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Sample records for comparative crossover study

  1. Transnational comparability of advanced pharmacy practice developmental frameworks: a country-level crossover mapping study.

    Science.gov (United States)

    Udoh, Arit; Bruno, Andreia; Bates, Ian; Galbraith, Kirsten

    2018-01-04

    Previous work by the International Pharmaceutical Federation Education Initiative (FIPEd) demonstrates that even though some country-specific variations occur in pharmacy practice, there exists a set of practice-related competencies that are globally applicable. This study aimed to evaluate the transnational comparability of the Royal Pharmaceutical Society Advanced Pharmacy Framework (RPS-APF, Great Britain) and the Advanced Pharmacy Practice Framework for Australia (APPF). The objective was to obtain preliminary data on the transnational applicability of the developmental competencies contained in the two frameworks. A crossover mapping study involving 42 advanced-level pharmacists from four countries was conducted. Qualitative interview (n = 17) was also carried out to explore practitioners' perception of the frameworks. The average postregistration experience of the practitioners in the crossover study was 19 years. Directly observed within-subject agreement per advanced practice competency ranged from 45% to 86%. This agreement was significant for 87% of the competencies evaluated (k ≥ 0.21; P ≤ 0.05). The lowest agreement was in the 'governance' competency (k = 0.13; P = 0.21). Wilcoxon sum rank test showed a statistically significant within-subject difference in the 'collaborative practice' cluster (P = 0.043). This was not observed in the other five advanced practice clusters. From the qualitative interviews, practitioners generally perceived the two compared advanced-level frameworks as similar in content and indicated they found the described competencies to be useful for clarifying expectations of practice and identifying skills development needs. These findings provide preliminary evidence of the comparability and transnational applicability of the advanced pharmacy practice competencies contained in the two national competency development frameworks evaluated. © 2018 Royal Pharmaceutical Society.

  2. A crossover study comparing gabapentin and fluoxetine for the treatment of vasomotor symptoms among postmenopausal women.

    Science.gov (United States)

    Rahmanian, Mojgan; Mohseni, Arash; Ghorbani, Raheb

    2015-10-01

    To compare the effectiveness of fluoxetine and gabapentin for treatment of vasomotor symptoms (VMS) after the menopause. Between March 2011 and March 2012, a randomized crossover study was performed at a center in Semnan, Iran, among postmenopausal women aged 45-57 years with hot flashes (≥2 per day for previous 4 months) for which they had received no previous treatment. Participants were divided into two groups with consecutive numbers assigned in order of recruitment. In the first treatment round (4 weeks), group A received 20mg/day fluoxetine and group B received 300 mg/day gabapentin. After a 2-week washout period, group A received gabapentin and group B received fluoxetine in a second round (4 weeks). Information about VMS was obtained with the Greene Climacteric Scale questionnaire. Participants and all investigators except one were masked to group assignment. Data for 79 participants (39 in group A, 40 in group B) were analyzed. In both treatment rounds, gabapentin caused greater reductions in the severity of hot flashes than did fluoxetine (Pfluoxetine. Iranian Registry of Clinical Trials:IRCT2014092711019N3. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

  3. Comparative palatability of two veterinary dewormers (Milpro® and Milbemax®): a blinded randomised crossover cat study

    OpenAIRE

    Bernachon, N.; McGahie, D.; Corvaisier, D.; Benizeau, E.; Crastes, N.; Chaix, G.

    2014-01-01

    Background The combination of milbemycin oxime–praziquantel is widely used against the most common tapeworms and roundworms affecting cats. New veterinary presentations of this combination have recently been approved. Objective The objective of this study was to compare the palatability of two products using this combination, Milpro® and Milbemax®. Methods In all, 20 adult cats and 20 kittens were offered each product according to a randomisation table using a blinded crossover design. Prehen...

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

    DEFF Research Database (Denmark)

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

    1998-01-01

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

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

    Science.gov (United States)

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

    2016-07-01

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

  6. [Pulmonary mechanics, oxygenation index, and alveolar ventilation in patients with two controlled ventilatory modes. A comparative crossover study].

    Science.gov (United States)

    Castañón-González, Jorge A; León-Gutiérrez, Marco Antonio; Gallegos-Pérez, Humberto; Pech-Quijano, Jorge; Martínez-Gutíerrez, Miguel; Olvera-Chávez, Alfredo

    2003-01-01

    To compare in a crossover study pulmonary mechanics, oxigenation index (PaO(2)/FiO(2)), and partial pressure of CO(2) in arterial blood (PaCO(2)) in patients with mechanical ventilation in two controlled ventilatory modes. Intensive care unit of a university affiliated hospital. Prospective crossover clinical trial. A total 114 consecutive patients were admitted to the intensive care unit (ICU) under controlled mechanical ventilation with SaO(2) >90% and FiO(2) ventilated with tidal volume (Vt) of 7 ml/kg, respiratory rate (RR) 14/min, inspiratory-expiratory ratio 1:2 (I:E), PEEP 5 cm H(2)O, and FiO(2) 0.4. After 15 min of mechanical ventilation, pulmonary mechanics, oxygenation index (OI), and PaCO(2) were measured and registered, and ventilatory mode was switched to PC mode in group I and to VC in group II, maintaining the same ventilator settings. Pulmonary mechanics, OI, and PaCO(2) were again registered after 15 min of ventilation. Peak inspiratory pressure (PIP) was higher in VC than in PC (31.5 vs 26 cm H(2)O), which resulted in a significant increase in transpulmonary pressure amplitude difference (DP) (25 vs 19 cm H(2)O). Mean airway pressure (MAP) and OI were lower in VC than in PC (11.5 vs 12 cm H(2)O, and 198.5 vs 215, respectively). Dynamic compliance (DynC) was lower in VC than in PC (20 vs 26 ml/cm H(2)O), p ventilator settings in the same patient, PC and not VC ventilation decreases PIP (which results in smaller transpulmonary pressure amplitude difference), increases MAP, and DynC and improves the oxygenation index.

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

    DEFF Research Database (Denmark)

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

    1998-01-01

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

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

    Science.gov (United States)

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

    2014-04-01

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

  9. A comparative crossover study on the treatment of hemifacial spasm and blepharospasm: preseptal and pretarsal botulinum toxin injection techniques.

    Science.gov (United States)

    Lolekha, Praween; Choolam, Arthita; Kulkantrakorn, Kongkiat

    2017-11-01

    Hemifacial spasm (HFS) and benign essential blepharospasm (BEB) are chronic and disabling abnormal craniofacial movements that produce involuntary eyelid twitching and closure. The efficacy and safety of botulinum toxin type A (BoNT-A) injections have been accepted and widely used for the treatment of HFS and BEB. However, different injection sites may influence the effectiveness, doses, and side effects. The aim of this study is to compare the efficacy, patient satisfaction, and complications of low-dose BoNT-A injections between injection at the preseptal (PS) and the pretarsal (PT) portion of the orbicularis oculi muscle. A total of 40 patients, 31 patients with HFS and 9 patients with BEB, participated in this study. Each patient received both PS and PT BoNT-A injections in a crossover design study. Latency to response, duration of improvement, the Jankovic Rating Scale (JRS), self-response scale, patient satisfaction scale, and complications were compared. Low-dose injections of BoNT-A at the PT portion produced a significantly higher response rate in terms of latency to response, duration of improvement, JRS, self-response scale, and patient satisfaction scale than the PS injections. Major side effects including ptosis and droopy eyelid were observed only after the PS injections. These findings confirmed that low-dose injections of BoNT-A at the PT portion provide more efficacy, patient satisfaction, and fewer complications than the PS injections for the treatment of involuntary eyelid twitching and closure in patients with HFS and BEB.

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

    Science.gov (United States)

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

    2015-05-01

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

  11. Comparative analysis of genetic crossover operators in knapsack ...

    African Journals Online (AJOL)

    The Genetic Algorithm (GA) is an evolutionary algorithms and technique based on natural selections of individuals called chromosomes. In this paper, a method for solving Knapsack problem via GA (Genetic Algorithm) is presented. We compared six different crossovers: Crossover single point, Crossover Two point, ...

  12. Comparative Analysis of Genetic Crossover Operators in Knapsack ...

    African Journals Online (AJOL)

    ADOWIE PERE

    ABSTRACT: The Genetic Algorithm (GA) is an evolutionary algorithms and technique based on natural selections of individuals called chromosomes. In this paper, a method for solving. Knapsack problem via GA (Genetic Algorithm) is presented. We compared six different crossovers: Crossover single point, Crossover Two ...

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

    Directory of Open Access Journals (Sweden)

    V. V. Yakusevich

    2011-01-01

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

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

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    Assawawitoontip, Surin; Wiwanitkit, Viroj

    2002-06-01

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

  15. A comparative study of candesartan versus propranolol for migraine prophylaxis: A randomised, triple-blind, placebo-controlled, double cross-over study.

    Science.gov (United States)

    Stovner, Lars J; Linde, Mattias; Gravdahl, Gøril B; Tronvik, Erling; Aamodt, Anne H; Sand, Trond; Hagen, Knut

    2014-06-01

    The objective of this article is to see whether the effect of candesartan for migraine prevention, shown in one previous study, could be confirmed in a new study, and if so, whether the effect was comparable to that of propranolol (non-inferiority analysis), and whether adverse events were different. In a randomised, triple-blind, double cross-over study, 72 adult patients with episodic or chronic migraine went through three 12-week treatment periods on either candesartan 16 mg, propranolol slow-release 160 mg, or placebo. The main outcome measures were days with migraine headache per four weeks (primary outcome), days with headache, hours with headache, proportion of responders (>50% reduction of migraine days from baseline), and adverse events. In the modified intention-to treat-analysis, candesartan and propranolol were both superior to placebo: 2.95 (95% confidence interval: 2.35-3.55%) and 2.91 (2.36-3.45%), versus 3.53 (2.98-4.08%) for migraine days per month (p = 0.02 for both comparisons, Wilcoxon's paired signed rank test, blinded statistical analysis). Candesartan was non-inferior to propranolol (and vice versa). The proportion of responders was significantly higher on candesartan (43%) and propranolol (40%) than on placebo (23%) (p = 0.025 and candesartan (n = 133%) and propranolol (n = 143%) than on placebo (n = 90%), and the adverse event profiles of the active substances differed somewhat. It is confirmed that candesartan 16 mg is effective for migraine prevention, with an effect size similar to propranolol 160 mg, and with somewhat different adverse events. EUDRACT (2008-002312-7), ClinicalTrials.gov (NCT00884663). © International Headache Society 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

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

    Science.gov (United States)

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

    2015-10-01

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

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

    Science.gov (United States)

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

    2014-01-01

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

  18. Osteotomy for lower third molar germectomy: randomized prospective crossover clinical study comparing piezosurgery and conventional rotatory osteotomy.

    Science.gov (United States)

    Sivolella, Stefano; Berengo, Mario; Bressan, Eriberto; Di Fiore, Adolfo; Stellini, Edoardo

    2011-06-01

    The aim of the present study was to compare piezoelectric surgery and conventional rotatory osteotomy for mandibular third molar germ extraction to determine the 2 methods' suitability and the postoperative outcomes. Mandibular third molar germectomy was performed bilaterally, randomly choosing 1 side for rotatory osteotomy (rotatory group) and the other for piezoelectric surgery (piezo group). The predictor variable was the duration of the surgical procedure. The outcome variables were the suitability of the method used, bleeding, and the postoperative parameters (ie, mouth opening range, clinical appearance of soft tissues, exudate, abscess, wound dehiscence, locoregional lymphadenopathy, pain on palpation at the extraction site, persistent edema) at 7 and 30 days postoperatively. The patients recorded their subjective postoperative pain daily for 7 days using a visual analog scale. The Wilcoxon rank-sum test and stepwise logistic regression model with binary variables were used for statistical analysis. A total of 26 patients (mean age 15.4 ± 1.29 years) were enrolled in the present study. The time needed to complete the osteotomy and extraction was significantly greater for the piezo group (15.77 ± 6.56 minutes) than for the rotatory group (11.77 ± 6.24 minutes; P = .028). No statistically significant differences emerged between the 2 methods for the other outcome variables considered. Piezoelectric osteotomy proved comparable to the rotatory method in terms of the surgeon's perception of the suitability of the 2 methods and the related postoperative sequelae. However, piezoelectric osteotomy took longer to complete than the rotatory method. Copyright © 2011 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  19. Comparing McGRATH® MAC, C-MAC®, and Macintosh Laryngoscopes Operated by Medical Students: A Randomized, Crossover, Manikin Study

    Directory of Open Access Journals (Sweden)

    Myungju Shin

    2016-01-01

    Full Text Available We hypothesized that the McGRATH MAC would decrease the time of intubation compared to C-MAC for novices. Thirty-nine medical students who had used the Macintosh blade to intubate a manikin fewer than 3 times were recruited. The participants performed sequential intubations on the manikin in two simulated settings that included a normal airway and a difficult airway (tongue edema. The intubation time, success rate of intubation, Cormack-Lehane grade at laryngoscopy, and difficulty using the device were recorded. Each participant was asked to identify the device that was most useful. The intubation time decreased significantly and by a similar amount to the McGRATH MAC and C-MAC compared to the Macintosh blade (P<0.001 and P=0.017, resp.. In the difficult airway, the intubation times were similar among the three devices. The McGRATH MAC and C-MAC significantly increased the success rate of intubation, improved the Cormack-Lehane grade, and decreased the difficulty score compared to the Macintosh blade in both airway settings. The majority of participants selected the McGRATH MAC as the most useful device. The McGRATH MAC and C-MAC may offer similar benefits for intubation compared to the Macintosh blade in normal and difficult airway situations.

  20. Comparing McGRATH® MAC, C-MAC®, and Macintosh Laryngoscopes Operated by Medical Students: A Randomized, Crossover, Manikin Study

    Science.gov (United States)

    Shin, Myungju; Lee, Ki-Young

    2016-01-01

    We hypothesized that the McGRATH MAC would decrease the time of intubation compared to C-MAC for novices. Thirty-nine medical students who had used the Macintosh blade to intubate a manikin fewer than 3 times were recruited. The participants performed sequential intubations on the manikin in two simulated settings that included a normal airway and a difficult airway (tongue edema). The intubation time, success rate of intubation, Cormack-Lehane grade at laryngoscopy, and difficulty using the device were recorded. Each participant was asked to identify the device that was most useful. The intubation time decreased significantly and by a similar amount to the McGRATH MAC and C-MAC compared to the Macintosh blade (P Cormack-Lehane grade, and decreased the difficulty score compared to the Macintosh blade in both airway settings. The majority of participants selected the McGRATH MAC as the most useful device. The McGRATH MAC and C-MAC may offer similar benefits for intubation compared to the Macintosh blade in normal and difficult airway situations. PMID:27703983

  1. Does macrolide use confer risk of out-of-hospital cardiac arrest compared with penicillin V? A Danish national case-crossover and case-time-control study.

    Science.gov (United States)

    Hertz, Frederik Boetius; Jensen, Aksel; Knudsen, Jenny D; Arpi, Magnus; Andersson, Charlotte; Gislason, Gunnar H; Køber, Lars; Torp-Pedersen, Christian; Lippert, Freddy; Weeke, Peter E

    2018-02-23

    Macrolides have been associated with proarrhythmic properties, but the evidence is conflicting. We evaluated the risk of out-of-hospital cardiac arrest (OHCA) associated with specific macrolides in a retrospective study. Associations between specific macrolides and OHCA were examined by conditional logistic regression analyses in case-crossover and case-time-control models, using penicillin-V treatment as the comparative reference. From nationwide registries, we identified all OHCAs in Denmark from 2001 to 2010 and use of antibiotics. The present study was approved by the Danish Data Protection Agency (Danish Data Protection Agency (ref.no. 2007-58-0015, local ref.no. GEH-2014-017, (I-Suite.nr. 02 735)). We identified 29 111 patients with an OHCA. Of these, 514 were in macrolide treatment ≤7 days before OHCA and 1237 in penicillin-V treatment. In the case-crossover analyses, overall macrolide use was not associated with OHCA with penicillin V as negative comparative reference (OR=0.90; 95% CI 0.73 to 1.10). Compared with penicillin-V treatment, specific macrolides were not associated with increased risk of OHCA: roxithromycin (OR=0.97; 95% CI 0.74 to 1.26), erythromycin (OR=0.68; 95% CI 0.44 to 1.06), clarithromycin (OR=0.95; 95% CI 0.61 to 1.48) and azithromycin (OR=0.85; 95% CI 0.57 to 1.27).Similar results were obtained using case-time-control models: overall macrolide use (OR=0.81; 95% CI 0.62 to 1.06) and specific macrolides (roxithromycin ( OR=0.70; 95% CI 0.49 to 1.00), erythromycin ( OR=0.67; 95% CI 0.38 to 1.18), clarithromycin ( OR=0.75; 95% CI 0.41 to 1.39) or azithromycin ( OR=1.17; 95% CI 0.70 to 1.95)). The risk of OHCA during treatment with macrolides was similar to that of penicillin V, suggesting no additional risk of OHCA associated with macrolides. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  2. A Prospective, Randomized, Crossover, Multicenter Study Comparing Quality of Life Using Compact versus Standard Catheters for Intermittent Self-Catheterization

    DEFF Research Database (Denmark)

    Chartier-Kastler, Emmanuel; Amarenco, Gérard; Lindbo, Lena

    2013-01-01

    Intermittent catheterization is the recommended standard treatment for neurogenic bladder dysfunction. However, standard intermittent catheters can be unwieldy, difficult to use and carry discreetly. This can influence patient ability to perform catheterization efficiently, discreetly and privately......, therefore, affecting patient quality of life. We evaluated whether the discreet design of the compact catheter would improve quality of life in intermittent catheterization users compared with standard catheters....

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

    Science.gov (United States)

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

    2013-11-01

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

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

    OpenAIRE

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

    2015-01-01

    Introduction This study was conducted according to GCP criteria as a prospective randomized cross-over study. The primary goal of the study was to determine clinical findings and patient satisfaction with postoperative treatment. 29 patients with a distal radius fracture that was surgically stabilized from volar and who met the inclusion criteria were enrolled over a 12-month period. Each patient randomly received either a dorsal plaster splint or a vacuum-fit flexible but blocked orthosis ap...

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

    NARCIS (Netherlands)

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

    1998-01-01

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

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

    Science.gov (United States)

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

    2010-01-15

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

  7. The efficacy of acetaminophen-caffeine compared to Ibuprofen in the control of postoperative pain after periodontal surgery: a crossover pilot study.

    Science.gov (United States)

    Rashwan, Weam A M

    2009-06-01

    Previous studies showed that non-steroidal anti-inflammatory drugs (NSAIDs) have significant benefits in the control of pain after periodontal surgery. Acetaminophen (centrally acting NSAID) is believed to provide less analgesic efficacy than ibuprofen (centrally and peripherally acting NSAID). This study compared an alternative combination of acetaminophen, 500 mg, with caffeine, 30 mg, to ibuprofen, 400 mg, in pain management after periodontal surgeries. A prospective, randomized, double-masked crossover clinical trial was conducted on 15 patients. Open flap debridement was performed on two quadrants with a 3-week interval in between. Each quadrant was randomly assigned to acetaminophen, 500 mg, with caffeine, 30 mg, or ibuprofen, 400 mg, immediately after surgery and 8 hours after the first dose. Postoperative pain was assessed during the first 8 hours and on the following day using the 101-point numeric rate scale (NRS-101) and the four-point verbal rating scale (VRS-4). Using the NRS-101, the acetaminophen-caffeine group showed statistically significantly lower mean pain scores than the ibuprofen group at 1 and 2 hours (P = 0.002), whereas at 6, 7, and 8 hours, the ibuprofen group showed statistically significantly lower mean pain scores (P 0.05). Acetaminophen, 500 mg, with caffeine, 30 mg, can be used efficiently in controlling postoperative pain after open flap debridement, especially in patients with gastric ulcers or bleeding tendency because acetaminophen is less hazardous than ibuprofen.

  8. A mobile application improves therapy-adherence rates in elderly patients undergoing rehabilitation: A crossover design study comparing documentation via iPad with paper-based control.

    Science.gov (United States)

    Mertens, Alexander; Brandl, Christopher; Miron-Shatz, Talya; Schlick, Christopher; Neumann, Till; Kribben, Andreas; Meister, Sven; Diamantidis, Clarissa Jonas; Albrecht, Urs-Vito; Horn, Peter; Becker, Stefan

    2016-09-01

    Medication adherence is crucial for success in the management of patients with chronic conditions. This study analyzes whether a mobile application on a tablet aimed at supporting drug intake and vital sign parameter documentation affects adherence in elderly patients.Patients with coronary heart disease and no prior knowledge of tablet computers were recruited. They received a personal introduction to the mobile application Medication Plan, installed on an Apple iPad. The study was conducted using a crossover design with 3 sequences: initial phase, interventional phase (28 days of using the app system), and comparative phase (28 days of using a paper diary). Users experienced the interventional and comparative phases alternately.A total of 24 patients (12 males; mean age 73.8 years) were enrolled in the study. The mean for subjectively assessed adherence (A14-scale; 5-point Likert scale, from "never" to "very often" which results in a score from 0 to 56) before the study was 50.0 (SD = 3.44). After both interventions there was a significant increase, which was more pronounced after the interventional phase (54.0; SD = 2.01) than after the comparative phase (52.6; SD = 2.49) (for all pairs after both interventions, P mobile app for medication adherence increased objectively and subjectively measured adherence in elderly users undergoing rehabilitation. The findings have promising clinical implications: digital tools can assist chronic disease patients achieve adherence to medication and to blood pressure measurement. Although this requires initial offline training, it can reduce complications and clinical overload because of nonadherence.

  9. Remifentanil-propofol analgo-sedation shortens duration of ventilation and length of ICU stay compared to a conventional regimen: A centre randomised, cross-over, open-label study in the Netherlands

    NARCIS (Netherlands)

    F.W. Rozendaal (Frans); P.E. Spronk (Peter); F.F. Snellen (Ferdinand); A. Schoen (Adri); A.R.H. van Zanten (Arthur); N.A. Foudraine (Norbert); P.G.H. Mulder (Paul); J. Bakker (Jan)

    2009-01-01

    textabstractObjective: Compare duration of mechanical ventilation (MV), weaning time, ICU-LOS (ICU-LOS), efficacy and safety of remifentanil-based regimen with conventional sedation and analgesia. Design: Centre randomised, open-label, crossover, 'real-life' study. Setting: 15 Dutch hospitals.

  10. Fructose acute effects on glucose, insulin, and triglyceride after a solid meal compared with sucralose and sucrose in a randomized crossover study.

    Science.gov (United States)

    Gallagher, Clare; Keogh, Jennifer B; Pedersen, Eva; Clifton, Peter M

    2016-06-01

    Fructose, which is a sweetener with a low glycemic index, has been shown to elevate postprandial triglyceride compared with glucose. There are limited data on the effect of fructose in a solid mixed meal containing starch and protein. We determined the effects of sucrose, fructose, and sucralose on triglyceride, glucose, and insulin in an acute study in healthy, overweight, and obese individuals. The study had a randomized crossover design. Twenty-seven participants with a mean age of 44 y and a mean body mass index (in kg/m(2)) of 26 completed the study. Fructose (52 g), sucrose (65 g), and sucralose (0.1 g) were delivered as sweet-taste-balanced muffins with a total fat load (66 g). Blood samples were taken at baseline and every 30 min for 4-h glucose, triglyceride, and insulin concentrations, and the area under the curve (AUC) and the incremental area under the curve (iAUC) were analyzed. No significant difference was shown between the 3 sweeteners for triglyceride and glucose concentrations and the AUC. The glucose iAUC was lower for fructose than for sucrose and sucralose (P sucralose (P-treatment = 0.041). Fructose, at a moderate dose, did not significantly elevate triglyceride compared with sucrose or sucralose and lowered the glucose iAUC. These results indicate that these sweeteners, at an equivalent sweetness, can be used in normal solid meals. Fructose showed a lower insulin response, which may be beneficial in the long term in individuals at risk of type 2 diabetes. This trial was registered at the Australian New Zealand Clinical Trials Registry as ACTRN12615000279527. © 2016 American Society for Nutrition.

  11. Analyses adjusting for selective crossover show improved overall survival with adjuvant letrozole compared with tamoxifen in the BIG 1-98 study.

    Science.gov (United States)

    Colleoni, Marco; Giobbie-Hurder, Anita; Regan, Meredith M; Thürlimann, Beat; Mouridsen, Henning; Mauriac, Louis; Forbes, John F; Paridaens, Robert; Láng, István; Smith, Ian; Chirgwin, Jacquie; Pienkowski, Tadeusz; Wardley, Andrew; Price, Karen N; Gelber, Richard D; Coates, Alan S; Goldhirsch, Aron

    2011-03-20

    Among postmenopausal women with endocrine-responsive breast cancer, the aromatase inhibitor letrozole, when compared with tamoxifen, has been shown to significantly improve disease-free survival (DFS) and time to distant recurrence (TDR). We investigated whether letrozole monotherapy prolonged overall survival (OS) compared with tamoxifen monotherapy. Of 8,010 postmenopausal women with hormone receptor-positive, early breast cancer enrolled on the Breast International Group (BIG) 1-98 study, 4,922 were randomly assigned to 5 years of continuous adjuvant therapy with either letrozole or tamoxifen. Of 2,459 patients enrolled in the tamoxifen treatment arm, 619 (25.2%) selectively crossed over to either adjuvant or extended letrozole after initial trial results were presented in January 2005. To gain better estimates of relative treatment effects in the presence of selective crossover, we used inverse probability of censoring weighted (IPCW) modeling. Weighted Cox models, by using IPCW, estimated a statistically significant, 18% reduction in the hazard of an OS event with letrozole treatment (hazard ratio [HR], 0.82; 95% CI, 0.70 to 0.95). Estimates of 5-year OS on the basis of IPCW were 91.8% and 90.4% for letrozole and tamoxifen, respectively. The HRs of DFS and TDR events by using IPCW modeling were 0.83 (95% CI, 0.74 to 0.94) and 0.80 (95% CI, 0.67 to 0.94), respectively (P < .05 for DFS, OS, and TDR). Median follow-up was 74 months. Adjuvant treatment with letrozole, compared with tamoxifen, significantly reduces the risk of death, the risk of recurrent disease, and the risk of recurrence at distant sites in postmenopausal women with hormone receptor-positive breast cancer.

  12. Addition of Nasal Cannula Can Either Impair or Enhance Preoxygenation With a Bag Valve Mask: A Randomized Crossover Design Study Comparing Oxygen Flow Rates.

    Science.gov (United States)

    McQuade, David; Miller, Matthew R; Hayes-Bradley, Clare

    2017-07-26

    A critical safety component of emergency anesthesia is the avoidance of hypoxemia during the apneic phase of a rapid sequence intubation. Preoxygenation with a bag valve mask (BVM) or anesthetic circuit may be improved with supplemental oxygen by nasal cannula (NC) if there is a mask leak. In addition, NC is recommended for apneic oxygenation after induction and may be placed before preoxygenation. However, the optimum NC flow rate for preoxygenation or whether the presence of NC alone creates a mask leak remains unclear. We performed a randomized crossover study on healthy volunteers comparing BVM alone and BVM with NC flow rates of 0 (NC-0), 5 (NC-5), 10 (NC-10), and 15 (NC-15) liters per minute (lpm). Our primary outcome was end-tidal oxygen (ETO2) after 3-minute preoxygenation. There was no difference in ETO2 between NC-15, NC-10, or BVM-only at 3 minutes. NC-0 and NC-5 recorded significantly lower ETO2 at all times compared with NC-15, NC-10, or BVM-only (least difference NC-5, -7% [95% confidence interval {CI}, -4% to -10%), NC-0, 16% [95% CI, 13%-19%]). There was a difference in ETO2 between NC-15 and BVM-only at 1 minute (7%; 95% CI, 5%-9%), but not at 2 or 3 minutes. There was no difference in ETO2 between NC-10 and NC-15. Our study found that NC at 0 and 5 lpm with a BVM is deleterious to preoxygenation and should be avoided. In addition, a lack of difference between NC-10 and BVM-only demonstrates that NC at flows of at least 10 lpm should not impair the preoxygenation process. While NC-15 may offer a benefit by reaching maximal ETO2 at 1 minute, this would need to be balanced against patient comfort.

  13. Faster reduction in hyperinflation and improvement in lung ventilation inhomogeneity promoted by aclidinium compared to glycopyrronium in severe stable COPD patients. A randomized crossover study.

    Science.gov (United States)

    Santus, Pierachille; Radovanovic, Dejan; Di Marco, Fabiano; Raccanelli, Rita; Valenti, Vincenzo; Centanni, Stefano

    2015-12-01

    Standard spyrometric assessment in chronic obstructive pulmonary disease (COPD) only evaluates bronchial obstruction. However, airflow limitation and hyperinflation are the main pathophysiological factors responsible for dyspnoea and reduced exercise tolerance in patients with COPD. This study evaluated the effects of aclidinium bromide 400 μg and glycopyrronium bromide 50 μg on these parameters. Patients with stable severe/very severe COPD were randomized in this double-blind, double-dummy, crossover, Phase IV study. Patients received single doses of each drug on separate days. Primary endpoints were changes in residual volume (RV) and intra-thoracic gas volume (ITGV), assessed by full-body plethysmography. Other endpoints included changes variations in lung ventilation inhomogeneity (Phase III slope of single-breath nitrogen washout test, SBN2), dyspnoea visual analogue scale, and pulmonary specific total airway resistances. Assessments were performed at baseline and 5, 15, 30, 60, and 180 min post-administration. Thirty-seven patients were randomized (31 male; mean age 71 years). Aclidinium and glycopyrronium significantly improved ITGV versus baseline at all-time points (p ventilation inhomogeneity versus baseline at all-time points; no significant changes were observed for glycopyrronium. For the first time two long-acting muscarinic antagonists have been compared in acute conditions with body plethysmography and SBN2 test. We demonstrated that both aclidinium and glycopyrronium significantly reduce hyperinflation and dyspnoea in severe and very severe COPD patients. Aclidinium however promoted a faster reduction in RV and was the only able to reduce lung ventilation inhomogeneity. Trial Registration numbers available on Clinicaltrials.gov: NCT02181023. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

    Science.gov (United States)

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

    2016-11-15

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

  15. Gesture-Controlled Image Management for Operating Room: A Randomized Crossover Study to Compare Interaction Using Gestures, Mouse, and Third Person Relaying.

    Science.gov (United States)

    Wipfli, Rolf; Dubois-Ferrière, Victor; Budry, Sylvain; Hoffmeyer, Pierre; Lovis, Christian

    2016-01-01

    In this work, we aim at comparing formally three different interaction modes for image manipulation that are usable in a surgery setting: 1) A gesture-controlled approach using Kinect ®; 2) oral instructions to a third part dedicated to manipulate the images; and 3) direct manipulation using a mouse. Each participant used the radiology image viewer Weasis with the three interaction modes. In a crossover randomized controlled trial participants were attributed block wise to six experimental groups. For each group, the order for testing the three modes was randomly assigned. Nine standardized scenarios were used. 30 physicians and senior medical students participated in the experiment. Efficiency, measured as time used to pass the scenario, was best when using the mouse (M = 109.10s, SD = 25.96), followed by gesture-controlled (M = 214.97s, SD = 46.29) and oral instructions (M = 246.33s, SD = 76.50). Satisfaction, measured by a questionnaire, was rated highest in the condition mouse (M = 6.63, SD = 0.56), followed by gesture-controlled (M = 5.77, SD = 0.93) and oral instructions (M = 4.40, SD = 1.71). Differences in efficiency and satisfaction rating were significant. No significant difference in effectiveness, measured with error rates, was found. The study shows with formal evaluation that the use of gestures is advantageous over instructions to a third person. In particular, the use of gestures is more efficient than verbalizing instructions. The given gestures could be learned easily and reliability of the tested gesture-control system is good. Under the premise that mouse cannot be used directly during surgery, gesture-controlled approaches demonstrate to be superior to oral instructions for image manipulation.

  16. A randomized, crossover, head-to-head comparison of eicosapentaenoic acid and docosahexaenoic acid supplementation to reduce inflammation markers in men and women: the Comparing EPA to DHA (ComparED) Study.

    Science.gov (United States)

    Allaire, Janie; Couture, Patrick; Leclerc, Myriam; Charest, Amélie; Marin, Johanne; Lépine, Marie-Claude; Talbot, Denis; Tchernof, André; Lamarche, Benoît

    2016-08-01

    To date, most studies on the anti-inflammatory effects of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in humans have used a mixture of the 2 fatty acids in various forms and proportions. We compared the effects of EPA supplementation with those of DHA supplementation (re-esterified triacylglycerol; 90% pure) on inflammation markers (primary outcome) and blood lipids (secondary outcome) in men and women at risk of cardiovascular disease. In a double-blind, randomized, crossover, controlled study, healthy men (n = 48) and women (n = 106) with abdominal obesity and low-grade systemic inflammation consumed 3 g/d of the following supplements for periods of 10 wk: 1) EPA (2.7 g/d), 2) DHA (2.7 g/d), and 3) corn oil as a control with each supplementation separated by a 9-wk washout period. Primary analyses assessed the difference in cardiometabolic outcomes between EPA and DHA. Supplementation with DHA compared with supplementation with EPA led to a greater reduction in interleukin-18 (IL-18) (-7.0% ± 2.8% compared with -0.5% ± 3.0%, respectively; P = 0.01) and a greater increase in adiponectin (3.1% ± 1.6% compared with -1.2% ± 1.7%, respectively; P DHA and EPA, changes in CRP (-7.9% ± 5.0% compared with -1.8% ± 6.5%, respectively; P = 0.25), IL-6 (-12.0% ± 7.0% compared with -13.4% ± 7.0%, respectively; P = 0.86), and tumor necrosis factor-α (-14.8% ± 5.1% compared with -7.6% ± 10.2%, respectively; P = 0.63) were NS. DHA compared with EPA led to more pronounced reductions in triglycerides (-13.3% ± 2.3% compared with -11.9% ± 2.2%, respectively; P = 0.005) and the cholesterol:HDL-cholesterol ratio (-2.5% ± 1.3% compared with 0.3% ± 1.1%, respectively; P = 0.006) and greater increases in HDL cholesterol (7.6% ± 1.4% compared with -0.7% ± 1.1%, respectively; P DHA compared with EPA was significant in men but not in women (P-treatment × sex interaction = 0.046). DHA is more effective than EPA in modulating specific markers of inflammation

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

    DEFF Research Database (Denmark)

    Engel, Sara; Elhauge, Mie; Tholstrup, Tine

    2017-01-01

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

  18. Comparative pharmacokinetics of equimolar doses of 5-aminosalicylate administered as oral mesalamine (Asacol) and balsalazide: a randomized, single-dose, crossover study in healthy volunteers.

    Science.gov (United States)

    Sandborn, W J; Hanauer, S B; Buch, A

    2004-05-15

    Existing pharmacokinetic data are insufficient to determine whether a delayed-release formulation of mesalamine (Asacol) results in greater systemic exposure to 5-aminosalicylic acid and its major metabolite N-acetyl-5-aminosalicylic acid than a prodrug (balsalazide). To determine the pharmacokinetic parameters of 5-aminosalicylic acid and N-acetyl-5-aminosalicylic acid from equimolar doses of 5-aminosalicylic acid administered as Asacol and balsalazide. Nineteen healthy volunteers completed an open-label, single-dose, randomized, crossover study comparing the pharmacokinetics of 5-aminosalicylic acid and N-acetyl-5-aminosalicylic acid from equimolar doses of 5-aminosalicylic acid (800 mg) administered as Asacol (800 mg) and balsalazide (2250 mg). Plasma and urine samples were analysed for 5-aminosalicylic acid, N-acetyl-5-aminosalicylic acid, and balsalazide (urine only) using high-performance liquid chromatography methods with mass spectrometric detection. Pharmacokinetic parameters assessed for 5-aminosalicylic acid and N-acetyl-5-aminosalicylic acid included: percentage of dose excreted in urine (A(e)%), area under the plasma concentration-time curve (AUCt(last)); and maximum plasma concentration (C(max)). The geometric mean total (5-aminosalicylic acid and N-acetyl-5-aminosalicylic acid) urinary excretion values (A(e)%) of Asacol and balsalazide were 19.26 and 19.31% (P = 0.98). The geometric mean A(e)% values of 5-aminosalicylic acid for Asacol and balsalazide were 0.39 and 0.37% (P = 0.78); the geometric mean A(e)% values of N-acetyl-5-aminosalicylic acid for Asacol and balsalazide were 18.78 and 18.83% (P = 0.98). The geometric mean 5-aminosalicylic acid AUC(t(last)) values for Asacol and balsalazide were 3295 and 3449 ng h/mL (P = 0.85); the geometric mean N-acetyl-5-aminosalicylic acid AUC(t(last)) values for Asacol and balsalazide were 15 364 and 16 050 ng h/mL (P = 0.69). The geometric mean 5-5-aminosalicylic acid C(max) values for Asacol and

  19. Internet-administered Health-related Quality of Life Questionnaires Compared With Pen and Paper in an Adolescent Scoliosis Population: A Randomized Crossover Study.

    Science.gov (United States)

    Nitikman, Michael; Mulpuri, Kishore; Reilly, Christopher W

    2017-03-01

    Modern technology puts into question the effectiveness of using pen and paper as a means of collecting information from web-enabled patients. This study aimed to validate and test the reliability of using the Internet as a method of administering health-related quality of life questionnaires in a pediatric spine population. A prospective randomized crossover study was conducted. Patients aged 11 to 18 with idiopathic scoliosis were invited to participate, and informed consent was obtained from a scoliosis outpatient clinic setting. Participants were randomized to one of 4 groups determining the method of questionnaire administration [Scoliosis Research Society 30 (SRS-30) and Pediatric Outcomes Data Collection Instrument (PODCI)]. Both questionnaires were completed at 2 separate timepoints and 2 weeks apart to prevent recall bias. Groups included: Paper/Paper, Paper/Internet, Internet/Paper, and Internet/Internet. Paired-samples t tests were used to determine the test-retest reliability of each group. Analysis was stratified for surveys returned within or outside of the allotted 4-week timeframe following enrollment. Of the 96 participants who completed and returned both sets of questionnaires, 26 were allocated to the Paper/Paper group (27%), 20 to the Paper/Internet group (21%), 26 to the Internet/Paper group (27%), and 24 to the Internet/Internet group (25%). The second iteration of questionnaires was returned on time by 69 of the participants (71.2%). Of the late questionnaires, 18 (67%) were paper forms. Overall, no differences were observed between Internet-administered compared with pen and paper-administered questionnaires (P=0.206). No differences were observed within any group individually for either the SRS-30 or PODCI questionnaire. In addition, no significant differences were observed within groups for surveys returned within or outside of the 4-week timeframe. Eighty-four percent of the participants who completed both paper and Internet versions of

  20. Topical diclofenac does not affect the antiplatelet properties of aspirin as compared to the intermediate effects of oral diclofenac: A prospective, randomized, complete crossover study.

    Science.gov (United States)

    Rowcliffe, M; Nezami, B; Westphal, E S; Rainka, M; Janda, M; Bates, V; Gengo, F

    2016-04-01

    Nonsteroidal anti-inflammatory drugs (NSAIDs) adversely interact with aspirin, diminishing its antiplatelet effect and potentially placing patients at an increased risk for recurrent thrombotic events. This crossover study aimed to determine whether the topical NSAID diclofenac epolamine 1.3% patch or oral diclofenac 50 mg interfered with the antiplatelet effects of aspirin 325 mg. Twelve healthy men and women aged 18-50 were included. Participants were randomized into 5 treatment arms: aspirin, diclofenac potassium 50 mg, diclofenac patch, diclofenac potassium plus ASA 325 mg, and diclofenac patch plus aspirin. Platelet responsiveness was determined using whole-blood impedance aggregation (WBA) to collagen 1 μg/mL and arachidonic acid (AA) 0.5 mM and was sampled every 2 hours. No significant difference in platelet function was observed following the diclofenac patch and aspirin vs aspirin alone. Oral diclofenac produced a mixed effect with significant reduction in platelet inhibition at hour 2 and hour 8 following aspirin administration. Topical diclofenac does not significantly interfere with the antiplatelet effects of aspirin and may be a safer alternative to the oral formulation. © 2015, The American College of Clinical Pharmacology.

  1. Early functional postoperative therapy of distal radius fracture with a dynamic orthosis: results of a prospective randomized cross-over comparative study.

    Directory of Open Access Journals (Sweden)

    Fabian M Stuby

    Full Text Available This study was conducted according to GCP criteria as a prospective randomized cross-over study. The primary goal of the study was to determine clinical findings and patient satisfaction with postoperative treatment. 29 patients with a distal radius fracture that was surgically stabilized from volar and who met the inclusion criteria were enrolled over a 12-month period. Each patient randomly received either a dorsal plaster splint or a vacuum-fit flexible but blocked orthosis applied postoperatively in the operating theatre to achieve postoperative immobilization. After one week all patients were crossed over to the complementary device maintaining the immobilization until end of week 2. After week 2 both groups were allowed to exercise wrist mobility with a physiotherapist, in the orthosis group the device was deblocked, thus allowing limited wrist mobility. After week 4 the devices were removed in both groups. Follow-up exams were performed after postoperative weeks 1, 2, 4 and 12.Results were determined after week 1 and 2 using SF 36 and a personally compiled questionnaire; after weeks 4 and 12 with a clinical check-up, calculation of ROM and the DASH Score. Comparison of the two groups showed a significant difference in ROM for volar flexion after 4 weeks, but no significant differences in DASH Score, duration of disability or x-ray findings. With regard to satisfaction with comfort and hygiene, patients were significantly more satisfied with the dynamic orthosis, and 23 of the 29 patients would prefer the flexible vacuum orthosis in future.German Clinical Trials Register (DRKS DRKS00006097.

  2. Early functional postoperative therapy of distal radius fracture with a dynamic orthosis: results of a prospective randomized cross-over comparative study.

    Science.gov (United States)

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

    2015-01-01

    This study was conducted according to GCP criteria as a prospective randomized cross-over study. The primary goal of the study was to determine clinical findings and patient satisfaction with postoperative treatment. 29 patients with a distal radius fracture that was surgically stabilized from volar and who met the inclusion criteria were enrolled over a 12-month period. Each patient randomly received either a dorsal plaster splint or a vacuum-fit flexible but blocked orthosis applied postoperatively in the operating theatre to achieve postoperative immobilization. After one week all patients were crossed over to the complementary device maintaining the immobilization until end of week 2. After week 2 both groups were allowed to exercise wrist mobility with a physiotherapist, in the orthosis group the device was deblocked, thus allowing limited wrist mobility. After week 4 the devices were removed in both groups. Follow-up exams were performed after postoperative weeks 1, 2, 4 and 12. Results were determined after week 1 and 2 using SF 36 and a personally compiled questionnaire; after weeks 4 and 12 with a clinical check-up, calculation of ROM and the DASH Score. Comparison of the two groups showed a significant difference in ROM for volar flexion after 4 weeks, but no significant differences in DASH Score, duration of disability or x-ray findings. With regard to satisfaction with comfort and hygiene, patients were significantly more satisfied with the dynamic orthosis, and 23 of the 29 patients would prefer the flexible vacuum orthosis in future. German Clinical Trials Register (DRKS) DRKS00006097.

  3. Acti-Tape™ (elastic therapeutic tape as compared with a knee guard in providing support to the knee joint: an open-label, randomized, crossover study

    Directory of Open Access Journals (Sweden)

    Hui HK

    2014-04-01

    Full Text Available Hoong Keong Hui,1 Narayan J Karne,2 Navneet Sonawane31Nutriworks Ltd, Kowloon, Hong Kong; 2Karne Hospital, Pune, India; 3Vedic Lifesciences Pvt Ltd, Mumbai, IndiaStudy design: Randomized, open-label, crossover, controlled study.Background: Elastic taping methods are used to provide support to the musculoskeletal system in athletes. Acti-Tape™ (an elastic therapeutic tape has been marketed for the last 2–3 years and has shown good results in providing support to the joints. This pilot study was planned to collect data on the clinical outcomes and to assess if a single tape application of Acti-Tape over the knee joint could provide benefits similar to a traditionally used knee guard.Methods: Thirteen subjects aged 30–65 years visiting an orthopedic center in Pune, India who were suffering from osteoarthritis were randomly assigned to either Acti-Tape (n=6 or a knee guard (n=7 in the first intervention period (6 days and were crossed over to the other group in the second intervention period (6 days after a washout of 1 day. Main outcome measures were change from day 0 to day 6 in pain visual analog score (VAS; timed up and go (TUG, medial step down (MSD, and unilateral anterior reach (UAR tests; and subject's preference.Results: Data for all the 13 subjects were pooled and analyzed by Student's t-test as treatment-by-period interaction was not significant by analysis of variance (P>0.05. The changes (mean ± standard deviation after using Acti-Tape and a knee guard, respectively, were pain VAS, –10±5.4 versus (vs –11.5±5.83; TUG, –0.62±1.33 vs –0.46±1.56; UAR, 0.15±1.07 vs 0.75±0.44; and MSD, 1.08±095 vs 0.85±1.14. These were statistically significant with both devices for pain VAS, UAR, and MSD, but not for TUG. Between the treatments however, no statistically significant difference was seen. Eleven of 13 (85% subjects preferred Acti-Tape for future use (P<0.05 by McNemar’s χ2 test. No safety concerns were reported by the

  4. A controlled, crossover study of a persistent antiseptic to reduce ...

    African Journals Online (AJOL)

    acquired infection. ... Materials and Methods: A controlled, crossover study was conducted in three wards of a hospital over the course of three months. Two months were ... The product was well tolerated by the staff and improved skin condition.

  5. Comparative bioavailability and pharmacokinetics of two oral formulations of flurbiprofen: a single-dose, randomized, open-label, two-period, crossover study in Pakistani subjects.

    Science.gov (United States)

    Qayyum, Aisha; Najmi, Muzammil Hasan; Abbas, Mateen

    2013-11-01

    Comparative bioavailability studies are conducted to establish the bioequivalence of generic formulation with that of branded reference formulation, providing confidence to clinicians to use these products interchangeably. This study was carried out to compare a locally manufactured formulation of flurbiprofen with that of a branded product. Twenty two healthy male adults received a single dose of flurbiprofen (100mg) either generic or branded product according to randomization scheme on each of 2 periods. Blood samples were collected and plasma flurbiprofen concentration was determined by a validated HPLC method. Pharmacokinetic parameters like AUC(0-t), AUC(0-oo), Cmax, Tmax, t½, Vd and clearance were determined. The 90% CI for the ratio of geometric means of test to reference product's pharmacokinetic variables was calculated. Pharmacokinetic parameters for two formulations were comparable. Ratio of means of AUC(0-24), AUC(0-oo) and Cmax for test to reference products and 90% CI for these ratios were within the acceptable range. The p-values calculated by TOST were much less than the specified value (p-0.05). ANOVA gave p-values which were more than the specified value (p-0.05) for sequence, subject, period and formulation. Test formulation of flurbiprofen (tablet Flurso) was found to meet the criteria for bioequivalence to branded product (tablet Ansaid) based on pharmacokinetic parameters.

  6. Randomized, open-label, blinded-endpoint, crossover, single-dose study to compare the pharmacodynamics of torasemide-PR 10 mg, torasemide-IR 10 mg, and furosemide-IR 40 mg, in patients with chronic heart failure.

    Science.gov (United States)

    Ballester, Maria Rosa; Roig, Eulàlia; Gich, Ignasi; Puntes, Montse; Delgadillo, Joaquín; Santos, Benjamín; Antonijoan, Rosa Maria

    2015-01-01

    Diuretics are the primary treatment for the management of chronic heart failure (HF) symptoms and for the improvement of acute HF symptoms. The rate of delivery to the site of action has been suggested to affect diuretic pharmacodynamics. The main objective of this clinical trial was to explore whether a prolonged release tablet formulation of torasemide (torasemide-PR) was more natriuretically efficient in patients with chronic HF compared to immediate-release furosemide (furosemide-IR) after a single-dose administration. Moreover, the pharmacokinetics of torasemide-PR, furosemide-IR, and torasemide-IR were assessed in chronic HF patients as well as urine pharmacodynamics. Randomized, open-label, blinded-endpoint, crossover, and single-dose Phase I clinical trial with three experimental periods. Torasemide-PR and furosemide-IR were administered as a single dose in a crossover fashion for the first two periods, and torasemide-IR 10 mg was administered for the third period. Blood and urine samples were collected at fixed timepoints. The primary endpoint was the natriuretic efficiency after administration of torasemide-PR and furosemide-IR, defined as the ratio between the average drug-induced natriuresis and the average drug recovered in urine over 24 hours. Ten patients were included and nine completed the study. Here, we present the results from nine patients. Torasemide-PR was more natriuretically efficient than furosemide-IR (0.096 ± 0.03 mmol/μg vs 0.015 ± 0.0007 mmol/μg; P furosemide-IR. In a study with a limited sample size, our results suggest that 10 mg of torasemide-PR is more natriuretically efficient than 40 mg of furosemide-IR after single-dose administration in patients with chronic HF over a 24-hour collection period. Further studies are necessary to evaluate potential pharmacodynamic differences between torasemide formulations and to assess its impact on clinical therapeutics.

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

    DEFF Research Database (Denmark)

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

    2013-01-01

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

  8. Auriculotherapy fails to relieve chronic pain. A controlled crossover study.

    Science.gov (United States)

    Melzack, R; Katz, J

    1984-02-24

    Enthusiastic reports of the effectiveness of electrical stimulation of the outer ear for the relief of pain ("auriculotherapy") have led to increasing use of the procedure. In the present study, auriculotherapy was evaluated in 36 patients suffering from chronic pain, using a controlled crossover design. The first experiment compared the effects of stimulation of designated auriculotherapy points, and of control points unrelated to the painful area. A second experiment compared stimulation of designated points with a no-stimulation placebo control. Pain-relief scores obtained with the McGill Pain Questionnaire failed to show any differences in either experiment. It is concluded that auriculotherapy is not an effective therapeutic procedure for chronic pain.

  9. Analyses adjusting for selective crossover show improved overall survival with adjuvant letrozole compared with tamoxifen in the BIG 1-98 study

    DEFF Research Database (Denmark)

    Colleoni, Marco; Giobbie-Hurder, Anita; Regan, Meredith M

    2011-01-01

    Among postmenopausal women with endocrine-responsive breast cancer, the aromatase inhibitor letrozole, when compared with tamoxifen, has been shown to significantly improve disease-free survival (DFS) and time to distant recurrence (TDR). We investigated whether letrozole monotherapy prolonged...

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

    Science.gov (United States)

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

    2016-01-01

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

  11. Theoretical Study of Spin Crossover in 30 Iron Complexes

    DEFF Research Database (Denmark)

    Kepp, Kasper Planeta

    2016-01-01

    Spin crossover was studied in 30 iron complexes using density functional theory to quantify the direction and magnitude of dispersion, relativistic effects, zero-point energies, and vibrational entropy. Remarkably consistent entropy−enthalpy compensation was identified. Zero-point energies favor ...

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

    NARCIS (Netherlands)

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

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

  13. Bioequivalence and Safety of Twice-Daily Sustained-Release Paracetamol (Acetaminophen) Compared With 3- and 4-Times-Daily Paracetamol: A Repeat-Dose, Crossover Pharmacokinetic Study in Healthy Volunteers.

    Science.gov (United States)

    Liu, Dongzhou J; Collaku, Agron

    2018-01-01

    Twice-daily sustained-release (SR) paracetamol (acetaminophen) offers convenient administration to chronic users. This study investigated at steady state (during the last 24 hours of a 3-day dosing period) the pharmacokinetics, bioequivalence, and safety of twice-daily SR paracetamol compared with extended-release (ER) and immediate-release (IR) paracetamol. In this open-label, randomized, multidose, 3-way crossover study, 28 healthy subjects received paracetamol SR (2 × 1000 mg twice daily), ER (2 × 665 mg 3 times daily), and IR (2 × 500 mg 4 times daily). At steady state, twice-daily SR paracetamol was bioequivalent to ER and IR paracetamol. The 90% confidence intervals for the ratios of geometric means were within the acceptance interval for SR/ER paracetamol (AUC 0-t , 0.973-1.033; AUC 0-24 , 0.974-1.034; AUC 0-∞ , 0.948-1.011; C max , 1.082-1.212; C av , 1.011-1.106) and SR/IR paracetamol (AUC 0-t , 0.969-1.029; AUC 0-24 , 0.968-1.027; AUC 0-∞ , 0.963-1.026; C max , 0.902-1.010; C av , 1.004-1.098). Given twice daily, the SR formulation demonstrated SR properties as expected. Mean time at or above a 4 μg/mL plasma concentration of paracetamol from 2 daily doses of the SR formulation was significantly longer than that from 4 daily doses of IR paracetamol. SR formulation also had a greater T max , a longer half-life, and lower C min compared with ER and IR paracetamol. All formulations were well tolerated. © 2017, The American College of Clinical Pharmacology.

