lecture help them understand theory better; 76-92% of students feel more comfortable asking questions in a group discussion; 89-98% of students feel such discussions motivate them and 91-100% of students agree that discussions make the subject interesting in the respective years of 2010, 2011 and 2012. Effectiveness of COSGD in terms of scores through MCQs is comparable to traditional lecture. However, most of the students perceive COSGD help them understand the theory better; co-relate clinically; more motivating and interesting than a traditional lecture. Feasibility in institution needs more time and resources to conduct COSGD within the dental material curriculum.

  4. Postictal blindness in adults.

    OpenAIRE

    Sadeh, M; Goldhammer, Y; Kuritsky, A

    1983-01-01

    Cortical blindness following grand mal seizures occurred in five adult patients. The causes of seizures included idiopathic epilepsy, vascular accident, brain cyst, acute encephalitis and chronic encephalitis. Blindness was permanent in one patients, but the others recovered within several days. Since most of the patients were either unaware of or denied their blindness, it is possible that this event often goes unrecognised. Cerebral hypoxia is considered the most likely mechanism.

  5. Causes of blindness and visual impairment at the school for the ...

    African Journals Online (AJOL)

    Aim : This study was designed to determine the causes of blindness amongst the pupils of the School for the blind ,Owo and also identify treatable causes of blindness in the study population. Methodology : This study was conducted between November and December,2007 at the School for the blind, Owo. Ethical clearance ...

  6. A note on parallel executions of restrictive blind issuing protocols for secret-key certificates

    NARCIS (Netherlands)

    S.A. Brands (Stefan)

    1995-01-01

    textabstractThe receiver in a restrictive blind certificate issuing protocol can blind the issued public key and the certificate but not a certain blinding-invariant predicate of the secret key. Recently a generally applicable technique was described for designing restrictive blind issuing protocols

  7. The effect of using an audience response system on learning, motivation and information retention in the orthodontic teaching of undergraduate dental students: a cross-over trial.

    Science.gov (United States)

    Dhaliwal, Harmeet Kaur; Allen, Mark; Kang, Jing; Bates, Claire; Hodge, Trevor

    2015-06-01

    New methods of teaching and learning are constantly being sought in the adult learning environment. Audience Response Systems (ARS) have been used in many different learning environments, especially in the field of medical education. The objective of this investigation was to ascertain the effect of ARS use in undergraduate teaching in a UK dental school. A cross-over clustered randomized educational trial. Leeds Dental Institute. Year 4 undergraduate dental students in orthodontics. Students at Leeds Dental Institute were taught two different topics within the curriculum to test the use of ARS in a cross-over trial. A questionnaire was delivered to the test (ARS) and control (non-ARS) groups. The response rate to the questionnaires was 89·5% (test group) and 82·9% (control group). The ARS enabled students to perform better as shown by knowledge retention (P = 0·013). Students found the seminar more interesting (P = 0·013), easier to concentrate (P = 0·025) and easier to participate in (P = 0·020) when ARS was used. When ARS was used, students were more able to answer questions (Pteaching and significantly improved knowledge retention. ARS may be useful in facilitating orthodontic teaching in the future.

  8. Impact of olive oil-rich diet on serum omentin and adiponectin levels: a randomized cross-over clinical trial among overweight women.

    Science.gov (United States)

    Kabiri, Akram; Hosseinzadeh-Attar, Mohammad Javad; Haghighatdoost, Fahimeh; Eshraghian, Mohammadreza; Esmaillzadeh, Ahmad

    2017-08-01

    This study aimed to investigate the effect of olive oil-rich diet on omentin and adiponectin concentrations. This cross-over randomized trial included 17 overweight women. Participants were assigned to consume either a usual (16% saturated fatty acids [SFA] and 8% monounsaturated fatty acid [MUFA]) or an olive oil-rich diet (16% MUFA and 8% SFA) for 6 weeks crossing over after a 2-week washout period. There was no significant difference in the changes of omentin between two dietary interventions. However, in the adjusted model for polyunsaturated fatty acids and fat mass, usual diet tended to decrease omentin levels whilst olive oil-rich diet tended to increase (-56.1 ± 32.0 versus 40.6 ± 32.0 ng/mL; p = .056). Adiponectin levels increased during two periods, but changes were greater during olive oil-rich diet with a trend toward significance (4.8 ± 3.0 versus 13.4 ± 3.0 μg/mL; p = .06). Consumption of olive oil-rich diet tended to increase omentin and adiponectin in comparison with the usual diet.

  9. Impact of palm date consumption on microbiota growth and large intestinal health: a randomised, controlled, cross-over, human intervention study.

    Science.gov (United States)

    Eid, Noura; Osmanova, Hristina; Natchez, Cecile; Walton, Gemma; Costabile, Adele; Gibson, Glenn; Rowland, Ian; Spencer, Jeremy P E

    2015-10-28

    The reported inverse association between the intake of plant-based foods and a reduction in the prevalence of colorectal cancer may be partly mediated by interactions between insoluble fibre and (poly)phenols and the intestinal microbiota. In the present study, we assessed the impact of palm date consumption, rich in both polyphenols and fibre, on the growth of colonic microbiota and markers of colon cancer risk in a randomised, controlled, cross-over human intervention study. A total of twenty-two healthy human volunteers were randomly assigned to either a control group (maltodextrin-dextrose, 37·1 g) or an intervention group (seven dates, approximately 50 g). Each arm was of 21 d duration and was separated by a 14-d washout period in a cross-over manner. Changes in the growth of microbiota were assessed by fluorescence in situ hybridisation analysis, whereas SCFA levels were assessed using HPLC. Further, ammonia concentrations, faecal water genotoxicity and anti-proliferation ability were also assessed using different assays, which included cell work and the Comet assay. Accordingly, dietary intakes, anthropometric measurements and bowel movement assessment were also carried out. Although the consumption of dates did not induce significant changes in the growth of select bacterial groups or SCFA, there were significant increases in bowel movements and stool frequency (Pconsumption of dates, relative to baseline. Furthermore, date fruit intake significantly reduced genotoxicity in human faecal water relative to control (Pconsumption of date fruit may reduce colon cancer risk without inducing changes in the microbiota.

  10. Design paper: The CapOpus trial: a randomized, parallel-group, observer-blinded clinical trial of specialized addiction treatment versus treatment as usual for young patients with cannabis abuse and psychosis

    DEFF Research Database (Denmark)

    Hjorthøj, Carsten; Fohlmann, Allan; Larsen, Anne-Mette

    2008-01-01

    : The major objective for the CapOpus trial is to evaluate the additional effect on cannabis abuse of a specialized addiction treatment program adding group treatment and motivational interviewing to treatment as usual. DESIGN: The trial is designed as a randomized, parallel-group, observer-blinded clinical...... trial. Patients are primarily recruited through early-psychosis detection teams, community mental health centers, and assertive community treatment teams. Patients are randomized to one of two treatment arms, both lasting six months: 1) specialized addiction treatment plus treatment as usual or 2......) treatment as usual. The specialized addiction treatment is manualized and consists of both individual and group-based motivational interviewing and cognitive behavioral therapy, and incorporates both the family and the case manager of the patient.The primary outcome measure will be changes in amount...

  11. Design paper: The CapOpus trial: a randomized, parallel-group, observer-blinded clinical trial of specialized addiction treatment versus treatment as usual for young patients with cannabis abuse and psychosis

    DEFF Research Database (Denmark)

    Hjorthøj, Carsten; Fohlmann, Allan; Larsen, Anne-Mette

    2008-01-01

    BACKGROUND: A number of studies indicate a link between cannabis-use and psychosis as well as more severe psychosis in those with existing psychotic disorders. There is currently insufficient evidence to decide the optimal way to treat cannabis abuse among patients with psychosis. OBJECTIVES......: The major objective for the CapOpus trial is to evaluate the additional effect on cannabis abuse of a specialized addiction treatment program adding group treatment and motivational interviewing to treatment as usual. DESIGN: The trial is designed as a randomized, parallel-group, observer-blinded clinical...... of cannabis consumption over time. Other outcome measures will be psychosis symptoms, cognitive functioning, quality of life, social functioning, and cost-benefit analyses. TRIAL REGISTRATION: ClinicalTrials.gov NCT00484302....

  12. Individual differences in response to randomly assigned active individualized homeopathic and placebo treatment in fibromyalgia: implications of a double-blinded optional crossover design.

    Science.gov (United States)

    Bell, Iris R; Lewis, Daniel A; Brooks, Audrey J; Schwartz, Gary E; Lewis, Sabrina E; Caspi, Opher; Cunningham, Victoria; Baldwin, Carol M

    2004-04-01

    To assess individual difference characteristics of subgroups of patients with fibromyalgia (FM) patients with respect to the decision to stay in or switch from randomly-assigned verum or placebo treatment during an optional crossover phase of a double-blinded homeopathy study. Double-blinded, randomized, placebo-controlled, optional crossover clinical trial. Fifty-three (53) community-recruited patients with FM entered the optional crossover phase. Two homeopaths jointly selected an individualized homeopathic remedy for all patients. The pharmacy dispensed either verum LM remedy or indistinguishable placebo in accord with randomized assignment for 4 months and the patient's optional crossover decision for an additional 2 months. Patients completed a battery of baseline state/trait questionnaires, including mood, childhood neglect and abuse, and trait absorption. They rated global health (whole person-centered) and tender point pain on physical examination (disease-specific) at baseline, 3 months, and 6 months. Rates of optional crossover from verum to placebo or placebo to verum were comparable (p = 0.6; 31%, and 41%, respectively). The switch subgroups had greater baseline psychologic issues (emotional neglect in placebo-switch; depression and anger in verum-switch). The verum-stay subgroup scored highest on treatment helpfulness and included all six exceptional responders who fell, prior to crossover, into the top terciles for improvement in both global health and pain. Patients staying in their randomly assigned groups, active or placebo (n = 34), scored significantly higher in trait absorption than did those who switched groups (n = 19). Individual difference factors may predict better and poorer responders with FM to specific and nonspecific effects of homeopathic and placebo treatment.

  13. Static analysis for blinding

    DEFF Research Database (Denmark)

    Nielsen, Christoffer Rosenkilde; Nielson, Hanne Riis

    2006-01-01

    operation blinding. In this paper we study the theoretical foundations for one of the successful approaches to validating cryptographic protocols and we extend it to handle the blinding primitive. Our static analysis approach is based on Flow Logic; this gives us a clean separation between the specification...

  14. Blinded by Irrelevance: Pure Irrelevance Induced "Blindness"

    Science.gov (United States)

    Eitam, Baruch; Yeshurun, Yaffa; Hassan, Kinneret

    2013-01-01

    To what degree does our representation of the immediate world depend solely on its relevance to what we are currently doing? We examined whether relevance per se can cause "blindness," even when there is no resource limitation. In a novel paradigm, people looked at a colored circle surrounded by a differently colored ring--the task relevance of…

  15. Tramadol relieves pain and allodynia in polyneuropathy: a randomised, double-blind, controlled trial.

    Science.gov (United States)

    Sindrup, S H; Andersen, G; Madsen, C; Smith, T; Brøsen, K; Jensen, T S

    1999-10-01

    It is generally believed that opioids relieve neuropathic pain less effectively than nociceptive pain and that they have no effect on some of the key characteristics of neuropathic pain such as touch-evoked pain (allodynia). Tramadol is an analgesic drug acting directly on opioid receptors and indirectly on monoaminergic receptor systems. The aim of this trial was to determine whether tramadol relieved painful polyneuropathy and reduced allodynia. The study design was randomised, double-blind, placebo-controlled and cross-over. After baseline observations, 45 patients were assigned to one of the two treatment sequences. The dose of tramadol slow-release tablets was titrated to at least 200 mg/day and at highest 400 mg/day. During the two treatment periods of 4 weeks duration, patients rated pain, paraesthesia and touch-evoked pain by use of 0-10 point numeric rating scales. Mechanical allodynia induced by stimulation with an electronic toothbrush was rated at the end of each treatment period with a similar scale. Thirty-four patients completed the study. Their ratings for pain (median 4 vs. 6, P=0.001), paraesthesia (4 vs. 6, P=0.001) and touch-evoked pain (3 vs. 5, P/=50% pain relief was 4.3 (95% confidence interval 2.4-20). It is concluded that tramadol appears to relieve both ongoing pain symptoms and the key neuropathic pain feature allodynia in polyneuropathy.

  16. Validation of the anti-bacteremic efficacy of an essential oil rinse in a Brazilian population: a cross-over study

    Directory of Open Access Journals (Sweden)

    José Roberto Cortelli

    2012-10-01

    Full Text Available This cross-over study was conducted to assess the germ-killing efficacy of an essential oil mouthrinse (EOM by determining the blood levels of microorganisms associated with induced bacteremia and investigating the prevalence of this event in Brazilians with mild-to-moderate gingivitis. Thirty four (31.19% subjects positive for bacteremia induced by chewing a ration of apple were enrolled out of 109 screened subjects (50 males and 59 females. A difference of at least 10 colony forming units between the pre- and post-insult blood samples was defined as a positive result. For the following two weeks patients underwent a toothbrush plus fluoride dentifrice normalization period, and were then scheduled for the Phase I protocol as follows. At baseline I, subjects were instructed to chew a new apple ration, had new blood samples taken before and after this oral stimulus, and were randomly assigned to an experimental essential oil (n = 17 or placebo (P mouthrinse (n = 17 treatment for 2 weeks. These procedures were repeated at the end of Phase I and then followed by a two-week wash-out period (tooth brushing with fluoride dentifrice. Bacteremia was again induced at baseline and at the end of Phase II, when subjects were crossed-over to the other EOM or placebo groups. Bacterial count differences between baseline and 2-week post-treatment (EOM versus P in the blood samples collected were assessed by analysis of covariance. Mean aerobic counts decreased by 45.8%, whereas mean anaerobic counts decreased by 63.3% after EOM treatment. After the P treatment, aerobic bacteria increased by 28.4% and anaerobic bacteria decreased by 18.5%. This study validated this novel methodology and showed that the germ-killing action of EOM significantly reduced bacteremia.

  17. The effects of consumption of bread fortified with soy bean flour on metabolic profile in type 2 diabetic women: A cross-over randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Asma Salari Moghaddam

    2014-01-01

    Full Text Available Background: Diabetes mellitus is one of the most common chronic diseases in the world and has become a major threat for global health. Recent studies reported that the soy has beneficial effects in diabetic mellitus patients. The aim of this study was to assess the effects of soybean flour fortified bread consumption on metabolic profile in type 2 diabetic women. Methods: This randomized, cross-over, controlled clinical trial was carried out in 30 type 2 diabetic women. At first, a 2-week run-in period was applied. Then, participants were randomly assigned to either intervention or control groups. Participants in the intervention group were asked to replace 120 g of soybean flour fortified bread with the same amount of their usual bread intake or other cereal products for 6 weeks. After a 4 weeks washout period, participants were crossed over for another 6 weeks. Results: Mean (±standard deviation age and body mass index of subjects was 45.7 ± 3.8 years and 29.5 ± 3.9 kg/m 2 , respectively. The results of our study showed no significant effects of soybean flour fortified bread on metabolic profile. We found a reduction in serum triglycerides (change difference: -3.7, P = 0.82, serum low-density lipoprotein-cholesterol (change difference: -11.2, P = 0.50, insulin (change difference: -3.6, P = 0.7, and homeostatic model assessment of insulin resistance (change differences: -0.57, P = 0.45 after 6 weeks but these changes were not statistically significant. No significant effects of soybean flour fortified bread on serum concentrations of fasting blood sugar, glycated hemoglobin, high-density lipoproteins and total cholesterol levels were found. Conclusions: Six weeks consumption of soybean flour fortified bread among diabetic patients had no significant effects on metabolic profile.

  18. Effect of telescopic distal extension removable partial dentures on oral health related quality of life and maximum bite force: A preliminary cross over study.

    Science.gov (United States)

    Elsyad, Moustafa Abdou; Mostafa, Aisha Zakaria

    2018-01-01

    This cross over study aimed to evaluate the effect of telescopic distal extension removable partial dentures on oral health related quality of life and maximum bite force MATERIALS AND METHODS: Twenty patients with complete maxillary edentulism and partially edentulous mandibles with anterior teeth only remaining were selected for this cross over study. All patients received complete maxillary dentures and mandibular partial removable dental prosthesis (PRDP, control). After 3 months of adaptation, PRDP was replaced with conventional telescopic partial dentures (TPD) or telescopic partial dentures with cantilevered extensions (TCPD) in a quasi-random method. Oral health related quality of life (OHRQoL) was measured using OHIP-14 questionnaire and Maximum bite force (MBF) was measured using a bite force transducer. Measurements were performed 3 months after using each of the following prostheses; PRDP, TPD, and TCPD. TCPD showed the OHIP-14 lowest scores (i.e., the highest patient satisfaction with their OHRQoL), followed by TPD, and PRDP showed the highest OHIP-14 scores (i.e., the lowest patient satisfaction with OHRQoL). TCPD showed the highest MBF (70.7 ± 3.71), followed by TPD (57.4 ± 3.43) and the lowest MBF (40.2 ± 2.20) was noted with PRDP. WITHIN The Limitations of This Study, Mandibular Telescopic Distal Extension Removable Partial Dentures with Cantilevered Extensions Were Associated with Improved Oral Health Related Quality of Life and Maximum Bite Force Compared to Telescopic or Conventional PRDP. Telescopic distal extension removable prostheses is an esthetic restoration in partially edentulous patients with free end saddle. This article describes the addition of cantilevered extensions of this prosthesis. The results showed that telescopic distal extension removable prostheses with cantilevered extensions were associated with improved oral health related quality of life and maximum bite force compared to telescopic or conventional RPDs

  19. The Effects of Consumption of Bread Fortified With Soy Bean Flour on Metabolic Profile in Type 2 Diabetic Women: A Cross-over Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Moghaddam, Asma Salari; Entezari, Mohammad Hassan; Iraj, Bijan; Askari, Gholam Reza; Maracy, Mohammad Reza

    2014-12-01

    Diabetes mellitus is one of the most common chronic diseases in the world and has become a major threat for global health. Recent studies reported that the soy has beneficial effects in diabetic mellitus patients. The aim of this study was to assess the effects of soybean flour fortified bread consumption on metabolic profile in type 2 diabetic women. This randomized, cross-over, controlled clinical trial was carried out in 30 type 2 diabetic women. At first, a 2-week run-in period was applied. Then, participants were randomly assigned to either intervention or control groups. Participants in the intervention group were asked to replace 120 g of soybean flour fortified bread with the same amount of their usual bread intake or other cereal products for 6 weeks. After a 4 weeks washout period, participants were crossed over for another 6 weeks. Mean (±standard deviation) age and body mass index of subjects was 45.7 ± 3.8 years and 29.5 ± 3.9 kg/m(2), respectively. The results of our study showed no significant effects of soybean flour fortified bread on metabolic profile. We found a reduction in serum triglycerides (change difference: -3.7, P = 0.82), serum low-density lipoprotein-cholesterol (change difference: -11.2, P = 0.50), insulin (change difference: -3.6, P = 0.7), and homeostatic model assessment of insulin resistance (change differences: -0.57, P = 0.45) after 6 weeks but these changes were not statistically significant. No significant effects of soybean flour fortified bread on serum concentrations of fasting blood sugar, glycated hemoglobin, high-density lipoproteins and total cholesterol levels were found. Six weeks consumption of soybean flour fortified bread among diabetic patients had no significant effects on metabolic profile.

  20. Early functional postoperative therapy of distal radius fracture with a dynamic orthosis: results of a prospective randomized cross-over comparative study.

    Directory of Open Access Journals (Sweden)

    Fabian M Stuby

    Full Text Available This study was conducted according to GCP criteria as a prospective randomized cross-over study. The primary goal of the study was to determine clinical findings and patient satisfaction with postoperative treatment. 29 patients with a distal radius fracture that was surgically stabilized from volar and who met the inclusion criteria were enrolled over a 12-month period. Each patient randomly received either a dorsal plaster splint or a vacuum-fit flexible but blocked orthosis applied postoperatively in the operating theatre to achieve postoperative immobilization. After one week all patients were crossed over to the complementary device maintaining the immobilization until end of week 2. After week 2 both groups were allowed to exercise wrist mobility with a physiotherapist, in the orthosis group the device was deblocked, thus allowing limited wrist mobility. After week 4 the devices were removed in both groups. Follow-up exams were performed after postoperative weeks 1, 2, 4 and 12.Results were determined after week 1 and 2 using SF 36 and a personally compiled questionnaire; after weeks 4 and 12 with a clinical check-up, calculation of ROM and the DASH Score. Comparison of the two groups showed a significant difference in ROM for volar flexion after 4 weeks, but no significant differences in DASH Score, duration of disability or x-ray findings. With regard to satisfaction with comfort and hygiene, patients were significantly more satisfied with the dynamic orthosis, and 23 of the 29 patients would prefer the flexible vacuum orthosis in future.German Clinical Trials Register (DRKS DRKS00006097.

  1. Effects of breaking up sitting on adolescents' postprandial glucose after consuming meals varying in energy: a cross-over randomised trial.

    Science.gov (United States)

    Fletcher, Elly A; Salmon, Jo; McNaughton, Sarah A; Orellana, Liliana; Wadley, Glenn D; Bruce, Clinton; Dempsey, Paddy C; Lacy, Kathleen E; Dunstan, David W

    2018-03-01

    To explore the impact of uninterrupted sitting versus sitting with resistance-type activity breaks on adolescents' postprandial glucose responses while consuming a diet varying in energy. Cross-over randomised trial. Thirteen healthy participants (16.4±1.3years) completed a four-treatment cross-over trial: (1) uninterrupted sitting+high-energy diet; (2) sitting with breaks+high-energy diet; (3) uninterrupted sitting+standard-energy diet; and (4) sitting with breaks+standard-energy diet. For all four conditions, two identical meals were consumed; at 0h and 3h. A continuous glucose monitoring system (CGM) recorded interstitial glucose concentrations every five minutes. Linear mixed models examined differences in glucose positive incremental area under the curve (iAUC) and total AUC between the sitting and diet conditions for the first meal, second meal and entire trial period. Compared to the uninterrupted sitting conditions, the breaks condition elicited a 36.0mmol/L/h (95%CI 6.6-65.5) and 35.9mmol/L/h (95%CI 6.6-65.5) lower iAUC response after the first and second meal, respectively, but not for the entire trial period or for total AUC. Compared to the standard-energy diet, the high-energy diet elicited a 55.0mmol/L/h (95%CI 25.8-84.2) and 75.7mmol/L/h (95%CI 8.6-142.7) higher iAUC response after the first meal and entire trial, respectively. Similar response to the high-energy diet were observed for total AUC. According to iAUC, interrupting sitting had a significant effect on lowering postprandial glucose for both dietary conditions, however, it was not significant when examining total AUC. Larger studies are needed to confirm these findings. ACTRN12615001145594. Copyright © 2017 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  2. Neurofeedback to improve neurocognitive functioning of children treated for a brain tumor: design of a randomized controlled double-blind trial

    International Nuclear Information System (INIS)

    Ruiter, Marieke A de; Meeteren, Antoinette YN Schouten-Van; Mourik, Rosa van; Janssen, Tieme WP; Greidanus, Juliette EM; Oosterlaan, Jaap; Grootenhuis, Martha A

    2012-01-01

    Neurotoxicity caused by treatment for a brain tumor is a major cause of neurocognitive decline in survivors. Studies have shown that neurofeedback may enhance neurocognitive functioning. This paper describes the protocol of the PRISMA study, a randomized controlled trial to investigate the efficacy of neurofeedback to improve neurocognitive functioning in children treated for a brain tumor. Efficacy of neurofeedback will be compared to placebo training in a randomized controlled double-blind trial. A total of 70 brain tumor survivors in the age range of 8 to 18 years will be recruited. Inclusion also requires caregiver-reported neurocognitive problems and being off treatment for more than two years. A group of 35 healthy siblings will be included as the control group. On the basis of a qEEG patients will be assigned to one of three treatment protocols. Thereafter patients will be randomized to receive either neurofeedback training (n=35) or placebo training (n=35). Neurocognitive tests, and questionnaires administered to the patient, caregivers, and teacher, will be used to evaluate pre- and post-intervention functioning, as well as at 6-month follow-up. Siblings will be administered the same tests and questionnaires once. If neurofeedback proves to be effective for pediatric brain tumor survivors, this can be a valuable addition to the scarce interventions available to improve neurocognitive and psychosocial functioning. ClinicalTrials.gov NCT00961922

  3. Models for the blind

    DEFF Research Database (Denmark)

    Olsén, Jan-Eric

    2014-01-01

    When displayed in museum cabinets, tactile objects that were once used in the education of blind and visually impaired people, appear to us, sighted visitors, as anything but tactile. We cannot touch them due to museum policies and we can hardly imagine what it would have been like for a blind...... person to touch them in their historical context. And yet these objects are all about touch, from the concrete act of touching something to the norms that assigned touch a specific pedagogical role in nineteenth-century blind schools. The aim of this article is twofold. First, I provide a historical...

  4. Effects of Corrective Exercise for Thoracic Hyperkyphosis on Posture, Balance, and Well-Being in Older Women: A Double-Blind, Group-Matched Design.

    Science.gov (United States)

    Jang, Hyun-Jeong; Hughes, Lynne C; Oh, Duck-Won; Kim, Suhn-Yeop

    2017-09-13

    The purpose of this study was to identify the effects of a corrective exercise for thoracic hyperkyphosis on posture, balance, and well-being in Korean community-dwelling older women. Fifty women 65 years of age and older, recruited from 2 senior centers, participated in this study. Participants were assigned to either the experimental group (EG) or the control group (CG) on the basis of convenience of location, and 22 in each were analyzed. Participants in the EG underwent a thoracic corrective exercise program 1 hour each session, twice per week for 8 weeks (a total of 16 sessions), which consisted of specific exercises to enhance breathing, thoracic mobility and stability, and awareness of thoracic alignment. The CG received education on the same thoracic corrective exercise program and a booklet of the exercises. Outcome measures included the extent of postural abnormality (angle of thoracic kyphosis, kyphosis index calculated both in relaxed- and best posture using flexicurve, the ratio of the kyphosis index calculated best posture/relaxed posture, craniovertebral angle, and tragus-to-wall distance), balance (Short Physical Performance Battery and limit of stability), and well-being (Geriatric Depression Scale Short Form and the 36-Item Short Form Health Survey [SF-36]). All data were collected by 6 blinded assessors at baseline, at 8 weeks after the completion of intervention, and at 16 weeks for follow-up. For participants of the EG, means of all parameters showed significant improvements over time (P posture, balance, and well-being in older women with thoracic hyperkyphosis. We recommend the use of the therapeutic strategies utilized in this study to enhance thoracic posture, balance, and well-being of older women with thoracic hyperkyphosis. Future research is needed to apply this exercise protocol on a larger and more diverse population.

