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Sample records for randomized two-way crossover

  1. Bioavailability of everolimus administered as a single 5 mg tablet versus five 1 mg tablets: a randomized, open-label, two-way crossover study of healthy volunteers.

    Science.gov (United States)

    Thudium, Karen; Gallo, Jorge; Bouillaud, Emmanuel; Sachs, Carolin; Eddy, Simantini; Cheung, Wing

    2015-01-01

    The mammalian target of rapamycin (mTOR) inhibitor everolimus has a well-established pharmacokinetics profile. We conducted a randomized, single-center, open-label, two-sequence, two-period crossover study of healthy volunteers to assess the relative bioavailability of everolimus administered as one 5 mg tablet or five 1 mg tablets. Subjects were randomized 1:1 to receive everolimus dosed as one 5 mg tablet or as five 1 mg tablets on day 1, followed by a washout period on days 8-14 and then the opposite formulation on day 15. Blood sampling for pharmacokinetic evaluation was performed at prespecified time points, with 17 samples taken for each treatment period. Primary variables for evaluation of relative bioavailability were area under the concentration-time curve from time zero to infinity (AUCinf) and maximum blood concentration (Cmax). Safety was assessed by reporting the incidence of adverse events (AEs). Twenty-two participants received everolimus as one 5 mg tablet followed by five 1 mg tablets (n=11) or the opposite sequence (n=11). The Cmax of five 1 mg tablets was 48% higher than that of one 5 mg tablet (geometric mean ratio, 1.48; 90% confidence interval [CI], 1.35-1.62). AUCinf was similar (geometric mean ratio, 1.08; 90% CI, 1.02-1.16), as were the extent of absorption and the distribution and elimination kinetics. AEs, all grade 1 or 2, were observed in 54.5% of subjects. Although the extent of absorption was similar, the Cmax of five 1 mg tablets was higher than that of one 5 mg tablet, suggesting these formulations lead to different peak blood concentrations and are not interchangeable at the dose tested.

  2. 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.

  3. Effects of food intake on the pharmacokinetics of diclofenac potassium soft gelatin capsules: a single-dose, randomized, two-way crossover study.

    Science.gov (United States)

    Scallion, Ralph; Moore, Keith A

    2009-10-01

    Diclofenac potassium liquid-filled soft gelatin capsule (DPSGC) is an investigational formulation that uses dispersing agents designed to facilitate rapid and consistent absorption of this NSAID. The aim of this study was to characterize the effects of food intake on the pharmacokinetic (PK) profile of oral DPSGC at doses of 25 and 50 mg. In this open-label, randomized, single-dose (2 distinct doses), 2-way crossover bioavailability study, healthy adult volunteers were randomly assigned to receive a single dose of DPSGC 25 or 50 mg after an overnight fast (fasted condition) or high-fat breakfast (fed condition) (period 1). After 7 days, the participants received the same dose under the opposite fed/fasted condition (period 2). Serial blood samples were obtained before and through 6 hours after study drug administration. Concentrations of diclofenac in plasma were determined using HPLC, and PK profiles were studied using ANCOVA. Adverse events (AEs) were monitored and recorded on each in-clinic day. Of 47 participants included in the study, 24 received the 25-mg dose of DPSGC and 23 received the 50-mg dose. The majority of participants were male (80.9%), and the mean age was 28.6 years. The mean (SD) AUC values for the fasted and fed states were 691 (195) and 680 (184) ng x h/mL, respectively, with the 25-mg dose, and 1521 (377) and 1416 (366) ng . h/mL, respectively, with the 50-mg dose, suggesting that the extent of absorption was similar with both dietary conditions at each dose. Food intake was associated with decreases in C(max) by nearly half in the 25-mg group (fasted vs fed, 1156 [482] vs 686 [411] ng/mL, respectively; P < 0.05) and the 50-mg group (2365 [1034] vs 1154 [592 ng/mL; P < 0.05) and delayed T(max) in the 25-mg group (0.49 [0.16] vs 1.02 [0.55] hours; P < 0.05) and 50-mg group (0.51 [0.19] vs 1.28 [0.71] hours; P < 0.05). Two mild AEs (nasal congestion and light-headedness) were reported in 2 participants who received 25 mg under fed conditions

  4. A single-dose, randomized, two-way crossover study comparing two olanzapine tablet products in healthy adult male volunteers under fasting conditions.

    Science.gov (United States)

    Elshafeey, Ahmed H; Elsherbiny, Mohamed A; Fathallah, Mohsen M

    2009-03-01

    Olanzapine is a psychotropic agent that belongs to the thienobenzodiazepine class. The aim of this study was to assess the bioequivalence of 2 commercial 10-mg tablet formulations of olanzapine by statistical analysis of the pharmacokinetic parameters C(max), AUC from 0 to 72 hours after dosing (AUC(0-72)), and AUC(0-infinity) as required by the Egyptian health authority for the marketing of a generic product. This bioequivalence study was carried out in healthy male volunteers using a single-dose, randomized, 2-way crossover design under fasting conditions. Statistical analysis of the pharmacokinetic parameters C(max), AUC(0-72), and AUC(0-infinity) was conducted to determine bioequivalence (after log-transformation of data using analysis of variance and 90% CIs) and to gain marketing approval in Egypt. The formulations were considered to be bioequivalent if the log-transformed ratios of the 3 pharmacokinetic parameters were within the predetermined bioequivalence range (ie, 80%-125%), as established by the US Food and Drug Administration (FDA). Both the test product (Trademark: Integrol((R)) [Global Napi Pharmaceuticals, Cairo, Egypt]) and the reference product (Trademark: Zyprexa((R)) [Eli Lilly and Company, Basingstoke, Hampshire, United Kingdom]) were administered as 10-mg tablets with 240 mL of water after an overnight fast on 2 treatment days, separated by a 2-week washout period. After dosing, serial blood samples were collected for 72 hours. Plasma samples were analyzed using a sensitive, reproducible, and accurate liquid chromatography-tandem mass spectrometry method capable of quantitating olanzapine in the range of 0.167 to 16.7 ng/mL, with a lower limit of quantitation of 0.167 ng/mL. Adverse events were reported by the volunteers as instructed or observed by the resident physician, and were recorded, tabulated, and evaluated. Twenty-four healthy adult male volunteers participated in this study. Their mean (SD) age was 24.7 (6.2) years (range, 19

  5. Relative bioavailability of levodropropizine 60 mg capsule and syrup formulations in healthy male Korean volunteers: a singledose, randomized-sequence, open-label, two-way crossover study.

    Science.gov (United States)

    Jang, Jae-Won; Seo, Ji-Hyung; Jo, Min-Ho; Lee, Young-Joo; Cho, Young-Wuk; Yim, Sung-Vin; Lee, Kyung-Tae

    2013-02-01

    Levodropropizine is an oral non-opioid anti-tussive drug used in treatment of cough. A new generic 60 mg capsule formulation of levodropropizine has recently been developed. The aim of this study was to assess the pharmacokinetics and bioequivalence of the test (capsule) formulation and reference (syrup) formulation of levodropropizine (60 mg) in healthy, fasted, male Korean volunteers. This was a single-dose, randomized sequence, open-label, 2-period crossover study conducted in healthy male Korean volunteers in the fasted state at Kyung Hee University Medical Center (Seoul, Republic of Korea). A single oral dose of the test or reference formulation was followed by a 1-week washout period, after which subjects received the alternative formulation. Blood samples were collected at 0 (predose), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after study drug administration. Plasma concentration of levodropropizine was determined using a validated liquid chromatography tandem mass spectrometry (LCMS/ MS) method. The formulations were considered bioequivalent if the 90% CIs for C(max), AUC(0-12h) and AUC(0-∞) were within the predetermined bioequivalence range (80 - 125%, according to the guidelines of the Korea Food and Drug Administration (Korea FDA)). Tolerability was evaluated throughout the study based on vital sign measurements, laboratory analysis (blood biochemistry, hematology, hepatic function and urinalysis) and subject interviews concerning adverse events (AEs). A total of 36 male Korean subjects (mean (SD) age, 23.9 (2.4) years (range 19 - 30 years); height, 176.2 (6.1) cm (range 161 - 190 cm); weight, 69.8 (9.1) kg (range 54.0 - 92.2 kg); body mass index, 22.4 (2.1) kg/m2 (range 19.1 - 28.3 kg/m2)) was enrolled and completed the study. The mean values for C(max), t(max), AUC(0-12h), and AUC(0-∞) with the test formulation of levodropropizine were 331.51 ng/ml, 0.60 hours, 784.32 ng×h/ml, and 825.82 ng×h/ml, respectively; for the reference

  6. Inhibitory effects of intravenous lansoprazole 30 mg and pantoprazole 40 mg twice daily on intragastric acidity in healthy Chinese volunteers: a randomized, open-labeled, two-way crossover study.

    Science.gov (United States)

    Zhan, Xian-Bao; Guo, Xiao-Rong; Li, Zhao-Shen; Gong, Yan-Fang; Gao, Jun; Liao, Zhuan; Li, Zhen; Gao, Shen; Liu, Pei

    2012-02-01

    Until now there has been no study that directly compares the effect of lansoprazole and pantoprazole administered intravenously on intragastric acidity. The aim of this study is to compare the effect of lansoprazole (30 mg) and pantoprazole (40 mg) administered intravenously on gastric acidity. Helicobacter pylori-negative healthy volunteers were recruited in this open-label, randomized, two-way crossover, single centre study. Lansoprazole at 30 mg or pantoprazole at 40 mg was intravenously administered twice daily for 5 consecutive days with at least a 14-day washout interval. Twenty-four-hour intragastric pH was continuously monitored on days 1 and 5 of each dosing period. Twenty-five volunteers completed the 2 dosing periods. The mean intragastric pH values were higher in subjects treated with lansoprazole than those with pantoprazole on both day 1 (6.41 ± 0.14 vs. 5.49 ± 0.13, P=0.0003) and day 5 (7.09 ± 0.07 vs. 6.64 ± 0.07, P=0.0002). Significantly higher percentages of time with intragastric pH >4 and pH >6 were found in the subjects treated with lansoprazole than those with pantoprazole on day 1 (pH >4, 87.12 ± 4.55% vs. 62.28 ± 4.15%, P=0.0012; pH >6, 62.12 ± 4.12% vs. 47.25 ± 3.76%, P=0.0216) and pH >6 on day 5 (76.79 ± 3.77% vs. 58.20 ± 3.77%, P=0.0025). Intravenous lansoprazole produces a longer and more potent inhibitory effect on intragastric acidity than does intravenous pantoprazole.

  7. Relative bioavailability of two formulations of nevirapine 200-mg tablets in healthy Chinese male volunteers: a single-dose, randomized-sequence, open-label, two-way crossover study.

    Science.gov (United States)

    Zhu, Yubing; Zhang, Qian; Yu, Cuixia; Zou, Jianjun; Yang, Xiaohong; Hu, Yunfang

    2010-12-01

    Nevirapine was the first member of the nonnucleoside reverse transcriptase inhibitor class to be approved for the treatment of HIV infection. It binds directly to the allosteric site on the reverse transcriptase and inhibits the activity of both RNA- and DNA-dependent DNA polymerases. This study compared the pharmacokinetics and relative bioavailability of a test and reference formulation of nevirapine 200-mg tablets after single oral doses in healthy Chinese men to meet regulatory criteria for marketing of the new generic formulation. This single-dose, randomized-sequence, open-label, 2-way crossover study was conducted at the Nanjing First Hospital of Nanjing Medical University, Nanjing, China. Healthy male Chinese volunteers were randomized in a 1∶1 ratio to receive a single 200-mg (3.2-mg/kg) tablet of the test or reference formulation, followed by a 2-week washout period and administration of the alternate formulation. The study drugs were administered after a 10-hour overnight fast. Concentrations of nevirapine were assayed using an HPLC-UV method. For analysis of nevirapine pharmacokinetic parameters, blood samples were obtained before dosing and at regularly scheduled intervals over 168 hours after administration. The 2 formulations would be assumed to be bioequivalent for regulatory purposes if the 90% CIs for the log-transformed ratios of nevirapine AUC and C(max) were within the range established by the US Food and Drug Administration (0.80-1.25). Tolerability was evaluated throughout the study based on vital signs, physical examinations, 12-lead ECGs, and subject interviews concerning adverse events (AEs). Twenty Chinese male subjects were enrolled in and completed the study. Their mean age was 23 years (range, 21-25 years), mean weight was 63 kg (range, 56-70 kg), and mean height was 171 cm (range, 166-176 cm). No period or sequence effect was observed. The mean (SD) t(½) was 38.12 (2.23) hours for the test tablet and 36.79 (5.06) hours for the

  8. Bioequivalence and pharmacokinetic evaluation of two formulations of risperidone 2 mg : an open-label, single-dose, fasting, randomized-sequence, two-way crossover study in healthy male Chinese volunteers.

    Science.gov (United States)

    Liu, Yun; Zhang, Meng-qi; Jia, Jing-ying; Liu, Yan-mei; Liu, Gang-yi; Li, Shui-jun; Wang, Wei; Weng, Li-ping; Yu, Chen

    2013-03-01

    Risperidone is a benzisoxazole derivate and is effective in the treatment of schizophrenia and other psychiatric illnesses in adults and children. Although there are a few reports in the literature regarding the pharmacokinetic characteristics of risperidone, insufficient data on its pharmacokinetic properties in a Chinese population are available. To meet the requirements for marketing a new generic product, this study was designed to compare the pharmacokinetic properties and bioequivalence of two 2 mg tablet formulations of risperidone: a newly developed generic formulation (test) and a branded formulation (reference) in healthy adult male Chinese volunteers. A single-dose, open-label, randomized-sequence, 2 × 2 crossover study was conducted in fasted healthy male Chinese volunteers. Eligible participants were randomly assigned in a 1:1 ratio to receive 1 tablet (2 mg each) of the test formulation (Risperidone tablet; Dr. Reddy's Laboratories Ltd., Hyderabad, India) or the reference formulation (Risperdal(®) tablet; Xian-Janssen Pharmaceutical Ltd., Xi-an, China), followed by a 2-week washout period and subsequent administration of the alternate formulation. The study drugs were administered after a 10-hour overnight fast. Plasma samples were collected over 96 hours. Plasma concentrations of the parent drug, risperidone, and its active metabolite, 9-hydroxy-risperidone, were analyzed by a liquid chromatography-tandem mass spectrometry method. The formulations would be considered bioequivalent if the 90% confidence intervals (CIs) of the natural log-transformed values were within the predetermined 80-125% equivalence range for the maximum plasma drug concentration (Cmax) and the area under the plasma concentration-time curve (AUC), in accordance with guidelines issued by the US Food and Drug Administration. Assessment of tolerability was based on recording of adverse events (AEs), monitoring of vital signs, electrocardiograms, and laboratory tests at baseline

  9. Two-way crossover comparison of insulin glargine and insulin detemir in basal-bolus therapy using continuous glucose monitoring

    Directory of Open Access Journals (Sweden)

    Abe S

    2011-07-01

    Full Text Available Shinya Abe1,2, Gaku Inoue1,2, Satoru Yamada1,3, Junichiro Irie1,3, Hiroyuki Nojima2, Kaoru Tsuyusaki2, Kensuke Usui2, Koichiro Atsuda2, Toshikazu Yamanouchi41Diabetes Center, Kitasato Institute Hospital, 2Center for Clinical Pharmacy and Clinical Sciences, Kitasato University, 3Department of Internal Medicine, Keio University School of Medicine, 4Department of Internal Medicine, University of Teikyo School of Medicine, Tokyo, JapanObjective: This study aimed to compare the glucose-lowering effect and glycemic variability of insulin glargine with those of insulin detemir.Material and methods: This was an open-label, single-center, randomized, two-way crossover study in patients with diabetes on basal-bolus insulin therapy, with neutral protamine Hagedorn (NPH insulin as basal insulin. Patients switched from NPH insulin to a course either of insulin glargine followed by insulin detemir, or insulin detemir followed by insulin glargine, continuing the same dose of the prior bolus of insulin. To evaluate the glucose-lowering effect, daily glycemic profiles were recorded for 72 hours by continuous glucose monitoring (CGM in an outpatient setting. The mean amplitude of glycemic excursions, standard deviation (SD, and the mean of daily difference (MODD were used to assess intraday and day-to-day glycemic variability.Results: Eleven patients were enrolled and nine completed the study. Mean blood glucose calculated from CGM values was significantly lower with insulin glargine compared with insulin detemir (9.6 ± 2.4 mmol/L versus 10.4 ± 2.8 mmol/L, P = 0.038. The SD was significantly lower with insulin glargine versus insulin detemir (2.5 ± 0.9 mmol/L vs 3.5 ± 1.6 mmol/L, P = 0.011. The MODD value was significantly lower with insulin glargine than with insulin detemir (2.2 ± 1.1 mmol/L vs 3.6 ± 1.7 mmol/L, P = 0.011. There was no significant difference between the two insulin analogs in terms of hypoglycemia.Conclusion: This study suggests that

  10. Comparison of the effect of a single dose of omeprazole or lansoprazole on intragastric pH in Japanese participants: a two-way crossover study.

    Science.gov (United States)

    Funaki, Yasushi; Tokudome, Kentaro; Izawa, Shinya; Tamura, Yasuhiro; Kondo, Yoshihiro; Iida, Akihito; Mizuno, Mari; Ogasawara, Naotaka; Sasaki, Makoto; Kasugai, Kunio

    2013-03-01

    It is known that the pharmacokinetic profile of proton pump inhibitors (PPIs) after postprandial administration may differ among PPIs. The purpose of this study was to compare the inhibitory effects of gastric acid secretion by PPIs administered after a meal, based on a 24-hour intragastric pH monitoring. Ten healthy men who provided written informed consent participated in the study. They were given a 20-mg omeprazole tablet and a 30-mg lansoprazole orally dispersing tablet in a two-way crossover manner. At baseline, the anti-HP-IgG antibody levels in blood and the pepsinogen (PG) I/II ratio were measured. Participants were given a standardized meal and 200 mL of water at 9:30 am, 13:30 pm, and 18.30 pm. Participants took the PPI after breakfast. Two of the ten participants tested positive for Helicobacter pylori infection. The PG I/II ratio indicated negative gastric atrophy in all the participants. The percentage 24-hour intragastric pH > 4 holding times (median, range) with omeprazole and lansoprazole were 29.3, 19.3-50.0% and 27.8, 13.0-42.3%, respectively, which shows that with the administration of omeprazole, the pH was maintained at >4 for a longer period (p lansoprazole (p lansoprazole, a single postprandial dose of omeprazole showed a more rapid and sustained acid-inhibitory effect. Copyright © 2012. Published by Elsevier B.V.

  11. A two-way enriched clinical trial design: combining advantages of placebo lead-in and randomized withdrawal.

    Science.gov (United States)

    Ivanova, Anastasia; Tamura, Roy N

    2015-12-01

    A new clinical trial design, designated the two-way enriched design (TED), is introduced, which augments the standard randomized placebo-controlled trial with second-stage enrichment designs in placebo non-responders and drug responders. The trial is run in two stages. In the first stage, patients are randomized between drug and placebo. In the second stage, placebo non-responders are re-randomized between drug and placebo and drug responders are re-randomized between drug and placebo. All first-stage data, and second-stage data from first-stage placebo non-responders and first-stage drug responders, are utilized in the efficacy analysis. The authors developed one, two and three degrees of freedom score tests for treatment effect in the TED and give formulae for asymptotic power and for sample size computations. The authors compute the optimal allocation ratio between drug and placebo in the first stage for the TED and compare the operating characteristics of the design to the standard parallel clinical trial, placebo lead-in and randomized withdrawal designs. Two motivating examples from different disease areas are presented to illustrate the possible design considerations. © The Author(s) 2011.

  12. 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 C max , AUC 0-5 , AUC 5-last , and AUC inf were calculated to determine bioequivalence. Safety was monitored throughout the study. The 90% confidence intervals (CIs) for the log-transformed C max , AUC 0-5 , AUC 5-last , and AUC inf 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.

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

    Science.gov (United States)

    Clarebrough, E; Guest, G; Stupart, D

    2015-12-01

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

  14. Texting improves testing: a randomized trial of two-way SMS to increase postpartum prevention of mother-to-child transmission retention and infant HIV testing.

    Science.gov (United States)

    Odeny, Thomas A; Bukusi, Elizabeth A; Cohen, Craig R; Yuhas, Krista; Camlin, Carol S; McClelland, R Scott

    2014-09-24

    Many sub-Saharan African countries report high postpartum loss to follow-up of mother-baby pairs. We aimed to determine whether interactive text messages improved rates of clinic attendance and early infant HIV testing in the Nyanza region of Kenya. Parallel-group, unblinded, randomized controlled trial. HIV-positive pregnant women at least 18 years old and enrolled in the prevention of mother-to-child transmission of HIV programme were randomized to receive either text messages (SMS group, n = 195) or usual care (n = 193). Messages were developed using formative focus group research informed by constructs of the Health Belief Model. The SMS group received up to eight text messages before delivery (depending on gestational age), and six messages postpartum. Primary outcomes included maternal postpartum clinic attendance and virological infant HIV testing by 8 weeks postpartum. The primary analyses were intention-to-treat. Of the 388 enrolled women, 381 (98.2%) had final outcome information. In the SMS group, 38 of 194 (19.6%) women attended a maternal postpartum clinic compared to 22 of 187 (11.8%) in the control group (relative risk 1.66, 95% confidence interval 1.02-2.70). HIV testing within 8 weeks was performed in 172 of 187 (92.0%) infants in the SMS group compared to 154 of 181 (85.1%) in the control group (relative risk 1.08, 95% confidence interval 1.00-1.16). Text messaging significantly improved maternal postpartum visit attendance, but overall return rates for these visits remained low. In contrast, high rates of early infant HIV testing were achieved in both arms, with significantly higher testing rates in the SMS compared to the control infants.

  15. The crossover from random close to random loose packings of frictional disks

    Science.gov (United States)

    Papanikolaou, Stefanos

    2013-03-01

    Mechanically stable packings of frictionless disks with contact interactions form through fast quenches at random close packing (RCP). However, for frictional particles with static friction coefficient μ greater than μ*, the packing density slides toward random loose packing (RLP) at large friction. We elucidate the crossover from random close to random loose packing through simulations of bidisperse disks using the geometric asperity (GA) and Cundall-Strack (CS) friction models. We demonstrate that a change takes place in the structure of allowed mechanically stable packings in configuration space: From uncorrelated points at zero friction to linear and other low-dimensional structures at small friction to higher dimensional structures at large friction. Further, we use the GA model to study dynamical mechanical properties without ad hoc assumptions for sliding contacts, and we find that low-frequency vibrational modes with significant rotational content display a strong peak below μ*. Their rotational content drastically changes from co-rotating contacting particles for low friction to counter-rotating, gear-like, for μ greater than μ* and the groups of particles with gear-like dynamical contributions percolate at μ*. Finally, the very existence of the low-frequency vibrational peak gives rise to a change in the scaling of the static shear modulus with pressure compared to the frictionless behavior. DTRA Grant No. 1-10-1-0021

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

    Science.gov (United States)

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

    2004-01-01

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

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

    DEFF Research Database (Denmark)

    Nielsen, Jimmi; Thode, Dorrit; Stenager, Elsebeth

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

  18. 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

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

    NARCIS (Netherlands)

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

    2013-01-01

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

  20. 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)

  1. 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.

  2. Methylphenidate significantly improves driving performance of adults with attention-deficit hyperactivity disorder: a randomized crossover trial.

    NARCIS (Netherlands)

    Verster, J.C.; Bekker, E.M.; Roos, M.; Minova, A.; Eijken, E.J.; Kooij, J.J.S.; Buitelaar, J.K.; Kenemans, J.L.; Verbaten, M.N.; Olivier, B.; Volkerts, E.R.

    2008-01-01

    Although patients with attention-deficit hyperactivity disorder (ADHD) have reported improved driving performance on methylphenidate, limited evidence exists to support an effect of treatment on driving performance and some regions prohibit driving on methylphenidate. A randomized, crossover trial

  3. 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.

  4. Timing of food intake impacts daily rhythms of human salivary microbiota: a randomized, crossover study.

    Science.gov (United States)

    Collado, María Carmen; Engen, Phillip A; Bandín, Cristina; Cabrera-Rubio, Raúl; Voigt, Robin M; Green, Stefan J; Naqib, Ankur; Keshavarzian, Ali; Scheer, Frank A J L; Garaulet, Marta

    2018-01-05

    The composition of the diet (what we eat) has been widely related to the microbiota profile. However, whether the timing of food consumption (when we eat) influences microbiota in humans is unknown. A randomized, crossover study was performed in 10 healthy normal-weight young women to test the effect of the timing of food intake on the human microbiota in the saliva and fecal samples. More specifically, to determine whether eating late alters daily rhythms of human salivary microbiota, we interrogated salivary microbiota in samples obtained at 4 specific time points over 24 h, to achieve a better understanding of the relationship between food timing and metabolic alterations in humans. Results revealed significant diurnal rhythms in salivary diversity and bacterial relative abundance ( i.e., TM7 and Fusobacteria) across both early and late eating conditions. More importantly, meal timing affected diurnal rhythms in diversity of salivary microbiota toward an inverted rhythm between the eating conditions, and eating late increased the number of putative proinflammatory taxa, showing a diurnal rhythm in the saliva. In a randomized, crossover study, we showed for the first time the impact of the timing of food intake on human salivary microbiota. Eating the main meal late inverts the daily rhythm of salivary microbiota diversity which may have a deleterious effect on the metabolism of the host.-Collado, M. C., Engen, P. A., Bandín, C., Cabrera-Rubio, R., Voigt, R. M., Green, S. J., Naqib, A., Keshavarzian, A., Scheer, F. A. J. L., Garaulet, M. Timing of food intake impacts daily rhythms of human salivary microbiota: a randomized, crossover study.

  5. Chest Compression With Personal Protective Equipment During Cardiopulmonary Resuscitation: A Randomized Crossover Simulation Study.

    Science.gov (United States)

    Chen, Jie; Lu, Kai-Zhi; Yi, Bin; Chen, Yan

    2016-04-01

    Following a chemical, biological, radiation, and nuclear incident, prompt cardiopulmonary resuscitation (CPR) procedure is essential for patients who suffer cardiac arrest. But CPR when wearing personal protection equipment (PPE) before decontamination becomes a challenge for healthcare workers (HCW). Although previous studies have assessed the impact of PPE on airway management, there is little research available regarding the quality of chest compression (CC) when wearing PPE.A present randomized cross-over simulation study was designed to evaluate the effect of PPE on CC performance using mannequins.The study was set in one university medical center in the China.Forty anesthesia residents participated in this randomized cross-over study.Each participant performed 2 min of CC on a manikin with and without PPE, respectively. Participants were randomized into 2 groups that either performed CC with PPE first, followed by a trial without PPE after a 180-min rest, or vice versa.CPR recording technology was used to objectively quantify the quality of CC. Additionally, participants' physiological parameters and subjective fatigue score values were recorded.With the use of PPE, a significant decrease of the percentage of effective compressions (41.3 ± 17.1% with PPE vs 67.5 ± 15.6% without PPE, P disadvantage for enhancing survival of cardiac arrest.

  6. A randomized crossover trial of tenoxicam compared with rofecoxib for postoperative dental pain control.

    Science.gov (United States)

    Zacharias, M; De Silva, R K; Herbison, P; Templer, P

    2004-12-01

    Two non-steroidal anti-inflammatory drugs, tenoxicam and rofecoxib, were compared for the control of postoperative pain following surgical extraction of bilaterally and symmetrically impacted wisdom teeth performed under intravenous sedation and local anaesthesia. Thirty-five young fit adult patients received each analgesic treatment for four days in a randomized, crossover design. The results suggest statistically better pain relief for the selective COX-2 inhibitor rofecoxib compared to tenoxicam, a traditional NSAID. There were side-effects with both treatments. Abdominal discomfort was significantly more common following rofecoxib compared to tenoxicam. Both analgesics were acceptable to most participants in the trial.

  7. A random matrix approach to the crossover of energy-level statistics from Wigner to Poisson

    International Nuclear Information System (INIS)

    Datta, Nilanjana; Kunz, Herve

    2004-01-01

    We analyze a class of parametrized random matrix models, introduced by Rosenzweig and Porter, which is expected to describe the energy level statistics of quantum systems whose classical dynamics varies from regular to chaotic as a function of a parameter. We compute the generating function for the correlations of energy levels, in the limit of infinite matrix size. The crossover between Poisson and Wigner statistics is measured by a renormalized coupling constant. The model is exactly solved in the sense that, in the limit of infinite matrix size, the energy-level correlation functions and their generating function are given in terms of a finite set of integrals

  8. Band bowing and the direct-to-indirect crossover in random BAlN alloys

    Science.gov (United States)

    Shen, Jimmy-Xuan; Wickramaratne, Darshana; Van de Walle, Chris G.

    2017-11-01

    Boron-containing nitride alloys such as BAlN are being explored as novel members of the nitride family of materials for electronic and optoelectronic applications. Using hybrid density functional calculations we determine structural properties, band gaps, and band-gap bowing of random wurtzite BAlN alloys. The fundamental band gap of BN is indirect while AlN is a direct-band-gap semiconductor. This leads to a crossover in the band gap from direct to indirect at 28 % boron. We find that the direct band gap experiences extreme bowing, leading to a fundamental gap that changes very little up to 17% boron incorporation.

  9. 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 the STN and GPi of 12 patients with focal, multifocal, or generalized dystonia. Each patient was randomly selected to undergo initial bilateral stimulation of either the STN or the GPi for 6 months, followed by bilateral stimulation of the other nucleus for another 6 months. Preoperative and postoperative...

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

    Science.gov (United States)

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

    2015-01-01

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

  11. 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.

  12. Improvement in chest compression quality using a feedback device (CPRmeter): a simulation randomized crossover study.

    Science.gov (United States)

    Buléon, Clément; Parienti, Jean-Jacques; Halbout, Laurent; Arrot, Xavier; De Facq Régent, Hélène; Chelarescu, Dan; Fellahi, Jean-Luc; Gérard, Jean-Louis; Hanouz, Jean-Luc

    2013-10-01

    Cardiac arrest survival depends on celerity and efficiency of life support action. Guidelines emphasized the chest compression (CC) quality and feedback devices are encouraged. The purpose is to study the impact of the CPRmeter feedback device on resuscitation performed by untrained rescuers. This is a prospective randomized crossover study on manikins (Resusci Anne). One hundred and forty four students inexperienced in cardiopulmonary resuscitation representing untrained rescuers were included. Participants performed 2 minutes of CC without interruption with (group G) or without (group B) feedback. Four months passed between the 2 crossover phases to avoid resilience effect. Data collected by the CPRmeter device were: CC rate, depth and release. Efficient CC rate ([simultaneous and correct CC rate, depth and release] primary outcome) (absolute difference [95% CI]) was significantly improved in group G (71%) compared to group B (26%; [45 {36-55}]; P 38 mm) was significantly improved in group G (85%) compared to group B (43%; [42 {33-52}]; P < .0001). Adequate CC rate (90-120/min) was significantly improved in group G (81%) compared to group B (56%; [25 {15-35}]; P < .0001). The average CC rate and depth in group G were significantly less dispersed around the mean compared to group B (test of variance P < .007; P < .015 respectively). The use of the CPRmeter significantly improved CC quality performed by students inexperienced in cardiopulmonary resuscitation. © 2013.

  13. Effectiveness of electric toothbrushing in patients with neuromuscular disability: A randomized observer-blind crossover trial.

    Science.gov (United States)

    Ikeda, Tokuhei; Yoshizawa, Kunio; Takahashi, Kazuya; Ishida, Chiho; Komai, Kiyonobu; Kobayashi, Kazuhiko; Sugiura, Shirou

    2016-01-01

    To evaluate the effectiveness of an electric toothbrush for oral care in patients with neuromuscular disability. In this randomized observer-blind crossover trial, 30 patients with neuromuscular disease performed either electric or manual toothbrushing each for 4 weeks. Plaque status (plaque control record), periodontal pocket depth, oral status (oral assessment guide), salivary bacterial count, and toothbrushing time were assessed after each period and compared between the two groups by Wilcoxon signed-rank test. Twenty-eight patients completed the study, including 18 communicative patients. Periodontal pockets were significantly shallower and toothbrushing time was significantly shorter with electric toothbrush use than with manual toothbrush use. No significant differences in oral status and salivary bacterial counts were noted between the approaches, but plaque status significantly improved after electric toothbrushing in communicative patients. Electric toothbrushing is beneficial for maintaining oral health in patients with neuromuscular disability and reducing the caregivers' oral care burden. © 2015 Special Care Dentistry Association and Wiley Periodicals, Inc.

  14. Explicit Bias Toward High-Income-Country Research: A Randomized, Blinded, Crossover Experiment Of English Clinicians.

    Science.gov (United States)

    Harris, Matthew; Marti, Joachim; Watt, Hillary; Bhatti, Yasser; Macinko, James; Darzi, Ara W

    2017-11-01

    Unconscious bias may interfere with the interpretation of research from some settings, particularly from lower-income countries. Most studies of this phenomenon have relied on indirect outcomes such as article citation counts and publication rates; few have addressed or proven the effect of unconscious bias in evidence interpretation. In this randomized, blinded crossover experiment in a sample of 347 English clinicians, we demonstrate that changing the source of a research abstract from a low- to a high-income country significantly improves how it is viewed, all else being equal. Using fixed-effects models, we measured differences in ratings for strength of evidence, relevance, and likelihood of referral to a peer. Having a high-income-country source had a significant overall impact on respondents' ratings of relevance and recommendation to a peer. Unconscious bias can have far-reaching implications for the diffusion of knowledge and innovations from low-income countries.

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

    DEFF Research Database (Denmark)

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

    2008-01-01

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

  16. Technology transfer, a two-way street

    International Nuclear Information System (INIS)

    Martin, H.L.

    1994-01-01

    Technology transfer through the Pollution Prevention ampersand Control Conferences, which have been cosponsored by the Environmental Protection Agency and by the professional societies of industry, greatly improved the environmental projects of the Department of Energy at Savannah River Site (SRS) in the mid-1980's. Those technologies, used in the liquid effluent treatment of the metal finishing liquid effluents from aluminum cleaning and nickel plating of fuel and targets for the nuclear production reactors, have been enhanced by the research and development of SRS engineers and scientists. The technology transfer has now become a two-way street to the benefit of our Nation's environment as these enhancements are being adopted in the metal finishing industry. These success stories are examples of the achievements anticipated in the 1990's as technology development in the federal facilities is shared with commercial industry

  17. Crossover versus Stabilometric Platform for the Treatment of Balance Dysfunction in Parkinson’s Disease: A Randomized Study

    Directory of Open Access Journals (Sweden)

    G. Frazzitta

    2015-01-01

    Full Text Available Balance dysfunctions are a major challenge in the treatment of Parkinson’s disease (PD. Previous studies have shown that rehabilitation can play a role in their treatment. In this study, we have compared the efficacy of two different devices for balance training: stabilometric platform and crossover. We have enrolled 60 PD patients randomly assigned to two groups. The first one (stabilometric group performed a 4-week cycle of balance training, using the stabilometric platform, whereas the second one (crossover group performed a 4-week cycle of balance training, using the crossover. The outcome measures used were Unified Parkinson’s Disease Rating Scale (UPDRS part II, Berg Balance Scale (BBS, Timed Up and Go (TUG, and Six Minutes Walking Test (6MWT. Results showed that TUG, BBS, and UPDRS II improved in both groups. There was not difference in the efficacy of the two balance treatments. Patients in both groups improved also the meters walked in the 6MWT at the end of rehabilitation, but the improvement was better for patients performing crossover training. Our results show that the crossover and the stabilometric platform have the same effect on balance dysfunction of Parkinsonian patients, while crossover gets better results on the walking capacity.

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

    Science.gov (United States)

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

  19. 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

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

    DEFF Research Database (Denmark)

    Lindelof, K; Bendtsen, L; Lindelof, K

    2009-01-01

    Treatment for chronic tension-type headache (CTTH) is unsatisfactory. Our aim was to investigate the efficacy of the N-methyl D-aspartate (NMDA) antagonist memantine in the prophylactic treatment of CTTH. We included 40 patients in a randomized, double-blind, placebo-controlled, crossover trial...

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

    DEFF Research Database (Denmark)

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

    2011-01-01

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

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

    Science.gov (United States)

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

    2012-01-01

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

  3. A Prospective Randomized Crossover Study on the Comparison of Cotton Versus Waterproof Cast Liners

    Science.gov (United States)

    Guillen, Philip T.; Fuller, Corey B.; Riedel, Barth B.; Wongworawat, Montri D.

    2016-01-01

    Background: Many fractures are treated with casting which can cause complications likely from inability to wash the extremity. Gore-Tex-based waterproof cast liner has been compared with cotton liner and shown to be superior in physician and patient scoring but also has high cost and difficult application. The purpose of this study is to compare newer generation waterproof liners with traditional cotton liner. It is the first study to compare this new waterproof liner and cotton liner in a crossover model, allowing patients to swim in the pool with the cast. Methods: Twenty patients (ages 3-30) with upper extremity injuries were randomized to waterproof-liner or cotton-liner casts made of fiberglass. Patients would switch cast liners halfway between their treatments to fulfill crossover criteria. All fractures were within a 2-week period from original incident. At each clinic visit, patients evaluated comfort parameters through questionnaires, and physicians rated skin condition. Patients were also asked which cast liner they preferred at the end of the study. Results: There were no unscheduled cast changes. The waterproof-liner group had better scores for odor (P = .041), sweat (P = .016), and overall physician-rated score (P = .038). There was no significant difference in other patient-rated parameters. Seventy-five percent of patients preferred waterproof casting to the cotton liner. Conclusions: This new waterproof cast liner, compared with cotton cast liner, had better odor, sweat, and overall physician scores. The waterproof liners allow patients to rinse casts daily, and the majority of patients prefer waterproof to cotton liner. PMID:27418889

  4. Piroxicam immediate release formulations: A fasting randomized open-label crossover bioequivalence study in healthy volunteers.

    Science.gov (United States)

    Helmy, Sally A; El-Bedaiwy, Heba M

    2014-11-01

    Piroxicam is a NSAID with analgesic and antipyretic properties, used for the treatment of rheumatoid diseases. The aim of this study was to evaluate the bioequivalence of two brands of piroxicam capsules (20 mg) in 24 Egyptian volunteers. The in vivo study was established according to a single-center, randomized, single-dose, laboratory-blinded, 2-period, 2-sequence, crossover study with a washout period of 3 weeks. Under fasting conditions, 24 healthy male volunteers were randomly selected to receive a single oral dose of one capsule (20 mg) of either test or reference product. Plasma samples were obtained over a 144-hour interval and analyzed for piroxicam by HPLC with UV detection. The pharmacokinetic parameters Cmax , tmax , AUC0-t , AUC0-∞ , Vd /F, Cl/F, and t1/2 were determined from plasma concentration-time profiles. The 90% confidence intervals for the ratio of log transformed values of Cmax , AUC0-t , and AUC0-∞ of the two treatments were within the acceptable range (0.8-1.25) for bioequivalence. From PK perspectives, the two piroxicam formulations were considered bioequivalent, based on the rate and extent of absorption. No adverse events occurred or were reported after a single 20-mg piroxicam and both formulations were well-tolerated. © 2014, The American College of Clinical Pharmacology.

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

    Science.gov (United States)

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

    2013-03-25

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

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

    Science.gov (United States)

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

    2010-01-01

    Purpose Estimates of insomnia in breast cancer patients are high, with reports of poor sleep lasting years after completion of cancer treatment. This randomized controlled crossover pilot study looked at the effects of individual cognitive behavioral therapy for insomnia (IND-CBT-I) on sleep in breast cancer survivors. Patients and methods Twenty-one participants were randomly assigned to either a treatment group (six weekly IND-CBT-I sessions followed by six weeks of follow up) or a delayed treatment control group (no treatment for six weeks followed by six weekly IND-CBT-I sessions). Of these, 14 participants completed the pilot study (six in the treatment group and eight in the delayed treatment control group). Results Self-rated insomnia was significantly improved in the treatment group compared to the waiting period in the delayed treatment control group. The pooled pre-post-IND-CBT-I analyses revealed improvements in self-rated insomnia, sleep quality, and objective measures of sleep. Conclusions These preliminary results suggest that IND-CBT-I is appropriate for improving sleep in breast cancer survivors. Individual therapy in a clinic or private practice may be a more practical option for this population as it is more easily accessed and readily available in an outpatient setting. PMID:23616695

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

    Science.gov (United States)

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

    2016-12-01

    To examine the effect of patient-selected music intervention during daily weaning trials for patients on prolonged mechanical ventilation. Using a crossover repeated measures design, patients were randomized to music vs no music on the first intervention day. Provision of music was alternated for 6 days, resulting in 3 music and 3 no music days. During weaning trials on music days, data were obtained for 30min prior to music listening and continued for 60min while patients listened to selected music (total 90min). On no music days, data were collected for 90min. Outcome measures were heart rate (HR), respiratory rate (RR), oxygen saturation (SpO 2 ), blood pressure (BP), dyspnea and anxiety assessed with a visual analog scale (VAS-D, VAS-A) and weaning duration (meanh per day on music and non-music days). Of 31 patients randomized, 23 completed the 6-day intervention. When comparisons were made between the 3 music and 3 no music days, there were significant decreases in RR and VAS-D and a significant increase in daily weaning duration on music days (pmusic days (pmusic during daily weaning trials is a simple, low-cost, potentially beneficial intervention for patients on prolonged mechanical ventilation. Further study is indicated to test ability of this intervention to promote weaning success and benefits earlier in the weaning process. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

    Science.gov (United States)

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

    2011-01-01

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

  9. The Analysis of Two-Way Functional Data Using Two-Way Regularized Singular Value Decompositions

    KAUST Repository

    Huang, Jianhua Z.

