Age at cataract surgery was weakly associated with visual acuity ( Spearman rank correlation coefficient = 0.19 , P = 0.041 ) with median visual acuity better among the younger patients ( 28-48 days : 0.50 logMAR , 49-210 days : 1.10 logMAR , P = 0.046 ) .


Patients from families with private insurance had significantly better median visual acuity ( 0.60 vs. 1.40 logMAR , P = 0.0004 ) .


No other baseline characteristic revealed a significant bivariate relationship with visual acuity .


A multiple linear regression relating visual acuity to all baseline characteristics demonstrated that only the availability of private insurance was statistically significant , accounting for 12 % of the variance .


This analysis concurs with previous studies that early surgery is important for good visual outcomes in patients with unilateral infantile cataracts .


The fact that only one baseline variable ( private insurance ) contributed to the multivariate analysis , accounting for 12 % of the variance , suggests that predicting visual outcome for these patients is complicated at best , and can not be estimated from baseline characteristics alone .


( ClinicalTrials.gov number , NCT00212134 . )


To compare the efficacy and safety of bevacizumab versus ranibizumab when administered according to a treat-and-extend protocol for the treatment of neovascular age-related macular degeneration ( AMD ) .


Multicenter , randomized , noninferiority trial with a noninferiority limit of 5 letters .


Patients aged 50 years with previously untreated neovascular AMD in 1 eye and best-corrected visual acuity ( BCVA ) between 20/25 and 20/320 .


Patients were randomly assigned to receive ranibizumab 0.5 mg or bevacizumab 1.25 mg intravitreal injections .


Monthly injections were given until inactive disease was achieved .


The patients were then followed with a gradual extension of treatment interval by 2 weeks at a time up to a maximum of 12 weeks .


If signs of recurrent disease appeared , the treatment interval was shortened by 2 weeks at a time .


Change in visual acuity at 1 year .


Between March 2009 and July 2012 , 441 patients were randomized at 10 ophthalmological centers in Norway .


The 1-year visit was completed by 371 patients .


In the per protocol analysis at 1 year , bevacizumab was equivalent to ranibizumab , with 7.9 and 8.2 mean letters gained , respectively ( 95 % confidence interval [ CI ] of mean difference , -2.4 to 2.9 ; P = 0.845 ) .


The intention-to-treat analysis was concordant .


There was no significant difference in measured central retinal thickness ( CRT ) , with a mean decrease of -112 m for bevacizumab and -120 m for ranibizumab ( 95 % CI of mean difference , -13 to 28 ; P = 0.460 ) .


There was a statistically significant difference ( P = 0.001 ) between the drugs regarding the number of treatments : 8.9 for bevacizumab and 8.0 for ranibizumab .


There were fewer arteriothrombotic events in the bevacizumab group ( 1.4 % ) than in the ranibizumab group ( 4.5 % ) ( P = 0.050 ) and significantly more cardiac events in the ranibizumab group ( P = 0.036 ) .


However , patients treated with ranibizumab more often had a history of myocardial infarction ( P = 0.021 ) .


Bevacizumab and ranibizumab had equivalent effects on visual acuity at 1 year when administered according to a treat-and-extend protocol .


The visual acuity results at 1 year were comparable to those of other clinical trials with monthly treatment .


The numbers of serious adverse events were small .


To compare pressure ulcer healing rates in patients supplemented with a specialised amino acid mixture containing ( beta ) - hydroxy ( beta ) - methylbutyrate ( HMB ) , arginine and glutamine , and standard oral nutritional supplements versus patients supplemented with oral nutritional supplements and a placebo mixture .


Twenty-three inpatients with stage II , III or IV pressure ulcers in an acute care hospital were randomised to recieve ( A ) a HMB , arginine and glutamine mixture twice daily alongside oral nutritional supplements ( n = 11 ) or ( B ) standard nutritional care alongside oral nutritional supplements ( n = 12 ) for 2 weeks .


Pressure ulcers were measured weekly for area , depth and Pressure Ulcer Scale for Healing ( PUSH ) scores .


The proportion of viable tissue was determined based on area of wound tracing .


Weekly laboratory tests were performed to measure C-reactive protein and pre-albumin levels .


This trial is registered at http://ClinicalTrials.gov under NCT01090076 .


There was no difference between anthropometrical measurements , biochemical parameters and nutritional intake pre - and post - study .


Wound area did not decrease significantly in the short term for both groups .


The proportion of viable tissues increased within 2 weeks on HMB , arginine and glutamine supplementation ( p = 0.02 ) .


PUSH scores showed significant improvement within 1 week of supplementation for the experimental group ( p = 0.013 ) .


The use of specialised amino acid does not appear to reduce wound size and PUSH scores but may improve tissue viability after 2 weeks .


Further confirmation on a larger scale is required to determine the benefits of supplementing additional HMB , arginine and glutamine in patients with pressure ulcers .


Alcohol use disorder is one of the leading causes of disability worldwide .


While effective pharmacological treatments exist , they are efficacious only in certain individuals , contributing to their limited use .


Secondary analysis of clinical trial data suggests that a functional polymorphism ( rs1799971 , Asn40Asp ) of the - opioid receptor gene ( OPRM1 ) is associated with the risk of relapse to heavy drinking following treatment with the opioid antagonist naltrexone .


To prospectively examine whether rs1799971 is predictive of naltrexone treatment response .


We conducted a 12-week , double-blind , randomized clinical trial of naltrexone vs placebo in individuals with alcohol dependence ( intent-to-treat analysis ) .


Participants were randomly assigned to study treatment based on the presence of 1 or 2 copies of the Asp40 allele compared with those homozygous for the Asn40 allele ( 2 2 cell design ) .


Recruitment occurred between January 2009 and September 2013 .


All participants were seen in an outpatient clinical setting .


A convenience sample of participants ( n = 221 ) was recruited from 5 sites .


All participants met DSM-IV criteria for alcohol dependence , with no concurrent psychotic or manic symptoms , no use of concurrent psychotropic medications , and no current dependence on illicit substances .


The study drug was naltrexone ( 50 mg ) given once daily or corresponding placebo .


The primary study outcome measure was relapse to heavy drinking measured using the timeline follow-back method .


There was no evidence of a genotype treatment interaction on the primary outcome of heavy drinking ( P = .32 ) .


In the Asn40 group , the observed effect of naltrexone was similar to that in previous trials ( odds ratio , 0.69 ; 95 % CI , 0.41-1 .18 ; P = .17 ) , with a very small naltrexone effect in the Asp40 group ( odds ratio , 1.10 ; 95 % CI , 0.52-2 .31 ; P = .80 ) , contrary to the pattern expected a priori .


A significant reduction in heavy drinking occurred across all groups ( P = .001 ) .


Other drinking outcomes , and all secondary outcomes , demonstrated similar time effects , with no genotype treatment interaction .


The results of this study do not support the hypothesis that the Asp40 allele moderates the response to naltrexone treatment .


It is premature to use the Asn40Asp polymorphism as a biomarker to predict the response to naltrexone treatment of alcohol dependence .


clinicaltrials.gov Identifier : NCT00831272 .


YUKAWA is a 12-week , randomized , double-blind , placebo-controlled , phase 2 study evaluating the efficacy and safety of evolocumab ( AMG 145 ) in statin-treated Japanese patients at high cardiovascular risk .


310 eligible patients receiving stable statin ( ezetimibe ) therapy were randomized to 1 of 6 treatments : placebo every 2 weeks ( Q2W ) or monthly ( QM ) , evolocumab 70 mg or 140 mg Q2W , or evolocumab 280 mg or 420 mg QM .


The primary endpoint was the percentage change from baseline in low-density lipoprotein cholesterol ( LDL-C ) measured by preparative ultracentrifugation ( UC ) .


Secondary endpoints included percentage changes in other lipid parameters and the proportion of patients with LDL-C < 1.8 mmol/L .


Mean ( SD ) age was 62 ( 10 ) years ; 37 % were female ; and the mean ( SD ) baseline LDL-C was 3.7 ( 0.5 ) mmol/L ( by UC ) .


Mean ( SE ) changes vs. placebo in LDL-C were greatest in the high-dose groups : -68.6 ( 3.0 ) % and -63.9 ( 3.2 ) % with 140 mg Q2W and 420 mg QM dosing , respectively .


Up to 96 % of evolocumab-treated patients achieved LDL-C < 1.8 mmol/L .


Adverse events ( AEs ) were more frequent in evolocumab ( 51 % ) vs. placebo ( 38 % ) patients ; 4 patients taking evolocumab discontinued treatment because of an AE .


There were no significant differences in AE rates based on dose or dose frequency .


In Japanese patients at high cardiovascular risk with hypercholesterolemia on stable statin therapy , evolocumab significantly reduced LDL-C and was well tolerated during this 12-week study .


To assess change in overactive bladder ( OAB ) symptoms up to 5 years after surgery and to identify associated predictors of change from baseline .


This is a secondary analysis of data from three multicenter urinary incontinence ( UI ) surgical trials of women with stress-predominant mixed UI assigned to Burch colposuspension , autologous fascial sling , or retropubic or transobturator midurethral slings .


The primary outcome was improvement of 70 % or greater from baseline in symptoms measured by the Urinary Distress Inventory-Irritative subscale .


Surgical groups were compared within respective trials .


Generalized linear models were fit using 1-year and up to 5-year data .


Significant improvements in Urinary Distress Inventory-Irritative scores were reported by each surgical group 1 year after surgery ( P < .001 ) .


Most women ( 50-71 % ) reported improvement in OAB symptoms .


Improvements were similar between midurethral sling groups at 1 year ( 65.5 % compared with 70.7 % , P = .32 ; odds ratio [ OR ] 0.83 , 95 % confidence interval [ CI ] 0.57-1 .20 for retropubic compared with transobturator sling ) and throughout the 5-year follow-up period .


More women reported OAB symptom improvement after Burch compared with pubovaginal sling ( 67.9 % compared with 56.6 % , P = .01 ; OR 1.59 , 95 % CI 1.10-2 .31 for Burch compared with sling ) ; this group difference at 1 year persisted throughout the 5-year follow-up .


At 1-year , 50.0-64 .3 % of patients reported 70 % greater improvement in UI .


This proportion declined to 36.5-54 .1 % at 5 years ( P < .001 ) .


Preoperative use of anticholinergics and urodynamic parameters was not predictive of OAB symptom change after surgery .


Most women with stress-predominant mixed UI experienced significant improvement in OAB symptoms after incontinence surgery although this initial improvement diminished over time .


Obesity blunted symptom improvement .


II .


Early recurrence of atrial fibrillation ( ERAF ) is common after radiofrequency catheter ablation for AF .


We sought to determine the incidence and prognostic significance of ERAF after cryoballoon ablation .


Moreover , the benefit of early reablation for ERAF after cryoballoon ablation is undetermined .


The Sustained Treatment of Paroxysmal Atrial Fibrillation ( STOP AF ) trial randomized 245 patients with paroxysmal AF to medical therapy versus cryoballoon-based pulmonary vein ablation .


Patients were followed for 12 months .


ERAF was defined as any recurrence of AF > 30 seconds during the first 3 months of follow-up .


Late recurrence ( LR ) was defined as any recurrence of AF > 30 seconds between 3 and 12 months .


Of the 163 patients randomized to cryoablation , 84 patients experienced ERAF ( 51.5 % ) .


