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Sample records for 3-way crossover study

  1. Colloidal submicron-particle curcumin exhibits high absorption efficiency-a double-blind, 3-way crossover study.

    PubMed

    Sunagawa, Yoichi; Hirano, Sae; Katanasaka, Yasufumi; Miyazaki, Yusuke; Funamoto, Masafumi; Okamura, Nobuko; Hojo, Yuya; Suzuki, Hidetoshi; Doi, Osamu; Yokoji, Tsunehiro; Morimoto, Eriko; Takashi, Tsukasa; Ozawa, Hitomi; Imaizumi, Atsushi; Ueno, Morio; Kakeya, Hideaki; Shimatsu, Akira; Wada, Hiromichi; Hasegawa, Koji; Morimoto, Tatsuya

    2015-01-01

    Curcumin is a major constituent of the spice turmeric and has various biological activities, including anticancer, antioxidant, and anti-inflammatory properties, as well as alcohol detoxification. However, because of its poor absorption efficiency, it is difficult for orally administered curcumin to reach blood levels sufficient to exert its bioactivities. To overcome this problem, several curcumin preparations with a drug-delivery system (DDS) have been developed to increase the bioavailability of curcumin after oral administration, and tested as functional foods and potential medical agents in humans. We have also produced capsules containing Theracurmin, curcumin dispersed with colloidal submicron-particles. To evaluate the absorption efficiency of three types of DDS curcumin, we performed a double-blind, 3-way crossover study. We compared plasma curcumin levels after the administration of Theracurmin and 2 other capsule types of curcumin with DDS, BCM-95 (micronized curcumin with turmeric essential oils) and Meriva (curcumin-phospholipid). Nine healthy subjects (male/female=5/4, age: 24-32 y old) were administered these 3 preparations of DDS curcumin, at commonly used dosages. Six capsules of Theracurmin, 1 capsule of BCM-95, and 2 capsules of Meriva contain 182.4 ± 1.0, 279.3 ± 10.7, and 152.5 ± 20.3 mg of curcumin, respectively. The maximal plasma curcumin concentration (0-24 h) of Theracurmin was 10.7 to 5.6 times higher than those of BCM-95 and Meriva, respectively. Moreover, the area under the blood concentration-time curve at 0-24 h was found to be 11.0- and 4.6-fold higher with Theracurmin than BCM-95 and Meriva, respectively. These data indicate that Theracurmin exhibits a much higher absorption efficiency than other curcumin DDS preparations.

  2. Influence of an antivertiginous combination preparation of cinnarizine and dimenhydrinate on event-related potentials, reaction time and psychomotor performance--a randomized, double-blind, 3-way crossover study in healthy volunteers.

    PubMed

    Philipova, D; Tzenova, B; Iwanowitsch, A; Bognar-Steinberg, I

    2004-04-01

    In the present comparative, double-blind, 3-way crossover study, possible effects of an antivertiginous combination preparation on event-related potentials (ERPs) and performance were investigated. Twenty-one healthy volunteers received 4 doses (within 24 h) of a fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg (Arlevert, ARL), dimenhydrinate 50 mg, or a placebo, in randomized order at 1-week intervals. Auditory event-related potentials (ERPs), reaction time (RT) and psychometric tests were assessed before as well as 60 and 150 minutes after the intake of the 1st (Day 1) and the 4th (Day 2) dose of study medication. The evaluation was primarily based on the difference in the outcomes measured 150 min after the 4th dose (t5) and those before the start of medication intake (t0). None of the medications affected the latency and amplitude of the sensory ERP component N100, neither under passive listening nor under discrimination task conditions. The latency of P300 in response to the rare target tones (oddball paradigm and binary series), showed significant (p < 0.05) delays after 4 doses of dimenhydrinate (18-24 ms), and no significant differences between ARL (3-17 ms) and either dimenhydrinate or placebo (4-13 ms). Responses to nontarget tones remained almost unaffected after medication intake. The secondary analysis of the P300 amplitude showed the greatest decreases under DH in both active series, with no significant differences between ARL and either DH or placebo. The 3 medications did not significantly prolong RT nor did they impair the performance of psychometric tests, or cause significant shifts of current mood. The combination preparation ARL showed the lowest rate of adverse events (n = 1), followed by dimenhydrinate (n = 3) and placebo (n = 6). Two subjects withdrew because of adverse events, both after the intake of placebo. In conclusion, the results gave no evidence for an impairment of central information processing and psychomotor

  3. A randomized, double-blind, positive-controlled, 3-way cross-over human experimental pain study of a TRPV1 antagonist (V116517) in healthy volunteers and comparison with preclinical profile.

    PubMed

    Arendt-Nielsen, Lars; Harris, Steve; Whiteside, Garth T; Hummel, Michele; Knappenberger, Terri; OʼKeefe, Sarah; Kapil, Ram; Kyle, Don

    2016-09-01

    This experimental, translational, experimental pain, single-center, randomized, double-blind, single-dose, 3-treatment, 3-period cross-over proof-of-concept volunteer trial studied the efficacy of a novel TRPV1 antagonist (V116517) on capsaicin- and UV-B-induced hyperalgesia. Heat and pressure pain thresholds, von Frey stimulus-response functions, and neurogenic inflammation were assessed together with safety. Each treatment period was 4 days. The 3 single oral treatments were 300 mg V116517, 400 mg celecoxib (a COX-2 inhibitor), and placebo. The heat pain detection and tolerance thresholds were increased significantly (P < 0.0001) by V116517. Heat pain detection and tolerance thresholds showed significantly less capsaicin hyperalgesia after V116517 (P = 0.004 and P < 0.0001, respectively). Celecoxib reduced UV-B-provoked pressure pain sensitization (P = 0.01). Laser Doppler flowmetry and erythema index after UV-B were significantly (P < 0.0001) reduced by celecoxib. Stimulus-response function in capsaicin-treated areas showed significant differences between both celecoxib and placebo and between V116517 and placebo. The body temperature showed no change, and no side effects were reported for any of the treatments. The TRPV1 antagonists and the COX-2 inhibitor showed different antihyperalgesic profiles indicating different clinical targets. In addition, the preclinical profile of V116517 in rat models of UV-B and capsaicin-induced hypersensitivity was compared with the human experimental data and overall demonstrated an alignment between 2 of the 3 end points tested. The TRPV1 antagonist showed a potent antihyperalgesic action without changing the body temperature but heat analgesia may be a potential safety issue. PMID:27168361

  4. Crossover studies with survival outcomes.

    PubMed

    Buyze, Jozefien; Goetghebeur, Els

    2013-12-01

    Crossover designs are well known to have major advantages when comparing the effect of two treatments which do not interact. With a right-censored survival endpoint, however, this design is quickly abandoned in favour of the more costly parallel design. Motivated by human immunodeficiency virus (HIV) prevention studies which lacked power, we evaluate what may be gained in this setting and compare parallel with crossover designs. In a heterogeneous population, we find and explain a substantial increase in power for the crossover study using a non-parametric logrank test. With frailties in a proportional hazards model, crossover designs equally lead to substantially smaller variance for the subject-specific hazard ratio (HR), while the population-averaged HR sees negligible gain. Its efficiency benefit is recovered when the population-averaged HR is reconstructed from estimated subject-specific hazard rates. We derive the time point for treatment crossover that optimizes efficiency and end with the analysis of two recent HIV prevention trials. We find that a Cellulose sulphate trial could have hardly gained efficiency from a crossover design, while a Nonoxynol-9 trial stood to gain substantial power. We conclude that there is a role for effective crossover designs in important classes of survival problems. PMID:21715438

  5. A Single-Center, Open-Label, 3-Way Crossover Trial to Determine the Pharmacokinetic and Pharmacodynamic Interaction Between Nebivolol and Valsartan in Healthy Volunteers at Steady State

    PubMed Central

    Chen, Chun Lin; Desai-Krieger, Daksha; Ortiz, Stephan; Kerolous, Majid; Wright, Harold M.; Ghahramani, Parviz

    2015-01-01

    Combining different classes of antihypertensives is more effective for reducing blood pressure (BP) than increasing the dose of monotherapies. The aims of this phase I study were to investigate pharmacokinetic and pharmacodynamic interactions between nebivolol, a vasodilatory β1-selective blocker, and valsartan, an angiotensin II receptor blocker, and to assess safety and tolerability of the combination. This was a single-center, randomized, open-label, multiple-dose, 3-way crossover trial in 30 healthy adults aged 18–45 years. Participants were randomized into 1 of 6 treatment sequences (1:1:1:1:1:1) consisting of three 7-day treatment periods followed by a 7-day washout. Once-daily oral treatments comprised nebivolol (20 mg), valsartan (320 mg), and nebivolol–valsartan combination (20/320 mg). Outcomes included AUC0-τ,ss, Cmax,ss, Tmax,ss, changes in BP, pulse rate, plasma angiotensin II, plasma renin activity, 24-hour urinary aldosterone, and adverse events. Steady-state pharmacokinetic interactions were observed but deemed not clinically significant. Systolic and diastolic BP reduction was significantly greater with nebivolol–valsartan combination than with either monotherapy. The mean pulse rate associated with nebivolol and nebivolol–valsartan treatments was consistently lower than that associated with valsartan monotherapy. A sharp increase in mean day 7 plasma renin activity and plasma angiotensin II that occurred in valsartan-treated participants was significantly attenuated with concomitant nebivolol administration. Mean 24-hour urine aldosterone at day 7 was substantially decreased after combined treatment, as compared with either monotherapy. All treatments were safe and well tolerated. In conclusion, nebivolol and valsartan coadministration led to greater reductions in BP compared with either monotherapy; nebivolol and valsartan lower BP through complementary mechanisms. PMID:25853236

  6. A single-dose, 3-way crossover pharmacokinetic comparison between immediate-release oxycodone hydrochloride with aversion technology (IRO-A, Oxecta), IRO-a with Niacin, and Oxycodone Hydrochloride (Roxicodone) in healthy adults under fasting conditions.

    PubMed

    Leibowitz, Mark T; Zamora, Cynthia A; Brzeczko, Albert W; Stark, Jeffrey G

    2014-01-01

    Snorting and intravenous use are common routes of administration for advanced opioid abusers. A tablet form of immediate-release oxycodone (IRO) developed using Aversion Technology combines immediate release (IR) oxycodone HCl with inactive functional excipients that are intended to discourage tampering associated with intranasal and intravenous abuse (IRO-A; Oxecta, Pfizer). The purpose of this single-dose, open-label, randomized, 3-period, 3-treatment crossover study was to evaluate the bioequivalence of IRO-A to the marketed immediate-release oxycodone HCl (IRO; Roxicodone, Xanodyne Pharmaceuticals Inc., Newport, KY). IRO-A was also compared with IRO-A with niacin, a product previously developed containing the same functional excipients plus niacin as an aversive agent to discourage oral overconsumption. Healthy adults (N = 40) aged 18-55 years received single 15-mg doses of IRO-A, IRO-A with niacin (60 mg), or IRO after fasting overnight. Naltrexone was administered to diminish opioid effects. Doses were separated by a ≥7-day washout. Plasma samples taken at designated time points were analyzed using liquid chromatography with tandem mass spectrometry. Geometric mean ratios for ln-transformed parameters for IRO-A and IRO were 92%, 104%, and 104% for Cmax, AUClast (AUC is area under the concentration-time curve), and AUCinf; 90% confidence intervals were within the accepted 80%-125% range. IRO-A was also bioequivalent to IRO-A with niacin. Adverse events were mild to moderate in intensity and typical of opioid therapy (nausea, headache, vomiting). Flushing only occurred when the subjects received the IRO-A with niacin treatment (9/37 subjects). The results demonstrated that IRO-A is bioequivalent to IRO and IRO-A with niacin. With features designed to discourage tampering associated with common forms of abuse, IRO-A may provide an alternative to conventional immediate-release oxycodone formulations.

  7. Academic Crossover Study: Community Colleges, Fall 1981.

    ERIC Educational Resources Information Center

    Hawaii Univ., Honolulu. Office of Institutional Research and Analysis.

    In fall 1981, a study was conducted in Hawaii's community colleges to determine the course-taking patterns of different groups of student majors (e.g., the proportion of the liberal arts major's academic load that is taken in the humanities, natural sciences, etc.), and the client-serving patterns of different subject disciplines (e.g., the…

  8. Meige syndrome: double-blind crossover study of sodium valproate.

    PubMed Central

    Snoek, J W; van Weerden, T W; Teelken, A W; van den Burg, W; Lakke, J P

    1987-01-01

    A double-blind crossover study of sodium valproate and placebo was conducted in five patients with Meige syndrome. CSF neurotransmitter studies were performed at the end of each treatment period. GABA levels were not influenced by the administration of sodium valproate. An increase in HVA levels was observed in every patient, which may reflect an increase in central dopaminergic activity. This finding may explain the trend towards clinical deterioration which was observed during treatment with sodium valproate. Sodium valproate appears to be ineffective in Meige syndrome. PMID:3121795

  9. A Pilot Study on Culottes versus Crossover Single Stenting for True Coronary Bifurcation Lesions

    PubMed Central

    Zhang, Linlin; Zhong, Wenliang; Luo, Yukun; Chen, Lianglong

    2016-01-01

    Background The purpose of our study was to compare clinical and angiographic outcomes of planned culottes technique with that of provisional crossover single stenting in the treatment of true coronary bifurcation lesions (CBL) with drug-eluting stent (DES). Methods True CBL patients (n = 104) were randomly assigned to either the provisional stenting of the side branch (crossover group) or the culottes group. Additional side branch (SB) stenting in the crossover group was required if there was thrombolysis in myocardial infarction flow ≤ 1 flow). The primary end point was the occurrence of major adverse cardiac events (MACE) at nine months, including cardiac death, myocardial infarction, target lesion/vessel revascularization and in-stent thrombosis. The secondary end point was angiographic in-segment restenosis at nine months. Results The rate of MACE at nine months was similar between the crossover and culottes groups (7.7% vs. 7.7%, p = 1.000). Additional SB stenting in the crossover group was required in 3.8% of patients. There was one procedural occlusion of SB in the crossover group. At nine months, the rate of in-segment restenosis was similar in the parent main vessel (0% vs. 1.9%, p = 1.000), main branch (1.9% vs. 7.7%, p = 0.363) and SB (17.3% vs. 9.6%, p = 0.250) between the crossover and culottes groups, respectively. Conclusions This study demonstrated that there is no significant difference in cumulative MACE or in-segment restenosis between crossover and culottes groups. Larger randomized clinical trials are warranted to re-evaluate the outcomes of the provisional crossover stenting versus the culottes stenting techniques utilizing DES for true CBL. PMID:27471358

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

    NASA Technical Reports Server (NTRS)

    Narayanan, S. R.

    1995-01-01

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

  11. Theoretical Study of Spin Crossover in 30 Iron Complexes.

    PubMed

    Kepp, Kasper P

    2016-03-21

    Iron complexes are important spin crossover (SCO) systems with vital roles in oxidative metabolism and promising technological potential. The SCO tendency depends on the free energy balance of high- and low-spin states, which again depends on physical effects such as dispersion, relativistic effects, and vibrational entropy. This work studied 30 different iron SCO systems with experimentally known thermochemical data, using 12 different density functionals. Remarkably general entropy-enthalpy compensation across SCO systems was identified (R = 0.82, p = 0.002) that should be considered in rational SCO design. Iron(II) complexes displayed higher ΔH and ΔS values than iron(III) complexes and also less steep compensation effects. First-coordination sphere ΔS values computed from numerical frequencies reproduce most of the experimental entropy and should thus be included when modeling spin-state changes in inorganic chemistry (R = 0.52, p = 3.4 × 10(-3); standard error in TΔS ≈ 4.4 kJ/mol at 298 K vs 16 kJ/mol of total TΔS on average). Zero-point energies favored high-spin states by 9 kJ/mol on average. Interestingly, dispersion effects are surprisingly large for the SCO process (average: 9 kJ/mol, but up to 33 kJ/mol) and favor the more compact low-spin state. Relativistic effects favor low-spin by ∼9 kJ/mol on average, but up to 24 kJ/mol. B3LYP*, TPSSh, B2PLYP, and PW6B95 performed best for the typical calculation scheme that includes ZPE. However, if relativistic and dispersion effects are included, only B3LYP* remained accurate. On average, high-spin was favored by LYP by 11-15 kJ/mol relative to other correlation functionals, and by 4.2 kJ/mol per 1% HF exchange in hybrids. 13% HF exchange was optimal without dispersion, and 15% was optimal with all effects included for these systems. PMID:26913489

  12. Splitter imperfections in annular split-flow thin separation channels: experimental study of nonspecific crossover.

    PubMed

    Williams, P Stephen; Decker, Keith; Nakamura, Masayuki; Chalmers, Jeffrey J; Moore, Lee R; Zborowski, Maciej

    2003-12-01

    The separation performance of a split-flow thin (SPLITT) separation device depends on uniformity of channel thickness and the precise placement of the flow splitters at fixed distances between the channel walls. The observation of nonspecific crossover, that is, the transport of sample materials across the channel thickness without the influence of an applied field, has routinely been taken to indicate the presence of irregularities in splitter shape or placement. Computational fluid dynamics software may be used to predict the influence of splitter imperfections on nonspecific crossover, where it is assumed that sample transport is by convection alone. A previous study has shown how small inlet splitter imperfections can account for the relatively low levels of nonspecific crossover observed with typical annular SPLITT devices. This study, however, could not distinguish between the possible sources of nonspecific crossover; hydrodynamic lift or shear-induced diffusion could have contributed. To confirm the validity of the computational approach, a series of experiments has been carried out on a channel having a deliberately and severely bent splitter. Nonspecific crossover was measured for a range of inlet and outlet flow rate ratios, with the bent splitter placed at both the channel inlet and outlet. The severity of the splitter distortion was sufficient to produce significant nonspecific crossover over a wide range of flow conditions. Good agreement was found between experiment and prediction based on computational fluid dynamics, with experiment generally showing only slightly higher crossover than prediction. The quantitative agreement for this extreme case suggests that the contribution to nonspecific crossover due to geometrical imperfections can be well described using computational fluid dynamics. PMID:14640746

  13. Computational approach to the study of thermal spin crossover phenomena

    SciTech Connect

    Rudavskyi, Andrii; Broer, Ria; Sousa, Carmen

    2014-05-14

    The key parameters associated to the thermally induced spin crossover process have been calculated for a series of Fe(II) complexes with mono-, bi-, and tridentate ligands. Combination of density functional theory calculations for the geometries and for normal vibrational modes, and highly correlated wave function methods for the energies, allows us to accurately compute the entropy variation associated to the spin transition and the zero-point corrected energy difference between the low- and high-spin states. From these values, the transition temperature, T{sub 1/2}, is estimated for different compounds.

  14. A Crossover Study of Risperidone in Children, Adolescents and Adults with Mental Retardation

    ERIC Educational Resources Information Center

    Hellings, Jessica A.; Zarcone, Jennifer R.; Reese, R. Matthew; Valdovinos, Maria G.; Marquis, Janet G.; Fleming, Kandace K.; Schroeder, Stephen R.

    2006-01-01

    Risperidone has shown safety and efficacy for aggressive and destructive behaviors in short-term studies. This longer-duration study includes a broad sample. Forty subjects, aged 8-56 years (mean=22), all with mental retardation and 36 with autism spectrum disorders participated in this 22-week crossover study, with 24 weeks of open maintenance…

  15. Chorionic gonadotropin in weight control. A double-blind crossover study.

    PubMed

    Young, R L; Fuchs, R J; Woltjen, M J

    1976-11-29

    Two hundred two patients participated in a double-blind random cross-over study of the effectiveness of human chorionic gonadotropin (HCG) vs placebo in a wieght reduction program. Serial measurements were made of weight, skin-fold thickness, dropout rates, reasons for dropping out, and patient subjective response. There was no statistically significant difference between those receiving HCG vs placebo during any phase of this study (P greater than .1). PMID:792477

  16. Ketazolam once daily for spasticity: double-blind cross-over study.

    PubMed

    Basmajian, J V; Shankardass, K; Russell, D

    1986-08-01

    This double-blind cross-over study of 14 severely spastic inpatients with chronic multiple sclerosis reveals that once-daily doses of ketazolam, a new drug, are effective in reducing spasticity in a significant proportion of patients without significant side-effects. Added to the similar findings of an earlier double-blind controlled study of divided doses, the results suggest that this special feature of ketazolam provides a unique flexibility that may be exploited in individual cases.

  17. Stress as a Trigger for Relapses in IBD: A Case-Crossover Study

    PubMed Central

    Jaghult, Susanna; Saboonchi, Fredrik; Moller, Jette; Johansson, Unn-Britt; Wredling, Regina; Kapraali, Marjo

    2013-01-01

    Background It is important to identify factors that influence the risk of relapses in inflammatory bowel disease. Few studies have been conducted and with limited methodology. This prospective case-crossover study, aims to examine whether perceived stress has a short-term acute effect, namely whether it acts as a trigger, on the risk of relapse in inflammatory bowel disease. Methods Sixty patients with inflammatory bowel disease and in remission were included. The case-crossover design was employed, which is an epidemiological design developed to study triggers for acute events and diseases. To collect information regarding symptoms and potential trigger factors, such as perceived stress, a structured diary was constructed. The participants were instructed to fill in the diary daily during six months. Fifty patients completed the study. Results The analysis showed an effect for high level of perceived stress. Being exposed to “quite a lot” of stress, yield an increase in risk for relapse during the forthcoming day (OR = 4.8, 95% CI 1.09 - 21.10). No statistically increased risk for lower levels of perceived stress was found, although elevated effect estimates were found for “some” stress. Conclusion This study supports earlier findings regarding perceived stress as an important factor in triggering relapses in IBD. However, this is the first case-crossover study performed to explore the trigger risk of stress in this population. Further investigations with larger patient samples are needed to confirm the findings. PMID:27785220

  18. Studying the thermal/non-thermal crossover in solar flares

    NASA Technical Reports Server (NTRS)

    Schwartz, R. A.

    1994-01-01

    This report describes work performed under contract NAS5-32584 for Phase 3 of the Compton Gamma Ray Observatory (CGRO) from 1 November 1993 through 1 November 1994. We have made spectral observations of the hard x-ray and gamma-ray bremsstrahlung emissions from solar flares using the Burst and Transit Source Experiment (BASTE) on CGRO. These measurements of their spectrum and time profile provided valuable information on the fundamental flare processes of energy release, particle acceleration, and energy transport. Our scientific objective was to study both the thermal and non-thermal sources of solar flare hard x-ray and gamma-ray emission.

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

    NASA Astrophysics Data System (ADS)

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

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

  20. Masturbation prohibition in sex offenders: a crossover study.

    PubMed

    Brown, C M; Traverso, G; Fedoroff, J P

    1996-08-01

    Some self-help groups for individuals with aberrant sexual interests (e.g., Sexaholics Anonymous and Sex and Love Addicts Anonymous) maintain that a period of "sexual sobriety" is necessary for treatment. The hypothesis was tested that sexual urges during a 30-day period of voluntary abstinence from masturbation would be less frequent and intense than during a period when masturbation was not avoided. Outpatient pedophiles were randomly assigned to either refrain from masturbating or make no attempt to alter their masturbation frequency for a period of 30 days. All participants were crossed over to the other treatment condition at the start of the 2nd month. Sexual urges and behavior were measured using weekly self-reports. A repeated measures ANOVA failed to show a difference in reported intensity of sexual urges, F(7, 91) = 1.15, p = 0.34; masturbation urges, F(7, 91) = 1.73, p = 0.11; adult sex urges, F(7, 91) = 1.82, p = 0.09; or child sex urges, F(7, 91) = 1.58, p = 0.15, in Masturbation Allowed vs. Masturbation Not Allowed conditions. Of 17 participants, 3 (18%) were able to retain completely from masturbating for 1 month, 4 participants (25%) thought it was helpful not to masturbate; 1 participant (7%) thought therapists should recommend avoidance of masturbation. This study suggests that sexual sobriety from masturbation does not aid in the control of pedophilic fantasies. This may be because the technique is ineffective, or because so few participants are willing to engage in it.

  1. The black/white mortality crossover: investigation in a community-based study.

    PubMed

    Wing, S; Manton, K G; Stallard, E; Hames, C G; Tryoler, H A

    1985-01-01

    The black/white mortality crossover at about age 75, a result of lower white mortality rates at younger ages and lower black rates at the oldest ages, has been observed in U.S. vital statistics since 1900. Though a persistant observation in such data, its validity has been challenged by questions about census enumeration and age reporting on death certificates. Analyses of 20 years experience of all-cause mortality in the community-based Evans County Study using a Weibull model of age specific mortality rates showed a statistically significant black/white mortality crossover for both men (at age 73) and women (at age 85). The finding of a crossover in this longitudinally followed population is significant because the age reporting for both survivors and age at death for nonsurvivors were obtained in the study protocol and did not rely on age reporting either in census data or on the death certificate. Differences in the age and sex patterns of mortality between two populations living in the same geographic region are relevant to questions about the etiology of the major age-related chronic diseases as well as to topics of current interest in health care policy.

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

    PubMed

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

    2016-02-01

    Feasibly implemented Web-based smoking media literacy (SML) programs have been associated with improving SML skills among adolescents. However, prior evaluations have generally had weak experimental designs. We aimed to examine program efficacy using a more rigorous crossover design. Seventy-two ninth grade students completed a Web-based SML program based on health behavior theory and implemented using a two-group two-period crossover design. Students were randomly assigned by classroom to receive media literacy or control interventions in different sequences. They were assessed three times, at baseline (T0), an initial follow-up after the first intervention (T1) and a second follow-up after the second intervention (T2). Crossover analysis using analysis of variance demonstrated significant intervention coefficients, indicating that the SML condition was superior to control for the primary outcome of total SML (F = 11.99; P < 0.001) and for seven of the nine individual SML items. Results were consistent in sensitivity analyses conducted using non-parametric methods. There were changes in some exploratory theory-based outcomes including attitudes and normative beliefs but not others. In conclusion, while strength of the design of this study supports and extends prior findings around effectiveness of SML programs, influences on theory-based mediators of smoking should be further explored. PMID:26675176

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

    PubMed

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

    2016-02-01

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

  4. An exercise program to prevent falls in institutionalized elderly with cognitive deficits: a crossover pilot study.

    PubMed

    DeSure, Ariell R; Peterson, Karen; Gianan, Faith V; Pang, Lorrin

    2013-11-01

    Falls are the leading cause of injury among older adults in the United States, with the institutionalized elderly at elevated risk for injury and death. Physical weakness and mental frailty, prevalent in institutionalized elderly, are major risk factors for falls. The purpose of this study was to evaluate a program that addresses both the physical and mental aspects of exercise to reduce falls in institutionalized elderly. Twenty-seven volunteer subjects residing in an assisted living facility participated in the 24 week randomized crossover study. After demographic, fall history, and mental status examinations, subjects were randomly assigned first to ten weeks of either an exercise class or a control group, followed by a four week "washout period" of no activity, then cross assigned to ten weeks as either a control group or exercise class, respectively. Falls as well as mental status changes were monitored during the study. After adjusting for differences in baseline risk between the control and treatment groups, and for potential residual effects of the treatment during the crossover phase, a statistically significant (P = .025) reduction in falls was found during treatment compared to the control periods. No change in mental status was seen. This small, pilot study shows that exercise programs, which emphasize mental strengthening as well as physical fitness, have the potential to reduce falls among mentally impaired, institutionalized seniors.

  5. Daily dosing prophylaxis for haemophilia: a randomized crossover pilot study evaluating feasibility and efficacy.

    PubMed

    Lindvall, K; Astermark, J; Björkman, S; Ljung, R; Carlsson, K S; Persson, S; Berntorp, E

    2012-11-01

    Regular replacement therapy (prophylaxis) for haemophilia has been shown to prevent development of disabling arthropathy and to provide a better quality of life compared to treatment on demand; however, at a substantially higher cost. Calculations based on pharmacokinetic principles have shown that shortening dose intervals may reduce cost. The aim of this prospective, randomized, crossover pilot study was to address whether daily dosing is feasible, if it reduces concentrate consumption and is as effective in preventing bleeding as the standard prophylactic dosing regimen. In a 12+12 month crossover study, 13 patients were randomized to start either their own previously prescribed standard dose, or daily dosing adjusted to maintain at least the same trough levels as obtained with the standard dose. Ten patients completed the study. A 30% reduction in cost of factor concentrates was achieved with daily prophylaxis. However, the number of bleeding events increased in some patients in the daily dosing arm and patients reported decreased quality of life during daily prophylaxis. Daily treatment had a greater impact on daily life, and the patients found it more stressful.Prophylaxis with daily dosing may be feasible and efficacious in some patients. A substantial reduction of factor consumption and costs can be realized, but larger studies are needed before the introduction of daily prophylaxis into clinical routine can be recommended.

  6. The antiplaque efficacy of propolis-based herbal toothpaste: A crossover clinical study

    PubMed Central

    Bhat, Nagesh; Bapat, Salil; Asawa, Kailash; Tak, Mridula; Chaturvedi, Pulkit; Gupta, Vivek V.; George, Pradeep P.

    2015-01-01

    Background: In recent years, herbal products have been suggested as an economic, safe and probably effective alternative for prevention and control of various oral diseases. But still there are some products which need to be evaluated. Of lately, Propolis is one such product. To assess and compare the efficacy of herbal dentifrice containing Propolis with Miswak and Colgate total toothpastes in controlling plaque formation. Materials and Methods: A double blind, randomized, crossover study design was conducted among thirty healthy dental students. After oral prophylaxis all subjects were given a washout product for one week period. Subjects were then made to brush with (washout product) for 1 minute followed by 1 minute brushing with assigned test product. The baseline MGMPI plaque scores were recorded. Subjects were then refrained from oral hygiene for 24 hours, and were recalled to be re-disclosed and re-measured for plaque formation. This procedure was repeated according to crossover design after a washout period of (2 week). Statistical tests used were Krukalwallis and Wilcoxon sign rank test. Results: There was a significant difference in 24 hour score between the test products evaluated. When the change from baseline to 24 hours was analyzed, the test product Propolis resulted in a consistently and significantly (p < 0.05) lower MGMPI mean scores than the Colgate Total and Miswak toothpastes. Conclusion: Propolis was found to be safe and effective in reducing plaque accumulation when compared to Miswak and Colgate total toothpaste. PMID:26283831

  7. Aspartame and dizziness: preliminary results of a prospective, nonblinded, prevalence and attempted cross-over study.

    PubMed

    Gulya, A J; Sessions, R B; Troost, T R

    1992-09-01

    Aspartame is a low-calorie food sweetener recently approved by the FDA for general human consumption. One of us (AJG) treated a patient whose symptoms of episodic vertigo and continuous unsteadiness resolved upon ceasing aspartame intake. A literature review revealed that although dizziness has been associated with aspartame intake, no systematic study of the problem exists. As an initial attempt to ascertain the prevalence of aspartame-related dizziness in an otolaryngologic clinic, we elected to study prospectively all patients entering with the complaint of vertigo by means of a standardized questionnaire. Those patients determined to consume aspartame were further studied in a nonblinded manner to see if aspartame intake could be correlated to symptomatology. A cross-over limb was also attempted, but no patient would participate. This presentation details the case history of the propositus patient and the preliminary results of the currently ongoing prospective study.

  8. Apparent temperature and acute myocardial infarction hospital admissions in Copenhagen, Denmark: a case-crossover study

    PubMed Central

    2012-01-01

    Background The influence of temperature on acute myocardial infarction (AMI) has not been investigated as extensively as the effects of broader outcomes of morbidity and mortality. Sixteen studies reported inconsistent results and two considered confounding by air pollution. We addressed some of the methodological limitations of the previous studies in this study. Methods This is the first study of the association between the daily 3-hour maximum apparent temperature (Tappmax) and AMI hospital admissions in Copenhagen. The study period covered 1 January 1999-31 December 2006, stratified in warm (April - September) and cold (October - March) periods. A case-crossover epidemiology study design was applied. Models were adjusted for public holidays and influenza, confounding by PM10, NO2 and CO was investigated, the lag and non-linear effects of Tappmax was examined, effect modification by age, sex and SES was explored, and the results of the case-crossover models were compared to those of the generalised additive Poisson time-series and generalised estimating equation models. Results 14 456 AMI hospital admissions (12 995 people) occurred during the study period. For an inter-quartile range (6 or 7°C) increase in the 5-day cumulative average of Tappmax, a 4% (95% CI:-2%; 10%) and 9% (95% CI: 3%; 14%) decrease in the AMI admission rate was observed in the warm and cold periods, respectively. The 19-65 year old group, men and highest SES group seemed to be more susceptible in the cold period. Conclusion An increase in Tappmax is associated with a decrease in AMI admissions during the colder months. PMID:22463704

  9. Proton pump inhibitors and vascular function: A prospective cross-over pilot study

    PubMed Central

    Ghebremariam, Yohannes T.; Cooke, John P.; Khan, Fouzia; Thakker, Rahul N.; Chang, Peter; Shah, Nigam H.; Nead, Kevin T.; Leeper, Nicholas J.

    2015-01-01

    Background Proton pump inhibitors (PPIs) are commonly used drugs for the treatment of gastric reflux. Recent retrospective cohorts and large database studies have raised concern that the use of PPIs is associated with increased cardiovascular (CV) risk. However, there is no prospective clinical study evaluating whether the use of PPIs directly causes CV harm. Methods We conducted a controlled open-label cross-over pilot study among 21 adults aged 18 and older who are healthy (n = 11) or have established clinical cardiovascular disease (n = 10). Study subjects were assigned to receive a PPI (Prevacid; 30 mg) or a placebo pill once daily for 4 weeks. After a 2 week washout period, participants were crossed-over to receive the alternate treatment for the ensuing 4 weeks. Subjects underwent evaluation of vascular function (by the EndoPAT technique) and had plasma levels of asymmetric dimethylarginine (ADMA, an endogenous inhibitor of endothelial function previously implicated in PPI-mediated risk) measured prior to and after each treatment interval. Results We observed a marginal inverse correlation between the EndoPAT score and plasma levels of ADMA (r = −0.364). Subjects experienced a greater worsening in plasma ADMA levels while on PPI than on placebo, and this trend was more pronounced amongst those subjects with a history of vascular disease. However, these trends did not reach statistical significance, and PPI use was also not associated with an impairment in flow mediated vasodilation during the course of this study. Conclusions In this open-label, cross-over pilot study conducted among healthy subjects and coronary disease patients, PPI use did not significantly influence vascular endothelial function. Larger, long-term and blinded trials are needed to mechanistically explain the correlation between PPI use and adverse clinical outcomes, which has recently been reported in retrospective cohort studies. PMID:25835348

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

    SciTech Connect

    Galle, G.; Degert, J.; Freysz, E.; Etrillard, C.; Letard, J.-F.; Guillaume, F.

    2013-02-11

    We have studied the low spin to high spin phase transition induced by nanosecond laser pulses outside and within the thermal hysteresis loop of the [Fe(Htrz){sub 2} trz](BF{sub 4}){sub 2}-H{sub 2}O spin crossover nanoparticles. We demonstrate that, whatever the temperature of the compound, the photo-switching is achieved in less than 12.5 ns. Outside the hysteresis loop, the photo-induced high spin state remains up to 100 {mu}s and then relaxes. Within the thermal hysteresis loop, the photo-induced high spin state remains as long as the temperature of the sample is kept within the thermal loop. A Raman study indicates that the photo-switching can be completed using single laser pulse excitation.

  11. Air Pollution and Emergency Department Visits for Depression: A Multicity Case-Crossover Study

    PubMed Central

    Szyszkowicz, Mieczysław; Kousha, Termeh; Kingsbury, Mila; Colman, Ian

    2016-01-01

    BACKGROUND The aim of this study was to investigate the associations between ambient air pollution and emergency department (ED) visits for depression. METHODS Health data were retrieved from the National Ambulatory Care Reporting System. ED visits for depression were retrieved from the National Ambulatory Care Reporting System using the International Classification of Diseases (ICD-10), Tenth revision codes; ICD-10: F32 (mild depressive episode) and ICD-10: F33 (recurrent depressive disorder). A case-crossover design was employed for this study. Conditional logistic regression models were used to estimate odds ratios. RESULTS For females, exposure to ozone was associated with increased risk of an ED visit for depression between 1 and 7 days after exposure, for males, between 1 and 5, and 8 days after exposure, with odds ratios ranging between 1.02 and 1.03. CONCLUSIONS These findings suggest that, as hypothesized, there is a positive association between exposure to air pollution and ED visits for depression.

  12. Crossover Control Study of the Effect of Personal Care Products Containing Triclosan on the Microbiome.

    PubMed

    Poole, Angela C; Pischel, Lauren; Ley, Catherine; Suh, Gina; Goodrich, Julia K; Haggerty, Thomas D; Ley, Ruth E; Parsonnet, Julie

    2016-01-01

    Commonly prescribed antibiotics are known to alter human microbiota. We hypothesized that triclosan and triclocarban, components of many household and personal care products (HPCPs), may alter the oral and gut microbiota, with potential consequences for metabolic function and weight. In a double-blind, randomized, crossover study, participants were given triclosan- and triclocarban (TCS)-containing or non-triclosan/triclocarban (nTCS)-containing HPCPs for 4 months and then switched to the other products for an additional 4 months. Blood, stool, gingival plaque, and urine samples and weight data were obtained at baseline and at regular intervals throughout the study period. Blood samples were analyzed for metabolic and endocrine markers and urine samples for triclosan. The microbiome in stool and oral samples was then analyzed. Although there was a significant difference in the amount of triclosan in the urine between the TCS and nTCS phases, no differences were found in microbiome composition, metabolic or endocrine markers, or weight. Though this study was limited by the small sample size and imprecise administration of HPCPs, triclosan at physiologic levels from exposure to HPCPs does not appear to have a significant or important impact on human oral or gut microbiome structure or on a panel of metabolic markers. IMPORTANCE Triclosan and triclocarban are commonly used commercial microbicides found in toothpastes and soaps. It is unknown what effects these chemicals have on the human microbiome or on endocrine function. From this randomized crossover study, it appears that routine personal care use of triclosan and triclocarban neither exerts a major influence on microbial communities in the gut and mouth nor alters markers of endocrine function in humans. PMID:27303746

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

    PubMed

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

    2016-04-01

    Following a chemical, biological, radiation, and nuclear incident, prompt cardiopulmonary resuscitation (CPR) procedure is essential for patients who suffer cardiac arrest. But CPR when wearing personal protection equipment (PPE) before decontamination becomes a challenge for healthcare workers (HCW). Although previous studies have assessed the impact of PPE on airway management, there is little research available regarding the quality of chest compression (CC) when wearing PPE.A present randomized cross-over simulation study was designed to evaluate the effect of PPE on CC performance using mannequins.The study was set in one university medical center in the China.Forty anesthesia residents participated in this randomized cross-over study.Each participant performed 2 min of CC on a manikin with and without PPE, respectively. Participants were randomized into 2 groups that either performed CC with PPE first, followed by a trial without PPE after a 180-min rest, or vice versa.CPR recording technology was used to objectively quantify the quality of CC. Additionally, participants' physiological parameters and subjective fatigue score values were recorded.With the use of PPE, a significant decrease of the percentage of effective compressions (41.3 ± 17.1% with PPE vs 67.5 ± 15.6% without PPE, P < 0.001) and the percentage of adequate compressions (67.7 ± 18.9% with PPE vs 80.7 ± 15.5% without PPE, P < 0.001) were observed. Furthermore, the increases in heart rate, mean arterial pressure, and subjective fatigue score values were more obvious with the use of PPE (all P < 0.01).We found significant deterioration of CC performance in HCW with the use of a level-C PPE, which may be a disadvantage for enhancing survival of cardiac arrest. PMID:27057878

  14. Crossover Control Study of the Effect of Personal Care Products Containing Triclosan on the Microbiome.

    PubMed

    Poole, Angela C; Pischel, Lauren; Ley, Catherine; Suh, Gina; Goodrich, Julia K; Haggerty, Thomas D; Ley, Ruth E; Parsonnet, Julie

    2016-01-01

    Commonly prescribed antibiotics are known to alter human microbiota. We hypothesized that triclosan and triclocarban, components of many household and personal care products (HPCPs), may alter the oral and gut microbiota, with potential consequences for metabolic function and weight. In a double-blind, randomized, crossover study, participants were given triclosan- and triclocarban (TCS)-containing or non-triclosan/triclocarban (nTCS)-containing HPCPs for 4 months and then switched to the other products for an additional 4 months. Blood, stool, gingival plaque, and urine samples and weight data were obtained at baseline and at regular intervals throughout the study period. Blood samples were analyzed for metabolic and endocrine markers and urine samples for triclosan. The microbiome in stool and oral samples was then analyzed. Although there was a significant difference in the amount of triclosan in the urine between the TCS and nTCS phases, no differences were found in microbiome composition, metabolic or endocrine markers, or weight. Though this study was limited by the small sample size and imprecise administration of HPCPs, triclosan at physiologic levels from exposure to HPCPs does not appear to have a significant or important impact on human oral or gut microbiome structure or on a panel of metabolic markers. IMPORTANCE Triclosan and triclocarban are commonly used commercial microbicides found in toothpastes and soaps. It is unknown what effects these chemicals have on the human microbiome or on endocrine function. From this randomized crossover study, it appears that routine personal care use of triclosan and triclocarban neither exerts a major influence on microbial communities in the gut and mouth nor alters markers of endocrine function in humans.

  15. Crossover Control Study of the Effect of Personal Care Products Containing Triclosan on the Microbiome

    PubMed Central

    Poole, Angela C.; Pischel, Lauren; Ley, Catherine; Suh, Gina; Goodrich, Julia K.; Haggerty, Thomas D.; Ley, Ruth E.

    2016-01-01

    ABSTRACT Commonly prescribed antibiotics are known to alter human microbiota. We hypothesized that triclosan and triclocarban, components of many household and personal care products (HPCPs), may alter the oral and gut microbiota, with potential consequences for metabolic function and weight. In a double-blind, randomized, crossover study, participants were given triclosan- and triclocarban (TCS)-containing or non-triclosan/triclocarban (nTCS)-containing HPCPs for 4 months and then switched to the other products for an additional 4 months. Blood, stool, gingival plaque, and urine samples and weight data were obtained at baseline and at regular intervals throughout the study period. Blood samples were analyzed for metabolic and endocrine markers and urine samples for triclosan. The microbiome in stool and oral samples was then analyzed. Although there was a significant difference in the amount of triclosan in the urine between the TCS and nTCS phases, no differences were found in microbiome composition, metabolic or endocrine markers, or weight. Though this study was limited by the small sample size and imprecise administration of HPCPs, triclosan at physiologic levels from exposure to HPCPs does not appear to have a significant or important impact on human oral or gut microbiome structure or on a panel of metabolic markers. IMPORTANCE Triclosan and triclocarban are commonly used commercial microbicides found in toothpastes and soaps. It is unknown what effects these chemicals have on the human microbiome or on endocrine function. From this randomized crossover study, it appears that routine personal care use of triclosan and triclocarban neither exerts a major influence on microbial communities in the gut and mouth nor alters markers of endocrine function in humans. PMID:27303746

  16. Effect of Sensory Stimuli on Restless Legs Syndrome: A Randomized Crossover Study

    PubMed Central

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

    2014-01-01

    Study Objective: A variety of sensory stimuli relieve restless legs syndrome symptoms. Because systematic evaluations of sensory stimulation in restless legs syndrome are largely lacking, we performed a randomized crossover study to evaluate the effect of external sensory stimulation on restless legs syndrome symptoms. Methods: Eighteen patients underwent 3 consecutive suggestive immobilization tests with the order of the following 3 conditions randomly assigned: no electrical stimulation (condition 1), tactile and proprioceptive sensory stimulation (condition 2), and tactile sensory stimulation only (condition 3). Restless legs syndrome symptoms were quantified by visual analog scales, and periodic leg movements during wake were measured. Results: Baseline visual analogue scale score was 4.5 (range 0-60) in condition 1, 10.5 (range 0-96) in condition 2, and 8.5 in condition 3 (p = 0.21). There was a tendency towards a higher maximum visual analogue scale score and visual analogue scale score at the end of the suggested immobilization test in the conditions with tactile sensory stimulation, though not significant (p = 0.74 and p = 0.29, respectively). Fifteen patients suffered from periodic leg movements during wake. Median indices were 18 (range 0-145) in condition 1, 26 (range 0-190) in condition 2, and 49 (range 0-228) in condition 3 (p = 0.76). Conclusions: We found a tendency towards less leg discomfort in the conditions in which an external sensory input was applied. This potential benefit of sensory stimuli on restless legs syndrome severity merits further investigation as this could open new ways towards a better pathophysiological understanding and non-pharmacological treatments. Citation: Rozeman AD, Ottolini T, Grootendorst DC, Vogels OJM, Rijsman RM. Effect of sensory stimuli on restless legs syndrome: a randomized crossover study. J Clin Sleep Med 2014;10(8):893-896. PMID:25126036

  17. Randomised, double blind, crossover challenge study of allergenicity of peanut oils in subjects allergic to peanuts.

    PubMed Central

    Hourihane, J. O.; Bedwani, S. J.; Dean, T. P.; Warner, J. O.

    1997-01-01

    OBJECTIVE: To determine the in vivo allergenicity of two grades of peanut oil for a large group of subjects with proved allergy to peanuts. DESIGN: Double blind, crossover food challenge with crude peanut oil and refined peanut oil. SETTING: Dedicated clinical investigation unit in a university hospital. SUBJECTS: 60 subjects allergic to peanuts; allergy was confirmed by challenge tests. OUTCOME MEASURES: Allergic reaction to the tested peanut oils. RESULTS: None of the 60 subjects reacted to the refined oil; six (10%) reacted to the crude oil. Supervised peanut challenge caused considerably less severe reactions than subjects had reported previously. CONCLUSIONS: Crude peanut oil caused allergic reactions in 10% of allergic subjects studied and should continue to be avoided. Refined peanut oil did not pose a risk to any of the subjects. It would be reasonable to recommend a change in labelling to distinguish refined from crude peanut oil. PMID:9133891

  18. Effectiveness of Mentha piperita in the Treatment of Infantile Colic: A Crossover Study.

    PubMed

    Alves, João Guilherme Bezerra; de Brito, Rita de Cássia Coelho Moraes; Cavalcanti, Telma Samila

    2012-01-01

    Background. Infantile colic is a distressing and common condition for which there is no proven standard treatment. Objective. To compare the efficacy of Mentha piperita with simethicone in treatment for infantile colic. Methods. A double-blind crossover study was performed with 30 infants attending IMIP, Recife, Brazil. They were randomized to use Mentha piperita or simethicone in the treatment of infantile colic during 7 days with each drug. Primary outcomes were mother_s opinion about responses to the treatment, number of daily episodes of colic, and time spent crying, measured by a chronometer. Mann-Whitney and chi-square tests were used to compare the results. This study was previously approved by the Ethical Committee in Research at IMIP. Results. At baseline daily episodes of infantile colic was 3.9 (±1.1) and the mean crying time per day was 192 minutes (±51.6). At the end of the study daily episodes of colic fell to 1.6 (±0.6) and the crying duration decreased to 111 (±28) minutes. All mothers reported decrease of frequency and duration of the episodes of infantile colic and there were no differences between responses to Mentha piperita and simethicone. Conclusions. These findings suggest that Mentha piperita may be used to help control infantile colic. However, these results must be repeated by others studies.

  19. Synthetic food colourings and 'hyperactivity': a double-blind crossover study.

    PubMed

    Rowe, K S

    1988-04-01

    Of 220 children referred for suspected 'hyperactivity', 55 were subjected to a 6 week trial of the Feingold diet. Forty (72.7%) demonstrated improved behaviour and 26 (47.3%) remained improved following liberalization of the diet over a period of 3-6 months. The parents of 14 children claimed that a particular cluster of behaviours was associated with the ingestion of foods containing synthetic colourings. A double-blind crossover study, employing a single-subject repeated measures design was conducted, using eight of these children. Subjects were maintained on a diet free from synthetic additives and were challenged daily for 18 weeks with either placebo (during lead-in and washout periods) or 50 mg of either tartrazine or carmoisine, each for 2 separate weeks. Two significant reactors were identified whose behavioural pattern featured extreme irritability, restlessness and sleep disturbance. One of the reactors did not have inattention as a feature. The findings raise the issue of whether the strict criteria for inclusion in studies concerned with 'hyperactivity' based on 'attention deficit disorder' may miss children who indicate behavioural changes associated with the ingestion of food colourings. Moreover, for further studies, the need to construct a behavioural rating instrument specifically validated for dye challenge is suggested.

  20. TD-DFT study of the light-induced spin crossover of Fe(III) complexes.

    PubMed

    Saureu, Sergi; de Graaf, Coen

    2016-01-14

    Two light-induced spin-crossover Fe(III) compounds have been studied with time-dependent density functional theory (TD-DFT) to investigate the deactivation mechanism and the role of the ligand-field states as intermediates in this process. The B3LYP* functional has previously shown its ability to accurately describe (light-induced) spin-crossover in Fe(II) complexes. Here, we establish its performance for Fe(III) systems using [Fe(qsal)2](+) (Hqsal = 2-[(8-quinolinylimino)methyl]phenol) and [Fe(pap)2](+) (Hpap = 2-(2-pyridylmethyleneamino)phenol) as test cases comparing the B3LYP* results to experimental information and to multiconfigurational wave function results. In addition to rather accurate high spin (HS) and low spin (LS) state geometries, B3LYP* also predicts ligand-to-metal charge transfer (LMCT) states with large oscillator strength in the energy range where the UV-VIS spectrum shows an intense absorption band, whereas optically allowed π-π* excitations on the ligands were calculated at higher energy. Subsequently, we have generated a two-dimensional potential energy surface of the HS and LS states varying the Fe-N and Fe-O distances. LMCT and metal centered (MC) excited states were followed along the approximate minimal energy path that connects the minima of the HS and LS on this surface. The (2)LMCT state has a minimum in the same region as the initial LS state, where we also observe a crossing with the intermediate spin (IS) state. Upon the expansion of the coordination sphere of the Fe(III) ion, the IS state crosses with the HS state and further expansion of the coordination sphere leads to the excited spin state trapping as observed in experiment. The calculation of the intersystem crossing rates reveals that the deactivation from (2)LMCT → IS → HS competes with the (2)LMCT → IS → LS pathway, in line with the low efficiency encountered in experiments. PMID:26660866

  1. First principles study of thermal conductivity cross-over in nanostructured zinc-chalcogenides

    SciTech Connect

    Katre, Ankita; Madsen, Georg K. H.; Togo, Atsushi; Tanaka, Isao

    2015-01-28

    Systematic first principles studies of zinc-chalcogenides have been performed to understand their thermal transport behaviour. We have applied the Boltzmann transport equation in the relaxation time approximation to calculate the thermal conductivity of ZnS, ZnSe, and ZnTe. We find a thermal conductivity cross-over between ZnS and ZnSe at nanostructure sizes around 0.1–0.2 μm and explain this in terms of the different contributions of phonon modes in these materials. We study the effect of nanostructuring using both the diffusive boundary scattering and confined mean free path limit and discuss the variations in the results. Furthermore, we show the strong influence of isotope scattering on the thermal conductivity. The calculated thermal conductivity is found to be strongly dependent on the volume and we explain the observed differences between local density and generalized gradient approximation calculations. We compare further calculated thermal properties, such as the thermal expansion coefficient, to experiment to validate our approach.

  2. Air Pollution and Emergency Department Visits for Depression: A Multicity Case-Crossover Study

    PubMed Central

    Szyszkowicz, Mieczysław; Kousha, Termeh; Kingsbury, Mila; Colman, Ian

    2016-01-01

    BACKGROUND The aim of this study was to investigate the associations between ambient air pollution and emergency department (ED) visits for depression. METHODS Health data were retrieved from the National Ambulatory Care Reporting System. ED visits for depression were retrieved from the National Ambulatory Care Reporting System using the International Classification of Diseases (ICD-10), Tenth revision codes; ICD-10: F32 (mild depressive episode) and ICD-10: F33 (recurrent depressive disorder). A case-crossover design was employed for this study. Conditional logistic regression models were used to estimate odds ratios. RESULTS For females, exposure to ozone was associated with increased risk of an ED visit for depression between 1 and 7 days after exposure, for males, between 1 and 5, and 8 days after exposure, with odds ratios ranging between 1.02 and 1.03. CONCLUSIONS These findings suggest that, as hypothesized, there is a positive association between exposure to air pollution and ED visits for depression. PMID:27597809

  3. Can patients identify what triggers their back pain? Secondary analysis of a case-crossover study.

    PubMed

    Parreira, Patricia do Carmo Silva; Maher, Chris G; Latimer, Jane; Steffens, Daniel; Blyth, Fiona; Li, Qiang; Ferreira, Manuela L

    2015-10-01

    The aim of this case-crossover study was to investigate the extent to which patients can accurately nominate what triggered their new episode of sudden-onset acute low back pain (LBP). We interviewed 999 primary care patients to record exposure to 12 standard triggers and also asked the patients to nominate what they believed triggered their LBP. Exposure to the patient-nominated trigger during the case window was compared with exposure in the control window. Conditional logistic regression models were constructed to quantify the risk of LBP onset associated with the patient-nominated trigger. Sensitivity analyses were conducted varying the duration and timing of case/control windows. We compared the extent to which patient-nominated triggers matched standard triggers. The odds ratios for exposure to patient-nominated triggers ranged from 8.60 to 30.00, suggesting that exposure increases the risk of LBP. Patients' understanding of triggers however seems incomplete, as we found evidence that while some of the standard triggers were well recognised (such as lifting heavy loads), others (such as being distracted during manual tasks) were under-recognised as possible triggers of an episode of LBP. This study provides some evidence that patients can accurately nominate the activity that triggered their new episode of sudden-onset acute LBP. PMID:26039901

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

    PubMed Central

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

    2016-01-01

    Only 30 percent of chronic diabetic foot ulcers heal after 20 weeks of standard treatment. Pirfenidone is a drug with biological, anti-inflammatory, and antifibrotic effects. The aim of this study was to evaluate the effect of topical pirfenidone added to conventional treatment in noninfected chronic diabetic foot ulcers. This was a randomized crossover study. Group 1 received topical pirfenidone plus conventional treatment for 8 weeks; after this period, they were switched to receive conventional treatment only for 8 more weeks. In group 2, the order of the treatments was the opposite. The end points were complete ulcer healing and size reduction. Final data were obtained from 35 ulcers in 24 patients. Fifty-two percent of ulcers treated with pirfenidone healed before 8 weeks versus 14.3% treated with conventional treatment only (P = 0.025). Between 8 and 16 weeks, 30.8% ulcers that received pirfenidone healed versus 0% with conventional treatment (P = 0.081). By week 8, the reduction in ulcer size was 100% [73–100] with pirfenidone versus 57.5% with conventional treatment [28.9–74] (P = 0.011). By week 16, the reduction was 93% [42.7–100] with pirfenidone and 21.8% [8–77.5] with conventional treatment (P = 0.050). The addition of topical pirfenidone to conventional treatment significantly improves the healing of chronic diabetic noninfected foot ulcers. PMID:27478849

  5. Alcohol Abuse and Suicide Attempt in Iran: A Case-Crossover Study

    PubMed Central

    Ghanbari, Behrooz; Malakouti, Seyed Kazem; Nojomi, Marzieh; Leo, Diego De; Saeed, Khalid

    2016-01-01

    Alcohol use and its disorders are associated with increased risk of suicidal behaviors Research has shown that 6-8% of those who use alcohol have a history of suicide attempt. Given the prohibition of alcohol use legally, the increased alcohol consumption, and the lack of strong evidence in favor of its use associated with suicide in Iran, this study was conducted to determine the link between suicide attempt and alcohol abuse. The case-crossover method was used in this research. Out of 305 referrals to the emergency room due to a suicide attempt, 100 reported drinking alcohol up to six hours before their attempt. Paired Matching and Usual Frequency were employed to analyze the data with STATA 12.0. The probability of attempting suicide up to six hours after drinking alcohol appeared increased by 27 times (95% CI: 8.1-60.4). Separate analysis for each of these hours from the first to the sixth hour after alcohol use was also performed. Fifty percent of attempted suicides happened one hour after alcohol use. Relative risk for the first and second hour was 10% and 5% respectively. Alcohol use is a strong proximal risk factor for attempted suicide among Iranian subjects. Prevention of alcohol use should be considered in setting up of the national Suicide attempt prevention program. PMID:26925903

  6. Effect of Exercise Intensity on Spontaneous Physical Activity Energy Expenditure in Overweight Boys: A Crossover Study

    PubMed Central

    Paravidino, Vitor Barreto; Mediano, Mauro Felippe Felix; Hoffman, Daniel J.; Sichieri, Rosely

    2016-01-01

    Objective Evaluate the effect of different exercise intensities on spontaneous physical activity energy expenditure in overweight adolescents. Methods A crossover study was developed with a control session, followed by moderate and vigorous exercise sessions, with six days of monitoring each. Twenty-four adolescents, 11–13 years old, male and overweight were selected. Spontaneous physical activity energy expenditure was assessed by accelerometers. Linear mixed effects models were used to evaluate the differences per session across time. Results Energy expenditure during the 1st hour was different between all three sessions, with averages of 82, 286 and 343 kcal to the control, moderate and vigorous sessions, respectively (p <0.001). The same pattern of difference in energy expenditure between the sessions remained after 24 hours (704 vs 970 vs 1056 kcal, p <0.001). However, energy expenditure during the six days indicates compensation from second to the sixth day, although small differences remained at the end of the 6-day period (5102 vs 5193 vs 5271 kcal, p <0.001). Conclusions A single aerobic session seems to modify the spontaneous physical activities in overweight adolescents but still keeping the vigorous session with higher total energy expenditure during the follow-up period. Despite the observed compensatory effect, the greater energy expenditure observed in both moderate and vigorous exercise sessions indicates that physical activity should be recommended to promote an increased energy expenditure in adolescents. Trial Registration ClinicalTrials.gov NCT 02272088 PMID:26771742

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

    NASA Technical Reports Server (NTRS)

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

    2000-01-01

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

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

    PubMed

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

    2016-01-14

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

  9. Visual Rehabilitation in Chronic Cerebral Blindness: A Randomized Controlled Crossover Study.

    PubMed

    Elshout, Joris A; van Asten, Freekje; Hoyng, Carel B; Bergsma, Douwe P; van den Berg, Albert V

    2016-01-01

    The treatment of patients suffering from cerebral blindness following stroke is a topic of much recent interest. Several types of treatment are under investigation, such as substitution with prisms and compensation training of saccades. A third approach, aimed at vision restitution is controversial, as a proper controlled study design is missing. In the current study, 27 chronic stroke patients with homonymous visual field defects were trained at home with a visual training device. We used a discrimination task for two types of stimuli: a static point stimulus and a new optic flow-discontinuity stimulus. Using a randomized controlled crossover design, each patient received two successive training rounds, one with high contrast stimuli in their affected hemifield (test) and one round with low-contrast stimuli in their intact hemifield (control). Goldmann and Humphrey perimetry were performed at the start of the study and following each training round. In addition, reading performance was measured. Goldmann perimetry revealed a statistically significant reduction of the visual field defect after the test training, but not after the control training or after no intervention. For both training rounds combined, Humphrey perimetry revealed that the effect of a directed training (sensitivity change in trained hemifield) exceeded that of an undirected training (sensitivity change in untrained hemifield). The interaction between trained and tested hemifield was just above the threshold of significance (p = 0.058). Interestingly, reduction of the field defect assessed by Goldmann perimetry increases with the difference between defect size as measured by Humphrey and Goldmann perimetry prior to training. Moreover, improvement of visual sensitivity measured by Humphrey perimetry increases with the fraction of non-responsive elements (i.e., more relative field loss) in Humphrey perimetry prior to training. Reading speed revealed a significant improvement after training. Our

  10. A Case-Crossover Study of Heat Exposure and Injury Risk in Outdoor Agricultural Workers

    PubMed Central

    Bonauto, David K.; Sheppard, Lianne; Busch-Isaksen, Tania; Calkins, Miriam; Adams, Darrin; Lieblich, Max; Fenske, Richard A.

    2016-01-01

    Background Recent research suggests that heat exposure may increase the risk of traumatic injuries. Published heat-related epidemiological studies have relied upon exposure data from individual weather stations. Objective To evaluate the association between heat exposure and traumatic injuries in outdoor agricultural workers exposed to ambient heat and internal heat generated by physical activity using modeled ambient exposure data. Methods A case-crossover study using time-stratified referent selection among 12,213 outdoor agricultural workers with new Washington State Fund workers’ compensation traumatic injury claims between 2000 and 2012 was conducted. Maximum daily Humidex exposures, derived from modeled meteorological data, were assigned to latitudes and longitudes of injury locations on injury and referent dates. Conditional logistic regression was used to estimate odds ratios of injury for a priori daily maximum Humidex categories. Results The mean of within-stratum (injury day and corresponding referent days) standard deviations of daily maximum Humidex was 4.8. The traumatic injury odds ratio was 1.14 (95% confidence interval 1.06, 1.22), 1.15 (95% confidence interval 1.06, 1.25), and 1.10 (95% confidence interval 1.01, 1.20) for daily maximum Humidex of 25–29, 30–33, and ≥34, respectively, compared to < 25, adjusted for self-reported duration of employment. Stronger associations were observed during cherry harvest duties in the June and July time period, compared to all duties over the entire study period. Conclusions Agricultural workers laboring in warm conditions are at risk for heat-related traumatic injuries. Combined heat-related illness and injury prevention efforts should be considered in high-risk populations exposed to warm ambient conditions in the setting of physical exertion. PMID:27716794

  11. Fluoxetine and premature ejaculation: a double-blind, crossover, placebo-controlled study.

    PubMed

    Haensel, S M; Klem, T M; Hop, W C; Slob, A K

    1998-02-01

    The purpose of this study was to investigate the effect of fluoxetine on sexual function in men with premature ejaculation and/or erectile dysfunction and control subjects in a prospective, double-blind, placebo-controlled, crossover study. There were four groups: (1) premature ejaculation (PE, N = 9); (2) premature ejaculation and erectile dysfunction (PE/ED, N = 9); (3) erectile dysfunction (ED, N = 7); and (4) healthy, sexually functional control subjects (N = 15). The study consisted of three 4-week periods: fluoxetine, washout, and placebo (or vice versa). Fluoxetine began at 5 mg/day for 2 weeks, followed by 10 mg/day for 2 weeks. At weeks 0, 4, 8, and 12, subjects visited the laboratory for evaluation of sexual function and assessment of erectile response, ejaculation, and sexual arousal to visual erotic stimulation without and with concomitant vibrotactile stimulation to the penis. At home, daily logs for sexual activities and feelings of well-being were maintained, and nocturnal penile tumescence was measured. The latency to ejaculation increased significantly in the PE/ED group (p = 0.03) and in the PE and the PE/ED group taken together (p = 0.007) but not in the PE group alone. Fluoxetine stimulated objectively but not subjectively measured erectile response during laboratory assessment in all groups. No major side effects were reported. In conclusion, fluoxetine (5-10 mg/day) was effective in increasing latency to ejaculation in patients with PE (PE and PE/ED groups combined). PMID:9472846

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

    PubMed

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

    2016-01-14

    Gluten is a crucial functional component of bread, but the effect of increasing gluten content on gastrointestinal (GI) function remains uncertain. Our aim was to investigate the effect of increasing gluten content on GI function and symptoms in healthy participants using the unique capabilities of MRI. A total of twelve healthy participants completed this randomised, mechanistic, open-label, three-way crossover study. On days 1 and 2 they consumed either gluten-free bread (GFB), or normal gluten content bread (NGCB) or added gluten content bread (AGCB). The same bread was consumed on day 3, and MRI scans were performed every 60 min from fasting baseline up to 360 min after eating. The appearance of the gastric chime in the images was assessed using a visual heterogeneity score. Gastric volumes, the small bowel water content (SBWC), colonic volumes and colonic gas content and GI symptoms were measured. Fasting transverse colonic volume after the 2-d preload was significantly higher after GFB compared with NGCB and AGCB with a dose-dependent response (289 (SEM 96) v. 212 (SEM 74) v. 179 (SEM 87) ml, respectively; P=0·02). The intragastric chyme heterogeneity score was higher for the bread with increased gluten (AGCB 6 (interquartile range (IQR) 0·5) compared with GFB 3 (IQR 0·5); P=0·003). However, gastric half-emptying time was not different between breads nor were study day GI symptoms, postprandial SBWC, colonic volume and gas content. This MRI study showed novel mechanistic insights in the GI responses to different breads, which are poorly understood notwithstanding the importance of this staple food. PMID:26522233

  13. Visual Rehabilitation in Chronic Cerebral Blindness: A Randomized Controlled Crossover Study

    PubMed Central

    Elshout, Joris A.; van Asten, Freekje; Hoyng, Carel B.; Bergsma, Douwe P.; van den Berg, Albert V.

    2016-01-01

    The treatment of patients suffering from cerebral blindness following stroke is a topic of much recent interest. Several types of treatment are under investigation, such as substitution with prisms and compensation training of saccades. A third approach, aimed at vision restitution is controversial, as a proper controlled study design is missing. In the current study, 27 chronic stroke patients with homonymous visual field defects were trained at home with a visual training device. We used a discrimination task for two types of stimuli: a static point stimulus and a new optic flow-discontinuity stimulus. Using a randomized controlled crossover design, each patient received two successive training rounds, one with high contrast stimuli in their affected hemifield (test) and one round with low-contrast stimuli in their intact hemifield (control). Goldmann and Humphrey perimetry were performed at the start of the study and following each training round. In addition, reading performance was measured. Goldmann perimetry revealed a statistically significant reduction of the visual field defect after the test training, but not after the control training or after no intervention. For both training rounds combined, Humphrey perimetry revealed that the effect of a directed training (sensitivity change in trained hemifield) exceeded that of an undirected training (sensitivity change in untrained hemifield). The interaction between trained and tested hemifield was just above the threshold of significance (p = 0.058). Interestingly, reduction of the field defect assessed by Goldmann perimetry increases with the difference between defect size as measured by Humphrey and Goldmann perimetry prior to training. Moreover, improvement of visual sensitivity measured by Humphrey perimetry increases with the fraction of non-responsive elements (i.e., more relative field loss) in Humphrey perimetry prior to training. Reading speed revealed a significant improvement after training. Our

  14. A randomised cross-over pharmacokinetic bioavailability study of synthetic versus kiwifruit-derived vitamin C.

    PubMed

    Carr, Anitra C; Bozonet, Stephanie M; Vissers, Margreet C M

    2013-11-11

    Kiwifruit are a rich source of vitamin C and also contain numerous phytochemicals, such as flavonoids, which may influence the bioavailability of kiwifruit-derived vitamin C. The aim of this study was to compare the relative bioavailability of synthetic versus kiwifruit-derived vitamin C using a randomised cross-over pharmacokinetic study design. Nine non-smoking males (aged 18-35 years) received either a chewable tablet (200 mg vitamin C) or the equivalent dose from gold kiwifruit (Actinidia chinensis var. Sungold). Fasting blood and urine were collected half hourly to hourly over the eight hours following intervention. The ascorbate content of the plasma and urine was determined using HPLC with electrochemical detection. Plasma ascorbate levels increased from 0.5 h after the intervention (P = 0.008). No significant differences in the plasma time-concentration curves were observed between the two interventions (P = 0.645). An estimate of the total increase in plasma ascorbate indicated complete uptake of the ingested vitamin C tablet and kiwifruit-derived vitamin C. There was an increase in urinary ascorbate excretion, relative to urinary creatinine, from two hours post intervention (P < 0.001). There was also a significant difference between the two interventions, with enhanced ascorbate excretion observed in the kiwifruit group (P = 0.016). Urinary excretion was calculated as ~40% and ~50% of the ingested dose from the vitamin C tablet and kiwifruit arms, respectively. Overall, our pharmacokinetic study has shown comparable relative bioavailability of kiwifruit-derived vitamin C and synthetic vitamin C.

  15. A Randomized Crossover Study of Web-Based Media Literacy to Prevent Smoking

    ERIC Educational Resources Information Center

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

    2016-01-01

    Feasibly implemented Web-based smoking media literacy (SML) programs have been associated with improving SML skills among adolescents. However, prior evaluations have generally had weak experimental designs. We aimed to examine program efficacy using a more rigorous crossover design. Seventy-two ninth grade students completed a Web-based SML…

  16. Distinct age and self-rated health crossover mortality effects for African Americans: Evidence from a national cohort study.

    PubMed

    Roth, David L; Skarupski, Kimberly A; Crews, Deidra C; Howard, Virginia J; Locher, Julie L

    2016-05-01

    The predictive effects of age and self-rated health (SRH) on all-cause mortality are known to differ across race and ethnic groups. African American adults have higher mortality rates than Whites at younger ages, but this mortality disparity diminishes with advancing age and may "crossover" at about 75-80 years of age, when African Americans may show lower mortality rates. This pattern of findings reflects a lower overall association between age and mortality for African Americans than for Whites, and health-related mechanisms are typically cited as the reason for this age-based crossover mortality effect. However, a lower association between poor SRH and mortality has also been found for African Americans than for Whites, and it is not known if the reduced age and SRH associations with mortality for African Americans reflect independent or overlapping mechanisms. This study examined these two mortality predictors simultaneously in a large epidemiological study of 12,181 African Americans and 17,436 Whites. Participants were 45 or more years of age when they enrolled in the national REasons for Geographic and Racial Differences in Stroke (REGARDS) study between 2003 and 2007. Consistent with previous studies, African Americans had poorer SRH than Whites even after adjusting for demographic and health history covariates. Survival analysis models indicated statistically significant and independent race*age, race*SRH, and age*SRH interaction effects on all-cause mortality over an average 9-year follow-up period. Advanced age and poorer SRH were both weaker mortality risk factors for African Americans than for Whites. These two effects were distinct and presumably tapped different causal mechanisms. This calls into question the health-related explanation for the age-based mortality crossover effect and suggests that other mechanisms, including behavioral, social, and cultural factors, should be considered in efforts to better understand the age-based mortality

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

    PubMed

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

    1982-01-01

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

  18. Double-blind crossover study of ranitidine and ebrotidine in gastro-esophageal reflux disease.

    PubMed

    Sito, E; Thor, P J; M[aczka, M; Lorens, K; Konturek, S J; Maj, A

    1993-09-01

    Gastroesophageal reflux disease (GERD) is multifactorial disorder in which acid exposure has a central role in the mucosal damage, and the mainstay of medical treatment is the suppression of gastric acid secretion justifying the use of H2 receptors antagonists. In our study we compared the effects of ranitidine and ebrotidine, a novel H2 antagonist with gastroprotective properties, on the motor, pH and endoscopic aspects of GERD in randomized cross-over trial in humans. Twenty patients with endoscopic evidence of erosive esophagitis were included in the study. Esophageal manometry and 24-hour pH-metry were done with the use Synectics (Sweden) systems. The same examinations were repeated after 20 days period of treatment with either ranitidine or ebrotidine, given in single dose 300 and 800 mg (nocte) respectively. The pressure within the lower esophageal sphincter (LES) in the untreated and treated with ebrotidine or ranitidine patients remained lowered. Patients with GERD showed increase in duration and decrease in amplitude and propagation of peristaltic waves in the esophageal body which were not improved after treatment. Complete healing after 40 days of treatment was comparable with ebrotidine and ranitidine and averaged about 40%. The pH-metry showed improvement in treated patients in the reflux frequency and time pH below 4, ranitidine being more effective than ebrotidine. It can be concluded that GERD patients showed weaker primary peristalsis unrelated to LES pressure and treatment. Treatment with ebrotidine or ranitidine reduced significantly the endoscopic and self-assessment score, ebrotidine and ranitidine being equally effective in healing of esophageal mucosal lesions.

  19. Rapid weather changes are associated with increased ischemic stroke risk: a case-crossover study.

    PubMed

    Rakers, Florian; Schiffner, Rene; Rupprecht, Sven; Brandstädt, Antje; Witte, Otto W; Walther, Mario; Schlattmann, Peter; Schwab, Matthias

    2016-02-01

    Observational studies focusing on absolute meteorological values suggest an association between meteorological parameters and stroke risk but these results are inconsistent and conflicting. Since changes in weather can provoke atrial fibrillation, we examined the association between rapid weather changes and stroke risk in 1694 patients with determinable onset of stroke symptoms in a case-crossover study in central Germany. Days one to three before stroke onset were classified as hazard periods and day seven as the respective control period. Risk of ischemic stroke in relation to 24 h differences in mean ambient temperature, relative humidity and atmospheric pressure was determined. The association between temperature and stroke risk appears to be close to linear with an increase in stroke risk of 11 % (odds ratio 1.11, 95 % confidence interval 1.01-1.22) for each 2.9 °C temperature decrease over 24 h. In individuals with a higher cardiovascular risk, stroke risk increased by 30 % (1.30, 1.06-1.61). Risk for cardioembolic strokes increased by 26 % (1.26, 1.06-1.50). Rapid positive or negative changes in relative humidity (>5 %) and atmospheric pressure (>10 hPa) increased stroke risk by a maximum of 30 % (1.30, 1.02-1.66) and 63 % (1.63, 1.10-2.42). In individuals with a higher cardiovascular risk, rapid changes in atmospheric pressure were associated with a four-times higher stroke risk (4.56, 1.26-16.43). Our results suggest that rapid decreases in ambient temperature and rapid changes in relative humidity and atmospheric pressure increase stroke risk under temperate climate conditions. Individuals with a high cardiovascular risk profile seem to be at greater risk.

  20. Ozone air pollution and ischaemic stroke occurrence: a case-crossover study in Nice, France

    PubMed Central

    Suissa, Laurent; Fortier, Mikael; Lachaud, Sylvain; Staccini, Pascal; Mahagne, Marie-Hélène

    2013-01-01

    Objectives Relationship between low-level air pollution and stroke is conflicting. This study was conducted to document the relationship between outdoor air pollution and ischaemic stroke occurrence. Design Time-stratified case-crossover analysis. Setting University Hospital of Nice, France. Participants All consecutive patients with ischaemic stroke living in Nice admitted in the University Hospital of Nice (France) between January 2007 and December 2011. Main outcome measure Association (adjusted OR) between daily levels of outdoor pollutants (ozone (O3), nitrogen dioxide (NO2), particulate matter (PM10) and sulfur dioxide (SO2)) and ischaemic stroke occurrence. Results 1729 patients with ischaemic stroke (mean age: 76.1±14.0 years; men: 46.7%) were enrolled. No significant association was found between stroke occurrence and short-term effects of all pollutants tested. In stratified analysis, we observed significant associations only between recurrent (n=280) and large artery ischaemic stroke (n=578) onset and short-term effect of O3 exposure. For an increase of 10 µg/m3 of O3 level, recurrent stroke risk (mean D-1, D-2 and D-3 lag) was increased by 12.1% (95% CI 1.5% to 23.9%) and large artery stroke risk (mean D-3 and D-4 lag) was increased by 8% (95% CI 2.0% to 16.6%). Linear dose–response relationship for both subgroups was found. Conclusions Our results confirm the relationship between low-level O3 exposure and ischaemic stroke in high vascular risk subgroup with linear exposure–response relation, independently of other pollutants and meteorological parameters. The physiopathological processes underlying this association between ischaemic stroke and O3 exposure remain to be investigated. PMID:24319276

  1. The effects of experimentally manipulated social status on acute eating behavior: A randomized, crossover pilot study.

    PubMed

    Cardel, M I; Johnson, S L; Beck, J; Dhurandhar, E; Keita, A D; Tomczik, A C; Pavela, G; Huo, T; Janicke, D M; Muller, K; Piff, P K; Peters, J C; Hill, J O; Allison, D B

    2016-08-01

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

  2. Effect of eplerenone on insulin action in essential hypertension: a randomised, controlled, crossover study.

    PubMed

    McMurray, E M; Wallace, I R; Ennis, C; Hunter, S J; Atkinson, A B; Bell, P M

    2014-10-01

    An association exists between hyperaldosteronism, hypertension and impaired insulin action. Eplerenone is a selective mineralocorticoid receptor antagonist; however, little is known about its effects on insulin action. The aim of this study was to determine the effect of eplerenone on insulin action in hypertensive adults, using the hyperinsulinaemic euglycaemic clamp. A randomised, controlled, double-blind, crossover design was employed. After a 6-week washout period, hypertensive, non-diabetic patients were treated with either eplerenone 25 mg twice daily or doxazosin 2 mg twice daily for 12 weeks. After each treatment period, insulin action was assessed by a hyperinsulinaemic euglycaemic clamp, with isotope dilution methodology. After washout, treatment groups were crossed over. Fifteen patients completed the study. There were no differences in fasting glucose, or fasting insulin between treatment with eplerenone or doxazosin. The measure of overall insulin sensitivity, exogenous glucose infusion rates during the last 30 min of the clamp, was similar with both treatments; 23.4 (3.9) μmol kg(-1) min(-1) after eplerenone and 23.3 (3.6) μmol kg(-1) min(-1) after doxazosin (P=0.83). Isotopically determined fasting endogenous glucose production rates were similar after both treatments (eplerenone 9.4 (0.6) μmol kg(-1) min(-1) vs doxazosin 10.6 (0.7) μmol kg(-1) min(-1)). There was a trend for lower endogenous glucose production rates during hyperinsulinaemia following eplerenone compared with doxazosin (2.0 (0.8) μmol kg(-1) min(-1) vs 4.1 (0.9) μmol kg(-1) min(-1)). There was no difference in insulin stimulated peripheral glucose utilisation rates after treatment with eplerenone or doxazosin (25.4 (3.6) μmol kg(-1) min(-1) vs 27.0 (3.9) μmol kg(-1) min(-1)). This study gives reassuring evidence of the neutral effect of eplerenone on insulin action in hypertensive, non-diabetic patients.

  3. The effects of experimentally manipulated social status on acute eating behavior: A randomized, crossover pilot study.

    PubMed

    Cardel, M I; Johnson, S L; Beck, J; Dhurandhar, E; Keita, A D; Tomczik, A C; Pavela, G; Huo, T; Janicke, D M; Muller, K; Piff, P K; Peters, J C; Hill, J O; Allison, D B

    2016-08-01

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

  4. Flooding and Emergency Room Visits for Gastrointestinal Illness in Massachusetts: A Case-Crossover Study

    PubMed Central

    Wade, Timothy J.; Lin, Cynthia J.; Jagai, Jyotsna S.; Hilborn, Elizabeth D.

    2014-01-01

    Introduction Floods and other severe weather events are anticipated to increase as a result of global climate change. Floods can lead to outbreaks of gastroenteritis and other infectious diseases due to disruption of sewage and water infrastructure and impacts on sanitation and hygiene. Floods have also been indirectly associated with outbreaks through population displacement and crowding. Methods We conducted a case-crossover study to investigate the association between flooding and emergency room visits for gastrointestinal illness (ER-GI) in Massachusetts for the years 2003 through 2007. We obtained ER-GI visits from the State of Massachusetts and records of floods from the National Oceanic and Atmospheric Association’s Storm Events Database. ER-GI visits were considered exposed if a flood occurred in the town of residence within three hazard periods of the visit: 0–4 days; 5–9 days; and 10–14 days. A time-stratified bi-directional design was used for control selection, matching on day of the week with two weeks lead or lag time from the ER-GI visit. Fixed effect logistic regression models were used to estimate the risk of ER-GI visits following the flood. Results and Conclusions A total of 270,457 ER-GI visits and 129 floods occurred in Massachusetts over the study period. Across all counties, flooding was associated with an increased risk for ER-GI in the 0–4 day period after flooding (Odds Ratio: 1.08; 95% Confidence Interval: 1.03–1.12); but not the 5–9 days (Odds Ratio: 0.995; 95% Confidence Interval: 0.955–1.04) or the 10–14 days after (Odds Ratio: 0.966, 95% Confidence Interval: 0.927–1.01). Similar results were observed for different definitions of ER-GI. The effect differed across counties, suggesting local differences in the risk and impact of flooding. Statewide, across the study period, an estimated 7% of ER-GI visits in the 0–4 days after a flood event were attributable to flooding. PMID:25329916

  5. BCS-BEC crossover in two dimensions: A quantum Monte Carlo study

    SciTech Connect

    Bertaina, G.

