In addition , previous studies of the therapeutic efficacy of PLIF and PLF had several weaknesses , so they could not provide clear data on the therapeutic outcomes of each treatment .


Of the 85 patients screened for this study , 4 did not meet the study criteria .


Thus , 81 patients were enrolled and randomly assigned into group A ( PLF , n = 39 ) or group B ( PLIF , n = 42 ) .


The primary outcome measure was the fusion rate based on dynamic radiographs and computed tomographic scans at postoperative 1 and 2 years .


The secondary outcome measures were ( 1 ) clinical outcomes as assessed with a visual analogue scale and the Oswestry Disability Index , ( 2 ) surgical outcomes , and ( 3 ) additional outcomes such as infection and metal failure .


No patients were lost to follow-up .


The fusion rate was similar between groups : fusion occurred in 84.6 % ( 33/39 ) in group A and 85.7 % ( 36/42 ) in group B at 1 year after surgery ( P = 0.86 ) , and 89.7 % ( 35/39 ) in group A and 90.4 % ( 38/42 ) in group B at 2 years after surgery ( P = 0.93 ) .


Postoperative pain levels and functional outcomes did not differ significantly between groups at any of the regular follow-up visits .


The prevalence of complications also did not differ significantly between groups ; the only serious complication ( deep infection ) occurred in 1 patient in the PLIF group .


Both PLF and PLIF are viable surgical options for patients with isthmic spondylolisthesis 60 years or younger .


Constraint-induced movement therapy ( CIMT ) is recommended for patients with upper limb dysfunction after stroke , yet evidence to support the implementation of CIMT in ambulatory care is insufficient .


We assessed the efficacy of home CIMT , a modified form of CIMT that trains arm use in daily activities within the home environment .


In this parallel , cluster-randomised controlled trial , we selected 71 therapy practices in northern Germany that treat adult patients with upper limb dysfunction after stroke .


Practices were stratified by region and randomly allocated by an external biometrician ( 1:1 , block size of four ) using a computer-generated sequence .


37 practices were randomly assigned to provide 4 weeks of home CIMT and 34 practices to provide 4 weeks of standard therapy .


Eligible patients had mild to moderate impairment of arm function at least 6 months after stroke and a friend or family member willing to participate as a non-professional coach .


Patients of both groups received 5 h of professional therapist contact in 4 weeks .


In the home CIMT group , therapists used the contact time to instruct and supervise patients and coaches in home CIMT .


Patients in the standard therapy group received conventional physical or occupational therapy , but additional home training was not obligatory .


All assessments were done by masked outcome assessors at baseline , after 4 weeks of intervention , and at 6 month follow-up .


The primary outcomes were quality of movement , assessed by the Motor Activity Log ( MAL-QOM , assessor-assisted self-reported ) , and performance time , assessed by the Wolf Motor Function Test ( WMFT-PT , assessor-reported ) .


Primary outcomes were tested hierarchically after 4 weeks of intervention and analysed by intention to treat , using mixed linear models .


This trial is registered with ClinicalTrials.gov , NCT01343602 .


Between July 11 , 2011 , and June 4 , 2013 , 85 of 156 enrolled patients were assigned home CIMT and 71 patients were assigned standard therapy .


82 ( 96 % ) patients in the home CIMT group and 71 ( 100 % ) patients in the standard therapy group completed treatment and were assessed at 4 weeks .


Patients in both groups improved in quality of movement ( MAL-QOM ; change from baseline 056 , 95 % CI 041-071 , p < 00001 for home CIMT vs 031 , 015-046 , p = 00003 for standard therapy ) .


Patients in the home CIMT group improved more than patients in the standard therapy group ( between-group difference 026 , 95 % CI 005-046 ; p = 00156 ) .


Both groups also improved in motor function performance time ( WMFT-PT ; change from baseline -2560 % , 95 % CI -3675 to -1249 , p = 00006 for home CIMT vs -2752 % , -3894 to -1394 , p = 00004 for standard therapy ) , but the extent of improvement did not differ between groups ( 265 % , -1794 to 2840 ; p = 08152 ) .


Nine adverse events ( of which six were serious ) were reported in the home CIMT group and ten ( of which seven were serious ) in the standard therapy group ; however , none was deemed related to the study intervention .


Home-based CIMT can enhance the perceived use of the stroke-affected arm in daily activities more effectively than conventional therapy , but was not superior with respect to motor function .


Further research is needed to confirm whether home CIMT leads to clinically significant improvements and if so to identify patients that are most likely to benefit .


German Federal Ministry of Education and Research .


Our main purpose was to compare safety and efficacy in the treatment of progressive keratoconus with `` epithelium-on '' and `` epithelium-off '' corneal collagen cross-linking ( CXL ) .


Our secondary purpose was to evaluate efficacy of CXL when hypotonic 0.5 % riboflavin is used as photosensitizer .


One eye of 20 patients with bilateral progressive keratoconus was randomly treated for `` epithelium-on '' CXL ( group 1 ) while the fellow eye underwent `` epithelium-off '' CXL ( group 2 ) .


Hypotonic 0.5 % riboflavin was used in both groups .


Visual acuity , refraction , corneal topography , and wavefront aberrometry were evaluated at baseline and after 1 , 6 , and 12 months .


Specular microscopy was performed on 10 patients preoperatively and after 12 months .


Postoperative pain was evaluated using a patient questionnaire .


Uncorrected and corrected distance visual acuity improved significantly in both groups .


Refraction , topography , and aberrometry showed nonsignificant changes from the preoperative status throughout the 12-month follow-up in both groups .


Moreover , the outcomes between the groups were comparable at all follow-up points .


Endothelial cell-count was stable .


Postoperative pain length was shorter in group 1 ( P < 0.001 ) .


`` Epithelium-on '' and `` epithelium-off '' CXL using hypotonic 0.5 % riboflavin were equally safe and effective in stabilization of keratoconus .


Topography and aberrometry outcomes in both groups failed to show any significant improvements .


This study is registered at ClinicalTrials.gov : NCT01181219 .


High-dose interferon ( IFN ) for 1 year ( HDI ) is the US Food and Drug Administration-approved adjuvant therapy for patients with high-risk melanoma .


Efforts to modify IFN dose and schedule have not improved efficacy .


We sought to determine whether a shorter course of biochemotherapy would be more effective .


S0008 ( S0008 : Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma ) was an Intergroup phase III trial that enrolled high-risk patients ( stage IIIA-N2a through IIIC-N3 ) , randomly assigning them to receive either HDI or biochemotherapy consisting of dacarbazine , cisplatin , vinblastine , interleukin-2 , IFN alfa-2b ( IFN -- 2b ) and granulocyte colony-stimulating factor given every 21 days for three cycles .


Coprimary end points were relapse-free survival ( RFS ) and overall survival ( OS ) .


In all , 432 patients were enrolled .


Grade 3 and 4 adverse events occurred in 57 % and 7 % of HDI patients and 36 % and 40 % of biochemotherapy patients , respectively .


At a median follow-up of 7.2 years , biochemotherapy improved RFS ( hazard ratio [ HR ] , 0.75 ; 95 % CI , 0.58 to 0.97 ; P = .015 ) , with a median RFS of 4.0 years ( 95 % CI , 1.9 years to not reached [ NR ] ) versus 1.9 years for HDI ( 95 % CI , 1.2 to 2.8 years ) and a 5-year RFS of 48 % versus 39 % .


Median OS was not different ( HR , 0.98 ; 95 % CI , 0.74 to 1.31 ; P = .55 ) , with a median OS of 9.9 years ( 95 % CI , 4.62 years to NR ) for biochemotherapy versus 6.7 years ( 95 % CI , 4.5 years to NR ) for HDI and a 5-year OS of 56 % for both arms .


Biochemotherapy is a shorter , alternative adjuvant treatment for patients with high-risk melanoma that provides statistically significant improvement in RFS but no difference in OS and more toxicity compared with HDI .


Screen-based activities , such as watching television ( TV ) , playing video games , and using computers , are common sedentary behaviors among young people and have been linked with increased energy intake and overweight .


Previous home-based sedentary behaviour interventions have been limited by focusing primarily on the child , small sample sizes , and short follow-up periods .


The SWITCH ( Screen-Time Weight-loss Intervention Targeting Children at Home ) study aimed to determine the effect of a home-based , family-delivered intervention to reduce screen-based sedentary behaviour on body composition , sedentary behaviour , physical activity , and diet over 24 weeks in overweight and obese children .


A two-arm , parallel , randomized controlled trial was conducted .


Children and their primary caregiver living in Auckland , New Zealand were recruited via schools , community centres , and word of mouth .


The intervention , delivered over 20 weeks , consisted of a face-to-face meeting with the parent/caregiver and the child to deliver intervention content , which focused on training and educating them to use a wide range of strategies designed to reduce their child 's screen time .


Families were given Time Machine TV monitoring devices to assist with allocating screen time , activity packages to promote alternative activities , online support via a website , and monthly newsletters .


Control participants were given the intervention material on completion of follow-up .


The primary outcome was change in children 's BMI z-score from baseline to 24 weeks .


Children ( n = 251 ) aged 9-12 years and their primary caregiver were randomized to receive the SWITCH intervention ( n = 127 ) or no intervention ( controls ; n = 124 ) .


There was no significant difference in change of zBMI between the intervention and control groups , although a favorable trend was observed ( -0.016 ; 95 % CI : -0.084 , 0.051 ; p = 0.64 ) .


There were also no significant differences on secondary outcomes , except for a trend towards increased children 's moderate intensity physical activity in the intervention group ( 24.3 min/d ; 95 % CI : -0.94 , 49.51 ; p = 0.06 ) .


A home-based , family-delivered intervention to reduce all leisure-time screen use had no significant effect on screen-time or on BMI at 24 weeks in overweight and obese children aged 9-12 years .


Australian New Zealand Clinical Trials RegistryWebsite : http://www.anzctr.org.au


ACTRN12611000164998 .


We have previously reported that 1year of supervised resistance + impact training stopped bone loss and built muscle strength in older breast cancer survivors .


The purpose of this study was to determine whether these benefits persisted 1year after completion of the intervention .


Sixty-seven women from the original trial completed baseline and post-intervention body composition and muscle strength tests , and 44 women were available 1year later for follow-up assessments .


Bone mineral density ( grams per square centimeter ) of the hip and spine , muscle mass ( kilograms ) , and fat mass ( kilograms ) were measured by dual-energy X-ray absorptiometry and maximal upper and lower body strength were measured by one-repetition maximum tests ( kilograms ) .


We compared between group changes across baseline ( pre-intervention ) , 1 ( post-intervention ) , and 2years ( 1year follow up ) on study outcomes using repeated-measures analysis of covariance , adjusting for age .


Significant group by time interactions were found for spine bone mineral density ( BMD ) ( p < 0.01 ) and lower body muscle strength ( p < 0.05 ) , with a trend for upper body muscle strength ( p = 0.05 ) .


Spine BMD remained stable across intervention and follow-up periods in exercisers compared with continuous losses in controls across 1 - and 2-year periods .


