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Sample records for 3-way crossover study

  1. Lubiprostone decreases the small bowel transit time by capsule endoscopy: an exploratory, randomised, double-blind, placebo-controlled 3-way crossover study.

    PubMed

    Matsuura, Mizue; Inamori, Masahiko; Endo, Hiroki; Matsuura, Tetsuya; Kanoshima, Kenji; Inoh, Yumi; Fujita, Yuji; Umezawa, Shotaro; Fuyuki, Akiko; Uchiyama, Shiori; Higurashi, Takuma; Ohkubo, Hidenori; Sakai, Eiji; Iida, Hiroshi; Nonaka, Takashi; Futagami, Seiji; Kusakabe, Akihiko; Maeda, Shin; Nakajima, Atsushi

    2014-01-01

    The aim of this study was to investigate the usefulness of lubiprostone for bowel preparation and as a propulsive agent in small bowel endoscopy. Six healthy male volunteers participated in this randomized, 3-way crossover study. The subjects received a 24 μg tablet of lubiprostone 60 minutes prior to the capsule ingestion for capsule endoscopy (CE) and a placebo tablet 30 minutes before the capsule ingestion (L-P regimen), a placebo tablet 60 minutes prior to CE and a 24 μg tablet of lubiprostone 30 minutes prior to CE (P-L regimen), or a placebo tablet 60 minutes prior to r CE and a placebo tablet again 30 minutes prior to CE (P-P regimen). The quality of the capsule endoscopic images and the amount of water in the small bowel were assessed on 5-point scale. The median SBTT was 178.5 (117-407) minutes in the P-P regimen, 122.5 (27-282) minutes in the L-P regimen, and 110.5 (11-331) minutes in the P-L regimen (P = 0.042). This study showed that the use of lubiprostone significantly decreased the SBTT. We also confirmed that lubiprostone was effective for inducing water secretion into the small bowel during CE. PMID:25614738

  2. Lubiprostone Decreases the Small Bowel Transit Time by Capsule Endoscopy: An Exploratory, Randomised, Double-Blind, Placebo-Controlled 3-Way Crossover Study

    PubMed Central

    Matsuura, Mizue; Inamori, Masahiko; Endo, Hiroki; Matsuura, Tetsuya; Kanoshima, Kenji; Inoh, Yumi; Fujita, Yuji; Umezawa, Shotaro; Fuyuki, Akiko; Uchiyama, Shiori; Higurashi, Takuma; Ohkubo, Hidenori; Sakai, Eiji; Iida, Hiroshi; Nonaka, Takashi; Futagami, Seiji; Kusakabe, Akihiko; Maeda, Shin; Nakajima, Atsushi

    2014-01-01

    The aim of this study was to investigate the usefulness of lubiprostone for bowel preparation and as a propulsive agent in small bowel endoscopy. Six healthy male volunteers participated in this randomized, 3-way crossover study. The subjects received a 24 μg tablet of lubiprostone 60 minutes prior to the capsule ingestion for capsule endoscopy (CE) and a placebo tablet 30 minutes before the capsule ingestion (L-P regimen), a placebo tablet 60 minutes prior to CE and a 24 μg tablet of lubiprostone 30 minutes prior to CE (P-L regimen), or a placebo tablet 60 minutes prior to r CE and a placebo tablet again 30 minutes prior to CE (P-P regimen). The quality of the capsule endoscopic images and the amount of water in the small bowel were assessed on 5-point scale. The median SBTT was 178.5 (117–407) minutes in the P-P regimen, 122.5 (27–282) minutes in the L-P regimen, and 110.5 (11–331) minutes in the P-L regimen (P = 0.042). This study showed that the use of lubiprostone significantly decreased the SBTT. We also confirmed that lubiprostone was effective for inducing water secretion into the small bowel during CE. PMID:25614738

  3. 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

  4. 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

  5. A randomized, open-label 3-way crossover study to investigate the relative bioavailability and bioequivalence of crushed sildenafil 20 mg tablets mixed with apple sauce, extemporaneously prepared suspension (EP), and intact sildenafil 20 mg tablets in healthy volunteers under fasting conditions.

    PubMed

    Gao, Xiang; Ndongo, Marie-Noella; Checchio, Tina M; Cook, Jack; Duncan, Barbara; LaBadie, Robert R

    2015-01-01

    The relative bioavailability and bioequivalence of 20-mg doses of a pediatric formulation of sildenafil extemporaneous preparation suspension (EP; 10 mg/mL), the sildenafil 20-mg intact tablet and the crushed sildenafil 20-mg tablet mixed with apple sauce were assessed in a single-dose, randomized, open-label, 3-way crossover study with 18 healthy adult volunteers. Blood samples were collected at predefined times and analyzed for sildenafil plasma concentrations. Natural log-transformed sildenafil pharmacokinetic parameters (Cmax , AUClast , and AUCinf ) were used to estimate relative bioavailability and construct 90% confidence intervals (CI) using a mixed-effects model. Bioequivalence was concluded among the three formulations with one exception, in which the EP suspension showed a 15% decrease in Cmax with a lower 90% CI of 76% compared with the intact tablet. The 15% decrease in sildenafil Cmax is not considered to be clinically relevant. Therefore, the EP suspension is considered to be an appropriate pediatric formulation. All 3 formulations were well tolerated in healthy adult volunteers. PMID:27128005

  6. 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

  7. 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

  8. Academic Crossover Study, University of Hawaii Community Colleges, Fall 1999.

    ERIC Educational Resources Information Center

    Hawaii Univ., Honolulu. Office of the Chancellor for Community Colleges.

    The academic crossover study was developed to answer two questions: (1) What is the course-taking pattern of the different groups of academic majors? (e.g. what is proportion of academic load taken outside the major); and (2) What is the client-serving pattern of the different subject disciplines? (e.g. what are the groups of students served by…

  9. 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…

  10. 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

  11. Interpretation and bias in case-crossover studies.

    PubMed

    Redelmeier, D A; Tibshirani, R J

    1997-11-01

    The case-crossover design is an innovative epidemiologic technique with distinct strengths and limitations. We review the fundamental logic of this self-matching non-randomized design and direct attention to 15 concerns related to the available data, unavailable data, analytic technique, quantitative statistics, and etiologic model. Implications for each concern are discussed in the context of a recent report on whether cellular telephone calls are associated with an increased risk of a motor vehicle collision. We suggest that an understanding of the case-crossover design may help investigators explore selected questions in behavioral medical research. PMID:9393384

  12. 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

  13. 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.

  14. 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

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

    PubMed Central

    Frazzitta, G.; Bossio, F.; Maestri, R.; Palamara, G.; Bera, R.; Ferrazzoli, D.

    2015-01-01

    Balance dysfunctions are a major challenge in the treatment of Parkinson's disease (PD). Previous studies have shown that rehabilitation can play a role in their treatment. In this study, we have compared the efficacy of two different devices for balance training: stabilometric platform and crossover. We have enrolled 60 PD patients randomly assigned to two groups. The first one (stabilometric group) performed a 4-week cycle of balance training, using the stabilometric platform, whereas the second one (crossover group) performed a 4-week cycle of balance training, using the crossover. The outcome measures used were Unified Parkinson's Disease Rating Scale (UPDRS) part II, Berg Balance Scale (BBS), Timed Up and Go (TUG), and Six Minutes Walking Test (6MWT). Results showed that TUG, BBS, and UPDRS II improved in both groups. There was not difference in the efficacy of the two balance treatments. Patients in both groups improved also the meters walked in the 6MWT at the end of rehabilitation, but the improvement was better for patients performing crossover training. Our results show that the crossover and the stabilometric platform have the same effect on balance dysfunction of Parkinsonian patients, while crossover gets better results on the walking capacity. PMID:26583142

  16. 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.

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

    PubMed

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

    2016-09-01

    Crossover design has been widely used in late-phase clinical studies, as well as in pharmacokinetic and pharmacodynamic, bioequivalence, and medical device studies; however, its interpretability and applicability continue to be debated. Herein we provide discussions around a crossover design's scientific benefit, applicability, and how it can be implemented in late-phase diabetes studies by properly handling key issues: carryover effect, washout period, and baseline selection. Specifically, detailed considerations are provided about the validity and situations of having appropriate length of study duration to deal with carryover effects so that a washout period may not be needed. A simulation study and data mining results on 12 crossover late-phase insulin clinical trials are presented to examine the discussion points and proposals. PMID:27100270

  18. 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…

  19. Aspartame Sensitivity? A Double Blind Randomised Crossover Study

    PubMed Central

    Sathyapalan, Thozhukat; Thatcher, Natalie J.; Hammersley, Richard; Rigby, Alan S.; Pechlivanis, Alexandros; Gooderham, Nigel J.; Holmes, Elaine; le Roux, Carel W.; Atkin, Stephen L.; Courts, Fraser

    2015-01-01

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

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

    NASA Astrophysics Data System (ADS)

    Schwartz, R. A.

    1994-12-01

    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.

  1. 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.

  2. 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.

  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. PMID:26675176

  4. Density Functional Plus Dynamical Mean Field Study of Spin Crossover Molecule

    NASA Astrophysics Data System (ADS)

    Chen, Jia; Millis, Andrew; Marianetti, Chris

    2015-03-01

    We report a density functional plus dynamical mean field study of spin crossover molecule Fe(phen)2(NCS)2. The temperature dependent magnetic susceptibility, Fe-d spectral and total energy were calculated and compared with experimental magnetization, metal L-edge x-ray adsorption spectroscopy. The importance of dynamic effect on energetics is demonstrated by comparison with density functional plus U method, and the role of full charge self-consistency is identified. Moreover, the local spin density plus U (LSDA+U) method with exchange interaction explicitly included is shown to dramatically overemphasize magnetic interaction.

  5. Drug exposure and psoriasis vulgaris: case-control and case-crossover studies.

    PubMed

    Cohen, Arnon D; Bonneh, Dan Y; Reuveni, Haim; Vardy, Daniel A; Naggan, Lechaim; Halevy, Sima

    2005-01-01

    Intake of drugs is considered a risk factor for psoriasis. The aim of this study was to investigate the association between drugs and psoriasis. A case-control study including 110 patients who were hospitalized for extensive psoriasis was performed. A control group (n = 515) was defined as patients who had undergone elective surgery. A case-crossover study included 98 patients with psoriasis. Exposure to drugs was assessed during a hazard period (3 months before hospitalization) and compared to a control period in the patient's past. Data on drug sales were extracted by data mining techniques. Multivariate analyses were performed by logistic regression and conditional logistic regression. In the case-control study, psoriasis was associated with benzodiazepines (OR 6.9), organic nitrates (OR 5.0), angiotensin-converting enzyme (ACE) inhibitors (OR 4.0) and non-steroidal anti-inflammatory drugs (NSAIDs) (OR 3.7). In the case-crossover study, psoriasis was associated with ACE inhibitors (OR 9.9), beta-blockers (OR 9.9), dipyrone (OR 4.9) and NSAIDs (OR 2.1). Extensive psoriasis may be associated with intake of ACE inhibitors, NSAIDs or beta-blockers. PMID:16191849

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

    PubMed

    van Velzen, Ewoud J J; Westerhuis, Johan A; van Duynhoven, John P M; van Dorsten, Ferdi A; Hoefsloot, Huub C J; Jacobs, Doris M; Smit, Suzanne; Draijer, Richard; Kroner, Christine I; Smilde, Age K

    2008-10-01

    A new method is introduced for the analysis of 'omics' data derived from crossover designed drug or nutritional intervention studies. The method aims at finding systematic variations in metabolic profiles after a drug or nutritional challenge and takes advantage of the crossover design in the data. The method, which can be considered as a multivariate extension of a paired t test, generates different multivariate submodels for the between- and the within-subject variation in the data. A major advantage of this variation splitting is that each submodel can be analyzed separately without being confounded with the other variation sources. The power of the multilevel approach is demonstrated in a human nutritional intervention study which used NMR-based metabolomics to assess the metabolic impact of grape/wine extract consumption. The variations in the urine metabolic profiles are studied between and within the human subjects using the multilevel analysis. After variation splitting, multilevel PCA is used to investigate the experimental and biological differences between the subjects, whereas a multilevel PLS-DA model is used to reveal the net treatment effect within the subjects. The observed treatment effect is validated with cross model validation and permutations. It is shown that the statistical significance of the multilevel classification model ( p < 0.0002) is a major improvement compared to a ordinary PLS-DA model ( p = 0.058) without variation splitting. Finally, rank products are used to determine which NMR signals are most important in the multilevel classification model. PMID:18754629

  7. 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

  8. 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

  9. 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.

  10. Flunarizine as add-on therapy in epilepsy. Crossover study vs placebo.

    PubMed

    Moglia, A; Bergamasco, B; Di Perri, R; Mancia, D

    1986-01-01

    The anticonvulsive effect of flunarizine was studied in a multicenter trial, by means of a randomized, double-blind, single crossover design. The subjects who entered the study were 51 males and 39 females, aged 15 to 73 years. They were epileptic patients who suffered from at least two generalized seizures per month or more than 4 partial seizures per month. The patients were already being treated with major antiepileptic drugs. Flunarizine was administered in a single evening dose of 10 mg/die in patients who weighed less than 70 kg and of 15 mg/die in patients who weighed more 70 kg. Our results show that flunarizine, given as add-on therapy, produced a slight but significant decrease in the number of monthly seizures at the end of a 3-month period, while placebo did not significantly change the seizures frequency. PMID:3301560

  11. 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

  12. 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

  13. 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

  14. 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

  15. Bethe lattice approach and relaxation dynamics study of spin-crossover materials

    NASA Astrophysics Data System (ADS)

    Oke, Toussaint Djidjoho; Hontinfinde, Félix; Boukheddaden, Kamel

    2015-07-01

    Dynamical properties of Prussian blue analogs and spin-crossover materials are investigated in the framework of a Blume-Emery-Griffiths (BEG) spin-1 model, where states ±1 and 0 represent the high-spin (HS) state and the low-spin state, respectively. The quadrupolar interaction depends on the temperature in the form . Magnetic interactions are controlled by a factor such that for (), magnetic ordering is not expected. The model is exactly solved using the Bethe lattice approach for the equilibrium properties. The results are closer to those calculated by numerical simulations with suitable Arrhenius-type transition rates. The study of relaxation processes of non-equilibrium HS states revealed one-step nonlinear sigmoidal relaxation curves of the HS fraction at low temperatures. We found that increasing the magnetic interactions leads to the appearance of a plateau in the thermal hysteresis as well as in the relaxation curves of the HS fraction at low temperature.

  16. 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. PMID:22844342

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

    PubMed Central

    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. PMID:22844342

  18. Repeated Nitrogen Dioxide Exposures and Eosinophilic Airway Inflammation in Asthmatics: A Randomized Crossover Study

    PubMed Central

    Guillossou, Gaëlle; Neukirch, Catherine; Dehoux, Monique; Koscielny, Serge; Bonay, Marcel; Cabanes, Pierre-André; Samet, Jonathan M.; Mure, Patrick; Ropert, Luc; Tokarek, Sandra; Lambrozo, Jacques; Aubier, Michel

    2014-01-01

    Background: Nitrogen dioxide (NO2), a ubiquitous atmospheric pollutant, may enhance the asthmatic response to allergens through eosinophilic activation in the airways. However, the effect of NO2 on inflammation without allergen exposure is poorly studied. Objectives: We investigated whether repeated peaks of NO2, at various realistic concentrations, induce changes in airway inflammation in asthmatics. Methods: Nineteen nonsmokers with asthma were exposed at rest in a double-blind, crossover study, in randomized order, to 200 ppb NO2, 600 ppb NO2, or clean air once for 30 min on day 1 and twice for 30 min on day 2. The three series of exposures were separated by 2 weeks. The inflammatory response in sputum was measured 6 hr (day 1), 32 hr (day 2), and 48 hr (day 3) after the first exposure, and compared with baseline values measured twice 10–30 days before the first exposure. Results: Compared with baseline measurements, the percentage of eosinophils in sputum increased by 57% after exposure to 600 ppb NO2 (p = 0.003) but did not change significantly after exposure to 200 ppb. The slope of the association between the percentage of eosinophils and NO2 exposure level was significant (p = 0.04). Eosinophil cationic protein in sputum was highly correlated with eosinophil count and increased significantly after exposure to 600 ppb NO2 (p = 0.001). Lung function, which was assessed daily, was not affected by NO2 exposure. Conclusions: We observed that repeated peak exposures of NO2 performed without allergen exposure were associated with airway eosinophilic inflammation in asthmatics in a dose-related manner. Citation: Ezratty V, Guillossou G, Neukirch C, Dehoux M, Koscielny S, Bonay M, Cabanes PA, Samet JM, Mure P, Ropert L, Tokarek S, Lambrozo J, Aubier M. 2014. Repeated nitrogen dioxide exposures and eosinophilic airway inflammation in asthmatics: a randomized crossover study. Environ Health Perspect 122:850–855; http://dx.doi.org/10.1289/ehp.1307240 PMID

  19. Baclofen reduces binge eating in a double-blind, placebo-controlled, crossover study.

    PubMed

    Corwin, Rebecca L; Boan, Jarol; Peters, Kathryn F; Ulbrecht, Jan S

    2012-09-01

    Baclofen has shown promise in treating substance use disorders and also reduced binge frequency in an open-label trial. This placebo-controlled, double-blind, crossover study further assessed the effects of baclofen on binge eating. Twelve individuals who self-reported binge eating completed the study. Data were collected during a run-in period (no drug or placebo), placebo phase (48 days), and baclofen phase (titrated up to 60 mg daily or the maximum tolerated dose, 48 days). All the participants were exposed to all conditions. Participants completed a binge diary daily, and the Binge Eating Scale (BES), Food Craving Inventory-II (FCI-II), and Hospital Anxiety and Depression Scale (HADS) at regular intervals throughout the study. Baclofen significantly reduced binge frequency relative to placebo and run-in (P<0.05). This confirms results from the previous open-label trial. Baclofen also produced slight, but significant, increases in depression symptomatology as assessed by the HADS. Binge severity (BES scores) and craving (FCI-II scores) were significantly reduced during placebo and baclofen phases, that is both measures exhibited significant placebo effects. Tiredness, fatigue, and upset stomach were the most commonly reported side-effects. These results indicate that baclofen may be a useful treatment for binge eating in some patients. PMID:22854310

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

    PubMed

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

    2008-11-01

    The purpose of this study was to assess the effect of lento music on examination anxiety among nursing students. A randomized crossover classroom-based trial was conducted. Thirty-eight students with a mean age of 19.4 years (SD = .54) were randomly assigned to either a music/silence or a silence/music group sequence. The students in the music group were given a 40-min group-based music intervention in a classroom, whereas the students in the silence group received the regular test without music. Using paired t-tests, there were no significant different in pretest scores for state anxiety, examination anxiety, finger temperature and pulse rate between the two conditions. Nonetheless, the findings indicated that music intervention did effectively decrease examination anxiety and state anxiety as well as reducing pulse rate and increasing higher finger temperature (p = 0.05 to 0.001). In addition, significant differences were detected between the pretest and posttest measures for silence (p = 0.001). The results suggest that lento music is effective at anxiety reduction. This study provides evidence for nursing faculty and clinical educators to foster nursing students' mastering over the anxiety of examination by using lento music. PMID:18597899

  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. 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

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

    PubMed

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

    2015-01-01

    This work explores the functional and psychosocial impact of the multigrip Michelangelo (M) prosthetic hand. Transradial myoelectric prosthesis users (6 men, median age: 47 y) participated in a crossover longitudinal study. A multifactorial assessment protocol was applied before the application of M and after 3 mo (functional assessment) and 6 mo (psychosocial assessment) of home use. Functional assessment included both practical tests (i.e., Southampton Hand Assessment Procedure [SHAP], Box and Blocks Test [BBT], and Minnesota Manual Dexterity Test [MMDT]) and self-report functional scales. Psychosocial assessment consisted of a clinical interview and a battery of self-report questionnaires concerning current anxious-depressive symptoms and health-related quality of life, body image concerns, adjustment and satisfaction with prosthesis, social support, coping style, and personality. Increased manual dexterity was observed after 3 mo based on improvements in the SHAP, BBT, and MMDT. Two important themes emerged from the clinical interviews at the 6 mo follow-up: (1) the enhanced functionality and (2) the "like a real hand" aspect of the M, which further increased prosthesis integration to the Self. A few patients expressed concerns about M dimension, noise, and weight. The M appeared to restore hand function and natural appearance. The present findings provide preliminary evidence, and additional studies are needed. PMID:26437448

  5. 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.

  6. Quantitative study of ruthenium cross-over in direct methanol fuel cells during early operation hours

    NASA Astrophysics Data System (ADS)

    Schoekel, A.; Melke, J.; Bruns, M.; Wippermann, K.; Kuppler, F.; Roth, C.

    2016-01-01

    In direct methanol fuel cells (DMFC), ruthenium cross-over is an important degradation phenomenon. The loss of ruthenium from the anode, its transport through the membrane and its deposition onto the cathode are detrimental to the fuel cell performance and limit the fuel cell's lifetime. Here we present a quantitative study on the fraction of ruthenium being transferred from the anode to the cathode during early operation hours (0-100 h) of a DMFC. Already during fabrication of the MEA ruthenium is transferred to the cathode. In our pristine MEAs about 0.024 wt% Ru could be found in the cathode catalyst. The cell potential during operation seems to have only a minor influence on the dissolution process. In contrast, the operation time appears to be much more important. Our data hint at two dissolution processes: a fast process dominating the first hours of operation and a slower process, which is responsible for the ongoing ruthenium transfer during the fuel cell lifetime. After 2 h held at open circuit conditions the Ru content of the cathode side was 10 times higher than in the pristine MEA. In contrast, the slower process increased that amount only by a factor of two over the course of another 100 h.

  7. 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

  8. Cross-over study of the efficacy of four beta 2-sympathomimetic bronchodilator aerosols.

    PubMed Central

    Madsen, B W; Tandon, M K; Paterson, J W

    1979-01-01

    1 Bronchodilator efficacy of four beta 2-sympathomimetic aerosols, fenoterol, orciprenaline, salbutamol and terbutaline has been compared in nine patients with chronic stable reversible airways obstruction using a double-blind placebo controlled cross-over design. Two puffs of each agent were given on two separate occasions to each of the patients and the forced expiratory volume in one second (FEV1) and the vital capacity (VC) were measured before and 30, 90, 150 and 210 min after administration. 2 Multivariate analysis of the data at 30 min showed FEV1 and VC in these patients to be so highly correlated that they could be considered as a single variable. 3 When absolute change in VC at 30 min was used as the response criterion, efficacy of the four drugs was significantly better than placebo (P < 0.01). It was not possible to rank all four drugs in order of effectiveness; fenoterol and salbutamol were significantly better than terbutaline and orciprenaline (P < 0.01) but this was complicated by a significant interaction effect between drugs and patients (P < 0.01). 4 Similar results were obtained when absolute and relative changes in FEV1 and VC and area under the curve were used as response variables. 5 The study demonstrates that important individual differences in patient response may be concealed if only average drug effects are considered. PMID:45195

  9. 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

  10. 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.

  11. Therapeutic value of spinal cord stimulation in irritable bowel syndrome: a randomized crossover pilot study.

    PubMed

    Lind, Göran; Winter, Jaleh; Linderoth, Bengt; Hellström, Per M

    2015-05-15

    Irritable bowel syndrome (IBS) is characterized by abdominal pain and changed bowel habits. Spinal cord stimulation (SCS) has been used for treatment of chronic pain syndromes. Animal studies have shown SCS to reduce the reaction to colonic balloon distension, known to be increased in IBS patients. To elucidate the potential for SCS as treatment for IBS, a pilot study was performed. Ten IBS patients (age 26-56 yr) were recruited. A SCS system with a four-polar electrode was implanted at the T5-T8 level. After a 2-wk run-in, a randomized, crossover design SCS during 6 wk was compared with no stimulation, with an ensuing stimulation period for 12 wk; total study period 28 wk. Patients recorded pain level, pain attacks, diarrheas, and global quality of life in a diary. At end of the study patients could choose to retain their SCS system or have it removed. Nine patients completed the whole trial. During stimulation periods the median pain scores were significantly reduced from visual analogue scale (VAS) 7 (4-8) to 3 (2.5-7) and to 4 (2-6) during early and late stimulation periods, respectively (P < 0.03-0.04). Pain attacks were numerically reduced. A few patients reported reduced number of diarrheas. After study termination, six patients chose to retain their SCS system. To conclude, SCS is a minimally invasive treatment option for pain in IBS. With SCS the pain level was reduced though with merely a trend for number of attacks and diarrheas. The efficacy of SCS in IBS pain indicates a possible usefulness in other painful bowel disorders. PMID:25786486

  12. Impaired glucose tolerance after brief heat exposure: a randomized crossover study in healthy young men.

    PubMed

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

    2016-06-01

    A high demand on thermoregulatory processes may challenge homoeostasis, particularly regarding glucose regulation. This has been understudied, although it might concern millions of humans. The objective of this project was to examine the isolated and combined effects of experimental short-term mild heat exposure and metabolic level on glucoregulation. Two experimental randomized crossover studies were conducted. Ten healthy young men participated in study A, which comprises four sessions in a fasting state at two metabolic levels [rest and exercise at 60% of maximal oxygen uptake (O2) for 40 min] in two environmental temperatures (warm: 31°C and control: 22°C). Each session ended with an ad libitum meal, resulting in similar energy intake across sessions. In study B, 12 healthy young men underwent two 3 h oral glucose tolerance tests (OGTTs) in warm and control environmental temperatures. Venous blood was sampled at several time points. In study A, repeated measure ANOVAs revealed higher postprandial serum glucose and insulin levels with heat exposure. Glycaemia following the OGTT was higher in the warm temperature compared with control. The kinetics of the serum glucose response to the glucose load was also affected by the environmental temperature (temperature-by-time interaction, P=0.030), with differences between the warm and control conditions observed up to 90 min after the glucose load (all P<0.033). These studies provide evidence that heat exposure alters short-term glucoregulation. The implication of this environmental factor in the physiopathology of Type 2 diabetes has yet to be investigated. PMID:26980346

  13. An innovative acupuncture treatment for primary dysmenorrhea: a randomized cross-over pilot study

    PubMed Central

    Wade, Christine M.; Abercrombie, Priscilla D.; Gomolak, Denise

    2013-01-01

    Background/Objective Dysmenorrhea is highly prevalent among adolescent women and a major cause of activity restriction. Standard pharmaceuticals used to treat dysmenorrhea are not effective for all women and have side effects that limit their use. Our study objective was to examine feasibility, acceptability, and preliminary effects of acupuncture point injection of vitamin K1 as an alternative treatment for primary dysmenorrhea among US women. Methods/Design We conducted a pilot study using a crossover trial design. Women with primary dysmenorrhea were randomized to receive vitamin K1 injection in the Spleen-6 acupuncture point at the start of menstruation followed by saline in a non-acupuncture point after two months, or the reverse order of treatments. Setting/Participants The study was conducted in the San Francisco Bay Area among women 18 and 25 years of age diagnosed with primary dysmenorrhea; fourteen women completed all study visits. Primary Outcome Measure Dysmenorrhea pain intensity was measured using a 0–10 numeric rating scale before and after injections. Results Women had an average 2.5 point decrease in pain after vitamin K1 injection in Spleen-6 (p < 0.001) compared with a 1.8 point decrease after saline (p < 0.001). Change scores of vitamin K1 compared with saline injection approached statistical significance (p < 0.10). Intensity and duration of menstrual symptoms measured by the Cox Retrospective Symptom Score also decreased following injections. After participating, 94% would still agree to go through with the injection therapy and 77% reported they would come every month were the treatment available. Conclusions Findings suggest high acceptability of acupuncture point injection of vitamin K1 as treatment for primary dysmenorrhea among young women in San Francisco. Pain decreased with both treatments, with a trend toward greater pain reduction for vitamin K1/Spleen-6 injection. This is consistent with outcomes from the Obstetrics & Gynecology

  14. 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

  15. 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

  16. 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

  17. 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

  18. A Case-Crossover Study of Sleep and Work Hours and the Risk of Road Traffic Accidents

    PubMed Central

    Valent, Francesca; Di Bartolomeo, Stefano; Marchetti, Riccardo; Sbrojavacca, Rodolfo; Barbone, Fabio

    2010-01-01

    Study Objectives: Sleepiness, prolonged wakefulness, and extended work hours have been associated with increased risk of injuries and road accidents. The authors' objective was to study the relation between those factors and road accidents using a case-crossover design, effective in estimating the risk of acute events associated with transient, short effect exposures. Design: Five hundred seventy-four injured drivers presenting for care after road accidents to the Emergency Room of Udine, Italy, were enrolled in the study from March 2007 to March 2008. Sleep, work, and driving patterns in the 48 h before the accident were assessed through an interview. Measurements and Results: The relative risk (RR) of accident associated with each exposure was estimated using the case-crossover matched pair interval approach. Sleeping ≥ 11 h daily was associated with a decrease of the RR, as was sleeping less than usual. Being awake ≥ 16 h and, possibly, working > 12 h daily were associated with increases in the RR. Conclusions: Extended work hours and prolonged wakefulness increase the risk of road accidents and suggest that awareness should be raised among drivers. The findings regarding acute sleep amount are less clear, possibly due to an effect of chronic sleep loss. Citation: Valent F; Di Bartolomeo S; Marchetti R; Sbrojavacca R; Barbone F. A case-crossover study of sleep and work hours and the risk of road traffic accidents. SLEEP 2010;33(3):349-354. PMID:20337193

  19. 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…

  20. 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. PMID:8241527

  1. 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. PMID:26148559

  2. Air pollution, asthma attacks, and socioeconomic deprivation: a small-area case-crossover study.

    PubMed

    Laurent, Olivier; Pedrono, Gaëlle; Segala, Claire; Filleul, Laurent; Havard, Sabrina; Deguen, Séverine; Schillinger, Charles; Rivière, Emmanuel; Bard, Denis

    2008-07-01

    With few exceptions, studies of short-term health effects of air pollution use pollutant concentrations that are averaged citywide as exposure indicators. They are thus prone to exposure misclassification and consequently to bias. Measurement of the relations between air pollution and health, generally and in specific populations, could be improved by employing more geographically precise exposure estimates. The authors investigated short-term relations between ambient air pollution estimated in small geographic areas (French census blocks) and asthma attacks in Strasbourg, France, in 2000-2005--in the general population and in populations with contrasting levels of socioeconomic deprivation. Emergency health-care networks provided data on 4,683 telephone calls made for asthma attacks. Deprivation was estimated using a block-level index constructed from census data. Hourly concentrations of particulate matter less than 10 microm in aerodynamic diameter (PM(10)), sulfur dioxide, nitrogen dioxide, and ozone were modeled by block with ADMS-Urban software. Adjusted case-crossover analyses showed that asthma calls were positively but not significantly associated with PM(10) (for a 10-microg x m(-3) increase, odds ratio (OR) = 1.035, 95% confidence interval (CI): 0.997, 1.075), sulfur dioxide (OR = 1.056, 95% CI: 0.979, 1.139), and nitrogen dioxide (OR = 1.025, 95% CI: 0.990, 1.062). No association was observed for ozone (OR = 0.998, 95% CI: 0.965, 1.032). Socioeconomic deprivation had no significant influence on these relations. PMID:18467319

  3. Triggering of stroke by ambient temperature variation: A case-crossover study in Maputo, Mozambique

    PubMed Central

    Gomes, Joana; Damasceno, Albertino; Carrilho, Carla; Lobo, Vitória; Lopes, Hélder; Madede, Tavares; Pravinrai, Pius; Silva-Matos, Carla; Diogo, Domingos; Azevedo, Ana; Lunet, Nuno

    2015-01-01

    Objectives The effect of ambient temperature as a stroke trigger is likely to differ by type of stroke and to depend on non-transient exposures that influence the risk of this outcome. We aimed to quantify the association between ambient temperature variation and stroke, according to clinical characteristics of the events, and other risk factors for stroke. Methods We conducted a case-crossover study based on a 1-year registry of the hospital admissions due to newly occurring ischemic and hemorrhagic stroke events in Maputo, Mozambique's capital city (N = 593). The case-period was defined as the 7 days before the stroke event, which was compared to two control periods (14–21 days and 21–28 days before the event). We computed humidity- and precipitation-adjusted odds ratios (OR) and 95% confidence intervals (95%CI) using conditional logistic regression. Results An association between minimum temperature declines higher than 2.4 °C in any two consecutive days in the previous week and the occurrence of stroke was observed only for first events (OR = 1.43, 95%CI: 1.15–1.76). Stronger and statistically significant associations were observed for hemorrhagic stroke (OR = 1.50, 95%CI: 1.07–2.09) and among subjects not exposed to risk factors, including smoking, high serum cholesterol or atrial fibrillation. No differences in the effect of temperature were found according to the patients’ vital status 28 days after the event. Conclusions First stroke events, especially of the hemorrhagic type, were triggered by declines in the minimum temperature between consecutive days of the preceding week. PMID:25559679

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

    PubMed Central

    2014-01-01

    Background The effects of tongue cleaning on reconstruction of bacterial flora in dental plaque and tongue coating itself are obscure. We assessed changes in the amounts of total bacteria as well as Fusobacterium nucleatum in tongue coating and dental plaque specimens obtained with and without tongue cleaning. Methods We conducted a randomized examiner-blind crossover study using 30 volunteers (average 23.7 ± 3.2 years old) without periodontitis. After dividing randomly into 2 groups, 1 group was instructed to clean the tongue, while the other did not. On days 1 (baseline), 3, and 10, tongue coating and dental plaque samples were collected after recording tongue coating score (Winkel tongue coating index: WTCI). After a washout period of 3 weeks, the same examinations were performed with the subjects allocated to the alternate group. Genomic DNA was purified from the samples and applied to SYBR® Green-based real-time PCR to quantify the amounts of total bacteria and F. nucleatum. Results After 3 days, the WTCI score recovered to baseline, though the amount of total bacteria in tongue coating was significantly lower as compared to the baseline. In plaque samples, the bacterial amounts on day 3 and 10 were significantly lower than the baseline with and without tongue cleaning. Principal component analysis showed that variations of bacterial amounts in the tongue coating and dental plaque samples were independent from each other. Furthermore, we found a strong association between amounts of total bacteria and F. nucleatum in specimens both. Conclusions Tongue cleaning reduced the amount of bacteria in tongue coating. However, the cleaning had no obvious contribution to inhibit dental plaque formation. Furthermore, recovery of the total bacterial amount induced an increase in F. nucleatum in both tongue coating and dental plaque. Thus, it is recommended that tongue cleaning and tooth brushing should both be performed for promoting oral health. PMID:24423407

  5. Prophylactic treatment of migraine with angiotensin converting enzyme inhibitor (lisinopril): randomised, placebo controlled, crossover study

    PubMed Central

    Schrader, Harald; Stovner, Lars Jacob; Helde, Grethe; Sand, Trond; Bovim, Gunnar

    2001-01-01

    Objective To determine the efficacy of an angiotensin converting enzyme inhibitor in the prophylaxis of migraine. Design Double blind, placebo controlled, crossover study. Setting Neurological outpatient clinic. Participants Sixty patients aged 19-59 years with migraine with two to six episodes a month. Interventions Treatment period of 12 weeks with one 10 mg lisinopril tablet once daily for one week then two 10 mg lisinopril tablets once daily for 11 weeks, followed by a two week wash out period. Second treatment period of one placebo tablet once daily for one week and then two placebo tablets for 11 weeks. Thirty participants followed this schedule, and 30 received placebo followed by lisinopril. Main outcome measures Primary end points: number of hours with headache, number of days with headache, number of days with migraine. Secondary end points: headache severity index, use of drugs for symptomatic relief, quality of life and number of days taken as sick leave, acceptability of treatment. Results In the 47 participants with complete data, hours with headache, days with headache, days with migraine, and headache severity index were significantly reduced by 20% (95% confidence interval 5% to 36%), 17% (5% to 30%), 21% (9% to 34%), and 20% (3% to 37%), respectively, with lisinopril compared with placebo. Days with migraine were reduced by at least 50% in 14 participants for active treatment versus placebo and 17 patients for active treatment versus run-in period. Days with migraine were fewer by at least 50% in 14 participants for active treatment versus placebo. Intention to treat analysis of data from 55 patients supported the differences in favour of lisinopril for the primary end points. Conclusion The angiotensin converting enzyme inhibitor, lisinopril, has a clinically important prophylactic effect in migraine. PMID:11141144

  6. Study of. lambda. parameters and crossover phenomena in SU(N) x SU(N) sigma models in two dimensions

    SciTech Connect

    Shigemitsu, J; Kogut, J B

    1981-01-01

    The spin system analogues of recent studies of the string tension and ..lambda.. parameters of SU(N) gauge theories in 4 dimensions are carried out for the SU(N) x SU(N) and O(N) models in 2 dimensions. The relations between the ..lambda.. parameters of both the Euclidean and Hamiltonian formulation of the lattice models and the ..lambda.. parameter of the continuum models are obtained. The one loop finite renormalization of the speed of light in the lattice Hamiltonian formulations of the O(N) and SU(N) x SU(N) models is calculated. Strong coupling calculations of the mass gaps of these spin models are done for all N and the constants of proportionality between the gap and the ..lambda.. parameter of the continuum models are obtained. These results are contrasted with similar calculations for the SU(N) gauge models in 3+1 dimensions. Identifying suitable coupling constants for discussing the N ..-->.. infinity limits, the numerical results suggest that the crossover from weak to strong coupling in the lattice O(N) models becomes less abrupt as N increases while the crossover for the SU(N) x SU(N) models becomes more abrupt. The crossover in SU(N) gauge theories also becomes more abrupt with increasing N, however, at an even greater rate than in the SU(N) x SU(N) spin models.