    2012-09-26

    We investigate the crossover from Bardeen-Cooper-Schrieffer (BCS) superfluidity to Bose-Einstein condensation (BEC) in a two-dimensional Fermi gas at T= 0 using the fixed-node diffusion Monte Carlo method. We calculate the equation of state and the gap parameter as a function of the interaction strength, observing large deviations compared to mean-field predictions. In the BEC regime our results show the important role of dimer-dimer and atom-dimer interaction effects that are completely neglected in the mean-field picture. We also consider the highly polarized gas and the competition between a polaronic and a molecular picture.

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

    PubMed Central

    Jeykodi, Shankaranarayanan; Deshpande, Jayant

    2016-01-01

    Thirty-five healthy subjects were randomly assigned to different doses of Salacia chinensis extract (200 mg, 300 mg, and 500 mg SCE) capsules and compared with placebo. It is a placebo controlled randomized crossover design study. Subjects were given oral sucrose solution along with capsules and plasma glucose and insulin responses were analyzed. Blood samples were collected at 0, 30, 60, 90, 120, and 180 minutes after administration. AUC insulin significantly lowered after ingestion of SCE. No significant adverse events were observed. Reducing glucose and insulin is very important in reducing postprandial hyperglycemia. PMID:27803937

  7. Medical Registry Data Collection Efficiency: A Crossover Study Comparing Web-Based Electronic Data Capture and a Standard Spreadsheet

    PubMed Central

    Staziaki, Pedro Vinícius; Kim, Phillip; Vadvala, Harshna V

    2016-01-01

    Background Electronic medical records and electronic data capture (EDC) have changed data collection in clinical and translational research. However, spreadsheet programs, such as Microsoft Excel, are still used as data repository to record and organize patient data for research. Objective The objective of this study is to assess the efficiency of EDC as against a standard spreadsheet in regards to time to collect data and data accuracy, measured in number of errors after adjudication. Methods This was a crossover study comparing the time to collect data in minutes between EDC and a spreadsheet. The EDC tool used was Research Electronic Data Capture (REDCap), whereas the spreadsheet was Microsoft Excel. The data collected was part of a registry of patients who underwent coronary computed tomography angiography in the emergency setting. Two data collectors with the same experience went over the same patients and collected relevant data on a case report form identical to the one used in our Emergency Department (ED) registry. Data collection tool was switched after the patient that represented half the cohort. For this, the patient cohort was exactly 30 days of our ED coronary Computed Tomography Angiography registry and the point of crossover was determined beforehand to be 15 days. We measured the number of patients admitted, and time to collect data. Accuracy was defined as absence of blank fields and errors, and was assessed by comparing data between data collectors and counting every time the data differed. Statistical analysis was made using paired t -test. Results The study included 61 patients (122 observations) and 55 variables. The crossover occurred after the 30th patient. Mean time to collect data using EDC in minutes was 6.2±2.3, whereas using Excel was 8.0±2.0 (P <.001), a difference of 1.8 minutes between both means (22%). The cohort was evenly distributed with 3 admissions in the first half of the crossover and 4 in the second half. We saw 2 (<0

  8. Mechanistic studies of photoinduced spin crossover and electron transfer in inorganic complexes.

    PubMed

    Zhang, Wenkai; Gaffney, Kelly J

    2015-04-21

    Electronic excited-state phenomena provide a compelling intersection of fundamental and applied research interests in the chemical sciences. This holds true for coordination chemistry, where harnessing the strong optical absorption and photocatalytic activity of compounds depends on our ability to control fundamental physical and chemical phenomena associated with the nonadiabatic dynamics of electronic excited states. The central events of excited-state chemistry can critically influence the dynamics of electronic excited states, including internal conversion (transitions between distinct electronic states) and intersystem crossing (transitions between electronic states with different spin multiplicities), events governed by nonadiabatic interactions between electronic states in close proximity to conical intersections, as well as solvation and electron transfer. The diversity of electronic and nuclear dynamics also makes the robust interpretation of experimental measurements challenging. Developments in theory, simulation, and experiment can all help address the interpretation and understanding of chemical dynamics in organometallic and coordination chemistry. Synthesis presents the opportunity to chemically engineer the strength and symmetry of the metal-ligand interactions. This chemical control can be exploited to understand the influence of electronic ground state properties on electronic excited-state dynamics. New time-resolved experimental methods and the insightful exploitation of established methods have an important role in understanding, and ideally controlling, the photophysics and photochemistry of transition metal complexes. Techniques that can disentangle the coupled motion of electrons and nuclear dynamics warrant emphasis. We present a review of electron localization dynamics in charge transfer excited states and the dynamics of photoinitiated spin crossover dynamics. Both electron localization and spin crossover have been investigated by

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

    NASA Astrophysics Data System (ADS)

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

    2016-04-01

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

  10. Experimental study of crossover from capillary to viscous fingering for supercritical CO2-water displacement in a homogeneous pore network.

    PubMed

    Wang, Ying; Zhang, Changyong; Wei, Ning; Oostrom, Mart; Wietsma, Thomas W; Li, Xiaochun; Bonneville, Alain

    2013-01-01

    Carbon sequestration in saline aquifers involves displacing brine from the pore space by supercritical CO(2) (scCO(2)). The displacement process is considered unstable due to the unfavorable viscosity ratio between the invading scCO(2) and the resident brine. The mechanisms that affect scCO(2)-water displacement under reservoir conditions (41 °C, 9 MPa) were investigated in a homogeneous micromodel. A large range of injection rates, expressed as the dimensionless capillary number (Ca), was studied in two sets of experiments: discontinuous-rate injection, where the micromodel was saturated with water before each injection rate was imposed, and continuous-rate injection, where the rate was increased after quasi-steady conditions were reached for a certain rate. For the discontinuous-rate experiments, capillary fingering and viscous fingering are the dominant mechanisms for low (logCa ≤ -6.61) and high injection rates (logCa ≥ -5.21), respectively. Crossover from capillary to viscous fingering was observed for logCa = -5.91 to -5.21, resulting in a large decrease in scCO(2) saturation. The discontinuous-rate experimental results confirmed the decrease in nonwetting fluid saturation during crossover from capillary to viscous fingering predicted by numerical simulations by Lenormand et al. (J. Fluid Mech.1988, 189, 165-187). Capillary fingering was the dominant mechanism for all injection rates in the continuous-rate experiment, resulting in monotonic increase in scCO(2) saturation.

  11. Reducing everyday memory and planning problems by means of a paging system: a randomised control crossover study

    PubMed Central

    Wilson, B; Emslie, H; Quirk, K; Evans, J

    2001-01-01

    OBJECTIVES—To evaluate a paging system designed to improve independence in people with memory problems and executive deficits.
METHODS—After a successful pilot study, a randomised control trial was conducted involving a crossover design with 143 people aged between 8 and 83 years. All had one or more of the following: memory, planning, attention, or organisation problems. Most had sustained a traumatic head injury or a stroke although a few had developmental learning difficulties or other conditions. The crossover design ensured that some people received a pager after a 2 week baseline whereas others were required to wait for 7 weeks after the baseline before receiving the pager. Participants were assessed at three time periods—namely, at baseline, 7 weeks, and at 14weeks postbaseline.
RESULTS—More than 80% of those who completed the 16 week trial were significantly more successful in carrying out everyday activities (such as self care, self medication, and keeping appointments) when using the pager in comparison with the baseline period. For most of these, significant improvement was maintained when they were monitored 7 weeks after returning the pager.
CONCLUSIONS—This particular paging system significantly reduces everyday failures of memory and planning in people with brain injury.

 PMID:11254770

  12. The Use and Reporting of the Cross-Over Study Design in Clinical Trials and Systematic Reviews: A Systematic Assessment

    PubMed Central

    Hambleton, Ian; Dwan, Kerry

    2016-01-01

    Background Systematic reviews of treatment interventions in stable or chronic conditions often require the synthesis of clinical trials with a cross-over design. Previous work has indicated that methodology for analysing cross-over data is inadequate in trial reports and in systematic reviews assessing trials with this design. Objective We assessed systematic review methodology for synthesising cross-over trials among Cochrane Cystic Fibrosis and Genetic Disorders Group reviews published to July 2015, and assessed the quality of reporting among the cross-over trials included in these reviews. Methodology We performed data extraction of methodology and reporting in reviews, trials identified and trials included within reviews. Principal Findings We reviewed a total of 142 Cochrane systematic reviews including 53 reviews which synthesised evidence from 218 cross-over trials. Thirty-three (63%) Cochrane reviews described a clear and appropriate method for the inclusion of cross-over data, and of these 19 (56%) used the same method to analyse results. 145 cross-over trials were described narratively or treated as parallel trials in reviews but in 30 (21%) of these trials data existed in the trial reports to account for the cross-over design. At the trial level, the analysis and presentation of results were often inappropriate or unclear, with only 69 (32%) trials presenting results that could be included in meta-analysis. Conclusions Despite development of accessible, technical guidance and training for Cochrane systematic reviewers, statistical analysis and reporting of cross-over data is inadequate at both the systematic review and the trial level. Plain language and practical guidance for the inclusion of cross-over data in meta-analysis would benefit systematic reviewers, who come from a wide range of health specialties. Minimum reporting standards for cross-over trials are needed. PMID:27409076

  13. A possible effect of methylphenidate on state anxiety: A single dose, placebo controlled, crossover study in a control group.

    PubMed

    Segev, Aviv; Gvirts, Hila Zahava; Strouse, Kevin; Mayseless, Naama; Gelbard, Hagar; Lewis, Yael Doreen; Barnea, Yael; Feffer, Kfir; Shamay-Tsoory, Simone G; Bloch, Yuval

    2016-07-30

    Methylphenidate affects state-anxiety in ADHD patients. The current study examines the effect of Methylphenidate on state-anxiety in healthy subjects. In a cross-over, randomized, controlled, double-blind study, 36 healthy subjects received either Methylphenidate or placebo. As a group, no change in state-anxiety was detected with Methylphenidate. However, participants reporting higher anxiety levels experienced a significant and specific state-anxiety reduction following Methylphenidate. Moreover, a strong negative correlation was found between the initial-level of anxiety and net-change in state-anxiety. These changes were unrelated to self-perceived attention levels. Our results point to the state-dependent effects of Methylphenidate on anxiety. PMID:27183109

  14. A possible effect of methylphenidate on state anxiety: A single dose, placebo controlled, crossover study in a control group.

    PubMed

    Segev, Aviv; Gvirts, Hila Zahava; Strouse, Kevin; Mayseless, Naama; Gelbard, Hagar; Lewis, Yael Doreen; Barnea, Yael; Feffer, Kfir; Shamay-Tsoory, Simone G; Bloch, Yuval

    2016-07-30

    Methylphenidate affects state-anxiety in ADHD patients. The current study examines the effect of Methylphenidate on state-anxiety in healthy subjects. In a cross-over, randomized, controlled, double-blind study, 36 healthy subjects received either Methylphenidate or placebo. As a group, no change in state-anxiety was detected with Methylphenidate. However, participants reporting higher anxiety levels experienced a significant and specific state-anxiety reduction following Methylphenidate. Moreover, a strong negative correlation was found between the initial-level of anxiety and net-change in state-anxiety. These changes were unrelated to self-perceived attention levels. Our results point to the state-dependent effects of Methylphenidate on anxiety.

  15. Classical to quantum crossover of the cyclotron resonance in graphene: a study of the strength of intraband absorption

    NASA Astrophysics Data System (ADS)

    Orlita, M.; Crassee, I.; Faugeras, C.; Kuzmenko, A. B.; Fromm, F.; Ostler, M.; Seyller, Th; Martinez, G.; Polini, M.; Potemski, M.

    2012-09-01

    We report on absolute magneto-transmission experiments on highly doped quasi-free-standing epitaxial graphene targeting the classical-to-quantum crossover of the cyclotron resonance. This study allows us to directly extract the carrier density and also other relevant quantities such as the quasiparticle velocity and the Drude weight, which is precisely measured from the strength of the cyclotron resonance. We find that the Drude weight is renormalized with respect to its non-interacting (or random phase approximation) value and that the renormalization is tied to the quasiparticle velocity enhancement. This finding is in agreement with recent theoretical predictions, which attribute the renormalization of the Drude weight in graphene to the interplay between broken Galilean invariance and electron-electron interactions.

  16. Route Infrastructure and the Risk of Injuries to Bicyclists: A Case-Crossover Study

    PubMed Central

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

    2012-01-01

    Objectives. We compared cycling injury risks of 14 route types and other route infrastructure features. Methods. We recruited 690 city residents injured while cycling in Toronto or Vancouver, Canada. A case-crossover design compared route infrastructure at each injury site to that of a randomly selected control site from the same trip. Results. Of 14 route types, cycle tracks had the lowest risk (adjusted odds ratio [OR] = 0.11; 95% confidence interval [CI] = 0.02, 0.54), about one ninth the risk of the reference: major streets with parked cars and no bike infrastructure. Risks on major streets were lower without parked cars (adjusted OR = 0.63; 95% CI = 0.41, 0.96) and with bike lanes (adjusted OR = 0.54; 95% CI = 0.29, 1.01). Local streets also had lower risks (adjusted OR = 0.51; 95% CI = 0.31, 0.84). Other infrastructure characteristics were associated with increased risks: streetcar or train tracks (adjusted OR = 3.0; 95% CI = 1.8, 5.1), downhill grades (adjusted OR = 2.3; 95% CI = 1.7, 3.1), and construction (adjusted OR = 1.9; 95% CI = 1.3, 2.9). Conclusions. The lower risks on quiet streets and with bike-specific infrastructure along busy streets support the route-design approach used in many northern European countries. Transportation infrastructure with lower bicycling injury risks merits public health support to reduce injuries and promote cycling. PMID:23078480

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

    PubMed Central

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

    2012-01-01

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

  18. Effects of Risperidone on Aberrant Behavior of Persons with Developmental Disabilities: I. A Double-Blind Crossover Study Using Multiple Measures.

    ERIC Educational Resources Information Center

    Zarcone, Jennifer R.; Hellings, Jessica A.; Crandall, Kurt; Reese, R. Matthew; Marquis, Janet; Fleming, Kandace; Shores, Richard; Williams, Dean; Schroeder, Stephen R.

    2001-01-01

    The efficacy of the atypical antipsychotic risperidone was evaluated in the treatment of aberrant behavior (e.g., aggression, self-injury) in 20 individuals with developmental disabilities. The study, a double-blind crossover design, identified 50 percent of participants as responders. Naturalistic observations of five participants showed that…

  19. Crossover sexual offenses.

    PubMed

    Heil, Peggy; Ahlmeyer, Sean; Simons, Dominique

    2003-10-01

    Crossover sexual offenses are defined as those in which victims are from multiple age, gender, and relationship categories. This study investigates admissions of crossover sexual offending from sex offenders participating in treatment who received polygraph testing. For 223 incarcerated and 266 paroled sexual offenders, sexual offenses were recorded from criminal history records and admissions during treatment coupled with polygraph testing. The majority of incarcerated offenders admitted to sexually assaulting both children and adults from multiple relationship types. In addition, there was a substantial increase in offenders admitting to sexually assaulting victims from both genders. In a group of incarcerated offenders who sexually assaulted children, the majority of offenders admitted to sexually assaulting both relatives and nonrelatives, and there was a substantial increase in the offenders admitting to assaulting both male and female children. Although similar trends were observed for the sample of parolees, the rates were far less dramatic. Parolees appeared to have greater levels of denial, had participated in fewer treatment sessions, and perceived greater supervision restrictions as a result of admitting additional offenses. These findings support previous research indicating that many sexual offenders do not exclusively offend against a preferred victim type. PMID:14571530

  20. Aorto-Uni-Iliac Stent Grafts with and without Crossover Femorofemoral Bypass for Treatment of Abdominal Aortic Aneurysms: A Parallel Observational Comparative Study

    PubMed Central

    Elkassaby, Mohammed; Alawy, Mahmoud; Ali, Mohamed Zaki; Tawfick, Wael A.; Sultan, Sherif

    2015-01-01

    We investigated the safety and efficacy of primary aorto-uni-iliac (AUI) endovascular aortic repair (EVAR) without fem-fem crossover in patients with abdominal aortic aneurysm (AAA) and concomitant aortoiliac occlusive disease. 537 EVARs were implemented between 2002 and 2015 in University Hospital Galway, a tertiary referral center for aortic surgery and EVAR. We executed a parallel observational comparative study between 34 patients with AUI with femorofemoral crossover (group A) and six patients treated with AUI but without the crossover (group B). Group B patients presented with infrarenal AAAs with associated total occlusion of one iliac axis and high comorbidities. Technical success was 97% (n = 33) in group A and 85% (n = 5) in group B (P = 0.31). Primary and assisted clinical success at 24 months were 88% (n = 30) and 12% (n = 4), respectively, in group A, and 85% (n = 5) and 15% (n = 1), respectively, in group B (P = 0.125). Reintervention rate was 10% (n = 3) in group A and 0% in group B (P = 0.084). No incidence of postoperative critical lower limb ischemia or amputations occurred in the follow-up period. AUI without crossover bypass is a viable option in selected cases. PMID:26770825

  1. Salivary Oxytocin Concentrations in Males following Intranasal Administration of Oxytocin: A Double-Blind, Cross-Over Study.

    PubMed

    Daughters, Katie; Manstead, Antony S R; Hubble, Kelly; Rees, Aled; Thapar, Anita; van Goozen, Stephanie H M

    2015-01-01

    The use of intranasal oxytocin (OT) in research has become increasingly important over the past decade. Although researchers have acknowledged a need for further investigation of the physiological effects of intranasal administration, few studies have actually done so. In the present double-blind cross-over study we investigated the longevity of a single 24 IU dose of intranasal OT measured in saliva in 40 healthy adult males. Salivary OT concentrations were significantly higher in the OT condition, compared to placebo. This significant difference lasted until the end of testing, approximately 108 minutes after administration, and peaked at 30 minutes. Results showed significant individual differences in response to intranasal OT administration. To our knowledge this is the largest and first all-male within-subjects design study to demonstrate the impact of intranasal OT on salivary OT concentrations. The results are consistent with previous research in suggesting that salivary OT is a valid matrix for OT measurement. The results also suggest that the post-administration 'wait-time' prior to starting experimental tasks could be reduced to 30 minutes, from the 45 minutes typically used, thereby enabling testing during peak OT concentrations. Further research is needed to ascertain whether OT concentrations after intranasal administration follow similar patterns in females, and different age groups. PMID:26669935

  2. Comparative antiplaque and antigingivitis effectiveness of tea tree oil mouthwash and a cetylpyridinium chloride mouthwash: A randomized controlled crossover study

    PubMed Central

    Rahman, Betul; Alkawas, Sausan; Al Zubaidi, Elaf A.; Adel, Omar I.; Hawas, Nuha

    2014-01-01

    Objective: The aim of this study was to compare the antiplaque and antigingivitis effects of a mouthwash containing tea tree oil (TTO) with a cetylpyridinium chloride (CPC) mouthwash. Materials and Methods: This was a randomized 4 × 4, controlled, cross-over, involving 20 healthy volunteers in a 5-day plaque re-growth model. Test mouthwashes were TTO (Tebodont®) and a mouthwash containing CPC 0.05% (Aquafresh®). A 0.12% chlorhexidine (CHX) mouthwash (Oro-Clense®) was used as positive and colored water (placebo [PLB]) as negative controls. Gingival bleeding index (GBI) and plaque index (PI) scores were recorded before and after each test period. Test periods were separated with 2 weeks washout period. Results: All four mouthwashes significantly (P < 0.001) reduced the GBI scores when compared to the baseline GBI scores. There was no significant difference between PLB and active mouthwashes in the GBI scores. CHX and CPC mouthwashes were found more effective in reducing the PI scores than TTO and PLB mouthwashes. There was no significant difference in PI scores of CHX and CPC mouthwashes. Conclusion: 0.05% CPC mouthwash can be an alternative to CHX mouthwash since it is alcohol free and found as efficient as CHX in dental plaque reduction with lesser side effects. More studies are needed to test antigingivitis effects of the mouthwashes used in this study, preferably without initial scaling and polishing. PMID:25395761

  3. Salivary Oxytocin Concentrations in Males following Intranasal Administration of Oxytocin: A Double-Blind, Cross-Over Study

    PubMed Central

    Daughters, Katie; Manstead, Antony S. R.; Hubble, Kelly; Rees, Aled; Thapar, Anita; van Goozen, Stephanie H. M.

    2015-01-01

    The use of intranasal oxytocin (OT) in research has become increasingly important over the past decade. Although researchers have acknowledged a need for further investigation of the physiological effects of intranasal administration, few studies have actually done so. In the present double-blind cross-over study we investigated the longevity of a single 24 IU dose of intranasal OT measured in saliva in 40 healthy adult males. Salivary OT concentrations were significantly higher in the OT condition, compared to placebo. This significant difference lasted until the end of testing, approximately 108 minutes after administration, and peaked at 30 minutes. Results showed significant individual differences in response to intranasal OT administration. To our knowledge this is the largest and first all-male within-subjects design study to demonstrate the impact of intranasal OT on salivary OT concentrations. The results are consistent with previous research in suggesting that salivary OT is a valid matrix for OT measurement. The results also suggest that the post-administration ‘wait-time’ prior to starting experimental tasks could be reduced to 30 minutes, from the 45 minutes typically used, thereby enabling testing during peak OT concentrations. Further research is needed to ascertain whether OT concentrations after intranasal administration follow similar patterns in females, and different age groups. PMID:26669935

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

    PubMed Central

    Korman, Paweł; Straburzyńska-Lupa, Anna; Rutkowski, Radosław; Gruszczyński, Jakub; Lewandowski, Jacek; Straburzyński-Lupa, Marcin; Łochyński, Dawid

    2015-01-01

    Objectives. The effects of Kinesio Taping (KT) on muscular performance remain largely unclear. This study aimed to investigate the acute effects of KT on the maximum concentric and eccentric quadriceps isokinetic strength. Study Design. This is a single-blinded, placebo crossover, repeated measures study. Methods. Maximum isokinetic concentric/eccentric extension torque, work, and power were assessed by an isokinetic dynamometer without taping (NT) and with KT or placebo taping (PT) in 17 healthy young men. Repeated measures one-way analysis of variance (ANOVA) was used for statistical analyses. Results. Testing concentric contractions at 60°/s or 180°/s isokinetic speed, no significant differences in peak torque (Nm), total work (J), or mean power (W) were noted among the application modes under different conditions. Testing eccentric contractions at 30°/s or 60°/s isokinetic speed, no significant differences in mentioned parameters were noted, respectively. KT on the quadriceps neither decreased nor increased muscle strength in the participants. Conclusion. KT application onto the skin overlying the quadriceps muscle does not enhance the strength or power of knee extensors in healthy men. PMID:26819953

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

    PubMed Central

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

    2016-01-01

    Dysmenorrhea is a highly prevalent complaint and highly undiagnosed gynecologic condition. Dairy products have a potential in the management of menstrual distress, and bovine lactoferrin can help the subjective dysphoria associated with dysmenorrhea. In the present study, we aimed to investigate the effects of a lactoferrin formulation isolated from cow’s milk on menstrual symptoms in volunteers. A double-blind, randomized, placebo-controlled, crossover study of the iron-lactoferrin complex (FeLf) was performed in thirty-five healthy Japanese women. Participants received the 150 mg FeLf (per day) or placebo from day ten of the luteal phase to day four of the follicular phase. The Moos Menstrual Distress Questionnaire (MDQ) was measured for menstrual distress, and heart rate variability was measured as an index of autonomic nerve balance during menses. A visual analog scale for menstrual pain, and a verbal rating scale for quality of life during the first three days of menstruation were measured. The MDQ score for the automatic nervous system subscale was lower and the parasympathetic nervous system activity was greater in FeLf than in placebo for intention-to-treat or per-protocol populations. The other variables were not different between the groups. No treatment-related side effects were observed during the study. The results indicate that FeLf can provide a beneficial effect on the psychological symptoms in women affected by menstrual distress. PMID:27258249

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

    PubMed Central

    Udani, Jay K

    2013-01-01

    Background. SuperUlam is a proprietary blend of natural ingredients aimed at supporting brain health. We aimed to evaluate the effect of SuperUlam on attention and mood in healthy adults. Methods. Twenty healthy individuals aged 35–65 were enrolled in this randomized, double-blind, placebo-controlled, crossover study. Study duration was 3 weeks and consisted of 3 visits. Measurement of cognitive function included computer-based testing of reaction time, complex attention, working memory, sustained attention, and executive functioning. Mood testing was performed via the profile of mood states (POMS) survey and the Chalder fatigue scale. Results. Cognitive function testing demonstrated a significant improvement from baseline in executive functioning, cognitive flexibility, reaction time, and working memory in the product group only (P < 0.05). When comparing the study product to placebo, the data demonstrated a significant decrease in tension, depression, and anger (P < 0.05). There was no significant difference between the product and placebo in the other measures of mood, including vigor, fatigue, confusion, and total mood disturbance. No adverse events were reported. Conclusions. Supplementation with SuperUlam is safe to consume with potential benefits to cognitive function and mood. PMID:24371452

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

    PubMed

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

    2016-01-01

    Dysmenorrhea is a highly prevalent complaint and highly undiagnosed gynecologic condition. Dairy products have a potential in the management of menstrual distress, and bovine lactoferrin can help the subjective dysphoria associated with dysmenorrhea. In the present study, we aimed to investigate the effects of a lactoferrin formulation isolated from cow's milk on menstrual symptoms in volunteers. A double-blind, randomized, placebo-controlled, crossover study of the iron-lactoferrin complex (FeLf) was performed in thirty-five healthy Japanese women. Participants received the 150 mg FeLf (per day) or placebo from day ten of the luteal phase to day four of the follicular phase. The Moos Menstrual Distress Questionnaire (MDQ) was measured for menstrual distress, and heart rate variability was measured as an index of autonomic nerve balance during menses. A visual analog scale for menstrual pain, and a verbal rating scale for quality of life during the first three days of menstruation were measured. The MDQ score for the automatic nervous system subscale was lower and the parasympathetic nervous system activity was greater in FeLf than in placebo for intention-to-treat or per-protocol populations. The other variables were not different between the groups. No treatment-related side effects were observed during the study. The results indicate that FeLf can provide a beneficial effect on the psychological symptoms in women affected by menstrual distress. PMID:27258249

  8. Airborne Pollen Concentrations and Emergency Room Visits for Myocardial Infarction: A Multicity Case-Crossover Study in Ontario, Canada.

    PubMed

    Weichenthal, Scott; Lavigne, Eric; Villeneuve, Paul J; Reeves, François

    2016-04-01

    Few studies have examined the acute cardiovascular effects of airborne allergens. We conducted a case-crossover study to evaluate the relationship between airborne allergen concentrations and emergency room visits for myocardial infarction (MI) in Ontario, Canada. In total, 17,960 cases of MI were identified between the months of April and October during the years 2004-2011. Daily mean aeroallergen concentrations (pollen and mold spores) were assigned to case and control periods using central-site monitors in each city along with daily measurements of meteorological data and air pollution (nitrogen dioxide and ozone). Odds ratios and their 95% confidence intervals were estimated using conditional logistic regression models adjusting for time-varying covariates. Risk of MI was 5.5% higher (95% confidence interval (CI): 3.4, 7.6) on days in the highest tertile of total pollen concentrations compared with days in the lowest tertile, and a significant concentration-response trend was observed (P < 0.001). Higher MI risk was limited to same-day pollen concentrations, with the largest risks being observed during May (odds ratio = 1.16, 95% CI: 1.00, 1.35) and June (odds ratio = 1.10, 95% CI: 1.00, 1.22), when tree and grass pollen are most common. Mold spore concentrations were not associated with MI. Our findings suggest that airborne pollen might represent a previously unidentified environmental risk factor for myocardial infarction.

  9. Deep mineral water accelerates recovery after dehydrating aerobic exercise: a randomized, double-blind, placebo-controlled crossover study

    PubMed Central

    2014-01-01

    Background The effect of deep mineral water (DMW) with moderate mineralization on the recovery of physical performance after prolonged dehydrating aerobic exercise in the heat was studied in nine healthy, physically active (VO2max = 45.8 ± 8.4 mL kg−1 min−1) women aged 24.0 ± 3.7 years. Methods We conducted a randomized, double-blind, placebo-controlled crossover human study to evaluate the effect of ingestion of natural mineral water extracted from a depth of 689 m on recovery from prolonged fatiguing aerobic running conducted at 30°C. Results Mean body weight decreased by 2.6–2.8% following dehydrating exercise. VO2max was 9% higher after 4 h of recovery after rehydrating with DMW compared with plain water. Leg muscle power recovered better during the slow phase of recovery and was significantly higher after 48 h of recovery after rehydrating with DMW compared with plain water. Conclusions DMW with moderate mineralization was more effective in inducing recovery of aerobic capacity and leg muscle power compared with plain water following prolonged dehydrating aerobic running exercise. PMID:25002835

  10. Fiber content of diet affects exhaled breath volatiles in fasting and postprandial state in a pilot crossover study.

    PubMed

    Raninen, Kaisa J; Lappi, Jenni E; Mukkala, Maria L; Tuomainen, Tomi-Pekka; Mykkänen, Hannu M; Poutanen, Kaisa S; Raatikainen, Olavi J

    2016-06-01

    Our pilot study examined the potential of exhaled breath analysis in studying the metabolic effects of dietary fiber (DF). We hypothesized that a high-fiber diet (HFD) containing whole grain rye changes volatile organic compound (VOC) levels in exhaled breath and that consuming a single meal affects these levels. Seven healthy men followed a week-long low-fiber diet (17 g/d) and HFD (44 g/d) in a randomized crossover design. A test meal containing 50 g of the available carbohydrates from wheat bread was served as breakfast after each week. Alveolar exhaled breath samples were analyzed at fasting state and 30, 60, and 120 minutes after this meal parallel to plasma glucose, insulin, and serum lipids. We used solid-phase microextraction and gas chromatography-mass spectrometry for detecting changes in 15 VOCs. These VOCs were acetone, ethanol, 1-propanol, 2-propanol, 1-butanol, acetic acid, propionic acid, butyric acid, valeric acid, isovaleric acid, 2-methylbutyric acid, hexanoic acid, acetoin, diacetyl, and phenol. Exhaled breath 2-methylbutyric acid in the fasting state and 1-propanol at 120 minutes decreased (P = .091 for both) after an HFD. Ingestion of the test meal increased ethanol, 1-propanol, acetoin, propionic acid, and butyric acid levels while reducing acetone, 1-butanol, diacetyl, and phenol levels. Both DF diet content and having a single meal affected breathVOCs. Exploring exhaled breath further could help to develop tools for monitoring the metabolic effects of DF. PMID:27188907

  11. Effect of long-term treatment with salmeterol on asthma control: a double blind, randomised crossover study.

    PubMed Central

    Wilding, P.; Clark, M.; Thompson Coon, J.; Lewis, S.; Rushton, L.; Bennett, J.; Oborne, J.; Cooper, S.; Tattersfield, A. E.

    1997-01-01

    OBJECTIVES: To determine the effect of adding salmeterol 50 micrograms twice daily for six months to current treatment in subjects with asthma who control their inhaled corticosteroid dose according to a management plan. DESIGN: A double blind, randomised crossover study. SETTING: Nottingham. SUBJECTS: 101 subjects with mild or moderate asthma taking at least 200 micrograms twice daily of beclomethasone dipropionate or budesonide. INTERVENTIONS: Salmeterol 50 micrograms twice daily and placebo for six months each, with a one month washout. Subjects adjusted inhaled steroid dose according to guidelines. MAIN OUTCOME MEASURE: Reduction in inhaled steroid use, exacerbations of asthma, and use of oral steroids. RESULTS: Data were available for 87 subjects. When compared with placebo salmeterol treatment was associated with a 17% reduction in inhaled steroid use (95% confidence interval 12% to 22%) with no significant difference in the number of subjects who had an exacerbation (placebo 25%, salmeterol 16%) or use of oral steroids. For secondary end points salmeterol treatment was associated with higher morning and evening peak expiratory flow and forced expiratory volume in one second; a reduction in symptoms, bronchodilator use and airway responsiveness to methacholine; and no effect on serum potassium concentration, 24 hour heart rate, or the final forced expiratory volume in one second achieved during a salbutamol dose-response study. CONCLUSIONS: In subjects who adjusted their inhaled steroid treatment according to guidelines the addition of salmeterol 50 micrograms twice daily was associated with a reduction in inhaled steroid use and improved lung function and symptom control. PMID:9167559

  12. Naturalistic conversation improves daytime motorway driving performance under a benzodiazepine: a randomised, crossover, double-blind, placebo-controlled study.

    PubMed

    Moták, Ladislav; Bayssac, Laëtitia; Taillard, Jacques; Sagaspe, Patricia; Huet, Nathalie; Terrier, Patrice; Philip, Pierre; Daurat, Agnès

    2014-06-01

    The adverse effects of benzodiazepines on driving are widely recognised. The aims of this study were both to determine the impact of naturalistic conversation on the driving ability of drivers under a benzodiazepine, and to measure the accuracy of drivers' assessments of the joint effects of the benzodiazepine and conversation. Sixteen healthy male participants (29.69 ± 3.30 years) underwent a randomised, crossover, double-blind, placebo-controlled study with the benzodiazepine lorazepam (2mg). They drove 200 km (125 miles) on a motorway in the morning. We measured two driving ability-related variables (i.e., lane-keeping performance), and collected a set of self-assessed variables (i.e., self-assessment of driving performance) during two 10-min sequences of interest (no conversation vs. conversation). An analysis of variance revealed an interaction whereby lane-keeping performance under lorazepam was worse in the no-conversation condition than in the conversation condition. No such difference was detected under placebo. Pearson's correlation coefficients revealed that self-assessments were (i) not at all predictive of lane-keeping when performed before the drive, but (ii) moderately predictive of lane-keeping performance when performed during or after the drive. We conclude that conversation with a passenger may contribute to safer lane-keeping when driving under a benzodiazepine. Moreover, a degree of awareness may be attained after some experience of driving under the influence of this type of medication. PMID:24631977

  13. Small cause - big effect: improvement in interface design results in improved data quality - a multicenter crossover study.

    PubMed

    Ahlbrandt, Janko; Henrich, Michael; Hartmann, Bernd A; Bundschuh, Bettina B; Schwarz, Julia; Klasen, Joachim; Röhrig, Rainer

    2012-01-01

    In Germany the core data set for anesthesia version 3.0 was recently introduced for external quality assurance, which includes five surgical tracer procedures. We found a low rate of correctly documented tracers when compared to procedure data (OPS-Codes) documented separately. Examination revealed that the graphical user interface (GUI) contravened the dialogue principles as defined in EN ISO 9241-110. We worked with the manufacturer to implement small improvements and roll out the software. A crossover study was conducted at a university hospital and a municipal hospital chain with five hospitals. All study sites and surgical tracer procedures combined, we found an improvement from 42% to 65% (p<0.001; N=34,610) correctly documented anesthesias. We also saw improvements for most of the observed surgical tracer procedures at all hospitals. Our results show the big effect small changes to the GUI can have on data quality. They also raise the question, if highly flexible and parameterized clinical documentation systems are suited to achieve high usability. Finding the right balance between GUIs designed by usability experts and the flexibility of parameterization by administrators will be a difficult task for the future and subject to further research. PMID:22874219

  14. Short-term effects of fine particulate air pollution on ischemic stroke occurrence: a case-crossover study.

    PubMed

    Chiu, Hui-Fen; Yang, Chun-Yuh

    2013-01-01

    This study was undertaken to determine whether there was a correlation between fine particles (PM2.5) levels and hospital admissions for ischemic stroke (IS) in Taipei, Taiwan. Hospital admissions for IS and ambient air pollution data for Taipei were obtained for the period from 2006-2010. The relative risk of hospital admissions was estimated using a case-crossover approach, controlling for weather variables, day of the week, seasonality, and long-term time trends. For the single-pollutant model (without adjustment for other pollutants), increased admissions for IS were significantly associated with higher levels of PM2.5 on both warm days (>23°C) and cool days (<23°C), with an interquartile range rise associated with a 11% (95% CI = 8-14%) and 4% (95% CI = 2-7%) elevation in admissions for IS, respectively. In the two-pollutant models, PM2.5 remained significantly increased after inclusion of sulfur dioxide (SO2) or ozone (O3) on both warm and cool days. This study provides evidence that higher levels of PM2.5 enhance the risk of hospital admissions for IS.

  15. Role of mobile phones in motor vehicle crashes resulting in hospital attendance: a case-crossover study

    PubMed Central

    McEvoy, Suzanne P; Stevenson, Mark R; McCartt, Anne T; Woodward, Mark; Haworth, Claire; Palamara, Peter; Cercarelli, Rina

    2005-01-01

    Objectives To explore the effect of drivers' use of mobile (cell) phones on road safety. Design A case-crossover study. Setting Perth, Western Australia. Participants 456 drivers aged ≥ 17 years who owned or used mobile phones and had been involved in road crashes necessitating hospital attendance between April 2002 and July 2004. Main outcome measure Driver's use of mobile phone at estimated time of crash and on trips at the same time of day in the week before the crash. Interviews with drivers in hospital and phone company's records of phone use. Results Driver's use of a mobile phone up to 10 minutes before a crash was associated with a fourfold increased likelihood of crashing (odds ratio 4.1, 95% confidence interval 2.2 to 7.7, P < 0.001). Risk was raised irrespective of whether or not a hands-free device was used (hands-free: 3.8, 1.8 to 8.0, P < 0.001; hand held: 4.9, 1.6 to 15.5, P = 0.003). Increased risk was similar in men and women and in drivers aged ≥ 30 and < 30 years. A third (n = 21) of calls before crashes and on trips during the previous week were reportedly on hand held phones. Conclusions When drivers use a mobile phone there is an increased likelihood of a crash resulting in injury. Using a hands-free phone is not any safer. PMID:16012176

  16. Safety and efficacy of vardenafil versus sertraline in the treatment of premature ejaculation: a randomised, prospective and crossover study.

    PubMed

    Mathers, M J; Klotz, T; Roth, S; Lümmen, G; Sommer, F

    2009-06-01

    We investigated safety and efficacy of vardenafil and sertraline in premature ejaculation (PE). Seventy-two men graded their primary PE on a scale of 0-8 (0 = almost never, 8 = almost always). Intravaginal ejaculatory latency time (IELT) was measured. Patients were included if they scored their PE as 4 or greater and their IELTs were less than 1.30 min. After 6 weeks of behavioural psychosexual therapy, 49 patients still had a PE of 4 or greater and an IELT less than 1.30 min and they were randomised: 6 weeks vardenafil (10 mg) or sertraline (50 mg). After a wash-out phase for 1 week, medication was changed in a cross-over design. Initially, all 72 men with PE received behavioural therapy. Twenty-three men were satisfied with treatment and excluded. The remaining 49 men graded their PE as 5.94 +/- 1.6 and IELT was 0.59 min and patients were randomised. Four men discontinued the study. Vardenafil improved PE grading: 2.7 +/- 2.1 (P < 0.01) and IELT increased to 5.01 +/- 3.69 (P < 0.001). PE grading improved 1.92 +/- 1.32, (P < 0.01) and IELT 3.12 +/- 1.89 (P < 0.001) with sertraline. It is concluded that vardenafil and sertraline are useful agents in the pharmacological treatment of PE.

  17. Effect on lipoprotein profile of replacing butter with margarine in a low fat diet: randomised crossover study with hypercholesterolaemic subjects.

    PubMed Central

    Chisholm, A.; Mann, J.; Sutherland, W.; Duncan, A.; Skeaff, M.; Frampton, C.

    1996-01-01

    OBJECTIVE--To examine the effect on lipid and lipoprotein concentrations when butter or an unsaturated margarine is used for cooking or spreading in a reduced fat diet. DESIGN--Randomised crossover study with two intervention periods of six weeks' duration separated by a five week washout. SETTING--Community setting in New Zealand. SUBJECTS--49 volunteers with polygenic hypercholesterolaemia and baseline total cholesterol concentration in the range 5.5-7.9 mmol/l. MAIN OUTCOME MEASURES--Concentrations of total and low density lipoprotein, Lp(a) lipoprotein, high density lipoprotein, apolipoprotein B 100, and apolipoprotein A I. RESULTS--Concentrations of low density lipoprotein cholesterol and apolipoprotein B were about 10% lower with margarine than with butter. Lp(a) lipoprotein and high density lipoprotein cholesterol concentrations were similar with the two diets. CONCLUSION--Despite concerns about adverse effects on lipoproteins of trans fatty acids in margarines, the use of unsaturated margarine rather than butter by hypercholesterolaemic people is associated with a lipoprotein profile that would be expected to reduce cardiovascular risk. PMID:8616303

  18. Repetitive transcranial magnetic stimulation over the orbitofrontal cortex for obsessive-compulsive disorder: a double-blind, crossover study

    PubMed Central

    Nauczyciel, C; Le Jeune, F; Naudet, F; Douabin, S; Esquevin, A; Vérin, M; Dondaine, T; Robert, G; Drapier, D; Millet, B

    2014-01-01

    This pilot study was designed to assess the efficacy of low-frequency repetitive transcranial magnetic stimulation (rTMS) over the right orbitofrontal cortex (OFC) by means of a double-cone coil in patients suffering from obsessive-compulsive disorder. We hypothesized that low-frequency stimulation of the OFC would lead to a reduction in clinical symptoms, as measured on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). A randomized, double-blind, crossover design was implemented with two 1-week treatment periods (active stimulation versus sham stimulation) separated by a 1-month washout period. Concomitantly, a subgroup of patients underwent a positron emission tomography (PET) scan after each stimulation sequence. Statistical analyses compared the Y-BOCS scores at the end of each period. At day 7, we observed a significant decrease from baseline in the Y-BOCS scores, after both active (P<0.01) and sham stimulation (P=0.02). This decrease tended to be larger after active stimulation than after sham stimulation: −6 (−29, 0) points versus −2 (−20, 4) points (P=0.07). Active versus sham PET scan contrasts showed that stimulation was related to a bilateral decrease in the metabolism of the OFC. The OFC should definitely be regarded as a key neuroanatomical target for rTMS, as it is easier to reach than either the striatum or the subthalamic nucleus, structures favored in neurosurgical approaches. PMID:25203167

  19. Safety and efficacy of vardenafil versus sertraline in the treatment of premature ejaculation: a randomised, prospective and crossover study.

    PubMed

    Mathers, M J; Klotz, T; Roth, S; Lümmen, G; Sommer, F

    2009-06-01

    We investigated safety and efficacy of vardenafil and sertraline in premature ejaculation (PE). Seventy-two men graded their primary PE on a scale of 0-8 (0 = almost never, 8 = almost always). Intravaginal ejaculatory latency time (IELT) was measured. Patients were included if they scored their PE as 4 or greater and their IELTs were less than 1.30 min. After 6 weeks of behavioural psychosexual therapy, 49 patients still had a PE of 4 or greater and an IELT less than 1.30 min and they were randomised: 6 weeks vardenafil (10 mg) or sertraline (50 mg). After a wash-out phase for 1 week, medication was changed in a cross-over design. Initially, all 72 men with PE received behavioural therapy. Twenty-three men were satisfied with treatment and excluded. The remaining 49 men graded their PE as 5.94 +/- 1.6 and IELT was 0.59 min and patients were randomised. Four men discontinued the study. Vardenafil improved PE grading: 2.7 +/- 2.1 (P < 0.01) and IELT increased to 5.01 +/- 3.69 (P < 0.001). PE grading improved 1.92 +/- 1.32, (P < 0.01) and IELT 3.12 +/- 1.89 (P < 0.001) with sertraline. It is concluded that vardenafil and sertraline are useful agents in the pharmacological treatment of PE. PMID:19400851

  20. Is Skin-Touch Sham Needle Not Placebo? A Double-Blind Crossover Study on Pain Alleviation

    PubMed Central

    Homma, Ikuo; Izumizaki, Masahiko

    2015-01-01

    It remains an open question whether placebo/sham acupuncture, in which the needle tip presses the skin, can be used as a placebo device for research on pain. We compare the analgesic effect of the skin-touch placebo needle with that of the no-touch placebo needle, in which the needle tip does not touch the skin, in a double-blind crossover manner including no-treatment control in 23 healthy volunteers. The subjects received painful electrical stimulation in the forearm before and during needle retention to the LI 4 acupoint and after the removal of the needle and rated pain intensity using a visual analogue scale. We found no significant difference in analgesic effects among the skin-touch placebo needle, no-touch placebo needle, and no-treatment control at every point before, during, and after the treatments (p > 0.05). The results indicate that the skin-touch placebo needle can be used as a placebo device in clinical studies on pain. PMID:26064153

  1. Gaseous air pollution and acute myocardial infarction mortality in Hong Kong: A time-stratified case-crossover study

    NASA Astrophysics Data System (ADS)

    Lin, Hualiang; An, Qingzhu; Luo, Chao; Pun, Vivian C.; Chan, Chi Sing; Tian, Linwei

    2013-09-01

    Acute myocardial infarction (AMI) is a common disease with serious consequences in mortality and morbidity. An association between gaseous air pollution and AMI has been suggested, but the epidemiological evidence is still limited. For the study period 1998-2010, daily counts of AMI deaths were collected, as well as daily air pollution data including concentrations of particulates (PM10), nitrogen dioxide (NO2), sulfur dioxide (SO2), ozone (O3) and carbon monoxide (CO) were also obtained. The associations between gaseous air pollutants and AMI mortality were estimated using time-stratified case-crossover analyses. NO2 and SO2 were found to be significantly associated with increased AMI mortality. The odds ratios (ORs) were 1.0455 (95% confidence interval (CI): 1.017-1.0748) and 1.0256 (95% CI: 1.0027-1.0489) for an interquartile range (IQR) increase in the current day's NO2 and SO2 concentration, respectively, and this association persisted in 2-pollutant models; and no association was observed for CO and O3. It is likely that exposure to elevated ambient NO2 and SO2 air pollution contributed to increased AMI mortality.

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

    PubMed Central

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

    2015-01-01

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

  3. The effect of aromatherapy abdominal massage on alleviating menstrual pain in nursing students: a prospective randomized cross-over study.

    PubMed

    Marzouk, Tyseer M F; El-Nemer, Amina M R; Baraka, Hany N

    2013-01-01

    Dysmenorrhea is a common cause of sickness absenteeism from both classes and work. This study investigated the effect of aromatherapy massage on a group of nursing students who are suffering of primary dysmenorrhea. A randomized blind clinical trial of crossover design was used. In the first treatment phase, group 1 (n = 48) received aromatherapy abdominal massage once daily for seven days prior to menstruation using the essential oils (cinnamon, clove, rose, and lavender in a base of almond oil). Group 2 (n = 47) received the same intervention but with placebo oil (almond oil). In the second treatment phase, the two groups switched to alternate regimen. Level and duration of pain and the amount of menstrual bleeding were evaluated at the baseline and after each treatment phase. During both treatment phases, the level and duration of menstrual pain and the amount of menstrual bleeding were significantly lower in the aromatherapy group than in the placebo group. These results suggests that aromatherapy is effective in alleviating menstrual pain, its duration and excessive menstrual bleeding. Aromatherapy can be provided as a nonpharmacological pain relief measure and as a part of nursing care given to girls suffering of dysmenorrhea, or excessive menstrual bleeding.

  4. The effect of levetiracetam on focal nocturnal epileptiform activity during sleep--a placebo-controlled double-blind cross-over study.

    PubMed

    Larsson, Pål Gunnar; Bakke, Kristin A; Bjørnæs, Helge; Heminghyt, Einar; Rytter, Elisif; Brager-Larsen, Line; Eriksson, Ann-Sofie

    2012-05-01

    Electric Status Epilepticus during Sleep (ESES) occurs in children with and without epilepsy. It may be related to disturbances as autism spectrum disorder, attention-deficit hyperactivity disorder and acquired aphasia (Landau-Kleffner syndrome). Antiepileptic drug (AED) treatment has been reported in small studies without placebo control. This study was designed to assess AED effect in a placebo-controlled double-blind cross-over study. Levetiracetam (LEV) was chosen based on clinical evidence. Eighteen patients fulfilled the inclusion criteria. The mean spike index at baseline was 56, falling to a mean of 37 at the end of the LEV treatment period. Assessed with a 2-way ANOVA, there is a significant treatment effect (p<0.0002). To the best of our knowledge, this is the first placebo-controlled double-blind cross-over study for any AED in patients with ESES. The effect of LEV is comparable with its effect in treatment of epileptic seizures.

  5. Association between flood and the morbidity of bacillary dysentery in Zibo City, China: a symmetric bidirectional case-crossover study

    NASA Astrophysics Data System (ADS)

    Zhang, Feifei; Ding, Guoyong; Liu, Zhidong; Zhang, Caixia; Jiang, Baofa

    2016-04-01

    This study examined the relationship between daily morbidity of bacillary dysentery and flood in 2007 in Zibo City, China, using a symmetric bidirectional case-crossover study. Odds ratios (ORs) and 95 % confidence intervals (CIs) on the basis of multivariate model and stratified analysis at different lagged days were calculated to estimate the risk of flood on bacillary dysentery. A total of 902 notified bacillary dysentery cases were identified during the study period. The median of case distribution was 7-year-old and biased to children. Multivariable analysis showed that flood was associated with an increased risk of bacillary dysentery, with the largest OR of 1.849 (95 % CI 1.229-2.780) at 2-day lag. Gender-specific analysis showed that there was a significant association between flood and bacillary dysentery among males only (ORs >1 from lag 1 to lag 5), with the strongest lagged effect at 2-day lag (OR = 2.820, 95 % CI 1.629-4.881), and the result of age-specific indicated that youngsters had a slightly larger risk to develop flood-related bacillary dysentery than older people at one shorter lagged day (OR = 2.000, 95 % CI 1.128-3.546 in youngsters at lag 2; OR = 1.879, 95 % CI 1.069-3.305 in older people at lag 3). Our study has confirmed that there is a positive association between flood and the risk of bacillary dysentery in selected study area. Males and youngsters may be the vulnerable and high-risk populations to develop the flood-related bacillary dysentery. Results from this study will provide recommendations to make available strategies for government to deal with negative health outcomes due to floods.

  6. Comparison of different exposure settings in a case--crossover study on air pollution and daily mortality: counterintuitive results.

    PubMed

    Zauli Sajani, Stefano; Hänninen, Otto; Marchesi, Stefano; Lauriola, Paolo

    2011-01-01

    Because of practical problems associated with measurement of personal exposures to air pollutants in larger populations, almost all epidemiological studies assign exposures based on fixed-site ambient air monitoring stations. In the presence of multiple monitoring stations at different locations, the selection of them may affect the observed epidemiological concentration--response (C-R) relationships. In this paper, we quantify these impacts in an observational ecologic case--crossover study of air pollution and mortality. The associations of daily concentrations of PM(10), O(3), and NO(2) with daily all-cause non-violent mortality were investigated using conditional logistic regression to estimate percent increase in the risk of dying for an increase of 10 μg/m(3) in the previous day air pollutant concentrations (lag 1). The study area covers the six main cities in the central-western part of Emilia-Romagna region (population of 1.1 million). We used four approaches to assign exposure to air pollutants for each individual considered in the study: nearest background station; city average of all stations available; average of all stations in a macro-area covering three cities and average of all six cities in the study area (50 × 150 km(2)). Odds ratios generally increased enlarging the spatial dimension of the exposure definition and were highest for six city-average exposure definition. The effect is especially evident for PM(10), and similar for NO(2), whereas for ozone, we did not find any change in the C-R estimates. Within a geographically homogeneous region, the spatial aggregation of monitoring station data leads to higher and more robust risk estimates for PM(10) and NO(2), even if monitor-to-monitor correlations showed a light decrease with distance. We suggest that the larger aggregation improves the representativity of the exposure estimates by decreasing exposure misclassification, which is more profound when using individual stations vs regional

  7. Effects of almond and pistachio consumption on gut microbiota composition in a randomised cross-over human feeding study.

    PubMed

    Ukhanova, Maria; Wang, Xiaoyu; Baer, David J; Novotny, Janet A; Fredborg, Marlene; Mai, Volker

    2014-06-28

    The modification of microbiota composition to a 'beneficial' one is a promising approach for improving intestinal as well as overall health. Natural fibres and phytochemicals that reach the proximal colon, such as those present in various nuts, provide substrates for the maintenance of healthy and diverse microbiota. The effects of increased consumption of specific nuts, which are rich in fibre as well as various phytonutrients, on human gut microbiota composition have not been investigated to date. The objective of the present study was to determine the effects of almond and pistachio consumption on human gut microbiota composition. We characterised microbiota in faecal samples collected from volunteers in two separate randomised, controlled, cross-over feeding studies (n 18 for the almond feeding study and n 16 for the pistachio feeding study) with 0, 1·5 or 3 servings/d of the respective nuts for 18 d. Gut microbiota composition was analysed using a 16S rRNA-based approach for bacteria and an internal transcribed spacer region sequencing approach for fungi. The 16S rRNA sequence analysis of 528 028 sequence reads, retained after removing low-quality and short-length reads, revealed various operational taxonomic units that appeared to be affected by nut consumption. The effect of pistachio consumption on gut microbiota composition was much stronger than that of almond consumption and included an increase in the number of potentially beneficial butyrate-producing bacteria. Although the numbers of bifidobacteria were not affected by the consumption of either nut, pistachio consumption appeared to decrease the number of lactic acid bacteria (P< 0·05). Increasing the consumption of almonds or pistachios appears to be an effective means of modifying gut microbiota composition.

  8. Efficacy comparison between simple mixed-dilution and simple mid-dilution on-line hemodiafiltration techniques: a crossover study.

    PubMed

    Susantitaphong, Paweena; Tiranathanagul, Khajohn; Katavetin, Pisut; Hanwiwatwong, Orawadee; Wittayalertpanya, Supeecha; Praditpornsilpa, Kearkiat; Tungsanga, Kriang; Eiam-Ong, Somchai

    2012-12-01

    Mid-dilution and mixed-dilution on-line hemodiafiltration (OL-HDF) techniques are innovated to overcome the limitations of two standard techniques including predilution and postdilution. Unfortunately, the head-to-head comparisons between these two novel techniques in the same study are still limited. Moreover, the original mid-dilution and mixed-dilution OL-HDF need special dialyzers and special machines. In the present study, simple mid-dilution and simple mixed-dilution OL-HDF were settled with the aim for clinical use in general hemodialysis (HD) centers. The efficacies of uremic toxins removal between both modalities were measured and compared. This prospective randomized crossover study was conducted on 12 stable HD patients undergoing simple mixed-dilution and simple mid-dilution OL-HDF techniques. HD prescriptions were similar in both techniques. The dialysis efficacies were determined by calculating small- (urea, creatinine, and phosphate) and middle-molecule (beta-2 microglobulin [β2M]) removal. Moreover, potential complications such as high transmembrane pressure (TMP) and protein loss were also observed. Simple mixed-dilution OL-HDF provided significantly greater clearances of urea, creatinine, and β2M when compared with the simple mid-dilution OL-HDF techniques. Phosphate clearances in both techniques were comparable. In addition, TMP and dialysate albumin loss were not different. There were no intradialytic complications in both techniques. Simple mixed-dilution OL-HDF could provide greater efficacy for small- and middle-molecule clearances and acceptable potential risks, while phosphate removal is comparable.

  9. Bioequivalence of Generic and Brand Name Clozapine in Korean Schizophrenic Patients: A Randomized, Two-Period, Crossover Study

    PubMed Central

    Woo, Young Sup; Wang, Hee-Ryung; Yoon, Bo-Hyun; Lee, Sang-Yeol; Lee, Kwang Hun; Seo, Jeong Seok

    2015-01-01

    Objective Clozapine is the treatment of choice for refractory schizophrenia. The aim of this study was to compare the pharmacokinetics of the brand name (Clozaril) formulation and a generic formulation (Clzapine) of clozapine in Korean schizophrenic patients. Methods A prospective, randomized, crossover study was conducted to evaluate the steady-state pharmacokinetic profiles of Clozaril and Clzapine. Schizophrenic patients were randomized to receive either the brand name or generic formulation (100 mg twice daily) for 10 days, followed by the other formulation for 10 days. Plasma samples were collected on the last day of each treatment period. Results Twenty-two of 28 patients (78.6%) completed the study. The mean Cmax,ss values for Clzapine and Clozaril were 524.62 and 551.18 ng/mL, and the mean AUC0-12 values were 4479.90 hr·ng/mL and 4724.56 hr·ng/mL, respectively. The 90% CI values for the natural logarithmically transformed Cmax,ss and AUC0-12 ratios (Clzapine to Clozaril) after a single oral dose (100 mg) were 0.934 (0.849-1.028) and 0.936 (0.869-1.008), respectively. Five patients (20.8%) among 24 patients who took Clzapine reported 11 adverse events and six adverse events were reported by four patients (15.4%) among 26 who took Clozaril; there were no significant differences on physical examination or in vital signs, ECG, and laboratory tests between groups. Conclusion Generic clozapine (Clzapine) appears to be bioequivalent to brand name clozapine (Clozaril). PMID:26207129

  10. The Effects of Coarse Particles on Daily Mortality: A Case-Crossover Study in a Subtropical City, Taipei, Taiwan

    PubMed Central

    Cheng, Meng-Hsuan; Chiu, Hui-Fen; Yang, Chun-Yuh

    2016-01-01

    Many studies have examined the effects of air pollution on daily mortality over the past two decades. However, information on the relationship between levels of coarse particles (PM2.5–10) and daily mortality is relatively sparse due to the limited availability of monitoring data. Furthermore, the results are inconsistent. In the current study, the association between coarse particle levels and daily mortality in Taipei, Taiwan’s largest city, which has a subtropical climate, was undertaken for the period 2006–2008 using a time-stratified case-crossover analysis. For the single pollutant model (without adjustment for other pollutants), PM2.5–10 showed statistically significant association with total mortality both on warm and cool days, with an interquartile range increase associated with a 11% (95% CI = 6%–17%) and 4% (95% CI = 1%–7%) rise in number of total deaths, respectively. In two-pollutant models, PM2.5–10 remained significant effects on total mortality after the inclusion of SO2 and O3 both on warm and cool days. We observed no significant associations between PM2.5–10 and daily mortality from respiratory diseases both on warm and cool days. For daily mortality from circulatory diseases, the effect of PM2.5–10 remained significant when SO2 or O3 was added in the regression model both on warm and cool days. Future studies of this type in cities with varying climates and cultures are needed. PMID:27011197

  11. Short-term effects of phenylephrine on systemic and regional hemodynamics in patients with septic shock: a crossover pilot study.

    PubMed

    Morelli, Andrea; Lange, Matthias; Ertmer, Christian; Dünser, Martin; Rehberg, Sebastian; Bachetoni, Alessandra; D'Alessandro, Marladomenica; Van Aken, Hugo; Guarracino, Fabio; Pietropaoli, Paolo; Traber, Daniel L; Westphal, Martin

    2008-04-01

    Clinical studies evaluating the use of phenylephrine in septic shock are lacking. The present study was designed as a prospective, crossover pilot study to compare the effects of norepinephrine (NE) and phenylephrine on systemic and regional hemodynamics in patients with catecholamine-dependent septic shock. In 15 septic shock patients, NE (0.82 +/- 0.689 microg x kg(-1) x min(-1)) was replaced with phenylephrine (4.39 +/- 5.23 microg x kg(-1) x min(-1)) titrated to maintain MAP between 65 and 75 mmHg. After 8 h of phenylephrine infusion treatment was switched back to NE. Data from right heart catheterization, acid-base balance, thermo-dye dilution catheter, gastric tonometry, and renal function were obtained before, during, and after replacing NE with phenylephrine. Variables of systemic hemodynamics, global oxygen transport, and acid-base balance remained unchanged after replacing NE with phenylephrine except for a significant decrease in heart rate (phenylephrine, 89 +/- 18 vs. NE, 93 +/- 18 bpm; P < 0.05). However, plasma disappearance rate (phenylephrine, 13.5 +/- 7.1 vs. NE, 16.4 +/- 8.7% x min(-1)) and clearance of indocyanine green (phenylephrine, 330 +/- 197 vs. NE, 380 +/- 227 mL x min(-1) x m(-2)), as well as creatinine clearance (phenylephrine, 81.3 +/- 78.4 vs. NE, 94.3 +/- 93.5 mL x min(-1)) were significantly decreased by phenylephrine infusion (each P < 0.05). In addition, phenylephrine increased arterial lactate concentrations as compared with NE infusion (1.7 +/- 1.0 vs. 1.4 +/- 1.1 mM; P < 0.05). After switching back to NE, all variables returned to values obtained before phenylephrine infusion except creatinine clearance and gastric tonometry values. Our results suggest that for the same MAP, phenylephrine causes a more pronounced hepatosplanchnic vasoconstriction as compared with NE.

  12. Evaluation of mint efficacy regarding dysmenorrhea in comparison with mefenamic acid: A double blinded randomized crossover study

    PubMed Central

    Masoumi, Seyedeh Zahra; Asl, Horieh Rezvani; Poorolajal, Jalal; Panah, Mohammad Hosseini; Oliaei, Seyedeh Reyhaneh

    2016-01-01

    Background: Menthol is the most important active material in mint and different mechanisms have been suggested for the way mint functions, most of which emphasize its analgesic effect owing to the presence of a group of temporary protein receptors. This study investigates the efficacy of peppermint capsule in the treatment of primary dysmenorrhea, in comparison with Mefenamic Acid and placebo. Materials and Methods: This was a prospective, double-blinded, crossover study and was conducted on 127 girl students studying in Hamadan University of Medical Sciences who had experienced primary dysmenorrhea. Each participant was asked to take one of the drugs including Mefenamic Acid and Mint, starting from the first menstruation for 3 days. At the end of each period, a questionnaire was used to gather information; through the volunteer herself, pain intensity was recorded according to visual analog scale (VAS), duration of pain according to COX questionnaire, and bleeding amount according to pictorial blood loss assessment chart (PBAC) chart (Hygham). Results: Average pain intensity and duration of pain were significantly lower after intake of Mefenamic Acid and Mint (P < 0.05). Average bleeding was significantly lower in those taking Mefenamic Acid capsule than in those taking peppermint extract (P < 0.05). Nausea and diarrhea were lower in the mint group than in Mefenamic Acid group. But analgesic usage was lower in Mefenamic Acid group than in peppermint group (P < 0.05). Conclusions: While the bleeding amount did not significantly change, pain and its severity and all the clinical signs and symptoms decreased after taking peppermint extract. Because the side effect of herbal drugs is lower than other medicinal drugs, using mint is advised for treating dysmenorrhea symptoms. PMID:27563318

  13. Effects of American ginseng (Panax quinquefolius) on neurocognitive function: an acute, randomised, double-blind, placebo-controlled, crossover study

    PubMed Central

    Ossoukhova, Anastasia; Owen, Lauren; Ibarra, Alvin; Pipingas, Andrew; He, Kan; Roller, Marc; Stough, Con

    2010-01-01

    Rationale Over the last decade, Asian ginseng (Panax ginseng) has been shown to improve aspects of human cognitive function. American ginseng (Panax quinquefolius) has a distinct ginsenoside profile from P. ginseng, promising cognitive enhancing properties in preclinical studies and benefits processes linked to human cognition. Objectives The availability of a highly standardised extract of P. quinquefolius (Cereboost™) led us to evaluate its neurocognitive properties in humans for the first time. Methods This randomised, double-blind, placebo-controlled, crossover trial (N = 32, healthy young adults) assessed the acute mood, neurocognitive and glycaemic effects of three doses (100, 200 400 mg) of Cereboost™ (P. quinquefolius standardised to 10.65% ginsenosides). Participants' mood, cognitive function and blood glucose were measured 1, 3 and 6 h following administration. Results There was a significant improvement of working memory (WM) performance associated with P. quinquefolius. Corsi block performance was improved by all doses at all testing times. There were differential effects of all doses on other WM tasks which were maintained across the testing day. Choice reaction time accuracy and ‘calmness’ were significantly improved by 100 mg. There were no changes in blood glucose levels. Conclusions This preliminary study has identified robust working memory enhancement following administration of American ginseng. These effects are distinct from those of Asian ginseng and suggest that psychopharmacological properties depend critically on ginsenoside profiles. These results have ramifications for the psychopharmacology of herbal extracts and merit further study using different dosing regimens and in populations where cognition is fragile. PMID:20676609

  14. The Effects of Particulate Matter Sources on Daily Mortality: A Case-Crossover Study of Barcelona, Spain

    PubMed Central

    Tobias, Aurelio; Querol, Xavier; Alastuey, Andrés; Amato, Fulvio; Pey, Jorge; Pérez, Noemí; Sunyer, Jordi

    2011-01-01

    Background: Dozens of studies link acute exposure to particulate matter (PM) air pollution with premature mortality and morbidity, but questions remain about which species and sources in the vast PM mixture are responsible for the observed health effects. Although a few studies exist on the effects of species and sources in U.S. cities, European cities—which have a higher proportion of diesel engines and denser urban populations—have not been well characterized. Information on the effects of specific sources could aid in targeting pollution control and in articulating the biological mechanisms of PM. Objectives: Our study examined the effects of various PM sources on daily mortality for 2003 through 2007 in Barcelona, a densely populated city in the northeast corner of Spain. Methods: Source apportionment for PM ≤ 2.5 μm and ≤ 10 µm in aerodynamic diameter (PM2.5 and PM10) using positive matrix factorization identified eight different factors. Case-crossover regression analysis was used to estimate the effects of each factor. Results: Several sources of PM2.5, including vehicle exhaust, fuel oil combustion, secondary nitrate/organics, minerals, secondary sulfate/organics, and road dust, had statistically significant associations (p < 0.05) with all-cause and cardiovascular mortality. Also, in some cases relative risks for a respective interquartile range increase in concentration were higher for specific sources than for total PM2.5 mass. Conclusions: These results along with those from our multisource models suggest that traffic, sulfate from shipping and long-range transport, and construction dust are important contributors to the adverse health effects linked to PM. PMID:21846610

  15. Open-Label Crossover Study of Primaquine and Dihydroartemisinin-Piperaquine Pharmacokinetics in Healthy Adult Thai Subjects

    PubMed Central

    Hanboonkunupakarn, Borimas; Ashley, Elizabeth A.; Jittamala, Podjanee; Tarning, Joel; Pukrittayakamee, Sasithon; Hanpithakpong, Warunee; Chotsiri, Palang; Wattanakul, Thanaporn; Panapipat, Salwaluk; Lee, Sue J.; Day, Nicholas P. J.

    2014-01-01

    Dihydroartemisinin-piperaquine is an artemisinin-based combination treatment (ACT) recommended by the WHO for uncomplicated Plasmodium falciparum malaria, and it is being used increasingly for resistant vivax malaria where combination with primaquine is required for radical cure. The WHO recently reinforced its recommendations to add a single dose of primaquine to ACTs to reduce P. falciparum transmission in low-transmission settings. The pharmacokinetics of primaquine and dihydroartemisinin-piperaquine were evaluated in 16 healthy Thai adult volunteers in a randomized crossover study. Volunteers were randomized to two groups of three sequential hospital admissions to receive 30 mg (base) primaquine, 3 tablets of dihydroartemisinin-piperaquine (120/960 mg), and the drugs together at the same doses. Blood sampling was performed over 3 days following primaquine and 36 days following dihydroartemisinin-piperaquine dosing. Pharmacokinetic assessment was done with a noncompartmental approach. The drugs were well tolerated. There were no statistically significant differences in dihydroartemisinin and piperaquine pharmacokinetics with or without primaquine. Dihydroartemisinin-piperaquine coadministration significantly increased plasma primaquine levels; geometric mean ratios (90% confidence interval [CI]) of primaquine combined versus primaquine alone for maximum concentration (Cmax), area under the concentration-time curve from 0 h to the end of the study (AUC0–last), and area under the concentration-time curve from 0 h to infinity (AUC0–∞) were 148% (117 to 187%), 129% (103 to 163%), and 128% (102 to 161%), respectively. This interaction is similar to that described recently with chloroquine and may result in an enhanced radical curative effect. (This study has been registered at ClinicalTrials.gov under registration no. NCT01525511.) PMID:25267661

  16. Antithrombotic properties of rafigrelide: a phase 1, open-label, non-randomised, single-sequence, crossover study.

    PubMed

    Balasubramaniam, K; Viswanathan, G; Dragone, J; Grose-Hodge, R; Martin, P; Troy, S; Preston, P; Zaman, A G

    2014-07-01

    Platelets play a central role in atherothrombotic events. We investigated the effect of a novel platelet-lowering agent, rafigrelide, on thrombus formation and characteristics. In this phase 1, open-label, non-randomised, single-sequence, crossover study, healthy male volunteers received rafigrelide for 14 days (Period 1). Following a ≥6-week washout period, they then received rafigrelide + acetylsalicylic acid (ASA) for 14 days (Period 2). Thrombus formation was assessed ex vivo using the Badimon perfusion chamber, and thrombus characteristics were assessed using thromboelastography. A total of 15 volunteers were enrolled in the study and were assigned to Panel A or Panel B, which had different schedules of assessments. In Panel A, after treatment with rafigrelide alone (Period 1), mean (± standard deviation) platelet count was reduced from 283 (± 17) × 10⁹/l at Day 1, to 125 (± 47) × 10⁹/l at Day 14 (n=6) and thrombus area reduced under high and low shear conditions. Reductions in thrombus area under high shear conditions correlated with reductions in platelet count (r²=0.11, p=0.022; n=12). Rafigrelide treatment prolonged clot formation time and reduced clot strength. The addition of ASA to rafigrelide (Period 2) had no additional effect on platelet count or thrombus area under high or low shear conditions. Similar results were seen in Panel B for all parameters. The most common adverse events (≥3 participants per period) were thrombocytopenia and headache. While confirming the platelet-lowering effects of rafigrelide, this early phase study also indicates that rafigrelide has antithrombotic properties under both high and low shear conditions. PMID:24553755

  17. A Novel Magnetic Stimulator Increases Experimental Pain Tolerance in Healthy Volunteers - A Double-Blind Sham-Controlled Crossover Study

    PubMed Central

    Kortekaas, Rudie; Konopka, Karl-Heinz; Harbers, Marten; van der Hoeven, Johannes H.; van Wijhe, Marten; Aleman, André; Maurits, Natasha M.

    2013-01-01

    The ‘complex neural pulse’TM (CNP) is a neuromodulation protocol employing weak pulsed electromagnetic fields (PEMF). A pioneering paper reported an analgesic effect in healthy humans after 30 minutes of CNP-stimulation using three nested whole head coils. We aimed to devise and validate a stimulator with a novel design entailing a multitude of small coils at known anatomical positions on a head cap, to improve applicability. The main hypothesis was that CNP delivery with this novel device would also increase heat pain thresholds. Twenty healthy volunteers were enrolled in this double-blind, sham-controlled, crossover study. Thirty minutes of PEMF (CNP) or sham was applied to the head. After one week the other treatment was given. Before and after each treatment, primary and secondary outcomes were measured. Primary outcome was heat pain threshold (HPT) measured with thermal quantitative sensory testing. Other outcomes were warmth detection threshold, and aspects of cognition, emotion and motor performance. As hypothesized heat pain threshold was significantly increased after the PEMF stimulation. All other outcomes were unaltered by the PEMF but there was a trend level reduction of cognitive performance after PEMF stimulation as measured by the digit-symbol substitution task. Results from this pilot study suggest that our device is able to stimulate the brain and to modulate its function. This is in agreement with previous studies that used similar magnetic field strengths to stimulate the brain. Specifically, pain control may be achieved with PEMF and for this analgesic effect, coil design does not appear to play a dominant role. In addition, the flexible configuration with small coils on a head cap improves clinical applicability. Trial Registration Dutch Cochrane Centre NTR1093 PMID:23620795

  18. Forest Fire Smoke Exposures and Out-of-Hospital Cardiac Arrests in Melbourne, Australia: A Case-Crossover Study

    PubMed Central

    Straney, Lahn D.; Erbas, Bircan; Abramson, Michael J.; Keywood, Melita; Smith, Karen; Sim, Malcolm R.; Glass, Deborah C.; Del Monaco, Anthony; Haikerwal, Anjali; Tonkin, Andrew M.

    2015-01-01

    Background Millions of people can potentially be exposed to smoke from forest fires, making this an important public health problem in many countries. Objective In this study we aimed to measure the association between out-of-hospital cardiac arrest (OHCA) and forest fire smoke exposures in a large city during a severe forest fire season, and estimate the number of excess OHCAs due to the fire smoke. Methods We investigated the association between particulate matter (PM) and other air pollutants and OHCA using a case-crossover study of adults (≥ 35 years of age) in Melbourne, Australia. Conditional logistic regression models were used to derive estimates of the percent change in the rate of OHCA associated with an interquartile range (IQR) increase in exposure. From July 2006 through June 2007, OHCA data were collected from the Victorian Ambulance Cardiac Arrest Registry. Hourly air pollution concentrations and meteorological data were obtained from a central monitoring site. Results There were 2,046 OHCAs with presumed cardiac etiology during our study period. Among men during the fire season, greater increases in OHCA were observed with IQR increases in the 48-hr lagged PM with diameter ≤ 2.5 μm (PM2.5) (8.05%; 95% CI: 2.30, 14.13%; IQR = 6.1 μg/m3) or ≤ 10 μm (PM10) (11.1%; 95% CI: 1.55, 21.48%; IQR = 13.7 μg/m3) and carbon monoxide (35.7%; 95% CI: 8.98, 68.92%; IQR = 0.3 ppm). There was no significant association between the rate of OHCA and air pollutants among women. One hundred seventy-four “fire-hours” (i.e., hours in which Melbourne’s air quality was affected by forest fire smoke) were identified during 12 days of the 2006/2007 fire season, and 23.9 (95% CI: 3.1, 40.2) excess OHCAs were estimated to occur due to elevations in PM2.5 during these fire-hours. Conclusions This study found an association between exposure to forest fire smoke and an increase in the rate of OHCA. These findings have implications for public health messages to raise

  19. The search for a spin crossover transition in small sized π-conjugated molecules: a Monte Carlo study.

    PubMed

    Bhattacharya, S; Ferreira, M S; Sanvito, S

    2011-08-10

    The spin crossover transition in π-conjugated polymers is a complex phenomenon involving a balance between Coulomb interaction and collective lattice distortions. We explore such a transition with a minimal electronic model comprising a Hubbard-U on-site repulsive potential and both electron-phonon and hyperfine interactions. The model is then solved numerically for small molecules at finite temperature by Monte Carlo methods in the search for the spin crossover. This is done at the mean field level in the Hubbard-U interaction at half filling. We demonstrate that for a certain region of the parameter space there is a spin crossover, where the system transits from a low-spin to a high-spin state as the temperature increases. In close analogy to standard spin crossover in divalent magnetic molecules such a transition is entropy driven, with both the spin and the vibrational contributions to the entropy being relevant. Such a transition is practically unaffected by the hyperfine interaction, which only plays a minor role in determining the electronic properties.

  20. The search for a spin crossover transition in small sized π-conjugated molecules: a Monte Carlo study

    NASA Astrophysics Data System (ADS)

    Bhattacharya, S.; Ferreira, M. S.; Sanvito, S.

    2011-08-01

    The spin crossover transition in π-conjugated polymers is a complex phenomenon involving a balance between Coulomb interaction and collective lattice distortions. We explore such a transition with a minimal electronic model comprising a Hubbard-U on-site repulsive potential and both electron-phonon and hyperfine interactions. The model is then solved numerically for small molecules at finite temperature by Monte Carlo methods in the search for the spin crossover. This is done at the mean field level in the Hubbard-U interaction at half filling. We demonstrate that for a certain region of the parameter space there is a spin crossover, where the system transits from a low-spin to a high-spin state as the temperature increases. In close analogy to standard spin crossover in divalent magnetic molecules such a transition is entropy driven, with both the spin and the vibrational contributions to the entropy being relevant. Such a transition is practically unaffected by the hyperfine interaction, which only plays a minor role in determining the electronic properties.

  1. An Exploratory Crossover Study of Learner Perceptions of Use of Audio in Multimedia-Based Tutorials

    ERIC Educational Resources Information Center

    Yu, Chong Ho; Jannasch-Pennell, Angel; DiGangi, Samuel; Kaprolet, Charles

    2009-01-01

    While multimedia-based training is prevalent in education, previous studies do not reach consensus on its application. This discrepancy might be due to the fact that multimedia programs implemented in various training programs are very diverse. A multimedia program might include graphics, animation, video, audio, and interactive exercises. This…

  2. Crossover of Phonological Processing Skills: A Study of Spanish-Speaking Students in Two Instructional Settings

    ERIC Educational Resources Information Center

    Leafstedt, Jill M.; Gerber, Michael M.

    2005-01-01

    This study investigated three questions: Do phonological processes show cross-linguistic transfer? How does the language of instruction influence the relationship between phonological processes and decoding? Does performance on Spanish and English phonological processing tasks similarly predict English decoding for the same English learners (ELs)?…

  3. Emergency room visits for acute gastrointestinal illness following flooding: A case-crossover study

    EPA Science Inventory

    Climate change may alter the frequency of precipitation and flooding which can increase fecal-oral transmission of acute gastrointestinal illness (AGI) through contact with contaminated items or water. Few studies have quantified the risk associated with flood events in the Unite...

  4. Clomipramine vs desipramine vs placebo in the treatment of diabetic neuropathy symptoms. A double-blind cross-over study.

    PubMed Central

    Sindrup, S H; Gram, L F; Skjold, T; Grodum, E; Brøsen, K; Beck-Nielsen, H

    1990-01-01

    1. The effect of clomipramine and desipramine on diabetic neuropathy symptoms was examined in a double-blind, randomised, placebo controlled, cross-over study for 2 + 2 + 2 weeks. Drug doses were adjusted according to the sparteine phenotype, i.e. extensive metabolisers were treated with 75 mg clomipramine day-1 and 200 mg desipramine day-1 whereas poor metabolisers were treated with 50 mg day-1 of both drugs. Nineteen patients completed the study. 2. Plasma concentration of clomipramine plus desmethylclomipramine was 70-510 nM in extensive metabolisers, vs 590 and 750 nM in two poor metabolisers. Desipramine levels were 130-910 nM, vs 860 and 880 nM. 3. Both clomipramine and desipramine significantly reduced the symptoms of neuropathy as measured by observer- and self rating in comparison with placebo. Clomipramine tended to be more efficacious than desipramine. Patients with a weak or absent response on clomipramine had lower plasma concentrations (clomipramine plus desmethyl-clomipramine less than 200 nM) than patients with a better response. For desipramine a relationship between plasma concentration and effect was not established. 4. Side effect ratings did not differ for clomipramine and desipramine and on both drugs three patients withdrew due to side effects. 5. Compared with earlier results obtained with imipramine dosed on the basis of plasma level monitoring, clomipramine and desipramine on fixed doses appeared less efficacious whereas the side effect profiles were the same. At least for clomipramine, appropriate dose adjustment on the basis of plasma level monitoring may increase the efficacy. PMID:2271367

  5. Postabsorption concentration peaks with brand-name and generic verapamil: a double-blind, crossover study in elderly hypertensive patients.

    PubMed

    Saseen, J J; Porter, J A; Barnette, D J; Bauman, J L; Zajac, E J; Carter, B L

    1997-06-01

    The pharmacokinetic actions, bioequivalence, and cardiovascular effects of two verapamil products were studied in a randomized, double-blind, crossover study in eight elderly hypertensive patients (median age, 69.5 years; range, 60-79 years) given brand-name or generic immediate-release verapamil in 120-mg twice-daily doses for 14 days. Blood pressures, heart rates, P-R intervals; and serum concentrations of R-/S-verapamil and norverapamil were measured multiple times in patients during the last day of each therapy. Median blood pressure decreased more with generic verapamil than with the brand-name drug, with the largest difference occurring at 0.5 hours (137/74 mmHg versus 144.5/80.5 mmHg; P = 0.05 and 0.091, respectively). Pharmacokinetic parameters were not different for the two products (P < 0.01). However, the generic product, compared with the brand-name drug, had mean area under the concentration-time curve (time 0 to 12 hours) ratios (90% CI) of 1.09 (0.78-1.52), 1.16 (0.87-1.55) and 1.11 (0.81-1.52) for R-, S-, and total verapamil. Seventy concentration peaks (31 with the brand-name drug, 39 with the generic drug) appeared between 8 and 24 hours. Median percentages of increase of these peaks, compared with those of previous concentrations, were 48.3% and 36.3% for brand-name and generic drugs, respectively. Fifty of the 70 peaks (71%) were associated with a stereospecific concentration peak of norverapamil and, temporally, with meals. Our findings suggest that whereas the two verapamil products may not be bioequivalent by Food and Drug Administration criteria, the observed differences in effects were not clinically significant in this elderly population. Multiple concentration peaks after absorption were observed in all patients with both verapamil products and were perhaps related to enterohepatic recirculation.

