WorldWideScience

Sample records for controlled crossover trial

  1. Cross-Over Clinical Trials?

    Directory of Open Access Journals (Sweden)

    Latif Gachkar

    2017-01-01

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

  2. Effects of a Worksite Weight-Control Programme in Obese Male Workers: A Randomized Controlled Crossover Trial

    Science.gov (United States)

    Iriyama, Yae; Murayama, Nobuko

    2014-01-01

    Objective: We conducted a randomized controlled crossover trial to evaluate the effects of a new worksite weight-control programme designed for men with or at risk of obesity using a combination of nutrition education and nutrition environmental interventions. Subjects and methods: Male workers with or at risk of obesity were recruited for this…

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

    DEFF Research Database (Denmark)

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

    2008-01-01

    Serotonin (5-HT) is involved in pain modulation via descending pathways in the central nervous system. The aim of this study was to test if escitalopram, a selective serotonin reuptake inhibitor (SSRI), would relieve pain in polyneuropathy. The study design was a randomized, double-blind, placebo......-controlled cross-over trial. The daily dose of escitalopram was 20mg once daily. During the two treatment periods of 5 weeks duration, patients rated pain relief (primary outcome variable) on a 6-point ordered nominal scale. Secondary outcome measures comprised total pain and different pain symptoms (touch...

  4. A preliminary placebo-controlled crossover trial of fludrocortisone for chronic fatigue syndrome.

    Science.gov (United States)

    Peterson, P K; Pheley, A; Schroeppel, J; Schenck, C; Marshall, P; Kind, A; Haugland, J M; Lambrecht, L J; Swan, S; Goldsmith, S

    1998-04-27

    To provide a preliminary assessment of the efficacy and safety of fludrocortisone acetate treatment of chronic fatigue syndrome. A placebo-controlled, double-blind, random-allocation crossover trial of 6 weeks of fludrocortisone. An outpatient clinical trials unit. Twenty-five participants with chronic fatigue syndrome (mean age, 40 years; 19 [76%] women; mean duration of illness, 7.0 years) were recruited from a research and clinic registry. Five patients withdrew from the trial. All participants were scheduled to receive fludrocortisone acetate (0.1-0.2 mg) or a placebo for 6 weeks in each treatment. Self-administered questionnaires were completed at the beginning and end of each treatment arm that asked patients to rate the severity of their symptoms on a visual analogue scale. The Medical Outcomes Study 36-Item Short-Form Health Survey, a reaction time test, and a treadmill exercise test were used to assess functional status. Blood pressure, heart rate, and plasma norepinephrine levels were obtained at baseline. Blood pressure and heart rate were recorded at the end of the exercise test and monitored at all subsequent visits. At baseline, the study participants reported symptom severity greater than 5 for most symptoms, and all had evidence of marked functional impairments. No improvement was observed in the severity of any symptom or in any test of function for the 20 participants who completed both arms of the trial. Blood pressure and heart rate readings were unaffected by treatment, and plasma norepinephrine levels did not differ from those of a healthy control group. The incidence of adverse experiences was similar in the fludrocortisone and placebo arms of the trial. Low-dose fludrocortisone does not provide sufficient benefit to be evident in a preliminary blinded trial of unselected patients with chronic fatigue syndrome.

  5. 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...

  6. Communication interventions to improve adherence to infection control precautions: a randomised crossover trial.

    Science.gov (United States)

    Ong, Mei-Sing; Magrabi, Farah; Post, Jeffrey; Morris, Sarah; Westbrook, Johanna; Wobcke, Wayne; Calcroft, Ross; Coiera, Enrico

    2013-02-06

    Ineffective communication of infection control requirements during transitions of care is a potential cause of non-compliance with infection control precautions by healthcare personnel. In this study, interventions to enhance communication during inpatient transfers between wards and radiology were implemented, in the attempt to improve adherence to precautions during transfers. Two interventions were implemented, comprising (i) a pre-transfer checklist used by radiology porters to confirm a patient's infectious status; (ii) a coloured cue to highlight written infectious status information in the transfer form. The effectiveness of the interventions in promoting adherence to standard precautions by radiology porters when transporting infectious patients was evaluated using a randomised crossover trial at a teaching hospital in Australia. 300 transfers were observed over a period of 4 months. Compliance with infection control precautions in the intervention groups was significantly improved relative to the control group (p group was 38%. Applying the coloured cue resulted in a compliance rate of 73%. The pre-transfer checklist intervention achieved a comparable compliance rate of 71%. When both interventions were applied, a compliance rate of 74% was attained. Acceptability of the coloured cue was high, but adherence to the checklist was low (40%). Simple measures to enhance communication through the provision of a checklist and the use a coloured cue brought about significant improvement in compliance with infection control precautions by transport personnel during inpatient transfers. The study underscores the importance of effective communication in ensuring compliance with infection control precautions during transitions of care.

  7. 1% hydrocortisone ointment is an effective treatment of pruritus ani: a pilot randomized controlled crossover trial.

    Science.gov (United States)

    Al-Ghnaniem, R; Short, K; Pullen, A; Fuller, L C; Rennie, J A; Leather, A J M

    2007-12-01

    Pruritus ani (PA) is a common condition which is difficult to treat in the absence of obvious predisposing factors. There is paucity of evidence-based guidelines on the treatment of this condition. We examined whether 1% hydrocortisone ointment is an effective treatment for PA. A pilot randomized, double-blind, placebo-controlled, crossover trial was carried out. Eleven patients consented to take part in the trial and ten completed the study. After a 2-week run-in period, patients with primary PA were randomly allocated to receive 1% hydrocortisone ointment or placebo for 2 weeks followed by the opposite treatment for a further 2-week period. There was a washout period of 2 weeks between treatments. The primary outcome measure was reduction in itch using a visual analogue score (VAS). The secondary outcome measures were improvement in quality of life measured using a validated questionnaire (Dermatology Life Quality Index, DLQI) and improvement in clinical appearance of the perianal skin using the Eczema Area and Severity Index (EASI) score. Treatment with 1% hydrocortisone ointment resulted in a 68% reduction in VAS compared with placebo (P=0.019), a 75% reduction in DLQI score (P=0.067), and 81% reduction in EASI score (P=0.01). A short course of mild steroid ointment is an effective treatment for PA.

  8. Bright Light for Weight Loss: Results of a Controlled Crossover Trial

    Directory of Open Access Journals (Sweden)

    Konstantin V. Danilenko

    2013-02-01

    Full Text Available Objective: To investigate whether bright light treatment can reduce body mass in overweight subjects irrespective of their seasonal (= light dependence. Methods: A crossover, placebo-controlled, randomized clinical trial was performed between November and April in Novosibirsk, Russia (55° N. The trial comprised a 3-week in-home session of morning bright light treatment using a device of light-emitting diodes and a 3-week placebo session by means of a deactivated ion generator, separated by an off-protocol period of at least 23 days. The number of placebo and light sessions was matched with respect to season. Data were obtained from 34 overweight women, aged 20-54 years, 10 were seasonal-dependent according to the Seasonal Pattern Assessment Questionnaire. Weekly measures included body weight, percentage body fat by bioimpedancemetry, and subjective scores (appetite, mood, energy levels. Results: Motivation and expectation towards weight loss were similar for the two intervention sessions. With light, compared to the placebo session, weight did not reduce significantly, but percentage fat, fat mass, and appetite were significantly lower (average fat reduction 0.35 kg. The latter two results remained significant after excluding seasonal-dependent subjects from the analysis. Irrespective of the type of intervention, seasonal-dependent subjects had greater weight and fat mass changes during treatment (decline p 0.036 or between sessions (regain p 0.003. Photoperiod (p = 0.0041, air temperature to a lesser extent (p = 0.012, but not sunshine (p = 0.29 was associated with the weight change (greater weight reduction if the second session was in spring. Conclusion: Morning bright light treatment reduces body fat and appetite in overweight women and may be included in weight control programs.

  9. In vitro testing to diagnose venom allergy and monitor immunotherapy: a placebo-controlled, crossover trial.

    Science.gov (United States)

    Brown, S G A; Haas, M A; Black, J A; Parameswaran, A; Woods, G M; Heddle, R J

    2004-05-01

    In people with a history of sting allergy, only prior reaction severity and older age are known to predict subsequent reaction risk. Furthermore, no diagnostic test other than a deliberate sting challenge has been found to identify people in whom venom immunotherapy (VIT) has been unsuccessful. We aimed to assess the utility of a number of in vitro tests to diagnose venom allergy and to monitor immunotherapy. During a double-blind randomized placebo-controlled crossover trial of Myrmecia pilosula ant VIT the following venom-specific tests were performed at enrolment, and at completion of treatment prior to a diagnostic sting challenge; leucocyte stimulation index (SI), IL-4 production, IgE RAST, histamine release test (HRT), leukotriene release test (LRT) and basophil activation test (BAT). Intradermal venom skin testing (VST) was also performed at trial entry. Only VST and HRT identified those at risk of sting anaphylaxis in the placebo group. Although IgE RAST, leucocyte SI and IL-4 production, LRT and BAT all correlated well with intradermal VSTs, they did not predict sting challenge outcome. After successful VIT, venom-induced leucocyte IL-4 production tended to fall, whereas IgE RAST increased and a natural decline in HRT reactivity was reversed. A confounding seasonal affect on laboratory results was suspected. The HRT warrants further assessment for diagnosis of venom allergy. Uninformative performance of the commercially available LRT and BAT tests may be due to pre-incubation with IL-3. None of the tests evaluated appear to be reliable markers of successful VIT.

  10. 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.

  11. The effect of almonds on inflammation and oxidative stress in Chinese patients with type 2 diabetes mellitus: a randomized crossover controlled feeding trial

    Science.gov (United States)

    Almond consumption is associated with ameliorations in obesity, hyperlipidemia, hypertension, and hyperglycemia. The hypothesis of this 12-wk randomized, crossover, controlled feeding trial was that almond consumption would ameliorate inflammation and oxidative stress in Chinese patients with type 2...

  12. Glycomacropeptide for nutritional management of phenylketonuria: a randomized, controlled, crossover trial12

    Science.gov (United States)

    Stroup, Bridget M; Clayton, Murray K; Murali, Sangita G; Rice, Gregory M; Rohr, Frances; Levy, Harvey L

    2016-01-01

    Background: To prevent cognitive impairment, phenylketonuria requires lifelong management of blood phenylalanine (Phe) concentration with a low-Phe diet. The diet restricts intake of Phe from natural proteins in combination with traditional amino acid medical foods (AA-MFs) or glycomacropeptide medical foods (GMP-MFs) that contain primarily intact protein and a small amount of Phe. Objective: We investigated the efficacy and safety of a low-Phe diet combined with GMP-MFs or AA-MFs providing the same quantity of protein equivalents in free-living subjects with phenylketonuria. Design: This 2-stage, randomized crossover trial included 30 early-treated phenylketonuria subjects (aged 15–49 y), 20 with classical and 10 with variant phenylketonuria. Subjects consumed, in random order for 3 wk each, their usual low-Phe diet combined with AA-MFs or GMP-MFs. The treatments were separated by a 3-wk washout with AA-MFs. Fasting plasma amino acid profiles, blood Phe concentrations, food records, and neuropsychological tests were obtained. Results: The frequency of medical food intake was higher with GMP-MFs than with AA-MFs. Subjects rated GMP-MFs as more acceptable than AA-MFs and noted improved gastrointestinal symptoms and less hunger with GMP-MFs. ANCOVA indicated no significant mean ± SE increase in plasma Phe (62 ± 40 μmol/L, P = 0.136), despite a significant increase in Phe intake from GMP-MFs (88 ± 6 mg Phe/d, P = 0.026). AA-MFs decreased plasma Phe (−85 ± 40 μmol/L, P = 0.044) with stable Phe intake. Blood concentrations of Phe across time were not significantly different (AA-MFs = 444 ± 34 μmol/L, GMP-MFs = 497 ± 34 μmol/L), suggesting similar Phe control. Results of the Behavior Rating Inventory of Executive Function were not significantly different. Conclusions: GMP-MFs provide a safe and acceptable option for the nutritional management of phenylketonuria. The greater acceptability and fewer side effects noted with GMP-MFs than with AA-MFs may enhance

  13. Ketamine for Social Anxiety Disorder: A Randomized, Placebo-Controlled Crossover Trial.

    Science.gov (United States)

    Taylor, Jerome H; Landeros-Weisenberger, Angeli; Coughlin, Catherine; Mulqueen, Jilian; Johnson, Jessica A; Gabriel, Daniel; Reed, Margot O; Jakubovski, Ewgeni; Bloch, Michael H

    2018-01-01

    Many patients with social anxiety disorder (SAD) experience inadequate symptom relief from available treatments. Ketamine is a potent N-methyl-D-aspartate receptor antagonist with a potentially novel mechanism of action for the treatment of anxiety disorders. Therefore, we conducted a double-blind, randomized, placebo-controlled crossover trial in 18 adults with DSM-5 SAD and compared the effects between intravenous ketamine (0.5 mg/kg over 40 min) and placebo (normal saline) on social phobia symptoms. Ketamine and placebo infusions were administered in a random order with a 28-day washout period between infusions. Ratings of anxiety were assessed 3-h post-infusion and followed for 14 days. We used linear mixed models to assess the impact of ketamine and placebo on anxiety symptoms. Outcomes were blinded ratings on the Liebowitz Social Anxiety Scale (LSAS) and self-reported anxiety on a visual analog scale (VAS-Anxiety). We also used the Wilcoxon signed-rank test to compare the proportion of treatment responders. Based on prior studies, we defined response as a greater than 35% LSAS reduction and 50% VAS-Anxiety reduction. We found ketamine resulted in a significantly greater reduction in anxiety relative to placebo on the LSAS (Time × Treatment: F 9,115 =2.6, p=0.01) but not the VAS-Anxiety (Time × Treatment: F 10,141 =0.4, p=0.95). Participants were significantly more likely to exhibit a treatment response after ketamine infusion relative to placebo in the first 2 weeks following infusion measured on the LSAS (33.33% response ketamine vs 0% response placebo, Wilcoxon signed-rank test z=2.24, p=0.025) and VAS (88.89% response ketamine vs 52.94% response placebo, Wilcoxon signed-rank test z=2.12, p=0.034). In conclusion, this proof-of-concept trial provides initial evidence that ketamine may be effective in reducing anxiety.

  14. 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

  15. 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

  16. The effectiveness of topical colloidal silver in recalcitrant chronic rhinosinusitis: a randomized crossover control trial.

    Science.gov (United States)

    Scott, John R; Krishnan, Rohin; Rotenberg, Brian W; Sowerby, Leigh J

    2017-11-25

    Recalcitrant chronic rhinosinusitis without polyposis (CRSsP) is a challenging condition to manage as traditional medical therapies and surgery fail to provide satisfactory clinical improvements. Colloidal silver (CS), a widely used naturopathic agent, has recently shown anti-biofilm properties both in vitro and within a rhinosinusitis animal model. To date, no trials involving humans have been published in world literature. The purpose of this study was to assess the efficacy of CS as a topical nasal spray in patients with refractory CRSsP. A prospective cohort study was conducted using a convenience sample of 20 randomized patients with crossover methodology, comparing nasal sprays with CS versus saline. Patients sprayed twice daily for six weeks with the first intervention and then switched to the second for the next six weeks, with measurements made at baseline and each time point. Primary outcomes were changes in SNOT-22 and Lund-Kennedy (LK) endoscopic scores. All analysis was non-parametric and was conducted using STATA 14. Twenty-two patients were enrolled in the study with 20 completing the entire protocol. Mean 6-week change in SNOT-22 scores were -2.8 and 1.0 for saline and CS, respectively (p = 0.373). Similarly, mean 6-week change in LK scores were -1.4 and -1.1 for saline and CS, respectively (p = 0.794). Significant period effects were observed with the SNOT-22 score between the randomized groups. No participants experienced negative health effects directly attributable to the administration of intranasal CS. Commercially available CS nasal spray did not demonstrate any meaningful subjective or objective improvements in patients with recalcitrant CRSsP. NCT02403479 . Registered on March 1, 2015.

  17. 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

  18. 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

    2018-02-01

    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.

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

    Science.gov (United States)

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

    2015-06-17

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

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

    DEFF Research Database (Denmark)

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

    2011-01-01

    of this study was to test the analgesic effect of levetiracetam in painful polyneuropathy. METHODS: This was a randomized, double-blind, placebo-controlled, cross-over trial with levetiracetam 3000mg/day versus placebo (6-week treatment periods). Patients with diagnosed polyneuropathy and symptoms for more than......-three patients were screened for participation and 39 patients entered the study. Thirty-five patients were included in the data analysis. There were no differences in the ratings of pain relief (levetiracetam 2.29 versus placebo 2.28, p=0.979), total pain intensity (levetiracetam 5.5 versus placebo 5.3, p=0......Levetiracetam is an anticonvulsant which is assumed to act by modulating neurotransmitter release via binding to the vesicle protein SV2A. This could have an impact on signaling in the nociceptive system, and a pilot study indicated relief of neuropathic pain with levetiracetam. OBJECTIVES: The aim...

  1. Metabolic and hormonal effects of caffeine: randomized, double-blind, placebo-controlled crossover trial.

    Science.gov (United States)

    MacKenzie, Todd; Comi, Richard; Sluss, Patrick; Keisari, Ronit; Manwar, Simone; Kim, Janice; Larson, Robin; Baron, John A

    2007-12-01

    In short-term studies, caffeine has been shown to increase insulin levels, reduce insulin sensitivity, and increase cortisol levels. However, epidemiological studies have indicated that long-term consumption of beverages containing caffeine such as coffee and green tea is associated with a reduced risk of type 2 diabetes mellitus. There is a paucity of randomized studies addressing the metabolic and hormonal effects of consuming caffeine over periods of more than 1 day. We evaluated the effect of oral intake of 200 mg of caffeine taken twice a day for 7 days on glucose metabolism, as well as on serum cortisol, dehydroepiandrosterone (DHEA), and androstenedione, and on nighttime salivary melatonin. A double-blind, randomized, placebo-controlled crossover study with periods of 7 days and washouts of 5 days comparing caffeine with placebo capsules was conducted. Participants were 16 healthy adults aged 18 to 22 years with a history of caffeine consumption. Blood samples from each subject were assayed for glucose, insulin, serum cortisol, DHEA, and androstenedione on the eighth day of each period after an overnight fast. Nighttime salivary melatonin was also measured. Insulin levels were significantly higher (by 1.80 microU/mL; 95% confidence interval, 0.33-3.28) after caffeine intake than after placebo. The homeostasis model assessment index of insulin sensitivity was reduced by 35% (95% confidence interval, 7%-62%) by caffeine. There were no differences in glucose, DHEA, androstenedione, and melatonin between treatment periods. This study provides evidence that daily caffeine intake reduces insulin sensitivity; the effect persists for at least a week and is evident up to 12 hours after administration.

  2. 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.

  3. Self-Administered Computer Therapy for Apraxia of Speech: Two-Period Randomized Control Trial With Crossover.

    Science.gov (United States)

    Varley, Rosemary; Cowell, Patricia E; Dyson, Lucy; Inglis, Lesley; Roper, Abigail; Whiteside, Sandra P

    2016-03-01

    There is currently little evidence on effective interventions for poststroke apraxia of speech. We report outcomes of a trial of self-administered computer therapy for apraxia of speech. Effects of speech intervention on naming and repetition of treated and untreated words were compared with those of a visuospatial sham program. The study used a parallel-group, 2-period, crossover design, with participants receiving 2 interventions. Fifty participants with chronic and stable apraxia of speech were randomly allocated to 1 of 2 order conditions: speech-first condition versus sham-first condition. Period 1 design was equivalent to a randomized controlled trial. We report results for this period and profile the effect of the period 2 crossover. Period 1 results revealed significant improvement in naming and repetition only in the speech-first group. The sham-first group displayed improvement in speech production after speech intervention in period 2. Significant improvement of treated words was found in both naming and repetition, with little generalization to structurally similar and dissimilar untreated words. Speech gains were largely maintained after withdrawal of intervention. There was a significant relationship between treatment dose and response. However, average self-administered dose was modest for both groups. Future software design would benefit from incorporation of social and gaming components to boost motivation. Single-word production can be improved in chronic apraxia of speech with behavioral intervention. Self-administered computerized therapy is a promising method for delivering high-intensity speech/language rehabilitation. URL: http://orcid.org/0000-0002-1278-0601. Unique identifier: ISRCTN88245643. © 2016 American Heart Association, Inc.

  4. Magnet therapy for the relief of pain and inflammation in rheumatoid arthritis (CAMBRA: A randomised placebo-controlled crossover trial

    Directory of Open Access Journals (Sweden)

    Richmond Stewart J

    2008-09-01

    Full Text Available Abstract Background Rheumatoid arthritis is a common inflammatory autoimmune disease. Although disease activity may be managed effectively with prescription drugs, unproven treatments such as magnet therapy are sometimes used as an adjunct for pain control. Therapeutic devices incorporating permanent magnets are widely available and easy to use. Magnets may also be perceived as a more natural and less harmful alternative to analgesic compounds. Of interest to health service researchers is the possibility that magnet therapy might help to reduce the economic burden of managing chronic musculoskeletal disorders. Magnets are extremely cheap to manufacture and prolonged treatment involves a single cost. Despite this, good quality scientific evidence concerning the safety, effectiveness and cost-effectiveness of magnet therapy is scarce. The primary aim of the CAMBRA trial is to investigate the effectiveness of magnet therapy for relieving pain and inflammation in rheumatoid arthritis. Methods/Design The CAMBRA trial employs a randomised double-blind placebo-controlled crossover design. Participant will each wear four devices: a commercially available magnetic wrist strap; an attenuated wrist strap; a demagnetised wrist strap; and a copper bracelet. Device will be allocated in a randomised sequence and each worn for five weeks. The four treatment phases will be separated by wash out periods lasting one week. Both participants and researchers will be blind, as far as feasible, to the allocation of experimental and control devices. In total 69 participants will be recruited from general practices within the UK. Eligible patients will have a verified diagnosis of rheumatoid arthritis that is being managed using drugs, and will be experiencing chronic pain. Outcomes measured will include pain, inflammation, disease activity, physical function, medication use, affect, and health related costs. Data will be collected using questionnaires, diaries, manual

  5. 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

  6. Melatonin versus Placebo in Children with Autism Spectrum Conditions and Severe Sleep Problems Not Amenable to Behaviour Management Strategies: A Randomised Controlled Crossover Trial

    Science.gov (United States)

    Wright, Barry; Sims, David; Smart, Siobhan; Alwazeer, Ahmed; Alderson-Day, Ben; Allgar, Victoria; Whitton, Clare; Tomlinson, Heather; Bennett, Sophie; Jardine, Jenni; McCaffrey, Nicola; Leyland, Charlotte; Jakeman, Christine; Miles, Jeremy

    2011-01-01

    Twenty-two children with autism spectrum disorders who had not responded to supported behaviour management strategies for severe dysomnias entered a double blind, randomised, controlled crossover trial involving 3 months of placebo versus 3 months of melatonin to a maximum dose of 10 mg. 17 children completed the study. There were no significant…

  7. Cashew consumption reduces total and LDL cholesterol: a randomized, crossover, controlled-feeding trial.

    Science.gov (United States)

    Mah, Eunice; Schulz, Jacqueline A; Kaden, Valerie N; Lawless, Andrea L; Rotor, Jose; Mantilla, Libertie B; Liska, DeAnn J

    2017-05-01

    Background: Cashews are the third most-consumed tree nut in the United States and are abundant with monounsaturated fatty acids and polyunsaturated fatty acids, which are associated with reduced cardiovascular disease risk. Although a qualified Food and Drug Administration health claim exists for nuts and heart health, cashews have been exempt from its use because cashews exceed the disqualifying amount of saturated fatty acids. Approximately one-third of the saturated fat in cashews is stearic acid, which is relatively neutral on blood lipids, thereby suggesting that cashews could have effects that are similar to those of other nuts. However, clinical data on cashews and blood lipids have been limited. Objective: We investigated the effect of reasonable intakes of cashews on serum lipids in adults with or at risk of high LDL cholesterol. Design: In a randomized, crossover, isocaloric, controlled-feeding study, 51 men and women (aged 21-73 y) with a median LDL-cholesterol concentration of 159 mg/dL (95% CI: 146, 165 mg/dL) at screening consumed typical American diets with cashews (28-64 g/d; 50% of kilocalories from carbohydrate, 18% of kilocalories from protein, and 32% of kilocalories from total fat) or potato chips (control; 54% of kilocalories from carbohydrate, 18% of kilocalories from protein, and 29% of kilocalories from total fat) for 28 d with a ≥2-wk washout period. Results: Consumption of the cashew diet resulted in a significantly greater median change from baseline (compared with the control, all P cholesterol [-3.9% (95% CI: -9.3%, 1.7%) compared with 0.8% (95% CI: -1.5%, 4.5%), respectively], LDL cholesterol [-4.8% (95% CI: -12.6%, 3.1%) compared with 1.2% (95% CI: -2.3%, 7.8%), respectively], non-HDL cholesterol [-5.3% (95% CI: -8.6%, 2.1%) compared with 1.7% (95% CI: -0.9%, 5.6%), respectively], and the total-cholesterol:HDL-cholesterol ratio [-0.0% (95% CI: -4.3%, 4.8%) compared with 3.4% (95% CI: 0.6%, 5.2%), respectively]. There were no

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

    Science.gov (United States)

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

    2017-05-01

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

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Science.gov (United States)

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

    2013-07-01

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

  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. 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.

  13. Antispasmodic/analgesic associations in primary dysmenorrhea double-blind crossover placebo-controlled clinical trial.

    Science.gov (United States)

    de los Santos, A R; Zmijanovich, R; Pérez Macri, S; Martí, M L; Di Girolamo, G

    2001-01-01

    We studied 125 patients with primary dysmenorrhea in a prospective randomized double-blind crossover study. After an admission pretreatment period without medication, the patients completed three consecutive randomized treatment phases with lysine clonixinate 125 mg plus propinox 10 mg or paracetamol 500 mg plus hyoscine N-butylbromide 10 mg or placebo, according to a fixed-dose schedule of 1 tablet every 6 h, 3 days before onset of menses and for 5 days thereafter. Changes in menstrual pain intensity and duration, amount of bleeding measured according to the number of daily pads used and concomitant symptoms were assessed on the fifth day of each cycle. Every night, the patients recorded the average intensity of menstrual pain during the first 4 days of menstruation in a diary The follow-up visit carried out at day 5 showed significant reduction in pain intensity with both active treatments vs. the other two phases: baseline: 2.72 +/- 0.61; placebo: 1.85 +/- 0.87; lysine clonixinate plus propinox 1.36 +/- 0.81, and paracetamol plus hyosine N-butylbromide: 1.45 +/- 0.87. The patients' diaries showed increasingly lower pain intensities starting from day 1 with the three treatments. Active treatments revealed significantly higher analgesic efficacy from the outset compared with baseline and placebo; however, only the lysine clonixinate plus propinox combination reached a statistically significant difference by days 3 and 4. No changes in duration or intensity of menstrual bleeding or in the incidence of adverse effects were observed during the four study periods.

  14. Effects of tetrahydrocannabinol on balance and gait in patients with dementia: A randomised controlled crossover trial.

    Science.gov (United States)

    van den Elsen, Geke Ah; Tobben, Lieke; Ahmed, Amir Ia; Verkes, Robbert Jan; Kramers, Cornelis; Marijnissen, Radboud M; Olde Rikkert, Marcel Gm; van der Marck, Marjolein A

    2017-02-01

    Oral tetrahydrocannabinol (THC) is currently studied for its possible efficacy on dementia-related neuropsychiatric symptoms (NPS), but might lead to increased risk of falling. This was a randomised, double-blind, crossover study to evaluate the effects of THC on mobility in dementia patients. Eighteen community-dwelling patients ( M age =77 years) received 1.5 mg of oral THC twice daily and placebo, in random order, for three days, separated by a four-day washout. Balance and gait were assessed using SwayStar TM and GAITRite TM within two hours after administration, in two consecutive intervention periods, under the following conditions: standing with eyes open (EO) and eyes closed (EC), preferred speed walking with and without a cognitive dual task. THC significantly increased sway during standing EC (roll angle 0.32[±0.6]°, p=0.05; pitch angle 1.04[±1.5]°, p=0.009; pitch velocity 1.96[±3.3]°/s, p=0.02), but not during standing EO. During preferred speed walking, THC increased stride length (4.3[±5.4] cm, p=0.005) and trunk sway (pitch angle 1.18[±1.6]°, p=0.005). No effects were observed during dual task walking. No differences in the number and type of adverse events were found, and no falls occurred after administration of THC. This study showed that 3 mg of THC per day has a benign adverse event profile regarding mobility and was well tolerated by community-dwelling dementia patients.

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

    Science.gov (United States)

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

    2014-09-01

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

  16. 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

  17. Meal sequence and glucose excursion, gastric emptying and incretin secretion in type 2 diabetes: a randomised, controlled crossover, exploratory trial.

    Science.gov (United States)

    Kuwata, Hitoshi; Iwasaki, Masahiro; Shimizu, Shinobu; Minami, Kohtaro; Maeda, Haruyo; Seino, Susumu; Nakada, Koji; Nosaka, Chihiro; Murotani, Kenta; Kurose, Takeshi; Seino, Yutaka; Yabe, Daisuke

    2016-03-01

    Investigation of dietary therapy for diabetes has focused on meal size and composition; examination of the effects of meal sequence on postprandial glucose management is limited. The effects of fish or meat before rice on postprandial glucose excursion, gastric emptying and incretin secretions were investigated. The experiment was a single centre, randomised controlled crossover, exploratory trial conducted in an outpatient ward of a private hospital in Osaka, Japan. Patients with type 2 diabetes (n = 12) and healthy volunteers (n = 10), with age 30-75 years, HbA1c 9.0% (75 mmol/mol) or less, and BMI 35 kg/m(2) or less, were randomised evenly to two groups by use of stratified randomisation, and subjected to meal sequence tests on three separate mornings; days 1 and 2, rice before fish (RF) or fish before rice (FR) in a crossover fashion; and day 3, meat before rice (MR). Pre- and postprandial levels of glucose, insulin, C-peptide and glucagon as well as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide were evaluated. Gastric emptying rate was determined by (13)C-acetate breath test involving measurement of (13)CO2 in breath samples collected before and after ingestion of rice steamed with (13)C-labelled sodium acetate. Participants, people doing measurements or examinations, and people assessing the outcomes were not blinded to group assignment. FR and MR in comparison with RF ameliorated postprandial glucose excursion (AUC-15-240 min-glucose: type 2 diabetes, FR 2,326.6 ± 114.7 mmol/l × min, MR 2,257.0 ± 82.3 mmol/l × min, RF 2,475.6 ± 87.2 mmol/l × min [p Japan Society for Promotion of Science, Japan Association for Diabetes Education and Care, and Japan Vascular Disease Research Foundation.

  18. Differential benefits of amoxicillin-metronidazole in different phases of periodontal therapy in a randomized controlled crossover clinical trial.

    Science.gov (United States)

    Mombelli, Andrea; Almaghlouth, Adnan; Cionca, Norbert; Courvoisier, Delphine S; Giannopoulou, Catherine

    2015-03-01

    The specific advantage of administering systemic antibiotics during initial, non-surgical therapy or in the context of periodontal surgery is unclear. This study assesses the differential outcomes of periodontal therapy supplemented with amoxicillin-metronidazole during either the non-surgical or the surgical treatment phase. This is a single-center, randomized placebo-controlled crossover clinical trial with a 1-year follow-up. Eighty participants with Aggregatibacter actinomycetemcomitans-associated moderate to advanced periodontitis were randomized into two treatment groups: group A, antibiotics (500 mg metronidazole plus 375 mg amoxicillin three times per day for 7 days) during the first, non-surgical phase of periodontal therapy (T1) and placebo during the second, surgical phase (T2); and group B, placebo during T1 and antibiotics during T2. The number of sites with probing depth (PD) >4 mm and bleeding on probing (BOP) per patient was the primary outcome. A total of 11,212 sites were clinically monitored on 1,870 teeth. T1 with antibiotics decreased the number of sites with PD >4 mm and BOP per patient significantly more than without (group A: from 34.5 to 5.7, 84%; group B: from 28.7 to 8.7, 70%; P antibiotics, but only eight treated with placebo, achieved a 10-fold reduction of diseased sites (P = 0.007). Consequently, fewer patients of group A needed additional therapy, the mean number of surgical interventions was lower, and treatment time in T2 was shorter. Six months after T2, the mean number of residual pockets (group A: 2.8 ± 5.2; group B: 2.2 ± 5.0) was not significantly different and was sustained over 12 months in both groups. Giving the antibiotics during T1 or T2 yielded similar long-term outcomes, but antibiotics in T1 resolved the disease quicker and thus reduced the need for additional surgical intervention.

  19. Immediate effects of kinesiotaping on quadriceps muscle strength: a single-blind, placebo-controlled crossover trial.

    Science.gov (United States)

    Vercelli, Stefano; Sartorio, Francesco; Foti, Calogero; Colletto, Lorenzo; Virton, Domenico; Ronconi, Gianpaolo; Ferriero, Giorgio

    2012-07-01

    To investigate the immediate effects on maximal muscle strength of kinesiotaping (KT) applied to the dominant quadriceps of healthy subjects. Single-blind, placebo-controlled crossover trial. "Salvatore Maugeri" Foundation. With ethical approval and informed consent, a convenience sample of 36 healthy volunteers were recruited. Two subjects did not complete the sessions and were excluded from the analysis. Subjects were tested across 3 different sessions, randomly receiving 2 experimental KT conditions applied with the aim of enhancing and inhibiting muscle strength and a sham KT application. Quadriceps muscle strength was measured by means of an isokinetic maximal test performed at 60 and 180 degrees per second. Two secondary outcome measures were performed: the single-leg triple hop for distance to measure limb performance and the Global Rating of Change Scale (GRCS) to calculate agreement between KT application and subjective perception of strength. Compared with baseline, none of the 3 taping conditions showed a significant change in muscle strength and performance (all P > 0.05). Effect size was very low under all conditions (≤0.08). Very few subjects showed an individual change greater than the minimal detectable change. Global Rating of Change Scale scores demonstrated low to moderate agreement with the type of KT applied, but some placebo effects were reported independently of condition. Our findings indicated no significant effect in the maximal quadriceps strength immediately after the application of inhibition, facilitation, or sham KT. These results do not support the use of KT applied in this way to change maximal muscle strength in healthy people.

  20. Open-label trial and randomized, double-blind, placebo-controlled, crossover trial of hydrogen-enriched water for mitochondrial and inflammatory myopathies

    Directory of Open Access Journals (Sweden)

    Ito Mikako

    2011-10-01

    Full Text Available Abstract Background Molecular hydrogen has prominent effects on more than 30 animal models especially of oxidative stress-mediated diseases and inflammatory diseases. In addition, hydrogen effects on humans have been reported in diabetes mellitus type 2, hemodialysis, metabolic syndrome, radiotherapy for liver cancer, and brain stem infarction. Hydrogen effects are ascribed to specific radical-scavenging activities that eliminate hydroxyl radical and peroxynitrite, and also to signal-modulating activities, but the detailed molecular mechanisms still remain elusive. Hydrogen is a safe molecule that is largely produced by intestinal bacteria in rodents and humans, and no adverse effects have been documented. Methods We performed open-label trial of drinking 1.0 liter per day of hydrogen-enriched water for 12 weeks in five patients with progressive muscular dystrophy (PMD, four patients with polymyositis/dermatomyositis (PM/DM, and five patients with mitochondrial myopathies (MM, and measured 18 serum parameters as well as urinary 8-isoprostane every 4 weeks. We next conducted randomized, double-blind, placebo-controlled, crossover trial of 0.5 liter per day of hydrogen-enriched water or placebo water for 8 weeks in 10 patients with DM and 12 patients with MM, and measured 18 serum parameters every 4 weeks. Results In the open-label trial, no objective improvement or worsening of clinical symptoms was observed. We, however, observed significant effects in lactate-to-pyruvate ratios in PMD and MM, fasting blood glucose in PMD, serum matrix metalloproteinase-3 (MMP3 in PM/DM, and serum triglycerides in PM/DM. In the double-blind trial, no objective clinical effects were observed, but a significant improvement was detected in lactate in MM. Lactate-to-pyruvate ratios in MM and MMP3 in DM also exhibited favorable responses but without statistical significance. No adverse effect was observed in either trial except for hypoglycemic episodes in an insulin

  1. 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

  2. Effects of Milnacipran on Neurocognition, Pain, and Fatigue in Fibromyalgia: A 13-Week, Randomized, Placebo-Controlled, Crossover Trial

    Science.gov (United States)

    Kim, Jeong Lan; Rele, Shilpa; Marks, David M.; Masand, Prakash S.; Yerramsetty, Pallavi; Millet, Robert A.; Keefe, Richard S.

    2013-01-01

    Objective: To investigate whether milnacipran is safe and effective in improving cognitive function in patients with fibromyalgia. Method: Patients were randomly assigned to receive milnacipran or placebo for 6 weeks, followed by a 1-week washout and then crossover to the other arm for another 6 weeks. The overall trial lasted 13 weeks and was conducted between July 2011 and May 2013. Assessments were performed at each visit. Neurocognition was measured by the Brief Assessment of Cognition (BAC) and MATRICS. Pain was assessed by the visual analog scale (VAS) for pain. Global assessment of fibromyalgia symptoms was measured by the Fibromyalgia Impact Questionnaire (FIQ) and tender point examination. Depression was assessed by the Beck Depression Inventory (BDI). Fatigue was assessed by the Fatigue Severity Scale. Functional outcome was evaluated by the Health Assessment Questionnaire. The Clinical Global Impressions–Severity of Illness (CGI-S) and Improvement (CGI-I) scales and the Patients Clinical Global Impression of Change were used to measure the global impression of severity and improvement. Results: 26 subjects were screened, and 20 subjects completed the trial. The change in verbal memory (P = .001) and the composite T score (P = .044) of the BAC and the change in the attention-vigilance domain T score (P = .042) were significantly improved, but there were no differences between the drug and placebo groups. The changes in the CGI-S scores were not significant, but the changes in the Clinical Impression-Improvement (CGI-I) scores showed worsening in the placebo group at week 1 (P = .032), week 2 (P = .024), week 4 (P = .024), and week 6 (P = .60) compared to baseline. The change in FIQ scores was not significant. Conclusions: Milnacipran may have a potential role in the improvement of pain, disability, and mood. The effect of milnacipran on cognition in fibromyalgia needs further research. Trial Registration: ClinicalTrials.gov identifier: NCT01829243 PMID

  3. An Herbal Drug, Gongjin-dan, Ameliorates Acute Fatigue Caused by Short-Term Sleep-Deprivation: A Randomized, Double-Blinded, Placebo-Controlled, Crossover Clinical Trial

    Directory of Open Access Journals (Sweden)

    Mi Ju Son

    2018-05-01

    Full Text Available Introduction:Gongjin-dan (GJD is an herbal drug commonly used in Korea and China to combat fatigue, but there are only few clinical studies on its effectiveness and experimental studies on its mechanism of action, and no randomized controlled trial of GJD on the efficacy and mechanism of action has been reported. Here, we performed an exploratory study to evaluate both questions regarding GJD use in humans.Methods: A randomized, double-blinded, placebo-controlled, crossover clinical trial was conducted in the Republic of Korea. Healthy male participants were recruited and randomly allocated to groups receiving GJD-placebo or placebo-GJD in sequence. Fatigue was artificially induced by sleep deprivation for 2 nights. The primary outcome was a change in serum cortisol level; levels of biomarkers for stress hormones as well as oxidative stress and immunologic factors were also assessed, and questionnaires on fatigue and sleep quality were conducted.Results: Twelve and 11 participants were assigned to the GJD-placebo and placebo-GJD groups, respectively. Of all 23 participants, depending on crossover design, we analyzed a total of 20 participants for GJD, and 21 for placebo. An increase in serum cortisol appeared to be attenuated by GJD administration (p = 0.25, but the effect was not statistically significant; a similar pattern was observed in salivary cortisol levels (p = 0.14. Overall, GJD showed a tendency to reduce fatigue according to the Brief Fatigue Inventory (BFI, p = 0.07 and the Fatigue Severity Scale (FSS, p = 0.13 questionnaires. BFI and FSS scores in the first stage (before the crossover, however, were significantly improved (BFI, p = 0.02; FSS, p = 0.05 after GJD treatment (relative to placebo. GJD also seemed to improve sleep quality as assessed by the Leeds Sleep Evaluation Questionnaire (p = 0.06, with a significant improvement specifically in the condition “Getting To Sleep” (p = 0.02. Five participants experienced minor

  4. An Herbal Drug, Gongjin-dan, Ameliorates Acute Fatigue Caused by Short-Term Sleep-Deprivation: A Randomized, Double-Blinded, Placebo-Controlled, Crossover Clinical Trial.

    Science.gov (United States)

    Son, Mi Ju; Im, Hwi-Jin; Ku, Boncho; Lee, Jun-Hwan; Jung, So Young; Kim, Young-Eun; Lee, Sung Bae; Kim, Jun Young; Son, Chang-Gue

    2018-01-01

    Introduction: Gongjin-dan (GJD) is an herbal drug commonly used in Korea and China to combat fatigue, but there are only few clinical studies on its effectiveness and experimental studies on its mechanism of action, and no randomized controlled trial of GJD on the efficacy and mechanism of action has been reported. Here, we performed an exploratory study to evaluate both questions regarding GJD use in humans. Methods: A randomized, double-blinded, placebo-controlled, crossover clinical trial was conducted in the Republic of Korea. Healthy male participants were recruited and randomly allocated to groups receiving GJD-placebo or placebo-GJD in sequence. Fatigue was artificially induced by sleep deprivation for 2 nights. The primary outcome was a change in serum cortisol level; levels of biomarkers for stress hormones as well as oxidative stress and immunologic factors were also assessed, and questionnaires on fatigue and sleep quality were conducted. Results: Twelve and 11 participants were assigned to the GJD-placebo and placebo-GJD groups, respectively. Of all 23 participants, depending on crossover design, we analyzed a total of 20 participants for GJD, and 21 for placebo. An increase in serum cortisol appeared to be attenuated by GJD administration ( p = 0.25), but the effect was not statistically significant; a similar pattern was observed in salivary cortisol levels ( p = 0.14). Overall, GJD showed a tendency to reduce fatigue according to the Brief Fatigue Inventory (BFI, p = 0.07) and the Fatigue Severity Scale (FSS, p = 0.13) questionnaires. BFI and FSS scores in the first stage (before the crossover), however, were significantly improved (BFI, p = 0.02; FSS, p = 0.05) after GJD treatment (relative to placebo). GJD also seemed to improve sleep quality as assessed by the Leeds Sleep Evaluation Questionnaire ( p = 0.06), with a significant improvement specifically in the condition "Getting To Sleep" ( p = 0.02). Five participants experienced minor adverse

  5. Efficacy and hypnotic effects of melatonin in shift-work nurses: double-blind, placebo-controlled crossover trial

    Directory of Open Access Journals (Sweden)

    Pouryaghoub Gholamreza

    2008-10-01

    Full Text Available Abstract Background Night work is associated with disturbed sleep and wakefulness, particularly in relation to the night shift. Circadian rhythm sleep disorders are characterized by complaints of insomnia and excessive daytime sleepiness that are primarily due to alterations in the internal circadian timing system or a misalignment between the timing of sleep and the 24-h social and physical environment. Methods We evaluated the effect of oral intake of 5 mg melatonin taken 30 minutes before night time sleep on insomnia parameters as well as subjective sleep onset latency, number of awakenings, and duration of sleep. A double-blind, randomized, placebo-controlled crossover study with periods of 1 night and washouts of 4 days comparing melatonin with placebo tablets was conducted. We tried to improve night-time sleep during recovery from night work. Participants were 86 shift-worker nurses aged 24 to 46 years. Each participant completed a questionnaire immediately after awakening. Results Sleep onset latency was significantly reduced while subjects were taking melatonin as compared with both placebo and baseline. There was no evidence that melatonin altered total sleep time (as compared with baseline total sleep time. No adverse effects of melatonin were noted during the treatment period. Conclusion Melatonin may be an effective treatment for shift workers with difficulty falling asleep.

  6. A randomized, double-blind, placebo-controlled, crossover trial of mifepristone in Gulf War veterans with chronic multisymptom illness.

    Science.gov (United States)

    Golier, Julia A; Caramanica, Kimberly; Michaelides, Andreas C; Makotkine, Iouri; Schmeidler, James; Harvey, Philip D; Yehuda, Rachel

    2016-02-01

    No pharmacological treatments have been demonstrated to effectively treat chronic multisymptom illness (CMI) in Gulf War veterans (GWV). This study assessed the effect of the glucocorticoid receptor antagonist mifepristone in GWV with CMI. A randomized, double-blind, cross-over trial of mifepristone, with two six-week treatment phases separated by a one-month washout period, was conducted at a Veterans Affairs (VA) hospital between 2008 and 2011. Participants were randomized to receive either 200mg of mifepristone per day or matched placebo first. The primary clinical outcome measure was change in self-reported physical health. Neurocognitive functioning and self-reported measures of depression, PTSD, and fatigue were secondary outcomes. Sixty-five participants enrolled, of whom 36 were randomized and 32 (mean age, 49.1 (7.2) years) completed the study. Physical and mental health status and neurocognitive functioning were poor at baseline. Mifepristone treatment was not associated with improvement in self-reported physical health (p=0.838) or in other self-reported measures of mental health. Mifepristone treatment was significantly associated with improvements in verbal learning (p=0.008, d=0.508), in the absence of improvement in other cognitive measures (working memory (p=0.914), visual learning (p=0.643) and a global composite measure (p=0.937). Baseline morning cortisol levels and lysozyme IC50-DEX, a measure of peripheral glucocorticoid sensitivity, displayed a significant relationship with endpoint verbal learning scores (p=0.012 and p=0.007, respectively). The magnitude of cortisol change during treatment mediated the improvement in verbal learning. This study was negative for the primary and secondary clinical outcomes. However, the data suggest a moderate dose of mifepristone may have circumscribed cognitive-enhancing effects in CMI. Further study is warranted to determine whether and through which mechanisms mifepristone treatment can yield clinically

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

    Science.gov (United States)

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

    2013-11-13

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

  8. A human model of inflammatory cardio-metabolic dysfunction; a double blind placebo-controlled crossover trial

    Directory of Open Access Journals (Sweden)

    Mehta Nehal N

    2012-06-01

    Full Text Available Abstract Background Chronic inflammation may contribute to insulin resistance (IR, metabolic syndrome and atherosclerosis although evidence of causality is lacking in humans. We hypothesized that very low-dose experimental endotoxemia would induce adipose tissue inflammation and systemic IR during a low-grade but asymptomatic inflammatory response and thus provide an experimental model for future tests of pharmacologic and genomic modulation of cardio-metabolic traits in humans. Methods Ten healthy, human volunteers (50% male, 90% Caucasian, mean age 22.7 ± 3.8 were randomized in a double-masked, placebo-controlled, crossover study to separate 36-hour inpatient visits (placebo versus intravenous-LPS 0.6 ng/kg. We measured clinical symptoms via the McGill pain questionnaire and serial vital signs. Plasma and serum were collected for measurement of cytokines, C-reactive protein, insulin and glucose, serial whole blood & subcutaneous adipose tissue mRNA expression were measured by real-time PCR. HOMA-IR, a well-validated measure of IR was calculated to estimate insulin resistance, and frequently sampled intravenous glucose tolerance testing (FSIGTT was performed to confirm an insulin resistant state. We performed ANOVA and within subject ANOVA to understand the differences in cytokines, adipose tissue inflammation and IR before and after LPS or placebo. Results There was no significant difference between placebo and LPS in clinical responses of symptom scores, body temperature or heart rate. However, low-dose endotoxemia induced a rapid and transient 25-fold induction of plasma TNF-alpha and 100-fold increase in plasma IL-6 (Figure 1B (p p p = 0.01 increased with MCP-1 (peak 10-fold, F = 5.6, p p p p  Conclusions We present a low dose human endotoxemia model of inflammation which induces adipose tissue inflammation and systemic insulin resistance in the absence of overt clinical response. Such a model has the potential

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

    Science.gov (United States)

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

    2018-05-01

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

  10. An Intervention with Mineral Water Decreases Cardiometabolic Risk Biomarkers. A Crossover, Randomised, Controlled Trial with Two Mineral Waters in Moderately Hypercholesterolaemic Adults

    Directory of Open Access Journals (Sweden)

    Laura Toxqui

    2016-06-01

    Full Text Available Water intake is essential for health maintenance and disease prevention. The effects of an intervention with two mineral waters, sodium-bicarbonated mineral water (BW or control mineral water low in mineral content (CW, on cardiometabolic risk biomarkers were studied. In a randomised-controlled crossover-trial, sixty-four moderately hypercholesterolaemic adults were randomly assigned to consume 1 L/day of either BW (sodium, 1 g/L; bicarbonate, 2 g/L or CW with the main meals for eight weeks, separated by an eight-week washout period. Blood lipids, lipid oxidation, glucose, insulin, aldosterone, urine pH, urinary electrolytes, blood pressure, body weight, fluid intake, energy, and nutrients from total diet and beverages were determined. Total cholesterol, LDL cholesterol, and glucose decreased (p < 0.01, oxidised LDL tended to decrease (p = 0.073, and apolipoprotein B increased during the intervention, without water type effect. Energy and carbohydrates from beverages decreased since soft drinks and fruit juice consumptions decreased throughout the trial. BW increased urinary pH (p = 0.006 and reduced calcium/creatinine excretion (p = 0.011. Urinary potassium/creatinine decreased with both waters. Consumption of 1 L/day of mineral water with the main meals reduces cardiometabolic risk biomarkers, likely to be attributed to a replacement of soft drinks by water. In addition, BW does not affect blood pressure and exerts a moderate alkalizing effect in the body.

  11. Effect of Keishibukuryogan on Endothelial Function in Patients with at Least One Component of the Diagnostic Criteria for Metabolic Syndrome: A Controlled Clinical Trial with Crossover Design

    Directory of Open Access Journals (Sweden)

    Yutaka Nagata

    2012-01-01

    Full Text Available We evaluated the effect of keishibukuryogan (KBG; Guizhi-Fuling-Wan, a traditional Japanese (Kampo formula, on endothelial function assessed by reactive hyperemia peripheral arterial tonometry (Endo-PAT2000 in patients with metabolic syndrome-related factors by controlled clinical trial with crossover design. Ninety-two patients were assigned to group A (first KBG-treatment period, then control period; each lasting 4 weeks, with about one-year interval or group B (first control, then KBG-treatment. In forty-nine (27, group A; 22, group B patients completing all tests, the mean value of the natural logarithmic-scaled reactive hyperemia index (L_RHI increased and those of serum nonesterified fatty acid (NEFA, malondialdehyde, and soluble vascular cell adhesion molecule 1 decreased significantly during the KBG-treatment period, but not during the control period, and 4-week changes of L_RHI, NEFA, and malondialdehyde between the 2 periods showed significance. These results suggest that KBG has beneficial effect on endothelial function in patients with metabolic syndrome-related factors.

  12. Economic Evaluation Alongside a Randomized Controlled Crossover Trial of Modified Group Cognitive–Behavioral Therapy for Anxiety Compared to Treatment-as-Usual in Adults With Asperger Syndrome

    Directory of Open Access Journals (Sweden)

    Brett Doble PhD

    2017-08-01

    Full Text Available Background: There is a growing interest in using group cognitive–behavioral therapy (CBT with people who have Asperger syndrome (AS and comorbid mental health problems. This study aims to assess the cost-effectiveness of modified group CBT for adults with AS experiencing co-occurring anxiety compared to treatment-as-usual. Methods: Economic evaluation alongside a pilot, multicenter, single-blind, randomized controlled crossover trial. Costs from the UK public sector (National Health Service and Social Services and societal perspectives, quality-adjusted life years (QALYs, incremental net (monetary benefit (INB, expected value of perfect information, expected value of sample information, expected net gain of sampling, and efficient sample size of a future trial are reported. Results: Over 48 weeks, from the societal perspective, CBT results in additional costs of £6,647, with only a 0.015 incremental gain in QALYs, leading to a negative INB estimate of £6,206 and a 23% probability of cost-effectiveness at a threshold of £30,000/QALY. Results from sensitivity analyses support the unlikely cost-effectiveness of CBT but indicate the potential for cost-effectiveness over longer time horizons. Eliminating decision uncertainty is valued at £277 million, and the efficient sample size for a future trial is estimated at 1,200 participants per arm. Limitations: Relatively small sample size and prevalence of missing data present challenges to the interpretation of the results. Conclusions: Current evidence from this small pilot study suggests that, on average, modified group CBT is not cost-effective. However, there is much decision uncertainty so such a conclusion could be wrong. A large, full-scale trial to reduce uncertainty would be an efficient investment for the UK health economy.

  13. 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.

  14. 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.