  7. 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

  8. 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

  9. Acute Effects of Hemodiafiltration Versus Conventional Hemodialysis on Endothelial Function and Inflammation: A Randomized Crossover Study.

    PubMed

    Jia, Ping; Jin, Wei; Teng, Jie; Zhang, Hao; Zou, Jianzhou; Liu, Zhonghua; Shen, Bo; Cao, Xuesen; Ding, Xiaoqiang

    2016-04-01

    Endothelial dysfunction and chronic inflammatory process are prevalent in patients with end-stage renal disease (ESRD) on maintenance hemodialysis (HD). The aim of this study was to evaluate the acute and short-term effects of online hemodiafiltration (OL-HDF) versus conventional HD on endothelial function and inflammation.A prospective, randomized, crossover trial.Twenty stable ESRD patients undergoing chronic HD treatments were randomly assigned with a 1:1 ratio to conventional HD and to OL-HDF both for 2 weeks (either HD followed by OL-HDF or OL-HDF followed by HD). Markers of endothelial dysfunction such as flow-mediated dilatation (FMD) of the brachial artery, soluble endothelial protein C receptor (sEPCR), and soluble thrombomodulin (sTM) were measured at baseline, after the first dialysis session and after 2 weeks. Meanwhile, serum interleukin 6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP) levels were measured as well.Both a single OL-HDF session and 2-week OL-HDF significantly improved brachial FMD% (18.7 ± 6.9% at baseline; 21.5 ± 5.4% after the first dialysis; 21.5 ± 5.7% after 2 weeks; P < 0.05 vs baseline), decreased the levels of sEPCR (from 394.4 [297.9-457.0] ng/ml at baseline to 234.7 [174.1-345.5] ng/ml after the first dialysis, and to 191.5 [138.2-255.0] ng/ml after 2 weeks; P < 0.01 vs baseline) and sTM. In contrast, HD did not change FMD%, even increased the levels of sEPCR and sTM. A reduction in IL-6 level was observed in OL-HDF patients after 2-week dialysis, while IL-6 did not change in HD patients. There was no significant difference in change of hs-CRP level between the OL-HDF and HD treatments.OL-HDF has both acute and short-term beneficial effects on endothelial dysfunction compared to conventional HD. PMID:27100440

  10. 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.

  11. 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

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

    NASA Astrophysics Data System (ADS)

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

    2014-11-01

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

  13. 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

  14. 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. PMID:22676368

  15. 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.

  16. 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

  17. 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

  18. A randomized, crossover design study of sevelamer carbonate powder and sevelamer hydrochloride tablets in chronic kidney disease patients on haemodialysis

    PubMed Central

    Fan, Stanley; Ross, Calum; Mitra, Sandip; Kalra, Philip; Heaton, Jeremy; Hunter, John; Plone, Melissa; Pritchard, Nick

    2009-01-01

    Background. Sevelamer carbonate is an improved, buffered form of sevelamer hydrochloride developed for the treatment of hyperphosphataemia in CKD patients. Sevelamer carbonate formulated as a powder for oral suspension presents a novel, patient-friendly alternative to tablet phosphate binders. This study compared the safety and efficacy of sevelamer carbonate powder with sevelamer hydrochloride tablets in CKD patients on haemodialysis. Methods. This was a multi-centre, open-label, randomized, crossover design study. Thirty-one haemodialysis patients were randomly assigned to either sevelamer carbonate powder or sevelamer hydrochloride tablets for 4 weeks followed by a crossover to the other regimen for an additional 4 weeks. Results. The mean serum phosphorus was 1.6 ± 0.5 mmol/L (5.0 ± 1.5 mg/dL) during sevelamer carbonate powder treatment and 1.7 ± 0.4 mmol/L (5.2 ± 1.1 mg/dL) during sevelamer hydrochloride tablet treatment. Sevelamer carbonate powder and sevelamer hydrochloride tablets are equivalent in controlling serum phosphorus; the geometric least square mean ratio was 0.95 (90% CI 0.87–1.03). No statistically significant or clinically meaningful differences were observed in calcium × phosphorus product and lipid levels between sevelamer carbonate powder and sevelamer hydrochloride tablets. Serum bicarbonate levels increased 2.7 ± 3.7 mmol/L (2.7 ± 3.7 mEq/L) during sevelamer carbonate treatment. No statistically significant change in bicarbonate was observed during sevelamer hydrochloride treatment. Sevelamer carbonate powder and sevelamer hydrochloride were well tolerated during this study. Conclusions. Sevelamer carbonate powder and sevelamer hydrochloride tablets are equivalent in controlling serum phosphorus and well tolerated in CKD patients on haemodialysis. Bicarbonate levels improved only during sevelamer carbonate treatment. Sevelamer carbonate powder should provide a welcomed new option for the treatment of hyperphosphataemia for CKD

  19. Antiseptic Body Washes for Reducing the Transmission of Methicillin-Resistant Staphylococcus aureus: A Cluster Crossover Study.

    PubMed

    Harris, Patrick N A; Le, Bich Diep; Tambyah, Paul; Hsu, Li Yang; Pada, Surinder; Archuleta, Sophia; Salmon, Sharon; Mukhopadhyay, Amartya; Dillon, Jasmine; Ware, Robert; Fisher, Dale A

    2015-04-01

    Background.  Limiting the spread of methicillin-resistant Staphylococcus aureus (MRSA) within healthcare facilities where the organism is highly endemic is a challenge. The use of topical antiseptic agents may help interrupt the transmission of MRSA and reduce the risk of clinical infection. Octenidine dihydrochloride is a topical antiseptic that exhibits in vitro efficacy against a wide variety of bacteria, including S aureus. Methods.  We conducted a prospective cluster crossover study to compare the use of daily octenidine body washes with soap and water in patients identified by active surveillance cultures to be MRSA-colonized, to prevent the acquisition of MRSA in patients with negative screening swabs. Five adult medical and surgical wards and 2 intensive care units were selected. The study involved an initial 6-month phase using octenidine or soap washes followed by a crossover in each ward to the alternative product. The primary and secondary outcomes were the rates of new MRSA acquisitions and MRSA clinical infections, respectively. Results.  A total of 10 936 patients admitted for ≥48 hours was included in the analysis. There was a small reduction in MRSA acquisition in the intervention group compared with controls (3.0% vs 3.3%), but this reduction was not significant (odds ratio, 0.89; 95% confidence interval, .72-1.11; P = .31). There were also no significant differences in clinical MRSA infection or incidence of MRSA bacteremia. Conclusions.  This study suggests that the targeted use of routine antiseptic washes may not in itself be adequate to reduce the transmission of MRSA in an endemic hospital setting. PMID:26125031

  20. Antiseptic Body Washes for Reducing the Transmission of Methicillin-Resistant Staphylococcus aureus: A Cluster Crossover Study

    PubMed Central

    Harris, Patrick N. A.; Le, Bich Diep; Tambyah, Paul; Hsu, Li Yang; Pada, Surinder; Archuleta, Sophia; Salmon, Sharon; Mukhopadhyay, Amartya; Dillon, Jasmine; Ware, Robert; Fisher, Dale A.

    2015-01-01

    Background. Limiting the spread of methicillin-resistant Staphylococcus aureus (MRSA) within healthcare facilities where the organism is highly endemic is a challenge. The use of topical antiseptic agents may help interrupt the transmission of MRSA and reduce the risk of clinical infection. Octenidine dihydrochloride is a topical antiseptic that exhibits in vitro efficacy against a wide variety of bacteria, including S aureus. Methods. We conducted a prospective cluster crossover study to compare the use of daily octenidine body washes with soap and water in patients identified by active surveillance cultures to be MRSA-colonized, to prevent the acquisition of MRSA in patients with negative screening swabs. Five adult medical and surgical wards and 2 intensive care units were selected. The study involved an initial 6-month phase using octenidine or soap washes followed by a crossover in each ward to the alternative product. The primary and secondary outcomes were the rates of new MRSA acquisitions and MRSA clinical infections, respectively. Results. A total of 10 936 patients admitted for ≥48 hours was included in the analysis. There was a small reduction in MRSA acquisition in the intervention group compared with controls (3.0% vs 3.3%), but this reduction was not significant (odds ratio, 0.89; 95% confidence interval, .72–1.11; P = .31). There were also no significant differences in clinical MRSA infection or incidence of MRSA bacteremia. Conclusions. This study suggests that the targeted use of routine antiseptic washes may not in itself be adequate to reduce the transmission of MRSA in an endemic hospital setting. PMID:26125031

  1. The effect of music on discomfort experienced by intensive care unit patients during turning: a randomized cross-over study.

    PubMed

    Cooke, Marie; Chaboyer, Wendy; Schluter, Philip; Foster, Michelle; Harris, Denise; Teakle, Roz

    2010-04-01

    Research consistently demonstrates that intensive care unit (ICU) patients experience pain, discomfort and anxiety despite analgesic and sedative use. The most painful procedure reported by critically ill patients is being turned. Music diminishes anxiety and discomfort in some populations; however, its effect on critically ill patients remains unknown. This research aimed to identify the effect of music on discomfort experienced by ICU patients during turning using a single blind randomized cross-over design. Seventeen post-operative ICU patients were recruited and treatment order randomized. Discomfort and anxiety were measured 15 min before and immediately after two turning procedures. Findings indicated that listening to music 15 min before and during turning did not significantly reduce discomfort or anxiety. Pain management might effectively be addressing discomfort and anxiety experienced during turning. Given previous studies have identified turning as painful, current results are promising and it might be useful to determine if this is widespread. PMID:20487057

  2. Becoming a crossover-competent DSB.

    PubMed

    Lake, Cathleen M; Hawley, R Scott

    2016-06-01

    The proper execution of meiotic recombination (or crossing over) is essential for chromosome segregation during the first meiotic division, and thus this process is regulated by multiple, and often elaborate, mechanisms. Meiotic recombination begins with the programmed induction of DNA double-strand breaks (DSBs), of which only a subset are selected to be repaired into crossovers. This crossover selection process is carried out by a number of pro-crossover proteins that regulate the fashion in which DSBs are repaired. Here, we highlight recent studies regarding the process of DSB fate selection by a family of pro-crossover proteins known as the Zip-3 homologs. PMID:26806636

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

    PubMed Central

    2011-01-01

    Background Air pollution from vehicular traffic has been associated with respiratory diseases. In Palermo, the largest metropolitan area in Sicily, urban air pollution is mainly addressed to traffic-related pollution because of lack of industrial settlements, and the presence of a temperate climate that contribute to the limited use of domestic heating plants. This study aimed to investigate the association between traffic-related air pollution and emergency room admissions for acute respiratory symptoms. Methods From January 2004 through December 2007, air pollutant concentrations and emergency room visits were collected for a case-crossover study conducted in Palermo, Sicily. Risk estimates of short-term exposures to particulate matter and gaseous ambient pollutants including carbon monoxide, nitrogen dioxide, and sulfur dioxide were calculated by using a conditional logistic regression analysis. Results Emergency departments provided data on 48,519 visits for respiratory symptoms. Adjusted case-crossover analyses revealed stronger effects in the warm season for the most part of the pollutants considered, with a positive association for PM10 (odds ratio = 1.039, 95% confidence interval: 1.020 - 1.059), SO2 (OR = 1.068, 95% CI: 1.014 - 1.126), nitrogen dioxide (NO2: OR = 1.043, 95% CI: 1.021 - 1.065), and CO (OR = 1.128, 95% CI: 1.074 - 1.184), especially among females (according to an increase of 10 μg/m3 in PM10, NO2, SO2, and 1 mg/m3 in CO exposure). A positive association was observed either in warm or in cold season only for PM10. Conclusions Our findings suggest that, in our setting, exposure to ambient levels of air pollution is an important determinant of emergency room (ER) visits for acute respiratory symptoms, particularly during the warm season. ER admittance may be considered a good proxy to evaluate the adverse effects of air pollution on respiratory health. PMID:21489245

  4. 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

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

    PubMed Central

    2012-01-01

    Background Environmental pollution is a known risk factor for multiple diseases and furthermore increases rate of hospitalisations. We investigated the correlation between emergency room admissions (ERAs) of the general population for respiratory diseases and the environmental pollutant levels in Milan, a metropolis in northern Italy. Methods We collected data from 45770 ERAs for respiratory diseases. A time-stratified case-crossover design was used to investigate the association between air pollution levels and ERAs for acute respiratory conditions. The effects of air pollutants were investigated at lag 0 to lag 5, lag 0–2 and lag 3–5 in both single and multi-pollutant models, adjusted for daily weather variables. Results An increase in ozone (O3) levels at lag 3–5 was associated with a 78% increase in the number of ERAs for asthma, especially during the warm season. Exposure to carbon monoxide (CO) proved to be a risk factor for pneumonia at lag 0–2 and in the warm season increased the risk of ERA by 66%. A significant association was found between ERAs for COPD exacerbation and levels of sulphur dioxide (SO2), CO, nitrate dioxide (NO2), and particulate matter (PM10 and PM2.5). The multipollutant model that includes all pollutants showed a significant association between CO (26%) and ERA for upper respiratory tract diseases at lag 0–2. For chronic obstructive pulmonary disease (COPD) exacerbations, only CO (OR 1.19) showed a significant association. Conclusions Exposure to environmental pollution, even at typical low levels, can increase the risk of ERA for acute respiratory diseases and exacerbation of obstructive lung diseases in the general population. PMID:23078274

  6. Effects of alfuzosin and tamsulosin on sperm parameters in healthy men: results of a short-term, randomized, double-blind, placebo-controlled, crossover study.

    PubMed

    Hellstrom, Wayne J G; Sikka, Suresh C

    2009-01-01

    Ejaculation disorders are associated with tamsulosin treatment for lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH). To assess whether tamsulosin has any effect on semen, sperm parameters were evaluated in healthy men receiving tamsulosin, alfuzosin, and placebo. Forty-eight healthy men received 5 days of tamsulosin 0.8 mg once daily (QD), alfuzosin 10 mg QD, and placebo in a randomized, double-blind, 3-way crossover study with a 10-14-day washout period between treatments. The changes (x +/- SE) from baseline in semen sperm concentration, semen sperm count, semen viscosity, semen fructose, sperm motility, and sperm morphology on day 5 of treatment were assessed. The change from baseline in semen sperm concentration was 3.1 +/- 8.3 million/mL with tamsulosin, 15.0 +/- 6.5 million/mL with alfuzosin, and 24.4 +/- 6.5 million/mL with placebo. The total sperm count in semen decreased from baseline with tamsulosin (-54.6 +/- 24.0 million) but not with placebo (81.5 +/- 18.8 million) or alfuzosin (46.2 +/- 19.0 million). The percentage of men with normal semen viscosity was lower with tamsulosin (65%) than with placebo (98%) or alfuzosin (92%). The change from baseline in semen fructose was comparable for all treatments. The percentage of motile sperm decreased 13.8% from baseline to day 5 of treatment with tamsulosin compared with decreases of 2.3% with placebo and 0.4% with alfuzosin. The percentage of abnormal sperm increased marginally with tamsulosin (0.6%) but not with placebo (-2.8%) or alfuzosin (-3.9%). The most common adverse events were dizziness (alfuzosin 11%, tamsulosin 14%, placebo 0%) and orthostatic hypotension (alfuzosin 25%, tamsulosin 11%, placebo 5%). The results suggest that tamsulosin has a negative effect on sperm in healthy men. Studies on the effects of alpha(1)-adrenergic blockers on sperm in men with BPH are warranted. PMID:19201696

  7. 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

  8. 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

  9. 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

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

    PubMed

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

    2016-01-01

    Hyper-heuristics are high-level methodologies for solving complex problems that operate on a search space of heuristics. In a selection hyper-heuristic framework, a heuristic is chosen from an existing set of low-level heuristics and applied to the current solution to produce a new solution at each point in the search. The use of crossover low-level heuristics is possible in an increasing number of general-purpose hyper-heuristic tools such as HyFlex and Hyperion. However, little work has been undertaken to assess how best to utilise it. Since a single-point search hyper-heuristic operates on a single candidate solution, and two candidate solutions are required for crossover, a mechanism is required to control the choice of the other solution. The frameworks we propose maintain a list of potential solutions for use in crossover. We investigate the use of such lists at two conceptual levels. First, crossover is controlled at the hyper-heuristic level where no problem-specific information is required. Second, it is controlled at the problem domain level where problem-specific information is used to produce good-quality solutions to use in crossover. A number of selection hyper-heuristics are compared using these frameworks over three benchmark libraries with varying properties for an NP-hard optimisation problem: the multidimensional 0-1 knapsack problem. It is shown that allowing crossover to be managed at the domain level outperforms managing crossover at the hyper-heuristic level in this problem domain. PMID:25635698

  11. 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

  12. 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

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

    PubMed

    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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. Ambient Heat and Sudden Infant Death: A Case-Crossover Study Spanning 30 Years in Montreal, Canada

    PubMed Central

    Fraser, William D.; Smargiassi, Audrey; Kosatsky, Tom

    2015-01-01

    Background Climate change may lead to more severe and extreme heat waves in the future, but its potential impact on sudden infant death—a leading cause of infant mortality—is unclear. Objectives We sought to determine whether risk of sudden infant death syndrome (SIDS) is elevated during hot weather. Methods We undertook a case-crossover analysis of all sudden infant deaths during warm periods in metropolitan Montreal, Quebec, Canada, from 1981 through 2010. Our analysis included a total of 196 certified cases of SIDS, including 89 deaths at 1–2 months of age, and 94 at 3–12 months. We estimated associations between maximum outdoor temperatures and SIDS by comparing outdoor temperatures on the day of or day before a SIDS event with temperatures on control days during the same month, using cubic splines to model temperature and adjusting for relative humidity. Results Maximum daily temperatures of ≥ 29°C on the same day were associated with 2.78 times greater odds of sudden infant death relative to 20°C (95% CI: 1.64, 4.70). The likelihood of sudden death increased steadily with higher temperature. Associations were stronger for infants 3–12 months of age than for infants 1–2 months of age, with odds ratios of 3.90 (95% CI: 1.87, 8.13) and 1.73 (95% CI: 0.80, 3.73), respectively, for 29°C compared with 20°C on the day of the event. Conclusions High ambient temperature may be a novel risk factor for SIDS, especially at ≥ 3 months of age. Climate change and the higher temperatures that result may account for a potentially greater proportion of sudden infant deaths in the future. Citation Auger N, Fraser WD, Smargiassi A, Kosatsky T. 2015. Ambient heat and sudden infant death: a case-crossover study spanning 30 years in Montreal, Canada. Environ Health Perspect 123:712–716; http://dx.doi.org/10.1289/ehp.1307960 PMID:25748025

  20. 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

  1. The bioavailability of Tamoplex (tamoxifen). Part 2. A single dose cross-over study in healthy male volunteers.

    PubMed

    Guelen, P J; Stevenson, D; Briggs, R J; de Vos, D

    1987-10-01

    Tamoxifen and N-desmethyltamoxifen plasma concentrations were determined in a single dose cross-over study with Tamoplex and Nolvadex at the dose height of 40 mg in 18 healthy male volunteers with a wash-out period of at least 140 days. ANOVA, power analysis and novel bioequivalence tests on AUC, Cmax and tcmax, including a non-parametric one, demonstrated bioequivalence of Tamoplex and Nolvadex 10 mg tablets. The mean AUC ( +/- SD) values of tamoxifen after administration of Tamoplex or Nolvadex tablets were 1076 +/- 265 and 1131 +/- 301 h ng ml-1, respectively. ANOVA on the AUC values gave a p value of 0.450 with a power of 0.85 and a 95% confidence interval of 81.8-108.5% was obtained. The 0.8 power test showed a determined difference of 18.9%, whereas the actual difference was 4.9%. Interindividual and intraindividual variation was assessed. The pharmacokinetic data, well established for 34 hr, constitute a basis for further studies on tamoxifen distribution, elimination and metabolism. PMID:3441162

  2. A randomized crossover study investigating the influence of ranitidine or omeprazole on the pharmacokinetics of cephalexin monohydrate.

    PubMed

    Madaras-Kelly, Karl; Michas, Patricia; George, Molly; May, Matthew P; Adejare, Adeboye

    2004-12-01

    Limited data characterize pharmacokinetic interactions between cephalexin and ranitidine, and no data exist for an interaction with proton pump inhibitors. The purpose of this study was to investigate the effects of ranitidine or omeprazole administration on the pharmacokinetics and pharmacodynamics of cephalexin. A randomized single- and multiple-dose crossover study was conducted in healthy subjects ingesting cephalexin before and after steady-state administration of ranitidine or omeprazole. Time-concentration profiles were determined and pharmacokinetic parameters were characterized using noncompartmental methods. Pharmacokinetic data were analyzed in accordance with the two 1-sided test for bioequivalence. The percentage of time that serum concentrations remain above the MIC(90) during the dosing interval (T > MIC(90)) for Streptococcus pyogenes and Staphylococcus aureus associated with the pharmacokinetic profiles was calculated. The coadministration of cephalexin with ranitidine or omeprazole resulted in relatively minor changes in C(max), AUC(infinity), t(1/2), or CL/F. t(max) was significantly prolonged when cephalexin was administered with ranitidine or omeprazole. Suboptimal T > MIC(90) was observed for cephalexin irrespective of acid suppression. Delay in absorption of cephalexin resulted in a decrease in the percentage of T > MIC(90) for certain acid-suppressive regimens and pathogen combinations. With the exception of an increase in t(max), there were no significant pharmacokinetic interactions between cephalexin and ranitidine or omeprazole. Delayed t(max) associated with acid suppression may result in a diminished T > MIC(90). PMID:15545310

  3. 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

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

    PubMed Central

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

    2014-01-01

    Background The combination of milbemycin oxime–praziquantel is widely used against the most common tapeworms and roundworms affecting cats. New veterinary presentations of this combination have recently been approved. Objective The objective of this study was to compare the palatability of two products using this combination, Milpro® and Milbemax®. Methods In all, 20 adult cats and 20 kittens were offered each product according to a randomisation table using a blinded crossover design. Prehension from the bowl, prehension from the hand and total consumption were assessed. Results Both presentations were very well tolerated in adult cats and kittens. Total prehension in adult cats and kittens was 100 and 45 per cent, respectively, for Milpro®, and 95 and 30 per cent, respectively, for Milbemax®. The percentages of adult cats and kittens which swallowed the pill after taking it into their mouth (total spontaneous consumption) were respectively 40 and 45 per cent for Milpro®, and 35 and 20 per cent for Milbemax®. Conclusion In this study, both presentations were highly attractive to cats and their respective coatings successfully covered the unpleasant odour of praziquantel, which usually repels cats. These results indicate that the palatability of Milpro® is at least as good as Milbemax® and both tablets are well accepted by adult cats and kittens. PMID:26392882

  5. 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

  6. 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. PMID:26934896

  7. Spin crossover transition of Fe(phen)2(NCS)2: periodic dispersion-corrected density-functional study.

    PubMed

    Bučko, Tomáš; Hafner, Jürgen; Lebègue, Sébastien; Ángyán, János G

    2012-04-28

    Periodic dispersion corrected DFT calculations have been performed to study the spin-crossover transition of Fe(phen)(2)(NCS)(2) in the molecular and in the crystalline state. We show that London dispersion interactions play a crucial role in the cohesion of the crystals. Based on calculations of vibrational eigenstates of the isolated molecule and of the crystalline phase in both the low- and high-spin states, the transition entropies and enthalpies have been calculated. We demonstrate that, due to the stabilization of the low-spin state by intermolecular dispersion forces, the transition enthalpy at the transition temperature is larger for the crystalline phase in comparison with an isolated molecule. The effective coordination number of the nitrogen atoms of the ligands around the iron atom has been identified as the order parameter driving the quasi-reversible low-spin to high-spin transition in the crystal. Finally, using constrained geometry relaxations at fixed values of the coordination number, we computed the energy barrier of the LS to HS transition and found it to be in a reasonable agreement with the experimental value. PMID:22415338

  8. The pharmacokinetics and metabolism of ifosfamide during bolus and infusional administration: a randomized cross-over study.

    PubMed Central

    Singer, J. M.; Hartley, J. M.; Brennan, C.; Nicholson, P. W.; Souhami, R. L.

    1998-01-01

    In a randomized cross-over trial, 11 patients received ifosfamide (IFOS) in 21-day cycles, which alternated between 3 g m(-2) x (2 or 3) days given as a 1-h bolus doses, or the same total dose as a continuous infusion. Patients who received four or more cycles also alternated between two cycles on dexamethasone 4 mg 8 hourly for 3 days starting 8 h before IFOS, and two cycles off dexamethasone. A total of 34 patient cycles were studied and serum and urinary levels of IFOS, 2 dechloroethylifosfamide (2DC), 3 dechloroethylifosfamide (3DC), carboxyifosfamide (CX) and isophosphoramide mustard (IPM) were measured by thin-layer chromatography. No significant differences could be detected in the areas under the curve (AUCs) of serum concentration, nor in the proportion of IFOS or its metabolites found in the urine. There was no significant effect of dexamethasone on IFOS metabolism. These results indicate that there is no identifiable pharmacokinetic basis for insistence on either bolus or infusional methods of IFOS administration. PMID:9528844

  9. Exposure to air pollutants and mortality in hypertensive patients according to demography: a 10 year case-crossover study.

    PubMed

    Wong, Martin C S; Tam, Wilson W S; Wang, Harry H X; Lao, X Q; Zhang, Daisy Dexing; Chan, Sky W M; Kwan, Mandy W M; Fan, Carmen K M; Cheung, Clement S K; Tong, Ellen L H; Cheung, N T; Tse, L A; Yu, Ignatius T S

    2014-09-01

    This study evaluated whether short term exposures to NO2, O3, particulate matter <10 mm in diameter (PM10) were associated with higher risk of mortality. A total of 223,287 hypertensive patients attended public health-care services and newly prescribed at least 1 antihypertensive agent were followed-up for up to 5 years. A time-stratified, bi-directional case-crossover design was adopted. For all-cause mortality, significant positive associations were observed for NO2 and PM10 at lag 0-3 days per 10 μg/m(3) increase in concentration (excess risks 1.187%-2.501%). Significant positive associations were found for O3 at lag 1 and 2 days and the excess risks were 1.654% and 1.207%, respectively. We found similarly positive associations between these pollutants and respiratory disease mortality. These results were significant among those aged ≥65 years and in cold seasons only. Older hypertensive patients are susceptible to all-cause and respiratory disease-specific deaths from these air pollutants in cold weather. PMID:24953346

  10. 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

  11. 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

  12. 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.

  13. Adaptation of blood pressure to continuous heavy coffee drinking in young volunteers. A double-blind crossover study.

    PubMed Central

    Ammon, H P; Bieck, P R; Mandalaz, D; Verspohl, E J

    1983-01-01

    In a double-blind crossover trial, the effect of 4 week daily ingestion of eight cups of regular coffee (corresponding to 504 mg caffeine) vs eight cups of decaffeinated coffee was studied. Blood pressure, heart rate and urinary catecholamines were measured in eight healthy, young volunteers. In both groups, regular coffee immediately led to a significant increase in mean blood pressure (+ 3 and + 5 mm Hg respectively). The difference between both groups, however, existed only in the first 3 to 5 days of ingestion of regular coffee. On day 5 after ingestion of regular coffee, and thereafter in weekly intervals, no significant increase in catecholamine excretion was observed. The data suggest that long-term consumption of large amounts of coffee leads to only a small and transient rise in mean blood pressure. This may be due to an adaptation phenomenon. Therefore, continuous heavy coffee ingestion (eight cups/day for 4 weeks) by young persons does not appear to involve a risk of the development of hypertension. PMID:6871070

  14. 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

  15. 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.

  16. Randomized crossover trial of kangaroo care to reduce biobehavioral pain responses in preterm infants: a pilot study.

    PubMed

    Cong, Xiaomei; Ludington-Hoe, Susan M; Walsh, Stephen

    2011-04-01

    Kangaroo care (KC), skin-to-skin contact between mother and infant, is a promising method for blunting pain responses. This crossover pilot tested KC effects on biobehavioral responses to heel stick in preterm infants (30-32 weeks' gestational age, 2-9 days old) measured by Premature Infant Pain Profile (PIPP) and salivary and serum cortisol. Mother-infant dyads were randomly assigned to KC heel stick (KCH) first or incubator heel stick (IH) first. Study 1 (80-min study, N = 18) tested the effect of 80 min of KC before and throughout the heel stick procedure versus incubator care. Study 2 (30-min study, N = 10) tested 30 min of KC before and throughout the heel stick versus incubator care. KCH and IH began during a premeasurement phase and continued through four data collection phases: baseline, heel warming, heel stick, and recovery. PIPP responses were measured every 30 s during data collection; salivary cortisol was measured at the end of baseline and recovery; and serum cortisol was measured during heel stick. Study 1 showed no differences between KCH and IH. Study 2 showed lower PIPP scores at four time points during recovery (p < .05 to p < .001), lower salivary cortisol at the end of recovery (p < .05), and lower serum cortisol during heel stick for the KCH condition (p < .05) as well as clinically lower PIPP scores in the KCH condition during heel stick. Thirty minutes of KC before and throughout the heel stick reduced biobehavioral responses to pain in preterm infants. PMID:21196428

  17. Topical capsaicin—a novel and effective treatment for idiopathic intractable pruritus ani: a randomised, placebo controlled, crossover study

    PubMed Central

    Lysy, J; Sistiery-Ittah, M; Israelit, Y; Shmueli, A; Strauss-Liviatan, N; Mindrul, V; Keret, D; Goldin, E

    2003-01-01

    Purpose: Pruritus ani is a common and embarrassing proctological condition which can be very difficult to treat. We report the results of a double blind placebo controlled study of treatment with capsaicin. Methods: Firstly, a pilot open study was carried out on five patients to establish which of two doses was the most acceptable by comparing effectiveness and side effects. Secondly, a double blind, placebo controlled, crossover study of topical capsaicin was performed. This study involved two four week treatment phases separated by a one week washout phase. Forty four patients were randomised to receive locally either active capsaicin (0.006%) or placebo (menthol 1%) ointment over a four week period (22 patients per group). After four weeks of treatment and a one week washout period, the placebo group began to receive capsaicin while the treated group received placebo (menthol 1%) for another four weeks. At the end of the controlled study, responders from both groups continued with capsaicin treatment in an open labelled manner. Results: Thirty one of 44 patients experienced relief during capsaicin treatment periods and did not respond to menthol; all patients not responding to capsaicin also failed on menthol (p<0.0001). In 13 patients, treatment with capsaicin was unsuccessful: eight patients did not respond to capsaicin treatment, one responded equally to capsaicin and placebo, and four others dropped out because of side effects. During the follow up period (mean 10.9 (SD 5.8) months), 29 “responders” needed a mean application of capsaicin every day (1.6 (SD 1.2); range 0.5–7 days) to remain symptom free (or nearly symptom free). Conclusion: Capsaicin is a new, safe, and highly effective treatment for severe intractable idiopathic pruritus ani. PMID:12912865

  18. Pharmacokinetic interaction between udenafil and dapoxetine: a randomized, open-labeled crossover study in healthy male volunteers

    PubMed Central

    Kim, Yo Han; Choi, Hee Youn; Lee, Shi Hyang; Jeon, Hae Sun; Lim, Hyeong-Seok; Bahng, Mi Young; Bae, Kyun-Seop

    2015-01-01

    Background “Udenafil” is a phosphodiesterase-5 inhibitor indicated for erectile dysfunction. “Dapoxetine” is a serotonin transport inhibitor indicated for premature ejaculation. The aim of the study reported here was to investigate the pharmacokinetic drug interaction between udenafil and dapoxetine in healthy male subjects. Methods An open-label, three-treatment, six-sequence, three-period crossover study was performed in healthy male subjects. In varying sequences, each subjects received single oral doses of udenafil 200 mg, dapoxetine 60 mg, and both treatments. The periods were separated by a washout period of 7 days. Serial blood samples were collected up to 48 hours after dosing. The plasma concentrations of udenafil and dapoxetine were determined using a validated liquid chromatography-tandem mass spectrometry method. Pharmacokinetic parameters were obtained by non-compartmental analysis. Tolerability was assessed throughout the study. Results Twenty-three healthy subjects completed the study. The geometric mean ratios of the area under the plasma concentration–time curve from time 0 to last measurable time point and measured peak plasma concentration for udenafil were 0.923 (90% confidence interval [CI]: 0.863–0.987) and 0.864 (90% CI: 0.789–0.947), respectively. The geometric mean ratios of the area under the plasma concentration–time curve from time 0 to last measurable time point and measured peak plasma concentration for dapoxetine were 1.125 (90% CI: 1.044–1.213) and 0.837 (90% CI: 0.758–0.925), respectively. There were no serious adverse events reported, and none of the subjects dropped out due to adverse events. Conclusion Udenafil was found to have no clinically significant pharmacokinetic interactions with dapoxetine. The concurrent administration of udenafil and dapoxetine was generally well tolerated. PMID:25759565

  19. Beneficial effect of tagatose consumption on postprandial hyperglycemia in Koreans: a double-blind crossover designed study.

    PubMed

    Kwak, Jung Hyun; Kim, Min Sun; Lee, Jin Hee; Yang, Yoon Jung; Lee, Ki Ho; Kim, Oh Yoen; Lee, Jong Ho

    2013-08-01

    The present study determined the effect of tagatose supplementation on postprandial hyperglycemia in normal (n = 54) and hyperglycemic subjects [n = 40, impaired fasting glucose (IFG) and newly diagnosed type 2 diabetes]. In a double-blind crossover designed study, study subjects were randomly assigned to consume a sucralose-erythritol drink (the placebo) or a tagatose-containing drink (the test) with a seven-day interval. Finally, 85 subjects completed the study (normal, n = 52; hyperglycemic, n = 33). Blood samples were collected at 0, 30, 60 and 120 min after ingestion and analyzed for fasting and postprandial levels of glucose, insulin and C-peptide. Basic anthropometric parameters and lipid files were also measured. Hyperglycemic subjects were basically older and heavier, and showed higher levels of triglyceride, total- and LDL-cholesterols and apolipoprotein AI and B compared with normal subjects. After consuming the tagatose (5 g)-containing drink, hyperglycemic subjects had a significant reduction in serum levels of glucose at 120 min (p = 0.019) and glucose area under the curve (AUC) (p = 0.017), however these were not observed in normal subjects. When ages were matched between the two groups, the glucose response patterns were shown to be similar. Additionally, normal subjects who received a high-dose of tagatose-containing drinks (10 g) showed significantly lower levels of insulin at 30 min (p = 0.004) and 60 min (p = 0.011), insulin AUC (p = 0.009), and C-peptide at 30 min (p = 0.004), 60 min (p = 0.011) and C-peptide AUC (p = 0.023). In conclusion, a single dietary supplement in the form of a tagatose-containing drink may be beneficial for controlling postprandial glycemic response in Koreans. PMID:23760573

  20. Efficacy of a novel chitosan formulation on fecal fat excretion: a double-blind, crossover, placebo-controlled study.

