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Sample records for randomized three-way crossover

  1. A randomized three-way cross-over study in healthy pituitary-suppressed women to compare the bioavailability of human chorionic gonadotrophin (Pregnyl®) after intramuscular and subcutaneous administration

    NARCIS (Netherlands)

    Mannaerts, B.M.J.L.; Geurts, T.B.P.; Odink, J.

    1998-01-01

    The objective of this study was to compare the bioavailability of s.c. and i.m. administration of human chorionic gonadotrophin (HCG; Pregnyl®). In a randomized, single centre, three-way cross-over study, 18 healthy pituitary-suppressed volunteers were assigned to single HCG injections of 5000 and

  2. Increased Erythrocyte Eicosapentaenoic Acid and Docosahexaenoic Acid Are Associated With Improved Attention and Behavior in Children With ADHD in a Randomized Controlled Three-Way Crossover Trial.

    Science.gov (United States)

    Milte, Catherine M; Parletta, Natalie; Buckley, Jonathan D; Coates, Alison M; Young, Ross M; Howe, Peter R C

    2015-11-01

    To investigate effects of omega-3 polyunsaturated fatty acids (n-3 PUFA) docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) on attention, literacy, and behavior in children with ADHD. Ninety children were randomized to consume supplements high in EPA, DHA, or linoleic acid (control) for 4 months each in a crossover design. Erythrocyte fatty acids, attention, cognition, literacy, and Conners' Parent Rating Scales (CPRS) were measured at 0, 4, 8, 12 months. Fifty-three children completed the treatment. Outcome measures showed no significant differences between the three treatments. However, in children with blood samples (n = 76-46), increased erythrocyte EPA + DHA was associated with improved spelling (r = .365, p DHA and EPA via dietary supplementation may improve behavior, attention, and literacy in children with ADHD. © The Author(s) 2013.

  3. Effect of volume loading with 1 liter intravenous infusions of 0.9% saline, 4% succinylated gelatine (Gelofusine) and 6% hydroxyethyl starch (Voluven) on blood volume and endocrine responses: a randomized, three-way crossover study in healthy volunteers.

    Science.gov (United States)

    Lobo, Dileep N; Stanga, Zeno; Aloysius, Mark M; Wicks, Catherine; Nunes, Quentin M; Ingram, Katharine L; Risch, Lorenz; Allison, Simon P

    2010-02-01

    To study the changes in blood volume and hormones controlling sodium and water homeostasis after infusions of 0.9% saline, Gelofusine (4% succinylated gelatin in 0.7% saline, weight-average molecular weight 30 kD), and Voluven (6% hydroxyethyl starch in 0.9% saline, weight-average molecular weight 130 kD) in healthy volunteers. Randomized, three-way crossover study. University teaching hospital. Ten healthy adult male volunteers. Volunteers received 1-L infusions of 0.9% saline, Gelofusine, and Voluven over 1 hr on three occasions. Body weight, hematocrit, serum biochemistry, and plasma concentrations of vasopressin, aldosterone, brain natriuretic peptide, and total renin were measured before infusion and hourly thereafter for 6 hrs. Changes in body water, blood volume, and extravascular fluid volume were calculated. Although changes in body weight (total body water) after the infusions were similar, blood volume expansion by the two colloids was significantly greater than that produced by 0.9% saline (p < .01). At the end of infusions, 68%, 21%, and 16% of the infused volumes of 0.9% saline, Gelofusine, and Voluven, respectively, had escaped from the intravascular space to the extravascular space. Over the 6 hrs, the magnitude and duration of blood volume expansion by the two colloids were similar (p = .70). There were no significant differences in urinary volume, osmolality, and sodium content after the three infusions. Hormonal changes were similar after the three infusions, with the increase in natriuretic peptide being transient. The reduction in aldosterone and total renin concentrations was more sustained. The effects of Gelofusine and Voluven were similar despite the 100 kD difference in weight-average molecular weight. Excretion of an acute fluid load containing sodium and chloride may be dependent on a sustained suppression of the renin-angiotensin-aldosterone system rather than on natriuretic peptides.

  4. Bioequivalence of generic alendronate sodium tablets (70 mg to Fosamax® tablets (70 mg in fasting, healthy volunteers: a randomized, open-label, three-way, reference-replicated crossover study

    Directory of Open Access Journals (Sweden)

    Zhang Y

    2017-07-01

    Full Text Available Yifan Zhang,1 Xiaoyan Chen,1 Yunbiao Tang,2 Youming Lu,1 Lixia Guo,1 Dafang Zhong1 1State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 2Department of Pharmacy, The General Hospital of Shenyang Military Region, Shenyang, People’s Republic of China Purpose: The aim of this study was to evaluate the bioequivalence of a generic product 70 mg alendronate sodium tablets with the reference product Fosamax® 70 mg tablet. Materials and methods: A single-center, open-label, randomized, three-period, three-sequence, reference-replicated crossover study was performed in 36 healthy Chinese male volunteers under fasting conditions. In each study period, the volunteers received a single oral dose of the generic or reference product (70 mg. Blood samples were collected at pre-dose and up to 8 h after administration. The bioequivalence of the generic product to the reference product was assessed using the US Food and Drug Administration (FDA and European Medicines Agency (EMA reference-scaled average bioequivalence (RSABE methods. Results: The average maximum concentrations (Cmax of alendronic acid were 64.78±43.76, 56.62±31.95, and 60.15±37.12 ng/mL after the single dose of the generic product and the first and second doses of the reference product, respectively. The areas under the plasma concentration–time curves from time 0 to the last timepoint (AUC0–t were 150.36±82.90, 148.15±85.97, and 167.11±110.87 h·ng/mL, respectively. Reference scaling was used because the within-subject standard deviations of the reference product (sWR for Cmax and AUC0–t were all higher than the cutoff value of 0.294. The 95% upper confidence bounds were -0.16 and -0.17 for Cmax and AUC0–t, respectively, and the point estimates for the generic/reference product ratio were 1.08 and 1.00, which satisfied the RSABE acceptance criteria of the FDA. The 90% CIs for Cmax and AUC0–t were 90.35%–129

  5. Investigation of the effect of food and omeprazole on the relative bioavailability of a single oral dose of 240 mg faldaprevir, a selective inhibitor of HCV NS3/4 protease, in an open-label, randomized, three-way cross-over trial in healthy participants.

    Science.gov (United States)

    Wu, Jing; Gießmann, Thomas; Lang, Benjamin; Elgadi, Mabrouk; Huang, Fenglei

    2016-04-01

    This study was conducted to investigate the effect of food and coadministration of omeprazole on the relative bioavailability (BA) of faldaprevir (FDV). Fifteen healthy participants participated in this open-label, randomized, three-way cross-over study. Faldaprevir was administered as a 240 mg single dose during fasting state, following intake of a high-fat breakfast, or following omeprazole 40 mg q.d. dosing for 5 days. PK samples were collected on the day of faldaprevir administration. We found geometric mean (gMean) AUC0-∞ values for faldaprevir of 48 200, 37 900 and 36 000 ng h/ml under the fed, fasted and omeprazole coadministration conditions respectively. Similarly, gMean Cmax values for faldaprevir were 2600, 2030, 1920 ng/ml under the same respective conditions. The adjusted gMean ratio between the fed and fasted condition was approximately 120% for both AUC0-∞ and Cmax , while the ratio of omeprazole coadministration to fasted condition was approximately 94%. Faldaprevir was safe and well tolerated in the study. Administration of a single dose of 240 mg faldaprevir after high-fat breakfast led to a modest, clinically irrelevant increase in faldaprevir exposure, while coadministration of omeprazole did not influence faldaprevir exposure. © 2016 Royal Pharmaceutical Society, Journal of Pharmacy and Pharmacology.

  6. The design of cluster randomized crossover trials

    NARCIS (Netherlands)

    Rietbergen, C.; Moerbeek, M.

    2011-01-01

    The inefficiency induced by between-cluster variation in cluster randomized (CR) trials can be reduced by implementing a crossover (CO) design. In a simple CO trial, each subject receives each treatment in random order. A powerful characteristic of this design is that each subject serves as its own

  7. Randomized Crossover Trial of Silicone Hydrogel Presbyopic Contact Lenses.

    Science.gov (United States)

    Sivardeen, Ahmed; Laughton, Deborah; Wolffsohn, James S

    2016-02-01

    To assess the performance of four commercially available silicone hydrogel multifocal monthly contact lens designs against monovision. A double-masked randomized crossover trial of Air Optix Aqua multifocal, PureVision 2 for Presbyopia, Acuvue OASYS for Presbyopia, Biofinity multifocal, and monovision with Biofinity contact lenses was conducted on 35 presbyopes (54.3 ± 6.2 years). After 4 weeks of wear, visual performance was quantified by high- and low-contrast visual acuity under photopic and mesopic conditions, reading speed, defocus curves, stereopsis, halometry, aberrometry, Near Activity Visual Questionnaire rating, and subjective quality of vision scoring. Bulbar, limbal, and palpebral hyperemia and corneal staining were graded to monitor the impact of each contact lens on ocular physiology. High-contrast photopic visual acuity (p = 0.102), reading speed (F = 1.082, p = 0.368), and aberrometry (F = 0.855, p = 0.493) were not significantly different between presbyopic lens options. Defocus curve profiles (p lenses. Although ocular aberration variation between individuals largely masks the differences in optics between current multifocal contact lens designs, certain design strategies can outperform monovision, even in early presbyopes.

  8. Phytochemical Pharmacokinetics and Bioactivity of Oat and Barley Flour: A Randomized Crossover Trial

    Directory of Open Access Journals (Sweden)

    Caleigh M. Sawicki

    2016-12-01

    Full Text Available While dietary fiber plays an important role in the health benefits associated with whole grain consumption, other ingredients concentrated in the outer bran layer, including alkylresorcinols, lignans, phenolic acids, phytosterols, and tocols, may also contribute to these outcomes. To determine the acute bioavailability and pharmacokinetics of the major phytochemicals found in barley and oats, we conducted a randomized, three-way crossover trial in 13 healthy subjects, aged 40–70 years with a body mass index (BMI of 27–35.9 kg/m2. After a two-day run-in period following a diet low in phytochemicals, subjects were randomized to receive muffins made with either 48 g whole oat flour, whole barley flour, or refined wheat flour plus cellulose (control, with a one-week washout period between each intervention. At the same time, an oral glucose tolerance test was administered. In addition to plasma phytochemical concentrations, glucose and insulin responses, biomarkers of antioxidant activity, lipid peroxidation, inflammation, and vascular remodeling were determined over a 24-h period. There was no significant effect on acute bioavailability or pharmacokinetics of major phytochemicals. Administered concurrently with a glucose bolus, the source of whole grains did not attenuate the post-prandial response of markers of glucoregulation and insulin sensitivity, inflammation, nor vascular remodeling compared to the refined grain control. No significant differences were observed in the bioavailability or postprandial effects between whole-oat and whole-barley compared to a refined wheat control when administered with a glucose challenge. These null results may be due, in part, to the inclusion criteria for the subjects, dose of the whole grains, and concurrent acute administration of the whole grains with the glucose bolus.

  9. Nutrition intervention for migraine: a randomized crossover trial.

    Science.gov (United States)

    Bunner, Anne E; Agarwal, Ulka; Gonzales, Joseph F; Valente, Francesca; Barnard, Neal D

    2014-10-23

    Limited evidence suggests that dietary interventions may offer a promising approach for migraine. The purpose of this study was to determine the effects of a low-fat plant-based diet intervention on migraine severity and frequency. Forty-two adult migraine sufferers were recruited from the general community in Washington, DC, and divided randomly into two groups. This 36-week crossover study included two treatments: dietary instruction and placebo supplement. Each treatment period was 16 weeks, with a 4-week washout between. During the diet period, a low-fat vegan diet was prescribed for 4 weeks, after which an elimination diet was used. Participants were assessed at the beginning, midpoint, and end of each period. Significance was determined using student's t-tests. Worst headache pain in last 2 weeks, as measured by visual analog scale, was initially 6.4/10 cm (SD 2.1 cm), and declined 2.1 cm during the diet period and 0.7 cm during the supplement period (p=0.03). Average headache intensity (0-10 scale) was initially 4.2 (SD 1.4) per week, and this declined by 1.0 during the diet period and by 0.5 during the supplement period (p=0.20). Average headache frequency was initially 2.3 (SD 1.8) per week, and this declined by 0.3 during the diet period and by 0.4 during the supplement period (p=0.61). The Patient's Global Impression of Change showed greater improvement in pain during the diet period (pnutritional approach may be a useful part of migraine treatment, but that methodologic issues necessitate further research. Clinicaltrials.gov, NCT01699009 and NCT01547494.

  10. Video game playing increases food intake in adolescents: a randomized crossover study

    National Research Council Canada - National Science Library

    Chaput, Jean-Philippe; Visby, Trine; Nyby, Signe; Klingenberg, Lars; Gregersen, Nikolaj T; Tremblay, Angelo; Astrup, Arne; Sjödin, Anders

    2011-01-01

    .... With the use of a randomized crossover design, 22 healthy, normal-weight, male adolescents (mean ± SD age: 16.7 ± 1.1 y) completed two 1-h experimental conditions, namely video game play and rest in a sitting position, followed by an ad libitum lunch...

  11. A Randomized Double-Blind Crossover Study of Phase-Shift Sound Therapy for Tinnitus

    NARCIS (Netherlands)

    Heijneman, Karin M.; de Kleine, Emile; van Dijk, Pim

    Objective. The purpose of this study was to compare the efficacy of the treatment of tinnitus with a phase-shifting pure tone to that of the same tone treatment without phase shifting. Study Design. A double-blind crossover randomized controlled trial. Setting. This study was conducted at the

  12. Does epicatechin contribute to the acute vascular function effects of dark chocolate? A randomized, crossover study

    NARCIS (Netherlands)

    Dower, James I.; Geleijnse, Marianne; Kroon, Paul A.; Philo, Mark; Mensink, Marco; Kromhout, Daan; Hollman, Peter C.H.

    2016-01-01

    Scope: Cocoa, rich in flavan-3-ols, improves vascular function, but the contribution of specific flavan-3-ols is unknown. We compared the effects of pure epicatechin, a major cocoa flavan-3-ol, and chocolate. Methods and results: In a randomized crossover study, twenty healthy men (40-80 years)

  13. A randomized crossover study of bee sting therapy for multiple sclerosis

    NARCIS (Netherlands)

    Wesselius, T; Heersema, DJ; Mostert, JP; Heerings, M; Admiraal-Behloul, F; Talebian, A; van Buchem, MA; De Keyser, J

    2005-01-01

    Background: Bee sting therapy is increasingly used to treat patients with multiple sclerosis (MS) in the belief that it can stabilize or ameliorate the disease. However, there are no clinical studies to justify its use. Methods: In a randomized, crossover study, we assigned 26 patients with

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

    DEFF Research Database (Denmark)

    Nielsen, Jimmi; Thode, Dorrit; Stenager, Elsebeth

    2012-01-01

    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...

  15. 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...

  16. Intensive pediatric constraint-induced therapy for children with cerebral palsy: randomized, controlled, crossover trial.

    Science.gov (United States)

    Deluca, Stephanie C; Echols, Karen; Law, Charles R; Ramey, Sharon L

    2006-11-01

    A randomized crossover trial of a new form of pediatric rehabilitation was conducted with 18 children with hemiparesis. Half were randomly assigned to receive pediatric constraint-induced therapy involving constraint of the functional upper extremity and intensive therapy with the hemiparetic upper extremity. Controls received conventional physical and occupational therapy and then were crossed over to receive pediatric constraint-induced therapy. Pediatric constraint-induced therapy produced significantly greater gains than conventional rehabilitation services.

  17. Characterization of three-way automotive catalysts

    Energy Technology Data Exchange (ETDEWEB)

    Kenik, E.A.; More, K.L. [Oak Ridge National Lab., TN (United States); LaBarge, W. [Delphi Automotive Systems, Flint, MI (United States)] [and others

    1997-04-01

    The CRADA between Delphi Automotive Systems (Delphi; formerly General Motors - AC Delco, Systems) and Lockheed Martin Energy Research (LMER) on automotive catalysts was completed at the end of FY96, after a ten month, no-cost extension. The CRADA was aimed at improved performance and lifetime of noble metal based three-way-catalysts (TWC), which are the primary catalytic system for automotive emission control systems. While these TWC can meet the currently required emission standards, higher than optimum noble metal loadings are often required to meet lifetime requirements. In addition, more stringent emission standards will be imposed in the near future, demanding improved performance and service life from these catalysts. Understanding the changes of TWC conversion efficiency with ageing is a critical need in improving these catalysts. Initially in a fresh catalyst, the active material is often distributed on a very fine scale, approaching single atoms or small atomic clusters. As such, a wide range of analytical techniques have been employed to provide high spatial resolution characterization of the evolving state of the catalytic material.

  18. Retromolar laryngoscopy: a randomized crossover vocal cords visualization study.

    Science.gov (United States)

    Reiterer, Christian; Waltl, Barbara; Kabon, Barbara; Schramm, Wolfgang

    2017-08-01

    Vocal cords visualization is a major determinant for successful tracheal intubation. The aim of our study was to compare vocal cord visualization by using conventional direct laryngoscopy with retromolar direct laryngoscopy in patients with an existing retromolar gap at the right mandible. We enrolled 100 adults needing endotracheal intubation for elective surgery. In each patient, the vocal cords were visualized and scored according to Cormack and Lehane with a Macintosh blade #3 for conventional technique and with a Miller blade #4 for the retromolar technique in a randomized sequence. Finally, tracheal intubation was performed primarily by conventional laryngoscopy and in the case of failing retromolar laryngoscopy was used as the rescue method. Overall 100 laryngoscopies with the conventional method and 100 laryngoscopies with the retromolar method were scored according to Cormack and Lehane. The retromolar technique achieved significant (P=0.000003) lower Cormack and Lehane scores compared to the conventional technique. In eleven patients, intubation by conventional laryngoscopy failed and seven of those patients were successfully intubated by the retromolar technique. A BURP-maneuver significantly improved vocal cord visualization during both methods. In summary, laryngoscopy via the retromolar method by using a Miller blade #4 lead to a significantly better vocal cord visualization compared to the conventional method performed with a Macintosh blade #3 in patients with an existing retromolar gap on the right side.

  19. Topical Administration of Pirfenidone Increases Healing of Chronic Diabetic Foot Ulcers: A Randomized Crossover Study

    OpenAIRE

    Marcela Janka-Zires; Paloma Almeda-Valdes; Ana Cecilia Uribe-Wiechers; Sonia Citlali Juárez-Comboni; Joel López-Gutiérrez; Jarod Jazek Escobar-Jiménez; Francisco J Gómez-Pérez

    2016-01-01

    Only 30 percent of chronic diabetic foot ulcers heal after 20 weeks of standard treatment. Pirfenidone is a drug with biological, anti-inflammatory, and antifibrotic effects. The aim of this study was to evaluate the effect of topical pirfenidone added to conventional treatment in noninfected chronic diabetic foot ulcers. This was a randomized crossover study. Group 1 received topical pirfenidone plus conventional treatment for 8 weeks; after this period, they were switched to receive convent...

  20. Acceptance and usability of different sunscreen formulations among outdoor workers: a randomized, single-blind, cross-over study

    National Research Council Canada - National Science Library

    Bauer, Andrea; Hault, Kathrin; Püschel, Andrea; Rönsch, Henriette; Knuschke, Peter; Beissert, Stefan

    2014-01-01

    Adequate sun protection is often neglected during occupational outdoor work. To investigate the acceptance and usability of sunscreens during outdoor work a single-blind, randomized-controlled, cross-over trial was performed in 40 subjects...

  1. A randomized crossover study of web-based media literacy to prevent smoking.

    Science.gov (United States)

    Shensa, Ariel; Phelps-Tschang, Jane; Miller, Elizabeth; Primack, Brian A

    2016-02-01

    Feasibly implemented Web-based smoking media literacy (SML) programs have been associated with improving SML skills among adolescents. However, prior evaluations have generally had weak experimental designs. We aimed to examine program efficacy using a more rigorous crossover design. Seventy-two ninth grade students completed a Web-based SML program based on health behavior theory and implemented using a two-group two-period crossover design. Students were randomly assigned by classroom to receive media literacy or control interventions in different sequences. They were assessed three times, at baseline (T0), an initial follow-up after the first intervention (T1) and a second follow-up after the second intervention (T2). Crossover analysis using analysis of variance demonstrated significant intervention coefficients, indicating that the SML condition was superior to control for the primary outcome of total SML (F = 11.99; P < 0.001) and for seven of the nine individual SML items. Results were consistent in sensitivity analyses conducted using non-parametric methods. There were changes in some exploratory theory-based outcomes including attitudes and normative beliefs but not others. In conclusion, while strength of the design of this study supports and extends prior findings around effectiveness of SML programs, influences on theory-based mediators of smoking should be further explored. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  2. Melatonin improves sleep in children with epilepsy: a randomized, double-blind, crossover study.

    Science.gov (United States)

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

    2015-05-01

    Insomnia, especially maintenance insomnia, is widely prevalent in epilepsy. Although melatonin is commonly used, limited data address its efficacy. We performed a randomized, double-blind, placebo-controlled, crossover study to identify the effects of melatonin on sleep and seizure control in children with epilepsy. Eleven prepubertal, developmentally normal children aged 6-11 years with epilepsy were randomized by a software algorithm to receive placebo or a 9-mg sustained release (SR) melatonin formulation for four weeks, followed by a one-week washout and a four-week crossover condition. The pharmacy performed blinding; patients, parents, and study staff other than a statistician were blinded. The primary outcomes were sleep onset latency and wakefulness after sleep onset (WASO) measured on polysomnography. The secondary outcomes included seizure frequency, epileptiform spike density per hour of sleep on electroencephalogram (EEG), and reaction time (RT) measures on psychomotor vigilance task (PVT). Statistical tests appropriate for crossover designs were used for the analysis. Data were analyzed from 10 subjects who completed the study. Melatonin decreased sleep latency (mean difference, MD, of 11.4 min and p = 0.02) and WASO (MD of 22 min and p = 0.04) as compared to placebo. No worsening of spike density or seizure frequency was seen. Additionally, slow-wave sleep duration and rapid eye movement (REM) latency were increased with melatonin and REM sleep duration was decreased. These changes were statistically significant. Worsening of headache was noted in one subject with migraine on melatonin. SR melatonin resulted in statistically significant decreases in sleep latency and WASO. No clear effects on seizures were observed, but the study was too small to allow any conclusions to be drawn in this regard. Copyright © 2015 Elsevier B.V. All rights reserved.

  3. Bootstrap confidence intervals for three-way component methods

    NARCIS (Netherlands)

    Kiers, H.A.L.; Weigh, C.; Gaul, W.

    2005-01-01

    The two most common component methods for the analysis of three-way data, CANDECOMP/PARAFAC (CP) and Tucker3 analysis, are used to summarize a three-mode three-way data set by means of a number of component matrices, and, in case of Tucker3, a core array, Until recently, no procedures for computing

  4. Tetrahydrocannabinol in Behavioral Disturbances in Dementia: A Crossover Randomized Controlled Trial.

    Science.gov (United States)

    van den Elsen, Geke A H; Ahmed, Amir I A; Verkes, Robbert-Jan; Feuth, Ton; van der Marck, Marjolein A; Olde Rikkert, Marcel G M

    2015-12-01

    Neuropsychiatric symptoms (NPS) are highly prevalent in dementia, but effective pharmacotherapy without important side effects is lacking. This study aims to assess the efficacy and safety of oral tetrahydrocannabinol (THC) in the treatment of NPS in dementia. Randomized, double-blind, placebo-controlled, repeated crossover trial, consisting of six treatment blocks of 2 weeks each. Two hospital sites in The Netherlands, September 2011 to December 2013. Patients with dementia and clinically relevant NPS. Within each block THC (0.75 mg twice daily in blocks 1-3 and 1.5 mg twice daily in blocks 4-6) and placebo were administered in random order for 3 consecutive days, followed by a 4-day washout. Primary outcome was change in Neuropsychiatric Inventory (NPI) score. Analyses were performed intention-to-treat. Data from all subjects were used without imputation. Sample size required for a power of 80% was 20 patients, because of repeated crossover. 22 patients (15 men, mean age 76.4 [5.3] years) were included, of whom 20 (91%) completed the trial. THC did not reduce NPI compared to placebo (blocks 1-3: 1.8, 97.5% CI: -2.1 to 5.8; blocks 4-6: -2.8, 97.5% CI: -7.4 to 1.8). THC was well tolerated, as assessed by adverse event monitoring, vital signs, and mobility. The incidence of adverse events was similar between treatment groups. Four non-related serious adverse events occurred. This is the largest randomized controlled trial studying the efficacy of THC for NPS, to date. Oral THC did not reduce NPS in dementia, but was well tolerated by these vulnerable patients, supporting future higher dosing studies. Copyright © 2015 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

  5. Breathing during sleep in menopause: a randomized, controlled, crossover trial with estrogen therapy.

    Science.gov (United States)

    Polo-Kantola, Päivi; Rauhala, Esa; Helenius, Hans; Erkkola, Risto; Irjala, Kerttu; Polo, Olli

    2003-07-01

    To evaluate the prevalence of different types of nocturnal breathing abnormalities in postmenopausal women and the effect of estrogen replacement therapy (ERT) on nocturnal breathing. A prospective, randomized, placebo-controlled, double-blind, crossover study was completed by 62 of 71 recruited healthy women. The first 3-month treatment period with either estrogen or placebo was followed by placebo washout for a month and then by a second treatment period with crossover to either estrogen or placebo. On a night after each treatment period, sleep was monitored with polysomnography, and breathing was assessed with a static-charge-sensitive bed and oximeter. For the respiratory variables, a sample size of 48 subjects was sufficient to give statistical power of 85% with a significance level of P arterial oxyhemoglobin saturation. Partial upper airway obstruction is the most prevalent form of sleep-disordered breathing, occurring ten times more frequently than sleep apnea in postmenopausal women. Unopposed estrogen replacement therapy has only a minor effect on sleep apnea and has no effect on partial airway obstruction.

  6. Effect of Anodal Transcranial Direct Current Stimulation on Autism: A Randomized Double-Blind Crossover Trial

    Directory of Open Access Journals (Sweden)

    Anuwat Amatachaya

    2014-01-01

    Full Text Available The aim of this study was to evaluate the Childhood Autism Rating Scale (CARS, Autism Treatment Evaluation Checklist (ATEC, and Children’s Global Assessment Scale (CGAS after anodal transcranial direct current stimulation (tDCS in individuals with autism. Twenty patients with autism received 5 consecutive days of both sham and active tDCS stimulation (1 mA in a randomized double-blind crossover trial over the left dorsolateral prefrontal cortex (F3 for 20 minutes in different orders. Measures of CARS, ATEC, and CGAS were administered before treatment and at 7 days posttreatment. The result showed statistical decrease in CARS score (P<0.001. ATEC total was decreased from 67.25 to 58 (P<0.001. CGAS was increased at 7 days posttreatment (P=0.042. Our study suggests that anodal tDCS over the F3 may be a useful clinical tool in autism.

  7. Pacemaker current inhibition in experimental human cardiac sympathetic activation: a double-blind, randomized, crossover study.

    Science.gov (United States)

    Schroeder, C; Heusser, K; Zoerner, A A; Großhennig, A; Wenzel, D; May, M; Sweep, F C G J; Mehling, H; Luft, F C; Tank, J; Jordan, J

    2014-06-01

    Hyperpolarization-activated, cyclic nucleotide-gated 4 (HCN4) channels comprise the final pathway for autonomic heart rate (HR) regulation. We hypothesized that HCN4 inhibition could reverse autonomic imbalance in a human model of cardiac sympathetic activation. Nineteen healthy men ingested oral metoprolol+reboxetine, ivabradine+reboxetine, or placebo+reboxetine in a double-blind, randomized, crossover fashion. We assessed HR, blood pressure (BP), stroke volume, and cardiac output during rest and profound orthostatic stress. HR variability, BP variability, and baroreflex sensitivity were analyzed. Metoprolol, but not ivabradine, decreased resting HR and BP. Ivabradine attenuated the HR increase to orthostatic stress, albeit to a lesser extent than metoprolol. Stroke volume and cardiac output at a given HR were significantly lower with metoprolol. Unlike metoprolol, ivabradine did not affect HR variability, BP variability, or baroreflex sensitivity. Ivabradine attenuates sympathetic influences on HR at the sinus node level, leaving myocardial sympathetic activation unopposed. Reversal of parasympathetic dysfunction by ivabradine appears limited.

  8. Topical minocycline and tetracycline rinses in treatment of recurrent aphthous stomatitis: a randomized cross-over study.

    Science.gov (United States)

    Gorsky, Meir; Epstein, Joel; Rabenstein, Shira; Elishoov, Hanita; Yarom, Noam

    2007-05-01

    Recurrent aphthous stomatitis (RAS) is a common ulcerative condition of the oral mucosa. We assessed minocycline and tetracycline oral rinses in patients with frequent episodes of RAS in a clinical randomized crossover trial. Seventeen patients with high frequency recurrent minor RAS were randomly allocated to a cross-over topical therapy with 0.2 percent minocycline or 0.25 percent tetracycline aqueous solution mouthwash. The minimum interval between the cross-over was 30 days. The intensity of pain was recorded daily using a visual analogue scale. Minocycline mouthwashes as compared to topical tetracycline rinses resulted in significantly improved pain control, by reducing the severity and duration of pain. Topical minocycline rinse may be a potential treatment for other mucosal diseases that result in mucosal ulceration and pain.

  9. Does hyperventilation improve operating condition during supratentorial craniotomy? A multicenter randomized crossover trial.

    Science.gov (United States)

    Gelb, Adrian W; Craen, Rosemary A; Rao, G S Umamaheswara; Reddy, K R Madhusudan; Megyesi, Joseph; Mohanty, Bibek; Dash, Hari H; Choi, Kai C; Chan, Mathew T V

    2008-02-01

    Hyperventilation has been an integral, but poorly validated part of neuroanesthetic practice. We conducted a two-period, crossover, randomized trial to evaluate surgeon-assessed brain bulk and measured intracranial pressure (ICP) in patients undergoing craniotomy for removal of supratentorial brain tumors during moderate hypocapnia or normocapnia. Two-hundred and seventy-five adult patients with supratentorial brain tumors were randomized to one of two treatment sequences: hyperventilation (arterial carbon dioxide tension, PaCO2 = 25 +/- 2 mm Hg) followed by normoventilation (PaCO2 = 37 +/- 2 mm Hg) or normoventilation followed by hyperventilation. Ventilation and end-tidal CO2 tension were kept constant for 20 min. Patients were also randomly assigned to receive a propofol infusion or isoflurane anesthesia. At the end of each study period, subdural ICP was measured and the neurosurgeon, blinded to the treatment group, was asked to rate the brain bulk using a four-point scale. Using a generalized estimation equation model, we found that hyperventilation decreased the risk of increased brain bulk by 45%, P = 0.004, 95% confidence intervals 22% to 61%, and the number needed to treat was 8. The mean (+/-SD) ICP during hyperventilation, 12.3 +/- 8.1 mm Hg, was lower than that during normoventilation, 16.2 +/- 9.6 mm Hg, P hyperventilation improves surgeon-assessed brain bulk which was associated with a decrease in ICP.

  10. A Randomized, Double-Blind, Crossover Comparison of MK-0929 and Placebo in the Treatment of Adults with ADHD

    Science.gov (United States)

    Rivkin, Anna; Alexander, Robert C.; Knighton, Jennifer; Hutson, Pete H.; Wang, Xiaojing J.; Snavely, Duane B.; Rosah, Thomas; Watt, Alan P.; Reimherr, Fred W.; Adler, Lenard A.

    2012-01-01

    Objective: Preclinical models, receptor localization, and genetic linkage data support the role of D4 receptors in the etiology of ADHD. This proof-of-concept study was designed to evaluate MK-0929, a selective D4 receptor antagonist as treatment for adult ADHD. Method: A randomized, double-blind, placebo-controlled, crossover study was conducted…

  11. 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...

  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. Comparing patient characteristics, type of intervention, control, and outcome (PICO) queries with unguided searching: a randomized controlled crossover trial

    NARCIS (Netherlands)

    Hoogendam, A.; Vries Robbé, P.F. de; Overbeke, A.J.P.M.

    2012-01-01

    BACKGROUND: Translating a question into a query using patient characteristics, type of intervention, control, and outcome (PICO) should help answer therapeutic questions in PubMed searches. The authors performed a randomized crossover trial to determine whether the PICO format was useful for quick

  14. Thai traditional massage increases biochemical markers of bone formation in postmenopausal women: a randomized crossover trial.

    Science.gov (United States)

    Saetung, Sunee; Chailurkit, La-Or; Ongphiphadhanakul, Boonsong

    2013-03-25

    The effect of massage therapy on bone metabolism in adults has only scarcely been explored. In a randomized crossover trial, we investigated the skeletal effect of Thai traditional massage by examining the changes in biochemical markers of bone turnover. Forty-eight postmenopausal women participated in the study. All volunteers were randomized to a 2-hour session of Thai traditional massage twice a week for 4 weeks and a 4-week control period after a 2-week washout, or vice versa. Twenty-one subjects were allocated to receiving Thai traditional massage first, followed by the control period, while 27 were initially allocated to the control period. Serum P1NP increased significantly after Thai traditional massage (P women whose ages were in the middle and higher tertiles and whose heights were in the lower and middle tertiles (n = 22) had a 14.8 ± 3.3% increase in P1NP after massage (P women (n = 26). Thai traditional massage results in an increase in bone formation as assessed by serum P1NP, particularly in postmenopausal women who are older and have a smaller body build. Future studies with larger samples and additional design features are warranted. ClinicalTrials.gov : NCT01627028.

  15. Randomized crossover trial studying the effect of music on examination anxiety.

    Science.gov (United States)

    Lai, Hui-Ling; Chen, Pin-Wen; Chen, Chia-Jung; Chang, Hui-Kuan; Peng, Tai-Chu; Chang, Fwu-Mei

    2008-11-01

    The purpose of this study was to assess the effect of lento music on examination anxiety among nursing students. A randomized crossover classroom-based trial was conducted. Thirty-eight students with a mean age of 19.4 years (SD = .54) were randomly assigned to either a music/silence or a silence/music group sequence. The students in the music group were given a 40-min group-based music intervention in a classroom, whereas the students in the silence group received the regular test without music. Using paired t-tests, there were no significant different in pretest scores for state anxiety, examination anxiety, finger temperature and pulse rate between the two conditions. Nonetheless, the findings indicated that music intervention did effectively decrease examination anxiety and state anxiety as well as reducing pulse rate and increasing higher finger temperature (p = 0.05 to 0.001). In addition, significant differences were detected between the pretest and posttest measures for silence (p = 0.001). The results suggest that lento music is effective at anxiety reduction. This study provides evidence for nursing faculty and clinical educators to foster nursing students' mastering over the anxiety of examination by using lento music.

  16. Music intervention during daily weaning trials-A 6 day prospective randomized crossover trial.

    Science.gov (United States)

    Liang, Zhan; Ren, Dianxu; Choi, JiYeon; Happ, Mary Beth; Hravnak, Marylyn; Hoffman, Leslie A

    2016-12-01

    To examine the effect of patient-selected music intervention during daily weaning trials for patients on prolonged mechanical ventilation. Using a crossover repeated measures design, patients were randomized to music vs no music on the first intervention day. Provision of music was alternated for 6 days, resulting in 3 music and 3 no music days. During weaning trials on music days, data were obtained for 30min prior to music listening and continued for 60min while patients listened to selected music (total 90min). On no music days, data were collected for 90min. Outcome measures were heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), blood pressure (BP), dyspnea and anxiety assessed with a visual analog scale (VAS-D, VAS-A) and weaning duration (meanh per day on music and non-music days). Of 31 patients randomized, 23 completed the 6-day intervention. When comparisons were made between the 3 music and 3 no music days, there were significant decreases in RR and VAS-D and a significant increase in daily weaning duration on music days (pmusic days (pmusic during daily weaning trials is a simple, low-cost, potentially beneficial intervention for patients on prolonged mechanical ventilation. Further study is indicated to test ability of this intervention to promote weaning success and benefits earlier in the weaning process. Copyright © 2016 Elsevier Ltd. All rights reserved.

  17. Transcranial Direct Current Stimulation for Post-Concussion Syndrome: Study Protocol for a Randomized Crossover Trial

    Directory of Open Access Journals (Sweden)

    Robson Luis Oliveira de Amorim

    2017-05-01

    Full Text Available BackgroundMild traumatic brain injury (MTBI represents 70–80% of all treated brain injuries. A considerable proportion of MTBI patients experience post-concussion symptoms for a prolonged period after MTBI, and these symptoms are diagnosed as persistent post-concussion syndrome (PPCS. PPCS is defined as a range of physical, cognitive, and emotional symptoms. However, memory and executive dysfunction seems to be one of the most debilitating symptoms. Recently, non-invasive brain stimulation has been studied as a potential treatment method for traumatic brain injury (TBI patients. Therefore, our primary goal is to verify the effects of transcranial direct current stimulation (tDCS in patients with PPCS who demonstrate cognitive deficits in long-term episodic memory, working memory, and executive function following MTBI.Methods/designThis is a randomized crossover trial of patients with a history of MTBI with cognitive deficits in memory and executive function. Thirty adult patients will be randomized in a crossover manner to receive three weekly sessions of anodal tDCS (2 mA at left dorsolateral prefrontal cortex, left temporal cortex, and sham stimulation that will be performed at 7-day intervals (washout period. The clinical diagnosis of PPCS will be determined using the Rivermead Post-Concussion Symptoms Questionnaire. Patients who meet the inclusion criteria will be assessed with a neuropsychological evaluation. A new battery of computerized neuropsychological tests will be performed before and immediately after each stimulation. Statistical analysis will be performed to determine trends of cognitive improvement.DiscussionThere is paucity of studies regarding the use of tDCS in TBI patients, and although recent results showed controversial data regarding the effects of tDCS in such patients, we will address specifically patients with PPCS and MTBI and no brain abnormalities on CT scan other than subarachnoid hemorrhage. Moreover, due to

  18. Acute dark chocolate and cocoa ingestion and endothelial function: a randomized controlled crossover trial.

    Science.gov (United States)

    Faridi, Zubaida; Njike, Valentine Yanchou; Dutta, Suparna; Ali, Ather; Katz, David L

    2008-07-01

    Studies suggest cardioprotective benefits of dark chocolate containing cocoa. This study examines the acute effects of solid dark chocolate and liquid cocoa intake on endothelial function and blood pressure in overweight adults. Randomized, placebo-controlled, single-blind crossover trial of 45 healthy adults [mean age: 53 y; mean body mass index (in kg/m(2)): 30]. In phase 1, subjects were randomly assigned to consume a solid dark chocolate bar (containing 22 g cocoa powder) or a cocoa-free placebo bar (containing 0 g cocoa powder). In phase 2, subjects were randomly assigned to consume sugar-free cocoa (containing 22 g cocoa powder), sugared cocoa (containing 22 g cocoa powder), or a placebo (containing 0 g cocoa powder). Solid dark chocolate and liquid cocoa ingestion improved endothelial function (measured as flow-mediated dilatation) compared with placebo (dark chocolate: 4.3 +/- 3.4% compared with -1.8 +/- 3.3%; P cocoa: 5.7 +/- 2.6% and 2.0 +/- 1.8% compared with -1.5 +/- 2.8%; P cocoa compared with placebo (dark chocolate: systolic, -3.2 +/- 5.8 mm Hg compared with 2.7 +/- 6.6 mm Hg; P cocoa: systolic, -2.1 +/- 7.0 mm Hg compared with 3.2 +/- 5.6 mm Hg; P cocoa (5.7 +/- 2.6% compared with 2.0 +/- 1.8%; P cocoa improved endothelial function and lowered blood pressure in overweight adults. Sugar content may attenuate these effects, and sugar-free preparations may augment them.

  19. Simulating Negotiations in a Three-Way Civil War

    Science.gov (United States)

    Shaw, Carolyn M.

    2006-01-01

    This article examines a role play scenario in which students actively learn about the challenges of negotiation by taking on the roles of different factions and international mediators in a three-way civil war. Students gain a greater appreciation for the complexities of negotiations both in terms of outcomes and process, and they may begin to…

  20. Randomized Crossover Comparison of Personalized MPC and PID Control Algorithms for the Artificial Pancreas

    Science.gov (United States)

    Pinsker, Jordan E.; Lee, Joon Bok; Dassau, Eyal; Seborg, Dale E.; Bradley, Paige K.; Gondhalekar, Ravi; Bevier, Wendy C.; Huyett, Lauren; Zisser, Howard C.

    2016-01-01

    OBJECTIVE To evaluate two widely used control algorithms for an artificial pancreas (AP) under nonideal but comparable clinical conditions. RESEARCH DESIGN AND METHODS After a pilot safety and feasibility study (n = 10), closed-loop control (CLC) was evaluated in a randomized, crossover trial of 20 additional adults with type 1 diabetes. Personalized model predictive control (MPC) and proportional integral derivative (PID) algorithms were compared in supervised 27.5-h CLC sessions. Challenges included overnight control after a 65-g dinner, response to a 50-g breakfast, and response to an unannounced 65-g lunch. Boluses of announced dinner and breakfast meals were given at mealtime. The primary outcome was time in glucose range 70–180 mg/dL. RESULTS Mean time in range 70–180 mg/dL was greater for MPC than for PID (74.4 vs. 63.7%, P = 0.020). Mean glucose was also lower for MPC than PID during the entire trial duration (138 vs. 160 mg/dL, P = 0.012) and 5 h after the unannounced 65-g meal (181 vs. 220 mg/dL, P = 0.019). There was no significant difference in time with glucose PID control for the AP indicates that MPC performed particularly well, achieving nearly 75% time in the target range, including the unannounced meal. Although both forms of CLC provided safe and effective glucose management, MPC performed as well or better than PID in all metrics. PMID:27289127

  1. A randomized double-blind crossover study of phase-shift sound therapy for tinnitus.

    Science.gov (United States)

    Heijneman, Karin M; de Kleine, Emile; van Dijk, Pim

    2012-08-01

    The purpose of this study was to compare the efficacy of the treatment of tinnitus with a phase-shifting pure tone to that of the same tone treatment without phase shifting. A double-blind crossover randomized controlled trial. This study was conducted at the University Medical Center Groningen. Twenty-two patients with predominantly tonal tinnitus underwent both intervention and control treatments. Each treatment consisted of three 30-minute sessions in 1 week. The control treatment was identical to the intervention treatment, except that the stimulus was a pure tone without phase shifting. Questionnaires, tinnitus loudness match, and annoyance and loudness ratings were used to measure treatment effects. Pure-tone treatment and phase-shift treatment had no significant effect on tinnitus according to questionnaires (Tinnitus Handicap Index, Tinnitus Reaction Questionnaire, Hospital Anxiety and Depression Scale, and Maastricht Questionnaire), audiological matching procedures, and loudness and annoyance ratings of tinnitus. Furthermore, phase-shift treatment showed no additional significant improvement in comparison with pure-tone treatment. Changes in questionnaire scores due to pure-tone and the phase-shift treatment were correlated. On average across the group, both treatments failed to demonstrate a significant effect. Both treatments were beneficial for some patients. However, a positive effect was not demonstrated that could be attributed to the periodic shifting of the phase of the stimulus tone.

  2. 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.

  3. Topical Administration of Pirfenidone Increases Healing of Chronic Diabetic Foot Ulcers: A Randomized Crossover Study.

    Science.gov (United States)

    Janka-Zires, Marcela; Almeda-Valdes, Paloma; Uribe-Wiechers, Ana Cecilia; Juárez-Comboni, Sonia Citlali; López-Gutiérrez, Joel; Escobar-Jiménez, Jarod Jazek; Gómez-Pérez, Francisco J

    2016-01-01

    Only 30 percent of chronic diabetic foot ulcers heal after 20 weeks of standard treatment. Pirfenidone is a drug with biological, anti-inflammatory, and antifibrotic effects. The aim of this study was to evaluate the effect of topical pirfenidone added to conventional treatment in noninfected chronic diabetic foot ulcers. This was a randomized crossover study. Group 1 received topical pirfenidone plus conventional treatment for 8 weeks; after this period, they were switched to receive conventional treatment only for 8 more weeks. In group 2, the order of the treatments was the opposite. The end points were complete ulcer healing and size reduction. Final data were obtained from 35 ulcers in 24 patients. Fifty-two percent of ulcers treated with pirfenidone healed before 8 weeks versus 14.3% treated with conventional treatment only (P = 0.025). Between 8 and 16 weeks, 30.8% ulcers that received pirfenidone healed versus 0% with conventional treatment (P = 0.081). By week 8, the reduction in ulcer size was 100% [73-100] with pirfenidone versus 57.5% with conventional treatment [28.9-74] (P = 0.011). By week 16, the reduction was 93% [42.7-100] with pirfenidone and 21.8% [8-77.5] with conventional treatment (P = 0.050). The addition of topical pirfenidone to conventional treatment significantly improves the healing of chronic diabetic noninfected foot ulcers.

  4. Topical Administration of Pirfenidone Increases Healing of Chronic Diabetic Foot Ulcers: A Randomized Crossover Study

    Directory of Open Access Journals (Sweden)

    Marcela Janka-Zires

    2016-01-01

    Full Text Available Only 30 percent of chronic diabetic foot ulcers heal after 20 weeks of standard treatment. Pirfenidone is a drug with biological, anti-inflammatory, and antifibrotic effects. The aim of this study was to evaluate the effect of topical pirfenidone added to conventional treatment in noninfected chronic diabetic foot ulcers. This was a randomized crossover study. Group 1 received topical pirfenidone plus conventional treatment for 8 weeks; after this period, they were switched to receive conventional treatment only for 8 more weeks. In group 2, the order of the treatments was the opposite. The end points were complete ulcer healing and size reduction. Final data were obtained from 35 ulcers in 24 patients. Fifty-two percent of ulcers treated with pirfenidone healed before 8 weeks versus 14.3% treated with conventional treatment only (P=0.025. Between 8 and 16 weeks, 30.8% ulcers that received pirfenidone healed versus 0% with conventional treatment (P=0.081. By week 8, the reduction in ulcer size was 100% [73–100] with pirfenidone versus 57.5% with conventional treatment [28.9–74] (P=0.011. By week 16, the reduction was 93% [42.7–100] with pirfenidone and 21.8% [8–77.5] with conventional treatment (P=0.050. The addition of topical pirfenidone to conventional treatment significantly improves the healing of chronic diabetic noninfected foot ulcers.

  5. Video game playing increases food intake in adolescents: a randomized crossover study.

    Science.gov (United States)

    Chaput, Jean-Philippe; Visby, Trine; Nyby, Signe; Klingenberg, Lars; Gregersen, Nikolaj T; Tremblay, Angelo; Astrup, Arne; Sjödin, Anders

    2011-06-01

    Video game playing has been linked to obesity in many observational studies. However, the influence of this sedentary activity on food intake is unknown. The objective was to examine the acute effects of sedentary video game play on various components of energy balance. With the use of a randomized crossover design, 22 healthy, normal-weight, male adolescents (mean ± SD age: 16.7 ± 1.1 y) completed two 1-h experimental conditions, namely video game play and rest in a sitting position, followed by an ad libitum lunch. The endpoints were spontaneous food intake, energy expenditure, stress markers, appetite sensations, and profiles of appetite-related hormones. Heart rate, systolic and diastolic blood pressures, sympathetic tone, and mental workload were significantly higher during the video game play condition than during the resting condition (P video game play than during rest (mean increase over resting: 89 kJ; P video game play exceeded that measured after rest by 335 kJ (P video game play condition. The increase in food intake associated with video game play was observed without increased sensations of hunger and was not compensated for during the rest of the day. Finally, the profiles of glucose, insulin, cortisol, and ghrelin did not suggest an up-regulation of appetite during the video game play condition. A single session of video game play in healthy male adolescents is associated with an increased food intake, regardless of appetite sensations. The trial was registered at clinicaltrials.gov as NCT01013246.

  6. Effect of lavender aromatherapy on menopause hot flushing: A crossover randomized clinical trial.

    Science.gov (United States)

    Kazemzadeh, Rafat; Nikjou, Roya; Rostamnegad, Masoumeh; Norouzi, Hosein

    2016-09-01

    Flushing is generally considered to be the primary symptom of menopause and is typically the most common complaint in menopausal women. Although flushing poses no danger to a woman's health, it decreases the quality of life. Thus, the purpose of this study was to determine the effect of lavender aromatherapy on menopause flushing. This double-blinded crossover clinical trial included 100 menopausal women 45-55 years of age who were referred to various health centers in Ardabil, Iran in 2013-2014. Samples were blocked randomly and divided into two intervention (lavender) and control (diluted milk) groups. Lavender aroma was smelled for 20 minutes twice a day, over a 12-week period. Data were collected using a demographic questionnaire, and flushing numbers were duly recorded. Data analysis was performed by SPSS version 16 (SPSS Inc., Chicago, IL, USA) using the Chi-square and t test. The results of our investigation showed that both groups had no significant difference according to demographic characteristics (p > 0.05). Additionally, the flushing number significantly decreased in the intervention group than in the control group (p aromatherapy reduced menopause flushing. Given the impact of stress on flushing and the undesirable effects of menopause symptoms on the quality of life, it would appear that this simple, noninvasive, safe, and effective method can be used by menopausal women with noticeable benefits. Copyright © 2016. Published by Elsevier Taiwan LLC.

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

    Directory of Open Access Journals (Sweden)

    Nirjhar Dutta

    2014-06-01

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

  8. Does epicatechin contribute to the acute vascular function effects of dark chocolate? A randomized, crossover study.

    Science.gov (United States)

    Dower, James I; Geleijnse, Johanna M; Kroon, Paul A; Philo, Mark; Mensink, Marco; Kromhout, Daan; Hollman, Peter C H

    2016-11-01

    Cocoa, rich in flavan-3-ols, improves vascular function, but the contribution of specific flavan-3-ols is unknown. We compared the effects of pure epicatechin, a major cocoa flavan-3-ol, and chocolate. In a randomized crossover study, twenty healthy men (40-80 years) were supplemented with: (1) 70g dark chocolate (150 mg epicatechin) with placebo capsules; (2) pure epicatechin capsules (2 × 50 mg epicatechin) with 75g white chocolate; and (3) placebo capsules with 75 g white chocolate (0 mg epicatechin). Vascular function (flow-mediated dilation (FMD) and augmentation index (AIx)) were measured before and 2 hours after interventions. Epicatechin metabolites time-profiles were measured in blood to calculate the bioavailability. Pure epicatechin did not significantly improve FMD (+0.75%; p = 0.10) or AIx (-2.2%; p = 0.23) compared to placebo. Dark chocolate significantly improved FMD (+0.96%; p = 0.04) and AIx (-4.6%; p = 0.02). Differences in improvements in FMD (+ 0.21%; p = 0.65) or Aix (-2.4%; p = 0.20) between pure epicatechin and dark chocolate were not significant. The bioavailability of epicatechin did not differ between pure epicatechin and dark chocolate (p = 0.14). Despite differences in epicatechin dose, improvements in vascular function after pure epicatechin and chocolate were similar and the bioavailability did not differ, suggesting a role for epicatechin. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  9. Appropriate statistical methods were infrequently used in cluster-randomized crossover trials.

    Science.gov (United States)

    Arnup, Sarah J; Forbes, Andrew B; Kahan, Brennan C; Morgan, Katy E; McKenzie, Joanne E

    2016-06-01

    To assess the design and statistical methods used in cluster-randomized crossover (CRXO) trials. We undertook a systematic review of CRXO trials. Searches of MEDLINE, EMBASE, and CINAHL Plus; and citation searches of CRXO methodological articles were conducted to December 2014. We extracted data on design characteristics and statistical methods for sample size, data analysis, and handling of missing data. Ninety-one trials including 139 end point analyses met the inclusion criteria. Trials had a median of nine clusters [interquartile range (IQR), 4-21] and median cluster-period size of 30 individuals (IQR, 14-77); 58 (69%) trials had two periods, and 27 trials (30%) included the same individuals in all periods. A rationale for the design was reported in only 25 trials (27%). A sample size justification was provided in 53 (58%) trials. Only nine (10%) trials accounted appropriately for the design in their sample size calculation. Ten of the 12 cluster-level analyses used a method that accounted for the clustering and multiple-period aspects of the design. In contrast, only 4 of the 127 individual-level analyses used a potentially appropriate method. There is a need for improved application of appropriate analysis and sample size methods, and reporting, in CRXO trials. Copyright © 2015 Elsevier Inc. All rights reserved.

  10. Alkaline Peroxides Versus Sodium Hypochlorite for Removing Denture Biofilm: a Crossover Randomized Trial.

    Science.gov (United States)

    Peracini, Amanda; Regis, Rômulo Rocha; Souza, Raphael Freitas de; Pagnano, Valéria Oliveira; Silva, Cláudia Helena Lovato da; Paranhos, Helena de Freitas Oliveira

    2016-01-01

    This study evaluated the efficacy of cleanser solutions on denture biofilm removal by a crossover randomized clinical trial. Thirty two edentulous patients were instructed to brush their dentures (specific brush and liquid soap) three times a day (after breakfast, lunch and dinner) and to soak them (≥ 8 h) in: (C) control -water; (AP): alkaline peroxide; or (SH) 0.5% sodium hypochlorite. Each solution was used for 21 days (three cycles of 7 days). At the end of each cycle, the inner surfaces of maxillary dentures were disclosed (1% neutral red) and photographed (HX1 - Sony). Areas (total and stained biofilm) were measured (Image Tool software) and the percentage of biofilm calculated as the ratio between the area of the biofilm multiplied by 100 and total surface area of the internal base of the denture. Data were compared by means of generalized estimating equation (α=5%) and multiple comparisons (Bonferroni; α=1.67%). Immersion in SH reduced biofilm (%) (8.3 ± 13.3B) compared to C (18.2 ± 14.9A) and AP (18.2 ± 16.6A). The 0.5% sodium hypochlorite solution was the most efficacious for biofilm removal. Alkaline peroxides may not lead to further biofilm removal in patients with adequate denture maintenance habits.

  11. Auricular Acupuncture for Exam Anxiety in Medical Students—A Randomized Crossover Investigation

    Science.gov (United States)

    Klausenitz, Catharina; Hacker, Henriette; Hesse, Thomas; Kohlmann, Thomas; Endlich, Karlhans; Hahnenkamp, Klaus; Usichenko, Taras

    2016-01-01

    Auricular acupuncture (AA) is effective in the treatment of preoperative anxiety. The aim was to investigate whether AA can reduce exam anxiety as compared to placebo and no intervention. Forty-four medical students were randomized to receive AA, placebo, or no intervention in a crossover manner and subsequently completed three comparable oral anatomy exams with an interval of 1 month between the exams/interventions. AA was applied using indwelling fixed needles bilaterally at points MA-IC1, MA-TF1, MA-SC, MA-AT1 and MA-TG one day prior to each exam. Placebo needles were used as control. Levels of anxiety were measured using a visual analogue scale before and after each intervention as well as before each exam. Additional measures included the State-Trait-Anxiety Inventory, duration of sleep at night, blood pressure, heart rate and the extent of participant blinding. All included participants finished the study. Anxiety levels were reduced after AA and placebo intervention compared to baseline and the no intervention condition (p exam (p = 0.018). Participants were able to distinguish between AA and placebo intervention. Both AA and placebo interventions reduced exam anxiety in medical students. The superiority of AA over placebo may be due to insufficient blinding of participants. PMID:28033320

  12. The effects of alprazolam on tinnitus: a cross-over randomized clinical trial.

    Science.gov (United States)

    Jalali, Mir Mohammad; Kousha, Abdorrahim; Naghavi, Sayed Ebrahim; Soleimani, Robabeh; Banan, Rozbeh

    2009-11-01

    Tinnitus remains a phenomenon with an unknown pathophysiology and for which few therapeutic measures are available. To date there has been insufficient evidence to support the use of alprazolam in the treatment of tinnitus. We sought to evaluate the efficacy of alprazolam for relief of tinnitus. Thirty-six tinnitus sufferers participated in this cross-over, randomized, triple-blind, placebo-controlled trial. Inclusion criteria included patients between ages 21 and 65, with a complaint of non-pulsatile tinnitus of more than 1 year duration. Patients with depressive or anxiety disorders were excluded, as were those using hearing aids. Participants received alprazolam 1.5 mg daily versus placebo in each period. Primary outcome variables included the Tinnitus Handicap Inventory (THI), a Visual Analog Scale (VAS), and tinnitus loudness. Thirty patients completed the study. The average age of patients was 47.58+/-7.65 years. Alprazolam in comparison with placebo did not result in statistically significantly greater relief in THI score and tinnitus loudness. There was a significant improvement in VAS score in the alprazolam group compared with the placebo group (palprazolam did not improve the THI score or sensation level of loudness significantly, it has a desirable effect on VAS. Further work is needed to determine the beneficial effects of alprazolam in distressed or depressed patients.

  13. Physical exercise through mountain hiking in high-risk suicide patients. A randomized crossover trial.

    Science.gov (United States)

    Sturm, J; Plöderl, M; Fartacek, C; Kralovec, K; Neunhäuserer, D; Niederseer, D; Hitzl, W; Niebauer, J; Schiepek, G; Fartacek, R

    2012-12-01

    The following crossover pilot study attempts to prove the effects of endurance training through mountain hiking in high-risk suicide patients. Participants (n = 20) having attempted suicide at least once and clinically diagnosed with hopelessness were randomly distributed among two groups. Group 1 (n = 10) began with a 9-week hiking phase followed by a 9-week control phase. Group 2 (n = 10) worked vice versa. Assessments included the Beck Hopelessness Scale (BHS), Beck Depression Inventory (BDI), Beck Scale of Suicide Ideation (BSI), and maximum physical endurance. Ten participants of Group 1 and seven participants of Group 2 completed the study. A comparison between conditions showed that, in the hiking phase, there was a significant decrease in hopelessness (P suicide ideation (P = 0.25, d = -0.29). However, within the hiking phase, there was a significant decrease in suicide ideation (P = 0.005, d = -0.79). The results suggest that a group experience of regular monitored mountain hiking, organized as an add-on therapy to usual care, is associated with an improvement of hopelessness, depression, and suicide ideation in patients suffering from high-level suicide risk. © 2012 John Wiley & Sons A/S.

  14. Auricular Acupuncture for Exam Anxiety in Medical Students-A Randomized Crossover Investigation.

    Directory of Open Access Journals (Sweden)

    Catharina Klausenitz

    Full Text Available Auricular acupuncture (AA is effective in the treatment of preoperative anxiety. The aim was to investigate whether AA can reduce exam anxiety as compared to placebo and no intervention. Forty-four medical students were randomized to receive AA, placebo, or no intervention in a crossover manner and subsequently completed three comparable oral anatomy exams with an interval of 1 month between the exams/interventions. AA was applied using indwelling fixed needles bilaterally at points MA-IC1, MA-TF1, MA-SC, MA-AT1 and MA-TG one day prior to each exam. Placebo needles were used as control. Levels of anxiety were measured using a visual analogue scale before and after each intervention as well as before each exam. Additional measures included the State-Trait-Anxiety Inventory, duration of sleep at night, blood pressure, heart rate and the extent of participant blinding. All included participants finished the study. Anxiety levels were reduced after AA and placebo intervention compared to baseline and the no intervention condition (p < 0.003. AA was better at reducing anxiety than placebo in the evening before the exam (p = 0.018. Participants were able to distinguish between AA and placebo intervention. Both AA and placebo interventions reduced exam anxiety in medical students. The superiority of AA over placebo may be due to insufficient blinding of participants.

  15. Auricular Acupuncture for Exam Anxiety in Medical Students-A Randomized Crossover Investigation.

    Science.gov (United States)

    Klausenitz, Catharina; Hacker, Henriette; Hesse, Thomas; Kohlmann, Thomas; Endlich, Karlhans; Hahnenkamp, Klaus; Usichenko, Taras

    2016-01-01

    Auricular acupuncture (AA) is effective in the treatment of preoperative anxiety. The aim was to investigate whether AA can reduce exam anxiety as compared to placebo and no intervention. Forty-four medical students were randomized to receive AA, placebo, or no intervention in a crossover manner and subsequently completed three comparable oral anatomy exams with an interval of 1 month between the exams/interventions. AA was applied using indwelling fixed needles bilaterally at points MA-IC1, MA-TF1, MA-SC, MA-AT1 and MA-TG one day prior to each exam. Placebo needles were used as control. Levels of anxiety were measured using a visual analogue scale before and after each intervention as well as before each exam. Additional measures included the State-Trait-Anxiety Inventory, duration of sleep at night, blood pressure, heart rate and the extent of participant blinding. All included participants finished the study. Anxiety levels were reduced after AA and placebo intervention compared to baseline and the no intervention condition (p anxiety than placebo in the evening before the exam (p = 0.018). Participants were able to distinguish between AA and placebo intervention. Both AA and placebo interventions reduced exam anxiety in medical students. The superiority of AA over placebo may be due to insufficient blinding of participants.

  16. Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study

    Directory of Open Access Journals (Sweden)

    Lavinia Fiorentino

    2009-12-01

    Full Text Available Lavinia Fiorentino1, John R McQuaid2, Lianqi Liu3, Loki Natarajan4, Feng He4, Monique Cornejo3, Susan Lawton3, Barbara A Parker6, Georgia R Sadler5, Sonia Ancoli-Israel31Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Behavior, University of California, Los Angeles, CA, USA; 2Department of Psychiatry, University of California, San Francisco, CA, USA; 3Department of Psychiatry, 4Department of Family and Preventive Medicine, 5Department of Surgery, University of California, San Diego School of Medicine, La Jolla, CA, USA; 6Moores UCSD Cancer Center, La Jolla, CA, USAPurpose: Estimates of insomnia in breast cancer patients are high, with reports of poor sleep lasting years after completion of cancer treatment. This randomized controlled crossover pilot study looked at the effects of individual cognitive behavioral therapy for insomnia (IND-CBT-I on sleep in breast cancer survivors.Patients and methods: Twenty-one participants were randomly assigned to either a treatment group (six weekly IND-CBT-I sessions followed by six weeks of follow up or a delayed treatment control group (no treatment for six weeks followed by six weekly IND-CBT-I sessions. Of these, 14 participants completed the pilot study (six in the treatment group and eight in the delayed treatment control group.Results: Self-rated insomnia was significantly improved in the treatment group compared to the waiting period in the delayed treatment control group. The pooled pre–post-IND-CBT-I analyses revealed improvements in self-rated insomnia, sleep quality, and objective measures of sleep.Conclusions: These preliminary results suggest that IND-CBT-I is appropriate for improving sleep in breast cancer survivors. Individual therapy in a clinic or private practice may be a more practical option for this population as it is more easily accessed and readily available in an outpatient setting.Keywords: insomnia, breast cancer, cognitive behavioral therapy

  17. Double-blind, randomized, controlled, crossover trial of pregabalin for neurogenic claudication.

    Science.gov (United States)

    Markman, John D; Frazer, Maria E; Rast, Shirley A; McDermott, Michael P; Gewandter, Jennifer S; Chowdhry, Amit K; Czerniecka, Kate; Pilcher, Webster H; Simon, Lee S; Dworkin, Robert H

    2015-01-20

    To test the effects of pregabalin on the induction of neurogenic claudication. This study was a randomized, double-blind, active placebo-controlled, 2-period, crossover trial. Twenty-nine subjects were randomized to receive pregabalin followed by active placebo (i.e., diphenhydramine) or active placebo followed by pregabalin. Each treatment period lasted 10 days, including a 2-step titration. Periods were separated by a 10-day washout period, including a 3-day taper phase after the first period. The primary outcome variable was the time to first moderate pain symptom (Numeric Rating Scale score ≥4) during a 15-minute treadmill test (Tfirst). Secondary outcome measures included pain intensity at rest, pain intensity at the end of the treadmill test, distance walked, and validated self-report measures of pain and functional limitation including the Roland-Morris Disability Questionnaire, modified Brief Pain Inventory-Short Form, Oswestry Disability Index, and Swiss Spinal Stenosis Questionnaire. No significant difference was found between pregabalin and active placebo for the time to first moderate pain symptom (difference in median Tfirst = -1.08 [95% confidence interval -2.25 to 0.08], p = 0.61). In addition, none of the secondary outcome measures of pain or functional limitation were significantly improved by pregabalin compared with active placebo. Pregabalin was not more effective than active placebo in reducing painful symptoms or functional limitations in patients with neurogenic claudication associated with lumbar spinal stenosis. This study provides Class I evidence that for patients with neurogenic claudication, compared with diphenhydramine, pregabalin does not increase the time to moderate pain during a treadmill test. © 2014 American Academy of Neurology.

  18. Differential impact of the cheese matrix on the postprandial lipid response: a randomized, crossover, controlled trial.

    Science.gov (United States)

    Drouin-Chartier, Jean-Philippe; Tremblay, André J; Maltais-Giguère, Julie; Charest, Amélie; Guinot, Léa; Rioux, Laurie-Eve; Labrie, Steve; Britten, Michel; Lamarche, Benoît; Turgeon, Sylvie L; Couture, Patrick

    2017-12-01

    Background: In a simulated gastrointestinal environment, the cheese matrix modulates dairy fat digestion. However, to our knowledge, the impact of the cheese matrix on postprandial lipemia in humans has not yet been evaluated.Objective: In healthy subjects, we compared the impact of dairy fat provided from firm cheese, soft cream cheese, and butter on the postprandial response at 4 h and on the incremental area under the curve (iAUC) of plasma triglycerides.Design: Forty-three healthy subjects were recruited to this randomized, crossover, controlled trial. In random order at intervals of 14 d and after a 12-h fast, subjects ingested 33 g fat from a firm cheese (young cheddar), a soft cream cheese (cream cheese), or butter (control) incorporated into standardized meals that were matched for macronutrient content. Plasma concentrations of triglycerides were measured immediately before the meal and 2, 4, 6, and 8 h after the meal.Results: Cheddar cheese, cream cheese, and butter induced similar increases in triglyceride concentrations at 4 h (change from baseline: +59%, +59%, and +62%, respectively; P = 0.9). No difference in the triglyceride iAUC0-8 h (P-meal = 0.9) was observed between the 3 meals. However, at 2 h, the triglyceride response caused by the cream cheese (change from baseline: +44%) was significantly greater than that induced by butter (change from baseline: +24%; P = 0.002) and cheddar cheese (change from baseline: +16%; P = 0.0004). At 6 h, the triglyceride response induced by cream cheese was significantly attenuated compared with that induced by cheddar cheese (change from baseline: +14% compared with +42%; P = 0.0004).Conclusion: This study demonstrates that the cheese matrix modulates the impact of dairy fat on postprandial lipemia in healthy subjects. This trial was registered at clinicaltrials.gov as NCT02623790. © 2017 American Society for Nutrition.

  19. Effect of sensory stimuli on restless legs syndrome: a randomized crossover study.

    Science.gov (United States)

    Rozeman, Anouk D; Ottolini, Truus; Grootendorst, Diana C; Vogels, Oscar J M; Rijsman, Roselyne M

    2014-08-15

    A variety of sensory stimuli relieve restless legs syndrome symptoms. Because systematic evaluations of sensory stimulation in restless legs syndrome are largely lacking, we performed a randomized crossover study to evaluate the effect of external sensory stimulation on restless legs syndrome symptoms. Eighteen patients underwent 3 consecutive suggestive immobilization tests with the order of the following 3 conditions randomly assigned: no electrical stimulation (condition 1), tactile and proprioceptive sensory stimulation (condition 2), and tactile sensory stimulation only (condition 3). Restless legs syndrome symptoms were quantified by visual analog scales, and periodic leg movements during wake were measured. Baseline visual analogue scale score was 4.5 (range 0-60) in condition 1, 10.5 (range 0-96) in condition 2, and 8.5 in condition 3 (p = 0.21). There was a tendency towards a higher maximum visual analogue scale score and visual analogue scale score at the end of the suggested immobilization test in the conditions with tactile sensory stimulation, though not significant (p = 0.74 and p = 0.29, respectively). Fifteen patients suffered from periodic leg movements during wake. Median indices were 18 (range 0-145) in condition 1, 26 (range 0-190) in condition 2, and 49 (range 0-228) in condition 3 (p = 0.76). We found a tendency towards less leg discomfort in the conditions in which an external sensory input was applied. This potential benefit of sensory stimuli on restless legs syndrome severity merits further investigation as this could open new ways towards a better pathophysiological understanding and non-pharmacological treatments.

