At m43 , 8-IM , 5-IM , and 4-IM group GMCs were superior to the 8-SQ group .


Solicited injection site AEs occurred at lower proportions in the IM group compared to SQ. .


Route of administration did not influence the occurrence of systemic AEs .


A 3 dose IM priming schedule with doses administered at m0 , m1 , and m6 elicited long term immunological responses and robust immunological memory that was efficiently stimulated by a single booster vaccination at 42 months .


A priming series of 3 intramuscular doses administered at m0 , m1 , and m6 with a triennial booster was non-inferior to more complex schedules for achieving antibody response .


To compare acute normovolemic hemodilution versus low central venous pressure strategy versus conventional fluid management in reducing intraoperative estimated blood loss , hematocrit drop and need for blood transfusion in patients undergoing radical retropubic prostatectomy under general anesthesia .


Patients undergoing radical retropubic prostatectomy under general anesthesia were randomized to conventional fluid management , acute normovolemic hemodilution or low central venous pressure ( 5mmHg ) .


Treatment effects on estimated blood loss and hematocrit change were tested in multivariable regression models accounting for surgeon , prostate size , and all two-way interactions .


Ninety-two patients completed the study .


Estimated blood loss ( meanSD ) was significantly lower with low central venous pressure ( 706362ml ) compared to acute normovolemic hemodilution ( 1103635ml ) and conventional ( 1051714ml ) groups ( p = 0.0134 ) .


There was no difference between the groups in need for blood transfusion , or hematocrit drop from preoperative values .


The multivariate model predicting estimated blood loss showed a significant effect of treatment ( p = 0.0028 ) and prostate size ( p = 0.0323 ) , accounting for surgeon ( p = 0.0013 ) .


In the model predicting hematocrit change , accounting for surgeon difference ( p = 0.0037 ) , the treatment effect depended on prostate size ( p = 0.0007 ) with the slope of low central venous pressure differing from the other two groups .


Hematocrit was predicted to drop more with increased prostate size in acute normovolemic hemodilution and conventional groups but not with low central venous pressure .


Limitations include the inability to blind providers to group assignment , possible variability between providers in estimation of blood loss , and the relatively small sample size that was not powered to detect differences between the groups in need for blood transfusion .


Maintaining low central venous pressure reduced estimated blood loss compared to conventional fluid management and acute normovolemic hemodilution in patients undergoing radical retropubic prostatectomy but there was no difference in allogeneic blood transfusion between the groups .


Vitamin D deficiency is associated with reduced lung function .


Cathelicidin , an antimicrobial peptide regulated by vitamin D , plays a role within the innate immune system .


The association of cathelicidin with lung function decrement and respiratory infection is undefined .


We determined the independent relationship of cathelicidin with lung function .


In a cross-sectional analysis of 650 participants in an urban observational cohort with high smoking prevalence , plasma 25 ( OH ) - vitamin D and cathelicidin levels were measured from stored samples obtained within 6 months of spirometry study visits .


Multivariable linear regression was used to determine the independent association between low cathelicidin ( defined as the lowest quartile of the cohort ) and absolute forced expiratory volume in 1 second ( FEV1 ) .


The mean age of the cohort was 49 years ; 91 % were black , 35 % female and 41 % HIV-infected .


Participants with low cathelicidin had a 183 mL lower FEV1 compared to higher cathelicidin ( p = 0.009 ) ; this relationship was maintained ( 115 ml lower ; p = 0.035 ) after adjusting for demographics , BMI , and smoking .


Neither HIV serostatus , heavy smoking history , nor 25 ( OH ) - vitamin D levels were associated with cathelicidin levels .


Participants with low cathelicidin had a greater prevalence of prior bacterial pneumonia ( 21 % versus 14 % ; p = 0.047 ) .


Inclusion of pneumonia in adjusted models did not substantially reduce the FEV1 decrement observed with low cathelicidin ( 104 mL lower FEV1 ; p = 0.05 ) .


Lung function decrements associated with low cathelicidin were greatest among individuals with lower 25 ( OH ) - vitamin D levels .


In a cohort at risk for airflow obstruction , low cathelicidin was independently associated with lower FEV1 .


These clinical data support a mechanistic link between 25 ( OH ) - vitamin D deficiency and lung function impairment , independent of pneumonia risk .


We compared the outcome of retrograde intrarenal surgery monotherapy vs shock wave lithotripsy for stones 10 to 20 mm in preschool children .


This prospective study included 60 children with a mean SD age of 2.4 1.3 years .


Patients were randomly divided into 2 groups .


Group 1 underwent shock wave lithotripsy and group 2 underwent retrograde intrarenal surgery as monotherapy .


Retrograde intrarenal surgery was started using a 7.5 Fr semirigid ureteroscope ( Storz ) and the holmium laser , and completed by the Flex X2 flexible ureterorenoscope .


A ureteral access sheath was not used and only hydrodilatation was performed .


Patients were evaluated preoperatively by ultrasound and plain abdominopelvic x-ray .


Followup was 3 months .


The stone-free rate after a single session treatment was 70 % and 86.6 % in groups 1 and 2 , respectively .


Mean operative time was 27.9 3.5 and 40 7.8 minutes , mean fluoroscopy exposure time was 60 42 and 50 35 seconds , and mean hospital stay was 6 2 and 12 8 hours , respectively .


No major complication occurred in either group and no child in either group received blood transfusion .


Nine group 1 patients needed a second shock wave lithotripsy session , of whom 2 required a third session .


At 3 months the overall stone-free rate was 93.3 % and 96.6 % in groups 1 and 2 , respectively .


Retrograde intrarenal surgery is an option for treating medium sized renal stones in preschool children with results comparable to those of shock wave lithotripsy and a safe short-term outcome .


Data on the potent pleiotropic extraskeletal effects of vitamin D have renewed interest in its use in selected populations , including patients with chronic kidney disease , but the available data are still insufficient to make recommendations .


This study assessed the long-term effect of small cholecalciferol doses on serum vitamin D , parathormone ( PTH ) , and bone mineral density ( BMD ) in hemodialysis patients .


Nineteen patients with serum 25 ( OH ) D < 20 ng/mL were randomized into cholecalciferol ( 2000 IU 3/week ) and no-treatment groups , then observed for 1 year .


Patients with hypercalcemia , hyperphosphatemia , and receiving vitamin D/calcimimetics were excluded .


Serum 25 ( OH ) D , 1,25 ( OH ) 2D , PTH , and alkaline phosphatase activity were examined every 2 months and BMD was measured before and after the study .


We observed normalization of serum 25 ( OH ) D with an increase in medians from 11.3 to 44.9 ng/mL ( P = 0.02 ) in the cholecalciferol group and no change in the controls ( P < 0.001 ) .


Simultaneously , median serum 1,25 ( OH ) 2D increased from 18.2 to 43.1 pmol/L ( P = 0.02 ) in the cholecalciferol group and from 10.6 to 21.2 pmol/L ( P = 0.02 ) in controls ( P = 0.013 ) .


The treatment was associated with a small increase in serum calcium , but serum phosphate , PTH , alkaline phosphatase , and BMD remained unchanged in both groups .


Oral cholecalciferol at a dose of 2000 IU/3/week is an effective and safe way to treat vitamin D deficiency in hemodialysis patients , leading to a significant increase in serum 1,25 ( OH ) 2D .


However , it was insufficient to suppress the activity of parathyroid glands or to significantly change BMD .


Specific parental behaviors and cognitions are associated with child anxiety .


Studies informing us of the directionality of the associations are lacking .


We investigated the effect of parental involvement in children 's anxiety treatment on parental behaviors and cognitions .


Children ( N = 54 , 7-12 years ) and parents were randomly allocated to different treatment groups ( involved , not involved ) .


Observed behavior , self-reported behavior and cognitions were assessed separately for mothers and fathers at pre - , posttreatment and follow-up .


There were no differences over time for self-reported parental efficacy and observed negativity , but self-reported autonomy granting increased for both groups over time .


Differential effects were found between groups for observed paternal over-involvement ( fathers involved in treatment showed a more rapid decrease ) and self-reported maternal autonomy-granting ( non-involved mothers showed a greater increase ) .


Our findings suggest that child anxiety significantly influences parental behaviors and cognitions .


Child therapy may successfully change the family system .


To observe the effect of two different ways of subglottic secretion drainage on the incidence of ventilator-associated pneumonia .


A total of 149 patients receiving mechanical ventilation from October 2007 to February 2010 in our hospital were enrolled in our study .


According to the random number table , they were divided into 3 groups : a control group ( 47 ) , a intermittent drainage group ( 54 ) , and a continuous drainage group ( 48 ) .


There was no significant difference in APACHE II score before intubation in the patients of the 3 groups .


Conventional treatment and care was performed in the control group , while subglottic rinse was performed every 4 h in the intermittent drainage group and continuous aspiration in the continuous drainage group .


The incidence and mortality of ventilator-associated pneumonia were compared among groups within 30 days after intubation .


The tolerance and complications were observed .


The incidence rate of early onset ventilator-associated pneumonia in the intermittent drainage group ( 13.0 % ) and the continuous drainage group ( 14.6 % ) was significantly lower than that in the control group ( 40.4 % ) , and the difference was statistically significant ( ( 2 ) = 9.914 , 7.978 ;P = 0.002,0.005 ) , but there was no difference between the former 2 groups ( ( 2 ) = 0.056 ; P = 0.812 ) .


There was no significant difference in the incidence of late-onset ventilator-associated pneumonia or mortality among groups ( P > 0.05 ) .


Good tolerance of the 2 methods was observed .


Subglottic secretion drainage by both the intermittent and the continuous methods can efficiently prevent early onset ventilator-associated pneumonia .


Compared with nonaerated , isocaloric controls , aerated foods can reduce appetite throughout an entire dieting day .


Increased gastric volumes and delayed emptying are possible but unexplored mechanisms .


We tested the hypothesis that aerated drinks ( foams ) of differing gastric stability would increase gastric distension and reduce appetite compared with a control drink .


In a randomized , balanced , crossover trial , 18 healthy male participants consumed the following 3 skimmed-milk-based test products ( all 110 kcal ) : 2 drinks aerated to foams by whipping ( to 490 mL ) , one drink that was stable in the stomach [ stable foam ( SF ) ] , and one drink that was less stable in the stomach [ less-stable foam ( LSF ) ] , and a nonaerated drink [ liquid control ( LC ) ; 140 mL ] .


Over 4 h , stomach contents ( foam , air , and liquid ) were imaged using magnetic resonance imaging ( MRI ) , and self-reported appetite ratings were collected and quantified by the area under the curve or time to return to baseline ( TTRTB ) .


Compared with the LC , both foams caused significantly increased gastric volumes and reduced hunger ( all P < 0.001 ) .


Compared with the LSF , SF further produced a significantly slower decrease in the total gastric content ( P < 0.05 ) and foam volume ( P < 0.0001 ) and a longer TTRTB ( 197 compared with 248 min , respectively ; P < 0.05 ) , although the hunger AUC was not statistically different .


Results for other appetite scales were similar .


With this MRI trial , we provide novel insights on the gastrointestinal behavior of aerated drinks by measuring separate volumes of foam , liquid , and air layers in the stomach .


Appetite suppression induced by foams could largely be explained by effects on gastric volumes and emptying , which may be further enhanced by foam stability .