  5. Myofascial Induction Effects on Neck-Shoulder Pain in Breast Cancer Survivors: Randomized, Single-Blind, Placebo-Controlled Crossover Design.

    Science.gov (United States)

    Castro-Martín, Eduardo; Ortiz-Comino, Lucía; Gallart-Aragón, Tania; Esteban-Moreno, Bernabé; Arroyo-Morales, Manuel; Galiano-Castillo, Noelia

    2017-05-01

    To (1) investigate the immediate effects of myofascial induction (MI), with placebo electrotherapy as a control, on perceived pain, cervical/shoulder range of motion (ROM), and mood state in breast cancer survivors (BCSs) with shoulder/arm morbidity; and (2) examine the relationships between pain modifications and cervical/shoulder ROM on the side affected by breast cancer. Randomized, single-blind, placebo-controlled crossover study. Physical therapy laboratory. BCSs (N=21) who had a diagnosis of stage I-IIIA breast cancer and had completed adjuvant therapy (except hormonal treatment). During each session, the BCSs received either an MI (fascial unwinding) intervention focused on the upper limb area following the Pilat approach or placebo pulsed shortwave therapy (control group). Each session lasted 30 minutes, and an adequate washout period of 4 weeks between sessions was established. The visual analog scale (VAS) for pain and anxiety, shoulder-cervical goniometry for ROM, the Profile of Mood States for psychological distress, and the Attitudes Towards Massage Scale were used. An analysis of covariance (ANCOVA) revealed significant time × group interactions for VAS affected arm (P=.031) but not for VAS cervical (P=.332), VAS nonaffected arm (P=.698), or VAS anxiety (P=.266). The ANCOVA also revealed significant interactions for affected shoulder flexion (P<.001), abduction (P<.001), external rotation (P=.004), and internal rotation (P=.001). Significant interactions for affected cervical rotation (P=.022) and affected cervical lateral flexion (P=.038) were also found. A significant negative correlation was found between changes in VAS affected arm and shoulder/arm internal rotation ROM (r=-.46; P=.03). A single MI session decreases pain intensity and improves neck-shoulder ROM to a greater degree than placebo electrotherapy for BCSs experiencing pain. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  6. Blind Loop Syndrome

    Science.gov (United States)

    ... of tissue that protrude through the intestinal wall (diverticulosis) Certain medical conditions, including Crohn's disease, radiation enteritis, ... History of radiation therapy to the abdomen Diabetes Diverticulosis of the small intestine Complications A blind loop ...

  7. Blindness and vision loss

    Science.gov (United States)

    ... life. Alternative Names Loss of vision; No light perception (NLP); Low vision; Vision loss and blindness Images ... ADAM Health Solutions. About MedlinePlus Site Map FAQs Customer Support Get email updates Subscribe to RSS Follow ...

  8. The blind hens’ challenge

    DEFF Research Database (Denmark)

    Sandøe, Peter; Hocking, Paul M.; Forkman, Björn

    2014-01-01

    about breeding blind hens. But we also argue that alternative views, which (for example) claim that it is important to respect the telos or rights of an animal, do not offer a more convincing solution to questions raised by the possibility of disenhancing animals for their own benefit.......Animal ethicists have recently debated the ethical questions raised by disenhancing animals to improve their welfare. Here, we focus on the particular case of breeding blind hens for commercial egg-laying systems, in order to benefit their welfare. Many people find breeding blind hens intuitively...... repellent, yet 'welfare-only' positions appear to be committed to endorsing this possibility if it produces welfare gains. We call this the 'Blind Hens' Challenge'. In this paper, we argue that there are both empirical and theoretical reasons why even those adopting 'welfare-only' views should be concerned...

  9. Issues in Traumatic Blindness.

    Science.gov (United States)

    Dale, B.

    1992-01-01

    This article discusses factors related to individuals with sudden blindness, focusing on the visually impaired client's readiness for rehabilitation, the reactions of family members and friends, and personality variables. Two cases illustrate the adjustment process and eventual rehabilitation. (DB)

  10. A Secured Application for Generating Acoustic Signal for Blind People

    OpenAIRE

    PrachiPhursutkar; Apurva Bajaj; Priyanka Veer; Tai Chormale; Prof.G.M.Bhandari

    2014-01-01

    Visionless people face many difficulties in their daily activities. This paper is basically designed to facilitate blind people for autonomous navigation. It is based on ‘image to sound’ conversion. The mobile camera is used to captures the image in front of the blind user. This image is then equated with the database and the processed information is fetched by blind user through a set of earphones. Color information of the object is also measured and it is informed...

  11. Improvement in health-related quality of life after therapy with omeprazole in patients with coronary artery disease and recurrent angina-like chest pain. A double-blind, placebo-controlled trial of the SF-36 survey

    Directory of Open Access Journals (Sweden)

    Kłopocka Maria

    2011-09-01

    Full Text Available Abstract Background Many patients with coronary artery disease (CAD have overlapping gastroenterological causes of recurrent chest pain, mainly due to gastroesophageal reflux (GER and aspirin-induced gastrointestinal tract damage. These symptoms can be alleviated by proton pump inhibitors (PPIs. The study addressed whether omeprazole treatment also affects general health-related quality of life (HRQL in patients with CAD. Study 48 patients with more than 50% narrowing of the coronary arteries on angiography without clinically overt gastrointestinal symptoms were studied. In a double-blind, placebo-controlled, cross-over study design, patients were randomized to take omeprazole 20 mg bid or a placebo for two weeks, and then crossed over to the other study arm. The SF-36 questionnaire was completed before treatment and again after two weeks of therapy. Results Patients treated with omeprazole in comparison to the subjects taking the placebo had significantly greater values for the SF-36 survey (which relates to both physical and mental health, as well as for bodily pain, general health perception, and physical health. In comparison to the baseline values, therapy with omeprazole led to a significant increase in the three summarized health components: total SF-36; physical and mental health; and in the following detailed health concept scores: physical functioning, limitations due to physical health problems, bodily pain and emotional well-being. Conclusions A double dose of omeprazole improved the general HRQL in patients with CAD without severe gastrointestinal symptoms more effectively than the placebo.

  12. Immediate acid-suppressing effects of ranitidine hydrochloride and rabeprazole sodium following initial administration and reintroduction: A randomized, cross-over study using wireless pH monitoring capsules.

    Science.gov (United States)

    Ono, Shouko; Kato, Mototsugu; Ono, Yuji; Imai, Aki; Yoshida, Takeshi; Shimizu, Yuichi; Asaka, Masahiro

    2009-04-01

    Histamine 2 receptor antagonists and proton-pump inhibitors, drugs that are widely used for the treatment of acid-related diseases, have different clinical characteristics. The objective of this study was to compare the acid-suppressing effects of ranitidine hydrochloride and those of rabeprazole sodium at the first administration and re-administration after withdrawal. The study was designed as an open-label, randomized, two-way cross-over trial. Seven Helicobacter pylori-negative healthy volunteers were enrolled in this study. Ranitidine hydrochloride (300 mg/day) or rabeprazole sodium (20 mg/day) was administered from days 1 to 7 and from days 11 to 13. The percentage of time with gastric pH sodium maintained a potent and stable effect from days 2 to 7 (ranitidine vs rabeprazole: P hydrochloride was attenuated after day 4. In addition, the effect of ranitidine hydrochloride at re-administration was attenuated (days 11, 12, and 13 vs pre-administration: not significant). In view of our observations, we expect symptoms associated with gastric acidity to be more adequately controlled with rabeprazole sodium in the short term when compared to ranitidine hydrochloride.

  13. High phenylalanine levels directly affect mood and sustained attention in adults with phenylketonuria: a randomised, double-blind, placebo-controlled, crossover trial.

    Science.gov (United States)

    ten Hoedt, Amber E; de Sonneville, Leo M J; Francois, Baudouin; ter Horst, Nienke M; Janssen, Mirian C H; Rubio-Gozalbo, M Estela; Wijburg, Frits A; Hollak, Carla E M; Bosch, Annet M

    2011-02-01

    The main debate in the treatment of Phenylketonuria (PKU) is whether adult patients need the strict phenylalanine (Phe)-restricted diet. Physicians and patients lack evidence-based guidelines to help them make well-informed choices. We have carried out the first randomised double-blind placebo-controlled trial into the effects of short-term elevation of Phe levels on neuropsychological functions and mood of adults with PKU. Nine continuously treated adults with PKU underwent two 4-week supplementation periods: one with Phe, mimicking normal dietary intake, and one with placebo in randomly allocated order via a randomisation coding list in a double-blind cross-over design. A set of neuropsychological tests (Amsterdam Neuropsychological Tasks) was administered at the end of each study period. In addition, patients and for each patient a friend or relative, completed weekly Profile of Mood States (POMS) questionnaires, evaluating the patients' mood. Phe levels were measured twice weekly. Mean plasma Phe levels were significantly higher during Phe supplementation compared with placebo (p = 0.008). Neuropsychological tests demonstrated an impairment in sustained attention during Phe supplementation (p = 0.029). Both patients and their friend or relative reported lower scores on the POMS questionnaires during Phe supplementation (p = 0.017 and p = 0.040, respectively). High plasma Phe levels have a direct negative effect on both sustained attention and on mood in adult patients with PKU. A Phe-restricted "diet for life" might be an advisable option for many.

  14. Blind Analysis in Particle Physics

    OpenAIRE

    Roodman, Aaron

    2003-01-01

    A review of the blind analysis technique, as used in particle physics measurements, is presented. The history of blind analyses in physics is briefly discussed. Next the dangers of "experimenter's bias" and the advantages of a blind analysis are described. Three distinct kinds of blind analysis in particle physics are presented in detail. Finally, the BABAR collaboration's experience with the blind analysis technique is discussed.

  15. Xylo-oligosaccharides alone or in synbiotic combination with Bifidobacterium animalis subsp. lactis induce bifidogenesis and modulate markers of immune function in healthy adults: a double-blind, placebo-controlled, randomised, factorial cross-over study.

    Science.gov (United States)

    Childs, Caroline E; Röytiö, Henna; Alhoniemi, Esa; Fekete, Agnes A; Forssten, Sofia D; Hudjec, Natasa; Lim, Ying Ni; Steger, Cara J; Yaqoob, Parveen; Tuohy, Kieran M; Rastall, Robert A; Ouwehand, Arthur C; Gibson, Glenn R

    2014-06-14

    Prebiotics, probiotics and synbiotics are dietary ingredients with the potential to influence health and mucosal and systemic immune function by altering the composition of the gut microbiota. In the present study, a candidate prebiotic (xylo-oligosaccharide, XOS, 8 g/d), probiotic (Bifidobacterium animalis subsp. lactis Bi-07, 109 colony-forming units (CFU)/d) or synbiotic (8 g XOS+109 CFU Bi-07/d) was given to healthy adults (25-65 years) for 21 d. The aim was to identify the effect of the supplements on bowel habits, self-reported mood, composition of the gut microbiota, blood lipid concentrations and immune function. XOS supplementation increased mean bowel movements per d (P= 0·009), but did not alter the symptoms of bloating, abdominal pain or flatulence or the incidence of any reported adverse events compared with maltodextrin supplementation. XOS supplementation significantly increased participant-reported vitality (P= 0·003) and happiness (P= 0·034). Lowest reported use of analgesics was observed during the XOS+Bi-07 supplementation period (P= 0·004). XOS supplementation significantly increased faecal bifidobacterial counts (P= 0·008) and fasting plasma HDL concentrations (P= 0·005). Bi-07 supplementation significantly increased faecal B. lactis content (P= 0·007), lowered lipopolysaccharide-stimulated IL-4 secretion in whole-blood cultures (P= 0·035) and salivary IgA content (P= 0·040) and increased IL-6 secretion (P= 0·009). XOS supplementation resulted in lower expression of CD16/56 on natural killer T cells (P= 0·027) and lower IL-10 secretion (P= 0·049), while XOS and Bi-07 supplementation reduced the expression of CD19 on B cells (XOS × Bi-07, P= 0·009). The present study demonstrates that XOS induce bifidogenesis, improve aspects of the plasma lipid profile and modulate the markers of immune function in healthy adults. The provision of XOS+Bi-07 as a synbiotic may confer further benefits due to the discrete effects of Bi-07 on the gut microbiota and markers of immune function.

  16. The effects of a single-dose thermogenic supplement on resting metabolic rate and hemodynamic variables in healthy females--a randomized, double-blind, placebo-controlled, cross-over trial.

    Science.gov (United States)

    Campbell, Bill I; Zito, Gina; Colquhoun, Ryan; Martinez, Nic; Kendall, Kristina; Buchanan, Laura; Lehn, Matt; Johnson, Mallory; St Louis, Courtney; Smith, Yasmin; Cloer, Brad; Pingel, Allison

    2016-01-01

    Recent investigations have identified that commercially available dietary supplements, containing a combination of thermogenic ingredients, can increase resting metabolic rate (RMR). Thermogenic dietary supplements can have a positive influence on RMR, but the magnitude can vary based on the active ingredient and/or combination of active ingredients. Additionally, further safety evaluation is needed on multi-ingredient supplements that contain caffeine, due to its potential effect on heart rate (HR) and blood pressure (BP). The purpose of this study was to examine the effects of a commercially available dietary supplement on RMR and hemodynamic variables in healthy females. 13 female participants (26.1 ± 11.3 years; 163.4 ± 9.1 cm; 63.7 ± 8.0 kg, and 24 ± 5 BMI) volunteered to participate in this investigation. Participants underwent two testing sessions separated by approximately 7 days. On their first visit, participants arrived to the laboratory after an overnight fast and underwent a baseline RMR, HR, and BP assessment. Next, each participant ingested a thermogenic dietary supplement or placebo and repeated the RMR, HR, and BP assessments at 60, 120, and 180-minutes post-ingestion. Approximately 1-week later, the alternative supplement was ingested and the assessments were repeated in the exact same manner. Data were analyzed via a 2-factor [2x4] within-subjects repeated measures analysis of variance (ANOVA). Post-hoc tests were analyzed via paired samples t-tests. Repeated measures ANOVA revealed a significant effect for time relative to raw RMR data. Post-hoc analysis revealed that the dietary supplement treatment significantly increased RMR at 60-minutes, 120-minutes, and 180-minutes post ingestion (p  0.05). Heart rate was not significantly affected at any time point with either supplement; however, main effects of treatment and time were observed for both systolic and diastolic blood pressure (p thermogenic dietary supplement treatment experienced greater elevations in RMR as compared to baseline. Due to the slight elevations in blood pressure, caution should be taken for those with increased risk for hypertension or pre-hypertension. Taken on a daily basis, thermogenic dietary supplementation may increase overall energy expenditure, potentially leading to reductions in fat mass over time.

  17. Rose Hip Powder That Contains the Natural Amount of Shells and Seeds Alleviates Pain in Osteoarthritis of the Dominant Hand—A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Clinical Trial

    DEFF Research Database (Denmark)

    Winther, Kaj; Campbell-Tofte, Joan I A; Hansen, Peter

    2013-01-01

    Aim: A standardized preparation of seeds and shells of selected sub-species of Rosa canina L, trade name Hyben Vital, reduces discomfort from osteoarthritis of the knee and hip. This study aims to investigate the impact of the same rose-hip powder (RHP) on discomfort and the consumption of rescue...

  18. Rose Hip Powder That Contains the Natural Amount of Shells and Seeds Alleviates Pain in Osteoarthritis of the Dominant Hand—A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Clinical Trial

    DEFF Research Database (Denmark)

    Winther, Kaj; Campbell-Tofte, Joan I A; Hansen, Peter

    2013-01-01

    scale, focusing on 16 different daily activities of the hand. The consumption of rescue medication was also calculated at the beginning and at the end of each study phase. Data are based on the intention to treat. Results: At the end of Phase 1, 90% of patients in the group receiving RHP first (group A...

  19. Effect of oral administration of freshly pressed juice of Echinacea purpurea on the number of various subpopulations of B- and T-lymphocytes in healthy volunteers: results of a double-blind, placebo-controlled cross-over study

    DEFF Research Database (Denmark)

    Schwarz, Evelyn; Parlesak, Alexandr; Henneicke-von-Zeppelin, H. H.

    2005-01-01

    determined by using Flow-cytometry. RESULTS: After 1 week of treatment with verum the mean value of the total number of lymphocytes decreased slightly (-6%, p = 0.033) compared to the initial value. Treatment for 1 and 2 weeks with EPP had only minor effects on two of the 12 subtypes of lymphocytes...

  20. Habitual dietary fibre intake influences gut microbiota response to an inulin-type fructan prebiotic:a randomised, double-blind, placebo-controlled, cross-over, human intervention study

    OpenAIRE

    Healey, Genelle; Murphy, Rinki; Butts, Chrissie; Brough, Louise; Whelan, Kevin; Coad, Jane

    2018-01-01

    Dysbiotic gut microbiota have been implicated in human disease. Diet-based therapeutic strategies have been used to manipulate the gut microbiota towards a more favourable profile. However, it has been demonstrated that large inter-individual variability exists in gut microbiota response to a dietary intervention. The primary objective of this study was to investigate whether habitually low dietary fibre (LDF) v. high dietary fibre (HDF) intakes influence gut microbiota response to an inulin-...

  1. Lactobacillus reuteri supplements do not affect salivary IgA or cytokine levels in healthy subjects: A randomized, double-blind, placebo-controlled cross-over trial

    DEFF Research Database (Denmark)

    Jørgensen, Mette Rose; Keller, Mette Kirstine; Kragelund, Camilla

    2016-01-01

    Objectives: To evaluate the effect of daily ingestion of probiotic lactobacilli on the levels of secretory IgA (sIgA) and selected cytokines in whole saliva of healthy young adults. Materials and methods: The study group consisted of 47 healthy adults (18–32 years) who volunteered for a randomized...

  2. Design of Randomized, double-blind, Evaluation in secondary Stroke Prevention comparing the EfficaCy and safety of the oral Thrombin inhibitor dabigatran etexilate vs. acetylsalicylic acid in patients with Embolic Stroke of Undetermined Source (RE-SPECT ESUS).

    Science.gov (United States)

    Diener, Hans-Christoph; Easton, J Donald; Granger, Christopher B; Cronin, Lisa; Duffy, Christine; Cotton, Daniel; Brueckmann, Martina; Sacco, Ralph L

    2015-12-01

    Cryptogenic ischemic strokes constitute 20-30% of ischemic strokes, the majority of which are embolic strokes of undetermined source. The standard preventive treatment in these patients is usually acetylsalicylic acid. The Randomized, double-blind, Evaluation in secondary Stroke Prevention comparing the EfficaCy and safety of the oral Thrombin inhibitor dabigatran etexilate vs. acetylsalicylic acid in patients with Embolic Stroke of Undetermined Source (RE-SPECT ESUS) is designed to determine whether the oral thrombin inhibitor dabigatran, taken within three-months after embolic stroke of undetermined source, is superior to acetylsalicylic acid for prevention of recurrent stroke and to characterize the safety of dabigatran in this setting. Prospective, randomized, double-blind, multicenter trial in approximately 6000 patients and 550 centers with embolic stroke of undetermined source. Subjects are randomized to dabigatran or acetylsalicylic acid and treated for an expected minimum of six-months and up to approximately three-years. It is an event-driven trial aiming for 353 adjudicated primary outcome events. The primary efficacy outcome is time to first recurrent stroke (ischemic, hemorrhagic, or unspecified). Key secondary outcomes are time to first ischemic stroke and time to first occurrence in the composite outcome of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death. The primary safety outcome is major hemorrhage, including symptomatic intracranial hemorrhage. Acetylsalicylic acid is the most common antithrombotic given to patients with embolic strokes of undetermined source to reduce recurrence risk. This trial will determine whether anticoagulation with dabigatran is more effective than acetylsalicylic acid, and acceptably safe. © 2015 World Stroke Organization.

  3. The cost-effectiveness analysis of JinQi Jiangtang tablets for the treatment on prediabetes: a randomized, double-blind, placebo-controlled, multicenter design.

    Science.gov (United States)

    Sun, Xiao; Guo, Liping; Shang, Hongcai; Ren, Ming; Wang, Yue; Huo, Da; Lei, Xiang; Wang, Hui; Zhai, Jingbo

    2015-11-03

    At present, diabetes is a chronic disease of great cost and heavy burdens. The International Diabetes Federation has repeatedly warned that by 2025, the global number of diabetics would rise to 333 million from 194 million in 2003. Although the occurrence of diabetes in developing countries is lower, China has a large population, so that the number of cases is increased. At the same time, more people have prediabetes, a growing health concern where a large percentage of the patients develop full type 2 diabetes. In addition, the patients of diabetes easily incur complications such as blindness, kidney failure, and cardiovascular diseases that can seriously affect the patients' quality of life and cause great economic burdens to family and society. Therefore, effective interventions for prediabetes are needed to prevent or delay the occurrence and development of diabetes. A randomized controlled trial that was assessed with pharmacoeconomic methods was undertaken in this study. The study term was 24 months (12 months for the intervention and 12 months for follow up). Four hundred participants, recruited from four cities in China: Beijing, Tianjin, Xian, and Naning, were randomized to the treatment group (JQJT tablets) and the control group (placebo). Participants included in this study had been diagnosed with prediabetes according to the criteria for western medicine and Traditional Chinese Medicine (TCM). The end-point effectiveness indexes included the incidence of diabetes and the reversion rate. The drug costs and lifestyle intervention costs were included in the total costs. The study used the cost-effectiveness analysis to discuss the economic advantage of the JQJT tablets. The outcomes of the study contained 2 sections,namely clinical outcomes and cost-effectiveness analysis outcomes. The clinical outcomes: the treatment group and control group had no significant statistical difference P> 0.05) on the baseline of situation; Jinqi Jiangtang tablet effectively

  4. A Comparison of Regular Consumption of Fresh Lean Pork, Beef and Chicken on Body Composition: A Randomized Cross-Over Trial

    Science.gov (United States)

    Murphy, Karen J.; Parker, Barbara; Dyer, Kathryn A.; Davis, Courtney R.; Coates, Alison M.; Buckley, Jonathan D.; Howe, Peter R. C.

    2014-01-01

    Pork is the most widely eaten meat in the world and recent evidence shows that diets high in pork protein, with and without energy restriction, may have favourable effects on body composition. However, it is unclear whether these effects on body composition are specific to pork or whether consumption of other high protein meat diets may have the same benefit. Therefore we aimed to compare regular consumption of pork, beef and chicken on indices of adiposity. In a nine month randomised open-labelled cross-over intervention trial, 49 overweight or obese adults were randomly assigned to consume up to 1 kg/week of pork, chicken or beef, in an otherwise unrestricted diet for three months, followed by two further three month periods consuming each of the alternative meat options. BMI and waist/hip circumference were measured and body composition was determined using dual energy x-ray absorptiometry. Dietary intake was assessed using three day weighed food diaries. Energy expenditure was estimated from activity diaries. There was no difference in BMI or any other marker of adiposity between consumption of pork, beef and chicken diets. Similarly there were no differences in energy or nutrient intakes between diets. After three months, regular consumption of lean pork meat as compared to that of beef and chicken results in similar changes in markers of adiposity of overweight and obese Australian middle-aged men and women. PMID:24534884

  5. Influence of neural mobilization of lower limbs on the functional performance and dynamic balance in asymptomatic individuals: a cross-over randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Nunes Guilherme S.

    2017-12-01

    Full Text Available Purpose. To verify the influence of neural mobilization (NM applied to the lower limbs on functional performance and dynamic balance in asymptomatic individuals. Methods. The total of 30 asymptomatic participants (15 women and 15 men; age, 30.1 ± 6.7 years; height, 1.70 ± 0.1 m; body mass, 73.1 ± 13.4 kg were enrolled in this cross-over randomized controlled trial. The participants received NM of the femoral, sciatic, and tibial nerves, as well as static stretching (SS of the following muscles: hamstring, lumbar, piriformis, hip adductors, hip flexors, quadriceps, and triceps surae. The order of applying NM and SS was randomly decided and the interventions were performed at least 48 hours apart. Functional performance was measured by performance in vertical jump (VJ and dynamic balance was measured with the Star Excursion Balance Test (SEBT. Results. There were no differences between NM and SS for height (cm in VJ (p = 0.16 or in the distance reached (% in the SEBT, normalized by lower limb length (dominant limb: anterior, p = 0.35; posterolateral, p = 0.69; posteromedial, p = 0.50 / non-dominant limb: anterior, p = 0.68; posterolateral, p = 1.00; posteromedial, p = 0.77. Conclusions. NM did not exert any influence on functional performance or dynamic balance. Thereby, having no positive or negative impact on performance, NM can be used at any time of treatment.

  6. Effectiveness of an ergonomic intervention on work-related posture and low back pain in video display terminal operators: a 3 year cross-over trial.

    Science.gov (United States)

    Pillastrini, Paolo; Mugnai, Raffaele; Bertozzi, Lucia; Costi, Stefania; Curti, Stefania; Guccione, Andrew; Mattioli, Stefano; Violante, Francesco S

    2010-05-01

    This study investigated the effectiveness of a workstation ergonomic intervention for work-related posture and low back pain (LBP) in Video Display Terminal (VDT) workers. 100 VDT workers were selected to receive the ergonomic intervention, whereas 100 were assigned to a control group. The two groups were then crossed-over after 30 months from baseline. Follow-ups were repeated at 5, 12, and 30 months from baseline and then at 6 months following crossover. Work-related posture and LBP point-prevalence using the Rapid Entire Body Assessment method and a Pain Drawing, respectively. The ergonomic intervention at the workstation improved work-related posture and was effective in reducing LBP point-prevalence both in the first study period and after crossover, and these effects persisted for at least 30 months. In conclusion, our findings contribute to the evidence that individualized ergonomic interventions may be able to improve work-related posture and reduce LBP for VDT workers. Copyright (c) 2009 Elsevier Ltd. All rights reserved.