The only significant factor associated with ERAF was male sex ( hazard ratio [ HR ] , 2.18 ; 95 % confidence interval [ CI ] , 1.03-4 .61 ; P = 0.041 ) .


LR was observed in 41 patients ( 25.1 % ) , and was significantly related to ERAF ( 55.6 % LR with ERAF versus 12.7 % without ERAF ; P < 0.001 ) .


Among patients with ERAF , only current tobacco use ( HR , 3.84 ; 95 % CI , 1.82-8 .11 ; P < 0.001 ) was associated with LR .


Conversely , early reablation was associated with greater freedom from LR ( 3.3 % LR with early reablation versus 55.6 % without ; HR , 0.04 ; 95 % CI , 0.01-0 .32 ; P = 0.002 ) .


ERAF after cryoballoon ablation occurs in 50 % of patients and is strongly associated with LR .


Early reablation for ERAF is associated with excellent long-term freedom from recurrent AF .


A new model of complex diabetes care is provided by a multidisciplinary team which incorporates general practitioner ( GP ) Clinical Fellows supported by an Endocrinologist and diabetes educator within a community-based general practice setting .


This study evaluates the health and clinical benefits of the new model of care , assesses the acceptability of the model to patients , GPs and other health professionals , and examines the cost-effectiveness of the model .


The study is an open , non-inferiority randomised controlled trial with data collected at baseline , 6 and 12 months .


Participants are identified from new patients on hospital-based diabetes outpatient clinic waiting lists and new GP referrals .


Eligible consenting patients are randomised to either a community practice site ( intervention ) or a hospital site ( usual care ) .


In the intervention model , medical care is led by a GP Clinical Fellow in partnership with an Endocrinologist .


Quantitative measures include clinical indicators with HbA1c as the primary outcome ; patient-reported outcomes include health-related quality of life , mental health and satisfaction with care .


Qualitative methods will be used to explore the perspectives and experiences of patients and providers regarding the new model of care .


An economic evaluation will also be undertaken .


This model of care seeks to improve the quality and safety of healthcare at the interface between the hospital and primary care sectors for patients with complex diabetes .


The study will provide empirical evidence about the impact of the model of care on health outcomes , patient and clinician satisfaction , as well as any economic impacts .


Clinical Trials Registry Number : ACTRN12612000380897 .


The effect of hypoglycemia related to treatment of type 2 diabetes mellitus ( T2DM ) on brain structure remains unclear .


We aimed to assess whether symptomatic severe hypoglycemia is associated with brain atrophy and/or white matter abnormalities .


We included T2DM participants with brain MRI from the Action to Control Cardiovascular Risk in Diabetes-Memory in Diabetes ( ACCORD-MIND ) trial .


Symptomatic severe hypoglycemia was defined as blood glucose < 2.8 mmol/L or symptoms resolved with treatments that required the assistance of another person or medical assistance ( hypoglycemia requiring assistance [ HA ] ) .


Standardized brain MRI was performed at baseline and at 40 months .


Total brain volume ( TBV ) and abnormal white matter ( AWM ) volume were calculated using an automated computer algorithm .


Brain MRI scans of hypoglycemic participants were also reviewed for local disease .


Of the 503 T2DM participants ( mean age , 62 years ) with successful baseline and 40-month brain MRI , 28 had at least one HA episode during the 40-month follow-up .


Compared with participants without HA , those with HA had marginally significant less atrophy ( less decrease in TBV ) from baseline to 40 months ( -9.55 [ 95 % CI -15.21 , -3.90 ] vs. -15.38 [ 95 % CI -16.64 , -14.12 ] , P = 0.051 ) , and no significant increase of AWM volume ( 2.06 [ 95 % CI 1.71 , 2.49 ] vs. 1.84 [ 95 % CI 1.76 , 1.91 ] , P = 0.247 ) .


In addition , no unexpected local signal changes or volume loss were seen on hypoglycemic participants ' brain MRI scans .


Our study suggests that hypoglycemia related to T2DM treatment may not accentuate brain pathology , specifically brain atrophy or white matter abnormalities .


Emotional support has traditionally been conceived as something a breast cancer patient receives .


However , this framework may obscure a more complex process , facilitated by the emerging social media environment , which includes the effects of composing and sending messages to others .


Accordingly , this study explores the effects of expression and reception of emotional support messages in online groups and the importance of bonding as a mediator influencing the coping strategies of breast cancer patients .


Data were collected as part of two National Cancer Institute-funded randomized clinical trials .


Eligible subjects were within 2 months of diagnosis of primary breast cancer or recurrence .


Expression and reception of emotionally supportive messages were tracked and coded for 237 breast cancer patients .


Analysis resulted from merging 1 ) computer-aided content analysis of discussion posts , 2 ) action log analysis of system use , and 3 ) longitudinal survey data .


As expected , perceived bonding was positively related to all four coping strategies ( active coping : = 0.251 , P = .000 ; positive reframing : = 0.288 , P = .000 ; planning : = 0.213 , P = .006 ; humor : = 0.159 , P = .009 ) .


More importantly , expression ( = 0.138 , P = .027 ) , but not reception ( = -0.018 , P = .741 ) , of emotional support increases perceived bonding , which in turn mediates the effects on patients ' positive coping strategies .


There is increasing importance for scholars to distinguish the effects of expression from reception to understand the processes involved in producing psychosocial benefits .


This study shows that emotional support is more than something cancer patients receive ; it is part of an active , complex process that can be facilitated by social media .


Efavirenz is widely prescribed for HIV-1 infection , and CYP2B6 polymorphisms 516GT and 983TC define efavirenz slow metabolizer genotypes .


To identify genetic predictors of higher plasma efavirenz concentrations beyond these two common functional alleles , we characterized associations with mid-dosing interval efavirenz concentrations in 84 HIV-infected adults , all carrying two copies of these major loss-of-function CYP2B6 alleles .


Study participants had been randomized to efavirenz-containing regimens in prospective clinical trials and had available plasma efavirenz assay data .


Analyses focused on secondary metabolism pathway polymorphisms CYP2A6 -48 TG ( rs28399433 ) , UGT2B7 735AG ( rs28365062 ) and UGT2B7 802TC ( rs7439366 ) .


Exploratory analyses also considered 196 polymorphisms and 8 copy number variants in 41 drug metabolism/transport genes .


Mid-dosing interval efavirenz concentrations at steady-state were obtained 8 h but < 19 h post-dose .


Linear regression was used to test for associations between polymorphisms and log-transformed efavirenz concentrations .


Increased efavirenz concentrations were associated with CYP2A6 -48 TG in all subjects ( P = 3.810 ( -4 ) ) and in Black subjects ( P = 0.027 ) and White subjects ( P = 0.0011 ) analysed separately ; and with UGT2B7 735 G/G homozygosity in all subjects ( P = 0.006 ) and in Black subjects ( P = 0.046 ) and White subjects ( P = 0.062 ) analysed separately .


In a multivariable model , CYP2A6 -48 TG and UGT2B7 735 G/G homozygosity remained significant ( P < 0.05 for each ) .


No additional polymorphisms or copy number variants were significantly associated with efavirenz concentrations .


Among individuals with a CYP2B6 slow metabolizer genotype , CYP2A6 and possibly UGT2B7 polymorphisms contribute to even higher efavirenz concentrations .


Retrospective series report varied rates of bleeding and infection with external ventricular drainage ( EVD ) .


There have been no prospective studies of these risks with systematic surveillance , threshold definitions , or independent adjudication .


To analyze the rate of complications in the ongoing Clot Lysis : Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III ( CLEAR III ) trial , providing a comparison with a systematic review of complications of EVD in the literature .


Patients were prospectively enrolled in the CLEAR III trial after placement of an EVD for obstructive intraventricular hemorrhage and randomized to receive recombinant tissue-type plasminogen activator or placebo .


We counted any detected new hemorrhage ( catheter tract hemorrhage or any other distant hemorrhage ) on computed tomography scan within 30 days from the randomization .


Meta-analysis of published series of EVD placement was compiled with STATA software .


Growing or unstable hemorrhage was reported as a cause of exclusion from the trial in 74 of 5707 cases ( 1.3 % ) screened for CLEAR III .


The first 250 patients enrolled have completed adjudication of adverse events .


Forty-two subjects ( 16.8 % ) experienced 1 new bleeds or expansions , and 6 of 250 subjects ( 2.4 % ) suffered symptomatic hemorrhages .


Eleven cases ( 4.4 % ) had culture-proven bacterial meningitis or ventriculitis .


Risks of bleeding and infection in the ongoing CLEAR III trial are comparable to those previously reported in EVD case series .


In the present study , rates of new bleeds and bacterial meningitis/ventriculitis are very low despite multiple daily injections , blood in the ventricles , the use of thrombolysis in half the cases , and generalization to > 60 trial sites .


To assess the impact of between-training-sessions recovery strategies ( passive [ PAS ] , active [ ACT ] , cold-water immersion [ CWI ] , and ingestion of a recovery drink [ NUTR ] ) on maximal cycling performance , perceptions of delayed-onset muscle soreness ( DOMS ) , and fatigue in world-class BMX riders .


Eleven elite BMX athletes , members of the French national team ( top country in the 2011 international ranking , 4 medals at the 2012 World Championships , top European country ) , participated in the study , which involved standardized training periods .


Athletes performed 3 maximal-sprint power tests : the first day of the week before the training session and before and after training on the third day of the week ( D3 ) .


The recovery strategy was randomly assigned to each participant on day 2 immediately after the last training period of the day .


Perceptions of DOMS and general fatigue were recorded on D3 .


After training on D3 , the decrease in maximal-sprint power ( Pmax ) was significantly greater for PAS than with CWI ( P = .02 ) and NUTR ( P = .018 ) .


Similar results were found with ACT ( vs CWI P = .044 , and vs NUTR P = .042 ) .


Self-reported DOMS and fatigue were significantly greater after PAS than after other strategies .


For elite BMX riders , between training days , nutritional and/or CWI recovery strategies appear to be best for reducing muscle fatigue and increasing the capacity to withstand the training schedule .


In this randomized clinical trial ginger efficacy for prevention of antiretroviral-induced nausea and vomiting ( N/V ) was investigated .


From July 2011 until the end of June 2013 , 102 HIV positive patients attending the HIV clinic of Imam Khomeini Hospital participated in the study .


In a double blinded manner , participants randomly received either 500 mg ginger or placebo two times per day , 30 min before each dose of antiretroviral regimen for 14 days .


The severity of nausea was assessed based on the visual analogue scale .


The number of vomiting episodes were also recorded during the study period .


A total of 46 ( 90.2 % ) and 29 ( 56.4 % ) of the patients in placebo and ginger groups experienced some degree of nausea during the first 2 weeks of antiretroviral therapy ( ART ) , respectively ( p = 0.001 ) .


Frequency of mild , moderate and severe nausea were significantly lower in the ginger than placebo group ( p = 0.001 ) .


Also , 24 ( 47.1 % ) and 5 ( 9.8 % ) of the patients in the placebo and ginger groups reported at least one episode of vomiting during their time on ART , respectively ( p = 0.01 ) .


Ginger was effective in ameliorating of antiretroviral-induced N/V .


Chronic myeloid leukemia ( CML ) treatment relies on tyrosine kinase inhibitors ( TKIs ) , but their use can be associated with low-grade adverse events ( AEs ) .


This analysis aimed to identify the low-grade AEs which significantly impact the Health Related Quality of Life ( HRQoL ) of CML patients in chronic phase ( CP ) and to compare the incidence of such AEs among nilotinib - and imatinib-treated patients .