This trial was registered at clinicaltrials.gov as NCT01690182 .


Casein is considered a slowly digestible protein compared with whey protein , and this may cause differences in hormone responses and the kinetics of delivering amino acids into the circulation .


We investigated whether postprandial plasma hormone and metabolite responses were different when bovine casein or whey protein was co-administered with carbohydrates in healthy and prediabetic adults .


White healthy male adults ( n = 15 ) and white , well-defined male and female prediabetic adults ( n = 15 ) received test drinks randomly on 3 different occasions at least 2 d apart which contained 50 g of maltodextrin19 ( MD19 ) alone or in combination with 50 g of whey protein isolate ( WPI ) or 50 g of sodium caseinate ( SC ) .


Blood samples were collected over a 240-min time period and were analyzed for hormone profiles and defined metabolites .


No evidence was found that gastric emptying was different between the 2 protein drinks .


Both proteins increased peak plasma insulin concentrations in prediabetic persons by 96 % compared with MD19 ( each , P < 0.05 ) , which was accompanied by a reduction of peak venous blood glucose by 21 % ( each , P < 0.0001 ) without a difference between the 2 proteins .


Peak plasma glucagon concentrations increased by 101 % in both groups after the protein drinks ( P < 0.05 ) .


The WPI drink also increased peak plasma glucose-dependent insulinotropic polypeptide concentrations in healthy volunteers by 56 % ( P < 0.01 ) .


Differences in plasma metabolite concentrations in volunteers could be attributed exclusively to the differences in the amino acid composition of the 2 proteins ingested .


The WPI and the SC drinks similarly reduced postprandial glucose excursions when ingested with carbohydrates in healthy and prediabetic volunteers .


Under our experimental conditions , however , no evidence was found that gastrointestinal processing of the 2 protein varieties differed substantially .


This trial was registered at clinicaltrials.gov as DRKS00005682 .


To explore the effects of statins upon bone mineral density ( BMD ) and bone metabolic markers in postmenopausal women with hypercholesterolemia .


A prospective study was conducted for 100 women receiving treatment from January 2011 to August 2012 and meeting the inclusion criteria of osteopenia or osteoporosis with hypercholesterolemia postmenopausal .


They were randomly divided into treatment group on atorvastatin 10 mg once daily and control group .


The parameters of lumbar BMD , bone resorption markers of type I collagen cross-linked C-telopeptide ( CTX ) , bone synthesis markers procollagen type I N-terminal peptide ( PINP ) were compared between two groups after half a year and one year .


There was an upward trend of lumbar spine BMD and PINP in the treatment group at half a year and one year compared with the control group .


And two groups had significant difference ( P < 0.05 ) .


Although two groups had no significant difference in all parameters at half a year , the values of lumbar spine BMD and PINP were higher in the treatment group at one year than the control group .


Two groups had significant difference ( P < 0.05 ) .


Statins can help maintain or increase bone mass of hypercholesterolemic menopausal women through promoting bone synthesis .


Feedback from active locomotor muscles contributes to the exercise pressor response in healthy humans , and is thought to be more prominent in heart failure ( HF ) .


The purpose of this study was to examine the influence of metaboreflex stimulation on arterial pressure in HF .


Eleven HF patients ( 51 5 years , New York Heart Association Class I/II , left ventricular ejection fraction 32 3 % ) and 11 controls ( 42 3 years ) were recruited .


Participants completed two exercise sessions on separate days : ( 1 ) symptom limited graded exercise test ; and ( 2 ) constant work rate cycling ( 60 % peak oxygen consumption , VO2 ) for 4 minutes with 2 minutes passive recovery .


Recovery was randomized to normal or locomotor muscle regional circulatory occlusion ( RCO ) .


Mean arterial pressure ( MAP ) , systolic pressure ( SBP ) , diastolic pressure , heart rate ( HR ) and VO2 were measured at rest , end-exercise and recovery .


O2 pulse ( VO2/HR ) and the rate pressure product ( RPP = HR SBP ) were calculated .


In response to RCO , mean arterial pressure and SBP increased in HF compared with CTLs ( 6.8 5.8 % vs -3.0 7.8 % , P < .01 and 3.4 6.4 % vs -12.7 10.4 % , P < .01 , respectively ) , with no difference in diastolic pressure ( P = .61 ) .


HF patients had a smaller reduction in HR and RPP , but also displayed a larger decrease in O2 pulse consequent to locomotor metaboreflex stimulation ( P < .05 , for all ) .


RCO resulted in a markedly increased pressor response in HF relative to controls , due primarily to an increase of SBP and attenuated cardiac recovery as noted by the persistent elevation in HR .


The most common modality used to address acute inflammation is cryotherapy .


Whereas pain decreases with cryotherapy , evidence that changes occur in perfusion of skeletal muscle is limited .


We do not know whether ice attenuates the increases in perfusion associated with acute inflammation .


To examine the effects of repeated applications of ice bags on perfusion of the gastrocnemius muscle after an eccentric exercise protocol .


Controlled laboratory study .


Laboratory .


Eighteen healthy participants ( 3 men , 15 women ; age = 22.2 2.2 years , height = 166.0 11.9 cm , mass = 69.4 25.0 kg ) .


To induce eccentric muscle damage , participants performed 100 unilateral heel-lowering exercises off a step to the beat of a metronome .


A randomized intervention ( cryotherapy , sham , control ) was applied to the exercised lower extremity immediately after the protocol and again at 10 , 24 , and 34 hours after the protocol .


Baseline perfusion measurements ( blood volume , blood flow , and blood flow velocity ) were taken using contrast-enhanced ultrasound of the exercised leg .


Perfusion was reassessed after the first intervention and 48 hours after the protocol as percentage change scores .


Pain was measured with a visual analog scale at baseline and at 10 , 24 , 34 , and 48 hours after the protocol .


Separate repeated-measures analyses of variance were used to assess each dependent variable .


We found no interactions among interventions for microvascular perfusion .


Blood volume and blood flow , however , increased in all conditions at 48 hours after exercise ( P < .001 ) , and blood flow velocity decreased postintervention from baseline ( P = .041 ) .


We found a time-by-intervention interaction for pain ( P = .009 ) .


Visual analog scale scores were lower for the cryotherapy group than for the control group at 34 and 48 hours after exercise .


Whereas eccentric muscle damage resulted in increased blood flow , ice did not decrease muscle perfusion 48 hours after exercise .


Therefore , ice does not seem to decrease muscle perfusion when blood flow is elevated , as it would be during inflammation .


Stimulant medications , such as methylphenidate ( MPH ) , improve the academic performance of children with attention-deficit hyperactivity disorder ( ADHD ) .


However , the mechanism by which MPH exerts an effect on academic performance is unclear .


We examined MPH effects on math performance and investigated possible mediation of MPH effects by changes in time on-task , inhibitory control , selective attention , and reaction time variability .


Children with ADHD aged 7 to 11 years ( N = 93 ) completed a timed math worksheet ( with problems tailored to each individual 's level of proficiency ) and 2 neuropsychological tasks ( Go/No-Go and Child Attention Network Test ) at baseline , then participated in a 4-week , randomized , controlled , titration trial of MPH .


Children were then randomly assigned to their optimal MPH dose or placebo for 1 week ( administered double-blind ) and repeated the math and neuropsychological tasks ( posttest ) .


Baseline and posttest videorecordings of children performing the math task were coded to assess time on-task .


Children taking MPH completed 23 more math problems at posttest compared to baseline , whereas the placebo group completed 24 fewer problems on posttest versus baseline , but the effects on math accuracy ( percent correct ) did not differ .


Path analyses revealed that only change in time on-task was a significant mediator of MPH 's improvements in math productivity .


MPH-derived math productivity improvements may be explained in part by increased time spent on-task , rather than improvements in neurocognitive parameters , such as inhibitory control , selective attention , or reaction time variability .


We have developed nanoparticle - cyclodextrin dexamethasone ( DexNP ) and dorzolamide ( DorzNP ) eye drops that provide sustained high drug concentrations on the eye surface .


To test these characteristics , we measured dexamethasone and dorzolamide levels in tear fluid in humans following eye drop administration .


Concentration of dexamethasone was measured by mass spectrometry .


One drop of DexNP was instilled into one eye .


Tear fluid was sampled with microcapillary pipettes at seven time-points after drop instillation .


Control eyes received Maxidex ( ) ( dexamethasone ) .


The same procedure was performed for dorzolamide with DorzNP and Trusopt ( ) .


Six subjects were included in each group .


The peak concentration ( g/mlstandard deviation ) of dexamethasone for DexNP eye drops ( 636.6399.1 ) was up to 19-fold higher than with Maxidex ( ) ( 39.318.9 ) ( p < 0.001 ) .


At 4hr , DexNP was still 10 times higher than Maxidex ( ) .


In addition , DexNP resulted in about 30-fold higher concentration of dissolved dexamethasone in the tear fluid of extended time period allowing more drug to partition into the eye tissue .


The overall concentration of dorzolamide was about 50 % higher for DorzNP ( 59.576.9 ) than Trusopt ( ) ( 40.076.7 ) ( p < 0.05 ) .


The results indicate high and extended concentration of dissolved dexamethasone with DexNP , which can explain the greater and longer lasting effect of dexamethasone in the cyclodextrin nanoparticle drug delivery platform .


Dexamethasone seems to fit the cyclodextrin nanoparticle suspension drug delivery platform with longer duration and higher concentrations in tear fluid than available commercial drops , while dorzolamide is less suitable .


Subtherapeutic plasma isoniazid ( INH ) concentrations and the development of bacterial resistance may be attributed to poor quality and reduced bioavailability of fixed-dose combination ( FDC ) formulations .


The bioavailability of INH from a generic and that of a branded FDC formulation had not been compared in the Mexican population .


To evaluate the bioequivalence of a generic three-drug FDC formulation ( 3FDC ) in comparison with a 3FDC reference with doses of 300 mg INH in 20 healthy Mexican adults , and to generate data regarding the oral relative bioavailability of the drug in this population .


A single-dose , randomised-sequence , open-label , two-period crossover study .


Both formulations were well tolerated .


The pharmacokinetic parameters of INH showed wide inter-individual variability .


The average relative bioavailability calculated for maximum serum concentration area under the concentration-time curve ( AUC ) , AUC ( 0-24h ) and AUC ( 0 - ) of the test 3FDC formulation vs. the 3FDC reference were respectively 64.84 % ( 90 % CI 56.01-75 .06 ) , 59.05 % ( 90 % CI 50.27-69 .36 ) and 57.26 % ( 90 % CI 46.93-69 .84 ) .


The 3FDC test and reference formulations were not bioequivalent because the 90 % CI for the geometric mean ratios did not meet the regulatory requirements for bioequivalence ( range 80-125 % ) based on the rate and extent of absorption .


To compare bone mineral density ( BMD ) changes over 96 weeks in adults virologically failing standard first-line therapy , randomized to raltegravir plus lopinavir/ritonavir ( RAL + LPV/r ) or conventional 2-3 nucleoside/nucleotide reverse transcriptase inhibitors [ N ( t ) RTIs ] + LPV/r second-line therapy .


Participants underwent dual-energy x-ray absorptiometry at baseline and weeks 48 and 96 to measure total hip and lumbar spine BMD .


