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Sample records for single oral morning

  1. The effect of a tooth/tongue gel and mouthwash regimen on morning oral malodour : A 3-week single-blind randomized clinical trial

    NARCIS (Netherlands)

    van der Sluijs, E.; Van der Weijden, G.A.; Hennequin-Hoenderdos, N.L.; Slot, D.E.

    2018-01-01

    Aim: To compare the effects of a regimen consisting of a tooth/tongue gel, tongue cleaner and mouthwash with the effects of using standard fluoride dentifrice on the organoleptic oral malodour score (ORG) and volatile sulphur compounds (VSCs). Materials and methods: A total, 66 non-dental students

  2. Morning administration of oral methamphetamine dose-dependently disrupts nighttime sleep in recreational stimulant users.

    Science.gov (United States)

    Herrmann, Evan S; Johnson, Patrick S; Bruner, Natalie R; Vandrey, Ryan; Johnson, Matthew W

    2017-09-01

    Use of amphetamine-type stimulants (e.g., methamphetamine) is associated with acute sleep disruptions. No prior reports have characterized the acute effects of methamphetamine on sleep using polysomnography, the gold standard for objective sleep monitoring. Recreational stimulant users (n=19) completed a baseline assessment, which included questionnaires assessing demographic and substance use characteristics, and the Pittsburgh Sleep Quality Index (PSQI), which assesses sleep quality over the past month. Participants were administered 0mg (placebo), 20mg, or 40mg oral methamphetamine at 08:15h on study days, using a double-blind, randomized, within-subjects design. Sleep was monitored using polysomnography from 22:20 that evening until 06:15 the following morning. PSQI scores indicated more than half of participants reported poor sleep quality at baseline. Methamphetamine dose-dependently increased sleep latency, and decreased total sleep time, sleep efficiency, time in NREM 2 sleep, number of REM periods, and total time in REM sleep. Sleep under placebo conditions was consistent with what would be expected from healthy adults. Morning oral administration of methamphetamine produces robust disruptions in nighttime sleep. Future research should examine relations between stimulant use and sleep disruption in naturalistic settings, with regard to both stimulant abuse and licit prescription use. Copyright © 2017. Published by Elsevier B.V.

  3. Impact of different oral hygiene aids for the reduction of morning bad breath among dental students: a crossover clinical trial.

    Science.gov (United States)

    Godha, Shaijal; Dasar, Pralhad L; Sandesh, N; Mishra, Prashant; Kumar, Sandeep; Balsaraf, Swati; Bhadauria, Upendra Singh; Vyas, Shaleen

    2016-01-01

    To assess and compare the effects of different oral hygiene procedures on the reduction of morning bad breath, plaque and gingival status in healthy subjects. A four step cross-over trial was performed on 32 study subjects. They were allocated into four groups: Group I: tooth brushing; Group II: tooth brushing and tongue scraping; Group III: tooth brushing and mouth washing; and Group IV: tooth brushing, tongue scraping and use of mouthwash. A washout interval of 7 days was employed. At the beginning and at the end of all intervention periods, breath score was measured by hand held sulfide monitor (Breath Alert) at four time intervals. The Plaque and Gingival status was evaluated using Plaque and Gingival Index. The highest reduction in mean breath score (2.12±0.65), plaque score (0.75±0.47) and gingival score (0.67±0.41) were found in the Group IV followed by Group II and Group III. A significant positive correlation was observed between plaque scores and gingival scores before intervention (r=0.443; p value<0.001) and after intervention (r=0.846; p value<0.001). The study findings suggest that mechanical aids in conjunction with chemical regimens are considered as the most effective method for reducing the morning bad breath in healthy subjects and should be incorporated in daily oral hygiene practices.

  4. Morning Sickness

    Science.gov (United States)

    ... stay in the hospital for treatment. What is hyperemesis gravidarum? About 3 in 100 women (3 percent) may have a severe kind of morning sickness called hyperemesis gravidarum. This is extreme, excessive nausea and vomiting during ...

  5. Single oral paracoccidioidomycosis mimicking other lesions: report of eight cases.

    Science.gov (United States)

    de Oliveira Gondak, Rogério; Mariano, Fernanda Viviane; dos Santos Silva, Alan Roger; Vargas, Pablo Agustin; Lopes, Márcio Ajudarte

    2012-01-01

    Paracoccidioidomycosis is a fungal infection caused by Paracoccidioides brasiliensis. It is an endemic disease, representing a serious health problem in Latin American countries. This infection primarily affects the lungs and is acquired by inhalation of the fungus. It can spread to other organs and tissues, mainly the oral cavity affecting more adult men from 30 to 50 years of age. On clinical presentation, several signs associated with impaired general and nutritional conditions can be noted. Oral manifestation is more common in the soft palate, gingiva, lower lip, buccal mucosa, and tongue. The classical clinical presentation is a superficial ulcer with granular appearance and hemorrhagic points. Usually, the oral lesion is extensive and generalized. Although uncommon, when the oral manifestation is single, others lesions, particularly squamous cell carcinoma, must be included in the differential diagnosis. In this article, the authors discuss the unusual presentation of eight cases of single oral paracoccidioidomycosis and its diagnostic importance.

  6. Morning-After Pill

    Science.gov (United States)

    ... isn't recommended. Side effects of the morning-after pill typically last only a few days and may include: Nausea or vomiting Dizziness Fatigue ... pregnancy. If you have unprotected sex in the days and weeks after taking the morning-after pill, you're at risk of becoming pregnant. Be ...

  7. Validation and comparison of three formulae to estimate sodium and potassium excretion from a single morning fasting urine compared to 24-h measures in 11 countries.

    Science.gov (United States)

    Mente, Andrew; O'Donnell, Martin J; Dagenais, Gilles; Wielgosz, Andy; Lear, Scott A; McQueen, Matt J; Jiang, Ying; Xingyu, Wang; Jian, Bo; Calik, K Burco T; Akalin, Ayse A; Mony, Prem; Devanath, Anitha; Yusufali, Afzal H; Lopez-Jaramillo, Patricio; Avezum, Alvaro; Yusoff, Khaled; Rosengren, Annika; Kruger, Lanthe; Orlandini, Andrés; Rangarajan, Sumathi; Teo, Koon; Yusuf, Salim

    2014-05-01

    Although 24-h urinary measure to estimate sodium and potassium excretion is the gold standard, it is not practical for large studies. We compared estimates of 24-h sodium and potassium excretion from a single morning fasting urine (MFU) using three different formulae in healthy individuals. We studied 1083 individuals aged 35-70 years from the general population in 11 countries. A 24-h urine and MFU specimen were obtained from each individual. A subset of 448 individuals repeated the measures after 30-90 days. The Kawasaki, Tanaka, and INTERSALT formulae were used to estimate urinary excretion from a MFU specimen. The intraclass correlation coefficient (ICC) between estimated and measured sodium excretion was higher with Kawasaki (0.71; 95% confidence interval, CI: 0.65-0.76) compared with INTERSALT (0.49; 95% CI: 0.29-0.62) and Tanaka (0.54; 95% CI: 0.42-0.62) formulae (P <0.001). For potassium, the ICC was higher with the Kawasaki (0.55; 95% CI: 0.31-0.69) than the Tanaka (0.36; 95% CI: -0.07 to 0.60; P <0.05) formula (no INTERSALT formula exists for potassium). The degree of bias (vs. the 24-h urine) for sodium was smaller with Kawasaki (+313 mg/day; 95% CI: +182 to +444) compared with INTERSALT (-872 mg/day; 95% CI: -728 to -1016) and Tanaka (-548 mg/day; 95% CI: -408 to -688) formulae (P <0.001 and P = 0.02, respectively). Similarly for potassium, the Kawasaki formula provided the best agreement and least bias. Blood pressure correlated most closely and similarly with the 24-h and Kawasaki estimates for sodium compared with the other two formulae. In a diverse population, the Kawasaki formula is the most valid and least biased method of estimating 24-h sodium excretion from a single MFU and is suitable for population studies.

  8. Single oral dose safety of D-allulose in dogs.

    Science.gov (United States)

    Nishii, Naohito; Nomizo, Toru; Takashima, Satoshi; Matsubara, Tatsuya; Tokuda, Masaaki; Kitagawa, Hitoshi

    2016-07-01

    Healthy dogs were administered acute oral doses of D-allulose (also called D-psicose) to evaluate its toxicity. Six dogs received oral doses of either a placebo or D-allulose solution (1 and 4 g/kg) on three different study days. One dog experienced vomiting, and five dogs showed transient diarrhea when 4 g/kg of D-allulose was administered. All dogs were active and had a good appetite throughout the study period. Blood glucose concentration slightly decreased without a rise in plasma insulin concentration 2 hr after D-allulose administration. Plasma alkaline phosphatase activities showed a mild increase between 12 and 48 hr after D-allulose administration. These data suggested that a single oral dose of D-allulose does not show severe toxicity in dogs.

  9. Vaxchora: A Single-Dose Oral Cholera Vaccine.

    Science.gov (United States)

    Cabrera, Adriana; Lepage, Jayne E; Sullivan, Karyn M; Seed, Sheila M

    2017-07-01

    To review trials evaluating the efficacy and safety of Vaxchora, a reformulated, single-dose, oral, lyophilized Vibrio cholerae CVD 103-HgR vaccine for the prevention of travel-related cholera caused by V cholerae serogroup O1. A literature search was conducted using MEDLINE (1946 to January week 3, 2017) and EMBASE (1996 to 2017 week 3). Keywords included oral cholera vaccine, single-dose, Vaxchora, and CVD 103-HgR. Limits included human, clinical trials published in English since 2010. ClinicalTrials.gov was used as a source for unpublished data. Additional data sources were obtained through bibliographic review of selected articles. Studies that addressed the safety and efficacy of Vaxchora, the reformulated, single-dose oral CVD 103-HgR cholera vaccine, were selected for analysis. Approval of Vaxchora, was based on efficacy of the vaccine in human trials demonstrating 90.3% protection among those challenged with V cholerae 10 days after vaccination and in immunogenicity studies with 90% systemic vibriocidal antibody conversion at 6 months after a single-dose of vaccine. Tolerability was acceptable, with the most common adverse effects reported to be fatigue, headache, and abdominal pain. Vaxchora is the only FDA-approved, single-dose oral vaccine for the prevention of cholera caused by V cholerae serogroup O1 in adult travelers from the United States going to cholera-affected areas. Safety and efficacy has not been established in children, immunocompromised persons, and pregnant or breastfeeding women or those living in cholera-endemic areas.

  10. Single dose oral piroxicam for acute postoperative pain

    Science.gov (United States)

    Moore, R Andrew; Edwards, Jayne; Loke, Yoon; Derry, Sheena; McQuay, Henry J

    2014-01-01

    Background This is an updated version of the original Cochrane review published in Issue 2, 2000. Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) with analgesic properties, and is used mainly for treating rheumatic disorders. Some drugs have been directly compared against each other within a trial setting to determine their relative efficacies, whereas other have not. It is possible, however, to compare analgesics indirectly by examining the effectiveness of each drug against placebo when used in similar clinical situations. Objectives To determine the analgesic efficacy and adverse effects of single-dose piroxicam compared with placebo in moderate to severe postoperative pain. To compare the effects of piroxicam with other analgesics. Search methods Published studies were identified from systematic searching of MEDLINE, Biological Abstracts, EMBASE, CENTRAL and the Oxford Pain Relief Database in December 2007. Additional studies were identified from the reference lists of retrieved reports. Selection criteria The following inclusion criteria were used: full journal publication, randomised placebo controlled trial, double-blind design, adult participants, postoperative pain of moderate to severe intensity at the baseline assessment, postoperative administration of oral or intramuscular piroxicam. Data collection and analysis Summed pain intensity and pain relief data were extracted and converted into dichotomous information to yield the number of participants obtaining at least 50% pain relief. This was used to calculate estimates of relative benefit and number-needed-to-treat-to-benefit (NNT) for one participant to obtain at least 50% pain relief. Information was collected on adverse effects and estimates of relative risk and number-needed-to-treat-to-harm (NNH) were calculated. Main results In this update no further studies were found. The original search identified three studies (141 participants) which compared oral piroxicam 20 mg with placebo and

  11. Morning Programs Revisited.

    Science.gov (United States)

    Black, Susan

    1993-01-01

    Like British morning programs of recent decades, upstate New York program encourages parents and community residents to get involved in children's education. Parents and community residents--watercolor artists, auto mechanics, doll collectors, and others--are welcomed and valued in schools. Program's purpose is learning, not entertainment. Topics…

  12. Single dose oral tenoxicam for acute postoperative pain in adults.

    Science.gov (United States)

    Moore, Owen A; McIntyre, Mairead; Moore, R Andrew; Derry, Sheena; McQuay, Henry J

    2009-07-08

    Tenoxicam is a non-steroidal anti-inflammatory drug (NSAID) licensed for use in rheumatic disease and other musculoskeletal disorders in the UK, and is widely available in other countries worldwide. This review sought to evaluate the efficacy and safety of oral tenoxicam in acute postoperative pain, using clinical studies of patients with established pain, and with outcomes measured primarily over 6 hours using standard methods. This type of study has been used for many decades to establish that drugs have analgesic properties. To assess the efficacy of single dose oral tenoxicam in acute postoperative pain, and any associated adverse events. We searched The Cochrane Library (Issue 1, 2009), MEDLINE (March 2009); EMBASE via Ovid (March 2009); the Oxford Pain Relief Database. Randomised, double-blind, placebo-controlled clinical trials of oral tenoxicam for relief of acute postoperative pain in adults. Two review authors independently assessed trial quality and extracted data. The area under the "pain relief versus time" curve was used to derive the proportion of participants with tenoxicam experiencing least 50% pain relief over 4 to 6 hours, using validated equations. The number needed to treat to benefit (NNT) was calculated using 95% confidence intervals (CI). The proportion of participants using rescue analgesia over a specified time period, and time to use of rescue analgesia, were sought as additional measures of efficacy. Information on adverse events and withdrawals was also collected. Not one of sixteen studies identified by the searches and examined in detail studied oral tenoxicam in patients with established postoperative pain and therefore no results are available. In the absence of evidence of efficacy for oral tenoxicam in acute postoperative pain, its use in this indication is not justified at present. Because trials clearly demonstrating analgesic efficacy in the most basic of acute pain studies is lacking, use in other indications should be

  13. [Early morning hypertension/morning blood pressure surge].

    Science.gov (United States)

    Hoshide, Satoshi; Kario, Kazuomi

    2014-08-01

    Early morning hypertension and morning blood pressure surge have been reported to be associated with organ damage and cardiovascular events. The concept of early morning hypertension and morning blood pressure surge is sometimes discussed in the same arena, and provides partly overlapping information concerning their mechanism or risk profile. However, what is different between groups is as follows. First, early morning hypertension is blood pressure level, while morning blood pressure surge is variability of blood pressure. Second, the intervention of early morning hypertension is available, which lead to prevent the progression of organ damage or cardiovascular event, but there is not enough evidence whether the reduction of morning blood pressure surge would reduce cardiovascular outcome.

  14. A pharmacokinetic/pharmacodynamic study comparing a single morning dose of adderall to twice-daily dosing in children with ADHD.

    Science.gov (United States)

    Greenhill, Laurence L; Swanson, James M; Steinhoff, Ken; Fried, Jane; Posner, Kelly; Lerner, Marc; Wigal, Sharon; Clausen, Susan B; Zhang, Yuxin; Tulloch, Simon

    2003-10-01

    To determine the pharmacokinetic and pharmacodynamic properties of once-daily versus twice-daily doses of Adderall. Following a 1-week wash-out, 12 subjects with attention-deficit/hyperactivity disorder (ADHD) entered a double-blind crossover study comparing two conditions: QD (10 mg of Adderall at 7:30 a.m. and placebo at noon) or BID (10 mg of Adderall at 7:30 a.m. and at noon). At two sites, cohorts of six subjects each were assessed on two different days by a 12-hour laboratory school protocol. Plasma concentrations of d- and l-amphetamine, vital signs, teacher ratings of classroom behavior on the SKAMP, and 10-minute Math Test performance were measured repeatedly over 12 hours. An analysis of variance used center, subject-within-center, condition, and time-after-second-dose as independent variables. The pharmacokinetic profiles revealed similar morning concentrations of d- and l-amphetamine. However, concentrations were twice as high in the afternoon for BID as QD. The two conditions showed similar pharmacodynamic profiles in the morning, although improvement in math performance and behavior was maintained into the afternoon only in the BID condition (p Adderall may be an effective strategy for afternoon control of attention and deportment for children with ADHD.

  15. Oral contraception does not alter single dose saquinavir pharmacokinetics in women

    Science.gov (United States)

    Fröhlich, Margit; Burhenne, Jürgen; Martin-Facklam, Meret; Weiss, Johanna; von Wolff, Michael; Strowitzki, Thomas; Walter-Sack, Ingeborg; Haefeli, Walter E

    2004-01-01

    Aims Women experience more adverse drug reactions (ADR) to antiretroviral therapy than men. This may be attributed to higher plasma concentrations of protease inhibitors due to pharmacokinetic interactions with hormonal preparations. Thus, in the present study we aimed to investigate the influence of oral contraceptives (OC) on the pharmacokinetics of the protease inhibitor saquinavir. Methods Saquinavir was administered in a hard gelatin capsule formulation (Invirase®) to rule out confounding by pharmaceutical aids of the more frequently used soft gelatin capsule. After an overnight fast, eight healthy female participants ingested a single oral dose of 600 mg saquinavir immediately before and after the 19th dose of a combined, low dose OC (0.03 mg ethinylestradiol, 0.075 mg gestodene) in a prospective, fixed sequence study design. The first saquinavir application was scheduled on day 1, 2, or 3 of the individual menstrual cycle. Plasma concentrations of saquinavir and relative concentrations of its M2&M3-hydroxy metabolites were determined by LC/MS/MS for 48 h. Results Intake of OC resulted in a significant decrease in morning serum concentrations (before intake of OC, compared to day 19 of OC therapy) of 17β-estradiol by −23.4 pg ml−1 (57%, 95%CI: −76% to −37.4%); progesterone by −0.25 ng ml−1 (33%, 95%CI: −45.3% to −21.5%); follicle-stimulating hormone by −4.06 U l−1 (82%, 95%CI: −96.5% to −67.7%); and luteinizing hormone by −3.49 U l−1 (74%, 95%CI: −93 to −54.6%). Conversely, sexual hormone binding globulin serum concentrations increased by 83.6 nmol l−1 (205%, 95%CI: 32.2% to 377%). Pharmacokinetic parameters of saquinavir (AUC, Cmax, tmax, t1/2, CLR) were not affected by OC, nor was the relative metabolic ratio of saquinavir/M2&M3-hydroxy saquinavir. Furthermore, there was no association of serum hormone concentrations or MDR1-polymorphisms (C3435T and G2677T) with pharmacokinetic parameters of saquinavir. Conclusions There

  16. Morning and evening exercise

    Directory of Open Access Journals (Sweden)

    Dae Yun Seo

    2013-12-01

    Full Text Available A growing body of evidence suggests that exercise may contribute to preventing pathological changes, treating multiple chronic diseases, and reducing mortality and morbidity ratios. Scientific evidence moreover shows that exercise plays a key role in improving health-related physical fitness components and hormone function. Regular exercise training is one of the few strategies that has been strictly adapted in healthy individuals and in athletes. However, time-dependent exercise has different outcomes, based on the exercise type, duration, and hormone adaptation. In the present review, we therefore briefly describe the type, duration, and adaptation of exercise performed in the morning and evening. In addition, we discuss the clinical considerations and indications for exercise training.

  17. Comparison between the impact of morning and evening doses of rivaroxaban on the circadian endogenous coagulation rhythm in healthy subjects.

    Science.gov (United States)

    Brunner-Ziegler, S; Jilma, B; Schörgenhofer, C; Winkler, F; Jilma-Stohlawetz, P; Koppensteiner, R; Quehenberger, P; Seger, C; Weigel, G; Griesmacher, A; Brunner, M

    2016-02-01

    ESSENTIALS: It is unknown whether single rivaroxaban doses should best be administered in the morning or evening. Circadian rhythm of coagulation/fibrinolysis was measured after morning or evening intake of rivaroxaban. Evening intake of rivaroxaban leads to prolonged exposure to rivaroxaban concentrations. Evening intake of rivaroxaban better matches the morning hypofibrinolysis. A circadian variation of the endogenous coagulation system exists with hypercoagulability and hypofibrinolysis and a corresponding peak of cardiovascular thromboembolic events in the morning. So far, no information is given as to whether single daily doses of the new oral anticoagulant drug rivaroxaban should best be administered in the morning or the evening. Sixteen healthy male or female volunteers with a mean age of 26 ± 7 years were included in this randomized, controlled, analyst-blinded cross-over clinical trial. All subjects were given three morning and three evening single doses of 10 mg rivaroxaban. Circadian rhythms of prothrombin fragment 1 + 2, plasminogen activator inhibitor, and plasmin-antiplasmin complex were measured before any medication intake, as well as after morning or evening medication intake. Rivaroxaban concentrations were determined by an anti-activated factor X assay and liquid chromatography-mass spectrometry. Concentrations of rivaroxaban were higher 12 h after evening intake of rivaroxaban than 12 h after morning intake (53.3 ng mL(-1) [95% confidence interval 46.0-67.8] vs. 23.3 ng mL(-1) [19.4-29.1, respectively]). Rivaroxaban intake in the evening reduced morning F1+2 concentrations better at 8:00 AM than did administration on awakening (85 ± 25 nmol L(-1) vs. 106 ± 34 nmol L(-1) , CI: 9.4-32.1). In addition, this suppression effect was longer lasting after evening intake. Evening intake of rivaroxaban leads to prolonged exposure to rivaroxaban concentrations and better matches the morning hypofibrinolysis. These results might help to further improve

  18. Pharmacokinetics of Solithromycin (CEM-101) after Single or Multiple Oral Doses and Effects of Food on Single-Dose Bioavailability in Healthy Adult Subjects▿

    OpenAIRE

    Still, J. Gordon; Schranz, Jennifer; Degenhardt, Thorsten P.; Scott, Drusilla; Fernandes, Prabhavathi; Gutierrez, Maria J.; Clark, Kay

    2011-01-01

    The pharmacokinetics of orally administered solithromycin (CEM-101), a novel fluoroketolide, were evaluated in healthy subjects in three phase 1 studies. In two randomized, double-blinded, placebo-controlled studies, escalating single oral doses of solithromycin (50 to 1,600 mg) or seven oral daily doses (200 to 600 mg) of solithromycin were administered. A third study evaluated the effects of food on the bioavailability of single oral doses (400 mg) of solithromycin. Following single doses, ...

  19. No significant effects of single intravenous, single oral and subchronic oral administration of acetylcholinesterase inhibitors on striatal [{sup 123}I]FP-CIT binding in rats

    Energy Technology Data Exchange (ETDEWEB)

    Knol, R.J.J.; Booij, J. [University of Amsterdam, Department of Nuclear Medicine, Academic Medical Center, Amsterdam (Netherlands); Graduate School of Neurosciences, Amsterdam (Netherlands); Bruin, K. de; Eck-Smit, B.L.F. van [University of Amsterdam, Department of Nuclear Medicine, Academic Medical Center, Amsterdam (Netherlands)

    2008-03-15

    [{sup 123}I]FP-CIT SPECT is a valuable diagnostic tool to discriminate Lewy body dementia from Alzheimer's dementia. To date, however, it is uncertain whether the frequently used acetylcholinesterase inhibitors (AChEIs) by demented patients, have an effect on [{sup 123}I]FP-CIT binding to dopamine transporters (DATs). Earlier animal studies showed a decline of DAT availability after acute intravenous injection of AChEIs. The aim of this study was to investigate effects of single intravenous, single oral and subchronic oral administration of AChEIs on DAT availability in the rat brain as measured by [{sup 123}I]FP-CIT. Biodistribution studies were performed in Wistar rats (n = 5-16 per group). Before [{sup 123}I]FP-CIT injection, rats were injected intravenously with a single dose of the AChEI rivastigmine (2.5 mg/kg body weight) or donepezil (0.5 mg/kg), the DAT-blocker methylphenidate (10 mg/kg) or saline. A second group was orally treated with a single dose of rivastigmine or donepezil (2.5 mg/kg), methylphenidate (10 mg/kg) or saline before injection of [{sup 123}I]FP-CIT. Studies were also performed in rats that were orally treated during 14 consecutive days with either rivastigmine (1 mg/kg daily), donepezil (1.5 mg/kg daily), methylphenidate (2.5 mg/kg) or saline. Brain parts were assayed in a gamma counter, and specific striatum/cerebellum ratios were calculated for the [{sup 123}I]FP-CIT binding to DATs. No significant effects of either single intravenous, single oral or subchronic oral administration of AChEIs on striatal FP-CIT binding could be detected. Single pretreatment with methylphenidate resulted in an expected significantly lower striatal FP-CIT binding. We conclude that in rats, single intravenous and single or subchronic oral administration of the tested AChEIs does not lead to an important alteration of [{sup 123}I]FP-CIT binding to striatal DATs. Therefore, it is unlikely that these drugs will induce large effects on the interpretation of

  20. Single oral dose safety of D-allulose in dogs

    OpenAIRE

    NISHII, Naohito; NOMIZO, Toru; TAKASHIMA, Satoshi; MATSUBARA, Tatsuya; TOKUDA, Masaaki; KITAGAWA, Hitoshi

    2016-01-01

    Healthy dogs were administered acute oral doses of D-allulose (also called D-psicose) to evaluate its toxicity. Six dogs received oral doses of either a placebo or D-allulose solution (1 and 4 g/kg) on three different study days. One dog experienced vomiting, and five dogs showed transient diarrhea when 4 g/kg of D-allulose was administered. All dogs were active and had a good appetite throughout the study period. Blood glucose concentration slightly decreased without a rise in plasma insulin...

  1. Morning Sickness: Nausea and Vomiting of Pregnancy

    Science.gov (United States)

    ... Pregnancy Book Morning Sickness: Nausea and Vomiting of Pregnancy Patient Education FAQs Morning Sickness: Nausea and Vomiting of Pregnancy Patient Education Pamphlets - Spanish Morning Sickness: Nausea and Vomiting of ...

  2. Pharmacokinetics of fluralaner in dogs following a single oral or intravenous administration.

    Science.gov (United States)

    Kilp, Susanne; Ramirez, Diana; Allan, Mark J; Roepke, Rainer K A; Nuernberger, Martin C

    2014-03-07

    Fluralaner is a novel systemic insecticide and acaricide. The purpose of these studies was to investigate the pharmacokinetic properties of fluralaner in Beagle dogs following single oral or intravenous (i.v.) administration. Following the oral administration of 12.5, 25 or 50 mg fluralaner/kg body weight (BW), formulated as chewable tablets or i.v. administration of 12.5 mg fluralaner/kg BW, formulated as i.v. solution to 24 Beagles, plasma samples were collected until 112 days after treatment. Plasma concentrations of fluralaner were measured using HPLC-MS/MS. Pharmacokinetic parameters were calculated by non-compartmental methods. After oral administration, maximum plasma concentrations (C(max)) were reached within 1 day on average. Fluralaner was quantifiable in plasma for up to 112 days after single oral and i.v. treatment. The apparent half-life of fluralaner was 12-15 days and the mean residence time was 15-20 days. The apparent volume of distribution of fluralaner was 3.1 L/kg, and clearance was 0.14 L/kg/day. Fluralaner is readily absorbed after single-dose oral administration, and has a long elimination half-life, long mean residence time, relatively high apparent volume of distribution, and low clearance. These pharmacokinetic characteristics help to explain the prolonged activity of fluralaner against fleas and ticks on dogs after a single oral dose.

  3. Profiling of Oral Microbiota in Early Childhood Caries Using Single-Molecule Real-Time Sequencing

    OpenAIRE

    Yuan Wang; Jie Zhang; Xi Chen; Wen Jiang; Sa Wang; Lei Xu; Yan Tu; Pei Zheng; Ying Wang; Xiaolong Lin; Hui Chen

    2017-01-01

    Background: Alterations of oral microbiota are the main cause of the progression of caries. The goal of this study was to characterize the oral microbiota in childhood caries based on single-molecule real-time sequencing.Methods: A total of 21 preschoolers, aged 3–5 years old with severe early childhood caries, and 20 age-matched, caries-free children as controls were recruited. Saliva samples were collected, followed by DNA extraction, Pacbio sequencing, and phylogenetic analyses of the oral...

  4. Sick Sinus Syndrome After a Single Oral Administration of Garenoxacin

    Directory of Open Access Journals (Sweden)

    Chiyo Sugiyama, MD

    2010-01-01

    Full Text Available This report presents the case of a 60-year-old female who demonstrated sick sinus syndrome after a single administration of Garenoxacin (GRNX. She was administered GRNX for an upper respiratory infection and 10 minutes thereafter, she suddenly felt palpitation and numbness of both arms. She was transferred to the hospital 2 hours after taking GRNX. An electrocardiogram showed bradycardia with junctional escape beats and the longest sinus arrest was 4 seconds. She was treated with a temporary pacemaker and 21 hours after the administration of GRNX her sinus node function was observed to have completely improved. GRNX-induced sick sinus syndrome was suspected because her clinical course was compatible with the concentration of GRNX and her other cardiological assessments, including an electrophysiologic study (EPS which were conducted on the 9th day of the admission, were normal. GRNX has less effect on the QT interval than other quinolone agents. However, physicians should be aware of the risk of sick sinus syndrome because GRNX is frequently prescribed in outpatient clinics.

  5. Single intravenous and oral dose pharmacokinetics of florfenicol in the channel catfish Ictalurus punctatus

    Science.gov (United States)

    Plasma distribution and elimination of florfenicol in channel catfish were investigated after a single dose (10mg/kg) of intravenous i.v.) or oral administration in freshwater at a mean water temperature of 25.4°C. Florfenicol concentrations in plasma were analyzed by means of liquid chromatography...

  6. [Intra-oral restoration and correction of single- and multi-unit dental prostheses

    NARCIS (Netherlands)

    Roeters, F.J.M.; Loomans, B.A.C.

    2014-01-01

    In cases of a fracture of the porcelain or non-aesthetic margin of a correctly functioning single- or multi-unit dental prosthesis, an intra-oral restoration or correction using a resin composite can generally be chosen. To establish adhesion to metal, porcelain, resin and composite,

  7. COMPARATIVE METABOLISM OF ARSENIC IN MICE AFTER A SINGLE OR REPEATED ORAL ADMINISTRATION OF ARSENATE

    Science.gov (United States)

    COMPARATIVE METABOLISM OF ARSENIC IN MICE AFTER A SINGLE OR REPEATED ORAL ADMINISTRATION OF ARSENATEMichael F. Hughes*1, Elaina M. Kenyon1, Brenda C. Edwards1, Carol T. Mitchell1, Luz Maria Del Razo2 and David J. Thomas11US EPA, ORD, NHEERL, ETD, PKB, Research Triangle Pa...

  8. Concentrations of amoxicillin and clindamycin in teeth following a single dose of oral medication.

    Science.gov (United States)

    Schüssl, Yvonne; Pelz, Klaus; Kempf, Jürgen; Otten, Jörg-Elard

    2014-01-01

    The main purpose of this study is the detection of amoxicillin and clindamycin concentrations in teeth. Eleven patients received 2 g of amoxicillin, and 11 patients received 600 mg of clindamycin in a single dose of oral medication at least 60 min prior to tooth extraction due to systemic diseases. The concentrations were determined in crowns and roots separately using liquid chromatography-tandem mass spectrometry (LC-MS-MS). Amoxicillin (13 samples) and clindamycin (12 samples) were detected in the samples of the root and crown preparations of the extracted teeth. The mean concentration of amoxicillin was 0.502 μg/g in the roots and 0.171 μg/g in the crowns. The mean concentration of clindamycin was 0.270 μg/g in the roots and 0.064 μg/g in the crowns. A single dose of oral amoxicillin and clindamycin leads to concentrations of both antibiotics in teeth which exceed the minimal inhibition concentration of some oral bacteria. The proof of antibacterial activity in dental hard tissue after oral single-dose application is new. The antimicrobial effect of amoxicillin and clindamycin concentrations in roots of teeth may be of clinical relevance to bacterial reinfection from dentinal tubules.

  9. Pharmacokinetics of fluralaner in dogs following a single oral or intravenous administration

    OpenAIRE

    Kilp, Susanne; Ramirez, Diana; Allan, Mark J; Roepke, Rainer KA; Nuernberger, Martin C

    2014-01-01

    Background Fluralaner is a novel systemic insecticide and acaricide. The purpose of these studies was to investigate the pharmacokinetic properties of fluralaner in Beagle dogs following single oral or intravenous (i.v.) administration. Methods Following the oral administration of 12.5, 25 or 50 mg fluralaner/kg body weight (BW), formulated as chewable tablets or i.v. administration of 12.5 mg fluralaner/kg BW, formulated as i.v. solution to 24 Beagles, plasma samples were collected until 112...

  10. AAS 228: Day 3 morning

    Science.gov (United States)

    Kohler, Susanna

    2016-06-01

    theoretical discussion and showed that enough ionizing photons for cosmic reionization could be obtained if we consider binary stars. The idea is that material transfer within binary systems could extend the lifetimes of massive stars, thereby allowing them to produce enough ionizing photons before they die. Veronica Allen closed the session by sharing with us her work on characterizing the chemistry in the massive star-forming region G35.20-0.74N. An asymmetric distribution of nitrogen-bearing species was found, which could be due to disk fragmentation on unresolved scales and the formation of multiple sources with different ages. Plenary Session Kavli Foundation Lecture: Observation of Gravitational Waves (by Susanna Kohler)Gabriela Gonzlez, spokesperson for the LIGO Scientific collaboration.Following this mornings exciting press conference, Gabriela Gonzlez, spokesperson for the LIGO Scientific collaboration, gave the Kavli Foundation Plenary Lectureship. Though the Kavli lecture usually opens the AAS meeting, it was moved this week to accommodate the schedule for LIGOs big announcement today!Gonzlez opened the plenary by digging a little further into the physics of LIGO detections. She described how the detectors work, pointing out that theyre designed to detect a strain of 1 part in 1021. This is roughly the same as measuring if the Earth-Sun distance changed by the size of a single atom!Our ability to localize gravitational-wave detections currently relies on the timing of the observations: noting the difference in time between when the signal passes the LIGO Livingston and LIGO Hanford detectors (on the scale of 10 ms) can give us a broad sense of where in the sky the signal came from. Our ability to localize will significantly improve when future detectors like Virgo (Europe), LIGO-India, and KAGRA (Japan) come online within the next decade.Gonzalez: the addition of Virgo will significantly improve our ability to localize the sources. #aas228 pic.twitter.com/kCvG8l

  11. Morning Receptions in a Danish ECE Context

    DEFF Research Database (Denmark)

    Kornerup, Ida; Gravgaard, Mette Lykke

    This paper focus on a special pedagogical context; morning receptions as a learning environment. The studies of mornings are part of a 3 year long research project in which different types of learning environments were investigated. Few studies have researched morning receptions in this perspective...

  12. MORN5 expression during craniofacial development and its interaction with the BMP and TGFB pathways

    Directory of Open Access Journals (Sweden)

    Petra Cela

    2016-08-01

    Full Text Available MORN5 (MORN repeat containing 5 is encoded by a locus positioned on chromosome 17 in the chicken genome. The MORN motif is found in multiple copies in several proteins including junctophilins or phosphatidylinositol phosphate kinase family and the MORN proteins themselves are found across the animal and plant kingdoms. MORN5 protein has a characteristic punctate pattern in the cytoplasm in immunofluorescence imaging. Previously, MORN5 was found among differentially expressed genes in a microarray profiling experiment of the chicken embryo head. Here, we provided in situ hybridization to analyse, in detail, the MORN5 expression in chick craniofacial structures. The expression of MORN5 was first observed at stage HH17-18 (E2.5. MORN5 expression gradually appeared on either side of the primitive oral cavity, within the maxillary region. At stage HH20 (E3, prominent expression was localised in the mandibular prominences lateral to the midline. From stage HH20 up to HH29 (E6, there was strong expression in restricted regions of the maxillary and mandibular prominences. The frontonasal mass (in the midline of the face expresses MORN5, starting at HH27 (E5. The expression was concentrated in the corners or globular processes, which will ultimately fuse with the cranial edges of the maxillary prominences. MORN5 expression was maintained in the fusion zone up to stage HH29. In sections in situs, MORN5 expression was localised preferentially in the mesenchyme. We examined signals that regulate MORN5 expression in the face based on a previous microarray study. Here we validated the array results with in situ hybridization and QPCR. MORN5 was downregulated 24h after Noggin and/or RA treatment. We also determined that BMP pathway genes are downstream of MORN5 following siRNA knockdown. Based on these results, we conclude that MORN5 is both regulated by and required for BMP signalling. The restricted expression of MORN5 in the lip fusion zone shown here

  13. Single dose intravenous methyl prednisolone versus oral prednisolone in Bell's palsy: A randomized controlled trial

    Science.gov (United States)

    Giri, Prithvi; Garg, Ravindra Kumar; Singh, Maneesh Kumar; Verma, Rajesh; Malhotra, Hardeep Singh; Sharma, Praveen Kumar

    2015-01-01

    Objectives: Corticosteroids have been used in the treatment of Bell's palsy and several other postinfectious neurological conditions. We hypothesized that administration of a single dose of intravenous (IV) methylprednisolone might be an effective alternative to oral prednisolone. Materials and Methods: In this open label, randomized trial, patients with acute Bell's palsy were randomized into two groups. One group received single dose (500 mg) of IV methylprednisolone while the other group received 10 days of oral prednisone. Outcome was assessed at 1 and 3 months with House–Brackmann scale. Results: At 3 months, 93 (79.48%) patients had completely recovered. IV methylprednisolone and oral prednisolone groups had similar recovery rates (80% vs. 78.33%, P > 0.05). Patients with Grade 2 and 3 recovered completely. In patients with Grade 6, the recovery rate was 20%. A better outcome was observed if corticosteroids were administered within 3 days of onset of palsy. Conclusion: Intravenous methylprednisolone and oral prednisolone showed equivalent benefit in patients with acute Bell's palsy. PMID:25878371

  14. Pharmacokinetics of terbinafine after oral administration of a single dose to Hispaniolan Amazon parrots (Amazona ventralis).

    Science.gov (United States)

    Evans, Erika E; Emery, Lee C; Cox, Sherry K; Souza, Marcy J

    2013-06-01

    To determine pharmacokinetics after oral administration of a single dose of terbinafine hydrochloride to Hispaniolan Amazon parrots (Amazona ventralis). 6 healthy adult Hispaniolan Amazon parrots. A single dose of terbinafine hydrochloride (60 mg/kg) was administered orally to each bird, which was followed immediately by administration of a commercially available gavage feeding formula. Blood samples were collected at the time of drug administration (time 0) and 0.25, 0.5, 1, 2, 4, 8, 12, and 24 hours after drug administration. Plasma concentrations of terbinafine were determined via high-performance liquid chromatography. Data from 1 bird were discarded because of a possible error in the dose of drug administered. After oral administration of terbinafine, the maximum concentration for the remaining 5 fed birds ranged from 109 to 671 ng/mL, half-life ranged from 6 to 13.5 hours, and time to the maximum concentration ranged from 2 to 8 hours. No adverse effects were observed. Analysis of the results indicated that oral administration of terbinafine at a dose of 60 mg/kg to Amazon parrots did not result in adverse effects and may be potentially of use in the treatment of aspergillosis. Additional studies are needed to determine treatment efficacy and safety.

  15. Single intravenous and oral dose pharmacokinetics of florfenicol in the channel catfish (Ictalurus punctatus).

    Science.gov (United States)

    Gaunt, P S; Langston, C; Wrzesinski, C; Gao, D; Adams, P; Crouch, L; Sweeney, D; Endris, R

    2012-10-01

    Plasma distribution and elimination of florfenicol in channel catfish were investigated after a single dose (10 mg/kg) of intravenous (i.v.) or oral administration in freshwater at a mean water temperature of 25.4 °C. Florfenicol concentrations in plasma were analyzed by means of liquid chromatography with MS/MS detection. After i.v. florfenicol injection, the terminal half-life (t(1/2)), volume of distribution at steady state (V(ss)), and central volume of distribution (V(c)) were 8.25 h, 0.9 and 0.381 L/kg, respectively. After oral administration of florfenicol, the terminal t(1/2), C(max), T(max), and oral bioavailability (F) were 9.11 h, 7.6 μg/mL, 9.2 h, and 1.09, respectively. There was a lag absorption time of 1.67 h in oral dosing. Results from these studies support that 10 mg florfenicol/kg body weight in channel catfish is an efficacious dosage following oral administration. © 2011 Blackwell Publishing Ltd.

  16. Profiling of Oral Microbiota in Early Childhood Caries Using Single-Molecule Real-Time Sequencing.

    Science.gov (United States)

    Wang, Yuan; Zhang, Jie; Chen, Xi; Jiang, Wen; Wang, Sa; Xu, Lei; Tu, Yan; Zheng, Pei; Wang, Ying; Lin, Xiaolong; Chen, Hui

    2017-01-01

    Background: Alterations of oral microbiota are the main cause of the progression of caries. The goal of this study was to characterize the oral microbiota in childhood caries based on single-molecule real-time sequencing. Methods: A total of 21 preschoolers, aged 3-5 years old with severe early childhood caries, and 20 age-matched, caries-free children as controls were recruited. Saliva samples were collected, followed by DNA extraction, Pacbio sequencing, and phylogenetic analyses of the oral microbial communities. Results: Eight hundred and seventy six species derived from 13 known bacterial phyla and 110 genera were detected from 41 children using Pacbio sequencing. At the species level, 38 species, including Veillonella spp., Streptococcus spp., Prevotella spp., and Lactobacillus spp., showed higher abundance in the caries group compared to the caries-free group ( p free micro-ecological niche. At follow-up, oral examinations 6 months after sample collection, development of new dental caries was observed in 5 children (the transitional group) among the 21 caries free children. Compared with the caries-free children, in the transitional and caries groups, 6 species, which were more abundant in the caries-free group, exhibited a relatively low abundance in both the caries group and the transitional group ( p < 0.05). We conclude that Abiotrophia spp., Neisseria spp., and Veillonella spp., might be associated with healthy oral microbial ecosystem. Prevotella spp., Lactobacillus spp., Dialister spp., and Filifactor spp. may be related to the pathogenesis and progression of dental caries.

  17. Socialization at the morning meeting

    DEFF Research Database (Denmark)

    Rimestad, Lene; Gravengaard, Gitte

    2016-01-01

    In this ethnographic study we examine how journalism interns present ideas at morning meetings in the professional environment of a media organization. We analyse not only the idea presentation at the meeting itself, but also how editors treat the idea presentation, and how the interns perceive...... the situation of presenting idea. We discuss the implications for innovation and creativity in the newsroom. The aim of the research is to gain insight into the socialization of journalism students in order to discuss and improve the academic and craft education of the students....

  18. Fluralaner as a single dose oral treatment for Caparinia tripilis in a pygmy African hedgehog.

    Science.gov (United States)

    Romero, Camilo; Sheinberg Waisburd, Galia; Pineda, Jocelyn; Heredia, Rafael; Yarto, Enrique; Cordero, Alberto M

    2017-12-01

    African pygmy hedgehogs (Atelerix albiventris) are popular pets belonging to the Erinaceidae family of spined mammals. Amongst the most common skin diseases occurring in this species is infestation caused by the mite Caparinia spp. Due to their skin anatomy and spiny coat, detection of skin lesions in these hedgehogs can be difficult. This may result in delays in seeking medical care, which may lead to secondary bacterial infection and self-inflicted trauma. Multiple therapies have been used in the treatment of this skin condition including ivermectin, amitraz, fipronil and selamectin. A drug which could be administered as a single oral dose would be advantageous to these pets and their owners. To evaluate the effect of a single oral dose (15 mg/kg) of fluralaner on Caparinia tripilis infestation in the African pygmy hedgehog. A 10-month-old African pygmy hedgehog weighing 184 g. Response to treatment was monitored by dermatological examination and superficial skin scrapings repeated at 7, 14, 21, 30, 60, 90 and 120 days following fluralaner administration. On Day 7 after treatment, adult mites were observed exhibiting normal movement. On Day 14, only dead mites were observed. No life stages of the mites were found after Day 21. A single oral dose at 15 mg/kg of fluralaner was effective within 21 days after treatment for capariniasis in this case. Further studies are required to evaluate the drug's safety and toxicology in hedgehogs, and to confirm efficacy. © 2017 ESVD and ACVD.

  19. Oral microflora and selection of resistance after a single dose of amoxicillin.

    Science.gov (United States)

    Khalil, D; Hultin, M; Rashid, M U; Lund, B

    2016-11-01

    The study aimed to determine the effects of a single-dose antibiotic prophylaxis on normal oral microflora. A single dose of 2 g amoxicillin was given to 29 healthy volunteers. Saliva was collected before antibiotic administration (day 1), and again on days 2, 5, 10, 17 and 24 and subjected to culturing and antibiotic sensitivity analysis. Twenty-one per cent (6/29) of the individuals carried penicillin-V- and amoxicillin-resistant viridans streptococci before antibiotic administration. After a single dose of amoxicillin there was a significant reduction in Streptococcus salivarius on days 2 and 5, a significant reduction in other viridans streptococci on day 2 and the proportion of viridans streptococci with reduced susceptibility to amoxicillin was significantly increased on days 2 and 5. A single dose of amoxicillin can cause an ecological disturbance and induce selection of resistant strains in the oral microflora. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  20. Effect of single oral dose of tramadol on gastric secretions pH

    Directory of Open Access Journals (Sweden)

    Khan Mueen Ullah

    2015-01-01

    Full Text Available Background: Tramadol is an atypical analgesic agent. It has been shown that intramuscular or intravenous injection tramadol is able to inhibit M3 muscarinic receptors. Tramadol is able to mediate smooth muscles contraction and glandular secretions. We have evaluated the effects of single oral dose of tramadol given preoperatively on gastric juices pH in patients electively scheduled for laparoscopic cholecystectomy. Materials and Methods: Sixty adult, American Society of Anesthesiologist I and II patients scheduled for laparoscopic cholecystectomy were included in the study. Patients were randomly assigned to receive either placebo (n = 30 or oral tramadol 50 mg (n = 30. General anesthesia was induced using propofol, fentanyl and cisatracurium. After induction of anesthesia 5 ml of gastric fluid was aspirated through orogastric tube. The gastric fluid pH was measured using pH meter. Result: There was no significant difference in the pH between the groups. Gastric pH of the placebo and tramadol groups was 1.97 versus 1.98 (P = 0.092 respectively. Conclusion: Preoperatively single oral dose of tramadol was unable to elevate the desired level of gastric acid secretions pH (>2.5. This may be due to pharmacokinetic disparity between the analgesic and pH elevating properties of tramadol.

  1. Pharmacokinetic study of single and multiple oral administrations of 2 mg dienogest in healthy Korean women.

    Science.gov (United States)

    Shin, Donghoon; Lee, SeungHwan; Lim, Kyoung Soo; Park, Joong Shin; Shin, Sang-Goo; Jang, In-Jin; Yu, Kyung-Sang

    2013-06-01

    The progestin dienogest was developed for oral contraception, endometriosis treatment and menopause management. Dienogest's pharmacokinetics have been primarily studied in Caucasian women. This study evaluated the single- and multiple-dose pharmacokinetics of dienogest in Korean women. Sixteen healthy Korean adult women received a single administration of 2 mg dienogest, followed by multiple once-daily administrations for 14 days. The single-dose administration and the final dose of the multiple administrations were each followed by blood sampling over 60 h. The mean (SD) maximum serum concentration after multiple doses of dienogest was slightly increased compared with that after a single dose [from 51.6 (9.6) to 56.6 (11.9) ng/mL], as was the area under the concentration-time curves (AUC)0-24h [from 503 (56.3) to 613 (90.7) ng ∙ h/mL]. The linearity factor calculated by AUCs of single and multiple doses is 1.00 ± 0.14, and the terminal half-life remained unchanged when single dosing and multiple dosing were compared. The present study described the single- and multiple-dose pharmacokinetic profiles of dienogest in Korean women and showed linear pharmacokinetics of dienogest at steady state. Copyright © 2013 Elsevier Inc. All rights reserved.

  2. Protective effects of orally applied fullerenol nano particles in rats after a single dose of doxorubicin

    Directory of Open Access Journals (Sweden)

    Ičević Ivana Đ.

    2011-01-01

    Full Text Available Polyhydroxylated, water soluble, fullerenol C60(OH24 nano particles (FNP in vitro and in vivo models, showed an expressive biological activity. The goal of this work was to investigate the potential protective effects of orally applied FNP on rats after a single dose of doxorubicin (DOX (8 mg/kg (i.p. 6 h after the last application of FNP. After the last drug administration, the rats were sacrificed, and the blood and tissues were taken for the analysis. Biochemical and pathological results obtained in this study indicate that fullerenol (FNP, in H2O:DMSO (80:20, w/w solution given orally in final doses of 10, 14.4, and 21.2 mg/kg three days successively, has the protective (hepatoprotective and nephroprotective effect against doxorubicin-induced cytotoxicity via its antioxidant properties.

  3. Profiling of Oral Microbiota in Early Childhood Caries Using Single-Molecule Real-Time Sequencing

    Directory of Open Access Journals (Sweden)

    Yuan Wang

    2017-11-01

    Full Text Available Background: Alterations of oral microbiota are the main cause of the progression of caries. The goal of this study was to characterize the oral microbiota in childhood caries based on single-molecule real-time sequencing.Methods: A total of 21 preschoolers, aged 3–5 years old with severe early childhood caries, and 20 age-matched, caries-free children as controls were recruited. Saliva samples were collected, followed by DNA extraction, Pacbio sequencing, and phylogenetic analyses of the oral microbial communities.Results: Eight hundred and seventy six species derived from 13 known bacterial phyla and 110 genera were detected from 41 children using Pacbio sequencing. At the species level, 38 species, including Veillonella spp., Streptococcus spp., Prevotella spp., and Lactobacillus spp., showed higher abundance in the caries group compared to the caries-free group (p < 0.05. The core microbiota at the genus and species levels was more stable in the caries-free micro-ecological niche. At follow-up, oral examinations 6 months after sample collection, development of new dental caries was observed in 5 children (the transitional group among the 21 caries free children. Compared with the caries-free children, in the transitional and caries groups, 6 species, which were more abundant in the caries-free group, exhibited a relatively low abundance in both the caries group and the transitional group (p < 0.05. We conclude that Abiotrophia spp., Neisseria spp., and Veillonella spp., might be associated with healthy oral microbial ecosystem. Prevotella spp., Lactobacillus spp., Dialister spp., and Filifactor spp. may be related to the pathogenesis and progression of dental caries.

  4. A Compartmental Analysis for Morphine and Its Metabolites in Young Children After a Single Oral Dose.

    Science.gov (United States)

    Velez de Mendizabal, Nieves; Jimenez-Mendez, Ricardo; Cooke, Erin; Montgomery, Carolyne J; Dawes, Joy; Rieder, Michael J; Aleksa, Katarina; Koren, Gideon; Jacobo-Cabral, Carlos O; Gonzalez-Ramirez, Rodrigo; Castañeda-Hernandez, Gilberto; Carleton, Bruce C

    2015-10-01

    Currently, the majority of the surgical procedures performed in paediatric hospitals are done on a day care basis, with post-operative pain being managed by caregivers at home. Pain after discharge of these post-operative children has historically been managed with oral codeine in combination with paracetamol (acetaminophen). Codeine is an opioid, which elicits its analgesic effects via metabolism to morphine and codeine-6-glucuronide. Oral morphine is a feasible alternative for outpatient analgesia; however, the pharmacokinetics of morphine after oral administration have been previously described only sparsely, and there is little information in healthy children. The clinical trial included 40 children from 2 to 6 years of age, with an American Society of Anaesthesiologists physical status classification of 1 or 2, who were undergoing surgical procedures requiring opioid analgesia. Morphine was orally administered prior to surgery in one of three doses: 0.1 mg/kg, 0.2 mg/kg and 0.3 mg/kg. Blood samples were collected for plasma morphine, morphine-3-glucuronide (M3G) and morphine-6-glucuronide (M6G) concentrations at 30, 60, 90, 120, 180 and 240 min after administration. All analyses were performed with the non-linear mixed-effect modelling software NONMEM version 7.2, using the first-order conditional estimation (FOCE) method. A pharmacokinetic model was developed to simultaneously describe the plasma profiles of morphine and its metabolites M3G and M6G after a single dose of oral morphine in young children (2-6 years of age). The disposition of morphine, M3G and M6G in plasma was best described by a one-compartment model. M3G and M6G metabolite formation was best described by a delay transit compartment, indicating a delay in the appearance of these two major metabolites. This model provides a foundation on which to further evaluate the use of oral morphine and its safety in young children. Longer follow-up time for morphine oral doses and incorporation of

  5. Implementation research: reactive mass vaccination with single-dose oral cholera vaccine, Zambia.

    Science.gov (United States)

    Poncin, Marc; Zulu, Gideon; Voute, Caroline; Ferreras, Eva; Muleya, Clara Mbwili; Malama, Kennedy; Pezzoli, Lorenzo; Mufunda, Jacob; Robert, Hugues; Uzzeni, Florent; Luquero, Francisco J; Chizema, Elizabeth; Ciglenecki, Iza

    2018-02-01

    To describe the implementation and feasibility of an innovative mass vaccination strategy - based on single-dose oral cholera vaccine - to curb a cholera epidemic in a large urban setting. In April 2016, in the early stages of a cholera outbreak in Lusaka, Zambia, the health ministry collaborated with Médecins Sans Frontières and the World Health Organization in organizing a mass vaccination campaign, based on single-dose oral cholera vaccine. Over a period of 17 days, partners mobilized 1700 health ministry staff and community volunteers for community sensitization, social mobilization and vaccination activities in 10 townships. On each day, doses of vaccine were delivered to vaccination sites and administrative coverage was estimated. Overall, vaccination teams administered 424 100 doses of vaccine to an estimated target population of 578 043, resulting in an estimated administrative coverage of 73.4%. After the campaign, few cholera cases were reported and there was no evidence of the disease spreading within the vaccinated areas. The total cost of the campaign - 2.31 United States dollars (US$) per dose - included the relatively low cost of local delivery - US$ 0.41 per dose. We found that an early and large-scale targeted reactive campaign using a single-dose oral vaccine, organized in response to a cholera epidemic within a large city, to be feasible and appeared effective. While cholera vaccines remain in short supply, the maximization of the number of vaccines in response to a cholera epidemic, by the use of just one dose per member of an at-risk community, should be considered.

  6. Single-dose oral naproxen for acute postoperative pain: a quantitative systematic review

    Directory of Open Access Journals (Sweden)

    Moore R Andrew

    2003-09-01

    Full Text Available Abstract Background Naproxen and naproxen sodium are non-steroidal anti-inflammatory drugs used in a variety of painful conditions, including the treatment of postoperative pain. This review aims to assess the efficacy, safety and duration of action of a single oral dose of naproxen/naproxen sodium for moderate to severe acute postoperative pain in adults, compared with placebo. Methods The Cochrane Library (issue 4 2002, EMBASE, PubMed, MEDLINE and an in-house database were searched for randomised, double blind, placebo controlled trials of a single dose of orally administered naproxen or naproxen sodium in adults with acute postoperative pain. Pain relief or pain intensity data were extracted and converted into dichotomous information to give the number of patients with at least 50% pain relief over 4 to 6 hours. Relative benefit and number-needed-to-treat were then calculated. The percentage of patients with any adverse event, number-needed-to-harm, and time to remedication were also calculated. Results Ten trials with 996 patients in met the inclusion criteria. Six trials compared naproxen sodium 550 mg (252 patients with placebo (248 patients; the NNT for at least 50% pain relief over six hours was 2.6 (95% confidence interval 2.2 to 3.2. There was no significant difference between the number of patients experiencing any adverse event on treatment compared with placebo. Weighted mean time to remedication was 7.6 hours for naproxen sodium 550 mg (206 patients and 2.6 hours for placebo (205 patients. Four other trials used lower doses. Conclusion A single oral dose of naproxen sodium 550 mg is an effective analgesic in the treatment of acute postoperative pain. A low incidence of adverse events was found, although these were not reported consistently.

  7. oral

    African Journals Online (AJOL)

    Chlorhexidine 0,2% gluconate is used as a mouth rinse and is an effective antibacterial agent. Its primary side- effects are staining of the teeth and the oral mucosa, particularly the dorsal surface of the tongue. However, this is transient. It has been shown to be effective as a prophylactic agent in preventing oral candidosis in ...

  8. Safety and pharmacokinetics of dicloxacillin in healthy Chinese volunteers following single and multiple oral doses

    Directory of Open Access Journals (Sweden)

    Wu GL

    2015-10-01

    Full Text Available Guolan Wu, Yunliang Zheng, Huili Zhou, Xingjiang Hu, Jian Liu, You Zhai, Meixiang Zhu, Lihua Wu, Jianzhong Shentu Research Center for Clinical Pharmacy, State Key Laboratory for Diagnosis and Treatment of Infectious Disease, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People’s Republic of China Background: Dicloxacillin, a semisynthetic isoxazolyl penicillin antibiotic, has antimicrobial activity against a wide variety of gram-positive bacteria including Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumonia, Streptococcus epidermidis, Streptococcus viridans, Streptococcus agalactiae, and Neisseria meningitidis. The objective of this study was to evaluate the safety and pharmacokinetic profile of dicloxacillin after single and multiple oral dose in healthy Chinese volunteers.Methods: A single-center, open-label, randomized, two-phase study was conducted in 16 subjects. In the single-dose phase, subjects were randomly assigned to receive single doses of 0.25, 0.5, 1.0, and 2.0 g of dicloxacillin sodium capsule in a 4-way crossover design with a 5-day washout period between administrations. In the multiple-dose phase, subjects were assigned to receive 0.25 or 0.5 g every 6 hours for 3 days in a 2-way crossover design. Plasma and urine pharmacokinetic samples were assayed by a validated high-performance liquid chromatography-tandem mass spectrometry method. Pharmacokinetic parameters were calculated and analyzed statistically. Safety assessments were conducted throughout the study.Results: Following a single oral dose of 0.25–2.0 g dicloxacillin sodium, the maximum plasma drug concentration (Cmax and the corresponding values for the area under the concentration–time curve from 0 to 10 hours (AUC0–10 h increased in a dose-proportional manner. The mean elimination half-life (t1/2 was in the range of 1.38–1.71 hours. Dicloxacillin was excreted in its unchanged form via the kidney, with no

  9. Single nucleotide polymorphism barcoding to evaluate oral cancer risk using odds ratio-based genetic algorithms

    Directory of Open Access Journals (Sweden)

    Cheng-Hong Yang

    2012-07-01

    Full Text Available Cancers often involve the synergistic effects of gene–gene interactions, but identifying these interactions remains challenging. Here, we present an odds ratio-based genetic algorithm (OR-GA that is able to solve the problems associated with the simultaneous analysis of multiple independent single nucleotide polymorphisms (SNPs that are associated with oral cancer. The SNP interactions between four SNPs—namely rs1799782, rs2040639, rs861539, rs2075685, and belonging to four genes (XRCC1, XRCC2, XRCC3, and XRCC4—were tested in this study, respectively. The GA decomposes the SNPs sets into different SNP combinations with their corresponding genotypes (called SNP barcodes. The GA can effectively identify a specific SNP barcode that has an optimized fitness value and uses this to calculate the difference between the case and control groups. The SNP barcodes with a low fitness value are naturally removed from the population. Using two to four SNPs, the best SNP barcodes with maximum differences in occurrence between the case and control groups were generated by GA algorithm. Subsequently, the OR provides a quantitative measure of the multiple SNP synergies between the oral cancer and control groups by calculating the risk related to the best SNP barcodes and others. When these were compared to their corresponding non-SNP barcodes, the estimated ORs for oral cancer were found to be great than 1 [approx. 1.72–2.23; confidence intervals (CIs: 0.94–5.30, p < 0.03–0.07] for various specific SNP barcodes with two to four SNPs. In conclusion, the proposed OR-GA method successfully generates SNP barcodes, which allow oral cancer risk to be evaluated and in the process the OR-GA method identifies possible SNP–SNP interactions.

  10. PHARMACOKINETICS OF ORALLY ADMINISTERED VORICONAZOLE IN AFRICAN PENGUINS (SPHENISCUS DEMERSUS) AFTER SINGLE AND MULTIPLE DOSES.

    Science.gov (United States)

    Hyatt, Michael W; Wiederhold, Nathan P; Hope, William W; Stott, Katharine E

    2017-06-01

    Aspergillosis is a common respiratory fungal disease in African penguins ( Spheniscus demersus ) under managed care, and treatment failures with itraconazole due to drug resistance are increasingly common, leading to recent use of voriconazole. Empirical dosing with voriconazole based on other avian studies has resulted in adverse clinical drug effects in penguins. The objective of this study was to determine oral voriconazole pharmacokinetics (PK) in African penguins (n = 18). Single and once daily multiple oral doses of 5 mg/kg voriconazole were evaluated with a 4-mo washout period between trials. Plasma voriconazole concentrations were determined via high-performance liquid chromatography. Data was modeled using 3-compartamental population methodologies that supported first-order elimination. Observed mean peak concentration (1.89 μg/ml) after single dosing PK analysis was determined within the first hour following voriconazole administration. In the multiple-dose trial average plasma voriconazole concentrations were significantly higher on days 4 and 7 as compared with day 2. The mean estimates for volume of distribution (V/F) and clearance (Cl/F) for the multiple-dose study were 3.34 L and 0.18 L/hr, respectively. Monte Carlo simulations determined the median area under the curve (AUC 0-24 ) at 84 hr was 37.7 μg·h/ml. As this assessment was comparable with the average AUC in humans receiving the recommended human oral dosage 200 mg b.i.d., it suggests that 5 mg/kg p.o. s.i.d. could be a safe and effective regimen in African penguins for treatment of aspergillosis. However, due to potential drug accumulation and subsequent toxicity, therapeutic drug monitoring with dosage adjustments is recommended to individualize dosing.

  11. Successful comeback of the single-dose live oral cholera vaccine CVD 103-HgR.

    Science.gov (United States)

    Herzog, Christian

    2016-01-01

    Effective and easy to administer cholera vaccines are in need more than ever, for at risk populations and travellers alike. In many parts of the world cholera is still endemic, causing outbreaks and constituting repeatedly serious public health problems. The oral live cholera vaccine CVD 103-HgR (Orochol, Mutachol), the first genetically modified organism (GMO) used as vaccine, was in its time (launched 1993, Switzerland) the ideal cholera vaccine: single-dose, protective efficacy of 80-100% against moderate to severe cholera, acting within 8 days and exhibiting excellent safety, indiscernible from placebo. However, there were strong headwinds: In the 1990s the indication for cholera vaccines was generally downplayed by experts and in 1997 the European Commission called for a moratorium of GMOs which blocked the registration in the European Union. Thus, demand for this vaccine remained low and in 2003 it was taken off the market for economic reasons. After a decade in obscurity it (Vaxchora) has resurfaced again, now produced in the U.S. and equipped with a U.S. FDA license (June 10, 2016). What had happened? This commentary gives a critical account of an almost unbelievable string of misadventures, emerging adverse circumstances and man-made failures which nearly killed this single-dose live oral cholera vaccine. The good news is that patience and persistence lead to success in the end, allowing good science to prevail for the benefit of those in need. Copyright © 2016 Elsevier Ltd. All rights reserved.

  12. Brain clocks for morning and evening behaviour

    Indian Academy of Sciences (India)

    Unknown

    Different subgroups of cells that regu- late the morning and evening components of activity are ... tion of time from circadian pacemaker to target organs? At least two decades ago, a model of circadian clocks .... type behaviour (with robust morning and evening bouts of activity) by expressing UAS-per in the CRY+ cells.

  13. Complete Protection against Pneumonic and Bubonic Plague after a Single Oral Vaccination.

    Directory of Open Access Journals (Sweden)

    Anne Derbise

    Full Text Available No efficient vaccine against plague is currently available. We previously showed that a genetically attenuated Yersinia pseudotuberculosis producing the Yersinia pestis F1 antigen was an efficient live oral vaccine against pneumonic plague. This candidate vaccine however failed to confer full protection against bubonic plague and did not produce F1 stably.The caf operon encoding F1 was inserted into the chromosome of a genetically attenuated Y. pseudotuberculosis, yielding the VTnF1 strain, which stably produced the F1 capsule. Given orally to mice, VTnF1 persisted two weeks in the mouse gut and induced a high humoral response targeting both F1 and other Y. pestis antigens. The strong cellular response elicited was directed mostly against targets other than F1, but also against F1. It involved cells with a Th1-Th17 effector profile, producing IFNγ, IL-17, and IL-10. A single oral dose (108 CFU of VTnF1 conferred 100% protection against pneumonic plague using a high-dose challenge (3,300 LD50 caused by the fully virulent Y. pestis CO92. Moreover, vaccination protected 100% of mice from bubonic plague caused by a challenge with 100 LD50 Y. pestis and 93% against a high-dose infection (10,000 LD50. Protection involved fast-acting mechanisms controlling Y. pestis spread out of the injection site, and the protection provided was long-lasting, with 93% and 50% of mice surviving bubonic and pneumonic plague respectively, six months after vaccination. Vaccinated mice also survived bubonic and pneumonic plague caused by a high-dose of non-encapsulated (F1- Y. pestis.VTnF1 is an easy-to-produce, genetically stable plague vaccine candidate, providing a highly efficient and long-lasting protection against both bubonic and pneumonic plague caused by wild type or un-encapsulated (F1-negative Y. pestis. To our knowledge, VTnF1 is the only plague vaccine ever reported that could provide high and durable protection against the two forms of plague after a single

  14. Single dose oral ranitidine improves MRCP image quality: a double-blind study

    Energy Technology Data Exchange (ETDEWEB)

    Bowes, M.T. [South Manchester University Hospitals NHS Trust, Wythenshawe, Manchester (United Kingdom); Martin, D.F. [South Manchester University Hospitals NHS Trust, Wythenshawe, Manchester (United Kingdom)]. E-mail: derrick.martin@smtr.nhs.uk; Melling, A. [South Manchester University Hospitals NHS Trust, Wythenshawe, Manchester (United Kingdom); Roberts, D. [South Manchester University Hospitals NHS Trust, Wythenshawe, Manchester (United Kingdom); Laasch, H.-U. [South Manchester University Hospitals NHS Trust, Wythenshawe, Manchester (United Kingdom); Sukumar, S. [South Manchester University Hospitals NHS Trust, Wythenshawe, Manchester (United Kingdom); Morris, J. [South Manchester University Hospitals NHS Trust, Wythenshawe, Manchester (United Kingdom)

    2007-01-15

    Aim: To investigate the possibility of whether a single 300 mg dose of ranitidine given orally 2-3 h before magnetic resonance cholangiopancreatography (MRCP) could reduce the signal from the stomach and duodenum, and thus increase the conspicuousness of the biliary tree. Materials and methods: Thirty-five volunteers (22 female, 13 male), (age range 21-50) were underwent MRCP in a double-blind, placebo-controlled, randomized, crossover trial on a Philips Intera 1.5 T machine using a phased array surface coil. Imaging was carried out in the coronal oblique plane. Six 40 mm sections were acquired at varying angles to delineate the biliary tree and pancreatic duct. The 70 examinations were blindly scored by three consultants experienced in cholangiography. Results: After ranitidine administration there was a significant decrease in signal from the stomach (mean = 17.7, p = 0.0005, CI 10, 25.3) and duodenum (mean = 18.4, p = 0.0005, 95%CI 9.6, 27.1) with a significant increase in conspicuousness of the distal common duct (mean = 7.7, p = 0.033, 95%CI 0.7, 14.7) and proximal common duct (mean = 8.7, p = 0.010 CI 2.2, 15.2). There were no adverse effects. Conclusion: Oral ranitidine is a cheap and effective agent to decrease signal from the upper gastrointestinal tract and to improve visibility of the biliary tree.

  15. Single dose oral ranitidine improves MRCP image quality: a double-blind study

    International Nuclear Information System (INIS)

    Bowes, M.T.; Martin, D.F.; Melling, A.; Roberts, D.; Laasch, H.-U.; Sukumar, S.; Morris, J.

    2007-01-01

    Aim: To investigate the possibility of whether a single 300 mg dose of ranitidine given orally 2-3 h before magnetic resonance cholangiopancreatography (MRCP) could reduce the signal from the stomach and duodenum, and thus increase the conspicuousness of the biliary tree. Materials and methods: Thirty-five volunteers (22 female, 13 male), (age range 21-50) were underwent MRCP in a double-blind, placebo-controlled, randomized, crossover trial on a Philips Intera 1.5 T machine using a phased array surface coil. Imaging was carried out in the coronal oblique plane. Six 40 mm sections were acquired at varying angles to delineate the biliary tree and pancreatic duct. The 70 examinations were blindly scored by three consultants experienced in cholangiography. Results: After ranitidine administration there was a significant decrease in signal from the stomach (mean = 17.7, p = 0.0005, CI 10, 25.3) and duodenum (mean = 18.4, p = 0.0005, 95%CI 9.6, 27.1) with a significant increase in conspicuousness of the distal common duct (mean = 7.7, p = 0.033, 95%CI 0.7, 14.7) and proximal common duct (mean = 8.7, p = 0.010 CI 2.2, 15.2). There were no adverse effects. Conclusion: Oral ranitidine is a cheap and effective agent to decrease signal from the upper gastrointestinal tract and to improve visibility of the biliary tree

  16. Blockade of leukotriene production by a single oral dose of MK-0591 in active ulcerative colitis

    DEFF Research Database (Denmark)

    Hillingsø, Jens; Kjeldsen, J; Laursen, L S

    1995-01-01

    -ethyl)thio)-5(quinolin+ ++-2ylmethyl-oxy)-1H-indol-2yl)-2,2-dimethyl-propanoate) exerts its effect by binding to the 5-lipoxygenase activating protein, thereby inhibiting the translocation and activation of 5-lipoxygenase. METHODS: Concentrations of leukotriene B4 (LTB4) and prostaglandin E2 (PGE2) in rectal...... that a single oral 250 mg dose of MK-0591 results in nearly complete blockade of systemic leukotriene production and LTB4 formation in the target tissue of inflammation (the rectum). Controlled multiple-dose trials to assess the clinical efficacy of this novel 5-lipoxygenase-activating protein inhibitor seem......BACKGROUND: 5-Lipoxygenase products of arachidonic acid metabolism are thought to play a central role in the secondary amplification of the inflammatory response in a number of human inflammatory diseases, such as ulcerative colitis. MK-0591 (3-(1((4-chlorophenyl)methyl)-3((1,1-dimethyl...

  17. Chemoprophylaxis of coccidiosis in lambs with a single oral dose of toltrazuril.

    Science.gov (United States)

    Gjerde, B; Helle, O

    1991-03-01

    The prophylactic efficacy of a single oral dose of toltrazuril against coccidiosis (mixed Eimeria infections) in naturally infected lambs was evaluated in two experiments. Toltrazuril at 20 mg kg-1, given on Day 7 or Day 10 after turnout on pasture, proved to be highly efficacious in preventing clinical coccidiosis under Norwegian conditions. Toltrazuril reduced the oocyst output to very low levels, prevented the development of diarrhoea and improved weight gain during the first 4-5 weeks after treatment. Treatment on Day 7 was superior to treatment on Day 10 with respect to improving weight gain and preventing the development of soft faeces. Lambs treated with toltrazuril on Day 7 seemed to be as immune as untreated lambs to natural reinfections with coccidia later in the grazing season. In one of the experiments, natural infections with the nematode Nematodirus battus produced a coccidiosis-like disease in some lambs simultaneously with the outbreak of coccidiosis.

  18. Prospective single blinded randomised controlled trial of two orally administered activated charcoal preparations.

    Science.gov (United States)

    Boyd, R; Hanson, J

    1999-01-01

    OBJECTIVES: To compare two activated charcoal preparations (Carbomix and Actidose-Aqua) in terms of amount ingested and incidence of vomiting after ingestion. METHODS: Single blinded prospective randomised controlled trial. RESULTS: The mean amount of charcoal ingested was Carbomix 26.5 g, Actidose-Aqua 19.5 g. The mean difference was 7 g (95% confidence interval (CI) 1.5 to 12.4 g). The incidence of vomiting was for the Carbomix 6% and the Actidose-Aqua 8%. The mean difference in vomiting was 2% (95% CI -0.8 to 4.8) CONCLUSIONS: Carbomix administration results in an increased amount of activated charcoal ingested after oral administration. Rates of vomiting after activated charcoal administration were low when compared with previously reported rates. PMID:9918281

  19. Alteration of the systemic and microcirculation by a single oral dose of flavan-3-ols.

    Directory of Open Access Journals (Sweden)

    Kodai Ingawa

    Full Text Available Several systematic reviews have reported that flow mediated dilatation (FMD was significantly increased in subjects after ingestion of chocolate that contains flavan-3-ols; however, the mechanisms responsible for this effect are not clear. In this study, we evaluated the effects of a single oral dose of flavan-3-ols on the systemic circulation and microcirculation in the cremaster muscle using intravital video microscopy in vivo. The cremaster muscle in rats was spread over a plastic chamber and a gastric tube was placed into the stomach. Blood flow in the cremasteric artery was determined using a laser Doppler flowmeter, while blood pressure and heart rate were measured by the tail-cuff method. Red blood cell velocity in arterioles and blood flow in the artery were significantly increased 5 min after the administration of 10 mg/kg flavan-3-ols compared with distilled water treatment. The number of capillaries recruited in the cremaster muscle was also significantly increased 15 min after treatment. Microscopic observation confirmed that increased shear stress on endothelial cells was maintained during the measurement period. The mean arterial blood pressure and heart rate were also significantly elevated soon after administration and returned to baseline before the end of the observation period. Plasma nitrate and nitrite levels, and NO phosphorylation of aortic tissue were significantly increased at 60 min after administration of flavan-3-ols. According to these results, a single oral dose of flavan-3-ols elevates blood pressure and flow transiently, and these effects induce NO production through increased shear stress on endothelial cells.

  20. Single fixed-dose oral dexketoprofen plus tramadol for acute postoperative pain in adults.

    Science.gov (United States)

    Derry, Sheena; Cooper, Tess E; Phillips, Tudor

    2016-09-22

    Combining two different analgesics in fixed doses in a single tablet can provide better pain relief than either drug alone in acute pain. This appears to be broadly true across a range of different drug combinations, in postoperative pain and migraine headache. A new combination of dexketoprofen (a nonsteroidal anti-inflammatory drug) plus tramadol (an opioid) has been tested in acute postoperative pain conditions. It is not yet licensed for use. This review is one of a series on oral analgesics for acute postoperative pain. Individual reviews have been brought together in two overviews to provide information about the relative efficacy and harm of the different interventions. To assess the analgesic efficacy and adverse effects of a single fixed-dose of oral dexketoprofen plus tramadol, compared with placebo, for moderate to severe postoperative pain in adults, using methods that permit comparison with other analgesics evaluated in standardised trials using almost identical methods and outcomes. A secondary objective was to compare the combination with the individual analgesics alone. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) via CRSO, MEDLINE via Ovid, and Embase via Ovid from inception to 31 May 2016. We also searched the reference lists of retrieved studies and reviews, and two online clinical trial registries. Randomised, double-blind trials of oral dexketoprofen plus tramadol administered as a single oral dose, for the relief of acute postoperative pain in adults, and compared to placebo. Two review authors independently considered trials for inclusion in the review, examined issues of study quality and potential bias, and extracted data. For dichotomous outcomes, we calculated risk ratio (RR) and number needed to treat for an additional beneficial outcome (NNT) for dexketoprofen plus tramadol, compared with placebo with 95% confidence intervals (CI). We collected information on the number of participants with at least 50% of

  1. Single dose oral ketoprofen or dexketoprofen for acute postoperative pain in adults.

    Science.gov (United States)

    Gaskell, Helen; Derry, Sheena; Wiffen, Philip J; Moore, R Andrew

    2017-05-25

    This review is an update of "Single dose oral ketoprofen and dexketoprofen for acute postoperative pain in adults" last updated in Issue 4, 2009. Ketoprofen is a non-selective nonsteroidal anti-inflammatory drug (NSAID) used to treat acute and chronic painful conditions. Dexketoprofen is the (S)-enantiomer, which is believed to confer analgesia. Theoretically dexketoprofen is expected to provide equivalent analgesia to ketoprofen at half the dose, with a consequent reduction in gastrointestinal adverse events. This review is one of a series on oral analgesics for acute postoperative pain. Individual reviews have been brought together in two overviews to provide information about the relative efficacy and harm of the different interventions. To assess the efficacy and safety of single dose oral ketoprofen and oral dexketoprofen compared with placebo for acute postoperative pain, using methods that permit comparison with other analgesics evaluated in the same way, and criteria of efficacy recommended by an in-depth study at the individual patient level. For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase from 2009 to 28 March 2017. We also searched the reference lists of retrieved studies and reviews, and two online clinical trial registries. Randomised, double-blind, placebo-controlled trials of single dose orally administered ketoprofen or dexketoprofen in adults with moderate to severe acute postoperative pain. Two review authors independently considered studies for inclusion in the review, examined issues of study quality and potential bias, and extracted data. For dichotomous outcomes, we calculated risk ratio (RR) and number needed to treat for an additional beneficial outcome (NNT) or harmful outcome (NNH) with 95% confidence intervals (CI) for ketoprofen and dexketoprofen, compared with placebo, where there were sufficient data. We collected information on the number of participants with at least 50

  2. Monday Morning Workload Reports (FY15 - 17)

    Data.gov (United States)

    Department of Veterans Affairs — The Monday Morning Workload Report (MMWR) displays a snapshot of the Veterans Benefits Administration’s (VBA) workload as of a specified date, typically the previous...

  3. AAS 228: Day 2 morning

    Science.gov (United States)

    Kohler, Susanna

    2016-06-01

    extremely data-rich. The Galaxy Zoo project also suggests the promising prospect of synergizing the help from citizen scientists and machine learning in analyzing extremely large datasets.Extrasolar Planets: Atmospheres (by Leonardo dos Santos)Antonija Oklopi (Caltech) explains that Raman scattering of light, which works similarly to Rayleigh scattering (the process that makes Earths sky blue), can be used in the future to study the atmospheres of exoplanets. Her work is to create model spectra containing these features, from which we can learn about the presence and altitude of atmospheric clouds. Dr. Carl Melis (University of California, San Diego) studies the inner composition of exoplanets by looking at their remnants after they are destroyed by a dying star. His most recent work suggests that there is a differentiated pollution (from the core and the crust of a planet) in the disk orbiting of a white dwarf star. Samuel Grunblatt (University of Hawaii) introduces us to the main subject of his thesis: a hot-Jupiter observed by Keplers K2 mission transiting an evolved, red giant star. They used some pretty tricky data analysis in order to filter out the noise intrinsic to this type of star.Grunblatt shows the K2 transit before and after removal of granulation effects.Avi Shporer (JPL) asks the question: why are hot Jupiters so large? His research aims to study the correlation between stellar irradiation and planetary radius, and in order to have a more complete picture, they need to detect more gas giants on lower stellar irradiation regions. This idea gave rise to LCOGT K2 Warm Jupiter project, which recently discovered a brown dwarf in a long-period orbit around a Sun-like star. Paul Mason (New Mexico State University) proposes that the Milky Way is evolving to a more habitable galaxy, due to the expansion of the universe, the processing of heavier material inside stars, and the general decrease of ionizing radiation.Evolution of Galaxies (by Ben Cook)Tuesday mornings

  4. Volatile sulphur compounds in morning breath of human volunteers

    NARCIS (Netherlands)

    Snel, Johannes; Burgering, Maurits; Smit, Bart; Noordman, Wouter; Tangerman, Albert; Winkel, Edwin G.; Kleerebezem, Michiel

    Objective: Morning breath contains elevated concentrations of volatile sulphur components (VSCs). Therefore, morning breath is recognised as a surrogate target for interventions on breath quality. Nevertheless, factors influencing morning breath are poorly understood. Our aim was to evaluate

  5. Volatile sulphur compounds in morning breath of human volunteers.

    NARCIS (Netherlands)

    Snel, J.; Burgering, M.; Smit, B.; Noordman, W.; Tangerman, A.; Winkel, E.G.; Kleerebezem, M.

