Topical application of the BRB gel to OIN lesions resulted in statistically significant reductions in lesional sizes , histologic grades , and LOH events .


In contrast , placebo gel lesions demonstrated a significant increase in lesional size and no significant effects on histologic grade or LOH events .


Collectively , these data strongly support BRB 's chemopreventive impact .


A cohort of very BRB-responsive patients , as demonstrated by high therapeutic efficacy , was identified .


Corresponding protein profiling studies , which demonstrated higher pretreatment levels of BRB metabolic and keratinocyte differentiation enzymes in BRB-responsive lesions , reinforce the importance of local metabolism and differentiation competency .


Results from this trial substantiate the LOH reductions identified in the pilot BRB gel study and extend therapeutic effects to significant improvements in histologic grade and lesional size .


Unruptured intracranial aneurysm repair is the most commonly performed procedure for the prevention of hemorrhagic stroke .


Despite efforts to regionalize care in high-volume centers , overall results have improved little .


This study aims to determine the effectiveness in improving outcomes of previous efforts to regionalize unruptured intracranial aneurysm repair to high-volume centers and to recommend future steps toward that goal .


Using data obtained via the New York Statewide Planning and Research Cooperative System , this study included all patients admitted to any of the @ highest volume centers in New York state between @ and @ with a principal diagnosis of unruptured intracranial aneurysm who were treated either by microsurgical or endovascular repair .


Mixed-effects logistic regression was used to determine the degree to which hospital-level and patient-level variables contributed to observed variation in good outcome , defined as discharge to home , between hospitals .


Of @ patients treated during the study period , @ ( @ % ) were treated at the @ highest volume centers , with @ ( @ % ) experiencing a good outcome .


Good outcomes varied widely between centers , with @ % to @ % of clipped patients and @ % to @ % of coiled patients discharged home .


Mixed-effects logistic regression revealed that procedural volume accounts for @ % of the between-hospital variation in outcome .


There is notable interhospital heterogeneity in outcomes among even the largest volume unruptured intracranial aneurysm referral centers .


Although further regionalization may be needed , mandatory participation in prospective , adjudicated registries will be necessary to reliably identify factors associated with superior outcomes .


Addiction constitutes a major public health problem , and despite treatment , relapse rates remain very high .


Preliminary findings suggest that Eye Movement Desensitization and Reprocessing ( EMDR ) , an evidence-based treatment for PTSD , may also reduce craving and relapse rates when applied in substance abuse .


This study aims to determine the feasibility , efficacy and effectiveness of EMDR when added to treatment as usual ( TAU ) for addiction in alcohol dependent outpatients , compared to TAU only .


A single blinded study in which @ adult patients with a primary DSM-IV-TR diagnosis of alcohol dependence or abuse receiving treatment in one of six Dutch outpatient addiction care facility sites , will be enrolled .


After baseline assessment participants will be allocated to one of two treatment conditions ( allocation ratio of @:@ ) using a stratified ( per site , per care pathway ) , blocked randomization procedure .


The intervention consists of EMDR ( seven weekly @ minute sessions ) + TAU or TAU only .


Assessments are scheduled pre-treatment ( t@ ) , post-treatment ( t@ + eight weeks ) , and one and six months post treatment .


The effects of both treatment arms are compared on indices of ( a ) drinking behavior , ( b ) mediators , moderators and predictors of treatment outcome , ( c ) quality of life and d ) safety , acceptability and feasibility of treatment .


Repeated measures ANOVA 's will be conducted using an intention-to-treat and per-protocol approach .


Multiple imputation will be used to deal with missing values when possible .


This study adapts and extends the standard EMDR treatment for traumatized patients for use with patients with alcohol use disorders without psychological trauma .


Cytomegalovirus ( CMV ) infection involves interaction between endothelial cells and leukocyte subsets that may promote vascular inflammation and lead to treatment failure in infected individuals .


Osteoprotegerin is a marker of vascular and systemic inflammation but has not been investigated in relation to treatment outcome during CMV infection .


We investigated whether circulating levels of osteoprotegerin are related to features of CMV disease and treatment outcomes during CMV infection in @ solid organ transplant recipients receiving valganciclovir or ganciclovir in an international multicenter trial of CMV disease treatment ( the VICTOR study ) .


Elevated plasma osteoprotegerin was associated with ( i ) certain disease characteristics including presence of tissue invasive disease ( P < @ ) and increased viral load at baseline ( P < @ ) , ( ii ) poor virological outcome at day @ after anti-CMV therapy , ( iii ) increased plasma levels of markers of inflammation ( pentraxin @ and C-reactive protein ) and endothelial cell activation ( von Willebrand factor ) both at baseline and during follow-up .


Our finding indicates that elevated osteoprotegerin levels in solid organ transplant recipients with CMV infection may reflect vascular inflammation and is associated with late virological outcome in these patients .


To compare the efficacy of two mechanical devices for cervical ripening : double versus single balloon catheters , both with extra-amniotic saline infusion ( EASI ) .


Women at term with a singleton pregnancy presenting for labor induction were assigned to receive the double balloon catheter ( with EASI ) or the single balloon catheter ( with EASI ) .


Outcomes included time from device insertion to delivery , rates of successful vaginal delivery and occurrence of adverse events .


One hundred and eighty-six women completed the study .


Ripening success was comparable between the double and single balloon arms ( @ % versus @ % , p = @ , respectively ) .


Balloon insertion to delivery interval was significantly shorter , and cesarean section rate was significantly lower in the double balloon arm compared with the single balloon arm ( @ versus @ h , p = @ and @ % versus @ % , p = @ , respectively ) .


There were no significant differences in maternal characteristics , satisfaction or adverse outcomes .


This study is the first documented assessment of the double balloon catheter combined with EASI .


Our findings suggest that the double balloon catheter results in reduced time to delivery and higher vaginal delivery rates , compared with the single balloon catheter with EASI , without compromising maternal or fetal safety .


Across the United States , tens of thousands of college students are mandated to receive an alcohol intervention following an alcohol policy violation .


Telephone interventions may be an efficient method to provide mandated students with an intervention , especially when they are away from campus during summer vacation .


However , little is known about the utility of telephone-delivered brief motivational interventions .


Participants in the study ( N = @ ) were college students mandated to attend an alcohol program following a campus-based alcohol citation .


Participants were randomized to a brief motivational phone intervention ( pBMI ) ( n = @ ) or assessment only ( n = @ ) .


Ten participants ( @ % ) randomized to the pBMI did not complete the intervention .


Follow-up assessments were conducted @ , @ , and @ months post-intervention .


Results indicated the pBMI significantly reduced the number of alcohol-related problems compared to the assessment-only group .


Participants who did not complete the pBMI appeared to be lighter drinkers at baseline and randomization , suggesting the presence of alternate influences on alcohol-related problems .


Phone BMIs may be an efficient and cost-effective method to reduce harms associated with alcohol use by heavy-drinking mandated students during the summer months .


Epidemiologic and experimental data have suggested that chlorogenic acid , which is a polyphenol contained in green coffee beans , prevents diet-induced hepatic steatosis and insulin resistance .


We assessed whether the consumption of chlorogenic acid-rich coffee attenuates the effects of short-term fructose overfeeding , dietary conditions known to increase intrahepatocellular lipids ( IHCLs ) , and blood triglyceride concentrations and to decrease hepatic insulin sensitivity in healthy humans .


Effects of @ different coffees were assessed in @ healthy volunteers in a randomized , controlled , crossover trial .


IHCLs , hepatic glucose production ( HGP ) ( by @,@-d@ glucose dilution ) , and fasting lipid oxidation were measured after @ d of consumption of caffeinated coffee high in chlorogenic acid ( C-HCA ) , decaffeinated coffee high in chlorogenic acid , or decaffeinated coffee with regular amounts of chlorogenic acid ( D-RCA ) ; during the last @ d of the study , the weight-maintenance diet of subjects was supplemented with @ g fructose kg ( -@ ) d ( -@ ) ( total energy intake SD : @ @ % of weight-maintenance requirements ) .


All participants were also studied without coffee supplementation , either with @ g fructose kg ( -@ ) d ( -@ ) ( high fructose only ) or without high fructose ( control ) .


Compared with the control diet , the high-fructose diet significantly increased IHCLs by @ @ % and HGP by @ @ % and decreased fasting lipid oxidation by @ @ % ( all P < @ ) .


All @ coffees significantly decreased HGP .


Fasting lipid oxidation increased with C-HCA and D-RCA ( P < @ ) .


None of the @ coffees significantly altered IHCLs .


Coffee consumption attenuates hepatic insulin resistance but not the increase of IHCLs induced by fructose overfeeding .


This effect does not appear to be mediated by differences in the caffeine or chlorogenic acid content .


This trial was registered at clinicaltrials.gov as NCT@ .


High-sensitivity C-reactive protein ( hsCRP ) is an important biomarker of risk for coronary heart disease morbidity and mortality .


We investigated the influence of short-term cardiac rehabilitation ( CR ) after acute myocardial infarction ( AMI ) on values of hsCRP and classical risk factors , including metabolic syndrome .


hsCRP and classical risk factors were measured before and after completed @-week CR program in @ men after AMI .


The comparison group comprised @ age-balanced healthy men , with no risk factors for coronary heart disease .


As expected , in comparison to healthy individuals , patients had higher values of hsCRP ; furthermore , smokers had significantly higher hsCRP values than nonsmokers .


Patients had more expressed markers of metabolic syndrome and due to pharmacological therapy lower blood pressure , total cholesterol and low-density lipoprotein cholesterol ( LDL-C ) .


After CR was completed , a significant drop in hsCRP ( P = @ ) and improvement of metabolic syndrome parameters ( lower body mass index , blood pressure , LDL-C , triglycerides ) was observed in nonsmokers , whereas no such changes occurred in smokers .


Our study revealed that hsCRP and metabolic syndrome parameters can be substantially reduced by a @-week CR program ; however , this effect is present only in nonsmokers .


Thus , all patients entering the CR program after AMI should be advised to quit smoking before entering the program to achieve optimal benefits .


Many children do not engage in recommended levels of physical activity ( PA ) , highlighting the need to find ways to increase children 's PA. .


Process evaluations play an important role in improving the science of randomised controlled trials .


We recently reported the results of the Action @:@ cluster randomised feasibility trial illustrating higher levels of moderate to vigorous intensity PA among boys but not girls .


The aim of this paper is to report the process evaluation results including intervention fidelity , implementation , context and how intervention components and trial design could be improved before proceeding to a definitive RCT .


Children 's session enjoyment was assessed every two weeks .


Reasons for non-attendance were provided by questionnaire at the end of the intervention .


Post intervention interviews were held with participating teaching assistants ( TAs ) and school key contacts ( KCs ) , and focus groups were conducted with children in all @ intervention schools .