  20. Handheld vs. laptop computers for electronic data collection in clinical research: a crossover randomized trial.

    Science.gov (United States)

    Haller, Guy; Haller, Dagmar M; Courvoisier, Delphine S; Lovis, Christian

    2009-01-01

    To compare users' speed, number of entry errors and satisfaction in using two current devices for electronic data collection in clinical research: handheld and laptop computers. The authors performed a randomized cross-over trial using 160 different paper-based questionnaires and representing altogether 45,440 variables. Four data coders were instructed to record, according to a random predefined and equally balanced sequence, the content of these questionnaires either on a laptop or on a handheld computer. Instructions on the kind of device to be used were provided to data-coders in individual sealed and opaque envelopes. Study conditions were controlled and the data entry process performed in a quiet environment. The authors compared the duration of the data recording process, the number of errors and users' satisfaction with the two devices. The authors divided errors into two separate categories, typing and missing data errors. The original paper-based questionnaire was used as a gold-standard. The overall duration of the recording process was significantly reduced (2.0 versus 3.3 min) when data were recorded on the laptop computer (p laptop compared to 8.4 per 1,000 with the handheld computer (p laptop was used (p laptop easier, faster and more satisfying to use than the handheld computer. Despite the increasing use of handheld computers for electronic data collection in clinical research, these devices should be used with caution. They double the duration of the data entry process and significantly increase the risk of typing errors and missing data. This may become a particularly crucial issue in studies where these devices are provided to patients or healthcare workers, unfamiliar with computer technologies, for self-reporting or research data collection processes.

  1. Test-enhanced web-based learning: optimizing the number of questions (a randomized crossover trial).

    Science.gov (United States)

    Cook, David A; Thompson, Warren G; Thomas, Kris G

    2014-01-01

    Questions enhance learning in Web-based courses, but preliminary evidence suggests that too many questions may interfere with learning. The authors sought to determine how varying the number of self-assessment questions affects knowledge outcomes in a Web-based course. The authors conducted a randomized crossover trial in one internal medicine and one family medicine residency program between January 2009 and July 2010. Eight Web-based modules on ambulatory medicine topics were developed, with varying numbers of self-assessment questions (0, 1, 5, 10, or 15). Participants completed modules in four different formats each year, with sequence randomly assigned. Participants completed a pretest for half their modules. Outcomes included knowledge, completion time, and module ratings. One hundred eighty residents provided data. The mean (standard error) percent correct knowledge score was 53.2 (0.8) for pretests and 73.7 (0.5) for posttests. In repeated-measures analysis pooling all data, mean posttest knowledge scores were highest for the 10- and 15-question formats (75.7 [1.1] and 74.4 [1.0], respectively) and lower for 0-, 1-, and 5-question formats (73.1 [1.3], 72.9 [1.0], and 72.8 [1.5], respectively); P = .04 for differences across all modules. Modules with more questions generally took longer to complete and were rated higher, although differences were small. Residents most often identified 10 questions as ideal. Posttest knowledge scores were higher for modules that included a pretest (75.4 [0.9] versus 72.2 [0.9]; P = .0002). Increasing the number of self-assessment questions improves learning until a plateau beyond which additional questions do not add value.

  2. How to deal with morning bad breath: A randomized, crossover clinical trial

    Directory of Open Access Journals (Sweden)

    Jeronimo M Oliveira-Neto

    2013-01-01

    Full Text Available Context: The absence of a protocol for the treatment of halitosis has led us to compare mouthrinses with mechanical oral hygiene procedures for treating morning breath by employing a hand-held sulfide monitor. Aims: To compare the efficacy of five modalities of treatment for controlling morning halitosis in subjects with no dental or periodontal disease. Settings and Design: This is a five-period, randomized, crossover clinical trial. Materials and Methods: Twenty volunteers were randomly assigned to the trial. Testing involved the use of a conventional tongue scraper, a tongue scraper joined to the back of a toothbrush′s head, two mouthrinses (0.05% cetylpyridinium chloride and 0.12% chlorhexidine digluconate and a soft-bristled toothbrush and fluoride toothpaste for practicing oral hygiene. Statistical Analysis Used: Data analysis was performed using SPSS version 17 for Windows and NCSS 2007 software (P < 0.05. The products and the periods were compared with each other using the Friedman′s test. When significant differences (P < 0.05 were determined, the products and periods were compared in pairs by using the Wilcoxon′s test and by adjusting the original significance level (0.05 for multiple comparisons by using the Bonferroni′s method. Results: The toothbrush′s tongue scraper was able to significantly reduce bad breath for up to 2 h. Chlorhexidine reduced bad breath only at the end of the second hour, an effect that lasted for 3 h. Conclusions: Mechanical tongue cleaning was able to immediately reduce bad breath for a short period, whereas chlorhexidine and mechanical oral hygiene reduced bad breath for longer periods, achieving the best results against morning breath.

  3. A randomized single blind crossover trial comparing leather and commercial wrist splints for treating chronic wrist pain in adults

    OpenAIRE

    Thiele, Jill; Nimmo, Rachel; Rowell, Wendy; Quinn, Stephen; Jones, Graeme

    2009-01-01

    Abstract Background To compare the effectiveness of a custom-made leather wrist splint (LS) with a commercially available fabric splint (FS) in adults with chronic wrist pain. Methods Participants (N = 25, mean age = 54) were randomly assigned to treatment order in a 2-phase crossover trial. Splints were worn for 2 weeks, separated by a one-week washout period. Outcomes were assessed at baseline and after each splint phase using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN), the ...

  4. Efficacy of methylphenidate in children with attention-deficit hyperactivity disorder and learning disabilities: a randomized crossover trial

    OpenAIRE

    Grizenko, Natalie; Bhat, Mamatha; Schwartz, George; Ter-Stepanian, Marina; Joober, Ridha

    2006-01-01

    Objective: To determine whether children with attention-deficit hyperactivity disorder (ADHD) and learning disabilities respond differently to methylphenidate (MPH) compared with children with ADHD only. Methods: We conducted a prospective, double-blind, placebo-controlled, randomized, 2-week crossover trial of MPH, during which response to MPH was assessed. Learning ability was appraised using the Wide Range Achievement Test, Revised (WRAT-R), for English-speaking students and the Test de re...

  5. The Effects of Experimentally Manipulated Social Status on Acute Eating Behavior: A Randomized, Crossover Pilot Study

    Science.gov (United States)

    Cardel, MI; Johnson, SL; Beck, J; Dhurandhar, E; Keita, AD; Tomczik, AC; Pavela, G; Huo, T; Janicke, DM; Muller, K; Piff, PK; Peters, JC; Hill, JO; Allison, DB

    2016-01-01

    Both subjective and objectively measured social status has been associated with multiple health outcomes, including weight status, but the mechanism for this relationship remains unclear. Experimental studies may help identify the causal mechanisms underlying low social standing as a pathway for obesity. Our objective was to investigate the effects of experimentally manipulated social status on ad libitum acute dietary intakes and stress-related outcomes as potential mechanisms relating social status and weight. This was a pilot feasibility, randomized, crossover study in Hispanic young adults (n=9; age 19–25; 67% female; BMI ≥18.5 and ≤30 kg/m2). At visit 1, participants consumed a standardized breakfast and were randomized to a high social status position (HIGH) or low social status position (LOW) in a rigged game of Monopoly™. The rules for the game differed substantially in terms of degree of ‘privilege’ depending on randomization to HIGH or LOW. Following Monopoly™, participants were given an ad libitum buffet meal and energy intakes (kcal) were estimated by pre- and post-weighing foods consumed. Stress-related markers were measured at baseline, after the game of Monopoly™, and after lunch. Visit 2 used the same standardized protocol; however, participants were exposed to the opposite social status condition. When compared to HIGH, participants in LOW consumed 130 more calories (p=0.07) and a significantly higher proportion of their daily calorie needs in the ad libitum buffet meal (39% in LOW versus 31% in HIGH; p=0.04). In LOW, participants reported decreased feelings of pride and powerfulness following Monopoly™ (p=0.05) and after their lunch meal (p=0.08). Relative to HIGH, participants in LOW demonstrated higher heart rates following Monopoly™ (p=0.06), but this relationship was not significant once lunch was consumed (p=0.31). Our pilot data suggest a possible causal relationship between experimentally manipulated low social status

  6. Language-specific strategy for programming hearing aids - A double-blind randomized controlled crossover study.

    Science.gov (United States)

    Matsumoto, Nozomu; Suzuki, Nobuyoshi; Iwasaki, Satoshi; Ishikawa, Kazuha; Tsukiji, Hiroki; Higashino, Yoshie; Tabuki, Tomoko; Nakagawa, Takashi

    2017-11-17

    Voice-aligned compression (VAC) is a method used in Oticon's hearing aids to provide more comfortable hearing without sacrificing speech discrimination. The complex, non-linear compression curve for the VAC strategy is designed based on the frequency profile of certain spoken Western languages. We hypothesized that hearing aids could be further customized for Japanese-speaking users by modifying the compression curve using the frequency profile of spoken Japanese. A double-blind randomized controlled crossover study was performed to determine whether or not Oticon's modified amplification strategy (VAC-J) provides subjectively preferable hearing aids for Japanese-speaking hearing aid users compared to the same company's original amplification strategy (VAC). The participants were randomized to two groups. The VAC-first group received a pair of hearing aids programmed using the VAC strategy and wore them for three weeks, and then received a pair of hearing aids programmed using VAC-J strategy and wore them for three weeks. The VAC-J-first group underwent the same study, but they received hearing aids in the reverse sequence. A Speech, Spatial and Qualities (SSQ) questionnaire was administered before beginning to use the hearing aids, at the end of using the first pair of hearing aids, and at the end of using the second pair of hearing aids. Twenty-five participants that met the inclusion/exclusion criteria from January 1 to October 31, 2016, were randomized to two groups. Twenty-two participants completed the study. There were no statistically significant differences in the increment of SSQ scores between the participants when using the VAC- or the VAC-J-programmed hearing aids. However, participants preferred the VAC-J strategy to the VAC strategy at the end of the study, and this difference was statistically significant. Japanese-speaking hearing aid users preferred using hearing aids that were fitted with the VAC-J strategy. Our results show that the VAC strategy

  7. Eating dark and milk chocolate: a randomized crossover study of effects on appetite and energy intake.

    Science.gov (United States)

    Sørensen, L B; Astrup, A

    2011-12-05

    To compare the effect of dark and milk chocolate on appetite sensations and energy intake at an ad libitum test meal in healthy, normal-weight men. A total of 16 young, healthy, normal-weight men participated in a randomized, crossover study. Test meals were 100 g of either milk (2285 kJ) or dark chocolate (2502 kJ). Visual-analogue scales were used to record appetite sensations before and after the test meal was consumed and subsequently every 30 min for 5 h. An ad libitum meal was served 2 h after the test meal had been consumed. The participants felt more satiated, less hungry, and had lower ratings of prospective food consumption after consumption of the dark chocolate than after the milk chocolate. Ratings of the desire to eat something sweet, fatty or savoury were all lower after consumption of the dark chocolate. Energy intake at the ad libitum meal was 17% lower after consumption of the dark chocolate than after the milk chocolate (P=0.002). If the energy provided by the chocolate is included in the calculation, the energy intake after consumption of the dark chocolate was still 8% lower than after the milk chocolate (P=0.01). The dark chocolate load resulted in an overall energy difference of -584 kJ (95% confidence interval (-1027;-141)) during the test period. In the present study, dark chocolate promotes satiety, lowers the desire to eat something sweet, and suppresses energy intake compared with milk chocolate.

  8. Spa therapy adjunct to pharmacotherapy is beneficial in rheumatoid arthritis: a crossover randomized controlled trial

    Science.gov (United States)

    Karagülle, Mine; Kardeş, Sinan; Dişçi, Rian; Karagülle, Müfit Zeki

    2017-09-01

    This study aims to investigate whether 2-week spa therapy, as an adjunct to usual pharmacological therapy, has any beneficial effect in patients with rheumatoid arthritis (RA). In this single-blind crossover study, 50 patients were randomly assigned in a 1:1 manner to receive usual pharmacological therapy plus 2-week spa therapy or usual pharmacological therapy alone (period 1.6 months); after a 9-month washout, patients were crossed over to the opposite assignment (period 2.6 months). Spa therapy program included a daily saline balneotherapy session at 36-37 °C for 20 min except Sundays. The clinical outcomes were evaluated at baseline, after spa therapy (2 weeks) and 3 and 6 months after the spa therapy in both period and were pain (Visual Analogue Scale (VAS)), patient and physician global assessments (VAS), Health Assessment Questionnaire (HAQ), and Disease Activity Score (DAS28). Spa therapy was superior to control therapy in improving all the assessed clinical outcomes at the end of the spa therapy. This superiority persisted significantly in physician global assessment (p = 0.010) and with a trend in favor of spa group in patient global assessment (p = 0.058), function (p = 0.092), and disease activity (p = 0.098) at 3 months. Statistically significant improvements were found in spa therapy compared to control in disease activity (p = 0.006) and patient (p = 0.020) and physician global (p = 0.011) assessments, and a trend toward improvements in pain (p = 0.069) and swollen joints (p = 0.070) at 6 months. A 2-week spa therapy adjunct to usual pharmacological therapy provided beneficial clinical effects compared to usual pharmacological therapy alone, in RA patients treated with traditional disease-modifying antirheumatic drugs. These beneficial effects may last for 6 months.

  9. Docosahexaenoic acid-enriched canola oil increases adiponectin concentrations: a randomized crossover controlled intervention trial.

    Science.gov (United States)

    Baril-Gravel, L; Labonté, M-E; Couture, P; Vohl, M-C; Charest, A; Guay, V; Jenkins, D A; Connelly, P W; West, S; Kris-Etherton, P M; Jones, P J; Fleming, J A; Lamarche, B

    2015-01-01

    Little is known about the effect of various dietary fatty acids on pro- and anti-inflammatory processes. We investigated the effect of 5 oils containing various amounts of alpha-linolenic acid (ALA), linoleic acid (LA), oleic acid (OA) and docosahexaenoic acid (DHA) on plasma inflammatory biomarkers and expression levels of key inflammatory genes and transcription factors in whole blood cells. In a randomized, crossover controlled nutrition intervention, 114 adult men and women with abdominal obesity and at least one other criterion for the metabolic syndrome consumed 5 experimental isoenergetic diets for 4 weeks each, separated by 4-week washout periods. Each diet provided 60 g/3000 kcal of different oils: 1) control corn/safflower oil blend (CornSaff; LA-rich), 2) flax/safflower oil blend (FlaxSaff; ALA-rich), 3) conventional canola oil (Canola; OA-rich), 4) high oleic canola oil (CanolaOleic; highest OA content), 5) DHA-enriched high oleic canola oil (CanolaDHA; OA- and DHA-rich). Gene expression in whole blood cells was assessed in a subset of 62 subjects. CanolaDHA increased plasma adiponectin concentrations compared with the control CornSaff oil treatment (+4.5%, P = 0.04) and FlaxSaff (+6.9%, P = 0.0008). CanolaDHA also reduced relative expression levels of interleukin (IL)1B compared with CornSaff and Canola (-11% and -13%, respectively, both P = 0.03). High-sensitivity C-reactive protein concentrations were lower after Canola than after FlaxSaff (-17.8%, P = 0.047). DHA-enriched canola oil exerts anti-inflammatory effects compared with polyunsaturated fatty acids from plant sources. Copyright © 2014 Elsevier B.V. All rights reserved.

  10. Mandibular advancement appliances for sleep-disordered breathing in children: A randomized crossover clinical trial.

    Science.gov (United States)

    Idris, Ghassan; Galland, Barbara; Robertson, Christopher John; Gray, Andrew; Farella, Mauro

    2018-01-29

    To test the short-term effectiveness of a mandibular advancement splint (MAS) for the management of sleep-disordered breathing (SDB) in children. Eighteen SDB children were enrolled in a crossover randomized clinical trial and assigned to a treatment sequence starting either with an Active or a Sham MAS. Each appliance was worn for three weeks and treatment periods were separated by a two-week washout. Home-based polysomnographic data were collected before and after each treatment period. In addition, blood samples were collected at the end of each treatment period to assess serum levels of insulin-like growth factor-1 (IGF-1). The apnea-hypopnea index (AHI) and snoring time represented the main outcome variables. Secondary outcomes included IGF-1 levels, and questionnaire scores for quality of life and behavior. Compared to the Sham MAS, the wearing of the Active MAS resulted in a significant reduction in overall AHI (-37%; 95% CI = 15-53%; p = 0.002) and supine AHI (-4.1 events per hour; 95% CI = 1.8-6.4; p < 0.001). Mean snoring time per night was shorter with the Active MAS than with the Sham MAS (-46.3 min; 95% CI = 14.5-78.1; p = 0.004). Wearing of the Active MAS improved the ratings of quality of life and behavior (P ≤ 0.028), but there was no evidence that it influenced IGF-1 levels (P = 0.172). Wearing an Active MAS overnight, over a short period can be beneficial for SDB children, resulting in a clinically relevant reduction of supine AHI. Copyright © 2018 Elsevier Ltd. All rights reserved.

  11. (Ab)normal saline and physiological Hartmann's solution: a randomized double-blind crossover study.

    Science.gov (United States)

    Reid, Fiona; Lobo, Dileep N; Williams, Robert N; Rowlands, Brian J; Allison, Simon P

    2003-01-01

    In this double-blind crossover study, the effects of bolus infusions of 0.9% saline (NaCl) and Hartmann's solution on serum albumin, haematocrit and serum and urinary biochemistry were compared in healthy subjects. Nine young adult male volunteers received 2-litre intravenous infusions of 0.9% saline and Hartmann's solution on separate occasions, in random order, each over 1 h. Body weight, haematocrit and serum biochemistry were measured pre-infusion and at 1 h intervals for 6 h. Biochemical analysis was performed on pooled post-infusion urine. Blood and plasma volume expansion, estimated by dilutional effects on haematocrit and serum albumin, were greater and more sustained after saline than after Hartmann's solution (P Hartmann's solution. Subjects voided more urine (median: 1,000 compared with 450 ml) of higher sodium content (median: 122 compared with 73 mmol) after Hartmann's than after saline (both P =0.049), despite the greater sodium content of the latter. The time to first micturition was less after Hartmann's than after saline (median: 70 compared with 185 min; P =0.008). There were no significant differences between the effects of the two solutions on serum sodium, potassium, urea or osmolality. After saline, all subjects developed hyperchloraemia (>105 mmol/l), which was sustained for >6 h, while serum chloride concentrations remained normal after Hartmann's (P Hartmann's solution, due possibly to the more physiological [Na(+)]/[Cl(-)] ratio in Hartmann's solution (1.18:1) than in saline (1:1) and to the hyperchloraemia caused by saline.

  12. Randomized controlled crossover trial of a new oscillatory device as add-on therapy for COPD.

    Science.gov (United States)

    Fridlender, Zvi G; Arish, Nissim; Laxer, Uri; Berkman, Neville; Leibovitz, Allon; Fink, Gershon; Breuer, Raphael

    2012-12-01

    A new oscillatory device administers predetermined pressure oscillation sequences into the chest cavity over inhaled/exhaled air streams at low positive pressure. We assessed device safety and effect on 6MW performance, pulmonary function, and health-related quality-of-life (HRQOL) in moderate-to-very severe COPD in a randomized, double-blind, controlled, crossover study. Outcomes with an oscillatory device (Pulsehaler(TM), Respinova Ltd, Herzliya, Israel) and a "muted" sham device (control) of identical appearance that delivered continuous positive air pressure were compared in two groups receiving opposite treatment sequences: 2-week oscillatory device/control, 2-week washout, 2-week control/oscillatory device, 2-week washout. The clinical trial was registered ( www.clinicaltrials.gov , NCT00821418) and approved by the Hadassah-Hebrew University Medical Center Institutional Review Board (08-608). All participants signed informed consent; 22 patients completed the study with no marked differences in COPD exacerbations or side effects. A total of 91% of patients treated with the oscillatory device had a clinically significant improvement (increase >40 m) in 6MW performance. The 6MW distance with the oscillatory device increased significantly after 1 week of treatment (51.6 ± 7.6 m, +13.5 ± 2.3%, p device was significantly greater (p device but not with control. HRQL improved markedly (≥1 point) for dyspnea and mastery with the oscillatory device (p = 0.02) but not control. Treatment with a new oscillatory device appears to be safe, and to improve 6MW performance, pulmonary function, and HRQL in COPD. Further evaluation is warranted.

  13. Eating dark and milk chocolate: a randomized crossover study of effects on appetite and energy intake

    Science.gov (United States)

    Sørensen, L B; Astrup, A

    2011-01-01

    Objective: To compare the effect of dark and milk chocolate on appetite sensations and energy intake at an ad libitum test meal in healthy, normal-weight men. Subjects/methods: A total of 16 young, healthy, normal-weight men participated in a randomized, crossover study. Test meals were 100 g of either milk (2285 kJ) or dark chocolate (2502 kJ). Visual-analogue scales were used to record appetite sensations before and after the test meal was consumed and subsequently every 30 min for 5 h. An ad libitum meal was served 2 h after the test meal had been consumed. Results: The participants felt more satiated, less hungry, and had lower ratings of prospective food consumption after consumption of the dark chocolate than after the milk chocolate. Ratings of the desire to eat something sweet, fatty or savoury were all lower after consumption of the dark chocolate. Energy intake at the ad libitum meal was 17% lower after consumption of the dark chocolate than after the milk chocolate (P=0.002). If the energy provided by the chocolate is included in the calculation, the energy intake after consumption of the dark chocolate was still 8% lower than after the milk chocolate (P=0.01). The dark chocolate load resulted in an overall energy difference of −584 kJ (95% confidence interval (−1027;−141)) during the test period. Conclusion: In the present study, dark chocolate promotes satiety, lowers the desire to eat something sweet, and suppresses energy intake compared with milk chocolate. PMID:23455041

  14. 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.

  15. Reducing Trunk Compensation in Stroke Survivors: A Randomized Crossover Trial Comparing Visual and Force Feedback Modalities.

    Science.gov (United States)

    Valdés, Bulmaro Adolfo; Schneider, Andrea Nicole; Van der Loos, H F Machiel

    2017-10-01

    To investigate whether the compensatory trunk movements of stroke survivors observed during reaching tasks can be decreased by force and visual feedback, and to examine whether one of these feedback modalities is more efficacious than the other in reducing this compensatory tendency. Randomized crossover trial. University research laboratory. Community-dwelling older adults (N=15; 5 women; mean age, 64±11y) with hemiplegia from nontraumatic hemorrhagic or ischemic stroke (>3mo poststroke), recruited from stroke recovery groups, the research group's website, and the community. In a single session, participants received augmented feedback about their trunk compensation during a bimanual reaching task. Visual feedback (60 trials) was delivered through a computer monitor, and force feedback (60 trials) was delivered through 2 robotic devices. Primary outcome measure included change in anterior trunk displacement measured by motion tracking camera. Secondary outcomes included trunk rotation, index of curvature (measure of straightness of hands' path toward target), root mean square error of hands' movement (differences between hand position on every iteration of the program), completion time for each trial, and posttest questionnaire to evaluate users' experience and system's usability. Both visual (-45.6% [45.8 SD] change from baseline, P=.004) and force (-41.1% [46.1 SD], P=.004) feedback were effective in reducing trunk compensation. Scores on secondary outcome measures did not improve with either feedback modality. Neither feedback condition was superior. Visual and force feedback show promise as 2 modalities that could be used to decrease trunk compensation in stroke survivors during reaching tasks. It remains to be established which one of these 2 feedback modalities is more efficacious than the other as a cue to reduce compensatory trunk movement. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  16. Exploratory plasma proteomic analysis in a randomized crossover trial of aspirin among healthy men and women.

    Directory of Open Access Journals (Sweden)

    Xiaoliang Wang

    Full Text Available Long-term use of aspirin is associated with lower risk of colorectal cancer and other cancers; however, the mechanism of chemopreventive effect of aspirin is not fully understood. Animal studies suggest that COX-2, NFκB signaling and Wnt/β-catenin pathways may play a role, but no clinical trials have systematically evaluated the biological response to aspirin in healthy humans. Using a high-density antibody array, we assessed the difference in plasma protein levels after 60 days of regular dose aspirin (325 mg/day compared to placebo in a randomized double-blinded crossover trial of 44 healthy non-smoking men and women, aged 21-45 years. The plasma proteome was analyzed on an antibody microarray with ~3,300 full-length antibodies, printed in triplicate. Moderated paired t-tests were performed on individual antibodies, and gene-set analyses were performed based on KEGG and GO pathways. Among the 3,000 antibodies analyzed, statistically significant differences in plasma protein levels were observed for nine antibodies after adjusting for false discoveries (FDR adjusted p-value<0.1. The most significant protein was succinate dehydrogenase subunit C (SDHC, a key enzyme complex of the mitochondrial tricarboxylic acid (TCA cycle. The other statistically significant proteins (NR2F1, MSI1, MYH1, FOXO1, KHDRBS3, NFKBIE, LYZ and IKZF1 are involved in multiple pathways, including DNA base-pair repair, inflammation and oncogenic pathways. None of the 258 KEGG and 1,139 GO pathways was found to be statistically significant after FDR adjustment. This study suggests several chemopreventive mechanisms of aspirin in humans, which have previously been reported to play a role in anti- or pro-carcinogenesis in cell systems; however, larger, confirmatory studies are needed.

  17. Salacia Extract Improves Postprandial Glucose and Insulin Response: A Randomized Double-Blind, Placebo Controlled, Crossover Study in Healthy Volunteers

    Directory of Open Access Journals (Sweden)

    Shankaranarayanan Jeykodi

    2016-01-01

    Full Text Available Thirty-five healthy subjects were randomly assigned to different doses of Salacia chinensis extract (200 mg, 300 mg, and 500 mg SCE capsules and compared with placebo. It is a placebo controlled randomized crossover design study. Subjects were given oral sucrose solution along with capsules and plasma glucose and insulin responses were analyzed. Blood samples were collected at 0, 30, 60, 90, 120, and 180 minutes after administration. AUC insulin significantly lowered after ingestion of SCE. No significant adverse events were observed. Reducing glucose and insulin is very important in reducing postprandial hyperglycemia.

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

    Science.gov (United States)

    Knobe, Matthias; Carow, John Bennet; Ruesseler, Miriam; Leu, Benjamin Moritz; Simon, Melanie; Beckers, Stefan K; Ghassemi, Alireza; Sönmez, Tolga T; Pape, Hans-Christoph

    2012-09-09

    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. 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. 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 advantage concerning anatomical skills with higher spatial imagination in comparison to the ultrasound tutorial (p = 0.002; p < 0.001). The additional implementation of arthroscopy tutorials to the dissection course during the undergraduate anatomy training is profitable and

  20. 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

  1. Three-way flexible cantilever probes for static contact

    DEFF Research Database (Denmark)

    Wang, Fei; Petersen, Dirch Hjorth; Jensen, Helle Vendelbo

    2011-01-01

    In micro four-point probe measurements, three-way flexible L-shaped cantilever probes show significant advantages over conventional straight cantilever probes. The L-shaped cantilever allows static contact to the sample surface which reduces the frictional wear of the cantilever tips. We analyze...... the geometrical design space that must be fulfilled for the cantilevers to obtain static contact with the test sample. The design space relates the spring constant tensor of the cantilevers to the minimal value of the static tip-to-sample friction coefficient. Using an approximate model, we provide the analytical...

  2. Temporal analysis of social networks using three-way DEDICOM.

    Energy Technology Data Exchange (ETDEWEB)

    Bader, Brett William; Harshman, Richard A. (University of Ontario, London, Ontario, Canada); Kolda, Tamara Gibson (Sandia National Laboratories, Livermore, CA)

    2006-06-01

    DEDICOM is an algebraic model for analyzing intrinsically asymmetric relationships, such as the balance of trade among nations or the flow of information among organizations or individuals. It provides information on latent components in the data that can be regarded as ''properties'' or ''aspects'' of the objects, and it finds a few patterns that can be combined to describe many relationships among these components. When we apply this technique to adjacency matrices arising from directed graphs, we obtain a smaller graph that gives an idealized description of its patterns. Three-way DEDICOM is a higher-order extension of the model that has certain uniqueness properties. It allows for a third mode of the data, such as time, and permits the analysis of semantic graphs. We present an improved algorithm for computing three-way DEDICOM on sparse data and demonstrate it by applying it to the adjacency tensor of a semantic graph with time-labeled edges. Our application uses the Enron email corpus, from which we construct a semantic graph corresponding to email exchanges among Enron personnel over a series of 44 months. Meaningful patterns are recovered in which the representation of asymmetries adds insight into the social networks at Enron.

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

    Directory of Open Access Journals (Sweden)

    Anisse Penning

    2017-08-01

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

  4. Active video games and energy balance in male adolescents: a randomized crossover trial.

    Science.gov (United States)

    Gribbon, Aidan; McNeil, Jessica; Jay, Ollie; Tremblay, Mark S; Chaput, Jean-Philippe

    2015-06-01

    Active video games (AVGs) have been shown to acutely increase energy expenditure when compared with seated video games; however, the influence of AVGs on compensatory adjustments in energy intake and expenditure is largely unknown. The aim was to examine the acute effects of AVGs on energy intake and expenditure. With the use of a randomized crossover design, 26 male adolescents (mean ± SD age: 14.5 ± 1.4 y) completed three 1-h experimental conditions: resting control, seated video game play (Xbox 360; Microsoft), and AVG play (Kinect Adventures on Xbox 360) followed by an ad libitum lunch. A validated food menu was used to assess food intake immediately after the conditions and for the remainder of the day, and a dietary record was used for the subsequent 3-d period. Energy expenditure was measured by using portable indirect calorimetry throughout each experimental condition, and an accelerometer was used to assess the subsequent 3-d period. Appetite sensations were assessed by using visual analog scales at different time points during the testing day. The primary outcomes were acute (immediately after the conditions and 24-h) and short-term (3-d) energy intake and expenditure. Energy expenditure was significantly higher (~145%; P video game conditions; however, no significant differences in energy expenditure were observed 24 h (~6%; P > 0.49) and 3 d after the experimental conditions (~3%; P > 0.82). No significant differences were observed in absolute energy intake immediately after the conditions (~2%; P > 0.94) or in absolute energy intake 24 h (~5%; P > 0.63) and 3 d (~9%; P > 0.53) after the experimental conditions. Finally, appetite sensations were similar between conditions at all time points (P > 0.05). The increase in energy expenditure promoted by a single session of Kinect AVG play is not associated with increased food intake but is compensated for after the intervention, resulting in no measurable change in energy balance after 24 h. These results

  5. Reduction of smoking urges with intranasal insulin: a randomized, crossover, placebo-controlled clinical trial.

    Science.gov (United States)

    Hamidovic, A; Khafaja, M; Brandon, V; Anderson, J; Ray, G; Allan, A M; Burge, M R

    2017-10-01

    Many cigarette smokers express a desire to quit smoking, but ~85% of cessation attempts fail. In our attempt to delineate genetic modulators of smoking persistence, we have earlier shown that a locus within an ~250 kb haplotype block spanning the 5' untranslated region region of insulin-degrading enzyme is associated with serum cotinine levels; the study's measure of smoking quantity. Based on our findings, and coupled with recent preclinical studies showing the importance of multiple neuropeptides in reinstatement of drug use, we formulated intranasal insulin to evaluate its efficacy during acute abstinence from smoking. Our original study was a crossover trial including 19 otherwise healthy smokers who abstained from smoking for 36 h. The morning following their second night of abstinence, in random order, study participants received intranasal insulin (60 IU) or placebo (8.7% sodium chloride). The goal of our second study was to replicate the craving findings from the original trial and expand this research by including additional stress-related measures. Thirty-seven study participants abstained from smoking overnight. The next day, they were administered either intranasal insulin (60 IU) or placebo, following which they participated in the Trier Social Stress Test Task. This was a parallel design study focusing on the standard stress subjective, hormonal and cardiovascular measures. We also evaluated any changes in circulating glucose, insulin and c-peptide (a marker of endogenous insulin). In the original study, intranasal insulin significantly reduced morning nicotine craving (b=3.65, P⩽0.05). Similarly, in the second study, intranasal insulin reduced nicotine cravings over time (b=0.065, P⩽0.05) and the effect lasted through the psychosocial stress period. Intranasal insulin also increased circulating cortisol levels (F=12.78, P⩽0.001). No changes in insulin or c-peptide were detected. A significant treatment × time interaction (P⩽0.05) was

  6. Sodium bicarbonate ingestion improves Yo-Yo intermittent recovery test 1 performance: a randomized crossover trial

    Directory of Open Access Journals (Sweden)

    Dixon H

    2017-04-01

    Full Text Available Helen Dixon,1 Catherine E Baker,2 Julien S Baker,3 Susan Dewhurst,4 Lawrence D Hayes4 1School of Human Sciences, London Metropolitan University, London, 2English Institute of Sport, Bisham Abbey National Sports Center, Buckinghamshire, 3Institute of Clinical Exercise and Health Science, University of the West of Scotland, Hamilton, 4Department of Medical and Sport Sciences, University of Cumbria, Lancaster, UK Abstract: This study investigated the effect of sodium bicarbonate (NaHCO3– ingestion on the Yo-Yo intermittent recovery test 1 (IR1. We tested the hypothesis that acute ingestion of NaHCO3– would increase blood lactate concentrations [BLa], enhance performance, and reduce rating of perceived exertion (RPE in the Yo-Yo IR1. Eight recreationally active males (N=8, age: 26±4 yr, height: 178±6 cm, body mass: 82±10 kg participated in the Yo-Yo IR1 on two separate occasions, separated by 1 wk, in a randomized crossover design. Following familiarization, during seated rest, participants’ pretest [BLa] was taken, and participants then consumed either a placebo of 0.3 g·kg–1 body weight sodium chloride or 0.3 g·kg–1 body weight NaHCO3–. Sixty minutes postingestion, a standardized warm-up preceded the Yo-Yo IR1. Upon completion, postexercise [BLa] (mmol·L–1, RPE (arbitrary units and Yo-Yo IR1 time to fatigue (s were recorded. Paired t-test revealed a small but significant improvement in Yo-Yo IR1 performance under the NaHCO3– condition (610±267 sec, compared to the placebo condition (556±259 sec; p=0.01; Cohen’s d=0.20. [BLa] increased more under the NaHCO3– condition (1.6±0.7 to 17.5±5.2 mmol·L–1; p<0.001; Cohen’s d=4.29, compared to the placebo condition (2.0±0.7 to 11.5±5.0 mmol·L–1; p=0.001; Cohen’s d=2.66. Postexercise RPE was not significantly different between conditions. The results of this study suggest that acute NaHCO3– ingestion improves Yo-Yo IR1 performance without altering RPE, likely

  7. Impaired insulin signaling in human adipocytes after experimental sleep restriction: a randomized, crossover study.

    Science.gov (United States)

    Broussard, Josiane L; Ehrmann, David A; Van Cauter, Eve; Tasali, Esra; Brady, Matthew J

    2012-10-16

    Insufficient sleep increases the risk for insulin resistance, type 2 diabetes, and obesity, suggesting that sleep restriction may impair peripheral metabolic pathways. Yet, a direct link between sleep restriction and alterations in molecular metabolic pathways in any peripheral human tissue has not been shown. To determine whether sleep restriction results in reduced insulin sensitivity in subcutaneous fat, a peripheral tissue that plays a pivotal role in energy metabolism and balance. Randomized, 2-period, 2-condition, crossover clinical study. University of Chicago Clinical Resource Center. Seven healthy adults (1 woman, 6 men) with a mean age of 23.7 years (SD, 3.8) and mean body mass index of 22.8 kg/m(2) (SD, 1.6). Four days of 4.5 hours in bed or 8.5 hours in bed under controlled conditions of caloric intake and physical activity. Adipocytes collected from subcutaneous fat biopsy samples after normal and restricted sleep conditions were exposed to incremental insulin concentrations. The ability of insulin to increase levels of phosphorylated Akt (pAkt), a crucial step in the insulin-signaling pathway, was assessed. Total Akt (tAkt) served as a loading control. The insulin concentration for the half-maximal stimulation of the pAkt-tAkt ratio was used as a measure of cellular insulin sensitivity. Total body insulin sensitivity was assessed using a frequently sampled intravenous glucose tolerance test. The insulin concentration for the half-maximal pAkt-tAkt response was nearly 3-fold higher (mean, 0.71 nM [SD, 0.27] vs. 0.24 nM [SD, 0.24]; P = 0.01; mean difference, 0.47 nM [SD, 0.33]; P = 0.01), and the total area under the receiver-operating characteristic curve of the pAkt-tAkt response was 30% lower (P = 0.01) during sleep restriction than during normal sleep. A reduction in total body insulin sensitivity (P = 0.02) paralleled this impaired cellular insulin sensitivity. This was a single-center study with a small sample size. Sleep restriction results in an

  8. Spa therapy adjunct to pharmacotherapy is beneficial in rheumatoid arthritis: a crossover randomized controlled trial.

    Science.gov (United States)

    Karagülle, Mine; Kardeş, Sinan; Dişçi, Rian; Karagülle, Müfit Zeki

    2017-09-07

    This study aims to investigate whether 2-week spa therapy, as an adjunct to usual pharmacological therapy, has any beneficial effect in patients with rheumatoid arthritis (RA). In this single-blind crossover study, 50 patients were randomly assigned in a 1:1 manner to receive usual pharmacological therapy plus 2-week spa therapy or usual pharmacological therapy alone (period 1.6 months); after a 9-month washout, patients were crossed over to the opposite assignment (period 2.6 months). Spa therapy program included a daily saline balneotherapy session at 36-37 °C for 20 min except Sundays. The clinical outcomes were evaluated at baseline, after spa therapy (2 weeks) and 3 and 6 months after the spa therapy in both period and were pain (Visual Analogue Scale (VAS)), patient and physician global assessments (VAS), Health Assessment Questionnaire (HAQ), and Disease Activity Score (DAS28). Spa therapy was superior to control therapy in improving all the assessed clinical outcomes at the end of the spa therapy. This superiority persisted significantly in physician global assessment (p = 0.010) and with a trend in favor of spa group in patient global assessment (p = 0.058), function (p = 0.092), and disease activity (p = 0.098) at 3 months. Statistically significant improvements were found in spa therapy compared to control in disease activity (p = 0.006) and patient (p = 0.020) and physician global (p = 0.011) assessments, and a trend toward improvements in pain (p = 0.069) and swollen joints (p = 0.070) at 6 months. A 2-week spa therapy adjunct to usual pharmacological therapy provided beneficial clinical effects compared to usual pharmacological therapy alone, in RA patients treated with traditional disease-modifying antirheumatic drugs. These beneficial effects may last for 6 months.

  9. Masticatory performance of complete denture wearers after using two adhesives: a crossover randomized clinical trial.

    Science.gov (United States)

    de Oliveira Junior, Norberto Martins; Rodriguez, Larissa Santana; Mendoza Marin, Danny Omar; Paleari, André Gustavo; Pero, Ana Carolina; Compagnoni, Marco Antonio

    2014-11-01

    Masticatory performance analysis of conventional complete denture wearers who use denture adhesives is scarce in the dental literature. The purpose of this study was to assess the effect of the use of 2 denture adhesives on the masticatory performance of conventional complete denture wearers by means of a crossover study. Forty individuals who were edentulous received new maxillary and mandibular complete dentures, and, after an adaptation period, were submitted to masticatory performance analysis without denture adhesive (control). The participants were randomly divided and assigned to 2 protocols: protocol 1, denture adhesive 1 (Ultra Corega cream tasteless) use during the first 15 days, followed by no use of denture adhesive over the next 15 days (washout), and then use of denture adhesive 2 (Ultra Corega powder tasteless) for 15 days; protocol 2, denture adhesive 2 (Ultra Corega powder tasteless) use during the first 15 days, followed by no use of denture adhesive during the next 15 days (washout), and then use of denture adhesive 1 (Ultra Corega cream tasteless) for 15 days. The masticatory performance was assessed immediately after the use of denture adhesive by means of the sieve method, in which participants were instructed to deliberately chew 5 almonds for 20 chewing strokes. Masticatory performance was calculated by the weight of comminuted material that passed through the sieves. Data were analyzed by a 1-way ANOVA for paired samples and the multiple comparison of means by using the Bonferroni test (α=.05). A significant increase in masticatory performance was noted after using the Ultra Corega cream (mean, 32.6%) and Ultra Corega powder (mean, 31.2%) when compared with the control group (mean, 19.8%) (Padhesives evaluated. The use of denture adhesive improved the masticatory performance of conventional complete denture wearers. No difference was found in masticatory performance with the use of cream or powder denture adhesive. Copyright © 2014

  10. A randomized, three-period crossover study of umeclidinium as monotherapy in adult patients with asthma.

    Science.gov (United States)

    Lee, Laurie A; Briggs, Anne; Edwards, Lisa D; Yang, Shuying; Pascoe, Steven

    2015-01-01

    To our knowledge, no studies in patients with asthma have assessed a long-acting muscarinic antagonist in the absence of inhaled corticosteroids (ICS). Evaluate the dose-response, efficacy, and safety of umeclidinium (UMEC) in patients with asthma not receiving ICS. In this double-blind, three-period crossover study, 350 subjects were randomized to a sequence of three of eight inhaled treatments: UMEC 15.6, 31.25, 62.5, 125, or 250 mcg once daily (OD), UMEC 15.6 or 31.25 mcg twice daily (BID), or placebo, administered for 14 days (12-14-day washout). Trough forced expiratory volume in one second (FEV1), 0-24-h weighted mean (WM) FEV1, and safety were assessed. Serial spirometry and pharmacokinetic assessments were performed in a subgroup. Subjects had a mean baseline pre- and post-bronchodilator FEV1 of 71% and 88% predicted, respectively. Significant improvements in change from baseline trough FEV1 were observed for UMEC 15.6 OD (0.066 L; p = 0.036) and UMEC 125 OD (0.088 L; p = 0.005) versus placebo, but not other OD or BID doses. UMEC increased 0-24-h WM FEV1 versus placebo (0.068-0.121 L [p ≤ 0.017] with no clear dose-response). Treatment differences were similar for corresponding OD and BID doses in serial assessments. UMEC was rapidly absorbed, with evidence of some accumulation. The incidence of on-treatment adverse events was 9-21% for UMEC and 12% for placebo. There were no treatment-related effects on laboratory parameters. The modest trough FEV1 improvements did not conclusively support a therapeutic benefit of UMEC in non-ICS treated patients with asthma. NCT01641692. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  11. Cytopathology whole slide images and adaptive tutorials for senior medical students: a randomized crossover trial.

    Science.gov (United States)

    Van Es, Simone L; Kumar, Rakesh K; Pryor, Wendy M; Salisbury, Elizabeth L; Velan, Gary M

    2016-01-08

    Diagnostic cytopathology is an essential part of clinical decision-making. However, due to a combination of factors including curriculum reform and shortage of pathologists to teach introductory cytopathology, this area of pathology receives little or no formal attention in most medical school curricula. We have previously described the successful use of efficient and effective digital learning resources, including whole slide images (WSI) and virtual microscopy adaptive tutorials (VMATs), to teach cytopathology to pathology specialist trainees - a group that had prior exposure to cytopathology in their day to day practice. Consequently, in the current study we attempted to demonstrate the efficiency and efficacy of this eLearning resource in a cohort of senior medical students that was completely naïve to the subject matter (cytopathology). We evaluated both the quantitative and qualitative impact of these digital educational materials for learning cytopathology compared with existing resources (e-textbooks and online atlases). The senior medical students were recruited from The University of New South Wales Australia for a randomized cross-over trial. Online assessments, administered after each arm of the trial, contained questions which related directly to a whole slide image. Two categories of questions in the assessments (focusing on either diagnosis or identification of cellular features) were utilized to determine efficacy. User experience and perceptions of efficiency were evaluated using online questionnaires containing Likert scale items and open-ended questions. For this cohort of senior medical students, virtual microscopy adaptive tutorials (VMATs) proved to be at least as effective as existing digital resources for learning cytopathology. Importantly, virtual microscopy adaptive tutorials had superior efficacy in facilitating accurate diagnosis on whole slide images. Student perceptions of VMATs were positive, particularly regarding the immediate

  12. Three-way component analysis: principles and illustrative application.

    Science.gov (United States)

    Kiers, H A; Van Mechelen, I

    2001-03-01

    Three-way component analysis techniques are designed for descriptive analysis of 3-way data, for example, when data are collected on individuals, in different settings, and on different measures. Such techniques summarize all information in a 3-way data set by summarizing, for each way of the 3-way data set, the associated entities through a few components and describing the relations between these components. In this article, 3-mode principal components analysis is described at an elementary level. Guidance is given concerning the choices to be made in each step of the process of analyzing 3-way data by this technique. The complete process is illustrated with a detailed description of the analysis of an empirical 3-way data set.

  13. GASTRIC RESIDUAL VOLUME BY MAGNETIC RESSONANCE AFTER INTAKE OF MALTODEXTRIN AND GLUTAMINE: a randomized double-blind, crossover study

    OpenAIRE

    Luigi R BRIANEZ; Caporossi,Cervantes; Yure W de MOURA; Lorena A DIAS; Regis V LEAL; Aguilar-Nascimento,José E.

    2014-01-01

    ContextThe addition of glutamine in preoperative drinks may enhance the benefits of carbohydrate alone.ObjectivesTo evaluate the gastric residual volume after the intake of a beverage containing carbohydrate plus glutamine.MethodsEleven healthy volunteers (24-30 years-old) were randomized in a crossover fashion to intake 400 mL (4h before) and 200 mL (2h before) of a beverage containing either 12.5% maltodextrin (carbohydrate group) or 12.5% maltodextrin plus 15 g of glutamine (glutamine grou...

  14. Culture Three Ways: Culture and Subcultures Within Countries.

    Science.gov (United States)

    Oyserman, Daphna

    2017-01-03

    Culture can be thought of as a set of everyday practices and a core theme-individualism, collectivism, or honor-as well as the capacity to understand each of these themes. In one's own culture, it is easy to fail to see that a cultural lens exists and instead to think that there is no lens at all, only reality. Hence, studying culture requires stepping out of it. There are two main methods to do so: The first involves using between-group comparisons to highlight differences and the second involves using experimental methods to test the consequences of disruption to implicit cultural frames. These methods highlight three ways that culture organizes experience: (a) It shields reflexive processing by making everyday life feel predictable, (b) it scaffolds which cognitive procedure (connect, separate, or order) will be the default in ambiguous situations, and (c) it facilitates situation-specific accessibility of alternate cognitive procedures. Modern societal social-demographic trends reduce predictability and increase collectivism and honor-based go-to cognitive procedures.

  15. Bioavailability is improved by enzymatic modification of the citrus flavonoid hesperidin in humans: A randomized, double-blind, crossover trial

    DEFF Research Database (Denmark)

    Nielsen, I.L.F.; Chee, W.S.S.; Bredsdorff, Lea

    2006-01-01

    Hesperidin is the predominant polyphenol consumed from citrus fruits and juices. However, hesperidin is proposed to have limited bioavailability due to the rutinoside moiety attached to the flavonoid. The aim of this study was to demonstrate in human subjects that the removal of the rhamnose group...... to yield the corresponding flavonoid glucoside (i.e., hesperetin-7-glucoside) will improve the bioavailability of the aglycone hesperetin. Healthy volunteers (n = 16) completed the double-blind, randomized, crossover study. Subjects randomly consumed hesperetin equivalents supplied as orange juice...... that the bioavailability of hesperidin was modulated by enzymatic conversion to hesperetin-7-glucoside, thus changing the absorption site from the colon to the small intestine. This may affect future interventions concerning the health benefits of citrus flavonoids....

  16. Pictorial mnemonic-strategy interventions for children with special needs: Illustration of a multiply randomized single-case crossover design.

    Science.gov (United States)

    Hwang, Yooyeun; Levin, Joel R; Johnson, Evan W

    2016-01-25

    An innovative single-case crossover design containing multiple forms of randomization was implemented with eight participants in seven weekly sessions, during which instruction was given in the use of two different pictorial mnemonic (memory-enhancing) strategies: one designed to improve the children's learning of the dates of various inventions and the other designed to improve the children's acquisition of unfamiliar vocabulary items. A composite randomization statistical test revealed that when compared with the children's own preferred learning methods, the mnemonic-strategy approach produced the predicted facilitation effects. At the same time, it was evident that mnemonic instruction enhanced children's performance to a greater extent on the vocabulary task than on the inventions task. In-depth examination of both individual student performance profiles and the tasks/procedures were conducted, yielding recommendations and challenges for follow-up single-case intervention research on the topic.

  17. Response-Order Effects in Survey Methods: A Randomized Controlled Crossover Study in the Context of Sport Injury Prevention.

    Science.gov (United States)

    Chan, Derwin K; Ivarsson, Andreas; Stenling, Andreas; Yang, Sophie X; Chatzisarantis, Nikos L; Hagger, Martin S

    2015-12-01

    Consistency tendency is characterized by the propensity for participants responding to subsequent items in a survey consistent with their responses to previous items. This method effect might contaminate the results of sport psychology surveys using cross-sectional design. We present a randomized controlled crossover study examining the effect of consistency tendency on the motivational pathway (i.e., autonomy support → autonomous motivation → intention) of self-determination theory in the context of sport injury prevention. Athletes from Sweden (N = 341) responded to the survey printed in either low interitem distance (IID; consistency tendency likely) or high IID (consistency tendency suppressed) on two separate occasions, with a one-week interim period. Participants were randomly allocated into two groups, and they received the survey of different IID at each occasion. Bayesian structural equation modeling showed that low IID condition had stronger parameter estimates than high IID condition, but the differences were not statistically significant.

  18. 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...

  19. A randomized double-blind crossover trial comparing subthalamic and pallidal deep brain stimulation for dystonia

    DEFF Research Database (Denmark)

    Schjerling, Lisbeth; Hjermind, Lena E; Jespersen, Bo

    2013-01-01

    Object The authors' aim was to compare the subthalamic nucleus (STN) with the globus pallidus internus (GPi) as a stimulation target for deep brain stimulation (DBS) for medically refractory dystonia. Methods In a prospective double-blind crossover study, electrodes were bilaterally implanted in ...... with focal dystonia (torticollis) by examining the video recordings. Results On average for all patients, DBS improved the BFMDRS movement scores (p...... ratings were assessed by using the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) and video recordings. Quality of life was evaluated by using questionnaires (36-item Short Form Health Survey). Supplemental Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scores were assessed for patients...

  20. A multicenter randomized crossover multiple-dose comparison study of arotinolol and propranolol in essential tremor.

    Science.gov (United States)

    Lee, Kwang-Soo; Kim, Joong-Seok; Kim, Jae-Woo; Lee, Won-Yong; Jeon, Beum-Seok; Kim, Dongjae

    2003-08-01

    A new medication is needed to treat essential tremor. Preliminary evidence suggests that arotinolol may be effective in the treatment of this disorder. To study the effect of arotinolol and propranolol in a crossover, multiple dose comparative trial of patients with essential tremor. One hundred and seventy-five outpatients, with essential tremor were included in the study; 161 patients completed the study. Patients were identically evaluated at eight consecutive visits. The study consisted of two treatments, which were arranged according to a crossover design that evaluated the dose of each (arotinolol 10 mg per day and propranolol 40 mg per day, arotinolol 20 mg per day and propranolol 80 mg per day, arotinolol 30 mg per day and propranolol 160 mg per day). Each course of treatment lasted 6 weeks. Major outcome evaluations consisted of a self-reported disability scale, and motor performance score obtained before drug intake and 14 days after each treatment. The treatment effects were evaluated by analysis of variance using the Hills-Armitage test. Arotinolol was found to be as effective as propranolol at reducing tremor. Drug effects as evaluated using motor-task performance scores revealed that arotinolol had a more significant effect than propranolol. Arotinolol may be more useful than propranolol for the treatment of essential tremor.

  1. Influence of crossover on mortality in a randomized study of revascularization in patients with systolic heart failure and coronary artery disease.

    Science.gov (United States)

    Doenst, Torsten; Cleland, John G F; Rouleau, Jean L; She, Lilin; Wos, Stanislaw; Ohman, E Magnus; Krzeminska-Pakula, Maria; Airan, Balram; Jones, Robert H; Siepe, Matthias; Sopko, George; Velazquez, Eric J; Racine, Normand; Gullestad, Lars; Filgueira, Jose Luis; Lee, Kerry L

    2013-05-01

    To assess the influence of therapy crossovers on treatment comparisons and mortality at 5 years in patients with ischemic heart disease and heart failure randomly assigned to medical therapy alone (MED) or to MED and coronary artery bypass graft (CABG) surgery in the Surgical Treatment for Ischemic Heart Failure (STICH) trial. The influence of early crossover (within the first year after randomization) on 5-year mortality was assessed using time-dependent multivariable Cox models. CABG was performed in 65/602 patients (10.8%) assigned to MED, and 55/610 patients (9.0%) assigned to CABG received MED only. Common reasons for crossover from MED to CABG were progressive symptoms or acute decompensation. MED-assigned patients who underwent CABG had lower 5-year mortality than those who received MED only (25% vs 42%; hazard ratio, 0.50; 95% confidence interval, 0.30-0.85; P=0.008).The main reason for crossover from CABG to MED was patient/family decision. Five patients did not undergo their assigned CABG within a year but died before receiving surgery without status change. They were deemed crossover to MED. The CABG-to-MED crossover population had higher 5-year mortality compared with those treated with CABG per-protocol (59% vs 33%; hazard ratio, 2.01; 95% confidence interval, 1.36-2.96; P<0.001). CABG was associated with lower mortality compared with MED in per-protocol and several time-dependent analyses (all P<0.05). CABG reduced mortality in both the per-protocol and crossover STICH patient populations. Crossover from assigned therapy, therefore, diminished the impact of CABG on survival in STICH when analyzed by intention to treat. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00023595.

  2. Efficacy of Dental Floss and Chlorhexidine Mouth Rinse as an Adjunct to Toothbrushing in Removing Plaque and Gingival Inflammation – A Three Way Cross Over Trial

    Science.gov (United States)

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

    2014-01-01

    Background: Maintaining good oral hygiene is important to combat periodontal diseases. The use of tooth brush alone does not serve the purpose of removing plaque which demands the use of some adjuncts such as proximal cleaning aids. Aim: The study was conducted to compare the efficacy of Dental Floss and 0.12% Chlorhexidine Gluconate Mouthrinse as an adjunct to toothbrushing on plaque accumulation and gingival inflammation. Settings and Design: Department of Public Health Dentistry, Kothiwal Dental College and Research Centre, Moradabad, India. This was a randomized, double blind, three-way cross over clinical trial. Materials and Methods: Forty five dental students in the age group of 19-25yr. were enrolled into the study. Subjects were randomly assigned into three groups (n=15) i.e. Group A– Toothbrushing with Dental floss (TB+DF), Group B– Toothbrushing with 0.12% Chlorhexidine Gluconate Mouthrinse (TB+CHX-MR) and Group C– Toothbrushing alone (TB Alone) in a three-way crossover manner. After 21 d of trial period, plaque index (PI) and gingival index (GI) were assessed for each group, oral prophylaxis followed by a washout period for 14d. Statistical Analysis used: Mean, standard deviations and p-values were obtained. ANOVA test was used to compare the intergroup difference and Post hoc test to compare between the two groups. Results: The inter-group comparison for GI and PI at all interventions showed statistically significant difference (pplaque and gingival scores which was found to be statistically significant (ptoothbrushing is more effective in the reduction of plaque and gingival scores than a toothbrush alone or in combination with DF. PMID:25478436

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

    Science.gov (United States)

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

    2014-10-01

    Maintaining good oral hygiene is important to combat periodontal diseases. The use of tooth brush alone does not serve the purpose of removing plaque which demands the use of some adjuncts such as proximal cleaning aids. The study was conducted to compare the efficacy of Dental Floss and 0.12% Chlorhexidine Gluconate Mouthrinse as an adjunct to toothbrushing on plaque accumulation and gingival inflammation. Department of Public Health Dentistry, Kothiwal Dental College and Research Centre, Moradabad, India. This was a randomized, double blind, three-way cross over clinical trial. Forty five dental students in the age group of 19-25yr. were enrolled into the study. Subjects were randomly assigned into three groups (n=15) i.e. Group A- Toothbrushing with Dental floss (TB+DF), Group B- Toothbrushing with 0.12% Chlorhexidine Gluconate Mouthrinse (TB+CHX-MR) and Group C- Toothbrushing alone (TB Alone) in a three-way crossover manner. After 21 d of trial period, plaque index (PI) and gingival index (GI) were assessed for each group, oral prophylaxis followed by a washout period for 14d. Mean, standard deviations and p-values were obtained. ANOVA test was used to compare the intergroup difference and Post hoc test to compare between the two groups. The inter-group comparison for GI and PI at all interventions showed statistically significant difference (pplaque and gingival scores which was found to be statistically significant (ptoothbrushing is more effective in the reduction of plaque and gingival scores than a toothbrush alone or in combination with DF.

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

    Science.gov (United States)

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

    2013-09-01

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

  5. A randomized single blind crossover trial comparing leather and commercial wrist splints for treating chronic wrist pain in adults

    Directory of Open Access Journals (Sweden)

    Quinn Stephen

    2009-10-01

    Full Text Available Abstract Background To compare the effectiveness of a custom-made leather wrist splint (LS with a commercially available fabric splint (FS in adults with chronic wrist pain. Methods Participants (N = 25, mean age = 54 were randomly assigned to treatment order in a 2-phase crossover trial. Splints were worn for 2 weeks, separated by a one-week washout period. Outcomes were assessed at baseline and after each splint phase using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN, the Canadian Occupational Performance Measure (COPM and Jamar dynamometer by an observer blinded to treatment allocation. Results Both styles of wrist splint significantly reduced pain (effect size LS 0.79, FS 0.43, improved hand function and increased grip strength compared to baseline (all p Conclusion Leather wrist splints were superior to a commercially available fabric splint for the short-term relief of pain and dysfunction.

  6. Acute neurocognitive response to methylphenidate among survivors of childhood cancer: a randomized, double-blind, cross-over trial.

    Science.gov (United States)

    Conklin, Heather M; Khan, Raja B; Reddick, Wilburn E; Helton, Susan; Brown, Ronald; Howard, Scott C; Bonner, Melanie; Christensen, Robbin; Wu, Shengjie; Xiong, Xiaoping; Mulhern, Raymond K

    2007-10-01

    To investigate the acute efficacy and adverse side effects of methylphenidate (MPH) among survivors of childhood cancer [acute lymphoblastic leukemia (ALL) or brain tumor (BT)] with learning impairments. Participants (N = 122) completed a two-day, in-clinic, double-blind, cross-over trial during which they received MPH (0.60 mg/kg of body weight) and placebo that were randomized in administration order across participants. Performance was evaluated using measures of attention, memory, and academic achievement. A significant MPH versus placebo effect was revealed on a measure of attention, cognitive flexibility, and processing speed (Stroop Word-Color Association Test). Male gender, older age at treatment, and higher intelligence were predictive of better medication response. No significant differences were found for number or severity of adverse side effects as a function of active medication. MPH shows some neurocognitive benefit and is well tolerated by the majority of children surviving ALL and BT.

  7. Randomized crossover study comparing the phosphate-binding efficacy of calcium ketoglutarate versus calcium carbonate in patients on chronic hemodialysis

    DEFF Research Database (Denmark)

    Bro, S; Rasmussen, R A; Handberg, J

    1998-01-01

    The objective of the study was to evaluate the phosphate-binding efficacy, side effects, and cost of therapy of calcium ketoglutarate granulate as compared with calcium carbonate tablets in patients on chronic hemodialysis. The study design used was a randomized, crossover open trial, and the main...... outcome measurements were plasma ionized calcium levels, plasma phosphate levels, plasma intact parathyroid hormone (PTH) levels, requirements for supplemental aluminum-aminoacetate therapy, patient tolerance, and cost of therapy. Nineteen patients on chronic hemodialysis were treated with a dialysate......, diarrhea, general uneasiness), whereas the remaining 12 patients did not experience any side effects at all. The five patients with calcium ketoglutarate intolerance all had pre-existing gastrointestinal symptoms; four of them had received treatment with cimetidine or omeprazol before inclusion...

  8. 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

    2017-10-10

    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 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.

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

    NARCIS (Netherlands)

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

    2017-01-01

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

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

    DEFF Research Database (Denmark)

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

    2008-01-01

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

  11. A Randomized, Placebo-Controlled, Crossover Trial of Cannabis Cigarettes in Neuropathic Pain

    Science.gov (United States)

    Wilsey, Barth; Marcotte, Thomas; Tsodikov, Alexander; Millman, Jeanna; Bentley, Heather; Gouaux, Ben; Fishman, Scott

    2016-01-01

    The Food and Drug Administration (FDA), Substance Abuse and Mental Health Services Administration (SAMHSA), and the National Institute for Drug Abuse (NIDA) report that no sound scientific studies support the medicinal use of cannabis. Despite this lack of scientific validation, many patients routinely use “medical marijuana,” and in many cases this use is for pain related to nerve injury. We conducted a double-blinded, placebo-controlled, crossover study evaluating the analgesic efficacy of smoking cannabis for neuropathic pain. Thirty-eight patients with central and peripheral neuropathic pain underwent a standardized procedure for smoking either high-dose (7%), low-dose (3.5%), or placebo cannabis. In addition to the primary outcome of pain intensity, secondary outcome measures included evoked pain using heat-pain threshold, sensitivity to light touch, psychoactive side effects, and neuropsychological performance. A mixed linear model demonstrated an analgesic response to smoking cannabis. No effect on evoked pain was seen. Psychoactive effects were minimal and well-tolerated, with some acute cognitive effects, particularly with memory, at higher doses. PMID:18403272

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

    Directory of Open Access Journals (Sweden)

    Matthias Huber

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

  13. Mud-bath therapy and oral glucosamine sulfate in patients with knee osteoarthritis: a randomized, controlled, crossover study.

    Science.gov (United States)

    Peluso, Rosario; Caso, Francesco; Costa, Luisa; Sorbo, Dario; Carraturo, Nello; Di Minno, Matteo Nicola Dario; Carraturo, Federica; Oriente, Alfonso; Balestrieri, Umberto; Minicucci, Annamaria; Del Puente, Antonio; Scarpa, Raffaele

    2016-01-01

    To evaluate the efficacy and safety of combined treatment of mud-bath therapy and glucosamine crystalline sulfate (GlcN-S) in patients with knee osteoarthritis (OA). This study was a randomised, controlled, crossover investigation. Patients were randomly assigned (1:1) by the investigators to two groups, named group 1 and 2. Group 1 included twenty-three patients receiving oral GlcN-S treatment from the beginning of the study (T0) to the end of the 3rd month of treatment (T3) and a combined treatment of both mud-bath therapy and GlcN-S from T3 to the end of the study at six months (T6). Group 2 included twenty-two patients receiving a combined treatment of both mud-bath therapy and GlcN-S from T0 to T3 and that discontinued mud-bath therapy, receiving GlcN-S treatment alone, from T3 to T6. Primary endpoints of the study consisted of evaluating OA severity and activity at baseline and at follow-up visits. All 45 patients, eligible for the study, completed the period of the crossover. In group 1, no significant difference was shown in the comparison from T0 to T3, while from T3 to T6 most variables were significantly improved. In group 2, instead, the comparison between T0 and T3 showed a significant difference in different parameters. When comparing T3 and T6, despite an improvement of all the variables, no significant difference was shown. The association of GlcN-S and mud-bath therapy has a positive and safe role in improving pain, function and quality of life in knee OA patients.

  14. A Randomized Crossover Design to Assess Learning Impact and Student Preference for Active and Passive Online Learning Modules.

    Science.gov (United States)

    Prunuske, Amy J; Henn, Lisa; Brearley, Ann M; Prunuske, Jacob

    Medical education increasingly involves online learning experiences to facilitate the standardization of curriculum across time and space. In class, delivering material by lecture is less effective at promoting student learning than engaging students in active learning experience and it is unclear whether this difference also exists online. We sought to evaluate medical student preferences for online lecture or online active learning formats and the impact of format on short- and long-term learning gains. Students participated online in either lecture or constructivist learning activities in a first year neurologic sciences course at a US medical school. In 2012, students selected which format to complete and in 2013, students were randomly assigned in a crossover fashion to the modules. In the first iteration, students strongly preferred the lecture modules and valued being told "what they need to know" rather than figuring it out independently. In the crossover iteration, learning gains and knowledge retention were found to be equivalent regardless of format, and students uniformly demonstrated a strong preference for the lecture format, which also on average took less time to complete. When given a choice for online modules, students prefer passive lecture rather than completing constructivist activities, and in the time-limited environment of medical school, this choice results in similar performance on multiple-choice examinations with less time invested. Instructors need to look more carefully at whether assessments and learning strategies are helping students to obtain self-directed learning skills and to consider strategies to help students learn to value active learning in an online environment.

  15. A Double-Blind, Randomized, Crossover Study to Compare the Effectiveness of Montelukast on Atopic Dermatitis in Korean Children.

    Science.gov (United States)

    Jeon, You Hoon; Min, Taek Ki; Yang, Hyeon Jong; Pyun, Bok Yang

    2016-07-01

    Some studies report a role of leukotrienes in the pathogenesis of atopic dermatitis and suggest a rationale for the use of leukotriene receptor antagonist (LTRA) in the treatment of atopic dermatitis. This study aimed to evaluate the treatment effectiveness of montelukast in children with atopic dermatitis. Fifty-four children between the ages of 2 and 6 years with moderate to severe atopic dermatitis were enrolled. Group A received montelukast for 8 weeks, followed by a crossover to 8 weeks of placebo after a 2-week washout period. Group B reversed the administration according to a randomized, double-blind, placebo-controlled, crossover design. The SCORing atopic dermatitis (SCORAD) index, urinary leukotriene E₄ (LTE₄), and eosinophil-derived neurotoxin (EDN) were assessed at every visit. Forty-three patients (21 males) completed the study. Although the SCORAD index was decreased in both groups, there was no statistically significant difference between montelukast and placebo (-3.0±11.2 vs -5.7±11.3, P=0.43). The level of urinary LTE₄ was decreased after taking montelukast when compared to placebo, but there was no statistically significant difference (-65.9±556.2 vs 87.7±618.3, P=0.26). The changes in urinary EDN after taking montelukast and placebo had no significant difference (37.0±1,008.6 vs -195.8±916.7, P=0.10). When analyzing SCORAD indices, urinary LTE₄, and EDN, we could not prove the effectiveness of montelukast in the atopic, non-atopic or high ECP (ECP ≥15 μg/L) subgroups. There was no statistically significant difference in clinical improvement or biomarkers between montelukast and placebo treatment. Therefore, conventional treatments with skin care and infection control might be more important strategies in the treatment of atopic dermatitis.

  16. Early Functional Postoperative Therapy of Distal Radius Fracture with a Dynamic Orthosis: Results of a Prospective Randomized Cross-Over Comparative Study

    OpenAIRE

    Stuby, Fabian M.; Stefan Döbele; Susanne-Dorothea Schäffer; Simon Mueller; Atesch Ateschrang; Matthias Baumann; Derek Zieker

    2015-01-01

    Introduction 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 ap...

  17. Comparison of Avena sativa, vinegar, and hydroxyzine for uremic pruritus of hemodialysis patients: a crossover randomized clinical trial.

    Science.gov (United States)

    Nakhaee, Samaneh; Nasiri, Ahmad; Waghei, Yadollah; Morshedi, Jamileh

    2015-07-01

    Uremic pruritus is a common complication in patients with chronic kidney disease. While its cause is not known for certain, different treatments are currently applied. This study aimed to compare the effects of Avena sativa, diluted vinegar, and hydroxyzine on the reduction of uremic pruritus. In this crossover randomized clinical trial, 23 hemodialysis patients with uremic pruritus were randomly divided into 3 groups. The first group was treated with Avena sativa lotion, twice a day, for as long as 2 weeks; the second group received diluted vinegar; and the third group took hydroxyzine tablets for the same time span. After 3-day-long washout periods, the therapeutic methods were crossed over. The data were collected by a pruritus scale and a visual analogue scale, which were completed before and after the interventions. Avena sativa lotion significantly decreased the mean scores of pruritus intensity, consequences, and the verbal descriptor, although it did not have a significant effect on the frequency of pruritus and the pruritic surface. Vinegar and hydroxyzine significantly decreased all of the scores.  Conclusions. Avena sativa, vinegar, and hydroxyzine were effective in decreasing pruritus. Diluted vinegar and Avena sativa can be used as a complement to hydroxyzine, which is itself a common pharmaceutical therapy.

