The perspective of the analysis was that of the payer , specifically the Centers for Medicare and Medicaid Services .


No cost discounting was performed because of the short duration of the study .


The study consisted of 26 patients , with 13 in each group .


In the ECM group , 10 wounds closed ( 77 % ) , with an average closure time of 36 days ; 11 wounds closed in the HFDS group ( 85 % ) , with an average closure time of 41 days .


There was no significant difference between these results ( p = 0.73 ) .


Over 12 weeks , the expected cost per DFU was $ 2522 ( 1634 ) for ECM and $ 3889 ( 2524 ) for HFDS .


Patients treated with HFDS incurred total treatment costs that were approximately 54 % higher than those treated with ECM .


Sensitivity analyses revealed that the total cost of care for two applications of HFDS was more costly than eight applications of ECM by approximately $ 500 ( 325 ) .


In patients with DFU , ECM yielded similar clinical outcomes to HFDS but at a lower cost .


Health-care providers should consider ECM as a cost-saving alternative to HFDS .


A.M. Gilligan , and C.R. Waycaster , are employees of Smith & Nephew Inc. . .


This study was funded by Smith & Nephew Inc. . .


A.L. Landsman , reports no conflicts of interest .


To better understand the relationship between efficacy and perampanel dose , integrated actual ( last ) dose data from three phase III trials and an extension study ( blinded Conversion Period ; open-label Maintenance Period ) were analyzed .


Seizure frequency data were analyzed in patients who were randomized to and completed the 13-week Maintenance Period of the phase III studies on perampanel 8mg , and who received an actual ( last ) dose of 12mg during ( 1 ) the extension 16-week blinded Conversion Period or ( 2 ) weeks 1-13 of the extension Maintenance Period .


Due to a treatment-by-region interaction ( p = 0.042 ) , analyses excluded patients from the Latin America region ( n = 162/1 ,480 ; 10.9 % of the treated cohort ) .


Of 372 patients randomized to 8mg in the phase III studies , 273 completed the Maintenance Period at 8mg and 267 entered the extension study .


In patients who then had an actual ( last ) dose of 12mg during the extension blinded Conversion Period ( n = 217 ) , median percent change in seizure frequency per 28days improved from -32.4 % ( 8mg , phase III Maintenance Period ) to -44.2 % ( 12mg , extension blinded Conversion Period ) ; 50 % responder rates increased slightly from 37.3 % to 42.9 % .


In patients who completed the phase III studies on 8mg and had an actual ( last ) dose of 12mg during weeks 1-13 of the extension Maintenance Period ( n = 181 ) , median percent change in seizure frequency per 28days improved from -34.1 % ( phase III Maintenance Period ) to -46.0 % ( weeks 1-13 extension Maintenance Period ) ; 50 % responder rates were 39.2 % and 46.4 % .


Seizure control remained substantially unchanged in patients who completed the phase III studies at 12mg and continued on that dose during the extension .


Increasing perampanel dose from 8 to 12mg can produce additional benefits in seizure control in at least some patients who tolerate the higher dose .


Individualizing antiplatelet therapy after platelet function testing did not improve outcome after coronary stenting in the Assessment by a Double Randomization of a Conventional Antiplatelet Strategy Versus a Monitoring-Guided Strategy for Drug-Eluting Stent Implantation and of Treatment Interruption Versus Continuation One Year After Stenting ( ARCTIC ) study .


Whether results are different during the phase of secondary prevention starting after hospital discharge , when periprocedural events have been excluded , is unknown .


In ARCTIC , 2440 patients were randomized before coronary stenting to a strategy of platelet function monitoring ( VerifyNow P2Y12/aspirin point-of-care assay ) with drug adjustment in suboptimal responders to antiplatelet therapy or to a conventional strategy without monitoring and without drug or dose changes .


We performed a landmark analysis starting at the time of hospital discharge evaluating the primary end point of death , myocardial infarction , stent thrombosis , stroke , or urgent revascularization through 1 year .


After discharge , the primary end point occurred in 8.6 % of patients in the monitoring arm and 7.9 % in the conventional arm ( hazard ratio , 1.105 ; 95 % confidence interval , 0.835-1 .461 ; P = 0.48 ) .


Stent thrombosis or urgent revascularization occurred in 4.4 % and 4.5 % in the monitoring and conventional arms , respectively ( P = 0.99 ) .


There was no difference for any of the other ischemic end points .


Major bleeding event rates were 1.8 % in the monitoring arm and 2.8 % in the conventional arm ( P = 0.11 ) , whereas major or minor bleeding event rates were 2.3 % and 3.4 % , respectively ( P = 0.10 ) .


Detection of platelet hyper-reactivity by platelet function testing in patients undergoing coronary stenting with further therapeutic adjustment does not reduce ischemic recurrences after intervention .


On-treatment platelet hyperreactivity can not be considered as a risk factor requiring intervention for secondary prevention after percutaneous coronary revascularization .


http://www.clinicaltrials.gov .


Unique identifier : NCT00827411 .


Age-related sleep changes have been associated with altered hypothalamic-pituitary-adrenal axis reactivity and impaired feedback inhibition at the glucocorticoid ( GR ) and mineralocorticoid ( MR ) receptor level .


To further investigate the specific role of this binary receptor system in the elderly , sleep electroencephalogram ( EEG ) effects of the MR antagonist spironolactone and GR antagonist mifepristone in old-aged men were compared in this pilot study .


