Analysis was by intention to treat for safety and per protocol for immunogenicity .


Because of the small sample size , no detailed comparison of adverse event rates were warranted .


The trial is registered with ClinicalTrials.gov , number NCT@ .


We randomly assigned @ patients to one of the four study groups : @ participants ( @ % ) received low-dose vaccine and eight participants ( @ % ) received placebo in the low-dose groups ; @ participants ( @ % ) received high-dose vaccine , with nine ( @ % ) participants assigned to receive placebo .


Both formulations were well tolerated with mostly mild and transient local or systemic reactions .


No clinically meaningful differences were recorded in the overall incidence of local and systemic adverse events between patients in the vaccine and placebo groups ; @ ( @ % ) of @ participants in the vaccine groups had solicited systemic adverse events compared with @ ( @ % ) of @ of those in the placebo groups .


By contrast , @ participants ( @ % ) in the vaccine group had local solicited reactions compared with five ( @ % ) participants in the placebo group .


Immunisation with either high-dose or low-dose DENVax formulations induced neutralising antibody responses to all four dengue virus serotypes ; @ days after the second dose , @ ( @ % ) of @ participants given vaccine seroconverted to all four serotypes and @ ( @ % ) participants seroconverted to three or more dengue viruses .


Infectious DENVax viruses were detected in only ten ( @ % ) of @ participants in the low-dose group and @ ( @ % ) of @ participants in the high-dose group .


Our findings emphasise the acceptable tolerability and immunogenicity of the tetravalent DENVax formulations in healthy , flavivirus-naive adults .


Further clinical testing of DENVax in different age groups and in dengue-endemic areas is warranted .


To study the role of mometasone furoate aqueous nasal spray for the management of adenoidal hypertrophy in children with more than @ per cent obstruction , and to assess its impact on change in quality of life .


A prospective , randomised , double-blind , interventional placebo-controlled study was conducted .


A total of @ children aged @-@ years completed treatment and follow up .


The symptoms and degree of obstruction were evaluated by nasopharyngoscopy conducted pre-treatment and @ weeks post-treatment .


Subjects received mometasone furoate nasal spray at a daily dose of @g for @ weeks , followed by a dose of @g on alternate days for @ weeks .


RESULTS were compared with those of a matched control group who were given saline nasal spray .


With mometasone treatment , there was an @ per cent reduction in clinical symptom score , and the degree of obstruction dropped from @ to @ per cent ( p < @ ) .


A statistically significant change in quality of life scores was seen in patients treated with the mometasone nasal spray ( score change of @ ) as compared with those given saline nasal spray ( score change of @ ) ( p = @ ) .


Mometasone nasal spray appears to be effective in treating children with obstructive adenoids .


To observe the effect of Ningdong Granule ( NG ) on serum levels of interleukin-@ ( IL-@ ) and tumor necrosis factor-alpha ( TNF-alpha ) of children patients with Tourette 's syndrome ( TS ) .


Totally @ TS children patients were randomly assigned to the NG group , the NG + Tiapride group ( abbreviated as the combined treatment group ) , and the Tiapride group , @ in each group .


Besides , another @ healthy children were recruited as the healthy control group .


Patients in the NG group were treated with NG ( consisting of all gastrodia rhizome , Codonopsis pilosula , Ophiopogon japonicus , white peony root , Rhinocerotidae , oyster , earthworm , licorice root , etc. ) , one dose daily , administered by dissolving it in boiled water , taken in two portions in the morning and in the evening respectively .


Patients in the Tiapride group took Tiapride Tablet , @ -@ mg each time , twice daily .


The dosage was adjusted according to individual difference and changes of pathogenic conditions .


The maximal dosage was @ mg per day .


Those in the combined treatment group were treated with equal dose of NG and Tiapride Tablet in combination .


The treatment course was @ months for all .


Changes of pathogenic condition before and after treatment were assessed by Yale global tic severity scale ( YGTSS ) .


Serum levels of IL-@ and TNF-alpha were detected by enzyme-labeled immunosorbent assay ( ELISA ) before and after treatment .


( @ ) The total effective rate of the NG group , the combined treatment group , and the Tiapride group was @ % , @ % , and @ % , respectively .


It was the lowest in the Tiapride group ( P < @ ) .


It was significantly higher in the combined treatment group than in the NG group ( P < @ ) .


( @ ) The post-treatment YGTSS score was obviously lower in each group after treatment than before treatment ( P < @ ) .


The posttreatment YGTSS score was obviously lower in the NG group and the combined treatment group than in the Tiapride group ( P < @ ) , but with no statistical difference between the fromer two groups ( P > @ ) .


( @ ) Compared with the healthy control group before treatment , serum levels of IL-@ and TNF-alpha ( pg/mL ) were @ + / - @ and @ + / - @ in the NG group , @ + / - @ and @ + / - @ in the combined treatment group , @ + / - @ and @ + / - @ in the Tiapride group , being higher than those in the healthy control group ( @ + / - @ and @ + / - @ ; P < @ ) .


After treatment , serum levels of of IL-@ and TNF-alpha were @ + / - @ and @ + / - @ in the NG group , @ + / - @ and @ + / - @ in the combined treatment group , significantly lower than before treatment ( P < @ ) .


But there was no statistical difference in serum levels of IL-@ or TNF-alpha in the Tiapride group between before treatment ( @ + / - @ and @ + / - @ ) and after treatment ( @ + / - @ and @ + / - @ ; P > @ ) .


NG could modulate abnormal serum levels of IL-@ and TNF-alpha in TS children patients , which might be one of its pharmacodynamic mechanisms for treating TS .


To evaluate the effect of certolizumab pegol ( CZP ) on productivity outside and within the home , and on participation in family , social and leisure activities in adult patients with psoriatic arthritis ( PsA ) .


RAPID-PsA ( NCT@ ) is a phase @ , double-blind , placebo-controlled trial .


@ patients with active PsA were randomised @:@:@ to placebo , CZP @mg every @weeks ( Q@W ) or CZP @mg every @weeks ( Q@W ) .


The arthritis-specific Work Productivity Survey ( WPS ) assessed the impact of PsA on paid work and household productivity , and participation in social activities during the preceding month .


WPS responses were compared between treatment arms using a non-parametric bootstrap-t method .


At baseline , @ % , @ % and @ % of placebo , CZP @mg Q@W and CZP @mg Q@W patients were employed .


By week @ , employed CZP patients reported an average of @-@ @ and @-@ @ fewer days of absenteeism and presenteeism , respectively , per month compared with @ and @ fewer days for placebo patients ( p < @ ) .


Within the home , by week @ , CZP patients reported an average of @-@ @ household work days gained per month versus @ day for placebo ( p < @ ) .


CZP patients also reported fewer days with reduced household productivity or days lost for participation in family , social and leisure activities .


Improvements with CZP were seen as early as week @ and continued to week @ .


CZP treatment significantly improved productivity at paid work and within the home , and resulted in greater participation in social activities for PsA patients .


Two double-blind , randomized studies were conducted to assess the tolerability , pharmacokinetics and pharmacodynamics of oral TA-@ , a new cholesteryl ester transfer protein ( CETP ) inhibitor , in healthy subjects .


Study @ : Subjects received single doses of TA-@ or placebo ( fasted ) .


Doses were @ , @ , @ , @ ( fed/fasted ) , @ and @mg ( Caucasian males , @-@years ) , @mg ( Caucasian males , > @years and Caucasian females , @-@years ) , @ , @ , @ and @mg ( Japanese males , @-@years ) .


Study @ : Caucasian males ( @-@years ) received @ , @ , @ or @mg once daily TA-@ or placebo for @-@days .


Blood and urine for pharmacokinetics and/or pharmacodynamics were collected .


Tolerability was assessed by adverse events , vital signs , electrocardiograms and laboratory safety tests .


Peak TA-@ concentrations occurred approximately @h post-dose .


Mean half-lives ranged from @ to @h , without an obvious dose relationship .


Exposure increased less than proportionally to dose .


TA-@ was not excreted in urine .


Following @ to @mg once daily dosing , TA-@ demonstrated nearly complete inhibition of CETP activity ( @-@ % ) , increased high density lipoprotein-cholesterol ( HDL-C ) by @ to @ % and decreased low density liporotein-cholesterol ( LDL-C ) by @ % to @ % .


There were dose-related increases in apolipoproteins A-@ and E , HDL@-C and HDL@-C , and decreases in apolipoprotein B and lipoprotein A.


There was no evidence of significant effects of age , gender , ethnicity or food on pharmacokinetics or pharmacodynamics .


All doses were well tolerated .


TA-@ is a potent CETP inhibitor and warrants further investigation .


Limited data exist regarding the efficacy of metoclopramide in the treatment of intractable hiccups .


This study aimed to assess the feasibility efficacy of metoclopramide in the treatment of patients with intractable hiccups .


A total of @ patients with intractable hiccups was randomly assigned to arm A ( n = @ ) or arm B ( n = @ ) in a multicentre , double-blind , randomised , controlled pilot study .


Participants in arm A received @-mg metoclopramide thrice daily for @ days , whereas those assigned to arm B received @-mg placebo thrice daily for @ days .


The primary outcome measure was total efficacy against hiccups ( including cessation and improvement of hiccups ) .


Secondary outcome measures included a comparison of overall efficacy and adverse events between the two arms .


Of the @ patients enrolled , @ participants completed the study .


The total efficacy was higher in arm A than in arm B ( relative risk , @ ; @ % confidence interval : @-@ @ , P = @ ) .


Furthermore , comparison between the two arms revealed that overall efficacy was higher in arm A than that in arm B ( P < @ ) .


No serious adverse events related to the treatment were documented in either arm .


The most common adverse events occurring in patients in arm A included fatigue , upset mood and dizziness .


Metoclopramide appears to be a promising candidate for the treatment of patients with intractable hiccups , with mild adverse events .


However , further clinical trials are required to confirm these results .


Plain packaging requires tobacco products to be sold in packs with a standard shape , method of opening and colour , leaving the brand name in a standard font and location .


We ran a randomised controlled trial to investigate the impact of plain packaging on smoking behaviour and attitudes .


In a parallel group randomised trial design , @ daily smokers smoked cigarettes from their usual UK brand , or a plain Australian brand that was closely matched to their usual UK brand for @ hours .


Primary outcomes were number of cigarettes smoked and volume of smoke inhaled per cigarette .


Secondary outcomes were self-reported ratings of motivation to quit , cigarette taste , experience of using the pack , experience of smoking , attributes of the pack , perceptions of the health warning , changes in smoking behaviour , and views on plain packaging .


There was no evidence that pack type had an effect on either of the primary measures ( ps > @ ) .


However , smokers using plain cigarette packs rated the experience of using the pack more negatively ( -@ , @ % CI -@ to -@ , p = @ ) , rated the pack attributes more negatively ( -@ , @ % CI -@ to -@ , p < @ ) , and rated the health warning as more impactful ( +@ , @ % CI @ to @ , p < @ ) .