  15. Hyperbaric Oxygen Treatment of Chronic Refractory Radiation Proctitis: A Randomized and Controlled Double-Blind Crossover Trial With Long-Term Follow-Up

    International Nuclear Information System (INIS)

    Clarke, Richard E.; Tenorio, L. M. Catalina; Hussey, James R.; Toklu, Akin S.; Cone, D. Lindsie; Hinojosa, Jose G.; Desai, Samir P.; Dominguez Parra, Luis; Rodrigues, Sylvia D.; Long, Robert J.; Walker, Margaret B.

    2008-01-01

    Purpose: Cancer patients who undergo radiotherapy remain at life-long risk of radiation-induced injury to normal tissues. We conducted a randomized, controlled, double-blind crossover trial with long-term follow-up to evaluate the effectiveness of hyperbaric oxygen for refractory radiation proctitis. Methods and Materials: Patients with refractory radiation proctitis were randomized to hyperbaric oxygen at 2.0 atmospheres absolute (Group 1) or air at 1.1 atmospheres absolute (Group 2). The sham patients were subsequently crossed to Group 1. All patients were re-evaluated by an investigator who was unaware of the treatment allocation at 3 and 6 months and Years 1-5. The primary outcome measures were the late effects normal tissue-subjective, objective, management, analytic (SOMA-LENT) score and standardized clinical assessment. The secondary outcome was the change in quality of life. Results: Of 226 patients assessed, 150 were entered in the study and 120 were evaluable. After the initial allocation, the mean SOMA-LENT score improved in both groups. For Group 1, the mean was lower (p 0.0150) and the amount of improvement nearly twice as great (5.00 vs. 2.61, p = 0.0019). Similarly, Group 1 had a greater portion of responders per clinical assessment than did Group 2 (88.9% vs. 62.5%, respectively; p 0.0009). Significance improved when the data were analyzed from an intention to treat perspective (p = 0.0006). Group 1 had a better result in the quality of life bowel bother subscale. These differences were abolished after the crossover. Conclusion: Hyperbaric oxygen therapy significantly improved the healing responses in patients with refractory radiation proctitis, generating an absolute risk reduction of 32% (number needed to treat of 3) between the groups after the initial allocation. Other medical management requirements were discontinued, and advanced interventions were largely avoided. Enhanced bowel-specific quality of life resulted

  16. 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.

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

    Science.gov (United States)

    Park, Jimin; Woo, Jong Shin; Leem, Jungtae; Park, Jun Hyeong; Lee, Sanghoon; Chung, Hyemoon; Lee, Jung Myung; Kim, Jin-Bae; Kim, Woo-Shik; Kim, Kwon Sam; Kim, Weon

    2017-01-01

    Objective 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. Methods 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. Results 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). Conclusion EA may prevent IR-induced endothelial dysfunction via a COX-2 dependent mechanism. PMID:28591155

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

    Science.gov (United States)

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

    2018-02-01

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

  19. The use of portable video media vs standard verbal communication in the urological consent process: a multicentre, randomised controlled, crossover trial.

    Science.gov (United States)

    Winter, Matthew; Kam, Jonathan; Nalavenkata, Sunny; Hardy, Ellen; Handmer, Marcus; Ainsworth, Hannah; Lee, Wai Gin; Louie-Johnsun, Mark

    2016-11-01

    To determine if portable video media (PVM) improves patient's knowledge and satisfaction acquired during the consent process for cystoscopy and insertion of a ureteric stent compared to standard verbal communication (SVC), as informed consent is a crucial component of patient care and PVM is an emerging technology that may help improve the consent process. In this multi-centre randomised controlled crossover trial, patients requiring cystoscopy and stent insertion were recruited from two major teaching hospitals in Australia over a 15-month period (July 2014-December 2015). Patient information delivery was via PVM and SVC. The PVM consisted of an audio-visual presentation with cartoon animation presented on an iPad. Patient satisfaction was assessed using the validated Client Satisfaction Questionnaire 8 (CSQ-8; maximum score 32) and knowledge was tested using a true/false questionnaire (maximum score 28). Questionnaires were completed after first intervention and after crossover. Scores were analysed using the independent samples t-test and Wilcoxon signed-rank test for the crossover analysis. In all, 88 patients were recruited. A significant 3.1 point (15.5%) increase in understanding was demonstrable favouring the use of PVM (P < 0.001). There was no difference in patient satisfaction between the groups as judged by the CSQ-8. A significant 3.6 point (17.8%) increase in knowledge score was seen when the SVC group were crossed over to the PVM arm. A total of 80.7% of patients preferred PVM and 19.3% preferred SVC. Limitations include the lack of a validated questionnaire to test knowledge acquired from the interventions. This study demonstrates patients' preference towards PVM in the urological consent process of cystoscopy and ureteric stent insertion. PVM improves patient's understanding compared with SVC and is a more effective means of content delivery to patients in terms of overall preference and knowledge gained during the consent process. © 2016 The

  20. The effects of the DDS-1 strain of lactobacillus on symptomatic relief for lactose intolerance - a randomized, double-blind, placebo-controlled, crossover clinical trial.

    Science.gov (United States)

    Pakdaman, Michael N; Udani, Jay K; Molina, Jhanna Pamela; Shahani, Michael

    2016-05-20

    Lactose intolerance is a form of lactose maldigestion where individuals experience symptoms such as diarrhea, abdominal cramping, flatulence, vomiting and bowel sounds following lactose consumption. Lactobacillus acidophilus is a species of bacteria known for its sugar fermenting properties. Preclinical studies have found that Lactobacillus acidophilus supplementation may assist in breaking down lactose; however, no human clinical trials exist evaluating its efficacy in alleviating symptoms related to lactose intolerance. The aim of this randomized, double-blind, placebo-controlled, crossover study was to evaluate the effect of a proprietary strain of Lactobacillus acidophilus on relieving discomfort related to lactose intolerance. The study enrolled healthy volunteers between 18 and 75 years of age who complained of lactose intolerance. Screening visits included a lactose challenge visit to confirm eligibility based on a score of 10 or higher on subjective assessment of the following symptoms after lactose challenge: diarrhea, abdominal cramping, vomiting, audible bowel sounds, flatulence, and overall symptoms. Qualified subjects participated in a 2-arm crossover design, with each arm consisting of 4 weeks of intervention of either active or placebo product, with a 2-week washout period during crossover. The study product consisted of the DDS-1 strain of Lactobacillus acidophilus (Nebraska Cultures, Walnut Creek, California). The placebo was formulated from maltodextrin. Study participants were instructed to take the product once daily for 4 weeks. Data collected included subjective symptom scores related to lactose intolerance. Longitudinal comparison between the DDS-1 group and placebo group demonstrated statistically significant reductions in abdominal symptom scores during the 6-h Lactose Challenge at week 4 for diarrhea (p = 0.033), abdominal cramping (p = 0.012), vomiting (p = 0.0002), and overall symptom score (p = 0.037). No adverse

  1. The effect of Lactobacillus brevis KB290 against irritable bowel syndrome: a placebo-controlled double-blind crossover trial

    Directory of Open Access Journals (Sweden)

    Murakami Katsumi

    2012-08-01

    Full Text Available Abstract Background Irritable bowel syndrome (IBS is a functional disorder of the digestive tract that causes chronic abdominal symptoms. We evaluated the effects of Lactobacillus brevis KB290 (KB290, which has been demonstrated to be effective at improving bowel movements and the composition of intestinal microflora, on IBS symptoms. Methods We performed a placebo control double-blind cross matched trial. Thirty-five males and females (aged 6 years and above who had been diagnosed with IBS according to the Rome III criteria were divided into 2 groups, and after a 4-week pre-trial observation period, they were administered test capsules containing KB290 or placebo for 4 weeks (consumption period I. Then, the capsule administration was suspended for 4 weeks in both groups (washout period, before the opposite capsules were administered for a further 4 weeks (consumption period II. Fecal samples were collected on the first day of the pre-consumption observation period, the last day of consumption period I, the last day of the washout period, and the last day of consumption period II. In addition, the subjects’ IBS symptoms and quality of life (QOL and any adverse events that they experienced were evaluated. Results No significant difference in IBS symptoms was noted among the various periods. However, the mean QOL scores were improved during the test capsule consumption. The frequencies of watery and mushy feces were significantly lower in the test capsule consumption period than during the pre-consumption observation period, and the frequency of abdominal pain was significantly reduced in the test capsule consumption period compared with the other periods. The frequency of the genus Bifidobacterium was significantly higher, and that of the genus Clostridium was significantly lower, after the test capsule consumption than after the placebo consumption. The frequencies of the genera Lactobacillus, Bacteroides, and Enterococcus were also

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

    Directory of Open Access Journals (Sweden)

    Taku Miyagawa

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

  3. Lactobacillus salivarius WB21--containing tablets for the treatment of oral malodor: a double-blind, randomized, placebo-controlled crossover trial.

    Science.gov (United States)

    Suzuki, Nao; Yoneda, Masahiro; Tanabe, Kazunari; Fujimoto, Akie; Iha, Kosaku; Seno, Kei; Yamada, Kazuhiko; Iwamoto, Tomoyuki; Masuo, Yosuke; Hirofuji, Takao

    2014-04-01

    This study evaluated the effect of probiotic intervention using lactobacilli on oral malodor. We conducted a 14-day, double-blind, placebo-controlled, randomized crossover trial of tablets containing Lactobacillus salivarius WB21 (2.0 × 10(9) colony-forming units per day) or placebo taken orally by patients with oral malodor. Organoleptic test scores significantly decreased in both the probiotic and placebo periods compared with the respective baseline scores (P < .001 and P = .002), and no difference was detected between periods. In contrast, the concentration of volatile sulfur compounds (VSCs) (P = .019) and the average probing pocket depth (P = .001) decreased significantly in the probiotic period compared with the placebo period. Bacterial quantitative analysis found significantly lower levels of ubiquitous bacteria (P = .003) and Fusobacterium nucleatum (P = .020) in the probiotic period. These results indicated that daily oral consumption of tablets containing probiotic lactobacilli could help to control oral malodor and malodor-related factors. Copyright © 2014 Elsevier Inc. All rights reserved.

  4. Agave Inulin Supplementation Affects the Fecal Microbiota of Healthy Adults Participating in a Randomized, Double-Blind, Placebo-Controlled, Crossover Trial.

    Science.gov (United States)

    Holscher, Hannah D; Bauer, Laura L; Gourineni, Vishnupriya; Pelkman, Christine L; Fahey, George C; Swanson, Kelly S

    2015-09-01

    Prebiotics resist digestion, providing fermentable substrates for select gastrointestinal bacteria associated with health and well-being. Agave inulin differs from other inulin type fibers in chemical structure and botanical origin. Preclinical animal research suggests these differences affect bacterial utilization and physiologic outcomes. Thus, research is needed to determine whether these effects translate to healthy adults. We evaluated agave inulin utilization by the gastrointestinal microbiota by measuring fecal fermentative end products and bacterial taxa. A randomized, double-blind, placebo-controlled, 3-period, crossover trial was undertaken in healthy adults (n = 29). Participants consumed 0, 5.0, or 7.5 g agave inulin/d for 21 d with 7-d washouts between periods. Participants recorded daily dietary intake; fecal samples were collected during days 16-20 of each period and were subjected to fermentative end product analysis and 16S Illumina sequencing. Fecal Actinobacteria and Bifidobacterium were enriched (P inulin/d, respectively, compared with control. Desulfovibrio were depleted 40% with agave inulin compared with control. Agave inulin tended (P inulin (g/kcal) and Bifidobacterium (r = 0.41, P inulin/d) per kilocalorie was positively associated with fecal butyrate (r = 0.30, P = 0.005), tended to be positively associated with Bifidobacterium (r = 0.19, P = 0.08), and was negatively correlated with Desulfovibrio abundance (r = -0.31, P = 0.004). Agave inulin supplementation shifted the gastrointestinal microbiota composition and activity in healthy adults. Further investigation is warranted to determine whether the observed changes translate into health benefits in human populations. This trial was registered at clinicaltrials.gov as NCT01925560. © 2015 American Society for Nutrition.

  5. 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, pConduct Subscale, F=4.34, p=0.06). Fish oil treatment was associated with an improvement in one rating of hyperactivity (SDQ Hyperactivity Subscale, F=2.22, pchildren with disruptive behavior disorders.

  6. Efficacy and safety of creatine supplementation in juvenile dermatomyositis: A randomized, double-blind, placebo-controlled crossover trial.

    Science.gov (United States)

    Solis, Marina Yazigi; Hayashi, Ana Paula; Artioli, Guilherme Giannini; Roschel, Hamilton; Sapienza, Marcelo Tatit; Otaduy, Maria Concepción; De Sã Pinto, Ana Lucia; Silva, Clovis Artur; Sallum, Adriana Maluf Elias; Pereira, Rosa Maria R; Gualano, Bruno

    2016-01-01

    It has been suggested that creatine supplementation is safe and effective for treating idiopathic inflammatory myopathies, but no pediatric study has been conducted to date. The objective of this study was to examine the efficacy and safety of creatine supplementation in juvenile dermatomyositis (JDM) patients. In this study, JDM patients received placebo or creatine supplementation (0.1 g/kg/day) in a randomized, crossover, double-blind design. Subjects were assessed at baseline and after 12 weeks. The primary outcome was muscle function. Secondary outcomes included body composition, aerobic conditioning, health-related quality of life, and muscle phosphocreatine (PCr) content. Safety was assessed by laboratory parameters and kidney function measurements. Creatine supplementation did not affect muscle function, intramuscular PCr content, or any other secondary outcome. Kidney function was not affected, and no side effects were reported. Twelve weeks of creatine supplementation in JDM patients were well-tolerated and free of adverse effects, but treatment did not affect muscle function, intramuscular PCr, or any other parameter. © 2015 Wiley Periodicals, Inc.

  7. 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

    2017-12-01

    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 14 C-D-glucose transport across differentiated Caco-2/TC7 cell monolayers, but they inhibited uptake of 14 C-glucose into Xenopus oocytes expressing the human glucose transporter type 2. Further, some of the predicted pomegranate gut microbiota metabolites modulated 14 C-D-glucose and 14 C-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

  8. 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.

  9. Treatment of erectile dysfunction with sildenafil citrate in renal allograft recipients: a randomized, double-blind, placebo-controlled, crossover trial.

    Science.gov (United States)

    Sharma, Raj K; Prasad, Narayan; Gupta, Amit; Kapoor, Rakesh

    2006-07-01

    Erectile dysfunction (ED) is observed frequently in patients with end-stage renal disease, hemodialysis patients, and renal allograft recipients. There are few studies of sildenafil use in renal allograft recipients. The study is designed as a randomized, double-blind, placebo-controlled, crossover trial. Efficacy was assessed by using the self-administered International Index of Erectile Function (IIEF), a 15-question validated measure of ED, and a global efficacy question (Did the treatment improve your erection?). Thirty-two eligible renal transplant recipients were included in this study. After treatment with sildenafil citrate, patients had significantly better scores in 13 of 15 questions, except for questions 11 (desire frequency; P = 0.39) and 12 (desire level; P = 0.61). Treatment efficacy assessed through questions 3 (penetration ability; P satisfaction). Patients treated with sildenafil had significantly better scores in 4 domains compared with baseline, but a difference was not observed in the sexual desire domain (P = 0.32). There were no significant differences in scores between placebo and baseline in any domain. On the global efficacy question, 81.3% of patients showed improvement compared with 18.7% with placebo. There were no differences in areas under the curve and maximum cyclosporine concentrations before and after sildenafil therapy. No patient discontinued the drug because of side effects except for 1 patient with visual hallucination. Treatment with sildenafil in renal transplant recipients is a valid option with an effective response.

  10. 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.

  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. Chronic Effects of a Wild Green Oat Extract Supplementation on Cognitive Performance in Older Adults: A Randomised, Double-Blind, Placebo-Controlled, Crossover Trial

    Directory of Open Access Journals (Sweden)

    Narelle M. Berry

    2012-05-01

    Full Text Available Background and aim: Preliminary evaluation of a wild green oat extract (WGOE (Neuravena® ELFA®955, Frutarom, Switzerland revealed an acute cognitive benefit of supplementation. This study investigated whether regular daily WGOE supplementation would result in sustained cognitive improvements. Method: A 12-week randomised, double-blind, placebo-controlled cross-over trial of WGOE supplementation (1500 mg/day versus placebo was undertaken in 37 healthy adults aged 67 ± 0.8 years (mean ± SEM. Cognitive assessments included the Stroop colour-word test, letter cancellation, the rule-shift task, a computerised multi-tasking test battery and the trail-making task. All assessments were conducted in Week 12 and repeated in Week 24 whilst subjects were fasted and at least 18 h after taking the last dose of supplement. Result: Chronic WGOE supplementation did not affect any measures of cognition. Conclusion: It appears that the cognitive benefit of acute WGOE supplementation does not persist with chronic treatment in older adults with normal cognition. It remains to be seen whether sustained effects of WGOE supplementation may be more evident in those with mild cognitive impairment.

  13. The effect of almonds on inflammation and oxidative stress in Chinese patients with type 2 diabetes mellitus: a randomized crossover controlled feeding trial.

    Science.gov (United States)

    Liu, Jen-Fang; Liu, Yen-Hua; Chen, Chiao-Ming; Chang, Wen-Hsin; Chen, C-Y Oliver

    2013-04-01

    Almond consumption is associated with ameliorations in obesity, hyperlipidemia, hypertension, and hyperglycemia. The hypothesis of this 12-week randomized, crossover, controlled feeding trial was that almond consumption would ameliorate inflammation and oxidative stress in Chinese patients with type 2 diabetes mellitus (T2DM) (9 M, 11 F; 58 years; BMI: 26 kg/m²) with mild hyperlipidemia. After a 2-week run-in period, the patients were assigned to either a control NCEP step II diet (control diet) or almond diet for 4 weeks with a 2-week washout period between alternative diets. Almonds approximately at 56 g/day were added to the control diet to replace 20 % of total daily calorie intake. As compared to the control diet, the almond diet decreased IL-6 by a median 10.3 % (95 % confidence intervals 5.2, 12.6 %), CRP by a median 10.3 % (-24.1, 40.5), and TNF-α by a median 15.7 % (-0.3, 29.9). The almond diet also decreased plasma protein carbonyl by a median 28.2 % (4.7, 38.2) as compared to the C diet but did not alter plasma malondialdehyde. The A diet enhanced the resistance of LDL against Cu²⁺-induced oxidation by a median 16.3 % (7.4, 44.3) as compared to the C diet. Serum intercellular adhesion molecule-1 and vascular adhesion molecule-1 were not changed by both diets. Our results suggested that incorporation of almonds into a healthy diet could ameliorate inflammation and oxidative stress in patients with T2DM.

  14. A cluster randomized controlled cross-over bed net acceptability and preference trial in Solomon Islands: community participation in shaping policy for malaria elimination

    Directory of Open Access Journals (Sweden)

    Appleyard Bridget

    2009-12-01

    Full Text Available Abstract Background A key component of the malaria elimination strategy in Solomon Islands (SI is widespread coverage of long-lasting insecticidal nets (LLINs. The success of this strategy is dependent on LLIN acceptability and compliance. There has been unresolved debate among policy makers and donors as to which type of LLIN would be most appropriate for large-scale distribution in SI, and anecdotal reports of a lack of acceptability of certain brands of LLINs. A cluster randomized controlled crossover bed net acceptability and preference trial was therefore carried out from July to September, 2008 to inform policy and to facilitate community engagement and participation in the selection of the most appropriate LLIN for use in SI. Method A three-stage sampling method was used to randomly select the study population from Malaita Province, SI. Three brands of LLINs were assessed in this study: Olyset®, PermaNet® and DuraNet®. Bed net acceptability and preference were evaluated through surveys at three defined time points after short and longer-term trial of each LLIN. Results The acceptability of PermaNet® after short-term use (96.5% was significantly greater than Olyset® (67.3%, p and DuraNet® (69.8%, p . The acceptability of DuraNet® and Olyset® after short-term use was not significantly different at the 5% level. LLINs that were perceived not to prevent mosquito bites were significantly less acceptable than LLINs that were perceived to prevent mosquito bites (OR 0.15; 95%CI 0.03 to 0.6. LLINs that allow a pleasant night's sleep (OR 6.3; 95%CI:3.3-12.3 and have a soft texture (OR 5.7; 95%CI:1.9-20.5 were considered more acceptable than those that did not. Olyset®'s acceptability decreased over time and this was due to net wrinkling/shrinkage after washing resulting in reduced efficiency in preventing mosquito bites. The increase in DuraNet® acceptability was a result of a reduction in minor adverse events following longer-term use

  15. 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.

  16. Acute effects of combined exercise and oscillatory positive expiratory pressure therapy on sputum properties and lung diffusing capacity in cystic fibrosis: a randomized, controlled, crossover trial.

    Science.gov (United States)

    Radtke, Thomas; Böni, Lukas; Bohnacker, Peter; Maggi-Beba, Marion; Fischer, Peter; Kriemler, Susi; Benden, Christian; Dressel, Holger

    2018-06-14

    Regular airway clearance by chest physiotherapy and/or exercise is critical to lung health in cystic fibrosis (CF). Combination of cycling exercise and chest physiotherapy using the Flutter® device on sputum properties has not yet been investigated. This prospective, randomized crossover study compared a single bout of continuous cycling exercise at moderate intensity (experiment A, control condition) vs a combination of interval cycling exercise plus Flutter® (experiment B). Sputum properties (viscoelasticity, yield stress, solids content, spinnability, and ease of sputum expectoration), pulmonary diffusing capacity for nitric oxide (DLNO) and carbon monoxide (DLCO) were assessed at rest, directly and 45 min post-exercise (recovery) at 2 consecutive visits. Primary outcome was change in sputum viscoelasticity (G', storage modulus; G", loss modulus) over a broad frequency range (0.1-100 rad.s - 1 ). 15 adults with CF (FEV 1 range 24-94% predicted) completed all experiments. No consistent differences between experiments were observed for G' and G" and other sputum properties, except for ease of sputum expectoration during recovery favoring experiment A. DLNO, DLCO, alveolar volume (V A ) and pulmonary capillary blood volume (V cap ) increased during experiment A, while DLCO and V cap increased during experiment B (all P < 0.05). We found no differences in absolute changes in pulmonary diffusing capacity and its components between experiments, except a higher V A immediately post-exercise favoring experiment A (P = 0.032). The additional use of the Flutter® to moderate intensity interval cycling exercise has no measurable effect on the viscoelastic properties of sputum compared to moderate intensity continuous cycling alone. Elevations in diffusing capacity represent an acute exercise-induced effect not sustained post-exercise. ClinicalTrials.gov; No.: NCT02750722 ; URL: clinical.trials.gov; Registration date: April 25th, 2016.

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

    Science.gov (United States)

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

    2016-07-01

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

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

    Directory of Open Access Journals (Sweden)

    Mohammad Hossein Emami

    2014-01-01

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

  19. A Mobile Device App to Reduce Medication Errors and Time to Drug Delivery During Pediatric Cardiopulmonary Resuscitation: Study Protocol of a Multicenter Randomized Controlled Crossover Trial.

    Science.gov (United States)

    Siebert, Johan N; Ehrler, Frederic; Lovis, Christian; Combescure, Christophe; Haddad, Kevin; Gervaix, Alain; Manzano, Sergio

    2017-08-22

    During pediatric cardiopulmonary resuscitation (CPR), vasoactive drug preparation for continuous infusions is complex and time-consuming. The need for individual specific weight-based drug dose calculation and preparation places children at higher risk than adults for medication errors. Following an evidence-based and ergonomic driven approach, we developed a mobile device app called Pediatric Accurate Medication in Emergency Situations (PedAMINES), intended to guide caregivers step-by-step from preparation to delivery of drugs requiring continuous infusion. In a prior single center randomized controlled trial, medication errors were reduced from 70% to 0% by using PedAMINES when compared with conventional preparation methods. The purpose of this study is to determine whether the use of PedAMINES in both university and smaller hospitals reduces medication dosage errors (primary outcome), time to drug preparation (TDP), and time to drug delivery (TDD) (secondary outcomes) during pediatric CPR when compared with conventional preparation methods. This is a multicenter, prospective, randomized controlled crossover trial with 2 parallel groups comparing PedAMINES with a conventional and internationally used drug infusion rate table in the preparation of continuous drug infusion. The evaluation setting uses a simulation-based pediatric CPR cardiac arrest scenario with a high-fidelity manikin. The study involving 120 certified nurses (sample size) will take place in the resuscitation rooms of 3 tertiary pediatric emergency departments and 3 smaller hospitals. After epinephrine-induced return of spontaneous circulation, nurses will be asked to prepare a continuous infusion of dopamine using either PedAMINES (intervention group) or the infusion table (control group) and then prepare a continuous infusion of norepinephrine by crossing the procedure. The primary outcome is the medication dosage error rate. The secondary outcome is the time in seconds elapsed since the oral

  20. Dose-dependent social-cognitive effects of intranasal oxytocin delivered with novel Breath Powered device in adults with autism spectrum disorder: a randomized placebo-controlled double-blind crossover trial

    OpenAIRE

    Quintana, D S; Westlye, L T; Hope, S; N?rland, T; Elvs?shagen, T; D?rum, E; Rustan, ?; Valstad, M; Rezvaya, L; Lishaugen, H; Stens?nes, E; Yaqub, S; Smerud, K T; Mahmoud, R A; Djupesland, P G

    2017-01-01

    The neuropeptide oxytocin has shown promise as a treatment for symptoms of autism spectrum disorders (ASD). However, clinical research progress has been hampered by a poor understanding of oxytocin?s dose?response and sub-optimal intranasal delivery methods. We examined two doses of oxytocin delivered using a novel Breath Powered intranasal delivery device designed to improve direct nose-to-brain activity in a double-blind, crossover, randomized, placebo-controlled trial. In a randomized sequ...

  1. The Effects of Consumption of Bread Fortified With Soy Bean Flour on Metabolic Profile in Type 2 Diabetic Women: A Cross-over Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Moghaddam, Asma Salari; Entezari, Mohammad Hassan; Iraj, Bijan; Askari, Gholam Reza; Maracy, Mohammad Reza

    2014-12-01

    Diabetes mellitus is one of the most common chronic diseases in the world and has become a major threat for global health. Recent studies reported that the soy has beneficial effects in diabetic mellitus patients. The aim of this study was to assess the effects of soybean flour fortified bread consumption on metabolic profile in type 2 diabetic women. This randomized, cross-over, controlled clinical trial was carried out in 30 type 2 diabetic women. At first, a 2-week run-in period was applied. Then, participants were randomly assigned to either intervention or control groups. Participants in the intervention group were asked to replace 120 g of soybean flour fortified bread with the same amount of their usual bread intake or other cereal products for 6 weeks. After a 4 weeks washout period, participants were crossed over for another 6 weeks. Mean (±standard deviation) age and body mass index of subjects was 45.7 ± 3.8 years and 29.5 ± 3.9 kg/m(2), respectively. The results of our study showed no significant effects of soybean flour fortified bread on metabolic profile. We found a reduction in serum triglycerides (change difference: -3.7, P = 0.82), serum low-density lipoprotein-cholesterol (change difference: -11.2, P = 0.50), insulin (change difference: -3.6, P = 0.7), and homeostatic model assessment of insulin resistance (change differences: -0.57, P = 0.45) after 6 weeks but these changes were not statistically significant. No significant effects of soybean flour fortified bread on serum concentrations of fasting blood sugar, glycated hemoglobin, high-density lipoproteins and total cholesterol levels were found. Six weeks consumption of soybean flour fortified bread among diabetic patients had no significant effects on metabolic profile.

  2. The effects of consumption of bread fortified with soy bean flour on metabolic profile in type 2 diabetic women: A cross-over randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Asma Salari Moghaddam

    2014-01-01

    Full Text Available Background: Diabetes mellitus is one of the most common chronic diseases in the world and has become a major threat for global health. Recent studies reported that the soy has beneficial effects in diabetic mellitus patients. The aim of this study was to assess the effects of soybean flour fortified bread consumption on metabolic profile in type 2 diabetic women. Methods: This randomized, cross-over, controlled clinical trial was carried out in 30 type 2 diabetic women. At first, a 2-week run-in period was applied. Then, participants were randomly assigned to either intervention or control groups. Participants in the intervention group were asked to replace 120 g of soybean flour fortified bread with the same amount of their usual bread intake or other cereal products for 6 weeks. After a 4 weeks washout period, participants were crossed over for another 6 weeks. Results: Mean (±standard deviation age and body mass index of subjects was 45.7 ± 3.8 years and 29.5 ± 3.9 kg/m 2 , respectively. The results of our study showed no significant effects of soybean flour fortified bread on metabolic profile. We found a reduction in serum triglycerides (change difference: -3.7, P = 0.82, serum low-density lipoprotein-cholesterol (change difference: -11.2, P = 0.50, insulin (change difference: -3.6, P = 0.7, and homeostatic model assessment of insulin resistance (change differences: -0.57, P = 0.45 after 6 weeks but these changes were not statistically significant. No significant effects of soybean flour fortified bread on serum concentrations of fasting blood sugar, glycated hemoglobin, high-density lipoproteins and total cholesterol levels were found. Conclusions: Six weeks consumption of soybean flour fortified bread among diabetic patients had no significant effects on metabolic profile.

  3. A randomized double blind crossover placebo-controlled clinical trial to assess the effects of a mouthwash containing chlorine dioxide on oral malodor

    Directory of Open Access Journals (Sweden)

    Yokoyama Sayaka

    2008-12-01

    Full Text Available Abstract Background Previous research has shown the oxidizing properties and microbiological efficacies of chlorine dioxide (ClO2, however, its clinical efficacies on oral malodor have been evaluated only with organoleptic measurements (OM or sulphide monitors. No clinical studies have investigated the inhibitory effects of ClO2 on volatile sulfur compounds (VSCs using gas chromatography (GC. The aim of this study was to assess the inhibitory effects of a mouthwash containing ClO2 on morning oral malodor using OM and GC. Methods A randomized, double blind, crossover, placebo-controlled clinical trial was conducted among 15 healthy male volunteers, who were divided into 2 groups. In the first test phase, the group 1 subjects (N = 8 were instructed to rinse with the experimental mouthwash containing ClO2, and those in group 2 (N = 7 to rinse with the placebo mouthwash without ClO2. In the second test, phase after a one week washout period, each group used the opposite mouthwash. Oral malodor was evaluated before rinsing, right after rinsing and every 30 minutes up to 4 hours with OM, and concentrations of hydrogen sulfide (H2S, methyl mercaptan (CH3SH and dimethyl sulfide ((CH32S, the main VSCs of human oral malodor, were evaluated with GC. Results The baseline oral condition in the subjects in the 2 groups did not differ significantly. The mouthwash containing ClO2 improved morning bad breath according to OM and reduced concentrations of H2S, CH3SH and (CH32S according to GC up to 4 hours after rinsing. OM scores with ClO2 were significantly lower than those without ClO2 at all examination times. Significant reductions in the concentrations of the three kinds of VSCs measured by GC were also evident at all examination times. The concentrations of the three gases with ClO2 were significantly lower than those without ClO2 at most examination times. Conclusion In this explorative study, ClO2 mouthwash was effective at reducing morning malodor for 4

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

    Directory of Open Access Journals (Sweden)

    Tsedek Irit

    2008-08-01

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

  5. Effect of fibular repositioning taping in adult basketball players with chronic ankle instability: a randomized, placebo-controlled, crossover trial.

    Science.gov (United States)

    Alves, Yanina; Ribeiro, Fernando; Silva, Anabela G

    2017-07-05

    Chronic ankle instability presents a high incidence and prevalence in basketbal players. It's important to develop strategies to reduce the functional and mechanical limitations resulting from this condition. To compare the effect of Mulligan ́s fibular repositioning taping with a placebo taping immediatly after application and after a running test (Yo-Yo IRT). 16 adult basketball players (10 male, 6 female) with chronic ankle instability and mean age 21.50 ± 2.76 years old. Assessment of static postural control (15 seconds of unipedal stance test with eyes closed in a force platform), functional performance (figure 8 hop test and lateral hop test) and neuromuscular control (peroneus longus latency time in sudden inversion) in two conditions: Mulligan and Placebo. No significant effect was found for the intervantion factor in both hop tests (p>0.170), but there was a significant effect for the time factor (p<0.03). For the peroneus longus latency time, there was a significant interaction between factors (p=0.028) and also for time (p=0.042). No significant effect was found for any of the static postural control variables (area, speed and total displacement) (p≥0.10). There was no differences between Mulligan's fibular repositioning taping and Placebo taping in postural control and functional performance in basketball players with chronic ankle instability. However, Mulligan's taping appears to reduce peroneus longus latency time after a running when compared with a placebo taping.

  6. Atorvastatin reduces T-cell activation and exhaustion among HIV-infected cART-treated suboptimal immune responders in Uganda: a randomised crossover placebo-controlled trial.

    Science.gov (United States)

    Nakanjako, Damalie; Ssinabulya, Isaac; Nabatanzi, Rose; Bayigga, Lois; Kiragga, Agnes; Joloba, Moses; Kaleebu, Pontiano; Kambugu, Andrew D; Kamya, Moses R; Sekaly, Rafick; Elliott, Alison; Mayanja-Kizza, Harriet

    2015-03-01

    T-cell activation independently predicts mortality, poor immune recovery and non-AIDS illnesses during combination antiretroviral therapy (cART). Atorvastatin showed anti-immune activation effects among HIV-infected cART-naïve individuals. We investigated whether adjunct atorvastatin therapy reduces T-cell activation among cART-treated adults with suboptimal immune recovery. A randomised double-blind placebo-controlled crossover trial, of atorvastatin 80 mg daily vs. placebo for 12 weeks, was conducted among individuals with CD4 increase <295 cells/μl after seven years of suppressive cART. Change in T-cell activation (CD3 + CD4 + /CD8 + CD38 + HLADR+) and in T-cell exhaustion (CD3 + CD4 + /CD8 + PD1 + ) was measured using flow cytometry. Thirty patients were randomised, 15 to each arm. Atorvastatin resulted in a 28% greater reduction in CD4 T-cell activation (60% reduction) than placebo (32% reduction); P = 0.001. Atorvastatin also resulted in a 35% greater reduction in CD8-T-cell activation than placebo (49% vs. 14%, P = 0.0009), CD4 T-cell exhaustion (27% vs. 17% in placebo), P = 0.001 and CD8 T-cell exhaustion (27% vs. 16%), P = 0.004. There was no carry-over/period effect. Expected adverse events were comparable in both groups, and no serious adverse events were reported. Atorvastatin reduced T-cell immune activation and exhaustion among cART-treated adults in a Ugandan cohort. Atorvastatin adjunct therapy should be explored as a strategy to improve HIV treatment outcomes among people living with HIV in sub-Saharan Africa. © 2014 John Wiley & Sons Ltd.

  7. A randomized double-blind placebo-controlled crossover-style trial of buspirone in functional dysphagia and ineffective esophageal motility.

    Science.gov (United States)

    Aggarwal, Nitin; Thota, Prashanthi Nagavenkata; Lopez, Rocio; Gabbard, Scott

    2018-02-01

    Studies suggest that Ineffective Esophageal Motility (IEM) is the manometric correlate of Functional Dysphagia (FD). Currently, there is no accepted therapy for either condition. Buspirone is a serotonin modulating medication and has been shown to augment esophageal peristaltic amplitude in healthy volunteers. We aimed to determine if buspirone improves manometric parameters and symptoms in patients with overlapping IEM/FD. We performed a prospective, double-blind, placebo-controlled, crossover-style trial of 10 patients with IEM/FD. The study consisted of two 2-week treatment arms with a 2-week washout period. Outcomes measured at baseline, end of week 2, and week 6 include high resolution esophageal manometry (HREM), the Mayo Dysphagia Questionnaire-14 (MDQ-14), and the GERD-HRQL. The mean age of our 10 patients was 53 ± 9 years and 70% were female. After treatment with buspirone, 30% of patients had normalization of IEM on manometry; however, there was 30% normalization in the placebo group as well. Comparing buspirone to placebo, there was no statistically significant difference in the HREM parameters measured. There was also no statistically significant difference in symptom outcomes for buspirone compared to placebo. Of note, patients had a statistically significant decrease in the total GERD-HRQL total score when treated with placebo compared to baseline levels. Despite previous data demonstrating improved esophageal motility in healthy volunteers, our study shows no difference in terms of HREM parameters or symptom scores in IEM/FD patients treated with buspirone compared to placebo. Further research is necessary to identify novel agents for this condition. © 2017 John Wiley & Sons Ltd.

  8. Adjunctive treatment with lodenafil carbonate for erectile dysfunction in outpatients with schizophrenia and spectrum: a randomized, double-blind, crossover, placebo-controlled trial.

    Science.gov (United States)

    Nunes, Luciana Vargas Alves; Lacaz, Fernando Sargo; Bressan, Rodrigo Affonseca; Nunes, Sandra Odebrecht Vargas Alves; Mari, Jair de Jesus

    2013-04-01

    INTRODUCTION.: Evidence is accumulating to support the presence of erectile dysfunction in patients with schizophrenia. This dysregulation may be amenable to therapeutic intervention to improve adherence and quality of life of patients who suffer from schizophrenia and schizoaffective disorders. AIM.: We aimed to evaluate the use of adjunctive medication lodenafil for the treatment of erectile dysfunction in outpatients with schizophrenia and spectrum. METHODS.: The design was a randomized, double-blind, crossover, placebo-controlled trial with lodenafil and it was carried at the Schizophrenia Outpatients Program. MAIN OUTCOME MEASURES.: The measures used to assess sexual dysfunction were Arizona Sexual Experiences Scale (ASEX) and International Index of Erectile Function (IIEF). The Positive and Negative Syndrome Scale (PANSS) and the Quality of Life Scale (QLS) were also used. The measures included the levels of prolactin, estradiol, luteinizing hormone, sex hormone-binding globulin, free testosterone, and total testosterone at baseline and end point. Lodenafil and placebo pills were used by the patients for 16 weeks. RESULTS.: Fifty male outpatients fulfilled the criteria and 94% of the participants completed the study. Lodenafil and placebo produced improvement in ASEX, IIEF scale, PANSS, and QLS, and there was no statistical difference between lodenafil and placebo groups in all sexual domains in the results of PANSS and QLS and in the results of hormone levels. CONCLUSION.: These results indicate that both lodenafil and placebo were effective in the treatment of erectile dysfunction for schizophrenia. Placebo effect is very important in patients with schizophrenia and this study showed the importance of discussing sexuality and trying to treat these patients. Further studies designed to test treatments of erectile dysfunction in patients who suffer from schizophrenia are necessary. © 2013 International Society for Sexual Medicine.

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

    Science.gov (United States)

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

    2018-05-24

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

  10. 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

  11. A randomised control crossover trial of a theory based intervention to improve sun-safe and healthy behaviours in construction workers: study protocol.

    Science.gov (United States)

    Nioi, Amanda; Wendelboe-Nelson, Charlotte; Cowan, Sue; Cowie, Hilary; Rashid, Shahzad; Ritchie, Peter; Cherrie, Mark; Lansdown, Terry C; Cherrie, John W

    2018-02-15

    Exposure to sunlight can have both positive and negative health impacts. Excessive exposure to ultra-violet (UV) radiation from the sun can cause skin cancer, however insufficient exposure to sunlight has a detrimental effect on production of Vitamin D. In the construction industry there are onsite proactive behaviours for safety, but sun-safety remains a low priority. There is limited research on understanding the barriers to adopting sun-safe behaviours and the association this may have with Vitamin D production. This paper reports a protocol for an intervention study, using text messaging in combination with a supportive smartphone App. The intervention aims to both reduce UV exposure during months with higher UV levels and promote appropriate dietary changes to boost Vitamin D levels during months with low UV levels. Approximately 60 construction workers will be recruited across the United Kingdom. A randomised control crossover trial (RCCT) will be used to test the intervention, with randomisation at site level - i.e. participants will receive both the control (no text messages or supportive App support) and intervention (daily text messages and supportive App). Using the Theory of Planned Behaviour (TPB) the intervention focuses on supporting sun-safety and healthy dietary decisions in relation to Vitamin D intake. The intervention emphasises cultivating the perception of normative support in the workplace, increasing awareness of control and self-efficacy in taking sun-protective behaviours, making healthier eating choices to boost Vitamin D, and tackling stigmas attached to image and group norms. Each study epoch will last 21 days with intervention text messages delivered on workdays only. The supportive App will provide supplementary information about sun protective behaviours and healthy dietary choices. The primary outcome measure is 25-hydroxy-Vitamin D [25(OH)D] level (obtained using blood spot sampling), which will be taken pre and post control and

  12. Combined short- and long-axis ultrasound-guided central venous catheterization is superior to conventional techniques: A cross-over randomized controlled manikin trial.

    Directory of Open Access Journals (Sweden)

    Jun Takeshita

    Full Text Available Visualizing the needle tip using the short-axis (SA ultrasound-guided central venous catheterization approach can be challenging. It has been suggested to start the process with the SA approach and then switch to the long-axis (LA; however, to our knowledge, this combination has not been evaluated. We compared the combined short- and long-axis (SLA approach with the SA approach in a manikin study.We performed a prospective randomized controlled cross-over study in an urban emergency department and intensive care unit. Resident physicians in post-graduate years 1-2 performed a simulated ultrasound-guided internal jugular vein puncture using the SA and SLA approaches on manikins. Twenty resident physicians were randomly assigned to two equal groups: (1 one group performed punctures using the SA approach followed by SLA; and (2 the other performed the same procedures in the opposite order. We compared the success rate and procedure duration for the two approaches. Procedural success was defined as insertion of the guide-wire into the vein while visualizing the needle tip at the time of anterior wall puncture, without penetrating the posterior wall.Six resident physicians (30% performed both approaches successfully, while 12 (60% performed the SLA approach, but not the SA, successfully. Those who performed the SA approach successfully also succeeded with the SLA approach. Two resident physicians (10% failed to perform both approaches. The SLA approach had a significantly higher success rate than the SA approach (P < 0.001. The median (interquartile range procedure duration was 59.5 [46.0-88.5] seconds and 45.0 [37.5-84.0] seconds for the SLA and SA approaches, respectively. The difference of the duration between the two procedures was 15.5 [0-28.5] seconds. There was no significant difference in duration between the two approaches (P = 0.12.Using the SLA approach significantly improved the success rate of internal jugular vein puncture performed by

  13. 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

  14. Bloodcurdling movies and measures of coagulation: Fear Factor crossover trial

    NARCIS (Netherlands)

    Nemeth, Banne; Scheres, Luuk J. J.; Lijfering, Willem M.; Rosendaal, Frits R.

    2015-01-01

    To assess whether, as has been hypothesised since medieval times, acute fear can curdle blood. Crossover trial. Main meeting room of Leiden University's Department of Clinical Epidemiology, the Netherlands, converted to a makeshift cinema. 24 healthy volunteers aged ≤30 years recruited among

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

    Directory of Open Access Journals (Sweden)

    Sanne M van der Made

    Full Text Available In vitro and animal studies have shown positive effects of resveratrol on lipid and lipoprotein metabolism, but human studies specifically designed to examine these effects are lacking.The primary outcome parameter of this study in overweight and slightly obese subjects was the effect of resveratrol on apoA-I concentrations. Secondary outcome parameters were effects on other markers of lipid and lipoprotein metabolism, glucose metabolism, and markers for inflammation and endothelial function.This randomized, placebo-controlled crossover study was conducted in 45 overweight and slightly obese men (n = 25 and women (n = 20 with a mean age of 61 ± 7 years. Subjects received in random order resveratrol (150 mg per day or placebo capsules for 4 weeks, separated by a 4-week wash-out period. Fasting blood samples were collected at baseline and at the end of each intervention period.Compliance was excellent as indicated by capsule count and changes in resveratrol and dihydroresveratrol concentrations. No difference between resveratrol and placebo was found in any of the fasting serum or plasma metabolic risk markers (mean ± SD for differences between day 28 values of resveratrol vs. placebo: apoA-I; 0.00 ± 0.12 g/L (P = 0.791, apoB100; -0.01 ± 0.11 g/L (P = 0.545, HDL cholesterol; 0.00 ± 0.09 mmol/L (P = 0.721, LDL cholesterol -0.03 ± 0.57 mmol/L (P = 0.718, triacylglycerol; 0.10 ± 0.54 mmol/L (P = 0.687, glucose; -0.08 ± 0.28 mmol/L (P = 0.064, insulin; -0.3 ± 2.5 mU/L (P = 0.516. Also, no effects on plasma markers for inflammation and endothelial function were observed. No adverse events related to resveratrol intake were observed.150 mg of daily resveratrol intake for 4 weeks does not change metabolic risk markers related to cardiovascular health in overweight and slightly obese men and women. Effects on glucose metabolism warrant further study.ClinicalTrials.gov NCT01364961.

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

    Science.gov (United States)

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

    2017-04-14

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

  17. Effects of the pure flavonoids epicatechin and quercetin on vascular function and cardiometabolic health: a randomized, double-blind, placebo-controlled, crossover trial.

    Science.gov (United States)

    Dower, James I; Geleijnse, Johanna M; Gijsbers, Lieke; Zock, Peter L; Kromhout, Daan; Hollman, Peter C H

    2015-05-01

    Prospective cohort studies showed inverse associations between the intake of flavonoid-rich foods (cocoa and tea) and cardiovascular disease (CVD). Intervention studies showed protective effects on intermediate markers of CVD. This may be due to the protective effects of the flavonoids epicatechin (in cocoa and tea) and quercetin (in tea). We investigated the effects of supplementation of pure epicatechin and quercetin on vascular function and cardiometabolic health. Thirty-seven apparently healthy men and women aged 40-80 y with a systolic blood pressure (BP) between 125 and 160 mm Hg at screening were enrolled in a randomized, double-blind, placebo-controlled, crossover trial. CVD risk factors were measured before and after 4 wk of daily flavonoid supplementation. Participants received (-)-epicatechin (100 mg/d), quercetin-3-glucoside (160 mg/d), or placebo capsules for 4 wk in random order. The primary outcome was the change in flow-mediated dilation from pre- to postintervention. Secondary outcomes included other markers of CVD risk and vascular function. Epicatechin supplementation did not change flow-mediated dilation significantly (1.1% absolute; 95% CI: -0.1%, 2.3%; P = 0.07). Epicatechin supplementation improved fasting plasma insulin (Δ insulin: -1.46 mU/L; 95% CI: -2.74, -0.18 mU/L; P = 0.03) and insulin resistance (Δ homeostasis model assessment of insulin resistance: -0.38; 95% CI: -0.74, -0.01; P = 0.04) and had no effect on fasting plasma glucose. Epicatechin did not change BP (office BP and 24-h ambulatory BP), arterial stiffness, nitric oxide, endothelin 1, or blood lipid profile. Quercetin-3-glucoside supplementation had no effect on flow-mediated dilation, insulin resistance, or other CVD risk factors. Our results suggest that epicatechin may in part contribute to the cardioprotective effects of cocoa and tea by improving insulin resistance. It is unlikely that quercetin plays an important role in the cardioprotective effects of tea. This study

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

    Science.gov (United States)

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

    2014-04-01

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

  19. 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.

  20. 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.

    Science.gov (United States)

    Salari Moghaddam, Asma; Entezari, Mohammad Hassan; Iraj, Bijan; Askari, Gholamreza; Sharifi Zahabi, Elham; Maracy, Mohammad Reza

    2014-01-01

    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.

  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. 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 attention (r = -.540, p improve behavior, attention, and literacy in children with ADHD. © The Author(s) 2013.

  3. Eating marshmallows reduces ileostomy output: a randomized crossover trial.

    Science.gov (United States)

    Clarebrough, E; Guest, G; Stupart, D

    2015-12-01

    Anecdotally, many ostomates believe that eating marshmallows can reduce ileostomy effluent. There is a plausible mechanism for this, as the gelatine contained in marshmallows may thicken small bowel fluid, but there is currently no evidence that this is effective. This was a randomized crossover trial. Adult patients with well-established ileostomies were included. Ileostomy output was measured for 1 week during which three marshmallows were consumed three times daily, and for one control week where marshmallows were not eaten. There was a 2-day washout period. Patients were randomly allocated to whether the control or intervention week occurred first. In addition, a questionnaire was administered regarding patient's subjective experience of their ileostomy function. Thirty-one participants were recruited; 28 completed the study. There was a median reduction in ileostomy output volume of 75 ml per day during the study period (P = 0.0054, 95% confidence interval 23.4-678.3) compared with the control week. Twenty of 28 subjects (71%) experienced a reduction in their ileostomy output, two had no change and six reported an increase. During the study period, participants reported fewer ileostomy bag changes (median five per day vs six in the control period, P = 0.0255). Twenty of 28 (71%) reported that the ileostomy effluent was thicker during the study week (P = 0.023). Overall 19 (68%) participants stated they would use marshmallows in the future if they wanted to reduce or thicken their ileostomy output. Eating marshmallows leads to a small but statistically significant reduction in ileostomy output. Colorectal Disease © 2015 The Association of Coloproctology of Great Britain and Ireland.

  4. 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 (PPubMed Clinical Queries (PPubMed Clinical Queries users (PPubmed 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. Clinical trial of modulatory effects of oxytocin treatment on higher-order social cognition in autism spectrum disorder: a randomized, placebo-controlled, double-blind and crossover trial.

    Science.gov (United States)

    Preckel, Katrin; Kanske, Philipp; Singer, Tania; Paulus, Frieder M; Krach, Sören

    2016-09-21

    Autism spectrum disorders are neurodevelopmental conditions with severe impairments in social communication and interaction. Pioneering research suggests that oxytocin can improve motivation, cognition and attention to social cues in patients with autism spectrum disorder. The aim of this clinical trial is to characterize basic mechanisms of action of acute oxytocin treatment on neural levels and to relate these to changes in different levels of socio-affective and -cognitive functioning. This clinical study is a randomized, double-blind, cross-over, placebo-controlled, multicenter functional magnetic resonance imaging study with two arms. A sample of 102 male autism spectrum disorder patients, diagnosed with Infantile Autistic Disorder (F84.0 according to ICD-10), Asperger Syndrome (F84.5 according to ICD-10), or Atypical Autism (F84.1 according to ICD-10) will be recruited and will receive oxytocin and placebo nasal spray on two different days. Autism spectrum disorder patients will be randomized to determine who receives oxytocin on the first and who on the second visit. Healthy control participants will be recruited and case-control matched to the autism spectrum disorder patients. The primary outcome will be neural network activity, measured with functional magnetic resonance imaging while participants perform socio-affective and -cognitive tasks. Behavioral markers such as theory of mind accuracy ratings and response times will be assessed as secondary outcomes in addition to physiological measures such as skin conductance. Trait measures for alexithymia, interpersonal reactivity, and social anxiety will also be evaluated. Additionally, we will analyze the effect of oxytocin receptor gene variants and how these potentially influence the primary and secondary outcome measures. Functional magnetic resonance imaging assessments will take place at two time points which will be scheduled at least two weeks apart to ensure a sufficient wash-out time after oxytocin

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

    Directory of Open Access Journals (Sweden)

    Kielbassa Andrej M

    2011-04-01

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

  7. 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

    crossover designs. This trial was registered at clinicaltrials.gov as NCT01411631. © 2016 American Society for Nutrition.

  8. 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.

  9. ATM promotes the obligate XY crossover and both crossover control and chromosome axis integrity on autosomes.

    Directory of Open Access Journals (Sweden)

    Marco Barchi

    2008-05-01

    Full Text Available During meiosis in most sexually reproducing organisms, recombination forms crossovers between homologous maternal and paternal chromosomes and thereby promotes proper chromosome segregation at the first meiotic division. The number and distribution of crossovers are tightly controlled, but the factors that contribute to this control are poorly understood in most organisms, including mammals. Here we provide evidence that the ATM kinase or protein is essential for proper crossover formation in mouse spermatocytes. ATM deficiency causes multiple phenotypes in humans and mice, including gonadal atrophy. Mouse Atm-/- spermatocytes undergo apoptosis at mid-prophase of meiosis I, but Atm(-/- meiotic phenotypes are partially rescued by Spo11 heterozygosity, such that ATM-deficient spermatocytes progress to meiotic metaphase I. Strikingly, Spo11+/-Atm-/- spermatocytes are defective in forming the obligate crossover on the sex chromosomes, even though the XY pair is usually incorporated in a sex body and is transcriptionally inactivated as in normal spermatocytes. The XY crossover defect correlates with the appearance of lagging chromosomes at metaphase I, which may trigger the extensive metaphase apoptosis that is observed in these cells. In addition, control of the number and distribution of crossovers on autosomes appears to be defective in the absence of ATM because there is an increase in the total number of MLH1 foci, which mark the sites of eventual crossover formation, and because interference between MLH1 foci is perturbed. The axes of autosomes exhibit structural defects that correlate with the positions of ongoing recombination. Together, these findings indicate that ATM plays a role in both crossover control and chromosome axis integrity and further suggests that ATM is important for coordinating these features of meiotic chromosome dynamics.