  6. Red ginseng relieves the effects of alcohol consumption and hangover symptoms in healthy men: a randomized crossover study.

    PubMed

    Lee, Mi-Hyang; Kwak, Jung Hyun; Jeon, Gayoung; Lee, Jong-Won; Seo, Jang-Ho; Lee, Hoon-Sang; Lee, Jong Ho

    2014-03-01

    Heavy drinking causes hangover symptoms, because the action of alcohol dehydrogenase forms acetaldehyde, which is metabolized by acetaldehyde dehydrogenase into acetate. Red ginseng shows positive effects on alcohol metabolism in animal studies. We investigated the effects of red ginseng on relieving alcohol and hangover symptoms in 25 healthy men in a randomized crossover study. At each visit (0, 1, and 2 weeks), the subjects drank 100 mL whiskey (40% alcohol) and either 100 mL water or 100 mL of a 0.321 mg mL(-1) red ginseng anti-hangover drink (RGD). We took blood samples periodically until 240 min after alcohol consumption, and we investigated the blood profiles, alcohol levels, and acetaldehyde levels. We also measured anthropometric parameters, expiratory air-alcohol levels, and hangover symptoms. The plasma alcohol concentrations within the RGD group were significantly lower than those within the placebo group after 30 min (p = 0.002), 45 min (p = 0.016), and 60 min (p = 0.009); the areas under the response curves revealed a positive effect of RGD (p = 0.051). Furthermore, the expiratory alcohol concentration was significantly lower after 30 min (p = 0.005) and 60 min (p = 0.065), and the areas under the response curves (p = 0.058) likewise revealed a positive effect of RGD. The plasma acetaldehyde level was significantly elevated at 120 min (p = 0.020), but the areas under the response curves showed a similar trend (p = 0.054). While the plasma acetaldehyde concentration slightly increased, the RGD showed positive effects on hangover symptoms. Considering the reduction of plasma alcohol levels, expiratory concentrations, and hangover severity, we conclude that red ginseng relieves the symptoms of alcohol hangover.

  7. Effect of combined treatment with immunoadsorption and membrane filtration on plasma coagulation--Results of a randomized controlled crossover study.

    PubMed

    Biesenbach, Peter; Eskandary, Farsad; Ay, Cihan; Wiegele, Marion; Derfler, Kurt; Schaden, Eva; Haslacher, Helmuth; Oberbauer, Rainer; Böhmig, Georg A

    2016-02-01

    The combined use of immunoadsorption (IA) and membrane filtration (MF) may markedly enhance removal of IgM and complement component C1q, supporting its use as an element of recipient desensitization in antibody-incompatible transplantation. However, coagulation factor removal may contribute to altered hemostasis, posing a risk of bleeding in the perioperative setting. This secondary endpoint analysis of standard coagulation assays and rotational thromboelastometry (ROTEM®) was performed in the context of a randomized controlled crossover study designed to assess the effect of combined IA (GAM-146-peptide) and MF on levels of ABO antigen-specific IgM. Fourteen patients with autoimmune disorders were randomized to a single treatment with IA+MF followed by IA alone, or vice versa. MF was found to markedly enhance fibrinogen depletion (57% vs. 28% median decrease after IA alone, P < 0.001), whereby four patients showed post-treatment fibrinogen concentrations below 100 mg dL(-1). In support of a critical contribution of fibrinogen depletion to impaired coagulation, extrinsically activated ROTEM(®) analysis revealed a marked reduction in fibrinogen-dependent clot formation upon IA+MF (59% median decrease in FIBTEM mean clot firmness (MCF) as compared to 24% after IA alone, P < 0.001). Moreover, the addition of MF led to a substantial prolongation of activated partial thromboplastin time, possibly due to depletion of macromolecular coagulation factors contributing to intrinsically activated coagulation. Our study demonstrates substantial effects of combined IA+MF on clot formation, which may be mainly attributable to fibrinogen depletion. We suggest that the use of combined apheresis in the setting of transplant surgery may necessitate a careful monitoring of coagulation.

  8. Alcohol quantity and type on risk of recurrent gout attacks: An internet-based case-crossover study

    PubMed Central

    Neogi, Tuhina; Chen, Clara; Niu, Jingbo; Chaisson, Christine; Hunter, David J.; Zhang, Yuqing

    2014-01-01

    Objectives Although beer and liquor have been associated with risk of incident gout, wine has not. Yet anecdotally, wine is thought to trigger gout attacks. Further, how much alcohol intake is needed to increase the risk of gout attack is not known. We examined the quantity and type of alcohol consumed on risk of recurrent gout attacks. Methods We conducted a prospective internet-based case-crossover study in the United States among participants with gout and who had at least one attack during the one year of follow-up. We evaluated the association of alcohol intake over the prior 24 hours as well as the type of alcoholic beverage with risk of recurrent gout attack, adjusting for potential time-varying confounders. Results This study included 724 participants with gout (78% men, mean age 54 years). There was a significant dose-response relationship between amount of alcohol consumption and risk of recurrent gout attacks (p<0.001 for trend). The risk of recurrent gout attack was 1.36 (95% CI: 1.00 to 1.88) and 1.51 (95% CI: 1.09 to 2.09) times higher for >1–2 and >2–4 alcoholic beverages, respectively, compared with no alcohol consumption in the prior 24 hours. Consuming wine, beer, or liquor, was each associated with an increased risk of gout attack. Conclusions Episodic alcohol consumption, regardless of type of alcoholic beverage, was associated with an increased risk of recurrent gout attacks, including potentially with moderate amounts. Persons with gout should limit alcohol intake of all types to reduce the risk of recurrent gout attacks. PMID:24440541

  9. A randomised, double- blind, cross-over study investigating the prebiotic effect of agave fructans in healthy human subjects.

    PubMed

    Ramnani, P; Costabile, A; Bustillo, A G R; Gibson, G R

    2015-01-01

    This placebo-controlled, randomised, double-blind, cross-over human feeding study aimed to determine the prebiotic effect of agave fructans. A total of thirty-eight volunteers completed this trial. The treatment consisted of 3 weeks' supplementation with 5 g/d of prebiotic agave fructan (Predilife) or equivalent placebo (maltodextrin), followed by a 2-week washout period following which subjects were crossed over to alternate the treatment arm for 3 weeks followed by a 2-week washout. Faecal samples were collected at baseline, on the last day of treatment (days 22 and 58) and washout (days 36 and 72), respectively. Changes in faecal bacterial populations, SCFA and secretory IgA were assessed using fluorescent in situ hybridisation, GC and ELISA, respectively. Bowel movements, stool consistencies, abdominal comfort and mood changes were evaluated by a recorded daily questionnaire. In parallel, the effect of agave fructans on different regions of the colon using a three-stage continuous culture simulator was studied. Predilife significantly increased faecal bifidobacteria (log10 9·6 (sd 0·4)) and lactobacilli (log10 7·7 (sd 0·8)) compared with placebo (log10 9·2 (sd 0·4); P = 0·00) (log10 7·4 (sd 0·7); P = 0·000), respectively. No change was observed for other bacterial groups tested, SCFA, secretory IgA, and PGE2 concentrations between the treatment and placebo. Denaturing gradient gel electrophoresis analysis indicated that bacterial communities were randomly dispersed and no significant differences were observed between Predilife and placebo treatments. The in vitro models showed similar increases in bifidobacterial and lactobacilli populations to that observed with the in vivo trial. To conclude, agave fructans are well tolerated in healthy human subjects and increased bifidobacteria and lactobacilli numbers in vitro and in vivo but did not influence other products of fermentation. PMID:26090092

  10. A randomised, crossover study on an electronic vapour product, a nicotine inhalator and a conventional cigarette. Part A: Pharmacokinetics.

    PubMed

    Walele, Tanvir; Sharma, Girish; Savioz, Rebecca; Martin, Claire; Williams, Josie

    2016-02-01

    The pharmacokinetic (PK) profile of nicotine delivered by an Electronic Vapour Product (EVP) was characterised in a 2-part study in smokers. The study was designed as a randomised, controlled, four-way crossover trial. Part 1 compared an unflavoured e-liquid (UF2.0%) and a flavoured e-liquid (FL2.0%) to a conventional cigarette (CC; JPS Silver King Size, 0.6 mg) and a licensed nicotine inhalator (Nicorette(®); 15 mg). Part 2 compared e-liquids with increasing nicotine concentrations (0%, 0.4%, 0.9%, 2.0%). Subjects used each different product for a daily use session. In Part 1, maximum plasma nicotine concentration (Cmax) for UF2.0%, FL2.0%, Nicorette(®) and CC was 3.6, 2.5, 2.5 and 21.2 ng/mL, respectively. The time to maximum plasma nicotine concentration (Tmax) was longer for the EVP (UF2.0%, 9.0 min; FL2.0%, 10.0 min) and the nicotine inhalator (13.0 min) compared to CC (3.0 min). In Part 2, EVP with 0%, 0.4%, 0.9% and 2.0% nicotine produced Cmax values of 0.6, 1.0, 1.9 and 3.6 ng/mL, respectively. At the maximum nicotine concentration of 2% as prescribed by the European Tobacco Directive, the EVP achieved nicotine delivery that was comparable to the inhalator. EVPs thus offer a potential alternative to nicotine inhalator devices for those finding it difficult to quit smoking.

  11. Carotenoids are more bioavailable from papaya than from tomato and carrot in humans: a randomised cross-over study

    PubMed Central

    Schweiggert, Ralf M.; Kopec, Rachel E.; Villalobos-Gutierrez, Maria G.; Högel, Josef; Quesada, Silvia; Esquivel, Patricia; Schwartz, Steven J.; Carle, Reinhold

    2014-01-01

    Carrot, tomato and papaya represent important dietary sources of β-carotene and lycopene. The main objective of the present study was to compare the bioavailability of carotenoids from these food sources in healthy human subjects. A total of sixteen participants were recruited for a randomised cross-over study. Test meals containing raw carrots, tomatoes and papayas were adjusted to deliver an equal amount of β-carotene and lycopene. For the evaluation of bioavailability, TAG-rich lipoprotein (TRL) fractions containing newly absorbed carotenoids were analysed over 9.5 h after test meal consumption. The bioavailability of β-carotene from papayas was approximately three times higher than that from carrots and tomatoes, whereas differences in the bioavailability of β-carotene from carrots and tomatoes were insignificant. Retinyl esters appeared in the TRL fractions at a significantly higher concentration after the consumption of the papaya test meal. Similarly, lycopene was approximately 2.6 times more bioavailable from papayas than from tomatoes. Furthermore, the bioavailability of β-cryptoxanthin from papayas was shown to be 2.9 and 2.3 times higher than that of the other papaya carotenoids β-carotene and lycopene, respectively. The morphology of chromoplasts and the physical deposition form of carotenoids were hypothesised to play a major role in the differences observed in the bioavailability of carotenoids from the foods investigated. Particularly, the liquid-crystalline deposition of β-carotene and the storage of lycopene in very small crystalloids in papayas were found to be associated with their high bioavailability. In conclusion, papaya was shown to provide highly bioavailable β-carotene, β-cryptoxanthin and lycopene and may represent a readily available dietary source of provitamin A for reducing the incidence of vitamin A deficiencies in many subtropical and tropical developing countries. PMID:23931131

  12. Air Pollution and Subtypes, Severity and Vulnerability to Ischemic Stroke—A Population Based Case-Crossover Study

    PubMed Central

    Maheswaran, Ravi; Pearson, Tim; Beevers, Sean D.; Campbell, Michael J.; Wolfe, Charles D.

    2016-01-01

    Background and Purpose Few studies have examined the association between air pollutants and ischemic stroke subtypes. We examined acute effects of outdoor air pollutants (PM10, NO2, O3, CO, SO2) on subtypes and severity of incident ischemic stroke and investigated if pre-existing risk factors increased susceptibility. Methods We used a time stratified case-crossover study and stroke cases from the South London Stroke Register set up to capture all incident cases of first ever stroke occurring amongst residents in a geographically defined area. The Oxford clinical and TOAST etiological classifications were used to classify subtypes. A pragmatic clinical classification system was used to assess severity. Air pollution concentrations from the nearest background air pollution monitoring stations to patients’ residential postcode centroids were used. Lags from 0 to 6 days were investigated. Results There were 2590 incident cases of ischemic stroke (1995–2006). While there were associations at various lag times with several pollutants, overall, there was no consistent pattern between exposure and risk of ischemic stroke subtypes or severity. The possible exception was the association between NO2 exposure and small vessel disease stroke—adjusted odds ratio of 1.51 (1.12–2.02) associated with an inter-quartile range increase in the lag 0–6 day average for NO2. There were no clear associations in relation to pre-existing risk factors. Conclusions Overall, we found little consistent evidence of association between air pollutants and ischemic stroke subtypes and severity. There was however a suggestion that increasing NO2 exposure might be associated with higher risk of stroke caused by cerebrovascular small vessel disease. PMID:27362783

  13. Red ginseng relieves the effects of alcohol consumption and hangover symptoms in healthy men: a randomized crossover study.

    PubMed

    Lee, Mi-Hyang; Kwak, Jung Hyun; Jeon, Gayoung; Lee, Jong-Won; Seo, Jang-Ho; Lee, Hoon-Sang; Lee, Jong Ho

    2014-03-01

    Heavy drinking causes hangover symptoms, because the action of alcohol dehydrogenase forms acetaldehyde, which is metabolized by acetaldehyde dehydrogenase into acetate. Red ginseng shows positive effects on alcohol metabolism in animal studies. We investigated the effects of red ginseng on relieving alcohol and hangover symptoms in 25 healthy men in a randomized crossover study. At each visit (0, 1, and 2 weeks), the subjects drank 100 mL whiskey (40% alcohol) and either 100 mL water or 100 mL of a 0.321 mg mL(-1) red ginseng anti-hangover drink (RGD). We took blood samples periodically until 240 min after alcohol consumption, and we investigated the blood profiles, alcohol levels, and acetaldehyde levels. We also measured anthropometric parameters, expiratory air-alcohol levels, and hangover symptoms. The plasma alcohol concentrations within the RGD group were significantly lower than those within the placebo group after 30 min (p = 0.002), 45 min (p = 0.016), and 60 min (p = 0.009); the areas under the response curves revealed a positive effect of RGD (p = 0.051). Furthermore, the expiratory alcohol concentration was significantly lower after 30 min (p = 0.005) and 60 min (p = 0.065), and the areas under the response curves (p = 0.058) likewise revealed a positive effect of RGD. The plasma acetaldehyde level was significantly elevated at 120 min (p = 0.020), but the areas under the response curves showed a similar trend (p = 0.054). While the plasma acetaldehyde concentration slightly increased, the RGD showed positive effects on hangover symptoms. Considering the reduction of plasma alcohol levels, expiratory concentrations, and hangover severity, we conclude that red ginseng relieves the symptoms of alcohol hangover. PMID:24458173

  14. Topical Effect of a Medically Prescribed Pediatric Antibiotic on Dental Biofilm: A Cross-Over, In Situ Study

    PubMed Central

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

    2013-01-01

    Objective This study aimed to investigate the possible topical effect of a broad-spectrum antibiotic on dental biofilm formed in situ in the absence or presence of sucrose. Methods A crossover study was conducted in three phases of 14 days each, during which 11 volunteers wore palatal devices containing 6 enamel blocks covered with meshes to allow biofilm formation. Dental blocks were extraorally submitted to a 20% sucrose solution at three different frequencies of exposure (0, 3 and 8 times/day), and to a suspension of amoxicillin/clavulanate potassium (A/CP) or a placebo (P) suspension at an 8-hour time interval application regimen. On the 14th day of each phase, biofilms were collected for microbiological (conventional culture) and molecular (Denaturing Gradient Gel Electrophoresis – DGGE) analyses. Results In the absence of sucrose exposure (SE) and at the 3-time daily frequency, dental biofilms treated with A/CP showed lower total biofilm weight and lower counts of total microbiota than the ones treated with P (p>0.05). A/CP presented higher counts of Candida spp. when compared with P in the presence of SE, especially at the 8-time daily frequency (p<0.05). Considering the DGGE analysis, the mean number of bands was higher for P (p>0.05), regardless of SE. However, DGGE profiles demonstrated large interindividual variability. Conclusion Both conventional culture and DGGE have demonstrated some differences on total microbiota of dental biofilms when exposed to the A/CP or P suspensions, mainly in the absence of sucrose, which suggests a possible topical effect of the sugar-free A/CP suspension on dental biofilm. PMID:23383224

  15. Is Zolpidem Associated with Increased Risk of Fractures in the Elderly with Sleep Disorders? A Nationwide Case Cross-Over Study in Taiwan

    PubMed Central

    Chu, Fang-Ying; Chen, Hung-An; Yin, Yun-Ju; Lee, Hua-Chin; Chu, William Cheng-Chung; Yeh, Hui-Wen; Chiang, Wei-Shan; Yeh, Chia-Lun; Huang, Hui-Ling; Tzeng, Nian-Sheng

    2015-01-01

    Background We conducted a study using a case-crossover design to clarify the risk of acute effects of zolpidem and benzodiazepine on all-sites of fractures in the elderly. Design of study Case-crossover design. Methods and Materials Elderly enrollees (n = 6010) in Taiwan’s National Health Insurance Research Database with zolpidem or benzodiazepine use were analyzed for the risk of developing fractures. Results After adjusting for medications such as antipsychotics, antidepressants, and diuretics, or comorbidities such as hypertension, osteoarthritis, osteoporosis, rheumatoid arthritis and depression, neither zolpidem nor benzodiazepine was found to be associated with increased risk in all-sites fractures. Subjects without depression were found to have an increased risk of fractures. Diazepam is the only benzodiazepine with increased risk of fractures after adjusting for medications and comorbidities. Hip and spine were particular sites for increased fracture risk, but following adjustment for comorbidities, the associations were found to be insignificant. Conclusion Neither zolpidem nor benzodiazepine was associated with increased risk of all-site fractures in this case cross-over study after adjusting for medications or comorbidities in elderly individuals with insomnia. Clinicians should balance the benefits and risks for prescribing zolpidem or benzodiazepine in the elderly accordingly. PMID:26716836

  16. Comparison of Minimalist Footwear Strategies for Simulating Barefoot Running: A Randomized Crossover Study

    PubMed Central

    Hollander, Karsten; Argubi-Wollesen, Andreas; Reer, Rüdiger; Zech, Astrid

    2015-01-01

    Possible benefits of barefoot running have been widely discussed in recent years. Uncertainty exists about which footwear strategy adequately simulates barefoot running kinematics. The objective of this study was to investigate the effects of athletic footwear with different minimalist strategies on running kinematics. Thirty-five distance runners (22 males, 13 females, 27.9 ± 6.2 years, 179.2 ± 8.4 cm, 73.4 ± 12.1 kg, 24.9 ± 10.9 km.week-1) performed a treadmill protocol at three running velocities (2.22, 2.78 and 3.33 m.s-1) using four footwear conditions: barefoot, uncushioned minimalist shoes, cushioned minimalist shoes, and standard running shoes. 3D kinematic analysis was performed to determine ankle and knee angles at initial foot-ground contact, rate of rear-foot strikes, stride frequency and step length. Ankle angle at foot strike, step length and stride frequency were significantly influenced by footwear conditions (p<0.001) at all running velocities. Posthoc pairwise comparisons showed significant differences (p<0.001) between running barefoot and all shod situations as well as between the uncushioned minimalistic shoe and both cushioned shoe conditions. The rate of rear-foot strikes was lowest during barefoot running (58.6% at 3.33 m.s-1), followed by running with uncushioned minimalist shoes (62.9%), cushioned minimalist (88.6%) and standard shoes (94.3%). Aside from showing the influence of shod conditions on running kinematics, this study helps to elucidate differences between footwear marked as minimalist shoes and their ability to mimic barefoot running adequately. These findings have implications on the use of footwear applied in future research debating the topic of barefoot or minimalist shoe running. PMID:26011042

  17. Comparison of minimalist footwear strategies for simulating barefoot running: a randomized crossover study.

    PubMed

    Hollander, Karsten; Argubi-Wollesen, Andreas; Reer, Rüdiger; Zech, Astrid

    2015-01-01

    Possible benefits of barefoot running have been widely discussed in recent years. Uncertainty exists about which footwear strategy adequately simulates barefoot running kinematics. The objective of this study was to investigate the effects of athletic footwear with different minimalist strategies on running kinematics. Thirty-five distance runners (22 males, 13 females, 27.9 ± 6.2 years, 179.2 ± 8.4 cm, 73.4 ± 12.1 kg, 24.9 ± 10.9 km x week(-1)) performed a treadmill protocol at three running velocities (2.22, 2.78 and 3.33 m x s(-1)) using four footwear conditions: barefoot, uncushioned minimalist shoes, cushioned minimalist shoes, and standard running shoes. 3D kinematic analysis was performed to determine ankle and knee angles at initial foot-ground contact, rate of rear-foot strikes, stride frequency and step length. Ankle angle at foot strike, step length and stride frequency were significantly influenced by footwear conditions (p<0.001) at all running velocities. Posthoc pairwise comparisons showed significant differences (p<0.001) between running barefoot and all shod situations as well as between the uncushioned minimalistic shoe and both cushioned shoe conditions. The rate of rear-foot strikes was lowest during barefoot running (58.6% at 3.33 m x s(-1)), followed by running with uncushioned minimalist shoes (62.9%), cushioned minimalist (88.6%) and standard shoes (94.3%). Aside from showing the influence of shod conditions on running kinematics, this study helps to elucidate differences between footwear marked as minimalist shoes and their ability to mimic barefoot running adequately. These findings have implications on the use of footwear applied in future research debating the topic of barefoot or minimalist shoe running.

  18. Comparison of three different prehospital wrapping methods for preventing hypothermia - a crossover study in humans

    PubMed Central

    2011-01-01

    Background Accidental hypothermia increases mortality and morbidity in trauma patients. Various methods for insulating and wrapping hypothermic patients are used worldwide. The aim of this study was to compare the thermal insulating effects and comfort of bubble wrap, ambulance blankets / quilts, and Hibler's method, a low-cost method combining a plastic outer layer with an insulating layer. Methods Eight volunteers were dressed in moistened clothing, exposed to a cold and windy environment then wrapped using one of the three different insulation methods in random order on three different days. They were rested quietly on their back for 60 minutes in a cold climatic chamber. Skin temperature, rectal temperature, oxygen consumption were measured, and metabolic heat production was calculated. A questionnaire was used for a subjective evaluation of comfort, thermal sensation, and shivering. Results Skin temperature was significantly higher 15 minutes after wrapping using Hibler's method compared with wrapping with ambulance blankets / quilts or bubble wrap. There were no differences in core temperature between the three insulating methods. The subjects reported more shivering, they felt colder, were more uncomfortable, and had an increased heat production when using bubble wrap compared with the other two methods. Hibler's method was the volunteers preferred method for preventing hypothermia. Bubble wrap was the least effective insulating method, and seemed to require significantly higher heat production to compensate for increased heat loss. Conclusions This study demonstrated that a combination of vapour tight layer and an additional dry insulating layer (Hibler's method) is the most efficient wrapping method to prevent heat loss, as shown by increased skin temperatures, lower metabolic rate and better thermal comfort. This should then be the method of choice when wrapping a wet patient at risk of developing hypothermia in prehospital environments. PMID:21699720

  19. A randomized, controlled, crossover study in patients with mild and moderate asthma undergoing treatment with traditional Chinese acupuncture

    PubMed Central

    Pai, Hong Jin; Azevedo, Raymundo Soares; Braga, Alfésio Luís Ferreira; Martins, Lourdes Conceição; Saraiva-Romanholo, Beatriz M; de Arruda Martins, Milton; Lin, Chin An

    2015-01-01

    OBJECTIVES: This study sought to verify the effects of acupuncture as an adjuvant treatment for the control of asthma. METHODS: This was a randomized, controlled, crossover trial conducted at the Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo. A total of 74 patients with mild/moderate, persistent asthma were randomized into two therapeutic groups: Group A – 31 patients underwent 10 real weekly acupuncture sessions, followed by a 3-week washout period and 10 sham weekly acupuncture sessions; and Group B - 43 patients underwent 10 sham weekly acupuncture sessions, followed by a 3-week washout period and 10 real weekly acupuncture sessions. Patients used short- and long-acting β-2 agonists and inhaled corticosteroids when necessary. Prior to treatment and after each period of 10 treatment sessions, the patients were evaluated for spirometry, induced sputum cell count, exhaled nitric oxide (NO) and with the Short Form 36 (SF-36) and Questionnaire on Quality of Life-Asthma (QQLA) questionnaires. Daily peak flow and symptom diaries were registered. The level of significance adopted was 5% (α=0.05). RESULTS: In Group B, after real acupuncture, there was a decrease in eosinophils (p=0.035) and neutrophils (p=0.047), an increase in macrophages (p=0.001) and an improvement in peak flow (p=0.01). After sham acupuncture treatment, patients experienced less coughing (p=0.037), wheezing (p=0.013) and dyspnea (p=0.014); similarly, after real acupuncture, patients reported less coughing (p=0.040), wheezing (p=0.012), dyspnea (p<0.001) and nocturnal awakening episodes (p=0.009). In Group A, there was less use of rescue medication (p=0.043). After the sham procedure, patients in Group A experienced less coughing (p=0.007), wheezing (p=0.037), dyspnea (p<0.001) and use of rescue medication (p<0.001) and after real acupuncture, these patients showed improvements in functional capacity (p=0.004), physical aspects (p=0.002), general health status (p<0

  20. Etodolac versus diclofenac: double-blind cross-over study in rheumatoid arthritis.

    PubMed

    Ciompi, M L; Puccetti, L; Bazzichi, L; Remorini, E; Marotta, G

    1989-01-01

    A 14-day double-blind clinical study was conducted on 16 patients with clinically active rheumatoid arthritis to compare the effects of etodolac (600 mg daily) and diclofenac (150 mg daily). Admission criteria were: functional impairment between Steinbrocker's classes I to III, Ritchie's index greater than 10 and erythrocyte sedimentation rate greater than 25 mm/h, and finally active involvement of the small joints of the hands. Following a wash-out period of at least two days from their previous non-steroidal anti-inflammatory drugs, trial patients received etodolac or diclofenac for five consecutive days by random allocation; after that, and after another two day wash-out period, all patients were crossed-over to the alternate drug for another five consecutive days. One day before intake and on the last day of each treatment lap, each patient was examined in regard to the circadian grip strength (of the more severely affected hand), Ritchie's index and acute phase reactants; at the end of the second treatment period, subjective drug preference was explored. Grip strength was assessed by the patients themselves with a dynamometer at 08h00 and every two hours thereafter until 20h00. The overall daily value was calculated by measuring the area under curve (AUC) depicting the grip strength profile. Both groups of patients showed significant improvement of the Ritchie's index (p less than 0.01) and grip strength AUC (p less than 0.05), while taking medication, whereas no significant variations were noted in regard to the values of the acute phase parameters both between the two treatment groups, and within each treatment group. At termination, four patients expressed preference for etodolac, eight were in favour of diclofenac, and four gave an indifferent judgement. No statistically significant differences were detected between the two treatment groups; also no adverse events were seen in this short-term study. The results confirm the effectiveness and tolerability of

  1. Effect of hypoxic training on inflammatory and metabolic risk factors: a crossover study in healthy subjects

    PubMed Central

    Shi, Bateer; Watanabe, Tsuneo; Shin, Sohee; Yabumoto, Tamotsu; Takemura, Masao; Matsuoka, Toshio

    2014-01-01

    Abstract The purpose of this study was to investigate the influence of hypoxic physical exercise on metabolic syndrome (MS) risk markers and high‐sensitivity C‐reactive protein (CRP) and to compare its effects on preperitoneal fat, arterial stiffness, and several blood parameters related to MS to those of a control group who trained under normoxic conditions. Fourteen healthy men were examined. Participants performed treadmill exercise 3 days per week for 4 weeks, under either normobaric hypoxic or normobaric normoxic conditions, for 50 min (including a 5‐min warm‐up and 5‐min cool down) after a 30‐min rest period. Exercise was performed at a heart rate (HR) corresponding to 60% of the HR at each individual's maximum oxygen uptake. Training under the different environmental conditions was performed 4 months apart to ensure a sufficient washout period. Waist circumference, preperitoneal fat thickness, brachial‐ankle pulse wave velocity, and high‐sensitivity CRP after training were significantly lower in the hypoxic group than in the normoxic group. Our results suggest that regular short‐term hypoxic training may more effectively reduce arterial stiffness, and thus prevent arteriosclerosis, compared to training performed at a similar exercise intensity under normoxic conditions. PMID:24744877

  2. Randomized cross-over clinical trial to study potential pharmacokinetic interactions between cisplatin or carboplatin and etoposide

    PubMed Central

    Thomas, Huw D; Porter, David J; Bartelink, Imke; Nobbs, Joy R; Cole, Michael; Elliott, Suzie; Newell, David R; Calvert, A Hilary; Highley, Martin; Boddy, Alan V

    2002-01-01

    Aims Cisplatin and carboplatin are often used in combination with etoposide. In a randomized cross-over study, the potential interaction between the two platinum drugs and the metabolism of etoposide was explored. In vitro investigations using human liver microsomes were also performed. Methods Etoposide was administered to 15 patients over 3 days, with the platinum drug administered on day 2. The alternate platinum drug was administered on the second course. The pharmacokinetics of etoposide were determined on all 3 days of each cycle. The effect of platinum drugs on etoposide metabolism by human liver enzymes was explored in vitro. Results Neither cisplatin nor carboplatin coadministration affected the pharmacokinetics of etoposide during cycle 1. When carboplatin was administered on course 2, etoposide AUC was 8% higher on day 2 compared with day 1 or day 3 (for day 2 vs day 3, 95% CI: −0.72, −0.08 mg ml−1 min). In contrast, cisplatin on course 2 increased the AUC of etoposide (28%) on day 3 (day 3 vs day 1, 95% CI: 0.67, 2.09 mg ml−1 min), with no effect on day 2. In vitro carboplatin and cisplatin (10–100 µm) inhibited the metabolism of etoposide, if rat liver microsomes were preincubated (30 min) with NADPH and the platinum complexes. With human liver microsomes a small effect on etoposide metabolism, but not on catechol formation, was observed. Conclusions The interaction between etoposide and platinum drugs is small and, given the pharmacokinetic variability seen with etoposide, the clinical impact is unlikely to be significant. PMID:11849199

  3. A High Protein Diet Has No Harmful Effects: A One-Year Crossover Study in Resistance-Trained Males

    PubMed Central

    Ellerbroek, Anya; Silver, Tobin; Vargas, Leonel; Tamayo, Armando; Buehn, Richard

    2016-01-01

    The purpose of this investigation was to determine the effects of a high protein diet over a one-year period. Fourteen healthy resistance-trained men completed the study (mean ± SD; age 26.3 ± 3.9 yr; height 178.5 ± 8.4 cm; and average years of training 8.9 ± 3.4 yr). In a randomized crossover design, subjects consumed their habitual or normal diet for 2 months and 4 months and alternated that with a higher protein diet (>3 g/kg/d) for 2 months and 4 months. Thus, on average, each subject was on their normal diet for 6 months and a higher protein diet for 6 months. Body composition was assessed via the Bod Pod®. Each subject provided approximately 100–168 daily dietary self-reports. During the subjects' normal eating phase, they consumed (mean ± SD) 29.94 ± 5.65 kcals/kg/day and 2.51 ± 0.69 g/kg/day of protein. This significantly increased (p < 0.05) during the high protein phase to 34.37 ± 5.88 kcals/kg/day and 3.32 ± 0.87 g/kg/day of protein. Our investigation discovered that, in resistance-trained men that consumed a high protein diet (~2.51–3.32 g/kg/d) for one year, there were no harmful effects on measures of blood lipids as well as liver and kidney function. In addition, despite the total increase in energy intake during the high protein phase, subjects did not experience an increase in fat mass. PMID:27807480

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

    PubMed Central

    2012-01-01

    Background Around the world, beans and rice are commonly consumed together as a meal. With type 2 diabetes increasing, the effect of this traditional diet pattern on glycemic response has not been studied fully. Methods We evaluated the glycemic response of bean and rice traditional meals compared to rice alone in adults with type 2 diabetes. Seventeen men and women with type 2 diabetes controlled by metformin (n = 14) or diet/exercise (n = 3) aged 35–70 years participated in the randomized 4 × 4 crossover trial. The white long grain rice control, pinto beans/rice, black beans/rice, red kidney beans/rice test meals, matched for 50 grams of available carbohydrate, were consumed at breakfast after a 12 hour fast. Capillary blood glucose concentrations at baseline and at 30 minute intervals up to 180 minutes postprandial were collected. MANOVA for repeated measures established glucose differences between treatments. Paired t tests identified differences between bean types and the rice control following a significant MANOVA. Results Postprandial net glucose values were significantly lower for the three bean/rice treatments in contrast to the rice control at 90, 120 and 150 minutes. Incremental area under the curve values were significantly lower for the pinto and black bean/rice meals compared to rice alone, but not for kidney beans. Conclusions Pinto, dark red kidney and black beans with rice attenuate the glycemic response compared to rice alone. Promotion of traditional foods may provide non-pharmaceutical management of type 2 diabetes and improve dietary adherence with cultural groups. Trial registration Clinical Trials number NCT01241253 PMID:22494488

  5. Air Pollution and Acute Myocardial Infarction Hospital Admission in Alberta, Canada: A Three-Step Procedure Case-Crossover Study.

    PubMed

    Wang, Xiaoming; Kindzierski, Warren; Kaul, Padma

    2015-01-01

    Adverse associations between air pollution and myocardial infarction (MI) are widely reported in medical literature. However, inconsistency and sensitivity of the findings are still big concerns. An exploratory investigation was undertaken to examine associations between air pollutants and risk of acute MI (AMI) hospitalization in Alberta, Canada. A time stratified case-crossover design was used to assess the transient effect of five air pollutants (carbon monoxide (CO), nitrogen dioxide (NO2), nitric oxide (NO), ozone (O3) and particulate matter with an aerodynamic diameter ≤2.5 (PM2.5)) on the risk of AMI hospitalization over the period 1999-2009. Subgroups were predefined to see if any susceptible group of individuals existed. A three-step procedure, including univariate analysis, multivariate analysis, and bootstrap model averaging, was used. The multivariate analysis was used in an effort to address adjustment uncertainty; whereas the bootstrap technique was used as a way to account for regression model uncertainty. There were 25,894 AMI hospital admissions during the 11-year period. Estimating health effects that are properly adjusted for all possible confounding factors and accounting for model uncertainty are important for making interpretations of air pollution-health effect associations. The most robust findings included: (1) only 1-day lag NO2 concentrations (6-, 12- or 24-hour average), but not those of CO, NO, O3 or PM2.5, were associated with an elevated risk of AMI hospitalization; (2) evidence was suggested for an effect of elevated risk of hospitalization for NSTEMI (Non-ST Segment Elevation Myocardial Infarction), but not for STEMI (ST segment elevation myocardial infarction); and (3) susceptible subgroups included elders (age ≥65) and elders with hypertension. As this was only an exploratory study there is a need to replicate these findings with other methodologies and datasets.

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

    PubMed

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

    2015-02-14

    Dairy products are rich sources of an array of fatty acids (FA) that have been shown individually and in certain clusters to exert varying effects on cardiovascular health, for which the circulating lipid profile is a powerful biomarker. Whether the profile of these FA is reflected in blood upon short terms of intake, possibly contributing to the lipid-related health impacts of dairy products, remains to be fully established. The objectives of the present study were to assess a recommended dairy product consumption in relation to circulating FA and lipid profiles, and to evaluate certain FA in dairy fat as potential biomarkers of intake. In a free-living, multi-centre, cross-over design, 124 healthy individuals consumed 3 servings/d of commercial dairy (DAIRY; 1% fat milk, 1·5% fat yogurt and 34% fat cheese) or energy-equivalent control (CONTROL; fruit and vegetable juice, cashews and a cookie) products for 4 weeks each, separated by a 4-week washout period. Plasma FA and serum lipid profiles were assessed by standard methods at the end of each dietary phase. After 4 weeks of intake, plasma levels of FA pentadecanoic acid (15 : 0) and heptadecanoic acid (17 : 0) were higher (0·26 v. 0·22% and 0·42 v. 0·39% of the total identified FA, respectively) after the DAIRY phase than after the CONTROL phase (P< 0·0001). This was accompanied by a small but significant increase in serum LDL-cholesterol levels after the DAIRY phase compared with the CONTROL phase (+0·08 mmol/l; P= 0·04). In conclusion, intake of 3 servings/d of conventional dairy products may modify certain circulating FA and lipid profiles within 4 weeks, where 15 : 0 and 17 : 0 may be potential short-term biomarkers of intake.

  7. Air Pollution and Emergency Department Visits for Otitis Media: A Case-Crossover Study in Edmonton, Canada

    PubMed Central

    Zemek, Roger; Szyszkowicz, Mieczysław; Rowe, Brian H.

    2010-01-01

    Background Otitis media (OM) is one of the most common early childhood infections, resulting in an enormous economic burden to the health care system through unscheduled doctor visits and antibiotic prescriptions. Objectives The objective of this study was to investigate the potential association between ambient air pollution exposure and emergency department (ED) visits for OM. Materials and Methods Ten years of ED data were obtained from Edmonton, Alberta, Canada, and linked to levels of air pollution: carbon monoxide (CO), nitrogen dioxide (NO2), ozone (O3), sulfur dioxide, and particulate matter (PM) of median aerometric diameter ≤ 10 and 2.5 μm (PM10 and PM2.5 respectively). A time-stratified case-crossover technique was applied to analyze the associations between ambient air pollution and health outcomes. Conditional logistic regression analysis with the subject’s identification number as a stratum variable was used to obtain odds ratios (ORs) and their corresponding 95% confidence intervals after adjustment for meteorological factors. Results We based the analysis on 14,527 ED visits for OM over 10 years in children 1–3 years of age. We observed statistically significant positive associations between ED visits for OM and interquartile increases in CO and NO2 levels after adjusting for ambient temperature and relative humidity. We observed the strongest associations (expressed by ORs) in the warmer months (April–September) in girls and all patients for exposure to CO and NO2, and in boys for exposure to CO, for 2 days before an OM ED visit. Conclusions These results support the hypothesis that ED visits for OM are associated with ambient air pollution. PMID:20663739

  8. A randomised cross-over cohort study of exposure to emissions from a road tunnel ventilation stack

    PubMed Central

    Cowie, Christine T; Ezz, Wafaa; Xuan, Wei; Lilley, William; Rose, Nectarios; Rae, Michael; Marks, Guy B

    2012-01-01

    Background and objective Road tunnels are increasingly important components of urban infrastructure. However, knowledge of their health impact on surrounding communities is limited. Our objective was to estimate the short-term respiratory health effects of exposure to emissions from a road tunnel ventilation stack. Methods We conducted a randomised cross-over cohort study in 36 volunteers who underwent three exposure scenarios in 2006 before the road tunnel opened, and in 2007 (n=27) and 2008 (n=20) after the tunnel opened. Exposure downwind of the stack was compared to upwind of the stack and to a distant heavily trafficked location adjacent to a main road. Spirometry, exhaled nitric oxide (eNO) and symptom scores were measured repeatedly during each 2 h exposure session. Results Downwind locations were associated with increased reports of ‘dry nose’ (score difference 0.36; 95% CI 0.09 to 0.63) compared with the control location (2006 vs 2007/2008), but not with impaired lung function, increased airway inflammation or other symptoms. The heavily trafficked location was associated with significantly increased eNO (ratio=1.09; 95% CI 1.04 to 1.14), eye (score difference 0.05; 95% CI 0.01 to 0.10) and chest (score difference 0.21; 95% CI 0.09 to 0.33) symptoms compared to the stack locations. Conclusions There was no consistent evidence of adverse respiratory effects from short-term exposures downwind of the tunnel ventilation stack, except for dry nose symptoms. However, the findings of increased airway inflammation and symptoms in subjects after only 2 h exposure at the heavily trafficked location, are suggestive of detrimental effects of short-term exposures to traffic-related air pollution. PMID:22904331

  9. A case-crossover study of transient risk factors for occupational acute hand injury

    PubMed Central

    Sorock, G; Lombardi, D; Hauser, R; Eisen, E; Herrick, R; Mittleman, M

    2004-01-01

    Background: Workers with acute hand injuries account for over 1 000 000 emergency department visits annually in the United States. Aims: To determine potential transient risk factors for occupational acute hand injury. Methods: Subjects were recruited from 23 occupational health clinics in five northeastern states in the USA. In a telephone interview, subjects were asked to report the occurrence of seven potential risk factors within a 90-minute time period before an acute hand injury. Each case also provided control information on exposures during the month before the injury. The self-matched feature of the study design controlled for stable between-person confounders. Results: A total of 1166 subjects were interviewed (891 men, 275 women), with a mean age (SD) of 37.2 years (11.4). The median time interval between injury and interview was 1.3 days. Sixty three per cent of subjects had a laceration. The relative risk of a hand injury was increased when working with equipment, tools, or work pieces not performing as expected (11.0, 95% CI 9.4 to 12.8), or when using a different work method to do a task (10.5, 95% CI 8.7 to 12.7). Other transient factors in decreasing order of relative risk were doing an unusual task, being distracted, and being rushed. Wearing gloves reduced the relative risk by 60% (0.4, 95% CI 0.3 to 0.5). Occupational category, job experience, and safety training were found to alter several of these effects. Conclusion: The results suggest the importance of these transient, potentially modifiable factors in the aetiology of acute hand injury at work. Attempts to modify these exposures by various strategies may reduce the incidence of acute hand injury at work. PMID:15031387

  10. Orally Formulated Artemisinin in Healthy Fasting Vietnamese Male Subjects: A Randomized, Four-Sequence, Open-Label, Pharmacokinetic Crossover Study

    PubMed Central

    Hien, Tran Tinh; Hanpithakpong, Warunee; Truong, Nguyen Thanh; Dung, Nguyen Thi; Toi, Pham Van; Farrar, Jeremy; Lindegardh, Niklas; Tarning, Joel; Ashton, Michael

    2011-01-01

    Background Artemisinin derivatives are used in antimalarial drug combination therapy. Artemisinin and piperaquine have recently been proven to be prospective candidates for combination therapy in the treatment of uncomplicated Plasmodium falciparum malaria. Objective The goal of this study was to evaluate the relative bioavailability and to characterize the pharmacokinetic properties of a new micronized powder formulation of artemisinin against the previous standard Vietnamese formulation when administered as a single oral dose or in combination with piperaquine. Methods This was a single-center, randomized, 4-sequence, open-label, crossover study conducted in 15 healthy male Vietnamese volunteers under fasting conditions with a washout period of 3 weeks between study visits. A single oral dose of 160 or 500 mg of artemisinin was administered alone or in combination with piperaquine. Potential adverse events were monitored daily by the clinician and by using laboratory test results. Frequent blood samples were drawn for 12 hours after dose. Artemisinin was quantified in plasma using LC-MS/MS. Pharmacokinetic parameters were computed from the plasma concentration–time profiles using a noncompartmental analysis method. Results Pharmacokinetic parameters Tmax, Cmax, AUC0-∞, Vd/F, CL/F, and t1/2 (mean [SD]) for the new formulation of artemisinin were 1.83 (0.88) hours, 178 (97) ng/mL, 504 (210) h × ng/mL, 1270 (780) L, 401 (260) L/h, and 2.21 (0.29) hours, respectively. The mean percentage of the test/reference formulation ratio for the logarithmically transformed values of Cmax, AUC0–last, and AUC0–∞ were 121% (90% CI, 92.5–158), 122% (90% CI, 101–148), and 120% (90% CI, 98.0–146), respectively. Conclusions This single-dose study found that the dose-normalized Cmax, AUC0–last, and AUC0–∞ mean geometric differences between the test and reference formulations were relatively small (<40%) and will probably not have a clinical impact in the

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

    PubMed Central

    Zobel, Isabelle; Erfani, Tahereh; Bennell, Kim L; Makovey, Joanna; Metcalf, Ben; March, Lyn; Zhang, Yuqing; Eckstein, Felix

    2016-01-01

    Background Knee osteoarthritis (OA) is one of the most frequent causes of limited mobility and diminished quality of life. Pain is the main symptom that drives individuals with knee OA to seek medical care and a recognized antecedent to disability and eventually joint replacement. Evidence shows that patients with symptomatic OA experience fluctuations in pain severity. Mechanical insults to the knee such as injury and buckling may contribute to pain exacerbation. Objective Our objective was to examine whether knee injury and buckling (giving way) are triggers for exacerbation of pain in persons with symptomatic knee OA. Methods We conducted a case-crossover study, a novel methodology in which participants with symptomatic radiographic knee OA who have had knee pain exacerbations were used as their own control (self-matched design), with all data collected via the Internet. Participants were asked to log-on to the study website and complete an online questionnaire at baseline and then at regular 10-day intervals for 3 months (control periods)—a total of 10 questionnaires. They were also instructed to go to the website and complete pain exacerbation questionnaires when they experienced an isolated incident of knee pain exacerbation (case periods). A pain exacerbation “case” period was defined as an increase of ≥2 compared to baseline. At each contact the pain exacerbation was designated a case period, and at all other regular 10-day contacts (control periods) participants were asked about knee injuries during the previous 7 days and knee buckling during the previous 2 days. The relationship of knee injury and buckling to the risk of pain exacerbation was examined using conditional logistic regression models. Results The analysis included 157 participants (66% women, mean age: 62 years, mean BMI: 29.5 kg/m2). Sustaining a knee injury was associated with experiencing a pain exacerbation (odds ratio [OR] 10.2, 95% CI 5.4, 19.3) compared with no injury. Knee

  12. Erratum to: Extracranial contamination in the INVOS 5100C versus the FORE-SIGHT ELITE cerebral oximeter: a prospective observational crossover study in volunteers.

    PubMed

    Greenberg, Steven; Murphy, Glenn; Shear, Torin; Patel, Aashka; Simpson, Andrew; Szokol, Joseph; Avram, Michael J; Vender, Jeffery

    2016-04-01

    In the article entitled: "Extracranial contamination in the INVOS 5100C versus the FORE-SIGHT ELITE cerebral oximeter: a prospective observational crossover study in volunteers" published in the January 2016 issue of theJournal, Can J Anesth 2016; 63: 24-30, in the second column of page 29, the second to last sentence of the first paragraph should read: "Another study by Sorenson et al. examined 15 healthy males under different physiologic conditions". The publisher apologizes most sincerely for this error.

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

    PubMed

    Assawawitoontip, Surin; Wiwanitkit, Viroj

    2002-06-01

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

  14. A controlled crossover human volunteer study of the in vivo filtration efficacy of a high-efficiency particulate air-filtering oxygen mask.

    PubMed

    Wai, Joey K M; Gomersall, Charles D

    2011-11-01

    Nosocomial airborne disease transmission can be important in some epidemics. An oxygen mask incorporating a high-efficiency particulate (HEPA) filter may reduce the chance of inhaling airborne particles. In a randomized controlled crossover volunteer study, the median ratio of ambient:intramask 0.02 to 1-μ particles was significantly higher for the HEPA oxygen mask than for a Hudson-type mask (P < .001), and was ≥100 in 59%-64% of subjects. The use of HEPA masks may protect patients receiving supplementary oxygen against airborne pathogens. PMID:21664003

  15. Subcutaneous versus intravenous administration of heparin in the treatment of deep vein thrombosis; which do patients prefer? A randomized cross-over study.

    PubMed

    Robinson, A M; McLean, K A; Greaves, M; Channer, K S

    1993-02-01

    Patient preference for intravenous or subcutaneous heparin in the treatment of deep venous thrombosis was assessed in a randomized cross-over study. Twenty patients with venographically proven deep venous thrombosis were randomized to receive subcutaneous or intravenous heparin for 3 days followed by 3 days of the other treatment. Discomfort at the injection site, assessed by visual analogue scale, was significantly less for the subcutaneous than the intravenous administration route (P < 0.001), mobility was thought to be better when receiving subcutaneous heparin (P < 0.005) and patients' overall preference was for subcutaneous treatment (P < 0.001). PMID:8506190

  16. A randomized cross-over study of inhalation of diesel exhaust, hematological indices, and endothelial markers in humans

    PubMed Central

    2013-01-01

    Background Exposure to traffic-related air pollution (TRAP) is considered a trigger for acute cardiovascular events. Diesel Exhaust (DE) is a major contributor to TRAP in the world. We evaluated the effect of DE inhalation on circulating blood cell populations, hematological indices, and systemic inflammatory cytokines in humans using a specialized facility. Methods In a randomized double-blind crossover study balanced to order, 17 metabolic syndrome (MetS) and 15 healthy subjects inhaled filtered air (FA) or DE exposure in two-hour sessions on different days with a minimum 2-week washout period. We collected blood pre-exposure, 7, and 22 hours after exposure initiation and measured the complete blood count and differential. We performed multiplex cytokine assay to measure the changes in the systemic inflammatory cytokines, and endothelial adhesion molecules (n=15). A paired analysis compared the effect of DE and FA exposures for the change from pre-exposure to the subsequent time points. Results A significant increase in the hematocrit was noted 7 hrs after DE [1.4% (95% CI: 0.9 to 1.9%)] compared to FA exposure [0.5% (95% CI: -0.09 to 1.0%); p=0.008. The hemoglobin levels increased non-significantly at 7 hrs post DE [0.3 gm/dL (95% CI: 0.2 to 0.5 gm/dL)] versus FA exposure [0.2 gm/dL (95% CI: 0 to 0.3 gm/dL)]; p=0.06. Furthermore, the platelet count increased 22 hrs after DE exposure in healthy, but not in MetS subjects [DE: 16.6 (95% CI: 10.2 to 23) thousand platelets/mL versus [FA: 3.4 (95% CI: -9.5 to 16.3) thousand platelets/mL)]; p=0.04. No DE effect was observed for WBC, neutrophils, lymphocytes or erythrocytes. Using the multiplex assay, small borderline significant increases in matrix metalloproteinase-9, interleukins (IL)-1beta, 6 and 10 occurred 7 hrs post exposure initiation, whereas E-selectin, intercellular adhesion molecule-1, and vascular cell adhesion molecule -1, and myeloperoxidase 22 hrs post exposure. Conclusions Our results suggest that short

  17. The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study

    PubMed Central

    Ahmed, Mansoor; Aamir, Rozina; Jishi, Zahra; Scharf, Martin B.

    2016-01-01

    Objective: This study examined the effects of milnacipran on polysomnographic (PSG) measures of sleep and subjective complaints in patients with fibromyalgia and disturbed sleep. Methods: This was a single-site, double-blind, placebo-controlled, two-period crossover PSG study. Eligible subjects (aged 28–72 y) were randomized (1:1) to milnacipran (100 mg/d) or placebo for crossover period 1, and vice versa for period 2. Each crossover period comprised a dose-escalation and dose-maintenance phase, with a 2-w taper/washout between periods. In-laboratory PSGs were collected at baseline, and at the end of each treatment period. The primary endpoints were the difference in PSG-recorded wake after sleep onset (WASO), number of awakenings after sleep onset (NAASO), and sleep efficiency (SE) between 4 w of maintenance treatment with milnacipran and placebo. Other PSG measures, subject-rated sleep, fatigue, physical functioning, and pain were assessed. Post hoc analysis was performed in subjects showing at least 25% reduction in pain from baseline in the Brief Pain Inventory Score (responders). Results: Of 19 subjects randomized, 15 completed both periods. Subjects treated with milnacipran showed no significant improvements in WASO and NAASO, but showed reduced SE (p = 0.049). Milnacipran did not show significant improvement in other PSG parameters or subjective endpoints. Two thirds of completers met responder criteria and additionally showed a significant improvement in daily effect of pain (p = 0.043) and subjective sleep quality (p = 0.040). Conclusion: The data suggest that milnacipran is not sedating in most patients with fibromyalgia and improvements in sleep are likely a result of pain improvement. Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT01234675 Citation: Ahmed M, Aamir R, Jishi Z, Scharf MB. The effects of milnacipran on sleep disturbance in fibromyalgia: a randomized, double-blind, placebo-controlled, two-way crossover study. J Clin Sleep

  18. Comparisons on Efficacy of Elcatonin and Limaprost Alfadex in Patients with Lumbar Spinal Stenosis and Concurrent Osteoporosis: A Preliminary Study Using a Crossover Design

    PubMed Central

    Imajo, Yasuaki; Suzuki, Hidenori; Yoshida, Yuichiro; Taguchi, Toshihiko; Tominaga, Toshikatsu; Toyoda, Koichiro

    2014-01-01

    Study Design Multicenter prospective study with a crossover design. Purpose The objective of this study is to compare the efficacy of limaprost alfadex (LP) and elcatonin (EL) for lumbar spinal stenosis (LSS) patients with concurrent osteoporosis. Overview of Literature It has been increasingly important to improve quality of life by establishing appropriate conservative treatments for LSS patients with concurrent osteoporosis who will presumably continue to increase due to the percentage of the aging elevations, however there is no prospective study. Methods A total of 19 patients with LSS and concurrent osteoporosis were enrolled in this study. The patients were divided into two groups and compared using a crossover design. The Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) and short-form (SF)-8 health survey scale were used for clinical evaluations. Results There was a significant improvement of buttock-leg pain and numbness in the EL group. A significant improvement of impaired walking function was noted for the LP group according to the JOABPEQ while the rest of the items in the JOABPEQ showed no significant differences. The SF-8 health survey revealed that somatic pains and physical summary scores in the EL group and physical functioning and physical summary scores in the LP group tended to improve but not to any statistically significant extents. Conclusions Concomitant uses of EL may be useful in patients who do not respond satisfactorily to the treatments of LP for 6-8 weeks. PMID:25187864

  19. Does heavy physical exertion trigger myocardial infarction? A case-crossover analysis nested in a population-based case-referent study.

    PubMed

    Hallqvist, J; Möller, J; Ahlbom, A; Diderichsen, F; Reuterwall, C; de Faire, U

    2000-03-01

    To study possible triggering of first events of acute myocardial infarction by heavy physical exertion, the authors conducted a case-crossover analysis (1993-1994) within a population-based case-referent study in Stockholm County, Sweden (the Stockholm Heart Epidemiology Program). Interviews were carried out with 699 myocardial infarction patients after onset of the disease. These cases represented 47 percent of all cases in the study base, and 70 percent of all nonfatal cases. The relative risk from vigorous exertion was 6.1 (95% confidence interval: 4.2, 9.0). The rate difference was 1.5 per million person-hours, and the attributable proportion was 5.7 percent. The risk was modified by physical fitness, with an increased risk being seen among sedentary subjects as in earlier studies, but the data also suggested a U-shaped association. In addition, the trigger effect was modified by socioeconomic status. Premonitory symptoms were common, and this implies risks of reverse causation bias and misclassification of case exposure information that require methodological consideration. Different techniques (the use of the usual-frequency type of control information, a pair-matched analysis, and a standard case-referent analysis) were applied to overcome the threat of misclassification of control exposure information. A case-crossover analysis in a random sample of healthy subjects resulted in a relative risk close to unity, as expected.

  20. [Gitadyl versus ibuprofen in patients with osteoarthrosis. The result of a double-blind, randomized cross-over study].

    PubMed

    Ryttig, K; Schlamowitz, P V; Warnøe, O; Wilstrup, F

    1991-08-12

    Thirty-five patients suffering from mild to moderate osteoarthrosis were treated with Gitadyl (a herbal medicine containing 110 mg fever few, 90 mg American aspen, and 60 mg milfoil) or ibuprofen (Ibumetin) for three plus three weeks in a double-blind, cross-over trial. The dosages of Gitadyl and ibuprofen were three tablets per day and 1,200 mg, respectively. Both treatments gave the same reductions in subjective symptoms (pain and walking ability). Gastrointestinal side effects were more frequent in patients treated with ibuprofen. It is concluded that Gitadyl is an alternative form of treatment for patients who do not want a conventional drug or who experience gastrointestinal side effects of NSAID even in low dosage.

  1. Quantum Monte Carlo Study of the Ground-State Properties of a Fermi Gas in the BCS-BEC Crossover

    SciTech Connect

    Giorgini, S.; Astrakharchik, G. E.; Boronat, J.; Casulleras, J.

    2006-11-07

    The ground-state properties of a two-component Fermi gas with attractive short-range interactions are calculated using the fixed-node diffusion Monte Carlo method. The interaction strength is varied over a wide range by tuning the value of the s-wave scattering length of the two-body potential. We calculate the ground-state energy per particle and we characterize the equation of state of the system. Off-diagonal long-range order is investigated through the asymptotic behavior of the two-body density matrix. The condensate fraction of pairs is calculated in the unitary limit and on both sides of the BCS-BEC crossover.

  2. Assessment of bitter taste of pharmaceuticals with multisensor system employing 3 way PLS regression.

    PubMed

    Rudnitskaya, Alisa; Kirsanov, Dmitry; Blinova, Yulia; Legin, Evgeny; Seleznev, Boris; Clapham, David; Ives, Robert S; Saunders, Kenneth A; Legin, Andrey

    2013-04-01

    The application of the potentiometric multisensor system (electronic tongue, ET) for quantification of the bitter taste of structurally diverse active pharmaceutical ingredients (API) is reported. The measurements were performed using a set of bitter substances that had been assessed by a professional human sensory panel and the in vivo rat brief access taste aversion (BATA) model to produce bitterness intensity scores for each substance at different concentrations. The set consisted of eight substances, both inorganic and organic - azelastine, caffeine, chlorhexidine, potassium nitrate, naratriptan, paracetamol, quinine, and sumatriptan. With the aim of enhancing the response of the sensors to the studied APIs, measurements were carried out at different pH levels ranging from 2 to 10, thus promoting ionization of the compounds. This experiment yielded a 3 way data array (samples×sensors×pH levels) from which 3wayPLS regression models were constructed with both human panel and rat model reference data. These models revealed that artificial assessment of bitter taste with ET in the chosen set of API's is possible with average relative errors of 16% in terms of human panel bitterness score and 25% in terms of inhibition values from in vivo rat model data. Furthermore, these 3wayPLS models were applied for prediction of the bitterness in blind test samples of a further set of API's. The results of the prediction were compared with the inhibition values obtained from the in vivo rat model. PMID:23498685

  3. Spin-crossover molecule based thermoelectric junction

    SciTech Connect

    Ghosh, Dibyajyoti; Parida, Prakash; Pati, Swapan K.

    2015-05-11

    Using ab-initio numerical methods, we explore the spin-dependent transport and thermoelectric properties of a spin-crossover molecule (i.e., iron complex of 2-(1H-pyrazol-1-yl)-6-(1H-tetrazole-5-yl)pyridine) based nano-junction. We demonstrate a large magnetoresistance, efficient conductance-switching, and spin-filter activity in this molecule-based two-terminal device. The spin-crossover process also modulates the thermoelectric entities. It can efficiently switch the magnitude as well as spin-polarization of the thermocurrent. We find that thermocurrent is changed by ∼4 orders of magnitude upon spin-crossover. Moreover, it also substantially affects the thermopower and consequently, the device shows extremely efficient spin-crossover magnetothermopower generation. Furthermore, by tuning the chemical potential of electrodes into a certain range, a pure spin-thermopower can be achieved for the high-spin state. Finally, the reasonably large values of figure-of-merit in the presence and absence of phonon demonstrate a large heat-to-voltage conversion efficiency of the device. We believe that our study will pave an alternative way of tuning the transport and thermoelectric properties through the spin-crossover process and can have potential applications in generation of spin-dependent current, information storage, and processing.

  4. Effects on Occupants of Enhanced Particle Filtration in a non-problem office environment: A Double-Blind Crossover Intervention Study

    SciTech Connect

    Mendell, M.J.; Fisk, W.J.; Petersen, M.; Hines, C.J.; Faulkner, D.; Deddens, J.A.; Dong, M.X.; Ruder, A.M.; Sullivan, D.; Boenigner, M.F.

    1998-06-15

    Workers in indoor environments often complain of symptoms, such as eye and nose irritation, headache, and fatigue, which improve away from work. Exposures causing such complaints, sometimes referred to as sick building syndrome, generally have not been identified. Evidence suggests these worker symptoms are related to chemical, microbiological, physical, and psychosocial exposures not well characterized by current methods. Most research in this area has involved cross-sectional studies, which are limited in their abilities to show causal connections. Experimental studies have also been conducted which, by changing one factor at a time to isolate its effects, can demonstrate benefits of an environmental intervention even before exposures or mechanisms are understood. This study was prompted by evidence that particulate contaminants may be related to acute occupant symptoms and discomfort. The objective was to assess, with a double-blind, double crossover intervention design, whether improved removal of small airborne particles by enhanced central filtration would reduce symptoms and discomfort.

  5. Analgesic activity of fixed dose combinations of paracetamol with diclofenac sodium and paracetamol with tramadol on different pain models in healthy volunteers - A randomized double blind crossover study

    PubMed Central

    Tripathi, Sachidanand; Shah, Rima; Sharma, D C

    2012-01-01

    Aim: To evaluate and compare the analgesic activity of fixed dose combinations (FDC) of Paracetamol with Diclofenac sodium and Paracetamol with Tramadol on different human pain models in healthy human volunteers. Materials and Methods: A randomized double blind crossover study was carried out in 30 healthy human volunteers using three pain models; cold-water stress test, radiant heat method, and BP cuff inflation method. The subjects were randomized into two groups of 15 each, group A received FDC of Paracetamol 500 mg with Diclofenac sodium 50 mg and group B was given a FDC of Paracetamol 375 mg and Tramadol 50 mg. All the volunteers were tested on three pain models. Observations for pain tolerance were recorded at baseline and at the interval of 30, 60, 120, and 180 minutes after drug administration. Crossover was done after a washout period of 7 days. The results of both the study periods were analyzed using an independent t-test. Results: Mean age of the participants was 23±1 years and the male:female ratio was 2:1. In the radiant heat method, paracetamol with tramadol combination treatment showed a significant increase in pain tolerance at 2 hours and 3 hours (P 0.028 and 0.055 respectively) compared to paracetamol with diclofenac combination. Other two pain models did not show any significant difference in the study groups. Conclusion: Paracetamol with tramadol combination was more effective than paracetamol with diclofenac sodium combination on the radiant heat model. In human pain models, there is an incomplete understanding of mechanisms and activated pathways are not precisely determined that needs further evaluation. PMID:23225925

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

    PubMed Central

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

    2013-01-01

    Background Botanicals represent an important and underexplored source of potential new therapies that may facilitate caloric restriction and thereby produce long-term weight loss. In particular, one promising botanical that may reduce food intake and body weight by affecting neuroendocrine pathways related to satiety is Garcinia cambogia (Garcinia cambogia Desr.)-derived (−)-hydroxycitric acid (HCA). Methods and Design The objective of this article is to describe the protocol of a clinical trial designed to directly test the effect that Garcinia cambogia-derived HCA has on food intake, satiety, weight loss, and oxidative stress levels, and to serve as a model for similar trials. A total of 48 healthy, overweight and obese individuals (body mass index; BMI range = 25.0 – 39.9) between the ages of 50 to 70 will participate in this double-blind, placebo-controlled, crossover study designed to examine the effects of two doses of Garcinia cambogia-derived HCA on food intake, satiety, weight loss, and oxidative stress levels. This trial will take place at the University of Florida (UF)’s Aging and Rehabilitation Research Center (ARRC) and UF Clinical Research Center (CRC). Food intake represents the primary outcome measure and is calculated based on the total calories consumed at breakfast, lunch, and dinner meals during each test meal day at the CRC. This study can be completed with far fewer subjects than a parallel design. Discussion Of the numerous botanical compounds, the compound Garcinia cambogia-derived HCA was selected for testing in the present study because of its potential to safely reduce food intake, body weight, and oxidative stress levels. We will review potential mechanisms of action and safety parameters throughout this clinical trial, which is registered at ClinicalTrials.gov under NCT01238887. Trial registration ClinicalTrials.gov (Identifier: NCT01238887). PMID:22088584

  7. Excited metastables electronic spin states in spin crossover compounds studies by atom-phonon coupling model: Gradual and two-step transition cases

    NASA Astrophysics Data System (ADS)

    Gindulescu, A.; Rotaru, A.; Linares, J.; Dimian, M.; Nasser, J.

    2010-05-01

    This contribution reports the study of metastable spin states in spin-crossover materials in the framework of the atom-phonon coupling model. Using this model for a linear chain we show theoretically for the first time that, even if the cooperativity is not strong enough to obtain hysteresis at high temperatures, metastable states exist at low temperatures for a high spin (HS) fraction of nHS=1. This gradual thermal transition featuring metastable states at low temperature has been observed experimentally by [Létard et al., J. Phys.: Conf. Ser. 21, 23 (2005)]. Moreover, for compounds showing a two-step thermal transition, we show that metastable states, corresponding to a HS fraction nHS=0.5, are present. This metastable states appear up to 50 K, fact that was observed by [Moussa et al., Phys. Rev. Lett. 94, 107205 (2005)] and [Matsumoto et al., J. Phys.: Conf. Ser. 148, 012029 (2009)].

  8. Pipamperone (Dipiperon, R3345) in troublesome mental retardates: a double-blind placebo controlled cross-over study with long-term follow-up.

    PubMed

    van Hemert, J C

    1975-10-01

    A 6-week double-blind cross-over study comparing pipamperone with placebo was conducted in 20 female mental retardates with behavioural disorders. The ages of the patients ranged between 22 and 42 years. After a 2-week washout period, patients were randomly allocated to either pipamperone or placebo treatment. The initial dosage of pipamperone was 40 mg b.i.d., which was gradually increased to 80 mg b.i.d. within 5 days. Patients were assessed using a ten-item rating scale before and after each week of treatment. For six of the ten items, patients showed a better response during the pipamperone than during the placebo period. When pre-trial scores were compared with those at the end of the trial, seven items had significantly improved with pipamperone. The nursing staff considered the patients more alert and amenable during pipamperone treatment.

  9. Diet quality improves for parents and children when almonds are incorporated into their daily diet: a randomized, crossover study.

    PubMed

    Burns, Alyssa M; Zitt, Michelle A; Rowe, Cassie C; Langkamp-Henken, Bobbi; Mai, Volker; Nieves, Carmelo; Ukhanova, Maria; Christman, Mary C; Dahl, Wendy J

    2016-01-01

    The health benefits of nuts may, in part, be due to the fiber that provides substrate for the maintenance of a healthy and diverse microbiota. We hypothesized that consuming almonds would benefit immune status through improving diet quality and modulation of microbiota composition in parents and their children, while improving gastrointestinal function. In a crossover trial, 29 parents (35 ± 0.6 years) and their children (n = 29; 4 ± 0.2 years; pairs) consumed 1.5 and 0.5 oz, respectively, of almonds and/or almond butter or control (no almonds) for 3 weeks followed by 4-week washouts. Parents completed daily questionnaires of stool frequency and compliance with nut intake. The Gastrointestinal Symptom Response Scale was administered weekly. Participants provided stools for microbiota analysis and saliva for secretory immunoglobulin A. Serum antioxidant/proinflammatory balance was determined in parents. From weekly dietary recalls (Automated Self-Administered 24-Hour Dietary Recall), nutrient and energy intake were assessed and Healthy Eating Index-2010 scores were calculated. Consuming almonds increased total Healthy Eating Index score from 53.7 ± 1.8 to 61.4 ± 1.4 (parents) and 53.7 ± 2.6 to 61.4 ± 2.2 (children; P < .001). Minimal changes in gastrointestinal symptoms and no change in stool frequency were noted with the almond intervention. Microbiota was stable at the phylum and family level, but genus-level changes occurred with nut intake, especially in children. No differences were observed for immune markers. Although higher intakes of almonds or longer interventions may be needed to demonstrate effects on immune status, a moderate intake of almonds improves diet quality in adults and their young children and modulates microbiota composition.

  10. Work-related psychosocial events as triggers of sick leave - results from a Swedish case-crossover study

    PubMed Central

    2011-01-01

    Background Although illness is an important cause of sick leave, it has also been suggested that non-medical risk factors may influence this association. If such factors impact on the period of decision making, they should be considered as triggers. Yet, there is no empirical support available. The aim was to investigate whether recent exposure to work-related psychosocial events can trigger the decision to report sick when ill. Methods A case-crossover design was applied to 546 sick-leave spells, extracted from a Swedish cohort of 1 430 employees with a 3-12 month follow-up of new sick-leave spells. Exposure in a case period corresponding to an induction period of one or two days was compared with exposure during control periods sampled from workdays during a two-week period prior to sick leave for the same individual. This was done according to the matched-pair interval and the usual frequency approaches. Results are presented as odds ratios (OR) with 95% confidence intervals (CI). Results Most sick-leave spells happened in relation to acute, minor illnesses that substantially reduced work ability. The risk of taking sick leave was increased when individuals had recently been exposed to problems in their relationship with a superior (OR 3.63; CI 1.44-9.14) or colleagues (OR 4.68; CI 1.43-15.29). Individuals were also more inclined to report sick on days when they expected a very stressful work situation than on a day when they were not under such stress (OR 2.27; CI 1.40-3.70). Conclusions Exposure to problems in workplace relationships or a stressful work situation seems to be able to trigger reporting sick. Psychosocial work-environmental factors appear to have a short-term effect on individuals when deciding to report sick. PMID:21429193

  11. Comparison of deferral rates using a computerized versus written blood donor questionnaire: a randomized, cross-over study [ISRCTN84429599

    PubMed Central

    Sellors, John W; Hayward, Robert; Swanson, Graham; Ali, Anita; Haynes, R Brian; Bourque, Ronald; Moore, Karen-Ann; Lohfeld, Lynne; Dalby, Dawn; Howard, Michelle

    2002-01-01

    Background Self-administered computer-assisted blood donor screening strategies may elicit more accurate responses and improve the screening process. Methods Randomized crossover trial comparing responses to questions on a computerized hand-held tool (HealthQuiz, or HQ), to responses on the standard written instrument (Donor Health Assessment Questionnaire, or DHAQ). Randomly selected donors at 133 blood donation clinics in the area of Hamilton, Canada participated from 1995 to 1996. Donors were randomized to complete either the HQ or the DHAQ first, followed by the other instrument. In addition to responses of 'yes' and 'no' on both questionnaires, the HQ provided a response option of 'not sure'. The primary outcome was the number of additional donors deferred by the HQ. Results A total of 1239 donors participated. Seventy-one potential donors were deferred as a result of responses to the questionnaires; 56.3% (40/71) were deferred by the DHAQ, and an additional 43.7% (31/71) were deferred due to risks identified by the HQ but not by the DHAQ. Fourteen donors self-deferred; 11 indicated on the HQ that they should not donate blood on that day but did not use the confidential self-exclusion option on the DHAQ, and three used the self-exclusion option on the DHAQ but did not indicate that they should not donate blood on the HQ. The HQ identified a blood contact or risk factor for HIV/AIDS or sexually transmitted infection that was not identified by the DHAQ in 0.1% to 2.7% of donors. Conclusion A self-administered computerized questionnaire may increase risk reporting by blood donors. PMID:12191432

  12. EP3/FP dual receptor agonist ONO-9054 administered morning or evening to patients with open-angle glaucoma or ocular hypertension: results of a randomised crossover study

    PubMed Central

    Berlin, Michael S; Rowe-Rendleman, Cheryl; Ahmed, Ike; Ross, Douglas T; Fujii, Akifumi; Ouchi, Takafumi; Quach, Christine; Wood, Andrew; Ward, Caroline L

    2016-01-01

    Background/aims The novel prostaglandin E (EP) 3 and prostaglandin F (FP) receptor agonist ONO-9054 is effective in lowering intraocular pressure (IOP) in patients with ocular hypertension and open-angle glaucoma when administered once daily. This study compares the effects of morning (AM) versus evening (PM) dosing of ONO-9054 on tolerability and IOP lowering. Methods This was a single-centre, randomised, double-masked, two-sequence, placebo-controlled crossover study in 12 subjects with bilateral primary open-angle glaucoma or ocular hypertension. Two 14-day crossover regimens were separated by a 2-week washout: ONO-9054 (1 drop to each eye) in the morning (07:00) and vehicle in the evening (19:00) and vice versa. IOP was measured multiple times during select days. Ocular examinations also evaluated safety and tolerability. Results Mild ocular hyperaemia, reported by six subjects with PM dosing, was the most frequent adverse event. Mild to moderate dryness was also slightly more frequent after PM dosing. Maximum IOP reduction from baseline occurred on day 2 with decreases from baseline of −7.4 mm Hg (−30.8%) for AM dosing and −9.1 mm Hg, (−38.0%) for PM dosing; after 14 days, mean reduction in IOP was −6.8 mm Hg (−28.6%) for AM dosing and −7.5 mm Hg (−31.0%) for PM dosing. Conclusions PM dosing of ONO-0954 was associated with a slightly increased frequency of mild hyperaemia and mild to moderate dryness. Both dosing schedules provided sustained reduction in IOP. Trial registration number NCT01670266. PMID:26453641

  13. Impact of palm date consumption on microbiota growth and large intestinal health: a randomised, controlled, cross-over, human intervention study.

    PubMed

    Eid, Noura; Osmanova, Hristina; Natchez, Cecile; Walton, Gemma; Costabile, Adele; Gibson, Glenn; Rowland, Ian; Spencer, Jeremy P E

    2015-10-28

    The reported inverse association between the intake of plant-based foods and a reduction in the prevalence of colorectal cancer may be partly mediated by interactions between insoluble fibre and (poly)phenols and the intestinal microbiota. In the present study, we assessed the impact of palm date consumption, rich in both polyphenols and fibre, on the growth of colonic microbiota and markers of colon cancer risk in a randomised, controlled, cross-over human intervention study. A total of twenty-two healthy human volunteers were randomly assigned to either a control group (maltodextrin-dextrose, 37·1 g) or an intervention group (seven dates, approximately 50 g). Each arm was of 21 d duration and was separated by a 14-d washout period in a cross-over manner. Changes in the growth of microbiota were assessed by fluorescence in situ hybridisation analysis, whereas SCFA levels were assessed using HPLC. Further, ammonia concentrations, faecal water genotoxicity and anti-proliferation ability were also assessed using different assays, which included cell work and the Comet assay. Accordingly, dietary intakes, anthropometric measurements and bowel movement assessment were also carried out. Although the consumption of dates did not induce significant changes in the growth of select bacterial groups or SCFA, there were significant increases in bowel movements and stool frequency (P<0·01; n 21) and significant reductions in stool ammonia concentration (P<0·05; n 21) after consumption of dates, relative to baseline. Furthermore, date fruit intake significantly reduced genotoxicity in human faecal water relative to control (P<0·01; n 21). Our data indicate that consumption of date fruit may reduce colon cancer risk without inducing changes in the microbiota.

  14. Impact of palm date consumption on microbiota growth and large intestinal health: a randomised, controlled, cross-over, human intervention study.

    PubMed

    Eid, Noura; Osmanova, Hristina; Natchez, Cecile; Walton, Gemma; Costabile, Adele; Gibson, Glenn; Rowland, Ian; Spencer, Jeremy P E

    2015-10-28

    The reported inverse association between the intake of plant-based foods and a reduction in the prevalence of colorectal cancer may be partly mediated by interactions between insoluble fibre and (poly)phenols and the intestinal microbiota. In the present study, we assessed the impact of palm date consumption, rich in both polyphenols and fibre, on the growth of colonic microbiota and markers of colon cancer risk in a randomised, controlled, cross-over human intervention study. A total of twenty-two healthy human volunteers were randomly assigned to either a control group (maltodextrin-dextrose, 37·1 g) or an intervention group (seven dates, approximately 50 g). Each arm was of 21 d duration and was separated by a 14-d washout period in a cross-over manner. Changes in the growth of microbiota were assessed by fluorescence in situ hybridisation analysis, whereas SCFA levels were assessed using HPLC. Further, ammonia concentrations, faecal water genotoxicity and anti-proliferation ability were also assessed using different assays, which included cell work and the Comet assay. Accordingly, dietary intakes, anthropometric measurements and bowel movement assessment were also carried out. Although the consumption of dates did not induce significant changes in the growth of select bacterial groups or SCFA, there were significant increases in bowel movements and stool frequency (P<0·01; n 21) and significant reductions in stool ammonia concentration (P<0·05; n 21) after consumption of dates, relative to baseline. Furthermore, date fruit intake significantly reduced genotoxicity in human faecal water relative to control (P<0·01; n 21). Our data indicate that consumption of date fruit may reduce colon cancer risk without inducing changes in the microbiota. PMID:26428278

  15. Experimental study of crossover from capillary to viscous fingering for supercritical CO2 - water displacement in a homogeneous pore network

    SciTech Connect

    Wang, Ying; Zhang, Changyong; Wei, Ning; Oostrom, Martinus; Wietsma, Thomas W.; Li, Xiaochun; Bonneville, Alain

    2012-06-05

    Carbon sequestration in saline aquifers involves displacing resident brine from the pore space by supercritical CO2 (scCO2 ). The displacement process is considered unstable due to the unfavorable viscosity ratio (logM < 0). The unstable mechanisms that affect scCO2 - water displacement under reservoir conditions (i.e., 41 °C, 9 MPa) were investigated in a homogeneous micromodel. A wide range of injection rates (logCa = -7.61~-4.73) was studied in two sets of experiments: discontinuous-rate injection, where the micromodel was first cleaned and saturated with water before each injection rate was imposed, and continuous-rate injection, where the rate was increased after quasi-steady conditions were reached for a certain rate. For the discontinuous-rate experiments, capillary fingering and viscous fingering are the dominant mechanisms for low (logCa <= -6.61) and high injection rates (logCa >= -5.21), respectively. Crossover from capillary to viscous fingering was observed for logCa = -5.91~-5.21, resulting in a large decrease in scCO2 saturation. The discontinuous-rate experimental results confirmed the decrease in nonwetting fluid saturation during crossover from capillary to viscous fingering predicted by numerical simulations by Lenormand et al. (1988).1 Capillary fingering was the only mechanism that dominates all injection rates in the continuous-rate experiment, and resulted in monotonic increase in scCO2 saturation.

  16. Crossover ensembles of random matrices and skew-orthogonal polynomials

    SciTech Connect

    Kumar, Santosh; Pandey, Akhilesh

    2011-08-15

    Highlights: > We study crossover ensembles of Jacobi family of random matrices. > We consider correlations for orthogonal-unitary and symplectic-unitary crossovers. > We use the method of skew-orthogonal polynomials and quaternion determinants. > We prove universality of spectral correlations in crossover ensembles. > We discuss applications to quantum conductance and communication theory problems. - Abstract: In a recent paper (S. Kumar, A. Pandey, Phys. Rev. E, 79, 2009, p. 026211) we considered Jacobi family (including Laguerre and Gaussian cases) of random matrix ensembles and reported exact solutions of crossover problems involving time-reversal symmetry breaking. In the present paper we give details of the work. We start with Dyson's Brownian motion description of random matrix ensembles and obtain universal hierarchic relations among the unfolded correlation functions. For arbitrary dimensions we derive the joint probability density (jpd) of eigenvalues for all transitions leading to unitary ensembles as equilibrium ensembles. We focus on the orthogonal-unitary and symplectic-unitary crossovers and give generic expressions for jpd of eigenvalues, two-point kernels and n-level correlation functions. This involves generalization of the theory of skew-orthogonal polynomials to crossover ensembles. We also consider crossovers in the circular ensembles to show the generality of our method. In the large dimensionality limit, correlations in spectra with arbitrary initial density are shown to be universal when expressed in terms of a rescaled symmetry breaking parameter. Applications of our crossover results to communication theory and quantum conductance problems are also briefly discussed.