Analyses were adjusted for gender , body mass index , and smoking .


Linear regression was used to compare between-group differences , logistic regression for low BMD ( hip or spine Z-score -2 ) incidence , and multivariate linear regression to determine predictors of BMD change .


This work represents the extension and final results of the previously published initial 48 weeks of the study .


The population included 210 adults from 5 middle-income countries : 52 % females , 52 % Asians , 43 % Africans , mean age , 39 years ( SD , 8 years ) .


In the 2-3 N ( t ) RTI group ( vs. RAL ) , BMD reduction was greater at the spine ( mean change , -4.9 % vs. -3.5 % ; adjusted difference , -1.9 % ; 95 % confidence interval : -3.3 to -0.5 % , P = 0.009 ) and hip ( -4.1 % vs. -2.2 % ; -1.9 % ; -3.4 to -0.4 ; P = 0.012 ) .


BMD decrease was greatest at 48 weeks with stabilization to week 96 .


Overall , low BMD occurred in 15 participants ( 7.9 % ) , with no between-group differences .


Independent predictors for bone loss included lower body mass index ( regression coefficient : hip , -0.18 % and spine , -0.26 % per 1 kg/m ) , longer tenofovir exposure ( hip , -0.74 % and spine , -1.0 % per year ) , greater change in CD4 to week 12 ( hip , -5.11 % per 10-fold higher ) , and higher baseline HIV-RNA ( spine , -0.7 % per 10-fold higher ) .


Over 96 weeks , there was greater BMD decrease with 2-3 N ( t ) RTI + LPV/r compared with RAL + LPV/r ; the relative decrease at the spine was greater than the hip .


BMD decreases with second-line antiretroviral therapy largely occurred in the first 48 weeks with stabilization , but no recovery thereafter .


Because early life growth has long-lasting metabolic and behavioral consequences , intervention during this period of developmental plasticity may alter long-term obesity risk .


While modifiable factors during infancy have been identified , until recently , preventive interventions had not been tested .


The Intervention Nurses Starting Infants Growing on Healthy Trajectories ( INSIGHT ) .


Study is a longitudinal , randomized , controlled trial evaluating a responsive parenting intervention designed for the primary prevention of obesity .


This `` parenting '' intervention is being compared with a home safety control among first-born infants and their parents .


INSIGHT 's central hypothesis is that responsive parenting and specifically responsive feeding promotes self-regulation and shared parent-child responsibility for feeding , reducing subsequent risk for overeating and overweight .


316 first-time mothers and their full-term newborns were enrolled from one maternity ward .


Two weeks following delivery , dyads were randomly assigned to the `` parenting '' or `` safety '' groups .


Subsequently , research nurses conduct study visits for both groups consisting of home visits at infant age 3-4 , 16 , 28 , and 40 weeks , followed by annual clinic-based visits at 1 , 2 , and 3 years .


Both groups receive intervention components framed around four behavior states : Sleeping , Fussy , Alert and Calm , and Drowsy .


The main study outcome is BMI z-score at age 3 years ; additional outcomes include those related to patterns of infant weight gain , infant sleep hygiene and duration , maternal responsiveness and soothing strategies for infant/toddler distress and fussiness , maternal feeding style and infant dietary content and physical activity .


Maternal outcomes related to weight status , diet , mental health , and parenting sense of competence are being collected .


Infant temperament will be explored as a moderator of parenting effects , and blood is collected to obtain genetic predictors of weight status .


Finally , second-born siblings of INSIGHT participants will be enrolled in an observation-only study to explore parenting differences between siblings , their effect on weight outcomes , and carryover effects of INSIGHT interventions to subsequent siblings .


With increasing evidence suggesting the importance of early life experiences on long-term health trajectories , the INSIGHT trial has the ability to inform future obesity prevention efforts in clinical settings .


NCT01167270 .


Registered 21 July 2010 .


We evaluated the effectiveness of offering adjunctive financial incentives for abstinence ( contingency management [ CM ] ) within a safety net hospital smoking cessation program .


We randomized participants ( n = 146 ) from a Dallas County , Texas , Tobacco Cessation Clinic from 2011 to 2013 to usual care ( UC ; cessation program ; n = 71 ) or CM ( UC + 4 weeks of financial incentives ; n = 75 ) , and followed from 1 week before the quit date through 4 weeks after the quit date .


A subset ( n = 128 ) was asked to attend a visit 12 weeks after the scheduled quit date .


Participants were primarily Black ( 62.3 % ) or White ( 28.1 % ) and female ( 57.5 % ) .


Most participants were uninsured ( 52.1 % ) and had an annual household income of less than $ 12000 ( 55.5 % ) .


Abstinence rates were significantly higher for those assigned to CM than UC at all visits following the quit date ( all Ps < .05 ) .


Point prevalence abstinence rates in the CM and UC groups were 49.3 % versus 25.4 % at 4 weeks after the quit date and 32.8 % versus 14.1 % at 12 weeks after the quit date .


CM participants earned an average of $ 63.40 ( $ 150 possible ) for abstinence during the first 4 weeks after the scheduled quit date .


Offering small financial incentives for abstinence might be an effective means to improve abstinence rates among socioeconomically disadvantaged individuals participating in smoking cessation treatment .


To evaluate the change of epithelial and flap thickness after femtosecond laser-assisted in situ keratomileusis ( LASIK ) using spectral-domain optical coherence tomography ( SD OCT ) in correlation with the spherical equivalent refraction treated and clinical outcomes .


Prospective , randomized , contralateral-eye study .


Forty myopic eyes underwent LASIK using an excimer laser with refraction ranging from -1.00 to -7.25 diopters ( mean -3.251.9 ) .


Flap creation was randomized between eyes , using the IntraLASE FS60 laser ( IL ) in 1 eye and WaveLight FS200 laser ( FS ) in the contralateral eye .


SD OCT was used to evaluate the epithelial and flap thickness profiles and corneal power preoperatively and at 1 week and 1 , 3 , and 9 months postoperatively .


Manifest and wavefront refractions were performed at each postoperative visit .


Statistically significant epithelial thickening was observed in both IL and FS groups as early as 1 month postoperatively ( P = .033 and P = .042 ) , but this stabilized between 3 ( P = .042 and P = .035 ) and 9 months ( P = .043 and P = .041 ) .


Femtosecond-LASIK flaps were thicker in the IL group in comparison to the FS group at 3 and 9 months postoperatively ( P = .003 and P = .005 , respectively ) .


There was a statistically significant correlation between the magnitude of preoperative myopic refraction and the central epithelial thickness at 1 , 3 , and 9 months ( Pearson correlation coefficients 0.485 , 0.587 and 0.576 ) ( P = .0021 , P = .0010 , and P = .0011 ) , respectively .


SD OCT corneal power maps showed steepening at 3 and 9 months along with mild myopic shift .


Progressive epithelial and flap thickening with increased corneal power were observed after femtosecond laser-assisted in situ keratomileusis for myopia with consequent stabilization between 3 to 9 months postoperatively .


The magnitude of epithelial and flap thickness remodeling correlated to the preoperative myopic refractive error .


The objective of this research project is to understand and to improve workers ' recovery from work stress .


Although recovery during lunch breaks is the most common within-workday break , it has received only minor research attention .


Therefore , we will study whether lunch breaks including a relaxation session or exposure to nature have more favorable outcomes than usually spent lunch breaks concerning : a ) recovery processes , b ) health , c ) well-being , d ) job performance and e ) creativity .


We approach recovery by combining the theoretical frameworks of work and environmental psychology .


We conduct an intervention study in a sample of 268 knowledge-workers who engage in different lunch break activities for 15-minutes per day , two weeks in a row .


We randomly assign participants to three experimental conditions : 1 ) exposure to nature , 2 ) relaxation and 3 ) control group ( lunch break spent as usual ) .


Online questionnaires before and after the intervention assess long term changes regarding recovery processes and the major outcome variables .


Before , during and after the intervention , SMS and paper-pencil questionnaires measure the same constructs four times a day with fewer items .


We also measure blood pressure and collect saliva samples to map cortisol excretion across the intervention period .


A timed experimental task ( i.e. , the Alternative Uses Task ) is used to examine differences in creativity between the three groups after the intervention period .


By combining the knowledge of work and environmental psychology about recovery and restorative experiences , by merging three recovery perspectives ( settings , processes , and outcomes ) and by using data triangulation , we produce valid results that broaden our view on mechanisms underlying recovery and enhance our understanding about their links to psychological , behavioural and physiological outcomes , resulting in a more comprehensive picture of work stress recovery in general .


ClinicalTrials.gov Protocol Registration System NCT02124837 .


Registered 24 April 2014 .


Rheumatoid arthritis ( RA ) is one of the most prevalent autoimmune diseases worldwide .


Some researchers have suggested that the serum vitamin D ( VitD ) level may relate to disease activity .


The current study was designed to identify the correlation between vitaminD prescription and prevention of relapses in rheumatoid arthritis .


A double blinded , randomized controlled trial study was performed using 80RA patients .


RA was controlled and patients were in remission during the past 2months .


Serum level of VitD in the studied patients was below 30ng/dl .


Patients were randomly allocated to receive VitD or placebo .


In the 6-month follow-up period , the Disease Activity Score 28 ( DAS28 ) was used in case of relapses as an index of RA activity to compare the two groups .


The flare rate was not different between two groups ( p > 0.05 ) .


The odds ratio of the rate of decline in patients of the trial group compared with the control group was 1.17 ( not significant ; p > 0.05 ) .


The mean DAS28 between the two patient groups was not significant ( p > 0.05 ) .


A low VitD level was not identified to be a risk factor for RA severity or flare ups ; however , although not statistically significant , VitD treatment might be clinically effective .


Further studies are needed with more emphasis on the issue of cost effectiveness and clinical importance to provide more information .


The CX3CR1 gene is implicated as a candidate gene for age-related macular degeneration ( AMD ) through several lines of evidence .


There is uncertainty , however , as to whether common genetic variants in CX3CR1 alter risk of AMD , since prior studies have been inconsistent and mostly limited to evaluation of 2 nonsynonymous variants , T280M ( rs3732378 ) and V249I ( rs3732379 ) .


To determine if common variants in CX3CR1 predict future risk of AMD .


Prospective nested case-control study within 5 large study populations with long-term follow-up .


We measured genotypes for T280M , V249I , and 13 other common single-nucleotide polymorphisms ( SNPs ) of the CX3CR1 gene among people who developed AMD ( n = 1110 , including 369 with neovascular AMD ) and 2532 age - and sex-matched controls .


We determined the incidence rate ratios ( RR ) and 95 % CIs for incidence of AMD for each variant and examined interactions with other AMD-associated variants and modifiable risk factors .


In additive genetic models , we identified nonsignificant associations with AMD for T280M ( RR , 0.87 ; P = .07 ) and 3 other SNPs , rs2853707 ( RR , 0.88 ; P = .07 ) , rs12636547 ( RR , 0.85 ; P = .10 ) , and rs1877563 ( RR , 0.84 ; P = .06 ) , 1 of which , rs2853707 , is positioned in the CX3CR1 promoter region and was associated with neovascular AMD ( RR , 0.75 ; P = .03 ) .