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

    Science.gov (United States)

    2010-01-01

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

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

    Directory of Open Access Journals (Sweden)

    O'Connor Daniel W

    2010-07-01

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

  12. The effects of Nordic school meals on concentration and school performance in 8- to 11-year-old children in the OPUS School Meal Study: a cluster-randomised, controlled, cross-over trial

    DEFF Research Database (Denmark)

    Sørensen, Louise B.; Dyssegaard, Camilla B.; Damsgaard, Camilla T.

    2015-01-01

    . The OPUS (Optimal well-being, development and health for Danish children through a healthy New Nordic Diet) School Meal Study was a cluster-randomised, controlled, cross-over trial comparing a healthy school meal programme with the usual packed lunch from home (control) each for 3 months (NCT 01457794......It is widely assumed that nutrition can improve school performance in children; however, evidence remains limited and inconclusive. In the present study, we investigated whether serving healthy school meals influenced concentration and school performance of 8- to 11-year-old Danish children...... than reading speed. There was no effect on overall math performance or outcomes from the LRS. In conclusion, school meals did not affect CP, but improved reading performance, which is a complex cognitive activity that involves inference, and increased errors related to impulsivity and inattention...

  13. The Effect of Korean Red Ginseng on Sexual Function in Premenopausal Women: Placebo-Controlled, Double-Blind, Crossover Clinical Trial

    Directory of Open Access Journals (Sweden)

    Ho Seok Chung

    2015-01-01

    Full Text Available This study investigated whether Korean red ginseng (KRG extracts could improve sexual function in premenopausal women. Forty-one premenopausal women participated in this placebo-controlled, double-blind, and crossover clinical study with administration of either three ginseng capsules (1 g per capsule or placebo daily. After 8 weeks of medication of KRG or placebo, medication was changed for the subjects to placebo or KRG after 2 weeks of washout period. The efficacy of KRG extracts was measured by using Female Sexual Function Index (FSFI. Results. Twenty-three women completed the study. Total FSFI scores increased after KRG treatment (from 20.13±2.87 to 23.98±4.10, p=0.015 and placebo treatment (from 20.06±2.64 to 23.78±3.28, p=0.003. However, this change was not significantly different between the two groups (p=0.702. KRG treatment significantly improved sexual desire, arousal, orgasm, and satisfaction domains; however, there was no treatment effect compared with placebo. There was a case of gastric discomfort after taking KRG extracts. Oral administration of KRG extracts improved sexual function in premenopausal women; however, there were no statistical significant changes compared to placebo. It implies that KRG extracts have a substantial placebo effect in premenopausal women with sexual dysfunction.

  14. Antihyperalgesic efficacy of 5% lidocaine medicated plaster in capsaicin and sunburn pain models--two randomized, double-blinded, placebo-controlled crossover trials in healthy volunteers.

    Science.gov (United States)

    Gustorff, Burkhard; Hauer, David; Thaler, Johannes; Seis, Astrid; Draxler, Julia

    2011-12-01

    The aim of this research is to analyze analgesic efficacy of the 5% lidocaine medicated plaster in two randomized, double-blinded, placebo-controlled, crossover studies in 16 healthy volunteers using capsaicin and sunburn pain models. Lidocaine and placebo plasters were simultaneously applied to forearms and thighs at contralateral body sites for three alternating 12-h plaster-on/plaster-off periods. Between the second and third plaster-on period, 4.2-cm circular spots on both pretreated thighs were irradiated with three times the individual minimal erythema dose of UVB light. After the last plaster-on period, 20 μl of 0.1% capsaicin was injected intradermally into both forearms. The study was repeated using a single 12-h plaster application. The area of pinprick hyperalgesia was diminished by 53% (p sunburn model; the intensity of mechanical hyperalgesia to rigid filaments (8 - 512 mN) was reduced in both models. Cold pain perception threshold was reduced (19.7°C ± 8.0 vs 21.8°C ± 6.8 for placebo, p sunburn). Similar effects were observed in the 12-h exposure study. No effect was seen on capsaicin-induced spontaneous pain and flare size, or blood flow in the sunburn area, and heat hyperalgesia in either study. Lidocaine plaster effectively treats mechanical hyperalgesia and cold pain.

  15. Anti-Stress, Behavioural and Magnetoencephalography Effects of an l-Theanine-Based Nutrient Drink: A Randomised, Double-Blind, Placebo-Controlled, Crossover Trial

    Directory of Open Access Journals (Sweden)

    David J. White

    2016-01-01

    Full Text Available l-theanine (γ-glutamylethylamide is an amino acid found primarily in the green tea plant. This study explored the effects of an l-theanine-based nutrient drink on mood responses to a cognitive stressor. Additional measures included an assessment of cognitive performance and resting state alpha oscillatory activity using magnetoencephalography (MEG. Thirty-four healthy adults aged 18–40 participated in this double-blind, placebo-controlled, balanced crossover study. The primary outcome measure, subjective stress response to a multitasking cognitive stressor, was significantly reduced one hour after administration of the l-theanine drink when compared to placebo. The salivary cortisol response to the stressor was reduced three hours post-dose following active treatment. No treatment-related cognitive performance changes were observed. Resting state alpha oscillatory activity was significantly greater in posterior MEG sensors after active treatment compared to placebo two hours post-dose; however, this effect was only apparent for those higher in trait anxiety. This change in resting state alpha oscillatory activity was not correlated with the change in subjective stress response or the cortisol response, suggesting further research is required to assess the functional relevance of these treatment-related changes in resting alpha activity. These findings further support the anti-stress effects of l-theanine.

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

    Science.gov (United States)

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

    2012-01-01

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

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

    Science.gov (United States)

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

    2015-06-01

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

  18. Effects of Pomegranate Juice on Cardiovascular Risk Factors in Patients with Metabolic Syndrome: a Double-Blinded, Randomized Crossover Controlled Trial.

    Science.gov (United States)

    Moazzen, Hossein; Alizadeh, Mohammad

    2017-06-01

    The aim of this study is to investigate the simultaneous effect of pomegranate juice on components of the metabolic syndrome, including high sensitive C-reactive protein (hs-CRP) as an inflammatory index and glycemic and lipid profile indices in patients with metabolic syndrome. In a double- blind 2*2 crossover study, 30 individuals suffering from metabolic syndrome received a daily dose of 500 mL pomegranate juice for a period of one week. After one week of wash out period, they received a placebo for one week. Lipid profile, blood glucose control indices including fasting blood glucose, fasting insulin, homeostatic model assessment of insulin resistance (HOMA-IR), systolic and diastolic blood pressure, and hs-CRP were measured at the beginning and end of the study. To analyze the data, a repeated measure analysis of variance and a t-test were performed. The results indicated that in comparison to the placebo, pomegranate juice was more effective in reducing the systolic and diastolic blood pressure (p = 0.00) and hs-CRP (p = 0.018). The level of triglyceride (p = 0.030) and very low-density lipoproteins cholesterol (VLDL-C) (p = 0.014) were increased after the consumption of pomegranate juice, as opposed to the baseline condition. The rest of lipid profile, fasting blood glucose (FBS), insulin, and HOMA-IR of the participants did not show any significant difference. Natural pomegranate juice supplementation lowered the level of systolic and diastolic blood pressure in patients with metabolic syndrome as well as their blood hs-CRP. However, it also increased their triglyceride and VLDL-C.

  19. Comparing the Effects of Oral Contraceptives Containing Levonorgestrel With Products Containing Antiandrogenic Progestins on Clinical, Hormonal, and Metabolic Parameters and Quality of Life in Women With Polycystic Ovary Syndrome: Crossover Randomized Controlled Trial Protocol

    Science.gov (United States)

    Amiri, Mina; Nahidi, Fatemeh; Khalili, Davood; Bidhendi-Yarandi, Razieh

    2017-01-01

    Background Oral contraceptives (OCs) have been used as a first-line option for medical treatment in women with polycystic ovary syndrome (PCOS). Despite theoretical superiority of products containing antiandrogenic progestins compared to OCs containing levonorgestrel (LNG), the clinical advantage of these compounds remains unclear. Objective The aim of this study was to compare the effects of OCs containing LNG with products containing antiandrogenic progestins including cyproterone acetate, drospirenone, and desogestrel on clinical, hormonal, and metabolic parameters and quality of life in women with PCOS. Methods We conducted a 6-arm crossover randomized controlled trial with each arm including OCs containing LNG and one of those 3 OCs containing antiandrogenic progestins. The anthropometric and clinical manifestations and hormonal and biochemical parameters of participants were assessed at 6 time points including baseline, after washout period, and 3 and 6 months after intervention. Results The study is ongoing and follow-up of recruited women will continue until 2018. Conclusions This study will provide scientific evidence on comparability of OCs with the various progesterones that will assist in decision making taking into account cost effectiveness. Trial Registration Iranian Registry of Clinical Trials IRCT201702071281N2; http://www.irct.ir/searchresult.php? keyword=&id=1281&number=2&prt=12869&total=10&m=1 (Archived by WebCite at http://www.webcitation.org/6tSP8FNWo) PMID:28963092

  20. The effects of Nordic school meals on concentration and school performance in 8- to 11-year-old children in the OPUS School Meal Study: a cluster-randomised, controlled, cross-over trial.

    Science.gov (United States)

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

    2015-04-28

    It is widely assumed that nutrition can improve school performance in children; however, evidence remains limited and inconclusive. In the present study, we investigated whether serving healthy school meals influenced concentration and school performance of 8- to 11-year-old Danish children. The OPUS (Optimal well-being, development and health for Danish children through a healthy New Nordic Diet) School Meal Study was a cluster-randomised, controlled, cross-over trial comparing a healthy school meal programme with the usual packed lunch from home (control) each for 3 months (NCT 01457794). The d2 test of attention, the Learning Rating Scale (LRS) and standard tests on reading and mathematics proficiency were administered at baseline and at the end of each study period. Intervention effects were evaluated using hierarchical mixed models. The school meal intervention did not influence concentration performance (CP; primary outcome, n 693) or processing speed; however, the decrease in error percentage was 0·18 points smaller (Pschool year. The percentage of correct sentences also improved (Pperformance or outcomes from the LRS. In conclusion, school meals did not affect CP, but improved reading performance, which is a complex cognitive activity that involves inference, and increased errors related to impulsivity and inattention. These findings are worth examining in future trials.

  1. A randomized, placebo-controlled, crossover, double-blind trial of the NK1 receptor antagonist aprepitant on gastrointestinal motor function in healthy humans

    DEFF Research Database (Denmark)

    Fuglsang, S.; Madsen, Jan Lysgård

    2008-01-01

    emptying, small intestinal transit and colonic transit of a radiolabelled, 1600-kJ mixed liquid and solid meal ingested on day 2. RESULTS: Aprepitant did not change gastric retention at 15 min, gastric half emptying time, gastric mean transit time, time to small intestinal transit of 10%, small intestinal...... in healthy humans. METHODS: Twelve healthy volunteers participated in a crossover, double-blind study. In random order, each volunteer had a 125-mg capsule of aprepitant or placebo on day 1 followed by an 80-mg capsule of aprepitant or placebo on days 2-5. Gamma camera imaging was used to measure gastric...

  2. Comparison of chocolate to cacao-free white chocolate in Parkinson's disease: a single-dose, investigator-blinded, placebo-controlled, crossover trial.

    Science.gov (United States)

    Wolz, Martin; Schleiffer, Christine; Klingelhöfer, Lisa; Schneider, Christine; Proft, Florian; Schwanebeck, Uta; Reichmann, Heinz; Riederer, Peter; Storch, Alexander

    2012-11-01

    A previous questionnaire study suggests an increased chocolate consumption in Parkinson's disease (PD). The cacao ingredient contains caffeine analogues and biogenic amines, such as β-phenylethylamine, with assumed antiparkinsonian effects. We thus tested the effects of 200 g of chocolate containing 80 % of cacao on UPDRS motor score after 1 and 3 h in 26 subjects with moderate non-fluctuating PD in a mono-center, single-dose, investigator-blinded crossover study using cacao-free white chocolate as placebo comparator. At 1 h after chocolate intake, mean UPDRS motor scores were mildly decreased compared to baseline in both treatments with significant results only for dark chocolate [-1.3 (95 % CI 0.18-2.52, RMANOVA F = 4.783, p = 0.013¸ Bonferroni p = 0.021 for 1 h values)]. A 2 × 2-cross-over analysis revealed no significant differences between both treatments [-0.54 ± 0.47 (95 % CI -1.50 to 0.42), p = 0.258]. Similar results were obtained at 3 h after intake. β-phenylethylamine blood levels were unaltered. Together, chocolate did not show significant improvement over white cacao-free chocolate in PD motor function.

  3. Bloodcurdling movies and measures of coagulation: Fear Factor crossover trial.

    Science.gov (United States)

    Nemeth, Banne; Scheres, Luuk J J; Lijfering, Willem M; Rosendaal, Frits R

    2015-12-16

    To assess whether, as has been hypothesised since medieval times, acute fear can curdle blood. Crossover trial. Main meeting room of Leiden University's Department of Clinical Epidemiology, the Netherlands, converted to a makeshift cinema. 24 healthy volunteers aged ≤30 years recruited among students, alumni, and employees of the Leiden University Medical Center: 14 were assigned to watch a frightening (horror) movie followed by a non-threatening (educational) movie and 10 to watch the movies in reverse order. The movies were viewed more than a week apart at the same time of day and both lasted approximately 90 minutes. The primary outcome measures were markers, or "fear factors" of coagulation activity: blood coagulant factor VIII, D-dimer, thrombin-antithrombin complexes, and prothrombin fragments 1+2. The secondary outcome was participant reported fear experienced during each movie using a visual analogue fear scale. All participants completed the study. The horror movie was perceived to be more frightening than the educational movie on a visual analogue fear scale (mean difference 5.4, 95% confidence interval 4.7 to 6.1). The difference in factor VIII levels before and after watching the movies was higher for the horror movie than for the educational movie (mean difference of differences 11.1 IU/dL (111 IU/L), 95% confidence interval 1.2 to 21.0 IU/dL). The effect of either movie on levels of thrombin-antithrombin complexes, D-dimer, and prothrombin fragments 1+2 did not differ. Frightening (in this case, horror) movies are associated with an increase of blood coagulant factor VIII without actual thrombin formation in young and healthy adults. Trial registration ClinicalTrials.gov NCT02601053. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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

    Science.gov (United States)

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

    2017-06-07

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

  5. 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.

  6. Reading from an iPad or from a book in bed: the impact on human sleep. A randomized controlled crossover trial.

    Science.gov (United States)

    Grønli, Janne; Byrkjedal, Ida Kristiansen; Bjorvatn, Bjørn; Nødtvedt, Øystein; Hamre, Børge; Pallesen, Ståle

    2016-05-01

    To objectively and subjectively compare whether reading a story for 30 min from an iPad or from a book in bed prior to sleep will differentially affect sleep. Sixteen students (12 females, mean age 25.1 ± 2.9 years) underwent ambulatory (sleeping in their own beds at home) polysomnographic (PSG) recordings in a counterbalanced crossover design consisting of three PSG nights (one adaptation night, two test nights) and two different reading materials: read from an iPad or from a book. Illumination was measured during reading and Karolinska Sleepiness Scale was completed prior to turning the light off. Sleep diaries were kept to assess subjective sleep parameters from day to day. Illumination was higher in the iPad condition compared to the book condition (58.3 ± 6.9 vs 26.7 ± 8.0 lux, p book. No parameters of sleep state timing and sleep onset latency differed between the two reading conditions. Although there was no direct effect on time spent in different sleep states and self-reported sleep onset latency, the use of an iPad which emits blue enriched light impinges acutely on sleepiness and EEG characteristics of sleep pressure. Hence, the use of commercially available tablets may have consequences in terms of alertness, circadian physiology, and sleep. Published by Elsevier B.V.

  7. Effects of Low Versus Moderate Glycemic Index Diets on Aerobic Capacity in Endurance Runners: Three-Week Randomized Controlled Crossover Trial

    Directory of Open Access Journals (Sweden)

    Krzysztof Durkalec-Michalski

    2018-03-01

    Full Text Available The glycemic index (GI of ingested carbohydrates may influence substrate oxidation during exercise and athletic performance. Therefore, the aim of this study was to assess the effect of low- and moderate-GI three-week diets on aerobic capacity and endurance performance in runners. We conducted a randomized crossover feeding study of matched diets differing only in GI (low vs. moderate in 21 endurance-trained runners. Each participant consumed both, low- (LGI and moderate-GI (MGI high-carbohydrate (~60% and nutrient-balanced diets for three weeks each. At the beginning and end of each diet, participants had their aerobic capacity and body composition measured and performed a 12-min running test. After LGI, time to exhaustion during incremental cycling test (ICT and distance covered in the 12-min run were significantly increased. The MGI diet led to an increase in maximal oxygen uptake ( V ˙ O2max, but no performance benefits were found after the MGI diet. The LGI and MGI diets improved time and workload at gas exchange threshold (GET during ICT. The results indicate that a three-week high-carbohydrate LGI diet resulted in a small but significant improvement in athletic performance in endurance runners. Observed increase in V ˙ O2max on MGI diet did not affect performance.

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

    Directory of Open Access Journals (Sweden)

    Anna Pedret

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

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Science.gov (United States)

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

    2017-01-01

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

  11. Use of the learning conversation improves instructor confidence in life support training: An open randomised controlled cross-over trial comparing teaching feedback mechanisms.

    Science.gov (United States)

    Baldwin, Lydia J L; Jones, Christopher M; Hulme, Jonathan; Owen, Andrew

    2015-11-01

    Feedback is vital for the effective delivery of skills-based education. We sought to compare the sandwich technique and learning conversation structured methods of feedback delivery in competency-based basic life support (BLS) training. Open randomised crossover study undertaken between October 2014 and March 2015 at the University of Birmingham, United Kingdom. Six-hundred and forty healthcare students undertaking a European Resuscitation Council (ERC) BLS course were enrolled, each of whom was randomised to receive teaching using either the sandwich technique or the learning conversation. Fifty-eight instructors were randomised to initially teach using either the learning conversation or sandwich technique, prior to crossing-over and teaching with the alternative technique after a pre-defined time period. Outcome measures included skill acquisition as measured by an end-of-course competency assessment, instructors' perception of teaching with each feedback technique and candidates' perception of the feedback they were provided with. Scores assigned to use of the learning conversation by instructors were significantly more favourable than for the sandwich technique across all but two assessed domains relating to instructor perception of the feedback technique, including all skills-based domains. No difference was seen in either assessment pass rates (80.9% sandwich technique vs. 77.2% learning conversation; OR 1.2, 95% CI 0.85-1.84; p=0.29) or any domain relating to candidates' perception of their teaching technique. This is the first direct comparison of two feedback techniques in clinical medical education using both quantitative and qualitative methodology. The learning conversation is preferred by instructors providing competency-based life support training and is perceived to favour skills acquisition. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  12. EffenDys-Fentanyl Buccal Tablet for the Relief of Episodic Breathlessness in Patients With Advanced Cancer: A Multicenter, Open-Label, Randomized, Morphine-Controlled, Crossover, Phase II Trial.

    Science.gov (United States)

    Simon, Steffen T; Kloke, Marianne; Alt-Epping, Bernd; Gärtner, Jan; Hellmich, Martin; Hein, Rebecca; Piel, Maren; Cornely, Oliver A; Nauck, Friedemann; Voltz, Raymond

    2016-11-01

    Episodic breathlessness is a frequent and burdensome symptom in cancer patients but pharmacological treatment is limited. To determine time to onset, efficacy, feasibility, and safety of transmucosal fentanyl in comparison to immediate-release morphine for the relief of episodic breathlessness. Phase II, investigator-initiated, multicenter, open-label, randomized, morphine-controlled, crossover trial with open-label titration of fentanyl buccal tablet (FBT) in inpatients with incurable cancer. The primary outcome was time to onset of meaningful breathlessness relief. Secondary outcomes were efficacy (breathlessness intensity difference at 10 and 30 minutes; sum of breathlessness intensity difference at 15 and 60 minutes), feasibility, and safety. Study was approved by local ethics committees. Twenty-five of 1341 patients were eligible, 10 patients agreed to participate (four female, mean age 58 ± 11, mean Karnofsky score 67 ± 11). Two patients died before final visits and two patients dropped-out because of disease progression leaving six patients for analysis with 61 episodes of breathlessness. Mean time to onset was for FBT 12.7 ± 10.0 and for immediate-release morphine 23.6 ± 15.1 minutes with a mean difference of -10.9 minutes (95% CI = -24.5 to 2.7, P = 0.094). Efficacy measures were predominately in favor for FBT. Both interventions were safe. Feasibility failed because of too much study demands for a very ill patient group. The description of a faster and greater relief of episodic breathlessness by transmucosal fentanyl versus morphine justifies further evaluation by a full-powered trial. Copyright © 2016. Published by Elsevier Inc.

  13. A crossover randomised and controlled trial of the impact of active video games on motor coordination and perceptions of physical ability in children at risk of Developmental Coordination Disorder.

    Science.gov (United States)

    Straker, L; Howie, E; Smith, A; Jensen, L; Piek, J; Campbell, A

    2015-08-01

    Impaired motor development can significantly affect a child's life and may result in an increased risk of a range of physical and psychological disorders. Active video game (AVG) interventions have been demonstrated to enhance motor skills in children with Developmental Coordination Disorder (DCD); however a home-based intervention has not been assessed. The primary aim of this study was to compare the changes in motor coordination between a 16 week period of AVG use, with 16 weeks of normal activities (NAG). The secondary aim was to compare the child and parent perceptions of their physical performance between the AVG and NAG conditions. Twenty-one 9-12 year olds (10 males) were confirmed to be at risk of DCD (⩽ 16th percentile Movement Assessment Battery for Children-2nd edition (MABC-2) and ⩽ 15th percentile Developmental Coordination Disorder Questionnaire (DCDQ)) and participated in this crossover randomised and controlled trial. Data was collected at study entry, after the first 16 week condition and following the final 16 week condition, including; (1) the MABC-2, (2) three-dimensional motion analysis of single leg balance and finger-nose tasks, and (3) parent perception of physical skills. Participant perception of physical skills was collected only after the first and second conditions. There was no significant difference between AVG and NAG for any of the primary variables including the MABC-2, balance centre-of-mass path distance and finger-nose path distance. There was no significant intervention effect for secondary measures of motor coordination; however the children perceived their motor skills to be significantly enhanced as a result of the AVG intervention in comparison to the period of no intervention. A 16 week home based AVG intervention did not enhance motor skills in children with DCD, although they perceived their physical skills to be significantly improved. Australia and New Zealand Clinical trials Registry (ACTRN 12611000400965

  14. Dose-dependent social-cognitive effects of intranasal oxytocin delivered with novel Breath Powered device in adults with autism spectrum disorder: a randomized placebo-controlled double-blind crossover trial.

    Science.gov (United States)

    Quintana, D S; Westlye, L T; Hope, S; Nærland, T; Elvsåshagen, T; Dørum, E; Rustan, Ø; Valstad, M; Rezvaya, L; Lishaugen, H; Stensønes, E; Yaqub, S; Smerud, K T; Mahmoud, R A; Djupesland, P G; Andreassen, O A

    2017-05-23

    The neuropeptide oxytocin has shown promise as a treatment for symptoms of autism spectrum disorders (ASD). However, clinical research progress has been hampered by a poor understanding of oxytocin's dose-response and sub-optimal intranasal delivery methods. We examined two doses of oxytocin delivered using a novel Breath Powered intranasal delivery device designed to improve direct nose-to-brain activity in a double-blind, crossover, randomized, placebo-controlled trial. In a randomized sequence of single-dose sessions, 17 male adults with ASD received 8 international units (IU) oxytocin, 24IU oxytocin or placebo followed by four social-cognitive tasks. We observed an omnibus main effect of treatment on the primary outcome measure of overt emotion salience as measured by emotional ratings of faces (η 2 =0.18). Compared to placebo, 8IU treatment increased overt emotion salience (P=0.02, d=0.63). There was no statistically significant increase after 24IU treatment (P=0.12, d=0.4). The effects after 8IU oxytocin were observed despite no significant increase in peripheral blood plasma oxytocin concentrations. We found no significant effects for reading the mind in the eyes task performance or secondary outcome social-cognitive tasks (emotional dot probe and face-morphing). To our knowledge, this is the first trial to assess the dose-dependent effects of a single oxytocin administration in autism, with results indicating that a low dose of oxytocin can significantly modulate overt emotion salience despite minimal systemic exposure.

  15. A Prospective Randomized, Double-Blind, Two-Period Crossover Pharmacokinetic Trial Comparing Green Coffee Bean Extract-A Botanically Sourced Caffeine-With a Synthetic USP Control.

    Science.gov (United States)

    Morton, Kayce; Knight, Katelin; Kalman, Douglas; Hewlings, Susan

    2018-04-16

    Coffee is a primary dietary source of the chlorogenic acids (CGAs) of phenolic compounds. Coffee contains caffeine and other phytonutrients, including CGAs. Caffeine on its own has been well characterized and descried pharmacokinetically in the literature, less so for CGAs. The purpose of this double-blind crossover study was to determine the comparative pharmacokinetics of CGAs with caffeine (natural extract) with synthetic caffeine (US Pharmacopeia [USP] standard). Sixteen healthy male subjects were randomly assigned to take 1 dose of product 1, 60 mg of botanically sourced caffeine from 480 mg of green coffee bean extract, or product 2, 60 mg of synthetic USP caffeine, with 5 days between. Blood analysis was done to determine the levels of CGA compounds, more specifically 3-, 4-, and 5-caffeoylquinic acid (CQA), and serum caffeine. The natural caffeine extract exhibited mean peak concentrations (C max ) of 3-CQA (11.4 ng/mL), 4-CQA (6.84 ng/mL), and 5-CQA (7.20 ng/mL). The mean systemic 4-hour exposure (AUC 0-4 h ) was 3-CQA (27.3 ng·h/mL), 4-CQA (16.1 ng·h/mL), and 5-CQA (15.7 ng·h/mL). The median t max was 3-CQA (1.00 hour), 4-CQA (1.00 hour), and 5-CQA (1.50 hours). The t max of caffeine was 0.75 hours (natural extract) and 0.63 hours (synthetic caffeine). C max and AUC 0-4 h of serum caffeine were statistically equivalent between products. The geometric least-squares mean ratios (GMRs) of C max and AUC 0-4 h of caffeine were 97.77% (natural extract) and 98.33% (synthetic caffeine). It would appear that CGA compounds from the natural caffeine extract are bioavailable, and 3-CGA may be the compound most absorbed. In addition, caffeine sourced from natural extract versus synthetic were statistically similar for pharmacokinetic parameters. There were no adverse events or safety concerns. © 2018 The Authors. Clinical Pharmacology in Drug Development Published by Wiley Periodicals, Inc. on behalf of The American College of Clinical Pharmacology.

  16. A Link between Meiotic Prophase Progression and CrossoverControl

    Energy Technology Data Exchange (ETDEWEB)

    Carlton, Peter M.; Farruggio, Alfonso P.; Dernburg, Abby F.

    2005-07-06

    During meiosis, most organisms ensure that homologous chromosomes undergo at least one exchange of DNA, or crossover, to link chromosomes together and accomplish proper segregation. How each chromosome receives a minimum of one crossover is unknown. During early meiosis in Caenorhabditis elegans and many other species, chromosomes adopt a polarized organization within the nucleus, which normally disappears upon completion of homolog synapsis. Mutations that impair synapsis even between a single pair of chromosomes in C. elegans delay this nuclear reorganization. We quantified this delay by developing a classification scheme for discrete stages of meiosis. Immunofluorescence localization of RAD-51 protein revealed that delayed meiotic cells also contained persistent recombination intermediates. Through genetic analysis, we found that this cytological delay in meiotic progression requires double-strand breaks and the function of the crossover-promoting heteroduplex HIM-14 (Msh4) and MSH-5. Failure of X chromosome synapsis also resulted in impaired crossover control on autosomes, which may result from greater numbers and persistence of recombination intermediates in the delayed nuclei. We conclude that maturation of recombination events on chromosomes promotes meiotic progression, and is coupled to the regulation of crossover number and placement. Our results have broad implications for the interpretation of meiotic mutants, as we have shown that asynapsis of a single chromosome pair can exert global effects on meiotic progression and recombination frequency.

  17. The effect of small solar powered 'Bͻkͻͻ' net fans on mosquito net use: results from a randomized controlled cross-over trial in southern Ghana.

    Science.gov (United States)

    Briët, Olivier J T; Yukich, Joshua O; Pfeiffer, Constanze; Miller, William; Jaeger, Mulako S; Khanna, Nitin; Oppong, Samuel; Nardini, Peter; Ahorlu, Collins K; Keating, Joseph

    2017-01-03

    Long-lasting insecticidal nets (LLINs) are ineffective malaria transmission prevention tools if they are unused. Discomfort due to heat is the most commonly reported reason for not using nets, but this problem is largely unaddressed. With increasing rural electrification and the dropping price of solar power, fans could improve comfort inside nets and be affordable to populations in malaria endemic areas. Here, results are presented from a pilot randomized controlled cross-over study testing the effect of fans on LLIN use. Eighty-three households from two rural communities in Greater Accra, Ghana, randomized into three groups, participated in a 10-month cross-over trial. After a screening survey to identify eligible households, all households received new LLINs. Bͻkͻͻ net fan systems (one fan per member) were given to households in Group 1 and water filters were given to households in Group 2. At mid-point, Group 1 and 2 crossed over interventions. Households in Group 1 and 2 participated in fortnightly surveys on households' practices related to nets, fans and water filters, while households in Group 3 were surveyed only at screening, mid-point and study end. Entomological and weather data were collected throughout the study. Analysis took both 'per protocol' (PP) and 'intention to treat' (ITT) approaches. The mid- and end-point survey data from Group 1 and 2 were analysed using Firth logistic regressions. Fortnightly survey data from all groups were analysed using logistic regressions with random effects. Provision of fans to households appeared to increase net use in this study. Although the increase in net use explained by fans was not significant in the primary analyses (ITT odds ratio 3.24, p > 0.01; PP odds ratio = 1.17, p > 0.01), it was significant in secondary PP analysis (odds ratio = 1.95, p Fan use was 90-100% depending on the fortnightly visit. This pilot study could not provide definitive evidence that fans increase net use. A larger

  18. Catalytic Activity Control via Crossover between Two Different Microstructures

    KAUST Repository

    Zhou, Yuheng; Zhu, Yihan; Wang, Zhi-Qiang; Zou, Shihui; Ma, Guicen; Xia, Ming; Kong, Xueqian; Xiao, Liping; Gong, Xue-Qing; Fan, Jie

    2017-01-01

    microstructural control through the crossover between multiply-twinned nanoparticle (MTP) and single crystal (SC) can be readily achieved by solvent post-treatment on gold nanoparticles (AuNPs). Polar solvents (e.g. water, methanol) direct the transformation from

  19. Acute glucoregulatory and vascular outcomes of three strategies for interrupting prolonged sitting time in postmenopausal women: A pilot, laboratory-based, randomized, controlled, 4-condition, 4-period crossover trial.

    Directory of Open Access Journals (Sweden)

    Jacqueline Kerr

    Full Text Available Prolonged sitting is associated with cardiometabolic and vascular disease. Despite emerging evidence regarding the acute health benefits of interrupting prolonged sitting time, the effectiveness of different modalities in older adults (who sit the most is unclear.In preparation for a future randomized controlled trial, we enrolled 10 sedentary, overweight or obese, postmenopausal women (mean age 66 years ±9; mean body mass index 30.6 kg/m2 ±4.2 in a 4-condition, 4-period crossover feasibility pilot study in San Diego to test 3 different sitting interruption modalities designed to improve glucoregulatory and vascular outcomes compared to a prolonged sitting control condition. The interruption modalities included: a 2 minutes standing every 20 minutes; b 2 minutes walking every hour; and c 10 minutes standing every hour. During each 5-hr condition, participants consumed two identical, standardized meals. Blood samples, blood pressure, and heart rate were collected every 30 minutes. Endothelial function of the superficial femoral artery was measured at baseline and end of each 5-hr condition using flow-mediated dilation (FMD. Participants completed each condition on separate days, in randomized order. This feasibility pilot study was not powered to detect statistically significant differences in the various outcomes, however, analytic methods (mixed models were used to test statistical significance within the small sample size.Nine participants completed all 4 study visits, one participant completed 3 study visits and then was lost to follow up. Net incremental area under the curve (iAUC values for postprandial plasma glucose and insulin during the 5-hr sitting interruption conditions were not significantly different compared to the control condition. Exploratory analyses revealed that the 2-minute standing every 20 minutes and the 2-minute walking every hour conditions were associated with a significantly lower glycemic response to the second

  20. Prospective cluster controlled crossover trial to compare the impact of an improved hydrogen peroxide disinfectant and a quaternary ammonium-based disinfectant on surface contamination and health care outcomes.

    Science.gov (United States)

    Boyce, John M; Guercia, Kerri A; Sullivan, Linda; Havill, Nancy L; Fekieta, Renee; Kozakiewicz, Janet; Goffman, David

    2017-09-01

    Quaternary ammonium-based (Quat) disinfectants are widely used, but they have disadvantages. This was a 12-month prospective cluster controlled crossover trial. On 4 wards, housekeepers performed daily cleaning using a disinfectant containing either 0.5% improved hydrogen peroxide (IHP) or Quat. Each month, 5-8 high-touch surfaces in several patient rooms on each ward were tagged with a fluorescent marker and cultured before and after cleaning. Hand hygiene compliance rates and antimicrobial usage on study wards were obtained from hospital records. Outcomes included aerobic colony counts (ACCs), percent of wiped surfaces yielding no growth after cleaning, and a composite outcome of incidence densities of nosocomial acquisition and infection caused by vancomycin-resistant enterococci, methicillin-resistant Staphylococcus aureus, and Clostridium difficile infection. Statistical analysis was performed using χ 2 test, Fisher exact test, Welch test, and logistic regression methods. Mean ACCs per surface after cleaning were significantly lower with IHP (14.0) than with Quat (22.2) (P = .003). The proportion of surfaces yielding no growth after cleaning was significantly greater with IHP (240/500; 48%) than with Quat (182/517; 35.2%) (P < .0001). Composite incidence density of nosocomial colonization or infection with IHP (8.0) was lower than with Quat (10.3) (incidence rate ratio, 0.77; P = .068; 95% confidence interval, 0.579-1.029). Compared with a Quat disinfectant, the IHP disinfectant significantly reduced surface contamination and reduced a composite colonization or infection outcome. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2018-04-20

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

  2. Hormonal and metabolic effects of polyunsaturated fatty acids in young women with polycystic ovary syndrome: results from a cross-sectional analysis and a randomized, placebo-controlled, crossover trial.

    LENUS (Irish Health Repository)

    Phelan, Niamh

    2012-02-01

    BACKGROUND: Polycystic ovary syndrome (PCOS) is characterized by an adverse metabolic profile. Although dietary changes are advocated, optimal nutritional management remains uncertain. Polyunsaturated fatty acids (PUFAs), particularly long-chain (LC) n-3 (omega-3) PUFAs, improve metabolic health, but their therapeutic potential in PCOS is unknown. OBJECTIVES: We aimed to determine the associations between plasma PUFAs and metabolic and hormonal aspects of PCOS to investigate the efficacy of LC n-3 PUFA supplementation and to support the findings with mechanistic cellular studies. DESIGN: We selected a cross-sectional PCOS cohort (n = 104) and conducted a principal component analysis on plasma fatty acid profiles. Effects of LC n-3 PUFA supplementation on fasting and postprandial metabolic and hormonal markers were determined in PCOS subjects (n = 22) by a randomized, crossover, placebo-controlled intervention. Direct effects of n-6 (omega-6) compared with n-3 PUFAs on steroidogenesis were investigated in primary bovine theca cells. RESULTS: Cross-sectional data showed that a greater plasma n-6 PUFA concentration and n-6:n-3 PUFA ratio were associated with higher circulating androgens and that plasma LC n-3 PUFA status was associated with a less atherogenic lipid profile. LC n-3 PUFA supplementation reduced plasma bioavailable testosterone concentrations (P < 0.05), with the greatest reductions in subjects who exhibited greater reductions in plasma n-6:n-3 PUFA ratios. The treatment of bovine theca cells with n-6 rather than with n-3 PUFAs up-regulated androstenedione secretion (P < 0.05). CONCLUSIONS: Cross-sectional data suggest that PUFAs modulated hormonal and lipid profiles and that supplementation with LC n-3 PUFAs improves androgenic profiles in PCOS. In bovine theca cells, arachidonic acid modulated androstenedione secretion, which suggests an indirect effect of n-3 PUFAs through the displacement of or increased competition with n-6 PUFAs. This trial was

  3. Sample size calculations for cluster randomised crossover trials in Australian and New Zealand intensive care research.

    Science.gov (United States)

    Arnup, Sarah J; McKenzie, Joanne E; Pilcher, David; Bellomo, Rinaldo; Forbes, Andrew B

    2018-06-01

    The cluster randomised crossover (CRXO) design provides an opportunity to conduct randomised controlled trials to evaluate low risk interventions in the intensive care setting. Our aim is to provide a tutorial on how to perform a sample size calculation for a CRXO trial, focusing on the meaning of the elements required for the calculations, with application to intensive care trials. We use all-cause in-hospital mortality from the Australian and New Zealand Intensive Care Society Adult Patient Database clinical registry to illustrate the sample size calculations. We show sample size calculations for a two-intervention, two 12-month period, cross-sectional CRXO trial. We provide the formulae, and examples of their use, to determine the number of intensive care units required to detect a risk ratio (RR) with a designated level of power between two interventions for trials in which the elements required for sample size calculations remain constant across all ICUs (unstratified design); and in which there are distinct groups (strata) of ICUs that differ importantly in the elements required for sample size calculations (stratified design). The CRXO design markedly reduces the sample size requirement compared with the parallel-group, cluster randomised design for the example cases. The stratified design further reduces the sample size requirement compared with the unstratified design. The CRXO design enables the evaluation of routinely used interventions that can bring about small, but important, improvements in patient care in the intensive care setting.

  4. Pre-meal inulin consumption does not affect acute energy intake in overweight and obese middle-aged and older adults: A randomized controlled crossover pilot trial.

    Science.gov (United States)

    Smiljanec, Katarina; Mitchell, Cassie M; Privitera, Olivia F; Neilson, Andrew P; Davy, Kevin P; Davy, Brenda M

    2017-06-01

    Three-fourths of adults older than 55 years in the United States are overweight or obese. Prebiotics including inulin-type fructans may benefit with weight management. We aimed to investigate the acute effects of pre-meal inulin consumption on energy intake (EI) and appetite in older adults. Sedentary, overweight or obese middle-aged and older adults ( n = 7, 60.9 ± 4.4 years, BMI 32.9 ± 4.3 kg/m 2 ) ingested inulin (10 g) or a water preload before each test period in a randomly assigned order. EI, appetite and gastrointestinal symptoms were monitored during the following 24 h. No differences in EI were noted between conditions (inulin: 14744 ± 5552 kJ, control: 13924 ± 4904 kJ, p > 0.05). Rumbling was increased with inulin consumption ( p inulin consumption does not acutely decrease EI or suppress appetite in older adults. Further research should address individual differences among diets, eating behaviors, and microbiota profiles.

  5. 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 (SpO 2 ), 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.

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

    NARCIS (Netherlands)

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

    2013-01-01

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

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

    DEFF Research Database (Denmark)

    Nielsen, Jimmi; Thode, Dorrit; Stenager, Elsebeth

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

  8. Moderate alcohol consumption increases insulin sensitivity and ADIPOQ expression in postmenopausal women: A randomised, crossover trial

    NARCIS (Netherlands)

    Joosten, M.M.; Beulens, J.W.J.; Kersten, S.; Hendriks, H.F.J.

    2008-01-01

    Aims/hypothesis: To determine whether 6 weeks of daily, moderate alcohol consumption increases expression of the gene encoding adiponectin (ADIPOQ) and plasma levels of the protein, and improves insulin sensitivity in postmenopausal women. Methods: In a randomised, open-label, crossover trial

  9. A randomized, double-blind, crossover, placebo-controlled clinical trial to assess effects of the single ingestion of a tablet containing lactoferrin, lactoperoxidase, and glucose oxidase on oral malodor.

    Science.gov (United States)

    Nakano, Manabu; Shimizu, Eiju; Wakabayashi, Hiroyuki; Yamauchi, Koji; Abe, Fumiaki

    2016-03-22

    The main components of oral malodor have been identified as volatile sulfur compounds (VSCs) including hydrogen sulfide (H2S) and methyl mercaptan (CH3SH). VSCs also play an important role in the progression of periodontal disease. The aim of the present study was to assess the effects of the single ingestion of a tablet containing 20 mg of lactoferrin, 2.6 mg of lactoperoxidase, and 2.6 mg of glucose oxidase on VSCs in the mouth. Subjects with VSCs greater than the olfactory threshold in their mouth air ingested a test or placebo tablet in two crossover phases. The concentrations of VSCs were monitored at baseline and 10 and 30 min after ingestion of the tablets using portable gas chromatography. Thirty-nine subjects were included in the efficacy analysis based on a full analysis set (FAS). The concentrations of total VSCs and H2S at 10 min were significantly lower in the test group than in the placebo group (-0.246 log ng/10 ml [95 % CI -0.395 to -0.098], P = 0.002; -0.349 log ng/10 ml; 95 % CI -0.506 to -0.192; P oxidase has suppressive effects on oral malodor. This trial was registered with the University Hospital Medical Information Network Clinical Trial Registry (number: UMIN000015140 , date of registration: 16/09/2014).

  10. Performance and safety of the second-generation female condom (FC2) versus the Woman's, the VA worn-of-women, and the Cupid female condoms: a randomised controlled non-inferiority crossover trial.

    Science.gov (United States)

    Beksinska, Mags E; Piaggio, Gilda; Smit, Jennifer A; Wu, Junqing; Zhang, Yufeng; Pienaar, Jacqueline; Greener, Ross; Zhou, Ying; Joanis, Carol

    2013-09-01

    New designs of female condom have been developed to reduce costs and improve acceptability. To secure regulatory approvals, clinical studies are needed to verify performance. We aimed to assess the functional performance and safety of three new condom types-the Woman's Condom, the VA worn-of-women (wow) Condom Feminine, and the Cupid female condom-against the existing second-generation female condom (FC2). We did a randomised controlled, non-inferiority, four-period crossover trial at three sites in Shanghai, China, and one site in Durban, South Africa, between May 1, 2011, and Jan 31, 2012. Participants aged 18-45 years who were sexually active, monogamous, not pregnant, and not sex workers, were eligible for inclusion if they were literate, had no known allergies to the study products; used a reliable, non-barrier method of contraception, and had no visible or reported sexually transmitted infections. We used a computer-generated randomisation sequence with a Williams square design of size four to assign patients (1:1:1:1) to the FC2 control device, or the Woman's, VA wow, or Cupid condoms, with 12 potential allocations. Randomisation was stratified by site. Participants were not masked to condom type, but allocation was concealed from study investigators. The primary non-inferiority endpoints were total clinical failure and total female condom failure, with a non-inferiority margin of 3%. Women were asked to use five of each condom type and were interviewed after use of each type. We also assessed safety data for each type. We did both per-protocol and intention-to-treat analyses. We calculated frequencies and percentages for each failure event and estimated differences in performance with a generalised estimating equation model. This study is registered, number DOH-27-0113-4271. 616 women were assessed for eligibility, of whom 600 were randomly assigned to condom-type order (30, 120, and 150 women in the three sites in China, and 300 women in the site in South

  11. Patient satisfaction with laser-sintered removable partial dentures: A crossover pilot clinical trial.

    Science.gov (United States)

    Almufleh, Balqees; Emami, Elham; Alageel, Omar; de Melo, Fabiana; Seng, Francois; Caron, Eric; Nader, Samer Abi; Al-Hashedi, Ashwaq; Albuquerque, Rubens; Feine, Jocelyne; Tamimi, Faleh

    2018-04-01

    Clinical data regarding newly introduced laser-sintered removable partial dentures (RPDs) are needed before this technique can be recommended. Currently, only a few clinical reports have been published, with no clinical studies. This clinical trial compared short-term satisfaction in patients wearing RPDs fabricated with conventional or computer-aided design and computer-aided manufacturing (CAD-CAM) laser-sintering technology. Twelve participants with partial edentulism were enrolled in this pilot crossover double-blinded clinical trial. Participants were randomly assigned to wear cast or CAD-CAM laser-sintered RPDs for alternate periods of 30 days. The outcome of interest was patient satisfaction as measured using the McGill Denture Satisfaction Instrument. Assessments was conducted at 1, 2, and 4 weeks. The participant's preference in regard to the type of prosthesis was assessed at the final evaluation. The linear mixed effects regression models for repeated measures were used to analyze the data, using the intention-to-treat principle. To assess the robustness of potential, incomplete adherence, sensitivity analyses were conducted. Statistically significant differences were found in patients' satisfaction between the 2 methods of RPD fabrication. Participants were significantly more satisfied with laser-sintered prostheses than cast prostheses in regard to general satisfaction, ability to speak, ability to clean, comfort, ability to masticate, masticatory efficiency, and oral condition (Premovable partial dentures may lead to better outcomes in terms of patient satisfaction in the short term. The conclusion from this pilot study requires confirmation by a larger randomized controlled trial. ClinicalTrials.gov. A study about patient satisfaction with laser-sintered removable partial dentures; NCT02769715. Copyright © 2017 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  12. A randomized, controlled, crossover trial of oral midazolam and hydroxyzine for pediatric dental sedation Sedação com midazolam e hidroxizina por via oral em Odontopediatria: ensaio clínico randomizado, controlado e cruzado

    Directory of Open Access Journals (Sweden)

    Alessandra Rodrigues de Almeida Lima

    2003-09-01

    Full Text Available The effectiveness of oral midazolam in pediatric dentistry is controversial. This randomized, controlled, crossover, double blind clinical trial was conducted in order to study the effect of midazolam, used either alone or in association with hydroxyzine, during child dental treatment. Thirty seven dental sedation sessions were carried out on 11 ASA I uncooperative children less than five years-old. In each appointment children were randomly assigned to groups: P - placebo, M - midazolam (1.0 mg/kg, or MH - midazolam (0.75 mg/kg plus hydroxyzine (2.0 mg/kg. Vital signs (blood pressure, breathing rate, pulse and oxygen saturation and behavior parameters (consciousness, crying, movement, overall behavior were evaluated every 15 minutes. Friedman and Wilcoxon statistical tests were used to compare groups and different moments in the same group. Normal values of vital signs were usually registered. Heart rate increased in groups P and M as the session went on. Group M presented less crying and movement at the first 15 minutes of treatment. Group MH caused more drowsiness at the beginning of the session. Overall behavior was better in group M than in groups P or MH. Group M produced effective sedation in 77% of the cases, and group MH did so in 30.8%. It was concluded that midazolam was effective and safe, and its association with hydroxyzine did not lead to additional advantages in pediatric dental sedation.Há controvérsias quanto aos benefícios do midazolam na sedação de crianças durante a atenção odontológica. Conduziu-se um ensaio clínico controlado, cruzado e duplo-cego para comparar o efeito sedativo em Odontopediatria da administração oral do midazolam, associado ou não à hidroxizina. Trinta e sete sessões foram realizadas em 11 crianças menores de cinco anos, ASA I. Em cada atendimento, os pacientes receberam aleatoriamente o medicamento conforme os grupos: P - placebo, M - midazolam (1,0 mg/kg; MH - midazolam (0,75 mg

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

    Science.gov (United States)

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

    2015-10-01

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

  14. 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.

  15. The joy of six: how to control your crossovers.

    Science.gov (United States)

    Globus, Samuel T; Keeney, Scott

    2012-03-30

    Meiotic cells tightly regulate the number and distribution of crossovers to promote accurate chromosome segregation. Yokoo and colleagues uncover a metazoan-specific, cyclin-like protein that is crucial for crossover formation. They utilize this protein's unique properties to explore a remarkable example of biological numerology, whereby nearly every meiotic cell in C. elegans makes precisely six crossovers, one for each of its six chromosome pairs. Copyright © 2012 Elsevier Inc. All rights reserved.

  16. 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.

  17. The acute impact of the intake of four types of bread on satiety and blood concentrations of glucose, insulin, free fatty acids, triglyceride and acylated ghrelin. A randomized controlled cross-over trial.

    Science.gov (United States)

    Bo, S; Seletto, M; Choc, A; Ponzo, V; Lezo, A; Demagistris, A; Evangelista, A; Ciccone, G; Bertolino, M; Cassader, M; Gambino, R

    2017-02-01

    The purpose of the present study is to compare the effects of four different breads (one commercial par-baked wheat bread, three sourdough breads prepared with commercial wheat flour, organic wheat flour, organic einkorn flour) in 16 healthy subjects. The primary outcome of this randomized cross-over trial was evaluating intra-individual changes in glycemic areas-under-the-curve (AUCs) after 50g carbohydrate portions of each bread; secondary outcomes were changes in insulin, fatty free acids (FFA), triglyceride, acylated ghrelin and satiety AUCs. Blood samples and satiety ratings were collected every 30-min for 2-h after the consumption of each bread. The einkorn flour showed the lowest amylase activity, the commercial flour the highest; commercial bread had the highest carbohydrate content and the lowest dietary fiber content. Glucose AUCs were significantly lower after the consumption of sourdough breads made with organic (12,754±1433mg/dL×h) and einkorn flour (12,216±1210mg/dL×h), with respect to the commercial bread (13,849±2193mg/dL×h). Insulin AUCs decreased after the consumption of all sourdough breads when compared to commercial bread. FFA and triglyceride AUCs did not differ by kind of breads. Median ghrelin AUC was significantly lower and satiety higher after the einkorn bread (3710pg/mL×h; 3225±2414, respectively) than after commercial bread consumption (4140pg/mL×h; 1706±1766, respectively), but not with other sourdough breads. In conclusion, the use of sourdough may improve the nutritional features of breads; einkorn bread induced the least disturbance in carbohydrate homeostasis and the greater satiety. If confirmed by further research, these results might have implications in the approach towards chronic dysmetabolic diseases. Copyright © 2016 Elsevier Ltd. All rights reserved.

  18. Effect of lung deflation with indacaterol plus glycopyrronium on ventricular filling in patients with hyperinflation and COPD (CLAIM): a double-blind, randomised, crossover, placebo-controlled, single-centre trial.

    Science.gov (United States)

    Hohlfeld, Jens M; Vogel-Claussen, Jens; Biller, Heike; Berliner, Dominik; Berschneider, Korbinian; Tillmann, Hanns-Christian; Hiltl, Simone; Bauersachs, Johann; Welte, Tobias

    2018-02-21

    Pulmonary hyperinflation in chronic obstructive pulmonary disease (COPD) is associated with reduced biventricular end-diastolic volumes and increased morbidity and mortality. The combination of a long-acting β agonist (LABA) and a muscarinic antagonist (LAMA) is more effective in reducing hyperinflation than LABA-inhaled corticosteroid combination therapy but whether dual bronchodilation improves cardiac function is unknown. We did a double-blind, randomised, two-period crossover, placebo-controlled, single-centre study (CLAIM) at the Fraunhofer Institute of Toxicology and Experimental Medicine (Hannover, Germany), a specialty clinic. Eligible participants were patients aged at least 40 years with COPD, pulmonary hyperinflation (defined by a baseline residual volume >135% of predicted), a smoking history of at least ten pack-years, and airflow limitation (FEV 1 <80% predicted and post-bronchodilator FEV 1 : forced vital capacity <0·7). Patients with stable cardiovascular disease were eligible, but those with arrhythmias, heart failure, unstable ischaemic heart disease, or uncontrolled hypertension were not. We randomly assigned participants (1:1) to either receive a combined inhaled dual bronchodilator containing the LABA indacaterol (110 μg as maleate salt) plus the LAMA glycopyrronium (50 μg as bromide salt) once per day for 14 days, followed by a 14-day washout, then a matched placebo for 14 days, or to receive the same treatments in reverse order. The randomisation was done using lists and was concealed from patients and investigators. The primary endpoint was the effect of indacaterol-glycopyrronium versus placebo on left-ventricular end-diastolic volume measured by MRI done on day 1 (visit 4) and day 15 (visit 5) in treatment period 1 and on day 29 (visit 6) and day 43 (visit 7) in treatment period 2 in the per-protocol population. Left-ventricular end-diastolic volume was indexed to body surface area. Safety was assessed in all participants who received

  19. 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.