  17. Altered Crossover Distribution and Frequency in Spermatocytes of Infertile Men with Azoospermia.

    PubMed

    Ren, He; Ferguson, Kyle; Kirkpatrick, Gordon; Vinning, Tanya; Chow, Victor; Ma, Sai

    2016-01-01

    During meiosis, homologous chromosomes pair to facilitate the exchange of DNA at crossover sites along the chromosomes. The frequency and distribution of crossover formation are tightly regulated to ensure the proper progression of meiosis. Using immunofluorescence techniques, our group and others have studied the meiotic proteins in spermatocytes of infertile men, showing that this population displays a reduced frequency of crossovers compared to fertile men. An insufficient number of crossovers is thought to promote chromosome missegregation, in which case the faulty cell may face meiotic arrest or contribute to the production of aneuploid sperm. Increasing evidence in model organisms has suggested that the distribution of crossovers may also be important for proper chromosome segregation. In normal males, crossovers are shown to be rare near centromeres and telomeres, while frequent in subtelomeric regions. Our study aims to characterize the crossover distribution in infertile men with non-obstructive (NOA) and obstructive azoospermia (OA) along chromosomes 13, 18 and 21. Eight of the 16 NOA men and five of the 21 OA men in our study displayed reduced crossover frequency compared to control fertile men. Seven NOA men and nine OA men showed altered crossover distributions on at least one of the chromosome arms studied compared to controls. We found that although both NOA and OA men displayed altered crossover distributions, NOA men may be at a higher risk of suffering both altered crossover frequencies and distributions compared to OA men. Our data also suggests that infertile men display an increase in crossover formation in regions where they are normally inhibited, specifically near centromeres and telomeres. Finally, we demonstrated a decrease in crossovers near subtelomeres, as well as increased average crossover distance to telomeres in infertile men. As telomere-guided mechanisms are speculated to play a role in crossover formation in subtelomeres, future

  18. Altered Crossover Distribution and Frequency in Spermatocytes of Infertile Men with Azoospermia

    PubMed Central

    Ren, He; Ferguson, Kyle; Kirkpatrick, Gordon; Vinning, Tanya; Chow, Victor; Ma, Sai

    2016-01-01

    During meiosis, homologous chromosomes pair to facilitate the exchange of DNA at crossover sites along the chromosomes. The frequency and distribution of crossover formation are tightly regulated to ensure the proper progression of meiosis. Using immunofluorescence techniques, our group and others have studied the meiotic proteins in spermatocytes of infertile men, showing that this population displays a reduced frequency of crossovers compared to fertile men. An insufficient number of crossovers is thought to promote chromosome missegregation, in which case the faulty cell may face meiotic arrest or contribute to the production of aneuploid sperm. Increasing evidence in model organisms has suggested that the distribution of crossovers may also be important for proper chromosome segregation. In normal males, crossovers are shown to be rare near centromeres and telomeres, while frequent in subtelomeric regions. Our study aims to characterize the crossover distribution in infertile men with non-obstructive (NOA) and obstructive azoospermia (OA) along chromosomes 13, 18 and 21. Eight of the 16 NOA men and five of the 21 OA men in our study displayed reduced crossover frequency compared to control fertile men. Seven NOA men and nine OA men showed altered crossover distributions on at least one of the chromosome arms studied compared to controls. We found that although both NOA and OA men displayed altered crossover distributions, NOA men may be at a higher risk of suffering both altered crossover frequencies and distributions compared to OA men. Our data also suggests that infertile men display an increase in crossover formation in regions where they are normally inhibited, specifically near centromeres and telomeres. Finally, we demonstrated a decrease in crossovers near subtelomeres, as well as increased average crossover distance to telomeres in infertile men. As telomere-guided mechanisms are speculated to play a role in crossover formation in subtelomeres, future

  19. 3 Ways.

    ERIC Educational Resources Information Center

    Hale, Hanna S.; And Others

    1982-01-01

    Describes three art activities for the Christmas holidays. Upper-elementary art classes create a life-size Santa's workshop decorated with paper-mache gingerbread cookies. Kindergarten children draw the king and queen of Christmas. Elementary and secondary students decorate store windows for holidays and community celebrations. (AM)

  20. MS-Electronic Nose Performance Improvement Using GC Retention Times And 2-Way And 3-Way Data Processing Methods

    SciTech Connect

    Burian, Cosmin; Llobet, Eduard; Vilanova, Xavier; Canellas, Nicolau; Brezmes, Jesus; Vinaixa, Maria; Correig, Xavier

    2009-05-23

    We have designed a challenging experimental sample set in the form of 20 solutions with a high degree of similarity in order to study whether the addition of chromatographic separation information improves the performance of regular MS based electronic noses. In order to make an initial study of the approach, two different chromatographic methods were used. By processing the data of these experiments with 2 and 3-way algorithms, we have shown that the addition of chromatographic separation information improves the results compared to the 2-way analysis of mass spectra or total ion chromatogram treated separately. Our findings show that when the chromatographic peaks are resolved (longer measurement times), 2-way methods work better than 3-way methods, whereas in the case of a more challenging measurement (more coeluted chromatograms, much faster GC-MS measurements) 3-way methods work better.

  1. What's Mine Is Yours: The Crossover of Day-Specific Self-Esteem

    ERIC Educational Resources Information Center

    Neff, Angela; Sonnentag, Sabine; Niessen, Cornelia; Unger, Dana

    2012-01-01

    This diary study examines the daily crossover of self-esteem within working couples. By integrating self-esteem research into the crossover framework, we hypothesized that the day-specific self-esteem experienced by one partner after work crosses over to the other partner. Furthermore, we proposed that this daily crossover process is moderated by…

  2. A Randomised, Cross-Over, Placebo-Controlled Study of Aloe vera in Patients with Irritable Bowel Syndrome: Effects on Patient Quality of Life.

    PubMed

    Hutchings, H A; Wareham, K; Baxter, J N; Atherton, P; Kingham, J G C; Duane, P; Thomas, L; Thomas, M; Ch'ng, C L; Williams, J G

    2011-01-01

    Background. Irritable bowel syndrome (IBS) is a chronic, difficult to treat condition. The efficacy of Aloe vera in treating IBS symptoms is not yet proven. The purpose of this study was to determine if Aloe vera is effective in improving quality of life. Methods. A multicentre, randomised, double-blind, cross-over placebo controlled study design. Patients were randomised to Aloe vera, wash-out, placebo or placebo, washout, Aloe vera. Each preparation (60 mL) was taken orally twice a day. Patient quality of life was measured using the Gastrointestinal Symptoms Rating Score, Irritable Bowel Syndrome Quality of Life, EuroQol and the Short-Form-12 at baseline and treatment periods 1 and 2. Results. A total of 110 patients were randomised, but only 47 completed all questionnaires and both study arms. Statistical analysis showed no difference between the placebo and Aloe vera treatment in quality of life. Discussion. This study was unable to show that Aloe vera was superior to placebo in improving quality of life. Drop outs and other confounding factors may have impacted on the power of the study to detect a clinically important difference. Conclusion. This study failed to find Aloe vera superior to placebo in improving quality of life proven Irritable Bowel Syndrome patients.

  3. Short-term effects of floods on Japanese encephalitis in Nanchong, China, 2007-2012: A time-stratified case-crossover study.

    PubMed

    Zhang, Feifei; Liu, Zhidong; Zhang, Caixia; Jiang, Baofa

    2016-09-01

    This time-stratified case-crossover study aimed to quantify the impact of floods on daily Japanese encephalitis (JE) cases from 2007 to 2012 in Nanchong city of Sichuan Province, China. Using conditional logistic regression analysis, we calculated the odds ratios (ORs) and 95% confidence intervals (CIs) at different lagged days, adjusting for daily average temperature (AT) and daily average relative humidity (ARH). A total of 370 JE cases were notified during the study period, with the median patient age being 4.2years. The seasonal pattern of JE cases clustered in July and August during the study period. Floods were significantly associated with an increased number of JE cases from lag 23 to lag 24, with the strongest lag effect at lag 23 (OR=2.00, 95% CI: 1.14-3.52). Similarly, AT and ARH were positively associated with daily JE cases from lag 0 to lag 8 and from lag 0 to lag 9, respectively. Floods, with AT and ARH, can be used to forecast JE outbreaks in the study area. Based on the results of this study, recommendations include undertaking control measures before the number of cases increases, especially for regions with similar geographic, climatic, and socio-economic conditions as those in the study area. PMID:27241207

  4. Interaction Effects of Temperature and Ozone on Lung Function and Markers of Systemic Inflammation, Coagulation, and Fibrinolysis: A Crossover Study of Healthy Young Volunteers

    PubMed Central

    Kahle, Juliette J.; Neas, Lucas M.; Devlin, Robert B.; Case, Martin W.; Schmitt, Michael T.; Madden, Michael C.

    2014-01-01

    Background: Trends in climate suggest that extreme weather events such as heat waves will become more common. High levels of the gaseous pollutant ozone are associated with elevated temperatures. Ozone has been associated with respiratory diseases as well as cardiovascular morbidity and mortality and can reduce lung function and alter systemic markers of fibrinolysis. The interaction between ozone and temperature is unclear. Methods: Sixteen healthy volunteers were exposed in a randomized crossover study to 0.3 ppm ozone and clean air for 2 hr at moderate (22°C) temperature and again at an elevated temperature (32.5°C). In each case lung function was performed and blood taken before and immediately after exposure and the next morning. Results: Ozone exposure at 22°C resulted in a decrease in markers of fibrinolysis the next day. There was a 51.8% net decrease in PAI-1 (plasminogen activator inhibitor-1), a 12.1% net decrease in plasminogen, and a 17.8% net increase in D-dimer. These significantly differed from the response at 32.5°C, where there was a 44.9% (p = 0.002) and a 27.9% (p = 0.001) increase in PAI-1 and plasminogen, respectively, and a 12.5% (p = 0.042) decrease in D-dimer. In contrast, decrements in lung function following ozone exposure were comparable at both moderate and elevated temperatures (forced expiratory volume in 1 sec, –12.4% vs. –7.5%, p > 0.05). No changes in systemic markers of inflammation were observed for either temperature. Conclusion: Ozone-induced systemic but not respiratory effects varied according to temperature. Our study suggests that at moderate temperature ozone may activate the fibrinolytic pathway, while at elevated temperature ozone may impair it. These findings provide a biological basis for the interaction between temperature and ozone on mortality observed in some epidemiologic studies. Citation: Kahle JJ, Neas LM, Devlin RB, Case MW, Schmitt MT, Madden MC, Diaz-Sanchez D. 2015. Interaction effects of

  5. A Time-Stratified Case-Crossover Study of Ambient Ozone Exposure and Emergency Department Visits for Specific Respiratory Diagnoses in California (2005–2008)

    PubMed Central

    Malig, Brian J.; Pearson, Dharshani L.; Chang, Yun Brenda; Broadwin, Rachel; Basu, Rupa; Green, Rochelle S.; Ostro, Bart

    2015-01-01

    Background: Studies have explored ozone’s connection to asthma and total respiratory emergency department visits (EDVs) but have neglected other specific respiratory diagnoses despite hypotheses relating ozone to respiratory infections and allergic responses. Objective: We examined relationships between ozone and EDVs for respiratory visits, including specifically acute respiratory infections (ARI), asthma, pneumonia, chronic obstructive pulmonary disease (COPD), and upper respiratory tract inflammation (URTI). Methods: We conducted a multi-site time-stratified case-crossover study of ozone exposures for approximately 3.7 million respiratory EDVs from 2005 through 2008 among California residents living within 20 km of an ozone monitor. Conditional logistic regression was used to estimate associations by climate zone. Random effects meta-analysis was then applied to estimate pooled excess risks (ER). Effect modification by season, distance from the monitor and individual demographic characteristics (i.e., age, race/ethnicity, sex, and payment method), and confounding by other gaseous air pollutants were also investigated. Meta-regression was utilized to explore how climate zone–level meteorological, demographic, and regional differences influenced estimates. Results: We observed ozone-associated increases in all respiratory, asthma, and ARI visits, which were slightly larger in the warm season [asthma ER per 10-ppb increase in mean of same and previous 3 days ozone exposure (lag03) = 2.7%, 95% CI: 1.5, 3.9; ARI ERlag03 = 1.4%, 95% CI: 0.8, 1.9]. EDVs for pneumonia, COPD, and URTI were also significantly associated with ozone exposure over the whole year, but typically more consistently so during the warm season. Conclusions: Short-term ozone exposures among California residents living near an ozone monitor were positively associated with EDVs for asthma, ARI, pneumonia, COPD, and URTI from 2005 through 2008. Those associations were typically larger and more

  6. A randomized, double-blind, placebo-controlled, cross-over study to evaluate analgesic activity of Terminalia chebula in healthy human volunteers using a mechanical pain model

    PubMed Central

    Pokuri, Venkata Kishan; Kumar, Chiranjeevi Uday; Pingali, Usharani

    2016-01-01

    Background and Aims: To evaluate analgesic activity and safety of single oral dose (1000 mg) of Terminalia chebula using a mechanical pain model in healthy human volunteers. Material and Methods: Twelve healthy volunteers were randomized to receive either single oral dose of 2 capsules of T. chebula 500 mg each or identical placebo capsules in a double-blinded manner. Mechanical pain was assessed using Ugo basile analgesy meter (Randall–Selitto test) before and 3 h after administration of test drug. The parameters evaluated were pain threshold force and time; pain tolerance force and time. A washout period of 1-week was given for crossover between active drug and placebo. Results: Terminalia chebula significantly increased the mean percentage change for pain threshold force and time, and pain tolerance force and time compared to placebo (P < 0.001). The mean percentage change for pain threshold force and time (20.8% and 21.0%) was increased more than that of pain tolerance force and time (13.4% and 13.4%). No adverse drug reaction was reported with either of the study medications during the study period. Conclusion: T. chebula significantly increased pain threshold and pain tolerance compared to placebo. Both the study medications were well tolerated. Further multiple dose studies may be needed to establish the analgesic efficacy of the drug in patients suffering from osteoarthritis, rheumatoid arthritis and other painful conditions. PMID:27625480

  7. Meiotic recombination protein Rec12: functional conservation, crossover homeostasis and early crossover/non-crossover decision

    PubMed Central

    Kan, Fengling; Davidson, Mari K.; Wahls, Wayne P.

    2011-01-01

    In fission yeast and other eukaryotes, Rec12 (Spo11) is thought to catalyze the formation of dsDNA breaks (DSBs) that initiate homologous recombination in meiosis. Rec12 is orthologous to the catalytic subunit of topoisomerase VI (Top6A). Guided by the crystal structure of Top6A, we engineered the rec12 locus to encode Rec12 proteins each with a single amino acid substitution in a conserved residue. Of 21 substitutions, 10 significantly reduced or abolished meiotic DSBs, gene conversion, crossover recombination and the faithful segregation of chromosomes. Critical residues map within the metal ion-binding pocket toprim (E179A, D229A, D231A), catalytic region 5Y-CAP (R94A, D95A, Y98F) and the DNA-binding interface (K201A, G202E, R209A, K242A). A subset of substitutions reduced DSBs but maintained crossovers, demonstrating crossover homeostasis. Furthermore, a strong separation of function mutation (R304A) suggests that the crossover/non-crossover decision is established early by a protein–protein interaction surface of Rec12. Fission yeast has multiple crossovers per bivalent, and chromosome segregation was robust above a threshold of about one crossover per bivalent, below which non-disjunction occurred. These results support structural and functional conservation among Rec12/Spo11/Top6A family members for the catalysis of DSBs, and they reveal how Rec12 regulates other features of meiotic chromosome dynamics. PMID:21030440

  8. Meiotic recombination protein Rec12: functional conservation, crossover homeostasis and early crossover/non-crossover decision.

    PubMed

    Kan, Fengling; Davidson, Mari K; Wahls, Wayne P

    2011-03-01

    In fission yeast and other eukaryotes, Rec12 (Spo11) is thought to catalyze the formation of dsDNA breaks (DSBs) that initiate homologous recombination in meiosis. Rec12 is orthologous to the catalytic subunit of topoisomerase VI (Top6A). Guided by the crystal structure of Top6A, we engineered the rec12 locus to encode Rec12 proteins each with a single amino acid substitution in a conserved residue. Of 21 substitutions, 10 significantly reduced or abolished meiotic DSBs, gene conversion, crossover recombination and the faithful segregation of chromosomes. Critical residues map within the metal ion-binding pocket toprim (E179A, D229A, D231A), catalytic region 5Y-CAP (R94A, D95A, Y98F) and the DNA-binding interface (K201A, G202E, R209A, K242A). A subset of substitutions reduced DSBs but maintained crossovers, demonstrating crossover homeostasis. Furthermore, a strong separation of function mutation (R304A) suggests that the crossover/non-crossover decision is established early by a protein-protein interaction surface of Rec12. Fission yeast has multiple crossovers per bivalent, and chromosome segregation was robust above a threshold of about one crossover per bivalent, below which non-disjunction occurred. These results support structural and functional conservation among Rec12/Spo11/Top6A family members for the catalysis of DSBs, and they reveal how Rec12 regulates other features of meiotic chromosome dynamics. PMID:21030440

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

    PubMed Central

    Patiño-Rodríguez, Omar; Martínez-Medina, Rosa María; Torres-Roque, Irma; Martínez-Delgado, Maricela; Mares-García, América Susana; Escobedo-Moratilla, Abraham; Covarrubias-Pinedo, Amador; Arzola-Paniagua, Angélica; Herrera-Torres, José Luis

    2015-01-01

    Several clinical trials have substantiated the efficacy of the co-administration of statins like atorvastatin (ATO) and fibrates. Without information currently available about the interaction between the two drugs, a pharmacokinetic study was conducted to investigate the effect when both drugs were co-administered. The purpose of this study was to investigate the pharmacokinetic profile of tablets containing ATO 20 mg, or the combination of ATO 20 mg with fenofibrate (FNO) 160 mg administered to healthy Mexican volunteers. This was a randomized, two-period, two-sequence, crossover study; 36 eligible subjects aged between 20–50 years were included. Blood samples were collected up to 96 h after dosing, and pharmacokinetic parameters were obtained by non-compartmental analysis. Adverse events were evaluated based on subject interviews and physical examinations. Area under the concentration-time curve (AUC) and maximum plasma drug concentration (Cmax) were measured for ATO as the reference and ATO and FNO as the test product for bioequivalence design. The estimation computed (90% confidence intervals) for ATO and FNO combination versus ATO for Cmax, AUC0-t and AUC0-∞, were 102,09, 125,95, and 120,97%, respectively. These results suggest that ATO and FNO have no relevant clinical-pharmacokinetic drug interaction. PMID:25688207

  10. The Tulip GT® airway versus the facemask and Guedel airway: a randomised, controlled, cross-over study by Basic Life Support-trained airway providers in anaesthetised patients.

    PubMed

    Shaikh, A; Robinson, P N; Hasan, M

    2016-03-01

    We performed a randomised, controlled, cross-over study of lung ventilation by Basic Life Support-trained providers using either the Tulip GT® airway or a facemask with a Guedel airway in 60 anaesthetised patients. Successful ventilation was achieved if the provider produced an end-tidal CO2 > 3.5 kPa and a tidal volume > 250 ml in two of the first three breaths, within 60 sec and within two attempts. Fifty-seven (95%) providers achieved successful ventilation using the Tulip GT compared with 35 (58%) using the facemask (p < 0.0001). Comparing the Tulip GT and facemask, the mean (SD) end-tidal CO2 was 5.0 (0.7) kPa vs 2.5 (1.5) kPa, tidal volume was 494 (175) ml vs 286 (186) ml and peak inspiratory pressure was 18.3 (3.4) cmH2 O vs 13.6 (7) cmH2 O respectively (all p < 0.0001). Forty-seven (78%) users favoured the Tulip GT airway. These results are similar to a previous manikin study using the same protocol, suggesting a close correlation between human and manikin studies for this airway device. We conclude that the Tulip GT should be considered as an adjunct to airway management both within and outside hospitals when ventilation is being undertaken by Basic Life Support-trained airway providers. PMID:26684684

  11. Caffeine counteracts impairments in task-oriented psychomotor performance induced by chlorpheniramine: a double-blind placebo-controlled crossover study.

    PubMed

    Kim, Sung-Wan; Bae, Kyung-Yeol; Shin, Hee-Young; Kim, Jae-Min; Shin, Il-Seon; Kim, Jong-Keun; Kang, Gaeun; Yoon, Jin-Sang

    2013-01-01

    This study aimed to evaluate the effects of chlorpheniramine on psychomotor performance and the counteracting effects of caffeine on those sedative antihistamine actions. Sixteen healthy young men participated in this study. Using a double-blind placebo-controlled crossover design, each subject was administered one of the following conditions in a random order with a one-week interval: 'placebo-placebo', '4 mg of chlorpheniramine-placebo', 'placebo-200 mg of caffeine' or '4 mg of chlorpheniramine-200 mg of caffeine'. Before and after the treatments, psychomotor functions were assessed using a battery of tests. Additionally, subjective responses were assessed using a visual analogue scale (VAS). Psychomotor performance changed over time in different ways according to the combination of study medications. In the 'chlorpheniramine-placebo' condition, reaction times of the compensatory tracking task were significantly impaired compared with the other three conditions. In addition, the number of omission errors of the continuous performance test were significantly greater compared with the 'placebo-caffeine' condition. However, the response pattern of the 'chlorpheniramine-caffeine' condition was not significantly different from that of the 'placebo-placebo' condition. Changes of VAS for sleepiness were significantly greater in the 'chlorpheniramine-placebo' condition compared with the other three conditions. In conclusion, chlorpheniramine significantly increases subjective sleepiness and objectively impairs psychomotor performance. However, caffeine counteracts these sedative effects and psychomotor impairments.

  12. A randomised, crossover study on an electronic vapour product, a nicotine inhalator and a conventional cigarette. Part B: Safety and subjective effects.

    PubMed

    Walele, Tanvir; Sharma, Girish; Savioz, Rebecca; Martin, Claire; Williams, Josie

    2016-02-01

    An Electronic Vapour Product (EVP) has been evaluated for short-term safety parameters and subjective effects in a 2-part study, in smokers. Part 1 compared the EVP with unflavoured (UF) and flavoured (FL) e-liquid at 2.0% nicotine to a conventional cigarette (CC; JPS Silver King Size, 0.6 mg) and a licensed nicotine inhalator (Nicorette(®), 15 mg). Part 2 assessed the effect of increasing concentrations of nicotine in the e-liquid used with the EVP (0%, 0.4%, 0.9%, 2.0%). The study was designed as a randomised, controlled, crossover trial. Outcomes included adverse events (AEs), vital signs, exhaled carbon monoxide (CO), clinical laboratory parameters, smoking urges and withdrawal symptoms. In both study parts, only mild non-serious AEs were reported. No major differences were observed in AEs between the EVPs and Nicorette(®). Exhaled CO levels only increased for CC. All products appeared to decrease smoking urges and nicotine withdrawal symptom scores to a similar extent. The EVP had a similar short-term safety profile to Nicorette(®) and relieved smoking urges and nicotine withdrawal symptoms to a similar extent as Nicorette(®) and CC. Unlike nicotine replacement therapies, the EVP may offer an alternative for those finding it difficult to quit the behavioural and sensorial aspects of smoking.

  13. Effect of NR-Salacia on post-prandial hyperglycemia: A randomized double blind, placebo-controlled, crossover study in healthy volunteers

    PubMed Central

    Koteshwar, Pravina; Raveendra, Kadur Ramamurthy; Allan, Joseph Joshua; Goudar, Krishnagouda Shankargouda; Venkateshwarlu, Kudiganti; Agarwal, Amit

    2013-01-01

    Background: Salacia chinensis (S. chinensis) is widely distributed in India and Sri Lanka. Most of the species of genus Salacia are known to have effects on blood glucose levels; however, the effects of S. chinensis on glucose levels are seldom reported. Objective: To evaluate the oral hypoglycemic activity of NR- Salacia (1000 mg extract of S. chinensis) in healthy adults. Materials and Methods: Randomized, double-blind, placebo-controlled, cross-over study was conducted in healthy volunteers. Single dose of NR-Salacia (1000 mg extract of Salacia chinensis) and placebo were administered before carbohydrate-rich diet. A 6-point plasma glucose profile was performed at different time intervals up to 180 min. Results: NR-Salacia treatment significantly lowered plasma glucose level at 90 min, and the percentage reduction in glucose concentration was found to be 13.32 as compared to placebo group. A 33.85% decrease in the plasma glucose positive incremental area under curve (AUC) (0 to 180 min) was observed in comparison to placebo. No adverse events were recorded throughout the study period, except for some mild cases of abdominal discomforts like cramping and distention, vomiting, and headache in both placebo and NR-Salacia-treated groups. Conclusion: The study findings revealed that NR-Salacia lowered the post-prandial plasma glucose levels after a carbohydrate-rich meal and can be used as an oral hypoglycemic agent. PMID:24124287

  14. The Tulip GT® airway versus the facemask and Guedel airway: a randomised, controlled, cross-over study by Basic Life Support-trained airway providers in anaesthetised patients.

    PubMed

    Shaikh, A; Robinson, P N; Hasan, M

    2016-03-01

    We performed a randomised, controlled, cross-over study of lung ventilation by Basic Life Support-trained providers using either the Tulip GT® airway or a facemask with a Guedel airway in 60 anaesthetised patients. Successful ventilation was achieved if the provider produced an end-tidal CO2 > 3.5 kPa and a tidal volume > 250 ml in two of the first three breaths, within 60 sec and within two attempts. Fifty-seven (95%) providers achieved successful ventilation using the Tulip GT compared with 35 (58%) using the facemask (p < 0.0001). Comparing the Tulip GT and facemask, the mean (SD) end-tidal CO2 was 5.0 (0.7) kPa vs 2.5 (1.5) kPa, tidal volume was 494 (175) ml vs 286 (186) ml and peak inspiratory pressure was 18.3 (3.4) cmH2 O vs 13.6 (7) cmH2 O respectively (all p < 0.0001). Forty-seven (78%) users favoured the Tulip GT airway. These results are similar to a previous manikin study using the same protocol, suggesting a close correlation between human and manikin studies for this airway device. We conclude that the Tulip GT should be considered as an adjunct to airway management both within and outside hospitals when ventilation is being undertaken by Basic Life Support-trained airway providers.

  15. Hybrid spin-crossover nanostructures

    PubMed Central

    Quintero, Carlos M; Félix, Gautier; Suleimanov, Iurii; Sánchez Costa, José; Molnár, Gábor; Salmon, Lionel; Nicolazzi, William

    2014-01-01

    Summary This review reports on the recent progress in the synthesis, modelling and application of hybrid spin-crossover materials, including core–shell nanoparticles and multilayer thin films or nanopatterns. These systems combine, often in synergy, different physical properties (optical, magnetic, mechanical and electrical) of their constituents with the switching properties of spin-crossover complexes, providing access to materials with unprecedented capabilities. PMID:25551051

  16. Inhaled and systemic corticosteroid response in severe asthma assessed by alveolar nitric oxide: a randomized crossover pilot study of add-on therapy

    PubMed Central

    Williamson, Peter A; Short, Philip M; Vaidyanathan, Sriram; Lipworth, Brian J

    2013-01-01

    AIMS Alveolar nitric oxide (CANO) is a potential biomarker of small airway inflammation. We investigated effects on CANO of the addition of coarse and fine particle inhaled corticosteroids to standard therapy in severe asthma. METHODS Severe asthmatics taking ≥1600 µg day−1 budesonide or equivalent performed a randomized open-label crossover study. Subjects with FEV1 < 80%, gas trapping and CANO≥2 ppb entered a 6 week dose-ramp run-in of fluticasone/salmeterol(FPSM) 250/50 µg twice daily for 3 weeks, then 500/50 µg twice daily for 3 weeks. Patients then received additional HFA-beclomethasone diproprionate (BDP) 200 µg twice daily or FP 250 µg twice daily for 3 weeks in a crossover. Participants then received prednisolone(PRED) 25 mg day−1 for 1 week. Nitric oxide, lung function, mannitol challenge, systemic inflammatory markers and urinary cortisol were measured. RESULTS Fifteen completed per protocol: mean (SD) age 51 (12) years, FEV1 58 (13)% predicted, residual volume 193 (100)% predicted and mannitolPD10 177 (2.8) µg. There was no significant difference between FPSM and add-on therapy for CANO. FPSM/BDP and FPSM/PRED suppressed broncial flux (JawNO) and FENO compared with FPSM alone, but there was no significant difference between FPSM/BDP and FPSM/FP. ECP, e-selectin and ICAM-1 were suppressed by FPSM/PRED compared with FPSM and FPSM/FP but not FPSM/BDP. Plasma cortisol was significantly suppressed by FPSM/PRED. CONCLUSION In severe asthma, CANO is insensitive to changes in dose and delivery of inhaled corticosteroids and is not suppressed by systemic corticosteroids. Additional inhaled HFA-BDP reduced FENO and JawNO without adrenal suppression. There was a trend to reduction in FENO and JawNO with additional FP but this did not reach statistical significance. PRED reduced FENO and JawNO with suppression of systemic inflammatory markers and urinary cortisol. PMID:22568828

  17. Cyclosporine and Extracorporeal Photopheresis are Equipotent in Treating Severe Atopic Dermatitis: A Randomized Cross-Over Study Comparing Two Efficient Treatment Modalities

    PubMed Central

    Koppelhus, Uffe; Poulsen, Johan; Grunnet, Niels; Deleuran, Mette Søndergaard; Obitz, Erik

    2014-01-01

    Background: Severe atopic dermatitis (AD) is a recurrent and debilitating disease often requiring systemic immunosuppressive treatment. The efficacy of cyclosporine A (CsA) is well proven but potential side effects are concerning. Several reports point at extracorporeal photopheresis (ECP) as an alternative treatment modality with few and mild side effects. However, no direct comparison between CsA and ECP in the treatment of AD has been performed so far. Objectives: To compare the efficacy of CsA (3 mg/kg/day) and ECP (administered two consecutive days twice a month) in a cohort of patients with severe AD. Methods: A randomized cross-over study involving twenty patients with severe AD (SCORAD index 41-89) refractory to other treatments. The patients were allocated to a 4-month course of either of the two treatment modalities. Individual relapse periods (2–8 weeks) were interspersed before cross-over to the other treatment modality. Treatment efficacy was evaluated by SCORAD, PRURITUS (VAS-index 0–10), “overall global assessment” and serological biomarkers; sIL-2Rα, sE-selectin, eosinophilocytes, basophilocytes, and sIgE. Results: 15 patients completed treatment. Both treatments lead to a marked and significant decrease in SCORAD and pruritus index. The average reduction of the SCORAD and pruritus index, respectively was a little higher for ECP treatment compared to CsA treatment; however, the differences did not reach statistical significance. The “overall global assessment” was significantly better in patients who underwent ECP therapy as compared to CsA treatment. None of the biomarkers showed significant changes after either treatment when compared to the initial values. Conclusion: ECP administered on two consecutive days twice a month to patients with severe AD has similar potency as CsA administered daily in a moderate dose. ECP is a treatment alternative in patients with severe AD that do not tolerate or are refractory to conventional

  18. Acute reduction in blood pressure following consumption of anthocyanin-rich cherry juice may be dose-interval dependant: a pilot cross-over study.

    PubMed

    Kent, Katherine; Charlton, Karen E; Jenner, Andrew; Roodenrys, Steven

    2016-01-01

    A pilot cross-over study assessed the acute effects on blood pressure and plasma biomarkers associated with consumption of a 300 ml anthocyanin-rich fruit juice, provided in differing dose-intervals. Young adults (n = 6) and older adults (n = 7) received in random order, either a single 300 ml dose or 3 × 100 ml doses of high-flavonoid cherry juice provided at 0, 1 and 2 h. Blood pressure and plasma levels of phenolic metabolites were measured at 0, 2 and 6 h.The single 300 ml dose of cherry juice resulted in a significant reduction in systolic (p = 0.002), and diastolic blood pressure (p = 0.008) and heart-rate (p = 0.033) 2 h after consumption, before returning to baseline levels at 6 h post-consumption. The 3 × 100 ml dose provided over 2 h did not result in significant blood pressure reductions. Plasma phenolic metabolites increased at 2 and 6 h; however, fluctuations were higher after the single 300 ml dose in older adults. These findings have implications for design of intervention studies that investigate vascular effects associated with flavonoid-rich foods. PMID:26654244

  19. A Phase 1, Randomized, Single-Dose Crossover Pharmacokinetic Study to Investigate the Effect of Food Intake on Absorption of Orteronel (TAK-700) in Healthy Male Subjects.

    PubMed

    Suri, Ajit; Pham, Theresa; MacLean, David B

    2016-05-01

    This study aimed to determine the impact of food on the pharmacokinetics of orteronel, an investigational nonsteroidal, reversible selective inhibitor of 17,20-lyase. In this open-label, randomized crossover study, healthy subjects received single doses of orteronel 400 mg with a low-fat meal, a high-fat meal, and under fasting conditions in a randomized sequence. Plasma concentrations of orteronel and its primary M-I metabolite were determined by ultra-performance liquid chromatography, and pharmacokinetic parameters were evaluated using mixed-effects analysis of variance model. Compared with fasting conditions, the oral bioavailability of orteronel was increased under fed conditions. The least-squares mean ratio for area under the plasma concentration-time curve after a low-fat breakfast was 135% (90% confidence interval [CI], 126%-145%) compared with fasting conditions. Similarly, after a high-fat breakfast, the corresponding value was 142% (90%CI, 132%-152%). No unexpected safety concerns were raised with orteronel 400 mg administered in the fasted state or after either a high-fat or a low-fat meal; mild adverse events were experienced by 36% of the healthy male subjects. PMID:27163497

  20. Likelihood ratio and score tests to test the non-inferiority (or equivalence) of the odds ratio in a crossover study with binary outcomes.

    PubMed

    Li, Xiaochun; Li, Huilin; Jin, Man; D Goldberg, Judith

    2016-09-10

    We consider the non-inferiority (or equivalence) test of the odds ratio (OR) in a crossover study with binary outcomes to evaluate the treatment effects of two drugs. To solve this problem, Lui and Chang (2011) proposed both an asymptotic method and a conditional method based on a random effects logit model. Kenward and Jones (1987) proposed a likelihood ratio test (LRTM ) based on a log linear model. These existing methods are all subject to model misspecification. In this paper, we propose a likelihood ratio test (LRT) and a score test that are independent of model specification. Monte Carlo simulation studies show that, in scenarios considered in this paper, both the LRT and the score test have higher power than the asymptotic and conditional methods for the non-inferiority test; the LRT, score, and asymptotic methods have similar power, and they all have higher power than the conditional method for the equivalence test. When data can be well described by a log linear model, the LRTM has the highest power among all the five methods (LRTM , LRT, score, asymptotic, and conditional) for both non-inferiority and equivalence tests. However, in scenarios for which a log linear model does not describe the data well, the LRTM has the lowest power for the non-inferiority test and has inflated type I error rates for the equivalence test. We provide an example from a clinical trial that illustrates our methods. Copyright © 2016 John Wiley & Sons, Ltd. PMID:27095359

  1. Likelihood ratio and score tests to test the non-inferiority (or equivalence) of the odds ratio in a crossover study with binary outcomes.

    PubMed

    Li, Xiaochun; Li, Huilin; Jin, Man; D Goldberg, Judith

    2016-09-10

    We consider the non-inferiority (or equivalence) test of the odds ratio (OR) in a crossover study with binary outcomes to evaluate the treatment effects of two drugs. To solve this problem, Lui and Chang (2011) proposed both an asymptotic method and a conditional method based on a random effects logit model. Kenward and Jones (1987) proposed a likelihood ratio test (LRTM ) based on a log linear model. These existing methods are all subject to model misspecification. In this paper, we propose a likelihood ratio test (LRT) and a score test that are independent of model specification. Monte Carlo simulation studies show that, in scenarios considered in this paper, both the LRT and the score test have higher power than the asymptotic and conditional methods for the non-inferiority test; the LRT, score, and asymptotic methods have similar power, and they all have higher power than the conditional method for the equivalence test. When data can be well described by a log linear model, the LRTM has the highest power among all the five methods (LRTM , LRT, score, asymptotic, and conditional) for both non-inferiority and equivalence tests. However, in scenarios for which a log linear model does not describe the data well, the LRTM has the lowest power for the non-inferiority test and has inflated type I error rates for the equivalence test. We provide an example from a clinical trial that illustrates our methods. Copyright © 2016 John Wiley & Sons, Ltd.

  2. A Randomised, Cross-Over Study to Estimate the Influence of Food on the 25-Hydroxyvitamin D₃ Serum Level after Vitamin D₃ Supplementation.

    PubMed

    Cavalier, Etienne; Jandrain, Bernard; Coffiner, Monte; Da Silva, Stéphanie; De Niet, Sophie; Vanderbist, Francis; Souberbielle, Jean-Claude

    2016-01-01

    Vitamin D₃ is known to be liposoluble and its release could be a factor limiting the rate of absorption. It was presumed that the presence of fat could favor absorption of vitamin D₃. However, as bioavailability is related not only to the active molecules but also to the formulations and excipients used, the optimization of the pharmaceutical form of vitamin D₃ is also important. The objective of this study was to evaluate if there is a food effect on absorption when a high dose of vitamin D₃ is completely solubilized in an oily solution. In the present cross-over study, 88 subjects were randomized and received a single dose of 50,000 IU of vitamin D₃ in fasting state or with a standardized high-fat breakfast. Assessment of serum concentrations of 25 hydroxyvitamin D₃ (25(OH)D₃) was performed three, five, seven, 14, 30 and 60 days after supplementation. In fed and fast conditions, the 25(OH)D₃ serum concentrations were significantly higher than the baseline value three days after administration and remained significantly higher during the first month. No significant difference between fasting vs. fed conditions was observed. It is therefore concluded that the vitamin D₃ absorption from an oily solution was not influenced by the presence or absence of a meal. PMID:27213447

  3. A double-blind, crossover study of Biotène Oralbalance and BioXtra systems as salivary substitutes in patients with post-radiotherapy xerostomia.

    PubMed

    Shahdad, S A; Taylor, C; Barclay, S C; Steen, I N; Preshaw, P M

    2005-09-01

    This study assessed the efficacy of the Bioxtra (BX) and Biotène Oralbalance (OB) systems in the treatment of post-radiotherapy xerostomia. In a double-blind, crossover study, 20 patients with post-radiotherapy xerostomia were randomly allocated to receive either OB then BX, or vice versa, each product for 2 weeks, with a 1 week wash-out period in between. Subject-based dry mouth scores derived from 100-mm visual analogue scales were recorded at days 0 and 14 of each 2-week period, together with subjective perception of changes in dry mouth symptoms. Both treatments were effective, resulting in reduction of visual analogue scale scores from day 0-14. Between-groups comparisons identified that BX achieved significantly better improvements compared with OB for the perception of dry mouth and improvements in speech and was also rated as more pleasant to use than OB (P < 0.05). In conclusion, both treatments were effective in alleviating the symptoms of post-radiotherapy xerostomia, although BX achieved superiority in some of the outcomes assessed compared with OB.

  4. Short-term effects of fine particulate air pollution on emergency room visits for cardiac arrhythmias: a case-crossover study in Taipei.

    PubMed

    Chiu, Hui-Fen; Tsai, Shang-Shyue; Weng, Hsu-Huei; Yang, Chun-Yuh

    2013-01-01

    This study was undertaken to determine whether there was an association between fine particles (PM₂.₅) levels and number of emergency room (ER) visits for cardiac arrhythmias in Taipei, Taiwan. ER visits for cardiac arrhythmias and ambient air pollution data for Taipei were obtained for the period 2006-2010. The relative risk (RR) of ER visits was estimated using a case-crossover approach, controlling for weather variables, day of the week, seasonality, and long-term time trends. For the single-pollutant model (without adjustment for other pollutants), increased numbers of ER cardiac arrhythmia visits were significantly associated with PM₂.₅ on both warm days (>23°C) and cool days (< 23°C), with an interquartile range rise associated with a 10% (95% CI = -15%) and 4% (95% CI = 0-8%) elevation in number of ER visits for cardiac arrhythmias, respectively. In the two-pollutant models, PM₂.₅ levels remained significant after inclusion of sulfur dioxide (SO₂) or ozone (O₃) on both warm and cool days. This study provides evidence that higher levels of PM₂.₅ increase the risk of number of ER visits for cardiac arrhythmias.

  5. [A Crossover Comparison Study on Lower Urinary Tract Symptoms with Overactive Bladder Secondary to Benign Prostatic Hyperplasia: Naftopidil versus Tamsulosin with Solifenacin].

    PubMed

    Utsunomiya, Noriaki; Matsumoto, Keiyu; Tsunemori, Hiroyuki; Muguruma, Koei; Kawakita, Mutsushi; Kamiyama, Yuki; Kanamaru, Sojun; Ito, Noriyuki; Tsukazaki, Hideki; Shirahase, Toshiaki; Takahashi, Takeshi

    2016-07-01

    We compared the efficacy of naftopidil monotherapy with combination therapy using tamsulosin hydrochloride and solifenacin succinate in the treatment of lower urinary tract symptoms (LUTS) with overactive bladder (OAB) secondary to benign prostatic hyperplasia (BPH). Thirty one patients were enrolled in a randomized crossover study. Fourteen patients were initially prescribed naftopidil 75 mg (N) for 8 weeks, followed by tamsulosin 0.2 mg and solifenacin 5 mg (TS) for 8 weeks (group N) ; another 17 were initially prescribed TS, followed by N (group TS). The efficacy variables were the changes in international prostate symptom score (I-PSS), quality of life (QOL) score, overative bladder symptom score (OABSS), and post-void residual (PVR) urine volume. After the study, a questionnaire survey was carried out about the choice of treatment. After treatment with each agent, total I-PSS, storage symptom score, QOL score and OABSS except for the daytime frequency were significantly improved from baseline. PVR was significantly increased after TS treatment. There were no significant differences between the two treatments except for PVR. As a result of the questionnaire survey, 13 patients chose N and 17 chose TS. In conclusion, N monotherapy can be expected to have an equal effect in the treatment of LUTS with OAB secondary to BPH in comparison with TS combination therapy. PMID:27569351

  6. Muscle-Derived IL-6 Is Not Regulated by IL-1 during Exercise. A Double Blind, Placebo-Controlled, Randomized Crossover Study

    PubMed Central

    Cordes, Mareike; Coslovsky, Michael; Hanssen, Henner; Schmidt-Trucksäss, Arno; Donath, Marc Y.

    2015-01-01

    Exercise increases muscle derived Interleukin–6 (IL–6) leading to insulin secretion via glucagon-like peptide–1. IL–1 antagonism improves glycemia and decreases systemic inflammation including IL–6 in patients with type 2 diabetes. However, it is not known whether physiological, exercise-induced muscle-derived IL–6 is also regulated by the IL–1 system. Therefore we conducted a double blind, crossover study in 17 healthy male subjects randomized to receive either the IL–1 receptor antagonist IL-1Ra (anakinra) or placebo prior to an acute treadmill exercise. Muscle activity led to a 2–3 fold increase in serum IL–6 concentrations but anakinra had no effect on this exercise-induced IL–6. Furthermore, the IL–1 responsive inflammatory markers CRP, cortisol and MCP–1 remained largely unaffected by exercise and anakinra. We conclude that the beneficial effect of muscle-induced IL–6 is not meaningfully affected by IL–1 antagonism. Trial Registration ClinicalTrials.gov NCT01771445 PMID:26448147

  7. Muscle Activation of Vastus Medialis Oblique and Vastus Lateralis in Sling-Based Exercises in Patients with Patellofemoral Pain Syndrome: A Cross-Over Study.

    PubMed

    Chang, Wen-Dien; Huang, Wei-Syuan; Lai, Ping-Tung

    2015-01-01

    Objectives. To examine what changes are caused in the activity of the vastus medialis oblique (VMO) and vastus lateralis (VL) at the time of sling-based exercises in patients with patellofemoral pain syndrome (PFPS) and compare the muscular activations in patients with PFPS among the sling-based exercises. Methods. This was a cross-over study. Sling-based open and closed kinetic knee extension and hip adduction exercises were designed for PFPS, and electromyography was applied to record maximal voluntary contraction during the exercises. The VMO and VL activations and VMO : VL ratios for the three exercises were analyzed and compared. Results. Thirty male (age = 21.19 ± 0.68 y) and 30 female (age = 21.12 ± 0.74 y) patients with PFPS were recruited. VMO activations during the sling-based open and closed kinetic knee extension exercises were significantly higher (P = 0.04 and P = 0.001) than those during hip adduction exercises and VMO : VL ratio for the sling-based closed kinetic knee extension and hip adduction exercises approximated to 1. Conclusions. The sling-based closed kinetic knee extension exercise produced the highest VMO activation. It also had an appropriate VMO : VL ratio similar to sling-based hip adduction exercise and had beneficial effects on PFPS. PMID:26504480

  8. Study design and methods for a randomized crossover trial substituting brown rice for white rice on diabetes risk factors in India.

    PubMed

    Wedick, Nicole M; Sudha, Vasudevan; Spiegelman, Donna; Bai, Mookambika Ramya; Malik, Vasanti S; Venkatachalam, Siva Sankari; Parthasarathy, Vijayalaksmi; Vaidya, Ruchi; Nagarajan, Lakshmipriya; Arumugam, Kokila; Jones, Clara; Campos, Hannia; Krishnaswamy, Kamala; Willett, Walter; Hu, Frank B; Anjana, Ranjit Mohan; Mohan, Viswanathan

    2015-01-01

    India has the second largest number of people with diabetes in the world following China. Evidence indicates that consumption of whole grains can reduce the risk of type 2 diabetes. This article describes the study design and methods of a trial in progress evaluating the effects of substituting whole grain brown rice for polished (refined) white rice on biomarkers of diabetes risk (glucose metabolism, dyslipidemia, inflammation). This is a randomized controlled clinical trial with a crossover design conducted in Chennai, India among overweight but otherwise healthy volunteers aged 25-65 y with a body mass index ≥23 kg/m(2) and habitual rice consumption ≥200 g/day. The feasibility and cultural appropriateness of this type of intervention in the local environment will also be examined. If the intervention is efficacious, the findings can be incorporated into national-level policies which could include the provision of brown rice as an option or replacement for white rice in government institutions and food programs. This relatively simple dietary intervention has the potential to substantially diminish the burden of diabetes in Asia and elsewhere.

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

    PubMed Central

    Tawasri, Patcharanee; Ampasavate, Chadarat; Tharatha, Somsak

    2016-01-01

    The objective of this randomized, open-label, single-dose, two-phase crossover study was to determine the effect of ascorbic acid on pharmacokinetics of ganoderic acid A, an important biologically active triterpenoid compound with anticancer activities, following oral administration of water extract of fruiting bodies of Ling Zhi in 12 healthy male subjects. Each subject was randomized to receive either one of the two regimens: (1) a single dose of 3,000 mg of the Ling Zhi preparation or (2) a single dose of 3,000 mg of the Ling Zhi preparation in combination with 2,500 mg of ascorbic acid. After a washout period of at least two weeks, subjects were switched to receive the alternate regimen. Blood samples were collected in each phase immediately before dosing and at specific time points for 8 hours after dosing. Plasma ganoderic acid A concentrations were quantified using liquid chromatography-mass spectrometry (LC-MS). The pharmacokinetic parameters analyzed were maximal plasma concentration (Cmax), time to reach peak concentration (Tmax), area under the plasma concentration-time curve (AUC), and half-life (t1/2). An oral coadministration of ascorbic acid with Ling Zhi preparation did not significantly alter the pharmacokinetic parameters of ganoderic acid A in healthy male subjects. PMID:27747224

  10. Study design and methods for a randomized crossover trial substituting brown rice for white rice on diabetes risk factors in India

    PubMed Central

    Wedick, Nicole M.; Vasudevan, Sudha; Spiegelman, Donna; Bai, Ramya; Malik, Vasanti; Venkatachalam, Siva Sankari; Parthasarathy, Vijayalaksmi; Vaidya, Ruchi; Nagarajan, Lakshmipriya; Arumugam, Kokila; Jones, Clara; Campos, Hannia; Krishnaswamy, Kamala; Willett, Walter; Hu, Frank B.; Mohan, Anjana Ranjit; Viswanathan, Mohan

    2016-01-01

    India has the second largest number of people with diabetes in the world following China. Evidence indicates that consumption of whole grains can reduce risk of type 2 diabetes. This manuscript describes the study design and methods of a trial in progress evaluating the effects of substituting whole grain brown rice for polished (refined) white rice on biomarkers of diabetes risk (glucose metabolism, dyslipidemia, inflammation). This is a randomized controlled clinical trial with a crossover design conducted in Chennai, India among overweight but otherwise healthy volunteers aged 25–65y with a body mass index ≥23kg/m2 and habitual rice consumption ≥200grams/day. The feasibility and cultural appropriateness of this type of intervention in the local environment will also be examined. If the intervention is efficacious, the findings can be incorporated into national-level policies which could include the provision of brown rice as an option or replacement for white rice in government institutions and food programs. This relatively simple dietary intervention has the potential to substantially diminish the burden of diabetes in Asia and elsewhere. PMID:26017321

  11. Muscle Activation of Vastus Medialis Oblique and Vastus Lateralis in Sling-Based Exercises in Patients with Patellofemoral Pain Syndrome: A Cross-Over Study

    PubMed Central

    Chang, Wen-Dien; Huang, Wei-Syuan; Lai, Ping-Tung

    2015-01-01

    Objectives. To examine what changes are caused in the activity of the vastus medialis oblique (VMO) and vastus lateralis (VL) at the time of sling-based exercises in patients with patellofemoral pain syndrome (PFPS) and compare the muscular activations in patients with PFPS among the sling-based exercises. Methods. This was a cross-over study. Sling-based open and closed kinetic knee extension and hip adduction exercises were designed for PFPS, and electromyography was applied to record maximal voluntary contraction during the exercises. The VMO and VL activations and VMO : VL ratios for the three exercises were analyzed and compared. Results. Thirty male (age = 21.19 ± 0.68 y) and 30 female (age = 21.12 ± 0.74 y) patients with PFPS were recruited. VMO activations during the sling-based open and closed kinetic knee extension exercises were significantly higher (P = 0.04 and P = 0.001) than those during hip adduction exercises and VMO : VL ratio for the sling-based closed kinetic knee extension and hip adduction exercises approximated to 1. Conclusions. The sling-based closed kinetic knee extension exercise produced the highest VMO activation. It also had an appropriate VMO : VL ratio similar to sling-based hip adduction exercise and had beneficial effects on PFPS. PMID:26504480

  12. In vitro template-change PCR to create single crossover libraries: a case study with B. thuringiensis Cry2A toxins

    PubMed Central

    Shu, Changlong; Zhou, Jianqiao; Crickmore, Neil; Li, Xianchun; Song, Fuping; Liang, Gemei; He, Kanglai; Huang, Dafang; Zhang, Jie

    2016-01-01

    During evolution the creation of single crossover chimeras between duplicated paralogous genes is a known process for increasing diversity. Comparing the properties of homologously recombined chimeras with one or two crossovers is also an efficient strategy for analyzing relationships between sequence variation and function. However, no well-developed in vitro method has been established to create single-crossover libraries. Here we present an in vitro template-change polymerase change reaction that has been developed to enable the production of such libraries. We applied the method to two closely related toxin genes from B. thuringiensis and created chimeras with differing properties that can help us understand how these toxins are able to differentiate between insect species. PMID:27097519

  13. Analgesic and antihyperalgesic effects of melatonin in a human inflammatory pain model: a randomized, double-blind, placebo-controlled, three-arm crossover study.

    PubMed

    Andersen, Lars P H; Gögenur, Ismail; Fenger, Andreas Q; Petersen, Marian C; Rosenberg, Jacob; Werner, Mads U

    2015-11-01

    Antinociceptive effects of melatonin have been documented in a wide range of experimental animal models. The aim of this study was to investigate the analgesic, antihyperalgesic, and anti-inflammatory properties of melatonin using a validated burn injury (BI) model in healthy male volunteers. The design was a randomized, double-blind, placebo-controlled, three-arm crossover study. Each volunteer participated in 3 identical study sessions with intravenous administration of placebo, melatonin 10 mg, or melatonin 100 mg. Sixty minutes after bolus injection of study medication, a BI was induced by a computerized contact thermode (47.0°C, 420 seconds, 5.0 × 2.5 cm). Pain ratings during the BI and quantitative sensory testing at baseline and at 1, 2, 4, and 6 hours after the BI were performed. Quantitative sensory testing included assessments of secondary hyperalgesia areas, mechanical and thermal thresholds in the BI area, and pressure algometry. Furthermore, markers of inflammation, skin-reflectance spectrophotometry, and high-resolution ultrasonography were applied to measure skin erythema and dermal thickness in the BI area. Pain during the BI and secondary hyperalgesia areas were defined as primary outcomes. Twenty-nine volunteers were randomized and completed the study. While the BI induced large secondary hyperalgesia areas and significantly increased the markers of inflammation, no significant effects of melatonin were observed with respect to primary or secondary outcomes, compared with placebo. The administration of melatonin was not associated with any adverse effects. Melatonin did not demonstrate any analgesic, antihyperalgesic, or anti-inflammatory properties in the BI model. PMID:26164585

  14. A randomized cross-over study to compare PUVA and extracorporeal photopheresis in the treatment of plaque stage (T2) mycosis fungoides.

    PubMed

    Child, F J; Mitchell, T J; Whittaker, S J; Scarisbrick, J J; Seed, P T; Russell-Jones, R

    2004-05-01

    PUVA is a well-established and effective treatment for plaque stage mycosis fungoides (MF) but its use is limited on a long-term basis because of the risk of cutaneous carcinogenesis. A further disadvantage is that nonexposed areas (sanctuary sites) often develop persistent disease. Therefore it is important to find alternative methods of treatment. Extracorporeal photopheresis (ECP) is a form of photochemotherapy that involves exposure of white blood cells to UVA with psoralens and can be effective in Sézary syndrome and erythrodermic cutaneous T-cell lymphoma. The aim of this study was to compare the efficacy of PUVA and ECP in the treatment of patients with T2 plaque stage (Stage 1B) MF who had a detectable peripheral blood T-cell clone. The study was of a cross-over design. Sixteen patients were randomized to receive either PUVA twice weekly for 3 months followed by ECP once monthly for 6 months at relapse, or vice-versa. Response was assessed by monthly skin scores and peripheral blood T-cell clonality. Ten patients received PUVA initially and six ECP initially. Eight patients completed the study. Skin scores taken at the completion of each treatment arm in patients who completed the study were 113 units better (confidence interval, 42-184 units) following 3 months PUVA than 6 months ECP (P = 0.002). Peripheral blood T-cell clones were detectable in all patients post-treatment. This study indicates that ECP is not effective in the treatment of plaque stage (1B/T2) MF even in patients with molecular evidence of a peripheral blood T-cell clone. Although PUVA was more effective than ECP, neither treatment modality cleared malignant T-cells from the peripheral blood.

  15. Comparison of antianginal efficacy of nifedipine and isosorbide dinitrate in chronic stable angina: a long-term, randomized, double-blind, crossover study

    SciTech Connect

    Liang, C.S.; Coplin, B.; Wellington, K.

    1985-05-17

    Using a double-blind, crossover design, the comparative efficacy and safety of nifedipine and isosorbide dinitrate in the treatment of stable angina were studied in 34 patients. The study included a 2-week placebo washout period and two 6-week periods during which patients were randomized to either nifedipine or isosorbide dinitrate. The doses were titrated for each patient, and mean doses of the 2 drugs were comparable. A time-limited thallium treadmill test was performed at the end of each phase. Ischemic zone count rates were normalized to those of the nonischemic zone, and the change in this ratio with redistribution was calculated as reversible thallium defect. Two patients were discontinued from the study within 1 week after initiation of isosorbide dinitrate because of severe, intolerable headache. Two patients were withdrawn while receiving nifedipine: one had new congestive heart failure and the other had increasing angina. Of the remaining 30 patients who tolerated both drugs for at least 1 week, 4 patients from the isosorbide dinitrate group were either prematurely crossed over or discontinued from the study because of headache. One patient suffered headache from both drugs and was discontinued from the study. In the 30 patients, only nifedipine significantly reduced resting arterial pressure compared with baseline. Further, only nifedipine therapy resulted in significant decreases in the rate-pressure product and systolic pressure at a given workload. However, significant decreases in angina frequency, nitroglycerin consumption and exercise-induced maximum ST-segment depression and reversible thallium perfusion defect were produced by both nifedipine and isosorbide dinitrate.

  16. Comparison of the urinary excretion of quercetin glycosides from red onion and aglycone from dietary supplements in healthy subjects: a randomized, single-blinded, cross-over study.

    PubMed

    Shi, Yuanlu; Williamson, Gary

    2015-05-01

    Some intervention studies have shown that quercetin supplementation can regulate certain biomarkers, but it is not clear how the doses given relate to dietary quercetin (e.g. from onion). We conducted a two-period, two-sequence crossover study to compare the bioavailability of quercetin when administered in the form of a fresh red onion meal (naturally glycosylated quercetin) or dietary supplement (aglycone quercetin) under fasting conditions. Six healthy, non-smoking, adult males with BMI 22.7 ± 4.0 kg m(-2) and age 35.3 ± 12.3 y were grouped to take the two study meals in random order. In each of the 2 study periods, one serving of onion soup (made from 100 g fresh red onion, providing 156.3 ± 3.4 μmol (47 mg) quercetin) or a single dose of a quercetin dihydrate tablet (1800 ± 150 μmol (544 mg) of quercetin) were administered following 3 d washout. Urine samples were collected up to 24 h, and after enzyme deconjugation, quercetin was quantified by LC-MS. The 24 h urinary excretion of quercetin (1.69 ± 0.79 μmol) from red onion in soup was not significantly different to that (1.17 ± 0.44 μmol) for the quercetin supplement tablet (P = 0.065, paired t-test). This means that, in practice, 166 mg of quercetin supplement would be comparable to about 10 mg of quercetin aglycone equivalents from onion. These data allow intervention studies on quercetin giving either food or supplements to be more effectively compared.

  17. Analgesic and antihyperalgesic effects of melatonin in a human inflammatory pain model: a randomized, double-blind, placebo-controlled, three-arm crossover study.

    PubMed

    Andersen, Lars P H; Gögenur, Ismail; Fenger, Andreas Q; Petersen, Marian C; Rosenberg, Jacob; Werner, Mads U

    2015-11-01

    Antinociceptive effects of melatonin have been documented in a wide range of experimental animal models. The aim of this study was to investigate the analgesic, antihyperalgesic, and anti-inflammatory properties of melatonin using a validated burn injury (BI) model in healthy male volunteers. The design was a randomized, double-blind, placebo-controlled, three-arm crossover study. Each volunteer participated in 3 identical study sessions with intravenous administration of placebo, melatonin 10 mg, or melatonin 100 mg. Sixty minutes after bolus injection of study medication, a BI was induced by a computerized contact thermode (47.0°C, 420 seconds, 5.0 × 2.5 cm). Pain ratings during the BI and quantitative sensory testing at baseline and at 1, 2, 4, and 6 hours after the BI were performed. Quantitative sensory testing included assessments of secondary hyperalgesia areas, mechanical and thermal thresholds in the BI area, and pressure algometry. Furthermore, markers of inflammation, skin-reflectance spectrophotometry, and high-resolution ultrasonography were applied to measure skin erythema and dermal thickness in the BI area. Pain during the BI and secondary hyperalgesia areas were defined as primary outcomes. Twenty-nine volunteers were randomized and completed the study. While the BI induced large secondary hyperalgesia areas and significantly increased the markers of inflammation, no significant effects of melatonin were observed with respect to primary or secondary outcomes, compared with placebo. The administration of melatonin was not associated with any adverse effects. Melatonin did not demonstrate any analgesic, antihyperalgesic, or anti-inflammatory properties in the BI model.

  18. Postprandial effects on plasma lipids and satiety hormones from intake of liposomes made from fractionated oat oil: two randomized crossover studies

    PubMed Central

    Ohlsson, Lena; Rosenquist, Anna; Rehfeld, Jens F.; Härröd, Magnus

    2014-01-01

    Background The composition and surface structure of dietary lipids influence their intestinal degradation. Intake of liposomes made of fractionated oat oil (LOO) is suggested to affect the digestion process and postprandial lipemia and also induce satiety. Objective In the present study, the metabolic effects on plasma lipids and gut hormones related to satiety were investigated in healthy individuals after intake of LOO, with dairy lipids as placebo. Design Two blinded randomized studies with crossover design were performed. In the first study, 19 subjects consumed 35 g lipids from LOO or yoghurt in a breakfast meal. In a follow-up study, 15 women consumed 14 or 1.8 g lipids from LOO mixed in yoghurt. Blood samples were analyzed for plasma lipids, insulin, glucose, and intestinal hormones CCK, PYY, GLP-1, and GLP-2 before and four times after the meal. Subjective analysis of satiety was measured using a visual analog scale questionnaire. Participants recorded their food intake during the rest of the day. Results Intake of 35 and 14 g lipids from LOO significantly increased plasma concentrations of CCK, GLP-1, GLP-2, and PYY postprandially. This coincided with a prolonged elevation of triglycerides and large cholesterol-containing particles. Non-esterified fatty acids decreased after intake of 14 and 1.8 g lipids from LOO. The subjective sensation of satiety in women was increased 7 h after intake of 35 g lipids from LOO without any difference in food intake. Our results indicate that intake of 14 g lipids from LOO at breakfast substantially reduced energy intake during the rest of the day. Conclusions This study suggests that intake of LOO prolong lipid digestion, affect postprandial plasma lipids and have an effect on satiety. The effect of LOO on GLP-2 indicates that intake of LOO also improve gut health. PMID:25317122

  19. Zebrafish Caudal Fin Angiogenesis Assay—Advanced Quantitative Assessment Including 3-Way Correlative Microscopy

    PubMed Central

    Correa Shokiche, Carlos; Schaad, Laura; Triet, Ramona; Jazwinska, Anna; Tschanz, Stefan A.; Djonov, Valentin

    2016-01-01

    Background Researchers evaluating angiomodulating compounds as a part of scientific projects or pre-clinical studies are often confronted with limitations of applied animal models. The rough and insufficient early-stage compound assessment without reliable quantification of the vascular response counts, at least partially, to the low transition rate to clinics. Objective To establish an advanced, rapid and cost-effective angiogenesis assay for the precise and sensitive assessment of angiomodulating compounds using zebrafish caudal fin regeneration. It should provide information regarding the angiogenic mechanisms involved and should include qualitative and quantitative data of drug effects in a non-biased and time-efficient way. Approach & Results Basic vascular parameters (total regenerated area, vascular projection area, contour length, vessel area density) were extracted from in vivo fluorescence microscopy images using a stereological approach. Skeletonization of the vasculature by our custom-made software Skelios provided additional parameters including “graph energy” and “distance to farthest node”. The latter gave important insights into the complexity, connectivity and maturation status of the regenerating vascular network. The employment of a reference point (vascular parameters prior amputation) is unique for the model and crucial for a proper assessment. Additionally, the assay provides exceptional possibilities for correlative microscopy by combining in vivo-imaging and morphological investigation of the area of interest. The 3-way correlative microscopy links the dynamic changes in vivo with their structural substrate at the subcellular level. Conclusions The improved zebrafish fin regeneration model with advanced quantitative analysis and optional 3-way correlative morphology is a promising in vivo angiogenesis assay, well-suitable for basic research and preclinical investigations. PMID:26950851

  20. An Open-Label Randomized Crossover Trial of Lyophilized Black Raspberries on Postprandial Inflammation in Older Overweight Males: A Pilot Study.

    PubMed

    Sardo, Christine L; Kitzmiller, Joseph P; Apseloff, Glen; Harris, Robin B; Roe, Denise J; Stoner, Gary D; Jacobs, Elizabeth T

    2016-01-01

    This study was a 14-day, outpatient, open-label randomized crossover trial of lyophilized black raspberries (BRBs) in older overweight or obese males to determine whether BRB consumption affects postprandial inflammation associated with consumption of a high-fat high-calorie (HFHC) meal. Ten study participants consumed 45 g/d of lyophilized BRBs for 4 days, followed by a HFHC breakfast plus BRBs on day 6 or consumed the HFHC breakfast on day 6 without previous consumption of BRBs and then crossed over to the other treatment after a 2-day washout period. Blood samples were obtained before and 1, 2, 4, 8, and 12 hours after consumption of the HFHC breakfast. The primary study outcomes were changes in area under the concentration-time curve (AUC) for interleukin-6 (IL-6), C-reactive protein (CRP), and tumor necrosis factor-alpha (TNF-α). The secondary outcomes were safety and tolerability of lyophilized BRB powder. The chronology and values of measured serum concentrations for IL-6, TNF-α, and CRP were consistent with those described previously by other investigators. The AUC of serum IL-6 was lowered significantly (P = 0.03, n = 10) with BRB consumption (34.3 ± 7.6 pg·mL⁻¹·h⁻¹ compared with 42.4 ± 17.9 pg·mL⁻¹·h⁻¹ for consumption of the HFHC meal alone). However, no significant differences (change in AUC) were calculated for serum CRP and TNF-α. The findings of this pilot study suggest that consumption of lyophilized BRBs may attenuate postprandial inflammation in overweight or obese males consuming a HFHC meal. Further investigation of BRBs is warranted to better elucidate their inflammomodulatory potential.

  1. Effect of local heating on postprandial blood glucose excursions using the InsuPad device: results of an outpatient crossover study.

    PubMed

    Hermanns, Norbert; Bitton, Gabriel; Reimer, André; Krichbaum, Michael; Kulzer, Bernhard; Haak, Thomas

    2014-11-01

    The InsuPad is a medical device to accelerate insulin resorption by applying local heat at the insulin injection site. This crossover study examined the impact of the InsuPad use on postprandial glucose excursions under daily life conditions. In 1 study phase, diabetic patients used the InsuPad when injecting bolus insulin before breakfast and dinner and measured their blood glucose 5 times daily (before breakfast, lunch, and dinner and after breakfast and dinner). In the other study phase, blood glucose measurements were maintained without using the InsuPad. The order of the study phases was randomized. Twenty patients with a high insulin demand took part (30% type 1 diabetes, age 53.7 ± 8.9 years, diabetes duration 14.9 ± 7.4 years; HbA1c 8.3 ± 0.8%; total daily insulin demand 0.97 ± 0.32 IU per kg). Postprandial glucose excursion was reduced by 15.4 mg/dl (95% CI 9.7-21.2 mg/dl; P = .011) after breakfast and dinner if InsuPad was used. The mean blood glucose was lower by 8.8 mg/dl (95% CI 0:3-18:0 mg/dl; P = .099) when using the InsuPad. Safety parameters and the percentage of hypoglycemic (< 60 mg/dl) or hyperglycemic (> 300 mg/dl) blood glucose measurements were not negatively affected by InsuPad use (hypoglycemic values 1.4% vs 1.5%, P = .961; hyperglycemic values 2.6% vs 4.0%, P = .098). Local heating of the insulin injection site by use of the InsuPad device is an effective and safe method to reduce postprandial blood glucose excursions under daily life conditions without negative side effects on the occurrence of low or high blood glucose values. PMID:25113814

  2. Unexpected Inflammatory Effects of Intravaginal Gels (Universal Placebo Gel and Nonoxynol-9) on the Upper Female Reproductive Tract: A Randomized Crossover Study

    PubMed Central

    Smith-McCune, Karen; Chen, Joseph C.; Greenblatt, Ruth M.; Shanmugasundaram, Uma; Shacklett, Barbara L.; Hilton, Joan F.; Johnson, Brittni; Irwin, Juan C.; Giudice, Linda C

    2015-01-01

    Intravaginal anti-HIV microbicides could provide women with a self-controlled means for HIV prevention, but results from clinical trials have been largely disappointing. We postulated that unrecognized effects of intravaginal gels on the upper female reproductive tract might contribute to the lower-than-expected efficacy of HIV microbicides. Our objective was to study the effects of intravaginal gels on the immune microenvironment of the cervix and uterus. In this randomized crossover study, 27 healthy female volunteers used a nightly application of intravaginal nonoxynol-9 (N9) gel as a “failed” microbicide or the universal placebo gel (UPG) as a “safe” gel (intervention cycles), or nothing (control cycle) from the end of menses to the mid-luteal phase. At a specific time-point following ovulation, all participants underwent sample collection for measurements of T-cell phenotypes, gene expression, and cytokine/chemokine protein concentrations from 3 anatomic sites above the vagina: the cervical transformation zone, the endocervix and the endometrium. We used hierarchical statistical models to estimate mean (95% CI) intervention effects, for N9 and UPG relative to control. Exposure to N9 gel and UPG generated a common “harm signal” that included transcriptional up-regulation of inflammatory genes chemokine (C-C motif) ligand 20 (macrophage inflammatory factor-3alpha) and interleukin 8 in the cervix, decreased protein concentrations of secretory leukocyte protease inhibitor, and transcriptional up-regulation of inflammatory mediators glycodelin-A and osteopontin in the endometrium. These results need to be replicated with a larger sample, but underscore the need to consider the effects of microbicide agents and gel excipients on the upper female reproductive tract in studies of vaginal microbicides. PMID:26177352

  3. Evaluation of inhaler handling-errors, inhaler perception and preference with Spiromax, Easyhaler and Turbuhaler devices among healthy Finnish volunteers: a single site, single visit crossover study (Finhaler)

    PubMed Central

    Sandler, Niklas; Holländer, Jenny; Långström, Disa; Santtila, Pekka; Saukkonen, Anni; Torvinen, Saku

    2016-01-01

    Introduction Correct inhaler technique and device preference are positively correlated with improved adherence and clinical outcomes. This study was designed to investigate inhaler technique mastery and device preference for three different dry powder inhalers, Spiromax, Easyhaler and Turbuhaler. Methods This was a single site, single visit, crossover study assessing device mastery, handling errors and preference using empty Spiromax, Easyhaler and Turbuhaler devices in healthy adult Finnish volunteers. Inhaler naïve adult participants were observed by healthcare professionals (HCPs) to evaluate the proportion of participants achieving device mastery (defined as an absence of HCP observed errors) using a three-step approach: (1) intuitive use (with no instructions), (2) after reading the patient information leaflet and (3) after HCP instruction. HCPs monitored and recorded errors based on device-specific handling error checklists. At the end of the study, participants completed a device preference questionnaire and rated their satisfaction with the three devices. Results Spiromax was correctly used by 37.5% and 93.3% of participants in steps 1 and 2, respectively, compared with 0% and 58.3% with Easyhaler, and 9.2% and 76.7% with Turbuhaler. All three devices showed high mastery (>95%) in step 3. The most common error reported with Spiromax was related to the orientation of the device. Not shaking the device was the most common error with Easyhaler. Errors in priming the device were the most common with Turbuhaler. Spiromax, Easyhaler and Turbuhaler were rated as the ‘easiest device to use’ by 73.1%, 12.6% and 14.3% of participants, respectively. The HCP instructions clearly improved the use of all devices. Conclusion Higher levels of device mastery, including intuitive/ease of use, were reported by naïve users when using Spiromax compared with Easyhaler and Turbuhaler. PMID:27026804

  4. Has the short-term effect of black smoke exposure on pneumonia mortality been underestimated because hospitalisation is ignored: findings from a case-crossover study

    PubMed Central

    2013-01-01

    Background Short-term associations have been demonstrated between air pollution and respiratory mortality including pneumonia. Studies typically estimate exposure based only on place of residence, yet many are in hospital prior to death. This study investigates lag length and tests the hypothesis that the effect of 'black smoke’ is greater when restricted to pneumonia deaths in the community – Community Deaths from Pneumonia. Methods A time-stratified case-crossover design using conditional logistic regression estimated the daily percentage increase in risk of pneumonia mortality in relation to 'black smoke’ in the preceding 30 days. Cases were pneumonia deaths in Edinburgh 1981–1996. Multiple 'control’ periods, were defined using the same weekdays for the same month as the case death. Lag structure was investigated by a stratified lag model with five 6-day periods and by distributed lag models. Hospital admissions data, defined a community death as someone who had not been in hospital in any of the 30 days before death. Results Of 14,346 subjects who died from pneumonia, 7,536 were community deaths. Larger estimated increases in risks were seen in the community for all lag periods. Both stratified and distributed lag methods suggested positive effect estimates for 18 days after exposure and negative thereafter; the average percent increase per day across the 18 days was 0.70% (95% C.I. 0.29-1.14) for community subjects and 0.30% (95% C.I. 0.03-0.59) for all subjects. Conclusions Studies which fail to account for hospitalisation may underestimate exposure effects as stronger pollution effects on mortality were evident in community based subjects. PMID:24199609

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

    PubMed Central

    2013-01-01

    Objective Probiotic and synbiotic products are widely marketed to healthy individuals, although potential benefits for these individuals are rarely studied. This study investigated the effect of daily consumption of a synbiotic yogurt on gastrointestinal (GI) function in a sample of healthy adults. Subjects/Methods In a randomized crossover double-blind study, 65 healthy adults consumed 200 g/day of yogurt with (synbiotic) or without (control) added probiotics (Bifidobacterium lactis Bb12, Lactobacillus acidophilus La5, Lactobacillus casei CRL431) and 4 g inulin for two 15-day treatment periods, each preceded by a 6-week washout period. GI transit time (GTT), duration of colour (DOC), GI symptoms and dietary intake were assessed and analyzed using repeated measures ANOVA, including PRE-treatment GTT as a covariate. Participants were grouped as short GTT (STT, n = 50, ≤32.7 h) or long GTT (LTT, n = 15, >32.7 h) based on their PRE-treatment GTT assessment. Results POST-treatment GTT and DOC were not different between synbiotic and control, and did not change from PRE-treatment, within the STT or LTT groups. There were no changes in GI symptom ratings, indicating that both yogurts were well tolerated. In STT, energy, fat and protein intakes were decreased from baseline with synbiotic (p = 0.055, p = 0.059 and p = 0.005, respectively) and dietary fibre intake was higher POST-treatment with synbiotic versus control (p = 0.0002). In LTT, decreases in energy and fat intakes with synbiotic were not significant (p = 0.14 and p = 0.18, respectively) and there were no differences in dietary fibre intake. Conclusion Consuming 200 g/day of synbiotic yogurt did not significantly alter GTT in healthy adults, but was well tolerated and helped to reduce overall energy intake. PMID:23787118

  6. Unexpected Inflammatory Effects of Intravaginal Gels (Universal Placebo Gel and Nonoxynol-9) on the Upper Female Reproductive Tract: A Randomized Crossover Study.

    PubMed

    Smith-McCune, Karen; Chen, Joseph C; Greenblatt, Ruth M; Shanmugasundaram, Uma; Shacklett, Barbara L; Hilton, Joan F; Johnson, Brittni; Irwin, Juan C; Giudice, Linda C

    2015-01-01

    Intravaginal anti-HIV microbicides could provide women with a self-controlled means for HIV prevention, but results from clinical trials have been largely disappointing. We postulated that unrecognized effects of intravaginal gels on the upper female reproductive tract might contribute to the lower-than-expected efficacy of HIV microbicides. Our objective was to study the effects of intravaginal gels on the immune microenvironment of the cervix and uterus. In this randomized crossover study, 27 healthy female volunteers used a nightly application of intravaginal nonoxynol-9 (N9) gel as a "failed" microbicide or the universal placebo gel (UPG) as a "safe" gel (intervention cycles), or nothing (control cycle) from the end of menses to the mid-luteal phase. At a specific time-point following ovulation, all participants underwent sample collection for measurements of T-cell phenotypes, gene expression, and cytokine/chemokine protein concentrations from 3 anatomic sites above the vagina: the cervical transformation zone, the endocervix and the endometrium. We used hierarchical statistical models to estimate mean (95% CI) intervention effects, for N9 and UPG relative to control. Exposure to N9 gel and UPG generated a common "harm signal" that included transcriptional up-regulation of inflammatory genes chemokine (C-C motif) ligand 20 (macrophage inflammatory factor-3alpha) and interleukin 8 in the cervix, decreased protein concentrations of secretory leukocyte protease inhibitor, and transcriptional up-regulation of inflammatory mediators glycodelin-A and osteopontin in the endometrium. These results need to be replicated with a larger sample, but underscore the need to consider the effects of microbicide agents and gel excipients on the upper female reproductive tract in studies of vaginal microbicides. PMID:26177352

  7. Comment on ?Spin crossover in (Mg,Fe)O: A M?ssbauer effect study with an alternative interpretation of x-ray emission spectroscopy data?

    SciTech Connect

    Lin, J; Struzhkin, V V; Garriliuk, A

    2006-05-23

    Electronic spin-pairing transition of iron in magnesiow{umlt u}stite-(Mg,Fe)O has been recently studied with X-ray emission and M{umlt o}ssbauer spectroscopies under high pressures. While these studies reported a high-spin to low-spin transition of iron to occur at pressures above approximately 50 GPa, the width of the observed transition varies significantly. In particular, Kantor et al. reported that the transition in (Mg0.8,Fe0.2)O occurs over a pressure range of approximately 50 GPa in high-pressure M{umlt o}ssbauer measurements. To account for the discrepancy in the transition pressure, Kantor et al. reanalyzed the X-ray emission spectra by Lin et al. using a simple spectral decomposition method and claimed that X-ray emission measurements are also consistent with a spin crossover of iron at high pressures. Here we show that the proposed fitting method is inadequate to describe the X-ray emission spectrum of the low-spin FeS2 and would give an erroneous satellite peak (K{sub beta}') intensity, leading to an artificial high-spin component and, consequently, to invalid conclusions regarding the width of the pressure-induced transition in magnesiow{umlt u}stite. Furthermore, we compare Kantor's M{umlt o}ssbauer data with other recent high-pressure M{umlt o}ssbauer studies and show that the width of the transition can be simply explained by different experimental conditions (sample thickness, diameter, and hydrostaticity).

  8. The effect of intranasal oxytocin versus placebo treatment on the autonomic responses to human sounds in autism: a single-blind, randomized, placebo-controlled, crossover design study

    PubMed Central

    2014-01-01

    Background Many individuals with autism spectrum disorders (ASD) have difficulty with verbal communication, which might be due to a lack of spontaneous orientation toward social auditory stimuli. Previous studies have shown that a single dose of oxytocin improves speech comprehension in autism. The primary aim of this study was to investigate whether the orientation behaviors toward human sounds are different for neurotypical (NT) adults and adults with ASD and whether oxytocin has an effect on their orientation behaviors toward human sounds. Methods This was a randomized, placebo-controlled, within-subject, crossover design study of intranasal oxytocin versus placebo in 13 NT adults and 16 adults with ASD. Subjects were randomized to 24 IU intranasal oxytocin or placebo on different days, and they were blind to the treatment. The participants then listened passively to human and non-human affective sounds while their skin conductance responses (SCRs) and the changes in peripheral blood vessel constriction were monitored as an indicator of spontaneous orientation. The monitored data were analyzed by a mixed-design ANOVA. Results Oxytocin enhanced the difference between the SCRs to human and non-human sounds in both the NT and ASD groups (F(1,56) = 6.046, p = 0.017). Further correlation coefficient analysis showed significant correlations between this SCR difference and the scores in the autism spectrum quotient ‘attention to detail’ and ‘social skill’ subscales and interpersonal reactivity index and social functioning scale in the ASD group. Oxytocin was well tolerated, and no serious adverse effects were reported. Conclusions The difference in SCRs implies that oxytocin nasal spray may enhance orientation behaviors toward human sounds in the presence of other environmental sounds in both ASD and NT adults. Trial registration UMIN-CTR Clinical Trial, Unique trial number: UMIN000005809 PMID:24576333

  9. Universal Entanglement Crossover of Coupled Quantum Wires

    NASA Astrophysics Data System (ADS)

    Vasseur, Romain; Jacobsen, Jesper Lykke; Saleur, Hubert

    2014-03-01

    We consider the entanglement between two one-dimensional quantum wires (Luttinger liquids) coupled by tunneling through a quantum impurity. The physics of the system involves a crossover between weak and strong coupling regimes characterized by an energy scale TB, and methods of conformal field theory therefore cannot be applied. The evolution of the entanglement in this crossover has led to many numerical studies, but has remained little understood, analytically or even qualitatively. We argue in this Letter that the correct universal scaling form of the entanglement entropy S (for an arbitrary interval of length L containing the impurity) is ∂S/∂ ln L=f(LTB). In the special case where the coupling to the impurity can be refermionized, we show how the universal function f(LTB) can be obtained analytically using recent results on form factors of twist fields and a defect massless-scattering formalism. Our results are carefully checked against numerical simulations.

  10. Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Lisdexamfetamine Dimesylate in College Students with ADHD

    ERIC Educational Resources Information Center

    DuPaul, George J.; Weyandt, Lisa L.; Rossi, Joseph S.; Vilardo, Brigid A.; O'Dell, Sean M.; Carson, Kristen M.; Verdi, Genevieve; Swentosky, Anthony

    2012-01-01

    Objective: To evaluate stimulant medication on symptoms and functioning for college students with ADHD using double-blind, placebo-controlled, crossover design. Method: Participants included 24 college students with ADHD and 26 college students without psychopathology. Lisdexamfetamine dimesylate (LDX) was examined for ADHD participants over five…

  11. Amisulpride versus Bromocriptine in Infantile Autism: A Controlled Crossover Comparative Study of Two Drugs with Opposite Effects on Dopaminergic Function.