Plain cigarette packs reduce ratings of the experience of using the cigarette pack , and ratings of the pack attributes , and increase the self-perceived impact of the health warning , but do not change smoking behaviour , at least in the short term .


Until now , working memory training has not reached sufficient evidence as effective treatment for ADHD core symptoms in children with ADHD ; for young children with ADHD , no studies are available .


To this end , a triple-blind , randomized , placebo-controlled study was designed to assess the efficacy of Cogmed Working Memory Training ( CWMT ) in young children with ADHD .


Fifty-one children ( @-@years ) with a DSM-IV-TR diagnosis of ADHD ( without current psychotropic medication ) were randomly assigned to the active ( adaptive ) or placebo ( nonadaptive ) training condition for @ sessions during @ weeks .


The compliance criterion ( > @ sessions ) was met for @ children .


The primary outcome measure concerned the core behavioural symptoms of ADHD , measured with the ADHD Rating Scale IV ( ADHD-RS ) .


Secondary outcome measures were neurocognitive functioning , daily executive functioning , and global clinical functioning .


The influence of the increase in difficulty level ( Index-Improvement ) for the treatment group was also analysed .


Clinical trial registration information - ` Working Memory Training in Young ADHD Children ' ; www.clinicaltrials.gov ; NCT@ .


A significant improvement in favour of the active condition was found on a verbal working memory task ( p = @ ; adapted Digit Span WISC-III , backward condition ) .


However , it did not survive correction for multiple testing .


No significant treatment effect on any of the primary or other secondary outcome measurements was found .


The Index-Improvement significantly contributed to ADHD-RS and the Behavior Rating Inventory of Executive Function , both rated by the teacher , but revealed no significant group difference .


This study failed to find robust evidence for benefits of CMWT over the placebo training on behavioural symptoms , neurocognitive , daily executive , and global clinical functioning in young children with ADHD .


In our previous randomised controlled trial ( RCT ) , we have shown in preterm babies ( PBs ) < @weeks gestation that CeasIng Cpap At standarD criteriA ( CICADA ( method @ ) ) compared with cycling off continuous positive airway pressure ( CPAP ) gradually ( method @ ) or cycling off CPAP gradually with low flow air/oxygen during periods off CPAP ( method @ ) reduces CPAP cessation time in PBs < @weeks gestation .


This retrospective study reviewed weight gain , time to reach full feeds and time to cease caffeine in PBs previously enrolled in the RCT .


Data were collected from @ of the @ PBs , and there was no significant difference in the projected weight gain between the three methods .


Based on intention to treat , the time taken to reach full feeds for all three methods showed no significant difference .


However , post hoc analysis showed the CICADA method compared with cycling off gradually just failed significance ( @ vs @ ( weeks corrected gestational age ( Wks CGASD ) ) , p = @ ) .


Analysis of time to cease caffeine showed there was a significant difference between the methods with PBs randomised to the CICADA method compared with the cycling off method ceasing caffeine almost a week earlier ( @ vs @ ( Wks CGASD ) , p = @ ) .


This retrospective study provides evidence to substantiate the optimum method of ceasing CPAP ; the CICADA method , does not adversely affect weight gain , time to reach full feeds and may reduce time to cease caffeine in PBs < @weeks gestation .


The effect of intracoronary adenosine ( ADO ) on ST-segment elevation myocardial infarction ( STEMI ) size and adverse remodeling is not well established .


In a double-blind trial , @ patients with STEMI were randomized to receive percutaneous coronary intervention ( PCI ) within @ hours of symptom onset , @ mg ADO or saline immediately prior to reperfusion .


Primary end-point : percentage of total myocardial necrotic mass by cardiac magnetic resonance ( CMR ) @-@ days post-reperfusion .


Secondary end-points : changes in left ventricular volumes and ejection fraction ( LVEF ) at baseline and at @ months .


Baseline CMR could not be performed in @ patients .


Overall , no significant differences were observed between ADO and placebo regarding infarct size ( @ % vs. @ % ; p = @ ) .


However , infarct size was significantly reduced ( @ % vs. @ % ; p for interaction = @ ) in those with ischemia duration below the median ( @ min ) .


CMR at @ months , performed in @ patients , did not show statistically significant differences between groups in the rate of LVEF increase ( @ units ( SD @ ) in ADO group vs. @ units ( SD @ ) in placebo group ; p = @ ) .


In the subgroup analysis , among patients with ischemia time below @ min , the increase in LVEF was slightly higher with ADO ( @ % vs. @ % ; p for interaction = @ ) .


Although our study failed to demonstrate that intracoronary administration of ADO prior to PCI limits infarct size , in patients receiving early PCI ADO might enhance myocardial salvage and has a favorable effect on LVEF evolution , which may help to reconcile apparently contradictory results of previous studies .


To evaluate aripiprazole once-monthly ( AOM ) , a long-acting injectable suspension of aripiprazole , as acute treatment in patients with schizophrenia ( DSM-IV-TR ) .


Adults experiencing an acute psychotic episode were randomized to @ weeks of double-blind treatment with AOM @ mg or placebo ( October @-August @ ) .


The primary efficacy outcome was change from baseline to endpoint ( week @ ) in Positive and Negative Syndrome Scale ( PANSS ) total score .


The key secondary efficacy outcome was change from baseline in Clinical Global Impressions-Severity of Illness scale ( CGI-S ) score .


Secondary efficacy outcomes included change from baseline in PANSS positive and negative subscale and Personal and Social Performance Scale ( PSP ) scores .


The study took place from October @ through August @ .


Patients ( N = @ ; @ % male , @ % black ) were randomized to AOM ( n = @ ) or placebo ( n = @ ) .


Least squares ( LS ) mean change from baseline to endpoint ( week @ ) favored AOM versus placebo in PANSS total ( treatment difference , -@ -LSB- @ % CI , -@ to -@ -RSB- ; P < @ ) and CGI-S ( treatment difference , -@ -LSB- @ % CI , -@ to -@ -RSB- ; P < @ ) scores , as it did at all other timepoints through @ weeks ( all P @ ) .


LS mean change from baseline in PANSS positive and negative subscale and PSP scores favored AOM versus placebo ( P < @ ) .


Common ( > @ % ) treatment-emergent adverse events ( AOM vs. placebo ) were increased weight ( @ % vs @ % ) , headache ( @ % vs. @ % ) , and akathisia ( @ % vs @ % ) .


Symptoms and functioning improved with AOM @ mg versus placebo in patients with acute schizophrenia , with acceptable safety and tolerability .


These data suggest that AOM @ mg is a viable treatment option for patients experiencing an acute schizophrenia episode .


This study investigated the short-term effects of Kinesio taping ( KT ) on various types of pain , active range of motion ( AROM ) , and proprioception in patients with knee osteoarthritis .


Forty-six older participants ( mean -LSB- SD -RSB- , @ -LSB- @ -RSB- yrs ) with osteoarthritis were randomly allocated to two groups : the KT group or the placebo-KT group .


Taping with tension ( KT application ) or without tension ( placebo-KT application ) was applied to the quadriceps of the participants in both groups .


Before and after intervention , pain intensity was measured using a visual analog scale at rest and during walking , and pressure pain thresholds ( PPTs ) were assessed using an algometer in the quadriceps and the tibialis anterior .


In addition , pain-free AROM and proprioception were measured .


The KT group showed attenuation of pain during walking ( effect size -LSB- ES -RSB- , @ ) , PPT in the quadriceps ( ES , @ ) , and PPT in the tibialis anterior ( ES , @ ) .


This group also showed significantly improved AROM ( ES , @ ) and proprioception ( ES , @-@ @ ; P < @ ) .


However , the placebo-KT group did not show significant changes in pain , AROM , or proprioception .


There were significant differences between the two groups in pain during walking and PPT .


In addition , pain during walking showed a significant correlation with AROM and proprioception , and a significant correlation was found between PPT and AROM .


These results demonstrated that KT application with proper tension to the quadriceps effectively attenuates various types of pain and improves AROM and proprioception in osteoarthritis patients .


Thus , KT may be a suitable intervention to improve pain , AROM , and proprioception in patients with osteoarthritis in clinics .


The literature on the relationship of depressive symptoms and stress hormones after cancer diagnosis has been mixed , with some studies showing a relationship and other studies showing none .


Time since diagnosis may explain these contradictory findings .


This study examined the relationship of depressive symptoms to stress hormones in patients with breast cancer using @-month longitudinal data .


Patients with Stage II or III breast cancer ( n = @ ) were assessed every @ months from diagnosis/surgery to @ months .


They completed the Centers for Epidemiological Studies Depression Scale ( CES-D ) Iowa Short Form and the Perceived Stress Scale and blood samples were obtained to measure stress hormones ( i.e. , cortisol , adrenocorticotropin hormone , norepinephrine , and epinephrine ) .


Depressive symptoms were negatively related to cortisol levels ( = -@ , p = @ ) but were positively related to rate of change in cortisol ( = @ , p = @ ) .


Adrenocorticotropin hormone , epinephrine , and norepinephrine did not covary with depressive symptoms ( all p values > @ ) .


When the CES-D and Perceived Stress Scale were both used to predict cortisol , only the CES-D was significantly related ( = -@ , p = @ ) .


Depressive symptoms were negatively related to cortisol , but this relationship changed from the time of diagnosis/surgery through @ months .


Cortisol may initially provide a buffering effect against depression during the stress of initial diagnosis and treatment , but this relationship seems to change over time .


Hematologic reference values vary by ethnicity .


We aimed to determine reference values of hemoglobin ( Hb ) for Korean adolescents .


Using data from the @th Korean National Health and Nutrition Examination Survey ( KNHANES ) , we obtained reference values for Hb in adolescents aged @-@ years .


Among @,@ subjects recruited , @ were excluded due to chronic diseases ( @ congenital heart disease , @ epilepsy , and @ thyroid disease ) or abnormal laboratory values ( @ subjects with Fe/TIBC < @ % , @ subjects with MCV < @fl ) .


Accordingly , data from @,@ subjects ( male = @,@ and female = @,@ ) were analyzed and age - and gender-stratified means and percentile values of Hb were obtained .


Pertinent findings observed in the current study were : ( i ) Hb levels in Korean male were similar to those of non-Hispanic Caucasians ; ( ii ) Hb values in females were similar to those of non-Hispanic Caucasians until age of @ , and thereafter were slightly lower .


Prevalence of anemia according to WHO criteria and our own criteria ( Hb levels < @ standard deviations of age - and gender-specific values ) in total sample was @ % ( @/@ ,@ ) and @ % ( @/@ ,@ ) , respectively .


Anemia was more prevalent in female in comparison with male ( @ % vs. @ % , P < @ ) .


Our results could be used as a national reference standard to correctly classify a large population sample .


Further studies are necessary to determine reference Hb values for children younger than @ years and identify genetic variations associated with distinctive characteristics observed in this study .


Most tobacco smokers who wish to quit fail to reach their goal .


One important , insufficiently emphasized aspect of addiction relates to the decision-making system , often characterized by dysfunctional cognitive control and a powerful drive for reward .