  20. A six-month crossover chemoprevention clinical trial of tea in smokers and non-smokers: methodological issues in a feasibility study

    Science.gov (United States)

    2012-01-01

    Background Chemoprevention crossover trials of tea can be more efficient than parallel designs but the attrition and compliance rates with such trials are unknown. Methods Attrition (dropouts) and compliance with treatment were assessed in a 25-week randomized, placebo controlled, crossover, feasibility clinical trial of four tea treatments to investigate the effect of tea on oral cancer biomarkers. Each treatment lasted 4 weeks with 2 weeks of washout in between. Participants were 32 smokers and 33 non-smokers without any evidence of premalignant oral lesions. The interventions consisted of packets of green tea, black tea, caffeinated water, or placebo. Participants were assigned to each treatment for four weeks, and were instructed to drink five packets per day while on the treatment. Dropout from the trial and compliance (consumption of ≥ 85% of the prescribed treatment packets) are the main outcome measures reported. Results There was a high rate of dropout (51%) from the study, and the rates were significantly higher among smokers (64%) than non-smokers (36%). Among participants who completed the study the rate of compliance was 72%. The highest rates of dropouts occurred between the first and second treatment visits in both smokers (38% dropout) and non-smokers (18% dropout). Throughout the study smokers were more likely to dropout than non-smokers. Black tea treatment was associated with the highest rates of dropout among smokers (37%), but was associated with the lowest rate of dropout among non-smokers (4%). Conclusions In a study conducted to test the feasibility of a four-treatment crossover tea trial, a high rate of dropout among smokers and non-smokers was observed. Multi-arm crossover tea trials might pose a higher burden on participants and research is needed to improve adherence and treatment compliance in such trials. Trial registration number ISRCTN70410203 PMID:22800470

  1. Catalytic Activity Control via Crossover between Two Different Microstructures

    KAUST Repository

    Zhou, Yuheng

    2017-09-08

    Metal nanocatalysts hold great promise for a wide range of heterogeneous catalytic reactions, while the optimization strategy of catalytic activity is largely restricted by particle size or shape control. Here, we demonstrate that a reversible microstructural control through the crossover between multiply-twinned nanoparticle (MTP) and single crystal (SC) can be readily achieved by solvent post-treatment on gold nanoparticles (AuNPs). Polar solvents (e.g. water, methanol) direct the transformation from MTP to SC accompanied by the disappearance of twinning and stacking faults. A reverse transformation from SC to MTP is achieved in non-polar solvent (e.g. toluene) mixed with thiol ligands. The transformation between two different microstructures is directly observed by in-situ TEM and leads to a drastic modulation of catalytic activity towards the gas-phase selective oxidation of alcohols. There is a quasi-linear relationship between TOFs and MTP concentrations. Based on the combined experimental and theoretical investigations of alcohol chemisorption on these nanocatalysts, we propose that the exposure of {211}-like microfacets associated with twin boundaries and stack faults accounts for the strong chemisorption of alcohol molecules on MTP AuNPs and thus the exceptionally high catalytic activity.

  2. A randomized, double-masked, placebo-controlled crossover trial on the effects of L-ornithine on salivary cortisol and feelings of fatigue of flushers the morning after alcohol consumption

    Directory of Open Access Journals (Sweden)

    Kokubo Takeshi

    2013-02-01

    Full Text Available Abstract Background Residual alcohol effects on physiological and psychological symptoms are commonly experienced the morning after alcohol consumption. The purpose of this study was to assess the effects of L-ornithine on subjective feelings and salivary stress markers the morning after alcohol consumption and to investigate whether L-ornithine acutely accelerates ethanol metabolism. Methods This study had a randomized, placebo-controlled, double-masked crossover design. Subjects were all healthy Japanese adults with the ‘flusher’ phenotype for alcohol tolerance. In experiment 1, 11 subjects drank 0.4 g/kg body weight alcohol 1.5 h before their usual bedtime. Half an hour after drinking, they ingested either a placebo or 400 mg ornithine. The next morning on awakening, subjects completed a questionnaire containing a visual analog scale (VAS, the Oguri-Shirakawa-Azumi sleep inventory MA version (OSA-MA, and a profile of mood states (POMS and collected a saliva sample for measurement of salivary stress markers (cortisol, secretory immunoglobulin A, and α-amylase. In experiment 2, placebo or 400 mg ornithine were administrated to 16 subjects both before and after drinking, and the feeling of drunkenness, breath ethanol concentration and one-leg standing time were repeatedly investigated until 180 min after alcohol consumption. Results There were significant decreases in “awareness”, “feeling of fatigue” and “lassitude” VAS scores and in “anger-hostility” and “confusion” POMS scores and a significant increase in “sleep length” in the OSA-MA test. Salivary cortisol concentrations on awakening were reduced after ornithine supplementation. There were no differences between ornithine and placebo in any of the subjective or physiological parameters of acute alcohol metabolism. Conclusions Taking 400 mg ornithine after alcohol consumption improved various negative feelings and decreased the salivary stress marker cortisol the

  3. A randomized, double-blind, crossover, placebo-controlled trial of 6 weeks benfotiamine treatment on postprandial vascular function and variables of autonomic nerve function in Type 2 diabetes.

    Science.gov (United States)

    Stirban, A; Pop, A; Tschoepe, D

    2013-10-01

    In a pilot study we suggested that benfotiamine, a thiamine prodrug, prevents postprandial endothelial dysfunction in people with Type 2 diabetes mellitus. The aim of this study was to test these effects in a larger population. In a double-blind, placebo-controlled, randomized, crossover study, 31 people with Type 2 diabetes received 900 mg/day benfotiamine or a placebo for 6 weeks (with a washout period of 6 weeks between). At the end of each treatment period, macrovascular and microvascular function were assessed, together with variables of autonomic nervous function in a fasting state, as well as 2, 4 and 6 h following a heated, mixed test meal. Participants had an impaired baseline flow-mediated dilatation (2.63 ± 2.49%). Compared with the fasting state, neither variable changed postprandially following the placebo treatment. The 6 weeks' treatment with high doses of benfotiamine did not alter this pattern, either in the fasting state or postprandially. Among a subgroup of patients with the highest flow-mediated dilatation, following placebo treatment there was a significant postprandial flow-mediated dilatation decrease, while this effect was attenuated by benfotiamine pretreatment. In people with Type 2 diabetes and markedly impaired fasting flow-mediated dilatation, a mixed test meal does not further deteriorate flow-mediated dilatation or variables of microvascular or autonomic nervous function. Because no significant deterioration of postprandial flow-mediated dilatation, microvascular or autonomic nervous function tests occurred after placebo treatment, a prevention of the postprandial deterioration of these variables with benfotiamine was not feasible. © 2013 The Authors. Diabetic Medicine © 2013 Diabetes UK.

  4. Endoscopic comparison of gastroduodenal injury with over-the-counter doses of new fast-dissolving ibuprofen and paracetamol formulations: a randomized, placebo-controlled, 4-way crossover clinical trial

    Directory of Open Access Journals (Sweden)

    Lanza FL

    2018-04-01

    Full Text Available Frank L Lanza,1 Agron Collaku,2 Dongzhou J Liu3 1Department of Gastroenterology, Houston Institute for Clinical Research, Houston, TX, USA; 2Biostatistics Department, GlaxoSmithKline Consumer Healthcare, Parsippany, NJ, USA; 3Global Clinical Development, GlaxoSmithKline, Collegeville, PA, USA Background: While gastrointestinal (GI effects of standard ibuprofen and N-acetyl-p-­aminophenol (APAP have been reported, upper GI injury following treatment with fast-dissolving (FD formulations of these analgesics has not been investigated. We evaluated upper GI effects of over-the-counter doses of 2 FD ibuprofen products and 1 FD-APAP product. Methods: In a randomized, placebo-controlled, endoscopist-blinded, 4-way crossover study, 28 healthy subjects received FD ibuprofen 2×200 mg liquid capsules 3 times daily (TID, ibuprofen 2×200 mg tablets TID, FD-APAP 2×500 mg tablets 4 times daily (QID, and placebo 2×500 mg tablets QID for 7 days. The primary end point was gastric mucosal damage assessed by endoscopy using the Lanza scale: 0=normal stomach or proximal duodenum, 1=mucosal hemorrhages only, 2=1 or 2 erosions, 3=numerous (3–10 erosions, and 4=large number of erosions (>10 or ulcer. Secondary end points included duodenal mucosal damage (Lanza scale; gastroduodenal mucosal injury, classified as present (gastric and/or duodenal endoscopy score ≥2 or absent (gastric and/or duodenal endoscopy score <2; and number of hemorrhages, erosions, and ulcers counted separately in the stomach and duodenum. Results: Significantly greater gastric mucosal injury was observed after treatment with both ibuprofen products vs FD-APAP (p<0.0001 and p=0.0095, respectively. FD-APAP showed no difference from placebo (p=0.4794. The odds of having an incidence of gastroduodenal mucosal injury were over 6 times greater from FD ibuprofen liquid capsule treatment (odds ratio [OR]=6.19, 95% confidence interval [CI]: 1.60, 23.97 and over 3 times greater from ibuprofen

  5. 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 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 suggest that the potential of Kinect to reduce the energy gap underlying weight gain is offset within 24 h in

  6. Propranolol, clonidine, urapidil and trazodone infusion in essential tremor: a double-blind crossover trial.

    Science.gov (United States)

    Caccia, M R; Osio, M; Galimberti, V; Cataldi, G; Mangoni, A

    1989-05-01

    Accelerometric tremorgrams were recorded from 25 subjects affected by essential tremor and analysed by a Berg-Fourier frequency analyser before and during venous infusion of the following drugs: propranolol (beta-blocker), clonidine (alpha-presynaptic adrenergic agonist), urapidil (alpha-postsynaptic blocker), trazodone (adrenolytic agent) and placebo. The washout interval between infusions was 3 days. Recordings and data analyses were performed in a double-blind crossover trial. Tremor was classified as: at rest; postural (arms hyperextended); and intention (finger-nose test). Analysis of the results showed that propranolol and clonidine reduced significantly (P = 0.01 and P = 0.009, respectively) the power spectrum of postural tremor, but left at rest and intention tremors unchanged. No significant effects on the tremor power spectrum were observed after placebo, urapidil or trazodone administration. None of the drugs had any effect on tremor frequency.

  7. 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; Doyle, Francis J

    2016-07-01

    To evaluate two widely used control algorithms for an artificial pancreas (AP) under nonideal but comparable clinical conditions. 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. 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. © 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  8. Lack of functional benefit with glutamine versus placebo in Duchenne muscular dystrophy: a randomized crossover trial.

    Directory of Open Access Journals (Sweden)

    Elise Mok

    Full Text Available Oral glutamine decreases whole body protein breakdown in Duchenne muscular dystrophy (DMD. We evaluated the functional benefit of 4 months oral glutamine in DMD.30 ambulant DMD boys were included in this double-blind, randomized crossover trial with 2 intervention periods: glutamine (0.5 g/kg/d and placebo, 4 months each, separated by a 1-month wash-out, at 3 outpatient clinical investigation centers in France. Functional benefit was tested by comparing glutamine versus placebo on change in walking speed at 4 months. Secondary outcome measures were: 2-minute walk test, work, power, muscle mass (urinary creatinine, markers of myofibrillar protein breakdown (urinary 3-methyl-histidine/creatinine, serum creatine phospho-kinase, body composition (fat free mass, fat mass percentage, safety and oral nutrient intake. There was no improvement in the primary end point (walking speed or in secondary measures of muscle function (2-minute walk test, work, power in the glutamine group compared with placebo. However, subjects receiving glutamine or placebo showed no deterioration in functional measures over the course of the 9-month trial. No differences in muscle mass, markers of protein breakdown or serum creatine phosho-kinase were observed, except for a blunted increase in fat free mass in the glutamine group which led to a greater increase in fat mass percentage. Glutamine was safe and well-tolerated.This trial did not identify additional benefit of 4 months oral glutamine over placebo on muscle mass or function in ambulatory DMD boys. Although apparently safe, current data cannot support routine supplementation in this population as a whole, until further research proves otherwise.(ClinicalTrials.gov NCT00296621.

  9. 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.

  10. Postprandial changes in cardiometabolic disease risk in young Chinese men following isocaloric high or low protein diets, stratified by either high or low meal frequency - a randomized controlled crossover trial.

    Science.gov (United States)

    Mok, Alexander; Haldar, Sumanto; Lee, Jetty Chung-Yung; Leow, Melvin Khee-Shing; Henry, Christiani Jeyakumar

    2016-03-15

    Cardio-Metabolic Disease (CMD) is the leading cause of death globally and particularly in Asia. Postprandial elevation of glycaemia, insulinaemia, triglyceridaemia are associated with an increased risk of CMD. While studies have shown that higher protein intake or increased meal frequency may benefit postprandial metabolism, their combined effect has rarely been investigated using composite mixed meals. We therefore examined the combined effects of increasing meal frequency (2-large vs 6-smaller meals), with high or low-protein (40 % vs 10 % energy from protein respectively) isocaloric mixed meals on a range of postprandial CMD risk markers. In a randomized crossover study, 10 healthy Chinese males (Age: 29 ± 7 years; BMI: 21.9 ± 1.7 kg/m(2)) underwent 4 dietary treatments: CON-2 (2 large Low-Protein meals), CON-6 (6 Small Low-Protein meals), PRO-2 (2 Large High-Protein meals) and PRO-6 (6 Small High-Protein meals). Subjects wore a continuous glucose monitor (CGM) and venous blood samples were obtained at baseline and at regular intervals for 8.5 h to monitor postprandial changes in glucose, insulin, triglycerides and high sensitivity C-reactive protein (hsCRP). Blood pressure was measured at regular intervals pre- and post- meal consumption. Urine was collected to measure excretion of creatinine and F2-isoprostanes and its metabolites over the 8.5 h postprandial period. The high-protein meals, irrespective of meal frequency were beneficial for glycaemic health since glucose incremental area under the curve (iAUC) for PRO-2 (185 ± 166 mmol.min.L(-1)) and PRO-6 (214 ± 188 mmol.min.L(-1)) were 66 and 60 % lower respectively (both p meals with higher protein content, irrespective of meal frequency appears to be beneficial for postprandial glycemic and insulinemic responses in young, healthy Chinese males. Implications of this study may be useful in the Asian context where the consumption of high glycemic index, carbohydrate meals is prevalent. NCT02529228 .

  11. Effect of Low Concentrations of Apomorphine on Parkinsonism in a Randomized, Placebo-Controlled, Crossover Study

    Science.gov (United States)

    Gunzler, Steven A.; Koudelka, Caroline; Carlson, Nichole E.; Pavel, Misha; Nutt, John G.

    2011-01-01

    Objective To determine whether low concentrations of a dopamine agonist worsen parkinsonism, which would suggest that activation of presynaptic dopamine autoreceptors causes a super-off state. Design Randomized, double-blind, placebo-controlled, crossover clinical trial. Setting Academic movement disorders center. Patients Patients with Parkinson disease and motor fluctuations. Intervention Fourteen patients with Parkinson disease and motor fluctuations were randomized to receive 1 of 6 possible sequences of placebo, low-dose (sub-threshold) apomorphine hydrochloride, and high-dose (threshold to suprathreshold) apomorphine hydrochloride infusions. Subthreshold doses of apomorphine hydrochloride (12.5 μg/kg/h every 2 hours and 25 μg/kg/h every 2 hours), threshold to suprathreshold doses of apomorphine hydrochloride (50 μg/kg/h every 2 hours and 100 μg/kg/h every 2 hours), and placebo were infused for 4 hours daily for 3 consecutive days. Main Outcome Measures Finger and foot tapping rates. Results There was no decline in finger or foot tapping rates during the low-dose apomorphine hydrochloride infusions relative to placebo. The high-dose infusions increased foot tapping (P<.001) and trended toward increasing finger tapping compared with placebo infusions. Conclusions Subthreshold concentrations of apomorphine did not worsen parkinsonism, suggesting that pre-synaptic dopamine autoreceptors are not important to the motor response in moderate to advanced Parkinson disease. PMID:18268187

  12. Effects on peripheral and central blood pressure of cocoa with natural or high-dose theobromine: A randomized, double-blind crossover trial

    OpenAIRE

    Bogaard, Bas; Draijer, Richard; Westerhof, Berend; Meiracker, Anton; Montfrans, Gert; Born, B.J.H.

    2010-01-01

    textabstractFlavanol-rich cocoa products have been reported to lower blood pressure. It has been suggested that theobromine is partially responsible for this effect. We tested whether consumption of flavanol-rich cocoa drinks with natural or added theobromine could lower peripheral and central blood pressure. In a double-blind, placebo-controlled 3-period crossover trial we assigned 42 healthy individuals (age 62±4.5 years; 32 men) with office blood pressure of 130 to 159 mm Hg/85 to 99 mm Hg...

  13. Using sit-stand workstations to decrease sedentary time in office workers: a randomized crossover trial.

    Science.gov (United States)

    Dutta, Nirjhar; Koepp, Gabriel A; Stovitz, Steven D; Levine, James A; Pereira, Mark A

    2014-06-25

    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. 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. 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. The SSD intervention was successful in increasing work-time activity level, without changing activity level during non-work hours.

  14. 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.

  15. 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.

  16. Achy breaky makey wakey heart? A randomised crossover trial of musical prompts.

    Science.gov (United States)

    Woollard, Malcolm; Poposki, Jason; McWhinnie, Brae; Rawlins, Lettie; Munro, Graham; O'Meara, Peter

    2012-04-01

    Compared with no music (NM), does listening to 'Achy breaky heart' (ABH) or 'Disco science' (DS) increase the proportion of prehospital professionals delivering chest compressions at 2010 guideline-compliant rates of 100-120 bpm and 50-60 mm depths? A randomised crossover trial recruiting at an Australian ambulance conference. Volunteers performed three 1-min sequences of continuous chest compressions on a manikin accompanied by NM, repeated choruses of ABH and DS, prerandomised for order. 37 of 74 participants were men; median age 37 years; 61% were paramedics, 20% students and 19% other health professionals. 54% had taken cardiopulmonary resuscitation training within 1 year. Differences in compression rate (mode, IQR) were significant for NM (105, 99-116) versus ABH (120, 107-120) and DS (104, 103-107) versus ABH (p0.5). Listening to DS significantly increased the proportion of prehospital professionals compressing at 2010 guideline-compliant rates. Regardless of intervention more than half gave compressions that were too shallow. Alternative audible feedback mechanisms may be more effective.

  17. Exposure to bisphenol A from drinking canned beverages increases blood pressure: randomized crossover trial.

    Science.gov (United States)

    Bae, Sanghyuk; Hong, Yun-Chul

    2015-02-01

    Bisphenol A (BPA) is a chemical used in plastic bottles and inner coating of beverage cans, and its exposure is almost ubiquitous. BPA has been associated with hypertension and decreased heart rate variability in the previous studies. The aim of the present study was to determine whether increased BPA exposure from consumption of canned beverage actually affects blood pressure and heart rate variability. We conducted a randomized crossover trial with noninstitutionalized adults, who were aged ≥60 years and recruited from a local community center. A total of 60 participants visited the study site 3 times, and they were provided the same beverage in 2 glass bottles, 2 cans, or 1 can and 1 glass bottle at a time. The sequence of the beverage was randomized. We then measured urinary BPA concentration, blood pressure, and heart rate variability 2 hours after the consumption of each beverage. The paired t test and mixed model were used to compare the differences. The urinary BPA concentration increased after consuming canned beverages by >1600% compared with that after consuming glass bottled beverages. Systolic blood pressure adjusted for daily variance increased by ≈4.5 mm Hg after consuming 2 canned beverages compared with that after consuming 2 glass bottled beverages, and the difference was statistically significant. The parameters of the heart rate variability did not show statistically significant differences.The present study demonstrated that consuming canned beverage and consequent increase of BPA exposure increase blood pressure acutely. © 2014 American Heart Association, Inc.

  18. Cytopathology whole slide images and adaptive tutorials for postgraduate pathology trainees: a randomized crossover trial.

    Science.gov (United States)

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

    2015-09-01

    To determine whether cytopathology whole slide images and virtual microscopy adaptive tutorials aid learning by postgraduate trainees, we designed a randomized crossover trial to evaluate the quantitative and qualitative impact of whole slide images and virtual microscopy adaptive tutorials compared with traditional glass slide and textbook methods of learning cytopathology. Forty-three anatomical pathology registrars were recruited from Australia, New Zealand, and Malaysia. Online assessments were used to determine efficacy, whereas user experience and perceptions of efficiency were evaluated using online Likert scales and open-ended questions. Outcomes of online assessments indicated that, with respect to performance, learning with whole slide images and virtual microscopy adaptive tutorials was equivalent to using traditional methods. High-impact learning, efficiency, and equity of learning from virtual microscopy adaptive tutorials were strong themes identified in open-ended responses. Participants raised concern about the lack of z-axis capability in the cytopathology whole slide images, suggesting that delivery of z-stacked whole slide images online may be important for future educational development. In this trial, learning cytopathology with whole slide images and virtual microscopy adaptive tutorials was found to be as effective as and perceived as more efficient than learning from glass slides and textbooks. The use of whole slide images and virtual microscopy adaptive tutorials has the potential to provide equitable access to effective learning from teaching material of consistently high quality. It also has broader implications for continuing professional development and maintenance of competence and quality assurance in specialist practice. Copyright © 2015 Elsevier Inc. All rights reserved.

  19. 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.

  20. Fluoropolymer-coated dacron versus PTFE grafts for femorofemoral crossover bypass: randomised trial

    DEFF Research Database (Denmark)

    Eiberg, JP; Røder, Ole Christian; Stahl-Madsen, M

    2006-01-01

    To investigate whether patency of a thin walled 8 mm fluoropassivated Dacron graft was similar to that of a standard 8mm PTFE graft for femorofemoral crossover bypass surgery.......To investigate whether patency of a thin walled 8 mm fluoropassivated Dacron graft was similar to that of a standard 8mm PTFE graft for femorofemoral crossover bypass surgery....

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

    DEFF Research Database (Denmark)

    Jørgensen, Mette Rose; Keller, Mette Kirstine; Kragelund, Camilla

    2016-01-01

    Objectives: To evaluate the effect of daily ingestion of probiotic lactobacilli on the levels of secretory IgA (sIgA) and selected cytokines in whole saliva of healthy young adults. Materials and methods: The study group consisted of 47 healthy adults (18–32 years) who volunteered for a randomize....... reuteri do not seem to modulate the salivary oral immune response in healthy young subjects (ClinicalTrials.gov NCT02017886).......Objectives: To evaluate the effect of daily ingestion of probiotic lactobacilli on the levels of secretory IgA (sIgA) and selected cytokines in whole saliva of healthy young adults. Materials and methods: The study group consisted of 47 healthy adults (18–32 years) who volunteered for a randomized...... and 3 weeks post-intervention levels. No side- or adverse effects were reported. Conclusions: Supplementation with two strains of the probiotic L. reuteri did not affect sIgA or cytokine levels in whole saliva in healthy young adults. The results thereby indicate that daily oral supplementation with L...

  2. 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

    2018-01-01

    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.

  3. Memantine for prophylaxis of chronic tension-type headache--a double-blind, randomized, crossover clinical trial

    DEFF Research Database (Denmark)

    Lindelof, K; Bendtsen, L; Lindelof, K

    2009-01-01

    Treatment for chronic tension-type headache (CTTH) is unsatisfactory. Our aim was to investigate the efficacy of the N-methyl D-aspartate (NMDA) antagonist memantine in the prophylactic treatment of CTTH. We included 40 patients in a randomized, double-blind, placebo-controlled, crossover trial....... Memantine 20-40 mg/day or placebo was each given for 10 weeks separated by a 2-week wash-out period; 29 patients completed the study. The primary efficacy variable, area-under-the-headache curve (duration x intensity), did not differ between memantine (1352 +/- 927) and placebo (1449 +/- 976; P = 0.......10). Headache intensity in both sexes was significantly lower on a 0-10 verbal rating scale with memantine (3.8) than with placebo (4.1; P = 0.03). In women, area-under-the-headache curve was significantly lower with memantine (1343 +/- 919) than with placebo (1555 +/- 1019; P = 0.01). The most common side...

  4. Postprandial Effects of Breakfast Glycemic Index on Vascular Function among Young Healthy Adults: A Crossover Clinical Trial

    Directory of Open Access Journals (Sweden)

    Natalia Sanchez-Aguadero

    2017-07-01

    Full Text Available This study aimed to evaluate the postprandial effects of high and low glycemic index (GI breakfasts on vascular function. It was a crossover trial that included 40 young healthy adults (50% women, aged 20–40 years, who were recruited at primary care settings. They consumed three experimental breakfasts in randomized order, each one separated by a 1-week washout period: (1 control conditions (only water; (2 low GI (LGI breakfast (29.4 GI and 1489 KJ energy; and (3 high GI (HGI breakfast (64.0 GI and 1318 KJ energy. Blood samples were collected at 60 and 120 min after each breakfast to determine glucose and insulin levels. Vascular parameters were measured at 15 min intervals. Augmentation index (AIx was studied as a primary outcome. Secondary outcomes comprised glucose, insulin, heart rate (HR and pulse pressures (PPs. We found a trend toward increased AIx, HR and PPs for the HGI versus the LGI breakfast. A significant interaction between the type of breakfast consumed and all measured parameters was identified (p < 0.05 except for central PP. Stratifying data by sex, this interaction remained significant for AIx and augmentation pressure only in males (p < 0.05. In conclusion, breakfast GI could affect postprandial vascular responses in young healthy adults.

  5. 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.

  6. A Mixture of 3 Bifidobacteria Decreases Abdominal Pain and Improves the Quality of Life in Children With Irritable Bowel Syndrome: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Trial.

    Science.gov (United States)

    Giannetti, Eleonora; Maglione, Marco; Alessandrella, Annalisa; Strisciuglio, Caterina; De Giovanni, Donatella; Campanozzi, Angelo; Miele, Erasmo; Staiano, Annamaria

    2017-01-01

    We assessed the efficacy of a probiotic mixture of Bifidobacterium infantis M-63, breve M-16V, and longum BB536 in improving abdominal pain (AP) and quality of life (QoL) in children with irritable bowel syndrome (IBS) and functional dyspepsia (FD). AP-associated functional gastrointestinal disorders, particularly IBS and FD, are common in pediatrics, and no well-established treatment is currently available. Although probiotics have shown promising results in adults, data in children are heterogeneous. Forty-eight children with IBS (median age, 11.2 y; range, 8 to 17.9 y) and 25 with FD (age, 11.6 y; range, 8 to 16.6 y) were randomized to receive either a mixture of 3 Bifidobacteria or a placebo for 6 weeks. After a 2-week "washout" period, each patient was switched to the other group and followed up for further 6 weeks. At baseline and follow-up, patients completed a symptom diary and a QoL questionnaire. AP resolution represented the primary outcome parameter. In IBS, but not in FD, Bifidobacteria determined a complete resolution of AP in a significantly higher proportion of children, when compared with placebo (P=0.006), and significantly improved AP frequency (P=0.02). The proportion of IBS children with an improvement in QoL was significantly higher after probiotics than after placebo (48% vs. 17%, P=0.001), but this finding was not confirmed in FD. In children with IBS a mixture of Bifidobacterium infantis M-63, breve M-16V, and longum BB536 is associated with improvement in AP and QoL. These findings were not confirmed in FD subjects. Trial identifier: NCT02566876 (http://www.clinicaltrial.gov).

  7. A randomized, controlled, crossover study of appetite-related sensations after consuming snacks made from buckwheat.

    Science.gov (United States)

    Defries, Danielle M; Petkau, Jay C; Gregor, Terri; Blewett, Heather

    2018-02-01

    With the rising incidence of overweight and obesity in developed countries, there is an interest in developing food products that may aid in satiety and reduce energy intake. Buckwheat (Fagopyrum esculentum) is a gluten-free edible seed that has been previously shown to induce changes in postprandial concentrations of satiety hormones; however, subjective measures of appetite-related sensations and objective measures of energy intake at subsequent meals following buckwheat consumption have not been measured. Thirty-eight healthy adults were recruited to participate in a randomized, controlled, crossover trial with the main objective to determine if consuming snacks made from buckwheat would increase satiety and reduce energy intake compared with snacks comparable in serving size, physical characteristics, and nutrient composition. Water was included as a no-kilocalorie control. Participants received each of the treatments once separated by at least 7 days. Appetite related sensations were assessed using visual analog scales at fasting and after consuming the snack at 30-min intervals for 180 min. Lunch was provided at the clinic and the amount of food consumed was weighed. Participants recorded food intake for the rest of the day. Consuming buckwheat groats (32 g serving; 141 kcal) or pita bread made from buckwheat flour (50 g serving; 135 kcal) was not associated with changes in appetite related sensations or energy consumption compared with reference snack products made from corn or rice flour. Sensory questionnaires revealed that snacks made from buckwheat were liked to a similar degree or more as reference snack products, which shows commercial promise for developing buckwheat-containing snacks.

  8. Consumption of red-hot chili pepper increases symptoms in patients with acute anal fissures. A prospective, randomized, placebo-controlled, double blind, crossover trial Efeito da pimenta vermelha nos sintomas de pacientes com fissuras anais agudas

    Directory of Open Access Journals (Sweden)

    Pravin J. Gupta

    2008-06-01

    Full Text Available BACKGROUND: Red-hot chili pepper and other spices have been blamed for causing or exacerbating symptoms of anal pathologies like anal fissure and hemorrhoids. AIM: To determine if consumption of chilies increases symptoms of acute anal fissures. METHODS: Individual patients were randomized to receive capsules containing chili or placebo for one week in addition to analgesics and fiber supplement. Patients were asked to note score for symptoms like pain, anal burning, and pruritus during the study period. After 1 week, cross over treatment was administered to the same group of patients with the same methodology and results were noted at the end of 2 weeks. RESULTS: Fifty subjects were recruited for this study. Forty three of them completed the trial (22 in the chili group and 21 in the placebo group. The daily mean pain score was significantly lower in the placebo group in the study period. Score 2.05 in chili group and 0.97 in placebo group. There was a significant burning sensation experienced by the patients in the chili group (score 1.85 for the chili group vs 0.71 for the placebo group. Patient’s mean recorded improvement score was significantly higher after taking placebo. Eighty one point three percent patients preferred placebo while 13.9% preferred chilies. Two patients had no preference. CONCLUSION: Consumption of chili does increase the symptoms of acute anal fissure and reduces patient compliance.RACIONAL: A pimenta vermelha e outras especiarias têm sido responsabilizadas por agravar a sintomatologia das doenças anais, tais como fissuras e hemorróidas. OBJETIVO: Determinar se o consumo de pimentas vermelhas aumentaria os sintomas em fissuras anais agudas. MÉTODOS: Pacientes foram recrutados e randomizados para receber cápsulas contendo pimenta ou placebos por 1 semana, somadas a analgésicos e suplementos de fibras. Foi solicitado que anotassem um escore de sintomas, tais como dor, queimação anal, prurido durante o per

  9. Sensory Barrage Stimulation in the Treatment of Elbow Spasticity: A Crossover Double Blind Randomized Pilot Trial.

    Science.gov (United States)

    Slovak, Martin; Chindo, Joseph; Nair, Krishnan Padmakumari Sivaraman; Reeves, Mark L; Heller, Ben; Barker, Anthony T

    2016-02-01

    To assess the feasibility of using a novel form of multichannel electrical stimulation, termed Sensory Barrage Stimulation (SBS) for the treatment of spasticity affecting the elbow flexor muscles and to compare this with conventional single-channel TENS stimulation. Altogether ten participants with spasticity of the flexor muscles of the elbow of Grade 2 or above on the Modified Ashworth Scale (MAS) were recruited to this crossover double blind randomized trial. The participants received two intervention sessions (SBS and TENS), one week apart in a randomized order. Both interventions were applied over the triceps brachii on the affected arm for a duration of 60 minutes. Spasticity was measured using the MAS. Secondary outcome measures were self-reported change in spasticity, measured on a visual analog scale (VAS, 0-100), and therapist-rated strength of elbow extension and strength of elbow flexion. Measurements were taken immediately before each intervention was applied, immediately after the intervention, and one hour after the intervention. Immediately after stimulation spasticity showed a significant reduction for both TENS and SBS groups assessed by MAS -0.9 ± 0.2 vs. -1.1 ± 0.2 and by VAS -15 ± 3 vs. -31 ± 8. For SBS this improvement in MAS was still present at one hour after the stimulation, but not for TENS. Altogether seven SBS responders and four TENS responders were identified. This study demonstrates the feasibility and practicality of applying the new concept of SBS. Promising results indicate it causes a reduction in spasticity. © 2015 International Neuromodulation Society.

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

    Science.gov (United States)

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

    2015-06-01

    New methods of teaching and learning are constantly being sought in the adult learning environment. Audience Response Systems (ARS) have been used in many different learning environments, especially in the field of medical education. The objective of this investigation was to ascertain the effect of ARS use in undergraduate teaching in a UK dental school. A cross-over clustered randomized educational trial. Leeds Dental Institute. Year 4 undergraduate dental students in orthodontics. Students at Leeds Dental Institute were taught two different topics within the curriculum to test the use of ARS in a cross-over trial. A questionnaire was delivered to the test (ARS) and control (non-ARS) groups. The response rate to the questionnaires was 89·5% (test group) and 82·9% (control group). The ARS enabled students to perform better as shown by knowledge retention (P = 0·013). Students found the seminar more interesting (P = 0·013), easier to concentrate (P = 0·025) and easier to participate in (P = 0·020) when ARS was used. When ARS was used, students were more able to answer questions (P<0·0001), were more likely to prepare for the seminar (P<0·0001) and significantly preferred using ARS (P<0·0001). ARS was found to significantly improve student concentration and participation in small group seminar teaching and significantly improved knowledge retention. ARS may be useful in facilitating orthodontic teaching in the future.

  11. Cluster-Randomized, Crossover Trial of Head Positioning in Acute Stroke.

    Science.gov (United States)

    Anderson, Craig S; Arima, Hisatomi; Lavados, Pablo; Billot, Laurent; Hackett, Maree L; Olavarría, Verónica V; Muñoz Venturelli, Paula; Brunser, Alejandro; Peng, Bin; Cui, Liying; Song, Lily; Rogers, Kris; Middleton, Sandy; Lim, Joyce Y; Forshaw, Denise; Lightbody, C Elizabeth; Woodward, Mark; Pontes-Neto, Octavio; De Silva, H Asita; Lin, Ruey-Tay; Lee, Tsong-Hai; Pandian, Jeyaraj D; Mead, Gillian E; Robinson, Thompson; Watkins, Caroline

    2017-06-22

    The role of supine positioning after acute stroke in improving cerebral blood flow and the countervailing risk of aspiration pneumonia have led to variation in head positioning in clinical practice. We wanted to determine whether outcomes in patients with acute ischemic stroke could be improved by positioning the patient to be lying flat (i.e., fully supine with the back horizontal and the face upwards) during treatment to increase cerebral perfusion. In a pragmatic, cluster-randomized, crossover trial conducted in nine countries, we assigned 11,093 patients with acute stroke (85% of the strokes were ischemic) to receive care in either a lying-flat position or a sitting-up position with the head elevated to at least 30 degrees, according to the randomization assignment of the hospital to which they were admitted; the designated position was initiated soon after hospital admission and was maintained for 24 hours. The primary outcome was degree of disability at 90 days, as assessed with the use of the modified Rankin scale (scores range from 0 to 6, with higher scores indicating greater disability and a score of 6 indicating death). The median interval between the onset of stroke symptoms and the initiation of the assigned position was 14 hours (interquartile range, 5 to 35). Patients in the lying-flat group were less likely than patients in the sitting-up group to maintain the position for 24 hours (87% vs. 95%, P<0.001). In a proportional-odds model, there was no significant shift in the distribution of 90-day disability outcomes on the global modified Rankin scale between patients in the lying-flat group and patients in the sitting-up group (unadjusted odds ratio for a difference in the distribution of scores on the modified Rankin scale in the lying-flat group, 1.01; 95% confidence interval, 0.92 to 1.10; P=0.84). Mortality within 90 days was 7.3% among the patients in the lying-flat group and 7.4% among the patients in the sitting-up group (P=0.83). There were

  12. 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.

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

    Science.gov (United States)

    Nourbakhsh, Bardia; Revirajan, Nisha; Waubant, Emmanuelle

    2018-01-01

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

  14. Comparative crossover controlled study using poly sulphone and Vitamin E coated dialyzers

    International Nuclear Information System (INIS)

    Al-Jonderby, Mohammad S.; Cabaguing, IoIani; Pajarillo, Amillata A.

    2003-01-01

    There is relatively little clinical experience reported on the use of vitamin E coated dialyzer (CL-EE 12, Terumo). This study compares its efficacy and intradialytic symptoms with a poly sulphone dialyzer in 2 group of patients in a controlled crossover trial design. This study was carried out at at Armed Forces Hospital, Riyadh, Kingdom of Saudi Arabia, during time period from January to March 2002. In group A, 34 patients were dialyzed for 4 weeks with vitamin E dialyzer and then switched over to Fresenius 60 ( F60)for 4 weeks .In group B, 41 patients were dialyzed with F60 for 4 weeks then switched over to vitamin E coated dialyzers for 4 weeks .The following parameters were measured weekly ,hemoglobin level ,urea reduction ratio (URR), urea clarence ratio (Kt/V), pre and post dialysis diastolic blood pressure (DBP)and diastolic blood pressure (DBP), interdialytic weight gain. The patients were observed for interdialytic hypertension or symptoms.No significant findings were found in any of the parameters except more dialyzer clotting was observed with vitamin E dialyzer than in F60 dialyzers(1.6%of dialysis sessions versus 0.1% P<0.03).The interdialytic weight gain tended to be less in vitamin E group but did not reach statistically significant difference.The Kt / V and URR were slightly higher when using vitamin E dialyzer only in the second and third weeks hypotensive episodes( P<,007)less leg cramp (P<.31) and less itching (P<,0.2) in the vitamin E coated treated group within group. There were only minor differences noted between between the 2 dialyzers in the parameters measured. (author)

  15. Dairy consumption and cardiometabolic health: outcomes of a 12-month crossover trial

    Directory of Open Access Journals (Sweden)

    Crichton Georgina E

    2012-03-01

    Full Text Available Abstract Background A growing body of research suggests that regular consumption of dairy foods may counteract obesity and other components of the metabolic syndrome. However, human intervention trials are lacking. We aimed to determine the cardiometabolic health effects of increasing the consumption of reduced fat dairy foods in adults with habitually low dairy intakes in the absence of energy restriction. Methods An intervention trial was undertaken in 61 overweight or obese adults who were randomly assigned to a high dairy diet (HD, 4 serves of reduced fat dairy/day or a low dairy control diet (LD, ≤1 serve/day for 6 months then crossed over to the alternate diet for a further 6 months. A range of anthropometric and cardiometabolic parameters including body composition, metabolic rate, blood lipids, blood pressure and arterial compliance were assessed at the end of each diet phase. Results Total energy intake was 1120 kJ/day higher during the HD phase, resulting in slight weight gain during this period. However, there were no significant differences between HD and LD in absolute measures of waist circumference, body weight, fat mass or any other cardiometabolic parameter. Conclusion Recommended intakes of reduced fat dairy products may be incorporated into the diet of overweight adults without adversely affecting markers of cardiometabolic health. Trial Registration The trial was registered with the Australia and New Zealand Clinical Trials Registry (ACTRN12608000538347 on 24th October, 2008.

  16. Effect of Persian Medicine Remedy on Chemotherapy Induced Nausea and Vomiting in Breast Cancer: A Double Blind, Randomized, Crossover Clinical Trial

    Science.gov (United States)

    Nazari, Mohammad; Taghizadeh, Ali; Bazzaz, Mojtaba Mousavi; Rakhshandeh, Hassan; Shokri, Sadegh

    2017-01-01

    Background Chemotherapy induced nausea and vomiting (CINV) is a side effect, and has negative effect on quality of life and continuation of chemotherapy. Despite new regimen and drugs, the problems still remain and standard guidelines, effective treatment and supportive care for refractory CINV are still not yet established. Persian medicine, the old Iranian medical school, offer Persumac (prepared from Rhus Coriaria and Bunium Persicum Boiss). Objective The specific objectives were to assess the effect of Persumac on the number and severity of nausea and vomiting in refractory CINV in acute and delayed phase. Methods This randomized, double blind, crossover clinical trial study was carried out on 93 patients with breast cancer and refractory CINV, who received outpatient high emetogenic chemotherapy in Imam Reza hospital, Mashhad, Iran from October 2015 to May 2016. The study has three stages: in stage I patients received a questionaire and completed it after chemotherapy. In stage II they were randomly divided into intervention group with Persumac and control group with placebo (lactose were used). In stage III, wash out and crossover was conducted. Both groups in all stages received standard antiemetic therapy for CINV. The following were set as the inclusion criteria of the study: female, Age ≥18 years, clinical diagnosis of breast cancer, history of refractory CINV, normal blood tests and at least three courses of chemotherapy remaining. Exclusion criteria of this study were: Total or upper abdominal radiation therapy along with chemotherapy, drugs/therapy for nausea and vomiting not prescribed in this study, hypersensitivity to Sumac or Bunium Persicum, use of sumac and Bunium Persicum in seven days prior to the intervention, clinical diagnosis of digestion disorders, non-chemotherapy induced nausea and vomiting, milk allergy, loss of two consecutive or three intermittent doses of Persumac or placebo. Outcomes were gathered by Persian questionnaire. Number

  17. Anti-hyperglycaemic effects of herbal porridge made of Scoparia dulcis leaf extract in diabetics - a randomized crossover clinical trial.

    Science.gov (United States)

    Senadheera, Senadheera Pathirannehelage Anuruddhika Subhashinie; Ekanayake, Sagarika; Wanigatunge, Chandanie

    2015-11-19

    Leaf extracts of Scoparia dulcis, is used as a herbal remedy by diabetics worldwide. Fresh Scoparia dulcis porridge elicited a low glycaemic index (GI) and anti-hyperglycaemic effects when fed to diabetic Wistar rats. Commercially produced Scoparia dulcis porridge (SDC) elicited medium GI. Present study was aimed at studying the anti-diabetic effects of consumption of commercially produced S. dulcis porridge. A randomized crossover clinical trial with type 2 diabetic patients (n = 35) on medication, with mild and moderate diabetes [fasting blood glucose (FBG) 126-300 mg/dL, age 35-70 years] was conducted. Within the first three months (study period 1) group 1 was the test and group 2 was the control. Following a wash-out period, the two groups were crossed over (study period 2: group 1 - control; group 2 - test). Test group consumed commercially produced SDC for 3 days/week for three months and the control group any other food. At the onset and end of each study period glucose measurements [Fasting Blood Glucose (FBG), HbA1c], lipid measurements (total cholesterol, HDL-C, LDL-C, triglycerides, cholesterol ratios), toxicity parameters (liver enzymes, creatinine, CRP, eGFR) were analyzed by enzyme assay kit methods using a KONELAB 20XT auto analyzer. Significances between groups were analyzed by one way ANOVA (normal distribution) and Mann Whitney test (if the values were not normally distributed). Within group comparisons were carried out by Bonferroni post hoc test. During the crossover clinical trial HbA1c of group 1 decreased from 7.9 ± 0.5 to 6.5 ± 0.3 (p = 0.003) while HbA1c of group 2 decreased from 7.0 ± 0.3to 6.7 ± 0.3 while in the test group. Therefore, both test groups (1 and 2) elicited a decrease in HbA1c compared to respective control groups. Both test groups elicited a non significant decrease in FBG following the intervention (group 1 - from 174 ± 14 to 160 ± 10 mg/dL; group 2 - from 183 ± 13 to 160 ± 7 mg/dL). No significant differences (p >0

  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

    as baseline characteristics of two human intervention studies, within the Gut, Grain and Greens (3G) Center, investigating the effects of a gluten-poor and wholegrain-rich diet on microbiota composition and metabolic health. Design: The gluten and wholegrain studies had a randomized, controlled, cross......-over design each comprising two eight-week dietary intervention periods, separated by a six-week wash-out period. Each trial included 60 men and women exhibiting an increased metabolic risk. In the gluten study a gluten-poor diet was compared with a gluten-rich dietary fiber-controlled diet......, and in the wholegrain study a wholegrain-rich diet was compared with a refined grain diet. The control diet was identical in both studies, being concomitantly high in gluten and refined. Participants substituted all cereal products with provided intervention products which they consumed ad libitum. Before and after...

  19. Autoregulation of glomerular filtration rate during spironolactone treatment in hypertensive patients with type 1 diabetes: a randomized crossover trial

    DEFF Research Database (Denmark)

    Schjoedt, K.J.; Christensen, P.K.; Jorsal, A.

    2009-01-01

    if spironolactone affects the ability to autoregulate GFR. METHODS: Sixteen hypertensive type 1 diabetic patients with persistent normoalbuminuria (presumed normal autoregulation) completed this randomized, double-masked, crossover trial. After a 4-week wash-out period, patients received spironolactone 25 mg o...... correlated with diabetes duration (R = 0.67, P type 1 diabetic patients with normoalbuminuria. Our data......BACKGROUND: Autoregulation of GFR, i.e. maintenance of relative constancy of GFR despite variations in mean arterial pressure (MAP) >80 mmHg, is impaired in diabetic kidney disease; furthermore, some antihypertensive drugs may jeopardize autoregulation. The aim of our study was to establish...

  20. Effect of lingual nerve block on burning mouth syndrome (stomatodynia): a randomized crossover trial.

    Science.gov (United States)

    Grémeau-Richard, Christelle; Dubray, Claude; Aublet-Cuvelier, Bruno; Ughetto, Sylvie; Woda, Alain

    2010-04-01

    Burning mouth syndrome (stomatodynia) is associated with changes of a neuropathic nature the main location of which, peripheral or central, remains unknown. A randomised, double-blind crossover design was used to investigate the effects of lingual nerve block on spontaneous burning pain and a possible correlation with the effects of topical clonazepam, the patient's response to a psychological questionnaire, and the taste and heat thresholds. The spontaneous burning was measured with a visual analogue scale (VAS) just before and 15 min after injection. The decreases in VAS score after lidocaine or saline injection were not significantly different (2.7+/-3.9 and 2.0+/-2.6, respectively; n=20). However, two groups of patients could be identified: in a "peripheral group" (n=10) the VAS decrease due to lingual nerve injection was 4.3+/-3.1cm after lidocaine and 0.9+/-0.3 cm after saline (p=0.02). In a "central group" (n=7), there were an increase in pain intensity score (-0.8+/-2.6 cm) after lidocaine and a decrease (1.5+/-3.0 cm) after saline (p=0.15). An increase in the hospital anxiety and depression (HAD) score and a decreased taste sensitivity and heat pain threshold of painful oral area were seen in patients compared with age-and-sex-matched controls (p<0.05). Topical clonazepam treatment tended to be more effective (p=0.07) and HAD score lower (p<0.03) in the peripheral than in the central group. These results suggest that the neuropathic disorder associated with stomatodynia may be predominantly peripheral, central or mixed depending on the individual. Topical application of clonazepam and HAD may serve as indicators of which mechanism is dominating. Copyright 2009 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

  1. Double-blind crossover trial of trimethoprim-sulfamethoxazole in spinocerebellar ataxia type 3/Machado-Joseph disease.

    Science.gov (United States)

    Schulte, T; Mattern, R; Berger, K; Szymanski, S; Klotz, P; Kraus, P H; Przuntek, H; Schöls, L

    2001-09-01

    To evaluate the efficiency of a combination of trimethoprim and sulfamethoxazole in patients with spinocerebellar ataxia type 3/Machado-Joseph disease (SCA3/MJD). Placebo-controlled, double-blind crossover trial in 22 patients with genetically confirmed SCA3/MJD. Study phases of 6 months were separated by a washout period of 4 weeks. Dosages were a combination of trimethoprim, 160 mg, and sulfamethoxazole, 800 mg, twice daily for 2 weeks, followed by a combination of trimethoprim, 80 mg, and sulfamethoxazole, 400 mg, twice daily for 5.5 months. Outpatient department of the Neurological Clinic, Ruhr-University, Bochum, Germany. Ataxia ranking scale, self-assessment score, static posturography, and results of motor performance testing. Effects on the visual system were studied using the achromatic Vision Contrast Test System and the Farnsworth-Munsell 100-hue test for color discrimination. Physical and mental health were documented using the Medical Outcomes Study 36-Item Short-Form Health Survey. Subgroup analyses assessed the influence of age, sex, age at onset, duration of the disease, phenotype, and CAG repeat length on test performance. Twenty of 22 patients completed the study. Dropouts were due to a rash (placebo phase) and an attempted suicide in a family conflict. Trimethoprim-sulfamethoxazole therapy had no significant effect in SCA3/MJD patients in the short-term analysis (2 weeks) or in the long-term interval (6 months). In contrast to previous reports that studied smaller groups of patients, treatment with trimethoprim-sulfamethoxazole did not improve the diverse and complex movement disorders caused by SCA3/MJD. Trimethoprim-sulfamethoxazole had no effect on the visual system and cannot be recommended as a continuous treatment for SCA3/MJD patients.

  2. 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

  3. 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.

  4. 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.

  5. Tic Reduction with Risperidone Versus Pimozide in a Randomized, Double-Blind, Crossover Trial

    Science.gov (United States)

    Gilbert, Donald L.; Batterson, J. Robert; Sethuraman, Gopalan; Sallee, Floyd R.

    2004-01-01

    Objective: To compare the tic suppression, electrocardiogram (ECG) changes, weight gain, and side effect profiles of pimozide versus risperidone in children and adolescents with tic disorders. Method: This was a randomized, double-blind, crossover (evaluable patient analysis) study. Nineteen children aged 7 to 17 years with Tourette's or chronic…

  6. 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 ...

  7. Effects of pistachio nut supplementation on blood glucose in patients with type 2 diabetes: a randomized crossover trial.

    Science.gov (United States)

    Parham, Mahmoud; Heidari, Saeide; Khorramirad, Ashraf; Hozoori, Mohammad; Hosseinzadeh, Fatemeh; Bakhtyari, Lida; Vafaeimanesh, Jamshid

    2014-01-01

    Diabetes is a chronic, potentially debilitating, and often fatal disease. Dietary strategies to reduce postprandial glycemia are important in the prevention and treatment of diabetes. Nuts are rich in mono- and polyunsaturated fatty acids, which may reduce hyperglycemia and improve metabolism. To evaluate the effectiveness of pistachio nut supplementation on glycemic and inflammatory measures in patients with type 2 diabetes. In this double-blind, randomized, placebo-controlled, crossover trial, 48 diabetic patients were equally assigned to groups A and B. Patients in group A received a snack of 25 g pistachio nuts twice a day for 12 weeks and group B received a control meal without nuts. After 12 weeks of intervention, the patients had an 8-week washout. Then the groups were displaced, and group B received the same amount of pistachios for 12 weeks. With respect to the total change in variables over both phases, there was a marked decrease in HbA1c (-0.4%) and fasting blood glucose (FBG) concentrations (-16 mg/dl) in the pistachio group compared with the control group (p ≤ 0.001 for both). There was no overall significant change in BMI, blood pressure, HOMA-IR, and C-reactive protein (CRP) concentrations. Analysis of the two phases separately showed a decrease in FBG by 14 mg/dl and in HbA1c by 0.45% in the treatment group (A) after 12 weeks, while no significant differences were seen in group B (control group). In the second phase, FBG decreased from 151.36 ± 39.22 to 137.28 ± 28.65 mg/dl (-14 mg/dl) and HbA1c decreased from 7.42 ± 0.97 to 7.15 ± 0.68 mg/dl (-0.28%, p = 0.013 and p = 0.033, respectively) in the pistachio group (B). Pistachio consumption reduced systolic blood pressure (p = 0.007), BMI (p = 0.011), and CRP (p = 0.002) in patients from the treatment groups, but not insulin resistance. Dietary consumption of pistachio nuts as a snack has beneficial effects on glycemic control, blood pressure, obesity, and inflammation markers in diabetic

  8. 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

  9. 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 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.

  10. A Crossover Design for Comparative Efficacy: A 36-Week Randomized Trial of Bevacizumab and Ranibizumab for Diabetic Macular Edema.

