WorldWideScience

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

    Directory of Open Access Journals (Sweden)

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

  5. Safety of a New Compact Male Intermittent Catheter: Randomized, Cross-Over, Single-Blind Study in Healthy Male Volunteers

    DEFF Research Database (Denmark)

    Bagi, Per; Hannibalsen, Jane; Permild, Rikke

    2011-01-01

    in hematuria (p = 0.54) or discomfort/stinging/pain at first micturition (p = 0.56). During insertion, handling was easier (p = 0.0001) and touching the coating was necessary less often (2.2 vs. 81.3% of catheterizations; p catheter; it was preferred by nurses for 20 of 23......Introduction: A new compact male intermittent catheter was compared with a regular intermittent male catheter in terms of safety and acceptability. Methods: In this randomized, single-blind, cross-over study, healthy male volunteers were catheterized twice with a compact catheter and twice...... with a regular catheter. Results: 28 participants were enrolled. Mean ± SD discomfort (visual analogue scale; primary objective) was 2.25 ± 1.5 and 2.52 ± 1.8 for the compact and regular catheters, respectively (difference -0.27; 95% confidence interval -0.73 to 0.19); there was no significant difference...

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    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

  9. Venlafaxine versus clonidine for the treatment of hot flashes in breast cancer patients : a double-blind, randomized cross-over study

    NARCIS (Netherlands)

    Buijs, Ciska; Mom, Constantijne H.; Willemse, Pax H. B.; Boezen, H. Marike; Maurer, J. Marina; Wymenga, A. N. Machteld; de Jong, Robert S.; Nieboer, Peter; de Vries, Elisabeth G. E.; Mourits, Marian J. E.

    Purpose Breast cancer patients with treatment-induced menopause experience frequent and severe hot flashes (HF). We compared venlafaxine and clonidine for the treatment of HF with regard to side effects, efficacy, quality of life and sexual functioning. Methods In a double-blind, cross-over study,

  10. 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...

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

    Directory of Open Access Journals (Sweden)

    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

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

    Science.gov (United States)

    Freis, Tanja; Hecksteden, Anne; Such, Ulf; Meyer, Tim

    2017-01-01

    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

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

    Science.gov (United States)

    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 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.

  14. A double-blind randomised cross-over comparison of nabilone and metoclopramide in the control of radiation-induced nausea

    International Nuclear Information System (INIS)

    Priestman, S.G.; Priestman, T.J.; Canney, P.A.

    1987-01-01

    Forty patients who were suffering from radiation induced emesis were entered into a prospectively randomised double-blind cross-over study comparing nabilone with metoclopramide. Only patients who had at least five treatments remaining of their planned course of irradiation were randomised, in order to allow an adequate time to monitor the degree of symptom control and any adverse effects of the two drugs. Patient characteristics and the incidence and severity of nausea and vomiting were similar for the two groups. There was no difference in the efficacy of the two drugs but the incidence and severity of adverse reactions was significantly greater in those patients who received nabilone. (author)

  15. 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)

    2010-01-01

    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. Discussion If our results show

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

    Directory of Open Access Journals (Sweden)

    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

  17. [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

  18. A randomized double-blind, placebo-controlled, cross-over trial (Vestparoxy) of the treatment of vestibular paroxysmia with oxcarbazepine.

    Science.gov (United States)

    Bayer, Otmar; Brémová, Tatiana; Strupp, Michael; Hüfner, Katharina

    2018-02-01

    Vestibular paroxysmia (VP) is characterized by short, often oligosymptomatic attacks of vertigo which occur spontaneously or are sometimes provoked by turning the head. Despite the description of the disease almost 40 years ago (first termed "disabling positional vertigo"), no controlled treatment trial has been published to date. The Vestparoxy trial was designed as a randomized, placebo-controlled, double-blind cross-over trial to examine the therapeutic effect of oxcarbazepine (OXA) in patients with definite or probable VP. Patients were recruited from August 2005 to December 2011 in the outpatient Dizziness Unit of the Department of Neurology of the Munich University Hospital, and randomized to receive OXA (first week: 300 mg once per day, second week: 300 mg b.i.d., third week: 300 mg t.i.d. until the end of the third month), followed by placebo or vice versa with a 1-month wash-out period in between. The primary endpoint was the number of days with one or more attacks. Secondary endpoints were the number of attacks during the observed days, and the median (for each day) duration of attacks. All these endpoints were assessed using standardized diaries collected at the end of each treatment phase. Forty-three patients were randomized, 18 patients provided usable data (2525 patient days) for at least one treatment phase and were included in the main (intention-to-treat) analysis. The most common reasons for discontinuation documented were adverse events. The risk of experiencing a day with at least one attack was 0.41 under OXA, and 0.62 under placebo treatment, yielding a relative risk of 0.67 (95% CI 0.47-0.95, p = 0.025). The number of attacks during the observed days ratio was 0.53 (95% CI 0.42-0.68, p effects.

  19. Co-ingestion of carbohydrate and whey protein isolates enhance PGC-1α mRNA expression: a randomised, single blind, cross over study

    Directory of Open Access Journals (Sweden)

    Hill Karen M

    2013-02-01

    Full Text Available Abstract Background Whey protein isolates (WPI supplementation is known to improve resistance training adaptations. However, limited information is available on the effects of WPI plus carbohydrate (CHO supplementation on endurance training adaptations. Method Six endurance trained male cyclists and triathletes (age 29 ± 4 years, weight 74 ± 2 kg, VO2 max 63 ± 3 ml oxygen. kg-1. Min-1, height 183 ± 5 cm; mean ± SEM were randomly assigned to one of two dietary interventions in a single blind cross over design; CHO or CHO + WPI. Each dietary intervention was followed for 16 days which included the last 2 days having increased CHO content, representing a CHO loading phase. The dietary interventions were iso-caloric and carbohydrate content matched. On completion of the dietary intervention, participants performed an exercise bout, consisting of cycling for 60 min at 70% VO2 max, followed by time trial to exhaustion at 90% VO2 max and recovered in the laboratory for 6 hours. Blood samples and muscle biopsies were taken at various time points at rest and through the exercise trial and recovery. Results Compared to CHO, CHO + WPI increased plasma insulin during recovery at 180 mins (P Conclusion This study showed co-ingestion of CHO + WPI may have beneficial effects on recovery and adaptations to endurance exercise via, increased insulin response and up regulation of PGC-1α mRNA expression.

  20. 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.

  1. 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...... and were randomized to receive one capsule of placebo and then caffeine (6 mg/kg) or caffeine and then placebo with 1 wk in between. One hour after intervention, we measured reaction and movement times, postural stability, walking speed, cycling at 65% of expected maximal heart rate, perceived effort...... during cycling, maximal isometric arm flexion strength, and endurance. Analysis was by intention to treat, and P Caffeine increased cycling endurance by 25% [95% confidence interval (CI): 13–38; P = 0.0001] and isometric arm flexion endurance by 54% (95% CI: 29–83; P...

  2. 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.

  3. 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

  4. 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.

  5. Prevention of head louse infestation: a randomised, double-blind, cross-over study of a novel concept product, 1% 1,2-octanediol spray versus placebo.

    Science.gov (United States)

    Burgess, Ian F; Brunton, Elizabeth R; French, Rebecca; Burgess, Nazma A; Lee, Peter N

    2014-05-30

    To determine whether regular use of a spray containing 1,2-octanediol 1%, which has been shown to inhibit survival of head lice, is able to work as a preventive against establishment of new infestations. Randomised, double-blind, cross-over, community study in Cambridgeshire, UK. 63 male and female schoolchildren aged 4-16 years judged to have a high risk of recurrent infestation. Only the youngest member of a household attending school participated. Participants were treated to eliminate lice, randomised between 1% octanediol or placebo sprays for 6 weeks then crossed-over to the other spray for 6 weeks. Parents applied the sprays at least twice weekly or more frequently if the hair was washed. Investigators monitored weekly for infestation and replenished supplies of spray. The primary endpoint was the time taken until the first infestation event occurred. The secondary measure was safety of the product in regular use. Intention-to-treat analysis found a total of 32 confirmed infestations in 20 participants, with 9 of them infested while using both products. In these nine participants the time to first infestation showed a significant advantage to 1% octanediol (p=0.0129). Per-protocol analysis showed only trends because the population included was not large enough to demonstrate significance. There were no serious adverse events and only two adverse events possibly related to treatment, one was a case of transient erythema and another of a rash that resolved after 5 days. Routine use of 1% octanediol spray provided a significant level of protection from infestation. It was concluded that this product is effective if applied regularly and thoroughly. ISRCTN09524995. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  6. 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.

  7. Evaluating brief motivational and self-regulatory hand hygiene interventions: a cross-over longitudinal design.

    Science.gov (United States)

    Lhakhang, Pempa; Lippke, Sonia; Knoll, Nina; Schwarzer, Ralf

    2015-02-04

    Frequent handwashing can prevent infections, but non-compliance to hand hygiene is pervasive. Few theory- and evidence-based interventions to improve regular handwashing are available. Therefore, two intervention modules, a motivational and a self-regulatory one, were designed and evaluated. In a longitudinal study, 205 young adults, aged 18 to 26 years, were randomized into two intervention groups. The Mot-SelfR group received first a motivational intervention (Mot; risk perception and outcome expectancies) followed by a self-regulatory intervention (SelfR; perceived self-efficacy and planning) 17 days later. The SelfR-Mot group received the same two intervention modules in the opposite order. Follow-up data were assessed 17 and 34 days after the baseline. Both intervention sequences led to an increase in handwashing frequency, intention, self-efficacy, and planning. Also, overall gains were found for the self-regulatory module (increased planning and self-efficacy levels) and the motivational module (intention). Within groups, the self-regulatory module appeared to be more effective than the motivational module, independent of sequence. Self-regulatory interventions can help individuals to exhibit more handwashing. Sequencing may be important as a motivation module (Mot) first helps to set the goal and a self-regulatory module (SelfR) then helps to translate this goal into actual behavior, but further research is needed to evaluate mechanisms.

  8. The effect of chronic progressive-dose sodium bicarbonate ingestion on CrossFit-like performance: A double-blind, randomized cross-over trial.

    Science.gov (United States)

    Durkalec-Michalski, Krzysztof; Zawieja, Emilia E; Podgórski, Tomasz; Łoniewski, Igor; Zawieja, Bogna E; Warzybok, Marta; Jeszka, Jan

    2018-01-01

    Sodium bicarbonate (SB) has been proposed as an ergogenic aid, as it improves high-intensity and resistance exercise performance. However, no studies have yet investigated SB application in CrossFit. This study examined the effects of chronic, progressive-dose SB ingestion on CrossFit-like performance and aerobic capacity. In a randomized, double-blind, cross-over trial, 21 CrossFit-trained participants were randomly allocated to 2 groups and underwent 2 trials separated by a 14-day washout period. Participants ingested either up to 150 mg∙kg-1 of SB in a progressive-dose regimen or placebo for 10 days. Before and after each trial, Fight Gone Bad (FGB) and incremental cycling (ICT) tests were performed. In order to examine biochemical responses, blood samples were obtained prior to and 3 min after completing each exercise test. No gastrointestinal (GI) side effects were reported during the entire protocol. The overall FGB performance improved under SB by ~6.1% (pCrossFit-like performance, as well as delayed ventilatory threshold occurrence.

  9. 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.

  10. 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.

  11. A double-blind placebo-controlled cross-over clinical trial of DONepezil In Posterior cortical atrophy due to underlying Alzheimer's Disease: DONIPAD study.

    Science.gov (United States)

    Ridha, Basil H; Crutch, Sebastian; Cutler, Dawn; Frost, Christopher; Knight, William; Barker, Suzie; Epie, Norah; Warrington, Elizabeth K; Kukkastenvehmas, Riitta; Douglas, Jane; Rossor, Martin N

    2018-05-01

    The study investigated whether donepezil exerts symptomatic benefit in patients with posterior cortical atrophy (PCA), an atypical variant of Alzheimer's disease. A single-centre, double-blind, placebo-controlled, cross-over clinical trial was performed to assess the efficacy of donepezil in patients with PCA. Each patient received either donepezil (5 mg once daily in the first 6 weeks and 10 mg once daily in the second 6 weeks) or placebo for 12 weeks. After a 2-week washout period, each patient received the other treatment arm during the following 12 weeks followed by another 2-week washout period. The primary outcome was the Mini-Mental State Examination (MMSE) at 12 weeks. Secondary outcome measures were five neuropsychological tests reflecting parieto-occipital function. Intention-to-treat analysis was used. For each outcome measure, carry-over effects were first assessed. If present, then analysis was restricted to the first 12-week period. Otherwise, the standard approach to the analysis of a 2 × 2 cross-over trial was used. Eighteen patients (13 females) were recruited (mean age 61.6 years). There was a protocol violation in one patient, who subsequently withdrew from the study due to gastrointestinal side effects. There was statistically significant (p effect on MMSE. Therefore, the analysis of treatment effect on MMSE was restricted to the first 12-week period. Treatment effect at 6 weeks was statistically significant (difference = 2.5 in favour of donepezil, 95% CI 0.1 to 5.0, p effect at 12 weeks was close, but not statistically significant (difference = 2.0 in favour of donepezil, 95% CI -0.1 to 4.5, p > 0.05). There were no statistically significant treatment effects on any of the five neuropsychological tests, except for digit span at 12 weeks (higher by 0.5 digits in favour of placebo, 95% CI 0.1 to 0.9). Gastrointestinal side effects occurred most frequently, affecting 13/18 subjects (72%), and were the cause of study discontinuation in one

  12. Mobile Application vs Paper Pictorial Blood Assessment Chart to Track Menses in Young Women: A Randomized Cross-over Design.

    Science.gov (United States)

    Jacobson, Amanda E; Vesely, Sara K; Haamid, Fareeda; Christian-Rancy, Myra; O'Brien, Sarah H

    2018-04-01

    Heavy menstrual bleeding is a common symptom reported by approximately 30% of women. The Pictorial Blood Assessment Chart (PBAC) score is often used to quantify severity of menstrual bleeding. However, the traditional PBAC paper diary might be subject to recall bias and compliance issues, especially in adolescents. We developed a mobile application (app) version of the PBAC score and evaluated patient satisfaction and compliance with app reporting vs paper reporting. DESIGN, SETTING, PARTICIPANTS, INTERVENTIONS, AND MAIN OUTCOME MEASURES: This study was a randomized cross-over study of 25 postmenarchal female adolescents and young women ages 13-21 years. Participants agreed to track bleeding in 2 consecutive menstrual cycles and were randomized to use the PBAC paper diary or mobile app format first. At the end of each cycle, a satisfaction survey and system usability scale (app only) was used to assess the acceptability of the format used. Twenty-five participants had a median age of 15 years. Cross-over analysis showed that satisfaction level was significantly higher for the app (P < .001). Twenty of 25 (80%) participants preferred the app over the paper diary. For the app, 20 of 25 participants (80%) had high compliance for reporting bleeding, with a mean of 2 app entries per day. Participants' PBAC scores did not vary significantly between the paper diary (median, 95) and mobile app (median, 114). All paper diaries met definition for high compliance. There was no significant period or carryover effect. This study showed that a PBAC app compared with the paper diary was the preferred method of recording menstrual bleeding in adolescents and showed feasibility as a research data collection tool. Copyright © 2017 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

  13. Preliminary report: prescription of prism-glasses by the Measurement and Correction Method of H.-J. Haase or by conventional orthoptic examination: a multicenter, randomized, double-blind, cross-over study

    NARCIS (Netherlands)

    Simonsz, H. J.; van Els, J.; Ruijter, J. M.; Bakker, D.; Spekreijse, H.

    2001-01-01

    In a multicenter, randomized, double-blind, cross-over study in the Netherlands, the effectiveness of (prism-)glasses prescribed by the Measurement and Correction Method of H.-J. Haase (MKH) was compared to that of glasses prescribed by conventional orthoptic examination. Nine pairs of

  14. C2 Nerve Field Stimulation for the Treatment of Fibromyalgia: A Prospective, Double-blind, Randomized, Controlled Cross-over Study.

    Science.gov (United States)

    Plazier, Mark; Ost, Jan; Stassijns, Gaëtane; De Ridder, Dirk; Vanneste, Sven

    2015-01-01

    Fibromyalgia is a condition characterized by widespread chronic pain. Due to the high prevalence and high costs, it has a substantial burden on society. Treatment results are diverse and only help a small subset of patients. C2 nerve field stimulation, aka occipital nerve stimulation, is helpful and a minimally invasive treatment for primary headache syndromes. Small C2 pilot studies seem to be beneficial in fibromyalgia. Forty patients were implanted with a subcutaneous electrode in the C2 dermatoma as part of a prospective, double-blind, randomized, controlled cross-over study followed by an open label follow up period of 6 months. The patients underwent 2 week periods of different doses of stimulation consisting of minimal (.1 mA), subthreshold, and suprathreshold (for paresthesias) in a randomized order. Twenty seven patients received a permanent implant and 25 completed the 6 month open label follow up period. During the 6 week trial phase of the study, patients had an overall decrease of 36% on the fibromyalgia impact questionnaire (FIQ), a decrease of 33% fibromyalgia pain and improvement of 42% on the impact on daily life activities and quality. These results imply an overall improvement in the disease burden, maintained at 6 months follow up, as well as an improvement in life quality of 50%. Seventy six percent of patients were satisfied or very satisfied with their treatment. There seems to be a dose-response curve, with increasing amplitudes leading to better clinical outcomes. Subcutaneous C2 nerve field stimulation seems to offer a safe and effective treatment option for selected medically intractable patients with fibromyalgia. Copyright © 2015 Elsevier Inc. All rights reserved.

  15. 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).

  16. Effects of formulation on the bioavailability of lutein and zeaxanthin: a randomized, double-blind, cross-over, comparative, single-dose study in healthy subjects.

    Science.gov (United States)

    Evans, Malkanthi; Beck, Mareike; Elliott, James; Etheve, Stephane; Roberts, Richard; Schalch, Wolfgang

    2013-06-01

    Lutein and zeaxanthin are macular pigments with a protective function in the retina. These xanthophylls must be obtained from the diet or added to foods or supplements via easy-to-use, stable formulations. The technique employed to produce these formulations may affect the bioavailability of the xanthophylls. Forty-eight healthy volunteers were randomized into this double-blind, cross-over study investigating the plasma kinetics of lutein provided as two different beadlet formulations. Subjects (n = 48) received a single dose of 20 mg of lutein as either a starch-matrix ("SMB", FloraGLO® Lutein 5 %) or as a cross-linked alginate-matrix beadlet ("AMB", Lyc-O-Lutein 20 %) formulation. Plasma concentrations of lutein and zeaxanthin were measured at 0, 1, 3, 6, 9, 12, 14, 24, 26, 28, 32, 36, 48, 72, 168, and 672 h. The mean plasma AUC(0-72h), AUC(0-672h), and C(max) for total lutein and zeaxanthin and their all-E-isomers were significantly increased (p < 0.001) from pre-dose concentrations in response to SMB and AMB. There was no difference in lutein T max between the two test articles. However, by 14 h post-dose, total plasma lutein increased by 7 % with AMB and by 126 % with SMB. Total lutein AUC(0-72h) and AUC(0-672h) were 1.8-fold and 1.3-fold higher, respectively, for SMB compared to AMB. Both formulations were well tolerated by subjects in this study. These findings confirm that the bioavailability of lutein and zeaxanthin critically depends on the formulation used and document a superiority of the starch-based over the alginate-based product in this study.

  17. Effects of Pycnogenol on endothelial function in patients with stable coronary artery disease: a double-blind, randomized, placebo-controlled, cross-over study.

    Science.gov (United States)

    Enseleit, Frank; Sudano, Isabella; Périat, Daniel; Winnik, Stephan; Wolfrum, Mathias; Flammer, Andreas J; Fröhlich, Georg M; Kaiser, Priska; Hirt, Astrid; Haile, Sarah R; Krasniqi, Nazmi; Matter, Christian M; Uhlenhut, Klaus; Högger, Petra; Neidhart, Michel; Lüscher, Thomas F; Ruschitzka, Frank; Noll, Georg

    2012-07-01

    Extracts from pine tree bark containing a variety of flavonoids have been used in traditional medicine. Pycnogenol is a proprietary bark extract of the French maritime pine tree (Pinus pinaster ssp. atlantica) that exerts antioxidative, anti-inflammatory, and anti-platelet effects. However, the effects of Pycnogenol on endothelial dysfunction, a precursor of atherosclerosis and cardiovascular events, remain still elusive. Twenty-three patients with coronary artery disease (CAD) completed this randomized, double-blind, placebo-controlled cross-over study. Patients received Pycnogenol (200 mg/day) for 8 weeks followed by placebo or vice versa on top of standard cardiovascular therapy. Between the two treatment periods, a 2-week washout period was scheduled. At baseline and after each treatment period, endothelial function, non-invasively assessed by flow-mediated dilatation (FMD) of the brachial artery using high-resolution ultrasound, biomarkers of oxidative stress and inflammation, platelet adhesion, and 24 h blood pressure monitoring were evaluated. In CAD patients, Pycnogenol treatment was associated with an improvement of FMD from 5.3 ± 2.6 to 7.0 ± 3.1 (P effect 2.75; 95% confidence interval (CI): 1.75, 3.75, P < 0.0001]. 15-F(2t)-Isoprostane, an index of oxidative stress, significantly decreased from 0.71 ± 0.09 to 0.66 ± 0.13 after Pycnogenol treatment, while no change was observed in the placebo group (mean difference 0.06 pg/mL with an associated 95% CI (0.01, 0.11), P = 0.012]. Inflammation markers, platelet adhesion, and blood pressure did not change after treatment with Pycnogenol or placebo. This study provides the first evidence that the antioxidant Pycnogenol improves endothelial function in patients with CAD by reducing oxidative stress.

  18. Effects of Sodium Bicarbonate on High-Intensity Endurance Performance in Cyclists: A Double-Blind, Randomized Cross-Over Trial.

    Directory of Open Access Journals (Sweden)

    Florian Egger

    Full Text Available While the ergogenic effect of sodium bicarbonate (BICA on short-term, sprint-type performance has been repeatedly demonstrated, little is known about its effectiveness during prolonged high-intensity exercise in well-trained athletes. Therefore, this study aims to examine the influence of BICA on performance during exhaustive, high-intensity endurance cycling.This was a single-center, double-blind, randomized, placebo-controlled cross-over study. Twenty-one well-trained cyclists (mean ± SD: age 24±8 y, BMI 21.3±1.7, VO2peak 67.3±9.8 ml·kg-1·min-1 were randomly allocated to sequences of following interventions: oral ingestion of 0.3 g·kg-1 BICA or 4 g of sodium chloride (placebo, respectively. One h after ingestion subjects exercised for 30 min at 95% of the individual anaerobic threshold (IAT followed by 110% IAT until exhaustion. Prior to these constant load tests stepwise incremental exercise tests were conducted under both conditions to determine IAT and VO2peak. Analysis of blood gas parameters, blood lactate (BLa and gas exchange measurements were conducted before, during and after the tests. The main outcome measure was the time to exhaustion in the constant load test.Cycling time to exhaustion was improved (p<0.05 under BICA (49.5±11.5 min compared with placebo (45.0±9.5 min. No differences in maximal or sub-maximal measures of performance were observed during stepwise incremental tests. BICA ingestion resulted in an increased pH, bicarbonate concentration and BLa before, throughout and after both exercise testing modes.The results suggest that ingestion of BICA may improve prolonged, high-intensity cycling performance.German Clinical Trials Register (DRKS DRKS00006198.

  19. 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

  20. Effects of Baseplates of Orthodontic Appliances with in situ generated Silver Nanoparticles on Cariogenic Bacteria: A Randomized, Double-blind Cross-over Clinical Trial.

    Science.gov (United States)

    Ghorbanzadeh, Roghayeh; Pourakbari, Babak; Bahador, Abbas

    2015-04-01

    Polymethyl-methacrylate (PMMA) is commonly used primarily for baseplates of orthodontic appliances (BOA). The activities of cariogenic bacteria in biofilm on these surfaces may contribute to dental caries, gingival inflammation and periodontal disease. The PMMA incorporated with nanoparticles of silver (NanoAg-I-PMMA) and NanoAg in situ in PMMA (NanoAg-IS-PMMA) have been shown to control the growth of cariogenic bacteria, but clinical trial of anti-cariogenic application of these novel materials in orthodontics has not been evaluated. The main aim of the study is to compare the clinical effectiveness of using NanoAg-IS-PMMA and NanoAg-I-PMMA for construction of new BOA in inhibiting the planktonic growth and biofilm formation of the cariogenic bacteria. Twenty four patients with a median age of 12.6 years (7-15) harboring Streptococcus mutans, Streptococcus sobrinus and Lactobacillus acidophilus as well as Lactobacillus casei participated in the randomized, double-blind, cross-over study. The experimental BOA, NanoAg-IS-BOA and NanoAg-I-BOA, contained 0.5% w/w NanoAg while the control BOA was standard PMMA. Antibacterial effect of NanoAg-IS-BOA and NanoAg-I-BOA was assessed against test cariogenic bacteria by planktonic and biofilm bacterial cells growth inhibition. The average levels of test cariogenic bacteria in saliva decreased about 2 to 70 fold (30.9-98.4%) compared to baseline depending on the microorganism type and test BOA. Biofilm inhibition analysis demonstrated that NanoAg-I-BOA and NanoAg-IS-BOA inhibited the biofilm of all test bacteria by 20.1 to 79.9% compared to BOA. NanoAg-IS-BOA had a strong anti-biofilm effect against S. mutans, S. sobrinus and L. casei. However, NanoAg-I-BOA showed only slight anti-biofilm effects on test bacteria. Most notably, at all period of the clinical trial, NanoAg-IS-BOA showed a higher antibacterial activity than NanoAg-I-BOA. Based on the novel data that presented here, the NanoAg-IS-BOA had strong antimicrobial

  1. 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

    The objective of this study was to test the efficacy of intravenously administered S-adenosyl-L-methionine (SAMe) in patients with fibromyalgia (FM). Thirty-four out-patients with fibromyalgia symptoms received SAMe 600 mg i.v. or placebo daily for 10 days in a cross-over trial. There was no sign......The objective of this study was to test the efficacy of intravenously administered S-adenosyl-L-methionine (SAMe) in patients with fibromyalgia (FM). Thirty-four out-patients with fibromyalgia symptoms received SAMe 600 mg i.v. or placebo daily for 10 days in a cross-over trial.......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...

  2. 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

    The objective of this study was to test the efficacy of intravenously administered S-adenosyl-L-methionine (SAMe) in patients with fibromyalgia (FM). Thirty-four out-patients with fibromyalgia symptoms received SAMe 600 mg i.v. or placebo daily for 10 days in a cross-over trial. There was no sign......The objective of this study was to test the efficacy of intravenously administered S-adenosyl-L-methionine (SAMe) in patients with fibromyalgia (FM). Thirty-four out-patients with fibromyalgia symptoms received SAMe 600 mg i.v. or placebo daily for 10 days in a cross-over trial....... 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...

  3. 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.

  4. 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

  5. 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

    Directory of Open Access Journals (Sweden)

    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.

  6. Slow-release L-cysteine capsule prevents gastric mucosa exposure to carcinogenic acetaldehyde: results of a randomised single-blinded, cross-over study of Helicobacter-associated atrophic gastritis.

    Science.gov (United States)

    Hellström, Per M; Hendolin, Panu; Kaihovaara, Pertti; Kronberg, Leif; Meierjohann, Axel; Millerhovf, Anders; Paloheimo, Lea; Sundelin, Heidi; Syrjänen, Kari; Webb, Dominic-Luc; Salaspuro, Mikko

    2017-02-01

    Helicobacter-induced atrophic gastritis with a hypochlorhydric milieu is a risk factor for gastric cancer. Microbes colonising acid-free stomach oxidise ethanol to acetaldehyde, a recognised group 1 carcinogen. To assess gastric production of acetaldehyde and its inert condensation product, non-toxic 2-methyl-1,3-thiazolidine-4-carboxylic acid (MTCA), after alcohol intake under treatment with slow-release L-cysteine or placebo. Seven patients with biopsy-confirmed atrophic gastritis, low serum pepsinogen and high gastrin-17 were studied in a cross-over single-blinded design. On separate days, patients randomly received 200 mg slow-release L-cysteine or placebo with intragastric instillation of 15% (0.3 g/kg) ethanol. After intake, gastric concentrations of ethanol, acetaldehyde, L-cysteine and MTCA were analysed. Administration of L-cysteine increased MTCA (p L-cysteine level was 7552 ± 2687 μmol/L at 40 min and peak MTCA level 196 ± 98 μmol/L at 80 min after intake. Gastric L-cysteine and MTCA concentrations were maintained for 3 h. The AUC for MTCA was 11-fold higher than acetaldehyde, indicating gastric first-pass metabolism of ethanol. With placebo, acetaldehyde remained elevated also at low ethanol concentrations representing 'non-alcoholic' beverages and food items. After gastric ethanol instillation, slow-release L-cysteine eliminates acetaldehyde to form inactive MTCA, which remains in gastric juice for up to 3 h. High acetaldehyde levels indicate a marked gastric first-pass metabolism of ethanol resulting in gastric accumulation of carcinogenic acetaldehyde. Local exposure of the gastric mucosa to acetaldehyde can be mitigated by slow-release L-cysteine capsules.

  7. A single-blind cross over study investigating the efficacy of standard and controlled release levodopa in combination with entacapone in the treatment of end-of-dose effect in people with Parkinson's disease.

    Science.gov (United States)

    Iansek, R; Danoudis, M

    2011-08-01

    To determine the efficacy of standard levodopa combined with controlled release levodopa and entacapone in controlling end-of-dose symptoms in Parkinson's disease. A single-blind cross over design was used to compare the duration of action for three pharmacological combinations: standard levodopa (L/DDC); standard levodopa combined with entacapone (L/DDC/E); and standard levodopa combined with controlled release levodopa (CR) and entacapone (L/DDC/CR/E). Thirty two participants with wearing-off symptoms and inadequate symptom control with L/DDC/E had their optimum dose of L/DDC determined at base line. Entacapone was added to the optimal L/DDC dose and duration of action determined. Levodopa CR dosage was adjusted to match the optimal L/DDC dose for each participant. All participants were then trialed on L/DDC/CR/E and duration of response calculated. Timed Up and Go (TUG) times and magnitude of extra movements were recorded hourly throughout the day over several days to determine the optimum interval between doses for each combination. The UPDRS (Sections 2 and 3), PDQ39 and fatigue scale, the PDF-16, were recorded at base line and when dosage intervals had stabilized on L/DDC/CR/E. Duration of response was greatest with L/DDC/CR/E compared to L/DDC/E (p DDC/CR/E compared to L/DDC/E (p DDC/CR/E compared to L/DDC (p DDC/CR/E (p = 0.001) however magnitude was mild. Combining standard levodopa and levodopa CR preparations with entacapone is an additional treatment strategy to manage motor fluctuations in advanced PD. Copyright © 2011 Elsevier Ltd. All rights reserved.

  8. Effective cross-over to granisetron after failure to ondansetron, a randomized double blind study in patients failing ondansetron plus dexamethasone during the first 24 hours following highly emetogenic chemotherapy

    Science.gov (United States)

    de Wit, R; de Boer, A C; vd Linden, G H M; Stoter, G; Sparreboom, A; Verweij, J

    2001-01-01

    In view of the similarity in chemical structure of the available 5HT3-receptor antagonists it is assumed, whilst these agents all act at the same receptor, that failure to one agent would predict subsequent failure to all 5HT3-receptor antagonists. We conducted a randomized double blind trial of granisetron 3 mg plus dexamethasone 10 mg versus continued treatment with ondansetron 8 mg plus dexamethasone 10 mg in patients with protection failure on ondansetron 8 mg plus dexamethasone 10 mg during the first 24 hours following highly emetogenic chemotherapy. Of 40 eligible patients, 21 received ondansetron + dexamethasone and 19 received granisetron + dexamethasone. We found a significant benefit from crossing-over to granisetron after failure on ondansetron. Of the 19 patients who crossed over to granisetron, 9 patients obtained complete protection, whereas this was observed in 1 of the 21 patients continuing ondansetron, P = 0.005. These results indicate that there is no complete cross-resistance between 5HT3-receptor antagonists, and that patients who have acute protection failure on one 5HT3-receptor antagonist should be offered cross-over to another 5HT3-receptor antagonist. © 2001 Cancer Research Campaign  http://www.bjcancer.com PMID:11710819

  9. 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.

  10. Blindness in designing intelligent systems

    Science.gov (United States)

    Denning, Peter J.

    1988-01-01

    New investigations of the foundations of artificial intelligence are challenging the hypothesis that problem solving is the cornerstone of intelligence. New distinctions among three domains of concern for humans--description, action, and commitment--have revealed that the design process for programmable machines, such as expert systems, is based on descriptions of actions and induces blindness to nonanalytic action and commitment. Design processes focusing in the domain of description are likely to yield programs like burearcracies: rigid, obtuse, impersonal, and unable to adapt to changing circumstances. Systems that learn from their past actions, and systems that organize information for interpretation by human experts, are more likely to be successful in areas where expert systems have failed.

  11. 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.

  12. 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 yogurt cultures and acid lactase increases 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.

  13. 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.

  14. 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.

  15. Protective effect of budesonide/formoterol compared with formoterol, salbutamol and placebo on repeated provocations with inhaled AMP in patients with asthma: a randomised, double-blind, cross-over study

    Directory of Open Access Journals (Sweden)

    van der Woude Hanneke J

    2010-05-01

    Full Text Available Abstract Background The budesonide/formoterol combination is successfully used for fast relief of asthma symptoms in addition to its use as maintenance therapy. The temporarily increased corticosteroid dose during increasing inhaler use for symptom relief is likely to suppress any temporary increase in airway inflammation and may mitigate or prevent asthma exacerbations. The relative contribution of the budesonide and formoterol components to the improved asthma control is unclear. Methods The acute protective effect of inhaled budesonide was tested in a model of temporarily increased airway inflammation with repeated indirect airway challenges, mimicking an acute asthma exacerbation. A randomised, double-blind, cross-over study design was used. Asthmatic patients (n = 17, mean FEV1 95% of predicted who previously demonstrated a ≥30% fall in forced expiratory volume in 1 second (FEV1 after inhaling adenosine 5'-monophosphate (AMP, were challenged on four consecutive test days, with the same dose of AMP (at 09:00, 12:00 and 16:00 hours. Within 1 minute of the maximal AMP-induced bronchoconstriction at 09:00 hours, the patients inhaled one dose of either budesonide/formoterol (160/4.5 μg, formoterol (4.5 μg, salbutamol (2 × 100 μg or placebo. The protective effects of the randomised treatments were assessed by serial lung function measurements over the test day. Results In the AMP provocations at 3 and 7 hours after inhalation, the budesonide/formoterol combination provided a greater protective effect against AMP-induced bronchoconstriction compared with formoterol alone, salbutamol and placebo. In addition all three active treatments significantly increased FEV1 within 3 minutes of administration, at a time when inhaled AMP had induced the 30% fall in FEV1. Conclusions A single dose of budesonide/formoterol provided a greater protective effect against inhaled AMP-induced bronchoconstriction than formoterol alone, both at 3 and at 7 hours

  16. Cross-over

    DEFF Research Database (Denmark)

    Mørck, Line Lerche; Christensen, Tina Wilchen

    at skabe blinde pletter, fordi ordet tenderer til at rette vores opmærksomhed på én smal og lineær bevægelse fra kriminalitet og bandetilhør til islamisk ekstremisme. Denne pjece giver et billede af de komplekse bevægelsesmønstre i og på tværs af kriminelle netværk, bander, rockere og ekstreme grupper. Den...... giver en nuanceret forståelse af de veje ind, processer og perspektiver, der er nødvendige at begribe, når man skal udvikle og arbejde med forebyggelse af radikalisering. Pjecen er skrevet af forskere ved DPU, Aarhus Universitet og er finansieret af Udlændinge og Integrationsministeriet....