    2009-12-01

    Two-way functional data consist of a data matrix whose row and column domains are both structured, for example, temporally or spatially, as when the data are time series collected at different locations in space. We extend one-way functional principal component analysis (PCA) to two-way functional data by introducing regularization of both left and right singular vectors in the singular value decomposition (SVD) of the data matrix. We focus on a penalization approach and solve the nontrivial problem of constructing proper two-way penalties from oneway regression penalties. We introduce conditional cross-validated smoothing parameter selection whereby left-singular vectors are cross- validated conditional on right-singular vectors, and vice versa. The concept can be realized as part of an alternating optimization algorithm. In addition to the penalization approach, we briefly consider two-way regularization with basis expansion. The proposed methods are illustrated with one simulated and two real data examples. Supplemental materials available online show that several "natural" approaches to penalized SVDs are flawed and explain why so. © 2009 American Statistical Association.

  10. Laboratory- and community-based health outcomes in people with transtibial amputation using crossover and energy-storing prosthetic feet: A randomized crossover trial

    Science.gov (United States)

    Morgan, Sara J.; McDonald, Cody L.; Halsne, Elizabeth G.; Cheever, Sarah M.; Salem, Rana; Kramer, Patricia A.

    2018-01-01

    Contemporary prosthetic feet are generally optimized for either daily or high-level activities. Prosthesis users, therefore, often require multiple prostheses to participate in activities that span a range of mobility. Crossover feet (XF) are designed to increase the range of activities that can be performed with a single prosthesis. However, little evidence exists to guide clinical prescription of XF relative to traditional energy storing feet (ESF). The objective of this study was to assess the effects of XF and ESF on health outcomes in people with transtibial amputation. A randomized crossover study was conducted to assess changes in laboratory-based (endurance, perceived exertion, walking performance) and community-based (step activity and self-reported mobility, fatigue, balance confidence, activity restrictions, and satisfaction) outcomes. Twenty-seven participants were fit with XF and ESF prostheses with standardized sockets, interfaces, and suspensions. Participants were not blinded to the intervention, and wore each prosthesis for one month while their steps were counted with an activity monitor. After each accommodation period, participants returned for data collection. Endurance and perceived exertion were measured with the Six-Minute Walk Test and Borg-CR100, respectively. Walking performance was measured using an electronic walkway. Self-reported mobility, fatigue, balance confidence, activity restrictions, and satisfaction were measured with survey instruments. Participants also reported foot preferences upon conclusion of the study. Differences between feet were assessed with a crossover analysis. While using XF, users experienced improvements in most community-based outcomes, including mobility (p = .001), fatigue (p = .001), balance confidence (p = .005), activity restrictions (p = .002), and functional satisfaction (p Results indicate that XF may be a promising alternative to ESF for people with transtibial amputation who engage in a range of

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

    Science.gov (United States)

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

    2008-07-01

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

  12. Nasal steroids in snorers can decrease snoring frequency: a randomized placebo-controlled crossover trial.

    Science.gov (United States)

    Koutsourelakis, Ioannis; Keliris, Anastasios; Minaritzoglou, Aliki; Zakynthinos, Spyros

    2015-04-01

    Although it is anecdotally known that nasal obstruction is associated with snoring, it remains unknown whether the application of nasal steroids could decrease oral/oro-nasal breathing and increase nasal breathing, and subsequently decrease snoring indices. This study evaluated the effect of nasal budesonide on breathing route pattern and snoring. Twenty-four snorers were enrolled in a randomized, double-blind, crossover trial of 1-week treatment with nasal budesonide compared with 1-week intervention with nasal placebo. At the start and end of each treatment period, patients underwent nasal resistance measurement and overnight polysomnography with concomitant measurement of breathing route pattern and snoring. Twelve patients were randomly assigned to a 1-week treatment with nasal budesonide, followed by 2-week washout period and a 1-week intervention with the nasal placebo; and 12 patients were randomly assigned to a 1-week intervention with nasal placebo, followed by 2-week washout period and a 1-week treatment with nasal budesonide. Nasal budesonide was associated with a decrease in oral/oro-nasal breathing epochs and concomitant increase in nasal breathing epochs, decrease of snoring frequency by [median (interquartile range)] 15.8% (11.2-18.8%), and an increase of rapid eye movement sleep; snoring intensity decreased only in patients with increased baseline nasal resistance by 10.6% (6.8-14.3%). The change in nasal breathing epochs was inversely related to the change in snoring frequency (Rs = 0.503; P snoring frequency and increase rapid eye movement sleep. © 2014 European Sleep Research Society.

  13. ACT Internet-based vs face-to-face? A randomized controlled trial of two ways to deliver Acceptance and Commitment Therapy for depressive symptoms: an 18-month follow-up.

    Science.gov (United States)

    Lappalainen, Päivi; Granlund, Anna; Siltanen, Sari; Ahonen, Suvi; Vitikainen, Minna; Tolvanen, Asko; Lappalainen, Raimo

    2014-10-01

    The aim of the present study was to investigate two interventions based on Acceptance and Commitment Therapy (ACT) for depressive symptoms: A face-to-face treatment (ACT group) was compared to a guided self-help treatment delivered via the Internet consisting of two assessment sessions (pre and post) and an ACT-based Internet program (iACT). Outpatients experiencing at least mild depressive symptoms were randomized to either approach. The iACT treatment group received access to an ACT-based Internet program and supportive web-based contact over a period of 6 weeks. The face-to-face group received ACT-based treatment once a week over the same period of time. In both groups, the results showed a significant effect on depression symptomatology, and general wellbeing after treatment and at the 18-month follow-up. However, the data indicated that the iACT group changed differently regarding depressive symptoms and wellbeing as compared to the face-to face ACT group. Results showed large pre-treatment to 18-month follow-up within-group effect sizes for all symptom measures in the iACT treatment group (1.59-2.08), and for most outcome measures in the face-to-face ACT group (1.12-1.37). This non-inferiority study provides evidence that guided Internet-delivered ACT intervention can be as effective as ACT-based face-to-face treatment for outpatients reporting depressive symptoms, and it may offer some advantages over a face-to-face intervention. Copyright © 2014 Elsevier Ltd. All rights reserved.

  14. Captopril does not Potentiate Post-Exercise Hypotension: A Randomized Crossover Study.

    Science.gov (United States)

    Queiroz, Andréia Cristiane Carrenho; Sousa, Julio Cesar Silva; Silva, Natan Daniel; Tobaldini, Eleonora; Ortega, Katia Coelho; de Oliveira, Edilamar Menezes; Brum, Patricia Chakur; Montano, Nicola; Mion, Decio; Tinucci, Taís; de Moraes Forjaz, Claudia Lucia

    2017-04-01

    To evaluate whether captopril (3×50 mg/day) potentiates post-resistance exercise hypotension (PREH) in hypertensives (HT), 12 HT men received captopril and placebo for 4 weeks each in a double-blinded, randomized-crossover design. On each therapy, subjects underwent 2 sessions: Control (C - rest) and Resistance Exercise (RE - 7 exercises, 3 sets to moderate fatigue, 50% of 1 RM -repetition maximum). Measurements were taken before and after 30-60 min (Post1) and 7 h (Post2), and ambulatory blood pressure (BP) was monitored for 24 h. There were no differences in PREH characteristics and mechanisms between the placebo and captopril periods. At Post1, systolic/diastolic BP decreased significantly and similarly after RE with both therapies (Placebo=-13±2/-9±1 mmHg vs. Captopril=-12±2/-10±1 mmHg, PCaptopril: +13±2 bpm, +35±4 nu, 17±5 ml, -3±1 ms/mmHg, Pcaptopril did not potentiate the magnitude and duration of PREH in HT men, and it did not influence PREH mechanisms. © Georg Thieme Verlag KG Stuttgart · New York.

  15. 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.

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

    Directory of Open Access Journals (Sweden)

    Nirjhar Dutta

    2014-06-01

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

  17. Pursed lip breathing improves exercise tolerance in COPD: a randomized crossover study.

    Science.gov (United States)

    Cabral, L Ferracini; D'Elia, T Da Cunha; Marins, D De Sousa; Zin, W Araujo; Guimarães, F Silva

    2015-02-01

    Although pursed-lip breathing (PLB) has been advocated to reduce respiratory rate and improve oxygen saturation in patients with chronic obstructive pulmonary disease (COPD) at rest, the evidence of its effects on dynamic hyperinflation (DH) and exercise tolerance is scarce. To evaluate the effect of PLB on exercise tolerance, breathing pattern, dynamic hyperinflation and arterial oxygenation in COPD patients during high-intensity exercise. Randomized crossover study. Laboratory of Respiration Physiology, Federal University of Rio de Janeiro. Forty stable COPD patients aged 40-75 years and with FEV1breathing (CB) during constant work-rate exercise in an electrically-braked cycloergometer. Dynamic hyperinflation, oxygen saturation and breathing pattern were recorded at rest, in isotime and in peak exercise. The nine patients who increased their endurance time by more than 25% during PLB (6.42 ± 2.36 vs. 10.51 ± 3.83 min; P breathing pattern in the analyzed subgroups. In COPD patients with low PEF, pursed-lip breathing reduces dynamic hyperinflation and improves exercise tolerance, breathing pattern and arterial oxygenation at submaximal intensity exercise. This study points to a possible application of PLB in a selected group of COPD patients aiming at improving the exercise tolerance. PEF measurements can help to indicate PLB for COPD patients.

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

    Science.gov (United States)

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

    2010-10-01

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

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

    Science.gov (United States)

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

    2016-09-01

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

  20. 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.

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

    Science.gov (United States)

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

    2018-04-01

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

  2. Dietary nitrate reduces resting metabolic rate: a randomized, crossover study in humans.

    Science.gov (United States)

    Larsen, Filip J; Schiffer, Tomas A; Ekblom, Björn; Mattsson, Mathias P; Checa, Antonio; Wheelock, Craig E; Nyström, Thomas; Lundberg, Jon O; Weitzberg, Eddie

    2014-04-01

    Nitrate, which is an inorganic anion abundant in vegetables, increases the efficiency of isolated human mitochondria. Such an effect might be reflected in changes in the resting metabolic rate (RMR) and formation of reactive oxygen species. The bioactivation of nitrate involves its active accumulation in saliva followed by a sequential reduction to nitrite, nitric oxide, and other reactive nitrogen species. We studied effects of inorganic nitrate, in amounts that represented a diet rich in vegetables, on the RMR in healthy volunteers. In a randomized, double-blind, crossover study, we measured the RMR by using indirect calorimetry in 13 healthy volunteers after a 3-d dietary intervention with sodium nitrate (NaNO₃) or a placebo (NaCl). The nitrate dose (0.1 mmol · kg⁻¹ · d⁻¹) corresponded to the amount in 200-300 g spinach, beetroot, lettuce, or other vegetable that was rich in nitrate. Effects of direct nitrite exposure on cell respiration were studied in cultured human primary myotubes. The RMR was 4.2% lower after nitrate compared with placebo administration, and the change correlated strongly to the degree of nitrate accumulation in saliva (r² = 0.71). The thyroid hormone status, insulin sensitivity, glucose uptake, plasma concentration of isoprostanes, and total antioxidant capacity were unaffected by nitrate. The administration of nitrite to human primary myotubes acutely inhibited respiration. Dietary inorganic nitrate reduces the RMR. This effect may have implications for the regulation of metabolic function in health and disease.

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

    Science.gov (United States)

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

    2016-01-01

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

  4. Acupuncture for Pain in Chronic Pancreatitis: A Single-Blinded Randomized Crossover Trial.

    Science.gov (United States)

    Juel, Jacob; Liguori, Stefano; Liguori, Aldo; Poulsen, Jakob L; Valeriani, Massimiliano; Graversen, Carina; Olesen, Søren S; Drewes, Asbjørn M

    2017-02-01

    Many patients with painful chronic pancreatitis (CP) have insufficient effect of treatment, and the prevalence of adverse effects is high. Consequently, alternatives to conventional management are needed. We aimed to study the effect of acupuncture in painful CP. This was a prospective, single-blinded, randomized crossover trial. Fifteen patients with CP were assigned to a session of acupuncture followed by sham stimulation or vice versa. Patients rated clinical pain scores daily on a 0 to 10 visual analogue scale (VAS) and completed the Patient Global Impression of Change. For mechanistic linkage, resting state electroencephalograms were recorded and quantified by spectral power analysis to explore effects on central pain processing. Acupuncture, compared with sham stimulation, caused more pain relief (2.0 ± 1.5 VAS vs 0.7 ± 0.8 VAS; P = 0.009). The effect, however, was short, and after 1-week follow-up, there was no difference in clinical pain scores between groups (P = 1.0) or the rating of Patient Global Impression of Change (P = 0.8). Electroencephalogram spectral power distributions between sham and acupuncture were comparable between groups (all P > 0.6). The study presents proof-of-concept for the analgesic effect of acupuncture in pancreatic pain. Although the effect was short lasting, the framework may be used to conceptualize future trials of acupuncture in visceral pain.

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

    Directory of Open Access Journals (Sweden)

    Jeronimo M Oliveira-Neto

    2013-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Caleigh M. Sawicki

    2016-12-01

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

  7. Effects of evening vs morning levothyroxine intake: a randomized double-blind crossover trial.

    Science.gov (United States)

    Bolk, Nienke; Visser, Theo J; Nijman, Judy; Jongste, Ineke J; Tijssen, Jan G P; Berghout, Arie

    2010-12-13

    Levothyroxine sodium is widely prescribed to treat primary hypothyroidism. There is consensus that levothyroxine should be taken in the morning on an empty stomach. A pilot study showed that levothyroxine intake at bedtime significantly decreased thyrotropin levels and increased free thyroxine and total triiodothyronine levels. To date, no large randomized trial investigating the best time of levothyroxine intake, including quality-of-life evaluation, has been performed. To ascertain if levothyroxine intake at bedtime instead of in the morning improves thyroid hormone levels, a randomized double-blind crossover trial was performed between April 1, 2007, and November 30, 2008, among 105 consecutive patients with primary hypothyroidism at Maasstad Hospital Rotterdam in the Netherlands. Patients were instructed during 6 months to take 1 capsule in the morning and 1 capsule at bedtime (one containing levothyroxine and the other a placebo), with a switch after 3 months. Primary outcome measures were thyroid hormone levels; secondary outcome measures were creatinine and lipid levels, body mass index, heart rate, and quality of life. Ninety patients completed the trial and were available for analysis. Compared with morning intake, direct treatment effects when levothyroxine was taken at bedtime were a decrease in thyrotropin level of 1.25 mIU/L (95% confidence interval [CI], 0.60-1.89 mIU/L; P levothyroxine. Levothyroxine taken at bedtime significantly improved thyroid hormone levels. Quality-of-life variables and plasma lipid levels showed no significant changes with bedtime vs morning intake. Clinicians should consider prescribing levothyroxine intake at bedtime. isrctn.org Identifier: ISRCTN17436693 (NTR959).

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

    Science.gov (United States)

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

    2016-02-01

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

  9. 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.

  10. Intravenous immunoglobulin for hypogammaglobulinemia after lung transplantation: a randomized crossover trial.

    Directory of Open Access Journals (Sweden)

    David J Lederer

    Full Text Available We aimed to determine the effects of treatment with intravenous immunoglobulin on bacterial infections in patients with hypogammaglobulinemia (HGG after lung transplantation.We performed a randomized, double-blind, placebo-controlled two-period crossover trial of immune globulin intravenous (IVIG, 10% Purified (Gamunex, Bayer, Elkhart, IN monthly in eleven adults who had undergone lung transplantation more than three months previously. We randomized study participants to three doses of IVIG (or 0.1% albumin solution (placebo given four weeks apart followed by a twelve week washout and then three doses of placebo (or IVIG. The primary outcome was the number of bacterial infections within each treatment period.IVIG had no effect on the number of bacterial infections during the treatment period (3 during IVIG and 1 during placebo; odds ratio 3.5, 95% confidence interval 0.4 to 27.6, p = 0.24. There were no effects on other infections, use of antibiotics, or lung function. IVIG significantly increased trough IgG levels at all time points (least square means, 765.3 mg/dl during IVIG and 486.3 mg/dl during placebo, p<0.001. Four serious adverse events (resulting in hospitalization occurred during the treatment periods (3 during active treatment and 1 during the placebo period, p = 0.37. Chills, flushing, and nausea occurred during one infusion of IVIG.Treatment with IVIG did not reduce the short-term risk of bacterial infection in patients with HGG after lung transplantation. The clinical efficacy of immunoglobulin supplementation in HGG related to lung transplantation over the long term or with recurrent infections is unknown.Clinicaltrials.gov NCT00115778.

  11. Baru almond improves lipid profile in mildly hypercholesterolemic subjects: a randomized, controlled, crossover study.

    Science.gov (United States)

    Bento, A P N; Cominetti, C; Simões Filho, A; Naves, M M V

    2014-12-01

    The usual consumption of nuts reduces cardiovascular diseases (CVD) risk by improving serum lipids and oxidation status. Baru almonds (Dipteryxalata Vog.), a native species of Brazilian Savannah, have considerable contents of monounsaturated fatty acids (MUFA), dietary fiber, vitamin E and zinc, which could exert positive effects in serum lipids and markers of oxidation. However, there is no study about the effect of their consumption on human health. Thus, the aim of this study was to evaluate the effect of baru almonds supplementation on lipid profile and oxidation of mildly hypercholesterolemic subjects. A randomized, crossover, placebo controlled study was performed with 20 mildly hypercholesterolemic subjects (total cholesterol (TC) mean ±SEM = 5.8 ± 0.2 mmol/L). The assay had 2 periods of 6 weeks each and a 4-week washout period between the treatments. Subjects were randomly allocated in alternated periods receiving the following treatments per period: supplementation with 20 g/day of baru almonds or placebo (1 corn starch capsule/day). Compared to placebo, supplementation of baru almonds reduced TC (-8.1 ± 2.4%, P = 0.007), low-density lipoprotein cholesterol (LDL-c) (-9.4 ± 2.4%, P = 0.006) and non-high-density lipoprotein cholesterol (non-HDL-c) (-8.1 ± 3.0%, P = 0.013). There were no significant changes on the oxidation biomarkers evaluated. Dietary supplementation of mildly hypercholesterolemic subjects with baru almonds improved serum lipid parameters, so that this food might be included in diets for reducing the CVD risk. Brazilian Registry of Clinical Trials (ReBEC) (website: http://www.ensaiosclinicos.gov.br). Register number: RBR-4zdy9p. Copyright © 2014 Elsevier B.V. All rights reserved.

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

    Science.gov (United States)

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

    2017-12-01

    Background: In a simulated gastrointestinal environment, the cheese matrix modulates dairy fat digestion. However, to our knowledge, the impact of the cheese matrix on postprandial lipemia in humans has not yet been evaluated. Objective: In healthy subjects, we compared the impact of dairy fat provided from firm cheese, soft cream cheese, and butter on the postprandial response at 4 h and on the incremental area under the curve (iAUC) of plasma triglycerides. Design: Forty-three healthy subjects were recruited to this randomized, crossover, controlled trial. In random order at intervals of 14 d and after a 12-h fast, subjects ingested 33 g fat from a firm cheese (young cheddar), a soft cream cheese (cream cheese), or butter (control) incorporated into standardized meals that were matched for macronutrient content. Plasma concentrations of triglycerides were measured immediately before the meal and 2, 4, 6, and 8 h after the meal. Results: Cheddar cheese, cream cheese, and butter induced similar increases in triglyceride concentrations at 4 h (change from baseline: +59%, +59%, and +62%, respectively; P = 0.9). No difference in the triglyceride iAUC 0-8 h ( P -meal = 0.9) was observed between the 3 meals. However, at 2 h, the triglyceride response caused by the cream cheese (change from baseline: +44%) was significantly greater than that induced by butter (change from baseline: +24%; P = 0.002) and cheddar cheese (change from baseline: +16%; P = 0.0004). At 6 h, the triglyceride response induced by cream cheese was significantly attenuated compared with that induced by cheddar cheese (change from baseline: +14% compared with +42%; P = 0.0004). Conclusion: This study demonstrates that the cheese matrix modulates the impact of dairy fat on postprandial lipemia in healthy subjects. This trial was registered at clinicaltrials.gov as NCT02623790. © 2017 American Society for Nutrition.

  13. Randomized Crossover Study of Training Benefits of High Fidelity ECMO Simulation versus Porcine Animal Model An Interim Report

    Science.gov (United States)

    2017-02-25

    High- Fidelity ECMO Simulation versus Porcine Animal Model - An Interim Report presented at/published to ECMO and the Advanced Therapies for...event. If the sponsor of a conference or meeting is a non-DoD commercial entity or an entity seeking to do business with the government, then your...approval.) Randomized Crossover Study of Training Benefits of High-Fidelity ECMO Simulation versus Porcine Animal Model 6. TITLE OF MATERIAL TO BE

  14. Systemic ropivacaine diminishes pain sensitization processes: a randomized, double-blinded, placebo-controlled, crossover study in healthy volunteers

    OpenAIRE

    Haller, Yéri; Gantenbein, Andreas R; Willimann, Patrick; Spahn, Donat R; Maurer, Konrad

    2014-01-01

    Introduction Ropivacaine is a local anesthetic widely used for regional anesthesia. One of its advantages is low toxicity at plasma concentrations reached systemically during continuous peripheral or central nervous block. The objective of this study was to test the effect of systemic ropivacaine on pain, hyperalgesia, dynamic allodynia, and flare response. Methods This randomized, double-blinded, placebo-controlled, crossover study was carried out in at the Clinical Trials Centre, University...

  15. Psyllium Supplementation in Adolescents Improves Fat Distribution & Lipid Profile: A Randomized, Participant-Blinded, Placebo-Controlled, Crossover Trial

    OpenAIRE

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

    2012-01-01

    AIMS: We aimed to assess the effects of psyllium supplementation on insulin sensitivity and other parameters of the metabolic syndrome in an at risk adolescent population. METHODS: This study encompassed a participant-blinded, randomized, placebo-controlled, crossover trial. Subjects were 47 healthy adolescent males aged 15-16 years, recruited from secondary schools in lower socio-economic areas with high rates of obesity. Participants received 6 g/day of psyllium or placebo for 6 weeks, with...

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

    Science.gov (United States)

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

    2016-12-01

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

  17. 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

  18. 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

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

    Directory of Open Access Journals (Sweden)

    Elise Mok

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

  20. 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.

  1. Effect of xylitol on cariogenic and beneficial oral streptococci: a randomized, double-blind crossover trial.

    Science.gov (United States)

    Bahador, A; Lesan, S; Kashi, N

    2012-06-01

    Although habitual consumption of xylitol reduces cariogenic streptococci levels, its effect on beneficial oral streptococci is less clear. The main aim of the study is to investigate the effect of short-term xylitol consumption on the oral beneficial streptococci level of saliva, Streptococcus sanguinis and S. mitis. Twenty four volunteers with a median age of 23.7 years (range: 20-28) harboring Streptococcus mutans, S. sobrinus, S. sanguinis and S. mitis participated in the randomized, double-blind, cross-over study. The experimental chewing gum (1.5 g/pellet) contained 70% xylitol w/w while the control gum contained 63% sorbitol w/w. Saliva samples were collected before and after two three-week test periods with a four-week washout interval. Colony-forming units (CFU)/ml were enumerated for the estimation of S. mutans levels on Mitis Salivarius-Mutans valinomycin (MS-MUTV), S. sobrinus on Mitis Salivarius-Sobrinus (MS-SOB), S. sanguinis on Modified Medium 10-Sucrose (MM10-S) and S. mitis on Mitis Salivarius Agar with Tellurite (MSAT) media. The S. mutans and S. sobrinus counts of the saliva samples decreased significantly (p = 0.01 and p = 0.011, respectively) in the xylitol gum group but not in the sorbitol gum group. The salivary S. sanguinis and S. mitis counts did not decrease in both xylitol and sorbitol gum groups. Based on the findings of this study, xylitol consumption reduced S. mutans and S. sobrinus counts in saliva but appeared not to effect numbers of S. sanguinis and S. mitis in saliva. So, habitual consumption of xylitol reduces cariogenic streptococci levels without any effect on beneficial sterptococci for the oral cavity.

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

    Science.gov (United States)

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

    2016-07-01

    To evaluate two widely used control algorithms for an artificial pancreas (AP) under nonideal but comparable clinical conditions. After a pilot safety and feasibility study (n = 10), closed-loop control (CLC) was evaluated in a randomized, crossover trial of 20 additional adults with type 1 diabetes. Personalized model predictive control (MPC) and proportional integral derivative (PID) algorithms were compared in supervised 27.5-h CLC sessions. Challenges included overnight control after a 65-g dinner, response to a 50-g breakfast, and response to an unannounced 65-g lunch. Boluses of announced dinner and breakfast meals were given at mealtime. The primary outcome was time in glucose range 70-180 mg/dL. Mean time in range 70-180 mg/dL was greater for MPC than for PID (74.4 vs. 63.7%, P = 0.020). Mean glucose was also lower for MPC than PID during the entire trial duration (138 vs. 160 mg/dL, P = 0.012) and 5 h after the unannounced 65-g meal (181 vs. 220 mg/dL, P = 0.019). There was no significant difference in time with glucose PID control for the AP indicates that MPC performed particularly well, achieving nearly 75% time in the target range, including the unannounced meal. Although both forms of CLC provided safe and effective glucose management, MPC performed as well or better than PID in all metrics. © 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  3. Effects of antiseptic mouthwash on resting metabolic rate: A randomized, double-blind, crossover study.

    Science.gov (United States)

    Sundqvist, Michaela L; Lundberg, Jon O; Weitzberg, Eddie

    2016-12-30

    The nitrate-nitrite-nitric oxide pathway has emerged as a significant source of nitric oxide (NO) bioactivity. Dietary intake of inorganic nitrate has a number of cardiovascular effects as well as a decrease in oxygen cost during exercise and a reduction in resting metabolic rate (RMR). Oral bacteria have a key role in bioactivation of inorganic nitrate since they catalyse the conversion of salivary nitrate to the more reactive nitrite anion. Recent studies demonstrate that blood pressure increases with the use of an antiseptic mouthwash, indicating that endogenous, NO-synthase derived nitrate is recycled into nitrite and NO, sufficiently to modulate cardiovascular function. Here we tested if also RMR would be affected by an antiseptic mouthwash. Seventeen healthy normotensive female subjects (23 ± 4 y) participated in this randomized, double-blinded, crossover study. During two 3-day periods separated by 28 days the subjects consumed a diet low in nitrate combined with rinsing their mouth three times daily with a chlorhexidine-containing mouthwash (mouthwash) or placebo mouthwash (placebo) with similar taste but no antiseptic properties. Resting metabolic rate (RMR) was measured by indirect calorimetry and 24 h ambulatory blood pressure recordings were obtained after each intervention together with blood, saliva and urine samples. Treatment with chlorhexidine-containing mouthwash effectively reduced oral conversion of nitrate to nitrite but had no effect on plasma levels of these anions or plasma cGMP. RMR and 24 h ambulatory blood pressure were unaffected by the intervention. We conclude that in young healthy females an antiseptic mouthwash was effective in disrupting oral bacterial nitrate conversion to nitrite, but this was not associated with changes in plasma nitrite, RMR or blood pressure. Copyright © 2016 Elsevier Inc. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Xiaoliang Wang

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

  5. Efficacy of two mouthwashes on 3-day supragingival plaque regrowth: a randomized crossover clinical trial.

    Science.gov (United States)

    Marchetti, E; Casalena, F; Capestro, A; Tecco, S; Mattei, A; Marzo, G

    2017-02-01

    The aim of this study was to evaluate the antiplaque effects of an alcohol-free essential oil (alcohol-free EO) mouthwash and an amine fluoride/stannous fluoride with zinc lactate (SnFl-Zn) mouthwash compared to a positive control of chlorhexidine (CHX) mouthwash, using an in vivo plaque regrowth model of 3 days. The study was designed as a double-masked, randomized, crossover clinical trial, involving 20 volunteers to compare two different mouthwashes, using a 3-day plaque accumulation model. After receiving thorough professional prophylaxis at baseline, over the next 3 days, each volunteer refrained from all oral hygiene measures and performed two daily rinses with 20 ml of the test mouthwashes. A 0.20% CHX rinse served as a positive control. At the end of each experimental period, plaque was assessed, and the panellists completed a questionnaire. Each subject underwent a 14-day washout period, and then, there was another allocation. The SnFl-Zn mouthwash has shown a better inhibitory activity on plaque regrowth compared to the alcohol-free EO mouthwash in the whole mouth (plaque index = 1.93 against 2.45, respectively), but there was less of an effect compared to the CHX group, with an overall plaque index of 1.41. The differences of 0.52 between alcohol-free EO and SnFl-Zn and between SnFl-Zn and CHX and of 0.96 between alcohol-free EO and CHX were all statistically significant (P plaque regrowth than the amine fluoride/SnFl-Zn mouthwash and the CHX control. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  6. A randomized crossover trial of the impact of additional spermicide on condom failure rates.

    Science.gov (United States)

    Gabbay, Mark B; Thomas, Joanna; Gibbs, Alan; Hold, Phoebe

    2008-10-01

    Opinions remain divided concerning the potential for additional water-based lubricant to reduce condom breaks and slips. We sought to explore impact of externally applied additional lubrication on condom failure rates among regular users in stable heterosexual relationships. To compare condom failure rates with and without additional spermicide. Couples randomized to use up to 70 condoms alone (control) or with additional spermicide (intervention), with midpoint crossover. Couple demographic and failure risk data collected at baseline. Follow ups at three and six months recorded condom failure events, spermicide acceptability, side-effects and adverse events. Condom failure rates were compared using an intention to treat analysis. Altogether 12,530 condoms were used by 145 couples completing the trial, There were 45/6,463:0.70% (95% CI 0.51%-0.93%) clinical and nonclinical failures in the additional spermicide arm, compared to 111/6,067:1.83% (95% CI 1.51%-2.20%) during the control arm. The clinical condom failure rate was 0.53% (95% CI 0.41%-0.66%), with 19 (0.31%: 95% CI 0.18%-0.43%) during the additional spermicide arm, compared to 46 (0.77%: 95% CI 0.56%-0.99%) during the control arm. Couples experienced significantly lower total (P = 0.017) and clinical (P = 0.042) condom failure rates during the additional spermicide arm. Furthermore additional spermicide significantly reduced clinical failures among the 101 couples who'd experienced a previous condom failure (P = 0.002). There were 22 urinary tract infections, equally divided between the control and additional spermicide arms, however 10 of the 12 genital irritation episodes occurred with additional spermicide (P = 0.021). Additional water-based external lubricant significantly reduced condom failures despite low failure rates among this stable, experienced group of condom users. Our results suggest that this may be a useful supplement to condom use, particularly among couples who experienced condom failures

  7. Meal timing affects glucose tolerance, substrate oxidation and circadian-related variables: A randomized, crossover trial.

    Science.gov (United States)

    Bandín, C; Scheer, F A J L; Luque, A J; Ávila-Gandía, V; Zamora, S; Madrid, J A; Gómez-Abellán, P; Garaulet, M

    2015-05-01

    Timing of food intake associates with body weight regulation, insulin sensitivity and glucose tolerance. However, the mechanism is unknown. The aim of this study was to investigate the effects of changes in meal timing on energy-expenditure, glucose-tolerance and circadian-related variables. Thirty-two women (aged 24±4 years and body mass index 22.9±2.6 kg m(-2)) completed two randomized, crossover protocols: one protocol (P1) including assessment of resting-energy expenditure (indirect-calorimetry) and glucose tolerance (mixed-meal test) (n=10), the other (P2) including circadian-related measurements based on profiles in salivary cortisol and wrist temperature (Twrist) (n=22). In each protocol, participants were provided with standardized meals (breakfast, lunch and dinner) during the two meal intervention weeks and were studied under two lunch-eating conditions: Early Eating (EE; lunch at 13:00) and Late Eating (LE; lunch 16:30). LE, as compared with EE, resulted in decreased pre-meal resting-energy expenditure (P=0.048), a lower pre-meal protein-corrected respiratory quotient (CRQ) and a changed post-meal profile of CRQ (P=0.019). These changes reflected a significantly lower pre-meal utilization of carbohydrates in LE versus EE (P=0.006). LE also increased glucose area under curve above baseline by 46%, demonstrating decreased glucose tolerance (P=0.002). Changes in the daily profile of cortisol and Twrist were also found with LE blunting the cortisol profile, with lower morning and afternoon values, and suppressing the postprandial Twrist peak (Pfood on Twrist. These results may be implicated in the differential effects of meal timing on metabolic health.

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

    Science.gov (United States)

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

    2018-02-01

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

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

    Science.gov (United States)

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

    2018-02-01

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

  10. 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.

  11. 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

  12. 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.

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Science.gov (United States)

    2012-01-01

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

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

    Science.gov (United States)

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

    2017-06-22

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

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

    Science.gov (United States)

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

    2017-08-15

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

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

    Directory of Open Access Journals (Sweden)

    Dixon H

    2017-04-01

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

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

    Science.gov (United States)

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

    2016-01-08

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

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

    Science.gov (United States)

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

    2015-06-01

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

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

    DEFF Research Database (Denmark)

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

    2009-01-01

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

  1. A Randomized Crossover Comparison of Team-based Learning and Lecture Format on Learning Outcomes.

    Science.gov (United States)

    Bleske, Barry E; Remington, Tami L; Wells, Trisha D; Klein, Kristin C; Guthrie, Sally K; Tingen, Jeffrey M; Marshall, Vincent D; Dorsch, Michael P

    2016-09-25

    Objective. To compare learning outcomes and student confidence between team-based learning (TBL) and lecture. Methods. A crossover study was conducted with 30 students divided into two sections. Each section was taught six therapeutic topics (three TBL and three lecture). There were two assessments of 24 questions each. A survey (Likert scale) assessing student confidence and attitudes was administered at the end. Results. A significantly higher overall examination score was observed for TBL as compared to lecture. Students were more confident in providing therapeutic recommendations following TBL. Higher survey scores favoring TBL were also seen related to critical-thinking skills and therapeutic knowledge. Conclusion. Learning outcomes and student confidence in performing higher-order tasks were significantly higher with TBL. The findings of this novel crossover type design showed that TBL is an effective pedagogy.

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

    Science.gov (United States)

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

    2017-05-01

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

  3. A preliminary investigation into the effects of active interferential current therapy and placebo on pressure pain sensitivity: a random crossover placebo controlled study.

    Science.gov (United States)

    Fuentes C, Jorge; Armijo-Olivo, Susan; Magee, David J; Gross, Douglas P

    2011-12-01

    (1) To determine the effect of active and placebo interferential current on muscle pain sensitivity using an experimental mechanically induced pain model. (2) To evaluate the predictive role of expectations, gender, baseline muscle pain sensitivity, and intervention order on placebo response. Randomized placebo controlled cross-over trial. University research laboratory. Forty healthy volunteers (20 females, 20 males). Active interferential current, placebo (sham) interferential current, and no treatment/control were applied to the lumbar area on different days. Pressure pain thresholds and placebo response. The two-way ANOVA with repeated measures analysis determined a significant interaction between condition and time (P=0.002). Pairwise comparisons found differences between active interferential and the control condition at 15 minutes into treatment (mean difference=0.890 kg/cm(2), 95% CI 0.023 to 1.757, P=0.043) and at 30 minutes into treatment (mean difference=0.910 kg/cm(2), 95% CI 0.078 to 1.742, P=0.028). The increase in pressure pain thresholds between the active interferential and the control condition (1.12 kg/cm(2)) was clinically meaningful. Logistic regression analysis showed that the condition sequence order was the only variable that predicted placebo response (odds ratio 9.7; P=0.028). If a subject started the sequence receiving placebo treatment first, the odds of responding to placebo would be approximately 10 times higher (i.e. 90% probability of being a placebo responder) than that of starting with an active treatment. Active interferential was more efficient than control condition in decreasing muscle pain sensitivity. Placebo interferential was not significantly different from control. Treatment sequence demonstrated a strong association with placebo response. These findings have implications for future research characterizing and identifying placebo responders in physiotherapy. Copyright © 2011 Chartered Society of Physiotherapy

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

    DEFF Research Database (Denmark)

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

    2006-01-01

    to yield the corresponding flavonoid glucoside (i.e., hesperetin-7-glucoside) will improve the bioavailability of the aglycone hesperetin. Healthy volunteers (n = 16) completed the double-blind, randomized, crossover study. Subjects randomly consumed hesperetin equivalents supplied as orange juice...... with natural hesperidin ("low dose"), orange juice treated with hesperidinase enzyme to yield hesperetin-7-glucoside, and orange juice fortified to obtain 3 times more hesperidin than naturally present ("high dose"). The area under the curve (AUC) for total plasma hesperetin of subjects consuming hesperetin-7......Hesperidin is the predominant polyphenol consumed from citrus fruits and juices. However, hesperidin is proposed to have limited bioavailability due to the rutinoside moiety attached to the flavonoid. The aim of this study was to demonstrate in human subjects that the removal of the rhamnose group...

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

    Science.gov (United States)

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

    2016-01-25

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

  6. 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.

  7. Two-Way Bilingual Education and Latino Students

    Science.gov (United States)

    Brooke-Garza, Elizabeth

    2015-01-01

    Two-way bilingual immersion (TWBI) programs have demonstrated great success in improving Latino English learners' educational outcomes. Nevertheless, TWBI classrooms are not immune to the greater power dynamics and influences of United States society. This Participatory Action Research study brought together eight two-way bilingual immersion…

  8. 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.

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

    Science.gov (United States)

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

    2002-10-01

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

  10. Can Two-Way Direct Communication Protocols Be Considered Secure?

    Science.gov (United States)

    Pavičić, Mladen

    2017-09-01

    We consider attacks on two-way quantum key distribution protocols in which an undetectable eavesdropper copies all messages in the message mode. We show that under the attacks, there is no disturbance in the message mode and that the mutual information between the sender and the receiver is always constant and equal to one. It follows that recent proofs of security for two-way protocols cannot be considered complete since they do not cover the considered attacks.

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

    Science.gov (United States)

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

    2017-02-01

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

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

    DEFF Research Database (Denmark)

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

    2005-01-01

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

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

    Science.gov (United States)

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

    2016-03-01

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

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

    Science.gov (United States)

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

    2004-04-01

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

  16. Mexiletine for Muscle Cramps in ALS: A Randomized Double-Blind Crossover Trial.

    Science.gov (United States)

    Oskarsson, Björn; Moore, Dan; Mozaffar, Tahseen; Ravits, John; Wiedau-Pazos, Martina; Parziale, Nicholas; Joyce, Nanette C; Mandeville, Ross; Goyal, Namita; Cudkowicz, Merit E; Weiss, Michael; Miller, Robert G; McDonald, Craig M

    2018-03-06

    More than 90% of amyotrophic lateral sclerosis (ALS) patients have muscle cramps, and evidence-based treatments have not been available. A multicenter double-blind placebo-controlled crossover trial of mexiletine 150 mg twice daily was conducted of ALS patients requesting treatment of symptomatic muscle cramps. Muscle cramp frequency was reduced in 18 of 20 patients; 13 reductions were attributed to treatment (Pcramps per day (a reduction from 5.3 with placebo to 3.5 with mexiletine) based on t tests. The estimated reduction of cramp severity was 15 units on a 100-unit scale (P=.01), from a baseline average of 46. No effect on fasciculations was noted. One patient discontinued the study because of dizziness, and another patient discontinued the study to start open-label mexiletine therapy. No serious adverse event occurred. Mexiletine is well-tolerated and effective medication for controlling the symptom of muscle cramps in ALS. This article is protected by copyright. All rights reserved. © 2018 Wiley Periodicals, Inc.

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

    DEFF Research Database (Denmark)

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

    1996-01-01

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

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

    DEFF Research Database (Denmark)

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

    2008-01-01

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

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

    NARCIS (Netherlands)

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

    2009-01-01

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

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

    NARCIS (Netherlands)

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

    2017-01-01

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

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

    DEFF Research Database (Denmark)

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

    2008-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Matthias Huber

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

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

    Science.gov (United States)

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

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

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

    Science.gov (United States)

    Chinwong, Surarong; Chinwong, Dujrudee; Mangklabruks, Ampica

    2017-01-01

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

  5. Evaluation of a new PVC-free catheter material for intermittent catheterization: a prospective, randomized, crossover study.

    Science.gov (United States)

    Johansson, Kerstin; Greis, Gunvor; Johansson, Birgit; Grundtmann, Agneta; Pahlby, Yvonne; Törn, Solveig; Axelberg, Hanna; Carlsson, Petrea

    2013-02-01

    Polyvinyl chloride (PVC) is commonly used as a catheter material in catheters for clean intermittent catheterization (CIC) but, owing mainly to environmental concerns, a PVC-free material has been proposed. The objective of this study was to compare patients' tolerability for catheters made of PVC and a newly developed PVC-free material. This was a prospective, randomized, crossover study in 104 male patients with maintained urethra sensibility who practised CIC. The patients evaluated in a randomized order a PVC and a PVC-free LoFric® catheter after 1 week's use of each. The material properties and tolerability, i.e. reported perceived discomfort, of each catheter were compared and adverse events documented. Twenty-nine (28%) and 15 (14%) patients reported discomfort when using the PVC catheter and the PVC-free LoFric catheter, respectively. A comparison showed that five patients (5%) reported discomfort with the PVC-free and not with the PVC catheter, and 19 patients (18%) reported discomfort with the PVC and not with the PVC-free catheter (p = 0.0066). Forty patients reported a total of 91 adverse events, of which the most common were discomfort in terms of pain, a burning sensation and bleeding. Generally low discomfort rates were reported in the study population, suggesting a high tolerance for CIC with catheters of both the PVC and the PVC-free materials. The lowest discomfort was, however, found when CIC was performed using the PVC-free LoFric catheter.