In contrast , lower body strength increased in exercisers across the intervention , but decreased to near-baseline levels during follow-up compared with no change over either time period in controls .


Our data suggest that spine BMD can be preserved in older breast cancer survivors even after formal exercise training stops ; however , muscle strength is not similarly maintained and may require continued participation in a supervised exercise program .


Exercise programs aimed at improving musculoskeletal health should be considered in the long-term care plan for breast cancer survivors .


Control of cervical cancer in developing countries has been hampered by a failure to achieve high screening uptake .


HPV DNA self-collection could increase screening coverage , but implementation of this technology is difficult in countries of middle and low income .


We investigated whether offering HPV DNA self-collection during routine home visits by community health workers could increase cervical screening .


We did a population-based cluster-randomised trial in the province of Jujuy , Argentina , between July 1 , 2012 , and Dec 31 , 2012 .


Community health workers were eligible for the study if they scored highly on a performance score , and women aged 30 years or older were eligible for enrolment by the community health worker .


200 community health workers were randomly allocated in a 1:1 ratio to either the intervention group ( offered women the chance to self-collect a sample for cervical screening during a home visit ) or the control group ( advised women to attend a health clinic for cervical screening ) .


The primary outcome was screening uptake , measured as the proportion of women having any HPV screening test within 6 months of the community health worker visit .


Analysis was by intention to treat .


This trial is registered with ClinicalTrials.gov , number NCT02095561 .


100 community health workers were randomly allocated to the intervention group and 100 were assigned to the control group ; nine did not take part .


191 participating community health workers ( 94 in the intervention group and 97 in the control group ) initially contacted 7650 women ; of 3632 women contacted by community health workers in the intervention group , 3049 agreed to participate ; of 4018 women contacted by community health workers in the control group , 2964 agreed to participate .


2618 ( 86 % ) of 3049 women in the intervention group had any HPV test within 6 months of the community health worker visit , compared with 599 ( 20 % ) of 2964 in the control group ( risk ratio 402 , 95 % CI 344-471 ) .


Offering self-collection of samples for HPV testing by community health workers during home visits resulted in a four-fold increase in screening uptake , showing that this strategy is effective to improve cervical screening coverage .


This intervention reduces women 's barriers to screening and results in a substantial and rapid increase in coverage .


Our findings suggest that HPV testing could be extended throughout Argentina and in other countries to increase cervical screening coverage .


Instituto Nacional del Cncer ( Argentina ) .


Second-line chemotherapy for advanced non-small cell lung cancer ( NSCLC ) improves survival modestly but new strategies are needed .


This trial was designed to evaluate an antivascular endothelial growth factor strategy with or without standard chemotherapy in previously treated NSCLC .


Patients with stage IIIB/IV NSCLC with performance status 0 to 1 progressive after first-line chemotherapy were eligible for randomization to pemetrexed , sunitinib , or the combination .


Patients were stratified by performance status , stage , and sex .


Primary objective was 18-week progression-free survival ( PFS ) rate ; secondary objectives included response , overall survival ( OS ) , and toxicity .


Target accrual was 225 .


The study was terminated early because of decreasing accrual rates .


Between April 2008 and September 2011 , 130 patients were registered and randomized ; of this , 125 patients were treated .


Baseline characteristics in the three arms were well balanced .


Toxicity was higher in the sunitinib-containing arms .


The 18-week PFS rate in the pemetrexed , sunitinib , and combination arms was 54 % ( 95 % confidence interval [ CI ] , 40-71 ) , 37 % ( 95 % CI , 25-54 ) , and 48 % ( 95 % CI , 35-66 ) , respectively ( p = 0.25 ) .


Median PFS in the pemetrexed , sunitinib , and combination arms in months was 4.9 ( 2.1-8 .8 ) , 3.3 ( 2.3-4 .2 ) , and 3.7 ( 2.5-5 .8 ) , respectively ( p = 0.18 ) .


There was an overall statistically significant difference in OS between the three arms : median OS in months was 10.5 ( 8.3-20 .2 ) for pemetrexed , 8.0 ( 6.8-13 .5 ) for sunitinib , and 6.7 ( 4.1-10 .1 ) for the combination ( p = 0.03 ) .


Pemetrexed had a superior toxicity profile to either sunitinib or the combination of pemetrexed and sunitinib .


The 18-week PFS rate was not significantly different between the arms .


OS was significantly better with pemetrexed alone compared with the two sunitinib-containing arms , with the doublet performing worst for OS .


Ex-PRESS shunt is an alternative filtration procedure to trabeculectomy .


This study aimed to compare the 1-year cost differences between the 2 operations .


Subjects were enrolled in a randomized controlled trial comparing Ex-PRESS to trabeculectomy .


Surgical cost difference and 1-year postoperative costs ( follow-up visits , additional procedures , and medications ) were determined and compared .


The 95 % confidence interval of incremental cost-effectiveness ratio was estimated using bootstrap method .


Forty-three subjects with 1-year follow-up were included .


Success rate was not significantly different for Ex-PRESS ( 65 % ) versus trabeculectomy ( 55 % , P = 0.49 ) .


Ex-PRESS had a net surgical cost of $ 956 greater than trabeculectomy .


There was no significant difference in the overall postoperative cost [ median ( interquartile range ) ; $ 485 ( 337 , 822 ) vs. $ 609 ( 387 , 820 ) , P = 0.78 ] , cost of follow-up visits [ $ 303 ( 275 , 358 ) vs. $ 317 ( 275 , 385 ) , P = 0.75 ] , additional procedures [ $ 182 ( 0 , 365 ) vs. $ 182 ( 0 , 365 ) , P = 0.69 ] , or glaucoma medication [ $ 0 ( 0 , 68 ) vs. $ 0 ( 0 , 90 ) , P = 0.8 ] for Ex-PRESS versus trabeculectomy , respectively .


The overall 1-year cost was significantly greater for Ex-PRESS and the incremental cost-effectiveness ratio was $ 9625 ( 95 % confidence interval , $ 2435-548 ,084 ) .


Ex-PRESS is associated with greater surgical cost compared with trabeculectomy .


This needs to be considered in conjunction with efficacy and safety if Ex-PRESS is to supersede trabeculectomy .


Midostaurin , a multitargeted tyrosine kinase inhibitor , is primarily metabolized by CYP3A4 .


This midostaurin drug-drug interaction study assessed the dynamic response and clinical usefulness of urinary 6-hydroxycortisol to cortisol ratio ( 6CR ) and plasma 4-hydroxycholesterol ( 4HC ) for monitoring CYP3A4 activity in the presence or absence of rifampicin , a strong CYP3A4 inducer .


Forty healthy adults were randomized into groups for either placebo or treatment with rifampicin 600mg QD for 14days .


All participants received midostaurin 50mg on day 9 .


Midostaurin plasma pharmacokinetic parameters were assessed .


Urinary 6CR and plasma 4HC levels were measured on days 1 , 9 , 11 , and 15 .


Both markers remained stable over time in the control group and increased significantly in the rifampicin group .


In the rifampicin group , the median increases ( vs day 1 ) on days 9 , 11 , and 15 were 4.1 - , 5.2 - , and 4.7-fold , respectively , for 6CR and 3.4 - , 4.1 - , and 4.7-fold , respectively , for 4HC .


Inter - and intrasubject variabilities in the control group were 45.6 % and 30.5 % , respectively , for 6CR , and 33.8 % and 7.5 % , respectively , for 4HC .


Baseline midostaurin area under the concentration-time curve ( AUC ) correlated with 4HC levels ( = -0.72 ; P = .003 ) , but not with 6CR ( = 0.0925 ; P = .6981 ) .


Both 6CR and 4HC levels showed a good dynamic response range upon strong CYP3A4 induction with rifampicin .


Because of lower inter - and intrasubject variability , 4HC appeared more reliable and better predictive of CYP3A4 activity compared with 6CR .


The data from our study further support the clinical utility of these biomarkers .


Chronic rhinosinusitis ( CRS ) is an inflammatory process that causes different clinical symptoms : nasal blockage and congestion , posterior and anterior nasal drip , and smell disorder ranging from reduced olfaction ( hyposmia ) to complete loss of smell ( anosmia ) .


It has been suggested that mechanical blockage of olfactory clef after polypectomy is responsible for the persistent impairment of olfaction in some cases .


The aim of this study was to evaluate the efficacy of application of steroids at the olfactory cleft in improving olfactory function in patients who underwent sinus surgery .


A double-blind , randomized controlled trial was conducted in Yazd , Iran , between March and December 2012 .


Eligible patients who had CRS with polyposis and underwent functional endoscopic sinus surgery were recruited .


An absorbable gelatin dressing combined with triamcinolone ( case ) or normal saline ( control ) was applied at the site of surgery .


Olfaction was assessed by butanol threshold tests before and 8 weeks after surgery .


A total of 60 patients were enrolled into the study and were equally divided into triamcinolone and control groups .


Subjects in both arms of trial experienced augmentation of smell function throughout the study ; however , patients who received triamcinolone had better improvement after 8 weeks ( p = 0.007 ) .


Complete remission rate was 100 % in the triamcinolone group and the corresponding figure was 76 % in the control group .


We suggest that application of triamcinolone at the olfactory cleft can boost the effect of surgery in restoring olfactory function .


Previous pharmacokinetic trials suggested that 40 mg subcutaneous enoxaparin once daily provided inadequate thromboprophylaxis for intensive care unit patients .


Critically ill patients with acute kidney injury are at increased risk of venous thromboembolism and yet are often excluded from these trials .


We hypothesized that for critically ill patients with acute kidney injury receiving continuous renal replacement therapy , a dose of 1 mg/kg enoxaparin subcutaneously once daily would improve thromboprophylaxis without increasing the risk of bleeding .


In addition , we seek to utilize urine output prior to discontinuing dialysis , and low neutrophil gelatinase-associated lipocalin in dialysis-free intervals , as markers of renal recovery .


In a multicenter , double-blind randomized controlled trial in progress at three intensive care units across Denmark , we randomly assign eligible critically ill adults with acute kidney injury into a treatment ( 1 mg/kg enoxaparin subcutaneously once daily ) or control arm ( 40 mg enoxaparin subcutaneously once daily ) upon commencement of continuous renal replacement therapy.We calculated that with 133 patients in each group , the study would have 80 % power to show a 40 % reduction in the relative risk of venous thromboembolism with 1 mg/kg enoxaparin , at a two-sided alpha level of 0.05 .


An interim analysis will be conducted after the first 67 patients have been included in each group.Enrolment began in March 2013 , and will continue for two years .


The primary outcome is the occurrence of venous thromboembolism .


Secondary outcomes include anti-factor Xa activity , bleeding , heparin-induced thrombocytopenia , filter lifespan , length of stay , ventilator free days , and mortality .


We will also monitor neutrophil gelatinase-associated lipocalin and urine volume to determine whether they can be used as prognostic factors for renal recovery .


Critically ill unit patients with acute kidney injury present a particular challenge in the provision of thromboprophylaxis .


This study hopes to add to the growing evidence that the existing recommendation of 40 mg enoxaparin is inadequate and that 1 mg/kg is both safe and effective for thromboprophylaxis.In addition , the study seeks to identify predictors of renal recovery allowing for the proper utilization of resources .