Old-aged healthy men ( n = 6 , 65-91 years ) were treated on three occasions in a single-blinded design in random order with mifepristone , spironolactone and placebo , respectively , and nocturnal sleep EEG was recorded .


Mifepristone led to increased wake time , decreased stage 2 and rapid eye movement ( REM ) sleep and prolonged REM sleep latency in the first half of the night , whereas spironolactone had no considerable effects on sleep EEG .


GR antagonism can potentiate age-related sleep pattern alterations and further support the role of impaired GR signaling in age-related changes in sleep architecture .


Obesity often occurs co-morbid with chronic , non-cancer pain .


While behavioral treatments have proved effective for pain management and weight loss independently , integrated interventions are lacking .


The study Simultaneously Targeting Obesity and Pain ( STOP ) is a prospective , pragmatic , randomized controlled trial that aims to determine whether overweight/obese individuals with chronic pain who are randomized to receive an integrated treatment Simultaneously Targeting Obesity and Pain ( STOP ) will show more weight loss and greater reduction in pain intensity over a 6-month period and greater maintenance at 12months than those who receive standard care behavioral weight loss or standard care behavioral pain management .


We hypothesize that individuals randomized to receive the STOP treatment will demonstrate improved weight loss , pain reduction , and maintenance compared to standard care treatment approaches .


Adults aged18 with a body mass index25 and who report persistent pain ( 4 out of 0-10 for > 6months ) will be recruited for treatment at the Health Behavior Research Lab at the University of the Sciences .


After baseline assessments and goal setting , participants will be randomized to receive one of three treatments .


Participants will receive eleven treatment sessions delivered during 1hour , weekly individual meetings with a clinic therapist .


Follow-up will occur at 3 , 6 and 12-month time points ; assessments will include measures of weight and pain intensity ( primary outcomes ) .


A mixed-method approach to evaluating study outcomes will include individual interviews with participants about their treatment experience .


These interviews will be led by a research staffer who was not involved in study intervention or assessment using a semi-structured discussion guide .


This study fills an important gap in intervention research , evaluating best-practices for behavioral management of a highly prevalent co-morbidity that has sub-optimal outcomes with currently-implemented approaches .


STOP 's pragmatic focus builds upon treatments already in use in clinical practice .


Should STOP be found efficacious in achieving the dual outcomes of pain management and weight loss , such an approach could be integrated into practice with minimal additional cost or training .


Clinical Trials.gov NCT02100995 Date of Registration : March 2014 .


To compare the visual outcome of microincision ( 2.2 mm ) with standard ( 2.75 mm ) corneal incision phacoemulsification .


In this prospective , randomized comparative study , patients with senile cataract and less than 1 diopter ( D ) of astigmatism were divided into two groups .


Group 1 included patients undergoing phacoemulsification with 2.2 mm clear corneal incision and group 2 included those undergoing phacoemulsification with 2.75 mm incision .


The steep axis measured on keratometry was marked preoperatively .


Phacoemulsification was performed through clear corneal incision on this steep axis .


Assessment of visual acuity ( distance and near ) , keratometry , keratometric cylinder , contrast sensitivity by Functional Acuity Contrast Test , and surgically induced astigmatism ( SIA ) was performed at 1 day , 1 week , and 1 , 3 , and 6 months .


Fifty eyes of 50 patients were included in the study ( 29 were male ) .


There were 25 patients in each group .


The mean ( SD ) SIA calculated by vector analysis method ( Holladay-Cravy-Koch ) using keratometry value , at the end of 6 months , was 0.54 ( 0.18 ) D and 0.58 ( 0.14 ) D in groups 1 and 2 , respectively ( p = 0.27 ) .


No significant differences were found in the distance and near uncorrected visual acuity , mean keratometry , keratometric cylinder , contrast sensitivity , and SIA at any follow-up visit between two groups .


In patients with less than 1 D astigmatism undergoing phacoemulsification , both 2.2-mm and 2.75-mm clear corneal incisions result in similar postoperative visual outcome in terms of SIA , keratometry , and contrast sensitivity .


To evaluate the safety and efficacy of the novel tenofovir prodrug , tenofovir alafenamide ( TAF ) , as part of the first protease inhibitor-based single-tablet regimen ( STR ) for initial treatment of HIV-1 infection .


Antiretroviral therapy ( ART ) - naive adults with estimated glomerular filtration rate 70 mL/min were randomized 2:1 to receive the darunavir/cobicistat/emtricitabine / tenofovir alafenamide ( D/C/F / TAF ) STR ( TAF : N = 103 ) or darunavir + cobicistat + emtricitabine/tenofovir disoproxil fumarate ( TDF : N = 50 ) once daily with matched placebos for 48 weeks .


At week 24 , viral suppression ( HIV-1 RNA < 50 copies/mL ) rates were similar ( TAF 74.8 % vs. TDF 74.0 % ) .


At week 48 , rates were TAF 76.7 % vs. TDF 84.0 % ; the difference was driven by higher rate of discontinuations in TAF ( 6.8 % ) vs. TDF ( 2 % ) .


Among those with virologic failure , none developed resistance .


Most adverse events were of mild/moderate severity .


The mean change in serum creatinine from baseline at week 48 was 0.06 mg/dL ( 95 % confidence interval : 0.04 to 0.08 ) for TAF vs. 0.09 mg/dL ( 95 % confidence interval : 0.05 to 0.14 ) for TDF ( P = 0.053 ) .