  14. Acid-inhibitory effects of vonoprazan 20 mg compared with esomeprazole 20 mg or rabeprazole 10 mg in healthy adult male subjects--a randomised open-label cross-over study.

    Science.gov (United States)

    Sakurai, Y; Mori, Y; Okamoto, H; Nishimura, A; Komura, E; Araki, T; Shiramoto, M

    2015-09-01

    Proton pump inhibitors (PPIs) are widely used for the treatment of acid-related diseases. Vonoprazan is a member of a new class of acid suppressants; potassium-competitive acid blockers. Vonoprazan may thus be an alternative to PPIs. To evaluate efficacy, rapidity and duration of acid-inhibitory effects of vonoprazan vs. two control PPIs, esomeprazole and rabeprazole, in 20 healthy Japanese adult male volunteers with CYP2C19 extensive metaboliser genotype. In this randomised, open-label, two-period cross-over study, vonoprazan 20 mg and esomeprazole 20 mg (Study V vs. E) or rabeprazole 10 mg (Study V vs. R) were orally administered daily for 7 days. Primary pharmacodynamic endpoint was gastric pH over 24 h measured as percentage of time pH ≥3, ≥4 and ≥5 (pH holding time ratios; HTRs) and mean gastric pH. Acid-inhibitory effect (pH4 HTR) of vonoprazan was significantly greater than that of esomeprazole or rabeprazole on both Days 1 and 7; Day 7 difference in pH4 HTR for vonoprazan vs. esomeprazole was 24.6% [95% confidence interval (CI): 16.2-33.1] and for vonoprazan vs. rabeprazole 28.8% [95% CI: 17.2-40.4]. The Day 1 to Day 7 ratio of 24-h pH4 HTRs was >0.8 for vonoprazan, compared with 0.370 for esomeprazole and 0.393 for rabeprazole. Vonoprazan was generally well tolerated. One vonoprazan subject withdrew due to a rash which resolved after discontinuation. This study demonstrated a more rapid and sustained acid-inhibitory effect of vonoprazan 20 mg vs. esomeprazole 20 mg or rabeprazole 10 mg. Therefore, vonoprazan may be a potentially new treatment for acid-related diseases. © 2015 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

  15. Dual Bronchodilation with Indacaterol Maleate/Glycopyrronium Bromide Compared with Umeclidinium Bromide/Vilanterol in Patients with Moderate-to-Severe COPD: Results from Two Randomized, Controlled, Cross-over Studies.

    Science.gov (United States)

    Kerwin, Edward; Ferguson, Gary T; Sanjar, Shahin; Goodin, Thomas; Yadao, Anthony; Fogel, Robert; Maitra, Samopriyo; Sen, Biswajit; Ayers, Tim; Banerji, Donald

    2017-12-01

    To compare the efficacy and safety of two long-acting dual bronchodilator combinations: indacaterol/glycopyrrolate (IND/GLY) versus umeclidinium/vilanterol (UMEC/VI). Studies A2349 and A2350 were replicate, randomized, double-blind, double-dummy, active-controlled, cross-over studies in patients with moderate-to-severe COPD. Patients were randomized to sequential 12-week treatments of twice-daily IND/GLY 27.5/15.6 μg and once-daily UMEC/VI 62.5/25 μg, each separated by a 3-week washout. The primary objective was to demonstrate non-inferiority of IND/GLY compared with UMEC/VI in terms of the 24-h forced expiratory volume in 1 s profile at week 12 (FEV 1 AUC 0-24 ). Rescue medication use, symptom control, and safety were assessed throughout. Both treatments delivered substantial bronchodilation over 12 weeks, with improvements in FEV 1 AUC 0-24h at week 12 of 232 and 185 mL for IND/GLY, and 244 and 203 mL with UMEC/VI in Studies A2349 and A2350, respectively. The primary efficacy objective of non-inferiority of IND/GLY relative to UMEC/VI was not met as the lower bound of the confidence interval for the LS treatment comparison was below the pre-specified non-inferiority margin of -20 mL in both studies: -26.9 and -34.2 mL, respectively (LS mean between-treatment differences: -11.5 and -18.2 mL). Both drugs were well tolerated, with AE profiles consistent with their respective prescribing information. IND/GLY and UMEC/VI provided clinically meaningful and comparable bronchodilation. Non-inferiority of IND/GLY to UMEC/VI could not be declared although between-treatment differences were not clinically relevant. The data support the use of IND/GLY as an efficacious and well tolerated treatment option in patients with COPD. (ClinicalTrials.gov NCT02487446 and NCT02487498).

  16. Are antibiotics related to oral combination contraceptive failures in the Netherlands? A case-crossover study

    NARCIS (Netherlands)

    Koopmans, P.C.; Bos, J.H.; de Jong-van den Berg, L.T.

    Purpose To investigate whether there is an association between use of antibiotics and breakthrough pregnancy. Methods The study was performed in a population-based prescription database (IADB.nl). We computed case-crossover odds ratios of 397 cases of defined breakthrough pregnancy comparing the use

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

    NARCIS (Netherlands)

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

    2016-01-01

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

  18. A COMPARATIVE STUDY OF EFFICACY AND TOLERABILITY OF GENERIC AND ORIGINAL LOW-DOSE BISOPROLOL/HYDROCHLOROTHIAZIDE COMBINATION IN PATIENTS WITH ARTERIAL HYPERTENSION OF 1-2 DEGREES. RESULTS OF CLINICAL RANDOMIZED CROSSOVER STUDY

    Directory of Open Access Journals (Sweden)

    S. Yu. Martsevich

    2015-09-01

    Full Text Available Aim. To study the clinical equivalence of the two low-dose combined drugs on the base of generic and original bisoprolol and hydrochlorothiazide (HCTZ: BISANGIL® (Ozon, Russia and LODOZ® (NYCOMED, Merck KGaA, Germany in patients with arterial hypertension (HT of 1-2 degrees.Material and methods. Patients with HT of 1-2 degrees (n=30; 11 men and 19 women; aged 62.7±10.7 years were included in open crossover randomized trial. Duration of the study for each patient was 18 weeks: two 6-week courses of active treatment with each drug and two 2-week washout periods prior to each treatment course. The sequence of treatment courses was determined by randomization. Increase in bisoprolol dose and/or amlodipine addition occurred when effect was not sufficient. Therapy effectiveness (office blood pressure (BP, heart rate and safety was monitored at visits.Results. BP reduction after 6 weeks of therapy was -21.6±11.1/10.4±11.3 mm Hg in LODOZ® group and -22.9±9.7/11.7±13.5 mm Hg in BISANGIL® group (p<0.0001 for both, intergroup differences were insignificant. Target BP after 6 weeks of therapy was achieved in 26 (87% and 28 (93% patients, respectively.Conclusion. The therapeutic equivalence of the studied fixed combinations of bisoprolol/HCTZ was demonstrated in treatment of patients with HT of 1-2 degrees.

  19. Influence analysis on crossover design experiment in bioequivalence studies.

    Science.gov (United States)

    Huang, Yufen; Ke, Bo-Shiang

    2014-01-01

    Crossover designs are commonly used in bioequivalence studies. However, the results can be affected by some outlying observations, which may lead to the wrong decision on bioequivalence. Therefore, it is essential to investigate the influence of aberrant observations. Chow and Tse in 1990 discussed this issue by considering the methods based on the likelihood distance and estimates distance. Perturbation theory provides a useful tool for the sensitivity analysis on statistical models. Hence, in this paper, we develop the influence functions via the perturbation scheme proposed by Hampel as an alternative approach on the influence analysis for a crossover design experiment. Moreover, the comparisons between the proposed approach and the method proposed by Chow and Tse are investigated. Two real data examples are provided to illustrate the results of these approaches. Our proposed influence functions show excellent performance on the identification of outlier/influential observations and are suitable for use with small sample size crossover designs commonly used in bioequivalence studies. Copyright © 2013 John Wiley & Sons, Ltd.

  20. Treadmill training with partial body weight support compared with conventional gait training for low-functioning children and adolescents with nonspastic cerebral palsy: a two-period crossover study.

    Science.gov (United States)

    Su, Ivan Y W; Chung, Kenny K Y; Chow, Daniel H K

    2013-12-01

    Partial body weight-supported treadmill training has been shown to be effective in gait training for patients with neurological disorders such as spinal cord injuries and stroke. Recent applications on children with cerebral palsy were reported, mostly on spastic cerebral palsy with single subject design. There is lack of evidence on the effectiveness of such training for nonspastic cerebral palsy, particularly those who are low functioning with limited intellectual capacity. This study evaluated the effectiveness of partial body weight-supported treadmill training for improving gross motor skills among these clients. A two-period randomized crossover design with repeated measures. A crossover design following an A-B versus a B-A pattern was adopted. The two training periods consisted of 12-week partial body weight-supported treadmill training (Training A) and 12-week conventional gait training (Training B) with a 10-week washout in between. Ten school-age participants with nonspastic cerebral palsy and severe mental retardation were recruited. The Gross Motor Function Measure-66 was administered immediately before and after each training period. Significant improvements in dimensions D and E of the Gross Motor Function Measure-66 and the Gross Motor Ability Estimator were obtained. Our findings revealed that the partial body weight-supported treadmill training was effective in improving gross motor skills for low-functioning children and adolescents with nonspastic cerebral palsy. .

  1. [Comparative studies of the response of normolipemic and dyslipemic aged subjects to 2 forms of delayed-action nicotinic acid polyesters. Pentaerythrotol tetranicotinate and inositol hexanicotinate. Results of a controlled cross-over trial].

    Science.gov (United States)

    Ziliotto, G R; Lamberti, G; Wagner, A; Cima, L; Genco, G

    1977-01-01

    A cross-over trial was run to compare the effects of two delayed-action nicotinic acid polyesters (pentaerythritol-tetranticotinate, PETN, and inositol-hexanicotinate, MIEN) in 59 aged normo- and dyslipaemic subjects. PETN tended to normalise the lipid picture in much the same way as nicotin acid, without a drastic effect on circulating lipids and lipoproteins. MIEN, on the other hand, had only a slight effect on total blood lipids, and appeared to be ineffective or negative with respect to the other lipid parameters. PETN proved capable of releasing active concentrations of nicotinic acid in vivo for a period of time that was sufficient to correct hyperlipaemia in age subjects. The side-effects were slight, infrequent and quickly reversible.

  2. 1-Set vs. 3-set resistance training: a crossover study.

    Science.gov (United States)

    Humburg, Hartmut; Baars, Hartmut; Schröder, Jan; Reer, Rüdiger; Braumann, Klaus-Michael

    2007-05-01

    This crossover study was conducted to investigate the effects of a 1-set and 3-set strength training program. The subjects were untrained men and women who were randomly signed into 1 of 3 groups: 10 subjects trained during the first 9 weeks (training period 1) with 1 set and 8-12 repetitions per set. After the break (9 weeks), they trained with 3 sets and 8-12 repetitions in training period 2. Twelve subjects started with the 3-set program and continued with the 1-set regime after the break. The control group (n = 7) did not train. The subjects were tested on 1 repetition maximum (1RM) for the biceps curl, leg press (unilateral: left and right), and bench press. Analysis of the data was done in a sampled manner for each strength training program (1-set and 3-set). The 1-set (n = 22) and 3-set (n = 22) programs led to significantly (p < 0.05) improved 1RM performances in every exercise. The relative improvements (%) for the 1RM were significantly higher during the 3-set program for the biceps curl and the bench press compared with the 1-set program. The control group exhibited no changes in any of the tested parameters over the course of this study. The design of this study allowed insight into the effects of different strength training volume without any genetical variations. The same subjects improved their 1RM during the 3-set program by 2.3 kg (biceps curl; corresponding effect size = 0.24), 8.9 kg (leg press right; 0.30), 10.9 kg (leg press left; 0.28), and 2.5 kg (bench press; 0.09) more than during the 1-set program. Depending on the goals of each trainee, these differences between the effects of different strength training volumes indicate that it may be worth spending more time on working out with a 3-set strength training regime.

  3. Randomized, open-label, single-dose, crossover, relative bioavailability study in healthy adults, comparing the pharmacokinetics of rabeprazole granules administered using soft food or infant formula as dosing vehicle versus suspension.

    Science.gov (United States)

    Thyssen, An; Solanki, Bhavna; Treem, William

    2012-07-01

    A sprinkle capsule formulation containing enteric-coated, delayed-release rabeprazole granules is being developed for the treatment of children with gastrointestinal reflux disease. The granules are designed to be mixed with vehicles that facilitate delivery to children, who may be unable to swallow solid formulations. The primary objective of this study-conducted on the sponsor's initiative-was to compare the bioavailability of rabeprazole granules when mixed with various dosing vehicles (small amount of soft food or infant formula) with that of a rabeprazole suspension with inactive vehicle granules (reference), to determine which dosing vehicle can be used to deliver rabeprazole in children. Tolerability was also assessed. This single-center, single-dose, randomized, open-label, 5-period crossover study was conducted in 35 healthy adult subjects. In a randomized sequence, fasting subjects received a single dose of 10-mg rabeprazole granules per treatment period, mixed with small amounts of 1 of 5 dosing vehicles (a strawberry-flavored suspension of rabeprazole granules with inactive vehicle granules reconstituted with water, yogurt [1 tablespoon], applesauce [1 tablespoon], or infant formula [5 mL], or a suspension of rabeprazole granules with inactive vehicle tablet reconstituted with water). Full plasma pharmacokinetic (PK) profiles of rabeprazole and its thioether metabolite were collected; concentrations were estimated via LC-MS/MS. PK properties were estimated using noncompartmental methods; 90% CIs around least squares mean test-to-reference ratios were calculated for C(max) and AUC values. All treatment-emergent adverse events (TEAEs) were recorded and assessed for severity (mild, moderate, or severe) and relationship to study drug. A total of 35 subjects were enrolled (mean age, 38 years; 54.3% female; 100% white; mean weight, 71.4 kg). Thirty-four subjects completed the study. Rabeprazole and rabeprazole thioether plasma PK properties were comparable

  4. Triggers for Preeclampsia Onset: a Case-Crossover Study.

    Science.gov (United States)

    Ford, Jane B; Schemann, Kathrin; Patterson, Jillian A; Morris, Jonathan; Herbert, Robert D; Roberts, Christine L

    2016-11-01

    Risk factors for preeclampsia are well established, whereas, the triggers associated with timing of preeclampsia onset are not. The aim of this study was to establish whether recent infection or other triggers were associated with timing of preeclampsia onset. We used a case-crossover design with preeclampsia cases serving as their own controls. Women with singleton pregnancies of ≥20 weeks gestation presenting at three hospitals were eligible for inclusion. Exposures to potential triggers were identified via guided questionnaire. Infective episodes included symptoms lasting >24 h. Preeclampsia was defined as hypertension (BP ≥140 mmHg and/or ≥90 mmHg) and proteinuria (protein/creatinine ratio ≥30 mg/mmol). Conditional logistic regression was used to compare the odds of exposure to potential triggers in the case windows (1-7 days preceding diagnosis of preeclampsia) and control windows (8-14 days prior to diagnosis); unadjusted odds ratios (ORs) are reported. Among 286 recruited women, 25 (8.7%) reported a new infection in the 7 days prior to preeclampsia onset and 21 (7.3%) in the 8-14 days prior. There was no significant association between onset of infection in the 7 days prior and preeclampsia diagnosis (OR 1.24, 95% CI 0.65, 2.34). Consumption of caffeine (OR 0.51, 95% CI 0.33, 0.77), spicy food (OR 0.49, 95% CI 0.30, 0.81), and alcohol (OR 0.26, 95% CI 0.10, 0.71) were strongly inversely associated with preeclampsia onset. Recent infection does not appear to trigger preeclampsia. Decreased consumption of caffeine, spicy food, and alcohol may be prodromal markers. Such behaviours may be early markers of imminent preeclampsia. © 2016 John Wiley & Sons Ltd.

  5. Crossover learning of gestures in two ideomotor apraxia patients: A single case experimental design study.

    Science.gov (United States)

    Shimizu, Daisuke; Tanemura, Rumi

    2017-06-01

    Crossover learning may aid rehabilitation in patients with neurological disorders. Ideomotor apraxia (IMA) is a common sequela of left-brain damage that comprises a deficit in the ability to perform gestures to verbal commands or by imitation. This study elucidated whether crossover learning occurred in two post-stroke IMA patients without motor paralysis after gesture training approximately 2 months after stroke onset. We quantitatively analysed the therapeutic intervention history and investigated whether revised action occurred during gesture production. Treatment intervention was to examine how to influence improvement and generalisation of the ability to produce the gesture. This study used an alternating treatments single-subject design, and the intervention method was errorless learning. Results indicated crossover learning in both patients. Qualitative analysis indicated that revised action occurred during the gesture-production process in one patient and that there were two types of post-revised action gestures: correct and incorrect gestures. We also discovered that even when a comparably short time had elapsed since stroke onset, generalisation was difficult. Information transfer between the left and right hemispheres of the brain via commissural fibres is important in crossover learning. In conclusion, improvements in gesture-production skill should be made with reference to the left cerebral hemisphere disconnection hypothesis.

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

    National Research Council Canada - National Science Library

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

    2016-01-01

    .... SFA from a vegan-alternative test meal on postprandial inflammatory markers, a randomised controlled cross-over trial was conducted in twenty overweight or obese adults with metabolic abnormalities...

  7. Optimal adaptive sequential designs for crossover bioequivalence studies.

    Science.gov (United States)

    Xu, Jialin; Audet, Charles; DiLiberti, Charles E; Hauck, Walter W; Montague, Timothy H; Parr, Alan F; Potvin, Diane; Schuirmann, Donald J

    2016-01-01

    In prior works, this group demonstrated the feasibility of valid adaptive sequential designs for crossover bioequivalence studies. In this paper, we extend the prior work to optimize adaptive sequential designs over a range of geometric mean test/reference ratios (GMRs) of 70-143% within each of two ranges of intra-subject coefficient of variation (10-30% and 30-55%). These designs also introduce a futility decision for stopping the study after the first stage if there is sufficiently low likelihood of meeting bioequivalence criteria if the second stage were completed, as well as an upper limit on total study size. The optimized designs exhibited substantially improved performance characteristics over our previous adaptive sequential designs. Even though the optimized designs avoided undue inflation of type I error and maintained power at ≥ 80%, their average sample sizes were similar to or less than those of conventional single stage designs. Copyright © 2015 John Wiley & Sons, Ltd.

  8. Study of active crossover network | Tyona | Nigerian Journal of Physics

    African Journals Online (AJOL)

    An active crossover network system has been realized using an active component LF356 with a JFET input. The net work has two drives, the low frequency drive (Bass) and the high frequency drive (Treble). It employs high level crossover technique. The circuit performance was adequately verified and the frequency ...

  9. NMR studies of artificial double-crossover DNA tiles.

    Science.gov (United States)

    Veerapandian, Murugan; Kim, Byeonghoon; Amin, Rashid; Lee, Junwye; Yun, Kyusik; Park, Sung Ha

    2012-03-01

    This report documents the design and characterization of DNA molecular nanoarchitectures consisting of artificial double crossover DNA tiles with different geometry and chemistry. The Structural characterization of the unit tiles, including normal, biotinylated and hairpin loop structures, are morphologically studied by atomic force microscopy. The specific proton resonance of the individual tiles and their intra/inter nucleotide relationships are verified by proton nuclear magnetic resonance spectroscopy and 2-dimensional correlation spectral studies, respectively. Significant up-field and down-field shifts in the resonance signals of the individual residues at various temperatures are discussed. The results suggest that with artificially designed DNA tiles it is feasible to obtain structural information of the relative base sequences. These tiles were later fabricated into 2D DNA lattice structures for specific applications such as protein arrangement by biotinylated bulged loops or pattern generation using a hairpin structure.

  10. Multilevel data analysis of a crossover designed human nutritional intervention study

    NARCIS (Netherlands)

    van Velzen, E.J.J.; Westerhuis, J.A.; van Duynhoven, J.P.M.; van Dorsten, F.A.; Hoefsloot, H.C.J.; Jacobs, D.M.; Smit, S.; Draijer, R.; Kroner, C.I.; Smilde, A.K.

    2008-01-01

    A new method is introduced for the analysis of 'omics' data derived from crossover designed drug or nutritional intervention studies. The method aims at finding systematic variations in metabolic profiles after a drug or nutritional challenge and takes advantage of the crossover design in the data.

  11. Emergency cricothyrotomy: a randomised crossover trial comparing the wire-guided and catheter-over-needle techniques.

    NARCIS (Netherlands)

    Fikkers, B.G.; Vugt, S. van; Hoeven, J.G. van der; Hoogen, F.J.A. van den; Marres, H.A.M.

    2004-01-01

    In a randomised crossover trial, we compared a wire-guided cricothyrotomy technique (Minitrach) with a catheter-over-needle technique (Quicktrach). Performance time, ease of method, accuracy in placement and complication rate were compared. Ten anaesthesiology and 10 ENT residents performed

  12. A case-crossover study of transient risk factors influence on occupational injuries

    DEFF Research Database (Denmark)

    Oesterlund, Anna H; Lander, Flemming; Lauritsen, Jens

    2016-01-01

    , but so far no relevant research has been conducted in Europe. METHOD: Case-crossover studies of occupational injuries were collected from PubMed and Embase and read through. Previous experiences concerning method, exposure and outcome, time-related measurements and construction of the questionnaire were...... technique, change in working surroundings, using a phone, disagreement, feeling ill, being distracted and using malfunctioning machinery/tools or work material. Exposure time 'just before the injury' will be compared with two control periods, 'previous day at the same time of the injury' (pair match...

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

    Science.gov (United States)

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

    2015-05-01

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

  14. Study of pressure influence on thermal transition in spin-crossover nanomaterials

    National Research Council Canada - National Science Library

    Gudyma, Iurii V; Maksymov, Artur Iu; Ivashko, Victor V

    2014-01-01

    The thermal transition accompanied by the variation of the molecular volume in nanoparticles of spin-crossover materials has been studied on the basis of microscopic Ising-like model solved using Monte Carlo methods...

  15. Studies on Methanol Crossover in Liquid-Feed Direct Methanol Pem Fuel Cells

    Science.gov (United States)

    Narayanan, S. R.

    1995-01-01

    The performance of liquid feed direct methanol fuel cells using various types of Nafion membranes as the solid polymer electrolyte have been studied. The rate of fuel crossover and electrical performance has been measured for cells with Nafion membranes of various thicknesses and equivalent weights. The crossover rate is found to decrease with increasing thickness and applied current. The dependence of crossover rate on current density can be understood in terms of a simple linear diffusion model which suggests that the crossover rate can be influenced by the electrode structure in addition to the membrane. The studies suggest that Nafion EW 1500 is a very promising alternate to Nafion EW 1100 for direct methanol fuel cells.

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

    Science.gov (United States)

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

    2003-08-01

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

  17. Study of pressure influence on thermal transition in spin-crossover nanomaterials

    OpenAIRE

    Gudyma, Iurii V; Maksymov, Artur Iu; Ivashko, Victor V.

    2014-01-01

    The thermal transition accompanied by the variation of the molecular volume in nanoparticles of spin-crossover materials has been studied on the basis of microscopic Ising-like model solved using Monte Carlo methods. For considered model, we examined the spin-crossover phenomenon with applied hydrostatic pressure and thus was shown the possibility to shift transition temperature toward its room value. The obtained results of numerical simulations are in agreement with the experimental ones.

  18. Study of pressure influence on thermal transition in spin-crossover nanomaterials.

    Science.gov (United States)

    Gudyma, Iurii V; Maksymov, Artur Iu; Ivashko, Victor V

    2014-12-01

    The thermal transition accompanied by the variation of the molecular volume in nanoparticles of spin-crossover materials has been studied on the basis of microscopic Ising-like model solved using Monte Carlo methods. For considered model, we examined the spin-crossover phenomenon with applied hydrostatic pressure and thus was shown the possibility to shift transition temperature toward its room value. The obtained results of numerical simulations are in agreement with the experimental ones.

  19. Study of pressure influence on thermal transition in spin-crossover nanomaterials

    Science.gov (United States)

    Gudyma, Iurii V.; Maksymov, Artur Iu; Ivashko, Victor V.

    2014-12-01

    The thermal transition accompanied by the variation of the molecular volume in nanoparticles of spin-crossover materials has been studied on the basis of microscopic Ising-like model solved using Monte Carlo methods. For considered model, we examined the spin-crossover phenomenon with applied hydrostatic pressure and thus was shown the possibility to shift transition temperature toward its room value. The obtained results of numerical simulations are in agreement with the experimental ones.

  20. Cross-Over Study Comparing Postprandial Glycemic Increase After Addition of a Fixed-Dose Mitiglinide/Voglibose Combination or a Dipeptidyl Peptidase-4 Inhibitor to Basal Insulin Therapy in Patients with Type 2 Diabetes Mellitus.

    Science.gov (United States)

    Ihana-Sugiyama, Noriko; Yamamoto-Honda, Ritsuko; Sugiyama, Takehiro; Tsujimoto, Tetsuro; Kakei, Masafumi; Noda, Mitsuhiko

    2017-02-28

    BACKGROUND Although the efficacy of combination therapy consisting of basal insulin and oral hypoglycemic agents (OHAs) has been shown, which OHAs are the most efficient remains unclear. MATERIAL AND METHODS Five patients with type 2 diabetes were enrolled and treated with insulin degludec and metformin as a basal therapy. The patients were randomized in a cross-over fashion to receive a combination of mitiglinide (10 mg) and voglibose (0.2 mg) (M+V) 3 times daily or linagliptin (5 mg) (L) once daily for 8 weeks. After 8 weeks, 2 kinds of meal tolerance tests were performed as breakfast on 2 consecutive days. The first breakfast contained 460 kcal (carbohydrates, 49.1%; protein, 15.7%; fat, 35.2%), while the second contained 462 kcal (carbohydrates, 37.2%; protein, 19.6%; fat, 43.2%). Self-monitoring blood glucose levels were measured at 0, 30, 60, and 120 min after the meal tests, and the increase in the postprandial area under the curve (AUC)0-120 min was determined. The HbA1c, glycated albumin, and 1,5-anhydroglucitol (AG) levels were measured, and continuous glucose monitoring was performed. RESULTS The increase in the postprandial AUC0-120 min was significantly smaller in the M+V group than in the L group after both meals. The 24-h average, 24-h standard deviations, 24-h AUC, and mean amplitude of glycemic excursion (MAGE) were similar for both groups and after both meals. The change in 1,5-AG was higher in the M+V group than in the L group. CONCLUSIONS The combination of M+V with basal therapy improved postprandial glucose excursion more effectively than L in T2DM patients.

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

    OpenAIRE

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

    2009-01-01

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

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

    Science.gov (United States)

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

    2017-11-30

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

  3. Effect of zonisamide on essential tremor: a pilot crossover study in comparison with arotinolol.

    Science.gov (United States)

    Morita, Shuhei; Miwa, Hideto; Kondo, Tomoyoshi

    2005-03-01

    We performed a pilot, crossover trial of zonisamide (ZNS) on essential tremor patients. Patients were randomly selected to start either ZNS or arotinolol treatment for 2 weeks. After a washout period, the patients were switched to an alternative drug. The assessment of tremor was carried out using the Fahn-Tolosa-Marin's clinical rating scale for tremor at baseline and 2 weeks after administration of each drug. There was a significant improvement after ZNS and arotinolol administration compared with the baseline. There was no significant difference in the antitremor effect between ZNS and arotinolol; however, ZNS was more effective for tremors of cranial nerve areas. Although the number of enrolled patients was limited in the present study, this open-label pilot study suggests that ZNS may have a therapeutic potential for essential tremor. A controlled trial of this drug in the future would be valuable.

  4. Crossover design and its application in late-phase diabetes studies.

    Science.gov (United States)

    Wang, Tao; Malone, James; Fu, Haoda; Heilmann, Cory; Qu, Yongming; Huster, William J

    2016-09-01

    Crossover design has been widely used in late-phase clinical studies, as well as in pharmacokinetic and pharmacodynamic, bioequivalence, and medical device studies; however, its interpretability and applicability continue to be debated. Herein we provide discussions around a crossover design's scientific benefit, applicability, and how it can be implemented in late-phase diabetes studies by properly handling key issues: carryover effect, washout period, and baseline selection. Specifically, detailed considerations are provided about the validity and situations of having appropriate length of study duration to deal with carryover effects so that a washout period may not be needed. A simulation study and data mining results on 12 crossover late-phase insulin clinical trials are presented to examine the discussion points and proposals. © 2016 The Authors. Journal of Diabetes published by John Wiley & Sons Australia, Ltd and Ruijin Hospital, Shanghai Jiaotong University School of Medicine.

  5. Use of a fixed combination of acetylsalicylic acid, acetaminophen and caffeine compared with acetaminophen alone in episodic tension-type headache: meta-analysis of four randomized, double-blind, placebo-controlled, crossover studies

    Science.gov (United States)

    2014-01-01

    Background Most patients with episodic tension-type headache treat headache episodes with over-the-counter medication. Combination analgesics containing caffeine may be more effective and as well tolerated as monotherapy. The aim of this study was to evaluate the efficacy of the combination of acetylsalicylic acid, acetaminophen (paracetamol) and caffeine in episodic tension-type headache using recently recommended endpoints. Methods Four randomized, controlled trials of identical design in 1,900 patients with episodic tension-type headache comparing acetylsalicylic acid, acetaminophen and caffeine vs. acetaminophen or placebo were pooled. Analysis populations were ‘all headache episodes’ and those with ‘severe pain at baseline’. Post-hoc defined primary endpoint: headache episodes pain-free at 2 h. Secondary endpoints: headache episodes pain-free at 1 h, headache response at 2 h (mild or no pain), degree of interference with daily activities. Results 6,861 headache episodes were treated, including 2,215 severe headache episodes. The proportion of headache episodes pain-free at 2 h was significantly higher with the triple combination (28.5%) vs. acetaminophen (21.0%) and placebo (18.0%) (p pain-free at 2 h, headache response at 2 h and ability to return to daily activities, even in those with pain rated severe at baseline. PMID:25406671

  6. Comparing the effects of infrastructure on bicycling injury at intersections and non-intersections using a case-crossover design.

    Science.gov (United States)

    Harris, M Anne; Reynolds, Conor C O; Winters, Meghan; Cripton, Peter A; Shen, Hui; Chipman, Mary L; Cusimano, Michael D; Babul, Shelina; Brubacher, Jeffrey R; Friedman, Steven M; Hunte, Garth; Monro, Melody; Vernich, Lee; Teschke, Kay

    2013-10-01

    This study examined the impact of transportation infrastructure at intersection and non-intersection locations on bicycling injury risk. In Vancouver and Toronto, we studied adult cyclists who were injured and treated at a hospital emergency department. A case-crossover design compared the infrastructure of injury and control sites within each injured bicyclist's route. Intersection injury sites (N=210) were compared to randomly selected intersection control sites (N=272). Non-intersection injury sites (N=478) were compared to randomly selected non-intersection control sites (N=801). At intersections, the types of routes meeting and the intersection design influenced safety. Intersections of two local streets (no demarcated traffic lanes) had approximately one-fifth the risk (adjusted OR 0.19, 95% CI 0.05 to 0.66) of intersections of two major streets (more than two traffic lanes). Motor vehicle speeds less than 30 km/h also reduced risk (adjusted OR 0.52, 95% CI 0.29 to 0.92). Traffic circles (small roundabouts) on local streets increased the risk of these otherwise safe intersections (adjusted OR 7.98, 95% CI 1.79 to 35.6). At non-intersection locations, very low risks were found for cycle tracks (bike lanes physically separated from motor vehicle traffic; adjusted OR 0.05, 95% CI 0.01 to 0.59) and local streets with diverters that reduce motor vehicle traffic (adjusted OR 0.04, 95% CI 0.003 to 0.60). Downhill grades increased risks at both intersections and non-intersections. These results provide guidance for transportation planners and engineers: at local street intersections, traditional stops are safer than traffic circles, and at non-intersections, cycle tracks alongside major streets and traffic diversion from local streets are safer than no bicycle infrastructure.

  7. Comparing the effects of infrastructure on bicycling injury at intersections and non-intersections using a case–crossover design

    Science.gov (United States)

    Harris, M Anne; Reynolds, Conor C O; Winters, Meghan; Cripton, Peter A; Shen, Hui; Chipman, Mary L; Cusimano, Michael D; Babul, Shelina; Brubacher, Jeffrey R; Friedman, Steven M; Hunte, Garth; Monro, Melody; Vernich, Lee; Teschke, Kay

    2013-01-01

    Background This study examined the impact of transportation infrastructure at intersection and non-intersection locations on bicycling injury risk. Methods In Vancouver and Toronto, we studied adult cyclists who were injured and treated at a hospital emergency department. A case–crossover design compared the infrastructure of injury and control sites within each injured bicyclist's route. Intersection injury sites (N=210) were compared to randomly selected intersection control sites (N=272). Non-intersection injury sites (N=478) were compared to randomly selected non-intersection control sites (N=801). Results At intersections, the types of routes meeting and the intersection design influenced safety. Intersections of two local streets (no demarcated traffic lanes) had approximately one-fifth the risk (adjusted OR 0.19, 95% CI 0.05 to 0.66) of intersections of two major streets (more than two traffic lanes). Motor vehicle speeds less than 30 km/h also reduced risk (adjusted OR 0.52, 95% CI 0.29 to 0.92). Traffic circles (small roundabouts) on local streets increased the risk of these otherwise safe intersections (adjusted OR 7.98, 95% CI 1.79 to 35.6). At non-intersection locations, very low risks were found for cycle tracks (bike lanes physically separated from motor vehicle traffic; adjusted OR 0.05, 95% CI 0.01 to 0.59) and local streets with diverters that reduce motor vehicle traffic (adjusted OR 0.04, 95% CI 0.003 to 0.60). Downhill grades increased risks at both intersections and non-intersections. Conclusions These results provide guidance for transportation planners and engineers: at local street intersections, traditional stops are safer than traffic circles, and at non-intersections, cycle tracks alongside major streets and traffic diversion from local streets are safer than no bicycle infrastructure. PMID:23411678

  8. Theoretical study of hysteresis in electron transport through spin-crossover molecules

    Science.gov (United States)

    Brown, Kristen; Park, Kyungwha

    2012-02-01

    Recent advances in nanoscale molecular systems stimulate experimental studies of electron transport across molecular junctions formed by single molecules or nanoparticles bridged between electrodes, or molecular monolayers adsorbed onto surfaces, using three-terminal set-ups or scanning tunneling microscope. Among them, spin-crossover molecular systems draw attention due to their unusual coupling between spin degrees of freedom and external stimuli. Spin magnetic moments of these molecular systems increase with increasing temperature or pressure, or shining light, and their magnetization shows hysteresis behavior with temperature, pressure, or light. Recent transport measurements across nanoparticles made of such spin-crossover molecules reveal hysteresis behavior in current-voltage characteristics, driven by voltage at a given temperature. In this talk, we present our work on understanding of hysteresis in electron transport through a nanoparticle consisting of Fe-based spin-crossover molecules, using a model-Hamiltonian approach and insight obtained from density functional theory.

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

    NARCIS (Netherlands)

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

    2005-01-01

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

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

    Science.gov (United States)

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

    2017-08-01

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

  11. An open label, randomized, fixed-dose, crossover study comparing efficacy and safety of sildenafil citrate and saffron (Crocus sativus Linn.) for treating erectile dysfunction in men naïve to treatment.

    Science.gov (United States)

    Safarinejad, M R; Shafiei, N; Safarinejad, S

    2010-01-01

    Saffron (Crocus sativus Linn.) have been perceived by the public as a strong aphrodisiac herbal product. However, studies addressing the potential beneficial effects of saffron on erectile function (EF) in men with ED are lacking. Our aim was to evaluate the efficacy and safety of saffron administration on EF in men with ED. After a 4-week baseline assessment, 346 men with ED (mean age 46.6+/-8.4 years) were randomized to receive on-demand sildenafil for 12 weeks followed by 30 mg saffron twice daily for another 12 weeks or vice versa, separated by a 2-week washout period. To determine the type of ED, penile color duplex Doppler ultrasonography before and after intracavernosal injection with 20 microg prostaglandin E(1), pudendal nerve conduction tests and impaired sensory-evoked potential studies were performed. Subjects were assessed with an International Index of Erectile Function (IIEF) questionnaire, Sexual Encounter Profile (SEP) diary questions, patient and partner versions of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire and the Global Efficacy Question (GEQ) 'Has the medication you have been taking improved your erections?' No significant improvements were observed with regard to the IIEF sexual function domains, SEP questions and EDITS scores with saffron administration. The mean changes from baseline values in IIEF-EF domain were +87.6% and +9.8% in sildenafil and placebo groups, respectively (P=0.08). We did not observe any improvement in 15 individual IIEF questions in patients while taking saffron. Treatment satisfaction as assessed by partner versions of EDITS was found to be very low in saffron patients (72.4 vs 25.4, P=0.001). Mean per patient 'yes' responses to GEQ was 91.2 and 4.2% for sildenafil and saffron, respectively (P=0.0001). These findings do not support a beneficial effect of saffron administration in men with ED.

  12. Performance study of a double crossover for facing and trailing directions

    NARCIS (Netherlands)

    Liu, X.; Markine, V.L.; Shevtsov, I.

    2015-01-01

    This paper presented the performance study of two frogs in a double crossover in the railway network in the Netherlands. These frogs are located on the same track line. Each train passes through Frog 1 in the facing direction and Frog 2 in the trailing direction. Both frogs are monitored with ESAH-M

  13. Cognitive-behavioural approaches in the treatment of hypochondriasis : six single case cross-over studies

    NARCIS (Netherlands)

    Bouman, Theo; Visser, S.

    This study evaluates a cognitive and a behavioural treatment protocol for hypochondriacal complaints. In a cross-over design, six patients with a primary diagnosis of hypochondriasis were treated. Three of them first received a block of behavioural therapy (exposure in vivo and response prevention),

  14. Gastric acid control with esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole: a five-way crossover study.

    Science.gov (United States)

    Miner, Philip; Katz, Philip O; Chen, Yusong; Sostek, Mark

    2003-12-01

    Proton pump inhibitors owe their clinical efficacy to their ability to suppress gastric acid production. The objective of this study was to evaluate and compare intragastric pH following standard doses of esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole. This randomized, open-label, comparative five-way crossover study evaluated the 24-h intragastric pH profile of oral esomeprazole 40 mg, lansoprazole 30 mg, omeprazole 20 mg, pantoprazole 40 mg, and rabeprazole 20 mg once daily in 34 Helicobacter pylori-negative patients aged 18-60 yr with symptoms of gastroesophageal reflux disease. Patients were randomly assigned to one of five treatment sequences and study drug was taken on 5 consecutive mornings 30 minutes prior to a standardized breakfast. A washout period of at least 10 days separated each treatment phase. Thirty-four patients provided evaluable data for all five comparators. The mean number of hours of evaluable pH data was > or =23.75 hours. On day 5, intragastric pH was maintained above 4.0 for a mean of 14.0 h with esomeprazole, 12.1 h with rabeprazole, 11.8 h with omeprazole, 11.5 h with lansoprazole, and 10.1 h with pantoprazole (p omeprazole, pantoprazole, and rabeprazole in patients with symptoms of gastroesophageal reflux disease.

  15. Aspartame sensitivity? A double blind randomised crossover study.

    Directory of Open Access Journals (Sweden)

    Thozhukat Sathyapalan

    Full Text Available Aspartame is a commonly used intense artificial sweetener, being approximately 200 times sweeter than sucrose. There have been concerns over aspartame since approval in the 1980s including a large anecdotal database reporting severe symptoms. The objective of this study was to compare the acute symptom effects of aspartame to a control preparation.This was a double-blind randomized cross over study conducted in a clinical research unit in United Kingdom. Forty-eight individual who has self reported sensitivity to aspartame were compared to 48 age and gender matched aspartame non-sensitive individuals. They were given aspartame (100mg-containing or control snack bars randomly at least 7 days apart. The main outcome measures were acute effects of aspartame measured using repeated ratings of 14 symptoms, biochemistry and metabonomics.Aspartame sensitive and non-sensitive participants differed psychologically at baseline in handling feelings and perceived stress. Sensitive participants had higher triglycerides (2.05 ± 1.44 vs. 1.26 ± 0.84mmol/L; p value 0.008 and lower HDL-C (1.16 ± 0.34 vs. 1.35 ± 0.54 mmol/L; p value 0.04, reflected in 1H NMR serum analysis that showed differences in the baseline lipid content between the two groups. Urine metabonomic studies showed no significant differences. None of the rated symptoms differed between aspartame and control bars, or between sensitive and control participants. However, aspartame sensitive participants rated more symptoms particularly in the first test session, whether this was placebo or control. Aspartame and control bars affected GLP-1, GIP, tyrosine and phenylalanine levels equally in both aspartame sensitive and non-sensitive subjects.Using a comprehensive battery of psychological tests, biochemistry and state of the art metabonomics there was no evidence of any acute adverse responses to aspartame. This independent study gives reassurance to both regulatory bodies and the public that

  16. 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

  17. Investigation of the hemostatic effect of a transdermal patch containing 0.55 mg ethinyl estradiol and 2.1 mg gestodene compared with a monophasic oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel: an open-label, randomized, crossover study.

    Science.gov (United States)

    Junge, Wolfgang; Heger-Mahn, Doris; Trummer, Dietmar; Merz, Martin

    2013-09-01

    Transdermal delivery of contraceptives offers several advantages over combined oral contraceptives (COCs), including effective absorption and the provision of relatively constant serum concentrations. Ethinyl estradiol (EE) and the progestin gestodene are well-absorbed through the skin and, therefore, well-suited for use in a transdermal contraceptive patch. The objective of this study was to investigate the impact of a once-weekly transparent, transdermal patch delivering low doses of EE and gestodene equivalent to a COC containing 0.02 mg EE and 0.06 mg gestodene on hemostasis parameters compared with a monophasic COC containing 0.03 mg EE and 0.15 mg levonorgestrel. In this single-center, open-label, randomized, crossover study, 30 women (aged 18-35 years) received three cycles of each treatment, separated by a two-cycle washout period. The primary outcome measure was the absolute change from baseline in prothrombin fragments 1 + 2 and D-dimer. For both treatments, prothrombin fragments 1 + 2 remained stable during the first treatment period, and increased only slightly in the second period (mean absolute change 0.025 and 0.028 nmol/L in the novel Bayer patch and COC groups, respectively). Increases in D-dimer were observed in both periods (mean absolute change 107.0 ± 147.2 ng/L for the novel Bayer patch and 113.7 ± 159.0 ng/L for the COC). There were no statistically significant treatment differences in prothrombin 1 + 2 or D-dimer (p = 0.667 and p = 0.884, respectively) and no statistically significant treatment sequence or period effects. A COC containing 0.03 mg EE and 0.15 mg levonorgestrel and the novel Bayer patch have comparable influence on hemostatic endpoints. Both treatments were well-tolerated by subjects.

  18. The Efficacy of LUCAS in Prehospital Cardiac Arrest Scenarios: A Crossover Mannequin Study

    Science.gov (United States)

    Gyory, Robert A.; Buchle, Scott E.; Rodgers, David; Lubin, Jeffrey S.

    2017-01-01

    Introduction High-quality cardiopulmonary resuscitation (CPR) is critical for successful cardiac arrest outcomes. Mechanical devices may improve CPR quality. We simulated a prehospital cardiac arrest, including patient transport, and compared the performance of the LUCAS™ device, a mechanical chest compression-decompression system, to manual CPR. We hypothesized that because of the movement involved in transporting the patient, LUCAS would provide chest compressions more consistent with high-quality CPR guidelines. Methods We performed a crossover-controlled study in which a recording mannequin was placed on the second floor of a building. An emergency medical services (EMS) crew responded, defibrillated, and provided either manual or LUCAS CPR. The team transported the mannequin through hallways and down stairs to an ambulance and drove to the hospital with CPR in progress. Critical events were manually timed while the mannequin recorded data on compressions. Results Twenty-three EMS providers participated. Median time to defibrillation was not different for LUCAS compared to manual CPR (p=0.97). LUCAS had a lower median number of compressions per minute (112/min vs. 125/min; IQR = 102–128 and 102–126 respectively; pprehospital cardiac arrest patient. PMID:28435494

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

    Science.gov (United States)

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

    2016-11-01

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

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

    Directory of Open Access Journals (Sweden)

    Quinn Stephen

    2009-10-01

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

  1. 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.

  2. 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

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

    OpenAIRE

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

    2016-01-01

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

  4. Personal smartphones for neonatal diagnostic imaging: A prospective crossover study.

    Science.gov (United States)

    Westberg, Margreta; Vasko, Theresia; Owen, Louise S; Bhatia, Risha; Lluch, Marta Thio; Donath, Susan; Davis, Peter G; Dawson, Jennifer A

    2017-04-01

    Neonatal clinicians may be asked to review X-ray images when unable to directly access the original image. Transmitting an X-ray image to a smartphone is a technique increasingly being used by clinicians in a number of settings. Minimal data exist on its use in the neonatal setting. Our aim was to compare the ability of neonatal clinicians to correctly diagnose a pneumothorax from a chest radiograph (CXR) viewed on a smartphone, paralleled with the same image viewed on a computer screen. We investigated the accuracy, sensitivity, specificity, positive predictive value and negative predicative value of two methods of viewing CXR images to diagnose pneumothorax, compared with a gold standard radiologist report. Clinicians were presented with 40 CXR images on two occasions, at least 1 week apart. Images were viewed once on a smartphone and once on a computer screen. Both the viewing method and viewing order of the images were randomised. The clinical details of the infant at the time the CXR was taken were provided, and participants were asked if a pneumothorax was present. Twenty-one clinicians viewed all CXR images using both viewing methods (840 paired observations). There was no difference in accuracy of detecting pneumothorax between viewing methods, 81% correctly identified a pneumothorax using the smartphone, versus 80% using the computer screen (P = 0.40 (95% CI), difference -4 to 1.5%). Diagnosis of neonatal pneumothorax was as accurate using a smartphone as viewing CXR images displayed on a computer screen when clinicians were presented with X-rays with diagnosis of pneumothorax. © 2017 Paediatrics and Child Health Division (The Royal Australasian College of Physicians).

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

    NARCIS (Netherlands)

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

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

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

    Science.gov (United States)

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

    2012-08-01

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

  7. The VEPRO trial: A cross-over randomised controlled trial comparing 2 progressive lenses for patients with presbyopia

    Directory of Open Access Journals (Sweden)

    Boutron Isabelle

    2008-09-01

    Full Text Available Abstract Background The aim of this trial was to compare the effectiveness of two generations of progressive lenses for presbyopia. Methods A multicenter cross-over randomized controlled trial performed in a primary care setting (5 optical dispensaries was planned. Two categories of progressive lenses were compared: 1 a new-generation lens (i.e., VARILUX PANAMIC ORMA CRIZAL, which is expensive but a supposed improvement in comfort, and 2 an older-generation lens (i.e., VARILUX CONFORT ORMA CRIZAL, which is less expensive and is considered the reference lens. Patients were randomized to wear one generation of progressive lens for 4 weeks, then cross over to wear the other lens for 4 weeks, without knowing the sequence of lenses. Inclusion criteria were 1 age 43–60 years; 2 outpatients already wearing progressive lenses and referred to an optician ophthalmologist for optical correction prescription within the last 6 months; 3 receiving a correction of ≤3 dioptres in cases of associated myopia, hyperopia or astigmatism; 4 understanding and speaking French and able to answer a questionnaire; and 5 giving written consent to participate in the study. The primary outcome was patient preference for one progressive lens at week 8. Secondary outcomes were subjective measures of bifocal visual performance, including a near visual acuity, b visual field, c kinetic visual skills, d visual adaptability, e visual comfort, and f rapidity of adaptation. Results 127 patients were randomized to one of the lens groups. Two patients withdrew prematurely; 98.4% and 97.6% patients who wore the new versus older lenses, respectively, wore their progressive lenses every day during the 4-week period 1 and period 2. The number of participants in each of 5 centres varied from 16 (12.6% to 35 (27.6%. 57.9% patients preferred the new-generation lenses, 36.5% the older-generation lenses, and 5.6% had no preference (p = 0.01. The two groups did not differ in any of the

  8. The VEPRO trial: a cross-over randomised controlled trial comparing 2 progressive lenses for patients with presbyopia.

    Science.gov (United States)

    Boutron, Isabelle; Touizer, Caroline; Pitrou, Isabelle; Roy, Carine; Ravaud, Philippe

    2008-09-19

    The aim of this trial was to compare the effectiveness of two generations of progressive lenses for presbyopia. A multicenter cross-over randomized controlled trial performed in a primary care setting (5 optical dispensaries) was planned. Two categories of progressive lenses were compared: 1) a new-generation lens (i.e., VARILUX PANAMIC ORMA CRIZAL), which is expensive but a supposed improvement in comfort, and 2) an older-generation lens (i.e., VARILUX CONFORT ORMA CRIZAL), which is less expensive and is considered the reference lens. Patients were randomized to wear one generation of progressive lens for 4 weeks, then cross over to wear the other lens for 4 weeks, without knowing the sequence of lenses. Inclusion criteria were 1) age 43-60 years; 2) outpatients already wearing progressive lenses and referred to an optician ophthalmologist for optical correction prescription within the last 6 months; 3) receiving a correction of study.The primary outcome was patient preference for one progressive lens at week 8. Secondary outcomes were subjective measures of bifocal visual performance, including a) near visual acuity, b) visual field, c) kinetic visual skills, d) visual adaptability, e) visual comfort, and f) rapidity of adaptation. 127 patients were randomized to one of the lens groups. Two patients withdrew prematurely; 98.4% and 97.6% patients who wore the new versus older lenses, respectively, wore their progressive lenses every day during the 4-week period 1 and period 2. The number of participants in each of 5 centres varied from 16 (12.6%) to 35 (27.6%).57.9% patients preferred the new-generation lenses, 36.5% the older-generation lenses, and 5.6% had no preference (p = 0.01). The two groups did not differ in any of the measures of bifocal visual performance except

  9. Effect of lanthanum carbonate vs. calcium carbonate on serum calcium in hemodialysis patients: a crossover study.

    Science.gov (United States)

    Toida, Tatsunori; Fukudome, Keiichi; Fujimoto, Shouichi; Yamada, Kazuhiro; Sato, Yuji; Chiyotanda, Susumu; Kitamura, Kazuo

    2012-09-01

    Lanthanum carbonate (LC) is a non-calcium-containing phosphate binder and shows a comparable effect with other phosphate binders on hyperphosphatemia in dialysis patients. LC also contributes to a reduced oral calcium load compared with calcium carbonate (CaC) treatment. However, no crossover studies which compare the influence on serum calcium level between treatments with LC and CaC in hemodialysis (HD) patients have been carried out. After washout for 2 weeks, 50 patients on HD were randomized (1 : 1) to receive LC or CaC for 3 months. Thereafter, patients underwent a second 2-week washout period and were switched to the alternative binder for the next 3 months. Mineral and bone metabolism markers were measured with the changes of vitamin D doses. The serum phosphate level showed a similar decrease from baseline to 3 months in both groups. During the study periods, hypercalcemia was observed only in patients taking CaC. The dose of vitamin D analogue was increased more frequently in the patients of the LC group compared with LC group. The iPTH level showed a significant decrease in the CaC group, but not in the LC group. Serum levels of BAP, TRAP5b, and ALP were significantly elevated in the LC group, whereas the FGF-23 level showed a significant decrease. LC effectively reduced the serum phosphate level (like CaC) and allowed the vitamin D analogue dosage to be increased without hypercalcemia in HD patients. LC is one of the useful phosphate binders without hypercalcemia. (UMIN-CTR registration number: UMIN000002331).