    PubMed

    Barroso Aranda, Jorge; Contreras, Francisco; Bagchi, Debasis; Preuss, Harry G

    2002-01-01

    The ability of a novel chitosan formulation to influence gastrointestinal fat absorption in vivo was examined in a double-blind, placebo-controlled, crossover study by determining the content of total fat in feces in two groups of subjects. Twenty-nine normal healthy subjects were recruited for the study. Twenty-four participants completed the test period with the chitosan formulation, and 21 completed the placebo phase of study. During the placebo and the test periods, the subjects were administered six capsules three times daily 10 minutes before meals for three days and for the two days of the stool collection. A daily serving of six tablets of the test compound contained 2100 mg chitosan and 300 mg psyllium husk seeds. In respect to the baseline period, the test compound increased fat excretion significantly whether the test period preceded or proceeded the placebo period (p<0.02 and p<0.05 respectively). In contrast, essentially no changes were seen during the placebo loading periods. Compared to the difference between placebo period and its baseline period, a statistically significant increase in fecal fat excretion was observed over baseline following oral supplementation of a novel formulation of chitosan and psyllium husk seeds [+3.63 gm/day +/- 0.83 (SEM) vs. -0.15 gm/day +/- 0.94 (SEM) (p=0.004)]. The average daily increase in fecal fat of 3-4 grams over control could account for a decrease in calorie consumption of 30-40 kcal per day. A total of 19 subjects completed both parts of the study. Examining the data from these 19 subjects by ANOVA, it was found that the period when the test compounds were given was statistically significantly different from the placebo baseline, placebo experimental, and test baseline periods. Using multiple comparisons, it was ascertained that the novel formulation containing chitosan plus psyllium husk seeds increases fecal fat excretion. PMID:12939120

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

    PubMed Central

    2012-01-01

    Background In the past decade, the proportion snacking has increased. Snack foods consumed are predominantly not nutritious foods. One potential venue to increase children’s diet quality is to offer healthy snack foods and we explored if shaped snack foods would lead to increased consumption. Methods We investigated the consumption of high-fiber snacks (banana bread, pancakes, and sandwiches) served either in normal (round, square) or shaped (heart, hands, animals) form to preschoolers 2–5 years old attending a local child care center (n = 21). The 9 weeks long, prospective, cross-over intervention study was designed to expose each child repeatedly to each snack in each shape (4 times per snack). Snacks were served as morning or afternoon snack and caretakers’ reports were used to account for the child’s consumption of a meal preceding the study snack (breakfast or lunch). Results There was no significant difference in snack consumption between the shaped and normal snacks. However, the mean energy intake from snacks was significantly greater for Caucasian children compared with Asian children. Further, Asian children consumed much less banana bread than the other two snacks. Overall, children who had not eaten breakfast or lunch prior to the morning or afternoon snack ate significantly more calories from the snacks (84.1 kcal, p-value < 0.0001). Conclusion Findings of this study confirm previous research that the shape of the foods does not affect snack consumption in children. However, we also report two unexpected findings: a) the strong interaction between ethnicity and snack consumption and b) that Asian children consumed much less banana bread than Caucasian children. The role of children’s ethnic background profoundly affects snack preference and must be considered in the study of children’s eating behaviors and in interventions to promote healthy eating habits. PMID:22866912

  2. Sample size calculations for crossover thorough QT studies: satisfaction of regulatory threshold and assay sensitivity.

    PubMed

    Anand, Suraj P; Murray, Sharon C; Koch, Gary G

    2010-05-01

    The cost for conducting a "thorough QT/QTc study" is substantial and an unsuccessful outcome of the study can be detrimental to the safety profile of the drug, so sample size calculations play a very important role in ensuring adequate power for a thorough QT study. Current literature offers some help in designing such studies, but these methods have limitations and mostly apply only in the context of linear mixed models with compound symmetry covariance structure. It is not evident that such models can satisfactorily be employed to represent all kinds of QTc data, and the existing literature inadequately addresses whether there is a change in sample size and power for more general covariance structures for the linear mixed models. We assess the use of some of the existing methods to design a thorough QT study through data arising from a GlaxoSmithKline (GSK)-conducted thorough QT study, and explore newer models for sample size calculation. We also provide a new method to calculate the sample size required to detect assay sensitivity with adequate power. PMID:20358438

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

    PubMed Central

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

    2014-01-01

    Background Smartphone-based assessment may be a useful diagnostic and monitoring tool for patients. There have been many attempts to create a smartphone diagnostic tool for clinical use in various medical fields but few have demonstrated scientific validity. Objective The purpose of this study was to develop a smartphone application of the International Prostate Symptom Score (IPSS) and to demonstrate its validity and reliability. Methods From June 2012 to May 2013, a total of 1581 male participants (≥40 years old), with or without lower urinary tract symptoms (LUTS), visited our urology clinic via the health improvement center at Soonchunhyang University Hospital (Republic of Korea) and were enrolled in this study. A randomized repeated measures crossover design was employed using a smartphone application of the IPSS and the conventional paper form of the IPSS. Paired t test under a hypothesis of non-inferior trial was conducted. For the reliability test, the intraclass correlation coefficient (ICC) was measured. Results The total score of the IPSS (P=.289) and each item of the IPSS (P=.157-1.000) showed no differences between the paper version and the smartphone version of the IPSS. The mild, moderate, and severe LUTS groups showed no differences between the two versions of the IPSS. A significant correlation was noted in the total group (ICC=.935, P<.001). The mild, moderate, and severe LUTS groups also showed significant correlations (ICC=.616, .549, and .548 respectively, all P<.001).There was selection bias in this study, as only participants who had smartphones could participate. Conclusions The validity and reliability of the smartphone application version were comparable to the conventional paper version of the IPSS. The smartphone application of the IPSS could be an effective method for measuring lower urinary tract symptoms. PMID:24513507

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Modulation of Protein Fermentation Does Not Affect Fecal Water Toxicity: A Randomized Cross-Over Study in Healthy Subjects

    PubMed Central

    Windey, Karen; De Preter, Vicky; Louat, Thierry; Schuit, Frans; Herman, Jean; Vansant, Greet; Verbeke, Kristin

    2012-01-01

    Objective Protein fermentation results in production of metabolites such as ammonia, amines and indolic, phenolic and sulfur-containing compounds. In vitro studies suggest that these metabolites might be toxic. However, human and animal studies do not consistently support these findings. We modified protein fermentation in healthy subjects to assess the effects on colonic metabolism and parameters of gut health, and to identify metabolites associated with toxicity. Design After a 2-week run-in period with normal protein intake (NP), 20 healthy subjects followed an isocaloric high protein (HP) and low protein (LP) diet for 2 weeks in a cross-over design. Protein fermentation was estimated from urinary p-cresol excretion. Fecal metabolite profiles were analyzed using GC-MS and compared using cluster analysis. DGGE was used to analyze microbiota composition. Fecal water genotoxicity and cytotoxicity were determined using the Comet assay and the WST-1-assay, respectively, and were related to the metabolite profiles. Results Dietary protein intake was significantly higher during the HP diet compared to the NP and LP diet. Urinary p-cresol excretion correlated positively with protein intake. Fecal water cytotoxicity correlated negatively with protein fermentation, while fecal water genotoxicity was not correlated with protein fermentation. Heptanal, 3-methyl-2-butanone, dimethyl disulfide and 2-propenyl ester of acetic acid are associated with genotoxicity and indole, 1-octanol, heptanal, 2,4-dithiapentane, allyl-isothiocyanate, 1-methyl-4-(1-methylethenyl)-benzene, propionic acid, octanoic acid, nonanoic acid and decanoic acid with cytotoxicity. Conclusion This study does not support a role of protein fermentation in gut toxicity. The identified metabolites can provide new insight into colonic health. Trial Registration ClinicalTrial.gov NCT01280513 PMID:23285019

  11. 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

  12. Comparison of 7 α(1)-adrenoceptor antagonists in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia:a short-term crossover study.

    PubMed

    Araki, Tohru; Monden, Koichi; Araki, Motoo

    2013-01-01

    A crossover study was conducted to identify the best α1-adrenoceptor (α1AR) antagonist for individual patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). One hundred thirteen patients (mean age 70.8 years) were enrolled. All patients met BPH clinical study guidelines. Seven agents were utilized:tamsulosin 0.2mg, silodosin 8mg, urapidil 60mg, naftopidil 50mg, prazosin 1mg, terazosin 2mg, and doxazosin 1mg. Patients were initially prescribed tamsulosin or silodosin for a week and then urapidil for a week. Two weeks later, they were prescribed the better of the 2 agents for a week and a new agent for the next week. This cycle was repeated until all 7 agents were tested. Efficacy was evaluated with the International Prostate Symptom Score. The agent rankings were doxazosin (25 [22%]), silodosin (22 [19%]), urapidil (19 [17%]), naftopidil (17 [15%]), terazosin (12 [11%]), tamsulosin (11 [10%]), prazosin (7 [6%]). Only 12 patients (11%) changed agents after the crossover study was completed. The major reason was adverse events (83%). We found that each of the 7 α1AR antagonists has its own supporters. Further, the one-week crossover study was useful in identifying the best agent for the treatment of each individual with LUTS. PMID:23970323

  13. Comparison of the efficacy of olopatadine and fexofenadine in chronic idiopathic urticaria patients: a crossover study.

    PubMed

    Tanizaki, Hideaki; Yamamoto, Yosuke; Nakamizo, Satoshi; Otsuka, Atsushi; Miyachi, Yoshiki; Kabashima, Kenji

    2015-01-01

    Olopatadine is one of the second-generation H1 antihistamines that were used for treating allergic disorders initially in Asia, and now also in Western countries. Whereas several trials compared the efficacy on chronic urticaria among second-generation H1 antihistamines, no study has directly compared the clinical efficacy between olopatadine and other H1 antihistamines in patients with chronic idiopathic urticaria (CIU). In this study, we address this issue for the first time and conclude that olopatadine is a good candidate for the treatment of CIU. PMID:25592003

  14. 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…

  15. 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...

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  1. 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

  2. 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

  3. 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

  4. 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. PMID:26011042

  5. Traditional and pyramidal resistance training systems improve muscle quality and metabolic biomarkers in older women: A randomized crossover study.

    PubMed

    Ribeiro, Alex S; Schoenfeld, Brad J; Souza, Mariana F; Tomeleri, Crisieli M; Venturini, Danielle; Barbosa, Décio S; Cyrino, Edilson S

    2016-06-15

    The purpose of this study was to compare the effect of RT performed in a pyramid (PR) and traditional (TD) straight set training system on muscle quality and metabolic biomarkers in older women. Twenty-five physically independent older women (67.6±5.1years, 65.9±11.1kg, 154.7±5.8cm) performed a RT program in TD and PR training systems in a balanced crossover design. Measurements of muscle quality, serum levels of C-reactive protein (CRP), glucose (GLU), total cholesterol, high-density lipoprotein (HDL-C), low-density lipoprotein (LDL-C), and triglycerides (TG) were obtained at different moments. The TD program consisted of 3 sets of 8-12 repetitions maximum (RM) with a constant weight for the 3 sets, whereas the PR training consisted of 3 sets of 12/10/8 RM with incremental weight for each set. The training was performed in 2 phases of 8weeks each, with a 12-week washout period between phases. Significant (P<0.05) improvements were observed in both groups for muscle quality (TD=+8.6% vs. PR=+6.8%), GLU (TD=-4.5% vs. PR=-1.9%), TG (TD=-18.0% vs. PR=-11.7%), HDL-C (TD=+10.6 vs. PR=+7.8%), LDL-C (TD=-23.3% vs. PR=-21.0%), and CRP (TD=-19.4% vs. PR=-14.3%) with no differences between training systems. These results suggest that RT improves muscle quality and metabolic biomarkers of older women independently of the training system. PMID:26972635

  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. PMID:25609231

  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. Assessment of the Abuse Potential of the Orexin Receptor Antagonist, Suvorexant, Compared With Zolpidem in a Randomized Crossover Study.

    PubMed

    Schoedel, Kerri A; Sun, Hong; Sellers, Edward M; Faulknor, Janice; Levy-Cooperman, Naama; Li, Xiaodong; Kennedy, William P; Cha, Jang-Ho; Lewis, Nicole M; Liu, Wen; Bondiskey, Phung; McCrea, Jacqueline B; Panebianco, Deborah L; Troyer, Matthew D; Wagner, John A

    2016-08-01

    Suvorexant is a dual orexin receptor antagonist approved in the United States and Japan for the treatment of insomnia at a maximum dose of 20 mg. This randomized double-blind crossover study evaluated the abuse potential of suvorexant in 36 healthy recreational polydrug users with a history of sedative and psychedelic drug use. Single doses of suvorexant (40, 80, and 150 mg: 2-7.5 × maximum dose), zolpidem (15 and 30 mg: 1.5-3 × maximum dose), and placebo were administered, with a 10-day washout between treatments. Subjective and objective measures, including visual analog scales (VASs), Addiction Research Center Inventory, and cognitive/psychomotor tests, were evaluated for 24-hour postdose. Suvorexant had significantly greater peak effects on "drug liking" VAS (primary endpoint) than placebo. Although effects of suvorexant on abuse potential measures were generally similar to zolpidem, they remained constant across doses, whereas zolpidem often had greater effects at higher doses. Suvorexant (all doses) had significantly fewer effects than zolpidem 30 mg on secondary measures, such as "high" VAS, Bowdle VAS, and Addiction Research Center Inventory morphine-benzedrine group. The overall incidence of abuse-related adverse events, such as euphoric mood and hallucination, was numerically lower with suvorexant than zolpidem. In agreement with its classification as a schedule IV drug, suvorexant demonstrated abuse potential, compared with placebo. The abuse potential was similar to zolpidem using certain measures, but with a reduced incidence of abuse-related adverse events. Although this suggests that the overall abuse liability of suvorexant may be lower than zolpidem, the actual abuse rates will be assessed with the postmarketing experience. PMID:27253658

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

    PubMed Central

    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. PMID:26167938

  10. Randomized, Placebo-Controlled, Crossover Study of Methylphenidate for Attention-Deficit/Hyperactivity Disorder Symptoms in Preschoolers with Developmental Disorders

    PubMed Central

    Aman, Michael G.; Lecavalier, Luc; Riddle, Mark A.; Gelenberg, Alan; Wright, Ron; Rice, Sydney; Ghuman, Harinder S.; Fort, Carolyn

    2009-01-01

    Abstract Objective The aim of this study was to investigate the short-term efficacy and safety of methylphenidate (MPH) to treat attention-deficit/hyperactivity disorder (ADHD) symptoms in an understudied population of preschoolers with pervasive developmental disorder (PDD) or intellectual disability (ID). Methods Fourteen preschoolers with developmental disorders (DD, n = 14; PDD, n = 12; ID, n = 2) underwent MPH titration in a single-blind manner followed by a 4-week double-blind crossover phase. Each child was administered placebo for 2 weeks and “optimal dose” for 2 weeks. The primary outcome measure was the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) ADHD subscale of the Conners' Parent Rating Scale-Revised (CPRS-R-DSM-IV-ADHD). Results MPH improved parent-rated ADHD symptoms of the preschoolers; 50% were rated as responders. The CPRS-R-DSM-IV-ADHD subscale was significant for the PDD subgroup (p = 0.005, Cohen d = 0.97) and marginally significant for the entire DD sample (p = 0.08, Cohen d = 0.50). Half of the preschoolers experienced side effects with MPH, including reports of increased stereotypic behavior, upset stomach, sleep-related difficulties, and emotional lability. One child discontinued during titration due to side effects. Conclusion The predominant direction of response in these preschoolers with both ADHD and PDD/ID favored MPH, even though the response was more subtle and variable than in older and typically developing children. Due to high rates of adverse effects, preschoolers should be monitored closely. PMID:19702485

  11. Medication use as a risk factor for inpatient falls in an acute care hospital: a case-crossover study

    PubMed Central

    Shuto, Hideki; Imakyure, Osamu; Matsumoto, Junichi; Egawa, Takashi; Jiang, Ying; Hirakawa, Masaaki; Kataoka, Yasufumi; Yanagawa, Takashi

    2010-01-01

    AIMS The present study aimed to evaluate the associations between medication use and falls and to identify high risk medications that acted as a trigger for the onset of falls in an acute care hospital setting. METHODS We applied a case-crossover design wherein cases served as their own controls and comparisons were made within each participant. The 3-day period (days 0 to −2) and the 3-day periods (days −6 to −8, days −9 to −11 and days −12 to −14) before the fall event were defined as the case period and the control periods, respectively. Exposures to medications were compared between the case and control periods. Odds ratios (OR) and 95% confidence intervals (CI) for the onset of falls with respect to medication use were computed using conditional logistic regression analyses. RESULTS A total of 349 inpatients who fell during their hospitalization were recorded on incident report forms between March 2003 and August 2005. The initial use of antihypertensive, antiparkinsonian, anti-anxiety and hypnotic agents as medication classes was significantly associated with an increased risk of falls, and these ORs (95% CI) were 8.42 (3.12, 22.72), 4.18 (1.75, 10.02), 3.25 (1.62, 6.50) and 2.44 (1.32, 4.51), respectively. The initial use of candesartan, etizolam, biperiden and zopiclone was also identified as a potential risk factor for falls. CONCLUSIONS Medical professionals should be aware of the possibility that starting a new medication such as an antihypertensive agent, including candesartan, and antiparkinsonian, anti-anxiety and hypnotic agents, may act as a trigger for the onset of a fall. PMID:20573090

  12. 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

  13. Combined effects of aerobic exercise and l-arginine ingestion on blood pressure in normotensive postmenopausal women: A crossover study.

    PubMed

    Puga, Guilherme M; de P Novais, Iane; Katsanos, Christos S; Zanesco, Angelina

    2016-04-15

    After menopause the incidence of cardiovascular diseases increases in women. A decrease in nitric oxide (NO) bioavailability has been pointed out to play a major role in this phenomenon. Since it is believed that l-arginine administration could improve NO bioavailability, the aim of this study was to examine the effects of acute l-arginine administration associated with aerobic exercise on blood pressure (BP), redox state and inflammatory biomarkers in normotensive postmenopausal women (NPW). Sixteen volunteers (57±6yr) were subjected to four experimental sessions (crossover design): arginine+exercise (A-E); arginine (ARG); exercise+placebo (EXE); control (CON). Each session was initiated with either 9g of l-arginine ingestion (ARG or A-E days), placebo (EXE day), or nothing (CON day). The participants performed 30min of aerobic exercise (A-E and EXE days) or sitting rest (CON and ARG days). Blood samples were collected before each session and 45min after the intervention. Office BP and ambulatory blood pressure monitoring (ABPM) were evaluated. NO/cGMP pathway, redox state and inflammatory biomarkers were measured. Systolic BP decreased during the 24-hour in A-E and EXE sessions. However, diastolic BP reduced only in A-E session. No changes were found in the biomarkers concentrations. In conclusion, the association was effective in lowering diastolic BP in NPW. Additionally, physical exercise alone promoted a long lasting effect on systolic BP measured by ABPM in this population, although this beneficial effect was not associated with changes in the cardio-inflammatory biomarkers. Possibly, other factors such as neural influences could be mediating this effect. PMID:26972606

  14. A Randomized, Crossover Study to Evaluate the Pharmacokinetics of Amantadine and Oseltamivir Administered Alone and in Combination

    PubMed Central

    Morrison, Dennis; Roy, Sandip; Rayner, Craig; Amer, Ahmed; Howard, Dan; Smith, James R.; Evans, Thomas G.

    2007-01-01

    The threat of potential pandemic influenza requires a reevaluation of licensed therapies for the prophylaxis or treatment of avian H5N1 infection that may adapt to man. Among the therapies considered for use in pandemic influenza is the co-administration of ion channel and neuraminidase inhibitors, both to potentially increase efficacy as well as to decrease the emergence of resistant isolates. To better understand the potential for drug interactions, a cross-over, randomized, open-label trial was conducted with amantadine, 100 mg po bid, and oseltamivir, 75 mg po bid, given alone or in combination for 5 days. Each subject (N = 17) served as their own control and was administered each drug alone or in combination, with appropriate wash-out. Co-administration with oseltamivir had no clinically significant effect on the pharmacokinetics (PK) of amantadine [mean ratios (90% CI) for AUC0-12 0.93 (0.89, 0.98) and Cmax 0.96 (0.90, 1.02)]. Similarly, amantadine co-administration did not affect oseltamivir PK [AUC0-12 0.92 (0.86, 0.99) and Cmax 0.85 (0.73, 0.99)] or the PK of the metabolite, oseltamivir carboxylate [AUC0-12 0.98 (0.95, 1.02) and Cmax 0.95 (0.89, 1.01)]. In this small trial there was no evidence of an increase in adverse events. Although many more subjects would need to be studied to rule out a synergistic increase in adverse events, the combination in this small human drug-drug interaction trial appears safe and without pharmacokinetic consequences. Trial Registration ClinicalTrials.gov NCT00416962 PMID:18074029

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

    PubMed Central

    2013-01-01

    Background Aim was to compare clinical findings with x-ray findings using dental panoramic radiography (DPR). In addition, type and frequency of secondary findings in x-rays were investigated. Methods Patients were selected on the basis of available DPRs (not older than 12 months). No therapeutic measures were permitted between the DPR and the clinical findings. The clinical findings were carried out by several investigators who had no knowledge of the purpose of the study. A calibrated investigator established the x-ray findings, independently and without prior knowledge of the clinical findings. The evaluation parameters for each tooth were: missing, healthy, carious, restorative or prosthetically sufficient or insufficient treatment. Type and frequency of additional findings in the DPR were documented, e.g. quality of a root canal filling and apical changes. Results Findings of 275 patients were available. Comparison showed a correspondence between clinical and radiographic finding in 93.6% of all teeth (n = 7,789). The differences were not significant (p > 0.05). Regarding carious as well as insufficiently restored or prosthetically treated teeth, respectively there were significant differences between the two methods (p < 0.05). The DPRs showed additional findings: root fillings in 259 teeth and 145 teeth with periapical changes. Conclusions With reference to the assessment of teeth, there was no difference between the two methods. However, in the evaluation of carious as well as teeth with insufficiently restorative or prosthetic treatment, there was a clear discrepancy between the two methods. Therefore, it would have been possible to have dispensed with x-rays. Nevertheless, additional x-ray findings were found. PMID:24066660

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

    PubMed Central

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

    2014-01-01

    Background: Premature infants not only feel and understand the pain, but also respond more intensively compared with term infants. Non-pharmacological methods of pain control are suitable to relieve pain in painful procedures. The facilitated tucking position is considered as a non-pharmacological method of pain control in infants; however, its impact on frequent and repeated procedural pain such as endotracheal suctioning remains to be studied. Objectives: This paper is the report of a study that examined the impact of facilitated tucking position on behavioral pain during suctioning in premature neonates. Design: This was a clinical trial study with a crossover design. Settings: The study was conducted in a level II Neonatal Intensive Care Unit, located in a teaching hospital, affiliated to Tehran University of Medical Sciences, Tehran, Iran. Participants: Thirty four infants were enrolled in this study based on the following inclusion criteria: age between 29 to 37 weeks of gestational age, birth weight 1200 grams or more, having an endotracheal tube, no congenital anomalies, no seizures diagnosis, no chest tubes, no intracranial hemorrhage higher than degree II, not receiving opiates and sedatives four hours before intervention and not receiving any painful procedure at least half an hour before the intervention. Methods: The samples were randomly received a sequence of suctioning with/without or suctioning without/with facilitated tucking. Preterm Infant Pain Profile (PIPP) was used to collect the data. SPSS version 16.0 for Windows (SPSS Inc., Chicago, IL, USA) was used for statistical analysis. Results: While 38.2% of infants experienced severe pain during suctioning without intervention, only 8.8% of them experienced severe pain during suctioning with intervention. The results of the paired t-test show that there is a statistically significant difference in the mean scores of pain between non-intervention and intervention cases (p<0.001), and the mean pain

  17. 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

  18. An open-label, randomized, cross-over bioequivalence study of lafutidine 10 mg under fasting condition

    PubMed Central

    Dewan, Bhupesh; Chimata, Raghuram

    2010-01-01

    AIM: To assess the relative bioavailability and pharmacokinetic properties of two formulations (test and reference) of Lafutidine 10 mg. METHODS: The study was performed as an open label, randomized, two-way, two-period, two-treatment, single dose cross-over bioequivalence study, under non-fed condition to compare the pharmacokinetic profiles of the lafutidine formulation manufactured by Emcure Pharmaceuticals Ltd., India using an indigenously developed active pharmaceutical ingredient (API) and the commercially available Stogra® formulation, of UCB Japan Co., Ltd., Japan. The two treatments were separated by a wash-out period of 5 d. After an overnight fasting period of 10 h, the subjects were administered either the test or the reference medication as per the randomization schedule. Blood samples were collected at intervals up to 24 h, as per the approved protocol. Concentrations of lafutidine in plasma were analyzed by a validated liquid chromatography/tandem mass spectrometry (LC/MS/MS) method, and a non-compartmental model was used for pharmacokinetic analysis. The pharmacokinetic parameters were subjected to a 4-way ANOVA accounting for sequence, subjects, period and treatment. Statistical significance was evaluated at 95% confidence level (P ≥ 0.05). RESULTS: The mean (± SD) values of the pharmacokinetic parameters (test vs reference) were Cmax (265.15 ± 49.84 ng/mL vs 246.79 ± 29.30 ng/mL, P < 0.05), Area under the curve (AUC)(0-t) (1033.13 ± 298.74 ng.h/mL vs 952.93 ± 244.07 ng.h/mL, P < 0.05), AUC(0-∞) (1047.61 ± 301.22 ng.h/mL vs 964.21 ± 246.45 ng.h/mL, P < 0.05), and t½(1.92 ± 0.94 h vs 2.05 ± 1.01 h, P < 0.05). The 90% confidence intervals (CI) for the test/reference ratio of mean Cmax, AUC(0-t), and AUC(0-∞) were within the acceptable range of 80.00 to 125.00. The mean times (± SD) to attain maximal plasma concentration (tmax) of lafutidine were 0.95 ± 0.24 h vs 1.01 ± 0.29 h (P < 0.05) for the test and the reference formulations

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

    PubMed

    Bro, S; Rasmussen, R A; Handberg, J; Olgaard, K; Feldt-Rasmussen, B

    1998-02-01

    The objective of the study was to evaluate the phosphate-binding efficacy, side effects, and cost of therapy of calcium ketoglutarate granulate as compared with calcium carbonate tablets in patients on chronic hemodialysis. The study design used was a randomized, crossover open trial, and the main outcome measurements were plasma ionized calcium levels, plasma phosphate levels, plasma intact parathyroid hormone (PTH) levels, requirements for supplemental aluminum-aminoacetate therapy, patient tolerance, and cost of therapy. Nineteen patients on chronic hemodialysis were treated with a dialysate calcium concentration of 1.25 mmol/L and a fixed alfacalcidol dose for at least 2 months. All had previously tolerated therapy with calcium carbonate. Of the 19 patients included, 10 completed both treatment arms. After 12 weeks of therapy, the mean (+/-SEM) plasma ionized calcium level was significantly lower in the ketoglutarate arm compared with the calcium carbonate arm (4.8+/-0.1 mg/dL v 5.2+/-0.1 mg/dL; P = 0.004), whereas the mean plasma phosphate (4.5+/-0.3 mg/dL v 5.1+/-0.1 mg/dL) and PTH levels (266+/-125 pg/mL v 301+/-148 pg/mL) did not differ significantly between the two treatment arms. Supplemental aluminum-aminoacetate was not required during calcium ketoglutarate treatment, while two patients needed this supplement when treated with calcium carbonate. Five of 17 (29%) patients were withdrawn from calcium ketoglutarate therapy within 1 to 2 weeks due to intolerance (anorexia, vomiting, diarrhea, general uneasiness), whereas the remaining 12 patients did not experience any side effects at all. The five patients with calcium ketoglutarate intolerance all had pre-existing gastrointestinal symptoms; four of them had received treatment with cimetidine or omeprazol before inclusion into the study. Calculations based on median doses after 12 weeks showed that the cost of the therapy in Denmark was 10 times higher for calcium ketoglutarate compared with calcium

  20. The pharmacodynamic equivalence of levothyroxine and liothyronine. A randomized, double blind, cross-over study in thyroidectomized patients

    PubMed Central

    Celi, Francesco S.; Zemskova, Marina; Linderman, Joyce D.; Babar, Nabeel I.; Skarulis, Monica C.; Csako, Gyorgy; Wesley, Robert; Costello, Rene; Penzak, Scott R.; Pucino, Frank

    2009-01-01

    Summary Context The substitution of liothyronine (l-T3) for levothyroxine (l-T4) is commonly employed during thyroid hormone (TH) withdrawal in preparation for diagnostic and therapeutic interventions on thyroid cancer patients. Presently, only limited data are available on the l-T3 for l-T4 therapeutic substitution. Objective To characterize the pharmcodynamic equivalence of l-T3 and l-T4. Design Randomized, double-blind, cross-over intervention study. Setting NIH Clinical Center. Patients 10 thyroidectomized patients. Interventions Study participants were treated with l-T3 or l-T4 with a target TSH ≥0.5≤1.5 mU/l for at least 30 days before undergoing inpatient testing. Following testing, subjects crossed-over according to the same scheme. Main outcome measures Area under the serum concentration-time curve of TSH from 0 to 60 minutes (AUC 0-60) and peak TSH serum concentration (Cmax) following thyrotropin-releasing hormone (TRH) stimulation test, total l-T4 and l-T3 dose (mcg/kg), and l-T4/l-T3 ratio. Results No difference was observed for time 0 TSH values between l-T3 and l-T4 replacement phases (1.48± 0.77 vs. 1.21± 0.62 mU/l, p=0.293) at average daily doses of 40.3±11.3 mcg lT-3 and 115.2±38.5 mcg lT-4, l-T3: l-T4 ratio 0.36±0.06. TRH stimulation test resulted in similar l-T3 vs.l-T4 TSH responses with AUC 0-60 of 326.1 (95% CI 232.6-457.1) and 247.1 (95% CI 153.8-397.1) mU*min /l (p=0.285); and Cmax of 6.83 (95% CI 4.88-9.55) and 5.23 (95% CI 3.31-8.3) mU/l (p=0.383). Conclusions This is the first study addressing the equivalency between l-T3 and l-T4 therapy measured by baseline and TRH-stimulated TSH. The therapeutic substitution of l-T3 for l-T4 was achieved at approximately 1:3 ratio. PMID:20447070

  1. A single-dose, two-way crossover, bioequivalence study of dexmethylphenidate HCl with and without food in healthy subjects.

    PubMed

    Teo, Steve K; Scheffler, Michael R; Wu, Anfan; Stirling, David I; Thomas, Steve D; Stypinski, Daria; Khetani, Vikram D

    2004-02-01

    Attention deficit hyperactivity disorder (ADHD) in children is effectively treated by racemic oral methylphenidate (dl-MPH). The d-isomer (d-MPH) has been developed as an improved treatment for ADHD since only half the racemic dose is used. This study, performed in healthy subjects, assessed the effect of food on the pharmacokinetics of dexmethylphenidate hydrochloride (d-MPH HCl) in a single dose (2 x 10-mg tablets), two-way crossover with d-MPH administered to subjects in both a fasting state or after a high-fat breakfast. There were no serious or unexpected adverse events during the course of this study, with most events reported in comparable numbers of fed and fasted subjects. The bioequivalence of d-MPH was similar with or without food, with 90% confidence intervals of 88.2% to 104.6% and 105.9% to 118.2% for ln(C(max)) and ln[(AUC(0-infinity))], respectively. There was a marginal but statistically significant 1-hour increase in t(max) in the fed versus fasted state, reflecting an absorption delay. The rate of formation of the major metabolite, d-ritalinic acid (d-RA), was marginally decreased ( approximately 14%) after food. The extent of exposure to d-RA was similar (within 1.2%) between both treatments. There was a marginal but statistically significant difference in mean t(max) for d-RA between fed and fasted conditions, with peak concentration occurring 1.5 hours later after d-MPH administration with food. There was no measurable in vivo chiral inversion of d-MPH to l-MPH in plasma. In addition, the metabolism of d-MPH was stereospecific as d-MPH only produced d-RA. In summary, food had no substantial effect on the bioavailability of d-MPH, with an equivalent rate and extent of exposure obtained. Therefore, d-MPH can be administered without regard to food intake. PMID:14747426

  2. 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

  3. Does a reduced glucose intake prevent hyperglycemia in children early after cardiac surgery? a randomized controlled crossover study

    PubMed Central

    2012-01-01

    Introduction Hyperglycemia in children after cardiac surgery can be treated with intensive insulin therapy, but hypoglycemia is a potential serious side effect. The aim of this study was to investigate the effects of reducing glucose intake below standard intakes to prevent hyperglycemia, on blood glucose concentrations, glucose kinetics and protein catabolism in children after cardiac surgery with cardiopulmonary bypass (CPB). Methods Subjects received a 4-hour low glucose (LG; 2.5 mg/kg per minute) and a 4-hour standard glucose (SG; 5.0 mg/kg per minute) infusion in a randomized blinded crossover setting. Simultaneously, an 8-hour stable isotope tracer protocol was conducted to determine glucose and leucine kinetics. Data are presented as mean ± SD or median (IQR); comparison was made by paired samples t test. Results Eleven subjects (age 5.1 (20.2) months) were studied 9.5 ± 1.9 hours post-cardiac surgery. Blood glucose concentrations were lower during LG than SG (LG 7.3 ± 0.7 vs. SG 9.3 ± 1.8 mmol/L; P < 0.01), although the glycemic target (4.0-6.0 mmol/L) was not achieved. No hypoglycemic events occurred. Endogenous glucose production was higher during LG than SG (LG 2.9 ± 0.8 vs. SG 1.5 ± 1.1 mg/kg per minute; P = 0.02), due to increased glycogenolysis (LG 1.0 ± 0.6 vs. SG 0.0 ± 1.0 mg/kg per minute; P < 0.05). Leucine balance, indicating protein balance, was negative but not affected by glucose intake (LG -54.8 ± 14.6 vs. SG -58.8 ± 16.7 μmol/kg per hour; P = 0.57). Conclusions Currently recommended glucose intakes aggravated hyperglycemia in children early after cardiac surgery with CPB. Reduced glucose intake decreased blood glucose concentrations without causing hypoglycemia or affecting protein catabolism, but increased glycogenolysis. Trial registration Dutch trial register NTR2079. PMID:23031354

  4. A Preliminary Pilot Randomized Crossover Study of Uzara (Xysmalobium undulatum) versus Ibuprofen in the Treatment of Primary Dysmenorrhea

    PubMed Central

    Abd-El-Maeboud, Karim H. I.; Kortam, Mohamed A. M. F.; Ali, Mohamed S.; Ibrahim, Mostafa I.; Mohamed, Radwa M. M. Z.

    2014-01-01

    Objective Preliminary evaluation of efficacy and safety of uzara use in treatment of moderate and severe primary dysmenorrhea in comparison to ibuprofen. Materials and Methods This randomized, comparative two way cross-over study comprised 60 single female students at Faculty of Medicine, Ain Shams University, Egypt, aged 19–28 years with moderate (n = 46) or severe (n = 14) primary dysmenorrhea. Participants were randomized to take either uzara (80 mg/8 hours for two doses, then 40 mg/8 hours) then ibuprofen (400 mg/6 hours) in two subsequent cycles or vice versa. The pain intensity, using VAS, was recorded immediately before taking the medication (0 hour) and after 4, 12, 24, 48–60, 96–120 hours. Main outcome measures included effectiveness of pain relief defined as drop of VAS to 3 or less, patient's global evaluation of the drug, absence from school, the use of a rescue medication, and, in those who continued the treatment, the pain intensity difference (PID) at different points after start of medication and its sum (SPID). Results Uzara was comparably effective to ibuprofen (78.3% vs. 86.7% of cycles; respectively), with comparable rates of effectiveness on global evaluation (being around 50% for either drug), and rates of school absences (11.7% vs. 13.3%; respectively). The need for rescue medication was different (18.3% and 10%; respectively), albeit with no statistical significance. The means of PID at different time points and SPID were comparable, with significantly lower average mean of VAS scores compared to that felt with no medication (1.6 vs. 6.8, p<0.001). Side effects were less with uzara than ibuprofen (0% vs. 8.3%, p<0.05). Conclusions Uzara might be as effective as ibuprofen in management of primary dysmenorrhea but with less side effects. These findings need to be confirmed by a properly designed trial with a larger sample size. Trial Registration Current Controlled Trials ISRCTN25618258 PMID:25119571

  5. Pharmacokinetics of etilevodopa compared to levodopa in patients with Parkinson's disease: an open-label, randomized, crossover study.