    2011-01-01

    OBJECTIVE: morning breath contains elevated concentrations of volatile sulphur components (VSCs). Therefore, morning breath is recognised as a surrogate target for interventions on breath quality. Nevertheless, factors influencing morning breath are poorly understood. Our aim was to evaluate

  6. Pharmacokinetics of meloxicam in rabbits after oral administration of single and multiple doses.

    Science.gov (United States)

    Fredholm, Daniel V; Carpenter, James W; KuKanich, Butch; Kohles, Micah

    2013-04-01

    To determine the pharmacokinetics of meloxicam (1 mg/kg) in rabbits after oral administration of single and multiple doses. 6 healthy rabbits. A single dose of meloxicam (1 mg/kg, PO) was administered to the rabbits. After a 10-day washout period, meloxicam (1 mg/kg, PO) was administered to rabbits every 24 hours for 5 days. Blood samples were obtained from rabbits at predetermined intervals during both treatment periods. Plasma meloxicam concentrations were determined, and noncompartmental pharmacokinetic analysis was performed. The mean peak plasma concentration and area under the plasma concentration-versus-time curve extrapolated to infinity after administration of a single dose of meloxicam were 0.83 μg/mL and 10.37 h•μg/mL, respectively. After administration of meloxicam for 5 days, the mean peak plasma concentration was 1.33 μg/mL, and the area under the plasma concentration-versus-time curve from the time of administration of the last dose to 24 hours after that time was 18.79 h•μg/mL. For single- and multiple-dose meloxicam experiments, the mean time to maximum plasma concentration was 6.5 and 5.8 hours and the mean terminal half-life was 6.1 and 6.7 hours, respectively. Plasma concentrations of meloxicam for rabbits in the present study were proportionally higher than those previously reported for rabbits receiving 0.2 mg of meloxicam/kg and were similar to those determined for animals of other species that received clinically effective doses. A dose of 1 mg/kg may be necessary to achieve clinically effective circulating concentrations of meloxicam in rabbits, although further studies are needed.

  7. Pharmacokinetics, Safety and Tolerability of Single Oral or Intravenous Administration of 200 mg Tedizolid Phosphate in Adolescents.

    Science.gov (United States)

    Bradley, John S; Flanagan, Shawn D; Arrieta, Antonio C; Jacobs, Richard; Capparelli, Edmund; Prokocimer, Philippe

    2016-06-01

    Tedizolid is a novel oxazolidinone antibacterial US FDA approved for treatment of acute bacterial skin and skin structure infections in adults. This study assessed the pharmacokinetics, safety and tolerability of tedizolid phosphate in adolescents (12-17 years old) after administration of a single intravenous (IV) or oral dose. In this multicenter, open-label study, a single IV infusion (N = 10) or oral dose (N = 10) of 200 mg tedizolid phosphate was administered to adolescents already receiving antibacterial treatment for presumed or documented infection. Blood and urine samples were collected predose and over 24 hours. Tedizolid pharmacokinetics was generally similar after IV or oral administration of 200 mg tedizolid phosphate. Mean (standard deviation) half-life values were similar for oral and IV routes, 8.3 (2.0) and 6.6 (0.7) hours, respectively. Absolute oral bioavailability of tedizolid (90% confidence interval) was 88.8% (70.4%-112.1%). Geometric mean ratio (90% confidence interval) of area under the concentration-time curve values for adolescents relative to values previously reported for adults after 200 mg of single-dose IV or oral administration were 0.847 (0.736-0.975). Tedizolid was well tolerated. Overall pharmacokinetics of tedizolid was similar after administration of a single oral or IV 200 mg dose, and bioavailability was high. Exposure profiles were similar to those in adults. With clinical outcomes based on area under the concentration-time curve/minimum inhibitory concentration and current susceptibility of Gram-positive pathogens, results suggest that the 200 mg daily regimen of tedizolid phosphate can be extended to adolescents for clinical trials, and that dose adjustment may not be required when switching routes.

  8. AAS 228: Day 1 morning

    Science.gov (United States)

    Kohler, Susanna

    2016-06-01

    Editors Note:This week were at the 228th AAS Meeting in San Diego, CA. Along with a team ofauthors from astrobites.com, I will bewritingupdates on selectedevents at themeeting and posting twiceeach day. Follow along here or atastrobites.com, or catch ourlive-tweeted updates from the@astrobites Twitter account. The usual posting schedule for AAS Nova will resumenext week.Come visit astrobites at the AAS booth we have swag!Things kicked off last night at our undergraduate reception booth. Thanks to all of you who stopped by we were delightedto hear from undergrads who already know and love the site, educators who want to use it in their classrooms, and students who had not yet been introduced to astrobites and were excited about a new resource!For the rest of the meeting we will be stationed at theAAS booth in the exhibit hall (booth #211-213), so drop by if you want to learn more (or pick up swag: weve got lots of stickers and sunglasses)!Mondaymorning was the official start of the meeting. Here are just a few of the talks and workshops astrobiters attended this morning.Opening Address(by Susanna Kohler)AAS President Meg Urry kicked off the meeting this morning at 8am with an overview of some of the great endeavors AAS is supporting. We astrobiters had personal motivation to drag ourselves out of bed that early: during this session, Urryannounced the new partnership between AAS and astrobites!Urry touched on some difficult topics in her welcome, including yesterdays tragedy in Orlando. Shereiteratedthe AASs support fortheCommittee for Sexual-Orientation and Gender Minorities in Astronomy (SGMA). She also reminded meeting attendees about the importance ofkeeping conference interactions professional, and pointed to the meetings anti-harassment policy.Partnership Announcement (by Michael Zevin)This morning, the American Astronomical Society announced the new partnership that it will have with Astrobites! We are beyond excited to embark on this new partnership with the

  9. Stable engraftment of human microbiota into mice with a single oral gavage following antibiotic conditioning.

    Science.gov (United States)

    Staley, Christopher; Kaiser, Thomas; Beura, Lalit K; Hamilton, Matthew J; Weingarden, Alexa R; Bobr, Aleh; Kang, Johnthomas; Masopust, David; Sadowsky, Michael J; Khoruts, Alexander

    2017-08-01

    Human microbiota-associated (HMA) animal models relying on germ-free recipient mice are being used to study the relationship between intestinal microbiota and human disease. However, transfer of microbiota into germ-free animals also triggers global developmental changes in the recipient intestine, which can mask disease-specific attributes of the donor material. Therefore, a simple model of replacing microbiota into a developmentally mature intestinal environment remains highly desirable. Here we report on the development of a sequential, three-course antibiotic conditioning regimen that allows sustained engraftment of intestinal microorganisms following a single oral gavage with human donor microbiota. SourceTracker, a Bayesian, OTU-based algorithm, indicated that 59.3 ± 3.0% of the fecal bacterial communities in treated mice were attributable to the donor source. This overall degree of microbiota engraftment was similar in mice conditioned with antibiotics and germ-free mice. Limited surveys of systemic and mucosal immune sites did not show evidence of immune activation following introduction of human microbiota. The antibiotic treatment protocol described here followed by a single gavage of human microbiota may provide a useful, complimentary HMA model to that established in germ-free facilities. The model has the potential for further in-depth translational investigations of microbiota in a variety of human disease states.

  10. Good Bye Rush Hour Trains, Hello Morning Walks. Changes in Morning Experience for Japanese Retirees

    OpenAIRE

    Yohko Tsuji

    2014-01-01

    Morning is the "junction between nighttime and daytime" when most people experience the transition from restful sleep to actions. It comes every day with the light dispelling the darkness and human motions and bird chirpings breaking the stillness of the night. While the morning thus described is repeated day after day, people’s experiences of it may change drastically when they retire. In this article, I will examine such changes in morning experiences among Japanese retirees who live in ...

  11. Pharmacokinetics after oral and intravenous administration of a single dose of tramadol hydrochloride to Hispaniolan Amazon parrots (Amazona ventralis).

    Science.gov (United States)

    Souza, Marcy J; Sanchez-Migallon Guzman, David; Paul-Murphy, Joanne R; Cox, Sherry K

    2012-08-01

    To determine pharmacokinetics after IV and oral administration of a single dose of tramadol hydrochloride to Hispaniolan Amazon parrots (Amazona ventralis). 9 healthy adult Hispaniolan Amazon parrots (3 males, 5 females, and 1 of unknown sex). Tramadol (5 mg/kg, IV) was administered to the parrots. Blood samples were collected from -5 to 720 minutes after administration. After a 3-week washout period, tramadol (10 and 30 mg/kg) was orally administered to parrots. Blood samples were collected from -5 to 1,440 minutes after administration. Three formulations of oral suspension (crushed tablets in a commercially available suspension agent, crushed tablets in sterile water, and chemical-grade powder in sterile water) were evaluated. Plasma concentrations of tramadol and its major metabolites were measured via high-performance liquid chromatography. Mean plasma tramadol concentrations were > 100 ng/mL for approximately 2 to 4 hours after IV administration of tramadol. Plasma concentrations after oral administration of tramadol at a dose of 10 mg/kg were 100 ng/mL for approximately 6 hours after administration. Oral administration of the suspension consisting of the chemical-grade powder resulted in higher plasma tramadol concentrations than concentrations obtained after oral administration of the other 2 formulations; however, concentrations differed significantly only at 120 and 240 minutes after administration. Oral administration of tramadol at a dose of 30 mg/kg resulted in plasma concentrations (> 100 ng/mL) that have been associated with analgesia in Hispaniolan Amazon parrots.

  12. Impact of a single educational session on oral hygiene practices among children of a primary school of Meerut, India

    Directory of Open Access Journals (Sweden)

    Pawan Parashar

    2013-10-01

    Full Text Available Oral health promotion through schools is recommended by the World Health Organization (WHO for improving knowledge, attitude, and behavior related to oral health and for prevention and control of dental diseases among school children. In low resource settings, it is important to develop evidence for health education methods in oral health behavioral practices. The objectives of this study were to assess both the baseline awareness and practices regarding oral hygiene and the impact of a single education session on the change in oral health behavior. A school based, cross-sectional study on 112 primary school children was conducted after obtaining the consent of the school authorities and parents. A pretested, structured proforma was used for baseline awareness and behavior regarding oral health. A 30 min educational session was imparted and after 1 month, and the oral health practices were reassessed to find out the impact of the education session. Baseline survey revealed the following findings. Self-reported dental problems were found in 48.22% of the children in the last 6 months. When asked about the risk factors for dental problems, 28.57% mentioned eating sweets followed by improper brushing, whereas 40.17% were not aware about any risk factor for dental problems. It was found that 28.57% of the children did not brush their teeth regularly, whereas 35.71% used a tooth-brush for brushing their teeth. After the intervention, it was observed that there was a significant improvement in the proportion of children using a toothbrush for cleaning their teeth and of those who rinsed their mouth after meals. In conclusion, even a single education session was found to be effective in bringing about a change in the oral health behavior of primary school children.

  13. Interbacterial Adhesion Networks within Early Oral Biofilms of Single Human Hosts.

    Science.gov (United States)

    Palmer, Robert J; Shah, Nehal; Valm, Alex; Paster, Bruce; Dewhirst, Floyd; Inui, Taichi; Cisar, John O

    2017-06-01

    Specific interbacterial adhesion, termed coaggregation, is well established for three early colonizers of the plaque biofilm: streptococci, actinomyces, and veillonellae. However, little is known about interactions of other early colonizers and about the extent of interactions within the bacterial community from a single host. To address these gaps, subject-specific culture collections from two individuals were established using an intraoral biofilm retrieval device. Molecular taxonomy (Human Oral Microbe Identification Microarray [HOMIM]) analysis of biofilm samples confirmed the integrity and completeness of the collections. HOMIM analysis verified the isolation of Streptococcus gordonii and S. anginosus from only one subject, as well as isolation of a previously uncultivated streptococcal phylotype from the other subject. Strains representative of clonal diversity within each collection were further characterized. Greater than 70% of these streptococcal strains from each subject coaggregated with at least one other coisolate. One-third of the strains carry a known coaggregation mediator: receptor polysaccharide (RPS). Almost all nonstreptococcal isolates coaggregated with other coisolates. Importantly, certain Rothia strains demonstrated more coaggregations with their coisolated bacteria than did any Streptococcus or Actinomyces strain, and certain Haemophilus isolates participated in twice as many. Confocal microscopy of undisturbed biofilms showed that Rothia and Haemophilus each occur in small multispecies microcolonies. However, in confluent high-biomass regions, Rothia occurred in islands whereas Haemophilus was distributed throughout. Together, the data demonstrate that coaggregation networks within an individual's oral microflora are extensive and that Rothia and Haemophilus can be important initiators of cell-cell interactions in the early biofilm. IMPORTANCE Extensive involvement of specific interbacterial adhesion in dental plaque biofilm formation has

  14. Phylogenetic group- and species-specific oligonucleotide probes for single-cell detection of lactic acid bacteria in oral biofilms

    NARCIS (Netherlands)

    Quevedo, Beatrice; Giertsen, Elin; Zijnge, Vincent; Luethi-Schaller, Helga; Guggenheim, Bernhard; Thurnheer, Thomas; Gmuer, Rudolf

    2011-01-01

    Background: The purpose of this study was to design and evaluate fluorescent in situ hybridization (FISH) probes for the single-cell detection and enumeration of lactic acid bacteria, in particular organisms belonging to the major phylogenetic groups and species of oral lactobacilli and to

  15. Single dose oral ibuprofen plus caffeine for acute postoperative pain in adults.

    Science.gov (United States)

    Derry, Sheena; Wiffen, Philip J; Moore, R Andrew

    2015-07-14

    There is good evidence that combining two different analgesics in fixed doses in a single tablet can provide better pain relief in acute pain and headache than either drug alone, and that the drug-specific benefits are essentially additive. This appears to be broadly true in postoperative pain and migraine headache across a range of different drug combinations, and when tested in the same and different trials. Adding caffeine to analgesics also increases the number of people obtaining good pain relief. Combinations of ibuprofen and caffeine are available without prescription in some parts of the world. To assess the analgesic efficacy and adverse effects of a single oral dose of ibuprofen plus caffeine for moderate to severe postoperative pain, using methods that permit comparison with other analgesics evaluated in standardised trials using almost identical methods and outcomes. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Oxford Pain Relief Database, two clinical trial registries, and the reference lists of articles. The date of the most recent search was 1 February 2015. Randomised, double-blind, placebo- or active-controlled clinical trials of single dose oral ibuprofen plus caffeine for acute postoperative pain in adults. Two review authors independently considered trials for inclusion in the review, assessed risk of bias, and extracted data. We used the area under the pain relief versus time curve to derive the proportion of participants with at least 50% pain relief over six hours prescribed either ibuprofen plus caffeine or placebo. We calculated the risk ratio (RR) and number needed to treat to benefit (NNT). We used information on the use of rescue medication to calculate the proportion of participants requiring rescue medication and the weighted mean of the median time to use. We also collected information on adverse effects. We identified five randomised, double-blind studies with 1501 participants, but

  16. Pharmacokinetics of solithromycin (CEM-101) after single or multiple oral doses and effects of food on single-dose bioavailability in healthy adult subjects.

    Science.gov (United States)

    Still, J Gordon; Schranz, Jennifer; Degenhardt, Thorsten P; Scott, Drusilla; Fernandes, Prabhavathi; Gutierrez, Maria J; Clark, Kay

    2011-05-01

    The pharmacokinetics of orally administered solithromycin (CEM-101), a novel fluoroketolide, were evaluated in healthy subjects in three phase 1 studies. In two randomized, double-blinded, placebo-controlled studies, escalating single oral doses of solithromycin (50 to 1,600 mg) or seven oral daily doses (200 to 600 mg) of solithromycin were administered. A third study evaluated the effects of food on the bioavailability of single oral doses (400 mg) of solithromycin. Following single doses, the median time to peak concentration (Tmax) ranged from 1.5 h to 6 h. The mean maximum measured plasma concentration (Cmax) ranged from 0.0223 μg/ml to 19.647 μg/ml, and the area under the concentration-versus-time curve from time zero to time t (AUC0-t) ranged from 0.0402 μg·h/ml to 28.599 μg·h/ml. There was no effect of high-fat food on the oral bioavailability of solithromycin. In the multiple-dose study, after 7 days, the mean maximum measured plasma solithromycin concentration at steady-state (Cmax,ss) ranged from 0.248 to 1.50 μg/ml, and the area under the concentration-versus-time curve over the final dosing interval (AUCτ) ranged from 2.310 to 18.41 μg·h/ml. These values indicate a greater than proportional increase in exposure at 200 and 400 mg but a proportional exposure at 600 mg. Median Tmax values remained constant between day 1 and day 7. Moderate accumulation ratios of solithromycin were observed after 7 days of dosing. All dose regimens of solithromycin were well tolerated, and no discontinuations due to an adverse event occurred. The human pharmacokinetic profile and tolerability of solithromycin, combined with its in vitro potency and efficacy in animal models against a broad spectrum of pathogens, support further development of solithromycin.

  17. Tissue distribution and elimination of BDE 47 in mice following a single oral dose

    Energy Technology Data Exchange (ETDEWEB)

    Staskal, D. [Curriculum in Toxicology, Chapel Hill, NC (United States); Diliberto, J.; DeVito, M.; Birnbaum, L. [US EPA, ORD, NHEERL, ETD, RTP (United States)

    2004-09-15

    2,2',4,4'-Tetrabromodiphenyl ether (BDE 47) is a polybrominated diphenyl ether (PBDE) congener which is part of a class of brominated flame retardants (BFRs) commonly used in a variety of highly flammable consumer goods. Concern for the effects of PBDEs has increased significantly in recent years as their presence has been detected in environmental samples and in human tissues at steadily increasing concentrations. Despite its small contribution to the PBDE global production and usage, BDE 47 is the major congener found in environmental samples and human tissue. Limited toxicology studies suggest that BDE 47 is a developmental neurotoxicant and an endocrine disruptor however, several data gaps exist and must be investigated in order to evaluate the human health risk of BDE 47. This study investigated basic toxicokinetic properties of BDE 47 in female C57BL/6J mice. Here we report the effect of time on the absorption, distribution, and excretion following a single, oral dose of 14C-labeled BDE 47. Animals were administered 1.0mg BDE 47/kg bw, a dose chosen based on previous studies. Distribution and elimination were monitored at several time points ranging from 1 hour to 21 days following exposure. Data from these basic toxicokinetic studies will be applied to studies investigating the toxicokinetics of BDE 47 in a developmental model as well as in the development of a physiologically-based pharmacokinetic (PBPK) model.

  18. Effects of a single, oral 60 mg caffeine dose on attention in healthy adult subjects.

    Science.gov (United States)

    Wilhelmus, Micha Mm; Hay, Justin L; Zuiker, Rob Gja; Okkerse, Pieter; Perdrieu, Christelle; Sauser, Julien; Beaumont, Maurice; Schmitt, Jeroen; van Gerven, Joop Ma; Silber, Beata Y

    2017-02-01

    Caffeine induces positive effects on sustained attention, although studies assessing the acute effects of low caffeine dose (caffeine on sustained attention in tests lasting up to 45 minutes using 82 low or non-caffeine-consuming healthy male ( n=41) and female ( n=41) adults aged between 40 and 60 years. Vigilance was measured using Mackworth Clock test, Rapid Visual Information Processing Test, adaptive tracking test, saccadic eye movement and attention switch test. Effects on mood and fatigue were analysed using Bond and Lader and Caffeine Research visual analogue scales, and Samn-Perelli questionnaire. Saliva sampling was performed for both compliance and caffeine pharmacokinetic analysis. Administration of a 60 mg caffeine dose resulted in a significant improvement in sustained attention compared with the placebo. Also a significantly improved peak saccadic velocity and reaction time performance was found, and decreased error rate. Significantly increased feelings of alertness, contentment and overall mood after caffeine treatment compared with placebo were observed. This study demonstrated that in healthy adult subjects oral administration of a single 60 mg caffeine dose elicited a clear enhancement of sustained attention and alertness, measured both in multiple objective performances and in subjective scales.

  19. Morning or evening administration of nasal calcitonin?

    DEFF Research Database (Denmark)

    Schlemmer, A; Ravn, Pernille; Hassager, C

    1997-01-01

    The purpose of this study was to examine the effect of intranasal salmon calcitonin (sCT) administration (200 IE), given either in the morning (8:00) or evening (21:00), on the known circadian variation in biochemical markers of bone turnover. An open, placebo-controlled, randomized, crossover......). Serum osteocalcin (sOC) was measured by radioimmunoassay (RIA). The first 24 h study was performed without intervention. Prior to this control study the participants were randomized to either morning (8:00) or evening (21:00) sCT (200 IE). sCT administrations were given 4-5 days prior to and during...... in late afternoon. Both morning and evening administration of sCT significantly decreased the urinary excretion of CrossLaps/Cr approximately 3-6 h after administration with a subsequent rebound effect. sOC did not exhibit a significant circadian variation and was not affected by the calcitonin. The 24 h...

  20. Pharmacokinetics of meloxicam after intramuscular and oral administration of a single dose to American flamingos (Phoenicopertus ruber).

    Science.gov (United States)

    Boonstra, Jennifer L; Cox, Sherry K; Martin-Jimenez, Tomas

    2017-03-01

    OBJECTIVE To determine pharmacokinetics after IM and oral administration of a single dose of meloxicam to American flamingos (Phoenicopertus ruber). ANIMALS 14 adult flamingos. PROCEDURES Flamingos were allocated to 2 groups. Each group received a dose of meloxicam (1 mg/kg) by the IM or oral route. After a 4-week washout period, groups received meloxicam via the other route of administration. Plasma meloxicam concentrations were measured with high-performance liquid chromatography. Data for each bird were analyzed. Estimated values of selected pharmacokinetic parameters were compared by use of a linear mixed-effects ANOVA. Pooled concentration-time profiles for each route of administration were analyzed to examine the influence of body weight on pharmacokinetics. RESULTS Mean ± SD maximum plasma concentration was 1.00 ± 0.88 μg/mL after oral administration. This was approximately 15% of the mean maximum plasma concentration of 5.50 ± 2.86 μg/mL after IM administration. Mean time to maximum plasma concentration was 1.33 ± 1.32 hours after oral administration and 0.28 ± 0.17 hours after IM administration. Mean half-life of the terminal phase after oral administration (3.83 ± 2.64 hours) was approximately twice that after IM administration (1.83 ± 1.22 hours). CONCLUSIONS AND CLINICAL RELEVANCE Results indicated that the extent and rate of meloxicam absorption were less after oral administration than after IM administration. Intramuscular administration resulted in a short period during which mean plasma concentrations met or exceeded reported efficacious analgesic concentrations in other species, whereas oral administration did not. These results suggested that higher doses may be required for oral administration.

  1. Pharmacokinetics of voriconazole after oral administration of single and multiple doses in Hispaniolan Amazon parrots (Amazona ventralis).

    Science.gov (United States)

    Sanchez-Migallon Guzman, David; Flammer, Keven; Papich, Mark G; Grooters, Amy M; Shaw, Shannon; Applegate, Jeff; Tully, Thomas N

    2010-04-01

    To determine the pharmacokinetics and safety of voriconazole administered orally in single and multiple doses in Hispaniolan Amazon parrots (Amazona ventralis). 15 clinically normal adult Hispaniolan Amazon parrots. Single doses of voriconazole (12 or 24 mg/kg) were administered orally to 15 and 12 birds, respectively; plasma voriconazole concentrations were determined at intervals via high-pressure liquid chromatography. In a multiple-dose trial, voriconazole (18 mg/kg) or water was administered orally to 6 and 4 birds, respectively, every 8 hours for 11 days (beginning day 0); trough plasma voriconazole concentrations were evaluated on 3 days. Birds were monitored daily, and clinicopathologic variables were evaluated before and after the trial. Voriconazole elimination half-life was short (0.70 to 1.25 hours). In the single-dose experiments, higher drug doses yielded proportional increases in the maximum plasma voriconazole concentration (C(max)) and area under the curve (AUC). In the multiple-dose trial, C(max), AUC, and plasma concentrations at 2 and 4 hours were decreased on day 10, compared with day 0 values; however, there was relatively little change in terminal half-life. With the exception of 1 voriconazole-treated parrot that developed polyuria, adverse effects were not evident. In Hispaniolan Amazon parrots, oral administration of voriconazole was associated with proportional kinetics following administration of single doses and a decrease in plasma concentration following administration of multiple doses. Oral administration of 18 mg of voriconazole/kg every 8 hours would require adjustment to maintain therapeutic concentrations during long-term treatment. Safety and efficacy of voriconazole treatment in this species require further investigation.

  2. Comparison of the single dose pharmacokinetics, pharmacodynamics, and safety of two novel oral formulations of dimethandrolone undecanoate (DMAU): a potential oral, male contraceptive.

    Science.gov (United States)

    Ayoub, R; Page, S T; Swerdloff, R S; Liu, P Y; Amory, J K; Leung, A; Hull, L; Blithe, D; Christy, A; Chao, J H; Bremner, W J; Wang, C

    2017-03-01

    Dimethandrolone (DMA, 7α,11β-dimethyl-19-nortestosterone) has both androgenic and progestational activities, ideal properties for a male hormonal contraceptive. In vivo, dimethandrolone undecanoate (DMAU) is hydrolyzed to DMA. We showed previously that single oral doses of DMAU powder in capsule taken with food are well tolerated and effective at suppressing both LH and testosterone (T), but absorption was low. We compared the pharmacokinetics and pharmacodynamics of two new formulations of DMAU, in castor oil and in self-emulsifying drug delivery systems (SEDDS), with the previously tested powder formulation. DMAU was dosed orally in healthy adult male volunteers at two academic medical centers. For each formulation tested in this double-blind, placebo-controlled study, 10 men received single, escalating, oral doses of DMAU (100, 200, and 400 mg) and two subjects received placebo. All doses were evaluated for both fasting and with a high fat meal. All three formulations were well tolerated without clinically significant changes in vital signs, blood counts, or serum chemistries. For all formulations, DMA and DMAU showed higher maximum (p food, but only the SEDDS formulation was effectively suppressed serum T when given fasting. We conclude that while all three formulations of oral DMAU are effective and well tolerated when administered with food, DMAU in oil and SEDDS increased conversion to DMA, and SEDDS may have some effectiveness when given fasting. These properties might be advantageous for the application of DMAU as a male contraceptive. © 2016 American Society of Andrology and European Academy of Andrology.

  3. A Phase 2 Trial of Oral Solithromycin 1200 mg or 1000 mg as Single-Dose Oral Therapy for Uncomplicated Gonorrhea.

    Science.gov (United States)

    Hook, Edward W; Golden, Matthew; Jamieson, Brian D; Dixon, Paula B; Harbison, Hanne S; Lowens, Sylvan; Fernandes, Prabhavathi

    2015-10-01

    Progressive resistance to antimicrobial agents has reduced options for gonorrhea therapy worldwide. Solithromycin (CEM-101) is a novel oral fluoroketolide antimicrobial with substantial in vitro activity against Neisseria gonorrhoeae. We conducted a phase 2 trial of 2 oral doses of solithromycin (1200 and 1000 mg) for treatment of uncomplicated gonorrhea. A total of 59 participants were enrolled and treated in this trial; 28 participants received 1200 mg of solithromycin and 31 received 1000 mg. Forty-six (78%) participants had positive cultures for N. gonorrhoeae at the time of enrollment: 24 of the 28 persons (86%) who received 1200 mg of oral solithromycin, and 22 of 31 (71%) who received 1000 mg. In addition, 8 participants had positive pharyngeal gonococcal cultures, and 4 had positive rectal cultures. All patients with positive cultures for N. gonorrhoeae were cured at all sites of infection. Chlamydia trachomatis and Mycoplasma genitalium coinfections were evaluated using nucleic acid amplification tests and were negative at 1 week of follow-up in 9 of 11 (82%) participants positive for C. trachomatis and 7 of 10 (70%) participants positive for M. genitalium. Mild dose-related gastrointestinal side effects (nausea, loose stools, vomiting) were common but did not limit therapy. Oral single-dose solithromycin, in doses of 1000 mg and 1200 mg, was 100% effective for treatment of culture-proven gonorrhea at genital, oral, and rectal sites of infection and is a promising new agent for gonorrhea treatment. NCT01591447. © 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.

  4. Single dose oral ketoprofen and dexketoprofen for acute postoperative pain in adults.

    Science.gov (United States)

    Barden, Jodie; Derry, Sheena; McQuay, Henry J; Moore, R Andrew

    2009-10-07

    Ketoprofen is a non-selective non-steroidal anti-inflammatory drug (NSAID) used to treat acute and chronic painful conditions. Dexketoprofen is the (S)-enantiomer, which is believed to confer analgesia. Theoretically dexketoprofen is expected to provide equivalent analgesia to ketoprofen at half the dose, with a consequent reduction in gastrointestinal adverse events. To assess efficacy, duration of action, and associated adverse events of single dose oral ketoprofen and dexketoprofen in acute postoperative pain in adults. We searched Cochrane CENTRAL, MEDLINE, EMBASE and the Oxford Pain Relief Database for studies to August 2009. Randomised, double blind, placebo-controlled trials of single dose orally administered ketoprofen and dexketoprofen in adults with moderate to severe acute postoperative pain. Two review authors independently assessed trial quality and extracted data. Pain relief or pain intensity data were extracted and converted into the dichotomous outcome of number of participants with at least 50% pain relief over 4 to 6 hours, from which relative risk and number-needed-to-treat-to-benefit (NNT) were calculated. Numbers of participants using rescue medication over specified time periods, and time to use of rescue medication, were sought as additional measures of efficacy. Information on adverse events and withdrawals was collected. Fourteen studies compared ketoprofen (968 participants) at mainly 25 mg and 50 mg with placebo (520 participants). Seven studies compared dexketoprofen (681 participants) at mainly 10 mg to 25 mg with placebo (289 participants). Studies were of adequate reporting quality, and participants had pain following dental, orthopaedic, obstetric, gynaecological and general surgery. There was considerable clinical heterogeneity between studies in dental and other types of surgery, particularly bunionectomy, which limited analysis.Ketoprofen at doses between 12.5 mg and 100 mg produced NNTs for at least 50% pain relief over 4 to 6

  5. Human metabolism and excretion kinetics of the fragrance lysmeral after a single oral dosage.

    Science.gov (United States)

    Scherer, Max; Koch, Holger M; Schütze, Andre; Pluym, Nikola; Krnac, Dusan; Gilch, Gerhard; Leibold, Edgar; Scherer, Gerhard

    2017-03-01

    2-(4-tert-Butylbenzyl)propionaldehyde, also known as lysmeral, lilial or lily-aldehyde (CAS No 80-54-6) is a synthetic fragrance used in a variety of consumer products like perfumes, after shave lotions, cosmetics and others. Due to its broad application, lysmeral was selected for the development of a biomonitoring method for the general population within the frame of the cooperation project of the Federal Ministry for the Environment (BMUB) and the German Chemical Industry Association (VCI). The project also comprises the identification of suitable biomarkers of exposure in human urine as well as basic toxicokinetic data after defined, experimental exposure. For this purpose, 5 healthy subjects were orally dosed once with 5.26mg lysmeral. Urine was collected immediately before and for 48h after administration of the fragrance. The lysmeral metabolites lysmerol, lysmerylic acid, hydroxylated lysmerylic acid and 4-tert-butylbenzoic acid (TBBA) were determined in all urine samples by a newly developed UPLC-MS/MS (ultra-high pressure liquid chromatography combined with tandem mass spectrometry) method. Peak excretion for all metabolites occurred between 2 and 5h after oral application, with the primary metabolites (lysmerol and lysmerylic acid) being excreted about 1h earlier than the secondary metabolites (hydroxylated lysmerylic acid and TBBA). More than 90% of all measured lysmeral metabolites were excreted after 12h, with the renal excretion being virtually complete after 48h. After this time period, TBBA, lysmerol, lysmerylic acid and hydroxyl-lysmerylic acid represent on average 14.3, 1.82, 0.20 and 0.16%, respectively, of the dose administered. In total, the 4 metabolites determined represent about 16.5% of the dose. With the conversion factors derived from the controlled human study, we estimated median exposure doses for lysmeral in a group of 40 human volunteers from the general population of approximately 140-220μg per day. In conclusion, the lysmeral

  6. Antimicrobial Effect of a Single Dose of Amoxicillin on the Oral Microbiota

    NARCIS (Netherlands)

    Wexell, Cecilia Larsson; Ryberg, Henrik; Andersson, Wivi-Anne Sjoberg; Blomqvist, Susanne; Colin, Pieter; Van Bocxlaer, Jan; Dahlen, Gunnar

    Purpose: Amoxicillin is commonly used in oral surgery for antimicrobial prophylaxis against surgical-site infection and bacteremia because of its effect on oral streptococci. The aim of this study was to determine whether amoxicillin reaches the break-point concentrations in saliva and has any

  7. Cool city mornings by urban heat

    NARCIS (Netherlands)

    Pietersen-Theeuwes, N.E.; Steeneveld, G.J.; Ronda, R.J.; Rotach, M.; Holtslag, A.A.M.

    2015-01-01

    The urban heat island effect is a phenomenon observed worldwide, i.e. evening and nocturnal temperatures in cities are usually several degrees higher than in the surrounding countryside. In contrast, cities are sometimes found to be cooler than their rural surroundings in the morning and early

  8. Pharmacokinetics of meloxicam after intravenous, intramuscular, and oral administration of a single dose to Hispaniolan Amazon parrots (Amazona ventralis).

    Science.gov (United States)

    Molter, Christine M; Court, Michael H; Cole, Gretchen A; Gagnon, David J; Hazarika, Suwagmani; Paul-Murphy, Joanne R

    2013-03-01

    To compare pharmacokinetics after IV, IM, and oral administration of a single dose of meloxicam to Hispaniolan Amazon parrots (Amazona ventralis). 11 healthy parrots. Cohorts of 8 of the 11 birds comprised 3 experimental groups for a crossover study. Pharmacokinetics were determined from plasma concentrations measured via high-performance liquid chromatography after IV, IM, and oral administration of meloxicam at a dose of 1 mg/kg. Initial mean ± SD plasma concentration of 17.3 ± 9.0 μg/mL was measured 5 minutes after IV administration, whereas peak mean concentration was 9.3 ± 1.8 μg/mL 15 minutes after IM administration. At 12 hours after administration, mean plasma concentrations for IV (3.7 ± 2.5 μg/mL) and IM (3.5 ± 2.2 μg/mL) administration were similar. Peak mean plasma concentration (3.5 ± 1.2 μg/mL) was detected 6 hours after oral administration. Absolute systemic bioavailability of meloxicam after IM administration was 100% but was lower after oral administration (range, 49% to 75%). Elimination half-lives after IV, IM, and oral administration were similar (15.9 ± 4.4 hours, 15.1 ± 7.7 hours, and 15.8 ± 8.6 hours, respectively). Pharmacokinetic data may provide useful information for use of meloxicam in Hispaniolan Amazon parrots. A mean plasma concentration of 3.5 μg/mL would be expected to provide analgesia in Hispaniolan Amazon parrots; however, individual variation may result in some birds having low plasma meloxicam concentrations after IV, IM, or oral administration. After oral administration, meloxicam concentration slowly reached the target plasma concentration, but that concentration was not sustained in most birds.

  9. Multiple single-cell genomes provide insight into functions of uncultured Deltaproteobacteria in the human oral cavity.

    Directory of Open Access Journals (Sweden)

    Alisha G Campbell

    Full Text Available Despite a long history of investigation, many bacteria associated with the human oral cavity have yet to be cultured. Studies that correlate the presence or abundance of uncultured species with oral health or disease highlight the importance of these community members. Thus, we sequenced several single-cell genomic amplicons from Desulfobulbus and Desulfovibrio (class Deltaproteobacteria to better understand their function within the human oral community and their association with periodontitis, as well as other systemic diseases. Genomic data from oral Desulfobulbus and Desulfovibrio species were compared to other available deltaproteobacterial genomes, including from a subset of host-associated species. While both groups share a large number of genes with other environmental Deltaproteobacteria genomes, they encode a wide array of unique genes that appear to function in survival in a host environment. Many of these genes are similar to virulence and host adaptation factors of known human pathogens, suggesting that the oral Deltaproteobacteria have the potential to play a role in the etiology of periodontal disease.

  10. Morning symptoms in COPD: a treatable yet often overlooked factor.

    Science.gov (United States)

    van Buul, Amanda R; Kasteleyn, Marise J; Chavannes, Niels H; Taube, Christian

    2017-04-01

    Chronic obstructive pulmonary disease (COPD) patients experience the morning as the worst period of the day. Nevertheless, morning symptoms are not mentioned in COPD guidelines. Areas covered: Different topics on morning symptoms are covered in this review to underline their importance: occurrence, tools for assessment and therapies to limit morning symptoms. Expert commentary: Morning symptoms are common and have a negative influence on a patient's life. Pharmacotherapy seems to be effective in decreasing morning symptoms. A validated tool to assess morning symptoms is lacking. Therefore, more research should focus on assessing morning symptoms with a validated tool to further prove the effect of (pharmaco-) therapy. This will hopefully result in inclusion of morning symptoms in future guidelines.

  11. Pharmacokinetics of Solithromycin (CEM-101) after Single or Multiple Oral Doses and Effects of Food on Single-Dose Bioavailability in Healthy Adult Subjects▿

    Science.gov (United States)

    Still, J. Gordon; Schranz, Jennifer; Degenhardt, Thorsten P.; Scott, Drusilla; Fernandes, Prabhavathi; Gutierrez, Maria J.; Clark, Kay

    2011-01-01

    The pharmacokinetics of orally administered solithromycin (CEM-101), a novel fluoroketolide, were evaluated in healthy subjects in three phase 1 studies. In two randomized, double-blinded, placebo-controlled studies, escalating single oral doses of solithromycin (50 to 1,600 mg) or seven oral daily doses (200 to 600 mg) of solithromycin were administered. A third study evaluated the effects of food on the bioavailability of single oral doses (400 mg) of solithromycin. Following single doses, the median time to peak concentration (Tmax) ranged from 1.5 h to 6 h. The mean maximum measured plasma concentration (Cmax) ranged from 0.0223 μg/ml to 19.647 μg/ml, and the area under the concentration-versus-time curve from time zero to time t (AUC0–t) ranged from 0.0402 μg · h/ml to 28.599 μg · h/ml. There was no effect of high-fat food on the oral bioavailability of solithromycin. In the multiple-dose study, after 7 days, the mean maximum measured plasma solithromycin concentration at steady-state (Cmax,ss) ranged from 0.248 to 1.50 μg/ml, and the area under the concentration-versus-time curve over the final dosing interval (AUCτ) ranged from 2.310 to 18.41 μg · h/ml. These values indicate a greater than proportional increase in exposure at 200 and 400 mg but a proportional exposure at 600 mg. Median Tmax values remained constant between day 1 and day 7. Moderate accumulation ratios of solithromycin were observed after 7 days of dosing. All dose regimens of solithromycin were well tolerated, and no discontinuations due to an adverse event occurred. The human pharmacokinetic profile and tolerability of solithromycin, combined with its in vitro potency and efficacy in animal models against a broad spectrum of pathogens, support further development of solithromycin. PMID:21282444

  12. Single oral dose pharmacokinetics of decursin and decursinol angelate in healthy adult men and women.

    Directory of Open Access Journals (Sweden)

    Jinhui Zhang

    Full Text Available The ethanol extract of Angelica gigas Nakai (AGN root has promising anti-cancer and other bioactivities in rodent models. It is currently believed that the pyranocoumarin isomers decursin (D and decursinol angelate (DA contribute to these activities. We and others have documented that D and DA were rapidly converted to decursinol (DOH in rodents. However, our in vitro metabolism studies suggested that D and DA might be metabolized differently in humans. To test this hypothesis and address a key question for human translatability of animal model studies of D and DA or AGN extract, we conducted a single oral dose human pharmacokinetic study of D and DA delivered through an AGN-based dietary supplement Cogni.Q (purchased from Quality of Life Labs, Purchase, NY in twenty healthy subjects, i.e., 10 men and 10 women, each consuming 119 mg D and 77 mg DA from 4 vegicaps. Analyses of plasma samples using UHPLC-MS/MS showed mean time to peak concentration (Tmax of 2.1, 2.4 and 3.3 h and mean peak concentration (Cmax of 5.3, 48.1 and 2,480 nmol/L for D, DA and DOH, respectively. The terminal elimination half-life (t1/2 for D and DA was similar (17.4 and 19.3 h and each was much longer than that of DOH (7.4 h. The mean area under the curve (AUC0-48h for D, DA and DOH was estimated as 37, 335 and 27,579 h∙nmol/L, respectively. Gender-wise, men absorbed the parent compounds faster and took shorter time to reach DOH peak concentration. The human data supported an extensive conversion of D and DA to DOH, even though they metabolized DA slightly slower than rodents. Therefore, the data generated in rodent models concerning anti-cancer efficacy, safety, tissue distribution and pharmacodynamic biomarkers will likely be relevant for human translation.ClinicalTrials.gov NCT02114957.

  13. Cool city mornings by urban heat

    Science.gov (United States)

    Theeuwes, Natalie E.; Steeneveld, Gert-Jan; Ronda, Reinder J.; Rotach, Mathias W.; Holtslag, Albert A. M.

    2015-11-01

    The urban heat island effect is a phenomenon observed worldwide, i.e. evening and nocturnal temperatures in cities are usually several degrees higher than in the surrounding countryside. In contrast, cities are sometimes found to be cooler than their rural surroundings in the morning and early afternoon. Here, a general physical explanation for this so-called daytime urban cool island (UCI) effect is presented and validated for the cloud-free days in the BUBBLE campaign in Basel, Switzerland. Simulations with a widely evaluated conceptual atmospheric boundary-layer model coupled to a land-surface model, reveal that the UCI can form due to differences between the early morning mixed-layer depth over the city (deeper) and over the countryside (shallower). The magnitude of the UCI is estimated for various types of urban morphology, categorized by their respective local climate zones.

  14. Long-term Nasal and Peri-oral Tightening by a Single Fractional Noninsulated Microneedle Radiofrequency Treatment.

    Science.gov (United States)

    Tanaka, Yohei

    2017-02-01

    Background: The skin tightening effects induced by non-insulated microneedle radiofrequency have proved long-lasting. Our previous three-dimensional volumetric assessment showed significant facial tightening for up to six months. However, nasal and peri-oral tightening effects lasted longer. The objective of this study was to investigate the distribution of the long-term volumetric reduction in facial area induced by a single fractional non-insulated microneedle radiofrequency treatment. Methods: Fifteen Asian patients underwent full facial skin tightening using a sharply tapered non-insulated microneedle radiofrequency applicator with a novel fractionated pulse mode. Three-dimensional volumetric assessments were performed at six and 12 months post-treatment. Patients rated their satisfaction using a 5-point scale at each follow up. Results: Objective assessments with superimposed three-dimensional color images showed significant volumetric reduction in the nasal and peri-oral areas at 12 months post-treatment in all patients. Median volumetric reductions at six and 12 months post-treatment were 13.1 and 12.3ml, respectively. All of the patients were satisfied with their results 12 months post-treatment. Side effects were not observed. Conclusions: This single fractional NIMNRF treatment provided long-lasting nasal and peri-oral tightening as shown via 3D volumetric assessment. Moreover, NIMNRF produced minimal complications, downtime, and few side effects. This approach provides safe and effective treatment of skin tightening.

  15. Effervescent N-Acetylcysteine Tablets versus Oral Solution N-Acetylcysteine in Fasting Healthy Adults: An Open-Label, Randomized, Single-Dose, Crossover, Relative Bioavailability Study

    Directory of Open Access Journals (Sweden)

    Spencer C. Greene, MD, FACEP, FACMT

    2016-01-01

    Conclusions: Data from this study of a single dose of 11 g oral NAC demonstrated that effervescent NAC tablets and oral solution NAC met the regulatory criteria for bioequivalence in fasting healthy adult subjects. Effervescent NAC tablets appear to be a more palatable alternative for treatment of acetaminophen overdose. ClinicalTrials.gov identifier: NCT02723669.

  16. A comparison of morning-only and morning/late afternoon Adderall to morning-only, twice-daily, and three times-daily methylphenidate in children with attention-deficit/hyperactivity disorder.

    Science.gov (United States)

    Pelham, W E; Gnagy, E M; Chronis, A M; Burrows-MacLean, L; Fabiano, G A; Onyango, A N; Meichenbaum, D L; Williams, A; Aronoff, H R; Steiner, R L

    1999-12-01

    1) To compare standard twice-daily methylphenidate (MPH) dosing with a single morning dose of MPH and of Adderall during a typical school-day time period, and 2) to conduct a dose-response study of the effects of a late-afternoon (3:30 PM) dose of MPH and Adderall on evening behavior and side effects. Within-subject, placebo-controlled, crossover design. Intensive summer treatment program with a comprehensive behavioral approach. Twenty-one children with attention-deficit/hyperactivity disorder (19 boys and 2 girls), between the ages of 6 and 12 years. Children received, in random order with daily crossovers, each of the following conditions: 1) placebo, 2) 0.3 mg/kg of MPH received 3 times, 3) 0.3 mg/kg of MPH received twice (7:30 AM and 11:30 AM) with 0.15 mg/kg received at 3:30 PM, 4) 0.3 mg/kg of MPH received once in the morning only, 5) 0.3 mg/kg of Adderall received at 7:30 AM and at 3:30 PM, 6) 0.3 mg/kg of Adderall once in the morning with 0.15 mg/kg received at 3:30 PM, 7) 0.3 mg/kg of Adderall received in the morning only. Daily rates of behaviors in social and academic settings, and standardized ratings from counselors and teachers, were assessed for the hours between 8:00 AM and 3:30 PM (a typical school-day). Relative sizes of the medication effects were compared hourly between first daily ingestion (7:30 AM) and 4:45 PM to assess the time course of the 2 drugs. Effects of the 3:30 PM doses on functioning in the evenings at home were evaluated using parent ratings of behavioral and side effects. A single morning dose of Adderall produced equivalent behavioral effects to those of MPH received twice-daily and behavioral effects of that single morning dose lasted throughout the school-day period. One morning dose of MPH was less effective than either 2 daily doses of MPH or 1 dose of Adderall, and seemed to wear off in the early to mid-afternoon. For some children a single morning dose of MPH maintained their behavior for an entire school day in the

  17. The immediate effects of a single bout of aerobic exercise on oral glucose tolerance across the glucose tolerance continuum

    DEFF Research Database (Denmark)

    Knudsen, Sine H; Karstoft, Kristian; Pedersen, Bente K

    2014-01-01

    We investigated glucose tolerance and postprandial glucose fluxes immediately after a single bout of aerobic exercise in subjects representing the entire glucose tolerance continuum. Twenty-four men with normal glucose tolerance (NGT), impaired glucose tolerance (IGT), or type 2 diabetes (T2D; age......: 56 ± 1 years; body mass index: 27.8 ± 0.7 kg/m(2), P > 0.05) underwent a 180-min oral glucose tolerance test (OGTT) combined with constant intravenous infusion of [6,6-(2)H2]glucose and ingestion of [U-(13)C]glucose, following 1 h of exercise (50% of peak aerobic power) or rest. In both trials......, plasma glucose concentrations and kinetics, insulin, C-peptide, and glucagon were measured. Rates (mg kg(-1) min(-1)) of glucose appearance from endogenous (RaEndo) and exogenous (oral glucose; Ra OGTT) sources, and glucose disappearance (Rd) were determined. We found that exercise increased RaEndo, Ra...

  18. Comparative single-dose pharmacokinetics of rasagiline in minipigs after oral dosing or transdermal administration via a newly developed patch.

    Science.gov (United States)

    Lin, Yu; Zou, Yanye; Lin, Jialiang; Zhang, Tao; Deng, Jie

    2013-08-01

    1. A rasagiline transdermal patch was developed for the treatment of early and advanced Parkinson's disease. Relevant pharmacokinetic parameters of rasagiline obtained after transdermal administration to minipigs were compared with those of rasagiline after oral administration. 2. A total of 18 minipigs were randomly divided into three groups (six animals for each group). A single dose of 1 mg rasagiline tablet was orally administrated to one group. Meanwhile, single dose of 1.25 and 2.5 mg (2 and 4 cm(2)) rasagiline patches were given (at the postauricular skin) to the other two groups, respectively. The pharmacokinetic parameters such as plasma half-life (t1/2), time to peak plasma-concentration (Tmax), mean residence time (MRT), area under the curve (AUC(0-t)) were significantly (p rasagiline (1.25 mg patch: 11.8 ± 6.5 h, 2.5 mg patch: 12.5 ± 4.7 h) in minipig following transdermal administration was significantly prolonged as compared with that following the oral administration (1 mg tablet: 4.7 ± 2.5 h). The dose-normalized relative bioavailability of rasagiline patch in minipig were 178.5% and 156.4%, respectively, for 1.25 and 2.5 mg patches compared with 1 mg rasagiline tablet. The prolonged t1/2 and increased bioavailability of rasagiline patch suggested a possible longer dosing interval compared with oral tablet.

  19. Pharmacokinetic Evaluation of a Single Intramuscular High Dose versus an Oral Long-Term Supplementation of Cholecalciferol.

    Directory of Open Access Journals (Sweden)

    Katharina Wylon

    Full Text Available Vitamin D deficiency is frequent during the winter and occurs throughout the year in the elderly or patients suffering from autoimmune diseases. The objective of this study was to evaluate the pharmacokinetic properties of oral supplementation versus a single intramuscular injection of cholecalciferol in healthy individuals.Up to 8,000 I.U. oral cholecalciferol was administered daily for 84 days in a 4 week dose-escalation setting to vitamin D deficient individuals. In another cohort, a single intramuscular injection of 100,000 I.U. cholecalciferol was given. In both cohorts, individuals without vitamin D intake served as the comparison group. 25-hydroxyvitamin D (25(OHD concentrations were measured in all individuals at defined time points throughout the studies.The mean 25(OHD serum concentration increased significantly after oral cholecalciferol intake compared to the control group (day 28: 83.4 nmol/l and 42.5 nmol/l; day 56: 127.4 nmol/l and 37.3 nmol/l; day 84: 159.7 nmol/l and 30.0 nmol/l. In individuals receiving 100,000 I.U. cholecalciferol intramuscular, the mean 25(OHD serum concentration peaked after 4 weeks measuring 70.9 nmol/l compared to 32.7 nmol/l in the placebo group (p = 0.002. The increase of 25(OHD serum concentrations after 28 days was comparable between both routes of administration (p = 0.264.Oral and intramuscular cholecalciferol supplementation effectively increased serum 25(OHD concentrations.

  20. Single-dose intravenous iron infusion or oral iron for treatment of fatigue after postpartum haemorrhage

    DEFF Research Database (Denmark)

    Holm, C; Thomsen, L L; Norgaard, A

    2017-01-01

    -label, randomized controlled trial. Participants received intravenous iron (n = 97) or oral iron (n = 99), and completed the Multidimensional Fatigue Inventory and Edinburgh Postnatal Depression Scale, and haematological and iron parameters were measured. Primary outcome was the aggregated change in physical...

  1. 77 FR 41415 - Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration...

    Science.gov (United States)

    2012-07-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0563... Labeled for Human Use; Enforcement Action Dates; Correction AGENCY: Food and Drug Administration, HHS... contain oxycodone hydrochloride for oral administration and are labeled for human use, and persons who...

  2. Measurement of testosterone: how important is a morning blood draw?

    Science.gov (United States)

    Crawford, E David; Poage, Wendy; Nyhuis, Allen; Price, David A; Dowsett, Sherie A; Gelwicks, Steven; Muram, David

    2015-01-01

    Since testosterone levels exhibit a circadian variation with peak levels in the morning, evidence-based guidelines recommend measuring morning total testosterone (TT) levels as the initial diagnostic test for androgen deficiency. However, it has been suggested that morning blood draw may not be necessary in older men due to a blunted circadian rhythm. We sought to determine whether it is possible to expand the morning sampling window for measurement of TT. TT levels were measured in a subset of men (mean age of 61 years) participating in the 2013 Prostate Cancer Awareness Week. TT levels measured in blood drawn from 8 to 11 AM (n = 229) differed significantly from those drawn outside this window (n = 442) (411.7 vs 368.3 ng/dl; p = 0.0003). Differences in TT levels were evident across five blood draw time windows (p = < 0.0001) and persisted after adjustment for age and BMI. TT levels in blood drawn from 2 to 5 PM (344.3 ng/dl) and 5 to 8 PM (334.4 ng/dl) differed significantly from that drawn from 8 to 11 AM (p < 0.05), while TT levels from 11 AM to 2 PM (396.5 ng/dl) and 8 PM to 8 AM (373.4 ng/dl) did not (p = 0.90 and 0.73, respectively). Based on these findings, it may be possible to expand the blood draw time window for measurement of serum TT. This community-based study was not prospectively design to determine the most appropriate blood draw window for TT measurement. Only a single TT measurement was made without consideration for day-to-day variability, and TT levels were not measured in the same men at different blood draw times.

  3. Single dose oral azithromycin versus seven day doxycycline in the treatment of non-gonococcal mucopurulent endocervicitis.

    Science.gov (United States)

    Sendağ, F; Terek, C; Tuncay, G; Ozkinay, E; Güven, M

    2000-02-01

    The aim of this study was to compare single dose oral azithromycin versus seven-day doxycycline in the treatment of non-gonococcal mucopurulent cervicitis (MPC). One hundred and thirty-one women with non-gonococcal MPC were enrolled in a prospective-randomised study to compare the efficacy and safety of a single oral dose of 1 g azithromycin and a seven-day course of 100 mg doxycycline twice daily. Clinical examination and culture samples for Chlamydia trachomatis and other microorganisms were performed before and approximately 14 days after starting the treatment. Of the 131 women recruited (67 in the azithromycin group and 64 in the doxycycline group), Ureaplasma urealyticum was isolated from 21 (16%); Chlamydia trachomatis from 15 (11.5%); and Mycoplasma hominis from 3 (2.3%) of the patients at the initial examination. The eradication rate of baseline culture-positive cases at the follow-up visit in the azithromycin group was 71.4%, and 77.3% in the doxycycline group. There was no statistically significant difference in efficacy between the single dose azithromycin and seven-day course of doxycycline in the treatment of culture-positive cases. Azithromycin 1 g appears to be an effective and safe alternative to doxycycline for the treatment of non-gonococcal MPC.

  4. Physical activity in the morning and afternoon is lower in patients with chronic obstructive pulmonary disease with morning symptoms.

    Science.gov (United States)

    van Buul, Amanda R; Kasteleyn, Marise J; Chavannes, Niels H; Taube, Christian

    2018-03-27

    Patients with chronic obstructive pulmonary disease (COPD) experience symptoms that vary over the day. Symptoms at the start of the day might influence physical activity during the rest of the day. Therefore, physical activity during the course of the day was studied in patients with low and high morning symptom scores. This cross-sectional observational study included patients with moderate to very severe COPD. Morning symptoms were evaluated with the PRO-morning COPD Symptoms Questionnaire (range 0-60); the median score was used to create two groups (low and high morning symptom scores). Physical activity was examined with an accelerometer. Activity parameters during the night, morning, afternoon and evening were compared between patients with low and high morning symptom scores using independent t-tests or Mann-Whitney U tests. Seventy nine patients were included. Patients were aged (mean ± SD) 65.6 ± 8.8 years with a mean forced expiratory volume in 1 s of 55 ± 17%predicted. Patients with low morning symptom scores (score morning (p = 0.030). There were no significant differences during the evening and night. Patients with high morning symptom scores took significantly fewer steps in the morning and afternoon than those with low morning symptom scores. Prospective studies are needed to prove causality between morning symptoms and physical activity during different parts of the day.

  5. Basal encephalocele and morning glory syndrome.

    Science.gov (United States)

    Caprioli, J; Lesser, R L

    1983-01-01

    Basal encephaloceles are often associated with other midline anomalies such as hypertelorism, broad nasal root, cleft lip, and cleft palate. Optic disc anomalies such as pallor, dysplasia, optic pit, coLoboma, and megalopapilla have been reported to occur in patients with basal encephalocele We report a case of a child with a sphenoethmoidal encephalocele and morning glory syndrome of the optic nerve. The presence of such optic nerve anomalies with facial midline anomalies should alert the clinician to the possible presence of a basal encephalocele. Images PMID:6849854

  6. Morning blood pressure monitoring in the management of hypertension.

    Science.gov (United States)

    Wang, Ji-Guang; Kario, Kazuomi; Park, Jeong-Bae; Chen, Chen-Huan

    2017-08-01

    : The aim of the current article is to review the current evidence on the role of morning blood pressure (BP) in the management of hypertension. Morning BP surge had been and will continue to be a hot topic of hypertension research. However, more evidence is needed to prove its clinical usefulness in the management of hypertension. Masked morning hypertension, as the other forms of masked hypertension, requires more research. The concept of morning BP monitoring could be clinically relevant in the therapeutic management of hypertension and in the prevention of cardiovascular complications by defining and treating morning hypertension. Antihypertensive medication is usually taken in the morning. The presence of uncontrolled morning BP during trough effect hours could be a hallmark of inadequate antihypertensive regimen, such as, for instance, the use of short-acting or intermediate-acting drugs, under dosing of drugs, or no or low use of combination therapy. To improve the management of hypertension in general and morning hypertension in particular, long-acting antihypertensive drugs should be used in appropriate often full dosages and in proper combinations. The clinical usefulness of antihypertensive drugs of specific mechanisms against morning BP or split or timed dosing of long-acting drugs in controlling morning BP remains under investigation. In conclusion, there is some evidence that morning BP is critical in the incidence of cardiovascular complications. However, proving its clinical usefulness in the management of hypertension requires further research.

  7. Resin Glycosides from the Morning Glory Family

    Science.gov (United States)

    Pereda-Miranda, Rogelio; Rosas-Ramírez, Daniel; Castañeda-Gómez, Jhon

    Resin glycosides are part of a very extensive family of secondary metabolites known as glycolipids or lipo-oligosaccharides and are constituents of complex resins (glycoresins) (1) unique to the morning glory family, Convolvulaceae (2). These active principles are responsible for the drastic purgative action of all the important Convolvulaceous species used in traditional medicine throughout the world since ancient times. Several commercial purgative crude drugs can be prepared from the roots of different species of Mexican morning glories. Their incorporation as therapeutic agents in Europe is an outstanding example of the assimilation of botanical drugs from the Americas as substitutes for traditional Old World remedies (3). Even though phytochemical investigations on the constituents of these drugs were initiated during the second half of the nineteenth century, the structure of their active ingredients still remains poorly known for some examples of these purgative roots. During the last two decades, the higher resolution capabilities of modern analytical isolation techniques used in conjunction with powerful spectroscopic methods have facilitated the elucidation of the active principles of these relevant herbal products.

  8. Phylogenetic group- and species-specific oligonucleotide probes for single-cell detection of lactic acid bacteria in oral biofilms

    Science.gov (United States)

    2011-01-01

    Background The purpose of this study was to design and evaluate fluorescent in situ hybridization (FISH) probes for the single-cell detection and enumeration of lactic acid bacteria, in particular organisms belonging to the major phylogenetic groups and species of oral lactobacilli and to Abiotrophia/Granulicatella. Results As lactobacilli are known for notorious resistance to probe penetration, probe-specific assay protocols were experimentally developed to provide maximum cell wall permeability, probe accessibility, hybridization stringency, and fluorescence intensity. The new assays were then applied in a pilot study to three biofilm samples harvested from variably demineralized bovine enamel discs that had been carried in situ for 10 days by different volunteers. Best probe penetration and fluorescent labeling of reference strains were obtained after combined lysozyme and achromopeptidase treatment followed by exposure to lipase. Hybridization stringency had to be established strictly for each probe. Thereafter all probes showed the expected specificity with reference strains and labeled the anticipated morphotypes in dental plaques. Applied to in situ grown biofilms the set of probes detected only Lactobacillus fermentum and bacteria of the Lactobacillus casei group. The most cariogenic biofilm contained two orders of magnitude higher L. fermentum cell numbers than the other biofilms. Abiotrophia/Granulicatella and streptococci from the mitis group were found in all samples at high levels, whereas Streptococcus mutans was detected in only one sample in very low numbers. Conclusions Application of these new group- and species-specific FISH probes to oral biofilm-forming lactic acid bacteria will allow a clearer understanding of the supragingival biome, its spatial architecture and of structure-function relationships implicated during plaque homeostasis and caries development. The probes should prove of value far beyond the field of oral microbiology, as many of

  9. Phylogenetic group- and species-specific oligonucleotide probes for single-cell detection of lactic acid bacteria in oral biofilms

    Directory of Open Access Journals (Sweden)

    Thurnheer Thomas

    2011-01-01

    Full Text Available Abstract Background The purpose of this study was to design and evaluate fluorescent in situ hybridization (FISH probes for the single-cell detection and enumeration of lactic acid bacteria, in particular organisms belonging to the major phylogenetic groups and species of oral lactobacilli and to Abiotrophia/Granulicatella. Results As lactobacilli are known for notorious resistance to probe penetration, probe-specific assay protocols were experimentally developed to provide maximum cell wall permeability, probe accessibility, hybridization stringency, and fluorescence intensity. The new assays were then applied in a pilot study to three biofilm samples harvested from variably demineralized bovine enamel discs that had been carried in situ for 10 days by different volunteers. Best probe penetration and fluorescent labeling of reference strains were obtained after combined lysozyme and achromopeptidase treatment followed by exposure to lipase. Hybridization stringency had to be established strictly for each probe. Thereafter all probes showed the expected specificity with reference strains and labeled the anticipated morphotypes in dental plaques. Applied to in situ grown biofilms the set of probes detected only Lactobacillus fermentum and bacteria of the Lactobacillus casei group. The most cariogenic biofilm contained two orders of magnitude higher L. fermentum cell numbers than the other biofilms. Abiotrophia/Granulicatella and streptococci from the mitis group were found in all samples at high levels, whereas Streptococcus mutans was detected in only one sample in very low numbers. Conclusions Application of these new group- and species-specific FISH probes to oral biofilm-forming lactic acid bacteria will allow a clearer understanding of the supragingival biome, its spatial architecture and of structure-function relationships implicated during plaque homeostasis and caries development. The probes should prove of value far beyond the field of

  10. Single Exposure of Human Oral Mucosa Fibroblasts to Ultraviolet B Radiation Reduces Proliferation and Induces COX-2 Expression and Activation

    Directory of Open Access Journals (Sweden)

    Y Boza

    2010-12-01

    Full Text Available The lip vermillion constitutes a transition tissue, between oral mucosa and skin, where oral mucosal cells from epithelial and connective tissue compartments are exposed to ultraviolet (UV sunlight. Fibroblasts are abundant resident cells of the connective tissue which are key regulators of extracellular matrix composition, as well as, epithelial and endothelial cell function. UVB light, an inherent component of sunlight, causes several alterations in skin fibroblasts, including premature senescence and increased cyclooxygenase (COX-2 expression. To assess if UVB irradiation had similar effects on fibroblasts derived from human oral mucosa (HOM, primary cultures of HOM fibroblasts were irradiated with a single dose of 30 or 60 mJ/cm²of UVB light or sham-irradiated. Fibroblast proliferation was assessed from 3 to 48 hrs after UVB-irradiation utilizing [³H]-thymidine incorporation and MTT assays. In addition, COX-2 mRNA expression was detected by RT-PCR, and PGE2 production was assessed using enzyme immunoassay from 0.5 to 24 hrs after UVB-irradiation. The results showed a significant decrease in proliferation of UVB-irradiated HOM fibroblasts as compared to controls as measured by both [³H]-thymidine incorporation and MTT assays (p<0.001. HOM fibroblasts had increased COX-2 mRNA expression at 0.5 and 12 hrs after irradiation, and PGE2 production was elevated at 12 and 24 hrs post-irradiation as compared to controls (p<0.05. The results showed an inhibitory effect of a single dose of UVB irradiation on HOM fibroblast proliferation with an increase in COX-2 expression and activation. Therefore, photodamaged fibroblasts may play and important role in the pathogenesis of UV-induced lesions of the lip.

  11. A single dose of sodium nitrate does not improve oral glucose tolerance in patients with type 2 diabetes mellitus.

    Science.gov (United States)

    Cermak, Naomi M; Hansen, Dominique; Kouw, Imre W K; van Dijk, Jan-Willem; Blackwell, Jamie R; Jones, Andrew M; Gibala, Martin J; van Loon, Luc J C

    2015-08-01

    Dietary nitrate (NO3(-)) supplementation has been proposed as an emerging treatment strategy for type 2 diabetes. We hypothesized that ingestion of a single bolus of dietary NO3(-) ingestion improves oral glucose tolerance in patients with type 2 diabetes. Seventeen men with type 2 diabetes (glycated hemoglobin, 7.3% ± 0.2%) participated in a randomized crossover experiment. The subjects ingested a glucose beverage 2.5 hours after consumption of either sodium NO3(-) (0.15 mmol NaNO3(-) · kg(-1)) or a placebo solution. Venous blood samples were collected before ingestion of the glucose beverage and every 30 minutes thereafter during a 2-hour period to assess postprandial plasma glucose and insulin concentrations. The results show that plasma NO3(-) and nitrite levels were increased after NaNO3(-) as opposed to placebo ingestion (treatment-effect, P = .001). Despite the elevated plasma NO3(-) and nitrite levels, ingestion of NaNO3(-) did not attenuate the postprandial rise in plasma glucose and insulin concentrations (time × treatment interaction, P = .41 for glucose, P = .93 for insulin). Despite the lack of effect on oral glucose tolerance, basal plasma glucose concentrations measured 2.5 hours after NaNO3(-) ingestion were lower when compared with the placebo treatment (7.5 ± 0.4 vs 8.3 ± 0.4 mmol/L, respectively; P = .04). We conclude that ingestion of a single dose of dietary NO3(-) does not improve subsequent oral glucose tolerance in patients with type 2 diabetes. Copyright © 2015 Elsevier Inc. All rights reserved.

  12. Population pharmacokinetics of a single dose of meloxicam after oral and intramuscular administration to captive lesser flamingos (Phoeniconaias minor).

    Science.gov (United States)

    Zordan, Martín A; Papich, Mark G; Pich, Ashley A; Unger, Katy M; Sánchez, Carlos R

    2016-12-01

    OBJECTIVE To determine the pharmacokinetics of a single dose of meloxicam after IM and oral administration to healthy lesser flamingos (Phoeniconaias minor) by use of a population approach. ANIMALS 16 healthy captive lesser flamingos between 1 and 4 years of age. PROCEDURES A single dose of meloxicam (0.5 mg/kg) was administered IM to each bird, and blood samples were collected from birds at 3 (n = 13 birds), 2 (2), or 1 (1) selected point between 0 and 13 hours after administration, with samples collected from birds at each point. After a 15-day washout period, the same dose of meloxicam was administered PO via a red rubber tube and blood samples were collected as described for IM administration. Pharmacokinetic values were determined from plasma concentrations measured by high-performance liquid chromatography. RESULTS Plasma drug concentrations after IM administration of meloxicam reached a mean ± SD maximum value of 6.01 ± 3.38 μg/mL. Mean area under the concentration-versus-time curve was 17.78 ± 2.79 μg•h/mL, and mean elimination half-life was 1.93 ± 0.32 hours. Plasma concentrations after oral administration reached a mean maximum value of 1.79 ± 0.33 μg/mL. Mean area under the curve was 22.16 ± 7.17 μg•h/mL, and mean elimination half-life was 6.05 ± 3.53 hours. CONCLUSIONS AND CLINICAL RELEVANCE In lesser flamingos, oral administration of meloxicam resulted in higher bioavailability and a longer elimination half-life than did IM administration, but the maximum plasma concentration was low and may be insufficient to provide analgesia in flamingos. Conversely, IM administration achieved the desired plasma concentration but would require more frequent administration.

  13. DNA damage in rats after a single oral exposure to diesel exhaust particles

    DEFF Research Database (Denmark)

    Danielsen, Pernille Høgh; Risom, Lotte; Wallin, Håkan

    2008-01-01

    The gastrointestinal route of exposure to particulate matter is important because particles are ingested via contaminated foods and inhaled particles are swallowed when removed from the airways by the mucociliary clearance system. We investigated the effect of an intragastric administration by oral...... gavage of diesel exhaust particles (DEP) in terms of DNA damage, oxidative stress and DNA repair in colon epithelial cells, liver, and lung of rats. Eight rats per group were exposed to Standard Reference Material 2975 at 0.064 or 0.64 mg/kg bodyweight for 6 and 24 h. Increased levels of 8-oxo-7...

  14. Morning surge in blood pressure using a random-effects multiple-component cosinor model.

    Science.gov (United States)

    Madden, J M; Browne, L D; Li, X; Kearney, P M; Fitzgerald, A P

    2018-01-29

    Blood pressure (BP) fluctuates throughout the day. The pattern it follows represents one of the most important circadian rhythms in the human body. For example, morning BP surge has been suggested as a potential risk factor for cardiovascular events occurring in the morning, but the accurate quantification of this phenomenon remains a challenge. Here, we outline a novel method to quantify morning surge. We demonstrate how the most commonly used method to model 24-hour BP, the single cosinor approach, can be extended to a multiple-component cosinor random-effects model. We outline how this model can be used to obtain a measure of morning BP surge by obtaining derivatives of the model fit. The model is compared with a functional principal component analysis that determines the main components of variability in the data. Data from the Mitchelstown Study, a population-based study of Irish adults (n = 2047), were used where a subsample (1207) underwent 24-hour ambulatory blood pressure monitoring. We demonstrate that our 2-component model provided a significant improvement in fit compared with a single model and a similar fit to a more complex model captured by b-splines using functional principal component analysis. The estimate of the average maximum slope was 2.857 mmHg/30 min (bootstrap estimates; 95% CI: 2.855-2.858 mmHg/30 min). Simulation results allowed us to quantify the between-individual SD in maximum slopes, which was 1.02 mmHg/30 min. By obtaining derivatives we have demonstrated a novel approach to quantify morning BP surge and its variation between individuals. This is the first demonstration of cosinor approach to obtain a measure of morning surge. Copyright © 2018 John Wiley & Sons, Ltd.

  15. The single dose pharmacokinetic profile of a novel oral human parathyroid hormone formulation in healthy postmenopausal women.

    Science.gov (United States)

    Hämmerle, Sibylle P; Mindeholm, Linda; Launonen, Aino; Kiese, Beate; Loeffler, Rolf; Harfst, Evita; Azria, Moise; Arnold, Michel; John, Markus R

    2012-04-01

    Parathyroid hormone (PTH), currently the only marketed anabolic treatment for osteoporosis, is available as the full-length hormone, human PTH1-84, or as the human PTH1-34 fragment (teriparatide). Both must be administered as a daily subcutaneous (sc) injection. A new oral formulation of human PTH1-34 (PTH134) is being developed as a more convenient option for patients. In this single-center, partially-blinded, incomplete cross-over study, the safety, tolerability, and exposure of oral PTH134 (teriparatide combined with 2 different quantities of the absorption enhancer 5-CNAC) were assessed in 32 healthy postmenopausal women. 16 subjects were randomized to receive 4 single doses out of 6 different treatments: placebo, teriparatide 20 μg sc, or 1, 2.5, 5 or 10 mg of oral PTH134 formulated with 200 mg 5-CNAC. Subsequently, another 16 subjects were randomized to receive 4 out of 6 different treatments: placebo, teriparatide 20 μg sc, or 2.5 or 5 mg of oral PTH134 formulated with either 100 or 200 mg 5-CNAC. Doses were given ≥6 days apart. All doses of PTH134 were rapidly absorbed, and showed robust blood concentrations in a dose-dependent manner. Interestingly, PTH1-34 disappeared from blood faster after oral than after sc administration. Specifically, 2.5 and 5 mg PTH134 (containing 200 mg 5-CNAC) demonstrated Cmax and AUC0-last values closest to those of sc teriparatide 20 μg (Forsteo®). Mean+/-SD hPTH134 Cmax values were, respectively, 74+/-59, 138+/-101, 717+/-496, and 1624+/-1579 pg/mL for 1, 2.5, 5, and 10 mg doses of this peptide administered with 200 mg 5-CNAC; while mean+/-SD AUC (0-last) values were, respectively, 30+/-40, 62+/-69, 320+/-269, and 627+/-633 h*pg/mL. The corresponding estimates for teriparatide 20 μg sc were 149+/-35 for Cmax and 236+/-58 for AUC (0-last) Ionized calcium remained within normal limits in all treatment groups except for 3 isolated events. Nine subjects withdrew due to treatment-related AEs. Of those, seven were taking PTH

  16. Cytokine gene associations with self-report ratings of morning and evening fatigue in oncology patients and their family caregivers.

    Science.gov (United States)

    Dhruva, Anand; Aouizerat, Bradley E; Cooper, Bruce; Paul, Steven M; Dodd, Marylin; West, Claudia; Wara, William; Lee, Kathryn; Dunn, Laura B; Langford, Dale J; Merriman, John D; Baggott, Christina; Cataldo, Janine; Ritchie, Christine; Kober, Kord M; Leutwyler, Heather; Miaskowski, Christine

    2015-03-01

    The purpose of this study was to evaluate for differences in variations in pro- and anti-inflammatory cytokine genes between participants who were classified as having low and high levels of morning and evening fatigue and to evaluate for differences in phenotypic characteristics between these two groups. In a sample of 167 oncology outpatients with breast, prostate, lung, or brain cancer and 85 of their family caregivers, growth mixture modeling was used to identify latent classes of individuals based on ratings of morning and evening fatigue obtained prior to, during, and for 4 months following completion of radiation therapy. Differences in single nucleotide polymorphisms and haplotypes in 15 cytokine genes were evaluated between the latent classes. Multiple logistic regression was used to assess the effect of phenotypic and genotypic characteristics on morning and evening fatigue class membership. Associations were found between morning fatigue and number of comorbidities as well as variations in tumor necrosis factor alpha (TNFA) rs1800629 and rs3093662. Evening fatigue was associated with caring for children at home and variations in interleukin 4 (IL4) rs2243248 and TNFA rs2229094. Younger age and lower performance status were associated with both morning and evening fatigue. These findings suggest that inflammatory mediators are associated with the development of morning and evening fatigue. However, because different phenotypic characteristics and genomic markers are associated with diurnal variations in fatigue, morning and evening fatigue may be distinct but related symptoms. © The Author(s) 2014.

  17. Results of single and repeat dose studies of the oral matrix metalloproteinase inhibitor marimastat in healthy male volunteers

    Science.gov (United States)

    Millar, Andrew W; Brown, Peter D; Moore, Jeff; Galloway, W Alan; Cornish, Alan G; Lenehan, Terence J; Lynch, Kevin P

    1998-01-01

    Aims To assess the tolerability and pharmacokinetic profile of single and repeat doses of the oral matrix metalloproteinase inhibitor marimastat in healthy male volunteers. Methods A total of 31 subjects participated in two placebo-controlled, rising-dose studies. The first study assessed the pharmacokinetics and tolerability of single doses of marimastat of 25, 50, 100, 200, 400 and 800 mg. In the second study, continuous dosing over 6.5 days with three incremental dose levels of 50, 100 and 200 mg twice daily was assessed. Full pharmacokinetic profiles were obtained on days 0 and 6, and trough concentrations were measured on all days. For each pharmacokinetic profile in the studies, summary measures including Cmax, tmax, elimination half-life and AUC were calculated. Urinary drug weights were also measured. All adverse events were documented, and haematological and biochemical variables, vital signs and ECGs were monitored throughout the study. Results Peak plasma concentrations were observed at 1.5–3 h for all subjects at all doses. Peak levels were approximately proportional to dose, as was drug exposure as calculated by AUC. Data from both studies indicate that the terminal elimination half-life is of the order of 8–10 h, and that there is no unexpected drug accumulation. Marimastat was well-tolerated, with adverse effects being mild and occurring with similar frequency to placebo. Small but reversible elevations in liver transaminases were noted with repeat dosing of marimastat, the most significant of these occurring at a dose of 200 mg twice daily. Conclusion Single and repeat oral doses of marimastat in healthy male subjects appear to be well-tolerated. The drug is rapidly absorbed with high peak levels achieved. It has a terminal elimination half-life of 8–10 h which would support twice daily dosing in further clinical trials. PMID:9489589

  18. Water content of faeces is higher in the afternoon than in the morning in morning-fed dogs fed diets containing texturised vegetable protein from soya.

    Science.gov (United States)

    Hill, Richard C; Burrows, Colin F; Ellison, Gary W; Finke, Mark D; Huntington, Jennifer L; Bauer, John E

    2011-10-01

    Faecal moisture content can determine whether faeces appear soft or firm, and faecal character can influence whether owners are satisfied with a dog food. In a previous study, dogs appeared to produce softer faeces after noon. The purpose of the present study was to determine whether time of defecation affected canine faecal water content. A total of eight hound dogs were fed one of four canned diets as a single meal each morning for 1 week per diet in a Latin square design. All four diets contained approximately 77 % moisture and, on a DM basis, 24 MJ/kg gross energy, 23 % crude protein, 32 % crude fat, 31 % N-free extract and 1 % crude fibre. The proportion of dietary protein from soya-derived texturised vegetable protein (TVP):beef was 0:100, 14:86, 29:71 and 57:43, respectively. Soya carbohydrate partially replaced maize starch as TVP increased. Faeces were collected by direct catch during the sixth morning and afternoon of each diet period. Mean faecal moisture content was greater in the afternoon than in the morning (79 v. 71 %; P = 0.01) and increased with dietary TVP (P ≤ 0.0001), and there was an interaction between time of day and percentage TVP (P = 0.003). Faecal moisture content differed from morning to afternoon only with TVP in the diet. Faecal wet weight was similar from morning to afternoon. This suggests that time of day and presence of TVP from soya should be taken into account when evaluating the effect of a diet on faecal form and moisture content in dogs fed once daily.

  19. Oxidatively damaged DNA in rats exposed by oral gavage to C60 fullerenes and single-walled carbon nanotubes

    DEFF Research Database (Denmark)

    Folkmann, Janne K; Risom, Lotte; Jacobsen, Nicklas R

    2009-01-01

    BACKGROUND: C60 fullerenes and single-walled carbon nanotubes (SWCNT) are projected to be used in medicine and consumer products with potential human exposure. The hazardous effects of these particles are expected to involve oxidative stress with generation of oxidatively damaged DNA that might......, liver, and lung of rats after intragastric administration of pristine C60 fullerenes or SWCNT (0.064 or 0.64 mg/kg body weight) suspended in saline solution or corn oil. We investigated the regulation of DNA repair systems toward 8-oxodG in liver and lung tissue. RESULTS: Both doses of SWCNT increased...... of genotoxicity, whereas corn oil per se generated more genotoxicity than the particles. Although there was increased mRNA expression of 8-oxoguanine DNA glycosylase in the liver of C60 fullerene-treated rats, we found no significant increase in repair activity. CONCLUSIONS: Oral exposure to low doses of C60...

  20. Pharmacokinetics and Safety of Tedizolid after Single and Multiple Intravenous/Oral Sequential Administrations in Healthy Chinese Subjects.