EU Clinical Trials Register : EudraCT number : 2012-004368-23 , 25 September 2012 .


The nucleus accumbens ( NAc ) works as a key brain structure of the reward system , in which reward-related neural activity is well correlated with dopamine release from mesolimbic dopaminergic neurons .


Since modafinil can modulate dopaminergic transmission through re-uptake inhibition of dopamine , we investigated whether modafinil affects the reward-related brain activity in the NAc in healthy subjects .


Twenty healthy participants underwent two series of functional magnetic resonance imaging while performing monetary incentive delay task in which they were cued to anticipate and respond to a rapidly presented target to gain or avoid losing varying amounts of money , under modafinil or placebo condition .


Blood oxygenation-level dependent ( BOLD ) activation signals during gain and loss anticipations were analyzed in the NAc as an a priori region of interest as well as the whole brain .


Modafinil significantly changed subjective feelings toward positive ones .


The activation of BOLD signals was observed during gain anticipation under the placebo and modafinil conditions in the left and bilateral NAc , respectively .


The modafinil condition showed significantly higher BOLD signal change at the highest gain ( +500 ) cue compared to the placebo condition .


The present study showed that modafinil affects reward processing in the NAc in healthy subjects through enhancing more positive anticipation , and it may provide a basis for the use of this drug for treating anhedonia observed in psychiatric disorders .


Risk factors associated with increased carriage rates are the same in children with recurrent acute otitis media ( rAOM ) as in healthy children .


These are also known to be risk factors for the development of AOM itself .


The aim of this study was to describe risk factors for nasopharyngeal carriage in a cohort of young children at high risk of developing rAOM .


Children with an onset of AOM before 6 months of age , indicating an 80 % risk of developing rAOM , were enrolled in a vaccination trial on heptavalent PCV .


These children were monitored for 3 years during healthy and AOM periods with nasopharyngeal cultures , physical examinations , and questionnaires .


A total of 109 children were included at a mean age of 5 months ; 105 were followed for 3 years , 89 ( 82 % ) of whom developed rAOM .


Risk factors associated with increased carriage of all major AOM pathogens were age < 2 years , concurrent AOM , and fulfilment of rAOM criteria .


Having siblings in day care was associated with increased carriage of Streptococcus pneumoniae and Haemophilus influenzae , recent antibiotic treatment was associated with H. influenzae and Moraxella catarrhalis carriage , and winter season was associated with M. catarrhalis carriage alone .


To compare surgical pleth index ( SPI ) - guided analgesia with conventional analgesia by evaluating intraoperative analgesic requirements , postoperative pain , and emergence agitation in children .


This study was designed as a parallel , two-arm , double-blind , randomized controlled trial .


Forty-five children undergoing elective adenotonsillectomy were randomly allocated to SPI-guided group ( SPI-guided analgesia group , n = 21 ) or control group ( conventional analgesia group , n = 24 ) .


Anesthesia was maintained with sevoflurane 2 to 3 vol % in 50 % nitrous oxide and oxygen to achieve state entropy between 40 and 60 .


Intraoperative fentanyl 0.5 g/kg was administered for the first event persisting 3 min and subsequent events persisting 5 min .


An event was defined as an SPI over 50 ( SPI-guided group ) or a blood pressure or heart rate 20 % above the baseline ( control group ) .


The primary outcome was intraoperative fentanyl requirement .


Secondary outcomes included intraoperative sevoflurane consumption , postoperative emergence agitation and pain score , and postoperative rescue analgesic requirements .


Intraoperative fentanyl requirement was lower in SPI-guided group than in control group ( 0.43 0.53 vs. 1.73 0.59 g/kg ; P < 0.001 ) .


Intraoperative sevoflurane consumption was similar .


The proportion of patients with high emergence agitation scores ( 4 to 5 ) was greater in SPI-guided group ( 61.9 vs. 25.0 % ; P = 0.01 ) .


The postoperative pain score and rescue fentanyl consumption were higher in SPI-guided group ( 7 [ 4.5 ; 9 ] vs. 3 [ 2 ; 6.75 ] ; P = 0.002 ; 0.50 0.34 vs. 0.29 0.30 g/kg ; P = 0.04 ) .


As currently constructed , SPI does not appear to be valid in children .


This may be due to both differences in blood vessel distensibility and baseline increased heart rates in children versus adults .


Anxiety and depression are common co-morbidities in patients with chronic obstructive pulmonary disease ( COPD ) .


Serious implications can result from psychological difficulties in COPD including reduced survival , lower quality of life , and reduced physical and social functioning , increased use of health care resources and are associated with unhealthy behaviours such as smoking .


Cognitive behavioural therapy ( CBT ) is a psychological intervention which is recommended for the treatment of many mental health problems including anxiety and depression .


Unfortunately access to trained CBT therapists is limited .


The aim of this study is to test the hypothesis that CBT delivered by respiratory nurses is effective in the COPD population .


In this paper the design of the Newcastle Chronic Obstructive Pulmonary Disease Cognitive Behavioural Therapy Study ( Newcastle COPD CBT Care Study ) is described .


This is a prospective open randomised controlled trial comparing CBT with self-help leaflets .


The primary outcome measure is the Hospital Anxiety & Depression Scale ( HADS ) - anxiety subscale .


Secondary outcome measures include disease specific quality of life COPD Assessment Tool ( CAT ) , generic quality of life ( EQ5D ) and HADS-depression subscale .


Patients will be followed up at three , six and 12 months following randomisation .


This is the first randomised controlled trial to evaluate the use of cognitive behavioural therapy undertaken by respiratory nurses .


Recruitment has commenced and should be complete by February 2014 .


Current Controlled Trials , ISRCTN55206395 .


We aimed to investigate the efficacy and tolerability of empagliflozin , an oral , potent , and selective inhibitor of sodium-glucose co-transporter 2 , in patients with type 2 diabetes who had not received drug treatment in the preceding 12 weeks .


In our multicentre , randomised , placebo-controlled , phase 3 trial , we enrolled adults ( aged 18 years ) who had not received oral or injected anti-diabetes treatment in the previous 12 weeks .


Eligible patients had HbA1c concentrations of 7-10 % .


We randomly allocated patients ( 1:1:1:1 ) with a computer-generated random sequence , stratified by region , HbA1c , and estimated glomerular filtration rate at screening , to placebo , empagliflozin 10 mg , empagliflozin 25 mg , or sitagliptin 100 mg once daily for 24 weeks .


Patients and investigators were masked to treatment assignment .


The primary endpoint was change from baseline in HbA1c at week 24 by ANCOVA in all randomly allocated patients who were treated with at least one dose of study drug and had a baseline HbA1c value .


This study is completed and registered with ClinicalTrials.gov , number NCT01177813 .


Between Aug 12 , 2010 , and March 19 , 2012 , we randomly allocated 228 patients to receive placebo , 224 to receive empagliflozin 10 mg , 224 to receive empagliflozin 25 mg , and 223 to receive sitagliptin .


Compared with placebo , adjusted mean differences in change from baseline HbA1c at week 24 were -074 % ( 95 % CI -088 to -059 ; p < 00001 ) for empagliflozin 10 mg , -085 % ( -099 to -071 ; p < 00001 ) for empagliflozin 25 mg , and -073 % ( -088 to -059 ; p < 00001 ) for sitagliptin .


140 ( 61 % ) patients in the placebo group reported adverse events ( four [ 2 % ] severe and six [ 3 % ] serious ) , as did 123 ( 55 % ) patients in the empagliflozin 10 mg group ( eight [ 4 % ] severe and eight [ 4 % ] serious ) , 135 ( 60 % ) patients in the empagliflozin 25 mg group ( seven [ 3 % ] severe and five [ 2 % ] serious ) , and 119 ( 53 % ) patients in the sitagliptin group ( five [ 2 % ] severe and six [ 3 % ] serious ) .


Empagliflozin provides a tolerable and efficacious strategy to reduce HbA1c in patients with type 2 diabetes who had not previously received drug treatment .


Boehringer Ingelheim and Eli Lilly .


The purpose of this study was to prospectively evaluate the contrast enhancement , vascular depiction , image quality , and radiation dose of low-tube-voltage whole-body CT angiography ( CTA ) performed with low-concentration iodinated contrast material .


Whole-body CTA was performed on 109 patients with a 64-MDCT scanner .


Patients were randomized into three groups : CTA with 240-mg/mL contrast material at 80 kVp ( 240-80 group ) , 300-mg/mL at 80 kVp ( 300-80 group ) , and 370-mg/mL at 120 kVp ( 370-120 group ) .


Signal-to-noise ratio ( SNR ) , arterial depiction , image quality , and radiation dose were assessed .


Figure of merit was computed to normalize signal-to-noise ratio , estimated effective dose , and iodine weight .


In the 240-80 group , the mean load of administered iodine was 21.6 g ; for the 300-80 group , 26.8 g ; and the 370-120 group , 34.0 g ( p < 0.05 ) .


The ranges of mean vascular enhancement were 508-521 HU , 546-593 HU , and 435-442 HU ( p < 0.05 ) .


Arterial depiction and image quality were comparable for the 240-80 and 370-120 groups and were greater for the 300-80 group than the other two groups in selected arteries ( p < 0.05 ) .


Effective dose was higher ( p < 0.05 ) in the 370-120 group ( 2.8-5 .4 mSv ) than in the others ( 2.3-4 .3 mSv ) .


The figure of merit in the 240-80 group was greater than ( p < 0.05 ) or comparable to that in the 370-120 group .


Use of 240-mg/mL contrast material at 80 kVp seems appropriate for routine whole-body CTA and beneficial for reduction of iodine load and radiation dose , whereas use of 300-mg/mL contrast material may marginally improve delineation of selected small arteries .


Few studies examine psychosocial factors influencing the adoption of healthy behaviors among hypertensive patients .


The effect of discrimination on health behaviors remains untested .


To examine the influence of discrimination on adoption of healthy behaviors among low-income Black hypertensive patients .


Black patients ( N = 930 ) in community-based primary care practices enrolled in the CAATCH trial .


Mixed effects regressions examined associations between perceived discrimination and change in medication adherence , diet , and physical activity from baseline to 12 months , controlling for intervention , gender , age , income , and education .


Patients were low-income , high-school-educated , with a mean age of 57 years .


Greater discrimination was associated with worse diet and lower medication adherence at baseline .


Discrimination was associated with greater improvement in healthy eating behaviors over the course of the 12-month trial .


Prior exposure to discrimination was associated with unhealthy behaviors at baseline , but did not negatively influence the adoption of health behaviors over time .


To evaluate the efficacy of spinal needle aspiration for symptom improvement in awake patients with epiglottic abscess ( EA ) .


Prospective randomized controlled study .


Tertiary center .


Twenty-two patients who were diagnosed with EA were randomly allocated to group A ( needle aspiration and antibiotics ) or group B ( antibiotics only ) .


Patients ' characteristics , laryngoscopic findings of epiglottic swelling and arytenoid swelling by scope classification , and initial laboratory findings were analyzed .