    PubMed

    Djaldetti, Ruth; Giladi, Nir; Hassin-Baer, Sharon; Shabtai, Hertzel; Melamed, Eldad

    2003-01-01

    "Dose failures" and "delayed on" phenomena following an intake of levodopa dose in patients with Parkinson's disease (PD) with motor fluctuations may be caused by stagnation of poorly soluble levodopa in the atonic stomach. Etilevodopa is a unique, highly soluble prodrug of levodopa. When ingested, etilevodopa is more readily dissolved in the stomach than levodopa. It passes unchanged through the stomach to the duodenum, where it is rapidly hydrolyzed by local esterases and rapidly absorbed as levodopa. To compare the pharmacokinetics of three different modes of etilevodopa/carbidopa administration with standard levodopa/carbidopa tablets in fluctuating PD patients, 29 patients with PD and response fluctuations were enrolled in an open-label, randomized, four-way crossover study of single doses of 4 treatments: swallowed etilevodopa/carbidopa tablets, etilevodopa/carbidopa tablets dissolved in water, etilevodopa oral solution with carbidopa tablets, and standard levodopa/carbidopa tablets. To measure the maximal concentration (Cmax), time to Cmax (tmax), and area under the curve (AUC) of plasma levodopa, etilevodopa, and carbidopa, blood samples were drawn before drug administration and at intervals up to 240 minutes thereafter. Plasma levodopa tmax was significantly shorter with all three modes of administration of etilevodopa (mean of about 30 minutes) than with levodopa treatment (mean of 54 minutes). During the first 45 minutes after drug ingestion, plasma levodopa AUC was significantly greater after etilevodopa administration than after levodopa administration. Levodopa AUC for 0 to 1 hour and 0 to 2 hours were also significantly greater following administration of etilevodopa/carbidopa swallowed tablets than following administration of levodopa/carbidopa tablets. Mean levodopa Cmax was in the range 2.3 to 2.7 microg/mL for all treatments. Levodopa Cmax was significantly greater following treatment with etilevodopa swallowed tablets than with levodopa tablets

  6. Melatonin treatment effects on adolescent students' sleep timing and sleepiness in a placebo-controlled crossover study.

    PubMed

    Eckerberg, Berndt; Lowden, Arne; Nagai, Roberta; Akerstedt, Torbjörn

    2012-11-01

    During the last few decades, the incidence of sleep-onset insomnia, due to delay of circadian phase, has increased substantially among adolescents all over the world. We wanted to investigate whether a small dose of melatonin given daily, administered in the afternoon, could advance the sleep timing in teenagers. Twenty-one students, aged 14-19 yrs, with sleep-onset difficulties during school weeks were recruited. The study was a randomized, double blind, placebo (PL)-controlled crossover trial, lasting 5 wks. During the first 6 d in wks 2 and 4, the students received either PL or melatonin (1 mg) capsules between 16:30 and 18:00 h. During the first 6 d of wk 5, all students received melatonin. Wks 1 and 3 were capsule-free. In the last evening of each week and the following morning, the students produced saliva samples at home for later melatonin analysis. The samples were produced the same time each week, as late as possible in the evening and as early as possible in the morning. Both the student and one parent received automatic mobile text messages 15 min before saliva sampling times and capsule intake at agreed times. Diaries with registration of presumed sleep, subjective sleepiness during the day (Karolinska Sleepiness Scale, KSS) and times for capsule intake and saliva samplings were completed each day. Primary analysis over 5 wks gave significant results for melatonin, sleep and KSS. Post hoc analysis showed that reported sleep-onset times were advanced after melatonin school weeks compared with PL school weeks (p < .005) and that sleep length was longer (p < .05). After the last melatonin school week, the students fell asleep 68 min earlier and slept 62 min longer each night compared with the baseline week. Morning melatonin values in saliva diminished compared with PL (p < .001) and evening values increased (p < .001), indicating a possible sleep phase advance. Compared with PL school weeks, the students reported less wake up (p < .05), less school

  7. 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

  8. [Ovarian stimulation by a new therapeutic principle for the treatment of complications of the climacteric. Results of a double-blind crossover study with a defined spleen dialysate].

    PubMed

    Möller, C P; Lübow, H; Schmitz, H

    1986-07-01

    In a placebo-controlled double-blind cross-over study (test period 8 weeks) the spleen dialysate Solcosplen is tested for effectiveness and tolerance in 40 women, i.e. 14 pre- resp. 26 postmenopausal women in two consecutive periods (test periods I and II). The treatment begins in the first week of each test period with 2 ampoules i.m. t.i.d. and is to be continued for the following 7 weeks with 2 dragees b.i.d. Besides the incidence of clinical symptoms there intensity is summarized in a graded form to the Kupperman index. For further objectifying the therapeutic results vaginal-cytological examinations and radioimmunological analyses of estradiol (E2), LH, FSH and DHEA-S are carried out. The courses of therapy are frequented on a balanced basis. The progress of clinical symptoms shows in respect of incidence of appearance and intensity measured in Kupperman index in Phase I as well as in the cross-over statistically clear reciprocity, which demonstrates - with homogeneous prefindings - significantly differing results of treatment in favour of the dialysate. In the intraindividual comparison of judging the effectiveness by the physician and patient yields significant preferences for the verum. Side-effects were not observed. The proven effectiveness of the spleen dialysate within this study is explained by the stimulation of the ovarian residual function during menopause. It is discussed and compared to the presently applied monotherapeutic E2-substitution. PMID:3533088

  9. A randomized phase II crossover study of imatinib or rituximab for cutaneous sclerosis after hematopoietic cell transplantation

    PubMed Central

    Arai, Sally; Pidala, Joseph; Pusic, Iskra; Chai, Xiaoyu; Jaglowski, Samantha; Khera, Nandita; Palmer, Jeanne; Chen, George L; Jagasia, Madan H; Mayer, Sebastian A; Wood, William A; Green, Michael; Hyun, Teresa S.; Inamoto, Yoshihiro; Storer, Barry E; Miklos, David B; Shulman, Howard M.; Martin, Paul J; Sarantopoulos, Stefanie; Lee, Stephanie J; Flowers, Mary E D

    2015-01-01

    Purpose Cutaneous sclerosis (CS) occurs in 20% of patients with chronic graft-versus-host disease (GVHD) and can compromise mobility and quality of life. Experimental design We conducted a prospective, multi-center, randomized, two-arm phase II crossover trial of imatinib (200 mg daily) or rituximab (375 mg/m2 intravenously weekly × 4 doses, repeatable after 3 months) for treatment of CS diagnosed within 18 months (NCT01309997). The primary endpoint was significant clinical response (SCR) at 6 months, defined as quantitative improvement in skin sclerosis or joint range of motion. Treatment success was defined as SCR at 6 months without crossover, recurrent malignancy or death. Secondary end points included changes of B cell profiles in blood (BAFF levels and cellular subsets), patient-reported outcomes, and histopathology between responders and non-responders with each therapy. Results SCR was observed in 9 of 35 (26%, 95% CI 13-43%) participants randomized to imatinib and 10 of 37 (27%, 95% CI 14-44%) randomized to rituximab. Six (17%, 95% CI 7-34%) patients in the imatinib arm and 5 (14%, 95% CI 5-29%) in the rituximab arm had treatment success. Higher percentages of activated B cells (CD27+) were seen at enrollment in rituximab-treated patients who had treatment success (p = 0.01), but not in imatinib-treated patients. Conclusion These results support the need for more effective therapies for CS and suggest that activated B cells define a subgroup of patients with CS who are more likely to respond to rituximab. PMID:26378033

  10. Lysine Clonixinate vs Naproxen Sodium for the Acute Treatment of Migraine: A Double-Blind, Randomized, Crossover Study

    PubMed Central

    Krymchantowski, Abouch Valenty; Peixoto, Patrícia; Higashi, Rafael; Silva, Ariovaldo; Schutz, Vivian

    2005-01-01

    Abstract and Introduction Abstract Background and Objectives The process of inflammation is crucial in migraine, and several nonsteroidal anti-inflammatory drugs (NSAIDs) are effective in the treatment of migraine attacks. Despite their efficacy, the routine use of NSAIDs is limited by side effects as well as incomplete efficacy in some patients. Among the available options, lysine clonixinate (LC) and naproxen sodium (NS) have proved effective in migraine. The aim of this study was to compare the efficacy and tolerability of oral formulations of LC and NS in the treatment of moderate or severe migraine attacks, with a double-blind, crossover design. Methods Seventy subjects (62 women, 8 men) between ages 18 and 71 years (mean age, 41) with migraine according to the criteria of the International Headache Society were prospectively enrolled. The patients were randomized into 2 groups and each participant treated 2 migraine attacks. Group 1 treated the first attack with LC and the second attack with NS. Group 2 treated 2 attacks in a counterbalanced order. Doses were 250 mg of LC or 550 mg of NS, which were encapsulated for equal appearance. Headache intensity, nausea, photophobia, and side effects were evaluated at baseline, 1 hour, and 2 hours after drug administration. Rescue drugs were allowed after 2 hours for those who didn't respond, and this was also compared between groups. Results Sixty patients (54 women, 6 men) completed the study. At 1 hour, 13.6% patients who used LC were pain-free compared with 11.9% who used NS (P = .78). At 2 hours, 35.6% patients who took LC and 32.2% who took NS were pain-free (P = .69). At baseline, 52.5% of the patients randomized to group 1 reported nausea, compared with 33.9% in group 2, and both drugs eliminated nausea: At both 1 hour and 2 hours, nausea diminished significantly for those taking LC, but only after 2 hours for those who took NS (P < .0001). Both drugs eliminated photophobia at 1 hour and 2 hours; however, LC

  11. 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.

  12. Stress Crossover in Newlywed Marriage: A Longitudinal and Dyadic Perspective

    ERIC Educational Resources Information Center

    Neff, Lisa A.; Karney, Benjamin R.

    2007-01-01

    Studies of stress and marital quality often assess stress as an intrapersonal phenomenon, examining how spouses' stress may influence their own relationship well-being. Yet spouses' stress also may influence partners' relationship evaluations, a phenomenon referred to as stress crossover. This study examined stress crossover, and conditions that…

  13. 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.

  14. Bilateral Repetitive Transcranial Magnetic Stimulation for Auditory Hallucinations in Patients with Schizophrenia: A Randomized Controlled, Cross-over Study

    PubMed Central

    Kim, Eun-Ji; Yeo, Seonguk; Hwang, Inho; Park, Jong-Il; Cui, Yin; Jin, Hong-Mei; Kim, Hyung Tae; Hwang, Tae-Young

    2014-01-01

    Objective A randomized double-blind cross-over trial was conducted in patients with persistent auditory hallucinations (AHs) to investigate whether bilateral repetitive transcranial magnetic stimulation (rTMS) at the temporoparietal area or Broca's area is more effective at high- or low-frequencies compared to a sham condition. Methods Twenty three patients with persistent AHs who remained stable on the same medication for 2 months were enrolled. They were randomized to one of four conditions: low-frequency (1 Hz)-rTMS to the temporoparietal area (L-TP), high-frequency (20 Hz)-rTMS to the temporoparietal area (H-TP), high-frequency (20 Hz)-rTMS to Broca's area (H-B), or sham. Results All the four rTMS conditions resulted in significant decrease in the scores under the auditory hallucination rating scale and hallucination change scale over time. However, there were no significant treatment effects or interaction between time and treatment, suggesting no superior effects of the new paradigms over the sham condition. Conclusion Our findings suggest that bilateral rTMS at the temporoparietal area or Broca's area with high- or low-frequency does not produce superior effects in reducing AHs compared to sham stimulation. PMID:25598827

  15. 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

  16. 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

  17. 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

  18. 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. PMID:26773784

  19. A proof-of-concept, randomized, placebo-controlled, multiple cross-overs (n-of-1) study of naftazone in Parkinson's disease.

    PubMed

    Rascol, Olivier; Ferreira, Joaquim; Nègre-Pages, Laurence; Perez-Lloret, Santiago; Lacomblez, Lucette; Galitzky, Monique; Lemarié, Jean-Christophe; Corvol, Jean-Christophe; Brotchie, Jonathan M; Bossi, Laura

    2012-08-01

    To explore for the first time the tolerability and efficacy of naftazone in patients with Parkinson's disease (PD). Proof-of-concept, randomized, double-blind, placebo-controlled, multiple-cross-over n-of-1 study in patients with PD with wearing-off and dyskinesias. Naftazone was titrated up to 120 mg/day during an initial single-blind dose-finding phase. Seven patients entered the placebo-controlled phase (four consecutive 28-day cross-overs). Three outcome measures were used to collect preliminary indices of efficacy: (i) 48-h ON-OFF diaries; (ii) Unified PD Rating Scale (UPDRS) part III while ON; (iii) seven-point Likert scale to assess "patients' discomfort caused by dyskinesias" (Q1) and 'disability during OFF-periods' (Q2). A 'responder' analysis (proportion of patients with mean treatment effect [naftazone minus placebo] favoring naftazone over the 4 cross-over periods) was used. Treatment effects were derived from mixed-effects anova. On diaries, 5/7 patients responded to naftazone for 'ON-time with troublesome dyskinesia' (reduced time, treatment effect: -49 [95% CI: -93/-4] min, P = 0.03), 6/7 regarding 'ON-time without troublesome dyskinesia' (increased time, treatment effect: 35 [-19/88], P = 0.2). No trend was observed for 'OFF' time. There were 7/7 'responders' regarding UPDRSIII (reduced score, treatment effect: -2.1[-4.5/0.2], P = 0.08). The 7-point scales did not show clear trends in favor of naftazone (3/7 responders for Q1 and 4/7 for Q2). Four of the seven patients reported adverse events after randomization, mostly related to the CNS (mild: 2, severe: 2). These pilot findings are consistent with preclinical data in primates and support the hypothesis that naftazone may have antiparkinsonian and antidyskinetic effects in humans that deserve further clinical investigation. PMID:21585523

  20. A double-blind placebo-controlled cross-over study of the vascular effects of midodrine in neuropathic compared with hyperadrenergic postural tachycardia syndrome

    PubMed Central

    ROSS, Amanda J.; OCON, Anthony J.; MEDOW, Marvin S.; STEWART, Julian M.

    2014-01-01

    POTS (postural tachycardia syndrome) is a chronic form of OI (orthostatic intolerance). Neuropathic POTS is characterized by decreased adrenergic vasoconstriction, whereas hyperadrenergic POTS exhibits increased adrenergic vasoconstriction. We hypothesized that midodrine, an α1-adrenergic receptor agonist, would increase CVR (calf vascular resistance), decrease Cv (calf venous capacitance) and decrease orthostatic tachycardia in neuropathic POTS, but not alter haemodynamics in hyperadrenergic POTS. A total of 20 POTS patients (12 neuropathic and 8 hyperadrenergic), ages 12–20 years, participated in this randomized placebo-controlled double-blind cross-over study. Of these subjects, 15 were female. POTS subjects received 2 weeks of treatment with midodrine or placebo, with increased dosing from 2.5 to 10 mg three times daily. Following a 7-day drug-washout period, subjects received the cross-over treatment. HR (heart rate), MAP (mean arterial pressure), Q̇calf (calf blood flow) and CVR were measured supine and during 35° HUT (head-up tilt). Cv was measured supine. In neuropathic POTS, midodrine decreased supine HR, Q̇calf, and Cv, while increasing MAP and CVR compared with placebo. During HUT, in neuropathic POTS, midodrine decreased HR, Q̇calf and Cv, while increasing MAP and CVR. In hyperadrenergic POTS, placebo and midodrine both decreased upright HR and increased supine CVR. Placebo also increased supine Cv, compared with midodrine in hyperadrenergic POTS. Therefore midodrine improved postural tachycardia in neuropathic POTS by increasing CVR and decreasing Q̇calf and Cv, whereas these effects were not seen in hyperadrenergic POTS patients who experienced a placebo effect. This suggests that midodrine is probably an effective treatment for neuropathic POTS, but not for hyperadrenergic POTS. PMID:23978222

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. Standard model cross-over on the lattice

    NASA Astrophysics Data System (ADS)

    D'Onofrio, Michela; Rummukainen, Kari

    2016-01-01

    With the physical Higgs mass the standard model symmetry restoration phase transition is a smooth cross-over. We study the thermodynamics of the cross-over using numerical lattice Monte Carlo simulations of an effective SU (2 )×U (1 ) gauge+Higgs theory, significantly improving on previously published results. We measure the Higgs field expectation value, thermodynamic quantities like pressure, energy density, speed of sound and heat capacity, and screening masses associated with the Higgs and Z fields. While the cross-over is smooth, it is very well defined with a width of only ˜5 GeV . We measure the cross-over temperature from the maximum of the susceptibility of the Higgs condensate, with the result Tc=159.5 ±1.5 GeV . Outside of the narrow cross-over region the perturbative results agree well with nonperturbative ones.

  6. Dynamic coupling-decoupling crossover in the current-driven vortex-state in Tl[sub 2]Ba[sub 2]CaCu[sub 2]O[sub 8]studied using terahertz time-domain spectroscopy

    SciTech Connect

    Thorsmølle, V. K.; Averitt, R. D.; Aranson, I. S.; Maley, M. P.; Bulaevskiĭ, L. N.; Taylor, Antoinette J.,

    2004-01-01

    Employing terahertz time-domain spectroscopy in transmission, they have measured the Josephson plasma resonance in Tl{sub 2}Ba{sub 2}CaCu{sub 2}O{sub 8} high-T{sub c} thin films, and studied the current-driven coupling-decoupling crossover in the driven vortex lattice.

  7. 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.

  8. 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…

  9. Dimensional crossover of nonrelativistic bosons

    NASA Astrophysics Data System (ADS)

    Lammers, Soeren; Boettcher, Igor; Wetterich, Christof

    2016-06-01

    We investigate how confining a transverse spatial dimension influences the few- and many-body properties of nonrelativistic bosons with pointlike interactions. Our main focus is on the dimensional crossover from three to two dimensions, which is of relevance for ultracold-atom experiments. Using functional-renormalization-group equations and T -matrix calculations we study how the phase transition temperature changes as a function of the spatial extent of the transverse dimension and relate the three- and two-dimensional s -wave scattering lengths. The analysis reveals how the properties of the lower-dimensional system are inherited from the higher-dimensional one during renormalization-group evolution. We limit the discussion to confinements in a potential well with periodic boundary conditions and argue why this qualitatively captures the physics of other compactifications such as transverse harmonic confinement as in cold-atom experiments.

  10. 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)

  11. 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

  12. A Randomized, Crossover, Single-Dose Bioequivalence Study of Two Extended-Release Tablets of Donepezil 23 mg in Healthy Human Volunteers under Fasting and Fed States

    PubMed Central

    Gadiko, Chaitanya; Tippabhotla, Sudhakar Koundinya; Thota, Satyanarayana; Battula, Ramakrishna; Khan, Sohel Md.; Vobalaboina, Venkateswarlu

    2013-01-01

    To assess the bioequivalence of two extended-release tablets of donepezil 23 mg, open label, randomized, single-dose, two-sequence, two-period crossover studies under fasting (n=74) and fed (n=94) conditions in healthy adult human volunteers were conducted. Subjects were randomized to either of the two treatment arms (test or reference) separated by a washout period of 28 days. Blood samples were collected up to 72 h post-dose and plasma samples were analyzed for donepezil using a validated LC-MS/MS method. Pharmacokinetic parameters were derived using a non-compartmental approach. Bioequivalence was evaluated in 69 subjects in the fasting study, and 71 subjects in the fed study. In the fasting study, the 90% CI of Cmax and AUC0-72 were 82.50–90.10 and 92.38–98.60, respectively. Corresponding values in the fed study were 91.82–98.05 and 97.27–100.27. Based on the results, the test product (donepezil) met the US regulatory criteria of bioequivalence relative to the reference product (Aricept®) under both fasting and fed conditions. PMID:24106673

  13. 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

  14. Fecal Lipid Excretion after Consumption of a Black Tea Polyphenol Containing Beverage-Randomized, Placebo-Controlled, Double-Blind, Crossover Study.

    PubMed

    Ashigai, Hiroshi; Taniguchi, Yoshimasa; Suzuki, Mihoko; Ikeshima, Emiko; Kanaya, Tomoka; Zembutsu, Kanako; Tomita, Shimpei; Miyake, Mika; Fukuhara, Ikuo

    2016-05-01

    Obesity is a serious medical condition worldwide. Inhibition of lipid absorption is very important in preventing obesity. In a previous study, we found that postprandial elevation of triacylglycerol was suppressed by the intake of black tea polyphenol (BTP). We also reported that BTP caused lipid excretion into feces in an animal study. The present study is a clinical trial that examined lipid excretion. In this randomized, placebo-controlled, double-blind, crossover study, in the first test period participants were asked to drink either a beverage containing 55 mg BTP or a control beverage without BTP 3 times a day for 10 d. After an 11-d interval, for the second test period, they then drank the alternate test beverage 3 times a day for 10 d. During the test periods, the participants were asked to eat meals standardized according to calorie and fat content. Stool samples were obtained during the last 3 d of each test period for fecal lipid measurements. Total lipid excretion increased from 5.51±1.73 to 6.87±1.91 g/3 d after BTP intake in comparison with intake of the control beverage. These results indicated that BTP increased lipid excretion. PMID:26887502

  15. 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

  16. Alcohol and risk of admission to hospital for unintentional cutting or piercing injuries at home: a population-based case-crossover study

    PubMed Central

    2011-01-01

    Background Cutting and piercing injuries are among the leading causes of unintentional injury morbidity in developed countries. In New Zealand, cutting and piercing are second only to falls as the most frequent cause of unintentional home injuries resulting in admissions to hospital among people aged 20 to 64 years. Alcohol intake is known to be associated with many other types of injury. We used a case-crossover study to investigate the role of acute alcohol use (i.e., drinking during the previous 6 h) in unintentional cutting or piercing injuries at home. Methods A population-based case-crossover study was conducted. We identified all people aged 20 to 64 years, resident in one of three regions of the country (Greater Auckland, Waikato and Otago), who were admitted to public hospital within 48 h of an unintentional non-occupational cutting or piercing injury sustained at home (theirs or another's) from August 2008 to December 2009. The main exposure of interest was use of alcohol in the 6-hour period before the injury occurred and the corresponding time intervals 24 h before, and 1 week before, the injury. Other information was collected on known and potential confounders. Information was obtained during face-to-face interviews with cases, and through review of their medical charts. Results Of the 356 participants, 71% were male, and a third sustained injuries from contact with glass. After adjustment for other paired exposures, the odds ratio for injury after consuming 1 to 3 standard drinks of alcohol during the 6-hour period before the injury (compared to the day before), compared to none, was 1.77 (95% confidence interval 0.84 to 3.74), and for four or more drinks was 8.68 (95% confidence interval 3.11 to 24.3). Smokers had higher alcohol-related risks than non-smokers. Conclusions Alcohol consumption increases the odds of unintentional cutting or piercing injury occurring at home and this risk increases with higher levels of drinking. PMID:22070787

  17. 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. PMID:26702788

  18. 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

  19. Event-Specific Risk Factors Predicting Episodes of Unprotected Anal Intercourse with Male Nonregular Partners among Men Who Have Sex with Men Using Case-Crossover Study Design

    PubMed Central

    Li, Jinghua; Lau, Joseph T. F.; Gu, Jing; Hao, Chun; Lai, Coco H. Y.

    2014-01-01

    This study investigated event-specific factors that determine episodes of unprotected and protected anal intercourse (UAI and PAI) among 215 men who have sex with men (MSM), who used condoms inconsistently with nonregular partners (NRP) in the last six months, in Hong Kong. A case-crossover study design was used. Lower likelihood of episodes involving UAI with NRP was associated with (1) five partner attributes (NRP were <35 years old, at least three previous anal sex experiences with the NRP, perception that participant and the NRP had asymmetrical sexual experience, perception that the NRP was feminine, and liking toward the NRP; OR = 0.16–0.52), (2) six situational variables (the participant having had UAI with another man in the last week, having discussed condom use, perception that the NRP liked to use condom, partner's suggestion to have PAI, participant's suggestion to have PAI, and participant's plan to use condoms; OR = 0.11–0.39), and (3) four environmental/setting variables (condoms already placed at the venue, display of condom use promotion materials, participant's possession of a condom, and the NRP possessed a condom; OR = 0.27–0.45). HIV prevention targeting MSM should focus on event-specific protective factors, which may be different from those obtained from studies distinguishing condom users versus nonusers. PMID:25136589

  20. Aperitif effects on gastric emptying: a crossover study using continuous real-time 13C breath test (BreathID System).

    PubMed

    Inamori, M; Iida, H; Endo, H; Hosono, K; Akiyama, T; Yoneda, K; Fujita, K; Iwasaki, T; Takahashi, H; Yoneda, M; Goto, A; Abe, Y; Kobayashi, N; Kubota, K; Nakajima, A

    2009-04-01

    The aim of this study was to determine whether there is a correlation between aperitif and gastric emptying. Ten healthy male volunteers participated in this randomized, two-way crossover study. Under two conditions (after drinking an aperitif versus not), the (13)C breath test was performed for 4 h with a liquid meal (200 kcal/200 ml) containing 100 mg (13)C acetate. We used 50 ml of umeshu as the aperitif. This is a traditional Japanese plum liqueur, and contains 7 ml alcohol (14%). In the aperitif group, T(1/2), T(lag), and T(peak) were significantly delayed [T(1/2) (132: 113-174) versus (112: 92-134) (P = 0.0069); T(lag) (80: 63-94) versus (55: 47-85) (P = 0.0069); and T(peak) (81: 62-96) versus (54: 34-84) (P = 0.0069), (median: range, aperitif versus control, min)]. Gastric emptying was significantly delayed in the aperitif group as compared with the control group. This study revealed that even a small amount of alcohol such as an aperitif may contribute to delayed gastric emptying. PMID:18688714

  1. 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

  2. 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

  3. 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

  4. [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

  5. 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

  6. 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

  7. Short-term effects of fine particulate air pollution on hospital admissions for cardiovascular diseases: a case-crossover study in a tropical city.

    PubMed

    Chang, Chih-Ching; Chen, Pei-Shih; Yang, Chun-Yuh

    2015-01-01

    This study was undertaken to determine whether there was an association between fine particles (PM2.5) levels and hospital admissions for cardiovascular diseases (CVD) in Kaohsiung, Taiwan. Hospital admissions for CVD (including ischemic heart disease [IHD], stroke, congestive heart failure [CHF], and arrhythmias) and ambient air pollution data for Kaohsiung were obtained for the period from 2006-2010. The relative risk of hospital admissions for CVD 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), elevated number of admissions for CVD were significantly associated with higher PM2.5 levels only on cool days (<25°C), with an interquartile range rise associated with a 47% (95% CI = 39-56%), 48% (95% CI = 40-56%), 47% (95% CI = 34-61%), and 51% (95% CI = 34-70%) increase in IHD, stroke, CHF, and arrhythmias admissions, respectively. No significant associations between PM2.5 and hospital admissions for CVD were observed on warm days. In the two-pollutant models, PM2.5 levels remained significant even controlling for sulfur dioxide, nitrogen dioxide, carbon monoxide, or ozone on cool days. This study provides evidence that higher levels of PM2.5 enhance the risk of hospital admissions for CVD in Kaohsiung, Taiwan. PMID:25674828

  8. 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

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

    PubMed Central

    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

  10. Bioequivalence study of two subcutaneous formulations of dalteparin: randomized, single-dose, two-sequence, two-period, cross-over study in healthy volunteers

    PubMed Central

    Gadiko, C.; Tippabhotla, S. K.; Thota, S.; Nakkawar, M.; Cheerla, R.; Betha, M.R.; Vobalaboina, V.

    2013-01-01

    Objective This study assessed relative bioavailability of a new subcutaneous formulation, test (T) (dalteparin sodium 95000 IU/3.8 mL) with the branded product (R) in healthy subjects to meet the regulatory requirements of bioequivalence in the US. Methods This was an open label, randomized, single dose, two-sequence, two-period cross-over study under fasting conditions. A total of 88 healthy adult volunteers were randomized to either of the treatment arms (T or R) separated by a washout period of 7 days. Pharmacodynamic surrogates, namely anti-Xa and anti-IIa activity, heparin clotting assay (heptest), and activated partial thromboplastin time (aPTT) were used as a tool to establish bioequivalence between these two formulations. Blood samples were collected up to 36 h post-dose to characterize the primary pharmacokinetic parameters Amax, AUC0–t, and AUC0–∞ for anti-Xa and anti-IIa and heptest; parameters (Δt )max and AU(Δt ) for aPTT. Results For anti-Xa activity, the means (SD) of Amax (IU/mL) were 1.34 (0.25) [range = 0.59–2.03] and 1.39 (0.35) [range = 0.65–2.69]; AUC0–t (IU•h/mL) values were 11.4 (2.76) [range = 2.89–19.5] and 12.1 (2.87) [range = 2.52–21.30]; AUC0–∞ (IU•h/mL) values were 13.1 (3.59) [range = 3.15–28.2] and 14.5 (4.97) [range = 2.79–36.1] for test and branded formulations, respectively. For anti-IIa activity, the means (SD) of Amax (IU/mL) were 0.34 (0.12) [range = 0.14–0.72] and 0.34 (0.13) [range = 0.11–0.84]; AUC0–t (IU•h/mL) values were 2.05 (0.72) [range = 0.61–4.69] and 2.11 (0.76) [range = 0.84–4.80]; AUC0–∞ (IU•h/mL) values were 2.47 (0.80) [range = 0.76–6.29] and 2.61 (0.86) [range = 1.31–5.36], for test and branded formulations, respectively. The 90% CI for all the primary pharmacokinetic parameters of all the pharmacodynamic surrogates tested met the regulatory bioequivalence criterion of 80.00–125.00%. Conclusion The test

  11. Evaluation of the absolute oral bioavailability and bioequivalence of erlotinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in a randomized, crossover study in healthy subjects.

    PubMed

    Frohna, Paul; Lu, Jianfeng; Eppler, Steve; Hamilton, Marta; Wolf, Julie; Rakhit, Ashok; Ling, Jie; Kenkare-Mitra, Saraswati R; Lum, Bert L

    2006-03-01

    A randomized, open-label, 2-period crossover study was conducted to evaluate the bioequivalence of 6 tablets of erlotinib 25 mg and 1 tablet of erlotinib 150 mg (arm A, n = 42) and the oral bioavailability of the 150-mg tablet versus a 25-mg intravenous infusion (arm B, n = 20) in healthy subjects. The washout period was 2 weeks between treatments. Plasma concentrations of erlotinib and its active metabolite, OSI-420, were measured after each dose. The ratios of geometric means for AUC(0-infinity) and Cmax of erlotinib following 6 tablets of erlotinib 25 mg and 1 tablet of erlotinib 150 mg were (1 and 0.95) within the predefined bioequivalence range of 0.80 to 1.25. The mean absolute oral bioavailability, using compartmental analysis, was estimated as 59% (95% confidence interval, 55%-63%). Overall, 6 tablets of erlotinib 25 mg are bioequivalent to a single 150-mg tablet. Both intravenous and oral erlotinib were generally well tolerated with an estimated bioavailability of 59% following oral administration. PMID:16490804

  12. 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

  13. Effects on fetal breathing movements of maternal challenges. Cross-over study on dynamic work, static work, passive movements, hyperventilation and hyperoxygenation.

    PubMed

    Marsál, K; Gennser, G; Löfgren, O

    1979-01-01

    Ten women in the last trimester of a normal pregnancy were subjected to five different loads in a cross-over study. Fetal breathing movements (FBM), fetal heart rate (FHR), maternal heart rate (MHR), and mean arterial pressure (MAP), maternal transcutaneously measured pO2 (Tc-pO2), and the energy supply to the Tc-pO2 electrode were recorded continuously before, during, and after the load. Maternal capillary pH and pCO2 were measured at three representative time points. The immediate responses of the incidence of FBM to the different challenges were: increase after dynamic work (bicycle test); no change after static work (isometric muscle contraction) and passive movements; decrease after hyperventilation and hyperoxygenation. FHR was unaffected by all challenges. The FBM incidence varied in parallel with pCO2 after dynamic work and hyperventilation and inversely with the Tc-pO2 rise caused by hyperoxygenation. Maternal pH was increased after passive movements (no change in FBM) and after hyperventilation (decreased incidence of FBM), FBM seem to be more sensitive to environmental changes than is the FHR. Mechanical stimuli to the uterus were not responsible for the augmentation of FMB seen after the bicycle test. The present observations reveal the multifactorial nature of the regulation of FBM, and support the role of CO2 as a major stimulator of breathing movements also in prenatal life. PMID:43068

  14. Synthesis of Nanocrystals and Particle Size Effects Studies on the Thermally Induced Spin Transition of the Model Spin Crossover Compound [Fe(phen)2(NCS)2].

    PubMed

    Valverde-Muñoz, Francisco Javier; Gaspar, Ana B; Shylin, Sergii I; Ksenofontov, Vadim; Real, José A

    2015-08-17

    Surfactant-free nanocrystals of the model spin-crossover compound [Fe(phen)2(NCS)2] (phen: 1,10-phenanthroline) have been synthesized applying the reverse micelle technique. The morphology of the nanocrystals, characterized by scanning electronic microscopy, corresponds to rhombohedric platelets with dimensions ranging from 203 × 203 × 106 nm to 142 × 142 × 74 nm. Variation of the concentration of the Fe(BF4)2·6H2O salt in the synthesis has been found to have little influence on the crystallite size. In contrast, the solvent-surfactant ratio (ω) is critical for a good particle growth. The spin transition of the nanocrystals has been characterized by magnetic susceptibility measurements and Mössbauer spectroscopy. The nanocrystals undergo an abrupt and more cooperative spin transition in comparison with the bulk compound. The spin transition is centered in the interval of temperature of 175-185 K and is accompanied by 8 K of thermal hysteresis width. The crystallite quality more than the crystallite size is responsible for the higher cooperativity. The magnetic properties of the nanocrystals embedded in organic polymers such as polyethylene glycol, nujol, glycerol, and triton have been studied as well. The spin transition in the nanocrystals is affected by the polymer coating. The abrupt and first-order spin transition transforms into a more continuous spin transition as a result of the chemical pressure asserted by the organic polymers on the Fe(II) centers. PMID:26208031

  15. 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

  16. 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. PMID:26017321

  17. The relationship between changes in daily air pollution and hospitalizations in Perth, Australia 1992-1998: a case-crossover study.

    PubMed

    Hinwood, A L; De Klerk, N; Rodriguez, C; Jacoby, P; Runnion, T; Rye, P; Landau, L; Murray, F; Feldwick, M; Spickett, J

    2006-02-01

    A case-crossover study was undertaken to investigate the relationship between daily air pollutant concentrations and daily hospitalizations for selected disease categories in Perth, Western Australia. Daily measurements of particles (measured by nephelometry and PM2.5), photochemical oxidants (measured as ozone), nitrogen dioxide (NO2) and carbon monoxide (CO) concentrations were obtained from 1992 to 1998 via a metropolitan network of monitoring stations. Daily PM2.5 concentrations were estimated using monitored data, modelling and interpolation. Hospital morbidity data for respiratory, cardiovascular (CVD), gastrointestinal (GI) diseases, chronic obstructive pulmonary diseases (COPD) excluding asthma; pneumonia/influenza diseases; and asthma were obtained and categorized into all ages, less than 15 years and greater than 65 years. Gastrointestinal morbidity was used as a control disease. The data were analyzed using conditional logistic regression. The results showed a small number of significant associations for daily changes in particle concentrations, nitrogen dioxide and carbon monoxide for the respiratory diseases, CODP, pneumonia, asthma and CVD hospitalizations. Changes in ozone concentrations were not significantly associated with any disease outcomes. These data provide useful information on the potential health impacts of air pollution in an airshed with very low sulphur dioxide concentrations and lower nitrogen dioxide concentrations commonly found in many other cities. PMID:16507479

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

    PubMed Central

    Seitsalo, Hubertus; Niemelä, Raija K; Marinescu-Gava, Magdalena; Vuotila, Tuija; Tjäderhane, Leo; Salo, Tuula

    2007-01-01

    Background Matrix metalloproteinases (MMPs) are proteolytic enzymes that may contribute to tissue destruction in Sjögren's syndrome (SS). Low-dose doxycycline (LDD) inhibits MMPs. We evaluated the efficacy of LDD for the subjective symptoms in primary SS patients. This was a randomized, double blind, placebo controlled cross-over study. 22 patients were randomly assigned to receive either 20 mg LDD or matching placebo twice a day for 10 weeks. The first medication period was followed by 10-week washout period, after which the patient received either LDD or placebo, depending on the first drug received, followed by the second washout period. Stimulated saliva flow rates and pH were measured before and after one and ten weeks of each medication and after washout periods. VAS scale was used to assess the effect of LDD and placebo on following six subjective symptoms: xerostomia; xerophtalmia; difficulty of swallowing; myalgia; arthralgia; and fatigue. The effect was evaluated for each medication and washout period separately. Results Overall, the effects of medications on subjective symptoms were minor. Wilcoxon test demonstrated increased fatigue with LDD during medication (p < 0.05). The differences may, however, reflect normal fluctuation of symptoms in SS patients. Conclusion LDD may not be useful in reducing the primary SS symptoms. PMID:18163919

  19. Effect of lean red meat from lamb v. lean white meat from chicken on the serum lipid profile: a randomised, cross-over study in women.