    Science.gov (United States)

    Chen, Rui; Shen, Kai; Chang, Xinying; Tanaka, Toshiaki; Li, Li; Hu, Pei

    2016-08-01

    Tedizolid phosphate is a new antibacterial agent under investigation for the treatment of Gram-positive infections in China. This study was conducted to assess the pharmacokinetic (PK) properties, oral bioavailability, and safety of once daily tedizolid phosphate 200 mg in Chinese subjects to support its further clinical development in China. This Phase I single-center study, conducted in 16 healthy Chinese male subjects, consisted of a single-dose administration, 1:1 randomized, two-way, intravenous (IV)/oral (PO) crossover of tedizolid phosphate 200 mg (Part 1) and, after a 7-day washout, a nonrandomized, multiple-dose, 7-day tedizolid phosphate 200 mg once daily administration (IV for 3 days, PO for 4 days; Part 2). Blood samples were collected for up to 72 hours after single dosing and for up to 2 hours on Day 3 and 72 hours on Day 7 of multiple dosing to determine PK parameters. Adverse events (AEs) were recorded throughout the entire study. The Cmax and AUC of tedizolid (the active moiety of tedizolid phosphate) were 3.02 µg/mL and 30.50 µg • h/mL after single IV dosing of tedizolid phosphate, and 2.25 µg/mL and 26.10 µg • h/mL after single PO dosing, respectively, and the mean half-life was 10.1 hours for both administration routes. The oral bioavailability of tedizolid was 85.5%. PK parameters of tedizolid were similar after single and multiple dosing of tedizolid phosphate, indicating no time dependency. Only minor accumulation of tedizolid was observed after multiple dosing (expressed as accumulation ratios RAAUC: 1.18 for PO dosing, and RACmax: 1.16 and 1.05 for IV and PO dosing, respectively). Steady state of tedizolid was reached after about 3 days, and trough concentrations remained constant when switching from IV to PO dosing. Tedizolid phosphate was well tolerated with 6 subjects (37.5%) in Part 1 and 5 subjects (31.3%) in Part 2 experiencing an AE; all AEs but one were related to the study drug assessed by the investigator. All AEs were of

  1. The effect of food composition on serum testosterone levels after oral administration of Andriol? Testocaps?

    OpenAIRE

    Schnabel, Peter G; Bagchus, Wilma; Lass, Holger; Thomsen, Torben; Geurts, T B Paul

    2007-01-01

    Objective Andriol? Testocaps? is a new oral formulation of testosterone undecanoate (TU) for treatment of hypogonadism. As TU is taken up by the intestinal lymphatic system, both the presence and the composition of food influence the absorption. The aim of this study was to investigate the effect of food composition on the pharmacokinetics of oral TU. Design An open-label, single-centre, four-way crossover study. With a washout period of 6?7 days, 80 mg TU was administered in the morning 5 mi...

  2. Evaluation of sphingolipids in Wistar rats treated to prolonged and single oral doses of fumonisin b₁.

    Science.gov (United States)

    Direito, Glória M; Almeida, Adriana P; Aquino, Simone; dos Reis, Tatiana Alves; Pozzi, Claudia Rodrigues; Corrêa, Benedito

    2009-01-01

    The objective of the present study was to evaluate sphingolipid levels (sphingosine-So and sphinganine-Sa) and to compare the Sa/So ratio in liver, serum and urine of Wistar rats after prolonged administration (21 days) of fumonisin B(1) (FB(1)). In parallel, the kinetics of sphingolipid elimination in urine was studied in animals receiving a single dose of FB(1). Prolonged exposure to FB(1) caused an increase in Sa levels in urine, serum and liver. The most marked effect on sphingolipid biosynthesis was observed in animals treated with the highest dose of FB(1). Animals receiving a single dose of FB(1) presented variations in Sa and So levels and in the Sa/So ratio.

  3. Skin and soft tissue concentrations of tedizolid (formerly torezolid), a novel oxazolidinone, following a single oral dose in healthy volunteers.

    Science.gov (United States)

    Sahre, Martina; Sabarinath, Sreedharan; Grant, Maria; Seubert, Christoph; Deanda, Carisa; Prokocimer, Philippe; Derendorf, Hartmut

    2012-07-01

    Plasma concentrations of antimicrobial drugs have long been used to correlate exposure with effect, yet one cannot always assume that unbound plasma and tissue concentrations are similar. Knowledge about unbound tissue concentrations is important in the development of antimicrobial drugs, since most infections are localised in tissues. Therefore, a clinical microdialysis study was conducted to evaluate the distribution of tedizolid (TR-700), the active moiety of the antimicrobial prodrug tedizolid phosphate (TR-701), into interstitial fluid (ISF) of subcutaneous adipose and skeletal muscle tissues following a single oral 600 mg dose of tedizolid phosphate in fasting conditions. Twelve healthy adult subjects were enrolled. Two microdialysis probes were implanted into the thigh of each subject, one into the vastus medialis muscle and one into subcutaneous adipose tissue. Probes were calibrated using retrodialysis. Dialysate samples were collected every 20 min for 12h following a single oral dose of 600 mg tedizolid phosphate, and blood samples were drawn over 24h. Unbound tedizolid levels in plasma were similar to those in muscle and adipose tissue. The ratios of unbound (free) AUC in tissues over unbound AUC in plasma (fAUC(tissue)/fAUC(plasma)) were 1.1 ± 0.2 and 1.2 ± 0.2 for adipose and muscle tissue, respectively. The median half-life was 8.1, 9.2 and 9.6h for plasma, adipose tissue and muscle tissue, respectively. Mean protein binding was 87.2 ± 1.8%. The study drug was very well tolerated. The results of this study show that tedizolid distributes well into ISF of adipose and muscle tissues. Unbound levels of tedizolid in plasma, adipose tissue and muscle tissue were well correlated. Free plasma levels are indicative of unbound levels in the ISF of muscle and adipose tissues. Copyright © 2012 Elsevier B.V. and the International Society of Chemotherapy. All rights reserved.

  4. Comparison of multi-modal early oral nutrition for the tolerance of oral nutrition with conventional care after major abdominal surgery: a prospective, randomized, single-blind trial.

    Science.gov (United States)

    Sun, Da-Li; Li, Wei-Ming; Li, Shu-Min; Cen, Yun-Yun; Xu, Qing-Wen; Li, Yi-Jun; Sun, Yan-Bo; Qi, Yu-Xing; Lin, Yue-Ying; Yang, Ting; Lu, Qi-Ping; Xu, Peng-Yuan

    2017-02-10

    Early oral nutrition (EON) has been shown to improve recovery of gastrointestinal function, length of stay and mortality after abdominal surgery; however, early oral nutrition often fails during the first week after surgery. Here, a multi-modal early oral nutrition program is introduced to promote recovery of gastrointestinal function and tolerance of oral nutrition. Consecutive patients scheduled for abdominal surgery were randomized to the multimodal EON group or a group receiving conventional care. The primary endpoint was the time of first defecation. The secondary endpoints were outcomes and the cost-effectiveness ratio in treating infectious complications. The rate of infectious-free patients was regarded as the index of effectiveness. One hundred seven patients were randomly assigned to groups. Baseline characteristics were similar for both groups. In intention-to-treat analysis, the success rate of oral nutrition during the first week after surgery in the multimodal EON group was 44 (83.0%) versus 31 (57.4%) in the conventional care group (P = 0.004). Time to first defecation, time to flatus, recovery time of bowel sounds, and prolonged postoperative ileus were all less in the multimodal EON group (P oral nutrition group (P oral nutrition program was an effective way to improve tolerance of oral nutrition during the first week after surgery, decrease the length of stay and improve cost-effectiveness after abdominal surgery. Registration number: ChiCTR-TRC-14004395 . Registered 15 March 2014.

  5. Laparoscopic Heller Myotomy vs Per Oral Endoscopic Myotomy: Patient-Reported Outcomes at a Single Institution.

    Science.gov (United States)

    Hanna, Andrew N; Datta, Jashodeep; Ginzberg, Sara; Dasher, Kevin; Ginsberg, Gregory G; Dempsey, Daniel T

    2018-02-01

    While laparoscopic Heller myotomy (LHM) has been tstandard of care for achalasia, per oral endoscopic myotomy (POEM) has gained popularity as a viable alternative. This retrospective study aims to compare patient reported outcomes between LHM and POEM in a consecutive series of achalasia patients with more than 1 year follow-up. Demographic and procedure-related data for patients who underwent either LHM or POEM for achalasia between January 2011 and May 2016 were reviewed. Phone interviews were conducted assessing post-procedure achalasia symptoms via the Eckardt score and Achalasia Severity Questionnaire (ASQ). Demographics, disease factors, and survey results were compared between LHM and POEM patients using univariate analysis. Significant predictors of procedure failure were analyzed using univariate and multivariate (MV) analysis. There were no serious complications in 110 consecutive patients who underwent LHM or POEM during the study period, and 96 (87%) patients completed phone surveys. There was a nonsignificant trend toward better patient reported outcomes with POEM. There were significant differences in patient characteristics including sex, achalasia type, mean residual lower esophageal pressure (rLESP), and follow up time. The only univariate predictors of an unsatisfactory Eckardt score or or ASQ were longer follow up and lower mLESP with follow up length being the only predictor on MV analysis. There are significant demographic and clinical differences in patient selection for POEM vs LHM in our group. While the two proceduress have similar patient-reported effectiveness, subjective outcomes seem to decline as a result of time rather than procedure type. Copyright © 2018. Published by Elsevier Inc.

  6. Pharmacokinetics of single oral dose of pimobendan in Hispaniolan Amazon parrots (Amazona ventralis).

    Science.gov (United States)

    Guzman, David Sanchez-Migallon; Beaufrère, Hugues; KuKanich, Butch; Barker, Steven A; Brandão, João; Paul-Murphy, Joanne; Tully, Thomas N

    2014-06-01

    Pimobendan is a phosphodiesterase (PDE) inhibitor and calcium sensitizer with inotropic, lusitropic, and rasodilator properties used in the treatment of congestive heart failure. The mechanism of action is by inhibition of PDE III and V and by increasing intracellular calcium sensitivity in the cardiac myocardium. Pharmacokinetic and pharmacodynamic studies have been published in humans, dogs, and cats, but there are no studies in avian species. Pimobendan has been used in birds at the empirical dosage of 0.25 mg/kg q12h. To determine the pharmacokinetic parameters of pimobendan in Hispaniolan Amazon parrots (Amazona ventralis), 3 pilot studies with 2 birds, each receiving 1, 3, and 10 mg/kg PO, provided the basis for the pivotal trials with 6 birds, each receiving 10 mg/kg PO using 2 different suspensions. Blood samples were obtained at 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, and 18 hours after drug administration. Plasma concentrations were determined by liquid chromatography-tandem mass spectrometry (HPLC/MS) by use of electrospray ionization. Because of the erratic and low concentrations of pimobendan, pharmacokinetic parameters were calculated using naive averaged analysis. Plasma concentrations after commercial pimobendan tablet suspension at 10 mg/kg reached a Cmax of 8.26 ng/mL at 3 hours with a terminal half-life of 2.1 hours, while concentrations after the bulk chemical suspension reached a Cmax of 1.28 ng/mL at 12 hours and had a terminal half-life of 2.3 hours. Further studies evaluating the effect of oral pimobendan in parrots are needed.

  7. A single 2 g oral dose of extended-release azithromycin for treatment of gonococcal urethritis.

    Science.gov (United States)

    Yasuda, Mitsuru; Ito, Shin; Kido, Akira; Hamano, Kiminari; Uchijima, Yutaka; Uwatoko, Noriyasu; Kusuyama, Hiroyuki; Watanabe, Akiko; Miyamura, Ryuzou; Miyata, Kazutoyo; Deguchi, Takashi

    2014-11-01

    We treated gonococcal urethritis in men with a single 2 g dose of azithromycin extended-release formulation (azithromycin-SR) to determine its microbiological outcomes and tolerability. We enrolled 189 Japanese men with gonococcal urethritis between April 2009 and December 2013. The patients were given a single 2 g dose of azithromycin-SR. Microbiological efficacy was evaluated by the results of the post-treatment molecular testing of Neisseria gonorrhoeae. MIC testing was performed only for pretreatment isolates of N. gonorrhoeae collected from the patients. We evaluated 130 patients for microbiological outcomes. Of these patients, 122 (93.8%) were judged to be microbiologically cured on the basis of negative test results. All isolates for which the azithromycin MICs were ≤0.25 mg/L were eradicated, whereas 5 of 12 isolates for which the MICs were 1 mg/L persisted after the treatment. Forty-six adverse events occurred in 41 patients. However, all adverse events were classified as mild. The eradication rate of N. gonorrhoeae was 93.8% in men with gonococcal urethritis treated with a single 2 g dose of azithromycin-SR. The breakpoint MIC of a 2 g dose of azithromycin-SR for gonococcal urethritis associated with clinical treatment failures appeared to be 1 mg/L. With regard to side effects of higher doses of azithromycin, the 2 g dose of azithromycin-SR appeared to improve tolerability. However, the widespread use of a high-dose regimen of azithromycin might lead to the development of further resistance to azithromycin. © The Author 2014. 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.

  8. Morning report: combining education with patient handover.

    Science.gov (United States)

    Sanfey, H; Stiles, B; Hedrick, T; Sawyer, R G

    2008-04-01

    The advent of resident work hour restrictions has challenged us to train residents within a shorter working week, while ensuring continuity of patient care. We instituted morning report (MR) at the University of Virginia primarily as a means to accomplish these objectives. Serendipitously MR has become an integral educational tool for the surgical residents. The rationale for the format and instructional design are discussed in the context of learning theory. The chief residents as primary stakeholders were strongly encouraged to play a leadership role in designing MR. A faculty- led didactic format was rejected because of the importance of focusing on resident team building, and leadership, but poor faculty participation was also an issue. The initial obstacles included timing, and designing the format. MR is an opportunity for residents to exercise and improve their knowledge, leadership, presentation and problem-solving skills. We would hypothesise that the advantages for teaching are many and include that residents are prepared for actual clinical problems in a supportive environment with opportunities for immediate feedback and assessment. Reports of educational effectiveness of MR are mostly anecdotal and further studies are needed to characterise the types of learning and teaching that occur during MR and to document educational effectiveness.

  9. Formulation of morning product using food residues

    Directory of Open Access Journals (Sweden)

    Maria do Rosário de Fátima Padilha

    2017-09-01

    Full Text Available In Brazil, there is resistance of the population to the use of stalks, leaves, peels and seeds of vegetables and fruits, leading to trash important parts of the food in good physiological conditions and with the presence of potential nutrients. In this research, a morning product was elaborated using green and dry coconut residue, jerimum and melon seed, crystallized sicilian lemon peel, cashew nut, common rapadura sweet and ginger. The bacteriological tests proved the hygienic-sanitary quality of the product, therefore suitable for consumption, that is, according to RDC 12/2001. It was also observed that the dehydration of all the residues reached the legal levels and accepted by ANVISA that limits in 25% the water content in the dehydrated foods. As for the centesimal composition, it was observed that the elaborated product with residues and other ingredients had a good content of macro nutrients. A use of the type of waste as a new food proposal constitutes an alternative to avoid and reduce: the serious environmental problem caused by the large residual volume generated, and the inadequate places in which they are stored or deposited, aggravating the scenario of food-borne pollutants.

  10. Tailoring Morning Reports to an Internal Medicine Residency in Qatar.

    Science.gov (United States)

    Dousa, Khalid Mohamed Ali; Muneer, Mohammed; Rahil, Ali; Al-Mohammed, Ahmed; AlMohanadi, Dabia; Elhiday, Abdelhaleem; Hamad, Abdelrahman; Albizreh, Bassim; Suliman, Noor; Muhsin, Saif

    2014-12-01

    Morning report, a case-based conference that allows learners and teachers to interact and discuss patient care, is a standard educational feature of internal residency programs, as well as some other specialties. Our intervention was aimed at enhancing the format for morning report in our internal medicine residency program in Doha, Qatar. In July 2011, we performed a needs assessment of the 115 residents in our internal medicine residency program, using a questionnaire. Resident input was analyzed and prioritized using the percentage of residents who agreed with a given recommendation for improving morning report. We translated the input into interventions that enhanced the format and content, and improved environmental factors surrounding morning report. We resurveyed residents using the questionnaire that was used for the needs assessment. Key changes to the format for morning report included improving organization, adding variety to the content, enhancing case selection and the quality of presentations, and introducing patient safety and quality improvement topics into discussions. This led to a morning report format that is resident-driven, and resident-led, and that produces resident-focused learning and quality improvement activities. Our revised morning report format is a dynamic tool, and we will continue to tailor and modify it on an ongoing basis in response to participant feedback. We recommend a process of assessing and reassessing morning report for other programs that want to enhance resident interest and participation in clinical and safety-focused discussions.

  11. Phase advancing human circadian rhythms with morning bright light, afternoon melatonin, and gradually shifted sleep: can we reduce morning bright-light duration?

    Science.gov (United States)

    Crowley, Stephanie J; Eastman, Charmane I

    2015-02-01

    Efficient treatments to phase-advance human circadian rhythms are needed to attenuate circadian misalignment and the associated negative health outcomes that accompany early-morning shift work, early school start times, jet lag, and delayed sleep phase disorder. This study compared three morning bright-light exposure patterns from a single light box (to mimic home treatment) in combination with afternoon melatonin. Fifty adults (27 males) aged 25.9 ± 5.1 years participated. Sleep/dark was advanced 1 h/day for three treatment days. Participants took 0.5 mg of melatonin 5 h before the baseline bedtime on treatment day 1, and an hour earlier each treatment day. They were exposed to one of three bright-light (~5000 lux) patterns upon waking each morning: four 30-min exposures separated by 30 min of room light (2-h group), four 15-min exposures separated by 45 min of room light (1-h group), and one 30-min exposure (0.5-h group). Dim-light melatonin onsets (DLMOs) before and after treatment determined the phase advance. Compared to the 2-h group (phase shift = 2.4 ± 0.8 h), smaller phase-advance shifts were seen in the 1-h (1.7 ± 0.7 h) and 0.5-h (1.8 ± 0.8 h) groups. The 2-h pattern produced the largest phase advance; however, the single 30-min bright-light exposure was as effective as 1 h of bright light spread over 3.25 h, and it produced 75% of the phase shift observed with 2 h of bright light. A 30-min morning bright-light exposure with afternoon melatonin is an efficient treatment to phase-advance human circadian rhythms. Copyright © 2014 Elsevier B.V. All rights reserved.

  12. Phase advancing human circadian rhythms with morning bright light, afternoon melatonin, and gradually shifted sleep: can we reduce morning bright light duration?

    Science.gov (United States)

    Crowley, Stephanie J.; Eastman, Charmane I.

    2015-01-01

    OBJECTIVE Efficient treatments to phase advance human circadian rhythms are needed to attenuate circadian misalignment and the associated negative health outcomes that accompany early morning shift work, early school start times, jet lag, and delayed sleep phase disorder. This study compared three morning bright light exposure patterns from a single light box (to mimic home treatment) in combination with afternoon melatonin. METHODS Fifty adults (27 males) aged 25.9±5.1 years participated. Sleep/dark was advanced 1 hour/day for 3 treatment days. Participants took 0.5 mg melatonin 5 hours before baseline bedtime on treatment day 1, and an hour earlier each treatment day. They were exposed to one of three bright light (~5000 lux) patterns upon waking each morning: four 30-minute exposures separated by 30 minutes of room light (2 h group); four 15-minute exposures separated by 45 minutes of room light (1 h group), and one 30-minute exposure (0.5 h group). Dim light melatonin onsets (DLMOs) before and after treatment determined the phase advance. RESULTS Compared to the 2 h group (phase shift=2.4±0.8 h), smaller phase advance shifts were seen in the 1 h (1.7±0.7 h) and 0.5 h (1.8±0.8 h) groups. The 2-hour pattern produced the largest phase advance; however, the single 30-minute bright light exposure was as effective as 1 hour of bright light spread over 3.25 h, and produced 75% of the phase shift observed with 2 hours of bright light. CONCLUSIONS A 30-minute morning bright light exposure with afternoon melatonin is an efficient treatment to phase advance human circadian rhythms. PMID:25620199

  13. Monolithic lithium-disilicate single crowns supported by zirconia oral implants: three-year results of a prospective cohort study.

    Science.gov (United States)

    Spies, Benedikt Christopher; Patzelt, Sebastian Berthold Maximilian; Vach, Kirstin; Kohal, Ralf-Joachim

    2016-09-01

    To determine the survival and success rate of CAD/CAM-fabricated monolithic lithium-disilicate crowns supported by zirconia oral implants after 3 years. Twenty-four patients in need of a single tooth replacement received a zirconia implant and were finally restored with 24 single crowns (SCs) ground out of pre-crystallized lithium-disilicate blanks. The restorations were adhesively cemented and evaluated using modified United States Public Health Service (USPHS) criteria. In case of clinically relevant defects that could be repaired to an acceptable level, SCs were regarded as surviving. Restorations with minor chippings, a small-area roughness (ø esthetics, sense, and speech. Monolithic lithium-disilicate SCs supported by zirconia implants showed promising survival and success rates after an observation period of 3 years. It remains to be seen whether the further observation period confirms this positive results. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  14. Does MRI with oral contrast medium allow single-study depiction of inflammatory bowel disease enteritis and colitis?

    Energy Technology Data Exchange (ETDEWEB)

    Cronin, Carmel G.; Lohan, Derek G.; Browne, Ann Michelle; Roche, Clare; Murphy, Joseph M. [University College Hospital, Department of Radiology, Galway (Ireland)

    2010-07-15

    To assess the feasibility and utility of magnetic resonance (MR) imaging of the bowel in concurrent small- and large-bowel evaluation for the presence of inflammatory bowel disease (IBD). Over a 5-year period, 62 MR examinations performed on 53 patients demonstrated evidence of IBD. Sixteen of these 53 (30.1%) patients had imaging findings of colonic disease and underwent 19 formal MR small bowel examinations. These were further evaluated for bowel distention and image quality. The sensitivity and specificity of the technique compared with colonoscopy as the 'gold standard' was evaluated. Simultaneous imaging of the colon is feasible at MR small bowel follow-through with moderate-to-excellent colonic visibility and colon distention obtained when the contrast medium is present in the colon at the time of image acquisition. MR imaging had a sensitivity of 80% (0.56-0.93), specificity of 100% (0.77-1.00), positive predictive value (PPV) of 1 and a negative predictive value (NPV) of 0.8 for the identification of colitis (based on available concurrent correlation of 38/62 examinations with colonoscopy). Small and large bowel MR imaging with orally consumed contrast medium represents a promising, feasible, non-invasive, non-radiating single mode of assessment of the entire gastrointestinal tract, performed at a single sitting. (orig.)

  15. Does MRI with oral contrast medium allow single-study depiction of inflammatory bowel disease enteritis and colitis?

    International Nuclear Information System (INIS)

    Cronin, Carmel G.; Lohan, Derek G.; Browne, Ann Michelle; Roche, Clare; Murphy, Joseph M.

    2010-01-01

    To assess the feasibility and utility of magnetic resonance (MR) imaging of the bowel in concurrent small- and large-bowel evaluation for the presence of inflammatory bowel disease (IBD). Over a 5-year period, 62 MR examinations performed on 53 patients demonstrated evidence of IBD. Sixteen of these 53 (30.1%) patients had imaging findings of colonic disease and underwent 19 formal MR small bowel examinations. These were further evaluated for bowel distention and image quality. The sensitivity and specificity of the technique compared with colonoscopy as the 'gold standard' was evaluated. Simultaneous imaging of the colon is feasible at MR small bowel follow-through with moderate-to-excellent colonic visibility and colon distention obtained when the contrast medium is present in the colon at the time of image acquisition. MR imaging had a sensitivity of 80% (0.56-0.93), specificity of 100% (0.77-1.00), positive predictive value (PPV) of 1 and a negative predictive value (NPV) of 0.8 for the identification of colitis (based on available concurrent correlation of 38/62 examinations with colonoscopy). Small and large bowel MR imaging with orally consumed contrast medium represents a promising, feasible, non-invasive, non-radiating single mode of assessment of the entire gastrointestinal tract, performed at a single sitting. (orig.)

  16. Population pharmacokinetics of artesunate and dihydroartemisinin following single- and multiple-dosing of oral artesunate in healthy subjects

    Directory of Open Access Journals (Sweden)

    Kirsch Lee E

    2009-12-01

    Full Text Available Abstract Background The population pharmacokinetics of artesunate (AS and its active metabolite dihydroartemisinin (DHA were studied in healthy subjects receiving single- or multiple-dosing of AS orally either in combination with pyronaridine (PYR or as a monotherapy with or without food. Methods Data from 118 concentration-time profiles arising from 91 healthy Korean subjects were pooled from four Phase I clinical studies. Subjects received 2-5 mg/kg of single- and multiple-dosing of oral AS either in combination with PYR or as a monotherapy with or without food. Plasma AS and DHA were measured simultaneously using a validated liquid chromatography- mass spectrometric method with a lower limit of quantification of 1 ng/mL for both AS and DHA. Nonlinear mixed-effect modelling was used to obtain the pharmacokinetic and variability (inter-individual and residual variability parameter estimates. Results A novel parent-metabolite pharmacokinetic model consisting of a dosing compartment, a central compartment for AS, a central compartment and a peripheral compartment for DHA was developed. AS and DHA data were modelled simultaneously assuming stoichiometric conversion to DHA. AS was rapidly absorbed with a population estimate of absorption rate constant (Ka of 3.85 h-1. The population estimates of apparent clearance (CL/F and volume of distribution (V2/F for AS were 1190 L/h with 36.2% inter-individual variability (IIV and 1210 L with 57.4% IIV, respectively. For DHA, the population estimates of apparent clearance (CLM/F and central volume of distribution (V3/F were 93.7 L/h with 28% IIV and 97.1 L with 30% IIV, respectively. The population estimates of apparent inter-compartmental clearance (Q/F and peripheral volume of distribution (V4/F for DHA were 5.74 L/h and 18.5 L, respectively. Intake of high-fat and high-caloric meal prior to the drug administration resulted in 84% reduction in Ka. Body weight impacted CLM/F, such that a unit change in

  17. The pharmacokinetic profile of crocetin in healthy adult human volunteers after a single oral administration.

    Science.gov (United States)

    Umigai, N; Murakami, K; Ulit, M V; Antonio, L S; Shirotori, M; Morikawa, H; Nakano, T

    2011-05-15

    Crocetin, a unique carotenoid with a short carbon chain length, is an active compound of saffron and Gardenia jasminoides Ellis used as traditional herbal medicine. The present study was undertaken to investigate the pharmacokinetic profiles of crocetin in healthy adult subjects. The study was conducted as an open-label, single dose escalation with 10 Filipino volunteers (5 men and 5 women). The subjects received a single dose of crocetin at three doses (7.5, 15 and 22.5 mg) in one week interval. Blood samples were collected from the brachial vein before and at 1, 2, 4, 6, 8, 10 and 24 h after administration. Plasma concentrations of crocetin were determined by high-performance liquid chromatography (HPLC). Crocetin was rapidly absorbed and detected within an hour of administration with a mean time to reach maximum concentration (T(max)) of crocetin ranging from 4.0 to 4.8 h. The mean values of C(max) and AUC(0-24h) ranged from 100.9 to 279.7 ng/ml and 556.5 to 1720.8 ng. h/ml respectively. C(max) and AUC values increased with dose proportional manner. Crocetin was eliminated from human plasma with a mean elimination half life (T(½) of 6.1 to 7.5 h. In summary, there were no serious adverse events up to 22.5 mg dose of crocetin while crocetin was found to be absorbed more quickly than the other carotenoids such as β-carotene, lutein and lycopene. Copyright © 2010 Elsevier GmbH. All rights reserved.

  18. The pharmacokinetics of a single oral or rectal dose of concurrently administered isoniazid, rifampin, pyrazinamide, and ethambutol in Asian elephants (Elephas maximus).

    Science.gov (United States)

    P Brock, A; Isaza, R; Egelund, E F; Hunter, R P; Peloquin, C A

    2014-10-01

    Tuberculosis, caused by Mycobacterium tuberculosis, is a disease of concern in captive Asian elephants (Elephas maximus). Treatment for tuberculosis in elephants utilizes multidrug protocols combining isoniazid, rifampin, pyrazinamide, and/or ethambutol. In this study, a single, coformulated dose of isoniazid 5 mg/kg, rifampin 10 mg/kg, pyrazinamide 30 mg/kg, and ethambutol 30 mg/kg was administered orally to six Asian elephants, and rectally to five elephants using a cross-over design. Blood samples were collected serially over 24 h. Pyrazinamide and ethambutol concentrations were determined using validated gas chromatography assays. Isoniazid and rifampin concentrations were determined using validated high-performance liquid chromatography assays. Rectal isoniazid produced an earlier Tmax compared with oral administration. Oral isoniazid resulted in a comparatively lower Cmax , but higher AUC values compared with rectal isoniazid. Oral rifampin and oral ethambutol were well absorbed while rectal rifampin was not. Oral pyrazinamide produced comparatively higher Cmax and AUC values compared with rectal pyrazinamide. Results of this study indicate that currently recommended therapeutic monitoring sample collection times for rectal isoniazid and oral rifampin do not provide an accurate assessment of exposure for these drugs. This study demonstrates notable individual variability, indicating that dosing of these medications requires individual monitoring and provides additional information to guide the clinician when treating elephants. © 2014 John Wiley & Sons Ltd.

  19. Associations of depression and seasonality with morning-evening preference: Comparison of contributions of its morning and evening components.

    Science.gov (United States)

    Putilov, Arcady A

    2018-04-01

    Despite predominance of positive findings on associations of morning-evening preference with seasonality and depression, it remains to be clarified whether morning and evening components of this preference equally contribute to these associations and whether these associations persist after accounting for confounding variables. Data on retrospectively reported seasonal changes in well-being, mood, and behaviors were collected from 2398 residents of West Siberia, South and North Yakutia, Chukotka, Alaska, and Turkmenistan. Other self-reports included mental and physical health, sleep duration, and adaptabilities of the sleep-wake cycle. Depression was found to be linked to morning rather than evening component of morning-evening preference, i.e., morning lateness. Morning lateness was also linked to retrospectively reported degree of seasonal changes rather than to severity of problems associated with such changes. Variation in morning-evening preference explained not more than 2% and 4% of the total variation in depression and seasonality, respectively. The associations became even weaker but remained significant after accounting for other differences between respondents, such as their gender, age, physical health, and adaptability of their sleep-wake cycle. These results have practical relevance for understanding of the roles playing by morning earliness and insensitivity to seasonal changes in the environment to protection against different mood disorders. Copyright © 2017 Elsevier B.V. All rights reserved.

  20. The light at the end of the tunnel: a single-operator learning curve analysis for per oral endoscopic myotomy.

    Science.gov (United States)

    Patel, Kumkum Sarkar; Calixte, Rose; Modayil, Rani J; Friedel, David; Brathwaite, Collin E; Stavropoulos, Stavros N

    2015-05-01

    Per oral endoscopic myotomy (POEM) represents a natural orifice transluminal endoscopic surgery approach to Heller myotomy. Our center was the first to offer POEM outside of Japan, allowing us to accumulate what is likely the highest single-operator POEM volume in the United States. To define the POEM learning curve of a gastroenterologist by using a larger data set and more detailed statistical analysis than used in 2 other reports of POEM performed by surgeons. Prospective cohort study. Tertiary-care academic medical center. We analyzed the first 93 consecutive POEMs on patients with achalasia aged >18 years without contraindications to POEM performed by a single operator from October 2009 to November 2013. (1) Efficiency estimation via cumulative sum (CUSUM) analysis, (2) mastery estimation via penalized basis-spline regression and CUSUM analysis, (3) correlation of operator experience with clinical outcomes (Eckardt score improvement, lower esophageal sphincter pressure reduction) and technical errors (accidental mucosotomy rate), and (4) unadjusted and adjusted regression analysis to assess how patient characteristics affected procedure time by using a generalized linear model. Clinical outcomes, procedure time, technical errors. Efficiency was attained after 40 POEMs and mastery after 60 POEMs. When we used the adjusted regression analysis, only case number (operator experience) significantly affected procedure time (P myotomy, or type of knife used (all P > .05). Our analysis may underestimate the number of POEMs required to achieve mastery for operators with limited or no endoscopic submucosal dissection experience. These results offer thresholds for efficiency and mastery of a single gastroenterologist operator that may guide the efforts of novice POEM operators. Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

  1. Single-dose pharmacokinetics and tolerability of oral delta-9- tetrahydrocannabinol in patients with amyotrophic lateral sclerosis.

    Science.gov (United States)

    Joerger, Markus; Wilkins, Justin; Fagagnini, Stefania; Baldinger, Reto; Brenneisen, Rudolf; Schneider, Ursula; Goldman, Bea; Weber, Markus

    2012-06-01

    Cannabinoids exert neuroprotective and symptomatic effects in amyotrophic lateral sclerosis (ALS). We assessed the pharmacokinetics (PK) and tolerability of delta-9-tetrahydrocannabinol (THC) in ALS patients. Nine patients received THC single oral doses of 5mg and 10mg, separated by a wash-out period of two weeks. Blood samples for the determination of THC, 11-nor-9-carboxy-THC (THC-COOH) and hydroxy-THC (THC-OH) were taken up to 8 hours after intake. Adverse events were assessed by visual analogue scales (VAS). Plasma concentrations of the active metabolite THC-OH were submitted to sequential pharmacokinetic-pharmacodynamic population modeling on individual heart rate as a proxy for THC's cardiovasculatory effects. Drowsiness, euphoria, orthostasis, sleepiness, vertigo and weakness were significantly more frequent in patients receiving 10mg compared to 5 mg THC. A marked interindividual variability was found for the absorption of oral THC (84%) and elimination of THC-COOH (45%). PK data did not support any clinically relevant deviation from linear PK in the investigated range of concentrations. Plasma concentrations of THC-OH were positively correlated with the individual heart rate. An E(max-model) was successfully fitted to individual heart rate, with a THC-OH plasma concentration of 3.2 x 10(-4) μmol/L for EC(50) and an E(max) of 93 bpm for heart rate. The higher 10mg dose of THC was dose-limiting in patients with ALS. High interindividual PK variability requires individuell titration of THC for potential therapeutic use in patients with ALS.

  2. Placental transfer and pharmacokinetics of a single oral dose of [14C] p-nitrophenol in rats

    International Nuclear Information System (INIS)

    Abu-Qare, A.W.; Brownie, C.F.; Abou-Donia, M.B.

    2000-01-01

    The pharmacokinetics and placental transfer of a single oral dose of 100 mg/kg (10 μCi/kg, 16% of acute oral LD 50 ) of uniformly phenyl-labeled [ 14 C]p-nitrophenol were investigated in pregnant Sprague-Dawley rats at 14-18 days of gestation. Three animals were killed on gestation day 18, at 0.5, 1, 2, 4, 12, 24, and 48 h after dosing. Radioactivity was rapidly absorbed and distributed throughout the maternal and fetal tissues. The gastrointestinal tract contents retained 20% and 2% of the dose at 0.5 h and 4 h after dosing. The peak maternal plasma concentration of radioactivity (μg p-nitrophenol equivalent/ml) was 7.17 compared with 0.37 for fetal plasma at 0.5 h. Maximum concentration of radioactivity (μg p-nitrophenol equivalent/g fresh tissue) was detected in most tissues 0.5 h after dosing and was in descending order: kidney 23.27, liver 12.37, placenta 3.56, fetus 2.17, and brain 1.99. Radioactivity was eliminated from plasma and all tissues beiexponentially. The half-lives of elimination of 14 C were 34.65 h and 69.30 h for maternal and fetal plasma, respectively. p-Nitrophenol, detected by HPLC, was the major compound identified in plasma and tissues. While p-nitrophenol disappeared biphasically from maternal plasma and kidney, it was eliminated monophasically from brain, placenta, and liver. p-Nitrocatechol and p-aminophenol were detected in the liver with peak concentrations at 0.5 h of 1.13 and 1.00 μg/g fresh tissue, respectively. While the change in the concentration of p-nitrocatechol with time was monophasic, that of p-aminophenol showed a biphasic pattern with elimination half-lives of 1.93 h and 4.95 h, respectively. Radioactivity was rapidly excreted in the urine mostly as polar metabolites, while only 3% of the dose was recovered in the feces. Radioactive materials excreted in the urine comprised: glucuronides 4%, sulfates 8%, hot-acid hydrolysates 11%, nonconjugated compounds 16%, and water-soluble metabolites 61%. This study demonstrated

  3. 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.

  4. Effects of acute morning and evening exercise on subjective and objective sleep quality in older individuals with insomnia.

    Science.gov (United States)

    Morita, Yuko; Sasai-Sakuma, Taeko; Inoue, Yuichi

    2017-06-01

    The aims of this study were to compare the effects of acute morning or evening exercise on nocturnal sleep in individuals with two subjective insomnia symptoms: difficulty in initiating sleep (DIS), and early morning awakening (EMA), separately for the first vs the second halves of the night. Older individuals (55-65 years old) with DIS (N = 15) or EMA (N = 15) and age- and sex-matched controls (N = 13) participated in this non-randomized crossover study. Participants were assigned to two exercise conditions (morning exercise and evening exercise) in counterbalanced order following the baseline condition with a two-week interval between conditions. A single session of aerobic step exercise was performed during each exercise condition. Nocturnal polysomnography was carried out to evaluate objective sleep quality. Patient global impression of change scale scores for nocturnal sleep were obtained to subjectively evaluate the different groups. Acute physical exercise did not improve subjective sleep quality. Morning exercise decreased the number of stage shifts over the whole night. The arousal index and the number of stage shifts were decreased especially during the second half of the night in all groups. Furthermore, morning exercise decreased the number of wake stages during the second half of the night in the DIS group, but not in the EMA group. Acute morning exercise can improve nocturnal sleep quality in individuals with difficulty initiating sleep, especially during the later part of the night. Copyright © 2017 Elsevier B.V. All rights reserved.

  5. Pharmacokinetics of Tedizolid Following Oral Administration: Single and Multiple Dose, Effect of Food, and Comparison of Two Solid Forms of the Prodrug

    OpenAIRE

    Flanagan, Shawn D; Bien, Paul A; Muñoz, Kelly A; Minassian, Sonia L; Prokocimer, Philippe G

    2013-01-01

    Objectives The single- and multiple-dose pharmacokinetics (PK) of tedizolid were examined after oral administration of tedizolid phosphate disodium (TPD), including the effect of food on PK. The relative bioavailability of TPD to the free acid tedizolid phosphate was determined to bridge the results of these and other studies to the solid form of the prodrug selected for further development. Design Randomized placebo-controlled, double-blind single- and multiple-ascending dose studies and ran...

  6. Efficacy and safety of a single oral 150 mg dose of fluconazole for the treatment of vulvovaginal candidiasis in Japan.

    Science.gov (United States)

    Mikamo, Hiroshige; Matsumizu, Miyako; Nakazuru, Yoshiomi; Okayama, Akifumi; Nagashima, Masahito

    2015-07-01

    Vulvovaginal candidiasis is the second most common cause of vaginal infections following bacterial vaginosis. For the treatment of vulvovaginal candidiasis, antifungal agents are used either as topical (vaginal tablets and cream) or oral formulations. A single oral 150 mg dose of fluconazole has been recommended as the standard therapy for uncomplicated, acute vulvovaginal candidiasis in global guidelines; however, in Japan oral fluconazole therapy has not been approved. We conducted a phase 3 study to evaluate the efficacy and safety of a single oral 150 mg dose of fluconazole in Japanese subjects with vulvovaginal candidiasis for regulatory submission. A total of 157 subjects received a single oral 150 mg dose of fluconazole. Candida species (104 strains) were identified by fungal culture from 102 subjects at baseline, including Candida albicans (100 strains). The efficacy rate for the therapeutic outcome (assessed based on a comprehensive evaluation of the clinical and mycological efficacy in each subject) was 74.7% (74/99) on Day 28 in the modified Intent-To-Treat (m-ITT) population. Concerning the clinical and mycological efficacy on Day 28 in the m-ITT population, the cure, cure or improvement, and eradication rates were 81.6%, 95.9%, and 85.9%, respectively. The most common treatment-related adverse events were diarrhea and nausea (1.9% for each). No clinically significant safety issues were reported. A single oral 150 mg dose of fluconazole demonstrated excellent therapeutic efficacy and was well tolerated in Japanese subjects with vulvovaginal candidiasis. NCT01806623. Copyright © 2015 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  7. The effect of a single oral megadose of vitamin D provided as either ergocalciferol (D2) or cholecalciferol (D3) in alcoholic liver cirrhosis

    DEFF Research Database (Denmark)

    Knudsen, Mikkel Malham; Jørgensen, S. P.; Lauridsen, A. L.

    2012-01-01

    Objective: The goal of this study was to examine the effects of a single oral dose of 300 000 international units of either ergocalciferol (D2) or cholecalciferol (D3) on the plasma levels of 25-hydroxyvitamin D in patients with alcoholic liver cirrhosis. Methods: Inclusion criteria for this stud...

  8. Changing Morning Report: An Educational Intervention to Address Curricular Needs

    Directory of Open Access Journals (Sweden)

    Vijay John Daniels

    2014-01-01

    Full Text Available Morning report is a case-based teaching session common to many residency programs with varying purposes and focuses. At our institution, physicians and residents felt our Internal Medicine morning report had lost its educational focus. The purpose of this project was to improve morning report using a well-known curriculum development framework for medical education. We conducted a focus group of residents to develop and implement changes to morning report. Themes from our focus group led us to split morning report with the first 30 minutes for postgraduate year 3 (PGY-3 residents to give handover, to receive feedback on diagnosis and management, and to either discuss an interesting case or receive teaching aimed at their final certification examination. The second 30 minutes involved PGY-3 residents leading PGY-1 residents in case-based discussions with an attending physician providing feedback on the content and process of teaching. We measured success based on a follow-up survey and comments from resident evaluations before and after the change. Overall, the changes were well received by both faculty and residents; however comments revealed that the success of morning report is preceptor dependent. In summary, we have successfully implemented a split morning report model to enhance resident education with positive feedback.

  9. Effect of treatment with single total-dose intravenous iron versus daily oral iron(III-hydroxide polymaltose on moderate puerperal iron-deficiency anemia

    Directory of Open Access Journals (Sweden)

    Iyoke CA

    2017-05-01

    Full Text Available Chukwuemeka Anthony Iyoke,1 Fausta Chioma Emegoakor,1 Euzebus Chinonye Ezugwu,1 Lucky Osaheni Lawani,2 Leonard Ogbonna Ajah,1 Jude Anazoeze Madu,3 Hyginus Uzo Ezegwui,1 Frank Okechukwu Ezugwu4 1Department of Obstetrics and Gynaecology, University of Nigeria, Enugu Campus, 2Department of Obstetrics and Gynaecology, Federal Teaching Hospital, Abakaliki, 3Department of Haematology, University of Nigeria, Nsukka, 4Department of Obstetrics and Gynaecology, College of Medicine, Enugu State University, Enugu, Nigeria Background: Iron-deficiency anemia is the most common nutritional cause of anemia in pregnancy and is often responsible for puerperal anemia. Puerperal anemia can impair postpartum maternal and neonatal well-being. Objective: To determine the effect of treatment of moderate puerperal iron-deficiency anemia using a single intravenous total-dose iron dextran versus daily single dose oral iron(III-hydroxide polymaltose. Methodology: A randomized controlled study in which postpartum women with moderate iron-deficiency anemia were randomized into treatment with either a single total-dose intravenous iron dextran or with daily single doses of oral iron(III-hydroxide polymaltose tablets for 6 weeks. Effects on hemoglobin concentration using either method were compared at 6 weeks postpartum. Analysis was per protocol using SPSS version 17 for windows. P-values ≤0.05 were considered significant. Results: Two hundred eighty-four women were recruited for the study: 142 women received single total dose intravenous infusion of iron dextran while 142 received daily oral iron(III-hydroxide polymaltose tablets. Approximately 84.0% (237/282 completed the study and were analyzed including 81% (115/142 of those randomized to injectable iron therapy compared to 85.9% (122/142 of those randomized to oral treatment. The proportions of women who had attained hemoglobin concentration of at least 10 g/dL by the 6 weeks postpartum visit did not differ

  10. Morning cortisol levels and glucose metabolism parameters in moderate and severe obstructive sleep apnea patients.

    Science.gov (United States)

    Bozic, Josko; Galic, Tea; Supe-Domic, Daniela; Ivkovic, Natalija; Ticinovic Kurir, Tina; Valic, Zoran; Lesko, Josip; Dogas, Zoran

    2016-09-01

    Obstructive sleep apnea (OSA) has been associated with dysregulation of the hypothalamic-pituitary-adrenal axis and alterations in glucose metabolism with increased risk for type 2 diabetes. The aim of the current study was to compare morning plasma cortisol levels and glucose metabolism parameters between moderate (apnea-hypopnea index (AHI): 15-30 events/h) and severe OSA patients (AHI >30 events/h), with respective controls. A total of 56 male OSA patients, 24 moderate (AHI = 21.1 ± 5.3) and 32 severe (AHI = 49.7 ± 18.1), underwent a full-night polysomnography, oral glucose tolerance test (OGTT), and measurement of morning plasma cortisol levels. These groups were compared to 20 matched subjects in a control group. Morning plasma cortisol levels were statistically lower in severe OSA group than in moderate OSA and control groups (303.7 ± 93.5 vs. 423.9 ± 145.1 vs. 417.5 ± 99.8 pmol/L, P morning plasma cortisol levels and AHI (r = -0.444, P = 0.002), as well as oxygen desaturation index (r = -0.381, P = 0.011). Fasting plasma glucose (5.0 ± 0.5 vs. 5.4 ± 0.7 vs. 4.9 ± 0.6 mmol/L, P = 0.009) was higher in the severe OSA group compared to moderate OSA and controls. Homeostasis model assessment insulin resistance (HOMA-IR) was higher in the severe OSA group compared to moderate OSA and controls (4.6 ± 3.7 vs. 2.7 ± 2.0 and 2.2 ± 1.8, respectively, P = 0.006). In conclusion, our study showed that morning plasma cortisol levels measured at 8 a.m. were significantly lower in severe OSA patients than those in moderate OSA group and controls. Morning plasma cortisol levels showed a negative correlation with AHI and oxygen desaturation index. Additionally, this study confirmed the evidence of glucose metabolism impairment in moderate and severe OSA patients, with more pronounced effect in the severe OSA patients group.

  11. One-piece zirconia oral implants: one-year results from a prospective cohort study. 1. Single tooth replacement.

    Science.gov (United States)

    Kohal, Ralf-Joachim; Knauf, Marko; Larsson, Birgitta; Sahlin, Herman; Butz, Frank

    2012-06-01

    To investigate the clinical and radiographic outcome of a one-piece zirconia oral implant for single tooth replacement after 1 year. A total of 65 patients received a one-stage implant surgery with immediate temporization. Standardized radiographs were taken at implant insertion and after 1 year to monitor peri-implant bone loss. A univariate analysis of the influence of different baseline parameters on marginal bone loss from implant insertion to 12 months was performed. Soft tissue parameters were evaluated at prosthesis insertion and at the 1-year follow-up. After 1 year, three implants were lost, giving a cumulative survival rate of 95.4%. The marginal bone loss after 1 year was 1.31 mm. Thirty-four per cent of the implants lost at least 2 mm bone, and 14% more than 3 mm. The univariate analysis could not depict any parameter influencing marginal bone loss. Probing depth, Clinical Attachment Level, Bleeding and Plaque Index decreased over 1 year. The cumulative survival rate of the presented ceramic implant was comparable to the reported survival rate of titanium implants when immediately restored. However, the frequency of increased radiographic bone loss (>2 mm) after 1 year was considerably higher as compared to conventional two-piece titanium implants. The presented zirconia implant can therefore not be recommended for clinical usage. © 2012 John Wiley & Sons A/S.

  12. Single dose of diclofenac or meloxicam for control of pain, facial swelling, and trismus in oral surgery.

    Science.gov (United States)

    Orozco-Solís, Mariana; García-Ávalos, Yazmín; Pichardo-Ramírez, Celeste; Tobías-Azúa, Francisco; Zapata-Morales, Juan-Ramón; Aragon-Martínez, Othoniel-Hugo; Isiordia-Espinoza, Mario-Alberto

    2016-01-01

    Postoperative pain associated with removal of mandibular third molars has been documented from moderate to severe during the first 24 hours after surgery, with pain peaking between 6 and 8 hours when a conventional local anesthetic is used. Dental pain is largely inflammatory, and evidence-based medicine has shown that nonsteroidal anti-inflammatory drugs are the best analgesics for dental pain. The aim of this study was to compare the analgesic, anti-inflammatory and anti-trismus effect of a single dose of diclofenac and meloxicam after mandibular third molar extraction. A total of 36 patients were randomized into two treatment groups, each with 18 patients, using a series of random numbers: Group A, was administered 100 mg of diclofenac; and Group B, 15 mg of meloxicam. Drugs were administered orally 1 hour prior to surgery. We evaluated pain intensity, analgesic consumption, swelling, as well as trismus. The results of this study showed that patients receiving 15 mg of meloxicam had less postoperative pain (P=0.04) and better aperture than those receiving 100 mg of diclofenac (P=0.03). The meloxicam group presented less swelling than diclofenac group; however, significant statistical differences were not observed. Data of this double-blind, randomized, parallel-group clinical trial demonstrated that patients receiving 15 mg of preoperative meloxicam had a better postoperative analgesia and anti-trismus effect compared with who were given 100 mg of diclofenac after third molar extractions.

  13. Single-dose oral fluconazole versus topical clotrimazole in patients with pityriasis versicolor: A double-blind randomized controlled trial.

    Science.gov (United States)

    Dehghan, Mohammad; Akbari, Negin; Alborzi, Nazila; Sadani, Somayeh; Keshtkar, Abas A

    2010-08-01

    This study was designed to compare the therapeutic effects of topical clotrimazole and systemic fluconazole in pityriasis versicolor. A double-blind randomized controlled trial was carried out in the dermatological clinic of Gorgan, northern Iran, between April 2006 and May 2007. All consecutive patients with pityriasis versicolor were included and randomly divided into two groups. In the first group (G1), patients underwent treatment with a single dose of fluconazole capsule (400 mg) and placebo cream. In the second group (G2), patients underwent treatment with clotrimazole cream (twice daily) and placebo capsule. The course of treatment was 2 weeks. All subjects were re-evaluated 2, 4 and 12 weeks after the end of the therapeutic course. After 2 weeks, the rate of complete resolution of disease was significantly higher in G2 than G1 (49.1% vs 30%). After 4 weeks, 41 patients (81.2%) of G1 and 52 patients (94.9%) of G2 showed complete resolution. After 12 weeks, 46 patients (92%) in G1 and 45 patients (81.8%) in G2 showed complete resolution. Recurrence rate in G1 and G2 were 6% and 18.2%, respectively. No complications were seen in either group. In this study, clinical response at week 4 was greater in the clotrimazole group than the fluconazole group. Recurrence at week 12 after treatment was less with oral fluconazole than clotrimazole cream. So, for better evaluation, more studies need to be done.

  14. A high performance liquid chromatographic assay of mefloquine in saliva after a single oral dose in healthy adult Africans.

    Science.gov (United States)

    Gbotosho, Grace O; Happi, Christian T; Lawal, Omowunmi; Sijuade, Abayomi; Sowunmi, Akin; Oduola, Ayoade

    2012-02-27

    Mefloquine-artesunate is a formulation of artemisinin based combination therapy (ACT) recommended by the World Health Organization and historically the first ACT used clinically. The use of ACT demands constant monitoring of therapeutic efficacies and drug levels, in order to ensure that optimum drug exposure is achieved and detect reduced susceptibility to these drugs. Quantification of anti-malarial drugs in biological fluids other than blood would provide a more readily applicable method of therapeutic drug monitoring in developing endemic countries. Efforts in this study were devoted to the development of a simple, field applicable, non-invasive method for assay of mefloquine in saliva. A high performance liquid chromatographic method with UV detection at 220 nm for assaying mefloquine in saliva was developed and validated by comparing mefloquine concentrations in saliva and plasma samples from four healthy volunteers who received single oral dose of mefloquine. Verapamil was used as internal standard. Chromatographic separation was achieved using a Hypersil ODS column. Extraction recoveries of mefloquine in plasma or saliva were 76-86% or 83-93% respectively. Limit of quantification of mefloquine was 20 ng/ml. Agreement between salivary and plasma mefloquine concentrations was satisfactory (r = 0.88, p mefloquine in saliva paralleled that in plasma, making salivary quantification of mefloquine potentially useful in therapeutic drug monitoring. © 2012 Gbotosho et al; licensee BioMed Central Ltd.

  15. Placental transfer, disposition, and metabolism of a single oral dose of [14CH3S] methamidophos in Sprague Dawley rat

    International Nuclear Information System (INIS)

    Salama, A.K.; Bakry, N.M.; Aly, H.A.; Abou-Donia, M.B.

    1990-01-01

    A single oral dose of 8 mg/kg (8 μci/kg) of [ 14 CH 3 S]methamidophos was administered on day 18 of gestation to pregnant Sprague Dawley rats. Eight groups of three rats were killed after 10 min. and 0.5, 1, 3, 6, 12, 24, 48 hr. At termination, 27.10% of the radioactivity was excreted in the urine, but only 4.19% of the dose was recovered in the feces. Also, 24.59% was recovered as 14 CO 2 , while only 0.11% was detected in expired air as volatile materials. Radiolabeled material was rapidly absorbed and distributed in the tissues with levels in most tissues peaking at one hour. A total of 1.73% of the dose was recovered in the fetus. Methamidophos and its metabolites were analyzed by gas-liquid chromatography/mass spectrometry, thin-layer chromatography and liquid scintillation counting. Methamidophos disappeared biexponentially from tissues and the fetus. The terminal half-lives of methamidophos were 94 and 13.5 hr for plasma and fetus, respectively. The major metabolites in the tissues were monomethyl phosphoramidate and monomethyl phosphate. In addition to these metabolites, phosphoric acid was found in the liver, kidneys, lung, uterus, fetus and urine

  16. Effect of food on the pharmacokinetics of rosuvastatin after administration of a single oral dose in dogs.

    Science.gov (United States)

    Baek, I-H; Kwon, K-I; Kim, M-S

    2013-03-01

    Rosuvastatin is a highly effective inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase and is used for the treatment of patients with hyperlipidemia. We examined the effect of food on the pharmacokinetics of rosuvastatin by administering it while fasting and after intake of low-fat and high-fat meals. We administered a single 10-mg oral dose of rosuvastatin while fasting and after intake of a low-fat and high-fat meal in a parallel design. The plasma concentrations of rosuvastatin were measured using liquid chromatography tandem mass spectrometry (LC-MS/MS), and the pharmacokinetics of rosuvastatin was analyzed using both noncompartmental and compartmental models. The values of area under the curve at 24 h (AUC 24 h ) and peak plasma concentration (C max) in fed conditions were significantly lower than the corresponding values in the fasting conditions. In addition, consumption of a high-fat meal significantly delayed the time required to achieve the maximum concentration (T max) of rosuvastatin. Both the models sufficiently explained the effect of food on the pharmacokinetics of rosuvastatin and showed that the volume of distribution (V c) was increased and absorption rate constant (K a) was decreased in fed dogs. These findings suggest that food intake affects both the rate and extent of absorption of rosuvastatin, and that rosuvastatin should be administered on an empty stomach to avoid food effect. © Georg Thieme Verlag KG Stuttgart · New York.

  17. A high performance liquid chromatographic assay of Mefloquine in saliva after a single oral dose in healthy adult Africans

    Directory of Open Access Journals (Sweden)

    Gbotosho Grace O

    2012-02-01

    Full Text Available Abstract Background Mefloquine-artesunate is a formulation of artemisinin based combination therapy (ACT recommended by the World Health Organization and historically the first ACT used clinically. The use of ACT demands constant monitoring of therapeutic efficacies and drug levels, in order to ensure that optimum drug exposure is achieved and detect reduced susceptibility to these drugs. Quantification of anti-malarial drugs in biological fluids other than blood would provide a more readily applicable method of therapeutic drug monitoring in developing endemic countries. Efforts in this study were devoted to the development of a simple, field applicable, non-invasive method for assay of mefloquine in saliva. Methods A high performance liquid chromatographic method with UV detection at 220 nm for assaying mefloquine in saliva was developed and validated by comparing mefloquine concentrations in saliva and plasma samples from four healthy volunteers who received single oral dose of mefloquine. Verapamil was used as internal standard. Chromatographic separation was achieved using a Hypersil ODS column. Results Extraction recoveries of mefloquine in plasma or saliva were 76-86% or 83-93% respectively. Limit of quantification of mefloquine was 20 ng/ml. Agreement between salivary and plasma mefloquine concentrations was satisfactory (r = 0.88, p Conclusion Disposition of mefloquine in saliva paralleled that in plasma, making salivary quantification of mefloquine potentially useful in therapeutic drug monitoring.

  18. Pharmacokinetics of toltrazuril and its metabolites, toltrazuril sulfoxide and toltrazuril sulfone, after a single oral administration to pigs.

    Science.gov (United States)

    Lim, Jong-Hwan; Kim, Myoung-Seok; Hwang, Youn-Hwan; Song, In-Bae; Park, Byung-Kwon; Yun, Hyo-In

    2010-08-01

    Toltrazuril (TZR) is a triazine-based antiprotozoal agent. Following a single oral administration of TZR at 10 and 20 mg/kg to male pigs, the mean TZR concentration in plasma peaked at 4.24 and 8.18 microg/ml at 15.0 and 12.0 hr post-dose, respectively. TZR absorbed was rapidly converted to the short-lived intermediary metabolite toltrazuril sulfoxide (TZR-SO), and then metabolized to the reactive toltrazuril sulfone (TZR-SO2). TZR-SO2 was actually more slowly eliminated, with average half-lives of 231 and 245 hr, compared with TZR (48.7 and 68.9 hr) or TZR-SO (51.9 and 53.2 hr) in the 10 and 20 mg/kg groups, respectively. This study demonstrates that TZR metabolizes to TZR-SO2 having a long-terminal half-life, enabling the persistent clinical efficacy in the treatment of I. suis infection. In contrast, special consideration should be given to the residual of TZR-SO2.

  19. Factors associated with acute oral mucosal reaction induced by radiotherapy in head and neck squamous cell carcinoma: A retrospective single-center experience.

    Science.gov (United States)

    Tao, Zhenchao; Gao, Jin; Qian, Liting; Huang, Yifan; Zhou, Yan; Yang, Liping; He, Jian; Yang, Jing; Wang, Ru; Zhang, Yangyang

    2017-12-01

    To investigate risk factors for acute oral mucosal reaction during head and neck squamous cell carcinoma radiotherapy.A retrospective study of patients with head and neck squamous cell carcinoma who underwent radiotherapy from November 2013 to May 2016 in Anhui Provincial Cancer Hospital was conducted. Data on the occurrence and severity of acute oral mucositis were extracted from clinical records. Based on the Radiation Therapy Oncology Group (RTOG) grading of acute radiation mucosal injury, the patients were assigned into acute reaction (grades 2-4) and minimum reaction (grades 0-1) groups. Preradiotherapy characteristics and treatment factors were compared between the 2 groups. Multivariate logistic regression analysis was used to detect the independent factors associated with acute oral mucosal reactions.Eighty patients completed radiotherapy during the study period. Oral mucosal reactions were recorded as 25, 31, and 24 cases of grades 1, 2, and 3 injuries, respectively. Significant differences between acute reaction and minimum reaction groups were detected in cancer lymph node (N) staging, smoking and diabetes history, pretreatment platelet count and T-Helper/T-Suppressor lymphocyte (Th/Ts) ratio, concurrent chemotherapy, and total and single irradiation doses.Multivariate analysis showed that N stage, smoking history, single dose parapharyngeal irradiation, and pretreatment platelet count were independent risk factors for acute radiation induced oral mucosal reaction. Smoking history, higher grading of N stage, higher single dose irradiation, and lower preirradiation platelet count may increase the risk and severity of acute radiation oral mucosal reaction in radiotherapy of head and neck cancer patients. Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.

  20. Second Morning ACR Could Be the Alternative to First Morning ACR to Assess Albuminuria in Elderly Population.

    Science.gov (United States)

    Wang, Hua-Bin; Li, Rong; Liu, Rui; Cui, Xiao-Fan; Pan, Wen-Jie; Sun, Ao

    2016-03-01

    Albumin/creatinine ratio (ACR) from a first morning urine is recommended as a early indicator for diabetic nephropathy. However, it is not always feasible to collect the first morning urine for outpatients. We aimed to explore whether ACR from a second morning urine had a good consistency with that from a first morning urine to predict albuminuria in Chinese elderly citizens. One hundred and ninety-one elderly citizens (≧60 years old) from Junliangcheng community, Dongli district, Tianjin, China were included. A first and second morning urine was collected from each participants, successfully and detected the urinary albumin and creatinine of each urine sample. Albumin to creatinine ratio from a first morning urine (ACR1) was compared with that from a second morning urine (ACR2), and the ability of ACR1 and ACR2 to predict albuminuria was assessed. ACR1 and ACR2 were highly correlated (r = 0.901), especially in male and hypertension group (r = 0.938 and 0.904). The slope and intercept were 0.93 and 0.11 after log-transformed. And there was no statistical difference between values of ACR1 and ACR2 (P = 0.271). Overall, 26.2% participants were detected with albuminuria when judged by ACR1 and 28.3% by ACR2. A good concordance of ACR category (normal or albuminuria) was found between ACR1 and ACR2 (Kappa value = 0.815 in overall; in male and hypertension group were 0.900 and 0.850). A second morning urine ACR could be the alternative to a first morning urine ACR for albuminuria detection in elderly population. © 2015 Wiley Periodicals, Inc.

  1. Comparison of morning and afternoon exercise training for asthmatic children

    Directory of Open Access Journals (Sweden)

    C.S. Silva

    2006-01-01

    Full Text Available Fitness improvement was used to compare morning with afternoon exercise periods for asthmatic children. Children with persistent moderate asthma (according to GINA criteria, 8 to 11 years old, were divided into 3 groups: morning training group (N = 23, afternoon training group (N = 23, and non-training group (N = 23. The program was based on twice a week 90-min sessions for 4 months. We measured the 9-min running distance, resting heart rate and abdominal muscle strength (sit-up number before and after the training. All children took budesonide, 400 µg/day, and an on demand inhaled ß-agonist. The distance covered in 9 min increased (mean ± SEM from 1344 ± 30 m by 248 ± 30 m for the morning group, from 1327 ± 30 m by 162 ± 20 m for the afternoon group, and from 1310 ± 20 m by 2 ± 20 m for the control group (P 0.05 for morning with afternoon comparison. The reduction of resting heart rate from 83 ± 1, 85 ± 2 and 86 ± 1 bpm was 5.1 ± 0.8 bpm in the morning group, 4.4 ± 0.8 bpm in the afternoon group, and -0.2 ± 0.7 bpm in the control group (P > 0.05 for morning with afternoon comparison and P 0.05 for morning with afternoon comparison and P < 0.05 versus control. No statistically significant differences were detected between the morning and afternoon groups in terms of physical training of asthmatic children.

  2. Single-Tooth Implant Versus Three-Unit Fixed Partial Denture: A Study of Oral Health-Related Quality of Life.

    Science.gov (United States)

    Park, Sun-Young; Oh, Sung-Hee; Kim, Jimin; Jung, Yea Ji; Park, Joo-Yeon; Lee, Eui-Kyung; Kim, Seong-Kyun; Kim, Younhee

    2016-01-01

    Many studies have investigated the impact of prosthetic treatment on oral health-related quality of life (OHRQoL). However, most of these have been performed among fully or partially edentulous patients. Studies involving patients with a single missing tooth are limited. The purpose of this study was to compare the OHRQoL between patients treated by single-tooth implants and three-unit fixed partial dentures (FPDs) for single missing tooth restoration. A cross-sectional survey was conducted in Korea with patients drawn by stratified purposive sampling based on age. OHRQoL was measured using the Korean version of the 14-item Oral Health Impact Profile (OHIP-14K) questionnaire. Pre- and posttreatment OHIP-14K scores were compared by paired t test. Single-tooth implants and three-unit FPDs were compared by two-sample t test. In addition, multiple regression analysis was used to evaluate the impact of treatment mode on OHIP-14K total score after adjusting the effect of demographics and clinical factors. Thirty-five patients with single-tooth implants and 36 patients with three-unit FPDs were included. All participants had a significant improvement in OHRQoL compared with before the treatment (P single-tooth implants and three-unit FPDs for single missing tooth replacement resulted in significant and similar improvement of OHRQoL.

  3. COPD symptoms in the morning: impact, evaluation and management

    Science.gov (United States)

    2013-01-01

    Chronic obstructive pulmonary disease (COPD) symptoms in the morning, including dyspnea and sputum production, affect patients’ quality of life and limit their ability to carry out even simple morning activities. It is now emerging that these symptoms are associated with increased risk of exacerbations and work absenteeism, suggesting that they have a more profound impact on patients than previously thought. The development of validated patient-reported outcome (PRO) questionnaires to capture patients’ experience of COPD symptoms in the morning is, therefore, vital for establishing effective and comprehensive management strategies. Although it is well established that long-acting bronchodilators are effective in improving COPD symptoms, the limited available data on their impact on morning symptoms and activities have been obtained with non-validated PRO questionnaires. In this review, we discuss the impact of COPD symptoms in the morning and available tools used to evaluate them, and highlight specific gaps that need to be addressed to develop standardized instruments able to meet regulatory requirement. We also present available evidence on the effect of pharmacological therapies on morning symptoms. PMID:24143997

  4. Macronutrient composition of a morning meal and the maintenance of attention throughout the morning.

    Science.gov (United States)

    Wilson, Tommy J; Gray, Michael J; Van Klinken, Jan-Willem; Kaczmarczyk, Melissa; Foxe, John J

    2017-07-17

    At present, the impact of macronutrient composition and nutrient intake on sustained attention in adults is unclear, although some prior work suggests that nutritive interventions that engender slow, steady glucose availability support sustained attention after consumption. A separate line of evidence suggests that nutrient consumption may alter electroencephalographic markers of neurophysiological activity, including neural oscillations in the alpha-band (8-14 Hz), which are known to be richly interconnected with the allocation of attention. It is here investigated whether morning ingestion of foodstuffs with differing macronutrient compositions might differentially impact the allocation of sustained attention throughout the day as indexed by both behavior and the deployment of attention-related alpha-band activity. Twenty-four adult participants were recruited into a three-day study with a cross-over design that employed a previously validated sustained attention task (the Spatial CTET). On each experimental day, subjects consumed one of three breakfasts with differing carbohydrate availabilities (oatmeal, cornflakes, and water) and completed blocks of the Spatial CTET throughout the morning while behavioral performance, subjective metrics of hunger/fullness, and electroencephalographic (EEG) measurements of alpha oscillatory activity were recorded. Although behavior and electrophysiological metrics changed over the course of the day, no differences in their trajectories were observed as a function of breakfast condition. However, subjective metrics of hunger/fullness revealed that caloric interventions (oatmeal and cornflakes) reduced hunger across the experimental day with respect to the non-caloric, volume-matched control (water). Yet, no differences in hunger/fullness were observed between the oatmeal and cornflakes interventions. Observation of a relationship between macronutrient intervention and sustained attention (if one exists) will require further

  5. Effect of active warm-up duration on morning short-term maximal performance during Ramadan.

    Science.gov (United States)

    Baklouti, Hana; Chtourou, Hamdi; Aloui, Asma; Chaouachi, Anis; Souissi, Nizar

    2015-01-01

    To examine the effect of active warm-up duration on short-term maximal performance assessed during Ramadan in the morning. Twelve healthy active men performed four Wingate tests for measurement of peak power and mean power before and during Ramadan at 09:00 a.m. The tests were performed on separate days, after either a 5-min or a 15-min warm-up. The warm-up consisted in pedaling at 50% of the power output obtained at the last stage of a submaximal multistage cycling test. Oral temperature was measured at rest and after warming-up. Furthermore, ratings of perceived exertion were obtained immediately after the Wingate test. Oral temperature was higher after the 15-min warm-up than the 5-min warm-up throughout the study. Moreover, peak power and mean power were higher after the 15-min warm-up than the 5-min warm-up before Ramadan. However, during Ramadan, there was no significant difference between the two warm-up durations. In addition, ratings of perceived exertion were higher after the 15-min warm-up than the 5-min warm-up only during Ramadan. There is no need to prolong the warm-up period before short-term maximal exercise performed during Ramadan in the morning.

  6. Predictive single nucleotide polymorphism markers for acute oral mucositis in patients with nasopharyngeal carcinoma treated with radiotherapy

    Science.gov (United States)

    Le, Ziyu; Niu, Xiaoshuang; Chen, Ying; Ou, Xiaomin; Zhao, Guoqi; Liu, Qi; Tu, Wenzhi; Hu, Chaosu; Kong, Lin; Liu, Yong

    2017-01-01

    The aim of this study was to investigate the association between the susceptibility of severe oral mucositis (OM) in Chinese nasopharyngeal carcinoma (NPC) patients treated with radiotherapy and single nucleotide polymorphisms (SNPs) across the whole genome. SNPs were screened in a total of 24 patients with NPC and an additional 6 were subjected to mRNA expression analysis. Patients were subdivided into CTC 0-2 (CTC toxicity grade 0, 1, and 2) and CTC 3+ (CTC toxicity grade 3 and above) groups according to their CTC (common toxicity criteria) scores. The GTEx dataset was used to performed eQTL analyses and in-vitro functional assays were performed for eQTL-associated genes. Our data identified 7 functional SNPs associated with the development of OM. We observed that rs11081899-A, located in the 5′-UTR of the ZNF24 gene, was significantly correlated with a higher risk of severe mucositis (OR = 14.631, 95% CI = 2.61-105.46, p = 1.2 × 10−4), and positively associated with ZNF24 mRNA expression (p = 4.1 × 10−6) from GTEx dataset. In addition, high ZNF24 mRNA expression was associated with severe OM in patients with NPC (p = 0.02). Further functional assays revealed that ZNF24 knockdown reduced p65 expression and suppressed TNF-α-induced NF-κB activation and pro-inflammatory cytokines release. These findings suggested that rs11081899-A may be a genetic susceptibility factor for radiation-induced OM in patients with NPC, although its value in clinical application needs to be further verified in a large cohort. Also, we suggested that downregulation of ZNF24 may attenuate the development of mucositis by suppressing NF-κB activation. PMID:28968968

  7. Mass balance, metabolic disposition, and pharmacokinetics of a single oral dose of regorafenib in healthy human subjects.

    Science.gov (United States)

    Gerisch, Michael; Hafner, Frank-Thorsten; Lang, Dieter; Radtke, Martin; Diefenbach, Konstanze; Cleton, Adriaan; Lettieri, John

    2018-01-01

    To evaluate the mass balance, metabolic disposition, and pharmacokinetics of a single dose of regorafenib in healthy volunteers. In addition, in vitro metabolism of regorafenib in human hepatocytes was investigated. Four healthy male subjects received one 120 mg oral dose of regorafenib containing approximately 100 µCi (3.7 MBq) [ 14 C]regorafenib. Plasma concentrations of parent drug were derived from HPLC-MS/MS analysis and total radioactivity from liquid scintillation counting (LSC). Radiocarbon analyses used HPLC with fraction collection followed by LSC for all urine samples, plasma, and fecal homogenate extracts. For the in vitro study, [ 14 C]regorafenib was incubated with human hepatocytes and analyzed using HPLC-LSC and HPLC-HRMS/MS. Regorafenib was the major component in plasma, while metabolite M-2 (pyridine N-oxide) was the most prominent metabolite. Metabolites M-5 (demethylated pyridine N-oxide) and M-7 (N-glucuronide) were identified as minor plasma components. The mean concentration of total radioactivity in plasma/whole blood appeared to plateau at 1-4 h and again at 6-24 h post-dose. In total, 90.5% of administered radioactivity was recovered in the excreta within a collection interval of 12 days, most of which (71.2%) was eliminated in feces, while excretion via urine accounted for 19.3%. Regorafenib (47.2%) was the most prominent component in feces and was not excreted into urine. Excreted metabolites resulted from oxidative metabolism and glucuronidation. Regorafenib was eliminated predominantly in feces as well as by hepatic biotransformation. The multiple biotransformation pathways of regorafenib decrease the risk of pharmacokinetic drug-drug interactions.

  8. Toxicokinetics and toxicological effects of single oral dose of fumonisin B1 containing Fusarium verticillioides culture material in weaned piglets.

    Science.gov (United States)

    Dilkin, P; Direito, G; Simas, M M S; Mallmann, C A; Corrêa, B

    2010-05-14

    Toxicokinetics and the toxicological effects of culture material containing fumonisin B(1) (FB(1)) were studied in male weaned piglets by clinical, pathological, biochemical and sphingolipid analyses. The animals received a single oral dose of 5 mg FB(1)/kg of body weight, obtained from Fusarium verticillioides culture material. FB(1) was detected by HPLC in plasma collected at 1-h intervals up to 6h and at 12-h intervals up to 96 h. FB(1) eliminated in feces and urine was quantified over a 96-h period and in liver samples collected 96 h post-intoxication. Blood samples were obtained at the beginning and end of the experiment to determine serum enzyme activity, total bilirubin, cholesterol, sphinganine (Sa), sphingosine (So) and the Sa/So ratio. FB(1) was detected in plasma between 30 min and 36 h after administration. The highest concentration of FB(1) was observed after 2 h, with a mean concentration of 282 microg/ml. Only 0.93% of the total FB(1) was detected in urine between 75 min and 41 h after administration, the highest mean concentration (561 microg/ml) was observed during the interval after 8 at 24 h. Approximately 76.5% of FB(1) was detected in feces eliminated between 8 and 84 h after administration, with the highest levels observed between 8 and 24 h. Considering the biochemical parameters, a significant increase only occurred in cholesterol, alkaline phosphatase and aspartate aminotransferase activities. In plasma and urine, the highest Sa and Sa/So ratios were obtained at 12 and 48 h, respectively. Copyright 2010 Elsevier Ireland Ltd. All rights reserved.

  9. Nocturnal urinary melatonin excretion and plasma cortisol levels in children and adolescents after a single oral dose of dexamethasone.

    Science.gov (United States)

    Lang, U; Theintz, G; Rivest, R W; Sizonenko, P C

    1986-08-01

    In the present study, the possible relationship between melatonin secretion as reflected by nocturnal melatonin excretion (2000 h-0800 h) and the pituitary-adrenocortical axis was investigated. Nocturnal urinary melatonin excretion and plasma cortisol levels were determined in 41 children with weight problems before and after a single oral dose of dexamethasone. A first group of 15 individuals with normal cortisol cycle (12.2 +/- 1.4 at 0800 h and 3.1 +/- 0.5 micrograms/100 ml at 1700 h), and levels below 1.0 microgram/100 ml after dexamethasone, showed a highly significant increase in melatonin excretion during the night following dexamethasone treatment (63.5 +/- 5.5 ng/12 h vs 33.6 +/- 3.0 for the control night, P less than 0.001). This increase was observed from prepuberty to young adulthood (pubertal stages PI-PV). In a second group of 16 subjects with mean cortisol levels similar at 0800 h and 1700 h (10.7 +/- 1.3 and 9.3 +/- 1.5 micrograms/100 ml respectively), but with a normal cortisol suppression after dexamethasone administration, nocturnal melatonin excretion increased from 21.2 +/- 2.1 to 33.4 +/- 3.0 ng/12 h (P less than 0.01). A significant increase was found in prepubertal children (PI) whereas no change was observed at the end of pubertal development (stages PIV-PV). A third group of 10 patients with both low amplitude cortisol cycles (16.2 +/- 2.5 and 10.8 +/- 2.4 micrograms/100 ml) and abnormal cortisol suppression after dexamethasone administration (9.1 +/- 2.4 micrograms/100 ml), showed no increase in melatonin excretion (24.2 +/- 2.7 and 24.9 +/- 3.7 ng/12 h).(ABSTRACT TRUNCATED AT 250 WORDS)

  10. Morning-only polyethylene glycol is noninferior but less preferred by hospitalized patients as compared with split-dose bowel preparation.

    Science.gov (United States)

    Kotwal, Vikram S; Attar, Bashar M; Carballo, Mauricio D; Lee, Salina S; Kaura, Tarun; Go, Benjamin; Zhang, Huiyuan; Trick, William E

    2014-01-01

    To compare the efficacy and tolerability of morning-only polyethylene glycol (PEG) with split-dose preparation in hospitalized patients scheduled for colonoscopy. Morning-only colonoscopy preparation may improve efficiency by allowing patient preparation and colonoscopy to be performed on the same day. There are limited data comparing morning-only with split-dose preparation, and more studies are needed before morning-only preparation can be routinely recommended. A single-center, prospective, endoscopist-blinded study was conducted, in which hospitalized patients scheduled to undergo diagnostic colonoscopy were randomly assigned to receive 4 L of PEG either on the morning of colonoscopy or as a split-dose (evening-morning). The primary endpoint was efficacy of bowel preparation measured by the Ottawa scale. Secondary endpoints were patient compliance and tolerance. A total of 120 hospitalized patients scheduled for diagnostic colonoscopy were randomized. The mean total Ottawa score was slightly superior for the morning-only arm, and the upper bound of 95% confidence interval (CI) for difference between arms was less than our prespecified noninferiority margin of 1.5 (difference=-0.23; 95% CI, -1.72 to 1.25). The percentage of patients with good bowel preparation was similar for all colonic segments. There was a trend toward more side effects among patients in the morning-only compared with the split-dose arm (71% vs. 54%; P=0.08). Compared with morning-only preparation, more patients in the split-dose arm were willing to undergo similar preparation for future colonoscopies (71% vs. 89%; P=0.02). Morning-only PEG is not inferior to split-dose preparation regarding bowel cleansing efficacy for colonoscopy in hospitalized patients. However, split-dose preparation was preferred by patients because of less side effects.

  11. A Randomized controlled trial on safety and efficacy of single intramuscular versus staggered oral dose of 600 000IU Vitamin D in treatment of nutritional rickets.

    Science.gov (United States)

    Mondal, Krishanu; Seth, Anju; Marwaha, Raman K; Dhanwal, Dinesh; Aneja, Satinder; Singh, Ritu; Sonkar, Pitambar

    2014-06-01

    Comparison of efficacy and safety of two different regimens of vitamin D-600 000 IU as a single intramuscular dose, and 60 000IU orally once a week for 10 weeks-in treatment of nutritional rickets. Children with nutritional rickets (age: 0.5-5 years, n = 61) were randomized to receive either 60 000IU vitamin D orally once a week for 10 weeks or 600 000IU single intramuscular injection. Serum calcium, phosphate, alkaline phosphatase, urinary calcium/creatinine ratio, serum 25 hydroxy vitamin D and radiological score were compared at 12-week follow-up. No difference was found in efficacy of the two regimens on comparing biochemical and radiological parameters. Serum 25 hydroxy vitamin D >100 ng/ml was found in two children in the oral group and one child in the intramuscular group. No child developed hypercalcemia or hypercalciuria after starting treatment. Staggered oral and one-time intramuscular administrations of 600 000IU vitamin D are equally effective and safe in treatment of nutritional rickets. © The Author [2014]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  12. Fractal analysis of nuclear histology integrates tumor and stromal features into a single prognostic factor of the oral cancer microenvironment

    International Nuclear Information System (INIS)

    The lack of prognostic biomarkers in oral squamous cell carcinoma (OSCC) has hampered treatment decision making and survival in OSCC remains poor. Histopathological features are used for prognostication in OSCC and, although useful for predicting risk, manual assessment of histopathology is subjective and labour intensive. In this study, we propose a method that integrates multiple histopathological features of the tumor microenvironment into a single, digital pathology-based biomarker using nuclear fractal dimension (nFD) analysis. One hundred and seven consecutive OSCC patients diagnosed between 1998 and 2006 in Calgary, Canada were included in the study. nFD scores were generated from DAPI-stained images of tissue microarray (TMA) cores. Ki67 protein expression was measured in the tumor using fluorescence immunohistochemistry (IHC) and automated quantitative analysis (AQUA®). Lymphocytic infiltration (LI) was measured in the stroma from haematoxylin-eosin (H&E)-stained TMA slides by a pathologist. Twenty-five (23.4%) and 82 (76.6%) patients were classified as high and low nFD, respectively. nFD was significantly associated with pathological tumor-stage (pT-stage; P = 0.01) and radiation treatment (RT; P = 0.01). High nFD of the total tumor microenvironment (stroma plus tumor) was significantly associated with improved disease-specific survival (DSS; P = 0.002). No association with DSS was observed when nFD of either the tumor or the stroma was measured separately. pT-stage (P = 0.01), pathological node status (pN-status; P = 0.02) and RT (P = 0.03) were also significantly associated with DSS. In multivariate analysis, nFD remained significantly associated with DSS [HR 0.12 (95% CI 0.02-0.89, P = 0.04)] in a model adjusted for pT-stage, pN-status and RT. We also found that high nFD was significantly associated with high tumor proliferation (P < 0.0001) and high LI (P < 0.0001), factors that we and others have shown to be associated with improved survival in OSCC

  13. Hepatic insulin sensitivity in healthy and prediabetic subjects: from a dual- to a single-tracer oral minimal model.

    Science.gov (United States)

    Visentin, Roberto; Dalla Man, Chiara; Basu, Rita; Basu, Ananda; Rizza, Robert A; Cobelli, Claudio

    2015-07-15

    Recently, a model was proposed to assess hepatic insulin sensitivity during a meal, i.e., the ability of insulin to suppress glucose production (EGP), SI (P). The model was developed on EGP data obtained from a triple-tracer meal and the tracer-to-tracee clamp technique and validated against the euglycemic hyperinsulinemic clamp. The aim of this study was to assess whether SI (P) can be obtained from plasma concentrations measured after a single-tracer meal by incorporating the above EGP model into the oral glucose minimal model by describing both glucose production and disposal (OMM(PD)). Triple-tracer meal data of two databases (20 healthy and 60 healthy and prediabetic subjects) were used. Virtually model-independent EGP estimates were calculated. OMM(PD) was identified on exogenous and endogenous glucose concentrations, providing indices of SI (P), disposal insulin sensitivity (SI (D)), and EGP. The model fitted the data well, and SI (P) and SI (D) were estimated with precision in both databases (SI (P) = 5.48 ± 0.54 10(-4) dl·kg(-1)·min(-1) per μU/ml and SI (D) = 9.93 ± 2.18 10(-4) dl·kg(-1)·min(-1) per μU/ml in healthy; SI (P) = 5.41 ± 3.55 10(-4) dl·kg(-1)·min(-1) per μU/ml and SI (D) = 5.34 ± 6.17 10(-4) dl·kg(-1)·min(-1) per μU/ml, in healthy and prediabetic subjects). Estimated SI (P) and that derived from the triple-tracer EGP model were very similar on average. Moreover, the time course of EGP normalized to basal EGP (EGPb), and EGP/EGPb agreed with the results obtained using the triple-tracer method. In this study, we have demonstrated that SI (P), SI (D), and EGP/EGPb time course can be estimated reliably from a single-tracer meal protocol in both healthy and prediabetic subjects. Copyright © 2015 the American Physiological Society.