  6. Modafinil improves real driving performance in patients with hypersomnia: a randomized double-blind placebo-controlled crossover clinical trial.

    Science.gov (United States)

    Philip, Pierre; Chaufton, Cyril; Taillard, Jacques; Capelli, Aurore; Coste, Olivier; Léger, Damien; Moore, Nicholas; Sagaspe, Patricia

    2014-03-01

    Patients with excessive daytime sleepiness (EDS) are at high risk for driving accidents, and physicians are concerned by the effect of alerting drugs on driving skills of sleepy patients. No study has up to now investigated the effect of modafinil (a reference drug to treat EDS in patients with hypersomnia) on on-road driving performance of patients suffering from central hypersomnia. The objective is to evaluate in patients with central hypersomnia the effect of a wake-promoting drug on real driving performance and to assess the relationship between objective sleepiness and driving performance. Randomized, crossover, double-blind placebo-controlled trial conducted among 13 patients with narcolepsy and 14 patients with idiopathic hypersomnia. Patients were randomly assigned to receive modafinil (400 mg) or placebo for 5 days prior to the driving test. Each condition was separated by at least 3 weeks of washout. Mean number of Inappropriate Line Crossings, Standard Deviation of Lateral Position of the vehicle and mean sleep latency in the Maintenance of Wakefulness Test were assessed. Modafinil reduced the mean number of Inappropriate Line Crossings and Standard Deviation of Lateral Position of the vehicle compared to placebo (F(1,25) = 4.88, P Modafinil improves driving performance in patients with narcolepsy and idiopathic hypersomnia. The Maintenance of Wakefulness Test is a suitable clinical tool to assess fitness to drive in this population.

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

    Science.gov (United States)

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

    2015-07-01

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

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

    Directory of Open Access Journals (Sweden)

    Surarong Chinwong

    2017-01-01

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

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

    African Journals Online (AJOL)

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

  10. Two-Way Regularized Fuzzy Clustering of Multiple Correspondence Analysis.

    Science.gov (United States)

    Kim, Sunmee; Choi, Ji Yeh; Hwang, Heungsun

    2017-01-01

    Multiple correspondence analysis (MCA) is a useful tool for investigating the interrelationships among dummy-coded categorical variables. MCA has been combined with clustering methods to examine whether there exist heterogeneous subclusters of a population, which exhibit cluster-level heterogeneity. These combined approaches aim to classify either observations only (one-way clustering of MCA) or both observations and variable categories (two-way clustering of MCA). The latter approach is favored because its solutions are easier to interpret by providing explicitly which subgroup of observations is associated with which subset of variable categories. Nonetheless, the two-way approach has been built on hard classification that assumes observations and/or variable categories to belong to only one cluster. To relax this assumption, we propose two-way fuzzy clustering of MCA. Specifically, we combine MCA with fuzzy k-means simultaneously to classify a subgroup of observations and a subset of variable categories into a common cluster, while allowing both observations and variable categories to belong partially to multiple clusters. Importantly, we adopt regularized fuzzy k-means, thereby enabling us to decide the degree of fuzziness in cluster memberships automatically. We evaluate the performance of the proposed approach through the analysis of simulated and real data, in comparison with existing two-way clustering approaches.

  11. Transfer as a two-way process: testing a model

    NARCIS (Netherlands)

    Vermeulen, R.; Admiraal, W.

    2009-01-01

    Purpose - The purpose of this exploratory research is to test the model of training transfer as a two-way process. Design/methodology/approach - Based on self-report data gathered from 58 to 44 respondents in a field experiment, it is argued that there is not just learning in the context of training

  12. Uniform load coefficients for beams in reinforced concrete two - way ...

    African Journals Online (AJOL)

    While designing reinforced concrete two - way slab systems, triangular or trapezoidal loadings are encountered during transferring the slab loading to the supporting beams. When analysing continuous beams, uniform loading conditions are, as much as possible, preferred because of their simplicity. In this paper, respective ...

  13. Bilingual Two-Way Immersion Programs Benefit Academic Achievement

    Science.gov (United States)

    Marian, Viorica; Shook, Anthony; Schroeder, Scott R.

    2013-01-01

    The effects of bilingual education on reading and math achievement were examined by comparing test scores across different elementary school programs. Results revealed that bilingual Two-Way Immersion (TWI) programs benefited both minority-language and majority-language students. Minority-language students in TWI programs outperformed their peers…

  14. Two-way quantum key distribution at telecommunication wavelength

    International Nuclear Information System (INIS)

    Kumar, Rupesh; Lucamarini, Marco; Di Giuseppe, Giovanni; Natali, Riccardo; Mancini, Giorgio; Tombesi, Paolo

    2008-01-01

    We report on a quantum key distribution effected with a two-way deterministic protocol over a standard telecommunication fiber. Despite the common belief of a prohibitive loss rate for such a scheme, our results show its feasibility on distances of few tenths of kilometers

  15. 33 CFR 157.136 - Two-way voice communications.

    Science.gov (United States)

    2010-07-01

    ... (CONTINUED) POLLUTION RULES FOR THE PROTECTION OF THE MARINE ENVIRONMENT RELATING TO TANK VESSELS CARRYING OIL IN BULK Crude Oil Washing (COW) System on Tank Vessels Design, Equipment, and Installation § 157.136 Two-way voice communications. Each tank vessel having a COW system under § 157.10(e), § 157.10a(a...

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

    Science.gov (United States)

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

    2015-06-17

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

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

    Science.gov (United States)

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

    2017-05-01

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

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

    Science.gov (United States)

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

    2016-01-01

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

  19. Evaluation of Salvadora persica L. and green tea anti-plaque effect: a randomized controlled crossover clinical trial.

    Science.gov (United States)

    Abdulbaqi, Hayder Raad; Himratul-Aznita, Wan Harun; Baharuddin, Nor Adinar

    2016-12-01

    In the author's earlier in vitro investigation, a combination of 0.25 mg/ml green tea and 7.82 mg/ml Salvadora persica L. aqueous extracts was found to exhibit significant synergistic anti-bacterial and anti-adherence effects against primary plaque colonizers biofilm. A clinical trial was needed to support these preliminary in vitro results and to investigate its efficacy as a mouthwash in the control of dental plaque. A 24 h plaque re-growth, double-blinded, randomized crossover trial was carried out. Participants (n = 14) randomly rinsed with test formulation, 0.12% chlorhexidine (control) and placebo mouthwashes for 24 h. A week before the trial, all participants received scaling, polishing and oral hygiene education. On the trial day, the participants received polishing at baseline and rinsed with 15 ml of randomly allocated mouthwash twice daily without oral hygiene measures. After 24 h, plaque index was scored and then the participants entered a 6-days washout period with regular oral hygiene measures. The same protocol was repeated for the next 2 mouthwashes. The results were expressed as mean (±SD) plaque index. The test mouthwash (0.931 ± 0.372) significantly reduced plaque accumulation when compared with placebo (1.440 ± 0.498, p chlorhexidine (1.317 ± 0.344, p chlorhexidine and placebo (p > 0.0167). The test mouthwash has an anti-plaque effect for a 24 h period. Longer-term clinical studies are highly encouraged to investigate its anti-plaque effect for longer periods. This study was registered in ClinicalTrials.gov as NCT02624336 in December 3, 2015.

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

    Science.gov (United States)

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

    2017-05-23

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

  1. A two-way regularization method for MEG source reconstruction

    KAUST Repository

    Tian, Tian Siva

    2012-09-01

    The MEG inverse problem refers to the reconstruction of the neural activity of the brain from magnetoencephalography (MEG) measurements. We propose a two-way regularization (TWR) method to solve the MEG inverse problem under the assumptions that only a small number of locations in space are responsible for the measured signals (focality), and each source time course is smooth in time (smoothness). The focality and smoothness of the reconstructed signals are ensured respectively by imposing a sparsity-inducing penalty and a roughness penalty in the data fitting criterion. A two-stage algorithm is developed for fast computation, where a raw estimate of the source time course is obtained in the first stage and then refined in the second stage by the two-way regularization. The proposed method is shown to be effective on both synthetic and real-world examples. © Institute of Mathematical Statistics, 2012.

  2. Teaching nursing research using two-way video technology.

    Science.gov (United States)

    Parks, P L; O'Shea, K

    1995-06-01

    Schools of nursing are meeting the needs of students by instituting distance education courses that use two-way video technology. This article describes the structural features of the classroom that are changed and provides strategies that can be effective for teaching nursing research. These strategies are related to: teaching and demonstrating use of statistical formulas; selecting and teaching use of software for data analysis; teaching about research design, sampling, and data collection procedures; and critiquing empirical articles.

  3. Lexical need as a two-way reality cognition tool

    OpenAIRE

    Mark Kit; Elena Berg

    2014-01-01

    Lexical need as a two-way reality cognition tool In this paper a concept of lexical need is introduced and its application in research of cognitive aspects of translation is discussed. Further discussion elaborates mechanisms of development of translator’s lexical space in the course of translation. Authors discuss the importance and special nature of low-frequency lexical units and difficulties encountered when studying their usage and suggest that the lexical need concept help these stu...

  4. Emulsifying dietary fat modulates postprandial endotoxemia associated with chylomicronemia in obese men: a pilot randomized crossover study.

    Science.gov (United States)

    Vors, Cécile; Drai, Jocelyne; Pineau, Gaëlle; Laville, Martine; Vidal, Hubert; Laugerette, Fabienne; Michalski, Marie-Caroline

    2017-05-25

    Postprandial hyperlipemia is recognized as a major cardio-metabolic risk factor, recently linked to the co-absorption of pro-inflammatory lipopolysaccharides with dietary lipids. This causes endotoxemia that is involved in the pathophysiology of obesity and insulin resistance, but to date the impact of food formulation is unknown. We tested a novel concept that endotoxin absorption can be modulated by fat emulsified structure in the meal, and potentially differently in obese vs. lean men. In a randomized controlled crossover study, eight normal-weight and eight obese age-matched healthy men ingested two isocaloric, isolipidic breakfasts of identical composition including 40 g of milk fat that was emulsified or unemulsified. Plasma- and chylomicron-endotoxemia and chylomicron-triglycerides were measured during 8 h after breakfast ingestion. After emulsion consumption, parallel to an enhanced chylomicronemia, obese subjects presented an early and sharp increase in chylomicron-endotoxemia at 60 min (P time  = 0.02), which was higher than (i) after spread fat in obese subjects (P endotoxemia over 8 h was lower after emulsion than after spread fat (P metabolic impact of postprandial endotoxemia in obese men. Registered at ClinicalTrials.gov # NCT01249378 on July 13, 2010.

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

    Science.gov (United States)

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

    2016-05-01

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

  6. The effect of modafinil on cortical excitability in patients with narcolepsy: a randomized, placebo-controlled, crossover study.

    Science.gov (United States)

    Joo, Eun Yeon; Hong, Seung Bong; Kim, He-Jung; Lim, Yang-Hee; Koo, Dae-Lim; Ji, Ki-Hwan; Tae, Woo Suk

    2010-10-01

    To investigate the effect of modafinil on cortical excitability in patients with narcolepsy using transcranial magnetic stimulation (TMS). Nineteen drug-naïve narcolepsy patients with cataplexy (10 males, 9 females, and mean age 28.5 years) and 25 age- and sex-matched healthy controls were recruited. In this double-blind, randomized, crossover study, patients and controls received a single dose of 400mg modafinil or placebo. Modafinil and placebo administrations were separated by a 2-week washout period. TMS parameters, such as resting motor thresholds (RMT), motor-evoked potential (MEP) amplitudes, cortical silent periods (CSP), short-interval intracortical inhibition (SICI), and intracortical facilitation (ICF), were measured before and 3h after administering modafinil or placebo. The differences of TMS parameters were statistically tested between patients and controls and between before and after modafinil or placebo administration. Narcolepsy patients had significantly increased CSP durations compared to controls (independent t-test, Pmodafinil administration, MEP amplitudes, SICI, and ICF increased, and CSP duration shortened significantly, meaning enhanced motor excitability, whereas in controls modafinil did not change TMS parameters significantly. Placebo administration did not affect TMS parameters both in patients or controls. Narcolepsy patients with cataplexy showed decreased cortical excitability than normal healthy controls. Single dose modafinil significantly increased motor excitability in narcolepsy patients but had no effect in healthy controls.

  7. 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.

  8. MRI-related static magnetic stray fields and postural body sway: a double-blind randomized crossover study.

    Science.gov (United States)

    van Nierop, Lotte E; Slottje, Pauline; Kingma, Herman; Kromhout, Hans

    2013-07-01

    We assessed postural body sway performance after exposure to movement induced time-varying magnetic fields in the static magnetic stray field in front of a 7 Tesla (T) magnetic resonance imaging scanner. Using a double blind randomized crossover design, 30 healthy volunteers performed two balance tasks (i.e., standing with eyes closed and feet in parallel and then in tandem position) after standardized head movements in a sham, low exposure (on average 0.24 T static magnetic stray field and 0.49 T·s(-1) time-varying magnetic field) and high exposure condition (0.37 T and 0.70 T·s(-1)). Personal exposure to static magnetic stray fields and time-varying magnetic fields was measured with a personal dosimeter. Postural body sway was expressed in sway path, area, and velocity. Mixed-effects model regression analysis showed that postural body sway in the parallel task was negatively affected (P < 0.05) by exposure on all three measures. The tandem task revealed the same trend, but did not reach statistical significance. Further studies are needed to investigate the possibility of independent or synergetic effects of static magnetic stray field and time-varying magnetic field exposure. In addition, practical safety implications of these findings, e.g., for surgeons and others working near magnetic resonance imaging scanners need to be investigated. Copyright © 2012 Wiley Periodicals, Inc.

  9. 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

  10. Nonequilibrium dynamical renormalization group: Dynamical crossover from weak to infinite randomness in the transverse-field Ising chain

    Science.gov (United States)

    Heyl, Markus; Vojta, Matthias

    2015-09-01

    In this work we formulate the nonequilibrium dynamical renormalization group (ndRG). The ndRG represents a general renormalization-group scheme for the analytical description of the real-time dynamics of complex quantum many-body systems. In particular, the ndRG incorporates time as an additional scale which turns out to be important for the description of the long-time dynamics. It can be applied to both translational-invariant and disordered systems. As a concrete application, we study the real-time dynamics after a quench between two quantum critical points of different universality classes. We achieve this by switching on weak disorder in a one-dimensional transverse-field Ising model initially prepared at its clean quantum critical point. By comparing to numerically exact simulations for large systems, we show that the ndRG is capable of analytically capturing the full crossover from weak to infinite randomness. We analytically study signatures of localization in both real space and Fock space.

  11. 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...... calcium concentration of 1.25 mmol/L and a fixed alfacalcidol dose for at least 2 months. All had previously tolerated therapy with calcium carbonate. Of the 19 patients included, 10 completed both treatment arms. After 12 weeks of therapy, the mean (+/-SEM) plasma ionized calcium level was significantly...... 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...

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

    Directory of Open Access Journals (Sweden)

    C.-Y. Oliver Chen

    2017-02-01

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

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

    Directory of Open Access Journals (Sweden)

    Bergur V. Stefánsson

    2012-03-01

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

  15. A Randomized, Double-Blind, Crossover Pilot Trial of Rice Endosperm Protein Supplementation in Maintenance Hemodialysis Patients.

    Science.gov (United States)

    Hosojima, Michihiro; Shimada, Hisaki; Obi, Yoshitsugu; Kuwahara, Shoji; Kaseda, Ryohei; Kabasawa, Hideyuki; Kondo, Hazuki; Fujii, Mikio; Watanabe, Reiko; Suzuki, Yoshiki; Kadowaki, Motoni; Miyazaki, Shigeru; Saito, Akihiko

    2017-12-21

    In maintenance hemodialysis (MHD) patients, low protein intake is associated with protein-energy wasting, a risk factor that affects outcome. However, increased protein intake may lead to hyperphosphatemia and hyperkalemia, which are also mortality risk factors. Here, we evaluated the safety and effects of purified rice endosperm protein (REP), which contains less phosphorus and potassium than soy and casein proteins, as a supplemental protein source for MHD patients. This randomized, double-blind, placebo-controlled, crossover pilot study of REP supplementation (5 g/day × 4 weeks) was carried out in 50 Japanese adult MHD patients (1 dropped out); the primary outcome was the change in the urea kinetic-based normalized protein catabolic rate (nPCR), an indicator of protein intake in MHD patients. Intention-to-treat analyses of 24 patients in the REP-first group and 25 in the placebo-first group showed that REP supplementation increased nPCR significantly by 0.07 g/kg/day (95% confidence interval, 0.03-0.11), whereas changes in serum phosphorus and potassium concentrations were not different from the placebo. REP supplementation did not show a significant effect on other nutritional or metabolic parameters and no specific complications. In conclusion, purified REP with efficient bioavailability may be safe and useful for dietary supplementation in MHD patients.

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

    Science.gov (United States)

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

    2014-04-01

    Epidemiological research links aggression to low serum concentrations of omega-3 fatty acids, such as those found in fish oil. However, no studies have specifically examined whether fish oil supplementation can reduce the frequency and severity of impulsive aggression in children with disruptive behavior disorders. Children presenting with impulsive aggression and meeting research criteria for diagnosis of disruptive behavior disorders were randomized to receive either: 1) Fish oil capsules (4 g daily) for 6 weeks followed by placebo (identical-looking capsules) for 6 weeks; or 2) placebo for 6 weeks, followed by fish oil for 6 weeks, in a double-blind, crossover design. Primary outcomes were the Children's Aggression Scale and the Modified Overt Aggression Scale. Secondary outcomes included emotional and behavioral functioning (Strengths and Difficulties Questionnaire [SDQ]), hyperactivity symptoms (Attention-Deficit/Hyperactivity Disorder [ADHD] Rating Scale), family functioning (Family Assessment Device), and cognitive functioning (Stop Signal Task, Trail-Making Task, and Eriksen Flanker Task). Serum concentrations of omega-3 and omega-6 fatty acids were measured at baseline, and at 6 and 12 weeks. Twenty-one children participated (81% male; mean age 10.3±2.2 years; range 7-14). Fish oil treatment increased serum concentrations of eicosapentanoic acid (F=14.76, pConduct Subscale, F=4.34, p=0.06). Fish oil treatment was associated with an improvement in one rating of hyperactivity (SDQ Hyperactivity Subscale, F=2.22, pchildren with disruptive behavior disorders.

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

    Science.gov (United States)

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

    2014-09-01

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

  18. Soluble corn fiber increases bone calcium retention in postmenopausal women in a dose-dependent manner: a randomized crossover trial.

    Science.gov (United States)

    Jakeman, Steven A; Henry, Courtney N; Martin, Berdine R; McCabe, George P; McCabe, Linda D; Jackson, George S; Peacock, Munro; Weaver, Connie M

    2016-09-01

    Dietary soluble corn fiber (SCF) significantly improves calcium absorption in adolescents and the bone strength and architecture in rodent models. In this study, we aimed to determine the skeletal benefits of SCF in postmenopausal women. We used our novel technology of determining bone calcium retention by following the urinary appearance of (41)Ca, a rare long-lived radioisotope, from prelabeled bone to rapidly and sensitively evaluate the effectiveness of SCF in reducing bone loss. A randomized-order, crossover, double-blinded trial was performed in 14 healthy postmenopausal women to compare doses of 0, 10, and 20 g fiber from SCF/d for 50 d. A dose-response effect was shown with 10 and 20 g fiber from SCF/d, whereby bone calcium retention was improved by 4.8% (P fiber from SCF/d (8%; P = 0.035). Daily SCF consumption significantly increased bone calcium retention in postmenopausal women, which improved the bone calcium balance by an estimated 50 mg/d. This study was registered at clinicaltrials.gov as NCT02416947. © 2016 American Society for Nutrition.

  19. The pharmacokinetic and pharmacodynamic properties of different formulations of biphasic insulin aspart: a randomized, glucose clamp, crossover study.

    Science.gov (United States)

    Heise, T; Eckers, U; Kanc, K; Nielsen, J N; Nosek, L

    2008-12-01

    Type 2 diabetes patients on premixed insulin are commonly prescribed biphasic insulin with low prandial insulin content, such as biphasic insulin aspart (BIAsp) 30, comprising 30% insulin aspart (IAsp). The new formulations BIAsp 50 and BIAsp 70 contain 50% and 70% soluble IAsp, respectively. We compared the pharmacodynamics (PD) and pharmacokinetics (PK) of BIAsp 30, 50, and 70 and IAsp in a glucose clamp trial. In this randomized, double-blind, crossover study at a clinical research institute, 32 type 1 diabetes patients on basal-bolus therapy each underwent four glucose clamps (clamp level 5 mmol/L, duration 28 h post-dosing [12 h for IAsp]) and received a single dose of 0.4 U/kg BIAsp 30, 50, or 70 and IAsp. Main PD/PK outcome parameters measured were early- and late-phase glucose disposal (area under the curve of glucose infusion rate [AUC(GIR)]), nonesterified fatty acid concentrations, and IAsp concentrations. With increasing proportions of soluble IAsp, the insulin formulations showed significantly higher early metabolic activity (ratio of AUC(GIR) 0-6 h: BIAsp 50/BIAsp 30 = 1.28 [P IAsp/BIAsp 70 = 1.15 [P IAsp levels were significantly greater and late PK concentrations were significantly lower with increasing proportion of soluble IAsp. There are significant differences between the early and late PD and PK effects among BIAsp 30, 50, and 70 and IAsp that should allow tailored treatment with the convenience of prandial and basal insulin in each injection.

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Science.gov (United States)

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

    2017-06-28

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

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

    Science.gov (United States)

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

    2017-08-25

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

  3. Polyphenol rich olive oils improve lipoprotein particle atherogenic ratios and subclasses profile: A randomized, crossover, controlled trial.

    Science.gov (United States)

    Fernández-Castillejo, Sara; Valls, Rosa-Maria; Castañer, Olga; Rubió, Laura; Catalán, Úrsula; Pedret, Anna; Macià, Alba; Sampson, Maureen L; Covas, María-Isabel; Fitó, Montserrat; Motilva, Maria-José; Remaley, Alan T; Solà, Rosa

    2016-07-01

    Lipoprotein particle measures performed by nuclear magnetic resonance (NMR), and associated ratios, may be better markers for atherosclerosis risk than conventional lipid measures. The effect of two functional olive oils, one enriched with its polyphenols (FVOO, 500 ppm), and the other (FVOOT) with them (250 ppm) and those of thyme (250 ppm), versus a standard virgin olive oil (VOO), on lipoprotein particle atherogenic ratios and subclasses profiles was assessed. In a randomized, double-blind, crossover, controlled trial, 33 hypercholesterolemic individuals received 25 mL/day of VOO, FVOO, and FVOOT. Intervention periods were of 3 weeks separated by 2-week washout periods. Lipoprotein particle counts and subclasses were measured by NMR. Polyphenols from olive oil and thyme modified the lipoprotein subclasses profile and decreased the total LDL particle/total HDL particle (HDL-P), small HDL/large HDL, and HDL-cholesterol/HDL-P ratios, and decreased the lipoprotein insulin resistance index (LP-IR) (p Olive oil polyphenols, and those from thyme provided benefits on lipoprotein particle atherogenic ratios and subclasses profile distribution. Polyphenol-enriched olive oil is a way of increasing the olive oil healthy properties while consuming the same amount of fat, as well as a useful and complementary tool for the management of cardiovascular risk individuals. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  4. 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.

  5. 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.

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

    Science.gov (United States)

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

    2015-08-01

    It is unknown if tenofovir disoproxil fumarate (TDF), which is often coformulated with the lipid-neutral emtricitabine (FTC), has a lipid-lowering effect. We performed a randomized, crossover, double-blind, placebo-controlled clinical trial on human immunodeficiency virus type 1 (HIV-1)-infected subjects with HIV-1 RNA placebo (washout) and 12 additional weeks of placebo (placebo period). Subjects in arm 2 added placebo for 12 weeks (placebo period) followed by TDF/FTC for 12 weeks and placebo for 12 additional weeks (washout). The primary endpoint was change in median fasting TC levels. Of 46 subjects enrolled, 56% received darunavir/ritonavir and 44% lopinavir/ritonavir. Exposure to TDF/FTC reduced TC from 234 to 205 mg/dL (P placebo (P = .001 and P = .002, respectively). The TC/HDL-c ratio and triglyceride levels did not change with TDF/FTC exposure. Coformulated TDF/FTC has an intrinsic lipid-lowering effect, likely attributable to TDF. NCT01458977. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

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

    Science.gov (United States)

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

    2017-10-01

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

  8. 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.
.

  9. 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.

  10. Time-dependent effects of aspirin on blood pressure and morning platelet reactivity: a randomized cross-over trial.

    Science.gov (United States)

    Bonten, Tobias N; Snoep, Jaapjan D; Assendelft, Willem J J; Zwaginga, Jaap Jan; Eikenboom, Jeroen; Huisman, Menno V; Rosendaal, Frits R; van der Bom, Johanna G

    2015-04-01

    Aspirin is used for cardiovascular disease (CVD) prevention by millions of patients on a daily basis. Previous studies suggested that aspirin intake at bedtime reduces blood pressure compared with intake on awakening. This has never been studied in patients with CVD. Moreover, platelet reactivity and CVD incidence is highest during morning hours. Bedtime aspirin intake may attenuate morning platelet reactivity. This clinical trial examined the effect of bedtime aspirin intake compared with intake on awakening on 24-hour ambulatory blood pressure measurement and morning platelet reactivity in patients using aspirin for CVD prevention. In this randomized open-label crossover trial, 290 patients were randomized to take 100 mg aspirin on awakening or at bedtime during 2 periods of 3 months. At the end of each period, 24-hour blood pressure and morning platelet reactivity were measured. The primary analysis population comprised 263 (blood pressure) and 133 (platelet reactivity) patients. Aspirin intake at bedtime did not reduce blood pressure compared with intake on awakening (difference systolic/diastolic: -0.1 [95% confidence interval, -1.0, 0.9]/-0.6 [95% confidence interval, -1.2, 0.0] mm Hg). Platelet reactivity during morning hours was reduced with bedtime aspirin intake (difference: -22 aspirin reaction units [95% confidence interval, -35, -9]). The intake of low-dose aspirin at bedtime compared with intake on awakening did not reduce blood pressure of patients with CVD. However, bedtime aspirin reduced morning platelet reactivity. Future studies are needed to assess the effect of this promising simple intervention on the excess of cardiovascular events during the high risk morning hours. © 2015 American Heart Association, Inc.

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

    Science.gov (United States)

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

    2017-10-30

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

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

    Science.gov (United States)

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

    2015-01-01

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

  13. Impact of self-assessment questions and learning styles in Web-based learning: a randomized, controlled, crossover trial.

    Science.gov (United States)

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

    2006-03-01

    To determine the effect of self-assessment questions on learners' knowledge and format preference in a Web-based course, and investigate associations between learning styles and outcomes. The authors conducted a randomized, controlled, crossover trial in the continuity clinics of the Mayo-Rochester internal medicine residency program during the 2003-04 academic year. Case-based self-assessment questions were added to Web-based modules covering topics in ambulatory internal medicine. Participants completed two modules with questions and two modules without questions, with sequence randomly assigned. Outcomes included knowledge assessed after each module, format preference, and learning style assessed using the Index of Learning Styles. A total of 121 of 146 residents (83%) consented. Residents had higher test scores when using the question format (mean +/- standard error, 78.9% +/- 1.0) than when using the standard format (76.2% +/- 1.0, p = .006). Residents preferring the question format scored higher (79.7% +/- 1.1) than those preferring standard (69.5% +/- 2.3, p 3.0, p = .003 and p = .033, respectively). Sixty-five of 78 residents (83.3%, 95% CI 73.2-90.8%) preferred the question format. Learning styles were not associated with preference (p > .384). Although the question format took longer than the standard format (60.4 +/- 3.6 versus 44.3 +/- 3.3 minutes, p Web-based learning and "traditional" educational activities. Future research, in both Web-based learning and other teaching modalities, should focus on further defining the effectiveness of selected instructional methods in specific learning contexts.

  14. 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.

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

    Directory of Open Access Journals (Sweden)

    Ramin Mehrdad

    2015-10-01

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

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

    Science.gov (United States)

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

    2014-05-28

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

  17. Bilateral compared with unilateral sacral nerve stimulation for faecal incontinence: results of a randomized, single-blinded crossover study.

    Science.gov (United States)

    Duelund-Jakobsen, J; Buntzen, S; Lundby, L; Sørensen, M; Laurberg, S

    2015-12-01

    This randomized single-blinded crossover study aimed to investigate whether bilateral sacral nerve stimulation (SNS) is more efficient than unilateral stimulation for faecal incontinence (FI). Patients with FI who responded during a unilateral test stimulation, with a minimum improvement of 50% were eligible. Twenty-seven patients who were accepted to enter the trial were bilaterally implanted with two permanent leads and pacemakers. Patients were randomized into three periods of 4 weeks' stimulation including unilateral right, unilateral left and bilateral stimulation. Symptoms scores and bowel habit diaries were collected at baseline and in each study period. A 1-week washout was introduced between each study period. Twenty-seven (25 female) patients with a median age of 63 (36-84) years were bilaterally implanted from May 2009 to June 2012. The median number of episodes of FI per 3 weeks significantly decreased from 17 (3-54) at baseline to 2 (0-20) during stimulation on the right side, 2 (0-42) during stimulation on the left side and 1 (0-25) during bilateral stimulation. The Wexner incontinence score improved significantly from a median of 16 (10-20) at baseline to 9 (0-14) with right-side stimulation, 10 (0-15) with left-side stimulation and 9 (0-14) with bilateral stimulation. The differences between unilateral right or unilateral left and bilateral stimulation were non-significant, for FI episodes (P = 0.3) or for Wexner incontinence score (P = 0.9). Bilateral SNS therapy for FI is not superior to standard unilateral stimulation in the short term. Equal functional results can be obtained regardless of the side of implantation. Colorectal Disease © 2015 The Association of Coloproctology of Great Britain and Ireland.

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

    Directory of Open Access Journals (Sweden)

    Maria-Elena Planas

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

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

    Directory of Open Access Journals (Sweden)

    Martin Niedermeier

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

  20. General immunity and superadditivity of two-way Gaussian quantum cryptography.

    Science.gov (United States)

    Ottaviani, Carlo; Pirandola, Stefano

    2016-03-01

    We consider two-way continuous-variable quantum key distribution, studying its security against general eavesdropping strategies. Assuming the asymptotic limit of many signals exchanged, we prove that two-way Gaussian protocols are immune to coherent attacks. More precisely we show the general superadditivity of the two-way security thresholds, which are proven to be higher than the corresponding one-way counterparts in all cases. We perform the security analysis first reducing the general eavesdropping to a two-mode coherent Gaussian attack, and then showing that the superadditivity is achieved by exploiting the random on/off switching of the two-way quantum communication. This allows the parties to choose the appropriate communication instances to prepare the key, accordingly to the tomography of the quantum channel. The random opening and closing of the circuit represents, in fact, an additional degree of freedom allowing the parties to convert, a posteriori, the two-mode correlations of the eavesdropping into noise. The eavesdropper is assumed to have no access to the on/off switching and, indeed, cannot adapt her attack. We explicitly prove that this mechanism enhances the security performance, no matter if the eavesdropper performs collective or coherent attacks.

  1. Optimal chest compression rate in cardiopulmonary resuscitation: a prospective, randomized crossover study using a manikin model.

    Science.gov (United States)

    Lee, Seong Hwa; Ryu, Ji Ho; Min, Mun Ki; Kim, Yong In; Park, Maeng Real; Yeom, Seok Ran; Han, Sang Kyoon; Park, Seong Wook

    2016-08-01

    When performing cardiopulmonary resuscitation (CPR), the 2010 American Heart Association guidelines recommend a chest compression rate of at least 100 min, whereas the 2010 European Resuscitation Council guidelines recommend a rate of between 100 and 120 min. The aim of this study was to examine the rate of chest compression that fulfilled various quality indicators, thereby determining the optimal rate of compression. Thirty-two trainee emergency medical technicians and six paramedics were enrolled in this study. All participants had been trained in basic life support. Each participant performed 2 min of continuous compressions on a skill reporter manikin, while listening to a metronome sound at rates of 100, 120, 140, and 160 beats/min, in a random order. Mean compression depth, incomplete chest recoil, and the proportion of correctly performed chest compressions during the 2 min were measured and recorded. The rate of incomplete chest recoil was lower at compression rates of 100 and 120 min compared with that at 160 min (P=0.001). The numbers of compressions that fulfilled the criteria for high-quality CPR at a rate of 120 min were significantly higher than those at 100 min (P=0.016). The number of high-quality CPR compressions was the highest at a compression rate of 120 min, and increased incomplete recoil occurred with increasing compression rate. However, further studies are needed to confirm the results.

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

    Science.gov (United States)

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

    2018-01-12

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

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

    Science.gov (United States)

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

    2004-01-01

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

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

    Science.gov (United States)

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

    2017-09-01

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

  5. Interprofessional Communication of Clinicians Using a Mobile Phone App: A Randomized Crossover Trial Using Simulated Patients.

    Science.gov (United States)

    Patel, Bhavesh; Johnston, Maximilian; Cookson, Natalie; King, Dominic; Arora, Sonal; Darzi, Ara

    2016-04-06

    Most hospitals use paging systems as the principal communication system, despite general dissatisfaction by end users. To this end, we developed an app-based communication system (called Hark) to facilitate and improve the quality of interpersonal communication. The objectives of our study were (1) to assess the quality of information transfer using pager- and app-based (Hark) communication systems, (2) to determine whether using mobile phone apps for escalation of care results in additional delays in communication, and (3) to determine how end users perceive mobile phone apps as an alternative to pagers. We recruited junior (postgraduate year 1 and 2) doctors and nurses from a range of specialties and randomly assigned them to 2 groups who used either a pager device or the mobile phone-based Hark app. We asked nurses to hand off simulated patients while doctors were asked to receive handoff information using these devices. The quality of information transfer, time taken to respond to messages, and users' satisfaction with each device was recorded. Each participant used both devices with a 2-week washout period in between uses. We recruited 22 participants (13 nurses, 9 doctors). The quality of the referrals made by nurses was significantly better when using Hark (Hark median 118, range 100-121 versus pager median 77, range 39-104; P=.001). Doctors responded to messages using Hark more quickly than when responding to pagers, although this difference was not statistically significant (Hark mean 86.6 seconds, SD 96.2 versus pager mean 136.5 seconds, SD 201.0; P=.12). Users rated Hark as significantly better on 11 of the 18 criteria of an information transfer device (PHark improved the quality of transfer of information about simulated patients and was rated by users as more effective and efficient, and less distracting than pagers. Using this device did not result in delay in patient care.

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

    Directory of Open Access Journals (Sweden)

    Franciele R Figueira

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

  7. Upper airway stabilization by osteopathic manipulation of the sphenopalatine ganglion versus sham manipulation in OSAS patients: a proof-of-concept, randomized, crossover, double-blind, controlled study

    OpenAIRE

    Jacq , Olivier; Arnulf , Isabelle; Similowski , Thomas; Attali , Valérie

    2017-01-01

    Background Osteopathic manipulative treatment (OMT) of the sphenopalatine ganglion (SPG) is used empirically for the treatment of rhinitis and snoring and is thought to increase pharyngeal stability. This trial was designed to study the effects of this treatment on pharyngeal stability evaluated by critical closing pressure in obstructive sleep apnoea syndrome. Methods This single-centre, randomized, crossover, double-blind study compared active manipulation and sham manipulation of the SPG. ...

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

    DEFF Research Database (Denmark)

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

    1996-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Friis AL

    2017-06-01

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

  10. Lexical need as a two-way reality cognition tool

    Directory of Open Access Journals (Sweden)

    Mark Kit

    2014-09-01

    Full Text Available Lexical need as a two-way reality cognition tool In this paper a concept of lexical need is introduced and its application in research of cognitive aspects of translation is discussed. Further discussion elaborates mechanisms of development of translator’s lexical space in the course of translation. Authors discuss the importance and special nature of low-frequency lexical units and difficulties encountered when studying their usage and suggest that the lexical need concept help these studies. Lexical need analysis can be also used to learn specifics of translator’s lexical space and then to take measures for selection of translators and improvement of their skills.

  11. Improve the teaching quality by two-way education mode

    Directory of Open Access Journals (Sweden)

    Hongyan Shi

    2017-02-01

    Full Text Available Teaching activities contain teaching and learning, and both teachers and students have to work hard to improve the quality of teaching. This essay introduced the basic conception of “two-way and five-ring” mode first, and expatiated on the structure of this mode. The author used her own experiences to combine the teaching mode with the real situation of military school, emphasized teaching itself and talked about some spe-cific plans. This will give a certain extend help in improving the quality of teaching in military school.

  12. Two-way communication promote value-added services

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-06-01

    This article reviews a number of developments in the efforts of electric utilities to establish two-way communications with their customers in order to develop products and services to fit each customer`s needs. In their efforts, utilities are facing an array of technology, including broadband, radio frequency, cellular, satellite, dial inbound, and power line carrier current. Individual efforts with each technology are noted. In many cases, the utilities are finding that existing cable and telephone companies are powerful allies in their efforts. Finding that their technology is marketable, the electric utilities are also diversifying horizontally and marketing their communications tools to other, both inside and outside of the utility industry.

  13. Two-way radios and scanners for dummies

    CERN Document Server

    Silver, H Ward

    2013-01-01

    Discover a fun new hobby with helpful possibilities Get directions, talk to folks overseas, or find out whether the fish are biting Want to check out the morning news in London, help out in emergencies, or tune in to the big race? Two-way radios open up a world of possibilities - literally. This handy guide tells you about the equipment you need, fills you in on radio etiquette, shows you how to stay legal, and gives you lots of cool ideas for family-friendly radio activities. Discover how to * Use the right radio lingo * Choose and operate different types of radios * Get a license if you n

  14. Immediate acid-suppressing effects of ranitidine hydrochloride and rabeprazole sodium following initial administration and reintroduction: A randomized, cross-over study using wireless pH monitoring capsules.

    Science.gov (United States)

    Ono, Shouko; Kato, Mototsugu; Ono, Yuji; Imai, Aki; Yoshida, Takeshi; Shimizu, Yuichi; Asaka, Masahiro

    2009-04-01

    Histamine 2 receptor antagonists and proton-pump inhibitors, drugs that are widely used for the treatment of acid-related diseases, have different clinical characteristics. The objective of this study was to compare the acid-suppressing effects of ranitidine hydrochloride and those of rabeprazole sodium at the first administration and re-administration after withdrawal. The study was designed as an open-label, randomized, two-way cross-over trial. Seven Helicobacter pylori-negative healthy volunteers were enrolled in this study. Ranitidine hydrochloride (300 mg/day) or rabeprazole sodium (20 mg/day) was administered from days 1 to 7 and from days 11 to 13. The percentage of time with gastric pH sodium maintained a potent and stable effect from days 2 to 7 (ranitidine vs rabeprazole: P hydrochloride was attenuated after day 4. In addition, the effect of ranitidine hydrochloride at re-administration was attenuated (days 11, 12, and 13 vs pre-administration: not significant). In view of our observations, we expect symptoms associated with gastric acidity to be more adequately controlled with rabeprazole sodium in the short term when compared to ranitidine hydrochloride.

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

    Directory of Open Access Journals (Sweden)

    Leila Valizadeh

    2017-06-01

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

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

    Science.gov (United States)

    Safarinejad, Mohammad Reza

    2005-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Considine Robert V

    2011-01-01

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

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

    Science.gov (United States)

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

    2017-10-04

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

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

    Science.gov (United States)

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

    2017-06-01

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

  20. Effect of almonds on insulin secretion and insulin resistance in nondiabetic hyperlipidemic subjects: a randomized controlled crossover trial.

    Science.gov (United States)

    Jenkins, David J A; Kendall, Cyril W C; Marchie, Augustine; Josse, Andrea R; Nguyen, Tri H; Faulkner, Dorothea A; Lapsley, Karen G; Singer, William

    2008-07-01

    Nuts appear to have a marked effect in cohort studies in reducing the risk of coronary heart disease (CHD), but their demonstrated ability to lower cholesterol can only explain a proportion of the reduction in risk. Our aim was to assess whether improvement in carbohydrate metabolism provides a further explanation for the effect of nuts in reducing CHD. The effects of whole almonds, taken as snacks, were compared with the effects of low saturated fat (<5% energy) whole-wheat muffins (control) in the therapeutic diets of hyperlipidemic subjects. In a randomized crossover study, 27 hyperlipidemic men and women consumed 3 isoenergetic (mean, 423 kcal/d) supplements each for 1 month. Supplements provided 22.2% of energy and consisted of full-dose almonds (73 +/- 3 g/d), half-dose almonds plus half-dose muffins, and full-dose muffins. Subjects were assessed at weeks 0, 2, and 4 and fasting blood samples were obtained. Twenty-four-hour urinary output was collected at the end of week 4 on each treatment. Mean body weights differed by less than 300 g between treatments. No differences were seen in baseline or treatment values for fasting glucose, insulin, C-peptide, or insulin resistance as measured by homeostasis model assessment of insulin resistance. However, 24-hour urinary C-peptide output as a marker of 24-hour insulin secretion was significantly reduced on the half-and full-dose almonds by comparison to the control after adjustment for urinary creatinine output (P = .002 and P = .004, respectively). We conclude that reductions in 24-hour insulin secretion appear to be a further metabolic advantage of nuts that in the longer term may help to explain the association of nut consumption with reduced CHD risk.