    PubMed

    Mateo-Gallego, Rocio; Perez-Calahorra, Sofia; Cenarro, Ana; Bea, Ana M; Andres, Eva; Horno, Jaime; Ros, Emilio; Civeira, Fernando

    2012-05-01

    The main dietary guidelines recommend restricting total and saturated fat intake in the management of high blood cholesterol levels for cardiovascular risk. These recommendations are usually oversimplified by considering that all red meats should be limited and replaced by white meats. However, lean red meat can be as low in fat as white meat. We examined the effects of red meat (lean breed lamb) and lean white meat (chicken) intake on the lipid profile of a group of women with stable life conditions (nuns living in convents). An open-label, randomised, cross-over study was carried out in thirty-six nuns who consumed either lamb or chicken three times per week for 5-week periods with their usual diet. Clinical, dietary and biochemical variables were evaluated at baseline and the end of each diet period. A validated FFQ was used to assess nutrient intake and monitor compliance. The results showed neither between-diet differences in lipid responses nor differences from baseline in total cholesterol, LDL-cholesterol or TAG for any diet period. In conclusion, consumption of lean red meat (lamb) or lean white meat (chicken) as part of the usual diet is associated with a similar lipid response. These two foods can be exchanged in a healthy diet to increase palatability. PMID:21902857

  20. 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

  1. Doxycycline-mediated effects on persistent symptoms and systemic cytokine responses post-neuroborreliosis: a randomized, prospective, cross-over study

    PubMed Central

    2012-01-01

    Background Persistent symptoms after treatment of neuroborreliosis (NB) are well-documented, although the causative mechanisms are mainly unknown. The effect of repeated antibiotic treatment has not been studied in detail. The aim of this study was to determine whether: (1) persistent symptoms improve with doxycycline treatment; (2) doxycycline has an influence on systemic cytokine responses, and; (3) improvement of symptoms could be due to doxycycline-mediated immunomodulation. Methods/Design 15 NB patients with persistent symptoms ≥6 months post-treatment were double-blindly randomized to receive 200 mg of doxycycline or a placebo for three weeks. After a six-week wash-out period, a cross-over with a three-week course of a placebo or doxycycline was conducted. The primary outcome measures were improvement of persistent symptoms assessed by neurological examinations, a symptom severity score and estimation of the quality of life. The secondary outcome measure was changes in systemic cytokine responses. Results All 15 patients finished the study. No doxycycline-mediated improvement of post-treatment symptoms or quality of life was observed. Nor could any doxycycline-mediated changes in systemic cytokine responses be detected. The study was completed without any serious adverse events. Discussion No doxycycline-mediated improvement of post-treatment symptoms or quality of life was observed. Nor could any doxycycline-mediated changes in systemic cytokine responses be detected. The study was completed without any serious adverse events. To conclude, in this pilot study, doxycycline-treatment did not lead to any improvement of either the persistent symptoms or quality of life in post-NB patients. Accordingly, doxycycline does not seem to be the optimal treatment of diverse persistent symptoms post-NB. However, the results need to be confirmed in larger studies. Trial registration NCT01205464 (clinicaltrials.gov) PMID:22876748

  2. Gaviscon Double Action Liquid (antacid & alginate) is more effective than antacid in controlling postprandial esophageal acid exposure in GERD patients; a double-blind crossover study

    PubMed Central

    De Ruigh, Annemijn; Roman, Sabine; Chen, Joan; Pandolfino, John E.; Kahrilas, Peter J.

    2015-01-01

    Background Recent studies have shown that Gaviscon Double Action Liquid (a combination alginate-antacid) administered postprandially co-localizes with the acid pocket, the ‘reservoir’ for postprandial acid reflux. Aim This study compared the effectiveness of Gaviscon Double Action Liquid to an equivalent strength antacid without alginate in controlling postprandial acid reflux in GERD patients. Methods 14 GERD patients undertook two 3.5-hour high-resolution manometry/pH-impedance studies during which they ate a standardized meal. In a double-blinded randomized crossover design they then took Gaviscon or CVS brand antacid, each with ~18 mmol/l acid neutralizing capacity. The primary outcome was distal esophageal acid exposure; secondary outcomes were number of reflux events, proximal extent of reflux, nadir pH of the refluxate, mechanism of reflux, and reflux symptoms scored with a validated instrument. Results 10 patients completed the study. Gaviscon studies had significantly less distal esophageal acid exposure and greater nadir refluxate pH in the 30–150 minute postprandial period than antacid studies. There were no differences in the number of reflux events (acid or weakly acidic) or the number of proximal reflux events (15–17 cm above the LES) with either study medication. Conclusions Gaviscon Double Action Liquid was more effective than an antacid without alginate in controlling postprandial esophageal acid exposure. However, the number and spatial distribution of reflux events within the esophagus were similar. This suggests that Gaviscon main effectiveness related to its co-localization with and displacement/neutralization of the post-prandial acid pocket, rather than preventing reflux. PMID:25041141

  3. Efficacy of frovatriptan versus other triptans in the acute treatment of menstrual migraine: pooled analysis of three double-blind, randomized, crossover, multicenter studies.

    PubMed

    Allais, Gianni; Tullo, Vincenzo; Omboni, Stefano; Benedetto, Chiara; Sances, Grazia; Zava, Dario; Ferrari, Michel D; Bussone, Gennaro

    2012-05-01

    The objective of this study was to review the efficacy and safety of frovatriptan (F) versus rizatriptan (R), zolmitriptan (Z) and almotriptan (A), in women with menstrually related migraine (IHS criteria) through a pooled analysis of three individual studies. Subjects with a history of migraine with or without aura were randomized to F 2.5 mg or R 10 mg (study 1), F or Z 2.5 mg (study 2), and F or A 12.5 mg (study 3). The studies had an identical multicenter, randomized, double-blind, crossover design. After treating three episodes of migraine in no more than 3 months with the first treatment, patients had to switch to the next treatment for other 3 months. 346 subjects formed intention-to-treat population of the main study; 280 of them were of a female gender, 256 had regular menses and 187 were included in the menstrual migraine subgroup analysis. Rate of pain free at 2, 4 and 24 h was 23, 52 and 67 % with F and 30, 61 and 66 % with comparators (P = NS). Pain relief episodes at 2, 4 and 24 h were 37, 60 and 66 % for F and 43, 55 and 61 % for comparators (P = NS). Rate of recurrence was significantly (P < 0.05) lower under F either at 24 h (11 vs. 24 % comparators) or at 48 h (15 vs. 26 % comparators). Number of menstrual migraine attacks associated with drug-related adverse events was equally low (P = NS) between F (5 %) and comparators (4 %). PMID:22644174

  4. Frovatriptan versus other triptans in the acute treatment of migraine: pooled analysis of three double-blind, randomized, cross-over, multicenter, Italian studies.

    PubMed

    Cortelli, Pietro; Allais, Gianni; Tullo, Vincenzo; Benedetto, Chiara; Zava, Dario; Omboni, Stefano; Bussone, Gennaro

    2011-05-01

    The objective of the study is to systematically review the efficacy and safety of frovatriptan (F) versus rizatriptan (R), zolmitriptan (Z) and almotriptan (A), through a pooled analysis of three individual studies. 414 subjects with a history of migraine with or without aura (IHS criteria) were randomized to F 2.5 mg or R 10 mg (study 1), F 2.5 mg or Z 2.5 mg (study 2), and F 2.5 mg or A 12.5 mg (study 3). The studies had an identical multicenter, randomized, double blind, cross-over design, with each of the two treatment periods lasting not more than 3 months. The number of pain free (PF) and pain relief (PR) episodes at 2 h, and the number of sustained pain free (SPF) and recurrent episodes within the 48 h were the efficacy endpoints. 346 patients were included in the intention-to-treat analysis. Rate of PF episodes at 2 h was 30% with F and 34% with comparators (p = NS). PR episodes at 2 h were 55% for F and 59% for comparators (p = NS). SPF episodes at 48 h were also similar between the two groups (22% F vs. 21% comparators). Rate of recurrence was significantly (p < 0.001) lower under F (27 vs. 40% comparators). Drug-related adverse events were significantly (p < 0.05) less under F, particularly cardiovascular symptoms. Our systematic analysis of individual studies suggests that F has a similar immediate efficacy, but a more sustained effect and a better tolerability than R, Z and A. PMID:21533722

  5. The interleukin 1 inhibitor rilonacept in treatment of chronic gouty arthritis: results of a placebo-controlled, monosequence crossover, non-randomised, single-blind pilot study

    PubMed Central

    Terkeltaub, R; Sundy, J S; Schumacher, H R; Murphy, F; Bookbinder, S; Biedermann, S; Wu, R; Mellis, S; Radin, A

    2009-01-01

    Background: Recent studies suggest that blockade of the NLRP3 (cryopyrin) inflammasome interleukin 1β (IL1β) pathway may offer a new treatment strategy for gout. Objective: To explore the potential utility of rilonacept (IL1 Trap) in patients with chronic active gouty arthritis in a proof-of-concept study. Methods: This 14-week, multicentre, non-randomised, single-blind, monosequence crossover study of 10 patients with chronic active gouty arthritis included a placebo run-in (2 weeks), active rilonacept treatment (6 weeks) and a 6-week post-treatment follow-up. Results: Rilonacept was generally well tolerated. No deaths and no serious adverse events occurred during the study. One patient withdrew owing to an injection-site reaction. Patients’ self-reported median pain visual analogue scale scores significantly decreased from week 2 (after the placebo run-in) to week 4 (2 weeks of rilonacept) (5.0 to 2.8; p<0.049), with sustained improvement at week 8 (1.3; p<0.049); 5 of 10 patients reported at least a 75% improvement. Median symptom-adjusted and severity-adjusted joint scores were significantly decreased. High-sensitivity C-reactive protein levels fell significantly. Conclusions: This proof-of-concept study demonstrated that rilonacept is generally well tolerated and may offer therapeutic benefit in reducing pain in patients with chronic refractory gouty arthritis, supporting the need for larger, randomised, controlled studies of IL1 antagonism such as with rilonacept for this clinical indication. PMID:19635719

  6. 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.

  7. The Analgesic Effect of Oxytocin in Humans: A Double-Blind, Placebo-Controlled Cross-Over Study Using Laser-Evoked Potentials.

    PubMed

    Paloyelis, Y; Krahé, C; Maltezos, S; Williams, S C; Howard, M A; Fotopoulou, A

    2016-04-01

    Oxytocin is a neuropeptide regulating social-affiliative and reproductive behaviour in mammals. Despite robust preclinical evidence for the antinociceptive effects and mechanisms of action of exogenous oxytocin, human studies have produced mixed results regarding the analgesic role of oxytocin and are yet to show a specific modulation of neural processes involved in pain perception. In the present study, we investigated the analgesic effects of 40 IU of intranasal oxytocin in 13 healthy male volunteers using a double-blind, placebo-controlled, cross-over design and brief radiant heat pulses generated by an infrared laser that selectively activate Aδ- and C-fibre nerve endings in the epidermis, at the same time as recording the ensuing laser-evoked potentials (LEPs). We predicted that oxytocin would reduce subjective pain ratings and attenuate the amplitude of the N1, N2 and P2 components. We observed that oxytocin attenuated perceived pain intensity and the local peak amplitude of the N1 and N2 (but not of P2) LEPs, and increased the latency of the N2 component. Importantly, for the first time, the present study reports an association between the analgesic effect of oxytocin (reduction in subjective pain ratings) and the oxytocin-induced modulation of cortical activity after noxious stimulation (attenuation of the N2 LEP). These effects indicate that oxytocin modulates neural processes contributing to pain perception. The present study reports preliminary evidence that is consistent with electrophysiological studies in rodents showing that oxytocin specifically modulates Aδ/C-fibre nociceptive afferent signalling at the spinal level and provides further specificity to evidence obtained in humans indicating that oxytocin may be modulating pain experience by modulating activity in the cortical areas involved in pain processing. PMID:26660859

  8. 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

  9. Is there an ideal way to initiate antiplatelet therapy with aspirin? A crossover study on healthy volunteers evaluating different dosing schemes with whole blood aggregometry

    PubMed Central

    2011-01-01

    Background Guidelines recommend an early initiation of aspirin treatment in patients with acute cerebral ischemia. Comparative studies on the best starting dose for initiating aspirin therapy to achieve a rapid antiplatelet effect do not exist. This study evaluated the platelet inhibitory effect in healthy volunteers by using three different aspirin loading doses to gain a model for initiating antiplatelet treatment in acute strokes patients. Methods Using whole blood aggregometry, this study with a prospective, uncontrolled, open, crossover design examined 12 healthy volunteers treated with three different aspirin loading doses: intravenous 500 mg aspirin, oral 500 mg aspirin, and a course of 200 mg aspirin on two subsequent days followed by a five-day course of 100 mg aspirin. Aspirin low response was defined as change of impedance exceeding 0 Ω after stimulation with arachidonic acid. Results Sufficient antiplatelet effectiveness was gained within 30 seconds when intravenous 500 mg aspirin was used. The mean time until antiplatelet effect was 74 minutes for 500 mg aspirin taken orally and 662 minutes (11.2 hours) for the dose scheme with 200 mg aspirin with a high inter- and intraindividual variability in those two regimes. Platelet aggregation returned to the baseline range during the wash-out phase within 4 days. Conclusion Our study reveals that the antiplatelet effect differs significantly between the three different aspirin starting dosages with a high inter- and intraindividual variability of antiplatelet response in our healthy volunteers. To ensure an early platelet inhibitory effect in acute stroke patients, it could be advantageous to initiate the therapy with an intravenous loading dose of 500 mg aspirin. However, clinical outcome studies must still define the best way to initiate antiplatelet treatment with aspirin. PMID:21466682

  10. Frovatriptan vs. other triptans for the acute treatment of oral contraceptive-induced menstrual migraine: pooled analysis of three double-blind, randomized, crossover, multicenter studies.

    PubMed

    Allais, G; Tullo, V; Omboni, S; Pezzola, D; Zava, D; Benedetto, C; Bussone, G

    2013-05-01

    Oral contraceptive-induced menstrual migraine (OCMM) is a particularly severe form of migraine triggered by the cyclic hormone withdrawal. To review the efficacy of frovatriptan vs. other triptans, in the acute treatment of OCMM through a pooled analysis of three individual randomized Italian studies. With or without aura migraineurs were randomized to frovatriptan 2.5 mg or rizatriptan 10 mg (study 1), frovatriptan 2.5 mg or zolmitriptan 2.5 mg (study 2), frovatriptan 2.5 mg or almotriptan 12.5 mg (study 3). All studies had a multicenter, randomized, double-blind, crossover design. After treating 1-3 episodes of migraine in 3 months with the first treatment, patients switched to the other treatment for the next 3 months. In this analysis, the subset of 35 of the 280 women of the intention-to-treat population taking combined oral contraceptives and experiencing a migraine attack during the withdrawal phase, were analyzed. The proportion of pain free and pain relief at 2 h were 25 and 51 % with frovatriptan and 28 and 48 % with comparators (p = NS). At 24 h, 71 and 83 % of frovatriptan-treated patients and 60 and 76 % of comparator-treated patients were pain free (p < 0.05 between treatments) and had pain relief (p = NS), respectively. Relapse at 24 and 48 h was significantly (p < 0.05) lower with frovatriptan (17 and 21 %) than with the comparators (27 and 31 %). Our results suggest that, due to its sustained antimigraine effect, frovatriptan may be particularly suitable for the management of OCMM than other triptans. PMID:23695052

  11. 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

  12. Effects of ultrafine particles on the allergic inflammation in the lung of asthmatics: results of a double-blinded randomized cross-over clinical pilot study

    PubMed Central

    2014-01-01

    Background Epidemiological and experimental studies suggest that exposure to ultrafine particles (UFP) might aggravate the allergic inflammation of the lung in asthmatics. Methods We exposed 12 allergic asthmatics in two subgroups in a double-blinded randomized cross-over design, first to freshly generated ultrafine carbon particles (64 μg/m3; 6.1 ± 0.4 × 105 particles/cm3 for 2 h) and then to filtered air or vice versa with a 28-day recovery period in-between. Eighteen hours after each exposure, grass pollen was instilled into a lung lobe via bronchoscopy. Another 24 hours later, inflammatory cells were collected by means of bronchoalveolar lavage (BAL). (Trial registration: NCT00527462) Results For the entire study group, inhalation of UFP by itself had no significant effect on the allergen induced inflammatory response measured with total cell count as compared to exposure with filtered air (p = 0.188). However, the subgroup of subjects, which inhaled UFP during the first exposure, exhibited a significant increase in total BAL cells (p = 0.021), eosinophils (p = 0.031) and monocytes (p = 0.013) after filtered air exposure and subsequent allergen challenge 28 days later. Additionally, the potential of BAL cells to generate oxidant radicals was significantly elevated at that time point. The subgroup that was exposed first to filtered air and 28 days later to UFP did not reveal differences between sessions. Conclusions Our data demonstrate that pre-allergen exposure to UFP had no acute effect on the allergic inflammation. However, the subgroup analysis lead to the speculation that inhaled UFP particles might have a long-term effect on the inflammatory course in asthmatic patients. This should be reconfirmed in further studies with an appropriate study design and sufficient number of subjects. PMID:25204642

  13. A comparison of triclosan and stannous fluoride toothpastes for inhibition of plaque regrowth. A crossover study designed to assess carry over.

    PubMed

    Binney, A; Addy, M; Owens, J; Faulkner, J

    1997-03-01

    Some triclosan and stannous fluoride toothpastes have been shown effective in reducing plaque and more particularly gingivitis in home use studies. There have been few comparisons of such products for their chemical plaque inhibitory action divorced from the indeterminate variable of toothbrushing. This study was a randomised, single-blind, cross-over comparison of 4 products, in a 4-day plaque regrowth design, balanced for residual effects and involving 12 healthy dentate subjects. The test agents were a stannous fluoride toothpaste, a triclosan/copolymer toothpaste, a triclosan/zinc citrate toothpaste and water. On day 1 of each study period, subjects were rendered plaque free. For the following 4 days, each subject suspended normal toothcleaning and rinsed 2 x daily with the allocated treatment for 60 s under supervision. On day 5, plaque was scored by index. Washout periods of 2 1/2 days brushing with water alone, followed each treatment period. Pseudo treatment periods of 4 days, involving 2 x daily rinsing with water in the absence of toothbrushing, followed the normal washouts after the stannous fluoride and triclosan/zinc citrate treatments, giving a total of 6 treatment periods. This design permitted analyses for 1st-order-carry-over. Intention to treat analyses revealed all toothpastes were more effective than water but that there were no differences between the active treatments. Per protocol analysis gave essentially similar findings except that the difference in plaque in favour of the triclosan/zinc citrate toothpaste over water did not reach significance. There was no evidence of 1st-order-carry-over effects for the stannous fluoride or triclosan/zinc citrate toothpastes. Consistent with other studies it appears that stannous fluoride and triclosan can be formulated into toothpaste vehicles to provide plaque inhibitory effects. PMID:9083900

  14. 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. PMID:23982695

  15. 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).

  16. 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

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

    PubMed

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

    2007-12-01

    This double-blind, placebo-controlled, four-way balanced design crossover study included hypertensive patients aged 60-85 years with mean office-measured sitting systolic blood pressure (SBP) 160-179 mm Hg and daytime SBP > or =135 mm Hg. After a 2-week run-in period, during which previous medications were discontinued, each patient received the following four treatments in randomized order for 4 weeks each: lercanidipine 10 mg (L), enalapril 20 mg (E), lercanidipine 10 mg plus enalapril 20 mg (L/E) and placebo (P). At the end of each treatment period, office trough blood pressure (BP) was measured and a 24-h Ambulatory Blood Pressure Monitoring (ABPM) was performed. Seventy-five patients (mean age 66 years, office BP 168/92 mm Hg, daytime SBP 151 mm Hg) were randomized and 62 completed the study with four valid post-baseline ABPMs. The administration of P, L, E and L/E was associated with a mean 24-h SBP of 144, 137, 133 and 127 mm Hg, respectively. All active treatments significantly reduced the mean 24-h SBP in comparison with placebo, but L/E was significantly more effective than L and E alone. Similarly, office SBP was significantly more reduced with L/E (-16.9 mm Hg) than with L (-5.0 mm Hg) or E (-5.9 mm Hg). A BP <140/90 mm Hg was recorded in 18% of patients with L, 19% with E and 45% with L/E. Two patients on P and two on L/E were withdrawn from the study due to adverse events. In conclusion, combination therapy with L/E has additive antihypertensive effects on both ambulatory and office BP in elderly patients and is well tolerated. PMID:17581601

  18. 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

  19. 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

  20. 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

  1. Randomized, double-blind, placebo-controlled, linear dose, crossover study to evaluate the efficacy and safety of a green coffee bean extract in overweight subjects

    PubMed Central

    Vinson, Joe A; Burnham, Bryan R; Nagendran, Mysore V

    2012-01-01

    Background Adult weight gain and obesity have become worldwide problems. Issues of cost and potential side effects of prescription weight loss drugs have led overweight and obese adults to try nutraceuticals that may aid weight loss. One promising nutraceutical is green coffee extract, which contains high concentrations of chlorogenic acids that are known to have health benefits and to influence glucose and fat metabolism. A 22-week crossover study was conducted to examine the efficacy and safety of a commercial green coffee extract product GCA™ at reducing weight and body mass in 16 overweight adults. Methods Subjects received high-dose GCA (1050 mg), low-dose GCA (700 mg), or placebo in separate six-week treatment periods followed by two-week washout periods to reduce any influence of preceding treatment. Treatments were counterbalanced between subjects. Primary measurements were body weight, body mass index, and percent body fat. Heart rate and blood pressure were also measured. Results Significant reductions were observed in body weight (−8.04 ± 2.31 kg), body mass index (−2.92 ± 0.85 kg/m2), and percent body fat (−4.44% ± 2.00%), as well as a small decrease in heart rate (−2.56 ± 2.85 beats per minute), but with no significant changes to diet over the course of the study. Importantly, the decreases occurred when subjects were taking GCA. Body mass index for six subjects shifted from preobesity to the normal weight range (<25.00 kg/m2). Conclusion The results are consistent with human and animal studies and a meta-analysis of the efficacy of green coffee extract in weight loss. The results suggest that GCA may be an effective nutraceutical in reducing weight in preobese adults, and may be an inexpensive means of preventing obesity in overweight adults. PMID:22291473

  2. Effects of hydrolysed casein, intact casein and intact whey protein on energy expenditure and appetite regulation: a randomised, controlled, cross-over study.

    PubMed

    Bendtsen, Line Q; Lorenzen, Janne K; Gomes, Sisse; Liaset, Bjørn; Holst, Jens J; Ritz, Christian; Reitelseder, Søren; Sjödin, Anders; Astrup, Arne

    2014-10-28

    Casein and whey differ in amino acid composition and in the rate of absorption; however, the absorption rate of casein can be increased to mimic that of whey by exogenous hydrolysis. The objective of the present study was to compare the effects of hydrolysed casein (HC), intact casein (IC) and intact whey (IW) on energy expenditure (EE) and appetite regulation, and thereby to investigate the influence of amino acid composition and the rate of absorption. In the present randomised cross-over study, twenty-four overweight and moderately obese young men and women consumed three isoenergetic dietary treatments that varied in protein source. The study was conducted in a respiration chamber, where EE, substrate oxidation and subjective appetite were measured over 24 h at three independent visits. Moreover, blood and urine samples were collected from the participants. The results showed no differences in 24 h and postprandial EE or appetite regulation. However, lipid oxidation, estimated from the respiratory quotient (RQ), was found to be higher after consumption of IW than after consumption of HC during daytime (P= 0·014) as well as during the time after the breakfast meal (P= 0·008) when the food was provided. Likewise, NEFA concentrations were found to be higher after consumption of IW than after consumption of HC and IC (P< 0·01). However, there was no overall difference in the concentration of insulin or glucagon-like peptide 1. In conclusion, dietary treatments when served as high-protein mixed meals induced similar effects on EE and appetite regulation, except for lipid oxidation, where RQ values suggest that it is higher after consumption of IW than after consumption of HC. PMID:25191896

  3. Impact of acute administration of escitalopram on the processing of emotional and neutral images: a randomized crossover fMRI study of healthy women

    PubMed Central

    Outhred, Tim; Das, Pritha; Felmingham, Kim L.; Bryant, Richard A.; Nathan, Pradeep J.; Malhi, Gin S.; Kemp, Andrew H.

    2014-01-01

    Background Acute neural effects of antidepressant medication on emotion processing biases may provide the foundation on which clinical outcomes are based. Along with effects on positive and negative stimuli, acute effects on neutral stimuli may also relate to anti-depressant efficacy, yet these effects are still to be investigated. The present study therefore examined the impact of a single dose of the selective serotonin reuptake inhibitor escitalopram (20 mg) on positive, negative and neutral stimuli using pharmaco-fMRI. Methods Within a double-blind, randomized, placebo-controlled crossover design, healthy women completed 2 sessions of treatment administration and fMRI scanning separated by a 1-week washout period. Results We enrolled 36 women in our study. When participants were administered escitalopram relative to placebo, left amygdala activity was increased and right inferior frontal gyrus (IFG) activity was decreased during presentation of positive pictures (potentiation of positive emotion processing). In contrast, escitalopram was associated with decreased left amygdala and increased right IFG activity during presentation of negative pictures (attenuation of negative emotion processing). In addition, escitalopram decreased right IFG activity during the processing of neutral stimuli, akin to the effects on positive stimuli (decrease in negative appraisal). Limitations Although we used a women-only sample to reduce heterogeneity, our results may not generalize to men. Potential unblinding, which was related to the subjective occurrence of side effects, occurred in the study; however, manipulation check analyses demonstrated that results were not impacted. Conclusion These novel findings demonstrate that a single dose of the commonly prescribed escitalopram facilitates a positive information processing bias. These findings provide an important lead for better understanding effects of antidepressant medication. PMID:24690370

  4. Frovatriptan versus almotriptan for acute treatment of menstrual migraine: analysis of a double-blind, randomized, cross-over, multicenter, Italian, comparative study.

    PubMed

    Bartolini, Marco; Giamberardino, Maria Adelaide; Lisotto, Carlo; Martelletti, Paolo; Moscato, Davide; Panascia, Biagio; Savi, Lidia; Pini, Luigi Alberto; Sances, Grazia; Santoro, Patrizia; Zanchin, Giorgio; Omboni, Stefano; Ferrari, Michel D; Fierro, Brigida; Brighina, Filippo

    2012-07-01

    The objective of the study was to compare the efficacy and safety of frovatriptan and almotriptan in women with menstrually related migraine (IHS Classification of Headache disorders) enrolled in a multicenter, randomized, double-blind, cross-over study. Patients received frovatriptan 2.5 mg or almotriptan 12.5 mg in a randomized sequence: after treating 3 episodes of migraine in no more than 3 months with the first treatment, the patient was switched to the other treatment. 67 of the 96 female patients of the intention-to-treat population of the main study had regular menstrual cycles and were thus included in this subgroup analysis. 77 migraine attacks classified as related to menses were treated with frovatriptan and 78 with almotriptan. Rate of pain relief at 2 and 4 h was 36 and 53 % for frovatriptan and 41 and 50 % for almotriptan (p = NS between treatments). Rate of pain free at 2 and 4 h was 19 and 47 % with frovatriptan and 29 and 54 % for almotriptan (p = NS). At 24 h, 62 % of frovatriptan-treated and 67 % of almotriptan-treated patients had pain relief, while 60 versus 67 % were pain free (p = NS). Recurrence at 24 h was significantly (p < 0.05) lower with frovatriptan (8 vs. 21 % almotriptan). This was the case also at 48 h (9 vs. 24 %, p < 0.05). Frovatriptan was as effective as almotriptan in the immediate treatment of menstrually related migraine attacks. However, it showed a more favorable sustained effect, as shown by a lower rate of migraine recurrence. PMID:22592864

  5. 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…

  6. 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

  7. 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.

  8. Traffic-Related Air Pollution and the Onset of Myocardial Infarction: Disclosing Benzene as a Trigger? A Small-Area Case-Crossover Study

    PubMed Central

    Bard, Denis; Kihal, Wahida; Schillinger, Charles; Fermanian, Christophe; Ségala, Claire; Glorion, Sophie; Arveiler, Dominique; Weber, Christiane

    2014-01-01

    Background and Objectives Exposure to traffic is an established risk factor for the triggering of myocardial infarction (MI). Particulate matter, mainly emitted by diesel vehicles, appears to be the most important stressor. However, the possible influence of benzene from gasoline-fueled cars has not been explored so far. Methods and Results We conducted a case-crossover study from 2,134 MI cases recorded by the local Coronary Heart Disease Registry (2000–2007) in the Strasbourg Metropolitan Area (France). Available individual data were age, gender, previous history of ischemic heart disease and address of residence at the time of the event. Nitrogen dioxide, particles of median aerodynamic diameter <10 µm (PM10), ozone, carbon monoxide and benzene air concentrations were modeled on an hourly basis at the census block level over the study period using the deterministic ADMS-Urban air dispersion model. Model input data were emissions inventories, background pollution measurements, and meteorological data. We have found a positive, statistically significant association between concentrations of benzene and the onset of MI: per cent increase in risk for a 1 µg/m3 increase in benzene concentration in the previous 0, 0–1 and 1 day was 10.4 (95% confidence interval 3–18.2), 10.7 (2.7–19.2) and 7.2 (0.3–14.5), respectively. The associations between the other pollutants and outcome were much lower and in accordance with the literature. Conclusion We have observed that benzene in ambient air is strongly associated with the triggering of MI. This novel finding needs confirmation. If so, this would mean that not only diesel vehicles, the main particulate matter emitters, but also gasoline-fueled cars –main benzene emitters–, should be taken into account for public health action. PMID:24932584

  9. 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

  10. 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. PMID:23680182

  11. Effects of Chili Treatment on Gastrointestinal and Rectal Sensation in Diarrhea-predominant Irritable Bowel Syndrome: A Randomized, Double-blinded, Crossover Study

    PubMed Central

    Aniwan, Satimai; Gonlachanvit, Sutep

    2014-01-01

    Background/Aims Whether, chronic chili ingestion can desensitize transient receptor potential vanilloid type 1 receptors in gastrointestinal (GI) tract leading to decrease GI symptoms and sensation in diarrhea-predominant irritable bowel syndrome (IBS-D) patients has not been well explored. The aim of this study was to determine the effects of 6-week chili treatment on postprandial GI symptoms and rectal sensation in response to balloon distention in IBS-D patients. Methods Sixteen IBS-D patients received placebo or chili capsules before meals 3 times/day for 6 weeks in a randomized, double-blinded, crossover fashion with 4-week washout period. Postprandial GI symptoms were evaluated. All patients underwent a rectal barostat study to evaluate rectal sensory threshold at the end of each treatment. Results The maximum postprandial abdominal burning scores were similar between both treatments at baseline (1.4 [0.0–2.0] vs. 1.1 [0.0–2.8], P > 0.05) but were significantly decreased after chili (0.0 [0.0–0.5] vs. 0.3 [0.0–1.6], P < 0.05) at the end of treatment. The chili treatment significantly increased sensory threshold for the first rectal sensation (median [interquartile range]:16 [12–16] mmHg vs. 8 [8–16] mmHg, P < 0.05) however, there was no significant effect on rectal compliance (7.3 ± 1.0 vs. 7.1 ± 1.8 mL/mmHg). Other postprandial GI symptoms did not vary significantly between both treatments at baseline and the end of treatment. Conclusions In IBS-D patients, 6-week chili ingestion significantly decreased postprandial abdominal burning and increased the rectal sensory threshold. These findings suggest a desensitization effect of chili ingestion on transient receptor potential vanilloid type 1 receptors in the proximal gut and rectum. PMID:24867591

  12. 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

  13. 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. PMID:23702187

  14. Relative bioequivalence evaluation of two oral atomoxetine hydrochloride capsules: a single dose, randomized, open-label, 2-period crossover study in healthy Chinese volunteers under fasting conditions.

    PubMed

    Shang, D-W; Guo, W; Zhou, F-C; Wang, X-P; Li, A-N; Zhang, L; Li, W-B; Lu, W; Wang, C-Y

    2013-11-01

    To evaluate the bioequivalence of a new formulation of atomoxetine hydrochloride (CAS 82248-59-7) capsules (test) and an available branded capsules (reference) after administration of a single 40 mg dose, randomized, open-label, 2-period crossover study was conducted in 22 healthy male Chinese subjects with a 1-week wash-out period. This study was designed for/the Honglin Pharmaceutical Co. Ltd and contracted to be done by the Beijing Anding Hospital in order to satisfy Chinese regulatory requirements to allow marketing of this generic product and performed according to the criteria of SFDA. Blood samples were collected before and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16 and 24 h after drug administration. Plasma concentrations were determined by high-performance liquid chromatography (HPLC) with UV detection. A non-compartmental method was used to calculate the pharmacokinetic parameters and evaluate bioequivalence of the 2 formulations. The 90% confidence interval (CI) of the ratios (test/reference) of atomoxetine for AUC0-24, AUC0-∞ and Cmax were 100.9% (93.6-108.8%), 103.1% (95.1-111.7%) and 105.2% (92.8-119.4%), respectively, which fell within the interval of 80-125% and 75-133%. No clinically significant changes or abnormalities were noted in laboratory data and vital signs. From these results it can be concluded that the test formulation of atomoxetine capsules met the regulatory criterion for bioequivalence to the reference formulation. PMID:23812961

  15. Efficacy of an essential fatty acid-enriched diet in managing canine atopic dermatitis: a randomized, single-blinded, cross-over study.

    PubMed

    Bensignor, Emmanuel; Morgan, David M; Nuttall, Tim

    2008-06-01

    Evidence suggests that high-quality diets enriched with essential fatty acids (EFA) and other nutrients can ameliorate canine atopic dermatitis (AD). This study compared such a diet (Eukanuba Veterinary Diets Dermatosis FP) with a home-cooked equivalent (fish and potato) in a randomised, single-blinded, cross-over trial. Twenty dogs with perennial AD were randomly assigned to receive either the test (group A) or the control diet (group B) for 1 month, followed by the contrasting diet for a further month. Canine Atopic Dermatitis Extent and Severity Index (CADESI version 2) and pruritus (visual analogue scale) scores were recorded at days 0, 30 and 60. Eight dogs in each group completed the study. CADESI scores significantly declined when dogs were fed the test diet (group A P < 0.01; group B P < 0.001), and increased (group A P < 0.05) or remained steady (group B) on the control diet. CADESI scores decreased in 15 of 16 dogs fed the test diet, but this was less than 50% in all cases. Pruritus scores also declined when dogs were fed the test diet compared to the control diet, but this was only significant for group A (P = 0.027). Pruritus was reduced in 11 of 16 dogs fed the test diet, but this was 50% or more in only two dogs. This trial provides evidence for the efficacy of Eukanuba Veterinary Diets Dermatosis FP in canine AD, although it is likely that most cases will require adjunct therapy. The mechanism is unclear, but may involve increased and balanced EFA levels. PMID:18477332

  16. Short-Term Effects of Coarse Particulate Matter on Hospital Admissions for Cardiovascular Diseases: A Case-Crossover Study in a Tropical City.