    Science.gov (United States)

    Wiley, Henry E; Thompson, Darby J S; Bailey, Clare; Chew, Emily Y; Cukras, Catherine A; Jaffe, Glenn J; Lee, Richard W J; Loken, Erin K; Meyerle, Catherine B; Wong, Wai; Ferris, Frederick L

    2016-04-01

    To investigate the comparative efficacy of bevacizumab (Avastin) and ranibizumab (Lucentis; both Genentech, Inc, South San Francisco, CA) for diabetic macular edema (DME) using a crossover study design. Randomized, double-masked, 36-week, 3-period crossover clinical trial. Fifty-six subjects with DME involving the center of the macula in one or both eyes. Monthly intravitreous injections of bevacizumab (1.25 mg) or ranibizumab (0.3 mg). Comparison of mean changes in visual acuity and central retinal thickness, tested using a linear mixed-effects model. Based on the linear mixed-effects model, the 3-month estimated mean improvement in visual acuity was 5.3 letters for bevacizumab and 6.6 letters for ranibizumab (difference, 1.3 letters; P = 0.039). Estimated change in optical coherence tomography (OCT) central subfield mean thickness (CSMT) was -89 μm for bevacizumab and -137 μm for ranibizumab (difference, 48 μm; P < 0.001). Incorporating cumulative treatment benefit, the model yielded a predicted 36-week (9-month) average improvement in visual acuity of 7.1 letters (95% confidence interval [CI], 5.0-9.2) for bevacizumab and 8.4 letters (95% CI, 6.3-10.5) for ranibizumab, and a change in OCT CSMT of -128 μm (95% CI, -155 to -100) for bevacizumab and -176 μm (95% CI, -202 to -149) for ranibizumab. There was no significant treatment-by-period interaction (i.e., treatment difference was constant in all 3 periods), nor was there a significant differential carryover effect from one period to the next. This trial demonstrated a statistically significant but small relative clinical benefit of ranibizumab compared with bevacizumab for treatment of DME, using a markedly reduced sample size relative to a full comparative efficacy study. The effects on visual acuity and central retinal thickness for the 2 drugs are consistent with those reported at 1 year for the concurrent parallel-group trial by the Diabetic Retinopathy Clinical Research Network testing bevacizumab

  11. Music exposure and maturation of late preterm sleep-wake cycles: a randomised crossover trial.

    Science.gov (United States)

    Stokes, Adia; Agthe, Alexander G; El Metwally, Dina

    2018-04-01

    To determine the effect of music on sleep-wake cycle (SWC) patterns in late preterm neonates. In a masked crossover study, infants between 32 and 36 6/7 weeks gestation were randomised to music exposure either during the first six or last six hours of a 12-hour observation period. SWC characteristics were determined by continuous amplitude-integrated electroencephalography (aEEG) read by two coders masked to exposure sequence. Analysis was performed in paired comparisons. ANOVA was used to assess the effects of music exposure, period and crossover on SWC outcomes: (i) Burdjalov Scores (BS) during active sleep (AS) (ii) per cent and duration of quiet sleep (QS). Thirty infants were studied. A total of 222 QS cycles (median seven per patient; range five to 12) were analysed. Music exposure was associated with higher BS (F = 10.60, p = 0.0019) in AS and decreased interruptions during QS. The advanced postconceptual age (PCA) SWC pattern during AS was equivalent to a one-week mean. Number, duration and ratio of QS cycles did not change with music exposure. Music exposure elicits an increasing PCA pattern in AS and fewer interruptions in QS. Music may benefit sleep in late preterm infants. ©2017 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

  12. Effect of cessation of GH treatment on cognition during transition phase in Prader-Willi syndrome: results of a 2-year crossover GH trial

    Directory of Open Access Journals (Sweden)

    R. J. Kuppens

    2016-11-01

    Full Text Available Abstract Background Patients with Prader-Willi syndrome (PWS have a cognitive impairment. Growth hormone (GH treatment during childhood improves cognitive functioning, while cognition deteriorates in GH-untreated children with PWS. Cessation of GH treatment at attainment of adult height (AH might deteriorate their GH-induced improved cognition, while continuation might benefit them. We, therefore, investigated the effects of placebo versus GH administration on cognition in young adults with PWS who were GH-treated for many years during childhood and had attained AH. Method Two-year, randomized, double-blind, placebo-controlled cross-over study in 25 young adults with PWS. Cross-over intervention with placebo and GH (0.67 mg/m2/day, both during 1 year. Results Total (TIQ, verbal (VIQ and performance IQ (PIQ did not deteriorate during 1 year of placebo, compared to GH treatment (p > 0.322. Young adults with a lower TIQ had significantly more loss of TIQ points during placebo versus GH, in particular VIQ decreased more in those with a lower VIQ. The effect of placebo versus GH on TIQ, VIQ and PIQ was not different for gender or genotype. Conclusions Compared to GH treatment, 1 year of placebo did not deteriorate cognitive functioning of GH-treated young adults with PWS who have attained AH. However, patients with a lower cognitive functioning had more loss in IQ points during placebo versus GH treatment. The reassuring finding that 1 year of placebo does not deteriorate cognitive functioning does, however, not exclude a gradual deterioration of cognitive functioning on the long term. Trial registration ISRCTN24648386 , NTR1038 , Dutch Trial Register, www.trialregister.nl . Registered 16 August 2007.

  13. Cardiovascular benefits from ancient grain bread consumption: findings from a double-blinded randomized crossover intervention trial.

    Science.gov (United States)

    Sereni, Alice; Cesari, Francesca; Gori, Anna Maria; Maggini, Niccolò; Marcucci, Rossella; Casini, Alessandro; Sofi, Francesco

    2017-02-01

    Ancient grain varieties have been shown to have some beneficial effects on health. Forty-five clinically healthy subjects were included in a randomized, double-blinded crossover trial aimed at evaluating the effect of a replacement diet with bread derived from ancient grain varieties versus modern grain variety on cardiovascular risk profile. After 8 weeks of intervention, consumption of bread obtained by the ancient varieties showed a significant amelioration of various cardiovascular parameters. Indeed, the ancient varieties were shown to result in a significant reduction of total cholesterol, low-density lipoprotein (LDL)-cholesterol and blood glucose, whereas no significant differences during the phase with the modern variety were reported. Moreover, a significant increase in circulating endothelial progenitor cells were reported after the consumption of products made from the ancient "Verna" variety. The present results suggest that a dietary consumption of bread obtained from ancient grain varieties was effective in reducing cardiovascular risk factors.

  14. 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

    2009-01-01

    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 leather splint compared to the commercially available splint. Conclusion Leather wrist splints were superior to a commercially available fabric splint for the short-term relief of pain and dysfunction. PMID:19843345

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

    DEFF Research Database (Denmark)

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

    2017-01-01

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

  16. A Case Study of Controlling Crossover in a Selection Hyper-heuristic Framework Using the Multidimensional Knapsack Problem.

    Science.gov (United States)

    Drake, John H; Özcan, Ender; Burke, Edmund K

    2016-01-01

    Hyper-heuristics are high-level methodologies for solving complex problems that operate on a search space of heuristics. In a selection hyper-heuristic framework, a heuristic is chosen from an existing set of low-level heuristics and applied to the current solution to produce a new solution at each point in the search. The use of crossover low-level heuristics is possible in an increasing number of general-purpose hyper-heuristic tools such as HyFlex and Hyperion. However, little work has been undertaken to assess how best to utilise it. Since a single-point search hyper-heuristic operates on a single candidate solution, and two candidate solutions are required for crossover, a mechanism is required to control the choice of the other solution. The frameworks we propose maintain a list of potential solutions for use in crossover. We investigate the use of such lists at two conceptual levels. First, crossover is controlled at the hyper-heuristic level where no problem-specific information is required. Second, it is controlled at the problem domain level where problem-specific information is used to produce good-quality solutions to use in crossover. A number of selection hyper-heuristics are compared using these frameworks over three benchmark libraries with varying properties for an NP-hard optimisation problem: the multidimensional 0-1 knapsack problem. It is shown that allowing crossover to be managed at the domain level outperforms managing crossover at the hyper-heuristic level in this problem domain.

  17. 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 pea components as value-added ingredients in foods designed to improve glycemic control.

  18. The efficacy of cetirizine hydrochloride on the pruritus of cats with atopic dermatitis: a randomized, double-blind, placebo-controlled, crossover study.

    Science.gov (United States)

    Wildermuth, Kerstin; Zabel, Sonja; Rosychuk, Rod A W

    2013-12-01

    Various antihistamines have been used in the management of feline atopic dermatitis, with variable reported benefit. To date, there have been no randomized, double-blind, placebo-controlled, crossover clinical trials on the use of this drug class in cats. To evaluate the clinical efficacy of cetirizine hydrochloride for the control of pruritus and dermatitis in cats diagnosed with atopic dermatitis. In this randomized, double-blind, placebo-controlled crossover clinical trial, 21 client-owned cats diagnosed with mild to moderate nonseasonal atopic dermatitis were randomly assigned to two groups. Cats in each group received either 1 mg/kg cetirizine hydrochloride or placebo once daily per os for 28 days followed by a 14 day wash-out period. Treatments were then crossed over, and cats received placebo or cetirizine hydrochloride for another 28 days. Owners marked a pruritus severity scale before inclusion in the study and weekly throughout the entire study period. Lesions were scored by the clinician using a Canine Atopic Dermatitis Extent and Severity Index (CADESI)-03 modified for the cat before enrolment and at day 28 of each treatment. Nineteen cats completed the study. There were no statistically significant differences between treatment with cetirizine hydrochloride and placebo for modified CADESI-03 or pruritus scores. This study suggests that cetirizine hydrochloride cannot be recommended for the management of feline atopic dermatitis. © 2013 ESVD and ACVD.

  19. Patient participation in postoperative care activities in patients undergoing total knee replacement surgery: Multimedia Intervention for Managing patient Experience (MIME). Study protocol for a cluster randomised crossover trial.

    Science.gov (United States)

    McDonall, Jo; de Steiger, Richard; Reynolds, John; Redley, Bernice; Livingston, Patricia; Botti, Mari

    2016-07-18

    Patient participation is an important indicator of quality care. Currently, there is little evidence to support the belief that participation in care is possible for patients during the acute postoperative period. Previous work indicates that there is very little opportunity for patients to participate in care in the acute context. Patients require both capability, in terms of having the required knowledge and understanding of how they can be involved in their care, and the opportunity, facilitated by clinicians, to engage in their acute postoperative care. This cluster randomised crossover trial aims to test whether a multimedia intervention improves patient participation in the acute postoperative context, as determined by pain intensity and recovery outcomes. A total of 240 patients admitted for primary total knee replacement surgery will be invited to participate in a cluster randomised, crossover trial and concurrent process evaluation in at least two wards at a major non-profit private hospital in Melbourne, Australia. Patients admitted to the intervention ward will receive the multimedia intervention daily from Day 1 to Day 5 (or day of discharge, if prior). The intervention will be delivered by nurses via an iPad™, comprising information on the goals of care for each day following surgery. Patients admitted to the control ward will receive usual care as determined by care pathways currently in use across the organization. The primary endpoint is the "worst pain experienced in the past 24 h" on Day 3 following TKR surgery. Pain intensity will be measured using the numerical rating scale. Secondary outcomes are interference of pain on activities of daily living, length of stay in hospital, function and pain following TKR surgery, overall satisfaction with hospitalisation, postoperative complications and hospital readmission. The results of this study will contribute to our understanding of the effectiveness of interventions that provide knowledge and

  20. Digestive Enzyme Supplementation for Autism Spectrum Disorders: A Double-Blind Randomized Controlled Trial

    Science.gov (United States)

    Munasinghe, Sujeeva A.; Oliff, Carolyn; Finn, Judith; Wray, John A.

    2010-01-01

    To examine the effects of a digestive enzyme supplement in improving expressive language, behaviour and other symptoms in children with Autism Spectrum Disorder. Randomized, double-blind placebo-controlled trial using crossover design over 6 months for 43 children, aged 3-8 years. Outcome measurement tools included monthly Global Behaviour Rating…

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

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

    2013-01-01

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

  3. A Randomized, Crossover Trial of a Novel Sound-to-Sleep Mattress Technology in Children with Autism and Sleep Difficulties.

    Science.gov (United States)

    Frazier, Thomas W; Krishna, Jyoti; Klingemier, Eric; Beukemann, Mary; Nawabit, Rawan; Ibrahim, Sally

    2017-01-15

    This preliminary study investigated the tolerability and efficacy of a novel mattress technology-the Sound-To-Sleep (STS) system-in the treatment of sleep problems in children with autism. After screening, 45 children, ages 2.5 to 12.9 years, were randomized to order of mattress technology use (On-Off vs. Off-On). Treatment conditions (On vs. Off) lasted two weeks with immediate crossover. Tolerability, including study discontinuation and parent-report of mattress tolerance and ease of use, was tracked throughout the study. Efficacy assessments were obtained at baseline, prior to crossover, and end of study and included measures of autism traits, other psychopathology symptoms, sensory abnormalities, communication difficulties, quality of life, sleep diary parameters, and single-blinded actigraphy-derived sleep parameters. Statistical analyses evaluated differences in tolerability and efficacy when the STS system was on versus off. STS system use was well tolerated (n = 2, 4.4% dropout) and resulted in parent-reported sleep quality improvements (STS off mean = 4.3, 95% CI = 4.05-4.54 vs. on mean = 4.9, 95%CI = 4.67-5.14). The technology was described by parents as very easy to use and child tolerance was rated as good. Parent-diary outcomes indicated improvements in falling asleep and reduced daytime challenging behavior. Actigraphy-derived sleep parameters indicated improved sleep duration and sleep efficiency. Improvements in child and family quality of life were identified on parent questionnaires. A future large sample phase 2 trial of the STS system is warranted and would benefit from extended study duration, an objective primary efficacy outcome, and careful attention to methodological issues that promote compliance with the intervention and study procedures. © 2017 American Academy of Sleep Medicine

  4. Performance and economic evaluation of the molecular detection of pathogens for patients with severe infections: the EVAMICA open-label, cluster-randomised, interventional crossover trial.

    Science.gov (United States)

    Cambau, Emmanuelle; Durand-Zaleski, Isabelle; Bretagne, Stéphane; Brun-Buisson, Christian; Cordonnier, Catherine; Duval, Xavier; Herwegh, Stéphanie; Pottecher, Julien; Courcol, René; Bastuji-Garin, Sylvie

    2017-11-01

    Microbiological diagnosis (MD) of infections remains insufficient. The resulting empirical antimicrobial therapy leads to multidrug resistance and inappropriate treatments. We therefore evaluated the cost-effectiveness of direct molecular detection of pathogens in blood for patients with severe sepsis (SES), febrile neutropenia (FN) and suspected infective endocarditis (SIE). Patients were enrolled in a multicentre, open-label, cluster-randomised crossover trial conducted during two consecutive periods, randomly assigned as control period (CP; standard diagnostic workup) or intervention period (IP; additional testing with LightCycler ® SeptiFast). Multilevel models used to account for clustering were stratified by clinical setting (SES, FN, SIE). A total of 1416 patients (907 SES, 440 FN, 69 SIE) were evaluated for the primary endpoint (rate of blood MD). For SES patients, the MD rate was higher during IP than during CP [42.6% (198/465) vs. 28.1% (125/442), odds ratio (OR) 1.89, 95% confidence interval (CI) 1.43-2.50; P analysis of the incremental cost-effectiveness ratio showed weak dominance of intervention in SES patients. Addition of molecular detection to standard care improves MD and thus efficiency of healthcare resource usage in patients with SES. ClinicalTrials.gov registration number: NCT00709358.

  5. Polyethylene glycol 3350 plus electrolytes for chronic constipation in children: a double blind, placebo controlled, crossover study.

    Science.gov (United States)

    Thomson, M A; Jenkins, H R; Bisset, W M; Heuschkel, R; Kalra, D S; Green, M R; Wilson, D C; Geraint, M

    2007-11-01

    To assess the efficacy and safety of polyethylene glycol 3350 plus electrolytes (PEG+E) for the treatment of chronic constipation in children. Randomised, double blind, placebo controlled crossover trial, with two 2-week treatment periods separated by a 2-week placebo washout. Six UK paediatric departments. 51 children (29 girls, 22 boys) aged 24 months to 11 years with chronic constipation (lasting > or =3 months), defined as or =25% of bowel movements with straining; > or =25% of bowel movements with hard/lumpy stools. 47 children completed the double blind treatment. Number of complete defaecations per week (primary efficacy variable), total number of complete and incomplete defaecations per week, pain on defaecation, straining on defaecation, faecal incontinence, stool consistency, global assessment of treatment, adverse events and physical examination. The mean number of complete defaecations per week was significantly higher for children on PEG+E than on placebo (3.12 (SD 2.05) v 1.45 (SD 1.20), respectively; pPEG+E were observed for total number of defaecations per week (p = 0.003), pain on defaecation (p = 0.041), straining on defaecation (pPEG+E (41%) and placebo during treatment (45%). PEG+E is significantly more effective than placebo, and appears to be safe and well tolerated in the treatment of chronic constipation in children.

  6. Effect of cessation of GH treatment on cognition during transition phase in Prader-Willi syndrome: results of a 2-year crossover GH trial.

    Science.gov (United States)

    Kuppens, R J; Mahabier, E F; Bakker, N E; Siemensma, E P C; Donze, S H; Hokken-Koelega, A C S

    2016-11-16

    Patients with Prader-Willi syndrome (PWS) have a cognitive impairment. Growth hormone (GH) treatment during childhood improves cognitive functioning, while cognition deteriorates in GH-untreated children with PWS. Cessation of GH treatment at attainment of adult height (AH) might deteriorate their GH-induced improved cognition, while continuation might benefit them. We, therefore, investigated the effects of placebo versus GH administration on cognition in young adults with PWS who were GH-treated for many years during childhood and had attained AH. Two-year, randomized, double-blind, placebo-controlled cross-over study in 25 young adults with PWS. Cross-over intervention with placebo and GH (0.67 mg/m 2 /day), both during 1 year. Total (TIQ), verbal (VIQ) and performance IQ (PIQ) did not deteriorate during 1 year of placebo, compared to GH treatment (p > 0.322). Young adults with a lower TIQ had significantly more loss of TIQ points during placebo versus GH, in particular VIQ decreased more in those with a lower VIQ. The effect of placebo versus GH on TIQ, VIQ and PIQ was not different for gender or genotype. Compared to GH treatment, 1 year of placebo did not deteriorate cognitive functioning of GH-treated young adults with PWS who have attained AH. However, patients with a lower cognitive functioning had more loss in IQ points during placebo versus GH treatment. The reassuring finding that 1 year of placebo does not deteriorate cognitive functioning does, however, not exclude a gradual deterioration of cognitive functioning on the long term. ISRCTN24648386 , NTR1038 , Dutch Trial Register, www.trialregister.nl . Registered 16 August 2007.

  7. 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.

  8. Design and Control of Cooperativity in Spin-Crossover in Metal–Organic Complexes: A Theoretical Overview

    Directory of Open Access Journals (Sweden)

    Hrishit Banerjee

    2017-07-01

    Full Text Available Metal organic complexes consisting of transition metal centers linked by organic ligands, may show bistability which enables the system to be observed in two different electronic states depending on external condition. One of the spectacular examples of molecular bistability is the spin-crossover phenomena. Spin-Crossover (SCO describes the phenomena in which the transition metal ion in the complex under the influence of external stimuli may show a crossover between a low-spin and high-spin state. For applications in memory devices, it is desirable to make the SCO phenomena cooperative, which may happen with associated hysteresis effect. In this respect, compounds with extended solid state structures containing metal ions connected by organic spacer linkers like linear polymers, coordination network solids are preferred candidates over isolated molecules or molecular assemblies. The microscopic understanding, design and control of mechanism driving cooperativity, however, are challenging. In this review we discuss the recent theoretical progress in this direction.

  9. Feasibility of Protective Ventilation During Elective Supratentorial Neurosurgery: A Randomized, Crossover, Clinical Trial.

    Science.gov (United States)

    Ruggieri, Francesco; Beretta, Luigi; Corno, Laura; Testa, Valentina; Martino, Enrico A; Gemma, Marco

    2017-06-30

    Traditional ventilation approaches, providing high tidal volumes (Vt), produce excessive alveolar distention and lung injury. Protective ventilation, employing lower Vt and positive end-expiratory pressure (PEEP), is an attractive alternative also for neuroanesthesia, when prolonged mechanical ventilation is needed. Nevertheless, protective ventilation during intracranial surgery may exert dangerous effects on intracranial pressure (ICP). We tested the feasibility of a protective ventilation strategy in neurosurgery. Our monocentric, double-blind, 1:1 randomized, 2×2 crossover study aimed at studying the effect size and variability of ICP in patients undergoing elective supratentorial brain tumor removal and alternatively ventilated with Vt 9 mL/kg-PEEP 0 mm Hg and Vt 7 mL/kg-PEEP 5 mm Hg. Respiratory rate was adjusted to maintain comparable end-tidal carbon dioxide between ventilation modes. ICP was measured through a subdural catheter inserted before dural opening. Forty patients were enrolled; 8 (15%) were excluded after enrollment. ICP did not differ between traditional and protective ventilation (11.28±5.37, 11 [7 to 14.5] vs. 11.90±5.86, 11 [8 to 15] mm Hg; P=0.541). End-tidal carbon dioxide (28.91±2.28, 29 [28 to 30] vs. 28.00±2.17, 28 [27 to 29] mm Hg; Pprotective ventilation. Blood pressure, heart rate, and body temperature did not differ between ventilation modes. Dural tension was "acceptable for surgery" in all cases. ICP differences between ventilation modes were not affected by ICP values under traditional ventilation (coefficient=0.067; 95% confidence interval, -0.278 to 0.144; P=0.523). Protective ventilation is a feasible alternative to traditional ventilation during elective neurosurgery.

  10. Impaired alcohol metabolism after gastric bypass surgery: a case-crossover trial.

    Science.gov (United States)

    Woodard, Gavitt A; Downey, John; Hernandez-Boussard, Tina; Morton, John M

    2011-02-01

    Severe obesity remains the leading public health crisis of the industrialized world, with bariatric surgery the only effective and enduring treatment. Poor psychological adjustment has been occasionally reported postoperatively. In addition, evidence suggests that patients can metabolize alcohol differently after gastric bypass. Preoperatively and at 3 and 6 months postoperatively, 19 Roux-en-Y gastric bypass (RYGB) patients' breath alcohol content (BAC) was measured every 5 minutes after drinking 5 oz red wine to determine peak BAC and time until sober in a case-crossover design preoperatively and at 6 months postoperatively. Patients reported symptoms experienced when intoxicated and answered a questionnaire of drinking habits. The peak BAC in patients after RYGB was considerably higher at 3 months (0.059%) and 6 months (0.088%) postoperatively than matched preoperative levels (0.024%). Patients also took considerably more time to return to sober at 3 months (61 minutes) and 6 months (88 minutes) than preoperatively (49 minutes). Postoperative intoxication was associated with lower levels of diaphoresis, flushing, and hyperactivity and higher levels of dizziness, warmth, and double vision. Postoperative patients reported drinking considerably less alcohol, fewer preferred beer, and more preferred wine than before surgery. This is the first study to match preoperative and postoperative alcohol metabolism in gastric bypass patients. Post-RYGB patients have much higher peak BAC after ingesting alcohol and require more time to become sober. Patients who drink alcohol after gastric bypass surgery should exercise caution. Copyright © 2011 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  11. Cardiac effects of granisetron in a prospective crossover randomized dose comparison trial.

    Science.gov (United States)

    Cakir, F B; Yapar, O; Canpolat, C; Akalin, F; Berrak, S G

    2012-10-01

    Cardiac side effects of granisetron have been studied mostly in adult patients that are using cardiotoxic chemotherapeutics. There is limited evidence in pediatric age group and no information in pediatric oncology patients with non-cardiotoxic chemotherapeutics. In this prospective, crossover randomized study, the cardiac side effects of granisetron are compared in pediatric oncology patients who had carboplatin based chemotherapy. They were randomized to receive either 10 or 40 μg kg(-1) dose(-1) of granisetron before each cycle of chemotherapy. We drew blood for creatine phosphokinase (CPK), CPK-muscle band (MB) and Troponin-T before and 24 h after administering granisetron. Electrocardiography (ECG) tracings were taken at 0, 1, 2, 3, 6 and 24 h of granisetron. Twenty-four hours Holter ECG monitorisation was performed after each granisetron infusion. A total of 16 patients (median 8.7 years of age) were treated with weekly consecutive courses of carboplatin. There was bradycardia (p = 0.000) in patients that had granisetron at 40 μg/kg and PR interval was shortened in patients that had granisetron at 10 μg/kg dose (p = 0.021). At both doses of granisetron, QTc interval and dispersion were found to be similar. CPK, CK-MB and Troponin-T values were found to be normal before and 24 h after granisetron infusion. As the first study that has studied cardiac side effects of granisetron in patients that are not using cardiotoxic chemotherapeutics, we conclude that granisetron at 40 μg kg(-1) dose(-1) causes bradycardia only. We have also demonstrated that granisetron does not cause any clinically cardiac side effects either at 10 or 40 μg kg(-1) dose(-1). However, our results should be supported by prospective randomized studies with larger samples of patient groups.

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

    Science.gov (United States)

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

    2004-09-01

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

  13. a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    MS Yıldırım

    2016-02-01

    Full Text Available The aim of this study was to compare the effects of static stretching, proprioceptive neuromuscular facilitation (PNF stretching and Mulligan technique on hip flexion range of motion (ROM in subjects with bilateral hamstring tightness. A total of 40 students (mean age: 21.5±1.3 years, mean body height: 172.8±8.2 cm, mean body mass index: 21.9±3.0 kg • m-2 with bilateral hamstring tightness were enrolled in this randomized trial, of whom 26 completed the study. Subjects were divided into 4 groups performing (I typical static stretching, (II PNF stretching, (III Mulligan traction straight leg raise (TSLR technique, (IV no intervention. Hip flexion ROM was measured using a digital goniometer with the passive straight leg raise test before and after 4 weeks by two physiotherapists blinded to the groups. 52 extremities of 26 subjects were analyzed. Hip flexion ROM increased in all three intervention groups (p<0.05 but not in the no-intervention group after 4 weeks. A statistically significant change in initial–final assessment differences of hip flexion ROM was found between groups (p<0.001 in favour of PNF stretching and Mulligan TSLR technique in comparison to typical static stretching (p=0.016 and p=0.02, respectively. No significant difference was found between Mulligan TSLR technique and PNF stretching (p=0.920. The initial–final assessment difference of hip flexion ROM was similar in typical static stretching and no intervention (p=0.491. A 4-week stretching intervention is beneficial for increasing hip flexion ROM in bilateral hamstring tightness. However, PNF stretching and Mulligan TSLR technique are superior to typical static stretching. These two interventions can be alternatively used for stretching in hamstring tightness.

  14. 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 (C max ; 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.

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

    Science.gov (United States)

    Fiorentino, Lavinia; McQuaid, John R; Liu, Lianqi; Natarajan, Loki; He, Feng; Cornejo, Monique; Lawton, Susan; Parker, Barbara A; Sadler, Georgia R; Ancoli-Israel, Sonia

    2010-01-01

    Purpose 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. PMID:23616695

  16. 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

  17. Assessing methods for dealing with treatment crossover in clinical trials: A follow-up simulation study

    OpenAIRE

    Latimer, N.R.; Abrams, K.R.; Lambert, P.C.; Crowther, M.J.; Morden, J.P.

    2014-01-01

    Background: Treatment switching commonly occurs in clinical trials of novel interventions, particularly in the advanced or metastatic cancer setting, which causes important problems for health technology assessment. Previous research has demonstrated which adjustment methods are suitable in specific scenarios, but scenarios considered have been limited. \\ud Objectives: We aimed to assess statistical approaches for adjusting survival estimates in the presence of treatment switching in order to...

  18. 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

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

    Science.gov (United States)

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

    2018-05-01

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

  20. Clinical effects of specialist and on-call respiratory physiotherapy treatments in mechanically ventilated children: A randomised crossover trial.

    Science.gov (United States)

    Shannon, Harriet; Stocks, Janet; Gregson, Rachael K; Dunne, Catherine; Peters, Mark J; Main, Eleanor

    2015-12-01

    The study investigated treatment outcomes when respiratory physiotherapy was delivered by non-respiratory on-call physiotherapists, compared with specialist respiratory physiotherapists. Prospective, randomised crossover trial. Paediatric, tertiary care hospital in the United Kingdom. Mechanically ventilated children requiring two physiotherapy interventions during a single day were eligible. Twenty two physiotherapists (10 non-respiratory) and 93 patients were recruited. Patients received one treatment from a non-respiratory physiotherapist and another from a respiratory physiotherapist, in a randomised order. Treatments were individualised to the patients' needs, often including re-positioning followed by manual lung inflations, chest wall vibrations and endotracheal suction. The primary outcome was respiratory compliance. Secondary outcomes included adverse physiological events and clinically important respiratory changes (according to an a priori definition). Treatments delivered to 63 patients were analysed. There were significant improvements to respiratory compliance (mean increase [95% confidence intervals], 0.07 and 0.08ml·cmH2O(-1)·kg(-1) [0.01 to 0.14 and 0.04 to 0.13], pphysiotherapy services, both during and outside of normal working hours. Clinicaltrials.gov, NCT01999426. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  1. Can students learn clinical method in general practice? A randomised crossover trial based on objective structured clinical examinations.

    Science.gov (United States)

    Murray, E.; Jolly, B.; Modell, M.

    1997-01-01

    OBJECTIVE: To determine whether students acquired clinical skills as well in general practice as in hospital and whether there was any difference in the acquisition of specific skills in the two environments. DESIGN: Randomised crossover trial. SUBJECTS AND SETTING: Annual intake of first year clinical students at one medical school. INTERVENTION: A 10 week block of general internal medicine, one half taught in general practice, the other in hospital. Students started at random in one location and crossed over after five weeks. OUTCOME MEASURES: Students' performance in two equivalent nine station objective structured clinical examinations administered at the mid and end points of the block: a direct comparison of the two groups' performance at five weeks; analysis of covariance, using their first examination scores as a covariate, to determine students' relative improvement over the second five weeks of their attachment. RESULTS: 225 students rotated through the block; all took at least one examination and 208 (92%) took both. For the first half of the year there was no significant difference in the students' acquisition of clinical skills in the two environments; later, however, students taught in general practice improved slightly more than those taught in hospital (P = 0.007). CONCLUSIONS: Students can learn clinical skills as well in general practice as in hospital; more work is needed to clarify where specific skills, knowledge, and attitudes are best learnt to allow rational planning of the undergraduate curriculum. PMID:9361543

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

    Directory of Open Access Journals (Sweden)

    Mandana Mirmohammadali

    2014-02-01

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

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

    Science.gov (United States)

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

    2018-04-01

    Both physical activity and relaxation have stress-relieving potential. This study investigates their combined impact on the relaxation response while considering participants' initial stress level. In a randomized cross-over trial, 81 healthy adults completed 4 types of short-term interventions for stress reduction, each lasting for 1 hr: (1) physical activity (walking) combined with resting, (2) walking combined with balneotherapy, (3) combined resting and balneotherapy, and (4) resting only. Saliva cortisol, blood pressure, state of mood, and relaxation were measured preintervention and postintervention. Stress levels were determined by validated questionnaires. All interventions were associated with relaxation responses in the variables saliva cortisol, blood pressure, state of mood, and subjective relaxation. No significant differences were found regarding the reduction of salivary cortisol (F = 1.30; p = .281). The systolic blood pressure was reduced best when walking was combined with balneotherapy or resting (F = 7.34; p stress levels (n = 25) felt more alert after interventions including balneotherapy, whereas they reported an increase of tiredness when walking was combined with resting (F = 3.20; p = .044). Results suggest that combining physical activity and relaxation (resting or balneotherapy) is an advantageous short-term strategy for stress reduction as systolic blood pressure is reduced best while similar levels of relaxation can be obtained. Copyright © 2017 John Wiley & Sons, Ltd.

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

    Directory of Open Access Journals (Sweden)

    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

  5. Effect of the rate of chest compression familiarised in previous training on the depth of chest compression during metronome-guided cardiopulmonary resuscitation: a randomised crossover trial

    OpenAIRE

    Bae, Jinkun; Chung, Tae Nyoung; Je, Sang Mo

    2016-01-01

    Objectives To assess how the quality of metronome-guided cardiopulmonary resuscitation (CPR) was affected by the chest compression rate familiarised by training before the performance and to determine a possible mechanism for any effect shown. Design Prospective crossover trial of a simulated, one-person, chest-compression-only CPR. Setting Participants were recruited from a medical school and two paramedic schools of South Korea. Participants 42 senior students of a medical school and two pa...

  6. Improvdent: Improving dentures for patient benefit. A crossover randomised clinical trial comparing impression materials for complete dentures

    Directory of Open Access Journals (Sweden)

    Gray Janine C

    2012-08-01

    Full Text Available Abstract Background According to the UK Adult Dental Health Survey (2009 15% of adults aged 65–74, 30% aged 75–84 and 47% aged >85 years are edentulous and require complete dentures. Patients’ quality of life and nutrition status are affected by poor dentures. The quality of the dental impression is the most important issue for improving the fit and comfort of new dentures. There is paucity of RCT evidence for which impression material is best for complete dentures construction. This study aims to compare two impression materials for effectiveness and cost effectiveness. Methods/Design IMPROVDENT is a double-blind crossover trial comparing the use of alginate and silicone, two commonly used denture impression materials, in terms of patient preference and cost-effectiveness. Eighty five edentulous patients will be recruited and provided with two sets of dentures, similar in all aspects except for the impression material used (alginate or silicone. Patients will try both sets of dentures for a two-week period, unadjusted, to become accustomed to the feel of the new dentures (habituation period. Patients will then wear each set of dentures for a period of 8 weeks (in random order during which time the dentures will be adjusted for optimum comfort. Finally, patients will be given both sets of dentures for a further two weeks to wear whichever denture they prefer (confirmation period. Patients will be asked about quality of life and to rate dentures on function and comfort at the end of each trial period and asked which set they prefer at the end of the habituation period (unadjusted denture preference and confirmation period (adjusted denture preference. A health economic evaluation will estimate incremental cost-effectiveness ratios of producing dentures from the two materials. A qualitative study will investigate the impact of dentures on behaviour and quality of life. Funding: IMPROVDENT is funded by NIHR RfPB (PB-PG-0408-16300. Discussion

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

    Science.gov (United States)

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

    2013-11-01

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

  8. A novel magnetic stimulator increases experimental pain tolerance in healthy volunteers - a double-blind sham-controlled crossover study.

    Directory of Open Access Journals (Sweden)

    Rudie Kortekaas

    Full Text Available UNLABELLED: The 'complex neural pulse'(TM (CNP is a neuromodulation protocol employing weak pulsed electromagnetic fields (PEMF. A pioneering paper reported an analgesic effect in healthy humans after 30 minutes of CNP-stimulation using three nested whole head coils. We aimed to devise and validate a stimulator with a novel design entailing a multitude of small coils at known anatomical positions on a head cap, to improve applicability. The main hypothesis was that CNP delivery with this novel device would also increase heat pain thresholds. Twenty healthy volunteers were enrolled in this double-blind, sham-controlled, crossover study. Thirty minutes of PEMF (CNP or sham was applied to the head. After one week the other treatment was given. Before and after each treatment, primary and secondary outcomes were measured. Primary outcome was heat pain threshold (HPT measured with thermal quantitative sensory testing. Other outcomes were warmth detection threshold, and aspects of cognition, emotion and motor performance. As hypothesized heat pain threshold was significantly increased after the PEMF stimulation. All other outcomes were unaltered by the PEMF but there was a trend level reduction of cognitive performance after PEMF stimulation as measured by the digit-symbol substitution task. Results from this pilot study suggest that our device is able to stimulate the brain and to modulate its function. This is in agreement with previous studies that used similar magnetic field strengths to stimulate the brain. Specifically, pain control may be achieved with PEMF and for this analgesic effect, coil design does not appear to play a dominant role. In addition, the flexible configuration with small coils on a head cap improves clinical applicability. TRIAL REGISTRATION: Dutch Cochrane Centre NTR1093.

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

    Science.gov (United States)

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

    2013-10-01

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

  10. Hyperkinesis and diet: a double-blind crossover trial with a tartrazine challenge.

    Science.gov (United States)

    Levy, F; Dumbrell, S; Hobbes, G; Ryan, M; Wilton, N; Woodhill, J M

    1978-01-28

    A pilot study was conducted on 22 children (19 boys and three girls) aged between four and eight years, who were selected as hyperactive on the basis of developmental history and clinical judgement. Conners' parent-teacher ratings, objective tests of attention, standard perceptualmotor tests and subtests from the Wechsler Intelligence Scale for Children (WISC), were used as response variables. The children were tested before and after four weeks on the elimination diet, after a tartrazine and placebo challenge, and, finally, after a four-week washout period on the diet. Results showed a statistically significant improvement in the mothers' ratings of the children's behaviour after the first four weeks of the diet. The improvement was maintained in a combined analysis of the initial four-week diet period and four-week washout period. This result was not substantiated by the statistical analysis of the results from objective tests. The rating scales and objective tests for the full sample did not show a statistically significant deterioration in the children's behaviour when they were challenged under double-blind test conditions with the Yellow Dye No. 5, tartrazine, and the tests were conducted the day after a two-week challenge period. A comparison of mother ratings of behaviour during challenge and placebo double-blind trial and in the 24 hours preceding tests, in a subgroup of the children who, while on the diet, showed a 25% reduction of symptoms on the Conner's rating scale, indicated a significant challenge effect (P less than 0.025), with mothers reporting more symptoms during the challenge period. Dietary infringements with suspected trigger substances occurred throughout the trial.

  11. Ring-Expansion/Contraction Radical Crossover Reactions of Cyclic Alkoxyamines: A Mechanism for Ring Expansion-Controlled Radical Polymerization

    Directory of Open Access Journals (Sweden)

    Atsushi Narumi

    2018-06-01

    Full Text Available Macrocyclic polymers present an important class of macromolecules, displaying the reduced radius of gyration or impossibility to entangle. A rare approach for their synthesis is the ring expansion-controlled radical “vinyl” polymerization, starting from a cyclic alkoxyamine. We here describe ring-expansion radical crossover reactions of cyclic alkoxyamines which run in parallel to chain-propagation reactions in the polymerization system. The radical crossover reactions extensively occurred at 105–125 °C, eventually producing high molecular weight polymers with multiple inherent dynamic covalent bonds (NOC bonds. A subsequent ring-contraction radical crossover reaction and the second ring-expansion radical crossover reaction are also described. The major products for the respective three stages were shown to possess cyclic morphologies by the molecular weight profiles and the residual ratios for the NOC bonds (φ in %. In particular, the high φ values ranging from ca. 80% to 98% were achieved for this cyclic alkoxyamine system. This result verifies the high availability of this system as a tool demonstrating the ring-expansion “vinyl” polymerization that allows them to produce macrocyclic polymers via a one-step vinyl polymerization.

  12. Randomized double-blind placebo-controlled crossover study of caffeine in patients with intermittent claudication.

    Science.gov (United States)

    Momsen, A H; Jensen, M B; Norager, C B; Madsen, M R; Vestersgaard-Andersen, T; Lindholt, J S

    2010-10-01

    Intermittent claudication is a disabling symptom of peripheral arterial disease for which few medical treatments are available. This study investigated the effect of caffeine on physical capacity in patients with intermittent claudication. This randomized double-blind placebo-controlled crossover study included 88 patients recruited by surgeons from outpatient clinics. The participants abstained from caffeine for 48 h before each test and then received either a placebo or oral caffeine (6 mg/kg). After 75 min, pain-free and maximal walking distance on a treadmill, perceived pain, reaction times, postural stability, maximal isometric knee extension strength, submaximal knee extension endurance and cognitive function were measured. The analysis was by intention to treat. Caffeine increased the pain-free walking distance by 20.0 (95 per cent confidence interval 3.7 to 38.8) per cent (P = 0.014), maximal walking distance by 26.6 (12.1 to 43.0) per cent (P postural stability was reduced significantly, by 22.1 (11.7 to 33.4) per cent with eyes open (P < 0.001) and by 21.8 (7.6 to 37.8) per cent with eyes closed (P = 0.002). Neither reaction time nor cognition was affected. In patients with moderate intermittent claudication, caffeine increased walking distance, maximal strength and endurance, but affected balance adversely.

  13. Similar effects of leucine rich and regular dairy products on muscle mass and functions of older polymyalgia rheumatica patients: a randomized crossover trial.

    Science.gov (United States)

    Björkman, M P; Pilvi, T K; Kekkonen, R A; Korpela, R; Tilvis, R S

    2011-06-01

    Leucine-rich milk and whey proteins have been suggested for prevention of age related loss of muscle mass and strength i.e. sarcopenia. The effects of milk protein supplementation and low intensity home based physical exercise on body composition and muscle functions were investigated. A randomized double blind crossover trial. Community dwelling members of Helsinki rheumatoid association. Older people (N=47, mean age 69.5 years) suffering from polymyalgia rheumatica. Patients performed as many stand ups as possible twice a day after which they ingested a regular (Control) or a whey protein enriched dairy product with high leucine content (Test). The 8-week intervention periods were separated by a 4-week wash-out. Body composition was measured by dual x-ray absorptiometry and muscle functions by hand grip strength, force platform countermovement jump performance, chair stand test, and walking speed. The 16-week home-based post-exercise supplementation resulted in a 1.8% increase (p = 0.052) in lower limb muscle mass. Walking speed (+5.3%, p = 0.007) and chair stand test performance (-12.2 %, p products prevent or treat age-associated sarcopenia and whether they are superior to the present commercial milk products.

  14. The Effect of Body Position on Pain Due to Nasal Continuous Positive Airway Pressure (CPAP in Premature Neonates: A Cross-Over Clinical Trial Study

    Directory of Open Access Journals (Sweden)

    Mahnaz Jabraeili

    2018-01-01

    Full Text Available Background The most common cause of admission to neonatal intensive care units (NICU is respiratory distress syndrome. One of the respiratory assistance methods is using nasal continuous positive airway pressure (CPAP. Regarding the importance of pain control which is one of the major priorities in neonatal nursing care, this study aimed to evaluate the effect of body position on pain due to nasal CPAP in premature neonates. Materials and Methods In this cross-over clinical trial, 50 premature neonates who were receiving nasal CPAP admitted to the NICU of Imam Reza Hospital, Kermanshah, Iran, were included. The neonates were randomly placed at three body positions (fetal, supine, and prone positions. Pain was measured by Astrid Lindgren Children’s Hospital Pain Scale Neonates (ALPS-Neo pain assessment scale. The collected data were analyzed using the SPSS software (Version 22.0. Results Significant difference existed regarding pain of nasal CPAP among body positions (p< 0.001. Mean (SD pain was 5.15 (0.822 in fetal position, 6.260 (0.747 in prone position and 7.326 (0.792 in supine position. Conclusion Body positioning in premature neonates under nasal CPAP in NICU can be effective as a non-pharmacologic method in alleviating pain due to nasal CPAP. Among the studied positions, the lowest pain score was seen in fetal position.

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

    DEFF Research Database (Denmark)

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

    2013-01-01

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

  16. Robustness of crossover trials against subject drop-out - Examples of perpetually connected designs.

    Science.gov (United States)

    Godolphin, P J; Godolphin, E J

    2017-01-01

    When performing a repeated measures experiment, such as a clinical trial, there is a risk of subject drop-out during the experiment. If one or more subjects leave the study prematurely, a situation could arise where the eventual design is disconnected, implying that very few treatment contrasts for both direct effects and carryover effects are estimable. This paper aims to identify experimental conditions where this problem with the eventual design can be avoided. It is shown that in the class of uniformly balanced repeated measurement designs consisting of two or more Latin squares, there are planned designs with the following useful property. Provided that all subjects have completed the first two periods of study, such a design will not be replaced by a disconnected eventual design due to drop-out, irrespective of the type of drop-out behaviour that may occur. Designs with this property are referred to as perpetually connected. These experimental conditions are identified and examined in the paper and an example of at least one perpetually connected uniformly balanced repeated measurement design is given in each case. The results improve upon previous contributions in the literature that have been confined largely to cases in which drop-out occurs only in the final periods of study.

  17. 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

  18. The acceptability of the female and male condom: a randomized crossover trial.

    Science.gov (United States)

    Kulczycki, Andrzej; Kim, Dhong-Jin; Duerr, Ann; Jamieson, Denise J; Macaluso, Maurizio

    2004-01-01

    Although studies have assessed the acceptability of male and female condoms, comparative trial data are lacking. A sample of 108 women in stable relationships recruited from an urban, reproductive health clinic were randomly assigned to use 10 male or female condoms, followed by use of 10 of the other type. A nurse provided instruction in correct method use. Demographic information was collected in a baseline questionnaire; acceptability data were collected in follow-up and exit questionnaires and coital logs. Nonparametric and chi-square statistics were used to analyze measures of the methods' relative acceptability. Bowker's test of symmetry was adapted to test the null hypothesis of no difference in acceptability between condom types. Participants used 678 female and 700 male condoms. Although neither method scored high on user satisfaction measures, the 63 women completing the study protocol preferred the male condom to the female condom for ease of application or insertion, ease of removal, general fit, feel of the condom during intercourse and ease of penetration. Participants reported that their partner also favored the male condom, although women generally appeared to like this method more than their partner did. In a direct comparison between the methods at the end of the study, women generally judged male condoms superior on specified preference criteria. Across a range of criteria, the female condom was less acceptable than the male condom to most women and their partners. Although both types had low acceptability, they are needed and valid methods of pregnancy and disease prevention. That neither rated high on user satisfaction measures underscores the need for more barrier methods that women and men can use.

  19. Electric crossover

    International Nuclear Information System (INIS)

    Schuster, R.M.; Luria, N.G.

    1977-01-01

    This invention concerns an electric crossover that makes a steam and pressure-tight seal for a conductor crossing two separate walls of a nuclear reactor vessel that seismic tremors or thermal expansion of the walls and conductor subject to relative displacements. The conductors, that have to cross the vessels, are fixed to the walls of the vessel in crossover systems fitted in crossover channels made in the walls of the vessel on their initial manufacture. The separate walls of the vessel move independently when they undergo an earth tremor or a temperature change between the walls or between the conductor. This shift can damage the conductor or the crossover system and this could give rise to cause steam or other materials to leak in the reactor should leaks occur in the primary system. Furthermore, in the case of medium or high power conductors, which are relatively rigid, the non-alignment of the crossover channels can bring about awkward stresses in the conductors or their protective sheathing. The aims of this invention are fulfilled by designing an electric crossover to pass at least one conductor through the two separate walls of a vessels, that includes an initial sub-assembly crossover, secured in a leak-tight manner to the first wall and a second sub-sessembly crossover in sliding or rolling contact with the second wall, whilst forming a leak-tight seal with it [fr

  20. Paracetamol 325 mg/tramadol 37.5 mg effect on pain during needle electromyography: a double-blind crossover clinical trial.

    Science.gov (United States)

    Kalantar, Seyed Sadeq; Abbasi, Mehrshad; Faghihi-Kashani, Sara; Majedi, Hossein; Ahmadi, Mona; Agah, Elmira; Tafakhori, Abbas

    2016-12-01

    Needle insertion during electromyography (EMG) may cause varying levels of pain that could lead to inaccurate assessment and premature termination of the procedure. The aim of this study is to compare paracetamol 325 mg/tramadol 37.5 mg with placebo in relieving pain before EMG. This is a randomized, crossover, placebo-controlled, double-blind clinical trial; forty-four healthy individuals, including 27 males with a mean age of 35.3 years (range 18-59 years), entered this study. The needles were inserted unilaterally 2 h after administration of two analgesic tablets of paracetamol 325 mg/tramadol 37.5 mg or two placebo tablets. The pain was scored through a 100-mm visual analog scale (VAS) immediately and 2 h after the procedure. The side effects were also recorded. Within a week, the procedure was repeated on the other upper limb, changing the treatment and placebo. The immediate and 2-h VAS scores were notably lower after administration of treatment compared to placebo (immediate pain: 17.5 ± 12.8 vs. 32.1 ± 16.0, P pain: 1.6 ± 5.6 vs. 5.8 ± 7.9, P = 0. 002). There was a higher prevalence of side effects when treatment was used (48 vs. 9 %, P pain. Further application of this medication in patients with neuromuscular disorders would warrant additional clinical trials, particularly considering the adverse events.

  1. Anti-mite measurements in mite-sensitive adult asthma. A controlled trial.

    Science.gov (United States)

    Burr, M L; St Leger, A S; Neale, E

    1976-02-14

    A cross-over controlled trial has been conducted among 32 adult patients with mite-sensitive asthma. The bedclothes and pillows of each subject were laundered and vacuum-cleaned and a plastic cover applied to the mattress for six weeks in an attempt to reduce exposure to mites. No improvement in daily peak-flow reading or drug usage was found in comparison with a control period.

  2. Multicentre randomised double bind crossover trial on contamination of conventional ties and bow ties in routine obstetric and gynaecological practice.

    Science.gov (United States)

    Biljan, M M; Hart, C A; Sunderland, D; Manasse, P R; Kingsland, C R

    1993-01-01

    OBJECTIVE--To assess level of contamination of neckwear worn by gynaecologists and obstetricians during routine working week. DESIGN--Multicentre randomised double blind crossover trial. Participants wore the same conventional ties for three days in one week and bow ties for the same period in second week. SETTING--Two teaching and three district general hospitals in the midlands, Wales, and north England. SUBJECTS--15 registrars and senior registrars. INTERVENTIONS--A swab soaked in sterile saline was taken from specific area on ties at end of first and third working days and sent in transport medium for culture on chocolatised blood and MacConkey agar for 48 hours. MAIN OUTCOME MEASURES--Level of bacteriological growth assessed semiquantitatively (0 for no contamination; for heavy contamination) after swabs had been cultured. At end of study the participants completed a questionnaire to assess their attitude toward wearing different types of necktie. RESULTS--12 doctors (80%) completed the study. Although bow ties were significantly less contaminated at end of first working day (z = -2.354, p = 0.019), this difference was not maintained; there was no difference in level of contamination on third day. Level of contamination did not increase between first and third day of wearing the same garment. One of the 10 doctors who returned the questionnaire found the bow tie very uncomfortable. All participants would consider wearing a bow tie if it proved to be less contaminated than a conventional tie. CONCLUSIONS--Although a significant difference in contamination was established between conventional and bow ties on first day of study, this difference was not confirmed on third day and there is unlikely to be any real association between tie type and bacterial contamination. Because of its negative image and difficulty to tie, the bow tie will probably remain a minority fashion. Images p1583-a PMID:8292945

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

    Directory of Open Access Journals (Sweden)

    Leila Valizadeh

    2017-06-01

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

  4. 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

  5. Cardiopulmonary benefits of reducing indoor particles of outdoor origin: a randomized, double-blind crossover trial of air purifiers.

    Science.gov (United States)

    Chen, Renjie; Zhao, Ang; Chen, Honglei; Zhao, Zhuohui; Cai, Jing; Wang, Cuicui; Yang, Changyuan; Li, Huichu; Xu, Xiaohui; Ha, Sandie; Li, Tiantian; Kan, Haidong

    2015-06-02

    Indoor exposure to fine particulate matter (PM2.5) from outdoor sources is a major health concern, especially in highly polluted developing countries such as China. Few studies have evaluated the effectiveness of indoor air purification on the improvement of cardiopulmonary health in these areas. This study sought to evaluate whether a short-term indoor air purifier intervention improves cardiopulmonary health. We conducted a randomized, double-blind crossover trial among 35 healthy college students in Shanghai, China, in 2014. These students lived in dormitories that were randomized into 2 groups and alternated the use of true or sham air purifiers for 48 h with a 2-week washout interval. We measured 14 circulating biomarkers of inflammation, coagulation, and vasoconstriction; lung function; blood pressure (BP); and fractional exhaled nitric. We applied linear mixed-effect models to evaluate the effect of the intervention on health outcome variables. On average, air purification resulted in a 57% reduction in PM2.5 concentration, from 96.2 to 41.3 μg/m3, within hours of operation. Air purification was significantly associated with decreases in geometric means of several circulating inflammatory and thrombogenic biomarkers, including 17.5% in monocyte chemoattractant protein-1, 68.1% in interleukin-1β, 32.8% in myeloperoxidase, and 64.9% in soluble CD40 ligand. Furthermore, systolic BP, diastolic BP, and fractional exhaled nitrous oxide were significantly decreased by 2.7%, 4.8%, and 17.0% in geometric mean, respectively. The impacts on lung function and vasoconstriction biomarkers were beneficial but not statistically significant. This intervention study demonstrated clear cardiopulmonary benefits of indoor air purification among young, healthy adults in a Chinese city with severe ambient particulate air pollution. (Intervention Study on the Health Impact of Air Filters in Chinese Adults; NCT02239744). Copyright © 2015 American College of Cardiology Foundation

  6. Patient preference and satisfaction with implant-supported mandibular overdentures retained with ball or locator attachments: a crossover clinical trial.