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

    Directory of Open Access Journals (Sweden)

    Shankaranarayanan Jeykodi

    2016-01-01

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

  11. Cross-over studies underestimate energy compensation: The example of sucrose-versus sucralose-containing drinks.

    Science.gov (United States)

    Gadah, Nouf S; Brunstrom, Jeffrey M; Rogers, Peter J

    2016-12-01

    The vast majority of preload-test-meal studies that have investigated the effects on energy intake of disguised nutrient or other food/drink ingredient manipulations have used a cross-over design. We argue that this design may underestimate the effect of the manipulation due to carry-over effects. To test this we conducted comparable cross-over (n = 69) and parallel-groups (n = 48) studies testing the effects of sucrose versus low-calorie sweetener (sucralose) in a drink preload on test-meal energy intake. The parallel-groups study included a baseline day in which only the test meal was consumed. Energy intake in that meal was used to control for individual differences in energy intake in the analysis of the effects of sucrose versus sucralose on energy intake on the test day. Consistent with our prediction, the effect of consuming sucrose on subsequent energy intake was greater when measured in the parallel-groups study than in the cross-over study (respectively 64% versus 36% compensation for the 162 kcal difference in energy content of the sucrose and sucralose drinks). We also included a water comparison group in the parallel-groups study (n = 24) and found that test-meal energy intake did not differ significantly between the water and sucralose conditions. Together, these results confirm that consumption of sucrose in a drink reduces subsequent energy intake, but by less than the energy content of the drink, whilst drink sweetness does not increase food energy intake. Crucially, though, the studies demonstrate that study design affects estimated energy compensation. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

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

    Science.gov (United States)

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

    2013-09-01

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

  13. Acute Low Back Pain? Do Not Blame the Weather-A Case-Crossover Study.

    Science.gov (United States)

    Beilken, Keira; Hancock, Mark J; Maher, Chris G; Li, Qiang; Steffens, Daniel

    2017-06-01

    To investigate the influence of various weather parameters on the risk of developing a low back pain (LBP) episode. Case-crossover study. Primary care clinics in Sydney, Australia. 981 participants with a new episode of acute LBP. Weather parameters were obtained from the Australian Bureau of Meteorology. Odds ratios (OR) and 95% confidence intervals (95% CI) were derived comparing two exposure variables in the case window-(1) the average of the weather variable for the day prior to pain onset and (2) the change in the weather variable from 2 days prior to 1 day prior to pain onset-with exposures in two control windows (1 week and 1 month before the case window). The weather parameters of precipitation, humidity, wind speed, wind gust, wind direction, and air pressure were not associated with the onset of acute LBP. For one of the four analyses, higher temperature slightly increased the odds of pain onset. Common weather parameters that had been previously linked to musculoskeletal pain, such as precipitation, humidity, wind speed, wind gust, wind direction, and air pressure, do not increase the risk of onset for LBP.

  14. Theoretical study of the crossover into hydrodynamic regime in graphene

    Science.gov (United States)

    Ho, Derek; Yudhistira, Indra; Hu, Ben Yu-Kuang; Adam, Shaffique

    Experiments on graphene have recently succeeded in entering the hydrodynamic regime, as demonstrated by successful observations of strong violation of Wiedemann-Franz law, the Gurzhi effect and electronic Poiseuille flow. It is known that electronic systems enter the hydrodynamic regime when electron-electron scattering dominates over electron-impurity and electron-phonon scattering. However, a quantitative study of this transition from the Fermi liquid to hydrodynamic regime is still lacking. In view of this, we quantitatively analyze the electron-electron, electron-impurity and electron-phonon scattering rates as a function of temperature, charge doping and disorder (charge puddle) strength. This yields a quantitative understanding of the onset of hydrodynamic electronic behavior in graphene samples. This work is supported by the National Research Foundation of Singapore under its Fellowship program (NRF-NRFF2012-01) and by the Singapore Ministry of Education and Yale-NUS College through Grant No. R-607-265-01312.

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

    Science.gov (United States)

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

    2003-01-01

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

  16. 360° Operative Videos: A Randomised Cross-Over Study Evaluating Attentiveness and Information Retention.

    Science.gov (United States)

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

    2017-11-06

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

  17. Effect of bread gluten content on gastrointestinal function: a crossover MRI study on healthy humans.

    Science.gov (United States)

    Coletta, Marina; Gates, Fred K; Marciani, Luca; Shiwani, Henna; Major, Giles; Hoad, Caroline L; Chaddock, Gemma; Gowland, Penny A; Spiller, Robin C

    2016-01-14

    Gluten is a crucial functional component of bread, but the effect of increasing gluten content on gastrointestinal (GI) function remains uncertain. Our aim was to investigate the effect of increasing gluten content on GI function and symptoms in healthy participants using the unique capabilities of MRI. A total of twelve healthy participants completed this randomised, mechanistic, open-label, three-way crossover study. On days 1 and 2 they consumed either gluten-free bread (GFB), or normal gluten content bread (NGCB) or added gluten content bread (AGCB). The same bread was consumed on day 3, and MRI scans were performed every 60 min from fasting baseline up to 360 min after eating. The appearance of the gastric chime in the images was assessed using a visual heterogeneity score. Gastric volumes, the small bowel water content (SBWC), colonic volumes and colonic gas content and GI symptoms were measured. Fasting transverse colonic volume after the 2-d preload was significantly higher after GFB compared with NGCB and AGCB with a dose-dependent response (289 (SEM 96) v. 212 (SEM 74) v. 179 (SEM 87) ml, respectively; P=0·02). The intragastric chyme heterogeneity score was higher for the bread with increased gluten (AGCB 6 (interquartile range (IQR) 0·5) compared with GFB 3 (IQR 0·5); P=0·003). However, gastric half-emptying time was not different between breads nor were study day GI symptoms, postprandial SBWC, colonic volume and gas content. This MRI study showed novel mechanistic insights in the GI responses to different breads, which are poorly understood notwithstanding the importance of this staple food.

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

    Science.gov (United States)

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

    2017-03-15

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

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

    Science.gov (United States)

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

    2016-02-01

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

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

    Science.gov (United States)

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

    2011-01-01

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

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

    Science.gov (United States)

    Sørensen, L B; Astrup, A

    2011-12-05

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

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

    Science.gov (United States)

    Sørensen, L B; Astrup, A

    2011-01-01

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

  3. The antimicrobial efficacy of copper alloy furnishing in the clinical environment: a crossover study.

    Science.gov (United States)

    Karpanen, T J; Casey, A L; Lambert, P A; Cookson, B D; Nightingale, P; Miruszenko, L; Elliott, T S J

    2012-01-01

    To determine whether copper incorporated into hospital ward furnishings and equipment can reduce their surface microbial load. A crossover study. Acute care medical ward with 19 beds at a large university hospital. Fourteen types of frequent-touch items made of copper alloy were installed in various locations on an acute care medical ward. These included door handles and push plates, toilet seats and flush handles, grab rails, light switches and pull cord toggles, sockets, overbed tables, dressing trolleys, commodes, taps, and sink fittings. Their surfaces and those of equivalent standard items on the same ward were sampled once weekly for 24 weeks. The copper and standard items were switched over after 12 weeks of sampling to reduce bias in usage patterns. The total aerobic microbial counts and the presence of indicator microorganisms were determined. Eight of the 14 copper item types had microbial counts on their surfaces that were significantly lower than counts on standard materials. The other 6 copper item types had reduced microbial numbers on their surfaces, compared with microbial counts on standard items, but the reduction did not reach statistical significance. Indicator microorganisms were recovered from both types of surfaces; however, significantly fewer copper surfaces were contaminated with vancomycin-resistant enterococci, methicillin-susceptible Staphylococcus aureus, and coliforms, compared with standard surfaces. Copper alloys (greater than or equal to 58% copper), when incorporated into various hospital furnishings and fittings, reduce the surface microorganisms. The use of copper in combination with optimal infection-prevention strategies may therefore further reduce the risk that patients will acquire infection in healthcare environments.

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

    Science.gov (United States)

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

    2009-10-21

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

  5. Clinical features and risk factors for upper gastrointestinal bleeding in children: a case-crossover study.

    Science.gov (United States)

    Grimaldi-Bensouda, Lamiae; Abenhaim, Lucien; Michaud, Laurent; Mouterde, Olivier; Jonville-Béra, Annie Pierre; Giraudeau, Bruno; David, Benoît; Autret-Leca, Elisabeth

    2010-08-01

    This population-based survey was conducted to provide a formal description of upper gastrointestinal bleeding (UGIB) in children on a nationwide basis and assess the contribution of risk factors, principally nonsteroidal anti-inflammatory drugs (NSAID). A case-crossover study of UGIB patients aged between 2 months and 16 years was conducted in France. Medical data were collected by physicians, and personal risk factors and exposure to drugs during the month preceding the onset of the bleeding was ascertained by a standardised telephone interview with parents. The odds ratios for UGIB and NSAID was assessed by comparing exposure during the 7 days preceding the date of hospitalisation and the 21st to the 28th days before that date. A total of 177 children with UGIB were included over 2 years. Eighty-three children had taken at least one NSAID before the index date, among which 58 were ibuprofen, 26 aspirin and nine others. The adjusted odds ratio (OR) of exposure was 8.2 [95% confidence interval (CI) 2.6-26.0] for NSAIDs altogether, and this was 10.0 (95% CI 2.0-51.0) for ibuprofen and 7.3 (95% CI 0.9-59.4) for aspirin. There was no increased risk associated with NSAIDS for oesophageal lesion [OR = 1.0 [(5% CI:0.2-7.2)]. The study confirms that UGIB is rare but that some cases may be avoided, as one third of the cases was attributable to exposure to NSAID at doses used for analgesic or antipyretic purposes, which may be attained with alternative therapy. The findings from this study call for more caution in prescribing NSAIDS to children.

  6. The pharmacokinetics and safety of a fixed-dose combination of acetylsalicylic acid and clopidogrel compared with the concurrent administration of acetylsalicylic acid and clopidogrel in healthy subjects: a randomized, open-label, 2-sequence, 2-period, single-dose crossover study.

    Science.gov (United States)

    Jung, Jin Ah; Kim, Tae-Eun; Kim, Jung-Ryul; Kim, Min-Ji; Huh, Wooseong; Park, Kyung-Mi; Lee, Soo-Youn; Ko, Jae-Wook

    2013-07-01

    Dual antiplatelet therapy with clopidogrel plus acetylsalicylic acid (ASA) is used for the treatment of acute coronary syndrome. A combined formulation of ASA and clopidogrel has been developed to provide dosing convenience and improve adherence. This study was designed to compare the pharmacokinetic properties and safety profile of a fixed-dose combination formulation of ASA and clopidogrel with concurrent administration of each agent in healthy male Korean volunteers. This single-dose, randomized, open-label, 2-period crossover study was conducted in 64 healthy Korean volunteers. Equal numbers of eligible participants were randomly assigned to receive either the fixed-dose combination of ASA 100 mg and clopidogrel 75 mg or the free combination of each agent followed by a 7-day washout period and then administration of the alternate formulation. Serial blood samples were collected immediately before and after dosing for 24 hours. The safety profile was evaluated by using adverse events (AEs), which were assessed by physical examination, vital signs, ECGs, clinical laboratory tests, and interviews. The 2 formulations were considered to be bioequivalent if the 90% CIs for the log-transformed C(max) and AUC(0-last) values were within the predetermined range of 0.8 to 1.25. Sixty-four volunteers (mean [SD] age, 27.51 [8.15] years; weight, 68.55 [7.86] kg; height, 173.80 [5.94] cm) were enrolled, and 63 completed the study. For ASA, the 90% CIs for the geometric mean ratios of C(max) and AUC(0-last) were 0.9483 to 1.1717 and 0.9946 to 1.1020, respectively. For salicylic acid, the 90% CIs were 0.9614 to 1.0396 for C(max) and 0.9778 to 1.0163 for AUC(0-last). For clopidogrel, the 90% CIs were 0.9809 to 1.2562 for C(max) and 0.9674 to 1.2073 for AUC(0-last). Six of the 20 AEs reported were drug related: decreased hemoglobin levels (n = 2), fever (n = 1), and headache (n = 1) with the test formulation and increased alanine aminotransferase levels (n = 1) and dyspepsia (n

  7. Effect of sumatriptan on gastric emptying: A crossover study using the BreathID system

    Science.gov (United States)

    Sakamoto, Yasunari; Sekino, Yusuke; Yamada, Eiji; Higurashi, Takuma; Ohkubo, Hidenori; Sakai, Eiji; Endo, Hiroki; Iida, Hiroshi; Nonaka, Takashi; Fujita, Koji; Yoneda, Masato; Koide, Tomoko; Takahashi, Hirokazu; Goto, Ayumu; Abe, Yasunobu; Gotoh, Eiji; Maeda, Shin; Nakajima, Atsushi; Inamori, Masahiko

    2012-01-01

    AIM: To determine the effect of oral sumatriptan on gastric emptying using a continuous 13C breath test (BreathID system). METHODS: Ten healthy male volunteers participated in this randomized, 2-way crossover study. The subjects fasted overnight and were randomly assigned to receive a test meal (200 kcal/200 mL) 30 min after pre-medication with sumatriptan 50 mg (sumatriptan condition), or the test meal alone (control condition). Gastric emptying was monitored for 4 h after administration of the test meal by the 13C-acetic acid breath test performed continually using the BreathID system. Then, using Oridion Research Software (β version), the time taken for emptying of 50% of the labeled meal (T1/2) similar to the scintigraphy lag time for 10% emptying of the labeled meal (Tlag), the gastric emptying coefficient (GEC), and the regression-estimated constants (β and κ) were calculated. The statistical significance of any differences in the parameters were analyzed using Wilcoxon’s signed-rank test. RESULTS: In the sumatriptan condition, significant differences compared with the control condition were found in T1/2 [median 131.84 min (range, 103.13-168.70) vs 120.27 min (89.61-138.25); P = 0.0016], Tlag [median 80.085 min (59.23-125.89) vs 61.11 min (39.86-87.05); P = 0.0125], and β [median 2.3374 (1.6407-3.8209) vs 2.0847 (1.4755-2.9269); P = 0.0284]. There were no significant differences in the GEC or κ between the 2 conditions. CONCLUSION: This study showed that oral sumatriptan significantly delayed gastric emptying of a liquid meal. PMID:22807611

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

    Directory of Open Access Journals (Sweden)

    Lavinia Fiorentino

    2009-12-01

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

  9. Effects of tongue cleaning on bacterial flora in tongue coating and dental plaque: a crossover study.

    Science.gov (United States)

    Matsui, Miki; Chosa, Naoyuki; Shimoyama, Yu; Minami, Kentaro; Kimura, Shigenobu; Kishi, Mitsuo

    2014-01-14

    The effects of tongue cleaning on reconstruction of bacterial flora in dental plaque and tongue coating itself are obscure. We assessed changes in the amounts of total bacteria as well as Fusobacterium nucleatum in tongue coating and dental plaque specimens obtained with and without tongue cleaning. We conducted a randomized examiner-blind crossover study using 30 volunteers (average 23.7 ± 3.2 years old) without periodontitis. After dividing randomly into 2 groups, 1 group was instructed to clean the tongue, while the other did not. On days 1 (baseline), 3, and 10, tongue coating and dental plaque samples were collected after recording tongue coating score (Winkel tongue coating index: WTCI). After a washout period of 3 weeks, the same examinations were performed with the subjects allocated to the alternate group. Genomic DNA was purified from the samples and applied to SYBR® Green-based real-time PCR to quantify the amounts of total bacteria and F. nucleatum. After 3 days, the WTCI score recovered to baseline, though the amount of total bacteria in tongue coating was significantly lower as compared to the baseline. In plaque samples, the bacterial amounts on day 3 and 10 were significantly lower than the baseline with and without tongue cleaning. Principal component analysis showed that variations of bacterial amounts in the tongue coating and dental plaque samples were independent from each other. Furthermore, we found a strong association between amounts of total bacteria and F. nucleatum in specimens both. Tongue cleaning reduced the amount of bacteria in tongue coating. However, the cleaning had no obvious contribution to inhibit dental plaque formation. Furthermore, recovery of the total bacterial amount induced an increase in F. nucleatum in both tongue coating and dental plaque. Thus, it is recommended that tongue cleaning and tooth brushing should both be performed for promoting oral health.

  10. Crossover versus mutation: a comparative analysis of the evolutionary strategy of genetic algorithms applied to combinatorial optimization problems.

    Science.gov (United States)

    Osaba, E; Carballedo, R; Diaz, F; Onieva, E; de la Iglesia, I; Perallos, A

    2014-01-01

    Since their first formulation, genetic algorithms (GAs) have been one of the most widely used techniques to solve combinatorial optimization problems. The basic structure of the GAs is known by the scientific community, and thanks to their easy application and good performance, GAs are the focus of a lot of research works annually. Although throughout history there have been many studies analyzing various concepts of GAs, in the literature there are few studies that analyze objectively the influence of using blind crossover operators for combinatorial optimization problems. For this reason, in this paper a deep study on the influence of using them is conducted. The study is based on a comparison of nine techniques applied to four well-known combinatorial optimization problems. Six of the techniques are GAs with different configurations, and the remaining three are evolutionary algorithms that focus exclusively on the mutation process. Finally, to perform a reliable comparison of these results, a statistical study of them is made, performing the normal distribution z-test.

  11. Crossover versus Mutation: A Comparative Analysis of the Evolutionary Strategy of Genetic Algorithms Applied to Combinatorial Optimization Problems

    Directory of Open Access Journals (Sweden)

    E. Osaba

    2014-01-01

    Full Text Available Since their first formulation, genetic algorithms (GAs have been one of the most widely used techniques to solve combinatorial optimization problems. The basic structure of the GAs is known by the scientific community, and thanks to their easy application and good performance, GAs are the focus of a lot of research works annually. Although throughout history there have been many studies analyzing various concepts of GAs, in the literature there are few studies that analyze objectively the influence of using blind crossover operators for combinatorial optimization problems. For this reason, in this paper a deep study on the influence of using them is conducted. The study is based on a comparison of nine techniques applied to four well-known combinatorial optimization problems. Six of the techniques are GAs with different configurations, and the remaining three are evolutionary algorithms that focus exclusively on the mutation process. Finally, to perform a reliable comparison of these results, a statistical study of them is made, performing the normal distribution z-test.

  12. Study of spin crossover nanoparticles thermal hysteresis using FORC diagrams on an Ising-like model

    Science.gov (United States)

    Atitoaie, Alexandru; Tanasa, Radu; Stancu, Alexandru; Enachescu, Cristian

    2014-11-01

    Recent developments in the synthesis and characterization of spin crossover (SCO) nanoparticles and their prospects of switching at molecular level turned these bistable compounds into possible candidates for replacing the materials used in recording media industry for development of solid state pressure and temperature sensors or for bringing contributions in engineering. Compared to bulk samples with the same chemical structure, SCO nanoparticles display different characteristics of the hysteretic and relaxation properties like the shift of the transition temperature towards lower values along with decrease of the hysteresis width with nanoparticles size. Using an Ising-like model with specific boundary conditions within a Monte Carlo procedure, we here reproduce most of the hysteretic properties of SCO nanoparticles by considering the interaction between spin crossover edge molecules and embedding surfactant molecules and we propose a complex analysis concerning the effect of the interactions and sizes during the thermal transition in systems of SCO nanoparticles by using the First Order Reversal Curves diagram method and by comparison with similar effects in mixed crystal systems.

  13. A case-crossover study of acute alcohol use and suicide attempt.

    Science.gov (United States)

    Borges, Guilherme; Cherpitel, Cheryl J; MacDonald, Scott; Giesbrecht, Norman; Stockwell, Tim; Wilcox, Holly C

    2004-11-01

    Several studies have shown that acute alcohol use is associated with suicidal behavior, but the magnitude and nature of the relationship remain unclear. We report a study on the impact of acute alcohol use on suicide attempts treated in the emergency room (ER) using the case-crossover design. Seven ER studies carried out in the United States, Canada, Mexico and Australia from 1984 to 1996 with probability samples and similar methodology were merged yielding a total of 102 suicide attempters (overall 52% were male and 59% under 30 years of age). Thirty-six patients reported alcohol use within 6 hours prior to the suicide attempt. When usual alcohol consumption during the past 12 months served as the control value, the estimated relative risk (RR) for patients who reported alcohol use within 6 hours prior to the suicide attempt was 9.6 (95% confidence interval: 5.7-16.3). Although the prevalence of alcohol use differed by sex, there was no statistically significant difference in the estimated RRs (RR = 13.6 men and RR = 5.3 women, p = 0.11 for the heterogeneity test). A positive association was found between alcohol use 6 hours prior and suicide attempts in 102 ER cases in four countries. The case-crossover methodology is well suited to studies for which an external control group is not easily obtainable.

  14. 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.

  15. Respiratory and cardiovascular responses to walking down a traffic-polluted road compared with walking in a traffic-free area in participants aged 60 years and older with chronic lung or heart disease and age-matched healthy controls: a randomised, crossover study.

    Science.gov (United States)

    Sinharay, Rudy; Gong, Jicheng; Barratt, Benjamin; Ohman-Strickland, Pamela; Ernst, Sabine; Kelly, Frank J; Zhang, Junfeng Jim; Collins, Peter; Cullinan, Paul; Chung, Kian Fan

    2018-01-27

    Long-term exposure to pollution can lead to an increase in the rate of decline of lung function, especially in older individuals and in those with chronic obstructive pulmonary disease (COPD), whereas shorter-term exposure at higher pollution levels has been implicated in causing excess deaths from ischaemic heart disease and exacerbations of COPD. We aimed to assess the effects on respiratory and cardiovascular responses of walking down a busy street with high levels of pollution compared with walking in a traffic-free area with lower pollution levels in older adults. In this randomised, crossover study, we recruited men and women aged 60 years and older with angiographically proven stable ischaemic heart disease or stage 2 Global initiative for Obstructive Lung Disease (GOLD) COPD who had been clinically stable for 6 months, and age-matched healthy volunteers. Individuals with ischaemic heart disease or COPD were recruited from existing databases or outpatient respiratory and cardiology clinics at the Royal Brompton & Harefield NHS Foundation Trust and age-matched healthy volunteers using advertising and existing databases. All participants had abstained from smoking for at least 12 months and medications were taken as recommended by participants' doctors during the study. Participants were randomly assigned by drawing numbered disks at random from a bag to do a 2 h walk either along a commercial street in London (Oxford Street) or in an urban park (Hyde Park). Baseline measurements of participants were taken before the walk in the hospital laboratory. During each walk session, black carbon, particulate matter (PM) concentrations, ultrafine particles, and nitrogen dioxide (NO 2 ) concentrations were measured. Between October, 2012, and June, 2014, we screened 135 participants, of whom 40 healthy volunteers, 40 individuals with COPD, and 39 with ischaemic heart disease were recruited. Concentrations of black carbon, NO 2 , PM 10 , PM 2.5 , and ultrafine particles

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

    Science.gov (United States)

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

    2017-11-17

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

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Science.gov (United States)

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

    2007-05-01

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

  19. 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...... trial, 40 mg tonabersat once daily was compared with matched placebo in patients who had at least one aura attack per month during the past 3 months. Randomisation was by computer-generated list. Patients kept a detailed diary to enable objective diagnosis of each attack as migraine with aura, migraine...... without aura, or other type of headache. Primary endpoints were a reduction in aura attacks with or without headache and a reduction in migraine headache days with or without an aura. Analysis was per protocol. This trial is registered, number NCT00332007. FINDINGS: 39 patients were included in the study...

  20. [Association of air-pollution with acute myocardial infarction: A case-crossover study].

    Science.gov (United States)

    Collart, P; Coppieters, Y; Mercier, G; Dramaix, M; Levêque, A

    2015-04-01

    A large number of studies have demonstrated an association between ambient air pollutant exposures and acute myocardial infarctions (AMI). Case-crossover methods are frequently used for analyzing the acute health effects of air pollution. Nevertheless, only a few studies controlled for potential confounders like other air pollutants and temperature. The defined geographic entity for the collection of acute myocardial infarctions was composed of 15 municipalities in Charleroi. Charleroi is a relatively highly polluted region in Wallonia, the South of Belgium. The analyses presented hereafter concern patients in the 25-74 years age range over time from 1999 to 2009. Ambient concentrations of PM10, O3, NO2, CO and temperature were available from stationary monitors during this time period. A time-stratified case-crossover approach was applied. Season stratified analysis and analysis matching for environmental confounders were also performed. A total of 3303 AMIs were analyzed during the study period. For the entire year, O3 was significantly associated with AMI, OR=1.028 (CI95%: 1.003-1.054). The highest associations (for a 10 μg.m(-3) rise in pollutant levels) between air pollution and myocardial infarction were observed for PM10 and O3 during the warm period, OR=1.086 (CI95%: 1.020-1.151) and 1.064 (CI95%: 1.024-1.105), respectively. Matching cases and controls for temperature produced weaker association between O3 and AMI (OR=1.003, CI95%: 0.974-1.032). In contrast, this matching had no effect on the association between PM10 and AMI. The adjustment for NO2 concentration decreased the association between PM10 and AMI. The results of this study reinforce the evidence of the short-term effects of air pollution on acute myocardial infarction, especially during the warm season. This also suggests that the case-crossover method is a suitable tool in studying the association between acute events and air pollution. Controlling for potential environmental confounding

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

    NARCIS (Netherlands)

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

    2012-01-01

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

  2. 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.

  3. Study of the fast photoswitching of spin crossover nanoparticles outside and inside their thermal hysteresis loop

    Science.gov (United States)

    Gallé, G.; Etrillard, C.; Degert, J.; Guillaume, F.; Létard, J.-F.; Freysz, E.

    2013-02-01

    We have studied the low spin to high spin phase transition induced by nanosecond laser pulses outside and within the thermal hysteresis loop of the [Fe(Htrz)2 trz](BF4)2-H2O spin crossover nanoparticles. We demonstrate that, whatever the temperature of the compound, the photo-switching is achieved in less than 12.5 ns. Outside the hysteresis loop, the photo-induced high spin state remains up to 100 μs and then relaxes. Within the thermal hysteresis loop, the photo-induced high spin state remains as long as the temperature of the sample is kept within the thermal loop. A Raman study indicates that the photo-switching can be completed using single laser pulse excitation.

  4. Levetiracetam in primary orthostatic tremor: a double-blind placebo-controlled crossover study.

    Science.gov (United States)

    Hellriegel, Helge; Raethjen, Jan; Deuschl, G; Volkmann, Jens

    2011-11-01

    In a double-blind crossover study we evaluated the antitremor effect of a 4-week treatment with either escalating dosages of levetiracetam or placebo in orthostatic tremor. Twelve patients with orthostatic tremor participated in the study. Primary end point was improvement in stance duration. Secondary end points were total track length of the sway path and tremor total power. The patients' impression of impairment was assessed by a visual analog scale and quality of life by the SF-36. We found no significant effect of dosage or treatment on stance duration (P = .175), total track length (P = .690), total power (P = .280), or visual analog scale (P =.735). Neither was SF-36 differentially changed by levetiracetam or placebo (SF-36, Physical Component Summary: P = .079; SF-36, Mental Component Summary: P = .073). Side effects like dizziness, fatigue, or nausea were only mild to moderate. Levetiracetam is ineffective in the treatment of orthostatic tremor. Copyright © 2011 Movement Disorder Society.

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

    Science.gov (United States)

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

    2016-01-01

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

  6. Semiparametric time varying coefficient model for matched case-crossover studies.

    Science.gov (United States)

    Ortega-Villa, Ana Maria; Kim, Inyoung; Kim, H

    2017-03-15

    In matched case-crossover studies, it is generally accepted that the covariates on which a case and associated controls are matched cannot exert a confounding effect on independent predictors included in the conditional logistic regression model. This is because any stratum effect is removed by the conditioning on the fixed number of sets of the case and controls in the stratum. Hence, the conditional logistic regression model is not able to detect any effects associated with the matching covariates by stratum. However, some matching covariates such as time often play an important role as an effect modification leading to incorrect statistical estimation and prediction. Therefore, we propose three approaches to evaluate effect modification by time. The first is a parametric approach, the second is a semiparametric penalized approach, and the third is a semiparametric Bayesian approach. Our parametric approach is a two-stage method, which uses conditional logistic regression in the first stage and then estimates polynomial regression in the second stage. Our semiparametric penalized and Bayesian approaches are one-stage approaches developed by using regression splines. Our semiparametric one stage approach allows us to not only detect the parametric relationship between the predictor and binary outcomes, but also evaluate nonparametric relationships between the predictor and time. We demonstrate the advantage of our semiparametric one-stage approaches using both a simulation study and an epidemiological example of a 1-4 bi-directional case-crossover study of childhood aseptic meningitis with drinking water turbidity. We also provide statistical inference for the semiparametric Bayesian approach using Bayes Factors. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

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

    Science.gov (United States)

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

    2015-04-01

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

  8. A comparative evaluation of drops versus atomized administration of intranasal ketamine for the procedural sedation of young uncooperative pediatric dental patients: a prospective crossover trial.

    Science.gov (United States)

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

    2011-01-01

    The objective of this study was to compare and evaluate the efficacy and safety of drops and atomized administration of intranasal ketamine (INK) in terms of behavioral response for agent acceptance during administration and for agent efficacy and safety for the sedation of young uncooperative pediatric dental patients. Thirty-four uncooperative ASA grade-1 children, requiring dental treatment were randomly assigned to receive INK as drops and atomized spray in one of the subsequent visit. This was a two stage cross-over trial and each child received INK by both modes of administration. The vital signs were monitored continuously during each visit. A statistically significant difference in patients acceptance (P intranasal (IN) drug administration for moderate sedation in facilitating dental care for anxious and uncooperative pediatric dental patients. Moreover, INK when administered with the mucosal atomization device, the acceptance of the drug was associated with less aversive reaction, rapid onset and recovery of sedation, as compared to the drop administration of the same agent.

  9. Comparative Packaging Study

    Science.gov (United States)

    Perchonok, Michele; Antonini, David

    2008-01-01

    This viewgraph presentation describes a comparative packaging study for use on long duration space missions. The topics include: 1) Purpose; 2) Deliverables; 3) Food Sample Selection; 4) Experimental Design Matrix; 5) Permeation Rate Comparison; and 6) Packaging Material Information.

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

    Science.gov (United States)

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

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

  11. Rushing, distraction, walking on contaminated floors and risk of slipping in limited-service restaurants: a case--crossover study.

    Science.gov (United States)

    Verma, Santosh K; Lombardi, David A; Chang, Wen Ruey; Courtney, Theodore K; Huang, Yueng-Hsiang; Brennan, Melanye J; Mittleman, Murray A; Ware, James H; Perry, Melissa J

    2011-08-01

    This nested case-crossover study examined the association between rushing, distraction and walking on a contaminated floor and the rate of slipping, and whether the effects varied according to weekly hours worked, job tenure and use of slip-resistant shoes. At baseline, workers from 30 limited-service restaurants in the USA reported average work hours, average weekly duration of exposure to each transient risk factor and job tenure at the current location. Use of slip-resistant shoes was determined. During the following 12 weeks, participants reported weekly their slip experience and exposures to the three transient exposures at the time of slipping. The case-crossover design was used to estimate the rate ratios using the Mantel-Haenszel estimator for person-time data. Among 396 participants providing baseline information, 210 reported one or more slips with a total of 989 slips. Rate of slipping was 2.9 times higher when rushing as compared to working at a normal pace (95% CI 2.5 to 3.3). Rate of slipping was also significantly increased by distraction (rate ratio (RR) 1.7, 95% CI 1.5 to 2.0) and walking on a contaminated floor (RR 14.6, 95% CI 12.6 to 17.0). Use of slip-resistant shoes decreased the effects of rushing and walking on a contaminated floor. Rate ratios for all three transient factors decreased monotonically as job tenure increased. The results suggest the importance of these transient risk factors, particularly floor contamination, on rate of slipping in limited-service restaurant workers. Stable characteristics, such as slip-resistant shoes, reduced the effects of transient exposures.

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

    Science.gov (United States)

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

    2017-04-01

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

  13. Mossbauer spectroscopic study of the thermal spin crossover in [Fe(II)(isoxazole)(6)](ClO(4))(2)

    NARCIS (Netherlands)

    Bhattacharjee, A.; van Koningsbruggen, P. J.; Miller, Joel S.; Guetlich, P.

    2008-01-01

    The (57)Fe Mossbauer spectroscopy of mononuclear [Fe(II)(isoxazole)(6)](ClO(4))(2) has been studied to reveal the thermal spin crossover of Fe(II) between low-spin (S = 0) and high-spin (S = 2) states.Temperature-dependent spin transition curves have been constructed with the least-square fitted

  14. Effects of magnetic stray fields from a 7 Tesla MRI scanner on neurocognition: a double-blind randomised crossover study

    NARCIS (Netherlands)

    van Nierop, L.E.; Slottje, P.; van Zandvoort, M.J.; de Vocht, F.; Kromhout, H.

    2012-01-01

    OBJECTIVE This study characterises neurocognitive domains that are affected by movement-induced time-varying magnetic fields (TVMF) within a static magnetic stray field (SMF) of a 7 Tesla (T) MRI scanner. METHODS Using a double-blind randomised crossover design, 31 healthy volunteers were tested in

  15. Study of thermal spin crossover in [Fe(II)(isoxazole)(6)](BF4)(2) with Mossbauer spectroscopy

    NARCIS (Netherlands)

    Bhattacharjee, A.; van Koningsbruggen, P. J.; Hibbs, W.; Miller, Joel S.; Guetlich, P.

    2007-01-01

    Fe-57 Mossbauer spectroscopy of the mononuclear [Fe( II)( isoxazole)(6)]( BF4)(2) compound has been studied to reveal the thermal spin crossover of Fe( II) between low- spin ( S = 0) and high- spin ( S = 2) states. A temperature-dependent spin transition curve has been constructed with the least-

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

    Directory of Open Access Journals (Sweden)

    Anisse Penning

    2017-08-01

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

  17. The Preservation of Cued Recall in the Acute Mentally Fatigued State: A Randomised Crossover Study.

    Science.gov (United States)

    Flindall, Ian Richard; Leff, Daniel Richard; Pucks, Neysan; Sugden, Colin; Darzi, Ara

    2016-01-01

    The objective of this study is to investigate the impact of acute mental fatigue on the recall of clinical information in the non-sleep-deprived state. Acute mental fatigue in the non-sleep-deprived subject is rarely studied in the medical workforce. Patient handover has been highlighted as an area of high risk especially in fatigued subjects. This study evaluates the deterioration in recall of clinical information over 2 h with cognitively demanding work in non-sleep-deprived subjects. A randomised crossover study involving twenty medical students assessed free (presentation) and cued (MCQ) recall of clinical case histories at 0 and 2 h under low and high cognitive load using the N-Back task. Acute mental fatigue was assessed through the Visual Analogue Scale, Stanford Scale and NASA-TLX Mental Workload Rating Scale. Free recall is significantly impaired by increased cognitive load (p recall under high and low cognitive load conditions (p = 1). This study demonstrates the loss of clinical information over a short time period involving a mentally fatiguing, high cognitive load task. Free recall for the handover of clinical information is unreliable. Memory cues maintain recall of clinical information. This study provides evidence towards the requirement for standardisation of a structured patient handover. The use of memory cues (involving recognition memory and cued recall methodology) would be beneficial in a handover checklist to aid recall of clinical information and supports evidence for their adoption into clinical practice.

  18. Double-blind, placebo-controlled, crossover study of lamotrigine in treatment-resistant generalised epilepsy.

    Science.gov (United States)

    Beran, R G; Berkovic, S F; Dunagan, F M; Vajda, F J; Danta, G; Black, A B; Mackenzie, R

    1998-12-01

    Lamotrigine (LTG) is recognised as effective add-on therapy for focal epilepsies, but this is the first double-blind, placebo-controlled, crossover study in treatment-resistant generalised epilepsy. The study consisted of 2 x 8-week treatment periods followed by a 4-week washout period. Patients received doses of either 75 or 150 mg daily, depending on their concomitant antiepileptic drugs (AEDs). Long-term continuation was offered at the end of the study with open-label LTG. Five centres in Australia recruited 26 patients who were having absence, myoclonic, or generalized tonic-clonic seizures or a combination of these. Twenty-two patients completed the study. There was a significant reduction in frequency of both tonic-clonic and absence seizure types with LTG. A 350% decrease in seizures was observed for tonic-clonic seizures in 50% of cases and for absence seizures in 33% of evaluable cases. Rash was the only adverse effect causing discontinuation. Twenty-three of 26 opted for open-label LTG, with 20 still receiving LTG for a mean of 26 months. In these 20, 80% had > or =50% seizure reduction and five (25%) were seizure free. This study shows that LTG is effective add-on therapy in patients with refractory generalised epilepsies. Statistically significant reduction in seizures in both absence and tonic-clonic seizure types was seen even with low doses of LTG.

  19. 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.

  20. Smoking Behavior and Exposure: Results of a Menthol Cigarette Cross-over Study.

    Science.gov (United States)

    Watson, Christina Vaughan; Richter, Patricia; de Castro, B Rey; Sosnoff, Connie; Potts, Jennifer; Clark, Pamela; McCraw, Joan; Yan, Xizheng; Chambers, David; Watson, Clifford

    2017-05-01

    Our objective was to improve understanding of the differences in use behavior and exposure when smoking menthol and non-menthol cigarettes using a 2-part cross-over design. Adult daily smokers were assigned randomly to alternate between 2 weeks of exclusively smoking a menthol test cigarette or a non-menthol test cigarette. Urine and saliva were collected for biomarker measurements; carbon monoxide (CO) was measured, and participants smoked test cigarettes through a CreSS® smoking topography device during 3 clinic visits. Participants turned in their cigarette butts from the test periods for determination of mouth level nicotine and completed subjective questionnaires related to the test cigarettes. Regardless of cigarette preference, participants had higher salivary cotinine when smoking the non-menthol test cigarette, but there were no significant differences detected in urine 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol between the 2 test cigarettes. Mouth level nicotine, puff volume, and puff duration were significantly higher when smoking the menthol brand. Both menthol and non-menthol smokers reported significantly lower enjoyment and satisfaction scores for test cigarettes compared with their brand of choice. Our results suggest that mentholation has an effect on measures of smoking behavior and that mouth level nicotine is a useful indicator of between-brand smoke exposure.

  1. Digital dictation and voice transcription software enhances outpatient clinic letter production: a crossover study.

    Science.gov (United States)

    Patel, Kinesh; Harbord, Marcus

    2012-07-01

    Digital voice transcription has been introduced widely in the National Health Service (NHS), though primarily in radiology departments. There has been a long-standing problem with recruitment of medical secretaries within the NHS, leading to long delays in the production of correspondence from outpatient clinics. To determine whether use of widely available digital transcription software improves efficiency and the time taken to produce correspondence. The project used a prospective, crossover trial design in a 'real-world' environment. Correspondence from clinics was transcribed after dictation by a secretary using conventional analogue audio tape or the dictation software. After a 2-week washout period the same clinics' dictations were transcribed using the other method to produce identical correspondence. The two sets of letters were compared. The mean time for the secretary to produce letters for a complete clinic using digital dictation was 66 min whereas analogue dictation took 121 min (p0.05). Voice transcription software significantly decreased the time taken to transcribe outpatient clinic letters with minimal training of secretarial staff, resulting in improved efficiency.

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

    Directory of Open Access Journals (Sweden)

    Robson Luis Oliveira de Amorim

    2017-05-01

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

  3. Study of comparative bioavailability of omeprazole pellets.

    Science.gov (United States)

    Karim, Sabiha; Hay, Yuen Kah; Baie, Saringat H; Bukhari, Nadeem Irfan; Murtaza, Ghulam

    2014-01-01

    The objective of this study was to assess the bioequivalence between the omeprazole laboratory based formulation and the commercial formulation, Zimor Rubio, Spain, considered as reference formulation. The experiment was carried out according to a 2-period, 2-sequence crossover design with a two week washout period. A validated high performance liquid chromatographic method was applied for in vivo experiments. It was observed that omeprazole contents were comparable in all formulations. To establish bioequivalence, 90% confidence intervals (CI) for the differences of total AUCs of the test and reference formulations were calculated. The 95% CI ratio of the AUC within 0.80 to 1.25 was considered as bioequivalent. The carryout effect was investigated prior to assessing the bioequivalence of the two formulations. The test formulation of omeprazole was found to be comparable with the reference formulation (Zimor) with regard to bioavailability.

  4. A Case Crossover Study: Air Pollution and Myocard Infarction Related Hospitalizations Relationship. Kocaeli Experience

    Directory of Open Access Journals (Sweden)

    Onur Gunay

    2009-10-01

    Full Text Available AIM: Kocaeli is one of the most industrialized cities of Turkey. Many industrial facilities in terms of air pollution, constitute a risk. Because of Kocaeli’s location, which is on the junction of Turkey’s whole motorway transport, increases the importance of this issue. The purpose of this study is to determine whether or not a relationship between air pollution measurement parameters (SO2 and PM and Myocard Infarction (MI related hospitalizations. METHOD: In this study, the relationship between MI related hospitalizations which occured in Kocaeli in 2004 and measurements of SO2 and PM were investigated. Study was analytical type and case-crossover (CCO design was used. RESULTS: Three hospitals’ (which have coronary intensive care units and which are located in Kocaeli patient records have been searched and a total of 428 MI related hospitalizations have been identified in data collecting phase, and it’s determined that these 428 hospitalizations were involving 417 individuals. Of the 428 hospitalization records, 318 were eligible for CCO analysis criteriae and included to analyze. CONCLUSION: In conclusion by investigating the relationship between MI related hospitalizations and measured SO2 and PM levels in Kocaeli, we found that a 10 μg/m3 increase in SO2 levels, significantly increase the risk of MI in cold season (October-March. [TAF Prev Med Bull 2009; 8(5.000: 381-388

  5. Relationship between asian dust and ischemic stroke: a time-stratified case-crossover study.

    Science.gov (United States)

    Kamouchi, Masahiro; Ueda, Kayo; Ago, Tetsuro; Nitta, Hiroshi; Kitazono, Takanari

    2012-11-01

    Particulate matter is increasingly recognized as a cause of human diseases, including cardiovascular diseases. However, the association between Asian dust (AD), a windblown sand dust originating from mineral soil in the deserts of China and Mongolia, and the incidence of cardiovascular diseases is unclear. The aim of the present study was to elucidate whether AD is associated with the incidence of ischemic stroke. This study investigated the onset time of 7429 consecutive patients with ischemic stroke who were admitted to seven stroke centers in Fukuoka, Japan, between June 1999 and March 2010. Meteorologic variables and air pollutants, including AD and suspended particulate matters, were investigated during the identical period. A time-stratified case-crossover study was conducted to assess the association between AD and stroke incidence using a conditional logistic regression analysis. Although AD was not significantly associated with the overall incidence of ischemic stroke, there was a relationship specific to the stroke subtypes. AD was significantly associated with the incidence of atherothrombotic brain infarction after adjusting for expected confounders, including meteorologic variables and other air pollutants. No association was detected in other types of ischemic stroke. These data suggest that AD does not increase the overall incidence of ischemic stroke, but it is specifically associated with the risk of atherothrombotic brain infarction.

  6. A crossover trial comparing wide dynamic range compression and frequency compression in hearing aids for tinnitus therapy.

    Science.gov (United States)

    Hodgson, Shirley-Anne; Herdering, Regina; Singh Shekhawat, Giriraj; Searchfield, Grant D

    2017-01-01

    It has been suggested that frequency lowering may be a superior tinnitus reducing digital signal processing (DSP) strategy in hearing aids than conventional amplification. A crossover trial was undertaken to determine if frequency compression (FC) was superior to wide dynamic range compression (WDRC) in reducing tinnitus. A 6-8-week crossover trial of two digital signal-processing techniques (WDRC and 2 WDRC with FC) was undertaken in 16 persons with high-frequency sensorineural hearing loss and chronic tinnitus. WDRC resulted in larger improvements in Tinnitus Functional Index and rating scale scores than WDRC with FC. The tinnitus improvements obtained with both processing types appear to be due to reduced hearing handicap and possibly decreased tinnitus audibility. Hearing aids are useful assistive devices in the rehabilitation of tinnitus. FC was very successful in a few individuals but was not superior to WDRC across the sample. It is recommended that WDRC remain as the default first choice tinnitus hearing aid processing strategy for tinnitus. FC should be considered as one of the many other options for selection based on individual hearing needs. Implications of Rehabilitation Hearing aids can significantly reduce the effects of tinnitus after 6-8 weeks of use. Addition of frequency compression digital signal processing does not appear superior to standard amplitude compression alone. Improvements in tinnitus were correlated with reductions in hearing handicap.

  7. Study on nature of crossover phenomena with application to gearbox fault diagnosis

    Science.gov (United States)

    Jiang, Xingxing; Li, Shunming; Wang, Yong

    2017-01-01

    Detrended Fluctuation Analysis (DFA) is a robust tool for uncovering long-range correlations hidden in the non-stationary data. Recently, crossover properties of the scaling-law curve obtained by DFA have been applied to diagnose gearbox faults. However, the nature of the crossover phenomena has not been well- explained. In this paper, an explanation for the nature of crossover phenomena is specifically given, which is conducive to discovering novel features for gearbox fault diagnosis. Firstly, an explicit exposition of the crossover phenomena is provided by analyzing the gearbox vibration signal. Secondly, the nature of crossover phenomena is specifically disclosed. Thirdly, the features with clear physical meaning are proposed to describe operating conditions of a gearbox. Then, to overcome the deficiency of feature extraction through visual observation, a piecewise-linear regression model is utilized to extract the features automatically. Lastly, several combinations of these features are used to classify the fault types. As a consequence, the proposed novel features are verified that they can well- distinguish the gearbox operating conditions with different fault types and severities, and deliver a better performance than the existing method depending on the sensitive index (SI).

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Marcela Janka-Zires

    2016-01-01

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

  10. Impact of Michelangelo prosthetic hand: Findings from a crossover longitudinal study.

    Science.gov (United States)

    Luchetti, Martina; Cutti, Andrea G; Verni, Gennaro; Sacchetti, Rinaldo; Rossi, Nicolino

    2015-01-01

    This work explores the functional and psychosocial impact of the multigrip Michelangelo (M) prosthetic hand. Transradial myoelectric prosthesis users (6 men, median age: 47 y) participated in a crossover longitudinal study. A multifactorial assessment protocol was applied before the application of M and after 3 mo (functional assessment) and 6 mo (psychosocial assessment) of home use. Functional assessment included both practical tests (i.e., Southampton Hand Assessment Procedure [SHAP], Box and Blocks Test [BBT], and Minnesota Manual Dexterity Test [MMDT]) and self-report functional scales. Psychosocial assessment consisted of a clinical interview and a battery of self-report questionnaires concerning current anxious-depressive symptoms and health-related quality of life, body image concerns, adjustment and satisfaction with prosthesis, social support, coping style, and personality. Increased manual dexterity was observed after 3 mo based on improvements in the SHAP, BBT, and MMDT. Two important themes emerged from the clinical interviews at the 6 mo follow-up: (1) the enhanced functionality and (2) the "like a real hand" aspect of the M, which further increased prosthesis integration to the Self. A few patients expressed concerns about M dimension, noise, and weight. The M appeared to restore hand function and natural appearance. The present findings provide preliminary evidence, and additional studies are needed.

  11. Methylene blue treatment for residual symptoms of bipolar disorder: randomised crossover study.

    Science.gov (United States)

    Alda, Martin; McKinnon, Margaret; Blagdon, Ryan; Garnham, Julie; MacLellan, Susan; O'Donovan, Claire; Hajek, Tomas; Nair, Cynthia; Dursun, Serdar; MacQueen, Glenda

    2017-01-01

    Residual symptoms and cognitive impairment are among important sources of disability in patients with bipolar disorder. Methylene blue could improve such symptoms because of its potential neuroprotective effects. We conducted a double-blind crossover study of a low dose (15 mg, 'placebo') and an active dose (195 mg) of methylene blue in patients with bipolar disorder treated with lamotrigine. Thirty-seven participants were enrolled in a 6-month trial (trial registration: NCT00214877). The outcome measures included severity of depression, mania and anxiety, and cognitive functioning. The active dose of methylene blue significantly improved symptoms of depression both on the Montgomery-Åsberg Depression Rating Scale and Hamilton Rating Scale for Depression (P = 0.02 and 0.05 in last-observation-carried-forward analysis). It also reduced the symptoms of anxiety measured by the Hamilton Rating Scale for Anxiety (P = 0.02). The symptoms of mania remained low and stable throughout the study. The effects of methylene blue on cognitive symptoms were not significant. The medication was well tolerated with transient and mild side-effects. Methylene blue used as an adjunctive medication improved residual symptoms of depression and anxiety in patients with bipolar disorder. © The Royal College of Psychiatrists 2017.

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

    Science.gov (United States)

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

    2008-11-01

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

  13. Computed Tomographic Angiography-Based Planning of Bipedicled DIEP Flaps with Intraflap Crossover Anastomosis: An Anatomical and Clinical Study.

    Science.gov (United States)

    Kim, So Young; Lee, Kyeong-Tae; Mun, Goo-Hyun

    2016-09-01

    When using deep inferior epigastric artery perforator (DIEP) flaps in breast reconstruction, harvesting bipedicled flaps can be a valuable option in cases requiring the transfer of a large portion of harvested flaps. Connecting the bilateral deep inferior epigastric arteries (DIEAs) by intraflap crossover anastomosis is one of the most popular methods of constructing bipedicled DIEP flaps. Planning the primary and secondary pedicle configurations for reliable intraflap crossover anastomosis is crucial. To achieve this, detailed anatomical DIEA information might be helpful. However, meticulous planning of bipedicled DIEP flaps based on computed tomographic angiography has not been reported. Detailed anatomical investigation of DIEA branches was conducted using computed tomographic angiographs of 100 hemiabdomens. Thirty-eight prospectively collected patients who underwent breast reconstruction using bipedicled DIEP flaps with intraflap crossover under computed tomographic angiography-based planning were reviewed. Three intramuscular DIEA branching patterns with distinct branch point topography, branch diameters, and superior continuations cranial to sizable perforators were observed. In the prospective clinical study, a primary pedicle with a recipient branch for intraflap crossover anastomosis could be specified preoperatively using computed tomographic angiography-based anatomical data of the pedicles, including size of DIEA branches or their superior continuation and size of perforators. In all cases, the bipedicle configuration was easily achieved as planned on computed tomographic angiography, and secure perfusion of the entire flap was achieved. The authors' results suggest that computed tomographic angiography provides detailed anatomical DIEA information, and comprehensive analysis of these data allows precise planning of bipedicle configurations with intraflap crossover anastomosis in DIEP flaps. Therapeutic, IV.

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

    Science.gov (United States)

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

    2018-03-01

    Andersen, V, Fimland, MS, Mo, D-A, Iversen, VM, Vederhus, T, Rockland Hellebø, LR, Nordaune, KI, and Saeterbakken, AH. Electromyographic comparison of barbell deadlift, hex bar deadlift, and hip thrust exercises: a cross-over study. J Strength Cond Res 32(3): 587-593, 2018-The aim of the study was to compare the muscle activation level of the gluteus maximus, biceps femoris, and erector spinae in the hip thrust, barbell deadlift, and hex bar deadlift; each of which are compound resisted hip extension exercises. After 2 familiarization sessions, 13 resistance-trained men performed a 1 repetition maximum in all 3 exercises in 1 session, in randomized and counterbalanced order. The whole ascending movement (concentric phase), as well as its lower and upper parts (whole movement divided in 2), were analyzed. The hip thrust induced greater activation of the gluteus maximus compared with the hex bar deadlift in the whole (16%, p = 0.025) and the upper part (26%, p = 0.015) of the movement. For the whole movement, the biceps femoris was more activated during barbell deadlift compared with both the hex bar deadlift (28%, p hip thrust (20%, p = 0.005). In the lower part of the movement, the biceps femoris activation was, respectively, 48% and 26% higher for the barbell deadlift (p hip thrust. Biceps femoris activation in the upper part of the movement was 39% higher for the barbell deadlift compared with the hex bar deadlift (p = 0.001) and 34% higher for the hip thrust compared with the hex bar deadlift (p = 0.002). No differences were displayed for the erector spinae activation (p = 0.312-0.859). In conclusion, the barbell deadlift was clearly superior in activating the biceps femoris compared with the hex bar deadlift and hip thrust, whereas the hip thrust provided the highest gluteus maximus activation.

  15. Pharmacokinetics of a new once-daily controlled-release formulation of aceclofenac in Korean healthy subjects compared with immediate-release aceclofenac and the effect of food: a randomized, open-label, three-period, crossover, single-centre study.

    Science.gov (United States)

    Bae, Soo Kyung; Kim, Soo-Hwan; Lee, Hae Won; Seong, Sook Jin; Shin, Su-Yeon; Lee, Sang Hun; Lim, Mi-Sun; Yoon, Young-Ran; Lee, Hye Jung

    2012-02-01

    A new controlled-release formulation of aceclofenac 200 mg (Clanza CR®) developed by Korea United Pharm., Inc., South Korea, for once-daily (od) dosing provides biphasic aceclofenac release consisting of immediate release of 85 mg followed by sustained release of 115 mg. Food has been known to affect the rate and extent of absorption of several drugs, in both immediate-release and controlled-release formulations. The aim of this study was to evaluate the relative bioavailability of a new controlled-release formulation of aceclofenac (200 mg od; Clanza CR®) in comparison with immediate-release aceclofenac (100 mg twice daily [bid], Airtal®) and to assess the effect of food on the pharmacokinetics of the new controlled-release aceclofenac formulation. This study was designed as a randomized, open-label, three treatment-period, crossover, single-centre study with a 1-week washout in 41 healthy adults. The three treatments consisted of immediate-release aceclofenac 100 mg bid administered under fasting conditions; controlled-release aceclofenac 200 mg od administered under fasting conditions; and controlled-release aceclofenac 200 mg od administered immediately after a standardized high-fat breakfast. Plasma concentrations of aceclofenac were determined using a high-performance liquid chromatography method. In the fasted state, the 90% confidence intervals (CIs) of the least squares geometric mean ratios (GMRs) for the area under the plasma concentration-time curve from time zero to 24 hours (AUC(24)) and the peak plasma concentration (C(max)) of aceclofenac for the controlled-release and immediate-release formulations of aceclofenac were all within the bioequivalence criteria range of 0.8-1.25. The 90% CIs of the GMRs for the AUC(24) and C(max) of aceclofenac for the controlled-release formulation of aceclofenac in the fed and fasted states were also within the bioequivalence range. Both aceclofenac formulations were well tolerated in all subjects

  16. Optimising abdominal space with deep neuromuscular blockade in gynaecologic laparoscopy--a randomised, blinded crossover study.