We observed that a recessive model was a better fit to the data for some SNPs , with associations between rs11715522 and AMD ( RR , 1.27 ; P = .03 ) and between rs2669845 ( RR , 3.10 ; P = .04 ) , rs2853707 ( RR , 0.48 ; P = .050 ) , and rs9868689 ( RR , 0.31 ; P = .02 ) and neovascular AMD .


Moreover , in exploratory analyses , we identified a number of possible interactions including between V249I and rs2669845 and dietary intake of -3 fatty acids ( P = .004 and P = .009 , respectively ) for AMD ; between rs2669845 and obesity ( P = .03 ) for neovascular AMD ; between T280M and complement component 3 ( C3 ) R102G for AMD ( P = .03 ) ; between rs2669845 and Y402H in complement factor H for AMD ( P = .04 ) ; and between rs2669845 , rs2853707 , and V249I and C3 R102G for neovascular AMD ( P = .008 ; .04 ; and .002 , respectively ) .


This study failed to identify significant associations between common CX3CR1 variants and AMD after considering the number of SNPs analyzed and multiple comparisons .


However , we observed evidence consistent with recessive modes of association and that an effect of CX3CR1 variants may depend on other factors including dietary intake of -3 fatty acids , obesity , and genotypes at CFH Y402H and C3 R102G .


If replicated in other populations , these findings would support a role for CX3CR1 in AMD but also suggest that its role may involve mechanisms that are independent of the T280M/V249I variations .


Successful application of noninvasive ventilation ( NIV ) for acute respiratory failure ( ARF ) requires patient cooperation and comfort .


The efficacy and safety of early IV dexmedetomidine when added to protocolized , as-needed IV midazolam and fentanyl remain unclear .


Adults with ARF and within 8 h of starting NIV were randomized to receive IV dexmedetomidine ( 0.2 g/kg/h titrated every 30 min to 0.7 g/kg/h to maintain a Sedation-Agitation Scale [ SAS ] score of 3 to 4 ) or placebo in a double-blind fashion up to 72 h , until NIV was stopped for 2 h , or until intubation .


Patients with agitation ( SAS 5 ) or pain ( visual analog scale 5 of 10 cm ) 15 min after each dexmedetomidine and placebo increase could receive IV midazolam 0.5 to 1.0 mg or IV fentanyl 25 to 50 g , respectively , at a minimum interval of every 3 h.


The dexmedetomidine ( n = 16 ) and placebo ( n = 17 ) groups were similar at baseline .


Use of early dexmedetomidine did not improve NIV tolerance ( score , 1 of 4 ; OR , 1.44 ; 95 % CI , 0.44-4 .70 ; P = .54 ) nor , vs. placebo , led to a greater median ( interquartile range ) percent time either tolerating NIV ( 99 % [ 61 % -100 % ] vs. 67 % [ 40 % -100 % ] , P = .56 ) or remaining at the desired sedation level ( SAS score = 3 or 4 , 100 % [ 86 % -100 % ] vs. 100 % [ 100 % -100 % ] , P = .28 ] , or fewer intubations ( P = .79 ) .


Although use of dexmedetomidine was associated with a greater duration of NIV vs placebo ( 37 [ 16-72 ] vs. 12 [ 4-22 ] h , P = .03 ) , the total ventilation duration ( NIV + invasive ) was similar ( 3.3 [ 2-4 ] days vs. 3.8 [ 2-5 ] days , P = .52 ) .


More patients receiving dexmedetomidine had one or more episodes of deep sedation vs placebo ( SAS 2 , 25 % vs. 0 % , P = .04 ) .


Use of midazolam ( P = .40 ) and episodes of either severe bradycardia ( heart rate 50 beats/min , P = .18 ) or hypotension ( systolic BP 90 mm Hg , P = .64 ) were similar .


Initiating dexmedetomidine soon after NIV initiation in patients with ARF neither improves NIV tolerance nor helps to maintain sedation at a desired goal .


Randomized , multicenter trials targeting patients with initial intolerance are needed to further elucidate the role for dexmedetomidine in this population .


It is recommended to wait at least 1 min between blood pressure ( BP ) readings .


However , there is insufficient evidence on the utility of this recommendation using a validated automatic device .


The aim was to assess differences in BP according to the waiting time between BP readings .


The study was designed as a cross-sectional descriptive study in hypertensive patients attended in primary care.Patients were seated for 5 min before six baseline BP readings : three BP measurements with no waiting time [ immediate readings ( IR ) ] between them and three BP measurements with 1 min of waiting time [ waiting readings ( WR ) ] between each reading , in random order .


The intraclass correlation coefficient was calculated between IR and WR mean BP measurements , with 95 % confidence intervals ( CIs ) .


We included 150 hypertensive patients , 49.3 % women , 65.6 ( 12.8 ) years of age .


The mean systolic blood pressure ( SBP ) values for IR and WR measurements were 137.2 ( 95 % CI 134.2-140 .2 ) and 137.8 ( 95 % CI 134.8-140 .8 ) mmHg , respectively .


The mean diastolic blood pressure ( DBP ) values for IR and WR measurements were 79.4 ( 95 % CI 77.5-81 .4 ) and 79.7 ( 95 % CI 77.7-81 .8 ) mmHg , respectively .


Intraclass correlation coefficient between IR and WR was 0.959 ( 95 % CI 0.943-0 .970 ) and 0.926 ( 95 % CI 0.898-0 .946 ) for SBP and DBP , respectively .


The mean difference between both methods for SBP and DBP was -0.60 ( 95 % CI -1.79 to 0.5 ) and -0.27 ( 95 % CI -1.33 to 0.77 ) mmHg , respectively .


We found a good agreement between waiting or not waiting 1 min between office BP readings .


This demonstrates that both methods of BP measurement appear to be interchangeable .


The study aim was to compare the incidence of esophageal injuries between different temperature probes in the monitoring of esophageal temperature during atrial fibrillation ( AF ) ablation .


One hundred patients with drug-resistant AF were prospectively and randomly assigned into two groups according to the esophageal temperature probe used : the multi-thermocouple probe group ( n = 50 ) and the deflectable temperature probe group ( n = 50 ) .


Extensive pulmonary vein ( PV ) isolation was performed with a 3.5-mm open irrigated tip ablation catheter by using a radiofrequency ( RF ) power of 25-30 W.


In both groups , the esophageal temperature thermocouple was placed on the area of the esophagus adjacent to the ablation site .


When the esophageal temperature reached 42 C , the RF energy delivery was stopped .


Esophageal endoscopy was performed 1 day after the catheter ablation .


No differences existed between the two groups in terms of clinical background and various parameters related to the catheter ablation , including RF delivery time and number of RF deliveries at an esophageal temperature of > 42 C. Esophageal lesions , such as esophagitis and esophageal ulcers , occurred in 10/50 ( 20 % ) and 15/50 ( 30 % ) patients in the multi-thermocouple and deflectable temperature probe groups , respectively ( P = 0.25 ) .


Most lesions were mild to moderate injuries , and all were cured using conservative treatment .


The incidence of esophageal injury was almost equal between the multi-thermocouple temperature probe and the deflectable temperature probe during esophageal temperature monitoring .


Most of the esophageal lesions that developed during esophageal temperature monitoring were mild to moderate and reversible .


Low-income Latinas ( Hispanics ) face risk for cardiovascular disease due to high rates of overweight/obesity , sedentary lifestyle , and other factors .


Limited access to health care and language barriers may prevent delivery of health promotion messages .


Targeted approaches , including the integration of community health workers , may be required to promote healthy lifestyle and prevent chronic disease in underserved ethnic minority groups .


The term commonly used to refer to female community health workers in Latino communities is `` promotora ( s ) . ''


This study evaluates the outcomes and feasibility of a promotora-led lifestyle behavior intervention for overweight , immigrant Latinas .


A community prevention model was employed in planning and implementing this study .


A randomized controlled trial design was used .


A Community Advisory Board provided expertise in evaluating feasibility of study implementation in the community and other important guidance .


The sample was comprised of 223 women aged 35-64 years , predominantly with low income and 8th grade education .


The culturally tailored Lifestyle Behavior Intervention included group education ( 8 classes based upon Su Corazon , Su Vida ) , followed by 4 months of individual teaching and coaching ( home visits and telephone calls ) .


The control group received a comparable length educational program and follow-up contacts .


Evaluations were conducted at baseline and at 6 and 9 months using a dietary habits questionnaire , accelerometer readings of physical activity , and clinical measures ( body mass index , weight , waist circumference , blood pressure , lipids , blood glucose ) .


Data were collected between January 2010 and August 2012 .


Women in the intervention group improved significantly in dietary habits , waist circumference , and physical activity in comparison to those in the control group .


A treatment dosage effect was observed for weight and waist circumference .


Knowledge about heart disease increased .


High attendance at classes and participation in the individual teaching and counseling sessions and high retention rates support the feasibility and acceptability of the promotora-led lifestyle behavior intervention .


Our findings demonstrate that lifestyle behaviors and other risk factors of overweight Latina women may be improved through a promotora-led lifestyle behavior intervention .


Feasibility of implementing this intervention in community settings and engaging promotoras as facilitators is supported .


Somatic mutations in PIK3CA ( phosphatidylinositol-4 ,5 - bisphosphonate 3-kinase [ PI3K ] , catalytic subunit alpha gene ) activate the PI3K-AKT signaling pathway and contribute to pathogenesis of various malignancies , including colorectal cancer .


We examined associations of PIK3CA oncogene mutation with relapse , survival , and treatment efficacy in 627 stage III colon carcinoma case subjects within a randomized adjuvant chemotherapy trial ( 5-fluorouracil and leucovorin [ FU/LV ] vs irinotecan [ CPT11 ] , fluorouracil and leucovorin [ IFL ] ; Cancer and Leukemia Group B 89803 [ Alliance ] ) .


We detected PIK3CA mutation in exons 9 and 20 by polymerase chain reaction and pyrosequencing .


Cox proportional hazards model was used to assess prognostic and predictive role of PIK3CA mutation , adjusting for clinical features and status of routine standard molecular pathology features , including KRAS and BRAF mutations and microsatellite instability ( mismatch repair deficiency ) .


All statistical tests were two-sided .


Compared with PIK3CA wild-type cases , overall status of PIK3CA mutation positivity or the presence of PIK3CA mutation in either exon 9 or 20 alone was not statistically significantly associated with recurrence-free , disease-free , or overall survival ( log-rank P > .70 ; P > .40 in multivariable regression models ) .


There was no statistically significant interaction between PIK3CA and KRAS ( or BRAF ) mutation status in survival analysis ( P ( interaction ) > .18 ) .


PIK3CA mutation status did not appear to predict better or worse response to IFL therapy compared with FU/LV therapy ( P ( interaction ) > .16 ) .


Overall tumor PIK3CA mutation status is not associated with stage III colon cancer prognosis .


PIK3CA mutation does not appear to serve as a predictive tumor molecular biomarker for response to irinotecan-based adjuvant chemotherapy .


Darunavir requires pharmacokinetic enhancement to increase its bioavailability .


Cobicistat is potentially an alternative pharmacokinetic booster to ritonavir .


Bioequivalence of a darunavir/cobicistat fixed-dose combination ( FDC ) versus darunavir and cobicistat co-administered as single agents and the effect of a high-fat meal on the pharmacokinetics of the FDC were evaluated .