  14. Morning Report: Can an Established Medical Education Tradition Be Validated?

    Science.gov (United States)

    McNeill, Matthew; Ali, Sayed K.; Banks, Daniel E.; Mansi, Ishak A.

    2013-01-01

    Background Morning report is accepted as an essential component of residency education throughout different parts of the world. Objective To review the evidence of the educational value, purpose, methods, and outcomes of morning report. Methods A literature search of PubMed, Ovid, and the Cochrane Library for English-language studies published between January 1, 1966, and October 31, 2011, was performed. We searched for keywords and Medical Subject Heading terms related to medical education, methods, attitudes, and outcomes in regard to “morning report.” Title and abstract review, followed by a full-text review by 3 authors, was performed to identify all pertinent articles. Results We identified 71 citations; 40 articles were original studies and 31 were commentaries, editorials, or review articles; 56 studies (79%) originated from internal medicine residency programs; 6 studies (8%) focused on ambulatory morning report; and 63 (89%) originated from the United States. Identified studies varied in objectives, methods, and outcome measures, and were not suitable for meta-analysis. Main outcome measures were resident satisfaction, faculty satisfaction, preparation for professional examinations, use of evidence-based medicine, clinical effects on patient care, adverse event detection, and utilization of a curriculum in case selection. Conclusions Morning report has heterogeneous purposes, methods, and settings. As an educational tool, morning report is challenging to define, its outcome is difficult to measure, and this precludes firm conclusions about its contribution to resident education or patient care. Residency programs should tailor morning report to meet their own unique educational objectives and needs. PMID:24404299

  15. Effect of single oral doses of sitagliptin, a dipeptidyl peptidase-4 inhibitor, on incretin and plasma glucose levels after an oral glucose tolerance test in patients with type 2 diabetes

    DEFF Research Database (Denmark)

    Herman, Gary A; Bergman, Arthur; Stevens, Catherine

    2006-01-01

    CONTEXT: In response to a meal, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) are released and modulate glycemic control. Normally these incretins are rapidly degraded by dipeptidyl peptidase-4 (DPP-4). DPP-4 inhibitors are a novel class of oral antihyperglyce......CONTEXT: In response to a meal, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) are released and modulate glycemic control. Normally these incretins are rapidly degraded by dipeptidyl peptidase-4 (DPP-4). DPP-4 inhibitors are a novel class of oral...... antihyperglycemic agents in development for the treatment of type 2 diabetes. The degree of DPP-4 inhibition and the level of active incretin augmentation required for glucose lowering efficacy after an oral glucose tolerance test (OGTT) were evaluated. OBJECTIVE: The objective of the study was to examine...... concentrations; and sitagliptin pharmacokinetics. RESULTS: Sitagliptin dose-dependently inhibited plasma DPP-4 activity over 24 h, enhanced active GLP-1 and GIP levels, increased insulin/C-peptide, decreased glucagon, and reduced glycemic excursion after OGTTs administered at 2 and 24 h after single oral 25...

  16. Screening in planarians identifies MORN2 as a key component in LC3-associated phagocytosis and resistance to bacterial infection.

    Science.gov (United States)

    Abnave, Prasad; Mottola, Giovanna; Gimenez, Gregory; Boucherit, Nicolas; Trouplin, Virginie; Torre, Cedric; Conti, Filippo; Ben Amara, Amira; Lepolard, Catherine; Djian, Benjamin; Hamaoui, Daniel; Mettouchi, Amel; Kumar, Atul; Pagnotta, Sophie; Bonatti, Stefano; Lepidi, Hubert; Salvetti, Alessandra; Abi-Rached, Laurent; Lemichez, Emmanuel; Mege, Jean-Louis; Ghigo, Eric

    2014-09-10

    Dugesia japonica planarian flatworms are naturally exposed to various microbes but typically survive this challenge. We show that planarians eliminate bacteria pathogenic to Homo sapiens, Caenorhabditis elegans, and/or Drosophila melanogaster and thus represent a model to identify innate resistance mechanisms. Whole-transcriptome analysis coupled with RNAi screening of worms infected with Staphylococcus aureus or Legionella pneumophila identified 18 resistance genes with nine human orthologs, of which we examined the function of MORN2. Human MORN2 facilitates phagocytosis-mediated restriction of Mycobacterium tuberculosis, L. pneumophila, and S. aureus in macrophages. MORN2 promotes the recruitment of LC3, an autophagy protein also involved in phagocytosis, to M. tuberculosis-containing phagosomes and subsequent maturation to degradative phagolysosomes. MORN2-driven trafficking of M. tuberculosis to single-membrane, LC3-positive compartments requires autophagy-related proteins Atg5 and Beclin-1, but not Ulk-1 and Atg13, highlighting the importance of MORN2 in LC3-associated phagocytosis. These findings underscore the value of studying planarian defenses to identify immune factors. Copyright © 2014 Elsevier Inc. All rights reserved.

  17. Morning vs evening dosing of the cathepsin K inhibitor ONO-5334: effects on bone resorption in postmenopausal women in a randomized, phase 1 trial.

    Science.gov (United States)

    Eastell, R; Dijk, D-J; Small, M; Greenwood, A; Sharpe, J; Yamada, H; Yuba, M; Tanimoto, M; Deacon, S

    2016-01-01

    The cathepsin K inhibitor, ONO-5334, improves bone mineral density in postmenopausal women with osteoporosis. The effects of morning versus evening administration of ONO-5334 were investigated by measuring bone turnover marker levels in healthy postmenopausal women. Morning administration of ONO-5334 showed a more consistent suppressive effect on bone resorption than evening administration. Bone turnover is thought to be subject to circadian variation, and the efficacy of osteoporosis treatments may be optimized by regulating the time of dosing. This study assessed whether evening administration of the cathepsin K inhibitor, ONO-5334, had a differential effect on the bone turnover marker, C-terminal telopeptide of type I collagen (CTX-I), compared with morning administration. This was a single-center, single blind crossover study. Fourteen healthy postmenopausal women were assigned to receive ONO-5334 150 mg once daily for 5 days in each period; they were randomized to receive either evening doses in the first period and morning doses in the second or vice versa. Serum and urinary levels of CTX-I were measured throughout the study. Both regimens showed similar patterns of reduction in serum and urinary CTX-I; however, CTX-I suppression was more consistently >60% over 24 h following morning administration. Morning administration led to 6% greater suppression of 24-h serum CTX-I area under the effect curve (AUE; 69 vs 63%; P morning administration, with mean trough concentrations for the morning and evening regimens at 9.4 and 4.0 ng/mL, respectively. There were no safety findings of concern. Morning dosing of ONO-5334 is more efficacious at reducing markers of bone turnover in healthy postmenopausal women than evening dosing. ClinicalTrials.gov: NCT01384188 , registered on June 27, 2011 EudraCT: 2008-006284-37.

  18. A Single Dose Oral Azithromycin versus Intramuscular Benzathine Penicillin for the Treatment of Yaws-A Randomized Non Inferiority Trial in Ghana.

    Science.gov (United States)

    Kwakye-Maclean, Cynthia; Agana, Nsiire; Gyapong, John; Nortey, Priscilia; Adu-Sarkodie, Yaw; Aryee, Esther; Asiedu, Kingsley; Ballard, Roland; Binka, Fred

    2017-01-01

    Yaws is a treponemal infection that was almost eradicated fifty years ago; however, the disease has re-emerged in a number of countries including Ghana. A single-dose of intramuscular benzathine penicillin has been the mainstay of treatment for yaws. However, intramuscular injections are painful and pose safety and logistical constraints in the poor areas where yaws occurs. A single center randomized control trial (RCT) carried out in Papua New Guinea in 2012 demonstrated the efficacy of a single-dose of oral azithromycin for the treatment of yaws. In this study, we also compared the efficacy of a single oral dose of azithromycin as an alternative to intramuscular benzathine penicillin for the treatment of the disease in another geographic setting. We conducted an open-label, randomized non-inferiority trial in three neighboring yaws-endemic districts in Southern Ghana. Children aged 1-15 years with yaws lesions were assigned to receive either 30mg/kg of oral azithromycin or 50,000 units/kg of intramuscular benzathine penicillin. The primary end point was clinical cure rate, defined as a complete or partial resolution of lesions 3 weeks after treatment. The secondary endpoint was serological cure, defined as at least a 4-fold decline in baseline RPR titre 6 months after treatment. Non- inferiority of azithromycin treatment was determined if the upper bound limit of a 2 sided 95% CI was less than 10%. The mean age of participants was 9.5 years (S.D.3.1, range: 1-15 years), 247(70%) were males. The clinical cure rates were 98.2% (95% CI: 96.2-100) in the azithromycin group and 96.9% (95% CI: 94.1-99.6) in the benzathine penicillin group. The serological cure rates at 6 months were 57.4% (95% CI: 49.9-64.9) in the azithromycin group and 49.1% (95% CI: 41.2-56.9) in the benzathine penicillin group, thus achieving the specified criteria for non-inferiority. A single oral dose of azithromycin, at a dosage of 30mg/kg, was non-inferior to a single dose of intramuscular

  19. Experience of morning reports in the emergency department.

    Science.gov (United States)

    Sabbagh, C; Chaddad, M; El Rassy, E

    2015-07-01

    Morning report in the emergency medicine departments is an emerging teaching modality in the medicine curriculum. Our institution, Hotel-Dieu de France hospital, a multidisciplinary tertiary care university hospital affiliated to the Saint Joseph University of Medical Sciences, is the only hospital in Middle East to hold morning reports in the emergency department (ED). We evaluate the usefulness of the morning report as a pedagogic tool as it assesses the content, quality of the discussions, professionalism, leadership, participation and duration of the morning report. The particularity of this paper is that it takes into consideration the interns' input often under-recognised in the studies. An anonymous questionnaire was diffused to the residents and interns that rotated in the ED during the previous year. It consisted of seven multiple-choice questions to evaluate the quality of the presentations, targeted discussions, ethics and professionalism, evidence-based medicine, clinical reasoning, relation of cases to discussions and implication of the ED physician. Overall, of the 63 patients who answered the survey, 65.1% were satisfied by the content. The majority considered the quality of the discussions acceptable and the leadership and participation satisfactory, professionalism was judged poor. Both residents and interns were satisfied of the teaching point of the morning reports. The only fail back observed was professionalism and pathophysiological discussions that require to be added to the sessions, whereas clinical management, teaching points, leadership and time management were completely satisfactory. © 2015 Royal Australasian College of Physicians.

  20. Comparative pharmacokinetics and bioavailability of tylosin tartrate and tylosin phosphate after a single oral and i.v. administration in chickens.

    Science.gov (United States)

    Ji, L-W; Dong, L-L; Ji, H; Feng, X-W; Li, D; Ding, R-L; Jiang, S-X

    2014-06-01

    The pharmacokinetics and oral bioavailability of tylosin tartrate and tylosin phosphate were carried out in broiler chickens according to a principle of single dose, random, parallel design. The two formulations of tylosin were given orally and intravenously at a dose level of 10 mg/kg b.w to chicken after an overnight fasting (n = 10 chickens/group). Serial blood samples were collected at different time points up to 24 h postdrug administration. A high performance liquid chromatography method was used for the determination of tylosin concentrations in chicken plasma. The tylosin plasma concentration's time plot of each chicken was analyzed by the 3P97 software. The pharmacokinetics of tylosin was best described by a one-compartmental open model 1st absorption after oral administration. After intravenous administration the pharmacokinetics of tylosin was best described by a two-compartmental open model, and there were no significant differences between tylosin tartrate and tylosin phosphate. After oral administration, there were significant differences in the Cmax (0.18 ± 0.01, 0.44 ± 0.09) and AUC (0.82 ± 0.05, 1.57 ± 0.25)between tylosin phosphate and tylosin tartrate. The calculated oral bioavailability (F) of tylosin tartrate and tylosin phosphate were 25.78% and 13.73%, respectively. Above all, we can reasonably conclude that, the absorption of tylosin tartrate is better than tylosin phosphate after oral administration. © 2013 John Wiley & Sons Ltd.

  1. Morning Versus Evening Bright Light Treatment at Home to Improve Function and Pain Sensitivity for Women with Fibromyalgia: A Pilot Study.

    Science.gov (United States)

    Burgess, Helen J; Park, Margaret; Ong, Jason C; Shakoor, Najia; Williams, David A; Burns, John

    2017-01-01

    To test the feasibility, acceptability, and effects of a home-based morning versus evening bright light treatment on function and pain sensitivity in women with fibromyalgia. A single blind randomized study with two treatment arms: 6 days of a 1 hour morning light treatment or 6 days of a 1 hour evening light treatment. Function, pain sensitivity, and circadian timing were assessed before and after treatment. Participants slept at home, except for two nights in Sleep Center. Ten women meeting the American College of Rheumatology's diagnostic criteria for fibromyalgia, including normal blood test results. Self-reported function was assessed with the Fibromyalgia Impact Questionnaire (FIQ). Pain sensitivity was assessed using a heat stimulus that gave measures of threshold and tolerance. Circadian timing was assessed with the dim light melatonin onset. Both morning and evening light treatments led to improvements in function and pain sensitivity. However, only the morning light treatment led to a clinically meaningful improvement in function (>14% reduction from baseline FIQ) and morning light significantly increased pain threshold more than evening light ( P  pain tolerance (r = 0.67, P  fibromyalgia. Those who undergo morning light treatment may show improvements in function and pain sensitivity. Advances in circadian timing may be one mechanism by which morning light improves pain sensitivity. Findings can inform the design of a randomized controlled trial. © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  2. Effects of early morning care, named "Comfort upon Rising" care, on postoperative orthopedic ambulation and morning activity.

    Science.gov (United States)

    Ohashi, Kumiko

    2014-10-01

    To examine the effects of "Comfort upon Rising" care (CUR) as a new type of early morning care. This was a quasi-experimental study using a convenience sampling and non-random assignment of 80 orthopedic postoperative inpatients needing ambulation assistance. The intervention group of 40 inpatients was given CUR designed to support the patients' needs. The control group of 40 inpatients was given conventional early morning care (CMC). Floor nurses conducted either CMC or CUR for subjects beginning the morning after surgery and continuing for 3 days. Mood was measured by the Wake-up Questionnaire (question I) and Profile of Mood States (POMS). Morning activities, which were daily living activities, breakfast behaviors including breakfast intake rate, were measured by Wake-up Questionnaire (question IV) and observation. Completing the study were 36 patients from the control group and 36 patients from the intervention group. Mood and activities in the morning were improved in the CUR group. CUR is a patient-centered care based on patients' individual needs and promotes self-care. CUR is more effective than CMC in promoting natural recovery after an operation. © 2013 The Author. Japan Journal of Nursing Science © 2013 Japan Academy of Nursing Science.

  3. Oral ketotifen and topical antibiotic therapy in the management of pruritus in prurigo nodularis: A randomized, controlled, single-blind, parallel study

    Directory of Open Access Journals (Sweden)

    Ashimav Deb Sharma

    2013-01-01

    Full Text Available Aims: To evaluate the role of oral ketotifen and topical antibiotic therapy in the management of pruritus in prurigo nodularis (PN patients. Materials and Methods: Twenty-seven patients with PN and a history of atopy with raised IgE were included in this study in a dermatology clinic. All patients had positive growth of Staphylococcus aureus on the lesional skin swab. All patients received topical halobetasol and oral hydroxyzine for 4 weeks. In addition, all patients in the study group received oral ketotifen and topical antibiotic therapy for 4 weeks. Randomization was performed by using a table of random numbers, and the participants were randomly allocated to one of the two groups in the study. The study was a single-blind study, and the blinding was done by the investigator. Results: Of the 14 patients in the study group, 9 had complete relief from pruritus by the end of first week, which was maintained till the end of 4 weeks. In the control group, mild to moderate reduction in the intensity of pruritus in the PN lesions of all patients were noted by the end of the first week. No further improvement in the level of pruritus was noted in the participants during the trial period. The treatment was well tolerated by the patients, and the adverse reactions of drugs were minimal in both groups. Conclusions: This study showed that oral ketotifen and topical antibiotic therapy can be helpful in the management of pruritus in PN patients.

  4. Functional outcomes and quality of life after a 6-month early intervention program for oral cancer survivors: a single-arm clinical trial

    Directory of Open Access Journals (Sweden)

    Yueh-Hsia Chen

    2018-02-01

    Full Text Available Background Advanced treatment of oral cancer increases survival rates; however, it also increases the risk of developing shoulder dysfunction, dysphagia, oral dysfunction, donor site morbidity and psychological issues. This single-arm preliminary pilot study aims to explore the effects of a six-month early intervention program following reconstructive surgery in oral cancer survivors. Methods A total of 65 participants were analyzed following reconstructive surgery. Outcome measurements were taken during the first visit, and at one, three and six months after reconstructive surgery. Results Scapular muscle strength and shoulder range of motion progressively improved during the 6-month follow-up. The mean Disability of the Arms, Shoulder and Hand (DASH score showed significant improvement at 1 month (p < .001. Health related QoL showed significant differences between baseline and 6-months post-surgery scores on global health and on most of the function and symptom scales. The predicted return-to-work rate was 80% at one year after the operation. Return-to-work rate differs in different vocational types, with a higher rate of return in the skilled or semi-skilled (87.5% and self-employed (86.7%. Conclusions We suggest that early integrated intervention program with a follow-up of at least six months following reconstructive surgery may help develop and identify intervention guidelines and goals in the initial six months of treatment following neck dissection in oral cancer survivors.

  5. Salivary cortisol, alpha-amylase and immunoglobulin a responses to a morning session of basketball or volleyball training in boys aged 14-18 years.

    Science.gov (United States)

    Bruzda-Zwiech, A; Konieczka, M; Hilt, A; Daszkowska, M; Grzegorczyk, J; Szczepańska, J

    2017-01-01

    This study investigates whether a single session of routine morning basketball or volleyball training affects saliva levels of cortisol, alpha-amylase (sAA) and secretory immunoglobulin A (sIgA) in boys aged 14–18 years. Twenty-nine boys who participate in basketball or volleyball training, recruited from the Marcin Gortat’s Athletic Championship School in Lodz, were enrolled in the study. The 90-minute routine exercise program included 15 minutes of warm-up followed by basketball or volleyball practice. Unstimulated saliva samples were collected prior to and immediately after the exercise, and were analysed using ELISA. One training session resulted in a significant increase of sAA concentration in all participants, as well as in the volleyball and basketball subgroups (p=0.00022; p=0.0029; p=0.0011; respectively). Post-exercise cortisol levels were significantly lower than pre-exercise levels (p=0.00002) throughout the group, as well as in the volleyball and basketball subgroups (p=0.0048; p=0.0019; p=0.0048; respectively). The exercise protocol did not significantly affect sIgA level, either in the whole examined group or the volleyball subgroup, however a weak significant increase of sIgA was observed in the basketball subgroup (p=0.046). The routine morning training session comprising a warm-up followed by basketball or volleyball practice seems to activate the sympatho-adrenal-medullary system, with a subsequent increase of alpha-amylase, but does not affect oral immunity in 14-18-year-old boys.

  6. Evaluation of DNA damage in oral precancerous and squamous cell carcinoma patients by single cell gel electrophoresis

    Directory of Open Access Journals (Sweden)

    Sanjit Mukherjee

    2011-01-01

    Materials and Methods: Peripheral blood was collected by venepuncture and comet assay was performed using SCGE. Mean tail length was compared between diagnostic groups and between different oral habit groups using t-tests and analysis of variance (ANOVA. Pearson′s product moment correlation was used to examine the linear association between the extent of DNA damage and oral habit pack-years. Scheffe′s pair-wise test was employed to adjust for multiple comparisons. Results: None of the controls were associated with any oral habits. Mean (±SD tail lengths (in mm for cancer (24.95 ± 5.09 and leukoplakia (12.96 ± 2.68 were significantly greater than in controls (8.54 ± 2.55, P<0.05. After adjustment, well-, moderately, and poorly differentiated carcinomas had significantly greater tail length than controls. Whereas the extent of DNA damage in cancer cases was significantly greater in leukoplakia than in compared to OSMF (11.03 ± 5.92, the DNA damage in latter was not different from controls. DNA damage for people with any oral habit (19.78 ± 7.77 was significantly greater than those with no habits (8.54 ± 2.55; P<0.0001. Conclusions: DNA damage measured by SCGE is greater in leukoplakia and squamous cell carcinoma, but not in OSMF. Deleterious oral habits are also associated with greater DNA damage.

  7. Renal-protective effects of n-hexane layer from morning glory seeds ethanol extract.

    Science.gov (United States)

    Shao, Yanli; Park, Bongkyun; Song, Yoon-Jae; Park, Dae Won; Sohn, Eun-Hwa; Kang, Se Chan

    2017-11-01

    Nephrotoxicity is a main problem in cancer patients using cisplatin. Oxidative stress, inflammation and apoptosis are the important mechanisms of cisplatin induced nephrotoxicity. In the present study, we investigated the effect of the extracts of morning glory on nephrotoxicity by cisplatin in human embryonic kidney cells 293 (HEK-293) and mice. Previous studies have reported that morning glory extracts showed potent activity on anti-inflammatory and anti-oxidant. However, the protective effects of the n-hexane layer of morning glory seed (MGs-Hx) on nephrotoxicity and its mechanisms have not been clearly understood. Oral administration with MGs-Hx showed protective effects in vivo experiments test and the treatment of MGs-Hx in a concentration of 100mg/kg/day had significant effect both of decreasing serum creatinine, BUN, serum uric acid level and reduced iNOS, COX-2 mRNA expressions with low side-effect. Moreover, cell viability was restored by MGs-Hx treatment compared to cisplatin-induced nephrotoxic HEK-293 cells. Co-treatment with MGs-Hx and cisplatin showed the significant effect to reduce inflammatory enzyme, iNOS expression and continuous production of NO. In addition, it exhibited a tendency to decreasing expression of apoptosis-related proteins, caspase-3, 8 and 9, and NF-κB translocation to nucleus as well as phosphorylation of p38, JNK, ERK in cisplatin-induced nephrotoxic HEK-293 cells. Our study provides insight into the underlying mechanisms of MGs-Hx and suggests that MGs-Hx might be a potential therapeutic agent to modulate inflammation and apoptosis in nephrotoxicity. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  8. The efficacy of amine fluoride/stannous fluoride in the suppression of morning breath odour.

    Science.gov (United States)

    Quirynen, Marc; Avontroodt, Pieter; Soers, Catherine; Zhao, Hong; Pauwels, Martine; Coucke, Wim; van Steenberghe, Daniel

    2002-10-01

    Breath odour is a complaint encountered worldwide, often linked to microbial overload in the oral cavity. This double blind, crossover, randomised study assessed the efficacy of several antiseptic mouthrinses or slurry vs. a control solution in the prevention of morning bad breath during an experimental period of 7 days without mechanical plaque control. Sixteen dental students with a healthy periodontium abolished, after a thorough professional cleaning, all means of mechanical plaque control during five experimental periods of 7 days, interleaved by washout periods of at least 3 weeks. During each experimental period, as the only oral hygiene measure, the students rinsed twice a day with one of the following formulations (in a randomised order): a 0.2% chlorhexidine-alcohol mouthrinse (CHX-Alc), a 0.05% CHX + 0.05% cetylpyridinium chloride + 0.14% zinc lactate mouthrinse (CHX-CPC-Zn), an amine fluoride/stannous fluoride (125 ppm F-/125 ppm F-) containing mouthrinse (AmF/SnF2Mr), a slurry of a tooth paste (AmF/SnF2Sl) containing amine fluoride (350 ppm F-) and stannous fluoride (1050 ppm F-) and a placebo solution (placebo). At days 0, 3 and 7, morning breath was scored via VSC level measurements of the mouth air, and organoleptic ratings of the mouth air and tongue coating. At the same visits both the degree of gingival inflammation and the de novo plaque formation were rated. At the end of each period a questionnaire for subjective ratings was completed and microbiological samples were taken from the tongue dorsum, the saliva and the supragingival plaque for anaerobic and aerobic culturing. Although oral hygiene during the experimental periods was limited to rinsing, bad breath parameters systematically improved (P or= 0.5 log reduction with a superiority (P plaque formation was significantly (P products. The CHX-Alc solution scored significantly worse for the subjective evaluation (questionnaires) concerning taste and sensitivity of tongue). The results of this

  9. Once-daily omeprazole/sodium bicarbonate heals severe refractory reflux esophagitis with morning or nighttime dosing.

    Science.gov (United States)

    Orbelo, Diana M; Enders, Felicity T; Romero, Yvonne; Francis, Dawn L; Achem, Sami R; Dabade, Tushar S; Crowell, Michael D; Geno, Debra M; DeJesus, Ramona S; Namasivayam, Vikneswaran; Adamson, Steven C; Arora, Amindra S; Majka, Andrew J; Alexander, Jeffrey A; Murray, Joseph A; Lohse, Matthew; Diehl, Nancy N; Fredericksen, Mary; Jung, Kee Wook; Houston, Margaret S; O'Neil, Angela E; Katzka, David A

    2015-01-01

    Morning dose or twice-daily proton pump inhibitor (PPI) use is often prescribed to heal severe reflux esophagitis. Compare the effect of single dose morning (control arm) versus nighttime (experimental arm) omeprazole/sodium bicarbonate (Zegerid(®)) (IR-OME) on esophagitis and gastroesophageal reflux symptoms. Adult outpatients with Los Angeles grade C or D esophagitis were allocated to open-label 40 mg IR-OME once a day for 8 weeks in a prospective, randomized, parallel design, single center study. Esophagogastroduodenoscopy (EGD) and validated self-report symptom questionnaires were completed at baseline and follow-up. Intention-to-treat and per-protocol analyses were performed. Ninety-two of 128 (72 %) eligible subjects participated [64 (70 %) male, mean age 58 (range 19-86), median BMI 29 (range 21-51), 58 C:34 D]. Overall, 81 (88 %) subjects healed [n = 70 (76 %)] or improved [n = 11 (12 %)] erosions. There was no significant difference (morning vs. night) in mucosal healing [81 vs. 71 %, (p = 0.44)] or symptom resolution [heartburn (77 vs. 65 %, p = 0.12), acid regurgitation (82 vs. 73 %, p = 0.28)]. Prevalence of newly identified Barrett's esophagus was 14 % with half diagnosed only after treatment. Once-daily IR-OME (taken morning or night) effectively heals severe reflux esophagitis and improves GERD symptoms. Results support the clinical practice recommendation to repeat EGD after 8 weeks PPI therapy in severe esophagitis patients to assure healing and exclude Barrett's esophagus.

  10. Predictive Role of p53 Protein as a Single Marker or Associated to Ki67 Antigen in Oral Carcinogenesis

    OpenAIRE

    Montebugnoli, L.; Felicetti, L.; Gissi, D.B.; Cervellati, F.; Servidio, D.; Marchetti, C.; Prati, C.; Flamminio, F.; Foschini, M.P.

    2008-01-01

    p53 over-expression has been proposed as a reliable marker associated to oral carcinogenesis, although only about 50% of oral carcinomas (OSCC) are associated with p53 over-expression and even p53-negative lesions can progress to OSCC. The aim of the study was to determine whether the combination of p53 over-expression and p53 low-expression associated with Ki67 over-expression (high Ki67/p53 ratio) could lead to a more sensitive parameter. Immunohistochemical expression of Ki67 and p53 was m...

  11. Single cell migration in oral squamous cell carcinoma - possible evidence of epithelial-mesenchymal transition in vivo

    DEFF Research Database (Denmark)

    Jensen, David H; Reibel, Jesper; Mackenzie, Ian C

    2015-01-01

    BACKGROUND: The invasion of cancer cells into the surrounding normal tissue is one of the defining features of cancer. While the phenomena of tumour budding, epithelial-mesenchymal transition and the presence of myofibroblasts have independently been shown to be related to a poor prognosis of oral...... carcinomas, their relationship has not been examined in detail. METHODS: Paraffin-embedded tissues from 28 patients with oral squamous cell carcinomas were stained with antibodies to cytokeratin, α-SMA, vimentin, E-cadherin, N-cadherin and Twist and evaluated for their expression in relation to invasive...

  12. Benefit of losartan/hydrochlorothiazide-fixed dose combination treatment for isolated morning hypertension: The MAPPY study.

    Science.gov (United States)

    Kai, Hisashi; Ueda, Tamenobu; Uchiwa, Hiroki; Iwamoto, Yoshiko; Aoki, Yuji; Anegawa, Takahiro; Fukuda, Kenji; Fukumoto, Yoshihiro; Imaizumi, Tsutomu

    2015-01-01

    Morning hypertension is an established risk factor for cardiovascular events. In the Morning Hypertension and Angiotensin Receptor Blocker/Hydrochlorothiazide Combination Therapy (MAPPY) study, a 50-mg losartan/12.5-mg hydrochlorothiazide combination (Los/HCTZ) lowered morning blood pressure (BP) more effectively than 100-mg losartan (High-Los) in treated hypertensive patients with morning hypertension. The aim of this MAPPY study sub-analysis was to determine whether Los/HCTZ was effective for controlling isolated morning hypertension (morning BP ≥ 135/85 mmHg and evening BP morning and evening BP ≥ 135/85 mmHg), or both. Of the 110 patients studied, 25 (22.7%) had isolated morning hypertension, and 85 (77.3%) had sustained hypertension at baseline. After 3-month treatment, isolated morning hypertension developed into controlled hypertension (morning and evening BP morning and evening were: 81.8% and 21.4% in Los/HCTZ- and High-Los-treated isolated morning hypertension (p = 0.003), respectively; and 61.4% and 36.6% in Los/HCTX- and High-Los-treated sustained hypertension (p = 0.022), respectively. In conclusion, Los/HCTZ was effective for controlling both types of morning hypertension, especially isolated morning hypertension. Los/HCTZ was superior to High-Los in treating both types of morning hypertension.

  13. Safety and pharmacokinetics of single and multiple intravenous bolus doses of diclofenac sodium compared with oral diclofenac potassium 50 mg: A randomized, parallel-group, single-center study in healthy subjects.

    Science.gov (United States)

    Munjal, Sagar; Gautam, Anirudh; Okumu, Franklin; McDowell, James; Allenby, Kent

    2016-01-01

    In a randomized, parallel-group, single-center study in 42 healthy adults, the safety and pharmacokinetic parameters of an intravenous formulation of 18.75 and 37.5 mg diclofenac sodium (DFP-08) following single- and multiple-dose bolus administration were compared with diclofenac potassium 50 mg oral tablets. Mean AUC0-inf values for a 50-mg oral tablet and an 18.75-mg intravenous formulation were similar (1308.9 [393.0]) vs 1232.4 [147.6]). As measured by the AUC, DFP-08 18.75 mg and 37.5 mg demonstrated dose proportionality for extent of exposure. One subject in each of the placebo and DFP-08 18.75-mg groups and 2 subjects in the DFP-08 37.5-mg group reported adverse events that were considered by the investigator to be related to the study drug. All were mild in intensity and did not require treatment. Two subjects in the placebo group and 1 subject in the DFP-08 18.75-mg group reported grade 1 thrombophlebitis; no subjects reported higher than grade 1 thrombophlebitis after receiving a single intravenous dose. The 18.75- and 37.5-mg doses of intravenous diclofenac (single and multiple) were well tolerated for 7 days. Additional efficacy and safety studies are required to fully characterize the product. © 2015, The American College of Clinical Pharmacology.

  14. Randomised clinical trial on the effect of a single oral administration of l-tryptophan, at three dose rates, on reaction speed, plasma concentration and haemolysis in horses.

    Science.gov (United States)

    Noble, Glenys K; Li, Xiuhua; Zhang, Dagong; Sillence, Martin N

    2016-07-01

    Tryptophan (TRP) is marketed as a calmative for horses despite reservations about its efficacy. The aim of this study was to measure the effect of oral TRP administration on the reaction speed of horses. Sixty mature horses were used in a two stage randomised, blind, cross-over study, receiving a placebo and an oral dose of TRP (30, 60 or 120 mg/kg body weight), before undergoing a reaction speed test. Blood samples were taken up to 96 h after TRP administration, to identify signs of acute haemolytic anaemia. Plasma TRP concentrations were increased (P reaction speed of horses when startled. There was no evidence of alterations in clinical pathology parameters in 432 blood samples. While the safety of these doses of TRP can be confirmed, there was no evidence to suggest that a single dose of TRP is an effective calmative for horses. Copyright © 2016 Elsevier Ltd. All rights reserved.

  15. Morning versus evening induction of labour for improving outcomes

    NARCIS (Netherlands)

    Bakker, Jannet J. H.; van der Goes, Birgit Y.; Pel, Maria; Mol, Ben Willem J.; van der Post, Joris A. M.

    2013-01-01

    Background Induction of labour is a common intervention in obstetric practice. Traditionally, inmost hospitals induction of labour with medication starts early in the morning, with the start of the working day for the day shift. In human and animal studies spontaneous onset of labour is proven to

  16. Morning Exercise: Enhancement of Afternoon Sprint-Swimming Performance.

    Science.gov (United States)

    McGowan, Courtney J; Pyne, David B; Thompson, Kevin G; Raglin, John S; Rattray, Ben

    2017-05-01

    An exercise bout completed several hours prior to an event may improve competitive performance later that same day. To examine the influence of morning exercise on afternoon sprint-swimming performance. Thirteen competitive swimmers (7 male, mean age 19 ± 3 y; 6 female, mean age 17 ± 3 y) completed a morning session of 1200 m of variedintensity swimming (SwimOnly), a combination of varied-intensity swimming and a resistance-exercise routine (SwimDry), or no morning exercise (NoEx). After a 6-h break, swimmers completed a 100-m time trial. Time-trial performance was faster in SwimOnly (1.6% ± 0.6, mean ± 90% confidence limit, P confidence limit], P = .04), body (0.2°C ± 0.1°C, P = .02), and skin temperatures (0.3°C ± 0.3°C, P = .02) were higher in SwimDry than in NoEx. Completion of a morning swimming session alone or together with resistance exercise can substantially enhance sprint-swimming performance completed later the same day.

  17. A novel approach to treating morning sleep inertia in narcolepsy.

    Science.gov (United States)

    Bagai, Kanika; Malow, Beth A

    2010-02-15

    We describe an adolescent with narcolepsy who presented with inability to awaken from sleep to attend early morning classes at school. After he did not respond to traditional therapies, a nicotine patch was prescribed with success. We present our experience with this unconventional treatment, which may benefit others with inability to awaken from sleep that is refractory to standard treatments.

  18. A Novel Approach to Treating Morning Sleep Inertia in Narcolepsy

    OpenAIRE

    Bagai, Kanika; Malow, Beth A.

    2010-01-01

    We describe an adolescent with narcolepsy who presented with inability to awaken from sleep to attend early morning classes at school. After he did not respond to traditional therapies, a nicotine patch was prescribed with success. We present our experience with this unconventional treatment, which may benefit others with inability to awaken from sleep that is refractory to standard treatments.

  19. Comparison between single PCR and nested PCR in detection of human papilloma viruses in paraffin-embedded OSCC and fresh oral mucosa.

    Science.gov (United States)

    Jalouli, Miranda; Jalouli, Jamshid; Ibrahim, Salah O; Hirsch, Jan-Michaél; Sand, Lars

    2015-01-01

    Infection with human papilloma virus (HPV) has been implicated as one of the risk factors for the development of oropharyngeal cancer. Many different HPV tests exist, and information regarding their specific technical, analytical, and clinical properties is increasing. This study aimed to compare the level of detection of HPV using two reliable polymerase chain reaction (PCR) methods, nested PCR (NPCR) and single PCR (SPCR), in archival paraffin-embedded oral squamous cell carcinoma (OSCC) samples and fresh oral mucosa specimens. The presence of HPV genome in two groups of tissue samples was analyzed: (i) 57 paraffin-embedded OSCC samples from Sudan and (ii) eight healthy fresh oral mucosal samples from Swedish volunteers. The specimens were tested by SPCR with primer pair MY9/MY11 and NPCR using GP5+/GP6+ primer sets. Eighteen (32%) out of the 57 paraffin-embedded OSCC samples, and five (62%) out of the eight fresh clinically healthy samples were found to be HPV-positive with NPCR. With SPCR, four (7%) out of the paraffin-embedded OSCC samples were HPV-positive. A statistically significant difference between HPV-positive and -negative samples was found when comparing NPCR and SPCR in OSCC and fresh oral mucosa (p<0.0001). The comparative test between SPCR and NPCR showed 100% sensitivity and 69% specificity for OSCC. The use of the GP5+/GP6+ nested PCR increased the positivity rate, efficiency rate and sensitivity of HPV detection in oral samples significantly and should be considered as the method of choice. Copyright © 2015 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

  20. Effect of a single oral dose of milrinone on left ventricular diastolic performance in the failing human heart

    NARCIS (Netherlands)

    F. Piscione; B.E. Jaski; G.J. Wenting (Gert); P.W.J.C. Serruys (Patrick)

    1987-01-01

    textabstractIn 14 patients with severe congestive heart failure, left ventricular pressure (measured by tip manometer) and derived variables were measured before and every 10 minutes after administration of oral milrinone (10 mg) for 50 minutes along with measurements of coronary sinus blood flow

  1. The oral immunogenicity of BioProtein, a bacterial single-cell protein, is affected by its particulate nature

    DEFF Research Database (Denmark)

    Christensen, Hanne Risager; Larsen, L.C.; Frøkiær, Hanne

    2003-01-01

    -culture homogenate induced immunoglobulin A in saliva but there was no systemic response. The antibodies from BP-fed mice cross-reacted with BP-culture homogenate revealing the presence of the same antigenic components in the two products despite the different oral immunogenicity. Thus, ingestion of BP induces...

  2. Plasma concentrations of fenbendazole (FBZ and oxfendazole in alpacas (Lama pacos after single intravenous and oral dosing of FBZ

    Directory of Open Access Journals (Sweden)

    Lakritz J

    2015-02-01

    Full Text Available Jeffrey Lakritz,1 Daniel Linden,2 David E Anderson,3 Terri A Specht4 1Department of Veterinary Clinical Sciences, College of Veterinary Medicine, The Ohio State University, Columbus, OH, USA; 2Department of Agriculture and Engineering Technologies, College of Food, Agriculture and Environmental Sciences, The Ohio State University, Wooster, OH, USA; 3Department of Large Animal Clinical Sciences, College of Veterinary Medicine, University of Tennessee, Knoxville, TN, USA; 4Four Star Veterinary Service, Chickasaw, OH, USA Abstract: The objective of this study was to determine plasma pharmacokinetics and bioavailability of fenbendazole (FBZ and oxfendazole (OFZ after intravenous (iv and oral administrations of FBZ (5 mg/kg to alpacas. Plasma concentrations of FBZ and OFZ after administration of FBZ iv and orally (5 mg/kg were determined by high-performance liquid chromatography with ultraviolet detection. Total clearance (CL of FBZ was 16.5±4 mL/kg/min (range: 4–31 mL/kg/min, and steady-state volume of distribution (Vdss was 3.3±1 L/kg (range: 1.7–7.4 L/kg. The terminal phase half-life of FBZ after iv administration was 5.9±3.8 hours (range: 0.8–20 hours. After oral administration, the FBZ terminal phase half-life was 23±5 hours (range: 9–37 hours and the systemic bioavailability of FBZ was 16%±6% (range: 1%–41%. Peak FBZ concentrations after oral administration were 0.13±0.05 µg/mL (range: 0.05–0.28 µg/mL at 10 hours (range: 8–12 hours. Peak plasma OFZ concentrations after oral dosing with FBZ (5 mg/kg were 0.14±0.05 µg/mL (0.05–0.3 µg/mL at 24±7 hours (range: 12–48 hours. FBZ clearance is lower in comparison to that of other species. Systemic availability of FBZ after oral administration is low after oral dosing. Metabolites of FBZ produced by alpacas are similar to those observed in other species. Keywords: bioavailability, benzimidazoles, camelid, pharmacokinetics

  3. The single mandibular implant study - Short-term effects of the loading protocol on Oral Health-related Quality of Life.

    Science.gov (United States)

    Schwindling, Franz Sebastian; Raedel, Michael; Passia, Nicole; Freitag-Wolf, Sandra; Wolfart, Stefan; Att, Wael; Mundt, Torsten; Reissmann, Daniel; Ismail, Fadi; von Königsmark, Valerie; Kern, Matthias

    2018-02-02

    A single implant can be placed to retain an overdenture in the edentulous mandible. This study aimed at the development of Oral Health-related Quality of Life comparing immediate and delayed implant loading, i.e., loading after 3 months of submerged healing. In a randomized controlled trial, 158 participants received a single mandibular implant in the midline. Quality of life was measured using the summary score of the German 49-item Oral Health Impact Profile at baseline, one month after implant placement (direct loading group) as well as one and four months after loading. Mean scores at baseline were comparable. Four months after implantation, a decrease of mean scores was recognized for both groups, indicating a significantly enhanced quality of life after treatment. When comparing the groups after both 1 and 4 months of loading, quality of life was insignificantly higher in the delayed loading group (1 month: 42.1 vs. 32.3; 4 months: 33.6 vs. 27.7). For immediate loading, an insignificant tendency to an earlier improvement was recognized (Δ 1month-baseline : 9.7, compared to Δ 1month-baseline : 6.4). The single mandibular implant concept was associated with a positive impact on quality of life. However, no statistically significant influence of implant loading on quality of life was found. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  4. Challenging the neuronal MIBG uptake by pharmacological intervention: effect of a single dose of oral amitriptyline on regional cardiac MIBG uptake

    Energy Technology Data Exchange (ETDEWEB)

    Estorch, Montserrat; Carrio, Ignasi; Mena, Esther; Flotats, Albert; Camacho, Valle; Fuertes, Jordi [Autonomous University of Barcelona, Department of Nuclear Medicine, Hospital Sant Pau, Barcelona (Spain); Kulisewsky, Jaume [Autonomous University of Barcelona, Department of Neurology, Hospital Sant Pau, Barcelona (Spain); Narula, Jagat [Irvine College of Medicine, Division of Cardiology, University of California, Irvine, CA (United States)

    2004-12-01

    Imaging with metaiodobenzylguanidine (MIBG) is used for the assessment of neuronal dysfunction in various cardiovascular disorders. Although valuable information is obtained by resting MIBG imaging, it is conceivable that competitive interference with the re-uptake mechanism would exaggerate MIBG defects and might unmask subclinical neuronal dysfunction. Tricyclic antidepressants, such as amitriptyline, have been reported to significantly increase cardiac MIBG washout and inhibit uptake into presynaptic neurons. This study was undertaken to assess whether a single oral dose of amitriptyline could influence cardiac MIBG distribution. Six patients (aged 62-81 years; four males, two females) who had demonstrated a normal cardiac MIBG scan during work-up for movement disorders were studied. The patients underwent a second {sup 123}I-MIBG study after oral administration of 25 mg amitriptyline within 1 week. Single-photon emission computed tomography images were acquired at 4 h to assess the regional distribution of MIBG, after generation of polar maps and employing a 20-segment model. Mean percentage of peak activity was calculated for each segment at rest and after amitriptyline administration. After amitriptyline administration, there was a decrease in regional MIBG uptake in 10{+-}4 segments per patient [62/120 segments (52%): 37 segments with a 5-10% decrease, 25 segments with a >10% decrease]. This change was statistically significant in lateral (P=0.003), apical (P<0.0001) and inferior (P=0.03) regions. A single oral dose of amitriptyline can induce changes in the uptake and retention of cardiac MIBG, indicating the feasibility of use of pharmacological intervention in cardiac neurotransmission imaging. (orig.)

  5. Antimalarial iron chelator, FBS0701, shows asexual and gametocyte Plasmodium falciparum activity and single oral dose cure in a murine malaria model.

    Directory of Open Access Journals (Sweden)

    Patricia Ferrer

    Full Text Available Iron chelators for the treatment of malaria have proven therapeutic activity in vitro and in vivo in both humans and mice, but their clinical use is limited by the unsuitable absorption and pharmacokinetic properties of the few available iron chelators. FBS0701, (S3"-(HO-desazadesferrithiocin-polyether [DADFT-PE], is an oral iron chelator currently in Phase 2 human studies for the treatment of transfusional iron overload. The drug has very favorable absorption and pharmacokinetic properties allowing for once-daily use to deplete circulating free iron with human plasma concentrations in the high µM range. Here we show that FBS0701 has inhibition concentration 50% (IC(50 of 6 µM for Plasmodium falciparum in contrast to the IC(50 for deferiprone and deferoxamine at 15 and 30 µM respectively. In combination, FBS0701 interfered with artemisinin parasite inhibition and was additive with chloroquine or quinine parasite inhibition. FBS0701 killed early stage P. falciparum gametocytes. In the P. berghei Thompson suppression test, a single dose of 100 mg/kg reduced day three parasitemia and prolonged survival, but did not cure mice. Treatment with a single oral dose of 100 mg/kg one day after infection with 10 million lethal P. yoelii 17XL cured all the mice. Pretreatment of mice with a single oral dose of FBS0701 seven days or one day before resulted in the cure of some mice. Plasma exposures and other pharmacokinetics parameters in mice of the 100 mg/kg dose are similar to a 3 mg/kg dose in humans. In conclusion, FBS0701 demonstrates a single oral dose cure of the lethal P. yoelii model. Significantly, this effect persists after the chelator has cleared from plasma. FBS0701 was demonstrated to remove labile iron from erythrocytes as well as enter erythrocytes to chelate iron. FBS0701 may find clinically utility as monotherapy, a malarial prophylactic or, more likely, in combination with other antimalarials.

  6. Data on a single oral dose of camu camu (Myrciaria dubia pericarp extract on flow-mediated vasodilation and blood pressure in young adult humans

    Directory of Open Access Journals (Sweden)

    Tadayoshi Miyashita

    2018-02-01

    Full Text Available This data article describes the flow-mediated vasodilation (FMD responses, represented by changes in arterial diameter, and blood pressure changes in young adults after a single oral dose of camu camu (Myrciaria dubia pericarp extract or placebo (cross-over design. Ten healthy men and 10 healthy women participated in this study. Ultrasonic diagnostic equipment was used to monitor arterial diameter changes, indicative of FMD, for 110 s after the administration of the camu camu extract or placebo. In addition, the systolic and diastolic blood pressure values were recorded.

  7. Concurrent administration of donepezil HCl and sertraline HCl in healthy volunteers: assessment of pharmacokinetic changes and safety following single and multiple oral doses

    Science.gov (United States)

    Nagy, Christa F; Kumar, Dinesh; Perdomo, Carlos A; Wason, Suman; Cullen, Edward I; Pratt, Raymond D

    2004-01-01

    Aim This study evaluated the safety and pharmacokinetics (PK) of donepezil HCl and sertraline HCl when administered separately and in combination. Methods This was a randomized, open-label, three-period crossover study. In consecutive dosing periods separated by washout periods of ≥3 weeks, healthy volunteers received either oral donepezil HCI 5 mg once daily for 15 days, oral sertraline HCl 50 mg once daily for 5 days followed by 10 days of once-daily sertraline HCl 100 mg, or the simultaneous administration of oral donepezil HCl and sertraline HCl. Plasma donepezil and sertraline concentrations were determined by high performance liquid chromatography/mass spectrometry. Safety was evaluated by physical and laboratory evaluations and the monitoring of adverse events (AEs). Results A total of 19 volunteers (16 male and three female) were enrolled. Three male subjects withdrew from the study prematurely due to AEs (one case of nausea/stomach cramps and one case of eosinophilia during combination treatment, and one upper respiratory tract infection during treatment with sertraline HCl alone). In subjects who completed all three treatment periods (n = 16), the concurrent administration of donepezil HCl and sertraline HCl did not alter the steady-state (day 15) PK parameters of donepezil HCl. A small (<12%) but statistically significant (P = 0.02) increase in donepezil Cmax was seen after single doses of sertraline HCl and donepezil HCl on day 1 but this was not thought to be clinically meaningful. No significant differences in the tmax or AUC0–24 h of donepezil were observed between the donepezil HCl only or donepezil HCl plus sertraline HCl groups on day 1. No significant changes in sertraline PK parameters were observed either on day 1 (single dose) or on day 15 (steady state) when sertraline HCl was co-administered with donepezil HCl. Generally, the concurrent administration of donepezil HCl and sertraline HCl was well tolerated, with no serious AEs reported

  8. The effect of single oral doses of duloxetine, reboxetine, and midodrine on the urethral pressure in healthy female subjects, using urethral pressure reflectometry

    DEFF Research Database (Denmark)

    Klarskov, Niels; Cerneus, Dirk; Sawyer, William

    2018-01-01

    AIMS: To evaluate the effect on urethral pressure of reference drugs known to reduce stress urinary incontinence symptoms by different effect size and mechanisms of action on urethral musculature under four test conditions in healthy female subjects using urethral pressure reflectometry. METHODS......: Healthy females aged 18-55 years were recruited by advertising for this phase 1, single site, placebo-controlled, randomized, four-period, crossover study. The interventions were single oral doses of 10 mg Midodrine, 80 mg Duloxetine, 12 mg Reboxetine, and placebo. The endpoints were the opening urethral...... pressure measured in each period at four time points (predose and 2, 5.5, and 9 h after dosing). RESULTS: Twenty-nine females were enrolled; 25 randomized and 24 completed the study. The opening urethral pressure was higher in all measurements with filled bladder compared with empty bladder, and during...

  9. Comparison of split-dosing vs non-split (morning) dosing regimen for assessment of quality of bowel preparation for colonoscopy.

    Science.gov (United States)

    Shah, Hardik; Desai, Devendra; Samant, Hrishikesh; Davavala, Sandeep; Joshi, Anand; Gupta, Tarun; Abraham, Philip

    2014-12-16

    To compare (using the Ottawa Bowel Preparation Scale) the efficacy of split-dose vs morning administration of polyethylene glycol solution for colon cleansing in patients undergoing colonoscopy, and to assess the optimal preparation-to-colonoscopy interval. Single-centre, prospective, randomized, investigator-blind stud in an academic tertiary-care centre. Two hundred patients requiring elective colonoscopy were assigned to receive one of the two preparation regimens (split vs morning) prior to colonoscopy. Main outcome measurements were bowel preparation quality and patient tolerability. Split-dose regimen resulted in better bowel preparation compared to morning regimen [Ottawa score mean 5.52 (SD 1.23) vs 6.02 (1.34); P = 0.017]. On subgroup analysis, for afternoon procedures, both the preparations were equally effective (P = 0.756). There was no difference in tolerability and compliance between the two regimens. Overall, previous evening - same morning split-dosing regimen results in better bowel cleansing for colonoscopy compared to morning preparation. For afternoon procedures, both schedules are equally effective; morning preparation may be more convenient to the patient.

  10. Comparison of split-dosing vs non-split (morning) dosing regimen for assessment of quality of bowel preparation for colonoscopy

    Science.gov (United States)

    Shah, Hardik; Desai, Devendra; Samant, Hrishikesh; Davavala, Sandeep; Joshi, Anand; Gupta, Tarun; Abraham, Philip

    2014-01-01

    AIM: To compare (using the Ottawa Bowel Preparation Scale) the efficacy of split-dose vs morning administration of polyethylene glycol solution for colon cleansing in patients undergoing colonoscopy, and to assess the optimal preparation-to-colonoscopy interval. METHODS: Single-centre, prospective, randomized, investigator-blind stud in an academic tertiary-care centre. Two hundred patients requiring elective colonoscopy were assigned to receive one of the two preparation regimens (split vs morning) prior to colonoscopy. Main outcome measurements were bowel preparation quality and patient tolerability. RESULTS: Split-dose regimen resulted in better bowel preparation compared to morning regimen [Ottawa score mean 5.52 (SD 1.23) vs 6.02 (1.34); P = 0.017]. On subgroup analysis, for afternoon procedures, both the preparations were equally effective (P = 0.756). There was no difference in tolerability and compliance between the two regimens. CONCLUSION: Overall, previous evening - same morning split-dosing regimen results in better bowel cleansing for colonoscopy compared to morning preparation. For afternoon procedures, both schedules are equally effective; morning preparation may be more convenient to the patient. PMID:25512770

  11. Exploring the Effects of Using an Oral Appliance to Reduce Movement Dysfunction in an Individual With Parkinson Disease: A Single-Subject Design Study.

    Science.gov (United States)

    Lane, Hillary; Rose, Lindsey E; Woodbrey, Megan; Arghavani, David; Lawrence, Michael; Cavanaugh, James T

    2017-01-01

    Clinical reports suggest that wearing an oral appliance can improve the gait and balance of an individual with Parkinson disease (PD). Our primary purpose was to systematically explore this effect using a single-subject study design and quantitative motion analysis. Secondarily, we sought to examine the quality-of-life outcomes following 1-month of routine oral appliance wear. The participant was a 73-year-old ambulatory man with mid-stage PD. Using an A-B-A design, for which a custom-made oral appliance served as the intervention, kinematic and kinetic data were captured during performance of Four Square Step Test, serpentine walk, and tandem walk tasks. Grip strength was quantified with a dynamometer. Quality-of-life outcomes were collected after 1 month of appliance wear using the Parkinson Disease Questionnaire-39 (PDQ-39). Perceived changes in balance, mobility, and quality of life were captured from the participant using an 11-point Global Rate of Change (GRC) scale. Changes in mobility, postural control, and grip strength during appliance wear were suggestive of reduced movement dysfunction. The PDQ-39 revealed a significant improvement in quality of life, primarily related to increased emotional well-being, decreased stigma, and increased communication. GRC scores indicated a clinically significant improvement in ease of movement in the community (+3), ease of movement during the performance of activities of daily living (+4), and in standing balance while performing activities of daily living (+4). Study findings provided quantitative evidence supporting the effectiveness of oral appliance wear for reducing movement dysfunction in a patient with mid-stage PD.Video Abstract available for more insights from the authors (see Supplemental Digital Content 1, http://links.lww.com/JNPT/A155).

  12. Sporadic Insulinoma Presenting as Early Morning Night Terrors.

    Science.gov (United States)

    Beisang, Daniel; Forlenza, Gregory P; Luquette, Mark; Sarafoglou, Kyriakie

    2017-06-01

    A 16-year-old boy with a recent diagnosis of night terrors was evaluated for recurrent early morning hypoglycemia after an early morning seizure. Evaluation in clinic with critical laboratories identified hyperinsulinemic hypoglycemia. Additional investigation revealed a sporadic insulinoma as the etiology of his hypoglycemia and all symptoms were resolved after pancreaticoduodenectomy. The importance of obtaining critical laboratory samples is highlighted and appropriate radiologic, medical, and pathologic testing is discussed. We additionally review the medical and surgical management of hyperinsulinemic hypoglycemia. A discussion of multiple endocrine neoplasia type 1 associated insulinomas is included as well. This case highlights the importance of considering hypoglycemia in the evaluation of night terrors and new-onset seizures. Copyright © 2017 by the American Academy of Pediatrics.

  13. Morning akinesia in Parkinson's disease: challenges and solutions

    Directory of Open Access Journals (Sweden)

    Tambasco N

    2016-06-01

    Full Text Available Nicola Tambasco,1 Simone Simoni,1 Pasquale Nigro,1 Federico Paolini Paoletti,1 Erica Marsili,1 Paolo Calabresi1,2 1Neurology Clinic, Azienda Ospedaliera – Università di Perugia, Perugia, 2Neurophysiology Department, IRCCS Fondazione Santa Lucia, Rome, Italy Abstract: Motor complications of Parkinson's disease (PD have been reported to occur after a few years of treatment with levodopa (L-dopa. Morning akinesia is a delayed ON of the first L-dopa daily dose, occurring in almost 60% of patients on dopaminergic treatment. This is primarily a motor symptom, but has been recently recognized as being correlated with nonmotor fluctuations. Sleep disorders and gastrointestinal dysfunction might be the underlying mechanisms. Over the past 30 years, several pharmacological and nonpharmacological approaches have been investigated. Keywords: Parkinson's disease, morning akinesia, motor fluctuation, L-dopa 

  14. Mediating effects of nocturnal blood pressure and morning surge on the contributions of arterial stiffness and sodium intake to morning blood pressure: A path analysis.

    Science.gov (United States)

    Lee, Hyung Tak; Park, Jin-Kyu; Choi, Sung Yong; Choi, Bo Youl; Kim, Mi Kyung; Mori, Mari; Yamori, Yukio; Lim, Young Hyo; Shin, Jinho

    2016-01-01

    The aim of this study was to evaluate the mediating effects of nocturnal blood pressure (BP) and morning surge on the contribution of arterial stiffness and sodium intake to morning BP in a middle-aged general population. The study included 124 subjects aged 30-59 years, from rural Yeoju County, Gyeonggi Province, South Korea. Ambulatory BP monitoring, 24 h urinary sodium excretion (24 h UNa) and brachial-ankle pulse wave velocity (baPWV) measurements were performed in all subjects. The mean ± SD age was 48.1 ± 8.2 years and the proportion of male subjects was 41.1%. After adjusting for covariates, morning systolic blood pressure (SBP) was significantly correlated with morning surge [coefficient = 0.761, 95% confidence interval (CI) 0.651-0.872, p morning SBP. The indirect effect mediated by nocturnal SBP was statistically significant (0.054, p = 0.005), but the indirect effect mediated by the morning surge was not significant. The 24 h UNa had no significant direct or indirect effects on morning SBP. baPWV had significant direct and indirect effects on morning SBP. The indirect effect was mediated by nocturnal SBP, but not by morning surge. The 24 h UNa had neither significant direct nor indirect effects on morning SBP.

  15. Clinical benefits of oral nutritional supplementation for elderly hip fracture patients: a single blind randomised controlled trial.

    Science.gov (United States)

    Myint, Ma Wai Wai; Wu, Jenny; Wong, Euann; Chan, Suk Ping; To, Tze Shing Jess; Chau, Mei Wa Rosanna; Ting, Kwai Hing; Fung, Pui Man; Au, Kit Sing Derrick

    2013-01-01

    malnutrition is an important risk factor for poor outcome in patients recovering after hip fracture surgery. This study aimed to investigate the clinical, nutritional and rehabilitation effects of an oral nutritional supplementation (ONS) in an inpatient rehabilitation setting. this was an observer-blinded randomised controlled trial of elderly post-surgical proximal femoral fracture patients. A ready-to-use oral liquid nutritional supplementation (18-24 g protein and 500 kcal per day) in addition to hospital diet was compared with hospital diet only. Both groups received usual rehabilitation therapy and oral calcium and vitamin D supplements. Outcomes were compared at discharge from rehabilitation and after 4 weeks of discharge. The primary outcome parameters were the serum albumin level, the body mass index (BMI), the functional independence measure (FIM) and the elderly mobility scale (EMS). Secondary outcome parameters were frequency of complications, inpatient length of stay, mortality and acute hospital use within 6 months after discharge. a total of 126 patients were recruited, 65 in the supplementation arm and 61 in the control arm. There was a significant difference in change in BMI with a decrease of 0.25 and 0.03 kg/m(2) in the ONS group and 0.72 and 0.49 kg/m(2) in the control group at hospital discharge and follow-up, respectively (P = 0.012). The length of stay in rehabilitation ward was shortened by 3.80 (SE = 1.81, P = 0.04) days favouring the ONS group. The total number of infection episodes was also reduced significantly. No difference was observed in the rate of change of the serum albumin level, the FIM and the EMS. clinical and nutritional benefits were seen in this trial but rehabilitation benefits could not be demonstrated.

  16. Effect of single oral dose of proanthocyanidin on postprandial hyperglycemia in healthy rats: A comparative study with sitagliptin.

    Directory of Open Access Journals (Sweden)

    Amal Ajaweed Sulaiman

    2014-04-01

    Result: Both proanthocyanidin and sitagliptin significanthly improve hyperglycemia induced by oral glucose load relative to control. While non significant changes was achieved by proanthocyanidin after intraperitoneal glucose challenge compared to untreated control group. Conclusion: The result of this study indicated that proanthocyanidin may possess an enhancement of incretin effect of gut peptides which could be responsible for some of its action on glucose homeostasis. This finding may provide opportunity for further pharmacological studies using more specific models to clarify the possible action of proanthocyanidin as a natural DPP-IV inhibitor. [J Intercult Ethnopharmacol 2014; 3(2.000: 73-77

  17. The polar cliff in the morning sector of the ionosphere

    Directory of Open Access Journals (Sweden)

    G. W. Prölss

    2013-05-01

    Full Text Available By "polar cliff" we mean the steep increase in the ionization density observed in the morning sector of the polar ionosphere. Here the properties of this remarkable feature are investigated. The data set consists of electron density and temperature measurements obtained by the Dynamics Explorer 2 satellite. Only data recorded in the Northern Hemisphere winter are considered (solar zenith angle ≥ 90°. We find that for moderately disturbed conditions, the foot of the polar cliff is located below 60° invariant latitude. Here, within about 4°, the density increases by a factor of 4, on average. The actual location of the polar cliff depends primarily on the level of geomagnetic activity, its associated density increase on geographic longitude and altitude. As to the longitudinal variations, they are attributed to asymmetries in the background ionization density at middle latitudes. Using a superposed epoch type of averaging procedure, mean latitudinal profiles of the polar cliff and the associated electron temperature changes are derived. Since these differ significantly from those derived for the afternoon/evening sector, we conclude that the subauroral ionospheric trough does not extend into the morning sector. As to the origin of the polar cliff in the morning sector, local auroral particle precipitation should play only a secondary role.

  18. Pharmacokinetics of Roflumilast and Its Active Metabolite Roflumilast N-Oxide in Healthy Chinese Subjects After Single and Multiple Oral Doses.

    Science.gov (United States)

    Li, Qian; Wang, Yiya; Liu, Lingye; Ma, Pengcheng; Ding, Li

    2017-06-01

    Roflumilast is a selective, oral phosphodiesterase 4 inhibitor approved for the treatment of severe chronic obstructive pulmonary disease. The aim of this study was to evaluate the pharmacokinetics of roflumilast and roflumilast N-oxide in healthy Chinese subjects, and the effects of gender and food on their respective pharmacokinetic profiles. 36 healthy Chinese subjects were recruited in a randomized, single-center, open-label, parallel group study and assigned to 0.25-, 0.375-, and 0.5-mg dose groups. The single-dose pharmacokinetic studies in fasting condition were carried out in all groups. Moreover, the food effect study and multiple-dose study were conducted in 0.375-mg dose group. Serial blood samples were collected over 168 h after dosing, and plasma concentrations of roflumilast and roflumilast N-oxide were determined using a validated LC-MS/MS method. After oral administration of single doses of 0.25, 0.375 and 0.5 mg of roflumilast under fasting condition, the mean AUC 0-72h for roflumilast was 21.7 ± 8.3, 29.8 ± 8.3 and 54.2 ± 21.3 ng·h/mL, respectively. Meanwhile the mean AUC 0-168h for roflumilast N-oxide was 290 ± 103, 385 ± 107 and 673 ± 245 ng·h/mL, respectively. In the steady state after the multi-dose administration, the exposure to roflumilast in the subjects increased 20-40 %, and the exposure to roflumilast N-oxide increased about 169 %, compared to the single-dose administration. No statistically significant effect of gender on the disposition of roflumilast and roflumilast N-oxide was observed. Food had no effect on systemic exposure to roflumilast and roflumilast N-oxide in the subjects, but delayed the T max of roflumilast by 0.9 h and reduced the C max of roflumilast by approximately 20 %. Based upon between-study comparison, peak and systemic exposure of roflumilast and roflumilast N-oxide were higher in Chinese than that in Caucasian subjects after oral administration of the same dose (i.e., 0.25 and 0.5

  19. Management of morning hypertension: a consensus statement of an Asian expert panel.

    Science.gov (United States)

    Wang, Ji-Guang; Kario, Kazuomi; Chen, Chen-Huan; Park, Jeong-Bae; Hoshide, Satoshi; Huo, Yong; Lee, Hae-Young; Li, Yan; Mogi, Masaki; Munakata, Masanori; Park, Sungha; Zhu, Dingliang

    2018-01-01

    Morning blood pressure (BP) surge is an important aspect of hypertension research. Morning BP monitoring could be a clinically relevant concept in the therapeutic management of hypertension and in the prevention of cardiovascular complications by defining and treating morning hypertension. Because antihypertensive medication is often taken in the morning, uncontrolled morning BP during the trough effect hours could be a hallmark of inadequate choice of antihypertensive regimen, such as the use of short- or intermediate-acting drugs, underdosing of drugs, or no use or underuse of combination therapy. To improve the management of hypertension in general and morning hypertension in particular, long-acting antihypertensive drugs should be used in appropriate, often full dosages and in proper combinations. The clinical usefulness of antihypertensive drugs with specific mechanisms for morning BP or split or timed dosing of long-acting drugs in controlling morning BP remains under investigation. ©2018 Wiley Periodicals, Inc.

  20. The Differential Hormonal Milieu of Morning versus Evening May Have an Impact on Muscle Hypertrophic Potential.

    Directory of Open Access Journals (Sweden)

    Simon D Burley

    Full Text Available Substantial gains in muscle strength and hypertrophy are clearly associated with the routine performance of resistance training. What is less evident is the optimal timing of the resistance training stimulus to elicit these significant functional and structural skeletal muscle changes. Therefore, this investigation determined the impact of a single bout of resistance training performed either in the morning or evening upon acute anabolic signalling (insulin-like growth factor-binding protein-3 (IGFBP-3, myogenic index and differentiation and catabolic processes (cortisol. Twenty-four male participants (age 21.4±1.9yrs, mass 83.7±13.7kg with no sustained resistance training experience were allocated to a resistance exercise group (REP. Sixteen of the 24 participants were randomly selected to perform an additional non-exercising control group (CP protocol. REP performed two bouts of resistance exercise (80% 1RM in the morning (AM: 0800 hrs and evening (PM: 1800 hrs, with the sessions separated by a minimum of 72 hours. Venous blood was collected immediately prior to, and 5 min after, each resistance exercise and control sessions. Serum cortisol and IGFBP-3 levels, myogenic index, myotube width, were determined at each sampling period. All data are reported as mean ± SEM, statistical significance was set at P≤0.05. As expected a significant reduction in evening cortisol concentration was observed at pre (AM: 98.4±10.5, PM: 49.8±4.4 ng/ml, P0.05. Timing of resistance training regimen in the evening appears to augment some markers of hypertrophic potential, with elevated IGFBP-3, suppressed cortisol and a superior cellular environment. Further investigation, to further elucidate the time course of peak anabolic signalling in morning vs evening training conditions, are timely.

  1. Therapeutic efficacy and toxicity of a single and double application of boron neutron capture therapy (BNCT) in a hamster cheek pouch oral precancer model

    International Nuclear Information System (INIS)

    Monti Hughes, A; Pozzi, E C C; Thorp, S; Garabalino, M A; Farias, R O; Gonzalez, S J; Heber, E M; Itoiz, M E; Aromando, R F; Molinari, A J; Miller, M; Nigg, D W; Curotto, P; Trivillin, V A; Schwint, A E

    2012-01-01

    Tumor development from tissue with potentially malignant disorders (PMD) gives rise to second primary tumors. We previously demonstrated the partial inhibitory effect on tumor development of Boron Neutron Capture Therapy (BNCT) mediated by the boron compounds BPA (boronophenylalanine) and decahydrodecaborate (GB-10) in a hamster pouch oral precancer model. Seeking to optimize BNCT, the aim of the present study was to contribute to the knowledge of BNCT radiobiology for oral precancer and assess new BNCT protocols in terms of inhibition of tumor development and radiotoxicity. Groups of cancerized hamsters were locally exposed to single or double applications (2 weeks apart) of BPA-BNCT or (GB-10 + BPA)-BNCT at a total dose of 8Gy to tissue with PMD; to a single application of BPA-BNCT at 6Gy and to a double application (4 weeks apart) of BPA-BNCT or (BPA + GB-10)-BNCT at a total dose of 10Gy. Cancerized, sham-irradiated hamsters served as controls. Clinical status, tumor development from tissue with PMD and mucositis were followed for 8 months. The marked therapeutic efficacy of single applications of BNCT at 6 and 8Gy were associated to severe radiotoxicity. Dose fractionation into 2 applications reduced mucositis but also reduced therapeutic efficacy, depending on dose and interval between applications. A double application (4 weeks apart) of (GB-10 + BPA)-BNCT at a total dose of 10Gy rendered the best therapeutic advantage, i.e. 63% - 100% inhibition of tumor development with only slight mucositis in 67% of cases. The data reported herein show that issues such as dose levels and dose fractionation, interval between applications, and choice of boron compounds are pivotal to therapeutic advantage and must be tailored for a particular pathology and anatomic site. The present study determined treatment conditions that would contribute to optimize BNCT for precancer and that would warrant cautious assessment in a clinical scenario (author)

  2. Influence of activated charcoal on the pharmacokinetics of moxifloxacin following intravenous and oral administration of a 400 mg single dose to healthy males

    Science.gov (United States)

    Stass, H; Kubitza, D; Möller, J-G; Delesen, H

    2005-01-01

    Aims To evaluate the extent to which enterohepatic recycling circulation contributes to moxifloxacin bioavailability in healthy, males by administration of activated charcoal and to evaluate the efficacy of activated charcoal administration in decreasing systemic concentrations of moxifloxacin in the event of overdose. Methods Nine healthy males, mean age 34 years (range 23–45 years) participated in a single centre, randomized, nonplacebo-controlled, three way crossover study. The pharmacokinetics of moxifloxacin in plasma and urine were determined for up to 96 h following a 400 mg single dose randomly administered on three separate occasions with a minimum washout phase of 1 week. Treatment A was 400 mg moxifloxacin IV as a 1 h infusion, treatment B was 400 mg moxifloxacin IV as a 1 h infusion with oral activated charcoal (5 g directly before the start of the infusion, 5 g immediately after the end of the infusion, and 10 g at 2, 4 and 8 h after the start of the infusion), treatment C was 400 mg oral moxifloxacin with activated charcoal (10 g 15 min before and at 2, 4 and 8 h after drug administration). The subjects underwent a series of clinical and laboratory tests. Results Single 400 mg doses of moxifloxacin (PO and/or IV) were safe and well tolerated. The bioavailability of moxifloxacin was significantly decreased when given with charcoal (AUC = 35.5 (IV reference) vs 5.40 (PO) vs 28.5 (IV) mg l−1 h). Concurrently peak concentrations were lowered Cmax = 3.38 (IV reference) vs 0.62(PO) vs 2.97 (IV) mg l−1) by approximately 85% (P activated charcoal may be useful in treating moxifloxacin overdose by preventing its absorption. PMID:15842551

  3. [Pharmacokinetics and relative bioavailability of THC and THC-solid dispersion orally to mice at single dose].

    Science.gov (United States)

    Liao, Li; Hua, Hua; Zhao, Jun-Ning; Luo, Heng; Yang, An-Dong

    2014-03-01

    To establish a fast sensitive, reproducible LC-MS/MS method to study pharmacokinetic properties of THC, and compare relative bioavailability of THC and its solid dispersion in mice. 200 mice were divided randomly into two groups, and administered orally with THC and THC-solid dispersion after fasting (calculate on THC:400 mg x kg(-1)), used HPLC-MS/MS method to determine the THC concentration of each period at the following times: baseline ( predose ), 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 24 h after dosing. Calculating the pharmacokinetic parameters according to the C-t curv, and then use the Phoenix WinNonlin software for data analysis. The calibration curves were linear over the range 9.06-972 microg x L(-1) for THC (R2 = 0.999). The limit of detection (LOD) was 0.7 microg x L(-1), respectively. The average extraction recoveries for THC was above 75%, The methodology recoveries were between 79% and 108%. The intra-day and inter-day RSD were less than 13%, the stability test showed that the plasma samples was stable under different conditions (RSD THC and THC-solid dispersion orally to mice shows as fllows: T(max), were 60 and 15 min, AUC(0-t) were 44 500.43 and 57 497.81 mg x L(-1) x min, AUC(0-infinity) were 51 226.00 and 68 031.48 mg x L(-1) x min, MRT(0-infinity) were 596.915 6, 661.747 7 min, CL(z)/F were 0.007 809 and 0.005 88 L x min(-1) x kg(-1). Compared with THC, the MRT and t1/2 of the THC-solid dispersion were all slightly extended, the t(max) was significantly reduced, AUC(0-24 h), AUC(0-infinity) and C(max) were all significantly higher, the relative bioavailability of THC-solid dispersion is 1.34 times of THC. The results of the experiment shows that the precision, accuracy, recovery and applicability were found to be adequate for the pharmacokinetic studies. After oral administration to mice, the relative bioavailability of THC-solid dispersion show significant improvement compared to THC.

  4. Association of Morning Hypertension Subtype With Vascular Target Organ Damage and Central Hemodynamics.

    Science.gov (United States)

    Oh, Jaewon; Lee, Chan Joo; Kim, In-Cheol; Lee, Sang-Hak; Kang, Seok-Min; Choi, Donghoon; Park, Sungha; Kario, Kazuomi

    2017-02-14

    A recent study reported that morning hypertension is associated with poor cardiovascular outcomes in hypertensive patients. However, it is unclear whether morning hypertension associated with sustained nocturnal hypertension and that associated with morning blood pressure (BP) surge differ in terms of their effects on cardiovascular target organ damage and clinical outcomes. The present study aimed to determine the association of morning hypertension with/without nocturnal hypertension with vascular target organ damage and central hemodynamics in patients at high risk for cardiovascular disease. Ambulatory BP monitoring was performed and central BP was measured in 1070 consecutive patients with high cardiovascular risk. We grouped morning hypertension into the following 3 subtypes: (I) morning normotension; (II) morning hypertension without nocturnal hypertension; and (III) morning hypertension with nocturnal hypertension. Morning hypertension was noted in 469 (43.8%) patients and morning hypertension with nocturnal hypertension was noted in 374 (34.9%) patients. The central systolic/diastolic BP and carotid to femoral pulse wave velocity were significantly higher in the subtype III group than in the subtype I and II groups (all P Morning hypertension, especially that associated with nocturnal hypertension, is related to high central BP and increased arterial stiffness. Further studies on whether morning hypertension with or without nocturnal hypertension is related to clinical outcomes should be performed. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02003781. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  5. Metabolism and elimination of methyl, iso- and n-butyl paraben in human urine after single oral dosage.

    Science.gov (United States)

    Moos, Rebecca K; Angerer, Jürgen; Dierkes, Georg; Brüning, Thomas; Koch, Holger M

    2016-11-01

    Parabens are used as preservatives in personal care and consumer products, food and pharmaceuticals. Their use is controversial because of possible endocrine disrupting properties. In this study, we investigated metabolism and urinary excretion of methyl paraben (MeP), iso-butyl paraben (iso-BuP) and n-butyl paraben (n-BuP) after oral dosage of deuterium-labeled analogs (10 mg). Each volunteer received one dosage per investigated paraben separately and at least 2 weeks apart. Consecutive urine samples were collected over 48 h. In addition to the parent parabens (free and conjugated) which are already used as biomarkers of internal exposure and the known but non-specific metabolites, p-hydroxybenzoic acid (PHBA) and p-hydroxyhippuric acid (PHHA), we identified new, oxidized metabolites with hydroxy groups on the alkyl side chain (3OH-n-BuP and 2OH-iso-BuP) and species with oxidative modifications on the aromatic ring. MeP represented 17.4 % of the dose excreted in urine, while iso-BuP represented only 6.8 % and n-BuP 5.6 %. Additionally, for iso-BuP, about 16 % was excreted as 2OH-iso-BuP and for n-BuP about 6 % as 3OH-n-BuP. Less than 1 % was excreted as ring-hydroxylated metabolites. In all cases, PHHA was identified as the major but non-specific metabolite (57.2-63.8 %). PHBA represented 3.0-7.2 %. For all parabens, the majority of the oral dose captured by the above metabolites was excreted in the first 24 h (80.5-85.3 %). Complementary to the parent parabens excreted in urine, alkyl-chain-oxidized metabolites of the butyl parabens are introduced as valuable and contamination-free biomarkers of exposure.

  6. Pharmacokinetics of Levetiracetam in Healthy Hispaniolan Amazon Parrots ( Amazona ventralis ) After Oral Administration of a Single Dose.

    Science.gov (United States)

    Schnellbacher, Rodney; Beaufrère, Hugues; Vet, Dr Med; Arnold, Robert D; Tully, Thomas N; Mayer, Joerg; Divers, Stephen J

    2014-09-01

    Long-term anticonvulsive treatments have been poorly described in birds, and few pharmacokinetic studies have been performed, with mixed results. Levetiracetam, a new anticonvulsive drug, has shown good efficacy for monotherapy or adjunctive treatment of seizures in both human and veterinary medicine. To determine pharmacokinetics of levetiracetam in Hispaniolan Amazon parrots ( Amazona ventralis ), 20 healthy birds were randomly divided into 2 groups and administered either a 50 mg/kg (n = 10) or a 100 mg/kg (n = 10) oral dose of levetiracetam with no observable adverse effects. Blood samples were collected at baseline and at 12 time intervals (6 per group) for 16 hours. The concentration-time profiles resembled characteristic absorption, with maximum plasma concentrations of 61.0 μg/mL and 95.1 μg/mL at 60 minutes; terminal half-lives at 2.38 and 2.37 hours; volumes of distribution of 0.807 and 0.773 L/kg, with an area under the curve at 14 100 and 28 820 mg × min/L; and clearance rates of 3.65 and 3.60 mL/min per kg, respectively. Plasma concentrations were greater than 5.5 mg/L for up to 9.4 and 12 hours, suggesting an 8- and 12-hour oral dosing at 50 and 100 mg/kg, respectively, would be sufficient to maintain targeted values. Clinically, doses and frequencies may need escalation based on differences in species and individuals, and drug levels should be monitored.