  1. Validation and Reliability of a Smartphone Application for the International Prostate Symptom Score Questionnaire: A Randomized Repeated Measures Crossover Study

    Science.gov (United States)

    Shim, Sung Ryul; Sun, Hwa Yeon; Ko, Young Myoung; Chun, Dong-Il; Yang, Won Jae

    2014-01-01

    Background Smartphone-based assessment may be a useful diagnostic and monitoring tool for patients. There have been many attempts to create a smartphone diagnostic tool for clinical use in various medical fields but few have demonstrated scientific validity. Objective The purpose of this study was to develop a smartphone application of the International Prostate Symptom Score (IPSS) and to demonstrate its validity and reliability. Methods From June 2012 to May 2013, a total of 1581 male participants (≥40 years old), with or without lower urinary tract symptoms (LUTS), visited our urology clinic via the health improvement center at Soonchunhyang University Hospital (Republic of Korea) and were enrolled in this study. A randomized repeated measures crossover design was employed using a smartphone application of the IPSS and the conventional paper form of the IPSS. Paired t test under a hypothesis of non-inferior trial was conducted. For the reliability test, the intraclass correlation coefficient (ICC) was measured. Results The total score of the IPSS (P=.289) and each item of the IPSS (P=.157-1.000) showed no differences between the paper version and the smartphone version of the IPSS. The mild, moderate, and severe LUTS groups showed no differences between the two versions of the IPSS. A significant correlation was noted in the total group (ICC=.935, Psmartphones could participate. Conclusions The validity and reliability of the smartphone application version were comparable to the conventional paper version of the IPSS. The smartphone application of the IPSS could be an effective method for measuring lower urinary tract symptoms. PMID:24513507

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

    Science.gov (United States)

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

    2017-11-01

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

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

    Directory of Open Access Journals (Sweden)

    Bartko Johann

    2011-06-01

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

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

    Directory of Open Access Journals (Sweden)

    Donna M. Winham

    2017-10-01

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

  5. Solithromycin, a novel macrolide, does not prolong cardiac repolarization: a randomized, three-way crossover study in healthy subjects.

    Science.gov (United States)

    Darpo, Borje; Sager, Philip T; Fernandes, Prabhavathi; Jamieson, Brian D; Keedy, Kara; Zhou, Meijian; Oldach, David

    2017-02-01

    Macrolide antibiotics may cause QT prolongation. To study the QT effect of a novel macrolide, solithromycin. This was a thorough QT study with a three-way crossover design performed in healthy male and female subjects to evaluate the ECG effects of a novel macrolide, solithromycin. Forty-eight subjects were randomized to receive 800 mg of intravenous (iv) solithromycin, 400 mg of oral moxifloxacin and placebo in three separate treatment periods. Continuous 12 lead ECGs were recorded at a pre-dose baseline and serially after drug administration for 24 h. After the 40 min infusion of 800 mg of solithromycin, the geometric mean solithromycin peak plasma concentration (C max ) reached 5.9 (SD: 1.30) μg/mL. Solithromycin infusion caused a heart rate increase with a peak effect of 15 bpm immediately after the end of the infusion. The change-from-baseline QTcF (ΔQTcF) was similar after dosing with solithromycin and placebo and the resulting placebo-corrected ΔQTcF (ΔΔQTcF) for solithromycin was therefore small at all timepoints with a peak effect at 4 h of only 2.8 ms (upper bound of the 90% CI: 4.9 ms). Using a linear exposure-response model, a statistically significant, slightly negative slope of -0.86 ms per ng/mL (90% CI: -1.19 to -0.53; P = 0.0001) was observed with solithromycin. The study's ability to detect small QT changes was confirmed by the moxifloxacin response. Solithromycin did not have a clinically meaningful effect on the PR or QRS interval. The study demonstrated that solithromycin, unlike other macrolide antibiotics, does not cause QT prolongation. © The Author 2016. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  6. Skipping breakfast reduces energy intake and physical activity in healthy women who are habitual breakfast eaters: A randomized crossover trial.

    Science.gov (United States)

    Yoshimura, Eiichi; Hatamoto, Yoichi; Yonekura, Satomi; Tanaka, Hiroaki

    2017-05-15

    Many epidemiological studies indicate a positive relationship between skipping breakfast (SB) and obesity. However, it is unclear whether SB affects energy intake and physical activity during the day. The objective of the present study was to evaluate the acute effects of SB on energy intake and physical activity under free-living conditions. The present study used a randomized, crossover trial design comparing eating breakfast (EB) and SB days. Twenty lean, healthy women 21-25years old who were habitual breakfast eaters (≥5daysperweek) took part in this study. On EB days, participants were provided a standard breakfast (542kcal). The meals and physical activity after breakfast were under free-living conditions. The meals consisted of foods available at supermarkets, restaurants, and convenience stores. Dietary intake was evaluated by adding values from food labels. Physical activity was assessed using a tri-axial accelerometer. Energy intake at lunch was significantly increased after SB compared with EB (+131±188kcal; p=0.0057). Total energy intake per day was significantly lower after SB compared with EB (-262±428kcal, p=0.013). Physical activity energy expenditure was slightly lower after SB compared with EB (-41±75kcal in the morning, p=0.024; -56±129kcalperday, p=0.064). Step counts and time spent physically active over the whole day were not significantly different between conditions. Skipping breakfast reduced energy intake during the day and morning physical activity in healthy women who were habitual breakfast eaters. The decreased energy expenditure related to physical activity after SB did not exceed the decreased energy intake. Copyright © 2017 Elsevier Inc. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Dean Michael

    2012-10-01

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

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

    Science.gov (United States)

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

    2012-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Martin de Bock

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

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

    Science.gov (United States)

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

    2012-05-01

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

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

    Science.gov (United States)

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

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

  12. Alcohol increases homocysteine and reduces B vitamin concentration in healthy male volunteers--a randomized, crossover intervention study.

    Science.gov (United States)

    Gibson, A; Woodside, J V; Young, I S; Sharpe, P C; Mercer, C; Patterson, C C; McKinley, M C; Kluijtmans, L A J; Whitehead, A S; Evans, A

    2008-11-01

    Few studies have examined the effect of alcohol consumption on total homocysteine (tHcy) concentrations. To assess the effect of an 8-week intervention with vodka or red wine on plasma tHcy and B vitamin concentrations in healthy male volunteers. To assess the effect on tHcy according to methylenetetrahydrofolate reductase (MTHFR) 677C>T genotype. A randomized controlled crossover intervention study measuring tHcy and serum folate and vitamin B(12) concentrations was conducted in 78 male subjects (21-70 years). Following a 2-week washout period during which no alcohol was consumed, all subjects consumed 24 g alcohol (either 240 ml red wine or 80 ml vodka)/day for a 2-week period. Following a further 2-week washout, participants consumed the alternate intervention for 2 weeks. A significant increase in plasma tHcy was observed after the 2-week red wine intervention (5%, P = 0.03), and a non-significant increase in tHcy with vodka intervention (3%, P = 0.09). When the two interventions were compared, the change in tHcy did not differ between the vodka and red wine interventions (P = 0.57). There were significant decreases in serum vitamin B(12) and folate concentrations, and this decrease did not differ between interventions. The increase in tHcy observed in both interventions did not vary by MTHFR 677C>T genotype. A 2-week alcohol intervention resulted in a decrease in folate and vitamin B(12) status and an increase in plasma tHcy. The effect of alcohol intervention on tHcy, folate and vitamin B(12) concentrations did not differ between the red wine and vodka intervention groups.

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

    Directory of Open Access Journals (Sweden)

    Goldstein Brahm

    2012-01-01

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

  14. 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.

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

    Science.gov (United States)

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

    2015-07-01

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

  16. An improved two-way continuous-variable quantum key distribution protocol with added noise in homodyne detection

    International Nuclear Information System (INIS)

    Sun Maozhu; Peng Xiang; Guo Hong

    2013-01-01

    We propose an improved two-way continuous-variable quantum key distribution (CV QKD) protocol by adding proper random noise on the receiver’s homodyne detection, the security of which is analysed against general collective attacks. The simulation result under the collective entangling cloner attack indicates that despite the correlation between two-way channels decreasing the secret key rate relative to the uncorrelated channels slightly, the performance of the two-way protocol is still far beyond that of the one-way protocols. Importantly, the added noise in detection is beneficial for the secret key rate and the tolerable excess noise of this two-way protocol. With the reasonable reconciliation efficiency of 90%, the two-way CV QKD with added noise allows the distribution of secret keys over 60 km fibre distance. (paper)

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

    Science.gov (United States)

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

    2013-11-01

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

  18. Two-Way Communication with a Single Quantum Particle

    Science.gov (United States)

    Del Santo, Flavio; Dakić, Borivoje

    2018-02-01

    In this Letter we show that communication when restricted to a single information carrier (i.e., single particle) and finite speed of propagation is fundamentally limited for classical systems. On the other hand, quantum systems can surpass this limitation. We show that communication bounded to the exchange of a single quantum particle (in superposition of different spatial locations) can result in "two-way signaling," which is impossible in classical physics. We quantify the discrepancy between classical and quantum scenarios by the probability of winning a game played by distant players. We generalize our result to an arbitrary number of parties and we show that the probability of success is asymptotically decreasing to zero as the number of parties grows, for all classical strategies. In contrast, quantum strategy allows players to win the game with certainty.

  19. Overlay cognitive radio systems with adaptive two-way relaying

    KAUST Repository

    Hyadi, Amal

    2013-12-01

    In this paper, we propose a spectrum sharing mechanism with a two-phase two-way relaying protocol for an overlay cognitive network. The system comprises two primary users (PUs) and two secondary users (SUs). One of the SUs acts as a relay for the PUs and gains spectrum sharing as long as he respects outage probability constraints of the primary system. Moreover, we consider that the relaying node performs an optimal power allocation scheme that minimizes the outage performance of the secondary receiver. Closed form expressions for the outage probability are derived for the cases of Decode-and-Forward (DF), Amplify-and-Forward (AF), and adaptive relaying. Numerical simulations are presented to illustrate and compare the obtained results. © 2013 IEEE.

  20. Two-Way Communication Using RFID Equipment and Techniques

    Science.gov (United States)

    Jedry, Thomas; Archer, Eric

    2007-01-01

    Equipment and techniques used in radio-frequency identification (RFID) would be extended, according to a proposal, to enable short-range, two-way communication between electronic products and host computers. In one example of a typical contemplated application, the purpose of the short-range radio communication would be to transfer image data from a user s digital still or video camera to the user s computer for recording and/or processing. The concept is also applicable to consumer electronic products other than digital cameras (for example, cellular telephones, portable computers, or motion sensors in alarm systems), and to a variety of industrial and scientific sensors and other devices that generate data. Until now, RFID has been used to exchange small amounts of mostly static information for identifying and tracking assets. Information pertaining to an asset (typically, an object in inventory to be tracked) is contained in miniature electronic circuitry in an RFID tag attached to the object. Conventional RFID equipment and techniques enable a host computer to read data from and, in some cases, to write data to, RFID tags, but they do not enable such additional functions as sending commands to, or retrieving possibly large quantities of dynamic data from, RFID-tagged devices. The proposal would enable such additional functions. The figure schematically depicts an implementation of the proposal for a sensory device (e.g., a digital camera) that includes circuitry that converts sensory information to digital data. In addition to the basic sensory device, there would be a controller and a memory that would store the sensor data and/or data from the controller. The device would also be equipped with a conventional RFID chipset and antenna, which would communicate with a host computer via an RFID reader. The controller would function partly as a communication interface, implementing two-way communication protocols at all levels (including RFID if needed) between the

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

    Science.gov (United States)

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

    2018-01-01

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

  2. The Effect of Facilitated Tucking during Endotracheal Suctioning on Procedural Pain in Preterm Neonates: A Randomized Controlled Crossover Study

    Science.gov (United States)

    Alinejad-Naeini, Mona; Mohagheghi, Parisa; Peyrovi, Hamid; Mehran, Abbas

    2014-01-01

    Background: Premature infants not only feel and understand the pain, but also respond more intensively compared with term infants. Non-pharmacological methods of pain control are suitable to relieve pain in painful procedures. The facilitated tucking position is considered as a non-pharmacological method of pain control in infants; however, its impact on frequent and repeated procedural pain such as endotracheal suctioning remains to be studied. Objectives: This paper is the report of a study that examined the impact of facilitated tucking position on behavioral pain during suctioning in premature neonates. Design: This was a clinical trial study with a crossover design. Settings: The study was conducted in a level II Neonatal Intensive Care Unit, located in a teaching hospital, affiliated to Tehran University of Medical Sciences, Tehran, Iran. Participants: Thirty four infants were enrolled in this study based on the following inclusion criteria: age between 29 to 37 weeks of gestational age, birth weight 1200 grams or more, having an endotracheal tube, no congenital anomalies, no seizures diagnosis, no chest tubes, no intracranial hemorrhage higher than degree II, not receiving opiates and sedatives four hours before intervention and not receiving any painful procedure at least half an hour before the intervention. Methods: The samples were randomly received a sequence of suctioning with/without or suctioning without/with facilitated tucking. Preterm Infant Pain Profile (PIPP) was used to collect the data. SPSS version 16.0 for Windows (SPSS Inc., Chicago, IL, USA) was used for statistical analysis. Results: While 38.2% of infants experienced severe pain during suctioning without intervention, only 8.8% of them experienced severe pain during suctioning with intervention. The results of the paired t-test show that there is a statistically significant difference in the mean scores of pain between non-intervention and intervention cases (ppain score substantially

  3. The effect of facilitated tucking during endotracheal suctioning on procedural pain in preterm neonates: a randomized controlled crossover study.

    Science.gov (United States)

    Alinejad-Naeini, Mona; Mohagheghi, Parisa; Peyrovi, Hamid; Mehran, Abbas

    2014-05-04

    Premature infants not only feel and understand the pain, but also respond more intensively compared with term infants. Non-pharmacological methods of pain control are suitable to relieve pain in painful procedures. The facilitated tucking position is considered as a non-pharmacological method of pain control in infants; however, its impact on frequent and repeated procedural pain such as endotracheal suctioning remains to be studied. This paper is the report of a study that examined the impact of facilitated tucking position on behavioral pain during suctioning in premature neonates. This was a clinical trial study with a crossover design. The study was conducted in a level II Neonatal Intensive Care Unit, located in a teaching hospital, affiliated to Tehran University of Medical Sciences, Tehran, Iran. Thirty four infants were enrolled in this study based on the following inclusion criteria: age between 29 to 37 weeks of gestational age, birth weight 1200 grams or more, having an endotracheal tube, no congenital anomalies, no seizures diagnosis, no chest tubes, no intracranial hemorrhage higher than degree II, not receiving opiates and sedatives four hours before intervention and not receiving any painful procedure at least half an hour before the intervention. The samples were randomly received a sequence of suctioning with/without or suctioning without/with facilitated tucking. Preterm Infant Pain Profile (PIPP) was used to collect the data. SPSS version 16.0 for Windows (SPSS Inc., Chicago, IL, USA) was used for statistical analysis. While 38.2% of infants experienced severe pain during suctioning without intervention, only 8.8% of them experienced severe pain during suctioning with intervention. The results of the paired t-test show that there is a statistically significant difference in the mean scores of pain between non-intervention and intervention cases (p pain score substantially reduced in cases with intervention. Given the multiplicity of endotracheal

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

    Science.gov (United States)

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

    2018-01-08

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

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

    Directory of Open Access Journals (Sweden)

    Hanna Fernemark

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

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

    Science.gov (United States)

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

    2016-10-01

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

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

    Science.gov (United States)

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

    2013-01-01

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

  8. The two way memory effect in TiNi alloys

    Energy Technology Data Exchange (ETDEWEB)

    Filip, P.; Mazanec, K. [Technical Univ. of Ostrava (Czech Republic). Inst. of Materials Engineering

    1996-08-01

    The two way memory effect (TWME) in shape memory alloys represents a reversible spontaneous shape changes during cooling and heating processes. This is a consequence of reversible phase transformations observed without application of any external stresses. The TWME is usually obtained after a thermomechanical treatment often called training. The different opinions were published concerning the influence of R-phase formation in TiNi based alloys on the stability of TWME. Stachowiak and McCormick have stated that the formation of R-phase diminishes the extent of obtained reversible strain as well as the stability of TWME. In contrast to this conclusion, the authors observed enhanced stability of TWME in the cases when the R-phase formation precedes the martensitic transformation B2 {yields} B19{prime}. Repeating the heating cycles at loading of the memory materials, the complex degradation mechanisms of TiNi alloys occurs. The dislocation generation in the matrix of TiNi alloys (work hardening) strongly influences the maximum level of generated stresses and the extent of reversible strain. As a contribution to the explanation of physical principles of TWME, the present paper is devoted to the study of substructure after so called hard training at which the specimens are deformed ({var_epsilon} = 4%) and cyclically heated and cooled down at constrained conditions.

  9. 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

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

    Science.gov (United States)

    Kim, Myoung Kwon; Shin, Young Jun

    2017-11-21

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

  11. Reliability - Based Design of Reinforced Concrete Two-Way Solid ...

    African Journals Online (AJOL)

    In this work, a FORTRAN-based computer program was developed to aid the design of reinforced concrete slabs to Eurocode 2 (EC 2)[1]design requirements at constant reliability levels using First Order Reliability Method (FORM).The design variables for the design of the slab were considered random with safety indices ...

  12. Single-dose, randomized crossover comparisons of different-strength imatinib mesylate formulations in healthy Korean male subjects.

    Science.gov (United States)

    Kim, Kyoung-Ah; Park, Shin Jung; Kim, Chin; Park, Ji-Young

    2013-10-01

    Imatinib mesylate is used to treat chronic myeloid leukemia and advanced gastrointestinal stromal tumors. The purpose of this study was to compare the pharmacokinetics of 2 different strengths of the imatinib formulation containing 100 mg (reference) and 400 mg (test) to satisfy the regulatory requirement for marketing. A single-center, randomized, single-dose, open-label, 2-period, 2-sequence, comparative crossover study with a 14-day washout period was conducted in 30 healthy male volunteers. Plasma samples for the drug analysis were collected up to 72 hours after drug treatment. Participants received either the reference (4 tablets of 100-mg imatinib) or the test (1 tablet of 400-mg imatinib) formulation during the first period and the alternative formulation during the second period. The safety profiles and tolerability of the 2 formulations were also assessed based on physical examinations, laboratory tests, a 12-lead ECG, and vital signs. Thirty participants were initially enrolled; their mean (SD) age, height, weight, and body mass index were 24.9 (2.0) years (range, 23-30 years), 174 (5) cm (range, 164-185 cm), 69.9 (2.0) kg (range, 54.1-87.4 kg), and 23.0 (2.0) kg/m(2) (range, 18.5-26.9 kg/m(2)); 28 healthy participants completed both treatment periods. Two subjects did not complete the study because they withdrew consent for personal reasons. The observed mean (SD) Cmax, AUC0-last, and AUC0-∞ values for the reference formulation were 1792 (357) ng/mL, 28,485 (6274) ng · h/mL, and 29,079 (6371) ng · h/mL, respectively. Corresponding values for the test formulation were 1710 (312) ng/mL, 27,222 (4624) ng · h/mL , and 27,872 (4751) ng · h/mL. The geometric mean ratios (90% CIs) between the 2 formulations at the 400-mg dose of imatinib were 0.9579 (0.9054-1.0136) for Cmax, 0.9652 (0.9174-1.0155) for AUC0-last, and 0.9679 (0.9203-1.0179) for AUC0-∞, respectively. During the study period, 6 adverse events (3 for the reference and 3 for the test

  13. 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

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

    Directory of Open Access Journals (Sweden)

    Vincent Souday

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

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

    Science.gov (United States)

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

    2016-01-01

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

  16. The Application of One-Hour Static Qigong Program to Decrease Needle Pain of Korean Adolescents With Type 1 Diabetes: A Randomized Crossover Design.

    Science.gov (United States)

    Kim, Euiyeon; Lee, Ji-Eun; Sohn, Min

    2017-10-01

    The aim of this study was to describe application of a static Qigong program to decrease needle pain in Korean adolescents with type 1 diabetes and its pilot test results. The pilot study was a randomized crossover design including 26 adolescents randomized to Qigong or rest group. Participants received a 60-minute Qigong program consisted of warm up, deep breathing, imaginary, and a closing warm up. After 24-hour washout period, treatment assignments were switched. We collected before and after intervention using a self-administered questionnaire, which included the faces pain scale to assess expected and perceived pain during blood sugar testing and insulin injection and the Positive and Negative Affect Schedule. Only expected pain on insulin injection was significantly lower after intervention ( P = .025). The results suggested that the devised static Qigong program was feasible intervention to decrease at least expected pain on insulin injection of adolescents with type 1 diabetes.

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

    Directory of Open Access Journals (Sweden)

    Rita R Alloway

    2017-11-01

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

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

    Science.gov (United States)

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

    2015-04-01

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

  19. Mental symptoms and drug use in maintenance treatment with slow-release oral morphine compared to methadone: results of a randomized crossover study.

    Science.gov (United States)

    Verthein, Uwe; Beck, Thilo; Haasen, Christian; Reimer, Jens

    2015-01-01

    Opioid maintenance treatment is the option of choice to stabilize opioid-dependent patients. Whilst efficacy of methadone and buprenorphine has been studied extensively, fewer data on slow-release oral morphine are available. This study analyzes the effects of slow-release oral morphine compared to methadone with regard to self-reported mental symptoms, drug use and satisfaction with treatment. The study was carried out as an open-label randomized crossover trial in 14 treatment sites in Switzerland and Germany. It comprised 2 crossover periods of 11 weeks each. For measuring mental symptoms, the Symptom Checklist-27 (SCL-27) was used. Drug and alcohol use was assessed by the number of consumption days, and treatment satisfaction by a visual analogue scale. A total of 157 patients were included for the analyses (per-protocol sample). Statistically significantly better outcomes for morphine as compared to methadone treatment were found for overall severity of mental symptoms (SCL-27 Global Severity Index), as well as 5 of the 6 syndrome groups of the SCL-27, and for treatment satisfaction. There were no statistically significant differences with regard to drug or alcohol use between groups. This study supports positive effects of slow-release oral morphine compared to methadone on patient-reported outcomes such as mental symptoms and treatment satisfaction with comparable effects on concomitant drug use. Slow-release oral morphine represents a meaningful alternative to methadone for treatment of opioid dependence. © 2014 S. Karger AG, Basel.

  20. Investigation of pedestrian crashes on two-way two-lane rural roads in Ethiopia.

    Science.gov (United States)

    Tulu, Getu Segni; Washington, Simon; Haque, Md Mazharul; King, Mark J

    2015-05-01

    Understanding pedestrian crash causes and contributing factors in developing countries is critically important as they account for about 55% of all traffic crashes. Not surprisingly, considerable attention in the literature has been paid to road traffic crash prediction models and methodologies in developing countries of late. Despite this interest, there are significant challenges confronting safety managers in developing countries. For example, in spite of the prominence of pedestrian crashes occurring on two-way two-lane rural roads, it has proven difficult to develop pedestrian crash prediction models due to a lack of both traffic and pedestrian exposure data. This general lack of available data has further hampered identification of pedestrian crash causes and subsequent estimation of pedestrian safety performance functions. The challenges are similar across developing nations, where little is known about the relationship between pedestrian crashes, traffic flow, and road environment variables on rural two-way roads, and where unique predictor variables may be needed to capture the unique crash risk circumstances. This paper describes pedestrian crash safety performance functions for two-way two-lane rural roads in Ethiopia as a function of traffic flow, pedestrian flows, and road geometry characteristics. In particular, random parameter negative binomial model was used to investigate pedestrian crashes. The models and their interpretations make important contributions to road crash analysis and prevention in developing countries. They also assist in the identification of the contributing factors to pedestrian crashes, with the intent to identify potential design and operational improvements. Copyright © 2015. Published by Elsevier Ltd.

  1. Pressure relief with visco-elastic foam or with combined static air overlay? A prospective, crossover randomized clinical trial in a dutch nursing home.

    Science.gov (United States)

    van Leen, Martin; Hovius, Steven; Halfens, Ruud; Neyens, Jacques; Schols, Jos

    2013-10-01

    Evidence of the best mattress for preventing pressure ulcers is not conclusive. In a single center, prospective, crossover trial on pressure ulcer incidence in nursing home residents, a static air overlay mattress, without a pump, on top of a visco-elastic foam mattress was compared with a visco-elastic foam mattress alone. The study was performed using a randomized crossover design. Forty-one patients with a score of 19 or lower on the Braden scale, but with no pressure ulcer at the start, were divided into 2 groups; 21 patients received a visco-elastic foam mattress (control group) and 20 patients a static air overlay on top of a visco-elastic foam mattress (intervention group) for a period of 6 months. In the second (crossover) period of 6 months, 19 patients participated in each group. Patients were checked weekly and, only when signs of development of a pressure ulcer were present was treatment altered to reposition patients according to the nursing home pressure ulcer protocol. No statistically significant differences were noted between the 2 groups with regard to age, gender, or Braden scale score. Of 41 patients, 3 died and were unable to participate in the crossover period, 8 patients (22.2%) developed a category 2 or higher pressure ulcer on a visco-elastic foam mattress (control group) and 2 (5.2%) on a static air mattress (intervention group)(P = 0.087). There was a difference regarding pressure ulcer incidence between patients with a very low Braden score between 6 and 12, and patients with a mean score between 13-19. Out of 8 patients, in the 2(25%) who developed a pressure ulcer on a foam mattress, the ulcers showed no signs of healing. In the static air group all pressure ulcers healed by normal treatment according to a standardized pressure ulcer treatment protocol. In this small study, static air overlay mattresses provided a better prevention than visco-elastic foam mattresses alone (5.2% vs 22.2%). The Braden scores of the patients in both

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

    DEFF Research Database (Denmark)

    Holm, Bente; Husted, Henrik; Kehlet, Henrik

    2012-01-01

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

  3. Individual eigenvalue distributions of crossover chiral random matrices and low-energy constants of SU(2) × U(1) lattice gauge theory

    Science.gov (United States)

    Yamamoto, Takuya; Nishigaki, Shinsuke M.

    2018-02-01

    We compute individual distributions of low-lying eigenvalues of a chiral random matrix ensemble interpolating symplectic and unitary symmetry classes by the Nyström-type method of evaluating the Fredholm Pfaffian and resolvents of the quaternion kernel. The one-parameter family of these distributions is shown to fit excellently the Dirac spectra of SU(2) lattice gauge theory with a constant U(1) background or dynamically fluctuating U(1) gauge field, which weakly breaks the pseudoreality of the unperturbed SU(2) Dirac operator. The observed linear dependence of the crossover parameter with the strength of the U(1) perturbations leads to precise determination of the pseudo-scalar decay constant, as well as the chiral condensate in the effective chiral Lagrangian of the AI class.

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

    DEFF Research Database (Denmark)

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

    2008-01-01

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

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

    DEFF Research Database (Denmark)

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

    2016-01-01

    Background: Farmers' risk of pesticide poisoning can be reduced with personal protective equipment but in low-income countries farmers' use of such equipment is limited. Objective: To examine the effectiveness and efficiency of Locally Adapted Personal Protective Equipment to reduce organophosphate...... exposure among farmers. Methods: In a crossover study, 45 male farmers from Chitwan, Nepal, were randomly allocated to work as usual applying organophosphate pesticides wearing Locally Adapted Personal Protective Equipment or Daily Practice Clothing. For seven days before each experiment, each farmer.......08; 0.06]. Wearing the Locally Adapted Personal Protective Equipment versus Daily Practice Clothing gave the following results, respectively: comfort 75.6% versus 100%, sense of heat 64.4% versus 31.3%, other problems 44.4% versus 33.3%, like-ability 95.6% versus 77.8%. Conclusion: We cannot support...

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

    Directory of Open Access Journals (Sweden)

    Eri Eguchi

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

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

    Science.gov (United States)

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

    2015-09-01

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

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

    Science.gov (United States)

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

    2016-01-01

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

  9. Korean Red Ginseng exhibits no significant adverse effect on disease activity in patients with rheumatoid arthritis: a randomized, double-blind, crossover study

    Directory of Open Access Journals (Sweden)

    Soo-Kyung Cho

    2018-04-01

    Full Text Available Background: Panax ginseng is a well-known immune modulator, and there is concern that its immune-enhancing effects may negatively affect patients with rheumatoid arthritis (RA by worsening symptoms or increasing the risk of adverse effects from other drugs. In this randomized, crossover clinical trial, we evaluated the impact of Korean Red Ginseng (KRG on disease activity and safety in RA patients. Methods: A total of 80 female RA patients were randomly assigned to either the KRG (2 g/d, n = 40 treatment or placebo (n = 40 groups for 8 wk, followed by crossover to the other treatment group for an additional 8 wk. The primary outcome was the disease flare rate, defined as worsening disease activity according to the disease activity score 28 joints-erythrocyte sedimentation rate (DAS28-ESR. The secondary outcomes were development of adverse events (AEs and patient reported outcomes. Outcomes were evaluated at baseline and 8 wk and 16 wk. The outcomes were compared using the Chi-square test. Results: Of the 80 patients, 70 completed the full study. Their mean age was 51.9 yr, and most exhibited low disease activity (mean DAS28-ESR 3.5 ± 1.0 at enrollment. After intervention, the flare rate was 3.7% in each group. During KRG treatment, 10 AEs were reported, while five AEs were developed with placebo; however, this difference was not statistically significant (p = 0.16. Gastrointestinal- and nervous system-related symptoms were frequent in the KRG group. Conclusion: KRG is not significantly associated with either disease flare rate or the rate of AE development in RA patients. Keywords: effect, Korean Red Ginseng, rheumatoid arthritis, safety

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

    Science.gov (United States)

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

    2016-12-01

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

  11. 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.

  12. Diosgenin-Rich Yam Extract Enhances Cognitive Function: A Placebo-Controlled, Randomized, Double-Blind, Crossover Study of Healthy Adults

    Directory of Open Access Journals (Sweden)

    Chihiro Tohda

    2017-10-01

    Full Text Available Diosgenin, a yam-derived compound, was found to facilitate the repair of axonal atrophy and synaptic degeneration and improve memory dysfunction in a transgenic mouse model of Alzheimer’s disease (AD. It was also found to enhance neuronal excitation and memory function even in normal mice. We hypothesized that diosgenin, either isolated or in an extract, may represent a new category of cognitive enhancers with essential activities that morphologically and functionally reinforce neuronal networks. This study aimed to investigate the effects of a diosgenin-rich yam extract on cognitive enhancement in healthy volunteers. For this placebo-controlled, randomized, double-blind, crossover study, 28 healthy volunteers (age: 20–81 years were recruited from Toyama Prefecture, Japan, and was randomly assigned to receive either a yam extract or placebo. Preliminary functional animal experiments indicated that an oil solvent mediated the most efficient distribution of diosgenin into the blood and brain after oral administration, and was a critical factor in the cognitive benefits. Therefore, test samples (placebo and yam extract were prepared with olive oil and formulated as soft capsules. The intake period was 12 weeks, and a 6-week washout period separated the two crossover intake periods. The Japanese version of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS test was used for neurocognitive assessment, and the adverse effects were monitored through blood testing. Diosgenin-rich yam extract consumption for 12 weeks yielded significant increases in total RBANS score. Among the 12 individual standard cognitive subtests, diosgenin-rich yam extract use significantly improved the semantic fluency. No adverse effects were reported. The diosgenin-rich yam extract treatment appeared to safely enhance cognitive function in healthy adults.

  13. Cognition and sensation in very high static magnetic fields: a randomized case-crossover study with different field strengths.

    Science.gov (United States)

    Heinrich, Angela; Szostek, Anne; Meyer, Patric; Nees, Frauke; Rauschenberg, Jaane; Gröbner, Jens; Gilles, Maria; Paslakis, Georgios; Deuschle, Michael; Semmler, Wolfhard; Flor, Herta

    2013-01-01

    To establish the extent to which representative cognitive functions in subjects undergoing magnetic resonance (MR) imaging are acutely impaired by static magnetic fields of varying field strengths. This study was approved by the local ethics committee, and informed consent was obtained from all subjects. In this single-blind case-crossover study, 41 healthy subjects underwent an extensive neuropsychologic examination while in MR units of differing field strengths (1.5, 3.0, and 7.0 T), including a mock imager with no magnetic field as a control condition. Subjects were blinded to field strength. Tests were performed while subjects were lying still in the MR unit and while the examination table was moved. The tests covered a representative set of cognitive functions, such as memory, eye-hand coordination, attention, reaction time, and visual discrimination. Subjective sensory perceptions were also assessed. Effects were analyzed with a repeated-measures analysis of variance; the within-subject factors were field strength (0, 1.5, 3.0, and 7.0 T) and state (static, dynamic). Static magnetic fields were not found to have a significant effect on cognitive function at any field strength. However, sensory perceptions did vary according to field strength. Dizziness, nystagmus, phosphenes, and head ringing were related to the strength of the static magnetic field. Static magnetic fields as high as 7.0 T did not have a significant effect on cognition. RSNA, 2012

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

    Science.gov (United States)

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

    2016-12-01

    Sleep deprivation and coffee caffeine consumption have been shown to affect glucose homeostasis separately, but the combined effects of these two variables are unknown. Forty-two healthy Iranian men, aged 20-40 years old, were assigned to three groups in a randomised crossover trial involving three treatments with two-week washout periods. Subjects were moderate coffee consumers (Sleep Quality Index sleep (4 hrs. in bed) plus 3×150 cc/cup of boiled water (BW treatment), decaffeinated coffee (DC treatment, without sugar, 99.9% caffeine-free), and caffeinated coffee (CC treatment, without sugar, 65 mg caffeine/ cup). DC and CC treatments were blinded. At the end of each treatment, fasting serum glucose (using enzyme assays) and insulin (using electrochemiluminescence immunoassay) were measured and, again, two hours after an oral glucose tolerance test (OGTT). Insulin resistance was quantified with the homeostasis model. Repeated measures ANOVA indicated no significant difference between the treatments in fasting serum glucose (p=0.248) or insulin resistance (p=0.079). However, ANOVA demonstrated differences between treatments in fasting serum insulin (p=0.004) and glucose, as well as insulin after OGTT (pcaffeinated coffee was more adverse for glucose homeostasis compared to decaffeinated coffee in individuals who were simultaneously sleep deprived.

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

    DEFF Research Database (Denmark)

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

    2014-01-01

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

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

    Science.gov (United States)

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

    2016-05-20

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

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

    Science.gov (United States)

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

    2018-02-01

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

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

    Science.gov (United States)

    Arora, Suman; Sayeed, Huma; Bhardwaj, Neerja

    2013-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Suman Arora

    2013-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Karen Windey

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

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

    Science.gov (United States)

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

    2017-10-01

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

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

    Science.gov (United States)

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

    2013-01-01

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

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

    Science.gov (United States)

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

    2015-08-01

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

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

    Science.gov (United States)

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

    2007-07-01

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

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

    Science.gov (United States)

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

    2017-06-21

    An increase in the frequency of cardiovascular diseases has been observed in the HIV/AIDS population. Studies involving healthy subjects or subjects with other diseases have shown benefits of chocolate supplementation on endothelial function and vasodilation. We evaluate the impact of chocolate consumption on arterial elasticity in people living with human immunodeficiency virus - PLHIV. A double-blind, crossover trial including 110 PLHIV (19 to 59 years) on antiretroviral therapy - ART for at least 6 months and with a viral load of <500 copies per mL was conducted. All subjects were randomly assigned to 15-d dietary supplements containing dark chocolate or placebo with a 15-d washout period. Each participant received one of the two sequences: A (dark chocolate, placebo chocolate); B (placebo chocolate, dark chocolate). Arterial elasticity was measured using the HDI/PulseWave™ CR-2000 CardioVascular Profiling System®. Body composition, lipid profile, C-reactive protein, and thiobarbituric acid reactive substances were also assessed. Analysis of variance (ANOVA) for repeated measures using the Stata 11.0® program was used for cross-over analysis. Most subjects were men (59.0%) and Caucasian (46.1%) and the mean age was 44.6 ± 7.1 years. The mean time since diagnosis of HIV infection was 13.7 ± 5.3 years and the mean duration of ART was 12.9 ± 4.2 years. Chocolate consumption resulted in significant alterations in the large artery elasticity index - LAEI (p = 0.049) and the mean concentration of HDL-c was higher after supplementation with dark chocolate (p = 0.045). This is the first study to evaluate the effect of chocolate on arterial elasticity in PLHIV. The results showed that dark chocolate consumption for 15 days improved the elastic properties of the LAEI in PLHIV. These findings, added to the noninvasive method used, may expand the knowledge of CVDs in this population.

  6. Hormone-Balancing Effect of Pre-Gelatinized Organic Maca (Lepidium peruvianum Chacon): (III) Clinical responses of early-postmenopausal women to Maca in double blind, randomized, Placebo-controlled, crossover configuration, outpatient study

    OpenAIRE

    Meissner, H. O.; Mscisz, A.; Reich-Bilinska, H.; Mrozikiewicz, P.; Bobkiewicz-Kozlowska, T.; Kedzia, B.; Lowicka, A.; Barchia, I.

    2006-01-01

    This is the second, conclusive part of the clinical study on clinical responses of early-postmenopausal women to standardized doses of pre-Gelatinized Organic Maca (Maca-GO). Total of 34 Caucasian women volunteers participated in a double-blind, randomized, four months outpatient crossover configuration Trial. After fulfilling the criteria of being early-postmenopausal: blood Estrogen (E230 IU/ml) at admission, they were randomly allocated to Placebo (P) and Maca-GO (M) treatments (2 groups o...

  7. 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.

  8. "Is powered toothbrush better than manual toothbrush in removing dental plaque?" - A crossover randomized double-blind study among differently abled, India.

    Science.gov (United States)

    Neelima, Mallam; Chandrashekar, Byalakere Rudraiah; Goel, Shubhi; Sushma, Rudraswamy; Srilatha, Yarramasu

    2017-01-01

    Although mechanical plaque removal is an effective method, powered toothbrushes are specially designed to benefit differently abled. Literature comparing plaque removal efficacy between manual and powered toothbrushes among differently abled is sparse. A cross-over, randomized, double-blind study was conducted in differently abled institution. Twenty differently abled participants were randomly assigned to two groups of ten participants. Plaque removal efficacy of battery-operated powered toothbrush was compared with manual toothbrush in a single brushing on the 8 th day. After a washout of 1 week, groups were switched. Assessment of plaque scores was done using Turesky's modification of Quigley-Hein plaque index. Difference in plaque score between pre- and post-brushing in each group was compared using paired sample t -test. In the pooled data analysis combining the results of Phase I and II, mean pre- and post-brushing plaque scores with manual toothbrush was 2.26 ± 0.4 and 1.93 ± 0.5, respectively, while with powered toothbrush, it was 2.21 ± 0.4 and 1.96 ± 0.4, respectively. However, difference in mean plaque reduction between manual and powered toothbrushes was not significant. Manual toothbrushes were equally effective compared to powered toothbrushes. Long-term studies precisely documenting cost-effectiveness and participant perception in the ease of use are recommended to validate our results.

  9. “Is powered toothbrush better than manual toothbrush in removing dental plaque?” – A crossover randomized double-blind study among differently abled, India

    Science.gov (United States)

    Neelima, Mallam; Chandrashekar, Byalakere Rudraiah; Goel, Shubhi; Sushma, Rudraswamy; Srilatha, Yarramasu

    2017-01-01

    Background: Although mechanical plaque removal is an effective method, powered toothbrushes are specially designed to benefit differently abled. Literature comparing plaque removal efficacy between manual and powered toothbrushes among differently abled is sparse. Study Design and Setting: A cross-over, randomized, double-blind study was conducted in differently abled institution. Materials and Methods: Twenty differently abled participants were randomly assigned to two groups of ten participants. Plaque removal efficacy of battery-operated powered toothbrush was compared with manual toothbrush in a single brushing on the 8th day. After a washout of 1 week, groups were switched. Assessment of plaque scores was done using Turesky's modification of Quigley-Hein plaque index. Statistical Analysis: Difference in plaque score between pre- and post-brushing in each group was compared using paired sample t-test. Results: In the pooled data analysis combining the results of Phase I and II, mean pre- and post-brushing plaque scores with manual toothbrush was 2.26 ± 0.4 and 1.93 ± 0.5, respectively, while with powered toothbrush, it was 2.21 ± 0.4 and 1.96 ± 0.4, respectively. However, difference in mean plaque reduction between manual and powered toothbrushes was not significant. Conclusion: Manual toothbrushes were equally effective compared to powered toothbrushes. Long-term studies precisely documenting cost-effectiveness and participant perception in the ease of use are recommended to validate our results. PMID:29398859

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Vuotila Tuija

    2007-12-01

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

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

    Science.gov (United States)

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

    2014-11-01

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

  13. Efficacy and tolerance of a diabetes specific formula in patients with type 2 diabetes mellitus: An open label, randomized, crossover study.