Interviews and focus groups examined how recruitment and session attendance might be improved and established which elements of the programme that were and were not well received .


Data indicated good intervention fidelity with TA 's adopting enjoyment-focussed teaching styles and the sessions improving children 's skills and self-esteem .


Several positive aspects of implementation were identified , including high session variety , the opportunity to work in teams , the child-led sessions and the engaging leader style .


In terms of context there was evidence that TA 's faced difficulties managing challenging behaviour and that further training in this area was needed .


TAs and KCs felt that recruitment could be improved by providing taster sessions during PE lessons and clarifying the days that the clubs would run at the point of recruitment .


The programme could be improved to enhance interest for girls , by including training for managing disruptive behaviour and making some activities more age-group appropriate .


Action @ showed promise but could be improved by ensuring age appropriate activities , providing more appeal to girls and improving recruitment through taster sessions and early establishment of days of the week it is to be offered on .


Increasing evidence suggests obesity has its origins prior to birth .


There is clear correlation between maternal obesity , high birthweight and offspring risk of obesity in later life .


It is also clear that women who are obese during pregnancy are at greater risk of adverse outcomes , including gestational diabetes and stillbirth .


The mechanism ( s ) by which obesity causes these problems is unknown , although hyperglycaemia and insulin resistance are strongly implicated .


We present a protocol for a study to test the hypothesis that metformin will improve insulin sensitivity in obese pregnant women , thereby reducing the incidence of high birthweight babies and other pregnancy complications .


The Efficacy of Metformin in Pregnant Obese Women , a Randomised controlled ( EMPOWaR ) trial is a double-masked randomised placebo-controlled trial to determine whether metformin given to obese ( body mass index > @kg/m ( @ ) ) pregnant women from @weeks ' gestation until delivery reduces the incidence of high birthweight babies .


A secondary aim is to test the mechanism ( s ) of any effect .


Obese women with a singleton pregnancy and normal glucose tolerance will be recruited prior to @weeks ' gestation and prescribed study medication , metformin or placebo , to be taken until delivery .


Further study visits will occur at @ and @weeks ' gestation for glucose tolerance testing and to record anthropometric measurements .


Birth weight and other measurements will be recorded at time of delivery .


Anthropometry of mother and baby will be performed at @months postdelivery .


As of January @ , @ women had been randomised across the UK .


Dissociation between plasma-free cortisol and total cortisol profiles exists in critical illness .


Data on plasma-free cortisol are based on either calculated values or immunoassay-based measurements .


Both have significant limitations .


Statins have been advocated as a therapy in sepsis .


Whether they impact on plasma cortisol through inhibition of cholesterol synthesis is unclear .


In patients enrolled into a randomized trial of statins in sepsis ( n = @ ) , we examined the association of mass spectrometry measured plasma-free cortisol , plasma-free cortisol/plasma total cortisol ratios , and outcome and the impact of concomitant statin therapy on cortisol profiles in @ steroid nave patients .


Two hundred twenty serial measurements of plasma-free cortisol , plasma total cortisol , and interleukin-@ were collected from @ patients ( @ placebo and @ statins ) .


Data from @ volunteers were used as controls .


Data are presented as median and interquartile range .


Compared with controls , in severe sepsis , baseline plasma total cortisol was elevated two-fold ( @ nmol/L -LSB- @-@ nmol/L -RSB- vs @ nmol/L -LSB- @-@ nmol/L -RSB- , p < @ ) , plasma-free cortisol @-fold ( @ nmol/L -LSB- @-@ nmol/L -RSB- vs @ nmol/L -LSB- @-@ nmol/L -RSB- , p < @ ) , and plasma-free cortisol/plasma total cortisol ratio six-fold ( @ vs @ , p = @ ) .


Baseline interleukin-@ was elevated at @ pg/mL ( @-@ pg/mL ) .


In severe sepsis , there were no differences in plasma total cortisol ( p = @ ) , plasma-free cortisol ( p = @ ) , and interleukin-@ ( p = @ ) between statins and placebo groups .


Plasma-free cortisol , plasma total cortisol , and plasma-free cortisol/plasma total cortisol were positively correlated with interleukin-@ ( p = @ , p < @ , and p < @ , respectively ) and day @ mortality ( p = @ , p = @ , and p = @ , respectively ) .


Elevated plasma-free cortisol/plasma total cortisol ratios were associated with increased length of stay ( p = @ ) .


Baseline plasma-free cortisol , plasma total cortisol , and plasma-free cortisol/plasma total cortisol ratios were higher in nonsurvivors as compared with survivors ( @ nmol/L -LSB- @-@ nmol/L -RSB- vs @ nmol/L -LSB- @-@ nmol/L -RSB- , p = @ ; @ nmol/L -LSB- @-@ ,@ nmol/L -RSB- vs @ nmol/L -LSB- @-@ nmol/L -RSB- , p = @ ; and @ -LSB- @-@ @ -RSB- vs @ -LSB- @-@ @ -RSB- ; p = @ , respectively ) .


In severe sepsis , plasma-free cortisol increase is @-fold greater than that of plasma total cortisol .


Both are similarly associated with inflammatory response and mortality .


Elevated plasma-free cortisol/plasma total cortisol ratios were associated with increased length of stay .


Statin therapy does not influence the plasma cortisol profiles in patients with severe sepsis .


The incidence of nosocomial infections in children in developed countries is still high , ranging from @ % to @ % , and standard preventive measures , such as increased hygiene , are not sufficiently efficacious .


One of the potential strategies for their prevention is the use of probiotics .


The aim of the study was to investigate the role of Bifidobacterium animalis subsp .


lactis in preventing nosocomial infections in the acute hospital setting .


We conducted a randomized , double-blind , placebo-controlled trial in @ hospitalized children ( aged @-@ y ) .


The children were randomly allocated to receive placebo ( placebo group , n = @ ) or B. animalis subsp .


lactis at a dose of @ ( @ ) colony-forming units/d ( intervention group , n = @ ) once daily for the entire duration of the hospital stay .


Nosocomial infections were defined as infections that occurred > @ h after hospital admission and that were not present or incubating at the time of admission .


Analysis was performed on an intention-to-treat basis .


There was no difference in the study primary outcome or incidence of common nosocomial gastrointestinal and respiratory tract infections between groups ( @ vs. @ infections , respectively ; incidence rate ratio = @ ; @ % CI : @ , @ ; P = @ ) .


No difference was found for the duration of common nosocomial infections -LSB- mean ( range ) : @ ( @-@ ) vs. @ ( @-@ ) d , in placebo vs. intervention group ; P = @ -RSB- .


There was also no difference between the intervention and placebo groups for any of the other secondary outcomes ( incidence of gastrointestinal and respiratory tract infections separately , duration of gastrointestinal and respiratory infections , and duration of hospitalization ) and exploratory outcomes ( gastrointestinal and respiratory symptoms , severity of gastrointestinal and respiratory tract infections , and the use of antibiotics ) .


The results of this study show that the use of B. animalis subsp .


lactis failed to prevent nosocomial infections in an acute-setting pediatric hospital in children who were > @ y of age .


However , it should be taken into account that the overall incidence of nosocomial infections was lower than expected .


This trial was registered at clinicaltrials.gov as NCT@ .


Hyperphosphatemia necessitates the use of phosphate binders in most dialysis patients .


Long-term efficacy and tolerability of the iron-based phosphate binder , sucroferric oxyhydroxide ( previously known as PA@ ) , was compared with that of sevelamer carbonate ( sevelamer ) in an open-label Phase III extension study .


In the initial Phase III study , hemo - or peritoneal dialysis patients with hyperphosphatemia were randomized @:@ to receive sucroferric oxyhydroxide @-@ @ g/day ( @-@ tablets/day ; n = @ ) or sevelamer @-@ @ g/day ( @-@ tablets/day ; n = @ ) for @ weeks .


Eligible patients could enter the @-week extension study , continuing the same treatment and dose they were receiving at the end of the initial study .


Overall , @ patients were available for efficacy analysis ( n = @ sucroferric oxyhydroxide ; n = @ sevelamer ) .


Serum phosphorus concentrations were maintained during the extension study .


Mean standard deviation ( SD ) change in serum phosphorus concentrations from extension study baseline to Week @ end point was @ @ mmol/L with sucroferric oxyhydroxide and @ @ mmol/L with sevelamer .


Mean serum phosphorus concentrations remained within Kidney Disease Outcomes Quality Initiative target range ( @-@ @ mmol/L ) for both treatment groups .


Mean ( SD ) daily tablet number over the @-week extension study was lower for sucroferric oxyhydroxide ( @ @ ) versus sevelamer ( @ @ ) .


Patient adherence was @ % with sucroferric oxyhydroxide versus @ % with sevelamer .


Mean serum ferritin concentrations increased over the extension study in both treatment groups , but transferrin saturation ( TSAT ) , iron and hemoglobin concentrations were generally stable .


Gastrointestinal-related adverse events were similar and occurred early with both treatments , but decreased over time .


The serum phosphorus-lowering effect of sucroferric oxyhydroxide was maintained over @ year and associated with a lower pill burden , compared with sevelamer .


Sucroferric oxyhydroxide was generally well tolerated long-term and there was no evidence of iron accumulation .


Previous studies have already substantiated alcohol 's causal role in injuries .


Yet the role that alcoholic beverage preferences and the drinking context play in the risk for injury is still under-investigated .


In this study , a cross-national comparison of the association between alcohol and injury focusing on beverage type preference and the drinking context is reported .


Emergency department ( ED ) injured patients were interviewed in eight countries from the Latin American and Caribbean ( LAC ) region .


Data on the type of alcoholic beverage , total alcohol volume , and the place where the injury occurred were obtained from patients who reported any alcohol consumption within @h prior to being injured .


Patients who did not drink prior to injury were also asked about their typical drinking pattern and the injury place .


Differences within - and between-groups were evaluated regarding patients ' typical drinking and drinking before injury .


Beer was the most prevalent beverage type usually consumed among injured patients across countries , however , patients who drank before injury had a higher typical consumption of spirits than those not drinking prior to injury .


The total alcohol volume typically consumed and drinking in public settings were also found to be positively associated with alcohol-related injury .


A similar beverage-specific association with alcohol-related injury was found across LAC countries , mainly attributed to beer consumption , and spirits drinkers seem to have a greater chance of becoming involved in injury events .


Future prevention strategies should inform the public about harms from drinking associated with the context in which drinking takes place .


Seasonal influenza causes > @ @ annual hospitalizations in the United States .


Current antiviral treatment options are limited to oral or inhaled agents .


There is an urgent unmet need for intravenous antiviral treatments .