  7. Significance of higher drug concentration in erythrocytes of mice infected with Schistosoma japonicum and treated orally with mefloquine at single doses.

    Science.gov (United States)

    Tao, Yi; Xue, Jian; Jiang, Bin; Zhang, Hao-Bing; Xiao, Shu-Hua

    2015-12-01

    The purpose of the present study is to understand the pharmacokinetic feature of mefloquine measured by erythrocytes and plasma in Schistosoma japonicum (S. j.)-infected mice and non-infected mice after oral administration of the drug at single doses. A high-performance liquid chromatography (HPLC) method was used to measure the plasma and erythrocyte concentrations of mefloquine at varying intervals posttreatment. Our results demonstrated that in non-infected mice treated orally with mefloquine at an ineffective dose of 50 mg/kg or effective dose of 200 mg/kg for 2-72 h, the erythrocyte-to-plasma ratios of mefloquine were 5.8-11.2 or 2-14.2. On the other hand, in S. j.-infected mice treated with the same single doses of the drug, the erythrocyte and plasma drug concentration ratios were 3.1-4.6 or 2.9-8.5, manifesting that either in infected mice or in non-infected mice that received oral mefloquine resulted in higher concentration of mefloquine in erythrocytes than that in plasma. Unexpectedly, under oral administration of mefloquine at a higher single dose of 200 mg/kg, the pharmacokinetic parameter C max values for plasma from S. j.-infected and non-infected mice were 1.6 ± 0.3 and 2.0 ± 0.4 μg/mL, respectively, which were below the determined in vitro LC50 (50 % lethal concentration) value of 4.93 μg/mL. Therefore, the plasma concentration of mefloquine may display a little effect against schistosomes during the treatment. Although the values of T 1/2 and AUC0-∞ for erythrocytes were significantly longer and higher in infected mice than those of corresponding non-infect mice that received the same single mefloqine dose of 50 mg/kg, the C max value was only 2.6 ± 0.4 μg/mL lower than the determined in vitro LC50, which may explain why this low single dose is ineffective against schistosomes in vivo. After administration of higher mefloquine dose of 200 mg/kg, the C max value for erythrocytes in infected mice was 30 % (7.4 ± 0

  8. [Acupuncture combined with medication for morning blood pressure of essential hypertension].

    Science.gov (United States)

    Zhang, Yi; Du, Yuzheng

    2018-04-12

    Based on the western medication, to evaluate the advantages in the morning blood pressure treated with acupuncture at Fengchi (GB 20) and Neck-Jiaji (EX-B 2) combined with acupuncture technique for activating blood circulation, eliminating wind and regulating the liver and spleen in the patients with essential hypertension. A total of 90 patients of essential hypertension of the mild and moderate degrees were randomized into a medication group (30 cases, 3 dropping), No.1 acupuncture group (30 cases, 2 dropping) and No.2 acupuncture group (30 cases, 1 dropping). In the medication group, adalat was prescribed for oral administration, 30 mg at 7 am every day, continuously for 6 weeks. In the No.1 acupuncture group, on the basis of the treatment as the medication group, the acupuncture technique for activating blood circulation, eliminating wind and regulating the liver and spleen was applied and the acupoints were Renying (ST 9), Hegu (LI 4), Taichong (LR 3), Quchi (LI 11) and Zusanli (ST 36). In the No.2 acupuncture group, on the basis of the treatment as the No.1 acupuncture group, Fengchi (GB 20) and Neck-Jiaji (EX-B 2) were added in acupuncture. Acupuncture was given in the time zone from 8 am through 10 am every day, once a day, 5 times a week, totally for 6 weeks. Separately, before treatment and in 2, 4 and 6 weeks of treatment, the morning blood pressure, the control rate and the symptom score were observed in the patients of the three groups. The morning blood pressure was followed up in 3 and 6 months separately. Compared with those before treatment, in 2, 4 and 6 weeks of treatment, the levels of blood pressure reduced in the patients of the three groups ( P 0.05). In 4 and 6 weeks of treatment, the levels of the morning blood pressure in the No.2 acupuncture group were lower than those in the No.1 acupuncture group, and the results in the No.1 and No.2 acupuncture groups were all lower than those in the medication group (all P 0.05). In 2, 4 and 6 weeks

  9. Pharmacokinetic Properties and Tolerability of Cycloserine Following Oral Administration in Healthy Chinese Volunteers: A Randomized, Open-Label, Single- and Multiple-Dose 3-Way Crossover Study.

    Science.gov (United States)

    Zhou, Huili; Wu, Guolan; Hu, Xingjiang; Zhu, Meixiang; Zhai, You; Liu, Jian; Shentu, Jianzhong; Wu, Lihua

    2015-06-01

    A new generic formulation of cycloserine has been developed in China but the pharmacokinetic properties of cycloserine in the Chinese population have not been reported. The aim of our study was to evaluate the pharmacokinetic properties and tolerability of single and multiple oral administrations of cycloserine capsules in healthy Chinese volunteers. This open-label, single- and multiple-dose 3-way crossover study was conducted in healthy Chinese volunteers. Subjects were randomized to receive a single dose of cycloserine (250, 500, or 1000 mg) in separate trial periods, with a 1-week washout between periods. Those allocated to the 250-mg dose continued into the multiple-dose phase, in which they received 250 mg BID for 5 consecutive days. During the single-dose phase, blood samples were collected at regular intervals from 0 to 72 hours after drug administration and the concentrations of cycloserine were determined using LC-MS/MS. During the multiple-dose phase, blood samples were obtained before drug administration on Days 4, 5, and 6 to determine the Cmin at steady state. On Day 6, blood samples were also collected from 0 to 72 hours after drug administration. Pharmacokinetic parameters were estimated using noncompartmental methods. Tolerability was determined using clinical evaluation and monitoring of adverse events. The study enrolled 12 healthy Chinese volunteers (6 men: mean [SD] age = 23.0 [2.6] years, weight = 60.2 [6.2] kg, height = 170.0 [3.0] cm, and body mass index = 20.7 [1.7]; 6 women: mean [SD] age = 25.3 [1.4] years, weight = 51.5 [3.3] kg, height = 160.0 [4.0] cm, and body mass index = 20.1 [0.9]). After administration of a single dose, cycloserine was rapidly absorbed, reaching peak plasma concentrations approximately 0.84 hours after oral administration, and t½ in plasma was about 13.0 hours. The geometric mean (SD) Cmax value increased in proportion to cycloserine dose, from 19.42 (5.89) to 84.76 (21.74) mg/L, and the geometric mean (SD) AUC0

  10. Preclinical Study of Single-Dose Moxidectin, a New Oral Treatment for Scabies: Efficacy, Safety, and Pharmacokinetics Compared to Two-Dose Ivermectin in a Porcine Model.

    Science.gov (United States)

    Bernigaud, Charlotte; Fang, Fang; Fischer, Katja; Lespine, Anne; Aho, Ludwig Serge; Dreau, Dominique; Kelly, Andrew; Sutra, Jean-François; Moreau, Francis; Lilin, Thomas; Botterel, Françoise; Guillot, Jacques; Chosidow, Olivier

    2016-10-01

    Scabies is one of the commonest dermatological conditions globally; however it is a largely underexplored and truly neglected infectious disease. Foremost, improvement in the management of this public health burden is imperative. Current treatments with topical agents and/or oral ivermectin (IVM) are insufficient and drug resistance is emerging. Moxidectin (MOX), with more advantageous pharmacological profiles may be a promising alternative. Using a porcine scabies model, 12 pigs were randomly assigned to receive orally either MOX (0.3 mg/kg once), IVM (0.2 mg/kg twice) or no treatment. We evaluated treatment efficacies by assessing mite count, clinical lesions, pruritus and ELISA-determined anti-S. scabiei IgG antibodies reductions. Plasma and skin pharmacokinetic profiles were determined. At day 14 post-treatment, all four MOX-treated but only two IVM-treated pigs were mite-free. MOX efficacy was 100% and remained unchanged until study-end (D47), compared to 62% (range 26-100%) for IVM, with one IVM-treated pig remaining infected until D47. Clinical scabies lesions, pruritus and anti-S. scabiei IgG antibodies had completely disappeared in all MOX-treated but only 75% of IVM-treated pigs. MOX persisted ~9 times longer than IVM in plasma and skin, thereby covering the mite's entire life cycle and enabling long-lasting efficacy. Our data demonstrate that oral single-dose MOX was more effective than two consecutive IVM-doses, supporting MOX as potential therapeutic approach for scabies.

  11. Preclinical Study of Single-Dose Moxidectin, a New Oral Treatment for Scabies: Efficacy, Safety, and Pharmacokinetics Compared to Two-Dose Ivermectin in a Porcine Model

    Science.gov (United States)

    Bernigaud, Charlotte; Aho, Ludwig Serge; Dreau, Dominique; Kelly, Andrew; Sutra, Jean-François; Moreau, Francis; Lilin, Thomas; Botterel, Françoise; Guillot, Jacques; Chosidow, Olivier

    2016-01-01

    Background Scabies is one of the commonest dermatological conditions globally; however it is a largely underexplored and truly neglected infectious disease. Foremost, improvement in the management of this public health burden is imperative. Current treatments with topical agents and/or oral ivermectin (IVM) are insufficient and drug resistance is emerging. Moxidectin (MOX), with more advantageous pharmacological profiles may be a promising alternative. Methodology/Principal Findings Using a porcine scabies model, 12 pigs were randomly assigned to receive orally either MOX (0.3 mg/kg once), IVM (0.2 mg/kg twice) or no treatment. We evaluated treatment efficacies by assessing mite count, clinical lesions, pruritus and ELISA-determined anti-S. scabiei IgG antibodies reductions. Plasma and skin pharmacokinetic profiles were determined. At day 14 post-treatment, all four MOX-treated but only two IVM-treated pigs were mite-free. MOX efficacy was 100% and remained unchanged until study-end (D47), compared to 62% (range 26–100%) for IVM, with one IVM-treated pig remaining infected until D47. Clinical scabies lesions, pruritus and anti-S. scabiei IgG antibodies had completely disappeared in all MOX-treated but only 75% of IVM-treated pigs. MOX persisted ~9 times longer than IVM in plasma and skin, thereby covering the mite’s entire life cycle and enabling long-lasting efficacy. Conclusions/Significance Our data demonstrate that oral single-dose MOX was more effective than two consecutive IVM-doses, supporting MOX as potential therapeutic approach for scabies. PMID:27732588

  12. Safety of intramuscular influenza vaccine in patients receiving oral anticoagulation therapy: a single blinded multi-centre randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Benítez Mència

    2008-05-01

    Full Text Available Abstract Background Influenza vaccines are recommended for administration by the intramuscular route. However, many physicians use the subcutaneous route for patients receiving an oral anticoagulant because this route is thought to induce fewer hemorrhagic side effects. Our aim is to assess the safety of intramuscular administration of influenza vaccine in patients on oral anticoagulation therapy. Methods Design: Randomised, controlled, single blinded, multi-centre clinical trial. Setting: 4 primary care practices in Barcelona, Spain. Participants: 229 patients on oral anticoagulation therapy eligible for influenza vaccine during the 2003–2004 season. Interventions: intramuscular administration of influenza vaccine in the experimental group (129 patients compared to subcutaneous administration in the control group (100 patients. Primary outcome: change in the circumference of the arm at the site of injection at 24 hours. Secondary outcomes: appearance of local reactions and pain at 24 hours and at 10 days; change in INR (International Normalized Ratio at 24 hours and at 10 days. Analysis was by intention to treat using the 95% confidence intervals of the proportions or mean differences. Results Baseline variables in the two groups were similar. No major side effects or major haemorrhage during the follow-up period were reported. No significant differences were observed in the primary outcome between the two groups. The appearance of local adverse reactions was more frequent in the subcutaneous administration group (37,4% vs. 17,4%, 95% confidence interval of the difference 8,2% to 31,8%. Conclusion This study shows that the intramuscular administration route of influenza vaccine in patients on anticoagulant therapy does not have more side effects than the subcutaneous administration route. Registration number NCT00137579 at clinicaltrials.gov

  13. Oral health related quality-of-life outcomes of partially edentulous patients treated with implant-supported single crowns or fixed partial dentures.

    Science.gov (United States)

    AlZarea, Bader K

    2017-05-01

    Oral health-related quality of life (OHRQoL) is afflicted by different variables. Limited information is available regarding the impact of different phases of implant therapy on OHRQoL of edentulous patients. This study was carried out to assess the OHRQoL of patients treated with implant-supported single crowns or fixed partial dentures. A total of 79 healthy partially edentulous subjects needing implant therapy were incorporated in this study. Before placement of the implants, the subjects were instructed to fill the original version of OHIP questionnaire. Subsequently patients received titanium oral implants of the ITI® Dental Implant System. After 1st, 2nd and 3rd year of implant placement, patients filled the same OHIP-49 questionnaire. In this manner the impact of implant therapy on OHRQoL by putting in comparison pre- and post-treatment OHIP-49 scores was assessed. Statistical analyses were performed using Statistical Package for the Social Science software (SPSS, version 22, Chicago, IL, USA). Paired t test and Unpaired t test were performed and a statistical significance was set at 5% level of significance ( p disability, psychological disability, social disability were significantly decreased from baseline to 1st year ( p 0.05). All variables were also significantly decreased from baseline to 2nd year and 3rd year ( p 0.05). Patients aged less than 60 years and more than 60 years of age groups differed significantly with respect to OHIP scores measured at 1st year, 2nd year and at 3rd year of implant placement ( p Oral health-related quality-of-life.

  14. Immunogenicity and protection from a single dose of internationally available killed oral cholera vaccine: a systematic review and meta-analysis.

    Science.gov (United States)

    Lopez, Anna Lena; Deen, Jacqueline; Azman, Andrew S; Luquero, Francisco J; Kanungo, Suman; Dutta, Shanta; von Seidlein, Lorenz; Sack, David A

    2017-11-21

    In addition to improved water supply and sanitation, the two-dose killed oral cholera vaccine (OCV) is an important tool for the prevention and control of cholera. We aimed to document the immunogenicity and protection (efficacy and effectiveness) conferred by a single OCV dose against cholera. The meta-analysis showed an estimated 73% and 77% of individuals seroconverted to the Ogawa and Inaba serotypes, respectively, after an OCV first dose. The estimates of single-dose vaccine protection from available studies are 87% at 2 months decreasing to 33% at 2 years. Current immunologic and clinical data suggest that protection conferred by a single dose of killed OCV may be sufficient to reduce short-term risk in outbreaks or other high-risk settings, which may be especially useful when vaccine supply is limited. However, until more data suggests otherwise, a second dose should be given as soon as circumstances allow to ensure robust protection. © The Author(s) 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

  15. Toxicokinetics of bisphenol A in female DA/Han rats after a single i.v. and oral administration.

    Science.gov (United States)

    Upmeier, A; Degen, G H; Diel, P; Michna, H; Bolt, H M

    2000-10-01

    Bisphenol A [BPA; 2,2-bis-(4-hydroxyphenyl)-propane] is a monomer used in the manufacture of resins with a wide range of applications, e.g. plastic coatings in the food packaging industry. BPA has been shown to have a weak oestrogenic activity in vitro and in vivo. Despite its low oestrogenic potency there is concern that, as a consequence of slow clearance, BPA might reach biologically significant levels in humans and animals exposed to environmental levels. To address this concern, we assessed the kinetic behaviour of BPA in female DA/Han rats. Groups of female rats received 10 mg BPA/kg body weight intravenously or 10 or 100 mg BPA/kg body weight orally (by gavage). Blood samples were collected at different time-points and plasma was prepared. Free BPA in the samples was isolated by fluid-fluid extraction. BPA was measured by GC-MS which allowed the reliable determination of BPA concentrations as low as approximately 10 ng/ml plasma. Immediately after i.v. administration, the BPA plasma concentration was in the range of about 15 microg/ml and decreased rapidly within the first hour (to 700 ng/ml). The levels declined further (100 ng/ml at 2 h), and after 24 h the analytical detection limit was reached. BPA was detected in plasma as early as 10 min after gavage administration, indicating rapid initial uptake from the gastrointestinal tract. Absorption of BPA was variable. In animals receiving 10 mg/kg, maximal plasma levels were reached after 1.5 h (31 ng/ ml) and 6 h (40 ng/ml). In animals receiving 100 mg/kg, plasma levels reached maxima around 30 min (150 ng/ml) and 3 h (134 ng/ml) after administration. After 48 h BPA was at or below the detection limit in both dose groups. Fluctuations in the BPA plasma concentrations over time point to the possibility of enterohepatic recirculation and protracted absorption from the gastrointestinal tract. Using the area under the concentration-time curves (AUCs), low bioavailabilities of 16.4% and 5.6% were calculated for

  16. Double-blind parallel comparison of single oral doses of ketoprofen, codeine, and placebo in patients with moderate to severe dental pain.

    Science.gov (United States)

    Mehlisch, D; Frakes, L; Cavaliere, M B; Gelman, M

    1984-01-01

    Ketoprofen, 25, 50, and 100 mg, was compared with 90 mg codeine and placebo for relief of pain due to removal of impacted third molar teeth. Treatment was self-administered as a single oral dose under double-blind conditions in five parallel groups established by a random code in healthy young adults. Based on 129 patient evaluations of pain experience and pain relief, ketoprofen was shown to have a more rapid onset and longer duration of action than codeine. In the derived variables of SPID (Sum of Pain Intensity Differences) and TOPAR (Total Pain Relief), all three doses of ketoprofen, with no dose-related differences among them, were found to provide statistically superior analgesia to codeine and placebo. All five treatments were associated with some adverse reactions.

  17. Data describing the flow-mediated vasodilation responses and blood pressure in young adult humans after a single dose of oral edible emu oil

    Directory of Open Access Journals (Sweden)

    Tadayoshi Miyashita

    2018-04-01

    Full Text Available The data provided herein include flow-mediated vasodilation responses, represented by changes in arterial diameter, and blood pressure in young adults after a single oral dose of edible emu oil or placebo (cross-over design. Ten healthy men and 10 healthy women participated. Increased blood flow in the antebrachial region was induced by inflating a pressure cuff and subsequently releasing the pressure by deflating the cuff. After the release, the arterial diameter was continuously monitored for 110 sec using ultrasonic diagnostic equipment. The changes in the arterial diameter from 20 to 110 sec post-cuff deflation are described in line graphs and tables. In addition, systolic and diastolic blood pressure data are provided in a table.

  18. New timetable for a Regular morning and evening shuttle

    CERN Multimedia

    TS Department

    2008-01-01

    Starting from 31 March 2008, for one month, a new timetable for a regular morning and evening shuttle serving LHC Points 2 and 5 will be put in place. You can find all the corresponding details on the FM group WEB page: http://ts-dep.web.cern.ch/ts-dep/groups/fm/logistique/shuttle_timetable.htm Please note that during April, all other requests for transport from Meyrin and Prévessin to the LHC Points via tel. 76969 during the day (between 8:30 and 17:30) will not be met. TS/FM group Tel. 160239

  19. New timetable for a morning and evening regular shuttle

    CERN Multimedia

    TS Department

    2008-01-01

    Starting from the 31st of March 2008 and for one month, a new timetable for a morning and evening regular shuttle serving LHC Points 2 and 5, will be put in place. You can find all the corresponding details in the FM group WEB page http://ts-dep.web.cern.ch/ts-dep/groups/fm/logistique/shuttle_timetable.htm Please note that during April, every other request of transfer from Meyrin and Prevessin towards LHC Points reaching the 76969 during the day (between 8:30 and 17:30) will not be satisfied. TS/FM group 160239

  20. Evaluation of Sphingolipids in Wistar Rats Treated to Prolonged and Single Oral Doses of Fumonisin B1

    Science.gov (United States)

    Direito, Glória M.; Almeida, Adriana P.; Aquino, Simone; dos Reis, Tatiana Alves; Pozzi, Claudia Rodrigues; Corrêa, Benedito

    2009-01-01

    The objective of the present study was to evaluate sphingolipid levels (sphingosine-So and sphinganine-Sa) and to compare the Sa/So ratio in liver, serum and urine of Wistar rats after prolonged administration (21 days) of fumonisin B1 (FB1). In parallel, the kinetics of sphingolipid elimination in urine was studied in animals receiving a single dose of FB1. Prolonged exposure to FB1 caused an increase in Sa levels in urine, serum and liver. The most marked effect on sphingolipid biosynthesis was observed in animals treated with the highest dose of FB1. Animals receiving a single dose of FB1 presented variations in Sa and So levels and in the Sa/So ratio. PMID:19333435

  1. Pharmacokinetics of single-dose sildenafil administered orally in clinically healthy dogs: Effect of feeding and dose proportionality.

    Science.gov (United States)

    Akabane, R; Sato, T; Sakatani, A; Miyagawa, Y; Tazaki, H; Takemura, N

    2018-01-19

    Basic information related to the pharmacokinetics of sildenafil in dogs is scarce. This study aimed to describe the pharmacokinetic properties of oral sildenafil and determine the effect of feeding and dose proportionality. The effect of feeding on pharmacokinetics of sildenafil (1 mg/kg) was investigated using a crossover study with six dogs. In addition, the dose proportionality of sildenafil ranging 1-4 mg/kg was evaluated using five dogs in the fasted states. The plasma concentrations of sildenafil were determined using high-performance liquid chromatography, and pharmacokinetic parameters were calculated using a noncompartmental analysis. Sildenafil administrations were well tolerated in all studies. Feeding reduced the area under the curve extrapolated to infinity (AUC inf ) and the maximum plasma concentration (C max ) significantly. The elimination half-life (T 1/2 ) did not differ between the fasted and the fed states. For dose proportionality, nonproportional increases in AUC inf and C max at 1-4 mg/kg doses were detected by a power model analysis. © 2018 John Wiley & Sons Ltd.

  2. Acute effects of a single, oral dose of d9-tetrahydrocannabinol (THC) and cannabidiol (CBD) administration in healthy volunteers.

    Science.gov (United States)

    Martin-Santos, R; Crippa, J A; Batalla, A; Bhattacharyya, S; Atakan, Z; Borgwardt, S; Allen, P; Seal, M; Langohr, K; Farré, M; Zuardi, A W; McGuire, P K

    2012-01-01

    Animal and humans studies suggest that the two main constituents of cannabis sativa, delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) have quite different acute effects. However, to date the two compounds have largely been studied separately. To evaluate and compare the acute pharmacological effects of both THC and CBD in the same human volunteers. A randomised, double-blind, cross-over, placebo controlled trial was conducted in 16 healthy male subjects. Oral THC 10 mg or CBD 600 mg or placebo was administered in three consecutive sessions, at one-month interval. Physiological measures and symptom ratings were assessed before, and at 1, 2 and 3 hours post drug administration. The area under the curve (AUC) between baseline and 3 hours, and the maximum absolute change from baseline at 2 hours were analysed by one-way repeated measures analysis of variance, with drug condition (THC or CBD or placebo) as the factor. Relative to both placebo and CBD, administration of THC was associated with anxiety, dysphoria, positive psychotic symptoms, physical and mental sedation, subjective intoxication (AUC and effect at 2 hours: p CBD and placebo on any symptomatic, physiological variable. In healthy volunteers, THC has marked acute behavioural and physiological effects, whereas CBD has proven to be safe and well tolerated.

  3. Oral Health

    Science.gov (United States)

    ... section Home A-Z Health Topics Oral health Oral health > A-Z Health Topics Oral health (PDF, 154 ... To receive Publications email updates Enter email Submit Oral health Women have unique oral health concerns. Changing hormone ...

  4. Reliability and Validity of the Daily Parent Rating of Evening and Morning Behavior Scale, Revised.

    Science.gov (United States)

    Faraone, Stephen V; Childress, Ann; Wigal, Sharon B; Kollins, Scott H; McDonnell, Mary Ann; DeSousa, Norberto J; Sallee, F Randy

    2015-12-23

    Children with ADHD frequently manifest behavioral difficulties in the morning prior to school. We sought to assess the reliability and validity of the Daily Parent Rating of Evening and Morning Behavior Scale, Revised (DPREMB-R) morning score as a measure of morning behaviors impaired by ADHD. We used data from a clinical trial of HLD200 treatment in pediatric participants with ADHD to address our objectives. The DPREMB-R morning score showed significant internal homogeneity, test-retest reliability (r = .52-.45), and good concurrent validity (r = .50-.71). The DPREMB-R morning score could be a useful instrument for assessing treatment efficacy in the morning before school. © The Author(s) 2015.

  5. Pharmacokinetics of tedizolid following oral administration: single and multiple dose, effect of food, and comparison of two solid forms of the prodrug.

    Science.gov (United States)

    Flanagan, Shawn D; Bien, Paul A; Muñoz, Kelly A; Minassian, Sonia L; Prokocimer, Philippe G

    2014-03-01

    The single- and multiple-dose pharmacokinetics (PK) of tedizolid were examined after oral administration of tedizolid phosphate disodium (TPD), including the effect of food on PK. The relative bioavailability of TPD to the free acid tedizolid phosphate was determined to bridge the results of these and other studies to the solid form of the prodrug selected for further development. Randomized placebo-controlled, double-blind single- and multiple-ascending dose studies and randomized open-label, crossover food effect and relative bioavailability studies. Clinical Research Units. Healthy subjects. Study TR701-101 enrolled 40 subjects in single-ascending dose (200-1200 mg TPD or placebo) and 40 subjects in 21-day multiple-ascending dose (200, 300, or 400 mg TPD once/day; 600 mg linezolid twice/day; or placebo) arms. Study TR701-103 was a food-effect study in 12 subjects administered 600 mg TPD. Study TR701-108 was a relative bioavailability study in 12 subjects administered 150-mg tedizolid equivalents as TPD or tedizolid phosphate. Plasma concentrations of the prodrug tedizolid phosphate, its active moiety tedizolid, and/or linezolid were collected. After administration of 200 to 600 mg TPD, tedizolid values increased approximately dose proportionally in area under the concentration-time curve (AUC) and maximum plasma concentration (Cmax ). Tedizolid half-life values were approximately 2-fold greater compared with linezolid. TPD administration with food delayed tedizolid absorption and reduced Cmax relative to the fasted state but did not alter AUC. Minimal accumulation was predicted and observed for tedizolid, whereas observed accumulation of linezolid exceeded predictions based on single-dose PK. Comparable PK of tedizolid was observed following oral administration of either TPD or tedizolid phosphate. In the multiple-ascending dose study, 3 of 24 tedizolid subjects were withdrawn under prespecified stopping rules (one each of elevated alanine

  6. Treatment of pneumonia in infants with daily single oral dose of cefixime Tratamiento de la neumonía del lactante con cefixima en dosis única diaria

    Directory of Open Access Journals (Sweden)

    Rafael J. Manotas Cabarcas

    1997-01-01

    Full Text Available Treatment of pneumonia in infants with dail y single oral dose of cefixime Twenty five male and female Infants aged two to twenty-three months suffering from bacterial pneumonia were treated with cefixime in order to evaluate clinical efficiency and tolerance. A daily single oral dose of 8 mg kg was given for fourteen days. Clinical status and radiologic and laboratory findings improved during the course of therapy. A case of gastrointestinal intolerance (4% and twelve (48% of high levels of transaminases were observed. In 6 cases (24% the ethiologic agent was found. No significant differences were detected in clinical or paraclinical behavior between the groups of known and unknown ethiology. Therapy was quite successful in 96% of the C8ses. Hepatic effects of cefixime ought to be further Investigated. Para evaluar la eficacia clínica y la tolerancia a la Cefixima, se trató con ella un grupo de 25 niños y niñas lactantes de 2 a 23 meses de edad, que padecían neumonías bacterianas. Se usó una dosis de 8 mg/kg/día, por vía oral, durante catorce días y en una sola toma. Los signos clínicos evaluados, los hallazgos radiológicos y los de laboratorio mejoraron en el transcurso de la terapia. Se presentaron un caso (4% de intolerancia gastrointestinal y doce (48% con aumento de las transaminasas. En el 24% se encontró el agente causal. No se detectó una diferencia significativa en el comportamiento clínico y paraclínico de los niños con neumonía de etiología conocida en comparación con aquéllos en que no se la definió. Se obtuvo un 96% de resultados muy buenos en la terapia. Se debe investigar más el efecto del medicamento sobre la función hepática.

  7. [Safety Evaluation of Rare Sugar Syrup: Single-dose Oral Toxicity in Rats, Reverse Mutation Assay, Chromosome Aberration Assay, and Acute Non-Effect Level for Diarrhea of a Single Dose in Humans].

    Science.gov (United States)

    Yamada, Takako; Iida, Tetsuo; Takamine, Satoshi; Hayashi, Noriko; Okuma, Kazuhiro

    2015-01-01

    The safety of rare sugar syrup obtained from high-fructose corn syrup under slightly alkaline conditions was studied. Mutagenicity of rare sugar syrup was assessed by a reverse mutation assay using Salmonella typhimurium and Escherichia coli, and an in vitro chromosomal aberration assay using Chinese hamster lung cell line (CHL/IU). No mutagenicity of rare sugar syrup was detected under these experimental conditions. Oral administration of single dose (15,000 mg/kg) of rare sugar syrup to rats caused no abnormalities, suggesting no adverse effect of rare sugar syrup. In humans, the acute non-effect level of rare sugar syrup for causing diarrhea was estimated as 0.9 g/kg body weight as dry solid base in both males and females.

  8. A review of oral food challenges in children presenting to a single tertiary centre with perceived or true food allergies.

    Science.gov (United States)

    Thalayasingam, Meera; Loo, Evelyn Xiu Ling; Tan, Michelle Meiling; Bever, Hugo Van; Shek, Lynette Pei-Chi

    2015-11-01

    The prevalence of perceived food allergies exceeds that of true food allergies. Unnecessary food avoidance may increase parental and patient anxiety, reduce quality of life and increase the risk of nutritional deficiency. An oral food challenge (OFC) can provide an objective measure regarding the presence or absence of food allergies in a child. This study reviews the indications for and outcomes of OFCs performed on children. A retrospective review was performed on all children who underwent OFCs at the Allergy Unit of the National University Hospital, Singapore, over a three-year period. A total of 197 OFCs were performed among 58 patients (34 male, 24 female). Most of the tests were for allergies to tree nuts (n = 107). Among the OFCs, 43.1% were for foods that were avoided and never eaten due to perceived food allergies, 25.9% were for foods that had previously resulted in positive skin prick tests (SPTs) and/or immunoassay results, 16.2% were for foods thought to worsen eczema and 14.7% were for foods thought to have caused a previous reaction. Of all the OFCs, 5% were positive, although adverse reactions were mostly cutaneous. Challenge-positive patients had either positive SPTs (wheal > 3 mm) or raised serum immunoglobulin E levels to specific foods that they reacted to during the challenges. No episodes of anaphylaxis were reported after the challenge. Most of the patients were able to safely introduce the avoided foods into their diets. OFCs provide an objective assessment for suspected food allergies.

  9. Serum and Urine Concentrations of Flunitrazepam and Metabolites, after a Single Oral Dose, by Immunoassay and GC-MS

    OpenAIRE

    Snyder, H.; Schwenzer, K.S.; Pearlman, R.; McNally, A.J.; Tsilimidos, M.; Salamone, S.J.; Brenneisen, R.; ElSohly, M.A.; Feng, S.; Brenneisen, R.

    2017-01-01

    A clinical study was conducted to assess the ability of commercially available immunoassays to detect flunitrazepam (FNP) in plasma and urine samples and to compare the results with those obtained by gas chromatography-mass spectrometry (GC-MS). The clinical study consisted of four individuals (two male and two female) who had taken a single 2-mg dose of FNP. Serum was collected over a 48-h period and urine was collected over a 72-h period. The serum and urine samples were analyzed by the COB...

  10. Protective immune response of oral rabies vaccine in stray dogs, corsacs and steppe wolves after a single immunization.

    Science.gov (United States)

    Zhugunissov, K; Bulatov, Ye; Taranov, D; Yershebulov, Z; Koshemetov, Zh; Abduraimov, Ye; Kondibayeva, Zh; Samoltyrova, A; Amanova, Zh; Khairullin, B; Sansyzbay, A

    2017-11-01

    In this study the safety and protective immunity of an oral rabies vaccine, based on the live, modified rabies virus strain VRC-RZ2, was examined in stray dogs (Canis Sp.), corsacs (Vulpes corsac) and steppe wolves (Canis lupus campestris). In the safety group (dogs, n=6; corsacs, n=3; wolves, n=3) which was vaccinated with a 10-times field dose/animal, no animals showed any signs of disease or changes in behavior or appetite during the period of clinical observation, similar to the animals in the negative control group. Saliva samples taken from animals prior and post (5 th and 10 th days) vaccination failed to demonstrate rabies virus antigen. Observations of immunogenicity in vaccinated carnivores (dogs, corsacs and wolves) during a 180 day period showed the titers of virus neutralizing antibodies (VNA) in the blood sera of vaccinated dogs to be within 0.59-1.37 IU/mL. On 14 days post vaccination (dpv), all the wild carnivores had detectable levels of neutralizing antibodies, with mean titers ranging from 0.50 ± 0.07 IU/mL (for wolves) to 0.59 ± 0.10 IU/mL (for corsacs). Weeks after vaccination, all the vaccinated wolves and corsacs had higher levels of neutralizing antibodies: 0.70 ± 0.10 - 0.71 ± 0.08 IU/mL at 30 dpv, 1.06 ± 0.08 - 1.28 ± 0.21 IU/mL at 60 dpv and 0.41 ± 0.09 - 047 ± 0.06 at 180 dpv. The highest level of VNA (˃1.0 IU/ml) was detected at 60 dpv, in all vaccinated animals. After challenge all vaccinated dogs remained healthy for 180 days. Control animals (unvaccinated dogs) developed symptoms of rabies on day 6 post administration of a virulent virus and died of rabies on days 11-13. Of note, the VNA titers in all the wild carnivores (corsacs and wolves) immunized with VRC-RZ2 were higher than 0.5 IU/ml (0.59 ± 0.11 IU/ml), even as early as 14 days post vaccination. These, presumably protective, titers of antibodies to rabies virus were present in the dogs and wild carnivores examined in this study for at

  11. A single-arm study to evaluate the efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel.

    Science.gov (United States)

    Taylor, Douglas J; Lendvay, Anja; Halpern, Vera; Bahamondes, Luis G; Fine, Paul M; Ginde, Savita Y; Wheeless, Angie; Raymond, Elizabeth G

    2014-03-01

    An oral dose of 0.75 mg levonorgestrel (LNG) taken shortly after sex was marketed as a routine, nonemergency contraceptive method until the 1990s. Because a hormonal method used only at the time of intercourse may be desirable for women who have infrequent sex, we conducted a study to reevaluate the potential of pericoital LNG as a primary means of contraception. We enrolled women aged 18-45 years in Brazil and the USA who expected to have sex 1-4 days per month for 6.5 months. Participants were instructed to take one tablet 0.75 mg LNG within 24 h before or after sex, with no more than one dose in any 24-h period. The primary efficacy measure was the Pearl Index among women aged 18-35 years. The study was stopped after 72 of the planned 300 participants were enrolled due to slow recruitment and related feasibility considerations. In the primary analysis, three pregnancies occurred during 13.4 woman-years of follow-up, resulting in a Pearl Index of 22.4 (95% confidence interval, 4.6-65.4). No serious adverse events were reported, and vaginal bleeding patterns were generally acceptable. Our estimated Pearl Index was noticeably higher than expected from previous research of LNG for pericoital contraception. Although the regimen was safe and generally acceptable, the study was challenged by slow enrollment and curtailed person-years of follow-up, resulting in poor precision for the estimated treatment effect. Future research may inform whether our results are symptomatic of the regimen, study design or characteristics of the populations from which we recruited. Our study failed to confirm prior data suggesting that 0.75 mg LNG for pericoital contraception could be more effective than typical use of barrier methods among women having infrequent sex. Characterizing populations most likely to adhere to, and benefit from, pericoital regimens is essential to future research on these methods. Copyright © 2014 Elsevier Inc. All rights reserved.

  12. Nitrogen balance after a single oral consumption of sacha inchi (Plukenetia volúbilis L.) protein compared to soy protein: a randomized study in humans.

    Science.gov (United States)

    Gonzales, Gustavo F; Tello, Jennifer; Zevallos-Concha, Alisson; Baquerizo, Luis; Caballero, Lidia

    2018-02-01

    Sacha inchi is a seed produced in the Peruvian Amazonian and its oil is recognized by the lowering lipids effect in humans. The remaining material transformed to flour has a higher amount of protein, but, the nitrogen balance once ingested orally has not been studied. The present study was designed to evaluate the nitrogen balance after single consumption of 30 g of sacha inchi flour and compared with that obtained after consumption of 30 g soybean flour in adult men and women. This was a double-blind cohort study in 15 men and 15 women between 18 and 55 years old. Fifteen subjects received soy meal and 15 subjects received sacha inchi meal. Group receiving sacha inchi flour has comparable initial parameters as those receiving soybean flour (p > 0.05). Blood samples at different times were obtained. Urine for 24 h was collected to calculate nitrogen balance, p sacha inchi and soybean groups (p sacha inchi or soy flour administration. The nitrogen balance was negative in the study but similar between both groups (p > 0.05). In conclusion, protein consumption of sacha inchi flour has the same nitrogen balance as soybean flour, shows acceptability for a single consumption and does not present serious adverse effects.

  13. Single Fasting Plasma Glucose Versus 75-g Oral Glucose-Tolerance Test in Prediction of Adverse Perinatal Outcomes: A Cohort Study.

    Science.gov (United States)

    Shen, Songying; Lu, Jinhua; Zhang, Lifang; He, Jianrong; Li, Weidong; Chen, Niannian; Wen, Xingxuan; Xiao, Wanqing; Yuan, Mingyang; Qiu, Lan; Cheng, Kar Keung; Xia, Huimin; Mol, Ben Willem J; Qiu, Xiu

    2017-02-01

    There remains uncertainty regarding whether a single fasting glucose measurement is sufficient to predict risk of adverse perinatal outcomes. We included 12,594 pregnant women who underwent a 75-g oral glucose-tolerance test (OGTT) at 22-28weeks' gestation in the Born in Guangzhou Cohort Study, China. Outcomes were large for gestational age (LGA) baby, cesarean section, and spontaneous preterm birth. We calculated the area under the receiver operator characteristic curves (AUCs) to assess the capacity of OGTT glucose values to predict adverse outcomes, and compared the AUCs of different components of OGTT. 1325 women had a LGA baby (10.5%). Glucose measurements were linearly associated with LGA, with strongest associations for fasting glucose (odds ratio 1.37, 95% confidence interval 1.30-1.45). Weaker associations were observed for cesarean section and spontaneous preterm birth. Fasting glucose have a comparable discriminative power for prediction of LGA to the combination of fasting, 1h, and 2h glucose values during OGTT (AUCs, 0.611 vs. 0.614, P=0.166). The LGA risk was consistently increased in women with abnormal fasting glucose (≥5.1mmol/l), irrespective of 1h or 2h glucose levels. A single fasting glucose measurement performs comparably to 75-g OGTT in predicting risk of having a LGA baby. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  14. Segmental-dependent membrane permeability along the intestine following oral drug administration: Evaluation of a triple single-pass intestinal perfusion (TSPIP) approach in the rat.

    Science.gov (United States)

    Dahan, Arik; West, Brady T; Amidon, Gordon L

    2009-02-15

    In this paper we evaluate a modified approach to the traditional single-pass intestinal perfusion (SPIP) rat model in investigating segmental-dependent permeability along the intestine following oral drug administration. Whereas in the traditional model one single segment of the intestine is perfused, we have simultaneously perfused three individual segments of each rat intestine: proximal jejunum, mid-small intestine and distal ileum, enabling to obtain tripled data from each rat compared to the traditional model. Three drugs, with different permeabilities, were utilized to evaluate the model: metoprolol, propranolol and cimetidine. Data was evaluated in comparison to the traditional method. Metoprolol and propranolol showed similar P(eff) values in the modified model in all segments. Segmental-dependent permeability was obtained for cimetidine, with lower P(eff) in the distal parts. Similar P(eff) values for all drugs were obtained in the traditional method, illustrating that the modified model is as accurate as the traditional, throughout a wide range of permeability characteristics, whether the permeability is constant or segment-dependent along the intestine. Three-fold higher statistical power to detect segmental-dependency was obtained in the modified approach, as each subject serves as his own control. In conclusion, the Triple SPIP model can reduce the number of animals utilized in segmental-dependent permeability research without compromising the quality of the data obtained.

  15. Impact of morning stiffness on working behaviour and performance in people with rheumatoid arthritis.

    Science.gov (United States)

    Mattila, Kalle; Buttgereit, Frank; Tuominen, Risto

    2014-12-01

    Work disability remains a considerable problem for many patients with rheumatoid arthritis (RA). Morning stiffness is a symptom of RA associated with early retirement from work and with impaired functional ability. We aimed to explore the patient's perception of the impact of morning stiffness on the working life of patients with RA. A survey was conducted in 11 European countries. Patients of working age, with RA for ≥6 months and morning stiffness ≥3 mornings a week, were interviewed by telephone using a structured questionnaire. Responses were assessed in the total sample and in subgroups defined by severity and duration of morning stiffness and by country. A total of 1,061 respondents completed the survey, 534 were working, 224 were retired and the rest were, i.e. homemakers and unemployed. Among the 534 working respondents, RA-related morning stiffness affected work performance (47 %), resulted in late arrival at work (33 %) and required sick leave in the past month (15 %). Of the 224 retired respondents, 159 (71 %) stopped working earlier than their expected retirement age, with 64 % giving RA-related morning stiffness as a reason. There was a differential impact of increasing severity and increasing duration of morning stiffness on the various parameters studied. There were notable inter-country differences in the impact of RA-related morning stiffness on ability to work and on retirement. This large survey showed that from the patient's perspective, morning stiffness reduces the ability to work in patients with RA and contributes to early retirement.

  16. Differences in morning and evening fatigue in oncology patients and their family caregivers.

    Science.gov (United States)

    Dhruva, Anand; Aouizerat, Bradley E; Cooper, Bruce; Paul, Steven M; Dodd, Marylin; West, Claudia; Wara, William; Lee, Kathryn; Dunn, Laura B; Langford, Dale J; Merriman, John D; Baggott, Christina; Cataldo, Janine; Ritchie, Christine; Kober, Kord; Leutwyler, Heather; Miaskowski, Christine

    2013-12-01

    To identify distinct latent classes of individuals based on ratings of morning and evening fatigue; evaluate for differences in phenotypic characteristics, as well as symptom and quality of life scores, among these latent classes; and evaluate for an overlap in morning and evening fatigue class membership. In a sample of 167 oncology outpatients and 85 of their FCs, growth mixture modeling was used to identify distinct latent classes based on ratings of morning and evening fatigue obtained before, during, and after radiation therapy. Analyses of variance and Chi Square analyses were used to evaluate for differences among the morning and evening fatigue latent classes. Three distinct latent classes for morning fatigue were identified. Participants in the High Morning Fatigue class (47%) were younger and had lower functional status. Three distinct latent classes for evening fatigue were identified. Participants in the High Evening Fatigue class (61%) were younger, more likely to be female, more likely to have children at home, and more likely to be a FC. Only 10.3% of participants were classified in both the Very Low Morning and Low Evening Fatigue classes and 41.3% were classified in both the High Morning and High Evening Fatigue classes. Different characteristics were associated with morning and evening fatigue, which suggests that morning and evening fatigue may be distinct but related symptoms. Additional research is needed to elucidate the mechanisms that may underlie diurnal variability in fatigue. Copyright © 2013 Elsevier Ltd. All rights reserved.

  17. Time of administration important? Morning versus evening dosing of valsartan.

    Science.gov (United States)

    Zappe, Dion H; Crikelair, Nora; Kandra, Albert; Palatini, Paolo

    2015-02-01

    Studies suggest that bedtime dosing of an angiotensin-converting enzyme (ACE)-inhibitor or angiotensin receptor blocker shows a more sustained and consistent 24-h antihypertensive profile, including greater night-time blood pressure (BP) reduction. We compared the antihypertensive effects of morning (a.m.) and evening (p.m.) dosing of valsartan on 24-h BP. This 26-week, multicentre, randomized, double-blind study evaluated the efficacy and safety of valsartan 320 mg, dosed a.m. or p.m., versus lisinopril 40 mg (a.m.), a long-acting ACE-inhibitor, in patients with grade 1-2 hypertension and at least one additional cardiovascular risk factor. Patients (n = 1093; BP = 156 ± 11/91 ± 8 mmHg; 62 years, 56% male, 99% white) received (1 : 1 : 1) valsartan 160 mg a.m. or p.m. or lisinopril 20 mg a.m. for 4 weeks, then force-titrated to double the initial dose for 8 weeks. At Week 12, hydrochlorothiazide (HCTZ) 12.5 mg was added for 14 weeks if office BP was more than 140/90 mmHg and/or ambulatory BP more than 130/80 mmHg. Mean 24-h ambulatory SBP change from baseline to Weeks 12 and 26 was comparable between valsartan a.m. (-10.6 and -13.3 mmHg) and p.m. (-9.8 and -12.3 mmHg) and lisinopril (-10.7 and -13.7 mmHg). There was no benefit of valsartan p.m. versus a.m. on night-time BP, early morning BP and morning BP surge. Evening dosing also did not improve BP lowering in patients requiring add-on HCTZ or in nondippers at baseline. All treatments were well tolerated. Once-daily dosing of valsartan 320 mg results in equally effective 24-h BP efficacy, regardless of dosing time. ClinicalTrials.gov Identifier: NCT00241124.

  18. Pharmacokinetics of a single oral dose of vitamin D3 (70,000 IU in pregnant and non-pregnant women

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    Roth Daniel E

    2012-12-01

    Full Text Available Abstract Background Improvements in antenatal vitamin D status may have maternal-infant health benefits. To inform the design of prenatal vitamin D3 trials, we conducted a pharmacokinetic study of single-dose vitamin D3 supplementation in women of reproductive age. Methods A single oral vitamin D3 dose (70,000 IU was administered to 34 non-pregnant and 27 pregnant women (27 to 30 weeks gestation enrolled in Dhaka, Bangladesh (23°N. The primary pharmacokinetic outcome measure was the change in serum 25-hydroxyvitamin D concentration over time, estimated using model-independent pharmacokinetic parameters. Results Baseline mean serum 25-hydroxyvitamin D concentration was 54 nmol/L (95% CI 47, 62 in non-pregnant participants and 39 nmol/L (95% CI 34, 45 in pregnant women. Mean peak rise in serum 25-hydroxyvitamin D concentration above baseline was similar in non-pregnant and pregnant women (28 nmol/L and 32 nmol/L, respectively. However, the rate of rise was slightly slower in pregnant women (i.e., lower 25-hydroxyvitamin D on day 2 and higher 25-hydroxyvitamin D on day 21 versus non-pregnant participants. Overall, average 25-hydroxyvitamin D concentration was 19 nmol/L above baseline during the first month. Supplementation did not induce hypercalcemia, and there were no supplement-related adverse events. Conclusions The response to a single 70,000 IU dose of vitamin D3 was similar in pregnant and non-pregnant women in Dhaka and consistent with previous studies in non-pregnant adults. These preliminary data support the further investigation of antenatal vitamin D3 regimens involving doses of ≤70,000 IU in regions where maternal-infant vitamin D deficiency is common. Trial registration ClinicalTrials.gov (NCT00938600

  19. Neighborhood-targeted and case-triggered use of a single dose of oral cholera vaccine in an urban setting: Feasibility and vaccine coverage.

    Science.gov (United States)

    Parker, Lucy A; Rumunu, John; Jamet, Christine; Kenyi, Yona; Lino, Richard Laku; Wamala, Joseph F; Mpairwe, Allan M; Muller, Vincent; Llosa, Augusto E; Uzzeni, Florent; Luquero, Francisco J; Ciglenecki, Iza; Azman, Andrew S

    2017-06-01

    In June 2015, a cholera outbreak was declared in Juba, South Sudan. In addition to standard outbreak control measures, oral cholera vaccine (OCV) was proposed. As sufficient doses to cover the at-risk population were unavailable, a campaign using half the standard dosing regimen (one-dose) targeted high-risk neighborhoods and groups including neighbors of suspected cases. Here we report the operational details of this first public health use of a single-dose regimen of OCV and illustrate the feasibility of conducting highly targeted vaccination campaigns in an urban area. Neighborhoods of the city were prioritized for vaccination based on cumulative attack rates, active transmission and local knowledge of known cholera risk factors. OCV was offered to all persons older than 12 months at 20 fixed sites and to select groups, including neighbors of cholera cases after the main campaign ('case-triggered' interventions), through mobile teams. Vaccination coverage was estimated by multi-stage surveys using spatial sampling techniques. 162,377 individuals received a single-dose of OCV in the targeted neighborhoods. In these neighborhoods vaccine coverage was 68.8% (95% Confidence Interval (CI), 64.0-73.7) and was highest among children ages 5-14 years (90.0%, 95% CI 85.7-94.3), with adult men being less likely to be vaccinated than adult women (Relative Risk 0.81, 95% CI: 0.68-0.96). In the case-triggered interventions, each lasting 1-2 days, coverage varied (range: 30-87%) with an average of 51.0% (95% CI 41.7-60.3). Vaccine supply constraints and the complex realities where cholera outbreaks occur may warrant the use of flexible alternative vaccination strategies, including highly-targeted vaccination campaigns and single-dose regimens. We showed that such campaigns are feasible. Additional work is needed to understand how and when to use different strategies to best protect populations against epidemic cholera.

  20. Acute administration of single oral dose of grape seed polyphenols restores blood pressure in a rat model of metabolic syndrome: role of nitric oxide and prostacyclin.

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    Pons, Zara; Margalef, Maria; Bravo, Francisca I; Arola-Arnal, Anna; Muguerza, Begoña

    2016-03-01

    The aims of this study were to evaluate the antihypertensive effectiveness of different doses of grape seed polyphenols in cafeteria diet-fed hypertensive rats (CHRs) and to establish the mechanism involved in the blood pressure (BP) lowering effect of these compounds in this experimental model of metabolic syndrome (MS). Male 8-week-old Wistar rats were fed cafeteria or standard (ST) diet for 10 weeks. After this, the antihypertensive effect of a single oral administration of a polyphenol grape seed extract (GSPE) was tested at different doses (250, 375 and 500 mg/kg) in CHRs. BP was recorded before and 2, 4, 6, 8, 24 and 48 h post-administration. The hypotensive effect of GSPE was also proved in ST diet-fed rats. Additionally, in other experiment, CHRs were orally administered 375 mg/kg GSPE. Four hours post-administration, the rats were intraperitoneally administrated 30 mg/kg NG-nitro-L-arginine methyl ester (L-NAME) or 5 mg/kg indomethacin [inhibitors of nitric oxide (NO) and prostacyclin synthesis, respectively]. BP was recorded initially and 6 h post-administration. GSPE produced a decrease in SBP and DBP, the most effective dose (375 mg/kg) showing an antihypertensive effect in CHRs similar to the drug captopril, and did not affect BP of ST diet-fed rats. The antihypertensive effect was completely abolished by L-NAME and partially inhibited by indomethacin. GSPE acts as an antihypertensive agent in a rat model of hypertension associated with MS. The change in endothelium-derived NO availability is one of the mechanisms involved in the antihypertensive effect of GSPE in CHRs. Additionally, endothelial prostacyclin contributes to the effect of GSPE on arterial BP.

  1. Pharmacokinetics and egg residues after oral administration of a single dose of meloxicam in domestic chickens (Gallus domesticus).

    Science.gov (United States)

    Souza, Marcy J; Bergman, Joan B; White, Molly S; Gordon, Kristen I; Gerhardt, Lillian E; Cox, Sherry K

    2017-08-01

    OBJECTIVE To determine the pharmacokinetics of meloxicam in domestic hens and duration and quantity of drug residues in their eggs following PO administration of a single dose (1 mg of meloxicam/kg). ANIMALS 8 healthy adult White Leghorn hens. PROCEDURES Hens were administered 1 mg of meloxicam/kg PO once. A blood sample was collected immediately before and at intervals up to 48 hours after drug administration. The hens' eggs were collected for 3 weeks after drug administration. Samples of the hens' plasma, egg whites (albumen), and egg yolks were analyzed by high-performance liquid chromatography. RESULTS The half-life, maximum concentration, and time to maximum concentration of meloxicam in plasma samples were 2.8 hours, 7.21 μg/mL, and 2 hours, respectively. Following meloxicam administration, the drug was not detected after 4 days in egg whites and after 8 days in egg yolks. CONCLUSIONS AND CLINICAL RELEVANCE Results indicated that meloxicam administered at a dose of 1 mg/kg PO in chickens appears to maintain plasma concentrations equivalent to those reported to be therapeutic for humans for 12 hours. The egg residue data may be used to aid establishment of appropriate drug withdrawal time recommendations.

  2. Natural gum modified emulsion gel as single carrier for the oral delivery of probiotic-drug combination.

    Science.gov (United States)

    Pandey, S; Senthilguru, K; Uvanesh, K; Sagiri, S S; Behera, B; Babu, N; Bhattacharyya, M K; Pal, K; Banerjee, I

    2016-11-01

    Single formulation based delivery of probiotic-drug combination is envisioned as a superior therapeutic delivery modality for the diseases like Crohn's diseases, ulceritive colitis and Recurrent Clostridium difficile-Associated Diarrhoea (RCDAD). Keeping this perspective in mind, here we have developed natural gum [using a combination of aqueous solution of xantham gum (X) and guar gum (G)] modified sunflower oil based emulsion gels for the delivery of probiotics-drugs combination. FT-IR analysis and fluorescence microscopy together confirmed the formation of oil-in-water type emulsion gel by physical gelation in presence of the physical gelator sorbitan monopalmitate (SM). Other studies (XRD, DSC, mechanical properties and disintegration study) revealed that the variation in relative proportion of the two gums has a sporadic but significant effect on the physico-chemical properties of the gel. Post storage viability of commercially used probiotic Lactobacillus plantarum 299v (Lp 299v) at different storage conditions (4°C, -20°C, -196°C) was found higher in the emulsion gels with respect to the control. Moreover, the gels were found suitable for sustained delivery of metronidazole (the lipophilic drug often used with Lp 299v). In conclusion, the natural gum modified emulsion gel may be used as a delivery system for the probiotic-drug combination. Copyright © 2016 Elsevier B.V. All rights reserved.

  3. Early morning – A temporal interstice in urban life

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    Andrea Mubi Brighenti

    2014-05-01

    Full Text Available Early morning is a critical threshold in daily urban rhythms1. But exactly, a threshold between what and what? As known, the Western imagination of the city is premised upon some overarching dichotomies, some great divides. In spatial terms, the city/countryside divide, or the city/territory, serves as a distinction which has traditionally informed the way we make sense of the urban experience at large. Indeed, urbanism – as opposed to ruralism – has been classically associated with human density, social heterogeneity, impersonal role-based interaction and segmental human relations. And incidentally, sociology as a discipline was born precisely as an investigation into this divide, then phrased as traditional versus modern, or mechanic versus organic.

  4. Enhancing resident morning report with "daily learning packages".

    Science.gov (United States)

    Weaver, Debbie

    2011-01-01

    The daily "Morning Report" is a fixture in many residency programs. In the past, librarians have attended this meeting and, in various ways, worked to enhance the resident learning experience. At the academic children's hospital discussed in this study, the concept was taken a step further. Together with the chief residents, the librarian provided a complete "learning package" consisting of the case write-up along with relevant, librarian-filtered, evidence-based information. The learning package was then e-mailed to all residents and some of the attending physicians. This program led to a huge increase in the use of library resources and services as well as a renewed recognition of the value of the library and the librarians.

  5. Morning Glory Syndrome with Carotid and Middle Cerebral Artery Vasculopathy.

    Science.gov (United States)

    Nezzar, Hachemi; Mbekeani, Joyce N; Dalens, Helen

    2015-12-01

    To report a case of incidental asymptomatic atypical morning glory syndrome (MGS) with concomitant ipsilateral carotid and middle cerebral dysgenesis. A 6-year-old child was discovered to have incidental findings of MGS, with atypia. All visual functions were normal including vision and stereopsis. Neuroimaging revealed ipsilateral carotid and middle cerebral vascular narrowing without associated collateral vessels or cerebral ischemia commonly seen in Moyamoya disease. Subsequent annual examinations have been stable, without signs of progression. This case demonstrates disparity between structural aberrations and final visual and neurological function and reinforces the association between MGS and intracranial vascular disruption. Full ancillary ophthalmic and neuroimaging studies should be performed in all patients with MGS with interval reassessments, even when the patient is asymptomatic and functionally intact.

  6. Pharmacokinetics of a single dose of voriconazole administered orally with and without food to red-tailed hawks (Buteo jamaicensus).

    Science.gov (United States)

    Parsley, Ruth A; Tell, Lisa A; Gehring, Ronette

    2017-04-01

    OBJECTIVE To determine the pharmacokinetics of voriconazole administered PO with or without food to red-tailed hawks (Buteo jamaicensus) and whether any observed variability could be explained by measured covariates to inform dose adjustments. ANIMALS 7 adult red-tailed hawks. PROCEDURES In a crossover study design, hawks were randomly assigned to first receive voriconazole (15 mg/kg, PO) injected into a dead mouse (n = 3; fed birds) or without food (4; unfed birds). Sixteen days later, treatments were reversed. Blood samples were collected at various points to measure plasma voriconazole concentrations by ultraperformance liquid chromatography. Pharmacokinetic data were analyzed by noncompartmental methods and fit to a compartmental model through nonlinear mixed-effects regression, with feeding status and body weight investigated as covariates. RESULTS Voriconazole was well absorbed, with quantifiable plasma concentrations up to 24 hours after administration. Mean plasma half-life was approximately 2 hours in fed and unfed birds. Administration of the voriconazole in food delayed absorption, resulting in a significant delay in time to maximum plasma concentration. The final compartmental model included a categorical covariate to account for this lag in absorption as well as body weight as a covariate of total body clearance (relative to unknown bioavailability). CONCLUSIONS AND CLINICAL RELEVANCE A single dose of voriconazole (15 mg/kg) administered PO to red-tailed hawks resulted in mean plasma voriconazole concentrations greater than the targeted value (1 μg/mL). Additional studies with larger sample sizes and multidose regimens are required before the model developed here can be applied in clinical settings.

  7. Pharmacokinetics and Safety of a Single Oral Dose of Mirogabalin in Japanese Subjects With Varying Degrees of Renal Impairment.

    Science.gov (United States)

    Kato, Manabu; Tajima, Naoyuki; Shimizu, Takako; Sugihara, Masahiro; Furihata, Kenichi; Harada, Kazuhiro; Ishizuka, Hitoshi

    2018-01-01

    Mirogabalin (DS-5565) is a novel preferentially selective α 2 δ-1 ligand being developed for the treatment of diabetic peripheral neuropathic pain and postherpetic neuralgia. The current multicenter open-label study determined the effect of varying degrees of renal impairment on the pharmacokinetics and safety of a single dose of mirogabalin 5 mg in Japanese subjects. A total of 30 subjects (6 subjects per renal function category [normal, mild, moderate, or severe impairment; and end-stage renal disease (ESRD)]) were enrolled and completed the study. The AUC last increased with severity of renal impairment; the geometric least-squares mean ratios of AUC last compared with subjects with normal renal function were 1.3, 1.9, 3.6, and 5.3 for patients with mild, moderate, and severe impairment and ESRD, respectively. In accordance with this AUC last increase, apparent total body clearance (CL/F), renal clearance (CLr), and the cumulative percentage of mirogabalin dose excreted into urine all decreased with severity of renal impairment. There were no deaths and no severe treatment-related adverse events (TEAEs), serious TEAEs, or TEAEs resulting in study discontinuation. Mirogabalin was well tolerated in Japanese subjects with normal renal function and those with mild to severe renal impairment. It was also tolerated in subjects with ESRD but with a higher incidence of TEAEs. The most frequently reported TEAEs were dizziness (ESRD, n = 3), somnolence (ESRD, n = 2), and vomiting (ESRD, n = 2). Based on these data, a mirogabalin dose adjustment will be considered in Japanese subjects with moderate to severe renal impairment and those with ESRD. © 2017, The Authors. The Journal of Clinical Pharmacology published by Wiley Periodicals, Inc. on behalf of American College of Clinical Pharmacology.

  8. Increased Level of Morning Surge in Blood Pressure in Normotensives: ACross-Sectional Study from Pakistan.

    Science.gov (United States)

    Almas, Aysha; Sultan, Fatehali Tipoo; Kazmi, Khawar

    2016-10-01

    To determine the mean morning surge (MS) in blood pressure, the frequency of increased morning surge in normotensive subjects, and to compare those with morning surge with those without MS. Across-sectional, comparative study. The Department of Medicine, The Aga Khan University Hospital, Karachi, from April 2011 to March 2012. Adult normotensive healthy volunteers aged 35 to 65 years were inducted. Their ambulatory blood pressure (ABP) was measured over a 24-hour period, using digital ambulatory blood pressure monitors. Morning surge was calculated as the average of four readings after waking minus the lowest three nocturnal readings. Increased morning surge was defined as > 11 mm Hg in systolic (SBP) or > 12 mm Hg in diastolic (DBP). Dipping was defined as > 10% dipping in blood pressure. Eighty-two healthy volunteers were recruited. Their mean age was 36.9 ±1.2 years; 74.4 (61%) were men, and 58.5 (48%) woke up for morning prayers. Mean overall SBPwas 113 ±1.6 mm Hg, overall DBPwas 73.9 ±0.7 mm Hg, and overall heart rate was 75 (10) beats/minute. Mean morning surge was 17.6 ±1.0 mm Hg in SBPand 16.0 ±0.8 mm Hg in DBP. The frequency of increased morning surge was 66 (80.5%) in SBP, and 57 (69%) in DBP. On comparison of participants with normal morning surge and increased morning surge in SBP, there was a significant difference in nondipping status (13.4% in normal vs. 18.3% in increased morning surge, p= 0.001). Mean morning surge in SBPand DBPare relatively higher in this subset population in a tertiary care center in Pakistan. These values are higher than those reported in the literature.

  9. Severity and Diurnal Improvement of Morning Stiffness Independently Associate with Tenosynovitis in Patients with Rheumatoid Arthritis.

    Science.gov (United States)

    Kobayashi, Yoshihisa; Ikeda, Kei; Nakamura, Takayuki; Yamagata, Mieko; Nakazawa, Takuya; Tanaka, Shigeru; Furuta, Shunsuke; Umibe, Takeshi; Nakajima, Hiroshi

    2016-01-01

    Although morning stiffness has long been recognized as a characteristic feature of rheumatoid arthritis (RA), it is no more included in the 2010 ACR/EULAR Classification Criteria or in the current major instruments for evaluating disease activity of RA. In this cross-sectional study, we aimed to determine the independent value and the optimal measurement of morning stiffness by clarifying the associations between morning stiffness and synovial inflammation. We enrolled 76 consecutive RA patients who underwent musculoskeletal ultrasound examination and agreed to participate in the study. In addition to asking the duration of morning stiffness, we asked patients to complete a diagram which represents the time course of their morning stiffness in the dominant hand. Based on this diagram, we calculated the severity and the diurnal improvement of morning stiffness. We also determined the activity of intra-articular synovitis in 11 joints and tenosynovitis in 8 tendons/tendon compartments in the same hand by using power Doppler (PD) ultrasound with a semiquantitative score (0-3). For intra-articular synovitis, swollen/tender joint counts more strongly correlated with total PD scores (ρ = 0.379-0.561, p ≤ 0.001) than did any parameters of morning stiffness (ρ = 0.217-0.314, p = 0.006-0.021). For tenosynovitis, however, the severity on awakening and the improvement of morning stiffness more strongly correlated with total PD scores (ρ = 0.503-0.561, p morning stiffness as factors that independently associate with the total tenosynovial PD score. Our data demonstrate a pathophysiological link between morning stiffness and tenosynovitis and also give an insight into the optimal measurement of morning stiffness. Our data support an independent value of evaluating morning stiffness in the management of RA.

  10. Oral Liquid Formulation of Levothyroxine Is Stable in Breakfast Beverages and May Improve Thyroid Patient Compliance

    Directory of Open Access Journals (Sweden)

    Alberto Bernareggi

    2013-12-01

    Full Text Available Patients on treatment with levothyroxine (T4 are informed to take this drug in the morning, at least 30 min before having breakfast. A significant decrease of T4 absorption was reported, in fact, when T4 solid formulations are taken with food or coffee. According to preliminary clinical study reports, administration of T4 oral solution appears to be less sensitive to the effect of breakfast beverages on oral bioavailability. In the present study, stability of T4 oral solution added to breakfast beverages was investigated. A 1 mL ampoule of single-dose Tirosint® oral solution (IBSA Farmaceutici Italia, Lodi, Italy was poured into defined volumes of milk, tea, coffee, and coffee with milk warmed at 50 °C, as well as in orange juice at room temperature. Samples were sequentially collected up to 20 min and analyzed by validated liquid chromatography-tandem mass spectrometry (LC-MS/MS methods. The results of the study demonstrated that T4 is stable in all beverages after 20 min incubation. Demonstration of T4 stability is a prerequisite for a thorough evaluation of the effect of breakfast beverages on the bioavailability of T4 given as oral solution and for a better understanding of the reasons underlying a decreased T4 bioavailability administered as solid formulations.

  11. Association between morning symptoms and physical activity in COPD: a systematic review.

    Science.gov (United States)

    van Buul, Amanda R; Kasteleyn, Marise J; Chavannes, Niels H; Taube, Christian

    2017-01-01

    Morning symptoms are common in chronic obstructive pulmonary disease (COPD). Many COPD patients consider the morning as the most troublesome part of the day, in which they experience more symptoms and physical activity limitations.To systematically report evidence of the association between morning symptoms and physical activity in COPD patients, a literature search was conducted using relevant MESH terms and text words in PubMed, Embase, Web of Science, COCHRANE, CINAHL and PsycINFO. Quality of the articles was assessed with validated checklists.Eight studies were included. Morning symptoms were present in 39.8-94.4%. In 37.0-90.6% of all COPD patients, there was an association between physical activity and morning symptoms. However, causality could not be proved. Morning symptoms were associated with a sedentary lifestyle (pmorning symptoms (pmorning symptoms which are negatively associated with physical activity. Physicians should consider morning symptoms as a treatment goal. Pharmacotherapy may improve the degree of activity limitations due to morning symptoms. More objective research should focus on symptoms, activity limitations and physical inactivity of COPD patients, especially in the morning. Copyright ©ERS 2017.

  12. Time and age trends in morning and evening protein intakes of German children and adolescents.

    Science.gov (United States)

    Roßbach, Sarah; Diederichs, Tanja; Herder, Christian; Buyken, Anette E; Alexy, Ute

    2018-01-01

    The present study describes time and age trends in morning and evening protein intakes and sources among German children and adolescents from 1985 to 2014. A total of 9757 three-day weighed dietary records of 1246 3- to 18-year-old participants of the Dortmund Nutritional and Anthropometric Longitudinally Designed (DONALD) study were analysed using polynomial mixed-effects regression models. Morning protein intake increased over the study period by approximately 1 % of morning energy intake (linear trend P morning and evening protein intakes increased modestly between 1985 and 2014; these increases were, however, not accompanied by increases in traditional protein sources (i.e. meat or dairy products).

  13. Efficacy of a single-dose regimen of inactivated whole-cell oral cholera vaccine: results from 2 years of follow-up of a randomised trial.

    Science.gov (United States)

    Qadri, Firdausi; Ali, Mohammad; Lynch, Julia; Chowdhury, Fahima; Khan, Ashraful Islam; Wierzba, Thomas F; Excler, Jean-Louis; Saha, Amit; Islam, Md Taufiqul; Begum, Yasmin A; Bhuiyan, Taufiqur R; Khanam, Farhana; Chowdhury, Mohiul I; Khan, Iqbal Ansary; Kabir, Alamgir; Riaz, Baizid Khoorshid; Akter, Afroza; Khan, Arifuzzaman; Asaduzzaman, Muhammad; Kim, Deok Ryun; Siddik, Ashraf U; Saha, Nirod C; Cravioto, Alejandro; Singh, Ajit P; Clemens, John D

    2018-03-14

    A single-dose regimen of inactivated whole-cell oral cholera vaccine (OCV) is attractive because it reduces logistical challenges for vaccination and could enable more people to be vaccinated. Previously, we reported the efficacy of a single dose of an OCV vaccine during the 6 months following dosing. Herein, we report the results of 2 years of follow-up. In this placebo-controlled, double-blind trial done in Dhaka, Bangladesh, individuals aged 1 year or older with no history of receipt of OCV were randomly assigned to receive a single dose of inactivated OCV or oral placebo. The primary endpoint was a confirmed episode of non-bloody diarrhoea for which the onset was at least 7 days after dosing and a faecal culture was positive for Vibrio cholerae O1 or O139. Passive surveillance for diarrhoea was done in 13 hospitals or major clinics located in or near the study area for 2 years after the last administered dose. We assessed the protective efficacy of the OCV against culture-confirmed cholera occurring 7-730 days after dosing with both crude and multivariable per-protocol analyses. This trial is registered at ClinicalTrials.gov, number NCT02027207. Between Jan 10, 2014, and Feb 4, 2014, 205 513 people were randomly assigned to receive either vaccine or placebo, of whom 204 700 (102 552 vaccine recipients and 102 148 placebo recipients) were included in the per-protocol analysis. 287 first episodes of cholera (109 among vaccine recipients and 178 among placebo recipients) were detected during the 2-year follow-up; 138 of these episodes (46 in vaccine recipients and 92 in placebo recipients) were associated with severe dehydration. The overall incidence rates of initial cholera episodes were 0·22 (95% CI 0·18 to 0·27) per 100 000 person-days in vaccine recipients versus 0·36 (0·31 to 0·42) per 100 000 person-days in placebo recipients (adjusted protective efficacy 39%, 95% CI 23 to 52). The overall incidence of severe cholera was 0·09 (0·07 to 0

  14. Pharmacokinetics and effects of demographic factors on blood 25(OH)D3 levels after a single orally administered high dose of vitamin D3.

    Science.gov (United States)

    Chen, Pei-Zhan; Li, Mian; Duan, Xiao-Hua; Jia, Jing-Ying; Li, Jing-Quan; Chu, Rui-Ai; Yu, Chen; Han, Jun-Hua; Wang, Hui

    2016-11-01

    To examine the biological consequences and demographic factors that might affect the pharmacokinetics of vitamin D3 after a single high dose intervention in a young Chinese population with vitamin D insufficiency status. A total of 28 young subjects (25 to 35 years old) with vitamin D insufficiency status [serum 25(OH)D vitamin D3 (300 000 IU). Baseline characteristics and blood samples were collected at d 0, 1, 2, 3, 7, 28, 56, 84 and 112 after the intervention. The blood biomarker levels were determined with standardized methods. The intervention markedly increased the blood 25(OH)D3 levels within the first five days (mean T max =5.1±2.1 d) and sustained an optimal circulating level of 25(OH)D3 (≥30 ng/mL) for 56 d. After the intervention, body weight and baseline 25(OH)D3 levels were significantly correlated with circulating 25(OH)D3 levels. No adverse events and no consistently significant changes in serum calcium, creatinine, glucose, parathyroid hormone, vitamin D binding protein, or the urinary calcium/reatinine ratio were observed. However, there was a significant increase in phosphorus after the vitamin D3 intervention. Total cholesterol and triglyceride levels were decreased at the end of the trial. The pharmacokinetics of vitamin D after intervention were influenced by baseline 25(OH)D3 levels and the body weight of the subjects. The results suggest that a single high oral vitamin D3 intervention is safe and efficient for improving the vitamin D status of young Chinese people with vitamin D insufficiency.

  15. Worlds Apart – Transcriptome Profiles of Key Oral Microbes in the Periodontal Pocket Compared to Single Laboratory Culture Reflect Synergistic Interactions

    Directory of Open Access Journals (Sweden)

    Zhi-Luo Deng

    2018-02-01

    Full Text Available Periodontitis is a worldwide prevalent oral disease which results from dysbiosis of the periodontal microbiome. Some of the most active microbial players, e.g., Porphyromonas gingivalis, Treponema denticola, and Fusobacterium nucleatum, have extensively been studied in the laboratory, but it is unclear to which extend these findings can be transferred to in vivo conditions. Here we show that the transcriptional profiles of P. gingivalis, T. denticola, and F. nucleatum in the periodontal niche are distinct from those in single laboratory culture and exhibit functional similarities. GO (gene ontology term enrichment analysis showed up-regulation of transporters, pathogenicity related traits and hemin/heme uptake mechanisms for all three species in vivo. Differential gene expression analysis revealed that cysteine proteases, transporters and hemin/heme-binding proteins were highly up-regulated in the periodontal niche, while genes involved in DNA modification were down-regulated. The data suggest strong interactions between those three species regarding protein degradation, iron up-take, and mobility in vivo, explaining their enhanced synergistic pathogenicity. We discovered a strikingly high frequency of Single Nucleotide Polymorphisms (SNPs in vivo. For F. nucleatum we discovered a total of 127,729 SNPs in periodontal niche transcripts, which were found in similar frequency in health and disease and covered the entire genome, suggesting continuous evolution in the host. We conclude that metabolic interactions shape gene expression in vivo. Great caution is required when inferring pathogenicity of microbes from laboratory data, and microdiversity is an important adaptive trait of natural communities.

  16. One-piece zirconia oral implants for single-tooth replacement: Three-year results from a long-term prospective cohort study.

    Science.gov (United States)

    Kohal, Ralf-Joachim; Spies, Benedikt C; Bauer, Annalena; Butz, Frank

    2018-01-01

    This 3-year report of a prospective long-term cohort investigation aimed to evaluate the clinical and radiographic outcomes of a one-piece zirconia oral implant for single-tooth replacement. Sixty-five patients received a 1-stage implant surgery with immediate temporization. Standardized radiographs were taken at implant insertion, after 1 year, and after 3 years to monitor peri-implant bone levels. A univariate analysis of the association of different baseline parameters on marginal bone loss from implant insertion to 36 months was performed. Soft-tissue parameters were evaluated at prosthesis insertion, after 6 months, after 1 year, and at the 3-year follow-up. After 3 years, six posterior site implants were lost, giving a cumulative survival rate of 90.8%. The mean marginal bone loss was 1.45 mm; 35% of the implants lost at least 2 mm bone, and 22% more than 3 mm. The univariate analysis did not identify any parameter associated with marginal bone loss. Probing depth, clinical attachment level, and bleeding index increased over 3 years, and plaque index decreased. The low survival rate of the presented ceramic implant and especially the high frequency of advanced bone loss are noticeable but remain unexplained. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  17. All-Ceramic Single Crown Restauration of Zirconia Oral Implants and Its Influence on Fracture Resistance: An Investigation in the Artificial Mouth

    Directory of Open Access Journals (Sweden)

    Ralf-Joachim Kohal

    2015-04-01

    Full Text Available The aim of the current investigation was to evaluate the fracture resistance of one-piece zirconia oral implants with and without all-ceramic incisor crowns after long-term thermomechanical cycling. A total of 48 implants were evaluated. The groups with crowns (C, 24 samples and without crowns (N, 24 samples were subdivided according to the loading protocol, resulting in three groups of 8 samples each: Group “0” was not exposed to cyclic loading, whereas groups “5” and “10” were loaded with 5 and 10 million chewing cycles, respectively. This resulted in 6 different groups: C0/N0, C5/N5 and C10/N10. Subsequently, all 48 implants were statically loaded to fracture and bending moments were calculated. All implants survived the artificial aging. For the static loading the following average bending moments were calculated: C0: 326 Ncm; C5: 339 Ncm; C10: 369 Ncm; N0: 339 Ncm; N5: 398 Ncm and N10: 355 Ncm. To a certain extent, thermomechanical cycling resulted in an increase of fracture resistance which did not prove to be statistically significant. Regarding its fracture resistance, the evaluated ceramic implant system made of Y-TZP seems to be able to resist physiological chewing forces long-term. Restauration with all-ceramic single crowns showed no negative influence on fracture resistance.

  18. Milk transfer, distribution, and metabolism of a single oral dose of [14CH3S]methamidophos in Sprague Dawley rats

    International Nuclear Information System (INIS)

    Bakry, N.M.; Salama, A.K.; Aly, H.A.; Abou-Donia, M.B.

    1990-01-01

    A single oral dose of 8 mg/kg (8 μci/kg) of [ 14 CH 3 S]methamidophos was administered to the dams right after delivery. Suckling groups were collected at intervals of 1, 3, 6, 12, 24, 36, and 48 hr after dosing. Radiolabeled material was rapidly absorbed and subsequently distributed throughout the body. Generally, the highest concentration of radioactivity were associated with kidneys, liver, lung, small intestine, spleen, stomach, and uterus; the lowest were found in the heart, muscles, skin, diaphragm, brain, spinal cord, and adipose tissues. Total radioactivity in the sucklings reached a maximum value of 1,067 ng methamidophos equivalent (1.89% of applied dose). Methamidophos and its metabolites were analyzed by gas-liquid chromatography/mass spectrometry, thin-layer chromatography and liquid scintillation counting. Methamidophos disappeared biexponentially from the suckling pups. The terminal half-life of methamidophos was 43.5 hr corresponding to a constant rate value of 0.02 hr -1 . The major metabolites in the sucklings were monomethyl phosphoroamidate and monomethyl phosphate

  19. 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.

  20. Determination of influence of food intake after a single oral dose of mosapride in beagle dogs using nonlinear mixed effect modeling.

    Science.gov (United States)

    Chae, J-W; Hwang, J-A; Baek, I-H; Pradhan, S; Song, B; Back, H-M; Yun, M; Pai, C; Bang, J S; Yun, H-Y; Kang, W; Kwon, K-I

    2015-12-01

    The objective of this study was to describe the population pharmacokinetics (PK) of mosapride under fasting and fed conditions. A single 5-mg oral dose of mosapride was administered to fasted (n = 15) and fed (n = 12) beagle dogs. Plasma concentrations of mosapride were subsequently measured by liquid chromatography-tandem mass spectrometry. Data were analyzed using modeling approaches with the NONMEM 7.2 software. A one-compartment open PK model utilizing model event time (MTIME) with first-order absorption and first-order elimination was found to be more appropriate than all other PK models tested. The absorption rate constants of mosapride were significantly decreased under fed conditions, compared to fasting conditions. The observed bootstrap medians of PK parameters were generally consistent with the corresponding population mean estimates. Furthermore, with the exception of some mosapride concentrations, most of observed data fell into the range of the 5th and 95th percentiles of the simulated values. Overall, the final model was able to describe the observed mosapride concentrations reasonably well. These findings suggest that food intake affects both the rate and extent of absorption of mosapride and that the pharmacological effect of mosapride can differ significantly depending on food intake. © 2015 John Wiley & Sons Ltd.

  1. 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.