    Science.gov (United States)

    Gulati, Seema; Misra, Anoop; Nanda, Kriti; Pandey, Ravindra M; Garg, Vivek; Ganguly, Sanjeev; Cheung, Lorena

    2015-01-01

    This study evaluated the effect of a diabetes specific formula on acute glucose, insulin, and triglyceride responses in patients with type 2 diabetes mellitus (T2DM). This open-label, randomized, crossover, pilot single center study had two phases (pre-treatment and treatment). After screening, the patients entered run-in period and were counseled on diet and exercise regime. They were then randomly allocated to receive either diabetes specific formula (Nutren Diabetes, Nestlé Health Science, Switzerland; Group A) or isocaloric meal (Cornflakes and milk; Group B). Blood samples were collected to estimate blood glucose, insulin and triglyceride levels (Baseline at 0 min and post-meal at 30, 60, 120, and 180 min). Area under curve for blood glucose post-meal at 30 min, 60 min, 120 min, and 180 min was significantly lower for Group A as compared with Group B (p=0.003, 0.0001, 0.0001, 0.0001, respectively). Increase in serum insulin levels from baseline was also lower for Group A post-meal at 120 and 180 min, respectively, as compared to Group B (p=0.0001 and 0.0002, respectively). The Diabetes specific formula tested in this study showed lower post-meal blood glucose and insulin levels as compared with isocaloric meal. Thus, diabetes specific formula may be an option for diabetic and hyperglycemic patients in need of nutritional support. Copyright © 2014 Diabetes India. Published by Elsevier Ltd. All rights reserved.

  14. Influence of neural mobilization of lower limbs on the functional performance and dynamic balance in asymptomatic individuals: a cross-over randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Nunes Guilherme S.

    2017-12-01

    Full Text Available Purpose. To verify the influence of neural mobilization (NM applied to the lower limbs on functional performance and dynamic balance in asymptomatic individuals. Methods. The total of 30 asymptomatic participants (15 women and 15 men; age, 30.1 ± 6.7 years; height, 1.70 ± 0.1 m; body mass, 73.1 ± 13.4 kg were enrolled in this cross-over randomized controlled trial. The participants received NM of the femoral, sciatic, and tibial nerves, as well as static stretching (SS of the following muscles: hamstring, lumbar, piriformis, hip adductors, hip flexors, quadriceps, and triceps surae. The order of applying NM and SS was randomly decided and the interventions were performed at least 48 hours apart. Functional performance was measured by performance in vertical jump (VJ and dynamic balance was measured with the Star Excursion Balance Test (SEBT. Results. There were no differences between NM and SS for height (cm in VJ (p = 0.16 or in the distance reached (% in the SEBT, normalized by lower limb length (dominant limb: anterior, p = 0.35; posterolateral, p = 0.69; posteromedial, p = 0.50 / non-dominant limb: anterior, p = 0.68; posterolateral, p = 1.00; posteromedial, p = 0.77. Conclusions. NM did not exert any influence on functional performance or dynamic balance. Thereby, having no positive or negative impact on performance, NM can be used at any time of treatment.

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

    Science.gov (United States)

    Tawasri, Patcharanee; Ampasavate, Chadarat; Tharatha, Somsak

    2016-01-01

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

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

    Science.gov (United States)

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

    2015-12-01

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

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

    Science.gov (United States)

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

    2018-03-01

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

  18. Korean traditional Chungkookjang improves body composition, lipid profiles and atherogenic indices in overweight/obese subjects: a double-blind, randomized, crossover, placebo-controlled clinical trial.

    Science.gov (United States)

    Byun, M-S; Yu, O-K; Cha, Y-S; Park, T-S

    2016-10-01

    Chungkookjang is a Korean representative fermented soybean food. In this study, we investigated the effect of Korean traditional Chungkookjang compared with placebo on body composition, dyslipidemia and risk factors for atherosclerosis in overweight/obese subjects. This double-blind, randomized, controlled crossover trial was conducted on 120 overweight/obese subjects, aged 19-29 years. Subjects were randomly divided into a Chungkookjang (n=60) or a placebo (n=60) group. After 12 weeks, the groups were crossed over for an additional 12 weeks. During the intervention period, subjects were asked to maintain their usual diet and activity and not to take any functional foods or dietary supplements. The anthropometric measures, lipid profiles and atherogenic indices were determined at baseline and at the end of each 12-week period. The anthropometry measurements, percentage body fat, lean body mass, waist circumference and waist-to-hip ratio of women in the Chungkookjang group were significantly improved compared with the placebo group. Lipid profiles and high-sensitivity C-reactive protein of women in Chungkookjang were significantly improved. The atherogenic indices of apolipoprotein B/apolipoprotein A1 decreased in both the placebo and the Chungkookjang group, and it also decreased below 0.55 for all the men and women in the Chungkookjang group. In conclusion, these results suggest that supplementation with Chungkookjang may improve body composition and risk factors for cardiovascular disease in overweight and obese adults.

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

    Science.gov (United States)

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

    2018-02-08

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

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

    Science.gov (United States)

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

    2013-08-01

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

  1. The effect of music on biochemical markers and self-perceived stress among first-line nurses: a randomized controlled crossover trial.

    Science.gov (United States)

    Lai, Hui-Ling; Li, Yin-Ming

    2011-11-01

    The aim of this study was to examine the effects of music on stress indices and to examine the association between music preference and stress. Although clinical studies have demonstrated the effectiveness of music on stress, study results have been inconsistent. At the time of writing, no known publications had investigated the effects of preferred music on workers in high-stress professions such as nursing. Using a randomized crossover controlled trial, 54 nurses were randomly assigned to a music/chair rest sequence or chair rest/music sequence during the period February to June 2006. Each intervention lasted for 30 minutes. Participants in the music condition listened to self-selected soothing music using headphones for 30 minutes. In the chair rest condition, participants sat quietly for 30 minutes. Serial measurements of participants' heart rate, mean arterial pressure, finger temperature and cortisol levels were taken with a BP monitor and chemillumincent immunoassay every 15 minutes throughout the procedure. Compared with chair rest, participants had a lower perceived stress level, cortisol, heart rate, mean arterial pressure and higher finger temperature while listening to music (P Music preference scores ranged between 7 and 10, with a mean score of 8·81 (sd = 1·05), and was significantly associated with mean arterial pressure, cortisol levels, self-perceived stress and finger temperature. The findings provided evidence for nurses to use soothing music as a research-based nursing intervention for stress reduction. © 2011 The Authors. Journal of Advanced Nursing © 2011 Blackwell Publishing Ltd.

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

    Science.gov (United States)

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

    2014-12-01

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

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

    Science.gov (United States)

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

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

    DEFF Research Database (Denmark)

    Hansen, Ditte; Rasmussen, Knud; Danielsen, Henning

    2011-01-01

    Alfacalcidol and paricalcitol are vitamin D analogs used for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease, but have known dose-dependent side effects that cause hypercalcemia and hyperphosphatemia. In this investigator-initiated multicenter randomized...... were equally effective in the suppression of secondary hyperparathyroidism in hemodialysis patients while calcium and phosphorus were kept in the desired range...

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

    Science.gov (United States)

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

    2016-02-01

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

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

    Science.gov (United States)

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

    2017-12-01

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

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

    Science.gov (United States)

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

    2012-02-01

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

  8. Randomized crossover comparison of right atrial appendage pacing versus interatrial septum pacing for prevention of paroxysmal atrial fibrillation in patients with sinus bradycardia.

    Science.gov (United States)

    Padeletti, L; Pieragnoli, P; Ciapetti, C; Colella, A; Musilli, N; Porciani, M C; Ricci, R; Pignalberi, C; Santini, M; Puglisi, A; Azzolini, P; Spampinato, A; Martelli, M; Capucci, A; Boriani, G; Botto, G; Proclemer, A

    2001-12-01

    New atrial pacing techniques and overdrive pacing algorithms have been introduced to prevent atrial fibrillation. This study was designed to test the hypotheses that (1) interatrial septum pacing (IASP) at the triangle of Koch would be more effective than right atrial appendage pacing (RAAP) in preventing paroxysmal atrial fibrillation (PAF) in patients with sinus bradycardia and (2) an algorithm (CAP) designed to achieve constant atrial capture would increase the efficacy of rate-responsive atrial pacing. We studied 46 patients with PAF and sinus bradycardia implanted with a DDD(R) (Medtronic Thera) pacemaker. Twenty-four patients (6.0 +/- 10.1 PAF episodes/month within 3 months before study) were randomized to RAAP and 22 patients (5.4 +/- 7.1, not significant) to IASP. Within each arm 2 randomized crossover periods of CAP-OFF and CAP-ON function were programed. The PAF episodes per month significantly decreased in the RAAP (CAP-OFF: 2.1 +/- 4.2, P <.05; CAP-ON: 1.9 +/- 3.8, P <.05) and in the IASP group (CAP-OFF: 0.2 +/- 0.5, P <.05; CAP-ON: 0.2 +/- 0.5, P <.05). Values were significantly lower in the IASP group than in the RAAP group in both CAP-OFF (0.2 +/- 0.5 vs 2.1 +/- 4.2, P <.05) and CAP-ON (0.2 +/- 0.5 vs 1.9 +/- 3.8, P <.05) conditions. PAF burden was significantly lower in the IASP than in the RAAP group in CAP-OFF (47 +/- 84 min/d vs 140 +/- 217, P <.05) and in CAP-ON (41 +/- 72 vs 193 +/- 266, P <.05) conditions. No differences were observed within each arm in PAF burden between the 2 crossover CAP programing periods. Rate-adaptive IASP at the triangle of Koch is more effective than RAAP in preventing PAF in patients with sinus bradycardia. In our sample of patients no additional clinical benefit is furnished by the CAP algorithm.

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

    Science.gov (United States)

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

    2014-01-07

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

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

    Science.gov (United States)

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

    2017-06-06

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

  11. Supplementation with a Polyphenol-Rich Extract, PerfLoad®, Improves Physical Performance during High-Intensity Exercise: A Randomized, Double Blind, Crossover Trial

    Directory of Open Access Journals (Sweden)

    Julien Cases

    2017-04-01

    Full Text Available Workout capacity is energy-production driven. To produce peak metabolic power outputs, the organism predominantly relies more on anaerobic metabolism, but this undoubtedly has a negative and limiting impact on muscle function and performance. The aim of the study was to evaluate if an innovative polyphenol-based food supplement, PerfLoad®, was able to improve metabolic homeostasis and physical performance during high-intensity exercises under anaerobic conditions. The effect of a supplementation has been investigated on fifteen recreationally-active male athletes during a randomized, double-blind and crossover clinical investigation. The Wingate test, an inducer of an unbalanced metabolism associated to oxidative stress, was used to assess maximum anaerobic power during a high-intensity exercise on a cycle ergometer. Supplementation with PerfLoad® correlated with a significant increase in total power output (5%, maximal peak power output (3.7%, and average power developed (5%, without inducing more fatigue or greater heart rate. Instead, oxidative homeostasis was stabilized in supplemented subjects. Such results demonstrated that PerfLoad® is a natural and efficient solution capable of, similarly to training benefits, helping athletes to improve their physical performance, while balancing their metabolism and reducing exercise-induced oxidative stress.

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

    Science.gov (United States)

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

    2014-01-01

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

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

    Science.gov (United States)

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

    2017-10-25

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

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

    Science.gov (United States)

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

    2018-01-01

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

  15. Cranberry (poly)phenol metabolites correlate with improvements in vascular function: A double-blind, randomized, controlled, dose-response, crossover study.

    Science.gov (United States)

    Rodriguez-Mateos, Ana; Feliciano, Rodrigo P; Boeres, Albert; Weber, Timon; Dos Santos, Claudia Nunes; Ventura, M Rita; Heiss, Christian

    2016-10-01

    Cranberries are rich in potentially bioactive (poly)phenols. The aim of this paper was to investigate whether cranberry juice intake can improve vascular function in healthy men in a dose- and time-dependent manner, and to understand which of the circulating (poly)phenol metabolites correlate with vascular effects. A double-blind randomized controlled crossover trial was conducted in ten healthy males. Flow-mediated dilation (FMD), blood pressure, pulse wave velocity and augmentation index were investigated at baseline, 1, 2, 4, 6, and 8 h post-consumption of cranberry juices containing 409, 787, 1238, 1534, and 1910 mg of total cranberry (poly)phenols (TP), and a control drink. Plasma (poly)phenol metabolites were analyzed by UPLC-Q-TOF MS using authentic standards. We observed dose-dependent increases in FMD at 1, 2, 4, 6, and 8 h with a peak at 4 h and maximal effects with juice containing 1238 mg TP. A total of 60 metabolites were quantified in plasma after cranberry consumption. Twelve (poly)phenol metabolites significantly correlated with the increases in FMD, including ferulic and caffeic acid sulfates, quercetin-3-O-ß-D-glucuronide and a γ-valerolactone sulfate. (Poly)phenols in cranberry juice can improve vascular function in healthy males and this is linked to the presence of specific newly identified plasma metabolites. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

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

    Science.gov (United States)

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

    2018-01-01

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

  17. Postprandial lipid responses to an alpha-linolenic acid-rich oil, olive oil and butter in women: a randomized crossover trial.

    Science.gov (United States)

    Svensson, Julia; Rosenquist, Anna; Ohlsson, Lena

    2011-06-28

    Postprandial lipaemia varies with gender and the composition of dietary fat due to the partitioning of fatty acids between beta-oxidation and incorporation into triacylglycerols (TAGs). Increasing evidence highlights the importance of postprandial measurements to evaluate atherogenic risk. Postprandial effects of alpha-linolenic acid (ALA) in women are poorly characterized. We therefore studied the postprandial lipid response of women to an ALA-rich oil in comparison with olive oil and butter, and characterized the fatty acid composition of total lipids, TAGs, and non-esterified fatty acids (NEFAs) in plasma. A randomized crossover design (n = 19) was used to compare the postprandial effects of 3 meals containing 35 g fat. Blood samples were collected at regular intervals for 7 h. Statistical analysis was carried out with ANOVA (significant difference = P postprandial p-TAG and NEFA response in healthy pre-menopausal women was not significantly different after the intake of an ALA-rich oil, olive oil and butter. The ALA-rich oil significantly affected different plasma lipid fractions and improved the ratio of n-6 to n-3 fatty acids several hours postprandially.

  18. 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.

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

    Science.gov (United States)

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

    2015-11-01

    To investigate effects of omega-3 polyunsaturated fatty acids (n-3 PUFA) docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) on attention, literacy, and behavior in children with ADHD. Ninety children were randomized to consume supplements high in EPA, DHA, or linoleic acid (control) for 4 months each in a crossover design. Erythrocyte fatty acids, attention, cognition, literacy, and Conners' Parent Rating Scales (CPRS) were measured at 0, 4, 8, 12 months. Fifty-three children completed the treatment. Outcome measures showed no significant differences between the three treatments. However, in children with blood samples (n = 76-46), increased erythrocyte EPA + DHA was associated with improved spelling (r = .365, p < .001) and attention (r = -.540, p < .001) and reduced oppositional behavior (r = -.301, p < .003), hyperactivity (r = -.310, p < .001), cognitive problems (r = -.326, p < .001), Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV) hyperactivity (r = -.270, p = .002) and DSM-IV inattention (r = -.343, p < .001). Increasing erythrocyte DHA and EPA via dietary supplementation may improve behavior, attention, and literacy in children with ADHD. © The Author(s) 2013.

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

    Directory of Open Access Journals (Sweden)

    Karen J. Murphy

    2014-02-01

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

  1. Dietary milk fat globule membrane supplementation combined with regular exercise improves skeletal muscle strength in healthy adults: a randomized double-blind, placebo-controlled, crossover trial.

    Science.gov (United States)

    Soga, Satoko; Ota, Noriyasu; Shimotoyodome, Akira

    2015-08-25

    Our previous studies demonstrated that dietary supplementation with milk fat globule membrane (MFGM) combined with habitual exercise improved muscle strength by stimulating neuromuscular development in mice. This study aimed to demonstrate the beneficial effects of dietary MFGM supplementation plus regular exercise on muscle strength and neuromuscular function in healthy humans. The study was designed as a randomized, double-blind, placebo-controlled, crossover trial. Fourteen Japanese adults aged 31-48 years took daily MFGM (1 g) or placebo tablets during the 4-week study period and attended a training program twice a week. Physical function tests and surface electromyography (EMG) were conducted at baseline and at the end of the study period. The MFGM group had significantly greater leg extension strength than the placebo group after the 4-week study period. Surface EMG showed that the MFGM group had a significantly higher root mean square amplitude than the placebo group, which indicated that the MFGM group had higher motor unit activity. Dietary MFGM supplementation combined with regular exercise improves skeletal muscle strength, which may be due to increased motor unit recruitment in healthy Japanese middle-aged adults.

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

    Science.gov (United States)

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

    1990-01-01

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

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

    Science.gov (United States)

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

    2015-10-01

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

  4. The Short-Term Effects of Transcranial Direct Current Stimulation on Electroencephalography in Children with Autism: A Randomized Crossover Controlled Trial

    Directory of Open Access Journals (Sweden)

    Anuwat Amatachaya

    2015-01-01

    Full Text Available Abnormal synaptic maturation and connectivity are possible etiologies of autism. Previous studies showed significantly less alpha activity in autism than normal children. Therefore, we studied the effects of anodal tDCS on peak alpha frequency (PAF related to autism treatment evaluation checklist (ATEC. Twenty male children with autism were randomly assigned in a crossover design to receive a single session of both active and sham tDCS stimulation (11 mA over F3 (left dorsolateral prefrontal cortex. Pre- to postsession changes in a measure of cortical activity impacted by tDCS (PAF and ATEC were compared between groups. We also examined the associations between pre- and postsession changes in the PAF and ATEC. The results show significant pre- to postsession improvements in two domains of ATEC (social and health/behavior domains following active tDCS, relative to sham treatment. PAF also significantly increased at the stimulation site, and an increase in PAF was significantly associated with improvements in the two domains of ATEC impacted by tDCS. The findings suggest that a single session of anodal tDCS over the F3 may have clinical benefits in children with autism and that those benefits may be related to an increase in PAF.

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

    Science.gov (United States)

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

    2017-08-01

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

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

    Science.gov (United States)

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

    2011-06-01

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

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

    Science.gov (United States)

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

    2013-09-01

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

  8. Effect of a mouthrinse containing rice peptide CL(14-25) on early dental plaque regrowth: a randomized crossover pilot study.

    Science.gov (United States)

    Takayama, Saori; Kato, Tetsuo; Imamura, Kentaro; Kita, Daichi; Ota, Koki; Suzuki, Eiichi; Sugito, Hiroki; Saitoh, Eiichi; Taniguchi, Masayuki; Saito, Atsushi

    2015-10-03

    We aimed to evaluate clinically the effect of mouthrinse containing a rice peptide on early dental plaque regrowth. The study was designed as a double-masked, two-group crossover randomized pilot trial, involving 10 periodontally healthy volunteers. After receiving a professional tooth cleaning at baseline, over the next 3 days each participant refrained from all oral hygiene measures and had two daily rinses with 20 ml of the test mouthrinse containing 0.4 % rice peptide CL(14-25) or placebo rinse. At the end of each experimental period, plaque score was assessed using the modified Volpe's method, and the participants filled out a questionnaire. Each participant underwent a 7-day washout period followed by a second allocation. The plaque score was the primary outcome of the study and participant perception was the secondary outcome. No adverse effects were observed in the participants during the study. Clinically, the mean plaque score of the examined teeth was significantly lower in the test group (2.44 ± 0.74, CI: 1.91-2.96) than the placebo group (2.65 ± 0.63, CI: 2.20-3.10) (P plaque. However, clinical relevance of this efficacy needs to be validated in a future large-scale study. UMIN Clinical Trials Registry (UMIN-CTR) R000014000. Date of formal registration: November 1, 2013.

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

    Directory of Open Access Journals (Sweden)

    Eunice Kazue Kano

    2015-03-01

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

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

    Directory of Open Access Journals (Sweden)

    Ilse C Schrieks

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

  11. 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 (Pbeetroot 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.

  12. Acute Effects of Nitrate-Rich Beetroot Juice on Blood Pressure, Hemostasis and Vascular Inflammation Markers in Healthy Older Adults: A Randomized, Placebo-Controlled Crossover Study

    Science.gov (United States)

    Raubenheimer, Kyle; Hickey, Danica; Leveritt, Michael; Fassett, Robert; Ortiz de Zevallos Munoz, Joaquin; Briskey, David; Kerr, Graham; Peake, Jonathan M.; Pecheniuk, Natalie M.

    2017-01-01

    Aging is associated with a vasoconstrictive, pro-coagulant, and pro-inflammatory profile of arteries and a decline in the bioavailability of the endothelium-derived molecule nitric oxide. Dietary nitrate elicits vasodilatory, anti-coagulant and anti-inflammatory effects in younger individuals, but little is known about whether these benefits are evident in older adults. We investigated the effects of 140 mL of nitrate-rich (HI-NI; containing 12.9 mmol nitrate) versus nitrate-depleted beetroot juice (LO-NI; containing ≤0.04 mmol nitrate) on blood pressure, blood coagulation, vascular inflammation markers, plasma nitrate and nitrite before, and 3 h and 6 h after ingestion in healthy older adults (five males, seven females, mean age: 64 years, age range: 57–71 years) in a randomized, placebo-controlled, crossover study. Plasma nitrate and nitrite increased 3 and 6 h after HI-NI ingestion (p beetroot juice intake (p beetroot juice ingestion (p effects of nitrate-rich beetroot juice on circulating immune cells and platelets. Further long-term research is warranted to determine if these effects reduce the risk of developing hypertension and vascular inflammation with aging. PMID:29165355

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

    Science.gov (United States)

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

    2016-07-01

    Little is known about treating low self-esteem in anxiety disorders. This study evaluated two treatments targeting different mechanisms: (1) Eye Movement Desensitization and Reprocessing (EMDR), which aims to desensitize negative memory representations that are proposed to maintain low self-esteem; and (2) Competitive Memory Training (COMET), which aims to activate positive representations for enhancing self-esteem. A Randomized Controlled Trial (RCT) was used with a crossover design. Group 1 received six sessions EMDR first and then six sessions COMET; group 2 vice versa. Assessments were made at baseline (T0), end of first treatment (T1), and end of second treatment (T2). Main outcome was self-esteem. We included 47 patients and performed Linear Mixed Models. COMET showed more improvements in self-esteem than EMDR: effect-sizes 1.25 versus 0.46 post-treatment. Unexpectedly, when EMDR was given first, subsequent effects of COMET were significantly reduced in comparison to COMET as the first intervention. For EMDR, sequence made no difference. Reductions in anxiety and depression were mediated by better self-esteem. COMET was associated with significantly greater improvements in self-esteem than EMDR in patients with anxiety disorders. EMDR treatment reduced the effectiveness of subsequent COMET. Improved self-esteem mediated reductions in anxiety and depression symptoms. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Galpin Andrew J

    2009-08-01

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

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

    Science.gov (United States)

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

    1987-12-01

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

  16. Growth hormone enhances fat-free mass and glutamine availability in patients with short-bowel syndrome: an ancillary double-blind, randomized crossover study.

    Science.gov (United States)

    Seguy, David; Darmaun, Dominique; Duhamel, Alain; Thuillier, François; Cynober, Luc; Cortot, Antoine; Gottrand, Frédéric; Messing, Bernard

    2014-09-01

    Benefits of recombinant human growth hormone (rhGH) alone or combined with glutamine in patients with intestinal failure because of short-bowel syndrome remain controversial. We explored effects of rhGH on whole-body protein metabolism in patients with short-bowel syndrome with intestinal failure (SBS-IF) to gain insight into its mechanism of action. Eight stable hyperphagic patients with severe SBS-IF received, in a double-blind, randomized crossover study, low-dose rhGH (0.05 mg · kg⁻¹ · d⁻¹) and a placebo for two 3-wk periods. Leucine and glutamine kinetics under fasting and fed conditions, fat-free mass (FFM), and serum insulin were determined on the final day of each treatment. rhGH increased FFM and nonoxidative leucine disposal (NOLD; an index of protein synthesis) (P de novo synthesis (P de novo synthesis and intestinal absorption increase glutamine availability over the physiologic range, suggesting that beneficial effects of rhGH in hyperphagic patients might be achieved without glutamine supplementation. © 2014 American Society for Nutrition.

  17. [Use of the size 3 ProSeal laryngeal mask airway in children. Results of a randomized crossover investigation with the Classic laryngeal mask airway].

    Science.gov (United States)

    Goldmann, K; Roettger, C; Wulf, H

    2006-02-01

    The low-pressure airway seal of the Classic laryngeal mask airway (CLMA) can be inadequate for positive pressure ventilation (PPV) in children. The ProSeal laryngeal mask airway (PLMA) forms a more effective seal of the airway than the CLMA and facilitates gastric tube placement in adults. The size 3 PLMA can be used in adults and children. The CLMA and PLMA were studied in random order -- crossover -- in 30 anaesthetized, non-paralysed children (average age 10.6 years, average body weight 39 kg). Airway leak pressure, maximum tidal volume, ease of insertion, quality of initial airway and fiberoptic position were determined. Gastric tube placement was assessed for the PLMA. The mean airway leak pressure in neutral head position (27.0 vs. 16.8 cm H(2)O), maximum flexion (38.3 vs. 26.2 cm H(2)O) and maximum extension (21.1 vs. 14.2 cm H(2)O) as well as the mean maximum tidal volume (1432 vs. 1062 ml) were significantly higher (pairway leak pressure seem to make the size 3 PLMA a more suitable device for PPV in children than the same size CLMA.

  18. Child endotracheal intubation with a Clarus Levitan fiberoptic stylet vs Macintosh laryngoscope during resuscitation performed by paramedics: a randomized crossover manikin trial.

    Science.gov (United States)

    Szarpak, Lukasz; Truszewski, Zenon; Czyzewski, Lukasz; Kurowski, Andrzej; Bogdanski, Lukasz; Zasko, Piotr

    2015-11-01

    The main cause of cardiac arrest in pediatric patients is respiratory failure. To test the ability of paramedics to intubate the trachea of a child by means of the standard Macintosh [MAC] laryngoscope vs the Clarus Leviatan fiberoptic stylet (FPS) during 3-airway scenarios. This was a randomized crossover manikin study involving 89 paramedics. The participants performed tracheal intubations using the MAC laryngoscope and the Clarus Leviatan FPS in 3 pediatric airway scenarios: scenario A, normal airway without chest compression (CC); scenario B, normal airway with CC; and scenario C, difficult airway with CC. A total of 89 paramedics participated in this study. In scenario A, the FPS maintained a better success rate at first attempt (97.8% vs 88.9%; P=.73) and time required to intubate (17 [interquartile range, 15-21) seconds vs 18 [interquartile range, 16-22] seconds; P=.67) when compared with MAC. In scenarios B and C, the results with FPS were significantly better than those with MAC (P<.05) for all analyzed variables. This study suggested that the FPS could be used as an option for airway management even for paramedics with little experience. Future studies should explore the efficacy of FPS in pediatric clinical emergency settings. Copyright © 2015 Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2014-02-14

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

  20. Comparative Fasting Bioavailability of 2 Different Betahistine Dihydrochloride 24-mg Tablets: A Single- Dose, Randomized-Sequence, Open-Label, 2-Period Crossover Study in Healthy Thai Volunteers

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    Pinpilai Jutasompakorn

    2016-05-01

    Full Text Available Objective: To evaluate the bioequivalence of 24 mg betahistine dihydrochloride tablets between the test product (Stei® and the reference product (Serc® in healthy Thai volunteers. Methods: This was an open-label, randomized sequence, single-dose, two-period crossover study in 24 healthy volunteers. Half of the volunteers received a single dose of test product 24 mg and then reference product 24 mg after a minimum 7-day washout period. The remaining half of volunteers received the reference product first and then the test product with the same washout period. Blood samples were obtained at pre-dose and over 14 hours after dosing. Plasma concentrations of 2-pyridylacetic acid (2-PAA, a major metabolite of betahistine were quantified by using liquid chromatography with tandem mass spectrometry (LC-MS/MS. Tolerability in volunteers were assessed during the study. Results: Statistical comparison of the main pharmacokinetic parameters showed no significant difference between test and reference. The geometric mean ratios of 2-PAA between the test and reference products were 96.44%, 96.99%, and 94.56% for Cmax, AUC0-t, and AUC0-∞, respectively. These pharmacokinetic parameter values lie within the FDA and European Medicines Agency specified bioequivalence limit (80-125%. No serious adverse events related to the studied drugs were found. Conclusion: It can be concluded that these two betahistine dihydrochloride products were considered bioequivalent.

  1. Development, feasibility, and efficacy of a customized exercise device to deliver intradialytic resistance training in patients with end stage renal disease: Non-randomized controlled crossover trial.

    Science.gov (United States)

    Chan, Danwin; Green, Simon; Fiatarone Singh, Maria; Barnard, Robert; Cheema, Birinder S

    2016-10-01

    Introduction This study assessed the feasibility and efficacy of a novel resistance training device used within an intradialytic progressive resistance training (PRT) intervention. Methods Non-randomized, within-subjects crossover design with outcomes assessed at baseline (week 0), postcontrol (week 13) and post-PRT intervention (week 26). Twenty-two hemodialysis patients (59% men, 71 ± 11 years) performed PRT three sessions per week for 12 weeks. The resistance training device was developed to enable the performance of 2 upper body and 3 lower body exercises, unilaterally and bilaterally, both before and during dialysis, with loads of 2.5 to 59 kg. Feasibility outcomes included adverse events, adherence and training load progression. Changes in upper and lower body muscular strength, six-minute walk, aspects of health-related quality of life (HRQoL) and depression were evaluated. Findings The PRT intervention was delivered without serious adverse events, resulted in 71.2% ± 23.3% adherence and significant adaptation of all training loads from pre to mid to post training (83.8%-185.6%, all P Emotional) significantly increased (all P outcomes. Discussion PRT using the novel resistance training device was feasible and improved measures of physical and psychological health. This device can be utilized in most dialysis centers. Future studies are required to evaluate dose-response effects of PRT prescriptions in subpopulations, and the translation of PRT to standard dialysis practice. © 2016 International Society for Hemodialysis.

  2. Two-Way Radio in Schools (or, The Loneliness of the Long Distance Learner). An Evaluation of a High Frequency Short Wave, Two-Way Radio Trial.

    Science.gov (United States)

    Conboy, Ian

    The Country Education Project in Victoria, Australia, tested the use of two-way radios to bring educational resources to isolated children studying correspondence courses in small rural high schools and to increase interaction among rural schools. Eight rural Victoria schools and the Secondary Correspondence School in Melbourne used two-way…

  3. 77 FR 58579 - Certain Two-Way Global Satellite Communication Devices, System and Components Thereof...

    Science.gov (United States)

    2012-09-21

    ... Communication Devices, System and Components Thereof; Institution of Investigation Pursuant to 19 U.S.C. 1337... certain two-way global satellite communication devices, system and components thereof that infringe one or... within the United States after importation of certain two-way global satellite communication devices...

  4. 78 FR 31576 - Enforcement Proceeding; Certain Two-Way Global Satellite Communication Devices, System and...

    Science.gov (United States)

    2013-05-24

    ...-Way Global Satellite Communication Devices, System and Components Thereof; Notice of Institution of... importation of certain two-way global satellite communication devices, system and components thereof by reason... importation any two-way global satellite communication devices, system, and components thereof that infringe...

  5. Becoming More Than a Digital Bullhorn: Two Way Engagement on Twitter for Law Enforcement

    Science.gov (United States)

    2016-03-01

    reducing crime, and, in so doing, referenced two- way engagement on social media . One... media usage during crises, and discussion of one- way versus two- way social media communication. These topics often overlap, and are interwoven with...proactive style is the “most complicated” way to use social media , requiring time and resources to execute effectively .195 Lindsay, in a report for

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

    Science.gov (United States)

    Soleimani, Robabeh; Kousha, Maryam; Zarrabi, Homa; Tavafzadeh-Haghi, Seyede Mahnaz; Jalali, Mir Mohammad

    2017-07-01

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

  7. A Randomized, Double Blind, Placebo Controlled, Crossover Study to Assess the Safety and Beneficial Effects of Cassia Tora Supplementation in Healthy Adults.

    Science.gov (United States)

    Kambalachenu, Himavanth Reddy; Reddy, Thandlam Muneeswara; Rao, Sirpurkar Dattatreya; Dorababu, Kambalachenu; Reddy, Kanala Kodanda; Sarma, K V S

    2018-01-31

    The current clinical trial was aimed at evaluating the safety and beneficial effect of Cassia tora (C. tora) supplementation in healthy adults. A randomized, double blind, placebo controlled study with a crossover design was done on 60 healthy normal weight adults (age range: 20-55 yrs). The study consisted of 2 treatment phases of 24 weeks each with a washout period of 4 weeks between the phases. 30 subjects randomly allocated to the 'Placebo first' group and 30 to 'C. tora first' group and assigned to receive a dose of C. tora (330 mg) or matched placebo three times a day. Safety markers were measured at base line and at the end of both the treatment phases. Body mass index, blood pressure, fasting blood sugar, glycated hemoglobin, lipid profile and antioxidants were measured at baseline and at every three months interval. Repeated measures analysis was applied to assess the period and carryover effects of the drug over placebo on biochemistries. C. tora supplementation was well tolerated and no apparent changes were observed in safety markers. The net effect of C. tora in natural units over placebo was 0.83 [0.57, 1.09]- high density lipoprotein cholesterol; 27.63 [24.39, 30.88]- superoxide dismutase; 0.32 [0.28, 0.36]- catalase; 0.68 [0.56, 0.80]- glutathione peroxidase; 0.25 [0.22, 0.29]- glutathione s-transferase; 0.32 [0.29, 0.36]- glutathione and -1.08 [-1.63, -0.54]- low density lipoprotein cholesterol. The findings advocate that C. tora supplementation is safe and beneficial in elevating high density lipoprotein cholesterol and antioxidants and hence advised for consumption. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

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

    Science.gov (United States)

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

    2015-12-15

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

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

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    Asma Salari Moghaddam

    2014-01-01

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

  10. 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.

  11. Bystander fatigue and CPR quality by older bystanders: a randomized crossover trial comparing continuous chest compressions and 30:2 compressions to ventilations.

    Science.gov (United States)

    Liu, Shawn; Vaillancourt, Christian; Kasaboski, Ann; Taljaard, Monica

    2016-11-01

    This study sought to measure bystander fatigue and cardiopulmonary resuscitation (CPR) quality after five minutes of CPR using the continuous chest compression (CCC) versus the 30:2 chest compression to ventilation method in older lay persons, a population most likely to perform CPR on cardiac arrest victims. This randomized crossover trial took place at three tertiary care hospitals and a seniors' center. Participants were aged ≥55 years without significant physical limitations (frailty score ≤3/7). They completed two 5-minute CPR sessions (using 30:2 and CCC) on manikins; sessions were separated by a rest period. We used concealed block randomization to determine CPR method order. Metronome feedback maintained a compression rate of 100/minute. We measured heart rate (HR), mean arterial pressure (MAP), and Borg Exertion Scale. CPR quality measures included total number of compressions and number of adequate compressions (depth ≥5 cm). Sixty-three participants were enrolled: mean age 70.8 years, female 66.7%, past CPR training 60.3%. Bystander fatigue was similar between CPR methods: mean difference in HR -0.59 (95% CI -3.51-2.33), MAP 1.64 (95% CI -0.23-3.50), and Borg 0.46 (95% CI 0.07-0.84). Compared to 30:2, participants using CCC performed more chest compressions (480.0 v. 376.3, mean difference 107.7; pCPR quality decreased significantly faster when performing CCC compared to 30:2. However, performing CCC produced more adequate compressions overall with a similar level of fatigue compared to the 30:2 method.

  12. Dental Students’ Preference with regard to Tactile or Visual Determination of Injection Site for an Inferior Alveolar Nerve Block in Children: A Crossover Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Nahid Ramazani

    2016-08-01

    Full Text Available Objectives: Instruction of local anesthesia injection in an important part of dental education curricula. This study was performed to compare dental students’ preference with regard to tactile or visual determination of injection site for an inferior alveolar nerve block (IANB in children.Materials and Methods: This crossover randomized clinical trial was conducted on dental students of Zahedan Dental School who took the first practical course of pediatric dentistry in the first academic semester of 2013-14 (n=42. They were randomly divided into two groups. During the first phase, group I was instructed to find the needle insertion point for an IANB via tactile method and group II was instructed to do it visually. In the second phase, the groups received instructions for the alternate technique. Both instructions were done using live demonstrations by the same instructor and immediately after instruction the learners practiced an IANB using the taught method. A five-point Likert scale questionnaire was then filled out by the students. The preference score was determined by calculating the mean of item scores. Data were analyzed using Mann-Whitney U and Wilcoxon Singed Rank tests in SPSS 19 at P=0.05 level of significance.Results: Thirty-eight students completed the study. By using the visual method to perform an IANB, students gained a significantly higher mean preference score (P=0.020. There was a significant difference in the preference of male students (P=0.008.Conclusions: Instruction of IANB by visual identification of needle insertion point is more desirable by students. 

  13. A double blind randomized placebo control crossover trial on the effect of dietary nitrate supplementation on exercise tolerance in stable moderate chronic obstructive pulmonary disease.

    Science.gov (United States)

    Leong, Paul; Basham, Jane E; Yong, Theresa; Chazan, Adrian; Finlay, Paul; Barnes, Sara; Bardin, Phillip G; Campbell, Donald

    2015-05-02

    Dietary nitrate supplementation has been shown to decrease the oxygen cost of exercise and prolong exercise tolerance, as measured by sub-maximal exercise endurance distance and time at 85% V̇O2max, in both elite athletes and normal healthy subjects. Patients with chronic obstructive pulmonary disease (COPD) have reduced quality of life and ability to perform activities of daily living attributable to diminished exercise tolerance, and dietary nitrate may be able to ameliorate this. We performed a double-blind, computer-randomized placebo control crossover trial at a tertiary Australian hospital to investigate whether dietary nitrate supplementation as beetroot juice (BR) would augment submaximal exercise endurance in individuals with spirometrically confirmed stable moderate COPD. Volunteers underwent an incremental shuttle walk test to determine V̇O2max followed by a test dose of BR to establish safety in the study population. Participants performed an endurance shuttle walk test (ESWT) at 85% V̇O2max after randomization to either a 3 day wash-in of BR (4.8 mmol twice a day) or placebo (nitrate deplete BR), with a final dose on the morning of testing. They then crossed over after 4 day washout. Repeated measures two sided paired t-tests were employed. 35 participants were recruited with 19 completing the trial. In the initial safety phase, we measured systolic blood pressure over four hours post first dose of BR, and found a mean 10 mmHg decrement maximal at 1 hour. One individual developed symptomatic postural hypotension and was excluded. The primary outcomes of ESWT distance and time to fatigue improved by 11% and 6% respectively; however these differences did not achieve statistical significance (p = 0.494 and 0.693 respectively). Our study does not support a role for routine dietary nitrate supplementation for enhancement of exercise endurance in COPD. Australia and New Zealand Clinical Trial Register: ACTRN12611001088932.

  14. 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.

  15. Lercanidipine, enalapril and their combination in the treatment of elderly hypertensive patients: placebo-controlled, randomized, crossover study with four ABPM.

    Science.gov (United States)

    Puig, J G; Calvo, C; Luurila, O; Luurila, H; Sulosaari, S; Strandberg, A; Ghezzi, C

    2007-12-01

    This double-blind, placebo-controlled, four-way balanced design crossover study included hypertensive patients aged 60-85 years with mean office-measured sitting systolic blood pressure (SBP) 160-179 mm Hg and daytime SBP > or =135 mm Hg. After a 2-week run-in period, during which previous medications were discontinued, each patient received the following four treatments in randomized order for 4 weeks each: lercanidipine 10 mg (L), enalapril 20 mg (E), lercanidipine 10 mg plus enalapril 20 mg (L/E) and placebo (P). At the end of each treatment period, office trough blood pressure (BP) was measured and a 24-h Ambulatory Blood Pressure Monitoring (ABPM) was performed. Seventy-five patients (mean age 66 years, office BP 168/92 mm Hg, daytime SBP 151 mm Hg) were randomized and 62 completed the study with four valid post-baseline ABPMs. The administration of P, L, E and L/E was associated with a mean 24-h SBP of 144, 137, 133 and 127 mm Hg, respectively. All active treatments significantly reduced the mean 24-h SBP in comparison with placebo, but L/E was significantly more effective than L and E alone. Similarly, office SBP was significantly more reduced with L/E (-16.9 mm Hg) than with L (-5.0 mm Hg) or E (-5.9 mm Hg). A BP <140/90 mm Hg was recorded in 18% of patients with L, 19% with E and 45% with L/E. Two patients on P and two on L/E were withdrawn from the study due to adverse events. In conclusion, combination therapy with L/E has additive antihypertensive effects on both ambulatory and office BP in elderly patients and is well tolerated.