  7. A Comparison of Regular Consumption of Fresh Lean Pork, Beef and Chicken on Body Composition: A Randomized Cross-Over Trial

    Directory of Open Access Journals (Sweden)

    Karen J. Murphy

    2014-02-01

    Full Text Available Pork is the most widely eaten meat in the world and recent evidence shows that diets high in pork protein, with and without energy restriction, may have favourable effects on body composition. However, it is unclear whether these effects on body composition are specific to pork or whether consumption of other high protein meat diets may have the same benefit. Therefore we aimed to compare regular consumption of pork, beef and chicken on indices of adiposity. In a nine month randomised open-labelled cross-over intervention trial, 49 overweight or obese adults were randomly assigned to consume up to 1 kg/week of pork, chicken or beef, in an otherwise unrestricted diet for three months, followed by two further three month periods consuming each of the alternative meat options. BMI and waist/hip circumference were measured and body composition was determined using dual energy x-ray absorptiometry. Dietary intake was assessed using three day weighed food diaries. Energy expenditure was estimated from activity diaries. There was no difference in BMI or any other marker of adiposity between consumption of pork, beef and chicken diets. Similarly there were no differences in energy or nutrient intakes between diets. After three months, regular consumption of lean pork meat as compared to that of beef and chicken results in similar changes in markers of adiposity of overweight and obese Australian middle-aged men and women.

  8. The Satiating Properties of Pork are not Affected by Cooking Methods, Sousvide Holding Time or Mincing in Healthy Men—A Randomized Cross-Over Meal Test Study

    Science.gov (United States)

    Kehlet, Ursula; Mitra, Bhaskar; Aaslyng, Margit D.

    2017-01-01

    Low temperature long time (LTLT) sous-vide cooking may modify meat proteins in a way that could promote satiety. We investigated the effects of (1) cooking method (LTLT 58 °C vs. oven 160 °C), (2) LTLT holding time (17 h vs. 72 min), and (3) pork structure, LTLT 58 °C for 17 h (minced vs. roast) on appetite regulation and in vitro protein digestibility. In a cross-over study, 37 healthy men consumed four meals containing pork: LTLT-cooked roast, 58 °C, 72 min; LTLT-cooked roast, 58 °C, 17 h; and, oven-cooked roast, 160 °C to a core temperature of 58 °C and LTLT-cooked minced patties, 58 °C, 17 h. Ad libitum energy intake (EI) after three hours was the primary endpoint. Moreover, subjective appetite sensations were assessed. Protein digestibility was determined in an in vitro simulated digestion model. Ad libitum EI did not differ between the meals. Furthermore, appetite ratings were not clearly affected. LTLT cooking for 72 min increased the proteolytic rate in the early gastric phase during digestion as compared to LTLT cooking for 17 h or oven cooking. In conclusion, LTLT cooking, LTLT holding time, and pork structure did not affect ad libitum EI. However, LTLT cooking at 58 °C for 72 min seemed to enhance in vitro protein digestibility. PMID:28846600

  9. The satiating properties of pork are not affected by cooking methods, sousvide holding time or mincing in healthy men - a randomized cross-over meal test study

    DEFF Research Database (Denmark)

    Kehlet, Ursula; Mitra, Bhaskar; Ruiz Carrascal, Jorge

    2017-01-01

    Low temperature long time (LTLT) sous-vide cooking may modify meat proteins in a way that could promote satiety. We investigated the effects of (1) cooking method (LTLT 58 °C vs. oven 160 °C), (2) LTLT holding time (17 h vs. 72 min), and (3) pork structure, LTLT 58 °C for 17 h (minced vs. roast......) on appetite regulation and in vitro protein digestibility. In a cross-over study, 37 healthy men consumed four meals containing pork: LTLT-cooked roast, 58 °C, 72 min; LTLT-cooked roast, 58 °C, 17 h; and, oven-cooked roast, 160 °C to a core temperature of 58 °C and LTLT-cooked minced patties, 58 °C, 17 h. Ad...... libitum energy intake (EI) after three hours was the primary endpoint. Moreover, subjective appetite sensations were assessed. Protein digestibility was determined in an in vitro simulated digestion model. Ad libitum EI did not differ between the meals. Furthermore, appetite ratings were not clearly...

  10. The effects of transcutaneous electrical nerve stimulation on strength, proprioception, balance and mobility in people with stroke: a randomized controlled cross-over trial.

    Science.gov (United States)

    Tyson, Sarah F; Sadeghi-Demneh, Ebrahim; Nester, Christopher J

    2013-09-01

    To investigate the feasibility and potential efficacy of 'activeTENS' (that is transcutaneous electrical nerve stimulation (TENS) during everyday activities) by assessing the immediate effects on strength, proprioception, balance/falls risk and mobility after stroke. A paired-sample randomized cross-over trial. Twenty-nine mobile chronic stroke survivors with no pre-existing conditions limiting balance or mobility or contra-indications to TENS. University clinical research facility. A single session of 'activeTENS' delivered via a 'sock electrode' (70-130 Hz, five second cycle) plus a session of control treatment (wearing the sock electrode with no stimulation), lasting approximately two hours in total. Dorsiflexor and plantarflexor strength and proprioception using an isokinetic dyanometer, balance and falls risk (Standing Forward Reach Test) and gait speed (10-m walk test). All participants tolerated 'active TENS'. Most parameters improved during stimulation with activeTENS; balance (p = 0.009), gait speed (p = 0.002), plantarflexor strength (p = 0.008) and proprioception of plantarflexion (p = 0.029), except dorsiflexor strength (p = 0.194) and dorsiflexion proprioception (p = 0.078). The results provide initial evidence of the potential of 'active TENS' to benefit physical function after stroke which warrants further phase II trials to develop the intervention. Concerns that stimulation could have a detrimental impact on balance and increase risk of falls were not supported.

  11. Effects of whole-grain rye porridge with added inulin and wheat gluten on appetite, gut fermentation and postprandial glucose metabolism: a randomised, cross-over, breakfast study.

    Science.gov (United States)

    Lee, Isabella; Shi, Lin; Webb, Dominic-Luc; Hellström, Per M; Risérus, Ulf; Landberg, Rikard

    2016-12-01

    Whole-grain rye foods reduce appetite, insulin and sometimes glucose responses. Increased gut fermentation and plant protein may mediate the effect. The aims of the present study were to investigate whether the appetite-suppressing effects of whole-grain rye porridge could be enhanced by replacing part of the rye with fermented dietary fibre and plant protein, and to explore the role of gut fermentation on appetite and metabolic responses over 8 h. We conducted a randomised, cross-over study using two rye porridges (40 and 55 g), three 40-g rye porridges with addition of inulin:gluten (9:3; 6:6; 3:9 g) and a refined wheat bread control (55 g), served as part of complete breakfasts. A standardised lunch and an ad libitum dinner were served 4 and 8 h later, respectively. Appetite, breath hydrogen and methane, glucose, insulin and glucagon-like peptide-1 (GLP-1) responses were measured over 8 h. Twenty-one healthy men and women, aged 23-60 years, with BMI of 21-33 kg/m2 participated in this study. Before lunch, the 55-g rye porridges lowered hunger by 20 % and desire to eat by 22 % and increased fullness by 29 % compared with wheat bread (Pinulin and gluten compared with plain rye porridges.

  12. The Mapleson C circuit clears more secretions than the Laerdal circuit during manual hyperinflation in mechanically-ventilated patients: a randomised cross-over trial.

    Science.gov (United States)

    Hodgson, Carol; Ntoumenopoulos, George; Dawson, Heather; Paratz, Jennifer

    2007-01-01

    What is the effect of the Mapleson C circuit compared with the Laerdal circuit in removing secretions and improving ventilation and gas exchange during manual hyperinflation? Prospective, randomised, cross-over trial. Twenty patients from a tertiary-level intensive care unit who were being mechanically ventilated. Manual hyperinflation in side-lying with both the Mapleson C or Laerdal circuit on the one day, one circuit in the morning and one in the afternoon, with a washout period of at least three hours between them. Secretion clearance was measured as sputum weight, ventilation was measured as respiratory compliance and tidal volume, while gas exchange was measured as oxygenation and CO2 removal. The Mapleson C circuit cleared 0.89 g (95% CI 0.80 to 1.15) more secretions than the Laerdal circuit (p Mapleson C and the Laerdal circuits on respiratory compliance (p = 0.81), tidal volume (p = 0.45), oxygenation (p = 0.28), or CO2 removal (p = 0.17). Although more secretions were cleared using the Mapleson C compared with the Laerdal circuit in this study, this had no consequence in terms of oxygenation and compliance only trended to improve. As the study was underpowered the clinical significance of these findings is not clear.

  13. Is the timing of caloric intake associated with variation in diet-induced thermogenesis and in the metabolic pattern? A randomized cross-over study.

    Science.gov (United States)

    Bo, S; Fadda, M; Castiglione, A; Ciccone, G; De Francesco, A; Fedele, D; Guggino, A; Parasiliti Caprino, M; Ferrara, S; Vezio Boggio, M; Mengozzi, G; Ghigo, E; Maccario, M; Broglio, F

    2015-12-01

    Food-induced thermogenesis is generally reported to be higher in the morning, although contrasting results exist because of differences in experimental settings related to the preceding fasting, exercise, sleeping and dieting. To definitively answer to this issue, we compared the calorimetric and metabolic responses to identical meals consumed at 0800 hours and at 2000 hours by healthy volunteers, after standardized diet, physical activity, duration of fast and resting. Twenty subjects (age range 20-35 years, body mass index=19-26 kg m(-)(2)) were enrolled to a randomized cross-over trial. They randomly received the same standard meal in the morning and, 7 days after, in the evening, or vice versa. A 30-min basal calorimetry was performed; a further 60-min calorimetry was done 120-min after the beginning of the meal. Blood samples were drawn every 30-min for 180-min. General linear models, adjusted for period and carry-over, were used to evaluate the 'morning effect', that is, the difference of morning delta (after-meal minus fasting values) minus evening delta (after-meal minus fasting values) of the variables. Fasting resting metabolic rate (RMR) did not change from morning to evening; after-meal RMR values were significantly higher after the morning meal (1916; 95% confidence interval (CI)=1792, 2041 vs 1756; 1648, 1863 kcal; Ptiming of meals should probably be considered when nutritional recommendations are given.

  14. The Effect of Body Position on Pain Due to Nasal Continuous Positive Airway Pressure (CPAP in Premature Neonates: A Cross-Over Clinical Trial Study

    Directory of Open Access Journals (Sweden)

    Mahnaz Jabraeili

    2018-01-01

    Full Text Available Background The most common cause of admission to neonatal intensive care units (NICU is respiratory distress syndrome. One of the respiratory assistance methods is using nasal continuous positive airway pressure (CPAP. Regarding the importance of pain control which is one of the major priorities in neonatal nursing care, this study aimed to evaluate the effect of body position on pain due to nasal CPAP in premature neonates. Materials and Methods In this cross-over clinical trial, 50 premature neonates who were receiving nasal CPAP admitted to the NICU of Imam Reza Hospital, Kermanshah, Iran, were included. The neonates were randomly placed at three body positions (fetal, supine, and prone positions. Pain was measured by Astrid Lindgren Children’s Hospital Pain Scale Neonates (ALPS-Neo pain assessment scale. The collected data were analyzed using the SPSS software (Version 22.0. Results Significant difference existed regarding pain of nasal CPAP among body positions (p< 0.001. Mean (SD pain was 5.15 (0.822 in fetal position, 6.260 (0.747 in prone position and 7.326 (0.792 in supine position. Conclusion Body positioning in premature neonates under nasal CPAP in NICU can be effective as a non-pharmacologic method in alleviating pain due to nasal CPAP. Among the studied positions, the lowest pain score was seen in fetal position.

  15. The amelioration of plasma lipids by Korean traditional confectionery in middle-aged women: A cross-over study with western cookie.

    Science.gov (United States)

    Hong, Sun Hee; Kim, Mijeong; Woo, Minji; Noh, Jeong Sook; Lee, JaeHwan; Chung, Lana; Song, Yeong Ok

    2016-12-01

    The purpose of this study was to examine whether plasma lipid profiles are affected differently by snack kinds with equal calorific values. We compared a Korean traditional confectionery ( dasik ) with Western confectionery (cookie) in this regard. Controlled cross-over study consisted of two 3-week snack intake phases and for separating, a 2-week washout period (3-2-3) was carried out with 30 healthy women aged between 40-59 years old. Brown rice based Korean traditional confectionery and wheat flour based Western confectionery were used. The participants consumed either dasik or cookie every day for 3 weeks, providing 93 kcal a day. The total cholesterol (TC) in the dasik group had decreased significantly after 3 weeks ( P < 0.05). Furthermore, in the dasik group, reduction in TC and low-density lipoprotein-cholesterol were greater than those in the cookie group ( P < 0.05). Prioritizing functional snacks like dasik improves plasma lipid profiles; this may be useful information for individuals who cannot refrain from snacking.

  16. Effects of chocolate-based products intake on blood glucose, insulin and ghrelin levels and on satiety in young people: a cross-over experimental study.

    Science.gov (United States)

    Zhang, Cai-Xia; Long, Wei-Qing; Ye, Yan-Bin; Lu, Min-Shan; Zhang, Nai-Qi; Xu, Ming; Huang, Jing; Su, Yi-Xiang

    2018-02-19

    This cross-over experimental study aimed to examine the effects of filled chocolate consumption on blood glucose, insulin and ghrelin levels in 20 volunteers. After a one-week run-in period, study participants consumed two chocolate-based products, the tested biscuit or water for 21 days as a morning snack. After a two-week wash-out period, participants consumed another tested food for another 21 days. Each participant consumed all four test foods within an 18-week period. The participants' blood insulin increased slowly after two chocolate-based products intakes on the first day and satiety levels after eating chocolate-based products and the tested biscuit were the same. Chocolate consumption for three weeks had no adverse effects on blood glucose, insulin or ghrelin levels. In conclusion, compared to eating the tested biscuit, 21-day consumption of the tested chocolate-based products had no adverse effects on the blood glucose, insulin and ghrelin levels. This trial is registered with chictr.org.cn: ChiCTR-IOR-16009525.

  17. Combined caffeine and bright light reduces dangerous driving in sleep-deprived healthy volunteers: a pilot cross-over randomised controlled trial.

    Science.gov (United States)

    Hartley, S L; Barbot, F; Machou, M; Lejaille, M; Moreau, B; Vaugier, I; Lofaso, F; Quera-Salva, M A

    2013-06-01

    To explore the effects of caffeine and bright light therapy on simulated nighttime driving in sleep-deprived healthy volunteers. Twelve male healthy volunteers aged 20 to 50 years participated in a randomized cross-over study of simulated nighttime driving at a sleep laboratory, followed by recovery sleep with polysomnography at home. The volunteers received variable combinations of caffeine 200mg (C+), caffeine placebo (C-), bright light 10,000 lux (L+), and bright light placebosleep. Without treatment, lane drifting increased throughout the night, and objective and subjective vigilance declined. Paired comparisons showed that lane drifting was significantly worse at 6 a.m. and at 4 a.m. than at 1:30 a.m. There was a global treatment effect on lane drifting. Lane drifting at 6 a.m. was significantly decreased with C+L+ compared to C-L-. Bright light therapy combined with caffeine administered at 1 a.m. decreased lane drifting by healthy volunteers during simulated nighttime driving. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  18. A comparison of regular consumption of fresh lean pork, beef and chicken on body composition: a randomized cross-over trial.

    Science.gov (United States)

    Murphy, Karen J; Parker, Barbara; Dyer, Kathryn A; Davis, Courtney R; Coates, Alison M; Buckley, Jonathan D; Howe, Peter R C

    2014-02-14

    Pork is the most widely eaten meat in the world and recent evidence shows that diets high in pork protein, with and without energy restriction, may have favourable effects on body composition. However, it is unclear whether these effects on body composition are specific to pork or whether consumption of other high protein meat diets may have the same benefit. Therefore we aimed to compare regular consumption of pork, beef and chicken on indices of adiposity. In a nine month randomised open-labelled cross-over intervention trial, 49 overweight or obese adults were randomly assigned to consume up to 1 kg/week of pork, chicken or beef, in an otherwise unrestricted diet for three months, followed by two further three month periods consuming each of the alternative meat options. BMI and waist/hip circumference were measured and body composition was determined using dual energy x-ray absorptiometry. Dietary intake was assessed using three day weighed food diaries. Energy expenditure was estimated from activity diaries. There was no difference in BMI or any other marker of adiposity between consumption of pork, beef and chicken diets. Similarly there were no differences in energy or nutrient intakes between diets. After three months, regular consumption of lean pork meat as compared to that of beef and chicken results in similar changes in markers of adiposity of overweight and obese Australian middle-aged men and women.

  19. The Tulip GT® airway versus the facemask and Guedel airway: a randomised, controlled, cross-over study by Basic Life Support-trained airway providers in anaesthetised patients.

    Science.gov (United States)

    Shaikh, A; Robinson, P N; Hasan, M

    2016-03-01

    We performed a randomised, controlled, cross-over study of lung ventilation by Basic Life Support-trained providers using either the Tulip GT® airway or a facemask with a Guedel airway in 60 anaesthetised patients. Successful ventilation was achieved if the provider produced an end-tidal CO2 > 3.5 kPa and a tidal volume > 250 ml in two of the first three breaths, within 60 sec and within two attempts. Fifty-seven (95%) providers achieved successful ventilation using the Tulip GT compared with 35 (58%) using the facemask (p Tulip GT and facemask, the mean (SD) end-tidal CO2 was 5.0 (0.7) kPa vs 2.5 (1.5) kPa, tidal volume was 494 (175) ml vs 286 (186) ml and peak inspiratory pressure was 18.3 (3.4) cmH2 O vs 13.6 (7) cmH2 O respectively (all p Tulip GT airway. These results are similar to a previous manikin study using the same protocol, suggesting a close correlation between human and manikin studies for this airway device. We conclude that the Tulip GT should be considered as an adjunct to airway management both within and outside hospitals when ventilation is being undertaken by Basic Life Support-trained airway providers. © 2015 The Association of Anaesthetists of Great Britain and Ireland.

  20. Design of the Park-in-Shape study: a phase II double blind randomized controlled trial evaluating the effects of exercise on motor and non-motor symptoms in Parkinson's disease.

    Science.gov (United States)

    van der Kolk, Nicolien M; Overeem, Sebastiaan; de Vries, Nienke M; Kessels, Roy P C; Donders, Rogier; Brouwer, Marc; Berg, Daniela; Post, Bart; Bloem, Bas R

    2015-04-16

    Parkinson's disease (PD) is a neurodegenerative disorder with a wide range of motor and non-motor symptoms. Despite optimal medical management, PD still results in a high disability rate and secondary complications and many patients lead a sedentary lifestyle, which in turn is also associated with a higher co-morbidity and mortality. Exercise has been explored as a strategy to reduce secondary complications and results suggests that it not only provides general health benefits, but may also provide symptomatic relief. If this holds true exercise would be a very attractive addition to the therapeutic arsenal in PD. The supportive evidence remains incomplete. Here, we describe the design of the Park-in-Shape study, which primarily aims to evaluate whether aerobic exercise affords clinically relevant improvements in motor symptoms in sedentary PD patients. A specific new element is the introduction of gaming to optimize compliance to the exercise intervention. The Park-in-Shape study is a randomized controlled, assessor- and patient-blinded single center study. Two parallel groups will include a total of 130 patients, receiving either aerobic exercise on a home trainer equipped with gaming elements ("exergaming"), or a non-aerobic intervention (stretching, flexibility and relaxation exercises). Both groups are supported by a specifically designed motivational app that uses gaming elements to stimulate patients to exercise and rewards them after having completed the exercise. Both interventions are delivered at home at least 3 times a week for 30-45 minutes during 6 months. Eligible patients are community-dwelling, sedentary patients diagnosed with mild-moderate PD. The primary outcome is the MDS-UPDRS motor score (tested in the off state) after 6 months. Secondary outcomes include various motor and non-motor symptoms, quality of life, physical fitness, and adherence. This Park-in-Shape study is anticipated to answer the question whether high intensity aerobic

  1. Selected Sewing Machines Evaluated for Use by Blind Students.

    Science.gov (United States)

    MacDonald, Nora M.; Huffman, Vera J.

    1982-01-01

    Describes a study using blind high school students and a repeated subject design to evaluate six selected sewing machines. The major purposes were to compare and analyze specific sewing machine features and to determine the machines' overall ease of performance when operated by blind students. (CT)

  2. Eye diseases and blindness in Adjumani refugee settlement camps ...

    African Journals Online (AJOL)

    Objectives: To determine the prevalence and causes of the blindness and ocular morbidity amongst Sudanese refugees; to prioritise and provide eye care services to the refugees and; to device administrative strategies and logistics of prevention and control of blinding diseases among the refugees. Design: A mobile ...

  3. Design paper: The CapOpus trial: A randomized, parallel-group, observer-blinded clinical trial of specialized addiction treatment versus treatment as usual for young patients with cannabis abuse and psychosis

    Directory of Open Access Journals (Sweden)

    Gluud Christian

    2008-07-01

    Full Text Available Abstract Background A number of studies indicate a link between cannabis-use and psychosis as well as more severe psychosis in those with existing psychotic disorders. There is currently insufficient evidence to decide the optimal way to treat cannabis abuse among patients with psychosis. Objectives The major objective for the CapOpus trial is to evaluate the additional effect on cannabis abuse of a specialized addiction treatment program adding group treatment and motivational interviewing to treatment as usual. Design The trial is designed as a randomized, parallel-group, observer-blinded clinical trial. Patients are primarily recruited through early-psychosis detection teams, community mental health centers, and assertive community treatment teams. Patients are randomized to one of two treatment arms, both lasting six months: 1 specialized addiction treatment plus treatment as usual or 2 treatment as usual. The specialized addiction treatment is manualized and consists of both individual and group-based motivational interviewing and cognitive behavioral therapy, and incorporates both the family and the case manager of the patient. The primary outcome measure will be changes in amount of cannabis consumption over time. Other outcome measures will be psychosis symptoms, cognitive functioning, quality of life, social functioning, and cost-benefit analyses. Trial registration ClinicalTrials.gov NCT00484302.

  4. Optimal blind quantum computation.

    Science.gov (United States)

    Mantri, Atul; Pérez-Delgado, Carlos A; Fitzsimons, Joseph F

    2013-12-06

    Blind quantum computation allows a client with limited quantum capabilities to interact with a remote quantum computer to perform an arbitrary quantum computation, while keeping the description of that computation hidden from the remote quantum computer. While a number of protocols have been proposed in recent years, little is currently understood about the resources necessary to accomplish the task. Here, we present general techniques for upper and lower bounding the quantum communication necessary to perform blind quantum computation, and use these techniques to establish concrete bounds for common choices of the client's quantum capabilities. Our results show that the universal blind quantum computation protocol of Broadbent, Fitzsimons, and Kashefi, comes within a factor of 8/3 of optimal when the client is restricted to preparing single qubits. However, we describe a generalization of this protocol which requires exponentially less quantum communication when the client has a more sophisticated device.

  5. OCULAR PROFILE OF VISUALLY IMPAIRED CHILDREN IN SCHOOLS FOR THE BLIND IN NORTH INDIA

    Directory of Open Access Journals (Sweden)

    Arun Bhatt

    2016-12-01

    Full Text Available BACKGROUND India shoulders the world’s largest burden of childhood blindness. The pattern, causes and prevalence of blindness in children are changing in response to socioeconomic development. Examination of children in schools for blind provides data on the causes of blindness in children. In order to design effective prevention of blindness programs, information on major causes of blindness in children is required. The aim of the study is to study the ocular profile of severe visual impairment and blindness in children from schools for the blind in North India. MATERIALS AND METHODS A total of 174 students in seven registered schools for the blind in Punjab, North India, were examined of which 172 were below 16 years of age and were included in the study. Visual loss was categorised according to WHO criteria for classification of blindness. The World Health Organizations program for the prevention of blindness (WHO/PBL eye examination record for children with blindness was used to record the findings. The need for optical, surgical or medical interventions was recorded and the visual prognosis was assessed. RESULTS It was found that 36.74% children had potentially avoidable causes of blindness. Preventable causes of blindness were seen in 16.26% children and treatable causes in 20.48% children. CONCLUSION A wider availability of specialist ophthalmic services is needed for the treatable causes of childhood blindness. Optical and low vision services are also important in the management of children with otherwise untreatable causes of visual loss.

  6. Effects of recommendations to follow the Dietary Approaches to Stop Hypertension (DASH) diet v. usual dietary advice on childhood metabolic syndrome: a randomised cross-over clinical trial.

    Science.gov (United States)

    Saneei, Parvane; Hashemipour, Mahin; Kelishadi, Roya; Rajaei, Somayeh; Esmaillzadeh, Ahmad

    2013-12-01

    The effects of the Dietary Approaches to Stop Hypertension (DASH) eating plan on childhood metabolic syndrome (MetS) and insulin resistance remain to be determined. The present study aimed to assess the effects of recommendations to follow the DASH diet v. usual dietary advice (UDA) on the MetS and its features in adolescents. In this randomised cross-over clinical trial, sixty post-pubescent adolescent girls with the MetS were randomly assigned to receive either the recommendations to follow the DASH diet or UDA for 6 weeks. After a 4-week washout period, the participants were crossed over to the alternate arm. The DASH group was recommended to consume a diet rich in fruits, vegetables and low-fat dairy products and low in saturated fats, total fats and cholesterol. UDA consisted of general oral advice and written information about healthy food choices based on healthy MyPlate. Compliance was assessed through the quantification of plasma vitamin C levels. In both the groups, fasting venous blood samples were obtained at baseline and at the end of each phase of the intervention. The mean age and weight of the participants were 14.2 (SD 1.7) years and 69 (SD 14.5) kg, respectively. Their mean BMI and waist circumference were 27.3 kg/m2 and 85.6 cm, respectively. Serum vitamin C levels tended to be higher in the DASH phase than in the UDA phase (860 (SE 104) v. 663 (SE 76) ng/l, respectively, P= 0.06). Changes in weight, waist circumference and BMI were not significantly different between the two intervention phases. Although changes in systolic blood pressure were not statistically significant between the two groups (P= 0.13), recommendations to follow the DASH diet prevented the increase in diastolic blood pressure compared with UDA (P= 0.01). We found a significant within-group decrease in serum insulin levels (101.4 (SE 6.2) v. 90.0 (SE 5.5) pmol/l, respectively, P= 0.04) and a non-significant reduction in the homeostasis model assessment for insulin resistance

  7. Non-soya legume-based therapeutic lifestyle change diet reduces inflammatory status in diabetic patients: a randomised cross-over clinical trial.