In this Phase I , open-label , randomized , three-panel , crossover study ( NCT01619527 ) , healthy volunteers received a single dose of darunavir ( 800 mg ) with cobicistat ( 150 mg ) as either an FDC or as single agents co-administered under fasted ( panel 1 , n = 74 ) or fed ( breakfast , panel 2 , n = 40 ) conditions , or as the FDC under fasted versus fed ( high-fat breakfast ) conditions ( panel 3 , n = 19 ) , with a 7 day washout period between treatments .


Pharmacokinetic profiles , safety and tolerability were assessed .


90 % confidence intervals of the least square mean ratios for darunavir and cobicistat maximum plasma concentration and area under the plasma concentration-time curve ( AUC ) were all within 80.00 % and 125.00 % in panels 1 and 2 .


Administration of the FDC with a high-fat breakfast significantly increased darunavir maximum plasma concentration 2.27-fold and AUC 1.63-1 .70 - fold , whereas cobicistat pharmacokinetics were unaffected .


No volunteers discontinued due to adverse events ( AEs ) .


All AEs were grade 1 or 2 .


Overall , 27 ( 20 % ) and 26 ( 20 % ) volunteers had 1 AE at least possibly related to darunavir and cobicistat , respectively .


Bioequivalence of the darunavir/cobicistat 800/150-mg FDC was demonstrated versus darunavir and cobicistat co-administered as single agents under fasted or fed conditions .


Food increased darunavir exposure , therefore , darunavir/cobicistat should be administered with food .


This study investigated the prevalence of driven exercise ( DE ) and its role in treatment outcome for adolescents with bulimia nervosa ( BN ) and anorexia nervosa ( AN ) .


Participants were 201 adolescents with an eating disorder ( ED ) ( 80 with BN and 121 with AN ) presenting for outpatient treatment at two specialist clinics .


All adolescents participated in one of two randomized controlled trials .


Descriptive statistics were conducted to evaluate the presence and frequency of baseline DE .


Exploratory hierarchical regressions were used to evaluate the effect of baseline DE on treatment outcomes .


About 66.3 % of adolescents with BN and 23.1 % of adolescents with AN presented with baseline DE .


The presence of baseline DE predicted significantly worse outcomes for adolescents with AN in terms of ED symptom severity ( ps < .004 ) ; however , baseline DE did not significantly predict any of the evaluated outcomes for adolescents with BN ( ps < .05 ) .


The results of this secondary exploratory data suggest that DE is prevalent for adolescents with BN and AN .


However , DE may be related to different constructs for adolescents with AN than those with BN , suggesting differences in treatment needs .


In the SAFE-PCI for Women trial , patient preference for radial access for future procedures was greater than for femoral access .


We sought to assess whether radial or femoral access impacts formal measures of quality-of-life ( QOL ) among women undergoing cardiac catheterization .


We assessed QOL using European quality of life-5 dimensions ( EQ-5D ) and EQ visual analog scale ( EQ-VAS ) scores among 304 women randomized to radial or femoral arteriotomy in the SAFE-PCI for Women trial at sites with QOL substudy approval .


Patient surveys were administered at baseline , hospital discharge , and 30 days ( for percutaneous coronary intervention patients ) .


Women randomized to both treatments had similar EQ-5D index and EQ-VAS scores at baseline , hospital discharge , and 30-day follow-up .


After adjustment for baseline scores , there was no effect of assigned treatment on EQ-5D ( discharge 0.004 ; 95 % CI -0.03 to 0.04 ; 30 days -0.03 ; 95 % CI -0.09 to 0.02 ) or EQ-VAS ( discharge -1.31 ; 95 % CI -4.74 to 2.12 ; 30 days -2.10 ; 95 % CI -8.92 to 4.71 ) scores .


At discharge , 60.5 % versus 63.5 % ( P = .60 ) of patients in radial and femoral groups were free from access site pain ; at 30 days , rates were 85.7 % versus 77.6 % ( P = .30 ) , respectively .


Patient preference for the same access strategy for repeat procedures was greater in the radial versus femoral group ( 77.2 % vs 26.8 % ; P < .0001 ) .


Using established QOL instruments , we did not measure any difference in QOL or functional status according to access site strategy in women undergoing cardiac catheterization , yet patient preference for the radial approach was significantly greater .


Other factors influencing patient choice for radial access should be investigated .


To assess and compare the effects of four simultaneous-image multifocal contact lenses ( SIMCLs ) , and those with distant-vision-only contact lenses on visual performance in early presbyopes , under dim conditions , including the effects of induced glare .


In this double-masked crossover study design , 28 presbyopic subjects aged 40 to 46 years were included .


All participants were fitted with the four different SIMCLs ( Air Optix Aqua Multifocal [ AOAM ; Alcon ] , PureVision Multifocal [ PM ; Bausch & Lomb ] , Acuvue Oasys for Presbyopia [ AOP ; Johnson & Johnson Vision ] , and Biofinity Multifocal [ BM ; CooperVision ] ) and with monofocal contact lenses ( Air Optix Aqua , Alcon ) .


After 1 month of daily contact lens wearing , each subject 's binocular distance visual acuity ( BDVA ) and binocular distance contrast sensitivity ( BDCS ) were measured using the Functional Visual Analyzer ( Stereo Optical Co. , Inc. ) under mesopic conditions ( 3 candela [ cd ] / m ) both with no glare and under the 2 levels of induced glare : 1.0 lux ( glare 1 ) and 28 lux ( glare 2 ) .


Among the SIMCLs , in terms of BDVA , AOAM and PM outperformed BM and AOP .


All contact lenses performed better at level without glare , followed by Glare 1 , and with the worst results obtained under glare 2 .


Binocular distance contrast sensitivity revealed statistically significant differences for 12 cycles per degree ( cpd ) .


Among the SIMCLs , post hoc multiple comparison testing revealed that AOAM and PM provided the best BDCS at the three luminance levels .


In both cases , BDVA and BDCS at 12 cpd , monofocal contact lenses outperformed all SIMCL ones at all lighting conditions .


Air Optix Aqua Multifocal and PM provided better visual performance than BM and AOP for distance vision with low addition and under dim conditions , but they all provide worse performance than monofocal contact lenses .


Previous research incorporating yoga ( YG ) into radiotherapy ( XRT ) for women with breast cancer finds improved quality of life ( QOL ) .


However , shortcomings in this research limit the findings .


Patients with stages 0 to III breast cancer were recruited before starting XRT and were randomly assigned to YG ( n = 53 ) or stretching ( ST ; n = 56 ) three times a week for 6 weeks during XRT or waitlist ( WL ; n = 54 ) control .


Self-report measures of QOL ( Medical Outcomes Study 36-item short-form survey ; primary outcomes ) , fatigue , depression , and sleep quality , and five saliva samples per day for 3 consecutive days were collected at baseline , end of treatment , and 1 , 3 , and 6 months later .


The YG group had significantly greater increases in physical component scale scores compared with the WL group at 1 and 3 months after XRT ( P = .01 and P = .01 ) .


At 1 , 3 , and 6 months , the YG group had greater increases in physical functioning compared with both ST and WL groups ( P < .05 ) , with ST and WL differences at only 3 months ( P < .02 ) .


The group differences were similar for general health reports .


By the end of XRT , the YG and ST groups also had a reduction in fatigue ( P < .05 ) .


There were no group differences for mental health and sleep quality .


Cortisol slope was steepest for the YG group compared with the ST and WL groups at the end ( P = .023 and P = .008 ) and 1 month after XRT ( P = .05 and P = .04 ) .


YG improved QOL and physiological changes associated with XRT beyond the benefits of simple ST exercises , and these benefits appear to have long-term durability .


To evaluate the effectiveness of combined use of propofol and ketamine for total intravenous anesthesia ( TIVA ) in adults and to determine their optimal doses .


100 adults with general anesthesia were randomly divided into five groups [ K0 , K0 .5 , K1 , K1 .5 and K2 , with 0 , 0.5 , 1 , 1.5 and 2 mg / ( kg x h ) ketamine , respectively ] .


The dose of propofol administered during surgery and hemodynamics , respiratory recovery time , awakening time , steward score of recovery and adverse reactions of the patients were recorded .


Ten patients from each group were randomly chosen to have plasma concentrations of propofol and ketamine examined .


The dose of propofol and total price of the two drugs decreased with the increase of dosage of ketamine ( P < 0.05 ) .


Better outcomes in recovery indexes and adverse reactions were observed in Group K1 compared with those in Group K1 .5 and K2 ( P < 0.05 ) .


Plasma concentrations of ketamine in Group K1 , K1 .5 and K2 were higher than those in Group K0 .5 ( P < 0.05 ) .


Regression analyses showed a positive correlation between ` dose of ketamine and operation time ' and ` respiratory recovery time and awakening time ' and a negative correlation between ` dose of ketamine and operation time ' and ` steward score of recovery ' .


` Dose of ketamine ' was also associated with dreams , asleep after awakening , nystagmus and visual changes .


The dose ratio of ketamine and propofol was associated with dizzy and adverse reactions .


Continuous pump infusion of 1 mg / ( kg x h ) ketamine for TIVA in adults can reduce dosage of propofol and minimize adverse effects of ketamine .


Gemcitabine requires transporter proteins to cross cell membranes .


Low expression of human equilibrative nucleoside transporter-1 ( hENT1 ) may result in gemcitabine resistance in pancreatic ductal adenocarcinoma ( PDAC ) .


CO-101 , a lipid-drug conjugate of gemcitabine , was rationally designed to enter cells independently of hENT1 .


We conducted a randomized controlled trial to determine whether CO-101 improved survival versus gemcitabine in patients with metastatic PDAC ( mPDAC ) with low hENT1 .


The study also tested the hypothesis that gemcitabine is more active in patients with mPDAC tumors with high versus low hENT1 expression .


Patients were randomly assigned to CO-101 or gemcitabine , after providing a metastasis sample for blinded hENT1 assessment .


An immunohistochemistry test measuring tumor hENT1 was developed .


To dichotomize the population , an hENT1 cutoff value was defined using primary PDAC samples from an adjuvant trial , and a high/low cutoff was applied .


The primary end point was overall survival ( OS ) in the low hENT1 subgroup .


Of 367 patients enrolled , hENT1 status was measured in 358 patients ( 97.5 % ) .


Two hundred thirty-two ( 64.8 % ) of 358 patients were hENT1 low .


There was no difference in OS between treatments in the low hENT1 subgroup or overall , with hazard ratios ( HRs ) of 0.994 ( 95 % CI , 0.746 to 1.326 ) and 1.072 ( 95 % CI , 0.856 to 1.344 ) , respectively .


The toxicity profiles in both arms were similar .


Within the gemcitabine arm , there was no difference in survival between the high and low hENT1 subgroups ( HR , 1.147 ; 95 % CI , 0.809 to 1.626 ) .


CO-101 is not superior to gemcitabine in patients with mPDAC and low tumor hENT1 .


Metastasis hENT1 expression did not predict gemcitabine outcome .


Afatinib is a potent , irreversible , ErbB family blocker in clinical development for the treatment of advanced non-small cell lung cancer , metastatic head and neck cancer , and other solid tumours .


As afatinib is a substrate for the P-glycoprotein ( P-gp ) pump transporter the three studies presented here investigated the pharmacokinetics of afatinib in the presence of a potent inhibitor ( ritonavir ) or inducer [ rifampicin ( rifampin ) ] of P-gp .