Recent proof-of-principle studies indicate that transcranial direct current stimulation ( tDCS ) over the dorsolateral prefrontal cortex ( DLPFC ) can transiently modulate processes involved in decision-making , and reduce substance intake and craving for various addictions .


We previously proposed that this beneficial effect of stimulation for reducing addictive behaviors is in part mediated by more reflective decision-making .


The goal of this study was to test whether nicotine intake and decision-making behaviors are modulated by tDCS over the DLPFC in tobacco smokers who wished to quit smoking .


Subjects received two five-day tDCS regimens ( active or sham ) .


Stimulation was delivered over the right DLPFC at a @ mA during @ min .


Nicotine cravings , cigarette consumption and decision-making were assessed before and after each session .


Main findings include a significant decrease in the number of cigarettes smoked when participants received active as compared to sham stimulation .


This effect lasted up to four days after the end of the stimulation regimen .


In regards to decision-making , smokers rejected more often offers of cigarettes , but not offers of money , after they received active as compared to sham stimulation at the Ultimatum Game .


No significant change was observed at the Risk Task with cigarettes or money as rewards .


Overall , these findings suggest that tDCS over the DLPFC may be beneficial for smoking reduction and induce reward sensitive effects .


Previous studies showed that noncoplanar intensity-modulated radiotherapy ( NC-IMRT ) for sinonasal cancer is superior to coplanar intensity-modulated radiotherapy ( IMRT ) .


Volumetric-modulated arc therapy ( VMAT ) is a newly introduced treatment modality , and the performance of noncoplanar VMAT for sinonasal cancer has not been well described to date .


To compare the dosimetry difference of noncoplanar VMAT ( NC-VMAT ) , coplanar VMAT ( co-VMAT ) , and NC-IMRT for sinonasal cancer .


Ten postoperative patients with sinonasal cancer were randomly selected for planning with NC-VMAT , co-VMAT , and NC-IMRT .


Two planning target volumes ( PTVs ) were contoured representing high-risk and low-risk regions set to receive a median absorbed dose ( D@ % ) of @ Gy and @ Gy , respectively .


The homogeneity index ( HI ) , conformity index ( CI ) , dose-volume histograms ( DVHs ) , and delivery efficiency were all evaluated .


Both NC-VMAT and co-VMAT showed superior dose homogeneity and conformity in PTVs compared with NC-IMRT .


There was no significant difference between NC-VMAT and co-VMAT in PTV coverage .


Both VMAT plans provided a better protection for organs at risk ( OARs ) than NC-IMRT plans , and NC-VMAT showed a small improvement over co-VMAT in sparing of OARs .


For peripheral doses , the doses to breast , thyroid , and larynx in the NC-IMRT plans were significantly higher than those in both VMAT plans .


Compared to NC-VMAT , co-VMAT significantly reduced peripheral doses .


NC-VMAT and co-VMAT reduced the average delivery time by @ and @ % , respectively , in comparison with NC-IMRT .


No differences in delivery efficiency were observed between the two VMAT plans .


Compared to NC-VMAT , co-VMAT showed similar PTV coverage and comparable OAR sparing but significantly reduced peripheral doses and positioning uncertainty .


We propose to give priority to coplanar VMAT in the treatment of sinonasal cancer .


There are no current pharmacological therapies for the prevention or treatment of acute respiratory distress syndrome .


Early dysregulated inflammation likely plays a role in acute respiratory distress syndrome development and possibly acute respiratory distress syndrome outcomes .


p@ mitogen-activated protein kinase is central to the regulation of multiple inflammatory mediators implicated in acute organ dysfunction and is the target for a novel class of cytokine-suppressive anti-inflammatory drugs .


In preclinical models , p@ inhibitors reduce lung injury following pancreatitis and burn injury .


We conducted a phase IIa , randomized , double-blind , placebo-controlled , parallel-group study to evaluate the safety and tolerability of dilmapimod , a novel p@ mitogen-activated protein kinase inhibitor , in patients at risk for developing acute respiratory distress syndrome admitted with an Injury Severity Score more than @ , excluding head trauma .


Enrolled patients received @ - or @-hour IV dilmapimod infusions at different doses or placebo , daily for @ days , in four separate cohorts .


Multicenter randomized clinical trial of large , academic trauma centers .


Seventy-seven patients were enrolled .


Although adverse events were common in this critically ill population , dilmapimod was well tolerated , with no clinically relevant safety findings .


Pharmacokinetic models indicated that the higher dose of @mg given as continuous infusion over @ hours had the most favorable plasma concentration profile .


Likewise , measures of soluble inflammatory markers including interleukin-@ , C-reactive peptide , interleukin-@ , and soluble tumor necrosis factor receptor @ were most different between this dosing arm and placebo .


Although the study was not specifically designed with acute respiratory distress syndrome as an outcome , the number of patients who developed acute respiratory distress syndrome was small ( @/@ ) .


The novel p@ mitogen-activated protein kinase inhibitor dilmapimod appears well tolerated and may merit further evaluation for prevention of acute respiratory distress syndrome and other organ injury in larger clinical trials .


Furthermore , results of this early-phase trial may aid in design of future studies aimed at prevention of acute respiratory distress syndrome and other organ injury .


To compare the effectiveness of two procedures increasing the botulinum toxin type A effect for wrist and finger flexor spasticity after stroke .


A single-blind randomized trial .


Seventy patients with upper limb post-stroke spasticity .


Adults with wrist and finger flexor muscles spasticity after stroke were submitted to botulinum toxin type A therapy .


After the treatment , the subjects injected were randomly divided into two groups and submitted to adhesive taping ( Group A ) or daily muscle manual stretching , passive articular mobilization of wrist and fingers , and palmar splint ( Group B ) for @ days .


We measured spasticity with Modified Ashworth Scale , related disability with Disability Assessment Scale , and fingers position at rest .


The measurements were done at baseline , after two weeks , and after one month from the treatment session .


After two weeks , subjects in Group A reported a significantly greater decrease in spasticity scores ( Modified Ashworth Scale fingers : mean ( standard deviation ) @ vs. @ ; Modified Ashworth Scale wrist : @ @ vs. @ @ ) , and after one month in spasticity and disability scores ( Modified Ashworth Scale fingers : mean ( standard deviation ) @ @ vs. @ @ ; Modified Ashworth Scale wrist : @ @ vs. @ @ ; Disability Assessment Scale : @ @ vs. @ @ ) compared with Group B subjects .


Subjects in Group A reported also a significantly improved fingers position at rest compared with Group B subjects after two weeks ( @ @ vs. @ @ ) and one month ( @ @ vs. @ @ ) .


Adhesive taping of wrist and finger flexor muscles appeared to enhance the effect of botulinum toxin type A therapy more than daily manual muscle stretching combined with passive articular mobilization and palmar splint .


Research has shown that @h after breeding is a critical time during the uterine innate immune response , and the failure to respond appropriately will result in persistent breeding-induced endometritis .


This presents a potential opportunity to modulate the course of inflammation towards a timely resolution .


To evaluate the effects of immune modulation on endometrial mRNA expression of inflammatory genes in susceptible mares @h after breeding .


The hypothesis was that immune modulation alters endometrial cytokine expression in susceptible mares .


A randomised controlled study to evaluate the effects of mycobacterial cell wall extract and dexamethasone on endometrial gene expression after insemination in @ mares susceptible to persistent breeding-induced endometritis .


Six susceptible mares were selected based on their uterine inflammatory response to insemination .


Mares were inseminated during @ oestrous cycles with @ @ ( @ ) nonviable spermatozoa and @ ) no additional treatment ( control ) , or in combination with @ ) dexamethasone ( @mg i.v. ) at the time of insemination , or @ ) with mycobacterial cell wall extract ( @ ml i.v. ) administered @h prior to insemination .


Mares received one treatment per cycle in randomised order , and each mare served as her own control .


Endometrial biopsies were collected @h after breeding , and quantitative polymerase chain reaction analysis for interleukin ( IL ) @ , IL@ , interferon , IL@ and IL@RA was performed .


Relative quantification values reported fold changes in mRNA expression from the control .


Data were analysed using an ANOVA and significance was set at P < @ .


Expression of IL@ mRNA was lower after treatment with dexamethasone ( P < @ ) and mycobacterial cell wall extract ( P < @ ) when compared with control .


No differences were detected in the mRNA expression of the other cytokines after any of the treatments .


Treatment with immune modulators alters endometrial mRNA expression of IL@ after insemination .


A better understanding of the mechanisms of immune modulation in the equine uterus can help to improve treatments for persistent breeding-induced endometritis .


Total knee arthroplasty ( TKA ) is often associated with severe pain .


Different regional anesthetic techniques exist , all with varying degrees of motor blockade .


We hypothesized that pain relief provided by the adductor canal block ( ACB ) could increase functional muscle strength .


We included @ TKA patients with severe movement-related pain ; defined as having visual analog scale pain score of greater than @ mm during active flexion of the knee .


The ACB group received an ACB with ropivacaine @ % @ mL and a femoral nerve block ( FNB ) with @ mL saline .


The FNB group received an ACB with @ mL saline and an FNB with ropivacaine @ % @ mL .


We compared the effect of the ACB versus FNB on maximum voluntary isometric contraction of the quadriceps muscle relative to a postoperative baseline value .


Secondary end points were differences between groups in ability to ambulate and changes in pain scores ( Clinicaltrials.gov identifier NCT@ ) .


After block , the quadriceps maximum voluntary isometric contraction increased to @ % ( @ % confidence interval -LSB- CI -RSB- , @-@ ) of the baseline value in the ACB group and decreased to @ % ( @ % CI , @-@ ) in the FNB group with an estimated difference of @ % ( @ % CI , @-@ ) , P < @ .


Pain scores were similar between groups .


Before block , @ of @ patients in each group were unable to perform the Timed-Up-and-Go test ; after block , this number increased to @ of @ in the FNB group and decreased to @ of @ in the ACB group .


Adductor canal block provides a clinically relevant and statistically significant increase in quadriceps muscle strength for patients in severe pain after TKA .


To make a comprehensive evaluation of the efficiency of eradication therapy in patients with coronary heart disease ( CHD ) concurrent with peptic ulcer disease ( PUD ) .


The results of treatment were studied in @ patients with CHD concurrent with PUD who were randomized into @ groups : @ ) adequate eradication therapy during treatment for CHD ; @ ) antisecretory therapy ; @ ) treatment for CHD only .


The trend in the clinical symptoms of the diseases and the results of an exercise test were assessed .


After eradication therapy , Group @ patients displayed a reduction in the frequency of angina attacks by @ % and weekly nitroglycerin needs by @ % and an increase in exercise tolerance by @ % .


In Group @ patients on antisecretory therapy , the similar indicators changed by @ , @ , and @ % , respectively .


Group @ patients showed no significant change in the study indicators .


The findings suggest that eradication therapy has a positive impact on the course of CHD , which manifests itself as an antianginal effect and hence a change in the clinical picture .


This paper examines the relationship between race , religiousness , spiritual well-being , antitumor treatment and preference for aggressive care among Black and White patients with advanced stage lung cancer receiving ambulatory cancer care in an urban setting .