    Science.gov (United States)

    Hosseinpour-Niazi, Somayeh; Mirmiran, Parvin; Fallah-Ghohroudi, Arefeh; Azizi, Fereidoun

    2015-07-01

    The present randomised cross-over clinical trial investigated the effects of two intervention diets (non-soya legume-based therapeutic lifestyle change (TLC) diet v. isoenergetic legume-free TLC diet) on inflammatory biomarkers among type 2 diabetic patients. A group of thirty-one participants (twenty-four women and seven men; weight 74.5 (SD 7.0) kg; age 58.1 (SD 6.0) years) were randomly assigned to one of the two following intervention diets for 8 weeks: legume-free TLC diet or non-soya legume-based TLC diet. The latter diet was the same as the legume-free TLC diet, except that two servings of red meat were replaced with different types of cooked non-soya legumes such as lentils, chickpeas, peas and beans over a period of 3 d per week. The intervention period was followed by a washout period of 4 weeks, after which the groups followed the alternate treatment for 8 weeks. Concentrations of inflammatory markers were measured at baseline and after the intervention periods. Compared with the legume-free TLC diet, the non-soya legume-based TLC diet significantly decreased high-sensitivity C-reactive protein, IL-6 and TNF-α in overweight diabetic patients. The replacement of two servings of red meat by non-soya legumes in the isoenergetic TLC diet for a period of 3 d per week reduced the plasma concentrations of inflammatory markers among overweight diabetic patients, independent of weight change.

  8. Oral health-related quality of life in patients with non-metal clasp dentures: a randomised cross-over trial.

    Science.gov (United States)

    Fueki, K; Yoshida-Kohno, E; Wakabayashi, N

    2017-05-01

    We investigated the efficacy of non-metal clasp dentures (NMCDs) with regard to the oral health-related quality of life (OHRQoL) and compare the findings with those for conventional metal clasp-retained dentures (MCDs). This single-centre, randomised controlled, two-phase, open label, cross-over trial included 28 partially dentate individuals. The patients were randomised to receive MCDs followed by NMCDs, or the opposite sequence (n = 14 in each group); each denture was worn for 3 months. OHRQoL was evaluated using the Oral Health Impact Profile-Japanese version (OHIP-J) at entry (T-entry; before treatment with the first denture) and at 3 months after treatment with each denture (T3). An examiner evaluated denture stability, oral appearance and surface roughness before denture delivery (T0) and at T3 and denture hygiene at T3. A total of 24 patients completed the trial. There were no complications related to the dentures, abutment teeth or denture-bearing mucosa during the follow-up periods for both dentures. The mean OHIP summary score was lower for NMCDs than for MCDs, and the difference (9 points) was greater than the minimal important difference (6 points), indicating the difference was clinically relevant. The effect size was medium (0·70). Statistical analyses with linear mixed models found a significant effect of the denture type on the OHIP summary score and scores for the Oro-facial appearance, Oro-facial pain and Psychological impact domains (NMCD < MCD; P < 0·05). The results of our study suggest that NMCDs allow for better OHRQoL compared with MCDs. © 2017 John Wiley & Sons Ltd.

  9. A randomised cross-over trial in healthy adults indicating improved absorption of omega-3 fatty acids by pre-emulsification

    Directory of Open Access Journals (Sweden)

    Tang James

    2007-01-01

    Full Text Available Abstract Background The health benefits of increased intakes of omega-3 fatty acids are well established but palatability often presents a problem. The process of emulsification is used in the food industry to provide a wider spectrum of use, often with the result of increased consumption. Moreover, as emulsification is an important step in the digestion and absorption of fats, the pre-emulsification process may enhance digestion and absorption. In this study the levels of plasma fatty acid and triacylglycerol (TAG following the ingestion of either an oil mixture or an emulsified oil mixture have been compared. Methods In this randomised cross-over study, 13 volunteers received the oil mixture and 11 received the oil emulsion as part of an otherwise fat free meal. Blood samples were collected at 0, 1.5, 3, 4.5, 6, 7.5 and 9 hours after ingestion of oil, separated and stored at -20°C. Plasma triacylglycerols were assessed spectrophotometrically and fatty acids were determined by gas chromatography. Following a washout period of twenty days the procedure was repeated with the assignments reversed. Results The postprandial plasma TAG and the C18:3 (n-6, C18:3(n-3, C20:5(n-3 and C22:6 (n-3 polyunsaturated fatty acid (PUFA levels for the emulsified oil group were increased significantly (P = 0.0182; P = 0.0493; P = 0.0137; P Conclusion Pre-emulsification of an oil mixture prior to ingestion increases the absorption of longer chain more highly unsaturated fatty acids (especially eicosapentaenoic acid and docosahexaenoic acid but does not affect absorption of shorter chain less saturated fatty acids, suggesting that pre-emulsification of fish oils may be a useful means of boosting absorption of these beneficial fatty acids. Trial registration: Current Controlled Trials ISRCTN43202606

  10. Marked antioxidant effect of orange juice intake and its phytomicronutrients in a preliminary randomized cross-over trial on mild hypercholesterolemic men.

    Science.gov (United States)

    Constans, Joël; Bennetau-Pelissero, Catherine; Martin, Jean-François; Rock, Edmond; Mazur, Andrzej; Bedel, Aurélie; Morand, Christine; Bérard, Annie M

    2015-12-01

    Blond orange juice is the most consumed fruit juice in the world. It is a source of hesperidin, a bioavailable flavonoid reported to exhibit potential vascular protective actions. However, the specific impact on vascular function of Citrus phytomicronutrients, is unknown. For the first time, we investigated the effects of blond orange juice compared with a control beverage mimicking the composition of orange juice (including Vitamin C but no phytomicronutrients), on antioxidant markers, cardiovascular risk factors and endothelial function. Twenty five male volunteers with two cardiovascular risk factors (age over 50 years and LDL-cholesterol between 130 and 190 mg/L) were enrolled in a randomized cross-over study. They received 3 times daily 200 mL of either blond orange juice or control beverage for 4 weeks, spaced by a 5-week wash-out. Endothelial function (flow mediated dilatation and plasma markers), oxidative status, lipid profile and inflammatory markers were assessed. Daily intakes of orange juice significantly led to a marked antioxidant effect which was correlated to hesperetin plasma levels and related with a decrease in reactive oxygen species. A tendency towards reduction of endothelial dysfunction and modest increase in plasma apoA-I concentration were also observed. This allows further experiments demonstrating the specific effect of phytomicronutrients from orange juice. These findings suggest that daily intake of nutritionally relevant dose of blond orange juice may contribute for a significant antioxidant effect through the phytochemicals contained in. Orange juice may be associated to other healthy foods to achieve a significant effect on the vascular function. This study is recorded in ClinicalTrials.com as NCT00539916. Copyright © 2014. Published by Elsevier Ltd.

  11. Use of the learning conversation improves instructor confidence in life support training: An open randomised controlled cross-over trial comparing teaching feedback mechanisms.

    Science.gov (United States)

    Baldwin, Lydia J L; Jones, Christopher M; Hulme, Jonathan; Owen, Andrew

    2015-11-01

    Feedback is vital for the effective delivery of skills-based education. We sought to compare the sandwich technique and learning conversation structured methods of feedback delivery in competency-based basic life support (BLS) training. Open randomised crossover study undertaken between October 2014 and March 2015 at the University of Birmingham, United Kingdom. Six-hundred and forty healthcare students undertaking a European Resuscitation Council (ERC) BLS course were enrolled, each of whom was randomised to receive teaching using either the sandwich technique or the learning conversation. Fifty-eight instructors were randomised to initially teach using either the learning conversation or sandwich technique, prior to crossing-over and teaching with the alternative technique after a pre-defined time period. Outcome measures included skill acquisition as measured by an end-of-course competency assessment, instructors' perception of teaching with each feedback technique and candidates' perception of the feedback they were provided with. Scores assigned to use of the learning conversation by instructors were significantly more favourable than for the sandwich technique across all but two assessed domains relating to instructor perception of the feedback technique, including all skills-based domains. No difference was seen in either assessment pass rates (80.9% sandwich technique vs. 77.2% learning conversation; OR 1.2, 95% CI 0.85-1.84; p=0.29) or any domain relating to candidates' perception of their teaching technique. This is the first direct comparison of two feedback techniques in clinical medical education using both quantitative and qualitative methodology. The learning conversation is preferred by instructors providing competency-based life support training and is perceived to favour skills acquisition. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  12. Teaching Evidence-Based Complementary and Alternative Medicine (EBCAM; Changing behaviours in the face of reticence: A cross-over trial

    Directory of Open Access Journals (Sweden)

    Saranchuk Ron

    2002-01-01

    Full Text Available Abstract Background The effectiveness of teaching critical appraisal to students of Complementary and Alternative Medicine (CAM has not been studied. In this study we attempt to determine if a workshop for final year students at a naturopathic college improved their ability to utilize critical appraisal concepts. Methods We assigned 83 Naturopathic Interns to two groups: Group A (n = 47 or Group B (n = 36. We conducted a baseline assessment of all subjects' critical appraisal skills. Group A was assigned to receive a 3 ½ hour workshop on Evidence Based Medicine (EBM and Group B received a workshop on bioethics (control intervention. The groups critical appraisal skills were re-evaluated at this time. We then crossed over the intervention so that Group B received the EBM workshop while Group A received the bioethics workshop. Assessment of critical appraisal skills of the two groups was again performed. Results The students mean scores were similar in Group A (14.8 and Group B (15.0 after Group A had received the intervention and Group B had received the control (p = 0.75. Group scores were not significantly improved at the end of the trial compared to at the beginning of the study (Group A: 15.1 to 16.1 (Group B 15.6 to 15.9. Student's confidence in reading research papers also did not improve throughout the course of the study. Conclusion The final year is a difficult but important time to teach critical appraisal and evidence skills. Single, short intervention programs will likely yield negligible results. A multi-factorial approach may be better suited to implementing EBCAM than single short interventions.

  13. Does a single bout of resistance or aerobic exercise after insulin dose reduction modulate glycaemic control in type 2 diabetes? A randomised cross-over trial.

    Science.gov (United States)

    Gordon, Brett A; Bird, Stephen R; MacIsaac, Richard J; Benson, Amanda C

    2016-10-01

    Regular exercise is advocated for individuals with type 2 diabetes, without fully understanding the acute (0-72h post-exercise) glycaemic response. This study assessed post-exercise glycaemic profiles of non-exercising individuals with insulin treated type 2 diabetes, following resistance and aerobic exercise. Randomised cross-over trial. Fourteen individuals with insulin treated type 2 diabetes (9 males, 5 females) aged 58.1±7.1 years (HbA1c: 8.0±0.6%) were allocated to single sessions of resistance (six whole-body exercises, three sets, 8-10 repetitions, 70% 1RM) and aerobic (30min cycling, 60% VO2peak) exercise, 7-days apart, with the day prior to the first exercise day of each intervention being the control condition. Immediately prior to exercise, insulin dosage was halved and breakfast consumed. Continuous glucose monitoring was undertaken to determine area under the curve and glucose excursions. Blood glucose initially increased (0-2h) following both resistance and aerobic exercise (paerobic (211±40 mmolL(-1)24h(-1)) exercise (p=0.56). Incidence of hyperglycaemia did not differ between exercise modes (p=0.68). Hypoglycaemic events were identified in three and four participants following resistance and aerobic exercise respectively: these did not require treatment. Glycaemic response is not different between exercise modes, although 50% insulin dose reduction prior to exercise impairs the expected improvement. A common clinical recommendation of 50% insulin dose reduction does not appear to cause adverse glycaemic events. Copyright © 2016 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  14. Combining gender, work, and family identities: The cross-over and spill-over of gender norms into young adults’ work and family aspirations

    Directory of Open Access Journals (Sweden)

    Loes Meeussen

    2016-11-01

    Full Text Available The current study investigates how descriptive and prescriptive gender norms that communicate work and family identities to be (incompatible with gender identities limit or enhance young men and women’s family and career aspirations. Results show that young adults (N=445 perceived gender norms to assign greater compatibility between female and family identities and male and work identities than vice versa, and that young men and women mirror their aspirations to this traditional division of tasks. Spill-over effects of norms across life domains and cross-over effects of norms across gender-groups indicated that young women, more than young men, aimed to ‘have it all’: mirroring their career ambitions to a male career model, while keeping their family aspirations high. Moreover, young women opposed traditional role divisions in the family domain by decreasing their family aspirations in face of norms of lower family involvement or higher career involvement of men. Conversely, in line with traditional gender roles, young men showed lower family aspirations in the face of strong male career norms; and showed increases in their career aspirations when perceiving women to take up more family roles. Young men’s family aspirations were, however, more influenced by new norms prescribing men to invest more in their family, suggesting opportunities for change. Together, these findings show that through social norms, young adults’ gender identity affects aspirations for how to manage the co-presence of their work and family identities. Altering these norms may provide leverage for change to allow both men and women to combine their multiple identities in an enriching way.

  15. Assessing the contact-activation of coagulation during hemodialysis with three different polysulfone filters: A prospective randomized cross-over trial.

    Science.gov (United States)

    Salvadè, Igor; Del Giorno, Rosaria; Gaetano, Donato; Gabutti, Luca

    2017-07-01

    During hemodialysis (HD) the interaction of the blood with the dialyzer triggers both an inflammatory reaction and an activation of the coagulation cascade. An accepted parameter to quantify the extent of coagulation activation during HD is not available. This study aims to evaluate its amplitude, comparing dialyzers made of different polysulfone polymers, by measuring D-dimers in the filter-rinsing fluids (Frf) and to test whether Frf D-dimers are suitable candidate markers to assess contact coagulation activation during HD. In a prospective, cross-over study 41 hemodialysis patients were randomly allocated to nine HD sessions with three types of polysulfone membranes: Filter A: Poliflux®RevaclearMAX; Filter B: Helixone®Fx80, Filter C: Polyflux®H210. A total of 117 HD sessions were studied. The mean (SD) filter (Frf) D-dimers were 0.19 µg/L (0.56) for Filter A; 0.66 µg/L (2.81) for Filter B; 0.33 µg/L (1.13) for Filter C. Significant differences were found: A vs. B (P filter levels was found. D-Dimers in blood showed a similar trend but differences were not significant. The contact activation of coagulation during HD may also vary among filters made up with similar polysulfones. D-dimer in the filter rinsing fluid but not in the blood can be considered a candidate marker for the evaluation of thrombogenicity during HD. Further studies are needed to elucidate the mechanism(s) and to confirm the usefulness of filter rinsing fluid D-Dimers as a clotting activation marker during HD. © 2016 International Society for Hemodialysis.

  16. Impact of Denture Cleaning Method and Overnight Storage Condition on Denture Biofilm Mass and Composition: A Cross-Over Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Joke Duyck

    Full Text Available Appropriate oral hygiene is required to maintain oral health in denture wearers. This study aims to compare the role of denture cleaning methods in combination with overnight storage conditions on biofilm mass and composition on acrylic removable dentures.In a cross-over randomized controlled trial in 13 older people, 4 conditions with 2 different mechanical cleaning methods and 2 overnight storage conditions were considered: (i brushing and immersion in water without a cleansing tablet, (ii brushing and immersion in water with a cleansing tablet, (iii ultrasonic cleaning and immersion in water without a cleansing tablet, and (iv ultrasonic cleaning and immersion in water with a cleansing tablet. Each test condition was performed for 5 consecutive days, preceded by a 2-days wash-out period. Biofilm samples were taken at baseline (control and at the end of each test period from a standardized region. Total and individual levels of selected oral bacteria (n = 20, and of Candida albicans were identified using the Polymerase Chain Reaction (PCR technique. Denture biofilm coverage was scored using an analogue denture plaque score. Paired t-tests and Wilcoxon-signed rank tests were used to compare the test conditions. The level of significance was set at α< 5%.Overnight denture storage in water with a cleansing tablet significantly reduced the total bacterial count (p<0.01. The difference in total bacterial level between the two mechanical cleaning methods was not statistically significant. No significant effect was observed on the amount of Candida albicans nor on the analogue plaque scores.The use of cleansing tablets during overnight denture storage in addition to mechanical denture cleaning did not affect Candida albicans count, but reduced the total bacterial count on acrylic removable dentures compared to overnight storage in water. This effect was more pronounced when combined with ultrasonic cleaning compared to brushing

  17. Combining Gender, Work, and Family Identities: The Cross-Over and Spill-Over of Gender Norms into Young Adults' Work and Family Aspirations.

    Science.gov (United States)

    Meeussen, Loes; Veldman, Jenny; Van Laar, Colette

    2016-01-01

    The current study investigates how descriptive and prescriptive gender norms that communicate work and family identities to be (in)compatible with gender identities limit or enhance young men and women's family and career aspirations. Results show that young adults ( N = 445) perceived gender norms to assign greater compatibility between female and family identities and male and work identities than vice versa, and that young men and women mirror their aspirations to this traditional division of tasks. Spill-over effects of norms across life domains and cross-over effects of norms across gender-groups indicated that young women, more than young men, aimed to 'have it all': mirroring their career ambitions to a male career model, while keeping their family aspirations high. Moreover, young women opposed traditional role divisions in the family domain by decreasing their family aspirations in face of norms of lower family involvement or higher career involvement of men. Conversely, in line with traditional gender roles, young men showed lower family aspirations in the face of strong male career norms; and showed increases in their career aspirations when perceiving women to take up more family roles. Young men's family aspirations were, however, more influenced by new norms prescribing men to invest more in their family, suggesting opportunities for change. Together, these findings show that through social norms, young adults' gender identity affects aspirations for how to manage the co-presence of their work and family identities. Altering these norms may provide leverage for change to allow both men and women to combine their multiple identities in an enriching way.

  18. Combining Gender, Work, and Family Identities: The Cross-Over and Spill-Over of Gender Norms into Young Adults’ Work and Family Aspirations

    Science.gov (United States)

    Meeussen, Loes; Veldman, Jenny; Van Laar, Colette

    2016-01-01

    The current study investigates how descriptive and prescriptive gender norms that communicate work and family identities to be (in)compatible with gender identities limit or enhance young men and women’s family and career aspirations. Results show that young adults (N = 445) perceived gender norms to assign greater compatibility between female and family identities and male and work identities than vice versa, and that young men and women mirror their aspirations to this traditional division of tasks. Spill-over effects of norms across life domains and cross-over effects of norms across gender-groups indicated that young women, more than young men, aimed to ‘have it all’: mirroring their career ambitions to a male career model, while keeping their family aspirations high. Moreover, young women opposed traditional role divisions in the family domain by decreasing their family aspirations in face of norms of lower family involvement or higher career involvement of men. Conversely, in line with traditional gender roles, young men showed lower family aspirations in the face of strong male career norms; and showed increases in their career aspirations when perceiving women to take up more family roles. Young men’s family aspirations were, however, more influenced by new norms prescribing men to invest more in their family, suggesting opportunities for change. Together, these findings show that through social norms, young adults’ gender identity affects aspirations for how to manage the co-presence of their work and family identities. Altering these norms may provide leverage for change to allow both men and women to combine their multiple identities in an enriching way. PMID:27909416

  19. Young Women's Ratings of Three Placebo Multipurpose Prevention Technologies for HIV and Pregnancy Prevention in a Randomized, Cross-Over Study in Kenya and South Africa.

    Science.gov (United States)

    Minnis, Alexandra M; Roberts, Sarah T; Agot, Kawango; Weinrib, Rachel; Ahmed, Khatija; Manenzhe, Kgahlisho; Owino, Fredrick; van der Straten, Ariane

    2018-03-20

    End-user input is critical to inform development of multipurpose prevention technology (MPT) products that prevent HIV and pregnancy. The TRIO Study, conducted in Kenya and South Africa, enrolled 277 HIV-negative women aged 18-30 in a randomized cross-over study to use each placebo MPT (daily oral tablets, monthly injections, and monthly vaginal ring) for one month. At the end of each month, participants rated how much they liked using the product on a 5-point Likert scale (5 = liked very much). We compared mean ratings using paired t-tests and examined sociodemographic-, attribute-, and behavior-related characteristics associated with ratings using multivariable linear regression and data from in-depth interviews. After use, mean ratings were significantly higher for injections [4.3 (SD = 1.0)] compared with tablets [3.0 (SD = 1.3)] and rings [3.3 (SD = 1.4)] (p < 0.001); mean ratings for rings were significantly higher than for tablets (p = 0.013). Mean ratings of a hypothetical active MPT increased for all products after the one-month period of use, with the greatest increase for rings, the least familiar product. In multivariable analysis, acceptability of key product attributes (e.g., product look) were associated with a significant increase of ≥ 1 point in the mean rating across all three products (p ≤ 0.001). Perceived ability to use the product without partner knowledge was associated with a higher mean rating for rings (b = 0.50; p = 0.006). The acceptability of product attributes contributed significantly to the rating of all products, highlighting the value of choice in pregnancy and HIV prevention to accommodate diverse users.

  20. Take a walk in the park? A cross-over pilot trial comparing brisk walking in two different environments: park and urban.

    Science.gov (United States)

    Sellers, C E; Grant, P M; Ryan, C G; O'Kane, C; Raw, K; Conn, D

    2012-11-01

    The objective of the present study is to investigate whether differences exist between a 30 minute brisk walk taken in two different environments in order to determine which environment best facilitates current physical activity guidelines: park or urban. In this randomised cross-over pilot study, participants performed a self-timed 30 minute brisk walk in two different environments, park and urban, in Glasgow, Scotland (October 2009 to January 2010). Cadence, recorded using the activPAL™ activity monitor, was used to measure intensity. Outcome measures were: mean cadence; moderate-to-vigorous physical activity time accumulated in bouts lasting ≥ 10 min; number of walking breaks; and duration. A convenience sample of 40 healthy adults was recruited: 16 males, 24 females, mean age 22.9 (5.5) years. The mean cadence for the whole walk was higher in the park: 119.3 (8.3) vs. 110.9 (8.9) steps/min. Participants accumulated more moderate-to-vigorous physical activity in ≥ 10 minute bouts during park walks: 25.5 (9.6) [median (interquartile range)] vs. 14.0 (20.3) min. There was no difference in self-timed duration between locations. Participants accumulated more moderate-to-vigorous physical activity in bouts ≥ 10 min in duration on park walks due to the lack of interruptions in walking. Hence the park environment better facilitated the achievement of current physical activity guidelines. Further research involving a larger, more heterogeneous sample is recommended. Copyright © 2012 Elsevier Inc. All rights reserved.

  1. Kinematic analysis of the powerlifting style squat and the conventional deadlift during competition: is there a cross-over effect between lifts?

    Science.gov (United States)

    Hales, Michael E; Johnson, Benjamin F; Johnson, Jeff T

    2009-12-01

    Many individuals involved in the sport of powerlifting believe that the squat and deadlift have such similar lifting characteristics that the lifts yield comparable training results. The aim of this study was to compare and contrast biomechanical parameters between the conventional style deadlift and the back squat performed by 25 lifters competing in regional powerlifting championship. The 3-dimensional analysis incorporated 4 60 Hz synchronized video cameras for collecting data from 25 participants. Parameters were quantified at the sticking point specific to each lift. Kinematic variables were calculated at the hip, knee, and ankle. Paired (samples) t-tests were used to detect significant differences in the kinematic mean scores for the different lift types. The statistical analysis revealed significant differences exist between the squat (0.09 m/s) and the deadlift (0.20 m/s) vertical bar velocities. Differences were found for angular position of the hip, knee, and ankle between lifts. The sticking point thigh angles were quantified as 32.54 +/- 3.02 and 57.42 +/- 4.57 for the squat and deadlift, respectively. Trunk angles were 40.58 +/- 6.29 (squat) and 58.30 +/- 7.15 (deadlift). The results indicate the back squat represents a synergistic or simultaneous movement, whereas the deadlift demonstrates a sequential or segmented movement. The kinematic analysis of the squat and the conventional deadlift indicate that the individual lifts are markedly different (p < 0.01), implying that no direct or specific cross-over effect exists between the individual lifts.

  2. Homer: The Blind Bard

    Science.gov (United States)

    Doorley, Rachelle; King, Judith

    2005-01-01

    This article describes notable cultural, historical, and artistic elements emanating from sculptures originating in ancient Greece. The "blind bard" and its connection to the legendary Greek poet, Homer; Homer's impact on literary history; trends among Roman sculptures; and Roman replication of Greek art are described. Questions to…

  3. Design, conduct, and analyses of Breast International Group (BIG) 1-98: a randomized, double-blind, phase-III study comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with receptor-positive, early breast cancer.