  17. A randomized, double-blind, cross-over, phase IV trial of oros-methylphenidate (CONCERTA(®)) and generic novo-methylphenidate ER-C (NOVO-generic).

    Science.gov (United States)

    Fallu, Angelo; Dabouz, Farida; Furtado, Melissa; Anand, Leena; Katzman, Martin A

    2016-08-01

    Attention-deficit/hyperactivity disorder (ADHD) is a common neurobehavioral disorder with onset during childhood. Multiple aspects of a child's development are hindered, in both home and school settings, with negative impacts on social, emotional, and cognitive functioning. If left untreated, ADHD is commonly associated with poor academic achievement and low occupational status, as well as increased risk of substance abuse and delinquency. The objective of this study was to evaluate adult ADHD subject reported outcomes when switched from a stable dose of CONCERTA(®) to the same dose of generic Novo-methylphenidate ER-C(®). Randomized, double-blind, cross-over, phase IV trial consisted of two phases in which participants with a primary diagnosis of ADHD were randomized in a 1:1 ratio to 3 weeks of treatment with CONCERTA or generic Novo-Methylphenidate ER-C. Following 3 weeks of treatment, participants were crossed-over to receive the other treatment for an additional 3 weeks. Primary efficacy was assessed through the use of the Treatment Satisfaction Questionnaire for Medication, Version II (TSQM-II). Participants with ADHD treated with CONCERTA were more satisfied in terms of efficacy and side effects compared to those receiving an equivalent dose of generic Novo-Methylphenidate ER-C. All participants chose to continue with CONCERTA treatment at the conclusion of the study. Although CONCERTA and generic Novo-Methylphenidate ER-C have been deemed bioequivalent, however the present findings demonstrate clinically and statistically significant differences between generic and branded CONCERTA. Further investigation of these differences is warranted.

  18. 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 (Pgut microbiota response and are therefore more likely to benefit from an inulin-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.

  19. A double-blind, placebo-controlled, cross-over study to establish the bifidogenic effect of a very-long-chain inulin extracted from globe artichoke (Cynara scolymus) in healthy human subjects.

    Science.gov (United States)

    Costabile, Adele; Kolida, Sofia; Klinder, Annett; Gietl, Eva; Bäuerlein, Michael; Frohberg, Claus; Landschütze, Volker; Gibson, Glenn R

    2010-10-01

    There is growing interest in the use of inulins as substrates for the selective growth of beneficial gut bacteria such as bifidobacteria and lactobacilli because recent studies have established that their prebiotic effect is linked to several health benefits. In the present study, the impact of a very-long-chain inulin (VLCI), derived from globe artichoke (Cynara scolymus), on the human intestinal microbiota compared with maltodextrin was determined. A double-blind, cross-over study was carried out in thirty-two healthy adults who were randomised into two groups and consumed 10 g/d of either VLCI or maltodextrin, for two 3-week study periods, separated by a 3-week washout period. Numbers of faecal bifidobacteria and lactobacilli were significantly higher upon VLCI ingestion compared with the placebo. Additionally, levels of Atopobium group significantly increased, while Bacteroides-Prevotella numbers were significantly reduced. No significant changes in faecal SCFA concentrations were observed. There were no adverse gastrointestinal symptoms apart from a significant increase in mild and moderate bloating upon VLCI ingestion. These observations were also confirmed by in vitro gas production measurements. In conclusion, daily consumption of VLCI extracted from globe artichoke exerted a pronounced prebiotic effect on the human faecal microbiota composition and was well tolerated by all volunteers.

  20. Effects of a new combination of nutraceuticals with Morus alba on lipid profile, insulin sensitivity and endotelial function in dyslipidemic subjects. A cross-over, randomized, double-blind trial.

    Science.gov (United States)

    Trimarco, Valentina; Izzo, Raffaele; Stabile, Eugenio; Rozza, Francesco; Santoro, Mario; Manzi, Maria Virginia; Serino, Federica; Schiattarella, Gabriele Giacomo; Esposito, Giovanni; Trimarco, Bruno

    2015-06-01

    Nutraceuticals (NUT) are forms of compounds with biological activity commonly used to improve health in dosage largely exceeding those obtainable in food. We compared, in a double blind randomized cross-over trial, the effects of two NUT combinations on the control of glico-lipidic metabolism in patients with hypercholesterolemia not on statins. At study start patients were given dietary counseling and received placebo for 2 weeks. After this run-in period, patients were randomized: (1) Combination A [Policosanol, Red yeast rice (Monakolin K 3 mg), Berberine 500 mg, Astaxantine, Folic Acid and Coenzyme Q10] for 4 weeks followed by 4 weeks of Combination B [Red yeast rice (Monakolin K 3.3 mg), Berberine 531.25 mg and leaf extract of Morus alba]; (2) Combination B for 4 weeks followed by 4 weeks of Combination A. Combination B reduced LDL cholesterol below 130 mg/dl in 56.5 % of the patients, and Cambination A only in 21.7 % of them (p ≤ 0.027). Both treatments reduced plasma levels of triglycerides, total and LDL cholesterol and increased HDL cholesterol (all p Morus alba extract improves the effect on plasma cholesterol and on glucose metabolism of the NUT Combination. These effects may allow the speculation of a more marked improvement in cardiovascular prognosis.

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

    Directory of Open Access Journals (Sweden)

    Anna Pedret

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

  2. 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 (P<0·05) with probiotic 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.

  3. 
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.
.

  4. 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.

  5. 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

  6. 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

  7. Spinal Orthoses: The Crucial Role of Comfort on Compliance of Wearing - Monocentric Prospective Pilot Study of Randomized Cross-Over Design.

    Science.gov (United States)

    Herget, G W; Patermann, S; Strohm, P C; Zwingmann, J; Eichelberger, P; Südkamp, N P; Hirschmüller, A

    2017-01-01

    PURPOSE OF THE STUDY Various spine disorders are regularly treated by orthoses, and success of treatment depends on wearing these devices. In this study we examined the compliance, wear comfort, subjective stabilization and side effects associated with spinal orthoses using an individualized questionnaire and the Compact Short Form-12 Health Survey (SF-12). MATERIAL AND METHODS In this prospective pilot study of randomized cross-over design, twelve healthy volunteers with a mean age of 31.2 years wore three different types of orthoses, each for one week: A hyperextension brace (HB), a custom-made semirigid orthosis (SO) and a custom-made rigid orthosis (RO). The daily duration of wearing the orthosis was defined as primary endpoint; contentment was measured using an individualized questionnaire and the standardized SF-12. RESULTS In the study population calculated probability of wearing the HB and RO was between 0.2 und 38.5% (95% confidence interval). No volunteer wore the SO orthosis for the predefined time. The SO and RO each displayed high subjective stabilization, while the RO was more often associated with side effects like skin pressure marks than the SO. The need for rework due to discomfort was mainly necessary with the RO. We observed no substantial differences in feeling compression and sweating. Noteworthy, eight of 12 subjects complained of uncomfortable sternal pressure due to the upper pad of the HB. The SF-12: scores ranged from 52.1 to 48.6 on the physical (PCS), and from 53.7 to 50.8 on the mental component score (MCS), demonstrating an influence on QoL. DISCUSSION AND CONCLUSIONS The design as well as the orthosis itself influence the compliance of wearing and exert a moderate negative, but acceptable impact on QoL. The SO appeared to correlate with the best overall compromise between comfort and subjective stabilization. Further investigations are necessary in patients with spinal diseases, for whom the effect of orthosis wearing may surpass the

  8. Cross-Over Clinical Trials?

    Directory of Open Access Journals (Sweden)

    Latif Gachkar

    2017-01-01

    Full Text Available Abstract Cross-Over Clinical Trials in comparison with Parallel groups clinical trials have some advantages such as control of confounding variables, small sample size, and short time to implement the research project. But this type of research has few essential limitations that discusses in this monogram.

  9. Impact of the cosmetic mouthwash “Jack Pro Spülung plus” (“rheodol-Spülung plus” on the oral cavity flora, tested in a monocentric, controlled, randomized, blind, cross-over comparative study

    Directory of Open Access Journals (Sweden)

    Göhring, Jana

    2014-03-01

    Full Text Available [english] Aim: Jack Pro Spülung Plus (also available as “rheodol-Spülung plus” is recommended to mechanically maintain oral hygiene as part of an overall oral hygiene concept. Because Jack Pro Spülung Plus contains the active agents polihexanide and tosylchloramide sodium in concentrations below microbicidal efficacy, this study tested the hypothesis that the combination of mechanical rinsing and bacteriostatic effect surpasses the effect of mechanical rinsing alone.Method: The study was performed with 30 volunteers as a monocentric, controlled, randomized, blind, cross-over comparative study. The efficacy of the test product (active agents polihexanide 0.02–0.03% and tosylchloramide sodium 0.004–0.006% was compared to an aqueous solution of polihexanide (0.02–0.03% and to Ringer solution as negative control. The efficacy was measured as the reduction of colony forming units (cfu on buccal mucosa after aerobic and anaerobic cultivation. After determination of pre-values, the volunteers performed mouthrinsing for 30 sec with each of the 3 tested solutions. After 1, 10 and 60 minutes, cfu numbers were determined again. The reduction factor was calculated as the difference between log of the measured cfu before and after mouthrinsing with the test solution. The sampling was performed using a template with a smear area of 1 x 1 cm. Results: Using Ringer solution led to a slight mechanically-induced reduction of cfu in the oral cavity 1 min after rinsing the mouth cavity with the solution. After 10 min and 60 min, no influence on the cfu number could be detected. Using Jack pro Spülung Plus led to a bacteriostatic effect up to 60 min after mouthrinsing; 10 min and 60 min after rinsing the efficacy of Ringer solution was also significantly surpassed. The aqueous solution of polihexanide was less effective than Jack pro Spülung Plus after 10 and 60 min. Conclusion: Based on these observations, we conclude that Jack pro Spülung Plus is

  10. 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

    2017-01-01

    Introduction 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. Methods and analysis 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 and dissemination Ethics approval was obtained by the East of Scotland Research Ethics Service. Results of the trial will be submitted for publication in a peer

  11. 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

  12. 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

  13. 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

  14. 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

    BACKGROUND: In a recent double-blind placebo-controlled crossover-study the "immune stimulatory" effects (activation of macrophages leading to enhanced phagocytosis and production of several cytokines) of Echinacea purpurea preparations (EPP) which were observed in vitro experiments and following...

  15. 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...

  16. An evaluation of the cognitive and mood effects of an energy shot over a 6h period in volunteers: a randomized, double-blind, placebo controlled, cross-over study.

    Science.gov (United States)

    Wesnes, Keith A; Barrett, Marilyn L; Udani, Jay K

    2013-08-01

    Energy drinks are widely available mostly containing glucose, and several have been demonstrated to improve alertness and cognitive function; these effects generally being identified 30-60min after administration. The present study assessed whether an energy shot without carbohydrates would affect major aspects of cognitive function and also mood in volunteers over a 6h time period. This randomized, double-blind, placebo-controlled,crossover study compared the acute effects of the energy shot with a matching placebo in 94 healthy volunteers. Cognitive function was assessed with a widely used set of automated tests of attention and memory. Mood was assessed with the Bond-Lader, Beck Anxiety Index, Beck Depression Index, Chalder Fatigue Scales (CFS), and the POMS. The volunteers were requested to limit their sleep to between 3 and 6h the night before each testing day. Compared to the placebo, the energy shot significantly improved 6 validated composite cognitive function measures from the CDR System as well as self-rated alertness; the benefits on 4 of the cognitive measures still remaining at 6h. The overall effect sizes of the performance improvements were in the small to medium range and thus notable in this field. In conclusion, an energy shot can significantly improve important aspects of cognitive function for up to 6h compared to placebo in partially sleep-deprived healthy volunteers. Copyright © 2013 Elsevier Ltd. All rights reserved.

  17. Advantages and disadvantages of graduated and inverse graduated compression hosiery in patients with chronic venous insufficiency and healthy volunteers: A prospective, mono-centric, blinded, open randomised, controlled and cross-over trial.

    Science.gov (United States)

    Riebe, Helene; Konschake, Wolfgang; Haase, Hermann; Jünger, Michael

    2018-02-01

    Background The therapeutic effectiveness of compression therapy depends on the selection of compression hosiery. Objectives To assess efficacy and tolerability of graduated elastic compression stockings (GECS) and inverse graduated elastic compression stockings (PECS). Methods Thirty-two healthy volunteers and thirty-two patients with chronic venous insufficiency were analysed; wear period: one week for each stocking type (randomised, blinded). volume reduction of 'Lower leg' (Image3D®) and 'Distal leg and foot' (water plethysmography). clinical symptoms of chronic venous insufficiency assessed by the Venous Clinical Severity Score, side effects and wear comfort in both groups. Results Volume of 'Lower leg': significant reduction in healthy volunteers (mean GECS: -37.5 mL, mean PECS: -37.2 mL) and in patients (mean GECS: -55.6 mL, mean PECS: -41.6 mL). Volume of 'Distal lower leg and foot': significant reduction in healthy volunteers (mean GECS: -27 mL, mean PECS: -16.7 mL), significant reduction in patients by GECS (mean: -43.4 mL), but non-significant reduction by PECS (mean: -22.6 mL). Clinical symptoms of chronic venous insufficiency were improved significantly better with GECS than with PECS, p < 0.001. GECS led to more painful constrictions, p = 0.047, PECS slipped down more often, p < 0.001. Conclusion GECS and PECS reduce volume of the segment 'Lower leg' in patients and healthy volunteers. Patients' volume of the 'Distal lower leg and foot', however, were diminished significantly only by GECS ( p = 0.0001). Patients' complaints were improved by both GECS and PECS, and GECS were superior to PECS.

  18. 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.

  19. Transreplication and crossing over in Sordaria fimicola.

    Science.gov (United States)

    KITANI, Y; OLIVE, L S; EL-ANI, A S

    1961-09-08

    A study of the segregation of markers closely linked to the gray ascospore color locus in Sordaria fimicola reveals that there is a high incidence of crossing over very near the locus when it transreplicates, which is much more pronounced in 5:3 than in 6:2 asci. Also, a single 7:1 and several aberrant 4:4 asci are described. At a different spore color locus, transreplication yields only 6:2 ratios, while other spore color loci fail to transreplicate altogether

  20. A randomised, double-blind, cross-over trial to evaluate bread, in which gluten has been pre-digested by prolyl endoprotease treatment, in subjects self-reporting benefits of adopting a gluten-free or low-gluten diet.

    Science.gov (United States)

    Rees, Dinka; Holtrop, Grietje; Chope, Gemma; Moar, Kim M; Cruickshank, Morven; Hoggard, Nigel

    2018-03-01

    The aim of the present study was to determine if the enzyme Aspergillus niger prolyl endoprotease (ANPEP), which degrades the immunogenic proline-rich residues in gluten peptides, can be used in the development of new wheat products, suitable for gluten-sensitive (GS) individuals. We have carried out a double-blind, randomised, cross-over trial with two groups of adults; subjects, self-reporting benefits of adopting a gluten-free or low-gluten diet (GS, n 16) and a control non-GS group (n 12). For the trial, volunteers consumed four wheat breads: normal bread, bread treated with 0·8 or 1 % ANPEP and low-protein bread made from biscuit flour. Compared with controls, GS subjects had a favourable cardiovascular lipid profile - lower LDL (4·0 (sem 0·3) v. 2·8 (sem 0·2) mmol/l; P=0·008) and LDL:HDL ratio (3·2 (sem 0·4) v. 1·8 (sem 0·2); P=0·005) and modified haematological profile. The majority of the GS subjects followed a low-gluten lifestyle, which helps to reduce the gastrointestinal (GI) symptoms severity. The low-gluten lifestyle does not have any effect on the quality of life, fatigue or mental state of this population. Consumption of normal wheat bread increased GI symptoms in GS subjects compared with their habitual diet. ANPEP lowered the immunogenic gluten in the treated bread by approximately 40 %. However, when compared with the control bread for inducing GI symptoms, no treatment effects were apparent. ANPEP can be applied in the production of bread with taste, texture and appearance comparable with standard bread.

  1. Designing a stable feedback control system for blind image deconvolution.

    Science.gov (United States)

    Cheng, Shichao; Liu, Risheng; Fan, Xin; Luo, Zhongxuan

    2018-05-01

    Blind image deconvolution is one of the main low-level vision problems with wide applications. Many previous works manually design regularization to simultaneously estimate the latent sharp image and the blur kernel under maximum a posterior framework. However, it has been demonstrated that such joint estimation strategies may lead to the undesired trivial solution. In this paper, we present a novel perspective, using a stable feedback control system, to simulate the latent sharp image propagation. The controller of our system consists of regularization and guidance, which decide the sparsity and sharp features of latent image, respectively. Furthermore, the formational model of blind image is introduced into the feedback process to avoid the image restoration deviating from the stable point. The stability analysis of the system indicates the latent image propagation in blind deconvolution task can be efficiently estimated and controlled by cues and priors. Thus the kernel estimation used for image restoration becomes more precision. Experimental results show that our system is effective on image propagation, and can perform favorably against the state-of-the-art blind image deconvolution methods on different benchmark image sets and special blurred images. Copyright © 2018 Elsevier Ltd. All rights reserved.

  2. 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.

  3. 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

  4. 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.

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

    DEFF Research Database (Denmark)

    Vargas Brenes, Ronald

    enrolled in UNA attended education careers programmes or philosophy. So I asked myself: Why are blind people not interested in studying informatics? Then I learned about a blind student who was interested in enrolling in the system engineering career programme a few years ago, but she quit from her...... and efficient in ensuring equal opportunities for blind and sighted students, particularly in connection with system engineering or other computer science-related career programmes....

  6. The first interconnection 500 Kv Brazil - Argentina. The design aspects of the crossing over the Uruguay river; Primeira interconexao 500 kV Brasil-Argentina. Aspectos de projeto da travessia sobre o Rio Uruguai

    Energy Technology Data Exchange (ETDEWEB)

    Silva, Vilson Renato da [Engelineas Consultoria e Projetos Ltda., Porto Alegre, RS (Brazil)]. E-mail: engeline@portoweb.com.br; Silva, Joao Batista Guimaraes Ferreira da; Guimaraes, Rogerio Peixoto [ABB, Belo Horizonte, MG (Brazil); Menezes, Ruy Carlos Ramos de [Rio Grande do Sul Univ., Porto Alegre, RS (Brazil)

    2001-07-01

    This document reports some aspects involving the employed engineering solutions in the project for the crossing above the uruguay river at the border between Brazil and Argentina. It is approached the related design aspects to the chosen place for the crossing, investigations about the river flood quotas and mainly the design criteria, with emphasis in probabilistic methodology application for reliability evaluation and in the need of attending the established requirements by the Argentine regulator organs. Finally, it is made a design description standing out the plotation, structures and foundations.

  7. Crossing over...Markov meets Mendel.

    Science.gov (United States)

    Mneimneh, Saad

    2012-01-01

    Chromosomal crossover is a biological mechanism to combine parental traits. It is perhaps the first mechanism ever taught in any introductory biology class. The formulation of crossover, and resulting recombination, came about 100 years after Mendel's famous experiments. To a great extent, this formulation is consistent with the basic genetic findings of Mendel. More importantly, it provides a mathematical insight for his two laws (and corrects them). From a mathematical perspective, and while it retains similarities, genetic recombination guarantees diversity so that we do not rapidly converge to the same being. It is this diversity that made the study of biology possible. In particular, the problem of genetic mapping and linkage-one of the first efforts towards a computational approach to biology-relies heavily on the mathematical foundation of crossover and recombination. Nevertheless, as students we often overlook the mathematics of these phenomena. Emphasizing the mathematical aspect of Mendel's laws through crossover and recombination will prepare the students to make an early realization that biology, in addition to being experimental, IS a computational science. This can serve as a first step towards a broader curricular transformation in teaching biological sciences. I will show that a simple and modern treatment of Mendel's laws using a Markov chain will make this step possible, and it will only require basic college-level probability and calculus. My personal teaching experience confirms that students WANT to know Markov chains because they hear about them from bioinformaticists all the time. This entire exposition is based on three homework problems that I designed for a course in computational biology. A typical reader is, therefore, an instructional staff member or a student in a computational field (e.g., computer science, mathematics, statistics, computational biology, bioinformatics). However, other students may easily follow by omitting the

  8. Crossing over...Markov meets Mendel.

    Directory of Open Access Journals (Sweden)

    Saad Mneimneh

    Full Text Available Chromosomal crossover is a biological mechanism to combine parental traits. It is perhaps the first mechanism ever taught in any introductory biology class. The formulation of crossover, and resulting recombination, came about 100 years after Mendel's famous experiments. To a great extent, this formulation is consistent with the basic genetic findings of Mendel. More importantly, it provides a mathematical insight for his two laws (and corrects them. From a mathematical perspective, and while it retains similarities, genetic recombination guarantees diversity so that we do not rapidly converge to the same being. It is this diversity that made the study of biology possible. In particular, the problem of genetic mapping and linkage-one of the first efforts towards a computational approach to biology-relies heavily on the mathematical foundation of crossover and recombination. Nevertheless, as students we often overlook the mathematics of these phenomena. Emphasizing the mathematical aspect of Mendel's laws through crossover and recombination will prepare the students to make an early realization that biology, in addition to being experimental, IS a computational science. This can serve as a first step towards a broader curricular transformation in teaching biological sciences. I will show that a simple and modern treatment of Mendel's laws using a Markov chain will make this step possible, and it will only require basic college-level probability and calculus. My personal teaching experience confirms that students WANT to know Markov chains because they hear about them from bioinformaticists all the time. This entire exposition is based on three homework problems that I designed for a course in computational biology. A typical reader is, therefore, an instructional staff member or a student in a computational field (e.g., computer science, mathematics, statistics, computational biology, bioinformatics. However, other students may easily follow by

  9. Cross over of recurrence networks to random graphs and random ...

    Indian Academy of Sciences (India)

    2017-01-27

    Jan 27, 2017 ... that all recurrence networks can cross over to random geometric graphs by adding sufficient amount of noise to .... municative [19] or social [20], deviate from the random ..... He has shown that the spatial effects become.

  10. 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 ...

  11. 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.

  12. 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...

  13. 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 video as their 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

  14. 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.

  15. 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.

  16. 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 ...

  17. 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.

  18. 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…

  19. 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

  20. Response spectra by blind faults for design purpose of stiff structures on rock site

    International Nuclear Information System (INIS)

    Hiroyuki Mizutani; Kenichi Kato; Masayuki Takemura; Kazuhiko Yashiro; Kazuo Dan

    2005-01-01

    The goal of this paper is to propose the response spectra by blind faults for seismic design of nuclear power facilities. It is impossible to evaluate earthquake ground motions from blind faults, because the size and the location of blind fault cannot be identified even if the detailed geological surveys are conducted. From the viewpoint of seismic design, it is crucial to investigate the upper level of earthquake ground motions due to blind faults. In this paper, 41 earthquakes that occurred in the upper crust in Japan and California are selected and classified into the active and the blind fault types. On the basis of near-source strong motion records observed on rock sites, upper level of response spectra by blind faults is examined. The estimated upper level is as follows: the peak ground acceleration is 450 cm/s 2 , the flat level of the acceleration response spectra is 1200 cm/s 2 , and the flat level of the velocity response spectra is 100 cm/s on rock sites with shear wave velocity Vs of about 700 m/s. The upper level can envelop the observed response spectra in near-source region on rock sites. (authors)

  1. 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

  2. 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.......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...... minutes of elbow icing (control treatment). The order of treatments was randomized.Main outcome measures: Maximal knee extension strength (primary outcome), knee pain at rest and knee pain during the maximal knee extensions were measured 2-5 minutes before and 2-5 minutes after both treatments...

  3. Cilostazol induced migraine does not respond to sumatriptan in a double blind trial

    DEFF Research Database (Denmark)

    Falkenberg, Katrine; Dunga, Bára Óladóttir Á; Guo, Song

    2018-01-01

    participants were asked to subsequently treat their spontaneous attacks with sumatriptan (50 mg) or placebo in a double-blind cross-over design and 15 participants did so. RESULTS: Cilostazol induced headache with some migraine characteristics in all participants; 18 patients on the sumatriptan day and 19...

  4. 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

  5. Topical Nasal Anesthesia in Flexible Bronchoscopy--A Cross-Over Comparison between Two Devices.

    Directory of Open Access Journals (Sweden)

    Thomas Fuehner

    Full Text Available Topical airway anesthesia is known to improve tolerance and patient satisfaction during flexible bronchoscopy (FB. Lidocaine is commonly used, delivered as an atomized spray. The current study assesses safety and patient satisfaction for nasal anesthesia of a new atomization device during outpatient bronchoscopy in lung transplant recipients.Using a prospective, non-blinded, cross-over design, patients enrolled between 01-10-2014 and 24-11-2014 received 2% lidocaine using the standard reusable nasal atomizer (CRNA. Those enrolled between 25-11-2014 and 30-01-2015, received a disposable intranasal mucosal atomization device (DIMAD. After each procedure, the treating physician, their assistant and the patient independently rated side-effects and satisfaction, basing their responses on visual analogue scales (VAS. At their next scheduled bronchoscopy during the study period, patients then received the alternative atomizer. Written consent was obtained prior to the first bronchoscopy, and the study approved by the institutional ethics committee.Of the 252 patients enrolled between 01-10-2014 and 30-01-2015, 80 (32% received both atomizers. Physicians reported better efficacy (p = 0.001 and fewer side effects (p< = 0.001 for DIMAD in patients exposed to both procedures. Among patients with one visit, physicians and their assistants reported improved efficacy (p = 0.018, p = 0.002 and fewer side effects (p< = 0.001, p = 0.029 for the disposable atomizer, whereas patients reported no difference in efficacy or side effects (p = 0.72 and p = 0.20. No severe adverse events were noted. The cost of the reusable device was 4.08€ per procedure, compared to 3.70€ for the disposable device.Topical nasal anesthesia via a disposable intranasal mucosal atomization device (DIMAD offers comparable safety and patient comfort, compared to conventional reusable nasal atomizers (CRNA in lung transplant recipients. Procedural costs were reduced by 0.34€ per

  6. 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

  7. Genetical control of mitotic crossing over in yeast

    International Nuclear Information System (INIS)

    Fedorova, I.V.; Marfin, A.B.

    1982-01-01

    Lethal effect of 8 methoxypsoralen (8-MOP) and long-wave ultraviolet radiation (LUR) on diploid and haploid radiosensitive strains of yeast LSaccharomyces cerevisiae has been studied. It is shown that wild type diploids and homozygous with respect to locus rad 2 is considerably more stable than corresponding haploids, while diploid homozygous with respect to rad 54 locus is more sensitive than haploid. Use of the method of repeated irradiation permitted to study capability of radiosensitive diploids to remove 8 MOP-induced DNA photodamages-monoadducts. This process proceeds effectively in the wild type strain and rad 54 rad 54 diploid and was absent in rad 2 rad 2 diploid. Very strong recombinogenous effect of 8-MOP and LUR was discovered when studying mitotic segregation and crossing-over. It is also shown that rad 2 mutation increases slightly and rad 54 mutation decreases sharply frequency of recombination events in yeast cells. It is established by means of the repeated irradiation method that the main contribution to the 8 MOP and LUR recombinogenous effect is made with DNA sutures induced with these agents. Possible participation of different repair systems in the recombination processes induced with 8 MOP and LUR in yeast cells is discussed

  8. 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.

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

    Energy Technology Data Exchange (ETDEWEB)

    Casalegno, A.; Marchesi, R. [Dipartimento di Energia, Politecnico di Milano, Piazza Leonardo da Vinci 32, 20133 Milano (Italy)

    2008-10-15

    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. (author)

  10. Effective Energy Simulation and Optimal Design of Side-lit Buildings with Venetian Blinds

    Science.gov (United States)

    Cheng, Tian

    Venetian blinds are popularly used in buildings to control the amount of incoming daylight for improving visual comfort and reducing heat gains in air-conditioning systems. Studies have shown that the proper design and operation of window systems could result in significant energy savings in both lighting and cooling. However, there is no convenient computer tool that allows effective and efficient optimization of the envelope of side-lit buildings with blinds now. Three computer tools, Adeline, DOE2 and EnergyPlus widely used for the above-mentioned purpose have been experimentally examined in this study. Results indicate that the two former tools give unacceptable accuracy due to unrealistic assumptions adopted while the last one may generate large errors in certain conditions. Moreover, current computer tools have to conduct hourly energy simulations, which are not necessary for life-cycle energy analysis and optimal design, to provide annual cooling loads. This is not computationally efficient, particularly not suitable for optimal designing a building at initial stage because the impacts of many design variations and optional features have to be evaluated. A methodology is therefore developed for efficient and effective thermal and daylighting simulations and optimal design of buildings with blinds. Based on geometric optics and radiosity method, a mathematical model is developed to reasonably simulate the daylighting behaviors of venetian blinds. Indoor illuminance at any reference point can be directly and efficiently computed. They have been validated with both experiments and simulations with Radiance. Validation results show that indoor illuminances computed by the new models agree well with the measured data, and the accuracy provided by them is equivalent to that of Radiance. The computational efficiency of the new models is much higher than that of Radiance as well as EnergyPlus. Two new methods are developed for the thermal simulation of buildings. A

  11. 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.

  12. Blinded versus unblinded estimation of a correlation coefficient to inform interim design adaptations.

    Science.gov (United States)

    Kunz, Cornelia U; Stallard, Nigel; Parsons, Nicholas; Todd, Susan; Friede, Tim

    2017-03-01

    Regulatory authorities require that the sample size of a confirmatory trial is calculated prior to the start of the trial. However, the sample size quite often depends on parameters that might not be known in advance of the study. Misspecification of these parameters can lead to under- or overestimation of the sample size. Both situations are unfavourable as the first one decreases the power and the latter one leads to a waste of resources. Hence, designs have been suggested that allow a re-assessment of the sample size in an ongoing trial. These methods usually focus on estimating the variance. However, for some methods the performance depends not only on the variance but also on the correlation between measurements. We develop and compare different methods for blinded estimation of the correlation coefficient that are less likely to introduce operational bias when the blinding is maintained. Their performance with respect to bias and standard error is compared to the unblinded estimator. We simulated two different settings: one assuming that all group means are the same and one assuming that different groups have different means. Simulation results show that the naïve (one-sample) estimator is only slightly biased and has a standard error comparable to that of the unblinded estimator. However, if the group means differ, other estimators have better performance depending on the sample size per group and the number of groups. © 2016 The Authors. Biometrical Journal Published by WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  13. Blind Separation of Two Users Based on User Delays and Optimal Pulse-Shape Design

    Directory of Open Access Journals (Sweden)

    Poor HVincent

    2010-01-01

    Full Text Available A wireless network is considered, in which two spatially distributed users transmit narrow-band signals simultaneously over the same channel using the same power. User separation is achieved by oversampling the received signal and formulating a virtual multiple-input multiple-output (MIMO system based on the resulting polyphase components. Because of oversampling, high correlations can occur between the columns of the virtual MIMO system matrix which can be detrimental to user separation. A novel pulse-shape waveform design is proposed that results in low correlation between the columns of the system matrix, while it exploits all available bandwidth as dictated by a spectral mask. It is also shown that the use of successive interference cancelation in combination with blind source separation further improves the separation performance.

  14. 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.

  15. 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.

  16. Diagnostic value of lumbar facet joint injection: a prospective triple cross-over study.

    Directory of Open Access Journals (Sweden)

    Uwe Schütz

    Full Text Available The diagnosis "lumbar facet syndrome" is common and often indicates severe lumbar spine surgery procedures. It is doubtful whether a painful facet joint (FJ can be identified by a single FJ block. The aim of this study was to clarify the validity of a single and placebo controlled bilateral FJ blocks using local anesthetics. A prospective single blinded triple cross-over study was performed. 60 patients (31 f, 29 m, mean age 53.2 yrs (22-73 with chronic low back pain (mean pain persistance 31 months, 6 months of conservative treatment without success admitted to a local orthopaedic department for surgical or conservative therapy of chronic LBP, were included in the study. Effect on pain reduction (10 point rating scale was measured. The 60 subjects were divided into six groups with three defined sequences of fluoroscopically guided bilateral monosegmental lumbar FJ test injections in "oblique needle" technique: verum-(local anaesthetic-, placebo-(sodium chloride- and sham-injection. Carry-over and periodic effects were evaluated and a descriptive and statistical analysis regarding the effectiveness, difference and equality of the FJ injections and the different responses was performed. The results show a high rate of non-response, which documents the lack of reliable and valid predictors for a positive response towards FJ blocks. There was a high rate of placebo reactions noted, including subjects who previously or later reacted positively to verum injections. Equivalence was shown among verum vs. placebo and partly vs. sham also. With regard to test validity criteria, a single intraarticular FJ block with local anesthetics is not useful to detect the pain-responsible FJ and therefore is no valid and reliable diagostic tool to specify indication of lumbar spine surgery. Comparative FJ blocks with local anesthetics and placebo-controls have to be interpretated carefully also, because they solely give no proper diagnosis on FJ being main pain

  17. 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.

  18. 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.

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

    DEFF Research Database (Denmark)

    Holbech, Jakob Vormstrup; Otto, Marit; Bach, Flemming W

    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......-three patients were screened for participation and 39 patients entered the study. Thirty-five patients were included in the data analysis. There were no differences in the ratings of pain relief (levetiracetam 2.29 versus placebo 2.28, p=0.979), total pain intensity (levetiracetam 5.5 versus placebo 5.3, p=0......Levetiracetam is an anticonvulsant which is assumed to act by modulating neurotransmitter release via binding to the vesicle protein SV2A. This could have an impact on signaling in the nociceptive system, and a pilot study indicated relief of neuropathic pain with levetiracetam. OBJECTIVES: The aim...

  20. 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...... patient during the capsaicin treatment and precluded the possibility of conducting studies of this type in a blind manner. No preference for capsaicin treatment was found, and micturition and VAS scores were unchanged after treatment with capsaicin. The mean volume of the contents of the bladder at which...... DH first appeared was 175 ml after saline and 195 ml after capsaicin (mean difference 20 ml with a 5% confidence interval from -25 to 65). Bladder biopsies taken 2 weeks after treatment with capsaicin showed more pronounced inflammation, superficial haemorrhage, squamous epithelial metaplasia...

  1. 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.

  2. 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...... 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...

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

    Energy Technology Data Exchange (ETDEWEB)

    Casalegno, Andrea [Dipartimento di Energetica, Politecnico di Milano, Piazza Leonardo da Vinci 32, 20133 Milan (Italy)]. E-mail: andrea.casalegno@polimi.it; Grassini, Paolo [Dipartimento di Energetica, Politecnico di Milano, Piazza Leonardo da Vinci 32, 20133 Milan (Italy)]. E-mail: PGrassini@seal.it; Marchesi, Renzo [Dipartimento di Energetica, Politecnico di Milano, Piazza Leonardo da Vinci 32, 20133 Milan (Italy)]. E-mail: renzo.marchesi@polimi.it

    2007-03-15

    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.