  18. kinesiotaping reduces pain and modulates sensory function in patients with focal dystonia: a randomized crossover pilot study.

    Science.gov (United States)

    Pelosin, Elisa; Avanzino, Laura; Marchese, Roberta; Stramesi, Paola; Bilanci, Martina; Trompetto, Carlo; Abbruzzese, Giovanni

    2013-10-01

    Pain is one of the most common and disabling "nonmotor" symptoms in patients with dystonia. No recent study evaluated the pharmacological or physical therapy approaches to specifically treat dystonic pain symptoms. To evaluate the effectiveness of KinesioTaping in patients with cervical dystonia (CD) and focal hand dystonia (FHD) on self-reported pain (primary objective) and on sensory functions (secondary objective). Twenty-five dystonic patients (14 with CD and 11 FHD) entered a randomized crossover pilot study. The patients were randomized to 14-day treatment with KinesioTaping or ShamTaping over neck (in CD) or forearm muscles (in FHD), and after a 30-day washout period, they received the other treatment. The were 3 visual analog scales (VASs) for usual pain, worst pain, and pain relief. Disease severity changes were evaluated by means of the Toronto Western Spasmodic Torticollis Rating Scale (CD) and the Writer's Cramp Rating Scale (FHD). Furthermore, to investigate possible KinesioTaping-induced effects on sensory functions, we evaluated the somatosensory temporal discrimination threshold. Treatment with KinesioTape induced a decrease in the subjective sensation of pain and a modification in the ability of sensory discrimination, whereas ShamTaping had no effect. A significant, positive correlation was found in both groups of patients between the improvement in the subjective sensation of pain and the reduction of somatosensory temporal discrimination threshold values induced by KinesioTaping. These preliminary results suggest that KinesioTaping may be useful in treating pain in patients with dystonia.

  19. Simplified versus comprehensive fabrication of complete dentures: patient ratings of denture satisfaction from a randomized crossover trial.

    Science.gov (United States)

    Heydecke, Guido; Vogeler, Michael; Wolkewitz, Martin; Türp, Jens C; Strub, Joerg R

    2008-02-01

    To determine if patient ratings of their ability to chew are dependent on the method of complete denture fabrication. Twenty edentulous patients participated in a randomized within-subject crossover trial. Each participant received 2 sets of new complete dentures. One pair (Gerber prosthesis) was manufactured based on tracings (to determine centric relation) and facebow transfer; semianatomic teeth with a lingualized and balanced occlusal pattern were used. The other set of complete dentures was made using a simplified procedure without facebow transfer; jaw relations were recorded with wax occlusion rims, and anatomic teeth were set with a canine and premolar guidance (Gysi prosthesis). The 2 dentures were delivered in randomized order, and each was worn for 3 months. Three months after insertion, patients' ratings of each new prosthesis were obtained on visual analog scales for general satisfaction, comfort, ability to speak, stability, esthetics, ease of cleaning, and ability to chew. Patients rated their general satisfaction, stability, and esthetic appearance significantly better for the Gysi prostheses ( P < .05). No significant differences between the 2 denture treatment methods were detected for ability to speak, comfort, chewing ability, and the ease of cleaning the dentures. A comprehensive method for the fabrication of complete dentures using lingualized teeth does not appear to positively influence patient ratings of denture satisfaction when compared to a simple procedure with anatomic teeth.

  20. Acute changes of hip joint range of motion using selected clinical stretching procedures: A randomized crossover study.

    Science.gov (United States)

    Hammer, Adam M; Hammer, Roger L; Lomond, Karen V; O'Connor, Paul

    2017-09-01

    Hip adductor flexibility and strength is an important component of athletic performance and many activities of daily living. Little research has been done on the acute effects of a single session of stretching on hip abduction range of motion (ROM). The aim of this study was to compare 3 clinical stretching procedures against passive static stretching and control on ROM and peak isometric maximal voluntary contraction (MVC). Using a randomized crossover study design, a total of 40 participants (20 male and 20 female) who had reduced hip adductor muscle length attended a familiarization session and 5 testing sessions on non-consecutive days. Following the warm-up and pre-intervention measures of ROM and MVC, participants were randomly assigned 1 of 3 clinical stretching procedures (modified lunge, multidirectional, and joint mobilization) or a static stretch or control condition. Post-intervention measures of ROM and MVC were taken immediately following completion of the assigned condition. An ANOVA using a repeated measure design with the change score was conducted. All interventions resulted in small but statistically significant (p stretching was greater than control (p = 0.031). These data suggest that a single session of stretching has only a minimal effect on acute changes of hip abduction ROM. Although hip abduction is a frontal plane motion, to effectively increase the extensibility of the structures that limit abduction, integrating multi-planar stretches may be indicated. Copyright © 2017 Elsevier Ltd. All rights reserved.

  1. Daily Consumption of Virgin Coconut Oil Increases High-Density Lipoprotein Cholesterol Levels in Healthy Volunteers: A Randomized Crossover Trial.

    Science.gov (United States)

    Chinwong, Surarong; Chinwong, Dujrudee; Mangklabruks, Ampica

    2017-01-01

    This open-label, randomized, controlled, crossover trial assessed the effect of daily virgin coconut oil (VCO) consumption on plasma lipoproteins levels and adverse events. The study population was 35 healthy Thai volunteers, aged 18-25. At entry, participants were randomly allocated to receive either (i) 15 mL VCO or (ii) 15 mL 2% carboxymethylcellulose (CMC) solution (as control), twice daily, for 8 weeks. After 8 weeks, participants had an 8-week washout period and then crossed over to take the alternative regimen for 8 weeks. Plasma lipoproteins levels were measured in participants at baseline, week-8, week-16, and week-24 follow-up visits. Results . Of 32 volunteers with complete follow-up (16 males and 16 females), daily VCO intake significantly increased high-density lipoprotein cholesterol by 5.72 mg/dL ( p = 0.001) compared to the control regimen. However, there was no difference in the change in total cholesterol, low-density lipoprotein cholesterol, and triglyceride levels between the two regimens. Mild diarrhea was reported by some volunteers when taking VCO, but no serious adverse events were reported. Conclusion . Daily consumption of 30 mL VCO in young healthy adults significantly increased high-density lipoprotein cholesterol. No major safety issues of taking VCO daily for 8 weeks were reported.

  2. Ebselen does not improve oxidative stress and vascular function in patients with diabetes: a randomized, crossover trial.

    Science.gov (United States)

    Beckman, Joshua A; Goldfine, Allison B; Leopold, Jane A; Creager, Mark A

    2016-12-01

    Oxidative stress is a key driver of vascular dysfunction in diabetes mellitus. Ebselen is a glutathione peroxidase mimetic. A single-site, randomized, double-masked, placebo-controlled, crossover trial was carried out in 26 patients with type 1 or type 2 diabetes to evaluate effects of high-dose ebselen (150 mg po twice daily) administration on oxidative stress and endothelium-dependent vasodilation. Treatment periods were in random order of 4 wk duration, with a 4-wk washout between treatments. Measures of oxidative stress included nitrotyrosine, plasma 8-isoprostanes, and the ratio of reduced to oxidized glutathione. Vascular ultrasound of the brachial artery and plethysmographic measurement of blood flow were used to assess flow-mediated and methacholine-induced endothelium-dependent vasodilation of conduit and resistance vessels, respectively. Ebselen administration did not affect parameters of oxidative stress or conduit artery or forearm arteriolar vascular function compared with placebo treatment. There was no difference in outcome by diabetes type. Ebselen, at the dose and duration evaluated, does not improve the oxidative stress profile, nor does it affect endothelium-dependent vasodilation in patients with diabetes mellitus. Copyright © 2016 the American Physiological Society.

  3. Increased calcium absorption from synthetic stable amorphous calcium carbonate: double-blind randomized crossover clinical trial in postmenopausal women.

    Science.gov (United States)

    Vaisman, Nachum; Shaltiel, Galit; Daniely, Michal; Meiron, Oren E; Shechter, Assaf; Abrams, Steven A; Niv, Eva; Shapira, Yami; Sagi, Amir

    2014-10-01

    Calcium supplementation is a widely recognized strategy for achieving adequate calcium intake. We designed this blinded, randomized, crossover interventional trial to compare the bioavailability of a new stable synthetic amorphous calcium carbonate (ACC) with that of crystalline calcium carbonate (CCC) using the dual stable isotope technique. The study was conducted in the Unit of Clinical Nutrition, Tel Aviv Sourasky Medical Center, Israel. The study population included 15 early postmenopausal women aged 54.9 ± 2.8 (mean ± SD) years with no history of major medical illness or metabolic bone disorder, excess calcium intake, or vitamin D deficiency. Standardized breakfast was followed by randomly provided CCC or ACC capsules containing 192 mg elemental calcium labeled with 44Ca at intervals of at least 3 weeks. After swallowing the capsules, intravenous CaCl2 labeled with 42Ca on was administered on each occasion. Fractional calcium absorption (FCA) of ACC and CCC was calculated from the 24-hour urine collection following calcium administration. The results indicated that FCA of ACC was doubled (± 0.96 SD) on average compared to that of CCC (p calcium supplementation. © 2014 American Society for Bone and Mineral Research.

  4. Metformin vs myoinositol: which is better in obese polycystic ovary syndrome patients? A randomized controlled crossover study.

    Science.gov (United States)

    Tagliaferri, Valeria; Romualdi, Daniela; Immediata, Valentina; De Cicco, Simona; Di Florio, Christian; Lanzone, Antonio; Guido, Maurizio

    2017-05-01

    Due to the central role of metabolic abnormalities in the pathophysiology of polycystic ovary syndrome (PCOS), insulin sensitizing agents have been proposed as a feasible treatment option. To investigate which is the more effective between metformin and myoinositol (MYO) on hormonal, clinical and metabolic parameters in obese patients with PCOS. Crossover randomized controlled study. Thirty-four PCOS obese women (age: 25·62 ± 4·7 years; BMI: 32·55 ± 5·67 kg/m2 ) were randomized to receive metformin (850 mg twice a day) or MYO (1000 mg twice a day) for 6 months. After a 3 month washout, the same subjects received the other compound for the following 6 months. Ultrasonographic pelvic examinations, hirsutism score, anthropometric and menstrual pattern evaluation, hormonal profile assays, oral glucose tolerance test (OGTT) and lipid profile at baseline and after 6 months of treatment were performed. Both metformin and MYO significantly reduced the insulin response to OGTT and improved insulin sensitivity. Metformin significantly decreased body weight and improved menstrual pattern and Ferriman-Gallwey score. Metformin treatment was also associated with a significant decrease in LH and oestradiol levels, androgens and anti-müllerian hormone levels. None of these clinical and hormonal changes were observed during MYO administration. Both treatments improved the glyco-insulinaemic features of obese PCOS patients, but only metformin seems to exert a beneficial effect on the endocrine and clinical features of the syndrome. © 2017 John Wiley & Sons Ltd.

  5. Bioavailability is improved by enzymatic modification of the citrus flavonoid hesperidin in humans: a randomized, double-blind, crossover trial.

    Science.gov (United States)

    Nielsen, Inge Lise F; Chee, Winnie S S; Poulsen, Lea; Offord-Cavin, Elizabeth; Rasmussen, Salka E; Frederiksen, Hanne; Enslen, Marc; Barron, Denis; Horcajada, Marie-Noelle; Williamson, Gary

    2006-02-01

    Hesperidin is the predominant polyphenol consumed from citrus fruits and juices. However, hesperidin is proposed to have limited bioavailability due to the rutinoside moiety attached to the flavonoid. The aim of this study was to demonstrate in human subjects that the removal of the rhamnose group to yield the corresponding flavonoid glucoside (i.e., hesperetin-7-glucoside) will improve the bioavailability of the aglycone hesperetin. Healthy volunteers (n=16) completed the double-blind, randomized, crossover study. Subjects randomly consumed hesperetin equivalents supplied as orange juice with natural hesperidin ("low dose"), orange juice treated with hesperidinase enzyme to yield hesperetin-7-glucoside, and orange juice fortified to obtain 3 times more hesperidin than naturally present ("high dose"). The area under the curve (AUC) for total plasma hesperetin of subjects consuming hesperetin-7-glucoside juice was 2-fold higher than that of subjects consuming the "low" dose hesperidin juice [3.45+/-1.27 vs. 1.16+/-0.52 mmol/(L.h), respectively, P>0.0001]. The AUC for hesperetin after consuming the hesperetin-7-glucoside juice was improved to the level of the "high" dose hesperidin juice [4.16+/-1.50 mmol/(L.h)]. The peak plasma concentrations (C(max)) of hesperetin were 4-fold higher (2.60+/-1.07 mmol/L, Phealth benefits of citrus flavonoids.

  6. Prospective randomized crossover study of simulation vs. didactics for teaching medical students the assessment and management of critically ill patients.

    Science.gov (United States)

    McCoy, Christopher Eric; Menchine, Michael; Anderson, Craig; Kollen, Robert; Langdorf, Mark I; Lotfipour, Shahram

    2011-04-01

    Simulation (SIM) allows medical students to manage high-risk/low-frequency cases in an environment without patient risk. However, evidence for the efficacy of SIM-based training remains limited. To compare SIM-based training to traditional didactic lecture (LEC) for teaching medical students to assess and manage critically ill patients with myocardial infarction (MI) and anaphylaxis. Prospective, randomized, non-blinded crossover study of 28 fourth-year medical students. Students were oriented to the human patient simulator, then randomized to SIM or LEC between August and December 2007. The SIM group learned to manage MI using SIM training and the LEC group learned via PowerPoint lecture. All subjects' assessment and management skills were then evaluated during a simulation session of MI. During a second instruction session, the students crossed over and were taught anaphylaxis using the opposite modality and similar assessments were conducted. Completion of critical actions for each case were scored, converted to percentages, and analyzed via signed rank test. Of 28 subjects, 27 performed better when trained with SIM compared with LEC (p didactic lecture for teaching fourth-year medical students to assess and manage simulated critically ill MI and anaphylaxis patients. Copyright © 2011 Elsevier Inc. All rights reserved.

  7. Comparing patient characteristics, type of intervention, control, and outcome (PICO) queries with unguided searching: a randomized controlled crossover trial.

    Science.gov (United States)

    Hoogendam, Arjen; de Vries Robbé, Pieter F; Overbeke, A John P M

    2012-04-01

    Translating a question into a query using patient characteristics, type of intervention, control, and outcome (PICO) should help answer therapeutic questions in PubMed searches. The authors performed a randomized crossover trial to determine whether the PICO format was useful for quick searches of PubMed. Twenty-two residents and specialists working at the Radboud University Nijmegen Medical Centre were trained in formulating PICO queries and then presented with a randomized set of questions derived from Cochrane reviews. They were asked to use the best query possible in a five-minute search, using standard and PICO queries. Recall and precision were calculated for both standard and PICO queries. Twenty-two physicians created 434 queries using both techniques. Average precision was 4.02% for standard queries and 3.44% for PICO queries (difference nonsignificant, t(21) = -0.56, P = 0.58). Average recall was 12.27% for standard queries and 13.62% for PICO queries (difference nonsignificant, t(21) = -0.76, P = 0.46). PICO queries do not result in better recall or precision in time-limited searches. Standard queries containing enough detail are sufficient for quick searches.

  8. Daily Consumption of Virgin Coconut Oil Increases High-Density Lipoprotein Cholesterol Levels in Healthy Volunteers: A Randomized Crossover Trial

    Directory of Open Access Journals (Sweden)

    Surarong Chinwong

    2017-01-01

    Full Text Available This open-label, randomized, controlled, crossover trial assessed the effect of daily virgin coconut oil (VCO consumption on plasma lipoproteins levels and adverse events. The study population was 35 healthy Thai volunteers, aged 18–25. At entry, participants were randomly allocated to receive either (i 15 mL VCO or (ii 15 mL 2% carboxymethylcellulose (CMC solution (as control, twice daily, for 8 weeks. After 8 weeks, participants had an 8-week washout period and then crossed over to take the alternative regimen for 8 weeks. Plasma lipoproteins levels were measured in participants at baseline, week-8, week-16, and week-24 follow-up visits. Results. Of 32 volunteers with complete follow-up (16 males and 16 females, daily VCO intake significantly increased high-density lipoprotein cholesterol by 5.72 mg/dL (p=0.001 compared to the control regimen. However, there was no difference in the change in total cholesterol, low-density lipoprotein cholesterol, and triglyceride levels between the two regimens. Mild diarrhea was reported by some volunteers when taking VCO, but no serious adverse events were reported. Conclusion. Daily consumption of 30 mL VCO in young healthy adults significantly increased high-density lipoprotein cholesterol. No major safety issues of taking VCO daily for 8 weeks were reported.

  9. A randomized, double-blind, placebo-controlled crossover study of ...

    African Journals Online (AJOL)

    Erectile dysfunction (ED) is one of the major health concerns affects the quality of life among Thai male. The treatment of ED by the first-line drugs is limited to a certain group of patients due to their side effects and costs. Alternative medicine can be beneficial for the treatment of ED. This is a randomized, double-blind, ...

  10. Randomized, Double-Blind, Crossover Trial of Amitriptyline for Analgesia in Painful HIV-Associated Sensory Neuropathy.

    Directory of Open Access Journals (Sweden)

    Natalya Dinat

    Full Text Available We conducted a randomized, double-blind, placebo-controlled, crossover study at a single center in South Africa, to ascertain whether amitriptyline is an effective analgesic for painful HIV-associated sensory neuropathy of moderate to severe intensity in: i antiretroviral drug naive individuals, and ii antiretroviral drug users. 124 HIV-infected participants (antiretroviral drug naive = 62, antiretroviral drug users = 62 who met the study criteria for painful HIV-associated sensory neuropathy were randomized to once-daily oral amitriptyline (titrated to a median: interquartile range of 50: 25-50 mg or placebo for six weeks, followed by a three-week washout period and subsequent treatment crossover. The primary outcome measure was change from baseline in worst pain intensity of the feet (measured by participant self-report using an 11-point numerical pain rating scale after six weeks of treatment. 122 of 124 participants completed all study visits and were included in the analysis of the primary outcome. In the antiretroviral drug-naive group (n = 61 there was no significant difference in the mean change in pain score from baseline after six weeks of treatment with placebo or amitriptyline [amitriptyline: 2.8 (SD 3.3 vs. placebo: 2.8 (3.4]. Similarly, there was no significant difference in the change in pain score after six weeks of treatment with placebo or amitriptyline in the antiretroviral drug-user group (n = 61 [amitriptyline: 2.7 (3.3 vs. placebo: 2.1 (2.8]. Controlling for period effects and treatment order effects did not alter the outcome of the analyses. Nor did analyzing the intention-to-treat cohort (missing data interpolated using baseline observation carried forward alter the outcome of the analyses. In summary, amitriptyline, at the doses used here, was no more effective than an inactive placebo at reducing pain intensity in individuals with painful HIV-associated sensory neuropathy of moderate to severe intensity, irrespective of

  11. The Effect of Head Massage on the Regulation of the Cardiac Autonomic Nervous System: A Pilot Randomized Crossover Trial.

    Science.gov (United States)

    Fazeli, Mir Sohail; Pourrahmat, Mir-Masoud; Liu, Mailan; Guan, Ling; Collet, Jean-Paul

    2016-01-01

    To evaluate the effect of a single 10-minute session of Chinese head massage on the activity of the cardiac autonomic nervous system via measurement of heart rate variability (HRV). In this pilot randomized crossover trial, each participant received both head massage and the control intervention in a randomized fashion. The study was conducted at Children's & Women's Health Centre of British Columbia between June and November 2014. Ten otherwise healthy adults (6 men and 4 women) were enrolled in this study. The intervention comprised 10 minutes of head massage therapy (HMT) in a seated position compared with a control intervention of sitting quietly on the same chair with eyes closed for an equal amount of time (no HMT). The primary outcome measures were the main parameters of HRV, including total power (TP), high frequency (HF), HF as a normalized unit, pre-ejection period, and heart rate (HR). A single short session (10 minutes) of head massage demonstrated an increase in TP continuing up to 20 minutes after massage and reaching statistical significance at 10 minutes after massage (relative change from baseline, 66% for HMT versus -6.6% for no HMT; p = 0.017). The effect on HF also peaked up to 10 minutes after massage (59.4% for HMT versus 4% for no HMT; p = 0.139). Receiving head massage also decreased HR by more than three-fold compared to the control intervention. This study shows the potential benefits of head massage by modulating the cardiac autonomic nervous system through an increase in the total variability and a shift toward higher parasympathetic nervous system activity. Randomized controlled trials with larger sample size and multiple sessions of massage are needed to substantiate these findings.

  12. 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; Pmodafinil therapy during the study period (P>0.05). Stroke survivors with nonresolving fatigue reported reduced fatigue and improved quality of life after taking 200 mg daily treatment with modafinil. URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368268. Unique identifier: ACTRN12615000350527. © 2017 The Authors.

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

    DEFF Research Database (Denmark)

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

    2008-01-01

    Serotonin (5-HT) is involved in pain modulation via descending pathways in the central nervous system. The aim of this study was to test if escitalopram, a selective serotonin reuptake inhibitor (SSRI), would relieve pain in polyneuropathy. The study design was a randomized, double-blind, placebo-controlled......- or pressure-evoked pain, lancinating pain, constant burning or deep aching pain) by the use of 0-10-point numeric rating scales. Changes in health-related quality of life and severity of depression were measured with the SF-36 and the Major Depression Inventory (MDI). Forty-one patients were included...

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

    Science.gov (United States)

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

    2014-09-23

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

  15. Difference in muscle activation patterns during high-speed versus standard-speed yoga: A randomized sequence crossover study.

    Science.gov (United States)

    Potiaumpai, Melanie; Martins, Maria Carolina Massoni; Wong, Claudia; Desai, Trusha; Rodriguez, Roberto; Mooney, Kiersten; Signorile, Joseph F

    2017-02-01

    To compare the difference in muscle activation between high-speed yoga and standard-speed yoga and to compare muscle activation of the transitions between poses and the held phases of a yoga pose. Randomized sequence crossover trial SETTING: A laboratory of neuromuscular research and active aging Interventions: Eight minutes of continuous Sun Salutation B was performed, at a high speed versus a standard-speed, separately. Electromyography was used to quantify normalized muscle activation patterns of eight upper and lower body muscles (pectoralis major, medial deltoids, lateral head of the triceps, middle fibers of the trapezius, vastus medialis, medial gastrocnemius, thoracic extensor spinae, and external obliques) during the high-speed and standard-speed yoga protocols. Difference in normalized muscle activation between high-speed yoga and standard-speed yoga. Normalized muscle activity signals were significantly higher in all eight muscles during the transition phases of poses compared to the held phases (pyoga across the entire session. Our results show that transitions from one held phase of a pose to another produces higher normalized muscle activity than the held phases of the poses and that overall activity is greater during highspeed yoga than standard-speed yoga. Therefore, the transition speed and associated number of poses should be considered when targeting specific improvements in performance. Copyright © 2016 Elsevier Ltd. All rights reserved.

  16. Effect of heat exposure and exercise on food intake regulation: A randomized crossover study in young healthy men.

    Science.gov (United States)

    Faure, Cécile; Charlot, Keyne; Henri, Stéphane; Hardy-Dessources, Marie-Dominique; Hue, Olivier; Antoine-Jonville, Sophie

    2016-10-01

    The effect of physical activity on food intake regulation may be moderated by environmental temperature. The aim of the study was to determine the single and combined effects of metabolic activity and temperature on energy intake and its hormonal regulation. A randomized crossover study was conducted in the laboratory. Ten healthy and physically active young Afro-Caribbean men participated in four experimental sessions (rest at 22°C and 31°C and cycling at 60% of their maximal oxygen uptake at 22°C and 31°C, all for 40 min). Each test period was followed by a 30-min recovery period and then an ad libitum meal. The main outcome measures were energy balance, subjective appetite, and plasma pancreatic polypeptide (PP), cholecystokinin (CCK) and ghrelin concentrations. Relative energy intake was significantly decreased whereas plasma PP was increased in the exercise conditions (p=0.004 and p=0.002, respectively). Postprandial levels of CCK were elevated only in the rest conditions. Exposure to heat induced a decrease in plasma ghrelin (p=0.031). Exercise induced a short-term energy deficit. However, modifications in the hormonal regulation of food intake in response to short-term heat or heat and exercise exposure seem to be minor and did not induce changes in energy intake. This trial was registered at clinicaltrials.gov as NCT02157233. Copyright © 2016. Published by Elsevier Inc.

  17. Effects of audiovisual distraction in children with special healthcare needs during dental restorations: a randomized crossover clinical trial.

    Science.gov (United States)

    Bagattoni, Simone; D'Alessandro, Giovanni; Sadotti, Agnese; Alkhamis, Nadia; Piana, Gabriela

    2017-04-11

    Audiovisual distraction using video eyeglasses is useful in managing distress and reducing fear and anxiety in healthy children during dental treatments. To evaluate the effect of audiovisual distraction on behavior and self-reported pain of children with special healthcare needs (SHCN) without intellectual disability during dental restorations and its influence on the operator stress and the time of the appointment. This randomized controlled crossover trial comprised 48 children with SHCN requiring at least two dental restorations. One restoration was done wearing the video eyeglasses and one wearing conventional behavior management techniques. Subjective and objective pain was evaluated using the Faces Pain Scale - Revised (FPS-R) and the revised Face, Leg, Activity, Cry, and Consolability scale (r-FLACC). The operator stress using a VAS, the time of the appointment, and the child satisfaction were recorded. The use of video eyeglasses significantly reduced the operator stress. The bivariate analysis showed that the mean FPS-R score and the mean r-FLACC score were significantly lower using the video eyeglasses only during the second clinical session. Audiovisual distraction could be useful in managing distress in SHCN children without intellectual disability but cannot replace the conventional behavior management techniques. © 2017 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  18. A randomized single blind crossover trial comparing leather and commercial wrist splints for treating chronic wrist pain in adults.

    Science.gov (United States)

    Thiele, Jill; Nimmo, Rachel; Rowell, Wendy; Quinn, Stephen; Jones, Graeme

    2009-10-21

    To compare the effectiveness of a custom-made leather wrist splint (LS) with a commercially available fabric splint (FS) in adults with chronic wrist pain. Participants (N = 25, mean age = 54) were randomly assigned to treatment order in a 2-phase crossover trial. Splints were worn for 2 weeks, separated by a one-week washout period. Outcomes were assessed at baseline and after each splint phase using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN), the Canadian Occupational Performance Measure (COPM) and Jamar dynamometer by an observer blinded to treatment allocation. Both styles of wrist splint significantly reduced pain (effect size LS 0.79, FS 0.43), improved hand function and increased grip strength compared to baseline (all p wrist stiffness. There was a consistent trend for the LS to be superior to the FS but this was statistically significant only for patient perceived occupational performance (p = 0.008) and satisfaction (p = 0.015). Lastly, 72% of patients preferred the custom-made leather splint compared to the commercially available splint. Leather wrist splints were superior to a commercially available fabric splint for the short-term relief of pain and dysfunction.

  19. Cardio- and cerebrovascular responses to the energy drink Red Bull in young adults: a randomized cross-over study.

    Science.gov (United States)

    Grasser, Erik K; Yepuri, Gayathri; Dulloo, Abdul G; Montani, Jean-Pierre

    2014-10-01

    Energy drinks are beverages containing vasoactive metabolites, usually a combination of caffeine, taurine, glucuronolactone and sugars. There are concerns about the safety of energy drinks with some countries banning their sales. We determined the acute effects of a popular energy drink, Red Bull, on cardiovascular and hemodynamic variables, cerebrovascular parameters and microvascular endothelial function. Twenty-five young non-obese and healthy subjects attended two experimental sessions on separate days according to a randomized crossover study design. During each session, primary measurements included beat-to-beat blood pressure measurements, impedance cardiography and transcranial Doppler measurements for at least 20 min baseline and for 2 h following the ingestion of either 355 mL of the energy drink or 355 mL of tap water; the endothelial function test was performed before and two hours after either drink. Unlike the water control load, Red Bull consumption led to increases in both systolic and diastolic blood pressure (p energy drink Red Bull, in particular an elevated blood pressure and double product and a lower cerebral blood flow velocity.

  20. Bupivacaine 0.5 % versus articaine 4 % for the removal of lower third molars. A crossover randomized controlled trial

    Science.gov (United States)

    Sancho-Puchades, Manuel; Vílchez-Pérez, Miguel A.; Paredes-García, Jordi; Berini-Aytés, Leonardo; Gay-Escoda, Cosme

    2012-01-01

    Objective: To compare the anesthetic action of 0.5% bupivacaine in relation to 4% articaine, both with 1:200,000 epinephrine, in the surgical removal of lower third molars. As a secondary objective hemodynamic changes using both anesthetics were analyzed. Study Design: Triple-blind crossover randomized clinical trial. Eighteen patients underwent bilateral removal of impacted lower third molars using 0.5% bupivacaine or 4% articaine in two different appointments. Preoperative, intraoperative and postoperative variables were recorded. Differences were assessed with McNemar tests and repeated measures ANOVA tests. Results: Both solutions exhibited similar latency times and intraoperative efficacy. Statistical significant lower pain levels were observed with bupivacaine between the fifth (p=0.011) and the ninth (p=0.007) postoperative hours. Bupivacaine provided significantly longer lasting soft tissue anesthesia (p<0.05). Systolic blood pressure and heart rate values were significantly higher with articaine. Conclusions: Bupivacaine could be a valid alternative to articaine especially due to its early postoperative pain prevention ability. Key words:Bupivacaine, articaine, third molar, anesthesia, postoperative pain. PMID:22143739

  1. 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

  2. Noninvasive Techniques for Blood Pressure Measurement Are Not a Reliable Alternative to Direct Measurement: A Randomized Crossover Trial in ICU

    Directory of Open Access Journals (Sweden)

    Sara Ribezzo

    2014-01-01

    Full Text Available Introduction. Noninvasive blood pressure (NIBP monitoring methods are widely used in critically ill patients despite poor evidence of their accuracy. The erroneous interpretations of blood pressure (BP may lead to clinical errors. Objectives. To test the accuracy and reliability of aneroid (ABP and oscillometric (OBP devices compared to the invasive BP (IBP monitoring in an ICU population. Materials and Methods. Fifty adult patients (200 comparisons were included in a randomized crossover trial. BP was recorded simultaneously by IBP and either by ABP or by OBP, taking IBP as gold standard. Results. Compared with ABP, IBP systolic values were significantly higher (mean difference ± standard deviation 9.74±13.8; P<0.0001. Both diastolic (-5.13±7.1; P<0.0001 and mean (-2.14±7.1; P=0.0033 IBP were instead lower. Compared with OBP, systolic (10.80±14.9; P<0.0001 and mean (5.36±7.1; P<0.0001 IBP were higher, while diastolic IBP (-3.62±6.0; P<0.0001 was lower. Bland-Altman plots showed wide limits of agreement in both NIBP-IBP comparisons. Conclusions. BP measurements with different devices produced significantly different results. Since in critically ill patients the importance of BP readings is often crucial, noninvasive techniques cannot be regarded as reliable alternatives to direct measurements.

  3. 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.

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

    Science.gov (United States)

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

    2017-10-23

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

  5. 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.

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

    Science.gov (United States)

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

    2017-08-25

    Both physical activity and relaxation have stress-relieving potential. This study investigates their combined impact on the relaxation response while considering participants' initial stress level. In a randomized cross-over trial, 81 healthy adults completed 4 types of short-term interventions for stress reduction, each lasting for 1 hr: (1) physical activity (walking) combined with resting, (2) walking combined with balneotherapy, (3) combined resting and balneotherapy, and (4) resting only. Saliva cortisol, blood pressure, state of mood, and relaxation were measured preintervention and postintervention. Stress levels were determined by validated questionnaires. All interventions were associated with relaxation responses in the variables saliva cortisol, blood pressure, state of mood, and subjective relaxation. No significant differences were found regarding the reduction of salivary cortisol (F = 1.30; p = .281). The systolic blood pressure was reduced best when walking was combined with balneotherapy or resting (F = 7.34; p < .001). Participants with high 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.

  7. A randomized, controlled, crossover trial of fish oil treatment for impulsive aggression in children and adolescents with disruptive behavior disorders.

    Science.gov (United States)

    Dean, Angela J; Bor, William; Adam, Kareen; Bowling, Francis G; Bellgrove, Mark A

    2014-04-01

    Epidemiological research links aggression to low serum concentrations of omega-3 fatty acids, such as those found in fish oil. However, no studies have specifically examined whether fish oil supplementation can reduce the frequency and severity of impulsive aggression in children with disruptive behavior disorders. Children presenting with impulsive aggression and meeting research criteria for diagnosis of disruptive behavior disorders were randomized to receive either: 1) Fish oil capsules (4 g daily) for 6 weeks followed by placebo (identical-looking capsules) for 6 weeks; or 2) placebo for 6 weeks, followed by fish oil for 6 weeks, in a double-blind, crossover design. Primary outcomes were the Children's Aggression Scale and the Modified Overt Aggression Scale. Secondary outcomes included emotional and behavioral functioning (Strengths and Difficulties Questionnaire [SDQ]), hyperactivity symptoms (Attention-Deficit/Hyperactivity Disorder [ADHD] Rating Scale), family functioning (Family Assessment Device), and cognitive functioning (Stop Signal Task, Trail-Making Task, and Eriksen Flanker Task). Serum concentrations of omega-3 and omega-6 fatty acids were measured at baseline, and at 6 and 12 weeks. Twenty-one children participated (81% male; mean age 10.3±2.2 years; range 7-14). Fish oil treatment increased serum concentrations of eicosapentanoic acid (F=14.76, pchildren with disruptive behavior disorders.

  8. Anaesthetic efficacy of 4% articaine compared with 2% mepivacaine: a randomized, double-blind, crossover clinical trial.

    Science.gov (United States)

    Bortoluzzi, M C; de Camargo Smolarek, P; Cecato, R; Pochapski, M T; Chibinski, A C R

    2017-11-30

    The aim of this study was to evaluate the clinical efficacy of 4% articaine (Ar4) compared to 2% mepivacaine (Me2), both in combination with 1:100,000 epinephrine, in a unique soft tissue model. This was a randomized, double-blind, crossover clinical trial. The anaesthetic was applied to the lower lip using a computerized local delivery system. The following were evaluated: blood flow, thermal sensation, pressure and proprioception, extent of anaesthesia, gradual elimination, and the final duration of the effect of the anaesthesia. Seventy-two volunteers completed all parts of the study. Significant differences, which indicated better effectiveness of Me2 compared to Ar4, were observed in the following tests: reduction in blood flow (larger in the Me2 group); anaesthetized area at 30min (larger in the Me2 group); pressure tests; temperature tests after 20min; fine and discriminatory proprioception tests after 20min. The volunteers' perception of anaesthesia at 30, 40, 50, and 60min was superior for Me2 at all recorded time points. The duration of anaesthesia was also superior for Me2. The overall performance of Me2 was superior to Ar4, implying that Me2 provides a more effective anaesthesia in terms of depth, extent, and duration. Copyright © 2017 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  9. An open-label, randomized, cross-over bioequivalence study of montelukast 10 mg tablets in healthy Thai volunteers

    Directory of Open Access Journals (Sweden)

    Chaveewan Ratanajamit

    2017-06-01

    Full Text Available To determine bioequivalence of a generic 10 mg montelukast tablet formulation. A 2-period, 2- sequence crossover study was designed. It included 28 healthy subjects, each subject received a single dose of the randomly assigned formulation with 240 ml water after 10-hr fasting, and 14 blood samples (6 mL each were drawn at predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 7, 10, 12 and 24 hr post-dose. The procedure was repeated after a 7-day washout period. Plasma samples were stored at -20°C until analysed using LC-MS/MS, LLOQ 5 ng/mL. The mean ± SD for the test and the reference were: Cmax 568±185 and 570±205 ng/mL; and AUC0-” 3864±1228 and 4022±1331 ng.hr/mL, respectively. The log-transformed ratios (90% CI were: Cmax : 99.64% (92.80% - 109.66%; and AUC0- : 99.79 (92.25% - 102.37%. The two formulations were bioequivalent as the 90% CI for the log-transformed ratios for the mean Cmax , and AUC0- were within the 80-125%.

  10. Randomized Crossover Study of the Natural Restorative Environment Intervention to Improve Attention and Mood in Heart Failure.

    Science.gov (United States)

    Jung, Miyeon; Jonides, John; Northouse, Laurel; Berman, Marc G; Koelling, Todd M; Pressler, Susan J

    In heart failure (HF), attention may be decreased because of lowered cerebral blood flow and increased attentional demands needed for self-care. Guided by the Attention Restoration Theory, the objective was to test the efficacy of the natural restorative environment (NRE) intervention on improving attention and mood among HF patients and healthy adults. A randomized crossover pilot study was conducted among 20 HF patients and an age- and education-matched comparison group of 20 healthy adults to test the efficacy of the NRE intervention compared with an active control intervention. Neuropsychological tests were administered to examine attention, particularly attention span, sustained attention, directed attention, and attention switching, at before and after the intervention. Mood was measured with the Positive and Negative Affect Schedule. No significant differences were found in attention and mood after the NRE intervention compared with the control intervention among the HF patients and the healthy adults. In analyses with HF patients and healthy adults combined (n = 40), significant differences were found. Compared with the control intervention, sustained attention improved after the NRE intervention (P = .001) regardless of the presence of HF. Compared with the healthy adults, HF patients performed significantly worse on attention switching after the control intervention (P = .045). The NRE intervention may be efficacious in improving sustained attention in HF patients. Future studies are needed to enhance the NRE intervention to be more efficacious and tailored for HF patients and test the efficacy in a larger sample of HF patients.

  11. The Diuretic Action of Weak and Strong Alcoholic Beverages in Elderly Men: A Randomized Diet-Controlled Crossover Trial.

    Science.gov (United States)

    Polhuis, Kristel C M M; Wijnen, Annemarthe H C; Sierksma, Aafje; Calame, Wim; Tieland, Michael

    2017-06-28

    With ageing, there is a greater risk of dehydration. This study investigated the diuretic effect of alcoholic beverages varying in alcohol concentration in elderly men. Three alcoholic beverages (beer (AB), wine (AW), and spirits (S)) and their non-alcoholic counterparts (non-alcoholic beer (NAB), non-alcoholic wine (NAW), and water (W)) were tested in a diet-controlled randomized crossover trial. For the alcoholic beverages, alcohol intake equaled a moderate amount of 30 g. An equal volume of beverage was given for the non-alcoholic counterpart. After consumption, the urine output was collected every hour for 4 h and the total 24 h urine output was measured. AW and S resulted in a higher cumulative urine output compared to NAW and W during the first 4 h (effect size: 0.25 mL p 0.40, p > 0.10). AB and NAB did not differ at any time point (effect size: -0.02 mL p > 0.70). For urine osmolality, and the sodium and potassium concentration, the findings were in line. In conclusion, only moderate amounts of stronger alcoholic beverages, such as wine and spirits, resulted in a short and small diuretic effect in elderly men.

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

    Directory of Open Access Journals (Sweden)

    Asli Akyol

    2014-09-01

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

  13. Randomized crossover study comparing the phosphate-binding efficacy of calcium ketoglutarate versus calcium carbonate in patients on chronic hemodialysis

    DEFF Research Database (Denmark)

    Bro, S; Rasmussen, R A; Handberg, J

    1998-01-01

    outcome measurements were plasma ionized calcium levels, plasma phosphate levels, plasma intact parathyroid hormone (PTH) levels, requirements for supplemental aluminum-aminoacetate therapy, patient tolerance, and cost of therapy. Nineteen patients on chronic hemodialysis were treated with a dialysate......The objective of the study was to evaluate the phosphate-binding efficacy, side effects, and cost of therapy of calcium ketoglutarate granulate as compared with calcium carbonate tablets in patients on chronic hemodialysis. The study design used was a randomized, crossover open trial, and the main...... lower in the ketoglutarate arm compared with the calcium carbonate arm (4.8+/-0.1 mg/dL v 5.2+/-0.1 mg/dL; P = 0.004), whereas the mean plasma phosphate (4.5+/-0.3 mg/dL v 5.1+/-0.1 mg/dL) and PTH levels (266+/-125 pg/mL v 301+/-148 pg/mL) did not differ significantly between the two treatment arms...

  14. Ultrasonography-guided radial artery catheterization is superior compared with the traditional palpation technique: a prospective, randomized, blinded, crossover study.

    Science.gov (United States)

    Hansen, M A; Juhl-Olsen, P; Thorn, S; Frederiksen, C A; Sloth, E

    2014-04-01

    Radial artery catheterization is gaining popularity for diagnostic and interventional procedures. Palpation technique is widely used for the procedure, but ultrasonography has been shown to increase catheterization success. A recently described ultrasonography technique is termed 'dynamic needle tip positioning'. We aimed to compare the traditional palpation technique and dynamic needle tip positioning technique in regard to clinically relevant end points. The study was conducted as a randomized, patient-blinded, crossover study. Patients underwent bilateral radial artery catheterization using both techniques. The primary end point of the study was needle manipulation time. Additional end points were (1) the number of skin perforations, (2) the number of attempts targeting the vessel, (3) the number of catheters placed in first attempt and (4) the number of catheters used. Forty patients were analyzed. There was no significant difference in median needle manipulation time [32 s (range 11-96 s) vs. 39 s (range 9-575 s), P = 0.525], although the variance was lower in the dynamic needle tip positioning group (P palpation technique group, a higher number of skin perforations (57 vs. 40, P = 0.003), catheters (46 vs. 40, P = 0.025) and attempts targeting the vessel (104 vs. 43, P technique for radial artery catheterization significantly improves clinically relevant aspects of the procedure. © 2014 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  15. 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.

  16. Gastric residual volume by magnetic ressonance after intake of maltodextrin and glutamine: a randomized double-blind, crossover study.

    Science.gov (United States)

    Brianez, Luigi R; Caporossi, Cervantes; de Moura, Yure W; Dias, Lorena A; Leal, Regis V; de Aguilar-Nascimento, José E

    2014-01-01

    The addition of glutamine in preoperative drinks may enhance the benefits of carbohydrate alone. To evaluate the gastric residual volume after the intake of a beverage containing carbohydrate plus glutamine. Eleven healthy volunteers (24-30 years-old) were randomized in a crossover fashion to intake 400 mL (4h before) and 200 mL (2h before) of a beverage containing either 12.5% maltodextrin (carbohydrate group) or 12.5% maltodextrin plus 15 g of glutamine (glutamine group) in two different moments 7 days apart. Magnetic ressonance was performed to measure the gastric residual volume (mL) 120 and 180 minutes after the last ingestion. Gastric residual volume similar to basal condition was found after 2h and 3h of the intake of beverages. There was no difference in the mean ±SD GRV (mL) found at 120 minutes (carbohydrate group: 22.9±16.6 and glutamine group: 19.7±10.7) and at 180 minutes (carbohydrate group: 21.5±24.1 and glutamine group: 15.1±10.1) between the two drinks. Gastric emptying is efficient, and occurs in up to two hours after the intake of a beverage containing either carbohydrate alone or carbohydrate associated with glutamine. The addition of glutamine to carbohydrate-enriched drink seems to be safe for the use up to 2h before an operation.

  17. Orange Pomace Improves Postprandial Glycemic Responses: An Acute, Randomized, Placebo-Controlled, Double-Blind, Crossover Trial in Overweight Men

    Directory of Open Access Journals (Sweden)

    C.-Y. Oliver Chen

    2017-02-01

    Full Text Available Orange pomace (OP, a fiber-rich byproduct of juice production, has the potential for being formulated into a variety of food products. We hypothesized that OP would diminish postprandial glycemic responses to a high carbohydrate/fat breakfast and lunch. We conducted an acute, randomized, placebo-controlled, double blind, crossover trial with 34 overweight men who consumed either a 255 g placebo (PLA, a low (35% OP (LOP, or a high (77% (HOP dose OP beverage with breakfast. Blood was collected at 0, 10, 20, 30, and 45 min and at 1, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 7, and 8 h. Lunch was consumed after the 5.5-h blood draw. OP delayed the time (Tmax1 to the maximum concentration (Cmax1 of serum glucose during the 2-h period post breakfast by ≥36% from 33 (PLA to 45 (HOP and 47 (LOP min (p = 0.055 and 0.013, respectively. OP decreased post-breakfast insulin Cmax1 by ≥10% and LOP delayed the Tmax1 by 14 min, compared to PLA at 46 min (p ≤ 0.05. HOP reduced the first 2-h insulin area under concentration time curve (AUC by 23% compared to PLA. Thus, OP diminishes postprandial glycemic responses to a high carbohydrate/fat breakfast and the second meal in overweight men.

  18. The lipid-lowering effect of tenofovir/emtricitabine: a randomized, crossover, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Santos, José R; Saumoy, María; Curran, Adrian; Bravo, Isabel; Llibre, Josep M; Navarro, Jordi; Estany, Carla; Podzamczer, Daniel; Ribera, Esteban; Negredo, Eugènia; Clotet, Bonaventura; Paredes, Roger

    2015-08-01

    It is unknown if tenofovir disoproxil fumarate (TDF), which is often coformulated with the lipid-neutral emtricitabine (FTC), has a lipid-lowering effect. We performed a randomized, crossover, double-blind, placebo-controlled clinical trial on human immunodeficiency virus type 1 (HIV-1)-infected subjects with HIV-1 RNA placebo (washout) and 12 additional weeks of placebo (placebo period). Subjects in arm 2 added placebo for 12 weeks (placebo period) followed by TDF/FTC for 12 weeks and placebo for 12 additional weeks (washout). The primary endpoint was change in median fasting TC levels. Of 46 subjects enrolled, 56% received darunavir/ritonavir and 44% lopinavir/ritonavir. Exposure to TDF/FTC reduced TC from 234 to 205 mg/dL (P placebo (P = .001 and P = .002, respectively). The TC/HDL-c ratio and triglyceride levels did not change with TDF/FTC exposure. Coformulated TDF/FTC has an intrinsic lipid-lowering effect, likely attributable to TDF. NCT01458977. © 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.

  19. Influence of heat and moisture exchanger respiratory load on transcutaneous oxygenation in laryngectomized individuals: a randomized crossover study.

    Science.gov (United States)

    Zuur, J Karel; Muller, Sara H; Sinaasappel, Michiel; Hart, Guus A M; van Zandwijk, Nico; Hilgers, Frans J M

    2007-12-01

    High-resistance heat and moisture exchangers (HMEs) have been reported to increase transcutaneous oxygenation (tcpO(2)) values in laryngectomized individuals and to negatively influence patient compliance. The goal of the present study was to validate earlier published results on short-term transcutaneous oxygenation changes by high-resistance HMEs. We conducted a randomized crossover study, monitoring the influence of an HME on tcpO(2) over a 2-hour time interval in 20 subjects. No evidence of an immediate HME effect (95% CI: -14.9-13.3 mm Hg, p = .91), or a time-dependent HME effect (95% CI: -.121 - .172 mm Hg/minute, p = .74), on tcpO(2) was found. After fitting the statistical model without time dependency, again no evidence of HME presence was seen (95% CI: -.5 mm Hg - 3.6 mm Hg, p = .15). In contrast to earlier suggestions, there is no evidence of increased tcpO(2) levels by high-resistance HMEs in laryngectomized individuals. Thus, using such HMEs has no added clinical value in this respect.

  20. Effects of a Bovine Lactoferrin Formulation from Cow’s Milk on Menstrual Distress in Volunteers: A Randomized, Crossover Study

    Directory of Open Access Journals (Sweden)

    Hiroshi M. Ueno

    2016-05-01

    Full Text Available Dysmenorrhea is a highly prevalent complaint and highly undiagnosed gynecologic condition. Dairy products have a potential in the management of menstrual distress, and bovine lactoferrin can help the subjective dysphoria associated with dysmenorrhea. In the present study, we aimed to investigate the effects of a lactoferrin formulation isolated from cow’s milk on menstrual symptoms in volunteers. A double-blind, randomized, placebo-controlled, crossover study of the iron-lactoferrin complex (FeLf was performed in thirty-five healthy Japanese women. Participants received the 150 mg FeLf (per day or placebo from day ten of the luteal phase to day four of the follicular phase. The Moos Menstrual Distress Questionnaire (MDQ was measured for menstrual distress, and heart rate variability was measured as an index of autonomic nerve balance during menses. A visual analog scale for menstrual pain, and a verbal rating scale for quality of life during the first three days of menstruation were measured. The MDQ score for the automatic nervous system subscale was lower and the parasympathetic nervous system activity was greater in FeLf than in placebo for intention-to-treat or per-protocol populations. The other variables were not different between the groups. No treatment-related side effects were observed during the study. The results indicate that FeLf can provide a beneficial effect on the psychological symptoms in women affected by menstrual distress.

  1. Effects of a Bovine Lactoferrin Formulation from Cow's Milk on Menstrual Distress in Volunteers: A Randomized, Crossover Study.

    Science.gov (United States)

    Ueno, Hiroshi M; Yoshise, Ran Emilie; Sugino, Tomohiro; Kajimoto, Osami; Kobayashi, Toshiya

    2016-05-31

    Dysmenorrhea is a highly prevalent complaint and highly undiagnosed gynecologic condition. Dairy products have a potential in the management of menstrual distress, and bovine lactoferrin can help the subjective dysphoria associated with dysmenorrhea. In the present study, we aimed to investigate the effects of a lactoferrin formulation isolated from cow's milk on menstrual symptoms in volunteers. A double-blind, randomized, placebo-controlled, crossover study of the iron-lactoferrin complex (FeLf) was performed in thirty-five healthy Japanese women. Participants received the 150 mg FeLf (per day) or placebo from day ten of the luteal phase to day four of the follicular phase. The Moos Menstrual Distress Questionnaire (MDQ) was measured for menstrual distress, and heart rate variability was measured as an index of autonomic nerve balance during menses. A visual analog scale for menstrual pain, and a verbal rating scale for quality of life during the first three days of menstruation were measured. The MDQ score for the automatic nervous system subscale was lower and the parasympathetic nervous system activity was greater in FeLf than in placebo for intention-to-treat or per-protocol populations. The other variables were not different between the groups. No treatment-related side effects were observed during the study. The results indicate that FeLf can provide a beneficial effect on the psychological symptoms in women affected by menstrual distress.

  2. Soy-protein consumption and kidney-related biomarkers among type 2 diabetics: a crossover, randomized clinical trial.

    Science.gov (United States)

    Azadbakht, Leila; Esmaillzadeh, Ahmad

    2009-11-01

    Renal disease is a major problem among diabetic patients. The type of protein consumed may affect alterations in kidney-related biomarkers in these patients. This study sought to assess the effects of soy-protein consumption on renal-related markers among type 2 diabetic patients with nephropathy. A crossover, randomized clinical trial was conducted among 14 patients (10 men and 4 women). One diet contained 0.8 g/kg protein (70% animal and 30% vegetable proteins), and a similar diet contained the same amount of protein with 35% animal protein, 35% soy protein, and 30% other vegetable proteins. These two diets were prescribed in each phase of the trial for 7 weeks. There was a 4-week washout between the two phases of the study. Consumption of soy protein reduced urinary urea nitrogen (-0.9 +/- 0.8 vs. 0.2 +/- 0.6 mg/dL, respectively, SD; P anima-protein consumption. Soy-protein consumption reduces proteinuria in type 2 diabetes with nephropathy.

  3. Customized Versus Noncustomized Sound Therapy for Treatment of Tinnitus: A Randomized Crossover Clinical Trial.

    Science.gov (United States)

    Mahboubi, Hossein; Haidar, Yarah M; Kiumehr, Saman; Ziai, Kasra; Djalilian, Hamid R

    2017-10-01

    To determine the effectiveness of a customized sound therapy and compare its effectiveness to that of masking with broadband noise. Subjects were randomized to receive either customized sound therapy or broadband noise for 2 hours per day for 3 months and then switched to the other treatment after a washout period. The outcome variables were tinnitus loudness (scored 0-10), Tinnitus Handicap Inventory (THI), Beck Anxiety Inventory (BAI), minimum masking levels (MML), and residual inhibition (RI). Eighteen subjects completed the study. Mean age was 53 ± 11 years, and mean tinnitus duration was 118 ± 99 months. With customized sound therapy, mean loudness decreased from 6.4 ± 2.0 to 4.9 ± 1.9 ( P = .001), mean THI decreased from 42.8 ± 21.6 to 31.5 ± 20.3 ( P tinnitus patients, and the results may be superior to broadband noise.

  4. Effect of Zolpidem on Sleep Quality of Professional Firefighters; a Double Blind, Randomized, Placebo-Controlled Crossover Clinical Trial

    Directory of Open Access Journals (Sweden)

    Ramin Mehrdad

    2015-10-01

    Full Text Available Professional firefighting is among the most demanding jobs. Prior studies have showed the notable prevalence of poor sleep quality among professional firefighters that may result in catastrophes. The aim of this study was in field confirmation of zolpidem usage (10 mg/PO/bed time for short term management of poor sleeps quality among professional firefighters. In a double-blind, randomized, placebo-controlled crossover clinical trial among professional firefighters, 27 poor sleepers were assigned randomly to one of the two groups. Two 14 days experimental periods were separated by a 14-day washout phase. Sleep quality was assessed using the Persian version of Pittsburgh Sleep Quality Index (PSQI. Six of the 27 enrolled voluntaries dropped out. Two rare side effects of zolpidem occurred in the study. A significant improvement of the PSQI score was detected in zolpidem period versus placebo in both groups (7.14 ± 3.02 vs 12.38 ± 2.51, PP=0.89. Zolpidem significantly improved all components of PSQI (Subjective sleep quality, Sleep latency, Sleep duration, Habitual sleep efficiency, Sleep disturbances and Daytime dysfunction in the current study except the use of sleep medication. Sleep onset latency was the component of PSQI with the greatest degree of abnormality among firefighters in a previous study. Interestingly, sleep latency was the component of PSQI with the most treatment effect of zolpidem in the current study. Zolpidem can be used as a part of treatment regimens in short time management of poor sleep quality among professional firefighters.

  5. Aspirin Reduces Plasma Concentrations of the Oncometabolite 2-Hydroxyglutarate: Results of a Randomized, Double-Blind, Crossover Trial

    Science.gov (United States)

    Liesenfeld, David B.; Botma, Akke; Habermann, Nina; Toth, Reka; Weigel, Christoph; Popanda, Odilia; Klika, Karel D.; Potter, John D.; Lampe, Johanna W.; Ulrich, Cornelia M.

    2015-01-01

    Background Aspirin use is an effective strategy for the chemoprevention of colorectal cancer, even at low doses. However, in order to implement aspirin interventions, risk–benefit balances and biological mechanisms need to be better defined; to further this aim, we used a metabolomics approach. Methods We metabolically profiled 40 healthy, non-smoking men and women aged 20–45 years enrolled in a randomized, double-blind, crossover trial of 325 mg aspirin/d over 60 days. Gas and liquid chromatography–mass spectrometry were used to comprehensively profile participants’ plasma samples after aspirin and placebo interventions. Results A total of 363 metabolites, covering most human biochemical pathways, were measured. Compared to placebo-treated participants, plasma concentrations of the oncometabolite 2-hydroxyglutarate (R+S) decreased after aspirin treatment in both men and women (p = 0.005). This signal proved robust during 20-fold random splitting of the data using 80% of the samples in each split. We subsequently performed functional follow-up studies using targeted, enantiospecific detection in human colorectal cancer cell lines and observed an aspirin-induced reduction of (R)-2-hydroxyglutarate. We further showed that salicylate, the primary aspirin metabolite, inhibits the hydroxyacid–oxoacid transhydrogenase (HOT) mediated production of (R)-2-hydroxyglutarate, thereby providing mechanistic evidence for the clinically observed effects of aspirin on total-2-hydroxyglutarate. Conclusion Using a metabolomics approach with functional follow-up, we propose that a decrease in the oncometabolite (R)-2-hydroxyglutarate may identify an additional mechanism for aspirin or its metabolites in cancer prevention. Impact Reduction of the oncometabolite (R)-2-hydroxyglutarate identifies a novel, non-COX-inhibition-mediated mechanism of aspirin. PMID:26585118

  6. Targeted HIV Screening in Eight Emergency Departments: The DICI-VIH Cluster-Randomized Two-Period Crossover Trial.

    Science.gov (United States)

    Leblanc, Judith; Hejblum, Gilles; Costagliola, Dominique; Durand-Zaleski, Isabelle; Lert, France; de Truchis, Pierre; Verbeke, Geert; Rousseau, Alexandra; Piquet, Hélène; Simon, François; Pateron, Dominique; Simon, Tabassome; Crémieux, Anne-Claude

    2017-10-30

    This study compares the effectiveness and cost-effectiveness of nurse-driven targeted HIV screening alongside physician-directed diagnostic testing (intervention strategy) with diagnostic testing alone (control strategy) in 8 emergency departments. In this cluster-randomized, 2-period, crossover trial, 18- to 64-year-old patients presenting for reasons other than potential exposure to HIV were included. The strategy applied first was randomly assigned. During both periods, diagnostic testing was prescribed by physicians following usual care. During the intervention periods, patients were asked to complete a self-administered questionnaire. According to their answers, the triage nurse suggested performing a rapid test to patients belonging to a high-risk group. The primary outcome was the proportion of new diagnoses among included patients, which further refers to effectiveness. A secondary outcome was the intervention's incremental cost (health care system perspective) per additional diagnosis. During the intervention periods, 74,161 patients were included, 16,468 completed the questionnaire, 4,341 belonged to high-risk groups, and 2,818 were tested by nurses, yielding 13 new diagnoses. Combined with 9 diagnoses confirmed through 97 diagnostic tests, 22 new diagnoses were established. During the control periods, 74,166 patients were included, 92 were tested, and 6 received a new diagnosis. The proportion of new diagnoses among included patients was higher during the intervention than in the control periods (3.0 per 10,000 versus 0.8 per 10,000; difference 2.2 per 10,000, 95% CI 1.3 to 3.6; relative risk 3.7, 95% CI 1.4 to 9.8). The incremental cost was €1,324 per additional new diagnosis. The combined strategy of targeted screening and diagnostic testing was effective. Copyright © 2017 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

  7. Pharmacokinetics of lacosamide and omeprazole coadministration in healthy volunteers: results from a phase I, randomized, crossover trial.

    Science.gov (United States)

    Cawello, Willi; Mueller-Voessing, Christa; Fichtner, Andreas

    2014-05-01

    The antiepileptic drug lacosamide has a low potential for drug-drug interactions, but is a substrate and moderate inhibitor of the cytochrome P450 (CYP) enzyme CYP2C19. This phase I, randomized, open-label, two-way crossover trial evaluated the pharmacokinetic effects of lacosamide and omeprazole coadministration. Healthy, White, male volunteers (n = 36) who were not poor metabolizers of CYP2C19 were randomized to treatment A (single-dose 40 mg omeprazole on days 1 and 8 together with 6 days of multiple-dose lacosamide [200-600 mg/day] on days 3-8) and treatment B (single doses of 300 mg lacosamide on days 1 and 8 with 7 days of 40 mg/day omeprazole on days 3-9) in pseudorandom order, separated by a ≥ 7-day washout period. Area under the concentration-time curve (AUC) and peak concentration (C(max)) were the primary pharmacokinetic parameters measured for lacosamide or omeprazole administered alone (reference) or in combination (test). Bioequivalence was determined if the 90 % confidence interval (CI) of the ratio (test/reference) fell within the acceptance range of 0.8-1.25. The point estimates (90 % CI) of the ratio of omeprazole + lacosamide coadministered versus omeprazole alone for AUC (1.098 [0.996-1.209]) and C(max) (1.105 [0.979-1.247]) fell within the acceptance range for bioequivalence. The point estimates (90 % CI) of the ratio of lacosamide + omeprazole coadministration versus lacosamide alone also fell within the acceptance range for bioequivalence (AUC 1.133 [1.102-1.165]); C(max) 0.996 (0.947-1.047). Steady-state lacosamide did not influence omeprazole single-dose pharmacokinetics, and multiple-dose omeprazole did not influence lacosamide single-dose pharmacokinetics.

  8. Home-based balance training using the Wii balance board: a randomized, crossover pilot study in multiple sclerosis.

    Science.gov (United States)

    Prosperini, Luca; Fortuna, Deborah; Giannì, Costanza; Leonardi, Laura; Marchetti, Maria Rita; Pozzilli, Carlo

    2013-01-01

    To evaluate the effectiveness of a home-based rehabilitation of balance using the Nintendo Wii Balance Board System (WBBS) in patients affected by multiple sclerosis (MS). In this 24-week, randomized, 2-period crossover pilot study, 36 patients having an objective balance disorder were randomly assigned in a 1:1 ratio to 2 counterbalanced arms. Group A started a 12-week period of home-based WBBS training followed by a 12-week period without any intervention; group B received the treatment in reverse order. As endpoints, we considered the mean difference (compared with baseline) in force platform measures (i.e., the displacement of body center of pressure in 30 seconds), 4-step square test (FSST), 25-foot timed walking test (25-FWT), and 29-item MS Impact Scale (MSIS-29), as evaluated after 12 weeks and at the end of the 24-week study period. The 2 groups did not differ in baseline characteristics. Repeated-measures analyses of variance showed significant time × treatment effects, indicating that WBBS was effective in ameliorating force platform measures (F = 4.608, P = .016), FSST (F = 3.745, P = .034), 25-FWT (F = 3.339, P = .048), and MSIS-29 (F = 4.282, P = .023). Five adverse events attributable to the WBSS training (knee or low back pain) were recorded, but only 1 patient had to retire from the study. A home-based WBBS training might potentially provide an effective, engaging, balance rehabilitation solution for people with MS. However, the risk of WBBS training-related injuries should be carefully balanced with benefits. Further studies, including cost-effectiveness analyses, are warranted to establish whether WBBS may be useful in the home setting.

  9. Associations between urinary biomarkers of oxidative stress and air pollutants observed in a randomized crossover exposure to steel mill emissions.

    Science.gov (United States)

    Pelletier, Guillaume; Rigden, Marc; Kauri, Lisa Marie; Shutt, Robin; Mahmud, Mamun; Cakmak, Sabit; Kumarathasan, Premkumari; Thomson, Errol M; Vincent, Renaud; Broad, Gayle; Liu, Ling; Dales, Robert

    2017-04-01

    The effects of industrial air pollution on human health have not been as thoroughly investigated as those of urban air pollution which originates mostly from automotive transport. To better assess the health impacts of point sources of industrial air pollution, a randomized crossover exposure study was conducted. Sixty one young and healthy volunteers were randomly assigned to spend five consecutive eight-hour days near a steel mill or at a location five kilometres away. After a nine or sixteen-day washout period, volunteers spent another five consecutive days at the second site. Meteorological conditions and air pollutants were monitored at both exposure sites. On each exposure day, the first morning urine was collected along with a second urine sample obtained immediately before leaving the exposure site at the end of the day. Urinary levels of biomarkers of oxidative stress 8-hydroxy-2'-deoxyguanosine (8-OHdG, a biomarker of oxidative DNA damage), malondialdehyde (MDA, a biomarker of lipid peroxidation), 8-isoprostane (8-IsoP, a bioactive metabolite resulting from the peroxidation of arachidonic acid) and Vascular Endothelial Growth Factor (VEGF, involved in response to oxidative stress) were measured. According to mixed-effects linear regression models, intra-individual variations in 8-OHdG urinary levels were significantly associated with exposure site, but surprisingly, lower levels were observed at the steel mill site. Delayed, temporally-defined associations with specific air pollutants were observed for 8-OHdG, 8-IsoP and VEGF. However, these associations were subtle, presented complex patterns and their biological consequences remain unclear. Crown Copyright © 2016. Published by Elsevier GmbH. All rights reserved.

  10. Effects of ethnic attributes on the quality of family planning services in Lima, Peru: a randomized crossover trial.

    Directory of Open Access Journals (Sweden)

    Maria-Elena Planas

    Full Text Available Most studies reporting ethnic disparities in the quality of healthcare come from developed countries and rely on observational methods. We conducted the first experimental study to evaluate whether health providers in Peru provide differential quality of care for family planning services, based on the indigenous or mestizo (mixed ethnoracial ancestry profile of the patient. In a crossover randomized controlled trial conducted in 2012, a sample of 351 out of the 408 public health establishments in Metropolitan Lima, Peru were randomly assigned to receive unannounced simulated patients enacting indigenous and mestizo profiles (sequence-1 or mestizo and then indigenous profiles (sequence-2, with a five week wash-out period. Both ethnic profiles used the same scripted scenario for seeking contraceptive advice but had distinctive cultural attributes such as clothing, styling of hair, make-up, accessories, posture and patterns of movement and speech. Our primary outcome measure of quality of care is the proportion of technical tasks performed by providers, as established by Peruvian family planning clinical guidelines. Providers and data analysts were kept blinded to the allocation. We found a non-significant mean difference of -0.7% (p = 0.23 between ethnic profiles in the percentage of technical tasks performed by providers. However we report large deficiencies in the compliance with quality standards of care for both profiles. Differential provider behaviour based on the patient's ethnic profiles compared in the study did not contribute to deficiencies in family planning outcomes observed. The study highlights the need to explore other determinants for poor compliance with quality standards, including demand and supply side factors, and calls for interventions to improve the quality of care for family planning services in Metropolitan Lima.

  11. Prospective randomized crossover study of a new closed-loop control system versus pressure support during weaning from mechanical ventilation.

    Science.gov (United States)

    Clavieras, Noémie; Wysocki, Marc; Coisel, Yannael; Galia, Fabrice; Conseil, Matthieu; Chanques, Gerald; Jung, Boris; Arnal, Jean-Michel; Matecki, Stefan; Molinari, Nicolas; Jaber, Samir

    2013-09-01

    Intellivent is a new full closed-loop controlled ventilation that automatically adjusts both ventilation and oxygenation parameters. The authors compared gas exchange and breathing pattern variability of Intellivent and pressure support ventilation (PSV). In a prospective, randomized, single-blind design crossover study, 14 patients were ventilated during the weaning phase, with Intellivent or PSV, for two periods of 24 h in a randomized order. Arterial blood gases were obtained after 1, 8, 16, and 24 h with each mode. Ventilatory parameters were recorded continuously in a breath-by-breath basis during the two study periods. The primary endpoint was oxygenation, estimated by the calculation of the difference between the PaO2/FIO2 ratio obtained after 24 h of ventilation and the PaO2/FIO2 ratio obtained at baseline in each mode. The variability in the ventilatory parameters was also evaluated by the coefficient of variation (SD to mean ratio). There were no adverse events or safety issues requiring premature interruption of both modes. The PaO2/FIO2 (mean ± SD) ratio improved significantly from 245 ± 75 at baseline to 294 ± 123 (P = 0.03) after 24 h of Intellivent. The coefficient of variation of inspiratory pressure and positive end-expiratory pressure (median [interquartile range]) were significantly higher with Intellivent, 16 [11-21] and 15 [7-23]%, compared with 6 [5-7] and 7 [5-10]% in PSV. Inspiratory pressure, positive end-expiratory pressure, and FIO2 changes were adjusted significantly more often with Intellivent compared with PSV. Compared with PSV, Intellivent during a 24-h period improved the PaO2/FIO2 ratio in parallel with more variability in the ventilatory support and more changes in ventilation settings.

  12. 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 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.

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

    Science.gov (United States)

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

    2015-01-01

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

  14. Affective responses in mountain hiking-A randomized crossover trial focusing on differences between indoor and outdoor activity.