  2. The association between objectively measured physical activity and morning symptoms in COPD.

    Science.gov (United States)

    van Buul, Amanda R; Kasteleyn, Marise J; Chavannes, Niels H; Taube, Christian

    2017-01-01

    The morning is the most bothersome period for COPD patients. Morning symptom severities in different Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages are not well studied. Furthermore, factors that are associated with morning symptoms, especially the associations with objectively measured physical activity, are also not well described. The aim of this cross-sectional observational study was to assess morning symptom severity in GOLD A, B, C and D patients, according to the definitions of the GOLD 2015 statement. Morning symptoms were assessed with the PRO-Morning COPD Symptoms Questionnaire. Differences in morning symptom severity between different COPD stages were assessed with a one-way analysis of variance followed by post hoc analyses. The association between dyspnea severity (assessed with the modified Medical Research Council scale), health status, airflow limitation, lung hyperinflation, anxiety and depression, inflammatory parameters, exacerbations, objectively measured physical activity parameters retrieved from accelerometry and morning symptom severity was evaluated using linear regression analysis. Eighty patients were included (aged 65.6±8.7 years, forced expiratory volume in 1 second [FEV 1 ] % predicted 55.1±16.9). Mean (±SD) morning symptom score was 19.7 (±11.7). Morning symptom severity was significantly different between COPD stages: mean (±SD) score in GOLD A was 9.7 (±7.2), in GOLD B 19.8 (±10.7), in GOLD C 8.6 (±9.3) and in GOLD D 23.8 (±11.2) ( p morning symptom severity. Patients with overall more symptomatic COPD have significant higher morning symptom scores. Morning symptom severity was associated with important clinical outcomes: lower health status, more symptoms, increased anxiety and depression, fewer steps a day, less time in moderate and vigorous physical activity with bouts of at least 10 minutes and lower FEV 1 . The data suggest that morning symptoms should be carefully assessed in addition to

  3. Losartan/hydrochlorothiazide combination is safe and effective for morning hypertension in Very-Elderly patients.

    Science.gov (United States)

    Uchiwa, Hiroki; Kai, Hisashi; Iwamoto, Yoshiko; Anegawa, Takahiro; Kajimoto, Hidemi; Fukuda, Kenji; Imaizumi, Tsutomu; Fukumoto, Yoshihiro

    2018-01-01

    Morning hypertension is an independent risk for cerebrovascular and cardiovascular events. Although the prevalence of morning hypertension increases with age, treatment of morning hypertension has not been established, particularly in Very-Elderly patients. We compared the safety and efficacy of a losartan/hydrochlorothiazide (HCTZ) combination in controlling morning hypertension between Very-Elderly (≥75 years) and Young/Elderly patients (Morning Hypertension and Angiotensin Receptor Blocker/Hydrochlorothiazide Combination Therapy study, in which patients with morning hypertension (≥135/85 mmHg) received a 50-mg losartan/12.5-mg HCTZ combination tablet (combination therapy) or 100-mg losartan (high-dose therapy) for 3 months. High adherence rates and few adverse effects were observed in Very-Elderly patients receiving combination (n = 32) and high-dose (n = 34) therapies and in Young/Elderly patients receiving combination (n = 69) and high-dose (n = 66) therapies. Baseline morning systolic BP (SBP) was similar in both age groups receiving either therapy. Morning SBP was reduced by 20.2 and 18.1 mmHg with combination therapy and by 7.1 and 9.1 mmHg with high-dose therapy in the Very-Elderly and Young/Elderly patients, respectively. Morning BP target (morning hypertension in Very-Elderly as well as Young/Elderly patients. In addition, combination therapy was also superior to high-dose therapy for lowering morning SBP in Very-Elderly patients.

  4. Patient's Perception of Symptoms Related to Morning Activity in Chronic Obstructive Pulmonary Disease: The SYMBOL Study

    Science.gov (United States)

    Kim, Yeon Jae; Lee, Byung Ki; Jung, Chi Young; Jeon, Young June; Hyun, Dae Sung; Kim, Kyung Chan; Yu, Sung Ken; Choi, Hye Sook; Shin, Won Hyuk

    2012-01-01

    Background/Aims Patients with chronic obstructive pulmonary disease (COPD) experience more problematic respiratory symptoms and have more trouble performing daily activities in the morning. The aim of this study was to assess the perception of COPD symptoms related to morning activities in patients with severe airflow limitation. Methods Data of 133 patients with severe airflow limitation were analyzed in a prospective, non-interventional study. A clinical symptom questionnaire was completed by patients at baseline. In patients having morning symptoms, defined by at least one or more prominent or aggravating symptom during morning activities, a morning activity questionnaire was also completed at baseline and following 2 months of COPD treatment. Results The most frequently reported COPD symptom was breathlessness (90.8%). Morning symptoms were reported in 76 (57%) patients; these had more frequent and severe clinical COPD symptoms. The most frequently reported morning activity was getting out of bed (82.9%). The long acting muscarinic antagonist (odds ratio [OR], 6.971; 95% confidence interval [CI], 1.317 to 11.905) and chest tightness (OR, 0.075; 95% CI, 0.011 to 0.518) were identified as significantly related to absence of morning symptoms. There was no significant correlation between the degree of forced expiratory volume in 1 second improvement and severity score differences of all items of morning activity after 2-month treatment. Conclusions Fifty-seven percent of COPD patients with severe airflow limitation have morning symptoms that limit their morning activities. These patients also have more prevalent and severe COPD symptoms. The results of this study therefore provide valuable information for the development of patient-reported outcomes in COPD. PMID:23269884

  5. Morning blood pressure surge is associated with arterial stiffness and sympathetic baroreflex sensitivity in hypertensive seniors

    Science.gov (United States)

    Okada, Yoshiyuki; Galbreath, M. Melyn; Shibata, Shigeki; Jarvis, Sara S.; Bivens, Tiffany B.; Vongpatanasin, Wanpen; Levine, Benjamin D.

    2013-01-01

    Morning blood pressure (BP) surge is considered to be an independent risk factor for cardiovascular diseases. We tested the hypothesis that increased large-artery stiffness and impaired sympathetic baroreflex sensitivity (BRS) contribute to augmented morning surge in elderly hypertensive subjects. Morning surge was assessed as morning systolic BP averaged for 2 h just after waking up minus minimal sleeping systolic BP by using ambulatory BP monitoring (ABPM) in 40 untreated hypertensive [68 ± 1 (SE) yr] and 30 normotensive (68 ± 1 yr) subjects. Beat-by-beat finger BP and muscle sympathetic nerve activity (MSNA) were recorded in the supine position and at 60° upright tilt. We assessed arterial stiffness with carotid-to-femoral pulse wave velocity (cfPWV) and sympathetic BRS during spontaneous breathing. Awake and asleep ABPM-BPs and morning surge were higher in hypertensive than normotensive subjects (all P morning surge ≥35 mmHg (median value) had higher cfPWV (11.9 ± 0.5 vs. 9.9 ± 0.4 m/s, P = 0.002) and lower sympathetic BRS (supine: −2.71 ± 0.25 vs. −3.73 ± 0.29, P = 0.011; upright: −2.62 ± 0.22 vs. −3.51 ± 0.35 bursts·100 beats−1·mmHg−1, P = 0.052) than those with morning surge 0.05), while upright total peripheral resistance was higher in hypertensive subjects with greater morning surge than those with lesser morning surge (P = 0.050). Morning surge was correlated positively with cfPWV (r = 0.59, P morning BP surge is associated with arterial stiffness and sympathetic BRS, as well as vasoreactivity during orthostasis in hypertensive seniors. PMID:23832695

  6. Morning cortisol is lower in obese individuals with normal glucose tolerance

    Directory of Open Access Journals (Sweden)

    Praveen EP

    2011-09-01

    Full Text Available Edavan P Praveen1, Jaya Prakash Sahoo1, Bindu Kulshreshtha2, Madan L Khurana3, Nandita Gupta1, Sada Nand Dwivedi3, Guresh Kumar3, Ariachery C Ammini11Department of Endocrinology, All India Institute of Medical Sciences, 2Ram Manohar Lohia Hospital, 3Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, IndiaBackground: There is no consensus on the role of cortisol in the pathogenesis of obesity and metabolic syndrome (MS. This cross-sectional study aimed to analyze the relationship of morning plasma cortisol and adrenocorticotropic hormone (ACTH levels with body mass index (BMI and glucose tolerance.Subjects and methods: The sample frame was the “Offspring of individuals with diabetes study” database. A total of 358 offspring of individuals with type 2 diabetes mellitus (T2DM and 287 individuals without a known family history of T2DM were recruited for the study. Subjects who were ≥10 years of age were selected from the database for analysis. Subjects with T2DM were excluded. All participants underwent a 75 g oral glucose tolerance test (OGTT, and blood samples were collected at 0, 30, 60, and 120 minutes for glucose, insulin and C-peptide. Plasma cortisol, ACTH, and lipid profile were estimated from the fasting sample.Results: Four hundred and ninety-five participants (305 males [62%] and 190 females [38%] were included in the analysis. ACTH and cortisol levels were higher in normal-weight subjects than in overweight/obese subjects. Both ACTH and cortisol increased as fasting plasma glucose increased. Cortisol levels were significantly lower in offspring of T2DM subjects with MS than in offspring of T2DM subjects without MS. When adjusted for BMI, the significance was marginal. In males, cortisol levels were negatively correlated with early insulin secretion during OGTT (insulinogenic index [0–30] and positively with waist circumference and serum high-density lipoprotein cholesterol. In females, fasting

  7. Lasting effect of an oral hygiene care program for patients with stroke during in-hospital rehabilitation: a randomized single-center clinical trial.

    Science.gov (United States)

    Kim, Eun-Kyong; Park, Eun Young; Sa Gong, Jung-Whan; Jang, Sung-Ho; Choi, Youn-Hee; Lee, Hee-Kyung

    2017-11-01

    Because the oral hygiene is poorly prioritized in the immediate post-stroke period, we implemented an oral hygiene care program (OHCP) for stroke in-patients and evaluated its persistence after discharge. In all, 62 patients with stroke who were admitted to the rehabilitation ward were randomly assigned to two groups: 33 patients to the intervention group and 29 to the control group. The OHCP, including tooth brushing education and professional tooth cleaning, was administered to the intervention group twice a week six times during in-hospital rehabilitation. Oral health status was examined both at baseline and three months after discharge from the hospital. Oral hygiene status was examined at three- to four-day intervals five times during the hospitalization period. After OHCP, oral hygiene status including the plaque index, calculus index, and O'Leary plaque index improved significantly in the intervention group, compared to the control group (p oral health and plaque control performance among patients with stroke, with effects still seen three months after discharge from the hospital. Implications for Rehabilitation Initial oral hygiene status and plaque control performance were poor in stroke patients who were in rehabilitation center. An oral hygiene care program during in-hospital rehabilitation was effective in improving oral hygiene status and plaque control performance among stroke patients at three months after discharge. Repeated tooth brushing education and professional tooth cleaning were necessary to improve plaque control performance of stroke patients.

  8. Albiglutide, a weekly GLP-1 receptor agonist, improves glycemic parameters in Japanese patients with type 2 diabetes over 1 year when added to single oral antidiabetic drugs.

    Science.gov (United States)

    Okuda, Inaha; Wilson, Timothy H; Yue, Lin; Nakajima, Hiromu; Carr, Molly C; Tsuboi, Maho; Nino, Antonio; Seino, Yutaka

    2017-03-01

    To evaluate the safety and efficacy of once weekly albiglutide added to a single oral antidiabetic drug (OAD) in Japanese patients with inadequately controlled type 2 diabetes mellitus (T2DM). In this phase 3, 1 year study (NCT01777282), patients (N = 374) received albiglutide 30 mg plus a single OAD (sulfonylurea [n = 120], biguanide [n = 67)], glinide [n = 65], thiazolidinedione [n = 61], or α-glucosidase inhibitor [n = 61]). Albiglutide could be increased to 50 mg after Week 4, based on glycemic criteria. Primary endpoints were the incidence of adverse events (AEs) and hypoglycemia; secondary endpoints were changes from baseline at Week 52 in HbA 1c and fasting plasma glucose (FPG), proportion of patients achieving HbA 1c ≤7.0%, and withdrawals due to hyperglycemia. On-therapy AEs occurred in 78.6% of patients and serious AEs in 2.1%. Common AEs were nasopharyngitis (32.6%), constipation (7.2%), and diabetic retinopathy (5.3%). No serious AEs occurred more than once or were reported in >1 patient. Hypoglycemia occurred in 6.4% of patients, mostly in the albiglutide + sulfonylurea (14.2%) and the albiglutide + glinide (6.2%) groups. Albiglutide was uptitrated in 53.2% of patients. Mean baseline HbA 1c was 8.1%. Mean decreases from baseline in HbA 1c were observed with the addition of albiglutide to thiazolidinediones (-1.42%), α-glucosidase inhibitors (-1.39%), sulfonylureas (-1.04%), glinides (-0.95%), and biguanides (-0.94%). HbA 1c of 50% of patients and mean reductions in FPG were achieved in all groups. Mean changes from baseline in body weight ranged from +0.52 kg (albiglutide + thiazolidinedione) to -0.33 kg (albiglutide + biguanide). Limitations of the study included open label treatment that was not randomized. When combined with a single OAD in Japanese patients with inadequately controlled T2DM, albiglutide led to favorable changes in all glycemic parameters, with minor changes in body weight

  9. Evaluation of the curative and preventive efficacy of a single oral administration of afoxolaner against cat flea Ctenocephalides felis infestations on dogs.

    Science.gov (United States)

    Hunter, James S; Dumont, Pascal; Chester, Theodore S; Young, David R; Fourie, Josephus J; Larsen, Diane L

    2014-04-02

    The efficacy of orally administered afoxolaner for treatment and prevention of repeated infestations with adult Ctenocephalides felis on dogs was evaluated in two studies after administration of a beef-flavored soft chew. In each study, 32 dogs were divided randomly into four equal groups. Dogs in Groups 1 and 3 were not treated and served as controls. Dogs in Groups 2 and 4 were treated on Day 0 with a combination of chewable tablets to be as close as possible to the minimum therapeutic dose of 2.5mg/kg. All animals were infested experimentally with unfed C. felis (100 ± 5) on Days -1, 7, 14, 21, 28 and 35. Flea killing efficacy was evaluated in both studies while, efficacy against flea egg production was assessed in Study 1. Live fleas were counted at 12 (Groups 1 and 2) and 24h (Groups 3 and 4), after treatment or after weekly infestations. In Study 1, flea eggs were collected and counted at either 12 or 24h after each flea infestation on Days 7, 14, 21, 28 and 35. The results of both studies demonstrate the long lasting and rapid efficacy of afoxolaner against C. felis, when administered as a single oral dose to dogs. For flea counts conducted 24h after treatment or infestation, efficacy was 100% for all time points up to Day 36 in both studies, except for one time point (99.9% on Day 22) for Study 2. For flea counts performed 12h after treatment or infestation, efficacy was ≥ 95.2% until Day 21 in both studies. Efficacy at 12h was ≥ 93.0% on Day 35 in Study 1 and ≥ 89.7% on Day 35 in Study 2. The treated groups had significantly fewer fleas than untreated control dogs in both studies for all flea counts (p=0.003 Study 1, p=0.0006 Study 2). In Study 1, for all egg counts performed at or beyond Day 7, efficacy in egg reduction was >99% for all time points between Days 7 and 35. Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.

  10. Glucocorticoid management in rheumatoid arthritis: morning or night low dose?

    Science.gov (United States)

    Paolino, Sabrina; Cutolo, Maurizio; Pizzorni, Carmen

    2017-01-01

    Morning symptoms of rheumatoid arthritis (RA) are linked to circadian increase of night inflammation, supported by inadequate cortisol secretion in active disease. Therefore, exogenous glucocorticoid administration in RA is recommended by EULAR and ACR from the beginning of the diagnosis, since may partially act like a "replacement therapy". In addition, the prevention/treatment of the night up-regulation of the immune/inflammatory reaction has been shown more effective when exogenous glucocorticoid administration is managed with a night-time-release formulation. Despite a considerably higher cost than conventional prednisone (immediate release), chronotherapy with night-time-release prednisone has been recognized a cost-effective option for RA patients not on glucocorticoids who are eligible for therapy with biologic disease-modifying antirheumatic drugs (DMARDs). Interestingly, since different cell populations involved in the inflammatory process are particularly activated during the night (i.e. monocytes, macrophages), other therapeutical approaches used in RA, such as conventional DMARDs and non-steroidal anti-inflammatory drugs (NSAIDs) should follow the same concepts of glucocorticoid chronotherapy. Therefore, bedtime methotrexate chronotherapy was found to better manage RA symptoms, and several available NSAIDs (i.e. indomethacin, aceclofenac, ketoprofen, flurbiprofen, lornoxicam) have been recently modified in their formulation, in order to obtain more focused night action.

  11. Hello Sunday Morning: Alcohol, (non)consumption and selfhood.

    Science.gov (United States)

    Pennay, Amy; MacLean, Sarah; Rankin, Georgia

    2016-02-01

    Hello Sunday Morning (HSM) is an online program that encourages people to commit to a period of non-drinking and blog about their experiences. The purpose of this paper is to explore how HSM members negotiated their periods of abstention, with a focus on how not drinking influenced their narratives of selfhood. Thematic analysis was undertaken of 2844 blog posts from 154 Victorians who signed up to HSM in 2013 or 2014. Analysis revealed three key narratives of selfhood offered by participants: (1) abstinence resulting in a disrupted sense of self, (2) non-consumption facilitating the development of a new healthy self, and (3) anti-consumption facilitating the development of a resistant self. Individuals construct and maintain their sense of self through consumption (or non-consumption) activities, and this occurs within the broader context of the relationship between selfhood, consumption and culture. HSM members developed narratives of self by drawing on a range of wider discursive structures concerning pleasure, healthism and resistance. The typologies of non-drinking selves identified in this paper could be disseminated through platforms such as HSM to support people who are new to non-drinking in choosing how they might construct and enact alternative selfhoods in contexts where alcohol consumption is deeply embedded. Copyright © 2015 Elsevier B.V. All rights reserved.

  12. Glucocorticoid management in rheumatoid arthritis: morning or night low dose?

    Directory of Open Access Journals (Sweden)

    Sabrina Paolino

    2017-08-01

    Full Text Available Morning symptoms of rheumatoid arthritis (RA are linked to circadian increase of night inflammation, supported by inadequate cortisol secretion in active disease. Therefore, exogenous glucocorticoid administration in RA is recommended by EULAR and ACR from the beginning of the diagnosis, since may partially act like a “replacement therapy”. In addition, the prevention/treatment of the night up-regulation of the immune/inflammatory reaction has been shown more effective when exogenous glucocorticoid administration is managed with a night-time-release formulation. Despite a considerably higher cost than conventional prednisone (immediate release, chronotherapy with night-time-release prednisone has been recognized a cost-effective option for RA patients not on glucocorticoids who are eligible for therapy with biologic disease-modifying antirheumatic drugs (DMARDs. Interestingly, since different cell populations involved in the inflammatory process are particularly activated during the night (i.e. monocytes, macrophages, other therapeutical approaches used in RA, such as conventional DMARDs and non-steroidal anti-inflammatory drugs (NSAIDs should follow the same concepts of glucocorticoid chronotherapy. Therefore, bedtime methotrexate chronotherapy was found to better manage RA symptoms, and several available NSAIDs (i.e. indomethacin, aceclofenac, ketoprofen, flurbiprofen, lornoxicam have been recently modified in their formulation, in order to obtain more focused night action.

  13. Effects of load on good morning kinematics and EMG activity

    Directory of Open Access Journals (Sweden)

    Andrew David Vigotsky

    2015-01-01

    Full Text Available Many strength and conditioning coaches utilize the good morning (GM to strengthen the hamstrings and spinal erectors. However, little research exists on its electromyography (EMG activity and kinematics, and how these variables change as a function of load. The purpose of this investigation was to examine how estimated hamstring length, integrated EMG (IEMG activity of the hamstrings and spinal erectors, and kinematics of the lumbar spine, hip, knee, and ankle are affected by changes in load. Fifteen trained male participants (age = 24.6 ± 5.3 years; body mass = 84.7 ± 11.3 kg; height = 180.9 ± 6.8 cm were recruited for this study. Participants performed five sets of the GM, utilizing 50, 60, 70, 80, and 90% of one-repetition maximum (1RM in a randomized fashion. IEMG activity of hamstrings and spinal erectors tended to increase with load. Knee flexion increased with load on all trials. Estimated hamstring length decreased with load. However, lumbar flexion, hip flexion, and plantar flexion experienced no remarkable changes between trials. These data provide insight as to how changing the load of the GM affects EMG activity, kinematic variables, and estimated hamstring length. Implications for hamstring injury prevention are discussed. More research is needed for further insight as to how load affects EMG activity and kinematics of other exercises.

  14. Physiological changes, sleep, and morning mood in an isolated environment

    Science.gov (United States)

    Kraft, Norbert O.; Inoue, Natsuhiko; Mizuno, Koh; Ohshima, Hiroshi; Murai, Tadashi; Sekiguchi, Chiharu; Orasanu, J. M. (Principal Investigator)

    2002-01-01

    BACKGROUND: Previous isolation studies have shown increased 24-h urine volumes and body weight gains in subjects. This project examined those and other physiological variables in relationship to sleep motor activity, subjective sleep quality, mood, and complaints during confinement. METHODS: Six male and two female subjects lived for 7 d in the National Space Development Agency of Japan's isolation chamber, which simulates the interior of the Japanese Experiment Module. Each 24-h period included 6 h of sleep, 3 meals, and 20 min of exercise. Each morning, subjects completed Sleep Sensation and Complaint Index questionnaires. Catecholamine and creatinine excretion, urine volume, and body weight were measured on the 2 d before and 2 d after confinement, and sleep motor activity was measured during confinement. RESULTS: Confinement produced no significant change in body weight, urine volume, or questionnaire results. In contrast, epinephrine, norepinephrine, and sleep motor activity exhibited significant differences during confinement (p sleep motor activity. CONCLUSION: The 24-h epinephrine values were slightly higher than normal throughout the experiment, but lower than for subjects working under time-stress. High sympathetic activity (as indicated by norepinephrine) may have interfered with sleep.

  15. [The morning report - an important item in the training of psychiatrists in residence at psychiatric hospitals].

    Science.gov (United States)

    Con, D; Goethals, K

    2015-01-01

    In this article we focus on the role, function and composition of the morning report in the training of psychiatrists in residence at psychiatric hospitals. We also pay attention to the way in which the case should be presented in the morning report. To make some proposals regarding ways in which the efficiency of the morning report and the case presented in that report can be improved. We studied currently available literature and publications about the morning report and we also drew on our own experience with the morning report. We found very few publications that dealt specifically with morning report in the psychiatric teaching hospital. However, our studies have shown that the morning report should not be regarded purely as an instrument for passing on care details about the patient; it should also be seen as an essential link in the chain of instruction required by trainee psychiatrist. On the basis of rhetoric, constructivism and social-constructionism, we present a model for case presentation. Making improvements in the quality of the morning report is an important way of contributing to the learning process of trainee psychiatrists and staff members and should therefore enhance the status of the psychiatric hospital as a teaching community.

  16. Association between sleep disorders and morning blood pressure in hypertensive patients.

    Science.gov (United States)

    Li, Xinran; Li, Jiangbo; Liu, Kai; Gong, Shenzhen; Shi, Rufeng; Pan, Pei; Yang, Yujie; Chen, Xiaoping

    2018-01-01

    Sleep disorders are known to increase the risk of hypertension, yet few studies have investigated the relation between sleep disorders and morning blood pressure (BP). This study aimed to determine, whether the morning BP is associated with sleep quality and sleep-disordered breathing. A total of 144 hypertensive patients were included in this cross-sectional study. Each subject underwent anthropometric measurements, biochemical testing, 24-h ambulatory BP monitoring, and polysomnography (PSG). Sleep quality and sleep-disordered breathing were determined by PSG parameters of sleep architecture and sleep respiratory. There were no significant differences between subjects with and without morning hypertension in the parameters of sleep architecture and sleep respiratory. In multiple regression analysis, morning BP was independently associated with night-time BP and morning BP surge, but not with the parameters of sleep architecture and sleep respiratory. Further analysis showed that both night-time BP and morning BP surge were independently associated with the sleep respiratory parameters. In conclusion, sleep-disordered breathing might indirectly affect the morning BP by elevated night-time BP, yet neither poor sleep quality nor sleep-disordered breathing was major determinants of elevated morning BP in hypertensive patients.

  17. Solar flux variation of the electron temperature morning overshoot in the equatorial F region

    DEFF Research Database (Denmark)

    Stolle, Claudia; Liu, H.; Truhlik, V.

    2011-01-01

    Using 8 years of CHAMP satellite observations of the equatorial electron temperature, T-e, we investigate its behavior during the morning overshoot and at ionospheric altitudes below 450 km including its variation with solar activity. The morning T-e has a maximum at the dip equator and decreases...

  18. "Like Being at the Breakfast Table": The Power of Classroom Morning Meeting.

    Science.gov (United States)

    Bondy, Elizabeth; Ketts, Sharon

    2001-01-01

    Describes one teacher's inclusion of the Morning Meeting concept in her third-grade classroom and relates student success in standardized testing to its implementation. Provides detailed information on Morning Meeting including its structure, rationale, and influence; includes an argument for immediate implementation. Concludes by asserting that…

  19. Gaming the System: Creation of a Random Case-Generating Game for Use in Morning Report.

    Science.gov (United States)

    Kamra, Pallavi; Borman-Shoap, Emily C; Zhang, Lei; Pitt, Michael B

    2018-03-01

    Discussing real-world cases with known outcomes is a common feature of resident morning report. We present a novel case-generating game that allows for creative, dynamic problem-solving discussions and appears to encourage more peer-directed learning than traditional morning report. Copyright © 2017 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

  20. Effect of active warm-up duration on morning short-term maximal ...

    African Journals Online (AJOL)

    In addition, ratings of perceived exertion were higher after the 15-min warm-up than the 5-min warm-up only during Ramadan. Conclusions: There is no need to prolong the warm-up period before short-term maximal exercise performed during Ramadan in the morning. Keywords: fasting; morning; warm-up; anaerobic; ...

  1. One night of sleep restriction following heavy exercise impairs 3-km cycling time-trial performance in the morning.

    Science.gov (United States)

    Chase, John D; Roberson, Paul A; Saunders, Michael J; Hargens, Trent A; Womack, Christopher J; Luden, Nicholas D

    2017-09-01

    The goal of this project was to examine the influence of a single night of sleep restriction following heavy exercise on cycling time-trial (TT) performance and skeletal muscle function in the morning. Seven recreational cyclists (age, 24 ± 7 years; peak oxygen consumption, 62 ± 4 mL·kg -1 ·min -1 ) completed 2 phases, each comprising evening (EX1) and next-morning (EX2) exercise sessions. EX1 and EX2 were separated by an assigned sleep condition: a full night of rest (CON; 7.1 ± 0.3 h of sleep) or sleep restriction through early waking (SR; 2.4 ± 0.2 h). EX1 comprised baseline testing (muscle soreness, isokinetic torque, and 3-km TT performance) followed by heavy exercise that included 60 min of high-intensity cycling intervals and resistance exercise. EX2 was performed to assess recovery from EX1 and included all baseline measures. Magnitude-based inferences were used to evaluate all variables. SR had a negative effect (very likely) on the change in 3-km TT performance compared with CON. Specifically, 3-km TT performance was 'very likely' slower during EX2 compared with EX1 following SR (-4.0% ± 3.0%), whereas 3-km TT performance was 'possibly' slower during EX2 (vs. EX1) following CON (-0.5% ± 3.0%). Sleep condition did not influence changes in peak torque or muscle soreness from EX1 to EX2. A single night of sleep restriction following heavy exercise had marked consequences on 3-km TT performance the next morning. Because occasional sleep loss is likely, strategies to ameliorate the consequences of sleep loss on performance should be investigated.

  2. Pre-operative oral nutritional supplementation with dietary advice versus dietary advice alone in weight-losing patients with colorectal cancer: single-blind randomized controlled trial.

    Science.gov (United States)

    Burden, Sorrel T; Gibson, Debra J; Lal, Simon; Hill, James; Pilling, Mark; Soop, Mattias; Ramesh, Aswatha; Todd, Chris

    2017-06-01

    Pre-operative weight loss has been consistently associated with increased post-operative morbidity. The study aims to determine if pre-operative oral nutritional supplements (ONSs) with dietary advice reduce post-operative complications. Single-blinded randomized controlled trial. People with colorectal cancer scheduled for surgery with pre-operative weight loss >1 kg/3-6 months were randomized by using stratified blocks (1:1 ratio) in six hospitals (1 November 2013-28 February 2015). Intervention group was given 250 mL/day ONS (10.1 KJ and 0.096 g protein per mL) and dietary advice. Control group received dietary advice alone. Oral nutritional supplements were administered from diagnosis to the day preceding surgery. Research team was masked to group allocation. Primary outcome was patients with one or more surgical site infection (SSI) or chest infection; secondary outcomes included percentage weight loss, total complications, and body composition measurements. Intention-to-treat analysis was performed with both unadjusted and adjusted analyses. A sample size of 88 was required. Of 101 participants, (55 ONS, 46 controls) 97 had surgery. In intention-to-treat analysis, there were 21/45 (47%) patients with an infection-either an SSI or chest infection in the control group vs. 17/55 (30%) in the ONS group. The odds ratio of a patient incurring either an SSI or chest infection was 0.532 (P = 0.135 confidence interval 0.232 to 1.218) in the unadjusted analysis and when adjusted for random differences at baseline (age, gender, percentage weight loss, and cancer staging) was 0.341 (P = 0.031, confidence interval 0.128 to 0.909). Pre-operative percentage weight loss at the first time point after randomization was 4.1% [interquartile range (IQR) 1.7-7.0] in ONS group vs. 6.7% (IQR 2.6-10.8) in controls (Mann-Whitney U P = 0.021) and post-operatively was 7.4% (IQR 4.3-10.0) in ONS group vs. 10.2% (IQR 5.1-18.5) in controls (P = 0.016). Compared

  3. Relative bioavailability of single doses of prolonged-release tacrolimus administered as a suspension, orally or via a nasogastric tube, compared with intact capsules: a phase 1 study in healthy participants.

    Science.gov (United States)

    Undre, Nasrullah; Dickinson, James

    2017-04-04

    Tacrolimus, an immunosuppressant widely used in solid organ transplantation, is available as a prolonged-release capsule for once-daily oral administration. In the immediate postsurgical period, if patients cannot take intact capsules orally, tacrolimus therapy is often initiated as a suspension of the capsule contents, delivered orally or via a nasogastric tube. This study evaluated the relative bioavailability of prolonged-release tacrolimus suspension versus intact capsules in healthy participants. A phase 1, open-label, single-dose, cross-over study. A single clinical research unit. In total, 20 male participants, 18-55 years old, entered and completed the study. All participants received nasogastric administration of tacrolimus 10 mg suspension in treatment period 1, with randomisation to oral administration of suspension or intact capsules in periods 2 and 3. Blood concentration-time profile over 144 hours was used to estimate pharmacokinetic parameters. Primary end point: relative bioavailability of prolonged-release intact capsule versus oral or nasogastric administration of prolonged-release tacrolimus suspension (area under the concentration-time curve (AUC) from time 0 to infinity post-tacrolimus dose (AUC 0-∞ ); AUC measured until the last quantifiable concentration (AUC 0-tz ); maximum observed concentration (C max ); time to C max (T max )). Tolerability was assessed throughout the study. Relative bioavailability of prolonged-release tacrolimus suspension administered orally was similar to intact capsules, with a ratio of least-square means for AUC 0-tz and AUC 0-∞ of 1.05 (90% CI 0.96 to 1.14). Bioavailability was lower with suspension administered via a nasogastric tube versus intact capsules (17%; ratio 0.83; CI 0.76 to 0.92). C max was higher for oral and nasogastric suspension (30% and 28%, respectively), and median T max was shorter (difference 1.0 and 1.5 hours postdose, respectively) versus intact capsules (2.0 hours). Single 10

  4. Ethnic differences in sleep duration and morning-evening type in a population sample.

    Science.gov (United States)

    Malone, Susan Kohl; Patterson, Freda; Lu, Yinghui; Lozano, Alicia; Hanlon, Alexandra

    2016-01-01

    This cross-sectional population study examined associations of sleep duration and morning-evening type with sociodemographic and cardiometabolic disease in adults participating in the UK Biobank study (N = 439 933). Multivariable Poisson regression models of sleep duration and morning-evening type with a robust error variance were generated to estimate adjusted prevalence ratios and their 95% confidence intervals. All models were adjusted for sex, race, college attendance, employment status and age. Twenty five percent of the sample reported short sleep; 27% were morning, 64% intermediate and 9% evening type. Black ethnicity emerged as most strongly associated with sleep behavior. Short sleep was twice as prevalent, and morning versus intermediate type was 1.4 times more prevalent in Black than White participants. The greater prevalence of short sleep and morning type among Blacks suggests that sleep-based approaches to improving cardiometabolic outcomes may require a more multidimensional approach that encompasses adequate sleep and circadian alignment in this population.

  5. Patterns of Morning and Evening Fatigue Among Adults with HIV/AIDS

    Science.gov (United States)

    Lerdal, Anners; Gay, Caryl L.; Aouizerat, Bradley E.; Portillo, Carmen J.; Lee, Kathryn A.

    2011-01-01

    Aims and objectives Describe patterns of morning and evening fatigue in adults with HIV and examine their relationship to demographic and clinical factors and other symptoms. Background Most studies of HIV-related fatigue assess average levels of fatigue and do not address its diurnal fluctuations. Patterns of fatigue over the course of the day may have important implications for assessment and treatment. Design A cross-sectional, correlational design was used with six repeated measures over 72 hours. Method A convenience sample of 318 HIV-infected adults was recruited in San Francisco. Socio-demographic, clinical and symptom data were collected with questionnaires. CD4+ T-cell count and viral load were obtained from medical records. Participants completed a four-item version of the Lee Fatigue Scale each morning and evening for three consecutive days. Participants were grouped based on their diurnal pattern of fatigue (high evening only, high morning only, high morning and evening and low morning and evening). Group comparisons and logistic regression were used to determine the unique predictors of each fatigue pattern. Results The high evening fatigue pattern was associated with anxiety and the high morning pattern was associated with anxiety and depression. The morning fatigue pattern showed very little fluctuation between morning and evening, the evening pattern showed the largest fluctuation. The high morning and evening pattern was associated with anxiety, depression and sleep disturbance and this group reported the most fatigue-related distress and interference in functioning. Conclusions These results provide initial evidence for the importance of assessing the patient’s daily pattern of fatigue fluctuation, as different patterns were associated with different symptom experiences and perhaps different etiologies. Relevance to clinical practice Different fatigue patterns may benefit from tailored intervention strategies. Management of depressive symptoms

  6. Exposure of fatty acids after a single oral administration of sacha inchi (Plukenetia volubilis L.) and sunflower oil in human adult subjects.

    Science.gov (United States)

    Gonzales, Gustavo F; Gonzales, Carla; Villegas, Leon

    2014-01-01

    Sacha inchi (Plukenetia volubilis L.) is a potential oilseed crop because it is rich in α-linolenic acid (ALA) (omega-3 fatty acid). To evaluate the exposure of fatty acids after a single oral administration of sacha inchi or sunflower oil in healthy volunteers. Plasma fatty acids concentrations were assayed by Gas Chromatography with Flame Ionization Detector in 18 adult subjects. After fasting, blood samples were obtained at 0, 0.5, 1, 2, 4, 8 and 24 h after ingestion of 10 or 15 ml of sacha inchi oil or sunflower oil. The proportion ALA/linoleic acid was 1.37 in sacha inchi oil and 0.01 in sunflower oil. ALA, lauric acid, palmitic acid, linolelaidic acid, cis-8,11,14-eicosatrienoic acid, cis-13,16-docosadienoic acid and cis-4,7,10,13,16,19-docosahexaenoic acid (DHA) levels changed over time after sacha inchi oil ingestion but not with sunflower oil. The time at maximal concentration (tmax) for ALA was 2 h after sacha inchi oil ingestion. No ALA in plasma was observed after sunflower oil consumption. The maximal concentration of ALA was 2.84 ± 0.36 mg/ml in women and 0.94 ± 0.57 mg/ml in men, p  0.05). There is a trend for higher plasma ALA levels with 15 ml sacha inchi oil. After 2 h of consumption, plasma delta triacylglycerol were reduced with sunflower oil but slightly increased with sacha inchi oil. A reduction in plasma delta triacylglycerol-rich lipoprotein cholesterol was observed with both oils. Consumption of sacha inchi oil increased ALA and DHA in plasma.

  7. Triple Antithrombotic Therapy after Percutaneous Coronary Intervention (PCI in Patients with Indication for Oral Anticoagulation: Data from a Single Center Registry.

    Directory of Open Access Journals (Sweden)

    Dawid L Staudacher

    Full Text Available Antithrombotic therapy consisting of a dual anti-platelet therapy (DAPT and oral anti-coagulation (OAC with a vitamin k antagonist is often referred to as triple therapy. This combined anticoagulation is applied in patients undergoing coronary artery stent implantation while also having an indication for OAC. Triple therapy increases the risk for bleeding events compared to either DAPT or OAC alone and thereby might be associated with adverse outcomes. Clinical data on the frequency of bleeding events in patients on triple therapy from clinical trials derives from pre-selected patients and may differ from the real world patients. We report data on patient characteristics and bleeding incidence of patients dismissed on triple therapy from a single university hospital. Within the time span from January 2000 to December 2012, we identified a total of 213 patients undergoing PCI who were prescribed a triple therapy for at least 4 weeks (representing 0.86% of all patients treated. The usage of triple therapy significantly increased over the observed time period. The average CHA2DS2-VASc Score was 3.1 ± 1.1 with an average HAS-BLED score of 2.5 ± 0.86 representing a high-risk group for thromboembolic events as well as considerable risk for bleeding events. An on-treatment bleeding incidence of 9.4% was detected, with gastrointestinal and airway bleeding being the most frequent (5.1% and 1.4%, respectively. This is consistent with data from clinical trials and confirms the high risk of bleeding in patients on DAPT plus OAC. 29.0% of all patients receiving triple therapy had an indication for OAC other than non-valvular atrial fibrillation. This substantial patient group is underrepresented by clinical trials and needs further attention.

  8. 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.

    Directory of Open Access Journals (Sweden)

    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.

  9. Concentrations of levofloxacin (HR 355) in the respiratory tract following a single oral dose in patients undergoing fibre-optic bronchoscopy.

    Science.gov (United States)

    Andrews, J M; Honeybourne, D; Jevons, G; Brenwald, N P; Cunningham, B; Wise, R

    1997-10-01

    Concentrations of levofloxacin were measured in bronchial biopsies, alveolar macrophages (AM), epithelial lining fluid (ELF) and serum following a single oral dose. Concentrations were measured by a microbiological assay method. A total of 35 patients undergoing fibre-optic bronchoscopy were studied. Mean serum, AM, ELF and biopsy concentrations were as follows. 0.5 h: 4.73 mg/L, 19.1 mg/L, 4.74 mg/L and 4.3 mg/kg; 1 h: 6.6 mg/L, 32.5 mg/L, 10.8 mg/L and 8.3 mg/kg; 2 h: 4.9 mg/L, 41.9 mg/L, 9.0 mg/L and 6.5 mg/kg; 4 h: 4.1 mg/L, 27.7 mg/L, 10.9 mg/L and 6.0 mg/kg; and 6-8 h: 4.0 mg/L, 38.4 mg/L, 9.6 mg/L and 4.0 mg/kg respectively. Mean serum and AM concentrations at 12-24 h were 1.2 and 13.9 mg/L respectively (concentrations in biopsy and ELF were only measurable in three of the six patients). These concentrations exceed the MIC90s of the common respiratory pathogens, Haemophilus influenzae (0.015 mg/L), Moraxella catarrhalis (0.06 mg/L) and Streptococcus pneumoniae (1 mg/L) and suggest that levofloxacin should be efficacious in the treatment of community- and hospital-acquired respiratory infection.

  10. Stability in the rumen and effect on plasma status of single oral doses of vitamin D and vitamin E in high-yielding dairy cows.

    Science.gov (United States)

    Hymøller, L; Jensen, S K

    2010-12-01

    lower effect on plasma status of ergocalciferol than of cholecalciferol, and an even lower effect of α-tocopherol. The limited plasma response after a single dose of α-tocopheryl acetate led to the conclusion that oral single dose therapy with all-rac-α-tocopheryl acetate is of limited physiological value. Copyright © 2010 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

  11. Randomized, Single-Blind, Parallel Clinical Trial on Efficacy of Oral Prednisolone Versus Intramuscular Corticotropin on Immediate and Continued Spasm Control in West Syndrome.

    Science.gov (United States)

    Wanigasinghe, Jithangi; Arambepola, Carukshi; Sri Ranganathan, Shalini; Sumanasena, Samanmalie; Attanapola, Gangani

    2015-09-01

    A single-center, single-blind, parallel-group, randomized clinical trial was performed to test the null hypothesis that adrenocorticotropic hormone is not superior to high-dose prednisolone for treatment of newly diagnosed West syndrome. Newly diagnosed infants with West syndrome were randomized to receive 14 days of oral prednisolone (40-60 mg/day) or a synthetically prepared intramuscular long-acting adrenocorticotropic hormone (40-60 IU/every other day [0.5-0.75 mg]) according to the United Kingdom Infantile Spasm Study protocol. They were blindly evaluated for infantile spasm remission by day 14, electroclinical remission (spasm cessation + resolution of hypsarrhythmia on a 30-minute electroencephalograph) by day 14 and continued spasm freedom for 28 days. Ninety-seven patients were enrolled in the study, with 48 of them receiving prednisolone and 49 receiving ACTH. There was no significant difference in the baseline characteristics or risk factors for the two treatment groups. By day 14, cessation of infantile spasms occurred in 28/48 (58.3%) infants on prednisolone compared with only 18/49 (36.7%) infants given adrenocorticotropic hormone (P = 0.03) and electroclinical remission in 21 on prednisolone compared with nine on adrenocorticotropic hormone (P = 0.007). Sustained spasm control for 28 consecutive days following electroclinical remission occurred in 15 children on prednisolone compared with six on adrenocorticotropic hormone (P = 0.008). The total number of days required for spasm cessation was significantly less in those treated with prednisolone (3.85 days ± 2.4) compared with adrenocorticotropic hormone (8.65 days ± 3.7) (P = 0.001). Among patients who did not achieve remission, there was a non-significant trend toward greater quantitative reduction of spasms with prednisolone than with adrenocorticotropic hormone (P = 0.079). Synthetic adrenocorticotropic hormone of 40-60 IU/every other day did not yield superior rates of electroencephalographic

  12. Fears of violence during morning travel to school.

    Science.gov (United States)

    Wiebe, Douglas J; Guo, Wensheng; Allison, Paul D; Anderson, Elijah; Richmond, Therese S; Branas, Charles C

    2013-07-01

    Children's safety as they travel to school is a concern nationwide. We investigated how safe children felt from the risk of being assaulted during morning travel to school. Children between 10 and 18 years old were recruited in Philadelphia and interviewed with the aid of geographic information system (GIS) mapping software about a recent trip to school, situational characteristics, and how safe they felt as they travelled based on a 10-point item (1 = very unsafe, 10 = very safe). Ordinal regression was used to estimate the probability of perceiving different levels of safety based on transportation mode, companion type, and neighborhood characteristics. Among 65 randomly selected subjects, routes to school ranged from 7 to 177 minutes (median = 36) and .1-15.1 street miles (median = 1.9), and included between 1-5 transportation modes (median = 2). Among students interviewed, 58.5% felt less than very safe (i.e., school and one-third (32.5%) of the total person time was spent feeling less than very safe. Nearly a quarter of students, or 24.6%, felt a reduction in safety immediately upon exiting their home. The probability of reporting a safety of >8, for example, was .99 while in a car and .94 while on foot but was .86 and .87 when on a public bus or trolley. Probability was .98 while with an adult but was .72 while with another child and .71 when alone. Also, perceived safety was lower in areas of high crime and high density of off-premise alcohol outlets. Efforts that target situational risk factors are warranted to help children feel safe over their entire travel routes to school. Copyright © 2013 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  13. Bioavailability of two single-dose oral formulations of omeprazole 20 mg: an open-label, randomized sequence, two-period crossover comparison in healthy Mexican adult volunteers.

    Science.gov (United States)

    Poo, Jorge Luis; Galán, Juan Francisco; Rosete, Alejandra; de Lago, Alberto; Oliva, Iván; González-de la Parra, Mario; Jiménez, Patricia; Burke-Fraga, Victoria; Namur, Salvador

    2008-04-01

    Omeprazole is a proton-pump inhibitor that acts to reduce acid secretion in the stomach and is used for treating various acid-related gastrointestinal disorders. There are several generic formulations of omeprazole available in Mexico; however, a literature search failed to identify published data concerning the bioavailability of these formulations in the Mexican population. The aim of this study was to compare the bioavailability of 2 oral formulations of omeprazole 20-mg capsules, marketed for use in Mexico, in healthy volunteers: Inhibitron (test formulation) and LosecA 20 mg (reference formulation). This study used a single-dose, open-label, randomized sequence, 2 x 2 crossover (2 administration periods x 2 treatments) design to compare the 2 formulations. Eligible subjects were healthy adult Mexican volunteers of both sexes. Subjects were randomly assigned in a 1:1 ratio to receive a single 20-mg dose of the test formulation followed by the reference formulation, or vice versa, with a 7-day washout period between administration periods. After a 12-hour (overnight) fast, subjects received a single, 20-mg dose of the corresponding formulation. Plasma samples were obtained over a 12-hour period after administration. Plasma omeprazole concentrations were analyzed by a nonstereospecific high-performance liquid chromatography method. For analysis of pharmacokinetic properties, including C(max), AUC from time 0 (baseline) to time t (AUC(0-t)), and AUC from baseline to infinity (AUC(0-infinity)), blood samples were drawn at baseline and 0.17, 0.33, 0.50, 0.75, 1, 1.25, 1.50, 1.75, 2, 2.50, 3, 4, 6, 8, and 12 hours after administration. The formulations were considered bioequivalent if the natural log (ln)-transformed ratios of C(max) and AUC were within the predetermined equivalence range of 80% to 125%, and if P disability, or required intervention to prevent permanent impairment or damage. Thirty-four subjects were enrolled and completed the study (25 men and 9

  14. Oral Cancer

    Science.gov (United States)

    Oral cancer can form in any part of the mouth. Most oral cancers begin in the flat cells that cover the ... your mouth, tongue, and lips. Anyone can get oral cancer, but the risk is higher if you are ...

  15. Evening typology and morning tiredness associates with low leisure time physical activity and high sitting.

    Science.gov (United States)

    Wennman, Heini; Kronholm, Erkki; Partonen, Timo; Peltonen, Markku; Vasankari, Tommi; Borodulin, Katja

    2015-01-01

    Circadian typology is a latent trait that is usually assessed with scoring on a series of questions thought to represent the construct. But, in the classification, most people fall into the intermediate type, i.e. neither a definite morning nor an evening type, but still showing stronger preference towards either end of the continuum. Our aim was to operationalize chronotype using latent class analysis (LCA) for a 6-item scale derived from the original Horne-Östberg Morningness-Eveningness Questionnaire to compare and understand characteristics of chronotype in a population-based sample of adults in Finland. A total of 4904 men and women aged 25-74 years were included. We also analyzed the associations of chronotypes with physical activity (PA) and sitting. We found five latent chronotype groups including "rested more-evening type" (28%), "rested more-morning type" (24%), "morning type" (23%), "tired more-evening type" (17%) and "evening type" (8%) groups. Operationalization of chronotype by LCA suggests that morning alertness is an important feature differentiating chronotypes. Further, the "evening type" and the "tired, more-evening type" had higher odds for none to very low as well as low PA, as compared to "morning type". In addition, "evening type" was associated with higher odds for more time spent sitting, as compared to "morning type". Our findings indicate that it is important to assess sleep schedules and morning tiredness, which then could be targeted as a potential mediating factor for health behaviors, in particular, PA and health status.

  16. Effect of exenatide on the pharmacokinetics of a combination oral contraceptive in healthy women: an open-label, randomised, crossover trial.

    Science.gov (United States)

    Kothare, Prajakti A; Seger, Mary E; Northrup, Justin; Mace, Kenneth; Mitchell, Malcolm I; Linnebjerg, Helle

    2012-03-19

    Consistent with its effect on gastric emptying, exenatide, an injectable treatment for type 2 diabetes, may slow the absorption rate of concomitantly administered oral drugs resulting in a decrease in maximum concentration (Cmax). This study evaluated the drug interaction potential of exenatide when administered adjunctively with oral contraceptives, given their potential concomitant use. This trial evaluated the effect of exenatide co-administration on single- and multiple-dose pharmacokinetics of a combination oral contraceptive (ethinyl estradiol [EE] 30 μg, levonorgestrel [LV] 150 μg [Microgynon 30®]). Thirty-two healthy female subjects participated in an open-label, randomised, crossover trial with 3 treatment periods (oral contraceptive alone, 1 hour before exenatide, 30 minutes after exenatide). Subjects received a single dose of oral contraceptive on Day 8 of each period and QD doses on Days 10 through 28. During treatment periods of concomitant usage, exenatide was administered subcutaneously prior to morning and evening meals at 5 μg BID from Days 1 through 4 and at 10 μg BID from Days 5 through 22. Single- (Day 8) and multiple-dose (Day 22) pharmacokinetic profiles were assessed for each treatment period. Exenatide did not alter the bioavailability nor decrease daily trough concentrations for either oral contraceptive component. No substantive changes in oral contraceptive pharmacokinetics occurred when oral contraceptive was administered 1 hour before exenatide. Single-dose oral contraceptive administration 30 minutes after exenatide resulted in mean (90% CI) Cmax reductions of 46% (42-51%) and 41% (35-47%) for EE and LV, respectively. Repeated daily oral contraceptive administration 30 minutes after exenatide resulted in Cmax reductions of 45% (40-50%) and 27% (21-33%) for EE and LV, respectively. Peak oral contraceptive concentrations were delayed approximately 3 to 4 hours. Mild-to-moderate nausea and vomiting were the most common adverse events

  17. Subgroups of chemotherapy patients with distinct morning and evening fatigue trajectories.

    Science.gov (United States)

    Kober, Kord M; Cooper, Bruce A; Paul, Steven M; Dunn, Laura B; Levine, Jon D; Wright, Fay; Hammer, Marilyn J; Mastick, Judy; Venook, Alan; Aouizerat, Bradley E; Miaskowski, Christine

    2016-04-01

    Purposes of this study were to identify subgroups of patients with distinct trajectories for morning and evening fatigue, evaluate for differences in demographic and clinical characteristics among these subgroups, and compare and contrast the predictors of subgroup membership for morning and evening fatigue. Outpatients with breast, gastrointestinal, gynecological, or lung cancer (n = 582) completed questionnaires, a total of six times over two cycles of chemotherapy (CTX). Morning and evening fatigue severity were evaluated using the Lee Fatigue Scale. Latent profile analysis (LPA) was used to identify distinct subgroups. Three latent classes were identified for morning fatigue (i.e., low (31.8 %), high (51.4 %), and very high (16.8 %)) and for evening fatigue (i.e., moderate (20.0 %), high (21.8 %), and very high (58.2 %)). Most of the disease and treatment characteristics did not distinguish among the morning and evening fatigue classes. Compared to the low class, patients in the high and very high morning fatigue classes were younger, had a lower functional status, and higher level of comorbidity. Compared to the moderate class, patients in the very high evening fatigue class were younger, more likely to be female, had child care responsibilities, had a lower functional status, and a higher level of comorbidity. LPA allows for the identification of risk factors for more severe fatigue. Since an overlap was not observed across the morning and evening fatigue classes and unique predictors for morning and evening fatigue were identified, these findings suggest that morning and evening fatigue may have distinct underlying mechanisms.

  18. Outcomes and prognostic factors for squamous cell carcinoma of the oral tongue in young adults: a single-institution case-matched analysis.

    Science.gov (United States)

    Blanchard, Pierre; Belkhir, Farid; Temam, Stéphane; El Khoury, Clément; De Felice, Francesca; Casiraghi, Odile; Patrikidou, Anna; Mirghani, Haitham; Levy, Antonin; Even, Caroline; Gorphe, Philippe; Nguyen, France; Janot, François; Tao, Yungan

    2017-03-01

    There is controversy regarding prognosis and treatment of young patients with oral cavity cancer compared to their older counterparts. We conducted a retrospective case-matched analysis of all adult patients younger than 40 years and treated at our institution for a squamous cell carcinoma of the oral cavity. Only non-metastatic adult patients (age >18) with oral tongue cancer were eventually included and matched 1:1 with patients over 40 years of age, at least 20 years older than the cases, with same T and N category and treatment period. Sixty-three patients younger than 40 had an oral cavity squamous cell cancer out of which 57 had an oral tongue primary during the period 1999-2012, and 50 could be matched with an older control. No difference could be seen between younger and older patients with regard to overall, cancer-specific, or progression-free survival. The patterns of failure were similar, although in young patients, almost all failures occurred during the first 2 years following treatment. Although overall survival shows a trend toward lower survival in older patients, cancer-specific survival and analysis of pattern failure suggest that disease prognosis is similar between young and older adults with oral tongue cancer. Further work is needed to identify the younger patients with poorer prognosis who overwhelmingly fail during the first year after treatment and could benefit from treatment intensification. Until then, young adults ought to be treated using standard guidelines.

  19. Magnitude of Morning Surge in Blood Pressure Is Associated with Sympathetic but Not Cardiac Baroreflex Sensitivity.

    Science.gov (United States)

    Johnson, Aaron W; Hissen, Sarah L; Macefield, Vaughan G; Brown, Rachael; Taylor, Chloe E

    2016-01-01

    The ability of the arterial baroreflex to regulate blood pressure may influence the magnitude of the morning surge in blood pressure (MSBP). The aim was to investigate the relationships between sympathetic and cardiac baroreflex sensitivity (BRS) and the morning surge. Twenty-four hour ambulatory blood pressure was recorded in 14 young individuals. The morning surge was defined via the pre-awakening method, which is calculated as the difference between mean blood pressure values 2 h before and 2 h after rising from sleep. The mean systolic morning surge, diastolic morning surge, and morning surge in mean arterial pressures were 15 ± 2, 13 ± 1, and 11 ± 1 mmHg, respectively. During the laboratory protocol, continuous measurements of blood pressure, heart rate, and muscle sympathetic nerve activity (MSNA) were made over a 10-min period of rest. Sympathetic BRS was quantified by plotting MSNA burst incidence against diastolic pressure (sympathetic BRSinc), and by plotting total MSNA against diastolic pressure (sympathetic BRStotal). Cardiac BRS was quantified using the sequence method. The mean values for sympathetic BRSinc, sympathetic BRStotal and cardiac BRS were -1.26 ± 0.26 bursts/100 hb/mmHg, -1.60 ± 0.37 AU/beat/mmHg, and 13.1 ± 1.5 ms/mmHg respectively. Significant relationships were identified between sympathetic BRSinc and the diastolic morning surge (r = 0.62, p = 0.02) and the morning surge in mean arterial pressure (r = 0.57, p = 0.03). Low sympathetic BRS was associated with a larger morning surge in mean arterial and diastolic blood pressure. Trends for relationships were identified between sympathetic BRStotal and the diastolic morning surge (r = 0.52, p = 0.066) and the morning surge in mean arterial pressure (r = 0.48, p = 0.095) but these did not reach significance. There were no significant relationships between cardiac BRS and the morning surge. These findings indicate that the ability of the baroreflex to buffer increases in blood pressure

  20. Morning Home Blood Pressure Is a Strong Predictor of Coronary Artery Disease: The HONEST Study.

    Science.gov (United States)

    Kario, Kazuomi; Saito, Ikuo; Kushiro, Toshio; Teramukai, Satoshi; Tomono, Yasuhiro; Okuda, Yasuyuki; Shimada, Kazuyuki

    2016-04-05

    Few studies have evaluated out-of-office blood pressure (BP) measurements as predictors of coronary artery disease (CAD) events. The aim of this study was to determine morning home blood pressure (HBP) as a predictor of CAD events. Using data from the HONEST (Home blood pressure measurement with Olmesartan Naive patients to Establish Standard Target blood pressure) study, we investigated the relationship between morning HBP and incidence of stroke and CAD events. In 21,591 treated hypertensive patients (mean age 64.9 years; mean follow-up 2.02 years), 127 stroke events (2.92 per 1,000 patient-years), and 121 CAD events (2.78 per 1,000 patient-years) occurred. The incidence of stroke events was significantly higher in patients with morning home systolic blood pressure (HSBP) ≥145 mm Hg compared with morning HSBP ≥155 mm Hg and those with morning HSBP morning HSBP predicted stroke events similarly to CSBP. Incidence of CAD events was significantly higher in patients with morning HSBP ≥145 mm Hg compared with morning HSBP ≥155 mm Hg was 6.24 (95% CI: 2.82 to 13.84) and for CSBP ≥160 mm Hg was 3.51 (95% CI: 1.71 to 7.20); therefore, compared with morning HSBP, CSBP may underestimate CAD risk. Goodness-of-fit analysis showed that morning HSBP predicted CAD events more strongly than CSBP. Morning HBP is a strong predictor of future CAD and stroke events, and may be superior to clinic BP in this regard. There does not appear to be a J-curve in the relationship between morning HBP and stroke or CAD events. (Home blood pressure measurement with Olmesartan Naive patients to Establish Standard Target blood pressure Study [HONEST]; UMIN000002567). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  1. Įkalinimas Jean Rhys romane „Good Morning, Midnight“

    OpenAIRE

    Kuncevičiūtė, Karolina

    2016-01-01

    Imprisonment in Jean Rhys's Novel “Good Morning, Midnight” Nowadays, when women are actively fighting for their rights and becoming more independent, women’s literature is very important because it reveals many significant aspects about woman’s position in the male-dominated society. This BA paper analyzes the novel Good Morning, Midnight (1939) written by the Caribbean writer of the 20th century Jean Rhys. Jean Rhys’s novel Good Morning, Midnight depicts the life of woman who is poor, homele...

  2. Quantitative genetic variance and multivariate clines in the Ivyleaf morning glory, Ipomoea hederacea.

    Science.gov (United States)

    Stock, Amanda J; Campitelli, Brandon E; Stinchcombe, John R

    2014-08-19

    Clinal variation is commonly interpreted as evidence of adaptive differentiation, although clines can also be produced by stochastic forces. Understanding whether clines are adaptive therefore requires comparing clinal variation to background patterns of genetic differentiation at presumably neutral markers. Although this approach has frequently been applied to single traits at a time, we have comparatively fewer examples of how multiple correlated traits vary clinally. Here, we characterize multivariate clines in the Ivyleaf morning glory, examining how suites of traits vary with latitude, with the goal of testing for divergence in trait means that would indicate past evolutionary responses. We couple this with analysis of genetic variance in clinally varying traits in 20 populations to test whether past evolutionary responses have depleted genetic variance, or whether genetic variance declines approaching the range margin. We find evidence of clinal differentiation in five quantitative traits, with little evidence of isolation by distance at neutral loci that would suggest non-adaptive or stochastic mechanisms. Within and across populations, the traits that contribute most to population differentiation and clinal trends in the multivariate phenotype are genetically variable as well, suggesting that a lack of genetic variance will not cause absolute evolutionary constraints. Our data are broadly consistent theoretical predictions of polygenic clines in response to shallow environmental gradients. Ecologically, our results are consistent with past findings of natural selection on flowering phenology, presumably due to season-length variation across the range. © 2014 The Author(s) Published by the Royal Society. All rights reserved.

  3. Metastatic solid tumors to the jaw and oral soft tissue: A retrospective clinical analysis of 44 patients from a single institution.

    Science.gov (United States)

    Owosho, Adepitan A; Xu, Bin; Kadempour, Arvin; Yom, SaeHee K; Randazzo, Joseph; Ghossein, Ronald A; Huryn, Joseph M; Estilo, Cherry L

    2016-08-01

    Metastatic solid tumors to the oral cavity are rare, frequently indicative of an end-stage disease process, and associated with poor survival rates. We performed a 20-year retrospective clinical analysis of our institution's cases of solid metastases to the oral cavity, and investigated these patients' clinical outcomes. A retrospective study of patients with metastatic solid tumors to the oral cavity over a 20-year period (October 1996 to September 2015) was conducted at Memorial Sloan Kettering Cancer Center. Patients were selected if they had a histopathologically confirmed diagnosis. Demographic, pathologic, and clinical information were reviewed to identify patient outcomes. A total of 44 patients with metastatic non-melanocytic non-hematopoietic tumor to the oral cavity were identified: 24 males and 20 females (39 adults and 5 children) with a mean age of 54.3 years. In all, 24 cases involved the jaw and 20 cases involved the oral soft tissue. Eight patients (18.2%) had oral cavity metastases as the first indication of an occult malignancy. In adult patients, the common primary sites were the lungs (n = 9, 20%), kidney (n = 7, 16%), breast (n = 5, 11%), and colon (n = 4, 9%); and in pediatric patients the adrenal gland (3/5) was the most common site. Of the adult patients, 33 (84.6%) died of disease. From the time of metastasis diagnosis, patients with jaw metastases had a median and mean survival of 12 months and 27.7 months, respectively. In comparison, patients with oral soft tissue metastases had a median survival time of 5 months, and mean of 8 months. One pediatric patient (20%) died of disease 8 months after metastasis diagnosis. Metastatic solid tumors to the oral cavity can be the first sign of a malignancy. Pediatric patients with oral cavity metastases have a better prognosis compared to adult patients. In this series, adults with oral soft tissue involvement had shorter survival times compared to patients with jaw involvement. Copyright

  4. Immunogenicity and protective efficacy of a single-dose live non-pathogenic Escherichia coli oral vaccine against F4-positive enterotoxigenic Escherichia coli challenge in pigs.

    Science.gov (United States)

    Fairbrother, John Morris; Nadeau, Éric; Bélanger, Louise; Tremblay, Cindy-Love; Tremblay, Danielle; Brunelle, Mélanie; Wolf, Regina; Hellmann, Klaus; Hidalgo, Álvaro

    2017-01-05

    Enterotoxigenic Escherichia coli strains expressing F4 (K88) fimbriae (F4-ETEC) are one of the most important causes of post-weaning diarrhea (PWD) in pigs. F4, a major antigen, plays an important role in the early steps of the infection. Herein, the efficacy of a live oral vaccine consisting of a non-pathogenic E. coli strain expressing F4 for protection of pigs against PWD was evaluated. Three blinded, placebo-controlled, block design, parallel-group confirmatory experiments were conducted, using an F4-ETEC PWD challenge model, each with a different vaccination-challenge interval (3, 7, and 21days). The pigs were vaccinated via the drinking water with a single dose of the Coliprotec® F4 vaccine one day post-weaning. Efficacy was assessed by evaluating diarrhea, clinical observations, intestinal fluid accumulation, weight gain, intestinal colonization and fecal shedding of F4-ETEC. The immune response was evaluated by measuring serum and intestinal F4-specific antibodies. The administration of the vaccine resulted in a significant reduction of the incidence of moderate to severe diarrhea, ileal colonization by F4-ETEC, and fecal shedding of F4-ETEC after the heterologous challenge at 7 and 21days post-vaccination. The 7-day onset of protection was associated with an increase of serum anti-F4 IgM whereas the 21-day duration of protection was associated with an increase of both serum anti-F4 IgM and IgA. Significant correlations between levels of serum and intestinal secretory anti-F4 antibodies were detected. Maternally derived F4-specific serum antibodies did not interfere with the vaccine efficacy. The evaluation of protection following a challenge three days after vaccination showed a reduction of the severity and the duration of diarrhea and of fecal shedding of F4-ETEC. The 7-day onset and the 21-day duration of protection induced by Coliprotec® F4 vaccine administered once in drinking water to pigs of at least 18days of age were confirmed by protection

  5. Concentrations of garenoxacin in plasma, bronchial mucosa, alveolar macrophages and epithelial lining fluid following a single oral 600 mg dose in healthy adult subjects.

    Science.gov (United States)

    Andrews, J; Honeybourne, D; Jevons, G; Boyce, M; Wise, R; Bello, A; Gajjar, D

    2003-03-01

    A microbiological assay was used to measure concentrations of garenoxacin (BMS-284756) in plasma, bronchial mucosa (BM), alveolar macrophages (AM) and epithelial lining fluid (ELF), following a single 600 mg oral dose. Twenty-four healthy subjects were allocated into four nominal time intervals after the dose, 2.5-3.5, 4.5-5.5, 10.5-11.5 and 23.5-24.5 h. Mean concentrations in plasma, BM, AM and ELF, respectively, for the four nominal time windows were for 2.5-3.5 h 10.0 mg/L (S.D. 2.8), 7.0 mg/kg (S.D. 1.3), 106.1 mg/L (S.D. 60.3) and 9.2 mg/L (S.D. 3.6); 4.5-5.5 h 8.7 mg/L (S.D. 2.2), 6.0 mg/kg (S.D. 1.9), 158.6 mg/L (S.D. 137.4) and 14.3 mg/L (S.D. 8.2); 10.5-11.5 h 6.1 mg/L (S.D. 1.9), 4.0 mg/kg (S.D. 1.4), 76.0 mg/L (S.D. 47.7) and 7.9 mg/L (S.D. 4.6); and 23.5-24.5 h 2.1 mg/L (S.D. 0.5), 1.7 mg/kg (S.D. 0.7), 30.7 mg/L (S.D. 12.9) and 3.3 mg/L (S.D. 2.3). Concentrations at all sites exceeded MIC(90)s for the common respiratory pathogens Haemophilus influenzae (0.03 mg/L), Moraxella catarrhalis (0.015 mg/L) and Streptococcus pneumoniae (0.06 mg/L). These data suggest that garenoxacin should be effective in the treatment of community-acquired pneumonia and chronic obstructive pulmonary disease.

  6. Long term evolution of temperature in the venus upper atmosphere at the evening and morning terminators

    Science.gov (United States)

    Krause, P.; Sornig, M.; Wischnewski, C.; Kostiuk, T.; Livengood, T. A.; Herrmann, M.; Sonnabend, G.; Stangier, T.; Wiegand, M.; Pätzold, M.; Mahieux, A.; Vandaele, A. C.; Piccialli, A.; Montmessin, F.

    2018-01-01

    This paper contains a comprehensive dataset of long-term observations between 2009 and 2015 at the upper mesosphere/lower thermosphere providing temperature values at different locations of the morning and evening side of the terminator of Venus. Temperature information is obtained by line-resolved spectroscopy of Doppler broadened CO2 transitions features. Results are restricted to a pressure level of 1 μbar, ∼110 km altitude due the nature of the addressed non-LTE CO2 emission line at 10 μm. The required high spectral resolution of the instrumentation is provided by the ground-based spectrometers THIS (University of Cologne) and HIPWAC (NASA GSFC). For the first time upper mesosphere/lower thermosphere temperatures at the Venusian terminator derived from IR-het spectroscopy between 2009 and 2015 are investigated in order to clarify the local-time dependences, latitudinal dependences and the long-term trend. Measured temperatures were distributed in the range between 140 K and 240 K, with mean values equal to 199 K ± 17 K for the morning side of the terminator and 195 K ± 19 K for the evening side of the terminator. Within the uncertainty no difference between the averaged morning and evening terminator side temperature is found. In addition, no strong latitudinal dependency is observed at these near terminator local times. In contrast IR-het data from 2009 show a strong latitudinal dependency at noon, with a temperature difference of around 60 K between the equatorial and polar region (Sonnabend et al., 2012). Accord with the instruments of the Venus Express mission a northern-southern hemispherical symmetry is observed (Mahieux et al., 2012; Piccialli et al., 2015). The data shows no consistent long-term temperature trend throughout the six years of observation, but a variability in the order of tens of Kelvin for the different observing runs representing a time step of few month to two years. This is about the same order of magnitude as the variability

  7. Neuroticism and Morning Cortisol Secretion : Both Heritable, But No Shared Genetic Influences

    NARCIS (Netherlands)

    Riese, Harriette; Rijsdijk, Fruehling V.; Rosmalen, Judith G. M.; Snieder, Harold; Ormel, Johan

    2009-01-01

    Neuroticism is widely used as an explanatory concept in etiological research of psychopathology. To clarify what neuroticism actually represents, we investigated the phenotypic and genetic relationship between neuroticism and the morning cortisol secretion. In the current classic twin study, 125

  8. A single, low dose oral antigen exposure in newborn piglets primes mucosal immunity if administered with CpG oligodeoxynucleotides and polyphosphazene adjuvants.

    Science.gov (United States)

    Pasternak, J Alex; Ng, Siew Hon; Wilson, Heather L

    2014-10-15

    By definition, soluble antigens ingested orally trigger mucosal tolerance such that any subsequent re-exposure by a systemic route results in suppression of immunity. We propose that antigens introduced in extreme early life can readily traverse the gut wall and therefore circumvent induction of mucosal tolerance and instead induce immunity. Piglets were drenched with low-doses of ovalbumin (OVA; 5mg or 0.05 mg) alone, OVA plus adjuvants (CpG oligodeoxynucleotides and PCEP polyphosphazene) or saline within 6h of birth. At 28 days of age, they were administered 10mg OVA plus 1:1 Montanide adjuvant (or saline) via the intraperitoneal (i.p.) route or via the oral route. Serum was obtained on day 28 and day 49 to measure OVA-specific antibodies titres. All piglets boosted orally with OVA plus Montanide, regardless of prior OVA exposure, failed to induce immunity. As expected, piglets drenched with saline but boosted via the i.p. route with OVA plus Montanide showed significant induction of anti-OVA IgA, IgG, IgG1 and IgG2 relative to saline control piglets. Newborn animals drenched with 5mg or 0.05 mg OVA failed to induce oral immunity. A second intramuscular injection in adulthood triggered immunity in the piglets that were drenched with 0.05 mg OVA and boosted initially by the i.p. route suggesting that some systemic lymphocytes were primed despite initial lack of induction of humoral immunity. In contrast, piglets orally immunized with 5mg or 0.05 mg OVA plus adjuvants resulted in significant induction of anti-OVA IgA (5mg only), IgM, IgG, IgG1 and IgG2 in serum relative to saline control piglets as well as significant induction of anti-OVA IgA, IgM (5mg only) IgG, IgG1 (5mg only) or IgG2 relative to piglets drenched with OVA alone. These data clearly show that the response was sensitive to the oral vaccine components and was not simply a response to the i.p. immunization at day 28. This work demonstrates that newborn piglets respond to oral antigens with immunity

  9. Role and Structure of Morning Report in Children’s Teaching Hospitals in Iran

    Directory of Open Access Journals (Sweden)

    Maliheh Kadivar

    2011-07-01

    Full Text Available Background: Morning report is an integral component of medical training programs. It is conducted as "evidence based" or "problem based". It takes an efficient time of all members of the medical team in teaching hospitals, it seems necessary to evaluate its role in the education. Because of the importance of morning report in education, we evaluated the current and ideal conditions of morning report according to the opinions of medical teams in teaching children’s hospitals. Methods: A cross- sectional descriptive study conducted in three children’s teaching hospitals in Tehran in 2005. The opinion and perception of 358 participants, including faculties, residents, fellows, interns, and medical students, were collected by a questionnaire regarding the importance and structure of morning report. The data were presented as frequency and percentage. Results: 78% of respondents expected a high educational role for morning report. Although 317(88.54% had a regular attendance in morning report, only 34.1% were satisfied from current condition. The majority believed that faculty had better to lead the sessions, and voted for case presentation to be selected by senior resident on call, despite the prominent current leadership of the faculty. Most of the participants (88.6% preferred complicated and unusual cases for presentation. Current morning reports predominantly based on the presentation of the interesting or complicated cases were admitted on the previous day. A few number of cases were reintroduced after achieving the final diagnosis. In addition out-patients and those under observation in emergency room were usually ignored in the meetings. Conclusion: Regarding the educational role of morning report, there is a far distance between the present and ideal condition. Unattractiveness of presentations and poor participation in discussion might have negative impact on achieving the goals.

  10. Effect of azilsartan versus candesartan on morning blood pressure surges in Japanese patients with essential hypertension.

    Science.gov (United States)

    Rakugi, Hiromi; Kario, Kazuomi; Enya, Kazuaki; Sugiura, Kenkichi; Ikeda, Yoshinori

    2014-06-01

    Morning blood pressure (BP) surge is reported as a risk factor for cardiovascular events and end-organ damage independent of the 24-h BP level. Controlling morning BP surge is therefore important to help prevent onset of cardiovascular disease. We compared the efficacy of azilsartan and candesartan in controlling morning systolic BP (SBP) surges by analyzing relevant ambulatory BP monitoring data in patients with/without baseline BP surges. As part of a 16-week randomized, double-blind study of azilsartan (20-40 mg once daily) and candesartan (8-12 mg once daily) in Japanese patients with essential hypertension, an exploratory analysis was carried out using ambulatory BP monitoring at baseline and week 14. The effects of study drugs on morning BP surges, including sleep trough surge (early morning SBP minus the lowest night-time SBP) and prewaking surge (early morning SBP minus SBP before awakening), were evaluated. Patients with sleep trough surge of at least 35 mmHg were defined by the presence of a morning BP surge (the 'surge group'). Sleep trough surge and prewaking surge data were available at both baseline and week 14 in 548 patients, 147 of whom (azilsartan 76; candesartan 71) had a baseline morning BP surge. In surge group patients, azilsartan significantly reduced both the sleep trough surge and the prewaking surge at week 14 compared with candesartan (least squares means of the between-group differences -5.8 mmHg, P=0.0395; and -5.7 mmHg, P=0.0228, respectively). Once-daily azilsartan improved sleep trough surge and prewaking surge to a greater extent than candesartan in Japanese patients with grade I-II essential hypertension.

  11. Predictors and Trajectories of Morning Fatigue Are Distinct From Evening Fatigue.

    Science.gov (United States)

    Wright, Fay; D'Eramo Melkus, Gail; Hammer, Marilyn; Schmidt, Brian L; Knobf, M Tish; Paul, Steven M; Cartwright, Frances; Mastick, Judy; Cooper, Bruce A; Chen, Lee-May; Melisko, Michelle; Levine, Jon D; Kober, Kord; Aouizerat, Bradley E; Miaskowski, Christine

    2015-08-01

    Fatigue is the most common symptom in oncology patients during chemotherapy. Little is known about the predictors of interindividual variability in initial levels and trajectories of morning fatigue severity in these patients. An evaluation was done to determine which demographic, clinical, and symptom characteristics were associated with initial levels as well as the trajectories of morning fatigue and to compare findings with our companion paper on evening fatigue. A sample of outpatients with breast, gastrointestinal, gynecological, and lung cancer (n = 586) completed demographic and symptom questionnaires a total of six times over two cycles of chemotherapy. Fatigue severity was evaluated using the Lee Fatigue Scale. Hierarchical linear modeling was used to answer the study objectives. A large amount of interindividual variability was found in the morning fatigue trajectories. A piecewise model fit the data best. Patients with higher body mass index, who did not exercise regularly, with a lower functional status, and who had higher levels of state anxiety, sleep disturbance, and depressive symptoms reported higher levels of morning fatigue at enrollment. Variations in the trajectories of morning fatigue were predicted by the patients' ethnicity and younger age. The modifiable risk factors that were associated with only morning fatigue were body mass index, exercise, and state anxiety. Modifiable risk factors that were associated with both morning and evening fatigue included functional status, depressive symptoms, and sleep disturbance. Using this information, clinicians can identify patients at higher risk for more severe morning fatigue and evening fatigue, provide individualized patient education, and tailor interventions to address the modifiable risk factors. Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  12. Changes in morning salivary melatonin correlate with prefrontal responses during working memory performance.

    Science.gov (United States)

    Killgore, William D S; Kent, Haley C; Knight, Sara A; Alkozei, Anna

    2018-04-11

    Humans demonstrate a circadian rhythm of melatonin production that closely tracks the daily light/dark cycle, with profound increases in circulating levels during the night-time and nearly nonexistent levels during daylight hours. Although melatonin is known to play a role in preparing the brain and body for sleep, its effects on cognition and brain function are not well understood. We hypothesized that declines in morning melatonin would be associated with increased functional activation within cortical regions involved in alertness, attention, and executive function. We measured the change in salivary melatonin from mid-morning to late-morning in 26 healthy young adults who were also exposed to a 30-min period of blue or amber light followed by functional MRI during a working memory task (N-back). Brain activation was regressed on the change in melatonin scores from the mid-morning to late-morning saliva samples and the role of light exposure was also assessed. Although overall melatonin levels did not change significantly over the morning at the group level, individual declines in salivary melatonin were associated with significant increases in activation within the left dorsomedial and right inferior lateral prefrontal cortex during the 2-back condition (Pmorning are associated with increased prefrontal cortex functioning and may play a role in the increased frontal activation that occurs following awakening.

  13. Morning blood pressure surge and arterial stiffness in newly diagnosed hypertensive patients.

    Science.gov (United States)

    Kıvrak, Ali; Özbiçer, Süleyman; Kalkan, Gülhan Yüksel; Gür, Mustafa

    2017-06-01

    We aimed to investigate the relationship between the morning blood pressure (BP) surge and arterial stiffness in patients with newly diagnosed hypertension. Three hundred and twenty four (mean age 51.7 ± 11.4 years) patients who had newly diagnosed hypertension with 24 h ambulatory BP monitoring were enrolled. Parameters of arterial stiffness, pulse wave velocity and augmentation index (Aix) were measured by applanation tonometry and aortic distensibility was calculated by echocardiography. Compared with the other groups, pulse wave velocity, day-night systolic BP (SBP) difference (p morning BP surge high group. Aortic distensibility values were significantly lower in morning BP surge high group compared to the other groups (p Morning BP surge was found to be independently associated with pulse wave velocity (β = 0.286, p morning BP surge and arterial stiffness which is a surrogate endpoint for cardiovascular diseases. The inverse relationship between morning BP surge and aortic distensibility and direct relation found in our study is new to the literature.

  14. Morning glory disc anomaly with an ipsilateral enlargement of the optic nerve pathway.

    Science.gov (United States)

    Thoma, D; Nijs, I; Demaerel, P; Casteels, I

    2017-09-01

    To report three patients with an unilateral morning glory disc anomaly in association with an ipsilateral mild thickening of the optic nerve. Three children with a morning glory disc anomaly underwent a magnetic resonance imaging (MRI) of the brain. Ophthalmological, genetic and MRI findings at follow-up are reported. A literature search on the association of morning glory anomaly in association with optic nerve glioma is reported. 1 RESULTS: Three children with an unilateral morning glory anomaly and ipsilateral poor visual acuity were found to have an ipsilateral mild optic nerve enlargement on brain MRI. At serial MRI scanning, there was no progression of this finding. The morning glory disc anomaly is a rare congenital malformation of the optic disc. It can be associated with central nervous system abnormalities. The association with an optic nerve glioma has been described once before. 1 Our three cases confirm the possible association between a morning glory disc anomaly and an ipsilateral optic nerve enlargement. Serial MRI showed no growth at follow-up. The awareness of this association by the ophthalmologists is important. Copyright © 2017 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

  15. Basal encephalocele associated with morning glory syndrome: case report Encefalocele basal associada a síndrome "morning glory": relato de caso

    Directory of Open Access Journals (Sweden)

    Ivanete Minotto

    2007-12-01

    Full Text Available The basal encephaloceles refer to rare entities and they correspond to herniation of brain tissue through defects of skull along the cribiform plate or the sphenoid bone. A rare morning glory syndrome, with characteristic retinal defect has been reported in association with basal encephaloceles. Hypophysis hormonal deficiencies may occur. We accounted for a pituitary dwarfism with delayed diagnosed transsphenoidal encephalocele associated with morning glory syndrome, showing the alterations found in retinography, computed tomography and magnetic resonance imaging.As encefaloceles basais são entidades raras e correspondem a herniações do tecido cerebral através de um defeito do crânio, ao longo da lâmina crivosa etmoidal ou do osso esfenoidal. A rara síndrome morning glory, com alterações de fundo de olho características pode apresentar-se associada à encefalocele basal. Deficiências hormonais hipofisárias podem ocorrer. Relatamos caso de nanismo hipofisário com encefalocele transesfenoidal de diagnóstico tardio associada à síndrome de morning glory, mostrando as alterações na retinografia, tomografia computadorizada e ressonância magnética.

  16. Oral cancer trends in a single head-and-neck cancer center in the Netherlands; decline in T-stage at the time of admission

    NARCIS (Netherlands)

    Weijers, M.; Leemans, C.R.; Aartman, I.H.; Karagozoglu, K.H.; van der Waal, I.

    2011-01-01

    OBJECTIVES: In this study we evaluated the possible epidemiologic changes of oral cancer patients in the Netherlands between the years 1980-1984 and 2000-2004. We specifically studied the differences in male-female ratio, age, TNM-stage, site distribution, and alcohol and tobacco use. MATERIALS AND

  17. Oral myiasis

    Directory of Open Access Journals (Sweden)

    Thalaimalai Saravanan

    2015-01-01

    Full Text Available Myiasis is a pathologic condition in humans occurring because of parasitic infestation. Parasites causing myiasis belong to the order Diptera. Oral myiasis is seen secondary to oral wounds, suppurative lesions, and extraction wounds, especially in individuals with neurological deficit. In such cases, neglected oral hygiene and halitosis attracts the flies to lay eggs in oral wounds resulting in oral myiasis. We present a case of oral myiasis in 40-year-old male patient with mental disability and history of epilepsy.