    Science.gov (United States)

    Madsen, M V; Gätke, M R; Springborg, H H; Rosenberg, J; Lund, J; Istre, O

    2015-04-01

    Insufflation of the abdomen during laparoscopy improves surgical space, but may cause post-operative shoulder pain. The incidence of shoulder pain is reduced using a lower insufflation pressure, but this may, however, compromise the surgical space. We aimed at investigating whether deep neuromuscular blockade (NMB) would enlarge surgical space, measured as the distance from the sacral promontory to the trocar in patients undergoing gynaecologic laparoscopy. Fourteen patients were randomised in an assessor-blinded crossover design. The distance from the sacral promontory to the trocar was measured during deep NMB and without NMB at pneumoperitoneum 8 and 12 mmHg both. Additionally, we assessed surgical conditions while suturing the abdominal fascia using a 4-point subjective rating scale. Deep NMB was established with rocuronium and reversed with sugammadex. At 12 mmHg pneumoperitoneum, deep NMB improved surgical space with a mean of 0.33 cm (95% confidence interval 0.07-0.59) (P=0.01, paired t-test) compared with no NMB. At 8 mmHg pneumoperitoneum deep NMB improved surgical space with a mean of 0.3 cm (95% confidence interval, 0.06-0.54) (P=0.005) compared with no NMB. Deep NMB resulted in significantly better ratings of surgical conditions during suturing of the fascia (P=0.03, Mann-Whitney U-test). Deep NMB enlarged surgical space measured as the distance from the sacral promontory to the trocar. The enlargement, however, was minor and the clinical significance is unknown. Moreover, deep NMB improved surgical conditions when suturing the abdominal fascia. © 2015 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  17. Route infrastructure and the risk of injuries to bicyclists: a case-crossover study.

    Science.gov (United States)

    Teschke, Kay; Harris, M Anne; Reynolds, Conor C O; Winters, Meghan; Babul, Shelina; Chipman, Mary; Cusimano, Michael D; Brubacher, Jeff R; Hunte, Garth; Friedman, Steven M; Monro, Melody; Shen, Hui; Vernich, Lee; Cripton, Peter A

    2012-12-01

    We compared cycling injury risks of 14 route types and other route infrastructure features. We recruited 690 city residents injured while cycling in Toronto or Vancouver, Canada. A case-crossover design compared route infrastructure at each injury site to that of a randomly selected control site from the same trip. Of 14 route types, cycle tracks had the lowest risk (adjusted odds ratio [OR] = 0.11; 95% confidence interval [CI] = 0.02, 0.54), about one ninth the risk of the reference: major streets with parked cars and no bike infrastructure. Risks on major streets were lower without parked cars (adjusted OR = 0.63; 95% CI = 0.41, 0.96) and with bike lanes (adjusted OR = 0.54; 95% CI = 0.29, 1.01). Local streets also had lower risks (adjusted OR = 0.51; 95% CI = 0.31, 0.84). Other infrastructure characteristics were associated with increased risks: streetcar or train tracks (adjusted OR = 3.0; 95% CI = 1.8, 5.1), downhill grades (adjusted OR = 2.3; 95% CI = 1.7, 3.1), and construction (adjusted OR = 1.9; 95% CI = 1.3, 2.9). The lower risks on quiet streets and with bike-specific infrastructure along busy streets support the route-design approach used in many northern European countries. Transportation infrastructure with lower bicycling injury risks merits public health support to reduce injuries and promote cycling.

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

    Science.gov (United States)

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

    2011-06-01

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

  19. A double-blind placebo-controlled crossover study of mebeverine and mefenamic acid in the treatment of primary dysmenorrhoea.

    Science.gov (United States)

    Langrick, A F; Gunn, A D; Livesey, H; Whitehead, A M

    1989-09-01

    i) To compare the efficacy of mebeverine, mefenamic acid and placebo in relieving the symptoms of primary dysmenorrhoea. ii) To compare the incidence of concurrent effects during treatment with mebeverine, mefenamic acid and placebo. Double-blind, prospectively randomised, three-way crossover study of mebeverine, mefenamic acid and placebo during three consecutive menstrual cycles. University health centres in the UK. Sixty-four females suffering from primary dysmenorrhoea who experienced pain during every menstrual cycle. Dosage was two capsules, three times daily, of mebeverine, mefenamic acid or placebo. Each mebeverine capsule contained 135 mg mebeverine hydrochloride, and each mefenamic acid capsule contained 250 mg mefenamic acid. Paracetamol (up to 2 x 500 mg) was permitted, if required, as rescue analgesia. Details of pain severity, nausea, abdominal bloating and disruption to daily activities were recorded by means of clinician assessments and patient diaries. Patients indicated their treatment preference after three cycles. Mebeverine and mefenamic acid were superior to placebo in reducing pain severity (p less than 0.01 and p less than 0.02 respectively), and mefenamic acid reduced the level of disruption to normal activities (p less than 0.01). The number of concurrent effects reported was five during treatment with mefenamic acid and one each during treatment with placebo and mebeverine. Mebeverine and mefenamic acid are effective in relieving symptoms of dysmenorrhoea.

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

    Science.gov (United States)

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

    2011-04-01

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

  1. Associations of daily pediatric asthma emergency department visits with air pollution in Newark, NJ: utilizing time-series and case-crossover study designs.

    Science.gov (United States)

    Gleason, Jessie A; Fagliano, Jerald A

    2015-10-01

    Asthma is one of the most common chronic diseases affecting children. This study assesses the associations of ozone and fine particulate matter (PM2.5) with pediatric emergency department visits in the urban environment of Newark, NJ. Two study designs were utilized and evaluated for usability. We obtained daily emergency department visits among children aged 3-17 years with a primary diagnosis of asthma during April to September for 2004-2007. Both a time-stratified case-crossover study design with bi-directional control sampling and a time-series study design were utilized. Lagged effects (1-d through 5-d lag, 3-d average, and 5-d average) of ozone and PM2.5 were explored and a dose-response analysis comparing the bottom 5th percentile of 3-d average lag ozone with each 5 percentile increase was performed. Associations of interquartile range increase in same-day ozone were similar between the time-series and case-crossover study designs (RR = 1.08, 95% CI 1.04-1.12) and (OR = 1.10, 95% CI 1.06-1.14), respectively. Similar associations were seen for 1-day lag and 3-day average lag ozone levels. PM2.5 was not associated with the outcome in either study design. Dose-response assessment indicated a statistically significant and increasing association around 50-55 ppb consistent for both study designs. Ozone was statistically positively associated with pediatric asthma ED visits in Newark, NJ. Our results were generally comparable across the time-series and case-crossover study designs, indicating both are useful to assess local air pollution impacts.

  2. Recent Studies on Methanol Crossover in Liquid-Feed Direct Methanol Fuel Cells

    Science.gov (United States)

    Valdez, T. I.; Narayanan, S. R.

    2000-01-01

    In this work, the effects of methanol crossover and airflow rates on the cathode potential of an operating direct methanol fuel cell are explored. Techniques for quantifying methanol crossover in a fuel cell and for separating the electrical performance of each electrode in a fuel cell are discussed. The effect of methanol concentration on cathode potential has been determined to be significant. The cathode is found to be mass transfer limited when operating on low flow rate air and high concentrations of methanol. Improvements in cathode structure and operation at low methanol concentration have been shown to result in improved cell performance.

  3. Omega-3 fatty acids modify human cortical visual processing--a double-blind, crossover study.

    Directory of Open Access Journals (Sweden)

    Isabelle Bauer

    Full Text Available While cardiovascular and mood benefits of dietary omega-3 fatty acids such as docosahexaenoic acid (DHA and eicosapentaenoic acid (EPA are manifest, direct neurophysiological evidence of their effects on cortical activity is still limited. Hence we chose to examine the effects of two proprietary fish oil products with different EPA:DHA ratios (EPA-rich, high EPA:DHA; DHA-rich on mental processing speed and visual evoked brain activity. We proposed that nonlinear multifocal visual evoked potentials (mfVEP would be sensitive to any alteration of the neural function induced by omega-3 fatty acid supplementation, because the higher order kernel responses directly measure the degree of recovery of the neural system as a function of time following stimulation. Twenty-two healthy participants aged 18-34, with no known neurological or psychiatric disorder and not currently taking any nutritional supplementation, were recruited. A double-blind, crossover design was utilized, including a 30-day washout period, between two 30-day supplementation periods of the EPA-rich and DHA-rich diets (with order of diet randomized. Psychophysical choice reaction times and multi-focal nonlinear visual evoked potential (VEP testing were performed at baseline (No Diet, and after each supplementation period. Following the EPA-rich supplementation, for stimulation at high luminance contrast, a significant reduction in the amplitude of the first slice of the second order VEP kernel response, previously related to activation in the magnocellular pathway, was observed. The correlations between the amplitude changes of short latency second and first order components were significantly different for the two supplementations. Significantly faster choice reaction times were observed psychophysically (compared with baseline performance under the EPA-rich (but not DHA-rich supplementation, while simple reaction times were not affected. The reduced nonlinearities observed under the

  4. Ambient temperature and risk of cardiovascular events at labor and delivery: A case-crossover study.

    Science.gov (United States)

    Ha, Sandie; Nguyen, Kelly; Liu, Danping; Männistö, Tuija; Nobles, Carrie; Sherman, Seth; Mendola, Pauline

    2017-11-01

    Extreme ambient temperatures are linked to cardiac events in the general population, but this relationship is unclear among pregnant women. We estimated the associations and attributable risk between ambient temperature and the risk of cardiovascular event at labor/delivery, and investigated whether these associations vary by maternal race/ethnicity. We identified 680 women with singleton deliveries affected by cardiovascular events across 12 US sites (2002-2008). Average daily temperature during the week before, delivery day, and each of the seven days before delivery was estimated for each woman. In a case-crossover analysis, exposures during these hazard periods were compared to two control periods before and after delivery using conditional logistic regression adjusted for other environmental factors. During the cold season (October-April), 1°C lower during the week prior to delivery was associated with a 4% (95% CI: 1-7%) increased risk of having a labor/delivery affected by cardiovascular events including cardiac arrest and stroke. During the warm season (May-September), 1°C higher during the week prior was associated with a 7% (95% CI: 3-12%) increased risk. These risks translated to 13.4 and 23.9 excess events per 100,000 singleton deliveries during the cold and warm season, respectively. During the warm season, the risks were more pronounced on days closer to delivery and Black women appeared to be more susceptible to the same temperature increase. Small changes in temperature appear to affect the risk of having cardiovascular events at labor/delivery. Black women had a differentially higher warm season risk. These findings merit further investigation. Published by Elsevier Inc.

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

    NARCIS (Netherlands)

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

    2001-01-01

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

  6. Weather as a risk factor for epileptic seizures: A case-crossover study.

    Science.gov (United States)

    Rakers, Florian; Walther, Mario; Schiffner, Rene; Rupprecht, Sven; Rasche, Marius; Kockler, Michael; Witte, Otto W; Schlattmann, Peter; Schwab, Matthias

    2017-07-01

    Most epileptic seizures occur unexpectedly and independently of known risk factors. We aimed to evaluate the clinical significance of patients' perception that weather is a risk factor for epileptic seizures. Using a hospital-based, bidirectional case-crossover study, 604 adult patients admitted to a large university hospital in Central Germany for an unprovoked epileptic seizure between 2003 and 2010 were recruited. The effect of atmospheric pressure, relative air humidity, and ambient temperature on the onset of epileptic seizures under temperate climate conditions was estimated. We found a close-to-linear negative correlation between atmospheric pressure and seizure risk. For every 10.7 hPa lower atmospheric pressure, seizure risk increased in the entire study population by 14% (odds ratio [OR] 1.14, 95% confidence interval [CI] 1.01-1.28). In patients with less severe epilepsy treated with one antiepileptic medication, seizure risk increased by 36% (1.36, 1.09-1.67). A high relative air humidity of >80% increased seizure risk in the entire study population by up to 48% (OR 1.48, 95% CI 1.11-1.96) 3 days after exposure in a J-shaped association. High ambient temperatures of >20°C decreased seizure risk by 46% in the overall study population (OR 0.54, 95% CI 0.32-0.90) and in subgroups, with the greatest effects observed in male patients (OR 0.33, 95% CI 0.14-0.74). Low atmospheric pressure and high relative air humidity are associated with an increased risk for epileptic seizures, whereas high ambient temperatures seem to decrease seizure risk. Weather-dependent seizure risk may be accentuated in patients with less severe epilepsy. Our results require further replication across different climate regions and cohorts before reliable clinical recommendations can be made. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

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

    Science.gov (United States)

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

    2017-09-01

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

  8. 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.

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

    National Research Council Canada - National Science Library

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

    2011-01-01

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

  11. Psychological Factors and Pain Exacerbation in Knee Osteoarthritis : A Web Based Case-Crossover Study

    NARCIS (Netherlands)

    Erfani, Tahereh; Keefe, Francis; Bennell, Kim; Chen, J; Makovey, J; Metcalf, B; Williams, A.D.; Zhang, Y; Hunter, David

    2015-01-01

    OBJECTIVES: The pain experienced by osteoarthritis (OA) patients is neither constant nor unchanging and patients experience episodes of pain exacerbations. Using an innovative web based case-crossover design, we evaluated whether psychological factors are risk factors for pain exacerbations in

  12. Comparative Studies for What?

    Directory of Open Access Journals (Sweden)

    Pedro Guedes de Carvalho

    2017-12-01

    Full Text Available ISCPES stands for International Society for Comparative Physical Education and Sports and it is going to celebrate its 40th anniversary in 2018. Since the beginning (Israel 1978 the main goals of the Society were established under a worldwide mind set considering five continents and no discrimination of any kind. The founders wanted to compare Physical Education and Sports across the world, searching for the best practices deserving consideration and applied on the purpose of improving citizen quality of life. The mission still stands for “Compare to learn and improve”. As all the organizations lasting for 39 years, ISCPES experienced several vicissitudes, usually correlated with world economic cycles, social and sports changes, which are in ISS journal articles - International Sport Studies. ISS journal is Scopus indexed, aiming to improve its quality (under evaluation to reach more qualified students, experts, professionals and researchers; doing so it will raise its indexation, which we know it is nowadays a more difficult task. First, because there are more journals trying to compete on this academic fierce competitive market; secondly, because the basic requirements are getting more and more hard to gather in the publishing environment around Physical Education and Sports issues. However, we can promise this will be one of our main strategic goals. Another goal I would like to address on this Editorial is the language issue. We have this second strategic goal, which is to reach most of languages spoken in different continents; besides the English language, we will reach Chinese, Spanish and Portuguese speaking countries. For that reason, we already defined that all the abstracts in English will be translated into Chinese, Spanish and Portuguese words so people can find them on any search browser. That will expand the demand for our journal and articles, increasing the number of potential readers. Of course this opportunity, given by

  13. Prenatal tobacco use and risk of stillbirth: a case-control and bidirectional case-crossover study.

    Science.gov (United States)

    Salihu, Hamisu M; Sharma, Puza P; Getahun, Darios; Hedayatzadeh, Maryam; Peters, Shillena; Kirby, Russell S; Alio, Amina P; Gaafer-Ahmed, Hany

    2008-01-01

    We sought to estimate the association between prenatal smoking and stillbirth in a longitudinal cohort using two study designs: a case-control study and a bidirectional case-crossover study. The analysis was conducted using the Missouri maternally linked cohort dataset from 1978 through 1997. In the case-control study, each mother contributed only one birth to the analysis. For the bidirectional crossover design, analysis was restricted to women who gave birth to at least one stillbirth, and the controls comprised all live births before and after the stillbirth. The independent association between prenatal smoking and stillbirth was computed using nonconditional (case-control design) and conditional (bidirectional case-crossover design) logistic regression. Prenatal smoking decreased from 29.7% in 1978 to 21.2% by 1997 (prisk of stillbirth was greater among smokers (7.7/1000) than nonsmokers (5.3/1000), prisk of stillbirth was 34% greater among smokers than nonsmokers (OR = 1.34, 95% CI 1.26-1.43). For each 10-unit increase in the number of cigarettes consumed per day prenatally, the likelihood of stillbirth rose by about 14% (pstillbirth and smoking during pregnancy was confirmed, although the magnitude of the relationship was smaller (OR = 1.20, 95% CI 1.03-1.39). In conclusion, we found prenatal smoking to be a risk factor for stillbirth even after minimizing the influence of known and unknown sources of confounding as well as changes in temporal trend in prenatal smoking.

  14. Osteopathic manipulative treatment results in sustained relief from spinal pain in older patients: A pilot crossover study

    Directory of Open Access Journals (Sweden)

    Pannunzio A

    2016-01-01

    Full Text Available Osteopathic Manipulative Treatment is commonly used to complement conventional treatment of back pain. The present study verified whether OMT, associated with training program, reduces spinal pain in older. A pilot randomized, double-blind crossover study was conducted at Sport Association of Milan, Italy. We recruited 19 subjects above 60 years old, with presence of SP for more than 3 weeks and with intensity score higher than 3 (NRS score. All patients underwent a multi-component group exercise program for older adults and were randomized in two groups: in the study group (SG OMT was added, while the control group (CG continued with the exercise only. After 6 weeks a crossover was applied to the 2 groups and OMT was added to CG, while SG continued with the exercise only. Self-reported measures: the Numeric Rating Scale (NRS was used at each time to evaluate treatment outcomes. At pre-crossover, SG had a significant improvement in pain perception (p<0.05, while CG had a not significate improvement in pain perception (p=0.33.At post-crossover, the SG remains relatively stable (p=0.37, while CG after OMT addition have a significant benefit on pain perception (p=0.001. At follow-up, pain improvement is sustained (p=0.32. OMT associated to exercise reduce spinal pain in older patients. Our study suggests that OMT associated to exercise leads to significant improvement on pain relief in patients with chronic SP in a short term and the exercise allows to maintain these improvements for several months

  15. Operations dashboard: comparative study

    Science.gov (United States)

    Ramly, Noor Nashriq; Ismail, Ahmad Zuhairi; Aziz, Mohd Haris; Ahmad, Nurul Haszeli

    2011-10-01

    In this present days and age, there are increasing needs for companies to monitor application and infrastructure health. Apart from having proactive measures to secure their application and infrastructure, many see monitoring dashboards as crucial investment in disaster preparedness. As companies struggle to find the best solution to cater for their needs and interest for monitoring their application and infrastructure's health, this paper summarizes the studies made on several known off-the-shelf operations dashboard and in-house developed dashboard. A few criteria of good dashboard are collected from previous studies carried out by several researchers and rank them according to importance and business needs. The finalized criteria that will be discussed in later sections are data visualization, performance indicator, dashboard personalization, audit capability and alert/ notification. Comparative studies between several popular dashboards were then carried out to determine whether they met these criteria that we derived from the first exercise. The findings hopefully can be used to educate and provide an overview of selecting the best IT application and infrastructure operations dashboard that suit business needs, thus become the main contribution of this paper.

  16. A Case–Crossover Study of Wintertime Ambient Air Pollution and Infant Bronchiolitis

    Science.gov (United States)

    Karr, Catherine; Lumley, Thomas; Shepherd, Kristen; Davis, Robert; Larson, Timothy; Ritz, Beate; Kaufman, Joel

    2006-01-01

    We examined the association of infant bronchiolitis with acute exposure to ambient air pollutants. Design We employed a time-stratified case–crossover method and based the exposure windows on a priori, biologically based hypotheses. Participants We evaluated effects in 19,901 infants in the South Coast Air Basin of California in 1995–2000 with a hospital discharge record for bronchiolitis in the first year of life (International Classification of Diseases, 9th Revision, CM466.1). Evaluations/Measurements Study subjects’ ZIP code was linked to ambient air pollution monitors to derive exposures. We estimated the risk of bronchiolitis hospitalization associated with increases in wintertime ambient air pollutants using conditional logistic regression. Results We observed no increased risk after acute exposure to particulate matter ≤ 2.5 μm in aerodynamic diameter (PM2.5), carbon monoxide, or nitrogen dioxide. PM2.5 exposure models suggested a 26–41% increased risk in the most premature infants born at gestational ages between 25 and 29 weeks; however, these findings were based on very small numbers. Conclusions We found little support for a link between acute increases in ambient air pollution and infant bronchiolitis except modestly increased risk for PM2.5 exposure among infants born very prematurely. In these infants, the periods of viral acquisition and incubation concurred with the time of increased risk. Relevance to Professional Practice We present novel data for the infant period and the key respiratory disease of infancy, bronchiolitis. Incompletely explained trends in rising bronchiolitis hospitalization rates and increasing number of infants born prematurely underscore the importance of evaluating the impact of ambient air pollution in this age group in other populations and studies. PMID:16451867

  17. Crossover study of the effect of coffee consumption on simulated laparoscopy skills.

    Science.gov (United States)

    Quan, V; Alaraimi, B; Elbakbak, W; Bouhelal, A; Patel, B

    2015-02-01

    To observe the effect of caffeine on performing laparoscopic skills in novices in a simulated setting. Coffee is consumed almost ubiquitously by surgeons not just as a stimulant but also socially in the well-rested individual. It's therefore worth investigating its potentially negative effect on performance of surgical skills as it is known that coffee has psychomotor effects. This is a single-blind crossover study in which 31 novices were tested under three different conditions: decaffeinated, 100 mg caffeine and 200 mg caffeine. Candidates were asked to perform 3 repetitions of task 3, 6, 7 and 8 using the Lap Mentor™ (Simbionix(®)). Outcomes measured were completion time, accuracy, number of movements and total path length. The candidates were crossed over to the other caffeine doses on a different day. 20 candidates completed the study, mean age 21.3 years, with 10 males and 10 females. Candidates performed tasks 7 and 8 faster in the decaffeinated group than the caffeinated groups with significant differences between decaffeinated and 100 mg caffeine (p-value = 0.001, 0.019 respectively) and decaffeinated and 200 mg in task 8(p-value = 0.042). Total path length was significantly less in the decaffeinated group in tasks 7 and 8 and total number of movements was less in tasks 3, 7 and 8. Caffeine had no marked effect on accuracy, but had a negative effect on task economy (hand movements, total path length and completion time). Copyright © 2015 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

  18. Placebo-controlled cross-over study of effects of Org OD 14 in menopausal women.

    Science.gov (United States)

    Kicovic, P M; Cortés-Prieto, J; Luisi, M; Milojevic, S; Franchi, F

    1982-01-01

    A double-blind cross-over study with Org OD 14 and placebo was performed in 82 menopausal patients presenting with hot flushes and associated symptoms. Patients were randomly allocated to Org OD 14 or placebo as first treatment, and switched to placebo or Org OD 14 as second treatment. Each treatment period lasted for 16 weeks; no wash-out period was introduced. Tablets containing 2.5 mg of Org OD 14 or matched placebo tablets were supplied. Data on the following variables were obtained and analysed by the non-parametric randomization test for paired observations: hot flushes, sweating, dizziness, palpitations, fatiguability, headache, sleeplessness, irritability, breathlessness, backache and loss of libido and, in 16 patients, on circulating levels of FSH, LH, PRL, T3, T4, cortisol (F), SHBG, TBG and CBG. Twenty patients (13 placebo, 7 Org OD 14) withdrew, because their symptoms did not improve and one patient withdrew for reasons unrelated to treatment, so that 61 patients completed the study. The data demonstrated a good clinical effect and statistically significant differences in favour of Org OD 14 for hot flushes and a number of associated symptoms. Many patients reported on a general feeling of well being and a mood-elevating effect following Org OD 14. Org OD 14 significantly suppressed FSH and LH levels, while those of PRL remained unchanged. Although there was slight suppression of TBG and T4 which attained statistical significance, there was no influence on the most important parameter, T3. SHBG levels were slightly suppressed, whereas F and CBG levels were unaffected.

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

    Science.gov (United States)

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

    2017-06-01

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

  20. 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.

  1. Acute effect of oatmeal on subjective measures of appetite and satiety compared to a ready-to-eat breakfast cereal: a randomized crossover trial.

    Science.gov (United States)

    Rebello, Candida J; Johnson, William D; Martin, Corby K; Xie, Wenting; O'Shea, Marianne; Kurilich, Anne; Bordenave, Nicolas; Andler, Stephanie; van Klinken, B Jan Willem; Chu, Yi-Fang; Greenway, Frank L

    2013-01-01

    The physicochemical properties of soluble oat fiber (β-glucan) affect viscosity-dependent mechanisms that influence satiety. The objective of this study was to compare the satiety impact of oatmeal with the most widely sold ready-to-eat breakfast cereal (RTEC) when either was consumed as a breakfast meal. Forty-eight healthy individuals ≥18 years of age were enrolled in a randomized crossover trial. Following an overnight fast, subjects consumed either oatmeal or RTEC in random order at least a week apart. The breakfasts were isocaloric and contained 363 kcal (250 kcal cereal, 113 kcal milk). Visual analogue scales measuring appetite and satiety were completed before breakfast and throughout the morning. The content and physicochemical properties of oat β-glucan were determined. Appetite and satiety responses were analyzed by area under the curve (AUC). Physicochemical properties were analyzed using t tests. Oatmeal, higher in fiber and protein but lower in sugar than the RTEC, resulted in greater increase in fullness (AUC: p = 0.005 [120 minute: p = 0.0408, 180 minute: p = 0.0061, 240 minute: p = 0.0102]) and greater reduction in hunger (AUC: p = 0.0009 [120 minute: p = 0.0197, 180 minute: p = 0.0003, 240 minute: p = 0.0036]), desire to eat (AUC: p = 0.0002 [120 minute: p = 0.0168, 180 minute: p Oatmeal had higher β-glucan content, higher molecular weight (p Oatmeal improves appetite control and increases satiety. The effects may be attributed to the viscosity and hydration properties of its β-glucan content.

  2. Multiple-joint exercises using elastic resistance bands vs. conventional resistance-training equipment: A cross-over study.

    Science.gov (United States)

    Iversen, Vegard M; Mork, Paul Jarle; Vasseljen, Ottar; Bergquist, Ronny; Fimland, Marius S

    2017-09-01

    Previous studies indicate that elastic resistance bands (ERB) can be a viable option to conventional resistance-training equipment (CRE) during single-joint resistance exercises, but their efficacy has not been established for several commonly used multiple-joint resistance exercises. Thus, we compared muscular activation levels in four popular multiple-joint exercises performed with ERB (TheraBand(®)) vs. CRE (Olympic barbell or cable pulley machines). In a cross-over design, men and women (n = 29) performed squats, stiff-legged deadlifts, unilateral rows and lateral pulldown using both modalities. Multilevel mixed-effects linear regression analyses of main and interaction effects, and subsequent post hoc analyses were used to assess differences between the two resistance-training modalities. CRE induced higher levels of muscle activation in the prime movers during all exercises (p rows and for the erector spinae during stiff-legged deadlifts. In squats the quadriceps femoris activations were substantially lower for ERB. The differences between ERB and CRE were mostly observed during the parts of the contractions where the bands were relatively slack, whilst the differences were largely eliminated when the bands became elongated in the end ranges of the movements. We conclude that ERB can be a feasible training modality for lateral pulldowns, unilateral rows and to some extent stiff-legged deadlifts, but not for the squat exercise.

  3. [Capacity analysis of health food choice by reference to consumers in two models of nutritional labeling; crossover study].

    Science.gov (United States)

    Babio, Nancy; López, Leonor; Salas-Salvadó, Jordi

    2013-01-01

    The aim of this study was to compare two models of nutrition labeling front-of-pack, in reference to the ability of consumers to choose a diet closer to nutritional recommendations. Randomized crossover design in 32 adults (18-65 years) of both sexes. Participants were randomly exposed to two experimental conditions using nutritional traffic light system (S-SN) or monochrome system (SM). Participants had to choose options from a closed menu for five days on the basis of the experimental front-of-pack labelling. For each meal, three food options with different nutritional compositions were given to the participants. The total energy and fat, saturated fat, sugar and salt of the chosen options were calculated. No significant differences at baseline sociodemographic and anthropometric characteristics were shown between individuals regardless of the experimental condition in which they started. The subjects tended to choose a diet with a lower, but not significant energy content of 23.0 ± 67.5 (P = 0.063) and a significantly lower sugar content of 3.5 ± 9.2 g, P traffic-light system probably can help make food choices with less sugar and salt in a situation similar to the usual purchase in which there is a time limitation. Copyright © AULA MEDICA EDICIONES 2013. Published by AULA MEDICA. All rights reserved.

  4. A randomised, open-label, crossover study of the dopamine agonist, pramipexole, in patients with sleep bruxism.

    Science.gov (United States)

    Cahlin, Birgitta Johansson; Hedner, Jan; Dahlström, Lars

    2017-02-01

    Sleep bruxism bears several similarities to restless legs syndrome, and a link to changes in central dopamine activity has been considered in both conditions. The dopamine agonist pramipexole is currently indicated for the symptomatic treatment of restless legs. The effect of pramipexole on sleep bruxism was investigated in subjects with 'probable bruxism' recruited at the Orofacial Pain Clinic. Thirteen patients underwent polysomnographic recordings, including bilateral masseter electromyographic activity. Following habituation to the recording equipment, a baseline registration was used to confirm bruxism [total episodes per hour, mean 11.3 (6.3)]. Following randomisation, subjects received no treatment or pramipexole titrated from 0.09 to 0.54 mg, o.d., for 3 weeks according to a crossover procedure. A polysomnographic-electromyographic registration was performed at the end of each period. Pramipexole was associated with more frequent awakenings and a reduction in rapid eye movement sleep (both P ≤ 0.02). Sleep apnea decreased marginally after pramipexole (apnea-hypopnea index 17.1 compared with control 21.5, P ≤ 0.05). The number of bruxism episodes, phasic, tonic and mixed per hour, remained unchanged after pramipexole [total episodes per hour 12.7 (8.5) and 9.8 (5.2) during pramipexole and control conditions, respectively]. It is concluded, from this pilot study, that sleep bruxism is not affected by the dopaminergic agent, pramipexole. © 2016 European Sleep Research Society.

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

    Science.gov (United States)

    Hammami, Muhammad M; Alvi, Syed N

    2017-09-01

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

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

    Science.gov (United States)

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

    2017-02-01

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

  7. Association between medication and intestinal intussusception in children: a case-crossover study.

    Science.gov (United States)

    Vega García, Lourdes; Fuentes-Leonarte, Virginia; Tenías, José María; Correcher Medina, Patricia; Arias Arias, Ángel; Román Ortiz, Carmen

    2015-04-01

    This study aimed to assess the association between the appearance of intussusception in children and medication intake in the immediately preceding period (2-15 days). A case-crossover design was used. We selected cases of children admitted with a diagnosis of intussusception (International Classification of Diseases, Ninth Revision, 860) to the major hospitals in the city of Valencia, Spain, from 2006 to 2009. We then estimated the association between the episode of intussusception and the intake of prescription medication during the preceding 2, 7, and 15 days (case period) and for the same time window 1, 2, 3, and 4 months prior (control period). Data on previous drug administration were obtained from the Pharmaceutical Service Manager System. A total of 95 cases (65.3% boys and 34.7% girls) were selected; 76.6% were younger than the age of 2 years. The association between intussusception and prior drug use varied depending on the exposure window: 15-day odds ratio (OR), 1.45 (95% confidence interval [95% CI], 0.86-2.43); 7-day OR, 1.46 (95% CI, 0.80-2.67); and 2-day OR, 2.26 (95% CI, 1.10-4.64). These associations were greater for children aged younger than 2 years and were usually due to the recent administration (preceding 2 days) of antibiotics (OR, 8.00; 95% CI, 1.47-43.7). Intussusception was more common among boys aged younger than 2 years. A positive and significant association was observed when drugs were administered 2 to 7 days before the onset of symptoms in children younger than the age of 2 years.

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

    Science.gov (United States)

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

    2014-08-15

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

  9. Case-crossover study to examine the change in postpartum risk of pulmonary embolism over time.

    Science.gov (United States)

    Ficheur, Grégoire; Caron, Alexandre; Beuscart, Jean-Baptiste; Ferret, Laurie; Jung, Yu-Jin; Garabedian, Charles; Beuscart, Régis; Chazard, Emmanuel

    2017-04-14

    Although the current guidelines recommend anticoagulation up until 6 weeks after delivery in women at high risk of venous thromboembolism (VTE), the risk of VTE may extend beyond 6 weeks. Our objective was to estimate the risk of a pulmonary embolism in successive 2-week intervals during the postpartum period. In a population-based, case-crossover study, we analyzed the French national inpatient database from 2007 to 2013 (n = 5,517,680 singleton deliveries). Using ICD-10 codes, we identified women who were diagnosed with a postpartum pulmonary embolism between July 1st, 2008, and December 31st, 2013. Deliveries were identified during a case "period" immediately before the pulmonary embolism, and five different control periods one year before the pulmonary embolism. Using conditional logistic regression, Odds ratios (ORs) and 95% confidential intervals (CIs) were estimated for ten successive 2-week intervals that preceded the diagnosis of pulmonary embolism. We identified 167,103 cases with a pulmonary embolism during the inclusion period. After delivery, the risk of pulmonary embolism declined progressively over time, with an OR [95%CI] of 17.2 [14.0-21.3] in postpartum weeks 1 to 2 and 1.9 [1.4-2.7] in postpartum weeks 11 to 12. The OR [95%CI] in postpartum weeks 13 to 14 was 1.4 [0.9-2.0], and the OR did not fall significantly after postpartum week 14. Our findings indicate that women are at risk of a pulmonary embolism up to 12 weeks after delivery. The shape of the risk curve suggests that the risk decreases exponentially over time. Future research is needed to establish whether the duration of postpartum anticoagulation should be extended beyond 6 weeks.

  10. Magnetic studies of Co2+, Ni2+, and Zn2+-modified DNA double-crossover lattices

    Science.gov (United States)

    Dugasani, Sreekantha Reddy; Oh, Young Hoon; Gnapareddy, Bramaramba; Park, Tuson; Kang, Won Nam; Park, Sung Ha

    2018-01-01

    We fabricated divalent-metal-ion-modified DNA double-crossover (DX) lattices on a glass substrate and studied their magnetic characteristics as a function of ion concentrations [Co2+], [Ni2+] and [Zn2+]. Up to certain critical concentrations, the DNA DX lattices with ions revealed discrete S-shaped hysteresis, i.e. characteristics of strong ferromagnetism, with significant changes in the coercive field, remanent magnetization, and susceptibility. Induced magnetic dipoles formed by metal ions in DNA duplex in the presence of a magnetic field imparted ferromagnetic behaviour. By considering hysteresis and the magnitude of magnetization in a magnetization-magnetic field curve, Co2+-modified DNA DX lattices showed a relatively strong ferromagnetic nature with an increasing (decreasing) trend of coercive field and remanent magnetization when [Co2+] ≤ 1 mM ([Co2+] > 1 mM). In contrast, Ni2+ and Zn2+-modified DNA DX lattices exhibited strong and weak ferromagnetic behaviours at lower (≤1 mM for Ni2+ and ≤0.5 mM for Zn2+) and higher (>1 mM for Ni2+ and >0.5 mM for Zn2+) concentrations of ions, respectively. About 1 mM of [Co2+], [Ni2+] and [Zn2+] in DNA DX lattices was of special interest with regard to physical characteristics and was identified to be an optimum concentration of each ion. Finally, we measured the temperature-dependent magnetic characteristics of the metal-ion-modified DNA DX lattices. Nonzero magnetization and inverse susceptibility with almost constant values were observed between 25 and 300 K, with no indication of a magnetic transition. This indicated that the magnetic Curie temperatures of Co2+, Ni2+ and Zn2+-modified DNA DX lattices were above 300 K.

  11. 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

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

    Science.gov (United States)

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

    2016-02-01

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

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

    Science.gov (United States)

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

    2012-04-01

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

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

    Directory of Open Access Journals (Sweden)

    Karen Windey

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

  15. Bean and rice meals reduce postprandial glycemic response in adults with type 2 diabetes: a cross-over study

    Directory of Open Access Journals (Sweden)

    Thompson Sharon V

    2012-04-01

    Full Text Available Abstract Background Around the world, beans and rice are commonly consumed together as a meal. With type 2 diabetes increasing, the effect of this traditional diet pattern on glycemic response has not been studied fully. Methods We evaluated the glycemic response of bean and rice traditional meals compared to rice alone in adults with type 2 diabetes. Seventeen men and women with type 2 diabetes controlled by metformin (n = 14 or diet/exercise (n = 3 aged 35–70 years participated in the randomized 4 × 4 crossover trial. The white long grain rice control, pinto beans/rice, black beans/rice, red kidney beans/rice test meals, matched for 50 grams of available carbohydrate, were consumed at breakfast after a 12 hour fast. Capillary blood glucose concentrations at baseline and at 30 minute intervals up to 180 minutes postprandial were collected. MANOVA for repeated measures established glucose differences between treatments. Paired t tests identified differences between bean types and the rice control following a significant MANOVA. Results Postprandial net glucose values were significantly lower for the three bean/rice treatments in contrast to the rice control at 90, 120 and 150 minutes. Incremental area under the curve values were significantly lower for the pinto and black bean/rice meals compared to rice alone, but not for kidney beans. Conclusions Pinto, dark red kidney and black beans with rice attenuate the glycemic response compared to rice alone. Promotion of traditional foods may provide non-pharmaceutical management of type 2 diabetes and improve dietary adherence with cultural groups. Trial registration Clinical Trials number NCT01241253

  16. Oxygen therapy for cluster headache. A mask comparison trial. A single-blinded, placebo-controlled, crossover study.

    Science.gov (United States)

    Petersen, Anja S; Barloese, Mads Cj; Lund, Nunu Lt; Jensen, Rigmor H

    2017-03-01

    Purpose The purpose of this article is to investigate possible differences in effect between three types of masks in the acute treatment of cluster headache (CH). Patients and methods Fifty-seven CH patients according to ICHD-II-criteria participated in a single-blinded, semi-randomized, placebo-controlled, crossover inpatient study, and 102 CH attacks were treated with 100% oxygen delivered by demand valve oxygen (DVO), O2ptimask or simple mask (15 liters/min) or placebo delivered by DVO for 15 minutes. Primary endpoint: Two-point decrease of pain on a five-point rating scale within 15 minutes. Results Only 10 CH patients had multiple attacks and reached the point of placebo. There were no significant differences between masks in the primary endpoints ( p = 0.412). After 15 minutes 48% had a two-point decrease using the DVO compared to 45% with placebo ( p = 0.867). After 30 minutes 68% were pain free or had pain relief using DVO and 45% by placebo ( p = 0.061). The DVO was preferred by 62% compared to 5% and 33% for simple mask ( p Treatment with DVO or O2ptimask reduced the need for rescue medication compared to the simple mask (23%, 19%, 50%, respectively). No treatment-related adverse events were observed. Conclusion The primary endpoint with pain relief at 15 minutes was non-significant; however, a post hoc analysis of the first attack significantly favored DVO. Further, therapy by O2ptimask and DVO resulted in a decreased need for rescue medication. We recommend that CH patients be offered DVO or O2ptimask before oxygen therapy is abandoned.

  17. Comparative Studies for What?

    OpenAIRE

    Pedro Guedes de Carvalho

    2017-01-01

    ISCPES stands for International Society for Comparative Physical Education and Sports and it is going to celebrate its 40th anniversary in 2018. Since the beginning (Israel 1978) the main goals of the Society were established under a worldwide mind set considering five continents and no discrimination of any kind. The founders wanted to compare Physical Education and Sports across the world, searching for the best practices deserving consideration and applied on the purpose of improving citiz...

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

    Science.gov (United States)

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

    2015-11-01

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

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

    Science.gov (United States)

    Safarinejad, Mohammad Reza

    2005-01-01

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

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

    Science.gov (United States)

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

    2014-01-01

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

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

    Science.gov (United States)

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

    2013-05-01

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

  2. Flooding and emergency room visits for gastrointestinal illness in Massachusetts: a case-crossover study.

    Directory of Open Access Journals (Sweden)

    Timothy J Wade

    Full Text Available INTRODUCTION: Floods and other severe weather events are anticipated to increase as a result of global climate change. Floods can lead to outbreaks of gastroenteritis and other infectious diseases due to disruption of sewage and water infrastructure and impacts on sanitation and hygiene. Floods have also been indirectly associated with outbreaks through population displacement and crowding. METHODS: We conducted a case-crossover study to investigate the association between flooding and emergency room visits for gastrointestinal illness (ER-GI in Massachusetts for the years 2003 through 2007. We obtained ER-GI visits from the State of Massachusetts and records of floods from the National Oceanic and Atmospheric Association's Storm Events Database. ER-GI visits were considered exposed if a flood occurred in the town of residence within three hazard periods of the visit: 0-4 days; 5-9 days; and 10-14 days. A time-stratified bi-directional design was used for control selection, matching on day of the week with two weeks lead or lag time from the ER-GI visit. Fixed effect logistic regression models were used to estimate the risk of ER-GI visits following the flood. RESULTS AND CONCLUSIONS: A total of 270,457 ER-GI visits and 129 floods occurred in Massachusetts over the study period. Across all counties, flooding was associated with an increased risk for ER-GI in the 0-4 day period after flooding (Odds Ratio: 1.08; 95% Confidence Interval: 1.03-1.12; but not the 5-9 days (Odds Ratio: 0.995; 95% Confidence Interval: 0.955-1.04 or the 10-14 days after (Odds Ratio: 0.966, 95% Confidence Interval: 0.927-1.01. Similar results were observed for different definitions of ER-GI. The effect differed across counties, suggesting local differences in the risk and impact of flooding. Statewide, across the study period, an estimated 7% of ER-GI visits in the 0-4 days after a flood event were attributable to flooding.

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

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    Boyer Lauren E

    2012-08-01

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

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

    Science.gov (United States)

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

    2013-01-01

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

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

    Science.gov (United States)

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

    2012-10-16

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

  6. Rehabilitation of Visuospatial Cognition and Visual Exploration in Neglect: a Cross-over Study.

    Science.gov (United States)

    Kerkhoff, Georg

    1998-01-01

    Right hemispheric brain damage is often accompanied by visual neglect of contralesional hemispace as well as profound visuospatial and visuoconstructive disorders. Despite some recent improvements in the treatment of neglect, few therapeutic approaches exist for disorders of visuospatial cognition and none has dealt with the question of how both disorders can be treated in combination. In the present cross-over rehabilitation study, thirteen neglect patients first received visual exploration training for six weeks followed by visuospatial training for four weeks. Eleven patients had a right-hemispheric lesion, 2 a left-hemispheric lesion. Ten subjects had parietal cortical lesions, 3 lesions were outside the parietal lobe. In the first treatment phase the patients received training, using computer controlled devices, intended to improve visual search and reading strategies. In the second phase of treatment, visual orientation discrimination was trained on a PC-monitor with verbal feedback by the therapist. Significant improvements were obtained after exploration training regarding the extent of visual search-field witbin the neglected hemifield, visual search performance in the whole visual field, reading time and reading errors but there was no change after visuospatial training for any of these measures. The reverse pattern was observed for visuospatial training: significant improvements were observed in line orientation judgements, clock perception, mental transposition of angles, horizontal writing and visuoconstructive abilities, but there was no change in any of these tests during exploration training. Feedback-based training of visual orientation discrimination revealed rapid (within 8-15 sessions) and stable improvements in this ability and a transfer to spatially related tasks.No significant correlations were obtained between training-related improvements and the time since brain damage for 9 of 10 tests, indicating that spontaneous recovery had no effect

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

    Science.gov (United States)

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

    2015-01-01

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

  8. Air pollution and emergency department visits for conjunctivitis: A case-crossover study

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    Mieczysław Szyszkowicz

    2016-06-01

    Full Text Available Objectives: The purpose of this study was to examine the associations between emergency department (ED visits for conjunctivitis and ambient air pollution levels in urban regions across the province of Ontario, Canada. Material and Methods: Information from the National Ambulatory Care Reporting System was used to create time-series records, for the period of April 2004 to December 2011, on emergency department visits of patients suffering from conjunctivitis. A total of 77 439 emergency department visits for conjunctivitis were analyzed. A time-stratified case-crossover design was applied, completed with meta-analysis in order to pool inter-city results. Odds ratio (OR for an emergency department visit was calculated in different population strata per one-unit increase (one interquartile range – IQR increase in a pollutant’s daily level while controlling for the impacts of temperature and relative humidity. Results: Statistically significant positive results were observed in the female population sample, for nitrogen dioxide (NO2 exposure lagged 5–8 days, with the highest result for the 7-day lag (OR = 1.035, 95% CI: 1.018–1.052 and for fine particulate matter with a median aerodynamic diameter of less than 2.5 μm (PM2.5, for lags 6 and 7 days, with the highest result for lag 7 (OR = 1.017, 95% CI: 1.003–1.031. In the male population sample, statistically significant positive results were observed for NO2 at lag 5 days (OR = 1.024, 95% CI: 1.004–1.045 and for ozone (O3, at lags 0–3 and 7 days, with the highest result for lag 0 (OR = 1.038, 95% CI: 1.012–1.056. Also for males, statistically significant results were observed in the case of PM2.5 exposure lagged by 5 days (OR = 1.003, 95% CI: 1.000–1.038 and sulfur dioxide (SO2 exposure lagged by 1 and 2 days (OR = 1.016, 95% CI: 1.000–1.031 and OR = 1.018, 95% CI: 1.002–1.033. Conclusions: The findings of this study suggest that there are associations between levels of air

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

    Science.gov (United States)

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

    2014-06-01

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

  10. Pharmacokinetics, pharmacodynamics, and safety of esomeprazole injection/infusion in healthy Chinese volunteers: a five-way crossover study.

    Science.gov (United States)

    Yang, Hong; Li, Jingnan; Zhao, Qian; Li, Ji; Shen, Kai; Yang, Xiaoou; Jiang, Ji; Hu, Pei; Qian, Jiaming

    2013-12-01

    Esomeprazole provides effective and long lasting inhibition of gastric acid secretion. However, the pharmacokinetics and pharmacodynamics of intravenous esomeprazole in the Chinese population remain unclear. To compare the pharmacokinetics and pharmacodynamics of intravenous esomeprazole (injection and infusion) and their clinical safety and tolerability in healthy Chinese subjects. A randomized, single-center, open-label, five-way crossover study was conducted in 20 healthy volunteers. CYP2C19 metabolizer genotype and Helicobacter pylori status were examined. Five dosing regimens were used: single 40 mg injection, 40 mg infusion every 12 h, 40 mg infusion followed by continuous infusion at 8 mg/h, 80 mg infusion followed by continuous infusion at 4 or 8 mg/h. Intragastric pH was recorded within 24 h. Plasma concentration-time curve, maximum plasma concentration (Cmax ), steady state concentration, and total plasma clearance were determined. Adverse events were also recorded. Continuous infusion resulted in a higher mean area under the curve and Cmax than injection. There were no significant differences among the four infusion groups in terms of percentages of time at pH > 4, > 5, > 6, > 7 within 24 h and pH > 6 within the first 3 h. There were no significant differences in pharmacokinetic or pH values among variants of CYP2C19 genotype. The pH value within 24 h was unaffected by H. pylori infection in subjects with continuous infusion. Esomeprazole administrated by infusion produces better pharmacokinetic and intragastric pH profiles compared with those by injection. The optimal administration schedule for esomeprazole in Chinese subjects is infusion with 40 mg/12 h. © 2013 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd.

  11. FS4, FS4-p, and FSP: a 4-month crossover study of 3 fine structure sound-coding strategies.

    Science.gov (United States)

    Riss, Dominik; Hamzavi, Jafar-Sasan; Blineder, Michaela; Honeder, Clemens; Ehrenreich, Isabella; Kaider, Alexandra; Baumgartner, Wolf-Dieter; Gstoettner, Wolfgang; Arnoldner, Christoph

    2014-01-01

    The aim of the present study was to compare two novel fine structure strategies "FS4" and "FS4-p" with the established fine structure processing (FSP) strategy. FS4 provides fine structure information on the apical four-electrode channels. With FS4-p, these electrodes may be stimulated in a parallel manner. The authors evaluated speech perception, sound quality, and subjective preference. A longitudinal crossover study was done on postlingually deafened adults (N = 33) who were using FSP as their default strategy. Each participant was fitted with FS4, FS4-p, and FSP, for 4 months in a randomized and blinded order. After each run, an Adaptive Sentence test in noise (Oldenburger Sentence Test [OLSA]) and a Monosyllable test in quiet (Freiburger Monosyllables) were performed, and subjective sound quality was determined with a Visual Analogue Scale. At the end of the study the preferred strategy was noted. Scores of the OLSA did not reveal any significant differences among the three strategies, but the Freiburger test showed a statistically significant effect (p = 0.03) with slightly worse scores for FS4 (49.7%) compared with FSP (54.3%). Performance of FS4-p (51.8%) was comparable with the other strategies. Both audiometric tests depicted a high variability among subjects. The number of best-performing strategies for each participant individually was as follows: (a) for the OLSA: FSP, N = 10.5; FS4, N = 10.5; and FS4-p, N = 12; and (b) for the Freiburger test: FSP, N = 14; FS4, N = 9; and FS4-p, N = 10. A moderate agreement was found in the best-performing strategies of the Speech tests within the participants. For sound quality, speech in quiet, classical, and pop music were assessed. No significant effects of strategy were found for speech in quiet and classical music, but auditory impression of pop music was rated as more natural in FSP compared with FS4 (p = 0.04). It is interesting that at the end of the study, a majority of the participants favored the new

  12. Topical effect of a medically prescribed pediatric antibiotic on dental biofilm: a cross-over, in situ study.

    Directory of Open Access Journals (Sweden)

    Viviane Santos da Silva Pierro

    Full Text Available OBJECTIVE: This study aimed to investigate the possible topical effect of a broad-spectrum antibiotic on dental biofilm formed in situ in the absence or presence of sucrose. METHODS: A crossover study was conducted in three phases of 14 days each, during which 11 volunteers wore palatal devices containing 6 enamel blocks covered with meshes to allow biofilm formation. Dental blocks were extraorally submitted to a 20% sucrose solution at three different frequencies of exposure (0, 3 and 8 times/day, and to a suspension of amoxicillin/clavulanate potassium (A/CP or a placebo (P suspension at an 8-hour time interval application regimen. On the 14(th day of each phase, biofilms were collected for microbiological (conventional culture and molecular (Denaturing Gradient Gel Electrophoresis--DGGE analyses. RESULTS: In the absence of sucrose exposure (SE and at the 3-time daily frequency, dental biofilms treated with A/CP showed lower total biofilm weight and lower counts of total microbiota than the ones treated with P (p>0.05. A/CP presented higher counts of Candida spp. when compared with P in the presence of SE, especially at the 8-time daily frequency (p0.05, regardless of SE. However, DGGE profiles demonstrated large interindividual variability. CONCLUSION: Both conventional culture and DGGE have demonstrated some differences on total microbiota of dental biofilms when exposed to the A/CP or P suspensions, mainly in the absence of sucrose, which suggests a possible topical effect of the sugar-free A/CP suspension on dental biofilm.

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

    Science.gov (United States)

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

    2015-04-01

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

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

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

    2016-11-01

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

  15. Topical effect of a medically prescribed pediatric antibiotic on dental biofilm: a cross-over, in situ study.

    Science.gov (United States)

    Pierro, Viviane Santos da Silva; Ferreira, Dennis de Carvalho; de Jesus, Hugo Emiliano; Rosado, Alexandre Soares; Luiz, Ronir Raggio; dos Santos, Kátia Regina Netto; Maia, Lucianne Cople

    2013-01-01

    This study aimed to investigate the possible topical effect of a broad-spectrum antibiotic on dental biofilm formed in situ in the absence or presence of sucrose. A crossover study was conducted in three phases of 14 days each, during which 11 volunteers wore palatal devices containing 6 enamel blocks covered with meshes to allow biofilm formation. Dental blocks were extraorally submitted to a 20% sucrose solution at three different frequencies of exposure (0, 3 and 8 times/day), and to a suspension of amoxicillin/clavulanate potassium (A/CP) or a placebo (P) suspension at an 8-hour time interval application regimen. On the 14(th) day of each phase, biofilms were collected for microbiological (conventional culture) and molecular (Denaturing Gradient Gel Electrophoresis--DGGE) analyses. In the absence of sucrose exposure (SE) and at the 3-time daily frequency, dental biofilms treated with A/CP showed lower total biofilm weight and lower counts of total microbiota than the ones treated with P (p>0.05). A/CP presented higher counts of Candida spp. when compared with P in the presence of SE, especially at the 8-time daily frequency (p0.05), regardless of SE. However, DGGE profiles demonstrated large interindividual variability. Both conventional culture and DGGE have demonstrated some differences on total microbiota of dental biofilms when exposed to the A/CP or P suspensions, mainly in the absence of sucrose, which suggests a possible topical effect of the sugar-free A/CP suspension on dental biofilm.