Needle aspiration was done under local anesthesia in awake patients using an 18-gauge spinal needle and indirect laryngoscope .


Changes in the following symptoms during hospital stay were assessed : sore throat , hoarseness , dyspnea , odynophagia , and dysphagia .


Eleven patients were treated with needle aspiration and antibiotics , and 11 patients were treated with antibiotics only .


There was no statistically significant difference between the 2 groups regarding age , sex , white blood cell count , C-reactive protein , presenting clinical symptoms , abscess size , and scope classification at time of diagnosis .


Patients in both groups had significant improvement in all clinical symptoms .


While there were no between-group differences in improvement for any of the symptoms , the length of hospitalization was significantly lower in group A ( 4.0 1.9 days ) than in group B ( 5.7 1.2 days ) ( P = .037 ) .


We did not find any significant additional benefit of needle aspiration for the treatment of EA , with the exception that needle aspiration reduced the length of hospitalization .


Further proof with a large-scale study is needed .


Calf vein diameters during compression with two different stocking brands are assessed as well as quality of life .


60 subjects ( 53 female ) with painful legs were randomized to either wearing the Venotrain micro ( VM ) or the Venotrain ulcertec ( VU ) compression stocking for 2 weeks .


All calf - veins were assessed in cross - sectional plane by Duplexsonography native and through the compression stockings .


The diameters of 2 gastrocnemius muscle - veins ( GV ) , the short saphenous vein ( SSV ) and the posterior tibial vein ( PTV ) were compared intra - individually , with and without compression .


Mean diameters ( SD ) decreased significantly under compression ( p < 0.0001 ) in the standing position : in the antero-posterior ( ap ) plane of the GV by 6.5 ( 16.6 ) % under VU and 8.2 ( 16.5 ) % under VM , in the SSV 9.7 ( 15.8 ) % under VU and 5.7 ( 19.2 ) % under VM .


No significant change ( p = 0.48 ) was seen in the PTV .


In the prone position the relative ap - diameter changes in the medial GV were significantly smaller for the VM ( 37.5 51.0 % ) compared to the VU compression stocking ( 52.4 51.8 % ) ( p = 0.016 ) .


The quality of life assessment scores improved significantly for the VU - and the VM - compression stocking .


Venous diameters did not correlate with quality of life scores .


Intra - individually tested the calf muscle vein diameters decrease under compression , more pronounced in the prone than in the standing position .


In the ankle area the PTV does not decrease in standing subjects .


Quality of life assessed increases for both compression stockings .


Results of previous studies suggest that - adrenoreceptor activation may augment pain , and that - adrenoreceptor antagonists may be effective in reducing pain , particularly in individuals not homozygous for the catechol-O-methyltransferase ( COMT ) high-activity haplotype .


Consenting patients admitted for thermal burn injury at participating burn centers were genotyped ; those who were not high-activity COMT homozygotes were randomized to propranolol 240 mg/d or placebo .


Primary outcomes were study feasibility ( consent rate , protocol completion rate ) and pain scores on study days 5 to 19 .


Secondary outcomes assessed pain and posttraumatic stress disorder symptoms 6 weeks postinjury .


Seventy-seven percent ( 61/79 ) of eligible patients were consented and genotyped , and 77 % ( 47/61 ) were genotype eligible and randomized .


Ninety-one percent ( 43/47 ) tolerated study drug and completed primary outcome assessments .


In intention-to-treat and per-protocol analyses , patients randomized to propranolol had worse pain scores on study days 5 to 19 .


Genotype-specific pain medication interventions are feasible in hospitalized burn patients .


Propranolol is unlikely to be a useful analgesic during the first few weeks after burn injury .


New treatment options are needed for second-line therapy in patients with NSCLC .


This was a phase Ib/II study in patients with nonsquamous NSCLC in whom 1 previous platinum-based chemotherapy regimen had failed .


Fifteen patients were enrolled in a dose escalation of eribulin mesylate in combination with pemetrexed ( E+P ) .


In phase II ( n = 80 ) , E+P at the maximum tolerated dose was compared with P.


In phase Ib , the maximum tolerated dose of E+P was defined as eribulin 0.9 mg/m ( 2 ) with pemetrexed ( 500mg/m ( 2 ) ) each on day 1 of a 21-day cycle .


In phase II , adverse events were comparable between groups .


PFS and OSwere similar between treatment groups .


Median PFS was 21.4 weeks for E+P ( n = 26 ; 95 % confidence interval [ CI ] , 12.7-39 .6 ) and 23.4 weeks for P ( n = 29 ; 95 % CI , 17.1-29 .9 ) , with a hazard ratio of 1.0 ( 95 % CI , 0.6-1 .7 ) .


During phase Ib , E+P was tolerated only at a markedly lower dosing intensity relative to the eribulin monotherapy regimen approved for breast cancer and used in phase II studies of NSCLC .


At the selected phase II dosing regimen , E+P was generally safe and well tolerated but provided no therapeutic advantage for the second-line treatment of locally advanced or metastatic nonsquamous NSCLC .


To assess the effectiveness of application of health locus of control in pregnant women for prevention of postpartum depression in Iran .


Nearly 10-15 % of women suffer postnatal depression by the end of the second week after delivery , which creates problems in caring for the child that may affect child 's future learning and concentration .


Pre-post experimental design .


Two hundred and thirty volunteer women were randomly divided into experimental and control groups .


The data collection tools included a demographic questionnaire , the Multidimensional Health Locus of Control Scale and the Edinburg Depression Scale .


Based on the associations found in the pretest , intervention programme was planned and carried out in the focused group discussion method .


Data were collected after the end of scheduled sessions , immediately and one month later .


The data were analysed with SPSS-16 using statistical methods including anova , chi-square test , Student 's t-test and paired t-test .


Chance health locus of control significantly reduced and internal health locus of control significantly increased , immediately after intervention .


Also , a month after intervention , a significant difference was observed between the two groups in reducing postpartum depression .


The planned participatory intervention led to empowerment and increased awareness and internalisation of health control beliefs and less tendency towards external health control beliefs , especially chance , improvement in general health leading to improved psychological health for prevention of postpartum depression in mothers .


Clinicians might assess chance and internal health locus of control to identify the women at risk of developing depression during their pregnancy and to develop prevention and treatment plans .


To examine adherence to , satisfaction with , and preliminary efficacy of mobile phone short message service ( SMS ) to promote health behaviors in school-aged children .


A total of 49 children ( aged 8-10 years ) were randomized by school classes into a monitoring vs no-monitoring group .


All children participated in 2 educational group sessions that focused on health behaviors : the advantages of increasing fruit and vegetable consumption and physical activity , and decreasing screen time .


The monitoring group also reported daily behavior using SMS and received supportive feedback for 8 weeks .


Children submitted 61 % of the required SMS , which indicated good adherence to the intervention .


A number of children ( 95 % ) reported being satisfied with the program .


Analyses of covariance indicated increase in fruit and vegetable consumption ( [ 2 ] = 7.27 ; P < .05 ) and a decrease in screen time ( [ 2 ] = 6.79 ; P < .05 ) .


The current SMS intervention was a useful tool to monitor and promote health behaviors in children .


Thrombosis has been associated to some diseases like hyperadrenocorticism ( HAC ) .


Several drugs can alter the balance , such as the corticosteroid prednisone , used mainly for its anti-inflammatory and immunosuppressive effects .


It is known that hypercortisolism can stimulate thrombi formation by increasing coagulation factors and decreasing fibrinolysis .


However it is not known how prednisone administration affects hemostasis in dogs and if it is dose dependent .


The aim of this study , therefore , was to demonstrate the effects of prednisone administration on dogs ' hemostatic profile .


Significant decrease of antithrombin levels was observed in both groups ( anti-inflammatory and immunosuppressive doses ) after 15days of treatment .


An increase of platelet aggregation was observed in dogs receiving immunosuppressive doses of prednisone ( Group II ) .


From the results obtained in our study , it is not possible to infer that hypercortisolism can increase the thromboembolic risk , despite the decreased anticoagulant factors ( antithrombin levels ) .


The optimal approach to estrogen replacement in girls with Turner syndrome has not been determined .


The aim of the study was to assess the effects of an individualized regimen of low-dose ethinyl estradiol ( EE2 ) during childhood from as early as age 5 , followed by a pubertal induction regimen starting after age 12 and escalating to full replacement over 4 years .


This study was a prospective , randomized , double-blind , placebo-controlled clinical trial .


The study was conducted at two US pediatric endocrine centers .


Girls with Turner syndrome ( n = 149 ) , aged 5.0-12 .5 years , were enrolled ; data from 123 girls were analyzable for pubertal onset .


Interventions comprised placebo or recombinant GH injections three times a week , with daily oral placebo or oral EE2 during childhood ( 25 ng/kg/d , ages 5-8 y ; 50 ng/kg/d , ages > 8-12 y ) ; after age 12 , all patients received escalating EE2 starting at a nominal dosage of 100 ng/kg/d .


Placebo/EE2 dosages were reduced by 50 % for breast development before age 12 years , vaginal bleeding before age 14 years , or undue advance in bone age .


The main outcome measures for this report were median ages at Tanner breast stage 2 , median age at menarche , and tempo of puberty ( Tanner 2 to menarche ) .


Patterns of gonadotropin secretion and impact of childhood EE2 on gonadotropins also were assessed .


Compared with recipients of oral placebo ( n = 62 ) , girls who received childhood low-dose EE2 ( n = 61 ) had significantly earlier thelarche ( median , 11.6 vs 12.6 y , P < 0.001 ) and slower tempo of puberty ( median , 3.3 vs 2.2 y , P = 0.003 ) ; both groups had delayed menarche ( median , 15.0 y ) .


Among childhood placebo recipients , girls who had spontaneous breast development before estrogen exposure had significantly lower median FSH values than girls who did not .


In addition to previously reported effects on cognitive measures and GH-mediated height gain , childhood estrogen replacement significantly normalized the onset and tempo of puberty .


Childhood low-dose estrogen replacement should be considered for girls with Turner syndrome .


In asthma and other diseases , vitamin D insufficiency is associated with adverse outcomes .


It is not known if supplementing inhaled corticosteroids with oral vitamin D3 improves outcomes in patients with asthma and vitamin D insufficiency .


To evaluate if vitamin D supplementation would improve the clinical efficacy of inhaled corticosteroids in patients with symptomatic asthma and lower vitamin D levels .


The VIDA ( Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma ) randomized , double-blind , parallel , placebo-controlled trial studying adult patients with symptomatic asthma and a serum 25-hydroxyvitamin D level of less than 30 ng/mL was conducted across 9 academic US medical centers in the National Heart , Lung , and Blood Institute 's AsthmaNet network , with enrollment starting in April 2011 and follow-up complete by January 2014 .


After a run-in period that included treatment with an inhaled corticosteroid , 408 patients were randomized .


Oral vitamin D3 ( 100,000 IU once , then 4000 IU/d for 28 weeks ; n = 201 ) or placebo ( n = 207 ) was added to inhaled ciclesonide ( 320 g/d ) .