Patients hospitalized with suspected influenza were randomized to @-day treatment with intravenous peramivir ( @ mg once daily ) or placebo ; all received the institution 's standard of care ( SOC ) treatment .


Time to clinical resolution and change in viral shedding in nasopharyngeal specimens were the primary and key secondary end points .


Influenza infection was confirmed in @ of @ enrolled patients .


At the time of a preplanned interim analysis , the primary efficacy analysis population comprised @ patients who did not receive a concurrent neuraminidase inhibitor as part of the SOC .


The median ( @ % confidence interval ) time to clinical resolution was @ ( @-@ @ ) hours for peramivir versus @ ( @-@ @ ) hours for placebo ( P = @ ) .


A larger treatment effect was observed in patients with history of symptoms < @ hours or admitted to an intensive care unit .


Greater reductions in viral shedding , based on median tissue culture infective dose , were observed in patients who received peramivir than in placebo recipients , although this difference was not statistically significant .


The incidence and severity of adverse events and laboratory abnormalities were similar between the @ treatment groups .


The study was terminated for futility after a preplanned interim analysis .


A significant clinical benefit was not demonstrated for peramivir plus SOC compared with placebo plus SOC .


Peramivir was generally safe and well tolerated .


These findings highlight the challenges in designing studies to evaluate influenza antiviral agents in a hospitalized setting .


Clinical Trials Registration.NCT@ .


The authors of this randomized study had for aim to evaluate the impact of training on proper glove use by comparing compliance to glove use recommendations between trained and untrained healthcare personnel according to healthcare professional groups .


A random selection of trained and untrained nurses , nurse aids , and hospital housekeepers was performed in a French University hospital , using a listing of healthcare personnel .


The audits were conducted by two infection control nurses , in series of @ observations , with a maximum time limit of two hours .


The evaluation criteria were compliance or non-compliance of glove-wearing practices with internal hospital recommendations , disclosed to professionals during training .


Overall , @ professionals were audited and @ acts were observed .


Hand hygiene was significantly better in trained vs. untrained healthcare professionals ( P < @ ) .


Proper glove use practices were similar between trained and untrained nurses ( @ % of compliance ) , whereas the difference was statistically significant in favor of trained healthcare personnel for the other categories ( P < @ for nurse aids and P = @ for housekeepers ) .


We demonstrated the impact of pluridisciplinary training on proper glove use practices in hospital settings , but with different benefits found according to professional groups .


The lower the initial training level , the greater the overall benefit appeared to be .


To assess the reliability and validity of scores derived from the Patient Perception of Intensity of Urgency Scale ( PPIUS ) in patients with lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) .


A post hoc analysis of the phase II Solifenacin and Tamsulosin in Males with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia trial ( NCT@ ) , a @-week clinical trial in men with LUTS associated with BPH , assessed the measurement properties of six PPIUS-derived scores : mean score ; maximum urgency score ; total urgency and frequency score ( TUFS ; average sum of urgency scores over @ days ) ; and numbers of urgency episodes , urgency episodes of grade @ or @ , and urgency incontinence episodes .


Test-retest reliability , presence of floor/ceiling effects , responsiveness to change , known-group validity , and concurrent validity were assessed for each score .


A total of @ patients had at least one valid PPIUS assessment after baseline .


TUFS demonstrated good test-retest reliability ( intraclass correlation coefficient > @ ) , discriminated between groups defined based on International Prostate Symptom Score storage score severity ( known-groups validity ) , had high concurrent validity , and had high responsiveness to change ( Guyatt 's responsiveness statistic @ ) , with an absence of floor or ceiling effects .


The psychometric properties of other PPIUS-derived scores were not as consistently robust and showed either low-to-moderate responsiveness , presence of a floor or ceiling effect , or low-to-moderate test-retest reliability .


This study shows that the PPIUS is reliable and valid in patients with LUTS associated with BPH .


TUFS provided the best combination of psychometric properties of the six scores derived from the PPIUS and appeared to be an appropriate measure of urgency and frequency .


In preclinical work and retrospective population studies , the anti-diabetic drug metformin has been associated with antineoplastic activity and decreased burden of many cancers , including pancreatic cancer .


There is therefore interest in the hypothesis that this drug might be repurposed for indications in oncology .


We aimed to assess the efficacy of the addition of metformin to a standard systemic therapy in patients with advanced pancreatic cancer , and provide the first report of a clinical trial with a survival endpoint of metformin for an oncological indication .


We did this double-blind , randomised , placebo-controlled phase @ trial at four centres in the Netherlands .


Patients aged @ years or older with advanced pancreatic cancer were randomly assigned ( @:@ ) , via a permutated computer-generated block allocation scheme ( block size of six ) to receive intravenous gemcitabine ( @ mg/m ( @ ) ) on days @ , @ , and @ every @ weeks and oral erlotinib ( @mg ) once daily in combination with either oral metformin or placebo twice daily .


Metformin dose was escalated from @ mg ( in the first week ) to @ mg twice daily in the second week .


Randomisation was stratified by hospital , diabetes status , and tumour stage .


The primary endpoint was overall survival at @ months in the intention-to-treat population .


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


Between May @ , @ , and Jan @ , @ , we randomly assigned @ patients to receive gemcitabine and erlotinib with either placebo ( n = @ ) or metformin ( n = @ ) .


Overall survival at @ months was @ % ( @ % CI @-@ ) in the placebo group and @ % ( @-@ ) in the metformin group ( p = @ ) .


There was no difference in overall survival between groups ( median @ months -LSB- @ % CI @-@ -RSB- vs @ months -LSB- @ % CI @-@ -RSB- in the metformin group ; hazard ratio -LSB- HR -RSB- @ -LSB- @ % CI @-@ -RSB- ; log-rank p = @ ) .


The most frequent grade @-@ toxic effects were neutropenia ( @ -LSB- @ % -RSB- patients in placebo group vs @ -LSB- @ % -RSB- in metformin group ) , skin rash ( six -LSB- @ % -RSB- vs four -LSB- @ % -RSB- ) , diarrhoea ( three -LSB- @ % -RSB- vs six -LSB- @ % -RSB- ) , and fatigue ( two -LSB- @ % -RSB- vs six -LSB- @ % -RSB- ) .


Addition of a conventional anti-diabetic dose of metformin does not improve outcome in patients with advanced pancreatic cancer treated with gemcitabine and erlotinib .


Future research should include studies of more potent biguanides , and should focus on patients with hyperinsulinaemia and patients with tumours showing markers of sensitivity to energetic stress , such as loss of function of AMP kinase , a key regulator of cellular energy homoeostasis .


Prosthetic repair has become the standard method for hernia repair .


Mesh placement for the prevention of trocar site incisional hernia ( TSIH ) is still a controversial issue .


We tested the hypothesis that closure with an intraperitoneal prophylactic mesh of the umbilical trocar after a laparoscopic cholecystectomy can reduce the incidence of a TSIH in high-risk patients .


A randomized clinical trial was conducted among patients undergoing elective laparoscopic cholecystectomy who presented the following high-risk factors for incisional hernia , according to the literature : age @ years and older , diabetes mellitus , chronic pulmonary disease , and obesity ( ie , body mass index @ kg/m ( @ ) ) .


Patients were assigned to have closure of the umbilical trocar site with either nonabsorbable sutures ( group A ) or intraperitoneal polypropylene omega-@ mesh ( group B ) .


Trocar site incisional hernia , pain , and surgical complications were evaluated at the early postoperative course and at @ , @ , and @ months after surgery .


A total of @ patients were randomized into the study and @ patients were finally analyzed , including @ in group A and @ in group B.


The TSIH rate was higher in group A ( @ % ) than in group B ( @ % ) ( odds ratio = @ ; @ % CI , @-@ @ ; p < @ ) ) .


The wound infection rate was @ % ; @ % in group A and @ % in group B ( odds ratio = @ ; @ % CI , @-@ @ ; p = @ ) .


Median postoperative pain evaluated by a visual analogue scale was @ in group A and @ in group B ( p = @ ) .


No differences were observed in complication rate , operative time , or hospital stay between the groups .


Prosthetic closure of the umbilical trocar site after laparoscopic surgery could become the standard method for preventing TSIH in high-risk patients .


Etamicastat is a dopamine - hydroxylase ( DH ) inhibitor currently in clinical development for the treatment of hypertension and heart failure .


This study assessed the tolerability , pharmacokinetics , and pharmacodynamics of etamicastat in patients with arterial hypertension .


This randomized , double-blind , placebo-controlled study was conducted in male patients aged between @ and @ years with mild to moderate hypertension .


Participants received once-daily doses of etamicastat @ , @ , or @ mg or placebo for @ days .


Antihypertensive effect was assessed by @-hour ambulatory blood pressure monitoring ( ABPM ) .


The study enrolled @ male volunteers , with ages between @ and @ years .


There were no serious adverse events reported .


All adverse events were mild to moderate in intensity and resolved without sequelae .


Etamicastat Tmax was @ hour postdose , and mean t was @ to @ hours following repeated administration .


Etamicastat underwent N-acetylation by N-acetyltransferase @ ( NAT@ ) , forming the metabolite BIA @-@ .


Following repeated administration , mean etamicastat AUC was @ - to @-fold greater in poor acetylators than in rapid acetylators .


Approximately @ % of the etamicastat dose was recovered in urine-@ % as unchanged etamicastat and @ % as BIA @-@ .


Dose-dependent decreases in systolic and diastolic blood pressure were observed after @ days of treatment .


The mean ( @ % CI ) decreases versus placebo in nighttime SBP were statistically significant with all @ etamicastat doses ( @ mg , -@ mm Hg -LSB- -@ to -@ ; P < @ -RSB- ; @ mg , -@ mm Hg -LSB- -@ to -@ ; P < @ -RSB- ; and @ mg , -@ mm Hg -LSB- -@ to -@ ; P < @ -RSB- ) .


Etamicastat was well tolerated and showed a pharmacokinetic profile consistent with a once-daily regimen .


NAT@ phenotype markedly affected the pharmacokinetics .


The antihypertensive effect of etamicastat , assessed by @-hour ABPM , was dose dependent up to @ mg .


The assessment of etamicastat as a novel antihypertensive therapy requires further study in broader populations .


EudraCT trial registration @-@-@ .


This study aims to assess possible wound complications of tympanoplasty and tympanomastoidectomy with or without postoperative mastoid dressing .


A total of @ patients ( @ females , @ males ; mean age : @ years ; range @ to @ years ) who underwent middle ear or mastoid operations via postauricular incision were included in this prospective , randomized , controlled study .


The patients were divided into two groups as having mastoid dressing ( n = @ ) and nonmastoid dressing ( n = @ ) .


Through a close follow-up , postoperative complications were noted and distance from mastoid scalp and auricular rim was measured .