    Science.gov (United States)

    Giobbie-Hurder, Anita; Price, Karen N; Gelber, Richard D

    2009-06-01

    Aromatase inhibitors provide superior disease control when compared with tamoxifen as adjuvant therapy for postmenopausal women with endocrine-responsive early breast cancer. To present the design, history, and analytic challenges of the Breast International Group (BIG) 1-98 trial: an international, multicenter, randomized, double-blind, phase-III study comparing the aromatase inhibitor letrozole with tamoxifen in this clinical setting. From 1998-2003, BIG 1-98 enrolled 8028 women to receive monotherapy with either tamoxifen or letrozole for 5 years, or sequential therapy of 2 years of one agent followed by 3 years of the other. Randomization to one of four treatment groups permitted two complementary analyses to be conducted several years apart. The first, reported in 2005, provided a head-to-head comparison of letrozole versus tamoxifen. Statistical power was increased by an enriched design, which included patients who were assigned sequential treatments until the time of the treatment switch. The second, reported in late 2008, used a conditional landmark approach to test the hypothesis that switching endocrine agents at approximately 2 years from randomization for patients who are disease-free is superior to continuing with the original agent. The 2005 analysis showed the superiority of letrozole compared with tamoxifen. The patients who were assigned tamoxifen alone were unblinded and offered the opportunity to switch to letrozole. Results from other trials increased the clinical relevance about whether or not to start treatment with letrozole or tamoxifen, and analysis plans were expanded to evaluate sequential versus single-agent strategies from randomization. Due to the unblinding of patients assigned tamoxifen alone, analysis of updated data will require ascertainment of the influence of selective crossover from tamoxifen to letrozole. BIG 1-98 is an example of an enriched design, involving complementary analyses addressing different questions several years

  4. Postural control in blind subjects.

    Science.gov (United States)

    Soares, Antonio Vinicius; Oliveira, Cláudia Silva Remor de; Knabben, Rodrigo José; Domenech, Susana Cristina; Borges Junior, Noe Gomes

    2011-12-01

    To analyze postural control in acquired and congenitally blind adults. A total of 40 visually impaired adults participated in the research, divided into 2 groups, 20 with acquired blindness and 20 with congenital blindness - 21 males and 19 females, mean age 35.8 ± 10.8. The Brazilian version of Berg Balance Scale and the motor domain of functional independence measure were utilized. On Berg Balance Scale the mean for acquired blindness was 54.0 ± 2.4 and 54.4 ± 2.5 for congenitally blind subjects; on functional independence measure the mean for acquired blind group was 87.1 ± 4.8 and 87.3 ± 2.3 for congenitally blind group. Based upon the scale used the results suggest the ability to control posture can be developed by compensatory mechanisms and it is not affected by visual loss in congenitally and acquired blindness.

  5. PHYSICAL DEVELOPMENT OF BLIND CHILDREN

    OpenAIRE

    Mira CVETKOVA

    1998-01-01

    A review is made on the research and studies concerning physical and motor development of blind children. An emphasis is also put on development of hand movements as part of the whole motor development process of the blind.

  6. Postural control in blind subjects

    Directory of Open Access Journals (Sweden)

    Antonio Vinicius Soares

    2011-12-01

    Full Text Available Objective: To analyze postural control in acquired and congenitally blind adults. Methods: A total of 40 visually impaired adults participated in the research, divided into 2 groups, 20 with acquired blindness and 20 with congenital blindness - 21 males and 19 females, mean age 35.8 ± 10.8. The Brazilian version of Berg Balance Scale and the motor domain of functional independence measure were utilized. Results: On Berg Balance Scale the mean for acquired blindness was 54.0 ± 2.4 and 54.4 ± 2.5 for congenitally blind subjects; on functional independence measure the mean for acquired blind group was 87.1 ± 4.8 and 87.3 ± 2.3 for congenitally blind group. Conclusion: Based upon the scale used the results suggest the ability to control posture can be developed by compensatory mechanisms and it is not affected by visual loss in congenitally and acquired blindness.

  7. User-centered Technologies For Blind Children

    OpenAIRE

    Jaime Sánchez

    2008-01-01

    The purpose of this paper is to review, summarize, and illustrate research work involving four audio-based games created within a user-centered design methodology through successive usability tasks and evaluations. These games were designed by considering the mental model of blind children and their styles of interaction to perceive and process data and information. The goal of these games was to enhance the cognitive development of spatial structures, memory, haptic perception, mathe...

  8. Effect of pulsed electromagnetic field therapy on experimental pain: A double-blind, randomized study in healthy young adults.

    Science.gov (United States)

    Beaulieu, Karen; Beland, Patricia; Pinard, Marilee; Handfield, Guilène; Handfield, Nicole; Goffaux, Philippe; Corriveau, Hélène; Léonard, Guillaume

    2016-01-01

    Previous studies suggested that pulsed electromagnetic field (PEMF) therapy can decrease pain. To date, however, it remains difficult to determine whether the analgesic effect observed in patients are attributable to a direct effect of PEMF on pain or to an indirect effect of PEMF on inflammation and healing. In the present study, we used an experimental pain paradigm to evaluate the direct effect of PEMF on pain intensity, pain unpleasantness, and temporal summation of pain. Twenty-four healthy subjects (mean age 22 ± 2 years; 9 males) participated in the experiment. Both real and sham PEMF were administered to every participant using a randomized, double-blind, cross-over design. For each visit, PEMF was applied for 10 minutes on the right forearm using a portable device. Experimental pain was evoked before (baseline) and after PEMF with a 9 cm(2) Pelletier-type thermode, applied on the right forearm (120 s stimulation; temperature individually adjusted to produce moderate baseline pain). Pain intensity and unpleasantness were evaluated using a 0-100 numerical pain rating scale. Temporal summation was evaluated by comparing pain intensity ratings obtained at the end of tonic nociceptive stimulation (120 s) with pain intensity ratings obtained after 60 s of stimulation. When compared to baseline, there was no change in pain intensity and unpleasantness following the application of real or sham PEMF. PEMF did not affect temporal summation. The present observations suggest that PEMF does not directly influence heat pain perception in healthy individuals.

  9. A Smart Infrared Microcontroller-Based Blind Guidance System

    Directory of Open Access Journals (Sweden)

    Amjed S. Al-Fahoum

    2013-01-01

    Full Text Available Blindness is a state of lacking the visual perception due to physiological or neurological factors. The partial blindness represents the lack of integration in the growth of the optic nerve or visual centre of the eye, and total blindness is the full absence of the visual light perception. In this work, a simple, cheap, friendly user, smart blind guidance system is designed and implemented to improve the mobility of both blind and visually impaired people in a specific area. The proposed work includes a wearable equipment consists of head hat and mini hand stick to help the blind person to navigate alone safely and to avoid any obstacles that may be encountered, whether fixed or mobile, to prevent any possible accident. The main component of this system is the infrared sensor which is used to scan a predetermined area around blind by emitting-reflecting waves. The reflected signals received from the barrier objects are used as inputs to PIC microcontroller. The microcontroller is then used to determine the direction and distance of the objects around the blind. It also controls the peripheral components that alert the user about obstacle's shape, material, and direction. The implemented system is cheap, fast, and easy to use and an innovative affordable solution to blind and visually impaired people in third world countries.

  10. Effect of supplementation with B vitamins and antioxidants on levels of asymmetric dimethylarginine (ADMA) and C-reactive protein (CRP): a double-blind, randomised, factorial design, placebo-controlled trial.

    Science.gov (United States)

    O'Doherty, Mark G; Gilchrist, Sarah E C M; Young, Ian S; McKinley, Michelle C; Yarnell, John W G; Gey, K Fred; Evans, Alun; Skidmore, Paula M L; Woodside, Jayne V

    2010-12-01

    Cardiovascular risk factors such as elevated levels of asymmetric dimethylarginine (ADMA)/C-reactive protein (CRP) and homocysteine are potentially related to essential micronutrients such as certain B vitamins and antioxidant vitamins. The aim of the present study was to investigate whether supplementation with moderate doses of B vitamins and/or antioxidants could alter either ADMA and/or CRP concentrations in middle-aged, apparently healthy men with mildly elevated homocysteine levels. A randomised, double-blind, factorial design, intervention study was carried out on 132 men with mildly elevated homocysteine levels, allocated to four groups (a) B vitamins alone--1 mg folic acid, 7.2 mg pyridoxine, 0.02 mg cyanocobalamin daily, (b) antioxidants alone--150 mg ascorbic acid, 67 mg vitamin E, 9 mg β-carotene daily, (c) B vitamins with antioxidant vitamins, or (d) placebo. A total of 101 men completed the study to 8 weeks. When the percentage of baseline ADMA and CRP was examined at 8 weeks, no statistically significant differences were observed between the four groups (p = 0.21 and p = 0.90, respectively). Similar non-significant results were observed when analysis was stratified based on baseline CRP levels (B vitamins and/or antioxidants did not alter either ADMA or CRP concentrations in these middle-aged, apparently healthy men with mildly elevated homocysteine levels.

  11. The willed blindness of humans

    DEFF Research Database (Denmark)

    Gjerris, Mickey

    2012-01-01

    This paper describes how we seem to live in a willed blindness towards the effects that our meat production and consumption have on animals, the environment and the climate. It is a willed blindness that cannot be explained by either lack of knowledge or scientific uncertainty. The blindness enab...

  12. A randomized, placebo-controlled, double-blind study to confirm the reversal of hepatorenal syndrome type 1 with terlipressin: the REVERSE trial design

    Directory of Open Access Journals (Sweden)

    Boyer TD

    2012-07-01

    Full Text Available Thomas D Boyer,1 Joseph J Medicis,2 Stephen Chris Pappas,3 Jim Potenziano,2 Khuramm Jamil21Department of Medicine, University of Arizona College of Medicine, Tucson, AZ, USA; 2Research and Development, Ikaria, Hampton, NJ, USA; 3Orphan Therapeutics, Lebanon, NJ, USABackground: Hepatorenal syndrome (HRS is a rare disorder of marked renal dysfunction in patients with cirrhosis, ascites, and portal hypertension. Type 1 HRS is a rapidly progressive acute kidney injury that develops shortly after a precipitating event, followed by a deterioration of function of other organs (eg, heart, brain, liver, adrenal glands. Presently, no approved drug therapies exist for HRS type 1 in the USA, Canada, or Australia. Given the rarity of this condition and the existing unmet medical need for treatment, the US Food and Drug Administration granted orphan drug and fast-track designations for terlipressin. The objective of the REVERSE trial was to determine the efficacy and safety of intravenous terlipressin compared with placebo in the treatment of adults with HRS type 1 who were also receiving intravenous albumin.Methods: 180 subjects with HRS type 1 were enrolled at 65 investigational sites located in the USA and ten sites in Canada. Patients were randomized in a 1:1 ratio to treatment with either intravenous terlipressin administered every 6 hours or placebo for up to 14 days. The primary efficacy measure was confirmed HRS reversal, defined as the percentage of patients with two serum creatinine values of ≤1.5 mg/dL at least 48 hours apart, on treatment, and without intervening renal replacement therapy or liver transplantation. Other efficacy measures included change in renal function as reflected in serum creatinine levels, fractional excretion of sodium, recurrence of HRS type 1, transplant-free, dialysis-free, and overall survival.Discussion: Data from this pivotal study are intended to demonstrate whether terlipressin is effective in reversing HRS type 1

  13. The effectiveness of healthy meals at work on reaction time, mood and dietary intake: a randomised cross-over study in daytime and shift workers at an university hospital.

    Science.gov (United States)

    Leedo, Eva; Beck, Anne Marie; Astrup, Arne; Lassen, Anne D

    2017-07-01

    Our dietary habits affect both cognitive performance and mood. The aim of the study was to examine the effect of increased availability of healthy meals and water at work on healthcare staff. The study used an 8-week randomised cross-over design. A total of sixty physicians, nurses and nursing assistants, including sixteen working on shifts, were recruited. The participants received a self-selected keyhole-labelled (Nordic nutrition label) lunch, snack and bottled water during each shift throughout the intervention period. Reaction time (Go/No-Go test), mood-related scores (POMS) and dietary intake were assessed at run-in, and at the end of the intervention and the control periods. The intake of fat (P=0·030) and PUFA (P=0·003) was lower, and the intake of carbohydrate (P=0·008), dietary fibre (P=0·031) and water (Pmood-related scores in the group as a whole. In shift-working participants, the intervention period resulted in a 31·1 % lower Fatigue-Inertia Score (P=0·003), a 15·3 % higher Vigour-Activity Score (P=0·041) and a 42·7 % lower Total Mood Disturbance Score (P=0·017), whereas the only dietary component that significantly improved was water intake (P=0·034), when compared with the control period. Providing healthy meals, snacks and water during working hours seems to be an effective way of improving employees' dietary intake. Moreover, increased intake of water may be associated with beneficial effects on fatigue, vigour and total mood in shift-working healthcare staff.

  14. Simvastatin decreases levodopa-induced dyskinesia in monkeys, but not in a randomized, placebo-controlled, multiple cross-over ("n-of-1") exploratory trial of simvastatin against levodopa-induced dyskinesia in Parkinson's disease patients.

    Science.gov (United States)

    Tison, François; Nègre-Pagès, Laurence; Meissner, Wassilios G; Dupouy, Sandrine; Li, Qin; Thiolat, Marie-Laure; Thiollier, Thibaud; Galitzky, Monique; Ory-Magne, Fabienne; Milhet, Agathe; Marquine, Laurent; Spampinato, Umberto; Rascol, Olivier; Bezard, Erwan

    2013-04-01

    Simvastatin may improve levodopa-induced dyskinesia through striatal Ras-extracellular signal-regulated kinase pathway modulation. (1) Six 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine-treated macaques were assessed for parkinsonism and dyskinesia severity following acute co-administration of levodopa and simvastatin (0, 1.5, 3 and 6 mg/kg). (2) A "n-of-1" design randomized, placebo-controlled, 3 cross-over trial was then conducted in 10 Parkinson's disease patients with troublesome dyskinesia. The primary endpoint was a 7-point scale rating subjective discomfort caused by troublesome dyskinesia. Secondary endpoints related to dyskinesia severity and duration and functional impairment, severity and duration of OFF periods, motor scores and investigator- and patient-rated global impressions. (3) The pharmacodynamic variable for both studies consisted in a multiplex analysis of kinase-induced phosphorylation in T and B-lymphocytes by flow cytometry. (1) In the macaque, simvastatin reduced dyskinesia scores (45%), at the dose of 3 mg/kg (2) In the "n-of-1" trial no significant response was observed in the primary end point and all secondary endpoints. No serious adverse events were reported. (3) Simvastatin 3 mg/kg significantly reduce kinase-induced phosphorylation in monkeys but not simvastatin 40 mg in patients. Simvastatin reduced dyskinesia in primates using high doses over 3 mg/kg but the exploratory trial in patients revealed no effect at 40 mg/d suggesting that higher doses, not compatible with a safe prolonged administration, are necessary. Copyright © 2012 Elsevier Ltd. All rights reserved.

  15. Differential effects of fenofibrate versus atorvastatin on the concentrations of E-selectin and vascular cellular adhesion molecule-1 in patients with type 2 diabetes mellitus and mixed hyperlipoproteinemia: a randomized cross-over trial

    Directory of Open Access Journals (Sweden)

    Otto Carsten

    2003-12-01

    Full Text Available Abstract Background Diabetic dyslipoproteinemia is characterized by hypertriglyceridemia, low HDL-cholesterol and often elevated LDL-cholesterol and is a strong risk factor for atherosclerosis. Adhesion molecule levels are elevated both in hyperlipoproteinemia and diabetes mellitus. It is unclear whether fibrate or statin therapy has more beneficial effects on adhesion molecule concentrations. Methods Atorvastatin (10 mg/d was compared to fenofibrate (200 mg/d each for 6 weeks separated by a 6 week washout period in 11 patients (6 male, 5 female; 61.8 ± 8.2 years; body mass index 29.8 ± 3.1 kg/m2 with type 2 diabetes mellitus (HbA1c 7.3 ± 1.1 % and mixed hyperlipoproteinemia using a randomized, cross-over design. Fasting blood glucose, HbA1c, lipid parameters, E-selectin, ICAM-1, VCAM-1, and fibrinogen concentrations were determined before and after each drug. Results Glucose and HbA1c concentrations remained unchanged during the whole study period. LDL cholesterol was reduced during atorvastatin therapy, triglycerides were lowered more effectively with fenofibrate. Comparison of pre- and postreatment concentrations of E-selectin showed a reduction during atorvastatin (-7 %, p = 0.11 and fenofibrate (-10 %, p Conclusions In addition to the different beneficial effects on lipid metabolism, both drugs appear to lower adhesion molecule plasma concentrations in a different manner in patients with type 2 diabetes and mixed hyperlipoproteinemia. Our observations should be confirmed in a larger cohort of such patients.

  16. Central Sensitization Is Modulated Following Trigger Point Anesthetization in Patients with Chronic Pain from Whiplash Trauma. A Double-Blind, Placebo-Controlled, Crossover Study.

    Science.gov (United States)

    Nystrom, N Ake; Freeman, Michael D

    2018-01-01

    Central sensitization (CS) with low peripheral pain thresholds (PPTs) is a common finding among patients with chronic pain after whiplash (CPWI). While it has been proposed that myofascial myofascial trigger points (MTrPs) may act as modulators of central sensitization, previously reported findings are conflicting and inconclusive. The present study was designed to investigate immediate responsiveness of CS to alterations in nociceptive input. Controlled, double-blind, cross-over. Thirty-one patients with chronic pain (trapezius myalgia) and CS after whiplash. Participants were referred by randomization to group A for injection of a single peripheral pain generator (MTrP or other discrete tender point) with local anesthetic or to group B for sham injection and cross-over. Documentation of PPT (Algometer), maximum jaw opening (caliper), and grip strength (Vigorimeter), as well as subjective overall pain (visual analog scale [VAS]), was made before and after each intervention. Statistical analysis of data (Student's t test, analysis of variance) confirmed that peripheral pain thresholds were significantly higher and maximum jaw opening significantly greater after anesthetizing a focal pain generator in the trapezius, but not after a sham injection. In contrast with the objective variables, subjective generalized pain improved (VAS) after not only an injection of local anesthetic, but also, and to a similar extent, after a sham injection. CS, as expressed by lowered PPT, is a rapidly adjusting physiological response to nociceptive stimuli in some patients with chronic pain after whiplash. PPT are likely modulated by myofascial tender points in selected patients with CS. With reference to the present findings, surgical ablation of MTrPs is discussed as a potential treatment modality for CS. © 2017 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  17. Rationale and design of the SMaRT trial: A randomised, prospective, parallel, non-blinded, one-centre trial to evaluate the use of magnetic resonance imaging in acute setting in patients presenting with suspected scaphoid fracture.

    Science.gov (United States)

    Rua, Tiago; Vijayanathan, Sanjay; Parkin, David; Goh, Vicky; McCrone, Paul; Gidwani, Sam

    2017-12-01

    Background Wrist injury is a common presentation to the Emergency Department in the United Kingdom. Among these injuries, the scaphoid is the most common fractured carpal bone. However, given the limited ability of conventional radiography to accurately diagnose a suspected scaphoid fracture on presentation, its diagnosis and management remain challenging. Despite the vast clinical evidence supporting the superior accuracy of magnetic resonance imaging, there is little to no evidence around the real-world clinical and economic impact of immediate magnetic resonance imaging in the management of suspected scaphoid fractures. Methods Review of design and implementation challenges associated with the identification and subsequent recruitment of eligible patients, implementation of a novel clinical pathway in an acute setting, rationale behind the primary and secondary outcomes selected and measurement of the primary outcome. Results The Scaphoid Magnetic Resonance Imaging in Trauma trial is a single-site prospective, randomised, non-blinded, parallel design trial that aims to evaluate the use of immediate magnetic resonance imaging in the management of patients presenting to the acute setting with suspected scaphoid fractures. The primary outcome is the total 3-month cost per patient associated with the diagnosis and treatment of suspected scaphoid fractures. It is hypothesised that the immediate use of magnetic resonance imaging, a more accurate but expensive imaging modality, in patients with negative findings in the initial four-view radiography, will reduce the overall National Health Service costs by promoting definitive care and avoiding unnecessary diagnostic and treatment procedures. Other rationale design considerations in the recruitment, randomisation, data acquisition and intervention implementation are also discussed. Several of these challenges derive from real-world operational issues associated with the provision of magnetic resonance imaging in an

  18. A randomized cross-over study of the acute effects of running 5 km on glucose, insulin, metabolic rate, cortisol and Troponin T.

    Science.gov (United States)

    Keselman, Boris; Vergara, Marta; Nyberg, Sofia; Nystrom, Fredrik H

    2017-01-01

    We aimed to study the impact by running 5 km, at maximal speed, on the normal variations of metabolic variables related to glucose, insulin, insulin sensitivity, cortisol, glucagon, Troponin T and metabolic rate. Five women and 12 men 25.7±5.2 years of age with a body-mass-index of 22.5±2.3 kg/m2 where recruited to run 5 km at individual maximal speed in the morning, and to a corresponding day of rest, followed by standardized breakfast and lunch meals. Blood sampling and measurement of indirect calorimetry were done before and after meals. The participants were randomized regarding the order of the two trial-days in this cross-over study. Insulin and cortisol levels were higher, and insulin sensitivity was lower, on the race-day compared with the day of rest (linear mixed model: pdays (p = 0.29 and p = 0.53, respectively). When analyzing specific time-points we found that glucose increased from 5.01±0.37 mmol/l to 6.36 ± 1.3 mmol/l, pindex of serum sensitivity, 1/(log10insulin+log10glucose), was lowered post-race, p<0.0001. Serum cortisol levels increased from 408±137 nmol/l to 644±171 nmol/l, p<0.0001, post-race while serum glucagon levels were unaffected. Troponin T was detectable in serum post-race in 12 out of the 17 participants and reached or surpassed the clinical reference level of 15 ng/l in three subjects. Post-race electrocardiograms displayed no pathologies. Relatively short running-races can apparently induce a reduction in insulin sensitivity that is not fully compensated by concomitantly increased insulin secretion intended to ensure euglycemia. Since also Troponin T was detected in plasma in a majority of the participants, our data suggest that it is possible to induce considerable metabolic stress by running merely 5 km, when striving for maximal speed.

  19. Pursed-lips breathing reduces dynamic hyperinflation induced by activities of daily living test in patients with chronic obstructive pulmonary disease: A randomized cross-over study.

    Science.gov (United States)

    de Araujo, Cintia Laura Pereira; Karloh, Manuela; Dos Reis, Cardine Martins; Palú, Marina; Mayer, Anamaria Fleig

    2015-11-01

    Dynamic hyperinflation leads to dyspnoea and consequent limitations in functional capacity in chronic obstructive pulmonary disease. It has been shown that the response to pursed-lips breathing in terms of dynamic hyperinflation and lower-limb exercise capacity is variable, and its effects on activities of daily living are unknown. This study aimed to evaluate the effect of pursed-lips breathing on dynamic hyperinflation and functional capacity in patients with chronic obstructive pulmonary disease in a lower-limb exercise test and in a multiple-task activities of daily living test. Randomized cross-over study. Twenty-five patients with chronic obstructive pulmonary disease (16 men, mean age 64 ± 7 years, forced expiratory volume in 1 s (FEV1) = 41.7 ± 14.7% predicted). Patients randomly performed two 6-min walk tests (6MWT) with and without pursed-lips breathing (6MWT(PLB) and 6MWT(Non-PLB)) and two Glittre-ADL tests with and without pursed-lips breathing (TGlittre(PLB) and TGlittre(Non-PLB)). Inspiratory capacity was assessed at baseline and immediately after the tests. The 6MWT(Non-PLB) and TGlittre(Non-PLB) induced similar magnitude dynamic hyperinflation (0.22 ± 0.24 l and 0.31 ± 0.23 l, respectively; p > 0.05). Pursed-lips breathing did not improve dynamic hyperinflation induced by the 6MWT (0.24 ± 0.20 and 0.22 ± 0.24 l, respectively, with and without pursed-lips breathing; p > 0.05). Dynamic hyperinflation in the TGlittre(PLB) was significantly lower than in the TGlittre(Non-PLB) (0.19 ± 0.20 l and 0.31 ± 0.23 l, respectively; p = 0.02). Pursed-lips breathing did not improve 6MWT or TGlittre performance. Pursed-lips breathing reduced dynamic hyperinflation in the TGlittre, but not in the 6MWT. However, pursed-lips breathing did not improve functional capacity.

  20. The effect of purslane seeds on glycemic status and lipid profiles of persons with type 2 diabetes: A randomized controlled cross-over clinical trial

    Directory of Open Access Journals (Sweden)

    Ahmad Esmaillzadeh

    2015-01-01

    Full Text Available Background: We are aware of limited data about the effects of purslane on diabetes. Earlier studies have mostly indicated the beneficial effects in animal models. This study aimed to evaluate the effect of purslane seeds on glycemic status and lipid profiles of persons with type 2 diabetes. Materials and Methods: This cross-over randomized controlled clinical trial was conducted on 48 persons with type 2 diabetes. Participants were randomly assigned to receive either 10 g/day purslane seeds with 240 cc low-fat yogurt (intervention group or only 240 cc low-fat yogurt (as a control group for 5 weeks. After a 2-week washout period, subjects were moved to the alternate arm for an additional 5 weeks. At baseline and end of each phase of the study, fasting blood samples were collected to quantify plasma glucose levels, as well as serum insulin and lipid profiles. Within-group and between-group changes in anthropometric measures, as well as biochemical indicators, were compared using a paired-samples t-test. Results: Mean age of study participants was 51.4 ± 6.0 year. We found a significant reduction in weight (−0.57 vs. 0.09 kg, P = 0.003 and body mass index (−0.23 vs. 0.02 kg/m 2 , P = 0.004 following purslane seeds consumption. Despite a slight reduction in fasting plasma glucose levels (−2.10 vs. −2.77 mg/dL, P = 0.90, we failed to find any significant effect on serum insulin levels and homeostatic model of assessment of insulin resistance score. Furthermore, purslane consumption decreased serum triglyceride levels (−25.5 vs. −1.8 mg/dL, P = 0.04 but could not affect serum high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and total cholesterol levels. We observed a significant reduction in systolic blood pressure (−3.33 vs. 0.5 mmHg, P = 0.01 and a borderline significant decrease in diastolic blood pressure (−3.12 vs. −0.93 mmHg, P = 0.09 after purslane seeds intake. Conclusion: In summary, consumption of

  1. Combined short- and long-axis ultrasound-guided central venous catheterization is superior to conventional techniques: A cross-over randomized controlled manikin trial.