If asthma control was achieved after 12 weeks , ciclesonide was tapered to 160 g/d for 8 weeks , then to 80 g/d for 8 weeks if asthma control was maintained .


The primary outcome was time to first asthma treatment failure ( a composite outcome of decline in lung function and increases in use of - agonists , systemic corticosteroids , and health care ) .


Treatment with vitamin D3 did not alter the rate of first treatment failure during 28 weeks ( 28 % [ 95 % CI , 21 % -34 % ] with vitamin D3 vs 29 % [ 95 % CI , 23 % -35 % ] with placebo ; adjusted hazard ratio , 0.9 [ 95 % CI , 0.6-1 .3 ] ) .


Of 14 prespecified secondary outcomes , 9 were analyzed , including asthma exacerbation ; of those 9 , the only statistically significant outcome was a small difference in the overall dose of ciclesonide required to maintain asthma control ( 111.3 g/d [ 95 % CI , 102.2-120 .4 g/d ] in the vitamin D3 group vs 126.2 g/d [ 95 % CI , 117.2-135 .3 g/d ] in the placebo group ; difference of 14.9 g/d [ 95 % CI , 2.1-27 .7 g/d ] ) .


Vitamin D3 did not reduce the rate of first treatment failure or exacerbation in adults with persistent asthma and vitamin D insufficiency .


These findings do not support a strategy of therapeutic vitamin D3 supplementation in patients with symptomatic asthma .


clinicaltrials.gov Identifier : NCT01248065 .


Term small-for-gestational-age and preterm born infants have an increased prevalence of metabolic syndrome components already in childhood .


Data in very-low-birth-weight ( VLBW ) children are limited .


We investigated the prevalence of metabolic syndrome components in VLBW infants at 2 years of corrected age .


We included 38 children , participating in the Neonatal Insulin Replacement Therapy in Europe ( NIRTURE ) trial , a randomized controlled trial of early insulin therapy in VLBW infants .


Metabolic syndrome components were defined as : body mass index SDS > 2 ; blood pressure ( systolic and/or diastolic ) 90th percentile ; triglycerides 0.98 mmol/l ; high-density lipoprotein ( HDL ) cholesterol 1.03 mmol/l ; glucose 5.6 mmol/l .


Two children ( 5 % ) had three metabolic syndrome components , 13 children ( 34 % ) had two components , and 11 children ( 29 % ) one component .


63 % had raised blood pressure ( prevalence higher in boys ) , 32 % low HDL , and 30 % high triglycerides ( prevalence lower in early insulin group ) .


In children with body mass index SDS < 0 , insulin-treated children had higher HDL than children with standard care .


Systolic blood pressure was correlated with growth between term and 2 years of corrected age .


VLBW infants already have a high prevalence of metabolic syndrome components at 2 years of corrected age .


Early insulin treatment could have long-term benefits for some of these components .


Hyperpigmentation is a common concern and has many causes including lentigines and melasma .


Currently available topical products for hyperpigmentation are limited by their potential for irritation , lack of demonstrated efficacy or regulatory concerns .


To compare the efficacy of a new skin lightening product with and without iontophoresis to a known effective product ( tretinoin ) and placebo on hyperpigmentation caused by lentigines and/or melasma .


Secondary objectives included an assessment of the product 's effects on the appearance of rhytides and roughness .


Eighty subjects were randomized into one of four treatment groups : proprietary lightening product , proprietary lightening product with iontophoresis , tretinoin 0.05 % cream , or vehicle control .


Seventy-four subjects completed all study visits .


Blinded assessments of subjects were performed at each visit under ambient and Wood 's light .


The proprietary skin lightening product improved facial hyperpigmentation versus placebo under ambient light ( P = 0.05 ) and Wood 's lamp ( P = 0.01 ) examination .


Tretinoin also improved facial hyperpigmentation versus placebo under Wood 's lamp ( P = 0.01 ) .


The proprietary product was better tolerated than tretinoin , with fewer subject reported side effects .


The investigational product was effective and may be better tolerated than tretinoin cream .


Pain is a troublesome non-motor symptom of Parkinson 's disease ( PD ) .


The RECOVER ( Randomized Evaluation of the 24-hour Coverage : Efficacy of Rotigotine ; Clintrials.gov : NCT00474058 ) study demonstrated significant improvements in early-morning motor function ( UPDRS III ) and sleep disturbances ( PDSS-2 ) with rotigotine transdermal system .


Improvements were also reported on a Likert pain scale ( measuring any type of pain ) .


This post hoc analysis of RECOVER further evaluates the effect of rotigotine on pain , and whether improvements in pain may be attributable to benefits in motor function or sleep disturbance .


PD patients with unsatisfactory early-morning motor impairment were randomized to optimal-dose ( up to 16 mg/24 h ) rotigotine or placebo , maintained for 4 weeks .


Pain was assessed in the early-morning using an 11-point Likert pain scale ( rated average severity of pain ( of any type ) over the preceding 12 hours from 0 [ no pain ] to 10 [ worst pain ever experienced ] ) .


Post hoc analyses for patients reporting ` any ' pain ( pain score 1 ) at baseline , and subgroups reporting ` mild ' ( score 1-3 ) , and ` moderate-to-severe ' pain ( score 4 ) were performed .


Likert pain scale change from baseline in rotigotine-treated patients was further analyzed based on a UPDRS III/PDSS -2 responder analysis ( a responder defined as showing a 30 % reduction in early morning UPDRS III total score or PDSS-2 total score ) .


As post hoc analyses , all p values presented are exploratory .


Of 267 patients with Likert pain data ( 178 rotigotine , 89 placebo ) , 187 ( 70 % ) reported ` any ' pain ; of these 87 ( 33 % ) reported ` mild ' , and 100 ( 37 % ) ` moderate-to-severe ' pain .


Change from baseline pain scores decreased with rotigotine compared with placebo in patients with ` any ' pain ( -0.88 [ 95 % CI : -1.56 , -0.19 ] , p = 0.013 ) , and in the subgroup with ` moderate-to-severe ' pain ( -1.38 [ -2.44 , -0.31 ] , p = 0.012 ) .


UPDRS III or PDSS-2 responders showed greater improvement in pain than non-responders .


The results from this post hoc analysis of the RECOVER study suggest that pain was improved in patients with PD treated with rotigotine ; this may be partly attributable to benefits in motor function and sleep disturbances .


Prospective studies are warranted to investigate this potential benefit and the clinical relevance of these findings .


The aim of the study was to determine if a high salt meal containing 65 mmol Na causes a rise in sodium concentrations and a reduction in plasma nitrate/nitrite concentrations ( an index of nitric oxide production ) .


Secondary aims were to determine the effects of a high salt meal on augmentation index ( AIx ) a measure of arterial stiffness and markers of endothelial function .


In a randomised cross-over study 16 healthy normotensive adults consumed a low sodium soup containing 5 mmol Na and a high sodium soup containing 65 mmol Na .


Sodium , plasma nitrate/nitrite , endothelin-1 ( ET-1 ) , C-reactive protein ( CRP ) , vasopressin ( AVP ) and atrial natriuretic peptide ( ANP ) concentrations before and every 30 min after the soup for 2 h. Blood pressure ( BP ) and AI were also measured at these time points .


There were significant increases in serum sodium , osmolality and chloride in response to the high sodium meal .


However plasma nitrate/nitrite concentrations were not different between meals ( meal p = 0.812 ; time p = 0.45 ; meal time interaction p = 0.50 ) .


Plasma ANP , AVP and ET-1 were not different between meals .


AI was significantly increased following the high sodium meal ( p = 0.02 ) but there was no effect on BP .


A meal containing 65 mmol Na increases serum sodium and arterial stiffness but does not alter postprandial nitrate/nitrite concentration in healthy normotensive individuals .


Further research is needed to explore the mechanism by which salt affects vascular function in the postprandial period .


This trial was registered with the Australian and New Zealand Clinical Trials Registry Unique Identifier : ACTRN12611000583943http : / / www.anzctr.org.au/trial_view.aspx?ID=343019 .


Many observational studies linked vitamin D to cardiometabolic risks besides its pivotal role in musculoskeletal diseases , but evidence from trials is lacking and inconsistent .


To determine whether Vitamin D supplementation in urban premenopausal women with vitamin D deficiency can improve cardiometabolic risks and health-related quality of life ( HRQOL ) .


A double-blind randomized controlled trial was conducted in Kuala Lumpur , Malaysia .


A total of 192 vitamin D deficient ( < 50 nmol/l ) premenopausal women were randomized to receive either vitamin D 50,000 IU or placebo once a week for 2 months and then monthly for 10 months .


Primary outcomes were serum 25 ( OH ) D , serum lipid profiles , blood pressure and HOMA-IR measured at baseline , 6 months and 12 months .


HRQOL was assessed with SF-36 at baseline and 12 months .


Ninety three and ninety-nine women were randomised into intervention and placebo groups respectively .


After 12 months , there were significant differences in the serum 25 ( OH ) D concentration ( mean difference : 49.54 ; 95 % CI : 43.94 to 55.14 ) nmol/l ) and PTH levels ( mean difference : -1.02 ; 95 % CI : -1.67 to -0.38 pmol/l ) in the intervention group compared to placebo group .


There was significant difference between treatment group in both serum 25 ( OH ) D and PTH .


There was no effect of supplementation on HOMA-IR , serum lipid profiles and blood pressure ( all p > 0.05 ) between two groups .


There was a small but significant improvement in HRQOL in the components of vitality ( mean difference : 5.041 ; 95 % CI : 0.709 to 9.374 ) and mental component score ( mean difference : 2.951 ; 95 % CI : 0.573 to 5.329 ) in the intervention group compared to placebo group .


Large and less frequent dosage vitamin D supplementation was safe and effective in the achievement of vitamin D sufficiency .


However , there was no improvement in measured cardiometabolic risk factors in premenopausal women .


Conversely vitamin D supplementation improves some components of HRQOL .


Australian New Zealand Clinical Trial Registry ACTRN12612000452897 .


A hip fracture causes bleeding , pain and immobility , and initiates inflammatory , hypercoagulable , catabolic and stress states .


Accelerated surgery may improve outcomes by reducing the duration of these states and immobility .


We undertook a pilot trial to determine the feasibility of a trial comparing accelerated care ( i.e. , rapid medical clearance and surgery ) and standard care among patients with a hip fracture .


Patients aged 45 years or older who , during weekday , daytime working hours , received a diagnosis of a hip fracture requiring surgery were randomly assigned to receive accelerated or standard care .


Our feasibility outcomes included the proportion of eligible patients randomly assigned , completeness of follow-up and timelines of accelerated surgery .


The main clinical outcome , assessed by data collectors and adjudicators who were unaware of study group allocations , was a major perioperative complication ( i.e. , a composite of death , preoperative myocardial infarction , myocardial injury after noncardiac surgery , pulmonary embolism , pneumonia , stroke , and life-threatening or major bleeding ) within 30 days of randomization .


Of patients eligible for inclusion , 80 % consented and were randomly assigned to groups ( 30 to accelerated care and 30 to standard care ) at 2 centres in Canada and 1 centre in India .


All patients completed 30-day follow-up .