The mean mastoid-helix distance of non-mastoid dressing group was found @ mm in operated and @ mm in non-operated ears .


The mean mastoid-helix distance of mastoid dressing group was @ mm in operated ears and @ mm in non-operated ears .


Skin erythema was seen in a patient .


There was no statistically significant increase in mastoid-helix distance ( p > @ ) .


Tympanoplasty with or without mastoidectomy does not cause postoperative complication or protrusion of the ear , even if no mastoid dressing is used .


Our study results suggest no benefit of mastoid dressing after tympanoplasty with or without mastoidectomy .


This randomized clinical trial evaluates interscalene brachial plexus block ( ISB ) , general anaesthesia ( GA ) and the combination of both anaesthetic methods ( GA + ISB ) in patients undergoing shoulder arthroscopy .


From July @ until May @ , @ patients ( male/female ) , aged @-@ years , were allocated randomly to receive ISB ( @ ml mepivacaine @ % and @ ml ropivacaine @ % ) , GA ( propofol , sunfentanil , desflurane ) or ISB + GA. .


The primary outcome variable was opioid consumption at the day of surgery .


Anaesthesia times were analysed as secondary endpoints .


After surgery , @ of @ patients with a single ISB bypassed the recovery room ( p < @ ) .


Postoperative monitoring time was significantly shorter with single ISB compared with both other groups -LSB- GA : @ ( @-@ ) min vs. GA + ISB : @ ( @-@ ) min vs. ISB : @ ( @-@ ) min , p < @ -RSB- .


Opioid consumption was reduced using a single ISB at the day of surgery -LSB- GA : n = @ vs. GA + ISB : n = @ vs. ISB : n = @ , p = @ -RSB- .


ISB is superior to GA and GA + ISB in patients undergoing shoulder arthroscopy in terms of faster recovery and analgesics consumption .


Bisphosphonates are routinely used in the treatment of metastatic bone disease from breast cancer to reduce pain and bone destruction .


Zoledronic acid given by intravenous infusion has been widely used , but places a substantial logistical burden on both patient and hospital .


As a result , the use of oral ibandronic acid has increased , despite the absence of comparative data .


In the ZICE trial , we compared oral ibandronic acid with intravenous zoledronic acid for the treatment of metastatic breast cancer to bone .


This phase @ , open-label , parallel group active-controlled , multicentre , randomised , non-inferiority phase @ study was done in @ UK hospitals .


Eligibility criteria included at least one radiologically confirmed bone metastasis from a histologically confirmed breast cancer .


Patients with ECOG performance status @ to @ and clinical decision to treat with bisphosphonates within @ months of randomisation were randomly assigned to receive @ weeks of treatment with either intravenous zoledronic acid at @ mg every @-@ weeks or oral ibandronic acid @ mg daily .


Randomisation ( @:@ ) was done via a central computerised system within stratified block sizes of four .


Randomisation was stratified on whether patients had current or planned treatment with chemotherapy ; current or planned treatment with hormone therapy ; and whether they had a previous skeletal-related event within the last @ months or had planned radiotherapy treatment to the bone or planned orthopaedic surgery due to bone metastases .


The primary non-inferiority endpoint was the frequency and timing of skeletal-related events over @ weeks , analysed using a per-protocol analysis .


All active ( non-withdrawn ) patients have now reached the @-week timepoint and the trial is now in long-term follow-up .


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


Between Jan @ , @ , and Oct @ , @ , @ patients were randomly assigned to receive ibandronic acid and @ to receive zoledronic acid ; three patients withdrew immediately after randomisation .


The per-protocol analysis included @ patients in the ibandronic acid group and @ in the zoledronic acid group .


Annual rates of skeletal-related events were @ ( @ % CI @-@ ) with ibandronic acid and @ ( @-@ ) with zoledronic acid ; the rate ratio for skeletal-related events was @ ( @ % CI @-@ ) .


The upper CI was greater than the margin of non-inferiority of @ ; therefore , we could not reject the null hypothesis that ibandronic acid was inferior to zoledronic acid .


More patients in the zoledronic acid group had renal toxic effects than in the ibandronic acid group ( @ -LSB- @ % -RSB- of @ vs @ -LSB- @ % -RSB- of @ ) but rates of osteonecrosis of the jaw were low in both groups ( nine -LSB- @ % -RSB- of @ vs five -LSB- < @ % -RSB- of @ ) .


The most common grade @ or @ adverse events were fatigue ( @ -LSB- @ % -RSB- of @ patients allocated zoledronic acid vs @ -LSB- @ % -RSB- of @ allocated ibandronic acid ) , increased bone pain ( @ -LSB- corrected -RSB- -LSB- @ % -RSB- vs @ -LSB- corrected -RSB- -LSB- @ % -RSB- ) , joint pain ( @ -LSB- corrected -RSB- -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , infection ( @ -LSB- @ % -RSB- vs @ -LSB- corrected -RSB- -LSB- @ % -RSB- ) , and nausea or vomiting ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


Our results suggest that zoledronic acid is preferable to ibandronic acid in preventing skeletal-related events caused by bone metastases .


However , both drugs have acceptable side-effect profiles and the oral formulation is more convenient , and could still be considered if the patient has a strong preference or if difficulties occur with intravenous infusions .


To determine bispectral index ( BIS ) values produced by equipotent concentrations of commonly used volatile anaesthetics .


Female patients undergoing thyroidectomy were randomly assigned to receive isoflurane , sevoflurane or desflurane anaesthesia .


After induction , anaesthesia was maintained by the volatile agent at @ minimum alveolar concentration and supplemented with remifentanil infusion .


BIS values were recorded during @h surgical anaesthesia after a @min equilibrium phase .


Time-averaged BIS value during the study period was significantly lower in the desflurane group ( n = @ ) than the sevoflurane group ( n = @ ) ( @ vs @ ) .


Duration of deep hypnosis ( BIS < @ ) was significantly longer in the desflurane group than the sevoflurane group ( @ vs @ min ) .


There were no significant differences in any parameter between the isoflurane group ( n = @ ) and any other group .


Desflurane produces a greater hypnotic effect than sevoflurane during equipotent anaesthesia .


Management of volatile anaesthesia using predetermined minimum alveolar concentration targets can lead to an unnecessarily long duration of deep hypnosis .


Diagnostic esophagogastroduodenoscopy ( EGD ) is uncomfortable for most patients .


We determined the efficacy of alprazolam , administered orally or sublingually , as premedication for sedation during EGD .


Adult EGD candidates were randomly allocated to four groups ( n = @ , each group ) and received alprazolam ( @ mg ) sublingually or orally , placebo sublingually or orally at @ minutes before EGD .


Main outcome measures included procedure-related anxiety and pain/discomfort ( assessed using @-point numeric scales ) , patient overall tolerance ( assessed using a @-point Likert scale ) , need for intravenous sedation , and willingness to repeat the EGD if necessary .


Patients experienced greater reduction in anxiety score after medication with sublingual alprazolam ( mean @ , standard deviation -LSB- SD -RSB- @ ) compared with sublingual placebo ( mean @ , standard error -LSB- SE -RSB- @ -RSB- ; P < @ ) and oral alprazolam ( @ , SE @ ; P < @ ) .


Also , pain/discomfort scores were lower with sublingual alprazolam compared with sublingual placebo ( @ , SE @ vs. @ , SD @ ; P = @ ) , and with oral alprazolam compared with oral placebo ( @ , SD @ vs. @ , SD @ ; P < @ ) .


Patient overall tolerance was better with sublingual alprazolam than with sublingual placebo ( P = @ ) or with oral alprazolam ( P = @ ) .


Regarding intravenous sedation , there was no difference between sublingual alprazolam and sublingual placebo ( @ % vs. @ % ; P = @ ) or between oral alprazolam and oral placebo ( @ % vs. @ % ; P = @ ) .


Willingness to repeat the procedure was greater with sublingual alprazolam than with sublingual placebo ( @ % vs. @ % ; P = @ ) .


Sublingual alprazolam is an effective premedication for sedation during EGD .


It reduces anxiety and pain/discomfort related to EGD and increases patient tolerance and willingness to repeat the EGD if necessary .


Drug users ( DUs ) , a population that accounts for some of the fastest-growing human immunodeficiency virus ( HIV ) epidemics globally , lag behind other populations with regard to HIV-related outcomes .


We evaluated the role of voucher incentives on linkage and retention in care among DUs in India .


In this randomized clinical trial , @ DUs who were aged @ years , HIV-infected , antiretroviral therapy ( ART ) naive , and ART eligible and who reported drug use in the prior month were randomized to incentive ( INC ) or control ( CTL ) conditions for @ months .


Participants randomized to the INC arm received incentives ( redeemable for food/household goods ) ranging in value from USD@ to USD@ for achieving prespecified targets ( eg , ART initiation , visits to ART center ) .


Subjects in the CTL group could win vouchers in prize-bowl drawings , but HIV care behaviors were not incentivized .


The primary endpoint was time to ART initiation .


Sixty participants each were randomized to the INC and CTL arms between December @ and September @ .


Participants in the INC arm were more likely to visit the government ART center ( @ vs @ ; P = @ ) ; @ participants in the INC and @ participants in the CTL arm initiated ART ( P = @ ; hazard ratio for ART = @ -LSB- @ % confidence interval , @-@ @ -RSB- ) .


Participants in the INC arm also had significantly more visits to the ART center ( median number of visits , @ vs @ ; P = @ ) .


However , no difference in viral suppression was observed .


Modest voucher incentives improved linkage to and retention in HIV care , but did not significantly impact viral suppression among DUs in India , a disenfranchised and difficult-to-treat population .


Obstructive sleep apnea ( OSA ) is associated with increased risk of cardiovascular and cerebrovascular disease resulting from intermittent hypoxia ( IH ) - induced inflammation .


Cyclooxygenase ( COX ) - formed prostanoids mediate the inflammatory response , and regulate blood pressure and cerebral blood flow ( CBF ) , but their role in blood pressure and CBF responses to IH is unknown .


Therefore , this study 's objective was to determine the role of prostanoids in cardiovascular and cerebrovascular responses to IH .


Twelve healthy , male participants underwent three , @-hour IH exposures .


For @ days before each IH exposure , participants ingested a placebo , indomethacin ( nonselective COX inhibitor ) , or Celebrex ( ) ( selective COX-@ inhibitor ) in a double-blind , randomized , crossover study design .


Pre - and post-IH blood pressure , CBF , and urinary prostanoids were assessed .


Additionally , blood pressure and urinary prostanoids were assessed in newly diagnosed , untreated OSA patients ( n = @ ) .


Nonselective COX inhibition increased pre-IH blood pressure ( P @ ) and decreased pre-IH CBF ( P = @ ) while neither physiological variable was affected by COX-@ inhibition ( P @ ) .