A cross-sectional exploration of patients enrolled in a Cleveland-based longitudinal study after initial diagnosis of advanced lung cancer were interviewed in Cleveland regarding religiousness , spiritual well-being , preferences for cardiopulmonary resuscitation ( CPR ) , goals of aggressive care , and willingness to tolerate adverse health states .


Receipt of antitumor treatment was identified from medical records .


We analyzed data from @ Black and @ White patients ( N = @ ) .


Regression analysis for CPR showed that race was not associated with preference for CPR ( OR = @ , CI @-@ @ ) .


The odds of choosing CPR were three times higher among patients receiving antitumor treatment ( OR = @ , CI @-@ @ ) .


Greater willingness to endure adverse health states was associated with higher spiritual well-being scores ( b = @ , CI @-@ @ ) .


Choosing goals to extend life versus relieve pain was higher among persons with higher spiritual well-being as well ( RRR = @ , CI @-@ @ ) , yet the relationship with religiousness was negative ( RRR = @ , CI @-@ @ ) .


After controlling for multiple factors , race was associated only with CPR , but not with other measures of preference for aggressive care .


In addition , receipt of active antitumor treatment was positively associated with preference for CPR and spiritual well-being was important to setting end-of-life care goals and perspectives .


Future directions for tailoring end-of-life care decision-making initiatives should move beyond race and discussions of CPR alone and focus on a full spectrum of patient beliefs and preferences at the end of life .


Continuous intraperitoneal insulin infusion ( CIPII ) with an implantable pump is a treatment option for patients with type @ diabetes mellitus ( T@DM ) .


Aim of the present study was to describe the long-term course of glycaemic control , complications , health related quality of life ( HRQOL ) and treatment satisfaction among T@DM patients treated with CIPII .


Nineteen patients that participated in a randomized cross-over trial comparing CIPII and subcutaneous ( SC ) therapy in @ were followed until @ .


Laboratory , continuous glucose monitoring , HRQOL and treatment satisfaction measurements were performed at the start of the study , the end of the SC - , the end of the CIPII treatment phase in @ and during CIPII therapy in @ .


Linear mixed models were used to calculate estimated values and to test differences between the moments in time .


In @ , more time was spent in hyperglycaemia than after the CIPII treatment phase in @ : @ % ( @ % CI @ , @ ) vs. @ % ( @ % CI @ , @ ) , mean difference @ % ( @ % CI @ , @ ) .


HbA@c was @mmol/mol ( @ % CI @ , @ ) at the end of the SC treatment phase in @ , @mmol/mol ( @ % CI @ , @ ) at the end of the CIPII treatment phase and @mmol/mol ( @ % CI @ , @ ) in @ , respectively ( p > @ ) .


In @ , the median number of grade @ hypoglycaemic events per week ( @ ( @ % CI @ , @ ) ) was still significantly lower than during prior SC therapy ( @ ( @ % CI @ , @ ) ) : mean change -@ ( @ % CI -@ , -@ ) .


Treatment satisfaction with CIPII was better than with SC insulin therapy and HRQOL remained stable .


Pump or catheter dysfunction of the necessitated re-operation in @ patients .


No mortality was reported .


After @years of CIPII treatment , glycaemic regulation is stable and the number of hypoglycaemic events decreased compared to SC insulin therapy .


Treatment satisfaction with CIPII is superior to SC insulin therapy , HRQOL is stable and complications are scarce .


CIPII is a safe and effective treatment option for selected patients with T@DM , also on longer term .


Atelectasis is common during and after general anaesthesia .


We hypothesized that a ventilation strategy , without recruitment manoeuvres , using a combination of continuous positive airway pressure ( CPAP ) or positive end-expiratory pressure ( PEEP ) and a reduced end-expiratory oxygen fraction ( FETO@ ) before ending mask ventilation with CPAP after extubation would reduce the area of postoperative atelectasis .


Thirty patients were randomized into three groups .


During induction and emergence , inspiratory oxygen fractions ( FIO@ ) were @ in the control group and @ or @ in the intervention groups .


No CPAP/PEEP was used in the control group , whereas CPAP/PEEP of @ cmH@O was used in the intervention groups .


After extubation , FIO@ was set to @ in the intervention groups and CPAP was applied , aiming at FETO@ < @ .


Atelectasis was studied by computed tomography @ min postoperatively .


The median area of atelectasis was @ cm ( @ ) ( range @-@ @ cm ( @ ) ) and @ cm ( @ ) ( @-@ @ cm ( @ ) ) in the groups given FIO@ @ with or without CPAP/PEEP , respectively .


After correction for body mass index the difference between medians ( @ cm ( @ ) ) was statistically significant ( confidence interval @-@ @ cm ( @ ) , p = @ ) .


In the group given FIO@ @ , in which seven patients were ex - or current smokers , the median area of atelectasis was @ cm ( @ ) ( @-@ @ cm ( @ ) ) .


Compared with conventional ventilation , after correction for obesity , this ventilation strategy reduced the area of postoperative atelectasis in one of the intervention groups but not in the other group , which included a higher proportion of smokers .


Androgen deprivation therapy ( ADT ) is a cornerstone in the treatment of advanced prostate cancer .


Adverse musculoskeletal and cardiovascular effects of ADT are widely reported and investigations into the potential of exercise to ameliorate the effects of treatment are warranted .


The ` Football Club ( FC ) Prostate ' study is a randomized trial comparing the effects of soccer training with standard treatment approaches on body composition , cardiovascular function , physical function parameters , glucose tolerance , bone health , and patient-reported outcomes in men undergoing ADT for prostate cancer .


Using a single-center randomized controlled design , @ men with histologically confirmed locally advanced or disseminated prostate cancer undergoing ADT for @months or more at The Copenhagen University Hospital will be enrolled on this trial .


After baseline assessments eligible participants will be randomly assigned to a soccer training group or a control group receiving usual care .


The soccer intervention will consist of @weeks of training @-@ times/week for @-@min after which the assessment protocol will be repeated .


Soccer training will then continue bi-weekly for an additional @weeks at the end of which all measures will be repeated to allow for additional analyses of long-term effects .


The primary endpoint is changes in lean body mass from baseline to @weeks assessed by dual X-ray absorptiometry scan .


Secondary endpoints include changes of cardiovascular , metabolic , and physical function parameters , as well as markers of bone metabolism and patient-reported outcomes .


The FC Prostate trial will assess the safety and efficacy of a novel soccer-training approach to cancer rehabilitation on a number of clinically important health outcomes in men with advanced prostate cancer during ADT .


The results may pave the way for innovative , community-based interventions in the approach to treating prostate cancer .


Thiazolidinediones reduce ectopic fat , increase adiponectin and reduce inflammatory adipokines , fatty acids and glucose in people with Type @ diabetes .


We aimed to measure these effects in people with impaired fasting glucose and/or impaired glucose tolerance .


After approximately @ years of exposure to rosiglitazone @ mg ( n = @ ) or placebo ( n = @ ) , @ DREAM trial participants underwent abdominal computed tomography and dual-energy X-ray absorptiometry scans .


Visceral and subcutaneous adipose tissue areas , estimated hepatic fat content , total fat and lean mass were calculated and changes in levels of fasting adipokines , free fatty acids , glucose and post-load glucose were assessed .


Compared with the placebo , participants on rosiglitazone had no difference in lean mass , had @ kg more body fat ( P < @ ) and @ cm ( @ ) more subcutaneous abdominal adipose tissue area ( P = @ ) .


Only after adjusting for total fat , participants on rosiglitazone had @ cm less visceral adipose tissue area ( P = @ ) and an @-unit higher liver : spleen attenuation ratio ( i.e. less hepatic fat ; P = @ ) than those on the placebo .


Adiponectin increased by @ g/ml with rosiglitazone and by @ g/ml with placebo ( P < @ ) .


Rosiglitazone 's effect on fat distribution was not independent of changes in adiponectin .


Rosiglitazone 's effects on fasting ( -@ mmol/l ; P = @ ) and @-h post-load glucose ( -@ mmol/l ; P = @ ) were not affected by adjustment for fat distribution or changes in adiponectin or free fatty acids .


In people with impaired fasting glucose/impaired glucose tolerance , rosiglitazone is associated with relatively less hepatic and visceral fat , increased subcutaneous fat and increased adiponectin levels .


These effects do not appear to explain the glucose-lowering effect of rosiglitazone .


The aim of this study was to compare the preperitoneal versus the preaponeurotic mesh positioning in open paraumbilical hernia repair .


During the period from January @ until July @ , @ adult patients were randomly assigned to two equal groups .


The patients in group A were treated by preperitoneal mesh repair and those in group B underwent preaponeurotic mesh repair .


Both groups were assessed and compared .


There were no significant differences between the two groups in the demographics , hernia characteristics , risk factors , type of anesthesia , American Society of Anesthesiologists score or the mean follow-up period .


The length of the operation was significantly shorter in group B than in group A ( P value = @ ) .


There were no significant differences in the early postoperative complications except for the development of a seroma , which developed only in group B ( P value = @ ) .


The postoperative pain was significantly lower in group A than in group B ( P value = @ ) .


The time of return to normal daily activities was significantly shorter in group A than in group B ( P value = @ ) .


The preperitoneal mesh placement during the repair of paraumbilical hernias is superior to the preaponeurotic placement , because it is associated with fewer complications , less pain and a shorter time of return to normal daily activities .


Subphenotypes have been identified within heterogeneous diseases such as asthma and breast cancer , with important therapeutic implications .


We assessed whether subphenotypes exist within acute respiratory distress syndrome ( ARDS ) , another heterogeneous disorder .


We used data from two ARDS randomised controlled trials ( ARMA trial and ALVEOLI trial ) , sponsored by the National Heart , Lung , and Blood Institute .


We applied latent class modelling to identify subphenotypes using clinical and biological data .


We modelled data from both studies independently .


We then tested the association of subphenotypes with clinical outcomes in both cohorts and with the response to positive end-expiratory pressure ( PEEP ) in the ALVEOLI cohort .


We analysed data for @ patients : @ in the ARMA cohort and @ in the ALVEOLI cohort .


Independent latent class models indicated that a two-class ( ie , two subphenotype ) model was the best fit for both cohorts .


In both cohorts , we identified a hyperinflammatory subphenotype ( phenotype @ ) that was characterised by higher plasma concentrations of inflammatory biomarkers , a higher prevalence of vasopressor use , lower serum bicarbonate concentrations , and a higher prevalence of sepsis than phenotype @ .


Participants in phenotype @ had higher mortality and fewer ventilator-free days and organ failure-free days in both cohorts than did those in phenotype @ ( p < @ for all ) .


In the ALVEOLI cohort , the effects of ventilation strategy ( high PEEP vs low PEEP ) on mortality , ventilator-free days and organ failure-free days differed by phenotype ( p = @ for mortality , p = @ for ventilator-free days , p = @ for organ-failure-free days ) .


We have identified two subphenotypes within ARDS , one of which is categorised by more severe inflammation , shock , and metabolic acidosis and by worse clinical outcomes .