    Directory of Open Access Journals (Sweden)

    Jun Takeshita

    Full Text Available Visualizing the needle tip using the short-axis (SA ultrasound-guided central venous catheterization approach can be challenging. It has been suggested to start the process with the SA approach and then switch to the long-axis (LA; however, to our knowledge, this combination has not been evaluated. We compared the combined short- and long-axis (SLA approach with the SA approach in a manikin study.We performed a prospective randomized controlled cross-over study in an urban emergency department and intensive care unit. Resident physicians in post-graduate years 1-2 performed a simulated ultrasound-guided internal jugular vein puncture using the SA and SLA approaches on manikins. Twenty resident physicians were randomly assigned to two equal groups: (1 one group performed punctures using the SA approach followed by SLA; and (2 the other performed the same procedures in the opposite order. We compared the success rate and procedure duration for the two approaches. Procedural success was defined as insertion of the guide-wire into the vein while visualizing the needle tip at the time of anterior wall puncture, without penetrating the posterior wall.Six resident physicians (30% performed both approaches successfully, while 12 (60% performed the SLA approach, but not the SA, successfully. Those who performed the SA approach successfully also succeeded with the SLA approach. Two resident physicians (10% failed to perform both approaches. The SLA approach had a significantly higher success rate than the SA approach (P < 0.001. The median (interquartile range procedure duration was 59.5 [46.0-88.5] seconds and 45.0 [37.5-84.0] seconds for the SLA and SA approaches, respectively. The difference of the duration between the two procedures was 15.5 [0-28.5] seconds. There was no significant difference in duration between the two approaches (P = 0.12.Using the SLA approach significantly improved the success rate of internal jugular vein puncture performed by

  2. [The blindness in the literature-Jose Saramago: blindness and Albert Bang: the blind witness].

    Science.gov (United States)

    Permin, H; Norn, M

    2001-01-01

    Two novels with different aspects of blindness seen through the doctors eyes. The Portuguese Nobel-prize winner José Saramago's story of a city struck by an epidemic of "white blindness", where the truth is what we cannot bear to see. The Danish author and unskilled labourer Albert Bang's (synonym with Karl E. Rasmussen) crime novel describes a blind or pretend to be blind butcher, who is a witness to a murder. Both novels are lyric, thought-provoking and insightful.

  3. Blind Compressed Sensing

    OpenAIRE

    Gleichman, Sivan; Eldar, Yonina C.

    2011-01-01

    The fundamental principle underlying compressed sensing is that a signal, which is sparse under some basis representation, can be recovered from a small number of linear measurements. However, prior knowledge of the sparsity basis is essential for the recovery process. This work introduces the concept of blind compressed sensing, which avoids the need to know the sparsity basis in both the sampling and the recovery process. We suggest three possible constraints on the sparsity basis that can ...

  4. [Blindness and visual rehabilitation].

    Science.gov (United States)

    Matonti, F; Roux, S; Denis, D; Picaud, S; Chavane, F

    2015-02-01

    Blindness and visual impairment are a major public health problem all over the world and in all societies. A large amount of basic science and clinical research aims to rehabilitate patients and help them become more independent. Various methods are explored from cell and molecular therapy to prosthetic interfaces. We review the various treatment alternatives, describing their results and their limitations. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  5. INTRODUCTION Childhood blindness is increasingly becoming a ...

    African Journals Online (AJOL)

    number of blind years resulting from blindness in children is also equal to the number of blind years due to age related cataract.10 The burden of disability in terms of blind years in these children represents a major. CAUSES OF BLINDNESS AND VISUAL IMPAIRMENT AT THE SCHOOL FOR THE. BLIND OWO, NIGERIA.

  6. Stochastic Blind Motion Deblurring

    KAUST Repository

    Xiao, Lei

    2015-05-13

    Blind motion deblurring from a single image is a highly under-constrained problem with many degenerate solutions. A good approximation of the intrinsic image can therefore only be obtained with the help of prior information in the form of (often non-convex) regularization terms for both the intrinsic image and the kernel. While the best choice of image priors is still a topic of ongoing investigation, this research is made more complicated by the fact that historically each new prior requires the development of a custom optimization method. In this paper, we develop a stochastic optimization method for blind deconvolution. Since this stochastic solver does not require the explicit computation of the gradient of the objective function and uses only efficient local evaluation of the objective, new priors can be implemented and tested very quickly. We demonstrate that this framework, in combination with different image priors produces results with PSNR values that match or exceed the results obtained by much more complex state-of-the-art blind motion deblurring algorithms.

  7. THE INFLUENCE OF CHRONIC TREATMENT WITH BETA-BLOCKADE AND ANGIOTENSIN-CONVERTING ENZYME-INHIBITION ON THE PERIPHERAL-BLOOD FLOW IN HYPERTENSIVE PATIENTS WITH AND WITHOUT CONCOMITANT INTERMITTENT CLAUDICATION - A COMPARATIVE CROSS-OVER TRIAL

    NARCIS (Netherlands)

    VANDEVEN, LLM; VANLEEUWEN, JTM; SMIT, AJ

    1994-01-01

    In a comparative cross-over trial we examined the influence of the betablocker bisoprolol and the ACE-inhibitor lisinopril on the peripheral blood flow of 2 groups of hypertensive patients with and without concomitant intermittent claudication. In 11 patients with hypertension without peripheral

  8. Blind-date Conversation Joining

    Directory of Open Access Journals (Sweden)

    Luca Cesari

    2013-07-01

    Full Text Available We focus on a form of joining conversations among multiple parties in service-oriented applications where a client may asynchronously join an existing conversation without need to know in advance any information about it. More specifically, we show how the correlation mechanism provided by orchestration languages enables a form of conversation joining that is completely transparent to clients and that we call 'blind-date joining'. We provide an implementation of this strategy by using the standard orchestration language WS-BPEL. We then present its formal semantics by resorting to COWS, a process calculus specifically designed for modelling service-oriented applications. We illustrate our approach by means of a simple, but realistic, case study from the online games domain.

  9. Design and pilot results of a single blind randomized controlled trial of systematic demand-led home visits by nurses to frail elderly persons in primary care [ISRCTN05358495

    Directory of Open Access Journals (Sweden)

    Tybout Willemijn

    2005-09-01

    Full Text Available Abstract Background The objective of this article is to describe the design of an evaluation of the cost-effectiveness of systematic home visits by nurses to frail elderly primary care patients. Pilot objectives were: 1. To determine the feasibility of postal multidimensional frailty screening instruments; 2. to identify the need for home visits to elderly. Methods Main study: The main study concerns a randomized controlled in primary care practices (PCP with 18 months follow-up and blinded PCPs. Frail persons aged 75 years or older and living at home but neither terminally ill nor demented from 33 PCPs were eligible. Trained community nurses (1 visit patients at home and assess the care needs with the Resident Assessment Instrument-Home Care, a multidimensional computerized geriatric assessment instrument, enabling direct identification of problem areas; (2 determine the care priorities together with the patient; (3 design and execute interventions according to protocols; (4 and visit patients at least five times during a year in order to execute and monitor the care-plan. Controls receive usual care. Outcome measures are Quality of life, and Quality Adjusted Life Years; time to nursing home admission; mortality; hospital admissions; health care utilization. Pilot 1: Three brief postal multidimensional screening measures to identify frail health among elderly persons were tested on percentage complete item response (selected after a literature search: 1 Vulnerable Elders Screen, 2 Strawbridge's frailty screen, and 3 COOP-WONCA charts. Pilot 2: Three nurses visited elderly frail patients as identified by PCPs in a health center of 5400 patients and used an assessment protocol to identify psychosocial and medical problems. The needs and experiences of all participants were gathered by semi-structured interviews. Discussion The design holds several unique elements such as early identification of frail persons combined with case-management by

  10. A healthy diet with and without cereal grains and dairy products in patients with type 2 diabetes: study protocol for a random-order cross-over pilot study - Alimentation and Diabetes in Lanzarote -ADILAN

    Science.gov (United States)

    2014-01-01

    Background Research on the role of nutrition in type 2 diabetes has largely focused on macro/micronutrient composition and dietary fiber intake, while fewer studies have tested the effects of differing food choice. Some observational studies and short-term intervention studies suggest that a food pattern mimicking the diet with which humans evolved positively influences glucose control and associated endocrine systems. Such a food pattern mainly differs from other common healthy food patterns in its absence of cereal grains and dairy products. The primary aim of this pilot study is to determine the effect of two healthy diets with or without cereal grains and dairy products on glucose control, while keeping participants’ weight stable and other food parameters, such as macro/micronutrient composition, dietary fiber and glycemic load, the same in both diets. Methods/Design We intend to include 15 adult patients with a medical diagnosis of type 2 diabetes mellitus with or without medication and with an increased waist circumference (≥ 80 cm for women and ≥ 94 cm for men) in a random-order cross-over diet intervention study during two periods of four-weeks separated by a six-week washout period. Patients will be instructed to eat two healthy diets according to official dietary guidelines with respect to macro/micronutrient composition and fiber content, but differing in the type of food included, with one diet being without cereal grains and dairy products. Lunch will be served in a hospital kitchen for control of nutrient intake, while the rest of the meals will be eaten at home according to specific directions. The energy content of the diets will be individually adjusted to maintain a stable body weight during the two four-week intervention periods. Primary outcomes will be change in fasting plasma glucagon and fructosamine, while secondary outcomes include change in fasting glucose and glycated hemoglobin, glucose and glucagon response during oral

  11. Design and methods of the Echo WISELY (Will Inappropriate Scenarios for Echocardiography Lessen SignificantlY) study: An investigator-blinded randomized controlled trial of education and feedback intervention to reduce inappropriate echocardiograms.

    Science.gov (United States)

    Bhatia, R Sacha; Ivers, Noah; Yin, Cindy X; Myers, Dorothy; Nesbitt, Gillian; Edwards, Jeremy; Yared, Kibar; Wadhera, Rishi; Wu, Justina C; Wong, Brian; Hansen, Mark; Weinerman, Adina; Shadowitz, Steven; Johri, Amer; Farkouh, Michael; Thavendiranathan, Paaladinesh; Udell, Jacob A; Rambihar, Sherryn; Chow, Chi-Ming; Hall, Judith; Thorpe, Kevin E; Rakowski, Harry; Weiner, Rory B

    2015-08-01

    Appropriate use criteria (AUC) for transthoracic echocardiography (TTE) were developed to address concerns regarding inappropriate use of TTE. A previous pilot study suggests that an educational and feedback intervention can reduce inappropriate TTEs ordered by physicians in training. It is unknown if this type of intervention will be effective when targeted at attending level physicians in a variety of clinical settings. The aim of this international, multicenter study is to evaluate the hypothesis that an AUC-based educational and feedback intervention will reduce the proportion of inappropriate echocardiograms ordered by attending physicians in the ambulatory environment. In an ongoing multicentered, investigator-blinded, randomized controlled trial across Canada and the United States, cardiologists and primary care physicians practicing in the ambulatory setting will be enrolled. The intervention arm will receive (1) a lecture outlining the AUC and most recent available evidence highlighting appropriate use of TTE, (2) access to the American Society of Echocardiography mobile phone app, and (3) individualized feedback reports e-mailed monthly summarizing TTE ordering behavior including information on inappropriate TTEs and brief explanations of the inappropriate designation. The control group will receive no education on TTE appropriate use and order TTEs as usual practice. The Echo WISELY (Will Inappropriate Scenarios for Echocardiography Lessen Significantly in an education RCT) study is the first multicenter randomized trial of an AUC-based educational intervention. The study will examine whether an education and feedback intervention will reduce the rate of outpatient inappropriate TTEs ordered by attending level cardiologists and primary care physicians (www.clinicaltrials.gov identifier NCT02038101). Copyright © 2015 Elsevier Inc. All rights reserved.

  12. RUDO: A Home Ambient Intelligence System for Blind People.

    Science.gov (United States)

    Hudec, Milan; Smutny, Zdenek

    2017-08-22

    The article introduces an ambient intelligence system for blind people which besides providing assistance in home environment also helps with various situations and roles in which blind people may find themselves involved. RUDO, the designed system, comprises several modules that mainly support or ensure recognition of approaching people, alerting to other household members' movement in the flat, work on a computer, supervision of (sighted) children, cooperation of a sighted and a blind person (e.g., when studying), control of heating and zonal regulation by a blind person. It has a unified user interface that gives the blind person access to individual functions. The interface for blind people offers assistance with work on a computer, including writing in Braille on a regular keyboard and specialized work in informatics and electronics (e.g., programming). RUDO can complement the standard aids used by blind people at home, it increases their independence and creates conditions that allow them to become fully involved. RUDO also supports blind people sharing a home with sighted people, which contributes to their feeling of security and greater inclusion in society. RUDO has been implemented in a household for two years, which allows an evaluation of its use in practice.

  13. Causes of blindness among hospital outpatients in Ecuador.

    Science.gov (United States)

    Cass, Helene; Landers, John; Benitez, Paul

    2006-03-01

    There is a lack of published information on the causes of blindness in Ecuador and the Latin American region in general. This study is designed to enumerate the proportions of ocular conditions contributing to blindness in an outpatient population of an ophthalmology hospital in the coastal region of Ecuador. All cases presenting to an ophthalmology outpatient clinic over a 3-week period during September 2004 were reviewed (n = 802). Visual acuity was measured using a Snellen acuity chart and those who met the criteria for blindness were included in the study (n = 118). Blindness was defined under the World Health Organization protocol as visual acuity of glaucoma (15%). Among those considered to have bilateral blindness (n = 30), refraction was the most common cause (37%), followed by cataract (23%) and glaucoma (17%). The major causes of blindness found in this study reflected those in estimated data for the region. More studies are needed to improve the quality and quantity of epidemiological data on blindness in Ecuador and Latin America. Many obstacles to successful implementation of prevention of blindness programmes in South America still need to be overcome.

  14. “Is powered toothbrush better than manual toothbrush in removing dental plaque?” – A crossover randomized double-blind study among differently abled, India

    Science.gov (United States)

    Neelima, Mallam; Chandrashekar, Byalakere Rudraiah; Goel, Shubhi; Sushma, Rudraswamy; Srilatha, Yarramasu

    2017-01-01

    Background: Although mechanical plaque removal is an effective method, powered toothbrushes are specially designed to benefit differently abled. Literature comparing plaque removal efficacy between manual and powered toothbrushes among differently abled is sparse. Study Design and Setting: A cross-over, randomized, double-blind study was conducted in differently abled institution. Materials and Methods: Twenty differently abled participants were randomly assigned to two groups of ten participants. Plaque removal efficacy of battery-operated powered toothbrush was compared with manual toothbrush in a single brushing on the 8th day. After a washout of 1 week, groups were switched. Assessment of plaque scores was done using Turesky's modification of Quigley-Hein plaque index. Statistical Analysis: Difference in plaque score between pre- and post-brushing in each group was compared using paired sample t-test. Results: In the pooled data analysis combining the results of Phase I and II, mean pre- and post-brushing plaque scores with manual toothbrush was 2.26 ± 0.4 and 1.93 ± 0.5, respectively, while with powered toothbrush, it was 2.21 ± 0.4 and 1.96 ± 0.4, respectively. However, difference in mean plaque reduction between manual and powered toothbrushes was not significant. Conclusion: Manual toothbrushes were equally effective compared to powered toothbrushes. Long-term studies precisely documenting cost-effectiveness and participant perception in the ease of use are recommended to validate our results. PMID:29398859

  15. Vision after 53 years of blindness.

    Science.gov (United States)

    Sikl, Radovan; Simecček, Michal; Porubanová-Norquist, Michaela; Bezdíček, Ondřej; Kremláček, Jan; Stodůlka, Pavel; Fine, Ione; Ostrovsky, Yuri

    2013-01-01

    Several studies have shown that visual recovery after blindness that occurs early in life is never complete. The current study investigated whether an extremely long period of blindness might also cause a permanent impairment of visual performance, even in a case of adult-onset blindness. We examined KP, a 71-year-old man who underwent a successful sight-restoring operation after 53 years of blindness. A set of psychophysical tests designed to assess KP's face perception, object recognition, and visual space perception abilities were conducted six months and eight months after the surgery. The results demonstrate that regardless of a lengthy period of normal vision and rich pre-accident perceptual experience, KP did not fully integrate this experience, and his visual performance remained greatly compromised. This was particularly evident when the tasks targeted finer levels of perceptual processing. In addition to the decreased robustness of his memory representations, which was hypothesized as the main factor determining visual impairment, other factors that may have affected KP's performance were considered, including compromised visual functions, problems with perceptual organization, deficits in the simultaneous processing of visual information, and reduced cognitive abilities.

  16. Vision after 53 Years of Blindness

    Directory of Open Access Journals (Sweden)

    Radovan Šikl

    2013-12-01

    Full Text Available Several studies have shown that visual recovery after blindness that occurs early in life is never complete. The current study investigated whether an extremely long period of blindness might also cause a permanent impairment of visual performance, even in a case of adult-onset blindness. We examined KP, a 71-year-old man who underwent a successful sight-restoring operation after 53 years of blindness. A set of psychophysical tests designed to assess KP's face perception, object recognition, and visual space perception abilities were conducted six months and eight months after the surgery. The results demonstrate that regardless of a lengthy period of normal vision and rich pre-accident perceptual experience, KP did not fully integrate this experience, and his visual performance remained greatly compromised. This was particularly evident when the tasks targeted finer levels of perceptual processing. In addition to the decreased robustness of his memory representations, which was hypothesized as the main factor determining visual impairment, other factors that may have affected KP's performance were considered, including compromised visual functions, problems with perceptual organization, deficits in the simultaneous processing of visual information, and reduced cognitive abilities.

  17. Early vision impairs tactile perception in the blind.

    Science.gov (United States)

    Röder, Brigitte; Rösler, Frank; Spence, Charles

    2004-01-20

    Researchers have known for more than a century that crossing the hands can impair both tactile perception and the execution of appropriate finger movements. Sighted people find it more difficult to judge the temporal order when two tactile stimuli, one applied to either hand, are presented and their hands are crossed over the midline as compared to when they adopt a more typical uncrossed-hands posture. It has been argued that because of the dominant role of vision in motor planning and execution, tactile stimuli are remapped into externally defined coordinates (predominantly determined by visual inputs) that takes longer to achieve when external and body-centered codes (determined primarily by somatosensory/proprioceptive inputs) are in conflict and that involves both multisensory parietal and visual cortex. Here, we show that the performance of late, but not of congenitally, blind people was impaired by crossing the hands. Moreover, we provide the first empirical evidence for superior temporal order judgments (TOJs) for tactile stimuli in the congenitally blind. These findings suggest a critical role of childhood vision in modulating the perception of touch that may arise from the emergence of specific crossmodal links during development.

  18. Comparison between Steroid Injection and Stretching Exercise on the Scalene of Patients with Upper Extremity Paresthesia: Randomized Cross-Over Study.

    Science.gov (United States)

    Kim, Yong Wook; Yoon, Seo Yeon; Park, Yongbum; Chang, Won Hyuk; Lee, Sang Chul

    2016-03-01

    To compare the therapeutic effects on upper extremity paresthesia of intra-muscular steroid injections into the scalene muscle with those of stretching exercise only. Twenty patients with upper extremity paresthesia who met the criteria were recruited to participate in this single-blind, crossover study. Fourteen of 20 patients were female. The average age was 45.0 ± 10.5 years and duration of symptom was 12.2 ± 8.7 months. Each participant completed one injection and daily exercise program for 2 weeks. After randomization, half of all patients received ultrasound-guided injection of scalene muscles before exercise, while the other was invested for the other patients. After two weeks, there was a significant decrease of the visual analog scale score of treatment effect compared with baseline in both groups (6.90 to 2.85 after injection and 5.65 to 4.05 after stretching exercise, pstretching exercise (p50% reduction in post-treatment visual analog scale, was 18 of 20 (90.0%) after injection, compared to 5 of 20 (25.0%) after stretching exercise. There were no cases of unintended brachial plexus block after injection. Ultrasound-guided steroid injection or stretching exercise of scalene muscles led to reduced upper extremity paresthesia in patients who present with localized tenderness in the scalene muscle without electrodiagnostic test abnormalities, although injection treatment resulted in more improvements. The results suggest that symptoms relief might result from injection into the muscle alone not related to blockade of the brachial plexus.

  19. Education Game to Blind People

    Directory of Open Access Journals (Sweden)

    Lidya Oktorina Kusuma Sakti

    2015-11-01

    Now there are blind people who have their formal and informal education. Even though they cannot see, they can take benefit from another sense, like sense of hearing, palpability, smell, and taste. Their senses can be a modal to study. Developer games have their build game in audio to blind people too. Their game is variation between audio games and online games, so games can be used for blind people as an education tools. In this paper, there will be an explanation about how to facilitate blind people to study with paper

  20. Blind Quantum Computation

    DEFF Research Database (Denmark)

    Salvail, Louis; Arrighi, Pablo

    2006-01-01

    We investigate the possibility of "having someone carry out the work of executing a function for you, but without letting him learn anything about your input". Say Alice wants Bob to compute some known function f upon her input x, but wants to prevent Bob from learning anything about x. The situa......We investigate the possibility of "having someone carry out the work of executing a function for you, but without letting him learn anything about your input". Say Alice wants Bob to compute some known function f upon her input x, but wants to prevent Bob from learning anything about x....... The situation arises for instance if client Alice has limited computational resources in comparison with mistrusted server Bob, or if x is an inherently mobile piece of data. Could there be a protocol whereby Bob is forced to compute f(x) "blindly", i.e. without observing x? We provide such a blind computation...... protocol for the class of functions which admit an efficient procedure to generate random input-output pairs, e.g. factorization. The cheat-sensitive security achieved relies only upon quantum theory being true. The security analysis carried out assumes the eavesdropper performs individual attacks....

  1. A healthy diet with and without cereal grains and dairy products in patients with type 2 diabetes: study protocol for a random-order cross-over pilot study--Alimentation and Diabetes in Lanzarote--ADILAN.

    Science.gov (United States)

    Fontes-Villalba, Maelán; Jönsson, Tommy; Granfeldt, Yvonne; Frassetto, Lynda A; Sundquist, Jan; Sundquist, Kristina; Carrera-Bastos, Pedro; Fika-Hernándo, María; Picazo, Óscar; Lindeberg, Staffan

    2014-01-02

    Research on the role of nutrition in type 2 diabetes has largely focused on macro/micronutrient composition and dietary fiber intake, while fewer studies have tested the effects of differing food choice. Some observational studies and short-term intervention studies suggest that a food pattern mimicking the diet with which humans evolved positively influences glucose control and associated endocrine systems. Such a food pattern mainly differs from other common healthy food patterns in its absence of cereal grains and dairy products. The primary aim of this pilot study is to determine the effect of two healthy diets with or without cereal grains and dairy products on glucose control, while keeping participants' weight stable and other food parameters, such as macro/micronutrient composition, dietary fiber and glycemic load, the same in both diets. We intend to include 15 adult patients with a medical diagnosis of type 2 diabetes mellitus with or without medication and with an increased waist circumference (≥ 80 cm for women and ≥ 94 cm for men) in a random-order cross-over diet intervention study during two periods of four-weeks separated by a six-week washout period. Patients will be instructed to eat two healthy diets according to official dietary guidelines with respect to macro/micronutrient composition and fiber content, but differing in the type of food included, with one diet being without cereal grains and dairy products. Lunch will be served in a hospital kitchen for control of nutrient intake, while the rest of the meals will be eaten at home according to specific directions. The energy content of the diets will be individually adjusted to maintain a stable body weight during the two four-week intervention periods. Primary outcomes will be change in fasting plasma glucagon and fructosamine, while secondary outcomes include change in fasting glucose and glycated hemoglobin, glucose and glucagon response during oral glucose tolerance test, blood

  2. Efficacy of various types of laryngoscope (direct, Pentax Airway Scope and GlideScope) for endotracheal intubation in various cervical immobilisation scenarios: a randomised cross-over simulation study

    Science.gov (United States)

    Kim, Jong Won; Lee, Kyeong Ryong; Hong, Dae Young; Baek, Kwang Je; Lee, Young Hwan; Park, Sang O

    2016-01-01

    Objective To compare the efficacy of direct laryngoscopy (DL), Pentax Airway Scope (PAWS) and GlideScope video laryngoscope (GVL) systems for endotracheal intubation (ETI) in various cervical immobilisation scenarios: manual in-line stabilisation (MILS), Philadelphia neck collar (PNC) (moderate limit of mouth opening) and Stifneck collar (SNC) (severe limit of mouth opening). Design Randomised cross-over simulation study. Setting and Participants 35 physicians who had >30 successful ETI experiences at a tertiary hospital in Seoul, Korea. Primary and secondary outcome measures Participants performed ETI using PAWS, GVL and DL randomly in simulated MILS, PNC and SNC scenarios in our simulation centre. The end points were successful ETI and the time to complete ETI. In addition, modified Cormack-Lehane (CL) classification and pressure to teeth were recorded. Results In MILS, there were no significant differences in the rate of success of ETI between the three devices: 33/35(94.3%) for DL vs 32/35(91.4%) for GVL vs 35/35(100.0%) for PAWS; p=0.230). PAWS achieved successful ETI more quickly (19.8 s) than DL (29.6 s) and GVL (35.4 s). For the PNC scenario, a higher rate of successful ETI was achieved with GVL 33/35 (94.3%) than PAWS 29/35 (82.9%) or DL 25/35 (71.4%) (p=0.040). For the SNC scenario, a higher rate of successful ETI was achieved with GVL 28/35(80.0%) than with DL 14/35(40.0%) and PAWS 7/35(20.0%) (p<0.001). For the PNC and SNC scenarios, GVL provided a relatively good view of the glottis, but a frequent pressure to teeth occurred. Conclusions All three devices are suitable for ETI in MILS. DL is not suitable in both neck collar scenarios. PAWS showed faster intubations in MILS, but was not suitable in the SNC scenario. GVL is most suitable in all cervical immobilisation scenarios, but may cause pressure to teeth more frequently. PMID:27797983

  3. Static platelet adhesion, flow cytometry and serum TXB2 levels for monitoring platelet inhibiting treatment with ASA and clopidogrel in coronary artery disease: a randomised cross-over study

    Directory of Open Access Journals (Sweden)

    Hedbäck Bo

    2009-06-01

    Full Text Available Abstract Background Despite the use of anti-platelet agents such as acetylsalicylic acid (ASA and clopidogrel in coronary heart disease, some patients continue to suffer from atherothrombosis. This has stimulated development of platelet function assays to monitor treatment effects. However, it is still not recommended to change treatment based on results from platelet function assays. This study aimed to evaluate the capacity of a static platelet adhesion assay to detect platelet inhibiting effects of ASA and clopidogrel. The adhesion assay measures several aspects of platelet adhesion simultaneously, which increases the probability of finding conditions sensitive for anti-platelet treatment. Methods With a randomised cross-over design we evaluated the anti-platelet effects of ASA combined with clopidogrel as well as monotherapy with either drug alone in 29 patients with a recent acute coronary syndrome. Also, 29 matched healthy controls were included to evaluate intra-individual variability over time. Platelet function was measured by flow cytometry, serum thromboxane B2 (TXB2-levels and by static platelet adhesion to different protein surfaces. The results were subjected to Principal Component Analysis followed by ANOVA, t-tests and linear regression analysis. Results The majority of platelet adhesion measures were reproducible in controls over time denoting that the assay can monitor platelet activity. Adenosine 5'-diphosphate (ADP-induced platelet adhesion decreased significantly upon treatment with clopidogrel compared to ASA. Flow cytometric measurements showed the same pattern (r2 = 0.49. In opposite, TXB2-levels decreased with ASA compared to clopidogrel. Serum TXB2 and ADP-induced platelet activation could both be regarded as direct measures of the pharmacodynamic effects of ASA and clopidogrel respectively. Indirect pharmacodynamic measures such as adhesion to albumin induced by various soluble activators as well as SFLLRN

  4. POSTERIOR SEGMENT CAUSES OF BLINDNESS AMONG CHILDREN IN BLIND SCHOOLS

    Directory of Open Access Journals (Sweden)

    Sandhya

    2015-09-01

    Full Text Available BACKGROUND: It is estimated that there are 1.4 million irreversibly blind children in the world out of which 1 million are in Asia alone. India has the highest number of blind children than any other country. Nearly 70% of the childhood blindness is avoidable. There i s paucity of data available on the causes of childhood blindness. This study focuses on the posterior segment causes of blindness among children attending blind schools in 3 adjacent districts of Andhra Pradesh. MATERIAL & METHODS: This is a cross sectiona l study conducted among 204 blind children aged 6 - 16 years age. Detailed eye examination was done by the same investigator to avoid bias. Posterior segment examination was done using a direct and/or indirect ophthalmoscope after dilating pupil wherever nec essary. The standard WHO/PBL for blindness and low vision examination protocol was used to categorize the causes of blindness. A major anatomical site and underlying cause was selected for each child. The study was carried out during July 2014 to June 2015 . The results were analyzed using MS excel software and Epi - info 7 software version statistical software. RESULTS: Majority of the children was found to be aged 13 - 16 years (45.1% and males (63.7%. Family history of blindness was noted in 26.0% and consa nguinity was reported in 29.9% cases. A majority of them were belonged to fulfill WHO grade of blindness (73.0% and in majority of the cases, the onset of blindness was since birth (83.7%. The etiology of blindness was unknown in majority of cases (57.4% while hereditary causes constituted 25.4% cases. Posterior segment causes were responsible in 33.3% cases with retina being the most commonly involved anatomical site (19.1% followed by optic nerve (14.2%. CONCLUSIONS: There is a need for mandatory oph thalmic evaluation, refraction and assessment of low vision prior to admission into blind schools with periodic evaluation every 2 - 3 years

  5. RETENTION OF HIGH TACTILE ACUITY THROUGHOUT THE LIFESPAN IN BLINDNESS

    OpenAIRE

    Legge, Gordon E.; Madison, Cindee; Vaughn, Brenna N.; Cheong, Allen M.Y.; Miller, Joseph C.