We conducted phase I , open-label , single-centre studies in healthy male volunteers who received a single once-daily oral dose of afatinib ( 20 or 40 mg ) together with either ritonavir or rifampicin ; two studies had a randomised , two - and three-way crossover design and the third was a non-randomised , two-period sequential study .


When afatinib 20 mg was administered 1 h after ritonavir , afatinib geometric mean ( gMean ) maximum plasma concentration ( C max ) and area under the plasma concentration-time curve from time zero to infinity ( AUC ) increased by 38.5 and 47.6 % , respectively .


Coadministration of ritonavir either simultaneously or 6 h later than afatinib 40 mg resulted in minimal increase in the afatinib gMean C max and AUC ( 4.1 and 18.6 % for simultaneous administration with AUC not completely within the bioequivalence limits ; 5.1 and 10.8 % for timed administration within the bioequivalence limits ) .


Administration of afatinib 40 mg in the presence of rifampicin led to reduction in C max and AUC by 21.6 and 33.8 % , respectively .


In all studies , P-gp modulation mainly affected the extent of absorption of afatinib ; there was no change in the terminal elimination half-life .


The overall safety profile of afatinib was acceptable .


Coadministration of potent P-gp modulators had no clinically relevant effect on afatinib exposure .


Effects of potent P-gp inhibitors were minimal at higher afatinib doses and can be readily managed by the timing of concomitant therapy .


As afatinib is not a relevant modulator or substrate of cytochrome P450 enzymes , the drug-drug interaction potential is considered to be low .


Entonox ( N2O2 ) which is an inhalational gas for relieving labor pain is commonly used intermittently ; however some women are interested in continuous breathing in face mask .


So we decided to compare the complications induced by two methods to find out whether it is safe to permit the mothers to use Entonox continuously or not .


This randomized clinical trial was performed in Mobini Hospital , Sabzevar , Iran .


50 parturients used Entonox intermittently and 50 cases used it continuously during labor .


Then obstetrical outcomes were analyzed in two groups by spss 17 software , t-test , and Chi ( 2 ) while P < 0.05 was considered significant .


This study showed the mean duration of second stage of labor had no significant difference ( P = 0.3 ) .


Perineal laceration was less in continuous group significantly ( P = 0.04 ) .


Assisted vaginal birth was not different significantly ( P = 0.4 ) .


Uterine atony had no significant difference in two groups ( P = 0.2 ) .


Maternal collaboration in pushing and satisfaction were higher in continuous group significantly ( P = 0.03 ) , ( P < 0.0001 ) .


Apgar score of neonates at first and fifth minute was acceptable and not different significantly in two groups ( P = 0.3 ) .


Our study demonstrated continuous method is also safe .


So , it seems reasonable to set mothers free to choose the desired method of Entonox usage .


Treatment nonadherence and relapse are common problems in patients with schizophrenia .


The long-acting 3-month formulation of paliperidone palmitate , owing to its extended elimination half-life , may offer a valuable therapeutic option for these patients .


To evaluate the efficacy and safety of the 3-month formulation of paliperidone palmitate vs placebo in delaying time to relapse of schizophrenia symptoms .


This randomized , multicenter trial conducted from April 26 , 2012 , through April 9 , 2014 , in 8 countries consisted of 4 phases : 3-week screening phase , flexible-dose 17-week open-label transition phase , 12-week open-label maintenance phase , and open-ended double-blind ( DB ) phase .


Of the 506 patients enrolled ( aged 18-70 years ; DSM-IV-TR diagnosis of schizophrenia ) , 305 were randomized to 3-month paliperidone palmitate ( n = 160 ) or placebo ( n = 145 ) in the DB phase .


Patients received once-monthly doses of the 1-month formulation of paliperidone palmitate ( 50 , 75 , 100 , or 150 mg eq ) during the transition phase , followed by a single dose of the 3-month formulation ( 3.5 times the stabilized dose of once-monthly paliperidone palmitate ) during the maintenance phase .


Stabilized patients were randomized to receive either a fixed dose of 3-month paliperidone palmitate ( 175 , 263 , 350 , or 525 mg eq ) or placebo once every 3 months during the DB phase .


Time from randomization to the first relapse event ( time to relapse ) in the DB phase .


In the interim analysis , time to first relapse was significantly different in favor of the paliperidone palmitate group vs the placebo group ( hazard ratio = 3.45 ; 95 % CI , 1.73-6 .88 ; P < .001 ) ; median time to relapse was 274 days for placebo but not estimable for 3-month paliperidone palmitate .


An independent data monitoring committee recommended early study termination due to efficacy .


In the DB phase , 183 of 305 patients ( 62 % with 3-month paliperidone palmitate ; 58 % with placebo ) had at least 1 treatment-emergent adverse event ; those noted more frequently in the group receiving paliperidone palmitate than in the placebo group were headache ( 9 % vs 4 % ) , weight increased ( 9 % vs 3 % ) , nasopharyngitis ( 6 % vs 1 % ) , and akathisia ( 4 % vs 1 % ) .


Compared with placebo , the 3-month formulation of paliperidone palmitate administered 4 times yearly significantly delayed time to relapse in patients with schizophrenia .


The 3-month formulation was generally tolerable and has a safety profile consistent with other marketed paliperidone formulations .


clinicaltrials.gov Identifier : NCT01529515 .


Functional endoscopic sinus surgery ( FESS ) has become the treatment of choice for patients with medically resistant chronic rhinosinusitis ( CRS ) and nasal polyps .


Despite the consolidated use of different treatments , the postoperative period is often very painful and uncomfortable , especially during the first month .


Although evidence on the effectiveness of sodium hyaluronate ( SH ) on postoperative care following FESS is available , data on the quality of life ( QoL ) from the patients ' perspective are still lacking .


This study aimed to evaluate for the first time the effectiveness of nasal douche with SH in reducing patients ' discomfort during the first month following FESS .


A double-blind randomized controlled study was carried out on 124 subjects undergoing FESS for CRS with nasal polyposis .


They were divided into 2 groups : group I was treated with nasal douche containing 9 mg of high molecular weight SH plus saline solution and group II was treated with saline solution alone .


To assess QoL in CRS patients , the Short Form-36 ( SF-36 ) test , the Sino-Nasal Outcome Test-22 ( SNOT-22 ) , and the visual analogue scale ( VAS ) questionnaires were administered .


At baseline , there were no statistically significant differences between the 2 groups .


However , after 30 days of long postoperative treatments , we found clinically significant improvements in QoL of subjects treated with SH , as evidenced by all QoL scales .


Our data indicate that SH significantly improves patients ' short-term QoL following FESS in terms of both general health and specific sinonasal status .


Kinetic oscillation stimulation ( KOS ) of nasal mucosa at low frequency seems to be a possibly effective and safe short-term treatment of non-allergic nasal stuffiness .


To assess the relief of rhinitis symptoms , especially stuffiness , by comparing active treatment , i.e. KOS at low frequency of the nasal mucosa , with placebo .


Patients were randomized to active or placebo treatment in this double-blinded parallel design study .


Treatment with an inflatable oscillating catheter was administered on day 0 , and symptom scores ( stuffiness , secretion , and itching ) were graded daily until day 14 .


An overall grading of symptoms from 1 week before treatment and during 14 days thereafter was made at day 14 .


Eighty-six patients ( 52 with non-allergic perennial rhinitis , NAR ; 34 with rhinitis medicamentosa , RM ) were randomized , and 71 were evaluated ( active treatment , n = 35 ; placebo , n = 36 ) .


Patients with either NAR or RM who received active treatment reported reduced symptom scores by some measures , e.g. median RQSS stuffiness measure fell from 2 to 1 on a scale from 0 to 3 during the week following treatment .


No significant effect was observed for patients treated with placebo .


Mild side effects were reported .


The aim of study was to confirm the protective effects of parenteral glutamine supplementation on liver injury in premature infants and determine how quickly effects became evident .


We performed a double-blind , randomized , controlled clinical study to assess the effect of parenteral nutrition ( PN ) supplemented with glutamine in premature infants .


Thirty infants from two children 's centers , were randomly assigned to either a control group ( Standard PN ; n = 15 ) or a glutamine-supplemented group ( GlnPN ; n = 15 ) .


The primary endpoint was hepatic function .


The secondary endpoints were total duration of PN , weight and head circumference gain , length of hospitalization , and days on a ventilator .


The serum level of alkaline phosphatase ( AKP ) after parenteral nutrition for 14 days was significantly higher ( p < 0.05 ) in the control group .


But in the glutamine-supplemented group , the serum concentration of aspartate aminotransferase ( AST ) and gamma glutamyltransferase ( GGT ) significantly decreased after PN for 7 days and 14 days ( p < 0.05 ) , and the level of alkaline phosphatase ( AKP ) showed no increase .


The levels of AKP and GGT were significantly different with time by group interaction .


Levels of AKP was higher in control group than glutamine-supplemented group , and GGT level was lower in glutamine-supplemented group compared with controls .


There were no significant differences between the groups in terms of total duration of PN , weight gain ( g/d ) , increase in head circumference ( cm/w ) , length of hospitalization , and duration of mechanical ventilation .


The longer the duration of parenteral nutrition , the more severe hepatic dysfunction became .


Parenteral glutamine supplementation suggested a hepatoprotective effect .


Midazolam and propofol used alone for long-term sedation are associated with adverse effects .


Sequential use may reduce the adverse effects , and lead to faster recovery , earlier extubation and lower costs .


This study evaluates the effects , safety , and cost of midazolam , propofol , and their sequential use for long-term sedation in critically ill mechanically ventilated patients .


A total of 135 patients who required mechanical ventilation for > 3 days were randomly assigned to receive midazolam ( group M ) , propofol ( group P ) , or sequential use of both ( group M-P ) .


In group M-P , midazolam was switched to propofol until the patients passed the spontaneous breathing trial ( SBT ) safety screen .


The primary endpoints included recovery time , extubation time and mechanical ventilation time .


The secondary endpoints were pharmaceutical cost , total cost of ICU stay , and recollection to mechanical ventilation-related events .


The incidence of agitation following cessation of sedation in group M-P was lower than group M ( 19.4 % versus 48.7 % , P = 0.01 ) .


The mean percentage of adequate sedation and duration of sedation were similar in the three groups .


The recovery time , extubation time and mechanical ventilation time of group M were 58.0 ( interquartile range ( IQR ) , 39.0 ) hours , 45.0 ( IQR , 24.5 ) hours , and 192.0 ( IQR , 124.0 ) hours , respectively ; these were significantly longer than the other groups , while they were similar between the other two groups .


In the treatment-received analysis , ICU duration was longer in group M than group M-P ( P = 0.016 ) .


Using an intention-to-treat analysis and a treatment-received analysis , respectively , the pharmaceutical cost of group M-P was lower than group P ( P < 0.01 ) and its ICU cost was lower than group M ( P < 0.01 ; P = 0.015 ) .


The proportion of group M-P with unbearable memory of the uncomfortable events was lower than in group M ( 11.7 % versus 25.0 % , P < 0.01 ) , while the proportion with no memory was similar ( P > 0.05 ) .


The incidence of hypotension in group M-P was lower than group ( P = 0.01 ) .