Response to treatment in a randomised trial of PEEP strategies differed on the basis of subphenotype .


Identification of ARDS subphenotypes might be useful in selecting patients for future clinical trials .


Influenza is an important cause of morbidity and mortality worldwide .


Treatment options are scarce , and new drugs with novel mechanisms of action are needed .


We aimed to assess the efficacy and safety of nitazoxanide , a thiazolide anti-infective , for treatment of acute uncomplicated influenza .


We did a double-blind , randomised , placebo-controlled , phase @b/@ trial in @ primary care clinics in the USA between Dec @ , @ , and April @ , @ .


We enrolled participants aged @-@ years with fever , at least one respiratory symptom , and one constitutional symptom of influenza within @ h of symptom onset .


We randomly assigned participants to receive either nitazoxanide @ mg , nitazoxanide @ mg , or placebo twice daily for @ days , ( ratio @:@:@ ) and followed them up for @ days .


Randomisation lists were computer generated and done in blocks of three .


Sponsor , investigators , study monitors , patients , and laboratory personnel were all masked to treatment allocation in the study .


The primary endpoint was the time from first dose to alleviation of symptoms .


The primary analysis was by intention-to-treat for participants with influenza infection confirmed by RT-PCR or culture at baseline .


This trial is registered with ClinicalTrials.gov , number NCT@ .


Of @ participants screened , @ ( @ % ) were enrolled .


Of these , @ were randomly assigned to receive placebo twice a day , @ to receive nitazoxanide @ mg twice a day , and @ to receive nitazoxanide @ mg a day .


The median duration of symptoms for participants receiving placebo was @ h ( @ % CI @-@ ) compared with @ h ( @-@ ; p = @ ) for those receiving @ mg nitazoxanide and @ h ( @-@ , p = @ ) for those receiving @ mg nitazoxanide .


Adverse events were similar between the three groups , the most common being headache reported by @ ( @ % ) of @ patients enrolled in placebo group , @ ( @ % ) of @ patients in the low-dose group , and @ ( @ % ) of @ patients in the high-dose group , or diarrhoea , reported by seven ( @ % ) patients in the placebo group , four ( @ % ) patients enrolled in the low-dose group , and @ ( @ % ) patients in the high-dose group .


Treatment with nitazoxanide @ mg twice daily for @ days was associated with a reduction of the duration of symptoms in participants with acute uncomplicated influenza .


Further studies are warranted to confirm these findings and to assess efficacy of the drug alone or in combination with existing drugs in seriously ill patients and those at risk of influenza complications .


The effects on plaque parameters of sugar free chewing-gums ( CG ) sweetened with either maltitol or xylitol were assessed to better understand the role polyols can play in dental caries prevention .


A double-blind , parallel , randomised , controlled study was conducted in China .


Subjects ( N = @ , age = @ to @ years-old ) were divided into @ groups : @ receiving polyols CG , containing respectively maltitol or xylitol , a group receiving gum base ( placebo ) and a negative control group not receiving any gum .


CG were chewed for @ days .


This corresponds to a @ g consumption of polyol per day .


Plaque parameters ( growth , pH , bacteria and insoluble glucans ) were evaluated throughout the experimental period .


All parameters studied were significantly modified with gum base compared to no-gum : plaque pH increased ; plaque growth , bacteria ( S. mutans , S. sobrinus , A. viscosus and Lactobacillus ) and insoluble glucans decreased .


Maltitol and xylitol CG led similarly to a higher plaque pH ( AUC , p@ @ ) on short ( at baseline after the first CG consumption ) and long term ( after @ weeks of daily CG consumption ) , with or without saliva stimulation compared to both control and placebo groups .


They led to a decrease in plaque growth ( p = @ ) over the experimental period compared to controls .


Moreover , they significantly reduced the concentration of @ cariogenic bacteria species ( p@ @ ) in dental plaque compared to gum base .


Sugar free CG sweetened with either maltitol or xylitol can similarly reduce plaque acidogenicity compared to gum base through a decrease in oral bacteria presence .


The use of a gum base placebo allowed to isolate effects on parameters involved in dental caries development specific to maltitol and xylitol , and to show these effects were similar .


The prevalence of non-alcoholic fatty liver disease is increasing worldwide and an effective and safe pharmacological treatment is needed .


We investigated whether inhibition of @-hydroxysteroid dehydrogenase type @ ( @-HSD@ , also known as HSD@B@ ) by RO@ could safely and effectively decrease liver-fat content in patients with this disorder .


We did this phase @b trial at four centres in Germany and Austria .


Participants with non-alcoholic fatty liver disease ( defined as ( @ ) H magnetic resonance spectroscopy liver-fat content > @ % ) , insulin resistance ( homoeostatic model assessment of insulin resistance -LSB- HOMA-IR -RSB- of at least @ mmol/LmU/L ) , BMI greater than @ kg/m ( @ ) , and aged @-@ years were randomly assigned by interactive voice response system in a @:@ ratio , stratified for triglyceride concentration ( < @ mmol/L or @ mmol/L ) , to oral RO@ ( @ mg twice daily ) or matching placebo for @ weeks .


The main exclusion criteria were other liver diseases , aspartate aminotransferase or alanine aminotransferase concentrations of more than two and a half times the upper limit of normal , history of diabetes or bariatric surgery , and use of weight lowering drugs .


Participants and investigators were masked to assignment throughout the study .


The primary endpoint was change in liver-fat content from baseline to week @ .


Efficacy analysis was by modified intention to treat , including all patients who received at least one dose of study drug and had a baseline and follow-up measurement of liver-fat content .


Safety analyses included all patients who received at least one dose of study drug .


This trial is registered with ClinicalTrials.gov , number NCT@ .


We did this trial between Jan @ , @ , and March @ , @ patients were randomly assigned to RO@ and @ to placebo .


@ patients in the RO@ group and @ in the placebo group were included in the efficacy analysis .


Mean liver-fat content decreased in the RO@ group ( from @ % -LSB- SD @ -RSB- to @ % -LSB- @ -RSB- ) , but not in the placebo group ( from @ % -LSB- @ -RSB- to @ % -LSB- @ -RSB- , p = @ for between group difference ) .


@ participants ( @ % ) in the RO@ group had adverse events , compared with @ ( @ % ) in the placebo group .


The most common adverse events were gastrointestinal disorders ( @ patients -LSB- @ % -RSB- in the RO@ group vs seven -LSB- @ % -RSB- in the placebo group ) , and infections and infestations ( eight -LSB- @ % -RSB- vs nine -LSB- @ % -RSB- ) .


Nervous system disorders occurred in significantly more patients in the RO@ group than in the placebo group ( nine -LSB- @ % -RSB- vs two -LSB- @ % -RSB- ; p = @ ) ; all other differences in adverse events were non-significant .


One participant ( @ % ) in the placebo group and three participants ( @ % ) in the RO@ group had serious adverse events .


All serious adverse events were deemed unrelated to study treatment .


Inhibition of @-HSD@ by RO@ was effective and safe in reducing liver-fat content , suggesting that targeting of @-HSD@ might be a promising approach for the treatment of non-alcoholic fatty liver disease .


Bone marrow mononuclear cell ( BMMC ) transplantation for heart failure has shown inconsistent therapeutic efficacy .


We enrolled @ ischemic heart failure patients scheduled for coronary artery bypass surgery ( CABG ) .


After @ - to @-week pharmacotherapy optimization , @ patients with left ventricular ejection fraction ( LVEF ) of @ % received injections of BMMC or vehicle intra-operatively into the myocardial infarction border area in a randomized , double-blind manner .


The median number of cells injected was @ @ ( @ ) ( interquartile range -LSB- IQR -RSB- : @ @ ( @ ) to @ @ ( @ ) ) .


We measured LV function and myocardial scar size by magnetic resonance imaging ( MRI ) , and viability by positron emission tomography ( PET ) and single-photon emission computed tomography ( SPECT ) , pre-operatively and after @-year follow-up .


LVEF , the pre-defined primary end-point measure , improved by a median of @ % in the control group ( IQR @ to @ ) and by @ % in the BMMC group ( IQR -@ to @ ) ( p = @ ) .


Wall thickening in injected segments rose by a median of @ % among controls ( IQR -@ to @ ) and by @ % in the BMMC group ( IQR -@ to @ ) ( p = @ ) .


Changes in viability by PET and SPECT did not differ between groups .


Myocardial scar size by MRI in injected segments rose by a median of @ % among controls ( IQR -@ to @ ) , but fell by @ % in the BMMC group ( IQR -@ to -@ ) ( p = @ ) .


BMMC therapy combined with CABG failed to improve LV systolic function , or viability , despite reducing myocardial scar size .


To assess the efficacy of moxibustion ( heating of the acupuncture needle with an igniting charcoal moxa stick ) with acupuncture for version of breech presentations after @@/@ weeks of gestation to reduce their rate at @ weeks of gestation and at delivery .


This was a randomized placebo-controlled single-blind trial including @ pregnant women recruited in a university hospital center between @@/@ and @@/@ weeks of gestation .


Moxibustion with acupuncture or inactivated laser ( placebo ) treatment was applied to point BL @ for six sessions .


The principal endpoint was the percentage of fetuses in breech presentation at @@/@ weeks of gestation .


The study included @ women randomized into two groups : moxibustion with acupuncture ( n = @ ) or placebo ( n = @ ) .


The percentage of fetuses in breech presentation at @@/@ weeks of gestation was not significantly different in both groups ( @ in the moxibustion with acupuncture group compared with @ % in the placebo group , relative risk @ , @ % confidence interval @-@ @ , P = @ ) .


Treatment by moxibustion with acupuncture was not effective in correcting breech presentation in the third trimester of pregnancy .


To evaluate the effects of different dosing intervals on multiple-dose pharmacokinetics , and safety and tolerability of fentanyl pectin nasal spray ( FPNS ) .


This was an open-label study in healthy volunteers .


Five FPNS treatments ( @ @ g ; @ @ g at @ - , @ - , and @-hour intervals , and @ @ g consecutively ) were administered to the right nostril , with a @-day washout period .


Blood samples were collected at predose and up to @,@ minutes postdose .


Plasma fentanyl concentrations were determined .


Pharmacokinetic parameters-peak concentration ( C ( max ) ) , time to C ( max ) ( t ( max ) ) , and area under the concentration-time curve ( AUC ) - were derived using noncompartmental method .


For the two-dose regimens , pharmacokinetic parameters were compared between doses using a paired t-test with p < @ as statistically significant .


Thirteen subjects were enrolled and @ completed the study .


Median tmax was @-@ minutes across five regimens .


Cmax post the second dose significantly increased for @-hour ( p < @ ) and @-hour ( p < @ ) but not @-hour intervals ( p = @ ) .


C ( max ) and AUC ( @-@ ) following @ @ g were approximately fivefold of those following @ @ g. Dizziness ( @ percent ) and somnolence ( @ percent ) were most common adverse events ( AEs ) .


@ percent of patients discontinued due to AEs .


FPNS exhibited consistently rapid t ( max ) .