  18. Efficacy and short-term outcomes of preoperative chemoradiotherapy with intermittent oral tegafur-uracil plus leucovorin in Japanese rectal cancer patients: a single center experience retrospective analysis.

    Science.gov (United States)

    Nakagawa, Ryosuke; Inoue, Yuji; Ohki, Takeshi; Kaneko, Yuka; Maeda, Fumi; Yamamoto, Masakazu

    2017-05-31

    Various types of preoperative chemoradiotherapy (CRT) have been established for rectal cancer; thus, Physicians will need to refine the selection of appropriate preoperative CRT for different patients since there are various treatment regimens. Oral tegafur-uracil (UFT) plus leucovorin (LV) is commonly used to treat rectal cancer in Japan. Oral chemotherapy offers patients many potential advantages. Since 2008, we have been performing preoperative CRT with intermittent oral UFT plus LV in locally advanced rectal cancer patients to prevent postoperative local recurrence. Here, in a retrospective analysis, we evaluated the efficacy and short-term outcomes of preoperative CRT with intermittent oral UFT plus LV. We analyzed data from 62 patients with locally advanced rectal cancer, including 31 patients who underwent preoperative CRT between 2009 and 2013 (the CRT group) and 31 patients who were treated with surgery alone between 2001 and 2008 (the non-CRT group). Clinicopathologically, both groups included patients with rectal cancer at clinical tumor stages III-IV or clinical node stages 0-III. In the CRT group, curative operations were performed ≥8 weeks after CRT. Patients were concomitantly treated with 2 cycles of oral UFT (300 mg/m 2 /day, days 1-14 and 29-42) plus LV (75 mg/day, days 1-14 and 29-42) and 45 Gy of radiotherapy. Chemotherapy was repeated every 28 days, followed by a 2-week break. The completion rate of CRT was high at 94% (n = 29/31). The downstaging rate of CRT was 61% (n = 19/31). The pathological complete response rate was 6.5% (n = 2/31). Significant differences were observed in the 3-year local recurrence rate between the two groups (P rectal cancer. A further investigation of a diversification of preoperative CRT for Japanese rectal cancer patients is required.

  19. Shoot and root interference of morning glory on the initial growth of sugarcane.

    Science.gov (United States)

    Alves, Felipe C; Bianco, Silvano; Nepomuceno, Mariluce P; Martins, José Valcir F; Alves, Pedro Luís C A

    2018-02-19

    Among weeds, morning glories comprise a very important group of climbing plants that infest sugarcane crops. The objective of this study was to evaluate the shoot and root interference of Merremia cissoides on the initial growth of sugarcane cultivar RB 966928. The experiment consisted of five treatment groups: (i) sugarcane monocropping, (ii) morning glory monocropping, (iii) sugarcane intertwined with morning glory but inseparate boxes, (iv) sugarcane intertwined with morning glory in attached boxes and (v) sugarcane with morning glory in attached boxes with morning glory prevented from intertwining with the sugarcane. The experimental design consisted of randomized blocks with four replicates. Merremia cissoides adversely affected the initial growth of the RB 966928 sugarcane starting at 90 days after transplanting (DAT). This effect increased with the time of intercropping, reaching at 180 DAT with a reduction of 57.3% in height,15.5% in stalk diameter, 90.4% in leaf areas, 86.6 and 75.2% in stalk and leaf dry mass, respectively. These reductions primarily due to the weed intertwining with the sugarcane plants because the weed had a physical choking and shading effect. This negative effect of morning glory on the sugarcane plants increased when they shared the substrate (i.e., when they competed for space and water), which also adversely affected weed growth, reducing 50.2% leaf areas and 42.1% shoot dry mass. The leaf area and the stalk and leaf dry mass of sugarcane are the characteristics more sensitive to the weed interference. Thus, both the shoot and root of M. cissoides interferes negatively in the growth of sugarcane, with the effect proportional to the period of coexistence, highlighting the detrimental effect on the stem (greater economic interest), and may also compromise the mechanical harvesting of the crop.

  20. Morning and evening physical exercise differentially regulate the autonomic nervous system during nocturnal sleep in humans.

    Science.gov (United States)

    Yamanaka, Yujiro; Hashimoto, Satoko; Takasu, Nana N; Tanahashi, Yusuke; Nishide, Shin-Ya; Honma, Sato; Honma, Ken-Ichi

    2015-11-01

    Effects of daily physical exercise in the morning or in the evening were examined on circadian rhythms in plasma melatonin and core body temperature of healthy young males who stayed in an experimental facility for 7 days under dim light conditions (Sleep polysomnogram (PSG) and heart rate variability (HRV) were also measured. Subjects performed 2-h intermittent physical exercise with a bicycle ergometer at ZT3 or at ZT10 for four consecutive days, where zeitgeber time 0 (ZT0) was the time of wake-up. The rising phase of plasma melatonin rhythm was delayed by 1.1 h without exercise. Phase-delay shifts of a similar extent were detected by morning and evening exercise. But the falling phase shifted only after evening exercise by 1.0 h. The sleep PSG did not change after morning exercise, while Stage 1+2 sleep significantly decreased by 13.0% without exercise, and RE sleep decreased by 10.5% after evening exercise. The nocturnal decline of rectal temperature was attenuated by evening exercise, but not by morning exercise. HRV during sleep changed differentially. Very low frequency (VLF) waves increased without exercise. VLF, low frequency (LF), and high frequency (HF) waves increased after morning exercise, whereas HR increased after evening exercise. Morning exercise eventually enhanced the parasympathetic activity, as indicated by HRV, while evening exercise activated the sympathetic activity, as indicated by increase in heart rate in the following nocturnal sleep. These findings indicated differential effects of morning and evening exercise on the circadian melatonin rhythm, PSG, and HRV. Copyright © 2015 the American Physiological Society.

  1. Single abnormal value on 3-hour oral glucose tolerance test during pregnancy is associated with adverse maternal and neonatal outcomes: a systematic review and metaanalysis.

    Science.gov (United States)

    Roeckner, Jared T; Sanchez-Ramos, Luis; Jijon-Knupp, Rubymel; Kaunitz, Andrew M

    2016-09-01

    The purpose of this study was to determine whether women with 1 abnormal value on 3-hour 100-g oral glucose tolerance test are at an increased risk for adverse pregnancy outcomes. Gestational diabetes mellitus is diagnosed by a 2-step method, with a 3-hour, 100-g oral glucose tolerance test that is reserved for women with an abnormal 1-hour, 50-g glucose challenge test. Although the increased maternal-fetal morbidity with gestational diabetes mellitus is well established, controversy remains about the risk that is associated with an isolated abnormal value during a 3-hour, 100-g oral glucose tolerance test. Prospective and retrospective studies that evaluated the maternal and perinatal impact of 1 abnormal glucose value during a 3-hour, 100-g oral glucose tolerance test were identified with the use of computerized databases. Data were extracted and quantitative analyses were performed. Twenty-five studies (7 prospective and 18 retrospective) that met criteria for metaanalysis included 4466 women with 1 abnormal glucose value on oral glucose tolerance test. Patients with 1 abnormal glucose value had significantly worse pregnancy outcomes compared with women with zero abnormal values with the following pooled odds ratios: macrosomia, 1.59 (95% confidence interval, 1.16-2.19); large for gestational age, 1.38 (95% confidence interval, 1.09-1.76); increased mean birthweight, 44.5 g (95% confidence interval, 8.10-80.80 g); neonatal hypoglycemia, 1.88 (95% confidence interval, 1.05-3.38); total cesarean delivery, 1.69 (95% confidence interval, 1.40-2.05); pregnancy-induced hypertension, 1.55 (95% confidence interval, 1.31-1.83), and Apgar score of test (normal glucose screen). With the exception of birthweight, outcomes of patients with 1 abnormal glucose value were similar to outcomes of patients with gestational diabetes mellitus. Women with 1 abnormal value on 3-hour, 100-g oral glucose tolerance test have a significantly increased risk for poor outcomes comparable

  2. Inflammatory pathway genes associated with inter-individual variability in the trajectories of morning and evening fatigue in patients receiving chemotherapy.

    Science.gov (United States)

    Wright, Fay; Hammer, Marilyn; Paul, Steven M; Aouizerat, Bradley E; Kober, Kord M; Conley, Yvette P; Cooper, Bruce A; Dunn, Laura B; Levine, Jon D; DEramo Melkus, Gail; Miaskowski, Christine

    2017-03-01

    Fatigue, a highly prevalent and distressing symptom during chemotherapy (CTX), demonstrates diurnal and interindividual variability in severity. Little is known about the associations between variations in genes involved in inflammatory processes and morning and evening fatigue severity during CTX. The purposes of this study, in a sample of oncology patients (N=543) with breast, gastrointestinal (GI), gynecological (GYN), or lung cancer who received two cycles of CTX, were to determine whether variations in genes involved in inflammatory processes were associated with inter-individual variability in initial levels as well as in the trajectories of morning and evening fatigue. Patients completed the Lee Fatigue Scale to determine morning and evening fatigue severity a total of six times over two cycles of CTX. Using a whole exome array, 309 single nucleotide polymorphisms SNPs among the 64 candidate genes that passed all quality control filters were evaluated using hierarchical linear modeling (HLM). Based on the results of the HLM analyses, the final SNPs were evaluated for their potential impact on protein function using two bioinformational tools. The following inflammatory pathways were represented: chemokines (3 genes); cytokines (12 genes); inflammasome (11 genes); Janus kinase/signal transducers and activators of transcription (JAK/STAT, 10 genes); mitogen-activated protein kinase/jun amino-terminal kinases (MAPK/JNK, 3 genes); nuclear factor-kappa beta (NFkB, 18 genes); and NFkB and MAP/JNK (7 genes). After controlling for self-reported and genomic estimates of race and ethnicity, polymorphisms in six genes from the cytokine (2 genes); inflammasome (2 genes); and NFkB (2 genes) pathways were associated with both morning and evening fatigue. Polymorphisms in six genes from the inflammasome (1 gene); JAK/STAT (1 gene); and NFkB (4 genes) pathways were associated with only morning fatigue. Polymorphisms in three genes from the inflammasome (2 genes) and the NFk

  3. Consecutive first-morning urine samples to measure change in the albumin-to-creatinine ratio: a pilot study of a home urine collection protocol.

    Science.gov (United States)

    Sontrop, Jessica M; Garg, Amit X; Li, Lihua; Gallo, Kerri; Schumann, Virginia; Winick-Ng, Jennifer; Clark, William F; Weir, Matthew A

    2016-01-01

    Multiple first-morning urine samples are recommended for measuring the urine albumin-to-creatinine ratio (ACR); however, this can be challenging in community-based research. The objectives of the study are to pilot-test a home urine collection protocol and examine how the average and variance of ACR varied with the number of urine collections and time to laboratory analysis. This is a prospective observational pilot study. This study was conducted in London, Ontario, Canada at the London Health Sciences Centre (2012-2013). The patients were adults with chronic kidney disease (mean estimated glomerular filtration rate, 36 mL/min/1.73 m(2)). Participants collected a first-morning 20-mL urine sample on three consecutive days. This process was repeated after 3 months. Samples were picked up by hospital courier and analyzed for ACR on the same day; additional aliquots were analyzed after a delay of 24-48 h (stored at 4 °C) and 3-9 months (stored at -80 °C). The geometric mean of the percentage change in ACR between baseline and 3 months was calculated and compared between single samples and the average of two vs. three consecutive samples. Of 31 patients enrolled, 26 (83.9 %) submitted all six urine samples. The geometric mean of ACR for three consecutive samples at baseline was 87, 83, and 80 mg/mmol, and the corresponding percentage increase from baseline to 3 months was 15 % (95 % confidence interval (CI), -9 to 46 %), 33 % (95 % CI, 10 to 59 %), and 22 % (95 % CI, -6 to 57 %). Compared with single urine collections at baseline and follow-up, averaging ACR values from two consecutive first-morning urine samples improved the sample variance and reduced the required sample size to detect a given treatment effect by approximately 30 %. No further gain in statistical efficiency was achieved with three urine samples. Results were similar when the laboratory analysis was delayed by 24-48 h, but a delay of 3-9 months resulted in systematic

  4. No effect of acute, single dose oral administration of Momordica charantia Linn., on glycemia, energy expenditure and appetite: a pilot study in non-diabetic overweight men.

    Science.gov (United States)

    Kasbia, Gursevak S; Arnason, Jon Thor; Imbeault, Pascal

    2009-10-29

    Momordica charantia Linn. Cucurbitaceae (MC), has been used to treat glycemic impairment in humans for centuries. The objective of this study was to determine the acute effect of MC on postprandial glucose levels, energy expenditure/fuel mixture and appetite in overweight men. Five healthy overweight men were supplemented on three randomized conditions where (1) no MC (placebo), (2) 50 mg/kg body weight (MC50) or (3) 100 mg/kg body weight of freeze dried MC were administered orally prior to a 75 g oral glucose tolerance test (OGTT). Plasma glucose and insulin levels were measured before and during the OGTT. Energy expenditure as well as carbohydrate and lipid oxidation rates were measured by indirect calorimetry. Visual analogue scales were used to rate appetite profile. Plasma glucose and insulin levels significantly increased during the OGTT (p diabetic overweight men.

  5. Morning pentraxin3 levels reflect obstructive sleep apnea-related acute inflammation.

    Science.gov (United States)

    Kobukai, Yusuke; Koyama, Takashi; Watanabe, Hiroyuki; Ito, Hiroshi

    2014-11-15

    This study investigated morning levels of pentraxin3 (PTX3) as a sensitive biomarker for acute inflammation in patients with obstructive sleep apnea (OSA). A total of 61 consecutive patients with OSA were divided into two groups: non-to-mild (n = 20) and moderate-to-severe (n = 41) OSA based on their apnea-hypopnea index (AHI) score. Those patients with moderate-to-severe OSA were further divided into continuous positive airway pressure (CPAP) treated (n = 21) and non-CPAP-treated (n = 20) groups. Morning and evening serum PTX3 and high-sensitivity (hs) C-reactive protein (CRP) levels were measured before and after 3 mo of CPAP therapy. The baseline hs-CRP and PTX3 levels were higher in patients with moderate-to-severe OSA than in those with non-to-mild OSA. Moreover, the serum PTX3 levels, but not the hs-CRP levels, were significantly higher after than before sleep in the moderate-to-severe OSA group (morning PTX3, 1.96 ± 0.52; evening PTX3, 1.71 ± 0.44 ng/ml). OSA severity as judged using the AHI was significantly correlated with serum PTX3 levels but not hs-CRP levels. The highest level of correlation was found between the AHI and morning PTX3 levels (r = 0.563, P morning serum hs-CRP and PTX3 levels in patients with moderate-to-severe OSA; however, the reduction in PTX3 levels in the morning was greater than that in the evening (morning -29.8 ± 16.7% vs. evening -12.6 ± 26.8%, P = 0.029). Improvement in the AHI score following CPAP therapy was strongly correlated with reduced morning PTX3 levels(r = 0.727, P morning PTX3 levels reflect OSA-related acute inflammation and are a useful marker for improvement in OSA following CPAP therapy. Copyright © 2014 the American Physiological Society.

  6. A survey of oral and maxillofacial biopsies in children: a single-center retrospective study of 20 years in Pelotas-Brazil

    Directory of Open Access Journals (Sweden)

    Giana da Silveira Lima

    2008-12-01

    Full Text Available Despite the large number of published cases about oral and maxillofacial pediatric lesions, the literature is scarce on epidemiological studies regarding the prevalence of these entities. This study retrieved oral and maxillofacial pediatric lesions from the Center of Diagnosis of Oral Diseases (CDDB at the Dental School of the Federal University of Pelotas (UFPEL, comprising a 20-year period (1983-2002. From the total of 9,465 biopsies received in this period, 625 (6.6% were from children aged 0 to 14 years. Regardless of the histopathological diagnosis, patient data referring to lesion location, sex and age were collected. Diagnoses were grouped in 13 categories. As much as 89% of the cases occurred in patients aged 7 to 14 years (53% in females and 47% in males. Mucocele (17.2% was the most common type of lesion, followed by dentigerous cyst (8.6%. In the category of odontogenic tumors, odontoma was the most frequent lesion (64.2%. Malignant lesions were observed in a small section of the sample (1.2%. Generally, the results of the present study are in line with those reported in the literature concerning the most prevalent lesions in the pediatric population. Most lesions were benign, and malignant lesions were diagnosed in a very small part of the sample.

  7. Morning report blog: a web-based tool to enhance case-based learning.

    Science.gov (United States)

    Bogoch, Isaac I; Frost, David W; Bridge, Suzanne; Lee, Todd C; Gold, Wayne L; Panisko, Daniel M; Cavalcanti, Rodrigo B

    2012-01-01

    Morning report is an interactive case-based teaching session common to internal medicine training programs across North America. We report here on a morning report web log ("blog"), created and updated after morning report sessions by the Chief Medical Resident with pertinent clinical topics, links to journal articles, and medical images. Trainees on their internal medicine rotation were e-mailed a web link with each posting. The aim was to enhance learning on clinical topics discussed at morning report by reinforcing topics and promoting further reading. The educational impact of the blog was evaluated using detailed web metrics and surveys of attendees. The intended audience spent on average more than 5 min reading the blog and viewed more than 3 pages per visit. Almost half of attendees accessed the blog after completing their internal medicine rotation. The blog was also accessed by a global audience. Trainees rated the blogs a useful learning tool and cited it to be among the top 3 educational resources accessed during their rotation. In summary, a morning report blog was perceived by learners to be an effective complement to case-based teaching sessions. The combination of novel web metrics and survey data allowed for a multifaceted evaluation of the educational impact of the blog.

  8. Apomorphine Subcutaneous Injection for the Management of Morning Akinesia in Parkinson's Disease.

    Science.gov (United States)

    Isaacson, Stuart; Lew, Mark; Ondo, William; Hubble, Jean; Clinch, Thomas; Pagan, Fernando

    2017-01-01

    In patients with motor fluctuations complicating Parkinson's disease (PD), delays in time-to-ON with levodopa are common. This open-label study aimed to assess the effect of apomorphine on time-to-ON in PD patients with morning akinesia. The safety population included 127 enrolled patients, and the full analysis set (FAS) included 88 patients. Patients completed a 7-day levodopa baseline period recording their time-to-ON following each morning dose of levodopa. Patients were titrated to an optimal dose of apomorphine (2-6 mg) while taking trimethobenzamide antiemetic therapy. Apomorphine was injected each morning for a 7-day treatment period and time-to-ON was self-recorded in 5-minute blocks. The primary efficacy variable was time-to-ON in the apomorphine treatment period versus the baseline levodopa period. Secondary assessments included and global impression scales. Safety and tolerability were assessed through adverse events (AEs). Patients receiving apomorphine achieved mean ± standard deviation (SD) time-to-ON 23.72 ± 14.55 minutes, reduced from 60.86 ± 18.11 minutes with levodopa ( P 60 minutes) were more commonly reported with levodopa versus apomorphine (46% vs. 7% of diary entries, respectively). Secondary endpoints supported the primary efficacy findings, with significant improvements from levodopa baseline to apomorphine treatment period (all P morning levodopa dose, and was well tolerated in most patients. After apomorphine treatment, fluctuating patients with morning akinesia experienced rapid and reliable improvement of time-to-ON.

  9. Utilization of Morning Report by Acute Care Surgery Teams: Results from a Qualitative Study

    Science.gov (United States)

    Pringle, Patricia L.; Collins, Courtney; Santry, Heena P.

    2013-01-01

    Background The rigor of hand-offs is increasingly scrutinized in the era of shift-based patient care. Acute Care Surgery (ACS) embraced such a model of care; however, little is known about hand-offs in ACS programs. Methods We conducted 18 open-ended interviews with ACS leaders representing diverse geographic and practice settings. Two independent reviewers analyzed interviews using an inductive approach to elucidate themes regarding use of morning report (NVivo qualitative analysis software). Results 12/18 respondents reported a morning report but only 6/12 included attending-to-attending hand-offs. 1/12 incentivized attendings to participate, 2/12 included nursing staff, and 2/12 included physician extenders. Cited benefits of morning report were safe and effective information exchange (2/12), quality improvement (2/12), multidisciplinary discussion (1/12), and resident education (2/12). 3/12 respondents cited time commitment as the main limitation of morning report. Conclusions Morning report is under-utilized among ACS programs; however, if implemented strategically, it may improve patient care and resident education. PMID:24157348

  10. Standing body sway in women with and without morning sickness in pregnancy.

    Science.gov (United States)

    Yu, Yawen; Chung, Hyun Chae; Hemingway, Lauren; Stoffregen, Thomas A

    2013-01-01

    Morning sickness typically is attributed to hormonal changes in pregnancy. We asked whether morning sickness is associated with changes in standing postural equilibrium, as occurs in research on visually induced motion sickness. Twenty-one pregnant women (mean age=30 years, mean height=163cm; mean weight=63kg) were tested during the first trimester. Laboratory-based balance measures were collected, along with perceived postural stability, the presence of morning sickness, and the severity of subjective symptoms. We varied the distance between the feet and the visual task performed during stance. Participants were classified as either experiencing (Sick, n=12) or not experiencing (Well, n=9) morning sickness. Perceived balance stability was lower for Sick than for Well women. The positional variability of sway was reduced for the Sick group, relative to the Well group. Positional variability decreased with wider stance width, and was reduced during performance of a more demanding visual task. Stance width and visual task also influenced the temporal dynamics of sway. Effects of stance width and visual task on postural sway were similar to effects in non-pregnant adults, suggesting that sensitive tuning of posture is maintained during the first trimester. The findings suggest that women with morning sickness may attempt to stabilize their bodies by reducing overall body sway. It may be useful to recommend that women adopt wider stance early in pregnancy. Copyright © 2012 Elsevier B.V. All rights reserved.

  11. [The alternative method for albuminuria determination: second morning urine sample instead of 24-hour urine collection].

    Science.gov (United States)

    Barska, Iga; Mikołajczyk, Melania; Paradowski, Marek

    2013-05-01

    Urinary albumin excretion is an established risk factor for renal and cardiovascular events. Measurement of albumin in the urine daily collection is the gold standard in assessing albuminuria. The 24-hour urine collection is cumbersome procedure that generates a lot of mistakes, therefore other methods have been proposed. The aim of the study was to compare the assessment of albuminuria in the 24-hour urine collection and in the second morning urine sample as well as to determine UACR. The study included 32 patients, from whom the daily and the second morning urine samples were collected. In both samples, the albumin and creatinine concentrations were determined and the urinary albumin: creatinine ratio (UACR) was calculated. An excellent correlation between the UACR determined from the 24-hour urine collection and the other portion of the second morning sample was obtained within a wide range of albuminuria values (r = 0.9825). Furthermore, a better correlation between the same characteristics was obtained in urine of patients with normoalbuminuria when UACR did not exceed 30 mg/g creatinine (r = 0.9771). Above this value, the correlation was slightly lower for micro- and macroalbuminuria and equalled 0.9249 and 0.9332, respectively. On the basis of the obtained results it can be concluded that the second morning urine sample with the determination of UACR is a good alternative to the 24-hour urine collection and the first morning urine sample which are burdened with a preanalytical error.

  12. Coming back to work in the morning: Psychological detachment and reattachment as predictors of work engagement.

    Science.gov (United States)

    Sonnentag, Sabine; Kühnel, Jana

    2016-10-01

    Research has shown that recovery processes in general and psychological detachment in particular are important for work engagement. We argue that work engagement additionally benefits from reattachment to work in the morning (i.e., mentally reconnecting to work before actually starting to work) and that the gains derived from psychological detachment and reattachment are stronger in the morning than in the afternoon. We tested our hypotheses in a daily diary study with a sample of 167 employees who completed 2 surveys per day over the period of 2 workweeks. Hierarchical linear modeling showed that work engagement was higher in the morning than in the afternoon. Evening psychological detachment and morning reattachment positively predicted work engagement throughout the day. The association between reattachment and work engagement was stronger in the morning than in the afternoon. This study demonstrates that not only psychological detachment from work during leisure time, but also reattachment to work when coming back to work are crucial for daily engagement at work. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  13. What Is the Relationship Between Morning Symptoms and Measures of Disease Activity in Patients With Rheumatoid Arthritis?

    Science.gov (United States)

    Boers, M; Buttgereit, F; Saag, K; Alten, R; Grahn, A; Storey, D; Rice, P; Kirwan, J

    2015-09-01

    Little is known about the relationship between morning symptoms of rheumatoid arthritis (RA) and measures of disease activity currently used to assess RA. Information available from the Circadian Administration of Prednisone in Rheumatoid Arthritis (CAPRA-2) study was used to investigate these relationships. CAPRA-2 included 350 patients with RA who were symptomatic despite treatment with disease-modifying antirheumatic drugs, randomized 2:1 to additional treatment with a 5-mg daily dose of delayed-release prednisone or placebo. Pearson's correlations were used to evaluate the relationships between change from baseline in symptoms (duration of morning stiffness, severity of morning stiffness, and intensity of pain on waking) and measures of disease activity (the American College of Rheumatology 20% improvement criteria [ACR20], the Disease Activity Score in 28 joints [DAS28], and the Health Assessment Questionnaire disability index). Correlations were defined as weak (0.7). There was a strong correlation between the severity of morning stiffness and the intensity of morning pain (Pearson's correlation 0.91, P morning stiffness and measures of disease activity (0.24-0.28), with moderate correlations between the severity of morning stiffness or intensity of pain on waking and DAS28 or ACR20 scores (0.44-0.48). Severity of morning stiffness showed less variability and a greater effect size than did duration of morning stiffness. Morning symptoms and measures of disease activity show weak to moderate correlations. Severity of morning stiffness showed less variability and greater effect size than did duration of morning stiffness. These findings suggest that severity is the preferred construct to measure the impact of morning stiffness in patients with RA, information that is not fully captured in the RA core set. © 2015, American College of Rheumatology.

  14. The efficacy of once-daily fluticasone furoate/vilanterol in asthma is comparable with morning or evening dosing.

    Science.gov (United States)

    Kempsford, Rodger D; Oliver, Amanda; Bal, Joanne; Tombs, Lee; Quinn, Dean

    2013-12-01

    To investigate the effect of time of day of dosing (morning or evening) on lung function following administration of fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg. Double-blind, placebo-controlled, randomised, three-way crossover study. Subjects with persistent asthma (N = 26) received FF/VI (morning or evening) or matching placebo once-daily for 14 (± 2 days) via dry powder inhaler (DPI). Weighted mean (0-24h) and pre-treatment FEV1 (morning and evening) were determined after the Day 14 evening dose, together with mean pre-treatment (morning and evening) peak expiratory flow (PEF) on Days 2-12. FF/VI 100/25 administered morning or evening produced clinically significant increases in weighted mean FEV1: the differences [95% confidence interval (CI)] from placebo were 377 mL [293, 462] and 422 mL [337, 507], respectively; the difference between morning and evening dosing was -44 mL [-125, 36]. Day 14 pre-treatment morning FEV1 differences [95% CI] from placebo were 403 mL [272, 533] and 496 mL [369, 624] after morning and evening dosing, respectively; the morning:evening treatment difference was -94 mL [-221, 34]. Pre-treatment evening FEV1 differences [95% CI] from placebo were 275 mL [169, 380] and 309 mL [205, 413] after morning and evening dosing, respectively; the morning:evening treatment difference was -34 mL [-138, 70]. FF/VI (morning or evening) produced rapid increases in PEF with the full effect apparent after the first dose and maintained throughout the 14-day treatment period. FF/VI 100/25 produces comparable improvements in lung function whether dosed in the morning or evening in subjects with persistent asthma. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

  15. INTRAVITREAL AFLIBERCEPT IN THE TREATMENT OF POLYPOIDAL CHOROIDAL VASCULOPATHY ASSOCIATED WITH MORNING GLORY SYNDROME.

    Science.gov (United States)

    Iovino, Claudio; Fossarello, Maurizio; Peiretti, Enrico

    2018-01-10

    To describe an unusual case of polypoidal choroidal vasculopathy secondary to morning glory syndrome successfully treated with three aflibercept intravitreal injections. Case report. A 68-year-old white man presented with a 2-month history of diminished vision of his left eye. Fundus examination showed a morning glory syndrome disk anomaly with some perimacular subretinal hemorrhages and lipid depositions. Fundus autofluorescence, fluorescein and green indocyanine angiography, spectral domain optical coherence tomography, and optical coherence tomography angiography were performed and confirmed the presence of a juxtapapillary polypoidal choroidal vasculopathy with intraretinal and subretinal fluid. Patient underwent 3 monthly intravitreal injections of aflibercept and at 4-month follow-up visit, multimodal imaging findings did not show any kind of neovascular lesion activity. Polypoidal choroidal vasculopathy can occur in morning glory syndrome and it can be successfully treated with anti-vascular endothelial growth factor intravitreal injections of aflibercept.

  16. Differential islet and incretin hormone responses in morning versus afternoon after standardized meal in healthy men

    DEFF Research Database (Denmark)

    Lindgren, Ola; Mari, Andrea; Deacon, Carolyn F

    2009-01-01

    CONTEXT: The insulin response to meal ingestion is more rapid in the morning than in the afternoon. Whether this is explained by a corresponding variation in the incretin hormones is not known. OBJECTIVE: Our objective was to assess islet and incretin hormones after meal ingestion in the morning vs....... afternoon. DESIGN, SETTINGS, AND PARTICIPANTS: Ingestion at 0800 and 1700 h of a standardized meal (524 kcal) in healthy lean males (n = 12) at a University Clinical Research Unit. MAIN OUTCOME MEASURES: We assessed early (30-min) area under the curve (AUC30) of plasma levels of insulin and intact (i......) and total (t) glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) after meal ingestion and made an estimation of beta-cell function by model analysis of glucose and C-peptide. RESULTS: Peak glucose was lower in the morning than in the afternoon (6.1 +/- 0.2 vs. 7.4 +/- 0...

  17. Pharmacokinetic study of five ginsenosides using a sensitive and rapid liquid chromatography-tandem mass spectrometry method following single and multiple oral administration of Shexiang Baoxin pills to rats.

    Science.gov (United States)

    Peng, Chengcheng; Yang, Yongge; Lv, Chao; Jin, Huizi; Tao, Jianfei; Yuan, Xing; Huang, Huimei; Han, Lin; Chang, Wanlin; Liu, Runhui; Zhang, Weidong

    2015-03-01

    Shexiang Baoxin pills (SBP) are a traditional Chinese medicine that are used for treating coronary heart disease. Ginsenosides are the main effective components of SBP, but a comprehensive and deep pharmacokinetic study of ginsenosides in SBP, including multiple dosing and linear or nonlinear properties, is lacking. This study was designed to investigate and compare the pharmacokinetic characteristics of ginsenosides in SBP at a single dose and in multiple doses. A liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed for the simultaneous determination of the ginsenosides Rg1, Re, Rb3, Rc and Rb1 in rat plasma. Rats were randomly assigned to receive a single dose of 4, 8 or 12 g/kg and multiple doses (4 g/kg) of SBP for 8, 15 or 22 consecutive days. The results revealed that ginsenosides, following a single oral dose of 4 or 8 g/kg, were absorbed rapidly, with a Tmax ranging from 0.250 to 1.08 h. The AUC0-t and Cmax of the ppd-type ginsenosides Rb3, Rc and Rb1 were greater than those of the ppt-type ginsenosides Rg1 and Re. Nondose-dependent exposure was observed at doses of 4-12 g/kg for all of the ginsenosides. After multiple dosing, the plasma levels of the ppt-type ginsenosides decreased, whereas those of the ppd-type ginsenosides did not change significantly. In conclusion, the LC-MS/MS method was successfully applied to investigate the pharmacokinetics of ginsenosides after single and multiple oral administrations of SBP. The ginsenosides did not accumulate after multiple dosing. The ppd-type ginsenosides displayed more favorable pharmacokinetic properties compared with the ppt-type ginsenosides. Copyright © 2014 John Wiley & Sons, Ltd.

  18. Percutaneous closure of the left atrial appendage for prevention of thromboembolism in atrial fibrillation for patients with contraindication to or failure of oral anticoagulation: a single-center experience.

    Science.gov (United States)

    Faustino, Ana; Paiva, Luís; Providência, Rui; Trigo, Joana; Botelho, Ana; Costa, Marco; Leitão-Marques, António

    2013-06-01

    In non-valvular atrial fibrillation 90% of thrombi originate in the left atrial appendage (LAA). Percutaneous LAA closure has been shown to be non-inferior to warfarin for prevention of thromboembolism. To evaluate the initial experience of a single center in percutaneous LAA closure in patients with high thromboembolic risk and in whom oral anticoagulation was impractical or contraindicated or had failed. Patients with non-valvular atrial fibrillation and CHADS2 score ≥2 in whom oral anticoagulation was impractical or contraindicated or had failed underwent percutaneous LAA closure according to the standard technique. After the procedure, dual antiplatelet therapy was maintained for one month, followed by single antiplatelet therapy indefinitely. Patients were followed by clinical assessment and transthoracic and transesophageal echocardiography. The procedure was performed in 22 of the 23 selected patients (95.7%), mean age 70±9 years, CHADS2 score 3.2±0.9 and CHA2DS2-VASC score 4.7±1.4. Intraprocedural device replacement was necessary only in the first patient, due to oversizing. The following periprocedural complications were observed: one femoral pseudoaneurysm, three femoral hematomas and two minor oropharyngeal bleeds, resolved by local hemostatic measures. During a 12±8 month follow-up a mild peri-device flow and a thrombus adhering to the device, resolved under with enoxaparin therapy, were identified. The rate of transient ischemic attack (TIA)/stroke was lower than expected according to the CHADS2 score (0 vs. 6.7±2.2%). In our initial experience, this procedure proved to be a feasible, safe and effective alternative for atrial fibrillation patients in whom oral anticoagulation is not an option. Only relatively minor complications were observed, with a lower than expected TIA/stroke rate. Copyright © 2012 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

  19. Single oral doses of netazepide (YF476), a gastrin receptor antagonist, cause dose-dependent, sustained increases in gastric pH compared with placebo and ranitidine in healthy subjects.

    Science.gov (United States)

    Boyce, M; David, O; Darwin, K; Mitchell, T; Johnston, A; Warrington, S

    2012-07-01

    Nonclinical studies have shown netazepide (YF476) to be a potent, selective, competitive and orally active gastrin receptor antagonist. To administer to humans for the first time single oral doses of netazepide, to assess their tolerability, safety, pharmacokinetics and effect on 24-h gastric pH. We did two randomised double-blind single-dose studies in healthy subjects. The first (n = 12) was a six-way incomplete crossover pilot study of rising doses of netazepide (range 0.5-100 mg) and placebo. The second (n = 20) was a five-way complete crossover study of netazepide 5, 25 and 100 mg, ranitidine 150 mg and placebo. In both trials we collected frequent blood samples, measured plasma netazepide and calculated pharmacokinetic parameters. In the comparative trial we measured gastric pH continuously for 24 h and compared treatments by percentage time gastric pH ≥4. Netazepide was well tolerated. Median t (max) and t (½) for the 100 mg dose were about 1 and 7 h, respectively, and the pharmacokinetics were dose-proportional. Netazepide and ranitidine each increased gastric pH. Onset of activity was similarly rapid for both. All netazepide doses were more effective than placebo (P ≤ 0.023). Compared with ranitidine, netazepide 5 mg was as effective, and netazepide 25 and 100 mg were much more effective (P ≤ 0.010), over the 24 h after dosing. Activity of ranitidine lasted about 12 h, whereas that of netazepide exceeded 24 h. In human: netazepide is an orally active gastrin antagonist, and gastrin has a major role in controlling gastric acidity. Repeated-dose studies are justified. NCT01538784 and NCT01538797. © 2012 Blackwell Publishing Ltd.

  20. Interactive effects of sleep duration and morning/evening preference on cardiovascular risk factors.

    Science.gov (United States)

    Patterson, Freda; Malone, Susan Kohl; Grandner, Michael A; Lozano, Alicia; Perkett, Mackenzie; Hanlon, Alexandra

    2018-02-01

    Sleep duration and morningness/eveningness (circadian preference) have separately been associated with cardiovascular risk factors (i.e. tobacco use, physical inactivity). Interactive effects are plausible, resulting from combinations of sleep homeostatic and circadian influences. These have not been examined in a population sample. Multivariable regression models were used to test the associations between combinations of sleep duration (short [≤6 h], adequate [7-8 h], long [≥9 h]) and morning/evening preference (morning, somewhat morning, somewhat evening, evening) with the cardiovascular risk factors of tobacco use, physical inactivity, high sedentary behaviour, obesity/overweight and eating fewer than 5 daily servings of fruit and vegetables, in a cross-sectional sample of 439 933 adults enrolled in the United Kingdom Biobank project. Participants were 56% female, 95% white and mean age was 56.5 (SD = 8.1) years. Compared with adequate sleep with morning preference (referent group), long sleep with evening preference had a relative odds of 3.23 for tobacco use, a 2.02-fold relative odds of not meeting physical activity recommendations, a 2.19-fold relative odds of high screen-based sedentary behaviour, a 1.47-fold relative odds of being obese/overweight and a 1.62-fold relative odds of morning or somewhat morning preference was associated with a lower prevalence and odds for all cardiovascular risk behaviours except fruit and vegetable intake. Long sleepers with evening preference may be a sleep phenotype at high cardiovascular risk. Further work is needed to examine these relationships longitudinally and to assess the effects of chronotherapeutic interventions on cardiovascular risk behaviours. © The Author 2017. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

  1. Sex differences in morning cortisol in youth at ultra-high-risk for psychosis.

    Science.gov (United States)

    Carol, Emily E; Spencer, Robert L; Mittal, Vijay A

    2016-10-01

    Research suggests abnormalities in hypothalamic-pituitary-adrenal (HPA) axis function play an important role in the pathophysiology of psychosis. However, there is limited research on the biological stress system in young people at ultra high risk (UHR) for psychosis. Morning cortisol levels are particularly relevant to study in this context, as these markers reflect HPA regulation. This is the first examination of sex differences in morning cortisol levels in UHR individuals. Twenty-eight UHR and 22 matched healthy control participants were assessed in respect to symptoms and had home-based collection of salivary cortisol over three time points in the morning. It was predicted that the UHR participants would exhibit lower morning cortisol levels and lower cortisol would be associated with greater symptomatology (i.e. higher positive, negative, and depressive symptoms). Additionally, sex differences in morning cortisol levels were explored based on recent evidence suggesting that sex differences may play an important role in the exacerbation of psychosis. While there were no group differences in morning salivary cortisol secretion, there was a sex by time interaction among UHR individuals, such that only UHR males exhibited flat cortisol levels across two hours after awakening, whereas UHR females had a pattern of cortisol secretion similar to healthy controls, even among medication-free individuals (F=6.34, p=0.004). Cortisol AUC (area under the curve) across the three time points had a trend association (medium effect size; r=0.34, p=0.08) with depressive, but not positive or negative, symptom severity. These results stress the importance of considering sex differences in the psychosis-risk period, as they improve understanding of pathogenic processes. Published by Elsevier Ltd.

  2. Morning hypertension and night non-dipping in patients with diabetes and chronic kidney disease.

    Science.gov (United States)

    Oh, Se Won; Han, Sang Youb; Han, Kum Hyun; Cha, Ran-hui; Kim, Sejoong; Yoon, Sun Ae; Rhu, Dong-Ryeol; Oh, Jieun; Lee, Eun Young; Kim, Dong Ki; Kim, Yon Su

    2015-12-01

    Morning hypertension (HTN) and nocturnal non-dipping (ND) are closely associated with target organ damage and cardiovascular events. However, their importance in diabetics with advanced renal disease is unclear. We evaluated the relationships of morning HTN and ND with estimated glomerular filtration rate (eGFR) and proteinuria, and determined the risk of morning HTN and ND according to presence of diabetes mellitus (DM) and chronic kidney disease (CKD) stage. A total of 1312 patients, including 439 with diabetes, were prospectively recruited at 21 centers in Korea. All patients had HTN and an eGFR of 15-89 ml min(-1) per 1.73 m(2). Ambulatory 24-h blood pressure was assessed. The rates of morning HTN (25.2% vs. 13.6%, Pmorning HTN only in non-diabetics (P=0.005). Proteinuria was related to ND in all patients (Pmorning HTN only in diabetics (P=0.001). In a regression analysis, the risk of morning HTN was 2.093 (95% confidence interval (95% CI): 1.070-4.094) for the DMCKD2 group, 1.634 (95% CI: 1.044-2.557) for the CKD3-4-only group and 2.236 (95% CI: 1.401-3.570) for the DMCKD3-4 group compared with the CKD2-only group. The risk of ND was high for stage 3-4 CKD: 1.581 (95% CI: 1.180-2.120) for non-diabetics and 1.842 (95% CI: 1.348-2.601) for diabetics. Diabetics showed higher rates of morning HTN, ND and uncontrolled sustained HTN compared with non-diabetics with CKD of the same stages.

  3. Quality of Morning Report at Yazd Shahid Sadoughi Teaching Hospital in 1386

    Directory of Open Access Journals (Sweden)

    S Zare

    2008-01-01

    Full Text Available ackground : Morning report has been the basis of educational programs for internal residents over years. It consists of various groups including instructors, trainers, and students with varying educational objectives. Yet, there is no uniform pattern for this purpose. So, the present study was conducted to evaluate the quality of morning report at Yazd Shahid Sadoughi Teaching Hospital. Methods : This was a descriptive cross-sectional study carried out on a total of 117 subjects (37 males, and 80 females including 39 assistant students, 39 attending students, and 39 trainees in the Internal Medicine, Pediatrics, and Obstetrics Wards. A questionnaire including 29 items was given to the students to survey the quality of morning report in different wards. The related data were collected and analyzed using Chi-square. Each questionnaire was scored on the basis of a predetermined criterion measure. The data were classified into "excellent" and "moderate" groups. Results : No statistically significant difference was found between questionnaire score and sex (P-value = 0.05 yet, there was a statistically significant difference between questionnaire scores relating to the three said wards (P-value = 0.019. The obstetrics ward (48% was at the excellent level. 22.2% of the students presented their morning reports including a follow-up. 55.6% of the students presented their reports at the assistant level. 66.7% of the students presented their report in the form of question-and-answer, while 33.3% of them presented it as a speech. Further, 66.3% of the students maintained that the morning report has had an effective impact on the management of the patients. Conclusion : Based on the findings, it is advisable to provide evidence as films, papers, books, etc. to promote the quality of morning report.

  4. Oral cancer trends in a single head-and-neck cancer center in the Netherlands; decline in T-stage at the time of admission.

    Science.gov (United States)

    Weijers, Manon; Leemans, C René; Aartman, Irene H; Karagozoglu, K Hakki; van der Waal, Isaäc

    2011-11-01

    In this study we evaluated the possible epidemiologic changes of oral cancer patients in the Netherlands between the years 1980-1984 and 2000-2004. We specifically studied the differences in male-female ratio, age, TNM-stage, site distribution, and alcohol and tobacco use. Patients from the VU University Medical Center with an oral squamous cell carcinoma of the oral cavity registered in 1980-1984 (n=200), group 1, were compared to patients registered in 2000-2004 (n=184), group 2. Trends in prevalence, site distribution, TNM-stage, alcohol and tobacco use, age and gender were studied. The male-female ratio has decreased from 1.8 to 1.2. There were no differences in age between the two groups of patients. The site distribution was similar in both groups. The most commonly involved sites were the tongue and the floor of mouth. In group 2 more patients were diagnosed with a T1 tumour. There were no differences in tobacco use between the two different groups. There were much more light drinkers (0-2 drinks per day) in group 2 than in group 1, whereas there were more heavy drinkers (>4 per day) in group 1 than in group 2 (p<0.001). This was observed in both male and female patients. In our study there were no significant differences between the patients registered in the years 1980-1984 and 2000-2004 regarding the mean age of the patients, site distribution and smoking habits. The male-female ratio has decreased. In the recent group more patients were staged T1N0 and there was a strong decrease of the patients who were heavy drinkers.

  5. Association of morning and evening blood pressure at home with asymptomatic organ damage in the J-HOP Study.

    Science.gov (United States)

    Hoshide, Satoshi; Kario, Kazuomi; Yano, Yuichiro; Haimoto, Hajime; Yamagiwa, Kayo; Uchiba, Kiyoshi; Nagasaka, Shoichiro; Matsui, Yoshio; Nakamura, Akira; Fukutomi, Motoki; Eguchi, Kazuo; Ishikawa, Joji

    2014-07-01

    Several guidelines recommend that home blood pressure (HBP) be measured both in the morning and in the evening. However, there have been fewer reports about the clinical significance of morning HBP than about the clinical significance of evening HBP. Our study included 4,310 patients recruited for the Japan Morning Surge Home Blood Pressure Study who had one or more cardiovascular risk factors. We measured morning and evening HBP, urinary albumin-creatinine ratio (UACR), left ventricular mass index (LVMI), brachial-ankle pulse wave velocity (baPWV), maximum carotid intima media thickness (IMT), N-terminal pro-brain-type natriuretic peptide (NT-proBNP), and high-sensitivity cardiac troponin T (Hs-cTnT). The correlation coefficients for the associations between morning systolic BP (SBP) and log-transformed baPWV, NT-proBNP, or Hs-cTnT were significantly greater than the corresponding relationships for evening SBP (all P morning home SBP and UACR (P morning home SBP to the SBP measurement. Morning BP and evening BP provide equally useful information for subclinical target organ damage, yet multivariate modeling highlighted the stand-alone predictive ability of morning BP. © American Journal of Hypertension, Ltd 2014. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  6. Effect of desloratadine on the control of morning symptoms in patients with seasonal and perennial allergic rhinitis.

    Science.gov (United States)

    Schenkel, Eric J

    2006-01-01

    The symptoms of allergic rhinitis vary in severity over the course of the day and often are worse in the morning. This review focuses on data from clinical studies of the antihistamine desloratadine to establish whether it effectively controls the morning symptoms of allergic rhinitis. Studies of desloratadine in patients with allergic rhinitis that used instantaneous scoring to assess the severity of morning symptoms were selected for inclusion from published literature (peer-reviewed articles and abstracts presented at professional meetings). When administered once daily, desloratadine is effective in alleviating the morning symptoms of allergic rhinitis, including nasal congestion. Its action is sustained over the 24-hour dosing interval. A comparison of morning and evening dosing of desloratadine revealed equivalent relief of morning symptoms, illustrating that the effect of desloratadine is independent of the time of dosing. Clinical studies indicate that desloratadine is nonsedating and well tolerated, with no evidence of adverse cardiac effects. For many patients with allergic rhinitis, symptoms are most severe in the morning. To maximize the benefits for patients, pharmacologic agents used in the management of allergic rhinitis should be effective in controlling these peak morning symptoms. The sustained 24-hour action of desloratadine and its effective control of morning symptoms make it a valuable tool for improving the quality of life of patients with allergic rhinitis.

  7. Agreement of pesticide biomarkers between morning void and 24-h urine samples from farmers and their children.

    Science.gov (United States)

    Scher, Deanna P; Alexander, Bruce H; Adgate, John L; Eberly, Lynn E; Mandel, Jack S; Acquavella, John F; Bartels, Michael J; Brzak, Kathy A

    2007-07-01

    In pesticide biomonitoring studies, researchers typically collect either single voids or daily (24-h) urine samples. Collection of 24-h urine samples is considered the "gold-standard", but this method places a high burden on study volunteers, requires greater resources, and may result in misclassification of exposure or underestimation of dose due to noncompliance with urine collection protocols. To evaluate the potential measurement error introduced by single void samples, we present an analysis of exposure and dose for two commonly used pesticides based on single morning void (MV) and 24-h urine collections in farmers and farm children. The agreement between the MV concentration and its corresponding 24-h concentration was analyzed using simple graphical and statistical techniques and risk assessment methodology. A consistent bias towards overprediction of pesticide concentration was found among the MVs, likely in large part due to the pharmacokinetic time course of the analytes in urine. These results suggest that the use of single voids can either over- or under-estimate daily exposure if recent pesticide applications have occurred. This held true for both farmers as well as farm children, who were not directly exposed to the applications. As a result, single void samples influenced the number of children exposed to chlorpyrifos whose daily dose estimates were above levels of toxicologic significance. In populations where fluctuations in pesticide exposure are expected (e.g., farm families), the pharmacokinetics of the pesticide and the timing of exposure events and urine collection must be understood when relying on single voids as a surrogate for longer time-frames of exposure.

  8. Oral histoplasmosis

    Directory of Open Access Journals (Sweden)

    Patil Karthikeya

    2009-01-01

    Full Text Available Histoplasmosis is a systemic fungal disease that takes various clinical forms, among which oral lesions are rare. The disseminated form of the disease that usually occurs in association with Human Immunodeficiency Virus (HIV is one of the AIDS-defining diseases. Isolated oral histoplasmosis, without systemic involvement, with underlying immunosuppression due to AIDS is very rare. We report one such case of isolated oral histoplasmosis in a HIV-infected patient.

  9. The impact of park development on the lives of local inhabitants within Gros Morne National Park

    Science.gov (United States)

    Margot Herd; Paul. Heintzman

    2012-01-01

    The creation of a national park changes the local community's relationship to the land. In 1973, Parks Canada created Gros Morne National Park around existing communities and only relocated a small number of inhabitants to nearby communities. While park creation placed some restrictions on traditional activities, compromises were made to allow the continuation of...

  10. Historia Sancti Ludgeri edited by Morné Bezuidenhout: a new ...

    African Journals Online (AJOL)

    The Historia Sancti Ludgeri, edited by Morné Bezuidenhout, appeared recently as part of the Historia series of the Cantus Planus Group of the International Musicological Society. Manuscript Grey 4.b.5, a composite breviary and antiphonal that is at present in the Grey Collection in Cape Town, contains the complete rhymed ...

  11. Strengthening German Programs through Community Engagement and Partnerships with Saturday Morning Schools

    Science.gov (United States)

    Hellebrandt, Josef

    2014-01-01

    German university programs can increase enrollments and diversify their curricula through academic community partnerships with surrounding schools. This article informs about two community-supported initiatives between the German Studies Program at Santa Clara University and the South Bay Deutscher Schulverein, a Saturday Morning School in…

  12. The Relationship between Snoring Sound Intensity and Morning Blood Pressure in Workers.

    Science.gov (United States)

    Furukawa, Tomokazu; Nakano, Hiroshi; Yoshihara, Kazufumi; Sudo, Nobuyuki

    2016-12-15

    This study aimed to determine the consequences of snoring independent of obstructive sleep apnea (OSA) and hypothesized that snoring sound intensity, as assessed by mean tracheal sound (TS) energy (Leq), is related to morning blood pressure (BP). A home-based TS monitoring study was performed for two nights on 191 workers in Japan using an IC recorder. Leq and the respiratory disturbance index (RDI) were calculated from the TS data. RDI was used as a marker of OSA severity. Systolic and diastolic BP measurements in the evening and morning (eSBP/eDBP and mSBP/mDBP, respectively) were done before and after TS recording. The data of the second night were analyzed. Leq was significantly related to both mSBP and mDBP (r = 0.32, p morning BP after adjustment for age, sex, and body mass index. However, the relationship was no longer significant when both RDI and Leq were included in the multiple regression model. In non-apneic, non-obese subjects, Leq was significantly related to both mSBP and mDBP (r = 0.38, p morning BP suggests a pathological role of heavy snoring. To understand this association, a prospective cohort study in a general population is warranted. A commentary on this article appears in this issue on page 1581. © 2016 American Academy of Sleep Medicine

  13. Treatment of asthma by the inhaled corticosteroid ciclesonide given either in the morning or evening

    NARCIS (Netherlands)

    Postma, DS; Sevette, C; Martinat, Y; Schlosser, N; Aumann, J; Kafe, H

    The study addressed the question whether the novel inhaled prodrug corticosteroid ciclesonide is equally effective when inhaled in the morning compared to the evening. For this purpose a double-blind, randomized, parallel group study was initiated in which 209 asthmatic patients (forced expiratory

  14. Effects of Evening vs Morning Levothyroxine Intake A Randomized Double-blind Crossover Trial

    NARCIS (Netherlands)

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

    2010-01-01

    Background: 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

  15. First Morning Voids Are More Reliable Than Spot Urine Samples to Assess Microalbuminuria

    NARCIS (Netherlands)

    Witte, Elsbeth C.; Lambers Heerspink, Hiddo J.; de Zeeuw, Dick; Bakker, Stephan J. L.; de Jong, Paul E.; Gansevoort, Ronald

    Measurement of urinary albumin excretion (UAE) in a 24-h collection is the gold standard method to determine the presence of microalbuminuria. We sought to compare more practical alternatives-measurement of urinary albumin concentration (UAC) or albumin:creatinine ratio (ACR)-in a first morning void

  16. Legal drug content in music video programs shown on Australian television on saturday mornings.

    Science.gov (United States)

    Johnson, Rebecca; Croager, Emma; Pratt, Iain S; Khoo, Natalie

    2013-01-01

    To examine the extent to which legal drug references (alcohol and tobacco) are present in the music video clips shown on two music video programs broadcast in Australia on Saturday mornings. Further, to examine the music genres in which the references appeared and the dominant messages associated with the references. Music video clips shown on the music video programs 'Rage' (ABC TV) and [V] 'Music Video Chart' (Channel [V]) were viewed over 8 weeks from August 2011 to October 2011 and the number of clips containing verbal and/or visual drug references in each program was counted. The songs were classified by genre and the dominant messages associated with drug references were also classified and analysed. A considerable proportion of music videos (approximately one-third) contained drug references. Alcohol featured in 95% of the music videos that contained drug references. References to alcohol generally associated it with fun and humour, and alcohol and tobacco were both overwhelmingly presented in contexts that encouraged, rather than discouraged, their use. In Australia, Saturday morning is generally considered a children's television viewing timeslot, and several broadcaster Codes of Practice dictate that programs shown on Saturday mornings must be appropriate for viewing by audiences of all ages. Despite this, our findings show that music video programs aired on Saturday mornings contain a considerable level of drug-related content.

  17. Calcipotriol cream in the morning and ointment in the evening: a novel regimen to improve compliance.

    NARCIS (Netherlands)

    Kerkhof, P.C.M. van de; Franssen, M.; Brassinne, M. de la; Kuipers, M.V.

    2001-01-01

    BACKGROUND: Calcipotriol ointment and calcipotriol cream have both been shown to be effective in the treatment of psoriasis. AIM: To find out the patient compliance, efficacy and tolerance to a regimen of a calcipotriol cream application in the morning and a calcipotriol ointment application in the

  18. Prognostic value of the morning blood pressure surge in 5645 subjects from 8 populations

    DEFF Research Database (Denmark)

    Li, Yan; Thijs, Lutgarde; Hansen, Tine W

    2010-01-01

    Previous studies on the prognostic significance of the morning blood pressure surge (MS) produced inconsistent results. Using the International Database on Ambulatory Blood Pressure in Relation to Cardiovascular Outcome, we analyzed 5645 subjects (mean age: 53.0 years; 54.0% women) randomly recru...

  19. Self-awakening improves alertness in the morning and during the day after partial sleep deprivation.

    Science.gov (United States)

    Ikeda, Hiroki; Kubo, Tomohide; Kuriyama, Kenichi; Takahashi, Masaya

    2014-12-01

    The ability to awaken at a predetermined time without an alarm is known as self-awakening. Self-awakening improves morning alertness by eliminating sleep inertia; however, the effects of self-awakening on daytime alertness and alertness that has deteriorated as a result of sleep loss are unknown. The aim of this study was to determine the effects of self-awakening on both morning and daytime alertness after partial sleep deprivation. Fifteen healthy males without the habit of self-awakening participated in a cross-over trial including forced awakening and self-awakening conditions. In each condition, participants' sleep was restricted to 5 h per night in their homes for 4 consecutive days. They completed a psychomotor vigilance task and subjective ratings of sleepiness immediately upon awakening each morning. On the fourth day, participants completed subjective ratings of sleepiness, a psychomotor vigilance task and sleep latency tests in the laboratory seven times at 1-h intervals during the day. The response speed on the psychomotor vigilance task, in the morning and during the day, was higher in the self-awakening than the forced awakening condition. Our results showed that self-awakening improved alertness (assessed by response speeds) by reducing sleep inertia and alleviated daytime sleepiness heightened by partial sleep deprivation. © 2014 European Sleep Research Society.

  20. Reevaluation of the role of duration of morning stiffness in the assessment of rheumatoid arthritis activity

    DEFF Research Database (Denmark)

    Khan, Nasim A; Yazici, Yusuf; Calvo-Alen, Jaime

    2009-01-01

    OBJECTIVE: To evaluate the utility of the duration of morning stiffness (MS), as a patient-reported outcome (PRO), in assessing rheumatoid arthritis (RA) disease activity. METHODS: We acquired information on 5439 patients in QUEST-RA, an international database of patients with RA evaluated by a s...

  1. Can neck irradiation be an alternative to neck dissection in early stage carcinoma oral tongue operated for primary alone? Experience from a single institute

    Directory of Open Access Journals (Sweden)

    Sushmita Ghoshal

    2016-07-01

    Full Text Available Purpose: To study pattern of failure, locoregional control rates (LCR and disease free survival (DFS in post-operative patients of carcinoma oral tongue, and to study the impact of nodal dissection on DFS in stage I and II patients.Methods: 102 patients of carcinoma oral tongue treated between January 2009 and December 2013 were analyzed. All patients were operated for primary disease, but neck dissection was done in 78 (76.5% patients only. However, radiation to primary site along with neck region was received by all patients. Pattern of failure, LCR and DFS were estimated.Results: At median follow up of 12 months, 10.8% patients failed locally, 10.8% in nodal region, 2.9% both at local and nodal site, and 5.9% patients failed distally. 2 year LCR and DFS was 71.2%, 90.9%, 79.5%, 0% and 55.2%, 64.4%, 57.8%, 0% in stage I, II, III, IV respectively. 2 year DFS in stage I patients, who underwent nodal dissection and post-operative radiation (14 patients was 64.3% and in whom only neck irradiation was done (15 patients, it was 45.8%, however difference was not significant (p = 0.5. But in stage II patients, 33 patients who underwent nodal dissection and post-operative radiation, 2 year DFS was 85.4% and it was 21.4% in 7 patients who underwent neck radiation only, and difference showed trend towards significance (p = 0.05. 2 or more positive lymph nodes post dissection was the only poor prognostic factor that correlated with DFS (p = 0.02Conclusion: While in stage I, neck irradiation alone can be a possible alternative to neck dissection and post-operative radiation; for stage II, neck dissection is mandatory.

  2. 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).

  3. Nighttime feeding likely alters morning metabolism but not exercise performance in female athletes.

    Science.gov (United States)

    Ormsbee, Michael J; Gorman, Katherine A; Miller, Elizabeth A; Baur, Daniel A; Eckel, Lisa A; Contreras, Robert J; Panton, Lynn B; Spicer, Maria T

    2016-07-01

    The timing of morning endurance competition may limit proper pre-race fueling and resulting performance. A nighttime, pre-sleep nutritional strategy could be an alternative method to target the metabolic and hydrating needs of the early morning athlete without compromising sleep or gastrointestinal comfort during exercise. Therefore, the purpose of this investigation was to examine the acute effects of pre-sleep chocolate milk (CM) ingestion on next-morning running performance, metabolism, and hydration status. Twelve competitive female runners and triathletes (age, 30 ± 7 years; peak oxygen consumption, 53 ± 4 mL·kg(-1)·min(-1)) randomly ingested either pre-sleep CM or non-nutritive placebo (PL) ∼30 min before sleep and 7-9 h before a morning exercise trial. Resting metabolic rate (RMR) was assessed prior to exercise. The exercise trial included a warm-up, three 5-min incremental workloads at 55%, 65%, and 75% peak oxygen consumption, and a 10-km treadmill time trial (TT). Physiological responses were assessed prior, during (incremental and TT), and postexercise. Paired t tests and magnitude-based inferences were used to determine treatment differences. TT performances were not different ("most likely trivial" improvement with CM) between conditions (PL: 52.8 ± 8.4 min vs CM: 52.8 ± 8.0 min). RMR was "likely" increased (4.8%) and total carbohydrate oxidation (g·min(-1)) during exercise was "possibly" or likely increased (18.8%, 10.1%, 9.1% for stage 1-3, respectively) with CM versus PL. There were no consistent changes to hydration indices. In conclusion, pre-sleep CM may alter next-morning resting and exercise metabolism to favor carbohydrate oxidation, but effects did not translate to 10-km running performance improvements.

  4. Morning and Evening Blue-Enriched Light Exposure Alters Metabolic Function in Normal Weight Adults

    Science.gov (United States)

    Cheung, Ivy N.; Zee, Phyllis C.; Shalman, Dov; Malkani, Roneil G.; Kang, Joseph; Reid, Kathryn J.

    2016-01-01

    Increasing evidence points to associations between light-dark exposure patterns, feeding behavior, and metabolism. This study aimed to determine the acute effects of 3 hours of morning versus evening blue-enriched light exposure compared to dim light on hunger, metabolic function, and physiological arousal. Nineteen healthy adults completed this 4-day inpatient protocol under dim light conditions (morning group) or 10.5 hours after wake (n = 10; evening group). All participants remained in dim light on Day 2 to serve as their baseline. Subjective hunger and sleepiness scales were collected hourly. Blood was sampled at 30-minute intervals for 4 hours in association with the light exposure period for glucose, insulin, cortisol, leptin, and ghrelin. Homeostatic model assessment of insulin resistance (HOMA-IR) and area under the curve (AUC) for insulin, glucose, HOMA-IR and cortisol were calculated. Comparisons relative to baseline were done using t-tests and repeated measures ANOVAs. In both the morning and evening groups, insulin total area, HOMA-IR, and HOMA-IR AUC were increased and subjective sleepiness was reduced with blue-enriched light compared to dim light. The evening group, but not the morning group, had significantly higher glucose peak value during blue-enriched light exposure compared to dim light. There were no other significant differences between the morning or the evening groups in response to blue-enriched light exposure. Blue-enriched light exposure acutely alters glucose metabolism and sleepiness, however the mechanisms behind this relationship and its impacts on hunger and appetite regulation remain unclear. These results provide further support for a role of environmental light exposure in the regulation of metabolism. PMID:27191727

  5. Selecting the patients for morning report sessions: case-based vs. conventional method.

    Science.gov (United States)

    Rabiei, Mehdi; Saeidi, Masumeh; Kiani, Mohammad Ali; Amin, Sakineh Mohebi; Ahanchian, Hamid; Jafari, Seyed Ali; Kianifar, Hamidreza

    2015-08-01

    One of the most important issues in morning report sessions is the number of patients. The aim of this study was to investigate and compare the number of cases reported in the morning report sessions in terms of case-based and conventional methods from the perspective of pediatric residents of Mashhad University of Medical Sciences. The present study was conducted on 24 pediatric residents of Mashhad University of Medical Sciences in the academic year 2014-2015. In this survey, the residents replied to a 20-question researcher-made questionnaire that had been designed to measure the views of residents regarding the number of patients in the morning report sessions using case-based and conventional methods. The validity of the questionnaire was confirmed by experts' views and its reliability by calculating Cronbach's alpha coefficients. Data were analyzed by t-test analysis. The mean age of the residents was 30.852 ± 2.506, and 66.6% of them were female. The results showed that there was no significant relationship among the variables of academic year, gender, and residents' perspective to choosing the number of patients in the morning report sessions (P > 0.05). T-test analysis showed a significant relationship among the average scores of residents in the selection of the case-based method in comparison to the conventional method (P case-based morning report was preferred compared to the conventional method. This method makes residents pay more attention to the details of patients' issues and therefore helps them to better plan how to address patient problems and improve their differential diagnosis skills.

  6. Morning and Evening Blue-Enriched Light Exposure Alters Metabolic Function in Normal Weight Adults.

    Science.gov (United States)

    Cheung, Ivy N; Zee, Phyllis C; Shalman, Dov; Malkani, Roneil G; Kang, Joseph; Reid, Kathryn J

    2016-01-01

    Increasing evidence points to associations between light-dark exposure patterns, feeding behavior, and metabolism. This study aimed to determine the acute effects of 3 hours of morning versus evening blue-enriched light exposure compared to dim light on hunger, metabolic function, and physiological arousal. Nineteen healthy adults completed this 4-day inpatient protocol under dim light conditions (blue-enriched light exposure on Day 3 starting either 0.5 hours after wake (n = 9; morning group) or 10.5 hours after wake (n = 10; evening group). All participants remained in dim light on Day 2 to serve as their baseline. Subjective hunger and sleepiness scales were collected hourly. Blood was sampled at 30-minute intervals for 4 hours in association with the light exposure period for glucose, insulin, cortisol, leptin, and ghrelin. Homeostatic model assessment of insulin resistance (HOMA-IR) and area under the curve (AUC) for insulin, glucose, HOMA-IR and cortisol were calculated. Comparisons relative to baseline were done using t-tests and repeated measures ANOVAs. In both the morning and evening groups, insulin total area, HOMA-IR, and HOMA-IR AUC were increased and subjective sleepiness was reduced with blue-enriched light compared to dim light. The evening group, but not the morning group, had significantly higher glucose peak value during blue-enriched light exposure compared to dim light. There were no other significant differences between the morning or the evening groups in response to blue-enriched light exposure. Blue-enriched light exposure acutely alters glucose metabolism and sleepiness, however the mechanisms behind this relationship and its impacts on hunger and appetite regulation remain unclear. These results provide further support for a role of environmental light exposure in the regulation of metabolism.

  7. Comparing Performance During Morning vs. Afternoon Training Sessions in Intercollegiate Basketball Players.

    Science.gov (United States)

    Heishman, Aaron D; Curtis, Michael A; Saliba, Ethan N; Hornett, Robert J; Malin, Steven K; Weltman, Arthur L

    2017-06-01

    Time of day is a key factor that influences the optimization of athletic performance. Intercollegiate coaches oftentimes hold early morning strength training sessions for a variety of factors including convenience. However, few studies have specifically investigated the effect of early morning vs. late afternoon strength training on performance indices of fatigue. This is athletically important because circadian and/or ultradian rhythms and alterations in sleep patterns can affect training ability. Therefore, the purpose of the present study was to examine the effects of morning vs. afternoon strength training on an acute performance index of fatigue (countermovement jump height, CMJ), player readiness (Omegawave), and self-reported sleep quantity. We hypothesized that afternoon training sessions would be associated with increased levels of performance, readiness, and self-reported sleep. A retrospective analysis was performed on data collected over the course of the preseason on 10 elite National Collegiate Athletic Association Division 1 male basketball players. All basketball-related activities were performed in the afternoon with strength and conditioning activities performed either in the morning or in the afternoon. The average values for CMJ, power output (Power), self-reported sleep quantity (sleep), and player readiness were examined. When player load and duration were matched, CMJ (58.8 ± 1.3 vs. 61.9 ± 1.6 cm, p = 0.009), Power (6,378.0 ± 131.2 vs. 6,622.1 ± 172.0 W, p = 0.009), and self-reported sleep duration (6.6 ± 0.4 vs. 7.4 ± 0.25 p = 0.016) were significantly higher with afternoon strength and conditioning training, with no differences observed in player readiness values. We conclude that performance is suppressed with morning training and is associated with a decrease in self-reported quantity of sleep.

  8. Diurnal Fluctuations of Verticality Perception – Lesser Precision Immediately after Waking up in the Morning

    Science.gov (United States)

    Schwarz, Aline J.; Straumann, Dominik; Tarnutzer, Alexander A.

    2015-01-01

    Internal estimates of direction of gravity are continuously updated by integrating vestibular, visual and proprioceptive input, and prior experience about upright position. Prolonged static roll-tilt biases perceived direction of gravity by adaptation of peripheral sensors and central structures. We hypothesized that in the morning after sleep, estimates of direction of gravity [assessed by the subjective visual vertical (SVV)] are less precise than in the evening because of adaptation to horizontal body position and lack of prior knowledge about upright position. Using a mobile SVV-measuring device, verticality perception was assessed in seven healthy human subjects on 7 days in the morning immediately after waking up and in the evening while sitting upright. Paired t-tests were applied to analyze diurnal changes in SVV trial-to-trial variability. Average SVV variability in the morning was significantly larger than in the evening (1.9 ± 0.6° vs. 0.9 ± 0.3°, p = 0.002). SVV accuracy was not significantly different (−1.2 ± 0.9° vs. −0.4 ± 0.4°, morning vs. evening, p = 0.058) and was within normal range (±2.3°) in all but one subject. A good night’s sleep has a profound effect on the brain’s ability to estimate direction of gravity. Resulting variability was significantly worse after waking up reaching values more than twice as large as in the evening while there was no significant impact on SVV accuracy. We hypothesize that lacking prior knowledge, adaptation of peripheral sensors, and lower levels of arousal and cerebral metabolism contribute to such impoverished estimates. Our observations have considerable clinical impact as they indicate an increased risk for falls and fall-related injuries in the morning. PMID:26388837

  9. [Nutritional analysis of breakfast on rising and mid-morning snack in a college population].

    Science.gov (United States)

    Durá Travé, T

    2013-01-01

    To carry out a descriptive study on the breakfast model in a college population and to analyze the energy and nutrients provided, in connection with established nutritional requirements. Registry of food intake for breakfast (on rising and mid-morning snack) of a school day in a sample of 740 college students (286 men and 454 women) with ages ranging 19-24 years. Gender, age, weight, height, and body mass index, and type of residence were collected from each interviewee. Percentages intakes of nutrients have been calculated in proportion to established dietary recommendations (%IR). 93.2% had breakfast on rising and 83.8% took a mid-morning snack daily, and 53.5% do both intakes. The most common foods were dairy products (92.6%), cereals (58.8%) and sweet food (57.9%) at breakfast, and cereals (46.6%), fruits (40.7%) and sausages (34.9%) at mid-morning. The %IR of the calorie intake was 24.4% in males and 24.6% in females (n.s.). The %IR of the cholesterol intake was 38.2% in males and 23.9% in females (p breakfast. This breakfast model differs from the prototype of a healthy diet through an excessive consumption of sweet foods (early breakfast) and meat and derivatives (snack). Half of interviewee did not a mid-morning snack and the morning caloric intake was below recommended. In the case of university students concerned about the potentially negative effect it may have on academic performance. Copyright © AULA MEDICA EDICIONES 2013. Published by AULA MEDICA. All rights reserved.

  10. Effects of timing of prednisolone on the duration of early morning stiffness, pain and disease activity score (das-28) in patients with rheumatoid arthritis

    International Nuclear Information System (INIS)

    Gul, H.; Nasim, A.; Salim, B.

    2017-01-01

    To determine the effects of timing of prednisolone on duration of early morning stiffness, pain score, number of swollen and tender joints, erythrocyte sedimentation rate (ESR) and disease activity score 28 (DAS-28) in joints in patients with rheumatoid arthritis. Study Design: It was quasi experimental study. Place and Duration of Study: This study was conducted in the department of rheumatology Fauji Foundation Hospital Rawalpindi over a period of 3 months, from Dec 2015 to Feb 2016. Material and Methods: Total sample size of 85 was calculated by using non probability consecutive sampling technique. Patients with established rheumatoid arthritis diagnosed on the basis of ACR 1987 criteria were included in the study. All these patients had a disease duration of minimum 6 months and were on disease modifying anti rheumatic drugs and were taking =7.5mg of prednisolone and these patients were treated with the same dose of prednisolone given in morning at 8:00 A.M. for the first 15 days followed by treatment with same single daily dose of prednisolone given at the night 10:00 P.M. for next 15 days. This study compared duration of early morning stiffness, pain scores, number of swollen and tender joints, DAS-28 and ESR on day 15th and day 30th. Results: A total of 85 patients of established rheumatoid arthritis were included in the study. All patients were female with a mean duration of disease of 7.87 +- 6.41 years. The mean age of patients was 49.39 +- 10.24 years. Mean of pain score, duration of morning stiffness, DAS-28, number of tender and swollen joint count, and ESR was decreased in patients who took prednisolone at 10:00 pm and had significant statistical difference (p-value<0.001). Conclusions: Administration of low dose of prednisolone at night has good effects on duration of early morning stiffness, pain scores, number of swollen and tender joints, ESR and DAS-28. (author)

  11. Single blind, randomised trial of efficacy and acceptability of oral picolax versus self administered phosphate enema in bowel preparation for flexible sigmoidoscopy screening.

    Science.gov (United States)

    Atkin, W S; Hart, A; Edwards, R; Cook, C F; Wardle, J; McIntyre, P; Aubrey, R; Baron, C; Sutton, S; Cuzick, J; Senapati, A; Northover, J M

    2000-06-03

    To compare the acceptability and efficacy of two methods of self administered bowel preparation for flexible sigmoidoscopy screening: a single phosphate enema and a single sachet of Picolax. Single blind, randomised trial. Endoscopy units of two general hospitals. 1442 men and women aged 55-64 years who had agreed to be screened by flexible sigmoidoscopy. MAIN OUTCOME MESURESs: Attendance rates, compliance with allocated preparations, adverse effects, quality of bowel preparation, procedure time, and yield of neoplasia. Compliance with the enema was higher than with the Picolax (608 (84%) v 566 (79%); difference 6%, 95% confidence interval 2% to 10%). Almost half of those who refused Picolax used an enema at home. Wind, incontinence, and sleep disturbance were more frequent in the Picolax group than the enema group; bottom soreness was more frequent in the enema group. Around 30% (187) found the diet restriction required by Picolax difficult; 78% (471) found the enema easy to administer. The quality of preparation was better with the enema; the proportion of procedures complete to the descending colon was greater and the mean duration of the procedure was shorter. There was no significant difference in polyp detection rates. A single phosphate enema self administered around one hour before leaving home is a more acceptable and effective method of preparing the distal bowel for flexible sigmoidoscopy than Picolax.

  12. Boundary|Time|Surface: Art and Geology Meet in Gros Morne National Park, NL, Canada

    Science.gov (United States)

    Lancaster, Sydney; Waldron, John

    2015-04-01

    Environmental Art works range in scope from major permanent interventions in the landscape to less intrusive, more ephemeral site-specific installations constructed of materials from the local environment. Despite this range of intervention, however, these works all share in a tradition of art making that situates the artwork in direct response to the surrounding landscape. Andy Goldsworthy and Richard Long, for example, both favour methods that combine elements of both sculpture and performance in the creation of non-permanent interventions in the landscape, and both rely upon photographic, text-based, or video documentation as the only lasting indication of the works' existence. Similarly, Earth Scientists are responsible for interventions in the landscape, both physical and conceptual. For example, in Earth science, the periods of the geologic timescale - Cambrian, Ordovician, Silurian, etc. - were established by 19th century pioneers of geology at a time when they were believed to represent natural chapters in Earth history. Since the mid-20th century, stratigraphers have attempted to resolve ambiguities in the original definitions by defining stratotypes: sections of continuously deposited strata where a single horizon is chosen as a boundary. One such international stratotype, marking the Cambrian-Ordovician boundary, is defined at Green Point in Gros Morne National Park, Newfoundland. Boundary|Time|Surface was an ephemeral sculptural installation work constructed in June 2014. The main installation work was a fence of 52 vertical driftwood poles, 2-3 m tall, positioned precisely along the boundary stratotype horizon at Green Point in Newfoundland. The fence extended across a 150 m wave-cut platform from sea cliffs to the low-water mark, separating Ordovician from Cambrian strata. The installation was constructed by hand (with volunteer assistance) on June 22, as the wave-cut platform was exposed by the falling tide. During the remainder of the tidal cycle

  13. Mood disturbances during combined oral contraceptive use and the effect of androgen supplementation. Results of a double-blind, placebo-controlled, single-case alternation design pilot study.

    Science.gov (United States)

    Roumen, Frans J M E; Zimmerman, Yvette; van Wijck, Annemieke; Ter Kuile, Moniek M; Onghena, Patrick; Coelingh Bennink, Herjan J T

    2017-04-01

    To evaluate the effect of androgen supplementation in healthy combined oral contraceptive (COC) users who experience mood disturbances during COC-use only. Six women with mood disturbances during COC-use only, received COC with co-treatment of 50 mg dehydroepiandrosterone (DHEA) during three cycles and placebo during another three cycles in an individualized random order. Daily mood rating was measured by a single item: 'In what kind of mood have you been in the past 24 h?' The results were analysed using a randomisation test for single-case experimental designs. The p values for the alternation design randomisation tests on the raw data of the six healthy individuals varied between 0.21 and 1, indicating that the average daily mood ratings of the active treatment DHEA are not statistically significantly larger than the average daily mood ratings of placebo. The combined p value of the subjects using a DRSP-containing pill was 0.97, and of the subjects using an LNG-containing pill was 0.65, indicating no statistically significant treatment effect for any of the pill types. In this single-case alternation design study, concomitant treatment with DHEA for intermittent periods of 4 weeks did not result in improvement of mood disturbances related to COC-use, but had also no side-effects.

  14. The importance of assessment and management of morning stiffness in Asian patients with rheumatoid arthritis: Recommendations from an expert panel.

    Science.gov (United States)

    Mok, Chi Chiu; Cha, Hoon Suk; Hidayat, Rudy; Nguyen, Lan Thi Ngoc; Perez, Emmanuel C; Ramachandran, Raveendran; Tsay, Gregory J; Yoo, Dae Hyun

    2016-01-01

    In patients with rheumatoid arthritis (RA), morning stiffness is linked more to functional disability and pain than disease activity, as assessed by joint counts and markers of inflammation. As part of the Asia Pacific Morning Stiffness in Rheumatoid Arthritis Expert Panel, a group of eight rheumatologists met to formulate consensus points and develop recommendations for the assessment and management of morning stiffness in RA. On the basis of a systematic literature review and expert opinion, a panel of Asian rheumatologists formulated recommendations for the assessment and medical treatment of RA. The panel agreed upon 10 consensus statements on morning stiffness, its assessment and treatment. Specifically, the panel recommended that morning stiffness, pain and impaired morning function should be routinely assessed in clinical practice. Although there are currently no validated tools for these parameters, they should be assessed as part of the patients' reported outcomes in RA. The panel also agreed on the benefits of low-dose glucocorticoids in RA, particularly for the improvement of morning stiffness. These recommendations serve to guide rheumatologists and other stakeholders on the assessment and management of morning stiffness, and help implement the treat-to-target principle in the management of RA. © 2015 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

  15. Morning and Evening Blood Pressures Are Associated With Intima-Media Thickness in a General Population - The Hisayama Study.

    Science.gov (United States)

    Sakata, Satoko; Hata, Jun; Fukuhara, Masayo; Yonemoto, Koji; Mukai, Naoko; Yoshida, Daigo; Kishimoto, Hiro; Ohtsubo, Toshio; Kitazono, Takanari; Kiyohara, Yutaka; Ninomiya, Toshiharu

    2017-10-25

    The association of morning and evening home blood pressures (HBPs) with carotid atherosclerosis has been uncertain in general populations, so we aimed to investigate it in a general Japanese population.Methods and Results:We performed a cross-sectional survey of 2,856 community-dwelling individuals aged ≥40 years to examine the association of morning and evening HBPs with carotid mean intima-media thickness (IMT). The age- and sex-adjusted geometric averages of carotid mean IMT increased significantly with increasing morning HBP (optimal: 0.67 mm; normal: 0.69 mm; high normal: 0.72 mm; grade 1 hypertension: 0.74 mm; and grade 2+3 hypertension: 0.76 mm) and with increasing evening HBP (0.68 mm, 0.71 mm, 0.73 mm, 0.76 mm, and 0.78 mm, respectively) (both P for trend morning hypertension (morning HBP ≥135/85 mmHg and evening HBP morning HBP morning and evening HBP ≥135/85 mmHg) were significantly associated with thicker mean IMT. Our findings suggested that both morning and evening HBPs were significantly associated with carotid atherosclerosis in this general Japanese population.