    ERIC Educational Resources Information Center

    Dollfus, Sonia; And Others

    1992-01-01

    This study compared the clinical efficacy of a dopaminergic antagonist (amisulpride) and a dopaminergic agonist (bromocriptine) with 9 children (ages 4-13) with autism and probable severe mental retardation. The amisulpride acted preferentially on specific autism symptoms and the bromocriptine on motor hyperactivity and attention symptoms.…

  12. Spin-Crossover Molecular Solids Beyond Rigid Crystal Approximation

    NASA Astrophysics Data System (ADS)

    Gudyma, Iurii V.; Ivashko, Victor V.

    2016-04-01

    The qualitative analysis of the spin-crossover molecular solid with distortion effect is presented. A spin-crossover solid with effect of distortion is studied in the framework of the Ising-like model with two-order parameters under statistical approach, where the effect of elastic strain on inter-ion interaction is considered. These considerations lead to examination of the relation between the primary and secondary order parameters during temperature and pressure changes.

  13. Spin-Crossover Molecular Solids Beyond Rigid Crystal Approximation.

    PubMed

    Gudyma, Iurii V; Ivashko, Victor V

    2016-12-01

    The qualitative analysis of the spin-crossover molecular solid with distortion effect is presented. A spin-crossover solid with effect of distortion is studied in the framework of the Ising-like model with two-order parameters under statistical approach, where the effect of elastic strain on inter-ion interaction is considered. These considerations lead to examination of the relation between the primary and secondary order parameters during temperature and pressure changes. PMID:27075338

  14. Patient satisfaction with complete dentures fabricated using two neutral zone techniques: a within-subject cross-over pilot study.

    PubMed

    Ladha, Komal; Gupta, Rekha; Gill, Shubhra; Verma, Mahesh

    2014-06-01

    Several studies have compared complete dentures fabricated using conventional and neutral zone (NZ) techniques. However, studies comparing patient satisfaction with complete dentures fabricated using swallowing and phonetic NZ techniques are lacking in literature. To compare patient satisfaction with the complete dentures fabricated using the two NZ techniques. To compare the bucco-lingual dimensions of the NZ records obtained with these techniques. Ten completely edentulous subjects dissatisfied with their existing mandibular complete dentures participated in the study. Five subjects first received the swallowing neutral zone (SNZ) dentures and five the phonetic neutral zone (PNZ) dentures. Tissue conditioner was used as the recording material in both the techniques. After having worn the prosthesis for a minimum of 2 months, subjects responded to a questionnaire that measured their perceptions of various factors associated with the prosthesis. The prostheses were then changed and the procedures repeated. Student t test and non-parametric Mann-Whitney tests were used for statistical analysis. Level of statistical significance was set p < 0.05. There was no statistical significant difference in patient satisfaction with the SNZ and PNZ complete dentures for all the variables assessed. Statistical significant difference was observed for majority of the variables when the two NZ dentures were compared with patients' old dentures. The difference in the mean dimensions of the two NZ records was also found to be statistically insignificant except in the maxillary left premolar region. The study indicated that patient satisfaction with the complete dentures fabricated using SNZ technique did not significantly differ from that of the PNZ technique. Data gathered at the final appointment showed that SNZ dentures were preferred by the patients with regards to esthetics, stability, comfort and ability to chew. For ability to speak, mixed preferences were found.

  15. Restricting night-time eating reduces daily energy intake in healthy young men: a short-term cross-over study.

    PubMed

    LeCheminant, James D; Christenson, Ed; Bailey, Bruce W; Tucker, Larry A

    2013-12-14

    Few experimental data are available to support the notion that reducing night-time eating changes total daily energy intake (EI) or body weight in healthy adults. The present study primarily examined the short-term effect of night eating restriction (NER) on daily EI in healthy young men. It secondarily examined body weight and moods associated with NER. Using a cross-over design, twenty-nine men (20·9 (sd 2·5) years; 24·4 (sd 2·5) kg/m²) initiated a 2-week NER intervention (elimination of EI from 19.00 to 06.00 hours) and a 2-week control condition, counterbalanced and separated by a 1-week washout period. EI and macronutrient intake were assessed using computerised, multiple-pass 24 h food recalls, body weight via a digital scale and mood using the Profile of Mood States survey. Of the twenty-nine participants, twenty-seven (93 %) completed all aspects of the study. During the NER condition, the participants consumed less total energy per d than during the control condition (10 125 v. 11 146 kJ/d; F= 6·41; P= 0·018). During the NER condition, no energy was reported consumed between 19.00 and 06.00 hours; however, during the control condition, the energy intake of participants was 2920 (sd 1347) kJ/d between 19.00 and 06.00 hours. There was a significant difference in weight change between the NER (-0·4 (sd 1·1) kg) and control (+0·6 (sd 0·9) kg) conditions (F= 22·68; P< 0·001). Differences in total mood score or mood subscales between the NER and control conditions were not apparent (P>0·05). These findings provide support for NER decreasing short-term EI in healthy young men.

  16. Direct bandgap cross-over point of Ge1-ySny grown on Si estimated through temperature-dependent photoluminescence studies

    NASA Astrophysics Data System (ADS)

    Harris, Thomas R.; Ryu, Mee-Yi; Yeo, Yung Kee; Wang, Buguo; Senaratne, C. L.; Kouvetakis, John

    2016-08-01

    Epitaxial Ge1-ySny (y = 0%-7.5%) alloys grown on either Si or Ge-buffered Si substrates by chemical vapor deposition were studied as a function of Sn content using temperature-dependent photoluminescence (PL). PL emission peaks from both the direct bandgap (Γ-valley) and the indirect bandgap (L-valley) to the valence band (denoted by ED and EID, respectively) were clearly observed at 125 and 175 K for most Ge1-ySny samples studied. At 300 K, however, all of the samples exhibited dominant ED emission with either very weak or no measureable EID emission. At 10 K, ED is dominant only for Ge1-ySny with y > 0.052. From the PL spectra taken at 125 and 175 K, the unstrained indirect and direct bandgap energies were calculated and are plotted as a function of Sn concentration, the results of which show that the indirect-to-direct bandgap transition occurs at ˜6.7% Sn. It is believed that the true indirect-to-direct bandgap cross-over of unstrained Ge1-ySny might also take place at about the same Sn content at room temperature. This observation suggests that these Ge1-ySny alloys could become very promising direct bandgap semiconductor materials, which will be very useful for the development of various new novel Si- and Ge-based infrared optoelectronic devices that can be fully integrated with current technology on a single Si chip.

  17. Death of a Close Relative and the Risk of Suicide in Sweden—A Large Scale Register-Based Case-Crossover Study

    PubMed Central

    Mogensen, Hanna; Möller, Jette; Hultin, Hanna; Mittendorfer-Rutz, Ellenor

    2016-01-01

    Background Bereavement is thought to be a risk factor for suicide but the association has not been thoroughly investigated according to specific sensitive time periods and risk groups using a self-matched design. We aimed to 1) determine the risk of suicide within the first year after death of a close relative, 2) investigate if and how the risk changes within this time window and 3) determine if sex, age, and type of relationship, affect this association. Methods A self-matched, case-crossover study was performed by linking Swedish registers. In total, 31 059 individuals with suicide between 1990 and 2011 were included. Different periods within the year prior to the suicide were compared with corresponding periods one year earlier in the same individual’s life. Conditional logistic regression was used to calculate odds ratios (OR) and 95% confidence intervals (CI) for suicide after death of a close relative. Results Increased ORs of suicide were seen during the first month, OR 1·77 (95% CI 1·35–2·34), and the first half-year, 1·27 (1·13–1·43). An even higher OR was found within the first week, 3·43 (1·89–6·22). Patterns were similar for women and men and across age groups. Death of a partner or child but not death of a sibling or parent was associated with a significantly increased suicide risk. The strongest association was seen after death of a partner in individuals aged 45 and older. Discussion These findings provide knowledge of sensitive time periods and at-risk groups in the early period of bereavement. Due to the use of a self-matched study design, methodological challenges of unmeasured residual confounding could be overcome. PMID:27727324

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

    PubMed Central

    Jakobsen, Ida; Solomon, Thomas P. J.

    2016-01-01

    Interval-type exercise is effective for improving glycemic control, but the optimal approach is unknown. The purpose of this study was to determine the importance of the interval length on changes in postprandial glycemic control following a single exercise bout. Twelve subjects with type 2 diabetes completed a cross-over study with three 1-hour interventions performed in a non-randomized but counter-balanced order: 1) Interval walking consisting of repeated cycles of 3 min slow (aiming for 54% of Peak oxygen consumption rate [VO2peak]) and 3 min fast (aiming for 89% of VO2peak) walking (IW3); 2) Interval walking consisting of repeated cycles of 1 min slow and 1 min fast walking (IW1) and 3) No walking (CON). The exercise interventions were matched with regards to walking speed, and VO2 and heart rate was assessed throughout all interventions. A 4-hour liquid mixed meal tolerance test commenced 30 min after each intervention, with blood samples taken regularly. IW3 and IW1 resulted in comparable mean VO2 and heart rates. Overall mean postprandial blood glucose levels were lower after IW3 compared to CON (10.3±3.0 vs. 11.1±3.3 mmol/L; P < 0.05), with no significant differences between IW1 (10.5±2.8 mmol/L) and CON or IW3 and IW1 (P > 0.05 for both). Conversely blood glucose levels at specific time points during the MMTT differed significantly following both IW3 and IW1 as compared to CON. Our findings support the previously found blood glucose lowering effect of IW3 and suggest that reducing the interval length, while keeping the walking speed and time spend on fast and slow walking constant, does not result in additional improvements. Trial Registration ClinicalTrials.gov NCT02257190 PMID:27695119

  19. OROS-methylphenidate efficacy on specific executive functioning deficits in adults with ADHD: a randomized, placebo-controlled cross-over study.

    PubMed

    Bron, Tannetje I; Bijlenga, Denise; Boonstra, A Marije; Breuk, Minda; Pardoen, Willem F H; Beekman, Aartjan T F; Kooij, J J Sandra

    2014-04-01

    Attention-deficit/hyperactivity disorder (ADHD) is linked to impaired executive functioning (EF). This is the first study to objectively investigate the effects of a long-acting methylphenidate on neurocognitive test performance of adults with ADHD. Twenty-two adults with ADHD participated in a 6-weeks study examining the effect of osmotic-release oral system methylphenidate (OROS-mph) on continuous performance tests (CPTs; objective measures), and on the self-reported ADHD rating scale (subjective measure) using a randomized, double-blind, placebo-controlled cross-over design. OROS-mph significantly improved reaction time variability (RTV), commission errors (CE) and d-prime (DP) as compared to baseline (Cohen's d>.50), but did not affect hit reaction time (HRT) or omission errors (OE). Compared to placebo, OROS-mph only significantly influenced RTV on one of two CPTs (p<.050). Linear regression analyses showed predictive ability of more beneficial OROS-mph effects in ADHD patients with higher EF severity (RTV: β=.670, t=2.097, p=.042; omission errors (OE): β=-.098, t=-4.759, p<.001), and with more severe ADHD symptoms (RTV: F=6.363, p=.019; HRT: F=3.914, p=.061). Side effects rates were substantially but non-significantly greater for OROS-mph compared to placebo (77% vs. 46%, p=.063). OROS-mph effects indicated RTV as the most sensitive parameter for measuring both neuropsychological and behavioral deficits in adults with ADHD. These findings suggest RTV as an endophenotypic parameter for ADHD symptomatology, and propose CPTs as an objective method for monitoring methylphenidate titration. PMID:24508533

  20. Bioavailability and inter-conversion of sulforaphane and erucin in human subjects consuming broccoli sprouts or broccoli supplement in a cross-over study design

    PubMed Central

    Clarke, John D.; Hsu, Anna; Riedl, Ken; Bella, Deborah; Schwartz, Steven J.; Stevens, Jan F.; Ho, Emily

    2011-01-01

    Broccoli consumption may reduce the risk of various cancers and many broccoli supplements are now available. The bioavailability and excretion of the mercapturic acid pathway metabolites isothiocyanates after human consumption of broccoli supplements has not been tested. Two important isothiocyanates from broccoli are sulforaphane and erucin. We employed a cross-over study design in which 12 subjects consumed 40 grams of fresh broccoli sprouts followed by a 1 month washout period and then the same 12 subjects consumed 6 pills of a broccoli supplement. As negative controls for isothiocyanate consumption four additional subjects consumed alfalfa sprouts during the first phase and placebo pills during the second. Blood and urine samples were collected for 48 hours during each phase and analyzed for sulforaphane and erucin metabolites using LC-MS/MS. The bioavailability of sulforaphane and erucin is dramatically lower when subjects consume broccoli supplements compared to fresh broccoli sprouts. The peaks in plasma concentrations and urinary excretion were also delayed when subjects consumed the broccoli supplement. GSTP1 polymorphisms did not affect the metabolism or excretion of sulforaphane or erucin. Sulforaphane and erucin are able to interconvert in vivo and this interconversion is consistent within each subject but variable between subjects. This study confirms that consumption of broccoli supplements devoid of myrosinase activity does not produce equivalent plasma concentrations of the bioactive isothiocyanate metabolites compared to broccoli sprouts. This has implications for people who consume the recommended serving size (1 pill) of a broccoli supplement and believe they are getting equivalent doses of isothiocyanates. PMID:21816223

  1. Xanthophylls, phytosterols and pre-β1-HDL are differentially affected by fenofibrate and niacin HDL-raising in a cross-over study.

    PubMed

    Niesor, Eric J; Gauthamadasa, Kekulawalage; Silva, R A Gangani D; Suchankova, Gabriela; Kallend, David; Gylling, Helena; Asztalos, Bela; Damonte, Elisabetta; Rossomanno, Simona; Abt, Markus; Davidson, W Sean; Benghozi, Renee

    2013-12-01

    Fenofibrate and extended-release (ER) niacin similarly raise high-density lipoprotein cholesterol (HDL-C) concentration but their effects on levels of potent plasma antioxidant xanthophylls (lutein and zeaxanthin) and phytosterols obtained from dietary sources, and any relationship with plasma lipoproteins and pre-β1-HDL levels, have not been investigated. We studied these parameters in 66 dyslipidemic patients treated for 6 week with fenofibrate (160 mg/day) or ER-niacin (0.5 g/day for 3 week, then 1 g/day) in a cross-over study. Both treatments increased HDL-C (16 %) and apolipoprotein (apo) A-I (7 %) but only fenofibrate increased apoA-II (28 %). Lutein and zeaxanthin levels were unaffected by fenofibrate but inversely correlated with percentage change in apoB and low-density lipoprotein cholesterol and positively correlated with end of treatment apoA-II. ApoA-II in isolated HDL in vitro bound more lutein than apoA-I. Xanthophylls were increased by ER-niacin (each ~30 %) without any correlation to lipoprotein or apo levels. Only fenofibrate markedly decreased plasma markers of cholesterol absorption; pre-β1-HDL was significantly decreased by fenofibrate (-19 %, p < 0.0001), with little change (3.4 %) for ER-niacin. Although fenofibrate and ER-niacin similarly increased plasma HDL-C and apoA-I, effects on plasma xanthophylls, phytosterols and pre-β1-HDL differed markedly, suggesting differences in intestinal lipidation of HDL. In addition, the in vitro investigations suggest an important role of plasma apoA-II in xanthophyll metabolism.

  2. Antipsychotic Drugs and the Risk of Ventricular Arrhythmia and/or Sudden Cardiac Death: A Nation‐wide Case‐Crossover Study

    PubMed Central

    Wu, Chi‐Shin; Tsai, Yu‐Ting; Tsai, Hui‐Ju

    2015-01-01

    Background Antipsychotics have been linked to prolongation of the QT interval. However, little is known about the risk of ventricular arrhythmia (VA) and/or sudden cardiac death (SCD) associated with individual antipsychotic drug use. This study was designed to investigate the association between specific antipsychotic drugs and the risk of VA and/or SCD. Methods and Results We conducted a case‐crossover study using a nation‐wide population‐based sample obtained from Taiwan's National Health Insurance Research Database. A total of 17 718 patients with incident VA and/or SCD were enrolled. Conditional logistic regression models were applied to examine the effects of antipsychotic drug use on the risk of VA/SCD during various case and control time windows of 7, 14, and 28 days. The effect of the potency of a human ether‐à‐go‐go‐related gene (hERG) potassium channel blockade was also assessed. Antipsychotic drug use was associated with a 1.53‐fold increased risk of VA and/or SCD. Antipsychotic drugs with increased risk included clothiapine, haloperidol, prochlorperazine, thioridazine, olanzapine, quetiapine, risperidone, and sulpiride. The association was significantly higher among those with short‐term use. Antipsychotics with a high potency of the hERG potassium channel blockade had the highest risk of VA and/or SCD. Conclusion Use of antipsychotic drugs is associated with an increased risk of VA and/or SCD. Careful evaluations of the risks and benefits of antipsychotic treatment are highly recommended. PMID:25713294

  3. Sodium bicarbonate supplementation improved MAOD but is not correlated with 200- and 400-m running performances: a double-blind, crossover, and placebo-controlled study.

    PubMed

    Brisola, Gabriel Motta Pinheiro; Miyagi, Willian Eiji; da Silva, Henrique Santos; Zagatto, Alessandro Moura

    2015-09-01

    The aim of the study was to investigate the effects of acute supplementation of sodium bicarbonate (NaHCO3) on maximal accumulated oxygen deficit (MAOD) determined by a single supramaximal effort (MAODALT) in running and the correlation with 200- and 400-m running performances. Fifteen healthy men (age, 23 ± 4 years; maximal oxygen uptake, 50.6 ± 6.1 mL·kg(-1)·min(-1)) underwent a maximal incremental exercise test and 2 supramaximal efforts at 110% of the intensity associated with maximal oxygen uptake, which was carried out after ingesting either 0.3 g·kg(-1) body weight NaHCO3 or a placebo (dextrose) and completing 200- and 400-m performance tests. The study design was double-blind, crossover, and placebo-controlled. Significant differences were found between the NaHCO3 and placebo conditions for MAODALT (p = 0.01) and the qualitative inference for substantial changes showed a very likely positive effect (98%). The lactic anaerobic contribution in the NaHCO3 ingestion condition was significantly higher (p < 0.01) and showed a very likely positive effect (99% chance), similar to that verified for peak blood lactate concentration (p < 0.01). No difference was found for time until exhaustion (p = 0.19) or alactic anaerobic contribution (p = 0.81). No significant correlations were observed between MAODALT and 200- and 400-m running performance tests. Therefore, we can conclude that both MAODALT and the anaerobic lactic metabolism are modified after acute NaHCO3 ingestion, but it is not correlated with running performance.

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

    PubMed

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

    2016-10-01

    Hypertension is a major risk factor for cardiovascular disease and has a prevalence of about one billion people worldwide. It has been shown that adherence to a diet rich in fruits and vegetables helps in decreasing blood pressure (BP). This study aimed to investigate the effect of raw beet juice (RBJ) and cooked beet (CB) on BP of hypertensive subjects. In this randomized crossover study, 24 hypertensive subjects aged 25-68 years old were divided into two groups. One group took RBJ for 2 weeks and the other group took CB. After 2 weeks of treatment, both groups had a washout for 2 weeks then switched to the alternate treatment. Each participant consumed 250 ml day(-1) of RBJ or 250 g day(-1) of CB each for a period of 2 weeks. Body weight, BP, flow-mediated dilation (FMD), lipid profile and inflammatory parameters were measured at baseline and after each period. According to the results, high-sensitivity C-reactive protein (hs-CRP) and tumour necrosis factor alpha (TNF-α) were significantly lower and FMD was significantly higher after treatment with RBJ compared with CB (P<0.05). FMD was significantly (P<0.05) increased, but systolic and diastolic BP, intracellular adhesion molecule-1 (ICAM-1), vascular endothelial adhesion molecule-1 (VCAM-1), hs-CRP, interleukin-6, E-selectin and TNF-α were significantly (P<0.05) decreased with RBJ or CB. Total antioxidant capacity was increased and non-high-density lipoprotein (HDL), low-density lipoprotein (LDL) and total cholesterol (TC) were decreased with RBJ but not with CB. Although both forms of beetroot were effective in improving BP, endothelial function and systemic inflammation, the raw beetroot juice had greater antihypertensive effects. Also more improvement was observed in endothelial function and systemic inflammation with RBJ compared with CB. PMID:27278926

  5. Eating buckwheat cookies is associated with the reduction in serum levels of myeloperoxidase and cholesterol: a double blind crossover study in day-care centre staffs.

    PubMed

    Wieslander, Gunilla; Fabjan, Nina; Vogrincic, Maja; Kreft, Ivan; Janson, Christer; Spetz-Nyström, Ulrike; Vombergar, Blanka; Tagesson, Christer; Leanderson, Per; Norbäck, Dan

    2011-01-01

    Buckwheat food is a good source of antioxidants, e.g. rutin, and other beneficial substances. Here we investigated the effects of the intake of common buckwheat (low rutin content) and tartary buckwheat cookies (high rutin content) on selected clinical markers. A double blind crossover study was performed among female day-care centre staffs (N = 62) from five day-care centres. Participants were randomly divided into two groups. The first group initially consumed four common buckwheat cookies per day (16.5 mg rutin equivalents/day) for two weeks, while the second group consumed four tartary buckwheat cookies per day (359.7 mg rutin equivalents/day). Then the groups switched their type of cookies and consumed them for another two weeks. We monitored selected clinical markers related to cardiovascular disease and lower airway inflammation, lung function, and subjective breathing difficulties in the staffs. Intake of tartary buckwheat cookies reduced the serum level of myeloperoxidase (MPO) by a factor 0.84 (p = 0.02). When grouping the two types of buckwheat cookies together, there was a reduction of total serum cholesterol (p < 0.001) and HDL-cholesterol (p < 0.001) during the study period, with improved lung vital capacity (p < 0.001). The degree of reduction in total and HDL cholesterol levels was similar in staffs with low and high body mass index (cut off 25). In conclusion, intake of tartary buckwheat cookies with high level of the antioxidant rutin may reduce levels of MPO, an indicator of inflammation. Moreover, intake of both types of buckwheat cookies may lower cholesterol levels.

  6. A randomized, crossover pharmacodynamic study of immediate-release omeprazole/sodium bicarbonate and delayed-release lansoprazole in healthy adult volunteers.

    PubMed

    Pratha, Vijayalakshmi S; McGraw, Thomas; Tobin, William

    2016-06-01

    Proton pump inhibitors (PPIs) effectively block gastric acid secretion and are the treatment of choice for heartburn. PPIs differ, however, in onset of action and bioavailability. In this single-center, open-label, three-way crossover study, onset of action of immediate-release omeprazole 20 mg/sodium bicarbonate 1100 mg (IR-OME) and delayed-release (DR) lansoprazole 15 mg was evaluated in 63 healthy fasting adults. Subjects were randomized to once daily IR-OME, or DR-lansoprazole, or no treatment for 7 days. The primary efficacy endpoint was the earliest time where a statistically significant difference was observed between IR-OME and DR-lansoprazole in median intragastric pH scores for three consecutive 5-min intervals on day 7. Secondary endpoints compared effects of active treatments on days 1 and 7 (e.g., time to sustained inhibition, percentage of time with pH >4). A significant difference in median intragastric pH favoring IR-OME was observed on day 7 starting at the 10- to 15-min interval postdosing (P = 0.024) and sustaining through the 115- to 120-min interval (P = 0.017). On day 1, IR-OME achieved sustained inhibition of intragastric acidity significantly faster than DR-lansoprazole. IR-OME maintained pH >4 significantly longer than DR-lansoprazole over a 24-h period (P = 0.007) on day 7. Overall, results of this study demonstrate IR-OME is safe and well tolerated and that treatment with IR-OME results in significantly faster onset of action and better gastric acid suppression at steady state than DR-lansoprazole. PMID:27433347

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

    PubMed

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

    2016-10-01

    Hypertension is a major risk factor for cardiovascular disease and has a prevalence of about one billion people worldwide. It has been shown that adherence to a diet rich in fruits and vegetables helps in decreasing blood pressure (BP). This study aimed to investigate the effect of raw beet juice (RBJ) and cooked beet (CB) on BP of hypertensive subjects. In this randomized crossover study, 24 hypertensive subjects aged 25-68 years old were divided into two groups. One group took RBJ for 2 weeks and the other group took CB. After 2 weeks of treatment, both groups had a washout for 2 weeks then switched to the alternate treatment. Each participant consumed 250 ml day(-1) of RBJ or 250 g day(-1) of CB each for a period of 2 weeks. Body weight, BP, flow-mediated dilation (FMD), lipid profile and inflammatory parameters were measured at baseline and after each period. According to the results, high-sensitivity C-reactive protein (hs-CRP) and tumour necrosis factor alpha (TNF-α) were significantly lower and FMD was significantly higher after treatment with RBJ compared with CB (P<0.05). FMD was significantly (P<0.05) increased, but systolic and diastolic BP, intracellular adhesion molecule-1 (ICAM-1), vascular endothelial adhesion molecule-1 (VCAM-1), hs-CRP, interleukin-6, E-selectin and TNF-α were significantly (P<0.05) decreased with RBJ or CB. Total antioxidant capacity was increased and non-high-density lipoprotein (HDL), low-density lipoprotein (LDL) and total cholesterol (TC) were decreased with RBJ but not with CB. Although both forms of beetroot were effective in improving BP, endothelial function and systemic inflammation, the raw beetroot juice had greater antihypertensive effects. Also more improvement was observed in endothelial function and systemic inflammation with RBJ compared with CB.

  8. The effect of lactose-isomaltulose-containing growing-up milks on cognitive performance of Indonesian children: a cross-over study.

    PubMed

    Sekartini, Rini; Wiguna, Tjhin; Bardosono, Saptawati; Novita, Dian; Arsianti, Tiana; Calame, Wim; Schaafsma, Anne

    2013-09-28

    Glycaemic response to dietary carbohydrates might have an impact on cognitive performance. The present study investigated the effects of growing-up milks (GUM) with isomaltulose and extra minerals and vitamins or lower protein content on cognitive parameters in children aged 5–6 years. In a blinded, partly randomised, controlled, cross-over study, four GUM were provided, each taken over 14 d (2 × 200 ml/d): standard (Std) GUM; Std GUM+5 g isomaltulose (Iso-5 GUM); Iso-5 GUM with 26 % less protein (Iso-5 LP GUM); Std GUM with 2·5 g isomaltulose and extra Mg, Zn, Se, D3, B1, B2, B12, folic acid and choline (Iso-2·5 GUM). At test days, when GUM replaced breakfast, repeated (0, 60, 120 and 180 min post-dose) cognitive tasks were performed (picture presentation, simple reaction time, digit vigilance, choice reaction time, spatial and numeric working memory and picture recognition). Task performance of all subjects (n 50) worsened over the morning. Best performance was seen on isomaltulose GUM, most notably at 180 min. Iso-2·5 GUM showed best performance on several parameters of attention and memory, Iso-5 GUM performed best on parameters of memory and Iso-5 LP GUM was positively associated with parameters of attention but less with memory. Std GUM showed only a benefit on one attention and one memory task. Thus, isomaltulose-enriched GUM positively affected parameters of attention and memory at 180 min post-dose when compared with Std GUM. Extra minerals and vitamins seem beneficial, whereas lowering protein content might improve attention in particular.

  9. Cardiovascular responses to the ingestion of sugary drinks using a randomised cross-over study design: Does glucose attenuate the blood pressure-elevating effect of fructose?

    PubMed

    Grasser, Erik K; Dulloo, Abdul; Montani, Jean-Pierre

    2014-07-28

    Overconsumption of sugar-sweetened beverages has been implicated in the pathogenesis of CVD. The objective of the present study was to elucidate acute haemodynamic and microcirculatory responses to the ingestion of sugary drinks made from sucrose, glucose or fructose at concentrations similar to those often found in commercial soft drinks. In a randomised cross-over study design, twelve young healthy human subjects (seven men) ingested 500 ml tap water in which was dissolved 60 g of either sucrose, glucose or fructose, or an amount of fructose equivalent to that present in sucrose (i.e. 30 g fructose). Continuous cardiovascular monitoring was performed for 30 min before and at 60 min after ingestion of sugary drinks, and measurements included beat-to-beat blood pressure (BP) and impedance cardiography. Additionally, microvascular endothelial function testing was performed after iontophoresis of acetylcholine and sodium nitroprusside using laser Doppler flowmetry. Ingestion of fructose (60 or 30 g) increased diastolic and mean BP to a greater extent than the ingestion of 60 g of either glucose or sucrose (P< 0.05). Ingestion of sucrose and glucose increased cardiac output (CO; P< 0.05), index of contractility (P< 0.05) and stroke volume (P< 0.05), but reduced total peripheral resistance (TPR; P< 0.05), which contrasts with the tendency of fructose (60 and 30 g) to increase resistance. Microvascular endothelial function did not differ in response to the ingestion of various sugary drinks. In conclusion, ingestion of fructose, but not sucrose, increases BP in healthy human subjects. Although sucrose comprises glucose and fructose, its changes in TPR and CO are more related to glucose than to fructose. PMID:24780643

  10. Cardiovascular responses to the ingestion of sugary drinks using a randomised cross-over study design: Does glucose attenuate the blood pressure-elevating effect of fructose?

    PubMed

    Grasser, Erik K; Dulloo, Abdul; Montani, Jean-Pierre

    2014-07-28

    Overconsumption of sugar-sweetened beverages has been implicated in the pathogenesis of CVD. The objective of the present study was to elucidate acute haemodynamic and microcirculatory responses to the ingestion of sugary drinks made from sucrose, glucose or fructose at concentrations similar to those often found in commercial soft drinks. In a randomised cross-over study design, twelve young healthy human subjects (seven men) ingested 500 ml tap water in which was dissolved 60 g of either sucrose, glucose or fructose, or an amount of fructose equivalent to that present in sucrose (i.e. 30 g fructose). Continuous cardiovascular monitoring was performed for 30 min before and at 60 min after ingestion of sugary drinks, and measurements included beat-to-beat blood pressure (BP) and impedance cardiography. Additionally, microvascular endothelial function testing was performed after iontophoresis of acetylcholine and sodium nitroprusside using laser Doppler flowmetry. Ingestion of fructose (60 or 30 g) increased diastolic and mean BP to a greater extent than the ingestion of 60 g of either glucose or sucrose (P< 0.05). Ingestion of sucrose and glucose increased cardiac output (CO; P< 0.05), index of contractility (P< 0.05) and stroke volume (P< 0.05), but reduced total peripheral resistance (TPR; P< 0.05), which contrasts with the tendency of fructose (60 and 30 g) to increase resistance. Microvascular endothelial function did not differ in response to the ingestion of various sugary drinks. In conclusion, ingestion of fructose, but not sucrose, increases BP in healthy human subjects. Although sucrose comprises glucose and fructose, its changes in TPR and CO are more related to glucose than to fructose.

  11. The efficacy of Xialine in patients with Sjögren's syndrome: a single-blind, cross-over study.

    PubMed

    Alpöz, Esin; Güneri, Pelin; Onder, Gonca; Cankaya, Hülya; Kabasakal, Yasemin; Köse, Timur

    2008-06-01

    Sjögren syndrome (SS) is a chronic inflammatory autoimmune disease of unknown cause whose main characteristic is severe dryness of the eyes and the mouth. The decreased functional capacity of the lacrimal and salivary glands which is the result of the inflammatory process and lymphocytic infiltration observed in SS is accountable for this complication. Twenty-nine patients with SS whose ages were ranging between 24-77, who were under treatment in Ege University Faculty of Medicine Department of Rheumatology, participated in the study, and their informed consents were obtained upon enrollment. Each patient recorded their subjective complaints on a separate questionnaire. The baseline and subsequent evaluation of the subjective findings on predetermined times (1 h after application of the material, at the end of the 1st, 7th, and 14th days) were also recorded on separate questionnaire sheets. Throughout the 14-day treatment period, no statistically significant differences were noted between the Xialine and placebo groups with regard to burning tongue, diminished taste, and waking up at night to sip water (p = 0.925, 0.527, and 0.066, respectively). However, patients' satisfaction with placebo decreased by 25.63% at the end of the test period, whereas it increased by 16.37% after Xialine administration. Overall, the patients preferred Xialine at the end of the study (p = 0.011). The main motive to administer saliva substitute is to improve lubrication and hydration of oral tissues. The results of this study indicated that Xialine is helpful in the management of xerostomia-related symptoms of SS patients. However, further investigations in larger scale group of patients are recommended to provide the effects of these agents on various complaints of xerostomia.

  12. The Clinical Efficacy of Mometasone Furoate in Multi-Lamellar Emulsion for Eczema: A Double-blinded Crossover Study

    PubMed Central

    Kim, Duk Han; Lee, Hyun Jong; Park, Chun Wook; Kim, Kyu Han; Lee, Kwang Hoon; Ro, Byung In

    2013-01-01

    Background Topical application of corticosteroids also has an influence on skin barrier impairment. Physiological lipid mixtures, such as multi-lamellar emulsion (MLE) containing a natural lipid component leads to effective recovery of the barrier function. Objective The purpose of this study was to conduct an evaluation of the therapeutic efficacy and skin barrier protection of topical mometasone furoate in MLE. Methods A multi-center randomized, double-blind, controlled study was performed to assess the efficacy and safety of mometasone furoate cream in MLE for Korean patients with eczema. The study group included 175 patients with eczema, who applied either mometasone furoate in MLE cream or methylprednisolone aceponate cream for 2 weeks. Treatment efficacy was evaluated using the physician's global assessment of clinical response (PGA), trans-epidermal water loss (TEWL), and visual analogue scale (VAS) for pruritus. Patients were evaluated using these indices at days 4, 8, and 15. Results Comparison of PGA score, TEWL, and VAS score at baseline with those at days 4, 8, and 15 of treatment showed a significant improvement in both groups. Patients who applied mometasone furoate in MLE (74.8%) showed better results (p<0.05) than those who applied methylprednisolone aceponate (47.8%). The TEWL improvement ratio was higher in the mometasone furoate in MLE group than that in the methylprednisolone aceponate group, and VAS improvement was also better in the mometasone furoate in MLE group. Conclusion Mometasone furoate in MLE has a better therapeutic efficacy as well as less skin barrier impairment than methylprednisolone aceponate. PMID:23467551

  13. Aortic arch replacement with a beating heart: a simple method using continuous 3-way perfusion.

    PubMed

    Abu-Omar, Y; Ali, J M; Colah, S; Dunning, J J

    2014-01-01

    We describe a simplified 3-way perfusion strategy that could be used in complex aortic procedures, which ensures continuous end-organ perfusion and minimizes the potential risks of cardiac, cerebral and peripheral ischaemic complications.

  14. A placebo-controlled crossover study of iloperidone augmentation for residual anger and irritability in major depressive disorder

    PubMed Central

    Ionescu, Dawn F.; Fava, Maurizio; Kim, Daniel Ju Hyung; Baer, Lee; Shelton, Richard C.; Cusin, Cristina

    2016-01-01

    Background: Even when patients experience remission with antidepressants, many continue to report anger attacks and excessive irritability despite continued treatment. Iloperidone antagonizes 5-HT-2a, D2, and alpha-1 receptors, which can have anti-aggressive effects. We examined iloperidone’s safety and efficacy as an augmentation agent in outpatients with partially remitted major depressive disorder (MDD) with residual symptoms of anger and irritability. Methods: A total of 13 outpatients with partially remitted MDD [currently treated with selective serotonin reuptake inhibitors (SSRIs)] received four weeks of iloperidone or placebo, followed by one week of washout. Patients were then crossed over to the other treatment arm for 4 weeks. Treatment arms were randomized and double blind; and two sites were used for the study. Analyses compared treatment response using the Symptom Questionnaire (SQ) Anger/Hostility Subscale as the primary outcome measure. Results: There was no significant differential effect of iloperidone × weeks on the SQ Anger/Hostility Subscore over the course of the study, compared with placebo × weeks, regardless of administration order (p = 0.77). Conclusions: Iloperidone did not significantly outperform placebo on measures of anger or irritability in patients with partially remitted MDD and residual anger/irritability. PMID:26913173

  15. Are There Side Effects to Watching 3D Movies? A Prospective Crossover Observational Study on Visually Induced Motion Sickness

    PubMed Central

    Solimini, Angelo G.

    2013-01-01

    Background The increasing popularity of commercial movies showing three dimensional (3D) images has raised concern about possible adverse side effects on viewers. Methods and Findings A prospective carryover observational study was designed to assess the effect of exposure (3D vs. 2D movie views) on self reported symptoms of visually induced motion sickness. The standardized Simulator Sickness Questionnaire (SSQ) was self administered on a convenience sample of 497 healthy adult volunteers before and after the vision of 2D and 3D movies. Viewers reporting some sickness (SSQ total score>15) were 54.8% of the total sample after the 3D movie compared to 14.1% of total sample after the 2D movie. Symptom intensity was 8.8 times higher than baseline after exposure to 3D movie (compared to the increase of 2 times the baseline after the 2D movie). Multivariate modeling of visually induced motion sickness as response variables pointed out the significant effects of exposure to 3D movie, history of car sickness and headache, after adjusting for gender, age, self reported anxiety level, attention to the movie and show time. Conclusions Seeing 3D movies can increase rating of symptoms of nausea, oculomotor and disorientation, especially in women with susceptible visual-vestibular system. Confirmatory studies which include examination of clinical signs on viewers are needed to pursue a conclusive evidence on the 3D vision effects on spectators. PMID:23418530

  16. 3-way Networks: Application of Hypergraphs for Modelling Increased Complexity in Comparative Genomics

    DOE PAGES

    Weighill, Deborah A.; Jacobson, Daniel A.

    2015-03-27

    Herein we present and develop the theory of 3-way networks, a type of hypergraph in which each edge models relationships between triplets of objects as opposed to pairs of objects as done by standard network models. We explore approaches of how to prune these 3-way networks, illustrate their utility in comparative genomics and demonstrate how they find relationships which would be missed by standard 2-way network models using a phylogenomic dataset of 211 bacterial genomes.

  17. Objective assessment of drowsiness and reaction time during intermittent Ramadan fasting in young men: a case-crossover study

    PubMed Central

    2013-01-01

    Background Ramadan fasting and its attendant lifestyle changes induce changes in the circadian rhythm and in associated physiological and metabolic functions. Previous studies that have assessed psychomotor performance during Ramadan fasting have reported conflicting results. Therefore, we designed this study to objectively assess the effects of intermittent fasting during and outside Ramadan (to control for lifestyle changes) on drowsiness, blink total duration and mean reaction time (MRT) test while controlling for potential confounders. Methods Eight healthy volunteers with a mean age of 25.3 ± 2.9 years and a mean body mass index (BMI) of 23.4 ± 3.2 kg/m2 reported to the sleep laboratory on four occasions for polysomnography (PSG) and drowsiness and psychomotor assessments as follows: 1) adaptation; 2) 4 weeks before Ramadan while performing the Islamic fasting for 1 week (baseline fasting) (BLF); 3) 1 week before Ramadan (non-fasting baseline) (BL); and 4) during the second week of Ramadan while fasting (Ramadan). OPTALERT™ was used to objectively assess daytime drowsiness using the Johns Drowsiness Scale (JDS), and blink total duration and a visual reaction time test were used to assess MRT. Results Rapid eye movement (REM) sleep percentage was significantly lower at BLF (17.7 ± 8.1%) and at Ramadan (18.6 ± 10.7%) compared with BL (25.6 ± 4.8%) (p < 0.05). There were no significant differences between JDS scores and blink total duration during the two test periods in BL, BLF and Ramadan. There were no significant changes in MRT during BL, BLF and Ramadan. Conclusions Under controlled conditions of fixed light/dark exposure, caloric intake, sleep/wake schedule and sleep quality, the Islamic intermittent fasting has no impact on drowsiness and vigilance as measured by the JDS, total blink duration and MRT. PMID:23937904

  18. Acute effects of exposure to a traditional rural environment on urban dwellers: a crossover field study in terraced farmland.

    PubMed

    Lee, Juyoung; Park, Bum-Jin; Ohira, Tatsuro; Kagawa, Takahide; Miyazaki, Yoshifumi

    2015-02-05

    Despite an increasing attention and public preference for rural amenities, little evidence is available on the health benefits of a rural environment. In this study, we identified physiological and psychological benefits of exposure to a rural environment using multiparametric methods. Twelve young male adults participated in a 3-day field experiment (mean ± standard deviation age, 22.3 ± 1.3 years). Sleeping environment, diet program, physical activities, and other factors possibly affecting physiological responses were controlled during experiment period. For all participants, salivary cortisol concentration, heart rate variability, and blood pressure were measured at rural and urban field sites. Self-evaluation questionnaires were administered to analyze the psychological states in two different environments. Volatile compounds in the air were also analyzed to investigate air quality. The data were compared between rural and urban environments. The data showed that exposure to a rural environment reduced stress hormone secretion and sympathetic nervous activity and increased parasympathetic nervous activity. Short-term exposure to a rural environment also improved mood states. Our findings indicate that exposure to a rural environment effectively reduced physiological stress and enhanced psychological well-being.

  19. The role of water in protein's behavior: The two dynamical crossovers studied by NMR and FTIR techniques

    PubMed Central

    Mallamace, Francesco; Corsaro, Carmelo; Mallamace, Domenico; Vasi, Sebastiano; Vasi, Cirino; Dugo, Giacomo

    2014-01-01

    The role the solvent plays in determining the biological activity of proteins is of primary importance. Water is the solvent of life and proteins need at least a water monolayer covering their surface in order to become biologically active. We study how the properties of water and the effect of its coupling with the hydrophilic moieties of proteins govern the regime of protein activity. In particular we follow, by means of Fourier Transform Infrared spectroscopy, the thermal evolution of the amide vibrational modes of hydrated lysozyme in the temperature interval 180 K < T < 350 K. In such a way we are able to observe the thermal limit of biological activity characterizing hydrated lysozyme. Finally we focus on the region of lysozyme thermal denaturation by following the evolution of the proton Nuclear Magnetic Resonance (NMR) spectra for 298 K < T < 366 K with the High-Resolution Magic Angle Spinning probe. Our data suggest that the hydrogen bond coupling between hydration water and protein hydrophilic groups is crucial in triggering the main mechanisms that define the enzymatic activity of proteins. PMID:25750698

  20. The role of water in protein's behavior: The two dynamical crossovers studied by NMR and FTIR techniques.

    PubMed

    Mallamace, Francesco; Corsaro, Carmelo; Mallamace, Domenico; Vasi, Sebastiano; Vasi, Cirino; Dugo, Giacomo

    2015-01-01

    The role the solvent plays in determining the biological activity of proteins is of primary importance. Water is the solvent of life and proteins need at least a water monolayer covering their surface in order to become biologically active. We study how the properties of water and the effect of its coupling with the hydrophilic moieties of proteins govern the regime of protein activity. In particular we follow, by means of Fourier Transform Infrared spectroscopy, the thermal evolution of the amide vibrational modes of hydrated lysozyme in the temperature interval 180 K < T < 350 K. In such a way we are able to observe the thermal limit of biological activity characterizing hydrated lysozyme. Finally we focus on the region of lysozyme thermal denaturation by following the evolution of the proton Nuclear Magnetic Resonance (NMR) spectra for 298 K < T < 366 K with the High-Resolution Magic Angle Spinning probe. Our data suggest that the hydrogen bond coupling between hydration water and protein hydrophilic groups is crucial in triggering the main mechanisms that define the enzymatic activity of proteins.

  1. Noninvasive Mechanical Ventilation Improves Breathing-Swallowing Interaction of Ventilator Dependent Neuromuscular Patients: A Prospective Crossover Study

    PubMed Central

    Garguilo, Marine; Lejaille, Michèle; Vaugier, Isabelle; Orlikowski, David; Terzi, Nicolas; Lofaso, Frédéric; Prigent, Hélène

    2016-01-01

    Background Respiratory involvement in neuromuscular disorders may contribute to impaired breathing-swallowing interactions, swallowing disorders and malnutrition. We investigated whether the use of non-invasive ventilation (NIV) controlled by the patient could improve swallowing performances in a population of neuromuscular patients requiring daytime NIV. Methods Ten neuromuscular patients with severe respiratory failure requiring extensive NIV use were studied while swallowing without and with NIV (while ventilated with a modified ventilator allowing the patient to withhold ventilation as desired). Breathing-swallowing interactions were investigated by chin electromyography, cervical piezoelectric sensor, nasal flow recording and inductive plethysmography. Two water-bolus sizes (5 and 10ml) and a textured yogurt bolus were tested in a random order. Results NIV use significantly improved swallowing fragmentation (defined as the number of respiratory interruption of the swallowing of a single bolus) (p = 0.003) and breathing-swallowing synchronization (with a significant increase of swallows followed by an expiration) (p <0.0001). Patient exhibited piecemeal swallowing which was not influenced by NIV use (p = 0.07). NIV use also significantly reduced dyspnea during swallowing (p = 0.04) while preserving swallowing comfort, regardless of bolus type. Conclusion The use of patient controlled NIV improves swallowing parameters in patients with severe neuromuscular respiratory failure requiring daytime NIV, without impairing swallowing comfort. Trial Registration ClinicalTrials.gov NCT01519388 PMID:26938617

  2. Acute Effects of Exposure to a Traditional Rural Environment on Urban Dwellers: A Crossover Field Study in Terraced Farmland

    PubMed Central

    Lee, Juyoung; Park, Bum-Jin; Ohira, Tatsuro; Kagawa, Takahide; Miyazaki, Yoshifumi

    2015-01-01

    Despite an increasing attention and public preference for rural amenities, little evidence is available on the health benefits of a rural environment. In this study, we identified physiological and psychological benefits of exposure to a rural environment using multiparametric methods. Twelve young male adults participated in a 3-day field experiment (mean ± standard deviation age, 22.3 ± 1.3 years). Sleeping environment, diet program, physical activities, and other factors possibly affecting physiological responses were controlled during experiment period. For all participants, salivary cortisol concentration, heart rate variability, and blood pressure were measured at rural and urban field sites. Self-evaluation questionnaires were administered to analyze the psychological states in two different environments. Volatile compounds in the air were also analyzed to investigate air quality. The data were compared between rural and urban environments. The data showed that exposure to a rural environment reduced stress hormone secretion and sympathetic nervous activity and increased parasympathetic nervous activity. Short-term exposure to a rural environment also improved mood states. Our findings indicate that exposure to a rural environment effectively reduced physiological stress and enhanced psychological well-being. PMID:25664697

  3. Microelectronic superconducting crossover and coil

    DOEpatents

    Wellstood, F.C.; Kingston, J.J.; Clarke, J.

    1994-03-01

    A microelectronic component comprising a crossover is provided comprising a substrate, a first high T[sub c] superconductor thin film, a second insulating thin film comprising SrTiO[sub 3]; and a third high T[sub c] superconducting film which has strips which crossover one or more areas of the first superconductor film. An in situ method for depositing all three films on a substrate is provided which does not require annealing steps and which can be opened to the atmosphere between depositions. 13 figures.

  4. The BCS-BEC Crossover

    NASA Astrophysics Data System (ADS)

    Parish, Meera M.

    2015-09-01

    This chapter presents the crossover from the Bardeen-Cooper-Schrieffer (BCS) state of weakly correlated pairs of fermions to the Bose-Einstein condensation (BEC) of diatomic molecules in the atomic Fermi gas. Our aim is to provide a pedagogical review of the BCS-BEC crossover, with an emphasis on the basic concepts, particularly those that are not generally known or are difficult to find in the literature. We shall not attempt to give an exhaustive survey of current research in the limited space here; where possible, we will direct the reader to more extensive reviews.

  5. The effect of rizatriptan, ergotamine, and their combination on human peripheral arteries: a double-blind, placebo-controlled, crossover study in normal subjects

    PubMed Central

    Tfelt-Hansen, Peer; Seidelin, Kaj; Stepanavage, Michael; Lines, Christopher

    2002-01-01

    Aims To compare the peripheral vasoconstrictor effects of ergotamine, rizatriptan, and their combination, in normal subjects. Methods This was a double-blind, four-way, crossover study. Sixteen young male volunteers, selected as responders to the vasoconstrictor effect of 0.5 mg ergotamine i.v., were administered 10 mg oral rizatriptan, 0.25 mg i.v. ergotamine, 10 mg oral rizatriptan +0.25 mg i.v. ergotamine, and placebo. The vasoconstrictor effect on peripheral arteries was measured with strain gauge plethysmography up to 8 h after dosing. The 8 h assessment period was divided into two 4 h intervals to assess the immediate (0–4 h) vs sustained effect (4–8 h) of treatment. Results For the 0–4 h interval, the decreases in peripheral systolic blood pressure gradients were: placebo (−1 mmHg [95% CI: −3, 1])

  6. A randomized crossover study comparing trehalose/hyaluronate eyedrops and standard treatment: patient satisfaction in the treatment of dry eye syndrome.

    PubMed

    Pinto-Bonilla, Juan Carlos; Del Olmo-Jimeno, Alberto; Llovet-Osuna, Fernando; Hernández-Galilea, Emiliano

    2015-01-01

    Dry eye is a common disorder in routine ophthalmological practice, and a better understanding of the complex pathophysiology is leading to improved treatment. Thealoz Duo(®) is a novel artificial tear preparation containing two active ingredients: Trehalose, a naturally occurring disaccharide with anhydrobiotic functions in many organisms, and hyaluronate, a widely distributed anionic glycosaminoglycan polysaccharide with lubricative and water-retaining properties in biological systems. In a randomized, single center, open label, crossover study, 17 adult patients with moderate-to-severe dry eye syndrome were randomized to treatment with Thealoz Duo(®) (combining trehalose and hyaluronic acid) or Systane(®). Patients received 7 days of treatment. The primary efficacy variable was patient satisfaction evaluated by a 0-100 visual analog scale evaluated on days 0 and 7 of treatment. Secondary parameters included ocular surface disease index (OSDI), symptoms of dry eye, ocular staining scores (fluorescein and lissamine green), ocular clinical signs, Schirmer test, tear breakup time, and global efficacy assessed by the patient and the investigator. Seventeen patients were included. Patient satisfaction improved from 44.5±19.0 to 70.2±19.2 mm during Thealoz Duo(®) treatment and from 47.2±23 to 57.1±19.1 mm during Systane(®) treatment (P=0.043, mixed-effects analysis of covariance). Two secondary efficacy parameters (dry eye symptoms and the impact of their symptoms on work) showed statistically significant advantages for Thealoz Duo(®) over Systane(®). There were no statistically significant advantages for Systane(®) over Thealoz Duo(®) for any measured parameter. No adverse events were reported. Thealoz Duo(®) appears to be an effective combination of two active ingredients for the treatment of dry eye and is at least as effective as Systane(®).

  7. Comparison between Steroid Injection and Stretching Exercise on the Scalene of Patients with Upper Extremity Paresthesia: Randomized Cross-Over Study

    PubMed Central

    Kim, Yong Wook; Yoon, Seo Yeon; Park, Yongbum; Chang, Won Hyuk

    2016-01-01

    Purpose To compare the therapeutic effects on upper extremity paresthesia of intra-muscular steroid injections into the scalene muscle with those of stretching exercise only. Materials and Methods Twenty patients with upper extremity paresthesia who met the criteria were recruited to participate in this single-blind, crossover study. Fourteen of 20 patients were female. The average age was 45.0±10.5 years and duration of symptom was 12.2±8.7 months. Each participant completed one injection and daily exercise program for 2 weeks. After randomization, half of all patients received ultrasound-guided injection of scalene muscles before exercise, while the other was invested for the other patients. Results After two weeks, there was a significant decrease of the visual analog scale score of treatment effect compared with baseline in both groups (6.90 to 2.85 after injection and 5.65 to 4.05 after stretching exercise, p<0.01). However, injection resulted in greater improvements than stretching exercise (p<0.01). The number of patients with successful treatment, defined as >50% reduction in post-treatment visual analog scale, was 18 of 20 (90.0%) after injection, compared to 5 of 20 (25.0%) after stretching exercise. There were no cases of unintended brachial plexus block after injection. Conclusion Ultrasound-guided steroid injection or stretching exercise of scalene muscles led to reduced upper extremity paresthesia in patients who present with localized tenderness in the scalene muscle without electrodiagnostic test abnormalities, although injection treatment resulted in more improvements. The results suggest that symptoms relief might result from injection into the muscle alone not related to blockade of the brachial plexus. PMID:26847305

  8. Articaine and mepivacaine buccal infiltration in securing mandibular first molar pulp anesthesia following mepivacaine inferior alveolar nerve block: A randomized, double-blind crossover study

    PubMed Central

    Gazal, Giath; Alharbi, Abdullah Muteb; Al-Samadani, Khalid HidayatAllah; Kanaa, Mohammad Dib

    2015-01-01

    Aims: A crossover double-blind, randomized study was designed to explore the efficacy of 2% mepivacaine with 1:100,000 adrenaline buccal infiltration and 4% articaine with 1:100,000 adrenaline buccal infiltration following 2% mepivacaine with 1:100,000 adrenaline inferior alveolar nerve block (IANB) for testing pulp anesthesia of mandibular first molar teeth in adult volunteers. Materials and Methods: A total of 23 healthy adult volunteers received two regimens with at least 1-week apart; one with 4% articaine buccal infiltration and 2% mepivacaine IANB (articaine regimen) and another with 2% mepivacaine buccal infiltration supplemented to 2% mepivacaine IANB (mepivacaine regimen). Pulp testing of first molar tooth was electronically measured twice at baseline, then at intervals of 2 min for the first 10 min, then every 5 min until 45 min postinjection. Anesthetic success was considered when two consecutive maximal stimulation on pulp testing readings without sensation were obtained within 10 min and continuously sustained for 45 min postinjection. Results: In total, the number of no sensations to maximum pulp testing for first molar teeth were significantly higher after articaine regimen than mepivacaine during 45 min postinjection (267 vs. 250 episodes, respectively, P < 0.001), however, both articaine and mepivacaine buccal infiltrations are equally effective in securing anesthetic success for first molar pulp anesthesia when supplemented to mepivacaine IANB injections (P > 0.05). Interestingly, volunteers in the articaine regimen provided faster onset and longer duration (means 2.78 min, 42.22 min, respectively) than mepivacaine regimen (means 4.26 min, 40.74 min, respectively) for first molar pulp anesthesia (P < 0.001). Conclusions: Supplementary mepivacaine and articaine buccal infiltrations produced similar successful first molar pulp anesthesia following mepivacaine IANB injections in volunteers. Articaine buccal infiltration produced faster onset and

  9. No evidence of dehydration with moderate daily coffee intake: a counterbalanced cross-over study in a free-living population.

    PubMed

    Killer, Sophie C; Blannin, Andrew K; Jeukendrup, Asker E

    2014-01-01

    It is often suggested that coffee causes dehydration and its consumption should be avoided or significantly reduced to maintain fluid balance. The aim of this study was to directly compare the effects of coffee consumption against water ingestion across a range of validated hydration assessment techniques. In a counterbalanced cross-over design, 50 male coffee drinkers (habitually consuming 3-6 cups per day) participated in two trials, each lasting three consecutive days. In addition to controlled physical activity, food and fluid intake, participants consumed either 4×200 mL of coffee containing 4 mg/kg caffeine (C) or water (W). Total body water (TBW) was calculated pre- and post-trial via ingestion of Deuterium Oxide. Urinary and haematological hydration markers were recorded daily in addition to nude body mass measurement (BM). Plasma was analysed for caffeine to confirm compliance. There were no significant changes in TBW from beginning to end of either trial and no differences between trials (51.5±1.4 vs. 51.4±1.3 kg, for C and W, respectively). No differences were observed between trials across any haematological markers or in 24 h urine volume (2409±660 vs. 2428±669 mL, for C and W, respectively), USG, osmolality or creatinine. Mean urinary Na(+) excretion was higher in C than W (p = 0.02). No significant differences in BM were found between conditions, although a small progressive daily fall was observed within both trials (0.4±0.5 kg; p<0.05). Our data show that there were no significant differences across a wide range of haematological and urinary markers of hydration status between trials. These data suggest that coffee, when consumed in moderation by caffeine habituated males provides similar hydrating qualities to water. PMID:24416202

  10. Increased Risk of End-Stage Renal Disease (ESRD) Requiring Chronic Dialysis is Associated With Use of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Nationwide Case-Crossover Study.

    PubMed

    Chang, Yu-Kang; Liu, Jia-Sin; Hsu, Yueh-Han; Tarng, Der-Cherng; Hsu, Chih-Cheng

    2015-09-01

    It is known that many medical adverse events can be caused by nonsteroidal anti-inflammatory drugs (NSAIDs); however, epidemiologic evidence has not granted an affirmative relationship between NSAID use and the risk of end-stage renal disease (ESRD). We aimed to investigate the relationship in a Chinese population between short-term NSAID use and development of ESRD requiring chronic dialysis. A retrospective case-crossover design was used in this study. Using the Taiwanese National Health Insurance database, we identified 109,400 incident chronic ESRD patients with dialysis initiation from 1998 to 2009. For each patient, we defined the case period as 1 to 14 days and the control period as 105 to 118 days, respectively, before the first dialysis date. The washout period was 90 days between the case and control period. Detailed information about NSAID use was compared between the case and control periods. We calculated odds ratios (ORs) and their 95% confidence intervals (CIs) using a conditional logistic regression model. NSAID use was found to be a significant risk factor associated with dialysis commencement. The adjusted OR was 2.73 (95% CI: 2.62-2.84) for nonselective NSAIDs and 2.17 (95% CI: 1.83-2.57) for celecoxib. The OR reached 3.05 for the use of acetic acid derivatives. Compared with the oral forms, significantly higher risks were seen in parenteral NSAID use (OR: 8.66, 95% CI: 6.12-20.19). NSAIDs should be prescribed with caution, especially for those in ESRD high-risk groups.

  11. Preference, satisfaction and critical errors with Genuair and Breezhaler inhalers in patients with COPD: a randomised, cross-over, multicentre study

    PubMed Central

    Pascual, Sergi; Feimer, Jan; De Soyza, Anthony; Sauleda Roig, Jaume; Haughney, John; Padullés, Laura; Seoane, Beatriz; Rekeda, Ludmyla; Ribera, Anna; Chrystyn, Henry

    2015-01-01

    Background: The specific attributes of inhaler devices can influence patient use, satisfaction and treatment compliance, and may ultimately impact on clinical outcomes in patients with chronic obstructive pulmonary disease (COPD). Aims: To assess patient preference, satisfaction and critical inhaler technique errors with Genuair (a multidose inhaler) and Breezhaler (a single-dose inhaler) after 2 weeks of daily use. Methods: Patients with COPD and moderate to severe airflow obstruction were randomised in a cross-over, open-label, multicentre study to consecutive once-daily inhalations of placebo via Genuair and Breezhaler, in addition to current COPD medication. The primary end point was the proportion of patients who preferred Genuair versus Breezhaler after 2 weeks (Patient Satisfaction and Preference Questionnaire). Other end points included overall satisfaction and correct use of the inhalers after 2 weeks, and willingness to continue with each device. Results: Of the 128 patients enrolled, 127 were included in the safety population (male n=91; mean age 67.6 years). Of the 110 of the 123 patients in the intent-to-treat population who indicated an inhaler preference, statistically significantly more patients preferred Genuair than Breezhaler (72.7 vs. 27.3%; P<0.001). Mean overall satisfaction scores were also greater for Genuair than for Breezhaler (5.9 vs. 5.3, respectively; P<0.001). After 2 weeks, there was no statistically significant difference in the number of patients who made ⩾1 critical inhaler technique error with Breezhaler than with Genuair (7.3 vs. 3.3%, respectively). Conclusions: Patient overall preference and satisfaction was significantly higher with Genuair compared with Breezhaler. The proportion of patients making critical inhaler technique errors was low with Genuair and Breezhaler. PMID:25927321

  12. Sign Crossover in All Maxwell-Stefan Diffusivities for Molten Salt LiF-BeF2: A Molecular Dynamics Study.

    PubMed

    Chakraborty, Brahmananda

    2015-08-20

    Applying Green-Kubo formalism and equilibrium molecular dynamics (MD) simulations, we have studied for the first time the dynamic correlation, Onsager coefficients, and Maxwell-Stefan (MS) diffusivities of molten salt LiF-BeF2, which is a potential candidate for a coolant in a high temperature reactor. We observe an unusual composition dependence and strikingly a crossover in sign for all the MS diffusivities at a composition of around 7% of LiF where the MS diffusivity between cation-anion pair (Đ(BeF) and Đ(LiF)) jumps from positive to negative value while the MS diffusivity between cation-cation pair (Đ(LiBe)) becomes positive from a negative value. Even though the negative MS diffusivities have been observed for electrolyte solutions between cation-cation pair, here we report negative MS diffusivity between cation-anion pair where Đ(BeF) shows a sharp rise around 66% of BeF2, reaches maximum value at 70% of BeF2, and then decreases almost exponentially with a sign change for BeF2 around 93%. For low mole fraction of LiF, Đ(BeF) follows the Debye-Huckel theory and rises with the square root of LiF mole fraction similar to the MS diffusivity between cation-anion pair in aqueous solution of electrolyte salt. Negative MS diffusivities while unusual are, however, shown to satisfy the non-negative entropy constraints at all thermodynamic states as required by the second law of thermodynamics. We have established a strong correlation between the structure and dynamics and predict that the formation of flouride polyanion network between Be and F ions and coulomb interaction is responsible for sharp variation of the MS diffusivities which controls the multicomponent diffusion phenomenon in LiF-BeF2 which has a strong impact on the performance of the reactor.

  13. No Evidence of Dehydration with Moderate Daily Coffee Intake: A Counterbalanced Cross-Over Study in a Free-Living Population

    PubMed Central

    Killer, Sophie C.; Blannin, Andrew K.; Jeukendrup, Asker E.

    2014-01-01

    It is often suggested that coffee causes dehydration and its consumption should be avoided or significantly reduced to maintain fluid balance. The aim of this study was to directly compare the effects of coffee consumption against water ingestion across a range of validated hydration assessment techniques. In a counterbalanced cross-over design, 50 male coffee drinkers (habitually consuming 3–6 cups per day) participated in two trials, each lasting three consecutive days. In addition to controlled physical activity, food and fluid intake, participants consumed either 4×200 mL of coffee containing 4 mg/kg caffeine (C) or water (W). Total body water (TBW) was calculated pre- and post-trial via ingestion of Deuterium Oxide. Urinary and haematological hydration markers were recorded daily in addition to nude body mass measurement (BM). Plasma was analysed for caffeine to confirm compliance. There were no significant changes in TBW from beginning to end of either trial and no differences between trials (51.5±1.4 vs. 51.4±1.3 kg, for C and W, respectively). No differences were observed between trials across any haematological markers or in 24 h urine volume (2409±660 vs. 2428±669 mL, for C and W, respectively), USG, osmolality or creatinine. Mean urinary Na+ excretion was higher in C than W (p = 0.02). No significant differences in BM were found between conditions, although a small progressive daily fall was observed within both trials (0.4±0.5 kg; p<0.05). Our data show that there were no significant differences across a wide range of haematological and urinary markers of hydration status between trials. These data suggest that coffee, when consumed in moderation by caffeine habituated males provides similar hydrating qualities to water. PMID:24416202

  14. Oral nitric-oxide donor glyceryl-trinitrate induces sensitization in spinal cord pain processing in migraineurs: a double-blind, placebo-controlled, cross-over study.

    PubMed

    Perrotta, Armando; Serrao, Mariano; Tassorelli, Cristina; Arce-Leal, Natalia; Guaschino, Elena; Sances, Grazia; Rossi, Paolo; Bartolo, Michelangelo; Pierelli, Francesco; Sandrini, Giorgio; Nappi, Giuseppe

    2011-05-01

    Nitric-oxide donor glyceryl-trinitrate (GTN) modulates cerebral and spinal regions that are involved in migraine and pain processing. We hypothesized that in migraineurs, the susceptibility to develop a migraine attack after GTN administration should parallel with an high sensitivity to GTN-induced change in the pain processing at spinal level. We used the temporal summation threshold (TST) of the lower limb nociceptive withdrawal reflex (NWR) and the related pain sensation to study in parallel the time-course of the effect of the GTN administration on the pain processing at spinal level in migraine and healthy subjects. Twenty-eight (21 F; 7M; mean age 34.2 ± 8.2) migraine and 15 (11 F; 4M; mean age 35.9 ± 8.9) healthy subjects were recruited in a double-blind, placebo-controlled, cross-over trial. Neurophysiological examinations were carried out before (baseline) and 30', 60', 120', 180' and 240' after GTN (0.9 mg sublingual) or placebo administration during two different sessions. In migraineurs, GTN administration was associated to a significant facilitation in temporal summation of pain (reduced TST and increased painful sensation) 60', 120' and 180' after drug intake when compared to baseline, to placebo condition and to controls after GTN intake. Furthermore, in migraineurs who developed migraine after GTN, a significant facilitation in temporal summation of pain was detected 60', 120' and 180' after drug intake when compared to patients without clinical response. In migraineurs the susceptibility to develop migraine attack after GTN administration seems to be a specific trait of a subgroup of patients linked to a supersensitivity of the pain system to GTN.

  15. A randomized crossover study comparing trehalose/hyaluronate eyedrops and standard treatment: patient satisfaction in the treatment of dry eye syndrome

    PubMed Central

    Pinto-Bonilla, Juan Carlos; del Olmo-Jimeno, Alberto; Llovet-Osuna, Fernando; Hernández-Galilea, Emiliano

    2015-01-01

    Dry eye is a common disorder in routine ophthalmological practice, and a better understanding of the complex pathophysiology is leading to improved treatment. Thealoz Duo® is a novel artificial tear preparation containing two active ingredients: Trehalose, a naturally occurring disaccharide with anhydrobiotic functions in many organisms, and hyaluronate, a widely distributed anionic glycosaminoglycan polysaccharide with lubricative and water-retaining properties in biological systems. In a randomized, single center, open label, crossover study, 17 adult patients with moderate-to-severe dry eye syndrome were randomized to treatment with Thealoz Duo® (combining trehalose and hyaluronic acid) or Systane®. Patients received 7 days of treatment. The primary efficacy variable was patient satisfaction evaluated by a 0–100 visual analog scale evaluated on days 0 and 7 of treatment. Secondary parameters included ocular surface disease index (OSDI), symptoms of dry eye, ocular staining scores (fluorescein and lissamine green), ocular clinical signs, Schirmer test, tear breakup time, and global efficacy assessed by the patient and the investigator. Seventeen patients were included. Patient satisfaction improved from 44.5±19.0 to 70.2±19.2 mm during Thealoz Duo® treatment and from 47.2±23 to 57.1±19.1 mm during Systane® treatment (P=0.043, mixed-effects analysis of covariance). Two secondary efficacy parameters (dry eye symptoms and the impact of their symptoms on work) showed statistically significant advantages for Thealoz Duo® over Systane®. There were no statistically significant advantages for Systane® over Thealoz Duo® for any measured parameter. No adverse events were reported. Thealoz Duo® appears to be an effective combination of two active ingredients for the treatment of dry eye and is at least as effective as Systane®. PMID:25926736

  16. Effects of Arabinoxylan and Resistant Starch on Intestinal Microbiota and Short-Chain Fatty Acids in Subjects with Metabolic Syndrome: A Randomised Crossover Study

    PubMed Central

    Moore, Mary E.; Dige, Anders; Lærke, Helle Nygaard; Agnholt, Jørgen; Bach Knudsen, Knud Erik; Hermansen, Kjeld; Marco, Maria L.; Gregersen, Søren; Dahlerup, Jens F.

    2016-01-01

    Recently, the intestinal microbiota has been emphasised as an important contributor to the development of metabolic syndrome. Dietary fibre may exert beneficial effects through modulation of the intestinal microbiota and metabolic end products. We investigated the effects of a diet enriched with two different dietary fibres, arabinoxylan and resistant starch type 2, on the gut microbiome and faecal short-chain fatty acids. Nineteen adults with metabolic syndrome completed this randomised crossover study with two 4-week interventions of a diet enriched with arabinoxylan and resistant starch and a low-fibre Western-style diet. Faecal samples were collected before and at the end of the interventions for fermentative end-product analysis and 16S ribosomal RNA bacterial gene amplification for identification of bacterial taxa. Faecal carbohydrate residues were used to verify compliance. The diet enriched with arabinoxylan and resistant starch resulted in significant reductions in the total species diversity of the faecal-associated intestinal microbiota but also increased the heterogeneity of bacterial communities both between and within subjects. The proportion of Bifidobacterium was increased by arabinoxylan and resistant starch consumption (P<0.001), whereas the proportions of certain bacterial genera associated with dysbiotic intestinal communities were reduced. Furthermore, the total short-chain fatty acids (P<0.01), acetate (P<0.01) and butyrate concentrations (P<0.01) were higher by the end of the diet enriched with arabinoxylan and resistant starch compared with those resulting from the Western-style diet. The concentrations of isobutyrate (P = 0.05) and isovalerate (P = 0.03) decreased in response to the arabinoxylan and resistant starch enriched diet, indicating reduced protein fermentation. In conclusion, arabinoxylan and resistant starch intake changes the microbiome and short-chain fatty acid compositions, with potential beneficial effects on colonic health

  17. Ab initio study of the influence of structural parameters on the potential energy surfaces of spin-crossover Fe(II) model compounds

    NASA Astrophysics Data System (ADS)

    Boilleau, Corentin; Suaud, Nicolas; Guihéry, Nathalie

    2012-12-01

    In spin-crossover (SCO) compounds exhibiting a light induced excited spin state trapping (LIESST) effect, the thermodynamic T1/2 and kinetic T(LIESST) temperature values depend on the features of the potential energy surfaces (PES) of the two lowest singlet and quintet states but also on vibrational contributions, collective effects, such as electrostatics, for instance, spin-orbit couplings to a lesser extent, etc. In this work, the question of the link between the shape of the PES of SCO compounds exhibiting a LIESST effect and their first coordination sphere structure is addressed from wave function theory based ab initio calculations. Fe(II) complexes based on model ligands suited to reproduce the main characteristics of the PES of such compounds are distorted to emphasize selectively the role played by the metal-ligand distances and the ligand-metal-ligand angles. The studied angular deformations are those usually observed in many Fe(L)2(NCS)2 complexes. It is shown that the larger the deformation between the low spin and high spin equilibrium geometries, the higher the energy barrier from the high spin state and the weaker the energy difference between the bottom of the wells. These results corroborate observations made by experimentalists on a large number of complexes. While the PES features only constitutes one of the contributions to these temperatures, it is worth noticing that, relating T1/2 to the energy difference between the bottoms of the singlet and quintet wells and the T(LIESST) to the energy barrier from the quintet bottom well, the same slope of the empirical law T(LIESST) = -0.3T1/2+T0 is observed.

  18. Truview EVO2 and standard Macintosh laryngoscope for tracheal intubation during cardiopulmonary resuscitation: a comparative randomized crossover study.

    PubMed

    Gaszynska, Ewelina; Gaszynski, Tomasz

    2014-09-01

    The aim of this study was to compare the performance of the Truview EVO2 laryngoscope in manikin-simulated cardiopulmonary resuscitation (CPR) and no-CPR scenarios with standard intubation technique. Participants performed 4 scenarios in random order: endotracheal intubation (ETI) using Macintosh laryngoscope (MCL), Truview EVO2 laryngoscope in no-CPR patient scenario, and intubation during uninterrupted chest compressions using both laryngoscopes. The participants were directed to make 3 attempts in each scenario. Primary outcomes were time to tracheal intubation (TTI) and intubation success, whereas secondary outcomes were cumulative success ratio and the number of esophageal intubation (EI). TTI and success ratios were reported per attempt. Thirty paramedics completed the study. Median TTI with Truview EVO2 with CPR was 36 (interquartile range [IQR] 29.00-52.00), 22.5 (IQR 18.33-35.00), and 18 (IQR 11.00-23.00) seconds; MCL with CPR was 23 (IQR 18.92-36.90), 16.8 (IQR 14.00-22.31), and 14.5 (IQR 11.12-16.36) seconds; Truview EVO2 without CPR was 28.6 (IQR 24.02-38.34), 21.7 (IQR 17.00-25.00), and 13 (IQR 11.90-17.79) seconds; MCL without CPR was 17 (IQR 13.23-22.29), 13 (IQR 12.09-15.26), and 12.4 (IQR 10.08-19.84) seconds for first, second, and third attempts, respectively. The P values for differences in TTI between Truview EVO2 and MCL were P < 0.0001, P = 0.0540, and P = 0.7550 in CPR scenario and P = 0.0080, P = 0.1570, and P = 0.7652 in no-CPR scenario for first, second, and third attempts, respectively. The success ratios for each of the scenarios were as follows: in CPR scenario it was 0.73 versus 0.53 (P = 0.0558), 0.83 versus 0.76 (P = 0.2633), and 1 versus 0.8 (P = 0.0058); in no-CPR scenario it was 0.63 versus 0.73 (P = 0.2068), 0.86 versus 0.86, and 0.97 versus 1 (P = 0.1637) for Truview EVO2 vs MCL in first, second, and third attempts, respectively. The cumulative success ratio related to the time of ETI

  19. Pegylated filgrastim is comparable with filgrastim as support for commonly used chemotherapy regimens: a multicenter, randomized, crossover phase 3 study.

    PubMed

    Shi, Yuan-Kai; Chen, Qiang; Zhu, Yun-Zhong; He, Xiao-Hui; Wang, Hua-Qing; Jiang, Ze-Fei; Chang, Jian Hua; Liu, Yun-Peng; Wang, An-Lan; Luo, De-Yun; Zhang, Yang; Ke, Xiao-Yan; Li, Wei-Lian; Zhang, Wei-Jing; Wang, Xiu-Wen; Zhang, Yi-Ping; Wang, Jian-Min; Liu, Xiao-Qing

    2013-07-01

    The purpose of this study was to compare the efficacy and safety of a single subcutaneous injection of pegylated filgrastim with daily filgrastim as a prophylaxis for neutropenia induced by commonly used chemotherapy regimens. Fifteen centers enrolled 337 chemotherapy-naive cancer patients with normal bone marrow function. All patients randomized into AOB and BOA arms received two cycles of chemotherapy. Patients received a single dose of pegylated filgrastim 100 µg/kg in cycle 1 (AOB) or cycle 2 (BOA) and daily doses of filgrastim 5 µg/kg/day in cycle 1 (BOA) or cycle 2 (AOB). Efficacy and safety parameters were recorded. The primary end point was the rate of protection against grade 4 neutropenia after chemotherapy [defined as the rate at which the absolute neutrophil count (ANC) remained >0.5×10(9)/l throughout the entire cycle]. Ninety-four percent of patients receiving pegylated filgrastim or filgrastim did not develop grade 4 neutropenia. The incidence of ANC<1.0×10(9)/l was 16.0% (50/313) after support with either pegylated filgrastim or filgrastim. The incidences of febrile neutropenia and antibiotic administration were similar in both groups. Notably, faster ANC recovery was observed with pegylated filgrastim support. The ANC nadir was also earlier with pegylated filgrastim (day 7) support than with filgrastim support (day 9), although the depth of nadir was not significantly different. A single subcutaneous injection of pegylated filgrastim 100 μg/kg provided adequate and safe neutrophil support comparable with daily subcutaneous injections of unmodified filgrastim 5 μg/kg/day in patients receiving commonly used standard-dose mild-to-moderate myelosuppressive chemotherapy regimens.

  20. The Effects of Different Warm-up Volumes on the 100-m Swimming Performance: A Randomized Crossover Study.

    PubMed

    Neiva, Henrique P; Marques, Mário C; Barbosa, Tiago M; Izquierdo, Mikel; Viana, João L; Teixeira, Ana M; Marinho, Daniel A

    2015-11-01

    The aim of this study was to compare the effect of 3 different warm-up (WU) volumes on 100-m swimming performance. Eleven male swimmers at the national level completed 3 time trials of 100-m freestyle on separate days and after a standard WU, a short WU (SWU), or a long WU (LWU) in a randomized sequence. All of them replicated some usual sets and drills, and the WU totaled 1,200 m, the SWU totaled 600 m, and the LWU totaled 1,800 m. The swimmers were faster after the WU (59.29 seconds; confidence interval [CI] 95%, 57.98-60.61) and after the SWU (59.38 seconds; CI 95%, 57.92-60.84) compared with the LWU (60.18 seconds; CI 95%, 58.53-61.83). The second 50-m lap after the WU was performed with a higher stroke length (effect size [ES] = 0.77), stroke index (ES = 1.26), and propelling efficiency (ES = 0.78) than that after the SWU. Both WU and SWU resulted in higher pretrial values of blood lactate concentrations [La] compared with LWU (ES = 1.58 and 0.74, respectively), and the testosterone:cortisol levels were increased in WU compared with LWU (ES = 0.86). In addition, the trial after WU caused higher [La] (ES ≥ 0.68) and testosterone:cortisol values compared with the LWU (ES = 0.93). These results suggest that an LWU could impair 100-m freestyle performance. The swimmers showed higher efficiency during the race after a 1200-m WU, suggesting a favorable situation. It highlighted the importance of the [La] and hormonal responses to each particular WU, possibly influencing performance and biomechanical responses during a 100-m race. PMID:26506059

  1. Dynamical Landau theory of the glass crossover

    NASA Astrophysics Data System (ADS)

    Rizzo, Tommaso

    2016-07-01

    I introduce a dynamical field theory to describe the glassy behavior in supercooled liquids. The mean-field approximation of the theory predicts a dynamical arrest transition, as in the ideal mode-coupling theory and mean-field discontinuous spin-glass models. Instead, beyond the mean-field approximation, the theory predicts that the transition is avoided and transformed into a crossover, as observed in experiments and simulations. To go beyond mean-field, a standard perturbative loop expansion is performed at first. Approaching the ideal critical point this expansion is divergent at all orders and I show that the leading divergent term at any given order is the same as a dynamical stochastic equation, called stochastic-beta relaxation (SBR) in Europhys. Lett. 106, 56003 (2014), 10.1209/0295-5075/106/56003. At variance with the original theory, SBR can be studied beyond mean-field directly, without the need to resort to a perturbative expansion. Thus it provides a qualitative and quantitative description of the dynamical crossover. For consistency reasons, it is important to establish the connection between the dynamical field theory and SBR beyond perturbation theory. This can be done with the help of a stronger result: the dynamical field theory is exactly equivalent to a theory with quenched disorder. Qualitatively, the nonperturbative mechanism leading to the crossover is therefore the same as the mechanism of SBR. Quantitatively, SBR is equivalent to making the mean-field approximation once the quenched disorder has been generated.

  2. Thermogenic effect of meltdown RTD™ energy drink in young healthy women: a double blind, cross-over design study

    PubMed Central

    2009-01-01

    Background The purpose of this study was to examine the acute metabolic effects of a high-energy drink in healthy, physically-active women. Methods Ten women (20.4 ± 0.70 y; 166.9 ± 7.2 cm; 67.0 ± 7.0 kg; 29.6 ± 6.5% body fat) underwent two testing sessions administered in a randomized and double-blind fashion. Subjects reported to the laboratory in a 3-hr post-absorptive state and were provided either 140 ml of the high-energy drink (SUP; commercially marketed as Meltdown RTD™) or placebo (P). Subjects consumed two 70 ml doses of SUP or P, separated by 30 min and rested in a semi-recumbent position for 3 hours. Resting oxygen consumption (VO2) and heart rate (HR) were determined every 5 min during the first 30 min and every 10 min during the next 150 min. Blood pressure (BP) was determined every 15 min during the first 30 min and every 30 min thereafter. Area under the curve (AUC) analysis was computed for VO2, whereas a 3-hour average and hourly averages were calculated for respiratory quotient (RQ), total kcal, HR, BP, and profile of mood states (POMS). Results AUC analysis revealed a 10.8% difference (p = 0.03) in VO2 between SUP and P. No difference in VO2 was seen between the groups in the first hour, but VO2 in SUP was significantly greater than P in the second (13.9%, p = 0.01) and third hours (11.9%, p = 0.03). A difference (p = 0.03) in energy expenditure was seen between SUP (1.09 ± 0.10 kcal·min-1) and P (0.99 ± 0.09 kcal·min-1) for the 3-hour period. Although no difference in energy expenditure was seen in the first hour, significant differences between SUP and P were observed in the second (1.10 ± 0.11 kcal·min-1 and 0.99 ± 0.09 kcal·min-1, respectively; p = 0.02) and third hour (1.08 ± 0.11 kcal·min-1 and 0.99 ± 0.09 kcal·min-1, respectively; p = 0.05). Average systolic BP was significantly higher (p = 0.007) for SUP (110.0 ± 3.9 mmHg) compared to P (107.3 ± 4.4 mmHg). No differences were seen in HR, diastolic BP, or POMS at any

  3. 3-Way characterization of soils by Procrustes rotation, matrix-augmented principal components analysis and parallel factor analysis.