    PubMed

    Chen, Ying-Chen; Weng, Yi-Hao; Chiu, Ya-Wen; Yang, Chun-Yuh

    2015-01-01

    This study was undertaken to determine whether there was an association between coarse particles (PM2.5-10) levels and frequency of hospital admissions for cardiovascular diseases (CVD) in Kaohsiung, Taiwan. Hospital admissions for CVD, including ischemic heart disease (IHD), stroke, congestive heart failure (CHF), and arrhythmias, and ambient air pollution data levels for Kaohsiung were obtained for the period 2006-2010. The relative risk of hospital admissions for CVD 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 rates of admissions for CVD were significantly associated with higher coarse PM levels only on cool days (< 25°C), with a 10-μg/m(3) elevation in PM2.5-10 concentrations associated with a 3% (95% CI = 2-4%) rise in IHD admissions, 5% (95% CI = 4-6%) increase in stroke admissions, 3% (95% CI = 1-6%) elevation in CHF admissions, and 3% (95% CI = 0-6%) rise in arrhythmias admissions. No significant associations were found between coarse particle levels and number of hospital admissions for CVD on warm days. In the two-pollutant models, PM2.5-10 levels remained significantly correlated with higher rate of CVD admissions even controlling for sulfur dioxide, nitrogen dioxide, carbon monoxide, or ozone on cool days. Compared to the effect estimate associated with a 10-μg/m(3) increase in PM2.5 levels, effect estimates of frequency of CVD-related admissions associated with a 10-μg/m(3) rise in coarse PM levels were weaker. This study provides evidence that higher levels of PM2.5-10 enhance the risk of hospital admissions for CVD. PMID:26408041

  17. 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

  18. 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

  19. Comparison of gadoxetic acid and gadopentetate dimeglumine-enhanced MRI for HCC detection: prospective crossover study at 3 T

    PubMed Central

    Besa, Cecilia; Kakite, Suguru; Cooper, Nancy; Facciuto, Marcelo

    2015-01-01

    Background Gadoxetic acid and gadopentetate dimeglumine are gadolinium-based contrast agents (GBCAs) with an established role in HCC detection and characterization. Purpose To compare gadopentetate dimeglumine and gadoxetic acid-enhanced magnetic resonance imaging (MRI) for image quality and hepatocellular carcinoma (HCC) detection/conspicuity. Material and Methods In this IRB approved cross-over pilot prospective study, 12 patients (all men; mean age, 56 years) with chronic liver disease at risk of HCC underwent two repeat MRI examinations using gadopentetate dimeglumine and gadoxetic acid (mean interval between studies, 5 days). Two independent observers analyzed images for image quality and HCC detection/conspicuity. Per-lesion sensitivity, positive predictive value, quantitative enhancement, and lesion-to-liver contrast ratio were calculated for both contrast agents. Results There was no significant difference in image quality scores between both GBCAs (P = 0.3). A total of 20 HCCs were identified with reference standard in 12 patients (mean size 2.6 cm, range, 1.0–5.0 cm). Higher sensitivity was seen for observer 1 for gadoxetic acid-set in comparison with gadopentetate dimeglumine-set (sensitivity increased from 85.7% to 92.8%), while no difference was noted for observer 2 (sensitivity of 78.5%). Lesion conspicuity was significantly higher on hepatobiliary phase (HBP) images compared to arterial phase images with both GBCAs for both observers (P < 0.05). Lesion-to-liver contrast ratios were significantly higher for HBP compared to all dynamic phases for both agents (P < 0.05). Conclusion Our initial experience suggests that gadoxetic acid-set was superior to gadopentetate dimeglumine-set in terms of HCC detection for one observer, with improved lesion conspicuity and liver-to-lesion contrast on HBP images. PMID:25793110

  20. 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. PMID:26300016

  1. Does trans-spinal direct current stimulation alter phrenic motoneurons and respiratory neuromechanical outputs in humans? A double-blind, sham-controlled, randomized, crossover study.

    PubMed

    Niérat, Marie-Cécile; Similowski, Thomas; Lamy, Jean-Charles

    2014-10-22

    Although compelling evidence has demonstrated considerable neuroplasticity in the respiratory control system, few studies have explored the possibility of altering descending projections to phrenic motoneurons (PMNs) using noninvasive stimulation protocols. The present study was designed to investigate the immediate and long-lasting effects of a single session of transcutaneous spinal direct current stimulation (tsDCS), a promising technique for modulating spinal cord functions, on descending ventilatory commands in healthy humans. Using a double-blind, controlled, randomized, crossover approach, we examined the effects of anodal, cathodal, and sham tsDCS delivered to the C3-C5 level on (1) diaphragm motor-evoked potentials (DiMEPs) elicited by transcranial magnetic stimulation and (2) spontaneous ventilation, as measured by respiratory inductance plethysmography. Both anodal and cathodal tsDCS induced a progressive increase in DiMEP amplitude during stimulation that persisted for at least 15 min after current offset. Interestingly, cathodal, but not anodal, tsDCS induced a persistent increase in tidal volume. In addition, (1) short-interval intracortical inhibition, (2) nonlinear complexity of the tidal volume signal (related to medullary ventilatory command), (3) autonomic function, and (4) compound muscle action potentials evoked by cervical magnetic stimulation were unaffected by tsDCS. This suggests that tsDCS-induced aftereffects did not occur at brainstem or cortical levels and were likely not attributable to direct polarization of cranial nerves or ventral roots. Instead, we argue that tsDCS could induce sustained changes in PMN output. Increased tidal volume after cathodal tsDCS opens up the perspective of harnessing respiratory neuroplasticity as a therapeutic tool for the management of several respiratory disorders. PMID:25339753

  2. Eye Expert Dr. Emily Chew: 3 Ways to Keep Your Sight

    MedlinePlus

    ... Issues Feature: Vision Eye Expert Dr. Emily Chew: 3 Ways to Keep Your Sight Past Issues / Summer ... a healthy diet. New research shows that omega-3 fatty acids may protect the retina from wear. ...

  3. 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

  4. 3-way Networks: Application of Hypergraphs for Modelling Increased Complexity in Comparative Genomics

    SciTech Connect

    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.

  5. 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

  6. 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

  7. Effects of chocolate milk consumption on markers of muscle recovery following soccer training: a randomized cross-over study

    PubMed Central

    2010-01-01

    Background The efficacy of chocolate milk (CM) as a recovery beverage following a period of increased training duration (ITD) was studied in intercollegiate soccer players. Methods 13 subjects completed one week of normal 'baseline' training followed by four days of ITD. After each day of ITD, subjects received either a high-carbohydrate (504 kcal; CHO: 122 g; 2 g Fat) or isocaloric CM (504 kcal; 84 g CHO; 28 g Pro; 7 g Fat) recovery beverage. Serum creatine kinase (CK), myoglobin (Mb), muscle soreness, fatigue ratings and isometric quadriceps force (MVC) were obtained prior to ITD, and following 2- and 4-days of ITD. Performance tests (T-drill, vertical jump) were performed within training sessions. Treatments were administered in a randomly counterbalanced protocol, and subjects repeated the procedures with the alternate beverage following a two-week washout period. Results Mean daily training time and HR increased (p < 0.05) between baseline training and ITD, with no differences between treatments. No treatment*time effects were observed for Mb, muscle soreness, fatigue ratings and MVC. However, serum CK was significantly lower (p < 0.05) following four days of ITD with CM (316.9 ± 188.3 U·L-1) compared to CHO (431.6 ± 310.8 U·L-1). No treatment differences were observed for the performance tests. Conclusions Post-exercise CM provided similar muscle recovery responses to an isocaloric CHO beverage during four-days of ITD. Future studies should investigate if the attenuated CK levels observed with CM have functional significance during more demanding periods of training. PMID:20482784

  8. 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])

  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. 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.

  11. Prooxidant/Antioxidant Balance in Hypoxia: A Cross-Over Study on Normobaric vs. Hypobaric “Live High-Train Low”

    PubMed Central

    Debevec, Tadej; Pialoux, Vincent; Saugy, Jonas; Schmitt, Laurent; Cejuela, Roberto; Mury, Pauline; Ehrström, Sabine; Faiss, Raphael; Millet, Grégoire P.

    2015-01-01

    “Live High-Train Low” (LHTL) training can alter oxidative status of athletes. This study compared prooxidant/antioxidant balance responses following two LHTL protocols of the same duration and at the same living altitude of 2250 m in either normobaric (NH) or hypobaric (HH) hypoxia. Twenty-four well-trained triathletes underwent the following two 18-day LHTL protocols in a cross-over and randomized manner: Living altitude (PIO2 = 111.9 ± 0.6 vs. 111.6 ± 0.6 mmHg in NH and HH, respectively); training “natural” altitude (~1000–1100 m) and training loads were precisely matched between both LHTL protocols. Plasma levels of oxidative stress [advanced oxidation protein products (AOPP) and nitrotyrosine] and antioxidant markers [ferric-reducing antioxidant power (FRAP), superoxide dismutase (SOD) and catalase], NO metabolism end-products (NOx) and uric acid (UA) were determined before (Pre) and after (Post) the LHTL. Cumulative hypoxic exposure was lower during the NH (229 ± 6 hrs.) compared to the HH (310 ± 4 hrs.; P<0.01) protocol. Following the LHTL, the concentration of AOPP decreased (-27%; P<0.01) and nitrotyrosine increased (+67%; P<0.05) in HH only. FRAP was decreased (-27%; P<0.05) after the NH while was SOD and UA were only increased following the HH (SOD: +54%; P<0.01 and UA: +15%; P<0.01). Catalase activity was increased in the NH only (+20%; P<0.05). These data suggest that 18-days of LHTL performed in either NH or HH differentially affect oxidative status of athletes. Higher oxidative stress levels following the HH LHTL might be explained by the higher overall hypoxic dose and different physiological responses between the NH and HH. PMID:26368280

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

    PubMed Central

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

    2016-01-01

    Objective In this work, we aim at comparing formally three different interaction modes for image manipulation that are usable in a surgery setting: 1) A gesture-controlled approach using Kinect ®; 2) oral instructions to a third part dedicated to manipulate the images; and 3) direct manipulation using a mouse. Materials and Methods Each participant used the radiology image viewer Weasis with the three interaction modes. In a crossover randomized controlled trial participants were attributed block wise to six experimental groups. For each group, the order for testing the three modes was randomly assigned. Nine standardized scenarios were used. Results 30 physicians and senior medical students participated in the experiment. Efficiency, measured as time used to pass the scenario, was best when using the mouse (M = 109.10s, SD = 25.96), followed by gesture-controlled (M = 214.97s, SD = 46.29) and oral instructions (M = 246.33s, SD = 76.50). Satisfaction, measured by a questionnaire, was rated highest in the condition mouse (M = 6.63, SD = 0.56), followed by gesture-controlled (M = 5.77, SD = 0.93) and oral instructions (M = 4.40, SD = 1.71). Differences in efficiency and satisfaction rating were significant. No significant difference in effectiveness, measured with error rates, was found. Discussion The study shows with formal evaluation that the use of gestures is advantageous over instructions to a third person. In particular, the use of gestures is more efficient than verbalizing instructions. The given gestures could be learned easily and reliability of the tested gesture-control system is good. Conclusion Under the premise that mouse cannot be used directly during surgery, gesture-controlled approaches demonstrate to be superior to oral instructions for image manipulation. PMID:27082758

  13. 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

  14. 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

  15. 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(®). PMID:25926736

  16. 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

  17. Prevention of head louse infestation: a randomised, double-blind, cross-over study of a novel concept product, 1% 1,2-octanediol spray versus placebo

    PubMed Central

    Burgess, Ian F; Brunton, Elizabeth R; French, Rebecca; Burgess, Nazma A

    2014-01-01

    Objectives To determine whether regular use of a spray containing 1,2-octanediol 1%, which has been shown to inhibit survival of head lice, is able to work as a preventive against establishment of new infestations. Setting Randomised, double-blind, cross-over, community study in Cambridgeshire, UK. Participants 63 male and female schoolchildren aged 4–16 years judged to have a high risk of recurrent infestation. Only the youngest member of a household attending school participated. Interventions Participants were treated to eliminate lice, randomised between 1% octanediol or placebo sprays for 6 weeks then crossed-over to the other spray for 6 weeks. Parents applied the sprays at least twice weekly or more frequently if the hair was washed. Investigators monitored weekly for infestation and replenished supplies of spray. Primary and secondary outcome measures The primary endpoint was the time taken until the first infestation event occurred. The secondary measure was safety of the product in regular use. Results Intention-to-treat analysis found a total of 32 confirmed infestations in 20 participants, with 9 of them infested while using both products. In these nine participants the time to first infestation showed a significant advantage to 1% octanediol (p=0.0129). Per-protocol analysis showed only trends because the population included was not large enough to demonstrate significance. There were no serious adverse events and only two adverse events possibly related to treatment, one was a case of transient erythema and another of a rash that resolved after 5 days. Conclusions Routine use of 1% octanediol spray provided a significant level of protection from infestation. It was concluded that this product is effective if applied regularly and thoroughly. Trial registration number ISRCTN09524995. PMID:24879825

  18. Comparative Effectiveness of 3-Dimensional vs 2-Dimensional and High-Definition vs Standard-Definition Neuroendoscopy: A Preclinical Randomized Crossover Study

    PubMed Central

    Hughes-Hallett, Archie; Cundy, Thomas P.; Di Marco, Aimee; Pratt, Philip; Nandi, Dipankar; Darzi, Ara; Yang, Guang-Zhong

    2013-01-01

    BACKGROUND: Although the potential benefits of 3-dimensional (3-D) vs 2-dimensional (2-D) and high-definition (HD) vs standard-definition (SD) endoscopic visualization have long been recognized in other surgical fields, such endoscopes are generally considered too large and bulky for use within the brain. The recent development of 3-D and HD neuroendoscopes may therefore herald improved depth perception, better appreciation of anatomic details, and improved overall surgical performance. OBJECTIVE: To compare simultaneously the effectiveness of 3-D vs 2-D and HD vs SD neuroendoscopy. METHODS: Ten novice neuroendoscopic surgeons were recruited from a university hospital. A preclinical randomized crossover study design was adopted to compare 3-D vs 2-D and HD vs SD neuroendoscopy. The primary outcomes were time to task completion and accuracy. The secondary outcomes were perceived task workload using the NASA (National Aeronautics and Space Administration) Task Load Index and subjective impressions of the endoscopes using a 5-point Likert scale. RESULTS: Time to task completion was significantly shorter when using the 3-D vs the 2-D neuroendoscopy (P = .001), and accuracy of probe placement was significantly greater when using the HD vs the SD neuroendoscopy (P = .009). We found that 3-D endoscopy significantly improved perceived depth perception (P < .001), HD endoscopy significantly improved perceived image quality (P < .001), and both improved participants’ overall impression (P < .001). CONCLUSION: Three-dimensional neuroendoscopy and HD neuroendoscopy have differing but complementary effects on surgical performance, suggesting that neither alone can completely compensate for the lack of the other. There is therefore strong preclinical evidence to justify 3-D HD neuroendoscopy. ABBREVIATIONS: HD, high definition SD, standard definition PMID:24220007

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

    PubMed Central

    Emami, Mohammad Hossein; Talaei, Mohammad; Panahi, Yunes; Saburi, Amin; Ghanei, Mostafa

    2014-01-01

    Background: Gastro-esophageal reflux disease (GERD) is prevalent and related to more severe disease in patients with respiratory problems. We evaluated the effects of antireflux therapy in warfare victims of exposure to Mustard gas with chronic cough. Materials and Methods: This randomized, double-blind, placebo-controlled, cross-over study was conducted on 45 cases of sulfur mustard injury with chronic cough (≥8 weeks) and GERD. Patients were randomized into two groups, receiving either 20 mg twice daily omeprazole-placebo (OP) or matching placebo (placebo-omeprazole [PO]) for 4 months, followed by a 1-month washout period and the alternative treatment for 4 months. Assessments included GERD and cough, quality of life, and pulmonary function using spirometry. Leicester Cough Questionnaire and SF-36 were used for measuring quality of life. Results: Patients in the OP group experienced a more decrease than those in the PO group in severity of Leicester cough scores during the first 4-month of trial. After crossing the groups, the OP group experienced an increase (P = 0.036) and the PO group experienced a nonsignificant decrease (P = 0.104) in the severity of scores. The OP group also experienced improvement in GERD symptoms and quality of life at the end of the trial, but changes in the PO group was not significant. There was no significant change in respiratory function indices in any groups. Conclusion: Long-term treatment with high-dose omeprazole improved GERD as well as cough, and quality of life, but not changed respiratory function indices in sulfur mustard injured cases with respiratory symptoms. PMID:25657745

  20. 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

  1. 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. PMID:26192629

  2. 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

  3. Efficacy of Moringa oleifera leaf powder as a hand- washing product: a crossover controlled study among healthy volunteers

    PubMed Central

    2014-01-01

    Background Moringa oleifera is a plant found in many tropical and subtropical countries. Many different uses and properties have been attributed to this plant, mainly as a nutritional supplement and as a water purifier. Its antibacterial activity against different pathogens has been described in different in vitro settings. However the potential effect of this plant leaf as a hand washing product has never been studied. The aim of this study is to test the efficacy of this product using an in vivo design with healthy volunteers. Methods The hands of fifteen volunteers were artificially contaminated with Escherichia coli. Moringa oleifera leaf powder was tested as a hand washing product and was compared with reference non-medicated liquid soap using a cross over design following an adaptation of the European Committee for Standardization protocol (EN 1499). In a second part of tests, the efficacy of the established amount of Moringa oleifera leaf powder was compared with an inert powder using the same protocol. Results Application of 2 and 3 g of dried Moringa oleifera leaf powder (mean log10-reduction: 2.44 ± 0.41 and 2.58 ± 0.34, respectively) was significantly less effective than the reference soap (3.00 ± 0.27 and 2.99 ± 0.26, respectively; p < 0.001). Application of the same amounts of Moringa oleifera (2 and 3 g) but using a wet preparation, was also significantly less effective than reference soap (p < 0.003 and p < 0.02, respectively). However there was no significant difference when using 4 g of Moringa oleifera powder in dried or wet preparation (mean log10-reduction: 2.70 ± 0.27 and 2.91 ± 0.11, respectively) compared with reference soap (2.97 ± 0.28). Application of calcium sulphate inert powder was significantly less effective than the 4 g of Moringa oleifera powder (p < 0.01). Conclusion Four grams of Moringa oleifera powder in dried and wet application had the same effect as non-medicated soap

  4. 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

  5. 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

    2015-02-01

    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

  6. 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

  7. 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

  8. THE SUBJECTIVE PSYCHOACTIVE EFFECTS OF ORAL DRONABINOL STUDIED IN A RANDOMIZED, CONTROLLED CROSSOVER CLINICAL TRIAL FOR PAIN

    PubMed Central

    Issa, Mohammed A.; Narang, Sanjeet; Jamison, Robert N.; Michna, Edward; Edwards, Robert R.; Penetar, David M.; Wasan, Ajay D.

    2014-01-01

    Background Many cannabinoid medications are approved in North America or in Phase III trials, such as Dronabinol, Nabilone, or Nabiximols. Little is known about their subjective psychoactive effects when used for pain management. We hypothesized that when used for pain, dronabinol has psychoactive effects in a dose response relationship, whose peak effects are comparable to smoking marijuana. Methods With IRB approval and written consent, this was a randomized controlled trial of single dose placebo, 10 or 20 mg dronabinol in 30 chronic non-cancer pain patients taking opioids and not using marijuana. Hourly, for 8 hours during 3 monitored sessions, subjects completed the Addiction Research Center Inventory (ARCI). Comparison sample was the ARCI ratings in a study population with no pain (N=20), monitored every 30 minutes after smoking a 1.99% THC (low) and a 3.51% (high strength) marijuana cigarette. Results The 10 and 20 mg dronabinol doses had significantly elevated scores on 4/5 subscales vs. placebo over time (p<.05). Average daily morphine use, total pain relief (TOTPAR), age, gender, and baseline pain level were not significant covariates. ARCI peak effects at 2 hours were similar to peak effects of smoked marijuana at 30 minutes (p=.80, 10 mg=low, 20 mg=high strength). Conclusions In pain patients, oral dronabinol has similar psychoactive effects to smoking marijuana. This risk must be considered in any decision to prescribe cannabinoid medications for pain. PMID:24281276

  9. 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

  10. 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.

  11. 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.

  12. Microelectronic superconducting crossover and coil

    DOEpatents

    Wellstood, Frederick C.; Kingston, John J.; Clarke, John

    1994-01-01

    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. 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.

  14. Characterization of acute ischemia‐related physiological responses associated with remote ischemic preconditioning: a randomized controlled, crossover human study

    PubMed Central

    Sharma, Vikram; Cunniffe, Brian; Verma, Amit P.; Cardinale, Marco; Yellon, Derek

    2014-01-01

    Abstract Remote Ischemic Preconditioning (RIPC) is emerging as a new noninvasive intervention that has the potential to protect a number of organs against ischemia–reperfusion (IR) injury. The standard protocols normally used to deliver RIPC involve a number of cycles of inflation of a blood pressure (BP) cuff on the arm and/or leg to an inflation pressure of 200 mmHg followed by cuff deflation for a short period of time. There is little evidence to support what limb (upper or lower) or cuff inflation pressures are most effective to deliver this intervention without causing undue discomfort/pain in nonanesthetized humans. In this preliminary study, a dose–response assessment was performed using a range of cuff inflation pressures (140, 160, and 180 mmHg) to induce limb ischemia in upper and lower limbs. Physiological changes in the occluded limb and any pain/discomfort associated with RIPC with each cuff inflation pressure were determined. Results showed that ischemia can be induced in the upper limb at much lower cuff inflation pressures compared with the standard 200 mmHg pressure generally used for RIPC, provided the cuff inflation pressure is ~30 mmHg higher than the resting systolic BP. In the lower limb, a higher inflation pressure, (~55 mmHg > resting systolic BP), is required to induce ischemia. Cyclical changes in capillary blood O2, CO2, and lactate levels during the RIPC stimulus were observed. RIPC at higher cuff inflation pressures of 160 and 180 mmHg was better tolerated in the upper limb. In summary, limb ischemia for RIPC can be more easily induced at lower pressures and is much better tolerated in the upper limb in young healthy individuals. However, whether benefits of RIPC can also be derived with protocols delivered to the upper limb using lower cuff inflation pressures and with lesser discomfort compared to the lower limb, remains to be investigated. PMID:25413320

  15. 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

  16. Post-Exercise Hypotension and Its Mechanisms Differ after Morning and Evening Exercise: A Randomized Crossover Study

    PubMed Central

    da Silva Junior, Natan D.; Tinucci, Tais; Casarini, Dulce E.; Cipolla-Neto, José

    2015-01-01

    Post-exercise hypotension (PEH), calculated by the difference between post and pre-exercise values, it is greater after exercise performed in the evening than the morning. However, the hypotensive effect of morning exercise may be masked by the morning circadian increase in blood pressure. This study investigated PEH and its hemodynamic and autonomic mechanisms after sessions of aerobic exercise performed in the morning and evening, controlling for responses observed after control sessions performed at the same times of day. Sixteen pre-hypertensive men underwent four sessions (random order): two conducted in the morning (7:30am) and two in the evening (5pm). At each time of day, subjects underwent an exercise (cycling, 45 min, 50%VO2peak) and a control (sitting rest) session. Measurements were taken pre- and post-interventions in all the sessions. The net effects of exercise were calculated for each time of day by [(post-pre exercise)-(post-pre control)] and were compared by paired t-test (P<0.05). Exercise hypotensive net effects (e.g., decreasing systolic, diastolic and mean blood pressure) occurred at both times of day, but systolic blood pressure reductions were greater after morning exercise (-7±3 vs. -3±4 mmHg, P<0.05). Exercise decreased cardiac output only in the morning (-460±771 ml/min, P<0.05), while it decreased stroke volume similarly at both times of day and increased heart rate less in the morning than in the evening (+7±5 vs. +10±5 bpm, P<0.05). Only evening exercise increased sympathovagal balance (+1.5±1.6, P<0.05) and calf blood flow responses to reactive hyperemia (+120±179 vs. -70±188 U, P<0.05). In conclusion, PEH occurs after exercise conducted at both times of day, but the systolic hypotensive effect is greater after morning exercise when circadian variations are considered. This greater effect is accompanied by a reduction of cardiac output due to a smaller increase in heart rate and cardiac sympathovagal balance. PMID:26186444

  17. Gender and triptan efficacy: a pooled analysis of three double-blind, randomized, crossover, multicenter, Italian studies comparing frovatriptan vs. other triptans.

    PubMed

    Franconi, Flavia; Finocchi, Cinzia; Allais, Gianni; Omboni, Stefano; Tullo, Vincenzo; Campesi, Ilaria; Reggiardo, Giorgio; Benedetto, Chiara; Bussone, Gennaro

    2014-05-01

    Migraine is three times as common in females as in males, and attacks may be more severe and difficult to treat in women. However, no study specifically addressed possible gender differences in response to antimigraine therapy. The objective of this study was to review the efficacy of frovatriptan vs. other triptans, in the acute treatment of migraine in subgroups of subjects classified according to gender (men vs. women) through a pooled analysis of three individual randomized Italian studies. 414 patients suffering from migraine with or without aura were randomized to frovatriptan 2.5 mg or rizatriptan 10 mg (study 1), frovatriptan 2.5 mg or zolmitriptan 2.5 mg (study 2), frovatriptan 2.5 mg or almotriptan 12.5 mg (study 3). All studies had a multicenter, randomized, double-blind, crossover design. After treating 1-3 episodes of migraine in no more than 3 months with the first treatment, patients switched to the other treatment for the next 3 months. In this analysis, traditional migraine endpoints were compared between the 66 men and 280 women of the intent-to-treat population. At baseline, long-term and debilitating migraine attacks were more frequently reported by women than men. During the observation period, the proportion of pain-free attacks at 2 h did not significantly differ between frovatriptan and the comparators in either men (32 vs. 38 %, p = NS) or women (30 vs. 33 %, p = NS). Pain relief was also similar between treatments for both genders (men: 56 % frovatriptan vs. 57 % comparators; women: 55 vs. 57 %; p = NS for both). The rate of relapse was significantly lower with frovatriptan than with the comparators in men (24 h: 10 vs. 30 %; 48 h: 21 vs. 39 %; p < 0.05) as well as in women (24 h: 14 vs. 23 %; 48 h: 28 vs. 40 %; p < 0.05). The rate of adverse drug reactions was significantly larger with comparators, irrespectively of gender. Although migraine presents in a more severe form in women, frovatriptan seems to retain its good efficacy and

  18. Chronic and acute effects of walnuts on antioxidant capacity and nutritional status in humans: a randomized, cross-over pilot study

    PubMed Central

    2010-01-01

    Background Compared with other common plant foods, walnuts (Juglans regia) are consistently ranked among the highest in antioxidant capacity. In vitro, walnut polyphenols inhibit plasma and LDL oxidation, while in animal models they lower biomarkers of oxidative stress and raise antioxidant capacity. A limited number of human feeding trials indicate that walnuts improve some measures of antioxidant status, but not others. Methods A 19 wk, randomized crossover trial was conducted in 21 generally healthy men and postmenopausal women ≥50 y to study the dose-response effects of walnut intake on biomarkers of antioxidant activity, oxidative stress, and nutrient status. Subjects were randomized to receive either 21 or 42 g raw walnuts/d during each 6 wk intervention phase with a 6 wk washout between phases. Subjects were instructed to consume their usual diet, but refrain from eating any other tree nuts, seeds, peanuts, or ellagitannin-rich foods during the entire study, and other polyphenol-rich foods for 2 d prior to each study visit. Results Compared to baseline levels, red blood cell (RBC) linoleic acid and plasma pyridoxal phosphate (PLP) were significantly higher after 6 wk with 42 g/d walnuts (P < 0.05 for both). Overall, changes in plasma total thiols, and other antioxidant biomarkers, were not significant with either walnut dose. However, when compared to fasting levels, plasma total thiols were elevated within 1 h of walnut consumption with both doses during the baseline and end visits for each intervention phase (P < 0.05 for all). Despite the observed increase in RBC linoleic and linolenic acids associated with walnut consumption, this substrate for lipid peroxidation only minimally affected malondialdehyde (MDA) and antioxidant capacity. The proportional changes in MDA and Oxygen Radical Absorbance Capacity (ORAC) were consistent with a dose-response effect, although no significant within- or between-group differences were observed for these measures

  19. 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

  20. Bioequivalence evaluation of two capsule formulations of amoxicillin in healthy adult male bangladeshi volunteers: A single-dose, randomized, open-label, two-period crossover study

    PubMed Central

    Ullah, Ashik; Azad, Mohammad Abul Kalam; Sultana, Rebeka; Akbor, Maruf Mohammad; Hasan, Ahasanul; Latif, Mahbub; Hasnat, Abul

    2008-01-01

    Background: Amoxicillin, a semisynthetic penicillin antibiotic, is widely prescribed in Bangladesh due to its extended spectrum and its rapid and extensive oral absorption with good tolerability. Although a number of generic oral formulations of amoxicillin are available in Bangladesh, a study of the bioequivalence and pharmacokinetic properties of these formulations has not yet been conducted in a Bangladeshi population. Objective: The aim of this study was to assess the pharmacokinetic properties and bioequivalence of 2 formulations of amoxicillin 500-mg capsules (test, SK-mox®; reference, Amoxil-Bencard®) using serum data. Methods: This single-dose, randomized, open-label, 2-period crossover study was conducted in healthy male subjects in compliance with the Declaration of Helsinki and International Conference on Harmonisation guidelines. Subjects were assigned to receive the test or the reference drug as a single-dose, 500-mg capsule under fasting conditions after a 1-week washout period. After oral administration, blood samples were collected and analyzed for amoxicillin concentration using a validated high-performance liquid chromatography method. The pharmacokinetic parameters were determined using a noncompartmental method. The formulations were considered bioequivalent if the natural log-transformed ratios of pharmacokinetic parameters were within the predetermined equivalence range of 80% to 125%, according to the US Food and Drug Administration (FDA) requirement. Results: Twenty-four healthy adult male Bangladeshi volunteers (mean [SD] age, 26.92 [3.37] years; age range, 23–34 years; mean [SD] body mass index, 23.O9 [1.58] kg/m2) participated in the study. Using serum data, the values obtained for the test and reference formulations, respectively, were as follows: Cmax, 9.85 (2.73) and 10.63 (2.12) μg/mL; Tmax, 1.29 (0.58) and 1.33 (0.49) hours; and AUC0–12, 27.09 (7.62) and 28.56 (6.30) μg/mL · h−1. No period, sequence, or formulation effects

  1. 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

  2. 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

  3. Hourly differences in air pollution and risk of respiratory disease in the elderly: a time-stratified case-crossover study

    PubMed Central

    2014-01-01

    Background Epidemiological studies have shown adverse effects of short-term exposure to air pollution on respiratory disease outcomes; however, few studies examined this association on an hourly time scale. We evaluated the associations between hourly changes in air pollution and the risk of respiratory disease in the elderly, using the time of the emergency call as the disease onset for each case. Methods We used a time-stratified case-crossover design. Study participants were 6,925 residents of the city of Okayama, Japan, aged 65 or above who were taken to hospital emergency rooms between January 2006 and December 2010 for onset of respiratory disease. We calculated city-representative hourly average concentrations of air pollutants from several monitoring stations. By using conditional logistic regression models, we estimated odds ratios per interquartile-range increase in each pollutant by exposure period prior to emergency call, adjusting for hourly ambient temperature, hourly relative humidity, and weekly numbers of reported influenza cases aged ≥60. Results Suspended particulate matter (SPM) exposure 24 to <72 hours prior to the onset and ozone exposure 48 to <96 hours prior to the onset were associated with the increased risk of respiratory disease. For example, following one interquartile-range increase, odds ratios were 1.05 (95% confidence interval: 1.01, 1.09) for SPM exposure 24 to <48 hours prior to the onset and 1.13 (95% confidence interval: 1.04, 1.23) for ozone exposure 72 to <96 hours prior to the onset. Sulfur dioxide (SO2) exposure 0 to <24 hours prior to onset was associated with the increased risk of pneumonia and influenza: odds ratio was 1.07 per one interquartile-range increase (95% confidence interval: 1.00, 1.14). Elevated risk for pneumonia and influenza of SO2 was observed at shorter lags (i.e., 8–18 hours) than the elevated risks for respiratory disease of SPM or ozone. Overall, the effect estimates for chronic obstructive

  4. 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

  5. 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

  6. 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

  7. Effect of Extended-Release Dexmethylphenidate and Mixed Amphetamine Salts on Sleep: A Double-Blind, Randomized, Crossover Study in Youth with Attention-Deficit Hyperactivity Disorder

    PubMed Central

    Santisteban, J. A.; Stein, M. A.; Bergmame, L.; Gruber, R.

    2015-01-01

    Objective We sought to determine the dose-response effects of extended-release (ER) dexmethylphenidate (d-MPH) and ER mixed amphetamine salts (MAS) on objective measures of sleep. Methods This was an 8-week, double-blind, placebo-controlled, randomized, two period, crossover study of youth with attention-deficit hyperactivity disorder (ADHD) as confirmed by the Kiddie Schedule for Affective Disorders for School-Age Children–Present and Lifetime version (K-SADS-PL). Children aged 10–17 years were recruited from clinical practice, colleague referrals, and flyers. Participants were randomized to initially receive either d-MPH or MAS. During each 4-week drug period, children received three dose levels (10, 20, and 25/30 mg) in ascending order, with placebo substituted for active medication in a randomized fashion during 1 week of the study. After 4 weeks, participants were switched to the alternative medication for another 4 weeks of treatment. The main outcome measure was sleep duration as measured by actigraphy. Children, parents, and researchers were blinded to drug, dose, and placebo status. Results Sixty-five participants met the inclusion criteria and were enrolled in the study. Of these, 37 participants with sufficient sleep data for analysis were included. Sleep schedule measures showed a significant effect for dose on sleep start time (F(1,36) = 6.284; p < 0.05), with a significantly later sleep start time when children were receiving 20- or 30-mg doses, compared with placebo (p < 0.05). A significant dose effect was found on actual sleep duration (F(1,36) = 8.112; p < 0.05), with significantly shorter actual sleep duration for subjects receiving 30 mg compared with those receiving placebo (p < 0.05). There were no significant differences on sleep duration or sleep schedule between the two stimulant medications. The trial is complete and closed to follow-up. Conclusions Higher stimulant doses were associated with reduced sleep duration and later sleep

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. Fine-Scale Crossover Rate Variation on the Caenorhabditis elegans X Chromosome.

    PubMed

    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

  14. 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

  15. 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

  16. 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

  17. Ranolazine versus placebo in patients with ischemic cardiomyopathy and persistent chest pain or dyspnea despite optimal medical and revascularization therapy: randomized, double-blind crossover pilot study

    PubMed Central

    Shammas, Nicolas W; Shammas, Gail A; Keyes, Kathleen; Duske, Shawna; Kelly, Ryan; Jerin, Michael

    2015-01-01

    Background Patients with ischemic cardiomyopathy (ICM) may continue to experience persistent chest pain and/or dyspnea despite pharmacologic therapy and revascularization. We hypothesized that ranolazine would reduce anginal symptoms or dyspnea in optimally treated ICM patients. Methods In this randomized, double-blind, crossover-design pilot study, 28 patients with ICM (ejection fraction less or equal 40%) were included after providing informed consent. A total of 24 patients completed both placebo and ranolazine treatments and were analyzed. All patients were on treatment with a beta blocker, an angiotensin-converting enzyme inhibitor (or angiotensin receptor blocker), and at least one additional antianginal drug. After randomization, patients received up to 1,000 mg ranolazine orally twice a day, as tolerated, versus placebo. The primary end point was change in angina as assessed by the Seattle Angina Questionnaire (SAQ), or in dyspnea as assessed by the Rose Dyspnea Scale (RDS). Change in the RDS and SAQ score from baseline was compared, for ranolazine and placebo, using the Wilcoxon signed rank test or paired t-test. Results Patients had the following demographic and clinical variables: mean age of 71.5 years; male (82.1%); prior coronary bypass surgery (67.9%); prior coronary percutaneous intervention (85.7%); prior myocardial infarction (82.1%); diabetes (67.9%); and mean ejection fraction of 33.1%. No statistical difference was seen between baseline RDS score and that after placebo or ranolazine (n=20) (P≥0.05). There was however, an improvement in anginal frequency (8/10 patients) (P=0.058), quality of life (8/10 patients) (P=0.048), and mean score of all components of the SAQ questionnaire (n=10) (P=0.047) with ranolazine compared with placebo. Conclusion In optimally treated ICM patients with continued chest pain or dyspnea, ranolazine possibly had a positive impact on quality of life, a reduction in anginal frequency, and an overall improvement in the

  18. 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

  19. [Case-crossover design: Basic essentials and applications].