Post-IH , MAP was elevated ( P @ ) and CBF was unchanged with placebo and nonselective COX inhibition .


Selective COX-@ inhibition abrogated the IH-induced MAP increase ( P = @ ) , but resulted in lower post-IH CBF ( P = @ ) .


Prostanoids were unaffected by IH , except prostaglandin E@ was elevated with the placebo ( P = @ ) .


Finally , OSA patients had elevated blood pressure ( P @ ) and COX-@ formed thromboxane A@ concentrations ( P = @ ) .


COX-@ and COX-@ have divergent roles in modulating vascular responses to acute and chronic IH .


Moreover , COX-@ inhibition may mitigate cardiovascular and cerebrovascular morbidity in OSA .


The prognostic and predictive value of the proliferation marker Ki-@ was investigated in a randomized trial comparing accelerated radiotherapy with carbogen breathing and nicotinamide ( ARCON ) to accelerated radiotherapy in laryngeal carcinoma .


Labeling index of Ki-@ ( Li Ki-@ ) in immunohistochemically stained biopsies and the colocalization with carbonic anhydrase IX ( CAIX ) were related to tumor control and patient survival .


On average , node-positive patients had a higher Li Ki-@ ( median @ % vs @ % ; p < @ ) .


In patients with a high Li Ki-@ , the @-year regional control and metastases-free survival were @ % versus @ % ( p < @ ) and @ % versus @ % ( p = @ ) for accelerated radiotherapy and ARCON , respectively .


The @-year local control and disease-specific survival were not significantly different .


Patients with low Ki-@ expression had an excellent outcome with accelerated radiotherapy alone .


Patients with laryngeal carcinomas with high proliferative activity are at increased risk of regional and distant metastases formation .


This risk can be reduced by treatment with ARCON .


Assessment and discussion of individual risk for breast cancer within the primary care setting are crucial to discussion of risk reduction and timely referral .


We conducted a randomized controlled trial of a multiethnic , multilingual sample of women ages @ to @ years from two primary care practices ( one academic , one safety net ) to test a breast cancer risk assessment and education intervention .


Patients were randomly assigned to control or intervention group .


All patients completed a baseline telephone survey and risk assessment ( via telephone for controls , via tablet computer in clinic waiting room before visit for intervention ) .


Intervention ( BreastCARE ) patients and their physicians received an individualized risk report to discuss during the visit .


One-week follow-up telephone surveys with all patients assessed patient-physician discussion of family cancer history , personal breast cancer risk , high-risk clinics , and genetic counseling/testing .


A total of @ control and @ intervention women completed the risk assessment and follow-up interview ; @ % were high-risk by family history , Gail , or Breast Cancer Surveillance Consortium risk models .


BreastCARE increased discussions of family cancer history -LSB- OR , @ ; @ % confidence interval ( CI ) , @-@ @ -RSB- , personal breast cancer risk ( OR , @ ; @ % CI , @-@ @ ) , high-risk clinics ( OR , @ ; @ % CI , @-@ @ ) , and genetic counseling/testing ( OR , @ ; @ % CI , @-@ @ ) .


Among high-risk women , all intervention effects were stronger .


An intervention combining an easy-to-use , quick risk assessment tool with patient-centered risk reports at the point of care can successfully promote discussion of breast cancer risk reduction between patients and primary care physicians , particularly for high-risk women .


Next steps include scaling and dissemination of BreastCARE with integration into electronic medical record systems .


The medical priority dispatch system ( MPDS ) assists lay rescuers in protocol-driven telephone-assisted cardiopulmonary resuscitation ( CPR ) .


Our aim was to clarify which CPR instruction leads to sufficient compression depth .


This was an investigator-blinded , randomized , parallel group , simulation study to investigate @min of chest compressions after the instruction `` push down firmly @cm '' vs. `` push as hard as you can . ''


Primary outcome was defined as compression depth .


Secondary outcomes were participants exertion measured by Borg scale , provider 's systolic and diastolic blood pressure , and quality values measured by the skill-reporting program of the Resusci ( ) Anne Simulator manikin .


For the analysis of the primary outcome , we used a linear random intercept model to allow for the repeated measurements with the intervention as a covariate .


Thirteen participants were allocated to control and intervention .


One participant ( intervention ) dropped out after min @ because of exhaustion .


Primary outcome showed a mean compression depth of @ mm , with an inter-individual standard deviation ( SDb ) of @ mm and an intra-individual standard deviation ( SDw ) of @ mm for the control group vs. @ mm and a SDb of @ mm and SDw of @ mm for the intervention group ( difference : @ ; @ % confidence interval -@ to @ ; p = @ ) .


Secondary outcomes showed no difference for exhaustion and CPR-quality values .


There is no difference in compression depth , quality of CPR , or physical strain on lay rescuers using the initial instruction `` push as hard as you can '' vs. the standard MPDS ( ) instruction `` push down firmly @cm . ''


Antioxidant donor pretreatment is one of the pharmacologic strategy proposed to prevent renal ischemia-reperfusion injuries and delayed graft function ( DGF ) .


The aim of the study was to investigate whether a donor pretreatment with N-acetylcysteine ( NAC ) reduces the incidence of DGF in adult human kidney transplant recipients .


In this randomized , open-label , monocenter trial , @ deceased heart-beating donors were allowed to perform @ renal transplantations from September @ to December @ .


Donors were randomized to receive , in a single-blind controlled fashion , @ mg of intravenous NAC @ hr before and @ hr after cerebral angiography performed to confirm brain death .


Primary endpoint was DGF defined by the need for at least one dialysis session within the first week or a serum creatinine level greater than @ mol/L at day @ after kidney transplantation .


The incidence of DGF was similar between donors pretreated with or without NAC ( @/@ ; @ % vs. @/@ ; @ % ; P = @ ) .


Requirement for at least one dialysis session was not different between the NAC and No NAC groups ( @/@ ; @ % vs. @/@ ; @ % , P = @ ) .


The two groups had comparable serum creatinine levels , estimated glomerular filtration rates , and daily urine output at days @ , @ , @ , and @ after kidney transplantation as well as at hospital discharge .


No difference in recipient mortality nor in @-year kidney graft survival was observed .


Donor pretreatment with NAC does not improve delayed graft function after kidney transplantation .


Some anesthesiologists consider combined spinal epidural ( CSE ) analgesia as superior alternative to continuous labor epidural ( CLE ) analgesia .


However , during CSE , even small doses of intrathecally administered local anesthetics with opioids induce almost instant analgesia that precludes the testing of epidural catheters as well as early appreciation of failed epidural catheters .


To overcome the shortcomings of CSE analgesia , dural puncture epidural ( DPE ) analgesia had been devised .


The goals for the present study were to test whether DPE technique would provide superior and safer labor analgesia as compared to CLE technique .


@ ASA Class I , II and III pregnant patients who requested labor epidural analgesia consented for their participation in this prospective randomized study .


Group A patients received CLE analgesia for labor pain .


Group B patients received DPE analgesia for labor pain .


After exclusion of nineteen patients , final comparative data was available for @ patients only -LSB- Group A ( n = @ ) versus Group B ( n = @ ) -RSB- .


Per our analysis , the only positive aspect for DPE analgesia as compared to CLE analgesia was that patients who received DPE analgesia reported lower incidence for immediate failures of labor analgesia ( P = @ ) .


However , there was higher incidence of paresthesias while performing successful dural punctures ( P < @ ) .


Pre-insertion epidural depth assessment with ultrasound ( n = @ ) correlated positively with the air-filled loss of resistance syringe technique ( r = @ ; P < @ ) .


DPE technique did not provide superior labor analgesia as compared to CLE technique .


Technically , fewer immediate failures in labor analgesia but higher incidence of paresthesias were observed with DPE technique .


To determine whether the addition of @weeks of subcutaneous peginterferon -- @b could reduce the requirement for systemic corticosteroids and conventional immunosuppressive medication in patients with Behet 's disease ( BD ) .


We conducted a multicentre randomised trial in patients with BD requiring systemic therapy .


Patients were randomised to @weeks of peginterferon -- @b in addition to their standard care or to standard care only and followed @-monthly for @years with BD activity scores and quality of life questionnaires .


Patients at one centre had blood taken to measure regulatory T cells ( Tregs ) and Th@ cells .


@ patients were included .


At months @-@ , while among the entire patient population there was no difference in the corticosteroid dose or immunosuppression use between the treatment groups ( adjusted OR @ , @ % CI @ to @ ) , post hoc analysis revealed that in patients who were on corticosteroids at baseline the corticosteroid requirement was significantly lower in the peginterferon -- @b ( @ ( @-@ ) mg/day ) compared with the non-interferon group ( @ ( @-@ @ ) mg/day , p = @ ) .


Furthermore , there was a trend towards an improved quality of life that became significant by @months ( p = @ ) .


This was associated with a significant rise in Tregs and a decrease in Th@ cells which was still present at @year and @months after the interferon was stopped .


The safety profile was similar with adverse events in @ % in both groups .


The addition of peginterferon -- @b to the drug regime of BD patients did not significantly reduce their corticosteroid dose required at @year .


However , in those on corticosteroids at baseline post hoc analysis demonstrated that the addition of peginterferon -- @b did result in a significant reduction in corticosteroid dose with a significantly improved quality of life and trend to reduce other required immunosuppressive agents .


This effect was seen at @year and associated with a rise in Tregs suggesting a possible mode for interferon action .


Low levels of physical activity are common in patients with chronic obstructive pulmonary disease ( COPD ) , and a sedentary lifestyle is associated with poor outcomes including increased mortality , frequent hospitalizations , and poor health-related quality of life .


Internet-mediated physical activity interventions may increase physical activity and improve health outcomes in persons with COPD .


This manuscript describes the design and rationale of a randomized controlled trial that tests the effectiveness of Taking Healthy Steps , an Internet-mediated walking program for Veterans with COPD .


Taking Healthy Steps includes an uploading pedometer , a website , and an online community .


Eligible and consented patients wear a pedometer to obtain one week of baseline data and then are randomized on a @:@ ratio to Taking Healthy Steps or to a wait list control .


The intervention arm receives iterative step-count feedback ; individualized step-count goals , motivational and informational messages , and access to an online community .


Wait list controls are notified that they are enrolled , but that their intervention will start in one year ; however , they keep the pedometer and have access to a static webpage .


Participants include @ Veterans ( mean age @ years , @ % male ) with @ randomized to Taking Healthy Steps and @ to the wait list control arm ; rural-living ( @ % ) ; ever-smokers ( @ % ) ; and current smokers ( @ % ) .


Baseline mean St. George 's Respiratory Questionnaire Total Score was @ ; @ % reported severe dyspnea ; and the average number of comorbid conditions was @ .