    PubMed

    Andrade, J M; Kubista, M; Carlosena, A; Prada, D

    2007-11-01

    Three different approaches for 3-way analyses, namely, Procrustes rotation, parallel factor analysis (PARAFAC) and matrix-augmented principal component analysis, have been compared considering a four-seasons study on soil pollution. Each sampling season comprised 92 roadsoil samples and 12 analytical variables (heavy metals, loss on ignition, pH and humidity). Results show that the three chemometric techniques lead to essentially the same conclusions. Hence, Procrustes rotation, a mathematical technique scarcely applied in analytical chemistry, revealed as a useful tool for 3-way data analysis with potential advantages, including its conceptual simplicity and straightforward interpretation of the results. A novel application of the consensus vectors allowed definition of "consensus scores" so that visualization of the samples and temporal patterns can be made. Results also suggested that the trilinearity assumption imbedded in PARAFAC is essentially fulfilled when studying the temporal evolution of an environmental system where no new pollution sources appear during the course of the study. PMID:17950053

  4. Bioequivalence of acenocoumarol in chilean volunteers: an open, randomized, double-blind, single-dose, 2-period, and 2-sequence crossover study for 2 oral formulations.

    PubMed

    Sasso, J; Carmona, P; Quiñones, L; Ortiz, M; Tamayo, E; Varela, N; Cáceres, D; Saavedra, I

    2012-08-01

    The aim of this study was to compare the bioavailability of an oral formulation of the coumarin derivative-vitamine K antagonist acenocoumarol (Acebron™ 4 mg, Test) with the reference formulation (Neo-Sintrom™ 4 mg). We performed a single-dose, double-blind, fasting, 2-period, 2-sequence, crossover study design. Plasma concentrations of acenocoumarol were determined using a validated UPLC-MS/MS method. 24 healthy Chilean volunteers (11 male, 13 female) were enrolled and all of them completed the study. Adverse events were monitored throughout the study. The values of the pharmacokinetic parameters were (mean ± SD): AUC0-24 =1 364.38±499.26 ngxh/mL for the test and 1 328.39±429.20 ngxh/mL for the reference; AUC0-∞ =1 786.00±732.85 ngxh/mL for the test and 1 706.71±599.66 ngxh/mL for the reference; Cmax =180.69±35.11 ng/mL with a Tmax of 1.83±0.95 h for the test and 186.97±38.21 ng/mL with a Tmax of 2.19±0.83 h for the reference. Regarding half life measurements, the mean ± SD of t1/2 were 11.84±4.54 h for the test and 11.08±3.28 h for the reference. The 90% confidence intervals for the test/reference ratio using logarithmic transformed data were 97.89-100.87%, 98.62-101.99% and 98.64-102.38% for Cmax, AUC0-t(24) and AUC0-∞. There were no significant differences in pharmacokinetic parameters between groups.The results obtained in this study lead us to conclude, based on FDA criteria, that the test acenocoumarol formulation (Acebron™, 4 mg tablets) is bioequivalent to the reference product (Neo-Sintrom™, 4 mg tablets). PMID:22773430

  5. Consistency of response to sumatriptan/naproxen sodium in a randomized placebo-controlled, cross-over study for the acute treatment of migraine in adolescence.

    PubMed

    Winner, Paul; Linder, Steven; Hershey, Andrew D

    2015-04-01

    A multi-centered, randomized, placebo-controlled, early intervention, cross-over study was conducted to evaluate the consistency of response of sumatriptan/naproxen sodium 85/500 mg (S/NS) over 4 attacks in the acute treatment of migraine in adolescents. Inclusion of subjects was dependent on their age of 12-17 years, frequency, and history of migraine headaches (1-8 per month) over the previous 6 months prior to screening and generally healthy males and females of non-childbearing potential that were not on excluded medications. Subjects were instructed to treat within 1 hour of pain onset, including when the pain was still mild. Subjects were randomized in a double-blind fashion using a computer-generated randomization list in which the study drug was prepared prior to study start, and subjects were allocated to a number in sequential order for each site. Each site was allocated number blocks in sets of 10 depending of the rate of enrollment. The objective of this study was to examine the efficacy of S/NS vs placebo in the primary end-points of pain-free response at 2 hours (2hPF), 24-hour sustained pain-free response (24hPF), and pain-free response at 2 hours with early intervention (2hPFE) calculated as percentage out of all attacks. In the study, 94 subjects treated 347 attacks in total: treating 277 with S/NS and 70 with placebo. Compared with placebo, S/NS produced higher 2hPF rates (S/NS 37%, placebo 18%; P < .004), and 2hPFE with rates (S/NS 32%, 18% placebo; P < .03). Compared with placebo, 24hPF rates were S/NS 86%, placebo 78%, P < .17, which were higher than placebo but not clinically significant. 2hPF was reported in at least 2 of the 3 migraines treated with S/NS in 40.4% of subjects. 24hPF was reported in at least 2 of the 3 migraine treated with S/NS in 86.2% subjects. Adverse reactions were generally low and comparable between S/NS and placebo.

  6. Search for atoxic cereals: a single blind, cross-over study on the safety of a single dose of Triticum monococcum, in patients with celiac disease

    PubMed Central

    2013-01-01

    Background Cereals of baking quality with absent or reduced toxicity are actively sought as alternative therapy to a gluten-free diet (GFD) for patients with coeliac disease (CD). Triticum monococcum, an ancient wheat, is a potential candidate having no toxicity in in-vitro and ex-vivo studies. The aim of our study was to investigate on the safety of administration of a single dose of gluten of Tm in patients with CD on GFD. Methods We performed a single blind, cross-over study involving 12 CD patients who had been on a GFD for at least 12 months, challenged on day 0, 14 and 28 with a single fixed dose of 2.5 grams of the following (random order): Tm, rice (as reference atoxic protein) and Amygluten (as reference toxic protein) dispersed in a gluten-free pudding. The primary end-point of the study was the change in intestinal permeability, as assessed by changes in the urinary lactulose/rhamnose ratio (L/R ratio) measured by High Pressure Liquid Chromatography. We also assessed the occurrence of adverse gastrointestinal events, graded for intensity and duration according to the WHO scale. Variables were expressed as mean ± SD; paired t-test and χ2 test were used as appropriate. Results The urinary L/R ratio did not change significantly upon challenge with the 3 cereals, and was 0.055 ± 0.026 for Tm Vs 0.058 ± 0.035 for rice (p = 0.6736) and Vs 0.063 ± 0.054 with Amygluten (p = 0.6071). Adverse gastrointestinal events were 8 for Tm, Vs 11 for rice (p = 0.6321) and Vs 31 for Amygluten p = 0.0016), and, in all cases events were graded as “mild” or “moderate” with TM and rice, and as “severe” or “disabling” in 4 cases during Amygluten. Conclusions No definite conclusion can be drawn on the safety of Tm, based on no change in urinary L/R because even Amygluten, a toxic wheat protein, did not cause a significant change in urinary L/R indicating low sensitivity of this methodology in studies on acute toxicity. Tm was

  7. Hydrogen sulfide and traffic-related air pollutants in association with increased mortality: a case-crossover study in Reykjavik, Iceland

    PubMed Central

    Finnbjornsdottir, Ragnhildur Gudrun; Elvarsson, Bjarki Thor; Gislason, Thorarinn; Rafnsson, Vilhjalmur

    2015-01-01

    Objectives To study the association between daily mortality and short-term increases in air pollutants, both traffic-related and the geothermal source-specific hydrogen sulfide (H2S). Design Population-based, time stratified case-crossover. A lag time to 4 days was considered. Seasonal, gender and age stratification were calculated. Also, the best-fit lag when introducing H2S >7 µg/m3 was selected by the Akaike Information Criterion (AIC). Setting The population of the greater Reykjavik area (n=181 558) during 2003–2009. Participants Cases were defined as individuals living in the Reykjavik capital area, 18 years or older (N=138 657), who died due to all natural causes (ICD-10 codes A00-R99) other than injury, poisoning and certain other consequences of external causes, or cardiovascular disease (ICD-10 codes I00-I99) during the study period. Main outcome measure Percentage increases in risk of death (IR%) following an interquartile range increase in pollutants. Results The total number of deaths due to all natural causes was 7679 and due to cardiovascular diseases was 3033. The interquartile range increased concentrations of H2S (2.6 µg/m3) were associated with daily all natural cause mortality in the Reykjavik capital area. The IR% was statistically significant during the summer season (lag 1: IR%=5.05, 95% CI 0.61 to 9.68; lag 2: IR%=5.09, 95% CI 0.44 to 9.97), among males (lag 0: IR%=2.26, 95% CI 0.23 to 4.44), and among the elderly (lag 0: IR%=1.94, 95% CI 0.12 to 1.04; lag 1: IR%=1.99, 95% CI 0.21 to 1.04), when adjusted for traffic-related pollutants and meteorological variables. The traffic-related pollutants were generally not associated with statistical significant IR%s. Conclusions The results suggest that ambient H2S air pollution may increase mortality in Reykjavik, Iceland. To the best of our knowledge, ambient H2S exposure has not previously been associated with increased mortality in population-based studies and therefore the results

  8. A randomized crossover-design study to investigate the plaque removal efficacy of two power toothbrushes: Philips Sonicare Flexcare and Oral-B Triumph.

    PubMed

    Putt, Mark S; Milleman, Jeffery L; Jenkins, Wendy; Schmitt, Paul; Master, Aditi S; Strate, Joerg

    2008-01-01

    The Sonicare FlexCare and the Oral-B Triumph Professional Care 9000 power toothbrushes were compared in a single-use, examiner-masked, crossover clinical trial. Outcomes were evaluated using the Turesky Modified Quigley-Hein (TMQH) plaque index. Percent reduction in overall plaque score because of toothbrushing was the primary efficacy measure. Subjects were required to have a TMQH score > or = 1.8 at screening after refraining from oral hygiene for 24 hours. The study included three visits. At visit 1, subjects were randomized to one of two treatment sequences, given their first toothbrush and toothpaste, and instructed to use them twice daily for 2 minutes during a 1-week familiarization phase. Before visit 2, subjects again refrained from oral hygiene for 24 hours. At this visit, plaque scores were assessed before and after a 2-minute supervised brushing episode, then the second test product was issued. Familiarization, plaque accumulation, and clinical examinations were the same for both product use periods. Data were analyzed using a linear mixed effects model with subject as a grouping factor. Treatment effects were expressed as mean values and the appropriate 95% confidence intervals (CI). Ninety-six subjects were screened with 93 subjects completing the study. The sample's TMQH score at Visit 1 was 3.18 +/- 0.42 (mean +/- standard deviation [SD]). Full-mouth prebrushing plaque scores were 2.85 +/- 0.49 for FlexCare and 2.94 +/- 0.45 for Triumph. Respective full-mouth reductions in overall plaque score were 38.02% +/- 15.14% and 30.43% +/- 14.05%. The estimated treatment effect, expressed as difference between FlexCare and Triumph in percent plaque index reduction, was 7.59% with a 95% CI from 4.79% to 10.40%. Similar differences were observed for all subregions, including anterior, posterior, interproximal, and interproximal posterior sites. The same protocol design was used at an earlier study in another center. The combined overall treatment effect from

  9. A randomized crossover-design study to investigate the plaque removal efficacy of two power toothbrushes: Philips Sonicare Flexcare and Oral-B Triumph.

    PubMed

    Putt, Mark S; Milleman, Jeffery L; Jenkins, Wendy; Schmitt, Paul; Master, Aditi S; Strate, Joerg

    2008-01-01

    The Sonicare FlexCare and the Oral-B Triumph Professional Care 9000 power toothbrushes were compared in a single-use, examiner-masked, crossover clinical trial. Outcomes were evaluated using the Turesky Modified Quigley-Hein (TMQH) plaque index. Percent reduction in overall plaque score because of toothbrushing was the primary efficacy measure. Subjects were required to have a TMQH score > or = 1.8 at screening after refraining from oral hygiene for 24 hours. The study included three visits. At visit 1, subjects were randomized to one of two treatment sequences, given their first toothbrush and toothpaste, and instructed to use them twice daily for 2 minutes during a 1-week familiarization phase. Before visit 2, subjects again refrained from oral hygiene for 24 hours. At this visit, plaque scores were assessed before and after a 2-minute supervised brushing episode, then the second test product was issued. Familiarization, plaque accumulation, and clinical examinations were the same for both product use periods. Data were analyzed using a linear mixed effects model with subject as a grouping factor. Treatment effects were expressed as mean values and the appropriate 95% confidence intervals (CI). Ninety-six subjects were screened with 93 subjects completing the study. The sample's TMQH score at Visit 1 was 3.18 +/- 0.42 (mean +/- standard deviation [SD]). Full-mouth prebrushing plaque scores were 2.85 +/- 0.49 for FlexCare and 2.94 +/- 0.45 for Triumph. Respective full-mouth reductions in overall plaque score were 38.02% +/- 15.14% and 30.43% +/- 14.05%. The estimated treatment effect, expressed as difference between FlexCare and Triumph in percent plaque index reduction, was 7.59% with a 95% CI from 4.79% to 10.40%. Similar differences were observed for all subregions, including anterior, posterior, interproximal, and interproximal posterior sites. The same protocol design was used at an earlier study in another center. The combined overall treatment effect from

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

    PubMed

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

    2016-09-01

    Medication adherence is crucial for success in the management of patients with chronic conditions. This study analyzes whether a mobile application on a tablet aimed at supporting drug intake and vital sign parameter documentation affects adherence in elderly patients.Patients with coronary heart disease and no prior knowledge of tablet computers were recruited. They received a personal introduction to the mobile application Medication Plan, installed on an Apple iPad. The study was conducted using a crossover design with 3 sequences: initial phase, interventional phase (28 days of using the app system), and comparative phase (28 days of using a paper diary). Users experienced the interventional and comparative phases alternately.A total of 24 patients (12 males; mean age 73.8 years) were enrolled in the study. The mean for subjectively assessed adherence (A14-scale; 5-point Likert scale, from "never" to "very often" which results in a score from 0 to 56) before the study was 50.0 (SD = 3.44). After both interventions there was a significant increase, which was more pronounced after the interventional phase (54.0; SD = 2.01) than after the comparative phase (52.6; SD = 2.49) (for all pairs after both interventions, P <0.001). Neither medical conditions nor the number of drug intake (amount and frequency of drug taking) per day affected subjective adherence. Logging data showed a significantly stronger adherence for the medication app than the paper system for both blood pressure recordings (P <0.001) and medication intake (P = 0.033). The majority of participants (n = 22) stated that they would like to use the medication app in their daily lives and would not need further assistance with the app.A mobile app for medication adherence increased objectively and subjectively measured adherence in elderly users undergoing rehabilitation. The findings have promising clinical implications: digital tools can assist chronic disease patients achieve adherence to

  11. Effects of Pitavastatin on Lipid Profiles in HIV-Infected Patients with Dyslipidemia and Receiving Atazanavir/Ritonavir: A Randomized, Double-Blind, Crossover Study

    PubMed Central

    Wongprikorn, Asita; Sukasem, Chonlaphat; Puangpetch, Apichaya; Numthavej, Pawin; Thakkinstian, Ammarin; Kiertiburanakul, Sasisopin

    2016-01-01

    Background Dyslipidemia as a risk factor of cardiovascular disease is common especially in HIV-infected patients who are using protease inhibitors (PIs) including atazanavir. Pitavastatin has less drug-drug interactions and demonstrable efficacy in decreasing lipid levels in non HIV-infected individuals. Materials and Methods This study was a randomized, double-blind, crossover study comparing the safety and efficacy of pitavastatin vs placebo in HIV-infected patients with dyslipidemia and receiving atazanavir/ritonavir (ATV/r). Patients were randomized to receive either placebo or pitavastatin for 12 weeks. The follow-up visits were every 4 weeks until the end of the study. Results A total of 12 HIV-infected patients were enrolled to each study group. Of all, 14 (58%) patients were men and mean (standard deviation, SD) age was 48.1 (1.8) years. At 12 weeks of treatment with pitavastatin compared to placebo; mean [95% confidence interval (CI)] total cholesterol (TC) was 207 (187.3, 226.8) mg/dL vs 246.3 (226.5, 266) mg/dL (p <0.001); mean (95% CI) triglyceride (TG) was 351.3 (193.2, 509.4) mg/dL vs 279.1 (121, 437.2) mg/dL (p = 0.269); mean (95% CI) high density lipoprotein (HDL) was 45.3 (40.4, 50.2) mg/dL vs 44.2 (39.3, 49.1) mg/dL (p = 0.354); and mean (95% CI) low density lipoprotein (LDL) was 113.2 (100.4, 126) mg/dL vs 145.6 (132.8, 158.4) mg/dL (p <0.001). Mean liver enzyme and median creatine phosphokinase levels were not statistically significant between patients receiving placebo and pitavastatin. Conclusions Pitavastatin decreases TC and LDL level at 12 weeks significantly and shows indifferent in hepatotoxicity and creatine phosphokinase levels compared to those of placebo. Thus, pitavastatin can be a good option of lipid-lowering agent in HIV-infected patients who are receiving ATV/r. Trial Registration ClinicalTrials.gov NCT02442700 PMID:27304841

  12. The effect of oxygen crossover on the anode of a Li-O(2) battery using an ether-based solvent: insights from experimental and computational studies.

    PubMed

    Assary, Rajeev S; Lu, Jun; Du, Peng; Luo, Xiangyi; Zhang, Xiaoyi; Ren, Yang; Curtiss, Larry A; Amine, Khalil

    2013-01-01

    Crosstown traffic: Further development of Li-O(2) batteries may eventually lead to their use in transportation applications. One problem that needs to be addressed is electrolyte decomposition, which has been partially mitigated by using ether- rather than carbonate-based solvents. The influence of oxygen crossover from the cathode to the anode on electrolyte, and lithium anode, decomposition in ether-based Li-O(2) batteries is investigated.

  13. The effect of oxygen crossover on the anode of a Li-O(2) battery using an ether-based solvent: insights from experimental and computational studies.

    PubMed

    Assary, Rajeev S; Lu, Jun; Du, Peng; Luo, Xiangyi; Zhang, Xiaoyi; Ren, Yang; Curtiss, Larry A; Amine, Khalil

    2013-01-01

    Crosstown traffic: Further development of Li-O(2) batteries may eventually lead to their use in transportation applications. One problem that needs to be addressed is electrolyte decomposition, which has been partially mitigated by using ether- rather than carbonate-based solvents. The influence of oxygen crossover from the cathode to the anode on electrolyte, and lithium anode, decomposition in ether-based Li-O(2) batteries is investigated. PMID:23208891

  14. Efficacy of a Mandibular Advancement Appliance on Sleep Disordered Breathing in Children: A Study Protocol of a Crossover Randomized Controlled Trial

    PubMed Central

    Idris, Ghassan; Galland, Barbara; Robertson, Christopher J.; Farella, Mauro

    2016-01-01

    Background: Sleep-Disordered Breathing (SDB) varies from habitual snoring to partial or complete obstruction of the upper airway and can be found in up to 10% of children. SDB can significantly affect children's wellbeing, as it can cause growth disorders, educational and behavioral problems, and even life-threatening conditions, such as cardiorespiratory failure. Adenotonsillectomy represents the primary treatment for pediatric SDB where adeno-tonsillar hypertrophy is indicated. For those with craniofacial anomalies, or for whom adenotonsillectomy or other treatment modalities have failed, or surgery is contra-indicated, mandibular advancement splints (MAS) may represent a viable treatment option. Whilst the efficacy of these appliances has been consistently demonstrated in adults, there is little information about their effectiveness in children. Aims: To determine the efficacy of mandibular advancement appliances for the management of SDB and related health problems in children. Methods/design: The study will be designed as a single-blind crossover randomized controlled trial with administration of both an “Active MAS” (Twin-block) and a “Sham MAS.” Eligible participants will be children aged 8–12 years whose parents report they snore ≥3 nights per week. Sixteen children will enter the full study after confirming other inclusion criteria, particularly Skeletal class I or class II confirmed by lateral cephalometric radiograph. Each child will be randomly assigned to either a treatment sequence starting with the Active or the Sham MAS. Participants will wear the appliances for 3 weeks separated by a 2-week washout period. For each participant, home-based polysomnographic data will be collected four times; once before and once after each treatment period. The Apnea Hypopnea Index (AHI) will represent the main outcome variable. Secondary outcomes will include, snoring frequency, masseter muscle activity, sleep symptoms, quality of life, daytime

  15. Pharmacokinetic and pharmacodynamic comparison of two "pegylated" interferon alpha-2 formulations in healthy male volunteers: a randomized, crossover, double-blind study

    PubMed Central

    2010-01-01

    Background Interferon (IFN) alpha conjugation to polyethylene glycol (PEG) results in a better pharmacokinetic profile and efficacy. The aim of this study was to compare the pharmacokinetic, pharmacodynamic and safety properties of a new, locally developed, 40-kDa PEG-IFN alpha-2b preparation with a reference, commercially available PEG-IFN alpha-2a in healthy male volunteers. Methods A randomized, crossover, double-blind study with a 3-weeks washout period, was done. A single 180 micrograms PEG-IFN alpha-2 dose was administered subcutaneously in both groups. Sixteen apparently healthy male subjects were included. Serum PEG-IFN concentration was measured during 336 hours by an enzyme immunoassay (EIA). Other clinical and laboratory variables were used as pharmacodynamic and safety criteria. Results The pharmacokinetic comparison by EIA yielded a high similitude between the formulations. In spite of a high subject variability, the parameters' mean were very close (in all cases p > 0.05): AUC: 53623 vs. 44311 pg.h/mL; Cmax: 333 vs. 271 pg/mL; Tmax: 54 vs. 55 h; half-life (t1/2): 72.4 vs. 64.8 h; terminal elimination rate (lambda): 0.011 vs. 0.014 h-1; mean residence time (MRT): 135 vs. 123 h for reference and study preparations, respectively. There were no significant differences with respect to the pharmacodynamic variables either: serum neopterin and beta-2 microglobulin levels, stimulation of 2'5' oligoadenylate synthetase expression, and serum IFN antiviral activity. A strong Spearman's rank order correlation (p < 0.01) between the pharmacokinetic and pharmacodynamic concentration-time curves was observed. Both products caused similar leukocyte counts diminution and had similar safety profiles. The most frequent adverse reactions were leukopenia, fever, thrombocytopenia, transaminases increase and asthenia, mostly mild. Conclusions Both formulations are fully comparable from the pharmacokinetic, pharmacodynamic, and safety profiles. Efficacy trials can be carried

  16. Pharmacokinetic Profiles of Active Ingredients and Its Metabolites Derived from Rikkunshito, a Ghrelin Enhancer, in Healthy Japanese Volunteers: A Cross-Over, Randomized Study

    PubMed Central

    Kitagawa, Hiroyuki; Munekage, Masaya; Matsumoto, Takashi; Sadakane, Chiharu; Fukutake, Miwako; Aoki, Katsuyuki; Watanabe, Junko; Maemura, Kazuya; Hattori, Tomohisa; Kase, Yosio; Uezono, Yasuhito; Inui, Akio; Hanazaki, Kazuhiro

    2015-01-01

    Background Rikkunshito, a traditional Japanese (Kampo) medicine, has been used to treat upper gastrointestinal disorders such as functional dyspepsia and gastroesophageal reflux. This study investigated the exposure and pharmacokinetics of the ingredients of rikkunshito in healthy volunteers. Methods and Results First, an exploratory nonrandomized, open-label, one-period, noncrossover study using four healthy Japanese volunteers to detect 32 typical ingredients of rikkunshito in plasma and urine. As a result, 18 or 21 of 32 ingredients was detected in plasma or urine samples after oral administration of rikkunshito (7.5 g/day). Furthermore, a randomized, open-label, three-arm, three-period, crossover study using 21 subjects was conducted to determine the amounts of exposure and pharmacokinetic parameters of nine ingredients derived from rikkunshito (atractylodin, atractylodin carboxylic acid, pachymic acid, 3,3′,4′,5,6,7,8-heptamethoxyflavone, naringenin, nobiletin, liquiritigenin, isoliquiritigenin, and 18β-glycyrrhetinic acid) after oral administration of rikkunshito at three different doses (2.5, 5.0, or 7.5 g/day) during each period. The pharmacokinetic profiles of the nine ingredients in plasma were characterized. The geometric means (95% confidence interval) for the Cmax of the ingredients at a dose of 7.5 g were 1570 (1210–2040), 14,300 (12,200–16,800), 91.0 (71.8–115), 105 (75.6–144), 1150 (802–1650), 35.9 (24.6–52.5), 800 (672–952), 42.8 (30.4–60.3), and 55,600 (39,600–78,100) pg/mL, respectively, and for the AUC0–last were 1760 (1290–2390), 12700 (11,100–14,600), 1210 (882–1650), 225 (157–322), 4630 (2930–7320), 35.7 (20.4–62.7), 4040 (3260–5010), 122 (88.2–168), and 832,000 (628,000–1,100,000) pg·h/mL respectively. Conclusions We identified the ingredients of rikkunshito that are absorbed in humans. Furthermore, we determined the pharmacokinetics of nine ingredients derived from rikkunshito. This information

  17. Efficacy of a Mandibular Advancement Appliance on Sleep Disordered Breathing in Children: A Study Protocol of a Crossover Randomized Controlled Trial

    PubMed Central

    Idris, Ghassan; Galland, Barbara; Robertson, Christopher J.; Farella, Mauro

    2016-01-01

    Background: Sleep-Disordered Breathing (SDB) varies from habitual snoring to partial or complete obstruction of the upper airway and can be found in up to 10% of children. SDB can significantly affect children's wellbeing, as it can cause growth disorders, educational and behavioral problems, and even life-threatening conditions, such as cardiorespiratory failure. Adenotonsillectomy represents the primary treatment for pediatric SDB where adeno-tonsillar hypertrophy is indicated. For those with craniofacial anomalies, or for whom adenotonsillectomy or other treatment modalities have failed, or surgery is contra-indicated, mandibular advancement splints (MAS) may represent a viable treatment option. Whilst the efficacy of these appliances has been consistently demonstrated in adults, there is little information about their effectiveness in children. Aims: To determine the efficacy of mandibular advancement appliances for the management of SDB and related health problems in children. Methods/design: The study will be designed as a single-blind crossover randomized controlled trial with administration of both an “Active MAS” (Twin-block) and a “Sham MAS.” Eligible participants will be children aged 8–12 years whose parents report they snore ≥3 nights per week. Sixteen children will enter the full study after confirming other inclusion criteria, particularly Skeletal class I or class II confirmed by lateral cephalometric radiograph. Each child will be randomly assigned to either a treatment sequence starting with the Active or the Sham MAS. Participants will wear the appliances for 3 weeks separated by a 2-week washout period. For each participant, home-based polysomnographic data will be collected four times; once before and once after each treatment period. The Apnea Hypopnea Index (AHI) will represent the main outcome variable. Secondary outcomes will include, snoring frequency, masseter muscle activity, sleep symptoms, quality of life, daytime

  18. The effects of anatabine on non-invasive indicators of muscle damage: a randomized, double-blind, placebo-controlled, crossover study

    PubMed Central

    2013-01-01

    Background Anatabine (ANA), a minor tobacco alkaloid found in the Solanaceae family of plants, may exhibit anti-inflammatory activity, which may be useful to aid in recovery from exercise-induced muscle damage. The purpose of this study, therefore, was to examine the effects of ANA supplementation on the recovery of isometric strength and selected non-invasive indicators of muscle damage. Methods A double-blinded, placebo-controlled, crossover design was used to study eighteen men (mean ± SD age = 22.2 ± 3.1 yrs; body mass = 80.3 ± 15.7 kg) who participated in two randomly-ordered conditions separated by a washout period. The ANA condition consisted of consuming 6–12 mg anatabine per day for 10 days, while testing took place during days 7–10. The placebo (PLA) condition was identical except that the PLA supplement contained no ANA. Maximal voluntary isometric peak torque (PT) of the forearm flexors, arm circumference, hanging joint angle, and subjective pain ratings were measured before (PRE), immediately after (POST), and 24, 48, and 72 h after six sets of 10 maximal, eccentric isokinetic forearm flexion muscle actions. Resting heart rate and blood pressure were measured at PRE and 72 h in each condition. Results For PT, hanging joint angle, arm circumference, and subjective pain ratings, there were no condition x time (p > 0.05) interactions, there were no main effects for condition (p > 0.05), but there were main effects for time (p < 0.001). There were no condition x time (p > 0.05) interactions and no main effects for condition (p > 0.05) or time (p > 0.05) for blood pressure or resting heart rate. Conclusions ANA supplementation had no effect on the recovery of muscle strength, hanging joint angle, arm swelling, or subjective pain ratings after a bout of maximal eccentric exercise in the forearm flexors. Therefore, ANA may not be beneficial for those seeking to improve recovery from heavy eccentric

  19. AKL1, a botanical mixture for the treatment of asthma: a randomised, double-blind, placebo-controlled, cross-over study

    PubMed Central

    Thomas, Michael; Sheran, Jane; Smith, Natalie; Fonseca, Sofia; Lee, Amanda J

    2007-01-01

    Background Despite effective treatments, asthma outcomes remain suboptimal. Interest exists in complementary therapies, particularly in herbal remedies for asthma treatment, currently with inconclusive evidence of efficacy. The encapsulated botanical mixture AKL1 has anecdotal evidence of effectiveness in asthma. Methods We performed a randomised controlled cross over study comparing the effectiveness of AKL1 with indistinguishable placebo as add-on therapy in patients uncontrolled on standard asthma treatment. Thirty two adult asthmatics completed a 36 week trial consisting of a 4 week single blind run in period, during which placebo was added to usual treatment, a 12 week double blind active phase in which subjects received AKL1 or placebo, a single blind 8 week washout period receiving placebo and a final 12 week double blind cross-over active treatment phase. Daily diaries were kept of peak expiratory flow and symptoms, and spirometry, validated symptom and health status questionnaire scores and adverse events were monitored at study visits. Paired T tests were used to compare the effects of placebo and AKL1 on outcomes. Changes in outcome measures over treatment phases are presented as means and 95% confidence intervals (CI) of means. Results No significant differences in lung function (active-placebo) were found (Forced Expiratory Volume in 1 second: mean difference [95% CI] = 0.01 [-0.12 to 0.14] L, p = 0.9. Peak Expiratory Flow: -4.08 [-35.03 to 26.89]. L/min, p = 0.8). Trends to clinical improvements favouring active treatment were however consistently seen in the patient-centered outcomes: Asthma Control Questionnaire mean difference (active – placebo) [95% CI] = -0.35 [-0.78 to 0.07], p = 0.10, Asthma Quality of Life Questionnaire mean difference 0.42 [-0.08 to 0.93], p = 0.09, Leicester Cough Questionnaire mean difference 0.49, [-0.18 to 1.16], p = 0.15. Nine exacerbations occurred during placebo treatment and five whilst on AKL1. No significant

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

    PubMed Central

    2010-01-01

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

  1. Efficacy and Safety of Modified Pranlukast (Prakanon®) Compared with Pranlukast (Onon®): A Randomized, Open-Label, Crossover Study

    PubMed Central

    Kim, Seo W.; Kim, Hunam; Ryu, Yon J.; Lee, Jin H.; Shim, Sung S.; Kim, Yoo K.; Chang, Jung H.

    2016-01-01

    Introduction: Pranlukast is a leukotriene receptor antagonist (LTRA) that is used as an additional controller of mild to moderate asthma. This study compared the efficacy and side effects of two bioequivalent preparations of pranlukast: original pranlukast (Onon®; Ono Pharmaceutical, Japan) and a modified formulation of pranlukast (Prakanon®; Yuhan Co, Korea) in patients with mild to moderate asthma. Methods: Of the 34 subjects screened, 30 patients who were using standard medication to control asthma and scored less than 20 points on the Asthma Control Test™ (ACT) were assigned randomly to one of the two groups in a prospective, open label, crossover study: group 1 received Prakanon® (150 mg/day) and group 2 received Onon® (450 mg/day) for 8 weeks each; after a 1-week rest period, the groups were switched to the alternative medication for further 8 weeks and monitored for 2 more weeks without study medication. Evaluation parameters included the ACT, quality of life questionnaire adult Korean asthmatics (QLQAKA), pulmonary function tests, peripheral blood tests, vital signs, and adverse events. Results: Thirty patients were enrolled and 21 completed the trial: 10 in group 1 and 11 in group 2. The baseline data of the two groups did not differ. No statistical significant differences were observed in efficacy and lung function at each time and in changes from baseline value between the two kinds of pranlukast. The final asthma control rate was 81% with Prakanon® and 76% with Onon®. There were no differences in vital signs and laboratory data at each time and in changes from baseline value between the two drugs. There were no differences in adverse events between the two drugs. The most common side effect was abdominal pain. Drug compliance was high, without differences between the two drugs. Conclusion: These findings suggest that Prakanon® which is an improved formulation of pranlukast at a lower dose than the original formulation, Onon®, has a similar

  2. Fine-Scale Crossover Rate Variation on the Caenorhabditis elegans X Chromosome

    PubMed Central

    Bernstein, Max R.; Rockman, Matthew V.

    2016-01-01

    Meiotic recombination creates genotypic diversity within species. Recombination rates vary substantially across taxa, and the distribution of crossovers can differ significantly among populations and between sexes. Crossover locations within species have been found to vary by chromosome and by position within chromosomes, where most crossover events occur in small regions known as recombination hotspots. However, several species appear to lack hotspots despite significant crossover heterogeneity. The nematode Caenorhabditis elegans was previously found to have the least fine-scale variation in crossover distribution among organisms studied to date. It is unclear whether this pattern extends to the X chromosome given its unique compaction through the pachytene stage of meiotic prophase in hermaphrodites. We generated 798 recombinant nested near-isogenic lines (NILs) with crossovers in a 1.41 Mb region on the left arm of the X chromosome to determine if its recombination landscape is similar to that of the autosomes. We find that the fine-scale variation in crossover rate is lower than that of other model species, and is inconsistent with hotspots. The relationship of genomic features to crossover rate is dependent on scale, with GC content, histone modifications, and nucleosome occupancy being negatively associated with crossovers. We also find that the abundances of 4- to 6-bp DNA motifs significantly explain crossover density. These results are consistent with recombination occurring at unevenly distributed sites of open chromatin. PMID:27172189

  3. Dimer Involvement and Origin of Crossover in Nickel-Catalyzed Aldehyde–Alkyne Reductive Couplings

    PubMed Central

    2015-01-01

    The mechanism of nickel(0)-catalyzed reductive coupling of aldehydes and alkynes has been studied. Extensive double-labeling crossover studies have been conducted. While previous studies illustrated that phosphine- and N-heterocyclic carbene-derived catalysts exhibited differing behavior, the origin of these effects has now been evaluated in detail. Many variables, including ligand class, sterics of the ligand and alkyne, temperature, and ring size being formed in intramolecular versions, all influence the extent of crossover observed. A computational evaluation of these effects suggests that dimerization of a key metallacyclic intermediate provides the origin of crossover. Protocols that proceed with crossover are typically less efficient than those without crossover given the thermodynamic stability and low reactivity of the dimeric metallacycles involved in crossover pathways. PMID:25401337

  4. Impact of a Telenursing service on satisfaction and health outcomes of children with inflammatory rheumatic diseases and their families: a crossover randomized trial study protocol

    PubMed Central

    2014-01-01

    Background Pediatric rheumatic diseases have a significant impact on children’s quality of life and family functioning. Disease control and management of the symptoms are important to minimize disability and pain. Specialist clinical nurses play a key role in supporting medical teams, recognizing poor disease control and the need for treatment changes, providing a resource to patients on treatment options and access to additional support and advice, and identifying best practices to achieve optimal outcomes for patients and their families. This highlights the importance of investigating follow-up telenursing (TN) consultations with experienced, specialist clinical nurses in rheumatology to provide this support to children and their families. Methods/Design This randomized crossover, experimental longitudinal study will compare the effects of standard care against a novel telenursing consultation on children’s and family outcomes. It will examine children below 16 years old, recently diagnosed with inflammatory rheumatic diseases, who attend the pediatric rheumatology outpatient clinic of a tertiary referral hospital in western Switzerland, and one of their parents. The telenursing consultation, at least once a month, by a qualified, experienced, specialist nurse in pediatric rheumatology will consist of providing affective support, health information, and aid to decision-making. Cox’s Interaction Model of Client Health Behavior serves as the theoretical framework for this study. The primary outcome measure is satisfaction and this will be assessed using mixed methods (quantitative and qualitative data). Secondary outcome measures include disease activity, quality of life, adherence to treatment, use of the telenursing service, and cost. We plan to enroll 56 children. Discussion The telenursing consultation is designed to support parents and children/adolescents during the course of the disease with regular follow-up. This project is novel because it is based

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

    PubMed

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

    2015-12-01

    Standard spyrometric assessment in chronic obstructive pulmonary disease (COPD) only evaluates bronchial obstruction. However, airflow limitation and hyperinflation are the main pathophysiological factors responsible for dyspnoea and reduced exercise tolerance in patients with COPD. This study evaluated the effects of aclidinium bromide 400 μg and glycopyrronium bromide 50 μg on these parameters. Patients with stable severe/very severe COPD were randomized in this double-blind, double-dummy, crossover, Phase IV study. Patients received single doses of each drug on separate days. Primary endpoints were changes in residual volume (RV) and intra-thoracic gas volume (ITGV), assessed by full-body plethysmography. Other endpoints included changes variations in lung ventilation inhomogeneity (Phase III slope of single-breath nitrogen washout test, SBN2), dyspnoea visual analogue scale, and pulmonary specific total airway resistances. Assessments were performed at baseline and 5, 15, 30, 60, and 180 min post-administration. Thirty-seven patients were randomized (31 male; mean age 71 years). Aclidinium and glycopyrronium significantly improved ITGV versus baseline at all-time points (p < 0.05). Significant improvements in RV were observed after 5 min with aclidinium and after 60 min with glycopyrronium. RV improvements were significantly greater with aclidinium than glycopyrronium from 5 to 60 min post-administration (p < 0.05). Both treatments improved dyspnoea versus baseline at all-time points (p < 0.05). Aclidinium significantly improved ventilation inhomogeneity versus baseline at all-time points; no significant changes were observed for glycopyrronium. For the first time two long-acting muscarinic antagonists have been compared in acute conditions with body plethysmography and SBN2 test. We demonstrated that both aclidinium and glycopyrronium significantly reduce hyperinflation and dyspnoea in severe and very severe COPD patients. Aclidinium however

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

    PubMed Central

    Melzer, Itshak; Elbar, Ori; Tsedek, Irit; Oddsson, Lars IE

    2008-01-01

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

  7. Bioavailability of cyanide after consumption of a single meal of foods containing high levels of cyanogenic glycosides: a crossover study in humans.

    PubMed

    Abraham, Klaus; Buhrke, Thorsten; Lampen, Alfonso

    2016-03-01

    The acute toxicity of cyanide is determined by its peak levels reached in the body. Compared to the ingestion of free cyanide, lower peak levels may be expected after consumption of foods containing cyanogenic glycosides with the same equivalent dose of cyanide. This is due to possible delayed and/or incomplete release of cyanide from the cyanogenic glycosides depending on many factors. Data on bioavailability of cyanide after consumption of foods containing high levels of cyanogenic glycosides as presented herein were necessary to allow a meaningful risk assessment for these foods. A crossover study was carried out in 12 healthy adults who consumed persipan paste (equivalent total cyanide: 68 mg/kg), linseed (220 mg/kg), bitter apricot kernels (about 3250 mg/kg), and fresh cassava roots (76-150 mg/kg), with each "meal" containing equivalents of 6.8 mg cyanide. Cyanide levels were determined in whole blood using a GC-MS method with K(13)C(15)N as internal standard. Mean levels of cyanide at the different time points were highest after consumption of cassava (15.4 µM, after 37.5 min) and bitter apricot kernels (14.3 µM, after 20 min), followed by linseed (5.7 µM, after 40 min) and 100 g persipan (1.3 µM, after 105 min). The double dose of 13.6 mg cyanide eaten with 200 g persipan paste resulted in a mean peak level of 2.9 µM (after 150 min). An acute reference dose of 0.075 mg/kg body weight was derived being valid for a single application/meal of cyanides or hydrocyanic acid as well as of unprocessed foods with cyanogenic glycosides also containing the accompanying intact β-glucosidase. For some of these foods, this approach may be overly conservative due to delayed release of cyanide, as demonstrated for linseed. In case of missing or inactivated β-glucosidase, the hazard potential is much lower. PMID:25708890

  8. The rate ratio of injury and aggressive incident for alcohol alone, cocaine alone and simultaneous use before the event: A case-crossover study

    PubMed Central

    Zhao, Jinhui; Macdonald, Scott; Borges, Guilherme; Joordens, Chantele; Stockwell, Tim; Ye, Yu

    2015-01-01

    Objectives (i) To estimate the Rate Ratio (RR) of use of alcohol alone, cocaine alone, and both substances simultaneously on acute injury or an aggressive incident, (ii) To compare the RRs for simultaneous use within 3 or 6 hours of the event; and (iii) To compare the RRs of two measures of exposure, “hours of feeling effects” versus estimates based on self-reported quantity and frequency of use. Methods The study employed a case-crossover design with the frequency approach. Clients (N=616) in substance abuse treatment for alcohol or cocaine issues from 2009 to 2012 completed a self-administered questionnaire on their substance use within 3 and 6 hours before a recent injury or physically aggressive incident. Clients also reported detailed quantity and frequency information in relation to their typical substance use, as well as information on “feeling effects”. The RR of acute harms due to substance use was estimated using the Mantel-Haenszel estimator. Results In the 6-hour window before the event, use of cocaine alone, alcohol alone and simultaneous alcohol and cocaine use were each significantly (P <0.05) related to a recent injury and aggressive incident. Simultaneous use was not significantly greater than use of either drug alone. Estimates of RR based on simultaneous use for a 3-hour window before the event were consistently larger than those based on a 6-hour window, and comparisons were significant (P <0.05) for an aggressive incident but not an injury. With reference to the two measures of exposure, three of eight comparisons of RRs were significantly larger for feeling the effects of the substance in comparison to quantity and frequency of substance use. Conclusion These findings are consistent with increased likelihood of harms related to the acute effects of alcohol alone, cocaine alone or simultaneous use. The results are suggestive that the acute effects of these drugs may be better measured within a 3-hour time window than a 6-hour window

  9. A Web-Based Telehealth Training Platform Incorporating Automated Nonverbal Behavior Feedback for Teaching Communication Skills to Medical Students: A Randomized Crossover Study

    PubMed Central

    2016-01-01

    Background In the interests of patient health outcomes, it is important for medical students to develop clinical communication skills. We previously proposed a telehealth communication skills training platform (EQClinic) with automated nonverbal behavior feedback for medical students, and it was able to improve medical students’ awareness of their nonverbal communication. Objective This study aimed to evaluate the effectiveness of EQClinic to improve clinical communication skills of medical students. Methods We conducted a 2-group randomized crossover trial between February and June 2016. Participants were second-year medical students enrolled in a clinical communication skills course at an Australian university. Students were randomly allocated to complete online EQClinic training during weeks 1–5 (group A) or to complete EQClinic training during weeks 8–11 (group B). EQClinic delivered an automated visual presentation of students’ nonverbal behavior coupled with human feedback from a standardized patient (SP). All students were offered two opportunities to complete face-to-face consultations with SPs. The two face-to-face consultations were conducted in weeks 6–7 and 12–13 for both groups, and were rated by tutors who were blinded to group allocation. Student-Patient Observed Communication Assessment (SOCA) was collected by blinded assessors (n=28) at 2 time points and also by an SP (n=83). Tutor-rated clinical communications skill in face-to-face consultations was the primary outcome and was assessed with the SOCA. We used t tests to examine the students’ performance during face-to-face consultations pre- and postexposure to EQClinic. Results We randomly allocated 268 medical students to the 2 groups (group A: n=133; group B: n=135). SOCA communication skills measures (score range 4–16) from the first face-to-face consultation were significantly higher for students in group A who had completed EQClinic training and reviewed the nonverbal behavior

  10. Effects of a Brown Beans Evening Meal on Metabolic Risk Markers and Appetite Regulating Hormones at a Subsequent Standardized Breakfast: A Randomized Cross-Over Study

    PubMed Central

    Nilsson, Anne; Johansson, Elin; Ekström, Linda; Björck, Inger

    2013-01-01

    Background Dietary prevention strategies are increasingly recognized as essential to combat the current epidemic of obesity and related metabolic disorders. The purpose of the present study was to evaluate the potential prebiotic effects of indigestible carbohydrates in Swedish brown beans (Phaseolus vulgaris var. nanus) in relation to cardiometabolic risk markers and appetite regulating hormones. Methods Brown beans, or white wheat bread (WWB, reference product) were provided as evening meals to 16 healthy young adults in a randomised crossover design. Glucose, insulin, appetite regulatory hormones, GLP-1, GLP-2, appetite sensations, and markers of inflammation were measured at a following standardised breakfast, that is at 11 to 14 h post the evening meals. Additionally, colonic fermentation activity was estimated from measurement of plasma short chain fatty acids (SCFA, including also branched chain fatty acids) and breath hydrogen (H2) excretion. Results An evening meal of brown beans, in comparison with WWB, lowered blood glucose (−15%, p<0.01)- and insulin (−16%, p<0.05) responses, increased satiety hormones (PYY 51%, p<0.001), suppressed hunger hormones (ghrelin −14%, p<0.05), and hunger sensations (−15%, p = 0.05), increased GLP-2 concentrations (8.4%, p<0.05) and suppressed inflammatory markers (IL-6 −35%, and IL-18 −8.3%, p<0.05) at a subsequent standardised breakfast. Breath H2 (141%, p<0.01), propionate (16%, p<0.05), and isobutyrate (18%, P<0.001) were significantly increased after brown beans compared to after WWB, indicating a higher colonic fermentative activity after brown beans. Conclusions An evening meal with brown beans beneficially affected important measures of cardiometabolic risk and appetite regulatory hormones, within a time frame of 11–14 h, in comparison to a WWB evening meal. Concentrations of plasma SCFA and H2 were increased, indicating involvement of colonic fermentation. Indigestible colonic substrates from brown

  11. Bioavailability of cyanide after consumption of a single meal of foods containing high levels of cyanogenic glycosides: a crossover study in humans.

    PubMed

    Abraham, Klaus; Buhrke, Thorsten; Lampen, Alfonso

    2016-03-01

    The acute toxicity of cyanide is determined by its peak levels reached in the body. Compared to the ingestion of free cyanide, lower peak levels may be expected after consumption of foods containing cyanogenic glycosides with the same equivalent dose of cyanide. This is due to possible delayed and/or incomplete release of cyanide from the cyanogenic glycosides depending on many factors. Data on bioavailability of cyanide after consumption of foods containing high levels of cyanogenic glycosides as presented herein were necessary to allow a meaningful risk assessment for these foods. A crossover study was carried out in 12 healthy adults who consumed persipan paste (equivalent total cyanide: 68 mg/kg), linseed (220 mg/kg), bitter apricot kernels (about 3250 mg/kg), and fresh cassava roots (76-150 mg/kg), with each "meal" containing equivalents of 6.8 mg cyanide. Cyanide levels were determined in whole blood using a GC-MS method with K(13)C(15)N as internal standard. Mean levels of cyanide at the different time points were highest after consumption of cassava (15.4 µM, after 37.5 min) and bitter apricot kernels (14.3 µM, after 20 min), followed by linseed (5.7 µM, after 40 min) and 100 g persipan (1.3 µM, after 105 min). The double dose of 13.6 mg cyanide eaten with 200 g persipan paste resulted in a mean peak level of 2.9 µM (after 150 min). An acute reference dose of 0.075 mg/kg body weight was derived being valid for a single application/meal of cyanides or hydrocyanic acid as well as of unprocessed foods with cyanogenic glycosides also containing the accompanying intact β-glucosidase. For some of these foods, this approach may be overly conservative due to delayed release of cyanide, as demonstrated for linseed. In case of missing or inactivated β-glucosidase, the hazard potential is much lower.

  12. Monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, and curcumin: a randomized, double-blind placebo-controlled cross-over 4g study and an open-label 8g extension study.

    PubMed

    Golombick, Terry; Diamond, Terrence H; Manoharan, Arumugam; Ramakrishna, Rajeev

    2012-05-01

    Monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM) represent useful models for studying multiple myeloma precursor disease, and for developing early intervention strategies. Administering a 4g dose of curcumin, we performed a randomised, double-blind placebo-controlled cross-over study, followed by an open-label extension study using an 8g dose to assess the effect of curcumin on FLC response and bone turnover in patients with MGUS and SMM. 36 patients (19 MGUS and 17 SMM) were randomised into two groups: one received 4g curcumin and the other 4g placebo, crossing over at 3 months. At completion of the 4g arm, all patients were given the option of entering an open-label, 8g dose extension study. Blood and urine samples were collected at specified intervals for specific marker analyses. Group values are expressed as mean ± 1 SD. Data from different time intervals within groups were compared using Student's paired t-test. 25 patients completed the 4g cross-over study and 18 the 8g extension study. Curcumin therapy decreased the free light-chain ratio (rFLC), reduced the difference between clonal and nonclonal light-chain (dFLC) and involved free light-chain (iFLC). uDPYD, a marker of bone resorption, decreased in the curcumin arm and increased on the placebo arm. Serum creatinine levels tended to diminish on curcumin therapy. These findings suggest that curcumin might have the potential to slow the disease process in patients with MGUS and SMM. PMID:22473809

  13. Dimensional crossover in semiconductor nanostructures

    NASA Astrophysics Data System (ADS)

    McDonald, Matthew P.; Chatterjee, Rusha; Si, Jixin; Jankó, Boldizsár; Kuno, Masaru

    2016-08-01

    Recent advances in semiconductor nanostructure syntheses provide unprecedented control over electronic quantum confinement and have led to extensive investigations of their size- and shape-dependent optical/electrical properties. Notably, spectroscopic measurements show that optical bandgaps of one-dimensional CdSe nanowires are substantially (approximately 100 meV) lower than their zero-dimensional counterparts for equivalent diameters spanning 5-10 nm. But what, exactly, dictates the dimensional crossover of a semiconductor's electronic structure? Here we probe the one-dimensional to zero-dimensional transition of CdSe using single nanowire/nanorod absorption spectroscopy. We find that carrier electrostatic interactions play a fundamental role in establishing dimensional crossover. Moreover, the critical length at which this transition occurs is governed by the aspect ratio-dependent interplay between carrier confinement and dielectric contrast/confinement energies.

  14. Dimensional crossover in semiconductor nanostructures

    PubMed Central

    McDonald, Matthew P.; Chatterjee, Rusha; Si, Jixin; Jankó, Boldizsár; Kuno, Masaru

    2016-01-01

    Recent advances in semiconductor nanostructure syntheses provide unprecedented control over electronic quantum confinement and have led to extensive investigations of their size- and shape-dependent optical/electrical properties. Notably, spectroscopic measurements show that optical bandgaps of one-dimensional CdSe nanowires are substantially (approximately 100 meV) lower than their zero-dimensional counterparts for equivalent diameters spanning 5–10 nm. But what, exactly, dictates the dimensional crossover of a semiconductor's electronic structure? Here we probe the one-dimensional to zero-dimensional transition of CdSe using single nanowire/nanorod absorption spectroscopy. We find that carrier electrostatic interactions play a fundamental role in establishing dimensional crossover. Moreover, the critical length at which this transition occurs is governed by the aspect ratio-dependent interplay between carrier confinement and dielectric contrast/confinement energies. PMID:27577091

  15. Dimensional crossover in semiconductor nanostructures.

    PubMed

    McDonald, Matthew P; Chatterjee, Rusha; Si, Jixin; Jankó, Boldizsár; Kuno, Masaru

    2016-01-01

    Recent advances in semiconductor nanostructure syntheses provide unprecedented control over electronic quantum confinement and have led to extensive investigations of their size- and shape-dependent optical/electrical properties. Notably, spectroscopic measurements show that optical bandgaps of one-dimensional CdSe nanowires are substantially (approximately 100 meV) lower than their zero-dimensional counterparts for equivalent diameters spanning 5-10 nm. But what, exactly, dictates the dimensional crossover of a semiconductor's electronic structure? Here we probe the one-dimensional to zero-dimensional transition of CdSe using single nanowire/nanorod absorption spectroscopy. We find that carrier electrostatic interactions play a fundamental role in establishing dimensional crossover. Moreover, the critical length at which this transition occurs is governed by the aspect ratio-dependent interplay between carrier confinement and dielectric contrast/confinement energies. PMID:27577091

  16. Topological crossovers near a quantum critical point

    NASA Astrophysics Data System (ADS)

    Khodel, V. A.; Clark, J. W.; Zverev, M. V.

    2011-09-01

    We study the temperature evolution of the single-particle spectrum ɛ-( p) and quasiparticle momentum distribution n( p) of homogeneous strongly correlated Fermi systems beyond a point where the necessary condition for stability of the Landau state is violated, and the Fermi surface becomes multi-connected by virtue of a topological crossover. Attention is focused on the different non-Fermi-liquid temperature regimes experienced by a phase exhibiting a single additional hole pocket compared with the conventional Landau state. A critical experiment is proposed to elucidate the origin of NFL behavior in dense films of liquid 3He.

  17. Feshbach resonances and BCS-BEC crossover in optical lattices

    NASA Astrophysics Data System (ADS)

    Shen, Zhaochuan; Radzihovsky, Leo; Gurarie, Victor

    2012-02-01

    In this talk we study Feshbach resonances of fermionic atoms placed in a periodic potential. We investigate the criteria when such a system can be described by a Hubbard model with variable interaction strength in case of broad resonance, or by a tight binding model of atoms and molecules with can convert into each other on sites of the lattice in case of narrow resonances. Assuming the applicability of these models, we first study the BCS-BEC crossover for broad resonance. We find that while below half filling the system undergoes the conventional crossover from a BCS superconductor to a Bose condensate of molecules, above half filling the nature of the BEC phase changes to that of a condensate of molecules made of holes. Switching our attention to the case of narrow resonance, we find that the crossover takes the system from a BCS to hole-BEC regime, than back to BCS, and finally to a conventional BEC of atomic molecules. In the latter crossover, we find that the size of Cooper pairs/molecules changes non-monotonously, being larger in the BCS and smaller in the BEC regimes. Finally, at a unity filling we find a quantum phase transition from a band insulator to a BCS-BEC superfluid replacing the crossover.

  18. Pharmacokinetics and Bioequivalence of Two Formulations of Febuxostat 40-Mg and 80-Mg Tablets: A Randomized, Open-Label, 4-Way Crossover Study in Healthy Chinese Male Volunteers

    PubMed Central

    Luo, Zhu; Nan, Feng; Miao, Jia; Chen, Zhihui; Li, Mei; Liang, Maozhi

    2016-01-01

    The present study aimed to investigate the pharmacokinetic properties of febuxostat in healthy Chinese male volunteers and evaluate whether the two formulations of febuxostat 40-mg and 80-mg tablets are bioequivalent. A randomized, open-label, 4-way crossover study was conducted in healthy Chinese male volunteers under fasting conditions. 24 eligible subjects were randomized in a 1:1:1:1 ratio to receive a single dose of test or reference formulation of febuxostat 40-mg or 80-mg tablet. The washout period between each administration was 1 week. Plasma febuxostat was quantified by a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Tolerability was evaluated by monitoring adverse events, physical examinations, 12-lead ECG and laboratory tests. After single-dosing of 1 tablet of 40-mg febuxostat, the pharmacokinetic parameters of test and reference formulations were: Tmax 1.22±0.87 and 1.85±1.03 h, Cmax 1689.16±461.31 and 1613.80±608.43 ng·mL-1, AUC0-t 5139.87±1349.28 and 5517.91±2024.26 ng·mL-1·h, AUC0−∞ 5263.06±1339.16 and 5640.48±2040.22 ng·mL-1·h, t1/2 4.82±2.61 and 4.85±1.78 h, respectively. After single-dosing of 1 tablet of 80-mg febuxostat, the pharmacokinetic parameters of test and reference formulations were: Tmax 1.71±1.21 and 2.23±1.55 h, Cmax 2744.47±1157.44 and 2998.17±1200.13 ng·mL-1, AUC0-t 9634.03±2768.25 and 10467.95±3501.65 ng·mL-1·h, AUC0−∞ 9834.32±2730.51 and 10626.63±3504.08 ng·mL-1·h, t1/2 6.25±2.44 and 5.46±1.65 h, respectively. For single-dosing of 1 tablet of 40-mg febuxostat, 90% CIs for the test/reference ratio of AUC0-t, AUC0−∞ and Cmax were 89.79 to 102.55, 90.14 to 102.56 and 93.99 to 129.63, respectively. For single-dosing of 1 tablet of 80-mg febuxostat, 90% CIs for the test/reference ratio of AUC0-t, AUC0−∞ and Cmax were 86.67 to 100.00, 87.50 to 100.51 and 79.48 to 105.99, respectively. This single dose study revealed similar pharmacokinetic properties in

  19. An Analysis of Semantic Aware Crossover

    NASA Astrophysics Data System (ADS)

    Uy, Nguyen Quang; Hoai, Nguyen Xuan; O'Neill, Michael; McKay, Bob; Galván-López, Edgar

    It is well-known that the crossover operator plays an important role in Genetic Programming (GP). In Standard Crossover (SC), semantics are not used to guide the selection of the crossover points, which are generated randomly. This lack of semantic information is the main cause of destructive effects from SC (e.g., children having lower fitness than their parents). Recently, we proposed a new semantic based crossover known GP called Semantic Aware Crossover (SAC) [25]. We show that SAC outperforms SC in solving a class of real-value symbolic regression problems. We clarify the effect of SAC on GP search in increasing the semantic diversity of the population, thus helping to reduce the destructive effects of crossover in GP.

  20. A new crossover sine model based on trigonometric model and its application to the crossover lattice equation of state

    NASA Astrophysics Data System (ADS)

    Lee, Yongjin; Shin, Moon Sam; Kim, Hwayong

    2008-12-01

    In this study, a new crossover sine model (CSM) n was developed from a trigonometric model [M. E. Fisher, S. Zinn, and P. J. Upton, Phys. Rev. B 59, 14533 (1999)]. The trigonometric model is a parametric formulation model that is used to represent the thermodynamic variables near a critical point. Although there are other crossover models based on this trigonometric model, such as the CSM and the analytical sine model, which is an analytic formulation of the CSM, the new sine model (NSM) employs a different approach from these two models in terms of the connections between the parametric variables of the trigonometric model and thermodynamic variables. In order to test the performance of the NSM, the crossover lattice equation of state [M. S. Shin, Y. Lee, and H. Kim, J. Chem. Thermodyn. 40, 174 (2008)] was applied using the NSM for correlations of various pure fluids and fluid mixtures. The results showed that over a wide range of states, the crossover lattice fluid (xLF)/NSM yields the saturated properties of pure fluids and the phase behavior of binary mixtures more accurately than the original lattice equation of state. Moreover, a comparison with the crossover lattice equation of state using the CSM (xLF/CSM) showed that the new model presents good correlation results that are comparable to the xLF/CSM.

  1. A new crossover sine model based on trigonometric model and its application to the crossover lattice equation of state.

    PubMed

    Lee, Yongjin; Shin, Moon Sam; Kim, Hwayong

    2008-12-21

    In this study, a new crossover sine model (CSM) n was developed from a trigonometric model [M. E. Fisher, S. Zinn, and P. J. Upton, Phys. Rev. B 59, 14533 (1999)]. The trigonometric model is a parametric formulation model that is used to represent the thermodynamic variables near a critical point. Although there are other crossover models based on this trigonometric model, such as the CSM and the analytical sine model, which is an analytic formulation of the CSM, the new sine model (NSM) employs a different approach from these two models in terms of the connections between the parametric variables of the trigonometric model and thermodynamic variables. In order to test the performance of the NSM, the crossover lattice equation of state [M. S. Shin, Y. Lee, and H. Kim, J. Chem. Thermodyn. 40, 174 (2008)] was applied using the NSM for correlations of various pure fluids and fluid mixtures. The results showed that over a wide range of states, the crossover lattice fluid (xLF)/NSM yields the saturated properties of pure fluids and the phase behavior of binary mixtures more accurately than the original lattice equation of state. Moreover, a comparison with the crossover lattice equation of state using the CSM (xLF/CSM) showed that the new model presents good correlation results that are comparable to the xLF/CSM.

  2. Crossover in the Efimov spectrum

    SciTech Connect

    Pricoupenko, Ludovic

    2010-10-15

    A filtering method is introduced for solving the zero-range three-boson problem. This scheme permits solving the original Skorniakov Ter-Martirosian integral equation for an arbitrary large ultraviolet cutoff and avoiding the Thomas collapse of the three particles. The method is applied to a more general zero-range model including a finite-background two-body scattering length and the effective range. A crossover in the Efimov spectrum is found in such systems and a specific regime emerges where Efimov states are long-lived.

  3. Universal entanglement crossover of coupled quantum wires

    NASA Astrophysics Data System (ADS)

    Vasseur, Romain; Jacobsen, Jesper; Saleur, Hubert

    2014-03-01

    We consider the entanglement between two one-dimensional quantum wires (Luttinger Liquids) coupled by tunneling through a quantum impurity. The physics of the system involves a crossover between weak and strong coupling regimes characterized by an energy scale TB, and methods of conformal field theory therefore cannot be applied. The evolution of the entanglement in this crossover has led to many numerical studies, but has remained little understood, analytically or even qualitatively. This is, in part, due to the fact that the entanglement in this case is non-perturbative in the tunneling amplitude. We argue that the correct universal scaling form of the entanglement entropy S (for an arbitrary interval containing the impurity) is ∂S / ∂lnL = f(LTB) . In the special case where the coupling to the impurity can be refermionized, we show how the universal function f(LTB) can be obtained analytically using recent results on form factors of twist fields and a defect massless-scattering formalism. Our results are carefully checked against numerical simulations. This work was supported by the the French ANR (ANR Projet 2010 Blanc SIMI 4 : DIME), the US DOE (grant number DE-FG03-01ER45908), the Quantum Materials program of LBNL (RV) and the Institut Universitaire de France (JLJ).

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

    PubMed

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

    2016-01-01

    This prospective randomized clinical crossover trial was designed to compare hypnosis and local anesthesia for experimental dental pain relief. Pain thresholds of the dental pulp were determined. A targeted standardized pain stimulus was applied and rated on the Visual Analogue Scale (0-10). The pain threshold was lower under hypnosis (58.3 ± 17.3, p < .001), maximal (80.0) under local anesthesia. The pain stimulus was scored higher under hypnosis (3.9 ± 3.8) than with local anesthesia (0.0, p < .001). Local anesthesia was superior to hypnosis and is a safe and effective method for pain relief in dentistry. Hypnosis seems to produce similar effects observed under sedation. It can be used in addition to local anesthesia and in individual cases as an alternative for pain control in dentistry.

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

    PubMed

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

    2016-01-01

    This prospective randomized clinical crossover trial was designed to compare hypnosis and local anesthesia for experimental dental pain relief. Pain thresholds of the dental pulp were determined. A targeted standardized pain stimulus was applied and rated on the Visual Analogue Scale (0-10). The pain threshold was lower under hypnosis (58.3 ± 17.3, p < .001), maximal (80.0) under local anesthesia. The pain stimulus was scored higher under hypnosis (3.9 ± 3.8) than with local anesthesia (0.0, p < .001). Local anesthesia was superior to hypnosis and is a safe and effective method for pain relief in dentistry. Hypnosis seems to produce similar effects observed under sedation. It can be used in addition to local anesthesia and in individual cases as an alternative for pain control in dentistry. PMID:27585724

  6. Crossover from Weakly to Strongly Correlated Regions in the Two-dimensional Hubbard Model — Off-diagonal Wave Function Monte Carlo Studies of Hubbard Model II —

    NASA Astrophysics Data System (ADS)

    Yanagisawa, Takashi

    2016-11-01

    The ground state of the two-dimensional (2D) Hubbard model is investigated by adopting improved wave functions that take into account intersite electron correlation beyond the Gutzwiller ansatz. The ground-state energy is lowered considerably, giving the best estimate of the ground-state energy for the 2D Hubbard model. There is a crossover from weakly to strongly correlated regions as the on-site Coulomb interaction U increases. The antiferromagnetic correlation induced by U is reduced for hole doping when U is large, being greater than the bandwidth, thus increasing the kinetic energy gain. The spin and charge fluctuations are induced in the strongly correlated region. These antiferromagnetic and kinetic charge fluctuations induce electron pairings, which results in high-temperature superconductivity.

  7. Spillover and Crossover of Exhaustion and Life Satisfaction among Dual-Earner Parents

    ERIC Educational Resources Information Center

    Demerouti, Evangelia; Bakker, Arnold B.; Schaufeli, Wilmar B.

    2005-01-01

    This study integrates spillover research of stress transferring from work to home and crossover research of strains transferring from one spouse to another. A spillover and crossover model was tested among 191 (couples of) dual-earner parents. For both males and females, it was hypothesized that (self-reported and partners' rating of)…

  8. Multiferroic crossover in perovskite oxides

    NASA Astrophysics Data System (ADS)

    Weston, L.; Cui, X. Y.; Ringer, S. P.; Stampfl, C.

    2016-04-01

    The coexistence of ferroelectricity and magnetism in A B O3 perovskite oxides is rare, a phenomenon that has become known as the ferroelectric "d0 rule." Recently, the perovskite BiCoO3 has been shown experimentally to be isostructural with PbTiO3, while simultaneously the d6Co3 + ion has a high-spin ground state with C -type antiferromagnetic ordering. It has been suggested that the hybridization of Bi 6 s states with the O 2 p valence band stabilizes the polar phase, however, we have recently demonstrated that Co3 + ions in the perovskite structure can facilitate a ferroelectric distortion via the Co 3 d -O 2 p covalent interaction [L. Weston, et al., Phys. Rev. Lett. 114, 247601 (2015), 10.1103/PhysRevLett.114.247601]. In this paper, using accurate hybrid density functional calculations, we investigate the atomic, electronic, and magnetic structure of BiCoO3 to elucidate the origin of the multiferroic state. To begin with, we perform a more general first-principles investigation of the role of d electrons in affecting the tendency for perovskite materials to exhibit a ferroelectric distortion; this is achieved via a qualitative trend study in artificial cubic and tetragonal La B O3 perovskites. We choose La as the A cation so as to remove the effects of Bi 6 s hybridization. The lattice instability is identified by the softening of phonon modes in the cubic phase, as well as by the energy lowering associated with a ferroelectric distortion. For the La B O3 series, where B is a d0-d8 cation from the 3 d block, the trend study reveals that increasing the d orbital occupation initially removes the tendency for a polar distortion, as expected. However, for high-spin d5-d7 and d8 cations a strong ferroelectric instability is recovered. This effect is explained in terms of increased pseudo-Jahn-Teller (PJT) p -d vibronic coupling. The PJT effect is described by the competition between a stabilizing force (K0) that favors the cubic phase, and a vibronic term that

  9. Unraveling the daily stress crossover between unemployed individuals and their employed spouses.

    PubMed

    Song, Zhaoli; Foo, Maw-Der; Uy, Marilyn A; Sun, Shuhua

    2011-01-01

    This study examined the dynamic relationship of distress levels between spouses when one is unemployed (and looking for a job) while the other is engaged in full-time employment. Using the diary survey method, we sampled 100 couples in China for 10 days and tested a model comprising three stress crossover mechanisms: the direct crossover, the mediating crossover, and the common stressor mechanisms. Results supported the direct crossover and common stressor mechanisms. Other stressors (e.g., work–family conflict and negative job search experience) were also related to distress of the unemployed individuals and their employed spouses. Additionally, we found a three-way interaction involving gender, marital satisfaction, and distress levels of employed spouses. We discuss how the study contributes to the unemployment and stress crossover literatures.

  10. 24 CFR 3285.701 - Electrical crossovers.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 24 Housing and Urban Development 5 2010-04-01 2010-04-01 false Electrical crossovers. 3285.701... URBAN DEVELOPMENT MODEL MANUFACTURED HOME INSTALLATION STANDARDS Electrical Systems and Equipment § 3285.701 Electrical crossovers. Multi-section homes with electrical wiring in more than one section...

  11. 24 CFR 3285.701 - Electrical crossovers.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 24 Housing and Urban Development 5 2011-04-01 2011-04-01 false Electrical crossovers. 3285.701... URBAN DEVELOPMENT MODEL MANUFACTURED HOME INSTALLATION STANDARDS Electrical Systems and Equipment § 3285.701 Electrical crossovers. Multi-section homes with electrical wiring in more than one section...

  12. 24 CFR 3285.701 - Electrical crossovers.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... URBAN DEVELOPMENT MODEL MANUFACTURED HOME INSTALLATION STANDARDS Electrical Systems and Equipment § 3285.701 Electrical crossovers. Multi-section homes with electrical wiring in more than one section require... 24 Housing and Urban Development 5 2013-04-01 2013-04-01 false Electrical crossovers....

  13. 24 CFR 3285.701 - Electrical crossovers.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... URBAN DEVELOPMENT MODEL MANUFACTURED HOME INSTALLATION STANDARDS Electrical Systems and Equipment § 3285.701 Electrical crossovers. Multi-section homes with electrical wiring in more than one section require... 24 Housing and Urban Development 5 2014-04-01 2014-04-01 false Electrical crossovers....

  14. 24 CFR 3285.701 - Electrical crossovers.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... URBAN DEVELOPMENT MODEL MANUFACTURED HOME INSTALLATION STANDARDS Electrical Systems and Equipment § 3285.701 Electrical crossovers. Multi-section homes with electrical wiring in more than one section require... 24 Housing and Urban Development 5 2012-04-01 2012-04-01 false Electrical crossovers....

  15. Multifunctional materials exhibiting spin crossover and liquid-crystalline properties

    NASA Astrophysics Data System (ADS)

    Seredyuk, M.; Gaspar, Ana B.; Ksenofontov, V.; Reiman, S.; Galyametdinov, Y.; Haase, W.; Rentschler, E.; Gütlich, P.

    2005-11-01

    The physical characterization of a new class of Fe(II) multifunctional SCO materials exhibiting spin crossover and liquid crystalline properties in the room temperatures region is reported. Mössbauer spectroscopy, magnetic, differential scanning calorimetry (DSC), X-ray powder diffraction (XRD) and optical polarizing microscopy studies have been performed on such materials.

  16. Comparing the weathering patterns of six oils using 3-way generalized Procrustes rotation and matrix-augmentation principal components.

    PubMed

    Fernández-Varela, R; Andrade, J M; Muniategui, S; Prada, D

    2010-12-17

    A case study is presented in which advanced chemical fingerprinting and data interpretation techniques are used to characterize and compare the weathering processes of six oil spillages made under controlled conditions (including the heavy oil released after the Prestige tanker sunk off the Galician coast-NW Spain on 2002). A tiered analytical approach using gas chromatography-flame ionization detection (GC-FID) and gas chromatography-mass spectrometry (GC-MS) was applied along with two different approaches for 3-way analyses; namely, generalized Procrustes rotation, and matrix-augmented principal components analysis. Results showed that the two 3-way chemometric techniques leaded to essentially the same conclusions when analyzing three sets of compounds fingerprinting the spilled hydrocarbons (aliphatic hydrocarbons, polycyclic aromatic hydrocarbons (PAHs) and a set of diagnostic ratios). A steady evolution on the weathering of the oils was observed with both techniques, but for the diagnostic ratios. The variables involved on the weathering were the lightest aliphatic hydrocarbons and a general combination of the PAHs, which differentiated mostly among the light and the heavy products (fuel oils).

  17. Effect of Pregabalin on Cardiovascular Responses to Exercise and Postexercise Pain and Fatigue in Fibromyalgia: A Randomized, Double-Blind, Crossover Pilot Study

    PubMed Central

    White, Andrea T.; Light, Kathleen C.; Bateman, Lucinda; Hughen, Ronald W.; Vanhaitsma, Timothy A.; Light, Alan R.

    2015-01-01

    Pregabalin, an approved treatment for fibromyalgia (FM), has been shown to decrease sympathetic nervous system (SNS) activity and inhibit sympathetically maintained pain, but its effects on exercise responses have not been reported. Methods. Using a randomized double-blind crossover design, we assessed the effect of 5 weeks of pregabalin (versus placebo) on acute cardiovascular and subjective responses to moderate exercise in 19 FM patients. Blood pressure (BP), heart rate (HR), and ratings of perceived exertion (RPE) during exercise and ratings of pain, physical fatigue, and mental fatigue before, during, and for 48 hours after exercise were compared in patients on pregabalin versus placebo and also versus 18 healthy controls. Results. On placebo, exercise RPE and BP were significantly higher in FM patients than controls (p < 0.04). Pregabalin responders (n = 12, defined by patient satisfaction and symptom changes) had significantly lower exercise BP, HR, and RPE on pregabalin versus placebo (p < 0.03) and no longer differed from controls (p > 0.26). Cardiovascular responses of nonresponders (n = 7) were not altered by pregabalin. In responders, pregabalin improved ratings of fatigue and pain (p < 0.04), but negative effects on pain and fatigue were seen in nonresponders. Conclusions. These preliminary findings suggest that pregabalin may normalize cardiovascular and subjective responses to exercise in many FM patients. PMID:27026828

  18. Rupatadine does not potentiate the CNS depressant effects of lorazepam: randomized, double-blind, crossover, repeated dose, placebo-controlled study

    PubMed Central

    García-Gea, Consuelo; Ballester, Maria Rosa; Martínez, Juan; Antonijoan, Rosa Maria; Donado, Esther; Izquierdo, Iñaki; Barbanoj, Manuel-José

    2010-01-01

    AIM The main objective was to assess whether benzodiazepine intake when rupatadine plasma concentrations were at steady-state would increase the CNS depressant effects. Rupatadine is a new H1-antihistamine which also inhibits platelet activating factor (PAF) release and has been shown to be clinically effective at doses of 10 mg. METHODS Sixteen healthy young volunteers took part in a crossover, randomized, double-blind, placebo controlled trial comprising two experimental periods (repeated administration for 7 days of rupatadine 10 mg or placebo as single oral daily doses, separated by a washout of 14 days). On days 5 and 7, according to a fully balanced design, a single oral dose of lorazepam 2 mg or placebo was added. CNS effects were evaluated on these days by seven objective tests of psychomotor performance and eight subjective visual analogue scales (VAS) at pre-dose and several times after drug intake. Four treatment conditions were evaluated: placebo, rupatadine 10 mg, lorazepam 2 mg and rupatadine 10 mg + lorazepam 2 mg. RESULTS Significant CNS effects, either impairment of psychomotor performance or subjective sedation, were observed when lorazepam was administered, either alone or in combination with steady state concentrations of rupatadine. No significant differences were found between these two conditions. In addition, rupatadine was not different from placebo. All treatments were well tolerated. CONCLUSION Repeated doses of rupatadine (10 mg orally) did not enhance the CNS depressant effects of lorazepam (2 mg orally, single dose) either in objective psychomotor tasks or in subjective evaluations. PMID:20565458

  19. Neutrino dynamics below the electroweak crossover

    NASA Astrophysics Data System (ADS)

    Ghiglieri, J.; Laine, M.

    2016-07-01

    We estimate the thermal masses and damping rates of active (m < eV) and sterile (M ~ GeV) neutrinos with thermal momenta k~ 3T at temperatures below the electroweak crossover (5 GeV < T < 160 GeV) . These quantities fix the equilibration or ``washout'' rates of Standard Model lepton number densities. Sterile neutrinos interact via direct scatterings mediated by Yukawa couplings, and via their overlap with active neutrinos. Including all leading-order reactions we find that the washout rate generally exceeds the Hubble rate for 5 GeV < T < 30 GeV . Therefore it is challenging to generate a large lepton asymmetry facilitating dark matter computations operating at T < 5 GeV, whereas the generation of a baryon asymmetry at T > 130 GeV remains an option. Our differential rates are tabulated in a form suitable for studies of specific scenarios with given neutrino Yukawa matrices.

  20. High-Resolution Mapping of Crossover and Non-crossover Recombination Events by Whole-Genome Re-sequencing of an Avian Pedigree

    PubMed Central

    Qvarnström, Anna; Ellegren, Hans

    2016-01-01

    Recombination is an engine of genetic diversity and therefore constitutes a key process in evolutionary biology and genetics. While the outcome of crossover recombination can readily be detected as shuffled alleles by following the inheritance of markers in pedigreed families, the more precise location of both crossover and non-crossover recombination events has been difficult to pinpoint. As a consequence, we lack a detailed portrait of the recombination landscape for most organisms and knowledge on how this landscape impacts on sequence evolution at a local scale. To localize recombination events with high resolution in an avian system, we performed whole-genome re-sequencing at high coverage of a complete three-generation collared flycatcher pedigree. We identified 325 crossovers at a median resolution of 1.4 kb, with 86% of the events localized to <10 kb intervals. Observed crossover rates were in excellent agreement with data from linkage mapping, were 52% higher in male (3.56 cM/Mb) than in female meiosis (2.28 cM/Mb), and increased towards chromosome ends in male but not female meiosis. Crossover events were non-randomly distributed in the genome with several distinct hot-spots and a concentration to genic regions, with the highest density in promoters and CpG islands. We further identified 267 non-crossovers, whose location was significantly associated with crossover locations. We detected a significant transmission bias (0.18) in favour of ‘strong’ (G, C) over ‘weak’ (A, T) alleles at non-crossover events, providing direct evidence for the process of GC-biased gene conversion in an avian system. The approach taken in this study should be applicable to any species and would thereby help to provide a more comprehensive portray of the recombination landscape across organism groups. PMID:27219623

  1. Ambient Particulate Matter (PM2.5/PM10) Exposure and Emergency Department Visits for Acute Myocardial Infarction in Chaoyang District, Beijing, China During 2014: A Case-Crossover Study

    PubMed Central

    Zhang, Qian; Qi, Weipeng; Yao, Wei; Wang, Mei; Chen, Yiyong; Zhou, Yujie

    2016-01-01

    Background Epidemiology studies have shown a consistently increased risk of acute myocardial infarction (AMI) correlated with particulate matter (PM) exposure. However, little is known about the association with specific AMI subtypes. In this work, we investigated the association between short-term PM exposure and emergency department visits (EDVs) for AMI, ST-elevation myocardial infarction (STEMI), and non-ST-elevation myocardial infarction (NSTEMI). Methods We based this case-crossover study on 2749 patients from Chaoyang District hospitalized with AMI in Anzhen Hospital during 2014. Meteorological and air pollution data were collected during this period. We used a time-stratified case-crossover design with lag model, adjusted for meteorological conditions and/or other gaseous pollutants, to estimate risk of EDVs for AMI, STEMI, and NSTEMI. We conducted stratified analyses by gender, age, season, and comorbid conditions to examine potential effect modification. Results We found that each 10 µg/m3 increment of PM2.5 concentration (1-day lagged) was associated with an increased risk of EDVs for STEMI (OR 1.05; 95% CI, 1.00–1.11). We found no association of PM2.5 concentration with overall AMI or NSTEMI. No effect modification was found when stratified by gender, season, or comorbid conditions, even though the effect size was larger in patients who were male, smokers, and comorbid with hypertension. Patients aged ≥65 years showed a significantly increased risk of STEMI associated with PM2.5 in the previous day than those aged <65 years. Conclusions Our study indicated a transient effect of short-term PM2.5 exposure on EDVs for STEMI. Patients aged ≥65 years appeared to be particularly susceptible. Our findings suggest that studies of the association between PM exposure and AMI should consider AMI subtypes, lag times, and individual characteristics. PMID:27064131

  2. Vulnerability to heat-related mortality in Latin America: a case-crossover study in São Paulo, Brazil, Santiago, Chile and Mexico City, Mexico

    PubMed Central

    Bell, Michelle L; O’Neill, Marie S; Ranjit, Nalini; Borja-Aburto, Victor H; Cifuentes, Luis A; Gouveia, Nelson C

    2008-01-01

    Background Factors affecting vulnerability to heat-related mortality are not well understood. Identifying susceptible populations is of particular importance given anticipated rising temperatures from climatic change. Methods We investigated heat-related mortality for three Latin American cities (Mexico City, Mexico; São Paulo, Brazil; Santiago, Chile) using a case-crossover approach for 754 291 deaths from 1998 to 2002. We considered lagged exposures, confounding by air pollution, cause of death and susceptibilities by educational attainment, age and sex. Results Same and previous day apparent temperature were most strongly associated with mortality risk. Effect estimates remained positive though lowered after adjustment for ozone or PM10. Susceptibility increased with age in all cities. The increase in mortality risk for those ≥65 comparing the 95th and 75th percentiles of same-day apparent temperature was 2.69% (95% CI: −2.06 to 7.88%) for Santiago, 6.51% (95% CI: 3.57–9.52%) for São Paulo and 3.22% (95% CI: 0.93–5.57%) for Mexico City. Patterns of vulnerability by education and sex differed across communities. Effect estimates were higher for women than men in Mexico City, and higher for men elsewhere, although results by sex were not appreciably different for any city. In São Paulo, those with less education were more susceptible, whereas no distinct patterns by education were observed in the other cities. Conclusions Elevated temperatures are associated with mortality risk in these Latin American cities, with the strongest associations in São Paulo, the hottest city. The elderly are an important population for targeted prevention measures, but vulnerability by sex and education differed by city. PMID:18511489

  3. Crossover from the parity-conserving pair contact process with diffusion to other universality classes

    NASA Astrophysics Data System (ADS)

    Park, Su-Chan; Park, Hyunggyu

    2009-05-01

    The pair contact process with diffusion (PCPD) with modulo 2 conservation (PCPD2) [ 2A→4A , 2A→0 ] is studied in one dimension, focused on the crossover to other well established universality classes: the directed Ising (DI) and the directed percolation (DP). First, we show that the PCPD2 shares the critical behaviors with the PCPD, both with and without directional bias. Second, the crossover from the PCPD2 to the DI is studied by including a parity-conserving single-particle process (A→3A) . We find the crossover exponent 1/ϕ1=0.57(3) , which is argued to be identical to that of the PCPD-to-DP crossover by adding A→2A . This suggests that the PCPD universality class has a well-defined fixed point distinct from the DP. Third, we study the crossover from a hybrid-type reaction-diffusion process belonging to the DP [ 3A→5A , 2A→0 ] to the DI by adding A→3A . We find 1/ϕ2=0.73(4) for the DP-to-DI crossover. The inequality of ϕ1 and ϕ2 further supports the non-DP nature of the PCPD scaling. Finally, we introduce a symmetry-breaking field in the dual spin language to study the crossover from the PCPD2 to the DP. We find 1/ϕ3=1.23(10) , which is associated with a new independent route from the PCPD to the DP.