    PubMed

    Carracedo-Martínez, Eduardo; Tobías, Aurelio; Saez, Marc; Taracido, Margarita; Figueiras, Adolfo

    2009-01-01

    Case-crossover analysis is an observational epidemiological design that was proposed by Maclure in 1991 to assess whether a given intermittent or unusual exposure may have triggered an immediate short-term, acute event. The present article outlines the basics of case-crossover designs, as well as their applications and limitations. The case-crossover design is based on exclusively selecting case subjects. To calculate relative risk, exposure during the period of time prior to the event (case period) is compared against the same subject's exposure during one or more control periods. This method is only appropriate when the exposures are transient in time and have acute short-term effects. For exposures in which there is no trend, a unidirectional approach is the most frequent and consists of selecting one or more control periods prior to the case period. When the exposure displays a time trend (e.g., air pollution), a unidirectional approach will yield biased estimates, and therefore bidirectional case-crossover designs are used, which select control time intervals preceding and subsequent to that of the event. The case-crossover design is being increasingly used across a wide range of fields, including factors triggering traffic, occupational and domestic accidents and acute myocardial infarction, and those involved in air pollution and health and pharmacoepidemiology, among others. Insofar as data-analysis is concerned, case-crossover designs can generally be regarded as matched case-control studies and consequently conditional logistic regression can be applied. Lastly, this study analyzes practical examples of distinct applications of the case-crossover design. PMID:19303669

  20. Crossover of marital dissatisfaction during military downsizing among Russian army officers and their spouses.

    PubMed

    Westman, Mina; Vinokur, Amiram D; Hamilton, V Lee; Roziner, Ilan

    2004-10-01

    This study examined mechanisms of strain crossover within couples and the moderating role of gender. Data were collected at a time of military downsizing from a sample of 1,250 Russian army officers and their spouses. The authors tested a model that incorporated 3 mechanisms for the crossover of marital dissatisfaction among dual-earner couples. The model provided support for 2 suggested crossover mechanisms: direct reactions of crossover and indirect mediated effects through social undermining. Strong evidence was also provided for gender asymmetry in the crossover process. Marital dissatisfaction crossed over from husbands to wives but not vice versa, and social undermining behavior played a role in the process of crossover of marital dissatisfaction for husbands but not for wives. PMID:15506859

  1. 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

  2. DMDS or the 3-way: which is more effective in Georgia?

    Technology Transfer Automated Retrieval System (TEKTRAN)

    During 2007 and 2008, Methyl Bromide alternatives were used on nearly 25 and 50% of Georgia’s fumigated plasticulture area, respectively. The primary alternative is the 3-Way (Telone II, chloropicrin, and metam). Dimethyl disulfide (DMDS) is nearing registration, providing a new alternative. All pro...

  3. An open-label, single-dose, crossover study of the pharmacokinetics and metabolism of two oral formulations of 1-octanol in patients with essential tremor.

    PubMed

    Nahab, Fatta B; Wittevrongel, Loretta; Ippolito, Dominic; Toro, Camilo; Grimes, George J; Starling, Judith; Potti, Gopal; Haubenberger, Dietrich; Bowen, Daniel; Buchwald, Peter; Dong, Chuanhui; Kalowitz, Daniel; Hallett, Mark

    2011-10-01

    Existing therapeutic options for management of essential tremor are frequently limited by poor efficacy and adverse effects. Likely the most potent tremor suppressant used is ethanol, although its use is prohibitive due to a brief therapeutic window, and the obvious implications of excessive alcohol use. Longer-chain alcohols have been shown to suppress tremor in harmaline animal models, and appear to be safe and well tolerated in 2 prior studies in humans. Here we report on the findings of a phase I/II study of 1-octanol designed to explore pharmacokinetics, efficacy, and safety. The most significant finding was the identification of octanoic acid as the product of rapid 1-octanol metabolism. Furthermore, the temporal profile of efficacy closely matches the plasma concentration of octanoic acid. Therefore, these findings identify a novel class of compound (e.g., carboxylic acids) with tremor suppressive properties in ET. Administration of 1-octanol also appears to be safe based on various measures collected. Essential tremor (ET) is the most common tremor disorder, with tremors occurring during static posturing or movement. These tremors are known to briefly improve in many cases after alcohol (ethanol) consumption. Two previous studies of a longer chain alcohol, 1-octanol, have demonstrated longer duration tremor-suppressive effects without the occurrence of intoxication. The aim of this study was to characterize the pharmacokinetics of 1-octanol and its primary metabolite octanoic acid using two formulations, along with additional safety and efficacy measures. Participants with proven ethanol-responsive ET were recruited into 1 of 2 parts: (part A) a dose escalation study (1-64 mg/kg; n = 4), and (part B) a fixed dose (64 mg/kg; n = 10) balanced, open-label crossover design. Two participants in part B then completed an exploratory part C evaluating 128 mg/kg.Plasma samples were collected at 10 intervals during a 6-hour period postingestion. Efficacy was

  4. Hot Regions of Noninterfering Crossovers Coexist with a Nonuniformly Interfering Pathway in Arabidopsis thaliana

    PubMed Central

    Basu-Roy, Sayantani; Gauthier, Franck; Giraut, Laurène; Mézard, Christine; Falque, Matthieu; Martin, Olivier C.

    2013-01-01

    In most organisms that have been studied, crossovers formed during meiosis exhibit interference: nearby crossovers are rare. Here we provide an in-depth study of crossover interference in Arabidopsis thaliana, examining crossovers genome-wide in >1500 backcrosses for both male and female meiosis. This unique data set allows us to take a two-pathway modeling approach based on superposing a fraction p of noninterfering crossovers and a fraction (1 − p) of interfering crossovers generated using the gamma model characterized by its interference strength nu. Within this framework, we fit the two-pathway model to the data and compare crossover interference strength between chromosomes and then along chromosomes. We find that the interfering pathway has markedly higher interference strength nu in female than in male meiosis and also that male meiosis has a higher proportion p of noninterfering crossovers. Furthermore, we test for possible intrachromosomal variations of nu and p. Our conclusion is that there are clear differences between left and right arms as well as between central and peripheral regions. Finally, statistical tests unveil a genome-wide picture of small-scale heterogeneities, pointing to the existence of hot regions in the genome where crossovers form preferentially without interference. PMID:24026099

  5. 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

  6. 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.

  7. Hadron-quark crossover and hot neutron stars at birth

    NASA Astrophysics Data System (ADS)

    Masuda, Kota; Hatsuda, Tetsuo; Takatsuka, Tatsuyuki

    2016-02-01

    We construct a new isentropic equation of state (EOS) at finite temperature, "Rover," on the basis of the hadron-quark crossover at high density. By using the new EOS, we study the structure of hot neutron stars at birth with typical lepton fraction (Y_l=0.3-0.4) and typical entropy per baryon (hat {S}=1{-}2). Due to the gradual appearance of quark degrees of freedom at high density, the temperature T and the baryon density ρ at the center of hot neutron stars with hadron-quark crossover are found to be smaller than those without the crossover by a factor of two or more. Typical energy release due to the contraction of a hot neutron star to a cold neutron star with mass M=1.4 M_{⊙} is shown to be about 0.04 M_{⊙}, with a spin-up rate of about 14%.

  8. Regulation of Spatial Selectivity by Crossover Inhibition

    PubMed Central

    Cafaro, Jon; Rieke, Fred

    2013-01-01

    Signals throughout the nervous system diverge into parallel excitatory and inhibitory pathways that later converge on downstream neurons to control their spike output. Converging excitatory and inhibitory synaptic inputs can exhibit a variety of temporal relationships. A common motif is feedforward inhibition, in which an increase (decrease) in excitatory input precedes a corresponding increase (decrease) in inhibitory input. The delay of inhibitory input relative to excitatory input originates from an extra synapse in the circuit shaping inhibitory input. Another common motif is push-pull or “crossover” inhibition, in which increases (decreases) in excitatory input occur together with decreases (increases) in inhibitory input. Primate On midget ganglion cells receive primarily feedforward inhibition and On parasol cells receive primarily crossover inhibition; this difference provides an opportunity to study how each motif shapes the light responses of cell types that play a key role in visual perception. For full-field stimuli, feedforward inhibition abbreviated and attenuated responses of On midget cells, while crossover inhibition, though plentiful, had surprisingly little impact on the responses of On parasol cells. Spatially structured stimuli, however, could cause excitatory and inhibitory inputs to On parasol cells to increase together, adopting a temporal relation very much like that for feedforward inhibition. In this case, inhibitory inputs substantially abbreviated a cell’s spike output. Thus inhibitory input shapes the temporal stimulus selectivity of both midget and parasol ganglion cells, but its impact on responses of parasol cells depends strongly on the spatial structure of the light inputs. PMID:23575830

  9. 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).

  10. 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

  11. Pressure-induced changes of the vibrational modes of spin-crossover complexes studied by nuclear resonance scattering of synchrotron radiation

    NASA Astrophysics Data System (ADS)

    Trautwein, A. X.; Paulsen, H.; Winkler, H.; Giefers, H.; Wortmann, G.; Toftlund, H.; Wolny, J. A.; Chumakov, A. I.; Leupold, O.

    2010-03-01

    Nuclear inelastic scattering (NIS) spectra were recorded for the spin-crossover complexes STP and ETP (STP = [Fe(1,1,1-tris{[N-(2-pyridylmethyl)-N-methylamino]methyl}-ethane)](ClO4)2 and ETP = [Fe(1,1,1-tris{[N-(2-pyridylmethyl)-N-methylamino]methyl}-butane)](ClO4)2) at 30 K and at room temperature and also at ambient pressure and applied pressure (up to 2.6 GPa). Spin transition from the high-spin (HS) to the low-spin (LS) state was observed by lowering temperature and also by applying pressure at room temperature and has been assigned to the hardening of iron-bond stretching modes due to the smaller volume in the LS isomer.

  12. 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)…

  13. 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

  14. 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. PMID:20919793

  15. 24 CFR 3285.701 - Electrical crossovers.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 24 Housing and Urban Development 5 2012-04-01 2012-04-01 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...

  16. 24 CFR 3285.701 - Electrical crossovers.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 24 Housing and Urban Development 5 2014-04-01 2014-04-01 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...

  17. 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...

  18. 24 CFR 3285.701 - Electrical crossovers.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 24 Housing and Urban Development 5 2013-04-01 2013-04-01 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...

  19. 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...

  20. Effects of malted and non-malted whole-grain wheat on metabolic and inflammatory biomarkers in overweight/obese adults: a randomised crossover pilot study.

    PubMed

    Nelson, Kristina; Mathai, Michael L; Ashton, John F; Donkor, Osaana N; Vasiljevic, Todor; Mamilla, Ravikumar; Stojanovska, Lily

    2016-03-01

    Metabolic dysfunction in obesity may be attenuated by whole-grain intake, which has been attributed to synergistic actions of bioactive compounds. Germination/malting may increase grain bioactives, including polyphenols, however biological effects compared with non-germinated grains are unclear. Polyphenols and biological effects were compared between malted-wheat (MLT) and whole-grain wheat (CON) breakfast cereals. Polyphenol content and antioxidant activity were significantly higher (P<0.01 and P<0.05, respectively) in MLT. Corresponding obesity-related biomarkers were measured in 10 overweight/obese adults in a 2×4-week double-blind, randomised, crossover trial. Following both interventions, diastolic blood pressure reduced significantly with time (P<0.05) and low-density lipoprotein increased slightly (P<0.05) over time. A significant time*cereal effect (P<0.05) was found for insulin resistance, decreasing following CON and increasing with MLT. No other significant metabolic or inflammatory differences were found. Whilst MLT contained significantly increased polyphenols, cumulative effects in attenuating obesity-related metabolic dysfunction may require increased consumption. PMID:26471584

  1. 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

  2. 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

  3. High-Resolution Mapping of Crossover and Non-crossover Recombination Events by Whole-Genome Re-sequencing of an Avian Pedigree.

    PubMed

    Smeds, Linnéa; Mugal, Carina F; Qvarnström, Anna; Ellegren, Hans

    2016-05-01

    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

  4. 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.

  5. Studying Recombination with High-Throughput Sequencing: An Educational Primer for Use with “Fine-Scale Heterogeneity in Crossover Rate in the garnet-scalloped Region of the Drosophila melanogaster X chromosome”

    PubMed Central

    Heil, Caiti S. Smukowski; Noor, Mohamed A. F.

    2013-01-01

    An article by Singh and colleagues in this issue of GENETICS quantifies variation in recombination rate across a small region of the Drosophila melanogaster genome, providing an opportunity for instructors of genetics to introduce or reinforce important concepts such as recombination and recombination rate variation, genome sequencing, and sequence features of the genome. Additional background information, a detailed explanation of the methods used in this study, and discussion questions are provided. Related article in GENETICS: Singh, N. D., E. A. Stone, C. F. Aquadro, and A. G. Clark, 2013 Fine-scale heterogeneity in crossover rate in the garnet-scalloped region of the Drosophila melanogaster X chromosome. Genetics 194: 375–387. PMID:23733850

  6. Crossover between work and home in dyadic partner relationships.

    PubMed

    Dikkers, Josje S E; Geurts, Sabine A E; Kinnunen, Ulla; Kompier, Michiel A J; Taris, Toon W

    2007-12-01

    This study aimed at providing insight into the processes underlying crossover between "work" and "home" in dyadic partner relationships. Specifically, we examined to what extent husbands' work demands (work load and overtime hours) and psychological health (fatigue and depressive symptoms) "cross over" to their wives' home demands (home load) and psychological health. These associations were investigated among three couple groups, based on wives' working hours (i.e., more than 20 hours per week, from 1 to 20 hours per week, and not engaged in paid work) (253 couples in total). All husbands worked for at least 35 hours a week. Three possible crossover mechanisms were hypothesized: (i) time-based, (ii) strain-based, and (iii) empathy-based crossover. The results partially supported mechanisms (i) and (ii): when husbands reported higher work load (mechanism i) and more psychological health complaints (mechanism ii), their wives experienced higher home load. The results further supported mechanism (iii) that wives' and husbands' psychological health were associated. It is concluded that crossover from husbands to wives may occur through various mechanisms. PMID:18028075

  7. Size-dependent dielectrophoretic crossover frequency of spherical particles.

    PubMed

    Weng, Ping-You; Chen, I-An; Yeh, Che-Kai; Chen, Pin-Yi; Juang, Jia-Yang

    2016-01-01

    Dielectrophoresis (DEP) has been extensively used in lab-on-a-chip systems for trapping, separating, and manipulating of micro particles suspended in a liquid medium. The most widely used analytic model, the dipole model, provides an accurate prediction on the crossover frequency of submicron particles, but cannot explain the significant drop in crossover frequency of larger particles. Here, we present numerical simulations using the Maxwell stress tensor (MST) and finite element method to study the size effect of the DEP crossover frequency of spherical polystyrene particles suspended in de-ionized water. Our results show that the surface conductance due to the electrical double layer plays a key role, and the size dependency of crossover frequency obtained by the MST method agrees reasonably well with published experimental data. The exponents of the power law are approximately -1.0 and -4.3 for smaller (diameter < 4.6 μm) and larger particles (diameter  > 4.6 μm), respectively. The free surface charge distribution reveals that the charge begins accumulating on the particle equator for particle diameters larger than a critical diameter of 4.6 μm, a result not captured by the dipolar approximation. This method may be extended to analyze bioparticles with complex shapes and composition, and provides new insights into the interpretation of dielectrophoresis applications using lab-on-a-chip systems. PMID:26909121

  8. Ergodic crossover in partially self-avoiding stochastic walks

    NASA Astrophysics Data System (ADS)

    Berbert, Juliana M.; González, Rodrigo Silva; Martinez, Alexandre Souto

    2013-09-01

    Consider a one-dimensional environment with N randomly distributed sites. An agent explores this random medium moving deterministically with a spatial memory μ. A crossover from local to global exploration occurs in one dimension at a well-defined memory value μ1=log2N. In its stochastic version, the dynamics is ruled by the memory and by temperature T, which affects the hopping displacement. This dynamics also shows a crossover in one dimension, obtained computationally, between exploration schemes, characterized yet by the trajectory size (Np) (aging effect). In this paper we provide an analytical approach considering the modified stochastic version where the parameter T plays the role of a maximum hopping distance. This modification allows us to obtain a general analytical expression for the crossover, as a function of the parameters μ, T, and Np. Differently from what has been proposed by previous studies, we find that the crossover occurs in any dimension d. These results have been validated by numerical experiments and may be of great value for fixing optimal parameters in search algorithms.

  9. Ergodic crossover in partially self-avoiding stochastic walks.

    PubMed

    Berbert, Juliana M; González, Rodrigo Silva; Martinez, Alexandre Souto

    2013-09-01

    Consider a one-dimensional environment with N randomly distributed sites. An agent explores this random medium moving deterministically with a spatial memory μ. A crossover from local to global exploration occurs in one dimension at a well-defined memory value μ_{1}=log_{2}N. In its stochastic version, the dynamics is ruled by the memory and by temperature T, which affects the hopping displacement. This dynamics also shows a crossover in one dimension, obtained computationally, between exploration schemes, characterized yet by the trajectory size (N_{p}) (aging effect). In this paper we provide an analytical approach considering the modified stochastic version where the parameter T plays the role of a maximum hopping distance. This modification allows us to obtain a general analytical expression for the crossover, as a function of the parameters μ, T, and N_{p}. Differently from what has been proposed by previous studies, we find that the crossover occurs in any dimension d. These results have been validated by numerical experiments and may be of great value for fixing optimal parameters in search algorithms. PMID:24125225

  10. Ambient fine particulate air pollution triggers ST-elevation myocardial infarction, but not non-ST elevation myocardial infarction: a case-crossover study

    PubMed Central

    2014-01-01

    Background We and others have shown that increases in particulate air pollutant (PM) concentrations in the previous hours and days have been associated with increased risks of myocardial infarction, but little is known about the relationships between air pollution and specific subsets of myocardial infarction, such as ST-elevation myocardial infarction (STEMI) and non ST-elevation myocardial infarction (NSTEMI). Methods Using data from acute coronary syndrome patients with STEMI (n = 338) and NSTEMI (n = 339) and case-crossover methods, we estimated the risk of STEMI and NSTEMI associated with increased ambient fine particle (<2.5 um) concentrations, ultrafine particle (10-100 nm) number concentrations, and accumulation mode particle (100-500 nm) number concentrations in the previous few hours and days. Results We found a significant 18% increase in the risk of STEMI associated with each 7.1 μg/m3 increase in PM2.5 concentration in the previous hour prior to acute coronary syndrome onset, with smaller, non-significantly increased risks associated with increased fine particle concentrations in the previous 3, 12, and 24 hours. We found no pattern with NSTEMI. Estimates of the risk of STEMI associated with interquartile range increases in ultrafine particle and accumulation mode particle number concentrations in the previous 1 to 96 hours were all greater than 1.0, but not statistically significant. Patients with pre-existing hypertension had a significantly greater risk of STEMI associated with increased fine particle concentration in the previous hour than patients without hypertension. Conclusions Increased fine particle concentrations in the hour prior to acute coronary syndrome onset were associated with an increased risk of STEMI, but not NSTEMI. Patients with pre-existing hypertension and other cardiovascular disease appeared particularly susceptible. Further investigation into mechanisms by which PM can preferentially trigger STEMI over NSTEMI

  11. Randomized Crossover Study to Examine the Necessity of an Injection-to-Meal Interval in Patients With Type 2 Diabetes and Human Insulin

    PubMed Central

    Müller, Nicolle; Frank, Thomas; Kloos, Christof; Lehmann, Thomas; Wolf, Gunter; Müller, Ulrich Alfons

    2013-01-01

    OBJECTIVE Patients with diabetes and insulin therapy with human insulin were usually instructed to use an interval of 20–30 min between the injection and meal. We examined the necessity of the injection-to-meal interval (IMI) in patients with type 2 diabetes mellitus (T2DM) and flexible insulin therapy with human insulin. RESEARCH DESIGN AND METHODS In this randomized, open crossover trial, 100 patients with T2DM (47% men, mean age = 66.7 years) were randomized to the IMI first group (phase 1, IMI 20 min; phase 2, no IMI) or IMI last group (phase 1, no IMI; phase 2, IMI 20 min). The main outcome measures were HbA1c, blood glucose profile, incidence of hypoglycemia, quality of life, treatment satisfaction, and patient preference. RESULTS Forty-nine patients were randomized to the IMI first group and 51 patients to the IMI last group. Omitting the IMI only slightly increases HbA1c (average intraindividual difference = 0.08% [95% CI 0.01–0.15]). Since the difference is not clinically relevant, a therapy without IMI is noninferior to its application (P < 0.001). In the secondary outcomes, the incidence of mild hypoglycemia also did not differ between no IMI and IMI significantly (mean of differences = −0.10, P = 0.493). No difference in the blood glucose profile of both groups was found. Treatment satisfaction increased markedly, by 8.08, if IMI was omitted (P < 0.001). The total score of the quality of life measure did not show differences between applying an IMI or not. Insulin therapy without IMI was preferred by 86.5% of patients (P < 0.001). CONCLUSIONS An IMI for patients with T2DM and preprandial insulin therapy is not necessary. PMID:23340895

  12. Crossover from the parity-conserving pair contact process with diffusion to other universality classes.

    PubMed

    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/varphi_{1}=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/varphi_{2}=0.73(4) for the DP-to-DI crossover. The inequality of varphi_{1} and varphi_{2} 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/varphi_{3}=1.23(10) , which is associated with a new independent route from the PCPD to the DP. PMID:19518439

  13. A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial): study rationale and design

    PubMed Central

    2012-01-01

    Background Severe hypoglycaemia still represents a significant problem in insulin-treated diabetes. Most patients do not experience severe hypoglycaemia often. However, 20% of patients with type 1 diabetes experience recurrent severe hypoglycaemia corresponding to at least two episodes per year. The effect of insulin analogues on glycaemic control has been documented in large trials, while their effect on the frequency of severe hypoglycaemia is less clear, especially in patients with recurrent severe hypoglycaemia. The HypoAna Trial is designed to investigate whether short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing the occurrence of severe hypoglycaemic episodes in patients with recurrent hypoglycaemia. This paper reports the study design of the HypoAna Trial. Methods/design The study is a Danish two-year investigator-initiated, prospective, randomised, open, blinded endpoint (PROBE), multicentre, cross-over trial investigating the effect of insulin analogues versus human insulin on the frequency of severe hypoglycaemia in subjects with type 1 diabetes. Patients are randomised to treatment with basal-bolus therapy with insulin detemir / insulin aspart or human NPH insulin / human regular insulin in random order. The major inclusion criterion is history of two or more episodes of severe hypoglycaemia in the preceding year. Discussion In contrast to almost all other studies in this field the HypoAna Trial includes only patients with major problems with hypoglycaemia. The HypoAna Trial will elucidate whether basal-bolus regimen with short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing occurrence of severe hypoglycaemic episodes in hypoglycaemia prone patients with type 1 diabetes. http://www.clinicaltrials.gov: NCT00346996. PMID:22727048

  14. An open-label, phase 2, single centre, randomized, crossover design bioequivalence study of AndroForte 5 testosterone cream and Testogel 1% testosterone gel in hypogonadal men: study LP101.

    PubMed

    Wittert, G A; Harrison, R W; Buckley, M J; Wlodarczyk, J

    2016-01-01

    We compared a novel 5% testosterone (T) cream (AndroForte 5, Lawley Pharmaceuticals, Australia) with a 1% T gel (Testogel, Besins Healthcare, Australia). Using an open-label crossover design, subjects were randomized to one of two treatment sequences using either the T gel or T cream first in a 1 : 1 ratio. Each treatment period was 30 days with a 7-14 days washout period between them. On Days 1 and 30 of each treatment period blood was sampled at -15, -5 min, 0, 2, 4, 5, 6, 7, 8, 9, 10, 12 and 16 h post study drug administration. Sixteen men with established androgen deficiency aged between 29 and 73 years, who had undertaken a washout from prior testosterone therapy participated in the study. One subject failed to complete both arms and another was excluded post-completion because of a major protocol violation. Bioequivalence was established based on key pharmacokinetic (PK) variables: AUC, C(avg), C(max), T(max), % fluctuation (with and without baseline correction) for the two formulations of testosterone on Day 1 and Day 30. The ratio and 90% CI of AUC 0.99 (0.86-1.14), C(max) 1.02 (0.84-1.24) and C(avg) 0.99 (0.86-1.14) for T cream/T gel were within the predetermined bio-equivalence criteria of 80% to 125% at Day 30. There were no statistically significant differences between secondary biochemical markers: serum dihydrotestosterone (DHT), oestradiol (E2), sex hormone-binding globulin (SHBG), luteinizing hormone (LH) and (FSH). The two testosterone formulations were shown to be bioequivalent. PMID:26754331

  15. Pharmacokinetics of Active Components of Yokukansan, a Traditional Japanese Herbal Medicine after a Single Oral Administration to Healthy Japanese Volunteers: A Cross-Over, Randomized Study

    PubMed Central

    Kitagawa, Hiroyuki; Munekage, Masaya; Ichikawa, Kengo; Fukudome, Ian; Munekage, Eri; Takezaki, Yuka; Matsumoto, Takashi; Igarashi, Yasushi; Hanyu, Haruo; Hanazaki, Kazuhiro

    2015-01-01

    Context Yokukansan (YKS) is a traditional Japanese herbal medicine called kampo medicine in Japan. Its extract comprises seven crude drugs: Atractylodis lanceae rhizoma, Poria, Cnidii rhizoma, Uncariae uncis cum ramulus, Angelicae radix, Bupleuri radix, and Glycyrrhizae radix. YKS is used to treat neurosis, insomnia, as well as behavioral and psychological symptoms of dementia. Objective To confirm the exposure and pharmacokinetics of the active components of YKS in healthy volunteers. Design, Setting, and Participants A randomized, open-label, 3-arm, 3-period, crossover trial was conducted on 21 healthy Japanese volunteers at the Kochi Medical University between May 2012 and November 2012. Interventions Single oral administration of YKS (2.5 g, 5.0 g, or 7.5 g/day) during each period. Main Outcome Measure Plasma concentrations of three active compounds in YKS, namely 18β-glycyrrhetinic acid (GA), geissoschizine methyl ether (GM), and hirsuteine (HTE). Results The mean maximum plasma concentrations (Cmax) of GM and HTE increased dose-dependently (ranges: 0.650–1.98 ng/mL and 0.138–0.450 ng/mL, respectively). The times to maximum plasma concentration after drug administration (tmax) were 0.500 h for GM and 0.975–1.00 h for HTE. The apparent elimination half-lives (t1/2) were 1.72–1.95 h for GM and 2.47–3.03 h for HTE. These data indicate the rapid absorption and elimination of GM and HTE. On the other hand, the Cmax, tmax, and t1/2 of GA were 57.7–108 ng/mL, 8.00–8.01 h, and 9.39–12.3 h, respectively. Conclusion We demonstrated that pharmacologically active components of YKS are detected in humans. Further, we determined the pharmacokinetics of GM, HTE, and GA. This information will be useful to elucidate the pharmacological effects of YKS. Trial Registration Japan Pharmaceutical Information Center JAPIC CTI-121811 PMID:26151135

  16. Effect of the dietary supplement Meltdown on catecholamine secretion, markers of lipolysis, and metabolic rate in men and women: a randomized, placebo controlled, cross-over study

    PubMed Central

    Bloomer, Richard J; Canale, Robert E; Blankenship, Megan M; Hammond, Kelley G; Fisher-Wellman, Kelsey H; Schilling, Brian K

    2009-01-01

    Background We have recently reported that the dietary supplement Meltdown® increases plasma norepinephrine (NE), epinephrine (EPI), glycerol, free fatty acids (FFA), and metabolic rate in men. However, in that investigation measurements ceased at 90 minutes post ingestion, with values for blood borne variables peaking at this time. It was the purpose of the present investigation to extend the time course of measurement to 6 hours, and to include women within the design to determine if sex differences to treatment exist. Methods Ten men (24 ± 4 yrs) and 10 women (22 ± 2 yrs) ingested Meltdown® or a placebo, using a randomized, cross-over design with one week separating conditions. Blood samples were collected immediately before supplementation and at one hour intervals through 6 hours post ingestion. A standard meal was provided after the hour 3 collection. Samples were assayed for EPI, NE, glycerol, and FFA. Five minute breath samples were collected at each time for measurement of metabolic rate and substrate utilization. Area under the curve (AUC) was calculated. Heart rate and blood pressure were recorded at all times. Data were also analyzed using a 2 (sex) × 2 (condition) × 7 (time) repeated measures analysis of variance, with Tukey post hoc testing. Results No sex × condition interactions were noted for AUC for any variable (p > 0.05). Hence, AUC data are collapsed across men and women. AUC was greater for Meltdown® compared to placebo for EPI (367 ± 58 pg·mL-1·6 hr-1 vs. 183 ± 27 pg·mL-1·6 hr-1; p = 0.01), NE (2345 ± 205 pg·mL-1·6 hr-1 vs. 1659 ± 184 pg·mL-1·6 hr-1; p = 0.02), glycerol (79 ± 8 μg·mL-1·6 hr-1 vs. 59 ± 6 μg·mL-1·6 hr-1; p = 0.03), FFA (2.46 ± 0.64 mmol·L-1·6 hr-1 vs. 1.57 ± 0.42 mmol·L-1·6 hr-1; p = 0.05), and kilocalorie expenditure (439 ± 26 kcal·6 hrs-1 vs. 380 ± 14 kcal·6 hrs-1; p = 0.02). No effect was noted for substrate utilization (p = 0.39). Both systolic and diastolic blood pressure (p < 0.0001; 1

  17. 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

  18. 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.

  19. 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

  20. Nanoparticles of iron(II) spin-crossover.

    PubMed

    Forestier, Thibaut; Mornet, Stéphane; Daro, Nathalie; Nishihara, Taishi; Mouri, Shin-ichiro; Tanaka, Koichiro; Fouché, Olivier; Freysz, Eric; Létard, Jean-François

    2008-09-28

    We report the synthesis of spin crossover 69 nm spherical nanoparticles of [Fe(NH2-trz)3](Br)2.3H2O.0.03(surfactant) (NH2trz = 4-amino-1,2,4-triazole, surfactant = Lauropal), prepared by the reverse micelle technique, which exhibit at room temperature a thermal hysteresis characterized by magnetic, diffuse reflectivity and Raman studies. PMID:18802559

  1. 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

  2. Strategy Uniform Crossover Adaptation Evolution in a Minority Game

    NASA Astrophysics Data System (ADS)

    Yang, Wei-Song; Wang, Bing-Hong; Quan, Hong-Jun; Hu, Chin-Kun

    2003-10-01

    We propose and study a new adaptation minority game for understanding of the complex dynamical behaviour characterized by agent interactions competing limited resource in many natural and social systems. Intelligent agents may modify a part of strategies held by them periodically, depending on the strategy performances. In the new model, the strategies will be updated according to uniform-crossover variation process inspired by genetic evolution algorithm in biology. The performances of the agents in the new model are calculated for different parameter conditions. It has been found that the new system may evolve via the strategy uniform crossover adaptation mechanism into a frozen equilibrium state in which the performance of the system may reach the best limit, implying the strongest cooperation among agents and the most effective utilization of the social resources.

  3. 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.

  4. Effect of dietary prebiotic supplementation on advanced glycation, insulin resistance and inflammatory biomarkers in adults with pre-diabetes: a study protocol for a double-blind placebo-controlled randomised crossover clinical trial

    PubMed Central

    2014-01-01

    Background Advanced glycation endproducts (AGEs) contribute to the development of vascular complications of diabetes and have been recently implicated in the pathogenesis of diabetes. Since AGEs are generated within foodstuffs upon food processing, it is increasingly recognised that the modern diet is replete with AGEs. AGEs are thought to stimulate chronic low-grade inflammation and promote oxidative stress and have been linked to the development of insulin resistance. Simple therapeutic strategies targeted at attenuating the progression of chronic low-grade inflammation and insulin resistance are urgently required to prevent or slow the development of type 2 diabetes in susceptible individuals. Dietary modulation of the human colonic microbiota has been shown to confer a number of health benefits to the host, but its effect on advanced glycation is unknown. The aim of this article is to describe the methodology of a double-blind placebo-controlled randomised crossover trial designed to determine the effect of 12 week consumption of a prebiotic dietary supplement on the advanced glycation pathway, insulin sensitivity and chronic low-grade inflammation in adults with pre-diabetes. Methods/Design Thirty adults with pre-diabetes (Impaired Glucose Tolerance or Impaired Fasting Glucose) aged between 40–60 years will be randomly assigned to receive either 10 grams of prebiotic (inulin/oligofructose) daily or 10 grams placebo (maltodextrin) daily for 12 weeks. After a 2-week washout period, study subjects will crossover to receive the alternative dietary treatment for 12 weeks. The primary outcome is the difference in markers of the advanced glycation pathway carboxymethyllysine (CML) and methylglyoxal (MG) between experimental and control treatments. Secondary outcomes include HbA1c, insulin sensitivity, lipid levels, blood pressure, serum glutathione, adiponectin, IL-6, E-selectin, myeloperoxidase, C-reactive protein, Toll-like Receptor 4 (TLR4), soluble receptor

  5. Effects of luseogliflozin, a sodium-glucose co-transporter 2 inhibitor, on 24-h glucose variability assessed by continuous glucose monitoring in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled, crossover study.

    PubMed

    Nishimura, R; Osonoi, T; Kanada, S; Jinnouchi, H; Sugio, K; Omiya, H; Ubukata, M; Sakai, S; Samukawa, Y

    2015-08-01

    The aim of the present study was to determine the effects of luseogliflozin on 24-h glucose levels, assessed by continuous glucose monitoring, and on pharmacodynamic variables measured throughout the day. In this double-blind, placebo-controlled, crossover study, 37 patients with type 2 diabetes mellitus inadequately controlled with diet and exercise were randomized into two groups. Patients in each group first received luseogliflozin then placebo for 7 days each, or vice versa. After 7 days of treatment, the mean 24-h glucose level was significantly lower with luseogliflozin than with placebo [mean (95% confidence interval) 145.9 (134.4-157.5) mg/dl vs 168.5 (156.9-180.0) mg/dl; p < 0.001]. The proportion of time spent with glucose levels ≥70 to ≤180 mg/dl was significantly greater with luseogliflozin than with placebo [median (interquartile range) 83.2 (67.7-96.5)% vs 71.9 (46.9-83.3)%; p < 0.001] without inducing hypoglycaemia. The decrease in glucose levels was accompanied by reductions in serum insulin levels throughout the day. PMID:25930989

  6. 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

  7. 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

  8. 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

  9. 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.

  10. Time-dependent couplings and crossover length scales in nonequilibrium surface roughening

    NASA Astrophysics Data System (ADS)

    Pradas, Marc; López, Juan M.; Hernández-Machado, A.

    2007-07-01

    We show that time-dependent couplings may lead to nontrivial scaling properties of the surface fluctuations of the asymptotic regime in nonequilibrium kinetic roughening models. Three typical situations are studied. In the case of a crossover between two different rough regimes, the time-dependent coupling may result in anomalous scaling for scales above the crossover length. In a different setting, for a crossover from a rough to either a flat or damping regime, the time-dependent crossover length may conspire to produce a rough surface, although the most relevant term tends to flatten the surface. In addition, our analysis sheds light into an existing debate in the problem of spontaneous imbibition, where time-dependent couplings naturally arise in theoretical models and experiments.

  11. Fine Scale Analysis of Crossover and Non-Crossover and Detection of Recombination Sequence Motifs in the Honeybee (Apis mellifera)

    PubMed Central

    Bessoltane, Nadia; Toffano-Nioche, Claire; Solignac, Michel; Mougel, Florence

    2012-01-01

    Background Meiotic exchanges are non-uniformly distributed across the genome of most studied organisms. This uneven distribution suggests that recombination is initiated by specific signals and/or regulations. Some of these signals were recently identified in humans and mice. However, it is unclear whether or not sequence signals are also involved in chromosomal recombination of insects. Methodology We analyzed recombination frequencies in the honeybee, in which genome sequencing provided a large amount of SNPs spread over the entire set of chromosomes. As the genome sequences were obtained from a pool of haploid males, which were the progeny of a single queen, an oocyte method (study of recombination on haploid males that develop from unfertilized eggs and hence are the direct reflect of female gametes haplotypes) was developed to detect recombined pairs of SNP sites. Sequences were further compared between recombinant and non-recombinant fragments to detect recombination-specific motifs. Conclusions Recombination events between adjacent SNP sites were detected at an average distance of 92 bp and revealed the existence of high rates of recombination events. This study also shows the presence of conversion without crossover (i. e. non-crossover) events, the number of which largely outnumbers that of crossover events. Furthermore the comparison of sequences that have undergone recombination with sequences that have not, led to the discovery of sequence motifs (CGCA, GCCGC, CCGCA), which may correspond to recombination signals. PMID:22567142

  12. 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.

  13. 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.

  14. 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.

  15. 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

  16. 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%.