The median time from diagnosis to surgery was 6.0 hours in the accelerated care group and 24.2 hours in the standard care group ( p < 0.001 ) .


A major perioperative complication occurred in 9 ( 30 % ) of the patients in the accelerated care group and 14 ( 47 % ) of the patients in the standard care group ( hazard ratio 0.60 , 95 % confidence interval 0.26-1 .39 ) .


These results show the feasibility of a trial comparing accelerated and standard care among patients with hip fracture and support a definitive trial .


ClinicalTrials.gov , no .


NCT01344343 .


To describe an intervention promoting benefit-finding in Alzheimer caregivers , to discuss key issues in implementation and ways to resolve them , and to examine whether the intervention reduced burden and depression in a small randomized trial .


Twenty-five caregivers were randomized into benefit-finding and psychoeducation groups .


Both groups had eight weekly sessions .


Outcome measures including role overload , Zarit Burden Interview , and Hamilton depression scale were collected at baseline and after treatment .


Results were analyzed using analysis of covariance .


Additionally , the challenges of implementing such interventions , some of which related to cultural issues , were analyzed qualitatively .


Controlling for pretest , the benefit-finding group had lower depression than the psychoeducation group at post-test , despite the fact that some caregivers found benefit-finding challenging .


The two groups did not differ on overload and burden .


However , within-group analysis suggested that both groups showed significant reductions in overload from pretest to post-test .


In addition , we discussed participants ' difficulties in grasping the technique of thought modification for benefit-finding , recording such exercises at home , and sharing their thoughts and experiences in groups .


We described measures undertaken in the main trial to overcome these issues .


Cognitive approaches focusing on benefit-finding are feasible among Chinese caregivers , with preliminary evidence suggesting an effect on alleviating depression .


Implantation failure represents a major cause of stress to both clinician and patient undergoing ICSI cycle .


Even minor uterine cavity abnormalities , such as endometrial polyps , small submucous myomas , adhesions , and septa are considered to have a negative impact on the chance to conceive through ICSI .


This study aimed at assessing the role of using the office hysteroscopy as a routine investigation in improving ICSI pregnancy rates .


ICSI was performed in two groups of infertile women with no abnormality detected in transvaginal ultrasonographic examination , group I : n = 97 and group II : n = 96 , women in group I were subjected to hysteroscopic examination before ICSI while group II underwent ICSI without hysteroscopy .


Then , ICSI was performed for all subjects of the two study groups with no statistically significant difference ( p > 0.05 ) regarding the number of oocytes retrieved and the number of embryo transfer .


Then , all subjects were followed up for 3 weeks after embryo transfer for detection of pregnancy by ultrasound .


43.3 % of group I showed abnormal hysteroscopic findings .


Group I showed a significantly higher pregnancy rate ( 70.1 % ) than that of group II ( 45.8 % ) ( p = 0.001 ) .


There is statistically significant association between the use of hysteroscopy prior to ICSI and the rate of pregnancy ( OR 2.77 , 95 % CI [ 1.53-5 .00 ] ) .


In addition , hysteroscopy had detected abnormalities in near half of cases whose ultrasound was normal .


Routine office hysteroscopy is an essential step for infertility workup before ICSI even in patients with normal TV/US .


The symptoms with optic ataxia suggest that simple and visually guided hand movements are controlled by 2 different neural substrates .


To assess the differential frequency-coded posterior parietal cortex ( PPC ) role in planning visuo-motor goal-directed tasks , we studied the action specificity of event-related desynchronization ( ERD ) in this area .


We investigated cortical activity by electroencephalography , while 16 healthy subjects performed self-paced reaching or wrist extension ( control ) movements .


Time-frequency representations were calculated for each movement during the preparatory period .


ERD dynamics in upper alpha-band indicated that preparing a goal-directed action activates contralateral PPC to the moving hand around 1.2 s before starting the movement , while this activation is later ( around 0.7 s ) in preparing a not-goal-directed action .


The posterior dominant rhythm had peak frequency of lower alpha-band at bilateral parietal .


Posterior parietal cortex encodes goal-directed movement preparation through upper alpha-band activity , whereas general attention is processed via lower alpha-band oscillations .


Preparing to reach an object engages posterior parietal cortex earlier than a not-goal directed movement .


To evaluate the efficacy of a power toothbrush with distinct multi-directional cleaning action using two different heads ( Colgate ProClinical C200 toothbrush with either a triple clean head or a sensitive head ) as compared to a manual flat-trim toothbrush ( Oral B Indicator toothbrush ) on supragingival plaque and established gingivitis .


This examiner-blind , randomized , controlled , three-treatment , parallel-group clinical research study assessed plaque removal via the comparison of pre - to post-brushing after a single use and again after four weeks of use , using the Rustogi Modified Navy Plaque Index .


This study also assessed gingivitis at four weeks using the Le-Silness Gingival Index .


Qualifying adult male and female subjects from the central New Jersey , USA area reported to the study site after refraining from any oral hygiene procedures for 24 hours , and from eating , drinking , and smoking for four hours .


Following an examination for plaque and gingivitis , they were randomized into three balanced groups .


Subjects were instructed to brush their teeth for two minutes under supervision with their assigned toothbrush and a commercially available toothpaste ( Colgate Cavity Protection toothpaste ) , after which they were again evaluated for plaque .


Subjects were dismissed from the study site with the toothpaste and their assigned toothbrush to use at home twice daily for the next four weeks .


They reported to the study site after four weeks of product use , at which time they were evaluated for plaque and gingivitis .


One hundred twenty ( 120 ) enrolled subjects complied with the protocol and completed the clinical study .


The results of the study indicated that all three test products provided statistically significant reductions in pre-brushing to post-brushing plaque scores for whole mouth and interproximal sites after a single use .


For gingival margin plaque sites , only the Colgate ProClinical C200 toothbrush , with either the triple clean head or the sensitive head , provided statistically significant reductions in pre - to post-brushing plaque scores .


After four weeks of product use , all three test products provided statistically significant reductions in baseline to four-week whole mouth and interproximal site plaque scores , but only the Colgate ProClinical C200 toothbrush , with either the triple clean head or the sensitive head , provided a statistically significant reduction in plaque scores at gingival margin sites .


All three test products provided statistically significant reductions in gingival and gingivitis severity index scores after four weeks of product use .


Relative to the manual toothbrush group , after a single tooth brushing the Colgate ProClinical C200 toothbrush , with either the triple clean head or sensitive head , provided statistically significantly greater reductions in whole mouth plaque index scores ( 51.9 % and 59.3 % , respectively ) , in gingival margin plaque index scores ( 700 % and 650 % , respectively ) , and interproximal plaque index scores ( 64.2 % and 60.4 % , respectively ) .


Relative to the manual toothbrush group , after four weeks of use the Colgate ProClinical C200 toothbrush , with either the triple clean head or sensitive head , provided statistically significantly greater reductions in whole mouth plaque index scores ( 78.6 % , and 82.1 % , respectively ) , in gingival margin plaque index scores ( 3700 % and 3400 % , respectively ) , and interproximal plaque index scores ( 50.8 % and 52.5 % , respectively ) .


Relative to the manual toothbrush group , after four weeks of use the Colgate ProClinical C200 toothbrush , with either the triple clean head or sensitive head , provided statistically significantly greater reductions in gingival index scores of 900 % and 833 % , respectively , and in gingivitis severity index scores of 466.7 % and 600 % , respectively .


All statistically significant reductions were at the p 0.05 level .


There were no statistically significant differences between the scores of the Colgate ProClinical C200 toothbrush with triple clean head and the scores of the Colgate ProClinical C200 toothbrush with sensitive head at any comparison time point .


The Colgate ProClinicaI C200 toothbrush , with either a triple clean head or a sensitive head , provides statistically significant and clinically relevant levels of efficacy in the removal of supragingival dental plaque in the whole mouth , at the gingival margin , and interproximally after a single tooth brushing and after four weeks of use , as well as a statistically significantly greater level of efficacy in the reduction of gingivitis and gingival bleeding when compared to a manual flat-trim toothbrush .


We compared the effect of 3 animal protein sources on urinary stone risk .


A total of 15 healthy subjects completed a 3-phase randomized , crossover metabolic study .


During each 1-week phase subjects consumed a standard metabolic diet containing beef , chicken or fish .


Serum chemistry and 24-hour urine samples collected at the end of each phase were compared using mixed model repeated measures analysis .


Serum and urinary uric acid were increased for each phase .


Beef was associated with lower serum uric acid than chicken or fish ( 6.5 vs 7.0 and 7.3 mg/dl , respectively , each p < 0.05 ) .


Fish was associated with higher urinary uric acid than beef or chicken ( 741 vs 638 and 641 mg per day , p = 0.003 and 0.04 , respectively ) .


No significant difference among phases was noted in urinary pH , sulfate , calcium , citrate , oxalate or sodium .


Mean saturation index for calcium oxalate was highest for beef ( 2.48 ) , although the difference attained significance only compared to chicken ( 1.67 , p = 0.02 ) but not to fish ( 1.79 , p = 0.08 ) .


Consuming animal protein is associated with increased serum and urine uric acid in healthy individuals .


The higher purine content of fish compared to beef or chicken is reflected in higher 24-hour urinary uric acid .


However , as reflected in the saturation index , the stone forming propensity is marginally higher for beef compared to fish or chicken .


Stone formers should be advised to limit the intake of all animal proteins , including fish .


Pre-exposure prophylaxis ( PrEP ) trials using tenofovir-based regimens have demonstrated that high levels of adherence are required to evaluate efficacy ; the incorporation of objective biomarkers of adherence in trial design has been essential to interpretation , given the inaccuracy of self-report .


Antiretroviral measurements in scalp hair have been useful as a marker of long-term exposure in the HIV treatment setting , and hair samples are relatively easy and inexpensive to collect , transport , and store for analysis .


To evaluate the relationship between dose and tenofovir concentrations in hair , we examined the dose proportionality of tenofovir in hair in healthy , HIV-uninfected adults .


A phase I , crossover pharmacokinetic study was performed in 24 HIV-negative adults receiving directly-observed oral tenofovir tablets administered 2 , 4 , and 7 doses/week for 6 weeks , with a 3-week break between periods .


Small samples of hair were collected after each six-week period and analyzed for tenofovir concentrations .


Geometric-mean-ratios compared levels between each pair of dosing conditions .


Intensive plasma pharmacokinetic studies were performed during the daily-dosing period to calculate areas-under-the-time-concentration curves ( AUCs ) .


Over 90 % of doses were observed per protocol .


Median tenofovir concentrations in hair increased monotonically with dose .


A log-linear relationship was seen between dose and hair levels , with an estimated 76 % ( 95 % CI 60-93 % ) increase in hair level per 2-fold dose increase .


Tenofovir plasma AUCs modestly predicted drug concentrations in hair .


This study found a strong linear relationship between frequency of dosing and tenofovir levels in scalp hair .


The analysis of quantitative drug levels in hair has the potential to improve adherence measurement in the PrEP field and may be helpful in determining exposure thresholds for protection and explaining failures in PrEP trials .