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

    Science.gov (United States)

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

    2017-01-01

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

  17. Lack of adjustment latitude at work as a trigger of taking sick leave-a Swedish case-crossover study.

    Directory of Open Access Journals (Sweden)

    Hanna Hultin

    Full Text Available OBJECTIVES: Research has shown that individuals reporting a low level of adjustment latitude, defined as having few possibilities to temporarily adjust work demands to illness, have a higher risk of sick leave. To what extent lack of adjustment latitude influences the individual when making the decision to take sick leave is unknown. We hypothesize that ill individuals are more likely to take sick leave on days when they experience a lack of adjustment latitude at work than on days with access to adjustment latitude. METHODS: A case-crossover design was applied to 546 sick-leave spells, extracted from a cohort of 1 430 employees at six Swedish workplaces, with a 3-12 month follow-up of all new sick-leave spells. Exposure to lack of adjustment latitude on the first sick-leave day was compared with exposure during several types of control periods sampled from the previous two months for the same individual. RESULTS: Only 35% of the respondents reported variations in access to adjustment latitude, and 19% reported a constant lack of adjustment latitude during the two weeks prior to the sick-leave spell. Among those that did report variation, the risk of sick leave was lower on days with lack of adjustment latitude, than on days with access (Odds Ratio 0.36, 95% Confidence Interval 0.25-0.52. CONCLUSIONS: This is the first study to show the influence of adjustment latitude on the decision to take sick leave. Among those with variations in exposure, lack of adjustment latitude was a deterrent of sick leave, which is contrary to the à priori hypothesis. These results indicate that adjustment latitude may not only capture long-lasting effects of a flexible working environment, but also temporary possibilities to adjust work to being absent. Further studies are needed to disentangle the causal mechanisms of adjustment latitude on sick-leave.

  18. Ambient Ozone Concentrations and the Risk of Perforated and Nonperforated Appendicitis: A Multicity Case-Crossover Study

    Science.gov (United States)

    Tanyingoh, Divine; Dixon, Elijah; Johnson, Markey; Wheeler, Amanda J.; Myers, Robert P.; Bertazzon, Stefania; Saini, Vineet; Madsen, Karen; Ghosh, Subrata; Villeneuve, Paul J.

    2013-01-01

    Background: Environmental determinants of appendicitis are poorly understood. Past work suggests that air pollution may increase the risk of appendicitis. Objectives: We investigated whether ambient ground-level ozone (O3) concentrations were associated with appendicitis and whether these associations varied between perforated and nonperforated appendicitis. Methods: We based this time-stratified case-crossover study on 35,811 patients hospitalized with appendicitis from 2004 to 2008 in 12 Canadian cities. Data from a national network of fixed-site monitors were used to calculate daily maximum O3 concentrations for each city. Conditional logistic regression was used to estimate city-specific odds ratios (ORs) relative to an interquartile range (IQR) increase in O3 adjusted for temperature and relative humidity. A random-effects meta-analysis was used to derive a pooled risk estimate. Stratified analyses were used to estimate associations separately for perforated and nonperforated appendicitis. Results: Overall, a 16-ppb increase in the 7-day cumulative average daily maximum O3 concentration was associated with all appendicitis cases across the 12 cities (pooled OR = 1.07; 95% CI: 1.02, 1.13). The association was stronger among patients presenting with perforated appendicitis for the 7-day average (pooled OR = 1.22; 95% CI: 1.09, 1.36) when compared with the corresponding estimate for nonperforated appendicitis [7-day average (pooled OR = 1.02, 95% CI: 0.95, 1.09)]. Heterogeneity was not statistically significant across cities for either perforated or nonperforated appendicitis (p > 0.20). Conclusions: Higher levels of ambient O3 exposure may increase the risk of perforated appendicitis. PMID:23842601

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

    Science.gov (United States)

    Moritz, Andreas; Prottengeier, Johannes; Schmidt, Joachim

    2017-11-01

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

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

    Science.gov (United States)

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

    2015-02-14

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

  1. Effects of a Novel Neurodynamic Tension Technique on Muscle Extensibility and Stretch Tolerance: A Counterbalanced Cross-Over Study.

    Science.gov (United States)

    Pietrzak, M; Vollaard, N B J

    2016-12-19

    Neurodynamic tension affects hamstring extensibility and stretch tolerance, and is considered important in hamstring injury management. Neurodynamic tension was postulated to affect segmental muscle extensibility and stretch tolerance, and potentially also demonstrate extra-segmental and contralateral effects. Assess the effects of a novel sciatic-tibial neurodynamic tension technique, the modified long sit slump (MLSS), on segmental, extra-segmental and contralateral muscle extensibility and stretch tolerance. Counterbalanced cross-over study. University research laboratory. Thirteen healthy and active subjects (mean ± SD age 24 ± 8y, BMI 23.1 ± 2.8 kg·m-2). MLSS application (5 seconds, 5 repetitions, 3 sets) on two occasions with a three-week washout period,and either stance or skill leg treated in a counterbalanced manner. Segmental and extra-segmental muscle extensibility were measured utilising passive straight leg raise (PSLR) and prone knee bend (PKB) at pre-, immediately post- and one hour post-intervention. Stretch intensity ratings were measured utilising a simple numerical rating scale (SNRS). MLSS significantly increased PSLR and PKB bilaterally (p < 0.001). The effect for PSLR was greater in the ipsilateral leg compared to the contralateral leg (baseline to one hour post: +9 ± 6° and +5 ± 5° respectively, p < 0.001), but not for PKB (baseline to one hour post: ipsilateral leg +5 ± 5°, contralateral leg +5 ± 4°). For both PSLR and PKB the effect of the first session was retained at the start of the second session 3 weeks later. SNRS data were consistent with increased stretch tolerance. Application of a novel sciatic-tibial neurodynamic tension technique, the MLSS, increases muscle extensibility and stretch tolerance segmentally, extra-segmentally and contra-laterally.

  2. Overnight closed loop insulin delivery (artificial pancreas) in adults with type 1 diabetes: crossover randomised controlled studies

    Science.gov (United States)

    Kumareswaran, Kavita; Harris, Julie; Allen, Janet M; Elleri, Daniela; Xing, Dongyuan; Kollman, Craig; Nodale, Marianna; Murphy, Helen R; Dunger, David B; Amiel, Stephanie A; Heller, Simon R; Wilinska, Malgorzata E; Evans, Mark L

    2011-01-01

    Objective To compare the safety and efficacy of overnight closed loop delivery of insulin (artificial pancreas) with conventional insulin pump therapy in adults with type 1 diabetes. Design Two sequential, open label, randomised controlled crossover, single centre studies. Setting Clinical research facility. Participants 24 adults (10 men, 14 women) with type 1 diabetes, aged 18-65, who had used insulin pump therapy for at least three months: 12 were tested after consuming a medium sized meal and the other 12 after consuming a larger meal accompanied by alcohol. Intervention During overnight closed loop delivery, sensor measurements of glucose were fed into a computer algorithm, which advised on insulin pump infusion rates at 15 minute intervals. During control nights, conventional insulin pump settings were applied. One study compared closed loop delivery of insulin with conventional pump therapy after a medium sized evening meal (60 g of carbohydrates) at 1900, depicting the scenario of “eating in.” The other study was carried out after a later large evening meal (100 g of carbohydrates) at 2030, accompanied by white wine (0.75 g/kg ethanol) and depicted the scenario of “eating out.” Main outcome measures The primary outcome was the time plasma glucose levels were in target (3.91-8.0 mmol/L) during closed loop delivery and a comparable control period. Secondary outcomes included pooled data analysis and time plasma glucose levels were below target (≤3.9 mmol/L). Results For the eating in scenario, overnight closed loop delivery of insulin increased the time plasma glucose levels were in target by a median 15% (interquartile range 3-35%), P=0.002. For the eating out scenario, closed loop delivery increased the time plasma glucose levels were in target by a median 28% (2-39%), P=0.01. Analysis of pooled data showed that the overall time plasma glucose was in target increased by a median 22% (3-37%) with closed loop delivery (Pinsulin may improve overnight

  3. Relationship of Buckling and Knee Injury to Pain Exacerbation in Knee Osteoarthritis: A Web-Based Case-Crossover Study.

    Science.gov (United States)

    Zobel, Isabelle; Erfani, Tahereh; Bennell, Kim L; Makovey, Joanna; Metcalf, Ben; Chen, Jian Sheng; March, Lyn; Zhang, Yuqing; Eckstein, Felix; Hunter, David J

    2016-06-24

    Knee osteoarthritis (OA) is one of the most frequent causes of limited mobility and diminished quality of life. Pain is the main symptom that drives individuals with knee OA to seek medical care and a recognized antecedent to disability and eventually joint replacement. Evidence shows that patients with symptomatic OA experience fluctuations in pain severity. Mechanical insults to the knee such as injury and buckling may contribute to pain exacerbation. Our objective was to examine whether knee injury and buckling (giving way) are triggers for exacerbation of pain in persons with symptomatic knee OA. We conducted a case-crossover study, a novel methodology in which participants with symptomatic radiographic knee OA who have had knee pain exacerbations were used as their own control (self-matched design), with all data collected via the Internet. Participants were asked to log-on to the study website and complete an online questionnaire at baseline and then at regular 10-day intervals for 3 months (control periods)-a total of 10 questionnaires. They were also instructed to go to the website and complete pain exacerbation questionnaires when they experienced an isolated incident of knee pain exacerbation (case periods). A pain exacerbation "case" period was defined as an increase of ≥2 compared to baseline. At each contact the pain exacerbation was designated a case period, and at all other regular 10-day contacts (control periods) participants were asked about knee injuries during the previous 7 days and knee buckling during the previous 2 days. The relationship of knee injury and buckling to the risk of pain exacerbation was examined using conditional logistic regression models. The analysis included 157 participants (66% women, mean age: 62 years, mean BMI: 29.5 kg/m(2)). Sustaining a knee injury was associated with experiencing a pain exacerbation (odds ratio [OR] 10.2, 95% CI 5.4, 19.3) compared with no injury. Knee buckling was associated with experiencing a

  4. Risk of vertebrobasilar stroke and chiropractic care: results of a population-based case-control and case-crossover study.

    Science.gov (United States)

    Cassidy, J David; Boyle, Eleanor; Côté, Pierre; He, Yaohua; Hogg-Johnson, Sheilah; Silver, Frank L; Bondy, Susan J

    2009-02-01

    Population-based, case-control and case-crossover study. To investigate associations between chiropractic visits and vertebrobasilar artery (VBA) stroke and to contrast this with primary care physician (PCP) visits and VBA stroke. Chiropractic care is popular for neck pain and headache, but may increase the risk for VBA dissection and stroke. Neck pain and headache are common symptoms of VBA dissection, which commonly precedes VBA stroke. Cases included eligible incident VBA strokes admitted to Ontario hospitals from April 1, 1993 to March 31, 2002. Four controls were age and gender matched to each case. Case and control exposures to chiropractors and PCPs were determined from health billing records in the year before the stroke date. In the case-crossover analysis, cases acted as their own controls. There were 818 VBA strokes hospitalized in a population of more than 100 million person-years. In those aged VBA stroke in those older than 45 years. Positive associations were found between PCP visits and VBA stroke in all age groups. Practitioner visits billed for headache and neck complaints were highly associated with subsequent VBA stroke. VBA stroke is a very rare event in the population. The increased risks of VBA stroke associated with chiropractic and PCP visits is likely due to patients with headache and neck pain from VBA dissection seeking care before their stroke. We found no evidence of excess risk of VBA stroke associated chiropractic care compared to primary care.

  5. Dose response of umeclidinium administered once or twice daily in patients with COPD: a randomised cross-over study.

    Science.gov (United States)

    Church, Alison; Beerahee, Misba; Brooks, Jean; Mehta, Rashmi; Shah, Palvi

    2014-01-06

    Umeclidinium bromide (UMEC) is an inhaled long-acting muscarinic antagonist in development for chronic obstructive pulmonary disease (COPD). This was a multicentre, randomised, double-blind, placebo-controlled, three-way cross-over, incomplete block study to evaluate UMEC 15.6, 31.25, 62.5, and 125 μg administered once daily (QD), and UMEC 15.6 μg and 31.25 μg administered twice daily (BID), over 7 days in patients with COPD. Tiotropium was included as an open-label treatment arm. The primary efficacy endpoint was trough forced expiratory volume in 1 second (FEV1) on Day 8. Secondary efficacy endpoints included weighted mean FEV1 over 0-24 hours after morning dosing on Day 7, and serial FEV1 at each time point over 24 hours after morning dosing on Day 7. Safety and pharmacokinetics were also examined. One hundred and sixty-three patients (mean age 59.5 years, 52% female) were randomised. Based on the population dose-response model of trough FEV1 data, the geometric mean potency (ED50) of UMEC was 37 μg (95% confidence interval [CI]: 18, 57) with a predicted maximum intrinsic efficacy (Emax) at trough of 0.185 L (95% CI: 0.153, 0.218) after QD dosing. UMEC 125 μg QD demonstrated the greatest improvements in measure of lung function compared with doses of 62.5 μg and below. UMEC 125 μg QD exhibited more consistent increases in FEV1 from baseline across serial time points over 24 hours compared with other UMEC doses and tiotropium. Increases in FEV1 over 0-12 hours were similar to those observed over 12-24 hours after the second dose of UMEC was administered. UMEC was rapidly absorbed following inhaled dosing and eliminated from plasma. Adverse events, generally mild, were highest with UMEC 125 μg QD (18%) compared with placebo (8%), tiotropium (4%) and other UMEC doses (5-12%). UMEC is a potent QD bronchodilator with geometric mean ED50 of 37 μg. A dose ordering over the range of UMEC 15.6-125 μg QD doses was observed, with UMEC 125 μg showing the greatest

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

    Science.gov (United States)

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

    2014-09-01

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

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

    Science.gov (United States)

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

    2014-06-01

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

  8. Safety of a new extensively hydrolysed formula in children with cow's milk protein allergy: a double blind crossover study

    Directory of Open Access Journals (Sweden)

    Schaafsma Anne

    2002-10-01

    Full Text Available Abstract Background Formulae for infants with cow's milk protein allergy (CMA should be based on extensively hydrolysed protein. 'Extensively' however is not strictly defined. Differences in molecular weight and peptide chain length may affect its clinical outcome. We studied the safety of a new extensively hydrolysed casein based formula (Frisolac Allergycare®: FAC for children with IgE mediated CMA. Methods Thirty children, aged 1.5 – 14.8 years old (median 4.9 years with persistent CMA were enrolled in this double-blind reference product (Nutramigen®: NUT controlled crossover study. All had positive skin prick tests (SPT and IgE mediated allergy, showing immediate reactions after ingestion of small amounts of milk. Twenty-five children also had positive radio allergen sorbent tests (RAST to cow's milk. Formulae provided consisted of 80% elementary formula in combination with 20% reference or test product. Crossover periods lasted for two weeks. From both products molecular weight (MALDI-TOF method and HPLC and peptide chain length distribution (adapted Edman degradation were determined. Results Maximum molecular weights of NUT and FAC are 2.1 and 2.56 kDa, respectively. The contribution of free amino acids and small peptides Conclusions The new extensively hydrolysed casein-based formula (FAC can safely be used in children with IgE mediated cow's milk allergy.

  9. The association between daily concentrations of air pollution and visits to a psychiatric emergency unit: a case-crossover study.

    Science.gov (United States)

    Oudin, Anna; Åström, Daniel Oudin; Asplund, Peter; Steingrimsson, Steinn; Szabo, Zoltan; Carlsen, Hanne Krage

    2018-01-10

    Air pollution is one of the leading causes of mortality and morbidity worldwide. Experimental studies, and a few epidemiological studies, suggest that air pollution may cause acute exacerbation of psychiatric disorders, and even increase the rate of suicide attempts, but epidemiological studies on air pollution in association with psychiatric disorders are still few. Our aim was to investigate associations between daily fluctuations in air pollution concentrations and the daily number of visits to a psychiatric emergency unit. Data from Sahlgrenska University Hospital, Gothenburg, Sweden, on the daily number of visits to the Psychiatric emergency unit were combined with daily data on monitored concentrations of respirable particulate matter(PM 10 ), ozone(O 3 ), nitrogen dioxides(NO 2 ) and temperature between 1st July 2012 and 31st December 2016. We used a case-crossover design to analyze data with conditional Poisson regression models allowing for over-dispersion. We stratified data on season. Visits increased with increasing PM 10 levels during the warmer season (April to September) in both single-pollutant and two-pollutant models. For example, an increase of 3.6% (95% Confidence Interval, CI, 0.4-7.0%) was observed with a 10 μg/m3 increase in PM 10 adjusted for NO 2 . In the three-pollutant models (adjusting for NO 2 and O 3 simultaneously) the increase was 3.3% (95% CI, -0.2-6.9). There were no clear associations between the outcome and NO 2 , O 3 , or PM 10 during the colder season (October to March). Ambient air particle concentrations were associated with the number of visits to the Psychiatric emergency unit in the warm season. The results were only borderline statistically significant in the fully adjusted (three-pollutant) models in this small study. The observation could be interpreted as indicative of air pollution as either exacerbating an underlying psychiatric disorder, or increasing mental distress, even in areas with comparatively low levels of

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

    Directory of Open Access Journals (Sweden)

    Garfinkel D

    2011-08-01

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

  11. A randomised, controlled, crossover study of the effect of diet on angiopoietin-like protein 4 (ANGPTL4) through modification of the gut microbiome

    DEFF Research Database (Denmark)

    Blædel, Trine; Holm, Jacob B.; Sundekilde, Ulrik Kræmer

    2016-01-01

    -fat milk or as a result of fermentation of inulin. This study investigated whether a standardised diet either high in fat content or supplemented with inulin powder would increase plasma ANGPTL4 in overweight men and whether this increase was mediated through a compositional change of the gut microbiota....... The study had a crossover design with three arms, where participants were given a standardised isoenergetic diet supplemented with inulin powder, whole-fat milk or water (control). Plasma and urine samples were collected before and after each intervention period. Faecal samples and adipose tissue biopsies...... of bifidobacteria following the inulin diet was higher, compared with the control diet. However, the changes in microbiota were not associated with plasma ANGPTL4 and the overall composition of the microbiota did not change between the dietary periods. Although weight was maintained throughout the dietary periods...

  12. Switching to a 10-day Mediterranean-style diet improves mood and cardiovascular function in a controlled crossover study.

    Science.gov (United States)

    Lee, Jaime; Pase, Matthew; Pipingas, Andrew; Raubenheimer, Jessica; Thurgood, Madeline; Villalon, Lorena; Macpherson, Helen; Gibbs, Amy; Scholey, Andrew

    2015-05-01

    Even short-term adherence to a Mediterranean-style diet may benefit aspects of psychological functioning. The aim of the present study was to assess the effects of switching to a 10-d Mediterranean-style diet on mood, cognition, and cardiovascular measures. Using a crossover design, 24 women were randomly assigned to either the diet change (where they switched to a Mediterranean-style diet) or no diet change (normal diet) condition for 10 days before switching to the other condition for the same duration. Mood, cognition, and cardiovascular measures of blood pressure, blood flow velocity, and arterial stiffness were assessed at baseline and at the completion of the two diets (days 11 and 22). Independent of whether the Mediterranean-style diet was undertaken before or after the crossover, it was associated with significantly elevated contentment and alertness, and significantly reduced confusion. Additionally, aspects of cognition, such as memory recall, improved significantly as a result of switching to the Mediterranean-style diet. Regarding cardiovascular measures, there was a significant reduction in augmentation pressure associated with the Mediterranean-style diet intervention, but blood flow velocity through the common carotid artery did not change. This Mediterranean-style diet has the potential to enhance aspects of mood, cognition, and cardiovascular function in a young, healthy adult sample. Copyright © 2015 Elsevier Inc. All rights reserved.

  13. Thermal hysteresis kinetic effects of spin crossover nanoparticulated systems studied by FORC diagram method on an Ising-like model

    Science.gov (United States)

    Atitoaie, Alexandru; Stoleriu, Laurentiu; Tanasa, Radu; Stancu, Alexandru; Enachescu, Cristian

    2016-04-01

    The scientific community is manifesting a high research interest on spin crossover compounds and their recently synthesized nanoparticles, due to their various appealing properties, such as the bistability between a diamagnetic low spin state and a paramagnetic high spin state (HS), inter-switchable by temperature or pressure changes, light irradiation or magnetic field. The utility of these compounds showing hysteresis covers a broad area of applications, from the development of more efficient designs of temperature and pressure sensors to automotive and aeronautic industries and even a new type of molecular actuators. We are proposing in this work a study regarding the kinetic effects and the distribution of reversible and irreversible components on the thermal hysteresis of spin crossover nanoparticulated systems. We are considering here tridimensional systems with different sizes and also systems of nanoparticles with a Gaussian size distribution. The correlations between the kinetics of the thermal hysteresis, the distributions of sizes and intermolecular interactions and the transition temperature distributions were established by using the FORC (First Order Reversal Curves) method using a Monte Carlo technique within an Ising-like system.

  14. Acute effects of beer on endothelial function and hemodynamics: a single-blind, crossover study in healthy volunteers.

    Science.gov (United States)

    Karatzi, Kalliopi; Rontoyanni, Victoria G; Protogerou, Athanase D; Georgoulia, Aggeliki; Xenos, Konstantinos; Chrysou, John; Sfikakis, Petros P; Sidossis, Labros S

    2013-09-01

    Moderate consumption of beer is associated with lower cardiovascular (CV) risk. The goal of this study was to determine the effect of beer consumption on CV risk. To explore the underlying mechanisms, we studied the acute effects of the constituents of beer (alcohol and antioxidants), on established predictors of CV risk: endothelial function, aortic stiffness, pressure wave reflections and aortic pressure. In a randomized, single-blind, crossover study, 17 healthy, non-smoking, men (ages 28.5 ± 5.2 y with body mass index 24.4 ± 2.5 kg/m(2)) consumed on three separate occasions, at least 1 wk apart: 1. 400 mL of beer and 400 mL water, 2. 800 mL of dealcoholized beer (same amount of polyphenols as in the 400 mL of beer), and 3. 67 mL of vodka and 733 mL water (same amount of alcohol as in the 400 mL of beer). Each time aortic stiffness (pulse wave velocity), pressure wave reflections (AΙx), aortic and brachial pressure (Sphygmocor device), and endothelial function (brachial flow mediated dilatation) were assessed at fast and 1 and 2 h postprandial. Aortic stiffness was significantly and similarly reduced by all three interventions. However, endothelial function was significantly improved only after beer consumption (average 1.33%, 95% confidence interval [CI] 0.15-2.53). Although wave reflections were significantly reduced by all three interventions (average of beer: 9.1%, dealcoholized beer: 2.8%, vodka 8.5%, all CI within limits of significance), the reduction was higher after beer consumption compared with dealcoholized beer (P = 0.018). Pulse pressure amplification (i.e., brachial/aortic) was increased by all three test drinks. Beer acutely improves parameters of arterial function and structure, in healthy non-smokers. This benefit seems to be mediated by the additive or synergistic effects of alcohol and antioxidants and merits further investigation. Copyright © 2013 Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2016-01-01

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

  16. THE INFLUENCE OF CHRONIC TREATMENT WITH BETA-BLOCKADE AND ANGIOTENSIN-CONVERTING ENZYME-INHIBITION ON THE PERIPHERAL-BLOOD FLOW IN HYPERTENSIVE PATIENTS WITH AND WITHOUT CONCOMITANT INTERMITTENT CLAUDICATION - A COMPARATIVE CROSS-OVER TRIAL

    NARCIS (Netherlands)

    VANDEVEN, LLM; VANLEEUWEN, JTM; SMIT, AJ

    1994-01-01

    In a comparative cross-over trial we examined the influence of the betablocker bisoprolol and the ACE-inhibitor lisinopril on the peripheral blood flow of 2 groups of hypertensive patients with and without concomitant intermittent claudication. In 11 patients with hypertension without peripheral

  17. 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.

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

    Science.gov (United States)

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

    2016-12-01

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

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

    Science.gov (United States)

    Elrazek, E Abd

    2004-10-01

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

  20. Sotalol vs metoprolol for ventricular rate control in patients with chronic atrial fibrillation who have undergone digitalization: a single-blinded crossover study.

    Science.gov (United States)

    Kochiadakis, G E; Kanoupakis, E M; Kalebubas, M D; Igoumenidis, N E; Vardakis, K E; Mavrakis, H E; Vardas, P E

    2001-01-01

    To compare the effects of sotalol and metoprolol on heart rate, during isotonic (ITE) and isometric (IME) exercise and daily activities, in digitalized patients with chronic atrial fibrillation. The study had a randomized, single-blinded, crossover design. Twenty-three patients with chronic atrial fibrillation received placebo for 4 weeks, followed by a 4-week period of treatment with sotalol and metoprolol in random order. At the end of each period, the patients were assessed with 24-h ECG monitoring, a cardiopulmonary exercise test and a handgrip manoeuvre. Both agents produced a lower heart rate than placebo at rest and at all levels of isotonic exercise (P digitalized patients with atrial fibrillation. Sotalol is superior to metoprolol at submaximal exercise, resulting in better rate control during daily activities.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1999-03-01

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

  2. To compare PubMed Clinical Queries and UpToDate in teaching information mastery to clinical residents: a crossover randomized controlled trial.

    Science.gov (United States)

    Sayyah Ensan, Ladan; Faghankhani, Masoomeh; Javanbakht, Anna; Ahmadi, Seyed-Foad; Baradaran, Hamid Reza

    2011-01-01

    To compare PubMed Clinical Queries and UpToDate regarding the amount and speed of information retrieval and users' satisfaction. A cross-over randomized trial was conducted in February 2009 in Tehran University of Medical Sciences that included 44 year-one or two residents who participated in an information mastery workshop. A one-hour lecture on the principles of information mastery was organized followed by self learning slide shows before using each database. Subsequently, participants were randomly assigned to answer 2 clinical scenarios using either UpToDate or PubMed Clinical Queries then crossed to use the other database to answer 2 different clinical scenarios. The proportion of relevantly answered clinical scenarios, time to answer retrieval, and users' satisfaction were measured in each database. Based on intention-to-treat analysis, participants retrieved the answer of 67 (76%) questions using UpToDate and 38 (43%) questions using PubMed Clinical Queries (PUpToDate compared to 29 min (95% CI: 26 to 32) using PubMed Clinical Queries (PUpToDate and also overall satisfaction were higher among UpToDate users compared to PubMed Clinical Queries users (PUpToDate compared to Pubmed Clinical Queries can lead to not only a higher proportion of relevant answer retrieval within a shorter time, but also a higher users' satisfaction. So, addition of tutoring pre-appraised sources such as UpToDate to the information mastery curricula seems to be highly efficient.

  3. To compare PubMed Clinical Queries and UpToDate in teaching information mastery to clinical residents: a crossover randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Ladan Sayyah Ensan

    Full Text Available PURPOSE: To compare PubMed Clinical Queries and UpToDate regarding the amount and speed of information retrieval and users' satisfaction. METHOD: A cross-over randomized trial was conducted in February 2009 in Tehran University of Medical Sciences that included 44 year-one or two residents who participated in an information mastery workshop. A one-hour lecture on the principles of information mastery was organized followed by self learning slide shows before using each database. Subsequently, participants were randomly assigned to answer 2 clinical scenarios using either UpToDate or PubMed Clinical Queries then crossed to use the other database to answer 2 different clinical scenarios. The proportion of relevantly answered clinical scenarios, time to answer retrieval, and users' satisfaction were measured in each database. RESULTS: Based on intention-to-treat analysis, participants retrieved the answer of 67 (76% questions using UpToDate and 38 (43% questions using PubMed Clinical Queries (P<0.001. The median time to answer retrieval was 17 min (95% CI: 16 to 18 using UpToDate compared to 29 min (95% CI: 26 to 32 using PubMed Clinical Queries (P<0.001. The satisfaction with the accuracy of retrieved answers, interaction with UpToDate and also overall satisfaction were higher among UpToDate users compared to PubMed Clinical Queries users (P<0.001. CONCLUSIONS: For first time users, using UpToDate compared to Pubmed Clinical Queries can lead to not only a higher proportion of relevant answer retrieval within a shorter time, but also a higher users' satisfaction. So, addition of tutoring pre-appraised sources such as UpToDate to the information mastery curricula seems to be highly efficient.

  4. Influence of rapid malaria diagnostic tests on treatment and health outcome in fever patients, Zanzibar: a crossover validation study.

    Directory of Open Access Journals (Sweden)

    Mwinyi I Msellem

    2009-04-01

    Full Text Available The use of rapid diagnostic tests (RDTs for Plasmodium falciparum malaria is being suggested to improve diagnostic efficiency in peripheral health care settings in Africa. Such improved diagnostics are critical to minimize overuse and thereby delay development of resistance to artemisinin-based combination therapies (ACTs. Our objective was to study the influence of RDT-aided malaria diagnosis on drug prescriptions, health outcomes, and costs in primary health care settings.We conducted a cross-over validation clinical trial in four primary health care units in Zanzibar. Patients of all ages with reported fever in the previous 48 hours were eligible and allocated alternate weeks to RDT-aided malaria diagnosis or symptom-based clinical diagnosis (CD alone. Follow-up was 14 days. ACT was to be prescribed to patients diagnosed with malaria in both groups. Statistical analyses with multilevel modelling were performed. A total of 1,887 patients were enrolled February through August 2005. RDT was associated with lower prescription rates of antimalarial treatment than CD alone, 361/1005 (36% compared with 752/882 (85% (odds ratio [OR] 0.04, 95% confidence interval [CI] 0.03-0.05, p<0.001. Prescriptions of antibiotics were higher after RDT than CD alone, i.e., 372/1005 (37% and 235/882 (27% (OR 1.8, 95%CI 1.5-2.2, p<0.001, respectively. Reattendance due to perceived unsuccessful clinical cure was lower after RDT 25/1005 (2.5%, than CD alone 43/882 (4.9% (OR 0.5, 95% CI 0.3-0.9, p = 0.005. Total average cost per patient was similar: USD 2.47 and 2.37 after RDT and CD alone, respectively.RDTs resulted in improved adequate treatment and health outcomes without increased cost per patient. RDTs may represent a tool for improved management of patients with fever in peripheral health care settings.(Clinicaltrials.gov NCT00549003.

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

    Science.gov (United States)

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

    2017-03-16

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

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

    Directory of Open Access Journals (Sweden)

    Meena Shah

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

  7. Cerebellar transcranial direct current stimulation in children with ataxic cerebral palsy: A sham-controlled, crossover, pilot study.

    Science.gov (United States)

    Grecco, Luanda André Collange; Oliveira, Claudia Santos; Duarte, Natália de Almeida Carvalho; Lima, Vânia L C Carvalho; Zanon, Nelci; Fregni, Felipe

    2017-04-01

    The aim of the present study was to analyze the use of anodal tDCS of the cerebellar region combined with treadmill training to improve balance and functional performance in children with ataxic cerebral palsy. Single-blind, sham-controlled, crossover, pilot study. Rehabilitation center and research motion analysis laboratory. Children (N = 6) with ataxic cerebral palsy and balance deficit. Static balance (oscillations of the center of pressure), functional balance (Pediatric Balance Scale) and functional performance (Pediatric Evaluation of Disability Inventory) were evaluated. Significant reductions occurred in oscillations of the center of pressure with eyes closed after active anodal tDCS only. The effects of treadmill training on functional balance and functional performance in mobility were maintained in the active tDCS group only. These preliminary data support the notion that anodal tDCS of the cerebellar region combined with treadmill training improves balance in children with ataxic cerebral palsy.

  8. 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...

  9. An approach to checking case-crossover analyses based on equivalence with time-series methods.

    Science.gov (United States)

    Lu, Yun; Symons, James Morel; Geyh, Alison S; Zeger, Scott L

    2008-03-01

    The case-crossover design has been increasingly applied to epidemiologic investigations of acute adverse health effects associated with ambient air pollution. The correspondence of the design to that of matched case-control studies makes it inferentially appealing for epidemiologic studies. Case-crossover analyses generally use conditional logistic regression modeling. This technique is equivalent to time-series log-linear regression models when there is a common exposure across individuals, as in air pollution studies. Previous methods for obtaining unbiased estimates for case-crossover analyses have assumed that time-varying risk factors are constant within reference windows. In this paper, we rely on the connection between case-crossover and time-series methods to illustrate model-checking procedures from log-linear model diagnostics for time-stratified case-crossover analyses. Additionally, we compare the relative performance of the time-stratified case-crossover approach to time-series methods under 3 simulated scenarios representing different temporal patterns of daily mortality associated with air pollution in Chicago, Illinois, during 1995 and 1996. Whenever a model-be it time-series or case-crossover-fails to account appropriately for fluctuations in time that confound the exposure, the effect estimate will be biased. It is therefore important to perform model-checking in time-stratified case-crossover analyses rather than assume the estimator is unbiased.

  10. Oxygen therapy for cluster headache. A mask comparison trial. A single-blinded, placebo-controlled, crossover study

    DEFF Research Database (Denmark)

    Petersen, Anja S; Barloese, Mads Cj; Lund, Nunu Lt

    2017-01-01

    PURPOSE: The purpose of this article is to investigate possible differences in effect between three types of masks in the acute treatment of cluster headache (CH). PATIENTS AND METHODS: Fifty-seven CH patients according to ICHD-II-criteria participated in a single-blinded, semi-randomized, placeb...... DVO. Further, therapy by O2ptimask and DVO resulted in a decreased need for rescue medication. We recommend that CH patients be offered DVO or O2ptimask before oxygen therapy is abandoned.......-controlled, crossover inpatient study, and 102 CH attacks were treated with 100% oxygen delivered by demand valve oxygen (DVO), O2ptimask or simple mask (15 liters/min) or placebo delivered by DVO for 15 minutes. Primary endpoint: Two-point decrease of pain on a five-point rating scale within 15 minutes. RESULTS: Only...

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

    Science.gov (United States)

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

    2015-12-01

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

  12. How air pollution influences clinical management of respiratory diseases. A case-crossover study in Milan

    Directory of Open Access Journals (Sweden)

    Santus Pierachille

    2012-10-01

    Full Text Available Abstract Background Environmental pollution is a known risk factor for multiple diseases and furthermore increases rate of hospitalisations. We investigated the correlation between emergency room admissions (ERAs of the general population for respiratory diseases and the environmental pollutant levels in Milan, a metropolis in northern Italy. Methods We collected data from 45770 ERAs for respiratory diseases. A time-stratified case-crossover design was used to investigate the association between air pollution levels and ERAs for acute respiratory conditions. The effects of air pollutants were investigated at lag 0 to lag 5, lag 0–2 and lag 3–5 in both single and multi-pollutant models, adjusted for daily weather variables. Results An increase in ozone (O3 levels at lag 3–5 was associated with a 78% increase in the number of ERAs for asthma, especially during the warm season. Exposure to carbon monoxide (CO proved to be a risk factor for pneumonia at lag 0–2 and in the warm season increased the risk of ERA by 66%. A significant association was found between ERAs for COPD exacerbation and levels of sulphur dioxide (SO2, CO, nitrate dioxide (NO2, and particulate matter (PM10 and PM2.5. The multipollutant model that includes all pollutants showed a significant association between CO (26% and ERA for upper respiratory tract diseases at lag 0–2. For chronic obstructive pulmonary disease (COPD exacerbations, only CO (OR 1.19 showed a significant association. Conclusions Exposure to environmental pollution, even at typical low levels, can increase the risk of ERA for acute respiratory diseases and exacerbation of obstructive lung diseases in the general population.

  13. How air pollution influences clinical management of respiratory diseases. A case-crossover study in Milan.

    Science.gov (United States)

    Santus, Pierachille; Russo, Antonio; Madonini, Enzo; Allegra, Luigi; Blasi, Francesco; Centanni, Stefano; Miadonna, Antonio; Schiraldi, Gianfranco; Amaducci, Sandro

    2012-10-18

    Environmental pollution is a known risk factor for multiple diseases and furthermore increases rate of hospitalisations. We investigated the correlation between emergency room admissions (ERAs) of the general population for respiratory diseases and the environmental pollutant levels in Milan, a metropolis in northern Italy. We collected data from 45770 ERAs for respiratory diseases. A time-stratified case-crossover design was used to investigate the association between air pollution levels and ERAs for acute respiratory conditions. The effects of air pollutants were investigated at lag 0 to lag 5, lag 0-2 and lag 3-5 in both single and multi-pollutant models, adjusted for daily weather variables. An increase in ozone (O(3)) levels at lag 3-5 was associated with a 78% increase in the number of ERAs for asthma, especially during the warm season. Exposure to carbon monoxide (CO) proved to be a risk factor for pneumonia at lag 0-2 and in the warm season increased the risk of ERA by 66%. A significant association was found between ERAs for COPD exacerbation and levels of sulphur dioxide (SO(2)), CO, nitrate dioxide (NO(2)), and particulate matter (PM(10) and PM(2.5)). The multipollutant model that includes all pollutants showed a significant association between CO (26%) and ERA for upper respiratory tract diseases at lag 0-2. For chronic obstructive pulmonary disease (COPD) exacerbations, only CO (OR 1.19) showed a significant association. Exposure to environmental pollution, even at typical low levels, can increase the risk of ERA for acute respiratory diseases and exacerbation of obstructive lung diseases in the general population.

  14. Acute blood pressure response in hypertensive elderly women immediately after water aerobics exercise: A crossover study.

    Science.gov (United States)

    Cunha, Raphael Martins; Vilaça-Alves, José; Noleto, Marcelo Vasconcelos; Silva, Juliana Sá; Costa, Andressa Moura; Silva, Christoffer Novais Farias; Póvoa, Thaís Inácio Rolim; Lehnen, Alexandre Machado

    2017-01-01

    Water aerobics exercise is widely recommended for elderly people. However, little is known about the acute effects on hemodynamic variables. Thus, we assessed the effects of a water aerobic session on blood pressure in hypertensive elderly women. Fifty hypertensive elderly women aged 67.8 ± 4.1 years, 1.5 ± 0.6 m high and BMI 28.6 ± 3.9 kg/m(2), participated in a crossover clinical trial. The experiment consisted of a 45-minute water aerobics session (70%-75% HRmax adjusted for the aquatic environment) (ES) and a control session (no exercise for 45 minutes) (CS). Heart rate was monitored using a heart rate monitor and systolic blood pressure (SBP) and diastolic (DBP) measurements were taken using a semi-automatic monitor before and immediately after the sessions, and at 10, 20 and 30 minutes thereafter. It was using a generalized estimating equation (GEE) with Bonferroni's post-hoc test (p exercise, BP declined in ES by a greater magnitude than in CS (SBP 7.5 mmHg, 6.2%, p = 0.005 and DBP 3.8 mmHg, 5.5%, p = 0.013). At 20 minutes after exercise and thereafter, SBP and DBP were similar in both ES and CS. In conclusion, BP returned to control levels within 10-20 minutes remaining unchanged until 30 minutes after exercise, and post-exercise hypotension was not observed. Besides, BP changed after exercise was a safe rise of small magnitude for hypertensive people.

  15. Interchangeability of gabapentin generic formulations in the Netherlands: a comparative bioavailability study

    NARCIS (Netherlands)

    Yu, Y.; Teerenstra, S.; Vanmolkot, F.; Neef, C.; Burger, D.M.; Maliepaard, M.

    2013-01-01

    To investigate the so-called "drift" with generic-generic drug substitution, a single-dose, four-way crossover comparative bioavailability study was performed involving 24 healthy subjects and three generic and one branded formulation of a tablet containing 800 mg gabapentin as test medication. The

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

    Science.gov (United States)

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

    2017-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Tanja Freis

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

  18. Urban air pollution and emergency room admissions for respiratory symptoms: a case-crossover study in Palermo, Italy

    Directory of Open Access Journals (Sweden)

    Calamusa Giuseppe

    2011-04-01

    Full Text Available Abstract Background Air pollution from vehicular traffic has been associated with respiratory diseases. In Palermo, the largest metropolitan area in Sicily, urban air pollution is mainly addressed to traffic-related pollution because of lack of industrial settlements, and the presence of a temperate climate that contribute to the limited use of domestic heating plants. This study aimed to investigate the association between traffic-related air pollution and emergency room admissions for acute respiratory symptoms. Methods From January 2004 through December 2007, air pollutant concentrations and emergency room visits were collected for a case-crossover study conducted in Palermo, Sicily. Risk estimates of short-term exposures to particulate matter and gaseous ambient pollutants including carbon monoxide, nitrogen dioxide, and sulfur dioxide were calculated by using a conditional logistic regression analysis. Results Emergency departments provided data on 48,519 visits for respiratory symptoms. Adjusted case-crossover analyses revealed stronger effects in the warm season for the most part of the pollutants considered, with a positive association for PM10 (odds ratio = 1.039, 95% confidence interval: 1.020 - 1.059, SO2 (OR = 1.068, 95% CI: 1.014 - 1.126, nitrogen dioxide (NO2: OR = 1.043, 95% CI: 1.021 - 1.065, and CO (OR = 1.128, 95% CI: 1.074 - 1.184, especially among females (according to an increase of 10 μg/m3 in PM10, NO2, SO2, and 1 mg/m3 in CO exposure. A positive association was observed either in warm or in cold season only for PM10. Conclusions Our findings suggest that, in our setting, exposure to ambient levels of air pollution is an important determinant of emergency room (ER visits for acute respiratory symptoms, particularly during the warm season. ER admittance may be considered a good proxy to evaluate the adverse effects of air pollution on respiratory health.

  19. Assessment of the abuse liability of a dual orexin receptor antagonist: a crossover study of almorexant and zolpidem in recreational drug users.

    Science.gov (United States)

    Cruz, Hans G; Hoever, Petra; Chakraborty, Bijan; Schoedel, Kerri; Sellers, Edward M; Dingemanse, Jasper

    2014-04-01

    Dual orexin receptor antagonists (DORAs) enable initiation and maintenance of sleep in patients with primary insomnia. Blockade of the orexin system has shown reduction of drug-seeking behavior in animal studies, supporting the role of orexin antagonism as a novel approach for treating substance abuse. Since hypnotics are traditionally associated with misuse, a lack of abuse liability of DORAs would offer significant benefits over current therapies for sleep disorders. In this randomized, crossover, proof-of-concept study, single oral doses of the DORA almorexant (200, 400, and 1,000 mg) were administered to healthy subjects with previous non-therapeutic experience with central nervous system depressants and were compared with placebo and single oral doses of zolpidem (20 and 40 mg), a benzodiazepine-like drug. Subjective measures of abuse potential (visual analog scales [VAS], Addiction Research Center Inventory, and Subjective Drug Value) and objective measures (divided attention [DA]) were evaluated over 24 h post-dose in 33 evaluable subjects. Drug Liking VAS peak effect (E max; primary endpoint) was significantly higher for all doses of almorexant and zolpidem compared with placebo (pDrug Liking' than both zolpidem doses (peffects than zolpidem 20 mg (peffects compared with zolpidem. Almorexant also showed less cognitive impairment compared with zolpidem on most DA endpoints. This study in humans investigating single doses of almorexant is the first to explore and show abuse liability of a DORA, a class of compounds that is not only promising for the treatment of sleep disorders, but also of addiction.

  20. A randomised, controlled, crossover study to investigate the pharmacodynamics, pharmacokinetics and safety of 1R,2S-methoxamine hydrochloride (NRL001) in healthy elderly subjects.

    Science.gov (United States)

    Bell, D; Duffin, A; Gruss, H J; Pediconi, C; Jacobs, A

    2014-03-01

    This study aimed to assess the effects of a single dose of 10 mg NRL001 (the 1R,2S stereoisomer of methoxamine hydrochloride) in a 2 g suppository on pharmacodynamic and pharmacokinetic (PK) variables, and safety, in a healthy elderly population. This was a Phase I, single-centre, randomised, double-blind, placebo-controlled crossover study during which subjects received a single 2 g suppository of 10 mg NRL001 and a matching placebo in two separate treatment periods. The main outcome measures were Holter-, vital signs- and electrocardiogram-derived cardiovascular variables; plasma PK analysis; and safety assessments. Twenty-six subjects were dosed with study medication. Statistically significant reductions in Holter-derived heart rate (HR), vital signs-derived HR and diastolic blood pressure (BP) were observed comparing NRL001 with placebo treatment, and also with increasing NRL001 plasma concentration. No statistically significant relationships were observed between NRL001 concentration and systolic BP, mean arterial pressure or QTC interval (both Bazett's and Fridericia's correction). Thirty-nine adverse events were reported in 20 (76.9%) subjects, mostly after dosing with NRL001. Administration of NRL001 suppositories led to decreases in HR when compared with placebo data. NRL001 was well tolerated with a good safety profile during the study. Healthy elderly subjects did not show significantly different biological responses to NRL001 suppositories compared with younger healthy volunteers in previous studies. Colorectal Disease © 2014 The Association of Coloproctology of Great Britain and Ireland.

  1. Risk of injury after alcohol consumption from case-crossover studies in five countries from the America’s

    Science.gov (United States)

    Borges, Guilherme; Orozco, Ricardo; Monteiro, Maristela; Cherpitel, Cheryl; Then, Eddy Pérez; López, Víctor A.; Bassier-Paltoo, Marcia; Weil A., Donald; de Bradshaw, Aldacira M

    2012-01-01

    Aims This study aimed to: 1) provide relative risk (RR) estimates between acute alcohol use and injuries from emergency departments in the Dominican Republic, Guatemala, Guyana, Nicaragua and Panama, and 2) test whether the RR differs if two control periods for the estimates were used. Design Case-crossover methodology was used to obtain estimates of the RR of having an injury within six hours after drinking alcohol, using a pair-matching design with control periods of the same time of day the day prior to injury, and the same time of day and day of week the week prior to injury. Setting Emergency departments(EDs). Participants 2,503 injured patients from EDs were interviewed between 2010–2011, with a response rate of 92.6%. Measurements Number of drinks consumed within six hours prior to the injury and in the two control periods. Findings The RR of injury after drinking alcohol was 4.38 (95% confidence interval CI= 3.29–5.84) using as the control period the prior week, and 5.35 (CI=3.50–8.17) using as a control period the prior day. The RR was 5.08 (CI=4.15–6.23) in multiple matching. Those drinking 1–2 drinks had a RR of 4.85 (CI=3.12–7.54); those drinking 3–5 a RR of 5.00 (CI =3.47–7.18); those drinking 6–15 a RR of 4.54 (CI=3.36–6.14); and those drinking 16 or more a RR of 10.42 (CI=4.38–24.79). Conclusions As in other countries, alcohol drinking is a trigger for an injury in all five countries. The use of more than one control period give further strength to these findings from case-crossover analysis. PMID:22775508

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

    Science.gov (United States)

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

    2017-02-01

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

  3. Virtually optimized insoles for offloading the diabetic foot: A randomized crossover study.

    Science.gov (United States)

    Telfer, S; Woodburn, J; Collier, A; Cavanagh, P R

    2017-07-26

    Integration of objective biomechanical measures of foot function into the design process for insoles has been shown to provide enhanced plantar tissue protection for individuals at-risk of plantar ulceration. The use of virtual simulations utilizing numerical modeling techniques offers a potential approach to further optimize these devices. In a patient population at-risk of foot ulceration, we aimed to compare the pressure offloading performance of insoles that were optimized via numerical simulation techniques against shape-based devices. Twenty participants with diabetes and at-risk feet were enrolled in this study. Three pairs of personalized insoles: one based on shape data and subsequently manufactured via direct milling; and two were based on a design derived from shape, pressure, and ultrasound data which underwent a finite element analysis-based virtual optimization procedure. For the latter set of insole designs, one pair was manufactured via direct milling, and a second pair was manufactured through 3D printing. The offloading performance of the insoles was analyzed for forefoot regions identified as having elevated plantar pressures. In 88% of the regions of interest, the use of virtually optimized insoles resulted in lower peak plantar pressures compared to the shape-based devices. Overall, the virtually optimized insoles significantly reduced peak pressures by a mean of 41.3kPa (p<0.001, 95% CI [31.1, 51.5]) for milled and 40.5kPa (p<0.001, 95% CI [26.4, 54.5]) for printed devices compared to shape-based insoles. The integration of virtual optimization into the insole design process resulted in improved offloading performance compared to standard, shape-based devices. ISRCTN19805071, www.ISRCTN.org. Copyright © 2017 Elsevier Ltd. All rights reserved.

  4. An Intercomparison of Dissolved Iron Speciation at the Bermuda Atlantic Time-series Study (BATS) Site: Results from GEOTRACES Crossover Station A

    NARCIS (Netherlands)

    Buck, K.N.; Gerringa, L.J.A.; Rijkenberg, M.J.A.

    2016-01-01

    The organic complexation of dissolved iron (Fe) was determined in depth profile samples collected from GEOTRACES Crossover Station A, the Bermuda Atlantic Time-series Study (BATS) site, as part of the Dutch and U.S. GEOTRACES North Atlantic programs in June 2010 and November 2011, respectively. The

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

    National Research Council Canada - National Science Library

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

    2014-01-01

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

  6. Comparison of the effects of ranitidine effervescent tablets and magnesium hydroxide-aluminium oxide on intragastric acidity. A single-centre, randomised, open cross-over study.

    Science.gov (United States)

    Propst, A; Propst, T; Judmaier, G

    1996-06-01

    In previous studies measuring intragastric pH in healthy volunteers it was shown that there was a faster onset of action with ranitidine (CAS 66357-35-5) 300 mg effervescent tablets (Zantac) compared to standard tablets. In a single-centre, randomised, open cross-over study the pH-values obtained over 6 h following the administration of one ranitidine 150 mg effervescent tablet were compared with those after aluminium oxide-magnesium hydroxide (algeldrate, CAS 1330-44-5, Al-Mg-hydroxide) 10 ml and placebo in healthy volunteers. 24 healthy male subjects between 19 and 32 years of age entered the study, 19 subjects were available for all three measurements. After an overnight fast, intragastric pH was monitored for 7 h using a glass electrode and a digital data recorder. The time in % during which the pH was > or = 3.5 and the area under the curve of the obtained pH-curves were compared. There was a highly statistically significant difference between ranitidine effervescent tablets versus Al-Mg-hydroxide and placebo whereas there was no such difference between Al-Mg-hydroxide and placebo. The onset of action of ranitidine effervescent tablets was almost immediate. It is concluded that there was a clear superiority of ranitidine effervescent tablets in healthy volunteers and it is suggested that pH-metry in patients with acidity-related diseases should be investigated for a better understanding of the function of effervescent tablets.

  7. Bacterial contamination of surgical scrub suits worn outside the operating theatre: a randomised crossover study.

    Science.gov (United States)

    Hee, H I; Lee, S; Chia, S N; Lu, Q S; Liew, A P Q; Ng, A

    2014-08-01

    In this study, we aimed to evaluate the bacterial contamination of surgical scrub suits worn outside the operating theatre. We randomised 16 anaesthetists on separate occasions into one of 3 groups: restricted to the operating theatre only; theatre and surgical wards; and theatre and departmental office. For each group, sample fabric pieces attached to the chest, waist and hip areas of each suit were removed at 150 min intervals between 08:30 and 16:00 on the day of study, and sent for microbiological assessment. Mean bacterial counts increased significantly over the course of the working day (p = 0.036), and were lower in the chest compared to the hip (p = 0.007) and waist areas (p = 0.016). The mean (SD) bacterial counts, expressed as colony-forming units per cm(2) at 16:00 on the day of study, were 25.2 (43.5) for those restricted to theatre and 18.5 (25.9) and 17.9 (31.0) for those allowed out to visit the ward and office, respectively (p = 0.370). We conclude that visits to ward and office did not significantly increase bacterial contamination of scrub suits. © 2014 The Association of Anaesthetists of Great Britain and Ireland.

  8. Take a walk in the park? A cross-over pilot trial comparing brisk walking in two different environments: park and urban.