The % change in retinol binding protein/Cr ratio was +9 ( TAF ) vs. +54 ( TDF ) , P = 0.003 ; the % change in urine -2 microglobulin/Cr ratio was -42.0 ( TAF ) vs. +2.3 ( TDF ) , P = 0.002 .


The % change in hip bone mineral density ( BMD ) was -0.84 ( TAF ) vs. -3.82 ( TDF ) , P < 0.001 and in spine BMD was -1.57 ( TAF ) vs. -3.62 ( TDF ) , P = 0.003 .


There were no fractures in either group .


The TAF arm had significantly improved renal and bone safety parameters : less proteinuria and less change in hip and spine BMD , consistent with results from a similarly designed study of the elvitegravir/C/F / TAF STR .


This D/C/F / TAF STR offers a promising option for initial HIV treatment , with the high barrier to resistance of darunavir , and the potential for improved long-term renal and bone safety with TAF .


Therapeutic hypothermia is recommended for comatose adults after witnessed out-of-hospital cardiac arrest , but data about this intervention in children are limited .


We conducted this trial of two targeted temperature interventions at 38 children 's hospitals involving children who remained unconscious after out-of-hospital cardiac arrest .


Within 6 hours after the return of circulation , comatose patients who were older than 2 days and younger than 18 years of age were randomly assigned to therapeutic hypothermia ( target temperature , 33.0 C ) or therapeutic normothermia ( target temperature , 36.8 C ) .


The primary efficacy outcome , survival at 12 months after cardiac arrest with a Vineland Adaptive Behavior Scales , second edition ( VABS-II ) , score of 70 or higher ( on a scale from 20 to 160 , with higher scores indicating better function ) , was evaluated among patients with a VABS-II score of at least 70 before cardiac arrest .


A total of 295 patients underwent randomization .


Among the 260 patients with data that could be evaluated and who had a VABS-II score of at least 70 before cardiac arrest , there was no significant difference in the primary outcome between the hypothermia group and the normothermia group ( 20 % vs. 12 % ; relative likelihood , 1.54 ; 95 % confidence interval [ CI ] , 0.86 to 2.76 ; P = 0.14 ) .


Among all the patients with data that could be evaluated , the change in the VABS-II score from baseline to 12 months was not significantly different ( P = 0.13 ) and 1-year survival was similar ( 38 % in the hypothermia group vs. 29 % in the normothermia group ; relative likelihood , 1.29 ; 95 % CI , 0.93 to 1.79 ; P = 0.13 ) .


The groups had similar incidences of infection and serious arrhythmias , as well as similar use of blood products and 28-day mortality .


In comatose children who survived out-of-hospital cardiac arrest , therapeutic hypothermia , as compared with therapeutic normothermia , did not confer a significant benefit in survival with a good functional outcome at 1 year .


( Funded by the National Heart , Lung , and Blood Institute and others ; THAPCA-OH ClinicalTrials.gov number , NCT00878644 . )


Many patients with lung cancer are deconditioned with poor physical fitness .


Lung resection reduces physical fitness further , impairing the patient 's ability to function in daily life .


We conducted a single-blind randomised controlled trial of high-intensity endurance and strength training ( 60min , three times a week , 20weeks ) , starting 5-7weeks after surgery .


The control group received standard postoperative care .


The primary outcome was the change in peak oxygen uptake measured directly during walking until exhaustion .


Other outcomes included changes in pulmonary function , muscular strength by one-repetition maximum ( 1RM ) , total muscle mass measured by dual energy X-ray absorptiometry , daily physical functioning and quality of life ( QoL ) .


The intention-to-treat analysis of the 61 randomised patients showed that the exercise group had a greater increase in peak oxygen uptake ( 3.4 mL/kg/min between-group difference , p = 0.002 ) , carbon monoxide transfer factor ( Tlco ) ( 5.2 % predicted , p = 0.007 ) , 1RM leg press ( 29.5 kg , p < 0.001 ) , chair stand ( 2.1 times p < 0.001 ) , stair run ( 4.3 steps , p = 0.002 ) and total muscle mass ( 1.36 kg , p = 0.012 ) compared with the controls .


The meanSD QoL ( SF-36 ) physical component summary score was 51.85.5 and 43.311.3 ( p = 0.006 ) , and the mental component summary score was 55.55.3 and 46.614.0 ( p = 0.015 ) in the exercise and control groups , respectively .


In patients recently operated for lung cancer , high-intensity endurance and strength training was well tolerated and induced clinically significant improvements in peak oxygen uptake , Tlco , muscular strength , total muscle mass , functional fitness and QoL .


This study may provide a basis for exercise therapy after lung cancer surgery .


NCT01748981 .


To investigate the efficacy and mechanisms of Bawei Xilei Powder ( BXP ) in treating ulcerative colitis ( UC ) .


Totally 103 patients with left hemicolon mild to moderate UC in the active phase at the outpatient clinics of West China Hospital from June 2009 to October 2010 were randomly assigned to the treatment group ( 55 cases ) and the control group ( 48 cases ) .


Patients in the treatment group were treated with BXP ( adding 1 g in 60 mL worm boiled water ) and those in the control group received by 50 mg/60 mL hydrocortisone edema solution ( once every evening before sleep ) .


The therapeutic course for all was 4 weeks .


The disease activity degree ( Mayo scoring ) , endoscopic , and histologic manifestations were compared between post-and pre-treatment in the two groups .