    Directory of Open Access Journals (Sweden)

    Martin Niedermeier

    Full Text Available Affective responses during physical activity (PA are important for engagement in PA programs and for adherence to a physically active lifestyle. Little is known about the affective responses to PA bouts lasting longer than 45 minutes. Therefore, the aims of the present study were to analyse acute effects on affective responses of a three-hour outdoor PA intervention (mountain hiking compared to a sedentary control situation and to an indoor treadmill condition.Using a randomized crossover design, 42 healthy participants were randomly exposed to three different conditions: outdoor mountain hiking, indoor treadmill walking, and sedentary control situation (approximately three hours each. Measures included the Feeling Scale, Felt Arousal Scale and a Mood Survey Scale. Repeated measures ANOVAs were used to analyse differences between the conditions.Compared to the control situation, the participants showed a significant increase in affective valence (d = 1.21, p < .001, activation (d = 0.81, p = .004, elation (d = 1.07, p < .001, and calmness (d = 0.84, p = .004, and a significant decrease in fatigue (d = -1.19, p < .001 and anxiety (d = -.79, p < .001 after mountain hiking. Outdoor mountain hiking showed significantly greater positive effects on affective valence, activation, and fatigue compared to indoor treadmill walking.The results indicate that a three-hour PA intervention (mountain hiking elicits higher positive and lower negative affective responses compared to a sedentary control situation and to an indoor PA condition. Outdoor mountain hiking can be recommended by health professionals as a form of PA with the potential to positively influence affective responses.ClinicalTrials.gov NCT02853760. https://clinicaltrials.gov/. Date of registration: 08/02/2016 (retrospectively registered. Date of enrolment of the first participant to the trial: 05/01/2014.

  15. The role of meal viscosity and oat β-glucan characteristics in human appetite control: a randomized crossover trial.

    Science.gov (United States)

    Rebello, Candida J; Chu, Yi-Fang; Johnson, William D; Martin, Corby K; Han, Hongmei; Bordenave, Nicolas; Shi, Yuhui; O'Shea, Marianne; Greenway, Frank L

    2014-05-28

    Foods that enhance satiety can help consumers to resist environmental cues to eat, and improve the nutritional quality of their diets. Viscosity generated by oat β-glucan, influences gastrointestinal mechanisms that mediate satiety. Differences in the source, processing treatments, and interactions with other constituents in the food matrix affect the amount, solubility, molecular weight, and structure of the β-glucan in products, which in turn influences the viscosity. This study examined the effect of two types of oatmeal and an oat-based ready-to-eat breakfast cereal (RTEC) on appetite, and assessed differences in meal viscosity and β-glucan characteristics among the cereals. Forty-eight individuals were enrolled in a randomized crossover trial. Subjects consumed isocaloric breakfast meals containing instant oatmeal (IO), old-fashioned oatmeal (SO) or RTEC in random order at least a week apart. Each breakfast meal contained 218 kcal (150 kcal cereal, and 68 kcal milk) Visual analogue scales measuring appetite were completed before breakfast, and over four hours, following the meal. Starch digestion kinetics, meal viscosities, and β-glucan characteristics for each meal were determined. Appetite responses were analyzed by area under the curve. Mixed models were used to analyze response changes over time. IO increased fullness (p = 0.04), suppressed desire to eat (p = 0.01) and reduced prospective intake (p viscosity, and larger hydration spheres than the RTEC, and IO had greater viscosity after oral and initial gastric digestion (initial viscosity) than the RTEC. IO and SO improved appetite control over four hours compared to RTEC. Initial viscosity of oatmeal may be especially important for reducing appetite.

  16. 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.
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  17. Influence of ambient music on perceived exertion during a pulmonary rehabilitation session: a randomized crossover study.

    Science.gov (United States)

    Reychler, Gregory; Mottart, Florian; Boland, Maelle; Wasterlain, Emmanuelle; Pieters, Thierry; Caty, Gilles; Liistro, Giuseppe

    2015-05-01

    Pulmonary rehabilitation is a key element in the treatment of COPD. Music has been shown to have a positive effect on parameters related to a decrease in exercise tolerance. The aim of this study was to evaluate the effect of listening to ambient music on perceived exertion during a pulmonary rehabilitation session for COPD subjects. COPD subjects randomly performed a session of pulmonary rehabilitation with or without ambient music. Perceived exertion (Borg scales), anxiety (Hospital Anxiety and Depression Scale-Anxiety Subscale), dyspnea (visual analog scale), and cardiorespiratory parameters were compared at the end of both sessions. Forty-one subjects were analyzed. The characteristics of the COPD subjects were as follows: age, 70.5 ± 8.4 y; body mass index, 22.7 ± 3.9 kg/m(2); and FEV1, 38.6 ± 12.5 % predicted. Perceived exertion was not modified by ambient music, but anxiety was improved (P = .02). Dyspnea, fatigue and cardiorespiratory parameters were not influenced by music during a typical session of the pulmonary rehabilitation program. This study demonstrates that perceived exertion during one pulmonary rehabilitation session was not influenced by ambient music. However, a positive effect on anxiety was observed. (ClinicalTrials.gov registration NCT01833260.). Copyright © 2015 by Daedalus Enterprises.

  18. Postexercise Hypotension After Aquatic Exercise in Older Women With Hypertension: A Randomized Crossover Clinical Trial.

    Science.gov (United States)

    Cunha, Raphael M; Costa, Andressa Moura; Silva, Christoffer Novais F; Póvoa, Thais Inácio R; Pescatello, Linda S; Lehnen, Alexandre Machado

    2018-01-12

    Hypertension can be prevented and modified with lifestyle interventions that include regular exercise. Aquatic exercise is widely recommended for older adults for a variety of health benefits, but few studies have assessed the immediate ambulatory blood pressure (BP) response to aquatic exercise, a response termed postexercise hypotension (PEH). Thus, we assessed PEH after a session of aquatic exercise in physically active, older women with hypertension. Twenty-four women 70.0 ± 3.9 years with a resting systolic (SBP)/diastolic (DBP) BP of 124.0/72.3 mm Hg and body mass index of 29.8 ± 4.1 kg/m2 were randomly assigned to participate in a 45-minute session of moderate intensity, water-based exercise (WATER) and a 45-minute land control session (CONTROL). All experimental sessions started at 9 am sharply with 7 days between them. Subjects left the experiments wearing an ambulatory BP monitor for the next 21 hours. SBP was lower by 5.1 ± 1.0 mm Hg after WATER than CONTROL over 21 hours (P Aquatic exercise elicited PEH (~5 mm Hg) over 21 hours, BP reductions that are comparable in magnitude to land aerobic exercise. The immediate antihypertensive benefits of acute aquatic exercise should continue to be explored in future studies.

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

    Science.gov (United States)

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

    2017-09-01

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

  20. Aerobic and combined exercise sessions reduce glucose variability in type 2 diabetes: crossover randomized trial.

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    Franciele R Figueira

    Full Text Available To evaluate the effects of aerobic (AER or aerobic plus resistance exercise (COMB sessions on glucose levels and glucose variability in patients with type 2 diabetes. Additionally, we assessed conventional and non-conventional methods to analyze glucose variability derived from multiple measurements performed with continuous glucose monitoring system (CGMS.Fourteen patients with type 2 diabetes (56±2 years wore a CGMS during 3 days. Participants randomly performed AER and COMB sessions, both in the morning (24 h after CGMS placement, and at least 7 days apart. Glucose variability was evaluated by glucose standard deviation, glucose variance, mean amplitude of glycemic excursions (MAGE, and glucose coefficient of variation (conventional methods as well as by spectral and symbolic analysis (non-conventional methods.Baseline fasting glycemia was 139±05 mg/dL and HbA1c 7.9±0.7%. Glucose levels decreased immediately after AER and COMB protocols by ∼16%, which was sustained for approximately 3 hours. Comparing the two exercise modalities, responses over a 24-h period after the sessions were similar for glucose levels, glucose variance and glucose coefficient of variation. In the symbolic analysis, increases in 0 V pattern (COMB, 67.0±7.1 vs. 76.0±6.3, P = 0.003 and decreases in 1 V pattern (COMB, 29.1±5.3 vs. 21.5±5.1, P = 0.004 were observed only after the COMB session.Both AER and COMB exercise modalities reduce glucose levels similarly for a short period of time. The use of non-conventional analysis indicates reduction of glucose variability after a single session of combined exercises.Aerobic training, aerobic-resistance training and glucose profile (CGMS in type 2 diabetes (CGMS exercise. ClinicalTrials.gov ID: NCT00887094.

  1. Daily consumption of a synbiotic yogurt decreases energy intake but does not improve gastrointestinal transit time: a double-blind, randomized, crossover study in healthy adults

    OpenAIRE

    Tulk, Hilary M. F.; Blonski, Diane C.; Murch, Lauren A; Duncan, Alison M.; Wright, Amanda J.

    2013-01-01

    Objective Probiotic and synbiotic products are widely marketed to healthy individuals, although potential benefits for these individuals are rarely studied. This study investigated the effect of daily consumption of a synbiotic yogurt on gastrointestinal (GI) function in a sample of healthy adults. Subjects/Methods In a randomized crossover double-blind study, 65 healthy adults consumed 200?g/day of yogurt with (synbiotic) or without (control) added probiotics (Bifidobacterium lactis Bb12, La...

  2. Dietary beetroot juice – effects on physical performance in COPD patients: a randomized controlled crossover trial

    Directory of Open Access Journals (Sweden)

    Friis AL

    2017-06-01

    Full Text Available Anne Louise Friis,1,* Carina Bjørnskov Steenholt,1,* Anders Løkke,2 Mette Hansen1 1Section for Sport Science, Department of Public Health, Aarhus University, Denmark; 2Department of Clinical Medicine, Aarhus University, Denmark *These authors contributed equally to this work Background and objective: Dietary beetroot juice (BR supplementation has been shown to reduce the oxygen (O2 consumption of standardized exercise and reduce resting blood pressure (BP in healthy individuals. However, the physiological response of BR in chronic obstructive pulmonary disease (COPD remains controversial. The objective was to test exercise performance in COPD, supplementing with higher doses of BR for a longer duration compared to previous trials in this patient group.Methods: Fifteen COPD patients consumed concentrated BR (2×70 mL twice daily, each containing 300 mg nitrate or placebo (PL (2×70 mL twice daily, nitrate-negligible in a randomized order for 6 consecutive days. On day 7, participants consumed either BR or PL 150 min before testing. BP was measured before completing 6-minute walk test (6MWT and two trials of submaximal cycling. The protocol was repeated after a minimum washout of 7 days.Results: Plasma nitrite concentration was higher in the BR condition compared to PL (P<0.01. There was no difference between the BR and PL conditions regarding the covered distance during the 6MWT (mean ± standard error of the mean: 515±35 m (BR vs 520±38 m (PL, P=0.46, O2 consumption of submaximal exercise (trial 1 P=0.31 vs trial 2 P=0.20, physical activity level (P>0.05, or systolic BP (P=0.80. However, diastolic BP (DBP was reduced after BR ingestion compared to baseline (mean difference: 4.6, 95% CI: 0.1–9.1, P<0.05.Conclusion: Seven days of BR ingestion increased plasma nitrite concentrations and lowered DBP in COPD patients. However, BR did not increase functional walking capacity, O2 consumption during submaximal cycling, or physical activity level

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

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    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.

  4. Fasting and glucose induced thermogenesis in response to three ambient temperatures: a randomized crossover trial in the metabolic syndrome.

    Science.gov (United States)

    Pathak, K; Woodman, R J; James, A P; Soares, M J

    2018-01-11

    Cold exposure increases thermogenesis and could improve insulin sensitivity. We hypothesized a blunted response in the metabolic syndrome (MetS). Twenty older adults 59 ± 10.4 years (with MetS, MetS+, n = 9; without MetS, MetS-, n = 11) completed a randomized crossover design of 3.5 h exposures to 20, 25 and 27 °C on three visits. After an hour's rest at the desired temperature, resting metabolic rate (RMR), respiratory quotient (RQ), forearm to fingertip gradients (FFG), and in the ear temperature (IET) were measured over 30 min. An oral glucose tolerance test followed, and serial measurements were continued for 2 h. Venous blood was sampled for clinical chemistry, irisin, and fibroblast growth factor 21(FGF21). A mixed model ANCOVA adjusted data for age, gender, fat mass, fat-free mass and seasonality. There was a significant MetS×temperature interaction where adjusted RMR was significantly higher in MetS+ compared to MetS- by 12% at 20 °C and by 6% at 25 °C, but similar at 27 °C. FFG increased and IET decreased with decreasing temperature to the same extent in both groups. Fasting irisin and FGF21 did not vary with temperature but the former was significantly higher in MetS-. Adjusted postprandial RQ and insulin to glucose ratios were significantly higher at 20 °C relative to 25 °C. Partial correlation analysis of differences between 27 and 20 °C indicated significant positive relationships between fasting as well as postprandial RQ and the respective changes in irisin and FGF21. There could be an upward shift of the TNZ in MetS+, but this needs reevaluation.

  5. Psyllium supplementation in adolescents improves fat distribution & lipid profile: a randomized, participant-blinded, placebo-controlled, crossover trial.

    Science.gov (United States)

    de Bock, Martin; Derraik, José G B; Brennan, Christine M; Biggs, Janene B; Smith, Greg C; Cameron-Smith, David; Wall, Clare R; Cutfield, Wayne S

    2012-01-01

    We aimed to assess the effects of psyllium supplementation on insulin sensitivity and other parameters of the metabolic syndrome in an at risk adolescent population. This study encompassed a participant-blinded, randomized, placebo-controlled, crossover trial. Subjects were 47 healthy adolescent males aged 15-16 years, recruited from secondary schools in lower socio-economic areas with high rates of obesity. Participants received 6 g/day of psyllium or placebo for 6 weeks, with a two-week washout before crossing over. Fasting lipid profiles, ambulatory blood pressure, auxological data, body composition, activity levels, and three-day food records were collected at baseline and after each 6-week intervention. Insulin sensitivity was measured by the Matsuda method using glucose and insulin values from an oral glucose tolerance test. 45 subjects completed the study, and compliance was very high: 87% of participants took >80% of prescribed capsules. At baseline, 44% of subjects were overweight or obese. 28% had decreased insulin sensitivity, but none had impaired glucose tolerance. Fibre supplementation led to a 4% reduction in android fat to gynoid fat ratio (p = 0.019), as well as a 0.12 mmol/l (6%) reduction in LDL cholesterol (p = 0.042). No associated adverse events were recorded. Dietary supplementation with 6 g/day of psyllium over 6 weeks improves fat distribution and lipid profile (parameters of the metabolic syndrome) in an at risk population of adolescent males. Australian New Zealand Clinical Trials Registry ACTRN12609000888268.

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

    Science.gov (United States)

    Hammami, Muhammad M; Alvi, Syed N

    2017-09-01

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

  7. Chlorthalidone Versus Amlodipine for Hypertension in Kidney Transplant Recipients Treated With Tacrolimus: A Randomized Crossover Trial.

    Science.gov (United States)

    Moes, Arthur D; Hesselink, Dennis A; van den Meiracker, Anton H; Zietse, Robert; Hoorn, Ewout J

    2017-06-01

    Chlorthalidone is a very effective antihypertensive drug, but it has not been studied prospectively in kidney transplant recipients with hypertension. Recent data indicate that calcineurin inhibitors activate the thiazide-sensitive sodium chloride cotransporter, providing further rationale to test thiazides in this population. Randomized noninferiority crossover trial (noninferiority margin, -2.8mmHg). Hypertensive kidney transplant recipients using tacrolimus (median duration, 2.4 years after transplantation; mean estimated glomerular filtration rate, 63±27 [SD] mL/min/1.73m 2 ; mean systolic blood pressure [SBP], 151±12mmHg). Amlodipine (5-10mg) and chlorthalidone (12.5-25mg) for 8 weeks (separated by 2-week washout). Average daytime (9 am to 9 pm) ambulatory SBP. Blood pressure and laboratory parameters. 88 patients underwent ambulatory blood pressure monitoring, of whom 49 (56%) with average daytime SBP>140mmHg were enrolled. 41 patients completed the study. Amlodipine and chlorthalidone both reduced ambulatory SBP after 8 weeks (mean changes of 150±12 to 137±12 [SD] vs 151±12 to 141±13mmHg; effect size, -4.2 [95% CI, -7.3 to 1.1] mmHg). Despite these similar blood pressure responses, chlorthalidone reduced proteinuria by 30% (effect size, -65 [95% CI, -108 to -35] mg/g) and also reduced physician-assessed peripheral edema (22% to 10%; P<0.05 for both). In contrast, chlorthalidone temporarily reduced kidney function and increased both serum uric acid and glycated hemoglobin levels. Open-label design, short follow-up, per-protocol analysis. Chlorthalidone is an antihypertensive drug equally effective as amlodipine after kidney transplantation. Copyright © 2017 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

  8. Effect of ischemic preconditioning in skeletal muscle measured by functional magnetic resonance imaging and spectroscopy: a randomized crossover trial

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    Bartko Johann

    2011-06-01

    Full Text Available Abstract Background Nuclear magnetic resonance (NMR imaging and spectroscopy have been applied to assess skeletal muscle oxidative metabolism. Therefore, in-vivo NMR may enable the characterization of ischemia-reperfusion injury. The goal of this study was to evaluate whether NMR could detect the effects of ischemic preconditioning (IPC in healthy subjects. Methods Twenty-three participants were included in two randomized crossover protocols in which the effects of IPC were measured by NMR and muscle force assessments. Leg ischemia was administered for 20 minutes with or without a subsequent impaired reperfusion for 5 minutes (stenosis model. IPC was administered 4 or 48 hours prior to ischemia. Changes in 31phosphate NMR spectroscopy and blood oxygen level-dependent (BOLD signals were recorded. 3-Tesla NMR data were compared to those obtained for isometric muscular strength. Results The phosphocreatine (PCr signal decreased robustly during ischemia and recovered rapidly during reperfusion. In contrast to PCr, the recovery of muscular strength was slow. During post-ischemic stenosis, PCr increased only slightly. The BOLD signal intensity decreased during ischemia, ischemic exercise and post-ischemic stenosis but increased during hyperemic reperfusion. IPC 4 hours prior to ischemia significantly increased the maximal PCr reperfusion signal and mitigated the peak BOLD signal during reperfusion. Conclusions Ischemic preconditioning positively influenced muscle metabolism during reperfusion; this resulted in an increase in PCr production and higher oxygen consumption, thereby mitigating the peak BOLD signal. In addition, an impairment of energy replenishment during the low-flow reperfusion was detected in this model. Thus, functional NMR is capable of characterizing changes in reperfusion and in therapeutic interventions in vivo. Trial Registration ClinicalTrials.gov: NCT00883467

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

    Science.gov (United States)

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

    2014-06-28

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

  10. Effect of Peripheral Electrical Stimulation (PES on Nocturnal Blood Glucose in Type 2 Diabetes: A Randomized Crossover Pilot Study.

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    Merav Catalogna

    Full Text Available Regulation of hepatic glucose production has been a target for antidiabetic drug development, due to its major contribution to glucose homeostasis. Previous pre-clinical study demonstrated that peripheral electrical stimulation (PES may stimulate glucose utilization and improve hepatic insulin sensitivity. The aim of the present study was to evaluate safety, tolerability, and the glucose-lowering effect of this approach in patients with type 2 diabetes (T2DM.Twelve patients with T2DM were recruited for an open label, interventional, randomized trial. Eleven patients underwent, in a crossover design, an active, and a no-intervention control periods, separated with a two-week washout phase. During the active period, the patients received a daily lower extremity PES treatment (1.33Hz/16Hz burst mode, for 14 days. Study endpoints included changes in glucose levels, number of hypoglycemic episodes, and other potential side effects. Endpoints were analyzed based on continuous glucose meter readings, and laboratory evaluation.We found that during the active period, the most significant effect was on nocturnal glucose control (P < 0.0004, as well as on pre-meal mean glucose levels (P < 0.02. The mean daily glucose levels were also decreased although it did not reach clinical significance (P = 0.07. A reduction in serum cortisol (P < 0.01 but not in insulin was also detected after 2 weeks of treatment. No adverse events were recorded.These results indicate that repeated PES treatment, even for a very short duration, can improve blood glucose control, possibly by suppressing hepatic glucose production. This effect may be mediated via hypothalamic-pituitary-adrenal axis modulation.ClinicalTrials.gov NCT02727790.

  11. Clinical efficacy and safety of mirabegron and imidafenacin in women with overactive bladder: A randomized crossover study (the MICRO study).

    Science.gov (United States)

    Torimoto, Kazumasa; Matsushita, Chie; Yamada, Atsushi; Goto, Daisuke; Matsumoto, Yoshihiro; Hosokawa, Yukinari; Miyake, Makito; Aoki, Katsuya; Hirayama, Akihide; Tanaka, Nobumichi; Fujimoto, Kiyohide

    2017-04-01

    We aimed to compare the efficacy and safety of mirabegron, a β3-adrenoceptor agonist, and imidafenacin, an anticholinergic agent, in overactive bladder patients. We conducted a multicenter, prospective randomized cross-over study at 5 hospitals in Japan from December 2012 to June 2015. We enrolled female patients with overactive bladder aged ≥50 years, who had never received treatment for the condition. The patients were assigned to Group A or B. Group A patients were administered mirabegron (50 mg per day) for 8 weeks, followed by a 2-week washout period, and then imidafenacin (0.2 mg per day) for 8 weeks. This order of drug administration was reversed in Group B. A total of 33 and 18 patients in Group A and 37 and 26 patients in Group B continued to receive treatment at weeks 8 and 18, respectively. Mirabegron administration significantly improved overactive bladder symptom score (OABSS), the urinary frequency per 24 hr, voided volume per micturition, and number of nocturia episodes per night at week 8. Moreover, imidafenacin administration improved all these variables, except for the number of nocturia episodes per night at week 8. No significant difference was observed in the drug effects between mirabegron and imidafenacin. Although imidafenacin administration significantly increased the scores for dry mouth, blurred vision, and constipation, mirabegron administration did not. Mirabegron and imidafenacin have the same efficacy. Imidafenacin administration is associated with a higher rate of dry mouth, blurred vision, and constipation as compared to mirabegron administration. Neurourol. Urodynam. 36:1097-1103, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  12. Psyllium supplementation in adolescents improves fat distribution & lipid profile: a randomized, participant-blinded, placebo-controlled, crossover trial.

    Directory of Open Access Journals (Sweden)

    Martin de Bock

    Full Text Available AIMS: We aimed to assess the effects of psyllium supplementation on insulin sensitivity and other parameters of the metabolic syndrome in an at risk adolescent population. METHODS: This study encompassed a participant-blinded, randomized, placebo-controlled, crossover trial. Subjects were 47 healthy adolescent males aged 15-16 years, recruited from secondary schools in lower socio-economic areas with high rates of obesity. Participants received 6 g/day of psyllium or placebo for 6 weeks, with a two-week washout before crossing over. Fasting lipid profiles, ambulatory blood pressure, auxological data, body composition, activity levels, and three-day food records were collected at baseline and after each 6-week intervention. Insulin sensitivity was measured by the Matsuda method using glucose and insulin values from an oral glucose tolerance test. RESULTS: 45 subjects completed the study, and compliance was very high: 87% of participants took >80% of prescribed capsules. At baseline, 44% of subjects were overweight or obese. 28% had decreased insulin sensitivity, but none had impaired glucose tolerance. Fibre supplementation led to a 4% reduction in android fat to gynoid fat ratio (p = 0.019, as well as a 0.12 mmol/l (6% reduction in LDL cholesterol (p = 0.042. No associated adverse events were recorded. CONCLUSIONS: Dietary supplementation with 6 g/day of psyllium over 6 weeks improves fat distribution and lipid profile (parameters of the metabolic syndrome in an at risk population of adolescent males. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12609000888268.

  13. Effects of inhaled nitric oxide on hemostasis in healthy adults treated with heparin: a randomized, controlled, blinded crossover study

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    Goldstein Brahm

    2012-01-01

    Full Text Available Abstract Background Effects of nitric oxide (NO on hemostasis have been studied in various investigational settings, but data regarding inhaled NO on bleeding and platelet function are conflicting. It is not known if inhaled NO has an effect when administered with drugs that influence hemostasis. This trial evaluated effects of inhaled NO on hemostasis in the presence of heparin using aspirin as a positive control. Patients/Methods Twelve healthy adult males were enrolled in a single-center, randomized, single-blind, four-way crossover trial. Subjects received 80 ppm NO or medical air (placebo inhalation for 30 min with simultaneous injection of placebo or heparin. Aspirin capsules were used as a positive control. Parameters of hemostasis were measured before treatment and at post-treatment intervals. Results Activated clotting time (ACT, prothrombin time (PT and activated partial thromboplastin time (aPTT increased only in groups that received heparin. Areas under the curve for ACT in heparin groups receiving inhaled NO were judged to be equivalent to those receiving medical air for both 0- to 4-h (ratio: 1.00; 90% CI, 0.90-1.11 and 0- to 24-h time intervals (ratio: 1.01; 90% CI, 0.92-1.12. Changes in bleeding time and platelet aggregation were observed only in aspirin groups. No clinically significant changes in hemoglobin, red blood cell counts or haematocrit were observed in any group. Conclusions Inhaled NO, when administered with heparin, exhibited no significant additive effects on ACT, PT, aPTT, bleeding time or platelet aggregation.

  14. Efficacy of methylphenidate in children with attention-deficit hyperactivity disorder and learning disabilities: a randomized crossover trial.

    Science.gov (United States)

    Grizenko, Natalie; Bhat, Mamatha; Schwartz, George; Ter-Stepanian, Marina; Joober, Ridha

    2006-01-01

    To determine whether children with attention-deficit hyperactivity disorder (ADHD) and learning disabilities respond differently to methylphenidate (MPH) compared with children with ADHD only. We conducted a prospective, double-blind, placebo-controlled, randomized, 2-week crossover trial of MPH, during which response to MPH was assessed. Learning ability was appraised using the Wide Range Achievement Test, Revised (WRAT-R), for English-speaking students and the Test de rendement pour francophones for French-speaking students. The study was conducted at the Douglas Hospital, a McGill University-affiliated teaching hospital in Montréal. Ninety-five children, aged 6-12 years, who met the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV), criteria for ADHD participated in the study, which ran from 2001 to 2004. The outcome measure used was the Consensus Clinical Response, an indicator of the degree of clinical improvement shown when taking MPH. The proportion of children with learning disabilities who responded to MPH (55%) was significantly smaller (chi(2)1 = 4.5, p = 0.034) than the proportion of children without learning disabilities who responded adequately to MPH (75%). This difference was mainly because of children with mathematics disability being particularly unresponsive to MPH (chi(2)1 = 4.5, p = 0.034). Children with reading disability did not show this pattern of poor response (chi(2)1 = 1.0, p = 0.33). Children with ADHD and comorbid learning disability tended to respond more poorly to MPH. In particular, children with disability in mathematics responded less to MPH than those without disability in mathematics. Additional therapy may be indicated for this group of patients.

  15. Improving ultrasonic measurement of diaphragmatic excursion after cardiac surgery using the anatomical M-mode: a randomized crossover study.

    Science.gov (United States)

    Pasero, Daniela; Koeltz, Adrien; Placido, Rui; Fontes Lima, Mariana; Haun, Olivia; Rienzo, Mario; Marrache, David; Pirracchio, Romain; Safran, Denis; Cholley, Bernard

    2015-04-01

    Motion-mode (MM) echography allows precise measurement of diaphragmatic excursion when the ultrasound beam is parallel to the diaphragmatic displacement. However, proper alignment is difficult to obtain in patients after cardiac surgery; thus, measurements might be inaccurate. A new imaging modality named the anatomical motion-mode (AMM) allows free placement of the cursor through the numerical image reconstruction and perfect alignment with the diaphragmatic motion. Our goal was to compare MM and AMM measurements of diaphragmatic excursion in cardiac surgical patients. Cardiac surgical patients were studied after extubation. The excursions of the right and left hemidiaphragms were measured by two operators, an expert and a trainee, using MM and AMM successively, according to a blinded, randomized, crossover sequence. Values were averaged over three consecutive respiratory cycles. The angle between the MM and AMM cursors was quantified for each measurement. Fifty patients were studied. The mean (±SD) angle between the MM and AMM cursors was 37° ± 16°. The diaphragmatic excursion as measured by experts was 1.8 ± 0.7 cm using MM and 1.5 ± 0.5 cm using AMM (p AMM in 75 % of the measurements. Bland-Altman analysis showed tighter limits of agreement between experts and trainees with AMM [bias: 0.0 cm; 95 % confidence interval (CI): 0.8 cm] than with MM (bias: 0.0 cm; 95 % CI: 1.4 cm). MM overestimates diaphragmatic excursion in comparison to AMM in cardiac surgical patients. Using MM may lead to a lack of recognition of diaphragmatic dysfunction.

  16. Does a reduced glucose intake prevent hyperglycemia in children early after cardiac surgery? a randomized controlled crossover study

    Science.gov (United States)

    2012-01-01

    Introduction Hyperglycemia in children after cardiac surgery can be treated with intensive insulin therapy, but hypoglycemia is a potential serious side effect. The aim of this study was to investigate the effects of reducing glucose intake below standard intakes to prevent hyperglycemia, on blood glucose concentrations, glucose kinetics and protein catabolism in children after cardiac surgery with cardiopulmonary bypass (CPB). Methods Subjects received a 4-hour low glucose (LG; 2.5 mg/kg per minute) and a 4-hour standard glucose (SG; 5.0 mg/kg per minute) infusion in a randomized blinded crossover setting. Simultaneously, an 8-hour stable isotope tracer protocol was conducted to determine glucose and leucine kinetics. Data are presented as mean ± SD or median (IQR); comparison was made by paired samples t test. Results Eleven subjects (age 5.1 (20.2) months) were studied 9.5 ± 1.9 hours post-cardiac surgery. Blood glucose concentrations were lower during LG than SG (LG 7.3 ± 0.7 vs. SG 9.3 ± 1.8 mmol/L; P glucose production was higher during LG than SG (LG 2.9 ± 0.8 vs. SG 1.5 ± 1.1 mg/kg per minute; P = 0.02), due to increased glycogenolysis (LG 1.0 ± 0.6 vs. SG 0.0 ± 1.0 mg/kg per minute; P glucose intake (LG -54.8 ± 14.6 vs. SG -58.8 ± 16.7 μmol/kg per hour; P = 0.57). Conclusions Currently recommended glucose intakes aggravated hyperglycemia in children early after cardiac surgery with CPB. Reduced glucose intake decreased blood glucose concentrations without causing hypoglycemia or affecting protein catabolism, but increased glycogenolysis. Trial registration Dutch trial register NTR2079. PMID:23031354

  17. Effects of non-fat dairy products added to the routine diet on vascular function: a randomized controlled crossover trial.

    Science.gov (United States)

    Machin, D R; Park, W; Alkatan, M; Mouton, M; Tanaka, H

    2015-04-01

    High consumption of low- and non-fat dairy products is associated with reduced risk of high blood pressure (BP) and central arterial stiffness. However, interventional studies to determine if the addition of non-fat dairy products to the diet is capable of reducing central BP and improving vascular function are lacking. The aim of this study was to determine if the solitary addition of non-fat dairy products to the normal routine diet would reduce central BP and improve vascular function in middle-aged and older adults with elevated BP. Using a randomized, crossover intervention study design, forty-nine adults (44% men, 53 ± 2 years, 170 ± 2 cm, 88 ± 3 kg; mean ± SEM) with elevated BP (134 ± 1/81 ± 1 mm Hg) underwent a High Dairy condition (+4 servings/day of conventional non-fat dairy products) and No Dairy condition (+4 servings/day fruit products) in which all dairy products were removed. Both dietary conditions lasted 4 weeks with a 2-week washout before crossing over into the alternate condition. The High Dairy condition produced reductions in central systolic BP (-3 ± 1 mm Hg) and carotid-femoral pulse wave velocity (-0.5 ± 0.1 m/sec), with a concomitant increase in brachial flow-mediated dilation (+1.1 ± 0.4%) and cardiovagal baroreflex sensitivity (+5 ± 1 ms/mm Hg) (P Dairy condition, brachial flow-mediated dilation was reduced (-1.0 ± 0.1%, P dairy products in the normal routine diet modulates levels of central BP and vascular function in middle-aged and older adults with elevated BP. clinicaltrials.gov Identifier: NCT01577030. Copyright © 2015 Elsevier B.V. All rights reserved.

  18. Intake of kale suppresses postprandial increases in plasma glucose: A randomized, double-blind, placebo-controlled, crossover study.

    Science.gov (United States)

    Kondo, Sumio; Suzuki, Asahi; Kurokawa, Mihoko; Hasumi, Keiji

    2016-11-01

    Kale (Brassica oleracea var. acephala), a vegetable in the family Brassicaceae, has beneficial effects on health, including hypoglycemic effects. In our previous study with a limited number of subjects, intake of kale-containing food at a dose of 14 g decreased postprandial plasma glucose levels. In the present study, the effective dose of kale-containing food was investigated in a randomized, double-blind, placebo-controlled, crossover trial. The trial was conducted on 42 Japanese subjects aged 21-64 years with fasting plasma glucose levels of ≤125 mg/dl and 30-min postprandial plasma glucose levels of 140-187 mg/dl. The subjects consumed placebo or kale-containing food [7 or 14 g; low-dose (active-L) or high-dose (active-H) kale, respectively] together with a high-carbohydrate meal. At 30-120 min after the test meal intake, the plasma levels of glucose and insulin were determined. The postprandial plasma glucose levels in subjects with intake of active-L or active-H were significantly lower than those in subjects with intake of placebo, with the maximum plasma concentration (Cmax; 163±24 mg/dl for active-L and 162±23 mg/dl for active-H compared with 176±26 mg/dl for placebo [values presented as means ± standard deviation (SD); Pkale were observed. Our findings suggest that intake of kale suppresses postprandial increases in plasma glucose levels at a single dose of 7 g, and that a dose as high as 14 g is safe.

  19. Acute and second-meal effects of almond form in impaired glucose tolerant adults: a randomized crossover trial

    Directory of Open Access Journals (Sweden)

    Considine Robert V

    2011-01-01

    Full Text Available Abstract Background Nut consumption may reduce the risk of developing type 2 diabetes. The aim of the current study was to measure the acute and second-meal effects of morning almond consumption and determine the contribution of different nut fractions. Methods Fourteen impaired glucose tolerant (IGT adults participated in a randomized, 5-arm, crossover design study where whole almonds (WA, almond butter (AB, defatted almond flour (AF, almond oil (AO or no almonds (vehicle - V were incorporated into a 75 g available carbohydrate-matched breakfast meal. Postprandial concentrations of blood glucose, insulin, non-esterified free fatty acids (NEFA, glucagon-like peptide-1 (GLP-1 and appetitive sensations were assessed after treatment breakfasts and a standard lunch. Results WA significantly attenuated second-meal and daylong blood glucose incremental area under the curve (AUCI and provided the greatest daylong feeling of fullness. AB and AO decreased blood glucose AUCI in the morning period and daylong blood glucose AUCI was attenuated with AO. WA and AO elicited a greater second-meal insulin response, particularly in the early postprandial phase, and concurrently suppressed the second-meal NEFA response. GLP-1 concentrations did not vary significantly between treatments. Conclusions Inclusion of almonds in the breakfast meal decreased blood glucose concentrations and increased satiety both acutely and after a second-meal in adults with IGT. The lipid component of almonds is likely responsible for the immediate post-ingestive response, although it cannot explain the differential second-meal response to AB versus WA and AO.

  20. The haemodynamic effects of intravenous paracetamol (acetaminophen) in healthy volunteers: a double-blind, randomized, triple crossover trial.

    Science.gov (United States)

    Chiam, Elizabeth; Weinberg, Laurence; Bailey, Michael; McNicol, Larry; Bellomo, Rinaldo

    2016-04-01

    The haemodynamic effects of intravenous paracetamol have not been systematically investigated. We compared the physiological effects of intravenous mannitol-containing paracetamol, and an equivalent dosage of mannitol, and normal saline 0.9% in healthy volunteers. We performed a blinded, triple crossover, randomized trial of 24 adult healthy volunteers. Participants received i.v. paracetamol (1 g paracetamol +3.91 g mannitol 100 ml(-1) ), i.v. mannitol (3.91 g mannitol 100 ml(-1) ) and i.v. normal saline (100 ml). Composite primary end points were changes in mean arterial pressure (MAP), systolic blood pressure (SBP) and diastolic blood pressure (DBP) measured pre-infusion, during a 15 min infusion period and over a 45 min observation period. Systemic vascular resistance index (SVRI) and cardiac index were measured at the same time points. Infusion of paracetamol induced a transient yet significant decrease in blood pressures from pre-infusion values (MAP -1.85 mmHg, 95% CI -2.6, -1.1, SBP -0.54 mmHg, 95% CI -1.7, 0.6 and DBP -1.92 mmHg, 95% CI -2.6, -1.2, P paracetamol caused a transient decrease in blood pressure immediately after infusion. These effects were not seen with mannitol or normal saline. The physiological mechanism was consistent with vasodilatation. This study provides plausible physiological data in a healthy volunteer setting, supporting transient changes in haemodynamic variables with i.v. paracetamol and justifies controlled studies in the peri-operative and critical care setting. © 2015 The British Pharmacological Society.

  1. The haemodynamic effects of intravenous paracetamol (acetaminophen) in healthy volunteers: a double‐blind, randomized, triple crossover trial

    Science.gov (United States)

    Chiam, Elizabeth; Bailey, Michael; McNicol, Larry; Bellomo, Rinaldo

    2016-01-01

    Aim The haemodynamic effects of intravenous paracetamol have not been systematically investigated. We compared the physiological effects of intravenous mannitol‐containing paracetamol, and an equivalent dosage of mannitol, and normal saline 0.9% in healthy volunteers. Methods We performed a blinded, triple crossover, randomized trial of 24 adult healthy volunteers. Participants received i.v. paracetamol (1 g paracetamol +3.91 g mannitol 100 ml–1), i.v. mannitol (3.91 g mannitol 100 ml–1) and i.v. normal saline (100 ml). Composite primary end points were changes in mean arterial pressure (MAP), systolic blood pressure (SBP) and diastolic blood pressure (DBP) measured pre‐infusion, during a 15 min infusion period and over a 45 min observation period. Systemic vascular resistance index (SVRI) and cardiac index were measured at the same time points. Results Infusion of paracetamol induced a transient yet significant decrease in blood pressures from pre‐infusion values (MAP –1.85 mmHg, 95% CI –2.6, –1.1, SBP –0.54 mmHg, 95% CI –1.7, 0.6 and DBP −1.92 mmHg, 95% CI –2.6, –1.2, P paracetamol caused a transient decrease in blood pressure immediately after infusion. These effects were not seen with mannitol or normal saline. The physiological mechanism was consistent with vasodilatation. This study provides plausible physiological data in a healthy volunteer setting, supporting transient changes in haemodynamic variables with i.v. paracetamol and justifies controlled studies in the peri‐operative and critical care setting. PMID:26606263

  2. CPR PRO® device reduces rescuer fatigue during continuous chest compression cardiopulmonary resuscitation: a randomized crossover trial using a manikin model.

    Science.gov (United States)

    Kovic, Ivor; Lulic, Dinka; Lulic, Ileana

    2013-10-01

    The performance of high-quality chest compressions with minimal interruptions is one of the most important elements of the "Chain of Survival." To evaluate the impact of a novel CPR PRO(®) (CPRO) device for manual chest compression on rescuer fatigue, pain, and cardiopulmonary resuscitation (CPR) quality. Randomized crossover trial of 24 health care professionals performing continuous chest compression CPR for 10 min with a CPRO device and conventional manual CPR (MCPR). Data about chest compressions were recorded using a manikin. Rescuers' physiologic signs were recorded before and after each session, and heart rate (HR) data were tracked continuously. Fatigue was assessed with ratings of perceived exertion, and pain questionnaire. All subjects completed 10 min of CPR with both methods. Significantly more rest breaks were taken during MCPR sessions (1.7 ± 2 vs. 0.21 ± 0.72). Subjects' perceived exertion was higher after MCPR, as well as the average (120.7 ± 16.8 vs. 110.8 ± 17.6) and maximal HR (134.3 ± 18.5 vs. 123.42 ± 16.5) during testing. Subjects reported more pain in the hands, especially the wrist, after performing MCPR. Average depth of compressions was higher with the CPRO device (4.6 ± 7.0 vs. 4.3 ± 7.9) and declined more slowly over time. Other CPR quality parameters, such as the correct position and complete release of pressure, were also better for CPRO CPR. CPRO device reduces rescuer fatigue and pain during continuous chest compression CPR, which results in a higher quality of CPR in a simulation setting. Copyright © 2013 Elsevier Inc. All rights reserved.

  3. 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

  4. A randomized, crossover study to evaluate the pharmacokinetics of amantadine and oseltamivir administered alone and in combination.

    Directory of Open Access Journals (Sweden)

    Dennis Morrison

    2007-12-01

    Full Text Available The threat of potential pandemic influenza requires a reevaluation of licensed therapies for the prophylaxis or treatment of avian H5N1 infection that may adapt to man. Among the therapies considered for use in pandemic influenza is the co-administration of ion channel and neuraminidase inhibitors, both to potentially increase efficacy as well as to decrease the emergence of resistant isolates. To better understand the potential for drug interactions, a cross-over, randomized, open-label trial was conducted with amantadine, 100 mg po bid, and oseltamivir, 75 mg po bid, given alone or in combination for 5 days. Each subject (N = 17 served as their own control and was administered each drug alone or in combination, with appropriate wash-out. Co-administration with oseltamivir had no clinically significant effect on the pharmacokinetics (PK of amantadine [mean ratios (90% CI for AUC(0-12 0.93 (0.89, 0.98 and C(max 0.96 (0.90, 1.02]. Similarly, amantadine co-administration did not affect oseltamivir PK [AUC(0-12 0.92 (0.86, 0.99 and C(max 0.85 (0.73, 0.99] or the PK of the metabolite, oseltamivir carboxylate [AUC(0-12 0.98 (0.95, 1.02 and C(max 0.95 (0.89, 1.01]. In this small trial there was no evidence of an increase in adverse events. Although many more subjects would need to be studied to rule out a synergistic increase in adverse events, the combination in this small human drug-drug interaction trial appears safe and without pharmacokinetic consequences.ClinicalTrials.gov NCT00416962.

  5. Comparison of Xenon with LED illuminant in difficult and inhalation injury airway scenario: A randomized crossover manikin study.

    Science.gov (United States)

    Moritz, Andreas; Prottengeier, Johannes; Schmidt, Joachim

    2017-11-01

    The purpose of this study was to compare the effectiveness of a Xenon halogen with a light-emitting diode (LED) laryngoscope light handle in a difficult airway scenario, as well as in an inhalation injury airway scenario that combines a difficult airway and a limited view. We recruited forty-two anesthetists into a randomized crossover trial. Each performed tracheal intubation (TI) with a Xenon halogen and a LED light handle in the two manikin scenarios. The primary endpoint was the "time to intubate". Other endpoints were the "time to vocal cords", the "time to ventilate", the rate of successful intubation, the number of intubation attempts, the Cormack-Lehane score, the number of optimization maneuvers, the number of audible dental click sounds indicating dental damage and subjective impressions. In the difficult airway scenario, no significant differences in the recorded intubation times were observed. In the inhalation injury airway scenario, the intubation times were significantly shorter using the LED light handle. Regarding the subjective values, the LED illuminant enabled a significant better view and illumination of the oropharyngeal space and the vocal cords, in both manikin scenarios. The LED laryngoscope light handle did not affect the recorded intubation times in the simulated difficult airway scenario, but provided significant advantages in the inhalation injury airway scenario that combines a difficult airway with a limited view caused by a sooted pharynx. We therefore hypothesize, that the LED illuminant might be beneficial in the airway management of burn patients with severe inhalation injury. Copyright © 2017 Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2017-01-01

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

  7. Urtica dioica for treatment of benign prostatic hyperplasia: a prospective, randomized, double-blind, placebo-controlled, crossover study.

    Science.gov (United States)

    Safarinejad, Mohammad Reza

    2005-01-01

    To determine the effects of therapy with Urtica dioica for symptomatic relief of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). A 6-month, double-blind, placebo-controlled, randomized, partial crossover, comparative trial of Urtica dioica with placebo in 620 patients was conducted. Patients were evaluated using the International Prostate Symptom Score (IPSS), the maximum urinary flow rate (Qmax), postvoid residual urine volume (PVR), Serum Prostatic- Specific Antigen (PSA), testosterone levels, and prostate size. At the end of 6-month trial, unblinding revealed that patients who initially received the placebo were switched to Urtica dioica. Both groups continued the medication up to 18 months. 558 patients (90%) completed the study (287/305, 91% in the Urtica dioica group, and 271/315, 86% in the placebo group). By intention- to-treat analysis, at the end of 6-month trial, 232 (81%) of 287 patients in the Urtica dioica group reported improved LUTS compared with 43 (16%) of 271 patients in the placebo group (P Urtica dioica and from 19.2 to 17.7 with placebo (P = 0.002). Peak flow rates improved by 3.4 mL/s for placebo recipients and by 8.2 mL/s for treated patients (P Urtica dioica group, PVR decreased from an initial value of 73 to 36 mL (P Urtica dioica group (from 40.1 cc initially to 36.3 cc; P effects were identified in either group. In the present study, Urtica dioica have beneficial effects in the treatment of symptomatic BPH. Further clinical trials should be conducted to confirm these results before concluding that Urtica dioica is effective.

  8. Nutraceutical approach to moderate cardiometabolic risk: results of a randomized, double-blind and crossover study with Armolipid Plus.

    Science.gov (United States)

    Ruscica, Massimiliano; Gomaraschi, Monica; Mombelli, Giuliana; Macchi, Chiara; Bosisio, Raffaella; Pazzucconi, Franco; Pavanello, Chiara; Calabresi, Laura; Arnoldi, Anna; Sirtori, Cesare R; Magni, Paolo

    2014-01-01

    Primary cardiovascular prevention may be achieved by lifestyle/nutrition improvements and specific drugs, although a relevant role is now emerging for specific functional foods and nutraceuticals. The aim of this study was to evaluate the usefulness of a nutraceutical multitarget approach in subjects with moderate cardiovascular risk and to compare it with pravastatin treatment. Thirty patients with moderate dyslipidemia and metabolic syndrome (according to the Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults) were included in an 8-week randomized, double-blind crossover study and took either placebo or a nutraceutical combination that contained red yeast rice extract, berberine, policosanol, astaxanthin, coenzyme Q10, and folic acid (Armolipid Plus). Subsequently, they were subjected to another 8-week treatment with pravastatin 10 mg/d. This dosage was selected on the basis of its expected -20% efficacy in reducing low-density lipoprotein-cholesterol. Treatment with Armolipid Plus led to a significant reduction of total cholesterol (-12.8%) and low-density lipoprotein-cholesterol (-21.1%), similar to pravastatin (-16% and -22.6%, respectively), and an increase of high-density lipoprotein-cholesterol (4.8%). Armolipid Plus improved the leptin-to-adiponectin ratio, whereas adiponectin levels were unchanged. These results indicate that this nutraceutical approach shows a lipid-lowering activity comparable to pravastatin treatment. Hence, it may be a safe and useful option, especially in conditions of moderate cardiovascular risk, in which a pharmacologic intervention may not be appropriate. Copyright © 2014 National Lipid Association. Published by Elsevier Inc. All rights reserved.

  9. GASTRIC RESIDUAL VOLUME BY MAGNETIC RESSONANCE AFTER INTAKE OF MALTODEXTRIN AND GLUTAMINE: a randomized double-blind, crossover study

    Directory of Open Access Journals (Sweden)

    Luigi R BRIANEZ

    2014-06-01

    Full Text Available ContextThe addition of glutamine in preoperative drinks may enhance the benefits of carbohydrate alone.ObjectivesTo evaluate the gastric residual volume after the intake of a beverage containing carbohydrate plus glutamine.MethodsEleven healthy volunteers (24-30 years-old were randomized in a crossover fashion to intake 400 mL (4h before and 200 mL (2h before of a beverage containing either 12.5% maltodextrin (carbohydrate group or 12.5% maltodextrin plus 15 g of glutamine (glutamine group in two different moments 7 days apart. Magnetic ressonance was performed to measure the gastric residual volume (mL 120 and 180 minutes after the last ingestion.ResultsGastric residual volume similar to basal condition was found after 2h and 3h of the intake of beverages. There was no difference in the mean ±SD GRV (mL found at 120 minutes (carbohydrate group: 22.9±16.6 and glutamine group: 19.7±10.7 and at 180 minutes (carbohydrate group: 21.5±24.1 and glutamine group: 15.1±10.1 between the two drinks.ConclusionsGastric emptying is efficient, and occurs in up to two hours after the intake of a beverage containing either carbohydrate alone or carbohydrate associated with glutamine. The addition of glutamine to carbohydrate-enriched drink seems to be safe for the use up to 2h before an operation. HEADINGS - Gastric emptying. Preoperative care. Carbohydrates. Glutamine. Magnetic resonance imaging.

  10. A randomized crossover trial on the effect of compression stockings on nausea and vomiting in early pregnancy.

    Science.gov (United States)

    Mendoza, Erika; Amsler, Felix

    2017-01-01

    This study aimed to assess the impact of wearing compression stockings on women's quality of life (QoL) associated with nausea and vomiting in early pregnancy (NVP). In this randomized, open, single-center, crossover study, 74 women were assigned 1:1 to 2 weeks with compression stockings followed by 2 weeks without or vice versa. The main outcomes were NVP-associated QoL, leg-related QoL, and dizziness, as assessed by the Nausea and Vomiting in Pregnancy Quality of Life (NVPQOL) questionnaire, Chronic Venous Disease Quality of Life (CIVIQ) questionnaire, and questions on dizziness at baseline and after each 2-week period, respectively. Daily NVP was assessed using the modified Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) questionnaire. Data were analyzed using Pearson's chi-square and independent t-tests. Fifty-eight women completed the study. QoL scores improved with compression treatment; changes in mean total scores were as follows: NVPQOL, -36.7 with compression vs -21.7 without (P<0.0001); and CIVIQ, -4.5 with compression vs +1.4 without (P=0.001). Mean dizziness scores were -3.2 with compression vs -0.4 without (P<0.0001). PUQE mean total score (standard deviation) was 4.9 (2.3) with compression vs 5.5 (2.2) without (P=0.042). Wearing of compression stockings in early pregnancy may improve nausea and vomiting-associated symptoms in addition to improving QoL factors.

  11. Efficacy of osteopathic manipulative treatment for low back pain in euhydrated and hypohydrated conditions: a randomized crossover trial.

    Science.gov (United States)

    Parker, Justine; Heinking, Kurt P; Kappler, Robert E

    2012-05-01

    Low back pain (LBP) affects up to 85% of all persons at some time in life and is a condition for which osteopathic manipulative treatment (OMT) has been shown to be beneficial. Measures that can improve the efficacy of OMT would further benefit patients; one such measure, hydration status, was explored in this study. To determine whether there is a relationship between a patient's hydration status before OMT for LBP and the outcome of that treatment. A randomized, single-blind crossover study conducted from March to December 2010. Outpatient academic center. Eight women and 11 men with LBP of 1 to 12 months duration. Both euhydrated and hypohydrated conditions were achieved in each participant by modifying water consumption for 36 hours before OMT sessions. PARTICIPANTS received 2 sessions of OMT, each in a different hydration condition and with a 1-week washout period in between. Pre- and posttreatment visual analog scale scores for pain, number and severity of somatic dysfunction as scored on the somatic dysfunction severity scale, and number of asymmetric landmarks found on the osteopathic standing structural examination. Improvements in total and severe number of lumbar somatic dysfunction (P=.001 and P=.013, respectively) and number of asymmetric landmarks on standing structural examination (P=.002) were found to be greater in the euhydrated vs the hypohydrated condition. PARTICIPANTS had a mean of 2 fewer areas of posttreatment somatic dysfunction when euhydrated than when hypohydrated, and they had a mean decrease of 2 asymmetric landmarks on the standing structural examination when euhydrated but none when hypohydrated. Osteopathic manipulative treatment improved self-reported pain immediately after treatment regardless of hydration status. Outcome measures improved for all participants, with greater improvement observed after participants were treated in the euhydrated condition than when in the hypohydrated condition. It is reasonable for clinicians to

  12. Assessment of abuse liability of Tramadol among experienced drug users: Double-blind crossover randomized controlled trial.

    Science.gov (United States)

    Das, Mrinmay; Jain, Raka; Dhawan, Anju; Kaur, Amandeep

    Tramadol is a widely used opioid analgesic. Different preclinical, clinical, and postmarketing surveillance studies show conflicting results regarding abuse potential of this drug. A randomized double-blind complete crossover study was conducted at National Drug Dependence Treatment Centre, All India Institute of Medical Sciences, New Delhi. Total subjects were 10, comprising total 120 observations (each subject assessed at baseline, 5, 45, and 240 minutes). Subjects with history of substance abuse were included after detoxification and informed consent. Assessment was done using modified single dose opiate questionnaire, morphine benzedrine group (MBG), pentobarbital chlorpromazine alcohol group (PCAG), and two bipolar visual analogue scales (VAS) after administration of three drugs-Tramadol (100 mg), Buprenorphine (0.6 mg), and Placebo (Normal Saline) intramuscularly, at 5-day interval. In intra-group analysis, there was statistically significant increase in scores of all four scales from baseline to all three time points after Tramadol and Buprenorphine administration. In inter-group analysis, statistically higher scores were seen for Buprenorphine in comparison to Tramadol at 5, 45, and 240 minutes for MBG scale; the score was significantly higher for Buprenorphine in VAS for pleasurable effect at 45 and 240 minutes, but not at baseline and 5 minutes. There was no significant difference in score at any point of time between Tramadol and Buprenorphine in PCAG scale and VAS for sedative/alertness effect. The scores were statistically insignificant in case of Placebo. All the subjects liked Buprenorphine most and then Tramadol followed by Placebo. Tramadol has abuse potential (even in therapeutic doses) more than Placebo but less than or comparable to Buprenorphine.

  13. His or para-His pacing preserves left ventricular function in atrioventricular block: a double-blind, randomized, crossover study.

    Science.gov (United States)

    Kronborg, Mads B; Mortensen, Peter T; Poulsen, Steen H; Gerdes, Jens C; Jensen, Henrik K; Nielsen, Jens C

    2014-08-01

    To compare left ventricular function after a long-term His or para-His pacing (HP) and right ventricular septal pacing (RVSP) in patients with atrioventricular block (AVB). We included consecutive patients with AVB, a narrow QRS 0.40, in a prospective, randomized, double-blinded, crossover design. All patients were treated with 12 months HP and 12 months RVSP. A total of 38 patients [mean age, 67 ± 10 years; 30 (79%) men] were included. The primary endpoint was LVEF, which was significantly lower after a 12 months RVSP (0.50 ± 0.11) than after 12 months of HP (0.55 ± 0.10), P = 0.005. We measured the difference in time-to-peak systolic velocity between opposite basal segments in the apical views by using tissue Doppler imaging. In the four-chamber view, the difference was 58 (±7) ms after RVSP and 49 (±7) ms after HP, P = 0.27; in the two-chamber view, the difference was 45 (±5) ms after RVSP and 31 ±(4) ms after HP, P = 0.02, and in the apical long-axis view, the difference was 63 (±6) after RVSP and 44 (±7) after HP, P = 0.03. There was no difference in New York Heart Association class, 6-min hall walk test, quality-of-life assessments, or device-related complications. The mean threshold was significantly higher in HP leads than in RVSP leads. His or para-His pacing preserves LVEF and mechanical synchrony as compared with RVSP after 12 months pacing in patients with AVB, narrow QRS, and LVEF > 0.40. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

  14. Exercise- and Stress-Induced Hypoalgesia in Musicians with and without Shoulder Pain: A Randomized Controlled Crossover Study.

    Science.gov (United States)

    Kuppens, Kevin; Struyf, Filip; Nijs, Jo; Cras, Patrick; Fransen, Erik; Hermans, Linda; Meeus, Mira; Roussel, Nathalie

    2016-02-01

    Professional and pre-professional musicians are characterized by physical and psychological demands inherent to their musical activity, and therefore at risk for developing performance related musculoskeletal pain. Physical and psychological demands are known to influence human pain modulation. In this study we compared the influence of a physically and emotionally stressful task on pain thresholds in musicians with and without shoulder pain. A single-blinded randomized and controlled crossover study design was used to compare the effects of a physical versus emotional testing procedure on pressure pain thresholds (PPTs) in musicians with and without shoulder pain. All data were obtained in the field (e.g., at the physiotherapy accommodation in the Royal Conservatory). During the physical testing procedure, the subjects performed an isometric exercise of the glenohumeral external rotators. The emotional task comprised watching "unpleasant" images selected from the International Affective Picture System. The outcome was the assessment of change in PPTs before and after the physical and emotional task. Our results indicate similar effects of both protocols in either group, i.e., musicians with and without shoulder pain (P > 0.05). All musicians showed elevated PPTs at local and remote areas after isometric exercise (P effect size of Cohen's d = 1. Furthermore, comparing these results with those of non-musicians (both healthy subjects and patients with shoulder pain) might reveal information regarding the specific adaptations. Finally a high variability was observed in shoulder disability (i.e., SDQ-scores) as typically seen in a population with shoulder pain. In musicians with and without regional shoulder pain, no significant differences were found with respect to pain modulation during a physically and an emotionally stressful task. Both interventions adequately activated central and widespread pain inhibitory mechanisms in both groups.

  15. Use of videotape to assess mobility in a controlled randomized crossover trial of physiotherapy in chronic multiple sclerosis.

    Science.gov (United States)

    Wiles, C M; Newcombe, R G; Fuller, K J; Jones, A; Price, M

    2003-05-01

    To determine to what degree assessment of mobility based on comparison of videotape recordings before and after courses of physiotherapy in patients with chronic multiple sclerosis (MS) is reliable, correlates with 'live' assessments and indicates benefit. Prospective data collection within a randomized crossover controlled trial of physiotherapy at home, as an outpatient, or 'no therapy' in 40 patients. Hospital outpatients: outpatient and home physiotherapy. Mobility change based on a comparison of short video recordings before and after each treatment period was scored independently by two physiotherapists blinded to therapy type and other measures of outcome. Scores were compared with changes in the Rivermead Mobility Index (RMI) and other indices assessed by a physiotherapist in the patient's home. The two video observers agreed substantially on patient outcome. Changes in walking based on video correlated with RMI for home treatment (r = 0.41, p = 0.008) but not for hospital or no treatment periods (r = 0.14 and 0.15): video changes correlated with the 'live' assessor's global change score inconsistently ('no therapy' r = 0.48, p = 0.002, hospital r = 0.30, p = 0.06 and home r = 0.17, p = 0.30 treatment periods). Based on video data alone, improved mobility was evident following home therapy for only one observer but not for the other or the averaged scores of both. There was substantial agreement between two observers deciding on change in mobility based on independent blinded evaluation of short video sequences. However the correlations of these with 'live' assessments were variable. Physiotherapy had a less clear benefit on mobility based on video analysis alone compared with 'live' assessments. The study highlights the need for more objective measures of habitual mobility over longer periods.

  16. Caffeine intake, short bouts of physical activity, and energy expenditure: a double-blind randomized crossover trial.

    Directory of Open Access Journals (Sweden)

    Pedro B Júdice

    Full Text Available PA energy expenditure (PAEE is the most variable component of Total Energy Expenditure (TEE and largely due to the balance of sedentary time (SedT and low intensity physical activity (LIPA. There has been an emergence for seeking an understanding of factors which determine variations in SedT, LIPA, and PAEE. Sedentary behavior and physical activity are relatively resistant to change by experimental dietary treatments and significant body weight changes. Although caffeine (Caf is by far the most heavily used nutritional agent ingested to promote a sense of vigor/alertness, it is still unknown if Caf is effective in increasing PAEE and physical activity. The aim of the study was to test the hypothesis that 2 daily doses of Caf (as a capsule to blind the treatment and divided equally during breakfast and lunch increase PAEE and TEE, and it would do so through increasing the frequent and brief bouts of physical activity (~1-5 min long through the day as measured by accelerometry. In 21 low Caf users (<100 mg day(-1, we used a double-blind crossover trial (ClinicalTrials.govID;NCT01477294 with two conditions (4-day each with a 3-day washout period randomly ordered as 5 mg kg(-1 day(-1 of Caf and maltodextrin as placebo (Plc. Resting energy expenditure (REE by indirect calorimetry, total energy expenditure (TEE from doubly labeled water, PAEE calculated as TEE-(REE+0.1TEE, and accelerometry measurements of both LIPA and MVPA were not different between conditions. However, regardless of caffeine or placebo, there were several significant relationships between brief bouts of LIPA and MVPA with PAEE. In conclusion, this double-blind study found that low and moderate-vigorous activity as well as the total volume of PAEE in free-living conditions is resistant to dietary caffeine intake that was equivalent to 5 cups of espresso or 7 cups of tea.ClinicalTrials.gov NCT01477294.

  17. Flavanones protect from arterial stiffness in postmenopausal women consuming grapefruit juice for 6 mo: a randomized, controlled, crossover trial.

    Science.gov (United States)

    Habauzit, Véronique; Verny, Marie-Anne; Milenkovic, Dragan; Barber-Chamoux, Nicolas; Mazur, Andrzej; Dubray, Claude; Morand, Christine

    2015-07-01

    The consumption of citrus fruits is associated with health benefits. However, clinical data regarding the effects of grapefruit flavanone consumption on vascular function are lacking. The objective of the present study was to address the role of flavanones in the long-term effects induced by grapefruit juice (GFJ) consumption on vascular function in healthy postmenopausal women. Forty-eight healthy postmenopausal women aged 50-65 y within 3-10 y since menopause, a body mass index (in kg/m(2)) of 19-30, and a waist size >88 cm completed this double-blind, randomized, controlled, crossover trial. These volunteers were randomly assigned to consume 340 mL GFJ/d, providing 210 mg naringenin glycosides, or a matched control drink without flavanones for 6 mo each, with a 2-mo washout between beverages. The primary endpoint was the assessment of endothelial function in the brachial artery by using flow-mediated dilation. Blood pressure, arterial stiffness, and endothelial function in the peripheral arterial bed were also evaluated as indicators of vascular function. These measurements and blood collection for clinical biochemical markers were performed in overnight-fasted subjects before and after the 6-mo treatment periods. The mean ± SD carotid-femoral pulse wave velocity, which reflects central aortic stiffness, was statistically significantly lower after consumption of GFJ (7.36 ± 1.15 m/s) than after consumption of the matched control drink without flavanones (7.70 ± 1.36 m/s), with a P value of 0.019 for the treatment effect. Endothelial function in macro- and microcirculation, blood pressure, anthropometric measures, glucose metabolism, and biomarkers of inflammation and oxidative stress were not affected by the intervention. Regular GFJ consumption by middle-aged, healthy postmenopausal women is beneficial for arterial stiffness. This effect may be related to flavanones present in grapefruit. This trial was registered at clinicaltrials.gov as NCT01272167.

  18. 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.

  19. Live birth from a patient with a three-way balanced translocation t(5 ...

    African Journals Online (AJOL)

    Background: Three-way balanced translocations are unusual and can lead to infertility as well as abnormal embryos. In this case report, we describe a couple who experienced repeated miscarriages as a result of the male partner being a carrier of a three-way translocation t(5;8;12). Objectives: Array comparative genomic ...

  20. Randomized controlled trial of the combined monoaminergic and opioid investigational compound GRT9906 in painful polyneuropathy

    DEFF Research Database (Denmark)

    Sindrup, Søren Hein; Konder, R; Lehmann, R

    2012-01-01

    GRT9906 is an investigational novel compound with μ-opioid receptor agonism and inhibition of noradrenalin/serotonin re-uptake. In this randomized, double-blind, placebo-controlled, three-way cross-over trial in painful polyneuropathy, the efficacy and safety of GRT9906 was assessed and compared...

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

    Science.gov (United States)

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

    2016-01-01

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

  2. A 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 (pinsulin-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). 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

  3. Efficacy and safety of prolonged-release melatonin in insomnia patients with diabetes: a randomized, double-blind, crossover study

    Directory of Open Access Journals (Sweden)

    Garfinkel D

    2011-08-01

    Full Text Available Doron Garfinkel1, Mariana Zorin2, Julio Wainstein2, Zipora Matas3, Moshe Laudon4, Nava Zisapel4,51Geriatric Palliative Department, Shoham Geriatric Medical Center, Pardes Hana, Israel; 2Diabetes Unit, 3Biochemistry Laboratory, The E Wolfson Medical Center, Holon, Israel; 4Neurim Pharmaceuticals Ltd, 5Department of Neurobiology, Tel Aviv University, Tel Aviv, IsraelBackground: Diabetes is a major comorbidity in insomnia patients. The efficacy and safety of prolonged-release melatonin 2 mg in the treatment of glucose, lipid metabolism, and sleep was studied in 36 type 2 diabetic patients with insomnia (11 men, 25 women, age 46–77 years.Methods: In a randomized, double-blind, crossover study, the subjects were treated for 3 weeks (period 1 with prolonged-release melatonin or placebo, followed by a one-week washout period, and then crossed over for another 3 weeks (period 2 of treatment with the other preparation. All tablets were taken 2 hours before bedtime for a period of 3 weeks. In an extension period of 5 months, prolonged-release melatonin was given nightly to all patients in an open-label design. Sleep was objectively monitored in a subgroup of 22 patients using wrist actigraphy. Fasting glucose, fructosamine, insulin, C-peptide, triglycerides, total cholesterol, high-density and low-density lipoprotein cholesterol, and some antioxidants, as well as glycosylated hemoglobin (HbA1c levels were measured at baseline and at the end of the study. All concomitant medications were continued throughout the study.Results: No significant changes in serum glucose, fructosamine, insulin, C-peptide, antioxidant levels or blood chemistry were observed after 3 weeks of prolonged-release melatonin treatment. Sleep efficiency, wake time after sleep onset, and number of awakenings improved significantly with prolonged-release melatonin as compared with placebo. Following 5 months of prolonged-release melatonin treatment, mean HbA1c (±standard deviation was

  4. Portable Video Media Versus Standard Verbal Communication in Surgical Information Delivery to Nurses: A Prospective Multicenter, Randomized Controlled Crossover Trial.

    Science.gov (United States)

    Kam, Jonathan; Ainsworth, Hannah; Handmer, Marcus; Louie-Johnsun, Mark; Winter, Matthew

    2016-10-01

    Continuing education of health professionals is important for delivery of quality health care. Surgical nurses are often required to understand surgical procedures. Nurses need to be aware of the expected outcomes and recognize potential complications of such procedures during their daily work. Traditional educational methods, such as conferences and tutorials or informal education at the bedside, have many drawbacks for delivery of this information in a universal, standardized, and timely manner. The rapid uptake of portable media devices makes portable video media (PVM) a potential alternative to current educational methods. To compare PVM to standard verbal communication (SVC) for surgical information delivery and educational training for nurses and evaluate its impact on knowledge acquisition and participant satisfaction. Prospective, multicenter, randomized controlled crossover trial. Two hospitals: Gosford District Hospital and Wyong Hospital. Seventy-two nursing staff (36 at each site). Information delivery via PVM--7-minute video compared to information delivered via SVC. Knowledge acquisition was measured by a 32-point questionnaire, and satisfaction with the method of education delivery was measured using the validated Client Satisfaction Questionnaire (CSQ-8). Knowledge acquisition was higher via PVM compared to SVC 25.9 (95% confidence interval [CI] 25.2-26.6) versus 24.3 (95% CI 23.5-25.1), p = .004. Participant satisfaction was higher with PVM 29.5 (95% CI 28.3-30.7) versus 26.5 (95% CI 25.1-27.9), p = .003. Following information delivery via SVC, participants had a 6% increase in knowledge scores, 24.3 (95% CI 23.5-25.1) versus 25.7 (95% CI 24.9-26.5) p = .001, and a 13% increase in satisfaction scores, 26.5 (95% CI 25.1-27.9) versus 29.9 (95% CI 28.8-31.0) p < .001, when they crossed-over to information delivery via PVM. PVM provides a novel method for providing education to nurses that improves knowledge retention and satisfaction with the

  5. Efficacy of mandibular advancement device in the treatment of obstructive sleep apnea syndrome: A randomized controlled crossover clinical trial

    Science.gov (United States)

    Crovetto-Martínez, Rafael; Alkhraisat, Mohammad-Hamdan; Crovetto, Miguel; Municio, Antonio; Kutz, Ramón; Aizpuru, Felipe; Miranda, Erika; Anitua, Eduardo

    2015-01-01

    Background Evaluation of the efficacy and safety of a mandibular advancement device (MAD) (KlearwayTM) in the treatment of mild-to-moderate obstructive sleep apnea and chronic roncopathy. Material and Methods A randomized, placebo-controlled, double blinded, and crossover clinical trial was conducted. Placebo device (PD) defined as a splint in the centric occlusion that did not induce a mandibular advancement served as a control. The mandible was advanced to the maximum tolerable distance or to a minimum of 65% of the maximum protrusion. After each sequence of treatment, patients were assessed by questionnaires, conventional polysomnography, and objective measurement of snoring at the patient’s own home. Results Forty two patients participated in the study and 38 completed the study. Patients mean age was 46 ±9 years and the 79% were males. The mean mandibular advancement was 8.6 ±2.8 mm. Patients used the MAD and the PD for 6.4 +2.4 hours and 6.2 +2.0 hours, respectively. Secondary effects (mostly mild) occurred in the 85.7% and the 86.8% of the users of MAD and PD, respectively. The MAD induced a decrease in the apnea-hypopnea index (AHI) from 15.3 +10.2 to 11.9 +15.5. The 50% reduction in the AHI was achieved in the 46.2% and the 18.4% of the patients treated with MAD and PD, respectively. The use of the MAD induced a reduction in the AHI by 3.4 +15.9 while the PD induced an increase by 10.6 +26.1. The subjective evaluation of the roncopathy indicated an improvement by the MAD and an increase in the perceptive quality of sleep. However, the objective evaluation of the roncopathy did not show significant improvements. Conclusions The use of MAD is efficient to reduce the AHI and improve subjectively the roncopathy. MAD could be considered in the treatment of mild-to-moderate OSA and chronic roncopathy. Key words:Obstructive sleep apnea (OSA), mandibular advance device, treatment, efficacy, clinical assay. PMID:26241460

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

    Science.gov (United States)

    Fernemark, Hanna; Jaredsson, Christine; Bunjaku, Bekim; Rosenqvist, Ulf; Nystrom, Fredrik H; Guldbrand, Hans

    2013-01-01

    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 be

  7. Effects of Cytochrome P450 Inhibition and Induction on the Phenotyping Metrics of the Basel Cocktail: A Randomized Crossover Study.