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

    Directory of Open Access Journals (Sweden)

    Pleun C M van Poppel

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

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

    Science.gov (United States)

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

    2014-12-01

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

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

    Science.gov (United States)

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

    2012-07-01

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

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

    Science.gov (United States)

    Whittaker, Anne; Dinu, Monica; Cesari, Francesca; Gori, Anna Maria; Fiorillo, Claudia; Becatti, Matteo; Casini, Alessandro; Marcucci, Rossella; Benedettelli, Stefano; Sofi, Francesco

    2017-04-01

    The aim of the present study was to examine whether a replacement diet with products made with organic ancient khorasan wheat could provide additive protective effects in reducing glucose, insulin, lipid and inflammatory risk factors, and in restoring blood redox balance in type 2 diabetes mellitus (T2DM) patients compared to diet with product made with modern organic wheat. We conducted a randomized, double-blinded crossover trial with two intervention phases on 21 T2DM patients (14 females, 7 males). The participants were assigned to consume products (bread, pasta, crackers and biscuits) made using semi-whole flour from organic wheat that was either from ancient khorasan wheat or modern control wheat for 8 weeks in a random order. An 8-week washout period was implemented between the interventions. Laboratory analyses were performed both at the beginning and at the end of each intervention phase. The metabolic risk profile improved only after the khorasan intervention period, as measured by a reduction in total and LDL cholesterol (mean reduction: -3.7 and -3.4 %, respectively), insulin (-16.3 %) and blood glucose (-9.1 %). Similarly, there was a significant reduction in circulating levels of reactive oxygen species (ROS), vascular endothelial growth factor (VEGF) and interleukin-1ra, and a significant increase of total antioxidant capacity (+6.3 %). No significant differences from baseline were noted after the modern control wheat intervention phase. The change (from pre- to post-intervention) between the two intervention arms was significantly different (p diet with ancient khorasan wheat consumption provided additive protection in reducing total and LDL cholesterol, insulin, blood glucose, ROS production, and some inflammatory risk factors, which are all key factors warranting of control in secondary prevention of T2DM compared to a diet with products made with modern wheat.

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

    Directory of Open Access Journals (Sweden)

    Fabian M Stuby

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

  1. Residual gastric volume evaluation with ultrasonography after ingestion of carbohydrate- or carbohydrate plus glutamine-enriched beverages: a randomized, crossover clinical trial with healthy volunteers.

    Science.gov (United States)

    Gomes, Paulo Cesar; Caporossi, Cervantes; Aguilar-Nascimento, Jose Eduardo; Silva, Ageo Mario Candido da; Araujo, Viviane Maeve Tavares de

    2017-01-01

    - Abbreviation of preoperative fasting to 2 hours with maltodextrin (CHO)-enriched beverage is a safe procedure and may enhance postoperative recovery. Addition of glutamine (GLN) to CHO beverages may include potential benefits to the metabolism. However, by adding a nitrogenous source to CHO beverages, gastric emptying may be delayed and increase the risk of bronchoaspiration during anesthesia. - In this study of safety, we aimed at investigating the residual gastric volume (RGV) 2 hours after the intake of either CHO beverage alone or CHO beverage combined with GLN. - We performed a randomized, crossover clinical trial. We assessed RGV by means of abdominal ultrasonography (US) in 20 healthy volunteers (10 males and 10 females) after an overnight fast of 8 hours. Then, they were randomized to receive 600 mL (400 mL immediately after US followed by another 200 mL 2 hours afterwards) of either CHO (12.5% maltodextrin) or CHO-GLN (12.5% maltodextrin plus 15 g GLN). Two sequential US evaluations were done at 120 and 180 minutes after ingestion of the second dose. The interval of time between ingestion of the two types of beverages was 2 weeks. - The mean (SD) RGV observed after 8 hours fasting (13.56±13.25 mL) did not statistically differ (P>0.05) from the RGV observed after ingesting CHO beverage at both 120 (16.32±11.78 mL) and 180 minutes (14.60±10.39 mL). The RGV obtained at 120 (15.63±18.83 mL) and 180 (13.65±10.27 mL) minutes after CHO-GLN beverage also was not significantly different from the fasting condition. - The RGV at 120 and 180 minutes after ingestion of CHO beverage combined with GLN is similar to that observed after an overnight fast.

  2. Effects of a Gentle, Self-Administered Stimulation of Perineal Skin for Nocturia in Elderly Women: A Randomized, Placebo-Controlled, Double-Blind Crossover Trial.

    Directory of Open Access Journals (Sweden)

    Kaori Iimura

    Full Text Available Somatic afferent nerve stimuli are used for treating an overactive bladder (OAB, a major cause of nocturia in the elderly. Clinical evidence for this treatment is insufficient because of the lack of appropriate control stimuli. Recent studies on anesthetized animals show that gentle stimuli applied to perineal skin with a roller could inhibit micturition contractions depending on the roller's surface material. We examined the efficacy of gentle skin stimuli for treating nocturia.The study was a cross-over, placebo-controlled, double-blind randomized clinical study using two rollers with different effects on micturition contractions. Participants were elderly women (79-89 years with nocturia. Active (soft elastomer roller or placebo (hard polystyrene roller stimuli were applied to perineal skin by participants for 1 min at bedtime. A 3-day baseline assessment period was followed by 3-day stimulation and 4-day resting periods, after which the participants were subjected to other stimuli for another 3 days. The primary outcome was change in the frequency of nighttime urination, for which charts were maintained during each 3-day period.Twenty-four participants were randomized, of which 22 completed all study protocols. One participant discontinued treatment because of an adverse event (abdominal discomfort. In participants with OAB (n = 9, change from baseline in the mean frequency of urination per night during the active stimuli period (mean ± standard deviation, -0.74 ± 0.7 times was significantly greater than that during placebo stimuli periods (-0.15 ± 0.8 times [p < 0.05]. In contrast, this difference was not observed in participants without OAB (n = 13.These results suggest that gentle perineal stimulation with an elastomer roller is effective for treating OAB-associated nocturia in elderly women. Here the limitation was a study period too short to assess changes in the quality of sleep and life.UMIN Clinical Trial Registry (CTR UMIN

  3. The effect of soy phytoestrogen supplementation on thyroid status and cardiovascular risk markers in patients with subclinical hypothyroidism: a randomized, double-blind, crossover study.

    Science.gov (United States)

    Sathyapalan, Thozhukat; Manuchehri, Alireza M; Thatcher, Natalie J; Rigby, Alan S; Chapman, Tom; Kilpatrick, Eric S; Atkin, Stephen L

    2011-05-01

    There is concern whether soy phytoestrogens may affect thyroid function. If true, soy phytoestrogens may be expected to have a greater impact in subjects with subclinical hypothyroidism. The primary aim was to determine the effect of soy phytoestrogen supplementation on thyroid function, with a secondary aim of assessing the effects on cardiovascular risk indices in patients with subclinical hypothyroidism. We conducted a randomized, double-blind, crossover study in a tertiary care setting. Sixty patients with subclinical hypothyroidism participated in the study. Patients were randomly assigned to either low-dose phytoestrogen (30 g soy protein with 2 mg phytoestrogens, representative of a Western diet) or high-dose phytoestrogen (30 g soy protein with 16 mg phytoestrogens, representative of a vegetarian diet) supplementation for 8 wk, then crossed over after an 8-wk washout period. The primary outcome was progression to overt hypothyroidism, with secondary outcome measures of blood pressure, insulin resistance, lipids, and highly sensitive C-reactive protein (hsCRP). Six female patients in the study progressed into overt hypothyroidism with a standardized rate ratio of 3.6 (95% confidence interval, 1.9, 6.2) after 16-mg phytoestrogen supplementation. Both systolic and diastolic blood pressure decreased with 16 mg phytoestrogens, whereas systolic pressure alone decreased with 2 mg phytoestrogens. Insulin resistance (homeostasis model assessment of insulin resistance, 3.5 ± 0.09 vs. 2.6 ± 0.08; P < 0.02) and hsCRP (4.9 ± 0.04 vs. 3.9 ± 0.03; P < 0.01) decreased with 16 mg phytoestrogens. Lipid profile remained unchanged. There is a 3-fold increased risk of developing overt hypothyroidism with dietary supplementation of 16 mg soy phytoestrogens with subclinical hypothyroidism. However, 16-mg soy phytoestrogen supplementation significantly reduces the insulin resistance, hsCRP, and blood pressure in these patients.

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

    Science.gov (United States)

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

    2011-01-01

    To compare PubMed Clinical Queries and UpToDate regarding the amount and speed of information retrieval and users' satisfaction. A cross-over randomized trial was conducted in February 2009 in Tehran University of Medical Sciences that included 44 year-one or two residents who participated in an information mastery workshop. A one-hour lecture on the principles of information mastery was organized followed by self learning slide shows before using each database. Subsequently, participants were randomly assigned to answer 2 clinical scenarios using either UpToDate or PubMed Clinical Queries then crossed to use the other database to answer 2 different clinical scenarios. The proportion of relevantly answered clinical scenarios, time to answer retrieval, and users' satisfaction were measured in each database. Based on intention-to-treat analysis, participants retrieved the answer of 67 (76%) questions using UpToDate and 38 (43%) questions using PubMed Clinical Queries (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.

  5. 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.

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

    Science.gov (United States)

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

    2016-08-01

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

  7. Residual gastric volume evaluation with ultrasonography after ingestion of carbohydrate- or carbohydrate plus glutamine-enriched beverages: a randomized, crossover clinical trial with healthy volunteers

    Directory of Open Access Journals (Sweden)

    Paulo Cesar GOMES

    Full Text Available ABSTRACT BACKGROUND Abbreviation of preoperative fasting to 2 hours with maltodextrin (CHO-enriched beverage is a safe procedure and may enhance postoperative recovery. Addition of glutamine (GLN to CHO beverages may include potential benefits to the metabolism. However, by adding a nitrogenous source to CHO beverages, gastric emptying may be delayed and increase the risk of bronchoaspiration during anesthesia. OBJECTIVE In this study of safety, we aimed at investigating the residual gastric volume (RGV 2 hours after the intake of either CHO beverage alone or CHO beverage combined with GLN. METHODS We performed a randomized, crossover clinical trial. We assessed RGV by means of abdominal ultrasonography (US in 20 healthy volunteers (10 males and 10 females after an overnight fast of 8 hours. Then, they were randomized to receive 600 mL (400 mL immediately after US followed by another 200 mL 2 hours afterwards of either CHO (12.5% maltodextrin or CHO-GLN (12.5% maltodextrin plus 15 g GLN. Two sequential US evaluations were done at 120 and 180 minutes after ingestion of the second dose. The interval of time between ingestion of the two types of beverages was 2 weeks. RESULTS The mean (SD RGV observed after 8 hours fasting (13.56±13.25 mL did not statistically differ (P>0.05 from the RGV observed after ingesting CHO beverage at both 120 (16.32±11.78 mL and 180 minutes (14.60±10.39 mL. The RGV obtained at 120 (15.63±18.83 mL and 180 (13.65±10.27 mL minutes after CHO-GLN beverage also was not significantly different from the fasting condition. CONCLUSION The RGV at 120 and 180 minutes after ingestion of CHO beverage combined with GLN is similar to that observed after an overnight fast.

  8. Effects of Traditional and Pyramidal Resistance Training Systems on Muscular Strength, Muscle Mass, and Hormonal Responses in Older Women: A Randomized Crossover Trial.

    Science.gov (United States)

    Ribeiro, Alex S; Schoenfeld, Brad J; Fleck, Steven J; Pina, Fábio L C; Nascimento, Matheus A; Cyrino, Edilson S

    2017-07-01

    Ribeiro, AS, Schoenfeld, BJ, Fleck, SJ, Pina, FLC, Nascimento, MA, and Cyrino, ES. Effects of traditional and pyramidal resistance training systems on muscular strength, muscle mass, and hormonal responses in older women: a randomized crossover trial. J Strength Cond Res 31(7): 1888-1896, 2017-The purpose of this study was to investigate the effect of resistance training (RT) performed in a pyramid (PR) versus a traditional (TD) system on muscular strength, muscle mass, and hormonal responses in older women. Twenty-five older women (67.6 ± 5.1 years, 65.9 ± 11.1 kg, 154.7 ± 5.8 cm, and 27.5 ± 4.5 kg·m) performed both a TD and PR system RT program in a balanced crossover design. The TD program consisted of 3 sets of 8-12 repetition maximum (RM) with a constant load for the 3 sets, whereas the PR system consisted of 3 sets of 12/10/8-RM with incrementally higher loads for each set. Training was performed in 2 phases of 8 weeks each, with a 12-week washout between the 8-week phases. One repetition maximum (1RM) tests were used as measures of muscular strength. Dual X-ray absorptiometry was used to estimate skeletal muscle mass. Testosterone and IGF-1 concentrations were determined preintervention and postintervention after 12 hours fasting. Significant (p ≤ 0.05) increases were observed in both groups for muscular strength in the 1RM chest press (TD = 12.4% and effect size [ES] = 0.86 vs. PR = 11.5% and ES = 0.74), knee extension (TD = 12.5% and ES = 0.61 vs. PR = 11.8% and ES = 0.62), preacher curl (TD = 10.9% and ES = 0.63 vs. PR = 8.6% and ES = 0.54), and for skeletal muscle mass (TD = 3.6% and ES = 0.32 vs. PR = 2.4% and ES = 0.24) with no differences between groups. There were no significant (p > 0.05) main effects for IGF-1 and testosterone. The results suggest that the PR and TD systems performed are similarly effective for promoting positive adaptations in muscular strength and hypertrophy in older women.

  9. Concord grape juice, cognitive function, and driving performance: a 12-wk, placebo-controlled, randomized crossover trial in mothers of preteen children.

    Science.gov (United States)

    Lamport, Daniel J; Lawton, Clare L; Merat, Natasha; Jamson, Hamish; Myrissa, Kyriaki; Hofman, Denise; Chadwick, Helen K; Quadt, Frits; Wightman, JoLynne D; Dye, Louise

    2016-03-01

    Daily consumption of Concord grape juice (CGJ) over 3-4 mo has been shown to improve memory function in adults with mild cognitive impairment and reduce blood pressure in hypertensive adults. These benefits likely result from the high concentration of polyphenols in CGJ. Increased stress can impair cognitive function and elevate blood pressure. Thus, we examined the potential beneficial effect of CGJ in individuals with somewhat stressful and demanding lifestyles. We sought to examine the effects of the daily consumption of CGJ for 12 wk on cognitive function, driving performance, and blood pressure in healthy, middle-aged working mothers. Twenty-five healthy mothers (aged 40-50 y) of preteen children who were employed for ≥30 h/wk consumed 12 ounces (355 mL) of either CGJ (containing 777 mg total polyphenols) or an energy-, taste-, and appearance-matched placebo daily for 12 wk according to a randomized crossover design with a 4-wk washout. Verbal and spatial memory, executive function, attention, blood pressure, and mood were assessed at baseline and at 6 and 12 wk. Immediately after the cognitive battery, a subsample of 17 women completed a driving performance assessment at the University of Leeds Driving Simulator. The 25-min driving task required participants to match the speed and direction of a lead vehicle. Significant improvements in immediate spatial memory and driving performance were observed after CGJ relative to placebo. There was evidence of an enduring effect of CGJ such that participants who received CGJ in arm 1 maintained better performance in the placebo arm. Cognitive benefits associated with the long-term consumption of flavonoid-rich grape juice are not exclusive to adults with mild cognitive impairment. Moreover, these cognitive benefits are apparent in complex everyday tasks such as driving. Effects may persist beyond the cessation of flavonoid consumption, and future studies should carefully consider the length of washout within

  10. The randomized crossover comparison of airway sealing with the laryngeal mask airway Supreme(™) at three different intracuff pressures in children.

    Science.gov (United States)

    Choi, Kwan-Woong; Lee, Jeong-Rim; Oh, Jung-Tak; Kim, Dong Wook; Kim, Min-Soo

    2014-10-01

    An intracuff pressure of 80 cm H2 O in the adult-sized laryngeal mask airway Supreme has been recommended to obtain a higher oropharyngeal leak pressure (OLP). However, the intracuff pressure for the higher OLP in the pediatric laryngeal mask airway Supreme could be different from that in the adult-sized laryngeal mask airway Supreme. Thus, we measured and compared OLP at three intracuff pressures of 40, 60, and 80 cm H2 O in the pediatric laryngeal mask airway Supreme. This study was designed as a randomized crossover study and enrolled 36 children, aged 0-108 months and 5-30 kg in weight. After insertion of the laryngeal mask airway Supreme, oropharyngeal leak pressure (OLP) was measured at intracuff pressures of 40, 60, and 80 cm H2 O according to one of six sequences produced on the basis of 3 × 6 Williams crossover design. During the intraoperative period, the laryngeal mask airway Supreme was maintained using the last intracuff pressure of the allocated sequence. The intraoperative and postoperative complications were compared among three maintenance intracuff pressures. OLP at the intracuff pressure of 60 cm H2 O was significantly higher than that of 40 cm H2 O (17.9 ± 3.9 vs 16.9 ± 4.2 cm H2 O, P = 0.004) and was comparable with that of 80 cm H2 O (17.9 ± 3.9 vs 17.8 ± 4.6 cm H2 O, P = 0.938). There were no significant differences of intraoperative and postoperative complications among the three maintenance intracuff pressures. Our results suggest that the use of an intracuff pressure of 60 cm H2 O in pediatric laryngeal mask airway Supreme provides a higher OLP compared with 40 cm H2 O. © 2014 John Wiley & Sons Ltd.

  11. Effectiveness of breathing through nasal and oral routes in unconscious apneic adult human subjects: a prospective randomized crossover trial.

    Science.gov (United States)

    Jiang, Yandong; Bao, Fang Ping; Liang, Yafen; Kimball, William R; Liu, Yanhong; Zapol, Warren M; Kacmarek, Robert M

    2011-07-01

    The authors hypothesized that mouth ventilation by a resuscitator via the nasal route ensures a more patent airway and more effective ventilation than does ventilation via the oral route and therefore would be the optimal manner to ventilate adult patients in emergencies, such as during cardiopulmonary resuscitation. They tested the hypothesis by comparing the effectiveness of mouth-to-nose breathing (MNB) and mouth-to-mouth breathing (MMB) in anesthetized, apneic, adult subjects without muscle paralysis. Twenty subjects under general anesthesia randomly received MMB and MNB with their heads placed first in a neutral position and then an extended position. A single operator performed MNB and MMB at the target breathing rate of 10 breaths/min, inspiratory:expiratory ratio 1:2 and peak inspiratory airway pressure 24 cm H₂O. A plethysmograph was used to measure the amplitude change during MMB and MNB. The inspiratory and expiratory tidal volumes during MMB and MNB were calculated retrospectively using the calibration curve. All data are presented as medians (interquartile ranges). The rates of effective ventilation (expired volume > estimated anatomic dead space) during MNB and MMB were 91.1% (42.4-100%) and 43.1% (42.5-100%) (P breathing technique during emergency situations will improve patient outcomes.

  12. Efficacy of walking aids on self-paced outdoor walking in individuals with COPD: A randomized cross-over trial.

    Science.gov (United States)

    Vaes, Anouk W; Meijer, Kenneth; Delbressine, Jeannet M; Wiechert, Jozé; Willems, Paul; Wouters, Emiel F M; Franssen, Frits M E; Spruit, Martijn A

    2015-08-01

    Walking aids, such as rollator or draisine, improve mobility and functional exercise performance in individuals with chronic obstructive pulmonary disease (COPD) during an indoor 6-min walk test. However, this test does not reflect everyday walking, which is the most frequently reported problematic activity of daily life in individuals with COPD. To date, efficacy of walking aids during self-paced outdoor walking remains unknown. Therefore, we aimed to determine the efficacy of a rollator and draisine on self-paced outdoor walking in individuals with COPD. Fifteen individuals with COPD (68% men; age: 63 ± 8 years; forced expiratory volume in 1 s: 40 ± 14% predicted) performed three self-paced outdoor walking tests on two consecutive days: test 1 unaided, and tests 2 and 3 with rollator or draisine in random order. Participants had to walk as long as possible at their own pace. The test ended when participants needed to stop, with a maximum duration of 30 min. The use of rollator resulted in the highest walk distance and time (P walked significantly further and longer during an unaided test compared with a draisine aided test (P walking speed, fewer strides, greater stride length, and higher step and stride variability (P walk distance and time in individuals with moderate and advanced COPD and a poor functional exercise capacity, whereas the use of a draisine had a detrimental effect compared with unaided walking. © 2015 Asian Pacific Society of Respirology.

  13. Post-Exercise Hypotension and Its Mechanisms Differ after Morning and Evening Exercise: A Randomized Crossover Study.

    Science.gov (United States)

    de Brito, Leandro C; Rezende, Rafael A; da Silva Junior, Natan D; Tinucci, Tais; Casarini, Dulce E; Cipolla-Neto, José; Forjaz, Cláudia L M

    2015-01-01

    Post-exercise hypotension (PEH), calculated by the difference between post and pre-exercise values, it is greater after exercise performed in the evening than the morning. However, the hypotensive effect of morning exercise may be masked by the morning circadian increase in blood pressure. This study investigated PEH and its hemodynamic and autonomic mechanisms after sessions of aerobic exercise performed in the morning and evening, controlling for responses observed after control sessions performed at the same times of day. Sixteen pre-hypertensive men underwent four sessions (random order): two conducted in the morning (7:30 am) and two in the evening (5 pm). At each time of day, subjects underwent an exercise (cycling, 45 min, 50%VO2peak) and a control (sitting rest) session. Measurements were taken pre- and post-interventions in all the sessions. The net effects of exercise were calculated for each time of day by [(post-pre exercise)-(post-pre control)] and were compared by paired t-test (Pmorning exercise (-7±3 vs. -3±4 mmHg, Pmorning (-460±771 ml/min, Pmorning than in the evening (+7±5 vs. +10±5 bpm, Pmorning exercise when circadian variations are considered. This greater effect is accompanied by a reduction of cardiac output due to a smaller increase in heart rate and cardiac sympathovagal balance.

  14. Test-retest of computerized health status questionnaires frequently used in the monitoring of knee osteoarthritis: a randomized crossover trial

    DEFF Research Database (Denmark)

    Gudbergsen, Henrik; Bartels, Else M; Krusager, Peter

    2011-01-01

    ABSTRACT: BACKGROUND: To compare data based on touch screen to data based on traditional paper versions of questionnaires frequently used to examine patient reported outcomes in knee osteoarthritis patients and to examine the impact of patient characteristics on this comparison METHODS: Participa......ABSTRACT: BACKGROUND: To compare data based on touch screen to data based on traditional paper versions of questionnaires frequently used to examine patient reported outcomes in knee osteoarthritis patients and to examine the impact of patient characteristics on this comparison METHODS......: Participants were recruited from an ongoing trial (ClinicalTrials.Gov Identifier: NCT00655941). 20 female participants, mean age 67 (SD 7), completed KOOS, VAS pain, function and patient global, SF-36, Physical Activity Scale, painDETECT, and the ADL Taxonomy. Patients were randomly assigned to one of two.......99. Analysis revealed a statistically significant difference between versions of the ADL Taxonomy, but not for the remaining questionnaires. Age, computer experience or education-level had no significant impact on the results. The computerized questionnaires were reported to be easier to use. CONCLUSION...

  15. Test-retest of computerized health status questionnaires frequently used in the monitoring of knee osteoarthritis: a randomized crossover trial

    Directory of Open Access Journals (Sweden)

    Christensen Robin

    2011-08-01

    Full Text Available Abstract Background To compare data based on touch screen to data based on traditional paper versions of questionnaires frequently used to examine patient reported outcomes in knee osteoarthritis patients and to examine the impact of patient characteristics on this comparison Methods Participants were recruited from an ongoing trial (http://ClinicalTrials.Gov Identifier: NCT00655941. 20 female participants, mean age 67 (SD 7, completed KOOS, VAS pain, function and patient global, SF-36, Physical Activity Scale, painDETECT, and the ADL Taxonomy. Patients were randomly assigned to one of two subgroups, completing either the paper or touch screen version first. Mean, mean differences (95% CI, median, median differences and Intraclass Correlation Coefficients (ICCs were calculated for all questionnaires. Results ICCs between data based on computerized and paper versions ranged from 0.86 to 0.99. Analysis revealed a statistically significant difference between versions of the ADL Taxonomy, but not for the remaining questionnaires. Age, computer experience or education-level had no significant impact on the results. The computerized questionnaires were reported to be easier to use. Conclusion The computerized questionnaires gave comparable results to answers given on paper. Patient characteristics did not influence results and implementation was feasible.

  16. Effects of chocolate milk consumption on markers of muscle recovery following soccer training: a randomized cross-over study

    Directory of Open Access Journals (Sweden)

    Womack Christopher J

    2010-05-01

    Full Text Available Abstract Background The efficacy of chocolate milk (CM as a recovery beverage following a period of increased training duration (ITD was studied in intercollegiate soccer players. Methods 13 subjects completed one week of normal 'baseline' training followed by four days of ITD. After each day of ITD, subjects received either a high-carbohydrate (504 kcal; CHO: 122 g; 2 g Fat or isocaloric CM (504 kcal; 84 g CHO; 28 g Pro; 7 g Fat recovery beverage. Serum creatine kinase (CK, myoglobin (Mb, muscle soreness, fatigue ratings and isometric quadriceps force (MVC were obtained prior to ITD, and following 2- and 4-days of ITD. Performance tests (T-drill, vertical jump were performed within training sessions. Treatments were administered in a randomly counterbalanced protocol, and subjects repeated the procedures with the alternate beverage following a two-week washout period. Results Mean daily training time and HR increased (p -1 compared to CHO (431.6 ± 310.8 U·L-1. No treatment differences were observed for the performance tests. Conclusions Post-exercise CM provided similar muscle recovery responses to an isocaloric CHO beverage during four-days of ITD. Future studies should investigate if the attenuated CK levels observed with CM have functional significance during more demanding periods of training.

  17. Searching for answers to clinical questions using google versus evidence-based summary resources: a randomized controlled crossover study.

    Science.gov (United States)

    Kim, Sarang; Noveck, Helaine; Galt, James; Hogshire, Lauren; Willett, Laura; O'Rourke, Kerry

    2014-06-01

    To compare the speed and accuracy of answering clinical questions using Google versus summary resources. In 2011 and 2012, 48 internal medicine interns from two classes at Rutgers University Robert Wood Johnson Medical School, who had been trained to use three evidence-based summary resources, performed four-minute computer searches to answer 10 clinical questions. Half were randomized to initiate searches for answers to questions 1 to 5 using Google; the other half initiated searches using a summary resource. They then crossed over and used the other resource for questions 6 to 10. They documented the time spent searching and the resource where the answer was found. Time to correct response and percentage of correct responses were compared between groups using t test and general estimating equations. Of 480 questions administered, interns found answers for 393 (82%). Interns initiating searches in Google used a wider variety of resources than those starting with summary resources. No significant difference was found in mean time to correct response (138.5 seconds for Google versus 136.1 seconds for summary resource; P = .72). Mean correct response rate was 58.4% for Google versus 61.5% for summary resource (mean difference -3.1%; 95% CI -10.3% to 4.2%; P = .40). The authors found no significant differences in speed or accuracy between searches initiated using Google versus summary resources. Although summary resources are considered to provide the highest quality of evidence, improvements to allow for better speed and accuracy are needed.

  18. Crossover Designs in Nutrition and Dietetics Research.

    Science.gov (United States)

    Harris, Jeffrey E; Raynor, Hollie A

    2017-07-01

    This article is the 12th installment in a statistical series exploring the importance of research design, epidemiologic methods, and statistical analysis as applied to nutrition and dietetics research. The purpose of this series is to assist registered dietitian nutritionists in interpreting nutrition research and aid nutrition researchers in applying scientific principles to produce high-quality nutrition research. This article focuses on the use of crossover designs in nutrition and dietetics research. The purpose is to distinguish the crossover design from the randomized clinical trial, define important terms, illustrate a 2×2 crossover design, discuss potential confounding variables in the crossover design, describe the analysis and interpretation of crossover data, present sample size considerations, provide examples of the use of the crossover design in nutrition and dietetics, and discuss additional considerations when the independent variable has more than two levels. Copyright © 2017 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

  19. Does experimental low back pain change posteroanterior lumbar spinal stiffness and trunk muscle activity? A randomized crossover study.

    Science.gov (United States)

    Wong, Arnold Y L; Parent, Eric C; Prasad, Narasimha; Huang, Christopher; Chan, K Ming; Kawchuk, Gregory N

    2016-05-01

    While some patients with low back pain demonstrate increased spinal stiffness that decreases as pain subsides, this observation is inconsistent. Currently, the relation between spinal stiffness and low back pain remains unclear. This study aimed to investigate the effects of experimental low back pain on temporal changes in posteroanterior spinal stiffness and concurrent trunk muscle activity. In separate sessions five days apart, nine asymptomatic participants received equal volume injections of hypertonic or isotonic saline in random order into the L3-L5 interspinous ligaments. Pain intensity, spinal stiffness (global and terminal stiffness) at the L3 level, and the surface electromyographic activity of six trunk muscles were measured before, immediately after, and 25-minute after injections. These outcome measures under different saline conditions were compared by generalized estimating equations. Compared to isotonic saline injections, hypertonic saline injections evoked significantly higher pain intensity (mean difference: 5.7/10), higher global (mean difference: 0.73N/mm) and terminal stiffness (mean difference: 0.58N/mm), and increased activity of four trunk muscles during indentation (Ppain subsided. While previous clinical research reported inconsistent findings regarding the association between spinal stiffness and low back pain, our study revealed that experimental pain caused temporary increases in spinal stiffness and concurrent trunk muscle co-contraction during indentation, which helps explain the temporal relation between spinal stiffness and low back pain observed in some clinical studies. Our results substantiate the role of spinal stiffness assessments in monitoring back pain progression. Copyright © 2016 Elsevier Ltd. All rights reserved.

  20. Regulation of Lipolysis and Adipose Tissue Signaling during Acute Endotoxin-Induced Inflammation: A Human Randomized Crossover Trial.

    Directory of Open Access Journals (Sweden)

    Nikolaj Rittig

    Full Text Available Lipolysis is accelerated during the acute phase of inflammation, a process being regulated by pro-inflammatory cytokines (e.g. TNF-α, stress-hormones, and insulin. The intracellular mechanisms remain elusive and we therefore measured pro- and anti-lipolytic signaling pathways in adipocytes after in vivo endotoxin exposure.Eight healthy, lean, male subjects were investigated using a randomized cross over trial with two interventions: i bolus injection of saline (Placebo and ii bolus injection of lipopolysaccharide endotoxin (LPS. A 3H-palmitate tracer was used to measure palmitate rate of appearance (Rapalmitate and indirect calorimetry was performed to measure energy expenditures and lipid oxidation rates. A subcutaneous abdominal fat biopsy was obtained during both interventions and subjected to western blotting and qPCR quantifications.LPS caused a mean increase in serum free fatty acids (FFA concentrations of 90% (CI-95%: 37-142, p = 0.005, a median increase in Rapalmitate of 117% (CI-95%: 77-166, p<0.001, a mean increase in lipid oxidation of 49% (CI-95%: 1-96, p = 0.047, and a median increase in energy expenditure of 28% (CI-95%: 16-42, p = 0.001 compared with Placebo. These effects were associated with increased phosphorylation of hormone sensitive lipase (pHSL at ser650 in adipose tissue (p = 0.03, a trend towards elevated pHSL at ser552 (p = 0.09 and cAMP-dependent protein kinase A (PKA phosphorylation of perilipin 1 (PLIN1 (p = 0.09. Phosphatase and tensin homolog (PTEN also tended to increase (p = 0.08 while phosphorylation of Akt at Thr308 tended to decrease (p = 0.09 during LPS compared with Placebo. There was no difference between protein or mRNA expression of ATGL, G0S2, and CGI-58.LPS stimulated lipolysis in adipose tissue and is associated with increased pHSL and signs of increased PLIN1 phosphorylation combined with a trend toward decreased insulin signaling. The combination of these mechanisms appear to be the driving forces

  1. Post-Exercise Hypotension and Its Mechanisms Differ after Morning and Evening Exercise: A Randomized Crossover Study.

    Directory of Open Access Journals (Sweden)

    Leandro C de Brito

    Full Text Available Post-exercise hypotension (PEH, calculated by the difference between post and pre-exercise values, it is greater after exercise performed in the evening than the morning. However, the hypotensive effect of morning exercise may be masked by the morning circadian increase in blood pressure. This study investigated PEH and its hemodynamic and autonomic mechanisms after sessions of aerobic exercise performed in the morning and evening, controlling for responses observed after control sessions performed at the same times of day. Sixteen pre-hypertensive men underwent four sessions (random order: two conducted in the morning (7:30 am and two in the evening (5 pm. At each time of day, subjects underwent an exercise (cycling, 45 min, 50%VO2peak and a control (sitting rest session. Measurements were taken pre- and post-interventions in all the sessions. The net effects of exercise were calculated for each time of day by [(post-pre exercise-(post-pre control] and were compared by paired t-test (P<0.05. Exercise hypotensive net effects (e.g., decreasing systolic, diastolic and mean blood pressure occurred at both times of day, but systolic blood pressure reductions were greater after morning exercise (-7±3 vs. -3±4 mmHg, P<0.05. Exercise decreased cardiac output only in the morning (-460±771 ml/min, P<0.05, while it decreased stroke volume similarly at both times of day and increased heart rate less in the morning than in the evening (+7±5 vs. +10±5 bpm, P<0.05. Only evening exercise increased sympathovagal balance (+1.5±1.6, P<0.05 and calf blood flow responses to reactive hyperemia (+120±179 vs. -70±188 U, P<0.05. In conclusion, PEH occurs after exercise conducted at both times of day, but the systolic hypotensive effect is greater after morning exercise when circadian variations are considered. This greater effect is accompanied by a reduction of cardiac output due to a smaller increase in heart rate and cardiac sympathovagal balance.

  2. High doses of clopidogrel to overcome genetic resistance: the randomized crossover CLOVIS-2 (Clopidogrel and Response Variability Investigation Study 2).

    Science.gov (United States)

    Collet, Jean-Philippe; Hulot, Jean-Sébastien; Anzaha, Ghalia; Pena, Ana; Chastre, Thomas; Caron, Claire; Silvain, Johanne; Cayla, Guillaume; Bellemain-Appaix, Anne; Vignalou, Jean-Baptiste; Galier, Sophie; Barthélémy, Olivier; Beygui, Farzin; Gallois, Vanessa; Montalescot, Gilles

    2011-04-01

    This study sought to determine whether the pharmacokinetic (PK) and pharmacodynamic (PD) responses to high or standard clopidogrel loading doses (LDs) differ according to CYP2C19*2 allele. CYP2C19 loss-of-function alleles are associated with reduced responsiveness to standard clopidogrel doses. Young post-myocardial infarction patients heterozygous (wild type [wt]/*2, n = 43) or homozygous (*2/*2, n = 8) for the CYP2C19*2 genetic variant were matched with patients not carrying the variant (wt/wt, n = 58). All patients were randomized to a 300- or 900-mg clopidogrel LD. The relative reduction in residual platelet aggregation (RR-RPA, %) and the area under the plasma concentration time curve of active metabolite from baseline to 6 h after loading (AUC(0-6)) were compared according to both LD and CYP2C19*2 carriage. The 300-mg LD led to a gene-dose effect for RR-RPA (-65.7% ± 35.9% in wt/wt vs. -48.0% ± 38.4% in wt/*2 vs. -14.6% ± 32.4% in *2/*2; overall p value = 0.003, p = 0.03 for wt/wt versus wt/*2, p = 0.04 for wt/*2 versus *2/*2) with minor effect in *2/*2 carriers. After the 900-mg LD, the effect of the CYP2C19*2 variant on platelet inhibition was fully compensated in wt/*2 carriers but not in *2/*2 carriers (-83.6% ± 25.8% in wt/wt vs.-77.2% ± 26.9% in wt/*2 vs. -29.5% ± 26.8% in *2/*2; overall p value = 0.0003, p = 0.20 for wt/wt versus wt/*2, p CLOVIS-2]; NCT00822666). Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  3. The impact of nurse-driven targeted HIV screening in 8 emergency departments: study protocol for the DICI-VIH cluster-randomized two-period crossover trial.

    Science.gov (United States)

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

    2016-02-01

    In 2010, to reduce late HIV diagnosis, the French national health agency endorsed non-targeted HIV screening in health care settings. Despite these recommendations, non-targeted screening has not been implemented and only physician-directed diagnostic testing is currently performed. A survey conducted in 2010 in 29 French Emergency Departments (EDs) showed that non-targeted nurse-driven screening was feasible though only a few new HIV diagnoses were identified, predominantly among high-risk groups. A strategy targeting high-risk groups combined with current practice could be shown to be feasible, more efficient and cost-effective than current practice alone. DICI-VIH (acronym for nurse-driven targeted HIV screening) is a multicentre, cluster-randomized, two-period crossover trial. The primary objective is to compare the effectiveness of 2 strategies for diagnosing HIV among adult patients visiting EDs: nurse-driven targeted HIV screening combined with current practice (physician-directed diagnostic testing) versus current practice alone. Main secondary objectives are to compare access to specialist consultation and how early HIV diagnosis occurs in the course of the disease between the 2 groups, and to evaluate the implementation, acceptability and cost-effectiveness of nurse-driven targeted screening. The 2 strategies take place during 2 randomly assigned periods in 8 EDs of metropolitan Paris, where 42 % of France's new HIV patients are diagnosed every year. All patients aged 18 to 64, not presenting secondary to HIV exposure are included. During the intervention period, patients are invited to fill a 7-item questionnaire (country of birth, sexual partners and injection drug use) in order to select individuals who are offered a rapid test. If the rapid test is reactive, a follow-up visit with an infectious disease specialist is scheduled within 72 h. Assuming an 80 % statistical power and a 5 % type 1 error, with 1.04 and 3.38 new diagnoses per 10,000 patients in

  4. A Web-Based Telehealth Training Platform Incorporating Automated Nonverbal Behavior Feedback for Teaching Communication Skills to Medical Students: A Randomized Crossover Study.

    Science.gov (United States)

    Liu, Chunfeng; Lim, Renee L; McCabe, Kathryn L; Taylor, Silas; Calvo, Rafael A

    2016-09-12

    In the interests of patient health outcomes, it is important for medical students to develop clinical communication skills. We previously proposed a telehealth communication skills training platform (EQClinic) with automated nonverbal behavior feedback for medical students, and it was able to improve medical students' awareness of their nonverbal communication. This study aimed to evaluate the effectiveness of EQClinic to improve clinical communication skills of medical students. We conducted a 2-group randomized crossover trial between February and June 2016. Participants were second-year medical students enrolled in a clinical communication skills course at an Australian university. Students were randomly allocated to complete online EQClinic training during weeks 1-5 (group A) or to complete EQClinic training during weeks 8-11 (group B). EQClinic delivered an automated visual presentation of students' nonverbal behavior coupled with human feedback from a standardized patient (SP). All students were offered two opportunities to complete face-to-face consultations with SPs. The two face-to-face consultations were conducted in weeks 6-7 and 12-13 for both groups, and were rated by tutors who were blinded to group allocation. Student-Patient Observed Communication Assessment (SOCA) was collected by blinded assessors (n=28) at 2 time points and also by an SP (n=83). Tutor-rated clinical communications skill in face-to-face consultations was the primary outcome and was assessed with the SOCA. We used t tests to examine the students' performance during face-to-face consultations pre- and postexposure to EQClinic. We randomly allocated 268 medical students to the 2 groups (group A: n=133; group B: n=135). SOCA communication skills measures (score range 4-16) from the first face-to-face consultation were significantly higher for students in group A who had completed EQClinic training and reviewed the nonverbal behavior feedback, compared with group B, who had completed

  5. A Web-Based Telehealth Training Platform Incorporating Automated Nonverbal Behavior Feedback for Teaching Communication Skills to Medical Students: A Randomized Crossover Study

    Science.gov (United States)

    2016-01-01

    Background In the interests of patient health outcomes, it is important for medical students to develop clinical communication skills. We previously proposed a telehealth communication skills training platform (EQClinic) with automated nonverbal behavior feedback for medical students, and it was able to improve medical students’ awareness of their nonverbal communication. Objective This study aimed to evaluate the effectiveness of EQClinic to improve clinical communication skills of medical students. Methods We conducted a 2-group randomized crossover trial between February and June 2016. Participants were second-year medical students enrolled in a clinical communication skills course at an Australian university. Students were randomly allocated to complete online EQClinic training during weeks 1–5 (group A) or to complete EQClinic training during weeks 8–11 (group B). EQClinic delivered an automated visual presentation of students’ nonverbal behavior coupled with human feedback from a standardized patient (SP). All students were offered two opportunities to complete face-to-face consultations with SPs. The two face-to-face consultations were conducted in weeks 6–7 and 12–13 for both groups, and were rated by tutors who were blinded to group allocation. Student-Patient Observed Communication Assessment (SOCA) was collected by blinded assessors (n=28) at 2 time points and also by an SP (n=83). Tutor-rated clinical communications skill in face-to-face consultations was the primary outcome and was assessed with the SOCA. We used t tests to examine the students’ performance during face-to-face consultations pre- and postexposure to EQClinic. Results We randomly allocated 268 medical students to the 2 groups (group A: n=133; group B: n=135). SOCA communication skills measures (score range 4–16) from the first face-to-face consultation were significantly higher for students in group A who had completed EQClinic training and reviewed the nonverbal behavior

  6. Efficacy and safety of premedication with single dose of oral pregabalin in children with dental anxiety: A randomized double-blind placebo-controlled crossover clinical trial

    Directory of Open Access Journals (Sweden)

    Tahereh Eskandarian

    2015-01-01

    Full Text Available Background: Dental anxiety is a relatively frequent problem that can lead to more serious problems such as a child entering a vicious cycle as he/she becomes reluctant to accept the required dental treatments. The aim of this randomized double-blind clinical trial study was to evaluate the anxiolytic and sedative effect of pregabalin in children. Materials and Methods: Twenty-five children were randomized to a double-blind placebo-controlled crossover clinical trial. Two visits were scheduled for each patient. At the first visit, 75 mg pregabalin or placebo was given randomly, and the alternative was administered at the next visit. Anxiolytic and sedative effects were measured using the visual analogue scale. The child′s behavior was rated with the Frankl behavioral rating scale and the sedation level during the dental procedure was scored using the Ramsay sedation scale. The unpaired, two-tailed Student′s t-test was used to compare the mean changes of visual analog scale (VAS for anxiety in the pregabalin group with that of the placebo group. A repeated measures MANOVA model was used to detect differences in sedation level in the pregabalin and placebo groups regarding the interaction of 3-time measurements; sub-group analysis was performed using Student′s t-test. The Mann-Whitney U-test was used to analyze the nonparametric data of the Frankl and Ramsay scales. A P < 0.05 was considered significant. Results: The reduction of the VAS-anxiety score from 2 h post-dose was statistically significant in the pregabalin group. From 2 h to 4 h post-dose, the VAS-sedation score increased significantly in the pregabalin group. The child′s behavior rating was not significantly different between the groups. The number of "successful" treatment visits was higher in the pregabalin group compared to the placebo group. Conclusion: Significant anxiolytic and sedative effects can be anticipated 2 h after oral administration of pregabalin without serious

  7. Implications of different application sites on the bioavailability of a transdermal contraceptive patch containing ethinyl estradiol and gestodene: an open-label, randomized, crossover study.