The expression of toll-like receptor-4 ( TLR4 ) , nuclear factor-kappaB ( NF-kappaB ) , and Occludin were detected .


The clinical remission rate and the response rate in the treatment group were 78.2 % and 89.1 % respectively , higher than those of the control group ( 58.3 % and 72.9 % , P < 0.05 ) .


The endoscopically mucosal healing rate was 50.9 % in the treatment group and 31.3 % in the control group ( P < 0.05 ) .


The histological remission rate and the effective rate in the treatment group were 32.7 % and 65.5 % respectively , but higher than those of the control group ( 27.1 % and 58.3 % , P > 0.05 ) .


The rate of adverse events was 3.8 % in the treatment ( occurred in 2 cases ) and 4.3 % in the control group ( occurred in 2 cases , P > 0.05 ) .


Compared with pre-treatment , the expression of TLR4 and NF-kappaB p65 significantly decreased ( P < 0.05 ) , while the expression of Occludin significantly increased ( P < 0.05 ) .


BXP was effective and safe in patients with active mild to moderate UC .


Its effects might be involved in regulating the expression of inflammatory factors and enhancing mucosa barrier functions .


ulcerative colitis ; Bawei Xilei Powder ; enema therapy


To evaluate the efficacy of oral sucrose combined with non-nutritive sucking for reducing pain associated with retinopathy of prematurity screening .


This was a randomised controlled study of 64 infants undergoing eye examination for retinopathy of prematurity screening .


Topical anaesthetic ( Proparacaine ; Alcaine ( ) drop 0.5 % : ALCON CANADA Inc. , Mississauga , Canada ) was applied 30 sec before the eye examination in all infants .


The infants in intervention group ( Group 1 , n = 32 ) received 0.5 mL/kg of 24 % sucrose with a pacifier .


The control group ( Group 2 , n = 32 ) received 0.5 mL/kg of sterile water with a pacifier .


The groups had similar gestational ages ( 28.5 2.8 weeks ) , mean birthweight ( 1304 466 g ) or corrected gestational age ( 35.4 3.7 weeks ) at examination .


The intervention group had a significantly lower mean Premature Infant Pain Profile score during examination of the first eye , following insertion of the speculum ( Group 1:13.7 2.1 vs. Group 2:16.4 1.8 , p = 0.001 ) .


Although sucrose combined with non-nutritive sucking modestly reduces pain scores during eye examinations , there is need to further studies to explore significant pain relief for infants undergoing retinopathy of prematurity screening .


High resolution three-dimensional ( 3D ) late gadolinium enhancement ( LGE ) imaging is performed with single R-wave gating to minimize lengthy acquisition durations .


In patients with atrial fibrillation ( AF ) , heart rate variability results in variable magnetization recovery between sequence repeats , and image quality is often poor .


In this study , we implemented and tested a dynamic inversion time ( dynamic-TI ) scheme designed to reduce sequence sensitivity to heart rate variations .


An inversion-prepared 3D segmented gradient echo sequence was modified so that the TI varied automatically from beat-to-beat ( dynamic-TI ) based on the time since the last sequence repeat .


3D LGE acquisitions were performed in 17 patients prior to radio frequency ablation of persistent AF both with and without dynamic-TI .


Qualitative image quality scores , blood signal-to-ghosting ratios ( SGRs ) .


and blood-myocardium contrast-to-ghosting ratios ( CGRs ) were compared .


Image quality scores were higher with dynamic-TI than without dynamic-TI ( 2.2 0.9 vs. 1.8 1.1 , P = 0.008 ) , as were blood-myocardium CGRs ( 13.8 7.6 vs. 8.3 6.1 , P = 0.003 ) and blood SGRs ( 19.6 8.5 vs. 13.1 8.0 , P = 0.003 ) .


The dynamic-TI algorithm improves image quality of 3D LGE imaging in this difficult patient population by reducing the sequence sensitivity to RR interval variations


Taking weight-loss supplements may create illusion of protection against weight gain and thereby loosen subsequent dietary self-control .


The current study examined whether taking weight-loss supplement would increase food intake and further tested whether positive attitudes toward supplements would increase susceptibility to overeating .


Participants were randomly assigned to take either a known placebo or a purported weight loss supplement ( actually , the same placebo ) .


After supplement provision , participants ' actual food consumption at a reward buffet lunch was recorded .


Compared with controls , participants receiving a purported weight loss supplement ate more food at the reward buffet .


Perceived progress toward the goal of weight reduction mediated the connection between use of weight loss supplements and subsequent food consumption .


Participants with more positive attitudes toward weight loss supplements were more susceptible to the liberating effect of taking weight loss supplements on food intake .


Using weight loss supplements may produce unintended consequences on dietary self-regulation .


The public should pay more attention to the notion of psychological liberation when using weight loss supplements .


Intensive lifestyle interventions have been successful in reducing type 2 diabetes incidence .


Whether intensive programmes requiring face-to-face contact , trained staff and access to facilities are feasible , on a larger scale , has been debated .


The aim of this study is to determine the feasibility and efficacy of a lifestyle intervention for type 2 diabetes prevention in men using an assessor-blinded , parallel-group , randomised controlled trial .


The ` Type 2 Diabetes PULSE ( Prevention Using LifeStyle Education ) Programme for Men ' is a 6-month , self-administered , gender-tailored lifestyle intervention , with a multicomponent approach ( weight loss , dietary modification , aerobic exercise and resistance training ) .