  4. 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

  5. Intraileal casein infusion increases plasma concentrations of amino acids in humans: A randomized cross over trial.

    Science.gov (United States)

    Ripken, Dina; van Avesaat, Mark; Troost, Freddy J; Masclee, Ad A; Witkamp, Renger F; Hendriks, Henk F

    2017-02-01

    Activation of the ileal brake by casein induces satiety signals and reduces energy intake. However, adverse effects of intraileal casein administration have not been studied before. These adverse effects may include impaired amino acid digestion, absorption and immune activation. To investigate the effects of intraileal infusion of native casein on plasma amino acid appearance, immune activation and gastrointestinal (GI) symptoms. A randomized single-blind cross over study was performed in 13 healthy subjects (6 male; mean age 26 ± 2.9 years; mean body mass index 22.8 ± 0.4 kg/m -2 ), who were intubated with a naso-ileal feeding catheter. Thirty minutes after intake of a standardized breakfast, participants received an ileal infusion, containing either control (C) consisting of saline, a low-dose (17.2 kcal) casein (LP) or a high-dose (51.7 kcal) of casein (HP) over a period of 90 min. Blood samples were collected for analysis of amino acids (AAs), C-reactive protein (CRP), pro-inflammatory cytokines and oxylipins at regular intervals. Furthermore, GI symptom questionnaires were collected before, during and after ileal infusion. None of the subjects reported any GI symptoms before, during or after ileal infusion of C, LP and HP. Plasma concentrations of all AAs analyzed were significantly increased after infusion of HP as compared to C (p casein, respectively. Ileal casein infusion did not affect plasma concentrations of CRP, IL-6, IL-8, IL-1β and TNF-α. Infusion of HP resulted in a decreased concentration of 11,12-dihydroxyeicosatrienoic acid whereas none of the other oxylipins analyzed were affected. A single intraileal infusion of native casein results in a concentration and time dependent increase of AAs in plasma, suggesting an effective digestion and absorption of AAs present in casein. Also, ileal infusion did not result in immune activation nor in GI symptoms. CLINICALTRIALS.GOV: NCT01509469. Copyright © 2016 The Authors. Published by Elsevier

  6. 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.

  7. Fish oil-supplementation increases appetite in healthy adults. A randomized controlled cross-over trial.

    Science.gov (United States)

    Damsbo-Svendsen, Signe; Rønsholdt, Mia Dybkjær; Lauritzen, Lotte

    2013-07-01

    Marine n-3 fatty acids are hypothesized to have beneficial effects on obesity and cancer cachexia possibly via an effect on appetite. The aim of this study was to investigate, if fish oil-supplementation affects appetite in healthy individuals. In a randomized cross-over study, 20 normal-weight subjects (50% females) were given ten 0.5-mL capsules/day of fish oil or soybean oil for 3 weeks separated by 1-week wash-out. In the end of each period, appetite was assessed by 10-cm visual analog scales immediately before and after a standardized breakfast. Results were analyzed in accordance with the paired design considering oil sequence and gender. All subjects completed both periods with a compliance of 96% and oil sequence did not affect the results. There was no difference between the two supplements in any pre-breakfast appetite scores, but the post-prandial sensation of being full was 1.21 cm (0.20; 2.22) lower after the fish oil-period. Furthermore, there was a supplement × gender-interaction on "desire to eat more" due to a score increase of 1.09 cm (0.28; 1.90) in women only. These results suggest that marine n-3 fatty acid may increase appetite. This finding would be potentially beneficial for patients with compromised nutritional status. Copyright © 2013 Elsevier Ltd. All rights reserved.

  8. Nonhomologous Synapsis and Reduced Crossing over in a Heterozygous Paracentric Inversion in Saccharomyces Cerevisiae

    Science.gov (United States)

    Dresser, M. E.; Ewing, D. J.; Harwell, S. N.; Coody, D.; Conrad, M. N.

    1994-01-01

    Homologous chromosome synapsis (``homosynapsis'') and crossing over are well-conserved aspects of meiotic chromosome behavior. The long-standing assumption that these two processes are causally related has been challenged recently by observations in Saccharomyces cerevisiae of significant levels of crossing over (1) between small sequences at nonhomologous locations and (2) in mutants where synapsis is abnormal or absent. In order to avoid problems of local sequence effects and of mutation pleiotropy, we have perturbed synapsis by making a set of isogenic strains that are heterozygous and homozygous for a large chromosomal paracentric inversion covering a well marked genetic interval and then measured recombination. We find that reciprocal recombination in the marked interval in heterozygotes is reduced variably across the interval, on average to ~55% of that in the homozygotes, and that positive interference still modulates crossing over. Cytologically, stable synapsis across the interval is apparently heterologous rather than homologous, consistent with the interpretation that stable homosynapsis is required to initiate or consummate a large fraction of the crossing over observed in wild-type strains. When crossing over does occur in heterozygotes, dicentric and acentric chromosomes are formed and can be visualized and quantitated on blots though not demonstrated in viable spores. We find that there is no loss of dicentric chromosomes during the two meiotic divisions and that the acentric chromosome is recovered at only 1/3 to 1/2 of the expected level. PMID:7851761

  9. Using environmental engineering to increase hand hygiene compliance: a cross-over study protocol.

    Science.gov (United States)

    Schmidtke, Kelly Ann; Aujla, Navneet; Marshall, Tom; Hussain, Abid; Hodgkinson, Gerard P; Arheart, Kristopher; Marti, Joachim; Birnbach, David J; Vlaev, Ivo

    2017-09-11

    Compliance with hand hygiene recommendations in hospital is typically less than 50%. Such low compliance inevitably contributes to hospital-acquired infections that negatively affect patients' well-being and hospitals' finances. The design of the present study is predicated on the assumption that most people who fail to clean their hands are not doing so intentionally, they just forget. The present study will test whether psychological priming can be used to increase the number of people who clean their hands on entering a ward. Here, we present the protocol for this study. The study will use a randomised cross-over design. During the study, each of four wards will be observed during four conditions: olfactory prime, visual prime, both primes and neither prime. Each condition will be experienced for 42 days followed by a 7-day washout period (total duration of trial=189 days). We will record the number of people who enter each ward and whether they clean their hands during observation sessions, the amount of cleaning material used from the dispensers each week and the number of hospital-acquired infections that occur in each period. The outcomes will be compared using a regression analysis. Following the initial trail, the most effective priming condition will be rolled out for 3 months in all the wards. Research ethics approval was obtained from the South Central-Oxford C Research Ethics Committee (16/SC/0554), the Health Regulatory Authority and the sponsor. ISRCTN (15397624); Edge ID 86357. © 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.

  10. Whole grain-rich diet reduces body weight and systemic low-grade inflammation without inducing major changes of the gut microbiome: a randomised cross-over trial

    DEFF Research Database (Denmark)

    Roager, Henrik Munch; Vogt, Josef Korbinian; Kristensen, Mette

    2017-01-01

    Objective To investigate whether a whole grain diet alters the gut microbiome and insulin sensitivity, as well as biomarkers of metabolic health and gut functionality. Design 60 Danish adults at risk of developing metabolic syndrome were included in a randomised cross-over trial with two 8-week d...

  11. 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.

  12. Effect of aggregation form on bioavailability of zeaxanthin in humans: a randomised cross-over study.

    Science.gov (United States)

    Hempel, Judith; Fischer, Anja; Fischer, Monique; Högel, Josef; Bosy-Westphal, Anja; Carle, Reinhold; Schweiggert, Ralf M

    2017-11-01

    Carotenoid bioavailability from plant and animal food is highly variable depending on numerous factors such as the physical deposition form of carotenoids. As the carotenoid zeaxanthin is believed to play an important role in eye and brain health, we sought to compare the human bioavailability of an H-aggregated with that of a J-aggregated deposition form of zeaxanthin encapsulated into identical formulation matrices. A randomised two-way cross-over study with sixteen participants was designed to compare the post-prandial bioavailability of an H-aggregated zeaxanthin and a J-aggregated zeaxanthin dipalmitate formulation, both delivering 10 mg of free zeaxanthin. Carotenoid levels in TAG-rich lipoprotein fractions were analysed over 9·5 h after test meal consumption. Bioavailability from the J-aggregated formulation (AUC=55·9 nmol h/l) was 23 % higher than from the H-aggregated one (AUC=45·5 nmol h/l), although being only marginally significant (P=0·064). Furthermore, the same formulations were subjected to an internationally recognised in vitro digestion protocol to reveal potential strengths and weaknesses of simulated digestions. In agreement with our human study, liberation of zeaxanthin from the J-aggregated formulation into the simulated duodenal fluids was superior to that from the H-aggregated form. However, micellization rate (bioaccessibility) of the J-aggregated zeaxanthin dipalmitate was lower than that of the H-aggregated zeaxanthin, being contradictory to our in vivo results. An insufficient ester cleavage during simulated digestion was suggested to be the root cause for these observations. In brief, combining our in vitro and in vivo observations, the effect of the different aggregation forms on human bioavailability was lower than expected.

  13. 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 wit...... cognitive tests of psychomotor speed and attention. Furthermore subjective scores of depression and drowsiness were significantly improved by modafinil.......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...... 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=

  14. Effects of adding chymosin to milk on calcium homeostasis: a randomized, double-blind, cross-over study

    DEFF Research Database (Denmark)

    Liendgaard, Ulla Kristine Møller; Jensen, L.T.; Mosekilde, Leif

    2015-01-01

    either chymosin or similar placebo was added. Compared with placebo, chymosin did not affect 24-h urinary calcium, calcium/creatinine ratio, plasma parathyroid hormone, calcitonin or ionized calcium levels. However, during the first 4 h after intake of milk with chymosin, urinary calcium-creatinine ratio...... was significantly increased (17%) compared with placebo. Stratification by daily calcium intake showed effect of chymosin in participant with a habitual intake above the median (>1,050 mg/day) in whom both urinary calcium and calcium/creatinine ratio were significantly increased compared with placebo. Effects did...

  15. 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

  16. The cross-over points in lattice gauge theories with continuous gauge groups

    International Nuclear Information System (INIS)

    Cvitanovic, P.; Greensite, J.; Lautrup, B.

    1981-01-01

    We obtain a closed expression for the weak-to-strong coupling cross-over point in all Wilson type lattice gauge theories with continuous gauge groups. We use a weak-coupling expansion of the mean-field self-consistency equation. In all cases where our results can be compared with Monte Carlo calculations the agreement is excellent. (orig.)

  17. 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

  18. 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 ...

  19. 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

  20. 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

  1. 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.

  2. An improved design for AlGaN solar-blind avalanche photodiodes with enhanced avalanche ionization

    International Nuclear Information System (INIS)

    Tang Yin; Cai Qing; Chen Dun-Jun; Lu Hai; Zhang Rong; Zheng You-Dou; Yang Lian-Hong; Dong Ke-Xiu

    2017-01-01

    To enhance the avalanche ionization, we designed a new separate absorption and multiplication AlGaN solar-blind avalanche photodiode (APD) by using a high/low-Al-content AlGaN heterostructure as the multiplication region instead of the conventional AlGaN homogeneous layer. The calculated results show that the designed APD with Al 0.3 Ga 0.7 N/Al 0.45 Ga 0.55 N heterostructure multiplication region exhibits a 60% higher gain than the conventional APD and a smaller avalanche breakdown voltage due to the use of the low-Al-content Al 0.3 Ga 0.7 N which has about a six times higher hole ionization coefficient than the high-Al-content Al 0.45 Ga 0.55 N. Meanwhile, the designed APD still remains a good solar-blind characteristic by introducing a quarter-wave AlGaN/AlN distributed Bragg reflectors structure at the bottom of the device. (paper)

  3. The CRO-1 gene of Saccharomyces cerevisiae controls mitotic crossing over, chromosomal stability and sporulation

    International Nuclear Information System (INIS)

    Esposito, M.S.; Maleas, D.T.; Bjornstad, K.A.; Holbrook, L.L.

    1987-01-01

    The properties of a novel temperature-sensitive recombination-defective mutant of Saccharomyces cerevisiae, cro1-1 is described. The cro1-1 mutant is the first instance of a rec mutation that reduces drastically the rates of spontaneous mitotic crossing-over events but not those of gene conversional events. The cro1-1 mutation thus provides evidence that mitotic crossing-over is dependent upon gene products that are not essential for gene conversional events. The cro1-1 mutation also results in enhanced mitotic-chromosomal instability and MATa/MATα cro1-1/cro1-1 mutants are sporulation deficient. These phenotypes indicate that the CRO1 gene modulates mitotic chromosomal integrity and is essential for normal meiosis. The cro1-1 mutant possesses Holliday junction resolvase activity, hence its recombinational defect does not involve failure to execute this putative final recombinational step. 7 refs., 1 fig., 5 tabs

  4. Genetic control of mitotic crossing over in yeast. 2. Influence of UV irradiation

    International Nuclear Information System (INIS)

    Zakharov, I.A.; Marfin, S.V.; Koval'tsova, S.V.; Kasinova, G.V.

    1982-01-01

    UV-induced crossing-over and general mitotic segregation of the following strains of Saccharomyces cerevisiae yeasts were studied: a wild-type diploid, diploids homozygous with respect to the radiosensitivity of rad 2, rad 15, rad 54, xrs 4, rad 2 rad 54, rad 15 rad 54. Wild-type diploids rad 2 and rad 15 have a high frequency of the induced mitotic crossing-over. Diploids rad 15, rad 54 can not cause UV-induced mitotic crossing-over. Reddish-pink and reddish-pink-white colonies ratio (the first appear if the crossing-over occurs during the first after the irradiation division, the second - during the second division) is 4.8:1 for the wild type, 1.6:1 for rad 2, and 1.1:1 for rad 15. Nonreciprocal mitotic segregation of high frequency was observed for the wild type rad 2, rad 15, xrs 4, and diploids rad 54, rad 2 rad 54, rad 15 rad 54 had a lower frequency. We suppose that after UV-irradiation there exist at least three types of repair in yeast diploid cells: excision repair, prereplication recombinating repair after the excision of dimers, and post-replication recombinating repair. Rad 2 and rad 15 mutations blow the first and second types, rad 54 mutation partially block the second and third parths. It seems that xrs 4 mutation does not block the recombinating capability but somehow changes the process of recombination in such a way that much nonreciprocal products recorded as seqregants are produced [ru

  5. 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.

  6. Design of nanophotonic, hot-electron solar-blind ultraviolet detectors with a metal-oxide-semiconductor structure

    International Nuclear Information System (INIS)

    Wang, Zhiyuan; Wang, Xiaoxin; Liu, Jifeng

    2014-01-01

    Solar-blind ultraviolet (UV) detection refers to photon detection specifically in the wavelength range of 200 nm–320 nm. Without background noises from solar radiation, it has broad applications from homeland security to environmental monitoring. The most commonly used solid state devices for this application are wide band gap (WBG) semiconductor photodetectors (Eg > 3.5 eV). However, WBG semiconductors are difficult to grow and integrate with Si readout integrated circuits (ROICs). In this paper, we design a nanophotonic metal-oxide-semiconductor structure on Si for solar-blind UV detectors. Instead of using semiconductors as the active absorber, we use Sn nano-grating structures to absorb UV photons and generate hot electrons for internal photoemission across the Sn/SiO 2 interfacial barrier, thereby generating photocurrent between the metal and the n-type Si region upon UV excitation. Moreover, the transported hot electron has an excess kinetic energy >3 eV, large enough to induce impact ionization and generate another free electron in the conduction band of n-Si. This process doubles the quantum efficiency. On the other hand, the large metal/oxide interfacial energy barrier (>3.5 eV) also enables solar-blind UV detection by blocking the less energetic electrons excited by visible photons. With optimized design, ∼75% UV absorption and hot electron excitation can be achieved within the mean free path of ∼20 nm from the metal/oxide interface. This feature greatly enhances hot electron transport across the interfacial barrier to generate photocurrent. The simple geometry of the Sn nano-gratings and the MOS structure make it easy to fabricate and integrate with Si ROICs compared to existing solar-blind UV detection schemes. The presented device structure also breaks through the conventional notion that photon absorption by metal is always a loss in solid-state photodetectors, and it can potentially be extended to other active metal photonic devices. (paper)

  7. 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...

  8. 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.

  9. 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.

  10. [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.

  11. Effect of breathing oxygen-enriched air on exercise performance in patients with precapillary pulmonary hypertension: randomized, sham-controlled cross-over trial.

    Science.gov (United States)

    Ulrich, Silvia; Hasler, Elisabeth D; Saxer, Stéphanie; Furian, Michael; Müller-Mottet, Séverine; Keusch, Stephan; Bloch, Konrad E

    2017-04-14

    The purpose of the current trial was to test the hypothesis that breathing oxygen-enriched air increases exercise performance of patients with pulmonary arterial or chronic thrombo-embolic pulmonary hypertension (PAH/CTEPH) and to investigate involved mechanisms. Twenty-two patients with PAH/CTEPH, eight women, means ± SD 61 ± 14 years, resting mPAP 35 ± 9mmHg, PaO2 ambient air >7.3 kPa, underwent four bicycle ergospirometries to exhaustion on different days, while breathing oxygen-enriched (FiO2 0.50, hyperoxia) or ambient air (FiO2 0.21, normoxia) using progressively increased or constant load protocols (with 75% maximal work rate under FiO2 0.21), according to a randomized, sham-controlled, single-blind, cross-over design. ECG, pulmonary gas-exchange, arterial blood gases, cerebral and quadriceps muscle tissue oxygenation (CTO and QMTO) by near-infrared spectroscopy were measured. In ramp exercise, maximal work rate increased from 113 ± 38 W with normoxia to 132 ± 48 W with hyperoxia, mean difference 19.7 (95% CI 10.5-28.9) W, P endurance increased from 571 ± 443 to 1242 ± 514 s, mean difference 671 (95% CI 392-951) s, P < 0.001. At end-exercise with hyperoxia PaO2, CTO, QMTO, and PaCO2 were increased, and ventilatory equivalents for CO2 were reduced while the physiological dead space/tidal volume ratio remained unchanged. In patients with PAH/CTEPH, breathing oxygen-enriched air provides major increases in exercise performance. This is related to an improved arterial oxygenation that promotes oxygen availability in muscles and brain and to a reduction of the excessive ventilatory response to exercise thereby enhancing ventilatory efficiency. Patients with PAH/CTEPH may therefore benefit from oxygen therapy during daily physical activities and training. clinicaltrials.gov Identifier: NCT01748474. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions

  12. 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

  13. 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 < 0.0001) and PPT (p = 0.0007), with the massage group experiencing reduced 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

  14. 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.

  15. Vascular provisions for a local utero-ovarian cross-over pathway in new world camelids.

    Science.gov (United States)

    Del Campo, M R; Del Campo, C H; Ginther, O J

    1996-10-15

    The right uterine horn of alpacas causes luteolysis in the right ovary, whereas the left horn causes luteolysis in both ovaries. Female reproductive tracts were studied in 32 adult llamas, 12 adult alpacas, and 21 mid-gestation female fetuses to determine if there is a dichotomy in the vascular anatomy between the 2 sides. Adult tracts were studied by either injection of colored latex into the veins and arteries followed by tissue clearing or by injection of colored fluids during transillumination. Fetal uteri were studied by transillumination. The angioarchitecture of the ovarian vascular pedicle was similar to that reported for ewes. There was no vessel comparable to the middle uterine artery, which is the largest uterine artery in the other farm species. A striking difference from the uterine vascular of other farm species was the presence of a major branch of the right uterine artery that crossed the cranial intercornual area to supply much of the left uterine horn. A corresponding major vein originated from the left horn, crossed the mid-line, and terminated as a branch of the right uterine vein. Thus, the vascular anatomy indicated that much venous blood from the left horn drained to the right side. This was confirmed by injection of colored fluid into a small venous branch at the tip of the left horn. The prominent cross-over vessels were observed in the fetal uteri, and the diameter of the left uterine fetal horn (6.7 +/- 0.6 mm) was greater (P blood from the left horn into an artery supplying the right ovary was not defined in this study. However, the results provide an anatomical basis for functional testing of the cross-over hypothesis and defining the area of venoarterial transfer in camelids.

  16. Effectiveness of Different Bristle Designs of Toothbrushes and Periodontal Status among Fixed Orthodontic Patients: A Double-blind Crossover Design.

    Science.gov (United States)

    Naik, Sandhya P; Punathil, Sameer; Shetty, Praveena; Jayanti, Ipsita; Jalaluddin, Md; Avijeeta, Anisha

    2018-02-01

    The aim of the present study was to evaluate the effectiveness of different bristle designs of toothbrushes and the periodontal status among patients undergoing fixed orthodontic treatment. This randomized controlled trial (RCT) consisted of 45 adolescents (comprising 20 males and 25 females) undergoing fixed orthodontic treatment. The study participants were randomly allocated to three groups, each group being assigned a locally available toothbrush with a particular design of toothbrush bristle. In the first test phase, group I study participants were allocated to toothbrush with flat bristles, group II study subjects were allocated to toothbrush with zigzag bristles, and group III study participants were allocated to toothbrush with crisscross bristles. The study participants were recalled after 4 weeks to check the effectiveness of the allocated toothbrushes. A washout period of 1 week was maintained to ensure that there was no carryover effect of the different bristle designs. In the second test phase, each patient used the opposite toothbrush bristle design (group I: toothbrush with zigzag bristles, group II: toothbrush with crisscross bristles, and group III: toothbrush with flat bristles). Plaque scores were measured using Turesky-Gilmore-Glickman modification of Quigley-Hein plaque index (PI). In both phase 1 and 2 of this RCT, toothbrush with crisscross bristles exhibited maximum plaque reduction among the three different bristle design toothbrushes following 30 days (p = 0.312 ± 0.102 and 0.280 ± 0.110, respectively), which was statistically significant. It was concluded that all the three designs of toothbrushes were effective in removing plaque in patients with fixed orthodontic appliances. But among the three different toothbrushes, toothbrush with crisscross bristles showed the highest mean plaque reduction. Plaque accumulation around the orthodontic brackets and gingival margins is quite common among the fixed orthodontic patients, who encounter

  17. Flexible chain molecules in the marginal and concentrated regimes: universal static scaling laws and cross-over predictions

    OpenAIRE

    Laso Carbajo, Manuel; Karayiannis, Nikos Ch.

    2008-01-01

    We present predictions for the static scaling exponents and for the cross-over polymer volumetric fractions in the marginal and concentrated solution regimes. Corrections for finite chain length are made. Predictions are based on an analysis of correlated fluctuations in density and chain length, in a semigrand ensemble in which mers and solvent sites exchange identities. Cross-over volumetric fractions are found to be chain length independent to first order, although reciprocal-N corrections...

  18. Effects of Subsensory Noise and Fatigue on Knee Landing and Cross-over Cutting Biomechanics in Male Athletes.

    Science.gov (United States)

    Qu, Xingda; Jiang, Jianxin; Hu, Xinyao

    2018-06-01

    The objective of this study was to examine the effects of subsensory noise and fatigue on knee biomechanics during the athletic task of landing followed by cross-over cutting. A total of 32 healthy male athletes participated in the study. They were evenly divided into 2 groups: no fatigue group and fatigue group. Fatigue was induced to the lower extremity by a repetitive squatting exercise in the fatigue group. Subsensory 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 cross-over cutting in both the subsensory on and off conditions. Dependent variables were selected to assess knee biomechanics in the phases of landing and cross-over cutting, separately. Results showed that fatigue resulted in larger knee flexion during landing and larger knee internal rotation during cross-over cutting. Subsensory noise was found to reduce knee rotation impulse during cross-over cutting. These findings suggest that cross-over cutting is more dangerous than landing in the fatigue condition, and subsensory noise may lead to changes in knee biomechanics consistent with reduced risk of anterior cruciate ligament injuries, but the changes may be task-specific.

  19. A randomized, controlled cross-over trial of dermally-applied lavender (Lavandula angustifolia) oil as a treatment of agitated behaviour in dementia.

    Science.gov (United States)

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

    2013-11-13

    Lavender essential oil shows evidence of sedative properties in neurophysiological and animal studies but clinical trials of its effectiveness as a treatment of agitation in people with dementia have shown mixed results. Study methods have varied widely, however, making comparisons hazardous. To help remedy previous methodological shortcomings, we delivered high grade lavender oil in specified amounts to nursing home residents whose agitated behaviours were recorded objectively. 64 nursing home residents with frequent physically agitated behaviours were entered into a randomized, single-blind cross-over trial of dermally-applied, neurophysiologically active, high purity 30% lavender oil versus an inactive control oil. A blinded observer counted the presence or absence of target behaviours and rated participants' predominant affect during each minute for 30 minutes prior to exposure and for 60 minutes afterwards. Lavender oil did not prove superior to the control oil in reducing the frequency of physically agitated behaviours or in improving participants' affect. Studies of essential oils are constrained by their variable formulations and uncertain pharmacokinetics and so optimal dosing and delivery regimens remain speculative. Notwithstanding this, topically delivered, high strength, pure lavender oil had no discernible effect on affect and behaviour in a well-defined clinical sample. Australian and New Zealand Clinical Trials Registry (ACTRN 12609000569202).

  20. 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.

  1. 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.

  2. 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.)

  3. Crossing Over from Attractive to Repulsive Interactions in a Tunneling Bosonic Josephson Junction.

    Science.gov (United States)

    Spagnolli, G; Semeghini, G; Masi, L; Ferioli, G; Trenkwalder, A; Coop, S; Landini, M; Pezzè, L; Modugno, G; Inguscio, M; Smerzi, A; Fattori, M

    2017-06-09

    We explore the interplay between tunneling and interatomic interactions in the dynamics of a bosonic Josephson junction. We tune the scattering length of an atomic ^{39}K Bose-Einstein condensate confined in a double-well trap to investigate regimes inaccessible to other superconducting or superfluid systems. In the limit of small-amplitude oscillations, we study the transition from Rabi to plasma oscillations by crossing over from attractive to repulsive interatomic interactions. We observe a critical slowing down in the oscillation frequency by increasing the strength of an attractive interaction up to the point of a quantum phase transition. With sufficiently large initial oscillation amplitude and repulsive interactions, the system enters the macroscopic quantum self-trapping regime, where we observe coherent undamped oscillations with a self-sustained average imbalance of the relative well population. The exquisite agreement between theory and experiments enables the observation of a broad range of many body coherent dynamical regimes driven by tunable tunneling energy, interactions and external forces, with applications spanning from atomtronics to quantum metrology.

  4. 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.)

  5. CSR Interaction at the Cross-Over of the Full Compression Point

    International Nuclear Information System (INIS)

    Rui Li

    2005-01-01

    In recent commissioning of the 10 kW FEL at Jefferson Lab, as one varies the energy chirp of the electron bunches at the entrance of the chicane to make the bunch more and more compressed at the exit of the chicane, a sudden increase in the energy spread is observed [1] at the crossover of the full compression point. This phenomenon is accompanied simultaneously with a significant increase of the THz radiation from the electron beam. A similar observation was made earlier in the CTF II CSR experiment at CERN [2]. For example, for 5 nC bunch charge, ''the mean momentum spread increased by a factor of 4 at full compression with respect to the initial spread, and decreased to a factor of 3 larger than the initial spread at overcompression''. There is also a sudden drop of mean momentum at the full compression, along with a sudden increase in the horizontal emittance (see Fig. 5 of [2]). As a first step to understand this phenomenon, in this paper, we analyze the effective longitudinal CSR force using our recent formulation of CSR dynamics [3], and show there is a sudden increase in the magnitude of the effective longitudinal CSR force at the cross-over of the full compression point. A numerical example is given for an LCLS type chicane. The physical picture of this sudden increase is also discussed

  6. Can inhibitory and facilitatory kinesiotaping techniques affect motor neuron excitability? A randomized cross-over trial.

    Science.gov (United States)

    Yoosefinejad, Amin Kordi; Motealleh, Alireza; Abbasalipur, Shekoofeh; Shahroei, Mahan; Sobhani, Sobhan

    2017-04-01

    The aim of this study was to investigate the immediate effects of facilitatory and inhibitory kinesiotaping on motor neuron excitability. Randomized cross-over trial. Twenty healthy people received inhibitory and facilitatory kinesiotaping on two testing days. The H- and M-waves of the lateral gasterocnemius were recorded before and immediately after applying the two modes of taping. The Hmax/Mmax ratio (a measure of motor neuron excitability) was determined and analyzed. The mean Hmax/Mmax ratios were -0.013 (95% CI: -0.033 to 0.007) for inhibitory taping and 0.007 (95% CI: -0.013 to 0.027) for facilitatory taping. The mean difference between groups was -0.020 (95% CI: -0.048 to 0.008). The statistical model revealed no significant differences between the two interventions (P = 0.160). Furthermore, there were no within-group differences in Hmax/Mmax ratio for either group. Our findings did not disclose signs of immediate change in motor neuron excitability in the lateral gasterocnemius. Copyright © 2016. Published by Elsevier Ltd.

  7. 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

  8. Variation and Evolution of the Meiotic Requirement for Crossing Over in Mammals.

    Science.gov (United States)

    Dumont, Beth L

    2017-01-01

    The segregation of homologous chromosomes at the first meiotic division is dependent on the presence of at least one well-positioned crossover per chromosome. In some mammalian species, however, the genomic distribution of crossovers is consistent with a more stringent baseline requirement of one crossover per chromosome arm. Given that the meiotic requirement for crossing over defines the minimum frequency of recombination necessary for the production of viable gametes, determining the chromosomal scale of this constraint is essential for defining crossover profiles predisposed to aneuploidy and understanding the parameters that shape patterns of recombination rate evolution across species. Here, I use cytogenetic methods for in situ imaging of crossovers in karyotypically diverse house mice (Mus musculus domesticus) and voles (genus Microtus) to test how chromosome number and configuration constrain the distribution of crossovers in a genome. I show that the global distribution of crossovers in house mice is thresholded by a minimum of one crossover per chromosome arm, whereas the crossover landscape in voles is defined by a more relaxed requirement of one crossover per chromosome. I extend these findings in an evolutionary metaanalysis of published recombination and karyotype data for 112 mammalian species and demonstrate that the physical scale of the genomic crossover distribution has undergone multiple independent shifts from one crossover per chromosome arm to one per chromosome during mammalian evolution. Together, these results indicate that the chromosomal scale constraint on crossover rates is itself a trait that evolves among species, a finding that casts light on an important source of crossover rate variation in mammals. Copyright © 2017 by the Genetics Society of America.

  9. Randomized cross-over trial of polyethylene glycol electrolyte solution and water for colostomy irrigation.

    Science.gov (United States)

    O'Bichere, Austin; Green, Colin; Phillips, Robin K S

    2004-09-01

    Water for colostomy irrigation is largely absorbed by the colon, which may result in less efficient expulsion of stool. This study compared the outcome of colonic cleansing with water and polyethylene glycol solution. In a cross-over study, 41 colostomy irrigators were randomly assigned to water or polyethylene glycol solution irrigation first and then the other regimen, each for one week. Patients recorded fluid inflow time, total washout time, cramps, leakage episodes, number of stoma pouches used, and satisfaction scores (Visual Analog Scale, 1-10: 1 = poor, and 10 = excellent). The median and interquartile range for each variable was calculated, and the two treatments were compared (Wilcoxon's test). Eight patients failed to complete the study. Thirty-three patients (20 females; mean age, 55 (range, 39-73) years) provided 352 irrigation sessions: water (n = 176), and polyethylene glycol solution (n = 176). Irrigation was performed every 24, 48, and 72 hours by 17, 9, and 7 patients respectively, using 500 ml (n = 1), 750 ml (n = 2), 1,000 ml (n = 16), 1,500 ml (n = 11), 2,000 ml (n = 2), and 3,500 ml (n = 1) of fluid. The median and interquartile range for water vs. polyethylene glycol solution were: fluid inflow time (6 (range, 4.4-10.8) vs. 6.3 (range, 4.1-11) minutes; P = 0.48), total washout time (53 (range, 33-69) vs. 38 (range, 28-55) minutes; P = 0.01), leakage episodes (2.3 (range, 1.7-3.8) vs. 0.7 (range, 0.2-1); P colostomy irrigation.

  10. What is Color Blindness?

    Science.gov (United States)

    ... Color Blindness? Who Is at Risk for Color Blindness? Color Blindness Causes Color Blindness Diagnosis and Treatment How Color Blindness Is Tested What Is Color Blindness? Leer en Español: ¿Qué es el daltonismo? Written ...

  11. 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

  12. 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 (ppeas) 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

  13. 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.

  14. Randomized cross-over trial of ventilator modes during non-invasive ventilation titration in amyotrophic lateral sclerosis.

    Science.gov (United States)

    Vrijsen, Bart; Buyse, Bertien; Belge, Catharina; Vanpee, Goele; Van Damme, Philip; Testelmans, Dries

    2017-08-01

    Non-invasive ventilation (NIV) improves survival, quality of life and sleep in patients with amyotrophic lateral sclerosis (ALS). Nevertheless, NIV titration is conducted in different ways. We aim to provide more insight into NIV titration by comparing the effects of a spontaneous (S) and spontaneous-timed (ST) modes on gas exchange, sleep architecture and patient-ventilator asynchronies (PVAs). After an initial night of NIV titration, patients were randomized to S or ST mode in a cross-over design. NIV was titrated using polysomnography, oximetry (oxygen saturation, SpO 2 %) and transcutaneous carbon dioxide (PtcCO 2 ) measurement. PVAs were analysed breath-by-breath. Thirteen patients were analysed after inclusion. ST mode showed better results in gas exchange (minimal SpO 2 %: 83 (80-89)% vs 87 (84-89)%; oxygen desaturation index: 15 (5-28)/h sleep vs 7 (3-9)/h sleep; PtcCO 2 >55 mm Hg: 20 (0-59)% vs 0 (0-27)% total sleep time for S and ST mode, respectively, all P < 0.05) and respiratory events (obstructive: 8.9 (1.2-18.3)/h sleep vs 1.8 (0.3-4.9)/h sleep and central: 2.6 (0.4-14.1)/h sleep vs 0.2 (0.0-1.1)/h sleep for S and ST mode, respectively, both P < 0.01). No differences in sleep architecture were found. Ineffective efforts and respiratory events were more frequently present in S mode. Nevertheless, four patients were discharged on S mode as these patients showed clinically better results for sleep architecture and PVA during the night on S mode. ST mode shows better results in gas exchange, respiratory events and PVA. Nevertheless, accurate NIV titration remains necessary as some patients show equal or better results when using the S mode. © 2017 Asian Pacific Society of Respirology.

  15. 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.

  16. 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.

  17. 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

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

    Directory of Open Access Journals (Sweden)

    Knobe Matthias

    2012-09-01

    Full Text Available Abstract 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 Conclusions The additional implementation of arthroscopy tutorials to the dissection course during the undergraduate anatomy training is profitable and attractive to students with respect to complex joint anatomy. Simultaneous

  19. 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...

  20. 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...

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

    Science.gov (United States)

    Holm, Bente; Husted, Henrik; Kehlet, Henrik; Bandholm, Thomas

    2012-08-01

    To investigate the acute effect of knee joint icing on knee extension strength and knee pain in patients shortly after total knee arthroplasty. A prospective, single-blinded, randomized, cross-over study. A fast-track orthopaedic arthroplasty unit at a university hospital. Twenty patients (mean age 66 years; 10 women) scheduled for primary unilateral total knee arthroplasty. 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 minutes of elbow icing (control treatment). The order of treatments was randomized. Maximal knee extension strength (primary outcome), knee pain at rest and knee pain during the maximal knee extensions were measured 2-5 minutes before and 2-5 minutes after both treatments by an assessor blinded for active or control treatment. The change in knee extension strength associated with knee icing was not significantly different from that of elbow icing (knee icing change (mean (1 SD)) -0.01 (0.07) Nm/kg, elbow icing change -0.02 (0.07) Nm/kg, P = 0.493). Likewise, the changes 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. In contrast to observations in experimental knee effusion models and inflamed knee joints, knee joint icing for 30 minutes shortly after total knee arthroplasty had no acute effect on knee extension strength or knee pain.