    Science.gov (United States)

    Höchel, Joachim; Schuett, Barbara; Ludwig, Matthias; Zurth, Christian

    2014-10-01

    A novel once-a-week contraceptive patch delivers the same systemic exposure seen with a combined oral contraceptive pill containing 0.02 mg ethinyl estradiol (EE) and 0.06 mg gestodene (GSD). This study evaluated the relative bioavailability of EE and GSD after application of this patch to three different sites. In this phase I, open-label, randomized, intra-individual comparison, crossover study, 43 women (aged 18 - 45 years) were randomized to one of six treatment sequences. Patches were applied to two test sites (buttocks and outer, upper arm) and one comparator site (lower abdomen). In each treatment period, four patches were worn for 7 days each, followed by a 7-day, patch-free interval. The primary objective was to investigate the relative bioavailability of transdermally administered EE and GSD between test and comparator sites using the primary variable area under the concentration- time curve (AUC(0-168)) during week 4 of each period. Of the 43 women who were randomized, 43 were included in the set for safety evaluation and 40 were included in the set for pharmacokinetic (PK) analysis. Three subjects were excluded from the PK analysis as they failed to complete the study. AUC(0-168) for EE and GSD were equal when the patch was applied to buttocks or abdomen (AUC(0-168) ratios: EE, 1.07 (94% confidence interval, CI: 0.994 - 1.16); GSD, 1.02 (94% CI: 0.946 - 1.10)). Relative bioavailabilities for EE and GSD were 31% and 24% higher, respectively, for arm vs. abdomen. AUC(0-168) 94% CI for the arm/abdomen ratio exceeded the pre-defined bioequivalence range of 80 - 125% (EE: 1.21 - 1.42; GSD: 1.15 - 1.34). Other PK parameters were correspondingly higher for arm vs. buttocks or abdomen. Patch adhesion and tolerability were good, with no relevant differences between sites. Differences in systemic EE/GSD exposure following patch application to the outer, upper arm vs. lower abdomen and buttocks are unlikely to be clinically relevant, and there were no relevant

  8. Magnesium supplementation, metabolic and inflammatory markers, and global genomic and proteomic profiling: a randomized, double-blind, controlled, crossover trial in overweight individuals123

    Science.gov (United States)

    Chacko, Sara A; Sul, James; Song, Yiqing; Li, Xinmin; LeBlanc, James; You, Yuko; Butch, Anthony; Liu, Simin

    2011-01-01

    Background: Dietary magnesium intake has been favorably associated with reduced risk of metabolic outcomes in observational studies; however, few randomized trials have introduced a systems-biology approach to explore molecular mechanisms of pleiotropic metabolic actions of magnesium supplementation. Objective: We examined the effects of oral magnesium supplementation on metabolic biomarkers and global genomic and proteomic profiling in overweight individuals. Design: We undertook this randomized, crossover, pilot trial in 14 healthy, overweight volunteers [body mass index (in kg/m2) ≥25] who were randomly assigned to receive magnesium citrate (500 mg elemental Mg/d) or a placebo for 4 wk with a 1-mo washout period. Fasting blood and urine specimens were collected according to standardized protocols. Biochemical assays were conducted on blood specimens. RNA was extracted and subsequently hybridized with the Human Gene ST 1.0 array (Affymetrix, Santa Clara, CA). Urine proteomic profiling was analyzed with the CM10 ProteinChip array (Bio-Rad Laboratories, Hercules, CA). Results: We observed that magnesium treatment significantly decreased fasting C-peptide concentrations (change: −0.4 ng/mL after magnesium treatment compared with +0.05 ng/mL after placebo treatment; P = 0.004) and appeared to decrease fasting insulin concentrations (change: −2.2 μU/mL after magnesium treatment compared with 0.0 μU/mL after placebo treatment; P = 0.25). No consistent patterns were observed across inflammatory biomarkers. Gene expression profiling revealed up-regulation of 24 genes and down-regulation of 36 genes including genes related to metabolic and inflammatory pathways such as C1q and tumor necrosis factor–related protein 9 (C1QTNF9) and pro-platelet basic protein (PPBP). Urine proteomic profiling showed significant differences in the expression amounts of several peptides and proteins after treatment. Conclusion: Magnesium supplementation for 4 wk in overweight

  9. Magnesium supplementation, metabolic and inflammatory markers, and global genomic and proteomic profiling: a randomized, double-blind, controlled, crossover trial in overweight individuals.

    Science.gov (United States)

    Chacko, Sara A; Sul, James; Song, Yiqing; Li, Xinmin; LeBlanc, James; You, Yuko; Butch, Anthony; Liu, Simin

    2011-02-01

    Dietary magnesium intake has been favorably associated with reduced risk of metabolic outcomes in observational studies; however, few randomized trials have introduced a systems-biology approach to explore molecular mechanisms of pleiotropic metabolic actions of magnesium supplementation. We examined the effects of oral magnesium supplementation on metabolic biomarkers and global genomic and proteomic profiling in overweight individuals. We undertook this randomized, crossover, pilot trial in 14 healthy, overweight volunteers [body mass index (in kg/m(2)) ≥25] who were randomly assigned to receive magnesium citrate (500 mg elemental Mg/d) or a placebo for 4 wk with a 1-mo washout period. Fasting blood and urine specimens were collected according to standardized protocols. Biochemical assays were conducted on blood specimens. RNA was extracted and subsequently hybridized with the Human Gene ST 1.0 array (Affymetrix, Santa Clara, CA). Urine proteomic profiling was analyzed with the CM10 ProteinChip array (Bio-Rad Laboratories, Hercules, CA). We observed that magnesium treatment significantly decreased fasting C-peptide concentrations (change: -0.4 ng/mL after magnesium treatment compared with +0.05 ng/mL after placebo treatment; P = 0.004) and appeared to decrease fasting insulin concentrations (change: -2.2 μU/mL after magnesium treatment compared with 0.0 μU/mL after placebo treatment; P = 0.25). No consistent patterns were observed across inflammatory biomarkers. Gene expression profiling revealed up-regulation of 24 genes and down-regulation of 36 genes including genes related to metabolic and inflammatory pathways such as C1q and tumor necrosis factor-related protein 9 (C1QTNF9) and pro-platelet basic protein (PPBP). Urine proteomic profiling showed significant differences in the expression amounts of several peptides and proteins after treatment. Magnesium supplementation for 4 wk in overweight individuals led to distinct changes in gene expression and

  10. Upper airway stabilization by osteopathic manipulation of the sphenopalatine ganglion versus sham manipulation in OSAS patients: a proof-of-concept, randomized, crossover, double-blind, controlled study.

    Science.gov (United States)

    Jacq, Olivier; Arnulf, Isabelle; Similowski, Thomas; Attali, Valérie

    2017-12-20

    Osteopathic manipulative treatment (OMT) of the sphenopalatine ganglion (SPG) is used empirically for the treatment of rhinitis and snoring and is thought to increase pharyngeal stability. This trial was designed to study the effects of this treatment on pharyngeal stability evaluated by critical closing pressure in obstructive sleep apnoea syndrome. This single-centre, randomized, crossover, double-blind study compared active manipulation and sham manipulation of the SPG. Randomization was computer-generated. Patients each received one active manipulation and one sham manipulation at an interval of 21 days and were evaluated 30 min and 48 h after each session administered by a qualified osteopath. Neither the patients, nor the investigator performing the evaluations were informed about the order of the two techniques (double-blind). The primary endpoint was the percentage of responding patients presenting increased pharyngeal stability defined by a variation of critical closing pressure (Pcrit) of at least -4 cmH 2 O at 30 min. Secondary endpoints were the variation of Pcrit in absolute values, sleepiness and snoring. Others endpoints were lacrimation (Schirmer's test), induced pain, sensations experienced during OMT. Ten patients were included and nine (57 [50; 58] years, comprising 7 men, with an apnoea-hypopnoea index of 31.0 [25.5; 33.2]/h; (values are median [quartiles])) were analysed. Seven patients were analysed for the primary endpoint and nine patients were analysed for secondary endpoints. Five patients responded after active manipulation versus no patients after sham manipulation (p = 0.0209). Active manipulation induced more intense pain (p = 0.0089), increased lacrimation (ns) and more tactile, nociceptive and gustatory sensations (13 versus 1) compared to sham manipulation. No significant difference was observed for the other endpoints. Osteopathic manipulative treatment of the SPG may improve pharyngeal stability in obstructive sleep

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

    Directory of Open Access Journals (Sweden)

    Gudlaugsson Janus

    2012-09-01

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

  12. The biphasic effects of moderate alcohol consumption with a meal on ambiance-induced mood and autonomic nervous system balance: a randomized crossover trial.

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    Ilse C Schrieks

    Full Text Available BACKGROUND: The pre-drinking mood state has been indicated to be an important factor in the mood effects of alcohol. However, for moderate alcohol consumption there are no controlled studies showing this association. Also, the mood effects of consuming alcohol combined with food are largely unknown. The aim of this study was to investigate the effects of moderate alcohol combined with a meal on ambiance-induced mood states. Furthermore effects on autonomic nervous system activity were measured to explore physiological mechanisms that may be involved in changes of mood state. METHODS: In a crossover design 28 women (age 18-45 y, BMI 18.5-27 kg/m2 were randomly allocated to 4 conditions in which they received 3 glasses of sparkling white wine (30 g alcohol or alcohol-free sparkling white wine while having dinner in a room with either a pleasant or unpleasant created ambiance. Subjects filled out questionnaires (B-BAES, POMS and postprandial wellness questionnaire at different times. Skin conductance and heart rate variability were measured continuously. RESULTS: Moderate alcohol consumption increased happiness scores in the unpleasant, but not in the pleasant ambiance. Alcohol consumption increased happiness and stimulation feelings within 1 hour and increased sedative feelings and sleepiness for 2.5 hour. Skin conductance was increased after alcohol within 1 hour and was related to happiness and stimulation scores. Heart rate variability was decreased after alcohol for 2 hours and was related to mental alertness. CONCLUSION: Mood inductions and autonomic nervous system parameters may be useful to evaluate mood changes by nutritional interventions. Moderate alcohol consumption elevates happiness scores in an unpleasant ambiance. However, drinking alcohol during a pleasant mood results in an equally positive mood state. TRIAL REGISTRATION: Clinicaltrials.gov NCT01426022.

  13. The biphasic effects of moderate alcohol consumption with a meal on ambiance-induced mood and autonomic nervous system balance: a randomized crossover trial.

    Science.gov (United States)

    Schrieks, Ilse C; Stafleu, Annette; Kallen, Victor L; Grootjen, Marc; Witkamp, Renger F; Hendriks, Henk F J

    2014-01-01

    The pre-drinking mood state has been indicated to be an important factor in the mood effects of alcohol. However, for moderate alcohol consumption there are no controlled studies showing this association. Also, the mood effects of consuming alcohol combined with food are largely unknown. The aim of this study was to investigate the effects of moderate alcohol combined with a meal on ambiance-induced mood states. Furthermore effects on autonomic nervous system activity were measured to explore physiological mechanisms that may be involved in changes of mood state. In a crossover design 28 women (age 18-45 y, BMI 18.5-27 kg/m2) were randomly allocated to 4 conditions in which they received 3 glasses of sparkling white wine (30 g alcohol) or alcohol-free sparkling white wine while having dinner in a room with either a pleasant or unpleasant created ambiance. Subjects filled out questionnaires (B-BAES, POMS and postprandial wellness questionnaire) at different times. Skin conductance and heart rate variability were measured continuously. Moderate alcohol consumption increased happiness scores in the unpleasant, but not in the pleasant ambiance. Alcohol consumption increased happiness and stimulation feelings within 1 hour and increased sedative feelings and sleepiness for 2.5 hour. Skin conductance was increased after alcohol within 1 hour and was related to happiness and stimulation scores. Heart rate variability was decreased after alcohol for 2 hours and was related to mental alertness. Mood inductions and autonomic nervous system parameters may be useful to evaluate mood changes by nutritional interventions. Moderate alcohol consumption elevates happiness scores in an unpleasant ambiance. However, drinking alcohol during a pleasant mood results in an equally positive mood state. Clinicaltrials.gov NCT01426022.

  14. Hemostatic effects of a novel estradiol-based oral contraceptive: an open-label, randomized, crossover study of estradiol valerate/dienogest versus ethinylestradiol/levonorgestrel.

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    Klipping, Christine; Duijkers, Ingrid; Parke, Susanne; Mellinger, Uwe; Serrani, Marco; Junge, Wolfgang

    2011-01-01

    A novel estradiol-based combined oral contraceptive (COC) is currently available in many countries worldwide, including Europe and the US. Based on previous studies, it is expected that this estradiol-based COC will have a reduced hepatic effect compared with COCs containing ethinylestradiol with regard to proteins controlling the hemostatic balance. The aim of this study was to compare the hemostatic effects of the estradiol valerate/dienogest COC with a monophasic low-estrogen dose COC containing ethinylestradiol/levonorgestrel. Healthy women aged 18-50 years were randomized to receive a COC containing estradiol valerate/dienogest (2 days estradiol valerate 3 mg, 5 days estradiol valerate 2 mg/dienogest 2 mg, 17 days estradiol valerate 2 mg/dienogest 3 mg, 2 days estradiol valerate 1 mg, 2 days placebo) or ethinylestradiol 0.03 mg/levonorgestrel 0.15 mg in a crossover study design. Women received each treatment for three cycles, with two washout cycles between treatments. The primary efficacy variables were the intra-individual absolute changes in prothrombin fragment 1 + 2 and D-dimer from baseline to cycle three. Data from 29 women were assessed. Intra-individual absolute changes in prothrombin fragment 1 + 2 and D-dimer from baseline to cycle three were less pronounced with estradiol valerate/dienogest than with ethinylestradiol/levonorgestrel. The novel COC containing estradiol valerate/dienogest had similar or less pronounced effects on hemostatic parameters than ethinylestradiol/levonorgestrel.

  15. Unexpected Inflammatory Effects of Intravaginal Gels (Universal Placebo Gel and Nonoxynol-9 on the Upper Female Reproductive Tract: A Randomized Crossover Study.

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    Karen Smith-McCune

    Full Text Available Intravaginal anti-HIV microbicides could provide women with a self-controlled means for HIV prevention, but results from clinical trials have been largely disappointing. We postulated that unrecognized effects of intravaginal gels on the upper female reproductive tract might contribute to the lower-than-expected efficacy of HIV microbicides. Our objective was to study the effects of intravaginal gels on the immune microenvironment of the cervix and uterus. In this randomized crossover study, 27 healthy female volunteers used a nightly application of intravaginal nonoxynol-9 (N9 gel as a "failed" microbicide or the universal placebo gel (UPG as a "safe" gel (intervention cycles, or nothing (control cycle from the end of menses to the mid-luteal phase. At a specific time-point following ovulation, all participants underwent sample collection for measurements of T-cell phenotypes, gene expression, and cytokine/chemokine protein concentrations from 3 anatomic sites above the vagina: the cervical transformation zone, the endocervix and the endometrium. We used hierarchical statistical models to estimate mean (95% CI intervention effects, for N9 and UPG relative to control. Exposure to N9 gel and UPG generated a common "harm signal" that included transcriptional up-regulation of inflammatory genes chemokine (C-C motif ligand 20 (macrophage inflammatory factor-3alpha and interleukin 8 in the cervix, decreased protein concentrations of secretory leukocyte protease inhibitor, and transcriptional up-regulation of inflammatory mediators glycodelin-A and osteopontin in the endometrium. These results need to be replicated with a larger sample, but underscore the need to consider the effects of microbicide agents and gel excipients on the upper female reproductive tract in studies of vaginal microbicides.

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

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

    2012-05-01

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

  17. Postprandial lipid responses to an alpha-linolenic acid-rich oil, olive oil and butter in women: A randomized crossover trial

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    Rosenquist Anna

    2011-06-01

    Full Text Available Abstract Background Postprandial lipaemia varies with gender and the composition of dietary fat due to the partitioning of fatty acids between beta-oxidation and incorporation into triacylglycerols (TAGs. Increasing evidence highlights the importance of postprandial measurements to evaluate atherogenic risk. Postprandial effects of alpha-linolenic acid (ALA in women are poorly characterized. We therefore studied the postprandial lipid response of women to an ALA-rich oil in comparison with olive oil and butter, and characterized the fatty acid composition of total lipids, TAGs, and non-esterified fatty acids (NEFAs in plasma. Methods A randomized crossover design (n = 19 was used to compare the postprandial effects of 3 meals containing 35 g fat. Blood samples were collected at regular intervals for 7 h. Statistical analysis was carried out with ANOVA (significant difference = P Results No significant difference was seen in incremental area under the curve (iAUC plasma-TAG between the meals. ALA and oleic acid levels were significantly increased in plasma after ALA-rich oil and olive oil meals, respectively. Palmitic acid was significantly increased in plasma-TAG after the butter meal. The ratios of 18:2 n-6 to18:3 n-3 in plasma-TAGs, three and seven hours after the ALA-rich oil meal, were 1.5 and 2.4, respectively. The corresponding values after the olive oil meal were: 13.8 and 16.9; and after the butter meal: 9.0 and 11.6. Conclusions The postprandial p-TAG and NEFA response in healthy pre-menopausal women was not significantly different after the intake of an ALA-rich oil, olive oil and butter. The ALA-rich oil significantly affected different plasma lipid fractions and improved the ratio of n-6 to n-3 fatty acids several hours postprandially.

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

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    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.

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

    Science.gov (United States)

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

    2015-01-01

    Background: Postmenopausal estrogen depletion is a major contributing factor to bone loss. Soy isoflavones have variable effects on the prevention of postmenopausal bone loss, which is possibly related to the specific isoflavone content or the variable equol-producing capacity of individuals. Objective: We aimed to determine the effects of the content of isoflavones in a soy supplement and the equol-producing ability of the individual on postmenopausal bone calcium retention. Design: The study was a blinded, randomized, crossover intervention trial in 24 postmenopausal women who were prescreened for their ability to convert daidzein to equol. Women were equilibrated with 41Ca before the intervention. Interventions were 5 soy isoflavone oral supplements (2 doses of a genistein-rich soy supplement and 3 doses of mixed isoflavones in various proportions) and a bisphosphonate (risedronate). Each intervention was given sequentially for 50 d followed by a 50-d washout period. The percentage of bone calcium retention was determined from the change in urinary 41Ca:calcium. Results: Interventions that ranged from 52 to 220 mg total isoflavones/d increased bone calcium retention between 3.4% and 7.6% (P soy intervention delivered 105.23 mg total isoflavones/d as genistein, daidzein, and glycitein in their natural ratios and increased bone calcium retention by 7.6% (95% CI: 4.9%, 10.2%; P Soy isoflavones, although not as potent as risedronate, are effective bone-preserving agents in postmenopausal women regardless of their equol-producing status, and mixed isoflavones in their natural ratios are more effective than enriched genistein. This trial was registered at clinicaltrials.gov as NCT00244907. PMID:26245807

  20. Acute Effects of Nitrate-Rich Beetroot Juice on Blood Pressure, Hemostasis and Vascular Inflammation Markers in Healthy Older Adults: A Randomized, Placebo-Controlled Crossover Study

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    Kyle Raubenheimer

    2017-11-01

    Full Text Available Aging is associated with a vasoconstrictive, pro-coagulant, and pro-inflammatory profile of arteries and a decline in the bioavailability of the endothelium-derived molecule nitric oxide. Dietary nitrate elicits vasodilatory, anti-coagulant and anti-inflammatory effects in younger individuals, but little is known about whether these benefits are evident in older adults. We investigated the effects of 140 mL of nitrate-rich (HI-NI; containing 12.9 mmol nitrate versus nitrate-depleted beetroot juice (LO-NI; containing ≤0.04 mmol nitrate on blood pressure, blood coagulation, vascular inflammation markers, plasma nitrate and nitrite before, and 3 h and 6 h after ingestion in healthy older adults (five males, seven females, mean age: 64 years, age range: 57–71 years in a randomized, placebo-controlled, crossover study. Plasma nitrate and nitrite increased 3 and 6 h after HI-NI ingestion (p < 0.05. Systolic, diastolic and mean arterial blood pressure decreased 3 h relative to baseline after HI-NI ingestion only (p < 0.05. The number of blood monocyte-platelet aggregates decreased 3 h after HI-NI intake (p < 0.05, indicating reduced platelet activation. The number of blood CD11b-expressing granulocytes decreased 3 h following HI-NI beetroot juice intake (p < 0.05, suggesting a shift toward an anti-adhesive granulocyte phenotype. Numbers of blood CD14++CD16+ intermediate monocyte subtypes slightly increased 6 h after HI-NI beetroot juice ingestion (p < 0.05, but the clinical implications of this response are currently unclear. These findings provide new evidence for the acute effects of nitrate-rich beetroot juice on circulating immune cells and platelets. Further long-term research is warranted to determine if these effects reduce the risk of developing hypertension and vascular inflammation with aging.

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

    Science.gov (United States)

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

    2013-01-01

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

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

    Science.gov (United States)

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

    2015-01-01

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

  3. 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

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    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.

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

    Science.gov (United States)

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

    2013-07-01

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

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

    Science.gov (United States)

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

    2016-03-01

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

  6. Comparison between Steroid Injection and Stretching Exercise on the Scalene of Patients with Upper Extremity Paresthesia: Randomized Cross-Over Study.

    Science.gov (United States)

    Kim, Yong Wook; Yoon, Seo Yeon; Park, Yongbum; Chang, Won Hyuk; Lee, Sang Chul

    2016-03-01

    To compare the therapeutic effects on upper extremity paresthesia of intra-muscular steroid injections into the scalene muscle with those of stretching exercise only. Twenty patients with upper extremity paresthesia who met the criteria were recruited to participate in this single-blind, crossover study. Fourteen of 20 patients were female. The average age was 45.0 ± 10.5 years and duration of symptom was 12.2 ± 8.7 months. Each participant completed one injection and daily exercise program for 2 weeks. After randomization, half of all patients received ultrasound-guided injection of scalene muscles before exercise, while the other was invested for the other patients. After two weeks, there was a significant decrease of the visual analog scale score of treatment effect compared with baseline in both groups (6.90 to 2.85 after injection and 5.65 to 4.05 after stretching exercise, pstretching exercise (p50% reduction in post-treatment visual analog scale, was 18 of 20 (90.0%) after injection, compared to 5 of 20 (25.0%) after stretching exercise. There were no cases of unintended brachial plexus block after injection. Ultrasound-guided steroid injection or stretching exercise of scalene muscles led to reduced upper extremity paresthesia in patients who present with localized tenderness in the scalene muscle without electrodiagnostic test abnormalities, although injection treatment resulted in more improvements. The results suggest that symptoms relief might result from injection into the muscle alone not related to blockade of the brachial plexus.

  7. 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.

    Science.gov (United States)

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

    2013-06-20

    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. 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, Lactobacillus acidophilus La5, Lactobacillus casei CRL431) and 4 g inulin for two 15-day treatment periods, each preceded by a 6-week washout period. GI transit time (GTT), duration of colour (DOC), GI symptoms and dietary intake were assessed and analyzed using repeated measures ANOVA, including PRE-treatment GTT as a covariate. Participants were grouped as short GTT (STT, n = 50, ≤32.7 h) or long GTT (LTT, n = 15, >32.7 h) based on their PRE-treatment GTT assessment. POST-treatment GTT and DOC were not different between synbiotic and control, and did not change from PRE-treatment, within the STT or LTT groups. There were no changes in GI symptom ratings, indicating that both yogurts were well tolerated. In STT, energy, fat and protein intakes were decreased from baseline with synbiotic (p = 0.055, p = 0.059 and p = 0.005, respectively) and dietary fibre intake was higher POST-treatment with synbiotic versus control (p = 0.0002). In LTT, decreases in energy and fat intakes with synbiotic were not significant (p = 0.14 and p = 0.18, respectively) and there were no differences in dietary fibre intake. Consuming 200 g/day of synbiotic yogurt did not significantly alter GTT in healthy adults, but was well tolerated and helped to reduce overall energy intake.

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

    Science.gov (United States)

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

    2010-11-01

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

  9. Intake and time dependence of blueberry flavonoid-induced improvements in vascular function: a randomized, controlled, double-blind, crossover intervention study with mechanistic insights into biological activity.

    Science.gov (United States)

    Rodriguez-Mateos, Ana; Rendeiro, Catarina; Bergillos-Meca, Triana; Tabatabaee, Setareh; George, Trevor W; Heiss, Christian; Spencer, Jeremy Pe

    2013-11-01

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

  10. A randomized, double-blind, crossover comparison of novel continuous bed motion versus traditional bed position whole-body PET/CT imaging

    International Nuclear Information System (INIS)

    Schatka, Imke; Weiberg, Desiree; Reichelt, Stephanie; Owsianski-Hille, Nicole; Derlin, Thorsten; Berding, Georg; Bengel, Frank M.

    2016-01-01

    Continuous bed motion has recently been introduced for whole-body PET/CT, and represents a paradigm shift towards individualized and flexible acquisition without the limitations of bed position-based planning. Increased patient comfort due to lack of abrupt table position changes may be another albeit still unproven advantage. For robust clinical implementation, image quality and quantitative accuracy should at least be equal to the prior standard of bed position-based step-and-shoot imaging. The study included 68 consecutive patients referred for whole-body PET/CT for various malignancies. The patients underwent traditional step-and-shoot and novel continuous bed motion acquisition in the same session in a randomized crossover design. The patients and two independent observers were blinded to the sequence of scan techniques. Patient comfort/satisfaction was examined using a standardized questionnaire. SUVs were compared for reference tissue (liver, muscle) and tumour lesions. PET image quality and misalignment with CT images were evaluated on a scale of 1 - 4. Patients preferred continuous bed motion over step-and-shoot (P = 0.0001). It was considered to be more relaxing (38 % vs. 8 %), quieter (34 % vs. 8 %), and more fluid (64 % vs. 8 %). Image quality, SUV and CT misalignment did not differ between the techniques. Continuous bed motion resulted in better end-plane image quality (P < 0.0001). Regardless of the technique, second examinations had significantly higher tumour lesion SUVmax values (P = 0.0002), and a higher CT misalignment score (P = 0.0017). Oncological PET/CT with continuous bed motion enhances patient comfort and is associated with image quality at least comparable to that with traditional bed position-based step-and-shoot acquisition. (orig.)

  11. Color-coded prefilled medication syringes decrease time to delivery and dosing errors in simulated prehospital pediatric resuscitations: A randomized crossover trial.

    Science.gov (United States)

    Stevens, Allen D; Hernandez, Caleb; Jones, Seth; Moreira, Maria E; Blumen, Jason R; Hopkins, Emily; Sande, Margaret; Bakes, Katherine; Haukoos, Jason S

    2015-11-01

    Medication dosing errors remain commonplace and may result in potentially life-threatening outcomes, particularly for pediatric patients where dosing often requires weight-based calculations. Novel medication delivery systems that may reduce dosing errors resonate with national healthcare priorities. Our goal was to evaluate novel, prefilled medication syringes labeled with color-coded volumes corresponding to the weight-based dosing of the Broselow Tape, compared to conventional medication administration, in simulated prehospital pediatric resuscitation scenarios. We performed a prospective, block-randomized, cross-over study, where 10 full-time paramedics each managed two simulated pediatric arrests in situ using either prefilled, color-coded syringes (intervention) or their own medication kits stocked with conventional ampoules (control). Each paramedic was paired with two emergency medical technicians to provide ventilations and compressions as directed. The ambulance patient compartment and the intravenous medication port were video recorded. Data were extracted from video review by blinded, independent reviewers. Median time to delivery of all doses for the intervention and control groups was 34 (95% CI: 28-39) seconds and 42 (95% CI: 36-51) seconds, respectively (difference=9 [95% CI: 4-14] seconds). Using the conventional method, 62 doses were administered with 24 (39%) critical dosing errors; using the prefilled, color-coded syringe method, 59 doses were administered with 0 (0%) critical dosing errors (difference=39%, 95% CI: 13-61%). A novel color-coded, prefilled syringe decreased time to medication administration and significantly reduced critical dosing errors by paramedics during simulated prehospital pediatric resuscitations. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  12. Hesperidin displays relevant role in the nutrigenomic effect of orange juice on blood leukocytes in human volunteers: a randomized controlled cross-over study.

    Directory of Open Access Journals (Sweden)

    Dragan Milenkovic

    Full Text Available We previously showed, in healthy, middle-aged, moderately overweight men, that orange juice decreases diastolic blood pressure and significantly improves postprandial microvascular endothelial reactivity and that hesperidin could be causally linked to the observed beneficial effect of orange juice. The objective was to determine the effect of chronic consumption of orange juice on the gene expression profile of leukocytes in healthy volunteers and to assess to what extent hesperidin is involved in the effect of orange juice.Volunteers were included in a randomized, controlled, crossover study. Throughout three 4-week periods, volunteers consumed daily: 500 ml orange juice, 500 ml control drink plus hesperidin or 500 ml control drink and placebo. Blood samplings were performed on 10 overnight-fasted subjects after the 4-week treatment period. Global gene expression profiles were determined using human whole genome cDNA microarrays. Both orange juice and hesperidin consumption significantly affected leukocyte gene expression. Orange juice consumption induced changes in expression of, 3,422 genes, while hesperidin intake modulated the expression of 1,819 genes. Between the orange juice and hesperidin consumption groups, 1,582 regulated genes were in common. Many of these genes are implicated in chemotaxis, adhesion, infiltration and lipid transport, which is suggestive of lower recruitment and infiltration of circulating cells to vascular wall and lower lipid accumulation.This study shows that regular consumption of orange juice for 4 weeks alters leukocyte gene expression to an anti-inflammatory and anti-atherogenic profile, and hesperidin displays a relevant role in the genomic effect of this beverage.ClinicalTrials.gov NCT 00983086.

  13. Marked antioxidant effect of orange juice intake and its phytomicronutrients in a preliminary randomized cross-over trial on mild hypercholesterolemic men.

    Science.gov (United States)

    Constans, Joël; Bennetau-Pelissero, Catherine; Martin, Jean-François; Rock, Edmond; Mazur, Andrzej; Bedel, Aurélie; Morand, Christine; Bérard, Annie M

    2015-12-01

    Blond orange juice is the most consumed fruit juice in the world. It is a source of hesperidin, a bioavailable flavonoid reported to exhibit potential vascular protective actions. However, the specific impact on vascular function of Citrus phytomicronutrients, is unknown. For the first time, we investigated the effects of blond orange juice compared with a control beverage mimicking the composition of orange juice (including Vitamin C but no phytomicronutrients), on antioxidant markers, cardiovascular risk factors and endothelial function. Twenty five male volunteers with two cardiovascular risk factors (age over 50 years and LDL-cholesterol between 130 and 190 mg/L) were enrolled in a randomized cross-over study. They received 3 times daily 200 mL of either blond orange juice or control beverage for 4 weeks, spaced by a 5-week wash-out. Endothelial function (flow mediated dilatation and plasma markers), oxidative status, lipid profile and inflammatory markers were assessed. Daily intakes of orange juice significantly led to a marked antioxidant effect which was correlated to hesperetin plasma levels and related with a decrease in reactive oxygen species. A tendency towards reduction of endothelial dysfunction and modest increase in plasma apoA-I concentration were also observed. This allows further experiments demonstrating the specific effect of phytomicronutrients from orange juice. These findings suggest that daily intake of nutritionally relevant dose of blond orange juice may contribute for a significant antioxidant effect through the phytochemicals contained in. Orange juice may be associated to other healthy foods to achieve a significant effect on the vascular function. This study is recorded in ClinicalTrials.com as NCT00539916. Copyright © 2014. Published by Elsevier Ltd.

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

    International Nuclear Information System (INIS)

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

    1985-01-01

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

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Science.gov (United States)

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

    2016-11-01

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

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

    Science.gov (United States)

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

    2015-09-01

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

  18. Myofascial Induction Effects on Neck-Shoulder Pain in Breast Cancer Survivors: Randomized, Single-Blind, Placebo-Controlled Crossover Design.

    Science.gov (United States)

    Castro-Martín, Eduardo; Ortiz-Comino, Lucía; Gallart-Aragón, Tania; Esteban-Moreno, Bernabé; Arroyo-Morales, Manuel; Galiano-Castillo, Noelia

    2017-05-01

    To (1) investigate the immediate effects of myofascial induction (MI), with placebo electrotherapy as a control, on perceived pain, cervical/shoulder range of motion (ROM), and mood state in breast cancer survivors (BCSs) with shoulder/arm morbidity; and (2) examine the relationships between pain modifications and cervical/shoulder ROM on the side affected by breast cancer. Randomized, single-blind, placebo-controlled crossover study. Physical therapy laboratory. BCSs (N=21) who had a diagnosis of stage I-IIIA breast cancer and had completed adjuvant therapy (except hormonal treatment). During each session, the BCSs received either an MI (fascial unwinding) intervention focused on the upper limb area following the Pilat approach or placebo pulsed shortwave therapy (control group). Each session lasted 30 minutes, and an adequate washout period of 4 weeks between sessions was established. The visual analog scale (VAS) for pain and anxiety, shoulder-cervical goniometry for ROM, the Profile of Mood States for psychological distress, and the Attitudes Towards Massage Scale were used. An analysis of covariance (ANCOVA) revealed significant time × group interactions for VAS affected arm (P=.031) but not for VAS cervical (P=.332), VAS nonaffected arm (P=.698), or VAS anxiety (P=.266). The ANCOVA also revealed significant interactions for affected shoulder flexion (P<.001), abduction (P<.001), external rotation (P=.004), and internal rotation (P=.001). Significant interactions for affected cervical rotation (P=.022) and affected cervical lateral flexion (P=.038) were also found. A significant negative correlation was found between changes in VAS affected arm and shoulder/arm internal rotation ROM (r=-.46; P=.03). A single MI session decreases pain intensity and improves neck-shoulder ROM to a greater degree than placebo electrotherapy for BCSs experiencing pain. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  19. Airtraq Laryngoscope Versus the Conventional Macintosh Laryngoscope During Pediatric Intubation Performed by Nurses: A Randomized Crossover Manikin Study With Three Airway Scenarios.

    Science.gov (United States)

    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.

  20. A fish-based diet intervention improves endothelial function in postmenopausal women with type 2 diabetes mellitus: a randomized crossover trial.

    Science.gov (United States)

    Kondo, Keiko; Morino, Katsutaro; Nishio, Yoshihiko; Kondo, Motoyuki; Nakao, Keiko; Nakagawa, Fumiyuki; Ishikado, Atsushi; Sekine, Osamu; Yoshizaki, Takeshi; Kashiwagi, Atsunori; Ugi, Satoshi; Maegawa, Hiroshi

    2014-07-01

    The beneficial effects of fish and n-3 polyunsaturated fatty acids (PUFAs) consumption on atherosclerosis have been reported in numerous epidemiological studies. However, to the best of our knowledge, the effects of a fish-based diet intervention on endothelial function have not been investigated. Therefore, we studied these effects in postmenopausal women with type 2 diabetes mellitus (T2DM). Twenty-three postmenopausal women with T2DM were assigned to two four-week periods of either a fish-based diet (n-3 PUFAs ≧ 3.0 g/day) or a control diet in a randomized crossover design. Endothelial function was measured with reactive hyperemia using strain-gauge plethysmography and compared with the serum levels of fatty acids and their metabolites. Endothelial function was determined with peak forearm blood flow (Peak), duration of reactive hyperemia (Duration) and flow debt repayment (FDR). A fish-based dietary intervention improved Peak by 63.7%, Duration by 27.9% and FDR by 70.7%, compared to the control diet. Serum n-3 PUFA levels increased after the fish-based diet period and decreased after the control diet, compared with the baseline (1.49 vs. 0.97 vs. 1.19 mmol/l, p diet intervention, possibly due to the inhibition of the activity of soluble epoxide hydrolase. A fish-based dietary intervention improves endothelial function in postmenopausal women with T2DM. Dissociation between the serum n-3 PUFA concentration and endothelial function suggests that the other factors may contribute to this phenomenon. Copyright © 2014 Elsevier Inc. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Taku Miyagawa

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

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

    Directory of Open Access Journals (Sweden)

    Ann Bjørnshave

    2018-01-01

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

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

    Science.gov (United States)

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

    2016-07-01

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

  4. The Biphasic Effects of Moderate Alcohol Consumption with a Meal on Ambiance-Induced Mood and Autonomic Nervous System Balance: A Randomized Crossover Trial

    Science.gov (United States)

    Schrieks, Ilse C.; Stafleu, Annette; Kallen, Victor L.; Grootjen, Marc; Witkamp, Renger F.; Hendriks, Henk F. J.

    2014-01-01

    Background The pre-drinking mood state has been indicated to be an important factor in the mood effects of alcohol. However, for moderate alcohol consumption there are no controlled studies showing this association. Also, the mood effects of consuming alcohol combined with food are largely unknown. The aim of this study was to investigate the effects of moderate alcohol combined with a meal on ambiance-induced mood states. Furthermore effects on autonomic nervous system activity were measured to explore physiological mechanisms that may be involved in changes of mood state. Methods In a crossover design 28 women (age 18–45 y, BMI 18.5–27 kg/m2) were randomly allocated to 4 conditions in which they received 3 glasses of sparkling white wine (30 g alcohol) or alcohol-free sparkling white wine while having dinner in a room with either a pleasant or unpleasant created ambiance. Subjects filled out questionnaires (B-BAES, POMS and postprandial wellness questionnaire) at different times. Skin conductance and heart rate variability were measured continuously. Results Moderate alcohol consumption increased happiness scores in the unpleasant, but not in the pleasant ambiance. Alcohol consumption increased happiness and stimulation feelings within 1 hour and increased sedative feelings and sleepiness for 2.5 hour. Skin conductance was increased after alcohol within 1 hour and was related to happiness and stimulation scores. Heart rate variability was decreased after alcohol for 2 hours and was related to mental alertness. Conclusion Mood inductions and autonomic nervous system parameters may be useful to evaluate mood changes by nutritional interventions. Moderate alcohol consumption elevates happiness scores in an unpleasant ambiance. However, drinking alcohol during a pleasant mood results in an equally positive mood state. Trial Registration Clinicaltrials.gov NCT01426022. PMID:24465955

  5. A randomized, double-blinded crossover trial testing the benefit of two hydrolysed poultry-based commercial diets for dogs with spontaneous pruritic chicken allergy.

    Science.gov (United States)

    Bizikova, Petra; Olivry, Thierry

    2016-08-01

    Hydrolysed protein diets are used to diagnose and treat dogs with cutaneous adverse food reactions (CAFR). Little is known about what proportion of dogs hypersensitive to the native protein would react to its hydrolysed form. To determine the clinical allergenicity of hydrolysed poultry feather (RCU) and chicken liver diets (HZD) in dogs with chicken induced CAFR. In this randomized, double-blinded, crossover trial, ten dogs with chicken induced CAFR were selected after a positive oral challenge to chicken meat and a negative one to corn. Test diets were fed for 14 days separated by a 14 day wash-out period. Owners rated pruritus daily with a Visual Analog Scale (PVAS). The challenge was ended if a flare in pruritus occurred (i.e. PVAS ≥5/10). The median PVAS scores before feeding RCU and HZD were 0.9 and 1.7, respectively (Wilcoxon signed rank test, P = 0.46). Pruritus scores increased significantly after feeding HZD (Friedman's test, P dogs fed RCU, but four dogs fed HZD (40%), were withdrawn after a flare in pruritus developed (Fisher's test, P = 0.04). The maximal PVAS score was significantly higher after HZD (median: 4.7) compared to RCU (2.5) (Wilcoxon signed rank test, P = 0.01). One dog in each group was withdrawn due to diarrhoea. The hydrolysed poultry feather diet did not induce pruritus flares in dogs allergic to chicken in contrast to the hydrolysed chicken liver diet that led to pruritus flares in 40% of these dogs. © 2016 ESVD and ACVD.

  6. Pharmacokinetics of Active Components of Yokukansan, a Traditional Japanese Herbal Medicine after a Single Oral Administration to Healthy Japanese Volunteers: A Cross-Over, Randomized Study.