Data from the 48 month ENESTnd trial were used ( N = 593 patients ) .


HRQoL was assessed using generic ( SF-36 ) and leukemia-specific ( FACT-Leu ) HRQoL surveys .


AEs were categorized into 26 system organ classes .


In the adjusted regression model , five low-grade AE categories - gastrointestinal disorders , blood and lymphatic system disorders , general disorders and administration site conditions , musculoskeletal disorders , and psychiatric disorders - significantly impaired at least one HRQoL score .


The incidence rate of these five AE categories was either significantly lower for nilotinib than imatinib or not different between the two drugs .


The AE categories with lower incidence for both nilotinib 300mg BID and 400mg BID versus imatinib 400mg daily were gastrointestinal , blood and lymphatic system , and musculoskeletal ; nilotinib 300mg BID had lower incidence than imatinib for general disorders .


Low-grade AEs were grouped and analyzed by system organ class category , so the effect of some rare individual AEs on HRQoL may have been missed .


The impact of low-grade AEs on HRQoL should be taken into account , along with other factors , when selecting the optimal treatment for patients newly diagnosed with CML-CP .


To assess the difference between drainage and non-drainage after total hip arthroplasty ( THA ) in Chinese subjects by evaluating post-operative complications and joint function .


One hundred and sixty-eight patients undergoing THA were randomly allocated into drainage ( 83 patients ) and non-drainage groups ( 85 patients ) .


All surgeries were performed by one surgical team using the same pre - , intra - , and postoperative techniques .


Measured items included : hemoglobin ( Hb ) , superficial and deep wound infection , volume of blood transfusion , wound hematoma thickness , range of motion ( ROM ) of the hip , wound healing time , ecchymosis and tension vesicles around the wound .


Early after THA , the Hb decreased significantly in the drainage group .


There was no significant difference between non-drainage and drainage groups in need for or volume of blood transfusions ( 9.6 % vs 8.2 % , P = 0.100 ; 3.8 units vs 2.9 units , P = 0.089 , respectively ) .


In the non-drainage group , the incidence of superficial infection , ecchymosis and tension vesicles was significantly higher than in the drainage group ( 10.6 % vs 2.4 % , P = 0.031 ; 12.9 % vs 3.6 % , P = 0.026 ; 16.5 % vs 4.8 % , P = 0.013 , respectively ) .


In addition , the non-drainage group had a greater volume of hematomas ( P = 0.000 ) .


Patients in the non-drainage group had smaller ROMs early after surgery but the final ROMs did not differ significantly between groups .


No deep infection occurred in either group .


Non-drainage may reduce postoperative blood loss but has no benefits regarding blood transfusion or deep infection .


It may cause more post-operative complications because of restriction of early postoperative exercise by pain and swelling .


Therefore we suggest routine use of drainage after THA .


Using the reverse Trendelenburg position ( RTP ) during functional endoscopic sinus surgery ( FESS ) is a safe , simple , and cost-free method that has been found to reduce intraoperative blood loss .


However , the critical angle of RTP that produces the least amount of bleeding without compromising surgical technique and safety remains unanswered .


The objective of this study was to assess the effects of 5-degree , 10-degree , and 20-degree RTP ( 5-RTP , 10-RTP , and 20-RTP , respectively ) on intraoperative bleeding during FESS .


This double-blind randomized controlled trial involved 75 patients with chronic rhinosinusitis ( CRS ) with and without nasal polyposis undergoing FESS .


Twenty-five patients were enrolled into each group : 5-RTP , 10-RTP , and 20-RTP .


Boezaart endoscopic field-of-view score ( BS ) , total blood loss ( TBL ) , mean arterial blood pressure ( MABP ) , operating time , and blood loss per minute were recorded .


An intention-to-treat analysis was used , with a Bonferroni adjustment for multiple comparisons .


Intervention groups were comparable in age , sex , nasal polyposis , and disease severity .


Mean values of BS and TBL were as follows : 5-RTP ( 2.0 , 231 mL ) , 10-RTP ( 1.8 , 230 mL ) , and 20-RTP ( 1.4 , 135 mL ) .


The differences in means were significant for BS ( p < 0.01 ) and TBL ( p = 0.03 ) .


There was no significant difference in MABP ( p = 0.85 ) , operating time ( p = 0.10 ) , or blood loss per minute ( p = 0.11 ) between the 3 groups .


Pairwise comparison between 5-RTP vs 20-RTP found significant difference in BS ( p < 0.01 ) but not TBL ( p = 0.04 ) .


Significance was not found in similar comparisons of 10-RTP vs 20-RTP and 5-RTP vs 10-RTP ( p > 0.03 ) .


FESS in 20-RTP produced the best BS and lowest blood loss without compromising surgical technique .


This paper aimed to develop a short version of the 32-item Ageing Perceptions Questionnaire ( APQ ) , a multi-dimensional measure based on Leventhal 's self-regulation model .


Ageing perceptions are a key area of interest for large-scale surveys of ageing populations .


As these studies capture a broad range of health and social variables , included instruments need to be as concise as possible .


Data from the Irish Longitudinal Study of Ageing ( TILDA ) , a representative sample of community-dwelling individuals aged 50 + ( n = 6,718 ) , was used to revise the scale .


Items for exclusion were identified by examining conceptual content , descriptive statistics , and by detecting sources of poor model fit using confirmatory factor analysis ( CFA ) .


Potential combinations of dimensions were also tested using CFA .


Finally , we identified any dimensions that could be excluded without limiting the conceptual coverage and coherence of the scale .


Model modifications were done sequentially and with regard to theoretical considerations .


Internal consistency and construct validity of the concise scale were compared with the longer version .


Initially , 11 items were excluded on the basis of conceptual and empirical overlap with other items .


CFA indicated that the negative-control and negative-consequences dimensions could be combined , allowing us to exclude a further item from this dimension .


The 5-item timeline-cyclical dimension was also excluded , as it was less well-established conceptually and empirically than the other dimensions .


The final 17-item , 5-dimension model was consistent with the original conceptual model and fit the data well ( chi-sq = 1433.54 , df ( 109 ) , p < 0.01 , RMSEA = 0.04 , CFI = 0.97 , TLI = 0.96 ) .


The Brief-APQ ( B-APQ ) is a concise , multi-dimensional measure of ageing perceptions , which is psychometrically valid for use with the Irish population aged 50 + .


The concise version preserved the internal consistency and construct validity of the original .


Its brevity makes it particularly suitable for use with large-scale adult population surveys .


The psychometric analysis supports the application of the self-regulation model to ageing perceptions , but also the existence of distinct `` physical decline '' and `` ongoing development '' dimensions of perceptions .


Organized screening based on Pap tests has substantially reduced deaths from cervical cancer in many countries , including Australia .


However , the impact of the program depends upon the degree to which women participate .


A new method of screening , testing for human papillomavirus ( HPV ) DNA to detect the virus that causes cervical cancer , has recently become available .


Because women can collect their own samples for this test at home , it has the potential to overcome some of the barriers to Pap tests .


The iPap trial will evaluate whether mailing an HPV self-sampling kit increases participation by never - and under-screened women within a cervical screening program .


The iPap trial is a parallel randomized controlled , open label , trial .


Participants will be Victorian women age 30-69 years , for whom there is either no record on the Victorian Cervical Cytology Registry ( VCCR ) of a Pap test ( never-screened ) or the last recorded Pap test was between five to fifteen years ago ( under-screened ) .


Enrolment information from the Victorian Electoral Commission will be linked to the VCCR to determine the never-screened women .


Variables that will be used for record linkage include full name , address and date of birth .


Never - and under-screened women will be randomly allocated to either receive an invitation letter with an HPV self-sampling kit or a reminder letter to attend for a Pap test , which is standard practice for women overdue for a test in Victoria .


All resources have been focus group tested .


The primary outcome will be the proportion of women who participate , by returning an HPV self-sampling kit for women in the self-sampling arm , and notification of a Pap test result to the Registry for women in the Pap test arm at 3 and 6 months after mailout .


The most important secondary outcome is the proportion of test-positive women who undergo further investigations at 6 and 12 months after mailout of results .


The iPap trial will provide strong evidence about whether HPV self-sampling could be used in Australia to improve participation in cervical screening for never-and under-screened women .


ANZCTR Identifier : ACTRN12613001104741 ; UTN : U1111-1148-3885 .


eHealth interventions are effective for weight control and have the potential for broad reach .


Little is known about the use of interactive voice response ( IVR ) technology for self-monitoring in weight control interventions , particularly among populations disproportionately affected by obesity .


This analysis sought to examine patterns and predictors of IVR self-monitoring adherence and the association between adherence and weight change among low-income black women enrolled in a weight gain prevention intervention .


The Shape Program was a randomized controlled trial comparing a 12-month eHealth behavioral weight gain prevention intervention to usual care among overweight and obese black women in the primary care setting .


Intervention participants ( n = 91 ) used IVR technology to self-monitor behavior change goals ( eg , no sugary drinks , 10,000 steps per day ) via weekly IVR calls .


Weight data were collected in clinic at baseline , 6 , and 12 months .


Self-monitoring data was stored in a study database and adherence was operationalized as the percent of weeks with a successful IVR call .


Over 12 months , the average IVR completion rate was 71.6 % ( SD 28.1 ) and 52 % ( 47/91 ) had an IVR completion rate 80 % .


At 12 months , IVR call completion was significantly correlated with weight loss ( r = -.22 ; P = .04 ) and participants with an IVR completion rate 80 % had significantly greater weight loss compared to those with an IVR completion rate < 80 % ( -1.97 kg , SE 0.67 vs 0.48 kg , SE 0.69 ; P = .01 ) .


Similar outcomes were found for change in body mass index ( BMI ; mean difference -0.94 kg , 95 % CI -1.64 to -0.24 ; P = .009 ) .


Older , more educated participants were more likely to achieve high IVR call completion .


Participants reported positive attitudes toward IVR self-monitoring .


Adherence to IVR self-monitoring was high among socioeconomically disadvantaged black women enrolled in a weight gain prevention intervention .


Higher adherence to IVR self-monitoring was also associated with greater weight change .


IVR is an effective and useful tool to promote self-monitoring and has the potential for widespread use and long-term sustainability .


Clinicaltrials.gov NCT00938535 ; http://www.clinicaltrials.gov/ct2/show/NCT00938535 .


To compare the clinical efficacy of co-induction with propofol-midazolam-ketamine with etomidate as the sole induction agent .


Prospective , double-blinded , randomized controlled trial .


Operating room of a university hospital .


60 ASA physical status 1 and 2 patients scheduled for limited elective surgery requiring general anesthesia .


Patients were randomized to two groups to receive etomidate 0.3 mg/kg ( single-drug group ) or propofol 0.6 mg/kg + ketamine 0.8 mg/kg + midazolam 0.06 mg/kg ( three-drug group ) .


Hemodynamic responses ( systolic and diastolic blood pressure , and mean arterial pressure ) were examined at baseline and at one , three , and 5 minutes after tracheal intubation .


Plasma catecholamine levels were measured at baseline , one , and 5 minutes after tracheal intubation .


Heart rate ( HR ) changes differed significantly between the two groups at three minutes ( P = 0.01 ) and 5 minutes ( P = 0.00 ) after tracheal intubation .


However , the HR increase in the three-drug group was in the acceptable range .


Percentage changes of epinephrine level differed between the two groups at 5 minutes after tracheal intubation ( P = 0.03 ) .