    Science.gov (United States)

    Derungs, Adrian; Donzelli, Massimiliano; Berger, Benjamin; Noppen, Christoph; Krähenbühl, Stephan; Haschke, Manuel

    2016-01-01

    Activity of human cytochrome P450 enzymes (CYPs) shows high inter-and intra-individual variability, which is determined by genetic and non-genetic factors. Using a combination of CYP-specific probe drugs, phenotyping cocktails allow simultaneous assessment of the activity of different CYP isoforms. The objective of this study was to characterize the phenotyping metrics of the Basel cocktail in healthy male subjects with induced and inhibited CYP activity. In a randomized crossover study, the probe drugs for simultaneous phenotyping of CYP1A2 (caffeine), CYP2B6 (efavirenz), CYP2C9 (losartan), 2C19 (omeprazole), CYP2D6 (metoprolol), and CYP3A4 (midazolam) were administered to 16 subjects without pretreatment (baseline), after pretreatment with a combination of CYP inhibitors (ciprofloxacin, ketoconazole, and paroxetine), and after CYP induction with rifampicin. All subjects were genotyped. Pharmacokinetic profiles of the probe drugs and their main metabolites and metabolic ratios 2, 4, 6, and 8 h after probe drug application were determined in plasma and compared with the corresponding area under the plasma concentration-time curve (AUC) ratios. The Basel phenotyping cocktail was well tolerated by all subjects independent of pretreatment. Good correlations of metabolic ratios with AUC ratios of the corresponding probe drugs and their metabolites for all three conditions (baseline, CYP inhibition, and CYP induction) were found at 2 h after probe drug administration for CYP3A4, at 4 h for CYP1A2 and CYP2C19, and at 6 h for CYP2B6 and CYP2D6. While CYP inhibition significantly changed AUC ratios and metabolic ratios at these time points for all six CYP isoforms, CYP induction did not significantly change AUC ratios for CYP2C9. For CYP3A4, total 1'-hydroxymidazolam concentrations after pretreatment of samples with β-glucuronidase were needed to obtain adequate reflection of CYP induction by the metabolic ratio. Inhibition of CYP activity can be detected with the

  8. Effect of acute ozone induced airway inflammation on human sympathetic nerve traffic: a randomized, placebo controlled, crossover study.

    Directory of Open Access Journals (Sweden)

    Jens Tank

    Full Text Available BACKGROUND: Ozone concentrations in ambient air are related to cardiopulmonary perturbations in the aging population. Increased central sympathetic nerve activity induced by local airway inflammation may be one possible mechanism. METHODOLOGY/PRINCIPAL FINDINGS: To elucidate this issue further, we performed a randomized, double-blind, cross-over study, including 14 healthy subjects (3 females, age 22-47 years, who underwent a 3 h exposure with intermittent exercise to either ozone (250 ppb or clean air. Induced sputum was collected 3 h after exposure. Nineteen to 22 hours after exposure, we recorded ECG, finger blood pressure, brachial blood pressure, respiration, cardiac output, and muscle sympathetic nerve activity (MSNA at rest, during deep breathing, maximum-inspiratory breath hold, and a Valsalva maneuver. While the ozone exposure induced the expected airway inflammation, as indicated by a significant increase in sputum neutrophils, we did not detect a significant estimated treatment effect adjusted for period on cardiovascular measurements. Resting heart rate (clean air: 59±2, ozone 60±2 bpm, blood pressure (clean air: 121±3/71±2 mmHg; ozone: 121±2/71±2 mmHg, cardiac output (clean air: 7.42±0.29 mmHg; ozone: 7.98±0.60 l/min, and plasma norepinephrine levels (clean air: 213±21 pg/ml; ozone: 202±16 pg/ml, were similar on both study days. No difference of resting MSNA was observed between ozone and air exposure (air: 23±2, ozone: 23±2 bursts/min. Maximum MSNA obtained at the end of apnea (air: 44±4, ozone: 48±4 bursts/min and during the phase II of the Valsalva maneuver (air: 64±5, ozone: 57±6 bursts/min was similar. CONCLUSIONS/SIGNIFICANCE: Our study suggests that acute ozone-induced airway inflammation does not increase resting sympathetic nerve traffic in healthy subjects, an observation that is relevant for environmental health. However, we can not exclude that chronic airway inflammation may contribute to sympathetic

  9. 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.

  10. 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

  11. No difference between alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients: a randomized crossover trial

    DEFF Research Database (Denmark)

    Hansen, Ditte; Rasmussen, Knud; Danielsen, Henning

    2011-01-01

    clinical trial, we originally intended two crossover study periods with a washout interval in 86 chronic hemodialysis patients. These patients received increasing intravenous doses of either alfacalcidol or paricalcitol for 16 weeks, until parathyroid hormone was adequately suppressed or calcium...... were equally effective in the suppression of secondary hyperparathyroidism in hemodialysis patients while calcium and phosphorus were kept in the desired range...

  12. Efficient assessment of efficacy in post-traumatic peripheral neuropathic pain patients: pregabalin in a randomized, placebo-controlled, crossover study

    Directory of Open Access Journals (Sweden)

    Jenkins TM

    2012-07-01

    Full Text Available Tim M Jenkins, Trevor S Smart, Frances Hackman, Carol Cooke, Keith KC TanClinical Research, Pfizer Worldwide Research and Development, Sandwich, Kent, UKBackground: Detecting the efficacy of novel analgesic agents in neuropathic pain is challenging. There is a critical need for study designs with the desirable characteristics of assay sensitivity, low placebo response, reliable pain recordings, low cost, short duration of exposure to test drug and placebo, and relevant and recruitable population.Methods: We designed a proof-of-concept, double-blind, randomized, placebo-controlled, crossover study in patients with post-traumatic peripheral neuropathic pain (PTNP to evaluate whether such a study design had the potential to detect efficacious agents. Pregabalin, known to be efficacious in neuropathic pain, was used as the active analgesic. We also assessed physical activity throughout the study.Results: Twenty-five adults (20–70 years of age with PTNP for ≥3 months entered a screening week and were then randomized to one of the two following treatment sequences: (1 pregabalin followed by placebo or (2 placebo followed by pregabalin. These 2-week treatment periods were separated by a 2-week washout period. Patients on pregabalin treatment received escalating doses to a final dosage of 300 mg/day (days 5–15. In an attempt to minimize placebo response, patients received placebo treatment during the screening week and the 2-week washout period. Average daily pain scores (primary endpoint were significantly reduced for pregabalin versus placebo, with a mean treatment difference of -0.81 (95% confidence interval: -1.45 to -0.17; P = 0.015.Conclusion: The efficacy of pregabalin was similar to that identified in a large, parallel group trial in PTNP. Therefore, this efficient crossover study design has potential utility for future proof-of-concept studies in neuropathic pain.Keywords: pregabalin, post-traumatic peripheral neuropathic pain, randomized

  13. Moderate replacement of carbohydrates by dietary fats affects features of metabolic syndrome: a randomized crossover clinical trial.

    Science.gov (United States)

    Rajaie, Somayeh; Azadbakht, Leila; Khazaei, Majid; Sherbafchi, Mostafa; Esmaillzadeh, Ahmad

    2014-01-01

    Earlier studies on the management of metabolic syndrome (MetS) have mostly focused on very low carbohydrate diets, whereas long-term adherence to such diets is difficult for apparently healthy people. The aim of this study was to examine the effects of moderate replacement of carbohydrates by dietary fats on insulin resistance and features of MetS among women. This randomized crossover clinical trial was performed with 30 overweight or obese (body mass index [BMI] > 25 kg/m(2)) women with MetS. After a 2-wk run-in period, participants were randomly assigned to consume either a calorie-restricted high-carbohydrate (HC) diet (60%-65% of energy from carbohydrates and 20%-25% from fats) or a calorie-restricted moderately restricted carbohydrate (MRC) diet (43%-47% of total calories as carbohydrate and 36%-40% as dietary fats) for 6 wk. Protein contents of both diets were 15% to 17% of total energy. A 2-wk washout period was applied following which participants were crossed over to the alternate treatment arm for an additional 6 wk. Anthropometric, blood pressure, and biochemical measurements were performed before and after each phase of intervention. Mean age and BMI of study participants was 42.4 y and 33 kg/m(2), respectively. A trend toward greater reduction in waist (-3.9 versus -2.6 cm; P = 0.07) and hip circumferences (-2.7 versus -1.5 cm; P = 0.07) as well as serum triglyceride (TG) levels (-31.3 versus 0.13 mg/dL; P = 0.07) was observed after consumption of an MRC diet compared with an HC diet. The TG to high-density lipoprotein cholesterol (HDL-C) ratio had a tendency to improve with the MRC diet rather than the HC diet (-0.9 versus -0.1; P = 0.06). Consumption of the MRC diet resulted in a greater reduction of systolic blood pressure (-8.93 versus -2.97 mm Hg; P = 0.06) and diastolic blood pressure (-12.7 versus -1.77 mm Hg; P = 0.001) compared with the HC diet. The prevalence of MetS was significantly decreased following the consumption of the MRC diet (P

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

    Science.gov (United States)

    Kim, Myoung Kwon; Shin, Young Jun

    2017-11-21

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

  15. Performance of three-way data types during Voyager's encounter with Neptune

    Science.gov (United States)

    Roth, D. C.; Taylor, T. H.; Jacobson, R. A.; Lewis, G. D.

    1990-01-01

    Voyager's flyby of Neptune in August of 1989 was the most distant planetary encounter ever achieved. Round trip light travel time was more than eight hours, exceeding view periods at two of the three tracking station sites. Consequently, the majority of radiometric tracking was accomplished by transmitting the uplink from one station, and receiving the downlink at a different station. This procedure defines three-way data. Dependence on three-way data for orbit determination is one distinguishing element of Voyager's successful encounter with Neptune. This paper addresses the performance of three-way range and Doppler data supporting pre-encounter orbit determination and post-encounter orbit reconstruction. Also, calibrations which reduce systematic errors inherent to three-way data are described and analyzed.

  16. Genome-Wide Prediction of the Performance of Three-Way Hybrids in Barley

    Directory of Open Access Journals (Sweden)

    Zuo Li

    2017-03-01

    Full Text Available Predicting the grain yield performance of three-way hybrids is challenging. Three-way crosses are relevant for hybrid breeding in barley ( L. and maize ( L. adapted to East Africa. The main goal of our study was to implement and evaluate genome-wide prediction approaches of the performance of three-way hybrids using data of single-cross hybrids for a scenario in which parental lines of the three-way hybrids originate from three genetically distinct subpopulations. We extended the ridge regression best linear unbiased prediction (RRBLUP and devised a genomic selection model allowing for subpopulation-specific marker effects (GSA-RRBLUP: general and subpopulation-specific additive RRBLUP. Using an empirical barley data set, we showed that applying GSA-RRBLUP tripled the prediction ability of three-way hybrids from 0.095 to 0.308 compared with RRBLUP, modeling one additive effect for all three subpopulations. The experimental findings were further substantiated with computer simulations. Our results emphasize the potential of GSA-RRBLUP to improve genome-wide hybrid prediction of three-way hybrids for scenarios of genetically diverse parental populations. Because of the advantages of the GSA-RRBLUP model in dealing with hybrids from different parental populations, it may also be a promising approach to boost the prediction ability for hybrid breeding programs based on genetically diverse heterotic groups.

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

    Science.gov (United States)

    Assawawitoontip, Surin; Wiwanitkit, Viroj

    2002-06-01

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

  18. 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 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 higher with BICA compared to the

  19. 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

  20. The effects of a prophylactic knee brace and two neoprene knee sleeves on the performance of healthy athletes: a crossover randomized controlled trial.

    Science.gov (United States)

    Mortaza, Niyousha; Ebrahimi, Ismail; Jamshidi, Ali Ashraf; Abdollah, Vahid; Kamali, Mohammad; Abas, Wan Abu Bakar Wan; Osman, Noor Azuan Abu

    2012-01-01

    Knee injury is one of the major problems in sports medicine, and the use of prophylactic knee braces is an attempt to reduce the occurrence and/or severity of injuries to the knee joint ligament(s) without inhibiting knee mobility. The aim of the present study was to examine the effect of one recently designed prophylactic knee brace and two neoprene knee sleeves upon performance of healthy athletes. Thirty-one healthy male athletes (age = 21.2 ± 1.5) volunteered as participants to examine the effect of prophylactic knee brace/sleeves on performance using isokinetic and functional tests. All subjects were tested in four conditions in a random order: 1. nonbraced (control) 2. using a neoprene knee sleeve 3. using a knee sleeve with four bilateral metal supports and 4. using a prophylactic knee brace. The study design was a crossover, randomized, controlled trial. Subjects completed single leg vertical jump, cross-over hop, and the isokinetic knee flexion and extension (at 60, 180, 300°/sec). Data were collected from the above tests and analyzed for jump height, cross-over hop distance, peak torque to body weight ratio and average power, respectively. Comparisons of these variables in the four testing conditions revealed no statistically significant difference (p>0.05). The selected prophylactic brace/sleeves did not significantly inhibit athletic performance which might verify that their structure and design have caused no complication in the normal function of the knee joint. Moreover, it could be speculated that, if the brace or the sleeves had any limiting effect, our young healthy athletic subjects were well able to generate a mean peak torque large enough to overcome this possible restriction. Further studies are suggested to investigate the long term effect of these prophylactic knee brace and sleeves as well as their possible effect on the adjacent joints to the knee.

  1. The effects of a prophylactic knee brace and two neoprene knee sleeves on the performance of healthy athletes: a crossover randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Niyousha Mortaza

    Full Text Available Knee injury is one of the major problems in sports medicine, and the use of prophylactic knee braces is an attempt to reduce the occurrence and/or severity of injuries to the knee joint ligament(s without inhibiting knee mobility. The aim of the present study was to examine the effect of one recently designed prophylactic knee brace and two neoprene knee sleeves upon performance of healthy athletes. Thirty-one healthy male athletes (age = 21.2 ± 1.5 volunteered as participants to examine the effect of prophylactic knee brace/sleeves on performance using isokinetic and functional tests. All subjects were tested in four conditions in a random order: 1. nonbraced (control 2. using a neoprene knee sleeve 3. using a knee sleeve with four bilateral metal supports and 4. using a prophylactic knee brace. The study design was a crossover, randomized, controlled trial. Subjects completed single leg vertical jump, cross-over hop, and the isokinetic knee flexion and extension (at 60, 180, 300°/sec. Data were collected from the above tests and analyzed for jump height, cross-over hop distance, peak torque to body weight ratio and average power, respectively. Comparisons of these variables in the four testing conditions revealed no statistically significant difference (p>0.05. The selected prophylactic brace/sleeves did not significantly inhibit athletic performance which might verify that their structure and design have caused no complication in the normal function of the knee joint. Moreover, it could be speculated that, if the brace or the sleeves had any limiting effect, our young healthy athletic subjects were well able to generate a mean peak torque large enough to overcome this possible restriction. Further studies are suggested to investigate the long term effect of these prophylactic knee brace and sleeves as well as their possible effect on the adjacent joints to the knee.

  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. Fentanyl Buccal Tablet vs. Oral Morphine in Doses Proportional to the Basal Opioid Regimen for the Management of Breakthrough Cancer Pain: A Randomized, Crossover, Comparison Study.

    Science.gov (United States)

    Mercadante, Sebastiano; Adile, Claudio; Cuomo, Arturo; Aielli, Federica; Cortegiani, Andrea; Casuccio, Alessandra; Porzio, Giampiero

    2015-11-01

    Fentanyl products have shown superiority to oral opioids for the management of breakthrough cancer pain (BTcP). However, these studies did not use appropriate patient selection, and drugs have been compared by using different rationales. The aim of this randomized, crossover, controlled study was to compare efficacy and safety of fentanyl buccal tablets (FBTs) and oral morphine (OM), given in doses proportional to opioid daily doses. Cancer patients with pain receiving ≥60 mg or more of oral morphine equivalents per day and presenting with ≤3 episodes of BTcP per day were included. In a randomized, crossover manner, patients received FBT or OM at doses proportional to the daily opioid regimen in four consecutive episodes of BTcP. Pain intensity was measured before (T0) and 15 (T15) and 30 minutes (T30), after study drugs. In total, 263 episodes of BTcP were treated. A statistical difference in changes in pain intensity-decrease of ≥33% and ≥50%-between the two groups was observed at T15 and T30 (P medication. Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2017-05-01

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

  5. 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......-in period of two weeks, two treatment periods of five weeks separated by a three weeks' washout period. The primary efficacy variable was the change in the mean pain intensity score from baseline to the last week of treatment. Other variables included pain relief, health related quality of life (SF-36......), interference of sleep by pain, Clinician and Patient Global Impression of Change, and adverse effects. Nine centers randomized a total of 120 patients, 22 of whom withdrew. There was no statistically significant difference between the treatments for the primary outcome efficacy variable. However, gabapentin...

  6. Effect of whole milk compared with skimmed milk on fasting blood lipids in healthy adults: a 3-week randomized crossover study

    DEFF Research Database (Denmark)

    Engel, Sara; Elhauge, Mie; Tholstrup, Tine

    2017-01-01

    overall dairy intake and risk of cardiovascular disease and even point to an inverse association with type 2 diabetes. The objective was to compare the effects of whole milk (3.5% fat) with skimmed milk (0.1% fat) on fasting serum blood lipids, insulin, and plasma glucose in healthy subjects. Subject....../methods A randomized, controlled 2 × 3-week crossover dietary intervention in 18 healthy adults randomly assigned to a sequence of treatments consisting of 0.5 L/d of whole milk and skimmed milk as part of their habitual diet. A total of 17 subjects completed the intervention. Results Whole milk increased HDL...... cholesterol concentrations significantly compared to skimmed milk (P milk and skimmed milk in effects on total and LDL cholesterol, triacylglycerol, insulin, and glucose concentrations. Conclusions Intake of 0.5 L/d of whole milk did not adversely...

  7. 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...

  8. Bioequivalence between innovator and generic tacrolimus in liver and kidney transplant recipients: A randomized, crossover clinical trial.

    Directory of Open Access Journals (Sweden)

    Rita R Alloway

    2017-11-01

    Full Text Available Although the generic drug approval process has a long-term successful track record, concerns remain for approval of narrow therapeutic index generic immunosuppressants, such as tacrolimus, in transplant recipients. Several professional transplant societies and publications have generated skepticism of the generic approval process. Three major areas of concern are that the pharmacokinetic properties of generic products and the innovator (that is, "brand" product in healthy volunteers may not reflect those in transplant recipients, bioequivalence between generic and innovator may not ensure bioequivalence between generics, and high-risk patients may have specific bioequivalence concerns. Such concerns have been fueled by anecdotal observations and retrospective and uncontrolled published studies, while well-designed, controlled prospective studies testing the validity of the regulatory bioequivalence testing approach for narrow therapeutic index immunosuppressants in transplant recipients have been lacking. Thus, the present study prospectively assesses bioequivalence between innovator tacrolimus and 2 generics in individuals with a kidney or liver transplant.From December 2013 through October 2014, a prospective, replicate dosing, partially blinded, randomized, 3-treatment, 6-period crossover bioequivalence study was conducted at the University of Cincinnati in individuals with a kidney (n = 35 or liver transplant (n = 36. Abbreviated New Drug Applications (ANDA data that included manufacturing and healthy individual pharmacokinetic data for all generics were evaluated to select the 2 most disparate generics from innovator, and these were named Generic Hi and Generic Lo. During the 8-week study period, pharmacokinetic studies assessed the bioequivalence of Generic Hi and Generic Lo with the Innovator tacrolimus and with each other. Bioequivalence of the major tacrolimus metabolite was also assessed. All products fell within the US Food and Drug

  9. Bioequivalence between innovator and generic tacrolimus in liver and kidney transplant recipients: A randomized, crossover clinical trial.

    Science.gov (United States)

    Alloway, Rita R; Vinks, Alexander A; Fukuda, Tsuyoshi; Mizuno, Tomoyuki; King, Eileen C; Zou, Yuanshu; Jiang, Wenlei; Woodle, E Steve; Tremblay, Simon; Klawitter, Jelena; Klawitter, Jost; Christians, Uwe

    2017-11-01

    Although the generic drug approval process has a long-term successful track record, concerns remain for approval of narrow therapeutic index generic immunosuppressants, such as tacrolimus, in transplant recipients. Several professional transplant societies and publications have generated skepticism of the generic approval process. Three major areas of concern are that the pharmacokinetic properties of generic products and the innovator (that is, "brand") product in healthy volunteers may not reflect those in transplant recipients, bioequivalence between generic and innovator may not ensure bioequivalence between generics, and high-risk patients may have specific bioequivalence concerns. Such concerns have been fueled by anecdotal observations and retrospective and uncontrolled published studies, while well-designed, controlled prospective studies testing the validity of the regulatory bioequivalence testing approach for narrow therapeutic index immunosuppressants in transplant recipients have been lacking. Thus, the present study prospectively assesses bioequivalence between innovator tacrolimus and 2 generics in individuals with a kidney or liver transplant. From December 2013 through October 2014, a prospective, replicate dosing, partially blinded, randomized, 3-treatment, 6-period crossover bioequivalence study was conducted at the University of Cincinnati in individuals with a kidney (n = 35) or liver transplant (n = 36). Abbreviated New Drug Applications (ANDA) data that included manufacturing and healthy individual pharmacokinetic data for all generics were evaluated to select the 2 most disparate generics from innovator, and these were named Generic Hi and Generic Lo. During the 8-week study period, pharmacokinetic studies assessed the bioequivalence of Generic Hi and Generic Lo with the Innovator tacrolimus and with each other. Bioequivalence of the major tacrolimus metabolite was also assessed. All products fell within the US Food and Drug Administration

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

    Science.gov (United States)

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

    2015-04-01

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

  11. Integrating Reading, Information Literacy, and Literary Studies Instruction in a Three-Way Collaboration

    Science.gov (United States)

    Mazella, David; Heidel, Laura; Ke, Irene

    2011-01-01

    This article describes a unique course-based collaboration involving an English professor, a Learning Strategies Counselor, and a Librarian. The potential benefits and barriers of collaborative teaching in literature are reviewed. The article delineates a three-way instruction model built around an annotated bibliography assignment in a…

  12. Development of a model-based controller for a three-way catalytic converter

    NARCIS (Netherlands)

    Bie, T. de; Balenovic, M.; Backx, T.

    2002-01-01

    The performance of a three-way catalytic converter under transient operation can be improved by controlling the level of oxygen stored on ceria at some optimal level. A model-based controller with the model estimating the level of ceria coverage by oxygen, can achieve this goal. A simple, dynamic

  13. Pilates exercises improve low back pain and quality of life in patients with HTLV-1 virus: a randomized crossover clinical trial.

    Science.gov (United States)

    Borges, Jaqueline; Baptista, Abrahão Fontes; Santana, Nayara; Souza, Israel; Kruschewsky, Ramon A; Galvão-Castro, Bernardo; Sá, Katia Nunes

    2014-01-01

    Low back pain is highly prevalent in patients with HTLV-1. The effects of physical activity on this condition are not known, but postural misalignment and motor deficits are frequently present. To assess the effect of Pilates exercises on chronic low back pain in these patients, and its impact on quality of life. A randomized crossover clinical trial was conducted, involving 22 patients from a reference center in Salvador, Bahia, Brazil. The VAS was used to evaluate the effect of Pilates on pain intensity and the SF-36 to assess its impact on quality of life. Our results provide evidence of positive effects on pain intensity and almost all domains of quality of life when patients followed the Pilates exercise program described. The Pilates method may be a useful tool in alleviating the symptoms of low back pain, and had a significant impact on quality of life in this sample of patients. Copyright © 2013 Elsevier Ltd. All rights reserved.

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

    DEFF Research Database (Denmark)

    Jensen, Lars Henrik; Osterlind, Kell; Rytter, Carsten

    2008-01-01

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

  15. Randomized prospective crossover study of biphasic intermittent positive airway pressure ventilation (BIPAP) versus pressure support ventilation (PSV) in surgical intensive care patients.

    Science.gov (United States)

    Elrazek, E Abd

    2004-10-01

    The aim of this prospective, randomized and crossover study was to assess the role of a relatively new mode of mechanical ventilation, biphasic intermittent positive airway pressure (BIPAP) in comparison to another well established one, pressure-support ventilation (PSV) in surgical intensive care patients. 24 generally stable patients, breathing on their own after short-term (PSV or BIPAP, and indirect calorimetry measurements were performed after 1 hour adaptation period at two time intervals; immediately after the investigated ventilatory mode was started and 1 hour later. Statistics included a two-tailed paired t-test to compare the two sets of different data, p PSV and BIPAP can be used for weaning patients comfortably in surgical intensive care after short-term postoperative ventilation. BIPAP may have the credit of being smoother than PSV where no patient effort is required.

  16. A comparative evaluation of intranasal midazolam, ketamine and their combination for sedation of young uncooperative pediatric dental patients: a triple blind randomized crossover trial.

    Science.gov (United States)

    Bahetwar, S K; Pandey, R K; Saksena, A K; Chandra, Girish

    2011-01-01

    The purpose of this study was to evaluate and compare the efficacy and safety of intranasal (IN) administration of midazolam (M), ketamine (K) and their combination (MK) to produce moderate sedation in young, uncooperative pediatric dental patients. In this three stage crossover trial forty five uncooperative ASA type-1 children, who required dental treatment, were randomly assigned to receive one of the three drugs/combination by IN route during three subsequent visits. The efficacy and safety of the agents were assessed by overall success rate and by monitoring of vital signs, respectively. The onset of sedation was rapid with K as compared to M and MK. The difference was statistically significant (P pediatric dental patients who have been otherwise indicated for treatment under general anesthesia.

  17. Hypnosis and Local Anesthesia for Dental Pain Relief-Alternative or Adjunct Therapy?-A Randomized, Clinical-Experimental Crossover Study.

    Science.gov (United States)

    Wolf, Thomas Gerhard; Wolf, Dominik; Callaway, Angelika; Below, Dagna; d'Hoedt, Bernd; Willershausen, Brita; Daubländer, Monika

    2016-01-01

    This prospective randomized clinical crossover trial was designed to compare hypnosis and local anesthesia for experimental dental pain relief. Pain thresholds of the dental pulp were determined. A targeted standardized pain stimulus was applied and rated on the Visual Analogue Scale (0-10). The pain threshold was lower under hypnosis (58.3 ± 17.3, p local anesthesia. The pain stimulus was scored higher under hypnosis (3.9 ± 3.8) than with local anesthesia (0.0, p Local anesthesia was superior to hypnosis and is a safe and effective method for pain relief in dentistry. Hypnosis seems to produce similar effects observed under sedation. It can be used in addition to local anesthesia and in individual cases as an alternative for pain control in dentistry.

  18. Two randomized cross-over trials assessing the impact of dietary gluten or wholegrain on the gut microbiome and host metabolic health

    DEFF Research Database (Denmark)

    Ibrügger, Sabine; Gøbel, Rikke Juul; Vestergaard, Henrik

    2014-01-01

    Background: Gut microbiota composition and activity may be changed by dietary factors and possibly affect metabolic health. Dietary gluten and wholegrain are suggested to influence metabolism in a negative and positive direction, respectively. Objective: Describe the design and rational as well...... as baseline characteristics of two human intervention studies, within the Gut, Grain and Greens (3G) Center, investigating the effects of a gluten-poor and wholegrain-rich diet on microbiota composition and metabolic health. Design: The gluten and wholegrain studies had a randomized, controlled, cross......-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...

  19. Is prevention of acute pesticide poisoning effective and efficient, with Locally Adapted Personal Protective Equipment? A randomized crossover study among farmers in Chitwan, Nepal

    DEFF Research Database (Denmark)

    Varma, Anshu; Neupane, Dinesh; Bonde, Jens Peter Ellekilde

    2016-01-01

    . Based on the farmers' working behavior, compounds used, intensity and exposure duration we conclude that Locally Adapted Personal Protective Equipment does not provide additional protection during usual work practices. However, our Locally Adapted Personal Protective Equipment might offer protection...... exposure among farmers. Methods: In a crossover study, 45 male farmers from Chitwan, Nepal, were randomly allocated to work as usual applying organophosphate pesticides wearing Locally Adapted Personal Protective Equipment or Daily Practice Clothing. For seven days before each experiment, each farmer...... the expectation that our farmers in Chitwan, Nepal working with Locally Adapted Personal Protective Equipment would have fewer acute organophosphate poisoning symptoms, higher plasma cholinesterase (U/mL) and find it more efficient to work with the equipment than farmers working with their Daily Practice Clothing...

  20. The Effects of Aroma Foot Massage on Blood Pressure and Anxiety in Japanese Community-Dwelling Men and Women: A Crossover Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Eri Eguchi

    Full Text Available The aim of this study was to investigate the effects of aroma foot massage on blood pressure, anxiety, and health-related quality of life (QOL in Japanese community-dwelling men and women using a crossover randomized controlled trial.Fifty-seven eligible participants (5 men and 52 women aged 27 to 72 were randomly divided into 2 intervention groups (group A: n = 29; group B: n = 28 to participate in aroma foot massages 12 times during the 4-week intervention period. Systolic and diastolic blood pressure (SBP and DBP, respectively, heart rate, state anxiety, and health-related QOL were measured at the baseline, 4-week follow-up, and 8-week follow-up. The effects of the aroma foot massage intervention on these factors and the proportion of participants with anxiety were analyzed using a linear mixed-effect model for a crossover design adjusted for participant and period effects. Furthermore, the relationship between the changes in SBP and state anxiety among participants with relieved anxiety was assessed using a linear regression model.Aroma foot massage significantly decreased the mean SBP (p = 0.02, DBP (p = 0.006, and state anxiety (p = 0.003 as well as the proportion of participants with anxiety (p = 0.003. Although it was not statistically significant (p = 0.088, aroma foot massage also increased the score of mental health-related QOL. The change in SBP had a significant and positive correlation with the change in state anxiety (p = 0.01 among participants with relieved anxiety.The self-administered aroma foot massage intervention significantly decreased the mean SBP and DBP as well as the state anxiety score, and tended to increase the mental health-related QOL scores. The results suggest that aroma foot massage may be an easy and effective way to improve mental health and blood pressure.University Hospital Medical Information Network 000014260.

  1. Promising effects of oxytocin on social and food-related behaviour in young children with Prader-Willi syndrome: a randomized, double-blind, controlled crossover trial.

    Science.gov (United States)

    Kuppens, R J; Donze, S H; Hokken-Koelega, A C S

    2016-12-01

    Prader-Willi syndrome (PWS) is known for hyperphagia with impaired satiety and a specific behavioural phenotype with stubbornness, temper tantrums, manipulative and controlling behaviour and obsessive-compulsive features. PWS is associated with hypothalamic and oxytocinergic dysfunction. In humans without PWS, intranasal oxytocin administration had positive effects on social and eating behaviour, and weight balance. To evaluate the effects of intranasal oxytocin compared to placebo administration on social behaviour and hyperphagia in children with PWS. Randomized, double-blind, placebo-controlled, crossover study in a PWS Reference Center in the Netherlands. Crossover intervention with twice daily intranasal oxytocin (dose range 24-48 IU/day) and placebo administration, both during 4 weeks, in 25 children with PWS (aged 6 to 14 years). In the total group, no significant effects of oxytocin on social behaviour or hyperphagia were found, but in the 17 children younger than 11 years, parents reported significantly less anger (P = 0·001), sadness (P = 0·005), conflicts (P = 0·010) and food-related behaviour (P = 0·011), and improvement of social behaviour (P = 0·018) during oxytocin treatment compared with placebo. In the eight children older than 11 years, the items happiness (P = 0·039), anger (P = 0·042) and sadness (P = 0·042) were negatively influenced by oxytocin treatment compared to placebo. There were no side effects or adverse events. This randomized, double-blind, placebo-controlled study suggests that intranasal oxytocin administration has beneficial effects on social behaviour and food-related behaviour in children with PWS younger than 11 years of age, but not in those older than 11 years of age. © 2016 The Authors. Clinical Endocrinology published by John Wiley & Sons Ltd.

  2. The Effects of Aroma Foot Massage on Blood Pressure and Anxiety in Japanese Community-Dwelling Men and Women: A Crossover Randomized Controlled Trial.

    Science.gov (United States)

    Eguchi, Eri; Funakubo, Narumi; Tomooka, Kiyohide; Ohira, Tetsuya; Ogino, Keiki; Tanigawa, Takeshi

    2016-01-01

    The aim of this study was to investigate the effects of aroma foot massage on blood pressure, anxiety, and health-related quality of life (QOL) in Japanese community-dwelling men and women using a crossover randomized controlled trial. Fifty-seven eligible participants (5 men and 52 women) aged 27 to 72 were randomly divided into 2 intervention groups (group A: n = 29; group B: n = 28) to participate in aroma foot massages 12 times during the 4-week intervention period. Systolic and diastolic blood pressure (SBP and DBP, respectively), heart rate, state anxiety, and health-related QOL were measured at the baseline, 4-week follow-up, and 8-week follow-up. The effects of the aroma foot massage intervention on these factors and the proportion of participants with anxiety were analyzed using a linear mixed-effect model for a crossover design adjusted for participant and period effects. Furthermore, the relationship between the changes in SBP and state anxiety among participants with relieved anxiety was assessed using a linear regression model. Aroma foot massage significantly decreased the mean SBP (p = 0.02), DBP (p = 0.006), and state anxiety (p = 0.003) as well as the proportion of participants with anxiety (p = 0.003). Although it was not statistically significant (p = 0.088), aroma foot massage also increased the score of mental health-related QOL. The change in SBP had a significant and positive correlation with the change in state anxiety (p = 0.01) among participants with relieved anxiety. The self-administered aroma foot massage intervention significantly decreased the mean SBP and DBP as well as the state anxiety score, and tended to increase the mental health-related QOL scores. The results suggest that aroma foot massage may be an easy and effective way to improve mental health and blood pressure. University Hospital Medical Information Network 000014260.

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

    Science.gov (United States)

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

    2015-10-01

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

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

    Science.gov (United States)

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

    2015-09-01

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

  5. Electroacupuncture prevents endothelial dysfunction induced by ischemia-reperfusion injury via a cyclooxygenase-2-dependent mechanism: A randomized controlled crossover trial.

    Directory of Open Access Journals (Sweden)

    Seung Min Kathy Lee

    Full Text Available Exploring clinically effective methods to reduce ischemia-reperfusion (IR injury in humans is critical. Several drugs have shown protective effects, but studies using other interventions have been rare. Electroacupuncture (EA has induced similar protection in several animal studies but no study has investigated how the effects could be translated and reproduced in humans. This study aimed to explore the potential effect and mechanisms of EA in IR-induced endothelial dysfunction in humans.This is a prospective, randomized, crossover, sham-controlled trial consisting of two protocols. Protocol 1 was a crossover study to investigate the effect of EA on IR-induced endothelial dysfunction. Twenty healthy volunteers were randomly assigned to EA or sham EA (sham. Flow mediated dilation (FMD of the brachial artery (BA, nitroglycerin-mediated endothelial independent dilation, blood pressure before and after IR were measured. In protocol 2, seven volunteers were administered COX-2 inhibitor celecoxib (200 mg orally twice daily for five days. After consumption, volunteers underwent FMD before and after IR identical to protocol 1.In protocol 1, baseline BA diameter, Pre-IR BA diameter and FMD were similar between the two groups (p = NS. After IR, sham group showed significantly blunted FMD (Pre-IR: 11.41 ± 3.10%, Post-IR: 4.49 ± 2.04%, p < 0.001. However, EA protected this blunted FMD (Pre-IR: 10.96 ± 5.30%, Post-IR: 9.47 ± 5.23%, p = NS, p < 0.05 compared with sham EA after IR. In protocol 2, this protective effect was completely abolished by pre-treatment with celecoxib (Pre-IR: 11.05 ± 3.27%; Post-IR: 4.20 ± 1.68%, p = 0.001.EA may prevent IR-induced endothelial dysfunction via a COX-2 dependent mechanism.

  6. Efficacy and safety of 10-mg azilsartan compared with 8-mg candesartan cilexetil in Japanese patients with hypertension: a randomized crossover non-inferiority trial.

    Science.gov (United States)

    Takahara, Mitsuyoshi; Shiraiwa, Toshihiko; Shindo, Megumi; Arai, Akie; Kusuda, Yuko; Katakami, Naoto; Kaneto, Hideaki; Matsuoka, Taka-Aki; Shimomura, Iichiro

    2014-09-01

    We investigated whether 10 mg per day of azilsartan, one-half of the normal dosage, would be non-inferior to 8 mg per day of candesartan cilexetil for controlling blood pressure in Japanese patients with hypertension. In this open-label, randomized, crossover trial, 309 hypertensive Japanese adults treated with 8-mg candesartan cilexetil were randomized into two arms and received either 10-mg azilsartan or 8-mg candesartan cilexetil in a crossover manner. The primary efficacy outcome was systolic blood pressure, and the margin of non-inferiority was set to be 2.5 mm Hg. The participants were 67±11 years old, and 180 (58%) were male. The baseline systolic and diastolic blood pressure levels were 127.1±13.2 and 69.7±11.2 mm Hg, respectively. During the study period, the difference in systolic blood pressure between the treatments with 10-mg azilsartan and 8-mg candesartan cilexetil was -1.7 mm Hg, with the two-sided 95% confidence interval (CI) ranged from -3.2 to -0.2 mm Hg. The upper boundary of the 95% CI was below the margin of 2.5 mm Hg, confirming the non-inferiority of 10-mg azilsartan to 8-mg candesartan cilexetil. The difference also reached significance (P=0.037). The corresponding difference in diastolic blood pressure was -1.4 (95% CI: -2.4 to -0.4) mm Hg (P=0.006). Treatment with 10-mg azilsartan was similar to 8-mg candesartan cilexetil in its association with rare adverse events. In conclusion, 10-mg azilsartan was non-inferior to 8-mg candesartan cilexetil for controlling systolic blood pressure in Japanese hypertensive patients already being treated with 8-mg candesartan cilexetil.

  7. A prospective, randomized crossover study comparing direct inspection by light microscopy versus projected images for teaching of hematopathology to medical students.

    Science.gov (United States)

    Carlson, Aaron M; McPhail, Ellen D; Rodriguez, Vilmarie; Schroeder, Georgene; Wolanskyj, Alexandra P

    2014-01-01

    Instruction in hematopathology at Mayo Medical School has evolved from instructor-guided direct inspection under the light microscope (laboratory method), to photomicrographs of glass slides with classroom projection (projection method). These methods have not been compared directly to date. Forty-one second-year medical students participated in this pilot study, a prospective, randomized, crossover study measuring educational performance during a hematology pathophysiology course. The students were randomized to one of two groups. All students received the same didactic lectures in the classroom and subsequent case-based review of peripheral blood smears using either laboratory or projection methods, on day one with a crossover to the other method on day two. Pre- and post-test examinations centered on morphology recognition measured educational performance on each day, followed by a questionnaire identifying the student's favored method. There was no significant difference in the pre-test and post-test scores between the two teaching methods (rank-sum P = 0.43). Students overwhelmingly preferred the projection method and perceived it as superior (76%), although post-test scores were not significantly different. Student's recommended method was split with 50% favoring the projection method, 43% favoring a combined approach, and 23% noting logistical challenges to the laboratory. In this study, the laboratory and projection method were equivalent in terms of educational performance for hematopathology among medicals students. A classroom-based approach such as the projection method is favored, given the large class sizes in undergraduate medical education, as well as the ergonomic challenges and additional resources required for large group instruction in a laboratory setting. © 2013 American Association of Anatomists.

  8. 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

  9. TRAP: A Three-Way Handshake Server for TCP Connection Establishment

    Directory of Open Access Journals (Sweden)

    Fu-Hau Hsu

    2016-11-01

    Full Text Available Distributed denial of service attacks have become more and more frequent nowadays. In 2013, a massive distributed denial of service (DDoS attack was launched against Spamhaus causing the service to shut down. In this paper, we present a three-way handshaking server for Transmission Control Protocol (TCP connection redirection utilizing TCP header options. When a legitimate client attempted to connect to a server undergoing an SYN-flood DDoS attack, it will try to initiate a three-way handshake. After it has successfully established a connection, the server will reply with a reset (RST packet, in which a new server address and a secret is embedded. The client can, thus, connect to the new server that only accepts SYN packets with the corrected secret using the supplied secret.

  10. 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

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

    Directory of Open Access Journals (Sweden)

    T N A van den Berg

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

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

    Science.gov (United States)

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

    2015-01-01

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

  13. Simultaneous coffee caffeine intake and sleep deprivation alter glucose homeostasis in Iranian men: a randomized crossover trial.

    Science.gov (United States)

    Rasaei, Behrouz; Talib, Ruzita Abd; Noor, Mohd Ismail; Karandish, Majid; Karim, Norimah A

    2016-12-01

    Sleep deprivation and coffee caffeine consumption have been shown to affect glucose homeostasis separately, but the combined effects of these two variables are unknown. Forty-two healthy Iranian men, aged 20-40 years old, were assigned to three groups in a randomised crossover trial involving three treatments with two-week washout periods. Subjects were moderate coffee consumers (caffeine-free), and caffeinated coffee (CC treatment, without sugar, 65 mg caffeine/ cup). DC and CC treatments were blinded. At the end of each treatment, fasting serum glucose (using enzyme assays) and insulin (using electrochemiluminescence immunoassay) were measured and, again, two hours after an oral glucose tolerance test (OGTT). Insulin resistance was quantified with the homeostasis model. Repeated measures ANOVA indicated no significant difference between the treatments in fasting serum glucose (p=0.248) or insulin resistance (p=0.079). However, ANOVA demonstrated differences between treatments in fasting serum insulin (p=0.004) and glucose, as well as insulin after OGTT (pcaffeinated coffee was more adverse for glucose homeostasis compared to decaffeinated coffee in individuals who were simultaneously sleep deprived.

  14. Effects on Weight, Blood Lipids, Serum Fatty Acid Profile and Coagulation by an Energy-Dense Formula to Older Care Residents: A Randomized Controlled Crossover Trial.

    Science.gov (United States)

    Tylner, Sara; Cederholm, Tommy; Faxén-Irving, Gerd

    2016-03-01

    Dietary intake in frail old adults is often lower than estimated needs. The aim of this study was to evaluate the effects of an energy-dense oral supplement on nutritional status, food intake, and physical function in residents living in care residential homes. Randomized controlled intervention trial with a crossover design. Five care residential homes in the southern Stockholm area. Older people living at care residential homes: age 65 or older, malnourished or at risk of malnutrition according to Mini Nutritional Assessment-Short Form (MNA-SF). Energy-dense formula (oleic and linoleic acid emulsion enriched with protein and micronutrients) (Calogen Extra, Nutricia) 30 mL distributed 3 times daily for 6 weeks. Body weight, 3-day food and fluid record, appetite rating, and physical function (ie, Short Physical Performance Battery, grip strength, and peak expiratory flow). Biochemical indicators of nutritional status, blood lipids, and serum phospholipid fatty acid (FA) profile. Twenty-eight participants completed the 2 phases of the crossover study; group A (n = 14, 87 ± 6 years, 50% women) and group B (n = 14, 82 ± 8 years, 71% women). The intervention periods combined resulted in significantly (P acid based fat emulsion enriched with protein and micronutrients (Calogen Extra) 3 times daily to old people in care residential homes improved nutritional status, had positive effects on fatty acid profile and blood lipids, and a potential antithrombotic effect. CLINICALTRIALS. NCT01259999. Copyright © 2016 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

  15. Effect of moderate- versus high-intensity exercise on vascular function, biomarkers and quality of life in heart transplant recipients: A randomized, crossover trial.

    Science.gov (United States)

    Dall, Christian H; Gustafsson, Finn; Christensen, Stefan B; Dela, Flemming; Langberg, Henning; Prescott, Eva

    2015-08-01

    Growing evidence in long-term treatment of heart transplant (HTx) recipients indicates effects of high-intensity interval training (HIIT) on several parameters, including oxygen uptake, vascular function and psychological distress. In this study we compare the effect of HIIT vs continued moderate training (CON) on vascular function, biomarkers and health-related quality of life (HRQoL) in HTx recipients. A randomized, controlled crossover trial of stable HTx recipients >12 months after transplantation was done on patients with 12 weeks of HIIT or 12 weeks of CON, followed by a 5-month washout and crossover. Outcomes included endothelial function, arterial stiffness, biomarkers, HRQoL and markers of anxiety and depression. Sixteen HTx recipients (mean age 52 years, 75% male) completed the study. HIIT increased VO(2peak) more than CON (between-group difference, p HIIT patients (p = 0.02) and borderline increased in CON patients (p = 0.07), whereas there was no significant effect of exercise on the mental component. Depression score decreased significantly in HIIT patients (p = 0.04) with no change in CON patients (p = 0.75), whereas anxiety score decreased significantly in both HIIT (p 0.05). Arterial stiffness and biomarkers were not changed, nor did endothelial function change after HIIT (p = 0.08) or CON (p = 0.68). HIIT and CON are both well tolerated and induce similar improvements in physical components of HRQoL and in markers of anxiety. Effects of either training modality on vascular function and biomarkers could not be confirmed. Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

  16. 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.

  17. Comparison of patient-ventilator asynchrony during pressure support ventilation and proportional assist ventilation modes in surgical Intensive Care Unit: A randomized crossover study.

    Science.gov (United States)

    Gautam, Parshotam Lal; Kaur, Gaganjot; Katyal, Sunil; Gupta, Ruchi; Sandhu, Preetveen; Gautam, Nikhil

    2016-12-01

    The patient-ventilator asynchrony is almost observed in all modes of ventilation, and this asynchrony affects lung mechanics adversely resulting in deleterious outcome. Innovations and advances in ventilator technology have been trying to overcome this problem by designing newer modes of ventilation. Pressure support ventilation (PSV) is a commonly used flow-cycled mode where a constant pressure is delivered by ventilator. Proportional assist ventilation (PAV) is a new dynamic inspiratory pressure assistance and is supposed to be better than PSV for synchrony and tolerance, but reports are still controversial. Moreover, most of these studies are conducted in chronic obstructive pulmonary disease patients with respiratory failure; the results of these studies may not be applicable to surgical patients. Thus, we proposed to do compare these two modes in surgical Intensive Care Unit (ICU) patients as a randomized crossover study. Comparison of patient-ventilator asynchrony between PSV and PAV plus (PAV+) in surgical patients while weaning. After approval by the Hospital Ethics Committee, we enrolled twenty patients from surgical ICU of tertiary care institute. The patients were ventilated with pressure support mode (PSV) and PAV+ for 12 h as a crossover from one mode to another after 6 h while weaning. Average age and weight of patients were 41.80 ± 15.20 years (mean ± standard deviation [SD]) and 66.50 ± 12.47 (mean ± SD) kg, respectively. Comparing the asynchronies between the two modes, the mean number of total asynchronous recorded breaths in PSV was 7.05 ± 0.83 and 4.35 ± 5.62, respectively, during sleep and awake state, while the same were 6.75 ± 112.24 and 10.85 ± 11.33 in PAV+. Both PSV and PAV+ modes of ventilation performed similarly for patient-ventilator synchrony in surgical patients. In surgical patients with acute respiratory failure, dynamic inspiratory pressure assistance modalities are not superior to PSV with respect to cardiorespiratory

  18. 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.

  19. A comparison of Truview EVO2 laryngoscope with Macintosh laryngoscope in routine airway management: A randomized crossover clinical trial

    Science.gov (United States)

    Arora, Suman; Sayeed, Huma; Bhardwaj, Neerja

    2013-01-01

    Background: The Truview EVO2 blade facilitates the view of vocal cords by indirect laryngoscopy and does not require the proper alignment of the oral, pharyngeal and tracheal axes as with the Macintosh blade. Methods: In a crossover fashion, we prospectively compared the view obtained at laryngoscopy with Truview EVO2 and the Macintosh blade in 110 adult patients of either sex between the age of 18 and 60 years, who were scheduled to undergo general anesthesia with endotracheal intubation. The patients were intubated with the second laryngoscope. The preoperative airway variables, laryngoscopic view, difficulty of intubation scale (IDS) score, duration of intubation, and degree of difficulty percentage of glottic opening (POGO score) of use with each laryngoscope were compared. Results: The IDS score was low and comparable between the two laryngoscopes. The laryngeal view was easy; Modified Cormack Lehane (MCL) grade 2a or less in 98.14% of the cases with the Truview laryngoscope compared to 78.7% of the cases with the Macintosh laryngoscope. Nineteen patients of MCL grade 3, one patient of grade 2b, and seven patients of grade 2a view with the Macintosh laryngoscope had MCL grade 1 view with the Truview laryngoscope. The duration of intubation was comparable between Truview and Macintosh laryngoscopes (12.1±3.8 s vs. 10.9±2.1 s). Conclusion: Truview laryngoscope performed comparably to Macintosh laryngoscope in patients with normal airway; however, the Truview laryngoscope may be a better option in difficult airway situations when the Macintosh blade fails to show the glottic opening. PMID:24015124

  20. A comparison of Truview EVO2 laryngoscope with Macintosh laryngoscope in routine airway management: A randomized crossover clinical trial

    Directory of Open Access Journals (Sweden)

    Suman Arora

    2013-01-01

    Full Text Available Background: The Truview EVO2 blade facilitates the view of vocal cords by indirect laryngoscopy and does not require the proper alignment of the oral, pharyngeal and tracheal axes as with the Macintosh blade. Methods: In a crossover fashion, we prospectively compared the view obtained at laryngoscopy with Truview EVO2 and the Macintosh blade in 110 adult patients of either sex between the age of 18 and 60 years, who were scheduled to undergo general anesthesia with endotracheal intubation. The patients were intubated with the second laryngoscope. The preoperative airway variables, laryngoscopic view, difficulty of intubation scale (IDS score, duration of intubation, and degree of difficulty percentage of glottic opening (POGO score of use with each laryngoscope were compared. Results: The IDS score was low and comparable between the two laryngoscopes. The laryngeal view was easy; Modified Cormack Lehane (MCL grade 2a or less in 98.14% of the cases with the Truview laryngoscope compared to 78.7% of the cases with the Macintosh laryngoscope. Nineteen patients of MCL grade 3, one patient of grade 2b, and seven patients of grade 2a view with the Macintosh laryngoscope had MCL grade 1 view with the Truview laryngoscope. The duration of intubation was comparable between Truview and Macintosh laryngoscopes (12.1±3.8 s vs. 10.9±2.1 s. Conclusion: Truview laryngoscope performed comparably to Macintosh laryngoscope in patients with normal airway; however, the Truview laryngoscope may be a better option in difficult airway situations when the Macintosh blade fails to show the glottic opening.

  1. Tacrolimus vs. cyclosporine eyedrops in severe cyclosporine-resistant vernal keratoconjunctivitis: A randomized, comparative, double-blind, crossover study.

    Science.gov (United States)

    Pucci, Neri; Caputo, Roberto; di Grande, Laura; de Libero, Cinzia; Mori, Francesca; Barni, Simona; di Simone, Lorena; Calvani, Annamaria; Rusconi, Franca; Novembre, Elio

    2015-05-01

    Vernal keratoconjunctivitis (VKC) is a chronic sight-threatening ocular disease. Topical cyclosporine A (Cyc) has been widely administered as a steroid-sparing drug, although in about 7-10% of cases, it has been ineffective. The purpose of this study was to evaluate the efficacy of 0.1% topical tacrolimus (Tcr) in patients with severe VKC who failed to respond to 1% Cyc eyedrops. Consecutive patients with severe, Cyc-resistant VKC were enrolled in a double-blind, comparative, crossover (DBCO) trial; all patients were treated with 1% Cyc in one eye and 0.1% Tcr in the other eye for 3 wk. After a washout period of 7 days, patients were instructed to cross over the medications for three additional weeks. Objective ocular score, subjective score, and quality-of-life questionnaires (QoLQ) were collected during the trial. Blood samples were drawn to assess several safety parameters. Thirty patients have been enrolled (mean age 9.05 ± 2.12 yr). In each of the two phases of the DBCO trial, a significant improvement in objective and subjective scores was observed in the eyes treated with 0.1% Tcr (p < 0.001). Likewise, the quality of life significantly improved despite only half the eyes being successfully treated. Serum creatinine and blood parameters were constantly within the normal range, and both blood Cyc and Tcr concentrations remained below the lowest detectable levels. Topical Tcr is very effective and safe in the short term for patients suffering from severe VKC resistant to topical Cyc. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  2. Acute effects of light and dark roasted coffee on glucose tolerance: a randomized, controlled crossover trial in healthy volunteers.

    Science.gov (United States)

    Rakvaag, Elin; Dragsted, Lars Ove

    2016-10-01

    Epidemiological evidence suggests that coffee consumption is associated with a lower risk of type 2 diabetes. Coffee contains caffeine and several other components that may modulate glucose regulation. The chlorogenic acids (CGA) in coffee have been indicated as constituents that may help to normalize the acute glucose response after a carbohydrate challenge. The aim of this study was to investigate whether two coffee beverages that differ in CGA content due to different roasting degrees will differentially affect glucose regulation. In a controlled crossover trial, 11 healthy fasted volunteers consumed 300 mL of either light (LIR) or dark (DAR) roasted coffee, or water, followed 30 min later by a 75-g oral glucose tolerance test (OGTT). Blood samples were drawn at baseline, 30, 60, and 120 min. Differences in glucose and insulin responses and insulin sensitivity index (ISI) were analyzed. The CGA and caffeine contents in the coffees were analyzed using UPLC-MS/MS. No differences in glucose area under the curve (AUC) were found between treatments. Glucose concentrations were higher at 60 min after ingestion of DAR compared with water, while ingestion of LIR showed similar glucose concentrations as ingestion of water. Insulin AUC was higher after ingestion of DAR compared with water, and both coffees raised insulin concentrations and reduced ISI compared with water, with no difference between the two coffees. Two coffees with different CGA contents did not differentially affect glucose or insulin responses during an OGTT, but both increased the insulin response compared with water.

  3. Omega-3 fatty acids improve postprandial lipemia and associated endothelial dysfunction in healthy individuals - a randomized cross-over trial.

    Science.gov (United States)

    Miyoshi, Toru; Noda, Yoko; Ohno, Yuko; Sugiyama, Hiroki; Oe, Hiroki; Nakamura, Kazufumi; Kohno, Kunihisa; Ito, Hiroshi

    2014-10-01

    Postprandial elevation of triglycerides impairs endothelial function and contributes to the development of atherosclerosis. We investigated the effects of omega-3 fatty acids on postprandial endothelial function and lipid profiles. Healthy volunteers [10] were given supplementation at 4g/day omega-3 fatty acids (or were not treated) for 4 weeks in a randomised crossover study. Postprandial levels of various lipids were monitored and endothelial function assessed by brachial artery flow-mediated dilation during fasting and after a standard cookie test. Omega-3 fatty acids reduced postprandial endothelial dysfunction compared with the control diet (flow-mediated dilation at 4h=-0.5±1.2 vs. -2.0±1.6%, P=0.03). Postprandial levels of triglycerides, apolipoprotein B-48, and remnant lipoprotein-cholesterol increased in untreated subjects, peaked at 2-4h, and returned to baseline at 8h, whereas low-density lipoprotein-cholesterol levels did not change. Supplementation with omega-3 fatty acids significantly suppressed postprandial elevation of triglycerides (incremental area under the curve=220±209 vs. 374±216mg/h/dL, P=0.04) and remnant lipoprotein-cholesterol (incremental area under the curve=21.7±13.8 vs. 13.3±12.9mg/h/dL, P=0.04). Supplementation with omega-3 fatty acids significantly suppressed the increase in triglyceride content in chylomicrons as well as in very-low-density lipoproteins from baseline to 4h after the cookie test. Omega-3 fatty acids significantly decreased postprandial triglyceride elevation and postprandial endothelial dysfunction, suggesting that omega-3 fatty acids may have vascular protective effects in postprandial state. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

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

    Science.gov (United States)

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

    2018-02-01

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

  5. Acceptability and performance of the menstrual cup in South Africa: a randomized crossover trial comparing the menstrual cup to tampons or sanitary pads.

    Science.gov (United States)

    Beksinska, Mags E; Smit, Jenni; Greener, Ross; Todd, Catherine S; Lee, Mei-ling Ting; Maphumulo, Virginia; Hoffmann, Vivian

    2015-02-01

    In low-income settings, many women and girls face activity restrictions during menses, owing to lack of affordable menstrual products. The menstrual cup (MC) is a nonabsorbent reusable cup that collects menstrual blood. We assessed the acceptability and performance of the MPower® MC compared to pads or tampons among women in a low-resource setting. We conducted a randomized two-period crossover trial at one site in Durban, South Africa, between January and November 2013. Participants aged 18-45 years with regular menstrual cycles were eligible for inclusion if they had no intention of becoming pregnant, were using an effective contraceptive method, had water from the municipal system as their primary water source, and had no sexually transmitted infections. We used a computer-generated randomization sequence to assign participants to one of two sequences of menstrual product use, with allocation concealed only from the study investigators. Participants used each method over three menstrual cycles (total 6 months) and were interviewed at baseline and monthly follow-up visits. The product acceptability outcome compared product satisfaction question scores using an ordinal logistic regression model with individual random effects. This study is registered on the South African Clinical Trials database: number DOH-27-01134273. Of 124 women assessed, 110 were eligible and randomly assigned to selected menstrual products. One hundred and five women completed all follow-up visits. By comparison to pads/tampons (usual product used), the MC was rated significantly better for comfort, quality, menstrual blood collection, appearance, and preference. Both of these comparative outcome measures, along with likelihood of continued use, recommending the product, and future purchase, increased for the MC over time. MC acceptance in a population of novice users, many with limited experience with tampons, indicates that there is a pool of potential users in low-resource settings.

  6. Treatment efficacy of sacral nerve stimulation in slow transit constipation: a two-phase, double-blind randomized controlled crossover study.

    Science.gov (United States)

    Dinning, Phil G; Hunt, Linda; Patton, Vicki; Zhang, Teng; Szczesniak, Michal; Gebski, Val; Jones, Mike; Stewart, Peter; Lubowski, David Z; Cook, Ian J

    2015-05-01

    Sacral nerve stimulation (SNS) is a potential treatment for constipation refractory to standard therapies. However, there have been no randomized controlled studies examining its efficacy. In patients with slow transit constipation, we evaluated the efficacy of suprasensory and subsensory SNS compared with sham, in a prospective, 18-week randomized, double-blind, placebo-controlled, two-phase crossover study. The primary outcome measure was the proportion of patients who, on more than 2 days/week for at least 2 of 3 weeks, reported a bowel movement associated with a feeling of complete evacuation. After 3 weeks of temporary peripheral nerve evaluation (PNE), all patients had permanent implantation and were randomized to subsensory/sham (3 weeks each) and then re-randomized to suprasensory/sham (3 weeks each) with a 2-week washout period between each arm. Daily stool dairies were kept, and quality of life (QoL; SF36) was measured at the end of each arm. Between November 2006 and March 2012, 234 constipated patients were assessed, of whom 59 were willing and deemed eligible to participate (4 male; median age 42 years). Of the 59 patients, 16 (28%) responded to PNE. Fifty-five patients went on to permanent SNS implantation. The proportion of patients satisfying the primary outcome measure did not differ between suprasensory (30%) and sham (21%) stimulations, nor between subsensory (25%) and sham (25%) stimulations. There were no significant changes in QoL scores. In patients with refractory slow transit constipation, SNS did not improve the frequency of complete bowel movements over the 3-week active period.

  7. Prospective, randomized cross-over trial to assess the ability of a dry-powder inhaler to reverse the local side effects of pressurized metered-dose inhalers.

    Science.gov (United States)

    Bhalla, R K; Watson, G; Taylor, W; Jones, A S; Roland, N J

    2008-11-01

    To determine whether a corticosteroid dry-powder inhaler could reverse the pharyngeal and laryngeal side effects produced by a corticosteroid pressurised metered-dose inhaler. Prospective, randomized, controlled, cross-over, evaluator-blinded study. University Hospital Aintree, Liverpool, United Kingdom. Thirty-seven adults recruited over a 12-month period from Ear, Nose and Throat clinics at our University hospital. Patients were randomized into three groups using a computer-generated random number list and sealed opaque envelopes. Scores were achieved on respiratory symptom and vocal performance questionnaires. Acoustic analysis was performed followed by a standardized biopsy of the posterior pharyngeal wall. Histological markers of inflammation were correlated with pharyngitis. The data were tested for normality using the Kalmogorov-Smirnov test. The Kruskal-Wallis analysis of variance was used to investigate differences between medians and ranges. The data were further investigated for correlations using the Spearman test. Discriminant analysis was used to examine the effect of the three groups on each variable. Discomfort scores (median and range) were significantly lower after dry-powder inhaler use than with either a spacer or water gargle (p inhaler therapy. The reduction in pharyngitis in each of the three groups was not significant. Vocal performance scores improved with dry-powder inhaler use. Jitter, shimmer, and closed-phase quotient scores improved with dry-powder inhaler use (p inhaler was restored (p 0.01). A dry-powder inhaler may alleviate the local side effects produced by a pressurized metered-dose inhaler. Laryngeal dysfunction appears to be particularly responsive to the absence of propellant. More observational and randomized controlled trials are necessary to examine existing inhalers and specifically, how and why they cause local side effects.

  8. Is it always necessary to apply botulinum toxin into the lower facial muscles in hemifacial spasm?: a randomized, single-blind, crossover trial.

    Science.gov (United States)

    Colakoglu, Beril Donmez; Cakmur, Raif; Uzunel, Fatma

    2011-01-01

    Botulinum toxin (BTX) injections are accepted as safe and efficacious in the treatment of hemifacial spasm (HFS), but it is still debated whether BTX treatment of lower facial muscles should be performed or not. The study aims to evaluate the necessity of BTX administration into lower facial muscles in patients with HFS. A randomized, single-blind, crossover, clinical trial was conducted. Twenty-three HFS patients were randomly allocated to two different application methods. The patients were administered BTX type A into both the orbicularis oculi and perioral muscles in the first method and BTX type A into the orbicularis oculi but placebo into the perioral muscles in the second method. Subjects were crossed over to the alternate method when they needed BTX injection with a minimum of 3 months' duration. All the patients underwent both methods with no change in the total dose of BTX. All the patients benefited from BTX treatment regardless of the methods. However, in the patients with severe lower facial muscle involvement, the application of BTX into both orbicularis oculi and lower facial muscles led to better results. Our data suggest that BTX application to lower facial muscles might not be necessary in patients with mild lower facial involvement. Copyright © 2011 S. Karger AG, Basel.

  9. 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.

  10. The efficacy of music therapy protocols for decreasing pain, anxiety, and muscle tension levels during burn dressing changes: a prospective randomized crossover trial.

    Science.gov (United States)

    Tan, Xueli; Yowler, Charles J; Super, Dennis M; Fratianne, Richard B

    2010-01-01

    The purpose of this study was to explore the efficacy of two music therapy protocols on pain, anxiety, and muscle tension levels during dressing changes in burn patients. Twenty-nine inpatients participated in this prospective, crossover randomized controlled trial. On two consecutive days, patients were randomized to receive music therapy services either on the first or second day of the study. On control days, they received no music. On music days, patients practiced music-based imagery (MBI), a form of music-assisted relaxation with patient-specific mental imagery before and after dressing changes. Also, on music days during dressing changes, the patients engaged in music alternate engagement (MAE), which consisted of active participation in music making. The dependent variables were the patients' subjective ratings of their pain and anxiety levels and the research nurse's objective ratings of their muscle tension levels. Two sets of data were collected before, three sets during, and another two sets after dressing changes. The results showed significant decrease in pain levels before (P music therapy in contrast to control days. Music therapy was also associated with a decrease in anxiety and muscle tension levels during the dressing changes (P Music therapy significantly decreases the acute procedural pain, anxiety, and muscle tension levels associated with daily burn care.

  11. Effects of regular consumption of vitamin C-rich or polyphenol-rich apple juice on cardiometabolic markers in healthy adults: a randomized crossover trial.

    Science.gov (United States)

    Soriano-Maldonado, Alberto; Hidalgo, María; Arteaga, Patricia; de Pascual-Teresa, Sonia; Nova, Esther

    2014-12-01

    The aim of the present study was to investigate the effects of the consumption of two cloudy apple juices with different polyphenol and vitamin C contents on antioxidant status, cardiometabolic and inflammation markers in healthy young adults. Twenty subjects, aged 21-29 years, completed a randomized crossover study. At each 4-week intervention period, the volunteers randomly consumed two glasses (2 × 250 mL/day) of either a vitamin C-rich apple juice (VCR) (60 mg/L vitamin C and 510 mg catechin equivalent/L) or a polyphenol-rich (PR) juice (22 mg/L vitamin C and 993 mg catechin equivalent/L). Blood and urine samples were collected throughout the study, and markers of antioxidant status, glucose metabolism, lipid profile and inflammation were measured. The comparison of the post-intervention minus pre-intervention change revealed differential results in HOMA index, total cholesterol, ICAM-1 and VCAM-1 (P apple juice natural antioxidants such as vitamin C and polyphenols might provide mild favorable effects on cardiometabolic markers, as compared to apple polyphenols alone.

  12. Music and biological stress dampening in mechanically-ventilated patients at the intensive care unit ward-a prospective interventional randomized crossover trial.

    Science.gov (United States)

    Beaulieu-Boire, Genevieve; Bourque, Solange; Chagnon, Frederic; Chouinard, Lucie; Gallo-Payet, Nicole; Lesur, Olivier

    2013-08-01

    To evaluate the impact of slow-tempo music listening periods in mechanically ventilated intensive care unit patients. A randomized crossover study was performed in a 16-bed, adult critical care unit at a tertiary care hospital. Still-sedated patients, mandating at least 3 more days of mechanical ventilation, were included. The intervention consisted in two 1-hour daily periods of music-vs-sham-MP3 listening which were performed on Day 1 or 3 post-inclusion, with a Day 2 wash-out. "Before-after" collection of vital signs, recording of daily sedative drug consumption and measurement of stress and inflammatory blood markers were performed. Of 55 randomized patients, 49 were included in the final analyses. Along with music listening, (i) vital signs did not consistently change, whereas narcotic consumption tended to decrease to a similar sedation (P = .06 vs sham-MP3); (ii) cortisol and prolactin blood concentrations decreased, whereas Adreno Cortico Trophic Hormone (ACTH)/cortisol ratio increased (P = .02; P = .038; and P = .015 vs sham-MP3, respectively), (iii) cortisol responders exhibited reversed associated changes in blood mehionine (MET)-enkephalin content (P = .01). In the present trial, music listening is a more sensitive stress-reliever in terms of biological vs clinical response. The hypothalamus-pituitary adrenal axis stress axis is a quick sensor of music listening in responding mechanically ventilated intensive care unit patients, through a rapid reduction in blood cortisol. Copyright © 2013 Elsevier Inc. All rights reserved.