Hair measures for adherence monitoring may also facilitate adherence measurement in real-world settings and merit further investigation in upcoming PrEP implementation studies and programs .


ClinicalTrials.gov NCT00903084 .


Talactoferrin alfa is a recombinant form of the human glycoprotein , lactoferrin , which has been shown to have a wide range of effects on the immune system .


This phase II/III clinical trial compared talactoferrin with placebo , in addition to standard of care , in patients with severe sepsis .


Multicenter , randomized , placebo-controlled , phase II/III clinical study .


Seventy-seven centers in 10 countries .


Adult ( > 18 yr ) patients admitted to one of the participating centers with severe sepsis who were receiving antimicrobial therapy and able to take liquid medication by mouth or feeding tube .


Patients were randomized to receive either talactoferrin ( 1.5 g , 15mL ) or placebo three times a day orally or by another enteral route for 28 days or until ICU discharge .


The study was terminated after 305 patients had been enrolled ( 153 talactoferrin and 152 placebo ) because of futility and safety concerns identified by the Data Safety Monitoring Board .


There were no significant differences between groups in baseline characteristics including age , sex , site of infection , and severity scores .


Twenty-eight-day mortality was higher in talactoferrin-treated patients although this difference was not statistically significant ( 24.8 % vs 17.8 % placebo ; p = 0.117 ) .


The difference was largely the result of differences in patients with shock ( talactoferrin , 33/105 [ 31.4 % ] vs placebo , 21/104 [ 20.2 % ] ; p = 0.064 ) ; no mortality difference was seen in patients without shock ( talactoferrin , 5/48 [ 10.4 % ] vs placebo , 6/48 [ 12.5 % ] ; p = 0.806 ) .


In-hospital ( 43/153 [ 28.1 % ] vs 27/152 [ 17.8 % ] ; p = 0.037 ) and 3-month ( 46/153 [ 30.1 % ] vs 31/152 [ 20.4 % ] ; p = 0.036 ) mortality rates were significantly higher in talactoferrin-treated patients than in patients in the placebo group .


The occurrence of treatment-related adverse or serious adverse events was similar between groups .


Administration of oral talactoferrin was not associated with reduced 28-day mortality in patients with severe sepsis and may even be harmful .


To evaluate the surgical effect of levator muscle shortening and levator aponeurosis tucking in treating minimal and moderate congenital blepharoptosis .


Clinical data of 28 patients ( 40 eyes ) diagnosed with mide and moderate congenital blepharoptosis at our institution were retrospectively analyzed .


Postoperative efficacy was evaluated and statistically compared between these two techniques .


During 14 months follow-up , 16 eyes with ptosis undergoing levator muscle shortening were treated , 3 with undercorrection of ptosis and 1 with overcorrection of ptosis .


In patients receiving levator aponeurosis tucking , 16 eyes were cured and 4 with undercorrection of ptosis .


Both levator muscle shortening and levator aponeurosis tucking are safe and efficacious for correcting minimal and moderate congenital blepharoptosis .


( Eye Science


Despite its high prevalence , help-seeking for depression is low .


To assess the effectiveness and cost-effectiveness of 1-day cognitive-behavioural therapy ( CBT ) self-confidence workshops in reducing depression .


Anxiety , self-esteem , prognostic indicators as well as access were also assessed .


An open randomised controlled trial ( RCT ) waiting list control design with 12-week follow-up was used ( trial registration : ISRCTN26634837 ) .


A total of 459 adult participants with depression ( Beck Depression Inventory ( BDI ) scores of 14 ) self-referred and 382 participants ( 83 % ) were followed up .


At follow-up , experimental and control participants differed significantly on the BDI , with an effect size of 0.55 .


Anxiety and self-esteem also differed .


Of those who participated , 25 % were GP non-consulters and 32 % were from Black and minority ethnic groups .


Women benefited more than men on depression scores .


The intervention has a 90 % chance of being considered cost-effective if a depression-free day is valued at 14 .


Self-confidence workshops appear promising in terms of clinical effectiveness , cost-effectiveness and access by difficult-to-engage groups .


Open reduction and internal plate fixation of the fibula is the gold standard treatment for ankle fractures .


The aim of this study was to perform a prospective randomized study to compare bone union , complications and functional results of two types of internal fixation of the fibula ( plating and the Epifisa FH intramedullary nail ) .


Inclusion criteria were : closed fractures , isolated displaced fractures of the lateral malleolus , inter - and supra-tubercular bimalleolar fractures , and trimalleolar fractures .


This study included 71 patients ( mean age 53 19 ) : plate fixation group ( n = 35 ) and intramedullary nail fixation group ( n = 36 ) .


In seven cases , intramedullary nailing was technically impossible and was converted to plate fixation ( the analysis of this sub-group was performed independently ) .


Two patients died and two patients were lost to follow-up .


The final comparative series included 32 cases of plate fixation and 28 cases of intramedullary nail fixation .


Union , postoperative complications and Kitaoka and Olerud-Molander functional scores were analyzed after one year of follow-up .


There was no significant difference in the rate of union ( P = 0.5605 ) between the two types of fixation .


There were significantly fewer complications ( 7 % versus 56 % ) and better functional scores ( 96 versus 82 for the Kitaoka score ; 97 versus 83 for the Olerud-Molander score ) with intramedullary nailing than with plate fixation .


Intramedullary nailing of the lateral malleolus in non-comminuted ankle fractures without syndesmotic injury is a reproducible technique with very few complications that provides better functional results than plate fixation .


II ( randomized prospective study ) .


Research suggests that quantitative information in direct-to-consumer ( DTC ) prescription drug ads may be helpful for consumers .


The objective was to examine the effect of adding placebo rates and framing to DTC ads .


In study 1 , 2,000 Internet panel members with chronic pain participated in a randomized controlled experiment of DTC ads varying in placebo rate and framing .


In study 2 , 596 physicians ranked DTC ads varying in placebo rate and framing by how well they conveyed scientific information and their usefulness for patients .


In study 1 , participants who viewed placebo rates were able to recall them and use them to form certain perceptions .


A mixed frame led to lower placebo rate recall and perceived efficacy .


In study 2 , overall , physicians preferred a placebo/single frame ad .


Adding placebo rates to DTC ads may be useful for consumers .


The evidence does not support using a mixed frame .


To investigate adjuvant effect and safety of intratympanic steroid for the treatment of Bell 's palsy .


Prospective , investigator blinded , randomized study .


Tertiary referral center .


Patients who received treatment for Bell 's palsy from December 2007 to March 2011 were randomly divided into two groups .


The control group ( n = 17 ) was treated with systemic steroid plus antiviral agent , and intratympanic steroid injection group ( IT group , n = 14 ) received intratympanic steroid injection combined with medications .


Facial functions were evaluated on a regular basis up to 6 months .


Intratympanic steroid injection .


Facial nerve functions of initial presentation and follow-up were evaluated with House-Brackmann ( H-B ) system .


Primary outcome was complete recovery rate of 6 months .


Secondary outcomes included improvement of H-B grade within 3 weeks , time of first improvement in facial function , and cumulative recovery rate .


In addition , subgroup analysis of H-B grade over than IV was performed .


Complete recovery rate was not different between groups .


Time of first improvement was shorter in IT group ( p = 0.043 ) .


And IT group had a better cumulative recovery rate ( p = 0.041 ) and showed the significant improvement in H-B grade within 3 weeks compared with control group ( p = 0.045 ) .


In severe facial palsy , complete recovery rate of IT group and control group were 80 % and 50 % ( p = 0.16 ) , and IT groups showed the significant facial improvement within 3 weeks ( p = 0.025 ) .


And there were no major adverse effects of intratympanic injection .


Intratympanic steroid injection might be a safe and useful adjuvant treatment modality for Bell 's palsy .


The hypothesis was that a reminder about recommended primary care physician ( PCP ) follow-up , sent via e-mail to patients discharged from the emergency department ( ED ) , would increase the proportion of patients who followed up with their PCPs within the recommended time frame .


Patient receptiveness to e-mail follow-up reminders was also assessed .


This was a mixed methods clinical intervention study with subjects randomized either to receive the usual care discharge instructions only or to also receive a reminder e-mail message the day after the ED visit .


The reminder e-mail contained the subject 's PCP 's name and address and the recommended PCP follow-up time interval .


A blinded review of outpatient PCP medical records was conducted to determine whether and when follow-up occurred .


Researchers attempted to contact patients with a telephone survey 2 weeks after their ED visits .


The primary outcomes between groups were compared using chi-square tests and relative risks ( RRs ) with 95 % confidence intervals ( CIs ) .


Thirty-three percent of the intervention group and 32 % of the control group followed-up as recommended ( RR = 1.04 , 95 % CI = 0.81 to 1.33 ) ; 52 % of the intervention group and 48 % of the control group followed-up within 10 days of the recommended time ( RR = 1.08 , 95 % CI = 0.91 to 1.29 ) .


The 334 patients ( 57 % ) successfully contacted via telephone demonstrated a high interest in receiving future e-mail reminders ( 75 % ) , with the group that received e-mail reminders more likely to want one in the future than those who did not receive e-mail reminders ( 82.5 % vs. 69.76 % ; p = 0.04 ) .


E-mail reminders sent after ED visits did not improve patients ' adherence to the recommended timing of primary care follow-up contained in discharge instructions .


Subjects in both the control and the intervention groups favorably viewed the concept of e-mail reminders , suggesting that the value of e-mail reminders after ED discharge may be in areas such as patient satisfaction that were not specifically targeted for measurement in this study .


The aim of this open , observational registry was to evaluate the effects of antithrombotic treatment on the development of postthrombotic syndrome ( PTS ) : the effects of `` standard management '' ( SM ; according to International Union of Angiology guidelines ) were compared to SM in association with sulodexide or aspirin .


Postthrombotic syndrome occurrence was observed in 3 nonparallel groups after deep venous thrombosis ( DVT ) ; the registry started after the end of the anticoagulation period .


The target was to observe the occurrence of PTS in 5 years .


Three possible options were suggested to the patients , and the patients and their caregivers defined the type of management .


A group of 167 patients was involved in the SM with reevaluation every 6 months ; the sulodexide group included 124 patients and the aspirin group included 48 patients .


The 3 groups were clinically similar and comparable for age and sex distribution .


Of the 167 patients in the SM group , 154 patients completed 60 months of follow-up .


The percentage of patients with PTS in the SM group ranged from 14.9 % ( 1 year after the end of anticoagulation ) to 19.5 % ( 60 months ) .


In the nonparallel group using sulodexide ( 124 comparable patients at inclusion ; 115 at 60 months ) , the percentage of PTS was variable from 8.8 % ( 1 year after anticoagulants ) to 12.17 % at 60 months .


These percentages are significantly lower than those observed with SM .


In the nonparallel aspirin group ( 48 patients at inclusion and 34 at 54 months ) , there was a PTS incidence of 23.5 % at 54 months ( vs 12.17 % in the sulodexide group and 18.23 % in the SM group ) .


The incidence of PTS was significantly higher in comparison with the other 2 groups .


The incidence of PTS was lower in the sulodexide group in comparison with the 2 other groups .