    2008-01-01

    Previous studies of tactile acuity on the fingertip using passive touch have demonstrated an age-related decline in spatial resolution for both sighted and blind subjects. We have re-examined this age dependence with two newly designed tactile-acuity charts requiring active exploration of the test symbols. One chart used dot patterns similar to Braille and the other used embossed Landolt rings. Groups of blind Braille readers and sighted subjects, ranging in age from 12 to 85 years, were test...

  6. iShoes for blind and visually impaired people

    OpenAIRE

    Assairi, Bandar; Holmes, Violeta

    2013-01-01

    This paper presents the development of an iShoes system for blind and visually impaired people. The iShoes system utilizes a microcontroller with sound output interfaced with ultrasonic sensors. The prototype system is designed to be specifically mounted on/in the shoes to aid navigation in urban routes. The ultrasonic transducers determine the range from an obstacle and then play an audio message to reflect the distance from the target. This system will assist blind and visually impaired peo...

  7. TOOLS TO INCLUDE BLIND STUDENTS IN SCHOOL BUILDING PERFORMANCE ASSESSMENTS

    Directory of Open Access Journals (Sweden)

    Tania Pietzschke Abate

    2016-05-01

    Full Text Available This article discusses the design of data collection instruments that include the opinions of blind students, in accordance with the principles of Universal Design (UD. The aim of this study is to understand the importance of adapting data collection instruments for the inclusion of disabled persons in field research in Architecture and Design, among other fields. The data collection instruments developed were a play interview with a tactile map and a 3D survey with the use of tactile models. These instruments sought to assess the school environment experienced by blind students. The study involved students from the early years of a school for the blind who had not yet mastered the Braille system. The participation of these students was evaluated. A multidisciplinary team consisting of architects, designers, educators, and psychologists lent support to the study. The results showed that the data collection instruments adapted to blind students were successful in making the group of authors examine questions regarding UD. An analysis of the participatory phase showed that the limitations resulting from blindness determine the specificities in the adaptation and implementation process of the instruments in schools. Practical recommendations for future studies related to instruments in the UD thematic are presented. This approach is in line with the global trend of including disabled persons in society based on these users’ opinions concerning what was designed by architects and designers.

  8. A Randomized Cross-over Air Filtration Intervention Trial for Reducing Cardiovascular Health Risks in Residents of Public Housing near a Highway

    Directory of Open Access Journals (Sweden)

    Luz T. Padró-Martínez

    2015-07-01

    Full Text Available Exposure to traffic-generated ultrafine particles (UFP; particles <100 nm is likely a risk factor for cardiovascular disease. We conducted a trial of high-efficiency particulate arrestance (HEPA filtration in public housing near a highway. Twenty residents in 19 apartments living <200 m from the highway participated in a randomized, double-blind crossover trial. A HEPA filter unit and a particle counter (measuring particle number concentration (PNC, a proxy for UFP were installed in living rooms. Participants were exposed to filtered air for 21 days and unfiltered air for 21 days. Blood samples were collected and blood pressure measured at days 0, 21 and 42 after a 12-hour fasting period. Plasma was analyzed for high sensitivity C-reactive protein (hsCRP, interleukin-6 (IL-6, tumor necrosis factor alpha-receptor II (TNF-RII and fibrinogen. PNC reductions ranging from 21% to 68% were recorded in 15 of the apartments. We observed no significant differences in blood pressure or three of the four biomarkers (hsCRP, fibrinogen, and TNF-RII measured in participants after 21-day exposure to HEPA-filtered air compared to measurements after 21-day exposure to sham-filtered air. In contrast, IL-6 concentrations were significantly higher following HEPA filtration (0.668 pg/mL; CI = 0.465–0.959 compared to sham filtration. Likewise, PNC adjusted for time activity were associated with increasing IL-6 in 14- and 21-day moving averages, and PNC was associated with decreasing blood pressure in Lags 0, 1 and 2, and in a 3-day moving average. These negative associations were unexpected and could be due to a combination of factors including exposure misclassification, unsuccessful randomization (i.e., IL-6 and use of anti-inflammatory medicines, or uncontrolled confounding. Studies with greater reduction in UFP levels and larger sample sizes are needed. There also needs to be more complete assessment of resident time activity and of outdoor vs. indoor source

  9. Prevalence and causes of low vision and blindness in the blind population supported by the Yazd Welfare Organization

    Directory of Open Access Journals (Sweden)

    F Ezoddini - Ardakani

    2006-01-01

    Full Text Available Introduction: In 1995, the World Health Organization (WHO estimated that there were 37.1 million blind people worldwide. It has subsequently been reported that 110 million people have severely impaired vision, hence are at great risk of becoming blind. Watkins predicted an annual increase of about two million blind worldwide. This study was designed to investigate the causes of blindness and low vision in the blind population supported by the welfare organization of Yazd, Iran. Methods: This clinical descriptive cross-sectional study was done from January to September, 2003. In total, 109 blind patients supported by the welfare organization were included in this study. All data was collected by standard methods using questionnaire, interview and specific examination. The data included; demographic characteristics, clinical states, ophthalmic examination, family history and the available prenatal information. The data were analyzed by SPSS software and chi square test. Results: Of total patients, 73 cases were male (67% and 36 were female (33%. The median age was 24.6 years (range one month to 60 years. More than half of the cases (53.2% could be diagnosed in children less than one year of age. In total, 79 patients (88.1% were legally blind of which 23 cases (29.1% had no light perception (NLP. The most common causes of blindness were retinitis pigmentosa (32.1% followed by ocular dysgenesis (16.5%. Conclusion: Our data showed that more than half of the blindness cases occur during the first year of life. The most common cause of blindness was retinitis pigmentosa followed by ocular dysgenesis, cataract and glaucoma, respectively.

  10. Design

    DEFF Research Database (Denmark)

    Volf, Mette

    This publication is unique in its demystification and operationalization of the complex and elusive nature of the design process. The publication portrays the designer’s daily work and the creative process, which the designer is a part of. Apart from displaying the designer’s work methods...... and design parameters, the publication shows examples from renowned Danish design firms. Through these examples the reader gets an insight into the designer’s reality....

  11. Reversible blindness in fulminating preeclampsia

    African Journals Online (AJOL)

    Tung CF, Peng YC, Chen GH, Chow WK, Yang DY, Hu WH. Hemolysis, elevated liver enzymes and low platelet count. (HELLP) syndrome with acute cortical blindness. Chin. Med J (Taipei) 2001;64:482-5. 5. Cunningham FG, Fernandez CO, Hernandez C. Blindness associated with preeclampsia and eclampsia. Am J.

  12. Overview on Deaf-Blindness

    Science.gov (United States)

    Miles, Barbara

    2008-01-01

    It may seem that deaf-blindness refers to a total inability to see or hear. However, in reality deaf-blindness is a condition in which the combination of hearing and visual losses in children cause "such severe communication and other develop mental and educational needs that they cannot be accommodated in special education programs solely for…

  13. PHYSICAL DEVELOPMENT OF BLIND CHILDREN

    Directory of Open Access Journals (Sweden)

    Mira CVETKOVA

    1998-12-01

    Full Text Available A review is made on the research and studies concerning physical and motor development of blind children. An emphasis is also put on development of hand movements as part of the whole motor development process of the blind.

  14. Influence of a user-adaptive prosthetic knee on quality of life, balance confidence, and measures of mobility: a randomised cross-over trial

    NARCIS (Netherlands)

    Prinsen, Erik Christiaan; Nederhand, Marcus Johannes; Rietman, Johan Swanik; Koopman, Hubertus F.J.M.

    2015-01-01

    Objective: To study the influence of a transition from a non-microprocessor controlled to the Rheo Knee® II on quality of life, balance confidence and measures of mobility. Design: Randomised crossover trial. Setting: Research department of a rehabilitation centre. Subjects: Persons with a

  15. Explicit feedback to enhance the effect of an interim assessment: a cross-over study on learning effect and gender difference

    NARCIS (Netherlands)

    Olde Bekkink, M.; Donders, R.; van Muijen, G.N.; de Waal, R.M.; Ruiter, D.J.

    2012-01-01

    In a previous study we demonstrated by a prospective controlled design that an interim assessment during an ongoing small group work (SGW) session resulted in a higher score in the course examination. As this reflects the so-called testing effect, which is supposed to be enhanced by feedback, we

  16. Adenosine 5 '-triphosphate (ATP) supplements are not orally bioavailable: a randomized, placebo-controlled cross-over trial in healthy humans

    NARCIS (Netherlands)

    Arts, I.C.W.; Coolen, E.J.C.M.; Bours, M.J.L.; Huyghebaert, N.; Cohen Stuart, M.A.; Bast, A.; Dagnelie, P.C.

    2012-01-01

    Background: Nutritional supplements designed to increase adenosine 5'-triphosphate (ATP) concentrations are commonly used by athletes as ergogenic aids. ATP is the primary source of energy for the cells, and supplementation may enhance the ability to maintain high ATP turnover during high-intensity

  17. Calendar systems and communication of deaf-blind children

    Directory of Open Access Journals (Sweden)

    Jablan Branka

    2012-01-01

    Full Text Available The aim of this paper is to explain the calendar systems and their role in teaching deaf-blind children. Deaf-blind persons belong to a group of multiple disabled persons. This disability should not be observed as a simple composite of visual and hearing impairments, but as a combination of sensory impairments that require special assistance in the development, communication and training for independent living. In our environment, deaf-blind children are being educated in schools for children with visual impairments or in schools for children with hearing impairments (in accordance with the primary impairment. However, deaf-blind children cannot be trained by means of special programs for children with hearing impairment, visual impairment or other programs for students with developmental disabilities without specific attention required by such a combination of sensory impairments. Deaf-blindness must be observed as a multiple impairment that requires special work methods, especially in the field of communication, whose development is severely compromised. Communication skills in deaf-blind people can be developed by using the calendar systems. They are designed in such a manner that they can be easily attainable to children with various sensory impairments. Calendars can be used to encourage and develop communication between adult persons and a deaf-blind child.

  18. Ask a Scientist: What is Color Blindness?

    Medline Plus

    Full Text Available ... color blindness, whether it can be treated, and how people become color blind. What do my eyes ... Watch What is color blindness? Click to Watch How do I become a scientist? Click to Watch ...

  19. "Is powered toothbrush better than manual toothbrush in removing dental plaque?" - A crossover randomized double-blind study among differently abled, India.

    Science.gov (United States)

    Neelima, Mallam; Chandrashekar, Byalakere Rudraiah; Goel, Shubhi; Sushma, Rudraswamy; Srilatha, Yarramasu

    2017-01-01

    Although mechanical plaque removal is an effective method, powered toothbrushes are specially designed to benefit differently abled. Literature comparing plaque removal efficacy between manual and powered toothbrushes among differently abled is sparse. A cross-over, randomized, double-blind study was conducted in differently abled institution. Twenty differently abled participants were randomly assigned to two groups of ten participants. Plaque removal efficacy of battery-operated powered toothbrush was compared with manual toothbrush in a single brushing on the 8 th day. After a washout of 1 week, groups were switched. Assessment of plaque scores was done using Turesky's modification of Quigley-Hein plaque index. Difference in plaque score between pre- and post-brushing in each group was compared using paired sample t -test. In the pooled data analysis combining the results of Phase I and II, mean pre- and post-brushing plaque scores with manual toothbrush was 2.26 ± 0.4 and 1.93 ± 0.5, respectively, while with powered toothbrush, it was 2.21 ± 0.4 and 1.96 ± 0.4, respectively. However, difference in mean plaque reduction between manual and powered toothbrushes was not significant. Manual toothbrushes were equally effective compared to powered toothbrushes. Long-term studies precisely documenting cost-effectiveness and participant perception in the ease of use are recommended to validate our results.

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

    Science.gov (United States)

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

    2017-02-01

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

  1. The effect of Korean pine nut oil (PinnoThin™ on food intake, feeding behaviour and appetite: A double-blind placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Harrold Joanne A

    2008-02-01

    Full Text Available Abstract Certain free fatty acids have been shown to have potent effects on food intake and self-reported changes in appetite; effects associated with increases in the release of endogenous cholecystokinin (CCK and glucagon like peptide-1 (GLP-1. In the current study, the effects of a Korean pine nut oil product, PinnoThin™, at doses 2 g, 4 g and 6 g triglyceride (TG and 2 g free fatty acid (FFA, on food intake and appetite were examined in a cross-over double-blind placebo-controlled randomised counter-balanced design in 42 overweight female volunteers. 2 g FFA PinnoThin™, given 30 minutes prior to an ad-libitum buffet test lunch, significantly reduced food intake (gram by 9% (F(4,164 = 2.637, p = 0.036 compared to olive oil control. No significant effect of PinnoThin™ on macronutrient intake or ratings of appetite were observed. Given the recent data showing that the TG form of PinnoThin™ may also reduce appetite by increasing CCK release, the lack of any effect of the TG form found in this study could be attributed to the timing of the dosing regime. Collectively, these data suggest that PinnoThin™ may exert satiating effects consistent with its known action on CCK and GLP-1 release, and previously observed effects on self-reported appetite ratings.

  2. Two randomized cross-over trials assessing the impact of dietary gluten or wholegrain on the gut microbiome and host metabolic health

    DEFF Research Database (Denmark)

    Ibrügger, Sabine; Gøbel, Rikke Juul; Vestergaard, Henrik

    2014-01-01

    Background: Gut microbiota composition and activity may be changed by dietary factors and possibly affect metabolic health. Dietary gluten and wholegrain are suggested to influence metabolism in a negative and positive direction, respectively. Objective: Describe the design and rational as well...... as baseline characteristics of two human intervention studies, within the Gut, Grain and Greens (3G) Center, investigating the effects of a gluten-poor and wholegrain-rich diet on microbiota composition and metabolic health. Design: The gluten and wholegrain studies had a randomized, controlled, cross...... of the wholegrain study. Further, a number of secondary outcomes were investigated. Results: 52 and 50 participants completed the gluten and wholegrain intervention study, respectively. Participants had slightly elevated fasting glucose levels and increased waist circumference. Biological outcomes of the two...

  3. Causes of visual impairment and blindness in children at Instituto Benjamin Constant Blind School, Rio de Janeiro

    Directory of Open Access Journals (Sweden)

    Daniela da Silva Verzoni

    Full Text Available Abstract Objective: To determine the main causes of visual impairment and blindness in children enrolled at Instituto Benjamin Constant blind school (IBC in 2013, to aid in planning for the prevention and management of avoidable causes of blindness. Methods: Study design: cross-sectional observational study. Data was collected from medical records of students attending IBC in 2013. Causes of blindness were classified according to WHO/PBL examination record. Data were analyzed for those children aged less than 16 years using Stata 9 program. Results: Among 355 students attending IBC in 2013, 253 (73% were included in this study. Of these children, 190 (75% were blind and 63 (25% visually impaired. The major anatomical site of visual loss was retina (42%, followed by lesions of the globe (22%, optic nerve lesions (13.8%, central nervous system (8.8% and cataract/pseudophakia/aphakia (8.8%. The etiology was unknown in 41.9% and neonatal factors accounted for 30,9% of cases. Forty-eight percent of cases were potentially avoidable. Retinopathy of prematurity (ROP was the main cause of blindness and with microphthalmia, optic nerve atrophy, cataract and glaucoma accounted for more than 50% of cases. Conclusion: Provision and improvement of ROP, cataract and glaucoma screening and treatment and programs could prevent avoidable visual impairment and blindness.

  4. Two-Year Study of Northwest Regional Center's Summer Sessions for Preschool, Rubella, Deaf-Blind Children. Final Report.

    Science.gov (United States)

    Starkovich, Paul

    The report describes the Summer Sessions for Preschool, Rubella, Deaf-Blind Children conducted in 1970 and 1971 by the Northwest Regional Center for Deaf-Blind Children in Vancouver, Washington. The summer programs were primarily designed to evaluate preschool deaf-blind children in a learning and living situation. The report is intended not only…

  5. Blind extraction of exoplanetary spectra

    Science.gov (United States)

    Morello, Giuseppe; Waldmann, Ingo; Damiano, Mario; Tinetti, Giovanna

    2016-10-01

    In the last decade, remote sensing spectroscopy enabled characterization of the atmospheres of extrasolar planets. Transmission and emission spectra of tens of transiting exoplanets have been measured with multiple instruments aboard Spitzer and Hubble Space Telescopes as well as ground-based facilities, revealing the presence of chemical species in their atmospheres, and constraining their temperature and pressure profiles.Early analyses were somehow heuristic, leading to some controversies in the literature.A photometric precision of 0.01% is necessary to detect the atmospheric spectral modulations. Current observatories, except Kepler, were not designed to achieve this precision. Data reduction is necessary to minimize the effect of instrument systematics in order to achieve the target precision. In the past, parametric models have extensively been used by most teams to remove correlated noise with the aid of auxiliary information of the instrument, the so-called optical state vectors (OSVs). Such OSVs can include inter- and intra-pixel position of the star or its spectrum, instrument temperatures and inclinations, and/or other parameters. In some cases, different parameterizations led to discrepant results.We recommend the use of blind non-parametric data detrending techniques to overcome those issues. In particular, we adopt Independent Component Analysis (ICA), i.e. a powerful blind source separation (BSS) technique to disentangle the multiple instrument systematics and astrophysical signals in transit/eclipse light curves. ICA does not require a model for the systematics, thence it can be applied to any instrument with little changes, if any. ICA-based algorithms have been applied to Spitzer/IRAC and synthetic observations in photometry (Morello et al. 2014, 2015, 2016; Morello 2015) and to Hubble/WFC3, Hubble/NICMOS and Spitzer/IRS and Hubble/WFC3 in spectroscopy (Damiano, Morello et al., in prep., Waldmann 2012, 2014, Waldmann et al. 2013) with excellent

  6. Visual impairment and blindness among the students of blind schools in Allahabad and its vicinity: A causal assessment

    Directory of Open Access Journals (Sweden)

    Sushank Ashok Bhalerao

    2015-01-01

    Full Text Available Background/Aims: Information on eye diseases in blind school children in Allahabad is rare and sketchy. A cross-sectional study was performed to identify causes of blindness (BL in blind school children with an aim to gather information on ocular morbidity in the blind schools in Allahabad and in its vicinity. Study Design and Setting: A cross-sectional study was carried out in all the four blind schools in Allahabad and its vicinity. Materials and Methods: The students in the blind schools visited were included in the study and informed consents from parents were obtained. Relevant ocular history and basic ocular examinations were carried out on the students of the blind schools. Results: A total of 90 students were examined in four schools of the blind in Allahabad and in the vicinity. The main causes of severe visual impairment and BL in the better eye of students were microphthalmos (34.44%, corneal scar (22.23%, anophthalmos (14.45%, pseudophakia (6.67%, optic nerve atrophy (6.67%, buphthalmos/glaucoma (3.33%, cryptophthalmos (2.22%, staphyloma (2.22%, cataract (2.22%, retinal dystrophy (2.22%, aphakia (1.11%, coloboma (1.11%, retinal detachment (1.11%, etc. Of these, 22 (24.44% students had preventable causes of BL and another 12 (13.33% students had treatable causes of BL. Conclusion: It was found that hereditary diseases, corneal scar, glaucoma and cataract were the prominent causes of BL among the students of blind schools. Almost 38% of the students had preventable or treatable causes, indicating the need of genetical counseling and focused intervention.

  7. AudioMUD: a multiuser virtual environment for blind people.

    Science.gov (United States)

    Sánchez, Jaime; Hassler, Tiago

    2007-03-01

    A number of virtual environments have been developed during the last years. Among them there are some applications for blind people based on different type of audio, from simple sounds to 3-D audio. In this study, we pursued a different approach. We designed AudioMUD by using spoken text to describe the environment, navigation, and interaction. We have also introduced some collaborative features into the interaction between blind users. The core of a multiuser MUD game is a networked textual virtual environment. We developed AudioMUD by adding some collaborative features to the basic idea of a MUD and placed a simulated virtual environment inside the human body. This paper presents the design and usability evaluation of AudioMUD. Blind learners were motivated when interacted with AudioMUD and helped to improve the interaction through audio and interface design elements.

  8. Racismo como verbalismo? Delineamentos para compreensão da aquisição do racismo entre cegos congênitos Racism as verbalism? Designs for understanding the acquisition of racismo among congenitally blind

    Directory of Open Access Journals (Sweden)

    Sandra Leal de Melo Dahia

    2013-01-01

    Full Text Available O artigo discute a questão da aquisição do racismo e do preconceito racial em crianças cegas congênitas. Está parcialmente fundamentado na perspectiva do antropólogo Lawrence A. Hirschfeld, estudioso da dimensão cultural da vida mental, pela ênfase que confere à linguagem na formação de conceitos raciais, em detrimento de indicadores visuais. O cerne do artigo reside em considerar algumas possibilidades alternativas para a construção de conceitos raciais e para a vivência do fenômeno do racismo que ora apontam para um padrão próprio aos cegos, ora apontam para um padrão semelhante ao dos videntes ou, ainda, para o mero artificialismo na vivência do racismo. Para esta alternativa, torna pertinente a introdução de uma discussão sobre relações de poder entre cegos e videntes numa sociedade visual, onde se observa que as condições sociais influenciam significativamente. O verbalismo se constitui num processo que parece acentuar a condição de subordinação dos cegos.This article discusses the issue of the acquisition of racism and racial prejudice in children with congenital blindness.This study was partially based on the perspective of the viewpoint of the anthropologist Lawrence A. Hirschfeld, who has researched cultural dimension of the mental life through emphasis on the role of language on the development of racial concepts, at the expense of visual indicators. The core of the study stands on considering alternative possibilities for shaping racial concepts and experiencing racism which, which at times suggest a pattern unique to the blind and, at others, one similar to the sighted, and yet occasionally evoke the mere artificiality of the experience of racism.Under this premise, the article finds it pertinent to introduce a discussion about power relations between the blind and the sighted in a visual society, whereby the social context associated with blindness significantly influences. Verbalism becomes thus a

  9. American Foundation for the Blind

    Science.gov (United States)

    ... and Electronic Materials Webinars and Online Courses Accessible Technology AccessWorld ® : Technology News for People Who Are Blind ... Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma ...

  10. Simple pendulum for blind students

    Science.gov (United States)

    Goncalves, A. M. B.; Cena, C. R.; Alves, D. C. B.; Errobidart, N. C. G.; Jardim, M. I. A.; Queiros, W. P.