  4. Topoisomerase II Mediates Meiotic Crossover Interference

    PubMed Central

    Zhang, Liangran; Wang, Shunxin; Yin, Shen; Hong, Soogil; Kim, Keun P.; Kleckner, Nancy

    2014-01-01

    Summary Spatial patterning is a ubiquitous feature of biological systems. Meiotic crossovers provide an interesting example, defined by the classical phenomenon of crossover interference. Here, analysis of crossover patterns in budding yeast identifies a molecular pathway for interference. Topoisomerase II (Topo II) plays a central role, thus identifying a new function for this critical molecule. SUMOylation [of TopoII and axis component Red1] and ubiquitin-mediated removal of SUMOylated proteins are also required. These and other findings support the hypothesis that crossover interference involves accumulation, relief and redistribution of mechanical stress along the protein/DNA meshwork of meiotic chromosome axes, with TopoII required to adjust spatial relationships among DNA segments. PMID:25043020

  5. Heat training increases exercise capacity in hot but not in temperate conditions: a mechanistic counter-balanced cross-over study.

    PubMed

    Keiser, Stefanie; Flück, Daniela; Hüppin, Fabienne; Stravs, Alexander; Hilty, Matthias P; Lundby, Carsten

    2015-09-01

    The aim was to determine the mechanisms facilitating exercise performance in hot conditions following heat training. In a counter-balanced order, seven males (V̇o2max 61.2 ± 4.4 ml·min(-1)·kg(-1)) were assigned to either 10 days of 90-min exercise training in 18 or 38°C ambient temperature (30% relative humidity) applying a cross-over design. Participants were tested for V̇o2max and 30-min time trial performance in 18 (T18) and 38°C (T38) before and after training. Blood volume parameters, sweat output, cardiac output (Q̇), cerebral perfusion (i.e., middle cerebral artery velocity [MCAvmean]), and other variables were determined. Before one set of exercise tests in T38, blood volume was acutely expanded by 538 ± 16 ml with an albumin solution (T38A) to determine the role of acclimatization induced hypervolemia on exercise performance. We furthermore hypothesized that heat training would restore MCAvmean and thereby limit centrally mediated fatigue. V̇o2max and time trial performance were equally reduced in T38 and T38A (7.2 ± 1.6 and 9.3 ± 2.5% for V̇o2max; 12.8 ± 2.8 and 12.9 ± 2.8% for time trial). Following heat training both were increased in T38 (9.6 ± 2.1 and 10.4 ± 3.1%, respectively), whereas both V̇o2max and time trial performance remained unchanged in T18. As expected, heat training augmented plasma volume (6 ± 2%) and mean sweat output (26 ± 6%), whereas sweat [Na(+)] became reduced by 19 ± 7%. In T38 Q̇max remained unchanged before (21.3 ± 0.6 l/min) to after (21.7 ± 0.5 l/min) training, whereas MCAvmean was increased by 13 ± 10%. However, none of the observed adaptations correlated with the concomitant observed changes in exercise performance.

  6. Skating crossovers on a motorized flywheel: a preliminary experimental design to test effect on speed and on crossovers.

    PubMed

    Smith, Aynsley M; Krause, David A; Stuart, Michael J; Montelpare, William J; Sorenson, Matthew C; Link, Andrew A; Gaz, Daniel V; Twardowski, Casey P; Larson, Dirk R; Stuart, Michael B

    2013-12-01

    Ice hockey requires frequent skater crossovers to execute turns. Our investigation aimed to determine the effectiveness of training crossovers on a motorized, polyethylene high-resistance flywheel. We hypothesized that high school hockey players training on the flywheel would perform as well as their peers training on ice. Participants were 23 male high-school hockey players (age 15-19 years). The study used an experimental prospective design to compare players who trained for 9 sessions on the 22-foot flywheel with players who trained for 9 sessions on a similarly sized on-ice circle. Both groups were compared with control subjects who were randomly selected from the same participant pool as those training on ice. All players were tested before and after their 3-week training regimens, and control subjects were asked to not practice crossovers between testing. Group 1 trained in a hockey training facility housing the flywheel, and group 2 trained in the ice hockey arena where testing occurred. Primary outcome measures tested in both directions were: (a) speed (time in seconds) required to skate crossovers for 3 laps of a marked face-off circle, (b) cadence of skating crossovers on the similarly sized circles, and (c) a repeat interval speed test, which measures anaerobic power. No significant changes were found between groups in on-ice testing before and after training. Among the group 1 players, 7 of 8 believed they benefited from flywheel training. Group 2 players, who trained on ice, did not improve performance significantly over group 1 players. Despite the fact that no significant on-ice changes in performance were observed in objective measures, players who trained on the flywheel subjectively reported that the flywheel is an effective cost-effective alternative to training on ice. This is a relevant finding when placed in context with limited availability of on-ice training. PMID:23539081

  7. A healthy diet with and without cereal grains and dairy products in patients with type 2 diabetes: study protocol for a random-order cross-over pilot study - Alimentation and Diabetes in Lanzarote -ADILAN

    PubMed Central

    2014-01-01

    Background Research on the role of nutrition in type 2 diabetes has largely focused on macro/micronutrient composition and dietary fiber intake, while fewer studies have tested the effects of differing food choice. Some observational studies and short-term intervention studies suggest that a food pattern mimicking the diet with which humans evolved positively influences glucose control and associated endocrine systems. Such a food pattern mainly differs from other common healthy food patterns in its absence of cereal grains and dairy products. The primary aim of this pilot study is to determine the effect of two healthy diets with or without cereal grains and dairy products on glucose control, while keeping participants’ weight stable and other food parameters, such as macro/micronutrient composition, dietary fiber and glycemic load, the same in both diets. Methods/Design We intend to include 15 adult patients with a medical diagnosis of type 2 diabetes mellitus with or without medication and with an increased waist circumference (≥ 80 cm for women and ≥ 94 cm for men) in a random-order cross-over diet intervention study during two periods of four-weeks separated by a six-week washout period. Patients will be instructed to eat two healthy diets according to official dietary guidelines with respect to macro/micronutrient composition and fiber content, but differing in the type of food included, with one diet being without cereal grains and dairy products. Lunch will be served in a hospital kitchen for control of nutrient intake, while the rest of the meals will be eaten at home according to specific directions. The energy content of the diets will be individually adjusted to maintain a stable body weight during the two four-week intervention periods. Primary outcomes will be change in fasting plasma glucagon and fructosamine, while secondary outcomes include change in fasting glucose and glycated hemoglobin, glucose and glucagon response during oral

  8. Crossover behavior in hydrogen sensing mechanism for palladium ultrathin films.

    SciTech Connect

    Darling, S. B.; Ramanathan, M.; Skudlarek, G.; Wang, H. H.; Illinois Math and Science Academy

    2010-01-01

    Palladium has been extensively studied as a material for hydrogen sensors because of the simplicity of its reversible resistance change when exposed to hydrogen gas. Various palladium films and nanostructures have been used, and different responses have been observed with these diverse morphologies. In some cases, such as with nanowires, the resistance will decrease, whereas in others, such as with thick films, the resistance will increase. Each of these mechanisms has been explored for several palladium structures, but the crossover between them has not been systematically investigated. Here we report on a study aimed at deciphering the nanostructure-property relationships of ultrathin palladium films used as hydrogen gas sensors. The crossover in these films is observed at a thickness of {approx} 5 nm. Ramifications for future sensor developments are discussed.

  9. Intrinsic DNA curvature of double-crossover tiles

    NASA Astrophysics Data System (ADS)

    Kim, Seungjae; Kim, Junghoon; Qian, Pengfei; Shin, Jihoon; Amin, Rashid; Ahn, Sang Jung; LaBean, Thomas H.; Kim, Moon Ki; Park, Sung Ha

    2011-06-01

    A theoretical model which takes into account the structural distortion of double-crossover DNA tiles has been studied to investigate its effect on lattice formation sizes. It has been found that a single vector appropriately describes the curvature of the tiles, of which a higher magnitude hinders lattice growth. In conjunction with these calculations, normal mode analysis reveals that tiles with relative higher frequencies have an analogous effect. All the theoretical results are shown to be in good agreement with experimental data.

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

    PubMed Central

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

    2015-01-01

    Purpose Diuretics are the primary treatment for the management of chronic heart failure (HF) symptoms and for the improvement of acute HF symptoms. The rate of delivery to the site of action has been suggested to affect diuretic pharmacodynamics. The main objective of this clinical trial was to explore whether a prolonged release tablet formulation of torasemide (torasemide-PR) was more natriuretically efficient in patients with chronic HF compared to immediate-release furosemide (furosemide-IR) after a single-dose administration. Moreover, the pharmacokinetics of torasemide-PR, furosemide-IR, and torasemide-IR were assessed in chronic HF patients as well as urine pharmacodynamics. Methods Randomized, open-label, blinded-endpoint, crossover, and single-dose Phase I clinical trial with three experimental periods. Torasemide-PR and furosemide-IR were administered as a single dose in a crossover fashion for the first two periods, and torasemide-IR 10 mg was administered for the third period. Blood and urine samples were collected at fixed timepoints. The primary endpoint was the natriuretic efficiency after administration of torasemide-PR and furosemide-IR, defined as the ratio between the average drug-induced natriuresis and the average drug recovered in urine over 24 hours. Results Ten patients were included and nine completed the study. Here, we present the results from nine patients. Torasemide-PR was more natriuretically efficient than furosemide-IR (0.096±0.03 mmol/μg vs 0.015±0.0007 mmol/μg; P<0.0001). Mictional urgency was lower and more delayed with torasemide-PR than with furosemide-IR. Conclusion In a study with a limited sample size, our results suggest that 10 mg of torasemide-PR is more natriuretically efficient than 40 mg of furosemide-IR after single-dose administration in patients with chronic HF over a 24-hour collection period. Further studies are necessary to evaluate potential pharmacodynamic differences between torasemide formulations and to

  11. Nocturnal antihypertensive treatment in patients with type 1 diabetes with autonomic neuropathy and non-dipping of blood pressure during night time: protocol for a randomised, placebo-controlled, double-blind, two-way crossover study

    PubMed Central

    Hjortkær, Henrik; Jensen, Tonny; Kofoed, Klaus; Mogensen, Ulrik; Køber, Lars; Hilsted, Karen Lisa; Corinth, Helle; Theilade, Simone; Hilsted, Jannik

    2014-01-01

    Introduction Cardiac autonomic neuropathy (CAN) and elevated nocturnal blood pressure are independent risk factors for cardiovascular disease in patients with diabetes. Previously, associations between CAN, non-dipping of nocturnal blood pressure and coronary artery calcification have been demonstrated. The present protocol describes a trial to test the efficacy of bedtime dosing of the ACE inhibitor enalapril on night time blood pressure and left ventricular mass in patients with type 1 diabetes. Materials and methods In a randomised, double-blind, two-way cross-over study, 24 normoalbuminuric patients with type 1 diabetes with CAN will be treated for 12 weeks with either morning or bedtime dosing of 20 mg enalapril, followed by 12 weeks of switched treatment regimen. During each treatment period, two 24 h ambulatory blood pressure measurements will be performed and after each treatment period left ventricular mass will be determined by multisliced CT. Primary end points will be reduction in blood pressure and reduction in left ventricular mass. Ethics and dissemination The study has been approved by the Danish Medicines Agency, the Scientific-Ethical Committee of the Capital Region of Denmark and the Danish Data Protection Agency. An external monitoring committee (the Good Clinical Practice Unit at Copenhagen University Hospital) will oversee the study. The results of the study will be presented at national and international scientific meetings and publications will be submitted to peer-reviewed journals. Trial registration number EudraCT (2012- 002136-90). PMID:25293387

  12. A double-blind, placebo-controlled, cross-over study to establish the bifidogenic effect of a very-long-chain inulin extracted from globe artichoke (Cynara scolymus) in healthy human subjects.

    PubMed

    Costabile, Adele; Kolida, Sofia; Klinder, Annett; Gietl, Eva; Bäuerlein, Michael; Frohberg, Claus; Landschütze, Volker; Gibson, Glenn R

    2010-10-01

    There is growing interest in the use of inulins as substrates for the selective growth of beneficial gut bacteria such as bifidobacteria and lactobacilli because recent studies have established that their prebiotic effect is linked to several health benefits. In the present study, the impact of a very-long-chain inulin (VLCI), derived from globe artichoke (Cynara scolymus), on the human intestinal microbiota compared with maltodextrin was determined. A double-blind, cross-over study was carried out in thirty-two healthy adults who were randomised into two groups and consumed 10 g/d of either VLCI or maltodextrin, for two 3-week study periods, separated by a 3-week washout period. Numbers of faecal bifidobacteria and lactobacilli were significantly higher upon VLCI ingestion compared with the placebo. Additionally, levels of Atopobium group significantly increased, while Bacteroides-Prevotella numbers were significantly reduced. No significant changes in faecal SCFA concentrations were observed. There were no adverse gastrointestinal symptoms apart from a significant increase in mild and moderate bloating upon VLCI ingestion. These observations were also confirmed by in vitro gas production measurements. In conclusion, daily consumption of VLCI extracted from globe artichoke exerted a pronounced prebiotic effect on the human faecal microbiota composition and was well tolerated by all volunteers.

  13. An acute, double-blind, placebo-controlled crossover study of 320 mg and 640 mg doses of a special extract of Bacopa monnieri (CDRI 08) on sustained cognitive performance.

    PubMed

    Downey, Luke A; Kean, James; Nemeh, Fiona; Lau, Angela; Poll, Alex; Gregory, Rebecca; Murray, Margaret; Rourke, Johanna; Patak, Brigit; Pase, Matthew P; Zangara, Andrea; Lomas, Justine; Scholey, Andrew; Stough, Con

    2013-09-01

    Standardized extracts of the traditional Ayurvedic medicine Bacopa monnieri (BM) (Brahmi) have been recently shown to have cognitive enhancing effects in chronic administration studies. Pre-clinical work has also identified a number of acute anxiolytic, nootropic, and cardiovascular effects of BM. There has, however, been little research on the acute effects of BM on cognitive function. The current study aimed to assess the acute effects of a specific extract of BM (KeenMind®-CDRI 08) in a double-blind, placebo-controlled study in normal healthy participants who completed a cognitively demanding series of tests. Twenty-four healthy volunteers completed six repetitions of the Cognitive Demand Battery (CDB) after consuming a placebo, 320 mg BM or 640 mg of BM in a cross-over design and provided cardiovascular and mood assessments before and after treatment. Change from baseline scores indicated that the 320 mg dose of BM improved performance at the first, second, and fourth repetition post-dosing on the CDB, and the treatments had no effect upon cardiovascular activity or in attenuating task-induced ratings of stress and fatigue. It was concluded that assessment of an earlier pharmacological window and use of less memory-specific cognitive tests together with more temporally sensitive measures of brain activity may improve our understanding of the acute neurocognitive properties of BM.

  14. An acute, double-blind, placebo-controlled crossover study of 320 mg and 640 mg doses of a special extract of Bacopa monnieri (CDRI 08) on sustained cognitive performance.

    PubMed

    Downey, Luke A; Kean, James; Nemeh, Fiona; Lau, Angela; Poll, Alex; Gregory, Rebecca; Murray, Margaret; Rourke, Johanna; Patak, Brigit; Pase, Matthew P; Zangara, Andrea; Lomas, Justine; Scholey, Andrew; Stough, Con

    2013-09-01

    Standardized extracts of the traditional Ayurvedic medicine Bacopa monnieri (BM) (Brahmi) have been recently shown to have cognitive enhancing effects in chronic administration studies. Pre-clinical work has also identified a number of acute anxiolytic, nootropic, and cardiovascular effects of BM. There has, however, been little research on the acute effects of BM on cognitive function. The current study aimed to assess the acute effects of a specific extract of BM (KeenMind®-CDRI 08) in a double-blind, placebo-controlled study in normal healthy participants who completed a cognitively demanding series of tests. Twenty-four healthy volunteers completed six repetitions of the Cognitive Demand Battery (CDB) after consuming a placebo, 320 mg BM or 640 mg of BM in a cross-over design and provided cardiovascular and mood assessments before and after treatment. Change from baseline scores indicated that the 320 mg dose of BM improved performance at the first, second, and fourth repetition post-dosing on the CDB, and the treatments had no effect upon cardiovascular activity or in attenuating task-induced ratings of stress and fatigue. It was concluded that assessment of an earlier pharmacological window and use of less memory-specific cognitive tests together with more temporally sensitive measures of brain activity may improve our understanding of the acute neurocognitive properties of BM. PMID:23281132

  15. A randomised, double-blind, placebo-controlled, crossover study to assess the efficacy and safety of three dosing schedules of agalsidase alfa enzyme replacement therapy for Fabry disease.

    PubMed

    Hughes, D A; Deegan, P B; Milligan, A; Wright, N; Butler, L H; Jacobs, A; Mehta, A B

    2013-07-01

    Anecdotal reports suggest that the currently approved dosing interval of agalsidase alfa (0.2 mg/kg/2 weeks) for Fabry disease treatment is too long. This randomised, double-blind, placebo-controlled, crossover study investigated three altered dosing intervals. 18 Fabry patients received three agalsidase alfa dosing schedules, each for four weeks (A: 0.2 mg/kg∗2 weeks, B: 0.1 mg/kg/week, C: 0.2 mg/kg/week). Health state, pain levels, sweat volume and latency and plasma and urinary globotriaosylceramide levels were recorded throughout the study. No significant differences were found among the schedules for the primary efficacy outcome of self-assessed health state, or for pain scores. A trend toward increased sweat volume on QSART testing, and reduced urine globotriaosylceramide concentration were seen with treatment schedule C. Agalsidase alfa was safe and well tolerated with all schedules. In conclusion, the primary analyses did not find weekly infusions of agalsidase alfa to be statistically better than the approved dosing schedule however the data indicates that further studies with more patients over a longer period are required to more accurately determine the optimum dose and schedule. PMID:23702393

  16. Evaluation of the Immediate Effect of Auricular Acupuncture on Pain and Electromyographic Activity of the Upper Trapezius Muscle in Patients with Nonspecific Neck Pain: A Randomized, Single-Blinded, Sham-Controlled, Crossover Study

    PubMed Central

    Silva, Andréia Cristina de Oliveira; Biasotto-Gonzalez, Daniela Aparecida; dos Santos, Douglas Meira; Melo, Nivea Cristina De; Gomes, Cid André Fidelis de Paula; Amorim, César Ferreira; Politti, Fabiano

    2015-01-01

    Background. The aim of the present study was to assess the immediate effects of auricular acupuncture (AA) on the electromyographic (EMG) activity of the upper trapezius muscle and pain in nonspecific neck pain (NS-NP) patients. Twelve patients with NS-NP (NS-NP group) and 12 healthy subjects (HS Group) were enrolled in a randomized, single-blinded, crossover study. Each subject received a single session of AA and sham AA (SAA). Surface EMG activity was measured in the upper trapezius muscle at different “step contractions” of isometric shoulder elevation (15%, 20%, 25%, and 30% MVC). The outcome measure in patients with NS-NP was based on the numerical pain rating scale (NRS). AA treatment led to a significant decrease in EMG activity in both groups (NS-NP group: p = 0.0001; HS group: p < 0.0001—ANOVA test). This was not the case for the SAA treatment (NS-NP group: p = 0.71; HS group: p < 0.54). Significant decreases (p < 0.001) in the NRS were found for both treatments (AA and SAA). This study demonstrated the immediate effect of auricular acupuncture on the electromyographic activity of the upper trapezius muscle but the effect of this intervention on pain symptoms in patients with nonspecific neck pain was inconclusive. PMID:26451155

  17. Evaluation of the Immediate Effect of Auricular Acupuncture on Pain and Electromyographic Activity of the Upper Trapezius Muscle in Patients with Nonspecific Neck Pain: A Randomized, Single-Blinded, Sham-Controlled, Crossover Study.

    PubMed

    Silva, Andréia Cristina de Oliveira; Biasotto-Gonzalez, Daniela Aparecida; Dos Santos, Douglas Meira; Melo, Nivea Cristina De; Gomes, Cid André Fidelis de Paula; Amorim, César Ferreira; Politti, Fabiano

    2015-01-01

    Background. The aim of the present study was to assess the immediate effects of auricular acupuncture (AA) on the electromyographic (EMG) activity of the upper trapezius muscle and pain in nonspecific neck pain (NS-NP) patients. Twelve patients with NS-NP (NS-NP group) and 12 healthy subjects (HS Group) were enrolled in a randomized, single-blinded, crossover study. Each subject received a single session of AA and sham AA (SAA). Surface EMG activity was measured in the upper trapezius muscle at different "step contractions" of isometric shoulder elevation (15%, 20%, 25%, and 30% MVC). The outcome measure in patients with NS-NP was based on the numerical pain rating scale (NRS). AA treatment led to a significant decrease in EMG activity in both groups (NS-NP group: p = 0.0001; HS group: p < 0.0001-ANOVA test). This was not the case for the SAA treatment (NS-NP group: p = 0.71; HS group: p < 0.54). Significant decreases (p < 0.001) in the NRS were found for both treatments (AA and SAA). This study demonstrated the immediate effect of auricular acupuncture on the electromyographic activity of the upper trapezius muscle but the effect of this intervention on pain symptoms in patients with nonspecific neck pain was inconclusive.

  18. Isospin Dependent Pairing Interactions and BCS-BEC crossover

    SciTech Connect

    Sagawa, H.; Margueron, J.; Hagino, K.

    2008-11-11

    We propose new types of density dependent contact pairing interaction which reproduce the pairing gaps in symmetric and neutron matters obtained by a microscopic treatment based on the realistic nucleon-nucleon interaction. The BCS-BEC crossover of neutrons pairs in symmetric and asymmetric nuclear matters is studied by using these contact interactions. It is shown that the bare and screened pairing interactions lead to different features of the BCS-BEC crossover in symmetric nuclear matter. We perform Hartree-Fock-Bogoliubov (HFB) calculations for semi-magic Calcium, Nickel, Tin and Lead isotopes and N = 20, 28, 50 and 82 isotones using these density-dependent pairing interactions. Our calculations well account for the experimental data for the neutron number dependence of binding energy, two neutrons separation energy, and odd-even mass staggering of these isotopes. Especially the interaction IS+IV Bare without the medium polarization effect gives satisfactory results for all the isotopes.

  19. An evaluation of the cognitive and mood effects of an energy shot over a 6h period in volunteers: a randomized, double-blind, placebo controlled, cross-over study.

    PubMed

    Wesnes, Keith A; Barrett, Marilyn L; Udani, Jay K

    2013-08-01

    Energy drinks are widely available mostly containing glucose, and several have been demonstrated to improve alertness and cognitive function; these effects generally being identified 30-60min after administration. The present study assessed whether an energy shot without carbohydrates would affect major aspects of cognitive function and also mood in volunteers over a 6h time period. This randomized, double-blind, placebo-controlled,crossover study compared the acute effects of the energy shot with a matching placebo in 94 healthy volunteers. Cognitive function was assessed with a widely used set of automated tests of attention and memory. Mood was assessed with the Bond-Lader, Beck Anxiety Index, Beck Depression Index, Chalder Fatigue Scales (CFS), and the POMS. The volunteers were requested to limit their sleep to between 3 and 6h the night before each testing day. Compared to the placebo, the energy shot significantly improved 6 validated composite cognitive function measures from the CDR System as well as self-rated alertness; the benefits on 4 of the cognitive measures still remaining at 6h. The overall effect sizes of the performance improvements were in the small to medium range and thus notable in this field. In conclusion, an energy shot can significantly improve important aspects of cognitive function for up to 6h compared to placebo in partially sleep-deprived healthy volunteers.

  20. Consumption of low-fat dairy foods for 6 months improves insulin resistance without adversely affecting lipids or bodyweight in healthy adults: a randomized free-living cross-over study

    PubMed Central

    2013-01-01

    Background Given the highly debated role of dairy food consumption in modulating biomarkers of metabolic syndrome, this study was conducted to examine the influence of long-term (6 month) dairy consumption on metabolic parameters in healthy volunteers under free-living conditions without energy restriction. Methods Twenty-three healthy subjects completed a randomized, crossover trial of 12 months. Participants consumed their habitual diets and were randomly assigned to one of two treatment groups: a high dairy supplemented group instructed to consume 4 servings of dairy per day (HD); or a low dairy supplemented group limited to no more than 2 servings of dairy per day (LD). Baseline, midpoint, and endpoint metabolic responses were examined. Results Endpoint measurements of body weight and composition, energy expenditure, blood pressure, blood glucose, and blood lipid and lipoprotein responses did not differ (p > 0.05) between the LD and HD groups. HD consumption improved (p < 0.05) plasma insulin (-9%) and insulin resistance (-11%, p = 0.03) as estimated by HOMA-IR compared with the LD group. Conclusions Study results suggest that high dairy consumption (4 servings/d) may improve insulin resistance without negatively impacting bodyweight or lipid status under free-living conditions. Trial registration Trial registration: NCT01761955 PMID:23638799

  1. An evaluation of the cognitive and mood effects of an energy shot over a 6h period in volunteers: a randomized, double-blind, placebo controlled, cross-over study.

    PubMed

    Wesnes, Keith A; Barrett, Marilyn L; Udani, Jay K

    2013-08-01

    Energy drinks are widely available mostly containing glucose, and several have been demonstrated to improve alertness and cognitive function; these effects generally being identified 30-60min after administration. The present study assessed whether an energy shot without carbohydrates would affect major aspects of cognitive function and also mood in volunteers over a 6h time period. This randomized, double-blind, placebo-controlled,crossover study compared the acute effects of the energy shot with a matching placebo in 94 healthy volunteers. Cognitive function was assessed with a widely used set of automated tests of attention and memory. Mood was assessed with the Bond-Lader, Beck Anxiety Index, Beck Depression Index, Chalder Fatigue Scales (CFS), and the POMS. The volunteers were requested to limit their sleep to between 3 and 6h the night before each testing day. Compared to the placebo, the energy shot significantly improved 6 validated composite cognitive function measures from the CDR System as well as self-rated alertness; the benefits on 4 of the cognitive measures still remaining at 6h. The overall effect sizes of the performance improvements were in the small to medium range and thus notable in this field. In conclusion, an energy shot can significantly improve important aspects of cognitive function for up to 6h compared to placebo in partially sleep-deprived healthy volunteers. PMID:23587521

  2. Pharmacokinetic profile of rizatriptan 10-mg tablet and 10-mg orally disintegrating tablet administered with or without water in healthy subjects: an open-label, randomized, single-dose, 3-period crossover study.

    PubMed

    Swan, Suzanne K; Alcorn, Harry; Rodgers, Anthony; Hustad, Carolyn M; Ramsey, Karen E; Woll, Susan; Skobieranda, Franck

    2006-02-01

    This open-label, 3-period crossover study compared the plasma concentration profiles of rizatriptan tablet, orally disintegrating tablet with water (ODTc), and ODT without water (ODTs) in 24 healthy volunteers aged 18 to 45 years. At each period, subjects received a single dose of either 10-mg rizatriptan tablet, 10-mg rizatriptan ODTs, or 10-mg rizatriptan ODTc. The authors hypothesized that ODTc has a greater geometric mean AUC(0-2h) than ODTs and that ODTc has a greater geometric mean AUC(0-1h) than tablet. A secondary end point was to compare the time of occurrence of the maximum rizatriptan plasma concentration (t(max)) of each dosing method. ODTc had a statistically significantly greater geometric mean AUC(0-2h) compared with ODTs (33.84 h x ng/mL vs 18.83 h x ng/mL; P < .001). ODTc had a slightly, but not statistically significantly, greater geometric mean AUC(0-1h) compared with rizatriptan tablet (17.07 h x ng/mL vs 13.32 h x ng/mL). The median t(max) was 0.67 hours for ODTc and tablet and 1.33 hours for ODTs. ODTc showed a slightly, but not significantly, faster rate of absorption compared with tablet. ODTs with water had a faster rate of absorption than ODTc. Future studies are needed to determine whether this pharmacokinetic difference produces differential efficacy in a clinical setting. PMID:16432269

  3. Modelling of the PROTO-2 crossover network

    NASA Astrophysics Data System (ADS)

    Proulx, G. A.; Lackner, H.; Spence, P.; Wright, T. P.

    In order to drive a double ring, symmetrically fed bremsstrahlung diode, the PROTO II accelerator was redesigned. The radially converging triplate water line was reconfigured to drive radial converging triplate lines in parallel. The four output lines were connected to the two input lines via an electrically enclosed tubular crossover network. Low-voltage Time Domain Reflectrometry (TDR) experiments were conducted on a full scale water immersed model of one section of the crossover network as an aid in this design. A lumped element analysis of the power flow through the network was inadequate in explaining the observed wave transmission and reflection characteristics. A more detailed analysis was performed with a circuit code in which we considered both localized lump-element and transmission line features of the crossover network. Experimental results of the model tests are given and compared with the circuit simulations.

  4. Direct observation in 3d of structural crossover in binary hard sphere mixtures

    NASA Astrophysics Data System (ADS)

    Statt, Antonia; Pinchaipat, Rattachai; Turci, Francesco; Evans, Robert; Royall, C. Patrick

    2016-04-01

    For binary fluid mixtures of spherical particles in which the two species are sufficiently different in size, the dominant wavelength of oscillations of the pair correlation functions is predicted to change from roughly the diameter of the large species to that of the small species along a sharp crossover line in the phase diagram [C. Grodon et al., J. Chem. Phys. 121, 7869 (2004)]. Using particle-resolved colloid experiments in 3d we demonstrate that crossover exists and that its location in the phase diagram is in quantitative agreement with the results of both theory and our Monte-Carlo simulations. In contrast with previous work [J. Baumgartl et al., Phys. Rev. Lett. 98, 198303 (2007)], where a correspondence was drawn between crossover and percolation of both species, in our 3d study we find that structural crossover is unrelated to percolation.

  5. Relativistic BCS-BEC crossover in a boson-fermion model

    SciTech Connect

    Deng Jian; Wang Qun; Schmitt, Andreas

    2007-08-01

    We investigate the crossover from Bardeen-Cooper-Schrieffer (BCS) pairing to a Bose-Einstein condensate (BEC) in a relativistic superfluid within a boson-fermion model. The model includes, besides the fermions, separate bosonic degrees of freedom, accounting for the bosonic nature of the Cooper pairs. The crossover is realized by tuning the difference between the boson mass and boson chemical potential as a free parameter. The model yields populations of condensed and uncondensed bosons as well as gapped and ungapped fermions throughout the crossover region for arbitrary temperatures. Moreover, we observe the appearance of antiparticles for sufficiently large values of the crossover parameter. As an application, we study pairing of fermions with imbalanced populations. The model can potentially be applied to color superconductivity in dense quark matter at strong couplings.

  6. Hyperon puzzle, hadron-quark crossover and massive neutron stars

    NASA Astrophysics Data System (ADS)

    Masuda, Kota; Hatsuda, Tetsuo; Takatsuka, Tatsuyuki

    2016-03-01

    Bulk properties of cold and hot neutron stars are studied on the basis of the hadron-quark crossover picture where a smooth transition from the hadronic phase to the quark phase takes place at finite baryon density. By using a phenomenological equation of state (EOS) "CRover", which interpolates the two phases at around 3 times the nuclear matter density (ρ0, it is found that the cold NSs with the gravitational mass larger than 2M_{odot} can be sustained. This is in sharp contrast to the case of the first-order hadron-quark transition. The radii of the cold NSs with the CRover EOS are in the narrow range (12.5 ± 0.5) km which is insensitive to the NS masses. Due to the stiffening of the EOS induced by the hadron-quark crossover, the central density of the NSs is at most 4 ρ0 and the hyperon-mixing barely occurs inside the NS core. This constitutes a solution of the long-standing hyperon puzzle. The effect of color superconductivity (CSC) on the NS structures is also examined with the hadron-quark crossover. For the typical strength of the diquark attraction, a slight softening of the EOS due to two-flavor CSC (2SC) takes place and the maximum mass is reduced by about 0.2M_{odot}. The CRover EOS is generalized to the supernova matter at finite temperature to describe the hot NSs at birth. The hadron-quark crossover is found to decrease the central temperature of the hot NSs under isentropic condition. The gravitational energy release and the spin-up rate during the contraction from the hot NS to the cold NS are also estimated.

  7. Dynamical and orientational structural crossovers in low-temperature glycerol.

    PubMed

    Seyedi, Salman; Martin, Daniel R; Matyushov, Dmitry V

    2016-07-01

    Mean-square displacements of hydrogen atoms in glass-forming materials and proteins, as reported by incoherent elastic neutron scattering, show kinks in their temperature dependence. This crossover, known as the dynamical transition, connects two approximately linear regimes. It is often assigned to the dynamical freezing of subsets of molecular modes at the point of equality between their corresponding relaxation times and the instrumental observation window. The origin of the dynamical transition in glass-forming glycerol is studied here by extensive molecular dynamics simulations. We find the dynamical transition to occur for both the center-of-mass translations and the molecular rotations at the same temperature, insensitive to changes of the observation window. Both the translational and rotational dynamics of glycerol show a dynamic crossover from the structural to a secondary relaxation at the temperature of the dynamical transition. A significant and discontinuous increase in the orientational Kirkwood factor and in the dielectric constant is observed in the same range of temperatures. No indication is found of a true thermodynamic transition to an ordered low-temperature phase. We therefore suggest that all observed crossovers are dynamic in character. The increase in the dielectric constant is related to the dynamic freezing of dipolar domains on the time scale of simulations.

  8. Case-crossover design and its implementation in R

    PubMed Central

    2016-01-01

    Case-crossover design is a variation of case-control design that it employs persons’ history periods as controls. Case-crossover design can be viewed as the hybrid of case-control study and crossover design. Characteristic confounding that is constant within one person can be well controlled with this method. The relative risk and odds ratio, as well as their 95% confidence intervals (CIs), can be estimated using Cochran-Mantel-Haenszel method. R codes for the calculation are provided in the main text. Readers may adapt these codes to their own task. Conditional logistic regression model is another way to estimate odds ratio of the exposure. Furthermore, it allows for incorporation of other time-varying covariates that are not constant within subjects. The model fitting per se is not technically difficult because there is well developed statistical package. However, it is challenging to convert original dataset obtained from case report form to that suitable to be passed to clogit() function. R code for this task is provided and explained in the text. PMID:27761445

  9. Universal crossovers between entanglement entropy and thermal entropy

    NASA Astrophysics Data System (ADS)

    Swingle, Brian; Senthil, T.

    2013-01-01

    We postulate the existence of universal crossover functions connecting the universal parts of the entanglement entropy to the low-temperature thermal entropy in gapless quantum many-body systems. These scaling functions encode the intuition that the same low-energy degrees of freedom which control low-temperature thermal physics are also responsible for the long-range entanglement in the quantum ground state. We demonstrate the correctness of the proposed scaling form and determine the scaling function for certain classes of gapless systems whose low-energy physics is described by a conformal field theory. We also use our crossover formalism to argue that local systems which are “natural” can violate the boundary law at most logarithmically. In particular, we show that several non-Fermi-liquid phases of matter have entanglement entropy that is at most of order Ld-1log(L) for a region of linear size L thereby confirming various earlier suggestions in the literature. We also briefly apply our crossover formalism to the study of fluctuations in conserved quantities and discuss some subtleties that occur in systems that spontaneously break a continuous symmetry.

  10. Dynamical and orientational structural crossovers in low-temperature glycerol.

    PubMed

    Seyedi, Salman; Martin, Daniel R; Matyushov, Dmitry V

    2016-07-01

    Mean-square displacements of hydrogen atoms in glass-forming materials and proteins, as reported by incoherent elastic neutron scattering, show kinks in their temperature dependence. This crossover, known as the dynamical transition, connects two approximately linear regimes. It is often assigned to the dynamical freezing of subsets of molecular modes at the point of equality between their corresponding relaxation times and the instrumental observation window. The origin of the dynamical transition in glass-forming glycerol is studied here by extensive molecular dynamics simulations. We find the dynamical transition to occur for both the center-of-mass translations and the molecular rotations at the same temperature, insensitive to changes of the observation window. Both the translational and rotational dynamics of glycerol show a dynamic crossover from the structural to a secondary relaxation at the temperature of the dynamical transition. A significant and discontinuous increase in the orientational Kirkwood factor and in the dielectric constant is observed in the same range of temperatures. No indication is found of a true thermodynamic transition to an ordered low-temperature phase. We therefore suggest that all observed crossovers are dynamic in character. The increase in the dielectric constant is related to the dynamic freezing of dipolar domains on the time scale of simulations. PMID:27575188

  11. Automatic identification of vessel crossovers in retinal images

    NASA Astrophysics Data System (ADS)

    Sánchez, L.; Barreira, N.; Penedo, M. G.; Cancela, B.

    2015-02-01

    Crossovers and bifurcations are interest points of the retinal vascular tree useful to diagnose diseases. Specifically, detecting these interest points and identifying which of them are crossings will give us the opportunity to search for arteriovenous nicking, this is, an alteration of the vessel tree where an artery is crossed by a vein and the former compresses the later. These formations are a clear indicative of hypertension, among other medical problems. There are several studies that have attempted to define an accurate and reliable method to detect and classify these relevant points. In this article, we propose a new method to identify crossovers. Our approach is based on segmenting the vascular tree and analyzing the surrounding area of each interest point. The minimal path between vessel points in this area is computed in order to identify the connected vessel segments and, as a result, to distinguish between bifurcations and crossovers. Our method was tested using retinographies from public databases DRIVE and VICAVR, obtaining an accuracy of 90%.

  12. Dynamical and orientational structural crossovers in low-temperature glycerol

    NASA Astrophysics Data System (ADS)

    Seyedi, Salman; Martin, Daniel R.; Matyushov, Dmitry V.

    2016-07-01

    Mean-square displacements of hydrogen atoms in glass-forming materials and proteins, as reported by incoherent elastic neutron scattering, show kinks in their temperature dependence. This crossover, known as the dynamical transition, connects two approximately linear regimes. It is often assigned to the dynamical freezing of subsets of molecular modes at the point of equality between their corresponding relaxation times and the instrumental observation window. The origin of the dynamical transition in glass-forming glycerol is studied here by extensive molecular dynamics simulations. We find the dynamical transition to occur for both the center-of-mass translations and the molecular rotations at the same temperature, insensitive to changes of the observation window. Both the translational and rotational dynamics of glycerol show a dynamic crossover from the structural to a secondary relaxation at the temperature of the dynamical transition. A significant and discontinuous increase in the orientational Kirkwood factor and in the dielectric constant is observed in the same range of temperatures. No indication is found of a true thermodynamic transition to an ordered low-temperature phase. We therefore suggest that all observed crossovers are dynamic in character. The increase in the dielectric constant is related to the dynamic freezing of dipolar domains on the time scale of simulations.

  13. In vitro and in vivo antioxidant and anti-inflammatory capacities of an antioxidant-rich fruit and berry juice blend. Results of a pilot and randomized, double-blinded, placebo-controlled, crossover study.

    PubMed

    Jensen, Gitte S; Wu, Xianli; Patterson, Kelly M; Barnes, Janelle; Carter, Steve G; Scherwitz, Larry; Beaman, Robert; Endres, John R; Schauss, Alexander G

    2008-09-24

    This study investigated the in vitro and in vivo antioxidant and anti-inflammatory properties of a juice blend (JB), MonaVie Active, containing a mixture of fruits and berries with known antioxidant activity, including acai, a palm fruit, as the predominant ingredient. The phytochemical antioxidants in the JB are primarily in the form of anthocyanins, predominantly cyanidin 3-rutoside, cyanidin 3-diglycoside, and cyanidin 3-glucoside. The cell-based antioxidant protection of erythrocytes (CAP-e) assay demonstrated that antioxidants in the JB penetrated and protected cells from oxidative damage ( p < 0.001), whereas polymorphonuclear cells showed reduced formation of reactive oxygen species ( p < 0.003) and reduced migration toward three different pro-inflammatory chemoattractants: fmlp ( p < 0.001), leukotriene B4 ( p < 0.05), and IL-8 ( p < 0.03). A randomized, double-blinded, placebo-controlled, crossover trial with 12 healthy subjects examined the JB's antioxidant activity in vivo. Blood samples at baseline, 1 h, and 2 h following consumption of the JB or placebo were tested for antioxidant capacity using several antioxidant assays and the TBARS assay, a measure of lipid peroxidation. A within subject comparison showed an increase in serum antioxidants at 1 h ( p < 0.03) and 2 h ( p < 0.015), as well as inhibition of lipid peroxidation at 2 h ( p < 0.01) postconsumption.

  14. A randomized, rater-blinded, crossover study comparing the clinical efficacy of Ritalin(®) LA (methylphenidate) treatment in children with attention-deficit hyperactivity disorder under different breakfast conditions over 2 weeks.

    PubMed

    Schulz, Eberhard; Fleischhaker, Christian; Hennighausen, Klaus; Heiser, Philip; Haessler, Frank; Linder, Martin; Stollhoff, Kirsten; Warnke, Andreas; Baier, Monika; Klatt, Jan

    2010-11-01

    Several extended-release methylphenidate medications are available for treatment of children with ADHD. Pharmacokinetic investigations suggest that the serum levels of methylphenidate are partially altered when the medication is taken without breakfast. Clinical data comparing different breakfast situations are missing. In this study, different breakfast compositions and their influence on treatment with Ritalin LA are investigated. A total of 150 patients were enrolled in a rater-blinded, randomized crossover trial that compared a minimal breakfast with a standard breakfast in patients under stable treatment with Ritalin LA. Ratings for clinical efficacy were carried out after 1 week by teachers and parents (FBB-ADHS), as well as physicians (CGI). Additionally, a math test was administered to the patients. Of the total patients, 144 finished the trial with a breakfast compliance of 93%. All of the clinical rating scales showed consistently no difference between the two breakfast conditions. Non-inferiority of minimal breakfast versus standard breakfast was shown to be statistically significant (FBB-AHDS(Teacher): 0.97 with minimal breakfast, 1.01 with standard breakfast, P < 0.0001). The clinical efficacy of Ritalin LA is not influenced by breakfast and works independently of food intake.

  15. Effects of Enteric-coated Lactoferrin Tablets Containing Lactobacillus brevis subsp. coagulans on Fecal Properties, Defecation Frequency and Intestinal Microbiota of Japanese Women with a Tendency for Constipation: a Randomized Placebo-controlled Crossover Study

    PubMed Central

    SUZUKI, Noriyuki; MURAKOSHI, Michiaki; ONO, Tomoji; MORISHITA, Satoru; KOIDE, Misao; BAE, Min Jung; TOTSUKA, Mamoru; SHIMIZU, Makoto; SUGIYAMA, Keikichi; NISHINO, Hoyoku; IIDA, Norio

    2013-01-01

    The effects of oral administration of enteric-coated tablets containing lactoferrin (LF; 100 mg/tablet) and heat-killed Lactobacillus brevis subsp. coagulans FREM BP-4693 (LB; 6×109 bacteria/tablet) on fecal properties were examined in 32 Japanese women (20–60 years of age) with a tendency for constipation (defecation frequency at equal to or less than 10 times/2 weeks) by a double-blind placebo-controlled crossover design. A significant increase in defecation days per week was obserbed in the subjects who ingested the tablets containing LF and LB compared with the placebo group. The number of bifidobacteria in feces also significantly increased compared with the placebo group. In an in vitro study, LF and tryptic hydrolysate of LF, but not peptic hydrolysate of LF, upregulated the growth of Bifidobacterium longum ATCC15707 when added to the culture. These results demonstrate the capability of the enteric-coated tablets containing LF and LB in improving intestinal function and suggest that they have a growth promoting function for bifidobacteria. PMID:24936358

  16. Analysis of Crossovers in the Interbeat Sequences of Elderly Individuals and Heart Failure Patients

    NASA Astrophysics Data System (ADS)

    Muñoz-Diosdado, A.; del Río Correa, J. L.

    2006-09-01

    Many physical and biological systems exhibit complex behavior characterized by long-range power-law correlations. Detrended fluctuation analysis (DFA) is a scaling analysis method that provides a scaling parameter to represent the correlation properties of a signal. The study of interbeat sequences with the DFA method has revealed the presence of crossovers associated with physiological aging and heart with failure; the hinges present in the crossover region from both the elderly healthy individuals and the patients with congestive heart failure (CHF) are in opposite directions. The interbeat sequences of healthy young persons do not show crossovers. In this paper we study interbeat time series of healthy young and elderly persons and patients with CHF. We use the DFA-m method, where m refers to the order of the polynomial function used for the fitting. For instance, DFA-2 filters linear trends and DFA-3 filters quadratic trends. We found that the presence of the crossovers and the direction of the hinges are conserved when we apply the DFA method for different values of m. Therefore we conclude that the DFA-m method is a reliable method to accurately quantify correlations in interbeat time series even if there are polynomial trends. We can characterize the crossovers and we can conclude that the crossovers are not a result of the trends; they are part of the system dynamics.

  17. The dynamical crossover in attractive colloidal systems.

    PubMed

    Mallamace, Francesco; Corsaro, Carmelo; Stanley, H Eugene; Mallamace, Domenico; Chen, Sow-Hsin

    2013-12-01

    We study the dynamical arrest in an adhesive hard-sphere colloidal system. We examine a micellar suspension of the Pluronic-L64 surfactant in the temperature (T) and volume fraction (φ) phase diagram. According to mode-coupling theory (MCT), this system is characterized by a cusp-like singularity and two glassy phases: an attractive glass (AG) phase and a repulsive glass (RG) phase. The T - φ phase diagram of this system as confirmed by a previous series of scattering data also exhibits a Percolation Threshold (PT) line, a reentrant behavior (AG-liquid-RG), and a glass-to-glass transition. The AG phase can be generated out of the liquid phase by using T and φ as control parameters. We utilize viscosity and nuclear magnetic resonance (NMR) techniques. NMR data confirm all the characteristic properties of the colloidal system phase diagram and give evidence of the onset of a fractal-like percolating structure at a precise threshold. The MCT scaling laws used to study the shear viscosity as a function of φ and T show in both cases a fragile-to-strong liquid glass-forming dynamic crossover (FSC) located near the percolation threshold where the clustering process is fully developed. These results suggest a larger thermodynamic generality for this phenomenon, which is usually studied only as a function of the temperature. We also find that the critical values of the control parameters, coincident with the PT line, define the locus of the FSC. In the region between the FSC and the glass transition lines the system dynamics are dominated by clustering effects. We thus demonstrate that it is possible, using the conceptual framework provided by extended mode-coupling theory, to describe the way a system approaches dynamic arrest, taking into account both cage and hopping effects.

  18. The dynamical crossover in attractive colloidal systems

    SciTech Connect

    Mallamace, Francesco; Corsaro, Carmelo; Stanley, H. Eugene; Mallamace, Domenico; Chen, Sow-Hsin

    2013-12-07

    We study the dynamical arrest in an adhesive hard-sphere colloidal system. We examine a micellar suspension of the Pluronic-L64 surfactant in the temperature (T) and volume fraction (ϕ) phase diagram. According to mode-coupling theory (MCT), this system is characterized by a cusp-like singularity and two glassy phases: an attractive glass (AG) phase and a repulsive glass (RG) phase. The T − ϕ phase diagram of this system as confirmed by a previous series of scattering data also exhibits a Percolation Threshold (PT) line, a reentrant behavior (AG-liquid-RG), and a glass-to-glass transition. The AG phase can be generated out of the liquid phase by using T and ϕ as control parameters. We utilize viscosity and nuclear magnetic resonance (NMR) techniques. NMR data confirm all the characteristic properties of the colloidal system phase diagram and give evidence of the onset of a fractal-like percolating structure at a precise threshold. The MCT scaling laws used to study the shear viscosity as a function of ϕ and T show in both cases a fragile-to-strong liquid glass-forming dynamic crossover (FSC) located near the percolation threshold where the clustering process is fully developed. These results suggest a larger thermodynamic generality for this phenomenon, which is usually studied only as a function of the temperature. We also find that the critical values of the control parameters, coincident with the PT line, define the locus of the FSC. In the region between the FSC and the glass transition lines the system dynamics are dominated by clustering effects. We thus demonstrate that it is possible, using the conceptual framework provided by extended mode-coupling theory, to describe the way a system approaches dynamic arrest, taking into account both cage and hopping effects.

  19. A randomized, double-blind, placebo-controlled, cross-over study to assess the efficacy of tadalafil (Cialis[reg]) in the treatment of erectile dysfunction following three-dimensional conformal external-beam radiotherapy for prostatic carcinoma

    SciTech Connect

    Incrocci, Luca . E-mail: l.incrocci@erasmusmc.nl; Slagter, Cleo; Slob, A. Koos; Hop, Wim C.J.

    2006-10-01

    Purpose: Erectile dysfunction after three-dimensional conformal external-beam radiotherapy (3DCRT) for prostatic carcinoma is reported in as many as 64% of those patients. The purpose of this study was to determine the efficacy of the oral drug tadalafil (Cialis (registered) ) in patients with erectile dysfunction after radiotherapy for prostatic carcinoma. Methods and Materials: Patients (N = 358) who completed radiotherapy at least 12 months before the study were approached by mail. All patients had been treated by 3DCRT; 60 patients were included and entered a double-blind, placebo-controlled, cross-over study lasting 12 weeks. They received 20 mg of tadalafil or placebo for 6 weeks. Drug or placebo was taken on demand at patient's discretion, with no restrictions regarding the consumption of alcohol or food, at least once a week and no more than once daily. At 6 weeks patients crossed over to the alternative treatment. Data were collected using the Sexual Encounter Profile (SEP) and the International Index of Erectile Function (IIEF) questionnaires. Side effects were also recorded. Results: Mean age at study entry was 69 years. All patients completed the study. For almost all questions of the IIEF questionnaire there was a significant increase in mean scores from baseline with tadalafil, but not with placebo. Sixty-seven percent of the patients reported an improvement of erectile function with tadalafil (placebo: 20%), and 48% reported successful intercourse with tadalafil (placebo: 9%) (p < 0.0001). Side effects were mild or moderate. Conclusions: Tadalafil is an effective treatment for erectile dysfunction after 3DCRT for prostatic carcinoma with successful intercourse reported in almost 50% of the patients, and it is well tolerated.

  20. Investigation on the clinical efficacy and safety of 0.1% tacrolimus ointment (Protopic) in canine atopic dermatitis: a randomized, double-blinded, placebo-controlled, cross-over study.

    PubMed

    Marsella, R; Nicklin, C F; Saglio, S; Lopez, J

    2004-10-01

    Topical tacrolimus is successfully used in people with atopic dermatitis. Preliminary studies in dogs with atopic dermatitis using tacrolimus in a compounded lotion formulation indicated that tacrolimus significantly decreased erythema and pruritus according to investigator, but no significant improvement was reported by the dog owners. The objectives of this study were to evaluate the clinical efficacy and safety of the commercially available 0.1% tacrolimus ointment (Protopic) in dogs with atopic dermatitis. The study was designed as a double-blinded, placebo-controlled, cross-over study. Selected dogs were allocated to either tacrolimus or placebo for 4 weeks. After 4 weeks there was a wash-out period of 2 weeks and treatments were switched. Twelve dogs completed the study. Clinical signs were scored. Blood samples were collected for complete blood count, chemistry panels and tacrolimus levels at week 0 and 4 of each treatment. Tacrolimus ointment significantly decreased severity of symptoms for both owners and investigators at the end of the trial. When the same dogs received the placebo, there were no differences between week 0 and week 4 scores. Dogs with localized disease responded better than dogs with generalized disease. Tacrolimus was detected in the blood of animals receiving the active ingredient. Levels were below the level of toxicity and no adverse effects were reported in any of the dogs. No changes in complete blood count and chemistry parameters were detected between groups or within groups. In conclusion, tacrolimus appears to be a safe alternative treatment in dogs with atopic dermatitis, especially in those with localized disease.

  1. Spin crossover properties of enantiomers, co-enantiomers, racemates, and co-racemates.

    PubMed

    Qin, Long-Fang; Pang, Chun-Yan; Han, Wang-Kang; Zhang, Feng-Li; Tian, Lei; Gu, Zhi-Guo; Ren, Xuehong; Li, Zaijun

    2016-04-25

    Through multi-component self-assembly of chiral phenylethylamine, 1-alkyl-2-imidazolecarboxaldehyde and iron(ii) ions, two couples of enantiomeric iron(ii) complexes , , and with the formula of fac-Λ or Δ-[Fe(L)3](2+)(L = R or S-1-phenyl-N-(1-alkyl-1H-imidazol-2-ylmethylene)ethanamine) have been designed and synthesized as building blocks. Further binary cocrystallization of the prefabricated enantiomers enabled us to construct spin crossover co-enantiomers and , racemates and , and co-racemate . Compared with in a high spin state and with spin crossover at 291 K, the co-enantiomers exhibited gradual spin crossover at a higher temperature of 301 K, and the racemic alloys showed hysteresis loops induced by desolvation above room temperature. It was demonstrated that molecular chirality could be used effectively for stereochemical engineering of spin crossover materials. In addition, crystal packing, intramolecular π-π stacking, intermolecular C-Hπ interactions and solvent effects were elucidated to be responsible for the distinct spin crossover properties. This collective structural and magnetic study not only enriched the spin crossover library, but also provided a full comparison of optically pure, homochiral, and racemic materials with similar molecular structures. PMID:27021212

  2. The Design of Cluster Randomized Crossover Trials

    ERIC Educational Resources Information Center

    Rietbergen, Charlotte; Moerbeek, Mirjam

    2011-01-01

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

  3. Cedarwood: cross-over pressure research

    Technology Transfer Automated Retrieval System (TEKTRAN)

    A series of experiments were conducted to determine the cross-over pressure for cedarwood oil in carbon dioxide. A closed stirrer reactor with an in-line loop connected to the injector of a GC was used to measure the concentration of cedarwood oil in the carbon dioxide. Both neat cedarwood oil as ...

  4. Effect of supplementation of fermented milk drink containing probiotic Lactobacillus casei Shirota on the concentrations of aflatoxin biomarkers among employees of Universiti Putra Malaysia: a randomised, double-blind, cross-over, placebo-controlled study.

    PubMed

    Mohd Redzwan, Sabran; Abd Mutalib, Mohd Sokhini; Wang, Jia-Sheng; Ahmad, Zuraini; Kang, Min-Su; Abdul Rahman, Nurul 'Aqilah; Nikbakht Nasrabadi, Elham; Jamaluddin, Rosita

    2016-01-14

    Human exposure to aflatoxin is through the diet, and probiotics are able to bind aflatoxin and prevent its absorption in the small intestine. This study aimed to determine the effectiveness of a fermented milk drink containing Lactobacillus casei Shirota (LcS) (probiotic drink) to prevent aflatoxin absorption and reduce serum aflatoxin B1-lysine adduct (AFB1-lys) and urinary aflatoxin M1 concentrations. The present study was a randomised, double-blind, cross-over, placebo-controlled study with two 4-week intervention phases. In all, seventy-one subjects recruited from the screening stage were divided into two groups--the Yellow group and the Blue group. In the 1st phase, one group received probiotic drinks twice a day and the other group received placebo drinks. Blood and urine samples were collected at baseline, 2nd and 4th week of the intervention. After a 2-week wash-out period, the treatments were switched between the groups, and blood and urine samples were collected at the 6th, 8th and 10th week (2nd phase) of the intervention. No significant differences in aflatoxin biomarker concentrations were observed during the intervention. A within-group analysis was further carried out. Aflatoxin biomarker concentrations were not significantly different in the Yellow group. Nevertheless, ANOVA for repeated measurements indicated that AFB1-lys concentrations were significantly different (P=0·035) with the probiotic intervention in the Blue group. The 2nd week AFB1-lys concentrations (5·14 (SD 2·15) pg/mg albumin (ALB)) were significantly reduced (P=0·048) compared with the baseline (6·24 (SD 3·42) pg/mg ALB). Besides, the 4th week AFB1-lys concentrations were significantly lower (P<0·05) with probiotic supplementation than with the placebo. Based on these findings, a longer intervention study is warranted to investigate the effects of continuous LcS consumption to prevent dietary aflatoxin exposure.

  5. Effect of a fermented dietary supplement containing chromium and zinc on metabolic control in patients with type 2 diabetes: a randomized, placebo-controlled, double-blind cross-over study

    PubMed Central

    Lee, Yu-Mi; Wolf, Petra; Hauner, Hans; Skurk, Thomas

    2016-01-01

    Background For the increasing development of type 2 diabetes dietary habits play an important role. In this regard, dietary supplements are of growing interest to influence the progression of this disease. Objective The aim of this study was to investigate the effect of a cascade-fermented dietary supplement based on fruits, nuts, and vegetables fortified with chromium and zinc on metabolic control in patients with type 2 diabetes mellitus. Methods This was a randomized, placebo-controlled, double-blind, intervention study under free-living conditions using a cross-over design. Thirty-six patients with type 2 diabetes mellitus were enrolled and randomized either to receive a cascade-fermented dietary supplement enriched with chromium (100 µg/d) and zinc (15 mg/d) or a placebo similar in taste but without supplements, over a period of 12 weeks. After a wash-out period of 12 weeks, the patients received the other test product. The main outcome variable was the levels of glycated hemoglobin (HbA1c). Other outcome variables were fasting blood glucose, fructosamine, and lipid parameters. Results Thirty-one patients completed the study. HbA1c showed no relevant changes during both treatment periods, nor was there a relevant difference between the two treatments (HbA1c: p=0.48). The same results were found for fructosamine and fasting glucose (fructosamine: p=0.9; fasting glucose: p=0.31). In addition, there was no effect on lipid metabolism. Conclusion This intervention study does not provide evidence that a cascade-fermented plant-based dietary supplement enriched with a combination of chromium and zinc improves glucose metabolism in patients with type 2 diabetes mellitus under free-living conditions. PMID:27343205

  6. Evaluation of the gastrointestinal tolerability of corn starch fiber, a novel dietary fiber, in two independent randomized, double-blind, crossover studies in healthy men and women.

    PubMed

    Crincoli, Christine M; Garcia-Campayo, Vicenta; Rihner, Marisa O; Nikiforov, Andrey I; Liska, DeAnn; van de Ligt, Jennifer L G

    2016-11-01

    Two independent clinical studies were conducted to compare the gastrointestinal (GI) tolerability of corn starch fiber, a novel dietary fiber, at up to 50 g/day (single-dose study) or 90 g/day (multiple-serving study) with a negative control (no fiber) and a positive control (50 or 90 g polydextrose, for single- and multiple-serving studies, respectively) in generally healthy study volunteers. Flatulence and borborygmus were the primary symptoms reported at the higher doses of corn starch fiber and for the positive control interventions. Bowel movements were increased over 48 h with corn starch fiber at 90 g. Thresholds for mild GI effects were established at 30 g as a single dose and 60 g as multiple servings spread over the day. Other than moderate abdominal pain and mild increased appetite in one subject at 90-g corn starch fiber, no test article-related adverse events were reported.

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

    PubMed

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

    2015-04-28

    It is widely assumed that nutrition can improve school performance in children; however, evidence remains limited and inconclusive. In the present study, we investigated whether serving healthy school meals influenced concentration and school performance of 8- to 11-year-old Danish children. The OPUS (Optimal well-being, development and health for Danish children through a healthy New Nordic Diet) School Meal Study was a cluster-randomised, controlled, cross-over trial comparing a healthy school meal programme with the usual packed lunch from home (control) each for 3 months (NCT 01457794). The d2 test of attention, the Learning Rating Scale (LRS) and standard tests on reading and mathematics proficiency were administered at baseline and at the end of each study period. Intervention effects were evaluated using hierarchical mixed models. The school meal intervention did not influence concentration performance (CP; primary outcome, n 693) or processing speed; however, the decrease in error percentage was 0·18 points smaller (P<0·001) in the intervention period than in the control period (medians: baseline 2·03%; intervention 1·46%; control 1·37%). In contrast, the intervention increased reading speed (0·7 sentence, P=0·009) and the number of correct sentences (1·8 sentences, P<0·001), which corresponded to 11 and 25%, respectively, of the effect of one school year. The percentage of correct sentences also improved (P<0·001), indicating that the number correct improved relatively more than reading speed. There was no effect on overall math performance or outcomes from the LRS. In conclusion, school meals did not affect CP, but improved reading performance, which is a complex cognitive activity that involves inference, and increased errors related to impulsivity and inattention. These findings are worth examining in future trials. PMID:25791747

  8. Green tea extract decreases starch digestion and absorption from a test meal in humans: a randomized, placebo-controlled crossover study.

    PubMed

    Lochocka, Klaudia; Bajerska, Joanna; Glapa, Aleksandra; Fidler-Witon, Ewa; Nowak, Jan K; Szczapa, Tomasz; Grebowiec, Philip; Lisowska, Aleksandra; Walkowiak, Jaroslaw

    2015-07-30

    Green tea is known worldwide for its beneficial effects on human health. However, objective data evaluating this influence in humans is scarce. The aim of the study was to assess the impact of green tea extract (GTE) on starch digestion and absorption. The study comprised of 28 healthy volunteers, aged 19 to 28 years. In all subjects, a starch (13)C breath test was performed twice. Subjects randomly ingested naturally (13)C-abundant cornflakes during the GTE test (GTE 4 g) or placebo test. The cumulative percentage dose recovery (CPDR) was significantly lower for the GTE test than for the placebo test (median [interquartile range]: 11.4% [5.5-15.5] vs. 16.1% [12.7-19.5]; p = 0.003). Likewise, CPDR expressed per hour was considerably lower in each point of the measurement. In conclusion, a single dose of green tea extract taken with a test meal decreases starch digestion and absorption.

  9. A randomized double-blind crossover trial of deep brain stimulation of the subcallosal cingulate gyrus in patients with treatment-resistant depression: a pilot study of relapse prevention

    PubMed Central

    Puigdemont, Dolors; Portella, Maria J.; Pérez-Egea, Rosario; Molet, Joan; Gironell, Alexandre; de Diego-Adeliño, Javier; Martín, Anna; Rodríguez, Rodrigo; Àlvarez, Enric; Artigas, Francesc; Pérez, Víctor

    2015-01-01

    Background To date, antidepressant drugs show limited efficacy, leaving a large number of patients experiencing severe and persistent symptoms of major depression. Previous open-label clinical trials have reported significant sustained improvements with deep brain stimulation (DBS) of the subcallosal cingulate gyrus (SCG) in patients with severe, chronic treatment-resistant depression (TRD). This study aimed to confirm the efficacy and measure the impact of discontinuation of the electrical stimulation. Methods We conducted a 6-month double-blind, randomized, sham-controlled crossover study in implanted patients with previous severe TRD who experienced full remission after chronic stimulation. After more than 3 months of stable remission, patients were randomly assigned to 2 treatment arms: the ON–OFF arm, which involved active electrode stimulation for 3 months followed by sham stimulation for 3 months, and the OFF–ON arm, which involved sham stimulation for 3 months followed by active stimulation for 3 months. The primary outcome measure was the difference in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score between sham and active stimulation. Results We enrolled 5 patients in our trial. A Friedman repeated-measures analysis of variance revealed a significant effect of treatment (χ21 = 5.0, p = 0.025) in patients with higher depression scores during sham stimulation. At the end of active stimulation, depression was remitted in 4 of 5 patients and none of them had experienced a relapse, whereas at the end of sham stimulation, 2 patients remained in remission, 2 relapsed and 1 showed a progressive worsening without reaching relapse criteria. Limitations The small sample size limited the statistical power and external validity. Conclusion These preliminary findings indicate that DBS of the SCG is an effective and safe treatment for severe forms of TRD and that continuous electrical stimulation is required to maintain therapeutic effects

  10. Increased gut hormones and insulin sensitivity index following a 3-d intervention with a barley kernel-based product: a randomised cross-over study in healthy middle-aged subjects.

    PubMed

    Nilsson, Anne C; Johansson-Boll, Elin V; Björck, Inger M E

    2015-09-28

    Certain purified indigestible carbohydrates such as inulin have been shown to stimulate gut-derived hormones involved in glycaemic regulation and appetite regulation, and to counteract systemic inflammation through a gut microbiota-mediated mechanism. Less is known about the properties of indigestible carbohydrates intrinsic to food. The aim of this study was to investigate the possibility to affect release of endogenous gut hormones and ameliorate appetite control and glycaemic control by ingestion of a whole-grain cereal food product rich in NSP and resistant starch in healthy humans. In all, twenty middle-aged subjects were provided with a barley kernel-based bread (BB) or a reference white wheat bread during 3 consecutive days, respectively, in a randomised cross-over design study. At a standardised breakfast the following day (day 4), blood was collected for the analysis of blood (b) glucose regulation, gastrointestinal hormones, markers of inflammation and markers of colonic fermentation; 3 d of intervention with BB increased gut hormones in plasma (p) the next morning at fasting (p-glucagon-like peptide-1; 56%) and postprandially (p-glucagon-like peptide-2; 13% and p-peptide YY; 18%). Breath H₂ excretion and fasting serum (s) SCFA concentrations were increased (363 and 18%, respectively), and b-glucose (22%) and s-insulin responses (17%) were decreased after BB intervention. Insulin sensitivity index (ISI(composite)) was also improved (25%) after BB. In conclusion, 3 d of intervention with BB increased systemic levels of gut hormones involved in appetite regulation, metabolic control and maintenance of gut barrier function, as well as improved markers of glucose homoeostasis in middle-aged subjects, altogether relevant for the prevention of obesity and the metabolic syndrome. PMID:26259632

  11. Biased agonism of the μ-opioid receptor by TRV130 increases analgesia and reduces on-target adverse effects versus morphine: A randomized, double-blind, placebo-controlled, crossover study in healthy volunteers.

    PubMed

    Soergel, David G; Subach, Ruth Ann; Burnham, Nancy; Lark, Michael W; James, Ian E; Sadler, Brian M; Skobieranda, Franck; Violin, Jonathan D; Webster, Lynn R

    2014-09-01

    Opioids provide powerful analgesia but also efficacy-limiting adverse effects, including severe nausea, vomiting, and respiratory depression, by activating μ-opioid receptors. Preclinical models suggest that differential activation of signaling pathways downstream of these receptors dissociates analgesia from adverse effects; however, this has not yet translated to a treatment with an improved therapeutic index. Thirty healthy men received single intravenous injections of the biased ligand TRV130 (1.5, 3, or 4.5mg), placebo, or morphine (10mg) in a randomized, double-blind, crossover study. Primary objectives were to measure safety and tolerability (adverse events, vital signs, electrocardiography, clinical laboratory values), and analgesia (cold pain test) versus placebo. Other measures included respiratory drive (minute volume after induced hypercapnia), subjective drug effects, and pharmacokinetics. Compared to morphine, TRV130 (3, 4.5mg) elicited higher peak analgesia (105, 116 seconds latency vs 75 seconds for morphine, P<.02), with faster onset and similar duration of action. More subjects doubled latency or achieved maximum latency (180 seconds) with TRV130 (3, 4.5mg). Respiratory drive reduction was greater after morphine than any TRV130 dose (-15.9 for morphine versus -7.3, -7.6, and -9.4 h*L/min, P<.05). More subjects experienced severe nausea after morphine (n=7) than TRV130 1.5 or 3mg (n=0, 1), but not 4.5mg (n=9). TRV130 was generally well tolerated, and exposure was dose proportional. Thus, in this study, TRV130 produced greater analgesia than morphine at doses with less reduction in respiratory drive and less severe nausea. This demonstrates early clinical translation of ligand bias as an important new concept in receptor-targeted pharmacotherapy.

  12. Biased agonism of the μ-opioid receptor by TRV130 increases analgesia and reduces on-target adverse effects versus morphine: A randomized, double-blind, placebo-controlled, crossover study in healthy volunteers.

    PubMed

    Soergel, David G; Subach, Ruth Ann; Burnham, Nancy; Lark, Michael W; James, Ian E; Sadler, Brian M; Skobieranda, Franck; Violin, Jonathan D; Webster, Lynn R

    2014-09-01

    Opioids provide powerful analgesia but also efficacy-limiting adverse effects, including severe nausea, vomiting, and respiratory depression, by activating μ-opioid receptors. Preclinical models suggest that differential activation of signaling pathways downstream of these receptors dissociates analgesia from adverse effects; however, this has not yet translated to a treatment with an improved therapeutic index. Thirty healthy men received single intravenous injections of the biased ligand TRV130 (1.5, 3, or 4.5mg), placebo, or morphine (10mg) in a randomized, double-blind, crossover study. Primary objectives were to measure safety and tolerability (adverse events, vital signs, electrocardiography, clinical laboratory values), and analgesia (cold pain test) versus placebo. Other measures included respiratory drive (minute volume after induced hypercapnia), subjective drug effects, and pharmacokinetics. Compared to morphine, TRV130 (3, 4.5mg) elicited higher peak analgesia (105, 116 seconds latency vs 75 seconds for morphine, P<.02), with faster onset and similar duration of action. More subjects doubled latency or achieved maximum latency (180 seconds) with TRV130 (3, 4.5mg). Respiratory drive reduction was greater after morphine than any TRV130 dose (-15.9 for morphine versus -7.3, -7.6, and -9.4 h*L/min, P<.05). More subjects experienced severe nausea after morphine (n=7) than TRV130 1.5 or 3mg (n=0, 1), but not 4.5mg (n=9). TRV130 was generally well tolerated, and exposure was dose proportional. Thus, in this study, TRV130 produced greater analgesia than morphine at doses with less reduction in respiratory drive and less severe nausea. This demonstrates early clinical translation of ligand bias as an important new concept in receptor-targeted pharmacotherapy. PMID:24954166

  13. Pioglitazone Improves Fat Distribution, the Adipokine Profile and Hepatic Insulin Sensitivity in Non-Diabetic End-Stage Renal Disease Subjects on Maintenance Dialysis: A Randomized Cross-Over Pilot Study

    PubMed Central

    Zanchi, Anne; Tappy, Luc; Lê, Kim-Anne; Bortolotti, Murielle; Theumann, Nicolas; Halabi, Georges; Gauthier, Thierry; Mathieu, Claudine; Tremblay, Sylvie; Bertrand, Pauline Coti; Burnier, Michel; Teta, Daniel

    2014-01-01

    Background Fat redistribution, increased inflammation and insulin resistance are prevalent in non-diabetic subjects treated with maintenance dialysis. The aim of this study was to test whether pioglitazone, a powerful insulin sensitizer, alters body fat distribution and adipokine secretion in these subjects and whether it is associated with improved insulin sensitivity. Trial Design This was a double blind cross-over study with 16 weeks of pioglitazone 45 mg vs placebo involving 12 subjects. Methods At the end of each phase, body composition (anthropometric measurements, dual energy X-ray absorptometry (DEXA), abdominal CT), hepatic and muscle insulin sensitivity (2-step hyperinsulinemic euglycemic clamp with 2H2-glucose) were measured and fasting blood adipokines and cardiometabolic risk markers were monitored. Results Four months treatment with pioglitazone had no effect on total body weight or total fat but decreased the visceral/sub-cutaneous adipose tissue ratio by 16% and decreased the leptin/adiponectin (L/A) ratio from 3.63×10−3 to 0.76×10−3. This was associated with a 20% increase in hepatic insulin sensitivity without changes in muscle insulin sensitivity, a 12% increase in HDL cholesterol and a 50% decrease in CRP. Conclusions/Limitations Pioglitazone significantly changes the visceral-subcutaneous fat distribution and plasma L/A ratio in non diabetic subjects on maintenance dialysis. This was associated with improved hepatic insulin sensitivity and a reduction of cardio-metabolic risk markers. Whether these effects may improve the outcome of non diabetic end-stage renal disease subjects on maintenance dialysis still needs further evaluation. Trial Registration ClinicalTrial.gov NCT01253928 PMID:25330088

  14. An acute, double-blind, placebo-controlled cross-over study of 320 mg and 640 mg doses of Bacopa monnieri (CDRI 08) on multitasking stress reactivity and mood.

    PubMed

    Benson, Sarah; Downey, Luke A; Stough, Con; Wetherell, Mark; Zangara, Andrea; Scholey, Andrew

    2014-04-01

    Little research exists in humans concerning the anxiolytic, antidepressant, sedative, and adaptogenic actions the traditional Ayurvedic medicine Bacopa monnieri (BM) possesses in addition to its documented cognitive-enhancing effects. Preclinical work has identified a number of acute anxiolytic, nootropic, and adaptogenic effects of BM that may also co-occur in humans. The current double-blind, placebo-controlled cross-over study assessed the acute effects of a specific extract of BM (KeenMind® - CDRI 08) in normal healthy participants during completion of a multitasking framework (MTF). Seventeen healthy volunteers completed the MTF, at baseline, then 1 h and 2 h after consuming a placebo, 320 mg BM and 640 mg of BM. Treatments were separated by a 7-day washout with order determined by Latin Square. Outcome measures included cognitive outcomes from the MTF, with mood and salivary cortisol measured before and after each completion of the MTF. Change from baseline scores indicated positive cognitive effects, notably at both 1 h post and 2 h post BM consumption on the Letter Search and Stroop tasks, suggesting an earlier nootropic effect of BM than previously investigated. There were also some positive mood effects and reduction in cortisol levels, pointing to a physiological mechanism for stress reduction associated with BM consumption. It was concluded that acute BM supplementation produced some adaptogenic and nootropic effects that need to be replicated in a larger sample and in isolation from stressful cognitive tests in order to quantify the magnitude of these effects. The study was registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12612000834853).

  15. An open-label, multicenter, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in Chinese men naïve to phosphodiesterase 5 inhibitor therapy

    PubMed Central

    Bai, Wen-Jun; Li, Hong-Jun; Dai, Yu-Tian; He, Xue-You; Huang, Yi-Ran; Liu, Ji-Hong; Sorsaburu, Sebastian; Ji, Chen; Jin, Jian-Jun; Wang, Xiao-Feng

    2015-01-01

    The study was to compare treatment preference, efficacy, and tolerability of sildenafil citrate (sildenafil) and tadalafil for treating erectile dysfunction (ED) in Chinese men naïve to phosphodiesterase 5 (PDE5) inhibitor therapies. This multicenter, randomized, open-label, crossover study evaluated whether Chinese men with ED preferred 20-mg tadalafil or 100-mg sildenafil. After a 4 weeks baseline assessment, 383 eligible patients were randomized to sequential 20-mg tadalafil per 100-mg sildenafil or vice versa for 8 weeks respectively and then chose which treatment they preferred to take during the 8 weeks extension. Primary efficacy was measured by Question 1 of the PDE5 Inhibitor Treatment Preference Questionnaire (PITPQ). Secondary efficacy was analyzed by PITPQ Question 2, the International Index of Erectile Function (IIEF) erectile function (EF) domain, sexual encounter profile (SEP) Questions 2 and 3, and the Drug Attributes Questionnaire. Three hundred and fifty men (91%) completed the randomized treatment phase. Two hundred and forty-two per 350 (69.1%) patients preferred 20-mg tadalafil, and 108/350 (30.9%) preferred 100-mg sildenafil (P < 0.001) as their treatment in the 8 weeks extension. Ninety-two per 242 (38%) patients strongly preferred tadalafil and 37/108 (34.3%) strongly the preferred sildenafil. The SEP2 (penetration), SEP3 (successful intercourse), and IIEF-EF domain scores were improved in both tadalafil and sildenafil treatment groups. For patients who preferred tadalafil, getting an erection long after taking the medication was the most reported reason for tadalafil preference. The only treatment-emergent adverse event reported by > 2% of men was headache. After tadalafil and sildenafil treatments, more Chinese men with ED naïve to PDE5 inhibitor preferred tadalafil. Both sildenafil and tadalafil treatments were effective and safe. PMID:25370206

  16. A randomized, double-blind, placebo-controlled crossover study of α4β2* nicotinic acetylcholine receptor agonist AZD1446 (TC-6683) in adults with attention-deficit/hyperactivity disorder

    PubMed Central

    Öhd, John; Potter, Alexandra S.; Jaeger, Judith; Karlsson, Pär; Hannesdottir, Kristin; Boström, Emma; Newhouse, Paul A.; Paulsson, Björn

    2013-01-01

    Rationale Stimulation of nicotinic cholinergic systems has been shown to alleviate ADHD symptoms and to improve cognitive performance. AZD1446 is a selective α4β2* nicotinic acetylcholine receptor agonist with potential effect on the symptoms of ADHD. Objectives The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of AZD1446 in adults with ADHD treated for 2 weeks. Method This was a randomized, double-blind, placebo-controlled crossover trial. Participants were 79 adults with ADHD, grouped according to their use of nicotine-containing products. Nicotine non-users received placebo and two of three AZD1446 treatment regimens (80 mg tid, 80 mg qd, 10 mg tid). Nicotine users received placebo, AZD1446 80 mg tid and 80 mg qd. Efficacy measures included the Conners' Adult ADHD Rating Scale and cognitive measures of immediate and delayed verbal episodic memory, learning, attention, working memory, executive functioning, and spatial problem solving (CogState computerized test battery). Results There was no significant effect of AZD1446 on any of the clinical scores irrespective of dose, schedule, or concomitant use of nicotine products. A statistically significant improvement was seen on the Groton Maze Learning Task, a measure of executive functioning, in nicotine non-users after treatment with AZD1446 80 mg qd. Conclusions AZD1446 was well tolerated, but did not significantly improve ADHD symptoms after 2 weeks of treatment compared to placebo. While the present study does not support the therapeutic utility of AZD1446 in ADHD, its potential pro-cognitive effects remain to be explored in other neuropsychiatric disorders. PMID:23640072

  17. An acute, double-blind, placebo-controlled cross-over study of 320 mg and 640 mg doses of Bacopa monnieri (CDRI 08) on multitasking stress reactivity and mood.