The higher norepinephrine/epinephrine ratio noted in the single-drug group may be implicated in lower adrenal sympathetic activity .


Propofol-midazolam-ketamine co-induction may be used instead of etomidate for anesthesia induction in patients with hemodynamic instability .


Systemic inflammation beyond the skin may provide an explanation of the increased cardiovascular risk observed in psoriasis .


It was hypothesized that neutrophil-to-lymphocyte ratio ( NLR ) and platelet-to-lymphocyte ratio ( PLR ) are potential predictors of subclinical atherosclerosis measured by aortic velocity propagation ( AVP ) and carotid intima-media thickness ( CIMT ) in psoriasis .


Fifty-one patients with psoriasis taking no antipsoriatic therapy and 37 age - and sex-matched healthy controls were prospectively enrolled .


The Psoriasis Area and Severity Index ( PASI ) was calculated .


Complete blood counts were obtained .


Measurements of AVP and CIMT were performed .


The baseline clinical and demographic features , and white blood cell , platelet , neutrophil , lymphocyte , monocyte , and PLR were similar in both groups .


NLR and high-sensitivity C-reactive protein ( hs-CRP ) were higher in the psoriasis group than the control group ( P = 0.001 , P < 0.001 ; respectively ) .


The psoriasis group had lower AVP and higher CIMT values than those of controls ( AVP : 48.918.1 vs. 64.314.5 cm/sec ; P < 0.001 , CIMT : 0.840.29 vs. 0.630.27 mm ; P = 0.001 , respectively ) .


PASI was positively correlated with NLR and hs-CRP ( r = 0.423 , P = 0.002 ; r = 0.315 , P = 0.024 , respectively ) .


There was an inverse association between AVP and CIMT ( r = -0.749 , P < 0.001 ) .


Binary logistic regression analysis demonstrated that NLR was the only variable able to predict lower AVP ( 41cm/sec ) and higher CIMT ( > 0.9 mm ) values ( P = 0.024 and 0.023 ; respectively ) .


NLR is potentially an unrecognized predictor of subclinical atherosclerosis in patients with psoriasis .


Future studies assessing the prognostic significance of NLR on cardiovascular event rates in psoriasis patients would be of great interest .


To analyze , using in vivo laser scanning confocal microscopy ( LSCM ) , the conjunctival features in glaucomatous patients receiving prostaglandin analogues ( PGA ) .


Eighty eyes of 80 consecutive glaucomatous patients naive for therapy were enrolled ; 30 eyes of 30 healthy subjects served as a control .


Patients were randomized to : preservative-free ( PF ) and preserved latanoprost ( groups 1 and 2 , respectively ) , PF and preserved timolol ( groups 3 and 4 ) , and controls to vehicle of latanoprost or physiological buffered saline solution ( groups 5 and 6 ) .


All subjects underwent LSCM of bulbar conjunctiva at baseline and 3 months after initiating therapy .


The main outcomes were : mean density ( MMD : cysts/mm ( 2 ) ) and mean area ( MMA : cysts/mm ( 2 ) ) of epithelial microcysts .


The relations between MMA and MMD with intraocular pressure ( IOP ) , age , and mean defect ( MD ) , were analyzed .


At baseline , microcysts were found in all subjects .


At month three , MMD did not change in all groups ( p > 0.05 ) .


MMA significantly increased only in group 1 from 2,158.81524.09 to 3,877.77867.31 , and in group 2 from 2,019.71541.03 to 5,560.391,176.14 , with values significantly higher in group 2 ( p < 0.001 ) .


Significant relations were not found between MMD and MMA with IOP , MD , and age ( p > 0.05 ) .


PGA increased MMA in therapy-naive glaucomatous patients , indicating a possible enhancement of the trans-conjunctival aqueous humor outflow .


Therefore , conjunctiva seems an additional target tissue to evaluate the hydrodynamic pathways in glaucoma and modifications induced by medical therapy .


Healthcare providers play an important role in encouraging healthy behaviors and improving health-related quality of life ( HRQoL ) .


They are most effective when they partner with informed , engaged patients .


To examine the impact of a new health-information technology intervention ( FAST-Feedback ) that provides patients with immediate , personalized , guideline-based feedback regarding tobacco use , physical activity , and HRQoL , and encourages patients to initiate discussions regarding these topics with their primary care physician .


A pilot , randomized controlled trial clustered by resident physician , with patients as the unit of analysis .


Resident physicians and their out-patients in a single academic health center between May and October 2011 .


Patients received ( intervention ) or did not receive ( control ) FAST-Feedback prior to the clinical encounter .


Primary outcomes were patient reports of initiating any discussions regarding tobacco use , physical activity , and HRQoL .


Subgroup analyses examined patient reports of discussions regarding tobacco use , physical activity , and HRQoL , respectively .


Thirty of the 36 eligible resident physicians ( 83 % ) agreed to participate ; 173 of their 415 eligible patients ( 42 % ) expressed interest in the study and 99 ( 24 % ) consented to participate .


Compared to controls , a higher percentage of intervention patients reported initiating any discussion with their resident physician , although this difference was not statistically significant ( 40 % vs. 27 % ; p = 0.12 ) .


For subgroup analyses regarding specific topics of discussion , patients in the intervention group reported initiating more discussions regarding mental HRQoL than controls ( 23 % vs. 0 % ; p = 0.02 ) .


There was no difference in patient reports of initiating discussions regarding smoking , physical activity or physical HRQoL .


Providing patients with immediate , personalized , guideline-based feedback prior to the clinical encounter can increase patient-initiated discussions regarding mental HRQoL .


Future work should test FAST-Feedback in a larger population and evaluate the impact on tobacco cessation , increased physical activity , and improvements in HRQoL .


Rheumatoid arthritis ( RA ) is chronic systematic disease that affects people during the most productive period of their lives .


Web-based health interventions have been effective in many studies ; however , there is little evidence and few studies showing the effectiveness of online social support and especially gamification on patients ' behavioral and health outcomes .


The aim of this study was to look into the effects of a Web-based intervention that included online social support features and gamification on physical activity , health care utilization , medication overuse , empowerment , and RA knowledge of RA patients .


The effect of gamification on website use was also investigated .


We conducted a 5-arm parallel randomized controlled trial for RA patients in Ticino ( Italian-speaking part of Switzerland ) .


A total of 157 patients were recruited through brochures left with physicians and were randomly allocated to 1 of 4 experimental conditions with different types of access to online social support and gamification features and a control group that had no access to the website .


Data were collected at 3 time points through questionnaires at baseline , posttest 2 months later , and at follow-up after another 2 months .


Primary outcomes were physical activity , health care utilization , and medication overuse ; secondary outcomes included empowerment and RA knowledge .


All outcomes were self-reported .


Intention-to-treat analysis was followed and multilevel linear mixed models were used to study the change of outcomes over time .


The best-fit multilevel models ( growth curve models ) that described the change in the primary outcomes over the course of the intervention included time and empowerment as time-variant predictors .


The growth curve analyses of experimental conditions were compared to the control group .


Physical activity increased over time for patients having access to social support sections plus gaming ( unstandardized beta coefficient [ B ] = 3.39 , P = .02 ) .


Health care utilization showed a significant decrease for patients accessing social support features ( B = -0.41 , P = .01 ) and patients accessing both social support features and gaming ( B = -0.33 , P = .03 ) .


Patients who had access to either social support sections or the gaming experience of the website gained more empowerment ( B = 2.59 , P = .03 ; B = 2.29 , P = .05 ; respectively ) .


Patients who were offered a gamified experience used the website more often than the ones without gaming ( t91 = -2.41 , P = .02 ; U = 812 , P = .02 ) .


The Web-based intervention had a positive impact ( more desirable outcomes ) on intervention groups compared to the control group .


Social support sections on the website decreased health care utilization and medication overuse and increased empowerment .


Gamification alone or with social support increased physical activity and empowerment and decreased health care utilization .


This study provides evidence demonstrating the potential positive effect of gamification and online social support on health and behavioral outcomes .


International Standard Randomized Controlled Trial Number ( ISRCTN ) : 57366516 ; http://www.controlled-trials .


com/ISRCTN57366516 ( Archived by webcite at http://www.webcitation.org/6PBvvAvvV ) .


Assessment of flow-mediated dilation ( FMD ) and nitroglycerin-mediated dilation ( NMD ) in the brachial artery by a new device ( UNEXEF18G ) has been reported to be excellent for evaluating endothelial function , and sympathetic overdrive can accelerate the atherosclerotic process .


The purpose of this study was to investigate and confirm whether anti-sympathetic beta-blocking action can enhance the pleiotropic effects of statins .


FMD and NMD were measured using the UNEXEF18G before and after 4-week treatment of rosuvastatin ( 5 mg/day ) with or without atenolol ( 25 mg/day ) in 44 hypercholesterolemic patients ( 708 years old , LDL-C > 140 mg/dL ) with hypertension .


Patients were randomly allocated to two treatment arms : rosuvastatin alone ( R-group , N. = 22 ) and rosuvastatin with atenolol ( RA-group , N. = 22 ) .


Baseline FMD was not different between the two treatment arms , and both groups showed improvement in FMD ( R-group , 3.481.9 % to 4.652.41 % , P < 0.05 ; RA-group , 3.421.48 % to 5.461.79 % , P < 0.05 ) , while there were no differences in NMD .


The effects on lipid profiles were identical in the two groups .


In addition , FMD improvement was greater in the RA-group than in the R-group ( change 2.151.29 % vs. 1.161.15 % , P < 0.05 ) .


Beta-blockade enhances the pleiotropic effects of statins on endothelial function .


The mechanism should be confirmed by further studies .


Women-initiated HIV-prevention products are urgently needed .


To address this need , a trial was conducted to assess the safety and pharmacokinetics of a silicone elastomer matrix vaginal ring containing 25 mg of the antiretroviral drug dapivirine when used continuously for 28 consecutive days .


A double-blind , randomized , placebo-controlled trial was conducted in 16 healthy , HIV-negative women , 18-40 years of age , who were randomized 1:1 to use either the active or matching placebo ring for 28 days .


Participants were followed during and for 28 days after ring use for safety and pharmacokinetic evaluations .


The dapivirine vaginal ring was safe and well tolerated with no differences in safety endpoints between the active and placebo ring .


The concentration-time plots of dapivirine in vaginal fluid were indicative of a sustained release of dapivirine over the 28 days of use .


Dapivirine vaginal fluid concentrations were highest near the ring , followed by the cervix and introtus ( mean Cmax of 80 , 67 and 31 g/g , respectively ) .


Vaginal fluid concentrations of dapivirine on the day of ring removal ( day 28 ) at all three collection sites exceeded by more than 3900-fold the IC99 for dapivirine in a tissue explant infection model .


Plasma dapivirine concentrations were low ( < 1 ng/ml ) and remained well below those observed at the maximum tolerated dose for oral treatment ( mean Cmax of 2286 ng/ml ) .


The dapivirine vaginal ring has a safety and pharmacokinetic profile that supports its use as a sustained-release topical microbicide for HIV-1 prevention in women .


Collaborative care is an effective treatment for the management of depression but evidence on its cost-effectiveness in the UK is lacking .


To assess the cost-effectiveness of collaborative care in a UK primary care setting .


An economic evaluation alongside a multi-centre cluster randomised controlled trial comparing collaborative care with usual primary care for adults with depression ( n = 581 ) .