    Science.gov (United States)

    Krennmair, Gerald; Seemann, Rudolf; Fazekas, Andres; Ewers, Rolf; Piehslinger, Eva

    2012-01-01

    To determine patient satisfaction and preference for implant-supported mandibular overdentures (IOD) retained with ball or Locator attachments. In addition, peri-implant conditions and prosthodontic maintenance efforts for the final attachments were evaluated after 1 year of function. In this crossover clinical trial, 20 edentulous patients were recruited to receive two mandibular implants in the canine region and were provided with implant-retained mandibular overdentures and new complete maxillary dentures. Implant-retained mandibular overdentures were stabilized with either ball attachments or Locator attachments, in random order. After 3 months of function, the attachments in the existing denture were changed. Questionnaires on satisfaction/complaints with the prostheses were administered at baseline (with the old dentures) and after 3 months of function with each attachment, thus providing for an intraindividual comparison. The decision for the final attachment chosen was based on the patient's preference. For the definitive attachment, peri-implant conditions (peri-implant marginal bone resorption, pocket depth, and Plaque Index, Gingival Index, and Bleeding Index) as well as prosthodontic maintenance efforts and satisfaction score were evaluated after an insertion period of 1 year. Nineteen (95%) patients completed the study (1 dropout). Patient satisfaction improved significantly (P<.05) from baseline (old dentures) to the new prostheses retained with each of the two attachment types for all domains of satisfaction. However, there were no differences between ball or Locator attachment for any items of satisfaction evaluated and neither attachment had a significant patient preference. No differences for peri-implant parameters or for patient satisfaction were noted between the definitive attachments (ball, n=10; Locator, n=9) after 1 year. Although the overall incidence rate of prosthodontic maintenance did not significantly differ between both retention

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

    Science.gov (United States)

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

    2014-09-01

    On-call duty (OCD) is frequently associated with health and safety risks for both physicians and patients. The lack of studies conducted in clinical care environments and the ongoing public dialogue concerning OCD led to a detailed investigation of a working schedule including sleep fragmentation and extended work hours. Within-person randomized cross-over trial. Comparison of a 24h on-call shift (OCD) compared to a routine working-day (non on call, NOC) in hospital. 30 residents and senior physicians of the Department of Internal Medicine, Neurology and Otorhinolaryngology at the University Hospital Innsbruck. Sleep variables, cognitive performance (Concentration-Endurance d2 test), emotional status (Eigenschaftswoerterliste 60S), serum-cortisol, urinary cortisol and noradrenaline, heart-rate variability, and saccadic eye movements were determined before and after OCD and NOC respectively. Concentration-endurance performance was significantly reduced after OCD as compared to NOC by 16.4% (preduced after OCD (p<0.05) compared to NOC. 24 h OCD alters both, the sympathetic-adrenomedullary system as well as the hypothalamic pituitary-adrenocortical axis. Moreover, physicians' emotional state, cognitive and oculomotor performance seems to be influenced independently from sleep interruptions. The discrepancy between subjective feeling and objective cognitive impairments pose a risk for performing complex manual and cognitive tasks. Hence, our findings argue against an oversimplified interpretation of alterations in the physicians' psychoneuroendocrine structure in terms of impaired mood and neurocognitive deterioration combined with up-/dysregulated stress axes associated with OCD as a consequence of sleep deprivation. Copyright © 2014 Elsevier Ltd. All rights reserved.

  8. Effects of Intermittent Versus Continuous Walking on Distance Walked and Fatigue in Persons With Multiple Sclerosis: A Randomized Crossover Trial.

    Science.gov (United States)

    Karpatkin, Herb; Cohen, Evan T; Rzetelny, Adam; Parrott, J Scott; Breismeister, Breanne; Hartman, Ryan; Luu, Ronald; Napolione, Danielle

    2015-07-01

    Fatigue is a common, disabling symptom experienced by persons with multiple sclerosis (MS). Evidence shows that intermittent exercise is associated in improved performance and negligible fatigue. The purpose of this study was to examine whether subjects with MS walk greater distances with less fatigue under intermittent (INT) or continuous (CONT) walking condition. Twenty-seven subjects with MS (median Extended Disability Severity Scale 3.5, interquartile range 1.6) walked in the CONT (ie, 6 uninterrupted minutes) and INT (ie, three 2-minute walking bouts) conditions in a randomized crossover. Distance was measured for the entire 6-minute walking period and each 2-minute increment. Fatigue was measured as the difference in a visual analog scale of fatigue (ΔVAS-F) immediately preceding and following each trial. Participants walked greater distances in the INT condition compared to the CONT condition (P = 0.005). There was a significant interaction of walking condition and time (P walked in the INT condition changed across time. ΔVAS-F was significantly lower in the INT condition than in the CONT condition (P = 0.036). Subjects with MS walked farther, and with less fatigue, when walking intermittently rather than continuously. Persons with MS may be able to tolerate a greater dose of walking training if the walking bouts are intermittent. Further study to determine the benefits of a walking exercise program using intermittent walking is recommended.Video Abstract available for additional insights from the authors (Supplemental Digital Content 1, http://links.lww.com/JNPT/A103).

  9. 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

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

    Science.gov (United States)

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

    2013-01-01

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

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

    Science.gov (United States)

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

    2012-04-01

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

  12. A khorasan wheat-based replacement diet improves risk profile of patients with type 2 diabetes mellitus (T2DM): a randomized crossover trial.

    Science.gov (United States)

    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.

  13. A single session of hatha yoga improves stress reactivity and recovery after an acute psychological stress task-A counterbalanced, randomized-crossover trial in healthy individuals.

    Science.gov (United States)

    Benvenutti, Mateus J; Alves, Eduardo da Sliva; Michael, Scott; Ding, Ding; Stamatakis, Emmanuel; Edwards, Kate M

    2017-12-01

    Yoga is promoted as an anti-stress activity, however, little is known about the mechanisms through which it acts. The present study investigated the acute effects of a hatha yoga session, displayed on a video, on the response to and recovery from an acute psychological stressor. Twenty-four healthy young adults took part in a counterbalanced, randomized-crossover trial, with a yoga and a control condition (watching TV). Participants attended the laboratory in the afternoon on two days and each session comprised a baseline, control or yoga task, stress task and recovery. Blood pressure (BP), heart rate (HR) and salivary cortisol responses were measured. State cognitive- and somatic-anxiety along with self-confidence were assessed before and after the stressor. Although no difference in the BP or HR responses to stress were found between conditions, systolic BP (p=0.047) and diastolic BP (p=0.018) recovery from stress were significantly accelerated and salivary cortisol reactivity was significantly lower (p=0.01) in the yoga condition. A yoga session also increased self-confidence (p=0.006) in preparation for the task and after completion. Moreover, self-confidence reported after the stress task was considered debilitative towards performance in the control condition, but remained facilitative in the yoga condition. Our results show that a single video-instructed session of hatha yoga was able to improve stress reactivity and recovery from an acute stress task in healthy individuals. These positive preliminary findings encourage further investigation in at-risk populations in which the magnitude of effects may be greater, and support the use of yoga for stress reactivity and recovery. Copyright © 2017 Elsevier Ltd. All rights reserved.

  14. A double blind, placebo-controlled, randomized crossover study of the acute metabolic effects of olanzapine in healthy volunteers.

    Directory of Open Access Journals (Sweden)

    Vance L Albaugh

    Full Text Available Atypical antipsychotics exhibit metabolic side effects including diabetes mellitus and obesity. The adverse events are preceded by acute worsening of oral glucose tolerance (oGTT along with reduced plasma free fatty acids (FFA and leptin in animal models. It is unclear whether the same acute effects occur in humans.A double blind, randomized, placebo-controlled crossover trial was conducted to examine the potential metabolic effects of olanzapine in healthy volunteers. Participants included male (8 and female (7 subjects [18-30 years old, BMI 18.5-25]. Subjects received placebo or olanzapine (10 mg/day for three days prior to oGTT testing. Primary endpoints included measurement of plasma leptin, oral glucose tolerance, and plasma free fatty acids (FFA. Secondary metabolic endpoints included: triglycerides, total cholesterol, high- and low-density lipoprotein cholesterol, heart rate, blood pressure, body weight and BMI. Olanzapine increased glucose Area Under the Curve (AUC by 42% (2808±474 vs. 3984±444 mg/dl·min; P = 0.0105 during an oGTT. Fasting plasma leptin and triglycerides were elevated 24% (Leptin: 6.8±1.3 vs. 8.4±1.7 ng/ml; P = 0.0203 and 22% (Triglycerides: 88.9±10.1 vs. 108.2±11.6 mg/dl; P = 0.0170, whereas FFA and HDL declined by 32% (FFA: 0.38±0.06 vs. 0.26±0.04 mM; P = 0.0166 and 11% (54.2±4.7 vs. 48.9±4.3 mg/dl; P = 0.0184, respectively after olanzapine. Other measures were unchanged.Olanzapine exerts some but not all of the early endocrine/metabolic changes observed in rodent models of the metabolic side effects, and this suggest that antipsychotic effects are not limited to perturbations in glucose metabolism alone. Future prospective clinical studies should focus on identifying which reliable metabolic alterations might be useful as potential screening tools in assessing patient susceptibility to weight gain and diabetes caused by atypical antipsychotics.ClinicalTrials.gov NCT00741026.

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

    Science.gov (United States)

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

    2009-06-01

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

  16. 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

  17. The effect of carbohydrate mouth rinse on performance, biochemical and psychophysiological variables during a cycling time trial: a crossover randomized trial.

    Science.gov (United States)

    Ferreira, Amanda M J; Farias-Junior, Luiz F; Mota, Thaynan A A; Elsangedy, Hassan M; Marcadenti, Aline; Lemos, Telma M A M; Okano, Alexandre H; Fayh, Ana P T

    2018-01-01

    The hypothesis of the central effect of carbohydrate mouth rinse (CMR) on performance improvement in a fed state has not been established, and its psychophysiological responses have not yet been described. The aim of this study was to evaluate the effect of CMR in athletes fed state on performance, biochemical and psychophysiological responses compared to ad libitum water intake. Eleven trained male cyclists completed a randomized, crossover trial, which consisted of a 30 km cycle ergometer at self-selected intensity and in a fed state. Subjects were under random influence of the following interventions: CMR with a 6% unflavored maltodextrin solution; mouth rinsing with a placebo solution (PMR); drinking "ad libitum" (DAL). The time for completion of the test (min), heart rate (bpm) and power (watts), rating of perceived exertion (RPE), affective response, blood glucose (mg/dL) and lactate (mmol/DL), were evaluated before, during and immediately after the test, while insulin (uIL/mL), cortisol (μg/dL) and creatine kinase (U/L) levels were measured before, immediately after the test and 30 min after the test. Time for completion of the 30 km trial did not differ significantly among CMR, PMR and DAL interventions (means = 54.5 ± 2.9, 54.7 ± 2.9 and 54.5 ± 2.5 min, respectively; p  = 0.82). RPE and affective response were higher in DAL intervention ( p  creatine kinase responses showed no significant difference among interventions. In a fed state, CMR has not caused metabolic changes, and it has not improved physical performance compared to ad libitum water intake, but demonstrated a possible central effect. ReBec registration number: RBR-4vpwkg. Available in http://www.ensaiosclinicos.gov.br/rg/?q=RBR-4vpwkg.

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

    Science.gov (United States)

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

    2018-03-01

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

  19. The effect of benzocaine and ketoprofen gels on pain during fixed orthodontic appliance treatment: a randomised, double-blind, crossover trial.

    Science.gov (United States)

    Eslamian, Ladan; Borzabadi-Farahani, Ali; Gholami, Hadi

    2016-05-01

    To compare the analgesic effect of topical benzocaine (5%) and ketoprofen (1.60 mg/mL) after 2 mm activation of 7 mm long delta loops used for maxillary en-masse orthodontic space closure. Twenty patients (seven males, 13 females, 15-25 years of age, mean age of 19.5 years) participated in a randomised crossover, double-blind trial. After appliance activation, participants were instructed to use analgesic gels and record pain perception at 2, 6, 24 hours and 2, 3 and 7 days (at 18.00 hrs), using a visual analogue scale ruler (VAS, 0-4). Each patient received all three gels (benzocaine, ketoprofen, and a control (placebo)) randomly, but at three different appliance activation visits following a wash-over gap of one month. After the first day, the patients were instructed to repeat gel application twice a day at 10:00 and 18:00 hrs for three days. The recorded pain scores were subjected to non-parametric analysis. The highest pain was recorded at 2 and 6 hours. Pain scores were significantly different between the three groups (Kruskal-Wallis test, p 0.05). A significant pain reduction was observed following the use of ketoprofen when tested against a control gel (placebo). The highest pain scores were experienced in patients administered the placebo and the lowest scores in patients who applied ketoprofen gel. Benzocaine had an effect mid-way between ketoprofen and the placebo. The highest pain scores were recorded 2 hours following force application, which decreased to the lowest scores after 7 days.

  20. An active video game intervention does not improve physical activity and sedentary time of children at-risk for developmental coordination disorder: a crossover randomized trial.

    Science.gov (United States)

    Howie, E K; Campbell, A C; Straker, L M

    2016-03-01

    Children with developmental coordination disorder (DCD) are highly inactive and sedentary. The purpose of this study was to assess the impact of a home-based active video game intervention on objectively measured physical activity and sedentary behaviour in children at risk for DCD. In a crossover randomized clinical trial, 21 children (mean age 11.0, SD 1.0; n = 11 girls) in Perth, Western Australia participated in two 16-week periods: no active video games (AVGs) control period and AVGs intervention period. Two active input consoles were provided to participants along with a selection of non-violent AVGs for participants to play at home. Participants wore accelerometers at baseline and following each period to determine minutes of sedentary, light, moderate and vigorous times in addition to self-reported types of activities in a diary. Linear mixed models, adjusted for the order of periods, compared physical activity and sedentary time during the last week of each period. There were no significant differences between the intervention and control periods in time spent in sedentary (decrease of -1.0 min/day during the intervention period, 95%CI -12.1, 10.1), light (increase of 2.2 min/day, 95%CI -8.8, 13.2), moderate (decrease of 0.7 min/day, 95%CI -4.6, 3.3) or vigorous (decrease of -0.6 min/day, 95%CI -1.6, 0.4). Among children at risk for DCD, participating in this AVG intervention did not improve objectively measured physical activity and sedentary time. © 2015 John Wiley & Sons Ltd.

  1. Sodium valproate in the treatment of aggressive behavior in patients with dementia--a randomized placebo controlled clinical trial

    NARCIS (Netherlands)

    Sival, Rob C.; Haffmans, P. M. Judith; Jansen, Paul A. F.; Duursma, Sijmen A.; Eikelenboom, Piet

    2002-01-01

    OBJECTIVES: The efficacy and tolerability of sodium valproate 2 x 240 mg compared to placebo were investigated in aggressive behavior in dementia. DESIGN: A randomized, placebo controlled, double-blind cross-over design. The trial included a baseline period (one week); a placebo period (three

  2. Factor VIIa response to a fat-rich meal does not depend on fatty acid composition: A randomized controlled trial

    NARCIS (Netherlands)

    Mennen, L.; Maat, M. de; Meijer, G.; Zock, P.; Grobbee, D.; Kok, F.; Kluft, C.; Schouten, E.

    1998-01-01

    A fat-rich meal increases activated factor VII (FVIIa), but it is not clear whether this increase depends on the fatty acid composition of the meal. Therefore, we studied the FVIIa response to fat-rich meals with different fatty acid composition in a randomized controlled crossover trial and

  3. Efficacy of piracetam in the treatment of tardive dyskinesia in schizophrenic patients: a randomized, double-blind, placebo-controlled crossover study.

    Science.gov (United States)

    Libov, Igor; Miodownik, Chanoch; Bersudsky, Yuly; Dwolatzky, Tzvi; Lerner, Vladimir

    2007-07-01

    Piracetam is a potent antioxidant, a cerebral neuroprotector, a neuronal metabolic enhancer, and a brain integrative agent. More than 20 years ago, an intravenous preparation of piracetam demonstrated an improvement in the symptoms of tardive dyskinesia. The aim of our study was to reexamine the efficacy of piracetam in the treatment of tardive dyskinesia using an oral preparation. The study was conducted at the Be'er Sheva Mental Health Center from May 2003 to December 2004 and involved a 9-week, double-blind, crossover, placebo-controlled trial assessing 40 DSM-IV schizophrenic and schizo-affective patients with DSM-IV-TR tardive dyskinesia. All study subjects received their usual antipsychotic treatment. Initially, subjects were randomly assigned to receive 4 weeks of treatment with either piracetam (4800 mg/day) or placebo. Thereafter, following a washout period of 1 week, they entered the crossover phase of the study for a further 4 weeks. The change in score of the Extrapyramidal Symptom Rating Scale from baseline to the study endpoint was the primary outcome measure. The mean decrease in score from baseline to endpoint in the clinical global impression subscale in patients treated with piracetam was 1.1 points compared to 0.1 points in the placebo group (p = .004). The mean decrease in the tardive parkinsonism subscale was 8.7 points in patients treated with piracetam and 0.6 points in those on placebo (p = .001). The mean decrease in the tardive dyskinesia subscale was 3.0 points in the piracetam group in contrast to deterioration of condition in the placebo group by -0.2 points (p = .003). Piracetam appears to be effective in reducing symptoms of tardive dyskinesia. The specific mechanism by which piracetam may attenuate symptoms of tardive dyskinesia needs to be further evaluated. ClinicalTrials.gov identifier NCT00190008.

  4. The Impact of Methylphenidate on Motor Performance in Children with both Attention Deficit Hyperactivity Disorder and Developmental Coordination Disorder: A Randomized Double-Blind Crossover Clinical Trial

    Directory of Open Access Journals (Sweden)

    Robabeh Soleimani

    2017-07-01

    Full Text Available Background: Children with attention deficit hyperactivity disorder/developmental coordination disorder (ADHD/DCD suffer from problems associated with gross and fine motor skills. There is no effective pharmacological therapy for such patients. We aimed to assess the impact of methylphenidate (MPH on motor performance of children with ADHD/DCD. Methods: In this double-blind placebo-controlled, 17 children (12 boys with ADHD/DCD with a mean age of 7 years 6 months were recruited in Shafa Hospital, Rasht, Iran. The response was defined as ≥25% reduction in the total score of ADHD rating scale-IV from the baseline. Sixteen boys entered phase 2 of the study in which the impact of MPH on motor function was determined through a crossover randomized clinical trial. Eligible individuals were scheduled for baseline and two assessment visits after a one-week period of intervention. We used the short form of Bruininks-Oseretsky test (BOT-2 to identify the disability of motor function. Children were randomly assigned to receive MPH or inert ingredients (placebo. In the second period, medication (MPH/placebo was crossed over. The effects of MPH were analyzed using χ2 test for related samples to compare the performance during baseline, placebo, and MPH trials. The results were analyzed using the SPSS software version 16.0. Results: The mean minimal effective dose of MPH per day was 17.3 mg (0.85 mg/kg. Children with higher ADHD rating scale had a significantly lower standard score in BOT-2 (P=0.03. Following MPH intake, 26.6% of the children showed clinically significant improvement in motor function. However, the improvement was not statistically different between the MPH and placebo. Conclusion: Although MPH improved ADHD symptoms, problems with motor performance still remained. Further work is required to determine the probable effects of MPH in a higher dosage or in different subtypes of ADHD. Trial Registration Number: IRCT201107071483N2

  5. Acute effect of Clitoria ternatea flower beverage on glycemic response and antioxidant capacity in healthy subjects: a randomized crossover trial.

    Science.gov (United States)

    Chusak, Charoonsri; Thilavech, Thavaree; Henry, Christiani Jeyakumar; Adisakwattana, Sirichai

    2018-01-08

    Clitoria ternatea L., a natural food-colorant containing anthocyanin, demonstrated antioxidant and antihyperglycemic activity. The aim of this study was to determine the effects of Clitoria ternatea flower extract (CTE) on postprandial plasma glycemia response and antioxidant status in healthy men. In a randomized, crossover study, 15 healthy men (ages 22.53 ± 0.30 years; with body mass index of 21.57 ± 0.54 kg/m 2 ) consumed five beverages: (1) 50 g sucrose in 400 mL water; (2) 1 g CTE in 400 mL of water; (3) 2 g CTE in 400 mL of water; (4) 50 g sucrose and 1 g CTE in 400 mL of water; and (5) 50 g sucrose and 2 g CTE in 400 mL of water. Incremental postprandial plasma glucose, insulin, uric acid, antioxidant capacities and lipid peroxidation were measured during 3 h of administration. After 30 min ingestion, the postprandial plasma glucose and insulin levels were suppressed when consuming sucrose plus 1 g and 2 g CTE. In addition, consumption of CTE alone did not alter plasma glucose and insulin concentration in the fasting state. The significant increase in plasma antioxidant capacity (ferric reducing ability of plasma (FRAP), oxygen radical absorbance capacity (ORAC), trolox equivalent antioxidant capacity (TEAC), and protein thiol) and the decrease in malondialdehyde (MDA) level were observed in the subjects who received 1 g and 2 g CTE. Furthermore, consumption of CTE protected sucrose-induced reduction in ORAC and TEAC and increase in plasma MDA. These findings suggest that an acute ingestion of CTE increases plasma antioxidant capacity without hypoglycemia in the fasting state. It also improves postprandial glucose, insulin and antioxidant status when consumed with sucrose. Thai Clinical Trials Registry: TCTR20170609003 . Registered 09 September 2017. 'retrospectively registered'.

  6. The effects of oral sucrose on pain due to nasogastric tube insertion in premature infants: A crossover clinical trial

    Directory of Open Access Journals (Sweden)

    Jebreili M

    2014-11-01

    Full Text Available Background and Objective: Pain in neonates may have adverse impacts. Therefore, relieving pain through harmless, simple, and applicable methods, in order to prevent its dangerous consequences, is of great importance. The aim of the present study is to determine the impact of oral sucrose on relieving nasogastric tube insertion pain in premature neonates. Materials and Method: The present study is a crossover clinical trial on 38 preterm infants (gestational age between 28-34 weeks hospitalized in Bistonoh-e-Bahman Hospital, Tabriz, Iran, in 2013. The subjects were selected by convenience sampling and divided into two groups using randomized block design. In the first group, nasogastric tube insertion was carried out in the routine way for the first time, and for the second time, by administration of oral sucrose. In the second group, the procedure was performed in the reverse order of that in the first group. In both groups the emerging pain was measured by the Premature Infant Pain Profile (PIPP tool 2 minutes before, during, and 5 minutes after the procedure. Data were analyzed using, chi-square t-test, Students' independent test, paired t-test, and repeated measures ANOVA in SPSS version 18 to examine the trend of change in pain in time. P values of less than 0.05 were considered statistically significant. Results: The results showed that oral sucrose reduces the pain response of infants. The mean pain score during the insertion of nasogastric tube and administration of oral sucrose was 5.95 ± 2.35 and during routine procedures was 9.93 ± 2.89 (P < 0.001. The mean pain score 5 minutes after insertion of nasogastric tube with administration of oral sucrose was 3.66 ± 0.57 and routine procedure was 6.38 ± 0.83 (P = 0.017. Conclusion: It was revealed that oral sucrose can relieve pain caused by nasogastric tube insertion. Therefore, its implementation as a harmless and simple method can reduce pain in preterm infants.

  7. 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

  8. Effects of a new combination of nutraceuticals on postmenopausal symptoms and metabolic profile: a crossover, randomized, double-blind trial

    Directory of Open Access Journals (Sweden)

    Trimarco V

    2016-10-01

    Full Text Available Valentina Trimarco,1 Francesco Rozza,2 Raffaele Izzo,3 Vincenzo De Leo,4 Valentina Cappelli,4 Carla Riccardi,1 Costantino Di Carlo1 1Department of Neuroscience, Reproductive Sciences and Dentistry, 2Department of Biomedical Sciences, 3Department of Translational Medical Sciences, Federico II University of Naples, Naples, 4Department of Molecular and Developmental Medicine, University of Siena, Siena, Italy Objectives: This study was designed to measure the beneficial effects of a combination of nutraceutics (NUT; AkP04, Morestril®, Akademy Pharma containing soy isoflavones (80 mg, dry extract of Angelica sinensis (50 mg, dry extract of Morus alba leaf (200 mg and magnesium (56.25 mg in the relief of somatic, psychological, and urogenital symptoms in postmenopausal patients, using the validated Menopause Rating Scale (MRS and cardiovascular risk factors.Materials and methods: A total of 43 symptomatic postmenopausal women (MRS ≥20 were enrolled in a crossover trial. After a 2-week run-in period, patients were randomized into two arms. One arm received probiotics plus placebo over 4 weeks, followed by a 4-week treatment with probiotics plus NUT. The second arm received probiotics plus NUT for 4 weeks, followed by a 4-week treatment with probiotics plus placebo.Results: After the NUT period, participants showed a significant reduction in MRS score (18.4±5.4 in comparison to baseline (28.4±5 and the placebo period (28±5.2 (P<0.0001 for both comparisons. Furthermore, at the end of the active-treatment period, we observed a significant reduction in triglycerides, total and low-density lipoprotein cholesterol plasma levels and an increase in high-density lipoprotein cholesterol plasma concentration versus baseline and versus placebo (all P<0.04. Moreover, during the NUT period, we detected a significant reduction in diastolic blood pressure in comparison to baseline, but not in comparison to the placebo period.Conclusion: This NUT combination was

  9. 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

    2018-08-01

    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

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

    Science.gov (United States)

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

    2017-10-04

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

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

    Directory of Open Access Journals (Sweden)

    Pleun C M van Poppel

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

  12. Lack of interaction between sensing-intuitive learning styles and problem-first versus information-first instruction: a randomized crossover trial.

    Science.gov (United States)

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

    2009-03-01

    Adaptation to learning styles has been proposed to enhance learning. We hypothesized that learners with sensing learning style would perform better using a problem-first instructional method while intuitive learners would do better using an information-first method. Randomized, controlled, crossover trial. Resident ambulatory clinics. 123 internal medicine residents. Four Web-based modules in ambulatory internal medicine were developed in both "didactic" (information first, followed by patient problem and questions) and "problem" (case and questions first, followed by information) format. Knowledge posttest, format preference, learning style (Index of Learning Styles). Knowledge scores were similar between the didactic (mean +/- standard error, 83.0 +/- 0.8) and problem (82.3 +/- 0.8) formats (p = .42; 95% confidence interval [CI] for difference, -2.3 to 0.9). There was no difference between formats in regression slopes of knowledge scores on sensing-intuitive scores (p = .63) or in analysis of knowledge scores by styles classification (sensing 82.5 +/- 1.0, intermediate 83.7 +/- 1.2, intuitive 81.0 +/- 1.5; p = .37 for main effect, p = .59 for interaction with format). Format preference was neutral (3.2 +/- 0.2 [1 strongly prefers didactic, 6 strongly prefers problem], p = .12), and there was no association between learning styles and preference (p = .44). Formats were similar in time to complete modules (43.7 +/- 2.2 vs 43.2 +/- 2.2 minutes, p = .72). Starting instruction with a problem (versus employing problems later on) may not improve learning outcomes. Sensing and intuitive learners perform similarly following problem-first and didactic-first instruction. Results may apply to other instructional media.

  13. Pre-Meal Effect of Whey Proteins on Metabolic Parameters in Subjects with and without Type 2 Diabetes: A Randomized, Crossover Trial

    Directory of Open Access Journals (Sweden)

    Ann Bjørnshave

    2018-01-01

    Full Text Available Diabetic dyslipidemia with elevated postprandial triglyceride (TG responses is characteristic in type 2 diabetes (T2D. Diet and meal timing can modify postprandial lipemia (PPL. The impact of a pre-meal of whey proteins (WP on lipid metabolism is unidentified. We determined whether a WP pre-meal prior to a fat-rich meal influences TG and apolipoprotein B-48 (ApoB-48 responses differentially in patients with and without T2D. Two matched groups of 12 subjects with and without T2D accomplished an acute, randomized, cross-over trial. A pre-meal of WP (20 g or water (control was consumed 15 min before a fat-rich meal (supplemented with 20 g WP in case of water pre-meal. Postprandial responses were examined during a 360-min period. A WP pre-meal significantly increased postprandial concentrations of insulin (P < 0.0001, glucagon (P < 0.0001 and glucose-dependent insulinotropic peptide (GIP (P < 0.0001 in subjects with and without T2D. We detected no effects of the WP pre-meal on TG, ApoB-48, or non-esterified fatty acids (NEFA responses to the fat-rich meal in either group. Paracetamol absorption i.e. gastric emptying was delayed by the WP pre-meal (P = 0.039. In conclusion, the WP pre-meal induced similar hormone and lipid responses in subjects with and without T2D. Thus, the WP pre-meal enhanced insulin, glucagon and GIP responses but did not influence lipid or glucose responses. In addition, we demonstrated that a WP pre-meal reduced gastric emptying in both groups.

  14. Actual driving performance and psychomotor function in healthy subjects after acute and subchronic treatment with escitalopram, mirtazapine, and placebo: a crossover trial.

    Science.gov (United States)

    Wingen, Marleen; Bothmer, John; Langer, Stefan; Ramaekers, Johannes G

    2005-04-01

    The effects of escitalopram 10 to 20 mg/day and mirtazapine 30 to 45 mg/day on actual driving and psychomotor performance of 18 healthy subjects were determined in a randomized, double-blind, placebo-controlled, multiple-dose, 3-way crossover trial. Each treatment period lasted for 15 days and was separated from the next period by a washout period of at least 13 days. Subjects received an evening dose of escitalopram 10 mg, mirtazapine 30 mg, or placebo from days 1 to 7 and an evening dose of escitalopram 20 mg, mirtazapine 45 mg, or placebo from days 8 to 15. On days 2, 9, and 16, reflecting acute period, dose increase, and steady state, respectively, the Road Tracking Test was performed. The main parameter was standard deviation of lateral position. Psychomotor performance was also assessed on days 2, 9, and 16 by laboratory computer tasks. Subjective sleep quality was measured with the Groninger Sleep Quality Scale, and mood was measured by visual analogue scales. Treatment differences were apparent during the acute treatment period, in which subjects treated with mirtazapine 30 mg performed less well on the driving test as compared to placebo. The Divided Attention Task results also revealed a significant increase in tracking error after a single dose of mirtazapine 30 mg as compared to placebo. Mirtazapine decreased feelings of alertness and contentedness. Mirtazapine did not affect performance on days 9 and 16 of treatment. Escitalopram did not affect driving, psychomotor performance, or subjective mood throughout treatment. Driving performance, as well as psychomotor functioning, was not affected by escitalopram treatment in healthy subjects. Driving performance was significantly impaired after ingestion of mirtazapine 30 mg during the acute treatment period.

  15. Effects on peripheral and central blood pressure of cocoa with natural or high-dose theobromine: a randomized, double-blind crossover trial.

    Science.gov (United States)

    van den Bogaard, Bas; Draijer, Richard; Westerhof, Berend E; van den Meiracker, Anton H; van Montfrans, Gert A; van den Born, Bert-Jan H

    2010-11-01

    Flavanol-rich cocoa products have been reported to lower blood pressure. It has been suggested that theobromine is partially responsible for this effect. We tested whether consumption of flavanol-rich cocoa drinks with natural or added theobromine could lower peripheral and central blood pressure. In a double-blind, placebo-controlled 3-period crossover trial we assigned 42 healthy individuals (age 62±4.5 years; 32 men) with office blood pressure of 130 to 159 mm Hg/85 to 99 mm Hg and low added cardiovascular risk to a random treatment sequence of dairy drinks containing placebo, flavanol-rich cocoa with natural dose consisting of 106 mg of theobromine, or theobromine-enriched flavanol-rich cocoa with 979 mg of theobromine. Treatment duration was 3 weeks with a 2-week washout. The primary outcome was the difference in 24-hour ambulatory systolic blood pressure between placebo and active treatment after 3 weeks. The difference in central systolic blood pressure between placebo and active treatment was a secondary outcome. Treatment with theobromine-enriched cocoa resulted in a mean±SE of 3.2±1.1 mm Hg higher 24-hour ambulatory systolic blood pressure compared with placebo (Ptheobromine-enriched cocoa, laboratory peripheral systolic blood pressure was not different from placebo, whereas central systolic blood pressure was 4.3±1.4 mm Hg lower (P=0.001). Natural dose theobromine cocoa did not significantly change either 24-hour ambulatory or central systolic blood pressure compared with placebo. In conclusion, theobromine-enriched cocoa significantly increased 24-hour ambulatory systolic blood pressure while lowering central systolic blood pressure.

  16. Consuming High-Carotenoid Fruit and Vegetables Influences Skin Yellowness and Plasma Carotenoids in Young Women: A Single-Blind Randomized Crossover Trial.

    Science.gov (United States)

    Pezdirc, Kristine; Hutchesson, Melinda J; Williams, Rebecca L; Rollo, Megan E; Burrows, Tracy L; Wood, Lisa G; Oldmeadow, Christopher; Collins, Clare E

    2016-08-01

    Consumption of dietary carotenoids from fruits and vegetables (F/V) leads to accumulations in human skin, altering skin yellowness. The influence of the quantity of F/V consumed on skin yellowness and plasma carotenoid concentrations has not been examined previously. To compare the influence of consuming high-carotenoid-containing F/V (HCFV) (176,425 μg beta carotene/wk) vs low-carotenoid F/V (LCFV) (2,073 μg beta carotene/wk) on skin yellowness and plasma carotenoid concentrations, over 4 weeks. A single-blind randomized controlled crossover trial from October 2013 to March 2014. Thirty women were randomized to receive 7 daily servings of HCFV or LCFV for 4 weeks. Following a 2-week washout period they followed the alternate intervention. Skin color (Commission Internationale de l'Eclairage L*a*b* color space, where L* represents skin lightness and positive values of a* and b* represent degrees of redness and yellowness, respectively) was assessed by reflectance spectroscopy in both sun-exposed and nonexposed skin areas. Fasting plasma carotenoids were determined by high-performance liquid chromatography, before and after each intervention period. Linear mixed models were used to determine the HCFV and LCFV response on skin color and plasma carotenoids, adjusting for intervention order, time, and interaction between baseline differences and time. There were no significant differences in mean daily fruit (P=0.42) and vegetable (P=0.17) intakes between HCFV and LCFV groups. Dietary alpha carotene, beta carotene, lutein, and beta cryptoxanthin intakes were significantly different between the two groups (Pcarotenoid concentrations were significantly higher following HCFV than LCFV over 4 weeks. Copyright © 2016 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

  17. Genetic ancestry in relation to the metabolic response to a US versus traditional Mexican diet: a randomized crossover feeding trial among women of Mexican descent.

    Science.gov (United States)

    Santiago-Torres, M; De Dieu Tapsoba, J; Kratz, M; Lampe, J W; Breymeyer, K L; Levy, L; Song, X; Villaseñor, A; Wang, C-Y; Fejerman, L; Neuhouser, M L; Carlson, C S

    2017-03-01

    Certain populations with a large proportion of indigenous American (IA) genetic ancestry may be evolutionarily adapted to traditional diets high in legumes and complex carbohydrates, and may have a detrimental metabolic response to US diets high in refined carbohydrates and added sugars. We tested whether IA ancestry modified the metabolic response to a US versus traditional Mexican diet in a controlled dietary intervention. First and second generation Mexican immigrant women (n=53) completed a randomized crossover feeding trial testing the effects of a US versus traditional Mexican diet. The metabolic response to the diets was measured by fasting serum concentrations of glucose, insulin, insulin-like growth factor-1 (IGF-1), IGF-binding protein-3 (IGFBP-3), adiponectin, C-reactive protein, interleukin-6 and computed homeostasis model assessment for insulin resistance (HOMA IR ). Blood collected at baseline was used for genotyping, and estimation of African, European and IA ancestries with the use of 214 ancestry informative markers. The genetic ancestral background was 56% IA, 38% European and 6% African. Women in the highest IA ancestry tertile (>62%) were shorter in height, less educated and less acculturated to the US lifestyle, and tended to have higher waist-to-hip ratio compared with women in the middle and lowest IA ancestry tertiles, respectively. Compared with the US diet, the traditional Mexican diet tended to reduce glucose, insulin, IGF-1, IGFBP-3 and HOMA IR among women in the middle IA ancestry group (IA ancestry ⩽45-62%), whereas having no effect on biomarkers related to inflammation. We observed modest interactions between IA ancestry and the metabolic response to a US versus traditional Mexican diet among Mexican immigrant women.

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

    Directory of Open Access Journals (Sweden)

    Florian Egger

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

  19. Portable electronic vision enhancement systems in comparison with optical magnifiers for near vision activities: an economic evaluation alongside a randomized crossover trial.

    Science.gov (United States)

    Bray, Nathan; Brand, Andrew; Taylor, John; Hoare, Zoe; Dickinson, Christine; Edwards, Rhiannon T

    2017-08-01

    To determine the incremental cost-effectiveness of portable electronic vision enhancement system (p-EVES) devices compared with optical low vision aids (LVAs), for improving near vision visual function, quality of life and well-being of people with a visual impairment. An AB/BA randomized crossover trial design was used. Eighty-two participants completed the study. Participants were current users of optical LVAs who had not tried a p-EVES device before and had a stable visual impairment. The trial intervention was the addition of a p-EVES device to the participant's existing optical LVA(s) for 2 months, and the control intervention was optical LVA use only, for 2 months. Cost-effectiveness and cost-utility analyses were conducted from a societal perspective. The mean cost of the p-EVES intervention was £448. Carer costs were £30 (4.46 hr) less for the p-EVES intervention compared with the LVA only control. The mean difference in total costs was £417. Bootstrapping gave an incremental cost-effectiveness ratio (ICER) of £736 (95% CI £481 to £1525) for a 7% improvement in near vision visual function. Cost per quality-adjusted life year (QALY) ranged from £56 991 (lower 95% CI = £19 801) to £66 490 (lower 95% CI = £23 055). Sensitivity analysis varying the commercial price of the p-EVES device reduced ICERs by up to 75%, with cost per QALYs falling below £30 000. Portable electronic vision enhancement system (p-EVES) devices are likely to be a cost-effective use of healthcare resources for improving near vision visual function, but this does not translate into cost-effective improvements in quality of life, capability or well-being. © 2016 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation and European Association for Vision & Eye Research.

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

    Science.gov (United States)

    Ghorbanzadeh, Roghayeh; Pourakbari, Babak; Bahador, Abbas

    2015-04-01

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

  1. Safety and Observations from a Placebo-Controlled, Crossover Study to Assess Use of Autologous Umbilical Cord Blood Stem Cells to Improve Symptoms in Children with Autism.

    Science.gov (United States)

    Chez, Michael; Lepage, Christopher; Parise, Carol; Dang-Chu, Ashley; Hankins, Andrea; Carroll, Michael

    2018-04-01

    The aim of this exploratory study was to assess the safety and clinical effects of autologous umbilical cord blood (AUCB) infusion in children with idiopathic autism spectrum disorder (ASD). Twenty-nine children 2 to 6 years of age with a confirmed diagnosis of ASD participated in this randomized, blinded, placebo-controlled, crossover trial. Participants were randomized to receive AUCB or placebo, evaluated at baseline, 12, and 24 weeks, received the opposite infusion, then re-evaluated at the same time points. Evaluations included assessments of safety, Expressive One Word Picture Vocabulary Test, 4th edition, Receptive One Word Picture Vocabulary Test, 4th edition, Clinical Global Impression, Stanford-Binet Fluid Reasoning and Knowledge, and the Vineland Adaptive Behavior and Socialization Subscales. Generalized linear models were used to assess the effects of the response variables at the 12- and 24-week time periods under each condition (AUCB, placebo). There were no serious adverse events. There were trends toward improvement, particularly in socialization, but there were no statistically significant differences for any endpoints. The results of this study suggest that autologous umbilical cord infusions are safe for children with ASD. Tightly controlled trials are necessary to further progress the study of AUCB for autism. Stem Cells Translational Medicine 2018;7:333-341. © 2018 The Authors Stem Cells Translational Medicine published by Wiley Periodicals, Inc. on behalf of AlphaMed Press.

  2. Effects of breaking up sitting on adolescents' postprandial glucose after consuming meals varying in energy: a cross-over randomised trial.

    Science.gov (United States)

    Fletcher, Elly A; Salmon, Jo; McNaughton, Sarah A; Orellana, Liliana; Wadley, Glenn D; Bruce, Clinton; Dempsey, Paddy C; Lacy, Kathleen E; Dunstan, David W

    2018-03-01

    To explore the impact of uninterrupted sitting versus sitting with resistance-type activity breaks on adolescents' postprandial glucose responses while consuming a diet varying in energy. Cross-over randomised trial. Thirteen healthy participants (16.4±1.3years) completed a four-treatment cross-over trial: (1) uninterrupted sitting+high-energy diet; (2) sitting with breaks+high-energy diet; (3) uninterrupted sitting+standard-energy diet; and (4) sitting with breaks+standard-energy diet. For all four conditions, two identical meals were consumed; at 0h and 3h. A continuous glucose monitoring system (CGM) recorded interstitial glucose concentrations every five minutes. Linear mixed models examined differences in glucose positive incremental area under the curve (iAUC) and total AUC between the sitting and diet conditions for the first meal, second meal and entire trial period. Compared to the uninterrupted sitting conditions, the breaks condition elicited a 36.0mmol/L/h (95%CI 6.6-65.5) and 35.9mmol/L/h (95%CI 6.6-65.5) lower iAUC response after the first and second meal, respectively, but not for the entire trial period or for total AUC. Compared to the standard-energy diet, the high-energy diet elicited a 55.0mmol/L/h (95%CI 25.8-84.2) and 75.7mmol/L/h (95%CI 8.6-142.7) higher iAUC response after the first meal and entire trial, respectively. Similar response to the high-energy diet were observed for total AUC. According to iAUC, interrupting sitting had a significant effect on lowering postprandial glucose for both dietary conditions, however, it was not significant when examining total AUC. Larger studies are needed to confirm these findings. ACTRN12615001145594. Copyright © 2017 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  3. Time-Efficiency Analysis Comparing Digital and Conventional Workflows for Implant Crowns: A Prospective Clinical Crossover Trial.

    Science.gov (United States)

    Joda, Tim; Brägger, Urs

    2015-01-01

    To compare time-efficiency in the production of implant crowns using a digital workflow versus the conventional pathway. This prospective clinical study used a crossover design that included 20 study participants receiving single-tooth replacements in posterior sites. Each patient received a customized titanium abutment plus a computer-aided design/computer-assisted manufacture (CAD/CAM) zirconia suprastructure (for those in the test group, using digital workflow) and a standardized titanium abutment plus a porcelain-fused-to-metal crown (for those in the control group, using a conventional pathway). The start of the implant prosthetic treatment was established as the baseline. Time-efficiency analysis was defined as the primary outcome, and was measured for every single clinical and laboratory work step in minutes. Statistical analysis was calculated with the Wilcoxon rank sum test. All crowns could be provided within two clinical appointments, independent of the manufacturing process. The mean total production time, as the sum of clinical plus laboratory work steps, was significantly different. The mean ± standard deviation (SD) time was 185.4 ± 17.9 minutes for the digital workflow process and 223.0 ± 26.2 minutes for the conventional pathway (P = .0001). Therefore, digital processing for overall treatment was 16% faster. Detailed analysis for the clinical treatment revealed a significantly reduced mean ± SD chair time of 27.3 ± 3.4 minutes for the test group compared with 33.2 ± 4.9 minutes for the control group (P = .0001). Similar results were found for the mean laboratory work time, with a significant decrease of 158.1 ± 17.2 minutes for the test group vs 189.8 ± 25.3 minutes for the control group (P = .0001). Only a few studies have investigated efficiency parameters of digital workflows compared with conventional pathways in implant dental medicine. This investigation shows that the digital workflow seems to be more time-efficient than the

  4. An Organic Khorasan Wheat-Based Replacement Diet Improves Risk Profile of Patients with Acute Coronary Syndrome: A Randomized Crossover Trial

    Directory of Open Access Journals (Sweden)

    Anne Whittaker

    2015-05-01

    Full Text Available Khorasan wheat is an ancient grain with previously reported health benefits in clinically healthy subjects. The aim of this study was to examine whether a replacement diet, thereby substituting all other cereal grains, with products made with organic khorasan wheat could provide additive protective effects in reducing lipid, oxidative and inflammatory risk factors, in patients with Acute Coronary Syndromes (ACS in comparison to a similar replacement diet using products made from organic modern wheat. A randomized double-blinded crossover trial with two intervention phases was conducted on 22 ACS patients (9 F; 13 M. The patients were assigned to consume products (bread, pasta, biscuits and crackers made either from organic semi-whole khorasan wheat or organic semi-whole control wheat for eight weeks in a random order. On average, patients ingested 62.0 g dry weight (DW day−1 khorasan or control semolina; and 140.5 g DW day−1 khorasan or control flour, respectively. An eight-week washout period was implemented between the respective interventions. Blood analyses were performed both at the beginning and end of each intervention phase; thereby permitting a comparison of both the khorasan and control intervention phases, respectively, on circulatory risk factors for the same patient. Consumption of products made with khorasan wheat resulted in a significant amelioration in total cholesterol (−6.8%, low-density lipoprotein cholesterol (LDL-C (−8.1% glucose (−8% and insulin (−24.6% from baseline levels, independently of age, sex, traditional risk factors, medication and diet quality. Moreover, there was a significant reduction in reactive oxygen species (ROS, lipoperoxidation of circulating monocytes and lymphocytes, as well as in the levels of Tumor Necrosis Factor-alpha. No significant differences from baseline in the same patients were observed after the conventional control wheat intervention phase. The present results suggest that a

  5. A randomised controlled trial of complete denture impression materials.

    Science.gov (United States)

    Hyde, T P; Craddock, H L; Gray, J C; Pavitt, S H; Hulme, C; Godfrey, M; Fernandez, C; Navarro-Coy, N; Dillon, S; Wright, J; Brown, S; Dukanovic, G; Brunton, P A

    2014-08-01

    There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7-67.3%, pUnilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  6. The Acute Effects of Interval-Type Exercise on Glycemic Control in Type 2 Diabetes Subjects: Importance of Interval Length. A Controlled, Counterbalanced, Crossover Study.

    Directory of Open Access Journals (Sweden)

    Ida Jakobsen

    Full Text Available Interval-type exercise is effective for improving glycemic control, but the optimal approach is unknown. The purpose of this study was to determine the importance of the interval length on changes in postprandial glycemic control following a single exercise bout. Twelve subjects with type 2 diabetes completed a cross-over study with three 1-hour interventions performed in a non-randomized but counter-balanced order: 1 Interval walking consisting of repeated cycles of 3 min slow (aiming for 54% of Peak oxygen consumption rate [VO2peak] and 3 min fast (aiming for 89% of VO2peak walking (IW3; 2 Interval walking consisting of repeated cycles of 1 min slow and 1 min fast walking (IW1 and 3 No walking (CON. The exercise interventions were matched with regards to walking speed, and VO2 and heart rate was assessed throughout all interventions. A 4-hour liquid mixed meal tolerance test commenced 30 min after each intervention, with blood samples taken regularly. IW3 and IW1 resulted in comparable mean VO2 and heart rates. Overall mean postprandial blood glucose levels were lower after IW3 compared to CON (10.3±3.0 vs. 11.1±3.3 mmol/L; P 0.05 for both. Conversely blood glucose levels at specific time points during the MMTT differed significantly following both IW3 and IW1 as compared to CON. Our findings support the previously found blood glucose lowering effect of IW3 and suggest that reducing the interval length, while keeping the walking speed and time spend on fast and slow walking constant, does not result in additional improvements.ClinicalTrials.gov NCT02257190.

  7. A cross-over trial on soy intake and serum leptin levels in women with metabolic syndrome

    Directory of Open Access Journals (Sweden)

    Leila Azadbakht

    2010-01-01

    Full Text Available Background: Soy consumption may affect serum leptin levels and exert its beneficial effects in this way. The aim of this study was to evaluate the effect of soy consumption on serum leptin levels in postmenopausal women with metabolic syndrome. Methods: In this clinical trial, 42 postmenopausal women with metabolic syndrome were included. The patients followed three kinds of diets: control diet (Dietary Approaches to Stop Hypertension= DASH, soy protein diet, or soy nut diet for eight weeks. Serum leptin level was measured by ELISA method. Results: No significant weight change were seen in patients during three phases of trial. There was no significant difference between the end values of serum leptin concentrations following these diets (Geometric mean ± SD: 16.9 ± 2.5 ng/ml at the end of control diet, 16.1 ± 1.6 ng/ml at the end of soy protein diet, and 15.9 ± 1.7 ng/ml at the end of soy nut diet. Percent difference compared to control for serum leptin levels showed that neither soy protein nor soy nut diets could significantly alter this variable (p = 0.32. Conclusions: The results of the present study showed that neither soy protein, nor soy nut could affect weight and serum leptin levels in postmenopausal women with metabolic syndrome.

  8. Influence of having breakfast on cognitive performance and mood in 13- to 20-year-old high school students: results of a crossover trial.

    Science.gov (United States)

    Widenhorn-Müller, Katharina; Hille, Katrin; Klenk, Jochen; Weiland, Ulrike

    2008-08-01

    The goal was to determine whether breakfast had effects on the cognitive performance and mood of high school students. A crossover trial was performed in boarding schools, involving 104 students between 13 and 20 years of age. The participants were randomly assigned to 2 equal-size groups on the morning of the first testing day. One half of the total sample received a standardized breakfast, whereas the other half received no breakfast. Seven days later, the treatment order was reversed. Measurements of cognitive function included standardized tests of attention and concentration, as well as tests of verbal and spatial memory. In addition, mood was rated with a self-administered questionnaire covering the dimensions of positive and negative affect, information uptake, arousal, and alertness. Statistical analysis consisted of repeated-measures analysis of variance. Breakfast had no effect on sustained attention among high school students. Visuospatial memory was improved in male students. Self-reported alertness improved significantly in the entire study population. Male students reported feeling more positive after consuming breakfast, compared with the fasting condition. This crossover trial demonstrated positive short-term effects of breakfast on cognitive functioning and self-reported alertness in high school students.

  9. 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.

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

    Science.gov (United States)

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

    2014-09-01

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

  11. Investigations of botanicals on food intake, satiety, weight loss and oxidative stress: study protocol of a double-blind, placebo-controlled, crossover study.

    Science.gov (United States)

    Anton, Stephen D; Shuster, Jonathan; Leeuwenburgh, Christiaan

    2011-11-01

    Botanicals represent an important and underexplored source of potential new therapies that may facilitate caloric restriction and thereby may produce long-term weight loss. In particular, one promising botanical that may reduce food intake and body weight by affecting neuroendocrine pathways related to satiety is hydroxycitric acid (HCA) derived from Garcinia cambogia Desr. The objective of this article is to describe the protocol of a clinical trial designed to directly test the effects of Garcinia cambogia-derived HCA on food intake, satiety, weight loss and oxidative stress levels, and to serve as a model for similar trials. A total of 48 healthy, overweight or obese individuals (with a body mass index range of 25.0 to 39.9 kg/m(2)) between the ages of 50 to 70 will participate in this double-blind, placebo-controlled, crossover study designed to examine the effects of two doses of Garcinia cambogia-derived HCA on food intake, satiety, weight loss, and oxidative stress levels. Food intake represents the primary outcome measure and is calculated based on the total calories consumed at breakfast, lunch, and dinner meals during each test meal day. This study can be completed with far fewer subjects than a parallel design. Of the numerous botanical compounds, the compound Garcinia cambogia-derived HCA is selected for testing in the present study because of its potential to safely reduce food intake, body weight, and oxidative stress levels. We will review potential mechanisms of action and safety parameters throughout this clinical trial. ClinicalTrials.gov (Identifier: NCT01238887).

  12. Investigating the Impact of Hearing Aid Use and Auditory Training on Cognition, Depressive Symptoms, and Social Interaction in Adults With Hearing Loss: Protocol for a Crossover Trial

    Science.gov (United States)

    Meyer, Denny; Blamey, Peter J; Pipingas, Andrew; Bhar, Sunil

    2018-01-01

    Background Sensorineural hearing loss is the most common sensory deficit among older adults. Some of the psychosocial consequences of this condition include difficulty in understanding speech, depression, and social isolation. Studies have shown that older adults with hearing loss show some age-related cognitive decline. Hearing aids have been proven as successful interventions to alleviate sensorineural hearing loss. In addition to hearing aid use, the positive effects of auditory training—formal listening activities designed to optimize speech perception—are now being documented among adults with hearing loss who use hearing aids, especially new hearing aid users. Auditory training has also been shown to produce prolonged cognitive performance improvements. However, there is still little evidence to support the benefits of simultaneous hearing aid use and individualized face-to-face auditory training on cognitive performance in adults with hearing loss. Objective This study will investigate whether using hearing aids for the first time will improve the impact of individualized face-to-face auditory training on cognition, depression, and social interaction for adults with sensorineural hearing loss. The rationale for this study is based on the hypothesis that, in adults with sensorineural hearing loss, using hearing aids for the first time in combination with individualized face-to-face auditory training will be more effective for improving cognition, depressive symptoms, and social interaction rather than auditory training on its own. Methods This is a crossover trial targeting 40 men and women between 50 and 90 years of age with either mild or moderate symmetric sensorineural hearing loss. Consented, willing participants will be recruited from either an independent living accommodation or via a community database to undergo a 6-month intensive face-to-face auditory training program (active control). Participants will be assigned in random order to receive

  13. Study protocol and rationale for a randomized double-blinded crossover trial of phentermine-topiramate ER versus placebo to treat binge eating disorder and bulimia nervosa.