    Science.gov (United States)

    Sellers, C E; Grant, P M; Ryan, C G; O'Kane, C; Raw, K; Conn, D

    2012-11-01

    The objective of the present study is to investigate whether differences exist between a 30 minute brisk walk taken in two different environments in order to determine which environment best facilitates current physical activity guidelines: park or urban. In this randomised cross-over pilot study, participants performed a self-timed 30 minute brisk walk in two different environments, park and urban, in Glasgow, Scotland (October 2009 to January 2010). Cadence, recorded using the activPAL™ activity monitor, was used to measure intensity. Outcome measures were: mean cadence; moderate-to-vigorous physical activity time accumulated in bouts lasting ≥ 10 min; number of walking breaks; and duration. A convenience sample of 40 healthy adults was recruited: 16 males, 24 females, mean age 22.9 (5.5) years. The mean cadence for the whole walk was higher in the park: 119.3 (8.3) vs. 110.9 (8.9) steps/min. Participants accumulated more moderate-to-vigorous physical activity in ≥ 10 minute bouts during park walks: 25.5 (9.6) [median (interquartile range)] vs. 14.0 (20.3) min. There was no difference in self-timed duration between locations. Participants accumulated more moderate-to-vigorous physical activity in bouts ≥ 10 min in duration on park walks due to the lack of interruptions in walking. Hence the park environment better facilitated the achievement of current physical activity guidelines. Further research involving a larger, more heterogeneous sample is recommended. Copyright © 2012 Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2015-05-01

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

  10. Acupuncture as an adjunct therapy in the treatment of eating disorders: a randomised cross-over pilot study.

    Science.gov (United States)

    Fogarty, Sarah; Harris, David; Zaslawski, Chris; McAinch, Andrew J; Stojanovska, Lily

    2010-12-01

    This study examines the role of acupuncture as an adjunct therapy in the treatment of eating disorders in female patients. A randomised cross-over study was used in this study. The two treatments phases were the private multi-disciplinary outpatient eating disorder facility in Melbourne, Australia, only (referred to as their treatment as usual) and a continuation of their treatment as usual supplemented by acupuncture. Patients receiving treatment at a private multi-disciplinary outpatient eating disorder facility in Melbourne, Australia were asked to participate in the study. Nine consenting women (5 with Anorexia Nervosa, 4 with Bulimia Nervosa), aged (mean and SD) 23.7 (9.6) years, participated in the study. The main outcome measure was the Eating Disorder Inventory-3. Secondary outcome measures were the Becks Depression Inventory-2, State Trait Anxiety Inventory and the Eating Disorder Quality of Life Scale. There was evidence that acupuncture improved the participants' Quality of Life as measured by the physical/cognitive and psychological components of the Eating Disorder Quality of Life scale. There was also evidence of decreases in anxiety (both State and Trait as measured by the State Trait Anxiety Intervention) and perfectionism (as measured by the Eating Disorder Inventory-3). This pilot study shows potential of the benefit of acupuncture as an adjunct therapy in the treatment of eating disorders particularly in the area of quality of life. Crown Copyright © 2010. Published by Elsevier Ltd. All rights reserved.

  11. Relationship between toothpastes properties and patient-reported discomfort: crossover study.

    Science.gov (United States)

    Bruno, Mariana; Taddeo, Fernando; Medeiros, Igor Studart; Boaro, Letícia Cristina Cidreira; Moreira, Maria Stella N A; Marques, Márcia Martins; Calheiros, Fernanda Calabró

    2016-04-01

    This study aims to correlate patient-reported reactions with in vitro analyses of the pH, abrasive quality, and cytotoxicity of four toothpastes. One hundred twenty-one patients received non-identified samples of toothpaste to be used for 6 days and answered a questionnaire about their sensations. In vitro analysis: the pH of toothpastes was measured with a pH meter. The abrasivity of toothpastes was evaluated against composite resin specimens (n = 10). A toothbrushing machine was used to simulate wear, which was indirectly measured by mass loss using a scale. Cell culture media conditioned with toothpaste were used to assess the cytotoxicity. Confluent cells were kept in contact with the conditioned media or control for 24 h. The cell viability was measured using the 3-(bromide, 4,5-dimethylthiazol-2yl)-2,5-diphenyltetrazolium (MTT)-reduction assay. The obtained data on the pH, weight loss, and cell viability were compared by ANOVA/Tukey's tests (p peeling, dry mouth, thrush, tingling, and taste changes in response to this paste. The in vitro analysis demonstrated that Oral B® had the lowest pH, the highest abrasivity, and produced the lowest cell viability (p abrasive and cytotoxic may cause undesirable reactions in patients. Toothpaste's properties should be well known for indication to patient therefore minimizing discomfort reports.

  12. Comparison of clinical and dental panoramic findings: a practice-based crossover study.

    Science.gov (United States)

    Moll, Marc A; Seuthe, Miriam; von See, Constantin; Zapf, Antonia; Hornecker, Else; Mausberg, Rainer F; Ziebolz, Dirk

    2013-09-26

    Aim was to compare clinical findings with x-ray findings using dental panoramic radiography (DPR). In addition, type and frequency of secondary findings in x-rays were investigated. Patients were selected on the basis of available DPRs (not older than 12 months). No therapeutic measures were permitted between the DPR and the clinical findings. The clinical findings were carried out by several investigators who had no knowledge of the purpose of the study. A calibrated investigator established the x-ray findings, independently and without prior knowledge of the clinical findings. The evaluation parameters for each tooth were: missing, healthy, carious, restorative or prosthetically sufficient or insufficient treatment. Type and frequency of additional findings in the DPR were documented, e.g. quality of a root canal filling and apical changes. Findings of 275 patients were available. Comparison showed a correspondence between clinical and radiographic finding in 93.6% of all teeth (n = 7,789). The differences were not significant (p > 0.05). Regarding carious as well as insufficiently restored or prosthetically treated teeth, respectively there were significant differences between the two methods (p x-ray findings were found.

  13. Effects of whole-grain rye porridge with added inulin and wheat gluten on appetite, gut fermentation and postprandial glucose metabolism: a randomised, cross-over, breakfast study.

    Science.gov (United States)

    Lee, Isabella; Shi, Lin; Webb, Dominic-Luc; Hellström, Per M; Risérus, Ulf; Landberg, Rikard

    2016-12-01

    Whole-grain rye foods reduce appetite, insulin and sometimes glucose responses. Increased gut fermentation and plant protein may mediate the effect. The aims of the present study were to investigate whether the appetite-suppressing effects of whole-grain rye porridge could be enhanced by replacing part of the rye with fermented dietary fibre and plant protein, and to explore the role of gut fermentation on appetite and metabolic responses over 8 h. We conducted a randomised, cross-over study using two rye porridges (40 and 55 g), three 40-g rye porridges with addition of inulin:gluten (9:3; 6:6; 3:9 g) and a refined wheat bread control (55 g), served as part of complete breakfasts. A standardised lunch and an ad libitum dinner were served 4 and 8 h later, respectively. Appetite, breath hydrogen and methane, glucose, insulin and glucagon-like peptide-1 (GLP-1) responses were measured over 8 h. Twenty-one healthy men and women, aged 23-60 years, with BMI of 21-33 kg/m2 participated in this study. Before lunch, the 55-g rye porridges lowered hunger by 20 % and desire to eat by 22 % and increased fullness by 29 % compared with wheat bread (Pinulin and gluten compared with plain rye porridges.

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

    Science.gov (United States)

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

    2014-09-23

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

  15. Gaseous Air Pollution and the Risk for Stroke Admissions: A Case-Crossover Study in Beijing, China.

    Science.gov (United States)

    Huang, Fangfang; Luo, Yanxia; Tan, Peng; Xu, Qin; Tao, Lixin; Guo, Jin; Zhang, Feng; Xie, Xueqin; Guo, Xiuhua

    2017-02-14

    Background: Though increasing evidence supports association between gaseous air pollution and stroke, it remains unclear whether the effects differ in season, sex and age. The aim of this study was to examine the associations of gaseous air pollution with stroke admissions in Beijing, 2013-2014 in different subgroups. Methods: Case-crossover design and conditional logistic regression were used to perform the analyses. We examined the exposure-response relationship between air pollution and stroke. Stratified analyses were performed in different seasons, sex, and age groups. Results: There were 147,624 stroke admissions during the study period. In the whole study period, percent changes of stroke admissions were 0.82% (95% CI: 0.52% to 1.13%) and 0.73% (95% CI: 0.44% to 1.03%) per 10 μg/m³ increase in the same day conentration of nitrogen dioxide (NO₂) and sulfur dioxide (SO₂). The positive associations were higher in warm seasons and with patients >65 years (p 65 years. The associations of CO and ozone with stroke admissions differed across seasons.

  16. Kinesio Taping Does Not Alter Quadriceps Isokinetic Strength and Power in Healthy Nonathletic Men: A Prospective Crossover Study

    Directory of Open Access Journals (Sweden)

    Paweł Korman

    2015-01-01

    Full Text Available Objectives. The effects of Kinesio Taping (KT on muscular performance remain largely unclear. This study aimed to investigate the acute effects of KT on the maximum concentric and eccentric quadriceps isokinetic strength. Study Design. This is a single-blinded, placebo crossover, repeated measures study. Methods. Maximum isokinetic concentric/eccentric extension torque, work, and power were assessed by an isokinetic dynamometer without taping (NT and with KT or placebo taping (PT in 17 healthy young men. Repeated measures one-way analysis of variance (ANOVA was used for statistical analyses. Results. Testing concentric contractions at 60°/s or 180°/s isokinetic speed, no significant differences in peak torque (Nm, total work (J, or mean power (W were noted among the application modes under different conditions. Testing eccentric contractions at 30°/s or 60°/s isokinetic speed, no significant differences in mentioned parameters were noted, respectively. KT on the quadriceps neither decreased nor increased muscle strength in the participants. Conclusion. KT application onto the skin overlying the quadriceps muscle does not enhance the strength or power of knee extensors in healthy men.

  17. Effect of hypotonic 0.4% hyaluronic acid drops in dry eye patients: a cross-over study.

    Science.gov (United States)

    Troiano, Pasquale; Monaco, Gaspare

    2008-12-01

    The aim of the study is to evaluate the short-term effects of 2 kinds of artificial tears, both containing 0.4% hyaluronic acid in an aqueous solution yet having different osmolarity, on the typical symptoms of patients suffering from dry eye and on the vitality of corneal and conjunctival epithelial cells. A cross-over, randomized, balanced, single-blind study involving 28 patients was divided into 2 treatment groups: group A (unpreserved 0.4% hyaluronic acid eye drops 300 mOsm/L) and group B (unpreserved 0.4% hyaluronic acid eye drops 150 mOsm/L). Both treatments were administered for 7 days, being dosed as a 1 solution drop 4 times daily. After a 1-day wash-out period, the patients in group A passed over to group B and vice versa. Treatment with hypotonic solution gave better results in relieving symptoms, along with a statistically significant improvement (P < 0.001) in the state of the corneoconjunctival epithelium, than the isotonic solution. At the end of the study, 60.7% of the patients declared that they preferred hypotonic solution and only 10.7% preferred isotonic solution; the remaining 28.6% did not notice any difference between the 2 treatments. By reducing the osmolarity of tear film, the hypotonic solution not only improves the characteristics of tear film and the vitality of the epithelial cells of the cornea and conjunctiva but also proves to be effective in reducing dry eye symptoms.

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

    Directory of Open Access Journals (Sweden)

    Asli Akyol

    2014-09-01

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

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

    Directory of Open Access Journals (Sweden)

    Hiroshi M. Ueno

    2016-05-01

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

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

    Science.gov (United States)

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

    2016-05-31

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

  1. Acute effect of red meat and dairy on glucose and insulin: a randomized crossover study.

    Science.gov (United States)

    Turner, Kirsty M; Keogh, Jennifer B; Clifton, Peter M

    2016-01-01

    In contrast with some epidemiologic evidence, our previous research showed that a 4-wk diet that was high in low-fat dairy reduced insulin sensitivity compared with the effect of a diet that was high in red meat. We investigated whether a dairy meal would produce a greater insulin response than a carbohydrate-matched red meat meal would, which might account for the change in insulin sensitivity. One meal contained lean red meat, bread, and orange juice, and the other meal contained skim milk, low-fat yogurt, cheese, and bread. Meals were isoenergetic, equal in macronutrient profile, and consumed 1 wk apart. Glucose, insulin, and triglycerides were measured before and 30, 60, 90, 120, 150, and 180 min after meal consumption. Differences between meals were tested with the use of a repeated-measures ANOVA and paired sample t tests. Nineteen men and 24 women [mean ± SD age: 50.8 ± 16.0 y; body mass index (in kg/m(2)): 30.0 ± 3.5] completed the study. Twenty-two participants had normal glucose tolerance, and 21 participants had impaired fasting glucose or impaired glucose tolerance. The red meat meal resulted in a higher glucose response at 30 min after consumption (P glycemic response. The higher glucose response 30 min after consumption of the red meat meal was likely attributable to differences in the glycemic load between orange juice and milk and yogurt. An insulinotropic effect of dairy was not observed. This trial was registered at www.anzctr.org.au as ACTRN12615000164594. © 2016 American Society for Nutrition.

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

    Science.gov (United States)

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

    2016-10-01

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

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

    Directory of Open Access Journals (Sweden)

    Singh Betsy B

    2009-06-01

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

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

    Science.gov (United States)

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

    2013-10-01

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

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

    Science.gov (United States)

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

    2016-10-01

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

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

    Science.gov (United States)

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

    2017-10-23

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

  7. Magnetic Susceptibility Study of Sub-Pico-emu Sample Using a Micromagnetometer: An Investigation through Bistable Spin-Crossover Materials.

    Science.gov (United States)

    Kamara, Souleymane; Tran, Quang-Hung; Davesne, Vincent; Félix, Gautier; Salmon, Lionel; Kim, Kunwoo; Kim, CheolGi; Bousseksou, Azzedine; Terki, Ferial

    2017-12-01

    A promising and original method to study the spin-transition in bistable spin-crossover (SCO) materials using a magnetoresistive multiring sensor and its self-generated magnetic field is reported. Qualitative and quantitative studies are carried out combining theoretical and experimental approaches. The results show that only a small part of matter dropped on the sensor surface is probed by the device. At a low bias-current range, the number of detected nanoparticles depends on the amplitude of the current. However, in agreement with the theoretical model, the stray voltage from the particles is proportional to the current squared. By changing both the bias current and the concentration of particle droplet, the thermal hysteresis of an ultrasmall volume, 1 × 10-4 mm3 , of SCO particles is measured. The local probe of the experimental setup allows a highest resolution of 4 × 10-14 emu to be reached, which is never achieved by experimental methods at room temperature. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

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

    Science.gov (United States)

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

    2007-12-01

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

  9. Improvement in critical thinking dispositions of undergraduate nursing students through problem-based learning: a crossover-experimental study.

    Science.gov (United States)

    Yu, Dehong; Zhang, Yaqing; Xu, Yun; Wu, Juemin; Wang, Caifeng

    2013-10-01

    Critical thinking (CT) is important to nursing education and practice. Although there is evidence that active learning approaches, such as problem-based learning (PBL), are effective in developing CT dispositions, the findings are inconclusive. This study examines the effect of PBL on the development of CT dispositions in nursing students using a crossover-experimental study in a course offered to nursing students in China. All students were randomly assigned to two parallel groups, with one group receiving PBL and the other receiving lecture-based learning (LBL) as a control. The CT Dispositions Inventory-Chinese Version was administered before and after the semester-long course. Data were collected at three time points. No significant differences between groups were noted in overall and sub-scale scores at baseline; however, pronounced differences in overall posttest scores existed between the PBL and LBL groups. Thus, PBL learning significantly enhanced the CT dispositions of nursing students enrolled in Medical-Surgical Nursing II. Copyright 2013, SLACK Incorporated.

  10. Ambient Heat and Sudden Infant Death: A Case-Crossover Study Spanning 30 Years in Montreal, Canada.

    Science.gov (United States)

    Auger, Nathalie; Fraser, William D; Smargiassi, Audrey; Kosatsky, Tom

    2015-07-01

    Climate change may lead to more severe and extreme heat waves in the future, but its potential impact on sudden infant death-a leading cause of infant mortality-is unclear. We sought to determine whether risk of sudden infant death syndrome (SIDS) is elevated during hot weather. We undertook a case-crossover analysis of all sudden infant deaths during warm periods in metropolitan Montreal, Quebec, Canada, from 1981 through 2010. Our analysis included a total of 196 certified cases of SIDS, including 89 deaths at 1-2 months of age, and 94 at 3-12 months. We estimated associations between maximum outdoor temperatures and SIDS by comparing outdoor temperatures on the day of or day before a SIDS event with temperatures on control days during the same month, using cubic splines to model temperature and adjusting for relative humidity. Maximum daily temperatures of ≥ 29°C on the same day were associated with 2.78 times greater odds of sudden infant death relative to 20°C (95% CI: 1.64, 4.70). The likelihood of sudden death increased steadily with higher temperature. Associations were stronger for infants 3-12 months of age than for infants 1-2 months of age, with odds ratios of 3.90 (95% CI: 1.87, 8.13) and 1.73 (95% CI: 0.80, 3.73), respectively, for 29°C compared with 20°C on the day of the event. High ambient temperature may be a novel risk factor for SIDS, especially at ≥ 3 months of age. Climate change and the higher temperatures that result may account for a potentially greater proportion of sudden infant deaths in the future.

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

    Science.gov (United States)

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

    2014-08-01

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

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

    OpenAIRE

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

    2013-01-01

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

  13. Truncated AUC in the evaluation of fluconazole bioequivalence. A cross-over, randomised, open-label study in healthy volunteers.

    Science.gov (United States)

    Portolés, Antonio; Almeida, Susana; Terleira, Ana; de Pablo, Itziar; Filipe, Augusto; Cruz Caturla, Maria; Moreno, Alfonso

    2004-01-01

    The bioequivalence of two capsule formulations (test and reference) containing 200 mg fluconazole (CAS 86386-73-4) was assessed in 24 healthy volunteers in an open, randomised, crossover, 2 periods x 2 sequences single dose study with a minimum washout period of 14 days. Plasma samples were obtained over 168 h (at baseline, 1 h, 2 h, 2.5 h, 3 h, 3.5 h, 4 h, 5 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 120 h and 168 h after administration) and fluconazole concentrations were determined by means of an HPLC-WV method (limit of quantification: 0.2 microg/mL). Pharmacokinetic parameters used for bioequivalence assessment (AUClast, AUCinf and Cmax) were determined from the fluconazole concentration data using non-compartmental analysis. The results showed that all 90% confidence intervals (obtained by ANOVA) were 100.89-110.24 for Cmax, 99.07-107.35 for AUClast and 95.42-105.17 for AUCinf, that is, all within the predefined ranges. Furthermore AUCs truncated at 24, 48, 72 and 120 h were also within the 80-125% range. It may be therefore concluded that the evaluated formulations are bioequivalent in terms of rate and extent of absorption.

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

    Science.gov (United States)

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

    2014-10-01

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

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

    Directory of Open Access Journals (Sweden)

    T N A van den Berg

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

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

    Science.gov (United States)

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

    2015-01-01

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

  17. Tablet computers with mobile electronic medical records enhance clinical routine and promote bedside time: a controlled prospective crossover study.

    Science.gov (United States)

    Fleischmann, Robert; Duhm, Julian; Hupperts, Hagen; Brandt, Stephan A

    2015-03-01

    Demographic changes require physicians to deliver needed services with fewer resources. Neurology as an interdisciplinary domain involves complex diagnostic procedures and time-consuming data handling. Tablet PCs might streamline clinical workflow through mobile access to patient data. This study examined the impact of tablets running an electronic medical record on ward round performance. We hypothesised that tablet use should reduce ward round time and decrease the time needed to check medical records thereby increasing physicians' bedside availability. Nine resident neurologists participated in a controlled prospective crossover trial over 14 weeks. In the experimental condition, tablets were used in addition to the established medical record. In the control condition, physicians used established systems only. The combined primary outcome measure included changes in total ward round time and relative time shifts between associated work processes. The secondary outcome measure was physicians' time required to check a medical record vs. physicians' bedside time. There was a significant main effect on the primary outcome measure (p = 0.01). Tablet use accelerated preparing (p = 0.004) and post-processing (p Time for conducting ward rounds was unaffected (p = 0.19). Checking medical records was faster with tablets (p = 0.001) increasing physicians' bedside time (p time savings during preparing and post-processing of ward rounds. It was further associated with time savings during checking medical data and an increase in physicians' bedside time. Tablets may facilitate clinical data handling and promote workflow.

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

    Science.gov (United States)

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

    2013-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Tyseer M. F. Marzouk

    2013-01-01

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

  20. Oxygen administration selectively enhances cognitive performance in healthy young adults: a placebo-controlled double-blind crossover study.

    Science.gov (United States)

    Moss, M C; Scholey, A B; Wesnes, K

    1998-07-01

    It was recently demonstrated that oxygen administration can improve performance on a simple word recall task in healthy young adults. This study was aimed at determining the impact of various durations of oxygen administration on a wider range of cognitive measures. This was achieved using the Cognitive Drug Research computerised test battery, and employing a double-blind, placebo-controlled crossover design. Over a period of 7 weeks, 20 participants were trained and subsequently assessed on the test battery under several durations of oxygen inhalation; air administered in an identical fashion served as a control. The results provided support for our earlier work in that increases were found in both immediate and delayed word recall. In addition, oxygen administration significantly improved performance on several measures of attention and vigilance. Simple reaction time, choice reaction time, digit vigilance reaction time and picture recognition reaction time were improved in a manner which depended on the duration of oxygen inspired. With the exception of word recall, no significant improvements were found for any measure of accuracy, nor were word recognition, digit memory scanning, or spatial memory improved. These results are discussed in the context of stages of information processing and are consistent with the hypothesis that cognitive performance is "fuel-limited" and can be differentially augmented by increasing the availability of the brain's metabolic resources.

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

    Directory of Open Access Journals (Sweden)

    Chaveewan Ratanajamit

    2017-06-01

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

  2. Safety and efficacy of vardenafil versus sertraline in the treatment of premature ejaculation: a randomised, prospective and crossover study.

    Science.gov (United States)

    Mathers, M J; Klotz, T; Roth, S; Lümmen, G; Sommer, F

    2009-06-01

    We investigated safety and efficacy of vardenafil and sertraline in premature ejaculation (PE). Seventy-two men graded their primary PE on a scale of 0-8 (0 = almost never, 8 = almost always). Intravaginal ejaculatory latency time (IELT) was measured. Patients were included if they scored their PE as 4 or greater and their IELTs were less than 1.30 min. After 6 weeks of behavioural psychosexual therapy, 49 patients still had a PE of 4 or greater and an IELT less than 1.30 min and they were randomised: 6 weeks vardenafil (10 mg) or sertraline (50 mg). After a wash-out phase for 1 week, medication was changed in a cross-over design. Initially, all 72 men with PE received behavioural therapy. Twenty-three men were satisfied with treatment and excluded. The remaining 49 men graded their PE as 5.94 +/- 1.6 and IELT was 0.59 min and patients were randomised. Four men discontinued the study. Vardenafil improved PE grading: 2.7 +/- 2.1 (P IELT increased to 5.01 +/- 3.69 (P IELT 3.12 +/- 1.89 (P < 0.001) with sertraline. It is concluded that vardenafil and sertraline are useful agents in the pharmacological treatment of PE.

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

    Science.gov (United States)

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

    2017-05-01

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

  4. Gaseous air pollution and acute myocardial infarction mortality in Hong Kong: A time-stratified case-crossover study

    Science.gov (United States)

    Lin, Hualiang; An, Qingzhu; Luo, Chao; Pun, Vivian C.; Chan, Chi Sing; Tian, Linwei

    2013-09-01

    Acute myocardial infarction (AMI) is a common disease with serious consequences in mortality and morbidity. An association between gaseous air pollution and AMI has been suggested, but the epidemiological evidence is still limited. For the study period 1998-2010, daily counts of AMI deaths were collected, as well as daily air pollution data including concentrations of particulates (PM10), nitrogen dioxide (NO2), sulfur dioxide (SO2), ozone (O3) and carbon monoxide (CO) were also obtained. The associations between gaseous air pollutants and AMI mortality were estimated using time-stratified case-crossover analyses. NO2 and SO2 were found to be significantly associated with increased AMI mortality. The odds ratios (ORs) were 1.0455 (95% confidence interval (CI): 1.017-1.0748) and 1.0256 (95% CI: 1.0027-1.0489) for an interquartile range (IQR) increase in the current day's NO2 and SO2 concentration, respectively, and this association persisted in 2-pollutant models; and no association was observed for CO and O3. It is likely that exposure to elevated ambient NO2 and SO2 air pollution contributed to increased AMI mortality.

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

    Directory of Open Access Journals (Sweden)

    Wen-Dien Chang

    2015-01-01

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

  6. The Tulip GT® airway versus the facemask and Guedel airway: a randomised, controlled, cross-over study by Basic Life Support-trained airway providers in anaesthetised patients.

    Science.gov (United States)

    Shaikh, A; Robinson, P N; Hasan, M

    2016-03-01

    We performed a randomised, controlled, cross-over study of lung ventilation by Basic Life Support-trained providers using either the Tulip GT® airway or a facemask with a Guedel airway in 60 anaesthetised patients. Successful ventilation was achieved if the provider produced an end-tidal CO2 > 3.5 kPa and a tidal volume > 250 ml in two of the first three breaths, within 60 sec and within two attempts. Fifty-seven (95%) providers achieved successful ventilation using the Tulip GT compared with 35 (58%) using the facemask (p Tulip GT and facemask, the mean (SD) end-tidal CO2 was 5.0 (0.7) kPa vs 2.5 (1.5) kPa, tidal volume was 494 (175) ml vs 286 (186) ml and peak inspiratory pressure was 18.3 (3.4) cmH2 O vs 13.6 (7) cmH2 O respectively (all p Tulip GT airway. These results are similar to a previous manikin study using the same protocol, suggesting a close correlation between human and manikin studies for this airway device. We conclude that the Tulip GT should be considered as an adjunct to airway management both within and outside hospitals when ventilation is being undertaken by Basic Life Support-trained airway providers. © 2015 The Association of Anaesthetists of Great Britain and Ireland.

  7. A Single-Dose, Two-Way Crossover, Open-Label Bioequivalence Study of an Amphetamine Extended-Release Oral Suspension in Healthy Adults.

    Science.gov (United States)

    Sikes, Carolyn; Stark, Jeffrey G; McMahen, Russ; Engelking, Dorothy

    2017-11-01

    The purpose of this study was to compare the pharmacokinetics of a new extended-release amphetamine oral suspension (AMP XR-OS) with a standard extended-release mixed amphetamine salts product, Adderall XR®. In this single-dose, open-label, randomized, two-period, two-treatment crossover study, 42 healthy adult volunteers received 15 mL of AMP XR-OS in one period and a 30 mg Adderall XR capsule in another period (both containing 18.8 mg of amphetamine base) under fasted conditions. Blood samples were analyzed for d- and l-amphetamine concentrations, and pharmacokinetic parameters Cmax, AUC0-5, AUC5-last, and AUCinf were calculated to determine bioequivalence. Safety was monitored throughout the study. The 90% confidence intervals (CIs) for the log-transformed Cmax, AUC0-5, AUC5-last, and AUCinf fell within the accepted 80% to 125% range for establishing bioequivalence for d- and l-amphetamine. The most common adverse events were nausea and decreased appetite. AMP XR-OS is bioequivalent to Adderall XR in healthy adult participants.

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

    Science.gov (United States)

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

    2017-11-01

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

  9. Celecoxib in the treatment of primary dysmenorrhea: results from two randomized, double-blind, active- and placebo-controlled, crossover studies.

    Science.gov (United States)

    Daniels, Stephen; Robbins, Jeffery; West, Christine R; Nemeth, Mary Anne

    2009-06-01

    Celecoxib, a cyclooxygenase-2 inhibitor, has established analgesic efficacy for the treatment of acute pain resulting from a variety of causes. This article describes 2 studies designed to assess the efficacy and tolerability of celecoxib in patients with primary dysmenorrhea. Two identical, 3-day, multiple-dose, randomized, double-blind, active- and placebo-controlled, crossover studies were carried out in women aged 18 to 44 years with primary dysmenorrhea (studies 1 and 2). The studies employed a 6-sequence, 3-period, complete-block crossover design over 3 menstrual cycles. Patients received celecoxib 400 mg, followed by celecoxib 200 mg no sooner than 12 hours after first dose (day 1), then celecoxib 200 mg q12h as necessary (days 2 and 3); naproxen sodium 550 mg followed by naproxen sodium 550 mg no sooner than 12 hours after first dose (day 1), then naproxen sodium 550 mg q12h as necessary (days 2 and 3); or placebo. Primary efficacy measures were time-weighted sum of total pain relief and time-weighted sum of pain intensity difference at 8 hours after administration of the first dose of study medication (TOTPAR[8] and SPID[8], respectively). Tolerability was assessed using routine physical examination, including vital sign measurements, and clinical laboratory analyses at screening and end of study. In total, 149 and 154 patients were randomized to 1 of the 6 treatment sequences in studies 1 and 2, respectively. Across treatment sequences, mean age ranges were 23.4 to 26.9 years (study 1) and 28.3 to 34.1 years (study 2). Mean weight ranges were 62.7 to 74.5 kg (study 1) and 69.2 to 86.7 kg (study 2). Most patients (96.6% in study 1, 80.5% in study 2) were white. Mean TOTPAR[8] values with celecoxib (study 1/study 2, 18.28/17.98) and naproxen sodium (20.59/21.27) were significantly greater than with placebo (12.82/12.98) (all, P < 0.001). Mean SPID[8] values were significantly greater with celecoxib (10.06/9.60) and naproxen sodium (11.48/11.71) than with

  10. Association between flood and the morbidity of bacillary dysentery in Zibo City, China: a symmetric bidirectional case-crossover study

    Science.gov (United States)

    Zhang, Feifei; Ding, Guoyong; Liu, Zhidong; Zhang, Caixia; Jiang, Baofa

    2016-12-01

    This study examined the relationship between daily morbidity of bacillary dysentery and flood in 2007 in Zibo City, China, using a symmetric bidirectional case-crossover study. Odds ratios (ORs) and 95 % confidence intervals (CIs) on the basis of multivariate model and stratified analysis at different lagged days were calculated to estimate the risk of flood on bacillary dysentery. A total of 902 notified bacillary dysentery cases were identified during the study period. The median of case distribution was 7-year-old and biased to children. Multivariable analysis showed that flood was associated with an increased risk of bacillary dysentery, with the largest OR of 1.849 (95 % CI 1.229-2.780) at 2-day lag. Gender-specific analysis showed that there was a significant association between flood and bacillary dysentery among males only (ORs >1 from lag 1 to lag 5), with the strongest lagged effect at 2-day lag (OR = 2.820, 95 % CI 1.629-4.881), and the result of age-specific indicated that youngsters had a slightly larger risk to develop flood-related bacillary dysentery than older people at one shorter lagged day (OR = 2.000, 95 % CI 1.128-3.546 in youngsters at lag 2; OR = 1.879, 95 % CI 1.069-3.305 in older people at lag 3). Our study has confirmed that there is a positive association between flood and the risk of bacillary dysentery in selected study area. Males and youngsters may be the vulnerable and high-risk populations to develop the flood-related bacillary dysentery. Results from this study will provide recommendations to make available strategies for government to deal with negative health outcomes due to floods.

  11. Association between flood and the morbidity of bacillary dysentery in Zibo City, China: a symmetric bidirectional case-crossover study.

    Science.gov (United States)

    Zhang, Feifei; Ding, Guoyong; Liu, Zhidong; Zhang, Caixia; Jiang, Baofa

    2016-12-01

    This study examined the relationship between daily morbidity of bacillary dysentery and flood in 2007 in Zibo City, China, using a symmetric bidirectional case-crossover study. Odds ratios (ORs) and 95 % confidence intervals (CIs) on the basis of multivariate model and stratified analysis at different lagged days were calculated to estimate the risk of flood on bacillary dysentery. A total of 902 notified bacillary dysentery cases were identified during the study period. The median of case distribution was 7-year-old and biased to children. Multivariable analysis showed that flood was associated with an increased risk of bacillary dysentery, with the largest OR of 1.849 (95 % CI 1.229-2.780) at 2-day lag. Gender-specific analysis showed that there was a significant association between flood and bacillary dysentery among males only (ORs >1 from lag 1 to lag 5), with the strongest lagged effect at 2-day lag (OR = 2.820, 95 % CI 1.629-4.881), and the result of age-specific indicated that youngsters had a slightly larger risk to develop flood-related bacillary dysentery than older people at one shorter lagged day (OR = 2.000, 95 % CI 1.128-3.546 in youngsters at lag 2; OR = 1.879, 95 % CI 1.069-3.305 in older people at lag 3). Our study has confirmed that there is a positive association between flood and the risk of bacillary dysentery in selected study area. Males and youngsters may be the vulnerable and high-risk populations to develop the flood-related bacillary dysentery. Results from this study will provide recommendations to make available strategies for government to deal with negative health outcomes due to floods.

  12. Temperature crossovers in cuprates

    Energy Technology Data Exchange (ETDEWEB)

    Chubukov, Andrey V. [Department of Physics, University of Wisconsin, Madison, WI (United States); Pines, David; Stojkovic, Branko P. [Department of Physics, University of Illinois, Urbana, IL (United States)

    1996-11-25

    We study the temperature crossovers seen in the magnetic and transport properties of cuprates using a nearly antiferromagnetic Fermi-liquid model (NAFLM). We distinguish between underdoped and overdoped systems on the basis of their low-frequency magnetic behaviour and so classify the optimally doped cuprates as a special case of the underdoped cuprates. For the overdoped cuprates, we find, in agreement with earlier work, mean-field z=2 behaviour of the magnetic variables associated with the fact that the damping rate of their spin fluctuations is essentially independent of temperature, while the resistivity exhibits a crossover from Fermi-liquid behaviour at low temperature to linear-in-T behaviour above a certain temperature T{sub o}. We demonstrate that above T{sub o} the proximity of the quasiparticle Fermi surface to the magnetic Brillouin zone boundary brings about the measured linear-in-T resistivity. For the underdoped cuprates we argue that the sequence of crossovers identified by Barzykin and Pines in the low-frequency magnetic behaviour (from mean-field z=2 behaviour at high temperatures, T>T{sub cr}, to non-universal z=1 scaling behaviour at intermediate temperatures, T{sub *}

  13. An Interventional Study Comparing the Memory Retention of Verbal & Pictorial Materials among MMMC Students

    OpenAIRE

    Khoo Jing Hern; Muhammad Khairul Anwar bin Mohd Yusof; Fatin Nuraidil binti Zaifulbahri; Nurfarah Aini binti Azahar; Grace Sugumaran; Navin Kumar Sarkunam

    2017-01-01

    Aims: To compare the effectiveness of pictorial against verbal materials in memory retention among medical students. Study Design: Crossover randomized controlled trial. Place and Duration of Study: This study was conducted in Melaka-Manipal Medical College, Muar, Johor, Malaysia in April 2016. Methodology: 38 right-handed medical students of Melaka-Manipal Medical College were volunteers and participants were divided into two groups equally via simple random sampling. One group o...

  14. The effects of breakfast on short-term cognitive function among Chinese white-collar workers: protocol for a three-phase crossover study

    OpenAIRE

    Zhenchuang Tang; Na Zhang; Ailing Liu; Dechun Luan; Yong Zhao; Chao Song; Guansheng Ma

    2017-01-01

    Abstract Background As the first meal of the day, breakfast plays an important role in supplying energy and nutrients, which are critical to working and learning activities. A three-phase crossover study was designed to investigate the effects of breakfast on cognitive function among Chinese white-collar workers. The planned study protocol is presented. Methods A total of 264 participants aged 25–45 years will be recruited from Shenyang and Chongqing. Self-administered questionnaires will be ...

  15. The effects of breakfast on short-term cognitive function among Chinese white-collar workers: protocol for a three-phase crossover study

    OpenAIRE

    Tang, Zhenchuang; Zhang, Na; Liu, AiLing; Luan, Dechun; Zhao, Yong; Song, Chao; Ma, Guansheng

    2017-01-01

    Background As the first meal of the day, breakfast plays an important role in supplying energy and nutrients, which are critical to working and learning activities. A three-phase crossover study was designed to investigate the effects of breakfast on cognitive function among Chinese white-collar workers. The planned study protocol is presented. Methods A total of 264 participants aged 25?45 years will be recruited from Shenyang and Chongqing. Self-administered questionnaires will be used to c...

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

    OpenAIRE

    Jakobsen, Ida; Solomon, Thomas P.J.; Karstoft, Kristian

    2016-01-01

    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 5...

  17. Effects of Transcranial Direct Current Stimulation, Transcranial Pulsed Current Stimulation, and Their Combination on Brain Oscillations in Patients with Chronic Visceral Pain: A Pilot Crossover Randomized Controlled Study

    Directory of Open Access Journals (Sweden)

    Aurore Thibaut

    2017-11-01

    Full Text Available ObjectiveChronic visceral pain (CVP syndromes are persistently painful disorders with a remarkable lack of effective treatment options. This study aimed at evaluating the effects of different neuromodulation techniques in patients with CVP on cortical activity, through electreocephalography (EEG and on pain perception, through clinical tests.DesignA pilot crossover randomized controlled study.SettingsOut-patient.SubjectsAdults with CVP (>3 months.MethodsParticipants received four interventions in a randomized order: (1 transcranial pulsed current stimulation (tPCS and active transcranial direct current stimulation (tDCS combined, (2 tPCS alone, (3 tDCS alone, and (4 sham condition. Resting state quantitative electroencephalography (qEEG and pain assessments were performed before and after each intervention. Results were compared with a cohort of 47 healthy controls.ResultsWe enrolled six patients with CVP for a total of 21 visits completed. Compared with healthy participants, patients with CVP showed altered cortical activity characterized by increased power in theta, alpha and beta bands, and a significant reduction in the alpha/beta ratio. Regarding tES, the combination of tDCS with tPCS had no effect on power in any of the bandwidths, nor brain regions. Comparing tPCS with tDCS alone, we found that tPCS induced higher increase in power within the theta and alpha bandwidths.ConclusionThis study confirms that patients with CVP present abnormal EEG-indexed cortical activity compared with healthy controls. Moreover, we showed that combining two types of neurostimulation techniques had no effect, whereas the two interventions, when applied individually, have different neural signatures.

  18. Comparison of different exposure settings in a case--crossover study on air pollution and daily mortality: counterintuitive results.

    Science.gov (United States)

    Zauli Sajani, Stefano; Hänninen, Otto; Marchesi, Stefano; Lauriola, Paolo

    2011-01-01

    Because of practical problems associated with measurement of personal exposures to air pollutants in larger populations, almost all epidemiological studies assign exposures based on fixed-site ambient air monitoring stations. In the presence of multiple monitoring stations at different locations, the selection of them may affect the observed epidemiological concentration--response (C-R) relationships. In this paper, we quantify these impacts in an observational ecologic case--crossover study of air pollution and mortality. The associations of daily concentrations of PM(10), O(3), and NO(2) with daily all-cause non-violent mortality were investigated using conditional logistic regression to estimate percent increase in the risk of dying for an increase of 10 μg/m(3) in the previous day air pollutant concentrations (lag 1). The study area covers the six main cities in the central-western part of Emilia-Romagna region (population of 1.1 million). We used four approaches to assign exposure to air pollutants for each individual considered in the study: nearest background station; city average of all stations available; average of all stations in a macro-area covering three cities and average of all six cities in the study area (50 × 150 km(2)). Odds ratios generally increased enlarging the spatial dimension of the exposure definition and were highest for six city-average exposure definition. The effect is especially evident for PM(10), and similar for NO(2), whereas for ozone, we did not find any change in the C-R estimates. Within a geographically homogeneous region, the spatial aggregation of monitoring station data leads to higher and more robust risk estimates for PM(10) and NO(2), even if monitor-to-monitor correlations showed a light decrease with distance. We suggest that the larger aggregation improves the representativity of the exposure estimates by decreasing exposure misclassification, which is more profound when using individual stations vs regional

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

    Science.gov (United States)

    Shi, Yuanlu; Williamson, Gary

    2015-05-01

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

  20. Effects of toe and ankle training in older people: a cross-over study.

    OpenAIRE

    Nagai, Koutatsu; Inoue, Takuya; Yamada, Yosuke; Tateuchi, Hiroshige; Ikezoe, Tome; Ichihashi, Noriaki; Tsuboyama, Tadao

    2011-01-01

    Maintenance of physical function in the elderly is important. Previous studies have focused mainly on training-center-based interventions, accompanied by training staff or equipped with training machinery. The purpose of this study was to investigate the effects of toe and ankle training for the elderly.

  1. Mössbauer thermal scan study of a spin crossover system

    Science.gov (United States)

    Mendoza Zélis, P.; Pasquevich, G. A.; Sánchez, F. H.; Veiga, A.; Ceolin, M.; Cabrera, A. F.; Coronado-Miralles, E.; Monrabal-Capilla, M.; Galan-Mascaros, J. R.

    2010-03-01

    Programmable Velocity equipment was used to perform a Mössbauer Thermal Scans to allow a quasi-continuous temperature study of the magnetic transition between the low-spin and a high-spin configurations in [Fe(Htrz)2(trz)](BF4) system. The material was studied both in bulk as in nanoparticles sample forms.

  2. Work-related psychosocial events as triggers of sick leave - results from a Swedish case-crossover study

    Directory of Open Access Journals (Sweden)

    Lindholm Christina

    2011-03-01

    Full Text Available Abstract Background Although illness is an important cause of sick leave, it has also been suggested that non-medical risk factors may influence this association. If such factors impact on the period of decision making, they should be considered as triggers. Yet, there is no empirical support available. The aim was to investigate whether recent exposure to work-related psychosocial events can trigger the decision to report sick when ill. Methods A case-crossover design was applied to 546 sick-leave spells, extracted from a Swedish cohort of 1 430 employees with a 3-12 month follow-up of new sick-leave spells. Exposure in a case period corresponding to an induction period of one or two days was compared with exposure during control periods sampled from workdays during a two-week period prior to sick leave for the same individual. This was done according to the matched-pair interval and the usual frequency approaches. Results are presented as odds ratios (OR with 95% confidence intervals (CI. Results Most sick-leave spells happened in relation to acute, minor illnesses that substantially reduced work ability. The risk of taking sick leave was increased when individuals had recently been exposed to problems in their relationship with a superior (OR 3.63; CI 1.44-9.14 or colleagues (OR 4.68; CI 1.43-15.29. Individuals were also more inclined to report sick on days when they expected a very stressful work situation than on a day when they were not under such stress (OR 2.27; CI 1.40-3.70. Conclusions Exposure to problems in workplace relationships or a stressful work situation seems to be able to trigger reporting sick. Psychosocial work-environmental factors appear to have a short-term effect on individuals when deciding to report sick.

  3. Oxytocin treatment in children with Prader-Willi syndrome: A double-blind, placebo-controlled, crossover study.

    Science.gov (United States)

    Miller, Jennifer L; Tamura, Roy; Butler, Merlin G; Kimonis, Virginia; Sulsona, Carlos; Gold, June-Anne; Driscoll, Daniel J

    2017-05-01

    Prader-Willi syndrome (PWS) is a rare, complex multisystem genetic disorder which includes hypothalamic dysfunction, hyperphagia, cognitive and behavioral problems, increased anxiety, and compulsive behaviors. Individuals with PWS have a deficit of oxytocin producing neurons in the paraventricular nucleus of the hypothalamus. Oxytocin plays a role in regulation of feeding behaviors, social interactions, and emotional reactivity, which are all issues that significantly affect the quality of life for individuals with this syndrome. We performed a double-blind, placebo-controlled, crossover study in 24 children with PWS at three academic institutions using 5 days of intranasal oxytocin (IN-OT) or 5 days of intranasal placebo spray, followed by a 4 week washout period, and then patients returned for 5 days of treatment with the alternate source. Questionnaires, including the Aberrant Behavior Checklist, Social Responsiveness Scale, Repetitive Behavior Scale - Revised, and the Hyperphagia Questionnaire, as well as Clinical Global Impression scales were administered. Blood testing for sodium, potassium, and glucose levels on days 2, 4, and 6, and a 24 hr diet recall. All scales factor improvement from Day 3 to Day 6 favored oxytocin over placebo. No single factor showed a statistically significant difference (P oxytocin and placebo in safety lab parameters, 60 min post dose vital signs, weight, or diet parameters. The results from this study suggest that low dose intranasal oxytocin is safe for individuals with PWS and may result in reduction in appetite drive, and improvements in socialization, anxiety, and repetitive behaviors. Further, long-term studies with a larger population of participants are necessary to confirm these findings. The results of this study are encouraging that oxytocin may be a safe and effective treatment for many of the issues that negatively impact individuals with PWS. © 2017 Wiley Periodicals, Inc.

  4. Prescription medicine use by pedestrians and the risk of injurious road traffic crashes: A case-crossover study.

    Directory of Open Access Journals (Sweden)

    Mélanie Née

    2017-07-01

    Full Text Available While some medicinal drugs have been found to affect driving ability, no study has investigated whether a relationship exists between these medicines and crashes involving pedestrians. The aim of this study was to explore the association between the use of medicinal drugs and the risk of being involved in a road traffic crash as a pedestrian.Data from 3 French nationwide databases were matched. We used the case-crossover design to control for time-invariant factors by using each case as its own control. To perform multivariable analysis and limit false-positive results, we implemented a bootstrap version of Lasso. To avoid the effect of unmeasured time-varying factors, we varied the length of the washout period from 30 to 119 days before the crash. The matching procedure led to the inclusion of 16,458 pedestrians involved in an injurious road traffic crash from 1 July 2005 to 31 December 2011. We found 48 medicine classes with a positive association with the risk of crash, with median odds ratios ranging from 1.12 to 2.98. Among these, benzodiazepines and benzodiazepine-related drugs, antihistamines, and anti-inflammatory and antirheumatic drugs were among the 10 medicines most consumed by the 16,458 pedestrians. Study limitations included slight overrepresentation of pedestrians injured in more severe crashes, lack of information about self-medication and the use of over-the-counter drugs, and lack of data on amount of walking.Therapeutic classes already identified as impacting the ability to drive, such as benzodiazepines and antihistamines, are also associated with an increased risk of pedestrians being involved in a road traffic crash. This study on pedestrians highlights the necessity of improving awareness of the effect of these medicines on this category of road user.

  5. The contribution of prescription chart design and familiarity to prescribing error: a prospective, randomised, cross-over study.

    Science.gov (United States)

    Tallentire, Victoria R; Hale, Rebecca L; Dewhurst, Neil G; Maxwell, Simon R J

    2013-10-01

    Initiatives to standardise hospital paper-based prescription charts are underway in various countries in an effort to reduce prescribing errors. The aim of this study was to investigate the extent to which prescribing error rates are influenced by prescription chart design and familiarity. In this prospective, randomised, cross-over study, Foundation Year 1 doctors working in five Scottish National Health Service (NHS) Boards participated in study sessions during which they were asked to prescribe lists of medications for five fictional patients using a different design of paper prescription chart for each patient. Each doctor was timed completing each set of prescriptions, and each chart was subsequently assessed against a predefined list of possible errors. A mixed modelling approach using three levels of variables (design of and familiarity with a chart, prescribing speed and individual prescriber) was employed. A total of 72 Foundation Year 1 doctors participated in 10 data-collection sessions. Differences in prescription chart design were associated with significant variations in the rates of prescribing error. The charts from NHS Highland and NHS Grampian produced significantly higher error rates than the other three charts. Participants who took longer to complete their prescriptions made significantly fewer errors, but familiarity with a chart did not predict error rate. This study has important implications for prescription chart design and prescribing education. The inverse relationship between the time taken to complete a prescribing task and the rate of error emphasises the importance of attention to detail and workload as factors in error causation. Further work is required to identify the characteristics of prescription charts that are protective against errors.

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

    Science.gov (United States)

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

    2017-04-01

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

  7. Manual Closed-Loop Insulin Delivery Using a Saddle Point Model Predictive Control Algorithm: Results of a Crossover Randomized Overnight Study.

    Science.gov (United States)

    Guilhem, Isabelle; Penet, Maxime; Paillard, Anaïs; Carpentier, Marc; Esvant, Annabelle; Lefebvre, Marie-Anne; Poirier, Jean-Yves

    2017-09-01

    The purpose was to assess the efficacy of a new closed-loop algorithm (Saddle Point Model Predictive Control, SP-MPC) in achieving nocturnal normoglycemia while reducing the risk of hypoglycemia in patients with type 1 diabetes. In this randomized crossover study, 10 adult patients (mean hemoglobin A1c 7.35 ± 1.04%) were assigned to be treated overnight by open loop using sensor-augmented pump therapy (open-loop SAP) or manual closed-loop delivery. During closed loop, insulin doses were calculated using the SP-MPC algorithm and administered as manual boluses every 15 minutes from 9:00 pm to 8:00 am. Patients consumed a self-selected meal (65-125 g of carbohydrates) at 7:00 pm accompanied by their usual prandial bolus. Blood glucose was measured every 30 minutes. The primary endpoints were the time spent in target (70-145 mg/dl) and time spent below 70 mg/dl from 11:00 pm to 8:00 am. Time spent in target did not differ between closed-loop and open-loop SAP. The number of hypoglycemic events (145 mg/dl was significantly lower during closed-loop than during open-loop SAP ( P = .03) as well as HBGI ( P = .02). This pilot study suggests that the use of the SP-MPC algorithm may improve mean overnight glucose control and reduce the number of hypoglycemic events as compared to SAP therapy.

  8. Effects of chocolate-based products intake on blood glucose, insulin and ghrelin levels and on satiety in young people: a cross-over experimental study.

    Science.gov (United States)

    Zhang, Cai-Xia; Long, Wei-Qing; Ye, Yan-Bin; Lu, Min-Shan; Zhang, Nai-Qi; Xu, Ming; Huang, Jing; Su, Yi-Xiang

    2018-02-19

    This cross-over experimental study aimed to examine the effects of filled chocolate consumption on blood glucose, insulin and ghrelin levels in 20 volunteers. After a one-week run-in period, study participants consumed two chocolate-based products, the tested biscuit or water for 21 days as a morning snack. After a two-week wash-out period, participants consumed another tested food for another 21 days. Each participant consumed all four test foods within an 18-week period. The participants' blood insulin increased slowly after two chocolate-based products intakes on the first day and satiety levels after eating chocolate-based products and the tested biscuit were the same. Chocolate consumption for three weeks had no adverse effects on blood glucose, insulin or ghrelin levels. In conclusion, compared to eating the tested biscuit, 21-day consumption of the tested chocolate-based products had no adverse effects on the blood glucose, insulin and ghrelin levels. This trial is registered with chictr.org.cn: ChiCTR-IOR-16009525.

  9. The amelioration of plasma lipids by Korean traditional confectionery in middle-aged women: A cross-over study with western cookie.

    Science.gov (United States)

    Hong, Sun Hee; Kim, Mijeong; Woo, Minji; Noh, Jeong Sook; Lee, JaeHwan; Chung, Lana; Song, Yeong Ok

    2016-12-01

    The purpose of this study was to examine whether plasma lipid profiles are affected differently by snack kinds with equal calorific values. We compared a Korean traditional confectionery ( dasik ) with Western confectionery (cookie) in this regard. Controlled cross-over study consisted of two 3-week snack intake phases and for separating, a 2-week washout period (3-2-3) was carried out with 30 healthy women aged between 40-59 years old. Brown rice based Korean traditional confectionery and wheat flour based Western confectionery were used. The participants consumed either dasik or cookie every day for 3 weeks, providing 93 kcal a day. The total cholesterol (TC) in the dasik group had decreased significantly after 3 weeks ( P < 0.05). Furthermore, in the dasik group, reduction in TC and low-density lipoprotein-cholesterol were greater than those in the cookie group ( P < 0.05). Prioritizing functional snacks like dasik improves plasma lipid profiles; this may be useful information for individuals who cannot refrain from snacking.

  10. An intercomparison of dissolved iron speciation at the Bermuda Atlantic Time-series Study (BATS site: Results from GEOTRACES Crossover Station A

    Directory of Open Access Journals (Sweden)

    Kristen Nicolle Buck

    2016-12-01

    Full Text Available The organic complexation of dissolved iron (Fe was determined in depth profile samples collected from GEOTRACES Crossover Station A, the Bermuda Atlantic Time-series Study (BATS site, as part of the Dutch and U.S. GEOTRACES North Atlantic programs in June 2010 and November 2011, respectively. The two groups employed distinct competitive ligand exchange-adsorptive cathodic stripping voltammetry (CLE-AdCSV methods, and resulting ligand concentrations and conditional stability constants from each profile were compared. Excellent agreement was found between the total ligand concentrations determined in June 2010 and the strongest, L1-type, ligand concentrations determined in November 2011. Yet a primary distinction between the datasets was the number of ligand classes observed: a single ligand class was characterized in the June 2010 profile while two ligand classes were observed in the November 2011 profile. To assess the role of differing interpretation approaches in determining final results, analysts exchanged titration data and accompanying parameters from the profiles for reinterpretation. The reinterpretation exercises highlighted the considerable influence of the sensitivity (S parameter applied on interpretation results, consistent with recent intercalibration work on interpretation of copper speciation titrations. The potential role of titration data structure, humic-type substances, differing dissolved Fe concentrations, and seasonality are also discussed as possible drivers of the one versus two ligand class determinations between the two profiles, leading to recommendations for future studies of Fe-binding ligand cycling in the oceans.

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

    National Research Council Canada - National Science Library

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

    2016-01-01

    .... Pirfenidone is a drug with biological, anti-inflammatory, and antifibrotic effects. The aim of this study was to evaluate the effect of topical pirfenidone added to conventional treatment in noninfected chronic diabetic foot ulcers...