  2. 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 salivary 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.

  3. Influence of erythropoietin on cognitive performance during experimental hypoglycemia in patients with type 1 diabetes mellitus: a randomized cross-over trial.

    Directory of Open Access Journals (Sweden)

    Peter Lommer Kristensen

    Full Text Available The incidence of severe hypoglycemia in type 1 diabetes has not decreased over the past decades. New treatment modalities minimizing the risk of hypoglycemic episodes and attenuating hypoglycemic cognitive dysfunction are needed. We studied if treatment with the neuroprotective hormone erythropoietin (EPO enhances cognitive function during hypoglycemia.Eleven patients with type 1 diabetes, hypoglycemia unawareness and recurrent severe hypoglycemia completed the study. In a double-blind, randomized, balanced, cross-over study using clamped hypoglycemia they were treated with 40,000 IU of EPO or placebo administered intravenously six days before the two experiments. Cognitive function (primary endpoint, hypoglycemic symptoms, and counter-regulatory hormonal response were recorded.Compared with placebo, EPO treatment was associated with a significant reduction in errors in the most complex reaction time task (-4.7 (-8.1 to -1.3, p = 0.01 and a less reaction time prolongation (-66 (-117 to -16 msec, p = 0.02. EPO treatment did not change performance in other measures of cognition. Hypoglycemic symptoms, EEG-changes, and counter-regulatory hormone concentrations did not differ between EPO and placebo treatment.In patients with type 1 diabetes and hypoglycemia unawareness, treatment with EPO is associated with a beneficial effect on cognitive function in a complex reaction time task assessing sustained attention/working memory. Hypoglycemic symptoms and hormonal responses were not changed by EPO treatment.ClinicalTrials.gov NCT00615368.

  4. 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...

  5. Inflammatory response of a new synthetic dialyzer membrane. A randomised cross-over comparison between polysulfone and helixone.

    Science.gov (United States)

    Stefoni, S; Colì, L; Cianciolo, G; Donati, G; Ruggeri, G; Ramazzotti, E; Pohlmeier, R; Lang, D

    2003-01-01

    Hemodialysis patients suffer from chronic inflammation due to intradialytic contact of blood with artificial materials. The FX 60 dialyzer which belongs to the new FX-class series of dialyzers is composed of the new membrane Helixone. This membrane is derived from the original Fresenius Polysulfone membrane. The FX-class design is based on modified geometry of fibres and housing and has resulted in a new dialyzer with improved efficiency, safety and ease of handling compared to the F series (F 60S) dialyzer. The aim of the study was to investigate whether the biocompatibility pattern in terms of inflammatory parameters of the new type of polysulfone dialyzer has changed compared to the standard. A clinical in vivo study was conducted to compare the intradialytic inflammatory response of the two dialyzers, FX 60 and F 60S. Eight chronic dialysis patients were selected for the study: mean age 65.5 +/- 15.5 years, mean time on dialysis 100 +/- 95 months. The randomized cross-over study involved a treatment period of 2 weeks (total 6 sessions), one week with each dialyzer, starting with one or the other according to the randomization scheme. Blood samples were taken at 0 (T0), 15, 60, and 240 minutes to evaluate white blood cell (WBC) count, complement factor C5a, leukocyte elastase, soluble intercellular adhesion molecule 1 (sICAM-1), platelet count, C-reactive protein (CRP). At 15 min, WBC count showed a comparably, low decrease for both dialyzers: -7.6% for FX 60 versus -6.6% for F 60S, p=not significant (ns). At the same time the C5a concentration decreased from 15.0 +/- 7.5 ng/ml to 13.5 +/- 6.7 ng/ml (p=ns) for FX 60, and from 15.1 +/- 12.5 ng/ml to 14.9 +/- 25.0 ng/ml for F 60S (p=ns). The elastase concentration progressively increased over time with no statistical difference between the two dialyzers. The levels of sICAM-1, CRP, and platelet count were similar at each time point for both dialyzers, varying around the baseline values (p=ns). No significant

  6. 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

    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......-over design each comprising two eight-week dietary intervention periods, separated by a six-week wash-out period. Each trial included 60 men and women exhibiting an increased metabolic risk. In the gluten study a gluten-poor diet was compared with a gluten-rich dietary fiber-controlled diet......, and in the wholegrain study a wholegrain-rich diet was compared with a refined grain diet. The control diet was identical in both studies, being concomitantly high in gluten and refined. Participants substituted all cereal products with provided intervention products which they consumed ad libitum. Before and after...

  7. 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

  8. Effect of meal composition on postprandial lipid concentrations and lipoprotein particle numbers: A randomized cross-over study.

    Directory of Open Access Journals (Sweden)

    Meena Shah

    Full Text Available It is unclear how high-protein (HP and high-monounsaturated fat (HMF meals affect postprandial blood lipids and lipoprotein particle numbers (LPN.To compare a HP versus a HMF meal on postprandial lipid and LPN responses.Twenty-four participants (age: 36.3±15.0 years; body mass index: 23.6±2.0 kg/m2; 45.8% female were fed a HP (31.9% energy from protein and a HMF (35.2% fat and 20.7% monounsaturated fat meal in a randomized cross-over trial design. Energy and carbohydrate content were the same across meals. Blood samples were drawn in the fasting state and 3 hour postprandial state, and assessed for lipids and LPN.Repeated measures analysis showed a significant (p<0.05 treatment by time interaction effect for triglycerides (TG, the primary variable, total high-density lipoprotein particles (T-HDLP and T-HDLP minus large-buoyant high-density lipoprotein 2b (T-HDLP-LB-HDL2b. HP versus HMF condition led to significantly lower TG at 120 (geometric mean: 90.1 (95% confidence interval (CI: 76.4-106.3 vs. 146.5 (124.2-172.9 mg/dL and 180 (101.4 (83.1-123.8 vs. 148.7 (121.9-181.4 mg/dL min and higher T-HDLP at 120 (mean difference: 297.3 (95% CI: 48.6-545.9 nmol/L and 180 (291.6 (15.8-567.5 nmol/L min. The difference in T-HDLP by condition was due to the significantly higher small-dense HDLP (T-HDLP-LB-HDL2b during HP versus HMF condition at 120 (mean difference: 452.6 (95% CI: 177.4-727.9 nmol/L and 180 (496.8 (263.1-730.6 nmol/L min. Area under the curve analysis showed that HP versus HMF condition led to significantly lower TG, non-HDLP, and very-low-density lipoprotein particles (VLDLP responses but significantly less favorable responses in LB-HDL2b particles, T-HDLP-LB-HDL2b, and LB-HDL2b/T-HDLP ratio.The HP meal led to lower TG, non-HDLP, and VLDLP but less favorable LB-HDL2b, small-dense HDLP, and LB-HDL2b/T-HDLP ratio responses versus a HMF meal. Further studies are needed to confirm these findings over multiple meals.

  9. 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

  10. 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

  11. Whole grain-rich diet reduces body weight and systemic low-grade inflammation without inducing major changes of the gut microbiome: a randomised cross-over trial

    DEFF Research Database (Denmark)

    Roager, Henrik Munch; Vogt, Josef Korbinian; Kristensen, Mette

    2017-01-01

    Objective To investigate whether a whole grain diet alters the gut microbiome and insulin sensitivity, as well as biomarkers of metabolic health and gut functionality. Design 60 Danish adults at risk of developing metabolic syndrome were included in a randomised cross-over trial with two 8-week...... dietary intervention periods comprising whole grain diet and refined grain diet, separated by a washout period of ≥6 weeks. The response to the interventions on the gut microbiome composition and insulin sensitivity as well on measures of glucose and lipid metabolism, gut functionality, inflammatory...... of whole grain consumed, in particular with intake of rye. Conclusion Compared with refined grain diet, whole grain diet did not alter insulin sensitivity and gut microbiome but reduced body weight and systemic low-grade inflammation....

  12. Enhanced bioavailability of lycopene when consumed as cis-isomers from tangerine compared to red tomato juice, a randomized, cross-over clinical trial.

    Science.gov (United States)

    Cooperstone, Jessica L; Ralston, Robin A; Riedl, Ken M; Haufe, Thomas C; Schweiggert, Ralf M; King, Samantha A; Timmers, Cynthia D; Francis, David M; Lesinski, Gregory B; Clinton, Steven K; Schwartz, Steven J

    2015-04-01

    Tangerine tomatoes (Solanum lycopersicum) are rich in tetra-cis-lycopene resulting from natural variation in carotenoid isomerase. Our objective was to compare the bioavailability of lycopene from tangerine to red tomato juice, and elucidate physical deposition forms of these isomers in tomatoes by light and electron microscopy. Following a randomized cross-over design, subjects (n = 11, 6 M/5 F) consumed two meals delivering 10 mg lycopene from tangerine (94% cis) or red tomato juice (10% cis). Blood was sampled over 12 h and triglyceride-rich lipoprotein fractions of plasma were isolated and analyzed using HPLC-DAD-MS/MS. Lycopene was crystalline in red tomato chromoplasts and globular in tangerine tomatoes. With tangerine tomato juice we observed a marked 8.5-fold increase in lycopene bioavailability compared to red tomato juice (p rich foods. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  13. 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

    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......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...... 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...

  14. Blind Cat

    Directory of Open Access Journals (Sweden)

    Arka Chattopadhyay

    2015-08-01

    There’s no way to know whether he was blind from birth or blindness was something he had picked up from his fights with other cats. He wasn’t an urban cat. He lived in a little village, soaked in the smell of fish with a river running right beside it. Cats like these have stories of a different kind. The two-storied hotel where he lived had a wooden floor. It stood right on the riverbank and had more than a tilt towards the river, as if deliberately leaning on the water.

  15. 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

  16. 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.

  17. An innovative acupuncture treatment for primary dysmenorrhea: a randomized cross-over pilot study

    Science.gov (United States)

    Wade, Christine M.; Abercrombie, Priscilla D.; Gomolak, Denise

    2013-01-01

    Background/Objective Dysmenorrhea is highly prevalent among adolescent women and a major cause of activity restriction. Standard pharmaceuticals used to treat dysmenorrhea are not effective for all women and have side effects that limit their use. Our study objective was to examine feasibility, acceptability, and preliminary effects of acupuncture point injection of vitamin K1 as an alternative treatment for primary dysmenorrhea among US women. Methods/Design We conducted a pilot study using a crossover trial design. Women with primary dysmenorrhea were randomized to receive vitamin K1 injection in the Spleen-6 acupuncture point at the start of menstruation followed by saline in a non-acupuncture point after two months, or the reverse order of treatments. Setting/Participants The study was conducted in the San Francisco Bay Area among women 18 and 25 years of age diagnosed with primary dysmenorrhea; fourteen women completed all study visits. Primary Outcome Measure Dysmenorrhea pain intensity was measured using a 0–10 numeric rating scale before and after injections. Results Women had an average 2.5 point decrease in pain after vitamin K1 injection in Spleen-6 (p dysmenorrhea among young women in San Francisco. Pain decreased with both treatments, with a trend toward greater pain reduction for vitamin K1/Spleen-6 injection. This is consistent with outcomes from the Obstetrics & Gynecology Hospital in Shanghai, China, where the protocol was developed. PMID:24445356

  18. Blind Ambition

    Science.gov (United States)

    Olson, Catherine Applefeld

    2009-01-01

    No matter how dedicated they may be, some teachers are daunted by extreme challenges. Carol Agler, music director at the Ohio State School for the Blind (OSSB), is not one of those teachers. Since joining the OSSB staff 11 years ago, Agler has revived the school's long-dormant band program and created its first marching band. Next January, she…

  19. Subcutaneous versus intravenous immunoglobulin in multifocal motor neuropathy: a randomized, single-blinded cross-over trial

    DEFF Research Database (Denmark)

    Harbo, Thomas; Andersen, Henning; Hess, Alexander

    2009-01-01

    at the injection sites for a few weeks. All other adverse effects during SCIG were mild and transient. No differences between treatments of health-related quality of life occurred. Conclusion: In MMN, short-term subcutaneous infusion of immunoglobulin is feasible, safe and as effective as intravenous infusion...

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

    NARCIS (Netherlands)

    de Bruijn, J; Duivenvoorden, H.J.; Passchier, J.; Locher, H.; Dijkstra, N.; Arts, W.F.

    2010-01-01

    Background: 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 attacks in young

  1. 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

  2. Effects of Pycnogenol on endothelial function in patients with stable coronary artery disease: a double-blind, randomized, placebo-controlled, cross-over study

    OpenAIRE

    Enseleit, Frank; Sudano, Isabella; Périat, Daniel; Winnik, Stephan; Wolfrum, Mathias; Flammer, Andreas J; Fröhlich, Georg M; Kaiser, Priska; Hirt, Astrid; Haile, Sarah R; Krasniqi, Nazmi; Matter, Christian M; Uhlenhut, Klaus; Högger, Petra; Neidhart, Michel

    2012-01-01

    Aims Extracts from pine tree bark containing a variety of flavonoids have been used in traditional medicine. Pycnogenol is a proprietary bark extract of the French maritime pine tree (Pinus pinaster ssp. atlantica) that exerts antioxidative, anti-inflammatory, and anti-platelet effects. However, the effects of Pycnogenol on endothelial dysfunction, a precursor of atherosclerosis and cardiovascular events, remain still elusive. Methods and results Twenty-three patients with coronary artery dis...

  3. The clinical effect of a new infant formula in term infants with constipation: a double-blind, randomized cross-over trial

    NARCIS (Netherlands)

    Bongers, Marloes E. J.; de Lorijn, Fleur; Reitsma, Johannes B.; Groeneweg, Michael; Taminiau, Jan A. J. M.; Benninga, Marc A.

    2007-01-01

    BACKGROUND: Nutrilon Omneo (new formula; NF) contains high concentration of sn-2 palmitic acid, a mixture of prebiotic oligosaccharides and partially hydrolyzed whey protein. It is hypothesized that NF positively affects stool characteristics in constipated infants. METHODS: Thirty-eight constipated

  4. 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.

  5. A randomized, prospective cross-over trial comparing methylene blue-directed biopsy and conventional random biopsy for detecting intestinal metaplasia and dysplasia in Barrett's esophagus.

    Science.gov (United States)

    Ragunath, K; Krasner, N; Raman, V S; Haqqani, M T; Cheung, W Y

    2003-12-01

    The value of methylene blue-directed biopsies (MBDB) in detecting specialized intestinal metaplasia and dysplasia in Barrett's esophagus remains unclear. The aim of this study was to compare the accuracy of MBDB with random biopsy in detecting intestinal metaplasia and dysplasia in patients with Barrett's esophagus. A prospective, randomized, cross-over trial was undertaken to compare MBDB with random biopsy in patients with Barrett's esophagus segments 3 cm or more in length without macroscopic evidence of dysplasia or cancer. Dysplasia was graded as: indefinite for dysplasia, low-grade dysplasia, high-grade dysplasia, or carcinoma, and was reported in a blinded fashion. Fifty-seven patients were recruited, 44 of whom were male. A total of 1,269 biopsies were taken (MBDB-651, random biopsie-618). Analysis of the results by per-biopsy protocol showed that the MBDB technique diagnosed significantly more specialized intestinal metaplasia (75 %) compared to the random biopsy technique (68 %; P = 0.032). The sensitivity and specificity rates of MBDB for diagnosing specialized intestinal metaplasia were 91 % (95 % CI, 88 - 93 %) and 43 % (95 % CI, 36 - 51 %), respectively. The sensitivity and specificity rates of MBDB for diagnosing dysplasia or carcinoma were 49 % (95 % CI, 38 - 61 %) and 85 % (95 % CI, 82 - 88 %), respectively. There were no significant differences in the diagnosis of dysplasia and carcinoma - MBDB 12 %, random biopsy 10 %. The methylene blue staining pattern appeared to have an influence on the detection of specialized intestinal metaplasia and dysplasia/carcinoma. Dark blue staining was associated with increased detection of specialized intestinal metaplasia (P biopsies. Although MBDB prolongs the endoscopy procedure slightly, it is a safe and well-tolerated procedure. Further clinical studies on the MBDB technique exclusively in endoscopically normal dysplastic Barrett's esophagus are needed.

  6. 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.

  7. 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

  8. Inherited differences in crossing over and gene conversion frequencies between wild strains of Sordaria fimicola from "Evolution Canyon".

    Science.gov (United States)

    Saleem, M; Lamb, B C; Nevo, E

    2001-12-01

    Recombination generates new combinations of existing genetic variation and therefore may be important in adaptation and evolution. We investigated whether there was natural genetic variation for recombination frequencies and whether any such variation was environment related and possibly adaptive. Crossing over and gene conversion frequencies often differed significantly in a consistent direction between wild strains of the fungus Sordaria fimicola isolated from a harsher or a milder microscale environment in "Evolution Canyon," Israel. First- and second-generation descendants from selfing the original strains from the harsher, more variable, south-facing slope had higher frequencies of crossing over in locus-centromere intervals and of gene conversion than those from the lusher north-facing slopes. There were some significant differences between strains within slopes, but these were less marked than between slopes. Such inherited variation could provide a basis for natural selection for optimum recombination frequencies in each environment. There were no significant differences in meiotic hybrid DNA correction frequencies between strains from the different slopes. The conversion analysis was made using only conversions to wild type, because estimations of conversion to mutant were affected by a high frequency of spontaneous mutation. There was no polarized segregation of chromosomes at meiosis I or of chromatids at meiosis II.

  9. 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.)

  10. Acute Blindness.

    Science.gov (United States)

    Meekins, Jessica M

    2015-09-01

    Sudden loss of vision is an ophthalmic emergency with numerous possible causes. Abnormalities may occur at any point within the complex vision pathway, from retina to optic nerve to the visual center in the occipital lobe. This article reviews specific prechiasm (retina and optic nerve) and cerebral cortical diseases that lead to acute blindness. Information regarding specific etiologies, pathophysiology, diagnosis, treatment, and prognosis for vision is discussed. Copyright © 2015 Elsevier Inc. All rights reserved.

  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

    : 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...

  12. Anxiety and methylphenidate in attention deficit hyperactivity disorder: a double-blind placebo-drug trial.

    Science.gov (United States)

    Moshe, Keren; Karni, Avi; Tirosh, Emanuel

    2012-09-01

    To examine the relationship between attention and anxiety and the response to methylphenidate in children with attention deficit hyperactivity disorder (ADHD), a total of 57 boys, between the ages of 7-12 years, were assessed for their attention and level of anxiety. Methylphenidate was administered for a week in a randomized double-blind drug/placebo-drug cross-over design. The levels of anxiety were evenly distributed between the inattentive and hyperactive/impulsive types. Anxiety was significantly correlated with the attention as reported by both teachers and parents. The response to methylphenidate was inversely correlated with the reported anxiety level only in boys with the hyperactive/impulsive and combined types. The higher the level of anxiety, the lower level of response to methylphenidate was observed. In the assessment and treatment of children with ADHD, the level of anxiety should be evaluated and taken into account while planning and monitoring treatment regiment.

  13. Treatment of fatigue with methylphenidate, modafinil and amantadine in multiple sclerosis (TRIUMPHANT-MS): Study design for a pragmatic, randomized, double-blind, crossover clinical trial.

    Science.gov (United States)

    Nourbakhsh, Bardia; Revirajan, Nisha; Waubant, Emmanuelle

    2018-01-01

    Fatigue is the most common symptom of multiple sclerosis (MS). Amantadine, modafinil and amphetamine-like stimulants are commonly used in clinical practice for treatment of fatigue; however, the evidence supporting their effectiveness is sparse and conflicting. To describe the design of a trial study funded by Patient-Centered Outcome Research Institute (PCORI) that will compare the efficacy of commonly used fatigue medications in patients with MS. The study is a randomized, placebo-controlled, crossover, four-sequence, four-period, double-blind, multicenter trial of three commonly used medications for the treatment of MS-related fatigue (amantadine, modafinil, methylphenidate) versus placebo in fatigued subjects with MS. Adult patients with MS, with an Expanded Disability Status Scale of MS-related fatigue. Clinicaltrials.gov registration number: NCT03185065. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Cross-over between discrete and continuous protein structure space: insights into automatic classification and networks of protein structures.

    Directory of Open Access Journals (Sweden)

    Alberto Pascual-García

    2009-03-01

    Full Text Available Structural classifications of proteins assume the existence of the fold, which is an intrinsic equivalence class of protein domains. Here, we test in which conditions such an equivalence class is compatible with objective similarity measures. We base our analysis on the transitive property of the equivalence relationship, requiring that similarity of A with B and B with C implies that A and C are also similar. Divergent gene evolution leads us to expect that the transitive property should approximately hold. However, if protein domains are a combination of recurrent short polypeptide fragments, as proposed by several authors, then similarity of partial fragments may violate the transitive property, favouring the continuous view of the protein structure space. We propose a measure to quantify the violations of the transitive property when a clustering algorithm joins elements into clusters, and we find out that such violations present a well defined and detectable cross-over point, from an approximately transitive regime at high structure similarity to a regime with large transitivity violations and large differences in length at low similarity. We argue that protein structure space is discrete and hierarchic classification is justified up to this cross-over point, whereas at lower similarities the structure space is continuous and it should be represented as a network. We have tested the qualitative behaviour of this measure, varying all the choices involved in the automatic classification procedure, i.e., domain decomposition, alignment algorithm, similarity score, and clustering algorithm, and we have found out that this behaviour is quite robust. The final classification depends on the chosen algorithms. We used the values of the clustering coefficient and the transitivity violations to select the optimal choices among those that we tested. Interestingly, this criterion also favours the agreement between automatic and expert classifications

  15. The occurrence of double strand DNA breaks is not the sole condition for meiotic crossing over in Drosophila melanogaster.

    Science.gov (United States)

    Portin, P; Rantanen, M

    2000-01-01

    Analysis of the interchromosomal effects of In(2L + 2R)Cy, In(3L + 3R)LVM and their joint effect on the frequencies of single and double crossovers in the cv-v-f region of the X chromosome as well as interference showed that both inversions, occurring separately, increased the frequency of single as well as double crossovers and the coefficient of coincidence. However, when the inversions occurred together the frequencies of single crossovers no longer increased, but the frequency of double crossovers, as well as the coefficient of coincidence did increase. These results indicate firstly that the interchromosomal effects influence some precondition of exchange, but that this precondition is not an occurrence of double strand DNA breaks. Thus, the occurrence of double strand DNA breaks is not the sole condition for crossing over in Drosophila melanogaster.

  16. Aspartame Sensitivity? A Double Blind Randomised Crossover Study

    OpenAIRE

    Sathyapalan, Thozhukat; Thatcher, Natalie J.; Hammersley, Richard; Rigby, Alan S.; Pechlivanis, Alexandros; Gooderham, Nigel J.; Holmes, Elaine; le Roux, Carel W.; Atkin, Stephen L.; Courts, Fraser

    2015-01-01

    Background Aspartame is a commonly used intense artificial sweetener, being approximately 200 times sweeter than sucrose. There have been concerns over aspartame since approval in the 1980s including a large anecdotal database reporting severe symptoms. The objective of this study was to compare the acute symptom effects of aspartame to a control preparation. Methods This was a double-blind randomized cross over study conducted in a clinical research unit in United Kingdom. Forty-eight indivi...

  17. 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)

  18. 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

  19. B-type natriuretic peptide (BNP) affects the initial response to intravenous glucose: a randomised placebo-controlled cross-over study in healthy men.

    Science.gov (United States)

    Heinisch, B B; Vila, G; Resl, M; Riedl, M; Dieplinger, B; Mueller, T; Luger, A; Pacini, G; Clodi, M

    2012-05-01

    B-type natriuretic peptide (BNP) is a hormone released from cardiomyocytes in response to cell stretching and elevated in heart failure. Recent observations indicate a distinct connection between chronic heart failure and diabetes mellitus. This study investigated the role of BNP on glucose metabolism. Ten healthy volunteers (25 ± 1 years; BMI 23 ± 1 kg/m(2); fasting glucose 4.6 ± 0.1 mmol/l) were recruited to a participant-blinded investigator-open placebo-controlled cross-over study, performed at a university medical centre. They were randomly assigned (sequentially numbered opaque sealed envelopes) to receive either placebo or 3 pmol kg(-1) min(-1) BNP-32 intravenously during 4 h on study day 1 or 2. One hour after beginning the BNP/placebo infusion, a 3 h intravenous glucose tolerance test (0.33 g/kg glucose + 0.03 U/kg insulin at 20 min) was performed. Plasma glucose, insulin and C-peptide were frequently measured. Ten volunteers per group were analysed. BNP increased the initial glucose distribution volume (13 ± 1% body weight vs 11 ± 1%, p < 0.002), leading to an overall reduction in glucose concentration (p < 0.001), particularly during the initial 20 min of the test (p = 0.001), accompanied by a reduction in the initial C-peptide levels (1.42 ± 0.13 vs 1.62 ± 0.10 nmol/l, p = 0.015). BNP had no impact on beta cell function, insulin clearance or insulin sensitivity and induced no adverse effects. Intravenous administration of BNP increases glucose initial distribution volume and lowers plasma glucose concentrations following a glucose load, without affecting beta cell function or insulin sensitivity. These data support the theory that BNP has no diabetogenic properties, but improves metabolic status in men, and suggest new questions regarding BNP-induced differences in glucose availability and signalling in various organs/tissues. ClinicalTrials.gov: NCT01324739 The study was funded by Jubilée Fonds of the Austrian National Bank (OeNB-Fonds).

  20. 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.

  1. 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.

  2. An approach to combining parallel and cross-over trials with and without run-in periods using individual patient data.

    Science.gov (United States)

    Tvete, Ingunn F; Olsen, Inge C; Fagerland, Morten W; Meland, Nils; Aldrin, Magne; Smerud, Knut T; Holden, Lars

    2012-04-01

    In active run-in trials, where patients may be excluded after a run-in period based on their response to the treatment, it is implicitly assumed that patients have individual treatment effects. If individual patient data are available, active run-in trials can be modelled using patient-specific random effects. With more than one trial on the same medication available, one can obtain a more precise overall treatment effect estimate. We present a model for joint analysis of a two-sequence, four-period cross-over trial (AABB/BBAA) and a three-sequence, two-period active run-in trial (AB/AA/A), where the aim is to investigate the effect of a new treatment for patients with pain due to osteoarthritis. Our approach enables us to separately estimate the direct treatment effect for all patients, for the patients excluded after the active run-in trial prior to randomisation, and for the patients who completed the active run-in trial. A similar model approach can be used to analyse other types of run-in trials, but this depends on the data and type of other trials available. We assume equality of the various carry-over effects over time. The proposed approach is flexible and can be modified to handle other designs. Our results should be encouraging for those responsible for planning cost-efficient clinical development programmes.

  3. Further evidence that aberrant segregation and crossing over in Sordaria brevicollis may be discrete, though associated, events.

    Science.gov (United States)

    Theivendirarajah, K; Whitehouse, H L

    1983-01-01

    Crosses were made between buff spore colour mutants in Sordaria brevicollis in the presence of flanking markers. Recombinant asci with one or more wild-type spores were isolated and the spores germinated and scored for buff and flanking marker genotype. The buff genotype was determined by back-crossing to each parent and looking for recombinants. It was found that the majority of the recombinant asci had aberrant segregation at one or other mutant site but not both. It was inferred that in the recombinants hybrid DNA rarely extended to both sites. When the aberrant segregation was associated with crossing-over, the crossovers were situated at either end of the gene rather than between the allelic sites where the hybrid DNA was believed to terminate. Thus, some of the crossovers were separated from the site of the aberrant segregation by a site apparently not involved in hybrid DNA and none was in the position predicted by the Meselson-Radding model, that is, where the hybrid DNA terminates.

  4. Vegetable versus animal protein diet in cirrhotic patients with chronic encephalopathy. A randomized cross-over comparison.

    Science.gov (United States)

    Bianchi, G P; Marchesini, G; Fabbri, A; Rondelli, A; Bugianesi, E; Zoli, M; Pisi, E

    1993-05-01

    In a randomized cross-over comparison, the effects of a mainly vegetable protein diet were compared with an animal protein diet in eight patients with cirrhosis and chronic permanent encephalopathy, under optimum lactulose therapy. After a run-in period, patients were fed two equi-caloric, equi-nitrogenous diets for 7 days (71 g total proteins), containing either 50 g protein of animal origin or 50 g vegetable proteins. In the last 3 days of each period, nitrogen balance was significantly better during the vegetable protein diet (+0.2 (SD 1.4) g vs. -1.7 (2.4); P vegetable proteins, whereas insulin, plasma amino acids and ammonia were lower. The clinical grading of encephalopathy improved slightly on vegetable proteins, and psychometric tests improved significantly, but remained grossly abnormal. Compliance to dietary manipulation was good. The data prove that a mainly vegetable protein diet is worthwhile in cirrhotic patients with chronic encephalopathy under optimum lactulose therapy. Improved nitrogen balance may be related to more effective nitrogen use for protein synthesis, probably due to blunted hormonal response, and largely outweighs the effects on encephalopathy.

  5. 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

    2018-04-01

    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 stress levels (n = 25) felt more alert after interventions including balneotherapy, whereas they reported an increase of tiredness when walking was combined with resting (F = 3.20; p = .044). Results suggest that combining physical activity and 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.

  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. Randomized placebo controlled blinded study to assess valsartan efficacy in preventing left ventricle remodeling in patients with dual chamber pacemaker--Rationale and design of the trial.

    Science.gov (United States)

    Tomasik, Andrzej; Jacheć, Wojciech; Wojciechowska, Celina; Kawecki, Damian; Białkowska, Beata; Romuk, Ewa; Gabrysiak, Artur; Birkner, Ewa; Kalarus, Zbigniew; Nowalany-Kozielska, Ewa

    2015-05-01

    Dual chamber pacing is known to have detrimental effect on cardiac performance and heart failure occurring eventually is associated with increased mortality. Experimental studies of pacing in dogs have shown contractile dyssynchrony leading to diffuse alterations in extracellular matrix. In parallel, studies on experimental ischemia/reperfusion injury have shown efficacy of valsartan to inhibit activity of matrix metalloproteinase-9, to increase the activity of tissue inhibitor of matrix metalloproteinase-3 and preserve global contractility and left ventricle ejection fraction. To present rationale and design of randomized blinded trial aimed to assess whether 12 month long administration of valsartan will prevent left ventricle remodeling in patients with preserved left ventricle ejection fraction (LVEF ≥ 40%) and first implantation of dual chamber pacemaker. A total of 100 eligible patients will be randomized into three parallel arms: placebo, valsartan 80 mg/daily and valsartan 160 mg/daily added to previously used drugs. The primary endpoint will be assessment of valsartan efficacy to prevent left ventricle remodeling during 12 month follow-up. We assess patients' functional capacity, blood plasma activity of matrix metalloproteinases and their tissue inhibitors, NT-proBNP, tumor necrosis factor alpha, and Troponin T. Left ventricle function and remodeling is assessed echocardiographically: M-mode, B-mode, tissue Doppler imaging. If valsartan proves effective, it will be an attractive measure to improve long term prognosis in aging population and increasing number of pacemaker recipients. ClinicalTrials.org (NCT01805804). Copyright © 2015 Elsevier Inc. All rights reserved.

  8. A Randomised, Double-Blind, Placebo-Controlled Trial of Actovegin in Patients with Post-Stroke Cognitive Impairment: ARTEMIDA Study Design

    Directory of Open Access Journals (Sweden)

    Alla Guekht

    2013-12-01

    Full Text Available Background: No drug treatment to date has shown convincing clinical evidence of restoring cognitive function or preventing further decline after stroke. The ongoing ARTEMIDA study will evaluate the efficacy and safety of Actovegin for the symptomatic treatment of post-stroke cognitive impairment (PSCI and will explore whether Actovegin has any disease-modifying effect by assessing whether any changes are sustained after treatment. Design: ARTEMIDA is a 12-month, multicentre trial in patients (planned a total of 500, now recruited with cognitive impairment following ischaemic stroke. The study consists of a baseline screening (≤7 days after stroke, after which eligible patients are randomised to Actovegin (2,000 mg/day for up to 20 intravenous infusions followed by 1,200 mg/day orally or placebo for a 6-month double-blind treatment period. Patients will be followed up for a further 6 months, during which time they will be treated in accordance with standard clinical practice. The primary study endpoint is change from baseline in the Alzheimer's Disease Assessment Scale, cognitive subscale, extended version. Secondary outcomes include: Montreal Cognitive Assessment; dementia diagnosis (ICD-10; National Institutes of Health Stroke Scale; Barthel Index; EQ-5D; Beck Depression Inventory, version II, and safety. Conclusion: There is a clear need for effective treatments for PSCI. ARTEMIDA should provide important insights into the use of a novel drug therapy for PSCI.

  9. 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.

  10. MTN-001: randomized pharmacokinetic cross-over study comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other compartments.

    Directory of Open Access Journals (Sweden)

    Craig W Hendrix

    Full Text Available 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.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.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 (p<0.001. Vaginal tissue tenofovir diphosphate was quantifiable in ≥90% of women 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 (p<0.001. Rectal fluid tenofovir concentrations in vaginal dosing periods were higher than concentrations measured in the oral only dosing period (p<0.03.Compared to oral 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

  11. 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.

  12. 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.

  13. Effects of almond and pistachio consumption on gut microbiota composition in a randomised cross-over human feeding study.

    Science.gov (United States)

    Ukhanova, Maria; Wang, Xiaoyu; Baer, David J; Novotny, Janet A; Fredborg, Marlene; Mai, Volker

    2014-06-28

    The modification of microbiota composition to a 'beneficial' one is a promising approach for improving intestinal as well as overall health. Natural fibres and phytochemicals that reach the proximal colon, such as those present in various nuts, provide substrates for the maintenance of healthy and diverse microbiota. The effects of increased consumption of specific nuts, which are rich in fibre as well as various phytonutrients, on human gut microbiota composition have not been investigated to date. The objective of the present study was to determine the effects of almond and pistachio consumption on human gut microbiota composition. We characterised microbiota in faecal samples collected from volunteers in two separate randomised, controlled, cross-over feeding studies (n 18 for the almond feeding study and n 16 for the pistachio feeding study) with 0, 1·5 or 3 servings/d of the respective nuts for 18 d. Gut microbiota composition was analysed using a 16S rRNA-based approach for bacteria and an internal transcribed spacer region sequencing approach for fungi. The 16S rRNA sequence analysis of 528 028 sequence reads, retained after removing low-quality and short-length reads, revealed various operational taxonomic units that appeared to be affected by nut consumption. The effect of pistachio consumption on gut microbiota composition was much stronger than that of almond consumption and included an increase in the number of potentially beneficial butyrate-producing bacteria. Although the numbers of bifidobacteria were not affected by the consumption of either nut, pistachio consumption appeared to decrease the number of lactic acid bacteria (Ppistachios appears to be an effective means of modifying gut microbiota composition.

  14. Acute electromyographic responses of deep thoracic paraspinal muscles to spinal manual therapy interventions. An experimental, randomized cross-over study.