When intervals between two doses were shorter , the difference in C ( max ) between the first and second dose was larger .


All regimens of FPNS were well tolerated .


Exposure reached a plateau after eight consecutive doses , suggesting potential limited absorption through the nasal mucosa .


Transcranial random noise stimulation ( tRNS ) is an innovative technique of non-invasive electrical stimulation .


tRNS over the parietal cortex has improved cognitive function in healthy controls and , applied to the auditory cortex , tRNS has shown beneficial effects on tinnitus .


Here we aimed to investigate the effects of tRNS over the auditory cortex on resting state and evoked activity in healthy subjects .


We used EEG to measure tRNS induced changes in resting state activity and in auditory steady state responses ( ASSRs ) .


Stimuli were @ Hz carrier frequency tones , amplitude modulated at @ Hz and @ Hz and applied in randomized order .


Fourteen subjects participated in a placebo-controlled randomized design study ; each received @ min of tRNS applied over auditory cortices with @ mA , with a one week interval between real and sham stimulation .


We found a significant increase in the ASSR in response to @ Hz frequency modulated tone and a non-significant trend toward an increase in mean theta band power and variability of the theta band power for the resting state data .


Our finding of tRNS induced increased excitability in the auditory cortex parallels previous findings of tRNS effects on motor cortex excitability and is in line with current concepts of tRNS mechanisms such as increase of stochastic resonance .


The purpose of this study was assess the effect of evolocumab ( AMG @ ) on lipoprotein ( Lp ) ( a ) from a pooled analysis of @ phase II trials .


Lp ( a ) , a low-density lipoprotein ( LDL ) particle linked to the plasminogen-like glycoprotein apolipoprotein ( a ) , shows a consistent and independent positive association with cardiovascular disease risk in epidemiological studies .


Current therapeutic options to reduce Lp ( a ) are limited .


A pooled analysis of data from @,@ patients in @ phase II trials assessed the effects of evolocumab , a fully human monoclonal antibody to PCSK@ , on Lp ( a ) , the relationship between Lp ( a ) and lowering of low-density lipoprotein cholesterol ( LDL-C ) and apolipoprotein B , and the influence of background statin therapy .


Lp ( a ) was measured using a standardized isoform-independent method .


Evolocumab treatment for @ weeks resulted in significant ( p < @ ) mean ( @ % confidence interval ) dose-related reductions in Lp ( a ) compared to control : @ % ( @ % to @ % ) and @ % ( @ % to @ % ) with @ mg and @ mg , dosed every @ and @ weeks , respectively , with no plateau of effect .


Lp ( a ) reductions were significantly correlated with percentages of reductions in LDL-C ( Spearman correlation coefficient , @ ; p < @ ) and apolipoprotein B ( Spearman correlation coefficient , @ ; p < @ ) .


Mean percentage reductions did not differ based on age or sex but the trend was greater in those patients taking statins .


Inhibition of PCSK@ with evolocumab resulted in significant dose-related reductions in Lp ( a ) .


While the mean percentage of reduction was significantly greater in those patients with baseline Lp ( a ) of @ nmol/l , the absolute reduction was substantially larger in those with levels > @ nmol/l .


The aim of this study was to assess whether the combination of low frequency repetitive transcranial magnetic stimulation ( rTMS ) and venlafaxine ( @-@ mg/day ) is effective and safe for treatment-resistant unipolar depression ( TRD ) .


In a multicenter ( @ centers ) randomized double blind controlled trial with three arms , @ patients were allocated to receive active rTMS combined with active venlafaxine ( n = @ ) , active rTMS combined with placebo venlafaxine ( n = @ ) or sham rTMS combined with active venlafaxine ( n = @ ) .


The patients received once daily sessions of active or sham @ Hz rTMS applied over the right dorsolateral prefrontal cortex ( @ pulses/day delivered at @ % of the resting motor threshold ) for two to six weeks ; rTMS was combined with active or sham venlafaxine ( mean dose : @ @ mg/day ) .


The primary outcome was the number of patients who achieved remission , which was defined as an HDRS@ score < @ .


We reported a similar significant antidepressant effect in the @ groups ( P < @ ( -@ ) ) , with a comparable delay of action and a comparable number of remitters at the endpoint ( @ % in the combination group , @ % in the rTMS group and @ % in the venlafaxine group ; P = @ ) .


Low frequency rTMS appears to be as effective as venlafaxine and as effective as the combination of both treatments for TRD .


Because of its short session duration ( the duration of one session was @ min ) and its safety , slow rTMS might be a useful alternative treatment for patients with TRD .


Several clinical trials have demonstrated the safety and effectiveness of oral tenofovir disoproxil fumarate ( TDF ) , with or without emtricitabine ( FTC ) , as pre-exposure prophylaxis ( PrEP ) for reducing the risk of HIV acquisition .


Adherence to the study product was insufficient to demonstrate the effectiveness of FTC/TDF in @ PrEP clinical trials conducted among women ( FEM-PrEP and the Vaginal and Oral Interventions to Control the Epidemic study ) , but further analyses of adherence in these studies may inform PrEP demonstration projects and future HIV prevention clinical trials .


We randomly selected a subcohort of @ participants randomized to FTC/TDF in @ FEM-PrEP sites ( Bondo , Kenya ; Bloemfontein , South Africa ; and Pretoria , South Africa ) to examine adherence levels over time and to assess factors associated with adherence , based on plasma tenofovir and intracellular tenofovir diphosphate drug concentrations in specimens collected at @-week visit intervals .


We observed drug concentrations consistent with good adherence in @ % of all visit intervals when drug was available to use , but only @ % of participants achieved good adherence throughout their study participation .


In multivariate analysis , the Bloemfontein site -LSB- odds ratio ( OR ) : @ ; @ % confidence interval ( CI ) : @ to @ -RSB- and liking the pill color ( OR : @ ; @ % CI : @ to @ ) were positively associated with good adherence , whereas using oral contraceptive pills at enrollment was negatively associated with good adherence ( OR : @ ; @ % CI : @ to @ ) .


Most participants did not regularly adhere to the study product throughout their trial participation , although a small minority did .


Few factors associated with good adherence to the study product were identified in FEM-PrEP .


Randomized crossover laboratory study .


To determine the effects of ankle destabilization devices on surface electromyography ( sEMG ) measures of selected lower extremity muscles during functional exercises in participants with chronic ankle instability .


Ankle destabilization devices are rehabilitation tools that can be worn as a boot or sandal to increase lower extremity muscle activation during walking in healthy individuals .


However , they have not been tested in a population with pathology .


Fifteen adults with chronic ankle instability participated .


Surface electromyography electrodes were located over the anterior tibialis , fibularis longus , lateral gastrocnemius , rectus femoris , biceps femoris , and gluteus medius .


The activity level of these muscles was recorded in a single testing session during unipedal stance with eyes closed , the Star Excursion Balance Test , lateral hops , and treadmill walking .


Each task was performed under @ conditions : shod , ankle destabilization boot , and ankle destabilization sandal .


Surface electromyography signal amplitudes were measured for each muscle during each exercise for all @ conditions .


Participants demonstrated a significant increase , with moderate to large effect sizes , in sEMG signal amplitude of the fibularis longus in the ankle destabilization boot and ankle destabilization sandal conditions during the unipedal eyes-closed balance test , the Star Excursion Balance Test in the anterior and posteromedial directions , lateral hops , and walking , when compared to the shod condition .


Both devices also resulted in an increase in sEMG signal amplitudes , with large effect sizes of the lateral gastrocnemius , rectus femoris , biceps femoris , and gluteus medius during the unipedal-stance-with-eyes-closed test , compared to the shod condition .


Wearing ankle destabilization devices caused greater muscle activation during functional exercises in individuals with chronic ankle instability .


Based on the magnitude of the effect , there were consistent increases in fibularis longus sEMG amplitudes during the unipedal eyes-closed balance test , the Star Excursion Balance Test in the anterior and posteromedial directions , and pre-initial contact and post-initial contact during lateral hops and walking .


Oxygen is commonly administered after extubation .


Although several devices are available , data about their clinical efficacy are scarce .


To compare the effects of the Venturi mask and the nasal high-flow ( NHF ) therapy on PaO@/FiO@SET ratio after extubation .


Secondary endpoints were to assess effects on patient discomfort , adverse events , and clinical outcomes .


Randomized , controlled , open-label trial on @ patients with a PaO@/FiO@ ratio less than or equal to @ immediately before extubation .


The Venturi mask ( n = @ ) or NHF ( n = @ ) were applied for @ hours postextubation .


PaO@/FiO@SET , patient discomfort caused by the interface and by symptoms of airways dryness ( on a @-point numerical rating scale ) , interface displacements , oxygen desaturations , need for ventilator support , and reintubation were assessed up to @ hours after extubation .


From the @th hour , PaO@/FiO@SET was higher with the NHF ( @ @ vs. @ @ at @ h ; P = @ ) .


Discomfort related both to the interface and to airways dryness was better with NHF ( respectively , @ @ vs. @ @ at @ h , P = @ ; @ @ vs. @ @ at @ h , P = @ ) .


Fewer patients had interface displacements ( @ % vs. @ % ; P = @ ) , oxygen desaturations ( @ % vs. @ % ; P < @ ) , required reintubation ( @ % vs. @ % ; P = @ ) , or any form of ventilator support ( @ % vs. @ % ; P < @ ) in the NHF group .


Compared with the Venturi mask , NHF results in better oxygenation for the same set FiO@ after extubation .


Use of NHF is associated with better comfort , fewer desaturations and interface displacements , and a lower reintubation rate .


Clinical trial registered with www.clinicaltrials.gov ( NCT @ ) .


To analysis the clinical characteristics of children with cough variation asthma ( CVA ) who received treatments with Carboxymethl starch sodium solution and inhaled Glucocorticoid budesonide .


A total of @ children with CVA were divided into two group randomly .


The control group ( n = @ ) received inhaled budesonide treatment ( @ microg/times in @-@ years old children , @ mg/times and @ times/day in @-@ years old children over a @ week period ) .


The children in treatment group ( n = @ ) were given carboxymethl starch sodium solution ( @ mL/times in @-@ years old children , @ mL/times in @-@ years old children , @ mL/times in @-@ years old children , @ times/day ) in addition to the inhaled budesonide treatment .


Observations were made on clinical therapeutic effects , cough score and the level of IgE @ weeks , @ weeks and @ weeks after the treatments , respectively .


Recurrence rate and adverse reactions were investigated .


Compared with the control group , the treatment group had significantly improved clinical characteristics after @ weeks and @ weeks of treatments ( P < @ ) , and reduced cough scores after @ weeks , @ weeks and @ weeks of treatments ( P < @ ) .


The IgE level of the children in the treatment group was significantly lower than the controls after @ weeks of treatments ( P < @ ) .


The treatment group also had significantly lower recurrence rate and adverse reactions than the controls ( P < @ ) .


Carboxymethl starch sodium solution can boost the clinical efficiency of inhaled budesonide in the treatment of children with cough variant asthma .


It is safe and effectual .