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

    DEFF Research Database (Denmark)

    Momsen, A H; Jensen, M B; Norager, C B

    2010-01-01

    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.......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....

  13. Apparent temperature and acute myocardial infarction hospital admissions in Copenhagen, Denmark: a case-crossover study

    DEFF Research Database (Denmark)

    Wichmann, Janine; Ketzel, Matthias; Ellermann, Thomas

    2012-01-01

    The influence of temperature on acute myocardial infarction (AMI) has not been investigated as extensively as the effects of broader outcomes of morbidity and mortality. Sixteen studies reported inconsistent results and two considered confounding by air pollution. We addressed some of the methodo......The influence of temperature on acute myocardial infarction (AMI) has not been investigated as extensively as the effects of broader outcomes of morbidity and mortality. Sixteen studies reported inconsistent results and two considered confounding by air pollution. We addressed some...

  14. A Novel Magnetic Stimulator Increases Experimental Pain Tolerance in Healthy Volunteers - A Double-Blind Sham-Controlled Crossover Study

    Science.gov (United States)

    Kortekaas, Rudie; Konopka, Karl-Heinz; Harbers, Marten; van der Hoeven, Johannes H.; van Wijhe, Marten; Aleman, André; Maurits, Natasha M.

    2013-01-01

    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 PMID:23620795

  15. The Effects of Coarse Particles on Daily Mortality: A Case-Crossover Study in a Subtropical City, Taipei, Taiwan

    Directory of Open Access Journals (Sweden)

    Meng-Hsuan Cheng

    2016-03-01

    Full Text Available Many studies have examined the effects of air pollution on daily mortality over the past two decades. However, information on the relationship between levels of coarse particles (PM2.5–10 and daily mortality is relatively sparse due to the limited availability of monitoring data. Furthermore, the results are inconsistent. In the current study, the association between coarse particle levels and daily mortality in Taipei, Taiwan’s largest city, which has a subtropical climate, was undertaken for the period 2006–2008 using a time-stratified case-crossover analysis. For the single pollutant model (without adjustment for other pollutants, PM2.5–10 showed statistically significant association with total mortality both on warm and cool days, with an interquartile range increase associated with a 11% (95% CI = 6%–17% and 4% (95% CI = 1%–7% rise in number of total deaths, respectively. In two-pollutant models, PM2.5–10 remained significant effects on total mortality after the inclusion of SO2 and O3 both on warm and cool days. We observed no significant associations between PM2.5–10 and daily mortality from respiratory diseases both on warm and cool days. For daily mortality from circulatory diseases, the effect of PM2.5–10 remained significant when SO2 or O3 was added in the regression model both on warm and cool days. Future studies of this type in cities with varying climates and cultures are needed.

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

    Science.gov (United States)

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

    2013-11-01

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

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

    Directory of Open Access Journals (Sweden)

    Merav Catalogna

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

  18. Upper gastrointestinal bleeding due to peptic ulcer disease is not associated with air pollution: a case-crossover study.

    Science.gov (United States)

    Quan, Samuel; Yang, Hong; Tanyingoh, Divine; Villeneuve, Paul J; Stieb, David M; Johnson, Markey; Hilsden, Robert; Madsen, Karen; van Zanten, Sander Veldhuyzen; Novak, Kerri; Lang, Eddy; Ghosh, Subrata; Kaplan, Gilaad G

    2015-10-14

    Recent studies have demonstrated an association between short-term elevations in air pollution and an increased risk of exacerbating gastrointestinal disease. The objective of the study was to evaluate if day-to-day increases in air pollution concentrations were positively associated with upper gastrointestinal bleeding (UGIB) secondary to peptic ulcer disease (PUD). A time-stratified case-crossover study design was used. Adults presenting to hospitals with their first UGIB secondary to PUD from 2004-2010 were identified using administrative databases from Calgary (n = 1374; discovery cohort) and Edmonton (n = 1159; replication cohort). Daily concentrations of ozone, nitrogen dioxide, sulfur dioxide, carbon monoxide, and particulate matter (PM10 and PM2.5) were estimated in these two cities. Conditional logistic regression models were employed, adjusting for temperature and humidity. Odds ratios (OR) with 95 % confidence intervals (CI) were expressed relative to an interquartile range increase in the concentration of each pollutant. No statistically significant associations were observed for any of the individual pollutants based on same-day, or 1-day lag effects within the Calgary discovery cohort. When the air pollution exposures were assessed as 3-, 5-, and 7-day averages, some pollutants were inversely associated with UGIB in the discovery cohort; for example, 5-day averages of nitrogen dioxide (OR = 0.68; 95 % CI: 0.53-0.88), and particulate matter <2.5 μm (OR = 0.75; 95 % CI: 0.61-0.90). However, these findings could not be reproduced in the replication cohort. Our findings suggest that short-term elevations in the level of ambient air pollutants does not increase the incidence of UGIB secondary to PUD.

  19. Antithrombotic properties of rafigrelide: a phase 1, open-label, non-randomised, single-sequence, crossover study.

    Science.gov (United States)

    Balasubramaniam, K; Viswanathan, G; Dragone, J; Grose-Hodge, R; Martin, P; Troy, S; Preston, P; Zaman, A G

    2014-07-03

    Platelets play a central role in atherothrombotic events. We investigated the effect of a novel platelet-lowering agent, rafigrelide, on thrombus formation and characteristics. In this phase 1, open-label, non-randomised, single-sequence, crossover study, healthy male volunteers received rafigrelide for 14 days (Period 1). Following a ≥6-week washout period, they then received rafigrelide + acetylsalicylic acid (ASA) for 14 days (Period 2). Thrombus formation was assessed ex vivo using the Badimon perfusion chamber, and thrombus characteristics were assessed using thromboelastography. A total of 15 volunteers were enrolled in the study and were assigned to Panel A or Panel B, which had different schedules of assessments. In Panel A, after treatment with rafigrelide alone (Period 1), mean (± standard deviation) platelet count was reduced from 283 (± 17) × 10⁹/l at Day 1, to 125 (± 47) × 10⁹/l at Day 14 (n=6) and thrombus area reduced under high and low shear conditions. Reductions in thrombus area under high shear conditions correlated with reductions in platelet count (r²=0.11, p=0.022; n=12). Rafigrelide treatment prolonged clot formation time and reduced clot strength. The addition of ASA to rafigrelide (Period 2) had no additional effect on platelet count or thrombus area under high or low shear conditions. Similar results were seen in Panel B for all parameters. The most common adverse events (≥3 participants per period) were thrombocytopenia and headache. While confirming the platelet-lowering effects of rafigrelide, this early phase study also indicates that rafigrelide has antithrombotic properties under both high and low shear conditions.

  20. 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.

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

    NARCIS (Netherlands)

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

    2002-01-01

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

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

    DEFF Research Database (Denmark)

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

    1999-01-01

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

  3. 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...

  4. Who can benefit from virtual reality to reduce experimental pain? A crossover study in healthy subjects.

    Science.gov (United States)

    Demeter, N; Josman, N; Eisenberg, E; Pud, D

    2015-11-01

    The present study aimed to identify predicting factors affecting experimental pain stimuli reduction by using 'EyeToy', which is an Immersive Virtual Reality System (IVRS). Sixty-two healthy subjects (31 M, 31 F) underwent a battery of pain tests to determine each participant's baseline sensitivity to nociceptive. The battery included thermal pain tests (hot and cold) as well as a paradigm to induce conditioned pain modulation (CPM). Later on, each subject participated in two study conditions in random order: (1) An exposure to tonic heat stimulation (46.5 °C/135 s) to the ankle while participating in VR environment which included an activity requiring limb movements; (2) Same heat stimulation with no exposure to VR. Six pain measures were taken during each study condition (baseline, test 1-5). An interaction of time × treatment was found (RM ANOVA, F(5, 305)  = 24.33, p manipulation for pain reduction in individuals with efficient CPM and in women. These findings constitute a promising platform for future research and hold potential for the improvement and facilitation of clinical treatment. © 2015 European Pain Federation - EFIC®

  5. The satiating properties of pork are not affected by cooking methods, sousvide holding time or mincing in healthy men - a randomized cross-over meal test study

    DEFF Research Database (Denmark)

    Kehlet, Ursula; Mitra, Bhaskar; Ruiz Carrascal, Jorge

    2017-01-01

    ) on appetite regulation and in vitro protein digestibility. In a cross-over study, 37 healthy men consumed four meals containing pork: LTLT-cooked roast, 58 °C, 72 min; LTLT-cooked roast, 58 °C, 17 h; and, oven-cooked roast, 160 °C to a core temperature of 58 °C and LTLT-cooked minced patties, 58 °C, 17 h. Ad...

  6. An association between initiation of selective serotonin reuptake inhibitors and suicide - a nationwide register-based case-crossover study.

    Directory of Open Access Journals (Sweden)

    Charlotte Björkenstam

    Full Text Available BACKGROUND: Treatment with selective serotonin reuptake inhibitors (SSRI is one of the most common treatments for depression. It is however not clear whether or not there is an increased short-term suicide risk during initiation with SSRI. METHODS: A register-based nationwide case-crossover study including 5,866 suicides, 1,698 women and 4,168 men, from the Death Register 2007-2010 in Sweden. SSRI initiation was defined as a dispensed prescription of SSRI within 28 days prior to the date of suicide with no previous dispensed prescription of SSRI within 4 months prior that prescription. The control period took place one year earlier. Odds ratio (OR was estimated using conditional logistic regression. RESULT: During the 28 day period prior to suicide 48 women and 138 men were exposed to SSRI initiation (while not being exposed in the control period and 22 women and 43 men were exposed in the control period (while not being exposed in the case period. The OR for suicide after initiation with SSRI was 2.7 (95% CI: 1.6-44 for women, and 4.3 (95% CI: 3.0-6.1 for men. The highest OR was found 8-11 days after initiation with SSRI 9.7 (95% CI: 3.0-31.7 for women and men combined. CONCLUSION: The main limitation in this study is confounding by indication, but the descriptive question is however not confounded by indication. Together with plausible biological mechanisms and previous clinical and epidemiological observations our findings, linking initiation of SSRI to increased short-term suicide risk, deserve further attention specifically in the clinical setting.

  7. Lubiprostone improves visualization of small bowel for capsule endoscopy: a double-blind, placebo-controlled 2-way crossover study.

    Science.gov (United States)

    Matsuura, Mizue; Inamori, Masahiko; Inou, Yumi; Kanoshima, Kenji; Higurashi, Takuma; Ohkubo, Hidenori; Iida, Hiroshi; Endo, Hiroki; Nonaka, Takashi; Kusakabe, Akihiko; Maeda, Shin; Nakajima, Atsushi

    2017-06-01

     Lubiprostone has been reported to be an anti-constipation drug. The aim of the study was to investigate the usefulness of lubiprostone both for bowel preparation and as a propulsive agent in small bowel endoscopy.  This was a double-blind, placebo-controlled, 2-way crossover study of subjects who volunteered to undergo capsule endoscopy (CE). A total of 20 subjects (16 male and 4 female volunteers) were randomly assigned to receive a 24-μg tablet of lubiprostone 120 minutes prior to capsule ingestion for CE (L regimen), or a placebo tablet 120 minutes prior to capsule ingestion for CE (P regimen). Main outcome was gastric transit time (GTT) and small-bowel transit time (SBTT). Secondary outcome was adequacy of small-bowel cleansing and the fluid score in the small bowel. The quality of the capsule endoscopic images and fluid in the small bowel were assessed on 5-point scale.  The capsule passed into the small bowel in all cases. Median GTT was 57.3 (3 - 221) minutes for the P regimen and 61.3 (10 - 218) minutes for the L regimen ( P  = 0.836). Median SBTT was 245.0 (164 - 353) minutes for the P regimen and 228.05 (116 - 502) minutes for the L regimen ( P  = 0.501). The image quality score in the small bowel was 3.05 ± 1.08 for the P regimen and 3.80 ± 0.49 for the L regimen ( P  lubiprostone prior to CE significantly improved visualization of the small bowel during CE as a result of inducing fluid secretion into the small bowel.

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

    Science.gov (United States)

    2012-01-01

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

  9. Gaseous air pollution and emergency hospital visits for hypertension in Beijing, China: a time-stratified case-crossover study

    Science.gov (United States)

    2010-01-01

    Background A number of epidemiological studies have been conducted to research the adverse effects of air pollution on mortality and morbidity. Hypertension is the most important risk factor for cardiovascular mortality. However, few previous studies have examined the relationship between gaseous air pollution and morbidity for hypertension. Methods Daily data on emergency hospital visits (EHVs) for hypertension were collected from the Peking University Third Hospital. Daily data on gaseous air pollutants (sulfur dioxide (SO2) and nitrogen dioxide (NO2)) and particulate matter less than 10 μm in aerodynamic diameter (PM10) were collected from the Beijing Municipal Environmental Monitoring Center. A time-stratified case-crossover design was conducted to evaluate the relationship between urban gaseous air pollution and EHVs for hypertension. Temperature and relative humidity were controlled for. Results In the single air pollutant models, a 10 μg/m3 increase in SO2 and NO2 were significantly associated with EHVs for hypertension. The odds ratios (ORs) were 1.037 (95% confidence interval (CI): 1.004-1.071) for SO2 at lag 0 day, and 1.101 (95% CI: 1.038-1.168) for NO2 at lag 3 day. After controlling for PM10, the ORs associated with SO2 and NO2 were 1.025 (95% CI: 0.987-1.065) and 1.114 (95% CI: 1.037-1.195), respectively. Conclusion Elevated urban gaseous air pollution was associated with increased EHVs for hypertension in Beijing, China. PMID:20920362

  10. Gaseous air pollution and emergency hospital visits for hypertension in Beijing, China: a time-stratified case-crossover study

    Directory of Open Access Journals (Sweden)

    Zhang Yanshen

    2010-10-01

    Full Text Available Abstract Background A number of epidemiological studies have been conducted to research the adverse effects of air pollution on mortality and morbidity. Hypertension is the most important risk factor for cardiovascular mortality. However, few previous studies have examined the relationship between gaseous air pollution and morbidity for hypertension. Methods Daily data on emergency hospital visits (EHVs for hypertension were collected from the Peking University Third Hospital. Daily data on gaseous air pollutants (sulfur dioxide (SO2 and nitrogen dioxide (NO2 and particulate matter less than 10 μm in aerodynamic diameter (PM10 were collected from the Beijing Municipal Environmental Monitoring Center. A time-stratified case-crossover design was conducted to evaluate the relationship between urban gaseous air pollution and EHVs for hypertension. Temperature and relative humidity were controlled for. Results In the single air pollutant models, a 10 μg/m3 increase in SO2 and NO2 were significantly associated with EHVs for hypertension. The odds ratios (ORs were 1.037 (95% confidence interval (CI: 1.004-1.071 for SO2 at lag 0 day, and 1.101 (95% CI: 1.038-1.168 for NO2 at lag 3 day. After controlling for PM10, the ORs associated with SO2 and NO2 were 1.025 (95% CI: 0.987-1.065 and 1.114 (95% CI: 1.037-1.195, respectively. Conclusion Elevated urban gaseous air pollution was associated with increased EHVs for hypertension in Beijing, China.

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

    Science.gov (United States)

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

    2012-11-01

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

  12. Reduction of nasal volume after allergen-induced rhinitis in patients treated with rupatadine: a randomized, cross-over, double-blind, placebo-controlled study.

    Science.gov (United States)

    Valero, A; Serrano, C; Bartrá, J; Izquierdo, I; Muñoz-Cano, R; Mullol, J; Picado, C

    2009-01-01

    To measure the reduction in nasal obstruction using acoustic rhinometry in patients with allergic rhinitis treated with rupatadine. We performed a randomized, double-blind, cross-over, placebo-controlled clinical trial in asymptomatic patients with allergic rhinitis. Patients received rupatadine 10 mg or placebo once daily for 3 days, in 2 subsequent periods separated by a washout interval of 14 days. We performed a nasal allergen challenge during each period, and measured nasal volume using acoustic rhinometry and nasal nitric oxide (nNO) at baseline, and at 2 hours and 24 hours after the challenge. We also evaluated nasal symptoms (rhinorrhea, itching, obstruction, and sneezing), as well as total symptom score (T4SS) at the same time points as for the primary objective. The study population comprised 30 outpatients with a mean (SD) age of 28 (10) years. Nasal airway blockage was significantly lower in the rupatadine group than in the placebo group (47%, P rupatadine-treated patients remained unaltered, unlike in the placebo-treated group, where levels decreased at 2 hours. After treatment with rupatadine, patients showed a lower decrease in the mean total symptoms score at 2 hours (3.6 [2.6]) compared with placebo (3.9 [2.9]), although these differences did not achieve statistical significance. Overall, rupatadine was well tolerated and no serious or unexpected adverse events were observed. Rupatadine 10 mg can reduce nasal obstruction assessed by objective measures and is well tolerated in patients with allergic rhinitis.

  13. Travel abroad increases sexual health risk-taking among Swedish youth: a population-based study using a case-crossover strategy.

    Science.gov (United States)

    Sundbeck, Mats; Agardh, Anette; Östergren, Per-Olof

    2017-01-01

    The fact that youth take sexual risks when they are abroad have been shown in previous studies. However, it is not known if they increased their sexual risk-taking when travelling abroad, compared to the stay in their homeland. To assess whether Swedish youth increased their individual sexual risk behaviour, defined as having a casual sex partner, when travelling abroad and to examine possible factors that may be associated with increased risk-taking abroad. In 2013, a population-based sample of 2189 Swedes, 18-29 years, was assessed by a questionnaire (45% response rate). Sexuality, duration of travel, parents' country of origin, mental health, heavy episodic drinking (HED), use of illicit drugs, and socio-demographic background were assessed. Increased risk of casual sex in relation to time spent abroad vs. time spent in Sweden was analysed by a variant of case-crossover design. Factors that could be associated with increased risk of casual sex in Sweden and abroad, separately, were analysed by logistic regression.

  14. Efficacy of a Nasal Spray from Citrus limon and Cydonia oblonga for the Treatment of Hay Fever Symptoms-A Randomized, Placebo Controlled Cross-Over Study.

    Science.gov (United States)

    Hoffmann, A; Klein, S D; Gründemann, C; Garcia-Käufer, M; Wolf, U; Huber, R

    2016-09-01

    Nasal spray from lemon and quince (LQNS) is used to treat hay fever symptoms and has been shown to inhibit histamine release from mast cells in vitro. Forty-three patients with grass pollen allergy (GPA) were randomized to be treated either with placebo or LQNS for one week, respectively, in a cross-over study. At baseline and after the respective treatments patients were provoked with grass pollen allergen. Outcome parameters were nasal flow measured with rhinomanometry (primary), a nasal symptom score, histamine in the nasal mucus and tolerability. In the per protocol population absolute inspiratory nasal flow 10 and 20 min after provocation was higher with LQNS compared to placebo (-37 ± 87 mL/s; p = 0.027 and -44 ± 85 mL/s; p = 0.022). The nasal symptom score showed a trend (3.3 ± 1.8 in the placebo and 2.8 ± 1.5 in the LQNS group; p = 0.070) in favor of LQNS; the histamine concentration was not significantly different between the groups. Tolerability of both, LQNS and placebo, was rated as very good. LQNS seems to have an anti-allergic effect in patients with GPA. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  15. Comparison of minimalist footwear strategies for simulating barefoot running: a randomized crossover study.

    Directory of Open Access Journals (Sweden)

    Karsten Hollander

    Full Text Available Possible benefits of barefoot running have been widely discussed in recent years. Uncertainty exists about which footwear strategy adequately simulates barefoot running kinematics. The objective of this study was to investigate the effects of athletic footwear with different minimalist strategies on running kinematics. Thirty-five distance runners (22 males, 13 females, 27.9 ± 6.2 years, 179.2 ± 8.4 cm, 73.4 ± 12.1 kg, 24.9 ± 10.9 km x week(-1 performed a treadmill protocol at three running velocities (2.22, 2.78 and 3.33 m x s(-1 using four footwear conditions: barefoot, uncushioned minimalist shoes, cushioned minimalist shoes, and standard running shoes. 3D kinematic analysis was performed to determine ankle and knee angles at initial foot-ground contact, rate of rear-foot strikes, stride frequency and step length. Ankle angle at foot strike, step length and stride frequency were significantly influenced by footwear conditions (p<0.001 at all running velocities. Posthoc pairwise comparisons showed significant differences (p<0.001 between running barefoot and all shod situations as well as between the uncushioned minimalistic shoe and both cushioned shoe conditions. The rate of rear-foot strikes was lowest during barefoot running (58.6% at 3.33 m x s(-1, followed by running with uncushioned minimalist shoes (62.9%, cushioned minimalist (88.6% and standard shoes (94.3%. Aside from showing the influence of shod conditions on running kinematics, this study helps to elucidate differences between footwear marked as minimalist shoes and their ability to mimic barefoot running adequately. These findings have implications on the use of footwear applied in future research debating the topic of barefoot or minimalist shoe running.

  16. Comparison of minimalist footwear strategies for simulating barefoot running: a randomized crossover study.

    Science.gov (United States)

    Hollander, Karsten; Argubi-Wollesen, Andreas; Reer, Rüdiger; Zech, Astrid

    2015-01-01

    Possible benefits of barefoot running have been widely discussed in recent years. Uncertainty exists about which footwear strategy adequately simulates barefoot running kinematics. The objective of this study was to investigate the effects of athletic footwear with different minimalist strategies on running kinematics. Thirty-five distance runners (22 males, 13 females, 27.9 ± 6.2 years, 179.2 ± 8.4 cm, 73.4 ± 12.1 kg, 24.9 ± 10.9 km x week(-1)) performed a treadmill protocol at three running velocities (2.22, 2.78 and 3.33 m x s(-1)) using four footwear conditions: barefoot, uncushioned minimalist shoes, cushioned minimalist shoes, and standard running shoes. 3D kinematic analysis was performed to determine ankle and knee angles at initial foot-ground contact, rate of rear-foot strikes, stride frequency and step length. Ankle angle at foot strike, step length and stride frequency were significantly influenced by footwear conditions (p<0.001) at all running velocities. Posthoc pairwise comparisons showed significant differences (p<0.001) between running barefoot and all shod situations as well as between the uncushioned minimalistic shoe and both cushioned shoe conditions. The rate of rear-foot strikes was lowest during barefoot running (58.6% at 3.33 m x s(-1)), followed by running with uncushioned minimalist shoes (62.9%), cushioned minimalist (88.6%) and standard shoes (94.3%). Aside from showing the influence of shod conditions on running kinematics, this study helps to elucidate differences between footwear marked as minimalist shoes and their ability to mimic barefoot running adequately. These findings have implications on the use of footwear applied in future research debating the topic of barefoot or minimalist shoe running.

  17. Effects of Ayurvedic Oil-Dripping Treatment with Sesame Oil vs. with Warm Water on Sleep: A Randomized Single-Blinded Crossover Pilot Study.

    Science.gov (United States)

    Tokinobu, Akiko; Yorifuji, Takashi; Tsuda, Toshihide; Doi, Hiroyuki

    2016-01-01

    Ayurvedic oil-dripping treatment (Shirodhara) is often used for treating sleep problems. However, few properly designed studies have been conducted, and the quantitative effect of Shirodhara is unclear. This study sought to quantitatively evaluate the effect of sesame oil Shirodhara (SOS) against warm water Shirodhara (WWS) on improving sleep quality and quality of life (QOL) among persons reporting sleep problems. This randomized, single-blinded, crossover study recruited 20 participants. Each participant received seven 30-minute sessions within 2 weeks with either liquid. The washout period was at least 2 months. The Shirodhara procedure was conducted by a robotic oil-drip system. The outcomes were assessed by the Pittsburgh Sleep Quality Index (PSQI) for sleep quality, Epworth Sleepiness Scale (ESS) for daytime sleepiness, World Health Organization Quality of Life 26 (WHO-QOL26) for QOL, and a sleep monitor instrument for objective sleep measures. Changes between baseline and follow-up periods were compared between the two types of Shirodhara. Analysis was performed with generalized estimating equations. Of 20 participants, 15 completed the study. SOS improved sleep quality, as measured by PSQI. The SOS score was 1.83 points lower (95% confidence interval [CI], -3.37 to -0.30) at 2-week follow-up and 1.73 points lower (95% CI, -3.84 to 0.38) than WWS at 6-week follow-up. Although marginally significant, SOS also improved QOL by 0.22 points at 2-week follow-up and 0.19 points at 6-week follow-up compared with WWS. After SOS, no beneficial effects were observed on daytime sleepiness or objective sleep measures. This pilot study demonstrated that SOS may be a safe potential treatment to improve sleep quality and QOL in persons with sleep problems.

  18. Cytokine Changes following Acute Ethanol Intoxication in Healthy Men: A Crossover Study.

    Science.gov (United States)

    Neupane, Sudan Prasad; Skulberg, Andreas; Skulberg, Knut Ragnvald; Aass, Hans Christian D; Bramness, Jørgen G

    2016-01-01

    Alcohol is a known modulator of the innate immune system. Owing to the absence of human studies, alcohol's effect on circulating cytokine profile remains unclear. We investigated the effect of acute high dose alcohol consumption on systemic cytokine release. After an overnight fasting, alcohol-experienced healthy male volunteers (N = 20) aged 25-45 years were given oral ethanol in the form of vodka (4.28 mL/kg) which they drank over a period of 30 minutes reaching peak blood alcohol concentration of 0.12% (SD 0.028). Blood samples were obtained prior to alcohol intake as well as 2, 7, and 12 hours thereafter. Serum levels of the inflammatory cytokines IL-1β, IL-1Ra, IL-6, IL-10, IL-17, IFN-γ, MCP-1, and TNF-α were determined by the multibead-based assay. Baseline cytokine levels were not related to BMI, hepatic parameters, electrolytes, glucose, or morning cortisol levels. Within 2 hours of alcohol intake, levels of IL-1Ra were elevated and remained so throughout the assessment period (p for trend = 0.015). In contrast, the levels of the chemokine MCP-1 dropped acutely followed by steadily increasing levels during the observation period (p < 0.001). The impact of sustained elevated levels of MCP-1 even after the clearance of blood alcohol content deserves attention.

  19. Cytokine Changes following Acute Ethanol Intoxication in Healthy Men: A Crossover Study

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    Sudan Prasad Neupane

    2016-01-01

    Full Text Available Alcohol is a known modulator of the innate immune system. Owing to the absence of human studies, alcohol’s effect on circulating cytokine profile remains unclear. We investigated the effect of acute high dose alcohol consumption on systemic cytokine release. After an overnight fasting, alcohol-experienced healthy male volunteers (N=20 aged 25–45 years were given oral ethanol in the form of vodka (4.28 mL/kg which they drank over a period of 30 minutes reaching peak blood alcohol concentration of 0.12% (SD 0.028. Blood samples were obtained prior to alcohol intake as well as 2, 7, and 12 hours thereafter. Serum levels of the inflammatory cytokines IL-1β, IL-1Ra, IL-6, IL-10, IL-17, IFN-γ, MCP-1, and TNF-α were determined by the multibead-based assay. Baseline cytokine levels were not related to BMI, hepatic parameters, electrolytes, glucose, or morning cortisol levels. Within 2 hours of alcohol intake, levels of IL-1Ra were elevated and remained so throughout the assessment period (p for trend = 0.015. In contrast, the levels of the chemokine MCP-1 dropped acutely followed by steadily increasing levels during the observation period (p<0.001. The impact of sustained elevated levels of MCP-1 even after the clearance of blood alcohol content deserves attention.

  20. 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.

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

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    Goldstein Brahm

    2012-01-01

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

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

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    Dennis Morrison

    2007-12-01

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

  3. A High Protein Diet Has No Harmful Effects: A One-Year Crossover Study in Resistance-Trained Males.

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    Antonio, Jose; Ellerbroek, Anya; Silver, Tobin; Vargas, Leonel; Tamayo, Armando; Buehn, Richard; Peacock, Corey A

    2016-01-01

    The purpose of this investigation was to determine the effects of a high protein diet over a one-year period. Fourteen healthy resistance-trained men completed the study (mean ± SD; age 26.3 ± 3.9 yr; height 178.5 ± 8.4 cm; and average years of training 8.9 ± 3.4 yr). In a randomized crossover design, subjects consumed their habitual or normal diet for 2 months and 4 months and alternated that with a higher protein diet (>3 g/kg/d) for 2 months and 4 months. Thus, on average, each subject was on their normal diet for 6 months and a higher protein diet for 6 months. Body composition was assessed via the Bod Pod®. Each subject provided approximately 100-168 daily dietary self-reports. During the subjects' normal eating phase, they consumed (mean ± SD) 29.94 ± 5.65 kcals/kg/day and 2.51 ± 0.69 g/kg/day of protein. This significantly increased (p < 0.05) during the high protein phase to 34.37 ± 5.88 kcals/kg/day and 3.32 ± 0.87 g/kg/day of protein. Our investigation discovered that, in resistance-trained men that consumed a high protein diet (~2.51-3.32 g/kg/d) for one year, there were no harmful effects on measures of blood lipids as well as liver and kidney function. In addition, despite the total increase in energy intake during the high protein phase, subjects did not experience an increase in fat mass.

  4. The effect of a standardised source of divided attention in airway management: A randomised, crossover, interventional manikin study.

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    Prottengeier, Johannes; Petzoldt, Marlen; Jess, Nikola; Moritz, Andreas; Gall, Christine; Schmidt, Joachim; Breuer, Georg

    2016-03-01

    Dual-tasking, the need to divide attention between concurrent tasks, causes a severe increase in workload in emergency situations and yet there is no standardised training simulation scenario for this key difficulty. We introduced and validated a quantifiable source of divided attention and investigated its effects on performance and workload in airway management. A randomised, crossover, interventional simulation study. Center for Training and Simulation, Department of Anaesthesiology, Erlangen University Hospital, Germany. One hundred and fifty volunteer medical students, paramedics and anaesthesiologists of all levels of training. Participants secured the airway of a manikin using a supraglottic airway, conventional endotracheal intubation and video-assisted endotracheal intubation with and without the Paced Auditory Serial Addition Test (PASAT), which served as a quantifiable source of divided attention. Primary endpoint was the time for the completion of each airway task. Secondary endpoints were the number of procedural mistakes made and the perceived workload as measured by the National Aeronautics and Space Administration's task load index (NASA-TLX). This is a six-dimensional questionnaire, which assesses the perception of demands, performance and frustration with respect to a task on a scale of 0 to 100. All 150 participants completed the tests. Volunteers perceived our test to be challenging (99%) and the experience of stress and distraction true to an emergency situation (80%), but still fair (98%) and entertaining (95%). The negative effects of divided attention were reproducible in participants of all levels of expertise. Time consumption and perceived workload increased and almost half the participants make procedural mistakes under divided attention. The supraglottic airway technique was least affected by divided attention. The scenario was effective for simulation training involving divided attention in acute care medicine. The significant effects

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

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

    2018-02-01

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

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

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

    2017-07-01

    This single group, randomized, cross-over study explored whether manual therapy alters motor tone of deep thoracic back muscles by examining resting electromyographic activity (EMG) after 2 types of manual therapy and a sham control intervention. Twenty-two participants with thoracic spinal pain (15 females, 7 males, mean age 28.1 ± 6.4 years) had dual fine-wire, intramuscular electrodes inserted into deep transversospinalis muscles at a thoracic level where tissues appeared abnormal to palpation (AbP) and at 2 sites above and below normal and non-tender to palpation (NT). A surface electrode was on the contralateral paraspinal mass at the level of AbP. EMG signals were recorded for resting prone, two 3-s free neck extension efforts, two 3-s resisted maximal voluntary isometric contractions (MVIC), and resting prone before the intervention. Randomized spinal manipulation, counterstrain, or sham manipulation was delivered and EMG re-measured. Participants returned 1 and 2 weeks later for the remaining 2 treatments. Reductions in resting EMG followed counterstrain in AbP (median decrease 3.3%, P = 0.01) and NT sites (median decrease 1.0%, P = 0.05) and for the surface electrode site (median decrease 2.0%, P = 0.009). Reduction in EMG following counterstrain during free neck extension was found for the surface electrode site (median decrease 2.7%, P muscle activity during prone resting and free neck extension conditions. The clinical relevance of these changes is unclear. Copyright © 2017 Elsevier Ltd. All rights reserved.

  7. A High Protein Diet Has No Harmful Effects: A One-Year Crossover Study in Resistance-Trained Males

    Directory of Open Access Journals (Sweden)

    Jose Antonio

    2016-01-01

    Full Text Available The purpose of this investigation was to determine the effects of a high protein diet over a one-year period. Fourteen healthy resistance-trained men completed the study (mean ± SD; age 26.3±3.9 yr; height 178.5±8.4 cm; and average years of training 8.9±3.4 yr. In a randomized crossover design, subjects consumed their habitual or normal diet for 2 months and 4 months and alternated that with a higher protein diet (>3 g/kg/d for 2 months and 4 months. Thus, on average, each subject was on their normal diet for 6 months and a higher protein diet for 6 months. Body composition was assessed via the Bod Pod®. Each subject provided approximately 100–168 daily dietary self-reports. During the subjects’ normal eating phase, they consumed (mean ± SD 29.94±5.65 kcals/kg/day and 2.51±0.69 g/kg/day of protein. This significantly increased (p<0.05 during the high protein phase to 34.37±5.88 kcals/kg/day and 3.32±0.87 g/kg/day of protein. Our investigation discovered that, in resistance-trained men that consumed a high protein diet (~2.51–3.32 g/kg/d for one year, there were no harmful effects on measures of blood lipids as well as liver and kidney function. In addition, despite the total increase in energy intake during the high protein phase, subjects did not experience an increase in fat mass.

  8. Acupuncture compared to oral antihistamine for type I hypersensitivity itch and skin response in adults with atopic dermatitis – a patient and examiner blinded, randomized, placebo-controlled, crossover trial

    Science.gov (United States)

    Pfab, Florian; Kirchner, Marie-Therese; Huss-Marp, Johannes; Schuster, Tibor; Schalock, Peter C.; Fuqin, Jiang; Athanasiadis, Georgios I.; Behrendt, Heidrun; Ring, Johannes; Darsow, Ulf; Napadow, Vitaly

    2012-01-01

    Background Itch is the major symptom of atopic dermatitis (AD). Acupuncture has been shown to exhibit a significant effect on experimental itch in AD. Our study evaluated acupuncture and anti-histamine itch therapy (cetirizine) on type-I-hypersensitivity itch and skin reaction in AD using a patient and examiner blinded, randomized, placebo-controlled, crossover trial. Methods Allergen–induced itch was evaluated in 20 AD patients after several interventions in separate sessions: preventive (preceding) and abortive (concurrent) verum acupuncture (VAp and VAa), cetirizine (10mg, VC), corresponding placebo interventions (preventive, PAp, and abortive, PAa, placebo acupuncture; placebo cetirizine pill, PC), and a no-intervention control (NI). Itch was induced on the forearm and temperature modulated over 20 minutes, using our validated model. Outcome parameters included itch intensity, wheal and flare size, and the D2 Attention test. Results Mean itch intensity (SE: 0.31 each) was significantly lower following VAa (31.9) compared to all other groups (PAa: 36.5; VC: 36.8; VAp: 37.6; PC: 39.8; PAp: 39.9; NI: 45.7, p0.1), though both therapies were significantly superior to their respective placebo interventions (p<0.05). Flare size following VAp was significantly smaller (p=0.034) than PAp. D2 attention test score was significantly lower following VC compared to all other groups (p<0.001). Conclusions Both VA and cetirizine significantly reduced type-I-hypersensitivity itch in AD patients, compared to both placebo and NI. Timing of acupuncture application was important, as VAa had the most significant effect on itch, potentially due to counter-irritation and/or distraction. Itch reduction following cetirizine coincided with reduced attention. PMID:22313287

  9. Intragastric acidity during administration of generic omeprazole or esomeprazole - a randomised, two-way crossover study including CYP2C19 genotyping.

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    Miehlke, S; Löbe, S; Madisch, A; Kuhlisch, E; Laass, M; Grossmann, D; Knoth, H; Morgner, A; Labenz, J

    2011-02-01

    Generic omeprazole has been approved in many countries for the treatment of acid-related gastrointestinal disorders. However, clinical studies comparing generic to original proton pump inhibitors are limited. To compare the effect of generic omeprazole 20 mg/day with esomeprazole 20 mg/day on intragastric acidity and to investigate the influence of the CYP2C19 metabolizer status. In this randomised, single-blinded, two-way crossover study, 24 healthy Helicobacter pylori-negative subjects, received generic omeprazole (Omep; Hexal AG, Holzkirchen, Germany) 20 mg once daily or esomeprazole 20 mg once daily for five consecutive days. Twenty-four-hour intragastric pH was recorded on day 5 of each treatment. CYP2C19 status was determined by polymerase chain reaction-restriction fragment length polymorphism. Over all, there were no statistically significant differences between generic omeprazole and esomeprazole with respect to median intragastric pH (3.5 and 3.9, P = 0.07), the total hours with intragastric pH >4 (10.4 and 11.3, P = 0.29), and during upright (9.6 and 9.1, P = 0.77) or supine (2.2 and 2.2, P = 0.94) position. However, in CYP2C19 rapid metabolizers, esomeprazole was superior to omeprazole, with the percentage of time with intragastric pH >3.0 and pH >3.5 being higher with esomeprazole than with generic omeprazole [Δ = 9% (P = 0.026) and Δ = 8% (P = 0.046), respectively]. Overall, generic omeprazole 20 mg appears to provide a similar intragastric acid control when compared with esomeprazole 20 mg. However, esomeprazole might be advantageous in subjects with a rapid CYP2C19 metabolizer status. © 2010 Blackwell Publishing Ltd.

  10. Safety and efficacy of a fully closed-loop control ventilation (IntelliVent-ASV®) in sedated ICU patients with acute respiratory failure: a prospective randomized crossover study.

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    Arnal, Jean-Michel; Wysocki, Marc; Novotni, Dominik; Demory, Didier; Lopez, Ricardo; Donati, Stéphane; Granier, Isabelle; Corno, Gaëlle; Durand-Gasselin, Jacques

    2012-05-01

    IntelliVent-ASV(®) is a development of adaptive support ventilation (ASV) that automatically adjusts ventilation and oxygenation parameters. This study assessed the safety and efficacy of IntelliVent-ASV(®) in sedated intensive care unit (ICU) patients with acute respiratory failure. This prospective randomized crossover comparative study was conducted in a 12-bed ICU in a general hospital. Two periods of 2 h of ventilation in randomly applied ASV or IntelliVent-ASV(®) were compared in 50 sedated, passively ventilated patients. Tidal volume (V(T)), respiratory rate (RR), inspiratory pressure (P(INSP)), SpO(2) and E(T)CO(2) were continuously monitored and recorded breath by breath. Mean values over the 2-h period were calculated. Respiratory mechanics, plateau pressure (P(PLAT)) and blood gas exchanges were measured at the end of each period. There was no safety issue requiring premature interruption of IntelliVent-ASV(®). Minute ventilation (MV) and V(T) decreased from 7.6 (6.5-9.5) to 6.8 (6.0-8.0) L/min (p mechanics, pH, PaO(2) and PaO(2)/FiO(2) ratio were not different but PaCO(2) was slightly higher during IntelliVent-ASV(®) as compared to ASV. In passive patients with acute respiratory failure, IntelliVent-ASV(®) was safe and able to ventilate patients with less pressure, volume and FiO(2) while producing the same results in terms of oxygenation.

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

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    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.

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

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    Yih-Jing Tang

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

  13. Attentional focus of feedback for improving performance of reach-to-grasp after stroke: a randomised crossover study.

    Science.gov (United States)

    Durham, K F; Sackley, C M; Wright, C C; Wing, A M; Edwards, M G; van Vliet, P

    2014-06-01

    To investigate whether feedback inducing an external focus (EF) of attention (about movement effects) was more effective for retraining reach-to-grasp after stroke compared with feedback inducing an internal focus (IF) of attention (about body movement). It was predicted that inducing an EF of attention would be more beneficial to motor performance. Crossover trial where participants were assigned at random to two feedback order groups: IF followed by EF or EF followed by IF. Research laboratory. Forty-two people with upper limb impairment after stroke. Participants performed three reaching tasks: (A) reaching to grasp a jar; (B) placing a jar forwards on to a table; and (C) placing a jar on to a shelf. Ninety-six reaches were performed in total over one training session. Kinematic measures were collected using motion analysis. Primary outcome measures were movement duration, peak velocity of the wrist, size of peak aperture and peak elbow extension. Feedback inducing an EF of attention produced shorter movement durations {first feedback order group: IF mean 2.53 seconds [standard deviation (SD) 1.85]; EF mean 2.12 seconds (SD 1.63), mean difference 0.41 seconds; 95% confidence interval -0.68 to 1.5; P=0.008}, an increased percentage time to peak deceleration (P=0.01) when performing Task B, and an increased percentage time to peak velocity (P=0.039) when performing Task A compared with feedback inducing an IF of attention. However, an order effect was present whereby performance was improved if an EF of attention was preceded by an IF of attention. Feedback inducing an EF of attention may be of some benefit for improving motor performance of reaching in people with stroke in the short term; however, these results should be interpreted with caution. Further research using a randomised design is recommended to enable effects on motor learning to be assessed. Copyright © 2013 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  14. Gaviscon Double Action Liquid (antacid & alginate) is more effective than antacid in controlling postprandial esophageal acid exposure in GERD patients; a double-blind crossover study

    Science.gov (United States)

    De Ruigh, Annemijn; Roman, Sabine; Chen, Joan; Pandolfino, John E.; Kahrilas, Peter J.

    2015-01-01

    Background Recent studies have shown that Gaviscon Double Action Liquid (a combination alginate-antacid) administered postprandially co-localizes with the acid pocket, the ‘reservoir’ for postprandial acid reflux. Aim This study compared the effectiveness of Gaviscon Double Action Liquid to an equivalent strength antacid without alginate in controlling postprandial acid reflux in GERD patients. Methods 14 GERD patients undertook two 3.5-hour high-resolution manometry/pH-impedance studies during which they ate a standardized meal. In a double-blinded randomized crossover design they then took Gaviscon or CVS brand antacid, each with ~18 mmol/l acid neutralizing capacity. The primary outcome was distal esophageal acid exposure; secondary outcomes were number of reflux events, proximal extent of reflux, nadir pH of the refluxate, mechanism of reflux, and reflux symptoms scored with a validated instrument. Results 10 patients completed the study. Gaviscon studies had significantly less distal esophageal acid exposure and greater nadir refluxate pH in the 30–150 minute postprandial period than antacid studies. There were no differences in the number of reflux events (acid or weakly acidic) or the number of proximal reflux events (15–17 cm above the LES) with either study medication. Conclusions Gaviscon Double Action Liquid was more effective than an antacid without alginate in controlling postprandial esophageal acid exposure. However, the number and spatial distribution of reflux events within the esophagus were similar. This suggests that Gaviscon main effectiveness related to its co-localization with and displacement/neutralization of the post-prandial acid pocket, rather than preventing reflux. PMID:25041141

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

    Science.gov (United States)

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

    2014-09-01

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

  16. The children and sunscreen study: a crossover trial investigating children's sunscreen application thickness and the influence of age and dispenser type.

    Science.gov (United States)

    Diaz, Abbey; Neale, Rachel E; Kimlin, Michael G; Jones, Lee; Janda, Monika

    2012-05-01

    To measure the thickness at which primary schoolchildren apply sunscreen on school day mornings and to compare it with the thickness (2.00 mg/cm(2)) at which sunscreen is tested during product development, as well as to investigate how application thickness was influenced by age of the child (school grades 1-7) and by dispenser type (500-mL pump, 125-mL squeeze bottle, or 50-mL roll-on). A crossover quasiexperimental study design comparing 3 sunscreen dispenser types. Children aged 5 to 12 years from public primary schools (grades 1-7) in Queensland, Australia. Children (n=87) and their parents randomly recruited from the enrollment lists of 7 primary schools. Each child provided up to 3 observations (n=258). Children applied sunscreen during 3 consecutive school weeks (Monday through Friday) for the first application of the day using a different dispenser each week. Thickness of sunscreen application (in milligrams per square centimeter). The dispensers were weighed before and after use to calculate the weight of sunscreen applied. This was divided by the coverage area of application (in square centimeters), which was calculated by multiplying the children's body surface area by the percentage of the body covered with sunscreen. Children applied their sunscreen at a median thickness of 0.48 mg/cm(2). Children applied significantly more sunscreen when using the pump (0.75 mg/cm(2)) and the squeeze bottle (0.57 mg/cm(2)) compared with the roll-on (0.22 mg/cm(2)) (Pdispensers seem to facilitate thicker application than others.

  17. Gaviscon Double Action Liquid (antacid & alginate) is more effective than antacid in controlling post-prandial oesophageal acid exposure in GERD patients: a double-blind crossover study.

    Science.gov (United States)

    De Ruigh, A; Roman, S; Chen, J; Pandolfino, J E; Kahrilas, P J

    2014-09-01

    Recent studies have shown that Gaviscon Double Action Liquid (a combination alginate-antacid) administered post-prandially co-localises with the acid pocket, the 'reservoir' for post-prandial acid reflux. To compare the effectiveness of Gaviscon Double Action Liquid to an equivalent strength antacid without alginate in controlling post-prandial acid reflux in GERD patients. Fourteen GERD patients undertook two 3.5-h high-resolution manometry/pH-impedance studies during which they ate a standardised meal. In a double-blinded randomised crossover design they then took Gaviscon or CVS brand antacid, each with ~18 mmol/L acid neutralising capacity. The primary outcome was distal oesophageal acid exposure; secondary outcomes were number of reflux events, proximal extent of reflux, nadir pH of the refluxate, mechanism of reflux and reflux symptoms scored with a validated instrument. Ten patients completed the study. Gaviscon studies had significantly less distal oesophageal acid exposure and greater nadir refluxate pH in the 30-150 min post-prandial period than antacid studies. There were no differences in the number of reflux events (acid or weakly acidic) or the number of proximal reflux events (15-17 cm above the LES) with either study medication. Gaviscon Double Action Liquid is more effective than an antacid without alginate in controlling post-prandial oesophageal acid exposure. However, the number and spatial distribution of reflux events within the oesophagus are similar. This suggests that Gaviscon main effectiveness relates to its co-localisation with and displacement/neutralisation of the post-prandial acid pocket, rather than preventing reflux. © 2014 John Wiley & Sons Ltd.

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

    Directory of Open Access Journals (Sweden)

    Kim YH

    2015-02-01

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

  19. Comparison of gadoxetic acid and gadopentetate dimeglumine-enhanced MRI for HCC detection: prospective crossover study at 3 T.

    Science.gov (United States)

    Besa, Cecilia; Kakite, Suguru; Cooper, Nancy; Facciuto, Marcelo; Taouli, Bachir

    2015-02-01

    Gadoxetic acid and gadopentetate dimeglumine are gadolinium-based contrast agents (GBCAs) with an established role in HCC detection and characterization. To compare gadopentetate dimeglumine and gadoxetic acid-enhanced magnetic resonance imaging (MRI) for image quality and hepatocellular carcinoma (HCC) detection/conspicuity. In this IRB approved cross-over pilot prospective study, 12 patients (all men; mean age, 56 years) with chronic liver disease at risk of HCC underwent two repeat MRI examinations using gadopentetate dimeglumine and gadoxetic acid (mean interval between studies, 5 days). Two independent observers analyzed images for image quality and HCC detection/conspicuity. Per-lesion sensitivity, positive predictive value, quantitative enhancement, and lesion-to-liver contrast ratio were calculated for both contrast agents. There was no significant difference in image quality scores between both GBCAs (P = 0.3). A total of 20 HCCs were identified with reference standard in 12 patients (mean size 2.6 cm, range, 1.0-5.0 cm). Higher sensitivity was seen for observer 1 for gadoxetic acid-set in comparison with gadopentetate dimeglumine-set (sensitivity increased from 85.7% to 92.8%), while no difference was noted for observer 2 (sensitivity of 78.5%). Lesion conspicuity was significantly higher on hepatobiliary phase (HBP) images compared to arterial phase images with both GBCAs for both observers (P gadopentetate dimeglumine-set in terms of HCC detection for one observer, with improved lesion conspicuity and liver-to-lesion contrast on HBP images.

  20. Comparison of Low-Dose Higher-Relaxivity and Standard-Dose Lower-Relaxivity Contrast Media for Delayed-Enhancement MRI: A Blinded Randomized Crossover Study.

    Science.gov (United States)

    Cheong, Benjamin Y C; Duran, Cihan; Preventza, Ourania A; Muthupillai, Raja

    2015-09-01

    The gadolinium-based MRI contrast agent gadobenate dimeglumine has nearly twice the MR relaxivity of gadopentetate dimeglumine at 1.5 T. The purpose of this study was to determine whether a lower dose (0.1 mmol/kg) of gadobenate dimeglumine can be used to obtain delayed-enhancement MR images comparable to those obtained with a standard dose (0.2 mmol/kg) of gadopentetate dimeglumine. In this blinded randomized crossover study, 20 patients with known myocardial infarction underwent two separate delayed-enhancement MRI examinations after receiving 0.1 mmol/kg gadobenate dimeglumine and 0.2 mmol/kg gadopentetate dimeglumine (random administration). The conspicuity of lesion enhancement 5, 10, and 20 minutes after contrast administration was quantified as relative enhancement ratio (RER). With either gadolinium-based contrast agent, damaged myocardium had higher signal intensity than normal remote myocardium (RER > 4) on delayed-enhancement MR images, and the blood RER declined over time after contrast administration. The blood RER was not significantly higher for gadobenate dimeglumine than for gadopentetate dimeglumine at 5 and 10 minutes. Nevertheless, there was a larger reduction in blood RER for gadobenate dimeglumine than for gadopentetate dimeglumine between 5 and 10 minutes and between 10 and 20 minutes. The volumes of enhancement were similar for gadobenate dimeglumine (13.6 ± 8.8 cm(3)) and gadopentetate dimeglumine (13.5 ± 8.9 cm(3)) (p = 0.98). The mean difference in Bland-Altman analysis for delayed-enhancement volume between the agents was 0.1 cm(3). Qualitatively and quantitatively, delayed-enhancement MR images of ischemic myocardium obtained with 0.1 mmol/kg gadobenate dimeglumine are comparable to those obtained with 0.2 mmol/kg gadopentetate dimeglumine 5, 10, and 20 minutes after contrast administration.

  1. Sex work: a comparative study.

    Science.gov (United States)

    McCarthy, Bill; Benoit, Cecilia; Jansson, Mikael

    2014-10-01

    Explanations of adult involvement in sex work typically adopt one of two approaches. One perspective highlights a variety of negative experiences in childhood and adolescence, including physical and sexual abuse, family instability, poverty, associations with "pimps" and other exploiters, homelessness, and drug use. An alternative account recognizes that some of these factors may be involved, but underscores the contribution of more immediate circumstances, such as current economic needs, human capital, and employment opportunities. Prior research offers a limited assessment of these contrasting claims: most studies have focused exclusively on people working in the sex industry and they have not assessed the independent effects of life course variables central to these two perspectives. We add to this literature with an analysis that drew on insights from life course and life-span development theories and considered the contributions of factors from childhood, adolescence, and adulthood. Our comparative approach examined predictors of employment in sex work relative to two other low-income service or care work occupations: food and beverage serving and barbering and hairstyling. Using data from a study of almost 600 workers from two cities, one in Canada and the other in the United States, we found that both immediate circumstances and negative experiences from early life are related to current sex work involvement: childhood poverty, abuse, and family instability were independently associated with adult sex work, as were limited education and employment experience, adult drug use, and marital status.

  2. Isotretinoin conundrum: a randomized, openlabel, crossover study in Mexico to evaluate the bioavailability and bioequivalence of three pharmaceutical preparations of isotretinoin in healthy participants.

    Science.gov (United States)

    Piñeyro-Garza, Everardo; Gómez-Silva, Magdalena; Gamino Peña, María Elena; Palmer, Jonathan; Berber, Arturo

    2015-10-01

    The oral retinoid agent isotretinoin (13-cis-retinoic acid) is approved for the treatment of severe recalcitrant cystic acne. For registrational renewal of Oratane® in Mexico (isotretinoin; Laboratorios Dermatologicos Darier S.A. de C.V., Mexico), it was necessary to establish bioequivalence to the reference product Roaccutan® (Isotretinoin; Roche, Mannheim, Germany). Three prior studies failed to establish the bioequivalence of Oratane to Mexican-sourced Roaccutan. However, 13 studies demonstrated the bioequivalence of Oratane to Roaccutane® from multiple sources. This study compared the bioavailability of Oratane with that of Mexicansourced Roaccutan and Australian-sourced Roaccutane. Study participants received each of the three agents in a randomized, open-label, 6-sequence, 3-way crossover study with a 2-week washout period between treatments. Pharmacokinetic analysis revealed that peak plasma concentration (Cmax) and area under the plasma concentration-time curve from time 0 (dosing) to infinite time (AUC0-∞) were lower for Roaccutan than for Roaccutane and Oratane (Cmax: 1,023.35, 1,223.08, and 1,224.25 ng/mL, respectively; AUC0-∞: 13,653.65, 15,681.35 and 15,733.55 ng/mL x h, respectively). The 90% CIs (test/reference) for the ratios of the geometric means indicated that Oratane was bioequivalent to Roaccutane but not to Roaccutan. In addition, Roaccutane (R2) was not bioequivalent to Roaccutan (R1; R1/R2 90% CIs: Cmax, 76.12 - 91.04; AUC0-t, 82.19 - 91.13; AUC0-∞, 82.94 - 91.57). Oratane and Australian-sourced Roaccutane could be considered bioequivalent, but neither formulation was found to be bioequivalent to Mexican-sourced Roaccutan.