    Science.gov (United States)

    Fryer, Gary; Bird, Michael; Robbins, Barry; Johnson, Jane C

    2017-07-01

    This single group, randomized, cross-over study explored whether manual therapy alters motor tone of deep thoracic back muscles by examining resting electromyographic activity (EMG) after 2 types of manual therapy and a sham control intervention. Twenty-two participants with thoracic spinal pain (15 females, 7 males, mean age 28.1 ± 6.4 years) had dual fine-wire, intramuscular electrodes inserted into deep transversospinalis muscles at a thoracic level where tissues appeared abnormal to palpation (AbP) and at 2 sites above and below normal and non-tender to palpation (NT). A surface electrode was on the contralateral paraspinal mass at the level of AbP. EMG signals were recorded for resting prone, two 3-s free neck extension efforts, two 3-s resisted maximal voluntary isometric contractions (MVIC), and resting prone before the intervention. Randomized spinal manipulation, counterstrain, or sham manipulation was delivered and EMG re-measured. Participants returned 1 and 2 weeks later for the remaining 2 treatments. Reductions in resting EMG followed counterstrain in AbP (median decrease 3.3%, P = 0.01) and NT sites (median decrease 1.0%, P = 0.05) and for the surface electrode site (median decrease 2.0%, P = 0.009). Reduction in EMG following counterstrain during free neck extension was found for the surface electrode site (median decrease 2.7%, P < 0.01). Spinal manipulation produced no change in EMG, whereas counterstrain technique produced small significant reductions in paraspinal muscle activity during prone resting and free neck extension conditions. The clinical relevance of these changes is unclear. Copyright © 2017 Elsevier Ltd. All rights reserved.

  15. 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.

  16. 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.

  17. Poor chest compression quality with mechanical compressions in simulated cardiopulmonary resuscitation: a randomized, cross-over manikin study.

    Science.gov (United States)

    Blomberg, Hans; Gedeborg, Rolf; Berglund, Lars; Karlsten, Rolf; Johansson, Jakob

    2011-10-01

    Mechanical chest compression devices are being implemented as an aid in cardiopulmonary resuscitation (CPR), despite lack of evidence of improved outcome. This manikin study evaluates the CPR-performance of ambulance crews, who had a mechanical chest compression device implemented in their routine clinical practice 8 months previously. The objectives were to evaluate time to first defibrillation, no-flow time, and estimate the quality of compressions. The performance of 21 ambulance crews (ambulance nurse and emergency medical technician) with the authorization to perform advanced life support was studied in an experimental, randomized cross-over study in a manikin setup. Each crew performed two identical CPR scenarios, with and without the aid of the mechanical compression device LUCAS. A computerized manikin was used for data sampling. There were no substantial differences in time to first defibrillation or no-flow time until first defibrillation. However, the fraction of adequate compressions in relation to total compressions was remarkably low in LUCAS-CPR (58%) compared to manual CPR (88%) (95% confidence interval for the difference: 13-50%). Only 12 out of the 21 ambulance crews (57%) applied the mandatory stabilization strap on the LUCAS device. The use of a mechanical compression aid was not associated with substantial differences in time to first defibrillation or no-flow time in the early phase of CPR. However, constant but poor chest compressions due to failure in recognizing and correcting a malposition of the device may counteract a potential benefit of mechanical chest compressions. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  18. Acute effect on ambulatory blood pressure from aerobic exercise: a randomised cross-over study among female cleaners.

    Science.gov (United States)

    Lund Rasmussen, Charlotte; Nielsen, Line; Linander Henriksen, Marie; Søgaard, Karen; Krustrup, Peter; Holtermann, Andreas; Korshøj, Mette

    2018-02-01

    High occupational physical activity (OPA) is shown to increase the risk for elevated blood pressure, cardiovascular diseases and mortality. Conversely, aerobic exercise acutely lowers the blood pressure up to 25 h post exercise. However, it is unknown if this beneficial effect also apply for workers exposed to high levels of OPA. Cleaners constitute a relevant occupational group for this investigation because of a high prevalence of OPA and cardiovascular disease. Accordingly, the objective was to investigate the acute effects on ambulatory blood pressure from a single aerobic exercise session among female cleaners. Twenty-two female cleaners were randomised to a cross-over study with a reference and an aerobic exercise session. Differences in 24-h, work hours, leisure time, and sleep ambulatory blood pressure (ABP) were evaluated using repeated measure 2 × 2 mixed-models. After the aerobic exercise session, the 24-h systolic ambulatory blood pressure was significantly lowered by 2.4 mmHg (p ABP was unaltered. During work hours, a lowered systolic ABP of 2.2 mmHg (p = 0.02) and a higher diastolic ABP of 1.5 mmHg (p = 0.03) were found after the aerobic exercise session. During leisure time, the systolic ABP was lowered by 1.7 mmHg (p = 0.04) and the diastolic ABP was unaltered. During sleep, the systolic and diastolic ABP was unaltered. A single aerobic exercise session lowered 24-h systolic ABP of 2.4 mmHg. Thus, an aerobic exercise session seems to be beneficial for lowering the risk of hypertension among cleaners.

  19. 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% (preduced after OCD (p<0.05) compared to NOC. 24 h OCD alters both, the sympathetic-adrenomedullary system as well as the hypothalamic pituitary-adrenocortical axis. Moreover, physicians' emotional state, cognitive and oculomotor performance seems to be influenced independently from sleep 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.

  20. 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.

  1. 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

  2. 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.

  3. A single-dose, randomized, cross-over, two-way, open-label study for comparing the absorption of boswellic acids and its lecithin formulation.

    Science.gov (United States)

    Riva, Antonella; Morazzoni, Paolo; Artaria, Christian; Allegrini, Pietro; Meins, Jürgen; Savio, Daniele; Appendino, Giovanni; Schubert-Zsilavecz, Manfred; Abdel-Tawab, Mona

    2016-11-15

    The oral administration of the gum resin extracts of Indian frankincense (Boswellia serrata Roxb. ex Colebr) results in very low plasma concentrations of boswellic acids (BAs), being far below the pharmacologically active concentrations required in vitro for anti-inflammatory activity. For that reason the use of Indian frankincense in clinical practice and pharmaceutical development has substantially lagged behind. Recently the application of new formulation technologies resulted in a formulation of frankincense extract with lecithin, which revealed improved absorption and tissue penetration of BAs in a rodent study, leading for the first time to plasma concentrations of BAs in the range of their anti-inflammatory activity. In order to verify these encouraging results in humans, the absorption of a standardized Boswellia serrata extract (BE) and its lecithin formulation (CSP) was comparatively investigated in healthy volunteers. According to a randomized cross-over design with two treatments, two sequences and two periods, 12 volunteers alternatively received the lecithin-formulated Boswellia extract (CSP) or the non-formulated Boswellia extract (BE) at a dosage of 2×250mg capsules. The plasma concentrations of the six major BAs (KBA, AKBA, βBA, αBA, AβBA, AαBA) were determined using LC/MS. With the exception of KBA, a significantly higher (both in terms of weight-to-weight and molar comparison) and quicker absorption of BAs from the lecithin formulation was observed, leading to C max in the range required for the interaction with their molecular targets. These findings pave the way to further studies evaluating the clinical potential of BAs, and verify the beneficial effect of lecithin formulation to improve the absorption of poorly soluble phytochemicals. Copyright © 2016 The Authors. Published by Elsevier GmbH.. All rights reserved.

  4. No evidence of dehydration with moderate daily coffee intake: a counterbalanced cross-over study in a free-living population.

    Directory of Open Access Journals (Sweden)

    Sophie C Killer

    Full Text Available It is often suggested that coffee causes dehydration and its consumption should be avoided or significantly reduced to maintain fluid balance. The aim of this study was to directly compare the effects of coffee consumption against water ingestion across a range of validated hydration assessment techniques. In a counterbalanced cross-over design, 50 male coffee drinkers (habitually consuming 3-6 cups per day participated in two trials, each lasting three consecutive days. In addition to controlled physical activity, food and fluid intake, participants consumed either 4×200 mL of coffee containing 4 mg/kg caffeine (C or water (W. Total body water (TBW was calculated pre- and post-trial via ingestion of Deuterium Oxide. Urinary and haematological hydration markers were recorded daily in addition to nude body mass measurement (BM. Plasma was analysed for caffeine to confirm compliance. There were no significant changes in TBW from beginning to end of either trial and no differences between trials (51.5±1.4 vs. 51.4±1.3 kg, for C and W, respectively. No differences were observed between trials across any haematological markers or in 24 h urine volume (2409±660 vs. 2428±669 mL, for C and W, respectively, USG, osmolality or creatinine. Mean urinary Na(+ excretion was higher in C than W (p = 0.02. No significant differences in BM were found between conditions, although a small progressive daily fall was observed within both trials (0.4±0.5 kg; p<0.05. Our data show that there were no significant differences across a wide range of haematological and urinary markers of hydration status between trials. These data suggest that coffee, when consumed in moderation by caffeine habituated males provides similar hydrating qualities to water.

  5. Short-Term Effects of Lupin vs. Whey Supplementation on Glucose and Insulin Responses to a Standardized Meal in a Randomized Cross-Over Trial.

    Science.gov (United States)

    Schopen, Kathrin; Ewald, Ann C; Johannes, Bernd W; Bloch, Wilhelm; Rittweger, Jörn; Frings-Meuthen, Petra

    2017-01-01

    Background: Whey protein is known to reduce postprandial glycaemia in people with type 2 diabetes mellitus. Lupin as a vegetable source of protein could be considered as an alternative, as the percentage of vegetarian and vegan consumers is raising. The present study compares the acute glycemic effects of whey and lupin in healthy volunteers following a carbohydrate-rich reference meal. Methods In cross-over design, three standardized meals (reference meal; reference meal + whey; reference meal + lupin) were provided to 12 healthy male and female volunteers, aged between 23 and 33, in a balanced, randomized order. Volunteers' blood glucose and insulin concentrations were analyzed at baseline and at seven time points following the ingestion of the meals. Results: The supplementation of whey or lupin significantly blunted the postprandial increase in blood glucose concentrations compared to the reference meal ( p AUC whey-lupin = 8%, 0-60 min area under the curve (0-60 min AUC), p = 0.937], with a blunting effect of -46% by whey ( p = 0.005, 0-60 min AUC) and of -54% by lupin ( p AUC). When comparing whey and lupin data only, the insulin increase was found to be more pronounced for whey protein than for lupin supplementation (Δ AUC whey-lupin = 39%, 0-60 min AUC, p = 0.022). However, when comparing the insulin response of each supplementation to the one of the reference meal, no differences could be detected (whey p = 0.259, 0-60 min AUC; lupin p = 0.275, 0-60 min AUC). Conclusions: Results suggest that lupin and whey can both lower the increase of postprandial blood glucose concentrations to a comparable extent, implying the usability of lupin to reduce postprandial glycaemia. However, the insulin response following the supplementations to a carbohydrate-rich meal seems to differ for these two protein sources.

  6. 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

  7. 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.

  8. The Infant Fish Oil Supplementation Study (IFOS): design and research protocol of a double-blind, randomised controlled n--3 LCPUFA intervention trial in term infants.

    Science.gov (United States)

    Meldrum, S J; D'Vaz, N; Dunstan, J; Mori, T A; Prescott, S L

    2011-09-01

    The Infant Fish Oil Supplementation Study is a double-blind randomised controlled trial investigating whether the incidence of allergic disease can be reduced and developmental outcomes enhanced through supplementation with omega-3 fatty acids. Infants at high risk of developing allergic disease will be randomised to receive either fish oil or olive oil supplements until 6 months of age and followed up at six postnatal clinic visits to assess allergy outcomes and infant neurodevelopment. Study groups to consist of a treatment group allocated to receive 650 mg of fish oil daily (250-280 mg docosahexaenoic acid and at least 60 mg eicosapentaenoic acid and a placebo group (olive oil) from birth to 6 months of age. Allergy outcomes will be assessed by clinical history, clinical assessments and allergen skin prick tests at the 12, 30 and 60 month visits. Neurodevelopmental assessments to be conducted at 18 months, and language questionnaires at 12, 18 and 30 months. Samples will be collected from mothers antenatally, from infants at birth, and at clinic visits from 6 months onwards for immunological assessments. Fatty acid composition to be measured in erythrocytes and plasma (at birth and after the supplementation period) to assess the effect of the intervention on fatty acid status. Information on medical history, diet and other lifestyle factors at an antenatal clinic visit and postnatal clinic visits will also be collected. This study is designed to examine clinically relevant effects of a novel, non-invasive and potentially low cost approach to reduce the incidence of allergic disease and facilitate neurodevelopment during early childhood. Copyright © 2011 Elsevier Inc. All rights reserved.

  9. Pre-operative use of dexamethasone does not reduce incidence or intensity of bleaching-induced tooth sensitivity. A triple-blind, parallel-design, randomized clinical trial.

    Science.gov (United States)

    da Costa Poubel, Luiz Augusto; de Gouvea, Cresus Vinicius Deppes; Calazans, Fernanda Signorelli; Dip, Etyene Castro; Alves, Wesley Veltri; Marins, Stella Soares; Barcelos, Roberta; Barceleiro, Marcos Oliveira

    2018-04-25

    This study evaluated the effect of the administration of pre-operative dexamethasone on tooth sensitivity stemming from in-office bleaching. A triple-blind, parallel-design, randomized clinical trial was conducted on 70 volunteers who received dexamethasone or placebo capsules. The drugs were administered in a protocol of three daily 8-mg doses of the drug, starting 48 h before the in-office bleaching treatment. Two bleaching sessions with 37.5% hydrogen peroxide gel were performed with a 1-week interval. Tooth sensitivity (TS) was recorded on visual analog scales (VAS) and numeric rating scales (NRS) in different periods up to 48 h after bleaching. The color evaluations were also performed. The absolute risk of TS and its intensity were evaluated by using Fisher's exact test. Comparisons of the TS intensity (NRS and VAS data) were performed by using the Mann-Whitney U test and a two-way repeated measures ANOVA and Tukey's test, respectively. In both groups, a high risk of TS (Dexa 80% x Placebo 94%) was detected. No significant difference was observed in terms of TS intensity. A whitening of approximately 3 shade guide units of the VITA Classical was detected in both groups, which were statistically similar. It was concluded that the administration pre-operatively of dexamethasone, in the proposed protocol, does not reduce the incidence or intensity of bleaching-induced tooth sensitivity. The use of dexamethasone drug before in-office bleaching treatment does not reduce incidence or intensity of tooth sensitivity. NCT02956070.

  10. Mentoring Transition-Age Youth with Blindness

    Science.gov (United States)

    Bell, Edward C.

    2012-01-01

    This article reports on a mentoring project designed for transition-age youth (ages 16-26) who are persons with legal blindness. Youth were matched with adult mentors who were also persons with blindness but who have achieved academic and career success. Results demonstrate that youth who participated in the project for 2 years had significant…

  11. 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

  12. 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

  13. Minimally invasive computer-navigated total hip arthroplasty, following the concept of femur first and combined anteversion: design of a blinded randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Woerner Michael

    2011-08-01

    Full Text Available Abstract Background Impingement can be a serious complication after total hip arthroplasty (THA, and is one of the major causes of postoperative pain, dislocation, aseptic loosening, and implant breakage. Minimally invasive THA and computer-navigated surgery were introduced several years ago. We have developed a novel, computer-assisted operation method for THA following the concept of "femur first"/"combined anteversion", which incorporates various aspects of performing a functional optimization of the cup position, and comprehensively addresses range of motion (ROM as well as cup containment and alignment parameters. Hence, the purpose of this study is to assess whether the artificial joint's ROM can be improved by this computer-assisted operation method. Second, the clinical and radiological outcome will be evaluated. Methods/Design A registered patient- and observer-blinded randomized controlled trial will be conducted. Patients between the ages of 50 and 75 admitted for primary unilateral THA will be included. Patients will be randomly allocated to either receive minimally invasive computer-navigated "femur first" THA or the conventional minimally invasive THA procedure. Self-reported functional status and health-related quality of life (questionnaires will be assessed both preoperatively and postoperatively. Perioperative complications will be registered. Radiographic evaluation will take place up to 6 weeks postoperatively with a computed tomography (CT scan. Component position will be evaluated by an independent external institute on a 3D reconstruction of the femur/pelvis using image-processing software. Postoperative ROM will be calculated by an algorithm which automatically determines bony and prosthetic impingements. Discussion In the past, computer navigation has improved the accuracy of component positioning. So far, there are only few objective data quantifying the risks and benefits of computer navigated THA. Therefore, this

  14. 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

  15. 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

  16. Fair quantum blind signatures

    International Nuclear Information System (INIS)

    Tian-Yin, Wang; Qiao-Yan, Wen

    2010-01-01

    We present a new fair blind signature scheme based on the fundamental properties of quantum mechanics. In addition, we analyse the security of this scheme, and show that it is not possible to forge valid blind signatures. Moreover, comparisons between this scheme and public key blind signature schemes are also discussed. (general)

  17. 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

  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. 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

  20. 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 ).

  1. Spatial Memory by Blind and Sighted Children

    Science.gov (United States)

    Millar, Susanna

    1975-01-01

    Non-verbal recall of haptically presented spatial positions by three age groups of blind and sighted children was tested under conditions varying cuing, recall type and stimulus position in a within-subject design. (Editor)

  2. 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.

  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. 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

  5. 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

  6. Global data on blindness.

    Science.gov (United States)

    Thylefors, B.; Négrel, A. D.; Pararajasegaram, R.; Dadzie, K. Y.

    1995-01-01

    Globally, it is estimated that there are 38 million persons who are blind. Moreover, a further 110 million people have low vision and are at great risk of becoming blind. The main causes of blindness and low vision are cataract, trachoma, glaucoma, onchocerciasis, and xerophthalmia; however, insufficient data on blindness from causes such as diabetic retinopathy and age-related macular degeneration preclude specific estimations of their global prevalence. The age-specific prevalences of the major causes of blindness that are related to age indicate that the trend will be for an increase in such blindness over the decades to come, unless energetic efforts are made to tackle these problems. More data collected through standardized methodologies, using internationally accepted (ICD-10) definitions, are needed. Data on the incidence of blindness due to common causes would be useful for calculating future trends more precisely. PMID:7704921

  7. 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

  8. The Environmental Perceptions of Blind Persons and Their Haptic Representation

    Science.gov (United States)

    Kidwell, Ann Middleton; Greer, Peter Swartz

    1972-01-01

    Reported were the research, design and production of a sophisticated, challenging tactual mobility map (of Massachusetts Institute of Technology Campus) for highly motivated and mobile blind users. (GW)

  9. A randomized cross-over trial to detect differences in arm volume after low- and heavy-load resistance exercise among patients receiving adjuvant chemotherapy for breast cancer at risk for arm lymphedema

    DEFF Research Database (Denmark)

    Bloomquist, Kira; Hayes, Sandi; Adamsen, Lis

    2016-01-01

    changes after resistance exercise with heavy loads in this population. The purpose of this study is to determine acute changes in arm volume after a session of low- and heavy-load resistance exercise among women undergoing adjuvant chemotherapy for breast cancer at risk for arm lymphedema. METHODS....../DESIGN: This is a randomized cross-over trial. PARTICIPANTS: Women receiving adjuvant chemotherapy for breast cancer who have undergone axillary lymph node dissection will be recruited from rehabilitation centers in the Copenhagen area. INTERVENTION: Participants will be randomly assigned to engage in a low- (two sets of 15...... was calculated based on changes in L-Dex scores between baseline and 72-hours post exercise sessions. DISCUSSION: Findings from this study are relevant for exercise prescription guidelines, as well as recommendations regarding participating in activities of daily living for women following surgery for breast...

  10. 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.

  11. Effect of the dietary supplement Meltdown on catecholamine secretion, markers of lipolysis, and metabolic rate in men and women: a randomized, placebo controlled, cross-over study

    Directory of Open Access Journals (Sweden)

    Fisher-Wellman Kelsey H

    2009-08-01

    Full Text Available Abstract Background We have recently reported that the dietary supplement Meltdown® increases plasma norepinephrine (NE, epinephrine (EPI, glycerol, free fatty acids (FFA, and metabolic rate in men. However, in that investigation measurements ceased at 90 minutes post ingestion, with values for blood borne variables peaking at this time. It was the purpose of the present investigation to extend the time course of measurement to 6 hours, and to include women within the design to determine if sex differences to treatment exist. Methods Ten men (24 ± 4 yrs and 10 women (22 ± 2 yrs ingested Meltdown® or a placebo, using a randomized, cross-over design with one week separating conditions. Blood samples were collected immediately before supplementation and at one hour intervals through 6 hours post ingestion. A standard meal was provided after the hour 3 collection. Samples were assayed for EPI, NE, glycerol, and FFA. Five minute breath samples were collected at each time for measurement of metabolic rate and substrate utilization. Area under the curve (AUC was calculated. Heart rate and blood pressure were recorded at all times. Data were also analyzed using a 2 (sex × 2 (condition × 7 (time repeated measures analysis of variance, with Tukey post hoc testing. Results No sex × condition interactions were noted for AUC for any variable (p > 0.05. Hence, AUC data are collapsed across men and women. AUC was greater for Meltdown® compared to placebo for EPI (367 ± 58 pg·mL-1·6 hr-1 vs. 183 ± 27 pg·mL-1·6 hr-1; p = 0.01, NE (2345 ± 205 pg·mL-1·6 hr-1 vs. 1659 ± 184 pg·mL-1·6 hr-1; p = 0.02, glycerol (79 ± 8 μg·mL-1·6 hr-1 vs. 59 ± 6 μg·mL-1·6 hr-1; p = 0.03, FFA (2.46 ± 0.64 mmol·L-1·6 hr-1 vs. 1.57 ± 0.42 mmol·L-1·6 hr-1; p = 0.05, and kilocalorie expenditure (439 ± 26 kcal·6 hrs-1 vs. 380 ± 14 kcal·6 hrs-1; p = 0.02. No effect was noted for substrate utilization (p = 0.39. Both systolic and diastolic blood pressure

  12. 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

  13. [Genetic control of mitotic crossing-over in yeasts. III. Induction by 8-methoxypsoralen and long-wave UV irradiation (lambda=365 nm)].

    Science.gov (United States)

    Fedorova, I V; Marfin, S V

    1982-02-01

    The lethal effect of 8-methoxypsoralen (8-MOP) plus 365 nm light has been studied in haploid radiosensitive strains of Saccharomyces cerevisiae. The diploid of wild type and the diploid homozygous for the rad2 mutation (this mutation blocks the excision of UV-induced pyrimidine dimers) were more resistant to the lethal effect of 8-MOP plus 365 nm light than the haploid of wild type and rad2 haploid, respectively. The diploid homozygous for rad54 mutation (the mutation blocks the repair of double-strand breaks in DNA) was more sensitive than haploid rad54. The method of repeated irradiation allowed to study the capacity of radiosensitive diploids to remove monoadducts induced by 8-MOP in DNA. This process was very effective in diploids of wild type and in the rad54 rad54 diploid, while the rad2 rad2 diploid was characterized by nearly complete absence of monoadduct excision. The study of mitotic crossing over and mitotic segregation in yeast diploids, containing a pair of complementing alleles of the ade2 gene (red/pink) has shown a very high recombinogenic effect of 8-MOP plus 365 nm light. The rad2 mutation slightly increased the frequency of mitotic segregation and mitotic crossing over. The rad54 mutation decreased the frequency of mitotic segregation and entirely suppressed mitotic crossing over. The method of repeated irradiation showed that the cross-links, but not monoadducts, are the main cause of high recombinogenic effect of 8-MOP plus 365 nm light. The possible participation of different repair systems in recombinational processes induced by 8-MOP in yeast cells is discussed.

  14. Blind Analysis in Particle Physics

    International Nuclear Information System (INIS)

    Roodman, A

    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 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. The Effect of Nitrogen Cross-Over on Water Balance Measurements in Proton Exchange Membrane Fuel Cell Using Constant Temperature Anemometry

    DEFF Research Database (Denmark)

    Al Shakhshir, Saher; Berning, Torsten; Kær, Søren Knudsen

    2016-01-01

    A novel method to obtain an ad-hoc and real time electrical signal of the PEMFC water balance by employing a constant temperature hot wire anemometry has been developed by our fuel cell research group. In this work, the effect of nitrogen-cross over on this method is experimentally demonstrated...... by introducing 1% of nitrogen concentration to the dry and humidified hydrogen flow simulating the PEMFC anode outlet. The hot wire voltage is measured with and without nitrogen and it was slightly lower with the presence of nitrogen. The effect of the voltage reduction on the measured water balance is small...

  16. 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.

  17. 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.
.

  18. Effects of hand-training in persons with myotonic dystrophy type 1--a randomised controlled cross-over pilot study.

    Science.gov (United States)

    Aldehag, Anna; Jonsson, Hans; Lindblad, Jan; Kottorp, Anders; Ansved, Tor; Kierkegaard, Marie

    2013-10-01

    To investigate the effects of a hand-training programme on grip, pinch and wrist force, manual dexterity and activities of daily living, in adults with myotonic dystrophy type 1 (DM1). In this randomised controlled trial with a crossover design, 35 adults with DM1 were, after stratification for grip force, assigned by lot to two groups. Group A started with 12 weeks of hand training, while group B had no intervention. After a wash-out period of 12 weeks, where none received training, the order was reversed. The Grippit® was used as primary outcome measure and the hand-held Microfet2™ myometer, the Purdue Pegboard, the Canadian Occupational Performance Measure (COPM) and the Assessment of Motor and Process Skills (AMPS) were secondary outcome measures. Assessments were performed before and after training and control periods, i.e. four times altogether. Ten persons dropped out and 13 had acceptable adherence. Intention-to-treat analyses revealed significant intervention effects for isometric wrist flexor force (p = 0.048), and for COPM performance (p = 0.047) and satisfaction (p = 0.027). On an individual level, improvements were in general showed after a training period. The hand-training programme had positive effects on wrist flexor force and self-perception of occupational performance, and of satisfaction with performance. No evident detrimental effects were shown. Myotonic dystrophy type 1 (DM1) is a slowly progressive neuromuscular disease characterised by myotonia and muscle weakness and wasting. People with DM1 are often concerned about their ability to carry out ADL and to participate in, e.g. work, sports and hobbies when they gradually become weaker. This pilot study showed that a hand-training programme improved wrist flexor force and self-perception and satisfaction of occupational performance. Resistance training of hand muscles with a silicon-based putty can be a therapy option for people with DM1 in clinical practise.

  19. Blinding for unanticipated signatures

    NARCIS (Netherlands)

    D. Chaum (David)

    1987-01-01

    textabstractPreviously known blind signature systems require an amount of computation at least proportional to the number of signature types, and also that the number of such types be fixed in advance. These requirements are not practical in some applications. Here, a new blind signature technique

  20. "Color-Blind" Racism.

    Science.gov (United States)

    Carr, Leslie G.

    Examining race relations in the United States from a historical perspective, this book explains how the constitution is racist and how color blindness is actually a racist ideology. It is argued that Justice Harlan, in his dissenting opinion in Plessy v. Ferguson, meant that the constitution and the law must remain blind to the existence of race…

  1. Models for the blind

    DEFF Research Database (Denmark)

    Olsén, Jan-Eric

    2014-01-01

    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......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...... background to the tactile objects of the blind. When did they appear as a specific category of pedagogical aid and how did they help determine the relation between blindness, vision, and touch? Second, I address the tactile objects from the point of view of empirical sources and historical evidence. Material...

  2. Efficacy and safety of sacubitril/valsartan (LCZ696) in Japanese patients with chronic heart failure and reduced ejection fraction: Rationale for and design of the randomized, double-blind PARALLEL-HF study.

    Science.gov (United States)

    Tsutsui, Hiroyuki; Momomura, Shinichi; Saito, Yoshihiko; Ito, Hiroshi; Yamamoto, Kazuhiro; Ohishi, Tomomi; Okino, Naoko; Guo, Weinong

    2017-09-01

    The prognosis of heart failure patients with reduced ejection fraction (HFrEF) in Japan remains poor, although there is growing evidence for increasing use of evidence-based pharmacotherapies in Japanese real-world HF registries. Sacubitril/valsartan (LCZ696) is a first-in-class angiotensin receptor neprilysin inhibitor shown to reduce mortality and morbidity in the recently completed largest outcome trial in patients with HFrEF (PARADIGM-HF trial). The prospectively designed phase III PARALLEL-HF (Prospective comparison of ARNI with ACE inhibitor to determine the noveL beneficiaL trEatment vaLue in Japanese Heart Failure patients) study aims to assess the clinical efficacy and safety of LCZ696 in Japanese HFrEF patients, and show similar improvements in clinical outcomes as the PARADIGM-HF study enabling the registration of LCZ696 in Japan. This is a multicenter, randomized, double-blind, parallel-group, active controlled study of 220 Japanese HFrEF patients. Eligibility criteria include a diagnosis of chronic HF (New York Heart Association Class II-IV) and reduced ejection fraction (left ventricular ejection fraction ≤35%) and increased plasma concentrations of natriuretic peptides [N-terminal pro B-type natriuretic peptide (NT-proBNP) ≥600pg/mL, or NT-proBNP ≥400pg/mL for those who had a hospitalization for HF within the last 12 months] at the screening visit. The study consists of three phases: (i) screening, (ii) single-blind active LCZ696 run-in, and (iii) double-blind randomized treatment. Patients tolerating LCZ696 50mg bid during the treatment run-in are randomized (1:1) to receive LCZ696 100mg bid or enalapril 5mg bid for 4 weeks followed by up-titration to target doses of LCZ696 200mg bid or enalapril 10mg bid in a double-blind manner. The primary outcome is the composite of cardiovascular death or HF hospitalization and the study is an event-driven trial. The design of the PARALLEL-HF study is aligned with the PARADIGM-HF study and aims to assess

  3. 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…

  4. Memantine (a N-Methyl-D-aspartate receptor antagonist) in the treatment of neuropathic pain after amputation or surgery: A randomised, double-blinded, crossover study

    DEFF Research Database (Denmark)

    Nikolajsen, Lone; Gottrup, Hanne; Kristensen, Anders Due

    2000-01-01

    Evidence has accumulated that the N:-methyl-D-aspartate receptor system plays a role in continuous and particularly, in stimulus-evoked pain after nerve injury. We examined, in a randomized, double-blinded, cross-over fashion, the analgesic effect of memantine (a N:-methyl-D-aspartate receptor an...

  5. 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 (Pfruit intake significantly reduced genotoxicity in human faecal water relative to control (Pfruit may reduce colon cancer risk without inducing changes in the microbiota.

  6. 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.

  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 (P<0·0001), were more likely to prepare for the seminar (P<0·0001) and significantly preferred using ARS (P<0·0001). ARS was found to significantly improve student concentration and participation in small group seminar teaching and significantly improved knowledge retention. ARS may be useful in facilitating orthodontic teaching in the future.

  8. Acute and chronic effects of aquatic treadmill training on land treadmill running kinematics: A cross-over and single-subject design approach.

    Science.gov (United States)

    Bressel, Eadric; Louder, Talin J; Hoover, James P; Roberts, Luke C; Dolny, Dennis G

    2017-11-01

    The aim of this study was to determine if selected kinematic measures (foot strike index [SI], knee contact angle and overstride angle) were different between aquatic treadmill (ATM) and land treadmill (LTM) running, and to determine if these measures were altered during LTM running as a result of 6 weeks of ATM training. Acute effects were tested using 15 competitive distance runners who completed 1 session of running on each treadmill type at 5 different running speeds. Subsequently, three recreational runners completed 6 weeks of ATM training following a single-subject baseline, intervention and withdrawal experiment. Kinematic measures were quantified from digitisation of video. Regardless of speed, SI values during ATM running (61.3 ± 17%) were significantly greater (P = 0.002) than LTM running (42.7 ± 23%). Training on the ATM did not change (pre/post) the SI (26 ± 3.2/27 ± 3.1), knee contact angle (165 ± 0.3/164 ± 0.8) or overstride angle (89 ± 0.4/89 ± 0.1) during LTM running. Although SI values were different between acute ATM and LTM running, 6 weeks of ATM training did not appear to alter LTM running kinematics as evidenced by no change in kinematic values from baseline to post intervention assessments.

  9. 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...

  10. Blind loop syndrome

    Science.gov (United States)

    ... this page: //medlineplus.gov/ency/article/001146.htm Blind loop syndrome To use the sharing features on ... Clinical Professor of Medicine, The George Washington University School of Medicine, Washington, DC. Also reviewed by David ...

  11. Double blind randomized placebo-controlled trial on the effects of testosterone supplementation in elderly men with moderate to low testosterone levels: design and baseline characteristics [ISRCTN23688581

    Directory of Open Access Journals (Sweden)

    Verhaar Harald JJ

    2006-08-01

    Full Text Available Abstract In ageing men testosterone levels decline, while cognitive function, muscle and bone mass, sexual hair growth, libido and sexual activity decline and the risk of cardiovascular diseases increase. We set up a double-blind, randomized placebo-controlled trial to investigate the effects of testosterone supplementation on functional mobility, quality of life, body composition, cognitive function, vascular function and risk factors, and bone mineral density in older hypogonadal men. We recruited 237 men with serum testosterone levels below 13.7 nmol/L and ages 60–80 years. They were randomized to either four capsules of 40 mg testosterone undecanoate (TU or placebo daily for 26 weeks. Primary endpoints are functional mobility and quality of life. Secondary endpoints are body composition, cognitive function, aortic stiffness and cardiovascular risk factors and bone mineral density. Effects on prostate, liver and hematological parameters will be studied with respect to safety. Measure of effect will be the difference in change from baseline visit to final visit between TU and placebo. We will study whether the effect of TU differs across subgroups of baseline waist girth ( At baseline, mean age, BMI and testosterone levels were 67 years, 27 kg/m2 and 10.72 nmol/L, respectively.

  12. 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

  13. Rationale and design of a randomized double-blind clinical trial in breast cancer: dextromethorphan in chemotherapy-induced peripheral neuropathy.

    Science.gov (United States)

    Martin, Elodie; Morel, Véronique; Joly, Dominique; Villatte, Christine; Delage, Noémie; Dubray, Claude; Pereira, Bruno; Pickering, Gisèle

    2015-03-01

    Anti-cancer chemotherapy often induces peripheral neuropathy and consequent cognitive and quality of life impairment. Guidelines recommend antiepileptics or antidepressants but their efficacy is limited.Dextromethorphan, a N-methyl-D-aspartate receptor antagonist, has shown its efficacy in painful diabetic neuropathy and in post-operative pain but has not been studied in chemotherapy-induced peripheral neuropathy. This clinical trial evaluates the effect of dextromethorphan on pain, cognition and quality of life in patients who suffer from neuropathic pain induced by chemotherapy for breast cancer. It also assesses the impact of dextromethorphan genetic polymorphism on analgesia. This trial is a randomized, placebo-controlled, double-blind clinical study in two parallel groups (NCT02271893). It includes 40 breast cancer patients suffering from chemotherapy-induced peripheral neuropathy. They are randomly allocated to dextromethorphan (maximal dose 90 mg/day) or placebo for 4 weeks. The primary endpoint is pain intensity measured after 4 weeks of treatment on a (0-10) Numeric Pain Rating Scale. Secondary outcomes include assessment of neuropathic pain, cognitive function, anxiety/depression, sleep and quality of life. Data analysis is performed using mixed models and the tests are two-sided, with a type I error set at α=0.05. Considering the poor efficacy of available drugs in chemotherapy-induced neuropathic pain, dextromethorphan may be a valuable therapeutic option. Pharmacogenetics may provide predictive factors of dextromethorphan response in patients suffering from breast cancer. Copyright © 2015 Elsevier Inc. All rights reserved.

  14. 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 Basic Life Support-trained airway providers. © 2015 The Association of Anaesthetists of Great Britain and Ireland.

  15. 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

  16. 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.

  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. Mlh1 is required for female fertility in Drosophila melanogaster: An outcome of effects on meiotic crossing over, ovarian follicles and egg activation.