Costs , quality-adjusted life-years ( QALYs ) , and incremental cost-effectiveness ratios ( ICER ) were calculated over a 12-month follow-up , from the perspective of the UK National Health Service and Personal Social Services ( i.e. Third Party Payer ) .


Sensitivity analyses are reported , and uncertainty is presented using the cost-effectiveness acceptability curve ( CEAC ) and the cost-effectiveness plane .


The collaborative care intervention had a mean cost of 272.50 per participant .


Health and social care service use , excluding collaborative care , indicated a similar profile of resource use between collaborative care and usual care participants .


Collaborative care offered a mean incremental gain of 0.02 ( 95 % CI : -0.02 , 0.06 ) quality-adjusted life-years over 12 months , at a mean incremental cost of 270.72 ( 95 % CI : -202.98 , 886.04 ) , and resulted in an estimated mean cost per QALY of 14,248 .


Where costs associated with informal care are considered in sensitivity analyses collaborative care is expected to be less costly and more effective , thereby dominating treatment as usual .


Collaborative care offers health gains at a relatively low cost , and is cost-effective compared with usual care against a decision-maker willingness to pay threshold of 20,000 per QALY gained .


Results here support the commissioning of collaborative care in a UK primary care setting .


Benefits of recombinant human growth hormone ( rhGH ) alone or combined with glutamine in patients with intestinal failure because of short-bowel syndrome remain controversial .


We explored effects of rhGH on whole-body protein metabolism in patients with short-bowel syndrome with intestinal failure ( SBS-IF ) to gain insight into its mechanism of action .


Eight stable hyperphagic patients with severe SBS-IF received , in a double-blind , randomized crossover study , low-dose rhGH ( 0.05 mg kg d ) and a placebo for two 3-wk periods .


Leucine and glutamine kinetics under fasting and fed conditions , fat-free mass ( FFM ) , and serum insulin were determined on the final day of each treatment .


rhGH increased FFM and nonoxidative leucine disposal ( NOLD ; an index of protein synthesis ) ( P < 0.02 ) , whereas FFM and NOLD were correlated in the fed state ( r = 0.81 , P = 0.015 ) .


With rhGH administration , leucine release from protein breakdown ( an index of proteolysis ) decreased in the fed compared with fasting states ( P = 0.012 ) , which was not observed with the placebo .


However , the fast-to-fed difference in leucine release from protein breakdown was not significantly different between rhGH and placebo ( P = 0.093 ) .


With rhGH , the intestinal absorption of leucine and glutamine increased ( P = 0.036 ) and correlated with serum insulin ( r = 0.91 , P = 0.002 ) .


rhGH increased glutamine de novo synthesis ( P < 0.02 ) and plasma concentrations ( P < 0.03 ) in both fasting and fed states .


In SBS-IF patients , feeding fails to decrease proteolysis in contrast to what is physiologically observed in healthy subjects .


rhGH enhances FFM through the stimulation of protein synthesis and might decrease proteolysis in response to feeding .


Improvements in de novo synthesis and intestinal absorption increase glutamine availability over the physiologic range , suggesting that beneficial effects of rhGH in hyperphagic patients might be achieved without glutamine supplementation .


Preliminary research shows ginger may be an effective adjuvant treatment for chemotherapy-induced nausea and vomiting but significant limitations need to be addressed before recommendations for clinical practice can be made .


In a double-blinded randomised-controlled trial , chemotherapy-nave patients will be randomly allocated to receive either 1.2 g of a standardised ginger extract or placebo per day .


The study medication will be administrated as an adjuvant treatment to standard anti-emetic therapy and will be divided into four capsules per day , to be consumed approximately every 4hours ( 300mg per capsule administered q.i.d ) for five days during the first three cycles of chemotherapy .


Acute , delayed , and anticipatory symptoms of nausea and vomiting will be assessed over this time frame using a valid and reliable questionnaire , with nausea symptoms being the primary outcome .


Quality of life , nutritional status , adverse effects , patient adherence , cancer-related fatigue , and CINV-specific prognostic factors will also be assessed .


Previous trials in this area have noted limitations .


These include the inconsistent use of standardized ginger formulations and valid questionnaires , lack of control for anticipatory nausea and prognostic factors that may influence individual CINV response , and the use of suboptimal dosing regimens .


This trial is the first to address these issues by incorporating multiple unique additions to the study design including controlling for CINV-specific prognostic factors by recruiting only chemotherapy-nave patients , implementing a dosing schedule consistent with the pharmacokinetics of oral ginger supplements , and independently analysing ginger supplements before and after recruitment to ensure potency .


Our trial will also be the first to assess the effect of ginger supplementation on cancer-related fatigue and nutritional status .


Chemotherapy-induced nausea and vomiting are distressing symptoms experienced by oncology patients ; this trial will address the significant limitations within the current literature and in doing so , will investigate the effect of ginger supplementation as an adjuvant treatment in modulating nausea and vomiting symptoms .


ANZCTR.org.au Identifier : ACTRN12613000120774 .


ANZMTG 01.07 WBRTMel is a phase 3 randomized trial to address the role of whole brain radiation therapy ( WBRT ) after local treatment of 1-3 melanoma brain metastases .


Modern radiation therapy technologies can now conformally spare the hippocampus during WBRT and therefore potentially reduce the risk of neurocognitive deficit .


The aims of this study were to report the prevalence of melanoma metastases within the hippocampal sparing region and to identify variables that correlate with the presence of metastases within the hippocampal sparing region .


The pre-local treatment MRI scans of 77 eligible WBRTMel patients were used to contour the individual metastasis and the hippocampus .


The volume , location and closest distance of each metastasis to the hippocampus were recorded .


Binary logistic regression was performed to assess the influence of factors on the location of a metastasis within 5mm of the hippocampus .


The median age was 61 and 66 % were male .


The distribution of the 115 metastases was frontal ( 50 , 43.5 % ) , parietal ( 23 , 20.0 % ) , temporal ( 13 , 11.2 % ) , occipital ( 18 , 15.7 % ) , cerebellum ( 10 , 8.6 % ) and pineal gland ( 1 , 1.0 % ) .


The median aggregate volume of the metastasis was 3516mm ( 3 ) .


None of the metastases were within the hippocampus .


Four patients ( 5.2 % ) had metastases within 5mm of the hippocampus .


The median distance from metastasis to the nearest hippocampus was 37.2 mm .


Only the total volume of metastases was a significant predictor for the risk of a metastasis within the hippocampal sparing region ( OR 1.071 , 95 % CI : 1.003-1 .144 , p = 0.040 ) .


This study confirmed a low incidence of melanoma metastasis in the hippocampal sparing region at diagnosis .


Given the lack of randomized data on the safety and benefit of hippocampal sparing WBRT , the current WBRTMel trial provides the opportunity to explore the feasibility of this technique .


To evaluate if a feasible , low-cost intervention could decrease the percentage of women gaining weight above the Institute of Medicine ( IOM ) recommendations on gestational weight gain ( GWG ) compared with standard maternity care .


A randomised controlled interventional design .


Antenatal clinics ( n = 14 ) in rebro county , Sweden , participated .


Healthy women with a body mass index ( BMI ) 19 kg/m ( 2 ) , age 18 years and adequate knowledge of Swedish language who signed in for maternity care at 16 weeks of gestation .


Standard care was compared with a composite intervention consisting of education on recommended GWG according to IOM , application of personalised weight graph , formalised prescription of exercise and regular monitoring of GWG at every antenatal visit .


The proportion of women gaining weight above IOM guidelines ( 1990 ) and mean GWG ( kg ) was compared between groups .


In all , 445 women were randomised and 374 women remained for analysis after delivery .


A majority of the women analysed were normal weight ( 72 % ) .


The intervention reduced the proportion of women who exceeded the IOM guidelines ( 41.1 % versus 50.0 % ) .


The reduction was , however , not statistically significant ( P = 0.086 ) .


Mean GWG was significantly lower among women receiving the intervention , 14.2 kg ( SD 4.4 ) versus 15.3 kg ( SD 5.4 ) in the standard care group ( P = 0.029 ) .


The low-cost intervention programme tested did significantly reduce the mean GWG but the proportion of women who exceeded the IOM recommendations for GWG was not significantly lower .


ClinicalTrials.gov Id NCT00451425 http://clinicaltrials.gov .


To evaluate the effectiveness of the Play and Language for Autistic Youngsters ( PLAY ) Project Home Consultation model , in combination with usual community services ( CS ) , to improve parent-child interaction , child development , and autism symptomatology in young children with autism spectrum disorders ( ASDs ) compared with CS only .


Children ( N = 128 ) with autism or PDD-NOS ( DSM-4 criteria ) aged 2 years 8 months to 5 years 11 months and recruited from 5 disability agencies in 4 US states were randomized in two 1-year cohorts .


Using videotape and written feedback within a developmental framework , PLAY consultants coached caregivers monthly for 12 months to improve caregiver-child interaction .


CS included speech/language and occupational therapy and public education services .


Primary outcomes included change in parent-child interactions , language and development , and autism-related diagnostic category/symptoms .


Secondary outcomes included parent stress and depression and home consultant fidelity .


Data were collected pre - and post-intervention .


Using intent-to-treat analysis ( ITT ) , large treatment effects were evident for parent and child interactional behaviors on the Maternal and Child Behavior Rating Scales .


Child language and developmental quotient did not differ over time by group , although functional development improved significantly .


PLAY children improved in diagnostic categories on the Autism Diagnostic Observation Schedule ( ADOS ) .


PLAY caregivers ' stress did not increase , and depressive symptomatology decreased .


Home consultants administered the intervention with fidelity .


PLAY intervention demonstrated substantial changes in parent-child interaction without increasing parents ' stress/depression .


ADOS findings must be interpreted cautiously because results do not align with clinical experience .


PLAY offers communities a relatively inexpensive effective intervention for children with ASD and their parents .


To assess the long-term effects of positive airway pressure ( PAP ) therapy on the ocular surface and eyelid in patients with obstructive sleep apnea hypopnea syndrome ( OSAHS ) .


Single-centred , prospective , and double-blinded study .


Fifty-one patients with OSAHS .


Fifty-one patients with OSAHS were treated with PAP for a period of 18 months .


The pre - and post-PAP values for eye examination scores ( presence of floppy eyelid syndrome [ FES ] , results of the Ocular Surface Disease Index [ OSDI ] questionnaire , Schirmer I test , tear film break-up time [ TBUT ] values , and corneal staining stages ) were compared .


Based on the apnea-hypopnea index , 17 patients were followed with moderate and 34 patients were followed with severe OSAHS .


The presence of FES before and after PAP was 56.9 % and 74.5 % ( p < 0.01 ) .


FES stage was determined as 1.41 0.98 before PAP and 0.78 0.78 after PAP ( p < 0.01 ) .


Pre-PAP and post-PAP OSDI results were 47.79 21.04 and 42.17 19.97 , respectively ( p < 0.01 ) .


Schirmer values before and after PAP were 7.23 1.95 and 8.49 1.79 mm , respectively ( p < 0.01 ) .


TBUT values before and after PAP were 7.11 1.82 and 8.68 1.76 seconds , respectively ( p < 0.01 ) .


Scores of the corneal staining stages before and after PAP were 1.05 0.75 and 0.68 0.54 , respectively ( p < 0.01 ) .


OSAHS is associated with low Schirmer and TBUT values , and high scores in OSDI questionnaire , and high corneal staining stage .