Sulodexide administration after DVT appears to be effective in preventing PTS in association with recommended management and a number of recurrent DVTs .


Modalities of treatment , dosages , and timing of administration should be explored in more comprehensive and complete studies .


Home-based interventions for heart failure ( HF ) patients might be particularly effective in middle-income countries , where social , cultural , and economic constraints limit the effectiveness of HF treatment outside the hospital environment .


HELEN-II was a randomized clinical trial conducted in Brazil designed to evaluate the clinical efficacy of a nurse-based strategy , started after discharge following an acute decompensated HF ( ADHF ) admission .


HELEN-II compares the efficacy of home visits and telephone reinforcement ( n = 123 ) with that of the conventional strategy , which is based on medical follow-up ( n = 129 ) .


The primary outcome was a composite endpoint of a first visit to the emergency department ( 24 h ) , a hospital readmission ( > 24 h ) , or all-cause death , assessed during the first 6 months of follow-up .


Most enrolled subjects were middle-aged ( 62 13 years ) males ( 63 % ) in NYHA functional class II-III ( 84 % ) with severe LV dysfunction ( mean LVEF 29.6 9 % ) .


The primary composite endpoint was decreased by 27 % in the interventional group ( relative risk 0.73 ; 95 % confidence interval 0.54-0 .99 ; P = 0.049 ) .


At the end of follow-up , the rate of use of the standard-of-care HF medications was similar in both groups , except for the higher use of furosemide in the interventional group .


Also , HF knowledge and self-care were significantly increased in the interventional group .


A post-discharge , nurse-led management strategy significantly decreases the morbidity of ADHF patients in the public health system of a developing middle-income country .


The value of hyperbaric oxygen therapy ( HBOT ) in the treatment of diabetic ulcers is still under debate .


Available evidence suggests that HBOT may improve the healing of diabetic ulcers , but it comes from small trials with heterogeneous populations and interventions .


The DAMOCLES-trial will assess the ( cost - ) effectiveness of HBOT for ischemic diabetic ulcers in addition to standard of care .


In a multicenter randomized clinical trial , including 30 hospitals and all 10 HBOT centers in the Netherlands , we plan to enroll 275 patients with Types 1 or 2 diabetes , a Wagner 2 , 3 or 4 ulcer of the leg present for at least 4 weeks , and concomitant leg ischemia , defined as an ankle systolic blood pressure of < 70mmHg , a toe systolic blood pressure of < 50mmHg or a forefoot transcutaneous oxygen tension ( TcpO2 ) of < 40mmHg .


Eligible patients may be candidates for revascularization .


Patients will be randomly assigned to standard care with or without 40 HBOT-sessions .


Primary outcome measures are freedom from major amputation after 12 months and achievement of , and time to , complete wound healing .


Secondary endpoints include freedom from minor amputations , ulcer recurrence , TcpO2 , quality of life , and safety .


In addition , we will assess the cost-effectiveness of HBOT for this indication .


The DAMOCLES trial will be the largest trial ever performed in the realm of HBOT for chronic ulcers , and it is unique for addressing patients with ischemic diabetic foot ulcers who may also receive vascular reconstructions .


This matches the treatment dilemma in current clinical practice .


To evaluate whether 5 5 mm dental implants with a novel nanostructured calciumincorporated titanium surface could be an alternative to implants at least 10 mm long placed in bone augmented with bone substitutes in posterior atrophic jaws .


A total of 40 patients with atrophic posterior ( premolar and molar areas ) mandibles having 5 to 7 mm of bone height above the mandibular canal and 40 patients with atrophic maxillae having 4 to 6 mm below the maxillary sinus , were randomised according to a parallel group design to receive one to three 5 mm implants or one to three at least 10 mm-long implants in augmented bone at two centres .


All implants had a diameter of 5 mm .


Mandibles were vertically augmented with interpositional bovine bone blocks and resorbable barriers .


Implants were placed after 4 months .


Maxillary sinuses were augmented with particulated porcine bone via a lateral window covered with resorbable barriers and implants were placed simultaneously .


All implants were submerged and loaded after 4 months with provisional prostheses .


Four months later , definitive screw-retained or provisionally cemented metal-ceramic or zirconia prostheses were delivered .


Patients were followed up to 1 year post-loading and the outcome measures were prosthesis and implant failures , any complications and peri-implant marginal bone level changes .


One maxillary grafted patient dropped out before the 1-year evaluation .


In mandibles , 1 grafted patient did not want to go ahead with the treatment because of multiple complications and graft failure , and another grafted patient did not receive his prostheses due the loss of 2 implants .


In maxillae , one 5 5 mm implant failed with its provisional crown 3 months post-loading .


There were no statistically significant differences in prostheses and implant failures .


Significantly more complications occurred at both mandibular and maxillary grafted sites : 17 augmented patients were affected by complications versus 8 patients treated with short implants in the mandible ( P = 0.0079 ; difference in proportion = -0.45 ; 95 % CI -0.67 to -0.15 ) , and 5 sinus-lift patients versus none treated with maxillary short implants ( P = 0.047 ; difference in proportion = -0.25 ; 95 % CI -0.44 to -0.06 ) .


Patients with mandibular short implants lost on average 0.94 mm of peri-implant bone at 1 year and patients with 10 mm or longer mandibular implants lost 1.03 mm .


Patients with maxillary short implants lost on average 0.87 mm of peri-implant bone at 1 year and patients with 10 mm or longer maxillary implants lost 1.15 mm .


There were no statistically significant differences in bone level changes up to 1 year between short and longer implants in maxillae ( mean difference -0.28 mm , 95 % CI -0.56 to 0.01 , P = 0.051 ) and in mandibles ( mean difference -0.09 mm , 95 % CI -0.26 to 0.08 , P = 0.295 ) .


One year after loading , 5 5 mm implants achieved similar results compared to longer implants placed in augmented bone .


Short implants might be a preferable choice to bone augmentation especially in posterior mandibles since the treatment is faster , cheaper and associated with less morbidity , however 5 to 10 years of post-loading data are necessary before making reliable recommendations .


MegaGen partially supported this trial and donated implants and prosthetic components used in this study , whereas Tecnoss donated the biomaterials .


The data belonged to the authors and by no means did the manufacturers interfere with the conduct of the trial or the publication of its results .


Long-duration beta-lactam antibiotics are used for empirical treatment in female dogs with uncomplicated bacterial cystitis .


However , women with bacterial cystitis are treated with short-duration potentiated sulfonamides because longer courses of beta-lactams result in lower cure and higher recurrence rates .


Short-duration potentiated sulfonamide treatment is more efficacious than long-duration beta-lactam treatment in achieving clinical and microbiological cures in female dogs with uncomplicated bacterial cystitis .


Thirty-eight client-owned female dogs .


Randomized , double-blinded , placebo-controlled clinical trial .


Dogs were treated with TMP-SMX ( 15 mg/kg PO q12h for 3 days followed by a placebo capsule PO q12h for 7 days ; Group SDS ; n = 20 ) or cephalexin ( 20 mg/kg PO q12h for 10 days ; Group LDBL ; n = 18 ) .


Dogs were monitored for clinical and microbiological cure during treatment and at short - and long-term follow-up .


No statistically significant differences were found between treatment groups in clinical cure rates after 3 days of treatment ( 89 % SDS , 94 % LDBL ; P = 1.00 ) and 4 days ( 85 % SDS , 72 % LDBL ; P = .44 ) or > 30 days ( 50 % SDS , 65 % LDBL ; P = .50 ) after conclusion of treatment or in microbiological cure rates 4 days ( 59 % SDS , 36 % LDBL ; P = .44 ) or > 30 days ( 44 % SDS , 20 % LDBL ; P = .40 ) after conclusion of treatment .


We did not identify a difference in cure rates between short-duration sulfonamide and long-duration beta-lactam treatments in female dogs with uncomplicated cystitis .


Long-term cure rates in both treatment groups were low .


In some female dogs , `` uncomplicated '' bacterial cystitis may be more complicated than previously recognized .


We evaluated the COX-2 inhibitors , etoricoxib and celecoxib , in Korean patients with osteoarthritis ( OA ) .


This study included patients ( 40 years of age ) with a clinical and radiographic diagnosis of knee OA .


Patients were randomized to etoricoxib 30 mg ( qd ) or celecoxib 200 mg ( qd ) in a 12 week randomized , controlled , double-blind study .


Prior NSAID users were to demonstrate a worsening of symptoms upon withdrawal of medication .


Efficacy endpoints included the time-weighted average change from baseline in the WOMAC VA 3.0 Pain Subscale ( 100 mm Visual Analog Scale [ VAS ] ; primary endpoint ) , the WOMAC VA 3.0 Physical Function Subscale ( 100 mm VAS ) , and Patient Global Assessment of Disease Status ( PGAD ) ( 100 mm VAS ) .


The primary hypothesis was that etoricoxib 30 mg is non-inferior to celecoxib 200 mg as assessed by the primary endpoint ( the non-inferiority margin was set at 10 mm VAS ) .


Adverse events ( AEs ) , laboratory parameters , and vital signs were monitored .


There were 239 patients ( 89.5 % female ; mean age : 63.3 years ) randomized to etoricoxib 30 mg ( n = 120 ) and celecoxib 200 mg ( n = 119 ) .


The differences ( etoricoxib vs celecoxib ) in least square ( LS ) mean change ( 95 % CI ) for WOMAC Pain , WOMAC Physical Function , and PGAD were -1.63 mm ( -5.37 , 2.10 ) , -1.32 mm ( -4.88 , 2.23 ) , and -1.09 mm ( -5.48 , 3.30 ) , respectively .


Drug-related clinical AEs occurred in 6.7 % ( etoricoxib ) and 2.5 % ( celecoxib ) of patients .


This study was limited because it was not designed or powered to adequately capture and evaluate rare AEs associated with NSAID treatment .


Etoricoxib 30 mg administered once daily in Korean patients with knee OA demonstrated non-inferior clinical efficacy to celecoxib 200 mg over 12 weeks of treatment as assessed by all primary and secondary outcomes .


Etoricoxib 30 mg qd and celecoxib 200 mg qd were generally safe and well tolerated .


NCT01554163 .


Although eye exercises appear to help heterophoria , convergence insufficiency , and intermittent strabismus , results can be confounded by placebo , practice , and encouragement effects .


This study assessed objective changes in vergence and accommodation responses in naive young adults after a 2-week period of eye exercises under controlled conditions to determine the extent to which treatment effects occur over other factors .


Asymptomatic young adults were randomly assigned to one of two no-treatment ( control ) groups or to one of six eye exercise groups : accommodation , vergence , both , convergence in excess of accommodation , accommodation in excess of convergence , and placebo .


Subjects were tested and retested under identical conditions , except for the second control group , who were additionally encouraged .


Objective accommodation and vergence were assessed to a range of targets moving in depth containing combinations of blur , disparity , and proximity/looming cues .


A total of 156 subjects were included .


Response gain improved more for less naturalistic targets where more improvement was possible .


Convergence exercises improved vergence for near across all targets ( P = 0.035 ) .


Mean accommodation changed similarly but nonsignificantly .