Eligible men were aged 18-65 years , overweight/obese ( BMI 25-40 kgm ( -2 ) ) and at high-risk for type 2 diabetes ( score 12 , Australian diabetes risk tool ) .


Men with diagnosed prediabetes were eligible , but those with type 1 and 2 diabetes were ineligible .


Randomisation was stratified by age ( < 50 or 50 years ) and BMI category ( kgm ( -2 ) : 25-29 .9 ; 30-34 .9 ; 35-40 ) to the intervention or wait-list control group .


Data are collected at study entry ( baseline ) , 3 and 6 months .


The primary outcome is weight change at 6 months .


Secondary outcomes include : fasting plasma glucose , HbA1C , waist circumference , body composition , blood pressure , diet quality , aerobic fitness , muscular fitness and physical activity .


Generalised linear mixed models ( intention-to-treat ) will assess outcomes for treatment ( intervention vs. control ) , time ( baseline , 3 and 6-months ) and the treatment-by-time interaction .


The results will determine the efficacy of a type 2 diabetes prevention programme for men with potential for wide reach and dissemination .


Australian New Zealand Clinical Trials Registry ( ACTRN12612000721808 ) .


To assess the impact of rapid diagnostic tests on the diagnostic accuracy and treatment of malaria and non-severe fever in an Asian setting .


Patient randomised trial in primary level clinics .


Two areas of Afghanistan where Plasmodium vivax and Plasmodium falciparum are endemic ; one area with moderate transmission ( eastern region ) and one with low transmission ( northern region ) .


5794 patients of all ages with suspected malaria enrolled by 80 clinicians in 22 clinics .


Malaria rapid diagnostic tests were compared with clinical diagnosis where no parasite diagnostic test was available , longer established field microscopy , and recently introduced microscopy .


Proportion of patients appropriately treated with an antimalarial , defined as patients with P vivax who received chloroquine , patients with P falciparum who received artemisinin based combination therapy , and patients with no malaria parasites who did not receive an antimalarial .


Secondary outcomes included diagnostic test accuracy and the proportion of patients negative for malaria who received antibiotics and antimalarials .


In the low transmission area , comparing rapid diagnostic tests with clinical diagnosis , 65 % ( 212/325 ) versus 12 % ( 40/321 ) of febrile patients were appropriately treated for malaria ( adjusted odds ratio 92.7 , 95 % confidence interval 12.4 to 694.1 , P < 0.001 ) .


The proportion of patients who were negative for malaria and received an antibiotic was 57 % ( 185/325 ) in the rapid diagnostic test arm compared with 14 % ( 46/321 ) in the clinical diagnosis arm ( 16.9 , 3.8 to 75.4 , P < 0.001 ) .


In the comparison of rapid diagnostic test with microscopy in the moderate transmission area , 83.6 % ( 1696/2028 ) versus 76.3 % ( 1512/1983 ) of patients were appropriately treated for malaria ( 1.70 , 1.30 to 2.23 , P < 0.001 ) .


A higher proportion of P falciparum cases received appropriate treatment with artemisinin based combination therapy when malaria was diagnosed by rapid diagnostic test ( 82 % , 58/71 v 32 % , 24/76 ; 9.2 , 3.88 to 21.66 , P < 0.001 ) .


In South and central Asian regions of low to moderate malaria transmission where clinics lack capacity for diagnosis with rapid diagnostic tests or microscopy , the introduction of the tests should be considered to improve clinical care , reduce the overuse of antimalarials , and improve disease surveillance .


Many patients treated for primary hypothyroidism have an unexplained reduced quality of life ( QOL ) .


We studied the relation between QOL and various parameters in treated hypothyroid patients .


QOL analysis was done in 90 consecutive patients ( 77.8 % females ) treated for primary hypothyroidism .


QOL was measured by the questionnaires Short-Form 36 , Hospital Anxiety and Depression Scale and MFI20 .


Post hoc analysis was performed on the relation of QOL at baseline and BMI , thyroid hormones and other serum values .


QOL in patients was also compared to the general population .


QOL was decreased compared to the general population .


We found an inverse relationship between QOL and BMI .


A relationship between QOL and serum thyroid parameters or auto-antibodies could not be found .


Higher sex hormone binding globulin ( SHBG ) levels corresponded with a better QOL , which is explained by the negative association of SHBG with body weight and BMI .


A decreased QOL in hypothyroid patients on thyroxine treatment is related to a higher body weight ( BMI ) .


Weight gain needs more attention in the treatment of hypothyroidism .


Pregnancy is associated with increased risk for thromboembolic events .


Intermittent pneumatic compression ( IPC ) devices are the method of thromboprophylaxis in a nonpregnant population .


The aim of this study was to examine the effects of IPC on markers of fibrinolysis during cesarean delivery .


We conducted a randomized controlled trial from April 2009 to March 2010 of women undergoing scheduled elective cesarean delivery .


Forty-nine women were randomized to IPCs or usual care .


All participants had three blood samples obtained : ( 1 ) baseline , ( 2 ) 1 hour after randomization , and ( 3 ) 30 minutes after cesarean delivery .


Tissue-type plasminogen activator ( tPA ) , urokinase-type plasminogen activator ( uPA ) , thrombin-antithrombin complex ( TAT ) , plasminogen activator inhibitor-1 ( PAI-1 ) , and plasminogen activator inhibitor-2 ( PAI-2 ) levels were analyzed in each sample using an enzyme-linked immunosorbent assay .