An appropriate PAP therapy helps to relieve both the systemic findings and the ocular surface problems most likely by providing a return to normal sleep patterns .


We believe that long-term ( at least 1 year ) use of PAP improves the clinical picture of FES and can overcome the problem of ocular irritation that is encountered in the early stage of PAP .


Coagulopathy is a major issue in children undergoing high-risk pediatric cardiac surgery .


Use of anti-fibrinolytics is well documented in adults , but recently there are questions raised about safety and effectiveness of their use on routine use .


Tranexamic acid is a potent anti-fibrinolytic , but its role is not fully understood in children .


This study aims to study the benefits tranexamic acid in controlling postoperative bleeding in pediatric cardiac surgical patients .


Fifty consecutive children who underwent cardiac surgery were randomized prospectively to receive either aprotinin ( Group A ; n = 24 ) or tranexamic acid ( Group B ; n = 26 ) from September 2009 to February 2010 were studied .


Primary end points were early mortality , postoperative drainage , reoperation for bleeding and complications .


Mean age and body weight was smaller in Group A ( Age : 48.55 vs. 64.73 months ; weight 10.75 vs. 14.80 kg ) respectively .


Group A had more cyanotic heart disease than Group B ( 87.5 % vs. 76.92 % ) .


Mean cardiopulmonary bypass time ( 144.33 vs. 84.34 min ) and aortic cross-clamp time ( 78.5 vs. 41.46 min ) were significantly higher in group A.


While the blood and products usage was significantly higher in Group A , there was no difference in indexed postoperative drainage in first 4 , 8 and 12 h and postoperative coagulation parameters .


Mean C-reactive protein was less in Group A than B and renal dysfunction was seen more in Group A ( 25 % vs. 7.6 % ) .


Mortality in Group A was 16.66 % and 7.6 % in Group B.


Anti-fibrinolytics have a definitive role in high-risk children who undergo open-heart surgery .


Tranexamic acid is as equally effective as aprotinin with no additional increase in morbidity or mortality .


An open-label , multicenter , randomized phase II trial was conducted from July 1 , 2005 to March 29 , 2011 to compare two protocols for treating children with frequently relapsing nephrotic syndrome using microemulsified cyclosporine .


Ninety-three children with frequently relapsing nephrotic syndrome were randomly assigned to group A ( n = 46 ) or group B ( n = 47 ) .


In both groups , the 2-hour postdose cyclosporine level was monitored .


For group A , the cyclosporine target was set to 600-700 ng/ml for the first 6 months and 450-550 ng/ml for the next 18 months ; for group B , it was set to 450-550 ng/ml for the first 6 months and 300-400 ng/ml for the next 18 months .


The primary end point was the sustained remission rate .


At the end of the study , if there was no difference in safety profile between the two groups and the sustained remission rate in group A was superior to group B with a decision threshold of 8 % , then the regimen for group A would be determined the better treatment .


Eight children from an ineligible institution , where cyclosporine levels were not measured , were excluded from all analyses .


At 24 months , the sustained remission rate was nonsignificantly higher in group A ( n = 43 ) than group B ( n = 42 ; 64.4 % versus 50.0 % ; hazard ratio , 0.57 ; 95 % confidence interval , 0.29 to 1.11 ; P = 0.09 ) , and the progression-free survival rate was significantly higher ( 88.1 % versus 68.4 % ; hazard ratio , 0.33 ; 95 % confidence interval , 0.12 to 0.94 ; P = 0.03 ) .


The relapse rate was significantly lower in group A than group B ( 0.41 versus 0.95 times/person-year ; hazard ratio , 0.43 ; 95 % confidence interval , 0.19 to 0.84 ; P = 0.02 ) .


The rate and severity of adverse events were similar in both treatment groups .


The sustained remission rate was not significantly different between the two treatment groups , but the regimen with the higher 2-hour postdose cyclosporine level target improved progression-free survival and reduced the relapse rate .


To compare the clinical usefulness of constant rate infusion ( CRI ) protocols of romifidine with or without butorphanol for sedation of horses .


Prospective ` blinded ' controlled trial using block randomization .


Forty healthy Freiberger stallions .


The horses received either intravenous ( IV ) romifidine ( loading dose : 80gkg ( -1 ) ; infusion : 30gkg ( -1 ) hour ( -1 ) ) ( treatment R , n = 20 ) or romifidine combined with butorphanol ( romifidine loading : 80gkg ( -1 ) ; infusion : 29gkg ( -1 ) hour ( -1 ) , and butorphanol loading : 18gkg ( -1 ) ; infusion : 25gkg ( -1 ) hour ( -1 ) ) ( treatment RB , n = 20 ) .


Twenty-one horses underwent dentistry and ophthalmic procedures , while 19 horses underwent only ophthalmologic procedure and buccal examination .


During the procedure , physiologic parameters and occurrence of head/muzzle shaking or twitching and forward movement were recorded .


Whenever sedation was insufficient , additional romifidine ( 20gkg ( -1 ) ) was administered IV .


Recovery time was evaluated by assessing head height above ground .


At the end of the procedure , overall quality of sedation for the procedure was scored by the dentist and anaesthetist using a visual analogue scale .


Statistical analyses used two-way anova or linear mixed models as relevant .


Sedation quality scores as assessed by the anaesthetist were R : median 7.55 , range : 4.9-9 .0 cm , RB : 8.8 , 4.7-10 .0 cm , and by the dentist R : 6.6 , 3.0-8 .2 cm , RB : 7.9 , 6.6-8 .8 cm .


Horses receiving RB showed clinically more effective sedation as demonstrated by fewer poor scores and a tendency to reduced additional drug requirements .


More horses showed forward movement and head shaking in treatment RB than treatment R. Three horses ( two RB , one R ) had symptoms of colic following sedation .


The described protocols provide effective sedation under clinical conditions but for dentistry procedures , the addition of butorphanol is advantageous .


To evaluate the effects of systemic doxycycline on clinical and microbiological parameters of diabetic subjects with chronic periodontitis .


This 9-month multi-center , randomized , parallel , single-blinded study was conducted from different hospitals in Riyadh , Saudi Arabia between April 2010 and December 2010 .


A total of 76 diabetic subjects with chronic periodontitis were randomized into 2 groups : control group ( CG ) received only scaling and root planing ( SRP ) , and the treatment group ( TG ) receiving systemic doxycycline during the reevaluation visit 45 days after the completion of SRP .


Probing pocket depth , clinical attachment level , gingival index , plaque index , and bleeding on probing were collected at baseline , 45 days after SRP , and one , 3 , and 6 months after the use of systemic doxycycline .


Microbiological analysis comprised the detection of Tannerella forsythia ( Tf ) , Aggregatibacter actinomycetemcomitans ( Aa ) , Porphyromonas gingivalis ( Pg ) , and Prevotella intermedia ( Pi ) by polymerase chain reaction method .


Sixty-eight ( 33 CG and 35 TG ) subjects completed the study .


Greater reduction in the population of Tf , Pg , and Pi were observed in TG compared with CG in the first month after the administration of systemic doxycycline .


The TG showed a significant improvement in gingival index scores compared with the CG ( p < 0.05 ) by the end of the first and 6 months after the administration of doxycycline .


Adjunct systemic doxycycline can be associated with a reduction of Tf , Pg , and Pi in the first month after the administration of doxycycline with an improvement in the GI .


This study sought to evaluate the impact of anatomic and procedural variables on the outcome of the unprotected left main coronary artery ( uLMCA ) itself after drug-eluting stent ( DES ) implantation .


There is a controversial debate regarding when and how to perform percutaneous coronary intervention ( PCI ) for an uLMCA stenosis .


This analysis is based on a randomized study of 607 patients undergoing PCI for uLMCA , randomized 1:1 to receive paclitaxel - or sirolimus-eluting stents .


We evaluated the impact of the SYNTAX score , uLMCA anatomy , and stenting technique on in-stent restenosis ( ISR ) , target lesion revascularization ( TLR ) , and the 3-year outcomes .


The 3-year cardiac mortality rate was 5.8 % ; 235 ( 39 % ) patients had a true bifurcation lesion ( TBL ) , and the median SYNTAX score was 27 .


TBL was associated with a higher need for multiple stents ( 72 % vs. 37 % , p < 0.001 ) .


TBL was a significant predictor of ISR ( 23 % vs. 14 % , p = 0.008 ) and for TLR ( 18 % vs. 9 % , p < 0.001 ) .


The need for multiple stents was a predictor of ISR ( 22 % vs. 13 % , p = 0.005 ) and for TLR ( 16 % vs. 9 % , p = 0.005 ) .


Culotte stenting showed better results compared with T-stenting for ISR ( 21 % vs. 56 % , p = 0.02 ) and for TLR ( 15 % vs. 56 % , p < 0.001 ) .


We observed a significant association between uLMCA-TLR and SYNTAX scores ( 9.2 % for scores 22 , 14.9 % for scores 23 to 32 , and 13.0 % for scores 33 , p = 0.008 ) .


PCI of uLMCA lesions with DES is safe and effective out to 3 years .


TBL and multiple stents were independent predictors for ISR .


In the multivariate analysis , independent predictors for TLR were TBL , age , and EuroSCORE ( European System for Cardiac Operative Risk Evaluation ) .


( Drug-Eluting-Stents for Unprotected Left Main Stem Disease [ ISAR-LEFT-MAIN ] ; NCT00133237 ) .


To evaluate the lipid-altering efficacy and safety of ezetimibe monotherapy in young children with heterozygous familial hypercholesterolemia ( HeFH ) or nonfamilial hypercholesterolemia ( nonFH ) .


One hundred thirty-eight children 6-10 years of age with diagnosed HeFH or clinically important nonFH ( low-density lipoprotein cholesterol [ LDL-C ] 160 mg/dL [ 4.1 mmol/L ] ) were enrolled into a multicenter , 12-week , randomized , double-blind , placebo-controlled study .


Following screening/drug washout and a 5-week single-blind placebo-run-in with diet stabilization , subjects were randomized 2:1 to daily ezetimibe 10 mg ( n = 93 ) or placebo ( n = 45 ) for 12 weeks .


Lipid-altering efficacy and safety were assessed in all treated patients .


Overall , mean age was 8.3 years , 57 % were girls , 80 % were white , mean baseline LDL-C was 228 mg/dL ( 5.9 mmol/L ) , and 91 % had HeFH .


After 12 weeks , ezetimibe significantly reduced LDL-C by 27 % after adjustment for placebo ( P < .001 ) and produced significant reductions in total cholesterol ( 21 % ) , nonhigh-density lipoprotein cholesterol ( 26 % ) , and apolipoprotein B ( 20 % ) ( P < .001 for all ) .


LDL-C lowering response in sex , race , baseline lipids , and HeFH/nonFH subgroups was generally consistent with overall study results .


Ezetimibe was well tolerated , with a safety profile similar to studies in older children , adolescents , and adults .


Ezetimibe monotherapy produced clinically relevant reductions in LDL-C and other key lipid variables in young children with primary HeFH or clinically important nonFH , with a favorable safety/tolerability profile .


ClinicalTrials.gov : NCT00867165 .


To examine if 2 weekly sessions of supervised progressive resistance training ( PRT ) in combination with 5 weekly sessions of unsupervised home-based exercise is more effective than 7 weekly sessions of unsupervised home-based exercise in improving leg-extension power of the operated leg 10 weeks after total hip replacement ( THR ) in patients with lower pre-operative function .