Sequential use of midazolam and propofol was a safe and effective sedation protocol , with higher clinical effectiveness and better cost-benefit ratio than midazolam or propofol used alone , for long-term sedation of critically ill mechanically ventilated patients .


Current Controlled Trials ISRCTN01173443 .


Registered 25 February 2014 .


We tested the efficacy and toxicity of cisplatin plus accelerated fractionation with a concomitant boost ( AFX-C ) versus standard fractionation ( SFX ) in locally advanced head and neck carcinoma ( LA-HNC ) .


Patients had stage III to IV carcinoma of the oral cavity , oropharynx , hypopharynx , or larynx .


Radiation therapy schedules were 70 Gy in 35 fractions over 7 weeks ( SFX ) or 72 Gy in 42 fractions over 6 weeks ( AFX-C ) .


Cisplatin doses were 100 mg/m ( 2 ) once every 3 weeks for two ( AFX-C ) or three ( SFX ) cycles .


Toxicities were scored by using National Cancer Institute Common Toxicity Criteria 2.0 and the Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer criteria .


Overall survival ( OS ) and progression-free survival ( PFS ) rates were estimated by using the Kaplan-Meier method and were compared by using the one-sided log-rank test .


Locoregional failure ( LRF ) and distant metastasis ( DM ) rates were estimated by using the cumulative incidence method and Gray 's test .


In all , 721 of 743 patients were analyzable ( 361 , SFX ; 360 , AFX-C ) .


At a median follow-up of 7.9 years ( range , 0.3 to 10.1 years ) for 355 surviving patients , no differences were observed in OS ( hazard ratio [ HR ] , 0.96 ; 95 % CI , 0.79 to 1.18 ; P = .37 ; 8-year survival , 48 % v 48 % ) , PFS ( HR , 1.02 ; 95 % CI , 0.84 to 1.24 ; P = .52 ; 8-year estimate , 42 % v 41 % ) , LRF ( HR , 1.08 ; 95 % CI , 0.84 to 1.38 ; P = .78 ; 8-year estimate , 37 % v 39 % ) , or DM ( HR , 0.83 ; 95 % CI , 0.56 to 1.24 ; P = .16 ; 8-year estimate , 15 % v 13 % ) .


For oropharyngeal cancer , p16-positive patients had better OS than p16-negative patients ( HR , 0.30 ; 95 % CI , 0.21 to 0.42 ; P < .001 ; 8-year survival , 70.9 % v 30.2 % ) .


There were no statistically significant differences in the grade 3 to 5 acute or late toxicities between the two arms and p-16 status .


When combined with cisplatin , AFX-C neither improved outcome nor increased late toxicity in patients with LA-HNC .


Long-term high survival rates in p16-positive patients with oropharyngeal cancer support the ongoing efforts to explore deintensification .


For stable angina , the benefits of percutaneous coronary intervention ( PCI ) are limited to symptom relief , but patients often believe that PCI prevents myocardial infarction ( MI ) .


Whether presenting accurate information about the benefits of PCI would dispel these beliefs remains unknown .


We hypothesized that explanatory information would be more effective for influencing volunteers ' beliefs .


To assess the effect of explicit and explanatory information on participants ' beliefs about PCI and their willingness to choose it .


We conducted a randomized trial in 2012 among adults older than 50 years living in the general community .


We recruited participants using the Internet .


Participants read 1 of 3 scenarios in which they experienced class I angina and were referred to a cardiologist .


The cardiologist provided no information about the effects of PCI on MI risk , a specific statement that PCI does not reduce MI risk , or an explanation of why PCI does not reduce MI risk .


Participants ' beliefs about the benefit of PCI and choice of PCI and medication .


A total of 1257 participants ( 90.0 % ) completed the survey ; 54.5 % chose PCI .


Compared with those receiving explicit and explanatory information , those receiving no information were most likely to believe that PCI prevents MI ( 71.0 % vs 38.7 % vs 30.6 % , respectively ; P < .001 ) , most likely to choose PCI ( 69.4 % vs 48.7 % vs 45.7 % , respectively ; P < .001 ) , and least likely to agree to medication therapy ( 83.1 % vs 87.4 % vs 92.3 % , respectively ; P < .001 ) .


Across the entire sample , the decision to have PCI was strongly correlated with the belief that PCI would prevent MI ( odds ratio , 5.82 [ 95 % CI , 4.13-8 .26 ] ) and that the participant would feel less worried ( odds ratio , 5.36 [ 95 % CI , 3.87-7 .45 ] ) , but was not associated with how much participants were limited by symptoms .


In the setting of mild , stable angina , most people assume PCI prevents MI and are likely to choose it .


Explicit information can partially overcome that bias and influence decision making .


Explanatory information was the most effective intervention in overcoming this bias .


Smoking cessation interventions for hospitalized smokers are effective in promoting smoking cessation , but only if the tobacco dependence treatment continues after the patient leaves the hospital .


Sustaining tobacco dependence treatment after hospital discharge is a challenge for health care systems .


Our previous single-site randomized controlled trial demonstrated the effectiveness of an intervention that facilitated the delivery of comprehensive tobacco cessation treatment , including both medication and counseling , after hospital discharge .


We subsequently streamlined the intervention model to increase its potential for dissemination .


This new model is being tested in a larger multi-site trial with broader eligibility criteria in order to enroll a more representative sample of hospitalized smokers .


This paper describes the trial design and contrasts it with the earlier study .


A 2-arm , 3-site randomized controlled trial is testing the hypothesis that a multi-component Sustained Care intervention is more effective than Standard Care in helping hospitalized cigarette smokers stop smoking after hospital discharge .


The trial enrolls adult daily cigarette smokers who are admitted to 1 of 3 participating hospitals in Massachusetts or Pennsylvania .


Participants receive the same smoking cessation intervention in the hospital .


They are randomly assigned to receive either Standard Care or Sustained Care after hospital discharge .


Participants in the Sustained Care arm receive a free 3-month supply of FDA-approved smoking cessation medication and 5 interactive voice response calls that provide tailored motivational messages , medication refills , and access to a live tobacco treatment counselor .


Participants in the Standard Care arm receive a smoking cessation medication recommendation and information about community resources .


Outcomes are assessed at 1 , 3 , and 6 months after discharge .


The primary outcome is biochemically-validated tobacco abstinence for the past 7 days at 6-month follow-up .


Other outcome measures include self-reported tobacco abstinence measures , use of medication and counseling after discharge , hospital readmissions , and program cost-effectiveness .


We adapted a proven intervention for hospitalized smokers to enhance its potential for dissemination and are testing it in a multi-site trial .


Study enrollment data suggests that the trial achieved the goal of recruiting a broader sample of hospitalized smokers .


Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers ( Helping HAND2 ) NCT01714323 .


Registered October 22 , 2012 .


The relationships between Q waves that appear during the acute phase of ST-elevation myocardial infarction ( STEMI ) , clinical characteristics , ST-segment resolution ( STRes ) , and clopidogrel therapy in patients treated with fibrinolysis are not well described .


We hypothesized that Q waves would be associated with less successful reperfusion and increased cardiovascular events .


In the CLARITY-TIMI 28 trial , 3491 STEMI patients treated with fibrinolysis were randomized to clopidogrel or placebo .


Electrocardiograms were evaluated for STRes post-fibrinolysis and the presence of pathologic Q waves during the index hospitalization in 3322 patients .


Q waves were identified in 2045 patients ( 61.6 % ) prior to discharge and were associated with increased odds of congestive heart failure ( CHF ) ( adjusted odds ratio [ ORadj ] : 2.10 , P = 0.002 ) or the composite of cardiovascular death/CHF at 30days ( ORadj : 2.08 , P 0.001 ) .


Q waves were associated with lower odds of Thrombolysis in Myocardial Infarction [ TIMI ] flow grade 2 to 3 ( ORadj : 0.78 , P = 0.028 ) , TIMI myocardial perfusion grade 3 ( ORadj : 0.83 , P = 0.029 ) , and complete STRes at 90minutes ( ORadj : 0.80 , P = 0.030 ) .


Patients with both a Q wave and incomplete STRes 90minutes after fibrinolysis were at higher risk for cardiovascular death or CHF ( 11.1 % ) than patients with no Q wave and at least partial STRes ( 1.9 % ) .


Overall , clopidogrel tended to be equally or more effective in patients without Q waves compared to those with Q waves .


Among STEMI patients treated with fibrinolysis , evaluating for Q waves prior to discharge is a simple method of assessing for less successful reperfusion and an increased risk of adverse 30-day cardiovascular outcomes .


The combination of Q waves and 90-minute STRes allows additional risk refinement .


Risk-stratified screening for prostate cancer ( PCa ) with prostate-specific antigen ( PSA ) testing incorporating genetic variants has received some attention but has been scarcely investigated .


We developed a model to stratify the Finnish population by different risk profiles related to genetic variants to optimize the screening policy .


Data from the Finnish randomized controlled trial on screening for PCa with PSA testing were used to estimate a six-state Markov model of disease progression .


Blood samples from Finnish men were used to assess the risk of PCa related to three genetic variants ( rs4242382 , rs138213197 , and rs200331695 ) .


A risk score-based approach combined with a series of computer simulation models was applied to optimize individual screening policies .


The 10-year risk of having progressive prostate cancer detected ranged from 43 % in the top 5 % risk group to approximately 11 % in the bottom half of the population .


Using the median group , with screening every four years beginning at 55 years-old , as the reference group , the recommended age beginning screening was approximately 47 years-old for the top 5 % risk group and 55 years-old for those in the lower 60 % risk group .


The recommended interscreening interval has been shortened for individuals in the high risk group .


The increased availability of genomic information allows the proposed multistate model to be more discriminating with respect to risk stratification and the suggested screening policy , particularly for the lowest risk groups - .


A multi-state genetic variant-based model was developed for further application to population risk stratification to optimize the interscreening interval and the age at which to begin screening for PSA .


A small sub-group of the population is likely to benefit from more intensive screening with early start and short interval , while half of the population is unlikely to benefit from such protocol ( compared with four-year interval after age 55 years ) .


There are a limited number of marketed intravenous antiepileptic drugs ( AEDs ) available to treat status epilepticus ( SE ) .


All were first developed for chronic therapy of epilepsy , not specifically for SE .


Epilepsy and canine SE ( CSE ) occur naturally in dogs , with prevalence , presentation , and percentage of refractory cases similar to human epilepsy .


The objective of this study was to determine if CSE treated with fosphenytoin ( FOS ) results in a similar responder rate as for people .


A randomized clinical trial was performed for dogs with CSE .


Dogs who presented during a seizure or who had additional seizures after enrolling received intravenous ( i.v. ) benzodiazepine ( BZD ) followed immediately by intravenous infusion of 15 mg/kg phenytoin equivalent ( PE ) of fosphenytoin ( FOS ) or saline placebo ( PBO ) .


If seizures continued , additional AEDs were administered per the standard of care for veterinary patients .


Total and unbound plasma phenytoin ( PHT ) concentrations were measured .


Consent was obtained for 50 dogs with CSE .


Thirty-one had additional motor seizures and were randomized to the study intervention ( 22 FOS and 9 PBO ) .


There was a statistically significant difference in the 12 h responder rate , with 63 % in the FOS group versus 22 % in the placebo group ( p = 0.043 ) having no further seizures .