    Science.gov (United States)

    Dalai, Shebani Sethi; Adler, Sarah; Najarian, Thomas; Safer, Debra Lynn

    2018-01-01

    Bulimia nervosa (BN) and binge eating disorder (BED) are associated with severe psychological and medical consequences. Current therapies are limited, leaving up to 50% of patients symptomatic despite treatment, underscoring the need for additional treatment options. Qsymia, an FDA-approved medication for obesity, combines phentermine and topiramate ER. Topiramate has demonstrated efficacy for both BED and BN, but limited tolerability. Phentermine is FDA-approved for weight loss. A rationale for combined phentermine/topiramate for BED and BN is improved tolerability and efficacy. While a prior case series exploring Qsymia for BED showed promise, randomized studies are needed to evaluate Qsymia's safety and efficacy when re-purposed in eating disorders. We present a study protocol for a Phase I/IIa single-center, prospective, double-blinded, randomized, crossover trial examining safety and preliminary efficacy of Qsymia for BED and BN. Adults with BED (n=15) or BN (n=15) are randomized 1:1 to receive 12weeks Qsymia (phentermine/topiramate ER, 3.75mg/23mg-15mg/92mg) or placebo, followed by 2-weeks washout and 12-weeks crossover, where those on Qsymia receive placebo and vice versa. Subsequently participants receive 8weeks follow-up off study medications. The primary outcome is the number of binge days/week measured by EDE. Secondary outcomes include average number of binge episodes, percentage abstinence from binge eating, and changes in weight/vitals, eating psychopathology, and mood. To our knowledge this is the first randomized, double-blind protocol investigating the safety and efficacy of phentermine/topiramate in BED and BN. We highlight the background and rationale for this study, including the advantages of a crossover design. Clinicaltrials.gov identifier NCT02553824 registered on 9/17/2015. https://clinicaltrials.gov/ct2/show/NCT02553824. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Comparison of myocardial Perfusion imaging by thallium-201 single-photon emission computed tomography with SUNY4001 (adenosine) and exercise. Crossover clinical trial at multi-center

    International Nuclear Information System (INIS)

    Nishimura, Shigeyuki; Nishimura, Tsunehiko; Yamazaki, Junichi

    2004-01-01

    We compared the ischemic diagnosis ability and adverse events of 201 Tl myocardial perfusion imaging with SUNY4001 (adenosine) stress to that with exercise (ergometer) stress both on random crossover trial. Thirty one known or suspected chronic stable angina patients who are able to exercise and 10 healthy volunteers were enrolled for the trial. The early and delayed images were obtained by SPECT imaging. The concordance of diagnoses [ischemia vs. no ischemia] between the two types of stresses was 97.3% (36/37) [Kappa: 0.9068]. The sensitivity and specificity based on the exercise test were 100% (6/6) and 96.8% (30/31) respectively. The incidence of adverse events caused by SUNY4001 and the exercise were 44.7% (17/38) and 52.6% (20/38), respectively. Major adverse events caused by SUNY4001 were blood pressure (BP) decrease, flushing and headache. And those by exercise were ST decrease, dyspnea and chest pain. None of the adverse events required the intervention or caused life-threatening complication in the trial. The trial showed that the ischemic diagnosis ability and safety of 201 Tl scintigraphy with SUNY4001 stress are almost equal to those of the exercise stress that is considered as the standard stress method. We concluded that 201 Tl imaging with SUNY4001 is safe and useful for detecting ischemic heart disease, especially for patients unable to exercise adequately. (author)

  15. Does granisetron eliminate the gag reflex? A crossover, double-blind, placebo-controlled pilot study.

    Science.gov (United States)

    Barenboim, Silvina Friedlander; Dvoyris, Vladislav; Kaufman, Eliezer

    2009-01-01

    Although gagging is a frequent problem that, when severe, can jeopardize the dental procedure, no single protocol is used to alleviate this phenomenon. Selective 5-HT3 antagonists, such as granisetron, may attenuate gagging. In this study, granisetron and placebo were administered intravenously, in a crossover, double-blind manner, to 25 healthy volunteers in 2 different sessions. Gagging levels were recorded before and after administration, as were BP, pulse, and O2 saturation. Recorded results were analyzed with the use of tests for nonparametric values (P = .05). A significant increase in the depth of swab insertion was noted after administration of both placebo and drug. The increase in drug effectiveness correlated with decreased body weight. The true efficacy of granisetron in gagger patients with this treatment protocol has yet to be fully established, although it has been theorized that an increased dosage of granisetron may have a better effect.

  16. Notes on testing equality and interval estimation in Poisson frequency data under a three-treatment three-period crossover trial.

    Science.gov (United States)

    Lui, Kung-Jong; Chang, Kuang-Chao

    2016-10-01

    When the frequency of event occurrences follows a Poisson distribution, we develop procedures for testing equality of treatments and interval estimators for the ratio of mean frequencies between treatments under a three-treatment three-period crossover design. Using Monte Carlo simulations, we evaluate the performance of these test procedures and interval estimators in various situations. We note that all test procedures developed here can perform well with respect to Type I error even when the number of patients per group is moderate. We further note that the two weighted-least-squares (WLS) test procedures derived here are generally preferable to the other two commonly used test procedures in the contingency table analysis. We also demonstrate that both interval estimators based on the WLS method and interval estimators based on Mantel-Haenszel (MH) approach can perform well, and are essentially of equal precision with respect to the average length. We use a double-blind randomized three-treatment three-period crossover trial comparing salbutamol and salmeterol with a placebo with respect to the number of exacerbations of asthma to illustrate the use of these test procedures and estimators. © The Author(s) 2014.

  17. A Randomised Controlled Trial of complete denture impression materials

    Science.gov (United States)

    Hyde, T.P.; Craddock, H.L.; Gray, J.C.; Pavitt, S.H.; Hulme, C.; Godfrey, M.; Fernandez, C.; Navarro-Coy, N.; Dillon, S.; Wright, J.; Brown, S.; Dukanovic, G.; Brunton, P.A.

    2014-01-01

    Objectives There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Methods Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Results Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7–67.3%, p alginate as their material of choice for secondary impressions for complete dentures. Trial Registration: ISRCTN 01528038.

 This article forms part of a project for which the author (TPH) won the Senior Clinical Unilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. PMID:24995473

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

    Science.gov (United States)

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

    2017-10-01

    Short-term fasting can alter drug exposure but it is unknown whether this is an effect of altered oral bioavailability and/or systemic clearance. Therefore, the aim of our study was to assess the effect of short-term fasting on oral bioavailability and systemic clearance of different drugs. In a randomized, controlled, crossover trial, 12 healthy subjects received a single administration of a cytochrome P450 (CYP) probe cocktail, consisting of caffeine (CYP1A2), metoprolol (CYP2D6), midazolam (CYP3A4), omeprazole (CYP2C19) and warfarin (CYP2C9), on four occasions: an oral (1) and intravenous (2) administration after an overnight fast (control) and an oral (3) and intravenous (4) administration after 36 h of fasting. Pharmacokinetic parameters of the probe drugs were analyzed using the nonlinear mixed-effects modeling software NONMEM. Short-term fasting increased systemic caffeine clearance by 17% (p = 0.04) and metoprolol clearance by 13% (p < 0.01), whereas S-warfarin clearance decreased by 19% (p < 0.01). Fasting did not affect bioavailability. The study demonstrates that short-term fasting alters CYP-mediated drug metabolism in a non-uniform pattern without affecting oral bioavailability.

  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 are very limited data regarding the effects of blueberry flavonoid intake on vascular function in healthy humans. We investigated the impact of blueberry flavonoid intake on endothelial function in healthy men and assessed potential mechanisms of action by the assessment of circulating metabolites and neutrophil NADPH oxidase activity. Two randomized, controlled, double-blind, crossover human-intervention trials were conducted with 21 healthy men. Initially, the impact of blueberry flavonoid intake on flow-mediated dilation (FMD) and polyphenol absorption and metabolism was assessed at baseline and 1, 2, 4, and 6 h after consumption of blueberry containing 766, 1278, and 1791 mg total blueberry polyphenols or a macronutrient- and micronutrient-matched control drink (0 mg total blueberry polyphenols). Second, an intake-dependence study was conducted (from baseline to 1 h) with 319, 637, 766, 1278, and 1791 mg total blueberry polyphenols and a control. We observed a biphasic time-dependent increase in FMD, with significant increases at 1-2 and 6 h after consumption of blueberry polyphenols. No significant intake-dependence was observed between 766 and 1791 mg. However, at 1 h after consumption, FMD increased dose dependently to ≤766 mg total blueberry polyphenol intake, after which FMD plateaued. Increases in FMD were closely linked to increases in circulating metabolites and by decreases in neutrophil NADPH oxidase activity at 1-2 and 6 h. Blueberry intake acutely improves vascular function in healthy men in a time- and intake-dependent manner. These benefits may be mechanistically linked to the actions of circulating phenolic metabolites on neutrophil NADPH oxidase activity. This trial was registered at clinicaltrials.gov as NCT01292954 and NCT01829542.

  20. The Association Between Urban Tree Cover and Gun Assault: A Case-Control and Case-Crossover Study.

    Science.gov (United States)

    Kondo, Michelle C; South, Eugenia C; Branas, Charles C; Richmond, Therese S; Wiebe, Douglas J

    2017-08-01

    Green space and vegetation may play a protective role against urban violence. We investigated whether being near urban tree cover during outdoor activities was related to being assaulted with a gun. We conducted geographic information systems-assisted interviews with boys and men aged 10-24 years in Philadelphia, Pennsylvania, including 135 patients who had been shot with a firearm and 274 community controls, during 2008-2011. Each subject reported a step-by-step mapped account of where and with whom they traveled over a full day from waking until being assaulted or going to bed. Geocoded path points were overlaid on mapped layers representing tree locations and place-specific characteristics. Conditional logistic regressions were used to compare case subjects versus controls (case-control) and case subjects at the time of injury versus times earlier that day (case-crossover). When comparing cases at the time of assault to controls matched at the same time of day, being under tree cover was inversely associated with gunshot assault (odds ratio (OR) = 0.70, 95% confidence interval (CI): 0.55, 0.88), especially in low-income areas (OR = 0.69, 95% CI: 0.54, 0.87). Case-crossover models confirmed this inverse association overall (OR = 0.55, 95% CI: 0.34, 0.89) and in low-income areas (OR = 0.54, 95% CI: 0.33, 0.88). Urban greening and tree cover may hold promise as proactive strategies to decrease urban violence. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health 2017. This work is written by (a) US Government employee(s) and is in the public domain in the US.

  1. Investigating the Impact of Hearing Aid Use and Auditory Training on Cognition, Depressive Symptoms, and Social Interaction in Adults With Hearing Loss: Protocol for a Crossover Trial.

    Science.gov (United States)

    Nkyekyer, Joanna; Meyer, Denny; Blamey, Peter J; Pipingas, Andrew; Bhar, Sunil

    2018-03-23

    Sensorineural hearing loss is the most common sensory deficit among older adults. Some of the psychosocial consequences of this condition include difficulty in understanding speech, depression, and social isolation. Studies have shown that older adults with hearing loss show some age-related cognitive decline. Hearing aids have been proven as successful interventions to alleviate sensorineural hearing loss. In addition to hearing aid use, the positive effects of auditory training-formal listening activities designed to optimize speech perception-are now being documented among adults with hearing loss who use hearing aids, especially new hearing aid users. Auditory training has also been shown to produce prolonged cognitive performance improvements. However, there is still little evidence to support the benefits of simultaneous hearing aid use and individualized face-to-face auditory training on cognitive performance in adults with hearing loss. This study will investigate whether using hearing aids for the first time will improve the impact of individualized face-to-face auditory training on cognition, depression, and social interaction for adults with sensorineural hearing loss. The rationale for this study is based on the hypothesis that, in adults with sensorineural hearing loss, using hearing aids for the first time in combination with individualized face-to-face auditory training will be more effective for improving cognition, depressive symptoms, and social interaction rather than auditory training on its own. This is a crossover trial targeting 40 men and women between 50 and 90 years of age with either mild or moderate symmetric sensorineural hearing loss. Consented, willing participants will be recruited from either an independent living accommodation or via a community database to undergo a 6-month intensive face-to-face auditory training program (active control). Participants will be assigned in random order to receive hearing aid (intervention) for

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

    DEFF Research Database (Denmark)

    Volkmann, H; Nørregaard, J; Jacobsen, Søren

    1997-01-01

    The objective of this study was to test the efficacy of intravenously administered S-adenosyl-L-methionine (SAMe) in patients with fibromyalgia (FM). Thirty-four out-patients with fibromyalgia symptoms received SAMe 600 mg i.v. or placebo daily for 10 days in a cross-over trial. There was no sign......The objective of this study was to test the efficacy of intravenously administered S-adenosyl-L-methionine (SAMe) in patients with fibromyalgia (FM). Thirty-four out-patients with fibromyalgia symptoms received SAMe 600 mg i.v. or placebo daily for 10 days in a cross-over trial.......17) and slight improvement only on fatigue, quality of sleep, morning stiffness, and on the Fibromyalgia Impact Questionnaire for pain. No effect could be observed on isokinetic muscle strength, Zerrsen self-assessment questionnaire, and the face scale. No effect of SAMe in patients with FM was found...

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

    DEFF Research Database (Denmark)

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

    2017-01-01

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

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

    Science.gov (United States)

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

    2018-01-01

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

  5. [Principles of controlled clinical trials].

    Science.gov (United States)

    Martini, P

    1962-01-01

    The recovery of the patient should be facilitated as the result of therapeutic research. The basic rule for every therapeutic-clinical trial mist involve a comparison of therapeutic approaches. In acute conditions, such as acute infectious diseases, infarcts, etc., comparisons should be made between two or more groups: the collective therapeutic comparison = the between patients trial. The formation of groups, to be compared one with the other can be justified only if one is reasonably sure that a pathogenic condition indeed exists. In chronic diseases, which extend essentially unchanged over a lengthy period but are nevertheless reversible, therapeutic comparisons may be made between two or more time intervals within the course of the disease in the same individual. This type of therapeutic trial rests primarily upon a (refined!) type of specious reasoning and secondarily, upon modified statistics: the individual therapeutic comparison = the within patient trial. The collective therapeutic comparison, on the one hand, and the individual therapeutic comparison on the other, overlap somewhat in scope. The immediate therapeutic effect is not always an indication of its true value, which may become evident only upon long-term treatment. The short-term trials of therapeutic regimens in an individual must, therefore, be frequently supplemented by long-term trials which can only be carried out by comparing two groups. For many clinical investigations, therefore, the joint efforts of numerous hospitals are absolutely necessary. The second basic rule of therapeutic research is the elimination of secondary causes. The difficulties introduced by these secondary considerations are far greater in therapeutic trials carried out on ambulatory patients than has been hitherto realized. In order to remove subjective secondary causes, the author demanded, in 1931, the use of hidden or illusory media (placebos, dummies) that is, unconscious causative agents. The double blind

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

    DEFF Research Database (Denmark)

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

    2005-01-01

    This study investigated the effect of caffeine on physical performance in healthy citizens aged ≥70 yr. The randomized, double-blind, placebo-controlled, crossover study was conducted in 15 men and 15 women recruited by their general practitioner. Participants abstained from caffeine for 48 h...... 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...

  7. Effects of tonabersat on migraine with aura: a randomised, double-blind, placebo-controlled crossover study

    DEFF Research Database (Denmark)

    Hauge, Anne W; Asghar, Mohammed S; Schytz, Henrik W

    2009-01-01

    BACKGROUND: Migraine with aura is thought likely to be caused by cortical spreading depression (CSD). Tonabersat inhibits CSD, and we therefore investigated whether tonabersat has a preventive effect in migraine with aura. METHODS: In this randomised, double-blind, placebo-controlled crossover......, of whom 31 were included in the statistical analysis of efficacy. Median (IQR) attacks of aura were reduced from 3.2 (1.0-5.0) per 12 weeks on placebo to 1.0 (0-3.0) on tonabersat (p=0.01), whereas the other primary outcome measure, median migraine headache days with or without aura, was not significantly...... inhibitory effect on CSD. The results support the theory that auras are caused by CSD and that this phenomenon is not involved in attacks without aura. FUNDING: Minster Pharmaceuticals; Lundbeck Foundation....

  8. Use of isosorbide dinitrate for the symptomatic treatment of patients with Chagas' disease achalasia. A double-blind, crossover trial.

    Science.gov (United States)

    Ferreira-Filho, L P; Patto, R J; Troncon, L E; Oliveira, R B

    1991-01-01

    1. A randomized, double-blind, placebo-controlled trial was carried out to determine the efficacy of isosorbide dinitrate (ISD) on dysphagia in patients with Chagasic achalasia. 2. Twenty-three patients with Chagas' disease and dysphagia entered the study and 20 (87%) completed the two 7-day treatment periods. Subjects were given either 5 mg ISD (12 patients) or placebo (11 patients) by the sublingual route for the first 7 days. On the 8th day, patients crossed over and began another 7-day period during which they received the opposite, identical-appearing tablets. 3. Scores attributed by uninformed investigators for the frequency and severity of dysphagia were significantly lower (P less than 0.05) following ISD treatment than after the placebo period or for the pretreatment condition. A significantly higher degree of improvement of dysphagia was experienced by the patients during ISD treatment than during the placebo period. Fourteen patients experienced meal-related headaches during ISD, but not placebo treatment. The extent of improvement in general well-being due to ISD was the same when the drug was given in the first or second test period. 4. Our results indicate that ISD, 5 mg by the sublingual route, is effective in alleviating dysphagia in patients with Chagasic achalasia but its usefulness is limited by the high rate of headache as a side effect.

  9. The patient general satisfaction of mandibular single-implant overdentures and conventional complete dentures: Study protocol for a randomized crossover trial.

    Science.gov (United States)

    Kanazawa, Manabu; Tanoue, Mariko; Miyayasu, Anna; Takeshita, Shin; Sato, Daisuke; Asami, Mari; Lam, Thuy Vo; Thu, Khaing Myat; Oda, Ken; Komagamine, Yuriko; Minakuchi, Shunsuke; Feine, Jocelyne

    2018-05-01

    Mandibular overdentures retained by a single implant placed in the midline of edentulous mandible have been reported to be more comfortable and function better than complete dentures. Although single-implant overdentures are still more costly than conventional complete dentures, there are a few studies which investigated whether mandibular single-implant overdentures are superior to complete dentures when patient general satisfaction is compared. The aim of this study is to assess patient general satisfaction with mandibular single-implant overdentures and complete dentures. This study is a randomized crossover trial to compare mandibular single-implant overdentures and complete dentures in edentulous individuals. Participant recruitment is ongoing at the time of this submission. Twenty-two participants will be recruited. New mandibular complete dentures will be fabricated. A single implant will be placed in the midline of the edentulous mandible. The mucosal surface of the complete denture around the implant will be relieved for 3 months. The participants will then be randomly allocated into 2 groups according to the order of the interventions; group 1 will receive single-implant overdentures first and will wear them for 2 months, followed by complete dentures for 2 months. Group 2 will receive the same treatments in a reverse order. After experiencing the 2 interventions, the participants will choose one of the mandibular prostheses, and yearly follow-up visits are planned for 5 years. The primary outcome of this trial is patient ratings of general satisfaction on 100 mm visual analog scales. Assessments of the prostheses and oral health-related quality of life will also be recorded as patient-reported outcomes. The secondary outcomes are cost and time for treatment. Masticatory efficiency and cognitive capacity will also be recorded. Furthermore, qualitative research will be performed to investigate the factors associated with success of these mandibular

  10. Effects of Capsaicin on Older Patients with Oropharyngeal Dysphagia: A Double-Blind, Placebo-Controlled, Crossover Study.

    Science.gov (United States)

    Nakato, Rui; Manabe, Noriaki; Shimizu, Sayako; Hanayama, Kozo; Shiotani, Akiko; Hata, Jiro; Haruma, Ken

    2017-01-01

    The standard of care for older patients with oropharyngeal dysphagia (OD) is poor. Stimulation of transient receptor potential vanilloid 1 might become a pharmacological strategy for these patients. This study aimed to compare the therapeutic effect of film food containing 0.75 µg of capsaicin in these patients. In a crossover, randomized trial, 49 patients with OD were provided capsaicin or identical placebo at least 7 days apart. Patients' reported symptoms during repeated swallowing, the volume, pH and substance P (SP) concentrations in saliva, and cervical esophageal wall motion evaluated by ultrasonographic tissue Doppler imaging were obtained before and after capsaicin or placebo administration. Significantly more patients with OD who took capsaicin experienced improvement in symptoms than those who took placebo. Salivary SP levels were significantly increased after capsaicin administration compared with placebo in the effective group. The duration of cervical esophageal wall opening was significantly shorter in capsaicin administration in the effective group. Furthermore, a significant negative correlation was found between the duration of cervical esophageal wall opening and salivary SP levels. Elevated salivary SP concentrations stimulated by capsaicin greatly improve the safety and efficacy of swallowing, and shorten the swallow response in older patients with OD. © 2017 S. Karger AG, Basel.

  11. Blueberry effects on dark vision and recovery after photobleaching: placebo-controlled crossover studies.

    Science.gov (United States)

    Kalt, Wilhelmina; McDonald, Jane E; Fillmore, Sherry A E; Tremblay, Francois

    2014-11-19

    Clinical evidence for anthocyanin benefits in night vision is controversial. This paper presents two human trials investigating blueberry anthocyanin effects on dark adaptation, functional night vision, and vision recovery after retinal photobleaching. One trial, S2 (n = 72), employed a 3 week intervention and a 3 week washout, two anthocyanin doses (271 and 7.11 mg cyanidin 3-glucoside equivalents (C3g eq)), and placebo. The other trial, L1 (n = 59), employed a 12 week intervention and an 8 week washout and tested one dose (346 mg C3g eq) and placebo. In both S2 and L1 neither dark adaptation nor night vision was improved by anthocyanin intake. However, in both trials anthocyanin consumption hastened the recovery of visual acuity after photobleaching. In S2 both anthocyanin doses were effective (P = 0.014), and in L1 recovery was improved at 8 weeks (P = 0.027) and 12 weeks (P = 0.030). Although photobleaching recovery was hastened by anthocyanins, it is not known whether this improvement would have an impact on everyday vision.

  12. 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.

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

    DEFF Research Database (Denmark)

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

    2008-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Gao Joseph

    2010-06-01

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

  15. 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.

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

    Science.gov (United States)

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

    2017-08-01

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

  17. The impact of dark chocolate intake on arterial elasticity in individuals with HIV/AIDS undergoing ART: a randomized, double-blind, crossover trial.

    Science.gov (United States)

    Teixeira, Andrea Mariana Nunes da Costa; Luzia, Liania Alves; de Souza, Suelen Jorge; de Almeida Petrilli, Aline; Pontilho, Patrícia de Moraes; de Souza, Jose Maria Pacheco; Segurado, Aluísio Augusto Cotrim; Efraim, Priscila; Picone, Camila de Melo; Rondo, Patrícia Helen de Carvalho

    2017-06-21

    An increase in the frequency of cardiovascular diseases has been observed in the HIV/AIDS population. Studies involving healthy subjects or subjects with other diseases have shown benefits of chocolate supplementation on endothelial function and vasodilation. We evaluate the impact of chocolate consumption on arterial elasticity in people living with human immunodeficiency virus - PLHIV. A double-blind, crossover trial including 110 PLHIV (19 to 59 years) on antiretroviral therapy - ART for at least 6 months and with a viral load of chocolate or placebo with a 15-d washout period. Each participant received one of the two sequences: A (dark chocolate, placebo chocolate); B (placebo chocolate, dark chocolate). Arterial elasticity was measured using the HDI/PulseWave™ CR-2000 CardioVascular Profiling System®. Body composition, lipid profile, C-reactive protein, and thiobarbituric acid reactive substances were also assessed. Analysis of variance (ANOVA) for repeated measures using the Stata 11.0® program was used for cross-over analysis. Most subjects were men (59.0%) and Caucasian (46.1%) and the mean age was 44.6 ± 7.1 years. The mean time since diagnosis of HIV infection was 13.7 ± 5.3 years and the mean duration of ART was 12.9 ± 4.2 years. Chocolate consumption resulted in significant alterations in the large artery elasticity index - LAEI (p = 0.049) and the mean concentration of HDL-c was higher after supplementation with dark chocolate (p = 0.045). This is the first study to evaluate the effect of chocolate on arterial elasticity in PLHIV. The results showed that dark chocolate consumption for 15 days improved the elastic properties of the LAEI in PLHIV. These findings, added to the noninvasive method used, may expand the knowledge of CVDs in this population.

  18. Effects of exercise on the desire to smoke and physiological responses to temporary smoking abstinence: a crossover trial.

    Science.gov (United States)

    Roberts, Vaughan; Gant, Nicholas; Sollers, John J; Bullen, Chris; Jiang, Yannan; Maddison, Ralph

    2015-03-01

    Exercise has been shown to attenuate cigarette cravings during temporary smoking abstinence; however, the mechanisms of action are not clearly understood. The objectives of the study were to compare the effects of three exercise intensities on desire to smoke and explore potential neurobiological mediators of desire to smoke. Following overnight abstinence, 40 participants (25 males, 18-59 years) completed three 15 min sessions of light-, moderate-, or vigorous-intensity exercise on a cycle ergometer in a randomized crossover design. Ratings of desire to smoke were self-reported pre- and post-exercise and heart rate variability was measured throughout. Saliva and blood were analyzed for cortisol and noradrenaline in a sub-sample. Exercise influenced desire to smoke (F [2, 91] = 7.94, p exercise. There were also significant time x exercise intensity interaction effects for heart rate variability and plasma noradrenaline (F [8, 72] = 2.23, p = 0.03), with a bias in noradrenaline occurring between light and vigorous conditions (adjusted mean difference [SE] = 2850 ng/ml [592], p exercise. There was no interaction of time x exercise intensity for plasma and salivary cortisol levels. These findings support the use of vigorous exercise to reduce cigarette cravings, showing potential alterations in a noradrenergic marker.

  19. Symptom-Based Treatment of Neuropathic Pain in Spinal Cord-Injured Patients: A Randomized Crossover Clinical Trial.

    Science.gov (United States)

    Min, Kyunghoon; Oh, Yoongul; Lee, Sang-Hyuk; Ryu, Ju Seok

    2016-05-01

    The objective of this study was to identify the differences in medication effect according to pain characteristics in spinal cord-injured patients. This study is a prospective, randomized, crossover study. Fifty-five patients and 66 locations of neuropathic pain were included. Pain was classified into four spontaneous characteristics and three evoked pain characteristics. Oxcarbazepine (Na channel blocker) and pregabalin (calcium channel α2-δ ligand medication) were tried. Patients were divided into two groups: evoked pain present and evoked pain absent. Overall average visual analog scale was obtained. Oxcarbazepine was significantly more effective for patients without evoked pain than in those with it for electrical, burning, and pricking pain. The effect of pregabalin was not different regarding the presence or absence of evoked pain for all pain categories, except burning pain. In patients with evoked pain, pregabalin was shown to be significantly more effective for electrical pain, allodynia, and heat hyperalgesia than oxcarbazepine. In the evoked pain absent group, oxcarbazepine showed greater improvement than pregabalin but was not significant. In summary, the phenotype of neuropathic pain was associated with the efficacy of different pharmacologic treatments. Symptom-based treatment, therefore, can lead to more efficient analgesia.

  20. Evaluation of personalised, one-to-one interaction using Montessori-type activities as a treatment of challenging behaviours in people with dementia: the study protocol of a crossover trial.

    Science.gov (United States)

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

    2010-01-24

    The agitated behaviours that accompany dementia (e.g. pacing, aggression, calling out) are stressful to both nursing home residents and their carers and are difficult to treat. Behaviours stemming from pain, major depression or psychosis benefit from treatment with analgesics, antidepressants or antipsychotics. In other cases, psychotropic medications have limited efficacy but are used very widely. Therefore, increasingly more attention has been paid to nonpharmacological interventions which are associated with fewer risks. The aim of the current study is to test if personalised one-to-one interaction activities based on Montessori principles will reduce the frequency of behavioural symptoms of dementia significantly more than a relevant control condition. We will conduct a controlled trial with randomised cross-over between conditions. Persons with moderate to severe dementia and associated behavioural problems living in aged care facilities will be included in the study. Consented, willing participants will be assigned in random order to Montessori or control blocks for two weeks then switched to the other condition. Montessori activities derive from the principles espoused by Maria Montessori and subsequent educational theorists to promote engagement in learning, namely task breakdown, guided repetition, progression in difficulty from simple to complex, and the careful matching of demands to levels of competence. The control intervention consists of conversation or reading from and looking at pictures in a newspaper to control for non-specific benefits of one-to-one interaction. Presence of target behaviour will be noted as well as level of engagement and type of affect displayed. Secondary measures also include the Cohen-Mansfield Agitation Inventory and information on time and funds spend to prepare the activities. If our results show that use of Montessori activities is effective in treating challenging behaviours in individuals with dementia, it will

  1. A randomized crossover trial to study the effect of personalized, one-to-one interaction using Montessori-based activities on agitation, affect, and engagement in nursing home residents with Dementia.

    Science.gov (United States)

    van der Ploeg, Eva S; Eppingstall, Barbara; Camp, Cameron J; Runci, Susannah J; Taffe, John; O'Connor, Daniel W

    2013-04-01

    Increasingly more attention has been paid to non-pharmacological interventions as treatment of agitated behaviors that accompany dementia. The aim of the current study is to test if personalized one-to-one interaction activities based on Montessori principles will improve agitation, affect, and engagement more than a relevant control condition. We conducted a randomized crossover trial in nine residential facilities in metropolitan Melbourne, Australia (n = 44). Personalized one-to-one activities that were delivered using Montessori principles were compared with a non-personalized activity to control for the non-specific benefits of one-to-one interaction. Participants were observed 30 minutes before, during, and after the sessions. The presence or absence of a selected physically non-aggressive behavior was noted in every minute, together with the predominant type of affect and engagement. Behavior counts fell considerably during both the Montessori and control sessions relative to beforehand. During Montessori activities, the amount of time spend actively engaged was double compared to during the control condition and participants displayed more positive affect and interest as well. Participants with no fluency in English (all from non-English speaking backgrounds) showed a significantly larger reduction in agitation during the Montessori than control sessions. Our results show that even non-personalized social contact can assist in settling agitated residents. Tailoring activities to residents' needs and capabilities elicit more positive interactions and are especially suitable for people who have lost fluency in the language spoken predominantly in their residential facility. Future studies could explore implementation by family members and volunteers to avoid demands on facilities' resources. Australian New Zealand Clinical Trials Registry - ACTRN12609000564257.

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

    Science.gov (United States)

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

    2017-08-01

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

  3. 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.

  4. Reference bias: presentation of extreme health states prior to eq-vas improves health-related quality of life scores. a randomised cross-over trial

    Directory of Open Access Journals (Sweden)

    McPhail Steven

    2010-12-01

    Full Text Available Abstract Background Clinical practice and clinical research has made a concerted effort to move beyond the use of clinical indicators alone and embrace patient focused care through the use of patient reported outcomes such as health-related quality of life. However, unless patients give consistent consideration to the health states that give meaning to measurement scales used to evaluate these constructs, longitudinal comparison of these measures may be invalid. This study aimed to investigate whether patients give consideration to a standard health state rating scale (EQ-VAS and whether consideration of good and poor health state descriptors immediately changes their self-report. Methods A randomised crossover trial was implemented amongst hospitalised older adults (n = 151. Patients were asked to consider descriptions of extremely good (Description-A and poor (Description-B health states. The EQ-VAS was administered as a self-report at baseline, after the first descriptors (A or B, then again after the remaining descriptors (B or A respectively. At baseline patients were also asked if they had considered either EQ-VAS anchors. Results Overall 106/151 (70% participants changed their self-evaluation by ≥5 points on the 100 point VAS, with a mean (SD change of +4.5 (12 points (p Conclusions Health state self-reports may not be well considered. An immediate significant shift in response can be elicited by exposure to a mere description of an extreme health state despite no actual change in underlying health state occurring. Caution should be exercised in research and clinical settings when interpreting subjective patient reported outcomes that are dependent on brief anchors for meaning. Trial Registration Australian and New Zealand Clinical Trials Registry (#ACTRN12607000606482 http://www.anzctr.org.au

  5. Metabolic responses to a traditional Mexican diet compared with a commonly consumed US diet in women of Mexican descent: a randomized crossover feeding trial.

    Science.gov (United States)

    Santiago-Torres, Margarita; Kratz, Mario; Lampe, Johanna W; Tapsoba, Jean De Dieu; Breymeyer, Kara L; Levy, Lisa; Villaseñor, Adriana; Wang, Ching-Yun; Song, Xiaoling; Neuhouser, Marian L

    2016-02-01

    Mexican immigrants are disproportionally affected by diet-related risk of metabolic dysfunction. Whether adhering to a traditional Mexican diet or adopting a US diet contributes to metabolic changes associated with future risk of type 2 diabetes and other chronic diseases has not been investigated. The purpose of this study was to test in a randomized crossover feeding trial the metabolic responses to a Mexican diet compared with a commonly consumed US diet. First- and second-generation healthy women of Mexican descent (n = 53) were randomly assigned in a crossover design to consume a Mexican or US diet for 24 d each, separated by a 28-d washout period. Diets were eucaloric and similar in macronutrient composition. The metabolic responses to diets were assessed by measuring fasting serum concentrations of glucose, insulin, insulin-like growth factor 1 (IGF-1), insulin-like growth factor binding protein 3 (IGFBP-3), adiponectin, C-reactive protein (CRP), and interleukin 6 (IL-6), as well as the homeostasis model assessment of insulin resistance (HOMA-IR) at the beginning and end of each period. Linear mixed models tested the intervention effect on the biomarkers, while adjusting for diet sequence, feeding period, baseline and washout biomarker concentrations, age, acculturation, and BMI. Compared with the US diet, the Mexican diet reduced insulin by 14% [geometric means (95% CIs): 9.3 (8.3, 10.3) compared with 8.0 (7.2, 8.9) μU/mL; P = 0.02], HOMA-IR by 15% [2.0 (1.8, 2.3) compared with 1.7 (1.6, 2.0); P = 0.02], and IGFBP-3 by 6% (mean ± SEM: 2420 ± 29 compared with 2299 ± 29 ng/mL; P diet. Compared with the commonly consumed US diet, the traditional Mexican diet modestly improved insulin sensitivity under conditions of weight stability in healthy women of Mexican descent, while having no impact on biomarkers of inflammation. This trial was registered at clinicaltrials.gov as NCT01369173. © 2016 American Society for Nutrition.

  6. Moderate alcohol consumption, adiponectin, inflammation and type 2 diabetes risk : prospective cohort studies and randomized crossover trials

    OpenAIRE

    Joosten, M.M.

    2011-01-01

    Background: Moderate alcohol consumption has been associated with a lower risk of type 2 diabetes in various populations. However, the underlying mechanisms are not entirely clear. The aims of this thesis were 1) to substantiate the evidence of the association between alcohol consumption and type 2 diabetes in observational research and 2) to examine physiological mechanisms in randomized trials with specific attention to adiponectin, inflammation and insulin sensitivity which may mediate the...

  7. Effects of night shift on the cognitive load of physicians and urinary steroid hormone profiles - a randomized crossover trial.

    Science.gov (United States)

    Osterode, Wolf; Schranz, Sandra; Jordakieva, Galateja

    2018-03-21

    Mental and physical stress is common in physicians during night shifts. Neurocognitive effects of sleep deprivation as well as alterations in hormonal and metabolic parameters have previously been described. The aim of this crossover study was to evaluate the effects of night-shift work with partial sleep deprivation on steroid hormone excretion and possible associations with mood, sleep characteristics and cognitive functions in physicians. In total, 34 physicians (mean age 42 ± 8.5 years, 76.5% male) from different departments of the General Hospital of Vienna, Austria, were randomly assigned to two conditions: a regular day shift (8 h on duty, condition 1) and a continuous day-night shift (24 h on duty, condition 2). In both conditions, physicians collected a 24 h urine sample for steroid hormone concentration analysis and further completed psychological tests, including the sleep questionnaire (SF-A), the questionnaire for mental state (MDBF) and the computer-assisted visual memory test (FVW) before and at the end of their shifts, respectively. Although mean sleep deprivation during night shift was relatively small (~1.5 h) the impairment in participants' mental state was high in all three dimensions (mood, vigilance and agitation, p ≤ 0.001). Sleep quality (SQ), feeling of being recovered after sleep and mental balance decreased (p ≤ 0.001), whereas mental exhaustion increased (p night shift (p = 0.011), however, mostly in incorrectly identified items and not in correctly identified ones (FVW). SQ and false identified items were negatively correlated, whereas SQ and time of reaction were positively associated. It is assumed that after night shift, a tendency exists to make faster wrong decisions. SQ did not influence correctly identified items in FVW. In contrast to previous investigations, we found that only excretion rates for pregnanetriol and androsterone/etiocholanolone ratios (p night shift. A considerable stimulation of the

  8. The effects of a high protein diet on indices of health and body composition--a crossover trial in resistance-trained men.

    Science.gov (United States)

    Antonio, Jose; Ellerbroek, Anya; Silver, Tobin; Vargas, Leonel; Peacock, Corey

    2016-01-01

    Eight weeks of a high protein diet (>3 g/kg/day) coupled with a periodized heavy resistance training program has been shown to positively affect body composition with no deleterious effects on health. Using a randomized, crossover design, resistance-trained male subjects underwent a 16-week intervention (i.e., two 8-week periods) in which they consumed either their normal (i.e., habitual) or a higher protein diet (>3 g/kg/day). Thus, the purpose of this study was to ascertain if significantly increasing protein intake would affect clinical markers of health (i.e., lipids, kidney function, etc.) as well as performance and body composition in young males with extensive resistance training experience. Twelve healthy resistance-trained men volunteered for this study (mean ± SD: age 25.9 ± 3.7 years; height 178.0 ± 8.5 cm; years of resistance training experience 7.6 ± 3.6) with 11 subjects completing most of the assessments. In a randomized crossover trial, subjects were tested at baseline and after two 8-week treatment periods (i.e., habitual [normal] diet and high protein diet) for body composition, measures of health (i.e., blood lipids, comprehensive metabolic panel) and performance. Each subject maintained a food diary for the 16-week treatment period (i.e., 8 weeks on their normal or habitual diet and 8 weeks on a high protein diet). Each subject provided a food diary of two weekdays and one weekend day per week. In addition, subjects kept a diary of their training regimen that was used to calculate total work performed. During the normal and high protein phase of the treatment period, subjects consumed 2.6 ± 0.8 and 3.3 ± 0.8 g/kg/day of dietary protein, respectively. The mean protein intake over the 4-month period was 2.9 ± 0.9 g/kg/day. The high protein group consumed significantly more calories and protein (p protein group. There were no differences in dietary intake between the groups for any other measure

  9. Randomised controlled trials in Scandinavian educational research

    DEFF Research Database (Denmark)

    Pontoppidan, Maiken; Keilow, Maria; Dietrichson, Jens

    2018-01-01

    of this paper is to examine the history of randomised controlled trials in Scandinavian compulsory schools (grades 0–10; pupil ages 6-15). Specifically, we investigate drivers and barriers for randomised controlled trials in educational research and the differences between the three Scandinavian countries...... crucial for the implementation of RCTs and are likely more important in smaller countries such as the Scandinavian ones. Supporting institutions have now been established in all three countries, and we believe that the use of RCTs in Scandinavian educational research is likely to continue....... or more interventions were randomly assigned to groups of students and carried out in a school setting with the primary aim of improving the academic performance of children aged 6-15 in grades 0–10 in Denmark, Norway, or Sweden. We included both conducted and ongoing trials. Publications that seemed...

  10. Effects of SuperUlam on Supporting Concentration and Mood: A Randomized, Double-Blind, Placebo-Controlled Crossover Study

    Directory of Open Access Journals (Sweden)

    Jay K Udani

    2013-01-01

    Full Text Available Background. SuperUlam is a proprietary blend of natural ingredients aimed at supporting brain health. We aimed to evaluate the effect of SuperUlam on attention and mood in healthy adults. Methods. Twenty healthy individuals aged 35–65 were enrolled in this randomized, double-blind, placebo-controlled, crossover study. Study duration was 3 weeks and consisted of 3 visits. Measurement of cognitive function included computer-based testing of reaction time, complex attention, working memory, sustained attention, and executive functioning. Mood testing was performed via the profile of mood states (POMS survey and the Chalder fatigue scale. Results. Cognitive function testing demonstrated a significant improvement from baseline in executive functioning, cognitive flexibility, reaction time, and working memory in the product group only (P<0.05. When comparing the study product to placebo, the data demonstrated a significant decrease in tension, depression, and anger (P<0.05. There was no significant difference between the product and placebo in the other measures of mood, including vigor, fatigue, confusion, and total mood disturbance. No adverse events were reported. Conclusions. Supplementation with SuperUlam is safe to consume with potential benefits to cognitive function and mood.

  11. Effects of SuperUlam on Supporting Concentration and Mood: A Randomized, Double-Blind, Placebo-Controlled Crossover Study.

    Science.gov (United States)

    Udani, Jay K

    2013-01-01

    Background. SuperUlam is a proprietary blend of natural ingredients aimed at supporting brain health. We aimed to evaluate the effect of SuperUlam on attention and mood in healthy adults. Methods. Twenty healthy individuals aged 35-65 were enrolled in this randomized, double-blind, placebo-controlled, crossover study. Study duration was 3 weeks and consisted of 3 visits. Measurement of cognitive function included computer-based testing of reaction time, complex attention, working memory, sustained attention, and executive functioning. Mood testing was performed via the profile of mood states (POMS) survey and the Chalder fatigue scale. Results. Cognitive function testing demonstrated a significant improvement from baseline in executive functioning, cognitive flexibility, reaction time, and working memory in the product group only (P < 0.05). When comparing the study product to placebo, the data demonstrated a significant decrease in tension, depression, and anger (P < 0.05). There was no significant difference between the product and placebo in the other measures of mood, including vigor, fatigue, confusion, and total mood disturbance. No adverse events were reported. Conclusions. Supplementation with SuperUlam is safe to consume with potential benefits to cognitive function and mood.

  12. Short, frequent, 5-days-per-week, in-center hemodialysis versus 3-days-per week treatment: a randomized crossover pilot trial through the Midwest Pediatric Nephrology Consortium.

    Science.gov (United States)

    Laskin, Benjamin L; Huang, Guixia; King, Eileen; Geary, Denis F; Licht, Christoph; Metlay, Joshua P; Furth, Susan L; Kimball, Tom; Mitsnefes, Mark

    2017-08-01

    No controlled trials in children with end-stage kidney disease have assessed the benefits of more frequently administered hemodialysis (HD). We conducted a multicenter, crossover pilot trial to determine if short, more frequent (5 days per week) in-center HD was feasible and associated with improvements in blood pressure compared with three conventional HD treatments per week. Because adult studies have not controlled for the weekly duration of dialysis, we fixed the total treatment time at 12 h a week of dialysis during two 3-month study periods; only frequency varied from 5 to 3 days per week between study periods. Eight children (median age 16.7 years) consented at three children's hospitals. The prespecified primary composite outcome was a sustained 10% decrease in systolic blood pressure and/or a decrease in antihypertensive medications relative to each study period's baseline. Among the six patients completing both study periods, five (83.3%) experienced the primary outcome during HD performed 5 days per week but not 3 days per week; one of the six (16.7%) achieved that outcome during 3-day but not 5-day (p = 0.22) per week HD. During 5-day HD, all patients had significantly more treatments during which their pre-HD systolic (p = 0.01) or diastolic (p = 0.01) blood pressure was 10% lower than baseline. We observed that more frequent HD sessions per week was feasible and associated with improved blood pressure control, but barriers to changing thrice-weekly standard of care include financial reimbursement and the time demands associated with more frequent treatments.

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

    Science.gov (United States)

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

    2014-11-01

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

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

    Science.gov (United States)

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

    2012-01-01

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

  15. Effect of the rate of chest compression familiarised in previous training on the depth of chest compression during metronome-guided cardiopulmonary resuscitation: a randomised crossover trial.

    Science.gov (United States)

    Bae, Jinkun; Chung, Tae Nyoung; Je, Sang Mo

    2016-02-12

    To assess how the quality of metronome-guided cardiopulmonary resuscitation (CPR) was affected by the chest compression rate familiarised by training before the performance and to determine a possible mechanism for any effect shown. Prospective crossover trial of a simulated, one-person, chest-compression-only CPR. Participants were recruited from a medical school and two paramedic schools of South Korea. 42 senior students of a medical school and two paramedic schools were enrolled but five dropped out due to physical restraints. Senior medical and paramedic students performed 1 min of metronome-guided CPR with chest compressions only at a speed of 120 compressions/min after training for chest compression with three different rates (100, 120 and 140 compressions/min). Friedman's test was used to compare average compression depths based on the different rates used during training. Average compression depths were significantly different according to the rate used in training (ptraining at a speed of 100 compressions/min and those at speeds of 120 and 140 compressions/min (both pCPR is affected by the relative difference between the rate of metronome guidance and the chest compression rate practised in previous training. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  16. 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.

  17. 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.

  18. A Comparison of Regular Consumption of Fresh Lean Pork, Beef and Chicken on Body Composition: A Randomized Cross-Over Trial

    Science.gov (United States)

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

    2014-01-01

    Pork is the most widely eaten meat in the world and recent evidence shows that diets high in pork protein, with and without energy restriction, may have favourable effects on body composition. However, it is unclear whether these effects on body composition are specific to pork or whether consumption of other high protein meat diets may have the same benefit. Therefore we aimed to compare regular consumption of pork, beef and chicken on indices of adiposity. In a nine month randomised open-labelled cross-over intervention trial, 49 overweight or obese adults were randomly assigned to consume up to 1 kg/week of pork, chicken or beef, in an otherwise unrestricted diet for three months, followed by two further three month periods consuming each of the alternative meat options. BMI and waist/hip circumference were measured and body composition was determined using dual energy x-ray absorptiometry. Dietary intake was assessed using three day weighed food diaries. Energy expenditure was estimated from activity diaries. There was no difference in BMI or any other marker of adiposity between consumption of pork, beef and chicken diets. Similarly there were no differences in energy or nutrient intakes between diets. After three months, regular consumption of lean pork meat as compared to that of beef and chicken results in similar changes in markers of adiposity of overweight and obese Australian middle-aged men and women. PMID:24534884

  19. 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.

  20. Comparison of lorazepam and zopiclone for insomnia in patients with stroke and brain injury: a randomized, crossover, double-blinded trial.

    Science.gov (United States)

    Li Pi Shan, Rodney S; Ashworth, Nigel L

    2004-06-01

    To determine if lorazepam or zopiclone is more effective in providing a restful night of sleep and to assess the effects of these medications on cognition. A randomized, double-blinded, crossover trial was performed at a tertiary care rehabilitation inpatient unit in a teaching hospital. A total of 18 brain-injured and stroke patients, aged 20-78 yrs, were administered lorazepam, 0.5-1.0 mg, orally at bedtime as needed for 7 days and zopiclone, 3.75-7.5 mg, orally at bedtime as needed for 7 days. Total sleep time and characteristics of sleep were measured. Effects on cognition were also measured using the Folstein Mini Mental Status Exam. There was no difference in average sleep duration or in subjective measures of sleep. Cognition as assessed by the Mini Mental Status Exam revealed no difference in the zopiclone arm compared with the lorazepam arm. Zopiclone is equally effective as lorazepam in the treatment of insomnia in stroke and brain-injured patients.

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

    Science.gov (United States)

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

    2017-11-01

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

  2. Lactitol, a second-generation disaccharide for treatment of chronic portal-systemic encephalopathy. A double-blind, crossover, randomized clinical trial.

    Science.gov (United States)

    Uribe, M; Toledo, H; Perez, F; Vargas, F; Gil, S; Garcia-Ramos, G; Ravelli, G P; Guevara, L

    1987-12-01

    A double-blind crossover trial was performed to test the therapeutic usefulness and safety of lactitol, a beta-galactoside sorbitol, against lactose in 18 patients with chronic portal-systemic encephalopathy (PSE). The study included four periods: two for washout and two for lactitol and lactose administration. During washout periods, which lasted two weeks each, patients were stabilized with neomycin plus milk of magnesia. Lactitol and lactose were administered during four weeks each. Ten patients were randomly assigned to receive lactose (group A) and eight patients to receive lactitol (group B) first. PSE parameters, ie, mental state, number connection test performance, asterixis and blood ammonia levels were assessed fortnightly. Electroencephalographic tracings and stool pHs were evaluated at the end of each study period. After the first administration of lactose and lactitol, no statistically significant differences in PSE parameters were found. At the same stage, a significant stool acidification (P less than 0.05) was detected. It is concluded that lactitol seems to be safe and efficacious in treating patients with chronic PSE.

  3. Benefits and challenges of using the cohort multiple randomised controlled trial design for testing an intervention for depression.

    Science.gov (United States)

    Viksveen, Petter; Relton, Clare; Nicholl, Jon

    2017-07-06

    Trials which test the effectiveness of interventions compared with the status quo frequently encounter challenges. The cohort multiple randomised controlled trial (cmRCT) design is an innovative approach to the design and conduct of pragmatic trials which seeks to address some of these challenges. In this article, we report our experiences with the first completed randomised controlled trial (RCT) using the cmRCT design. This trial-the Depression in South Yorkshire (DEPSY) trial-involved comparison of treatment as usual (TAU) with TAU plus the offer of an intervention for people with self-reported long-term moderate to severe depression. In the trial, we used an existing large population-based cohort: the Yorkshire Health Study. We discuss our experiences with recruitment, attrition, crossover, data analysis, generalisability of results, and cost. The main challenges in using the cmRCT design were the high crossover to the control group and the lower questionnaire response rate among patients who refused the offer of treatment. However, the design did help facilitate efficient and complete recruitment of the trial population as well as analysable data that were generalisable to the population of interest. Attrition rates were also smaller than those reported in other depression trials. This first completed full trial using the cmRCT design testing an intervention for self-reported depression was associated with a number of important benefits. Further research is required to compare the acceptability and cost effectiveness of standard pragmatic RCT design with the cmRCT design. ISRCTN registry: ISRCTN02484593 . Registered on 7 Jan 2013.

  4. a randomised controlled trial oftwo prostaglandin regitnens

    African Journals Online (AJOL)

    Design. A prospective randomised controlled trial. Setting. Department of Obstetrics and Gynae- ... hours after the original administration of either prostaglandin regimen. If abortion had not taken place 36 .... Tygerberg Hospital for permission to publish, and Upjohn. (Pry) Ltd for supplying the Prepidil gel used in the study. 1.

  5. Is the randomised controlled trial the best?

    African Journals Online (AJOL)

    The randomised controlled trial (RCT) is recog nised as the gold standard of research methods, particularly to test efficacy. The primary benefit of the RCT, as everyone knows, is to prevent patient selection bias. And it should also guarantee some rigour of research methodology. It is always prospective. In a nonrandomised ...

  6. [Placebo-controlled trials in schizophrenia].

    Science.gov (United States)

    Melamed, Yuval; Davidson, Michael; Bleich, Avi

    2004-03-01

    Clinical trials involving human subjects give rise to ethical and medico-legal dilemmas. Essential research of new drugs may potentially expose patients to ineffective medications or to placebo. The complexity of the problem increases when dealing with mentally ill patients, for whom, on the one hand there is no known cure for their disease, and on the other hand, it is sometimes questionable whether or not they are able to provide informed consent to participate in clinical trials. The Israel Psychiatric Association decided to develop a position paper on the subject of placebo-controlled clinical trials in schizophrenia patients. Discussion groups were established, and the available material in the professional literature was examined, with an emphasis on recent developments. The Declaration of Helsinki and its amendments were analyzed, and experts in the field were consulted. Clinical drug trials for development of new medications are essential in all fields of medicine, especially in psychiatry. The requirement for a placebo arm in pharmaceutical trials presents ethical and clinical dilemmas that are especially complicated with regard to mentally ill persons whose free choice and ability to provide informed consent may be questionable. However, we do not believe that this predicament justifies unconditional rejection of placebo use in psychiatry, when it may provide substantial benefit for some patients. Simultaneously, it is our duty to provide stringent restrictions that will enable strict supervision over the scientific, clinical and ethical aspects of the trials. We propose the following criteria for approval of pharmaceutical trials that include a placebo arm: scientific justification; clinical and ethical justification; provision of informed consent; recruitment of patients hospitalized voluntarily; prevention of harm; administration of additional potential therapeutic interventions; benefit to patients participating in the study; control and follow

  7. Treatment of chronic portal--systemic encephalopathy with vegetable and animal protein diets. A controlled crossover study.