A total of 73 patients scheduled for THR were randomised ( 1:1 ) to intervention group ( IG , home based exercise 5 days/week and PRT 2 days/week ) or control group ( CG , home based exercise 7 days/week ) .


The primary endpoint was change in leg extension power at 10 week follow up .


Secondary outcomes were isometric hip muscle strength , sit-to-stand test , stair climb test , 20 m walking speed and patient-reported outcome ( HOOS ) .


Sixty-two completed the trial ( 85 % ) .


Leg extension power increased from baseline to the 10 week follow up in both groups ; mean [ 95 % CI ] IG : 0.29 [ 0.13 ; 0.45 ] and CG : 0.26 [ 0.10 ; 0.42 ] W/kg , with no between-group difference ( primary outcome ) ( P = 0.79 ) .


Maximal walking speed ( P = 0.008 ) and stair climb performance ( P = 0.04 ) improved more in the IG compared to CG , no other between-group differences existed .


In this trial , supervised PRT twice a week in addition to 5 weekly sessions of unsupervised exercise for 10 weeks was not superior to 7 weekly sessions of unsupervised home-based exercise for 10 weeks in improving the primary outcome , leg-extension power of the operated leg , at the primary endpoint 10 weeks after surgery in THR patients with lower pre-operative function .


NCT01214954 .


Candidate predictive biomarkers for epidermal growth factor receptor inhibitors ( EGFRi ) , skin rash and serum proteomic assays , require further qualification to improve EGFRi therapy in non-small cell lung cancer ( NSCLC ) .


In a phase II trial that was closed to accrual because of changes in clinical practice we examined the relationships among candidate biomarkers , quantitative changes in tumor size , progression-free and overall survival .


55 patients with progressive NSCLC after platinum therapy were randomized to receive ( Arm A ) cetuximab , followed by pemetrexed at progression , or ( Arm B ) concurrent cetuximab and pemetrexed .


All received cetuximab monotherapy for the first 14 days .


Pre-treatment serum and weekly rash assessments by standard and EGFRi-induced rash ( EIR ) scales were collected .


43 patients ( 20-Arm A , 23-Arm B ) completed the 14-day run-in .


Median survival was 9.1 months .


Arm B had better median overall ( Arm B = 10.3 [ 95 % CI 7.5 , 16.8 ] ; Arm A = 3.5 [ 2.8 , 11.7 ] months P = 0.046 ) and progression-free survival ( Arm B = 2.3 [ 1.6 , 3.1 ] ; Arm A = 1.6 [ 0.9 , 1.9 ] months P = 0.11 ) .


The EIR scale distributed ratings among 6 rather than 3 categories but ordinal scale rash severity did not predict outcomes .


The serum proteomic classifier and absence of rash after 21 days of cetuximab did .


Absence of rash after 21 days of cetuximab therapy and the serum proteomic classifier , but not ordinal rash severity , were associated with NSCLC outcomes .


Although in a small study , these observations were consistent with results from larger retrospective analyses .


L-Asparaginase is an effective drug in the treatment of childhood acute lymphoblastic leukemia ( ALL ) .


The use of L-asparaginase may be limited by serious adverse events of which allergy is the most frequent .


The objective of this study was to describe the clinical aspects of PEG-asparaginase allergy in children treated according to the Nordic Society of Paediatric Haematology and Oncology ( NOPHO ) ALL2008 protocol .


Children ( 1-17 years ) enrolled in the NOPHO ALL2008 protocol between July 2008 and August 2011 , who developed PEG-asparaginase allergy were identified through the NOPHO ALL2008 toxicity registry .


In the NOPHO ALL2008 protocol , patients are randomized to 8 or 15 doses of intramuscular PEG-asparaginase ( Oncaspar ) 1,000 IU/m ( 2 ) / dose administered at 2 or 6 weeks intervals during a total period of 30 weeks .


( Clinical trials.gov no : NCT00819351 ) .


Of 615 evaluable patients , 79 patients developed clinical PEG-asparaginase allergy ( cumulative risk ; 13.2 % ) and discontinued PEG-asparaginase therapy for that reason .


PEG-asparaginase allergy occurred after a median of two doses ( 75 % range 2-4 , max 14 ) .


In 58 % of PEG-asparaginase hypersensitive patients , the clinical allergic reactions appeared within 2hr after PEG-asparaginase administration and ranged from mild symptoms to systemic anaphylaxis .


Nine patients experienced an anaphylactic reaction within 1hr and 50min from asparaginase administration ; none were fatal .


Four of 68 patients ( 6 % ) who subsequently received Erwinase therapy also reacted allergic to Erwinase .


Clinical allergy to PEG-asparaginase occurred early in treatment , was in general moderate in severity , and mostly developed within 2hr after PEG-asparaginase administration .


The risk of subsequent Erwinase allergic reactions was low .


Abundant evidence on Xpert MTB/RIF accuracy for diagnosing tuberculosis ( TB ) and rifampicin resistance has been produced , yet there are few data on the population benefit of its programmatic use .


We assessed whether the implementation of Xpert MTB/RIF in routine conditions would ( 1 ) increase the notification rate of laboratory-confirmed pulmonary TB to the national notification system and ( 2 ) reduce the time to TB treatment initiation ( primary endpoints ) .


We conducted a stepped-wedge cluster-randomized trial from 4 February to 4 October 2012 in 14 primary care laboratories in two Brazilian cities .


Diagnostic specimens were included for 11,705 baseline ( smear microscopy ) and 12,522 intervention ( Xpert MTB/RIF ) patients presumed to have TB .


Single-sputum-sample Xpert MTB/RIF replaced two-sputum-sample smear microscopy for routine diagnosis of pulmonary TB .


In total , 1,137 ( 9.7 % ) tests in the baseline arm and 1,777 ( 14.2 % ) in the intervention arm were positive ( p < 0.001 ) , resulting in an increased bacteriologically confirmed notification rate of 59 % ( 95 % CI = 31 % , 88 % ) .


However , the overall notification rate did not increase ( 15 % , 95 % CI = -6 % , 37 % ) , and we observed no change in the notification rate for those without a test result ( -3 % , 95 % CI = -37 % , 30 % ) .


Median time to treatment decreased from 11.4 d ( interquartile range [ IQR ] = 8.5-14 .5 ) to 8.1 d ( IQR = 5.4-9 .3 ) ( p = 0.04 ) , although not among confirmed cases ( median 7.5 [ IQR = 4.9-10 .0 ] versus 7.3 [ IQR = 3.4-9 .0 ] , p = 0.51 ) .


Prevalence of rifampicin resistance detected by Xpert was 3.3 % ( 95 % CI = 2.4 % , 4.3 % ) among new patients and 7.4 % ( 95 % CI = 4.3 % , 11.7 % ) among retreatment patients , with a 98 % ( 95 % CI = 87 % , 99 % ) positive predictive value compared to phenotypic drug susceptibility testing .


Missing data in the information systems may have biased our primary endpoints .


However , sensitivity analyses assessing the effects of missing data did not affect our results .


Replacing smear microscopy with Xpert MTB/RIF in Brazil increased confirmation of pulmonary TB .


An additional benefit was the accurate detection of rifampicin resistance .


However , no increase on overall notification rates was observed , possibly because of high rates of empirical TB treatment .


ClinicalTrials.gov NCT01363765 .


Please see later in the article for the Editors ' Summary .


To evaluate the clinical effect of endotracheal lavage with porcine pulmonary surfactant ( PS ) in term neonates with severe meconium aspiration syndrome ( MAS ) .


A total of 136 full-term infants with severe MAS who were admitted to the neonatal intensive care unit between January 2010 and June 2013 were randomly and equally divided into PS lavage and PS injection groups .


In the PS lavage group , patients were treated with endotracheal lavage using 3-5 mL of diluted PS ( 12 mg/mL ) each time , and the PS injection group was given PS by intratracheal injection at the first dose of 200 mg/kg .


Blood gas , oxygenation index ( OI ) , and PaO2/FiO2 ( P/F ) of the two groups were evaluated before and 2 , 12 , 24 , and 48 hours after the treatment , and the duration of mechanical ventilation , complication rate , and cure rate were compared between the two groups .


Compared with the PS injection group , the PS lavage group had significantly higher PaO2 and P/F ration and significantly lower PaCO2 and OI at 12 , 24 , and 48 hours post-treatment ( P < 0.01 ) , a significantly shorter duration of mechanical ventilation ( P < 0.01 ) , a significantly smaller amount of PS ( P < 0.01 ) , a significantly lower complication rate ( P < 0.05 ) , and a significantly higher cure rate ( 97 % vs 88 % ; P < 0.05 ) .


Compared with the intratracheal injection of PS , endotracheal lavage with diluted PS in term neonates with severe MAS can increase ventilation and oxygenation efficiency , shorten the duration of mechanical ventilation , reduce the complication rate , and increase the cure rate , indicating that this method is a safe and effective therapeutic strategy .


To determine whether a combination modified-live bovine respiratory syncytial virus ( BRSV ) vaccine could stimulate protective immunity in young BRSV-seropositive calves following intranasal administration and determine the duration of clinical immunity .


Controlled challenge study .


Animals-84 dairy calves ( 3 to 11 days old ) .


Responses to BRSV challenge of seronegative calves vaccinated under licensing trial conditions were compared with those of seropositive calves 2 times after vaccination .


In experiment 1 , young BRSV-seronegative calves were vaccinated intranasally with a minimum immunizing dose of BRSV and challenged with BRSV approximately 7 weeks later .


In experiments 2 and 3 , young BRSV-seropositive calves were vaccinated intranasally with a commercially available combination modified-live virus vaccine containing the commercial dose of the BRSV fraction and challenged with BRSV 9 weeks or approximately 14 weeks later , respectively .


In experiments 1 and 2 , BRSV-vaccinated calves had significantly higher Pao2 , significantly fewer lung lesions , and significantly lower mortality rate than did unvaccinated calves subsequent to BRSV challenge .


In contrast , in experiment 3 , there were no differences in Pao2 , lung lesions , or mortality rate between vaccinated and control calves after BRSV challenge approximately 14 weeks after vaccination .


Protected calves in experiment 1 consistently had significant anamnestic mucosal and systemic antibody responses after challenge , whereas in experiments 2 and 3 , antibody responses after challenge were more variable .


A combination BRSV vaccine administered intranasally to young calves induced protective immunity in the presence of maternal antibodies .


The duration of immune responses induced by intranasal vaccination was short ( 4 months ) .


Boosting immunity iatrogenically , or by natural exposure , is probably required to obtain optimal responses to neonatal intranasal vaccination .


To describe female lumbar spine motion and posture characteristics during coitus and compare these characteristics across five common coital positions .


Exacerbation of low back pain during coital movements and positions is a prevalent issue reported by female low back pain ( LBP ) patients .


To address this problem , the first study to examine lumbar spine biomechanics during coitus was conducted .


Ten healthy males and females performed coitus in the following pre-selected positions and variations : QUADRUPED ( fQUAD1 and fQUAD2 where the female is supporting her upper body with her elbows and hands , respectively ) , MISSIONARY ( fMISS1 and fMISS2 where the female is minimally and more flexed at the hips and knees , respectively ) , and SIDELYING .


An electromagnetic motion capture system was used to measure three-dimensional lumbar spine angles that were normalized to maximum active range of motion-a transmitter and receiver were affixed to the skin overlying the lateral aspect of the pelvis and the spinous process of the twelfth thoracic vertebra , respectively .