    Science.gov (United States)

    Vimal, Divya; Kumar, Saurabh; Pandey, Ashutosh; Sharma, Divya; Saini, Sanjay; Gupta, Snigdha; Ravi Ram, Kristipati; Chowdhuri, Debapratim Kar

    2018-03-01

    Mismatch repair (MMR) system, a conserved DNA repair pathway, plays crucial role in DNA recombination and is involved in gametogenesis. The impact of alterations in MMR family of proteins (bacterial MutS and MutL homologues) on mammalian fertility is well documented. However, an insight to the role of MMR in reproduction of non-mammalian organisms is limited. Hence, in the present study, we analysed the impact of mlh1 (a MutL homologue) on meiotic crossing over/recombination and fertility in a genetically tractable model, Drosophila melanogaster. Using mlh1 e00130 hypomorphic allele, we report female specific adverse reproductive outcome for reduced mlh1 in Drosophila: mlh1 e00130 homozygous females had severely reduced fertility while males were fertile. Further, mlh1 e00130 females contained small ovaries with large number of early stages as well as significantly reduced mature oocytes, and laid fewer eggs, indicating discrepancies in egg production and ovulation. These observations contrast the sex independent and/or male specific sterility and normal follicular development as well as ovulation reported so far for MMR family proteins in mammals. However, analogous to the role(s) of mlh1 in meiotic crossing over and DNA repair processes underlying mammalian fertility, ovarian follicles from mlh1 e00130 females contained significantly increased DNA double strand breaks (DSBs) and reduced synaptonemal complex foci. In addition, large proportion of fertilized eggs display discrepancies in egg activation and fail to proceed beyond stage 5 of embryogenesis. Hence, reduction of the Mlh1 protein level leads to defective oocytes that fail to complete embryogenesis after fertilization thereby reducing female fertility. Copyright © 2017 Elsevier GmbH. All rights reserved.

  19. Study for every other day administration of vonoprazan in maintenance treatment of erosive GERD: study protocol for a multicentre randomised cross-over study.

    Science.gov (United States)

    Kato, Mototsugu; Ito, Noriko; Demura, Mamiko; Kubo, Kimitoshi; Mabe, Katsuhiro; Harada, Naohiko

    2018-01-01

    The first drug selected for treatment of gastro-oesophageal reflux disease (GERD) and prevention of the recurrence is a proton pump inhibitor (PPI), but recently, a potassium-competitive acid blocker (P-CAB) was put on the market in Japan. Its onset of effect is faster than PPI, and it takes more than 2 days to recover acid secretion after the withdrawal period. Therefore, unlike PPI, the usefulness of every other day administration or discontinuous administration is expected. This study is a prospective, multicentre, open-label, two-period randomised cross-over study to compare the efficacy and safety of PPI every other day administration and P-CAB every other day administration in 120 patients who receive erosive GERD maintenance therapy with PPI. Patients will be randomly allocated to receive 4 weeks P-CAB or PPI followed by 4 weeks cross over, where those on P-CAB will receive PPI and vice versa. The primary endpoint is proportion of asymptomatic patients. Secondary endpoints are suppressive effect of GERD symptoms, proportion of asymptomatic patients at each time point, safety and cost-saving effect of P-CAB every other day administration, compliance with every other day administration, and proportion of asymptomatic patients at the first month of study drug administration. This study was approved by the National Hospital Organization Central Review Board for Clinical Trials (5 December 2017). If P-CAB every other day administration is established as one of GERD maintenance therapies, there is merit in both medical cost reduction and the safety to alleviate elevation in serum gastrin. UMIN000034701.

  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. 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...

  3. Environment and Blindness Situation in Iran

    Directory of Open Access Journals (Sweden)

    Soraya Askari

    2010-04-01

    Full Text Available Objectives: The purpose of this study is to describe the experiences of adults with acquired blindness while performing the daily activities of normal life and to investigated the role of environmental factors in this process. Methods: A qualitative phenomenological method has been designed for this study. A sample of 22 adults with acquired blindness who were blind for more than 5 years of life were purposefully selected and semi-structured in-depth interviews were conducted with them. The interviews were transcribed verbatim, coded and analyzed using van Manen’s method. Results: The five clustered themes that emerged from the interviews included: 1 Products and technology-discusses the benefits and drawbacks of using advanced technology to promote independence, 2 Physical environment-“The streets are like an obstacle course”, 3 Support and relationships-refers to the assistance that blind people receive from family, friends, and society, 4 Attitudes-includes family and social attitudes toward blind people, 5 Services and policies-social security, supportive acts, economic factors, educational problems and providing services. Discusion: Findings identify how the daily living activities of blind people are affected by environmental factors and what those factors are. The results will enable occupational therapists and other health care professionals who are involved with blind people to become more competent during assessment, counseling, teaching, giving support, or other interventions as needed to assist blind people. Recommendations for further research include more studies of this population to identify other challenges over time. This would facilitate long-term goals in the care. Studies that include more diversity in demographic characteristics would provide greater generalization. Some characteristics such as adolescent age group, married and single, ethnicity, and socioeconomic status are particularly important to target.

  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. A randomized controlled cross-over trial investigating the effect of anti-inflammatory diet on disease activity and quality of life in rheumatoid arthritis: the Anti-inflammatory Diet In Rheumatoid Arthritis (ADIRA) study protocol.

    Science.gov (United States)

    Winkvist, Anna; Bärebring, Linnea; Gjertsson, Inger; Ellegård, Lars; Lindqvist, Helen M

    2018-04-20

    Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects 0.5-1.0% of the population, and where many patients in spite of modern pharmacological treatment fail to reach remission. This affects physical as well as mental wellbeing and leads to severely reduced quality of life and reduced work capacity, thus yielding high individual as well as societal costs. As a complement to modern pharmacological treatment, lifestyle intervention should be evaluated as a treatment option. Scientific evidence exists for anti-inflammatory effects by single foods on RA, but no study exists where these foods have been combined to obtain maximum effect and thus offer a substantial improvement in patient life quality. The main goal of the randomized cross-over trial ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis) is to test the hypothesis that an anti-inflammatory diet intervention, compared to a regular diet, will decrease disease activity and improve quality of life in patients with stable established RA. In total, 50 RA patients with moderate disease activity are randomized to receive initially either a portfolio diet based on several food items with suggested anti-inflammatory effects or a control diet during 2 × 10 weeks with 3 months wash-out between diets. Food bags are delivered weekly by a home food delivery chain and referred to as the fiber bag and the protein bag, respectively, to partially blind participants. Both groups continue with regular pharmacological treatment. Known food biomarkers will be analyzed to measure intervention compliance. Impact on disease severity (measured by DAS28, a composite score which predicts disability and progression of RA), risk markers for cardiovascular disease and quality of life are evaluated after each diet regimen. Metabolomics will be used to evaluate the potential to predict responders to dietary treatment. A health economic evaluation is also included. The nutritional status of patients with RA often is

  6. Management of flu-like syndrome with cetirizine in patients with relapsing-remitting multiple sclerosis during therapy with interferon beta: Results of a randomized, cross-over, placebo-controlled pilot study.

    Directory of Open Access Journals (Sweden)

    Doriana Landi

    Full Text Available Flu-like syndrome (FLS is a common adverse event experienced by patients with relapsing-remitting multiple sclerosis (RRMS treated with interferon beta (IFNβ. FLS can lead to poor treatment adherence and early IFNβ discontinuation. The involvement of interleukin-6 (IL-6 in the occurrence of FLS has been suggested. We hypothesized that cetirizine, a second-generation histamine H1 receptor antagonist able to reduce the levels of IL-6, might improve IFNβ-induced FLS.We conducted a pilot, cross-over, randomized, placebo-controlled, double-blind study to evaluate the efficacy of cetirizine 10 mg added after each IFNβ injection to the standard of care for FLS (acetaminophen or nonsteroidal anti-inflammatory drugs on FLS in patients with RRMS treated with IFNβ. Patients were randomized to two treatment sequences: 1 4-week treatment with placebo added to the standard treatment for FLS, followed by 4-week treatment with cetirizine added to the standard of care, and 2 first addition of cetirizine, then of placebo. The primary efficacy endpoint was the mean change of FLS severity [11-point visual analog scale (VAS] after 4 weeks of treatment within each sequence.Forty-five patients (71.1% female, mean age 39.1 years, mean time from RRMS diagnosis 5.8 years were randomized to treatment sequences 1 and 2. The differences between cetirizine and placebo in the intensity of FLS were not statistically significant: total mean VAS scores at 4 hours from IFNβ injection were 3.57 and 3.42 for cetirizine and placebo, respectively (difference -0.15; 95% confidence interval: from -0.74 to 0.44; p = 0.6029. The two treatments were similar also with regard to other efficacy measures considered and to the safety/tolerability profile.The addition of cetirizine to the standard of care for IFNβ-induced FLS in patients with RRMS does not seem to provide significant benefits compared with placebo. Further effort is required to understand the mechanisms underlying IFN

  7. Blind spot detection & passive lane change assist systems

    NARCIS (Netherlands)

    Surovtcev, I.

    2015-01-01

    The project goal was design and implementation of proof-of-concept for two systems that aim to tackle the blind spot problem of for the commercial vehicles: Blind Spot Detection and Passive Lane Change Assist functions. The system implementation was done using Rapid Control Prototype (RCP) hardware.

  8. 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 ...

  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

    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. 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

    Probiotics, prebiotics, and combinations thereof, that is synbiotics, have been reported to modulate gut microbiota of humans. In this study, effects of a novel synbiotic on the composition and metabolic activity of human gut microbiota were investigated. Healthy volunteers (n=18) were enrolled i...

  11. Effect of combination therapy with thyroxine (T4) and 3,5,3'-triiodothyronine versus T4 monotherapy in patients with hypothyroidism, a double-blind, randomised cross-over study

    DEFF Research Database (Denmark)

    Nygaard, Birte; Jensen, Ebbe Winther; Kvetny, Jan

    2009-01-01

    BACKGROUND: Treatment of hypothyroidism with 3,5,3'-triiodothyronine (T(3)) is controversial. A recent meta-analysis concludes that no evidence is present in favour of using T(3). However, the analysis included a mixture of different patient groups and dose-regimens. OBJECTIVE: To compare the eff...

  12. Comparison of chest compressions in the standing position beside a bed at knee level and the kneeling position: a non-randomised, single-blind, cross-over trial.

    Science.gov (United States)

    Oh, Je Hyeok; Kim, Chan Woong; Kim, Sung Eun; Lee, Sang Jin; Lee, Dong Hoon

    2014-07-01

    When rescuers perform cardiopulmonary resuscitation (CPR) from a standing position, the height at which chest compressions are carried out is raised. To determine whether chest compressions delivered on a bed adjusted to rescuer's knee height are as effective as those delivered on the floor. A total of 20 fourth-year medical students participated in the study. The students performed chest compressions for 2 min each on a manikin lying on the floor (test 1) and on a manikin lying on a bed (test 2). The average compression rate (ACR) and the average compression depth (ACD) were compared between the two tests. The ACR was not significantly different between tests 1 and 2 (120.1 to 132.9  vs 115.7 to 131.2 numbers/min, 95% CI, p=0.324). The ACD was also not significantly different between tests 1 and 2 (51.2 to 56.6 vs 49.4 to 55.7 mm, 95% CI, p=0.058). The results suggest that there may be no significant differences in compression rate and depth between CPR performed on manikins placed on the floor and those placed at a rescuer's knee height. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  13. Effective cross-over to granisetron after failure to ondansetron, a randomized double blind study in patients failing ondansetron plus dexamethasone during the first 24 hours following highly emetogenic chemotherapy

    NARCIS (Netherlands)

    R. de Wit (Ronald); A.C. de Boer (Auke); G.H.M. Vd Linden (G. H M); G. Stoter (Gerrit); A. Sparreboom (Alex); J. Verweij (Jaap)

    2001-01-01

    textabstractIn view of the similarity in chemical structure of the available 5HT 3-receptor antagonists it is assumed, whilst these agents all act at the same receptor, that failure to one agent would predict subsequent failure to all 5HT 3-receptor antagonists. We conducted a randomized double

  14. 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

    ), after which they switched to the corresponding treatment for a further three months period (Phase 2). Before entering the study, after 3 weeks and following three months of each of the study phases, scores for pain, stiffness and general feeling of discomfort were evaluated using a 10 step categorical......), showed a reduction in pain, as compared to 36% in the group B initially given placebo (p ... subjects 3 weeks after the switch to placebo. The consumption of rescue medication such as paracetamol, codeine and tramadol also declined significantly in group A when compared to group B (p

  15. 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 randomize....... reuteri do not seem to modulate the salivary oral immune response in healthy young subjects (ClinicalTrials.gov NCT02017886).......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...... and 3 weeks post-intervention levels. No side- or adverse effects were reported. Conclusions: 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...

  16. 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-...

  17. 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.

  18. 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....... The intervention had no effect on reaction time or any of the mood-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...

  19. 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

  20. 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.

  1. Adherence and acceptability in MTN 001: A randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women

    Science.gov (United States)

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

    2012-01-01

    We compared adherence to and acceptability of daily topical and oral formulations of tenofovir (TFV) used as pre-exposure prophylaxis (PrEP) for HIV prevention among women in South Africa, Uganda and the United States. 144 sexually active, HIV-uninfected women participated in a cross-over study of three regimens: oral tablet, vaginal gel, or both. We tested for differences in adherence and evaluated product acceptability. Self-reported adherence for all regimens was high (94%), but serum TFV concentrations indicated only 64% of participants used tablets consistently. Most women in the U.S. (72%) favored tablets over gel; while preferences varied at the African sites (42% preferred gel and 40% tablets). Findings indicate a role for oral and vaginal PrEP formulations and highlight the importance of integrating pharmacokinetics-based adherence assessment in future trials. Biomedical HIV prevention interventions should consider geographic and cultural experience with product formulations, partner involvement, and sexual health benefits that ultimately influence use. PMID:23065145

  2. 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

  3. 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.

  4. Heart rate variability during acute psychosocial stress: A randomized cross-over trial of verbal and non-verbal laboratory stressors.

    Science.gov (United States)

    Brugnera, Agostino; Zarbo, Cristina; Tarvainen, Mika P; Marchettini, Paolo; Adorni, Roberta; Compare, Angelo

    2018-05-01

    Acute psychosocial stress is typically investigated in laboratory settings using protocols with distinctive characteristics. For example, some tasks involve the action of speaking, which seems to alter Heart Rate Variability (HRV) through acute changes in respiration patterns. However, it is still unknown which task induces the strongest subjective and autonomic stress response. The present cross-over randomized trial sought to investigate the differences in perceived stress and in linear and non-linear analyses of HRV between three different verbal (Speech and Stroop) and non-verbal (Montreal Imaging Stress Task; MIST) stress tasks, in a sample of 60 healthy adults (51.7% females; mean age = 25.6 ± 3.83 years). Analyses were run controlling for respiration rates. Participants reported similar levels of perceived stress across the three tasks. However, MIST induced a stronger cardiovascular response than Speech and Stroop tasks, even after controlling for respiration rates. Finally, women reported higher levels of perceived stress and lower HRV both at rest and in response to acute psychosocial stressors, compared to men. Taken together, our results suggest the presence of gender-related differences during psychophysiological experiments on stress. They also suggest that verbal activity masked the vagal withdrawal through altered respiration patterns imposed by speaking. Therefore, our findings support the use of highly-standardized math task, such as MIST, as a valid and reliable alternative to verbal protocols during laboratory studies on stress. Copyright © 2018 Elsevier B.V. All rights reserved.

  5. 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.

  6. 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

  7. 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; Ruiz Carrascal, Jorge; Raben, Anne; Aaslyng, Margit D

    2017-08-26

    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.

  8. Whole grain-rich diet reduces body weight and systemic low-grade inflammation without inducing major changes of the gut microbiome: a randomised cross-over trial.

    Science.gov (United States)

    Roager, Henrik Munch; Vogt, Josef K; Kristensen, Mette; Hansen, Lea Benedicte S; Ibrügger, Sabine; Mærkedahl, Rasmus B; Bahl, Martin Iain; Lind, Mads Vendelbo; Nielsen, Rikke L; Frøkiær, Hanne; Gøbel, Rikke Juul; Landberg, Rikard; Ross, Alastair B; Brix, Susanne; Holck, Jesper; Meyer, Anne S; Sparholt, Morten H; Christensen, Anders F; Carvalho, Vera; Hartmann, Bolette; Holst, Jens Juul; Rumessen, Jüri Johannes; Linneberg, Allan; Sicheritz-Pontén, Thomas; Dalgaard, Marlene D; Blennow, Andreas; Frandsen, Henrik Lauritz; Villas-Bôas, Silas; Kristiansen, Karsten; Vestergaard, Henrik; Hansen, Torben; Ekstrøm, Claus T; Ritz, Christian; Nielsen, Henrik Bjørn; Pedersen, Oluf Borbye; Gupta, Ramneek; Lauritzen, Lotte; Licht, Tine Rask

    2017-11-01

    To investigate whether a whole grain diet alters the gut microbiome and insulin sensitivity, as well as biomarkers of metabolic health and gut functionality. 60 Danish adults at risk of developing metabolic syndrome were included in a randomised cross-over trial with two 8-week dietary intervention periods comprising whole grain diet and refined grain diet, separated by a washout period of ≥6 weeks. The response to the interventions on the gut microbiome composition and insulin sensitivity as well on measures of glucose and lipid metabolism, gut functionality, inflammatory markers, anthropometry and urine metabolomics were assessed. 50 participants completed both periods with a whole grain intake of 179±50 g/day and 13±10 g/day in the whole grain and refined grain period, respectively. Compliance was confirmed by a difference in plasma alkylresorcinols (pgut microbiome but reduced body weight and systemic low-grade inflammation. NCT01731366; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  9. 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.

  10. 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.

  11. 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...

  12. Xanthophylls, phytosterols and pre-β1-HDL are differentially affected by fenofibrate and niacin HDL-raising in a cross-over study.

    Science.gov (United States)

    Niesor, Eric J; Gauthamadasa, Kekulawalage; Silva, R A Gangani D; Suchankova, Gabriela; Kallend, David; Gylling, Helena; Asztalos, Bela; Damonte, Elisabetta; Rossomanno, Simona; Abt, Markus; Davidson, W Sean; Benghozi, Renee

    2013-12-01

    Fenofibrate and extended-release (ER) niacin similarly raise high-density lipoprotein cholesterol (HDL-C) concentration but their effects on levels of potent plasma antioxidant xanthophylls (lutein and zeaxanthin) and phytosterols obtained from dietary sources, and any relationship with plasma lipoproteins and pre-β1-HDL levels, have not been investigated. We studied these parameters in 66 dyslipidemic patients treated for 6 week with fenofibrate (160 mg/day) or ER-niacin (0.5 g/day for 3 week, then 1 g/day) in a cross-over study. Both treatments increased HDL-C (16 %) and apolipoprotein (apo) A-I (7 %) but only fenofibrate increased apoA-II (28 %). Lutein and zeaxanthin levels were unaffected by fenofibrate but inversely correlated with percentage change in apoB and low-density lipoprotein cholesterol and positively correlated with end of treatment apoA-II. ApoA-II in isolated HDL in vitro bound more lutein than apoA-I. Xanthophylls were increased by ER-niacin (each ~30 %) without any correlation to lipoprotein or apo levels. Only fenofibrate markedly decreased plasma markers of cholesterol absorption; pre-β1-HDL was significantly decreased by fenofibrate (-19 %, p xanthophylls, phytosterols and pre-β1-HDL differed markedly, suggesting differences in intestinal lipidation of HDL. In addition, the in vitro investigations suggest an important role of plasma apoA-II in xanthophyll metabolism.

  13. 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-corticotrophine releasing hormone test and other potential endophenotypes in healthy first-degree relatives of persons with depression

    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...

  14. 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.

  15. Study design and rationale of "Synergistic Effect of Combination Therapy with Cilostazol and ProbUcol on Plaque Stabilization and Lesion REgression (SECURE" study: a double-blind randomised controlled multicenter clinical trial

    Directory of Open Access Journals (Sweden)

    Lee Myoungsook

    2011-01-01

    Full Text Available Abstract Background Probucol, a cholesterol-lowering agent that paradoxically also lowers high-density lipoprotein cholesterol has been shown to prevent progression of atherosclerosis. The antiplatelet agent cilostazol, which has diverse antiatherogenic properties, has also been shown to reduce restenosis in previous clinical trials. Recent experimental studies have suggested potential synergy between probucol and cilostazol in preventing atherosclerosis, possibly by suppressing inflammatory reactions and promoting cholesterol efflux. Methods/design The Synergistic Effect of combination therapy with Cilostazol and probUcol on plaque stabilization and lesion REgression (SECURE study is designed as a double-blind, randomised, controlled, multicenter clinical trial to investigate the effect of cilostazol and probucol combination therapy on plaque volume and composition in comparison with cilostazol monotherapy using intravascular ultrasound and Virtual Histology. The primary end point is the change in the plaque volume of index intermediate lesions between baseline and 9-month follow-up. Secondary endpoints include change in plaque composition, neointimal growth after implantation of stents at percutaneous coronary intervention target lesions, and serum levels of lipid components and biomarkers related to atherosclerosis and inflammation. A total of 118 patients will be included in the study. Discussion The SECURE study will deliver important information on the effects of combination therapy on lipid composition and biomarkers related to atherosclerosis, thereby providing insight into the mechanisms underlying the prevention of atherosclerosis progression by cilostazol and probucol. Trial registration number ClinicalTrials (NCT: NCT01031667

  16. Oplysningens blinde vinkler

    DEFF Research Database (Denmark)

    Hendricks, Vincent Fella; Hansen, Pelle Guldborg

    manipulation og fordrejning, til at påvirke menneskers overvejelser, beslutninger og handlinger, både individuelt og kollektivt, hvilket i sidste ende kan få betydning for de demokratiske processer. Oplysningens blinde vinkler gennemgår en række informationsfænomener, som optræder i vores dagligdag, og den...

  17. Leading Causes of Blindness

    Science.gov (United States)

    ... have cataracts. They are the leading cause of blindness in the world. By age 80, more than half of all people in the United States either will have a cataract or have had cataract surgery. Common symptoms are: Blurry vision Colors that seem faded Glare Not being able to ...

  18. Blind Loop Syndrome

    Science.gov (United States)

    ... or scleroderma involving the small intestine History of radiation therapy to the abdomen Diabetes Diverticulosis of the small intestine Complications A blind loop can cause escalating problems, including: Poor absorption of fats. Bacteria in your small intestine break down the bile ...

  19. Stochastic Blind Motion Deblurring

    KAUST Repository

    Xiao, Lei; Gregson, James; Heide, Felix; Heidrich, Wolfgang

    2015-01-01

    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

  20. 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.

  1. 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.

  2. 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.

  3. 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...

  4. The blind leading the blind: use and misuse of blinding in randomized controlled trials.

    Science.gov (United States)

    Miller, Larry E; Stewart, Morgan E

    2011-03-01

    The use of blinding strengthens the credibility of randomized controlled trials (RCTs) by minimizing bias. However, there is confusion surrounding the definition of blinding as well as the terms single, double, and triple blind. It has been suggested that these terms should be discontinued due to their broad misinterpretation. We recommend that, instead of abandoning the use of these terms, explicit definitions of blinding should be adopted. We address herein the concept of blinding, propose standard definitions for the consistent use of these terms, and detail when different types of blinding should be utilized. Standardizing the definition of blinding and utilizing proper blinding methods will improve the quality and clarity of reporting in RCTs. Copyright © 2010 Elsevier Inc. All rights reserved.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. Single-implant overdentures retained by the Novaloc attachment system: study protocol for a mixed-methods randomized cross-over trial.

    Science.gov (United States)

    de Souza, Raphael F; Bedos, Christophe; Esfandiari, Shahrokh; Makhoul, Nicholas M; Dagdeviren, Didem; Abi Nader, Samer; Jabbar, Areej A; Feine, Jocelyne S

    2018-04-23

    Overdentures retained by a single implant in the midline have arisen as a minimal implant treatment for edentulous mandibles. The success of this treatment depends on the performance of a single stud attachment that is susceptible to wear-related retention loss. Recently developed biomaterials used in attachments may result in better performance of the overdentures, offering minimal retention loss and greater patient satisfaction. These biomaterials include resistant polymeric matrixes and amorphous diamond-like carbon applied on metallic components. The objective of this explanatory mixed-methods study is to compare Novaloc, a novel attachment system with such characteristics, to a traditional alternative for single implants in the mandible of edentate elderly patients. We will carry out a randomized cross-over clinical trial comparing Novaloc attachments to Locators for single-implant mandibular overdentures in edentate elderly individuals. Participants will be followed for three months with each attachment type; patient-based, clinical, and economic outcomes will be gathered. A sample of 26 participants is estimated to be required to detect clinically relevant differences in terms of the primary outcome (patient ratings of general satisfaction). Participants will choose which attachment they wish to keep, then be interviewed about their experiences and preferences with a single implant prosthesis and with the two attachments. Data from the quantitative and qualitative assessments will be integrated through a mixed-methods explanatory strategy. A last quantitative assessment will take place after 12 months with the preferred attachment; this latter assessment will enable measurement of the attachments' long-term wear and maintenance requirements. Our results will lead to evidence-based recommendations regarding these systems, guiding providers and patients when making decisions on which attachment systems and implant numbers will be most appropriate for

  11. A dose-finding, cross-over study to evaluate the effect of a Nestorone®/Estradiol transdermal gel delivery on ovulation suppression in normal ovulating women.

    Science.gov (United States)

    Brache, Vivian; Merkatz, Ruth; Kumar, Narender; Jesam, Cristian; Sussman, Heather; Hoskin, Elena; Roberts, Kevin; Alami, Mohcine; Taylor, Deshawn; Jorge, Aidelis; Croxatto, Horacio; Lorange, Ellen; Mishell, Daniel R; Sitruk-Ware, Regine

    2015-10-01

    This study aims to determine the lowest effective of three Nestorone (NES)/estradiol (E2) transdermal gel doses to ensure ovulation suppression in 90-95% of cycles. This was a randomized, open-label, three-treatment-period cross-over study to evaluate the effects of NES/E2 transdermal gel on ovulation inhibition, suppression of follicular growth and pharmacokinetic parameters. The doses were low (1.5 mg NES/0.5 mg E2), medium (3.0 mg NES/1.0 mg E2) and high (4.5 mg NES/1.5 mg E2). Participants applied gel daily to a fixed area on the abdomen for 21 consecutive days. They were interviewed regarding their experiences using the gel. Eighteen participants were randomized; 16 completed the study. Median NES C(max) values for low, medium and high dose groups at day 21 were 318.6 pmol/L, 783.0 pmol/L and 1063.8 pmol/L, respectively. Median maximum follicular diameter was higher with the lowest dose with 16.2 mm versus 10.0 and 10.4 mm with the medium and high doses, respectively. Among adherent participants, ovulation was inhibited in all dose groups, except for one participant in the medium dose (6.7%) that had luteal activity and an ultrasound image suggestive of a luteinized unruptured follicle. There were few reports of unscheduled bleeding, with more episodes reported for the lower dose. Adverse events were mild, and no skin irritation was reported from gel application. While all three doses blocked ovulation effectively and were evaluated as safe and acceptable, the medium dose was considered the lowest effective dose based on a more adequate suppression of follicular development. Further development of this novel contraceptive delivering NES and E2 is warranted and has potential for improved safety compared to ethinyl-estradiol-based methods. Copyright © 2015 Elsevier Inc. All rights reserved.

  12. LDL-cholesterol lowering effect of a new dietary supplement: an open label, controlled, randomized, cross-over clinical trial in patients with mild-to-moderate hypercholesterolemia.

    Science.gov (United States)

    Magno, S; Ceccarini, G; Pelosini, C; Jaccheri, R; Vitti, J; Fierabracci, P; Salvetti, G; Airoldi, G; Minale, M; Saponati, G; Santini, F

    2018-05-24

    Hypercholesterolemia is a major risk factor for cardiovascular disorders and requires specific intervention through an adequate lifestyle (diet and physical exercise) and, if necessary, an appropriate drug treatment. Lipid-lowering drugs, although generally efficacious, may sometimes cause adverse events. A growing attention has been devoted to the correction of dyslipidemias through the use of dietary supplements. The aim of this study was to assess the lipid-lowering activity and safety of a dietary supplement containing monacolin K, L-arginine, coenzyme Q10 and ascorbic acid, named Argicolina (A), compared to a commercially available product containing monacolin K and coenzyme Q10, Normolip 5 (N). This was a single center, controlled, randomized, open-label, cross-over clinical study enrolling 20 Caucasian outpatients aged 18-75 years with serum LDL-C between 130 and 180 mg/dL. Patients assumed two different dietary supplements (A and N) both containing monacolin K 10 mg for 8 weeks each, separated by a 4-week wash-out period. Evaluated parameters were: Total cholesterol (Tot-C), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), triglycerides (TG), fasting blood glucose, aspartate aminotransferase, alanine aminotransferase, creatinekinase, gamma-glutamyl-transpeptidase, brachial arterial pressure and heart rate, measured at the start and at the end of each treatment period. Safety was monitored through the study. LDL-C decreased by 23.3% during treatment with N (p ascorbic acid also produces a significant reduction of triglycerides without significant effects on HDL. ClinicalTrials.gov ID: NCT03425630 .

  13. Eye diseases and blindness in Adjumani refugee settlement camps ...

    African Journals Online (AJOL)

    East African Medical Journal ... and; to device administrative strategies and logistics of prevention and control of blinding ... Design: A mobile outreach clinic study for six weeks. ... Interventions: Medical treatment and surgical correction offered.

  14. 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.

  15. 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.

  16. 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

  17. 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.

  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. 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

  20. Comparison of preservative-free latanoprost and preservative-free bimatoprost in a multicenter, randomized, investigator-masked cross-over clinical trial, the SPORT trial.

    Science.gov (United States)

    Stalmans, Ingeborg; Oddone, Francesco; Cordeiro, Maria Francesca; Hommer, Anton; Montesano, Giovanni; Ribeiro, Luisa; Sunaric-Mégevand, Gordana; Rossetti, Luca

    2016-06-01

    The aim of this study was to investigate the efficacy and safety of Bimatoprost Unit Dose Preservative Free (BUDPF) and Latanoprost Unit Dose Preservative Free (LUDPF). A prospective, randomized, investigator-masked, cross-over comparison was used. Inclusion criteria were ocular hypertension (OHT) or open-angle glaucoma (OAG) with a maximum intraocular pressure (IOP) of 21 mmHg on a preserved prostaglandin monotherapy. After 6 weeks washout, patients were randomized to BUDPF or LUDPF for 3 months and then switched to the other treatment for 3 months. IOP curves were performed at baseline and after each treatment period. Statistical analysis was performed in a R programming environment. Linear mixed modeling was used to account for repeated measures on the same subject and clustering of observations from the same center. Safety outcomes included visual acuity, adverse events, slit-lamp biomicroscopy, ocular tolerability, and optic nerve assessment. Analysis at 6 months (primary outcome) showed a 1.6 ± 0.5-mmHg difference in IOP values between LUDPF and BUDPF (p < 0.01). A mean intra-subject IOP difference of 0.9 ± 0.2 mmHg (LUDPF - BUDPF) was observed (p < 0.01).. Significant differences in IOP were observed for both drugs at 3 and at 6 months compared to baseline: -4,0 ± 0.5 mmHg for both BUDPF and LUDPF at 3 months (p < 0.01 for both drugs; p = 0.32 between the two drugs); -5.2 ± 0.5 and -3.4 ± 0.5 mmHg for BUDPF and LUDPF, respectively (both p < 0.01), at 6 months. Both drugs were tolerated well, the only statistically significant difference being lower hyperemia scores for LUDPF (albeit low for both drugs). This study demonstrates a superior efficacy of BUDPF over LUDPF in lowering IOP. The results are consistent both in the parallel comparison between the two treatment groups at 6 months as well as in the intra-subject pressure comparison.

  1. Perception of blindness and blinding eye conditions in rural communities.

    Science.gov (United States)

    Ashaye, Adeyinka; Ajuwon, Ademola Johnson; Adeoti, Caroline

    2006-01-01

    PURPOSE: The purpose of this qualitative study was to explore the causes and management of blindness and blinding eye conditions as perceived by rural dwellers of two Yoruba communities in Oyo State, Nigeria. METHODS: Four focus group discussions were conducted among residents of Iddo and Isale Oyo, two rural Yoruba communities in Oyo State, Nigeria. Participants consisted of sighted, those who were partially or totally blind and community leaders. Ten patent medicine sellers and 12 traditional healers were also interviewed on their perception of the causes and management of blindness in their communities. FINDINGS: Blindness was perceived as an increasing problem among the communities. Multiple factors were perceived to cause blindness, including germs, onchocerciasis and supernatural forces. Traditional healers believed that blindness could be cured, with many claiming that they had previously cured blindness in the past. However, all agreed that patience was an important requirement for the cure of blindness. The patent medicine sellers' reports were similar to those of the traditional healers. The barriers to use of orthodox medicine were mainly fear, misconception and perceived high costs of care. There was a consensus of opinion among group discussants and informants that there are severe social and economic consequences of blindness, including not been able to see and assess the quality of what the sufferer eats, perpetual sadness, loss of sleep and dependence on other persons for daily activities. CONCLUSION: Local beliefs associated with causation, symptoms and management of blindness and blinding eye conditions among rural Yoruba communities identified have provided a bridge for understanding local perspectives and basis for implementing appropriate primary eye care programs. PMID:16775910

  2. 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.

  3. 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.

  4. Psychological and social adjustment to blindness: understanding from two groups of blind people in Ilorin, Nigeria.

    Science.gov (United States)

    Tunde-Ayinmode, Mosunmola F; Akande, Tanimola M; Ademola-Popoola, Dupe S

    2011-01-01

    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 personalized and depends on nature and quality of prevailing psychosocial support and rehabilitation opportunities. This study was aimed at identifying the pattern of psychosocial adjustment in a group of relatively secluded and under-reached totally blind people in Ilorin, thus sensitizing eye doctors to psychosocial morbidity and care in the blind. A cross-sectional descriptive study using 20-item Self-Reporting Questionnaire (SRQ) and a pro forma designed by the authors to assess the psychosocial problems and risk factors in some blind people in Ilorin metropolis. The study revealed that most of the blind people were reasonably adjusted in key areas of social interaction, marriage, and family. Majority were considered to be poorly adjusted in the areas of education, vocational training, employment, and mobility. Many were also considered to be psychologically maladjusted based on the high rate of probable psychological disorder of 51%, as determined by SRQ. Factors identified as risk factors of probable psychological disorder were poor educational background and the presence of another medical disorder. Most of the blind had no access to formal education or rehabilitation system, which may have contributed to their maladjustment in the domains identified. Although their prevailing psychosocial situation would have been better prevented yet, real opportunity still exists to help this group of people in the area of social and physical rehabilitation, meeting medical needs, preventive psychiatry, preventive ophthalmology, and community health. This will require the joint efforts of medical community, government and nongovernment organizations to provide the framework for delivery of these services directly to the communities.

  5. 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.

  6. 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.

  7. Motor development of blind toddler

    OpenAIRE

    Likar, Petra

    2013-01-01

    For blind toddlers, development of motor skills enables possibilities for learning and exploring the environment. The purpose of this graduation thesis is to systematically mark the milestones in development of motor skills in blind toddlers, to establish different factors which affect this development, and to discover different ways for teachers for visually impaired and parents to encourage development of motor skills. It is typical of blind toddlers that they do not experience a wide varie...