  16. The concentrations of clinafloxacin in alveolar macrophages, epithelial lining fluid, bronchial mucosa and serum after administration of single 200 mg oral doses to patients undergoing fibre-optic bronchoscopy.

    Science.gov (United States)

    Honeybourne, D; Andrews, J M; Cunningham, B; Jevons, G; Wise, R

    1999-01-01

    The concentrations of clinafloxacin were measured in serum, bronchial mucosa, alveolar macrophages and epithelial lining fluid after single 200 mg oral doses of clinafloxacin had been administered to 15 subjects who were undergoing bronchoscopy. Concentrations were measured using a microbiological assay method. Mean concentrations in serum, bronchial mucosa, alveolar macrophages and epithelial lining fluid at a mean of 1.27 h post-dose were 1.54, 2.65, 15.60 and 2.71 mg/L respectively. These site concentrations exceeded the MIC90 for common respiratory pathogens and indicate that clinafloxacin is likely to be effective in the treatment of a wide range of respiratory tract infections.

  17. Oral administration of choline does not affect metabolic characteristics of gliomas and normal-appearing white matter, as detected with single-voxel 1H-MRS at 1.5 T

    International Nuclear Information System (INIS)

    Chernov, Mikhail F.; Iseki, Hiroshi; Takakura, Kintomo; Muragaki, Yoshihiro; Maruyama, Takashi; Ono, Yuko; Usukura, Masao; Yoshida, Shigetoshi; Nakamura, Ryoichi; Kubo, Osami; Hori, Tomokatsu

    2009-01-01

    The present study was done for evaluation of the possible influence of the oral administration of choline on metabolic characteristics of gliomas detected with proton magnetic resonance spectroscopy ( 1 H-MRS). Thirty patients (22 men and eight women; mean age 38±15 years) with suspicious intracranial gliomas underwent single-voxel long-echo (TR 2,000 ms, TE 136 ms, 128-256 acquisitions) 1 H-MRS of the tumor, peritumoral brain tissue, and distant normal-appearing white matter before and several hours (median, 3 h; range, 1.2-3.7 h) after ingestion of choline with prescribed dose of 50 mg/kg (median actual dose, 52 mg/kg; range, 48-78 mg/kg). Investigations were done using 1.5 T clinical magnetic resonance imager. The volume of the rectangular 1 H-MRS voxel was either 3.4 or 8 cm 3 . At the time of both spectroscopic examinations, similar voxels' positioning and size and technical parameters of 1 H-MRS were used. Surgery was done in 27 patients within 1 to 68 days thereafter. In all cases, more than 80% resection of the neoplasm was attained. There were 12 low-grade gliomas and 15 high-grade gliomas. MIB-1 index varied from 0% to 51.7% (median, 13.8%). Statistical analysis did not disclose significant differences of any investigated metabolic parameter of the tumor, peritumoral brain tissue and distant normal-appearing white matter between two spectroscopic examinations. Single-voxel 1 H-MRS at 1.5 T could not detect significant changes of the metabolic characteristics of gliomas, peritumoral brain tissue, and distant normal-appearing white matter after oral administration of choline. (orig.)

  18. Hospital length of stay in patients initiated on direct oral anticoagulants versus warfarin for venous thromboembolism: a real-world single-center study.

    Science.gov (United States)

    Badreldin, Hisham

    2018-04-06

    This study was conducted to describe the real-world hospital length of stay in patients treated with all of the U.S. Food and Drug Administration approved direct oral anticoagulants (DOACs) versus warfarin for new-onset venous thromboembolism (VTE) at a large, tertiary, academic medical center. A retrospective cohort analysis of all adult patients diagnosed with acute onset VTE was conducted. Of the 441 patients included, 261 (57%) patients received DOACs versus 180 (41%) patients received warfarin. In the DOAC group, a total of 92 (35%) patients received rivaroxaban, followed by 83 (32%) patients received apixaban, 50 (19%) patients received dabigatran, and 36 (14%) patients received edoxaban. Patients initiated on DOACs had a statistically significant shorter hospital length of stay compared to patients initiated on warfarin (median 3 days, [IQR 0-5] vs. 8 days [IQR 5-11], P < 0.05). Despite the shorter hospital length of stay in patients receiving DOACs, the overall reported differences between the DOACs group and the warfarin group in terms of recurrent VTE, major bleeding, intracranial bleeding, and gastrointestinal bleeding at 3 and 6 months were deemed to be statistically insignificant.

  19. Oral paracetamol and/or ibuprofen for treating pain after soft tissue injuries: Single centre double-blind, randomised controlled clinical trial.

    Science.gov (United States)

    Hung, Kevin K C; Graham, Colin A; Lo, Ronson S L; Leung, Yuk Ki; Leung, Ling Yan; Man, S Y; Woo, W K; Cattermole, Giles N; Rainer, Timothy H

    2018-01-01

    Soft tissue injuries commonly present to the emergency department (ED), often with acute pain. They cause significant suffering and morbidity if not adequately treated. Paracetamol and ibuprofen are commonly used analgesics, but it remains unknown if either one or the combination of both is superior for pain control. To investigate the analgesic effect of paracetamol, ibuprofen and the combination of both in the treatment of soft tissue injury in an ED, and the side effect profile of these drugs. Double-blind, double dummy, placebo-controlled randomised controlled trial. 782 adult patients presenting with soft tissue injury without obvious fractures attending the ED of a university hospital in the New Territories of Hong Kong were recruited. Patients were randomised using a random number table into three parallel arms of paracetamol only, ibuprofen only and a combination of paracetamol and ibuprofen in a 1:1:1 ratio. The primary outcome measure was pain score at rest and on activity in the first 2 hours and first 3 days. Data was analysed on an intention to treat basis. There was no statistically significant difference in pain score in the initial two hours between the three groups, and no clinically significant difference in pain score in the first three days. There was no difference in analgesic effects or side effects observed using oral paracetamol, ibuprofen or a combination of both in patients with mild to moderate pain after soft tissue injuries attending the ED. The study is registered with ClinicalTrials.gov (no. NCT00528658).

  20. Morning exorcism

    Directory of Open Access Journals (Sweden)

    David Ottosson

    2014-05-01

    Full Text Available After a night of neurons firing unchecked around your brain, five to nine a.m. is the time to reassert discipline – to get organized for the day. Ironically, the simplest discipline has unforeseeable consequences – something that can be exploited.

  1. Morning sickness

    Science.gov (United States)

    ... Obstetrics at Johns Hopkins University School of Medicine, Baltimore, MD. Review provided by VeriMed Healthcare Network. Also reviewed by David Zieve, MD, MHA, Medical Director, Brenda Conaway, Editorial ...

  2. Oral health-related quality of life changes after placement of immediately loaded single implants in healed alveolar ridges or extraction sockets: a 5-year prospective follow-up study.

    Science.gov (United States)

    Raes, Stefanie; Raes, Filiep; Cooper, Lyndon; Giner Tarrida, Luis; Vervaeke, Stijn; Cosyn, Jan; De Bruyn, Hugo

    2017-06-01

    The impact of single implants on oral health-related quality of life (OHRQoL) is scarcely investigated, especially when combined with immediate placement and loading in extraction sockets. The aim was to describe prospectively the changes of OHRQoL with single implants placed in the esthetic zone in healed ridges or in extraction sockets after 5 years. Ninety-six patients, enrolled at three clinical centers, received 102 single implants placed in a healed ridge (n = 54 implants/50 patients) or in extraction sockets (n = 48 implants/46 patients). Implants were immediately provisionalized, and permanent crowns were cemented after 12 weeks. Oral health impact profile questionnaires (OHIP-14) were completed before surgery, after 1 (provisional crown), 6 (permanent crown), 12 and 60 months, respectively. The overall OHIP-14 score pertains to seven domains with two items each and was assessed on a Likert scale of 0-4 (0 = never and 4 = very often). The evolution of the total OHIP-14 score and changes within all OHIP domains over time and between groups were assessed with a linear mixed-effect model analysis. After 5 years, overall implant survival was 98%. The total OHIP-14 score for both groups combined decreased from 0.50 at baseline to 0.17 at 6 months (P < 0.001), indicative of improvement. For both groups, this remained stable up to 5 years (P = 0.41). However, after 5 years, the total OHIP-14 score revealed a statistically significantly higher improvement in the healed group compared with the extraction group (P = 0.027). Missing a single tooth in the maxillary esthetic zone leads to limited OHRQoL problems as reflected by a low overall OHIP score. However, OHRQoL improves less in the extraction group, reflecting that replacing a missing tooth is perceived as more beneficial than replacing a present tooth. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  3. Pharmacokinetics and Tolerability of Rufinamide Following Single and Multiple Oral Doses and Effect of Food on Pharmacokinetics in Healthy Chinese Subjects.

    Science.gov (United States)

    Xu, Mingzhen; Ni, Yang; Zhou, Ying; He, Xiaomeng; Li, Huqun; Chen, Hui; Li, Weiyong

    2016-10-01

    Rufinamide is a triazole derivative that is structurally unrelated to currently marketed antiepileptic medications for add-on treatment of seizures in the setting of Lennox-Gastaut syndrome in patients from the age of 4 years. The purpose of this study was to determine the pharmacokinetic and safety profile of single and multiple doses of rufinamide in healthy Chinese subjects. The effects of food and gender on the pharmacokinetic properties of rufinamide were also evaluated. In the single-dose study, volunteers were randomly assigned to 4 dose groups and received a single dose of 200, 400, 800, 1200 mg rufinamide tablets under fasting condition. Ten subjects in the 200-mg dose group were randomly assigned to either a high-fat or non-high-fat breakfast group in each study period. The drug administration was separated by a washout period of 7 calendar days. In the multiple-dose study, 10 subjects were administered on an empty stomach rufinamide 200 mg twice daily for 6 consecutive days. Liquid chromatography tandem mass spectrometry (LC-MS/MS) method was applied to determine plasma concentration of rufinamide. Pharmacokinetic parameters, including the maximum plasma concentration (C max), the time to peak concentration (t max), the area under the plasma concentration versus time curve from time 0 to the last measurable concentration (AUC0-t ) and from time 0 to infinity (AUC0-∞), terminal elimination half-life (t 1/2), apparent volume of distribution (V d), apparent clearance (CL), average residence time (MRT), area under the plasma concentration versus time curve from time 0 to the last measurable concentration at steady state (AUCss), peak concentration (C max,ss) and trough level concentration (C min,ss) at steady state were calculated using non-compartmental models. Tolerability was assessed based on investigator inquiries, spontaneous reports and clinical evaluations. Rufinamide displayed a dose-dependent, but sub-proportional increase in exposure

  4. Development of the chronic obstructive pulmonary disease morning symptom diary (COPD-MSD).

    Science.gov (United States)

    Globe, Gary; Currie, Brooke; Leidy, Nancy Kline; Jones, Paul; Mannino, David; Martinez, Fernando; Klekotka, Paul; O'Quinn, Sean; Karlsson, Niklas; Wiklund, Ingela

    2016-07-16

    The morning tends to be the most difficult time of day for many patients with chronic obstructive pulmonary disease (COPD) when symptoms can limit one's ability to perform even simple activities. Morning symptoms have been linked to higher levels of work absenteeism, thereby increasing the already substantial economic burden associated with COPD. A validated patient-reported outcome (PRO) instrument designed to capture morning symptoms will allow for a more comprehensive approach to the evaluation of treatment benefit in COPD clinical trials. A qualitative interview study was conducted among a sample of symptomatic adults with COPD. Concept elicitation interviews (n = 35) were conducted to identify COPD morning symptoms, followed by cognitive interviews (n = 21) to ensure patient comprehension of the items, instructions and response options of the draft COPD Morning Symptom Diary (COPD-MSD). All interview transcript data were coded using ATLAS.ti software for content analysis. Mean age of the concept elicitation and cognitive interview sample was 65.0 years (±7.5) and 62.3 years (±8.3), respectively. The study sample represented the full range of COPD severity (Global Initiative for Chronic Lung Disease [GOLD] classifications I-IV) and included a mix of racial backgrounds, employment status and educational achievement. During the concept elicitation interviews, the three most frequently reported morning symptoms were shortness of breath (n = 35/35; 100 %), phlegm/mucus (n = 31/35; 88.6 %), and cough (n = 30/35; 85.7 %). A group of clinical and instrument development experts convened to review the concept elicitation data and develop the initial 32-item draft COPD-MSD. Cognitive interviews indicated subjects found the draft COPD-MSD to be comprehensive, clear, and easy to understand. The COPD-MSD underwent minor editorial revisions and streamlining based on cognitive interviews and input from the experts to yield the final 19-item daily

  5. Comparison of the Effect of Pre-operative Single Oral Dose of Tramadol and Famotidine on Gastric Secretions pH and Volume in Patients Scheduled for Laparoscopic Cholecystectomy

    International Nuclear Information System (INIS)

    Khan, M. U.; Aqil, M.; Hussain, A.; Zahrani, T. A.; Hillis, M.

    2015-01-01

    Objective: To evaluate and compare the effects of pre-operative single oral dose of tramadol and famotidine on gastric secretions pH and volume in patients electively scheduled for laparoscopic cholecystectomy. Study Design: Randomized control trial. Place and Duration of Study: Department of Anaesthesia, King Saud University Riyadh, Saudi Arabia, from August 2011 to June 2013. Methodology: Ninety adult, ASA-I and II patients scheduled for laparoscopic cholecystectomy were included in the study. Patients were randomly assigned to receive pre-operatively either placebo (Group-C, n=30), oral tramadol 100 mg (Group-T, n=30) or famotidine 40 mg (Group-F, n=30). After induction of general anaesthesia, gastric fluid was aspirated through orogastric tube. The gastric secretions volume and pH was measured using pH meter. Results:There was no statistically difference between groups in age, weight and gender. The gastric secretions mean pH was 2.06 ± 0.22,2.04 ± 0.20, 5.79 ± 0.77 and volume was 0.59 ± 0.17, 0.59 ± 0.14 and 0.28 ± 0.16 ml/kg in Group-C, Group-T and Group-F respectively. There was a significant statistical difference in the mean pH values between Group-C vs. Group-F (p greater than 0.001) and Group-Tvs. Group-F (p greater than 0.001). Statistically significant difference was also found in the mean gastric secretions volume between Group - C vs. Group-F (p greater than 0.001) and Group-Tvs. Group-F (p greater than 0.001). There was no significant difference in the mean gastric fluid pH values (p=0.99) and mean gastric secretions volume (p=0.99) between Group-Tand Group-C. Conclusion:As compared to famotidine, pre-operative single oral dose of tramadol was unable to elevate the desired level of gastric fluid pH (less than 2.5) and decrease in gastric secretions volume (greater than 0.4ml/kg). (author)

  6. Oral Hygiene

    DEFF Research Database (Denmark)

    Sørensen, Marie Toftdahl; Villadsen, Dorte Buxbom

    The aim of the study was to explore how adults with schizo- phrenia describe their lived experiences with oral hygiene. 23 adults with schizophrenia were interviewed within a period of four months in late 2015. Transcriptions of the interviews were analysed using the Reflective Lifeworld Research...... phenomenological approach of Dahlberg, Dahlberg, and Nyström. The essence of the phenomenon, oral hygiene, is described as a challenge: a mixture of ability and assigning priority; a challenge in which significant others, for better or worse, play an important role. We recommend a systematic cooperation between...... health care professionals and adults with schizophrenia in order to improve oral health, well-being and recovery....

  7. Oral Hygiene

    DEFF Research Database (Denmark)

    Villadsen, Dorte Buxbom; Sørensen, Marie Toftdahl

    2017-01-01

    The aim of the study is to explore how adults with schizophrenia describe their lived experiences with oral hygiene. 23 adults with schizophrenia were interviewed within a period of four months in late 2015. Transcriptions of the interviews were analysed using the Reflective Lifeworld Research...... phenomenological approach of Dahlberg, Dahlberg, and Nyström. The essence of the phenomenon, oral hygiene, is described as a challenge: a mixture of ability and assigning priority; a challenge in which significant others, for better or worse, play an important role. We recommend a systematic cooperation between...... health care professionals and adults with schizophrenia in order to improve oral health, well-being and recovery....

  8. Oral Histoplasmosis.

    Science.gov (United States)

    Folk, Gillian A; Nelson, Brenda L

    2017-12-01

    A 44-year-old female presented to her general dentist with the chief complaint of a painful mouth sore of 2 weeks duration. Clinical examination revealed an irregularly shaped ulcer of the buccal and lingual attached gingiva of the anterior mandible. A biopsy was performed and microscopic evaluation revealed histoplasmosis. Histoplasmosis, caused by Histoplasma capsulate, is the most common fungal infection in the United States. Oral lesions of histoplasmosis are generally associated with the disseminated form of histoplasmosis and may present as a fungating or ulcerative lesion of the oral mucosa. The histologic findings and differential diagnosis for oral histoplasmosis are discussed.

  9. The effect of food composition on serum testosterone levels after oral administration of Andriol Testocaps.

    Science.gov (United States)

    Schnabel, Peter G; Bagchus, Wilma; Lass, Holger; Thomsen, Torben; Geurts, T B Paul

    2007-04-01

    Andriol Testocaps is a new oral formulation of testosterone undecanoate (TU) for treatment of hypogonadism. As TU is taken up by the intestinal lymphatic system, both the presence and the composition of food influence the absorption. The aim of this study was to investigate the effect of food composition on the pharmacokinetics of oral TU. An open-label, single-centre, four-way crossover study. With a washout period of 6-7 days, 80 mg TU was administered in the morning 5 min after consuming each of four different meals in a randomized order (A: 230 kcal, 0.6 g lipid; B: 220 kcal, 5 g lipid; C: 474 kcal, 19 g lipid; D: 837 kcal, 44 g lipid). Twenty-four postmenopausal volunteers. Serial blood samples were collected until 24 h after dosing to determine testosterone and dihydrotestosterone (DHT) by gas chromatography-mass spectroscopy (GC-MS). The bioavailability of testosterone after a low-calorie meal containing 0.6 g lipid or 5 g lipid was relatively low, the area under the concentration-time curve (AUC(0-tlast)) for testosterone being 30.7 and 43.5 nmol h/l, respectively. The bioavailability of testosterone after a meal containing 19 g lipid was considerably higher (AUC(0-tlast) = 146 nmol h/l), whereas increasing the lipid content to 44 g lipid did not further increase the bioavailability of testosterone (AUC(0-tlast) = 154 nmol h/l). Approximately 19 g of lipid per meal efficiently increases absorption of testosterone from oral TU. Therefore, coadministration with a normal rather than a fatty meal is sufficient to increase serum testosterone levels when using oral TU.

  10. Pharmacokinetics and oral bioavailability of metformin hydrochloride in healthy mixed-breed dogs.

    Science.gov (United States)

    Johnston, Charlotte A; Dickinson, Valerie S MacDonald; Alcorn, Jane; Gaunt, M Casey

    2017-10-01

    OBJECTIVE To investigate the pharmacokinetics of metformin hydrochloride in healthy dogs after IV and oral bolus administrations and determine the oral dose of metformin that yields serum concentrations equivalent to those thought to be effective in humans. ANIMALS 7 healthy adult mixed-breed dogs. PROCEDURES Each dog was given a single dose of metformin IV (mean ± SD dose, 24.77 ± 0.60 mg/kg) or PO (mean dose, 19.14 ± 2.78 mg/kg) with a 1-week washout period between treatments. For each treatment, blood samples were collected before and at intervals up to 72 hours after metformin administration. Seventy-two hours after the crossover study, each dog was administered metformin (mean dose, 13.57 ± 0.55 mg/kg), PO, twice daily for 7 days. Blood samples were taken before treatment initiation on day 0 and immediately before the morning drug administration on days 2, 4, 6, and 7. Serum metformin concentrations were determined by means of a validated flow injection analysis-tandem mass spectrometry method. RESULTS After IV or oral administration to the 7 dogs, there was high interindividual variability in mean serum metformin concentrations over time. Mean ± SD half-life of metformin following IV administration was 20.4 ± 4.1 hours. The mean time to maximum serum concentration was 2.5 ± 0.4 hours. Mean systemic clearance and volume of distribution were 24.1 ± 7.8 mL/min/kg and 44.8 ± 23.5 L/kg, respectively. The mean oral bioavailability was 31%. CONCLUSIONS AND CLINICAL RELEVANCE The study data indicated that the general disposition pattern and bioavailability of metformin in dogs are similar to those reported for cats and humans.

  11. Bivalent oral cholera vaccine in participants aged 1 year and older in the Dominican Republic: A phase III, single-arm, safety and immunogenicity trial.

    Science.gov (United States)

    Cordero De Los Santos, Lina; Feris-Iglesias, Jesús; Aloysia D'Cor, Naveena; Midde, Venkata Jayanth; Patnaik, Badri Narayan; Thollot, Yaël; Rasuli, Anvar; Desauziers, Eric

    2018-02-22

    The Dominican Republic, historically non-endemic for cholera, is experiencing an ongoing cholera epidemic. We assessed the safety and immunogenicity of two doses of the killed bivalent (O1 and O139) whole-cell oral cholera vaccine (OCV) on day (D)0 and D14 in healthy participants aged ≥1 year. Immediate unsolicited systemic adverse events (AEs) were monitored up to 30 minutes and solicited systemic reactions, up to 7 days after each vaccination. Unsolicited AEs were recorded up to D14 (post-dose 1) and 30 days post-dose 2. A vibriocidal antibody assay with microtiter technique was used to measure serum antibodies to V. cholerae strains (O1 El Tor Inaba, O1 El Tor Ogawa, O139) on D0, D14 and D28. Geometric mean titers (GMTs) and seroconversion (≥4-fold increase from D0) rates were calculated. We recruited 336 participants; 112 in three age groups (1-4, 5-14 and ≥15 years). No safety concerns were observed. GMTs increased from baseline for all serotypes, with marked increases for O1 Inaba and Ogawa post-dose 1. Post-dose 2 GMTs tended to be equal or slightly lower, with ranges: O1 Inaba, 283 (95% confidence interval 191-419) to 612 (426-880); O1 Ogawa, 346 (223-536) to 754 (553-1028); and O139, 20.3 (13.5-30.6) to 43.8 (30.1-63.7). Seroconversion rates post-dose 2 for O1 Inaba and Ogawa were high (≥87%) for all age groups. OCV demonstrated an acceptable safety profile and robust immunogenicity in these participants, in-line with previous observations in epidemic and endemic settings.This study is registered on www.clinicaltrials.gov (NCT02434822).

  12. Efficacy of different brands of mouth rinses on oral bacterial load ...

    African Journals Online (AJOL)

    Subjects were divided into 3 groups and their saliva samples were assessed for microbial counts at the beginning and the end of an eight-week period during which they rinsed with 10ml of mouthrinse for 15 seconds twice daily (morning and evening) in addition to their usual oral hygiene procedures.The results showed ...

  13. Morning glory disc anomaly, midline cranial defects and abnormal carotid circulation: an association worth looking for

    Energy Technology Data Exchange (ETDEWEB)

    Quah, Boon Long [Kandang Kerbau Women' s and Children' s Hospital, Singapore National Eye Centre, Department of Ophthalmology (Singapore); Hamilton, Jill [Hospital for Sick Children, Department of Paediatrics, Toronto, ON (Canada); Blaser, Susan [Hospital for Sick Children, Department of Diagnostic Imaging, Toronto, ON (Canada); Heon, Elise; Tehrani, Nasrin N. [Hospital for Sick Children, Department of Ophthalmology and Vision Sciences, Toronto, ON (Canada)

    2005-05-01

    We report on a 4-year-old boy who presented to the ophthalmology department for assessment of convergent strabismus. Ophthalmic examination showed a left morning glory optic disc anomaly and retinal detachment. Plain films obtained for investigation of short stature prior to ophthalmic examination revealed delayed bone age. Ophthalmological findings prompted CT and MRI imaging and angiographic investigations. Midline cranial defects and abnormal carotid circulation were identified. These findings may be associated with morning glory optic disc anomaly, and their association is often under-recognized. It is important that clinicians and radiologists be aware of this spectrum of disorders, as the vascular abnormalities may predispose the patient to transient ischemic attacks and strokes. Growth delay may result from hypopituitarism. (orig.)

  14. Morning glory disc anomaly, midline cranial defects and abnormal carotid circulation: an association worth looking for

    International Nuclear Information System (INIS)

    Quah, Boon Long; Hamilton, Jill; Blaser, Susan; Heon, Elise; Tehrani, Nasrin N.

    2005-01-01

    We report on a 4-year-old boy who presented to the ophthalmology department for assessment of convergent strabismus. Ophthalmic examination showed a left morning glory optic disc anomaly and retinal detachment. Plain films obtained for investigation of short stature prior to ophthalmic examination revealed delayed bone age. Ophthalmological findings prompted CT and MRI imaging and angiographic investigations. Midline cranial defects and abnormal carotid circulation were identified. These findings may be associated with morning glory optic disc anomaly, and their association is often under-recognized. It is important that clinicians and radiologists be aware of this spectrum of disorders, as the vascular abnormalities may predispose the patient to transient ischemic attacks and strokes. Growth delay may result from hypopituitarism. (orig.)

  15. Morphological, molecular and hormonal adaptations to early morning versus afternoon resistance training.

    Science.gov (United States)

    Sedliak, Milan; Zeman, Michal; Buzgó, Gabriel; Cvecka, Jan; Hamar, Dusan; Laczo, Eugen; Okuliarova, Monika; Vanderka, Marian; Kampmiller, Tomas; Häkkinen, Keijo; Ahtiainen, Juha P; Hulmi, Juha J; Nilsen, Tormod S; Wiig, Håvard; Raastad, Truls

    2017-12-28

    It has been clearly established that maximal force and power is lower in the morning compared to noon or afternoon hours. This morning neuromuscular deficit can be diminished by regularly training in the morning hours. However, there is limited and contradictory information upon hypertrophic adaptations to time-of-day-specific resistance training. Moreover, no cellular or molecular mechanisms related to muscle hypertrophy adaptation have been studied with this respect. Therefore, the present study examined effects of the time-of-day-specific resistance training on muscle hypertrophy, phosphorylation of selected proteins, hormonal concentrations and neuromuscular performance. Twenty five previously untrained males were randomly divided into a morning group (n = 11, age 23 ± 2 yrs), afternoon group (n = 7, 24 ± 4 yrs) and control group (n = 7, 24 ± 3 yrs). Both the morning and afternoon group underwent hypertrophy-type of resistance training with 22 training sessions over an 11-week period performed between 07:30-08:30 h and 16:00-17:00 h, respectively. Isometric MVC was tested before and immediately after an acute loading exclusively during their training times before and after the training period. Before acute loadings, resting blood samples were drawn and analysed for plasma testosterone and cortisol. At each testing occasion, muscle biopsies from m. vastus lateralis were obtained before and 60 min after the acute loading. Muscle specimens were analysed for muscle fibre cross-sectional areas (CSA) and for phosphorylated p70S6K, rpS6, p38MAPK, Erk1/2, and eEF2. In addition, the right quadriceps femoris was scanned with MRI before and after the training period. The control group underwent the same testing, except for MRI, between 11:00 h and 13:00 h but did not train. Voluntary muscle strength increased significantly in both the morning and afternoon training group by 16.9% and 15.2 %, respectively. Also muscle hypertrophy occurred by 8.8% and

  16. Morning plasma cortisol is low among obese women with polycystic ovary syndrome.

    Science.gov (United States)

    Shabir, Iram; Ganie, Mohd Ashraf; Praveen, Edavan P; Khurana, Madan L; John, Jomimol; Gupta, Nandita; Kumar, Guresh; Ammini, Ariachery C

    2013-12-01

    Polycystic ovary syndrome (PCOS) is the most common cause for androgen excess in women. It is associated with wide variety of metabolic disorders. The present study assessed morning plasma cortisol in women with PCOS. One hundred and ninety seven cases and 55 controls were enrolled for this study. The mean age of patients and controls were 23 ± 5.6 years and 25 ± 4.3 years. One hundred twelve (56%) women with PCOS had BMI >25. Serum cortisol levels were significantly higher in lean PCOS women compared to controls (13.4 ± 5.1 versus 11.3 ± 4.5, p cortisol was lower among obese women with PCOS. Morning plasma cortisol correlated negatively with BMI in PCOS women with normal glucose tolerance.

  17. Detection of Early Morning Daily Activities with Static Home and Wearable Wireless Sensors

    Directory of Open Access Journals (Sweden)

    David Vanderpool

    2007-10-01

    Full Text Available This paper describes a flexible, cost-effective, wireless in-home activity monitoring system for assisting patients with cognitive impairments due to traumatic brain injury (TBI. The system locates the subject with fixed home sensors and classifies early morning bathroom activities of daily living with a wearable wireless accelerometer. The system extracts time- and frequency-domain features from the accelerometer data and classifies these features with a hybrid classifier that combines Gaussian mixture models and a finite state machine. In particular, the paper establishes that despite similarities between early morning bathroom activities of daily living, it is possible to detect and classify these activities with high accuracy. It also discusses system training and provides data to show that with proper feature selection, accurate detection and classification are possible for any subject with no subject specific training.

  18. Creating Modern Japanese Subjects: Morning Rituals from Norito to News and Weather

    Directory of Open Access Journals (Sweden)

    Wilburn Hansen

    2016-03-01

    Full Text Available This original research on Restoration Shinto Norito seeks to explain the rhetorical devices used in the composition of a morning prayer ritual text. The nativist scholar, Hirata Atsutane, crafted this ritual to create a Japanese imperial subject with a particular understanding of native identity and national unity, appropriate to the context of a Japan in the shadow of impending modernity and fear of Western domination. The conclusions drawn concerning Hirata’s rhetoric are meant to inform our understanding of the technique and power of the contemporary Japanese morning television viewing ritual used to create post-modern Japanese citizens with an identity and unity appropriate to a global secular context.

  19. Herpes - oral

    Science.gov (United States)

    ... virus type 2 (HSV-2) most often causes genital herpes . However, sometimes HSV-2 is spread to the ... the virus to the genitals. Both oral and genital herpes viruses can sometimes be spread, even when you ...

  20. Transcriptome Profiling of Beach Morning Glory (Ipomoea imperati) under Salinity and Its Comparative Analysis with Sweetpotato

    Science.gov (United States)

    Solis, Julio; Baisakh, Niranjan; Brandt, Steven R.; Villordon, Arthur; La Bonte, Don

    2016-01-01

    The response and adaption to salt remains poorly understood for beach morning glory [Ipomoea imperati (Vahl) Griseb], one of a few relatives of sweetpotato, known to thrive under salty and extreme drought conditions. In order to understand the genetic mechanisms underlying salt tolerance of a Convolvulaceae member, a genome-wide transcriptome study was carried out in beach morning glory by 454 pyrosequencing. A total of 286,584 filtered reads from both salt stressed and unstressed (control) root and shoot tissues were assembled into 95,790 unigenes with an average length of 667 base pairs (bp) and N50 of 706 bp. Putative differentially expressed genes (DEGs) were identified as transcripts overrepresented under salt stressed tissues compared to the control, and were placed into metabolic pathways. Most of these DEGs were involved in stress response, membrane transport, signal transduction, transcription activity and other cellular and molecular processes. We further analyzed the gene expression of 14 candidate genes of interest for salt tolerance through quantitative reverse transcription PCR (qRT-PCR) and confirmed their differential expression under salt stress in both beach morning glory and sweetpotato. The results comparing transcripts of I. imperati against the transcriptome of other Ipomoea species, including sweetpotato are also presented in this study. In addition, 6,233 SSR markers were identified, and an in silico analysis predicted that 434 primer pairs out of 4,897 target an identifiable homologous sequence in other Ipomoea transcriptomes, including sweetpotato. The data generated in this study will help in understanding the basics of salt tolerance of beach morning glory and the SSR resources generated will be useful for comparative genomics studies and further enhance the path to the marker-assisted breeding of sweetpotato for salt tolerance. PMID:26848754

  1. Resin glycoside constituents of Ipomoea pes-caprae (beach morning glory).

    Science.gov (United States)

    Tao, Hongwen; Hao, Xiaojiang; Liu, Jinggen; Ding, Jian; Fang, Yuchun; Gu, Qianqun; Zhu, Weiming

    2008-12-01

    Eight new resin glycosides, pescapreins X-XVII (1-8), were isolated from a lipophilic fraction of an ethanol extract of the entire plant of beach morning glory, Ipomoea pes-caprae. Their structures were elucidated by spectroscopic data analysis and by chemical transformation. These compounds were evaluated biologically in terms of cancer cell line cytotoxicity, antibacterial and antifungal activity, and effects on the mu-opioid receptor.

  2. Transcriptome Profiling of Beach Morning Glory (Ipomoea imperati under Salinity and Its Comparative Analysis with Sweetpotato.

    Directory of Open Access Journals (Sweden)

    Julio Solis

    Full Text Available The response and adaption to salt remains poorly understood for beach morning glory [Ipomoea imperati (Vahl Griseb], one of a few relatives of sweetpotato, known to thrive under salty and extreme drought conditions. In order to understand the genetic mechanisms underlying salt tolerance of a Convolvulaceae member, a genome-wide transcriptome study was carried out in beach morning glory by 454 pyrosequencing. A total of 286,584 filtered reads from both salt stressed and unstressed (control root and shoot tissues were assembled into 95,790 unigenes with an average length of 667 base pairs (bp and N50 of 706 bp. Putative differentially expressed genes (DEGs were identified as transcripts overrepresented under salt stressed tissues compared to the control, and were placed into metabolic pathways. Most of these DEGs were involved in stress response, membrane transport, signal transduction, transcription activity and other cellular and molecular processes. We further analyzed the gene expression of 14 candidate genes of interest for salt tolerance through quantitative reverse transcription PCR (qRT-PCR and confirmed their differential expression under salt stress in both beach morning glory and sweetpotato. The results comparing transcripts of I. imperati against the transcriptome of other Ipomoea species, including sweetpotato are also presented in this study. In addition, 6,233 SSR markers were identified, and an in silico analysis predicted that 434 primer pairs out of 4,897 target an identifiable homologous sequence in other Ipomoea transcriptomes, including sweetpotato. The data generated in this study will help in understanding the basics of salt tolerance of beach morning glory and the SSR resources generated will be useful for comparative genomics studies and further enhance the path to the marker-assisted breeding of sweetpotato for salt tolerance.

  3. Reactions of Persons with Dementia to Caregivers Singing in Morning Care Situations

    OpenAIRE

    Hammar, Lena Marmstål; Emami, Azita; Engström, Gabriella; Götell, Eva

    2010-01-01

    Music therapeutic caregiving', when caregivers sing for or together with persons with severe dementia during care situations, has been suggested as a way to reduce problematic behaviors in dementia care. The present study implemented this technique as an intervention in dementia care. Six caregivers participated in group interviews about their experiences of morning care situations without and with'Music therapeutic caregiving'. Through a qualitative content analysis two themes emerged.'Being...

  4. Prevalence and risk factors of morning headaches in the general population.

    Science.gov (United States)

    Ohayon, Maurice M

    2004-01-12

    To determine the prevalence of chronic morning headaches (CMH) in the general population and their relationship to sociodemographic characteristics, psychoactive substance use, and organic, sleep, and mental disorders. A telephone questionnaire was submitted to 18 980 individuals 15 years or older and representative of the general populations of the United Kingdom, Germany, Italy, Portugal, and Spain. It included a series of questions about morning headaches, organic disorders, use of psychoactive substances, and sleep and mental disorders in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). Overall, the prevalence of CMH was 7.6% (n = 1442); CMH were reported to occur "daily" by 1.3% of the sample, "often" by 4.4%, and "sometimes" by 1.9%. Rates were higher in women than in men (8.4% vs 6.7%) and in subjects aged between 45 and 64 years (about 9%). The median duration for CMH was 42 months. Various conditions and disorders were found positively associated with CMH. The most significant associated factors were comorbid anxiety and depressive disorders (28.5% vs 5.5%), major depressive disorder alone (21.3% vs 5.5%), dyssomnia not otherwise specified (17.1% vs 6.9%), insomnia disorder (14.4% vs 6.9%), and circadian rhythm disorder (20.0% vs 7.5%). Sleep-related breathing disorder (15.2% vs 7.5%), hypertension (11.0% vs 7.2%), musculoskeletal diseases (14.1% vs 7.1%), use of anxiolytic medication (20.1% vs 7.3%), and heavy alcohol consumption (12.6% vs 7.7%) were also significantly associated with CMH. Morning headache affects 1 individual in 13 in the general population. Chronic morning headaches are a good indicator of major depressive disorders and insomnia disorders. Contrary to what was previously suggested, however, they are not specific to sleep-related breathing disorder.

  5. [Oral contraceptives].

    Science.gov (United States)

    Rozenbaum, H

    1976-10-23

    The author presents an alphabetical list of oral contraceptives. To classify the commercial names of oral contraceptives all over the world is practically impossible for the following reasons: some agents are discontinued without the medical profession being aware of it; the same product can have various names depending on the country and the laboratory. Some products exist in different forms (21 pills including 7 inactive tablets). Finally, some laboratories change the posology of a product without changing its name.

  6. Disparities in Oral Health

    Science.gov (United States)

    ... 2020: Oral Health Objectives Site Map Disparities in Oral Health Recommend on Facebook Tweet Share Compartir Oral health ... to get and keep dental insurance. Disparities in Oral Health Some of the oral health disparities that exist ...

  7. 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

  8. READY TO LEARN: THE IMPACT OF THE MORNING BLAST PHYSICAL ACTIVITY INTERVENTION ON ELEMENTARY SCHOOL STUDENTS

    Directory of Open Access Journals (Sweden)

    Tingting Xu

    2017-08-01

    Full Text Available Objective: The purpose of this study was to investigate the effects of a physical activity intervention programme, named “Morning Blast”, on elementary school students’ math learning and daily physical activity. The Morning Blast intervention programme was a 16-week cardiovascular endurance emphasized physical activity program that students voluntarily participated in before the school day. Participants that volunteered, did so for the duration of the program. Methods: This mixed-methods study included seven educators and 83 students (n=90. The students were all children who were enrolled in Grades 3, 4, and 5 in a semi-rural elementary school in the United States. Data were collected through focus-group interviews, surveys, quantitative analysis of step counts, and from quasi-experimental research design. Results: Students in the experimental group were found to have: (1 increased scores on math standard score, (2 greater confidence in their academic ability, and (3 had more accumulated steps compared to students in the control group. Students in the experimental group also reported that they were more “ready to learn” after completing the physical activity intervention. This finding was also confirmed by their teachers. Conclusion: This study demonstrates how an increase in physical activity during the morning time has positive benefits for students throughout the school day.

  9. Morning self-efficacy predicts physical activity throughout the day in knee osteoarthritis.

    Science.gov (United States)

    Zhaoyang, Ruixue; Martire, Lynn M; Sliwinski, Martin J

    2017-06-01

    The purpose of this study was to examine the within-day and cross-day prospective effects of knee osteoarthritis (OA) patients' self-efficacy to engage in physical activity despite the pain on their subsequent physical activity assessed objectively in their natural environment. Over 22 days, 135 older adults with knee OA reported their morning self-efficacy for being physically active throughout the day using a handheld computer and wore an accelerometer to measure moderate activity and steps. Morning self-efficacy had a significant positive effect on steps and moderate-intensity activity throughout that day, above and beyond the effects of demographic background and other psychosocial factors as well as spouses' support and social control. The lagged effect of morning self-efficacy on the next day's physical activity and the reciprocal lagged effect of physical activity on the next day's self-efficacy were not significant. Positive between-person effects of self-efficacy on physical activity were found. Future research should aim to better understand the mechanisms underlying fluctuations in patients' daily self-efficacy, and target patients' daily self-efficacy as a modifiable psychological mechanism for promoting physical activity. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  10. The impact of morning light intensity and environmental temperature on body temperatures and alertness.

    Science.gov (United States)

    Te Kulve, Marije; Schlangen, Luc J M; Schellen, Lisje; Frijns, Arjan J H; van Marken Lichtenbelt, Wouter D

    2017-06-01

    Indoor temperature and light exposure are known to affect body temperature, productivity and alertness of building occupants. However, not much is known about the interaction between light and temperature exposure and the relationship between morning light induced alertness and its effect on body temperature. Light intensity and room temperature during morning office hours were investigated under strictly controlled conditions. In a randomized crossover study, two white light conditions (4000K, either bright 1200lx or dim 5lx) under three different room temperatures (26, 29 and 32°C) were investigated. A lower room temperature increased the core body temperature (CBT) and lowered skin temperature and the distal-proximal temperature gradient (DPG). Moreover, a lower room temperature reduced the subjective sleepiness and reaction time on an auditory psychomotor vigilance task (PVT), irrespective of the light condition. Interestingly, the morning bright light exposure did affect thermophysiological parameters, i.e. it decreased plasma cortisol, CBT and proximal skin temperature and increased the DPG, irrespective of the room temperature. During the bright light session, subjective sleepiness decreased irrespective of the room temperature. However, the change in sleepiness due to the light exposure was not related to these physiological changes. Copyright © 2017 Elsevier Inc. All rights reserved.

  11. Post hoc analysis of a single IV infusion of zoledronic acid versus daily oral risedronate on lumbar spine bone mineral density in different subgroups with glucocorticoid-induced osteoporosis.

    Science.gov (United States)

    Roux, C; Reid, D M; Devogelaer, J-P; Saag, K; Lau, C S; Reginster, J-Y; Papanastasiou, P; Bucci-Rechtweg, C; Su, G; Sambrook, P N

    2012-03-01

    This study summarizes the treatment effect of zoledronic acid infusion on lumbar spine bone mineral density in different subgroups with glucocorticoid-induced osteoporosis. Zoledronic acid is significantly more effective than risedronate in increasing lumbar spine (LS) bone mineral density (BMD) in both prevention and treatment of glucocorticoid-induced osteoporosis. Introduction In patients on glucocorticoids, a single zoledronic acid infusion significantly increased BMD versus daily oral risedronate. We assessed treatment effect on LS BMD in different patient subgroups at month 12 that contributed to the risk of osteoporosis in addition to glucocorticoids. Methods Patients randomized to a single IV infusion of zoledronic acid 5 mg or risedronate (5 mg/day) and stratified based on glucocorticoids duration [treatment (>3 months) and prevention (≤ 3 months) subpopulations]were subgrouped by age; gender; menopausal status in women; dose and duration of prednisone during the trial; and baseline serum 25-OH vitamin D, LS BMD T-score, creatinine clearance, and concomitant medication use. Results At month 12, zoledronic acid significantly increased LS BMD versus risedronate in patients ≤ 74 years (Pinduced osteoporosis across a wide range of patients.

  12. Effects of Acute Endurance Exercise Performed in the Morning and Evening on Inflammatory Cytokine and Metabolic Hormone Responses.

    Science.gov (United States)

    Kim, Hyeon-Ki; Konishi, Masayuki; Takahashi, Masaki; Tabata, Hiroki; Endo, Naoya; Numao, Shigeharu; Lee, Sun-Kyoung; Kim, Young-Hak; Suzuki, Katsuhiko; Sakamoto, Shizuo

    2015-01-01

    To compare the effects of endurance exercise performed in the morning and evening on inflammatory cytokine responses in young men. Fourteen healthy male participants aged 24.3 ± 0.8 years (mean ± standard error) performed endurance exercise in the morning (0900-1000 h) on one day and then in the evening (1700-1800 h) on another day with an interval of at least 1 week between each trial. In both the morning and evening trials, the participants walked for 60 minutes at approximately 60% of the maximal oxygen uptake (VO2max) on a treadmill. Blood samples were collected to determine hormones and inflammatory cytokines at pre-exercise, immediately post exercise, and 2 h post exercise. Plasma interleukin (IL)-6 and adrenaline concentrations were significantly higher immediately after exercise in the evening trial than in the morning trial (P morning trial at 2 h after exercise (P morning. In addition, IL-6 was involved in increasing free fatty acids, suggesting that the evening is more effective for exercise-induced lipolysis compared with the morning.

  13. Morning-evening difference of team-handball-related short-term maximal physical performances in female team handball players.

    Science.gov (United States)

    Mhenni, Thouraya; Michalsik, Lars Bojsen; Mejri, Mohamed Arbi; Yousfi, Narimen; Chaouachi, Anis; Souissi, Nizar; Chamari, Karim

    2017-05-01

    This study investigated the two different time-of-day effect on team-handball-related short-term maximal physical performances. At two different time-of-day, fifteen young female team handball players performed different physical tests: HandGrip (HG) test, Ball-Throwing Velocity (BTV) test, Modified Agility T-test (MAT) and Repeated Shuttle-Sprint and Jump Ability (RSSJA) test. Rating of perceived exertion (RPE) scale was determined following the termination of the last test. Measurements were performed at two separate testing sessions (i.e., in the morning (7:00-8:30 h) and in the early evening (17:00-18:30 h)) in a randomised and counter-balanced setting on non-consecutive days. The results showed that HG (P = 0.0013), BTV (P = 0.0027) and MAT (P morning. During RSSJA, both best and mean sprint times were shorter in the evening compared to the morning (P morning (P = 0.026). However, there was no morning-evening difference in the best jump performance during RSSJA. Likewise, jump performance decrement was not affected by the time-of-day of testing. On the other hand, RPE fluctuated, with morning nadirs and afternoon/early evening highest values. The findings suggest that in female team handball players, team-handball-related short-term maximal physical performances were better in the afternoon than in the morning.

  14. Bioequivalence of a single 400-mg dose of imatinib 100-mg oral tablets and a 400-mg tablet in healthy adult Korean volunteers.

    Science.gov (United States)

    Lee, Hae Won; Seong, Sook Jin; Park, Sung Min; Lee, Joomi; Gwon, Mi-Ri; Kim, Hyun-Ju; Lim, Sung Mook; Lim, Mi-Sun; Kim, Woomi; Yang, Dong Heon; Yoon, Young-Ran

    2015-06-01

    Imatinib mesylate (IM) is a selective tyrosine kinase inhibitor for the treatment of chronic myeloid leukemia and gastrointestinal stromal tumors. A new once-daily 400-mg film-coated tablet of imatinib has been developed by a pharmaceutical company in Korea. The present study was designed to assess and compare the PK parameters, bioavailability, and bioequivalence of the new imatinib 400-mg formulation (test) versus the conventional 100-mg formulation (reference) administered as a single 400-mg dose in healthy adult male volunteers. This randomized, open-label, single-dose, two-way crossover study was conducted in healthy Korean male volunteers. Eligible subjects were randomly assigned in a 1 : 1 ratio to receive 400 mg of the test (one 400-mg tablet) or reference (four 100-mg tablets) formulation, followed by a 2-week washout period and administration of the alternate formulation. Serial blood samples were collected at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours after administration. Plasma imatinib concentrations were determined using liquid chromatography coupled with tandem mass spectrometry. The formulations were to be considered bioequivalent if the 90% confidence intervals (CIs) of the adjusted geometric mean ratios for Cmax, AUC(0-t), and AUC(0-∞)ž were within the predetermined range of 0.80 - 1.25. In total, 35 subjects completed the study. No serious adverse event was reported during the study. The 90% CIs of the adjusted geometric mean ratios of the test formulation to the reference formulation for C(max), AUC(0-t) and AUC(0-∞)ž of imatinib were all within the bioequivalence criteria range of 0.8 - 1.25. The test formulation of imatinib met the Korean regulatory requirements for bioequivalence. Both imatinib formulations were well-tolerated in all subjects.

  15. Correlation between the morning hypertension on ambulatory blood pressure monitoring and the left ventricular mass in children.

    Science.gov (United States)

    Kim, Hyun Jung; Kim, Kyung Hee; Kil, Hong Ryang

    2014-09-01

    Although high morning blood pressure (BP) is known to be associated with the onset of cardiovascular events in adults, data on its effects in children with hypertension are limited. Our retrospective study aimed to define the clinical characteristics of children with morning hypertension (MH) and to determine its associated factors. We reviewed 31 consecutive patients with hypertension, confirmed by the ambulatory blood pressure monitoring (ABPM). We divided these patients into 2 groups: the MH group (n=21, 67.7%), morning BP above the 95th percentile for age and height (2 hours on average after waking up) and the normal morning BP group (n=10, 32.3%). We compared the clinical manifestations, laboratory results, and echocardiographic findings including left ventricular hypertrophy (LVH) between the groups. The early/atrial (E/A) mitral flow velocity ratio in the MH group was significantly lower than that in the normal morning BP group. In addition, LV mass was higher in the MH group than in the normal morning BP group, although the difference was not statistically significant. The age at the time of hypertension diagnosis was significantly higher in the MH group than in the normal morning BP group (P=0.003). The incidence of hyperuricemia was significantly higher in the MH group than in the normal morning BP group. Older patients and those with hyperuricemia are at higher risk for MH. The rise in BP in the morning is an important factor influencing the development of abnormal relaxation, as assessed by echocardiography. Clinical trials with longer follow-up periods and larger sample sizes are needed to clarify the clinical significance of MH.

  16. Is the Morning Sputum Sample Superior to the Fresh Sputum Sample for the Detection of Malignant Cells?

    Science.gov (United States)

    Uke, Maya S; Pathuthara, Saleem; Shaikh, Abida; Kumar, Rajiv; Kane, Shubhada

    2017-01-01

    Sputum cytology is a well-established technique for the detection of lung malignancies. Generally, random or morning samples are used. To evaluate the diagnostic yield of morning sputum and compare it with that of fresh samples. Patients were instructed to bring a morning sputum sample to the laboratory in a clean plastic container, without any fixative and within 2-3 h of collection. Fresh sputum was then collected in the laboratory from these same patients. Two smears were prepared from each sample by the "pick and smear" technique and then stained by the Papanicolaou method. One hundred samples from each method (total 200 samples; 400 slides) were evaluated by 3 investigators for their adequacy, preservation, and yield of diagnostic cells. The results were analyzed by using the Pearson χ2 test. Cytomorphological details were preserved in 82/84 satisfactory morning samples and in 80/81 satisfactory fresh samples, respectively. Malignancy was detected in 37 morning samples (44%) and 25 fresh samples (30.8%). In the malignant samples, there were more abundant tumor cells in the morning samples than in the fresh samples (65 and 40%, respectively) with a 2+ cellularity in the morning samples. The morning samples showed a better cell yield (25% more), with a 13% increase in the rate of detection of malignancy and an increased sensitivity of 19.68% compared to the fresh samples. Adequacy and preservation was similar in both sample types. While the morning samples showed a higher sensitivity and a larger number of tumor cells than the fresh samples, the difference was not statistically significant (p < 0.054). © 2017 S. Karger AG, Basel.

  17. Oxytocin via Uniject (a prefilled single-use injection) versus oral misoprostol for prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled trial.

    Science.gov (United States)

    Diop, Ayisha; Daff, Bocar; Sow, Maimouna; Blum, Jennifer; Diagne, Mamadou; Sloan, Nancy L; Winikoff, Beverly

    2016-01-01

    Access to injectable uterotonics for management of postpartum haemorrhage remains limited in Senegal outside health facilities, and misoprostol and oxytocin delivered via Uniject have been deemed viable alternatives in community settings. We aimed to compare the efficacy of these drugs when delivered by auxiliary midwives at maternity huts. We did an unmasked cluster-randomised controlled trial at maternity huts in three districts in Senegal. Maternity huts with auxiliary midwives located 3-21 km from the closest referral centre were randomly assigned (1:1; via a computer-generated random allocation overseen by Gynuity Health Projects) to either 600 μg oral misoprostol or 10 IU oxytocin in Uniject (intramuscular), stratified by reported previous year clinic volume (deliveries) and geographical location (inland or coastal). Maternity huts that had been included in a previous study of misoprostol for prevention of postpartum haemorrhage were excluded to prevent contamination. Pregnant women in their third trimester were screened for eligibility either during community outreach or at home-based prenatal visits. Only women delivered by the auxiliary midwives in the maternity huts were eligible for the study. Women with known allergies to prostaglandins or pregnancy complications were excluded. The primary outcome was mean change in haemoglobin concentration measured during the third trimester and after delivery. This study was registered with ClinicalTrials.gov, number NCT01713153. 28 maternity hut clusters were randomly assigned-14 to the misoprostol group and 14 to the oxytocin group. Between June 6, 2012, and Sept 21, 2013, 1820 women were recruited. 647 women in the misoprostol group and 402 in the oxytocin group received study drug and had recorded pre-delivery and post-delivery haemoglobin concentrations, and overall 1412 women delivered in the study maternity huts. The mean change in haemoglobin concentrations was 3·5 g/L (SD 16·1) in the misoprostol group

  18. Relative bioavailability of two oral formulations of risperidone 2 mg: A single-dose, randomized-sequence, open-label, two-period crossover comparison in healthy Brazilian volunteers.

    Science.gov (United States)

    Belotto, Karisa Cristina Rodrigues; Raposo, Nádia Rezende Barbosa; Ferreira, Aline Siqueira; Gattaz, Wagner Farid

    2010-11-01

    Risperidone (RSP) is a benzisoxazole antipsychotic agent used to treat schizophrenia and other psychiatric illnesses in adults and children (including those with autism). After oral administration, RSP is completely absorbed from the gastrointestinal tract and undergoes hydroxylation to yield 9-hydroxyrisperidone (9-OH-RSP), an active metabolite that has a pharmacologic profile and potency similar to RSP. The aims of this study were to compare the relative bioavailability of a pharmaceutical-equivalent (test) formulation with a reference formulation of oral RSP 2 mg, both available commercially on the Brazilian pharmaceutical market, and to generate data regarding the oral bioavailability of the tested drug in healthy Brazilian volunteers. This single-dose, randomized-sequence, open-label, 2-period crossover study was conducted in healthy Brazilian volunteers from August to December 2008. Subjects were randomly assigned to receive the test formulation followed by the reference formulation or vice versa, with a 30-day washout period between doses. Study drugs were administered after a 12-hour overnight fast. For pharmacokinetic analysis, blood samples were drawn at 0 (baseline), 0.25, 0.5, 1, 1.5, 3, 5, 8, 12, 24, 48, 72, 96, and 120 hours after administration. Plasma concentrations of RSP and 9-OH-RSP were determined using LC-MS/MS. The test and reference formulations were to be considered bioequivalent if the 90% CIs for the geometric mean test/reference ratios were within a predetermined range of 80% to 125%, in accordance with the policies of the Brazilian Sanitary Surveillance Agency and the US Food and Drug Administration. Tolerability was determined using clinical assessments, monitoring of vital signs, analysis of laboratory test results, and subject interviews regarding adverse events. A total of 22 subjects were enrolled (11 men, 11 women; mean [SD] age, 32 [12] years [range, 1858 years]; weight, 70.4 [11.9] kg [range, 50-103 kg]; height, 1.67 [0.08] m

  19. Pharmacokinetics of a Single Oral Dose of the MEK1/2 Inhibitor Selumetinib in Subjects With End-Stage Renal Disease or Varying Degrees of Hepatic Impairment Compared With Healthy Subjects.

    Science.gov (United States)

    Dymond, Angela W; Martin, Paul; So, Karen; Huang, Yifan; Severin, Paul; Holmes, Victoria; Mariani, Gabriella; Marbury, Thomas

    2017-05-01

    Two phase I open-label studies were conducted to investigate the pharmacokinetics (PK), safety, and tolerability of single oral doses of selumetinib in subjects with end-stage renal disease (ESRD) undergoing hemodialysis and subjects with varying degrees of hepatic impairment; both studies included a matched control group comprised of healthy individuals. In the renal impairment study, subjects received single doses of selumetinib 50 mg; those with ESRD received selumetinib before and after dialysis (with a between-treatment washout period of ≥7 days). In the hepatic impairment study, subjects received varying single doses of selumetinib (20-50 mg) depending on liver dysfunction (mild, moderate, or severe as per Child-Pugh classification). PK, safety, and tolerability data were collected from both studies. Overall, 24 subjects were included in the renal impairment study (ESRD, N = 12; healthy subjects, N = 12). Selumetinib exposure (AUC and C max ) was not increased in the ESRD group vs healthy subjects. Selumetinib exposure was lower when selumetinib was dosed before vs after dialysis, although individual exposure was variable. Overall, 32 subjects were included in the hepatic impairment study (mild, moderate, and severe impairment, N = 8 per group; healthy subjects, N = 8). Generally, dose-normalized total selumetinib exposure was increased by 25% to 59% in subjects with moderate and severe hepatic impairment compared with healthy subjects. Increasing Child-Pugh score, decreasing serum albumin, and increasing prothrombin time correlated with increasing unbound selumetinib exposure. In both studies, selumetinib was well tolerated with no new safety concerns. These studies will inform dose adjustment considerations in patients. © 2016, The Authors. The Journal of Clinical Pharmacology Published by Wiley Periodicals, Inc. on behalf of American College of Clinical Pharmacology.

  20. Comparison of the 'sniffing the morning air' position and simple head extension for glottic visualization during direct laryngoscopy.

    Science.gov (United States)

    Nur Hafiizhoh, A H; Choy, Choy Yin

    2014-02-01

    This was a prospective randomized single-blinded clinical trial comparing the glottic views obtained during direct laryngoscopy between the 'sniffing the morning air' position and simple head extension. A sample of 378 patients, aged 18 to 75 years old with ASA physical status I or II, scheduled for elective surgery under general anesthesia with endotracheal intubation, were randomized into 2 groups. Group A used the sniffing position during the first laryngoscopy while Group B was put in simple head extension position. Positions were then interchanged for the second laryngoscopy. Sniffing position was obtained by placing a 7 cm height non-compressible cushion under the patient's head. In simple head extension, patient's head was placed flat. Glottic visualization was assessed based on the Cormack & Lehane scale. Intubation was performed after second laryngoscopy and success rate of first attempt intubation was compared. The distribution of patients with different Cormack & Lehane scores between the two intubation positions were significantly different (p Cormack & Lehane scores in 109 (57.7%) patients, no change in 75 (39.7%) or worsening in 5 (4.8%) patients. Successful intubation at first attempt was better (p < 0.05) with Group A: 156 (83.5%) while Group B: 121 (64.0%). Sniffing position provided better glottic visualization score and increased the successful rate of intubation as compared to simple head extension.

  1. Supersaturation, nucleation, and crystal growth during single- and biphasic dissolution of amorphous solid dispersions: polymer effects and implications for oral bioavailability enhancement of poorly water soluble drugs.

    Science.gov (United States)

    Sarode, Ashish L; Wang, Peng; Obara, Sakae; Worthen, David R

    2014-04-01

    The influence of polymers on the dissolution, supersaturation, crystallization, and partitioning of poorly water soluble compounds in biphasic media was evaluated. Amorphous solid dispersions (ASDs) containing felodipine (FLD) and itraconazole (ITZ) were prepared by hot melt mixing (HMM) using various polymers. The ASDs were analyzed using powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC), and HPLC. Amorphous drug conversion was confirmed using DSC and PXRD, and drug stability by HPLC. Single- and biphasic dissolution studies of the ASDs with concurrent dynamic light scattering (DLS) and polarized light microscopic (PLM) analysis of precipitated drugs were performed. HPLC revealed no HMM-induced drug degradation. Maximum partitioning into the organic phase was dependent upon the degree of supersaturation. Although the highest supersaturation of FLD was attained using Eudragit® EPO and AQOAT® AS-LF with better nucleation and crystal growth inhibition using the latter, higher partitioning of the drug into the organic phase was achieved using Pharmacoat® 603 and Kollidon® VA-64 by maintaining supersaturation below critical nucleation. Critical supersaturation for ITZ was surpassed using all of the polymers, and partitioning was dependent upon nucleation and crystal growth inhibition in the order of Pharmacoat® 603>Eudragit® L-100-55>AQOAT® AS-LF. HMM drug-polymer systems that prevent drug nucleation by staying below critical supersaturation are more effective for partitioning than those that achieve the highest supersaturation. Copyright © 2013 Elsevier B.V. All rights reserved.

  2. Concentrations of moxifloxacin in serum and pulmonary compartments following a single 400 mg oral dose in patients undergoing fibre-optic bronchoscopy.

    Science.gov (United States)

    Soman, A; Honeybourne, D; Andrews, J; Jevons, G; Wise, R

    1999-12-01

    The concentrations of moxifloxacin achieved after a single 400 mg dose were measured in serum, epithelial lining fluid (ELF), alveolar macrophages (AM) and bronchial mucosa (BM). Concentrations were determined using a microbiological assay. Nineteen patients undergoing fibre-optic bronchoscopy were studied. Mean serum, ELF, AM and BM concentrations at 2.2, 12 and 24 h were as follows: 2.2 h: 3.2 mg/L, 20.7 mg/L, 56.7 mg/L, 5.4 mg/kg; 12 h: 1.1 mg/L, 5.9 mg/L, 54.1 mg/L, 2.0 mg/kg; 24 h: 0.5 mg/L, 3.6 mg/L, 35.9 mg/L, 1.1 mg/kg, respectively. These concentrations exceed the MIC(90)s for common respiratory pathogens such as Streptococcus pneumoniae (0.25 mg/L), Haemophilus influenzae (0.03 mg/L), Moraxella catarrhalis (0.12 mg/L), Chlamydia pneumoniae (0.12 mg/L) and Mycoplasma pneumoniae (0. 12 mg/L) and indicate that moxifloxacin should be effective in the treatment of community-acquired, lower respiratory tract infections.

  3. Effect of a single overnight topical application of miconazole nitrate paste on acne papules.

    Science.gov (United States)

    Flagothier, Caroline; Vroome, Valérie; Borgers, Marcel; Wang, Xuemin; Cauwenbergh, Geert; Piérard, Gérald E

    2006-03-01

    The classical management of acne calls for prolonged oral and/or topical treatments; however, some patients request a rapid effect to make the papules disappear within a few hours or days. To test the effect of a single overnight application of a paste containing 0.25% miconazole nitrate on acne papules, and comparison with the effect of the same but unmedicated paste. Narrow-band reflectance spectroscopy was used to assess the changes in E index (erythema) after overnight application of the pastes. In the first study, a total of 117 acne papules were assessed in 15 adolescents. Measurements of the E index were performed at 24-h intervals for 4 days on acne papules and the surrounding normal-looking skin. The last two assessments were performed the mornings preceding and following, respectively, a single application of the medicated paste. The second part of the study consisted of a double-blind, split-face study on 25 adolescents with acne. They applied each of the two formulations on a randomized part of the forehead. A total of 161 acne papules received the medicated paste and 160 received the same but unmedicated paste. Measurements were performed the mornings before and after the overnight treatment. In the first part of the study, no significant daily difference was observed between the three series of pretreatment E indices, on both acne papules and normal skin. The treatment did not affect the E index of normal skin. By contrast, it decreased significantly the E index of the acne papules. The second part of the study also showed that the medicated paste significantly decreased the E index of acne papules. This effect was significantly (P < 0.05) superior to that of the unmedicated paste. A single overnight application of miconazole nitrate paste appears to reduce the erythematous aspect of acne papules.

  4. Association between glycemic control and morning blood surge with vascular endothelial dysfunction in type 2 diabetes mellitus patients

    Directory of Open Access Journals (Sweden)

    Rama Kumari Nuthalapati

    2016-01-01

    Full Text Available Objective: Morning blood pressure surge (MBPS is an independent predictor of cardiovascular events. However, little is known about the association between glycemic control and MBPS, and its effect on vascular injury in patients with type 2 diabetes mellitus (T2DM. The current study examined the association between glycemic control and MBPS and the involvement of MBPS in the development of vascular dysfunction in T2DM patients. Materials and Methods: One hundred and twenty-two consecutive T2DM outpatients from the Department of Cardiology and Endocrinology were enrolled in this study. We did MBPS in T2DM patients, 85 (male (69.7% patients and 37 (female patients (30.3%; mean age 60.1 ± 9.39; (n = 122 using 24 h ambulatory blood pressure monitoring and assessed vascular function by brachial artery flow-mediated dilation (FMD and nitroglycerin-mediated dilation (NMD. Results: The correlation between MBPS and various clinical variables were examined by single regression analysis in all subjects. MBPS showed significant and positive correlation with pulse rate (P = 0.01, fasting blood sugar (P = 0.002, and postprandial blood sugar (P = 0.05. To further confirm the association of insulin resistance (IR with MBPS in T2DM patients, we examined the correlation between homeostasis model assessment-IR (HOMA-IR, an established marker of IR and MBPS in diabetic (DM patients who were not taking insulin no significant association with MBPS in T2DM patients (P = 0.41, angiotensin-converting enzyme/angiotensin receptor blocker (P = 0.07. We examined the relationship between MBPS and vascular injury by measuring endothelium-dependent FMD and endothelium-independent NMD in T2DM patients. Among the various traditional risk factors for atherosclerosis such as DM duration (P = 0.04, platelet reactivity (P = 0.04 and morning surge (P = 0.002 emerged as significant factors. HOMA-IR was a negative correlation with FMD. Conclusions: The current study demonstrated that

  5. Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR in healthy adults age 18-45.

    Science.gov (United States)

    McCarty, James M; Lock, Michael D; Hunt, Kristin M; Simon, Jakub K; Gurwith, Marc

    2018-02-01

    The attenuated recombinant Vibrio cholerae O1 vaccine strain CVD 103-HgR, re-developed as PXVX0200, elicits a rapid serum vibriocidal antibody (SVA) response and protects against cholera diarrhea in volunteer challenge studies. We performed a phase 3, placebo controlled, double blind, multi-center study to further assess the safety, immunogenicity, and lot-to-lot consistency of PXVX0200. Adult volunteers 18-45 years of age were randomized 8:1 to receive a single dose of 1 × 10 9 CFU of PXVX0200 from three production lots or saline placebo. Immunogenicity endpoints included SVA and anti-cholera toxin (CT) antibody levels on days 1, 11, 29, 91 and 181. Safety was assessed by comparing solicited signs and symptoms on days 1-8, unsolicited adverse events through day 29 and serious adverse events through day 181. A total of 3146 participants were enrolled, including 2795 vaccine and 351 placebo recipients. The SVA seroconversion rates at day 11 were 94% and 4% in the PXVX0200 and placebo recipients, respectively (P < .0001). Cumulative SVA seroconversion occurred among 96% of vaccine recipients. PXVX0200 SVA GMTs peaked on day 11 and remained significantly higher than placebo through day 181 while the fold-rise over baseline in PXVX0200 anti-CT antibody was significantly greater than placebo at every post-vaccination time point. Most reactogenicity was mild and resolved within 1-3 days with headache and diarrhea more frequently reported in PXVX0200 recipients. There were no differences in unsolicited adverse events and no study-related serious adverse events. Immunogenicity and safety endpoints were equivalent between the three production lots. PXVX0200 is immunogenic and well tolerated across multiple production lots. Clinicaltrials.gov NCT02094586. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  6. Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of an Omega-3-Carboxylic Acid Formulation in Healthy Male Japanese Subjects: A Phase 1 Single-Blind, Randomized, Placebo-Controlled Trial.

    Science.gov (United States)

    Noda, Yoshinori; Nilsson, Catarina; Shimada, Hitoshi; Kim, Hyosung; Lundström, Torbjörn; Yajima, Toshitaka

    2018-02-01

    OM3-CA (omega-3-carboxylic acids) is a complex mixture of omega-3 carboxylic acids, particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which is approved in the United States for the treatment of hypertriglyceridemia. As part of its clinical development in Japan, we performed a phase 1 study to investigate the safety, tolerability, and pharmacokinetics after single and multiple doses of OM3-CA in healthy male Japanese subjects. Eighteen Japanese subjects were allocated to receive 2 or 4 g/day OM3-CA, or placebo (n = 6 per group). In addition, 6 white subjects received 4 g/day OM3-CA. The primary objective was to determine the safety and tolerability of OM3-CA. Plasma concentrations of EPA and DHA were adjusted for baseline values for pharmacokinetic analysis. Overall, OM3-CA was well tolerated in healthy Japanese subjects. Two Japanese subjects in each group and 5 white subjects experienced adverse events (AEs). Alanine aminotransferase increase was the most common AE in Japanese subjects, also seen with placebo, and diarrhea was the most common AE in white subjects. The maximum plasma concentrations of EPA and DHA were observed 5-6 hours postdose. The pharmacokinetic profiles of EPA and DHA after administration of OM3-CA were comparable between Japanese and white subjects. © 2017, The American College of Clinical Pharmacology.

  7. Randomized, Single-Blind, Parallel Clinical Trial on Efficacy of Oral Prednisolone Versus Intramuscular Corticotropin: A 12-Month Assessment of Spasm Control in West Syndrome.

    Science.gov (United States)

    Wanigasinghe, Jithangi; Arambepola, Carukshi; Ranganathan, Shalini Sri; Sumanasena, Samanmali

    2017-11-01

    We earlier completed a single-blind, parallel-group, randomized clinical trial to test the null hypothesis that adrenocorticotropic hormone (ACTH) is not superior to high-dose prednisolone for short-term control of West syndrome. We now present long-term follow-up data for spasm control for individuals who completed this earlier trial. Infants with untreated West syndrome were randomized to receive 14 days of prednisolone (40 to 60 mg/day) or intramuscular long-acting ACTH (40 to 60 IU every other day). They were evaluated at three, six, and 12 months to evaluate long-term spasm control. The total number of infants treated was 97 (48 prednisolone; 49 ACTH). All completed the treatment course. Eighty-five, 82, and 76 children were available for follow-up at three, six, and 12 months. The number lost to follow-up at each interval was not statistically different. Likelihood of spasm freedom at three months was significantly higher for prednisolone (64.6%) than for ACTH (38.8%) (P = 0.01; odds ratio = 2.9; 95% confidence interval = 1.3 to 6.6). At six months (P = 0.19) and twelve months (P = 0.13), the control of spasms was not statistically different, although a trend in favor of prednisolone was documented at both of these time points (58.3% versus 44.9% for ACTH at six months and 56.2% versus 40.8% with ACTH at 12 months). After initial remission by day 14 (n = 46), the likelihood of a relapse within the next 12 months was not statistically different between the two treatment groups (P = 0.1). Control of spasms at three months was significantly better if initially treated with prednisolone. Control of spasms at six and 12 months was not significantly different despite a trend favoring prednisolone. Risk of relapse following initial remission was similar in the two groups. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. The relationship between a blunted morning surge and a reversed nocturnal blood pressure dipping or "riser" pattern.

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    Fujiwara, Takeshi; Tomitani, Naoko; Sato, Keiko; Okura, Ayako; Suzuki, Noriyuki; Kario, Kazuomi

    2017-11-01

    The authors sought to determine the association between the blunted morning blood pressure (BP) surge and nocturnal BP dipping of the "riser" pattern in 501 patients with hypertension enrolled in the ACHIEVE-ONE (Ambulatory Blood Pressure Control and Home Blood Pressure [Morning and Evening] Lowering by the N-Channel Blocker Cilnidipine) trial. The patients' sleep-trough morning BP surge and prewaking surge were calculated and then classified according to their nocturnal systolic BP reduction pattern as extreme dippers, dippers, nondippers, and risers. The prevalence of the riser pattern was significantly higher in both the lowest sleep-trough morning BP surge decile and the prewaking surge decile (blunted surge group) compared with the remaining deciles (56.0% vs 10.4% [Pmorning BP surge (odds ratio, 73.3; Pmorning BP surges may account for the cardiovascular risk previously reported in such patients. ©2017 Wiley Periodicals, Inc.

  9. Oral candidiasis.

    Science.gov (United States)

    Millsop, Jillian W; Fazel, Nasim

    2016-01-01

    Oral candidiasis (OC) is a common fungal disease encountered in dermatology, most commonly caused by an overgrowth of Candida albicans in the mouth. Although thrush is a well-recognized presentation of OC, it behooves clinicians to be aware of the many other presentations of this disease and how to accurately diagnose and manage these cases. The clinical presentations of OC can be broadly classified as white or erythematous candidiasis, with various subtypes in each category. The treatments include appropriate oral hygiene, topical agents, and systemic medications. This review focuses on the various clinical presentations of OC and treatment options. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. Oral myiasis

    Directory of Open Access Journals (Sweden)

    Treville Pereira

    2010-01-01

    Full Text Available Myiasis is a relatively rare condition arising from the invasion of body tissues or cavities of living animals or humans by maggots or larvae of certain species of flies. It is an uncommon clinical condition, being more frequent in underdeveloped countries and hot climate regions, and is associated with poor hygiene, suppurative oral lesions; alcoholism and senility. Its diagnosis is made basically by the presence of larvae. The present article reports a case of oral myiasis involving 20 larvae in a patient with neurological deficiency.

  11. Petrogenesis of Cenozoic, alkalic volcanic lineages at Mount Morning, West Antarctica and their entrained lithospheric mantle xenoliths: Lithospheric versus asthenospheric mantle sources

    Science.gov (United States)

    Martin, Adam P.; Cooper, Alan F.; Price, Richard C.

    2013-12-01

    Two volcanic lineages are identified at Mount Morning, a Cenozoic to recent, eruptive centre in the Ross Sea, West Antarctica, which is part of the McMurdo Volcanic Group. Both the older (at least 18.7-11.4 Ma), mildly alkalic, nepheline- or quartz-normative Mason Spur Lineage, and the younger (at least 6-0.02 Ma), nepheline normative, strongly alkalic Riviera Ridge Lineage evolved by fractional crystallization from nominally anhydrous (Zealandia and eastern Australia share common chemical and isotopic source characteristics and they have been argued to collectively constitute a single diffuse alkaline magmatic province (DAMP). Source characteristic similarities suggest DAMP volcanic rocks inherit at least some of their trace element and isotopic characteristics from the lithospheric mantle. Super-chondritic Nb/Ta values measured in some SCLM xenoliths and volcanic rocks at Mount Morning, and in volcanic rocks across the DAMP, can be explained by addition of ⩽5 wt% carbonatite to the source. The DAMP SCLM is a significant Nb reservoir that offers an explanation for the Nb paradox.

  12. Influence of rheumatoid arthritis-related morning stiffness on productivity at work: results from a survey in 11 European countries.

    Science.gov (United States)

    Mattila, Kalle; Buttgereit, Frank; Tuominen, Risto

    2015-11-01

    The objective of this study was to evaluate the influence of morning stiffness on productivity at work and to estimate the work-related economic consequences of morning stiffness among patients with RA-related morning stiffness in 11 European countries. The original sample comprised 1061 RA patients from 11 European countries (Belgium, Denmark, Finland, France, Germany, Italy, Norway, Poland, Spain, Sweden and UK). They had been diagnosed with RA and experience morning stiffness three or more times per week. Data were collected by interviews. Women comprised 77.9 % of the sample, the average age was 50.4 years, and 84.3 % had RA diagnosed for more than 2 years. Overall costs of RA-related morning stiffness was calculated to be 27,712€ per patient per year, varying from 4965€ in Spain to 66,706€ in Norway. On average, 96 % of the overall production losses were attributed to early retirement, with a markedly lower level (77 %) in Italy than in other countries (p morning stiffness and productivity losses due to late work arrivals and working while sick showed considerable variation across the countries represented in the study. Overall, the average annual cost of late arrivals (0.8 % of the total costs) was approximately half of the costs attributed to sick leave (1.7 %) and working while sick (1.5 %). Morning stiffness due to RA causes significant production losses and is a significant cost burden throughout Europe. There seem to be notable differences in the impact of morning stiffness on productivity between European countries.

  13. Verification of impact of morning showering and mist sauna bathing on human physiological functions and work efficiency during the day.

    Science.gov (United States)

    Lee, Soomin; Fujimura, Hiroko; Shimomura, Yoshihiro; Katsuura, Tetsuo

    2015-09-01

    Recently, a growing number in Japan are switching to taking baths in the morning (morning bathing). However, the effects of the morning bathing on human physiological functions and work efficiency have not yet been revealed. Then, we hypothesized that the effect of morning bathing on physiological functions would be different from those of night bathing. In this study, we measured the physiological functions and work efficiency during the day following the morning bathing (7:10-7:20) including showering, mist sauna bathing, and no bathing as a control. Ten male healthy young adults participated in this study as the subjects. We evaluated the rectal temperature (Tre), skin temperature (Tsk), heart rate (HR), heart rate variability (HRV), blood pressure (BP), the relative power density of the alpha wave (α-wave ratio) of electroencephalogram, alpha attenuation coefficient (AAC), and the error rate of the task performance. As a result, we found that the HR after the mist sauna bathing was significantly lower than those after no bathing rest 3 (11:00). Furthermore, we verified that the α-wave ratio of the Pz after the mist sauna bathing was significantly lower than those after no bathing during the task 6 (15:00). On the other hand, the α-wave ratio of the Pz after the mist sauna bathing was significantly higher than those after showering during the rest 3 (11:00). Tsk after the mist sauna bathing was higher than those after the showering at 9:00 and 15:00. In addition, the error rate of the task performance after the mist sauna bathing was lower than those after no bathing and showering at 14:00. This study concludes that a morning mist sauna is safe and maintains both skin temperature compared to other bathing methods. Moreover, it is presumed that the morning mist sauna bathing improves work efficiency comparing other bathing methods during the task period of the day following the morning bathing.

  14. Relationship of Morning Cortisol to Circadian Phase and Rising Time in Young Adults with Delayed Sleep Times

    Directory of Open Access Journals (Sweden)

    Mark S. Rea

    2012-01-01

    Full Text Available The present study was aimed at further elucidating the relationship between circadian phase, rising time, and the morning cortisol awakening response (CAR. The results presented here are a secondary analysis of experimental data obtained from a study of advanced sleep-wake schedules and light exposures on circadian phase advances measured by dim-light melatonin onset (DLMO. The present results demonstrate that morning CAR is strongly related to rising time and more weakly related to DLMO phase.

  15. The chemical composition and technological properties of milk obtained from the morning and evening milking

    Directory of Open Access Journals (Sweden)

    Martin Skýpala

    2008-01-01

    Full Text Available Milk yield varies during lactation, following what is termed a lactation curve. ŽIŽLAVSKÝ and MIKŠÍK (1988 recorded changes in milk yield within a day, too. TEPLÝ et al. (1979 a KOUŘIMSKÁ et al. (2007 published variation within a day ± 1.10 kg in milk yield, ± 0.75 % in milk fat content and ± 0.20 % in milk protein content. Milk yield of cows can be expressed in many different ways, for instance, in kilograms per lactation or in kilograms per day. A practical parameter describing milk production is milk yield (kg per milking.The object of experiment were 12 cows of Holstein cattle on the first lactation from the 100-day of lactation to 200-day of lactation. The samples of milk were collected from January to May 2007, once a month from the morning and evening milking (milking interval 12 h ± 15 min.. The following parameters were monitored: milk production – milk yield (kg, milk protein production (kg, milk fat production (kg; milk composition – milk protein content (%, milk fat content (%, lactose content (%, milk solids-not-fat content (%, milk total solids content (%; technological properties of milk – ti­tra­tab­le acidity (SH, active acidity (pH, rennet coagulation time (s, quality of curd (class and somatic cell count as a parameter of udder health.Highly significant differences were found (P < 0.01 between morning milk yield (15.7 kg and evening milk yield (13.8 kg, between morning milk protein production (0.51 kg and evening milk protein production (0.45 kg and between evening milk fat content (4.41 % and morning milk fat content (3.95 %. A significant difference (P < 0.05 was found between morning milk total solids content (12.62 % and evening milk total solids content (12.07 %. No significant differences were found between morning (M and evening (E values of the remaining parameters: milk fat production (M 0.62 kg; E 0.60 kg, milk protein content (M 3.24 %; E 3.27 %, milk lactose content (M 4.78 %; E 4.86 %, milk

  16. Herbage intake and ruminal digestion of dairy cows grazed on perennial ryegrass pasture either in the morning or evening.

    Science.gov (United States)

    Ueda, Koichiro; Mitani, Tomohiro; Kondo, Seiji

    2016-08-01

    This study aimed to clarify diurnal fluctuations of herbage intake, ruminal fermentation of herbage carbohydrates and proteins, and digesta particulate weight in the rumen of grazing dairy cows. Six ruminally cannulated, non-lactating dairy cows were grazed on perennial ryegrass/white clover pasture either in the morning (04.00 to 08.00 hours) or the evening (16.00 to 20.00 hours). Cows grazed in the evening spent more time (P morning. Higher (P morning. Although cows grazed in the evening ingested more crude protein compared with cows grazed in the morning, no significant difference in NH3 -N concentratio