To determine if each coital position had distinct spine kinematic profiles ( i.e. , amplitude probability distribution function and total range of lumbar spine motion ) , separate univariate general linear models followed by Tukey 's honestly significant difference post hoc analysis were used .


The presentation of coital positions was randomized .


Female lumbar spine movement varied depending on the coital position ; both variations of QUADRUPED , fQUAD1 and fQUAD2 , were found to use a significantly greater range of spine motion than fMISS2 ( p = 0.017 and p = 0.042 , respectively ) .


With the exception of both variations of MISSIONARY , fMISS1 and fMISS2 , the majority of the range of motion used was in extension .


These findings are most pertinent to patients with LBP that is exacerbated by motions or postures .


Based on the spine kinematic profiles of each position , the least-to-most recommended positions for a female flexion-intolerant patient are : fMISS2 , fMISS1 , fQUAD1 , fSIDE , and fQUAD2 .


These recommendations would be contraindicated for the extension-intolerant patient .


The findings provided here may guide the clinician 's specific recommendations , including alternative coital positions and/or movement patterns or suggesting a lumbar support , depending on the female LBP patient 's specific motion and posture intolerances .


Tremor in Charcot-Marie-Tooth disease ( CMT ) can be disabling .


Cerebellar abnormalities are thought to underpin neuropathic tremor .


Here , we aim to clarify the potential role of the cerebellum in CMT tremor .


We assessed prevalence of tremor by questionnaire in 84 patients with CMT .


Of those , 23 patients with CMT with and without arm tremor and healthy controls underwent a clinical assessment , classical eyeblink conditioning , electro-oculography , visuomotor adaptation test , tremor recording with surface EMG and accelerometry , and retrospective correlation with nerve conduction studies to investigate the possible mechanisms of tremor generation .


The prevalence study revealed tremor in 21 % of patients and in 42 % of those it caused impairment of function .


Tremor recordings revealed a mild-to-moderate amplitude tremor with a weight load-invariant 7.7 Hz frequency component .


Performance on classical eyeblink conditioning , visuomotor adaptation and electro-oculography were no different between tremulous and non-tremulous patients and healthy controls .


These results argue against a prominent role for an abnormal cerebellum in tremor generation in the patients studied with CMT .


Rather , our results suggest an enhancement of the central neurogenic component of physiological tremor as a possible mechanism for tremor in the patients studied .


This study is the first to propose differing pathogenic mechanisms for subtypes of neuropathic tremor .


The effect of dexmedetomidine on evoked potentials ( EPs ) has not been elucidated .


We aimed to investigate the effect of dexmedetomidine on somatosensory , motor , and visual EPs .


After IRB approval , 40 adult patients scheduled for elective spine surgery using total IV anesthesia with propofol and remifentanil were randomly assigned to receive either dexmedetomidine ( n = 20 ) or placebo ( n = 20 ) in a double-blind , placebo-controlled trial .


After obtaining informed consent , positioning , and baseline EPs recording , patients were randomly assigned to either IV dexmedetomidine 0.6 g/kg infused over 10 minutes , followed by 0.6 g/kg/h , or a corresponding volume of IV normal saline ( placebo ) .


EP measures at 60 30 minutes after initiation of study drug were defined as T1 and at 150 30 minutes were defined as T2 .


Changes from baseline to T1 ( primary end point ) and from baseline to T2 ( secondary end point ) in EP latencies ( milliseconds ) and amplitudes ( microvolts ) were compared between groups .


Data presented as mean SD ( 95 % confidence interval ) .


Data from 40 patients ( dexmedetomidine : n = 20 ; age , 54 3 years ; 10 males ; placebo : n = 20 ; age , 52 2 years ; 5 males ) were analyzed .


There was no difference between dexmedetomidine versus placebo groups in primary end points : change of somatosensory EPs at T1 , latency : 0.01 1.3 ( -0.64 , 0.65 ) vs 0.01 1.3 ( -0.64 , 0.65 ) , P = 0.43 ( -1.24 , 0.45 ) ; amplitude : 0.03 0.14 ( -0.06 , 0.02 ) vs -0.01 0.13 ( -0.07 , 0.05 ) , P = 0.76 ( -0.074 , 0.1 ) ; motor EPs amplitude at T1 : 65.1 194.8 ( -35 , 165 ; n = 18 ) vs 109.2 241.4 ( -24 , 243 ; n = 16 ) , P = 0.57 ( -113.5 , 241.57 ) ; visual EPs at T1 ( right eye ) , amplitude : 2.3 3.6 ( -0.4 , 5.1 ; n = 11 ) vs 0.3 6.0 ( -3.3 , 3.9 ; n = 16 ) , P = 0.38 ( -6.7 , 2.6 ) ; latency N1 : 2.3 3.6 ( -0.4 , 5.1 ) vs 0.3 6.0 ( -3.3 , 3.9 ) , P = 0.38 ( -6.7 , 2.6 ) ; latency P1 : -1.6 13.4 ( -11.9 , 8.7 ) vs -1.4 8.1 ( -6.3 , 3.5 ) , P = 0.97 ( -9.3 , 9.7 ) or secondary end points .


There were no differences between right and left visual EPs either at T1 or at T2 .


In clinically relevant doses , dexmedetomidine as an adjunct to total IV anesthesia does not seem to alter EPs and therefore can be safely used during surgeries requiring monitoring of EPs .


Teaching in the presence of the patient is an acceptable model in medical settings .


Questions have been raised about the appropriateness of this type of teaching ( exam room teaching ) with patients with mental health issues .


This prospective randomized controlled study examined outpatient exam room teaching in a psychiatric setting .


In 2011-2012 , patients in the adult outpatient psychiatry clinic at the University of Iowa were randomized to have faculty-learner presentations either in the presence of the patient or in the conference room .


Teaching encounters were timed and faculty , learners , and patients completed post encounter surveys .


Participation included 126 patients , nine faculty , and 16 residents .


Comparison of patient encounters randomized to exam room ( n = 58 ) or conference room ( n = 64 ) demonstrated that exam room teaching was roughly twice as time efficient as conference room teaching ( p .0001 ) .


Patients expressed a preference for exam room teaching during future visits ( p .003 ) for those patients who experienced exam room teaching during the study .


Faculty were generally comfortable with exam room teaching and felt it had some advantages for patient decision making .


Learners felt they had to choose their words more carefully in exam room teaching and expressed some concerns about depth of teaching .


Once exposed to exam room teaching , this model is acceptable and feasible to faculty , learners , and patients in a psychiatry clinic setting .


Over 50 % of patients with head and neck squamous cell carcinoma ( HNSCC ) present with locoregionally advanced disease .


Those at intermediate-to-high risk of recurrence after definitive therapy exhibit advanced disease based on tumour size or lymph node involvement , non-oropharynx primary sites , human papillomavirus ( HPV ) - negative oropharyngeal cancer , or HPV-positive oropharynx cancer with smoking history ( > 10-pack-years ) .


Non-surgical approaches include concurrent chemoradiotherapy , induction chemotherapy followed by definitive radiotherapy or chemoradiotherapy , or radiotherapy alone .


Following locoregional therapies ( including surgical salvage of residual cervical nodes ) , no standard intervention exists .


Overexpression of epidermal growth factor receptor ( EGFR ) , an ErbB family member , is associated with poor prognosis in HNSCC .


EGFR-targeted cetuximab is the only targeted therapy that impacts overall survival and is approved for HNSCC in the USA or Europe .


However , resistance often occurs , and new approaches , such as targeting multiple ErbB family members , may be required .


Afatinib , an irreversible ErbB family blocker , demonstrated antiproliferative activity in preclinical models and comparable clinical efficacy with cetuximab in a randomized phase II trial in recurrent or metastatic HNSCC .


LUX-Head & Neck 2 , a phase III study , will assess adjuvant afatinib versus placebo following chemoradiotherapy in primary unresected locoregionally advanced intermediate-to-high-risk HNSCC .


Patients with primary unresected locoregionally advanced HNSCC , in good clinical condition with unfavourable risk of recurrence , and no evidence of disease after chemoradiotherapy will be randomized 2:1 to oral once-daily afatinib ( 40 mg starting dose ) or placebo .


As HPV status will not be determined for eligibility , unfavourable risk is defined as non-oropharynx primary site or oropharynx cancer in patients with a smoking history ( > 10 pack-years ) .


Treatment will continue for 18 months or until recurrence or unacceptable adverse events occur .


The primary endpoint measure is duration of disease-free survival ; secondary endpoint measures are disease-free survival rate at 2 years , overall survival , health-related quality of life and safety .


Given the unmet need in the adjuvant treatment of intermediate-to-high-risk HNSCC patients , it is expected that LUX-Head & Neck 2 will provide new insights into treatment in this setting and might demonstrate the ability of afatinib to significantly improve disease-free survival , compared with placebo .


ClinicalTrials.gov NCT01345669 .


Topical tretinoin is considered the gold standard to treat photoaged skin , but it is associated with side effects and only available upon prescription .


To compare the efficacy , tolerance , and perception of a fixed proprietary combination ( Retinol 0.2 % / LR2412 2 % ) vs. tretinoin 0.025 % cream in women with photoaged skin .


In this randomized , parallel , double-blind , controlled clinical study , women applied to the entire face for 3months in the morning a SPF 50 sunscreen and in the evening either the association of Retinol 0.2 % / LR2412 2 % or tretinoin 0.025 % .


Clinical and instrumental parameters were assessed at days 0 , 28 , 56 , and 84 .


Subject perception of the efficacy , tolerance and cosmeticity of the tested products were assessed at days 28 , 56 , and 84 .


A total of 120 women ( 60 to Retinol 0.2 % / LR2412 2 % cream and 60 to tretinoin 0.025 % cream ) were included in the study .


Both products improved considerably wrinkles , mottled pigmentation , pores , and global photodamage .


No statistically significant differences were noted between Retinol 0.2 % / LR2412 2 % cream and tretinoin 0.025 % cream .


Adverse effects were mostly graded mild .


Overall , Retinol 0.2 % / LR2412 2 % cream was better tolerated than tretinoin 0.025 % cream .


At all visits , subject perception of the association of Retinol 0.2 % / LR2412 2 % was either comparable to or better than tretinoin 0.025 % cream .


The treatment outcome of Retinol 0.2 % / LR2412 2 % cream does not differ from the one of tretinoin 0.025 % cream .


Clinical results were not statistically different .


Furthermore , Retinol 0.2 % / LR2412 2 % cream is better tolerated and better perceived by women used to rejuvenation procedures .


Central blood pressure ( BP ) , an important measure of cardiovascular risk , has been shown to be effectively reduced by calcium channel blockade with amlodipine ( AML ) plus renin-angiotensin system blockade by the angiotensin-converting enzyme inhibitor , perindopril ( PER ) .


The aim of the SEVITENSION study was to compare the central effects of PER/AML against renin-angiotensin system blockade with the angiotensin II receptor blocker olmesartan ( OLM ) plus AML .


In this multicenter , parallel group , non-inferiority study , patients received AML 10 mg during a 2 - to 4-week run-in before randomization to 24 weeks of double-blind treatment with the fixed-dose combination of OLM/AML 40/10 mg or PER/AML 8/10 mg .


Hydrochlorothiazide was added at Weeks 4 , 8 , or 12 in patients with inadequate BP control .


The primary efficacy variable was the absolute change in central systolic BP ( CSBP ) from baseline to the final examination , measured by radial artery applanation tonometry and analyzed by parametric analysis of covariance .