  3. Is there an ideal way to initiate antiplatelet therapy with aspirin? A crossover study on healthy volunteers evaluating different dosing schemes with whole blood aggregometry

    Directory of Open Access Journals (Sweden)

    Overbeck Ursula

    2011-04-01

    Full Text Available Abstract Background Guidelines recommend an early initiation of aspirin treatment in patients with acute cerebral ischemia. Comparative studies on the best starting dose for initiating aspirin therapy to achieve a rapid antiplatelet effect do not exist. This study evaluated the platelet inhibitory effect in healthy volunteers by using three different aspirin loading doses to gain a model for initiating antiplatelet treatment in acute strokes patients. Methods Using whole blood aggregometry, this study with a prospective, uncontrolled, open, crossover design examined 12 healthy volunteers treated with three different aspirin loading doses: intravenous 500 mg aspirin, oral 500 mg aspirin, and a course of 200 mg aspirin on two subsequent days followed by a five-day course of 100 mg aspirin. Aspirin low response was defined as change of impedance exceeding 0 Ω after stimulation with arachidonic acid. Results Sufficient antiplatelet effectiveness was gained within 30 seconds when intravenous 500 mg aspirin was used. The mean time until antiplatelet effect was 74 minutes for 500 mg aspirin taken orally and 662 minutes (11.2 hours for the dose scheme with 200 mg aspirin with a high inter- and intraindividual variability in those two regimes. Platelet aggregation returned to the baseline range during the wash-out phase within 4 days. Conclusion Our study reveals that the antiplatelet effect differs significantly between the three different aspirin starting dosages with a high inter- and intraindividual variability of antiplatelet response in our healthy volunteers. To ensure an early platelet inhibitory effect in acute stroke patients, it could be advantageous to initiate the therapy with an intravenous loading dose of 500 mg aspirin. However, clinical outcome studies must still define the best way to initiate antiplatelet treatment with aspirin.

  4. Thermal hysteresis in spin-crossover compounds studied within the mechanoelastic model and its potential application to nanoparticles

    Science.gov (United States)

    Stoleriu, Laurentiu; Chakraborty, Pradip; Hauser, Andreas; Stancu, Alexandru; Enachescu, Cristian

    2011-10-01

    The recently developed mechanoelastic model is applied to characterize the thermal transition in spin-crossover complexes, with special attention given to the case of spin-crossover nanoparticles. In a two-dimensional system, hexagonal-shaped samples with open boundary conditions are composed of individual molecules that are linked by springs and can switch between two states, namely, the high-spin (HS) and the low-spin (LS) states. The switching of an individual molecule during the spin transition is decided by way of a Monte Carlo standard procedure, using transition probabilities depending on the temperature, the energy gap between the two states, the enthalpy difference, the degeneracy ratio, and the local pressure determined by the elongation or compression of its closest springs. The influence of external parameters, such as temperature sweeping rate and pressure, or intrinsic features of the system, such as the value of its spring constant, on the width of the thermal hysteresis, its shape, and its position are discussed. The particular case of spin-crossover nanoparticles is treated by considering them embedded into a polymer environment, which essentially affects the molecules situated at the edges and faces by decreasing their transition probabilities from HS to LS. Finally, the pressure hysteresis, obtained by varying the external pressure at constant temperature is discussed.

  5. Primary Prevention of Myocardial Infarction in Rheumatoid Arthritis Using Aspirin: A Case-crossover Study and a Propensity Score-matched Cohort Study.

    Science.gov (United States)

    Durán, Josefina; Peloquin, Christine; Zhang, Yuqing; Felson, David T

    2017-04-01

    Subjects with rheumatoid arthritis (RA) are at higher risk of developing cardiovascular disease, which is their leading cause of death. Conflicting evidence exists regarding the efficacy of aspirin (ASA) as primary prevention. We evaluated whether a protective association exists between ASA and myocardial infarction (MI) in RA subjects. In the United Kingdom, persons age ≥ 60 years receive free ASA by prescription and 75% of use is by prescription. Subjects ≥ 60 years with RA in the population-based The Health Improvement Network database constituted our study population. We excluded patients with history of MI, angina, stroke, peripheral vascular disease, or coronary artery procedures. Our main outcome was the occurrence of fatal and nonfatal MI. We performed a case-crossover study with each subject contributing a hazard period and a control period 90 days prior to the MI. In addition, to minimize confounding by indication, a propensity score (PS)-matched cohort study was performed, considering all patients with RA with an incident prescription of low-dose ASA as our exposed group. We did not find a protective effect in the case-crossover study (OR 1.83, 95% CI 0.71-4.71), with 55 subjects exposed in the hazard period and 44 in the control period. Similarly, among 1836 subjects included in the PS-matched cohort study (918 ASA users and 918 ASA non-users), we did not find a protective effect of low ASA on MI (HR 1.39, 95% CI 0.87-2.23). We did not find a protective effect of ASA on MI in patients with RA when used as primary prophylaxis.

  6. CLINICAL EFFICACY AND SAFETY OF ADEMETIONINE IN PATIENTS WITH DIABETES-ASSOCIATED OSTEOARTHRITIS: A CROSS-OVER PILOT STUDY

    Directory of Open Access Journals (Sweden)

    I. V. Shirinsky

    2015-01-01

    Full Text Available Osteoarthritis (OA is one of most common rheumatic diseases, and currently there is no effective pharmacological treatment of OA. It has been suggested that lack of effective treatment is, in part, due to the disease heterogeneity which may lead to development of several OA subtypes (phenotypes. Diabetes-associated OA is among the proposed OA phenotypes. The key mechanism involved into inflammatory and degenerative changes in OA is a decrease in DNA methylation suggested for several cell types, that was also demonstrated in type 2 diabetes mellitus. Therefore, pharmacological increase of DNA methylation may be an effective treatment strategy which may exert pleiotropic effects in diabetes-associated OA. In a randomized crossover study, we have evaluated efficacy and safety of ademetionine, a methyl group donor, in comparison with chondroitine sulfate in patients with OA associated with type 2 diabetes mellitus. The patients were randomly assigned to sequential treatment of chondroitine sulfate/ademetionine or ademetionine/chondroitine sulfate during one month, with a washout period of 2 weeks. The primary endpoint was pain measured according to visual analogue scale (VAS. Painful symptoms, as well as function and disease signs in knee, hip and hand joints were also assessed with KOOS, WOMAC, and FIHOA scales. General performance was assessed with SF–36 scale. To evaluate systemic inflammation, we measured serum IL-6, IL-18, adiponectin, and CRP using ELISA technique. Concentrations of serum cartilage destruction biomarkers (aggrecan and antibodies to collagen type II were assessed by ELISA. Serum lipid levels were measured with standard method; glycated hemoglobin was assessed with liquid chromatography. Ten patients (all women, age 61.7-74.2 year with BMI of 1.1-38.4 kg/m2 were included in the study. It has been demonstrated that ademetionine showed a statistically significant analgetic effect (decrease in VAS pain, improved

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

    Directory of Open Access Journals (Sweden)

    Jens Tank

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

  8. New, Occasional, and Frequent Use of Zolpidem or Zopiclone (Alone and in Combination) and the Risk of Injurious Road Traffic Crashes in Older Adult Drivers: A Population-Based Case-Control and Case-Crossover Study.

    Science.gov (United States)

    Nevriana, Alicia; Möller, Jette; Laflamme, Lucie; Monárrez-Espino, Joel

    2017-08-01

    Previous studies on the effect of zolpidem or zopiclone use on the risk of road traffic crashes (RTCs) have shown mixed results. Our objective was to determine the association between zolpidem or zopiclone use (as separate drugs or combined) and the occurrence of injurious RTCs among older adult drivers. This was a population-based matched case-control and case-crossover study based on secondary data linked together from Swedish national registers. Cases were drivers aged 50-80 years involved in a vehicle crash resulting in injuries between January 2006 and December 2009 for the case-control study (n = 27,096) and from February 2006 to December 2009 for the case-crossover study (n = 26,586). For the first design, four controls were matched to each case by sex, age, and residential area, and exposure was categorized into new, occasional, and frequent use of zolpidem only, zopiclone only, and combined zolpidem and zopiclone. For the case-crossover study, newly dispensed zolpidem or zopiclone users were assessed during the 28 days prior to the crash and compared with an equally long control period using a 12-week washout period. Matched adjusted odds ratios (OR) were computed using conditional logistic regression. Increased ORs for all users were observed. In the case-control study, the highest odds were seen among newly initiated zolpidem-only users involved in single-vehicle crashes (adjusted OR 2.27; 95% confidence interval [CI] 1.21-4.24), followed by frequent combined zolpidem and zopiclone users [adjusted OR 2.20; CI 1.21-4.00]. In the case-crossover, newly initiated treatment with zolpidem or zopiclone showed an increased risk that was highest in the 2 weeks after the start of the treatment (OR 2.66; 95% CI 1.04-6.81). These results provide more compelling evidence for the role of zolpidem or zopiclone in the occurrence of RTCs among older adults, not only in frequent users, but also at the beginning of treatment.

  9. Does postprandial itopride intake affect the rate of gastric emptying? A crossover study using the continuous real time 13C breath test (BreathID system).

    Science.gov (United States)

    Nonaka, Takashi; Kessoku, Takaomi; Ogawa, Yuji; Yanagisawa, Shogo; Shiba, Tadahiko; Sahaguchi, Takashi; Atsukawa, Kazuhiro; Takahashi, Hisao; Sekino, Yusuke; Iida, Hiroshi; Hosono, Kunihiro; Endo, Hiroki; Sakamoto, Yasunari; Koide, Tomoko; Takahashi, Hirokazu; Tokoro, Chikako; Abe, Yasunobu; Maeda, Shin; Nakajima, Atsushi; Inamori, Masahiko

    2011-01-01

    The aim of this study was to determine whether oral Itopride hydrochloride (itopride) intake might have any effect on the rate of gastric emptying, using a novel non-invasive technique for measuring the rate of gastric emptying, namely, the continuous real time 13C breath test (BreathID system: Exalenz Bioscience Ltd., Israel). Eight healthy male volunteers participated in this randomized, two-way crossover study. The subjects fasted overnight and were randomly assigned to receive 50mg itopride following a test meal (200 kcal per 200mL, containing 100mg 13C acetate), or the test meal alone. Under both conditions, gastric emptying was monitored for 4 hours after administration of the test meal by the 13C-acetic acid breath test performed continually using the BreathID system. Using Oridion Research Software (beta version), the time required for emptying of 50% of the labeled meal (T 1/2), the analog to the scintigraphy lag time for 10% emptying of the labeled meal (T lag), the gastric emptying coefficient (GEC), and the regression-estimated constants (beta and kappa) were calculated. The parameters measured under the two conditions were compared using the Wilcoxon's signed-rank test. No significant differences in the calculated parameters, namely, the T 1/2, T lag, GEC, beta or kappa, were observed between the two test conditions, namely, administration of a test meal+itopride and administration of the test meal alone. The present study revealed that postprandial itopride intake had no significant influence on the rate of gastric emptying. Recently, several studies have shown that itopride may be effective in the treatment of patients with functional dyspepsia. Our results suggest that the efficacy of itopride in patients with functional dyspepsia may be based on its effect of improving functions other than the rate of gastric emptying, such as the activities at neuronal sites, brain-gut correlation, visceral hypersensitivity, gastric accommodation and distension

  10. A randomised, controlled, crossover study to investigate the safety and response of 1R,2S-methoxamine hydrochloride (NRL001) on anal function in healthy volunteers.

    Science.gov (United States)

    Simpson, J A D; Bush, D; Gruss, H J; Jacobs, A; Pediconi, C; Scholefield, J H

    2014-03-01

    This study aimed to assess the dose and volume effects of suppository preparations and safety of NRL001 (one of four possible stereoisomers of methoxamine hydrochloride) on anal sphincter tone using rectal suppositories in healthy adult volunteers. This was a Phase I, single-centre, randomised, double-blind, three-way crossover study during which subjects received three single doses of 1 g rectal suppositories (containing 5 or 10 mg NRL001 or matching placebo) or 2 g rectal suppositories (containing 10 or 15 mg NRL001 or matching placebo) on three separate dosing days. The outcome measures were mean anal resting pressure (MARP) variables (monitored continuously for 20-30 min before and up to 6 h after dosing), pharmacokinetics (PK) and safety assessments. Twenty-six subjects were dosed with study medication. Two subjects were withdrawn prematurely and were not included in the main analysis. There was a dose-dependent increase in anal sphincter tone (MARP) when comparing the 5 and 10 mg doses of NRL001; however, the 15 mg dose did not have a significantly greater effect than the 10 mg dose. Suppository size (1 or 2 g) did not appear to have an effect on sphincter tone. There was no evidence against dose proportionality for the PK variables, but the mean maximum plasma concentration (Cmax ) for the 1 g suppository group was higher than for the 2 g group. Twenty-one adverse events were reported in 8 (30.8%) subjects. A dose dependent decrease in heart rate was noted; however, there were no adverse events reported that were related to this reduction in heart rate. The increase in anal sphincter tone supports the potential therapeutic use of NRL001 in treating faecal incontinence, with further studies in patients required. NRL001 was well tolerated in single doses of up to 15 mg. Colorectal Disease © 2014 The Association of Coloproctology of Great Britain and Ireland.

  11. Pharmacokinetics and bioequivalence study of three oral formulations of ambroxol 30 mg: a randomized, three-period crossover comparison in healthy volunteers.

    Science.gov (United States)

    Jiang, Bo; Chen, Jin-Liang; Lou, Hong-Gang; Yu, Ling-Yan; Shen, Hua-Hao; Ruan, Zou-Rong

    2014-10-01

    To compare the pharmacokinetic properties of two newly developed generic ambroxol formulations with a branded innovator product in healthy Chinese male volunteers. This was a single-dose, randomized, open-label, three-period crossover study in healthy volunteers aged 18 - 45 years under fasting conditions. Subjects were assigned to receive 1 of 2 test formulations or a reference tablet of ambroxol 30 mg. Each study period was separated by a 1-week washout phase. Blood samples were collected at pre-specified times. A non-compartmental method was employed to determine pharmacokinetic properties (C(max), t(max), AUC(0-tlast), AUC(0-∞)) to test for bioequivalence. The predetermined regulatory range of 90% CI for bioequivalence was 80 - 125%. 24 subjects were enrolled in and completed the study. The geometric mean C(max) values for the test tablet, test capsule, and reference product were 82.73, 85.36, 84.56 ng/mL, and their geometric mean AUC(0-tlast) (AUC(0-∞)) were 660.87 (753.49), 678.98 (756.79), and 639.41 (712.14) ng x h/mL, respectively. For test tablet vs. reference, the 90% CIs of the least squares mean test/reference ratios of C(max), AUC(0-tlast), and AUC(0-∞) were 91.2% to 104.9%, 96.5% to 110.7%, and 98.8% to 113.4%, respectively. For test capsule, the corresponding values were 94.1% to 108.3%, 99.2% to 113.7%, and 99.2% to 113.9%, respectively. No adverse events occurred during the study. The ambroxol 30 mg tablets and capsules were considered bioequivalent to the reference formulation in accordance with predetermined regulatory criteria.

  12. Cardiorespiratory responses of air filtration: A randomized crossover intervention trial in seniors living in Beijing: Beijing Indoor Air Purifier StudY, BIAPSY.

    Science.gov (United States)

    Shao, Danqing; Du, Yipeng; Liu, Shuo; Brunekreef, Bert; Meliefste, Kees; Zhao, Qian; Chen, Jie; Song, Xiaoming; Wang, Meng; Wang, Juan; Xu, Hongbing; Wu, Rongshan; Wang, Tong; Feng, Baihuan; Lung, Candice Shih-Chun; Wang, Xian; He, Bei; Huang, Wei

    2017-12-15

    In this Beijing Indoor Air Purifier StudY (BIAPSY), we conducted a randomized crossover intervention trial in a panel of 35 non-smoking senior participants with free-living, with and without chronic obstructive pulmonary disease (COPD). Portable air filtration units were randomly allocated to active-(filter in) for 2weeks and sham-mode (filter out) for 2weeks in the households. We examined the differences in indoor air pollutant concentrations in 20 study homes and a suite of cardio-respiratory biomarker levels in study participants between filtration modes, with and without adjustment for potential confounders. Following active filtration, we observed significant reductions from 60±45 to 24±15μg/m 3 in ten-day averages of indoor PM 2.5 and reductions from 3.87±1.65 to 1.81±1.19m -1 .10 -5 in ten-day averages of indoor BC, compared to sham-mode filtration. The major components of indoor PM 2.5 , including water soluble organics, NO 3 - , SO 4 2- , Zn 2+ , Pb 2+ and K + , were also reduced significantly by 42% to 63%. However, following active filtration, we only observed significant reductions on systemic inflammation measured as of IL-8 at 58.59% (95% CI: -76.31, -27.64) in the total group of participants and 70.04% (95% CI: -83.05, -47.05) in the subset of COPD patients, with adjustments. We were not able to detect improvements on lung function, blood pressure, and heart rate variability, following short-term intervention of two-week active air filtration. In conclusion, our results showed that indoor air filtration produced clear improvement on indoor air quality, but no demonstrable changes in the cardio-respiratory outcomes of study interest observed in the seniors living with real-world air pollution exposures. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. Effect of sleep deprivation after a night shift duty on simulated crisis management by residents in anaesthesia. A randomised crossover study.

    Science.gov (United States)

    Arzalier-Daret, Ségolène; Buléon, Clément; Bocca, Marie-Laure; Denise, Pierre; Gérard, Jean-Louis; Hanouz, Jean-Luc

    2017-09-04

    Sleep deprivation has been associated with an increased incidence of medical errors and can jeopardise patients' safety during medical crisis management. The aim of the study was to assess the effect of sleep deprivation on the management of simulated anaesthesia crisis by residents in anaesthesiology. A randomised, comparative, monocentric crossover study involving 48 residents in anaesthesia was performed on a high fidelity patient simulator. Each resident was evaluated in a sleep-deprived state (deprived group, after a night shift duty) and control state (control group, after a night of sleep). Performance was assessed through points obtained during crisis scenario 1 (oesophageal intubation followed by anaphylactic shock) and scenario 2 (anaesthesia-related bronchospasm followed by ventricular tachycardia). Sleep periods were recorded by actigraphy. Two independent observers assessed the performances. The primary endpoint of the study was the score obtained for each scenario. Resident's crisis management performance is associated with sleep deprivation (scenario 1: control=39 [33-42] points vs. deprived=26 [19-40] points, P=0.02; scenario 2: control=21 [17-24] vs. deprived=14 [12-19], P=0.01). The main errors observed were: error in drug administration and dose, delay in identification of hypotension, and missing communication with the surgical team about situation. The present study showed that sleep deprivation is associated with impairment of performance to manage crisis situations by residents in anaesthesia. Copyright © 2017 Société française d'anesthésie et de réanimation (Sfar). Published by Elsevier Masson SAS. All rights reserved.

  14. To establish whether McKenzie lumbar flexion and extension mobility exercises performed in lying affect central as well as systemic hemodynamics: a crossover experimental study.

    Science.gov (United States)

    Al-Obaidi, Saud M; Asbeutah, Akram; Al-Sayegh, Nowall; Dean, Elizabeth

    2013-09-01

    Examine systemic and central hemodynamic responses following McKenzie lumbar flexion and extension mobility exercises performed in lying (FIL and EIL). Crossover experimental study. Clinical laboratory. Healthy male volunteers (n=25) (mean(SD) age: 28(3)years; range 21 to 34). Based on alternating assignment of either FIL or EIL to participants, three sets of the first exercise (10, 15, 20 repetitions) were performed with 5-minute rest between sets; after 15-minute rest, the protocol was repeated for the other exercise. Systemic hemodynamic parameters included heart rate (HR), and systolic and diastolic blood pressures (SBP, DBP). Central hemodynamic parameters included abdominal aortic diameter (AD), peak systolic velocity (PSV/AD), end diastolic velocity (EDV/AD) and resistive index (RI). Measures recorded after each exercise set. FIL RPP at baseline was 9.1 (1.4), after 20 repetitions 18.3 (2.5), mean difference 8.9 (95% confidence interval (CI) 7.9 to 9.8) compared to EIL at baseline 9.1 (1.5), after 20 repetitions 13.0 (3.1), mean difference 4.1 (95% CI 3.3 to 5.0). FIL RI at baseline was 0.78 (0.03), after 20 repetitions 0.87 (0.03), mean difference 0.08 (95% CI 0.06 to 0.10) compared to EIL at baseline 0.78 (0.03), after 20 repetitions 0.83 (0.03), mean difference 0.05 (95% CI 0.04 to 0.07). Although 10 repetitions of FIL and EIL may be regarded as safe, our findings support screening patients with lifestyle risk factors, and cautioning about adhering to recommended repetition number given associated increased work of the heart. The extent of AD mechanical perturbation remains unclear. Copyright © 2012 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  15. Impact of post-meal and one-time daily exercise in patient with type 2 diabetes mellitus: a randomized crossover study.

    Science.gov (United States)

    Pahra, Daizy; Sharma, Nitasha; Ghai, Sandhya; Hajela, Abhishek; Bhansali, Shobhit; Bhansali, Anil

    2017-01-01

    To evaluate the effectiveness of short-timed post-meal and one-time daily exercise on glycemic control in patients with T2DM. Sixty-four T2DM patients were randomised into crossover design. Group A (n = 32) underwent post-meal exercise (moderate-intensity brisk walking covering 1500-1600 steps for 15 min, starting 15 min after each meal) from d1 to d60 followed by one-time daily exercise (45 min pre-breakfast brisk walking at stretch covering 4500-4800 steps) from d61 to d120, while it was vice versa for the group B (n = 32). The five-point blood glucose profile was performed on d1, d30, d60, d90 and d120, and HbA1c on d1, d60 and d120. Fitness wrist band was used for step-counting to ensure the intensity of exercise and compliance to exercise protocol. Group A patients showed a significant improvement in five point blood glucose profile and HbA1c after performing post-meal exercise (p exercise (p exercise, as compared to one-time daily exercise. Further, on pooled analysis (post-meal versus one-time daily exercise group) the beneficial effect of post-meal exercise on glucose profile and HbA1c was consistent as compared to one time daily exercise and the significance persisted on comparison between the two groups. No hypoglycemic events were noted between the groups during the study period. Post-meal exercise is more effective than routine one-time daily exercise for glycemic control in T2DM patients.

  16. A pilot longitudinal study of the use of waxy maize heat modified starch in the treatment of adults with glycogen storage disease type I: a randomized double-blind cross-over study.

    Science.gov (United States)

    Bhattacharya, Kaustuv; Mundy, Helen; Lilburn, Maggie F; Champion, Michael P; Morley, David W; Maillot, François

    2015-02-15

    Uncooked corn-starch (UCCS) has been the mainstay of therapy for the hepatic glycogen storage diseases (GSD) but is not always effective. A new starch (WMHMS) has demonstrated a more favourable short-term metabolic profile. To determine efficacy and safety of a new uncooked starch (WMHMS) compared to UCCS over 16 weeks treatment with each. A double-blind cross-over study of 10 adults (aged 16 - 38 years, six male) with GSD Ia and Ib. After an individualised fast, subjects were randomised to take a 50 g starch-load of either WMHMS or UCCS. Starch-loads terminated when blood glucose was starch administration schedule recommended. Each starch was delivered in coded sachets and intake was monitored for the following 16 weeks. After a washout period, the protocol was repeated with the alternative product. 4 subjects failed to establish therapy on the cross-over limb. Data from 7 paired starch load showed: longer median fasting duration with WMHMS (7.5 versus 5 hours; p = 0.023), slower decrease in the glucose curve (0.357 versus 0.632 mmol/hr p = 0.028) and less area under insulin curves for the first 4 hours (p = 0.03). Two of six subjects took 50% or less WMHMS compared to UCCS and one took more. Plasma triglycerides, cholesterol and uric acid were unchanged after each study phase. WMHMS leads to significant reduction in insulin release and reduced starch use in some GSD patients.

  17. Black tea consumption improves postprandial glycemic control in normal and pre-diabetic subjects: a randomized, double-blind, placebo-controlled crossover study.

    Science.gov (United States)

    Butacnum, Arisa; Chongsuwat, Rewadee; Bumrungpert, Akkarach

    2017-01-01

    Postprandial glycemic control is important for prevention of diabetes. Black tea consumption may improve postprandial glycemic control. The major bioactive compounds are polyphenols, black tea polymerized polyphenol (BTPP).This study examined the effect of black tea consumption on postprandial blood glucose and insulin response following sucrose loading in normal and pre-diabetes subjects. This study was a randomized, double-blind, placebo-controlled crossover study. Twenty-four subjects, male and female aged 20-60 years, normal and pre-diabetic, randomly ingested a sucrose solution with a low dose (110 mg BTPP), a high dose (220 mg BTPP) of black tea drink or a placebo drink (0 mg BTPP). Blood samples were collected at 0, 30, 60, 90, and 120 min from commencement of drink ingestion to measure blood glucose and insulin levels. The drink containing low dose and high dose BTPP significantly decreased incremental blood glucose area under the curve (AUC) after sucrose intake compared with placebo in the normal (T0-60 min 3,232±356 vs 3,295±312 vs 3,652±454 mg.min/dL; p=0.016) and pre-diabetic subjects (T0-60 min 2,554±395 vs 2,472±280 vs 2,888±502 mg.min/dL; p=0.048). There was no statistically significant difference of changes in insulin levels between the placebo and black tea groups (p>0.05). No significant differences in adverse effects were observed with the placebo, low dose and high dose of BTPP groups. Black tea consumption can decrease postprandial blood glucose after sucrose intake.

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

    Science.gov (United States)

    Rogan, Slavko; Schmidtbleicher, Dietmar; Radlinger, Lorenz

    2014-10-01

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

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

    Science.gov (United States)

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

    2015-10-01

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

  20. Can dialysis modality influence quality of life in chronic hemodialysis patients? Low-flux hemodialysis versus high-flux hemodiafiltration: a cross-over study.

    Science.gov (United States)

    Kantartzi, Konstantia; Panagoutsos, Stelios; Mourvati, Efthemia; Roumeliotis, Athanasios; Leivaditis, Konstantinos; Devetzis, Vassilios; Passadakis, Ploumis; Vargemezis, Vassilios

    2013-01-01

    Hemodiafiltration with online preparation of the substitution [online high-flux hemodiafiltration (OHDF)] and hemodiafiltration with prepared bags of substitution (HDF) are important, recently widely used renal replacement therapies in patients with end-stage renal disease. However, there is little information on the comparative impacts of these modalities versus conventional low-flux hemodialysis (HD) on the quality of life (QoL) of HD patients. This study investigates the effect of dialysis modality on QoL in chronic HD patients. In this prospective, randomized, cross-over, open label study, 24 patients were enrolled. Their age were 62 ± 13.34 years (mean ± SD), with the duration of dialysis of 31 ± 23.28 months (mean ± SD). Five of the patients were women. QoL was measured by the Short-Form Health Survey with 36 questions (SF-36) and subscale scores were calculated. Each patient received HD, OHDF, and HDF for 3 months, with the dialysis modality subsequently being altered. They completed the questionnaire of QoL at the end of each period. There were statistical significant differences in QoL for the total SF-36 [36.1 (26.7-45.7) and 40.7 (30.2-62.8)], for classic low-flux HD and high-flux hemodiafiltration, for bodily pain [45 (26.9-66.9) and 55 (35.6-87.5)], and for role limitations due to emotional functioning [0 (0-33.3) and 33.3 (0-100)], respectively. The scores did not differ significantly between the two types of hemodiafiltration. Our study indicates that QoL differs significantly among patients receiving low-flux HD and high-flux hemodiafiltration, on total SF-36, bodily pain, and role limitations due to emotional functioning. Convective modalities may offer better QoL than diffusive HD.

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

    Science.gov (United States)

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

    2017-03-01

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

  2. Risk of sudden cardiac death in relation to season-specific cold spells: a case-crossover study in Finland.

    Science.gov (United States)

    Ryti, Niilo R I; Mäkikyrö, Elina M S; Antikainen, Harri; Hookana, Eeva; Junttila, M Juhani; Ikäheimo, Tiina M; Kortelainen, Marja-Leena; Huikuri, Heikki V; Jaakkola, Jouni J K

    2017-11-10

    To test a priori hypothesis of an association between season-specific cold spells and sudden cardiac death (SCD). We conducted a case-crossover study of 3614 autopsy-verified cases of SCD in the Province of Oulu, Finland (1998-2011). Cold spell was statistically defined by applying an individual frequency distribution of daily temperatures at the home address during the hazard period (7 days preceding death) and 50 reference periods (same calendar days of other years) for each case using the home coordinates. Conditional logistic regression was applied to estimate ORs for the association between the occurrence of cold spells and the risk of SCD after controlling for temporal trends. The risk of SCD was associated with a preceding cold spell (OR 1.33; 95% CI 1.00, 1.78). A greater number of cold days preceding death increased the risk of SCD approximately 19% per day (OR 1.19; 95% CI 1.07 to 1.32). The association was strongest during autumn (OR 2.51; 95% CI 1.27 to 4.96) and winter (OR 1.70; 95% CI 1.13 to 2.55) and lowest during summer (OR 0.42; 95% CI 0.15 to 1.18) and spring (OR 0.89; 95% CI 0.45 to 1.79). The association was stronger for ischaemic (OR 1.55; 95% CI 1.12 to 2.13) than for non-ischaemic SCD (OR 0.68; 95% CI 0.32 to 1.45) verified by medicolegal autopsy. Our results indicate that there is an association between cold spells and SCD, that this association is strongest during autumn, when the weather event is prolonged, and with cases suffering ischaemic SCD. These findings are subsumed with potential prevention via weather forecasting, medical advice and protective behaviour. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  3. Whey Protein Supplementation Enhances Whole Body Protein Metabolism and Performance Recovery after Resistance Exercise: A Double-Blind Crossover Study

    Directory of Open Access Journals (Sweden)

    Daniel W. D. West

    2017-07-01

    Full Text Available No study has concurrently measured changes in free-living whole body protein metabolism and exercise performance during recovery from an acute bout of resistance exercise. We aimed to determine if whey protein ingestion enhances whole body net protein balance and recovery of exercise performance during overnight (10 h and 24 h recovery after whole body resistance exercise in trained men. In a double-blind crossover design, 12 trained men (76 ± 8 kg, 24 ± 4 years old, 14% ± 5% body fat; means ± standard deviation (SD performed resistance exercise in the evening prior to consuming either 25 g of whey protein (PRO; MuscleTech 100% Whey or an energy-matched placebo (CHO immediately post-exercise (0 h, and again the following morning (~10 h of recovery. A third randomized trial, completed by the same participants, involving no exercise and no supplement served as a rested control trial (Rest. Participants ingested [15N]glycine to determine whole body protein kinetics and net protein balance over 10 and 24 h of recovery. Performance was assessed pre-exercise and at 0, 10, and 24 h of recovery using a battery of tests. Net protein balance tended to improve in PRO (P = 0.064; effect size (ES = 0.61, PRO vs. CHO during overnight recovery. Over 24 h, net balance was enhanced in PRO (P = 0.036 but not in CHO (P = 0.84; ES = 0.69, PRO vs. CHO, which was mediated primarily by a reduction in protein breakdown (PRO < CHO; P < 0.01. Exercise decreased repetitions to failure (REP, maximal strength (MVC, peak and mean power, and countermovement jump performance (CMJ at 0 h (all P < 0.05 vs. Pre. At 10 h, there were small-to-moderate effects for enhanced recovery of the MVC (ES = 0.56, mean power (ES = 0.49, and CMJ variables (ES: 0.27–0.49 in PRO. At 24 h, protein supplementation improved MVC (ES = 0.76, REP (ES = 0.44, and peak power (ES = 0.55. In conclusion, whey protein supplementation enhances whole body anabolism, and may improve acute recovery of

  4. Effect of ewe’s (semi-skimmed and whole) and cow’s milk yogurt consumption on the lipid profile of control subjects: a crossover study

    OpenAIRE

    Olmedilla-Alonso, Begoña; Nova-Rebato, Esther; García-González, Natalia; Martín-Diana, Ana-Belén; Fontecha, Javier; Delgado, David; Gredilla, Ana-Elisa; Bueno, Francisco; Asensio-Vegas, Carmen

    2017-01-01

    ABSTRACT Yogurt is the most widely consumed fermented milk product worldwide. Studies have mainly used milk and dairy products from cow, which have a lower fat content than those from ewe and a different lipid profile. This study investigated the effect on the lipid profile of control subjects of three different set yogurts: (a) semi-skimmed ewe´s milk yogurt (2.8% milk fat); (b) whole ewe´s milk yogurt (5.8 % milk fat); (c) cow´s milk yogurt (3 % milk fat). A randomized crossover study inclu...

  5. 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

  6. Death of a Close Relative and the Risk of Suicide in Sweden-A Large Scale Register-Based Case-Crossover Study.

    Directory of Open Access Journals (Sweden)

    Hanna Mogensen

    Full Text Available Bereavement is thought to be a risk factor for suicide but the association has not been thoroughly investigated according to specific sensitive time periods and risk groups using a self-matched design. We aimed to 1 determine the risk of suicide within the first year after death of a close relative, 2 investigate if and how the risk changes within this time window and 3 determine if sex, age, and type of relationship, affect this association.A self-matched, case-crossover study was performed by linking Swedish registers. In total, 31 059 individuals with suicide between 1990 and 2011 were included. Different periods within the year prior to the suicide were compared with corresponding periods one year earlier in the same individual's life. Conditional logistic regression was used to calculate odds ratios (OR and 95% confidence intervals (CI for suicide after death of a close relative.Increased ORs of suicide were seen during the first month, OR 1·77 (95% CI 1·35-2·34, and the first half-year, 1·27 (1·13-1·43. An even higher OR was found within the first week, 3·43 (1·89-6·22. Patterns were similar for women and men and across age groups. Death of a partner or child but not death of a sibling or parent was associated with a significantly increased suicide risk. The strongest association was seen after death of a partner in individuals aged 45 and older.These findings provide knowledge of sensitive time periods and at-risk groups in the early period of bereavement. Due to the use of a self-matched study design, methodological challenges of unmeasured residual confounding could be overcome.

  7. A randomized crossover clinical study showing that methylphenidate-SODAS improves attention-deficit/hyperactivity disorder symptoms in adolescents with substance use disorder

    Directory of Open Access Journals (Sweden)

    C.M. Szobot

    2008-03-01

    Full Text Available Our objective was to evaluate the effectiveness of a long-acting formulation of methylphenidate (MPH-SODAS on attention-deficit/hyperactivity disorder (ADHD symptoms in an outpatient sample of adolescents with ADHD and substance use disorders (SUD. Secondary goals were to evaluate the tolerability and impact on drug use of MPH-SODAS. This was a 6-week, single-blind, placebo-controlled crossover study assessing efficacy of escalated doses of MPH-SODAS on ADHD symptoms in 16 adolescents with ADHD/SUD. Participants were randomly allocated to either group A (weeks 1-3 on MPH-SODAS, weeks 4-6 on placebo or group B (reverse order. The primary outcome measures were the Swanson, Nolan and Pelham Scale, version IV (SNAP-IV and the Clinical Global Impression Scale (CGI. We also evaluated the adverse effects of MPH-SODAS using the Barkley Side Effect Rating Scale and subject reports of drug use during the study. The sample consisted of marijuana (N = 16; 100% and cocaine users (N = 7; 43.8%. Subjects had a significantly greater reduction in SNAP-IV and CGI scores (P < 0.001 for all analyses during MPH-SODAS treatment compared to placebo. No significant effects for period or sequence were found in analyses with the SNAP-IV and CGI scales. There was no significant effect on drug use. MPH-SODAS was well tolerated but was associated with more severe appetite reduction than placebo (P < 0.001. MPH-SODAS was more effective than placebo in reducing ADHD symptoms in a non-abstinent outpatient sample of adolescents with comorbid SUD. Randomized clinical trials, with larger samples and SUD intervention, are recommended.

  8. An interactive sports video game as an intervention for rehabilitation of community-living patients with schizophrenia: A controlled, single-blind, crossover study.

    Science.gov (United States)

    Shimizu, Nobuko; Umemura, Tomohiro; Matsunaga, Masahiro; Hirai, Takayoshi

    2017-01-01

    Hypofrontality is a state of decreased cerebral blood flow in the prefrontal cortex during executive function performance; it is commonly observed in patients with schizophrenia. Cognitive dysfunction, as well as the psychological symptoms of schizophrenia, influences the ability of patients to reintegrate into society. The current study investigated the effects of an interactive sports video game (IVG; Nintendo Wii™ Sports Resort) on frontal lobe function of patients with schizophrenia. A sample of eight patients (6 male and 2 female; mean age = 46.7 years, standard deviation (SD) = 13.7) engaged in an IVG every week for 3 months in a controlled, single-blind, crossover study. Before and after the intervention we examined frontal lobe blood-flow volume using functional near-infrared spectroscopy (fNIRS), and assessed functional changes using the Frontal Assessment Battery, Health-Related Quality of Life scale, and behaviorally-assessed physical function tests. fNIRS revealed that prefrontal activity during IVG performance significantly increased in the IVG period compared with the control period. Furthermore, significant correlations between cerebral blood flow changes in different channels were observed during IVG performance. In addition, we observed intervention-related improvement in health-related quality of life following IVG. IVG intervention was associated with increased prefrontal cortex activation and improved health-related quality of life performance in patients with schizophrenia. Patients with chronic schizophrenia are characterized by withdrawal and a lack of social responsiveness or interest in others. Interventions using IVG may provide a useful low-cost rehabilitation method for such patients, without the need for specialized equipment.

  9. An interactive sports video game as an intervention for rehabilitation of community-living patients with schizophrenia: A controlled, single-blind, crossover study

    Science.gov (United States)

    Umemura, Tomohiro; Matsunaga, Masahiro; Hirai, Takayoshi

    2017-01-01

    Hypofrontality is a state of decreased cerebral blood flow in the prefrontal cortex during executive function performance; it is commonly observed in patients with schizophrenia. Cognitive dysfunction, as well as the psychological symptoms of schizophrenia, influences the ability of patients to reintegrate into society. The current study investigated the effects of an interactive sports video game (IVG; Nintendo Wii™ Sports Resort) on frontal lobe function of patients with schizophrenia. A sample of eight patients (6 male and 2 female; mean age = 46.7 years, standard deviation (SD) = 13.7) engaged in an IVG every week for 3 months in a controlled, single-blind, crossover study. Before and after the intervention we examined frontal lobe blood-flow volume using functional near-infrared spectroscopy (fNIRS), and assessed functional changes using the Frontal Assessment Battery, Health-Related Quality of Life scale, and behaviorally-assessed physical function tests. fNIRS revealed that prefrontal activity during IVG performance significantly increased in the IVG period compared with the control period. Furthermore, significant correlations between cerebral blood flow changes in different channels were observed during IVG performance. In addition, we observed intervention-related improvement in health-related quality of life following IVG. IVG intervention was associated with increased prefrontal cortex activation and improved health-related quality of life performance in patients with schizophrenia. Patients with chronic schizophrenia are characterized by withdrawal and a lack of social responsiveness or interest in others. Interventions using IVG may provide a useful low-cost rehabilitation method for such patients, without the need for specialized equipment. PMID:29131826

  10. An interactive sports video game as an intervention for rehabilitation of community-living patients with schizophrenia: A controlled, single-blind, crossover study.

    Directory of Open Access Journals (Sweden)

    Nobuko Shimizu

    Full Text Available Hypofrontality is a state of decreased cerebral blood flow in the prefrontal cortex during executive function performance; it is commonly observed in patients with schizophrenia. Cognitive dysfunction, as well as the psychological symptoms of schizophrenia, influences the ability of patients to reintegrate into society. The current study investigated the effects of an interactive sports video game (IVG; Nintendo Wii™ Sports Resort on frontal lobe function of patients with schizophrenia. A sample of eight patients (6 male and 2 female; mean age = 46.7 years, standard deviation (SD = 13.7 engaged in an IVG every week for 3 months in a controlled, single-blind, crossover study. Before and after the intervention we examined frontal lobe blood-flow volume using functional near-infrared spectroscopy (fNIRS, and assessed functional changes using the Frontal Assessment Battery, Health-Related Quality of Life scale, and behaviorally-assessed physical function tests. fNIRS revealed that prefrontal activity during IVG performance significantly increased in the IVG period compared with the control period. Furthermore, significant correlations between cerebral blood flow changes in different channels were observed during IVG performance. In addition, we observed intervention-related improvement in health-related quality of life following IVG. IVG intervention was associated with increased prefrontal cortex activation and improved health-related quality of life performance in patients with schizophrenia. Patients with chronic schizophrenia are characterized by withdrawal and a lack of social responsiveness or interest in others. Interventions using IVG may provide a useful low-cost rehabilitation method for such patients, without the need for specialized equipment.

  11. The effect of lactose-isomaltulose-containing growing-up milks on cognitive performance of Indonesian children: a cross-over study.

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    Sekartini, Rini; Wiguna, Tjhin; Bardosono, Saptawati; Novita, Dian; Arsianti, Tiana; Calame, Wim; Schaafsma, Anne

    2013-09-28

    Glycaemic response to dietary carbohydrates might have an impact on cognitive performance. The present study investigated the effects of growing-up milks (GUM) with isomaltulose and extra minerals and vitamins or lower protein content on cognitive parameters in children aged 5–6 years. In a blinded, partly randomised, controlled, cross-over study, four GUM were provided, each taken over 14 d (2 × 200 ml/d): standard (Std) GUM; Std GUM+5 g isomaltulose (Iso-5 GUM); Iso-5 GUM with 26 % less protein (Iso-5 LP GUM); Std GUM with 2·5 g isomaltulose and extra Mg, Zn, Se, D3, B1, B2, B12, folic acid and choline (Iso-2·5 GUM). At test days, when GUM replaced breakfast, repeated (0, 60, 120 and 180 min post-dose) cognitive tasks were performed (picture presentation, simple reaction time, digit vigilance, choice reaction time, spatial and numeric working memory and picture recognition). Task performance of all subjects (n 50) worsened over the morning. Best performance was seen on isomaltulose GUM, most notably at 180 min. Iso-2·5 GUM showed best performance on several parameters of attention and memory, Iso-5 GUM performed best on parameters of memory and Iso-5 LP GUM was positively associated with parameters of attention but less with memory. Std GUM showed only a benefit on one attention and one memory task. Thus, isomaltulose-enriched GUM positively affected parameters of attention and memory at 180 min post-dose when compared with Std GUM. Extra minerals and vitamins seem beneficial, whereas lowering protein content might improve attention in particular.

  12. The effect of high lactose-isomaltulose on cognitive performance of young children. A double blind cross-over design study.

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    Taib, Mohd Nasir Mohd; Shariff, Zalilah Mohd; Wesnes, Keith A; Saad, Hazizi Abu; Sariman, Sarina

    2012-02-01

    Changes in blood glucose are hypothesized to influence cognitive performance and these changes can be affected by certain nutrients. This double-blind 4-period cross-over study evaluated the effects of a slow-release modified sucrose (isomaltulose) in combination with a high concentration of lactose on cognitive performance of 5-6 year old children. Thirty children received a standard growing upmilk (Std GUM), reformulated growing up milk (Reform GUM), standard growing up milk with lactose-isomaltulose (Iso GUM), and a standard glucose drink (Glucose). The CDR System, a computerised cognitive assessment system, was used to assess various measures of attention and memory of the children at baseline (T=0), 60 (T=1), 120 (T=2), and 180 (T=3) minutes following the intake of test products. Overall, there was a decline in performance over the morning on almost every cognitive task. Children showed better attention following consumption of Iso GUM compared to Std GUM but attention was not significantly different than Reform GUM and glucose. Also, Iso GUM conferred a beneficial effect over both Reform GUM and glucose on sensitivity index of numeric working memory with no difference observed between Iso GUM and Std GUM. Surprisingly, glucose group showed lowest decline in the sensitivity index of spatial working memory and highest speed in picture recognition, although the latter was significantly better than Reform GUM only. For speed of spatial working memory, Reform GUM had the lowest decline but was significantly different only with Std GUM. There was, however, no significant difference among conditions for continuity of attention, speed of numeric working memory and picture recognition sensitivity. Despite the small sample size, the findings are intriguing as carbohydrate composition seems to influence some aspects of cognitive performance such as attention and memory. However, further studies are needed to confirm these findings. Copyright © 2011 Elsevier Ltd. All

  13. Airtraq Laryngoscope Versus the Conventional Macintosh Laryngoscope During Pediatric Intubation Performed by Nurses: A Randomized Crossover Manikin Study With Three Airway Scenarios.

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    Szarpak, Łukasz; Karczewska, Katarzyna; Czyżewski, Łukasz; Truszewski, Zenon; Kurowski, Andrzej

    2017-11-01

    We hypothesized that the Airtraq laryngoscope (Airtraq LLC, Bonita Springs, Fla) is beneficial for intubation of pediatric manikins while performing cardiopulmonary resuscitation (CPR). In the present study, we evaluated the effectiveness of the Macintosh (MAC) laryngoscope (HEINE Optotechnik, Munich, Germany) and Airtraq in 3 simulated CPR scenarios. A randomized crossover simulation trial was designed. Eighty-three nurses intubated the trachea of a PediaSIM CPR training manikin (FCAE HealthCare, Sarasota, Fla) using the MAC and Airtraq in a normal airway scenario, normal airway with chest compression scenario, and difficult airway with chest compression scenario. The participants were directed to perform a maximum of 3 attempts in each scenario. The success rate, time to intubation, Cormack & Lehane grade, dental compression, and the ease of intubation were measured. All participants performed successful intubation with the Airtraq in all 3 scenarios. In all scenarios, the success rate was significantly higher and the time to intubation was significantly shorter with the Airtraq than with the MAC. Glottic visualization using the Cormack-Lehane scale was also better when using Airtraq in all scenarios. In this manikin study, we found that the Airtraq can be used successfully for the intubation of pediatric manikins with normal and difficult airways by medical staff without previous experience in pediatric intubation. Moreover, intubation can be achieved without interrupting chest compression. The use of the Airtraq compared with the MAC led to faster time to intubation. Nevertheless, we recommend that the performance of the Airtraq and the MAC during CPR should be further evaluated in a clinical setting.

  14. Randomized two-way cross-over bioequivalence study of two amoxicillin formulations and inter-ethnicity pharmacokinetic variation in healthy Malay volunteers.

    Science.gov (United States)

    Liew, Kai Bin; Loh, Gabriel Onn Kit; Tan, Yvonne Tze Fung; Peh, Kok Khiang

    2014-09-01

    The objectives of this study were to develop a new deproteinization method to extract amoxicillin from human plasma and evaluate the inter-ethnic variation of amoxicillin pharmacokinetics in healthy Malay volunteers. A single-dose, randomized, fasting, two-period, two-treatment, two-sequence crossover, open-label bioequivalence study was conducted in 18 healthy Malay adult male volunteers, with one week washout period. The drug concentration in the sample was analyzed using high-performance liquid chromatography (UV-vis HPLC). The mean (standard deviation) pharmacokinetic parameter results of Moxilen® were: peak concentration (Cmax ), 6.72 (1.56) µg/mL; area under the concentration-time graph (AUC0-8 ), 17.79 (4.29) µg/mL h; AUC0-∞ , 18.84 (4.62) µg/mL h. Those of YSP Amoxicillin® capsule were: Cmax , 6.69 (1.44) µg/mL; AUC0-8 , 18.69 (3.78) µg/mL h; AUC00-∞ , 19.95 (3.81) µg/mL h. The 90% confidence intervals for the logarithmic transformed Cmax , AUC0-8 and AUC0-∞ of Moxilen® vs YSP Amoxicillin® capsule was between 0.80 and 1.25. Both Cmax and AUC met the predetermined criteria for assuming bioequivalence. Both formulations were well tolerated. The results showed significant inter-ethnicity variation in pharmacokinetics of amoxicillin. The Cmax and AUC of amoxicillin in Malay population were slightly lower compared with other populations. Copyright © 2014 John Wiley & Sons, Ltd.

  15. Effect of pressure-controlled inverse ratio ventilation on dead space during robot-assisted laparoscopic radical prostatectomy: A randomised crossover study of three different ventilator modes.

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    Hirabayashi, Go; Ogihara, Yukihiko; Tsukakoshi, Shoichi; Daimatsu, Kiyoshi; Inoue, Masaaki; Kurahashi, Kiyoyasu; Maruyama, Koichi; Andoh, Tomio

    2018-01-04

    Pressure-controlled inverse inspiratory to expiratory ratio ventilation (PC-IRV) is thought to be beneficial for reducing the dead space volume. To investigate the effects of PC-IRV on the components of dead space during robot-assisted laparoscopic radical prostatectomy (RLRP). A randomised crossover study of three different ventilator modes. A single university hospital from September 2014 to April 2015. Twenty consecutive study participants undergoing RLRP. Patients were ventilated sequentially with three different modes in random order for 30 min: volume control ventilation (VCV; inspiratory to expiratory ratio 0.5), pressure control ventilation (PCV; inspiratory to expiratory ratio 0.5) and PC-IRV. Inverse inspiratory to expiratory ratio was adjusted individually by observing the expiratory flow-time wave to prevent the risk of dynamic pulmonary hyperinflation. The primary outcome included physiological dead space (VDphys), airway dead space (VDaw), alveolar dead space (VDalv) and shunt dead space (VDshunt). VDphys was calculated by Enghoff's method. We also analysed respiratory dead space (VDresp) and VDaw using a novel analytical method. Then, VDalv and VDshunt were calculated by VDalv = VDresp - VDaw and VDshunt = VDphys - VDresp, respectively. The VDphys/expired tidal volume (VTE) ratio in PC-IRV (29.2 ± 4.7%) was significantly reduced compared with that in VCV (43 ± 8.5%) and in PCV (35.9 ± 3.9%). The VDshunt/VTE in PC-IRV was significantly smaller than that in VCV and PCV. VDaw/VTE in PC-IRV was also significantly smaller than that in VCV but not that in PCV. There was no significant change in VDalv/VTE. PC-IRV with the inspiratory to expiratory ratio individually adjusted by the expiratory flow-time wave decreased VDphys/VTE in patients undergoing RLRP. University Hospital Medical Information Network in Japan 000014004.

  16. Comparison of 2 resident learning tools-interactive screen-based simulated case scenarios versus problem-based learning discussions: a prospective quasi-crossover cohort study.

    Science.gov (United States)

    Rajan, Shobana; Khanna, Ashish; Argalious, Maged; Kimatian, Stephen J; Mascha, Edward J; Makarova, Natalya; Nada, Eman M; Elsharkawy, Hesham; Firoozbakhsh, Farhad; Avitsian, Rafi

    2016-02-01

    Simulation-based learning is emerging as an alternative educational tool in this era of a relative shortfall of teaching anesthesiologists. The objective of the study is to assess whether screen-based (interactive computer simulated) case scenarios are more effective than problem-based learning discussions (PBLDs) in improving test scores 4 and 8 weeks after these interventions in anesthesia residents during their first neuroanesthesia rotation. Prospective, nonblinded quasi-crossover study. Cleveland Clinic. Anesthesiology residents. Two case scenarios were delivered from the Anesoft software as screen-based sessions, and parallel scripts were developed for 2 PBLDs. Each resident underwent both types of training sessions, starting with the PBLD session, and the 2 cases were alternated each month (ie, in 1 month, the screen-based intervention used case 1 and the PBLD used case 2, and vice versa for the next month). Test scores before the rotation (baseline), immediately after the rotation (4 weeks after the start of the rotation), and 8 weeks after the start of rotation were collected on each topic from each resident. The effect of training method on improvement in test scores was assessed using a linear mixed-effects model. Compared to the departmental standard of PBLD, the simulation method did not improve either the 4- or 8-week mean test scores (P = .41 and P = .40 for training method effect on 4- and 8-week scores, respectively). Resident satisfaction with the simulation module on a 5-point Likert scale showed subjective evidence of a positive impact on resident education. Screen-based simulators were not more effective than PBLD for education during the neuroanesthesia rotation in anesthesia residency. Copyright © 2016 Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2015-05-01

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

  18. A randomized crossover clinical study showing that methylphenidate-SODAS improves attention-deficit/hyperactivity disorder symptoms in adolescents with