The unbound PHT concentrations at 30 and 60 min were within the therapeutic concentrations for people ( 1-2 g/ml ) with the exception of one dog .


There was mild vomiting in 36 % of the FOS group ( 7/22 ) within 20 min of FOS administration and none of the placebo group ( 0/9 ) ( p = 0.064 ) .


This proof of concept study provides the first evidence that FOS is tolerated and effective in canine SE at PHT concentrations clinically relevant for human SE .


Furthermore , naturally occurring CSE can be utilized as a translational platform for future studies of novel SE compounds .


Fenofibrate reduced progression of diabetic retinopathy in two large randomized studies .


The effect of 135mg fenofibric acid on diabetic macular edema ( DME ) was evaluated in subjects with existing DME .


In this double-blind , randomized , placebo-controlled study , 110 subjects with DME not requiring immediate photocoagulation or intraocular treatment with adequate diabetes and blood pressure control received either fenofibric acid or placebo once daily for 1 year .


Total macula volume ( TMV ) and thickness were measured in the worse eye and all eligible eyes with time-domain optical coherence tomography at baseline and quarterly thereafter .


TMV decreased by -0.35 mm ( 3 ) ( within-group difference ) after fenofibric acid treatment and by -0.11 mm ( 3 ) after placebo .


The between-group comparison of the change was -0.25 mm ( 3 ) ( 95 % confidence interval , CI , -0.645 -0.155 ; p = 0.227 , worse eye analysis ) .


Weighted inner zone thickness and volume decreased by -18.7 m and -0.13 mm ( 3 ) , respectively , for within group difference after fenofibric acid and by -3.1 m and -0.02 mm ( 3 ) , respectively , after placebo .


Considering all eligible eyes , thicknesses at central zone , mean inner zone , and entire retina decreased by -21.3 m , -19.8 m , and -20.4 m , respectively , after fenofibric acid .


No between-group difference in changes of these measurements was observed .


Triglycerides decreased by 23 % after fenofibric acid ( vs 4 % after placebo , p = 0.001 ) and high-density lipoprotein cholesterol increased by 8 % ( vs 0.3 % , p = 0.014 ) .


No safety concern was identified .


Subjects treated with fenofibric acid had a modest improvement in TMV , although the study was probably underpowered to detect a benefit over placebo after 1 year .


The aim of this study was to determine whether transcranial direct current stimulation ( tDCS ) applied to the primary motor hand area modulates hand dexterity and selective attention after stroke .


This study was a double-blind , placebo-controlled , randomized crossover trial involving subjects with chronic stroke .


Ten stroke survivors with some pinch strength in the paretic hand received three different tDCS interventions assigned in random order in separate sessions-anodal tDCS targeting the primary motor area of the lesioned hemisphere ( M1lesioned ) , cathodal tDCS applied to the contralateral hemisphere ( M1nonlesioned ) , and sham tDCS-each for 20 mins .


The primary outcome measures were Purdue pegboard test scores for hand dexterity and response time in the color-word Stroop test for selective attention .


Pinch strength of the paretic hand was the secondary outcome .


Cathodal tDCS to M1nonlesioned significantly improved affected hand dexterity ( by 1.1 points on the Purdue pegboard unimanual test , P = 0.014 ) and selective attention ( 0.6 secs faster response time on the level 3 Stroop interference test for response inhibition , P = 0.017 ) , but not pinch strength .


The outcomes were not improved with anodal tDCS to M1lesioned or sham tDCS .


Twenty minutes of cathodal tDCS to M1nonlesioned can promote both paretic hand dexterity and selective attention in people with chronic stroke .


To assess the efficacy and safety of oral decernotinib ( VX-509 ; Vertex Pharmaceuticals ) monotherapy in a 12-week , randomized , double-blind , placebo-controlled , dose-ranging study of patients with rheumatoid arthritis ( RA ) .


Two hundred four adults with active RA who had been unsuccessfully treated with 1 disease-modifying antirheumatic drug were administered placebo tablets or decernotinib twice a day at dosages of 25 mg , 50 mg , 100 mg , or 150 mg .


Primary measures of efficacy at week 12 were the response rate according to the American College of Rheumatology 20 % improvement criteria ( ACR20 ) and mean change from baseline in the Disease Activity Score in 28 joints using the C-reactive protein level ( DAS28-CRP ) .


At week 12 , the ACR20 response rates were 39.0 % , 61.0 % , 65.0 % , and 65.9 % in the 25-mg , 50-mg , 100-mg , and 150-mg groups , respectively , and were significantly higher in the 50-mg group ( P = 0.007 ) and the 100-mg and 150-mg groups ( P = 0.002 ) as compared to the response rates in the placebo group ( 29.3 % ) .


The mean change from baseline in DAS28-CRP was greater in the 50-mg , 100-mg , and 150-mg groups as compared to the placebo group ( P < 0.001 ) .


Decernotinib treatment resulted in higher ACR50 and ACR70 response rates , more patients with DAS28-CRP scores < 2.6 , and improvements in the Health Assessment Questionnaire disability index as compared to placebo .


The most common adverse events in any decernotinib group were nausea ( 6.1 % ) , headache ( 4.3 % ) , an increase in levels of alanine aminotransferase ( 4.3 % ) , and hypercholesterolemia ( 3.7 % ) .


In the groups receiving decernotinib , there was an increased risk of infections and increased liver transaminase levels .


Decernotinib was efficacious in improving clinical signs and symptoms of RA at week 12 at dosages of 50-150 mg twice a day .


Infections and increases in liver transaminase and lipid levels were noted as potential safety signals .


The main goal of this randomized controlled single-blinded pilot study was to study whether , independent of weight loss , a Palaeolithic-type diet alters characteristics of the metabolic syndrome .


Next we searched for outcome variables that might become favourably influenced by a Paleolithic-type diet and may provide new insights in the pathophysiological mechanisms underlying the metabolic syndrome .


In addition , more information on feasibility and designing an innovative dietary research program on the basis of a Palaeolithic-type diet was obtained .


Thirty-four subjects , with at least two characteristics of the metabolic syndrome , were randomized to a two weeks Palaeolithic-type diet ( n = 18 ) or an isoenergetic healthy reference diet , based on the guidelines of the Dutch Health Council ( n = 14 ) .


Thirty-two subjects completed the study .


Measures were taken to keep bodyweight stable .


As primary outcomes oral glucose tolerance and characteristics of the metabolic syndrome ( abdominal circumference , blood pressure , glucose , lipids ) were measured .


Secondary outcomes were intestinal permeability , inflammation and salivary cortisol .


Data were collected at baseline and after the intervention .


Subjects were 53.5 ( SD9 .7 ) year old men ( n = 9 ) and women ( n = 25 ) with mean BMI of 31.8 ( SD5 .7 ) kg/m2 .


The Palaeolithic-type diet resulted in lower systolic blood pressure ( -9.1 mmHg ; P = 0.015 ) , diastolic blood pressure ( -5.2 mmHg ; P = 0.038 ) , total cholesterol ( -0.52 mmol/l ; P = 0.037 ) , triglycerides ( -0.89 mmol/l ; P = 0.001 ) and higher HDL-cholesterol ( +0.15 mmol/l ; P = 0.013 ) , compared to reference .


The number of characteristics of the metabolic syndrome decreased with 1.07 ( P = 0.010 ) upon the Palaeolithic-type diet , compared to reference .


Despite efforts to keep bodyweight stable , it decreased in the Palaeolithic group compared to reference ( -1.32 kg ; P = 0.012 ) .


However , favourable effects remained after post-hoc adjustments for this unintended weight loss .


No changes were observed for intestinal permeability , inflammation and salivary cortisol .


We conclude that consuming a Palaeolithic-type diet for two weeks improved several cardiovascular risk factors compared to a healthy reference diet in subjects with the metabolic syndrome .


Nederlands Trial Register NTR3002 .


To evaluate whether the addition of glyburide to diet therapy modifies pregnancy outcomes in women with mild gestational diabetes .


Women with at least two abnormal values on a 3-hour , 100-g oral glucose tolerance test according to National Diabetes Data Group criteria and fasting values less than 105 mg/dL between 24 and 30 weeks of gestation were randomized to blinded glyburide or placebo study drug .


All women were placed on a 35-kcal/kg diet and recorded four times daily capillary glucose measurements .


The study drug was titrated based on weekly maternal capillary glucose values with targets of less than 95 mg/dL ( 5.3 mmol/L ) and 120 mg/dL ( 6.7 mmol/L ) for fasting and 2-hour postprandial glucose measurements , respectively .


The primary study outcome was a 200-g birth weight decrement in neonates of women treated with glyburide .


The sample size estimate for this outcome was 334 total randomized women with a one-to-one allocation .


A total of 395 women were enrolled at a single center between September 2008 and October 2012 .


Women treated with glyburide had a significantly greater decline in fasting glucose values over the course of therapy .


However , there was no difference in the primary study outcome .


Specifically , the mean birth weight was 33 g lower in the group treated with glyburide ( P = .52 ) .


Although not powered to examine all outcomes associated with gestational diabetes , treatment with glyburide did not affect need for operative delivery , shoulder dystocia , clavicular fracture , Erb 's palsy , or neonatal hypoglycemia .


Four women in each group required insulin .


The addition of glyburide to diet therapy significantly improved maternal glycemic control over time when compared with placebo .


However , adding glyburide to diet did not decrease birth weight or improve maternal or neonatal outcomes in women with mild gestational diabetes .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT00744965 .


I.


Innovative cardiopulmonary bypass ( CPB ) settings have been developed in order to integrate the concepts of `` surface-coating , '' `` blood-filtration , '' and `` miniaturization . ''


To compare integrated and nonintegrated arterial line filters in terms of peri - and postoperative clinical variables , inflammatory response , and transfusion needs .


Thirty-six patients who underwent coronary bypass surgery were randomized into integrated ( Group In ) and nonintegrated arterial line filter ( Group NIn ) groups .


Arterial blood samples for the assessments of complete hemogram , biochemical screening , interleukin-6 , interleukin-2R , and C-reactive protein were analyzed before and after surgery .


Need for postoperative dialysis , inotropic therapy and transfusion , in addition to extubation time , total amount of drainage ( mL ) , length of intensive care unit , and hospital stay , and mortality rates was also recorded for each patient .


Prime volume was significantly higher and mean intraoperative hematocrit value was lower in Group NIn , but need for erythrocyte transfusion was significantly higher in Group NIn .


C-reactive protein values did not differ significantly except for postoperative second day 's results , which were found significantly lower in Group In than in Group NIn .


Intraoperative hematocrit levels were higher and need for postoperative erythrocyte transfusion was decreased in Group In .


Low back pain ( LBP ) is a prevalent condition and a socioeconomic problem in many countries .


Due to its recurrent nature , the prevention of further episodes ( secondary prevention ) , seems logical .


Furthermore , when the condition is persistent , the minimization of symptoms and prevention of deterioration ( tertiary prevention ) , is equally important .


Research has largely focused on treatment methods for symptomatic episodes , and little is known about preventive treatment strategies .


This study protocol describes a randomized controlled clinical trial in a multicenter setting investigating the effect and cost-effectiveness of preventive manual care ( chiropractic maintenance care ) in a population of patients with recurrent or persistent LBP.Four hundred consecutive study subjects with recurrent or persistent LBP will be recruited from chiropractic clinics in Sweden .