  13. Is the timing of caloric intake associated with variation in diet-induced thermogenesis and in the metabolic pattern? A randomized cross-over study.

    Science.gov (United States)

    Bo, S; Fadda, M; Castiglione, A; Ciccone, G; De Francesco, A; Fedele, D; Guggino, A; Parasiliti Caprino, M; Ferrara, S; Vezio Boggio, M; Mengozzi, G; Ghigo, E; Maccario, M; Broglio, F

    2015-12-01

    Food-induced thermogenesis is generally reported to be higher in the morning, although contrasting results exist because of differences in experimental settings related to the preceding fasting, exercise, sleeping and dieting. To definitively answer to this issue, we compared the calorimetric and metabolic responses to identical meals consumed at 0800 hours and at 2000 hours by healthy volunteers, after standardized diet, physical activity, duration of fast and resting. Twenty subjects (age range 20-35 years, body mass index=19-26 kg m(-)(2)) were enrolled to a randomized cross-over trial. They randomly received the same standard meal in the morning and, 7 days after, in the evening, or vice versa. A 30-min basal calorimetry was performed; a further 60-min calorimetry was done 120-min after the beginning of the meal. Blood samples were drawn every 30-min for 180-min. General linear models, adjusted for period and carry-over, were used to evaluate the 'morning effect', that is, the difference of morning delta (after-meal minus fasting values) minus evening delta (after-meal minus fasting values) of the variables. Fasting resting metabolic rate (RMR) did not change from morning to evening; after-meal RMR values were significantly higher after the morning meal (1916; 95% confidence interval (CI)=1792, 2041 vs 1756; 1648, 1863 kcal; Pmetabolic pattern of healthy individuals. The timing of meals should probably be considered when nutritional recommendations are given.

  14. 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.

  15. Comparison of the effect of aspirin and amantadine for the treatment of fatigue in multiple sclerosis: a randomized, blinded, crossover study.

    Science.gov (United States)

    Shaygannejad, Vahid; Janghorbani, Mohsen; Ashtari, Fereshteh; Zakeri, Hasanali

    2012-11-01

    The purpose of this study was to compare the relative efficacy of acetylsalicylic acid (ASA) and amantadine for the treatment of fatigue in multiple sclerosis (MS). A 10-week, randomized double-blind crossover clinical trial conducted from October 2009 to September 2010. Fifty-two patients with MS presenting fatigue at 21 to 53 years of age were randomly allocated to the two treatment groups. The first group received amantadine (100 mg twice daily) for a total of 4 weeks. The second group received ASA (500 mg once daily) for four weeks. After a 2-week washout period, they crossed over to the alternative treatment for 4 weeks. Patients were rated at baseline and the end of each phase with the Fatigue Severity Scale (FSS). ASA appeared to be equivalent in efficacy and safety to amantadine. A significant decrease in FSS occurred in both groups. Of the 26 patients treated with amantadine, the mean (SD) of FSS decreased from 4·8 (1·4) to 4·0 (1·4) (Pamantadine significantly reduce MS-related fatigue. Both ASA and amantadine have previously been shown to reduce fatigue, and we postulate that treatment with ASA and amantadine may have similar benefits.

  16. Acute Garcinia mangostana (mangosteen) supplementation does not alleviate physical fatigue during exercise: a randomized, double-blind, placebo-controlled, crossover trial.

    Science.gov (United States)

    Chang, Chih-Wei; Huang, Tzu-Zung; Chang, Wen-Hsin; Tseng, Yi-Chun; Wu, Yu-Tse; Hsu, Mei-Chich

    2016-01-01

    The purple mangosteen (Garcinia mangostana), known as the "queen of fruit," is widely consumed and unique not only because of its outstanding appearance and flavor but also its remarkable and diverse pharmacological effects. The aim of the present study is to evaluate the effect of acute mangosteen supplementation on physical fatigue during exercise. A randomized, double-blind, placebo-controlled, crossover study was carried out by 12 healthy adults. The participants were randomly assigned to receive acute oral administration of either 250 mL of the mangosteen-based juice (supplementation treatment; 305 mg of α-mangostin and 278 mg of hydroxycitric acid) or a placebo (control treatment) 1 h before cycle ergometer exercise. Time to exhaustion, heart rate, Borg Rating of Perceived Exertion score, blood biochemical markers (namely ammonia, cortisol, creatine kinase, aspartate aminotransferase, alanine aminotransferase, glucose, and lactate), muscle dynamic stiffness, and Profile of Mood States (POMS) were evaluated and recorded. The results showed all parameters we examined were significantly altered by the exercise challenge, which demonstrated they directly reflected the condition of fatigue. However, there were no differences between the two treatments besides a positive impact on the POMS examination. The occurrence of physical fatigue depends on multiple underlying mechanisms. We concluded that acute mangosteen supplementation had no impact on alleviating physical fatigue during exercise.

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

    Science.gov (United States)

    Tawasri, Patcharanee; Ampasavate, Chadarat; Tharatha, Somsak

    2016-01-01

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

  18. Efficacy evaluation of a pollen blocker cream against dust-mite allergy: A multicenter, randomized, double-blind, placebo-controlled crossover trial.

    Science.gov (United States)

    Li, Yanqing; Cheng, Lei; Chen, Xiaoning; Yang, Beibei; Wang, Dehui

    2015-01-01

    To further evaluate the efficacy and safety of a pollen blocker cream against dust-mite allergy. A multicenter, randomized, double-blind, placebo-controlled, crossover trial was conducted in a Chinese population. Patients diagnosed with perennial allergic rhinitis, sensitive to dust-mite allergy including Dermatophagoides farinae and Dermatophagoides pteronyssinus were randomly allocated to receive a pollen blocker cream or placebo, which was applied and spread evenly to the lower internal nose region three times daily for a total of 30 days. The primary outcome measurements for efficacy were total nasal symptom score (TNSS) and individual nasal symptom score (iNSS). Adverse events were also monitored. After application of a pollen blocker, the mean TNSS decreased from 23.1 to 13.8, the decrease of the pollen blocker group (9.3) was highly significant compared with the placebo group (5.2; p 0.05), and no severe systematic reactions were observed. Pollen Blocker is a safe and effective alternative to the drugs for treatment of AR, especially for Chinese people allergic to dust-mite allergy.

  19. Instant Oatmeal Increases Satiety and Reduces Energy Intake Compared to a Ready-to-Eat Oat-Based Breakfast Cereal: A Randomized Crossover Trial.

    Science.gov (United States)

    Rebello, Candida J; Johnson, William D; Martin, Corby K; Han, Hongmei; Chu, Yi-Fang; Bordenave, Nicolas; van Klinken, B Jan Willem; O'Shea, Marianne; Greenway, Frank L

    2016-01-01

    Foods that enhance satiety can help consumers to resist environmental cues to eat and help adherence to calorie restriction. The objective of this study was to compare the effect of 2 oat-based breakfast cereals on appetite, satiety, and food intake. Forty-eight healthy individuals, 18 years of age or older, were enrolled in a randomized, crossover trial. Subjects consumed isocaloric servings of either oatmeal or an oat-based ready-to-eat breakfast cereal (RTEC) in random order at least a week apart. Visual analogue scales measuring appetite and satiety were completed before breakfast and throughout the morning. Lunch was served 4 hours after breakfast. The physicochemical properties of oat soluble fiber (β-glucan) were determined. Appetite and satiety responses were analyzed by area under the curve. Food intake and β-glucan properties were analyzed using t tests. Oatmeal increased fullness (p = 0.001) and reduced hunger (p = 0.005), desire to eat (p = 0.001), and prospective intake (p = 0.006) more than the RTEC. Energy intake at lunch was lower after eating oatmeal compared to the RTEC (p = 0.012). Oatmeal had higher viscosity (p = 0.03), β-glucan content, molecular weight (p Oatmeal suppresses appetite, increases satiety, and reduces energy intake compared to the RTEC. The physicochemical properties of β-glucan and sufficient hydration of oats are important factors affecting satiety and subsequent energy intake.

  20. Feasibility and preliminary efficacy of the effects of flavanoid-rich purple grape juice on the vascular health of childhood cancer survivors: a randomized, controlled crossover trial.

    Science.gov (United States)

    Blair, Cindy K; Kelly, Aaron S; Steinberger, Julia; Eberly, Lynn E; Napurski, Char; Robien, Kim; Neglia, Joseph P; Mulrooney, Daniel A; Ross, Julie A

    2014-12-01

    Childhood cancer survivors have an increased risk of developing cardiovascular disease following treatment, yet few interventions have been evaluated to reduce this risk. Purple grape juice (pGJ), a rich source of flavonoids with antioxidant properties, has been shown in adults to reduce oxidative stress and improve endothelial function. We examined the effects of supplementing meals with pGJ on microvascular endothelial function and markers of oxidative stress and inflammation in 24 cancer survivors (ages 10-21 years). In a randomized controlled crossover trial consisting of two, 4 week intervention periods, each preceded by a 4 week washout period, subjects received in random order 6 ounces twice daily of pGJ and clear apple juice (cAJ; similar in calories but lower in flavonoids). Measurements were obtained before and after each supplementation period; change was evaluated using mixed effects ANOVA. pGJ did not improve endothelial function, measured using digital reactive hyperemia, compared with cAJ (mean change: pGJ 0.06, cAJ 0.22; difference of mean change [95% CI]: -0.16 [-0.42 - 0.11], P = 0.25). No significant changes in plasma concentrations of oxidized-LDL, myeloperoxidase, or high sensitivity C-reactive protein were observed. After 4 weeks of daily consumption of flavonoid-rich pGJ, no measurable change in vascular function was observed in these childhood cancer survivors. © 2014 Wiley Periodicals, Inc.

  1. A Feasibility Randomized Controlled Crossover Trial of Home-Based Warm Footbath to Improve Sleep in the Chronic Phase of Traumatic Brain Injury.

    Science.gov (United States)

    Chiu, Hsiao-Yean; Lin, En-Yuan; Chiu, Hsiao-Ting; Chen, Pin-Yuan

    2017-12-01

    Sleep disturbance is a common complaint after traumatic brain injury (TBI). The aim of this study was to examine the effects of a home-based warm footbath intervention on sleep in patients with TBI. This was a randomized controlled crossover study, and 23 adults with TBI were recruited and randomized to receive first a 30-minute, 41°C warm footbath and then a usual care, or vice versa, with each lasting 3 days and separated by a 3-day washout. Sleep efficiency, sleep onset latency (SOL), total sleep time, and wake after sleep onset (WASO) were assessed by actigraphy. We found that home-based warm footbath significantly had a reduced SOL (difference, -5.11 minutes) and a suppressed WASO (difference, -2.57 minutes) compared with those of usual care, but not in sleep efficiency and total sleep time. No adverse effect was reported. This study suggested that home-based warm footbath is practical and effective in relieving post-TBI sleep disturbances, particular in SOL and WASO. Nurses can use home-based warm footbath as an effective intervention for management of sleep disturbances after TBI.

  2. Orange pomace improves postprandial glycemic responses: an acute, randomized, placebo-controlled, double-blind, crossover trial in overweight men

    Science.gov (United States)

    Orange pomace (OP), a fiber-rich byproduct of juice production, has the potential for being formulated into a variety of food products. We hypothesized that OP would diminish postprandial glycemic responses to a high carbohydrate/fat breakfast and lunch. We conducted an acute, randomized, placebo-co...

  3. DNA Three Way Junction Core Decorated with Amino Acids-Like Residues-Synthesis and Characterization

    Directory of Open Access Journals (Sweden)

    Claudia Addamiano

    2016-08-01

    Full Text Available Construction and physico-chemical behavior of DNA three way junction (3WJ functionalized by protein-like residues (imidazole, alcohol and carboxylic acid at unpaired positions at the core is described. One 5′-C(S-propargyl-thymidine nucleotide was specifically incorporated on each strand to react through a post synthetic CuACC reaction with either protected imidazolyl-, hydroxyl- or carboxyl-azide. Structural impacts of 5′-C(S-functionalization were investigated to evaluate how 3WJ flexibility/stability is affected.

  4. Balanced crystalloids versus saline in the intensive care unit: study protocol for a cluster-randomized, multiple-crossover trial.

    Science.gov (United States)

    Semler, Matthew W; Self, Wesley H; Wang, Li; Byrne, Daniel W; Wanderer, Jonathan P; Ehrenfeld, Jesse M; Stollings, Joanna L; Kumar, Avinash B; Hernandez, Antonio; Guillamondegui, Oscar D; May, Addison K; Siew, Edward D; Shaw, Andrew D; Bernard, Gordon R; Rice, Todd W

    2017-03-16

    Saline, the intravenous fluid most commonly administered to critically ill adults, contains a high chloride content, which may be associated with acute kidney injury and death. Whether using balanced crystalloids rather than saline decreases the risk of acute kidney injury and death among critically ill adults remains unknown. The Isotonic Solutions and Major Adverse Renal Events Trial (SMART) is a pragmatic, cluster-level allocation, cluster-level crossover trial being conducted between 1 June 2015 and 30 April 2017 in five intensive care units at Vanderbilt University Medical Center in Nashville, TN, USA. SMART compares saline (0.9% sodium chloride) with balanced crystalloids (clinician's choice of lactated Ringer's solution or Plasma-Lyte A®). Each intensive care unit is assigned to provide either saline or balanced crystalloids each month, with the assigned crystalloid alternating monthly over the course of the trial. All adults admitted to participating intensive care units during the study period are enrolled and followed until hospital discharge or 30 days after enrollment. The anticipated enrollment is approximately 14,000 patients. The primary outcome is Major Adverse Kidney Events within 30 days-the composite of in-hospital death, receipt of new renal replacement therapy, or persistent renal dysfunction (discharge creatinine ≥200% of baseline creatinine). Secondary clinical outcomes include in-hospital mortality, intensive care unit-free days, ventilator-free days, vasopressor-free days, and renal replacement therapy-free days. Secondary renal outcomes include new renal replacement therapy receipt, persistent renal dysfunction, and incidence of stage 2 or higher acute kidney injury. This ongoing pragmatic trial will provide the largest and most comprehensive comparison to date of clinical outcomes with saline versus balanced crystalloids among critically ill adults. For logistical reasons, SMART was prospectively registered separately for the medical

  5. Pharmacokinetic interaction between udenafil and dapoxetine: a randomized, open-labeled crossover study in healthy male volunteers

    Directory of Open Access Journals (Sweden)

    Kim YH

    2015-02-01

    Full Text Available Yo Han Kim,1 Hee Youn Choi,1 Shi Hyang Lee,1 Hae Sun Jeon,1 Hyeong-Seok Lim,1 Mi Young Bahng,2 Kyun-Seop Bae1 1Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, College of Medicine, University of Ulsan, 2Clinical Development Department, Dong-A ST Co, Ltd, Seoul, Republic of Korea Background: “Udenafil” is a phosphodiesterase-5 inhibitor indicated for erectile dysfunction. “Dapoxetine” is a serotonin transport inhibitor indicated for premature ejaculation. The aim of the study reported here was to investigate the pharmacokinetic drug interaction between udenafil and dapoxetine in healthy male subjects. Methods: An open-label, three-treatment, six-sequence, three-period crossover study was performed in healthy male subjects. In varying sequences, each subjects received single oral doses of udenafil 200 mg, dapoxetine 60 mg, and both treatments. The periods were separated by a washout period of 7 days. Serial blood samples were collected up to 48 hours after dosing. The plasma concentrations of udenafil and dapoxetine were determined using a validated liquid chromatography-tandem mass spectrometry method. Pharmacokinetic parameters were obtained by non-compartmental analysis. Tolerability was assessed throughout the study. Results: Twenty-three healthy subjects completed the study. The geometric mean ratios of the area under the plasma concentration–time curve from time 0 to last measurable time point and measured peak plasma concentration for udenafil were 0.923 (90% confidence interval [CI]: 0.863–0.987 and 0.864 (90% CI: 0.789–0.947, respectively. The geometric mean ratios of the area under the plasma concentration–time curve from time 0 to last measurable time point and measured peak plasma concentration for dapoxetine were 1.125 (90% CI: 1.044–1.213 and 0.837 (90% CI: 0.758–0.925, respectively. There were no serious adverse events reported, and none of the subjects dropped out due to adverse events

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

    Science.gov (United States)

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

    2017-11-01

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

  7. A randomized crossover comparison between the Laryngeal Mask Airway-Unique™ and the air-Q intubating laryngeal airway in children.

    Science.gov (United States)

    Jagannathan, Narasimhan; Sohn, Lisa E; Mankoo, Ravinder; Langen, Kenneth E; Mandler, Tessa

    2012-02-01

    The purpose of this randomized crossover study was to evaluate the feasibility of the air-Q intubating laryngeal airway (ILA) in clinical practice when compared with the Laryngeal Mask Airway-Unique(™) (LMA-U), the current standard of care for primary airway maintenance. We hypothesized that the ILA would have better airway seal pressures and laryngeal alignment than the LMA-U in anesthetized nonparalyzed children. The ILA is a newer supraglottic airway for children with design features that allow it to be used for primary airway maintenance and as a conduit for tracheal intubations. Fifty healthy children, 6-36 months of age, 10-15 kg, who were scheduled for elective surgery in which the use of a size two LMA-U and size 1.5 ILA would be appropriate for airway maintenance, were enrolled into this randomized crossover study. Primary outcome measures were airway leak pressures and fiberoptic grades of view. Secondary outcome measures included ease and time for successful insertion, incidence of gastric insufflation, ventilation parameters, and complications. There were no statistically significant differences in regard to the ease of device insertion, time to ventilation, gastric insufflation, and ventilation parameters between the ILA and the LMA-U. All devices were successfully placed on the first attempt, and there were no instances of failure. There were statistically significant differences in the airway leak pressure between the ILA (19.0 ± 5.4 cmH(2)O) and the LMA-U (16.1 ± 4.9 cmH(2)O), P = 0.001. There were also statistically significant differences in the fiberoptic grades of view between the ILA and LMA-U, P = 0.004. The ILA had higher airway leak pressures and superior fiberoptic grades of view when compared with the LMA-U and can be a suitable alternative to the LMA-U in children weighing 10-15 kg. © 2011 Blackwell Publishing Ltd.

  8. Pomegranate juice, but not an extract, confers a lower glycemic response on a high-glycemic index food: randomized, crossover, controlled trials in healthy subjects.

    Science.gov (United States)

    Kerimi, Asimina; Nyambe-Silavwe, Hilda; Gauer, Julia S; Tomás-Barberán, Francisco A; Williamson, Gary

    2017-10-11

    Background: Low-glycemic index diets have demonstrated health benefits associated with a reduced risk of developing type 2 diabetes.Objectives: We tested whether pomegranate polyphenols could lower the glycemic response of a high-glycemic index food when consumed together and the mechanism by which this might occur.Design: We compared the acute effect of a pomegranate juice and a polyphenol-rich extract from pomegranate (supplement) on the bread-derived postprandial blood glucose concentration in 2 randomized, crossover, controlled studies (double-blinded for the supplements), each on 16 healthy volunteers. An additional randomized, crossover, controlled study on 16 volunteers consuming constituent fruit acids in a pH-balanced solution (same pH as pomegranate) and bread was conducted to determine any contributions to postprandial responses caused by acidic beverages.Results: As primary outcome, the incremental area under the curve for bread-derived blood glucose (-33.1% ± 18.1%, P = 0.000005) and peak blood glucose (25.4% ± 19.3%, P = 0.0004) were attenuated by pomegranate juice, compared with a control solution containing the equivalent amount of sugars. In contrast, the pomegranate supplement, or a solution containing the malic and citric acid components of the juice, was ineffective. The pomegranate polyphenol punicalagin was a very effective inhibitor of human α-amylase in vitro, comparable to the drug acarbose. Neither the pomegranate extract nor the individual component polyphenols inhibited 14C-D-glucose transport across differentiated Caco-2/TC7 cell monolayers, but they inhibited uptake of 14C-glucose into Xenopus oocytes expressing the human glucose transporter type 2. Further, some of the predicted pomegranate gut microbiota metabolites modulated 14C-D-glucose and 14C-deoxy-D-glucose uptake into hepatic HepG2 cells.Conclusions: These data indicate that pomegranate polyphenols, when present in a beverage but not in a supplement, can reduce the

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

    Science.gov (United States)

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

    2017-07-01

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

  10. A procedure for isolating social desirability variance in a three-way component analysis.

    Science.gov (United States)

    Lorenzo-Seva, Urbano; Ferrando, Pere J

    2012-02-01

    Three-way component analysis aims to summarize all the information in a three-way data set related, for example, to the responses of individuals to a set of items in a set of situations. The data are decomposed into three component matrices (person, item and situation components) and a core matrix. Such data are generally obtained by means of a situation-response questionnaire administered to a sample of participants. This paper proposes a preprocessing procedure for controlling social desirability in these kinds of questionnaires. The essential idea is to isolate the variance due to social desirability response bias and remove it from the data set. The procedure is demonstrated through its empirical application in the personality domain. Its performance is also assessed by means of a simulation study which shows that the presence of social desirability bias in a data set had different consequences: (1) the variance effect due to persons increased, and the effect of the triple interaction persons × items × situations decreased; (2) the person component and core matrix were partially distorted. However, the social desirability bias in the data set was successfully controlled by our preprocessing method. © 2011 The British Psychological Society.

  11. Effect of high-dose plerixafor on CD34+ cell mobilization in healthy stem cell donors: results of a randomized crossover trial.

    Science.gov (United States)

    Pantin, Jeremy; Purev, Enkhtsetseg; Tian, Xin; Cook, Lisa; Donohue-Jerussi, Theresa; Cho, Elena; Reger, Robert; Hsieh, Matthew; Khuu, Hanh; Calandra, Gary; Geller, Nancy L; Childs, Richard W

    2017-03-01

    Hematopoietic stem cells can be mobilized from healthy donors using single-agent plerixafor without granulocyte colony-stimulating factor and, following allogeneic transplantation, can result in sustained donor-derived hematopoiesis. However, when a single dose of plerixafor is administered at a conventional 240 μg/kg dose, approximately one-third of donors will fail to mobilize the minimally acceptable dose of CD34+ cells needed for allogeneic transplantation. We conducted an open-label, randomized trial to assess the safety and activity of high-dose (480 μg/kg) plerixafor in CD34+ cell mobilization in healthy donors. Subjects were randomly assigned to receive either a high dose or a conventional dose (240 μg/kg) of plerixafor, given as a single subcutaneous injection, in a two-sequence, two-period, crossover design. Each treatment period was separated by a 2-week minimum washout period. The primary endpoint was the peak CD34+ count in the blood, with secondary endpoints of CD34+ cell area under the curve (AUC), CD34+ count at 24 hours, and time to peak CD34+ following the administration of plerixafor. We randomized 23 subjects to the two treatment sequences and 20 subjects received both doses of plerixafor. Peak CD34+ count in the blood was significantly increased (mean 32.2 versus 27.8 cells/μL, P=0.0009) and CD34+ cell AUC over 24 hours was significantly increased (mean 553 versus 446 h cells/μL, Phealthy donors and mobilizes greater numbers of CD34+ cells than conventional-dose plerixafor, which may improve CD34+ graft yields and reduce the number of apheresis procedures needed to collect sufficient stem cells for allogeneic transplantation. (ClinicalTrials.gov, identifier: NCT00322127). Copyright© Ferrata Storti Foundation.

  12. Effect of Ginkgo biloba on visual field and contrast sensitivity in Chinese patients with normal tension glaucoma: a randomized, crossover clinical trial.

    Science.gov (United States)

    Guo, Xinxing; Kong, Xiangbin; Huang, Rui; Jin, Ling; Ding, Xiaohu; He, Mingguang; Liu, Xing; Patel, Mehul Chimanlal; Congdon, Nathan G

    2014-01-07

    We evaluated the effect of ginkgo biloba extract on visual field defect and contrast sensitivity in a Chinese cohort with normal tension glaucoma. In this prospective, randomized, placebo-controlled crossover study, patients newly diagnosed with normal tension glaucoma, either in a tertiary glaucoma clinic (n = 5) or in a cohort undergoing routine general physical examinations in a primary care clinic (n = 30), underwent two 4-week phases of treatment, separated by a washout period of 8 weeks. Randomization determined whether ginkgo biloba extract (40 mg, 3 times per day) or placebo (identical-appearing tablets) was received first. Primary outcomes were change in contrast sensitivity and mean deviation on 24-2 SITA standard visual field testing, while secondary outcomes included IOP and self-reported adverse events. A total of 35 patients with mean age 63.7 (6.5) years were randomized to the ginkgo biloba extract-placebo (n = 18) or the placebo-ginkgo biloba extract (n = 17) sequence. A total of 28 patients (80.0%, 14 in each group) who completed testing did not differ at baseline in age, sex, visual field mean deviation, contrast sensitivity, IOP, or blood pressure. Changes in visual field and contrast sensitivity did not differ by treatment received or sequence (P > 0.2 for all). Power to have detected a difference in mean defect as large as previously reported was 80%. In contrast to some previous reports, ginkgo biloba extract treatment had no effect on mean defect or contrast sensitivity in this group of normal tension glaucoma patients. (http://www.chictr.org number, ChiCTR-TRC-08000724).

  13. Effect of extended-release dexmethylphenidate and mixed amphetamine salts on sleep: a double-blind, randomized, crossover study in youth with attention-deficit hyperactivity disorder.

    Science.gov (United States)

    Santisteban, J A; Stein, M A; Bergmame, L; Gruber, R

    2014-09-01

    We sought to determine the dose-response effects of extended-release (ER) dexmethylphenidate (d-MPH) and ER mixed amphetamine salts (MAS) on objective measures of sleep. This was an 8-week, double-blind, placebo-controlled, randomized, two period, crossover study of youth with attention-deficit hyperactivity disorder (ADHD) as confirmed by the Kiddie Schedule for Affective Disorders for School-Age Children-Present and Lifetime version (K-SADS-PL). Children aged 10-17 years were recruited from clinical practice, colleague referrals, and flyers. Participants were randomized to initially receive either d-MPH or MAS. During each 4-week drug period, children received three dose levels (10, 20, and 25/30 mg) in ascending order, with placebo substituted for active medication in a randomized fashion during 1 week of the study. After 4 weeks, participants were switched to the alternative medication for another 4 weeks of treatment. The main outcome measure was sleep duration as measured by actigraphy. Children, parents, and researchers were blinded to drug, dose, and placebo status. Sixty-five participants met the inclusion criteria and were enrolled in the study. Of these, 37 participants with sufficient sleep data for analysis were included. Sleep schedule measures showed a significant effect for dose on sleep start time (F(1,36) = 6.284; p sleep start time when children were receiving 20- or 30-mg doses, compared with placebo (p sleep duration (F(1,36) = 8.112; p sleep duration for subjects receiving 30 mg compared with those receiving placebo (p sleep duration or sleep schedule between the two stimulant medications. The trial is complete and closed to follow-up. Higher stimulant doses were associated with reduced sleep duration and later sleep start times, regardless of medication class. ClinicalTrials.gov: NCT00393042.

  14. Efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (USMART) program among patients with mild cognitive impairment: a randomized controlled crossover trial.

    Science.gov (United States)

    Han, Ji Won; Son, Kyung Lak; Byun, Hye Jin; Ko, Ji Won; Kim, Kayoung; Hong, Jong Woo; Kim, Tae Hyun; Kim, Ki Woong

    2017-06-06

    Spaced retrieval training (SRT) is a nonpharmacological intervention for mild cognitive impairment (MCI) and dementia that trains the learning and retention of target information by recalling it over increasingly long intervals. We recently developed the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (USMART) program as a convenient, self-administered tablet-based SRT program. We also demonstrated the utility of USMART for improving memory in individuals with MCI through an open-label uncontrolled trial. This study had an open-label, single-blind, randomized, controlled, two-period crossover design. Fifty patients with MCI were randomized into USMART-usual care and usual care-USMART treatment sequences. USMART was completed or usual care was provided biweekly over a 4-week treatment period with a 2-week washout period between treatment periods. Primary outcome measures included the Word List Memory Test, Word List Recall Test (WLRT), and Word List Recognition Test. Outcomes were measured at baseline, week 5, and week 11 by raters who were blinded to intervention type. An intention-to-treat analysis and linear mixed modeling were used. Of 50 randomized participants, 41 completed the study (18% dropout rate). The USMART group had larger improvements in WLRT score (effect size = 0.49, p = 0.031) than the usual care group. There were no significant differences in other primary or secondary measures between the USMART and usual care groups. Moreover, no USMART-related adverse events were reported. The 4-week USMART modestly improved information retrieval in older people with MCI, and was well accepted with minimal technical support. ClinicalTrials.gov NCT01688128 . Registered 12 September 2012.

  15. Estimation of diffusion properties in three-way fiber crossings without overfitting

    Science.gov (United States)

    Yang, Jianfei; Poot, Dirk H. J.; van Vliet, Lucas J.; Vos, Frans M.

    2015-12-01

    Diffusion-weighted magnetic resonance imaging permits assessment of the structural integrity of the brain’s white matter. This requires unbiased and precise quantification of diffusion properties. We aim to estimate such properties in simple and complex fiber geometries up to three-way fiber crossings using rank-2 tensor model selection. A maximum a-posteriori (MAP) estimator is employed to determine the parameters of a constrained triple tensor model. A prior is imposed on the parameters to avoid the degeneracy of the model estimation. This prior maximizes the divergence between the three tensor’s principal orientations. A new model selection approach quantifies the extent to which the candidate models are appropriate, i.e. a single-, dual- or triple-tensor model. The model selection precludes overfitting to the data. It is based on the goodness of fit and information complexity measured by the total Kullback-Leibler divergence (ICOMP-TKLD). The proposed framework is compared to maximum likelihood estimation on phantom data of three-way fiber crossings. It is also compared to the ball-and-stick approach from the FMRIB Software Library (FSL) on experimental data. The spread in the estimated parameters reduces significantly due to the prior. The fractional anisotropy (FA) could be precisely estimated with MAP down to an angle of approximately 40° between the three fibers. Furthermore, volume fractions between 0.2 and 0.8 could be reliably estimated. The configurations inferred by our method corresponded to the anticipated neuro-anatomy both in single fibers and in three-way fiber crossings. The main difference with FSL was in single fiber regions. Here, ICOMP-TKLD predominantly inferred a single fiber configuration, as preferred, whereas FSL mostly selected dual or triple order ball-and-stick models. The prior of our MAP estimator enhances the precision of the parameter estimation, without introducing a bias. Additionally, our model selection effectively

  16. Comparative pharmacokinetic profiles of a novel isotretinoin formulation (isotretinoin-Lidose) and the innovator isotretinoin formulation: a randomized, 4-treatment, crossover study.

    Science.gov (United States)

    Webster, Guy F; Leyden, James J; Gross, Jason A

    2013-11-01

    A high-fat meal is needed for optimal absorption of isotretinoin. A new formulation of isotretinoin, which enhances absorption of isotretinoin in the absence of dietary fat, has recently been approved by the Food and Drug Administration (FDA). We sought to compare the pharmacokinetic profiles of a new formulation of isotretinoin (isotretinoin-Lidose) with the innovator isotretinoin formulation. This study was an open-label, single-dose, randomized, 4-treatment, crossover comparative trial between a new and innovator formulation of isotretinoin in the fasting and fed states. Both formulations were bioequivalent under fed conditions. As expected in a fasting state, absorption of both formulations was reduced. A considerable difference between the 2 drugs occurred under fasted conditions-there was a marked improvement in overall bioavailability of the isotretinoin-Lidose formulation. Mean plasma levels of the isotretinoin-Lidose formulation during fasting reached 66.8% of that observed with a fatty meal, and those of the isotretinoin formulation only reached 39.6% of that observed with a fatty meal. Only the FDA-stipulated standard high-fat, high-calorie meal of 50-g fat was studied in the fed state. Isotretinoin-Lidose formulation is bioequivalent to the innovator formulation under fed conditions with regard to its pharmacokinetic profile but delivers twice as much isotretinoin and 4-oxo-isotretinoin when administered after an overnight fast. Copyright © 2013 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

  17. Improvement of hypertension, endothelial function and systemic inflammation following short-term supplementation with red beet (Beta vulgaris L.) juice: a randomized crossover pilot study.

    Science.gov (United States)

    Asgary, S; Afshani, M R; Sahebkar, A; Keshvari, M; Taheri, M; Jahanian, E; Rafieian-Kopaei, M; Malekian, F; Sarrafzadegan, N

    2016-10-01

    Hypertension is a major risk factor for cardiovascular disease and has a prevalence of about one billion people worldwide. It has been shown that adherence to a diet rich in fruits and vegetables helps in decreasing blood pressure (BP). This study aimed to investigate the effect of raw beet juice (RBJ) and cooked beet (CB) on BP of hypertensive subjects. In this randomized crossover study, 24 hypertensive subjects aged 25-68 years old were divided into two groups. One group took RBJ for 2 weeks and the other group took CB. After 2 weeks of treatment, both groups had a washout for 2 weeks then switched to the alternate treatment. Each participant consumed 250 ml day(-1) of RBJ or 250 g day(-1) of CB each for a period of 2 weeks. Body weight, BP, flow-mediated dilation (FMD), lipid profile and inflammatory parameters were measured at baseline and after each period. According to the results, high-sensitivity C-reactive protein (hs-CRP) and tumour necrosis factor alpha (TNF-α) were significantly lower and FMD was significantly higher after treatment with RBJ compared with CB (Pcholesterol (TC) were decreased with RBJ but not with CB. Although both forms of beetroot were effective in improving BP, endothelial function and systemic inflammation, the raw beetroot juice had greater antihypertensive effects. Also more improvement was observed in endothelial function and systemic inflammation with RBJ compared with CB.

  18. 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 Lycopene 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. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  19. The effects of transcutaneous electrical nerve stimulation on strength, proprioception, balance and mobility in people with stroke: a randomized controlled cross-over trial.

    Science.gov (United States)

    Tyson, Sarah F; Sadeghi-Demneh, Ebrahim; Nester, Christopher J

    2013-09-01

    To investigate the feasibility and potential efficacy of 'activeTENS' (that is transcutaneous electrical nerve stimulation (TENS) during everyday activities) by assessing the immediate effects on strength, proprioception, balance/falls risk and mobility after stroke. A paired-sample randomized cross-over trial. Twenty-nine mobile chronic stroke survivors with no pre-existing conditions limiting balance or mobility or contra-indications to TENS. University clinical research facility. A single session of 'activeTENS' delivered via a 'sock electrode' (70-130 Hz, five second cycle) plus a session of control treatment (wearing the sock electrode with no stimulation), lasting approximately two hours in total. Dorsiflexor and plantarflexor strength and proprioception using an isokinetic dyanometer, balance and falls risk (Standing Forward Reach Test) and gait speed (10-m walk test). All participants tolerated 'active TENS'. Most parameters improved during stimulation with activeTENS; balance (p = 0.009), gait speed (p = 0.002), plantarflexor strength (p = 0.008) and proprioception of plantarflexion (p = 0.029), except dorsiflexor strength (p = 0.194) and dorsiflexion proprioception (p = 0.078). The results provide initial evidence of the potential of 'active TENS' to benefit physical function after stroke which warrants further phase II trials to develop the intervention. Concerns that stimulation could have a detrimental impact on balance and increase risk of falls were not supported.

  20. Effects of mood inductions by meal ambiance and moderate alcohol consumption on endocannabinoids and N-acylethanolamines in humans: a randomized crossover trial.

    Directory of Open Access Journals (Sweden)

    Ilse C Schrieks

    Full Text Available The endocannabinoid system is suggested to play a regulatory role in mood. However, the response of circulating endocannabinoids (ECs to mood changes has never been tested in humans. In the present study, we examined the effects of mood changes induced by ambiance and moderate alcohol consumption on plasma ECs 2-arachidonoylglycerol (2-AG, anandamide (AEA, and some N-acylethanolamine (NAE congeners in humans.Healthy women (n = 28 participated in a randomized cross-over study. They consumed sparkling white wine (340 mL; 30 g alcohol or alcohol-free sparkling white wine (340 mL; <2 g alcohol as part of a standard evening meal in a room with either a pleasant or an unpleasant ambiance.Plasma concentrations of palmitoylethanolamide (PEA and stearoylethanolamide (SEA increased after 30 min in the unpleasant ambiance, while they decreased in the pleasant ambiance. Changes in ECs and their NAE congeners correlated with mood states, such as happiness and fatigue, but in the pleasant ambiance without alcohol only. ECs and their NAE congeners were correlated with serum free fatty acids and cortisol.This is the first human study to demonstrate that plasma NAEs are responsive to an unpleasant meal ambiance. Furthermore, associations between mood states and ECs and their NAE congeners were observed.Clinicaltrials.gov NCT01426022.

  1. 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.

  2. A comparison of regular consumption of fresh lean pork, beef and chicken on body composition: a randomized cross-over trial.

    Science.gov (United States)

    Murphy, Karen J; Parker, Barbara; Dyer, Kathryn A; Davis, Courtney R; Coates, Alison M; Buckley, Jonathan D; Howe, Peter R C

    2014-02-14

    Pork is the most widely eaten meat in the world and recent evidence shows that diets high in pork protein, with and without energy restriction, may have favourable effects on body composition. However, it is unclear whether these effects on body composition are specific to pork or whether consumption of other high protein meat diets may have the same benefit. Therefore we aimed to compare regular consumption of pork, beef and chicken on indices of adiposity. In a nine month randomised open-labelled cross-over intervention trial, 49 overweight or obese adults were randomly assigned to consume up to 1 kg/week of pork, chicken or beef, in an otherwise unrestricted diet for three months, followed by two further three month periods consuming each of the alternative meat options. BMI and waist/hip circumference were measured and body composition was determined using dual energy x-ray absorptiometry. Dietary intake was assessed using three day weighed food diaries. Energy expenditure was estimated from activity diaries. There was no difference in BMI or any other marker of adiposity between consumption of pork, beef and chicken diets. Similarly there were no differences in energy or nutrient intakes between diets. After three months, regular consumption of lean pork meat as compared to that of beef and chicken results in similar changes in markers of adiposity of overweight and obese Australian middle-aged men and women.

  3. BounceBack™ capsules for reduction of DOMS after eccentric exercise: a randomized, double-blind, placebo-controlled, crossover pilot study

    Directory of Open Access Journals (Sweden)

    Singh Betsy B

    2009-06-01

    Full Text Available Abstract Background Delayed onset muscle soreness (DOMS is muscle pain and discomfort experienced approximately one to three days after exercise. DOMS is thought to be a result of microscopic muscle fiber tears that occur more commonly after eccentric exercise rather than concentric exercise. This study sought to test the efficacy of a proprietary dietary supplement, BounceBack™, to alleviate the severity of DOMS after standardized eccentric exercise. Methods The study was a randomized, double-blind, placebo-controlled, crossover study. Ten healthy community-dwelling untrained subjects, ranging in age from 18–45 years, were enrolled. Mean differences within and between groups were assessed inferentially at each data collection time-point using t-tests for all outcome measures. Results In this controlled pilot study, intake of BounceBack™ capsules for 30 days resulted in a significant reduction in standardized measures of pain and tenderness post-eccentric exercise compared to the placebo group. There were trends towards reductions in plasma indicators of inflammation (high sensitivity C-reactive protein and muscle damage (creatine phosphokinase and myoglobin. Conclusion BounceBack™ capsules were able to significantly reduce standardized measures of pain and tenderness at several post-eccentric exercise time points in comparison to placebo. The differences in the serological markers of DOMS, while not statistically significant, appear to support the clinical findings. The product appears to have a good safety profile and further study with a larger sample size is warranted based on the current results.

  4. Impact of equol-producing capacity and soy-isoflavone profiles of supplements on bone calcium retention in postmenopausal women: a randomized crossover trial.

    Science.gov (United States)

    Pawlowski, Jessica W; Martin, Berdine R; McCabe, George P; McCabe, Linda; Jackson, George S; Peacock, Munro; Barnes, Stephen; Weaver, Connie M

    2015-09-01

    Postmenopausal estrogen depletion is a major contributing factor to bone loss. Soy isoflavones have variable effects on the prevention of postmenopausal bone loss, which is possibly related to the specific isoflavone content or the variable equol-producing capacity of individuals. We aimed to determine the effects of the content of isoflavones in a soy supplement and the equol-producing ability of the individual on postmenopausal bone calcium retention. The study was a blinded, randomized, crossover intervention trial in 24 postmenopausal women who were prescreened for their ability to convert daidzein to equol. Women were equilibrated with (41)Ca before the intervention. Interventions were 5 soy isoflavone oral supplements (2 doses of a genistein-rich soy supplement and 3 doses of mixed isoflavones in various proportions) and a bisphosphonate (risedronate). Each intervention was given sequentially for 50 d followed by a 50-d washout period. The percentage of bone calcium retention was determined from the change in urinary (41)Ca:calcium. Interventions that ranged from 52 to 220 mg total isoflavones/d increased bone calcium retention between 3.4% and 7.6% (P equol producers and nonproducers. Soy isoflavones, although not as potent as risedronate, are effective bone-preserving agents in postmenopausal women regardless of their equol-producing status, and mixed isoflavones in their natural ratios are more effective than enriched genistein. This trial was registered at clinicaltrials.gov as NCT00244907. © 2015 American Society for Nutrition.

  5. Impact of equol-producing capacity and soy-isoflavone profiles of supplements on bone calcium retention in postmenopausal women: a randomized crossover trial12

    Science.gov (United States)

    Pawlowski, Jessica W; Martin, Berdine R; McCabe, George P; McCabe, Linda; Jackson, George S; Peacock, Munro; Barnes, Stephen; Weaver, Connie M

    2015-01-01

    Background: Postmenopausal estrogen depletion is a major contributing factor to bone loss. Soy isoflavones have variable effects on the prevention of postmenopausal bone loss, which is possibly related to the specific isoflavone content or the variable equol-producing capacity of individuals. Objective: We aimed to determine the effects of the content of isoflavones in a soy supplement and the equol-producing ability of the individual on postmenopausal bone calcium retention. Design: The study was a blinded, randomized, crossover intervention trial in 24 postmenopausal women who were prescreened for their ability to convert daidzein to equol. Women were equilibrated with 41Ca before the intervention. Interventions were 5 soy isoflavone oral supplements (2 doses of a genistein-rich soy supplement and 3 doses of mixed isoflavones in various proportions) and a bisphosphonate (risedronate). Each intervention was given sequentially for 50 d followed by a 50-d washout period. The percentage of bone calcium retention was determined from the change in urinary 41Ca:calcium. Results: Interventions that ranged from 52 to 220 mg total isoflavones/d increased bone calcium retention between 3.4% and 7.6% (P equol producers and nonproducers. Conclusion: Soy isoflavones, although not as potent as risedronate, are effective bone-preserving agents in postmenopausal women regardless of their equol-producing status, and mixed isoflavones in their natural ratios are more effective than enriched genistein. This trial was registered at clinicaltrials.gov as NCT00244907. PMID:26245807

  6. 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.

  7. Acute effects of pea protein and hull fibre alone and combined on blood glucose, appetite, and food intake in healthy young men--a randomized crossover trial.

    Science.gov (United States)

    Mollard, Rebecca C; Luhovyy, Bohdan L; Smith, Christopher; Anderson, G Harvey

    2014-12-01

    Whether pulse components can be used as value-added ingredients in foods formulated for blood glucose (BG) and food intake (FI) control requires investigation. The objective of this study was to examine of the effects of pea components on FI at an ad libitum meal, as well as appetite and BG responses before and after the meal. In a repeated-measures crossover trial, men (n = 15) randomly consumed (i) pea hull fibre (7 g), (ii) pea protein (10 g), (iii) pea protein (10 g) plus hull fibre (7 g), (iv) yellow peas (406 g), and (v) control. Pea hull fibre and protein were served with tomato sauce and noodles, while yellow peas were served with tomato sauce. Control was noodles and tomato sauce. FI was measured at a pizza meal (135 min). Appetite and BG were measured pre-pizza (0-135 min) and post-pizza (155-215 min). Protein plus fibre and yellow peas led to lower pre-pizza BG area under the curve compared with fibre and control. At 30 min, BG was lower after protein plus fibre and yellow peas compared with fibre and control, whereas at 45 and 75 min, protein plus fibre and yellow peas led to lower BG compared with fibre (p peas led to lower BG compared with fibre (p supports the use of pea components as value-added ingredients in foods designed to improve glycemic control.

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

    Directory of Open Access Journals (Sweden)

    Omar ePatiño-Rodríguez

    2015-01-01

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

  9. A randomized two-way crossover bioequivalence study in healthy adult volunteers of paediatric zidovudine/lamivudine/nevirapine fast-disintegrating fixed-dose combination tablet.

    Science.gov (United States)

    Joshi, Anjali; Gbadero, Daniel; Esseku, Fredrick; Adesanya, Olufikayo J; Adeyeye, Moji C

    2017-04-01

    The bioequivalence study was conducted to compare the developed paediatric fixed-dose combination (FDC) zidovudine/lamivudine/nevirapine (60/30/50 mg) tablet - the test formulation - with the combined mixture of single-entity innovator products (reference product). A single-dose open-label randomized two-way crossover study was conducted in healthy adult African volunteers after an informed consent was obtained. The 24 volunteers, divided into two groups, were administered the products after an overnight fast on two treatment days with 14 days of washout period. Blood samples were collected for 96 h and analysed using a validated RP-HPLC-UV assay method. Pharmacokinetic (PK) parameters (non-compartmental model) were assessed with WinNonlin® software. Analysis of variance (ANOVA) and FDA bioequivalence statistical criterion of 90% CI or 80% to 125% range (set at P 0.05). The 90% CIs for all the drugs were within the 80% to 125% range. The developed FDC tablet is bioequivalent to the reference product. © 2016 Royal Pharmaceutical Society.

  10. Average bioequivalence of single 500 mg doses of two oral formulations of levofloxacin: a randomized, open-label, two-period crossover study in healthy adult Brazilian volunteers

    Directory of Open Access Journals (Sweden)

    Eunice Kazue Kano

    2015-03-01

    Full Text Available Average bioequivalence of two 500 mg levofloxacin formulations available in Brazil, Tavanic(c (Sanofi-Aventis Farmacêutica Ltda, Brazil, reference product and Levaquin(c (Janssen-Cilag Farmacêutica Ltda, Brazil, test product was evaluated by means of a randomized, open-label, 2-way crossover study performed in 26 healthy Brazilian volunteers under fasting conditions. A single dose of 500 mg levofloxacin tablets was orally administered, and blood samples were collected over a period of 48 hours. Levofloxacin plasmatic concentrations were determined using a validated HPLC method. Pharmacokinetic parameters Cmax, Tmax, Kel, T1/2el, AUC0-t and AUC0-inf were calculated using noncompartmental analysis. Bioequivalence was determined by calculating 90% confidence intervals (90% CI for the ratio of Cmax, AUC0-t and AUC0-inf values for test and reference products, using logarithmic transformed data. Tolerability was assessed by monitoring vital signs and laboratory analysis results, by subject interviews and by spontaneous report of adverse events. 90% CIs for Cmax, AUC0-t and AUC0-inf were 92.1% - 108.2%, 90.7% - 98.0%, and 94.8% - 100.0%, respectively. Observed adverse events were nausea and headache. It was concluded that Tavanic(c and Levaquin(c are bioequivalent, since 90% CIs are within the 80% - 125% interval proposed by regulatory agencies.

  11. Self-esteem treatment in anxiety: A randomized controlled crossover trial of Eye Movement Desensitization and Reprocessing (EMDR) versus Competitive Memory Training (COMET) in patients with anxiety disorders.

    Science.gov (United States)

    Staring, A B P; van den Berg, D P G; Cath, D C; Schoorl, M; Engelhard, I M; Korrelboom, C W

    2016-07-01

    Little is known about treating low self-esteem in anxiety disorders. This study evaluated two treatments targeting different mechanisms: (1) Eye Movement Desensitization and Reprocessing (EMDR), which aims to desensitize negative memory representations that are proposed to maintain low self-esteem; and (2) Competitive Memory Training (COMET), which aims to activate positive representations for enhancing self-esteem. A Randomized Controlled Trial (RCT) was used with a crossover design. Group 1 received six sessions EMDR first and then six sessions COMET; group 2 vice versa. Assessments were made at baseline (T0), end of first treatment (T1), and end of second treatment (T2). Main outcome was self-esteem. We included 47 patients and performed Linear Mixed Models. COMET showed more improvements in self-esteem than EMDR: effect-sizes 1.25 versus 0.46 post-treatment. Unexpectedly, when EMDR was given first, subsequent effects of COMET were significantly reduced in comparison to COMET as the first intervention. For EMDR, sequence made no difference. Reductions in anxiety and depression were mediated by better self-esteem. COMET was associated with significantly greater improvements in self-esteem than EMDR in patients with anxiety disorders. EMDR treatment reduced the effectiveness of subsequent COMET. Improved self-esteem mediated reductions in anxiety and depression symptoms. Copyright © 2016 Elsevier Ltd. All rights reserved.

  12. Reduction of nasal volume after allergen-induced rhinitis in patients treated with rupatadine: a randomized, cross-over, double-blind, placebo-controlled study.

    Science.gov (United States)

    Valero, A; Serrano, C; Bartrá, J; Izquierdo, I; Muñoz-Cano, R; Mullol, J; Picado, C

    2009-01-01

    To measure the reduction in nasal obstruction using acoustic rhinometry in patients with allergic rhinitis treated with rupatadine. We performed a randomized, double-blind, cross-over, placebo-controlled clinical trial in asymptomatic patients with allergic rhinitis. Patients received rupatadine 10 mg or placebo once daily for 3 days, in 2 subsequent periods separated by a washout interval of 14 days. We performed a nasal allergen challenge during each period, and measured nasal volume using acoustic rhinometry and nasal nitric oxide (nNO) at baseline, and at 2 hours and 24 hours after the challenge. We also evaluated nasal symptoms (rhinorrhea, itching, obstruction, and sneezing), as well as total symptom score (T4SS) at the same time points as for the primary objective. The study population comprised 30 outpatients with a mean (SD) age of 28 (10) years. Nasal airway blockage was significantly lower in the rupatadine group than in the placebo group (47%, P rupatadine-treated patients remained unaltered, unlike in the placebo-treated group, where levels decreased at 2 hours. After treatment with rupatadine, patients showed a lower decrease in the mean total symptoms score at 2 hours (3.6 [2.6]) compared with placebo (3.9 [2.9]), although these differences did not achieve statistical significance. Overall, rupatadine was well tolerated and no serious or unexpected adverse events were observed. Rupatadine 10 mg can reduce nasal obstruction assessed by objective measures and is well tolerated in patients with allergic rhinitis.

  13. Rupatadine does not potentiate the CNS depressant effects of lorazepam: randomized, double-blind, crossover, repeated dose, placebo-controlled study.

    Science.gov (United States)

    García-Gea, Consuelo; Ballester, Maria Rosa; Martínez, Juan; Antonijoan, Rosa Maria; Donado, Esther; Izquierdo, Iñaki; Barbanoj, Manuel-José

    2010-06-01

    The main objective was to assess whether benzodiazepine intake when rupatadine plasma concentrations were at steady-state would increase the CNS depressant effects. Rupatadine is a new H(1)-antihistamine which also inhibits platelet activating factor (PAF) release and has been shown to be clinically effective at doses of 10 mg. Sixteen healthy young volunteers took part in a crossover, randomized, double-blind, placebo controlled trial comprising two experimental periods (repeated administration for 7 days of rupatadine 10 mg or placebo as single oral daily doses, separated by a washout of 14 days). On days 5 and 7, according to a fully balanced design, a single oral dose of lorazepam 2 mg or placebo was added. CNS effects were evaluated on these days by seven objective tests of psychomotor performance and eight subjective visual analogue scales (VAS) at pre-dose and several times after drug intake. Four treatment conditions were evaluated: placebo, rupatadine 10 mg, lorazepam 2 mg and rupatadine 10 mg + lorazepam 2 mg. Significant CNS effects, either impairment of psychomotor performance or subjective sedation, were observed when lorazepam was administered, either alone or in combination with steady state concentrations of rupatadine. No significant differences were found between these two conditions. In addition, rupatadine was not different from placebo. All treatments were well tolerated. Repeated doses of rupatadine (10 mg orally) did not enhance the CNS depressant effects of lorazepam (2 mg orally, single dose) either in objective psychomotor tasks or in subjective evaluations.

  14. Efficacy of a Nasal Spray from Citrus limon and Cydonia oblonga for the Treatment of Hay Fever Symptoms-A Randomized, Placebo Controlled Cross-Over Study.

    Science.gov (United States)

    Hoffmann, A; Klein, S D; Gründemann, C; Garcia-Käufer, M; Wolf, U; Huber, R

    2016-09-01

    Nasal spray from lemon and quince (LQNS) is used to treat hay fever symptoms and has been shown to inhibit histamine release from mast cells in vitro. Forty-three patients with grass pollen allergy (GPA) were randomized to be treated either with placebo or LQNS for one week, respectively, in a cross-over study. At baseline and after the respective treatments patients were provoked with grass pollen allergen. Outcome parameters were nasal flow measured with rhinomanometry (primary), a nasal symptom score, histamine in the nasal mucus and tolerability. In the per protocol population absolute inspiratory nasal flow 10 and 20 min after provocation was higher with LQNS compared to placebo (-37 ± 87 mL/s; p = 0.027 and -44 ± 85 mL/s; p = 0.022). The nasal symptom score showed a trend (3.3 ± 1.8 in the placebo and 2.8 ± 1.5 in the LQNS group; p = 0.070) in favor of LQNS; the histamine concentration was not significantly different between the groups. Tolerability of both, LQNS and placebo, was rated as very good. LQNS seems to have an anti-allergic effect in patients with GPA. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  15. The Short-Term Effects of Transcranial Direct Current Stimulation on Electroencephalography in Children with Autism: A Randomized Crossover Controlled Trial

    Directory of Open Access Journals (Sweden)

    Anuwat Amatachaya

    2015-01-01

    Full Text Available Abnormal synaptic maturation and connectivity are possible etiologies of autism. Previous studies showed significantly less alpha activity in autism than normal children. Therefore, we studied the effects of anodal tDCS on peak alpha frequency (PAF related to autism treatment evaluation checklist (ATEC. Twenty male children with autism were randomly assigned in a crossover design to receive a single session of both active and sham tDCS stimulation (11 mA over F3 (left dorsolateral prefrontal cortex. Pre- to postsession changes in a measure of cortical activity impacted by tDCS (PAF and ATEC were compared between groups. We also examined the associations between pre- and postsession changes in the PAF and ATEC. The results show significant pre- to postsession improvements in two domains of ATEC (social and health/behavior domains following active tDCS, relative to sham treatment. PAF also significantly increased at the stimulation site, and an increase in PAF was significantly associated with improvements in the two domains of ATEC impacted by tDCS. The findings suggest that a single session of anodal tDCS over the F3 may have clinical benefits in children with autism and that those benefits may be related to an increase in PAF.

  16. Manual Closed-Loop Insulin Delivery Using a Saddle Point Model Predictive Control Algorithm: Results of a Crossover Randomized Overnight Study.

    Science.gov (United States)

    Guilhem, Isabelle; Penet, Maxime; Paillard, Anaïs; Carpentier, Marc; Esvant, Annabelle; Lefebvre, Marie-Anne; Poirier, Jean-Yves

    2017-09-01

    The purpose was to assess the efficacy of a new closed-loop algorithm (Saddle Point Model Predictive Control, SP-MPC) in achieving nocturnal normoglycemia while reducing the risk of hypoglycemia in patients with type 1 diabetes. In this randomized crossover study, 10 adult patients (mean hemoglobin A1c 7.35 ± 1.04%) were assigned to be treated overnight by open loop using sensor-augmented pump therapy (open-loop SAP) or manual closed-loop delivery. During closed loop, insulin doses were calculated using the SP-MPC algorithm and administered as manual boluses every 15 minutes from 9:00 pm to 8:00 am. Patients consumed a self-selected meal (65-125 g of carbohydrates) at 7:00 pm accompanied by their usual prandial bolus. Blood glucose was measured every 30 minutes. The primary endpoints were the time spent in target (70-145 mg/dl) and time spent below 70 mg/dl from 11:00 pm to 8:00 am. Time spent in target did not differ between closed-loop and open-loop SAP. The number of hypoglycemic events (145 mg/dl was significantly lower during closed-loop than during open-loop SAP ( P = .03) as well as HBGI ( P = .02). This pilot study suggests that the use of the SP-MPC algorithm may improve mean overnight glucose control and reduce the number of hypoglycemic events as compared to SAP therapy.

  17. [Use of the size 3 ProSeal laryngeal mask airway in children. Results of a randomized crossover investigation with the Classic laryngeal mask airway].

    Science.gov (United States)

    Goldmann, K; Roettger, C; Wulf, H

    2006-02-01

    The low-pressure airway seal of the Classic laryngeal mask airway (CLMA) can be inadequate for positive pressure ventilation (PPV) in children. The ProSeal laryngeal mask airway (PLMA) forms a more effective seal of the airway than the CLMA and facilitates gastric tube placement in adults. The size 3 PLMA can be used in adults and children. The CLMA and PLMA were studied in random order -- crossover -- in 30 anaesthetized, non-paralysed children (average age 10.6 years, average body weight 39 kg). Airway leak pressure, maximum tidal volume, ease of insertion, quality of initial airway and fiberoptic position were determined. Gastric tube placement was assessed for the PLMA. The mean airway leak pressure in neutral head position (27.0 vs. 16.8 cm H(2)O), maximum flexion (38.3 vs. 26.2 cm H(2)O) and maximum extension (21.1 vs. 14.2 cm H(2)O) as well as the mean maximum tidal volume (1432 vs. 1062 ml) were significantly higher (pairway leak pressure seem to make the size 3 PLMA a more suitable device for PPV in children than the same size CLMA.

  18. Comparison of Compliance and Intervention Outcomes Between Hip- and Wrist-Worn Accelerometers During a Randomized Crossover Trial of an Active Video Games Intervention in Children.

    Science.gov (United States)

    Howie, Erin K; McVeigh, Joanne A; Straker, Leon M

    2016-09-01

    There are several practical issues when considering the use of hip-worn or wrist-worn accelerometers. This study compared compliance and outcomes between hip- and wrist-worn accelerometers worn simultaneously by children during an active video games intervention. As part of a larger randomized crossover trial, participants (n = 73, age 10 to 12 years) wore 2 Actical accelerometers simultaneously during waking hours for 7 days, on the hip and wrist. Measurements were repeated at 4 timepoints: 1) at baseline, 2) during traditional video games condition, 3) during active video games condition, 4) during no video games condition. Compliance and intervention effects were compared between hip and wrist. There were no statistically significant differences at any timepoint in percentage compliance between hip (77% to 87%) and wrist (79% to 89%). Wrist-measured counts (difference of 64.3 counts per minute, 95% CI 4.4-124.3) and moderate-to-vigorous physical activity (MVPA) (12 min/day, 95% CI 0.3-23.7) were higher during the no video games condition compared with the traditional video games condition. There were no differences in hip-measured counts per minute or MVPA between conditions or sedentary time for hip or wrist. There were no differences in compliance between hip- and wrist-worn accelerometers during an intervention trial, however, intervention findings differed between hip and wrist.

  19. Effect of a mouthrinse containing rice peptide CL(14-25) on early dental plaque regrowth: a randomized crossover pilot study.

    Science.gov (United States)

    Takayama, Saori; Kato, Tetsuo; Imamura, Kentaro; Kita, Daichi; Ota, Koki; Suzuki, Eiichi; Sugito, Hiroki; Saitoh, Eiichi; Taniguchi, Masayuki; Saito, Atsushi

    2015-10-03

    We aimed to evaluate clinically the effect of mouthrinse containing a rice peptide on early dental plaque regrowth. The study was designed as a double-masked, two-group crossover randomized pilot trial, involving 10 periodontally healthy volunteers. After receiving a professional tooth cleaning at baseline, over the next 3 days each participant refrained from all oral hygiene measures and had two daily rinses with 20 ml of the test mouthrinse containing 0.4 % rice peptide CL(14-25) or placebo rinse. At the end of each experimental period, plaque score was assessed using the modified Volpe's method, and the participants filled out a questionnaire. Each participant underwent a 7-day washout period followed by a second allocation. The plaque score was the primary outcome of the study and participant perception was the secondary outcome. No adverse effects were observed in the participants during the study. Clinically, the mean plaque score of the examined teeth was significantly lower in the test group (2.44 ± 0.74, CI: 1.91-2.96) than the placebo group (2.65 ± 0.63, CI: 2.20-3.10) (P plaque. However, clinical relevance of this efficacy needs to be validated in a future large-scale study. UMIN Clinical Trials Registry (UMIN-CTR) R000014000. Date of formal registration: November 1, 2013.

  20. Topical diclofenac does not affect the antiplatelet properties of aspirin as compared to the intermediate effects of oral diclofenac: A prospective, randomized, complete crossover study.

    Science.gov (United States)

    Rowcliffe, M; Nezami, B; Westphal, E S; Rainka, M; Janda, M; Bates, V; Gengo, F

    2016-04-01

    Nonsteroidal anti-inflammatory drugs (NSAIDs) adversely interact with aspirin, diminishing its antiplatelet effect and potentially placing patients at an increased risk for recurrent thrombotic events. This crossover study aimed to determine whether the topical NSAID diclofenac epolamine 1.3% patch or oral diclofenac 50 mg interfered with the antiplatelet effects of aspirin 325 mg. Twelve healthy men and women aged 18-50 were included. Participants were randomized into 5 treatment arms: aspirin, diclofenac potassium 50 mg, diclofenac patch, diclofenac potassium plus ASA 325 mg, and diclofenac patch plus aspirin. Platelet responsiveness was determined using whole-blood impedance aggregation (WBA) to collagen 1 μg/mL and arachidonic acid (AA) 0.5 mM and was sampled every 2 hours. No significant difference in platelet function was observed following the diclofenac patch and aspirin vs aspirin alone. Oral diclofenac produced a mixed effect with significant reduction in platelet inhibition at hour 2 and hour 8 following aspirin administration. Topical diclofenac does not significantly interfere with the antiplatelet effects of aspirin and may be a safer alternative to the oral formulation. © 2015, The American College of Clinical Pharmacology.

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

    Science.gov (United States)

    Kristensen, Peter Lommer; Pedersen-Bjergaard, Ulrik; Kjær, Troels Wesenberg; Olsen, Niels Vidiendal; Dela, Flemming; Holst, Jens Juul; Faber, Jens; Tarnow, Lise; Thorsteinsson, Birger

    2013-01-01

    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.

  2. The influence of vitamin D analogs on calcification modulators, N-terminal pro-B-type natriuretic peptide and inflammatory markers in hemodialysis patients: a randomized crossover study.

    Science.gov (United States)

    Hansen, Ditte; Rasmussen, Knud; Rasmussen, Lars M; Bruunsgaard, Helle; Brandi, Lisbet

    2014-08-12

    The risk of cardiovascular disease is tremendously high in dialysis patients. Dialysis patients treated with vitamin D analogs show decreased cardiovascular morbidity and mortality compared with untreated patients. We examined the influence of two common vitamin D analogs, alfacalcidol and paricalcitol, on important cardiovascular biomarkers in hemodialysis patients. Anti-inflammatory effects and the influence on regulators of vascular calcification as well as markers of heart failure were examined. In 57 chronic hemodialysis patients enrolled in a randomized crossover trial comparing paricalcitol and alfacalcidol, we examined the changes in osteoprotegerin, fetuin-A, NT-proBNP, hs-Crp, IL-6 and TNF-α, during 16 weeks of treatment. NT-proBNP and osteoprotegerin increased comparably in the paricalcitol and alfacalcidol-treated groups. Fetuin-A increased significantly in the alfacalcidol-treated group compared with the paricalcitol-treated group (difference 32.84 μmol/l (95% C.I.; range 0.21-67.47)) during the first treatment period. No difference was found between the groups during the second treatment period, and IL-6, TNF-α and hs-Crp were unchanged in both treatment groups. Paricalcitol and alfacalcidol modulate regulators of vascular calcification. Alfacalcidol may increase the level of the calcification inhibitor fetuin-A. We did not find any anti-inflammatory effect or difference in changes of NT-proBNP. ClinicalTrials.gov NCT00469599 May 3 2007.

  3. Effect of onion peel extract supplementation on the lipid profile and antioxidative status of healthy young women: a randomized, placebo-controlled, double-blind, crossover trial.

    Science.gov (United States)

    Kim, Jungmi; Cha, Yong-Jun; Lee, Kyung-Hea; Park, Eunju

    2013-10-01

    The consumption of fruits and vegetables that have high polyphenol content has been previously associated with a reduced risk for cardiovascular disease. We investigated the effects of onion peel extract on plasma total antioxidant capacity, lipid peroxidation, and leukocyte DNA damage. This study was a randomized, double-blind, placebo-controlled, crossover trial. Healthy female subjects received either onion peel extract or placebo (dextrin) for two weeks, underwent a 1-week washout period, and then received the other treatment for an additional two weeks. After two weeks of onion peel extract supplementation, the total cholesterol level, low-density lipoprotein cholesterol level, and atherogenic index significantly decreased (P onion peel extract supplementation. Additionally, no significant difference was found in plasma antioxidant vitamin (retinol, tocopherols, carotenoids, and coenzyme Q10) levels or ex vivo H2O2-provoked oxidative DNA damage after onion peel extract supplementation. The present interventional study provides evidence of the health benefits of onion peel extract and demonstrates its effects in modulating lipid profiles in healthy young Korean women.

  4. Supplementation with a Polyphenol-Rich Extract, PerfLoad®, Improves Physical Performance during High-Intensity Exercise: A Randomized, Double Blind, Crossover Trial

    Directory of Open Access Journals (Sweden)

    Julien Cases

    2017-04-01

    Full Text Available Workout capacity is energy-production driven. To produce peak metabolic power outputs, the organism predominantly relies more on anaerobic metabolism, but this undoubtedly has a negative and limiting impact on muscle function and performance. The aim of the study was to evaluate if an innovative polyphenol-based food supplement, PerfLoad®, was able to improve metabolic homeostasis and physical performance during high-intensity exercises under anaerobic conditions. The effect of a supplementation has been investigated on fifteen recreationally-active male athletes during a randomized, double-blind and crossover clinical investigation. The Wingate test, an inducer of an unbalanced metabolism associated to oxidative stress, was used to assess maximum anaerobic power during a high-intensity exercise on a cycle ergometer. Supplementation with PerfLoad® correlated with a significant increase in total power output (5%, maximal peak power output (3.7%, and average power developed (5%, without inducing more fatigue or greater heart rate. Instead, oxidative homeostasis was stabilized in supplemented subjects. Such results demonstrated that PerfLoad® is a natural and efficient solution capable of, similarly to training benefits, helping athletes to improve their physical performance, while balancing their metabolism and reducing exercise-induced oxidative stress.

  5. 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.

  6. Effect of Pregabalin on Cardiovascular Responses to Exercise and Postexercise Pain and Fatigue in Fibromyalgia: A Randomized, Double-Blind, Crossover Pilot Study

    Directory of Open Access Journals (Sweden)

    Andrea T. White

    2015-01-01

    Full Text Available Pregabalin, an approved treatment for fibromyalgia (FM, has been shown to decrease sympathetic nervous system (SNS activity and inhibit sympathetically maintained pain, but its effects on exercise responses have not been reported. Methods. Using a randomized double-blind crossover design, we assessed the effect of 5 weeks of pregabalin (versus placebo on acute cardiovascular and subjective responses to moderate exercise in 19 FM patients. Blood pressure (BP, heart rate (HR, and ratings of perceived exertion (RPE during exercise and ratings of pain, physical fatigue, and mental fatigue before, during, and for 48 hours after exercise were compared in patients on pregabalin versus placebo and also versus 18 healthy controls. Results. On placebo, exercise RPE and BP were significantly higher in FM patients than controls (p0.26. Cardiovascular responses of nonresponders (n=7 were not altered by pregabalin. In responders, pregabalin improved ratings of fatigue and pain (p<0.04, but negative effects on pain and fatigue were seen in nonresponders. Conclusions. These preliminary findings suggest that pregabalin may normalize cardiovascular and subjective responses to exercise in many FM patients.