  8. Wearable Assistive Devices for the Blind

    OpenAIRE

    Velazquez, Ramiro

    2016-01-01

    Assistive devices are a key aspect in wearable systems for biomedical applications, as they represent potential aids for people with physical and sensory disabilities that might lead to improvements in the quality of life. This chapter focuses on wearable assistive devices for the blind. It intends to review the most significant work done in this area, to present the latest approaches for assisting this population and to understand universal design concepts for the development of wearable ass...

  9. 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.

  10. Design and methods for the Better Resiliency Among Veterans and non-Veterans with Omega-3's (BRAVO) study: A double blind, placebo-controlled trial of omega-3 fatty acid supplementation among adult individuals at risk of suicide.

    Science.gov (United States)

    Marriott, Bernadette P; Hibbeln, Joseph R; Killeen, Therese K; Magruder, Kathryn M; Holes-Lewis, Kelly; Tolliver, Bryan K; Turner, Travis H

    2016-03-01

    Suicide remains the 10th leading cause of death among adults in the United States (U.S.). Annually, approximately 30 per 100,000 U.S. military Veterans commit suicide, compared to 14 per 100,000 U.S. civilians. Symptoms associated with suicidality can be treatment resistant and proven-effective pharmaceuticals may have adverse side-effects. Thus, a critical need remains to identify effective approaches for building psychological resiliency in at-risk individuals. Omega-3 highly unsaturated fatty acids (n-3 HUFAs) are essential nutrients, which must be consumed in the diet. N-3 HUFAs have been demonstrated to reduce symptoms of depression, anxiety, and impulsivity - which are associated with suicide risk. Here we present the design and methods for the Better Resiliency Among Veterans and non-Veterans with Omega-3's (BRAVO) study, which is a double blind, randomized, controlled trial among individuals at risk of suicide of an n-3 HUFA versus placebo supplementation in the form of all natural fruit juice beverages. The BRAVO study seeks to determine if dietary supplementation with n-3 HUFAs reduces the risk for serious suicidal behaviors, suicidal thinking, negative emotions, and symptoms associated with suicide risk. Sub-analyses will evaluate efficacy in reducing depressive symptoms, alcohol, and nicotine use. A sub-study utilizes functional magnetic resonance imaging (fMRI) to evaluate the neuropsychological and neurophysiological effects of n-3 HUFAs. We also outline selection of appropriate proxy outcome measures for detecting response to treatment and collection of ancillary data, such as diet and substance use, that are critical for interpretation of results. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. 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.

  12. 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....

  13. 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

  14. 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

  15. 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...

  16. 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...

  17. 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.

  18. Libertas: rationale and study design of a multicentre, Phase II, double-blind, randomised, placebo-controlled investigation to evaluate the efficacy, safety and tolerability of locally applied NRL001 in patients with faecal incontinence.

    Science.gov (United States)

    Siproudhis, L; Jones, D; Shing, R Ng Kwet; Walker, D; Scholefield, J H

    2014-03-01

    Faecal incontinence affects up to 8% of adults. Associated social isolation and subsequent depression can have devastating effects on quality of life (QoL). Faecal incontinence is an underreported health problem as the social isolation and stigma that patients experience makes it difficult for sufferers to discuss their condition with a physician. There have been few well-designed, placebo-controlled clinical trials of treatment for faecal incontinence and little clinical evidence is available to inform the most appropriate management strategies. Libertas, a robustly designed study will investigate the efficacy and safety of NRL001 (1R,2S-methoxamine), an α1 -adrenoceptor agonist, in the treatment of faecal incontinence. Libertas is a multicentre, Phase II, double-blind, randomised, placebo-controlled, parallel group study. Patient recruitment took place across 55 study centres in Europe. Patients suffering with faecal incontinence were randomised into four groups (approximately 110 each) to receive once daily self-administered doses of NRL001 (5, 7.5 or 10 mg or placebo in a suppository formulation) for 8 weeks. The primary objective of Libertas is to assess the impact of once daily administration of NRL001 on the severity and frequency of incontinence episodes as assessed by the Wexner score at 4 weeks, compared with placebo. Secondary outcomes include measures of efficacy of NRL001 compared with placebo following 8 weeks treatment; safety and tolerability; evaluation of plasma pharmacokinetics; establishment of any pharmacokinetic/pharmacodynamic relationship to adverse events; dose-response relationship; the efficacy of NRL001 therapy at 4 and 8 weeks assessed by the Vaizey score; and QoL using the Faecal Incontinence Quality of Life and the EQ-5D-5L Healthcare Questionnaires following 4 and 8 weeks NRL001 therapy. Overall patient satisfaction with the treatment will also be evaluated. This is the first randomised controlled study to investigate the efficacy

  19. 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, 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.

  20. 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.

  1. Testing Children for Color Blindness

    Science.gov (United States)

    ... Stories Español Eye Health / News Testing Children for Color Blindness Leer en Español: Pruebas para Detectar Daltonismo en ... study shows that kids can be tested for color blindness as soon as age 4, finds Caucasian boys ...

  2. Culture and change blindness.

    Science.gov (United States)

    Masuda, Takahiko; Nisbett, Richard E

    2006-03-04

    Research on perception and cognition suggests that whereas East Asians view the world holistically, attending to the entire field and relations among objects, Westerners view the world analytically, focusing on the attributes of salient objects. These propositions were examined in the change-blindness paradigm. Research in that paradigm finds American participants to be more sensitive to changes in focal objects than to changes in the periphery or context. We anticipated that this would be less true for East Asians and that they would be more sensitive to context changes than would Americans. We presented participants with still photos and with animated vignettes having changes in focal object information and contextual information. Compared to Americans, East Asians were more sensitive to contextual changes than to focal object changes. These results suggest that there can be cultural variation in what may seem to be basic perceptual processes. 2006 Lawrence Erlbaum Associates, Inc.

  3. 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.

  4. Does the ingestion of a 24 hour low glycaemic index Asian mixed meal diet improve glycaemic response and promote fat oxidation? A controlled, randomized cross-over study.

    Science.gov (United States)

    Camps, Stefan Gerardus; Kaur, Bhupinder; Quek, Rina Yu Chin; Henry, Christiani Jeyakumar

    2017-07-12

    The health benefits of consuming a low glycaemic index (GI) diet to reduce the risk of type 2 Diabetes are well recognized. In recent years the GI values of various foods have been determined. Their efficacy in constructing and consuming a low GI diet over 24 h in modulating glycaemic response has not been fully documented. The translation of using single-point GI values of foods to develop a 24 h mixed meal diet can provide valuable information to consumers, researchers and dietitians to optimize food choice for glycaemic control. By using GI values of foods to develop mixed meals, our study is the first to determine how both blood glucose and substrate oxidation may be modulated over 24 h. The study included 11 Asian men with a BMI between 17-24 kg/m 2 who followed both a 1-day low GI and 1-day high GI diet in a randomized, controlled cross-over design. Test meals included breakfast, lunch, snack and dinner. Glycaemic response was measured continuously for over 24 h and postprandial substrate oxidation for 10 h inside a whole body calorimeter. The low GI diet resulted in lower 24 h glucose iAUC (860 ± 440 vs 1329 ± 614 mmol/L.min; p = 0.014) with lower postprandial glucose iAUC after breakfast (p low GI vs high GI diet (1.44 ± 0.63 vs 2.33 ± 0.82 mmol/L; p fat oxidation was less during the low vs high GI diet (-0.033 ± 0.021 vs -0.050 ± 0.017 g/min; p low GI local foods to construct a 24 h low GI diet, is able to reduce glycaemic response and variability as recorded by continuous glucose monitoring. Our observations also confirm that a low GI diet promotes fat oxidation over carbohydrate oxidation when compared to a high GI diet. These observations provide public health support for the encouragement of healthier nutrition choices by consuming low GI foods. NCT 02631083 (Clinicaltrials.gov).

  5. 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

  6. 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

    Science.gov (United States)

    Eriksson, Andreas C; Jonasson, Lena; Lindahl, Tomas L; Hedbäck, Bo; Whiss, Per A

    2009-01-01

    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-induced activation measured by flow

  7. 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

  8. 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.

  9. Reporting on blinding in trial protocols and corresponding publications was often inadequate but rarely contradictory

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Pildal, Julie; Chan, An-Wen

    2009-01-01

    OBJECTIVE: To compare the reporting on blinding in protocols and articles describing randomized controlled trials. STUDY DESIGN AND SETTING: We studied 73 protocols of trials approved by the scientific/ethical committees for Copenhagen and Frederiksberg, 1994 and 1995, and their corresponding...... publications. RESULTS: Three out of 73 trials (4%) reported blinding in the protocol that contradicted that in the publication (e.g., "open" vs. "double blind"). The proportion of "double-blind" trials with a clear description of the blinding of participants increased from 11 out of 58 (19%) when based...... on publications alone to 39 (67%) when adding the information in the protocol. The similar proportions for the blinding of health care providers were 2 (3%) and 22 (38%); and for the blinding of data collectors, they were 8 (14%) and 14 (24%). In 52 of 58 publications (90%), it was unclear whether all patients...

  10. RAPP, a systematic e-assessment of postoperative recovery in patients undergoing day surgery: study protocol for a mixed-methods study design including a multicentre, two-group, parallel, single-blind randomised controlled trial and qualitative interview studies.

    Science.gov (United States)

    Nilsson, U; Jaensson, M; Dahlberg, K; Odencrants, S; Grönlund, Å; Hagberg, L; Eriksson, M

    2016-01-13

    Day surgery is a well-established practice in many European countries, but only limited information is available regarding postoperative recovery at home though there is a current lack of a standard procedure regarding postoperative follow-up. Furthermore, there is also a need for improvement of modern technology in assessing patient-related outcomes such as mobile applications. This article describes the Recovery Assessment by Phone Points (RAPP) study protocol, a mixed-methods study to evaluate if a systematic e-assessment follow-up in patients undergoing day surgery is cost-effective and improves postoperative recovery, health and quality of life. This study has a mixed-methods study design that includes a multicentre, two-group, parallel, single-blind randomised controlled trial and qualitative interview studies. 1000 patients >17 years of age who are undergoing day surgery will be randomly assigned to either e-assessed postoperative recovery follow-up daily in 14 days measured via smartphone app including the Swedish web-version of Quality of Recovery (SwQoR) or to standard care (ie, no follow-up). The primary aim is cost-effectiveness. Secondary aims are (A) to explore whether a systematic e-assessment follow-up after day surgery has a positive effect on postoperative recovery, health-related quality of life (QoL) and overall health; (B) to determine whether differences in postoperative recovery have an association with patient characteristic, type of surgery and anaesthesia; (C) to determine whether differences in health literacy have a substantial and distinct effect on postoperative recovery, health and QoL; and (D) to describe day surgery patient and staff experiences with a systematic e-assessment follow-up after day surgery.The primary aim will be measured at 2 weeks postoperatively and secondary outcomes (A-C) at 1 and 2 weeks and (D) at 1 and 4 months. NCT02492191; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use

  11. 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.

  12. 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

  13. The Effect of Botulinum Toxin A Injections in the Spine Muscles for Cerebral Palsy Scoliosis, Examined in a Prospective, Randomized Triple-blinded Study.

    Science.gov (United States)

    Wong, Christian; Pedersen, Søren Anker; Kristensen, Billy B; Gosvig, Kasper; Sonne-Holm, Stig

    2015-12-01

    A prospective, randomized triple-blinded cross-over design treating with either botulinum toxin A (BXT) or saline (NaCl). To examine the efficacy of BTX treatment in cerebral palsy scoliosis (CPS). Intramuscular injections with BTX have been used off label in treating CPS. 1 prospective study has been conducted, demonstrating in both radiological and clinical improvement, whereas showing no side effects or complications. Subjects (brace-treated CPS between 2 and 18 yr) were injected using ultrasonic-guidance with either NaCl or BTX in selected spine muscles with 6 mo intervals (block randomization, sealed envelope). Radiographs of the spine and clinical follow-up were captured before and 6 weeks after each injection. Primary outcome parameter was radiological change in Cobb angle, where a 7° change was regarded as an effect (1 SD). Radiological parameters were measured before and 6 weeks after treatment by 3 experienced doctors separately. Moreover, clinical results were evaluated by the pediatric quality of life score and systematic open questioning of the parents about the child's wellbeing. Subjects, researchers, and monitors were blinded during the trial. Appropriate permissions (2008-004584-19) and no funding were obtained. 16 cerebral palsy patients (GFMCS III-V) with CPS were consecutively included, whereas 6 patients were excluded. There were no drop-outs to follow-up, but 1 possible serious adverse event of pneumonia resulting in death was recorded and the study was terminated. No significant radiological or clinical changes were detected when compared with NaCl injections using Wilcoxon matched pair signed-rank test. No positive radiological or clinical effects were demonstrated by this treatment, except for the parent's initial subjective but positive appraisal of the effect. However, the study was terminated due to 1 possible severe adverse event and scheduled numbers needed to treat (hence power) were not reached. 1.

  14. 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.

  15. 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.

  16. What makes an automated teller machine usable by blind users?

    Science.gov (United States)

    Manzke, J M; Egan, D H; Felix, D; Krueger, H

    1998-07-01

    Fifteen blind and sighted subjects, who featured as a control group for acceptance, were asked for their requirements for automated teller machines (ATMs). Both groups also tested the usability of a partially operational ATM mock-up. This machine was based on an existing cash dispenser, providing natural speech output, different function menus and different key arrangements. Performance and subjective evaluation data of blind and sighted subjects were collected. All blind subjects were able to operate the ATM successfully. The implemented speech output was the main usability factor for them. The different interface designs did not significantly affect performance and subjective evaluation. Nevertheless, design recommendations can be derived from the requirement assessment. The sighted subjects were rather open for design modifications, especially the implementation of speech output. However, there was also a mismatch of the requirements of the two subject groups, mainly concerning the key arrangement.

  17. Overview on Deaf-Blindness

    Science.gov (United States)

    ... of Deaf-Blind Education Transition to Adulthood > Transition Self Determination Person Centered Planning Postsecondary Education Independent Living Employment Customized Employment Sex Education Adult Services Technology Personnel > Intervener Services Support ...

  18. American Foundation for the Blind

    Science.gov (United States)

    ... loss Text Size Smaller Type Larger Type Change Colors My AFB Search Donate to AFB Shop AFB ... and More Public Policy and Research Statistics on Blindness DirectConnect: Public Policy and Advocacy News Research Navigator: ...

  19. 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.

  20. Individual differences in change blindness

    OpenAIRE

    Bergmann, Katharina Verena

    2016-01-01

    The present work shows the existence of systematic individual differences in change blindness. It can be concluded that the sensitivity for changes is a trait. That is, persons differ in their ability to detect changes, independent from the situation or the measurement method. Moreover, there are two explanations for individual differences in change blindness: a) capacity differences in visual selective attention that may be influenced by top-down activated attention helping to focus attentio...

  1. 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 ...

  2. Blinded trials taken to the test

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Forfang, E; Haahr, M T

    2007-01-01

    Blinding can reduce bias in randomized clinical trials, but blinding procedures may be unsuccessful. Our aim was to assess how often randomized clinical trials test the success of blinding, the methods involved and how often blinding is reported as being successful....

  3. 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....

  4. 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 ...

  5. 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.

  6. 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.

    Science.gov (United States)

    Nilsson, Anne; Johansson, Elin; Ekström, Linda; Björck, Inger

    2013-01-01

    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. 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. An evening meal of brown beans, in comparison with WWB, lowered blood glucose (-15%, prisk 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 beans may provide a preventive tool in relation to obesity and the metabolic syndrome. ClinicalTrials.gov NCT01706042.

  7. Enhanced bioavailability of lycopene when consumed as cis-isomers from tangerine compared to red tomato juice, a randomized, cross-over clinical trial

    Science.gov (United States)

    Cooperstone, Jessica L.; Ralston, Robin A.; Riedl, Ken M.; Haufe, Thomas C.; Schweiggert, Ralf M.; King, Samantha A.; Timmers, Cynthia D.; Francis, David M.; Lesinski, Gregory B.; Clinton, Steven K.; Schwartz, Steven J.

    2015-01-01

    Scope Tangerine tomatoes (Solanum lycopersicum) are rich in tetra-cis-lycopene resulting from natural variation in carotenoid isomerase. Our objective was to compare the bioavailability of lycopene from tangerine to red tomato juice, and elucidate physical deposition forms of these isomers in tomatoes by light and electron microscopy. Methods and results Following a randomized crossover design, subjects (n=11, 6M/5F) consumed two meals delivering 10 mg lycopene from tangerine (94% cis) or red tomato juice (10% cis). Blood was sampled over 12 hours and triglyceride-rich lipoprotein fractions of plasma (TRLs) were isolated and analyzed using HPLC-DAD-MS/MS. Lycopene was crystalline in red tomato chromoplasts and globular in tangerine tomatoes. With tangerine tomato juice we observed a marked 8.5-fold increase in lycopene bioavailability compared to red tomato juice (PLycopene is markedly more bioavailable from tangerine than from red tomato juice, consistent with a predominance of cis-lycopene isomers and presence in chromoplasts in a lipid dissolved globular state. These results justify using tangerine tomatoes as a lycopene source in studies examining the potential health benefits of lycopene-rich foods. PMID:25620547

  8. 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.

  9. [Aiming for zero blindness].

    Science.gov (United States)

    Nakazawa, Toru

    2015-03-01

    Glaucoma is the leading cause of acquired blindness in Japan. One reason that it often leads to blindness is that it can continue to worsen even after effective medical reduction of intraocular pressure (IOP), the only evidence-based treatment. The limitations of current treatments make it critical to identify IOP-independent factors that can cause glaucoma and develop new drugs to target these factors. This is a challenging task, as the pathology of glaucoma is thought to be very complex, with different combinations of factors underlying its development and progression in different patients. Additionally, there is a deficiency in methods to efficiently perform clinical evaluations and reliably probe the state of the disease over relatively short periods. In addition, newly developed drugs need to be evaluated with clinical trials, for which human and financial resources are limited, before they can be widely used for treatment. Taking all these issues into consideration, it is evident that there are two urgent issues to consider: the development of methods to classify glaucoma in detail based on its pathology, and the improvement of clinical evaluation methods. In this review, we discuss some of our efforts to develop new neuroprotective agents for glaucoma, with a focus on the following three areas: 1. Clinical research and development of methods to classify glaucoma in detail based on IOP-independent factors, and the exploration of possibilities for the improvement of clinical evaluation of glaucoma. 2. Pathology-based research and development of new drugs for glaucoma, focusing on comprehensive gene expression analysis and the development of molecule-targeting drugs, using murine optic nerve crush as a disease model. 3. Development of next generation in vivo imaging modalities and the establishment of infrastructure enabling "big-data" analysis. First, we discuss our clinical research and the development of methods to classify glaucoma in detail based on IOP

  10. 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

  11. 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

  12. 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…

  13. Teacher Training Workshop for Educators of Students Who Are Blind or Low Vision

    Science.gov (United States)

    Supalo, Cary A.; Dwyer, Danielle; Eberhart, Heather L.; Bunnag, Natasha; Mallouk, Thomas E.

    2009-01-01

    The Independent Laboratory Access for the Blind (ILAB) project has developed a suite of speech accessible tools for students who are blind or low vision to use in secondary and postsecondary science laboratory classes. The following are illustrations of experiments designed to be used by educators to introduce them to the ILAB tools, and to…

  14. 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…

  15. 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…

  16. 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...

  17. 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.

  18. New treatments of hereditary blindness

    DEFF Research Database (Denmark)

    Bertelsen, Mette; Rosenberg, Thomas; Larsen, Michael

    2013-01-01

    Ongoing clinical trials are targeting several previously intractable hereditary causes of blindness of congenital, childhood or early adulthood onset, mainly in the optic nerve and retina. The intended stage of initiation of the new therapeutic approaches ranges from neonatal life and a structura......Ongoing clinical trials are targeting several previously intractable hereditary causes of blindness of congenital, childhood or early adulthood onset, mainly in the optic nerve and retina. The intended stage of initiation of the new therapeutic approaches ranges from neonatal life...... and a structurally intact retinal tissue to adult life with a complete loss of photoreceptors. It must be assumed that some of the trials will succeed in producing new therapies and action must be taken to refine and accelerate diagnostics and to preserve therapeutic potential in blind people....

  19. Working memory and inattentional blindness.

    Science.gov (United States)

    Bredemeier, Keith; Simons, Daniel J

    2012-04-01

    Individual differences in working memory predict many aspects of cognitive performance, especially for tasks that demand focused attention. One negative consequence of focused attention is inattentional blindness, the failure to notice unexpected objects when attention is engaged elsewhere. Yet, the relationship between individual differences in working memory and inattentional blindness is unclear; some studies have found that higher working memory capacity is associated with greater noticing, but others have found no direct association. Given the theoretical and practical significance of such individual differences, more definitive tests are needed. In two studies with large samples, we tested the relationship between multiple working memory measures and inattentional blindness. Individual differences in working memory predicted the ability to perform an attention-demanding tracking task, but did not predict the likelihood of noticing an unexpected object present during the task. We discuss the reasons why we might not expect such individual differences in noticing and why other studies may have found them.

  20. 20 CFR 416.983 - How we evaluate statutory blindness.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false How we evaluate statutory blindness. 416.983... AGED, BLIND, AND DISABLED Determining Disability and Blindness Blindness § 416.983 How we evaluate statutory blindness. We will find that you are blind if you are statutorily blind within the meaning of...

  1. 20 CFR 416.982 - Blindness under a State plan.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Blindness under a State plan. 416.982 Section..., BLIND, AND DISABLED Determining Disability and Blindness Blindness § 416.982 Blindness under a State... plan because of your blindness for the month of December 1973; and (c) You continue to be blind as...

  2. 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.

  3. 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.

  4. 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.

  5. Three-Dimensional Models for Teaching Neuroanatomy to Blind Students.

    Science.gov (United States)

    Pietsch, Paul

    1980-01-01

    An audio/tactile course enables blind college students to understand the anatomy of the human brain. Models were designed which allow tactile exploration of the visual fields, retina, optic nerves, and the subdivisions of the tracts and radiations in the brain. (Author/PHR)

  6. 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.

  7. Blind Naso-Endotracheal Intubation

    African Journals Online (AJOL)

    Difficult endotracheal intubation techniques include, use of fiberoptic bronchoscope, intubating laryngeal mask airway, tracheostomy, blind nasotracheal and retrograde intubation. According to the Difficult Airway Society guidelines, intubating with the aid of a fiberoptic scope has taken its place as the standard adjuvant for.

  8. Metro Navigation for the Blind

    Science.gov (United States)

    Sanchez, Jaime; Saenz, Mauricio

    2010-01-01

    This study evaluates the impact of using the software program AudioMetro, a tool that supports the orientation and mobility of people who are blind in the Metro system of Santiago de Chile. A quasi-experimental study considering experimental and control groups and using the paired Student's t in a two sample test analysis (pretest-posttest) was…

  9. Vesicouterine fistula and blind vagina

    International Nuclear Information System (INIS)

    Hafeez, M.; Hameed, S.; Asif, S.

    2003-01-01

    A case of vesicouterine fistula with blind vagina following cesarean section for obstructed labor is presented. It was surgically treated by fistulectomy, cervicoplasty and maintenance of bladder and cervical potency by catheterization. Intrauterine synechiae formation was prevented by copper T insertion and oral contraceptive pills. The patient is making uneventful a symptomatic progress planning to conceive. (author)

  10. Ask a Scientist: What is Color Blindness?

    Medline Plus

    Full Text Available ... the special health problems and requirements of the blind.” News & Events Events Calendar NEI Press Releases News ... series. Dr. Sheldon Miller answers questions about color blindness, whether it can be treated, and how people ...

  11. Ask a Scientist: What is Color Blindness?

    Medline Plus

    Full Text Available ... series. Dr. Sheldon Miller answers questions about color blindness, whether it can be treated, and how people ... optical illusion? Click to Watch What is color blindness? Click to Watch How do I become a ...

  12. Ask a Scientist: What is Color Blindness?

    Medline Plus

    Full Text Available ... video series. Dr. Sheldon Miller answers questions about color blindness, whether it can be treated, and how people ... an optical illusion? Click to Watch What is color blindness? Click to Watch How do I become a ...

  13. Ask a Scientist: What is Color Blindness?

    Science.gov (United States)

    ... video series. Dr. Sheldon Miller answers questions about color blindness, whether it can be treated, and how people ... an optical illusion? Click to Watch What is color blindness? Click to Watch How do I become a ...

  14. Ask a Scientist: What is Color Blindness?

    Medline Plus

    Full Text Available ... to blinding eye diseases, visual disorders, mechanisms of visual function, preservation of sight, and the special health problems and requirements of the blind.” ... Clinical Studies Publications Catalog Photos ...

  15. Blinding in randomized clinical trials: imposed impartiality

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Boutron, I

    2011-01-01

    Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations...

  16. Ask a Scientist: What is Color Blindness?

    Medline Plus

    Full Text Available ... Illusions Printables Ask a Scientist Video Series Why can’t you see colors well in the dark? ... Miller answers questions about color blindness, whether it can be treated, and how people become color blind. ...

  17. On imitation among young and blind children

    Directory of Open Access Journals (Sweden)

    Maria Rita Campello Rodrigues

    2016-07-01

    Full Text Available This article investigates the imitation among young and blind children. The survey was conducted as a mosaic in the time since the field considerations were taken from two areas: a professional experience with early stimulation of blind babies and a workshop with blind and low vision young between 13-18 years. By statingthe situated trace of knowledge, theresearch indicates that imitation among blind young people can be one of the ways of creating a common world among young blind and sighted people. Imitation among blind young is a multi-sensory process that requires a body experience, including both blind and people who see. The paper concludes with an indication of the unique character of imitation and at the same time, with the affirmation of its relevance to the development and inclusion process of both the child and the young blind.

  18. 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....

  19. 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

  20. Prefrontal transcranial direct current stimulation (tDCS) as treatment for major depression: study design and methodology of a multicenter triple blind randomized placebo controlled trial (DepressionDC).

    Science.gov (United States)

    Padberg, Frank; Kumpf, Ulrike; Mansmann, Ulrich; Palm, Ulrich; Plewnia, Christian; Langguth, Berthold; Zwanzger, Peter; Fallgatter, Andreas; Nolden, Jana; Burger, Max; Keeser, Daniel; Rupprecht, Rainer; Falkai, Peter; Hasan, Alkomiet; Egert, Silvia; Bajbouj, Malek

    2017-12-01

    Transcranial direct current stimulation (tDCS) has been proposed as novel treatment for major depressive disorder (MDD) based on clinical pilot studies as well as randomized controlled monocentric trials. The DepressionDC trial is a triple-blind (blinding of rater, operator and patient), randomized, placebo controlled multicenter trial investigating the efficacy and safety of prefrontal tDCS used as additive treatment in MDD patients who have not responded to selective serotonin reuptake inhibitors (SSRI). At 5 study sites, 152 patients with MDD receive a 6-weeks treatment with active tDCS (anode F3 and cathode F4, 2 mA intensity, 30 min/day) or sham tDCS add-on to a stable antidepressant medication with an SSRI. Follow-up visits are at 3 and 6 months after the last tDCS session. The primary outcome measure is the change of the Montgomery-Asberg Depression Rating Scale (MADRS) scores at week 6 post-randomisation compared to baseline. Secondary endpoints also cover other psychopathological domains, and a comprehensive safety assessment includes measures of cognition. Patients undergo optional investigations comprising genetic testing and functional magnetic resonance imaging (fMRI) of structural and functional connectivity. The study uses also an advanced tDCS technology including standard electrode positioning and recording of technical parameters (current, impedance, voltage) in every tDCS session. Aside reporting the study protocol here, we present a novel approach for monitoring technical parameters of tDCS which will allow quality control of stimulation and further analysis of the interaction between technical parameters and clinical outcome. The DepressionDC trial will hopefully answer the important clinical question whether prefrontal tDCS is a safe and effective antidepressant intervention in patients who have not sufficiently responded to SSRIs. ClinicalTrials.gov Identifier NCT0253016.

  1. "VisionTouch Phone" for the Blind.

    Science.gov (United States)

    Yong, Robest

    2013-10-01

    Our objective is to enable the blind to use smartphones with touchscreens to make calls and to send text messages (sms) with ease, speed, and accuracy. We believe that with our proposed platform, which enables the blind to locate the position of the keypads, new games and education, and safety applications will be increasingly developed for the blind. This innovative idea can also be implemented on tablets for the blind, allowing them to use information websites such as Wikipedia and newspaper portals.

  2. 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…

  3. Evaluation of the attentional capacities and working memory of early and late blind persons.

    Science.gov (United States)

    Pigeon, Caroline; Marin-Lamellet, Claude

    2015-02-01

    Although attentional processes and working memory seem to be significantly involved in the daily activities (particularly during navigating) of persons who are blind and who use these abilities to compensate for their lack of vision, few studies have investigated these mechanisms in this population. The aim of this study is to evaluate the selective, sustained and divided attention, attentional inhibition and switching and working memory of blind persons. Early blind, late blind and sighted participants completed neuropsychological tests that were designed or adapted to be achievable in the absence of vision. The results revealed that the early blind participants outperformed the sighted ones in selective, sustained and divided attention and working memory tests, and the late blind participants outperformed the sighted participants in selective, sustained and divided attention. However, no differences were found between the blind groups and the sighted group in the attentional inhibition and switching tests. Furthermore, no differences were found between the early and late blind participants in this set of tests. These results suggest that early and late blind persons can compensate for the lack of vision by an enhancement of the attentional and working memory capacities. Copyright © 2014 Elsevier B.V. All rights reserved.

  4. What It's Like to Be Color Blind

    Science.gov (United States)

    ... a green leaf might look tan or gray. Color Blindness Is Passed Down Color blindness is almost always an inherited (say: in-HER- ... Eye doctors (and some school nurses) test for color blindness by showing a picture made up of different ...

  5. Occupant satisfaction with two blind control strategies

    DEFF Research Database (Denmark)

    Karlsen, Line Røseth; Heiselberg, Per Kvols; Bryn, Ida

    2015-01-01

    Highlights •Occupant satisfaction with two blind control strategies has been studied. •Control based on cut-off position of slats was more popular than closed slats. •Results from the study are helpful in development of control strategies for blinds. •The results give indications of how blinds...

  6. Mobility aid for blind figure skaters

    International Nuclear Information System (INIS)

    Acerbi, A; Graffigna, J P; Polimeni, G; Fernandez, H H

    2007-01-01

    This work is developed within the scope of rehabilitation technology to enable blind and visually impaired persons read non-Braille material commonly available in digital form to normal-vision readers. This approach, therefore, tries to broaden the reaching capacity for these persons and, thus, allow for better inclusion in social, work, educative and even leisure activities. Specifically, it is devised for reading any kind of text in digital form --books, files, documents, Internet information and exchanges, etc.-- that can be loaded in a PC to be later read on the devised Braille reading line. It consists of a string-like platform of electrodes that simulate, through tactile electrostimulation, the letter characters displayed in Braille fashion. Finger-tip feeling from these electric discharges is caused by stimulating the skin nerve receptors underneath the tip. These electric discharges produce a similar effect as when reading embossed-type characters of traditional Braille-relief paper material. After design and development, experiences were made with blind persons, with fairly satisfactory results. At present, further work is under way in order to improve the system

  7. Mobility aid for blind figure skaters

    Energy Technology Data Exchange (ETDEWEB)

    Acerbi, A; Graffigna, J P; Polimeni, G; Fernandez, H H [Gabinete de Tecnologia Medica, Fac. de Ingenieria, Universidad Nac. de San Juan Av Libertador San Martin 1109(O), J5400ARL, San Juan (Argentina)

    2007-11-15

    This work is developed within the scope of rehabilitation technology to enable blind and visually impaired persons read non-Braille material commonly available in digital form to normal-vision readers. This approach, therefore, tries to broaden the reaching capacity for these persons and, thus, allow for better inclusion in social, work, educative and even leisure activities. Specifically, it is devised for reading any kind of text in digital form --books, files, documents, Internet information and exchanges, etc.-- that can be loaded in a PC to be later read on the devised Braille reading line. It consists of a string-like platform of electrodes that simulate, through tactile electrostimulation, the letter characters displayed in Braille fashion. Finger-tip feeling from these electric discharges is caused by stimulating the skin nerve receptors underneath the tip. These electric discharges produce a similar effect as when reading embossed-type characters of traditional Braille-relief paper material. After design and development, experiences were made with blind persons, with fairly satisfactory results. At present, further work is under way in order to improve the system.

  8. Mobility aid for blind figure skaters

    Science.gov (United States)

    Acerbi, A.; Graffigna, J. P.; Polimeni, G.; Fernández, H. H.

    2007-11-01

    This work is developed within the scope of rehabilitation technology to enable blind and visually impaired persons read non-Braille material commonly available in digital form to normal-vision readers. This approach, therefore, tries to broaden the reaching capacity for these persons and, thus, allow for better inclusion in social, work, educative and even leisure activities. Specifically, it is devised for reading any kind of text in digital form --books, files, documents, Internet information and exchanges, etc.-- that can be loaded in a PC to be later read on the devised Braille reading line. It consists of a string-like platform of electrodes that simulate, through tactile electrostimulation, the letter characters displayed in Braille fashion. Finger-tip feeling from these electric discharges is caused by stimulating the skin nerve receptors underneath the tip. These electric discharges produce a similar effect as when reading embossed-type characters of traditional Braille-relief paper material. After design and development, experiences were made with blind persons, with fairly satisfactory results. At present, further work is under way in order to improve the system.

  9. Blind prediction of natural video quality.

    Science.gov (United States)

    Saad, Michele A; Bovik, Alan C; Charrier, Christophe

    2014-03-01

    We propose a blind (no reference or NR) video quality evaluation model that is nondistortion specific. The approach relies on a spatio-temporal model of video scenes in the discrete cosine transform domain, and on a model that characterizes the type of motion occurring in the scenes, to predict video quality. We use the models to define video statistics and perceptual features that are the basis of a video quality assessment (VQA) algorithm that does not require the presence of a pristine video to compare against in order to predict a perceptual quality score. The contributions of this paper are threefold. 1) We propose a spatio-temporal natural scene statistics (NSS) model for videos. 2) We propose a motion model that quantifies motion coherency in video scenes. 3) We show that the proposed NSS and motion coherency models are appropriate for quality assessment of videos, and we utilize them to design a blind VQA algorithm that correlates highly with human judgments of quality. The proposed algorithm, called video BLIINDS, is tested on the LIVE VQA database and on the EPFL-PoliMi video database and shown to perform close to the level of top performing reduced and full reference VQA algorithms.

  10. 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

    Higher-protein meals decrease hunger and increase satiety compared to lower-protein meals. However, no consensus exists about the different effects of animal and vegetable proteins on appetite. We investigated how a meal based on vegetable protein (fava beans/split peas) affected ad libitum energy......-balanced, fiber-matched meals based on vegetable protein (fava beans/split peas) or animal protein (veal/pork or eggs) had similar effects on ad libitum energy intake and appetite sensations....... 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...

  11. 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...... than reading speed. There was no effect on overall math performance or outcomes from the LRS. In conclusion, school meals did not affect CP, but improved reading performance, which is a complex cognitive activity that involves inference, and increased errors related to impulsivity and inattention...

  12. 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 with 252 Cf neutrons or 137 Cs γ-rays, and male adult flies were examined under the microscope for the presence of the two types of clonal mosaic spots appearing. The induction of wing-hair spots per dose unit was much greater for 252 Cf neutrons than for 137 Cs γ -rays, whereas the frequencies of eye-color reversion were similar for neutrons and γ-rays. The estimated RBE values of neutrons were 8.5 and 1.2 for the induction of mutant wing-hair spots and revertant eye-color spots, respectively. These results indicate that the RBE of neutrons is much greater for mitotic crossing over in comparison to the intragenic white-ivory reversion events. Possible causes for the difference in RBE are discussed

  13. An alternative approach to treating lateral epicondylitis. A randomized, placebo-controlled, double-blinded study

    NARCIS (Netherlands)

    Nourbakhsh, Mohammad Reza; Fearon, Frank J.