    2017-09-01

    Faced with the need to teach physics to the visually impaired, in this paper we propose a way to demonstrate the dependence of distance and time in a pendulum experiment to blind students. The periodic oscillation of the pendulum is translated, by an Arduino and an ultrasonic sensor, in a periodic variation of frequency in a speaker. The main advantage of this proposal is the possibility that a blind student understands the movement without necessity of touching it.

  11. Protein from meat or vegetable sources in meals matched for fiber content has similar effects on subjective appetite sensations and energy intake - A randomized acute cross-over meal test study

    DEFF Research Database (Denmark)

    Nielsen, Lone Vestergaard; Kristensen, Marlene D; Klingenberg, Lars

    2018-01-01

    intake and appetite sensations, compared to macronutrient-balanced, iso-caloric meals based on animal protein (veal/pork or eggs). Thirty-five healthy men were enrolled in this acute cross-over study. On each test day, participants were presented with one of four test meals (~3550 kilojoules (kJ) 19...... libitum meal three hours later. There were no differences in ad libitum energy intake across test meals (p > 0.05). Further, no differences were found across meals for hunger, satiety, fullness, prospective food consumption, or composite appetite score (all p > 0.05). Iso-caloric, macronutrient...

  12. Design

    DEFF Research Database (Denmark)

    Jensen, Ole B.; Pettiway, Keon

    2017-01-01

    by designers, planners, etc. (staging from above) and mobile subjects (staging from below). A research agenda for studying situated practices of mobility and mobilities design is outlined in three directions: foci of studies, methods and approaches, and epistemologies and frames of thinking. Jensen begins......In this chapter, Ole B. Jensen takes a situational approach to mobilities to examine how ordinary life activities are structured by technology and design. Using “staging mobilities” as a theoretical approach, Jensen considers mobilities as overlapping, actions, interactions and decisions...... with a brief description of how movement is studied within social sciences after the “mobilities turn” versus the idea of physical movement in transport geography and engineering. He then explains how “mobilities design” was derived from connections between traffic and architecture. Jensen concludes...

  13. Concept mapping for virtual rehabilitation and training of the blind.

    Science.gov (United States)

    Sanchez, Jaime; Flores, Hector

    2010-04-01

    Concept mapping is a technique that allows for the strengthening of the learning process, based on graphic representations of the learner's mental schemes. However, due to its graphic nature, it cannot be utilized by learners with visual disabilities. In response to this limitation we implemented a study that involves the design of AudiodMC, an audio-based, virtual environment for concept mapping designed for use by blind users and aimed at virtual training and rehabilitation. We analyzed the stages involved in the design of AudiodMC from a user-centered design perspective, considering user involvement and usability testing. These include an observation stage to learn how blind learners construct conceptual maps using concrete materials, a design stage to design of a software tool that aids blind users in creating concept maps, and a cognitive evaluation stage using AudiodMC. We also present the results of a study implemented in order to determine the impact of the use of this software on the development of essential skills for concept mapping (association, classification, categorization, sorting and summarizing). The results point to a high level of user acceptance, having identified key sound characteristics that help blind learners to learn concept codification and selection skills. The use of AudiodMC also allowed for the effective development of the skills under review in our research, thus facilitating meaningful learning.

  14. Psychologica and social adjustment to blindness: Understanding ...

    African Journals Online (AJOL)

    Psychologica and social adjustment to blindness: Understanding from two groups of blind people in Ilorin, Nigeria. ... Background: Blindness can cause psychosocial distress leading to maladjustment if not mitigated. Maladjustment is a secondary burden that further reduces quality of life of the blind. Adjustment is often ...

  15. Design

    DEFF Research Database (Denmark)

    Volf, Mette

    Design - proces & metode iBog®  er enestående i sit fokus på afmystificering og operationalisering af designprocessens flygtige og komplekse karakter. Udgivelsen går bag om designerens daglige arbejde og giver et indblik i den kreative skabelsesproces, som designeren er en del af. Udover et bredt...... indblik i designerens arbejdsmetoder og designparametre giver Design - proces & metode en række eksempler fra anerkendte designvirksomheder, der gør det muligt at komme helt tæt på designerens virkelighed....

  16. Effects of a mixed berry beverage on cognitive functions and cardiometabolic risk markers; A randomized cross-over study in healthy older adults.

    Directory of Open Access Journals (Sweden)

    Anne Nilsson

    Full Text Available Berries and associated bioactive compounds, e.g. polyphenols and dietary fibre (DF, may have beneficial implications with respect to the metabolic syndrome, including also cognitive functions. The aim of this study was to evaluate effects on cognitive functions and cardiometabolic risk markers of 5 wk intervention with a mixture of berries, in healthy humans.Forty healthy subjects between 50-70 years old were provided a berry beverage based on a mixture of berries (150g blueberries, 50g blackcurrant, 50g elderberry, 50g lingonberries, 50g strawberry, and 100g tomatoes or a control beverage, daily during 5 weeks in a randomized crossover design. The control beverage (water based was matched with respect to monosaccharides, pH, and volume. Cognitive tests included tests of working memory capacity, selective attention, and psychomotor reaction time. Cardiometabolic test variables investigated were blood pressure, fasting blood concentrations of glucose, insulin, blood lipids, inflammatory markers, and markers of oxidative stress.The daily amounts of total polyphenols and DF from the berry beverage were 795 mg and 11g, respectively. There were no polyphenols or DF in the control beverage. The berry intervention reduced total- and LDL cholesterol compared to baseline (both P<0.05, and in comparison to the control beverage (P<0.005 and P<0.01, respectively. The control beverage increased glucose concentrations (P<0.01 and tended to increase insulin concentrations (P = 0.064 from base line, and increased insulin concentrations in comparison to the berry beverage (P<0.05. Subjects performed better in the working memory test after the berry beverage compared to after the control beverage (P<0.05. No significant effects on the other test variables were observed.The improvements in cardiometabolic risk markers and cognitive performance after the berry beverage suggest preventive potential of berries with respect to type 2 diabetes, cardiovascular disease

  17. Effects of a brown beans evening meal on metabolic risk markers and appetite regulating hormones at a subsequent standardized breakfast: a randomized cross-over study.

    Directory of Open Access Journals (Sweden)

    Anne Nilsson

    Full Text Available BACKGROUND: Dietary prevention strategies are increasingly recognized as essential to combat the current epidemic of obesity and related metabolic disorders. The purpose of the present study was to evaluate the potential prebiotic effects of indigestible carbohydrates in Swedish brown beans (Phaseolus vulgaris var. nanus in relation to cardiometabolic risk markers and appetite regulating hormones. METHODS: Brown beans, or white wheat bread (WWB, reference product were provided as evening meals to 16 healthy young adults in a randomised crossover design. Glucose, insulin, appetite regulatory hormones, GLP-1, GLP-2, appetite sensations, and markers of inflammation were measured at a following standardised breakfast, that is at 11 to 14 h post the evening meals. Additionally, colonic fermentation activity was estimated from measurement of plasma short chain fatty acids (SCFA, including also branched chain fatty acids and breath hydrogen (H2 excretion. RESULTS: An evening meal of brown beans, in comparison with WWB, lowered blood glucose (-15%, p<0.01- and insulin (-16%, p<0.05 responses, increased satiety hormones (PYY 51%, p<0.001, suppressed hunger hormones (ghrelin -14%, p<0.05, and hunger sensations (-15%, p = 0.05, increased GLP-2 concentrations (8.4%, p<0.05 and suppressed inflammatory markers (IL-6 -35%, and IL-18 -8.3%, p<0.05 at a subsequent standardised breakfast. Breath H2 (141%, p<0.01, propionate (16%, p<0.05, and isobutyrate (18%, P<0.001 were significantly increased after brown beans compared to after WWB, indicating a higher colonic fermentative activity after brown beans. CONCLUSIONS: An evening meal with brown beans beneficially affected important measures of cardiometabolic risk and appetite regulatory hormones, within a time frame of 11-14 h, in comparison to a WWB evening meal. Concentrations of plasma SCFA and H2 were increased, indicating involvement of colonic fermentation. Indigestible colonic substrates from brown

  18. Design

    Science.gov (United States)

    Buchanan, Richard; Cross, Nigel; Durling, David; Nelson, Harold; Owen, Charles; Valtonen, Anna; Boling, Elizabeth; Gibbons, Andrew; Visscher-Voerman, Irene

    2013-01-01

    Scholars representing the field of design were asked to identify what they considered to be the most exciting and imaginative work currently being done in their field, as well as how that work might change our understanding. The scholars included Richard Buchanan, Nigel Cross, David Durling, Harold Nelson, Charles Owen, and Anna Valtonen. Scholars…

  19. Design

    DEFF Research Database (Denmark)

    Jensen, Ole B.; Pettiway, Keon

    2017-01-01

    In this chapter, Ole B. Jensen takes a situational approach to mobilities to examine how ordinary life activities are structured by technology and design. Using “staging mobilities” as a theoretical approach, Jensen considers mobilities as overlapping, actions, interactions and decisions by desig......In this chapter, Ole B. Jensen takes a situational approach to mobilities to examine how ordinary life activities are structured by technology and design. Using “staging mobilities” as a theoretical approach, Jensen considers mobilities as overlapping, actions, interactions and decisions...... by designers, planners, etc. (staging from above) and mobile subjects (staging from below). A research agenda for studying situated practices of mobility and mobilities design is outlined in three directions: foci of studies, methods and approaches, and epistemologies and frames of thinking. Jensen begins...... with a brief description of how movement is studied within social sciences after the “mobilities turn” versus the idea of physical movement in transport geography and engineering. He then explains how “mobilities design” was derived from connections between traffic and architecture. Jensen concludes...

  20. Causes of blindness in blind unit of the school for the handicapped ...

    African Journals Online (AJOL)

    To describe the causes of blindness in pupils and staff in the blind unit of the School for the Handicapped in Kwara State. 2. To identify problems in the blind school and initiate intervention. All the blind or visually challenged people in the blind unit of the school for the handicapped were interviewed and examined using a ...

  1. Indoor orientation and mobility for learners who are blind.

    Science.gov (United States)

    Sáenz, Mauricio; Sánchez, Jaime

    2010-01-01

    This study consisted of designing a mobile technology to identify the position and orientation of people who are blind in closed environments, such as a school, building or home, identifying the necessary infrastructure based on criteria of usability, reliability and accessibility, in order for PocketPC device interface developers to be able to define the technology to be used at an early stage. The technology consisted of using PocketPC devices with a data collecting application and another for the representation of space. We evaluated its usability, accessibility, reliability, efficiency, and availability. The results of the usability evaluation assured us that the interface designed and developed is usable for users who are blind, which is reaffirmed through the accessibility evaluation. The reliability, efficiency and availability evaluations of the system show that a user who is blind can use the system confidently, because it provides correct information for more independent navigation.

  2. Future trends in global blindness

    Directory of Open Access Journals (Sweden)

    Serge Resnikoff

    2012-01-01

    Full Text Available The objective of this review is to discuss the available data on the prevalence and causes of global blindness, and some of the associated trends and limitations seen. A literature search was conducted using the terms "global AND blindness" and "global AND vision AND impairment", resulting in seven appropriate articles for this review. Since 1990 the estimate of global prevalence of blindness has gradually decreased when considering the best corrected visual acuity definition: 0.71% in 1990, 0.59% in 2002, and 0.55% in 2010, corresponding to a 0.73% reduction per year over the 2002-2010 period. Significant limitations were found in the comparability between the global estimates in prevalence or causes of blindness or visual impairment. These limitations arise from various factors such as uncertainties about the true cause of the impairment, the use of different definitions and methods, and the absence of data from a number of geographical areas, leading to various extrapolation methods, which in turn seriously limit comparability. Seminal to this discussion on limitations in the comparability of studies and data, is that blindness has historically been defined using best corrected visual acuity.

  3. FLIPPS for the Blind

    DEFF Research Database (Denmark)

    Bothe, Hans-Heinrich; Al-Hamdani, Sermed

    2010-01-01

    The idea of FLIPPS is to design, implement, and evaluate a vibro-tactile device that is composed of a photo diode, vibro-tactile stimulator, microcontroller and power supply. The stimulator is attached to the finger tip and activated when light illumination exceeds a defined threshold. The subject...

  4. The 2013 National Child Count of Children and Youth Who Are Deaf-Blind

    Science.gov (United States)

    National Center on Deaf-Blindness, 2014

    2014-01-01

    The National Child Count of Children and Youth who are Deaf-Blind is the first and longest running registry and knowledge base of children who are deaf-blind in the world. It has been collaboratively designed, implemented and revised to serve as the common vehicle to meet federal grant requirements for both the State/Multi-State and National…

  5. A Description of a Blind Student's Science Process Skills through Health Physics

    Science.gov (United States)

    Bülbül, M. Sahin

    2013-01-01

    This study describes an approach for blind students thought health physics about how they could set a hypothesis and test it. The participant of the study used some health materials designed for high school blind student and tested her hypothesis with the data she gathered with those materials. It was asked that she should hypothesize which could…

  6. Moblogging Type and Its Relation with Usability and Development of Knowledge Management Skills for Blind Students

    Science.gov (United States)

    Mostafa, Akram Fathy

    2015-01-01

    The aim of the research is to explore the relation of mobile Blogging (Moblogging -MB) on the usability and development of Knowledge Management skills for Blind Students. The research followed a pretest and posttest quasi experimental design. Participants were 17 blind students from the third semester of the academic year 2015 in the course of…

  7. Comparing Whole Building Energy Implications of Sidelighting Systems with Alternate Manual Blind Control Algorithms

    Directory of Open Access Journals (Sweden)

    Christopher Dyke

    2015-05-01

    Full Text Available Currently, there is no manual blind control guideline used consistently throughout the energy modeling community. This paper identifies and compares five manual blind control algorithms with unique control patterns and reports blind occlusion, rate of change data, and annual building energy consumption. The blind control schemes detailed here represent five reasonable candidates for use in lighting and energy simulation based on difference driving factors. This study was performed on a medium-sized office building using EnergyPlus with the internal daylight harvesting engine. Results show that applying manual blind control algorithms affects the total annual consumption of the building by as much as 12.5% and 11.5% for interior and exterior blinds respectively, compared to the Always Retracted blinds algorithm. Peak demand was also compared showing blind algorithms affected zone load sizing by as much as 9.8%. The alternate algorithms were tested for their impact on American Society of Heating, Refrigeration and Air-Conditioning Engineers (ASHRAE Guideline 14 calibration metrics and all models were found to differ from the original calibrated baseline by more than the recommended ±15% for coefficient of variance of the mean square error (CVRMSE and ±5% for normalized mean bias error (NMBE. The paper recommends that energy modelers use one or more manual blind control algorithms during design stages when making decisions about energy efficiency and other design alternatives.

  8. Epidemiology of blindness in children.

    Science.gov (United States)

    Solebo, Ameenat Lola; Teoh, Lucinda; Rahi, Jugnoo

    2017-09-01

    An estimated 14 million of the world's children are blind. A blind child is more likely to live in socioeconomic deprivation, to be more frequently hospitalised during childhood and to die in childhood than a child not living with blindness. This update of a previous review on childhood visual impairment focuses on emerging therapies for children with severe visual disability (severe visual impairment and blindness or SVI/BL).For children in higher income countries, cerebral visual impairment and optic nerve anomalies remain the most common causes of SVI/BL, while retinopathy of prematurity (ROP) and cataract are now the most common avoidable causes. The constellation of causes of childhood blindness in lower income settings is shifting from infective and nutritional corneal opacities and congenital anomalies to more resemble the patterns seen in higher income settings. Improvements in maternal and neonatal health and investment in and maintenance of national ophthalmic care infrastructure are the key to reducing the burden of avoidable blindness. New therapeutic targets are emerging for childhood visual disorders, although the safety and efficacy of novel therapies for diseases such as ROP or retinal dystrophies are not yet clear. Population-based epidemiological research, particularly on cerebral visual impairment and optic nerve hypoplasia, is needed in order to improve understanding of risk factors and to inform and support the development of novel therapies for disorders currently considered 'untreatable'. © 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.

  9. Crossing over; taking refuge: A contrapuntal reading

    Directory of Open Access Journals (Sweden)

    Elaine M. Wainwright

    2014-11-01

    Full Text Available In this article, I undertake a contrapuntal reading (a type of reading developed within post-colonial studies engaging the Gospel of Matthew and the current global and local contexts of migration. The work demonstrates the mode and the significance of such readings and ways in which the approach could be brought to bear in a range of contemporary contexts and in relation to any number of current global and local issues.

  10. Double blind clinical trail comparing the safety and efficacy of ...

    African Journals Online (AJOL)

    Background: Osteoarthritis of the hip or knees is a very disabling condition in both Caucasians and Africans. A lot of medical drugs have been in use with their corresponding side effects, hence the search for newer drugs with fewer side effects. Study design: A double blind clinical trial comparing the safety and efficacy of ...

  11. The Indiana Deaf-Blind Services Project. Final Performance Report.

    Science.gov (United States)

    Goehl, Karen S.

    This final report describes activities and accomplishments of the Indiana Deaf-Blind Services Project, a 3-year federally funded project to enhance and further develop coordinated direct services to children and youth, birth through age 2 and ages 18 through 21. It also was designed to provide technical assistance to public and private agencies…

  12. The effect of small solar powered 'Bͻkͻͻ' net fans on mosquito net use: results from a randomized controlled cross-over trial in southern Ghana.

    Science.gov (United States)

    Briët, Olivier J T; Yukich, Joshua O; Pfeiffer, Constanze; Miller, William; Jaeger, Mulako S; Khanna, Nitin; Oppong, Samuel; Nardini, Peter; Ahorlu, Collins K; Keating, Joseph

    2017-01-03

    Long-lasting insecticidal nets (LLINs) are ineffective malaria transmission prevention tools if they are unused. Discomfort due to heat is the most commonly reported reason for not using nets, but this problem is largely unaddressed. With increasing rural electrification and the dropping price of solar power, fans could improve comfort inside nets and be affordable to populations in malaria endemic areas. Here, results are presented from a pilot randomized controlled cross-over study testing the effect of fans on LLIN use. Eighty-three households from two rural communities in Greater Accra, Ghana, randomized into three groups, participated in a 10-month cross-over trial. After a screening survey to identify eligible households, all households received new LLINs. Bͻkͻͻ net fan systems (one fan per member) were given to households in Group 1 and water filters were given to households in Group 2. At mid-point, Group 1 and 2 crossed over interventions. Households in Group 1 and 2 participated in fortnightly surveys on households' practices related to nets, fans and water filters, while households in Group 3 were surveyed only at screening, mid-point and study end. Entomological and weather data were collected throughout the study. Analysis took both 'per protocol' (PP) and 'intention to treat' (ITT) approaches. The mid- and end-point survey data from Group 1 and 2 were analysed using Firth logistic regressions. Fortnightly survey data from all groups were analysed using logistic regressions with random effects. Provision of fans to households appeared to increase net use in this study. Although the increase in net use explained by fans was not significant in the primary analyses (ITT odds ratio 3.24, p > 0.01; PP odds ratio = 1.17, p > 0.01), it was significant in secondary PP analysis (odds ratio = 1.95, p Fan use was 90-100% depending on the fortnightly visit. This pilot study could not provide definitive evidence that fans increase net use. A larger

  13. Arsanilic acid blindness in pigs

    Energy Technology Data Exchange (ETDEWEB)

    Menges, R.W.; Kintner, L.D.; Selby, L.A.; Stewart, R.W.; Marlenfeld, C.J.

    1970-06-01

    Blindness in pigs that were given an overdosage of arsanilic acid is reported. A 0.0375% level of arsanilic acid was fed to 640 pigs for 90 days beginning when the animals were 3 months old. Approximately one month after the start of feeding, partial or complete blindness was observed in 50 of the pigs. Clinical signs, pathologic findings and the chemical analysis of hair are discussed. The level of arsanilic acid used was that recommended for the control of swine dysentery, to be fed for only five or six days. The overdosage resulted from a misunderstanding between the farmer and the feed mill.

  14. Sound lateralization test in adolescent blind individuals.

    Science.gov (United States)

    Yabe, Takao; Kaga, Kimitaka

    2005-06-21

    Blind individuals require to compensate for the lack of visual information by other sensory inputs. In particular, auditory inputs are crucial to such individuals. To investigate whether blind individuals localize sound in space better than sighted individuals, we tested the auditory ability of adolescent blind individuals using a sound lateralization method. The interaural time difference discrimination thresholds of blind individuals were statistically significantly shorter than those of blind individuals with residual vision and controls. These findings suggest that blind individuals have better auditory spatial ability than individuals with visual cues; therefore, some perceptual compensation occurred in the former.

  15. Long-term effects of vitamin D supplementation in vitamin D deficient obese children participating in an integrated weight-loss programme (a double-blind placebo-controlled study) - rationale for the study design.

    Science.gov (United States)

    Szlagatys-Sidorkiewicz, Agnieszka; Brzeziński, Michał; Jankowska, Agnieszka; Metelska, Paulina; Słomińska-Frączek, Magdalena; Socha, Piotr

    2017-04-04

    Obesity is associated not only with an array of metabolic disorders (e.g. insulin resistance, hiperinsulinemia, impaired tolerance of glucose, lipid disorders) but also skeletal and joint abnormalities. Recently, a pleiotropic role of vitamin D has been emphasized. Obese children frequently present with vitamin D deficiency, and greater fat mass is associated with lower serum concentration of this vitamin. Although some evidence suggests that weight loss may affect vitamin D status, this issue has not been studied extensively thus far. The aim of a double-blind placebo-controlled study is to assess long-term health effects of vitamin D supplementation in vitamin D deficient obese children participating in an integrated weight-loss programme. A randomized double-blind, placebo-controlled trial analysing the effects of vitamin D3 supplementation in overweight or obese vitamin D deficient (vitamin D (1200 IU) or placebo for 26 weeks. Primary endpoints include changes in BMI (body mass index), body composition and bone mineral density at the end of the study period, and secondary endpoints - the changes in laboratory parameter reflecting liver and kidney function (transaminases, creatinine) and glucose homeostasis (glucose and insulin levels during oral glucose tolerance test). The effects of vitamin D supplementation in obese individuals, especially children, subjected to a weight-loss program are still poorly understood. Considering physiological processes associated with puberty and adolescent growth, we speculate that supplementation may enhance weight reduction and prevent bone loss in obese children deficient in this vitamin. NCT 02828228 ; Trial registration date: 8 Jun 2016; Registered in: ClinicalTrials.gov. The trial was registered retrospectively.

  16. The effects of Nordic school meals on concentration and school performance in 8- to 11-year-old children in the OPUS School Meal Study: a cluster-randomised, controlled, cross-over trial

    DEFF Research Database (Denmark)

    Sørensen, Louise B.; Dyssegaard, Camilla B.; Damsgaard, Camilla T.

    2015-01-01

    . The OPUS (Optimal well-being, development and health for Danish children through a healthy New Nordic Diet) School Meal Study was a cluster-randomised, controlled, cross-over trial comparing a healthy school meal programme with the usual packed lunch from home (control) each for 3 months (NCT 01457794......It is widely assumed that nutrition can improve school performance in children; however, evidence remains limited and inconclusive. In the present study, we investigated whether serving healthy school meals influenced concentration and school performance of 8- to 11-year-old Danish children......). The d2 test of attention, the Learning Rating Scale (LRS) and standard tests on reading and mathematics proficiency were administered at baseline and at the end of each study period. Intervention effects were evaluated using hierarchical mixed models. The school meal intervention did not influence...

  17. Causes of childhood blindness in the northeastern states of India

    Directory of Open Access Journals (Sweden)

    Bhattacharjee Harsha

    2008-01-01

    Full Text Available Background: The northeastern region (NER of India is geographically isolated and ethno-culturally different from the rest of the country. There is lacuna regarding the data on causes of blindness and severe visual impairment in children from this region. Aim: To determine the causes of severe visual impairment and blindness amongst children from schools for the blind in the four states of NER of India. Design and Setting: Survey of children attending special education schools for the blind in the NER. Materials and Methods: Blind and severely visually impaired children (best corrected visual acuity < 20/200 in the better eye, aged up to 16 years underwent visual acuity estimation, external ocular examination, retinoscopy and fundoscopy. Refraction and low vision workup was done where indicated. World Health Organization′s reporting form was used to code anatomical and etiological causes of visual loss. Statistical Analysis: Microsoft Excel Windows software with SPSS. Results: A total of 376 students were examined of whom 258 fulfilled the eligibility criteria. The major anatomical causes of visual loss amongst the 258 were congenital anomalies (anophthalmos, microphthalmos 93 (36.1%; corneal conditions (scarring, vitamin A deficiency 94 (36.7%; cataract or aphakia 28 (10.9%, retinal disorders 15 (5.8% and optic atrophy 14 (5.3%. Nearly half of the children were blind from conditions which were either preventable or treatable (48.5%. Conclusion: Nearly half the childhood blindness in the NER states of India is avoidable and Vitamin A deficiency forms an important component unlike other Indian states. More research and multisectorial effort is needed to tackle congenital anomalies.

  18. Distinct difference in relative biological effectiveness of 252Cf neutrons for the induction of mitotic crossing over and intragenic reversion of the white-ivory allele in Drosophila melanogaster

    International Nuclear Information System (INIS)

    Yoshikawa, Isao; Hoshi, Masaharu; Ikenaga, Mituo

    1996-01-01

    The relative biological effectiveness (RBE) of 252 Cf neutrons was determined for two different types of somatic mutations, i.e., loss of heterozygosity for wing-hair mutations and reversion of the mutant white-ivory eye-color, in Drosophila melanogaster. Loss of heterozygosity for wing-hair mutations results predominantly from mitotic crossing over induced in wing anlage cells of larvae, while the reverse mutation of eye-color is due to an intragenic structural change in the white locus on the X-chromosome. For a quantitative comparison of RBE values for these events, we have constructed a combined mutation assay system so that induced mutant wing-hair clones as well as revertant eye-color clones can be detected simultaneously in the same individuals. Larvae were irradiated at the age of 80±4 h post-oviposition