Statistical analysis was performed using repeated measures two-way analysis of variance with = 0.05 .


There was a time-dependent change in tPA , uPA , and PAI-1 levels following delivery but no difference in TAT and PAI-2 levels with time .


There were no differences between women randomized to IPCs or usual care .


Markers of fibrinolysis were not significantly altered by IPCs in this study of low-risk pregnant women .


Further research regarding the mechanism and efficacy of IPCs in pregnant women is warranted .


Despite extensive use of enteral ( EN ) and parenteral nutrition ( PN ) in intensive care unit ( ICU ) populations for 4 decades , evidence to support their efficacy is extremely limited .


A prospective randomized trial was conducted evaluate the impact on outcomes of intensive medical nutrition therapy ( IMNT ; provision of > 75 % of estimated energy and protein needs per day via EN and adequate oral diet ) from diagnosis of acute lung injury ( ALI ) to hospital discharge compared with standard nutrition support care ( SNSC ; standard EN and ad lib feeding ) .


The primary outcome was infections ; secondary outcomes included number of days on mechanical ventilation , in the ICU , and in the hospital and mortality .


Overall , 78 patients ( 40 IMNT and 38 SNSC ) were recruited .


No significant differences between groups for age , body mass index , disease severity , white blood cell count , glucose , C-reactive protein , energy or protein needs occurred .


The IMNT group received significantly higher percentage of estimated energy ( 84.7 % vs 55.4 % , P < .0001 ) and protein needs ( 76.1 vs 54.4 % , P < .0001 ) per day compared with SNSC .


No differences occurred in length of mechanical ventilation , hospital or ICU stay , or infections .


The trial was stopped early because of significantly greater hospital mortality in IMNT vs SNSC ( 40 % vs 16 % , P = .02 ) .


Cox proportional hazards models indicated the hazard of death in the IMNT group was 5.67 times higher ( P = .001 ) than in the SNSC group .


Provision of IMNT from ALI diagnosis to hospital discharge increases mortality .


The aim of this study was to compare the total medicament doses and recovery profiles of patients for whom Bispectral Analysis ( BIS ) monitor was used to monitor sedation .


Thirty-four uncooperative paediatric patients aged 3-6 years who attended to the Department of Pediatric Dentistry for dental treatment were enrolled in the study .


Patients were randomly divided into 2 groups of 17 patients each .


Physiological variables including oxygen saturation , blood pressure and heart rate were recorded .


In one group ( BIS-monitored group ) , drugs were administered to maintain patients ' BIS values between 60-70 , while the other group ( Non-BIS-monitored Group ) was not monitored using BIS .


Data was evaluated by Chi-square , Mann Whitney U , Independent Samples t , Paired Samples t and Wilcoxon signed tests , with a p-value of < 0.05 considered to be statistically significant .


There was no significant difference in total anesthetic doses , incidence of adverse events or recovery profiles of patients between non - BIS-monitored and BIS-monitored groups ( p 0.05 ) .


However , distinct correlation was determined among mean values of UMSS and BIS values ( p < 0.05 ) .


BIS represents no advantage over the current commonly accepted methods for monitoring sedation depth in children .


The effect of 2-adrenergic receptor ( ADRB2 ) polymorphisms on the treatment response to longacting bronchodilators in chronic obstructive pulmonary disease ( COPD ) is unclear .


We aimed to establish whether ADRB2 polymorphisms differentially affected COPD exacerbation outcomes in response to tiotropium versus salmeterol .


We did a prespecified analysis of the ADRB2 polymorphisms Arg16Gly and Gln27Glu within the 1 year randomised , double-blind , double-dummy , parallel-group Prevention Of Exacerbations with Tiotropium in COPD ( POET-COPD ) trial , comparing the effects of treatment with tiotropium or salmeterol on exacerbations in 7376 patients with COPD .


One blood sample was collected for pharmacogenetic testing from each patient who elected to participate in the substudy .


Random assignment of patients to treatment groups was not stratified according to genotypes .


Genomic DNA was extracted from whole-blood specimens and samples were genotyped for the two SNPs , rs1042713 ( Arg16Gly ) and rs1042714 ( Gln27Glu ) .


All assays were done in technical duplicates and 10 % of samples that were randomly chosen were repeated as technical duplicates in a second independent genotyping process .


Our primary endpoint was the risk of a first exacerbation of COPD based on time to first exacerbation data .


An exacerbation of COPD was defined as the increase or new onset of more than one symptom of COPD ( cough , sputum , wheezing , dyspnoea , or chest tightness ) , with at least one of the symptoms lasting for 3 days or more and needing treatment with antibiotics or systemic glucocorticoids ( moderate exacerbations ) , or admission to hospital ( severe exacerbations ) .


POET-COPD is registered with ClinicalTrials.gov , number NCT00563381 .


5125 patients gave informed consent for genotyping .


The distributions of ADRB2 genotypes were well matched among groups .


Polymorphisms at aminoacid 27 did not affect exacerbation outcomes .


In the salmeterol group , patients with Arg16Arg genotype had a significantly reduced exacerbation risk compared with patients with Arg16Gly ( p = 00130 ) and Gly16Gly ( p = 00018 ) genotypes ( proportion of patients with at least one exacerbation was 323 % in Arg16Arg , 398 % in Arg16Gly , and 421 % in Gly16Gly ) .