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    Hiroyuki Kitagawa

    Full Text Available Yokukansan (YKS is a traditional Japanese herbal medicine called kampo medicine in Japan. Its extract comprises seven crude drugs: Atractylodis lanceae rhizoma, Poria, Cnidii rhizoma, Uncariae uncis cum ramulus, Angelicae radix, Bupleuri radix, and Glycyrrhizae radix. YKS is used to treat neurosis, insomnia, as well as behavioral and psychological symptoms of dementia.To confirm the exposure and pharmacokinetics of the active components of YKS in healthy volunteers.A randomized, open-label, 3-arm, 3-period, crossover trial was conducted on 21 healthy Japanese volunteers at the Kochi Medical University between May 2012 and November 2012.Single oral administration of YKS (2.5 g, 5.0 g, or 7.5 g/day during each period.Plasma concentrations of three active compounds in YKS, namely 18β-glycyrrhetinic acid (GA, geissoschizine methyl ether (GM, and hirsuteine (HTE.The mean maximum plasma concentrations (Cmax of GM and HTE increased dose-dependently (ranges: 0.650-1.98 ng/mL and 0.138-0.450 ng/mL, respectively. The times to maximum plasma concentration after drug administration (tmax were 0.500 h for GM and 0.975-1.00 h for HTE. The apparent elimination half-lives (t1/2 were 1.72-1.95 h for GM and 2.47-3.03 h for HTE. These data indicate the rapid absorption and elimination of GM and HTE. On the other hand, the Cmax, tmax, and t1/2 of GA were 57.7-108 ng/mL, 8.00-8.01 h, and 9.39-12.3 h, respectively.We demonstrated that pharmacologically active components of YKS are detected in humans. Further, we determined the pharmacokinetics of GM, HTE, and GA. This information will be useful to elucidate the pharmacological effects of YKS.Japan Pharmaceutical Information Center JAPIC CTI-121811.

  7. Assessing the contact-activation of coagulation during hemodialysis with three different polysulfone filters: A prospective randomized cross-over trial.

    Science.gov (United States)

    Salvadè, Igor; Del Giorno, Rosaria; Gaetano, Donato; Gabutti, Luca

    2017-07-01

    During hemodialysis (HD) the interaction of the blood with the dialyzer triggers both an inflammatory reaction and an activation of the coagulation cascade. An accepted parameter to quantify the extent of coagulation activation during HD is not available. This study aims to evaluate its amplitude, comparing dialyzers made of different polysulfone polymers, by measuring D-dimers in the filter-rinsing fluids (Frf) and to test whether Frf D-dimers are suitable candidate markers to assess contact coagulation activation during HD. In a prospective, cross-over study 41 hemodialysis patients were randomly allocated to nine HD sessions with three types of polysulfone membranes: Filter A: Poliflux®RevaclearMAX; Filter B: Helixone®Fx80, Filter C: Polyflux®H210. A total of 117 HD sessions were studied. The mean (SD) filter (Frf) D-dimers were 0.19 µg/L (0.56) for Filter A; 0.66 µg/L (2.81) for Filter B; 0.33 µg/L (1.13) for Filter C. Significant differences were found: A vs. B (P filter levels was found. D-Dimers in blood showed a similar trend but differences were not significant. The contact activation of coagulation during HD may also vary among filters made up with similar polysulfones. D-dimer in the filter rinsing fluid but not in the blood can be considered a candidate marker for the evaluation of thrombogenicity during HD. Further studies are needed to elucidate the mechanism(s) and to confirm the usefulness of filter rinsing fluid D-Dimers as a clotting activation marker during HD. © 2016 International Society for Hemodialysis.

  8. Effects of an alveolar recruitment maneuver on subdural pressure, brain swelling, and mean arterial pressure in patients undergoing supratentorial tumour resection: a randomized crossover study.

    Science.gov (United States)

    Flexman, Alana M; Gooderham, Peter A; Griesdale, Donald E; Argue, Ruth; Toyota, Brian

    2017-06-01

    Although recruitment maneuvers have been advocated as part of a lung protective ventilation strategy, their effects on cerebral physiology during elective neurosurgery are unknown. Our objectives were to determine the effects of an alveolar recruitment maneuver on subdural pressure (SDP), brain relaxation score (BRS), and cerebral perfusion pressure among patients undergoing supratentorial tumour resection. In this prospective crossover study, patients scheduled for resection of a supratentorial brain tumour were randomized to undergo either a recruitment maneuver (30 cm of water for 30 sec) or a "sham" maneuver (5 cm of water for 30 sec), followed by the alternative intervention after a 90-sec equilibration period. Subdural pressure was measured through a dural perforation following opening of the cranium. Subdural pressure and mean arterial pressure (MAP) were recorded continuously. The blinded neurosurgeon provided a BRS at baseline and at the end of each intervention. During each treatment, the changes in SDP, BRS, and MAP were compared. Twenty-one patients underwent the study procedure. The increase in SDP was higher during the recruitment maneuver than during the sham maneuver (difference, 3.9 mmHg; 95% confidence interval [CI], 2.2 to 5.6; P < 0.001). Mean arterial pressure decreased further in the recruitment maneuver than in the sham maneuver (difference, -9.0 mmHg; 95% CI, -12.5 to -5.6; P < 0.001). Cerebral perfusion pressure decreased 14 mmHg (95% CI, 4 to 24) during the recruitment maneuver. The BRS did not change with either maneuver. Our results suggest that recruitment maneuvers increase subdural pressure and reduce cerebral perfusion pressure, although the clinical importance of these findings is thus far unknown. This trial was registered with ClinicalTrials.gov, NCT02093117.

  9. Impact of Denture Cleaning Method and Overnight Storage Condition on Denture Biofilm Mass and Composition: A Cross-Over Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Joke Duyck

    Full Text Available Appropriate oral hygiene is required to maintain oral health in denture wearers. This study aims to compare the role of denture cleaning methods in combination with overnight storage conditions on biofilm mass and composition on acrylic removable dentures.In a cross-over randomized controlled trial in 13 older people, 4 conditions with 2 different mechanical cleaning methods and 2 overnight storage conditions were considered: (i brushing and immersion in water without a cleansing tablet, (ii brushing and immersion in water with a cleansing tablet, (iii ultrasonic cleaning and immersion in water without a cleansing tablet, and (iv ultrasonic cleaning and immersion in water with a cleansing tablet. Each test condition was performed for 5 consecutive days, preceded by a 2-days wash-out period. Biofilm samples were taken at baseline (control and at the end of each test period from a standardized region. Total and individual levels of selected oral bacteria (n = 20, and of Candida albicans were identified using the Polymerase Chain Reaction (PCR technique. Denture biofilm coverage was scored using an analogue denture plaque score. Paired t-tests and Wilcoxon-signed rank tests were used to compare the test conditions. The level of significance was set at α< 5%.Overnight denture storage in water with a cleansing tablet significantly reduced the total bacterial count (p<0.01. The difference in total bacterial level between the two mechanical cleaning methods was not statistically significant. No significant effect was observed on the amount of Candida albicans nor on the analogue plaque scores.The use of cleansing tablets during overnight denture storage in addition to mechanical denture cleaning did not affect Candida albicans count, but reduced the total bacterial count on acrylic removable dentures compared to overnight storage in water. This effect was more pronounced when combined with ultrasonic cleaning compared to brushing

  10. Young Women's Ratings of Three Placebo Multipurpose Prevention Technologies for HIV and Pregnancy Prevention in a Randomized, Cross-Over Study in Kenya and South Africa.

    Science.gov (United States)

    Minnis, Alexandra M; Roberts, Sarah T; Agot, Kawango; Weinrib, Rachel; Ahmed, Khatija; Manenzhe, Kgahlisho; Owino, Fredrick; van der Straten, Ariane

    2018-03-20

    End-user input is critical to inform development of multipurpose prevention technology (MPT) products that prevent HIV and pregnancy. The TRIO Study, conducted in Kenya and South Africa, enrolled 277 HIV-negative women aged 18-30 in a randomized cross-over study to use each placebo MPT (daily oral tablets, monthly injections, and monthly vaginal ring) for one month. At the end of each month, participants rated how much they liked using the product on a 5-point Likert scale (5 = liked very much). We compared mean ratings using paired t-tests and examined sociodemographic-, attribute-, and behavior-related characteristics associated with ratings using multivariable linear regression and data from in-depth interviews. After use, mean ratings were significantly higher for injections [4.3 (SD = 1.0)] compared with tablets [3.0 (SD = 1.3)] and rings [3.3 (SD = 1.4)] (p < 0.001); mean ratings for rings were significantly higher than for tablets (p = 0.013). Mean ratings of a hypothetical active MPT increased for all products after the one-month period of use, with the greatest increase for rings, the least familiar product. In multivariable analysis, acceptability of key product attributes (e.g., product look) were associated with a significant increase of ≥ 1 point in the mean rating across all three products (p ≤ 0.001). Perceived ability to use the product without partner knowledge was associated with a higher mean rating for rings (b = 0.50; p = 0.006). The acceptability of product attributes contributed significantly to the rating of all products, highlighting the value of choice in pregnancy and HIV prevention to accommodate diverse users.

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

    Science.gov (United States)

    Shi, Yuanlu; Williamson, Gary

    2015-05-01

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

  12. A randomized, double-blind, crossover comparison of novel continuous bed motion versus traditional bed position whole-body PET/CT imaging

    Energy Technology Data Exchange (ETDEWEB)

    Schatka, Imke [Hannover Medical School, Department of Nuclear Medicine, Hannover (Germany); Charite, Department of Nuclear Medicine, Berlin (Germany); Weiberg, Desiree; Reichelt, Stephanie; Owsianski-Hille, Nicole; Derlin, Thorsten; Berding, Georg; Bengel, Frank M. [Hannover Medical School, Department of Nuclear Medicine, Hannover (Germany)

    2016-04-15

    Continuous bed motion has recently been introduced for whole-body PET/CT, and represents a paradigm shift towards individualized and flexible acquisition without the limitations of bed position-based planning. Increased patient comfort due to lack of abrupt table position changes may be another albeit still unproven advantage. For robust clinical implementation, image quality and quantitative accuracy should at least be equal to the prior standard of bed position-based step-and-shoot imaging. The study included 68 consecutive patients referred for whole-body PET/CT for various malignancies. The patients underwent traditional step-and-shoot and novel continuous bed motion acquisition in the same session in a randomized crossover design. The patients and two independent observers were blinded to the sequence of scan techniques. Patient comfort/satisfaction was examined using a standardized questionnaire. SUVs were compared for reference tissue (liver, muscle) and tumour lesions. PET image quality and misalignment with CT images were evaluated on a scale of 1 - 4. Patients preferred continuous bed motion over step-and-shoot (P = 0.0001). It was considered to be more relaxing (38 % vs. 8 %), quieter (34 % vs. 8 %), and more fluid (64 % vs. 8 %). Image quality, SUV and CT misalignment did not differ between the techniques. Continuous bed motion resulted in better end-plane image quality (P < 0.0001). Regardless of the technique, second examinations had significantly higher tumour lesion SUVmax values (P = 0.0002), and a higher CT misalignment score (P = 0.0017). Oncological PET/CT with continuous bed motion enhances patient comfort and is associated with image quality at least comparable to that with traditional bed position-based step-and-shoot acquisition. (orig.)

  13. Electrically Assisted Movement Therapy in Chronic Stroke Patients With Severe Upper Limb Paresis: A Pilot, Single-Blind, Randomized Crossover Study.

    Science.gov (United States)

    Carda, Stefano; Biasiucci, Andrea; Maesani, Andrea; Ionta, Silvio; Moncharmont, Julien; Clarke, Stephanie; Murray, Micah M; Millán, José Del R

    2017-08-01

    To evaluate the effects of electrically assisted movement therapy (EAMT) in which patients use functional electrical stimulation, modulated by a custom device controlled through the patient's unaffected hand, to produce or assist task-specific upper limb movements, which enables them to engage in intensive goal-oriented training. Randomized, crossover, assessor-blinded, 5-week trial with follow-up at 18 weeks. Rehabilitation university hospital. Patients with chronic, severe stroke (N=11; mean age, 47.9y) more than 6 months poststroke (mean time since event, 46.3mo). Both EAMT and the control intervention (dose-matched, goal-oriented standard care) consisted of 10 sessions of 90 minutes per day, 5 sessions per week, for 2 weeks. After the first 10 sessions, group allocation was crossed over, and patients received a 1-week therapy break before receiving the new treatment. Fugl-Meyer Motor Assessment for the Upper Extremity, Wolf Motor Function Test, spasticity, and 28-item Motor Activity Log. Forty-four individuals were recruited, of whom 11 were eligible and participated. Five patients received the experimental treatment before standard care, and 6 received standard care before the experimental treatment. EAMT produced higher improvements in the Fugl-Meyer scale than standard care (PFugl-Meyer points and 1 Fugl-Meyer point after the experimental treatment and standard care, respectively. The improvement was also significant in subjective reports of quality of movement and amount of use of the affected limb during activities of daily living (P<.05). EAMT produces a clinically important impairment reduction in stroke patients with chronic, severe upper limb paresis. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  14. Comparative effect of a new mouthrinse containing chlorhexidine, triclosan and zinc on volatile sulphur compounds: a randomized, crossover, double-blind study.

    Science.gov (United States)

    Mendes, L; Coimbra, J; Pereira, A L; Resende, M; Pinto, M G

    2016-08-01

    The aims of this study were to compare the volatile sulphur compounds (VSC)-reducing effect of two commercial mouthrinses using a morning bad breath model and to assess the role of mechanical plaque control (MPC) when performed previously to mouthrinse use. Eleven volunteers with good oral health were enrolled in a double-blind, randomized, six-step crossover design study with a 7-day washout period. Two commercial mouthrinses were tested using a saline solution (NaCl 0.9%) as a negative control: one mouthrinse contained 0.05% chlorhexidine, 0.05% cetylpyridinium chloride and 0.14% zinc lactate (CHX-CPC-Zn), while the other contained 0.05% chlorhexidine, 0.15% triclosan and 0.18% zinc pidolate (CHX-triclosan-Zn). A portable sulphide monitor (Halimeter(®) ) was used for VSC quantification. Measurements were made at baseline, and 1, 3 and 5 h after rinsing. Significant differences were detected by analysis of variance. No significant differences between groups were detected at baseline. We were unable to demonstrate a significant influence of mechanical plaque control on the reduction of VSC levels when performed before mouthrinse use (P = 0.631). Both mouthrinses effectively lowered VSC levels in all test intervals (P < 0.05). No statistically significant differences were found between mouthrinses in any of the test intervals (P = 0.629, 0.069 and 0.598 at 1, 3 and 5 h). This study demonstrated that CHX-CPC-Zn and CHX-triclosan-Zn have significant and similar effects in reducing VSC levels, which persist for at least 5 h. Such effects were independent of previous MPC, which failed to improve on the results of mouthrinse use alone. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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

    Science.gov (United States)

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

    2017-03-01

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

  16. Bioequivalence of lamotrigine 50-mg tablets in healthy male volunteers: a randomized, single-dose, 2-period, 2-sequence crossover study.

    Science.gov (United States)

    Perez-Lloret, S; Olmos, L; de Mena, F; Pieczanski, P; Rodriguez Moncalvo, J J

    2012-10-01

    OBEJCTIVE: To compare the bioavailability of two 50-mg lamotrigine dispersible tablet formulations (Epilepax®, Ivax-TEVA Argentina Laboratories, Argentina, as a test formulation, and Lamictal®, GlaxoSmithKline, UK, as a reference formulation) in 24 healthy male volunteers. This study was a randomized, 2-period, 2-sequence crossover design that was open for subjects and investigators, but blind for the bioanalytical lab. Serum samples were obtained over a 120-h interval. A 9-day wash-out period was allowed between treatments. The concentrations of lamotrigine were analyzed by high-performance liquid chromatography followed by ultraviolet-visible detection. Lamotrigine time-concentrations curves were obtained and the following pharmacokinetic parameters were calculated: AUC0-t, AUC0-inf and Cmax. Bioequivalence was declared if the 90% confidence interval (CI) of the mean test/reference ratios for AUC0-t, AUC0-inf and Cmax were within 80.00-125.00%. The geometric mean and respective 90% CI of test/reference percent ratios were 100.83% (92.53-107.88%) for AUC0-t, 99.91% (93.79-108.40%) for AUC0-inf, and 95.62% (90.91-100.57%) for Cmax. No serious adverse events were observed. 1 patient reported a mild rash following the administration of each formulation. This single dose study found that the test and reference products met the regulatory criteria for bioequivalence in this sample of fasting healthy volunteers. These results suggest that bioequivalence studies evaluating 50-mg doses of Lamotrigine are feasible and recommended, since such doses may minimize the risk of severe rash or Stevens-Johnson Syndrome. This study was registered at the Argentinean Clinical Trials National Registry (www.anmat.gov.ar), No 1666/2008. © Georg Thieme Verlag KG Stuttgart · New York.

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

    Science.gov (United States)

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

    2017-11-06

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

  18. No Acute Effects of Cannabidiol on the Sleep-Wake Cycle of Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study

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    Ila M. P. Linares

    2018-04-01

    Full Text Available Cannabidiol (CBD is a component of Cannabis sativa that has a broad spectrum of potential therapeutic effects in neuropsychiatric and other disorders. However, few studies have investigated the possible interference of CBD on the sleep-wake cycle. The aim of the present study was to evaluate the effect of a clinically anxiolytic dose of CBD on the sleep-wake cycle of healthy subjects in a crossover, double-blind design. Twenty-seven healthy volunteers that fulfilled the eligibility criteria were selected and allocated to receive either CBD (300 mg or placebo in the first night in a double-blind randomized design (one volunteer withdrew from the study. In the second night, the same procedure was performed using the substance that had not been administered in the previous occasion. CBD or placebo were administered 30 min before the start of polysomnography recordings that lasted 8 h. Cognitive and subjective measures were performed immediately after polysomnography to assess possible residual effects of CBD. The drug did not induce any significant effect (p > 0.05. Different from anxiolytic and antidepressant drugs such as benzodiazepines and selective serotonin reuptake inhibitors, acute administration of an anxiolytic dose of CBD does not seem to interfere with the sleep cycle of healthy volunteers. The present findings support the proposal that CBD do not alter normal sleep architecture. Future studies should address the effects of CBD on the sleep-wake cycle of patient populations as well as in clinical trials with larger samples and chronic use of different doses of CBD. Such studies are desirable and opportune.

  19. Commercially available gluten-free pastas elevate postprandial glycemia in comparison to conventional wheat pasta in healthy adults: a double-blind randomized crossover trial.

    Science.gov (United States)

    Johnston, C S; Snyder, D; Smith, C

    2017-09-20

    Given the popularity of gluten-free diets, research regarding the health implications of gluten-free (GF) products is necessary. This study compared the postprandial glycemic responses to three GF pastas commonly available in the U.S. market to that of wheat pasta in healthy adults. Thirteen healthy non-smoking men and women from a university campus population were enrolled in this randomized 4 × 4 block crossover study and completed all four treatments. Participants followed a standardized diet and activity protocol the day prior to testing, and one week separated testing periods. The test meal (a macaroni and cheese dish prepared with conventional wheat pasta or with GF pasta composed of either brown rice, rice and corn, or corn and quinoa flours) was consumed under observation, and blood was sampled in the fasted state and at one-half hour intervals for the first 2 hours following meal ingestion. A significant pasta × time interaction was observed for the incremental postprandial glycemia curves (p = 0.036, repeated measures ANOVA; effect size [partial eta squared], 0.943). Post-hoc analysis revealed a significant difference for the 30-minute postprandial blood glucose concentrations: the plasma glucose concentration was 57% higher for the GF rice and corn pasta compared to traditional wheat pasta (p = 0.011). Since postprandial glycemia was higher for GF pasta composed of rice and corn flours compared to wheat pasta, more research is needed to understand how the substitute ingredients for GF pastas impact health parameters and disease risk.

  20. Effect of width and boundary conditions on meeting maneuvers on two-way separated cycle tracks

    OpenAIRE

    García García, Alfredo; Agustin Gomez, Fernando; Llorca Garcia, Carlos; Angel-Domenech, Antonio

    2015-01-01

    Cycle track design guidelines are rarely based on scientific studies. In the case of off-road two-way cycle tracks, a minimum width must facilitate both passing and meeting maneuvers, being meeting maneuvers the most frequent. This study developed a methodology to observe meeting maneuvers using an instrumented bicycle, equipped with video cameras, a GPS tracker, laser rangefinders and speed sensors. This bicycle collected data on six two-way cycle tracks ranging 13-2.15 m width delimitated b...

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

    Directory of Open Access Journals (Sweden)

    Robabeh Soleimani

    2017-07-01

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

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

    Science.gov (United States)

    van der Made, Sanne M; Plat, Jogchum; Mensink, Ronald P

    2015-01-01

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

  3. A Randomized Cross-over Air Filtration Intervention Trial for Reducing Cardiovascular Health Risks in Residents of Public Housing near a Highway

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    Luz T. Padró-Martínez

    2015-07-01

    Full Text Available Exposure to traffic-generated ultrafine particles (UFP; particles <100 nm is likely a risk factor for cardiovascular disease. We conducted a trial of high-efficiency particulate arrestance (HEPA filtration in public housing near a highway. Twenty residents in 19 apartments living <200 m from the highway participated in a randomized, double-blind crossover trial. A HEPA filter unit and a particle counter (measuring particle number concentration (PNC, a proxy for UFP were installed in living rooms. Participants were exposed to filtered air for 21 days and unfiltered air for 21 days. Blood samples were collected and blood pressure measured at days 0, 21 and 42 after a 12-hour fasting period. Plasma was analyzed for high sensitivity C-reactive protein (hsCRP, interleukin-6 (IL-6, tumor necrosis factor alpha-receptor II (TNF-RII and fibrinogen. PNC reductions ranging from 21% to 68% were recorded in 15 of the apartments. We observed no significant differences in blood pressure or three of the four biomarkers (hsCRP, fibrinogen, and TNF-RII measured in participants after 21-day exposure to HEPA-filtered air compared to measurements after 21-day exposure to sham-filtered air. In contrast, IL-6 concentrations were significantly higher following HEPA filtration (0.668 pg/mL; CI = 0.465–0.959 compared to sham filtration. Likewise, PNC adjusted for time activity were associated with increasing IL-6 in 14- and 21-day moving averages, and PNC was associated with decreasing blood pressure in Lags 0, 1 and 2, and in a 3-day moving average. These negative associations were unexpected and could be due to a combination of factors including exposure misclassification, unsuccessful randomization (i.e., IL-6 and use of anti-inflammatory medicines, or uncontrolled confounding. Studies with greater reduction in UFP levels and larger sample sizes are needed. There also needs to be more complete assessment of resident time activity and of outdoor vs. indoor source

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

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    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

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

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    Sanne M van der Made

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

  6. Pursed-lips breathing reduces dynamic hyperinflation induced by activities of daily living test in patients with chronic obstructive pulmonary disease: A randomized cross-over study.

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    de Araujo, Cintia Laura Pereira; Karloh, Manuela; Dos Reis, Cardine Martins; Palú, Marina; Mayer, Anamaria Fleig

    2015-11-01

    Dynamic hyperinflation leads to dyspnoea and consequent limitations in functional capacity in chronic obstructive pulmonary disease. It has been shown that the response to pursed-lips breathing in terms of dynamic hyperinflation and lower-limb exercise capacity is variable, and its effects on activities of daily living are unknown. This study aimed to evaluate the effect of pursed-lips breathing on dynamic hyperinflation and functional capacity in patients with chronic obstructive pulmonary disease in a lower-limb exercise test and in a multiple-task activities of daily living test. Randomized cross-over study. Twenty-five patients with chronic obstructive pulmonary disease (16 men, mean age 64 ± 7 years, forced expiratory volume in 1 s (FEV1) = 41.7 ± 14.7% predicted). Patients randomly performed two 6-min walk tests (6MWT) with and without pursed-lips breathing (6MWT(PLB) and 6MWT(Non-PLB)) and two Glittre-ADL tests with and without pursed-lips breathing (TGlittre(PLB) and TGlittre(Non-PLB)). Inspiratory capacity was assessed at baseline and immediately after the tests. The 6MWT(Non-PLB) and TGlittre(Non-PLB) induced similar magnitude dynamic hyperinflation (0.22 ± 0.24 l and 0.31 ± 0.23 l, respectively; p > 0.05). Pursed-lips breathing did not improve dynamic hyperinflation induced by the 6MWT (0.24 ± 0.20 and 0.22 ± 0.24 l, respectively, with and without pursed-lips breathing; p > 0.05). Dynamic hyperinflation in the TGlittre(PLB) was significantly lower than in the TGlittre(Non-PLB) (0.19 ± 0.20 l and 0.31 ± 0.23 l, respectively; p = 0.02). Pursed-lips breathing did not improve 6MWT or TGlittre performance. Pursed-lips breathing reduced dynamic hyperinflation in the TGlittre, but not in the 6MWT. However, pursed-lips breathing did not improve functional capacity.

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

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    Anne Whittaker

    2015-05-01

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

  8. Bioequivalence of a biosimilar enoxaparin sodium to Clexane®after single 100 mg subcutaneous dose: results of a randomized, double-blind, crossover study in healthy volunteers.

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    Martínez González, Javier; Monreal, Mayte; Ayani Almagia, Ignacio; Llaudó Garín, Jordi; Ochoa Díaz de Monasterioguren, Lourdes; Gutierro Adúriz, Ibón

    2018-01-01

    To demonstrate the pharmacokinetic/pharmacodynamic (PK/PD) equivalence of a biosimilar enoxaparin to the reference drug, and to assess its safety and tolerability in healthy volunteers. A randomized, double-blind, crossover, 2-sequence, single-dose study was conducted in healthy volunteers of both sexes. Participants were sequentially and randomly administered single subcutaneous injections of enoxaparin 100 mg manufactured by Rovi (test; Madrid, Spain) and Clexane ® (enoxaparin 100 mg manufactured by Sanofi, reference) separated by a 1-week washout period. The primary PK/PD variables were maximum activity (A max ) and area under the effect curve from time 0 to the last measured activity (T) (AUEC 0-T ) and AUEC from time 0 to infinity (AUEC 0-inf ) of anti-FXa activity, and A max and AUEC 0-T of anti-FIIa activity. Secondary variables were A max and AUEC 0-T , AUEC 0-inf of tissue factor pathway inhibitor, and the ratio of AUEC 0-T anti-FXa to anti-FIIa activity. Biosimilarity would be shown when the 95% CI of the ratio of geometric least squares means (95% CI RGLSMs) of primary PK/PD parameters fell within the standard range of bioequivalence, ie, 80%-125%. The study sample consisted of 46 volunteers (33 males) aged 18-44 years and with body mass index ranging from 19.0 to 31.1 kg/m 2 . Three subjects did not complete the study. The curves of anti-FXa, anti-FIIa and tissue factor pathway inhibitor activities corresponding to administration of the test and reference products were comparable. The 95% CI RGLSMs of A max , AUEC 0-T and AUEC 0-inf for anti-FXa activity were 94.6%-105.9%, 99.8%-108.0% and 100.0%-108.6% respectively; A max and AUEC 0-T for anti-FIIa activity were 94.7%-112.6% and 90.9%-117.9% respectively. In addition, the 95% CI RGLSMs of all secondary variables fell within the range 80%-125%. The incidence and types of adverse events after administration of the test and reference drugs were similar. The results conclusively showed that the enoxaparin

  9. The effect of purslane seeds on glycemic status and lipid profiles of persons with type 2 diabetes: A randomized controlled cross-over clinical trial

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    Ahmad Esmaillzadeh

    2015-01-01

    Full Text Available Background: We are aware of limited data about the effects of purslane on diabetes. Earlier studies have mostly indicated the beneficial effects in animal models. This study aimed to evaluate the effect of purslane seeds on glycemic status and lipid profiles of persons with type 2 diabetes. Materials and Methods: This cross-over randomized controlled clinical trial was conducted on 48 persons with type 2 diabetes. Participants were randomly assigned to receive either 10 g/day purslane seeds with 240 cc low-fat yogurt (intervention group or only 240 cc low-fat yogurt (as a control group for 5 weeks. After a 2-week washout period, subjects were moved to the alternate arm for an additional 5 weeks. At baseline and end of each phase of the study, fasting blood samples were collected to quantify plasma glucose levels, as well as serum insulin and lipid profiles. Within-group and between-group changes in anthropometric measures, as well as biochemical indicators, were compared using a paired-samples t-test. Results: Mean age of study participants was 51.4 ± 6.0 year. We found a significant reduction in weight (−0.57 vs. 0.09 kg, P = 0.003 and body mass index (−0.23 vs. 0.02 kg/m 2 , P = 0.004 following purslane seeds consumption. Despite a slight reduction in fasting plasma glucose levels (−2.10 vs. −2.77 mg/dL, P = 0.90, we failed to find any significant effect on serum insulin levels and homeostatic model of assessment of insulin resistance score. Furthermore, purslane consumption decreased serum triglyceride levels (−25.5 vs. −1.8 mg/dL, P = 0.04 but could not affect serum high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and total cholesterol levels. We observed a significant reduction in systolic blood pressure (−3.33 vs. 0.5 mmHg, P = 0.01 and a borderline significant decrease in diastolic blood pressure (−3.12 vs. −0.93 mmHg, P = 0.09 after purslane seeds intake. Conclusion: In summary, consumption of

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

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

    2014-01-01

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

  11. The Effect of Sitting on Stability Balls on Nonspecific Lower Back Pain, Disability, and Core Endurance: A Randomized Controlled Crossover Study.

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    Elliott, Tessa Lillis Poirier; Marshall, Kyra Stanise; Lake, David Allen; Wofford, Nancy Henderson; Davies, George James

    2016-09-15

    Experimental randomized crossover. The aim of the study was to determine whether sitting on a ball for 90 min/d instead of a chair has an effect on low back pain (LBP), low back disability, and/or core muscle endurance. LBP may result from prolonged sitting. It has been proposed that replacing chairs with stability balls can diminish LBP in those who sit for prolonged periods. Research on the topic is sparse and inconclusive. A total of 90 subjects (university students, staff, and faculty, ages 18-65, who sit ≥4 hr/d) were randomly assigned to the intervention or control group for the first part of the study. Baseline data were collected: Oswestry Disability Index, a numerical pain rating scale for LBP, and four core muscle endurance tests. For 8 weeks, the control group sat on their usual chair. The intervention group sat on stability balls 5 d/wk, increasing up to 90 min/d. Baseline measurements were repeated postintervention. After a washout period, subjects switched groups, and the procedures were repeated-70 completed participation in control group and 76 in intervention group. There were no statistically significant differences for pain or disability in either group (P > 0.05). Changes in isometric trunk flexion (P = 0.001), nondominant side plank (P = 0.008), and Sorensen (P = 0.006) endurance scores were significant within the intervention group but not the control group. Between-group comparisons revealed a significant difference for isometric trunk flexion (P = 0.005) and Sorensen endurance times (P = 0.010). Analysis also showed that ball-sitting did not prevent an increase in LBP over the 8-week period. Ball-sitting had no significant effects on LBP or associated disability, but did improve core endurance in the sagittal plane. Although ball-sitting may be useful as an adjunct treatment for LBP when core muscles are involved, clinicians should rely on other, evidence-based treatments for LBP.

  12. Efficacy of a mandibular advancement appliance on sleep-disordered breathing in children: a study protocol of a crossover randomized controlled trial

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    Ghassan Idris

    2016-08-01

    Full Text Available Background: Sleep-Disordered Breathing (SDB varies from habitual snoring to partial or complete obstruction of the upper airway and can be found in up to 10% of children. SDB can significantly affect children’s wellbeing, as it can cause growth disorders, educational and behavioral problems, and even life-threatening conditions, such as cardiorespiratory failure. Adenotonsillectomy represents the primary treatment for pediatric SDB where adeno-tonsillar hypertrophy is indicated. For those with craniofacial anomalies, or for whom adenotonsillectomy or other treatment modalities have failed, or surgery is contra-indicated, mandibular advancement splints (MAS may represent a viable treatment option. Whilst the efficacy of these appliances has been consistently demonstrated in adults, there is little information about their effectiveness in children.Aims: To determine the efficacy of mandibular advancement appliances for the management of SDB and related health problems in children. Methods/design: The study will be designed as a single-blind crossover randomized controlled trial with administration of both an ‘Active MAS’ (Twin-block and a ‘Sham MAS’. Eligible participants will be children aged 8 to 12 years whose parents report they snore ≥ 3 nights per week. Sixteen children will enter the full study after confirming other inclusion criteria, particularly Skeletal class I or class II confirmed by lateral cephalometric radiograph. Each child will be randomly assigned to either a treatment sequence starting with the Active or the Sham MAS. Participants will wear the appliances for three weeks separated by a two-week washout period. For each participant, home-based polysomnographic data will be collected four times; once before and once after each treatment period. The Apnea Hypopnea Index (AHI will represent the main outcome variable. Secondary outcomes will include, snoring frequency, masseter muscle activity, sleep symptoms, quality

  13. Ranolazine versus placebo in patients with ischemic cardiomyopathy and persistent chest pain or dyspnea despite optimal medical and revascularization therapy: randomized, double-blind crossover pilot study

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    Shammas NW

    2015-03-01

    Full Text Available Nicolas W Shammas,1 Gail A Shammas,1 Kathleen Keyes,2 Shawna Duske,1 Ryan Kelly,1 Michael Jerin3 1Midwest Cardiovascular Research Foundation, 2Cardiovascular Medicine, Private Corporation, 3St Ambrose University, Davenport, IA, USA Background: Patients with ischemic cardiomyopathy (ICM may continue to experience persistent chest pain and/or dyspnea despite pharmacologic therapy and revascularization. We hypothesized that ranolazine would reduce anginal symptoms or dyspnea in optimally treated ICM patients.Methods: In this randomized, double-blind, crossover-design pilot study, 28 patients with ICM (ejection fraction less or equal 40% were included after providing informed consent. A total of 24 patients completed both placebo and ranolazine treatments and were analyzed. All patients were on treatment with a beta blocker, an angiotensin-converting enzyme inhibitor (or angiotensin receptor blocker, and at least one additional antianginal drug. After randomization, patients received up to 1,000 mg ranolazine orally twice a day, as tolerated, versus placebo. The primary end point was change in angina as assessed by the Seattle Angina Questionnaire (SAQ, or in dyspnea as assessed by the Rose Dyspnea Scale (RDS. Change in the RDS and SAQ score from baseline was compared, for ranolazine and placebo, using the Wilcoxon signed rank test or paired t-test.Results: Patients had the following demographic and clinical variables: mean age of 71.5 years; male (82.1%; prior coronary bypass surgery (67.9%; prior coronary percutaneous intervention (85.7%; prior myocardial infarction (82.1%; diabetes (67.9%; and mean ejection fraction of 33.1%. No statistical difference was seen between baseline RDS score and that after placebo or ranolazine (n=20 (P≥0.05. There was however, an improvement in anginal frequency (8/10 patients (P=0.058, quality of life (8/10 patients (P=0.048, and mean score of all components of the SAQ questionnaire (n=10 (P=0.047 with ranolazine

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

    Science.gov (United States)

    Atkinson, Jo-An; Bobogare, Albino; Vallely, Andrew; Boaz, Leonard; Kelly, Gerard; Basifiri, William; Forsyth, Simon; Baker, Peter; Appleyard, Bridget; Toaliu, Hilson; Williams, Gail

    2009-12-16

    A key component of the malaria elimination strategy in Solomon Islands (SI) is widespread coverage of long-lasting insecticidal nets (LLINs). The success of this strategy is dependent on LLIN acceptability and compliance. There has been unresolved debate among policy makers and donors as to which type of LLIN would be most appropriate for large-scale distribution in SI, and anecdotal reports of a lack of acceptability of certain brands of LLINs. A cluster randomized controlled crossover bed net acceptability and preference trial was therefore carried out from July to September, 2008 to inform policy and to facilitate community engagement and participation in the selection of the most appropriate LLIN for use in SI. A three-stage sampling method was used to randomly select the study population from Malaita Province, SI. Three brands of LLINs were assessed in this study: Olyset, PermaNet and DuraNet. Bed net acceptability and preference were evaluated through surveys at three defined time points after short and longer-term trial of each LLIN. The acceptability of PermaNet after short-term use (96.5%) was significantly greater than Olyset (67.3%, p < 0.001) and DuraNet (69.8%, p < 0.001). The acceptability of DuraNet and Olyset after short-term use was not significantly different at the 5% level. LLINs that were perceived not to prevent mosquito bites were significantly less acceptable than LLINs that were perceived to prevent mosquito bites (OR 0.15; 95%CI 0.03 to 0.6). LLINs that allow a pleasant night's sleep (OR 6.3; 95%CI:3.3-12.3) and have a soft texture (OR 5.7; 95%CI:1.9-20.5) were considered more acceptable than those that did not. Olyset's acceptability decreased over time and this was due to net wrinkling/shrinkage after washing resulting in reduced efficiency in preventing mosquito bites. The increase in DuraNet acceptability was a result of a reduction in minor adverse events following longer-term use. This research was conducted to inform LLIN

  15. Effect of Co-Administration of Lidocaine on the Pain and Pharmacokinetics of Intramuscular Amikacin in Children with Multidrug-Resistant Tuberculosis: A Randomized Crossover Trial.

    Science.gov (United States)

    Garcia-Prats, Anthony J; Rose, Penelope C; Draper, Heather R; Seddon, James A; Norman, Jennifer; McIlleron, Helen M; Hesseling, Anneke C; Schaaf, H Simon

    2018-03-14

    Currently recommended treatment for multidrug-resistant (MDR) tuberculosis (TB) includes 4-8 months of an injectable medication, which is poorly tolerated. We evaluated the impact of co-administering lidocaine on pain and pharmacokinetics of intramuscular injections of amikacin in children with MDR-TB. Children 8-18 years of age, receiving amikacin for MDR-TB treatment in Cape Town, South Africa, were eligible for this randomized crossover trial. Participants received a 15 mg/kg dose of intramuscular amikacin with and without additional lidocaine (0.2-0.4 mg/kg) on different days, and were randomized to the order of the treatments (the sequence). Participants and staff completing evaluations were blinded to sequence. Samples were drawn pre-dose, and at 1, 2, 4, 6 and 8 hours post-dose for measurement of plasma amikacin concentrations. Pain was assessed by participants using the Wong Baker FACES pain scale (0 to 5) pre-dose, immediately after the injection and then at 30 and 60 minutes. Pharmacokinetic measures were calculated using noncompartmental analysis. Twelve children were included, median age 11.5 years (IQR 9.9-13.4y). Participant-reported pain scores immediately after the amikacin injection were lower when lidocaine was co-administered: 1.0 (IQR 0.5-2.0) with lidocaine vs. 2.5 (1.0-4.0) without lidocaine (p=0.004). The median area under the concentration time curve (AUC)0-8 and median maximum plasma concentration (Cmax) of amikacin were 109.0 μg*h/mL (IQR 84.7-121.3) and 36.7 μg/mL (IQR 34.1-40.5) with lidocaine compared to 103.3 μg*h/mL (IQR 81.7-135.0; p=0.814) and 34.1 μg/mL (IQR 35.6-46.4; p=0.638) without lidocaine, respectively. The co-administration of lidocaine resulted in reduced pain immediately after the injection and did not alter amikacin AUC or Cmax.

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

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    Jun Takeshita

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

  17. A randomized, double-blind, placebo-controlled crossover study of the effects of levetiracetam on cognition, mood, and balance in healthy older adults.

    Science.gov (United States)

    Schoenberg, Mike R; Rum, Ruba S; Osborn, Katie E; Werz, Mary Ann

    2017-09-01

    The cognitive and mood effects of levetiracetam (LEV) in older adults are not known. This study compared the cognitive and mood effects of LEV to placebo in healthy older adults. Cognitive, mood, and balance variables were compared between LEV and placebo using a randomized, double-blind, placebo-controlled crossover study with two 5-week treatment periods. Healthy volunteers (n = 20) aged 65-80 (mean age 72.4) received either LEV or placebo in which the LEV target dose was 1,000 mg/day. Volunteers, aged 65-80, were without epilepsy to limit potentially confounding the impact of seizures and/or underlying neuropathology on outcomes. LEV was initiated at 250 mg twice a day for 2 weeks, then increased to 500 mg twice a day for 2 weeks, and then tapered to 250 mg twice a day for 1 week. This was randomized with placebo for the two treatment arms. Measures included standardized neuropsychological, mood, and balance tests yielding 32 variables. Balance was assessed using subjective report (e.g., A-B neurotoxicity scale) and objective data (e.g., Berg Balance Scale). Average LEV serum concentration was 16.9 (standard deviation [SD} 7.7). Repeated-measures analysis of variance (ANOVA) found no differences between LEV and placebo phases for 29 (90.6%) of 32 variables including no change in balance. Performance on LEV was better than placebo on a visual memory (MCG Complex Figure Recall; p = 0.007) and two attention tests (Trail Making Test, Part A, p = 0.009; Stroop Interference, p = 0.004). There was a trend for greater irritability and fatigue (POMS Anger and Fatigue) during the LEV phase (p = 0.029, p = 0.035). Effect-size changes were generally small (Cohen d balance. When anticonvulsant medication is indicated for older adults, LEV has pharmacokinetic advantages, and these data indicate no adverse impact on cognition or balance. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

  18. Impact of a nurse led telephone intervention on satisfaction and health outcomes of children with inflammatory rheumatic diseases and their families: a crossover randomized clinical trial.

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