    PubMed

    Benson, Sarah; Downey, Luke A; Stough, Con; Wetherell, Mark; Zangara, Andrea; Scholey, Andrew

    2014-04-01

    Little research exists in humans concerning the anxiolytic, antidepressant, sedative, and adaptogenic actions the traditional Ayurvedic medicine Bacopa monnieri (BM) possesses in addition to its documented cognitive-enhancing effects. Preclinical work has identified a number of acute anxiolytic, nootropic, and adaptogenic effects of BM that may also co-occur in humans. The current double-blind, placebo-controlled cross-over study assessed the acute effects of a specific extract of BM (KeenMind® - CDRI 08) in normal healthy participants during completion of a multitasking framework (MTF). Seventeen healthy volunteers completed the MTF, at baseline, then 1 h and 2 h after consuming a placebo, 320 mg BM and 640 mg of BM. Treatments were separated by a 7-day washout with order determined by Latin Square. Outcome measures included cognitive outcomes from the MTF, with mood and salivary cortisol measured before and after each completion of the MTF. Change from baseline scores indicated positive cognitive effects, notably at both 1 h post and 2 h post BM consumption on the Letter Search and Stroop tasks, suggesting an earlier nootropic effect of BM than previously investigated. There were also some positive mood effects and reduction in cortisol levels, pointing to a physiological mechanism for stress reduction associated with BM consumption. It was concluded that acute BM supplementation produced some adaptogenic and nootropic effects that need to be replicated in a larger sample and in isolation from stressful cognitive tests in order to quantify the magnitude of these effects. The study was registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12612000834853). PMID:23788517

  18. Probiotic strain Lactobacillus plantarum 299v increases iron absorption from an iron-supplemented fruit drink: a double-isotope cross-over single-blind study in women of reproductive age.

    PubMed

    Hoppe, Michael; Önning, Gunilla; Berggren, Anna; Hulthén, Lena

    2015-10-28

    Iron deficiency is common, especially among young women. Adding probiotics to foods could be one way to increase iron absorption. The aim of this study was to test the hypothesis that non-haem iron absorption from a fruit drink is improved by adding Lactobacillus plantarum 299v (Lp299v). Iron absorption was studied in healthy women of reproductive age using a single-blind cross-over design in two trials applying the double-isotope (55Fe and 59Fe) technique. In Trial 1, iron absorption from a fruit drink containing 109 colony-forming units (CFU) Lp299v was compared with that from a control drink without Lp299v. Trial 2 had the same design but 1010 CFU were used. The test and control drinks contained approximately 5 mg of iron as ferrous lactate and were labelled with 59Fe (B) and 55Fe (A), respectively, and consumed on 4 consecutive days in the order AABB. Retention of the isotopes was measured with whole-body counting and in blood. Mean iron absorption from the drink containing 109 CFU Lp299v (28·6(sd 12·5) %) was significantly higher than from the control drink (18·5(sd 5·8) %), n 10, P<0·028). The fruit drink with 1010 CFU Lp299v gave a mean iron absorption of 29·1(sd 17·0) %, whereas the control drink gave an absorption of (20·1(sd 6·4) %) (n 11, P<0·080). The difference in iron absorption between the 109 CFU Lp299v and the 1010 CFU Lp299v drinks was not significant (P=0·941). In conclusion, intake of probiotics can increase iron absorption by approximately 50 % from a fruit drink having an already relatively high iron bioavailability.

  19. Effects of supplementing n-3 fatty acid enriched eggs and walnuts on cardiovascular disease risk markers in healthy free-living lacto-ovo-vegetarians: a randomized, crossover, free-living intervention study

    PubMed Central

    2014-01-01

    Background Plant and marine n-3 fatty acids (FA) may favorably modify select markers of cardiovascular disease risk. Whether supplementing the habitual diet of lacto-ovo-vegetarians (LOV) with walnuts (containing α-linolenic acid, ALA) and n-3 FA enriched eggs (containing primarily docosahexaenoic acid, DHA and ALA) would have equivalent effects on CVD risk factors is explored in this study. Methods In this study, 20 healthy free-living LOVs following their habitual diet were randomly assigned in a crossover design to receive one of three supplements: n-3 FA enriched egg (6/week), walnuts (28.4 g, 6/week) or a standard egg, 6/week (control) for 8 weeks each with 4-wk washout between treatments. Erythrocyte membrane fatty acids, serum lipids and inflammatory markers were measured at the end of each treatment. Results Dietary compliance was observed by an expected increase in erythrocyte membrane ALA following the walnut treatment and in DHA following the n-3 FA enriched egg treatment. Walnut treatment lowered serum triacylglycerol, total cholesterol and Apo B (p < 0.05) compared to the standard egg but not the n-3 FA enriched egg treatment. However, walnut treatment significantly reduced total: HDL cholesterol ratio compared to both egg treatments. There were no differences between treatments for any of the inflammatory markers. Conclusions For LOV, a direct source of DHA such as n-3 FA enriched eggs seems necessary to increase membrane levels of DHA. However for producing an overall favorable blood lipid profile, daily consumption of a handful of walnuts rich in ALA may be a preferred option for lacto-ovo vegetarian. PMID:24673793

  20. Spontaneous laser doppler flux distribution in ischemic ulcers and the effect of prostanoids: a crossover study comparing the acute action of prostaglandin E1 and iloprost vs saline.

    PubMed

    Gschwandtner, M E; Koppensteiner, R; Maca, T; Minar, E; Schneider, B; Schnürer, G; Ehringer, H

    1996-01-01

    The flux distribution within ischemic ulcers and adjacent skin and its change by prostanoids was investigated using laser Doppler flux scanning. A prostanoid-induced increase in ulcer flux could be a rationale for the improved wound healing. In a single-blind prospective study 18 patients received prostaglandin E1 (PGE1) (333.3 ng/min.), iloprost (41.7 ng/min final dose), and 0.9% saline in a randomized order. The average laser Doppler flux within the ulcer (LFU, x +/- SEM, arbitrary units) or in the adjacent skin (LFS) was evaluated before and 30, 60, 90, and 120 min after prostanoid/saline infusion. LFU increased with PGE1 from 2.30 +/- 0.27 to 3.08 +/- 0.31 (+33.9%; P < 0.001) and with iloprost from 2.37 +/- 0.26 to 3.03 +/- 0.27 (+27.8%; P < 0.001) after 120 min, respectively. Saline did not change LFU significantly: 2.19 +/- 0.18 vs 2.55 +/- 0.26 (+16.4%; P > 0.05). Simultaneously, LFS was not significantly changed when pretreatment values were compared with mean flux at 120 min: PGE1 2.13 +/- 0.27 vs 2.54 +/- 0.34, iloprost 2.03 +/- 0.26 vs 1.94 +/- 0.21, and saline 1.74 +/- 0.27 vs 1.92 +/- 0.30 (P > 0.05, each), respectively. The laser Doppler flux scanning technique might be a tool to study the distribution of laser Doppler flux within ischemic ulcers. This might be useful to study the physiological or pathophysiological control of flux within ischemic ulcers as well as possible therapeutic approaches. PMID:8812752

  1. Comparison of the effect of naproxen, etodolac and diclofenac on postoperative sequels following third molar surgery: A randomised, double-blind, crossover study

    PubMed Central

    Akbulut, Nihat; Atakan, Cemal; Çölok, Gülümser

    2014-01-01

    Objectives: To compare the three non-steroidal anti-inflammatory agents (NSAIDs) diclofenac potassium, etodolac and naproxen sodium in relation to pain, swelling and trismus following impacted third molar surgery. Study Design: The study was a randomized and a double-blinded study which included 42 healthy young individuals with impacted third molars and bone retention. Patients were randomly assigned to 3 groups (n: 14) to which diclofenac potassium, naproxen sodium and etodolac were administered orally an hour before the operation. Impacted third molars were surgically extracted with local anaesthesia. Visual analog scales (VAS) were used to assess the pain in the 6th, 12th hours and on the 1st, 2nd, 3rd, 5th, and 7th days postoperatively. Swelling was evaluated using ultrasound (US) and mouth opening (trismus) was measured with a composing stick pre and post operatively on the 2nd and 7th days respectively. Results: Regarding pain alleviation, diclofenac potassium was better than naproxen sodium and naproxen sodium was better than etodolac but these differences were not statistically significant. US measurements showed that the swelling on postoperative 2nd day was significantly lowest with diclofenac potassium as compared to others (p= 0.027) while naproxen sodium and etodolac acted similarly (p=0.747). No difference was noted regarding trismus in any of the groups. Conclusions: NSAIDs (diclofenac, naproxen and etodolac) are somehow similarly effective for controlling pain and trismus following extraction of mandibular third molars but diclofenac potassium surpasses others in reduction of swelling. Key words:Diclofenac potassium, naproxen sodium, etodolac, impacted third molar surgery, pain, swelling, trismus. PMID:24316711

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

    PubMed

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

    2013-11-01

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

  3. Developing and Evaluating Medical Humanities Problem-Based Learning Classes Facilitated by the Teaching Assistants Majored in the Liberal Arts: A Longitudinal Crossover Study.

    PubMed

    Tseng, Fen-Yu; Shieh, Jeng-Yi; Kao, Tze-Wah; Wu, Chau-Chung; Chu, Tzong-Shinn; Chen, Yen-Yuan

    2016-02-01

    Although medical humanities courses taught by teachers from nonmedical backgrounds are not unusual now, few studies have compared the outcome of medical humanities courses facilitated by physicians to that by teaching assistants majored in the liberal arts. The objectives of this study were to (1) analyze the satisfaction of medical students with medical humanities problem-based learning (PBL) classes facilitated by nonmedical teaching assistants (TAF) majored in the liberal arts, and those facilitated by the attending physicians (APF) and (2) examine the satisfaction of medical students with clinical medicine-related and clinical medicine-unrelated medical humanities PBL classes.A total of 123 medical students, randomly assigned to 16 groups, participated in this study. There were 16 classes in the course: 8 of them were TAF classes; and the others were APF classes. Each week, each group rotated from 1 subject of the 16 subjects of PBL to another subject. All of the 16 groups went through all the 16 subjects in the 2013 spring semester. We examined the medical students' satisfaction with each class, based on a rating score collected after each class was completed, using a scale from 0 (the lowest satisfaction) to 100 (the highest satisfaction). We also conducted multivariate linear regression analysis to examine the association between the independent variables and the students' satisfaction.Medical students were more satisfied with the TAF (91.35 ± 7.75) medical humanities PBL classes than APF (90.40 ± 8.42) medical humanities PBL classes (P = 0.01). Moreover, medical students were more satisfied with the clinical medicine-unrelated topics (92.00 ± 7.10) than the clinical medicine-related topics (90.36 ± 7.99) in the medical humanities PBL course (P = 0.01).This medical humanities PBL course, including nonmedical subjects and topics, and nonmedical teaching assistants from the liberal arts as class facilitators, was satisfactory. This

  4. Does switching to a tobacco-free waterpipe product reduce toxicant intake? A crossover study comparing CO, NO, PAH, volatile aldehydes, "tar" and nicotine yields.

    PubMed

    Shihadeh, Alan; Salman, Rola; Jaroudi, Ezzat; Saliba, Najat; Sepetdjian, Elizabeth; Blank, Melissa D; Cobb, Caroline O; Eissenberg, Thomas

    2012-05-01

    Waterpipe (hookah, narghile, shisha) use has become a global phenomenon, with numerous product variations. One variation is a class of products marketed as "tobacco-free" alternatives for the "health conscious user". In this study toxicant yields from waterpipes smoked using conventional tobacco-based and tobacco-free preparations were compared. A human-mimic waterpipe smoking machine was used to replicate the puffing sequences of 31 human participants who completed two double-blind ad libitum smoking sessions in a controlled clinical setting: once with a tobacco-based product of their choosing and once with a flavor-matched tobacco-free product. Outcome measures included yields of carbon monoxide, nitric oxide, volatile aldehydes, nicotine, tar, and polycyclic aromatic hydrocarbons. Smoke from both waterpipe preparations contained substantial quantities of toxicants. Nicotine yield was the only outcome that differed significantly between preparations. These findings contradict advertising messages that "herbal" waterpipe products are a healthy alternative to tobacco products. PMID:22406330

  5. A counterbalanced cross-over study of the effects of visual, auditory and no feedback on performance measures in a simulated cardiopulmonary resuscitation

    PubMed Central

    2011-01-01

    Background Previous research has demonstrated that trained rescuers have difficulties achieving and maintaining the correct depth and rate of chest compressions during both in and out of hospital cardiopulmonary resuscitation (CPR). Feedback on rate and depth mitigate decline in performance quality but not completely with the residual performance decline attributed to rescuer fatigue. The purpose of this study was to examine the effects of feedback (none, auditory only and visual only) on the quality of CPR and rescuer fatigue. Methods Fifteen female volunteers performed 10 minutes of 30:2 CPR in each of three feedback conditions: none, auditory only, and visual only. Visual feedback was displayed continuously in graphic form. Auditory feedback was error correcting and provided by a voice assisted CPR manikin. CPR quality measures were collected using SkillReporter® software. Blood lactate (mmol/dl) and perceived exertion served as indices of fatigue. One-way and two way repeated measures analyses of variance were used with alpha set a priori at 0.05. Results Visual feedback yielded a greater percentage of correct compressions (78.1 ± 8.2%) than did auditory (65.4 ± 7.6%) or no feedback (44.5 ± 8.1%). Compression rate with auditory feedback (87.9 ± 0.5 compressions per minute) was less than it was with both visual and no feedback (p < 0.05). CPR performed with no feedback (39.2 ± 0.5 mm) yielded a shallower average depth of compression and a lower percentage (55 ± 8.9%) of compressions within the accepted 38-50 mm range than did auditory or visual feedback (p < 0.05). The duty cycle for auditory feedback (39.4 ± 1.6%) was less than it was with no feedback (p < 0.05). Auditory feedback produced lower lactate concentrations than did visual feedback (p < 0.05) but there were no differences in perceived exertion. Conclusions In this study feedback mitigated the negative effects of fatigue on CPR performance and visual feedback yielded better CPR performance

  6. Changes of Plantar Pressure and Gait Parameters in Children with Mild Cerebral Palsy Who Used a Customized External Strap Orthosis: A Crossover Study

    PubMed Central

    Chang, Wen-Dien; Chang, Nai-Jen; Lin, Hung-Yu; Lai, Ping-Tung

    2015-01-01

    Toe-in gait and crouch gait can make children with mild cerebral palsy fall and suffer improper balance during walking or ambulation training. A customized external strap orthosis for correcting leg alignment was used to resolve this problem. The purpose of this study was to research the immediate effects while wearing the customized external strap orthosis. Pressure platform was used to assess the plantar pressure through static and dynamic assessments and to record the changes in path of pressure trajectory. Motion image analysis system was used to record the gait parameters, which included gait speed, stride length, and cadence. The influence of both wearing and removing the orthosis on the dominant leg of children with mild cerebral palsy was analyzed. Nine children with mild cerebral palsy, who all had a dominant right leg, were recruited. After wearing the orthosis, all gait parameters improved, and foot motion changed in the stance phase of the gait cycle. The path of pressure trajectory closing to the midline was also observed during dynamic assessment. Changes in plantar pressure and path of pressure trajectory were observed and the orthosis device could provide immediate assistance to correct the leg alignment and improve the gait performance in children with mild cerebral palsy. PMID:26640796

  7. Effect of yogurt and pH equivalent lemon juice on salivary flow rate in healthy volunteers – An experimental crossover study

    PubMed Central

    Murugesh, Jeevitha; Annigeri, Rajeshwari G.; Raheel, Syed Ahmed; Azzeghaiby, Saleh; Alshehri, Mohammad; Kujan, Omar

    2015-01-01

    Background Xerostomia is a common clinical problem, and different medications have been tried in its management. In the present study, routine dietary products are used to assess their effect on salivary flow. Aim To assess the efficacy of yogurt and lemon juice on increase in salivation and its comparison with that of unstimulated saliva. Materials and Methods A total of 40 volunteers (aged 19–48) were selected. The pH of yogurt was calculated, and equivalent pH lemon juice was prepared. First, normal resting saliva was collected as baseline followed by every 1 min for 5 min. Patients were given lemon juice or yogurt and then crossed over to the other group to assess the impact of the stimulants on salivary flow from 1 to 5 min. Results The results were analyzed statistically. Comparisons between baseline saliva secretion and that by yogurt and lemon juice (using the ANOVA test) showed that there was a significant increase after treatment at the end of the experiment for both yogurt and lemon juice. However, yogurt showed a significant increase in saliva secretion compared to baseline than lemon juice. Conclusions Our findings suggest that yogurt is a potential candidate for the treatment of dry mouth. PMID:26767120

  8. Changes of Plantar Pressure and Gait Parameters in Children with Mild Cerebral Palsy Who Used a Customized External Strap Orthosis: A Crossover Study.

    PubMed

    Chang, Wen-Dien; Chang, Nai-Jen; Lin, Hung-Yu; Lai, Ping-Tung

    2015-01-01

    Toe-in gait and crouch gait can make children with mild cerebral palsy fall and suffer improper balance during walking or ambulation training. A customized external strap orthosis for correcting leg alignment was used to resolve this problem. The purpose of this study was to research the immediate effects while wearing the customized external strap orthosis. Pressure platform was used to assess the plantar pressure through static and dynamic assessments and to record the changes in path of pressure trajectory. Motion image analysis system was used to record the gait parameters, which included gait speed, stride length, and cadence. The influence of both wearing and removing the orthosis on the dominant leg of children with mild cerebral palsy was analyzed. Nine children with mild cerebral palsy, who all had a dominant right leg, were recruited. After wearing the orthosis, all gait parameters improved, and foot motion changed in the stance phase of the gait cycle. The path of pressure trajectory closing to the midline was also observed during dynamic assessment. Changes in plantar pressure and path of pressure trajectory were observed and the orthosis device could provide immediate assistance to correct the leg alignment and improve the gait performance in children with mild cerebral palsy.

  9. Does switching to a tobacco-free waterpipe product reduce toxicant intake? A crossover study comparing CO, NO, PAH, volatile aldehydes, tar and nicotine yields

    PubMed Central

    Shihadeh, Alan; Salman, Rola; Jaroudi, Ezzat; Saliba, Najat; Sepetdjian, Elizabeth; Blank, Melissa D.; Cobb, Caroline O.; Eissenberg, Thomas

    2012-01-01

    Waterpipe (hookah, narghile, shisha) use has become a global phenomenon, with numerous product variations. One variation is a class of products marketed as “tobacco-free” alternatives for the “health conscious user”. In this study toxicant yields from waterpipes smoked using conventional tobacco-based and tobacco-free preparations were compared. A human-mimic waterpipe smoking machine was used to replicate the puffing sequences of 31 human participants who completed two double-blind ad libitum smoking sessions in a controlled clinical setting: once with a tobacco-based product of their choosing and once with a flavor-matched tobacco-free product. Outcome measures included yields of carbon monoxide, nitric oxide, volatile aldehydes, nicotine, tar, and polycyclic aromatic hydrocarbons. Smoke from both waterpipe preparations contained substantial quantities of toxicants. Nicotine yield was the only outcome that differed significantly between preparations. These findings contradict advertising messages that “herbal” waterpipe products are a healthy alternative to tobacco products. PMID:22406330

  10. Theoretical study of thermal spin transition between the singlet state and the quintet state in the [Fe(2-picolylamine)(3)](2+) spin crossover system.

    PubMed

    Shiota, Yoshihito; Sato, Daisuke; Juhász, Gergely; Yoshizawa, Kazunari

    2010-05-13

    The spin transition between the low-spin singlet state and the high-spin quintet state in the [Fe(2-pic)(3)](2+) (2-pic: 2-picolylamine) complex is studied by using density functional theory (DFT) calculations. After careful comparison of density functionals BLYP, B3LYP, and B3LYP* (which has 15% Hartree-Fock exchange compared with 20% for B3LYP), we concluded that the spin-state splitting can be accurately reproduced by using the B3LYP* functional. The potential energy surfaces along minimum energy pathways of the three spin states were calculated at the B3LYP*/6-311+G** level of theory to find minimum energy crossing points (MECPs). The MECPs between the singlet and quintet states (SQ(M)) were found (E(SQ) = 6.8 kcal/mol), as well as the MECPs between the triplet and singlet states (ST(M), E(ST) = 12.9 kcal/mol) and the triplet and quintet states (TQ(M), E(TQ) = 12.8 kcal/mol). Although the distortion leading to SQ(M) from the singlet equilibrium geometry is mainly a symmetric expansion of the Fe-N bonds, the distortions leading to ST(M) and SQ(M) are asymmetric. Normal mode analysis demonstrates that these geometrical distortions contain a combination of several low-frequency normal modes, and therefore, these modes play a significant role in the intersystem crossing via the crossing seam. PMID:20405889

  11. Consumption of green coffee reduces blood pressure and body composition by influencing 11β-HSD1 enzyme activity in healthy individuals: a pilot crossover study using green and black coffee.

    PubMed

    Revuelta-Iniesta, R; Al-Dujaili, E A S

    2014-01-01

    Dietary polyphenols may have a protective role against the development of CVD. Thus, we aimed to investigate the effects of green coffee (GC), rich in chlorogenic acid, and black coffee (BC) on cardiovascular markers. A randomised pilot crossover study was performed on healthy subjects who consumed both coffees for 2 weeks. We measured anthropometry, blood pressure, and arterial elasticity after each intervention and collected urine samples to monitor antioxidant capacity. Free cortisol and cortisone levels were obtained from urine and analysed by specific ELISA methods. Systolic blood pressure (P = 0.018) and arterial elasticity (P = 0.001) were significantly reduced after GC. BMI (P = 0.04 for BC; P = 0.01 for GC) and abdominal fat (P = 0.01 for BC; P = 0.009 for GC) were also significantly reduced with no changes in energy intake. Urinary free cortisol was significantly reduced from 125.6 ± 85.9 nmol/day to 76.0 ± 54.9 nmol/day following GC and increased to 132.1 ± 89.1 nmol/day after BC. Urinary free cortisone increased by 18% following BC and 9% following GC (nonsignificant). Cortisol/cortisone ratio (indicating 11β-HSD1 activity) was reduced after GC (from 3.5 ± 1.9 to 1.7 ± 1.04, P = 0.002). This suggests that GC can play a role in reducing cardiovascular risk factors. Further research including hypertensive and overweight individuals will now be justified to clarify whether GC could have a therapeutic role in CVD.

  12. Short-term effect of strontium- and zinc-containing toothpastes and mouthrinses on volatile sulphur compounds in morning breath: a randomized, double-blind, cross-over clinical study.

    PubMed

    Soares, Léo G; Jonski, Grazyna; Tinoco, Eduardo M B; Young, Alix

    2015-04-01

    Zinc (Zn) reduces the formation of volatile sulphur compounds (VSCs) associated with oral malodour. Although strontium (Sr) is included in some products for reducing dental hypersensitivity, it may also have anti-halitosis properties. This randomized, double-blind, cross-over clinical study compared the anti-VSC effect of brushing with commercial toothpastes and rinses containing Zn and Sr. The volunteers (n = 30) either brushed/rinsed with/without tongue brushing using Zn-containing toothpaste/rinse, Sr-containing toothpaste/rinse, or placebo (control). Volatile sulphur compounds [hydrogen sulphide (H2 S) and methyl mercaptan (CH3 SH)] were measured, in morning breath, using gas chromatography. The anti-VSC effects of the test toothpastes and test rinses were significantly better than the anti-VSC effects of the respective controls. Toothbrushing with test toothpastes gave median reductions, compared with the control, of 70% for H2 S and 55-57% for CH3 SH. Rinsing with the Sr- and Zn-containing solutions had the same anti-VSC effect as toothbrushing and tooth- and tongue brushing with the Sr- and Zn-containing toothpastes. Zinc-containing rinse resulted in a significantly higher median salivary level of Zn compared with brushing with Zn-containing toothpaste, although this effect did not correlate with the anti-VSC effect. It can be concluded that the Sr- and Zn-containing toothpastes and the Zn- and Sr-containing rinses, when used in the evening, are equally effective in reducing morning-breath VSCs the following day. PMID:25689513

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

    PubMed

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

    2016-01-01

    Dietary recommendations suggest decreased consumption of SFA to minimise CVD risk; however, not all foods rich in SFA are equivalent. To evaluate the effects of SFA in a dairy food matrix, as Cheddar cheese, v. SFA from a vegan-alternative test meal on postprandial inflammatory markers, a randomised controlled cross-over trial was conducted in twenty overweight or obese adults with metabolic abnormalities. Individuals consumed two isoenergetic high-fat mixed meals separated by a 1- to 2-week washout period. Serum was collected at baseline, and at 1, 3 and 6 h postprandially and analysed for inflammatory markers (IL-6, IL-8, IL-10, IL-17, IL-18, TNFα, monocyte chemotactic protein-1 (MCP-1)), acute-phase proteins C-reactive protein (CRP) and serum amyloid-A (SAA), cellular adhesion molecules and blood lipids, glucose and insulin. Following both high-fat test meals, postprandial TAG concentrations rose steadily (P < 0·05) without a decrease by 6 h. The incremental AUC (iAUC) for CRP was significantly lower (P < 0·05) in response to the cheese compared with the vegan-alternative test meal. A treatment effect was not observed for any other inflammatory markers; however, for both test meals, multiple markers significantly changed from baseline over the 6 h postprandial period (IL-6, IL-8, IL-18, TNFα, MCP-1, SAA). Saturated fat in the form of a cheese matrix reduced the iAUC for CRP compared with a vegan-alternative test meal during the postprandial 6 h period. The study is registered at clinicaltrials.gov under NCT01803633. PMID:27313852

  14. β2-1 Fructan supplementation alters host immune responses in a manner consistent with increased exposure to microbial components: results from a double-blinded, randomised, cross-over study in healthy adults.

    PubMed

    Clarke, Sandra T; Green-Johnson, Julia M; Brooks, Stephen P J; Ramdath, D Dan; Bercik, Premysl; Avila, Christian; Inglis, G Douglas; Green, Judy; Yanke, L Jay; Selinger, L Brent; Kalmokoff, Martin

    2016-05-28

    β2-1 Fructans are purported to improve health by stimulating growth of colonic bifidobacteria, increasing host resistance to pathogens and stimulating the immune system. However, in healthy adults, the benefits of supplementation remain undefined. Adults (thirteen men, seventeen women) participated in a double-blinded, placebo-controlled, randomised, cross-over study consisting of two 28-d treatments separated by a 14-d washout period. Subjects' regular diets were supplemented with β2-1 fructan or placebo (maltodextrin) at 3×5 g/d. Fasting blood and 1-d faecal collections were obtained at the beginning and at the end of each phase. Blood was analysed for clinical, biochemical and immunological variables. Determinations of well-being and general health, gastrointestinal (GI) symptoms, regularity, faecal SCFA content, residual faecal β2-1 fructans and faecal bifidobacteria content were undertaken. β2-1 Fructan supplementation had no effect on blood lipid or cholesterol concentrations or on circulating lymphocyte and macrophage numbers, but significantly increased serum lipopolysaccharide, faecal SCFA, faecal bifidobacteria and indigestion. With respect to immune function, β2-1 fructan supplementation increased serum IL-4, circulating percentages of CD282+/TLR2+ myeloid dendritic cells and ex vivo responsiveness to a toll-like receptor 2 agonist. β2-1 Fructans also decreased serum IL-10, but did not affect C-reactive protein or serum/faecal Ig concentrations. No differences in host well-being were associated with either treatment, although the self-reported incidence of GI symptoms and headaches increased during the β2-1 fructan phase. Although β2-1 fructan supplementation increased faecal bifidobacteria, this change was not directly related to any of the determined host parameters.

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

    PubMed

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

    2016-01-01

    Dietary recommendations suggest decreased consumption of SFA to minimise CVD risk; however, not all foods rich in SFA are equivalent. To evaluate the effects of SFA in a dairy food matrix, as Cheddar cheese, v. SFA from a vegan-alternative test meal on postprandial inflammatory markers, a randomised controlled cross-over trial was conducted in twenty overweight or obese adults with metabolic abnormalities. Individuals consumed two isoenergetic high-fat mixed meals separated by a 1- to 2-week washout period. Serum was collected at baseline, and at 1, 3 and 6 h postprandially and analysed for inflammatory markers (IL-6, IL-8, IL-10, IL-17, IL-18, TNFα, monocyte chemotactic protein-1 (MCP-1)), acute-phase proteins C-reactive protein (CRP) and serum amyloid-A (SAA), cellular adhesion molecules and blood lipids, glucose and insulin. Following both high-fat test meals, postprandial TAG concentrations rose steadily (P < 0·05) without a decrease by 6 h. The incremental AUC (iAUC) for CRP was significantly lower (P < 0·05) in response to the cheese compared with the vegan-alternative test meal. A treatment effect was not observed for any other inflammatory markers; however, for both test meals, multiple markers significantly changed from baseline over the 6 h postprandial period (IL-6, IL-8, IL-18, TNFα, MCP-1, SAA). Saturated fat in the form of a cheese matrix reduced the iAUC for CRP compared with a vegan-alternative test meal during the postprandial 6 h period. The study is registered at clinicaltrials.gov under NCT01803633.

  16. Short-term effect of strontium- and zinc-containing toothpastes and mouthrinses on volatile sulphur compounds in morning breath: a randomized, double-blind, cross-over clinical study.

    PubMed

    Soares, Léo G; Jonski, Grazyna; Tinoco, Eduardo M B; Young, Alix

    2015-04-01

    Zinc (Zn) reduces the formation of volatile sulphur compounds (VSCs) associated with oral malodour. Although strontium (Sr) is included in some products for reducing dental hypersensitivity, it may also have anti-halitosis properties. This randomized, double-blind, cross-over clinical study compared the anti-VSC effect of brushing with commercial toothpastes and rinses containing Zn and Sr. The volunteers (n = 30) either brushed/rinsed with/without tongue brushing using Zn-containing toothpaste/rinse, Sr-containing toothpaste/rinse, or placebo (control). Volatile sulphur compounds [hydrogen sulphide (H2 S) and methyl mercaptan (CH3 SH)] were measured, in morning breath, using gas chromatography. The anti-VSC effects of the test toothpastes and test rinses were significantly better than the anti-VSC effects of the respective controls. Toothbrushing with test toothpastes gave median reductions, compared with the control, of 70% for H2 S and 55-57% for CH3 SH. Rinsing with the Sr- and Zn-containing solutions had the same anti-VSC effect as toothbrushing and tooth- and tongue brushing with the Sr- and Zn-containing toothpastes. Zinc-containing rinse resulted in a significantly higher median salivary level of Zn compared with brushing with Zn-containing toothpaste, although this effect did not correlate with the anti-VSC effect. It can be concluded that the Sr- and Zn-containing toothpastes and the Zn- and Sr-containing rinses, when used in the evening, are equally effective in reducing morning-breath VSCs the following day.

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

    PubMed Central

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

    2015-01-01

    The effects of olive oil phenolic compounds (PCs) on HDL proteome, with respect to new aspects of cardioprotective properties, are still unknown. The aim of this study was to assess the impact on the HDL protein cargo of the intake of virgin olive oil (VOO) and two functional VOOs, enriched with their own PCs (FVOO) or complemented with thyme PCs (FVOOT), in hypercholesterolemic subjects. Eligible volunteers were recruited from the IMIM-Hospital del Mar Medical Research Institute (Spain) from April 2012 to September 2012. Thirty-three hypercholesterolemic participants (total cholesterol >200mg/dL; 19 men and 14 women; aged 35 to 80 years) were randomized in the double-blind, controlled, cross-over VOHF clinical trial. The subjects received for 3 weeks 25 mL/day of: VOO, FVOO, or FVOOT. Using a quantitative proteomics approach, 127 HDL-associated proteins were identified. Among these, 15 were commonly differently expressed after the three VOO interventions compared to baseline, with specific changes observed for each intervention. The 15 common proteins were mainly involved in the following pathways: LXR/RXR activation, acute phase response, and atherosclerosis. The three VOOs were well tolerated by all participants. Consumption of VOO, or phenol-enriched VOOs, has an impact on the HDL proteome in a cardioprotective mode by up-regulating proteins related to cholesterol homeostasis, protection against oxidation and blood coagulation while down-regulating proteins implicated in acute-phase response, lipid transport, and immune response. The common observed protein expression modifications after the three VOOs indicate a major matrix effect. Trial Registration International Standard Randomized Controlled Trials ISRCTN77500181. PMID:26061039

  18. β2-1 Fructan supplementation alters host immune responses in a manner consistent with increased exposure to microbial components: results from a double-blinded, randomised, cross-over study in healthy adults.

    PubMed

    Clarke, Sandra T; Green-Johnson, Julia M; Brooks, Stephen P J; Ramdath, D Dan; Bercik, Premysl; Avila, Christian; Inglis, G Douglas; Green, Judy; Yanke, L Jay; Selinger, L Brent; Kalmokoff, Martin

    2016-05-28

    β2-1 Fructans are purported to improve health by stimulating growth of colonic bifidobacteria, increasing host resistance to pathogens and stimulating the immune system. However, in healthy adults, the benefits of supplementation remain undefined. Adults (thirteen men, seventeen women) participated in a double-blinded, placebo-controlled, randomised, cross-over study consisting of two 28-d treatments separated by a 14-d washout period. Subjects' regular diets were supplemented with β2-1 fructan or placebo (maltodextrin) at 3×5 g/d. Fasting blood and 1-d faecal collections were obtained at the beginning and at the end of each phase. Blood was analysed for clinical, biochemical and immunological variables. Determinations of well-being and general health, gastrointestinal (GI) symptoms, regularity, faecal SCFA content, residual faecal β2-1 fructans and faecal bifidobacteria content were undertaken. β2-1 Fructan supplementation had no effect on blood lipid or cholesterol concentrations or on circulating lymphocyte and macrophage numbers, but significantly increased serum lipopolysaccharide, faecal SCFA, faecal bifidobacteria and indigestion. With respect to immune function, β2-1 fructan supplementation increased serum IL-4, circulating percentages of CD282+/TLR2+ myeloid dendritic cells and ex vivo responsiveness to a toll-like receptor 2 agonist. β2-1 Fructans also decreased serum IL-10, but did not affect C-reactive protein or serum/faecal Ig concentrations. No differences in host well-being were associated with either treatment, although the self-reported incidence of GI symptoms and headaches increased during the β2-1 fructan phase. Although β2-1 fructan supplementation increased faecal bifidobacteria, this change was not directly related to any of the determined host parameters. PMID:26987626

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

    PubMed Central

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

    2006-01-01

    This is the second, conclusive part of the clinical study on clinical responses of early-postmenopausal women to standardized doses of pre-Gelatinized Organic Maca (Maca-GO). Total of 34 Caucasian women volunteers participated in a double-blind, randomized, four months outpatient crossover configuration Trial. After fulfilling the criteria of being early-postmenopausal: blood Estrogen (E2<40 pg/ml) and Follicle Stimulating Hormone (FSH>30 IU/ml) at admission, they were randomly allocated to Placebo (P) and Maca-GO (M) treatments (2 groups of 11 participants each). Two 500 mg vegetable hard gel capsules with Maca-GO or Placebo powder were self-administered twice daily with meals (total 2 g/day). At admission and follow-up monthly intervals, body mass index (BMI), blood pressure, levels of gonadal, pituitary, thyroid and adrenal hormones, lipids and key minerals were measured. Bone markers were determined after four months M and P use in 12 participants. Menopausal symptoms were assessed according to Greene’s Score (GMS) and Kupperman’s Index (KMI). Data were analyzed using multivariate technique on blocs of monthly. Results and canonical variate technique was applied to GMS and KMI matrices. Two months application of Maca-GO stimulated (P<0.05) production of E2, suppressed (P<0.05) blood FSH, Thyroid (T3) and Adrenocorticotropic hormones, Cortisol, and BMI, increased (P<0.05) low density lipoproteins, blood Iron and alleviated (P<0.001) menopausal symptoms. Maca-GO noticeably increased bone density markers. In conclusion, Maca-GO applied to early-postmenopausal women (i) acted as a toner of hormonal processes along the Hypothalamus-Pituitary-Ovarian axis, (ii) balanced hormone levels and (iii) relieved symptoms of menopausal discomfort, (hot flushes and night sweating in particular), thus, (iv) exhibited a distinctive function peculiar to adaptogens, providing an alternative non-hormonal plant option to reduce dependence on hormone therapy programs (HRT). PMID

  20. Effects of calcium channel blockers on glucose tolerance, inflammatory state, and circulating progenitor cells in non-diabetic patients with essential hypertension: a comparative study between Azelnidipine and amlodipine on glucose tolerance and endothelial function - a crossover trial (AGENT)

    PubMed Central

    2011-01-01

    Background Hypertension is associated with impaired glucose tolerance and insulin resistance. Medical treatment that interferes with various steps in the renin-angiotensin system improves glucose tolerance and insulin resistance. However, it remains unclear if long-acting calcium channel blockers (CCBs) such as azelnidipine and amlodipine affect glucose tolerance and insulin resistance in clinical practice. Methods Seventeen non-diabetic patients with essential hypertension who had controlled blood pressure levels using amlodipine (5 mg/day) were enrolled in this study. After randomization, either azelnidipine (16 mg/day) or amlodipine (5 mg/day) was administered in a crossover design for 12-weeks. At baseline and the end of each CCB therapy, samples of blood and urine were collected and 75 g oral glucose tolerance test (OGTT) was performed. In addition, hematopoietic progenitor cells (HPCs) were measured at each point by flow cytometry and endothelial functions were measured by fingertip pulse amplitude tonometry using EndoPAT. Results Although blood pressure levels were identical after each CCB treatment, the heart rate significantly decreased after azelnidipine administration than that after amlodipine administration (P < 0.005). Compared with amlodipine administration, azelnidipine significantly decreased levels of glucose and insulin 120 min after the 75 g OGTT (both P < 0.05). Serum levels of high-sensitivity C-reactive protein (P = 0.067) and interleukin-6 (P = 0.035) were decreased. Although endothelial functions were not different between the two medication groups, the number of circulating HPCs was significantly increased after azelnidipine administration (P = 0.016). Conclusions These results suggest that azelnidipine treatment may have beneficial effects on glucose tolerance, insulin sensitivity, the inflammatory state, and number of circulating progenitor cells in non-diabetic patients with essential hypertension. PMID:21906391

  1. Chest compression quality, exercise intensity, and energy expenditure during cardiopulmonary resuscitation using compression-to-ventilation ratios of 15:1 or 30:2 or chest compression only: a randomized, crossover manikin study

    PubMed Central

    Kwak, Se-Jung; Kim, Young-Min; Baek, Hee Jin; Kim, Se Hong; Yim, Hyeon Woo

    2016-01-01

    Objective Our aim was to compare the compression quality, exercise intensity, and energy expenditure in 5-minute single-rescuer cardiopulmonary resuscitation (CPR) using 15:1 or 30:2 compression-to-ventilation (C:V) ratios or chest compression only (CCO). Methods This was a randomized, crossover manikin study. Medical students were randomized to perform either type of CPR and do the others with intervals of at least 1 day. We measured compression quality, ratings of perceived exertion (RPE) score, heart rate, maximal oxygen uptake, and energy expenditure during CPR. Results Forty-seven students were recruited. Mean compression rates did not differ between the 3 groups. However, the mean percentage of adequate compressions in the CCO group was significantly lower than that of the 15:1 or 30:2 group (31.2±30.3% vs. 55.1±37.5% vs. 54.0±36.9%, respectively; P<0.001) and the difference occurred within the first minute. The RPE score in each minute and heart rate change in the CCO group was significantly higher than those of the C:V ratio groups. There was no significant difference in maximal oxygen uptake between the 3 groups. Energy expenditure in the CCO group was relatively lower than that of the 2 C:V ratio groups. Conclusion CPR using a 15:1 C:V ratio may provide a compression quality and exercise intensity comparable to those obtained using a 30:2 C:V ratio. An earlier decrease in compression quality and increase in RPE and heart rate could be produced by CCO CPR compared with 15:1 or 30:2 C:V ratios with relatively lower oxygen uptake and energy expenditure. PMID:27752633

  2. Protein-carbohydrate supplements improve muscle protein balance in muscular dystrophy patients after endurance exercise: a placebo-controlled crossover study.

    PubMed

    Andersen, Grete; Ørngreen, Mette C; Preisler, Nicolai; Jeppesen, Tina D; Krag, Thomas O; Hauerslev, Simon; van Hall, Gerrit; Vissing, John

    2015-01-15

    In healthy individuals, postexercise protein supplementation increases muscle protein anabolism. In patients with muscular dystrophies, aerobic exercise improves muscle function, but the effect of exercise on muscle protein balance is unknown. Therefore, we investigated 1) muscle protein balance before, during, and after exercise and 2) the effect of postexercise protein-carbohydrate supplementation on muscle protein balance in patients with muscular dystrophies. In 17 patients [7 women and 10 men, aged 33 ± 11 yr (18-52), body mass index: 22 ± 3 kg/m(2) (16-26)] and 8 healthy matched controls [3 women and 5 men, age 33 ± 13 years (19-54), body mass index: 23 ± 3 kg/m(2) (19-27)], muscle protein synthesis, breakdown, and fractional synthesis rates (FSR) were measured across the leg using tracer dilution methodology on two occasions, with and without oral postexercise protein-carbohydrate supplementation. In patients, muscle protein breakdown increased in the recovery period (11 ± 1 μmol phenylalanine/min) vs. rest (8 ± 1 μmol phenylalanine/min, P = 0.02), enhancing net muscle protein loss. In contrast, postexercise protein-carbohydrate supplementation reduced protein breakdown, abolished net muscle protein loss, and increased the muscle FSR in patients (0.04 to 0.06%/h; P = 0.03). In conclusion, postexercise protein-carbohydrate supplementation reduces skeletal mixed-muscle protein breakdown, enhances FSR, resulting in a reduced net muscle loss in patients with muscular dystrophies. The findings suggest that postexercise protein-carbohydrate supplementation could be an important add-on to exercise training therapy in muscular dystrophies, and long-term studies of postexercise protein-carbohydrate supplementation are warranted in these conditions.

  3. Adaptation and validation of the Portuguese version of the Lithium Knowledge Test (LKT) of bipolar patients treated with lithium: cross-over study

    PubMed Central

    2006-01-01

    Objective Adherence problems are a common feature among bipolar patients. A recent study showed that lithium knowledge was the main difference between adherent and non adherents bipolar patients. The Lithium Knowledge Test (LKT), a brief questionnaire, was developed as a means of identifying aspects of patients' practical and pharmacological knowledge which are important if therapy is to be safe and effective. The original English version is validated in psychiatric population, but a validated Portuguese one is not yet available. Methods One hundred six patients selected were diagnosed with bipolar disorder (I or II) according to DSM-IV criteria and had to be on lithium treatment for at least one month. The LKT was administered on only one occasion. We analysed the internal consis tency, concurrent validity, sensitivity and specificity of the LKT for the detection of the knowledge about lithium treatment of bipolar patients. Results The internal consistency, evaluated by Cronbach's alpha was 0.596. The mean of total score LKT by bipolar patients was 9.0 (SD: 0.75) for men and 8.74 (SD: 0.44) for women. Concurrent validity based on plasma lithium concentration showed a significant correlation between the total LKT score and plasma lithium (r = 0,232; p = 0.020). The sensitivity was 84% and specificity was 81%. Conclusion LKT is a rapid, reliable instrument which appears to be as effective as a lengthier standard interview with a lithium clinic doctor, and which has a high level of acceptability to lithium patients. We found that the psychometric assessment of the Portuguese version of LKT showed good internal consistency, sensitivity and specificity. PMID:17147815

  4. Impact of traffic-related air pollution on acute changes in cardiac autonomic modulation during rest and physical activity: a cross-over study.

    PubMed

    Cole-Hunter, Tom; Weichenthal, Scott; Kubesch, Nadine; Foraster, Maria; Carrasco-Turigas, Glòria; Bouso, Laura; Martínez, David; Westerdahl, Dane; de Nazelle, Audrey; Nieuwenhuijsen, Mark

    2016-01-01

    People are often exposed to traffic-related air pollution (TRAP) during physical activity (PA), but it is not clear if PA modifies the impact of TRAP on cardiac autonomic modulation. We conducted a panel study among 28 healthy adults in Barcelona, Spain to examine how PA may modify the impact of TRAP on cardiac autonomic regulation. Participants completed four 2-h exposure scenarios that included either rest or intermittent exercise in high- and low-traffic environments. Time- and frequency-domain measures of heart rate variability (HRV) were monitored during each exposure period along with continuous measures of TRAP. Linear mixed-effects models were used to estimate the impact of TRAP on HRV as well as potential effect modification by PA. Exposure to TRAP was associated with consistent decreases in HRV; however, exposure-response relationships were not always linear over the broad range of exposures. For example, each 10 μg/m(3) increase in black carbon was associated with a 23% (95% CI: -31, -13) decrease in high frequency power at the low-traffic site, whereas no association was observed at the high-traffic site. PA modified the impact of TRAP on HRV at the high-traffic site and tended to weaken inverse associations with measures reflecting parasympathetic modulation (P ≤ 0.001). Evidence of effect modification at the low-traffic site was less consistent. The strength and direction of the relationship between TRAP and HRV may vary across exposure gradients. PA may modify the impact of TRAP on HRV, particularly at higher concentrations.

  5. Development and validity of a 3-day smartphone-assisted 24-hour recall to assess beverage consumption in a Chinese population: a randomized cross-over study

    PubMed Central

    Smith, Lindsey P.; Hua, Jenna; Seto, Edmund; Du, Shufa; Zang, Jiajie; Zou, Shurong; Popkin, Barry M.; Mendez, Michelle A.

    2014-01-01

    This paper addresses the need for diet assessment methods that capture the rapidly changing beverage consumption patterns in China. The objective of this study was to develop a 3-day smartphone-assisted 24-hour recall to improve the quantification of beverage intake amongst young Chinese adults (n=110) and validate, in a small subset (n=34), the extent to which the written record and smartphone-assisted recalls adequately estimated total fluid intake, using 24-hour urine samples. The smartphone-assisted method showed improved validity compared to the written-assisted method, when comparing reported total fluid intake to total urine volume. However, participants reported consuming fewer beverages on the smartphone-assisted method compared to the written-assisted method, primarily due to decreased consumption of traditional zero-energy beverages (i.e. water, tea) in the smartphone-assisted method. It is unclear why participants reported fewer beverages in the smartphone-assisted method than the written-assisted method. One possibility is that participants found the smartphone method too cumbersome, and responded by decreasing beverage intake. These results suggest that smartphone-assisted 24-hour recalls perform comparably but do not appear to substantially improve beverage quantification compared to the current written record based approach. In addition, we piloted a beverage screener to identify consumers of episodically consumed SSBs. As expected, a substantially higher proportion of consumers reported consuming SSBs on the beverage screener compared to either recall type, suggesting that a beverage screener may be useful in characterizing consumption of episodically consumed beverages in China’s dynamic food and beverage landscape. PMID:25516327

  6. Short-term effects of three chest physiotherapy regimens in patients hospitalized for pulmonary exacerbations of cystic fibrosis: a cross-over randomized study.

    PubMed

    Braggion, C; Cappelletti, L M; Cornacchia, M; Zanolla, L; Mastella, G

    1995-01-01

    The aim of our study was to compare the short-term efficacy of three different chest physiotherapy (CPT) regimens (PD, postural drainage; PEP, positive expiratory pressure physiotherapy; HFCC, high-frequency chest compression physiotherapy) on patients with cystic fibrosis (CF) hospitalized for an acute pulmonary exacerbation. Sixteen patients with CF, 8 males, 8 females, aged 15-27 years (mean, 20.3 +/- 4), met the inclusion criteria: 1) age over 14 years; 2) mild or moderate airway obstruction; 3) sputum volume > 30 mL/day; 4) being proficient in PD and PEP CPT. Patients at admission had (mean +/- SD) forced volume in 1 second (FEV1) 52.2 +/- 21.9 percent predicted; Shwachman-Kulczycki clinical score 65.1 +/- 11 points; Chrispin-Norman chest radiography score 18.6 +/- 4.3 points. The three CPT regimens and a control-treatment (CONT) were administered in a random sequence, each patient receiving each treatment twice a day (in 50 minute sessions) for 2 consecutive days. During CONT and for 30 minutes after each session only spontaneous coughing was allowed. Wet and dry weight of sputum were recorded during the 50-minute sessions and 30 minutes afterward. Lung function was measured before and 30 minutes after each session. For each treatment a score was given by the patient for efficacy, and by both the patient and the physiotherapist for tolerance. Wet and dry weights of sputum collected during the sessions were greater for all CPT regimens than for CONT (P < 0.001, P < 0.0001). No significant differences between the three CPT regimens for both wet and dry weights were found when the number of coughs was taken into account.(ABSTRACT TRUNCATED AT 250 WORDS)

  7. Preexercise urine specific gravity and fluid intake during one-hour running in a thermoneutral environment - a randomized cross-over study.

    PubMed

    Silva, Rafael P; Mündel, Toby; Altoé, Janaína L; Saldanha, Mônica R; Ferreira, Fabrícia G; Marins, João C B

    2010-01-01

    Urine specific gravity is often used to assess hydration status. Athletes who are hypohydrated prior to exercise tend to ingest more fluid during the exercise, possibly to compensate for their pre exercise fluid deficit. The purpose of this study was to evaluate the effect of additional fluid intake on fluid balance and gastrointestinal tract comfort during 1h running in a thermoneutral environment when athletes followed their habitual fluid and dietary regimes. Sixteen men and sixteen women ingested a 6% carbohydrate-electrolyte solution immediately prior to exercise and then every 15 minutes during two runs, with a consumption rate of 2 mL.kg(-1) (LV, lower volume) or 3 mL.kg(-1) (HV, higher volume) body mass. Urine specific gravity and body mass changes were determined before and after the tests to estimate hydration status. During exercise subjects verbally responded to surveys inquiring about gastrointestinal symptoms, sensation of thirst and ratings of perceived exertion. Plasma glucose, heart rate and blood pressure were also evaluated. Men had higher preexercise urine specific gravity than women (1.025 vs. 1.016 g·mL(-1) HV; and 1.024 vs. 1.017 g·mL(-1) LV) and greater sweat loss (1.21 ± 0.27 L vs. 0.83 ± 0.21 L HV; and 1.18 ± 0.23 L vs. 0.77 ± 0.17 LV). Prevalence of gastrointestinal discomfort increased after 45 min. No significant differences on heart rate, rate of perceived exertion, blood pressure or glycemia was observed with the additional fluid intake. From these results it appears that additional fluid intake reduces body mass loss and thirst sensation. When compared to the men, however, preexercise euhydration was more common in women and an increased fluid intake increases the risk of body mass gain and gastrointestinal discomfort. Key pointsThere seems to be a wide variability in pre-exercise hydration status between male and female and efforts aimed at educating athletes about the importance of pregame hydration must be emphasized

  8. An Open, Randomized, Single-Center, Crossover Pharmacokinetic Study of Meropenem after Intraperitoneal and Intravenous Administration in Patients Receiving Automated Peritoneal Dialysis.

    PubMed

    Wiesholzer, Martin; Pichler, Petra; Reznicek, Gottfried; Wimmer, Michaela; Kussmann, Manuel; Balcke, Peter; Burgmann, Heinz; Zeitlinger, Markus; Poeppl, Wolfgang

    2016-05-01

    The objective of this study was to determine the pharmacokinetic profile of meropenem in automated peritoneal dialysis (APD) patients. In 6 patients without peritonitis, a single dose of 0.5 g of meropenem was applied intraperitoneally (i.p.) or intravenously (i.v.) and concentrations in serum and dialysate were measured at specified intervals over 24 h with high-performance liquid chromatography-mass spectrometry. The mean maximum concentrations of meropenem in serum (Cmax) were 27.2 mg/liter (standard deviation [SD], ±6.9) and 10.1 mg/liter (SD, ±2.5) and in dialysate were 3.6 mg/liter (SD, ±2.3) and 185.8 mg/liter (SD, ±18.7) after i.v. and i.p. administrations, respectively. The mean areas under the curve from 0 to 24 (AUC0-24) of meropenem in serum were 173.5 mg · h/liter (SD, ±29.7) and 141.4 mg · h/liter (SD, ±37.5) (P = 0.046) and in dialysate were 42.6 mg · h/liter (SD, ±20.0) and 623.4 mg · h/liter (SD, ±84.1) (P = 0.028) after i.v. and i.p. administrations, respectively. The ratios for dialysate exposure over plasma exposure after i.v. and i.p. treatments were 0.2 (SD, ±0.1) and 4.6 (SD, ±0.9), respectively (P = 0.031). A mean target value of 40% T>MIC (time for which the free meropenem concentration exceeds the MIC) for clinically relevant pathogens with EUCAST susceptibility breakpoints of 2 mg/liter was reached in serum after i.p. and i.v. administrations and in dialysate after i.p. but not after i.v. administration. The present data indicate that low i.p. exposure limits the i.v. use of meropenem for PD-associated peritonitis. In contrast, i.p. administration not only results in superior concentrations in dialysate but also might be used to treat systemic infections. PMID:26902765

  9. Crossover from quantum to classical transport

    NASA Astrophysics Data System (ADS)

    Morr, Dirk K.

    2016-01-01

    Understanding the crossover from quantum to classical transport has become of fundamental importance not only for technological applications due to the creation of sub-10-nm transistors - an important building block of our modern life - but also for elucidating the role played by quantum mechanics in the evolutionary fitness of biological complexes. This article provides a basic introduction into the nature of charge and energy transport in the quantum and classical regimes. It discusses the characteristic transport properties in both limits and demonstrates how they can be connected through the loss of quantum mechanical coherence. The salient features of the crossover physics are identified, and their importance in opening new transport regimes and in understanding efficient and robust energy transport in biological complexes are demonstrated.

  10. Miscible viscous fingering in three dimensions: fractal-to-compact crossover and interfacial roughness.

    PubMed

    Ferer, M; Bromhal, Grant S; Smith, Duane H

    2009-07-01

    Using our standard pore-level model, we have extended our earlier study of the crossover from fractal viscous fingering to compact /linear flow at a characteristic crossover time, tau , in three dimensions to systems with as many as a 10(6) pore bodies. These larger systems enable us to investigate the flows in the fully compact/well-past-crossover regime. The center of mass of the injected fluid exhibits basically the same behavior as found earlier but with an improved characteristic time. However, our earlier study of much smaller systems was unable to study the interfacial width in the important well-past-crossover regime, ttau. Now, we can study both the time evolution and roughness of the interfacial width. The interfacial width exhibits the same fractal-to-compact crossover as the center of mass, with the same characteristic time. In the fully compact regime, ttau, the interfacial width grows approximately linearly with time so that the standard growth exponent is approximately unity, beta=1.0+/-0.1. We find that neither is the interface self-affine nor is the roughness of the interface in the compact regime consistent with an effective long-range surface tension as assumed by various theories. In fact, similar to Lévy flights, the height variations across the interface appear to be random with occasional large height variations. PMID:19658710

  11. Miscible viscous fingering in three dimensions: Fractal-to-compact crossover and interfacial roughness

    SciTech Connect

    Ferer, M.; Bromhal, Grant S.; Smith, Duane H.

    2009-07-01

    Using our standard pore-level model, we have extended our earlier study of the crossover from fractal viscous fingering to compact/linear flow at a characteristic crossover time, τ, in three dimensions to systems with as many as a 106 pore bodies. These larger systems enable us to investigate the flows in the fully compact/well-past-crossover regime. The center of mass of the injected fluid exhibits basically the same behavior as found earlier but with an improved characteristic time. However, our earlier study of much smaller systems was unable to study the interfacial width in the important well-past-crossover regime, t >> τ. Now, we can study both the time evolution and roughness of the interfacial width. The interfacial width exhibits the same fractal-to-compact crossover as the center of mass, with the same characteristic time. In the fully compact regime, t >> τ, the interfacial width grows approximately linearly with time so that the standard growth exponent is approximately unity, β=1.0±0.1. We find that neither is the interface self-affine nor is the roughness of the interface in the compact regime consistent with an effective long-range surface tension as assumed by various theories. In fact, similar to Levy flights, the height variations across the interface appear to be random with occasional large height variations.

  12. JavaGenes: Evolving Graphs with Crossover

    NASA Technical Reports Server (NTRS)

    Globus, Al; Atsatt, Sean; Lawton, John; Wipke, Todd

    2000-01-01

    Genetic algorithms usually use string or tree representations. We have developed a novel crossover operator for a directed and undirected graph representation, and used this operator to evolve molecules and circuits. Unlike strings or trees, a single point in the representation cannot divide every possible graph into two parts, because graphs may contain cycles. Thus, the crossover operator is non-trivial. A steady-state, tournament selection genetic algorithm code (JavaGenes) was written to implement and test the graph crossover operator. All runs were executed by cycle-scavagging on networked workstations using the Condor batch processing system. The JavaGenes code has evolved pharmaceutical drug molecules and simple digital circuits. Results to date suggest that JavaGenes can evolve moderate sized drug molecules and very small circuits in reasonable time. The algorithm has greater difficulty with somewhat larger circuits, suggesting that directed graphs (circuits) are more difficult to evolve than undirected graphs (molecules), although necessary differences in the crossover operator may also explain the results. In principle, JavaGenes should be able to evolve other graph-representable systems, such as transportation networks, metabolic pathways, and computer networks. However, large graphs evolve significantly slower than smaller graphs, presumably because the space-of-all-graphs explodes combinatorially with graph size. Since the representation strongly affects genetic algorithm performance, adding graphs to the evolutionary programmer's bag-of-tricks should be beneficial. Also, since graph evolution operates directly on the phenotype, the genotype-phenotype translation step, common in genetic algorithm work, is eliminated.

  13. Assessing the effectiveness of 3 months day and night home closed-loop insulin delivery in adults with suboptimally controlled type 1 diabetes: a randomised crossover study protocol

    PubMed Central

    Leelarathna, Lalantha; Dellweg, Sibylle; Mader, Julia K; Barnard, Katharine; Benesch, Carsten; Ellmerer, Martin; Heinemann, Lutz; Kojzar, Harald; Thabit, Hood; Wilinska, Malgorzata E; Wysocki, Tim; Pieber, Thomas R; Arnolds, Sabine; Evans, Mark L; Hovorka, Roman

    2014-01-01

    Introduction Despite therapeutic advances, many people with type 1 diabetes are still unable to achieve optimal glycaemic control, limited by the occurrence of hypoglycaemia. The objective of the present study is to determine the effectiveness of day and night home closed-loop over the medium term compared with sensor-augmented pump therapy in adults with type 1 diabetes and suboptimal glycaemic control. Methods and analysis The study will adopt an open label, three-centre, multinational, randomised, two-period crossover study design comparing automated closed-loop glucose control with sensor augmented insulin pump therapy. The study will aim for 30 completed participants. Eligible participants will be adults (≥18 years) with type 1 diabetes treated with insulin pump therapy and suboptimal glycaemic control (glycated haemoglobin (HbA1c) ≥7.5% (58 mmol/mmol) and ≤10% (86 mmol/mmol)). Following a 4-week optimisation period, participants will undergo a 3-month use of automated closed-loop insulin delivery and sensor-augmented pump therapy, with a 4–6 week washout period in between. The order of the interventions will be random. All analysis will be conducted on an intention to treat basis. The primary outcome is the time spent in the target glucose range from 3.9 to 10.0 mmol/L based on continuous glucose monitoring levels during the 3 months free living phase. Secondary outcomes include HbA1c changes; mean glucose and time spent above and below target glucose levels. Further, participants will be invited at baseline, midpoint and study end to participate in semistructured interviews and complete questionnaires to explore usability and acceptance of the technology, impact on quality of life and fear of hypoglycaemia. Ethics and dissemination Ethical approval has been obtained at all sites. Before screening, all participants will be provided with oral and written information about the trial. The study will be disseminated by peer-review publications

  14. Quantum-classical crossover in electrodynamics

    SciTech Connect

    Polonyi, Janos

    2006-09-15

    A classical field theory is proposed for the electric current and the electromagnetic field interpolating between microscopic and macroscopic domains. It represents a generalization of the density functional for the dynamics of the current and the electromagnetic field in the quantum side of the crossover and reproduces standard classical electrodynamics on the other side. The effective action derived in the closed time path formalism and the equations of motion follow from the variational principle. The polarization of the Dirac-sea can be taken into account in the quadratic approximation of the action by the introduction of the deplacement field strengths as in conventional classical electrodynamics. Decoherence appears naturally as a simple one-loop effect in this formalism. It is argued that the radiation time arrow is generated from the quantum boundary conditions in time by decoherence at the quantum-classical crossover and the Abraham-Lorentz force arises from the accelerating charge or from other charges in the macroscopic or the microscopic side, respectively. The functional form of the quantum renormalization group, the generalization of the renormalization group method for the density matrix, is proposed to follow the scale dependence through the quantum-classical crossover in a systematical manner.

  15. Intrinsic DNA curvature of double-crossover tiles.

    PubMed

    Kim, Seungjae; Kim, Junghoon; Qian, Pengfei; Shin, Jihoon; Amin, Rashid; Ahn, Sang Jung; LaBean, Thomas H; Kim, Moon Ki; Park, Sung Ha

    2011-06-17

    A theoretical model which takes into account the structural distortion of double-crossover DNA tiles has been studied to investigate its effect on lattice formation sizes. It has been found that a single vector appropriately describes the curvature of the tiles, of which a higher magnitude hinders lattice growth. In conjunction with these calculations, normal mode analysis reveals that tiles with relative higher frequencies have an analogous effect. All the theoretical results are shown to be in good agreement with experimental data. PMID:21543827

  16. Covariance and crossover matrix guided differential evolution for global numerical optimization.

    PubMed

    Li, YongLi; Feng, JinFu; Hu, JunHua

    2016-01-01

    Differential evolution (DE) is an efficient and robust evolutionary algorithm and has wide application in various science and engineering fields. DE is sensitive to the selection of mutation and crossover strategies and their associated control parameters. However, the structure and implementation of DEs are becoming more complex because of the diverse mutation and crossover strategies that use distinct parameter settings during the different stages of the evolution. A novel strategy is used in this study to improve the crossover and mutation operations. The crossover matrix, instead of a crossover operator and its control parameter CR, is proposed to implement the function of the crossover operation. Meanwhile, Gaussian distribution centers the best individuals found in each generation based on the proposed covariance matrix, which is generated between the best individual and several better individuals. Improved mutation operator based on the crossover matrix is randomly selected to generate the trial population. This operator is used to generate high-quality solutions to improve the capability of exploitation and enhance the preference of exploration. In addition, the memory population is randomly chosen from previous generation and used to control the search direction in the novel mutation strategy. Accordingly, the diversity of the population is improved. Thus, CCDE, which is a novel efficient and simple DE variant, is presented in this paper. CCDE has been tested on 30 benchmarks and 5 real-world optimization problems from the IEEE Congress on Evolutionary Computation (CEC) 2014 and CEC 2011, respectively. Experimental and statistical results demonstrate the effectiveness of CCDE for global numerical and engineering optimization. CCDE can solve the test benchmark functions and engineering problems more successfully than the other DE variants and algorithms from CEC 2014.

  17. Covariance and crossover matrix guided differential evolution for global numerical optimization.

    PubMed

    Li, YongLi; Feng, JinFu; Hu, JunHua

    2016-01-01

    Differential evolution (DE) is an efficient and robust evolutionary algorithm and has wide application in various science and engineering fields. DE is sensitive to the selection of mutation and crossover strategies and their associated control parameters. However, the structure and implementation of DEs are becoming more complex because of the diverse mutation and crossover strategies that use distinct parameter settings during the different stages of the evolution. A novel strategy is used in this study to improve the crossover and mutation operations. The crossover matrix, instead of a crossover operator and its control parameter CR, is proposed to implement the function of the crossover operation. Meanwhile, Gaussian distribution centers the best individuals found in each generation based on the proposed covariance matrix, which is generated between the best individual and several better individuals. Improved mutation operator based on the crossover matrix is randomly selected to generate the trial population. This operator is used to generate high-quality solutions to improve the capability of exploitation and enhance the preference of exploration. In addition, the memory population is randomly chosen from previous generation and used to control the search direction in the novel mutation strategy. Accordingly, the diversity of the population is improved. Thus, CCDE, which is a novel efficient and simple DE variant, is presented in this paper. CCDE has been tested on 30 benchmarks and 5 real-world optimization problems from the IEEE Congress on Evolutionary Computation (CEC) 2014 and CEC 2011, respectively. Experimental and statistical results demonstrate the effectiveness of CCDE for global numerical and engineering optimization. CCDE can solve the test benchmark functions and engineering problems more successfully than the other DE variants and algorithms from CEC 2014. PMID:27512635

  18. Crossover from anomalous to normal diffusion in porous media

    NASA Astrophysics Data System (ADS)

    Aarão Reis, F. D. A.; di Caprio, Dung

    2014-06-01

    Random walks (RW) of particles adsorbed in the internal walls of porous deposits produced by ballistic-type growth models are studied. The particles start at the external surface of the deposits and enter their pores in order to simulate an external flux of a species towards a porous solid. For short times, the walker concentration decays as a stretched exponential of the depth z, but a crossover to long-time normal diffusion is observed in most samples. The anomalous concentration profile remains at long times in very porous solids if the walker steps are restricted to nearest neighbors and is accompanied with subdiffusion features. These findings are correlated with a decay of the explored area with z. The study of RW of tracer particles left at the internal part of the solid rules out an interpretation by diffusion equations with position-dependent coefficients. A model of RW in a tube of decreasing cross section explains those results by showing long crossovers from an effective subdiffusion regime to an asymptotic normal diffusion. The crossover position and density are analytically calculated for a tube with area decreasing exponentially with z and show good agreement with numerical data. The anomalous decay of the concentration profile is interpreted as a templating effect of the tube shape on the total number of diffusing particles at each depth, while the volumetric concentration in the actually explored porous region may not have significant decay. These results may explain the anomalous diffusion of metal atoms in porous deposits observed in recent works. They also confirm the difficulty in interpreting experimental or computational data on anomalous transport reported in recent works, particularly if only the concentration profiles are measured.

  19. Geosat crossover analysis in the tropical Pacific. Part 1: Constrained sinusoidal crossover adjustment

    NASA Technical Reports Server (NTRS)

    Tai, Chang-Kou

    1988-01-01

    A new method (constrained sinusoidal crossover adjustment) for removing the orbit error in satellite altimetry is tested (using crossovers accumulated in the first 91 days of the Geosat non-repeat era in the tropical Pacific) and found to have excellent qualities. Two features distinguish the new method from the conventional bias-and-tilt crossover adjustment. First, a sine wave (with wavelength equaling the circumference of the Earth) is used to represent the orbit error for each satellite revolution, instead of the bias-and-tilt (and curvature, if necessary) approach for each segment of the satellite ground track. Secondly, the indeterminacy of the adjustment process is removed by a simple constraint minimizing the amplitudes of the sine waves, rather than by fixing selected tracks. Overall the new method is more accurate, more efficient, and much less cumbersome than the old. The idea of restricting the crossover adjustment to crossovers between tracks that are less than certain days apart in order to preserve the large-scale long-term oceanic variability is also tested with inconclusive results because the orbit error was unusually nonstationary in the initial 91 days of the GEOSAT mission.

  20. The effects of a muscle resistance program on the functional capacity, knee extensor muscle strength and plasma levels of IL-6 and TNF-α in pre-frail elderly women: a randomized crossover clinical trial - a study protocol

    PubMed Central

    2010-01-01

    Background With the increase in the elderly population, a growing number of chronic degenerative diseases and a greater dependency on caregivers have been observed. Elderly persons in states of frailty remain more susceptible to significant health complications. There is evidence of an inverse relationship between plasma levels of inflammatory mediators and levels of functionality and muscle strength, suggesting that muscle-strengthening measures can aid in inflammatory conditions. The purpose of this study will be verified the effect of a muscle-strengthening program with load during a ten-week period in pre-frail elderly women with attention to the following outcomes: (1) plasma levels of interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-α), (2) functional capacity and (3) knee extensor muscle strength. Methods/Design The study design is a randomized crossover clinical trial evaluating 26 elderly women (regardless of their race and/or social condition) who are community residents, older than 65, and classified as pre-frail according to the criteria previously described by Fried et al. (2004). All subjects will be assessed using the Timed up and go and 10-Meter Walk Test functional tests. The plasma levels of IL-6 and TNF-α will be assessed by ELISA (enzyme-linked immunosorbent assay) with high sensitivity kits (Quantikine®HS, R&D Systems Minneapolis, MN, U.S.). Knee extensor muscle strength will be assessed using the Byodex System 3 Pro® isokinetic dynamometer at angular speeds of 60 and 180°/s. The intervention will consist of strengthening exercises of the lower extremities at 50 to 70% of 1RM (maximal resistance) three times per week for ten weeks. The volunteers will be randomized into two groups: group E, the intervention group, and group C, the control group that did not initiate any new activities during the initial study period (ten weeks). After the initial period, group C will begin the intervention and group E will maintain everyday

  1. Effect of supplementation of fermented milk drink containing probiotic Lactobacillus casei Shirota on the concentrations of aflatoxin biomarkers among employees of Universiti Putra Malaysia: a randomised, double-blind, cross-over, placebo-controlled study.

    PubMed

    Mohd Redzwan, Sabran; Abd Mutalib, Mohd Sokhini; Wang, Jia-Sheng; Ahmad, Zuraini; Kang, Min-Su; Abdul Rahman, Nurul 'Aqilah; Nikbakht Nasrabadi, Elham; Jamaluddin, Rosita

    2016-01-14

    Human exposure to aflatoxin is through the diet, and probiotics are able to bind aflatoxin and prevent its absorption in the small intestine. This study aimed to determine the effectiveness of a fermented milk drink containing Lactobacillus casei Shirota (LcS) (probiotic drink) to prevent aflatoxin absorption and reduce serum aflatoxin B1-lysine adduct (AFB1-lys) and urinary aflatoxin M1 concentrations. The present study was a randomised, double-blind, cross-over, placebo-controlled study with two 4-week intervention phases. In all, seventy-one subjects recruited from the screening stage were divided into two groups--the Yellow group and the Blue group. In the 1st phase, one group received probiotic drinks twice a day and the other group received placebo drinks. Blood and urine samples were collected at baseline, 2nd and 4th week of the intervention. After a 2-week wash-out period, the treatments were switched between the groups, and blood and urine samples were collected at the 6th, 8th and 10th week (2nd phase) of the intervention. No significant differences in aflatoxin biomarker concentrations were observed during the intervention. A within-group analysis was further carried out. Aflatoxin biomarker concentrations were not significantly different in the Yellow group. Nevertheless, ANOVA for repeated measurements indicated that AFB1-lys concentrations were significantly different (P=0·035) with the probiotic intervention in the Blue group. The 2nd week AFB1-lys concentrations (5·14 (SD 2·15) pg/mg albumin (ALB)) were significantly reduced (P=0·048) compared with the baseline (6·24 (SD 3·42) pg/mg ALB). Besides, the 4th week AFB1-lys concentrations were significantly lower (P<0·05) with probiotic supplementation than with the placebo. Based on these findings, a longer intervention study is warranted to investigate the effects of continuous LcS consumption to prevent dietary aflatoxin exposure. PMID:26490018

  2. Dietary Advanced Glycation End Products Consumption as a Direct Modulator of Insulin Sensitivity in Overweight Humans: A Study Protocol for a Double-Blind, Randomized, Two Period Cross-Over Trial

    PubMed Central

    de Courten, Maximilian PJ; Schalkwijk, Casper G; Walker, Karen Z; Forbes, Josephine

    2015-01-01

    Background Advanced glycation end products (AGEs) are formed during the processing, storage, and cooking of foods. As part of a western diet, AGEs are consumed in excess and impair glucose metabolism in patients with type 2 diabetes. In the absence of diabetes, AGE-mediated decreases in insulin sensitivity and signaling have been postulated. However, randomized studies to test this relationship in humans are limited. Objective The primary aim of this trial is to determine whether dietary consumption of AGEs will decrease insulin sensitivity in healthy overweight adults. A secondary aim is to determine the effects of dietary AGEs on insulin secretion, circulating soluble receptor for AGEs (sRAGE), and inflammation markers. Methods Overweight, but otherwise healthy, non-diabetic adults (N=20) aged 18-50 years old will complete a randomized cross-over design intervention study alternating low and high (4-fold increase) AGE diets (2-week duration). At baseline, participants will undergo a medical review including an intravenous glucose tolerance test (IVGTT), a hyperinsulinemic-euglycemic clamp, and anthropometric measures and questionnaires assessing diet, physical activity, and general wellness. Each test diet will be followed for 14 days, followed by a 4-week washout period before commencement of the second alternate dietary period. Energy, macronutrient, and AGE intake will be calculated for each dietary period. Additionally, the AGE content of foods used in the study will be measured by ultra performance liquid chromatography mass spectrometry. All measurements will be repeated at the beginning and end of each dietary period. Primary and secondary outcomes will be expressed as a change over the dietary period for insulin sensitivity, secretion, anthropometric parameters, sRAGE, and inflammation markers and compared by paired t test and analysis of variance (ANOVA). Results The study will be completed in early 2016. Conclusion The proposed trial will provide much

  3. Religious attendance and mortality: implications for the black-white mortality crossover.

    PubMed

    Dupre, Matthew E; Franzese, Alexis T; Parrado, Emilio A

    2006-02-01

    This study investigates the relationships among religious attendance, mortality, and the black-white mortality crossover. We build on prior research by examining the link between attendance and mortality while testing whether religious involvement captures an important source of population heterogeneity that contributes to a crossover Using data from the Established Populations for Epidemiologic Studies of the Elderly, we find a strong negative association between attendance and mortality. Our results also show evidence of a racial crossover in mortality rates for both men and women. When religious attendance is modeled in terms of differential frailty, clear gender differences emerge. For women, the effect of attendance is race- and age-dependent, modifying the age at crossover by 10 years. For men, however; the effect of attendance is not related to race and does not alter the crossover pattern. When other health risks are modeled in terms of differential frailty, wefind neither race nor age-related effects. Overall, the results highlight the importance of considering religious attendance when examining racial and gender differences in age-specific mortality rates.

  4. REC, Drosophila MCM8, drives formation of meiotic crossovers.

    PubMed

    Blanton, Hunter L; Radford, Sarah J; McMahan, Susan; Kearney, Hutton M; Ibrahim, Joseph G; Sekelsky, Jeff

    2005-09-01

    Crossovers ensure the accurate segregation of homologous chromosomes from one another during meiosis. Here, we describe the identity and function of the Drosophila melanogaster gene recombination defective (rec), which is required for most meiotic crossing over. We show that rec encodes a member of the mini-chromosome maintenance (MCM) protein family. Six MCM proteins (MCM2-7) are essential for DNA replication and are found in all eukaryotes. REC is the Drosophila ortholog of the recently identified seventh member of this family, MCM8. Our phylogenetic analysis reveals the existence of yet another family member, MCM9, and shows that MCM8 and MCM9 arose early in eukaryotic evolution, though one or both have been lost in multiple eukaryotic lineages. Drosophila has lost MCM9 but retained MCM8, represented by REC. We used genetic and molecular methods to study the function of REC in meiotic recombination. Epistasis experiments suggest that REC acts after the Rad51 ortholog SPN-A but before the endonuclease MEI-9. Although crossovers are reduced by 95% in rec mutants, the frequency of noncrossover gene conversion is significantly increased. Interestingly, gene conversion tracts in rec mutants are about half the length of tracts in wild-type flies. To account for these phenotypes, we propose that REC facilitates repair synthesis during meiotic recombination. In the absence of REC, synthesis does not proceed far enough to allow formation of an intermediate that can give rise to crossovers, and recombination proceeds via synthesis-dependent strand annealing to generate only noncrossover products.

  5. Early bronchodilator action of glycopyrronium versus tiotropium in moderate-to-severe COPD patients: a cross-over blinded randomized study (Symptoms and Pulmonary function in the moRnING)

    PubMed Central

    Marin, Jose M; Beeh, Kai M; Clemens, Andreas; Castellani, Walter; Schaper, Lennart; Saralaya, Dinesh; Gunstone, Anthony; Casamor, Ricard; Kostikas, Konstantinos; Aalamian-Mattheis, Maryam

    2016-01-01

    Background Morning symptoms associated with COPD have a negative impact on patients’ quality of life. Long-acting bronchodilators with rapid onset may relieve patients’ symptoms. In the Symptoms and Pulmonary function in the moRnING study, we prospectively compared the rapid onset bronchodilator profile of glycopyrronium (GLY) and tiotropium (TIO) during the first few hours after dosing in patients with moderate-to-severe COPD. Methods Patients were randomized (1:1) to receive either once-daily GLY (50 μg) or TIO (18 μg) and corresponding placebos in a cross-over design for 28 days. The primary objective was to demonstrate the superiority of GLY versus TIO in area under the curve from 0 to 4 hours (AUC0-4h) forced expiratory volume in 1 second (FEV1) after the first dose. The secondary objective was to compare GLY versus TIO using the patient reported outcomes Morning COPD Symptoms Questionnaire 3 hours post-inhalation. Results One-hundred and twenty-six patients were randomized (male 70.2%; mean age 65.7 years) and 108 patients completed the study. On Day 1, GLY resulted in significantly higher FEV1 AUC0-4h after the first dose versus TIO (treatment difference [Δ], 0.030 L, 95% confidence interval 0.004–0.056, P=0.025). Improvements in morning COPD symptoms from baseline at Days 1 and 28 were similar between GLY and TIO. Post hoc analysis of the FEV1 AUC0-4h by time point on Day 1 showed significant improvements in patients receiving GLY versus TIO at 5 minutes (Δ=0.029 L, P=0.015), 15 minutes (Δ=0.033 L, P=0.026), and 1 hour (Δ=0.044 L, P=0.014). Safety results were comparable between both treatments. Conclusion The SPRING study demonstrates the superiority of GLY versus TIO in terms of superior bronchodilation in the first 4 hours after administration, thus extending the clinical data that support a faster onset of action of GLY versus TIO. PMID:27418815

  6. Influence of habitual dietary fibre intake on the responsiveness of the gut microbiota to a prebiotic: protocol for a randomised, double-blind, placebo-controlled, cross-over, single-centre study

    PubMed Central

    Healey, Genelle; Brough, Louise; Butts, Chrissie; Murphy, Rinki; Whelan, Kevin; Coad, Jane

    2016-01-01

    Introduction The commensal gut microbiota have been shown to have an impact on human health as aberrant gut microbiota have been linked to disease. Dietary constituents are influential in shaping the gut microbiota. Diet-specific therapeutic strategies may therefore play a role in optimising human health via beneficial manipulation of the gut microbiota. Research has suggested that an individual's baseline gut microbiota composition may influence how the gut microbiota respond to a dietary intervention and individuals with differing habitual dietary intakes appear to have distinct baseline gut microbiota compositions. The responsiveness of the gut microbiota may therefore be influenced by habitual dietary intakes. This study aims to investigate what influence differing habitual dietary fibre intakes have on the responsiveness of the gut microbiota to a prebiotic intervention. Methods and analysis In this randomised, double-blind, placebo-controlled, cross-over, single-centre study, 20 low dietary fibre (dietary fibre intake <18 g/day for females and <22 g/day for males) and 20 high dietary fibre (dietary fibre intake ≥25 g/day for females and ≥30 g/day for males) consumers will be recruited. Participants will be randomised to a placebo (Glucidex 29 Premium) or a prebiotic (Synergy 1) intervention for 3 weeks with a 3-week washout followed by 3 weeks of the alternative intervention. Outcome measures of gut microbiota composition (using 16S rRNA gene sequencing) and functional capacity (faecal short chain fatty acid concentrations and Phylogenetic Investigation of Communities by Reconstruction of Unobserved States (PICRUSt)) as well as appetite (visual analogue scale appetite questionnaire) will be assessed at the beginning and end of each intervention phase. Ethics and dissemination The Massey University Human Ethics Committee approved this study (Massey University HEC: Southern A application—15/34). Results will be disseminated through peer

  7. A new crossover operator in genetic programming for object classification.

    PubMed

    Zhang, Mengjie; Gao, Xiaoying; Lou, Weijun

    2007-10-01

    The crossover operator has been considered "the centre of the storm" in genetic programming (GP). However, many existing GP approaches to object recognition suggest that the standard GP crossover is not sufficiently powerful in producing good child programs due to the totally random choice of the crossover points. To deal with this problem, this paper introduces an approach with a new crossover operator in GP for object recognition, particularly object classification. In this approach, a local hill-climbing search is used in constructing good building blocks, a weight called looseness is introduced to identify the good building blocks in individual programs, and the looseness values are used as heuristics in choosing appropriate crossover points to preserve good building blocks. This approach is examined and compared with the standard crossover operator and the headless chicken crossover (HCC) method on a sequence of object classification problems. The results suggest that this approach outperforms the HCC, the standard crossover, and the standard crossover operator with hill climbing on all of these problems in terms of the classification accuracy. Although this ap