To determine any differences between the prevalence of adolescent idiopathic scoliosis in ballet dancers who are girls compared with age-matched nondancers , and to establish if any relations exist between the presence of scoliosis and generalized joint hypermobility , age of menarche , body mass index ( BMI ) , and the number of hours of dance training per week .


Cross-sectional , matched pair study .


Dance school .


Dancers ( n = @ ) between the ages of @ and @ years were recruited from a certified dance school in Western Australia ; each dancer provided a consenting age-matched nondancer ( n = @ ) .


Not applicable .


Measurements were taken for angle of trunk rotation using a scoliometer ( presence of scoliosis ) and for height and weight to produce generalized joint hypermobility using Beighton criteria and an age-adjusted BMI , respectively .


A subjective questionnaire regarding age of menarche and participation in dance and other sports was completed .


Thirty percent of dancers tested positive for scoliosis compared with @ % of nondancers .


Odds ratio calculations suggest that dancers were @ times more likely to have scoliosis than nondancers of the same age .


There was a higher rate of hypermobility in the dancer group ( @ % ) compared with the nondancers ( @ % ) ; however , there were no statistically significant relations between scoliosis and hypermobility , age of menarche , BMI , or hours of dance per week .


Adolescent dancers , similar to adult dancers , are at significantly higher risk of developing scoliosis than nondancers of the same age .


Vigilant screening and improved education of dance teachers and parents of dance students may be beneficial in earlier detection and , consequently , reducing the risk of requiring surgical intervention .


The aim of this study was to evaluate the effect of working length determination methods , electronic apex locator and digital radiography , on postoperative pain .


Two hundred twenty patients with asymptomatic single-rooted vital teeth were randomly assigned to @ groups according to the method used for working length determination , the radiographic group and the electronic apex locator group .


After working length determination , chemomechanical preparation was performed in a crown-down technique with ProTaper instruments .


A master cone radiograph was taken .


Canals were obturated with gutta-percha and sealer by using a lateral compaction technique .


Postoperative pain was assessed after @ , @ , @ , @ , and @hours by using a @-point pain intensity scale .


In addition , patients were asked to record the number of days necessary to achieve complete pain resolution .


Postoperative pain during the @-hour to @-hour interval studied was not significantly different ( P > @ ) between groups .


The mean times for pain dissipation in the radiographic and electronic apex locator groups were @ @ and @ @ days , respectively .


The difference between groups was not statistically significant ( P > @ ) .


There is no difference in postoperative pain between working length measurement methods by using an electronic apex locator or digital radiography .


The reduced exposure to radiation by using apex locator may be a factor that influences a dentist 's decision to choose the electronic apex locator over radiography .


Rehabilitation has been reported to improve pain and disability for patients after lumbar surgery .


However , studies to investigate the rehabilitation intervention for lumbar decompression surgery during hospitalization are scarce .


The aim of this study was to examine outcomes of perioperative rehabilitation intervention for patients who underwent lumbar decompression surgery ( LDS ) .


Patients aged @-@ years old who received their first LDS were randomized into the perioperative rehabilitation group ( PG ) or control group ( CG ) .


The PG received rehabilitation intervention during hospitalization for lumbar decompression surgery .


Pain , functional capacity , Roland-Morris Disability Questionnaire ( RMDQ ) , and Short-Form Health Survey ( SF-@ ) were assessed on admission , at discharge , and at follow-ups one month , three months , and six months after surgery .


Two-way repeated measures ANOVAs were used for statistical analysis .


A total of @ patients scheduled for decompression surgery for lumbar stenosis were enrolled into the study .


After surgery , the PG showed significant pain relief and improvement of disability as well as quality of life , but there were no significant functional improvements compared with the CG .


The findings of this study indicate that the rehabilitation intervention during hospitalization improves pain intensity as well as disability and quality of life , yet has limited effects on the functional performance over time up to six months post-surgery in patients who received LDS .


The study suggest that rehabilitation interventions during hospitalization must include regular support for patient adherence to the intervention program and focus on task-oriented programs for lower extremities such as closed-chain exercises in functional postures .


The @-HT@B / D agonists ( triptans ) are specific headache medications that have no effect on pain as such .


Although they are routinely used in the treatment of acute migraine attacks , the underlying mechanisms of action are still a matter of debate .


Forty-three healthy participants underwent fMRI while receiving trigemino-nociceptive stimulation and control stimuli in a standardized fMRI paradigm .


Using a crossover , double-blind , placebo-controlled design , @ participants ( @ women , mean age @ , range @-@ years ) received sumatriptan and @ participants ( @ women , mean age @ , range @-@ years ) received acetylsalicylic acid ( ASA ) .


Administration of medication and saline was randomized between participants of each group resulting in half of the participants receiving saline and the other half receiving the respective medication during the first fMRI data acquisition .


While mean pain intensity ratings did not differ significantly between control and medication nor between medications , we found a significant blood oxygen level-dependent signal increase in the trigeminal nuclei and the thalamus after sumatriptan treatment compared with placebo or ASA .


In addition , we specifically looked for the pharmacologic modulation of functional coupling between trigeminal nuclei and higher brain areas , i.e. , trigemino-cortical pathways , and found a strong coupling during the saline condition , which was altered by sumatriptan but not after ASA administration .


These data suggest that a specific functional inhibition of trigemino-cortical projections is one of the reasons that triptans , unlike pain killers , act highly specifically on headache and migraine but not pain as such .


To compare dilutional effect of distilled water with saline solution as an irrigation fluid in percutaneous nephrolithotomy ( PCNL ) .


Three hundred twenty eight adult patients ( @ men , @ women ) who were candidates for PCNL were randomly assigned into two groups ( distilled water , n = @ , group @ ; saline solution , n = @ , group @ ) .


Stone size , operation time , irrigation fluid volume , blood hemoglobin level , urea nitrogen , creatinine , sodium and potassium levels were checked before and at @ and @ hours after operation .


The mean age of the patients was @ years , and the mean stone diameter was @ mm .


There was no clinical case of transurethral resection ( TUR ) syndrome .


Serum sodium depletion was significantly more in group @ than group @ ( P < @ ) .


Group @ had significant decreased post-operative serum sodium levels ( P < @ ) .


Similarly in group @ , postoperative serum sodium levels were significantly lower than the preoperative concentration ( P < @ ) , but it was not the same @ hours after the operation ( P = @ ) .


Serum sodium concentrations remained within normal limits in all cases , without causing clinical signs and symptoms of hyponatremia .


We found that distilled water is safe irrigation fluid for PCNL in adults .


In addition , it is more available and cost effective .


To determine whether field photodynamic therapy ( PDT ) of actinic keratoses using a novel preparation of @-aminolevulonic acid ( novel ALA ) results in fewer subsequent invasive skin cancers developing on the face of individuals with previous facial cutaneous malignancy in a prospective randomized controlled trial .


Intervention patients received two treatments of novel ALA @ weeks apart .


Controls were observed .


Patients were followed up with biopsy of any suspicious lesions for @ years .


The trial was suspended early because of problems with trial governance and the reporting of severe adverse events .


Sixty-four patients who were recruited at that time at one center were monitored .


Their average age was @ , and @ % were male .


Patients were randomized to intervention ( n = @ ) or observation ( n = @ ) .


Over the subsequent @ years , @ intervention patients ( @ % ) developed @ new cutaneous malignancies in the field treated , and @ control patients ( @ % ) developed @ new malignancies .


Some intervention patients experienced prolonged adverse events , including permanent scarring .


Novel ALA made no difference in the likelihood of new malignancies developing .


The risks without benefit of this novel ALA are troubling .


Lack of efficacy and safety of novel ALA can not be extrapolated to other PDT products .


Nonmedical use of prescription opioids ( NM-POs ) has reached epidemic proportions in the United States .


Unintentional overdose deaths involving prescription opioids have quadrupled since @ .


Herein , we examine NM-POs and their associated risk factors among two cohorts of trauma patients with at-risk drinking .


This secondary analysis examines NM-PO from two separate randomized trials that delivered brief alcohol interventions to patients in urban Level I trauma centers .


In the first study , data were collected from @,@ injured patients at a single trauma center , and in the second study , data were collected from @ injured patients at two trauma centers .


All participants were considered at-risk drinkers because they were admitted for an alcohol related injury as indicated by a positive blood alcohol concentration and/or self-reported heavy drinking .


In Study @ , NM-PO nearly doubled from @ % before admission to @ % at @ months after discharge .


At @ months after discharge , those who reported NM-PO ( odds ratio -LSB- OR -RSB- , @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ) and drug use ( OR , @ , @ % CI , @-@ @ ) before admission had the highest odds for postdischarge NM-PO .


In Study @ , NM-PO increased from @ % before admission to @ % at @ months after discharge .


At @ months after discharge , those who reported NM-PO ( OR , @ ; @ % CI , @-@ @ ) or drug use ( OR , @ ; @ % CI , @-@ @ ) before admission had the highest odds for postdischarge NM-PO .


The results suggest that there is an increased risk of postdischarge NM-PO among injured patients with at-risk drinking , particularly among those with a recent history of drug use or NM-PO .


Cautious , evidence-based opioid prescribing may reduce exposure to prescription opioids in high-risk patients , risk of subsequent misuse , and possible diversion .


Prognostic/epidemiologic study , level II .


To investigate the efficacy and safety of repeated @-week courses of @ or @ mg daily of ulipristal acetate for intermittent treatment of symptomatic uterine fibroids .


Double-blind , randomized administration of two @-week courses of ulipristal acetate .


Gynecology centers .


A total of @ patients with symptomatic uterine fibroid ( s ) and heavy bleeding .


Two repeated @-week treatment courses of daily @ or @ mg of ulipristal acetate .


Amenorrhea , controlled bleeding , fibroid volume , quality of life ( QoL ) , pain .


In the @ - and @-mg treatment groups ( @ % and @ % of patients , respectively ) achieved amenorrhea during both treatment courses .


Proportions of patients achieving controlled bleeding during two treatment courses were > @ % .


Menstruation resumed after each treatment course and was diminished compared with baseline .


After the second treatment course , median reductions from baseline in fibroid volume were @ % and @ % for the patients receiving @ and @ mg of ulipristal acetate , respectively .


Pain and QoL improved in both groups .


Ulipristal acetate was well tolerated with less than @ % of patients discontinuing treatment due to adverse events .


Repeated @-week courses of daily oral ulipristal acetate ( @ and @ mg ) effectively control bleeding and pain , reduce fibroid volume , and restore QoL in patients with symptomatic fibroids .


The aim of this study is to assess the effectiveness of a very brief structured counseling for tobacco cessation in dentistry clinics .


A cluster randomized trial was conducted in Sweden in @-@ .


Twenty-seven dentistry clinics in two Swedish counties were randomized to provide either a structured brief advice based on the @ A 's model or usual care .


Participants were @ patients currently using tobacco daily ( @ in the intervention group and @ in usual care ) , of which @ % were retained at follow-up , six months after enrolment .