  17. 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. PMID:18717569

  18. A Placebo-Controlled, Multicenter, Randomized, Double-Blind, Flexible-Dose, Two-Way Crossover Study to Evaluate the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction

    PubMed Central

    Ergin, Sureyya; Gunduz, Berrin; Ugurlu, Hatice; Sivrioglu, Koncuy; Oncel, Sema; Gok, Haydar; Erhan, Belgin; Levendoglu, Funda; Senocak, Ozlem

    2008-01-01

    Background/Objective: To show the efficacy, safety, and tolerability of sildenafil in men with erectile dysfunction (ED) associated with complete or incomplete spinal cord injury (SCI) and to assess its effects on quality of life (QoL) using the Life-Satisfaction Check List. Methods: This was a placebo-controlled, multicenter, randomized, double-blind, flexible-dose, 2-way crossover study with a 2-week washout period between each phase. Patients with ED attributable to SCI (Sexual Health Inventory—Male score ≤21) received 50 to 100 mg sildenafil (n = 24) or placebo (n = 26). Results: Compared with placebo, sildenafil produced higher levels of successful sexual stimulation, intercourse success, satisfaction with sexual life and sexual relationship, erectile function, overall sexual satisfaction, and an improved Erectile Dysfunction Inventory of Treatment Satisfaction score, with no clinically relevant effects on vital signs. Sildenafil seemed more effective in patients with incomplete SCI than in those with complete SCI, producing significant improvements, compared with placebo, in a number of measures only in patients with incomplete SCI. All patients who expressed a preference selected sildenafil over placebo, although the drug had no effect on patient QoL. Sildenafil was well tolerated, with a profile comparable to that of placebo. Conclusions: Compared with placebo, treatment with oral sildenafil safely and effectively improved erectile function in patients with ED attributable to SCI, especially in those with incomplete injury, and was the agent of choice in those who expressed a preference. PMID:19086709

  19. Captopril at 50 mg as well as at 100 mg once a day reduces blood pressure for up to 24 h: a double-blind randomized crossover study in mild to moderate hypertensives.

    PubMed

    Salvetti, A; Circo, A; Raciti, S; Gulizia, M; Cardillo, R; Miceli, S; Botta, G

    1988-12-01

    The extent and the duration of the antihypertensive effect of captopril, given once a day at a dose of 50 mg, compared with placebo and with the 100 mg once daily dose was studied in 30 mild or moderate uncomplicated essential hypertensives (mean +/- s.e.m. age 52.0 +/- 1.5 years), who responded (mean blood pressure decrease greater than 10%) to a single oral dose (12.5 mg) of captopril. According to a randomized, double-blind, crossover design, they were given 50 mg captopril four times a day, 100 mg captopril four times a day or matched placebo for 1 month. At the end of each treatment period blood pressure and heart rate were measured every 30 min from 3 h before to 2 h after the last dose. Although the heart rate did not change, mean blood pressure after the 50- and 100-mg doses of captopril was consistently significantly (P less than or equal to 0.05) lower than after placebo. The hypotensive effect peaked at the second hour and was still significant 24 h after dosing without any significant differences between the 50- and the 100-mg doses. These findings indicate that captopril, given chronically once a day at a dose of 50 mg to mild to moderate hypertensive responders, exerts its hypotensive effect up to 24 h and that doubling the dose does not increase either the extent or the duration of its action. PMID:3071596

  20. 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.

  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. 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.

  3. 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.

  4. The dynamical crossover in attractive colloidal systems

    NASA Astrophysics Data System (ADS)

    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.

  5. 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. PMID:24320386

  6. Crossover Pedagogy: The Collaborative Search for Meaning

    ERIC Educational Resources Information Center

    Nash, Robert J.

    2009-01-01

    This article describes the author's cross-pedagogical approach to co-teaching with student affairs colleagues. The central goal of this approach is to help students create meaning for their lives. The author also gives an account of an incident that occurred in one seminar and illustrates the benefits of a crossover approach.

  7. 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…

  8. 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 ...

  9. 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

  10. Treatment of children with attention-deficit/hyperactivity disorder: results of a randomized, multicenter, double-blind, crossover study of extended-release dexmethylphenidate and D,L-methylphenidate and placebo in a laboratory classroom setting.

    PubMed

    Silva, Raul; Muniz, Rafael; McCague, Kevin; Childress, Ann; Brams, Matthew; Mao, Alice

    2008-01-01

    The purpose of this study was to compare the efficacy and safety of extended-release dexmethylphenidate (d-MPH-ER) to that of d,l-MPH-ER and placebo in children with attention-deficit/hyperactivity disorder (ADHD) in a laboratory classroom setting. This multicenter, double-blind, crossover study randomized 82 children, 6 to 12 years of age, stabilized on a total daily dose to the nearest equivalent of 40 to 60 mg of d,l-MPH or 20 or 30 mg/day of d-MPH. Patients participated in a screening day and practice day, and were randomized to 1 of 10 sequences of all five treatments in five separate periods. Treatments included d-MPH-ER (20 mg/day), d-MPH-ER (30 mg/day), d,l-MPH-ER (36 mg/day), d,l-MPH-ER (54 mg/day), and placebo. Primary efficacy was measured by the change from predose on the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale-Combined scores at 2-h postdose during the 12-h laboratory assessment (d-MPH-ER 20 mg/day vs. d,l-MPH-ER 36 mg/day). Adverse events were monitored throughout the study period. d-MPH-ER (20 mg/day) was significantly more effective than d,l-MPH-ER (36 mg/day) in the primary efficacy variable, change from predose to 2-h postdose in SKAMP-combined score. In general, d-MPH-ER had an earlier onset of action than d,l-MPH-ER, while d,l-MPH-ER had a stronger effect at 12-h postdose. No serious adverse events were reported. Treatment with either agent was associated with significant improvements in ADHD symptoms. d-MPH-ER and d,l-MPH-ER can be differentiated on what part of the day each is more effective. PMID:18362868

  11. Effects of Silexan on the Serotonin-1A Receptor and Microstructure of the Human Brain: A Randomized, Placebo-Controlled, Double-Blind, Cross-Over Study with Molecular and Structural Neuroimaging

    PubMed Central

    Baldinger, Pia; Höflich, Anna S.; Mitterhauser, Markus; Hahn, Andreas; Rami-Mark, Christina; Spies, Marie; Wadsak, Wolfgang; Lanzenberger, Rupert

    2015-01-01

    Background: Recently, Silexan, a patented active substance comprised of an essential oil produced from Lavandula angustifolia flowers, has been authorized in Germany as a medicinal product for the treatment of states of restlessness related to anxious mood. Its efficacy has been shown in several forms of anxiety disorders. Findings from preclinical and clinical studies attribute a major role to the serotonin-1A receptor in the pathogenesis and treatment of anxiety. Methods: To elucidate the effect of Silexan on serotonin-1A receptor binding, 17 healthy men underwent 2 positron emission tomography measurements using the radioligand [carbonyl-11C]WAY-100635 following the daily intake of 160mg Silexan or placebo for a minimum of 8 weeks (randomized, double-blind, cross-over design). Additionally, structural magnetic resonance imaging and voxel-based morphometry analysis was performed to determine potential effects on gray matter microstructure. Results: Serotonin-1A receptor binding potential was shown to be significantly reduced following the intake of Silexan compared with placebo in 2 large clusters encompassing the temporal gyrus, the fusiform gyrus and the hippocampus on one hand as well as the insula and anterior cingulate cortex on the other hand. No effects of Silexan on gray matter volume could be detected in this investigation. Conclusion: This positron emission tomography study proposes an involvement of the serotonin-1A receptor in the anxiolytic effects of Silexan. The study was registered in the International Standard Randomized Controlled Trial Number Register as ISRCTN30885829 (http://www.controlled-trials.com/isrctn/). PMID:25522403

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

    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

  13. Effects of carbohydrates-BCAAs-caffeine ingestion on performance and neuromuscular function during a 2-h treadmill run: a randomized, double-blind, cross-over placebo-controlled study

    PubMed Central

    2011-01-01

    Background Carbohydrates (CHOs), branched-chain amino acids (BCAAs) and caffeine are known to improve running performance. However, no information is available on the effects of a combination of these ingredients on performance and neuromuscular function during running. Methods The present study was designed as a randomized double-blind cross-over placebo-controlled trial. Thirteen trained adult males completed two protocols, each including two conditions: placebo (PLA) and Sports Drink (SPD: CHOs 68.6 g.L-1, BCAAs 4 g.L-1, caffeine 75 mg.L-1). Protocol 1 consisted of an all-out 2 h treadmill run. Total distance run and glycemia were measured. In protocol 2, subjects exercised for 2 h at 95% of their lowest average speeds recorded during protocol 1 (whatever the condition). Glycemia, blood lactate concentration and neuromuscular function were determined immediately before and after exercise. Oxygen consumption (V˙O2), heart rate (HR) and rate of perceived exertion (RPE) were recorded during the exercise. Total fluids ingested were 2 L whatever the protocols and conditions. Results Compared to PLA, ingestion of SPD increased running performance (p = 0.01), maintained glycemia and attenuated central fatigue (p = 0.04), an index of peripheral fatigue (p = 0.04) and RPE (p = 0.006). Maximal voluntary contraction, V˙O2, and HR did not differ between the two conditions. Conclusions This study showed that ingestion of a combination of CHOs, BCAAs and caffeine increased performance by about 2% during a 2-h treadmill run. The results of neuromuscular function were contrasted: no clear cut effects of SPD were observed. Trial registration ClinicalTrials.gov, http://www.clinicaltrials.gov, NCT00799630 PMID:22152427

  14. 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. PMID:26428277

  15. 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

  16. A cross-over study of the effect of a single oral feeding of medium chain triglyceride oil vs. canola oil on post-ingestion plasma triglyceride levels in healthy men.

    PubMed

    Calabrese, C; Myer, S; Munson, S; Turet, P; Birdsall, T C

    1999-02-01

    Due to its unique absorption and metabolism characteristics, medium chain triglyceride (MCT) oil, consisting of fatty acids with 8-12 carbons, has been used therapeutically since the 1950s in the treatment of fat malabsorption, cystic fibrosis, epilepsy, weight control, and to increase exercise performance. Medium chain triglycerides are easily hydrolyzed in the intestines and the fatty acids are transported directly to the liver via the portal venous system, in contrast to long-chain fatty acids (LCFAs), which are incorporated into chylomicrons for transport through the lymphatic system or peripheral circulation. Medium chain fatty acids (MCFAs) do not require carnitine to cross the double mitochondrial membrane of the hepatocyte, thus they quickly enter the mitochondria and undergo rapid beta-oxidation, whereas most LCFAs are packaged into triglycerides in the hepatocyte. In this single-blind, randomized, cross-over study, 20 healthy men ingested a single dose of either 71 g of MCT oil or canola oil. Blood samples were taken at baseline and at hours one through five post-ingestion to compare the effect of a single oral dosing of MCT oil versus canola oil on post-ingestion plasma triglyceride levels. Mean triglyceride values after canola oil increased 47 percent above baseline (p <0.001), while mean triglyceride values after MCT oil decreased 15 percent from baseline (p <0.001), which is consistent with several other studies involving short- and longer-term feeding with MCT oil. The effect of long-term usage of MCT oil on triglycerides is yet to be established. PMID:9988780

  17. 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

  18. 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

  19. 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

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

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

  1. 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

  2. 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

  3. Hands-Off Time for Endotracheal Intubation during CPR Is Not Altered by the Use of the C-MAC Video-Laryngoscope Compared to Conventional Direct Laryngoscopy. A Randomized Crossover Manikin Study

    PubMed Central

    Schuerner, Philipp; Grande, Bastian; Piegeler, Tobias; Schlaepfer, Martin; Saager, Leif; Hutcherson, Matthew T.; Spahn, Donat R.

    2016-01-01

    Introduction Sufficient ventilation and oxygenation through proper airway management is essential in patients undergoing cardio-pulmonary resuscitation (CPR). Although widely discussed, securing the airway using an endotracheal tube is considered the standard of care. Endotracheal intubation may be challenging and causes prolonged interruption of chest compressions. Videolaryngoscopes have been introduced to better visualize the vocal cords and accelerate intubation, which makes endotracheal intubation much safer and may contribute to intubation success. Therefore, we aimed to compare hands-off time and intubation success of direct laryngoscopy with videolaryngoscopy (C-MAC, Karl Storz, Tuttlingen, Germany) in a randomized, cross-over manikin study. Methods Twenty-six anesthesia residents and twelve anesthesia consultants of the University Hospital Zurich were recruited through a voluntary enrolment. All participants performed endotracheal intubation using direct laryngoscopy and C-MAC in a random order during ongoing chest compressions. Participants were strictly advised to stop chest compression only if necessary. Results The median hands-off time was 1.9 seconds in direct laryngoscopy, compared to 3 seconds in the C-MAC group. In direct laryngoscopy 39 intubation attempts were recorded, resulting in an overall first intubation attempt success rate of 97%, compared to 38 intubation attempts and 100% overall first intubation attempt success rate in the C-MAC group. Conclusion As a conclusion, the results of our manikin-study demonstrate that video laryngoscopes might not be beneficial compared to conventional, direct laryngoscopy in easily accessible airways under CPR conditions and in experienced hands. The benefits of video laryngoscopes are of course more distinct in overcoming difficult airways, as it converts a potential “blind intubation” into an intubation under visual control. PMID:27195693

  4. A randomised, double-blind, placebo controlled cross-over study to determine the gastrointestinal effects of consumption of arabinoxylan-oligosaccharides enriched bread in healthy volunteers

    PubMed Central

    2012-01-01

    Background Prebiotics are food ingredients, usually non-digestible oligosaccharides, that are selectively fermented by populations of beneficial gut bacteria. Endoxylanases, altering the naturally present cereal arabinoxylans, are commonly used in the bread industry to improve dough and bread characteristics. Recently, an in situ method has been developed to produce arabinoxylan-oligosaccharides (AXOS) at high levels in breads through the use of a thermophilic endoxylanase. AXOS have demonstrated potentially prebiotic properties in that they have been observed to lead to beneficial shifts in the microbiota in vitro and in murine, poultry and human studies. Methods A double-blind, placebo controlled human intervention study was undertaken with 40 healthy adult volunteers to assess the impact of consumption of breads with in situ produced AXOS (containing 2.2 g AXOS) compared to non-endoxylanase treated breads. Volatile fatty acid concentrations in faeces were assessed and fluorescence in situ hybridisation was used to assess changes in gut microbial groups. Secretory immunoglobulin A (sIgA) levels in saliva were also measured. Results Consumption of AXOS-enriched breads led to increased faecal butyrate and a trend for reduced iso-valerate and fatty acids associated with protein fermentation. Faecal levels of bifidobacteria increased following initial control breads and remained elevated throughout the study. Lactobacilli levels were elevated following both placebo and AXOS-breads. No changes in salivary secretory IgA levels were observed during the study. Furthermore, no adverse effects on gastrointestinal symptoms were reported during AXOS-bread intake. Conclusions AXOS-breads led to a potentially beneficial shift in fermentation end products and are well tolerated. PMID:22657950

  5. 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

  6. Safety, tolerability and pharmacokinetics of intravenous ghrelin for cancer-related anorexia/cachexia: a randomised, placebo-controlled, double-blind, double-crossover study

    PubMed Central

    Strasser, F; Lutz, T A; Maeder, M T; Thuerlimann, B; Bueche, D; Tschöp, M; Kaufmann, K; Holst, B; Brändle, M; von Moos, R; Demmer, R; Cerny, T

    2008-01-01

    Twenty-one adult patients were randomised to receive ghrelin on days 1 and 8 and placebo on days 4 and 11 or vice versa, given intravenously over a 60-min period before lunch: 10 received 2 μg kg−1 (lower-dose) ghrelin; 11 received 8 μg kg−1 (upper-dose) ghrelin. Active and total ghrelin, growth hormone (GH), and insulin-like growth factor 1 levels were monitored at baseline (4–5 days before day 1), during treatment days, and at end of study (day 17/18). Drug-related adverse events (assessed by NCI-CTC-toxicity criteria and cardiac examination) did not differ between ghrelin and placebo. No grade 3/4 toxicity or stimulation of tumour growth was observed. The peak increase of GH, a biological marker of ghrelin action, was 25 ng ml−1 with lower-dose and 42 ng ml−1 with upper-dose ghrelin. Morning fasting total ghrelin levels were higher (P<0.05) for upper-dose patients at end of study (3580 pg ml−1) than at baseline (990 pg ml−1). Insulin-like growth factor 1 levels did not change. At day 8, 81% of patients preferred ghrelin to placebo as against 63% at the end of study. Nutritional intake and eating-related symptoms, measured to explore preliminary efficacy, did not differ between ghrelin and placebo. Ghrelin is well tolerated and safe in patients with advanced cancer. For safety, tolerance, and patients' preference for treatment, no difference was observed between the lower- and upper-dose group. PMID:18182992

  7. 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

  8. Evaluation of the effect of food and age on the pharmacokinetics of oral netupitant and palonosetron in healthy subjects: A randomized, open-label, crossover phase 1 study.

    PubMed

    Calcagnile, Selma; Lanzarotti, Corinna; Gutacker, Michaela; Jakob-Rodamer, Verena; Peter Kammerer, Klaus; Timmer, Wolfgang

    2015-09-01

    Antiemetic treatment compliance is important to prevent chemotherapy-induced nausea and vomiting, a feared chemotherapy side effect. NEPA, a new oral fixed combination of netupitant, a highly selective NK1 receptor antagonist (RA), and palonosetron, a second-generation 5-HT3 RA, targets dual antiemetic pathways with a single dose. This study investigated the effect of food intake and age on NEPA pharmacokinetics (PK) and safety. In this open-label, single-center, randomized, phase 1 study, 24 adults (18-45 years) received NEPA in a fed or fasted state during the first treatment period and in the alternative state in the next treatment period. Twelve elderly subjects (≥65 years) received NEPA in a fasted state. Blood samples were taken for netupitant and palonosetron PK analysis. In the fed condition, netupitant plasma exposure increased, whereas palonosetron PK parameters were not affected. Furthermore, elderly subjects showed increased netupitant and palonosetron exposure compared with adults. All adverse events were mild/moderate, with constipation and headache the most common. Although food intake and age altered NEPA PK, dose adjustments were not needed, as netupitant and palonosetron exposure increases did not lead to safety concerns in healthy subjects. PMID:27137147

  9. Green tea extract decreases starch digestion and absorption from a test meal in humans: a randomized, placebo-controlled crossover study

    PubMed Central

    Lochocka, Klaudia; Bajerska, Joanna; Glapa, Aleksandra; Fidler-Witon, Ewa; Nowak, Jan K.; Szczapa, Tomasz; Grebowiec, Philip; Lisowska, Aleksandra; Walkowiak, Jaroslaw

    2015-01-01

    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 13C breath test was performed twice. Subjects randomly ingested naturally 13C-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. PMID:26226166

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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 Central

    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. PMID:25133164

  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. PMID:27313852

  16. 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

    2016-05-01

    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

  17. Research: Treatment A randomized crossover study to assess the effect of an oat-rich diet on glycaemic control, plasma lipids and postprandial glycaemia, inflammation and oxidative stress in Type 2 diabetes

    PubMed Central

    McGeoch, S C; Johnstone, A M; Lobley, G E; Adamson, J; Hickson, K; Holtrop, G; Fyfe, C; Clark, L F; Pearson, D W M; Abraham, P; Megson, I L; MacRury, S M

    2013-01-01

    Aims In the UK, lifestyle intervention is first-line management in Type 2 diabetes. It is unclear what type of diet is most efficacious for improving glycaemic control. This study investigated the effects of an oat-enriched diet on glycaemic control, postprandial glycaemia, inflammation and oxidative stress compared with standard dietary advice. Methods In a randomized crossover design, 27 volunteers with Type 2 diabetes, managed on diet and lifestyle only, were observed for two consecutive 8-week periods following either the oat-enriched diet or re-enforced standard dietary advice. Volunteers attended at baseline (habitual intake) and 8 and 16 weeks. Measurements included basic clinical measurements and fasted and postprandial (3-h) glucose and insulin in response to a healthy test meal. Markers of inflammation and oxidative stress, including high-sensitivity C-reactive protein, interleukin 6, interleukin 18, tumour necrosis factor-alpha, adiponectin, thiobarbituric acid reactive substances, oxygen radical antioxidant capacity, oxidized LDL and urinary isoprostanes, were also measured at fasting and in the postprandial period. Results There were no diet-related effects on glycaemic control or glycaemic or insulinaemic responses to the test meal. Total cholesterol (5.1 ± 1.0 vs. 4.9 ± 0.8 mmol/l, P = 0.019) concentrations declined following the oat-enriched diet compared with standard dietary advice. There was a postprandial decline in adiponectin concentration (P = 0.009), but no effect of dietary intervention. None of the measures of oxidative stress or inflammation were altered by the oat-enriched diet compared with standard dietary advice. Conclusion The oat-enriched diet had a modest impact on lipid lowering, but did not impact on oxidative stress or inflammation in these volunteers with Type 2 diabetes. PMID:23668675

  18. Taping across the upper trapezius muscle reduces activity during a standardized typing task - an assessor-blinded randomized cross-over study.

    PubMed

    Takasaki, Hiroshi; Delbridge, Blane Michael; Johnston, Venerina

    2015-02-01

    Clinically, taping is believed to alter muscle activity. The purpose of this study was to investigate: (1) whether taping across the upper trapezius (UT) muscle influenced the level of UT and lower trapezius (LT) muscle activity and the ratio of these activities (UT/LT ratio) during a static typing task; and (2) if the activity of these muscles varied with the application of tensioned taping. Forty-two healthy participants performed a 15-min typing task on three separate occasions under one of three conditions: taping applied perpendicular to the UT fibers with tension; taping without tension; and no taping. Activity of the UT and LT muscles was assessed using surface electromyography. Between conditions, significant differences were found in the change of the normalized amplitude in the UT activity (p=.027) and UT/LT ratio (p=.024) but not in the LT activity (p=.93). Compared with the no taping condition, the UT activity was less in both the tensioned taping (p=.009) and the non-tensioned taping (p=.004). There was no difference between the two taping conditions in the change of the UT (p=.91) activity and the UT/LT ratio (p=.92). In conclusion, both tensioned and non-tensioned taping across the UT muscle reduces its activity during a typing task. PMID:25454291

  19. 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

  20. 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

  1. 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

  2. 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

  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. Problem-Based Training Improves Recognition of Patient Hazards by Advanced Medical Students during Chart Review: A Randomized Controlled Crossover Study

    PubMed Central

    Holderried, Friederike; Heine, Daniel; Wagner, Robert; Mahling, Moritz; Fenik, Yelena; Herrmann-Werner, Anne; Riessen, Reimer; Weyrich, Peter; Zipfel, Stephan; Celebi, Nora

    2014-01-01

    Background Patient chart review is the gold standard for detection of potential patient hazards (i.e. medication errors or failure to follow up actionable results) in both routine clinical care and patient safety research. However, advanced medical students’ ability to read patient charts and to identify patient hazards is rather poor. We therefore investigated whether it is possible to teach advanced medical students how to identify patient hazards independent of context (i.e. cancer versus cardiac failure) in patient charts. Methods All fifth-year medical students in one semester (n = 123) were randomized into two groups. One group (IC) received a patient chart review-training first and then a control-intervention and the other group (CI) received the control-intervention first and then the patient chart review-training. Before and after the teaching sessions, students reviewed different scenarios with standardized fictional patient charts containing 12 common patient hazards. Two blinded raters rated the students’ notes for any patient hazard addressed in the notes using a checklist. The students were blinded to the study question and design. There was no external funding and no harm for the participating students. Results A total of 35 data sets had to be excluded because of missing data. Overall, the students identified 17% (IQR 8–29%) of the patient hazards before the training and 56% (IQR 41–66%) of the patient hazards after the training. At the second assessment students identified more patient hazards than at the first. They identified even more in the third. The effect was most pronounced after the patient chart review training (all p<.01). Conclusion Patient chart review exercises and problem-based patient chart review training improve students’ abilities to recognize patient hazards independent of context during patient chart review. PMID:24586591

  5. Effect of a single brushing with two Zn-containing toothpastes on VSC in morning breath: a 12 h, randomized, double-blind, cross-over clinical study.

    PubMed

    Young, A; Jonski, G

    2011-12-01

    This randomized, double-blind, 12 h clinical study tested the effect of a single brushing with two Zn-containing toothpastes on volatile sulfur compound (VSC) levels in morning breath. The following toothpastes were each tested by all 28 participants: A-Zn toothpaste, B--experimental toothpaste (Zn citrate + PVM/MA copolymer) and C--control toothpaste without Zn. The evening prior to test days participants brushed their teeth for 2 min with 1 g toothpaste. 12 h later and prior to eating or performing oral hygiene, morning breath levels of VSC (H(2)S, CH(3)SH) were analysed by gas chromatography. Subjects then rinsed for 30 s with 5 ml cysteine and breath samples were analysed for H(2)S (H(2)S(cys)). Median VSC (area under the curve) values were compared for A, B and C and the effects of A and B on VSC were compared with C. Toothpaste B was more effective than both toothpastes A and C in reducing H(2)S, CH(3)SH and H(2)S(cys) (p < 0.05). Compared with toothpaste C, toothpastes A and B reduced H(2)S by 35% and 68%, respectively (p = 0.003), and CH(3)SH by 12% and 47%, respectively (p = 0.002). Toothpaste B reduced H(2)S(cys) by 48% compared with toothpaste C (p = 0.001). It is suggested that the superior effect of the experimental toothpaste was most likely due to a higher Zn concentration combined with longer retention of Zn due to the PVM/MA copolymer. PMID:22134057

  6. 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. PMID:26486990

  7. 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

  8. Architectural isomerism in the three-dimensional polymeric spin crossover system [Fe(pmd)2[Ag(CN)2]2]: synthesis, structure, magnetic properties, and calorimetric studies.

    PubMed

    Galet, Ana; Muñoz, M Carmen; Gaspar, Ana B; Real, José A

    2005-11-28

    Two coordination polymers formulated [Fe(pmd)2[Ag(CN)2]2] (pmd = pyrimidine) have been synthesized and characterized. Both polymers, considered to be architectural isomers, display different crystal structures and magnetic properties. Isomer 1 crystallizes in the monoclinic C2/c space group with a = 6.9750(8) angstroms, b = 16.1700(9) angstroms, c = 14.2020(8) angstroms, beta = 97.954(2) degrees, V = 1586.37(14) angstroms3, and Z = 4. The crystal structure of isomer 2 has been studied at 250 and 150 K. At both temperatures, 2 displays the orthorhombic Pccn space group with a = 15.7700(2) [14.8950(2)] angstroms, b = 8.2980(4) [8.1580(4)] angstroms, c = 13.4180(6) [13.3480(5)] angstroms, V = 1755.87(14) [1621.96(10)] angstroms3, and Z = 4 for 250 [150] K. The iron(II) ions define distorted octahedral [FeN6] chromophores in both isomers. The equatorial positions are occupied by four [Ag(CN)2]- bridging ligands, which connect the defining layers of two iron(II) ions. Isomer 1 has two crystallographically distinct [Ag(CN)2]- groups; one is essentially linear, while the other is severely distorted [C(5)-Ag(2)-C(5i)] = 138.8(5) degrees. This fact facilitates the parallel interpenetration of two layers, which in addition show short Ag(1)....Ag(2) interactions (distance Ag(1)....Ag(2) = 2.9972(10) angstroms). Isomer 2 shows only one type of Ag atom, which is slightly bent [C-Ag-C = 161.54(12) degrees], and as a consequence, the layers defined are not interpenetrated. In both cases, the axial positions are occupied by the pmd ligands which interact with the Ag atoms of adjacent layers defining a 3D coordination polymer. Compound 1 is high spin in the whole range of temperatures, while 2 undergoes a cooperative high-spin <--> low-spin effect centered at ca. 184 K with a hysteresis loop ca. 5 K wide. The experimental enthalpy and entropy variations were 11.5 +/- 0.4 kJ mol(-1) and 64 +/- 3 J K(-1) mol(-1). Consistency between the experimental thermodynamic data and the

  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. 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

  11. 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.

  12. 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.

  13. 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.

  14. 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

  15. 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

  16. Brain histamine H1 receptor occupancy of orally administered antihistamines measured by positron emission tomography with 11C-doxepin in a placebo-controlled crossover study design in healthy subjects: a comparison of olopatadine and ketotifen

    PubMed Central

    Tashiro, Manabu; Mochizuki, Hideki; Sakurada, Yumiko; Ishii, Kenji; Oda, Keiichi; Kimura, Yuichi; Sasaki, Toru; Ishiwata, Kiichi; Yanai, Kazuhiko

    2006-01-01

    Aims The strength of sedation due to antihistamines can be evaluated by using positron emission tomography (PET). The purpose of the present study is to measure histamine H1 receptor (H1R) occupancy due to olopatadine, a new second-generation antihistamine and to compare it with that of ketotifen. Methods Eight healthy males (mean age 23.5 years-old) were studied following single oral administration of olopatadine 5 mg or ketotifen 1 mg using PET with 11C-doxepin in a placebo-controlled crossover study design. Binding potential ratio and H1R occupancy were calculated and were compared between olopatadine and ketotifen in the medial prefrontal (MPFC), dorsolateral prefrontal (DLPFC), anterior cingulate (ACC), insular (IC), temporal (TC), parietal (PC), occipital cortices (OC). Plasma drug concentration was measured, and correlation of AUC to H1R occupancy was examined. Results H1R occupancy after olopatadine treatment was significantly lower than that after ketotifen treatment in the all cortical regions (P < 0.001). Mean H1R occupancies for olopatadine and ketotifen were, respectively: MPFC, 16.7 vs. 77.7; DLPFC, 14.1 vs. 85.9; ACC, 14.7 vs. 76.1; IC, 12.8 vs. 69.7; TC, 12.5 vs. 66.5; PC, 13.9 vs. 65.8; and OC, 19.5 vs. 60.6. Overall cortical mean H1R occupancy of olopatadine and ketotifen were 15% and 72%, respectively. H1R occupancy of both drugs correlated well with their respective drug plasma concentrations (P < 0.001). Conclusion It is suggested that 5 mg oral olopatadine, with its low H1R occupancy and thus minimal sedation, could safely be used an antiallergic treatment for various allergic disorders. Abbreviations histamine H1 receptor (H1R), histamine H1 receptor occupancy (H1RO), dopamine D2 receptor (D2R), positron emission tomography (PET), blood–brain barrier (BBB), binding potential ratio (BPR), distribution volume (DV) PMID:16390347

  17. Is there a potential application of a fermented nutraceutical in acute respiratory illnesses? An in-vivo placebo-controlled, cross-over clinical study in different age groups of healthy subjects.

    PubMed

    Marotta, F; Naito, Y; Jain, S; Lorenzetti, A; Soresi, V; Kumari, A; Carrera Bastos, P; Tomella, C; Yadav, H

    2012-01-01

    The role of oxidants in viral diseases is fairly complex because it includes metabolic regulation both of host metabolism and viral replication. However, a role for reactive oxygen species (ROS) and reactive nitrogen species (RNS) as mediators of virus-induced lung damage is supported by studies and antioxidants can thus be expected to act at many different levels. The aim of the present pilot study was to test an antioxidant nutraceutical approach on some relevant immunological parameters known to be affected in common seasonal respiratory tract infection. The study population consisted of 90 sedentary healthy patients, previously selected as being GSTM1-positive, divided into three groups: A) 20-40 years; B) 41-65 years; B) over 65 years. Each patients was administered a life style and dietary questionnaire. Subjects were supplemented for 6 weeks with either 9g/day (4.5g twice a day sublingually) of a fermented papaya preparation (Osato Research Institute, Gifu, Japan) or placebo. After a further month period of wash out, subjects were treated again in a crossover manner. Parameters checked were as follows: routine blood tests with WBC formula, saliva flow rate and secretary IgA and lysozyme production and redox gene expression of Phase II enzyme and SOD from upper airways cells (from nasal lavage). Salivary secretion rate showed an age-related decline and was significantly increased by FPP supplementation only in the youngest age-group (p less than 0.05). Subjects treated with FPP showed a significantly higher lever of IgA and lisozyme production., irrespective of age group while their baseline production was significantly lower in the oldest age-group as compared to the youngest one (C vs A, p less than 0.05). FPP treatment brought about a significant upregulation of all phase II enzyme and SOD gene expression tested in nasal lavage cells. In conclusion, FPP supplementation during 1 month resulted in higher salivary IgA and increase in phase II and SOD enzyme

  18. Impact of the cosmetic mouthwash “Jack Pro Spülung plus” (“rheodol-Spülung plus”) on the oral cavity flora, tested in a monocentric, controlled, randomized, blind, cross-over comparative study

    PubMed Central

    Göhring, Jana; Müller, Gerald; Biffar, Reiner; Kramer, Axel

    2014-01-01

    Aim: Jack Pro Spülung Plus (also available as “rheodol-Spülung plus”) is recommended to mechanically maintain oral hygiene as part of an overall oral hygiene concept. Because Jack Pro Spülung Plus contains the active agents polihexanide and tosylchloramide sodium in concentrations below microbicidal efficacy, this study tested the hypothesis that the combination of mechanical rinsing and bacteriostatic effect surpasses the effect of mechanical rinsing alone. Method: The study was performed with 30 volunteers as a monocentric, controlled, randomized, blind, cross-over comparative study. The efficacy of the test product (active agents polihexanide 0.02–0.03% and tosylchloramide sodium 0.004–0.006%) was compared to an aqueous solution of polihexanide (0.02–0.03%) and to Ringer solution as negative control. The efficacy was measured as the reduction of colony forming units (cfu) on buccal mucosa after aerobic and anaerobic cultivation. After determination of pre-values, the volunteers performed mouthrinsing for 30 sec with each of the 3 tested solutions. After 1, 10 and 60 minutes, cfu numbers were determined again. The reduction factor was calculated as the difference between log10 of the measured cfu before and after mouthrinsing with the test solution. The sampling was performed using a template with a smear area of 1 x 1 cm. Results: Using Ringer solution led to a slight mechanically-induced reduction of cfu in the oral cavity 1 min after rinsing the mouth cavity with the solution. After 10 min and 60 min, no influence on the cfu number could be detected. Using Jack pro Spülung Plus led to a bacteriostatic effect up to 60 min after mouthrinsing; 10 min and 60 min after rinsing the efficacy of Ringer solution was also significantly surpassed. The aqueous solution of polihexanide was less effective than Jack pro Spülung Plus after 10 and 60 min. Conclusion: Based on these observations, we conclude that Jack pro Spülung Plus is suitable for improvement

  19. 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

  20. Threshold Levels of Infant and Under-Five Mortality for Crossover between Life Expectancies at Ages Zero, One and Five in India: A Decomposition Analysis

    PubMed Central

    Dubey, Manisha

    2015-01-01

    Objectives Under the prevailing conditions of imbalanced life table and historic gender discrimination in India, our study examines crossover between life expectancies at ages zero, one and five years for India and quantifies the relative share of infant and under-five mortality towards this crossover. Methods We estimate threshold levels of infant and under-five mortality required for crossover using age specific death rates during 1981–2009 for 16 Indian states by sex (comprising of India’s 90% population in 2011). Kitagawa decomposition equations were used to analyse relative share of infant and under-five mortality towards crossover. Findings India experienced crossover between life expectancies at ages zero and five in 2004 for menand in 2009 for women; eleven and nine Indian states have experienced this crossover for men and women, respectively. Men usually experienced crossover four years earlier than the women. Improvements in mortality below ages five have mostly contributed towards this crossover. Life expectancy at age one exceeds that at age zero for both men and women in India except for Kerala (the only state to experience this crossover in 2000 for men and 1999 for women). Conclusions For India, using life expectancy at age zero and under-five mortality rate together may be more meaningful to measure overall health of its people until the crossover. Delayed crossover for women, despite higher life expectancy at birth than for men reiterates that Indian women are still disadvantaged and hence use of life expectancies at ages zero, one and five become important for India. Greater programmatic efforts to control leading causes of death during the first month and 1–59 months in high child mortality areas can help India to attain this crossover early. PMID:26683617

  1. Modeling the covariance structure in pharmacokinetic crossover trials.

    PubMed

    Lindsey, J K; Wang, J; Byrom, W D; Jones, B

    1999-08-01

    Pharmacokinetic studies of drug and metabolite concentrations in the blood are usually conducted as crossover trials, especially in phases I and II. A longitudinal series of measurements is collected on each subject within each period. However, much of the dependence among such observations, within and between periods, is generally ignored in analyzing this type of data. Usually, only a random coefficient model is fitted for the parameters in the nonlinear mean function, along with allowing the variance to depend on the mean so that it changes over time. Here, we develop models to allow more fully for the structure of the crossov