By contrast , exacerbation risk was not modified by polymorphisms at aminoacid 16 in the tiotropium group .


The effect of the Arg16Gly polymorphism on treatment response to salmeterol was dependent on the use of inhaled corticosteroids ( ICS ) .


In patients untreated with ICS at baseline , Arg16Gly and Arg16Arg genotypes were associated with significantly prolonged time to first exacerbation compared with Gly16Gly ( vs Arg16Gly p = 00164 ; Arg16Arg p = 00316 ; proportion of patients with at least one exacerbation was 283 % in Arg16Arg , 316 % in Arg16Gly , and 392 % in Gly16Gly ) , whereas in patients on ICS at baseline , only the Arg16Arg genotype was associated with significantly prolonged time to first exacerbation compared with Gly16Gly ( p = 00198 ; not Arg16Gly p = 064 ; proportion of patients with at least one exacerbation was 359 % in Arg16Arg , 467 % in Arg16Gly , and 448 % in Gly16Gly ) .


The respiratory disorders , in particular worsening of COPD , were the most common serious adverse events .


Patients with the Arg16Arg genotype had better exacerbation outcomes in response to salmeterol than Gly16Gly and Arg16Gly genotypes , suggesting a potential differential Arg16Gly genotype effect on treatment response to longacting - agonists ( LABAs ) .


However , the use of ADRB2 polymorphisms for predicting LABA treatment response is still limited and further prospective validation will be needed to advance the mechanistic understanding of - adrenergic polymorphisms and their association with clinical features of COPD .


Boehringer Ingelheim and Pfizer .


This prospective randomized study aimed to compare the safety and efficacy of the TVT-Secur ( TVT-S ) with the trans vaginal obturator tape ( TVT-O ) for the treatment of stress urinary incontinence .


We set out to enroll 136 patients in our study .


106 patients with stress urinary incontinence were randomized to either the TVT-S ( n = 56 ) or TVT-O ( n = 50 ) procedure .


Patients were evaluated postoperatively at 2months and 1year .


Our primary outcome was objective cure measured by the cough test .


Secondary outcomes of subjective symptoms , questionnaires , pain scores , complications , and urodynamic studies were also included .


Statistical analysis was by Chi-squared , Kruskal-Wallis , Wilcoxon , and Fisher 's exact tests as appropriate .


P values of < 0.05 were considered significant .


Objective cure rates were better for TVT-O compared with TVT-S at 1year ( 86 % and 63 % respectively , p = 0.01 ) .


Subjective cure rates were 88 % for TVT-O and 63 % for TVT-S .


Quality of life scores through questionnaires improved in both groups and were not statistically different .


Initial post-operative groin pain was more prevalent in the TVT-O group ; however , this resolved quickly with time .


TVT-O was superior to TVT-S in the objective cure of stress urinary incontinence at 1-year follow-up .


Changes in DNA methylation have been associated with traffic-related air pollution in observational studies , but the specific mechanisms and temporal dynamics therein have not been explored in a controlled study of asthmatics .


In this study , we investigate short-term effects of diesel exhaust inhalation on DNA methylation levels at CpG sites across the genome in circulating blood in asthmatics .


A double-blind crossover study of filtered air and diesel exhaust exposures was performed on sixteen non-smoking asthmatic subjects .


Blood samples were collected pre-exposure , and then 6 and 30hours post-exposure .


Peripheral blood mononuclear cell DNA methylation was interrogated using the Illumina Infinium HumanMethylation450 Array .


Exposure-related changes in DNA methylation were identified .


In addition , CpG sites overlapping with Alu or LINE1 repetitive elements and candidate microRNA loci were also analyzed .


DNA methylation at 2827 CpG sites were affected by exposure to diesel exhaust but not filtered air ; these sites enriched for genes involved in protein kinase and NFkB pathways .


CpG sites with significant changes in response to diesel exhaust exposure primarily became less methylated , with a site residing within GSTP1 being among the significant hits .


Diesel exhaust-associated change was also found for CpG sites overlapping with Alu and LINE1 elements as well as for a site within miR-21 .


Short-term exposure to diesel exhaust resulted in DNA methylation changes at CpG sites residing in genes involved in inflammation and oxidative stress response , repetitive elements , and microRNA .


This provides plausibility for the role of DNA methylation in pathways by which airborne particulate matter impacts gene expression and offers support for including DNA methylation analysis in future efforts to understand the interactions between environmental exposures and biological systems .


Psoriasis affecting sites such as the hands , feet and nails can be particularly difficult to treat .


There are limited data on the efficacy of biological agents to treat these specific localizations .


This analysis of a phase 2 regimen-finding study evaluated the efficacy of secukinumab in subjects with moderate-to-severe psoriasis and non-pustular involvement of the hands , feet and/or nails .


Subjects were randomized ( 1 : 2 : 2 : 1 ) to one of three subcutaneous secukinumab 150-mg induction regimens [ Single ( Week 0 ) , Monthly ( Weeks 0 , 4 , 8 ) , Early ( Weeks 0 , 1 , 2 , 4 ) ] or placebo .


In the subgroup ( n = 131 ) with hand and/or foot psoriasis [ baseline 5-point hand/foot Investigator 's Global Assessment ( IGA ) score 2 ] , efficacy was assessed as percentage of subjects achieving an IGA response [ a score of 0 ( clear ) or 1 ( minimal ) and an improvement of 2 points on the 5-point hand/foot scale vs. baseline ] at Week 12 .