Study outcomes were : @-day abstinence ( primary outcome ) ; @-month sustained abstinence ; @ % reduction of the amount tobacco used ; quit attempts lasting at least @h .


Compared to usual care , brief counseling was not associated to statistically significant increase in the proportion abstinent from tobacco use after @months .


However , there was a statistically significant association with reduction of tobacco consumption ( OR = @ @ % CI @-@ @ ) .


Changes in the expected direction for all outcomes were more frequent in the intervention than in the usual care group , and larger among exclusive snus users than among smokers .


Very brief and structured counseling in dentistry may achieve positive behavioral modifications among tobacco users , with significant reduction of tobacco consumption , particularly among smokeless tobacco users .


To study whether high-dose versus usual-dose statin treatment reduces the incidence of peripheral artery disease ( PAD ) and what is the effect of high-dose statin treatment on cardiovascular disease ( CVD ) outcome in patients with PAD .


In the Incremental Decrease in End Points Through Aggressive Lipid Lowering trial , @ post-myocardial infarction patients were randomised to high-dose or usual-dose statin therapy ( atorvastatin @mg/day vs simvastatin @-@mg / day ) .


We investigated the effect of high-dose versus usual-dose statins on the pre-specified outcome PAD incidence , and additionally performed a posthoc analysis of the efficacy of high-dose statins in reducing CVD risk among patients with PAD .


During a median follow-up of @ years , @ patients ( @ % ) receiving atorvastatin and @ patients ( @ % ) receiving simvastatin developed PAD ( HR = @ , @ % CI @ to @ ; p = @ ) .


The risk of major coronary events was almost twofold higher in patients with PAD at baseline , but was no longer significant after adjusting for the adverse cardiovascular risk profile .


In PAD patients , major coronary events occurred in fewer patients in the atorvastatin group ( @ % ) than in the simvastatin group ( @ % ) , but the difference did not reach statistical significance .


( HR = @ , @ % CI @ to @ ; p = @ ) .


Atorvastatin treatment significantly reduced overall cardiovascular ( p = @ ) and coronary events ( p = @ ) , and coronary revascularisation ( p = @ ) in these patients .


High-dose statin therapy with atorvastatin significantly reduced the incidence of PAD compared with usual-dose statin therapy with simvastatin .


Patients with a history of PAD at baseline were at higher risk of future coronary events and this risk was reduced by high-dose atorvastatin treatment .


To evaluate the effect of tube current limitation on contrast enhancement , image quality , and radiation dose in whole-body @-detector CT with a high heat-capacity X-ray tube and automated tube current modulation .


One hundred eighteen patients were randomized into three whole-body CT protocols : tube current limitation at @ mA , @ mA , and no limitation .


Signal-to-noise ratio ( SNR ) , dose-length product ( DLP ) , estimated effective dose ( ED ) , and image quality were assessed .


Mean SNR of aorta was comparable among protocols , but that of liver was somewhat lower in @-mA than in @-mA and no-limitation protocols ( p < @ ) .


Mean DLP with @-mA ( @ mGy cm ) was reduced by @ % from that with @-mA ( @ mGy cm ) and by @ % from that with no-limitation protocol ( @ mGy cm ) , respectively .


Image quality was slightly degraded ( p < @ ) with @ mA relative to the others in thorax and pelvis , but no difference was found in diagnostic acceptability .


For whole-body CT using multidetector CT mounted with a high heat-capacity X-ray tube , an appropriate tube current limitation setting may help reduce excessive radiation dose without significant compromise in diagnostic acceptability .


To compare the efficacy and safety of long-term treatment ( @ weeks ) with tiotropium bromide ( @ g ) via Respimat ( ) with placebo in patients with chronic obstructive pulmonary disease ( COPD ) .


A total of @ patients were randomized in this double-blind , placebo controlled , parallel study .


All patients received either tiotropium bromide or placebo .


Tiotropium bromide solution @ g ( @ g/puff ) or matching placebo was delivered via Respimat ( ) at a dosage of once daily for @ weeks .


Co-primary endpoints were trough forced expiratory volume in one second ( FEV ( @ ) ) and the time to first exacerbation .


Statistically significant improvements of both trough FEV ( @ ) and trough forced vital capacity ( FVC ) in the tiotropium group were achieved at weeks @ , @ , and @ compared with those in the placebo group ( P < @ @ ) .


Tiotropium treatment delayed the time to first exacerbation .


The time was @ days in the tiotropium group and @ days in the placebo group .


A statistically significant difference ( P = @ @ ) in favor of tiotropium was also observed .


The total numbers of exacerbation during treatment were @ and @ in the tiotropium and placebo groups , respectively .


The Poisson regression analysis gave a mean exacerbation rate per patient year exposure of @ in the tiotropium group compared to @ in the placebo group with a rate ratio of @ ( @ % CI @-@ @ , P = @ @ ) .


A much larger improvement from baseline in St. George 's respiratory questionnaire ( SGRQ ) total score was observed for the tiotropium group than in the placebo group ( P = @ @ ) , SGRQ symptom and activity scores of patients in the tiotropium group were also superior to those of patients receiving placebo .


The drugs-related adverse events in the tiotropium and placebo groups were @ cases and @ cases , respectively .


Tiotropium significantly improved lung function and quality of life , delayed the time to first exacerbation , reduced the number of exacerbation .


Overall , tiotropium was well tolerated .


According to the International Association for the Study of Pain ( IASP ) , the term temporomandibular disorder ( TMD ) regards a subgroup of orofacial pain , the symptoms of which include pain or discomfort in the temporomandibular joint , ears , masticatory muscles and neck on one or both sides , as well as joint sounds , limited mandibular movements or mandibular deviation and difficulties chewing .


Phototherapy , such as low-level laser therapy ( LLLT ) and light-emitting diode ( LED ) therapy , is one of the resources used to treatment muscle pain .


Thus , there is a need to investigate therapeutic resources that combine different wavelengths as well as different light sources ( LLLT and LED ) in the same apparatus .


The aim of the proposed study is to evaluate the effects of four different doses of phototherapy on pain , activity of the masticatory muscles ( masseter and bilateral anterior temporal ) and joint mobility in individuals with temporomandibular disorder .


A further aim is to determine the cumulative effect @ and @ hours after a single session .


A placebo-controlled , double-blind , randomized , clinical trial will be carried out involving @ women between @ and @ years of age with a diagnosis of myogenous TMD .


The participants will then be randomly allocated to four groups totaling @ individuals per group .


Three groups will be submitted to a single session of phototherapy with different light sources , and one group will receive placebo therapy : Group A ( @ Joules ) ; Group B ( @ Joules ) ; Group C ( @ Joules ) ; and Group D ( @ Joules ) .


The following assessment tools will be administered on four separate occasions ( baseline and immediately after , @ h after and @ h after phototherapy ) .


Pain intensity will be assessed using the visual analog scale for pain , while pain thresholds will be determined using algometer , and electromyographic ( EMG ) analysis on the masseter and anterior temporal muscles .


The study will contribute to the practice of the evidence-based use of phototherapy in individuals with a myogenous TMD .


Data will be published after the study is completed .


Data relating to the impact of body mass index ( BMI ) on outcomes after isolated aortic valve replacement ( AVR ) are scarce and controversial .


The study aim was to investigate the predictive value of BMI for early and late mortality after isolated AVR .


Data obtained from patients who underwent isolated AVR between January @ and December @ at the authors ' institution were analyzed retrospectively .


Patients were allocated to five groups according to the preoperative BMI : underweight ( BMI < @ kg/m@ ) ; normal weight ( BMI @-@ @ kg/m@ ) ; overweight ( BMI @-@ @ kg/m@ ) ; obese ( BMI @-@ @ kg/m@ ) ; and morbidly obese ( BMI > @ kg/m@ ) .


Logistic and Cox regression analyses were performed to identify the independent predictors of early and late mortality , respectively .


After excluding @ patients who were lost to follow up , and @ patients with missing preoperative BMI data , a total of @,@ patients was included in the analysis .


The mean follow up was @ + / - @ years ( range : @-@ @ years ) , and the mean BMI @ + / - @ kg/m@ ( range : @-@ kg/m@ ) .


Multivariate logistic regression analyses showed no association between early mortality and the BMI groups .


Multivariate Cox regression analyses showed ` underweight ' to be an independent predictor for late mortality ( hazard ratio @ ; @ % confidence interval @-@ @ , p < @ ) .


` Underweight ' is an independent predictor for late mortality after AVR surgery .


Morbid obesity did not prove to be predictive of a worse late survival .


Patients with mild to moderate obstructive sleep apnoea ( OSA ) commonly suffer excessive daytime sleepiness .


Continuous positive airway pressure ( CPAP ) has limited effectiveness in reducing sleepiness in milder OSA .


Modafinil is a wake-promoting drug licensed to treat residual sleepiness in CPAP-treated OSA .


We hypothesised that modafinil may effectively treat sleepiness in untreated mild to moderate OSA .


Untreated sleepy men with mild to moderate OSA ( age @-@ , apnoea-hypopnoea index ( AHI ) @-@ / h , Epworth Sleepiness Scale ( ESS ) @ ) were randomised to receive @ mg modafinil or matching placebo daily for @ weeks before crossing over to the alternative treatment after a minimum @-week washout .


Mixed model analysis of variance was used to compare the changes on modafinil to placebo while classifying all randomised patients as random factors .


@ patients were randomised ( mean ( SD ) AHI @ ( @ ) / h , age @ ( @ ) years , ESS @ ( @ ) , body mass index @ ( @ ) kg/m ( @ ) ) , @ of whom ( @ % ) completed the trial .


The primary outcome ( ESS ) improved more on modafinil than placebo ( @ points , @ % CI @ to @ , p = @ ) and the secondary outcome ( @-min driving simulator performance ) also improved more on modafinil than placebo ( steering deviation @ cm , @ % CI @ to @ , p = @ ) .


Psychomotor Vigilance Task reciprocal reaction time improved significantly over placebo ( @ ( @/ms ) , @ % CI @ to @ , p = @ ) .


Improvements on the Functional Outcomes of Sleep Questionnaire were not significant ( @ points over placebo , @ % CI -@ to @ , p = @ ) .


Modafinil significantly improved subjective sleepiness in patients with untreated mild to moderate OSA .


The size of this effect is clinically relevant at @-@ ESS points of improvement compared with only @-@ points in CPAP clinical trials .


Driving simulator performance and reaction time also improved on modafinil .


This study investigated the effects of irrigation solutions , administered at either @ or @C in percutaneous nephrolithotomy ( PCNL ) , on hypothermia and related postoperative complications such as late emergence and late recovery from anesthesia , shivering , lactic acidosis , and excess bleeding .


Sixty patients who were scheduled for PCNL were enrolled in this prospective randomized double-blind study .


Irrigation solutions at room temperature were administered to patients in group R ( @ patients ) , and warmed irrigation solutions were administered to patients in group W ( @ patients ) .


The two groups were compared for core and peripheral body temperature , incidence of hypothermia , duration of emergence from anesthesia , duration of recovery from anesthesia , shivering , lactic acidosis , and hemoglobin levels .