Mean baseline daily step counts was @ ( + / - @ ) .


Veterans with COPD can be recruited to participate in an online walking program .


We successfully recruited a cohort of older Veterans with a significant level of disability including Veterans who live in rural areas using a remote national recruitment strategy .


Methods to improve neurocognitive impairments are of important research interest .


This study sought to examine the synergistic effects of neurocognitive rehabilitation and antipsychotics for schizophrenia .


Subjects were @ patients diagnosed with schizophrenia or schizoaffective disorder in a randomized trial of the effects of neurocognitive rehabilitation or a quasi-randomized experimental trial of supported employment with neurocognitive rehabilitation .


We compared the effects of risperidone and aripiprazole in neurocognitive rehabilitation for schizophrenia .


Subjects were divided into the following groups : ( i ) the control-risperidone group ( CR group ) ( n = @ ) ; ( ii ) the rehabilitation-risperidone group ( RR group ) ( n = @ ) ; ( iii ) the control-aripiprazole group ( CA group ) ( n = @ ) ; and ( iv ) the rehabilitation-aripiprazole group ( RA group ) ( n = @ ) .


Subjects in the rehabilitation group were engaged in computer-based cognitive exercises ( @ sessions ) with bridging group ( @ sessions ) over @ weeks .


Psychiatric symptoms , neurocognitive functioning and social functioning assessments were evaluated at baseline and at @ weeks .


A two-way anova with neurocognitive rehabilitation and antipsychotic medication as factors revealed a significant interaction effect on motor speed .


Working memory and motor speed significantly improved in the RA group compared with the CA group .


We found no significant improvements between the CR group and the RR group .


A synergistic effect of neurocognitive rehabilitation and aripiprazole was observed as improvement of motor speed .


In patients treated with aripiprazole , neurocognitive rehabilitation appeared to improve working memory and motor speed .


Further studies of synergistic effects of neurocognitive rehabilitation and antipsychotic medication are necessary to verify these findings .


The progression of heart failure is affected by several factors , including chronic stimulation of the - adrenoceptor .


This clinical study was designed to measure the effects of thoracic epidural analgesia ( TEA ) on the plasma levels of norepinephrine ( NE ) , cAMP , and cGMP in patients with heart failure and assess the clinical implication of TEA .


Forty patients with heart failure were randomly assigned to TEA ( TEA plus standard care ) and control groups ( standard care ) .


The plasma concentrations of cAMP , cGMP , brain natriuretic peptide ( BNP ) , and NE were measured using ELISA before treatment , the second and fourth weeks of treatment .


The plasma concentrations of cAMP , cGMP , BNP , and NE in the TEA group were significantly reduced by the fourth week compared to their initial concentrations ( P < @ , for all parameters ) and the control group ( P < @ , P < @ , P < @ , and P < @ , respectively ) .


The values for left ventricular end diastolic diameter ( LVEDD ) , ejection fraction ( EF ) , and fractional shortening ( FS ) in the TEA group improved significantly compared to their initial values and the control group .


However , the changes in levels for these indices in the control group were no statistical significant compared to the initial levels .


TEA can effectively decrease the plasma concentrations of cAMP and cGMP and improve cardiac function in patients with heart failure .


The decreased levels of NE and cAMP occurred before the improvement in cardiac function , indicating that the abnormal epidural signal transduction can be corrected in patients with heart failure .


To examine the impact of a personal health record ( PHR ) on medication-use safety among older adults .


Online PHRs have potential as tools to manage health information .


We know little about how to make PHRs accessible for older adults and what effects this will have .


A PHR was designed and pretested with older adults and tested in a @-month randomized controlled trial .


After completing mailed baseline questionnaires , eligible computer users aged @ and over were randomized @:@ to be given access to a PHR ( n = @ ) or serve as a standard care control group ( n = @ ) .


Follow-up questionnaires measured change from baseline medication use , medication reconciliation behaviors , and medication management problems .


Older adults were interested in keeping track of their health and medication information .


A majority ( @ % ) logged into the PHR and used it , but only @ % used it frequently .


At follow-up , those randomized to the PHR group were significantly less likely to use multiple non-steroidal anti-inflammatory drugs-the most common warning generated by the system ( viewed by @ % of participants ) .


Compared with low/non-users , high users reported significantly more changes in medication use and improved medication reconciliation behaviors , and recognized significantly more side effects , but there was no difference in use of inappropriate medications or adherence measures .


PHRs can engage older adults for better medication self-management ; however , features that motivate continued use will be needed .


Longer-term studies of continued users will be required to evaluate the impact of these changes in behavior on patient health outcomes .


People with chronic heart failure ( HF ) suffer from numerous symptoms that worsen quality of life .


The CASA ( Collaborative Care to Alleviate Symptoms and Adjust to Illness ) intervention was designed to improve symptoms and quality of life by integrating palliative and psychosocial care into chronic care .


Our aim was to determine the feasibility and acceptability of CASA and identify necessary improvements .


We conducted a prospective mixed-methods pilot trial .


The CASA intervention included ( @ ) nurse phone visits involving structured symptom assessments and guidelines to alleviate breathlessness , fatigue , pain , or depression ; ( @ ) structured phone counseling targeting adjustment to illness and depression if present ; and ( @ ) weekly team meetings with a palliative care specialist , cardiologist , and primary care physician focused on medical recommendations to primary care providers ( PCPs , physician or nurse practioners ) to improve symptoms .


Study subjects were outpatients with chronic HF from a Veteran 's Affairs hospital ( n = @ ) and a university hospital ( n = @ ) .


Measurements included feasibility ( cohort retention rate , medical recommendation implementation rate , missing data , quality of care ) and acceptability ( an end-of-study semi-structured participant interview ) .


Participants were male with a median age of @ years .


One withdrew early and there were < @ % missing data .


Overall , @ % of @ collaborative care team medical recommendations were implemented .


All participants who screened positive for depression were either treated for depression or thought to not have a depressive disorder .


In the qualitative interviews , patients reported a positive experience and provided several constructive critiques .


The CASA intervention was feasible based on participant enrollment , cohort retention , implementation of medical recommendations , minimal missing data , and acceptability .


Several intervention changes were made based on participant feedback .


Because respiratory muscle function plays a strong role in exercise capacity and cardiopulmonary response to exercise , systematic training and measurement of respiratory muscle function should be considered in stroke patients .


The purpose of this study was to determine whether an individualized respiratory muscle training device combined with conventional physical therapy exercise can improve the pulmonary function and exercise capacity of stroke patients .


Twenty stroke patients were randomly assigned to an exercise group ( n = @ ) or a control group ( n = @ ) .


Over @ weeks , each group participated in exercise training interventions @ times per week .


In each session , the control group received basic exercise treatments for @ min , followed by an automated full-body workout for @ min .


The exercise group performed the same exercise regimen as the control group , as well as an additional respiratory muscle training regimen using a respiratory exercise device for @ min .


Pulmonary function of forced vital capacity ( FVC ) , forced expiratory volume at @ s ( FEV@ ) , FEV@/FVC , and peak expiratory flow ( PEF ) and exercise capacity of a @-min walking test and Shortness of Breath Modified Borg Dyspnea Scale ( SBMBDS ) scores were assessed before and after the training .


A significant intergroup difference was observed in the FVC , FEV@ , PEF , @MWT , and SBMBDS scores ( p < @ ) .


These findings suggest that exercise of the respiratory muscles using an individualized respiratory device had a positive effect on pulmonary function and exercise capacity and may be used for breathing rehabilitation in stroke patients .


Approximately , @-@ % of patients with gastro-esophageal reflux disease ( GERD ) experience persistent symptoms despite treatment with proton pump inhibitors ( PPIs ) .


These patients may have underlying dysmotility ; therefore , targeting gastric motor dysfunction in addition to acid inhibition may represent a new therapeutic avenue .


The aim of this study was to assess the pharmacodynamic effect of the prokinetic agent revexepride ( a @-HT@ receptor agonist ) in patients with GERD who have persistent symptoms despite treatment with a PPI .


This was a phase II , exploratory , multicenter , randomized , placebo-controlled , double-blind , parallel-group study in patients with GERD who experienced persistent symptoms while taking a stable dose of PPIs ( ClinicalTrials.gov identifier : NCT@ ) .


Patients were randomized to either revexepride ( @ mg , three times daily ) or matching placebo for @ weeks .


Reflux events and associated characteristics were assessed by pH/impedance monitoring and disease symptoms were assessed using electronic diaries and questionnaires .


In total , @ patients were enrolled in the study .


There were no significant differences between study arms in the number , the mean proximal extent or the bolus clearance times of liquid-containing reflux events .


Changes from baseline in the number of heartburn , regurgitation , and other symptom events were minimal for each treatment group and no clear trends were observed .


No clear differences were seen in reflux parameters between the placebo and revexepride groups .


The hands of hospital personnel are considered to be important for colonization and infection of patients with Candida spp .


The aim of this study was to evaluate the effectiveness of different hand disinfectants in reducing the carriage of Candida species on the hands of hospital personnel .


A controlled study was conducted at Duzce University School of Medicine Hospital .


Eighty hospital personnel were included in the trial .


Subjects were divided into @ groups according to hand hygiene procedures : group @ , hand rubbing with alcohol-based solution ; group @ , hand washing with @ % chlorhexidine gluconate ; group @ , hand washing with @ % povidone-iodine ; group @ , hand washing with plain soap and water .


The hands of all participants were tested by culture with the broth wash technique .


Hand carriage of Candida spp .


was lower in the @ % chlorhexidine gluconate group ( @ % , p = @ ) , in the @ % povidone-iodine group ( @ % , p = @ ) , and in the alcohol-based hand rub group ( @ % , p = @ ) compared to the group washing hands with plain soap and water ( @ % ) .


The use of hand disinfectant containing antimicrobial agents is more effective than hand washing with water and soap in reducing carriage of Candida on the hands of hospital personnel .


It is recommended that hospital personnel use an antimicrobial hand disinfectant in units where there is a high risk of Candida infection .


This study sought to examine the effect of targeted physical therapy with and without cranial nerve non-invasive neuromodulation ( CN-NINM ) , on the walking ability of people with MS who exhibited a dysfunctional gait .


We hypothesized that subjects who received electrical stimulation would have greater improvement than those who had a control device after a @-week intervention .


Gait disturbance is a common problem for people with multiple sclerosis ( MS ) .


Current management may include exercise , pharmacology , functional electrical stimulation , compensatory strategies , use of assistive devices , and implanted electrical devices .


We have developed an effective rehabilitative strategy using neuromodulation of the cranial nerves via electrical stimulation of the tongue to enhance the plasticity of the brain .


The study is a within-subject blinded randomized control design .