  7. A Comparison of Regular Consumption of Fresh Lean Pork, Beef and Chicken on Body Composition: A Randomized Cross-Over Trial

    Directory of Open Access Journals (Sweden)

    Karen J. Murphy

    2014-02-01

    Full Text Available Pork is the most widely eaten meat in the world and recent evidence shows that diets high in pork protein, with and without energy restriction, may have favourable effects on body composition. However, it is unclear whether these effects on body composition are specific to pork or whether consumption of other high protein meat diets may have the same benefit. Therefore we aimed to compare regular consumption of pork, beef and chicken on indices of adiposity. In a nine month randomised open-labelled cross-over intervention trial, 49 overweight or obese adults were randomly assigned to consume up to 1 kg/week of pork, chicken or beef, in an otherwise unrestricted diet for three months, followed by two further three month periods consuming each of the alternative meat options. BMI and waist/hip circumference were measured and body composition was determined using dual energy x-ray absorptiometry. Dietary intake was assessed using three day weighed food diaries. Energy expenditure was estimated from activity diaries. There was no difference in BMI or any other marker of adiposity between consumption of pork, beef and chicken diets. Similarly there were no differences in energy or nutrient intakes between diets. After three months, regular consumption of lean pork meat as compared to that of beef and chicken results in similar changes in markers of adiposity of overweight and obese Australian middle-aged men and women.

  8. The Effects of Soy Bean Flour Enriched Bread Intake on Anthropometric Indices and Blood Pressure in Type 2 Diabetic Women: A Crossover Randomized Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Asma Salari Moghaddam

    2014-01-01

    Full Text Available Previous studies showed that soy bean has the potential to improve many aspects of diabetes state and provide metabolic benefits that aid in weight management. We aimed to determine the effects of soy bean flour enriched bread on anthropometric indices and blood pressure among type 2 diabetic patients. This randomized, crossover, clinical trial was performed in 30 type 2 diabetic women. There were two trial periods for 6 weeks and a wash-out period for 4 weeks. In the soy bread diet period, 120 g of soy bean flour enriched bread was consumed each day instead of the same amount of their usual bread or other cereal products. After a 4-week wash-out period, participants were crossed over for another 6 weeks. Mean (±SD age of study participants was 45.7 ± 3.8 years. The results of our study showed no significant effects of soy bean flour enriched bread on anthropometric indices and blood pressure among diabetic patients. Despite the slight reduction in BMI, waist circumference, and percent of body fat, there were no significant differences in changes of these values between two groups. No significant changes in waist to hip ratio and blood pressure were seen.

  9. Dimensions of Temperament and Depressive Symptoms: Replicating a Three-Way Interaction.

    Science.gov (United States)

    Vasey, Michael W; Harbaugh, Casaundra N; Lonigan, Chistopher J; Phillips, Beth M; Hankin, Benjamin L; Willem, Lore; Bijttebier, Patricia

    2013-12-01

    High negative emotionality (NE), low positive emotionality (PE), and low self-regulatory capacity (i.e., effortful control or EC) are related to depressive symptoms and furthermore, may moderate one another's relations to such symptoms. Indeed, preliminary evidence suggests they may operate in a three-way interaction (Dinovo & Vasey, 2011), but the replicability of that finding remains unknown. Therefore, we tested this NExPExEC interaction in association with depressive symptoms in 5 independent samples. This interaction was significant in 4 of the 5 samples and a combined sample and approached significance in the fifth sample. In contrast, the NExPExEC interaction was unrelated to general anxious symptoms and thus may be specific to symptoms of depression. Implications, directions for future research, and limitations are discussed.

  10. 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.

  11. Faster reduction in hyperinflation and improvement in lung ventilation inhomogeneity promoted by aclidinium compared to glycopyrronium in severe stable COPD patients. A randomized crossover study.

    Science.gov (United States)

    Santus, Pierachille; Radovanovic, Dejan; Di Marco, Fabiano; Raccanelli, Rita; Valenti, Vincenzo; Centanni, Stefano

    2015-12-01

    Standard spyrometric assessment in chronic obstructive pulmonary disease (COPD) only evaluates bronchial obstruction. However, airflow limitation and hyperinflation are the main pathophysiological factors responsible for dyspnoea and reduced exercise tolerance in patients with COPD. This study evaluated the effects of aclidinium bromide 400 μg and glycopyrronium bromide 50 μg on these parameters. Patients with stable severe/very severe COPD were randomized in this double-blind, double-dummy, crossover, Phase IV study. Patients received single doses of each drug on separate days. Primary endpoints were changes in residual volume (RV) and intra-thoracic gas volume (ITGV), assessed by full-body plethysmography. Other endpoints included changes variations in lung ventilation inhomogeneity (Phase III slope of single-breath nitrogen washout test, SBN2), dyspnoea visual analogue scale, and pulmonary specific total airway resistances. Assessments were performed at baseline and 5, 15, 30, 60, and 180 min post-administration. Thirty-seven patients were randomized (31 male; mean age 71 years). Aclidinium and glycopyrronium significantly improved ITGV versus baseline at all-time points (p ventilation inhomogeneity versus baseline at all-time points; no significant changes were observed for glycopyrronium. For the first time two long-acting muscarinic antagonists have been compared in acute conditions with body plethysmography and SBN2 test. We demonstrated that both aclidinium and glycopyrronium significantly reduce hyperinflation and dyspnoea in severe and very severe COPD patients. Aclidinium however promoted a faster reduction in RV and was the only able to reduce lung ventilation inhomogeneity. Trial Registration numbers available on Clinicaltrials.gov: NCT02181023. Copyright © 2015 Elsevier Ltd. All rights reserved.

  12. A randomized crossover clinical study showing that methylphenidate-SODAS improves attention-deficit/hyperactivity disorder symptoms in adolescents with substance use disorder

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    C.M. Szobot

    2008-03-01

    Full Text Available Our objective was to evaluate the effectiveness of a long-acting formulation of methylphenidate (MPH-SODAS on attention-deficit/hyperactivity disorder (ADHD symptoms in an outpatient sample of adolescents with ADHD and substance use disorders (SUD. Secondary goals were to evaluate the tolerability and impact on drug use of MPH-SODAS. This was a 6-week, single-blind, placebo-controlled crossover study assessing efficacy of escalated doses of MPH-SODAS on ADHD symptoms in 16 adolescents with ADHD/SUD. Participants were randomly allocated to either group A (weeks 1-3 on MPH-SODAS, weeks 4-6 on placebo or group B (reverse order. The primary outcome measures were the Swanson, Nolan and Pelham Scale, version IV (SNAP-IV and the Clinical Global Impression Scale (CGI. We also evaluated the adverse effects of MPH-SODAS using the Barkley Side Effect Rating Scale and subject reports of drug use during the study. The sample consisted of marijuana (N = 16; 100% and cocaine users (N = 7; 43.8%. Subjects had a significantly greater reduction in SNAP-IV and CGI scores (P < 0.001 for all analyses during MPH-SODAS treatment compared to placebo. No significant effects for period or sequence were found in analyses with the SNAP-IV and CGI scales. There was no significant effect on drug use. MPH-SODAS was well tolerated but was associated with more severe appetite reduction than placebo (P < 0.001. MPH-SODAS was more effective than placebo in reducing ADHD symptoms in a non-abstinent outpatient sample of adolescents with comorbid SUD. Randomized clinical trials, with larger samples and SUD intervention, are recommended.

  13. A khorasan wheat-based replacement diet improves risk profile of patients with type 2 diabetes mellitus (T2DM): a randomized crossover trial.

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    Whittaker, Anne; Dinu, Monica; Cesari, Francesca; Gori, Anna Maria; Fiorillo, Claudia; Becatti, Matteo; Casini, Alessandro; Marcucci, Rossella; Benedettelli, Stefano; Sofi, Francesco

    2017-04-01

    The aim of the present study was to examine whether a replacement diet with products made with organic ancient khorasan wheat could provide additive protective effects in reducing glucose, insulin, lipid and inflammatory risk factors, and in restoring blood redox balance in type 2 diabetes mellitus (T2DM) patients compared to diet with product made with modern organic wheat. We conducted a randomized, double-blinded crossover trial with two intervention phases on 21 T2DM patients (14 females, 7 males). The participants were assigned to consume products (bread, pasta, crackers and biscuits) made using semi-whole flour from organic wheat that was either from ancient khorasan wheat or modern control wheat for 8 weeks in a random order. An 8-week washout period was implemented between the interventions. Laboratory analyses were performed both at the beginning and at the end of each intervention phase. The metabolic risk profile improved only after the khorasan intervention period, as measured by a reduction in total and LDL cholesterol (mean reduction: -3.7 and -3.4 %, respectively), insulin (-16.3 %) and blood glucose (-9.1 %). Similarly, there was a significant reduction in circulating levels of reactive oxygen species (ROS), vascular endothelial growth factor (VEGF) and interleukin-1ra, and a significant increase of total antioxidant capacity (+6.3 %). No significant differences from baseline were noted after the modern control wheat intervention phase. The change (from pre- to post-intervention) between the two intervention arms was significantly different (p diet with ancient khorasan wheat consumption provided additive protection in reducing total and LDL cholesterol, insulin, blood glucose, ROS production, and some inflammatory risk factors, which are all key factors warranting of control in secondary prevention of T2DM compared to a diet with products made with modern wheat.

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

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    Butacnum, Arisa; Chongsuwat, Rewadee; Bumrungpert, Akkarach

    2017-01-01

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

  15. Ticagrelor Versus Clopidogrel in Black Patients With Stable Coronary Artery Disease: Prospective, Randomized, Open-Label, Multiple-Dose, Crossover Pilot Study.

    Science.gov (United States)

    Waksman, Ron; Maya, Juan; Angiolillo, Dominick J; Carlson, Glenn F; Teng, Renli; Caplan, Richard J; Ferdinand, Keith C

    2015-07-01

    The burden of coronary artery disease (CAD) is high in blacks, highlighting the need for clinical research of antiplatelet agents in this population. We sought to evaluate platelet reactivity during loading and maintenance dosing of ticagrelor versus clopidogrel, and the pharmacokinetic profile of ticagrelor and its metabolite AR-C124910XX, in black patients with stable CAD taking low-dose aspirin (acetylsalicylic acid). In a multicenter, randomized, open-label, crossover study, 34 blacks with stable CAD receiving acetylsalicylic acid 75 to 100 mg/d were randomized to clopidogrel (600 mg, then 75 mg QD for 7-9 days) or ticagrelor (180 mg, then 90 mg BID for 7-9 days). After washout 10 to 14 days, patients switched regimens. The primary end point was platelet reactivity 2 hours post loading dose (P2Y12 reactivity units [PRU] measured by the VerifyNow assay). Least-squares mean PRU at 2 hours post loading dose was lower with ticagrelor (27.6) versus clopidogrel (211.2); least-squares mean difference was -183.6 (95% confidence interval, -213.9 to -153.3; Pticagrelor versus clopidogrel. At 2 hours post dose, the prevalence of high on-treatment platelet reactivity (≥208 PRU) was lower with ticagrelor (0%) than with clopidogrel (57.1%). Pharmacokinetic profiles of ticagrelor and AR-C124910XX were consistent with previous reports in stable CAD populations. In black patients with stable CAD receiving low-dose acetylsalicylic acid, ticagrelor provided a faster onset and greater degree of platelet inhibition than clopidogrel. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01523392. © 2015 American Heart Association, Inc.

  16. To compare PubMed Clinical Queries and UpToDate in teaching information mastery to clinical residents: a crossover randomized controlled trial.

    Science.gov (United States)

    Sayyah Ensan, Ladan; Faghankhani, Masoomeh; Javanbakht, Anna; Ahmadi, Seyed-Foad; Baradaran, Hamid Reza

    2011-01-01

    To compare PubMed Clinical Queries and UpToDate regarding the amount and speed of information retrieval and users' satisfaction. A cross-over randomized trial was conducted in February 2009 in Tehran University of Medical Sciences that included 44 year-one or two residents who participated in an information mastery workshop. A one-hour lecture on the principles of information mastery was organized followed by self learning slide shows before using each database. Subsequently, participants were randomly assigned to answer 2 clinical scenarios using either UpToDate or PubMed Clinical Queries then crossed to use the other database to answer 2 different clinical scenarios. The proportion of relevantly answered clinical scenarios, time to answer retrieval, and users' satisfaction were measured in each database. Based on intention-to-treat analysis, participants retrieved the answer of 67 (76%) questions using UpToDate and 38 (43%) questions using PubMed Clinical Queries (PUpToDate compared to 29 min (95% CI: 26 to 32) using PubMed Clinical Queries (PUpToDate and also overall satisfaction were higher among UpToDate users compared to PubMed Clinical Queries users (PUpToDate compared to Pubmed Clinical Queries can lead to not only a higher proportion of relevant answer retrieval within a shorter time, but also a higher users' satisfaction. So, addition of tutoring pre-appraised sources such as UpToDate to the information mastery curricula seems to be highly efficient.

  17. Dental Students’ Preference with regard to Tactile or Visual Determination of Injection Site for an Inferior Alveolar Nerve Block in Children: A Crossover Randomized Clinical Trial

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    Nahid Ramazani

    2016-08-01

    Full Text Available Objectives: Instruction of local anesthesia injection in an important part of dental education curricula. This study was performed to compare dental students’ preference with regard to tactile or visual determination of injection site for an inferior alveolar nerve block (IANB in children.Materials and Methods: This crossover randomized clinical trial was conducted on dental students of Zahedan Dental School who took the first practical course of pediatric dentistry in the first academic semester of 2013-14 (n=42. They were randomly divided into two groups. During the first phase, group I was instructed to find the needle insertion point for an IANB via tactile method and group II was instructed to do it visually. In the second phase, the groups received instructions for the alternate technique. Both instructions were done using live demonstrations by the same instructor and immediately after instruction the learners practiced an IANB using the taught method. A five-point Likert scale questionnaire was then filled out by the students. The preference score was determined by calculating the mean of item scores. Data were analyzed using Mann-Whitney U and Wilcoxon Singed Rank tests in SPSS 19 at P=0.05 level of significance.Results: Thirty-eight students completed the study. By using the visual method to perform an IANB, students gained a significantly higher mean preference score (P=0.020. There was a significant difference in the preference of male students (P=0.008.Conclusions: Instruction of IANB by visual identification of needle insertion point is more desirable by students. 

  18. Effects of a flaxseed-derived lignan supplement in type 2 diabetic patients: a randomized, double-blind, cross-over trial.

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    An Pan

    Full Text Available BACKGROUND: Flaxseed consumption has been shown to improve blood lipids in humans and flaxseed-derived lignan has been shown to enhance glycemic control in animals. The study aimed to investigate the effect of a flaxseed-derived lignan supplement on glycemic control, lipid profiles and insulin sensitivity in type 2 diabetic patients. METHODOLOGY/PRINCIPAL FINDINGS: This was a randomized, double-blind, placebo-controlled, cross-over trial and it was conducted between April and December 2006 in Shanghai, China. Seventy-three type 2 diabetic patients with mild hypercholesterolemia were enrolled into the study. Patients were randomized to supplementation with flaxseed-derived lignan capsules (360 mg lignan per day or placebo for 12 weeks, separated by an 8-week wash-out period. HbA1c, lipid profiles, insulin resistance index and inflammatory factors were measured. Sixty-eight completed the study and were included in the analyses. The lignan supplement significantly improved glycemic control as measured by HbA(1c (-0.10+/-0.65 % vs. 0.09+/-0.52 %, P = 0.001 compared to placebo; however, no significant changes were observed in fasting glucose and insulin concentrations, insulin resistance and blood lipid profiles. Urinary excretion of lignan metabolites (enterodiol and enterolactone was significantly higher after the lignan supplement intervention compared to baseline (14.2+/-18.1 vs. 1.2+/-2.4 microg/mL, P<0.001. Data also suggested minimal competition between lignan and isoflavones for bioavailability when measured by the excretion concentrations. CONCLUSIONS/SIGNIFICANCE: Daily lignan supplementation resulted in modest, yet statistically significant improvements in glycemic control in type 2 diabetic patients without apparently affecting fasting glucose, lipid profiles and insulin sensitivity. Further studies are needed to validate these findings and explore the efficacy of lignans on type 2 diabetes. TRIAL REGISTRATION: ClinicalTrials.gov NCT

  19. Residual gastric volume evaluation with ultrasonography after ingestion of carbohydrate- or carbohydrate plus glutamine-enriched beverages: a randomized, crossover clinical trial with healthy volunteers

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    Paulo Cesar GOMES

    Full Text Available ABSTRACT BACKGROUND Abbreviation of preoperative fasting to 2 hours with maltodextrin (CHO-enriched beverage is a safe procedure and may enhance postoperative recovery. Addition of glutamine (GLN to CHO beverages may include potential benefits to the metabolism. However, by adding a nitrogenous source to CHO beverages, gastric emptying may be delayed and increase the risk of bronchoaspiration during anesthesia. OBJECTIVE In this study of safety, we aimed at investigating the residual gastric volume (RGV 2 hours after the intake of either CHO beverage alone or CHO beverage combined with GLN. METHODS We performed a randomized, crossover clinical trial. We assessed RGV by means of abdominal ultrasonography (US in 20 healthy volunteers (10 males and 10 females after an overnight fast of 8 hours. Then, they were randomized to receive 600 mL (400 mL immediately after US followed by another 200 mL 2 hours afterwards of either CHO (12.5% maltodextrin or CHO-GLN (12.5% maltodextrin plus 15 g GLN. Two sequential US evaluations were done at 120 and 180 minutes after ingestion of the second dose. The interval of time between ingestion of the two types of beverages was 2 weeks. RESULTS The mean (SD RGV observed after 8 hours fasting (13.56±13.25 mL did not statistically differ (P>0.05 from the RGV observed after ingesting CHO beverage at both 120 (16.32±11.78 mL and 180 minutes (14.60±10.39 mL. The RGV obtained at 120 (15.63±18.83 mL and 180 (13.65±10.27 mL minutes after CHO-GLN beverage also was not significantly different from the fasting condition. CONCLUSION The RGV at 120 and 180 minutes after ingestion of CHO beverage combined with GLN is similar to that observed after an overnight fast.

  20. Residual gastric volume evaluation with ultrasonography after ingestion of carbohydrate- or carbohydrate plus glutamine-enriched beverages: a randomized, crossover clinical trial with healthy volunteers.

    Science.gov (United States)

    Gomes, Paulo Cesar; Caporossi, Cervantes; Aguilar-Nascimento, Jose Eduardo; Silva, Ageo Mario Candido da; Araujo, Viviane Maeve Tavares de

    2017-01-01

    - Abbreviation of preoperative fasting to 2 hours with maltodextrin (CHO)-enriched beverage is a safe procedure and may enhance postoperative recovery. Addition of glutamine (GLN) to CHO beverages may include potential benefits to the metabolism. However, by adding a nitrogenous source to CHO beverages, gastric emptying may be delayed and increase the risk of bronchoaspiration during anesthesia. - In this study of safety, we aimed at investigating the residual gastric volume (RGV) 2 hours after the intake of either CHO beverage alone or CHO beverage combined with GLN. - We performed a randomized, crossover clinical trial. We assessed RGV by means of abdominal ultrasonography (US) in 20 healthy volunteers (10 males and 10 females) after an overnight fast of 8 hours. Then, they were randomized to receive 600 mL (400 mL immediately after US followed by another 200 mL 2 hours afterwards) of either CHO (12.5% maltodextrin) or CHO-GLN (12.5% maltodextrin plus 15 g GLN). Two sequential US evaluations were done at 120 and 180 minutes after ingestion of the second dose. The interval of time between ingestion of the two types of beverages was 2 weeks. - The mean (SD) RGV observed after 8 hours fasting (13.56±13.25 mL) did not statistically differ (P>0.05) from the RGV observed after ingesting CHO beverage at both 120 (16.32±11.78 mL) and 180 minutes (14.60±10.39 mL). The RGV obtained at 120 (15.63±18.83 mL) and 180 (13.65±10.27 mL) minutes after CHO-GLN beverage also was not significantly different from the fasting condition. - The RGV at 120 and 180 minutes after ingestion of CHO beverage combined with GLN is similar to that observed after an overnight fast.

  1. Comparison of Low-Dose Higher-Relaxivity and Standard-Dose Lower-Relaxivity Contrast Media for Delayed-Enhancement MRI: A Blinded Randomized Crossover Study.

    Science.gov (United States)

    Cheong, Benjamin Y C; Duran, Cihan; Preventza, Ourania A; Muthupillai, Raja

    2015-09-01

    The gadolinium-based MRI contrast agent gadobenate dimeglumine has nearly twice the MR relaxivity of gadopentetate dimeglumine at 1.5 T. The purpose of this study was to determine whether a lower dose (0.1 mmol/kg) of gadobenate dimeglumine can be used to obtain delayed-enhancement MR images comparable to those obtained with a standard dose (0.2 mmol/kg) of gadopentetate dimeglumine. In this blinded randomized crossover study, 20 patients with known myocardial infarction underwent two separate delayed-enhancement MRI examinations after receiving 0.1 mmol/kg gadobenate dimeglumine and 0.2 mmol/kg gadopentetate dimeglumine (random administration). The conspicuity of lesion enhancement 5, 10, and 20 minutes after contrast administration was quantified as relative enhancement ratio (RER). With either gadolinium-based contrast agent, damaged myocardium had higher signal intensity than normal remote myocardium (RER > 4) on delayed-enhancement MR images, and the blood RER declined over time after contrast administration. The blood RER was not significantly higher for gadobenate dimeglumine than for gadopentetate dimeglumine at 5 and 10 minutes. Nevertheless, there was a larger reduction in blood RER for gadobenate dimeglumine than for gadopentetate dimeglumine between 5 and 10 minutes and between 10 and 20 minutes. The volumes of enhancement were similar for gadobenate dimeglumine (13.6 ± 8.8 cm(3)) and gadopentetate dimeglumine (13.5 ± 8.9 cm(3)) (p = 0.98). The mean difference in Bland-Altman analysis for delayed-enhancement volume between the agents was 0.1 cm(3). Qualitatively and quantitatively, delayed-enhancement MR images of ischemic myocardium obtained with 0.1 mmol/kg gadobenate dimeglumine are comparable to those obtained with 0.2 mmol/kg gadopentetate dimeglumine 5, 10, and 20 minutes after contrast administration.

  2. 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.

  3. Gesture-Controlled Image Management for Operating Room: A Randomized Crossover Study to Compare Interaction Using Gestures, Mouse, and Third Person Relaying.

    Science.gov (United States)

    Wipfli, Rolf; Dubois-Ferrière, Victor; Budry, Sylvain; Hoffmeyer, Pierre; Lovis, Christian

    2016-01-01

    In this work, we aim at comparing formally three different interaction modes for image manipulation that are usable in a surgery setting: 1) A gesture-controlled approach using Kinect ®; 2) oral instructions to a third part dedicated to manipulate the images; and 3) direct manipulation using a mouse. Each participant used the radiology image viewer Weasis with the three interaction modes. In a crossover randomized controlled trial participants were attributed block wise to six experimental groups. For each group, the order for testing the three modes was randomly assigned. Nine standardized scenarios were used. 30 physicians and senior medical students participated in the experiment. Efficiency, measured as time used to pass the scenario, was best when using the mouse (M = 109.10s, SD = 25.96), followed by gesture-controlled (M = 214.97s, SD = 46.29) and oral instructions (M = 246.33s, SD = 76.50). Satisfaction, measured by a questionnaire, was rated highest in the condition mouse (M = 6.63, SD = 0.56), followed by gesture-controlled (M = 5.77, SD = 0.93) and oral instructions (M = 4.40, SD = 1.71). Differences in efficiency and satisfaction rating were significant. No significant difference in effectiveness, measured with error rates, was found. The study shows with formal evaluation that the use of gestures is advantageous over instructions to a third person. In particular, the use of gestures is more efficient than verbalizing instructions. The given gestures could be learned easily and reliability of the tested gesture-control system is good. Under the premise that mouse cannot be used directly during surgery, gesture-controlled approaches demonstrate to be superior to oral instructions for image manipulation.

  4. To compare PubMed Clinical Queries and UpToDate in teaching information mastery to clinical residents: a crossover randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Ladan Sayyah Ensan

    Full Text Available PURPOSE: To compare PubMed Clinical Queries and UpToDate regarding the amount and speed of information retrieval and users' satisfaction. METHOD: A cross-over randomized trial was conducted in February 2009 in Tehran University of Medical Sciences that included 44 year-one or two residents who participated in an information mastery workshop. A one-hour lecture on the principles of information mastery was organized followed by self learning slide shows before using each database. Subsequently, participants were randomly assigned to answer 2 clinical scenarios using either UpToDate or PubMed Clinical Queries then crossed to use the other database to answer 2 different clinical scenarios. The proportion of relevantly answered clinical scenarios, time to answer retrieval, and users' satisfaction were measured in each database. RESULTS: Based on intention-to-treat analysis, participants retrieved the answer of 67 (76% questions using UpToDate and 38 (43% questions using PubMed Clinical Queries (P<0.001. The median time to answer retrieval was 17 min (95% CI: 16 to 18 using UpToDate compared to 29 min (95% CI: 26 to 32 using PubMed Clinical Queries (P<0.001. The satisfaction with the accuracy of retrieved answers, interaction with UpToDate and also overall satisfaction were higher among UpToDate users compared to PubMed Clinical Queries users (P<0.001. CONCLUSIONS: For first time users, using UpToDate compared to Pubmed Clinical Queries can lead to not only a higher proportion of relevant answer retrieval within a shorter time, but also a higher users' satisfaction. So, addition of tutoring pre-appraised sources such as UpToDate to the information mastery curricula seems to be highly efficient.

  5. The effects of soybean-flour-enriched bread intake on inflammatory markers among type 2 diabetic women: a cross-over randomized controlled clinical trial

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    Asma Salari Moghadam

    2017-05-01

    Full Text Available Introduction: Although soy-based foods have been reported to affect serum levels of inflammatory biomarkers, there was no study examining the effects of soybean flour-enriched bread in diabetic patients. The aim of this study was to determine the effects of consumption of soybean flour-enriched bread on inflammatory markers in type 2 diabetic women. Methods: This randomized, cross-over, controlled clinical trial recruited 30 type 2 diabetic women. After a 2-week run-in period, participants were randomly assigned to either intervention (soy bread or control groups (habitual diet. Participants in the intervention group were asked to consume 120 g of soybean flour-enriched bread instead of the same amount of usual bread intake or other cereals. Participants in the control group were asked to remain on the habitual diet. After a four-week washout period, the participants were crossed over for another six weeks. Results: Mean (±SD age, weight and BMI of the subjects was 45.7±3.8 years, 73.8±10.7 and 29.5±3.9 kg/m2, respectively. We found no significant effect of soybean flour-enriched bread on high sensitive C-reactive protein (change difference: -0.04, P=0.6, Tumor Necrosis Factor-alpha (change difference: -14.2, P=0.27, interleukin 6 (change difference: -0.06, P=0.15 and Soluble Vascular Cell Adhesion Molecule-1 among women in the intervention group compared with the control group. No significant effects were observed in serum levels of sVCAM1 after consumption of soybean flour-enriched bread. Conclusion: Soybean flour-enriched bread consumption had no significant effects on inflammatory markers.

  6. Cardiorespiratory responses of air filtration: A randomized crossover intervention trial in seniors living in Beijing: Beijing Indoor Air Purifier StudY, BIAPSY.

    Science.gov (United States)

    Shao, Danqing; Du, Yipeng; Liu, Shuo; Brunekreef, Bert; Meliefste, Kees; Zhao, Qian; Chen, Jie; Song, Xiaoming; Wang, Meng; Wang, Juan; Xu, Hongbing; Wu, Rongshan; Wang, Tong; Feng, Baihuan; Lung, Candice Shih-Chun; Wang, Xian; He, Bei; Huang, Wei

    2017-12-15

    In this Beijing Indoor Air Purifier StudY (BIAPSY), we conducted a randomized crossover intervention trial in a panel of 35 non-smoking senior participants with free-living, with and without chronic obstructive pulmonary disease (COPD). Portable air filtration units were randomly allocated to active-(filter in) for 2weeks and sham-mode (filter out) for 2weeks in the households. We examined the differences in indoor air pollutant concentrations in 20 study homes and a suite of cardio-respiratory biomarker levels in study participants between filtration modes, with and without adjustment for potential confounders. Following active filtration, we observed significant reductions from 60±45 to 24±15μg/m 3 in ten-day averages of indoor PM 2.5 and reductions from 3.87±1.65 to 1.81±1.19m -1 .10 -5 in ten-day averages of indoor BC, compared to sham-mode filtration. The major components of indoor PM 2.5 , including water soluble organics, NO 3 - , SO 4 2- , Zn 2+ , Pb 2+ and K + , were also reduced significantly by 42% to 63%. However, following active filtration, we only observed significant reductions on systemic inflammation measured as of IL-8 at 58.59% (95% CI: -76.31, -27.64) in the total group of participants and 70.04% (95% CI: -83.05, -47.05) in the subset of COPD patients, with adjustments. We were not able to detect improvements on lung function, blood pressure, and heart rate variability, following short-term intervention of two-week active air filtration. In conclusion, our results showed that indoor air filtration produced clear improvement on indoor air quality, but no demonstrable changes in the cardio-respiratory outcomes of study interest observed in the seniors living with real-world air pollution exposures. Copyright © 2017 Elsevier B.V. All rights reserved.

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

    Science.gov (United States)

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

    2013-01-01

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

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

    Science.gov (United States)

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

    2012-07-01

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

  9. The effect of elastic therapeutic taping on back extensor muscle endurance in patients with low back pain: a randomized, controlled, crossover trial.

    Science.gov (United States)

    Hagen, Lindsey; Hebert, Jeffrey J; Dekanich, Joel; Koppenhaver, Shane

    2015-03-01

    Randomized, controlled, crossover trial. To examine the effects of elastic therapeutic taping (ETT) applied to the lumbar paraspinal region on back muscle endurance (BME) compared to no tape or a rigid therapeutic taping (RTT) procedure in individuals with nonspecific low back pain. Elastic therapeutic taping is an increasingly popular intervention for clinicians who treat patients with low back pain. However, no studies have investigated the effect of ETT on back extensor muscle performance in a symptomatic population. We measured BME in 16 patients (mean ± SD age, 44.8 ± 10.4 years; 44% female) with nonspecific low back pain. Back muscle endurance was measured using the Biering-Sørensen test under 3 different conditions: ETT, no tape, and RTT. For the ETT condition, the tape was applied over the paraspinal muscles according to the Kinesio Tex taping protocol. The RTT condition consisted of the same tape configuration but using nonelastic athletic tape. All participants received each testing condition in random order, with 1 to 3 days between each condition. Differences in BME between the 3 testing conditions were explored with repeated-measures analyses of variance. There were no differences in BME between ETT and RTT, or between the RTT and no-tape conditions. The difference in BME between the ETT and no-tape conditions was statistically significant (mean difference, 20.7 seconds; 95% confidence interval: 6.8, 34.5; P = .006) but within the threshold of measurement error. Back muscle endurance was higher with ETT applied over the paraspinal musculature when compared to a no-tape condition. However, the magnitude of difference did not exceed measurement error. There was no difference in BME when using elastic or rigid therapeutic tape.

  10. Immediate Changes in Resting and Contracted Thickness of Transversus Abdominis After Dry Needling of Lumbar Multifidus in Healthy Participants: A Randomized Controlled Crossover Trial.

    Science.gov (United States)

    Puentedura, Emilio J; Buckingham, Sarah J; Morton, Daniella; Montoya, Crystal; Fernandez de Las Penas, Cesar

    2017-10-01

    The purpose of this study was to investigate changes in resting and/or contraction thickness of the transversus abdominis (TrA) muscle after dry needling (DN) of the lumbar multifidus (LM) in asymptomatic participants. A randomized controlled laboratory trial with crossover design was performed. Forty-seven healthy individuals who had not experienced low back pain in the previous 6 months were randomly assigned to receive DN to the LM or a sham-DN intervention. Participants received both interventions separated at least 7 days apart. They were instructed on how to perform a concentric contraction of TrA. Resting and contraction thicknesses of the TrA were obtained through real-time ultrasound measurements before and immediately after each intervention by an assessor blinded to the intervention received. Data from 4 individuals had to be excluded because of poor image quality. Two-way analysis of variance revealed a significant contraction with treatment interaction (F[1,42] = 11.489; P = .002). Simple main effects using paired-samples t tests and a Bonferroni post hoc analysis revealed differences in contracted states of the TrA for DN vs sham-DN (P = .009) and between contracted and resting states for the DN group (P = .001): after DN, TrA thickness at rest exhibited a mean decrease of 0.03 cm and a mean increase of 0.05 cm during contraction. This study suggests that application of DN to LM was accompanied by a decreased resting thickness and an increased contraction thickness of the TrA in asymptomatic participants. Copyright © 2017. Published by Elsevier Inc.

  11. Effects of a Gentle, Self-Administered Stimulation of Perineal Skin for Nocturia in Elderly Women: A Randomized, Placebo-Controlled, Double-Blind Crossover Trial.

    Directory of Open Access Journals (Sweden)

    Kaori Iimura

    Full Text Available Somatic afferent nerve stimuli are used for treating an overactive bladder (OAB, a major cause of nocturia in the elderly. Clinical evidence for this treatment is insufficient because of the lack of appropriate control stimuli. Recent studies on anesthetized animals show that gentle stimuli applied to perineal skin with a roller could inhibit micturition contractions depending on the roller's surface material. We examined the efficacy of gentle skin stimuli for treating nocturia.The study was a cross-over, placebo-controlled, double-blind randomized clinical study using two rollers with different effects on micturition contractions. Participants were elderly women (79-89 years with nocturia. Active (soft elastomer roller or placebo (hard polystyrene roller stimuli were applied to perineal skin by participants for 1 min at bedtime. A 3-day baseline assessment period was followed by 3-day stimulation and 4-day resting periods, after which the participants were subjected to other stimuli for another 3 days. The primary outcome was change in the frequency of nighttime urination, for which charts were maintained during each 3-day period.Twenty-four participants were randomized, of which 22 completed all study protocols. One participant discontinued treatment because of an adverse event (abdominal discomfort. In participants with OAB (n = 9, change from baseline in the mean frequency of urination per night during the active stimuli period (mean ± standard deviation, -0.74 ± 0.7 times was significantly greater than that during placebo stimuli periods (-0.15 ± 0.8 times [p < 0.05]. In contrast, this difference was not observed in participants without OAB (n = 13.These results suggest that gentle perineal stimulation with an elastomer roller is effective for treating OAB-associated nocturia in elderly women. Here the limitation was a study period too short to assess changes in the quality of sleep and life.UMIN Clinical Trial Registry (CTR UMIN

  12. 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.

  13. The effect of music on biochemical markers and self-perceived stress among first-line nurses: a randomized controlled crossover trial.

    Science.gov (United States)

    Lai, Hui-Ling; Li, Yin-Ming

    2011-11-01

    The aim of this study was to examine the effects of music on stress indices and to examine the association between music preference and stress. Although clinical studies have demonstrated the effectiveness of music on stress, study results have been inconsistent. At the time of writing, no known publications had investigated the effects of preferred music on workers in high-stress professions such as nursing. Using a randomized crossover controlled trial, 54 nurses were randomly assigned to a music/chair rest sequence or chair rest/music sequence during the period February to June 2006. Each intervention lasted for 30 minutes. Participants in the music condition listened to self-selected soothing music using headphones for 30 minutes. In the chair rest condition, participants sat quietly for 30 minutes. Serial measurements of participants' heart rate, mean arterial pressure, finger temperature and cortisol levels were taken with a BP monitor and chemillumincent immunoassay every 15 minutes throughout the procedure. Compared with chair rest, participants had a lower perceived stress level, cortisol, heart rate, mean arterial pressure and higher finger temperature while listening to music (P test heart rate, cortisol levels, finger temperature and mean arterial pressure (P Music preference scores ranged between 7 and 10, with a mean score of 8·81 (sd = 1·05), and was significantly associated with mean arterial pressure, cortisol levels, self-perceived stress and finger temperature. The findings provided evidence for nurses to use soothing music as a research-based nursing intervention for stress reduction. © 2011 The Authors. Journal of Advanced Nursing © 2011 Blackwell Publishing Ltd.

  14. A randomized crossover clinical study showing that methylphenidate-SODAS improves attention-deficit/hyperactivity disorder symptoms in adolescents with substance use disorder.

    Science.gov (United States)

    Szobot, C M; Rohde, L A; Katz, B; Ruaro, P; Schaefer, T; Walcher, M; Bukstein, O; Pechansky, F

    2008-03-01

    Our objective was to evaluate the effectiveness of a long-acting formulation of methylphenidate (MPH-SODAS) on attention-deficit/hyperactivity disorder (ADHD) symptoms in an outpatient sample of adolescents with ADHD and substance use disorders (SUD). Secondary goals were to evaluate the tolerability and impact on drug use of MPH-SODAS. This was a 6-week, single-blind, placebo-controlled crossover study assessing efficacy of escalated doses of MPH-SODAS on ADHD symptoms in 16 adolescents with ADHD/SUD. Participants were randomly allocated to either group A (weeks 1-3 on MPH-SODAS, weeks 4-6 on placebo) or group B (reverse order). The primary outcome measures were the Swanson, Nolan and Pelham Scale, version IV (SNAP-IV) and the Clinical Global Impression Scale (CGI). We also evaluated the adverse effects of MPH-SODAS using the Barkley Side Effect Rating Scale and subject reports of drug use during the study. The sample consisted of marijuana (N = 16; 100%) and cocaine users (N = 7; 43.8%). Subjects had a significantly greater reduction in SNAP-IV and CGI scores (P treatment compared to placebo. No significant effects for period or sequence were found in analyses with the SNAP-IV and CGI scales. There was no significant effect on drug use. MPH-SODAS was well tolerated but was associated with more severe appetite reduction than placebo (P ADHD symptoms in a non-abstinent outpatient sample of adolescents with comorbid SUD. Randomized clinical trials, with larger samples and SUD intervention, are recommended.

  15. Safety and efficacy of a fully closed-loop control ventilation (IntelliVent-ASV®) in sedated ICU patients with acute respiratory failure: a prospective randomized crossover study.

    Science.gov (United States)

    Arnal, Jean-Michel; Wysocki, Marc; Novotni, Dominik; Demory, Didier; Lopez, Ricardo; Donati, Stéphane; Granier, Isabelle; Corno, Gaëlle; Durand-Gasselin, Jacques

    2012-05-01

    IntelliVent-ASV(®) is a development of adaptive support ventilation (ASV) that automatically adjusts ventilation and oxygenation parameters. This study assessed the safety and efficacy of IntelliVent-ASV(®) in sedated intensive care unit (ICU) patients with acute respiratory failure. This prospective randomized crossover comparative study was conducted in a 12-bed ICU in a general hospital. Two periods of 2 h of ventilation in randomly applied ASV or IntelliVent-ASV(®) were compared in 50 sedated, passively ventilated patients. Tidal volume (V(T)), respiratory rate (RR), inspiratory pressure (P(INSP)), SpO(2) and E(T)CO(2) were continuously monitored and recorded breath by breath. Mean values over the 2-h period were calculated. Respiratory mechanics, plateau pressure (P(PLAT)) and blood gas exchanges were measured at the end of each period. There was no safety issue requiring premature interruption of IntelliVent-ASV(®). Minute ventilation (MV) and V(T) decreased from 7.6 (6.5-9.5) to 6.8 (6.0-8.0) L/min (p mechanics, pH, PaO(2) and PaO(2)/FiO(2) ratio were not different but PaCO(2) was slightly higher during IntelliVent-ASV(®) as compared to ASV. In passive patients with acute respiratory failure, IntelliVent-ASV(®) was safe and able to ventilate patients with less pressure, volume and FiO(2) while producing the same results in terms of oxygenation.

  16. Early functional postoperative therapy of distal radius fracture with a dynamic orthosis: results of a prospective randomized cross-over comparative study.

    Science.gov (United States)

    Stuby, Fabian M; Döbele, Stefan; Schäffer, Susanne-Dorothea; Mueller, Simon; Ateschrang, Atesch; Baumann, Matthias; Zieker, Derek

    2015-01-01

    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.

  17. Effects of Transcranial Direct Current Stimulation, Transcranial Pulsed Current Stimulation, and Their Combination on Brain Oscillations in Patients with Chronic Visceral Pain: A Pilot Crossover Randomized Controlled Study

    Directory of Open Access Journals (Sweden)

    Aurore Thibaut

    2017-11-01

    Full Text Available ObjectiveChronic visceral pain (CVP syndromes are persistently painful disorders with a remarkable lack of effective treatment options. This study aimed at evaluating the effects of different neuromodulation techniques in patients with CVP on cortical activity, through electreocephalography (EEG and on pain perception, through clinical tests.DesignA pilot crossover randomized controlled study.SettingsOut-patient.SubjectsAdults with CVP (>3 months.MethodsParticipants received four interventions in a randomized order: (1 transcranial pulsed current stimulation (tPCS and active transcranial direct current stimulation (tDCS combined, (2 tPCS alone, (3 tDCS alone, and (4 sham condition. Resting state quantitative electroencephalography (qEEG and pain assessments were performed before and after each intervention. Results were compared with a cohort of 47 healthy controls.ResultsWe enrolled six patients with CVP for a total of 21 visits completed. Compared with healthy participants, patients with CVP showed altered cortical activity characterized by increased power in theta, alpha and beta bands, and a significant reduction in the alpha/beta ratio. Regarding tES, the combination of tDCS with tPCS had no effect on power in any of the bandwidths, nor brain regions. Comparing tPCS with tDCS alone, we found that tPCS induced higher increase in power within the theta and alpha bandwidths.ConclusionThis study confirms that patients with CVP present abnormal EEG-indexed cortical activity compared with healthy controls. Moreover, we showed that combining two types of neurostimulation techniques had no effect, whereas the two interventions, when applied individually, have different neural signatures.

  18. Switching patients with acromegaly from octreotide to pasireotide improves biochemical control: crossover extension to a randomized, double-blind, Phase III study.

    Science.gov (United States)

    Bronstein, Marcello D; Fleseriu, Maria; Neggers, Sebastian; Colao, Annamaria; Sheppard, Michael; Gu, Feng; Shen, Chiung-Chyi; Gadelha, Mônica; Farrall, Andrew J; Hermosillo Reséndiz, Karina; Ruffin, Matthieu; Chen, YinMiao; Freda, Pamela

    2016-04-02

    Many patients with acromegaly do not achieve biochemical control with first-generation somatostatin analogues. A large, multicenter, randomized, Phase III core study demonstrated that pasireotide LAR had significantly superior efficacy over octreotide LAR. This analysis explores the efficacy and safety of switching therapeutic arms in inadequately controlled patients during a 12-month crossover extension. Patients with inadequate biochemical control (GH ≥2.5 μg/L and/or IGF-1 > ULN) at end of core study (month 12) were eligible to switch to pasireotide LAR 40 mg/28 days (n = 81) or octreotide LAR 20 mg/28 days (n = 38). One dose escalation to pasireotide LAR 60 mg/28 days or octreotide LAR 30 mg/28 days was permitted, but not mandatory, at month 17 or 20. Twelve months after crossover, 17.3 % of pasireotide LAR and 0 % of octreotide LAR patients achieved GH <2.5 μg/L and normal IGF-1 (main outcome measure); 27.2 and 5.3 % of pasireotide LAR and octreotide LAR patients achieved normal IGF-1, respectively; 44.4 and 23.7 % of pasireotide LAR and octreotide LAR patients achieved GH <2.5 μg/L, respectively. Mean (±SD) tumor volume further decreased from the end of the core study by 25 % (±25) and 18 % (±28); 54.3 % of pasireotide LAR and 42.3 % of octreotide LAR patients achieved significant (≥20 %) tumor volume reduction during the extension. The safety profile of pasireotide LAR was similar to that of octreotide LAR, with the exception of the frequency and degree of hyperglycemia-related adverse events. Pasireotide LAR is a promising treatment option for patients with acromegaly inadequately controlled with the first-generation somatostatin analogue octreotide LAR. clinicaltrials.gov, NCT00600886 . Registered 14 January 2008.

  19. Concord grape juice, cognitive function, and driving performance: a 12-wk, placebo-controlled, randomized crossover trial in mothers of preteen children.

    Science.gov (United States)

    Lamport, Daniel J; Lawton, Clare L; Merat, Natasha; Jamson, Hamish; Myrissa, Kyriaki; Hofman, Denise; Chadwick, Helen K; Quadt, Frits; Wightman, JoLynne D; Dye, Louise

    2016-03-01

    Daily consumption of Concord grape juice (CGJ) over 3-4 mo has been shown to improve memory function in adults with mild cognitive impairment and reduce blood pressure in hypertensive adults. These benefits likely result from the high concentration of polyphenols in CGJ. Increased stress can impair cognitive function and elevate blood pressure. Thus, we examined the potential beneficial effect of CGJ in individuals with somewhat stressful and demanding lifestyles. We sought to examine the effects of the daily consumption of CGJ for 12 wk on cognitive function, driving performance, and blood pressure in healthy, middle-aged working mothers. Twenty-five healthy mothers (aged 40-50 y) of preteen children who were employed for ≥30 h/wk consumed 12 ounces (355 mL) of either CGJ (containing 777 mg total polyphenols) or an energy-, taste-, and appearance-matched placebo daily for 12 wk according to a randomized crossover design with a 4-wk washout. Verbal and spatial memory, executive function, attention, blood pressure, and mood were assessed at baseline and at 6 and 12 wk. Immediately after the cognitive battery, a subsample of 17 women completed a driving performance assessment at the University of Leeds Driving Simulator. The 25-min driving task required participants to match the speed and direction of a lead vehicle. Significant improvements in immediate spatial memory and driving performance were observed after CGJ relative to placebo. There was evidence of an enduring effect of CGJ such that participants who received CGJ in arm 1 maintained better performance in the placebo arm. Cognitive benefits associated with the long-term consumption of flavonoid-rich grape juice are not exclusive to adults with mild cognitive impairment. Moreover, these cognitive benefits are apparent in complex everyday tasks such as driving. Effects may persist beyond the cessation of flavonoid consumption, and future studies should carefully consider the length of washout within

  20. The randomized crossover comparison of airway sealing with the laryngeal mask airway Supreme(™) at three different intracuff pressures in children.

    Science.gov (United States)

    Choi, Kwan-Woong; Lee, Jeong-Rim; Oh, Jung-Tak; Kim, Dong Wook; Kim, Min-Soo

    2014-10-01

    An intracuff pressure of 80 cm H2 O in the adult-sized laryngeal mask airway Supreme has been recommended to obtain a higher oropharyngeal leak pressure (OLP). However, the intracuff pressure for the higher OLP in the pediatric laryngeal mask airway Supreme could be different from that in the adult-sized laryngeal mask airway Supreme. Thus, we measured and compared OLP at three intracuff pressures of 40, 60, and 80 cm H2 O in the pediatric laryngeal mask airway Supreme. This study was designed as a randomized crossover study and enrolled 36 children, aged 0-108 months and 5-30 kg in weight. After insertion of the laryngeal mask airway Supreme, oropharyngeal leak pressure (OLP) was measured at intracuff pressures of 40, 60, and 80 cm H2 O according to one of six sequences produced on the basis of 3 × 6 Williams crossover design. During the intraoperative period, the laryngeal mask airway Supreme was maintained using the last intracuff pressure of the allocated sequence. The intraoperative and postoperative complications were compared among three maintenance intracuff pressures. OLP at the intracuff pressure of 60 cm H2 O was significantly higher than that of 40 cm H2 O (17.9 ± 3.9 vs 16.9 ± 4.2 cm H2 O, P = 0.004) and was comparable with that of 80 cm H2 O (17.9 ± 3.9 vs 17.8 ± 4.6 cm H2 O, P = 0.938). There were no significant differences of intraoperative and postoperative complications among the three maintenance intracuff pressures. Our results suggest that the use of an intracuff pressure of 60 cm H2 O in pediatric laryngeal mask airway Supreme provides a higher OLP compared with 40 cm H2 O. © 2014 John Wiley & Sons Ltd.

  1. Multicenter, double-blind, randomized, intraindividual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine for Breast MR imaging (DETECT Trial).

    Science.gov (United States)

    Martincich, Laura; Faivre-Pierret, Matthieu; Zechmann, Christian M; Corcione, Stefano; van den Bosch, Harrie C M; Peng, Wei-Jun; Petrillo, Antonella; Siegmann, Katja C; Heverhagen, Johannes T; Panizza, Pietro; Gehl, Hans-Björn; Diekmann, Felix; Pediconi, Federica; Ma, Lin; Gilbert, Fiona J; Sardanelli, Francesco; Belli, Paolo; Salvatore, Marco; Kreitner, Karl-Friedrich; Weiss, Claudia M; Zuiani, Chiara

    2011-02-01

    To intraindividually compare 0.1 mmol/kg doses of gadobenate dimeglumine and gadopentetate dimeglumine for contrast material-enhanced breast magnetic resonance (MR) imaging by using a prospective, multicenter double-blind, randomized protocol. Institutional review board approval and patient informed consent were obtained. One hundred sixty-two women (mean age, 52.8 years ± 12.3 [standard deviation]) enrolled at 17 sites in Europe and China between July 2007 and May 2009 underwent at least one breast MR imaging examination at 1.5 T by using three-dimensional spoiled gradient-echo sequences. Of these, 151 women received both contrast agents in randomized order in otherwise identical examinations separated by more than 2 but less than 7 days. Images, acquired at 2-minute or shorter intervals after contrast agent injection, were evaluated independently by three blinded radiologists unaffiliated with enrollment centers. Histopathologic confirmation was available for all malignant lesions (n = 144), while benign lesions were confirmed either by using histopathologic examination (n = 52) or by at least 12-month diagnostic follow-up (n = 20) with mammography and/or ultrasonography. Determinations of malignant lesion detection rates and diagnostic performance (sensitivity, specificity, accuracy, positive predictive value [PPV], and negative predictive value [NPV]) were performed and compared (McNemar and Wald tests). A full safety assessment was performed. Significant superiority for gadobenate dimeglumine was noted by readers 1, 2, and 3 for malignant lesion detection rate (91.7%, 93.1%, 94.4% vs 79.9%, 80.6%, 83.3%, respectively; P ≤ .0003). Readers 1, 2, and 3 reported significantly superior diagnostic performance (sensitivity, specificity, and accuracy) for breast cancer detection with gadobenate dimeglumine (91.1%, 94.5%, 95.2% vs 81.2%, 82.6%, 84.6%; 99.0%, 98.2%, 96.9% vs 97.8%, 96.9%, 93.8%; 98.2%, 97.8%, 96.7% vs 96.1%, 95.4%, 92.8%, respectively; P ≤ .0094

  2. Development and application of culturally appropriate decision aids for smoking cessation in Korea: a pragmatic clustered randomization crossover trial

    Directory of Open Access Journals (Sweden)

    Lee JE

    2016-09-01

    Full Text Available Ji Eun Lee,1 Dong Wook Shin,1–3 Beomseok Suh,1 Sohyun Chun,4 You-Seon Nam,3 Belong Cho1,2 1Department of Family Medicine, Health Promotion Center, 2Laboratory of Health Promotion and Health Behavior, Biomedical Research Institute, Seoul National University Hospital, 3JW Lee Center for Global Medicine, Seoul National University College of Medicine, 4International Health Services, Samsung Medical Center, Sungkyunkwan University College of Medicine, Seoul, Republic of Korea Introduction: In Asian countries, reluctance to seek pharmacological intervention is a major barrier for smoking cessation. Culturally appropriate decision aids are expected to help people in the decision making for the use of smoking cessation medication. Objective: The aim of this study was to develop a culturally tailored decision aid for smoking cessation and evaluate its effect on the use of smoking cessation medication. Patients and methods: A 7-minute video on smoking cessation information and options was developed. Physicians were randomized into intervention and control groups. The decision aid was provided to patients in the intervention group, and they watched it, while those in the control group were provided usual medical care for smoking cessation. The primary outcome was the proportion of smokers who were prescribed smoking cessation medication within 1 month after consultation. The secondary outcomes were abstinence rate and use of smoking cessation medication within 6 months. A logistic regression analysis was used to assess the effect of the decision aid on the outcomes. Results: In total, 414 current smokers (intervention group: 195; control group: 219 were enrolled. The mean age of the participants was 48.2 years, and 381 subjects (92% were males. In total, 11.8% of the participants in the intervention group and 10.5% in the control group were prescribed smoking cessation medications within 1 month. The odds ratio was 1.02 (95% CI: 0.40–2.63 after

  3. Simplicity transformations for three-way arrays with symmetric slices, and applications to Tucker-3 models with sparse core arrays

    NARCIS (Netherlands)

    Tendeiro, Jorge N.; Ten Berge, Jos M.F.; Kiers, Henk A.L.

    2009-01-01

    Tucker three-way PCA and Candecomp/Parafac are two well-known methods of generalizing principal component analysis to three way data. Candecomp/Parafac yields component matrices A (e.g., for subjects or objects), B (e.g., for variables) and C (e.g., for occasions) that are typically unique up to

  4. Finding the limit of diverging components in three-way Candecomp/Parafac : A demonstration of its practical merits

    NARCIS (Netherlands)

    Stegeman, Alwin

    Three-way Candecomp/Parafac (CP) is a three-way generalization of principal component analysis (PCA) for matrices. Contrary to PCA, a CP decomposition is rotationally unique under mild conditions. However, a CP analysis may be hampered by the non-existence of a best-fitting CP decomposition with R≤2

  5. Evaluation of concentrations of botulinum toxin A for the treatment of hemifacial spasm: a randomized double-blind crossover trial.

    Science.gov (United States)

    Li, Y J; Huang, Y; Ding, Q; Gu, Z H; Pan, X L

    2015-02-06

    The aim of our study was to evaluate the efficacy and safety of two concentrations of botulinum toxin A (BTX-A) for the treatment of hemifacial spasm. We randomly divided 20 patients with hemifacial spasm into high- and low-concentration groups; they were administered 50 and 25 U/mL BTX-A injection, respectively. Further, we compared the curative effects and the occurrence of adverse reactions in the two groups. Our results showed that both the concentrations of BTX-A were effective and no significant difference was observed in the onset time and therapeutic efficacy between the two groups; however, the duration of efficacy was longer in the high-concentration group than in the low-concentration group. Patients in both groups had no allergic reactions and systemic toxic reactions, but those in the high-concentration group had more serious adverse reactions and they lasted for longer durations. The adverse reactions in the two groups were not specifically treated, and they resolved in a relatively short time. In conclusion, local injection of BTX-A was effective in treating hemifacial spasm and each concentration of BTX-A had advantages and disadvantages, which indicated that the concentration of BTX-A can be selected according to the clinical characteristics and willingness of the patients.

  6. Searching for answers to clinical questions using google versus evidence-based summary resources: a randomized controlled crossover study.

    Science.gov (United States)

    Kim, Sarang; Noveck, Helaine; Galt, James; Hogshire, Lauren; Willett, Laura; O'Rourke, Kerry

    2014-06-01

    To compare the speed and accuracy of answering clinical questions using Google versus summary resources. In 2011 and 2012, 48 internal medicine interns from two classes at Rutgers University Robert Wood Johnson Medical School, who had been trained to use three evidence-based summary resources, performed four-minute computer searches to answer 10 clinical questions. Half were randomized to initiate searches for answers to questions 1 to 5 using Google; the other half initiated searches using a summary resource. They then crossed over and used the other resource for questions 6 to 10. They documented the time spent searching and the resource where the answer was found. Time to correct response and percentage of correct responses were compared between groups using t test and general estimating equations. Of 480 questions administered, interns found answers for 393 (82%). Interns initiating searches in Google used a wider variety of resources than those starting with summary resources. No significant difference was found in mean time to correct response (138.5 seconds for Google versus 136.1 seconds for summary resource; P = .72). Mean correct response rate was 58.4% for Google versus 61.5% for summary resource (mean difference -3.1%; 95% CI -10.3% to 4.2%; P = .40). The authors found no significant differences in speed or accuracy between searches initiated using Google versus summary resources. Although summary resources are considered to provide the highest quality of evidence, improvements to allow for better speed and accuracy are needed.

  7. Effects of chocolate milk consumption on markers of muscle recovery following soccer training: a randomized cross-over study

    Directory of Open Access Journals (Sweden)

    Womack Christopher J

    2010-05-01

    Full Text Available Abstract Background The efficacy of chocolate milk (CM as a recovery beverage following a period of increased training duration (ITD was studied in intercollegiate soccer players. Methods 13 subjects completed one week of normal 'baseline' training followed by four days of ITD. After each day of ITD, subjects received either a high-carbohydrate (504 kcal; CHO: 122 g; 2 g Fat or isocaloric CM (504 kcal; 84 g CHO; 28 g Pro; 7 g Fat recovery beverage. Serum creatine kinase (CK, myoglobin (Mb, muscle soreness, fatigue ratings and isometric quadriceps force (MVC were obtained prior to ITD, and following 2- and 4-days of ITD. Performance tests (T-drill, vertical jump were performed within training sessions. Treatments were administered in a randomly counterbalanced protocol, and subjects repeated the procedures with the alternate beverage following a two-week washout period. Results Mean daily training time and HR increased (p -1 compared to CHO (431.6 ± 310.8 U·L-1. No treatment differences were observed for the performance tests. Conclusions Post-exercise CM provided similar muscle recovery responses to an isocaloric CHO beverage during four-days of ITD. Future studies should investigate if the attenuated CK levels observed with CM have functional significance during more demanding periods of training.

  8. Test-retest of computerized health status questionnaires frequently used in the monitoring of knee osteoarthritis: a randomized crossover trial

    Directory of Open Access Journals (Sweden)

    Christensen Robin

    2011-08-01

    Full Text Available Abstract Background To compare data based on touch screen to data based on traditional paper versions of questionnaires frequently used to examine patient reported outcomes in knee osteoarthritis patients and to examine the impact of patient characteristics on this comparison Methods Participants were recruited from an ongoing trial (http://ClinicalTrials.Gov Identifier: NCT00655941. 20 female participants, mean age 67 (SD 7, completed KOOS, VAS pain, function and patient global, SF-36, Physical Activity Scale, painDETECT, and the ADL Taxonomy. Patients were randomly assigned to one of two subgroups, completing either the paper or touch screen version first. Mean, mean differences (95% CI, median, median differences and Intraclass Correlation Coefficients (ICCs were calculated for all questionnaires. Results ICCs between data based on computerized and paper versions ranged from 0.86 to 0.99. Analysis revealed a statistically significant difference between versions of the ADL Taxonomy, but not for the remaining questionnaires. Age, computer experience or education-level had no significant impact on the results. The computerized questionnaires were reported to be easier to use. Conclusion The computerized questionnaires gave comparable results to answers given on paper. Patient characteristics did not influence results and implementation was feasible.

  9. An Analysis of Semantic Aware Crossover

    Science.gov (United States)

    Uy, Nguyen Quang; Hoai, Nguyen Xuan; O'Neill, Michael; McKay, Bob; Galván-López, Edgar

    It is well-known that the crossover operator plays an important role in Genetic Programming (GP). In Standard Crossover (SC), semantics are not used to guide the selection of the crossover points, which are generated randomly. This lack of semantic information is the main cause of destructive effects from SC (e.g., children having lower fitness than their parents). Recently, we proposed a new semantic based crossover known GP called Semantic Aware Crossover (SAC) [25]. We show that SAC outperforms SC in solving a class of real-value symbolic regression problems. We clarify the effect of SAC on GP search in increasing the semantic diversity of the population, thus helping to reduce the destructive effects of crossover in GP.

  10. Crossover Designs in Nutrition and Dietetics Research.

    Science.gov (United States)

    Harris, Jeffrey E; Raynor, Hollie A

    2017-07-01

    This article is the 12th installment in a statistical series exploring the importance of research design, epidemiologic methods, and statistical analysis as applied to nutrition and dietetics research. The purpose of this series is to assist registered dietitian nutritionists in interpreting nutrition research and aid nutrition researchers in applying scientific principles to produce high-quality nutrition research. This article focuses on the use of crossover designs in nutrition and dietetics research. The purpose is to distinguish the crossover design from the randomized clinical trial, define important terms, illustrate a 2×2 crossover design, discuss potential confounding variables in the crossover design, describe the analysis and interpretation of crossover data, present sample size considerations, provide examples of the use of the crossover design in nutrition and dietetics, and discuss additional considerations when the independent variable has more than two levels. Copyright © 2017 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

  11. The Effects of Different Warm-up Volumes on the 100-m Swimming Performance: A Randomized Crossover Study.

    Science.gov (United States)

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

    2015-11-01

    The aim of this study was to compare the effect of 3 different warm-up (WU) volumes on 100-m swimming performance. Eleven male swimmers at the national level completed 3 time trials of 100-m freestyle on separate days and after a standard WU, a short WU (SWU), or a long WU (LWU) in a randomized sequence. All of them replicated some usual sets and drills, and the WU totaled 1,200 m, the SWU totaled 600 m, and the LWU totaled 1,800 m. The swimmers were faster after the WU (59.29 seconds; confidence interval [CI] 95%, 57.98-60.61) and after the SWU (59.38 seconds; CI 95%, 57.92-60.84) compared with the LWU (60.18 seconds; CI 95%, 58.53-61.83). The second 50-m lap after the WU was performed with a higher stroke length (effect size [ES] = 0.77), stroke index (ES = 1.26), and propelling efficiency (ES = 0.78) than that after the SWU. Both WU and SWU resulted in higher pretrial values of blood lactate concentrations [La] compared with LWU (ES = 1.58 and 0.74, respectively), and the testosterone:cortisol levels were increased in WU compared with LWU (ES = 0.86). In addition, the trial after WU caused higher [La] (ES ≥ 0.68) and testosterone:cortisol values compared with the LWU (ES = 0.93). These results suggest that an LWU could impair 100-m freestyle performance. The swimmers showed higher efficiency during the race after a 1200-m WU, suggesting a favorable situation. It highlighted the importance of the [La] and hormonal responses to each particular WU, possibly influencing performance and biomechanical responses during a 100-m race.

  12. Regulation of Lipolysis and Adipose Tissue Signaling during Acute Endotoxin-Induced Inflammation: A Human Randomized Crossover Trial.

    Science.gov (United States)

    Rittig, Nikolaj; Bach, Ermina; Thomsen, Henrik Holm; Pedersen, Steen Bønlykke; Nielsen, Thomas Sava; Jørgensen, Jens O; Jessen, Niels; Møller, Niels

    2016-01-01

    Lipolysis is accelerated during the acute phase of inflammation, a process being regulated by pro-inflammatory cytokines (e.g. TNF-α), stress-hormones, and insulin. The intracellular mechanisms remain elusive and we therefore measured pro- and anti-lipolytic signaling pathways in adipocytes after in vivo endotoxin exposure. Eight healthy, lean, male subjects were investigated using a randomized cross over trial with two interventions: i) bolus injection of saline (Placebo) and ii) bolus injection of lipopolysaccharide endotoxin (LPS). A 3H-palmitate tracer was used to measure palmitate rate of appearance (Rapalmitate) and indirect calorimetry was performed to measure energy expenditures and lipid oxidation rates. A subcutaneous abdominal fat biopsy was obtained during both interventions and subjected to western blotting and qPCR quantifications. LPS caused a mean increase in serum free fatty acids (FFA) concentrations of 90% (CI-95%: 37-142, p = 0.005), a median increase in Rapalmitate of 117% (CI-95%: 77-166, ptrend towards elevated pHSL at ser552 (p = 0.09) and cAMP-dependent protein kinase A (PKA) phosphorylation of perilipin 1 (PLIN1) (p = 0.09). Phosphatase and tensin homolog (PTEN) also tended to increase (p = 0.08) while phosphorylation of Akt at Thr308 tended to decrease (p = 0.09) during LPS compared with Placebo. There was no difference between protein or mRNA expression of ATGL, G0S2, and CGI-58. LPS stimulated lipolysis in adipose tissue and is associated with increased pHSL and signs of increased PLIN1 phosphorylation combined with a trend toward decreased insulin signaling. The combination of these mechanisms appear to be the driving forces behind the increased lipolysis observed in the early stages of acute inflammation and sepsis. ClinicalTrials.gov NCT01705782.

  13. Evaluation of levetiracetam as adjunctive treatment for refractory canine epilepsy: a randomized, placebo-controlled, crossover trial.

    Science.gov (United States)

    Muñana, K R; Thomas, W B; Inzana, K D; Nettifee-Osborne, J A; McLucas, K J; Olby, N J; Mariani, C J; Early, P J

    2012-01-01

    There is little evidence-based information available to guide treatment of refractory epilepsy in dogs. The antiepileptic drug levetiracetam (LEV) is administered to dogs, although its safety and efficacy are unknown. To evaluate the safety and efficacy of LEV as adjunctive therapy for refractory epilepsy in dogs. Thirty-four client-owned dogs with idiopathic epilepsy. Randomized, blinded trial involving dogs resistant to phenobarbital and bromide. Dogs received LEV (20 mg/kg PO q8h) or placebo for 16 weeks, and after a 4-week washout were crossed over to the alternate treatment for 16 weeks. Owners kept records on seizure frequency and adverse events. Hemogram, chemistry profile, urinalysis, and serum antiepileptic drug concentrations were evaluated at established intervals. Twenty-two (65%) dogs completed the study. Weekly seizure frequency during the 1st treatment period decreased significantly during LEV administration relative to baseline (1.9 ± 1.9 to 1.1 ± 1.3, P = .015). The reduction in seizures with LEV was not significant when compared to placebo (1.1 ± 1.3 versus 1.5 ± 1.7, P = .310). The most common adverse event was ataxia, with no difference in incidence between LEV and placebo (45 versus 18%, P = .090). No changes in laboratory parameters were identified and owners reported an improved quality of life (QOL) with LEV compared to placebo (QOL score 32.7 ± 4.3 versus 29.4 ± 4.5, P = .028). Adjunctive treatment with LEV appears safe in epileptic dogs. Efficacy of LEV over placebo was not demonstrated, although the power of the study was limited. Further evaluation of LEV as treatment for epilepsy in dogs is warranted. Copyright © 2012 by the American College of Veterinary Internal Medicine.

  14. Randomized crossover trial of a pressure sensing visual feedback system to improve mask fitting in noninvasive ventilation.

    Science.gov (United States)

    Brill, Anne-Kathrin; Moghal, Mohammad; Morrell, Mary J; Simonds, Anita K

    2017-10-01

    A good mask fit, avoiding air leaks and pressure effects on the skin are key elements for a successful noninvasive ventilation (NIV). However, delivering practical training for NIV is challenging, and it takes time to build experience and competency. This study investigated whether a pressure sensing system with real-time visual feedback improved mask fitting. During an NIV training session, 30 healthcare professionals (14 trained in mask fitting and 16 untrained) performed two mask fittings on the same healthy volunteer in a randomized order: one using standard mask-fitting procedures and one with additional visual feedback on mask pressure on the nasal bridge. Participants were required to achieve a mask fit with low mask pressure and minimal air leak (bridge, perceived comfort of mask fit and staff- confidence were measured. Compared with standard mask fitting, a lower pressure was exerted on the nasal bridge using the feedback system (71.1 ± 17.6 mm Hg vs 63.2 ± 14.6 mm Hg, P bridge (74.5 ± 21.2 mm Hg vs 66.1 ± 17.4 mm Hg, P = 0.023 and 67 ± 12.1 mm Hg vs 60 ± 10.6 mm Hg, P = 0.002, respectively) using the feedback system and self-rated confidence increased in the untrained group. Real-time visual feedback using pressure sensing technology supported healthcare professionals during mask-fitting training, resulted in a lower pressure on the skin and better mask fit for the volunteer, with increased staff confidence. © 2017 Asian Pacific Society of Respirology.

  15. Randomized comparison between provisional and routine kissing-balloon technique after main vessel crossover stenting for coronary bifurcation lesions.