    Objective: To investigate the effect of noxious level electrical stimulation on pain, grip strength and functional abilities in subjects with chronic lateral epicondylitis. Design: Randomized, placebo-control, double-blinded study. Setting: Physical Therapy Department, North Georgia College and

  14. Electronic white cane with GPS radar-based concept as blind mobility enhancement without distance limitation

    Science.gov (United States)

    Halim, Suharsono; Handafiah, Finna; Aprilliyani, Ria; Udhiarto, Arief

    2018-02-01

    The Indonesian Ministry of Social Affairs, in July 2012, informed that the number of blind in Indonesia has been the largest among to the people with other disabilities. The most common tools utilized to help the blind was a conventional cane which has limited features and therefore it was difficult to be used as a mobilization tools. Moreover, the conventional cane cannot assist them or their family when the blind gets lost. In this research, we designed and implemented an electronic white cane with the concept of radar and global positioning system (GPS). The purpose of this research was to design and develop an electronic white cane which can enhance the mobility of the blind without distance coverage limitation. Utilizing ultrasonic sensors as a distance measurement and a servo motor as an actuator, the produced radar system is able to map an area with maximum distance and coverage angle of 5 meters and 180° respectively. The blind senses the obstacle around them from the vibration generated by five vibration motors. The vibration becomes more intense when the obstacle is detected closer. In addition, we implemented a GPS to monitor the blind's position and allow their family to find them easily when the blind need a help. Based on the tests performed, we have successfully developed an electronic white cane that can be a solution to improve the blind's mobility.

  15. Replacement of glycaemic carbohydrates by inulin-type fructans from chicory (oligofructose, inulin) reduces the postprandial blood glucose and insulin response to foods: report of two double-blind, randomized, controlled trials.

    Science.gov (United States)

    Lightowler, Helen; Thondre, Sangeetha; Holz, Anja; Theis, Stephan

    2018-04-01

    Inulin-type fructans are recognized as prebiotic dietary fibres and classified as non-digestible carbohydrates that do not contribute to glycaemia. The aim of the present studies was to investigate the glycaemic response (GR) and insulinaemic response (IR) to foods in which sucrose was partially replaced by inulin or oligofructose from chicory. In a double-blind, randomized, controlled cross-over design, 40-42 healthy adults consumed a yogurt drink containing oligofructose or fruit jelly containing inulin and the respective full-sugar variants. Capillary blood glucose and insulin were measured in fasted participants and at 15, 30, 45, 60, 90, and 120 min after starting to drink/eat. For each test food, the incremental area under the curve (iAUC) for glucose and insulin was calculated and the GR and IR determined. Consumption of a yogurt drink with oligofructose which was 20% reduced in sugars significantly lowered the glycaemic response compared to the full-sugar reference (iAUC 120min 31.9 and 37.3 mmol/L/min, respectively; p inulin and containing 30% less sugars than the full-sugar variant likewise resulted in a significantly reduced blood glucose response (iAUC 120min 53.7 and 63.7 mmol/L/min, respectively; p inulin-type fructans (p inulin or oligofructose from chicory may be an effective strategy to reduce the postprandial blood glucose response to foods.

  16. Rapid Assessment of Avoidable Blindness in Western Rwanda: Blindness in a Postconflict Setting

    OpenAIRE

    Mathenge, Wanjiku; Nkurikiye, John; Limburg, Hans; Kuper, Hannah

    2007-01-01

    Editors' Summary Background. VISION 2020, a global initiative that aims to eliminate avoidable blindness, has estimated that 75% of blindness worldwide is treatable or preventable. The WHO estimates that in Africa, around 9% of adults aged over 50 are blind. Some data suggest that people living in regions affected by violent conflict are more likely to be blind than those living in unaffected regions. Currently no data exist on the likely prevalence of blindness in Rwanda, a central African c...

  17. Contact Lenses for Color Blindness.

    Science.gov (United States)

    Badawy, Abdel-Rahman; Hassan, Muhammad Umair; Elsherif, Mohamed; Ahmed, Zubair; Yetisen, Ali K; Butt, Haider

    2018-06-01

    Color vision deficiency (color blindness) is an inherited genetic ocular disorder. While no cure for this disorder currently exists, several methods can be used to increase the color perception of those affected. One such method is the use of color filtering glasses which are based on Bragg filters. While these glasses are effective, they are high cost, bulky, and incompatible with other vision correction eyeglasses. In this work, a rhodamine derivative is incorporated in commercial contact lenses to filter out the specific wavelength bands (≈545-575 nm) to correct color vision blindness. The biocompatibility assessment of the dyed contact lenses in human corneal fibroblasts and human corneal epithelial cells shows no toxicity and cell viability remains at 99% after 72 h. This study demonstrates the potential of the dyed contact lenses in wavelength filtering and color vision deficiency management. © 2018 The Authors. Published by WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  18. Demonstration of blind quantum computing.

    Science.gov (United States)

    Barz, Stefanie; Kashefi, Elham; Broadbent, Anne; Fitzsimons, Joseph F; Zeilinger, Anton; Walther, Philip

    2012-01-20

    Quantum computers, besides offering substantial computational speedups, are also expected to preserve the privacy of a computation. We present an experimental demonstration of blind quantum computing in which the input, computation, and output all remain unknown to the computer. We exploit the conceptual framework of measurement-based quantum computation that enables a client to delegate a computation to a quantum server. Various blind delegated computations, including one- and two-qubit gates and the Deutsch and Grover quantum algorithms, are demonstrated. The client only needs to be able to prepare and transmit individual photonic qubits. Our demonstration is crucial for unconditionally secure quantum cloud computing and might become a key ingredient for real-life applications, especially when considering the challenges of making powerful quantum computers widely available.

  19. Blind Deconvolution With Model Discrepancies

    Czech Academy of Sciences Publication Activity Database

    Kotera, Jan; Šmídl, Václav; Šroubek, Filip

    2017-01-01

    Roč. 26, č. 5 (2017), s. 2533-2544 ISSN 1057-7149 R&D Projects: GA ČR GA13-29225S; GA ČR GA15-16928S Institutional support: RVO:67985556 Keywords : blind deconvolution * variational Bayes * automatic relevance determination Subject RIV: JD - Computer Applications, Robotics OBOR OECD: Computer hardware and architecture Impact factor: 4.828, year: 2016 http://library.utia.cas.cz/separaty/2017/ZOI/kotera-0474858.pdf

  20. Multichannel blind iterative image restoration

    Czech Academy of Sciences Publication Activity Database

    Šroubek, Filip; Flusser, Jan

    2003-01-01

    Roč. 12, č. 9 (2003), s. 1094-1106 ISSN 1057-7149 R&D Projects: GA ČR GA102/00/1711 Institutional research plan: CEZ:AV0Z1075907 Keywords : conjugate gradient * half-quadratic regularization * multichannel blind deconvolution Subject RIV: BD - Theory of Information Impact factor: 2.642, year: 2003 http://library.utia.cas.cz/prace/20030104.pdf

  1. Repetitive Transcranial Magnetic Stimulation Improved Symptoms of Obsessive-Compulsive Disorder, but Also Cognitive Performance: Results from a Randomized Clinical Trial with a Cross-Over Design and Sham Condition.

    Science.gov (United States)

    Jahangard, Leila; Haghighi, Mohammad; Shyayganfard, Mehran; Ahmadpanah, Mohammad; Sadeghi Bahmani, Dena; Bajoghli, Hafez; Holsboer-Trachsler, Edith; Brand, Serge

    2016-01-01

    There is some evidence that repetitive transcranial magnetic stimulation (rTMS) is an effective method of treating patients suffering from obsessive-compulsive disorder (OCD). Here, we tested the hypothesis that rTMS has a positive impact both on symptom severity and cognitive performance in such patients. Specifically, short-term verbal processing speed and flexibility were assessed. Ten patients suffering from refractory OCD and treated with standard medication were randomly assigned either to a treatment-first or to a sham-first condition. At baseline and after 2 and 4 weeks, symptom severity (experts' ratings) and cognitive performance (auditory perception, visual perception, short-term memory, and processing speed) were assessed. After 2 weeks, the treatment condition switched to the sham condition, and the sham condition switched to the treatment condition. Under treatment but not under sham conditions, symptom severity reduced. Moreover, cognitive performance improved in parallel. rTMS is a safe and efficient treatment for patients suffering from refractory OCD; symptoms and cognitive performance improved in parallel. © 2016 S. Karger AG, Basel.

  2. Justifications shape ethical blind spots.

    Science.gov (United States)

    Pittarello, Andrea; Leib, Margarita; Gordon-Hecker, Tom; Shalvi, Shaul

    2015-06-01

    To some extent, unethical behavior results from people's limited attention to ethical considerations, which results in an ethical blind spot. Here, we focus on the role of ambiguity in shaping people's ethical blind spots, which in turn lead to their ethical failures. We suggest that in ambiguous settings, individuals' attention shifts toward tempting information, which determines the magnitude of their lies. Employing a novel ambiguous-dice paradigm, we asked participants to report the outcome of the die roll appearing closest to the location of a previously presented fixation cross on a computer screen; this outcome would determine their pay. We varied the value of the die second closest to the fixation cross to be either higher (i.e., tempting) or lower (i.e., not tempting) than the die closest to the fixation cross. Results of two experiments revealed that in ambiguous settings, people's incorrect responses were self-serving. Tracking participants' eye movements demonstrated that people's ethical blind spots are shaped by increased attention toward tempting information. © The Author(s) 2015.

  3. Randomized, double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: novel findings using a simulated adult workplace environment design

    Directory of Open Access Journals (Sweden)

    Gao Joseph

    2010-06-01

    Full Text Available Abstract Background Duration of efficacy and safety of lisdexamfetamine dimesylate (LDX was assessed in adults (18-55 years with attention-deficit/hyperactivity disorder (ADHD using the simulated adult workplace environment. Methods After open-label dose optimization (4-week with LDX, 30-70 mg/d, subjects entered a 2-week randomized, double-blind, placebo-controlled crossover phase. Efficacy assessments included the Permanent Product Measure of Performance (PERMP total score (attempted+correct measured predose and from 2 to 14 hours postdose, averaged across postdose sessions (primary and at each time point vs placebo (secondary, and ADHD Rating Scale IV (ADHD-RS-IV with adult prompts at baseline and crossover visits. Safety assessments included treatment-emergent adverse events (TEAEs, vital signs, and electrocardiograms. Results Of 127 randomized subjects, 105 were in the intention-to-treat population and 103 completed the study. While receiving LDX vs placebo, adults had greater improvement (P P ≤ .0017 for each time point and change from predose (P P Conclusions LDX significantly improved PERMP scores vs placebo and maintained improvement throughout the day from the first (2 hours to last (14 hours postdose time point vs placebo in adults with ADHD. Trial Registration ClinicalTrials.gov Identifier: NCT00697515 Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX in Adults With Attention-Deficit Hyperactivity Disorder (ADHD http://www.clinicaltrials.gov/ct2/show/NCT00697515?term=NCT00697515&rank=1

  4. 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...... by providing ideas about future research for investigating mobilities in situ as a kind of “staging,” which he notes is influenced by the “material turn” in social sciences....... 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...

  5. Blindness and Visual Impairment in an Urban West African Population: The Tema Eye Survey

    Science.gov (United States)

    Budenz, Donald L.; Bandi, Jagadeesh R.; Barton, Keith; Nolan, Winifred; Herndon, Leon; Whiteside-de Vos, Julia; Hay-Smith, Graham; Kim, Hanna; Tielsch, James

    2012-01-01

    Objective To determine the prevalence, etiologies, and risk factors of blindness and visual impairment among persons age 40 years and older residing in an urban West African location. Design Population-based cross-sectional study. Participants Five thousand six hundred and three participants residing in Tema, Ghana. Methods Proportionate random cluster sampling was used to select participants age 40 and over living in the city of Tema. Presenting distance visual acuity was measured at 4 and 1 meters using a reduced Logarithm of the Minimum Angle of Resolution (logMAR) tumbling E chart and then with trial frame based on autorefraction. A screening examination was performed in the field on all participants. Complete clinical examination by an ophthalmologist was performed on participants with best corrected visual acuity blindness (visual acuity in the better eye of blindness was 1.2%. After refraction and spectacle correction, the prevalence of visual impairment and blindness decreased to 6.7% and 0.75% respectively, suggesting that refractive error is the major correctable etiology of visual impairment and blindness in this population. Of 65 subjects having visual acuity blindness and visual impairment. Conclusions There is a high prevalence of blindness and visual impairment among those aged ≥40 years in Tema, Ghana, West Africa. Refractive error is a major cause of blindness and visual impairment in this population, followed by cataract, glaucoma, and corneal disease. PMID:22677425

  6. The blind student’s interpretation of two-dimensional shapes in geometry

    Science.gov (United States)

    Andriyani; Budayasa, I. K.; Juniati, D.

    2018-01-01

    The blind student’s interpretation of two-dimensional shapes represents the blind student’s mental image of two-dimensional shapes that they can’t visualize directly, which is related to illustration of the characteristics and number of edges and angles. The objective of this research is to identify the blind student’s interpretation of two-dimensional shapes. This research was an exploratory study with qualitative approach. A subject of this research is a sixth-grade student who experiencing total blind from the fifth grade of elementary school. Researchers interviewed the subject about his interpretation of two-dimensional shapes according to his thinking.The findings of this study show the uniqueness of blind students, who have been totally blind since school age, in knowing and illustrating the characteristics of edges and angles of two-dimensional shapes by utilizing visual experiences that were previously obtained before the blind. The result can inspire teachers to design further learning for development of blind student geometry concepts.

  7. Survey of blindness and low vision in Egbedore, South-Western Nigeria.

    Science.gov (United States)

    Kolawole, O U; Ashaye, A O; Adeoti, C O; Mahmoud, A O

    2010-01-01

    Developing efficient and cost-effective eye care programmes for communities in Nigeria has been hampered by inadequate and inaccurate data on blindness and low vision. To determine the prevalence and causes of blindness and low vision among adults 50 years and older in South-Western Nigeria in order to develop viable eye care programme for the community. Twenty clusters of 60 subjects of age 50 years and older were selected by systematic random cluster sampling. Information was collected and ocular examinations were conducted on each consenting subject. Data were recorded in specially designed questionnaire and analysed using descriptive statistical methods. Out of the 1200 subjects enrolled for the study, 1183(98.6%) were interviewed and examined. Seventy five (6.3%)) of the 1183 subjects were bilaterally blind and 223(18.9%) had bilateral low vision according to WHO definition of blindness and low vision. Blindness was about 1.6 times commoner in men than women. Cataract, glaucoma and posterior segment disorders were major causes of bilateral blindness. Bilateral low vision was mainly due to cataract, refractive errors and posterior segment disorders. The prevalence of blindness and low vision in this study population was high. The main causes are avoidable. Elimination of avoidable blindness and low vision calls for attention and commitment from government and eye care workers in South Western Nigeria.

  8. Blindness

    Science.gov (United States)

    ... NEI Intranet (Employees Only) *PDF files require the free Adobe® Reader® software for viewing. This website is maintained by the NEI Office of Science Communications, Public Liaison, and Education. Technical questions about this website can be addressed ...

  9. Sensory augmentation for the blind

    Directory of Open Access Journals (Sweden)

    Silke Manuela Kärcher

    2012-03-01

    Full Text Available Enacted theories of consciousness conjecture that perception and cognition arise from an active experience of the regular relations that are tying together the sensory stimulation of different modalities and associated motor actions. Previous experiments investigated this concept by employing the technique of sensory substitution. Building on these studies, here we test a set of hypotheses derived from this framework and investigate the utility of sensory augmentation in handicapped people. We provide a late blind subject with a new set of sensorimotor laws: A vibro-tactile belt continually signals the direction of magnetic north. The subject completed a set of behavioral tests before and after an extended training period. The tests were complemented by questionnaires and interviews. This newly supplied information improved performance on different time scales. In a pointing task we demonstrate an instant improvement of performance based on the signal provided by the device. Furthermore, the signal was helpful in relevant daily tasks, often complicated for the blind, such as keeping a direction over longer distances or taking shortcuts in familiar environments. A homing task with an additional attentional load demonstrated a significant improvement after training. The subject found the directional information highly expedient for the adjustment of his inner maps of familiar environments and describes an increase in his feeling of security when exploring unfamiliar environments with the belt. The results give evidence for a firm integration of the newly supplied signals into the behavior of this late blind subject with better navigational performance and more courageous behavior in unfamiliar environments. Most importantly, the complementary information provided by the belt lead to a positive emotional impact with enhanced feeling of security. This experimental approach demonstrates the potential of sensory augmentation devices for the help of

  10. Change blindness, aging, and cognition.

    Science.gov (United States)

    Rizzo, Matthew; Sparks, Jondavid; McEvoy, Sean; Viamonte, Sarah; Kellison, Ida; Vecera, Shaun P

    2009-02-01

    Change blindness (CB), the inability to detect changes in visual scenes, may increase with age and early Alzheimer's disease (AD). To test this hypothesis, participants were asked to localize changes in natural scenes. Dependent measures were response time (RT), hit rate, false positives (FP), and true sensitivity (d'). Increased age correlated with increased sensitivity and RT; AD predicted even slower RT. Accuracy and RT were negatively correlated. Differences in FP were nonsignificant. CB correlated with impaired attention, working memory, and executive function. Advanced age and AD were associated with increased CB, perhaps due to declining memory and attention. CB could affect real-world tasks, like automobile driving.

  11. Comparison of antianginal efficacy of nifedipine and isosorbide dinitrate in chronic stable angina: a long-term, randomized, double-blind, crossover study

    International Nuclear Information System (INIS)

    Liang, C.S.; Coplin, B.; Wellington, K.

    1985-01-01

    Using a double-blind, crossover design, the comparative efficacy and safety of nifedipine and isosorbide dinitrate in the treatment of stable angina were studied in 34 patients. The study included a 2-week placebo washout period and two 6-week periods during which patients were randomized to either nifedipine or isosorbide dinitrate. The doses were titrated for each patient, and mean doses of the 2 drugs were comparable. A time-limited thallium treadmill test was performed at the end of each phase. Ischemic zone count rates were normalized to those of the nonischemic zone, and the change in this ratio with redistribution was calculated as reversible thallium defect. Two patients were discontinued from the study within 1 week after initiation of isosorbide dinitrate because of severe, intolerable headache. Two patients were withdrawn while receiving nifedipine: one had new congestive heart failure and the other had increasing angina. Of the remaining 30 patients who tolerated both drugs for at least 1 week, 4 patients from the isosorbide dinitrate group were either prematurely crossed over or discontinued from the study because of headache. One patient suffered headache from both drugs and was discontinued from the study. In the 30 patients, only nifedipine significantly reduced resting arterial pressure compared with baseline. Further, only nifedipine therapy resulted in significant decreases in the rate-pressure product and systolic pressure at a given workload. However, significant decreases in angina frequency, nitroglycerin consumption and exercise-induced maximum ST-segment depression and reversible thallium perfusion defect were produced by both nifedipine and isosorbide dinitrate

  12. Causes of blindness and visual impairment in Latin America.

    Science.gov (United States)

    Furtado, João M; Lansingh, Van C; Carter, Marissa J; Milanese, María F; Peña, Brenda N; Ghersi, Hernán A; Bote, Paula L; Nano, María E; Silva, Juan C

    2012-01-01

    We review what is known in each country of the Latin American region with regards to blindness and visual impairment and make some comparisons to Hispanic populations in the United States. Prevalence of blindness varied from 1.1% in Argentina to 4.1% in Guatemala in people 50 years of age and older, with the major cause being cataract. Diabetic retinopathy and glaucoma are starting to make serious inroads, although epidemiological data are limited, and age-related macular degeneration is now a concern in some populations. Infectious diseases such as trachoma and onchocerciasis are quickly diminishing. Although progress has been made, retinopathy of prematurity remains the major cause of childhood blindness. If VISION 2020 is to succeed, many more epidemiological studies will be needed to set priorities, although some can be of the Rapid Assessment of Avoidable Blindness design. Developing the infrastructure for screening and treatment of ophthalmic disease in Latin America continues to be a challenge. Copyright © 2012 Elsevier Inc. All rights reserved.

  13. 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

    Directory of Open Access Journals (Sweden)

    Lone V. Nielsen

    2018-01-01

    Full Text Available Higher-protein meals decrease hunger and increase satiety compared to lower-protein meals. However, no consensus exists about the different effects of animal and vegetable proteins on appetite. We investigated how a meal based on vegetable protein (fava beans/split peas affected ad libitum energy 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% of energy from protein, based on fava beans/split peas (28.5 g fiber, pork/veal or eggs supplemented with pea fiber to control for fiber content (28.5 g fiber, or eggs without supplementation of fiber (6.0 g fiber. Subjective appetite sensations were recorded at baseline and every half hour until the ad 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-balanced, fiber-matched meals based on vegetable protein (fava beans/split peas or animal protein (veal/pork or eggs had similar effects on ad libitum energy intake and appetite sensations.

  14. 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.

    Science.gov (United States)

    Sørensen, Louise B; Dyssegaard, Camilla B; Damsgaard, Camilla T; Petersen, Rikke A; Dalskov, Stine-Mathilde; Hjorth, Mads F; Andersen, Rikke; Tetens, Inge; Ritz, Christian; Astrup, Arne; Lauritzen, Lotte; Michaelsen, Kim F; Egelund, Niels

    2015-04-28

    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 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). 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 concentration performance (CP; primary outcome, n 693) or processing speed; however, the decrease in error percentage was 0·18 points smaller (Pschool year. The percentage of correct sentences also improved (Pperformance or outcomes from the LRS. In conclusion, school meals did not affect CP, but improved reading performance, which is a complex cognitive activity that involves inference, and increased errors related to impulsivity and inattention. These findings are worth examining in future trials.

  15. Effects of Soy Flour Fortified Bread Consumption on Cardiovascular Risk Factors According to APOE Genotypes in Overweight and Obese Adult Women: A Cross-over Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Sharifi-Zahabi, Elham; Entezari, Mohammad H; Maracy, Mohammad R

    2015-10-01

    Recent studies suggest that inclusion of soy product in the diet may have favorable effects on relief of cardiovascular diseases (CVDs) and risk factors. These effects might be associated with the presence of specific polymorphism in gene. The aim of this study was to examine the effects of consumption of soy flour fortified bread on cardiovascular risk factors in overweight and obese women according to APOE genotype. In a randomized cross-over clinical trial 30 overweight and obese women received a mild weight loss diet and assigned to a regular diet and a soy bread diet, each for 6 weeks and a washout period for 20 days. Subjects in the soy bread diet were asked to replace 120 grams of their daily usual bread intake with equal amount of soy bread. No significant effects of soy bread on serum lipid, systolic blood pressure and anthropometric indices were observed compared to the regular diet (p > 0.05). For diastolic blood pressure (DBP), comparison of mean differences between two groups showed a marginally significant effect of soy bread (p = 0.06). Compared to regular diet, soy bread had a significant effect on DBP in E2 genotype group (ε2/ε2) (p = 0.03). Having ε2 allele may influences responses of CVD risk factor to soy bread consumption. However more nutrigenetic studies are required.

  16. Effects of supplementation with n-3 polyunsaturated fatty acids on cognitive performance and cardiometabolic risk markers in healthy 51 to 72 years old subjects: a randomized controlled cross-over study

    Directory of Open Access Journals (Sweden)

    Nilsson Anne

    2012-11-01

    Full Text Available Abstract Background Higher plasma n-3 polyunsaturated fatty acids (PUFA have been associated with a lower risk of age related cognitive decline, and to beneficially affect cardiometabolic risk factors. A relation exists between metabolic disorders such as diabetes type 2 and cognitive decline. Results regarding the potential effects of n-3 PUFA on risk factors in healthy subjects are divergent, and studies regarding the possible relation between cardiometabolic parameters and cognitive performance are scarce. The objective was to evaluate the effects of five weeks intake of long chain n-3 PUFA on cognitive performance in healthy individuals, and to exploit the possible relation between outcomes in cognitive tests to cardiometabolic risk parameters. Methods Fish oil n-3 PUFA (3g daily were consumed during 5weeks separated by a 5 week washout period in a cross-over placebo controlled study, including 40 healthy middle aged to elderly subjects. Cognitive performance was determined by tests measuring working memory (WM and selective attention. Results Supplementation with n-3 PUFA resulted in better performance in the WM-test compared with placebo (p p p p = 0.05, and s-TNF-α (p = 0.05, were inversely related to the performance in cognitive tests. Conclusions Intake of n-3 PUFA improved cognitive performance in healthy subjects after five weeks compared with placebo. In addition, inverse relations were obtained between cardiometabolic risk factors and cognitive performance, indicating a potential of dietary prevention strategies to delay onset of metabolic disorders and associated cognitive decline.

  17. Consumption of a high-fat meal containing cheese compared with a vegan alternative lowers postprandial C-reactive protein in overweight and obese individuals with metabolic abnormalities: a randomised controlled cross-over study.

    Science.gov (United States)

    Demmer, Elieke; Van Loan, Marta D; Rivera, Nancy; Rogers, Tara S; Gertz, Erik R; German, J Bruce; Zivkovic, Angela M; Smilowitz, Jennifer T

    2016-01-01

    Dietary recommendations suggest decreased consumption of SFA to minimise CVD risk; however, not all foods rich in SFA are equivalent. To evaluate the effects of SFA in a dairy food matrix, as Cheddar cheese, v. SFA from a vegan-alternative test meal on postprandial inflammatory markers, a randomised controlled cross-over trial was conducted in twenty overweight or obese adults with metabolic abnormalities. Individuals consumed two isoenergetic high-fat mixed meals separated by a 1- to 2-week washout period. Serum was collected at baseline, and at 1, 3 and 6 h postprandially and analysed for inflammatory markers (IL-6, IL-8, IL-10, IL-17, IL-18, TNFα, monocyte chemotactic protein-1 (MCP-1)), acute-phase proteins C-reactive protein (CRP) and serum amyloid-A (SAA), cellular adhesion molecules and blood lipids, glucose and insulin. Following both high-fat test meals, postprandial TAG concentrations rose steadily (P vegan-alternative test meal. A treatment effect was not observed for any other inflammatory markers; however, for both test meals, multiple markers significantly changed from baseline over the 6 h postprandial period (IL-6, IL-8, IL-18, TNFα, MCP-1, SAA). Saturated fat in the form of a cheese matrix reduced the iAUC for CRP compared with a vegan-alternative test meal during the postprandial 6 h period. The study is registered at clinicaltrials.gov under NCT01803633.

  18. 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.

    Science.gov (United States)

    Nielsen, Lone V; Kristensen, Marlene D; Klingenberg, Lars; Ritz, Christian; Belza, Anita; Astrup, Arne; Raben, Anne

    2018-01-16

    Higher-protein meals decrease hunger and increase satiety compared to lower-protein meals. However, no consensus exists about the different effects of animal and vegetable proteins on appetite. We investigated how a meal based on vegetable protein (fava beans/split peas) affected ad libitum energy 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% of energy from protein), based on fava beans/split peas (28.5 g fiber), pork/veal or eggs supplemented with pea fiber to control for fiber content (28.5 g fiber), or eggs without supplementation of fiber (6.0 g fiber). Subjective appetite sensations were recorded at baseline and every half hour until the ad 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-balanced, fiber-matched meals based on vegetable protein (fava beans/split peas) or animal protein (veal/pork or eggs) had similar effects on ad libitum energy intake and appetite sensations.

  19. Structure, organization, and sequence of alpha satellite DNA from human chromosome 17: evidence for evolution by unequal crossing-over and an ancestral pentamer repeat shared with the human X chromosome.

    Science.gov (United States)

    Waye, J S; Willard, H F

    1986-09-01

    The centromeric regions of all human chromosomes are characterized by distinct subsets of a diverse tandemly repeated DNA family, alpha satellite. On human chromosome 17, the predominant form of alpha satellite is a 2.7-kilobase-pair higher-order repeat unit consisting of 16 alphoid monomers. We present the complete nucleotide sequence of the 16-monomer repeat, which is present in 500 to 1,000 copies per chromosome 17, as well as that of a less abundant 15-monomer repeat, also from chromosome 17. These repeat units were approximately 98% identical in sequence, differing by the exclusion of precisely 1 monomer from the 15-monomer repeat. Homologous unequal crossing-over is suggested as a probable mechanism by which the different repeat lengths on chromosome 17 were generated, and the putative site of such a recombination event is identified. The monomer organization of the chromosome 17 higher-order repeat unit is based, in part, on tandemly repeated pentamers. A similar pentameric suborganization has been previously demonstrated for alpha satellite of the human X chromosome. Despite the organizational similarities, substantial sequence divergence distinguishes these subsets. Hybridization experiments indicate that the chromosome 17 and X subsets are more similar to each other than to the subsets found on several other human chromosomes. We suggest that the chromosome 17 and X alpha satellite subsets may be related components of a larger alphoid subfamily which have evolved from a common ancestral repeat into the contemporary chromosome-specific subsets.

  20. 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

    Science.gov (United States)

    Nielsen, Lone V.; Kristensen, Marlene D.; Klingenberg, Lars; Belza, Anita

    2018-01-01

    Higher-protein meals decrease hunger and increase satiety compared to lower-protein meals. However, no consensus exists about the different effects of animal and vegetable proteins on appetite. We investigated how a meal based on vegetable protein (fava beans/split peas) affected ad libitum energy 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% of energy from protein), based on fava beans/split peas (28.5 g fiber), pork/veal or eggs supplemented with pea fiber to control for fiber content (28.5 g fiber), or eggs without supplementation of fiber (6.0 g fiber). Subjective appetite sensations were recorded at baseline and every half hour until the ad 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-balanced, fiber-matched meals based on vegetable protein (fava beans/split peas) or animal protein (veal/pork or eggs) had similar effects on ad libitum energy intake and appetite sensations. PMID:29337861

  1. Blind Signal Classification via Spare Coding

    Science.gov (United States)

    2016-04-10

    Blind Signal Classification via Sparse Coding Youngjune Gwon MIT Lincoln Laboratory gyj@ll.mit.edu Siamak Dastangoo MIT Lincoln Laboratory sia...achieve blind signal classification with no prior knowledge about signals (e.g., MCS, pulse shaping) in an arbitrary RF channel. Since modulated RF...classification method. Our results indicate that we can separate different classes of digitally modulated signals from blind sampling with 70.3% recall and 24.6

  2. Tactile maze solving in congenitally blind individuals

    DEFF Research Database (Denmark)

    Gagnon, Léa; Kupers, Ron; Schneider, Fabien C

    2010-01-01

    and environmental cues such as temperature and echolocation. We hypothesize that by limiting these cues, blind individuals will lose their advantage compared with controls in spatial navigation tasks. We therefore evaluated the performance of blind and sighted individuals in small-scale, tactile multiple T mazes....... Our results show that blindfolded sighted controls outperformed blind participants in the route-learning tasks. This suggests that, contrary to indoor large-scale spaces, navigational skills inside small-scale spaces benefit from visual experience....

  3. Finding Objects for Assisting Blind People

    OpenAIRE

    Yi, Chucai; Flores, Roberto W.; Chincha, Ricardo; Tian, YingLi

    2013-01-01

    Computer vision technology has been widely used for blind assistance, such as navigation and wayfinding. However, few camera-based systems are developed for helping blind or visually-impaired people to find daily necessities. In this paper, we propose a prototype system of blind-assistant object finding by camera-based network and matching-based recognition. We collect a dataset of daily necessities and apply Speeded-Up Robust Features (SURF) and Scale Invariant Feature Transform (SIFT) featu...

  4. A two-site, two-arm, 34-week, double-blind, parallel-group, randomized controlled trial of reduced nicotine cigarettes in smokers with mood and/or anxiety disorders: trial design and protocol

    Directory of Open Access Journals (Sweden)

    Sophia I. Allen

    2017-01-01

    Full Text Available Abstract Background The U.S. Food and Drug Administration can set standards for cigarettes that could include reducing their nicotine content. Such a standard should improve public health without causing unintended serious consequences for sub-populations. This study evaluates the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxicant exposure, and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders using a two-site, two-arm, double-blind, parallel group, randomized controlled trial (RCT in four phases over 34 weeks. Methods Adult smokers (N = 200 of 5 or more cigarettes per day will be randomized across two sites (Penn State and Massachusetts General. Participants must have not had a quit attempt in the prior month, nor be planning to quit in the next 6 months, meet criteria for a current or lifetime unipolar mood and/or anxiety disorder based on the structured Mini-International Neuropsychiatric Interview, and must not have an unstable medical or psychiatric condition. After a week of smoking their own cigarettes, participants receive two weeks of Spectrum research cigarettes with usual nicotine content (11.6 mg. After this baseline period, participants will be randomly assigned to continue smoking Spectrum research cigarettes that contain either (a Usual Nicotine Content (11.6 mg; or (b Reduced Nicotine Content: the nicotine content per cigarette is progressively reduced from approximately 11.6 mg to 0.2 mg in five steps over 18 weeks. At the end of the randomization phase, participants will be offered the choice to either (a quit smoking with assistance, (b continue smoking free research cigarettes, or (c return to purchasing their own cigarettes, for the final 12 weeks of the study. The primary outcome measure is blood cotinine; key secondary outcomes are: exhaled carbon monoxide, urinary total NNAL- 4-(methylnitrosamino-1-(3-pyridyl-1-butanol and 1-hydroxypyrene, oxidative

  5. Tactile spatial resolution in blind braille readers.

    Science.gov (United States)

    Van Boven, R W; Hamilton, R H; Kauffman, T; Keenan, J P; Pascual-Leone, A

    2000-06-27

    To determine if blind people have heightened tactile spatial acuity. Recently, studies using magnetic source imaging and somatosensory evoked potentials have shown that the cortical representation of the reading fingers of blind Braille readers is expanded compared to that of fingers of sighted subjects. Furthermore, the visual cortex is activated during certain tactile tasks in blind subjects but not sighted subjects. The authors hypothesized that the expanded cortical representation of fingers used in Braille reading may reflect an enhanced fidelity in the neural transmission of spatial details of a stimulus. If so, the quantitative limit of spatial acuity would be superior in blind people. The authors employed a grating orientation discrimination task in which threshold performance is accounted for by the spatial resolution limits of the neural image evoked by a stimulus. The authors quantified the psychophysical limits of spatial acuity at the middle and index fingers of 15 blind Braille readers and 15 sighted control subjects. The mean grating orientation threshold was significantly (p = 0.03) lower in the blind group (1.04 mm) compared to the sighted group (1.46 mm). The self-reported dominant reading finger in blind subjects had a mean grating orientation threshold of 0.80 mm, which was significantly better than other fingers tested. Thresholds at non-Braille reading fingers in blind subjects averaged 1.12 mm, which were also superior to sighted subjects' performances. Superior tactile spatial acuity in blind Braille readers may represent an adaptive, behavioral correlate of cortical plasticity.

  6. Blind Grid Scoring Record No. 290

    National Research Council Canada - National Science Library

    Overbay, Larry; Robitaille, George

    2005-01-01

    ...) utilizing the APG Standardized UXO Technology Demonstration Site Blind Grid. Scoring Records have been coordinated by Larry Overbay and the Standardized UXO Technology Demonstration Site Scoring Committee...