Twenty chronic MS subjects with an identified gait disturbance were assigned to either an active or control group .


Both groups completed a @-week intervention program using a standardized combination of exercise and a device that provided electrical stimulation to the tongue .


Those in the active group received electrical stimulation on the tongue that they could perceive .


Those in the control group used a device that did not provide a physiologically significant stimulus and was not perceivable .


Subjects were assessed with the Dynamic Gait Index ( DGI ) .


The DGI scores improved for both groups .


There were significant between-group differences , with the active group showing statistically greater improvement than the control group mean .


People with MS demonstrated improved gait with CN-NINM training in a pilot randomized controlled trial .


This study suggests that tongue-based neurostimulation may amplify the benefits of exercise for improving gait in people with chronic MS.


Higher-level gait disorder ( HLGD ) in older adults is characterized by postural instability , stepping dysrhythmicity , recurrent falls and progressive immobility .


Cognitive impairments are frequently associated with HLGD .


The aim of this study was to compare gait and cognitive performance before and after the use of rivastigmine in patients with HLGD , free from cognitive impairment or Parkinsonism .


Fifteen non-demented patients with HLGD ( age @ @ years ; @ women ; Mini-Mental State Examination -LSB- MMSE -RSB- @ @ ) received escalating doses of rivastigmine for @ weeks in an open-label , pilot study .


They were assessed before and after treatment ( week @ and week @ ) , and after a @-week washout period ( week @ ) .


Assessments included the Mindstreams computerized neuropsychological battery , Activities-specific Balance Confidence Scale , State-Trait Anxiety Inventory , Geriatric Depression Scale , Timed Up and Go ( TUG ) test , gait speed and stride time variability .


One-way multiple analysis of variance tests for repeated measures were used , and Pillai 's trace test was considered as robust to investigate significant differences .


The mean dose of rivastigmine during the @-@ week period was @ @ mg/day .


A positive effect was observed on the Mindstreams memory subscale and anxiety scores -LSB- Pillai 's trace : F ( @,@ ) = @ , p = @ ; and F ( @,@ ) = @ , p = @ , respectively , over the course of the study -RSB- as well as on mobility ( TUG test ) -LSB- Pillai 's trace : F ( @,@ ) = @ ; p = @ -RSB- , whereas gait speed and stride time variability did not change .


The use of relatively low-dose rivastigmine did not affect gait speed and stride time variability ; however , the general mobility and anxiety were improved .


These preliminary results warrant a larger , randomized , placebo-controlled study .


Accumulation of bacteria in the pharynx is one of the risk factors of pneumonia due to ventilation .


One of the methods of prevention from accumulation of bacteria in the pharynx is the use of oral solutions .


Chlorhexidine is considered as the gold standard , but it has various side effects .


Present study was aimed to determine and compare anti-bacterial effects of the chlorhexidine gluconate @ % , herbal mouthwash of Matrica ( chamomile extracts ) @ % , PersicaTM @ % and normal saline in intensive care unit patients .


In this double blind randomized clinical trial , @ patients who were admitted in ICU divided into four groups of @ patients each one .


Researchers applied PersicaTM to group one , chlorhexidine gluconate mouth wash @ % to group two and third group received Matrica , finally in the control group , normal saline were used .


In order to culturing of Staphylococcus aureus and S. pneumoniae , salivary samples were obtained without any stimulation after six minimums oral rinsing .


The data were processed in SPSS@ software and analyzed by appropriate statistical tests .


Decreased rate of bacterial colonies after intervention in the whole four groups was significant ( p < @ ) .


The mouth wash of chlorhexidine ( p < @ ) , PersicaTM ( p : @ ) and Matrica ( p : @ ) had a significant antibacterial effect on S. aureus and S. pneumoniae ( p < @ ) .


Herbal oral mouthwash of persica and matrica has the effect on S. pneumoniae and S. aureus of oropharynx area in mechanically ventilated patients .


However , there is a need for further research to be considered as an alternative to chlorhexidine for prevention of VALP in ICU patients .


Preliminary evaluation of efficacy and safety of uzara use in treatment of moderate and severe primary dysmenorrhea in comparison to ibuprofen .


This randomized , comparative two way cross-over study comprised @ single female students at Faculty of Medicine , Ain Shams University , Egypt , aged @-@ years with moderate ( n = @ ) or severe ( n = @ ) primary dysmenorrhea .


Participants were randomized to take either uzara ( @ mg/@ hours for two doses , then @ mg/@ hours ) then ibuprofen ( @ mg/@ hours ) in two subsequent cycles or vice versa .


The pain intensity , using VAS , was recorded immediately before taking the medication ( @ hour ) and after @ , @ , @ , @-@ , @-@ hours .


Main outcome measures included effectiveness of pain relief defined as drop of VAS to @ or less , patient 's global evaluation of the drug , absence from school , the use of a rescue medication , and , in those who continued the treatment , the pain intensity difference ( PID ) at different points after start of medication and its sum ( SPID ) .


Uzara was comparably effective to ibuprofen ( @ % vs. @ % of cycles ; respectively ) , with comparable rates of effectiveness on global evaluation ( being around @ % for either drug ) , and rates of school absences ( @ % vs. @ % ; respectively ) .


The need for rescue medication was different ( @ % and @ % ; respectively ) , albeit with no statistical significance .


The means of PID at different time points and SPID were comparable , with significantly lower average mean of VAS scores compared to that felt with no medication ( @ vs. @ , p < @ ) .


Side effects were less with uzara than ibuprofen ( @ % vs. @ % , p < @ ) .


Uzara might be as effective as ibuprofen in management of primary dysmenorrhea but with less side effects .


These findings need to be confirmed by a properly designed trial with a larger sample size .


We evaluated the efficacy and safety of add-on treatment with a @-adrenoceptor agonist ( mirabegron ) for overactive bladder symptoms remaining after @-blocker ( tamsulosin ) treatment in men with benign prostatic obstruction .


Patients with benign prostatic obstruction with urinary urgency at least once per week and a total OABSS of @ or more points after @ or more weeks of treatment with tamsulosin were enrolled in the study .


They were randomly allocated to receive @ mg tamsulosin daily or @ mg tamsulosin and @ mg mirabegron daily for @ weeks .


The primary end point was change in total OABSS .


Safety assessments included change in post-void residual urine volume and adverse events .


From January @ through September @ a total of @ patients were randomized .


Of these patients @ completed the protocol treatment .


In the full analysis set the change in total OABSS during the treatment period was significantly greater in the combination group than in the monotherapy group ( -@ vs -@ , p = @ ) .


The changes in scores for urinary urgency , daytime frequency , International Prostate Symptom Score storage symptom subscore and quality of life index at @ weeks were significantly greater in the combination group .


The change in post-void residual urine volume was significantly greater in the combination group .


Although @ patients experienced adverse events in the combination group , urinary retention was observed in only @ patient .


Combined tamsulosin and mirabegron treatment is effective and safe for patients with benign prostatic obstruction who have overactive bladder symptoms after tamsulosin monotherapy .


To report on oral-health-related characteristics , beliefs , and behaviours among participants in a randomised control trial of an intervention to prevent early childhood caries ( ECC ) among Mori children , and to determine whether there were any systematic differences between the intervention and control groups at baseline .


Baseline measurements from a randomised control trial ( involving @ pregnant Mori women allocated randomly to either Intervention or Delayed groups ) which is currently underway .


The rohe ( tribal area ) of Waikato-Tainui .


Self-report information collected on sociodemographic characteristics , pregnancy details , self-reported general and oral health and health-related behaviours , and oral health beliefs .


Other than those in the Delayed group being slightly older , on average , there were no significant differences between the two groups .


Some @ % were expecting their first child .


Most reported good health ; @ % were current smokers , and @ % had never smoked .


Only @ % were current users of alcohol .


Almost all were dentate , and @ % described their oral health as fair or poor .


One in six had had toothache in the previous year ; @ % reported being uncomfortable about the appearance of their teeth , and @ % reported difficulty in eating .


Dental service-use was relatively low and symptom-related ; @ % needed to see a dentist .


Overall , most of the sample believed that it was important to avoid sweet foods , visit dentists and to brush the teeth , while about half thought that using fluoride toothpaste and using floss were important .


Some @ % felt that drinking fluoridated water was important .


Oral-health-related fatalism was apparent , with @ % believing that most people usually get dental problems , @ % believing that most people will need extractions at some stage , and that most children eventually get dental caries .


Mothers ' important role in nurturing the well-being of the young child includes the protection and maintenance of the growing child 's oral health ( or ukaipo niho ) .


The findings provide important insights into Mori mothers ' oral health knowledge , beliefs and practices .


Several therapies have been used in the treatment of chronic low back pain ( LBP ) , including various exercise strategies and spinal manipulative therapy ( SMT ) .


A common belief is that spinal motion changes in particular ways in direct response to specific interventions , such as exercise or spinal manipulation .


The purpose of this study was to assess changes in lumbar region motion for more than @ weeks by evaluating four motion parameters in the sagittal plane and two in the horizontal plane in LBP patients treated with either exercise therapy or spinal manipulation .


Secondary analysis of a subset of participants from a randomized clinical trial .


One hundred ninety-nine study participants with LBP of more than @ weeks ' duration who had spinal motion measures obtained before and after the period of intervention .


Lumbar region spinal kinematics sampled using a six-degree-of-freedom instrumented spatial linkage system .


Trained therapists collected regional lumbar spinal motion data at baseline and @ weeks of follow-up .


The lumbar region spinal motion data were analyzed as a total cohort and relative to treatment modality ( high dose , supervised low-tech trunk exercise , SMT , and a short course of home exercise and self-care advice ) .


The study was supported by grants from Health Resources and Services Administration , Danish Agency for Science Technology and Innovation , Danish Chiropractors Research Foundation , and the University of Southern Denmark .


No conflicts of interest reported .


For the cohort as a whole , lumbar region motion parameters were altered over the @-week period , except for the jerk index parameter .


The group receiving spinal manipulation changed significantly in all , and the exercise groups in half , the motion parameters included in the analysis .


The spinal manipulation group changed to a smoother motion pattern ( reduced jerk index ) , whereas the exercise groups did not .


This study provides evidence that spinal motion changes can occur in chronic LBP patients over a @-week period and that these changes are associated with the type of treatment .


To propose a rehabilitation protocol able to produce immediate and long-term beneficial effects on level of disability and overall performance in ADLs .


Forty-one FM patients were randomized to an exercise and educational-behavioral programme group ( experimental group , EG = @ ) or to a control group ( CG = @ ) .