    Science.gov (United States)

    Yamawaki, Masahiro; Fujita, Masaki; Sasaki, Shinya; Tsurugida, Masanori; Nanasato, Mamoru; Araki, Motoharu; Hirano, Keisuke; Ito, Yoshiaki; Tsukahara, Reiko; Muramatsu, Toshiya

    2017-04-11

    We compared the myocardial ischemic burden of provisional and routine final kissing-balloon inflation (FKI) with the 1-stent strategy using a second-generation drug-eluting stent for coronary bifurcation lesions (CBL). There are no established guidelines for side branch (SB) intervention after main vessel stenting. In total, 113 CBL patients were randomized to receive different SB intervention strategies: provisional-FKI group (n = 57; FKI only when SB flow was TIMI stress myocardial perfusion scintigraphy with (99m)Tc was performed after 8 months. The regional summed-difference score (r-SDS) was calculated according to the coronary territory. The primary endpoint included target vessel ischemia (TVI; r-SDS ≥ 2) at 8 months, whereas the clinical primary endpoint was major adverse cardiovascular events (MACE) at 3 years. The percent (%) myocardial ischemia (100 × SDS/68) was also calculated. At 8 months, TVI was identified in 11 and 4% in the provisional-FKI and routine-FKI groups, respectively (p = 0.226). SB-binary restenosis (48 vs. 4%, p 10% myocardial ischemia) was not observed in the target vessel in either group. Long-term cumulative MACE were similar between the groups (9 vs. 14%; p = 0.358). Provisional-FKI according to TIMI-SB flow grade led to similar and acceptable myocardial ischemia, in comparison with routine-FKI, which may contribute to the identical long-term follow-up.

  16. Post-Exercise Hypotension and Its Mechanisms Differ after Morning and Evening Exercise: A Randomized Crossover Study.

    Science.gov (United States)

    de Brito, Leandro C; Rezende, Rafael A; da Silva Junior, Natan D; Tinucci, Tais; Casarini, Dulce E; Cipolla-Neto, José; Forjaz, Cláudia L M

    2015-01-01

    Post-exercise hypotension (PEH), calculated by the difference between post and pre-exercise values, it is greater after exercise performed in the evening than the morning. However, the hypotensive effect of morning exercise may be masked by the morning circadian increase in blood pressure. This study investigated PEH and its hemodynamic and autonomic mechanisms after sessions of aerobic exercise performed in the morning and evening, controlling for responses observed after control sessions performed at the same times of day. Sixteen pre-hypertensive men underwent four sessions (random order): two conducted in the morning (7:30 am) and two in the evening (5 pm). At each time of day, subjects underwent an exercise (cycling, 45 min, 50%VO2peak) and a control (sitting rest) session. Measurements were taken pre- and post-interventions in all the sessions. The net effects of exercise were calculated for each time of day by [(post-pre exercise)-(post-pre control)] and were compared by paired t-test (PExercise hypotensive net effects (e.g., decreasing systolic, diastolic and mean blood pressure) occurred at both times of day, but systolic blood pressure reductions were greater after morning exercise (-7±3 vs. -3±4 mmHg, PExercise decreased cardiac output only in the morning (-460±771 ml/min, Ptimes of day and increased heart rate less in the morning than in the evening (+7±5 vs. +10±5 bpm, Pevening exercise increased sympathovagal balance (+1.5±1.6, Pexercise conducted at both times of day, but the systolic hypotensive effect is greater after morning exercise when circadian variations are considered. This greater effect is accompanied by a reduction of cardiac output due to a smaller increase in heart rate and cardiac sympathovagal balance.

  17. Osteotomy for lower third molar germectomy: randomized prospective crossover clinical study comparing piezosurgery and conventional rotatory osteotomy.

    Science.gov (United States)

    Sivolella, Stefano; Berengo, Mario; Bressan, Eriberto; Di Fiore, Adolfo; Stellini, Edoardo

    2011-06-01

    The aim of the present study was to compare piezoelectric surgery and conventional rotatory osteotomy for mandibular third molar germ extraction to determine the 2 methods' suitability and the postoperative outcomes. Mandibular third molar germectomy was performed bilaterally, randomly choosing 1 side for rotatory osteotomy (rotatory group) and the other for piezoelectric surgery (piezo group). The predictor variable was the duration of the surgical procedure. The outcome variables were the suitability of the method used, bleeding, and the postoperative parameters (ie, mouth opening range, clinical appearance of soft tissues, exudate, abscess, wound dehiscence, locoregional lymphadenopathy, pain on palpation at the extraction site, persistent edema) at 7 and 30 days postoperatively. The patients recorded their subjective postoperative pain daily for 7 days using a visual analog scale. The Wilcoxon rank-sum test and stepwise logistic regression model with binary variables were used for statistical analysis. A total of 26 patients (mean age 15.4 ± 1.29 years) were enrolled in the present study. The time needed to complete the osteotomy and extraction was significantly greater for the piezo group (15.77 ± 6.56 minutes) than for the rotatory group (11.77 ± 6.24 minutes; P = .028). No statistically significant differences emerged between the 2 methods for the other outcome variables considered. Piezoelectric osteotomy proved comparable to the rotatory method in terms of the surgeon's perception of the suitability of the 2 methods and the related postoperative sequelae. However, piezoelectric osteotomy took longer to complete than the rotatory method. Copyright © 2011 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  18. Does experimental low back pain change posteroanterior lumbar spinal stiffness and trunk muscle activity? A randomized crossover study.

    Science.gov (United States)

    Wong, Arnold Y L; Parent, Eric C; Prasad, Narasimha; Huang, Christopher; Chan, K Ming; Kawchuk, Gregory N

    2016-05-01

    While some patients with low back pain demonstrate increased spinal stiffness that decreases as pain subsides, this observation is inconsistent. Currently, the relation between spinal stiffness and low back pain remains unclear. This study aimed to investigate the effects of experimental low back pain on temporal changes in posteroanterior spinal stiffness and concurrent trunk muscle activity. In separate sessions five days apart, nine asymptomatic participants received equal volume injections of hypertonic or isotonic saline in random order into the L3-L5 interspinous ligaments. Pain intensity, spinal stiffness (global and terminal stiffness) at the L3 level, and the surface electromyographic activity of six trunk muscles were measured before, immediately after, and 25-minute after injections. These outcome measures under different saline conditions were compared by generalized estimating equations. Compared to isotonic saline injections, hypertonic saline injections evoked significantly higher pain intensity (mean difference: 5.7/10), higher global (mean difference: 0.73N/mm) and terminal stiffness (mean difference: 0.58N/mm), and increased activity of four trunk muscles during indentation (Ppain subsided. While previous clinical research reported inconsistent findings regarding the association between spinal stiffness and low back pain, our study revealed that experimental pain caused temporary increases in spinal stiffness and concurrent trunk muscle co-contraction during indentation, which helps explain the temporal relation between spinal stiffness and low back pain observed in some clinical studies. Our results substantiate the role of spinal stiffness assessments in monitoring back pain progression. Copyright © 2016 Elsevier Ltd. All rights reserved.

  19. Amino acid supplementation is anabolic during the acute phase of endotoxin-induced inflammation: A human randomized crossover trial.

    Science.gov (United States)

    Rittig, N; Bach, E; Thomsen, H H; Johannsen, M; Jørgensen, J O; Richelsen, B; Jessen, N; Møller, N

    2016-04-01

    Inflammation is catabolic and causes muscle loss. It is unknown if amino acid supplementation reverses these effects during the acute phase of inflammation. The aim was to test whether amino acid supplementation counteracts endotoxin-induced catabolism. Eight young, healthy, lean males were investigated three times in randomized order: (i) normal conditions (Placebo), (ii) endotoxemia (LPS), and (iii) endotoxemia with amino acid supplementation (LPS + A). Protein kinetics were determined using phenylalanine, tyrosine, and urea tracers. Each study day consisted of a four-hour non-insulin stimulated period and a two-hour hyperinsulinemic euglycemic clamp period. Muscle biopsies were collected once each period. Endotoxin administration created a significant inflammatory response (cytokines, hormones, and vital parameters) without significant differences between LPS and LPS + A. Whole body protein breakdown was elevated during LPS compared with Placebo and LPS + A (p translation factor 4E-binding protein 1 (4EBP1) phosphorylation (p = 0.007) without activating AMPK or affecting insulin signaling through Akt. During insulin stimulation net muscle phenylalanine release and protein degradation were further reduced. Amino acid supplementation in the acute phase of inflammation reduces whole body and muscle protein loss, and this effect is associated with activation of mTOR and downstream signaling to protein synthesis through mTORC1, suggesting a therapeutic role for intravenous amino acids in inflammatory states. The Central Denmark Region Ethics Commitee (1-10-71-410-12) www.clinicaltrials.gov (identification number NCT01705782). Copyright © 2015 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  20. Immediate effects of somatosensory stimulation on hand function in patients with poststroke hemiparesis: a randomized cross-over trial.

    Science.gov (United States)

    Sim, Sun-Mi; Oh, Duck-Won; Chon, Seung-chul

    2015-12-01

    This study aimed to determine the immediate effects of somatosensory stimulation on hand function in patients with poststroke hemiparesis. Eleven patients with poststroke hemiparesis participated in this study. Four types (no stimulation, vibration, and light and rough touches) of somatosensory stimulation were performed randomly for 4 days applying only one type of somatosensory stimulation each day. The box and block test (BBT), the Jebsen-Taylor hand function test (JTHFT), hand grip strength (HGS), and movement distance and peak velocity of the wrist joint during a forward-reaching task were measured. The BBT and JTHFT scores for no stimulation [BBT: median (interquartile range), 0.00 (-1.00 to 1.00) and JTHFT: 2.57 (-0.47 to 4.92)] were significantly different from those for vibration [BBT: 3.00 (2.00-5.00) and JTHFT: -16.02 (-23.06 to -4.31)], light touch [BBT: 3.00 (1.00-4.00) and JTHFT: -5.00 (-21.20 to -0.94)], and rough touch [BBT: 2.00 (1.00-4.00) and JTHFT: -6.19 (-18.22 to -3.70)]. The JTHFT score was significantly higher for vibration than that for rough touch (P<0.05). The increase in HGS was significantly greater for light touch than that for no stimulation (P<0.05) and for vibration than that for light touch (P<0.05). There were significant differences for the sagittal and coronal planes in movement distance and for the sagittal and horizontal planes in peak velocity during the forward-reaching task (P<0.05). The findings suggest that somatosensory stimulation may be advantageous to improve the hand function of patients with poststroke hemiparesis, with more favorable effects observed in vibration stimulation.

  1. Effects of brain-directed nutrients on cerebral blood flow and neuropsychological testing: a randomized, double-blind, placebo-controlled, crossover trial.

    Science.gov (United States)

    Amen, Daniel G; Taylor, Derek V; Ojala, Kristine; Kaur, Jasleen; Willeumier, Kristen

    2013-01-01

    In a prior open trial of professional football players who displayed the effects of traumatic brain injury, the current reserach team reported significant improvements in clinical symptoms, neuropsychological testing and regional cerebral blood flow (rCBF) following the use of brain-directed nutrients (BDNs) and lifestyle interventions. The current study intended to determine whether supplementation with BDNs improved rCBF and neuropsychological function in healthy individuals. The current study was a randomized, doubleblind, placebo-controlled, crossover trial, which was a more rigorous reseach design than the prior study and did not include lifestyle interventions. Participants underwent evaluation and testing at the Amen Clinics, Inc, a private medical facility in Newport Beach, CA. Thirty healthy adult (15 male and 15 female) participants were recruited from the community though local advertising and met the requirements for eligibility into the study. Twenty-five individuals completed the study, with dropout due to events unrelated to the study itself. The participants were randomly assigned to a treatment order for intervention, either placebo or brain supplements first. The BDNs treatment was comprised of three supplements: fish oil; a high-potency, multiple vitamin/mineral supplement; and a brainenhancement supplement. The placebo treatment was two supplements comprised of rice flour to replace the multiple vitamin/mineral complex and the brain-enhancement supplement and one supplement made of other oils to replace the fish-oil mixture. After 2 mo of this first intervention, a crossover intervention occurred for a final 2 mo, in which participants formerly receiving BDNs received a placebo treatment and participants formerly treated with placebo received the BDNs treatment. Primary outcome measures included (1) an analysis of the changes in rCBF using SPECT and (2) an assessment of the differences in cognitive and emotional function using the Micro

  2. Decomposing Multifractal Crossovers

    Directory of Open Access Journals (Sweden)

    Zoltan Nagy

    2017-07-01

    Full Text Available Physiological processes—such as, the brain's resting-state electrical activity or hemodynamic fluctuations—exhibit scale-free temporal structuring. However, impacts common in biological systems such as, noise, multiple signal generators, or filtering by transport function, result in multimodal scaling that cannot be reliably assessed by standard analytical tools that assume unimodal scaling. Here, we present two methods to identify breakpoints or crossovers in multimodal multifractal scaling functions. These methods incorporate the robust iterative fitting approach of the focus-based multifractal formalism (FMF. The first approach (moment-wise scaling range adaptivity allows for a breakpoint-based adaptive treatment that analyzes segregated scale-invariant ranges. The second method (scaling function decomposition method, SFD is a crossover-based design aimed at decomposing signal constituents from multimodal scaling functions resulting from signal addition or co-sampling, such as, contamination by uncorrelated fractals. We demonstrated that these methods could handle multimodal, mono- or multifractal, and exact or empirical signals alike. Their precision was numerically characterized on ideal signals, and a robust performance was demonstrated on exemplary empirical signals capturing resting-state brain dynamics by near infrared spectroscopy (NIRS, electroencephalography (EEG, and blood oxygen level-dependent functional magnetic resonance imaging (fMRI-BOLD. The NIRS and fMRI-BOLD low-frequency fluctuations were dominated by a multifractal component over an underlying biologically relevant random noise, thus forming a bimodal signal. The crossover between the EEG signal components was found at the boundary between the δ and θ bands, suggesting an independent generator for the multifractal δ rhythm. The robust implementation of the SFD method should be regarded as essential in the seamless processing of large volumes of bimodal f

  3. Decomposing Multifractal Crossovers

    Science.gov (United States)

    Nagy, Zoltan; Mukli, Peter; Herman, Peter; Eke, Andras

    2017-01-01

    Physiological processes—such as, the brain's resting-state electrical activity or hemodynamic fluctuations—exhibit scale-free temporal structuring. However, impacts common in biological systems such as, noise, multiple signal generators, or filtering by transport function, result in multimodal scaling that cannot be reliably assessed by standard analytical tools that assume unimodal scaling. Here, we present two methods to identify breakpoints or crossovers in multimodal multifractal scaling functions. These methods incorporate the robust iterative fitting approach of the focus-based multifractal formalism (FMF). The first approach (moment-wise scaling range adaptivity) allows for a breakpoint-based adaptive treatment that analyzes segregated scale-invariant ranges. The second method (scaling function decomposition method, SFD) is a crossover-based design aimed at decomposing signal constituents from multimodal scaling functions resulting from signal addition or co-sampling, such as, contamination by uncorrelated fractals. We demonstrated that these methods could handle multimodal, mono- or multifractal, and exact or empirical signals alike. Their precision was numerically characterized on ideal signals, and a robust performance was demonstrated on exemplary empirical signals capturing resting-state brain dynamics by near infrared spectroscopy (NIRS), electroencephalography (EEG), and blood oxygen level-dependent functional magnetic resonance imaging (fMRI-BOLD). The NIRS and fMRI-BOLD low-frequency fluctuations were dominated by a multifractal component over an underlying biologically relevant random noise, thus forming a bimodal signal. The crossover between the EEG signal components was found at the boundary between the δ and θ bands, suggesting an independent generator for the multifractal δ rhythm. The robust implementation of the SFD method should be regarded as essential in the seamless processing of large volumes of bimodal fMRI-BOLD imaging data for

  4. Multicenter, double-blind, randomized, intraindividual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine for MR angiography of peripheral arteries.

    Science.gov (United States)

    Gerretsen, Suzanne C; le Maire, Thierry F; Miller, Stephan; Thurnher, Siegfried A; Herborn, Christoph U; Michaely, Henrik J; Kramer, Harald; Vanzulli, Angelo; Vymazal, Josef; Wasser, Martin N; Ballarati, Claudio E M; Kirchin, Miles A; Pirovano, Gianpaolo; Leiner, Tim

    2010-06-01

    To prospectively compare the image quality and diagnostic performance achieved with doses of gadobenate dimeglumine and gadopentetate dimeglumine of 0.1 mmol per kilogram of body weight in patients undergoing contrast material-enhanced magnetic resonance (MR) angiography of the pelvis, thigh, and lower-leg (excluding foot) for suspected or known peripheral arterial occlusive disease. Institutional review board approval was granted from each center and informed written consent was obtained from all patients. Between November 2006 and January 2008, 96 patients (62 men, 34 women; mean age, 63.7 years +/- 10.4 [standard deviation]; range, 39-86 years) underwent two identical examinations at 1.5 T by using three-dimensional spoiled gradient-echo sequences and randomized 0.1-mmol/kg doses of each agent. Images were evaluated on-site for technical adequacy and quality of vessel visualization and offsite by three independent blinded readers for anatomic delineation and detection/exclusion of pathologic features. Comparative diagnostic performance was determined in 31 patients who underwent digital subtraction angiography. Data were analyzed by using the Wilcoxon signed-rank, McNemar, and Wald tests. Interreader agreement was determined by using generalized kappa statistics. Differences in quantitative contrast enhancement were assessed and a safety evaluation was performed. Ninety-two patients received both agents. Significantly better performance (P dimeglumine was noted on-site for technical adequacy and vessel visualization quality and offsite for anatomic delineation and detection/exclusion of pathologic features. Contrast enhancement (P dimeglumine. Interreader agreement for stenosis detection and grading was good to excellent (kappa = 0.749 and 0.805, respectively). Mild adverse events were reported for four (six events) and five (eight events) patients after gadobenate dimeglumine and gadopentetate dimeglumine, respectively. Higher-quality vessel visualization

  5. Post-Exercise Hypotension and Its Mechanisms Differ after Morning and Evening Exercise: A Randomized Crossover Study.

    Directory of Open Access Journals (Sweden)

    Leandro C de Brito

    Full Text Available Post-exercise hypotension (PEH, calculated by the difference between post and pre-exercise values, it is greater after exercise performed in the evening than the morning. However, the hypotensive effect of morning exercise may be masked by the morning circadian increase in blood pressure. This study investigated PEH and its hemodynamic and autonomic mechanisms after sessions of aerobic exercise performed in the morning and evening, controlling for responses observed after control sessions performed at the same times of day. Sixteen pre-hypertensive men underwent four sessions (random order: two conducted in the morning (7:30 am and two in the evening (5 pm. At each time of day, subjects underwent an exercise (cycling, 45 min, 50%VO2peak and a control (sitting rest session. Measurements were taken pre- and post-interventions in all the sessions. The net effects of exercise were calculated for each time of day by [(post-pre exercise-(post-pre control] and were compared by paired t-test (P<0.05. Exercise hypotensive net effects (e.g., decreasing systolic, diastolic and mean blood pressure occurred at both times of day, but systolic blood pressure reductions were greater after morning exercise (-7±3 vs. -3±4 mmHg, P<0.05. Exercise decreased cardiac output only in the morning (-460±771 ml/min, P<0.05, while it decreased stroke volume similarly at both times of day and increased heart rate less in the morning than in the evening (+7±5 vs. +10±5 bpm, P<0.05. Only evening exercise increased sympathovagal balance (+1.5±1.6, P<0.05 and calf blood flow responses to reactive hyperemia (+120±179 vs. -70±188 U, P<0.05. In conclusion, PEH occurs after exercise conducted at both times of day, but the systolic hypotensive effect is greater after morning exercise when circadian variations are considered. This greater effect is accompanied by a reduction of cardiac output due to a smaller increase in heart rate and cardiac sympathovagal balance.

  6. Regulation of Lipolysis and Adipose Tissue Signaling during Acute Endotoxin-Induced Inflammation: A Human Randomized Crossover Trial.

    Directory of Open Access Journals (Sweden)

    Nikolaj Rittig

    Full Text Available Lipolysis is accelerated during the acute phase of inflammation, a process being regulated by pro-inflammatory cytokines (e.g. TNF-α, stress-hormones, and insulin. The intracellular mechanisms remain elusive and we therefore measured pro- and anti-lipolytic signaling pathways in adipocytes after in vivo endotoxin exposure.Eight healthy, lean, male subjects were investigated using a randomized cross over trial with two interventions: i bolus injection of saline (Placebo and ii bolus injection of lipopolysaccharide endotoxin (LPS. A 3H-palmitate tracer was used to measure palmitate rate of appearance (Rapalmitate and indirect calorimetry was performed to measure energy expenditures and lipid oxidation rates. A subcutaneous abdominal fat biopsy was obtained during both interventions and subjected to western blotting and qPCR quantifications.LPS caused a mean increase in serum free fatty acids (FFA concentrations of 90% (CI-95%: 37-142, p = 0.005, a median increase in Rapalmitate of 117% (CI-95%: 77-166, p<0.001, a mean increase in lipid oxidation of 49% (CI-95%: 1-96, p = 0.047, and a median increase in energy expenditure of 28% (CI-95%: 16-42, p = 0.001 compared with Placebo. These effects were associated with increased phosphorylation of hormone sensitive lipase (pHSL at ser650 in adipose tissue (p = 0.03, a trend towards elevated pHSL at ser552 (p = 0.09 and cAMP-dependent protein kinase A (PKA phosphorylation of perilipin 1 (PLIN1 (p = 0.09. Phosphatase and tensin homolog (PTEN also tended to increase (p = 0.08 while phosphorylation of Akt at Thr308 tended to decrease (p = 0.09 during LPS compared with Placebo. There was no difference between protein or mRNA expression of ATGL, G0S2, and CGI-58.LPS stimulated lipolysis in adipose tissue and is associated with increased pHSL and signs of increased PLIN1 phosphorylation combined with a trend toward decreased insulin signaling. The combination of these mechanisms appear to be the driving forces

  7. Implications of different application sites on the bioavailability of a transdermal contraceptive patch containing ethinyl estradiol and gestodene: an open-label, randomized, crossover study.

    Science.gov (United States)

    Höchel, Joachim; Schuett, Barbara; Ludwig, Matthias; Zurth, Christian

    2014-10-01

    A novel once-a-week contraceptive patch delivers the same systemic exposure seen with a combined oral contraceptive pill containing 0.02 mg ethinyl estradiol (EE) and 0.06 mg gestodene (GSD). This study evaluated the relative bioavailability of EE and GSD after application of this patch to three different sites. In this phase I, open-label, randomized, intra-individual comparison, crossover study, 43 women (aged 18 - 45 years) were randomized to one of six treatment sequences. Patches were applied to two test sites (buttocks and outer, upper arm) and one comparator site (lower abdomen). In each treatment period, four patches were worn for 7 days each, followed by a 7-day, patch-free interval. The primary objective was to investigate the relative bioavailability of transdermally administered EE and GSD between test and comparator sites using the primary variable area under the concentration- time curve (AUC(0-168)) during week 4 of each period. Of the 43 women who were randomized, 43 were included in the set for safety evaluation and 40 were included in the set for pharmacokinetic (PK) analysis. Three subjects were excluded from the PK analysis as they failed to complete the study. AUC(0-168) for EE and GSD were equal when the patch was applied to buttocks or abdomen (AUC(0-168) ratios: EE, 1.07 (94% confidence interval, CI: 0.994 - 1.16); GSD, 1.02 (94% CI: 0.946 - 1.10)). Relative bioavailabilities for EE and GSD were 31% and 24% higher, respectively, for arm vs. abdomen. AUC(0-168) 94% CI for the arm/abdomen ratio exceeded the pre-defined bioequivalence range of 80 - 125% (EE: 1.21 - 1.42; GSD: 1.15 - 1.34). Other PK parameters were correspondingly higher for arm vs. buttocks or abdomen. Patch adhesion and tolerability were good, with no relevant differences between sites. Differences in systemic EE/GSD exposure following patch application to the outer, upper arm vs. lower abdomen and buttocks are unlikely to be clinically relevant, and there were no relevant

  8. The impact of nurse-driven targeted HIV screening in 8 emergency departments: study protocol for the DICI-VIH cluster-randomized two-period crossover trial.

    Science.gov (United States)

    Leblanc, Judith; Rousseau, Alexandra; Hejblum, Gilles; Durand-Zaleski, Isabelle; de Truchis, Pierre; Lert, France; Costagliola, Dominique; Simon, Tabassome; Crémieux, Anne-Claude

    2016-02-01

    In 2010, to reduce late HIV diagnosis, the French national health agency endorsed non-targeted HIV screening in health care settings. Despite these recommendations, non-targeted screening has not been implemented and only physician-directed diagnostic testing is currently performed. A survey conducted in 2010 in 29 French Emergency Departments (EDs) showed that non-targeted nurse-driven screening was feasible though only a few new HIV diagnoses were identified, predominantly among high-risk groups. A strategy targeting high-risk groups combined with current practice could be shown to be feasible, more efficient and cost-effective than current practice alone. DICI-VIH (acronym for nurse-driven targeted HIV screening) is a multicentre, cluster-randomized, two-period crossover trial. The primary objective is to compare the effectiveness of 2 strategies for diagnosing HIV among adult patients visiting EDs: nurse-driven targeted HIV screening combined with current practice (physician-directed diagnostic testing) versus current practice alone. Main secondary objectives are to compare access to specialist consultation and how early HIV diagnosis occurs in the course of the disease between the 2 groups, and to evaluate the implementation, acceptability and cost-effectiveness of nurse-driven targeted screening. The 2 strategies take place during 2 randomly assigned periods in 8 EDs of metropolitan Paris, where 42 % of France's new HIV patients are diagnosed every year. All patients aged 18 to 64, not presenting secondary to HIV exposure are included. During the intervention period, patients are invited to fill a 7-item questionnaire (country of birth, sexual partners and injection drug use) in order to select individuals who are offered a rapid test. If the rapid test is reactive, a follow-up visit with an infectious disease specialist is scheduled within 72 h. Assuming an 80 % statistical power and a 5 % type 1 error, with 1.04 and 3.38 new diagnoses per 10,000 patients in

  9. Efficacy and safety of premedication with single dose of oral pregabalin in children with dental anxiety: A randomized double-blind placebo-controlled crossover clinical trial

    Directory of Open Access Journals (Sweden)

    Tahereh Eskandarian

    2015-01-01

    Full Text Available Background: Dental anxiety is a relatively frequent problem that can lead to more serious problems such as a child entering a vicious cycle as he/she becomes reluctant to accept the required dental treatments. The aim of this randomized double-blind clinical trial study was to evaluate the anxiolytic and sedative effect of pregabalin in children. Materials and Methods: Twenty-five children were randomized to a double-blind placebo-controlled crossover clinical trial. Two visits were scheduled for each patient. At the first visit, 75 mg pregabalin or placebo was given randomly, and the alternative was administered at the next visit. Anxiolytic and sedative effects were measured using the visual analogue scale. The child′s behavior was rated with the Frankl behavioral rating scale and the sedation level during the dental procedure was scored using the Ramsay sedation scale. The unpaired, two-tailed Student′s t-test was used to compare the mean changes of visual analog scale (VAS for anxiety in the pregabalin group with that of the placebo group. A repeated measures MANOVA model was used to detect differences in sedation level in the pregabalin and placebo groups regarding the interaction of 3-time measurements; sub-group analysis was performed using Student′s t-test. The Mann-Whitney U-test was used to analyze the nonparametric data of the Frankl and Ramsay scales. A P < 0.05 was considered significant. Results: The reduction of the VAS-anxiety score from 2 h post-dose was statistically significant in the pregabalin group. From 2 h to 4 h post-dose, the VAS-sedation score increased significantly in the pregabalin group. The child′s behavior rating was not significantly different between the groups. The number of "successful" treatment visits was higher in the pregabalin group compared to the placebo group. Conclusion: Significant anxiolytic and sedative effects can be anticipated 2 h after oral administration of pregabalin without serious

  10. A Web-Based Telehealth Training Platform Incorporating Automated Nonverbal Behavior Feedback for Teaching Communication Skills to Medical Students: A Randomized Crossover Study.

    Science.gov (United States)

    Liu, Chunfeng; Lim, Renee L; McCabe, Kathryn L; Taylor, Silas; Calvo, Rafael A

    2016-09-12

    In the interests of patient health outcomes, it is important for medical students to develop clinical communication skills. We previously proposed a telehealth communication skills training platform (EQClinic) with automated nonverbal behavior feedback for medical students, and it was able to improve medical students' awareness of their nonverbal communication. This study aimed to evaluate the effectiveness of EQClinic to improve clinical communication skills of medical students. We conducted a 2-group randomized crossover trial between February and June 2016. Participants were second-year medical students enrolled in a clinical communication skills course at an Australian university. Students were randomly allocated to complete online EQClinic training during weeks 1-5 (group A) or to complete EQClinic training during weeks 8-11 (group B). EQClinic delivered an automated visual presentation of students' nonverbal behavior coupled with human feedback from a standardized patient (SP). All students were offered two opportunities to complete face-to-face consultations with SPs. The two face-to-face consultations were conducted in weeks 6-7 and 12-13 for both groups, and were rated by tutors who were blinded to group allocation. Student-Patient Observed Communication Assessment (SOCA) was collected by blinded assessors (n=28) at 2 time points and also by an SP (n=83). Tutor-rated clinical communications skill in face-to-face consultations was the primary outcome and was assessed with the SOCA. We used t tests to examine the students' performance during face-to-face consultations pre- and postexposure to EQClinic. We randomly allocated 268 medical students to the 2 groups (group A: n=133; group B: n=135). SOCA communication skills measures (score range 4-16) from the first face-to-face consultation were significantly higher for students in group A who had completed EQClinic training and reviewed the nonverbal behavior feedback, compared with group B, who had completed

  11. 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

    2017-11-27

    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 < 0.001) under OXA compared to placebo. Median attack duration was 4 s (Q25: 2 s, Q75: 120 s) under OXA, and 3 s (Q25: 2 s, Q75: 60 s) under placebo treatment. When days with no attacks, i.e., duration = 0, were included in the analysis, these

  12. Two-dimensional linear discriminant analysis for classification of three-way chemical data.

    Science.gov (United States)

    Silva, Adenilton C da; Soares, Sófacles F C; Insausti, Matías; Galvão, Roberto K H; Band, Beatriz S F; Araújo, Mário César U de

    2016-09-28

    The two-dimensional linear discriminant analysis (2D-LDA) algorithm was originally proposed in the context of face image processing for the extraction of features with maximal discriminant power. However, despite its promising performance in image processing tasks, the 2D-LDA algorithm has not yet been used in applications involving chemical data. The present paper bridges this gap by investigating the use of 2D-LDA in classification problems involving three-way spectral data. The investigation was concerned with simulated data, as well as real-life data sets involving the classification of dry-cured Parma ham according to ageing by surface autofluorescence spectrometry and the classification of edible vegetable oils according to feedstock using total synchronous fluorescence spectrometry. The results were compared with those obtained by using the spectral data with no feature extraction, U-PLS-DA (Partial Least Squares Discriminant Analysis applied to the unfolded data), and LDA employing TUCKER-3 or PARAFAC scores. In the simulated data set, all methods yielded a correct classification rate of 100%. However, in the Parma ham and vegetable oil data sets, better classification rates were obtained by using 2D-LDA (86% and 100%), compared with no feature extraction (76% and 77%), U-PLS-DA (81% and 92%), PARAFAC-LDA (76% and 86%) and TUCKER3-LDA (86% and 93%). Published by Elsevier B.V.

  13. Degrees-of-Freedom of the MIMO Three-Way Channel with Node-Intermittency

    KAUST Repository

    Neu, Joachim

    2017-08-28

    The characterization of fundamental performance bounds of many-to-many communication systems in which participating nodes are active in an intermittent way is one of the major challenges in communication theory. In order to address this issue, we introduce the multiple-input multiple-output (MIMO) three-way channel (3WC) with an intermittent node and study its degrees-of-freedom (DoF) region and sum-DoF. We devise a non-adaptive encoding scheme based on zero-forcing, interference alignment and erasure coding, and show its DoF region (and thus sum-DoF) optimality for non-intermittent 3WCs and its sum-DoF optimality for (node-)intermittent 3WCs. However, we show by example that in general some DoF tuples in the intermittent 3WC can only be achieved by adaptive schemes, such as multi-hop or decode-forward relaying. This shows that non-adaptive encoding is sufficient for the non-intermittent 3WC and for the sum-DoF of intermittent 3WCs, but adaptive encoding is necessary for the DoF region of intermittent 3WCs. Our work contributes to a better understanding of the fundamental limits of multi-way communication systems with intermittency and the impact of adaptation therein.

  14. On the degrees-of-freedom of the MIMO three-way channel with intermittent connectivity

    KAUST Repository

    Chaaban, Anas

    2017-08-29

    The degrees-of-freedom (DoF) of the multi-antenna three-way channel (3WC) with an intermittent node is studied. Special attention is given to the impact of adaptation when the intermittent node has the largest number of antennas. A non-adaptive transmission scheme based on interference alignment, zero-forcing, and erasure-channel treatment is proposed, and its corresponding DoF region is derived. Then, it is shown that this scheme achieves the sum-DoF of the intermittent channel, in addition to the DoF region of the nonintermittent one. Thus, adaptation is not necessary from those perspectives. To the contrary, it is shown that adaptation is necessary for achieving the DoF region of the intermittent case. This is shown by deriving an outer bound for the intermittent channel with nonadaptive encoding, and proposing an adaptive scheme which achieves DoF tuples outside this bound. This highlights the importance of cooperation in this intermittent network.

  15. Simulation three-way catalyst ageing. Analysis of two conventional catalyst

    Energy Technology Data Exchange (ETDEWEB)

    Martin, L.; Arranz, J.L.; Galan, M.A. [Departamento de Ingenieria Quimica y Textil, Universidad de Salamanca, Salamanca (Spain); Prieto, O.; Trujillano, R.; Holgado, M.J.; Rives, V. [Departamento de Quimica Inorganica, Universidad de Salamanca, Plaza de la Merced s/n 1-5, 37008 Salamanca (Spain)

    2003-08-08

    Two commercial automobile three-way catalysts (RENAULT) of different configuration: (I) Pt, Rh active phase supported on ceria-promoted alumina washcoat, and (II) Pd, Rh active phase supported on zirconia-ceria-promoted alumina washcoat on cordierite supports, have been compared fresh and aged in a conventional automobile for 100,000km in order to design and to adjust a catalyst ageing method suitable to imitate most relevant conditions of real tests. The characterization techniques were N{sub 2} adsorption-desorption isotherms, powder X-Ray diffraction, elemental chemical analysis and activity tests. Activity tests were: (1) CO, NO and CH{sub 4} conversion versus temperature (from 120 to 500C), and (2) CO, NO and CH{sub 4} conversion versus the ratio between the concentrations of the oxidant and reducing species ({lambda}) at 500C (normal running temperature). Gas composition was close to conventional engine exhaust composition with and without water vapour. A strong deactivation has been observed as a consequence of thermal processes and loss of catalyst washcoat mainly for catalyst (II). Poison concentration along the catalyst has also been shown, however, its influence on catalyst deactivation was not as important as thermal processes were.

  16. Three-Way Channels With Multiple Unicast Sessions: Capacity Approximation via Network Transformation

    KAUST Repository

    Chaaban, Anas

    2016-09-28

    A network of three nodes mutually communicating with each other is studied. This multi-way network is a suitable model for three-user device-to-device communications. The main goal of this paper is to characterize the capacity region of the underlying Gaussian three-way channel (3WC) within a constant gap. To this end, a capacity outer bound is derived using cut-set bounds and genie-aided bounds. For achievability, the 3WC is first transformed into an equivalent star channel. This latter is then decomposed into a set of “successive” sub-channels, leading to a sub-channel allocation problem. Using backward decoding, interference neutralization, and known results on the capacity of the star-channel relying of physical-layer network coding, an achievable rate region for the 3WC is obtained. It is then shown that the achievable rate region is within a constant gap of the developed outer bound, leading to the desired capacity approximation. Interestingly, in contrast to the Gaussian two-way channel (TWC), adaptation is necessary in the 3WC. Furthermore, message splitting is another ingredient of the developed scheme for the 3WC, which is not required in the TWC. The two setups are, however, similar in terms of their sum-capacity pre-log, which is equal to 2. Finally, some interesting networks and their approximate capacities are recovered as special cases of the 3WC, such as the cooperative broadcast channel and multiple access channel.

  17. Non-parametric three-way mixed ANOVA with aligned rank tests.

    Science.gov (United States)

    Oliver-Rodríguez, Juan C; Wang, X T

    2015-02-01

    Research problems that require a non-parametric analysis of multifactor designs with repeated measures arise in the behavioural sciences. There is, however, a lack of available procedures in commonly used statistical packages. In the present study, a generalization of the aligned rank test for the two-way interaction is proposed for the analysis of the typical sources of variation in a three-way analysis of variance (ANOVA) with repeated measures. It can be implemented in the usual statistical packages. Its statistical properties are tested by using simulation methods with two sample sizes (n = 30 and n = 10) and three distributions (normal, exponential and double exponential). Results indicate substantial increases in power for non-normal distributions in comparison with the usual parametric tests. Similar levels of Type I error for both parametric and aligned rank ANOVA were obtained with non-normal distributions and large sample sizes. Degrees-of-freedom adjustments for Type I error control in small samples are proposed. The procedure is applied to a case study with 30 participants per group where it detects gender differences in linguistic abilities in blind children not shown previously by other methods. © 2013 The British Psychological Society.

  18. Thermally-induced microstructural changes in a three-way automotive catalyst

    Energy Technology Data Exchange (ETDEWEB)

    More, K.L.; Kenik, E.A.; Coffey, D.W.; Geer, T.S. [Oak Ridge National Lab., TN (United States); Theis, J.; LaBarge, W.; Beckmeyer, R. [Delphi Automotive Systems, Flint, MI (United States)

    1997-12-01

    The use of advanced electron microscopy techniques to characterize both the bulk and near-atomic level microstructural evolution of catalyst materials during different dynamometer/vehicle aging cycles is an integral part of understanding catalyst deactivation. The study described here was undertaken to evaluate thermally-induced microstructural changes which caused the progressive loss of catalyst performance in a three-way automotive catalyst. Several different catalyst processing variables, for example changing the washcoat ceria content, were also evaluated as a function of aging cycle and thermal history. A number of thermally-induced microstructural changes were identified using high resolution electron microscopy techniques that contributed to the deactivation of the catalyst, including sintering of all washcoat constituents, {gamma}-alumina transforming to {alpha}-, {beta}-, and {delta}-alumina, precious metal redistribution, and constituent encapsulation. The data accumulated in this study have been used to correlate microstructural evolution with thermal history and catalyst performance during various aging cycles and to subsequently evaluate different washcoat formulations for increased thermal stability.

  19. Thermodynamic stabilities of three-way junction nanomotifs in prohead RNA.

    Science.gov (United States)

    Hill, Alyssa C; Schroeder, Susan J

    2017-04-01

    The thermodynamic stabilities of four natural prohead or packaging RNA (pRNA) three-way junction (3WJ) nanomotifs and seven phi29 pRNA 3WJ deletion mutant nanomotifs were investigated using UV optical melting on a three-component RNA system. Our data reveal that some pRNA 3WJs are more stable than the phi29 pRNA 3WJ. The stability of the 3WJ contributes to the unique self-assembly properties of pRNA. Thus, ultrastable pRNA 3WJ motifs suggest new scaffolds for pRNA-based nanotechnology. We present data demonstrating that pRNA 3WJs differentially respond to the presence of metal ions. A comparison of our data with free energies predicted by currently available RNA secondary structure prediction programs shows that these programs do not accurately predict multibranch loop stabilities. These results will expand the existing parameters used for RNA secondary structure prediction from sequence in order to better inform RNA structure-function hypotheses and guide the rational design of functional RNA supramolecular assemblies. © 2017 Hill and Schroeder; Published by Cold Spring Harbor Laboratory Press for the RNA Society.

  20. Celecoxib in the treatment of primary dysmenorrhea: results from two randomized, double-blind, active- and placebo-controlled, crossover studies.

    Science.gov (United States)

    Daniels, Stephen; Robbins, Jeffery; West, Christine R; Nemeth, Mary Anne

    2009-06-01

    Celecoxib, a cyclooxygenase-2 inhibitor, has established analgesic efficacy for the treatment of acute pain resulting from a variety of causes. This article describes 2 studies designed to assess the efficacy and tolerability of celecoxib in patients with primary dysmenorrhea. Two identical, 3-day, multiple-dose, randomized, double-blind, active- and placebo-controlled, crossover studies were carried out in women aged 18 to 44 years with primary dysmenorrhea (studies 1 and 2). The studies employed a 6-sequence, 3-period, complete-block crossover design over 3 menstrual cycles. Patients received celecoxib 400 mg, followed by celecoxib 200 mg no sooner than 12 hours after first dose (day 1), then celecoxib 200 mg q12h as necessary (days 2 and 3); naproxen sodium 550 mg followed by naproxen sodium 550 mg no sooner than 12 hours after first dose (day 1), then naproxen sodium 550 mg q12h as necessary (days 2 and 3); or placebo. Primary efficacy measures were time-weighted sum of total pain relief and time-weighted sum of pain intensity difference at 8 hours after administration of the first dose of study medication (TOTPAR[8] and SPID[8], respectively). Tolerability was assessed using routine physical examination, including vital sign measurements, and clinical laboratory analyses at screening and end of study. In total, 149 and 154 patients were randomized to 1 of the 6 treatment sequences in studies 1 and 2, respectively. Across treatment sequences, mean age ranges were 23.4 to 26.9 years (study 1) and 28.3 to 34.1 years (study 2). Mean weight ranges were 62.7 to 74.5 kg (study 1) and 69.2 to 86.7 kg (study 2). Most patients (96.6% in study 1, 80.5% in study 2) were white. Mean TOTPAR[8] values with celecoxib (study 1/study 2, 18.28/17.98) and naproxen sodium (20.59/21.27) were significantly greater than with placebo (12.82/12.98) (all, P < 0.001). Mean SPID[8] values were significantly greater with celecoxib (10.06/9.60) and naproxen sodium (11.48/11.71) than with

  1. 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

  2. Effects of Oral L-Carnitine Administration in Narcolepsy Patients: A Randomized, Double-Blind, Cross-Over and Placebo-Controlled Trial

    Science.gov (United States)

    Miyagawa, Taku; Kawamura, Hiromi; Obuchi, Mariko; Ikesaki, Asuka; Ozaki, Akiko; Tokunaga, Katsushi; Inoue, Yuichi; Honda, Makoto

    2013-01-01

    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 PMID:23349733

  3. Isotretinoin conundrum: a randomized, openlabel, crossover study in Mexico to evaluate the bioavailability and bioequivalence of three pharmaceutical preparations of isotretinoin in healthy participants.

    Science.gov (United States)

    Piñeyro-Garza, Everardo; Gómez-Silva, Magdalena; Gamino Peña, María Elena; Palmer, Jonathan; Berber, Arturo

    2015-10-01

    The oral retinoid agent isotretinoin (13-cis-retinoic acid) is approved for the treatment of severe recalcitrant cystic acne. For registrational renewal of Oratane® in Mexico (isotretinoin; Laboratorios Dermatologicos Darier S.A. de C.V., Mexico), it was necessary to establish bioequivalence to the reference product Roaccutan® (Isotretinoin; Roche, Mannheim, Germany). Three prior studies failed to establish the bioequivalence of Oratane to Mexican-sourced Roaccutan. However, 13 studies demonstrated the bioequivalence of Oratane to Roaccutane® from multiple sources. This study compared the bioavailability of Oratane with that of Mexicansourced Roaccutan and Australian-sourced Roaccutane. Study participants received each of the three agents in a randomized, open-label, 6-sequence, 3-way crossover study with a 2-week washout period between treatments. Pharmacokinetic analysis revealed that peak plasma concentration (Cmax) and area under the plasma concentration-time curve from time 0 (dosing) to infinite time (AUC0-∞) were lower for Roaccutan than for Roaccutane and Oratane (Cmax: 1,023.35, 1,223.08, and 1,224.25 ng/mL, respectively; AUC0-∞: 13,653.65, 15,681.35 and 15,733.55 ng/mL x h, respectively). The 90% CIs (test/reference) for the ratios of the geometric means indicated that Oratane was bioequivalent to Roaccutane but not to Roaccutan. In addition, Roaccutane (R2) was not bioequivalent to Roaccutan (R1; R1/R2 90% CIs: Cmax, 76.12 - 91.04; AUC0-t, 82.19 - 91.13; AUC0-∞, 82.94 - 91.57). Oratane and Australian-sourced Roaccutane could be considered bioequivalent, but neither formulation was found to be bioequivalent to Mexican-sourced Roaccutan.

  4. Effect of hawthorn standardized extract on flow mediated dilation in prehypertensive and mildly hypertensive adults: a randomized, controlled cross-over trial.

    Science.gov (United States)

    Asher, Gary N; Viera, Anthony J; Weaver, Mark A; Dominik, Rosalie; Caughey, Melissa; Hinderliter, Alan L

    2012-03-29

    Hawthorn extract has been used for cardiovascular diseases for centuries. Recent trials have demonstrated its efficacy for the treatment of heart failure, and the results of several small trials suggest it may lower blood pressure. However, there is little published evidence to guide its dosing. The blood pressure lowering effect of hawthorn has been linked to nitric oxide-mediated vasodilation. The aim of this study was to investigate the relationship between hawthorn extract dose and brachial artery flow mediated dilation (FMD), an indirect measure of nitric oxide release. We used a four-period cross-over design to evaluate brachial artery FMD in response to placebo or hawthorn extract (standardized to 50 mg oligomeric procyanidin per 250 mg extract). Randomly sequenced doses of hawthorn extract (1000 mg, 1500 mg, and 2500 mg) and placebo were assigned to each participant. Doses were taken twice daily for 3 1/2 days followed by FMD and a 4-day washout before proceeding to the next dosing period. Twenty-one prehypertensive or mildly hypertensive adults completed the study. There was no evidence of a dose-response effect for our main outcome (FMD percent) or any of our secondary outcomes (absolute change in brachial artery diameter and blood pressure). Most participants indicated that if given evidence that hawthorn could lower their blood pressure, they would be likely to use it either in conjunction with or instead of lifestyle modification or anti-hypertensive medications. We found no evidence of a dose-response effect of hawthorn extract on FMD. If hawthorn has a blood pressure lowering effect, it is likely to be mediated via an NO-independent mechanism. This trial has been registered with ClinicalTrials.gov, a service of the U.S. National Institutes of Health: NCT01331486.

  5. The biphasic effects of moderate alcohol consumption with a meal on ambiance-induced mood and autonomic nervous system balance: a randomized crossover trial.

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    Ilse C Schrieks

    Full Text Available BACKGROUND: The pre-drinking mood state has been indicated to be an important factor in the mood effects of alcohol. However, for moderate alcohol consumption there are no controlled studies showing this association. Also, the mood effects of consuming alcohol combined with food are largely unknown. The aim of this study was to investigate the effects of moderate alcohol combined with a meal on ambiance-induced mood states. Furthermore effects on autonomic nervous system activity were measured to explore physiological mechanisms that may be involved in changes of mood state. METHODS: In a crossover design 28 women (age 18-45 y, BMI 18.5-27 kg/m2 were randomly allocated to 4 conditions in which they received 3 glasses of sparkling white wine (30 g alcohol or alcohol-free sparkling white wine while having dinner in a room with either a pleasant or unpleasant created ambiance. Subjects filled out questionnaires (B-BAES, POMS and postprandial wellness questionnaire at different times. Skin conductance and heart rate variability were measured continuously. RESULTS: Moderate alcohol consumption increased happiness scores in the unpleasant, but not in the pleasant ambiance. Alcohol consumption increased happiness and stimulation feelings within 1 hour and increased sedative feelings and sleepiness for 2.5 hour. Skin conductance was increased after alcohol within 1 hour and was related to happiness and stimulation scores. Heart rate variability was decreased after alcohol for 2 hours and was related to mental alertness. CONCLUSION: Mood inductions and autonomic nervous system parameters may be useful to evaluate mood changes by nutritional interventions. Moderate alcohol consumption elevates happiness scores in an unpleasant ambiance. However, drinking alcohol during a pleasant mood results in an equally positive mood state. TRIAL REGISTRATION: Clinicaltrials.gov NCT01426022.

  6. Effects of Ayurvedic Oil-Dripping Treatment with Sesame Oil vs. with Warm Water on Sleep: A Randomized Single-Blinded Crossover Pilot Study.

    Science.gov (United States)

    Tokinobu, Akiko; Yorifuji, Takashi; Tsuda, Toshihide; Doi, Hiroyuki

    2016-01-01

    Ayurvedic oil-dripping treatment (Shirodhara) is often used for treating sleep problems. However, few properly designed studies have been conducted, and the quantitative effect of Shirodhara is unclear. This study sought to quantitatively evaluate the effect of sesame oil Shirodhara (SOS) against warm water Shirodhara (WWS) on improving sleep quality and quality of life (QOL) among persons reporting sleep problems. This randomized, single-blinded, crossover study recruited 20 participants. Each participant received seven 30-minute sessions within 2 weeks with either liquid. The washout period was at least 2 months. The Shirodhara procedure was conducted by a robotic oil-drip system. The outcomes were assessed by the Pittsburgh Sleep Quality Index (PSQI) for sleep quality, Epworth Sleepiness Scale (ESS) for daytime sleepiness, World Health Organization Quality of Life 26 (WHO-QOL26) for QOL, and a sleep monitor instrument for objective sleep measures. Changes between baseline and follow-up periods were compared between the two types of Shirodhara. Analysis was performed with generalized estimating equations. Of 20 participants, 15 completed the study. SOS improved sleep quality, as measured by PSQI. The SOS score was 1.83 points lower (95% confidence interval [CI], -3.37 to -0.30) at 2-week follow-up and 1.73 points lower (95% CI, -3.84 to 0.38) than WWS at 6-week follow-up. Although marginally significant, SOS also improved QOL by 0.22 points at 2-week follow-up and 0.19 points at 6-week follow-up compared with WWS. After SOS, no beneficial effects were observed on daytime sleepiness or objective sleep measures. This pilot study demonstrated that SOS may be a safe potential treatment to improve sleep quality and QOL in persons with sleep problems.

  7. A fish-based diet intervention improves endothelial function in postmenopausal women with type 2 diabetes mellitus: a randomized crossover trial.

    Science.gov (United States)

    Kondo, Keiko; Morino, Katsutaro; Nishio, Yoshihiko; Kondo, Motoyuki; Nakao, Keiko; Nakagawa, Fumiyuki; Ishikado, Atsushi; Sekine, Osamu; Yoshizaki, Takeshi; Kashiwagi, Atsunori; Ugi, Satoshi; Maegawa, Hiroshi

    2014-07-01

    The beneficial effects of fish and n-3 polyunsaturated fatty acids (PUFAs) consumption on atherosclerosis have been reported in numerous epidemiological studies. However, to the best of our knowledge, the effects of a fish-based diet intervention on endothelial function have not been investigated. Therefore, we studied these effects in postmenopausal women with type 2 diabetes mellitus (T2DM). Twenty-three postmenopausal women with T2DM were assigned to two four-week periods of either a fish-based diet (n-3 PUFAs ≧ 3.0 g/day) or a control diet in a randomized crossover design. Endothelial function was measured with reactive hyperemia using strain-gauge plethysmography and compared with the serum levels of fatty acids and their metabolites. Endothelial function was determined with peak forearm blood flow (Peak), duration of reactive hyperemia (Duration) and flow debt repayment (FDR). A fish-based dietary intervention improved Peak by 63.7%, Duration by 27.9% and FDR by 70.7%, compared to the control diet. Serum n-3 PUFA levels increased after the fish-based diet period and decreased after the control diet, compared with the baseline (1.49 vs. 0.97 vs. 1.19 mmol/l, p diet intervention, possibly due to the inhibition of the activity of soluble epoxide hydrolase. A fish-based dietary intervention improves endothelial function in postmenopausal women with T2DM. Dissociation between the serum n-3 PUFA concentration and endothelial function suggests that the other factors may contribute to this phenomenon. Copyright © 2014 Elsevier Inc. All rights reserved.

  8. Influence of Erythropoietin on Cognitive Performance during Experimental Hypoglycemia in Patients with Type 1 Diabetes Mellitus: A Randomized Cross-Over Trial

    Science.gov (United States)

    Kristensen, Peter Lommer; Pedersen-Bjergaard, Ulrik; Kjær, Troels Wesenberg; Olsen, Niels Vidiendal; Dela, Flemming; Holst, Jens Juul; Faber, Jens; Tarnow, Lise; Thorsteinsson, Birger

    2013-01-01

    Introduction 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. Materials and Methods 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. Results 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. Conclusion 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. Trial Registration ClinicalTrials.gov NCT00615368 PMID:23577069

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

    Science.gov (United States)

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

    2017-09-01

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

  10. A higher-complex carbohydrate diet in gestational diabetes mellitus achieves glucose targets and lowers postprandial lipids: a randomized crossover study.

    Science.gov (United States)

    Hernandez, Teri L; Van Pelt, Rachael E; Anderson, Molly A; Daniels, Linda J; West, Nancy A; Donahoo, William T; Friedman, Jacob E; Barbour, Linda A

    2014-01-01

    The conventional diet approach to gestational diabetes mellitus (GDM) advocates carbohydrate restriction, resulting in higher fat (HF), also a substrate for fetal fat accretion and associated with maternal insulin resistance. Consequently, there is no consensus about the ideal GDM diet. We hypothesized that, compared with a conventional, lower-carbohydrate/HF diet (40% carbohydrate/45% fat/15% protein), consumption of a higher-complex carbohydrate (HCC)/lower-fat (LF) Choosing Healthy Options in Carbohydrate Energy (CHOICE) diet (60/25/15%) would result in 24-h glucose area under the curve (AUC) profiles within therapeutic targets and lower postprandial lipids. Using a randomized, crossover design, we provided 16 GDM women (BMI 34 ± 1 kg/m2) with two 3-day isocaloric diets at 31 ± 0.5 weeks (washout between diets) and performed continuous glucose monitoring. On day 4 of each diet, we determined postprandial (5 h) glucose, insulin, triglycerides (TGs), and free fatty acids (FFAs) following a controlled breakfast meal. There were no between-diet differences for fasting or mean nocturnal glucose, but 24-h AUC was slightly higher (∼6%) on the HCC/LF CHOICE diet (P = 0.02). The continuous glucose monitoring system (CGMS) revealed modestly higher 1- and 2-h postprandial glucose on CHOICE (1 h, 115 ± 2 vs. 107 ± 3 mg/dL, P ≤ 0.01; 2 h, 106 ± 3 vs. 97 ± 3 mg/dL, P = 0.001) but well below current targets. After breakfast, 5-h glucose and insulin AUCs were slightly higher (P carbohydrates and reducing fat still achieved glycemia below current treatment targets and lower postprandial FFAs. This diet strategy may have important implications for preventing macrosomia.

  11. 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.

  12. Effect of hawthorn standardized extract on flow mediated dilation in prehypertensive and mildly hypertensive adults: a randomized, controlled cross-over trial

    Directory of Open Access Journals (Sweden)

    Asher Gary N

    2012-03-01

    Full Text Available Abstract Background Hawthorn extract has been used for cardiovascular diseases for centuries. Recent trials have demonstrated its efficacy for the treatment of heart failure, and the results of several small trials suggest it may lower blood pressure. However, there is little published evidence to guide its dosing. The blood pressure lowering effect of hawthorn has been linked to nitric oxide-mediated vasodilation. The aim of this study was to investigate the relationship between hawthorn extract dose and brachial artery flow mediated dilation (FMD, an indirect measure of nitric oxide release. Methods We used a four-period cross-over design to evaluate brachial artery FMD in response to placebo or hawthorn extract (standardized to 50 mg oligomeric procyanidin per 250 mg extract. Randomly sequenced doses of hawthorn extract (1000 mg, 1500 mg, and 2500 mg and placebo were assigned to each participant. Doses were taken twice daily for 3 1/2 days followed by FMD and a 4-day washout before proceeding to the next dosing period. Results Twenty-one prehypertensive or mildly hypertensive adults completed the study. There was no evidence of a dose-response effect for our main outcome (FMD percent or any of our secondary outcomes (absolute change in brachial artery diameter and blood pressure. Most participants indicated that if given evidence that hawthorn could lower their blood pressure, they would be likely to use it either in conjunction with or instead of lifestyle modification or anti-hypertensive medications. Conclusion We found no evidence of a dose-response effect of hawthorn extract on FMD. If hawthorn has a blood pressure lowering effect, it is likely to be mediated via an NO-independent mechanism. Trial Registration This trial has been registered with ClinicalTrials.gov, a service of the U.S. National Institutes of Health: NCT01331486.

  13. Should the amounts of fat and protein be taken into consideration to calculate the lunch prandial insulin bolus? Results from a randomized crossover trial.

    Science.gov (United States)

    García-López, José Manuel; González-Rodriguez, María; Pazos-Couselo, Marcos; Gude, Francisco; Prieto-Tenreiro, Alma; Casanueva, Felipe

    2013-02-01

    Concerning continuous subcutaneous insulin infusion (CSII), there are controversial results related to changes in glycemic response according to the meal composition and bolus design. Our aim is to determine whether the presence of protein and fat in a meal could involve a different postprandial glycemic response than that obtained with only carbohydrates (CHs). This was a crossover, randomized clinical trial. Seventeen type 1 diabetes (T1D) patients on CSII wore a blinded continuous glucose monitoring system sensor for 3 days. They ingested two meals (meal 1 vs. meal 2) with the same CH content (50 g) but different fat (8.9 g vs. 37.4 g) and protein (3.3 g vs. 28.9 g) contents. A single-wave insulin bolus was used, and the interstitial glucose values were measured every 30 min for 3 h. We evaluated the different postprandial glycemic response between meal 1 and meal 2 by using mixed-effects models. The postmeal glucose increase was 22 mg/dL for meal 1 and 31 mg/dL for meal 2. In univariate analysis, at different times not statistically significant differences in glucose levels between meals occurred. In mixed-model analysis, a time×meal interaction was found, indicating a different response between treatments along the time. However, most of the patients remained in the normoglycemic range (70-180 mg/dL) during the 3-h postmeal period (84.4% for meal 1 and 93.1% for meal 2). The presence of balanced amounts of protein and fat determined a different glycemic response from that obtained with only CH up to 3 h after eating. The clinical relevance of this finding remains to be elucidated.

  14. Antioxidant Effects of a Hydroxytyrosol-Based Pharmaceutical Formulation on Body Composition, Metabolic State, and Gene Expression: A Randomized Double-Blinded, Placebo-Controlled Crossover Trial

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    Carmela Colica

    2017-01-01

    Full Text Available Hydroxytyrosol (HT plays a significant role in cardiovascular disease (CVD protection, and its metabolites are able to protect from the endothelial dysfunction commonly present in atherosclerosis. This randomized double-blinded, placebo-controlled crossover trial determined the effect in healthy volunteers of two gastroresistant capsules containing 15 mg/day of HT, for a 3-week period (HTT. Evaluation of nutritional status, serum metabolites, oxidative stress biomarkers, and gene expression of 9 genes related to oxidative stress, inflammation, and CVDs was performed. Oxidation biomarkers like thiol group (p=0.001, total antioxidant status (TAS (p=0.001, superoxide dismutase 1 (SOD1 (2−ΔΔCt = 3.7, and plasma concentration of HT (2.83 μg·mL−1 were significantly increased, while nitrite (p=0.001, nitrate (p=0.001, and malondialdehyde (MDA (p=0.02 were drastically reduced after HTT. A significant reduction of body fat mass percentage (p=0.01, suprailiac skinfold (p=0.01, and weight (p=0.04; Δ% = −0.46% was observed after HTT. This study shows that regular intake of 15 mg/day of HT changed body composition parameters and modulated the antioxidant profile and the expression of inflammation and oxidative stress-related genes. However, it is advisable to personalize HT doses in order to exert its health benefits in CVD prevention and protection of LDL-C particles from oxidative damage. This trial is registered with ClinicalTrials.gov NCT01890070.

  15. Doxycycline-mediated effects on persistent symptoms and systemic cytokine responses post-neuroborreliosis: a randomized, prospective, cross-over study

    Science.gov (United States)

    2012-01-01

    Background Persistent symptoms after treatment of neuroborreliosis (NB) are well-documented, although the causative mechanisms are mainly unknown. The effect of repeated antibiotic treatment has not been studied in detail. The aim of this study was to determine whether: (1) persistent symptoms improve with doxycycline treatment; (2) doxycycline has an influence on systemic cytokine responses, and; (3) improvement of symptoms could be due to doxycycline-mediated immunomodulation. Methods/Design 15 NB patients with persistent symptoms ≥6 months post-treatment were double-blindly randomized to receive 200 mg of doxycycline or a placebo for three weeks. After a six-week wash-out period, a cross-over with a three-week course of a placebo or doxycycline was conducted. The primary outcome measures were improvement of persistent symptoms assessed by neurological examinations, a symptom severity score and estimation of the quality of life. The secondary outcome measure was changes in systemic cytokine responses. Results All 15 patients finished the study. No doxycycline-mediated improvement of post-treatment symptoms or quality of life was observed. Nor could any doxycycline-mediated changes in systemic cytokine responses be detected. The study was completed without any serious adverse events. Discussion No doxycycline-mediated improvement of post-treatment symptoms or quality of life was observed. Nor could any doxycycline-mediated changes in systemic cytokine responses be detected. The study was completed without any serious adverse events. To conclude, in this pilot study, doxycycline-treatment did not lead to any improvement of either the persistent symptoms or quality of life in post-NB patients. Accordingly, doxycycline does not seem to be the optimal treatment of diverse persistent symptoms post-NB. However, the results need to be confirmed in larger studies. Trial registration NCT01205464 (clinicaltrials.gov) PMID:22876748

  16. Acute Effects of Nitrate-Rich Beetroot Juice on Blood Pressure, Hemostasis and Vascular Inflammation Markers in Healthy Older Adults: A Randomized, Placebo-Controlled Crossover Study

    Directory of Open Access Journals (Sweden)

    Kyle Raubenheimer

    2017-11-01

    Full Text Available Aging is associated with a vasoconstrictive, pro-coagulant, and pro-inflammatory profile of arteries and a decline in the bioavailability of the endothelium-derived molecule nitric oxide. Dietary nitrate elicits vasodilatory, anti-coagulant and anti-inflammatory effects in younger individuals, but little is known about whether these benefits are evident in older adults. We investigated the effects of 140 mL of nitrate-rich (HI-NI; containing 12.9 mmol nitrate versus nitrate-depleted beetroot juice (LO-NI; containing ≤0.04 mmol nitrate on blood pressure, blood coagulation, vascular inflammation markers, plasma nitrate and nitrite before, and 3 h and 6 h after ingestion in healthy older adults (five males, seven females, mean age: 64 years, age range: 57–71 years in a randomized, placebo-controlled, crossover study. Plasma nitrate and nitrite increased 3 and 6 h after HI-NI ingestion (p < 0.05. Systolic, diastolic and mean arterial blood pressure decreased 3 h relative to baseline after HI-NI ingestion only (p < 0.05. The number of blood monocyte-platelet aggregates decreased 3 h after HI-NI intake (p < 0.05, indicating reduced platelet activation. The number of blood CD11b-expressing granulocytes decreased 3 h following HI-NI beetroot juice intake (p < 0.05, suggesting a shift toward an anti-adhesive granulocyte phenotype. Numbers of blood CD14++CD16+ intermediate monocyte subtypes slightly increased 6 h after HI-NI beetroot juice ingestion (p < 0.05, but the clinical implications of this response are currently unclear. These findings provide new evidence for the acute effects of nitrate-rich beetroot juice on circulating immune cells and platelets. Further long-term research is warranted to determine if these effects reduce the risk of developing hypertension and vascular inflammation with aging.

  17. Effects of sea buckthorn and bilberry on serum metabolites differ according to baseline metabolic profiles in overweight women: a randomized crossover trial1234

    Science.gov (United States)

    Larmo, Petra S; Kangas, Antti J; Soininen, Pasi; Lehtonen, Henna-Maria; Suomela, Jukka-Pekka; Yang, Baoru; Viikari, Jorma; Ala-Korpela, Mika; Kallio, Heikki P

    2013-01-01

    Background: Berries are associated with health benefits. Little is known about the effect of baseline metabolome on the overall metabolic responses to berry intake. Objective: We studied the effects of berries on serum metabolome. Design: Eighty overweight women completed this randomized crossover study. During the interventions of 30 d, subjects consumed dried sea buckthorn berries (SBs), sea buckthorn oil (SBo), sea buckthorn phenolics ethanol extract mixed with maltodextrin (SBe+MD) (1:1), or frozen bilberries. Metabolic profiles were quantified from serum samples by using 1H nuclear magnetic resonance spectroscopy. Results: All interventions induced a significant (P < 0.001–0.003) effect on the overall metabolic profiles. The effect was observed both in participants who had a metabolic profile that reflected higher cardiometabolic risk at baseline (group B: P = 0.001–0.008) and in participants who had a lower-risk profile (group A: P < 0.001–0.009). Although most of the changes in individual metabolites were not statistically significant after correction for multiplicity, clear trends were observed. SB-induced effects were mainly on serum triglycerides and very-low-density lipoprotein (VLDL) and its subclasses, which decreased in metabolic group B. SBo induced a decreasing trend in serum total, intermediate-density lipoprotein (IDL), and low-density lipoprotein (LDL) cholesterol and subfractions of IDL and LDL in group B. During the SBe+MD treatment, VLDL fractions and serum triglycerides increased. Bilberries caused beneficial changes in serum lipids and lipoproteins in group B, whereas the opposite was true in group A. Conclusion: Berry intake has overall metabolic effects, which depend on the cardiometabolic risk profile at baseline. This trial was registered at clinicaltrials.gov as NCT01860547. PMID:23945716

  18. Effects of sea buckthorn and bilberry on serum metabolites differ according to baseline metabolic profiles in overweight women: a randomized crossover trial.

    Science.gov (United States)

    Larmo, Petra S; Kangas, Antti J; Soininen, Pasi; Lehtonen, Henna-Maria; Suomela, Jukka-Pekka; Yang, Baoru; Viikari, Jorma; Ala-Korpela, Mika; Kallio, Heikki P

    2013-10-01

    Berries are associated with health benefits. Little is known about the effect of baseline metabolome on the overall metabolic responses to berry intake. We studied the effects of berries on serum metabolome. Eighty overweight women completed this randomized crossover study. During the interventions of 30 d, subjects consumed dried sea buckthorn berries (SBs), sea buckthorn oil (SBo), sea buckthorn phenolics ethanol extract mixed with maltodextrin (SBe+MD) (1:1), or frozen bilberries. Metabolic profiles were quantified from serum samples by using (1)H nuclear magnetic resonance spectroscopy. All interventions induced a significant (P < 0.001-0.003) effect on the overall metabolic profiles. The effect was observed both in participants who had a metabolic profile that reflected higher cardiometabolic risk at baseline (group B: P = 0.001-0.008) and in participants who had a lower-risk profile (group A: P < 0.001-0.009). Although most of the changes in individual metabolites were not statistically significant after correction for multiplicity, clear trends were observed. SB-induced effects were mainly on serum triglycerides and very-low-density lipoprotein (VLDL) and its subclasses, which decreased in metabolic group B. SBo induced a decreasing trend in serum total, intermediate-density lipoprotein (IDL), and low-density lipoprotein (LDL) cholesterol and subfractions of IDL and LDL in group B. During the SBe+MD treatment, VLDL fractions and serum triglycerides increased. Bilberries caused beneficial changes in serum lipids and lipoproteins in group B, whereas the opposite was true in group A. Berry intake has overall metabolic effects, which depend on the cardiometabolic risk profile at baseline. This trial was registered at clinicaltrials.gov as NCT01860547.

  19. Intake and time dependence of blueberry flavonoid-induced improvements in vascular function: a randomized, controlled, double-blind, crossover intervention study with mechanistic insights into biological activity.

    Science.gov (United States)

    Rodriguez-Mateos, Ana; Rendeiro, Catarina; Bergillos-Meca, Triana; Tabatabaee, Setareh; George, Trevor W; Heiss, Christian; Spencer, Jeremy Pe

    2013-11-01

    There