    Science.gov (United States)

    Uribe, M; Márquez, M A; Garcia Ramos, G; Ramos-Uribe, M H; Vargas, F; Villalobos, A; Ramos, C

    1982-12-01

    A controlled crossover clinical comparison of 40-g/day and 80-g/day vegetable protein diets vs a 40-g/day meat protein diet plus neomycin-milk of magnesia (as control therapy) was performed on 10 cirrhotic patients with mild chronic portal-systemic encephalopathy. The 40-g vegetable protein diet had a high fiber volume and contained low methionine and low aromatic amino acids. The 80-g vegetable protein diet was rich in branched-chain amino acids and fiber, with a similar content of sulfur-containing amino acids as compared to the 40-g meat protein diet. Serial semiquantitative assessments were done, including mental state, asterixis, number connection tests, electroencephalograms and blood ammonia levels. No patient developed deep coma while ingesting either vegetable protein diet or neomycin-milk of magnesia plus 40-g meat protein diet. A significant improvement in the number connection test times was observed during the 40-g vegetable protein diet (P less than 0.05) and during the 80-g vegetable protein diet (P less than 0.05) as compared to their previous 40-g meat protein--neomycin periods. In addition, during the period of 80-g vegetable protein diet, the patients showed a significant improvement in their electroencephalograms (P less than 0.05). The frequency of bowel movements significantly increased (P less than 0.05) during the 80-g vegetable protein diet period. During the 40-g vegetable protein diet, two cirrhotic--diabetic patients experienced hypoglycemia. Three patients complained of the voluminous 80-g vegetable protein diet. Patients with mild portal--systemic encephalopathy may be adequately controlled with vegetable protein diets as a single therapy.

  8. 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.

  9. Diet low in advanced glycation end products increases insulin sensitivity in healthy overweight individuals: a double-blind, randomized, crossover trial.

    Science.gov (United States)

    de Courten, Barbora; de Courten, Maximilian Pj; Soldatos, Georgia; Dougherty, Sonia L; Straznicky, Nora; Schlaich, Markus; Sourris, Karly C; Chand, Vibhasha; Scheijen, Jean Ljm; Kingwell, Bronwyn A; Cooper, Mark E; Schalkwijk, Casper G; Walker, Karen Z; Forbes, Josephine M

    2016-06-01

    The consumption of advanced glycation end products (AGEs) has increased because of modern food processing and has been linked to the development of type 2 diabetes in rodents. We determined whether changing dietary AGE intake could modulate insulin sensitivity and secretion in healthy, overweight individuals. We performed a double-blind, randomized, crossover trial of diets in 20 participants [6 women and 14 men; mean ± SD body mass index (in kg/m(2)): 29.8 ± 3.7]. Isoenergetic- and macronutrient-matched diets that were high or low in AGE content were alternately consumed for 2 wk and separated by a 4-wk washout period. At the beginning and end of each dietary period, a hyperinsulinemic-euglycemic clamp and an intravenous glucose tolerance test were performed. Dietary, plasma and urinary AGEs N(€)-(carboxymethyl)lysine (CML), N(€)-(carboxyethyl)lysin (CEL), and methylglyoxal-derived hydroimadazolidine (MG-H1) were measured with the use of mass spectrometry. Participants consumed less CML, CEL, and MG-H1 during the low-AGE dietary period than during the high-AGE period (all P diets (P = 0.001). Insulin sensitivity increased by 1.3 mg · kg(-1) · min(-1) after the low-AGE diet (P = 0.004), whereas it showed a tendency to decrease by 0.8 mg · kg(-1) · min(-1) after the high-AGE diet (P = 0.086). There was no difference in body weight or insulin secretion between diets (P = NS). A diet that is low in AGEs may reduce the risk of type 2 diabetes by increasing insulin sensitivity. Hence, a restriction in dietary AGE content may be an effective strategy to decrease diabetes and cardiovascular disease risks in overweight individuals. This trial was registered at clinicaltrials.gov as NCT00422253. © 2016 American Society for Nutrition.

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

    Science.gov (United States)

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

    2018-04-23

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

  11. Crossover trial to test the acceptability of a locally produced lipid-based nutrient supplement (LNS) for children under 2 years in Cambodia: a study protocol.

    Science.gov (United States)

    Borg, Bindi; Mihrshahi, Seema; Griffin, Mark; Chamnan, Chhoun; Laillou, Arnaud; Wieringa, Frank T

    2017-09-06

    The acceptability and efficacy of existing ready-to-use supplementary and therapeutic foods has been low in Cambodia, thus limiting success in preventing and treating malnutrition among Cambodian children. In that context, UNICEF and IRD have developed a locally produced, multiple micronutrient fortified lipid-based nutrient supplement. This food is innovative, in that it uses fish instead of milk as the animal source food. Very few supplementary foods have non-milk animal source foods, and in addition they have not been widely tested. This trial will assess the novel food's acceptability to children and caregivers. This is a cluster-randomised, incomplete block, 4×4 crossover design with no blinding. It will take place in four sites in a community setting in periurban Phnom Penh. Healthy children aged 9-23 months (n=100) will eat each of four foods for 3 days at a time. The amount they consume will be measured, and at the end of each 3-day set, caregivers will assess how well their child liked the food. After 12 days, caregivers themselves will do a sensory test of the 4 foods and will rank them in terms of preference. Ethical clearance was received from the University of Queensland Medical Research Ethics Committee (2014001070) and from Cambodia's National Ethics Committee for Health Research (03/8 NECHR). ClinicalTrials.gov, identifier: LNS-CAMB-INFANTS; NCT02257437. Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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

    Science.gov (United States)

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

    2015-01-01

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

  14. Association of schizophrenia onset age and white matter integrity with treatment effect of D-cycloserine: a randomized placebo-controlled double-blind crossover study.

    Science.gov (United States)

    Takiguchi, Kazuo; Uezato, Akihito; Itasaka, Michio; Atsuta, Hidenori; Narushima, Kenji; Yamamoto, Naoki; Kurumaji, Akeo; Tomita, Makoto; Oshima, Kazunari; Shoda, Kosaku; Tamaru, Mai; Nakataki, Masahito; Okazaki, Mitsutoshi; Ishiwata, Sayuri; Ishiwata, Yasuyoshi; Yasuhara, Masato; Arima, Kunimasa; Ohmori, Tetsuro; Nishikawa, Toru

    2017-07-12

    It has been reported that drugs which promote the N-Methyl-D-aspartate-type glutamate receptor function by stimulating the glycine modulatory site in the receptor improve negative symptoms and cognitive dysfunction in schizophrenia patients being treated with antipsychotic drugs. We performed a placebo-controlled double-blind crossover study involving 41 schizophrenia patients in which D-cycloserine 50 mg/day was added-on, and the influence of the onset age and association with white matter integrity on MR diffusion tensor imaging were investigated for the first time. The patients were evaluated using the Positive and Negative Syndrome Scale (PANSS), Scale for the Assessment of Negative Symptoms (SANS), Brief Assessment of Cognition in Schizophrenia (BACS), and other scales. D-cycloserine did not improve positive or negative symptoms or cognitive dysfunction in schizophrenia. The investigation in consideration of the onset age suggests that D-cycloserine may aggravate negative symptoms of early-onset schizophrenia. The better treatment effect of D-cycloserine on BACS was observed when the white matter integrity of the sagittal stratum/ cingulum/fornix stria terminalis/genu of corpus callosum/external capsule was higher, and the better treatment effect on PANSS general psychopathology (PANSS-G) was observed when the white matter integrity of the splenium of corpus callosum was higher. In contrast, the better treatment effect of D-cycloserine on PANSS-G and SANS-IV were observed when the white matter integrity of the posterior thalamic radiation (left) was lower. It was suggested that response to D-cycloserine is influenced by the onset age and white matter integrity. UMIN Clinical Trials Registry (number UMIN000000468 ). Registered 18 August 2006.

  15. 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

  16. The Hawthorne Effect: a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    van Haselen Robbert

    2007-07-01

    Full Text Available Abstract Background The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied. Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia. Methods Participants in a dementia trial were randomised to intensive follow-up (with comprehensive assessment visits at baseline and two, four and six months post randomisation or minimal follow-up (with an abbreviated assessment at baseline and a full assessment at six months. Our primary outcomes were cognitive functioning (ADAS-Cog and participant and carer-rated quality of life (QOL-AD. Results We recruited 176 participants, mainly through general practices. The main analysis was based on Intention to treat (ITT, with available data. In the ANCOVA model with baseline score as a co-variate, follow-up group had a significant effect on outcome at six months on the ADAS-Cog score (n = 140; mean difference = -2.018; 95%CI -3.914, -0.121; p = 0.037 favouring the intensive follow-up group, and on participant-rated quality of life score (n = 142; mean difference = -1.382; 95%CI -2.642, -0.122; p = 0.032 favouring minimal follow-up group. There was no significant difference on carer quality of life. Conclusion We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia resulted in a better outcome than minimal follow-up, as measured by their cognitive functioning. Trial registration Current controlled trials: ISRCTN45577048

  17. Effect of Membrane Permeability on Cardiovascular Risk Factors and β2m Plasma Levels in Patients on Long-Term Haemodialysis: A Randomised Crossover Trial.

    Science.gov (United States)

    Chazot, Charles; Kirchgessner, Judith; Pham, Jenny; Vo-Van, Cyril; Lorriaux, Christie; Hurot, Jean-Marc; Zaoui, Eric; Grassmann, Aileen; Jean, Guillaume; Marcelli, Daniele

    2015-01-01

    Survival of haemodialysis (HD) patients is influenced by many factors. Mortality is mainly of cardiovascular (CV) origin and related to both traditional and nontraditional CV risk factors. Low plasma Beta2-microglobulin (β2m) levels are associated with improved HD patient survival. HD session times that are longer than the conventional 4 h (i.e., extended dialysis) provide better middle molecule clearance and are also associated with a survival advantage. In this crossover randomised trial, we investigated the effect of membrane flux on CV risk factors and on β2m plasma levels in patients treated with extended dialysis. Dialysis session duration was between 5 and 8 h for all patients. Patients were randomly assigned to the treatment sequences low-flux/high-flux dialysis versus high-flux/low-flux dialysis in a crossover design after a 3-month run-in period, with each phase lasting 9 months. Of the initially enrolled 168 patients, 155 patients started the study after the run-in period, 117 patients completed Phase 1, and 83 patients completed the whole study. Lp(a), homocystein, LDL cholesterol, HDL cholesterol and serum albumin were comparable in the low-flux and high-flux treatments. The average β2m level was 43.3 ± 11.1 mg/l at the end of the low-flux phase. Independent of sequence assignation, average β2m was significantly lower at the end of the high-flux phase (27.5 ± 76.0 mg/l, p < 0.0001 versus end of low-flux phase). Both phosphate and nPNA were significantly lower at the end of the high-flux phase compared to the low-flux phase (p = 0.045 and p = 0.002, respectively). Inclusion of those patients who completed Phase 1 and who dropped out of the study during Phase 2 did not significantly change the results. In conclusion, this study did not find an influence of high-flux filters on several traditional CV risk factors in a population of HD patients treated with extended dialysis. However, high-flux filters are necessary to optimise middle molecule

  18. 3D straight-stick laparoscopy versus 3D robotics for task performance in novice surgeons: a randomised crossover trial.

    Science.gov (United States)

    Shakir, Fevzi; Jan, Haider; Kent, Andrew

    2016-12-01

    The advent of three-dimensional passive stereoscopic imaging has led to the development of 3D laparoscopy. In simulation tasks, a reduction in error rate and performance time is seen with 3D compared to two-dimensional (2D) laparoscopy with both novice and expert surgeons. Robotics utilises 3D and instrument articulation through a console interface. Robotic trials have demonstrated that tasks performed in 3D produced fewer errors and quicker performance times compared with those in 2D. It was therefore perceived that the main advantage of robotic surgery was in fact 3D. Our aim was to compare 3D straight-stick laparoscopic task performance (3D) with robotic 3D (Robot), to determine whether robotic surgery confers additional benefit over and above 3D visualisation. We randomised 20 novice surgeons to perform four validated surgical tasks, either with straight-stick 3D laparoscopy followed by 3D robotic surgery or in the reverse order. The trial was conducted in two fully functional operating theatres. The primary outcome of the study was the error rate as defined for each task, and the secondary outcome was the time taken to complete each task. The participants were asked to perform the tasks as quickly and as accurately as possible. Data were analysed using SPSS version 21. The median error rate for completion of all four tasks with the robot was 2.75 and 5.25 for 3D with a P value performance time for completion of all four tasks with the robot was 157.1 and 342.5 s for 3D with a P value 3D robotic systems over 3D straight-stick laparoscopy, in terms of reduced error rate and quicker task performance time.

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

    Science.gov (United States)

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

    2012-05-01

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

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

    Science.gov (United States)

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

    2013-02-01

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

  1. Control groups in recent septic shock trials

    DEFF Research Database (Denmark)

    Pettilä, Ville; Hjortrup, Peter B; Jakob, Stephan M

    2016-01-01

    PURPOSE: The interpretation of septic shock trial data is profoundly affected by patients, control intervention, co-interventions and selected outcome measures. We evaluated the reporting of control groups in recent septic shock trials. METHODS: We searched for original articles presenting......, and mortality outcomes, and calculated a data completeness score to provide an overall view of quality of reporting. RESULTS: A total of 24 RCTs were included (mean n = 287 patients and 71 % of eligible patients were randomized). Of the 24 studies, 14 (58 %) presented baseline data on vasopressors and 58...... % the proportion of patients with elevated lactate values. Five studies (21 %) provided data to estimate the proportion of septic shock patients fulfilling the Sepsis-3 definition. The mean data completeness score was 19 out of 36 (range 8-32). Of 18 predefined control group characteristics, a mean of 8 (range 2...

  2. The effect of Neuragen PN® on Neuropathic pain: A randomized, double blind, placebo controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Li Li

    2010-05-01

    Full Text Available Abstract Background A double blind, randomized, placebo controlled study to evaluate the safety and efficacy of the naturally derived topical oil, "Neuragen PN®" for the treatment of neuropathic pain. Methods Sixty participants with plantar cutaneous (foot sole pain due to all cause peripheral neuropathy were recruited from the community. Each subject was randomly assigned to receive one of two treatments (Neuragen PN® or placebo per week in a crossover design. The primary outcome measure was acute spontaneous pain level as reported on a visual analog scale. Results There was an overall pain reduction for both treatments from pre to post application. As compared to the placebo, Neuragen PN® led to significantly (p ® reported pain reduction within 30 minutes. This reduction within 30 minutes occurred in only twenty one of sixty (35.0% subjects receiving the placebo. In a break out analysis of the diabetic only subgroup, 94% of subjects in the Neuragen PN® group achieved pain reduction within 30 minutes vs 11.0% of the placebo group. No adverse events were observed. Conclusions This randomized, placebo controlled, clinical trial with crossover design revealed that the naturally derived oil, Neuragen PN®, provided significant relief from neuropathic pain in an all cause neuropathy group. Participants with diabetes within this group experienced similar pain relief. Trial registration ISRCTN registered: ISRCTN13226601

  3. Dietary nitrate supplementation in COPD: An acute, double-blind, randomized, placebo-controlled, crossover trial.

    LENUS (Irish Health Repository)

    Kerley, Conor P

    2014-12-19

    The acute consumption of dietary nitrate has been shown to improve exercise capacity in athletes, healthy adults and subjects with peripheral vascular disease. Many COPD patients have reduced exercise capacity. We hypothesized that acute nitrate consumption might increase incremental shuttle walk test (ISWT) distance in COPD subjects.

  4. Comparison of 4 supraglotttic devices used by paramedics during simulated CPR : a randomized controlled crossover trial.

    Science.gov (United States)

    Szarpak, Łukasz; Kurowski, Andrzej; Truszewski, Zenon; Robak, Oliver; Frass, Michael

    2015-08-01

    Ensuring an open airway during cardiopulmonary resuscitation is fundamental. The aim of this study was to determine the success rate of blind intubation during simulated cardiopulmonary resuscitation by untrained personnel. Four devices were compared in a simulated resuscitation scenario: ILMA (Intavent Direct Ltd, Buckinghamshire, United Kingdom), Cobra PLA (Engineered Medical Systems Inc, Indianapolis, IN), Supraglottic Airway Laryngopharyngeal Tube (SALT) (ECOLAB, St. Paul, MN), and Air-Q (Mercury Medical, Clearwater, FL). A group of 210 paramedics intubated a manikin with continuous chest compressions. The mean times to intubation were 40.46 ± 4.64, 33.96 ± 6.23, 17.2 ± 4.63, and 49.23 ± 13.19 seconds (SALT vs ILMA, Cobra PLA, and Air-Q; P blind intubation for the devices were 86.7%, 85.7%, 100%, and 71.4% (SALT vs ILMA, Cobra PLA, and Air-Q; P blind intubation time was the SALT device. Copyright © 2015 Elsevier Inc. All rights reserved.

  5. 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

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

    Science.gov (United States)

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

    2015-06-01

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

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

    DEFF Research Database (Denmark)

    Volkmann, H; Nørregaard, J; Jacobsen, Søren

    1997-01-01

    The objective of this study was to test the efficacy of intravenously administered S-adenosyl-L-methionine (SAMe) in patients with fibromyalgia (FM). Thirty-four out-patients with fibromyalgia symptoms received SAMe 600 mg i.v. or placebo daily for 10 days in a cross-over trial. There was no sign......The objective of this study was to test the efficacy of intravenously administered S-adenosyl-L-methionine (SAMe) in patients with fibromyalgia (FM). Thirty-four out-patients with fibromyalgia symptoms received SAMe 600 mg i.v. or placebo daily for 10 days in a cross-over trial....... There was no significant difference in improvement in the primary outcome: tender point change between the two treatment groups. There was a tendency towards statistical significance in favour of SAMe on subjective perception of pain at rest (p = 0.08), pain on movement (p = 0.11), and overall well-being (p = 0.......17) and slight improvement only on fatigue, quality of sleep, morning stiffness, and on the Fibromyalgia Impact Questionnaire for pain. No effect could be observed on isokinetic muscle strength, Zerrsen self-assessment questionnaire, and the face scale. No effect of SAMe in patients with FM was found...

  8. Upper airway stabilization by osteopathic manipulation of the sphenopalatine ganglion versus sham manipulation in OSAS patients: a proof-of-concept, randomized, crossover, double-blind, controlled study.

    Science.gov (United States)

    Jacq, Olivier; Arnulf, Isabelle; Similowski, Thomas; Attali, Valérie

    2017-12-20

    Osteopathic manipulative treatment (OMT) of the sphenopalatine ganglion (SPG) is used empirically for the treatment of rhinitis and snoring and is thought to increase pharyngeal stability. This trial was designed to study the effects of this treatment on pharyngeal stability evaluated by critical closing pressure in obstructive sleep apnoea syndrome. This single-centre, randomized, crossover, double-blind study compared active manipulation and sham manipulation of the SPG. Randomization was computer-generated. Patients each received one active manipulation and one sham manipulation at an interval of 21 days and were evaluated 30 min and 48 h after each session administered by a qualified osteopath. Neither the patients, nor the investigator performing the evaluations were informed about the order of the two techniques (double-blind). The primary endpoint was the percentage of responding patients presenting increased pharyngeal stability defined by a variation of critical closing pressure (Pcrit) of at least -4 cmH 2 O at 30 min. Secondary endpoints were the variation of Pcrit in absolute values, sleepiness and snoring. Others endpoints were lacrimation (Schirmer's test), induced pain, sensations experienced during OMT. Ten patients were included and nine (57 [50; 58] years, comprising 7 men, with an apnoea-hypopnoea index of 31.0 [25.5; 33.2]/h; (values are median [quartiles])) were analysed. Seven patients were analysed for the primary endpoint and nine patients were analysed for secondary endpoints. Five patients responded after active manipulation versus no patients after sham manipulation (p = 0.0209). Active manipulation induced more intense pain (p = 0.0089), increased lacrimation (ns) and more tactile, nociceptive and gustatory sensations (13 versus 1) compared to sham manipulation. No significant difference was observed for the other endpoints. Osteopathic manipulative treatment of the SPG may improve pharyngeal stability in obstructive sleep

  9. 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.

  10. Evaluation of eLearning for the teaching of undergraduate ophthalmology at medical school: a randomised controlled crossover study.

    Science.gov (United States)

    Petrarca, Caroline A; Warner, Julia; Simpson, Andrew; Petrarca, Robert; Douiri, Abdel; Byrne, David; Jackson, Timothy L

    2018-05-25

    To compare ophthalmology teaching delivered by eLearning with traditional lectures, in terms of undergraduate performance and satisfaction. Randomised controlled crossover study at King's College London Medical School with 245 third year medical students. The ophthalmology syllabus was divided into ten topics. Five topics were randomised to be taught by traditional lectures and five by electronic learning (eLearning). For the second rotation of students the topics were crossed over, so that those topics taught by traditional lectures were taught by eLearning and vice versa. At the end of each rotation the students sat an optional online mock examination containing 100 questions (ten on each topic). Students' examination performance was compared between the two teaching methods. Student satisfaction was assessed using an online satisfaction survey. Outcome measures were the mean percentage of correct answers across all ten topics, student satisfaction and self-assessed knowledge. The mean examination score for questions taught by eLearning was 58% (95% CI, 55.7-59.6), versus 55% (95% CI 53.1-56.8) for traditional lectures (P = 0.047). Across all topics students were more satisfied with eLearning than traditional lectures, with 87% (95% CI 84.5-88.4) rating eLearning as 'excellent' or 'good' versus 65% (95% CI 62.0-67.4) for lectures (p eLearning compared to traditional lectures, with 166 (69.7%) rating eLearning 'much better' or 'better,' 61 (25.6%) 'neutral' and 11 (4.6%) 'worse' or 'much worse.' Student satisfaction and examination performance are both enhanced by ophthalmology eLearning. Similar eLearning modules may be suitable for other specialties and postgraduate learning.

  11. Imipramine and Pregabalin Combination for Painful Polyneuropathy. A Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Holbech, Jakob V; Bach, Flemming W; Finnerup, Nanna B

    2015-01-01

    Monotherapy with first-line drugs for neuropathic pain often fails to provide sufficient pain relief or has unacceptable side effects because of the need for high doses. The aim of this trial was to test whether the combination of imipramine and pregabalin in moderate doses would relieve pain more...... effectively than monotherapy with either of the drugs. This was a randomized, double-blind, placebo-controlled, crossover, multicenter trial consisting of four 5-week treatment periods in patients with painful polyneuropathy. Treatment arms were imipramine 75 mg/d vs pregabalin 300 mg/d vs combination therapy...... randomized, and 69 patients were included in the data analysis. The effect on average pain in comparison with placebo was: combination (-1.67 NRS points, P pregabalin (-0.48 NRS points, P = 0.03). The combination therapy had significantly lower pain...

  12. The PREEMPT study - evaluating smartphone-assisted n-of-1 trials in patients with chronic pain: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Barr, Colin; Marois, Maria; Sim, Ida; Schmid, Christopher H; Wilsey, Barth; Ward, Deborah; Duan, Naihua; Hays, Ron D; Selsky, Joshua; Servadio, Joseph; Schwartz, Marc; Dsouza, Clyde; Dhammi, Navjot; Holt, Zachary; Baquero, Victor; MacDonald, Scott; Jerant, Anthony; Sprinkle, Ron; Kravitz, Richard L

    2015-02-27

    Chronic pain is prevalent, costly, and clinically vexatious. Clinicians typically use a trial-and-error approach to treatment selection. Repeated crossover trials in a single patient (n-of-1 trials) may provide greater therapeutic precision. N-of-1 trials are the most direct way to estimate individual treatment effects and are useful in comparing the effectiveness and toxicity of different analgesic regimens. The goal of the PREEMPT study is to test the 'Trialist' mobile health smartphone app, which has been developed to make n-of-1 trials easier to accomplish, and to provide patients and clinicians with tools for individualizing treatments for chronic pain. A randomized controlled trial is being conducted to test the feasibility and effectiveness of the Trialist app. A total of 244 participants will be randomized to either the Trialist app intervention group (122 patients) or a usual care control group (122 patients). Patients assigned to the Trialist app will work with their clinicians to set up an n-of-1 trial comparing two pain regimens, selected from a menu of flexible options. The Trialist app provides treatment reminders and collects data entered daily by the patient on pain levels and treatment side effects. Upon completion of the n-of-1 trial, patients review results with their clinicians and develop a long-term treatment plan. The primary study outcome (comparing Trialist to usual care patients) is pain-related interference with daily functioning at 26 weeks. Trialist will allow patients and clinicians to conduct personalized n-of-1 trials. In prior studies, n-of-1 trials have been shown to encourage greater patient involvement with care, which has in turn been associated with better health outcomes. mHealth technology implemented using smartphones may offer an efficient means of facilitating n-of-1 trials so that more patients can benefit from this approach. ClinicalTrials.gov: NCT02116621 , first registered 15 April 2014.

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

    DEFF Research Database (Denmark)

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

    1988-01-01

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

  14. Genetic Algorithm with Maximum-Minimum Crossover (GA-MMC) Applied in Optimization of Radiation Pattern Control of Phased-Array Radars for Rocket Tracking Systems

    Science.gov (United States)

    Silva, Leonardo W. T.; Barros, Vitor F.; Silva, Sandro G.

    2014-01-01

    In launching operations, Rocket Tracking Systems (RTS) process the trajectory data obtained by radar sensors. In order to improve functionality and maintenance, radars can be upgraded by replacing antennas with parabolic reflectors (PRs) with phased arrays (PAs). These arrays enable the electronic control of the radiation pattern by adjusting the signal supplied to each radiating element. However, in projects of phased array radars (PARs), the modeling of the problem is subject to various combinations of excitation signals producing a complex optimization problem. In this case, it is possible to calculate the problem solutions with optimization methods such as genetic algorithms (GAs). For this, the Genetic Algorithm with Maximum-Minimum Crossover (GA-MMC) method was developed to control the radiation pattern of PAs. The GA-MMC uses a reconfigurable algorithm with multiple objectives, differentiated coding and a new crossover genetic operator. This operator has a different approach from the conventional one, because it performs the crossover of the fittest individuals with the least fit individuals in order to enhance the genetic diversity. Thus, GA-MMC was successful in more than 90% of the tests for each application, increased the fitness of the final population by more than 20% and reduced the premature convergence. PMID:25196013

  15. Acute and second-meal effects of peanuts on glycaemic response and appetite in obese women with high type 2 diabetes risk: a randomised cross-over clinical trial.

    Science.gov (United States)

    Reis, Caio E G; Ribeiro, Daniela N; Costa, Neuza M B; Bressan, Josefina; Alfenas, Rita C G; Mattes, Richard D

    2013-06-01

    Nut consumption is associated with a reduced risk of type 2 diabetes mellitus (T2DM). The aim of the present study was to assess the effects of adding peanuts (whole or peanut butter) on first (0-240 min)- and second (240-490 min)-meal glucose metabolism and selected gut satiety hormone responses, appetite ratings and food intake in obese women with high T2DM risk. A group of fifteen women participated in a randomised cross-over clinical trial in which 42·5 g of whole peanuts without skins (WP), peanut butter (PB) or no peanuts (control) were added to a 75 g available carbohydrate-matched breakfast meal. Postprandial concentrations (0-490 min) of glucose, insulin, NEFA, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), cholecystokinin (CCK), appetitive sensations and food intake were assessed after breakfast treatments and a standard lunch. Postprandial NEFA incremental AUC (IAUC) (0-240 min) and glucose IAUC (240-490 min) responses were lower for the PB breakfast compared with the control breakfast. Insulin concentrations were higher at 120 and 370 min after the PB consumption than after the control consumption. Desire-to-eat ratings were lower, while PYY, GLP-1 and CCK concentrations were higher after the PB intake compared with the control intake. WP led to similar but non-significant effects. The addition of PB to breakfast moderated postprandial glucose and NEFA concentrations, enhanced gut satiety hormone secretion and reduced the desire to eat. The greater bioaccessibility of the lipid component in PB is probably responsible for the observed incremental post-ingestive responses between the nut forms. Inclusion of PB, and probably WP, to breakfast may help to moderate glucose concentrations and appetite in obese women.

  16. Helping adolescents to better support their peers with a mental health problem: A cluster-randomised crossover trial of teen Mental Health First Aid.

    Science.gov (United States)

    Hart, Laura M; Morgan, Amy J; Rossetto, Alyssia; Kelly, Claire M; Mackinnon, Andrew; Jorm, Anthony F

    2018-02-01

    teen Mental Health First Aid (tMHFA) is a classroom-based training programme for students aged 15-18 years to improve supportive behaviours towards peers, increase mental health literacy and reduce stigma. This research evaluated tMHFA by comparing it to a matched emergency Physical First Aid (PFA) training programme. A cluster-randomised crossover trial matched four public schools in two pairs and then randomised each to first receive tMHFA or PFA for all Year 10 students. In the subsequent calendar year, the new Year 10 cohort received the opposite intervention, giving eight cohorts. Online surveys were administered at baseline and 1 week post-training, measuring quality of first aid intentions, mental health literacy, problem recognition and stigmatising beliefs, towards fictional adolescents with depression and suicidality (John) and social anxiety (Jeanie). A total of 1942 students were randomised (979 received tMHFA, 948 received PFA), 1605 (84%) analysed for the John vignette at baseline and 1116 (69% of baseline) provided post-training data. The primary outcomes, 'helpful first aid intentions' towards John/Jeanie, showed significant group-by-time interactions with medium effect sizes favouring tMHFA ( ds = 0.50-0.58). Compared to PFA, tMHFA students also reported significantly greater improvements in confidence supporting a peer ( ds = 0.22-0.37) and number of adults rated as helpful ( ds = 0.45-0.46) and greater reductions in stigmatising beliefs ( ds = 0.12-0.40) and 'harmful first aid intentions' towards John/Jeanie ( ds = 0.15-0.41). tMHFA is an effective and feasible programme for increasing supportive first aid intentions and mental health literacy in adolescents in the short term. tMHFA could be widely disseminated to positively impact on help seeking for adolescent mental illness.

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

    Science.gov (United States)

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

    2003-12-01

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

  18. 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

    Directory of Open Access Journals (Sweden)

    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. 

  19. Bystander fatigue and CPR quality by older bystanders: a randomized crossover trial comparing continuous chest compressions and 30:2 compressions to ventilations.

    Science.gov (United States)

    Liu, Shawn; Vaillancourt, Christian; Kasaboski, Ann; Taljaard, Monica

    2016-11-01

    This study sought to measure bystander fatigue and cardiopulmonary resuscitation (CPR) quality after five minutes of CPR using the continuous chest compression (CCC) versus the 30:2 chest compression to ventilation method in older lay persons, a population most likely to perform CPR on cardiac arrest victims. This randomized crossover trial took place at three tertiary care hospitals and a seniors' center. Participants were aged ≥55 years without significant physical limitations (frailty score ≤3/7). They completed two 5-minute CPR sessions (using 30:2 and CCC) on manikins; sessions were separated by a rest period. We used concealed block randomization to determine CPR method order. Metronome feedback maintained a compression rate of 100/minute. We measured heart rate (HR), mean arterial pressure (MAP), and Borg Exertion Scale. CPR quality measures included total number of compressions and number of adequate compressions (depth ≥5 cm). Sixty-three participants were enrolled: mean age 70.8 years, female 66.7%, past CPR training 60.3%. Bystander fatigue was similar between CPR methods: mean difference in HR -0.59 (95% CI -3.51-2.33), MAP 1.64 (95% CI -0.23-3.50), and Borg 0.46 (95% CI 0.07-0.84). Compared to 30:2, participants using CCC performed more chest compressions (480.0 v. 376.3, mean difference 107.7; pCPR quality decreased significantly faster when performing CCC compared to 30:2. However, performing CCC produced more adequate compressions overall with a similar level of fatigue compared to the 30:2 method.

  20. A Single-Center, Open-Label, 3-Way Crossover Trial to Determine the Pharmacokinetic and Pharmacodynamic Interaction Between Nebivolol and Valsartan in Healthy Volunteers at Steady State.

    Science.gov (United States)

    Chen, Chun Lin; Desai-Krieger, Daksha; Ortiz, Stephan; Kerolous, Majid; Wright, Harold M; Ghahramani, Parviz

    2015-01-01

    Combining different classes of antihypertensives is more effective for reducing blood pressure (BP) than increasing the dose of monotherapies. The aims of this phase I study were to investigate pharmacokinetic and pharmacodynamic interactions between nebivolol, a vasodilatory β1-selective blocker, and valsartan, an angiotensin II receptor blocker, and to assess safety and tolerability of the combination. This was a single-center, randomized, open-label, multiple-dose, 3-way crossover trial in 30 healthy adults aged 18-45 years. Participants were randomized into 1 of 6 treatment sequences (1:1:1:1:1:1) consisting of three 7-day treatment periods followed by a 7-day washout. Once-daily oral treatments comprised nebivolol (20 mg), valsartan (320 mg), and nebivolol-valsartan combination (20/320 mg). Outcomes included AUC0-τ,ss, Cmax,ss, Tmax,ss, changes in BP, pulse rate, plasma angiotensin II, plasma renin activity, 24-hour urinary aldosterone, and adverse events. Steady-state pharmacokinetic interactions were observed but deemed not clinically significant. Systolic and diastolic BP reduction was significantly greater with nebivolol-valsartan combination than with either monotherapy. The mean pulse rate associated with nebivolol and nebivolol-valsartan treatments was consistently lower than that associated with valsartan monotherapy. A sharp increase in mean day 7 plasma renin activity and plasma angiotensin II that occurred in valsartan-treated participants was significantly attenuated with concomitant nebivolol administration. Mean 24-hour urine aldosterone at day 7 was substantially decreased after combined treatment, as compared with either monotherapy. All treatments were safe and well tolerated. In conclusion, nebivolol and valsartan coadministration led to greater reductions in BP compared with either monotherapy; nebivolol and valsartan lower BP through complementary mechanisms.

  1. Residual gastric volume evaluation with ultrasonography after ingestion of carbohydrate- or carbohydrate plus glutamine-enriched beverages: a randomized, crossover clinical trial with healthy volunteers

    Directory of Open Access Journals (Sweden)

    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.

  2. The effect of short-term dimethylglycine treatment on oxygen consumption in cytochrome oxidase deficiency: a double-blind randomized crossover clinical trial.

    Science.gov (United States)

    Liet, Jean-Michel; Pelletier, Véronique; Robinson, Brian H; Laryea, Maurice D; Wendel, Udo; Morneau, Sylvain; Morin, Charles; Mitchell, Grant; Lacroix, Jacques

    2003-01-01

    To study the effectiveness of dimethylglycine (DMG) on oxygen consumption (VO(2)) in children with Saguenay-Lac-Saint-Jean cytochrome-c oxidase (SLSJ-COX) deficiency (OMIM 220111). In a crossover randomized double-blind clinical trial, 5 children with SLSJ-COX deficiency, who were stable and old enough to comply with VO(2) measurement, were treated with placebo or DMG for 3 days, and with the alternate treatment after a 2-week washout period. VO(2) was measured by indirect calorimetry before and after treatment. Dietary caloric intake was calculated for 3 days before each measurement. Mean caloric intakes per day were 1562 and 1342 kcal x m(-2) before and during placebo, 1,336 and 1,380 before and during DMG, respectively. DMG was well tolerated and, in all cases, resulted in markedly increased blood DMG levels (617 + 203 mmol x L(-1)), versus 0 to 2 mmol x L(-1) without treatment. Mean VO(2) was lower after administration of either DMG (-1 +/- 3 mL x min(-1) x m(-2)) or placebo (-6 +/- 4), but neither difference was statistically significant. There was no detectable effect of DMG treatment on blood levels of lactate, pyruvate, bicarbonate, or pH. VO(2) values of patients (range, 101-135 mL x min(-1) x m(-2)) were lower than published norms (150-160 mL x min(-1) x m(-2)). This study suggests that treatment with DMG does not substantially change VO(2) in children with SLSJ-COX deficiency.

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

    Science.gov (United States)

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

    2016-06-01

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

  4. Effect of commercial breakfast fibre cereals compared with corn flakes on postprandial blood glucose, gastric emptying and satiety in healthy subjects: a randomized blinded crossover trial

    Directory of Open Access Journals (Sweden)

    Almér Lars-Olof

    2007-09-01

    Full Text Available Abstract Background Dietary fibre food intake is related to a reduced risk of developing diabetes mellitus. However, the mechanism of this effect is still not clear. The aim of this study was to evaluate the effect of commercial fibre cereals on the rate of gastric emptying, postprandial glucose response and satiety in healthy subjects. Methods Gastric emptying rate (GER was measured by standardized real time ultrasonography. Twelve healthy subjects were assessed using a randomized crossover blinded trial. The subjects were examined after an 8 hour fast and after assessment of normal fasting blood glucose level. Satiety scores were estimated and blood glucose measurements were taken before and at 0, 20, 30, 40, 60, 80, 100 and 120 min after the end of the meal. GER was calculated as the percentage change in the antral cross-sectional area 15 and 90 min after ingestion of sour milk with corn flakes (GER1, cereal bran flakes (GER2 or wholemeal oat flakes (GER3. Results The median value was, respectively, 42% for GER1, 33 % for GER2 and 51% for GER3. The difference between the GER after ingestion of bran flakes compared to wholemeal oat flakes was statistically significant (p = 0.023. The postprandial delta blood glucose level was statistically significantly lower at 40 min (p = 0.045 and 120 min (p = 0.023 after the cereal bran flakes meal. There was no statistical significance between the areas under the curve (AUCs of the cereals as far as blood glucose and satiety were concerned. Conclusion The result of this study demonstrates that the intake of either bran flakes or wholemeal oat flakes has no effect on the total postprandial blood glucose response or satiety when compared to corn flakes. However, the study does show that the intake of cereal bran flakes slows the GER when compared to oat flakes and corn flakes, probably due to a higher fibre content. Since these products do not differ in terms of glucose response and satiety on healthy

  5. Randomised controlled trials: important but overrated?

    LENUS (Irish Health Repository)

    Boylan, J F

    2012-02-01

    Practising physicians individualise treatments, hoping to achieve optimal outcomes by tackling relevant patient variables. The randomised controlled trial (RCT) is universally accepted as the best means of comparison. Yet doctors sometimes wonder if particular patients might benefit more from treatments that fared worse in the RCT comparisons. Such clinicians may even feel ostracised by their peers for stepping outside treatments based on RCTs and guidelines. Are RCTs the only acceptable evaluations of how patient care can be assessed and delivered? In this controversy we explore the interpretation of RCT data for practising clinicians facing individualised patient choices. First, critical care anaesthetists John Boylan and Brian Kavanagh emphasise the dangers of bias and show how Bayesian approaches utilise prior probabilities to improve posterior (combined) probability estimates. Secondly, Jane Armitage, of the Clinical Trial Service Unit in Oxford, argues why RCTs remain essential and explores how the quality of randomisation can be improved through systematic reviews and by avoiding selective reporting.

  6. Effect of Sugar-Free and Regular Toothpaste on Salivary Glucose and pH among Type 2 Diabetes- A Randomized Crossover Trial.

    Science.gov (United States)

    Kapadia, Junaid; Dodamani, Arun; Baviskar, Priya; Karibasappa, G N; Pathak, Parag; Bezalwar, Abhishek

    2017-07-01

    Diabetes is one of the most prevalent diseases of mankind having general as well as oral health manifestations. Also, there is an increase of salivary glucose level in diabetic, inducing saccharolytic bacteria in saliva which can have adverse effects on oral tissue. To assess and compare the effect of sugar-free toothpaste on salivary glucose and pH among Type 2 diabetic and non-diabetic individuals. A randomized controlled-crossover study was carried out on 30 Type 2 diabetic (Group A) and 45 non-diabetic (Group B) subjects. In first half of study, subjects in Group A and Group B were intervened with sugar-free and regular toothpaste respectively. Salivary glucose and pH was assessed before and after brushing at interval of one week for a period of four weeks. In second half, toothpastes were switched over between the groups, after sufficient washout period. Salivary glucose and pH were assessed again in the same manner for both the groups. The data was subjected to paired t-test and unpaired t-test for intragroup and intergroup comparison respectively. Salivary glucose level was significantly reduced and salivary pH was increased significantly (psalivary glucose level and salivary pH level on diabetes and non-diabetes population.

  7. ASSESSMENT OF AMLODIPINE ANTIHYPERTENSIVE EFFECT HOMOGENEITY IN CONTROLLED TRIAL

    Directory of Open Access Journals (Sweden)

    V. M. Gorbunov

    2016-01-01

    Full Text Available Aim. To compare influence of amlodipine and spirapril on ambulatory blood pressure profile, including antihypertensive effect smoothness in patients with arterial hypertension (HT.Methods. 39 patients (aged 53,7±10,0 y.o. with HT were included in the open, randomized, cross-over study, 30 patients completed study. The duration of every therapies was 4 weeks, initial control period and wash-out period between therapies lasted 1 week. The initial daily dose of amlodipine was 5 mg, standard dose of spirapril (6 mg/daily was not changed during the trial. After 1-2 weeks of treatment amlodipine dose was increased up to 10 mg/daily as well as dihydrochlorothiazide was added, if necessary. Ambulatory blood pressure monitoring (ABPM was performed initially and at the end of both therapies.Results. Both drugs demonstrated good antihypertensive effect according to ABPM data. Decrease of systolic/diastolic blood pressure was 11,2±1,8/7,6±1,2 mm Hg in amlodipine therapy and 10,0±1,8/7,1±1,2 in spirapril therapy (p<0,0001. The smoothness indexes (SI were 0,65/0,45 and 0,55/0,45, respectively, differences between two therapies were not significant. However the individual analysis of the SI distribution (with SI=0,5 as a satisfactory criterion, showed that antihypertensive effect smoothness is better in amlodipine therapy than this in spirapril one.Conclusion. Amlodipine has prominent as well as smooth antihypertensive effect, that gives it advantages in the long-term antihypertensive therapy.

  8. The Effectiveness of Music in Pediatric Healthcare: A Systematic Review of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Karline Treurnicht Naylor

    2011-01-01

    Full Text Available The aim of this study was to systematically review the effectiveness of music on pediatric health-related outcomes. Five electronic databases were searched for randomized controlled/crossover trial designs published between 1984 and 2009. Eligible studies used music as a therapy or intervention, included participants 1 to 18 years, and focused on at least one health-related outcome (with the exclusion of procedural pain. Seventeen studies met the inclusion criteria. Quantitative synthesis was hampered by an inability to aggregate data arising from heterogeneity of interventions, outcomes and measurement tools. Qualitative synthesis revealed significant improvements in one or more health outcomes within four of seven trials involving children with learning and developmental disorders; two of three trials involving children experiencing stressful life events; and four of five trials involving children with acute and/or chronic physical illness. No significant effects were found for two trials involving children with mood disorders and related psychopathology. These findings offer limited qualitative evidence to support the effectiveness of music on health-related outcomes for children and adolescents with clinical diagnoses. Recommendations for establishing a consensus on research priorities and addressing methodological limitations are put forth to support the continued advancement of this popular intervention.

  9. The Effectiveness of Music in Pediatric Healthcare: A Systematic Review of Randomized Controlled Trials

    Science.gov (United States)

    Treurnicht Naylor, Karline; Kingsnorth, Shauna; Lamont, Andrea; McKeever, Patricia; Macarthur, Colin

    2011-01-01

    The aim of this study was to systematically review the effectiveness of music on pediatric health-related outcomes. Five electronic databases were searched for randomized controlled/crossover trial designs published between 1984 and 2009. Eligible studies used music as a therapy or intervention, included participants 1 to 18 years, and focused on at least one health-related outcome (with the exclusion of procedural pain). Seventeen studies met the inclusion criteria. Quantitative synthesis was hampered by an inability to aggregate data arising from heterogeneity of interventions, outcomes and measurement tools. Qualitative synthesis revealed significant improvements in one or more health outcomes within four of seven trials involving children with learning and developmental disorders; two of three trials involving children experiencing stressful life events; and four of five trials involving children with acute and/or chronic physical illness. No significant effects were found for two trials involving children with mood disorders and related psychopathology. These findings offer limited qualitative evidence to support the effectiveness of music on health-related outcomes for children and adolescents with clinical diagnoses. Recommendations for establishing a consensus on research priorities and addressing methodological limitations are put forth to support the continued advancement of this popular intervention. PMID:20976017

  10. 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.

  11. The acute effects of graded physiological strain on soccer kicking performance: a randomized, controlled cross-over study.

    Science.gov (United States)

    Radman, Ivan; Wessner, Barbara; Bachl, Norbert; Ruzic, Lana; Hackl, Markus; Prpic, Tomislav; Markovic, Goran

    2016-02-01

    The aim of the present study was to examine the acute effects of graded physiological strain on soccer kicking performance. Twenty-eight semi-professional soccer players completed both experimental and control procedure. The experimental protocol incorporated repeated shooting trials combined with a progressive discontinuous maximal shuttle-run intervention. The initial running velocity was 8 km/h and increasing for 1 km/h every 3 min until exhaustion. The control protocol comprised only eight subsequent shooting trials. The soccer-specific kicking accuracy (KA; average distance from the ball-entry point to the goal center), kicking velocity (KV), and kicking quality (KQ; kicking accuracy divided by the time elapsed from hitting the ball to the point of entry) were evaluated via reproducible and valid test over five individually determined exercise intensity zones. Compared with baseline or exercise at intensities below the second lactate threshold (LT2), physiological exertion above the LT2 (blood lactate > 4 mmol/L) resulted in meaningful decrease in KA (11-13%; p soccer kicking performance. The results suggest that high-intensity physiological exertion above the player's LT2 impairs soccer kicking performance. In contrast, light to moderate physiological stress appears to be neither harmful nor beneficial for kicking performance.

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

    Science.gov (United States)

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

    2012-05-01

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

  13. Effect of Functional Bread Rich in Potassium, γ-Aminobutyric Acid and Angiotensin-Converting Enzyme Inhibitors on Blood Pressure, Glucose Metabolism and Endothelial Function: A Double-blind Randomized Crossover Clinical Trial.

    Science.gov (United States)

    Becerra-Tomás, Nerea; Guasch-Ferré, Marta; Quilez, Joan; Merino, Jordi; Ferré, Raimon; Díaz-López, Andrés; Bulló, Mònica; Hernández-Alonso, Pablo; Palau-Galindo, Antoni; Salas-Salvadó, Jordi

    2015-11-01

    Because it has been suggested that food rich in γ-aminobutyric acid (GABA) or angiotensin-converting enzyme inhibitor (ACEI) peptides have beneficial effects on blood pressure (BP) and other cardiovascular risk factors, we tested the effects of low-sodium bread, but rich in potassium, GABA, and ACEI peptides on 24-hour BP, glucose metabolism, and endothelial function.A randomized, double-blind, crossover trial was conducted in 30 patients with pre or mild-to-moderate hypertension, comparing three 4-week nutritional interventions separated by 2-week washout periods. Patients were randomly assigned to consume 120 g/day of 1 of the 3 types of bread for each nutritional intervention: conventional wheat bread (CB), low-sodium wheat bread enriched in potassium (LSB), and low-sodium wheat bread rich in potassium, GABA, and ACEI peptides (LSB + G). For each period, 24-hour BP measurements, in vivo endothelial function, and biochemical samples were obtained.After LSB + G consumption, 24-hour ambulatory BP underwent a nonsignificant greater reduction than after the consumption of CB and LSB (0.26 mm Hg in systolic BP and -0.63 mm Hg in diastolic BP for CB; -0.71 mm Hg in systolic BP and -1.08 mm Hg in diastolic BP for LSB; and -0.75 mm Hg in systolic BP and -2.12 mm Hg in diastolic BP for LSB + G, respectively). Diastolic BP at rest decreased significantly during the LSB + G intervention, although there were no significant differences in changes between interventions. There were no significant differences between interventions in terms of changes in in vivo endothelial function, glucose metabolism, and peripheral inflammatory parameters.Compared with the consumption of CB or LSB, no greater beneficial effects on 24-hour BP, endothelial function, or glucose metabolism were demonstrated after the consumption of LSB + G in a population with pre or mild-to-moderate hypertension. Further studies are warranted to clarify the effect of GABA on BP

  14. Regular activity breaks combined with physical activity improve postprandial plasma triglyceride, nonesterified fatty acid, and insulin responses in healthy, normal weight adults: A randomized crossover trial.

    Science.gov (United States)

    Homer, Ashleigh R; Fenemor, Stephen P; Perry, Tracy L; Rehrer, Nancy J; Cameron, Claire M; Skeaff, C Murray; Peddie, Meredith C

    Compared with prolonged sitting, regular activity breaks immediately lower postprandial glucose and insulin, but not triglyceride responses. Postprandial triglycerides can be lowered by physical activity but the effect is often delayed by ∼12 to 24 hours. The objective of the study was to determine whether regular activity breaks affect postprandial triglyceride response in a delayed manner similar to physical activity. In a randomized crossover trial, 36 adults (body mass index 23.9 kg/m 2 [standard deviation 3.9]) completed four 2-day interventions: (1) prolonged sitting (SIT); (2) prolonged sitting with 30 minutes of continuous walking (60% VO 2max ), at the end of Day 1 (SIT + PA D1 ); (3) Sitting with 2 minutes of walking (60% VO 2max ) every 30 minutes (RAB); (4) A combination of the continuous walking and regular activity breaks in 2 and 3 above (RAB + PA D1 ). Postprandial plasma triglyceride, nonesterified fatty acids, glucose, and insulin responses were measured in venous blood over 5 hours on Day 2. Compared with SIT, both RAB (difference: -43.61 mg/dL·5 hours; 95% confidence interval [CI] -83.66 to -2.67; P = .035) and RAB + PA D1 (-65.86 mg/dL·5 hours; 95% CI -112.14 to -19.58; P = .005) attenuated triglyceride total area under the curve (tAUC). RAB + PA D1 produced the greatest reductions in insulin tAUC (-23%; 95% CI -12% to -31%; P glucose tAUC (P = .290). Postprandial triglyceride response is attenuated by regular activity breaks, when measured ∼24 hours after breaks begin. Combining regular activity breaks with 30 minutes of continuous walking further improves insulinemic and lipidemic responses. Copyright © 2017 National Lipid Association. Published by Elsevier Inc. All rights reserved.

  15. Sustained impact of energy-dense TV and online food advertising on children's dietary intake: a within-subject, randomised, crossover, counter-balanced trial.

    Science.gov (United States)

    Norman, Jennifer; Kelly, Bridget; McMahon, Anne-T; Boyland, Emma; Baur, Louise A; Chapman, Kathy; King, Lesley; Hughes, Clare; Bauman, Adrian

    2018-04-12

    Policies restricting children's exposure to unhealthy food marketing have been impeded by the lack of evidence showing a direct link between food advertising exposure and children's energy intake and body weight. Food advertising exposure increases children's immediate food consumption, but whether this increased intake is compensated for at later eating occasions is not known; consequently the sustained effect on diets remains unclear. We conducted a within-subject, randomised, crossover, counterbalanced study across four, six-day holiday camps in New South Wales, Australia between April 2016 and January 2017. Children (7-12 years, n = 160) were recruited via local schools, email networks and social media. Two gender- and age-balanced groups were formed for each camp (n = 20), randomised to either a multiple- or single- media condition and exposed to food and non-food advertising in an online game and/or a television cartoon. Children's food consumption (kilojoules) was measured at a snack immediately after exposure and then at lunch later in the day. Linear mixed models were conducted to examine relationships between food advertising exposure and dietary intake, taking into account gender, age and weight status. All children in the multiple-media condition ate more at a snack after exposure to food advertising compared with non-food advertising; this was not compensated for at lunch, leading to additional daily food intake of 194 kJ (95% CI 80-308, p = 0.001, d = 0.2). Exposure to multiple-media food advertising compared with a single-media source increased the effect on snack intake by a difference of 182 kJ (95% CI 46-317, p = 0.009, d = 0.4). Food advertising had an increased effect among children with heavier weight status in both media groups. Online ('advergame') advertising combined with TV advertising exerted a stronger influence on children's food consumption than TV advertising alone. The lack of compensation at lunch for

  16. Recent randomized controlled trials in otolaryngology.

    Science.gov (United States)

    Banglawala, Sarfaraz M; Lawrence, Lauren A; Franko-Tobin, Emily; Soler, Zachary M; Schlosser, Rodney J; Ioannidis, John

    2015-03-01

    To assess recent trends in the prevalence and quality of reporting of randomized controlled trials (RCTs) in 4 otolaryngology journals. Methodology and reporting analysis. Randomized controlled trials in 4 otolaryngology journals. All RCTs published from 2011 to 2013 in 4 major otolaryngology journals were examined for characteristics of study design, quality of design and reporting, and funding. Of 5279 articles published in 4 leading otolaryngology journals from 2011 to 2013, 189 (3.3%) were RCTs. The majority of RCTs were clinical studies (86%), with the largest proportion consisting of sinonasal topics (31%). Most interventions were medical (46%), followed by surgical (38%) and mixed (16%). In terms of quality, randomization method was reported in 54% of RCTs, blinding in 33%, and adverse events in 65%. Intention-to-treat analysis was used in 32%; P values were reported in 87% and confidence intervals in 10%. Research funding was most often absent or not reported (55%), followed by not-for-profit (25%). Based on review of 4 otolaryngology journals, RCTs are still a small proportion of all published studies in the field of otolaryngology. There seem to be trends toward improvement in quality of design and reporting of RCTs, although many quality features remain suboptimal. Practitioners both designing and interpreting RCTs should critically evaluate RCTs for quality. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.

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

    International Nuclear Information System (INIS)

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

    1987-01-01

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