Each subject was evaluated before , at the end ( T@ ) , and after @ months ( T@ ) from the conclusion of the rehabilitation treatment using the Fibromyalgia Impact Questionnaire ( FIQ ) , the visual analogue scale ( VAS ) , the Health Assessment Questionnaire ( HAQ ) , the fatigue severity scale ( FSS ) , the @-minute walking test ( @MWT ) , tender points count ( TPC ) , and spinal active range of motion .


The exercise protocol included @ sessions consisting in self-awareness , stretching , strengthening , spine flexibility , and aerobic exercises , which patients were subsequently educated to perform at home .


The two groups were comparable at baseline .


At T@ , the EG showed a positive trend in FIQ , VAS , HAQ , and FSS scales and significant improvement in @MWT and in most spinal active range of motion measurements ( P between @ and @ ) .


The positive results were maintained at the follow-up .


The proposed programme was well tolerated and produced immediate and medium-term beneficial effects improving function and strain endurance .


This trial is registered with DRKS@ on DRKS .


An intracuff pressure of @cm H@ O in the adult-sized laryngeal mask airway Supreme has been recommended to obtain a higher oropharyngeal leak pressure ( OLP ) .


However , the intracuff pressure for the higher OLP in the pediatric laryngeal mask airway Supreme could be different from that in the adult-sized laryngeal mask airway Supreme .


Thus , we measured and compared OLP at three intracuff pressures of @ , @ , and @cm H@ O in the pediatric laryngeal mask airway Supreme .


This study was designed as a randomized crossover study and enrolled @ children , aged @-@months and @-@kg in weight .


After insertion of the laryngeal mask airway Supreme , oropharyngeal leak pressure ( OLP ) was measured at intracuff pressures of @ , @ , and @cm H@ O according to one of six sequences produced on the basis of @ Williams crossover design .


During the intraoperative period , the laryngeal mask airway Supreme was maintained using the last intracuff pressure of the allocated sequence .


The intraoperative and postoperative complications were compared among three maintenance intracuff pressures .


OLP at the intracuff pressure of @cm H@ O was significantly higher than that of @cm H@ O ( @ vs @ cm H@ O , P = @ ) and was comparable with that of @cm H@ O ( @ vs @ cm H@ O , P = @ ) .


There were no significant differences of intraoperative and postoperative complications among the three maintenance intracuff pressures .


Our results suggest that the use of an intracuff pressure of @cm H@ O in pediatric laryngeal mask airway Supreme provides a higher OLP compared with @cm H@ O.


Experimental and clinical pain studies are conflicting regarding whether individuals report heightened or dampened pain sensitivity in the presence of other men or women .


In the present preliminary study , two small medical record reviews of patients admitted for emergency care were conducted to examine the possibility that patients may report differential pain intensity to male and female health care examiners .


The study also sought to determine whether these effects are moderated by and , thus , only detectable by examining patients at different pain ( debilitation ) levels .


Pain intensity scores were extracted from two medical record reviews of patients admitted for emergency care ( n = @ and n = @ , respectively ) .


Pain intensity was measured using an @-point numerical scale during standard triage assessments and the sex of the examiner was recorded .


Mean pain scores reported to male and female emergency staff did not differ in either set of medical records .


However , when patients were split between low and high pain levels , male patients reported higher pain scores to male practitioners when experiencing relatively low pain levels , and both male and female patients reported higher pain scores to female practitioners when experiencing relatively high pain levels .


The statistical magnitudes of these effects were large , suggesting that this phenomenon may be a pervasive feature in clinical settings and experimental pain studies .


These preliminary findings warrant larger-scale investigations of social contextual influences on patient pain reports , which are necessary for creating more standardized protocols for reliably assessing and treating patient pain experiences .


To compare the effect of adding canrenone or hydrochlorothiazide ( HCTZ ) to valsartan/amlodipine combination on urinary albumin excretion ( UAE ) in microalbuminuric type @ diabetic hypertensives .


After a @-week placebo period and after @ weeks of valsartan @ mg plus amlodipine @ mg combination , @ patients whose blood pressure ( BP ) was not controlled ( > @/@ mmHg ) were randomized to canrenone @ mg or HCTZ @ mg in addition to the previous therapy for @ weeks .


After the first @ weeks of triple therapy , canrenone or HCTZ doses were doubled in the patients whose BP was yet uncontrolled .


At the end of each period ( placebo , dual combination and triple combination therapy ) , clinic and ambulatory BP measurements were recorded and @ h UAE was evaluated .


Both triple combinations produced greater clinical and ambulatory BP reduction than dual therapy , with no difference between the two groups .


UAE was reduced by both regimens , but the decrease associated with canrenone add-on therapy was more pronounced .


At week @ , UAE decreased by @ % in the canrenone group and by @ % in the HCTZ group ( p < @ ) .


These findings indicate that , despite similar BP-lowering effect , the addition of canrenone to valsartan/amlodipine combination was more effective in reducing UAE than HCTZ addition .


To evaluate the effect of early aqueous suppressant treatment on Ahmed glaucoma valve ( AGV ) surgery outcomes .


Randomized clinical trial .


Ninety-four eyes of @ patients with refractory glaucoma .


After AGV implantation , @ cases ( group @ ) received topical timolol-dorzolamide fixed-combination drops twice daily when intraocular pressure ( IOP ) exceeded @ mmHg , whereas @ controls ( group @ ) received conventional stepwise treatment when IOP exceeded target pressure .


Main outcome measures included IOP and success rate ( @ mmHg < IOP < @ mmHg and IOP reduction of at least @ % from baseline ) .


Other outcome measures included best-corrected visual acuity , complications , and hypertensive phase frequency .


Groups @ and @ were both followed up for a mean of @ and @ weeks , respectively ( P = @ ) .


Mixed model analysis revealed a significantly greater IOP reduction in group @ at all intervals ( P < @ ) .


At @ year , the cases exhibited a significantly higher success rate ( @ % vs. @ % ; P = @ ) and reduced hypertensive phase frequency ( @ % vs. @ % ; P < @ ) .


Early aqueous suppressant treatment may improve AGV implantation outcomes in terms of IOP reduction , success rate , and hypertensive phase frequency .


To assess clinician attitudes and experiences in Health eHearts , a quality recognition and financial incentive program using health information technology .


Survey of physicians .


A survey was administered to @ lead clinicians at each participating practice .


Survey domains included clinicians ' experiences and attitudes toward the selected clinical quality measures focused on cardiovascular care , use of electronic health records ( EHRs ) , technical assistance visits , quality measurement reports , and incentive payments .


Responses were compared across groups of practices receiving financial incentives with those in the control ( no financial rewards ) .


Survey response rate was @ % .


The majority of respondents reported receiving and reviewing the quality reports ( @ % ) , agreed with the prioritization of measures ( @ % ) , and understood the information given in the quality reports ( @ % ) .


Over half of the respondents had a quality improvement visit ( @ % ) , with incentive clinicians more likely to have had a visit compared with the control group ( @ % vs @ % , P = @ ) .


The incentive group respondents ( @ % ) were more likely to report using clinical decision support system alerts than control group respondents ( @ % , P = @ ) .


Clinicians in both incentive and control groups reported positive experiences with the program .


No differences were detected between groups regarding agreement with selected clinical measures or their relevance to the patient population .


However , clinicians in the incentive group were more likely to review quarterly performance reports and access quality improvement visits .


Incentives may be used to further engage clinicians operating in small independently owned practices to participate in quality improvement activities .


Selenium is found in soils and is essential for human antioxidant defense and immune function .


In Malawi , low soil selenium and dietary intakes coupled with low plasma selenium concentrations in HIV infection could have negative consequences for the health of HIV-infected mothers and their exclusively breastfed infants .


We tested the effects of lipid-based nutrient supplements ( LNS ) that contained @ times the Recommended Dietary Allowance of sodium selenite and antiretroviral drugs ( ARV ) on maternal plasma and breast-milk selenium concentrations .


HIV-infected Malawian mothers in the Breastfeeding , Antiretrovirals , and Nutrition study were randomly assigned at delivery to receive : LNS , ARV , LNS and ARV , or a control .


In a subsample of @ mothers and their uninfected infants , we measured plasma and breast-milk selenium concentrations at @ or @ ( depending on the availability of infant samples ) and @ wk postpartum .


Overall , mean ( SD ) maternal ( range : @ @ to @ @ g/L ) and infant ( @ @ to @ @ g/L ) plasma selenium concentrations increased , whereas breast-milk selenium concentrations declined ( @ @ to @ @ g/L ) from @ or @ to @ wk postpartum ( all P < @ ) .


Compared with the highest baseline selenium tertile , low and middle tertiles were positively associated with a change in maternal plasma or breast-milk selenium from @ or @ to @ wk postpartum ( both P < @ ) .


With the use of linear regression , we showed that LNS that contained selenium and ARV were not associated with changes in maternal plasma and breast-milk selenium , but maternal selenium concentrations were positively associated with infant plasma selenium at @ or @ and @ wk postpartum ( P < @ ) regardless of the study arm .


Selenite supplementation of HIV-infected Malawian women was not associated with a change in their plasma or breast-milk selenium concentrations .


Future research should examine effects of more readily incorporated forms of selenium ( ie , selenomethionine ) in HIV-infected breastfeeding women .


Skin and skin-structure infections are common in ambulatory settings .


However , the efficacy of various antibiotic regimens in the era of community-acquired methicillin-resistant Staphylococcus aureus ( MRSA ) is unclear .


We enrolled outpatients with uncomplicated skin infections who had cellulitis , abscesses larger than @ cm in diameter ( smaller for younger children ) , or both .


Patients were enrolled at four study sites .


All abscesses underwent incision and drainage .


Patients were randomly assigned in a @:@ ratio to receive either clindamycin or trimethoprim-sulfamethoxazole ( TMP-SMX ) for @ days .


Patients and investigators were unaware of the treatment assignments and microbiologic test results .


The primary outcome was clinical cure @ to @ days after the end of treatment .


A total of @ patients were enrolled ( @ in the clindamycin group and @ in the TMP-SMX group ) , including @ children ( @ % ) .


One hundred sixty patients ( @ % ) had an abscess , @ ( @ % ) had cellulitis , and @ ( @ % ) had mixed infection , defined as at least one abscess lesion and one cellulitis lesion .


S. aureus was isolated from the lesions of @ patients ( @ % ) ; the isolates in @ ( @ % ) of these patients were MRSA .


The proportion of patients cured was similar in the two treatment groups in the intention-to-treat population ( @ % in the clindamycin group and @ % in the TMP-SMX group ; difference , -@ percentage points ; @ % confidence interval -LSB- CI -RSB- , -@ to @ ; P = @ ) and in the populations of patients who could be evaluated ( @ patients ; @ % in the clindamycin group and @ % in the TMP-SMX group ; difference , -@ percentage points ; @ % CI , -@ to @ ; P = @ ) .