In the subgroup ( n = 304 ) with fingernail psoriasis ( baseline composite score 1 ) , efficacy was assessed as mean percentage change from baseline to Week 12 in a composite score .


At Week 12 , a markedly higher percentage of subjects with hand and/or foot psoriasis achieved an IGA response with the Early regimen vs. placebo ( 54.3 % vs. 19.2 % , P = 0.005 ) .


The composite fingernail score improved with the Early and Monthly regimens , but worsened with placebo [ percentage mean change from baseline ( SE ) : -19.1 % ( 6.12 ) and -10.6 % ( 7.06 ) vs. 14.4 % ( 11.92 ) ; P = 0.010 vs. placebo for Early , P = 0.027 for Monthly ) .


Secukinumab was well tolerated .


Secukinumab demonstrated a beneficial effect on psoriasis of the hands/feet/nails in this short-term assessment .


Postal questionnaires are simple and economical for collecting outcome data for randomised controlled trials ( RCTs ) but are prone to non-response .


In the RECORD trial ( a large pragmatic publicly funded RCT in UK ) non-responders were sent a reminder and another questionnaire at 1 year , of which 40 % were returned .


In subsequent years we investigated the effect of an advance telephone call to non-responders on responses rate to reminder questionnaires and the next questionnaire 4 months later .


Non-responders to annual questionnaires were randomised to receive a telephone call from the trial office ahead of the reminder questionnaire in addition to the usual reminder schedule ( n = 390 ) or to a control group that received the usual reminder schedule only ( n = 363 ) .


The primary outcome was response to the reminder questionnaire within 21 days ; secondary outcomes were response to a questionnaire 4 months later ; completeness of quality of life instruments ; and the number of participants declining further follow-up .


Results are presented as odds ratios from a logistic regression intention-to-treat ( ITT ) analysis and then percentage difference and 95 % confidence intervals ( CI ) for both ITT and average treatment effect on the treated ( ATT ) analyses .


The proportions that responded were 67.8 % ( 265/390 ) in the intervention group compared to 62.5 % ( 227/363 ) in the control group .


The ITT estimate was a 5.4 % increase ( 95 % CI -1.4 to 12.2 ) .


Four months later percentages responding were 51.8 % ( 202 ) and 42.7 % ( 155 ) .


The ITT estimate was a 9.1 % increase ( 95 % CI 2.0 to 16.2 ) .


In the intervention group 12.3 % ( 48/390 ) of participants were not telephoned because questionnaires were returned before the scheduled telephone call .


ATT estimates adjusting for this were 6.2 % ( 95 % CI -1.6 to 14.0 ) and 10.4 % ( 95 % CI 2.2 to 18.5 ) , respectively .


The telephone call resulted in a slight increase in response to the reminder questionnaire , however at 4 months later the proportion in the telephoned group responding was greater .


This study suggests that pre-notification telephone calls may only be worthwhile if further questionnaires are to be sent out soon after reminder questionnaires .


Current Clinical Trials ISRCTN51647438 .


Effective lung collapse of the nonventilated lung can facilitate thoracic surgery .


Previous studies showed that using a bronchial blocker could delay the time of lung collapse compared with using a double-lumen endotracheal tube .


We hypothesized that the use of nitrous oxide ( N2O ) in the inspired gas mixture during 2-lung ventilation would lead to clinically relevant improvement of lung collapse during subsequent 1-lung ventilation with a bronchial blocker .


Fifty patients were randomized into 2 groups : N2O ( n = 26 ) or O2 ( n = 24 ) .


The N2O group received a gas mixture of oxygen and N2O ( FIO2 = 0.5 ) , and the O2 group received 100 % oxygen until the start of 1-lung ventilation .


Lung isolation was achieved with an Arndt wire-guided bronchial blocker ( Cook Critical Care , Bloomington , IN .


After turning patients to the lateral decubitus position , the cuff of the bronchial blocker was inflated under fiberoptic bronchoscopy surveillance , and thereafter , the dependent lung was ventilated with 100 % oxygen during 1-lung ventilation in both groups .


Surgeons blinded to the randomization evaluated the degree of lung collapse by using a verbal rating scale ( lung collapse scale , 0 = no collapse to 10 = complete collapse ) at 5 minutes after opening the pleura .


Also , as secondary outcomes , lung collapse at 1 and 10 minutes were evaluated .


The score on the lung collapse scale in the N2O group was significantly higher compared with the O2 group at 5 minutes after opening the pleura ( 7 vs 5 , P < 0.001 , WMWodds = 7.3 , 95 % confidence interval ( CI ) , 6.0 to 9.0 ) .


It was also higher in the N2O group at 10 minutes ( 10 vs 7 , P < 0.001 , WMWodds = 10.1 , 95 % CI , 1.9-13 .3 ) .


The lung collapse scale between groups was not significant at 1 minute after opening the pleura ( 2 vs 2 , P = 0.76 , WMWodds = 1.1 , 95 % CI , 0.96-1 .2 ) .


None of the patients developed hypoxia ( SpO2 < 92 % ) during 1-lung ventilation .


Filling the lung with 50 % N2O before 1-lung ventilation facilitated lung collapse 5 minutes after opening the chest compared with 100 % oxygen when a bronchial blocker was used .


The N2O/O2 mixture ( FIO2 = 0.5 ) did not have a harmful effect on subsequent arterial oxygenation during 1-lung ventilation .


To compare the therapeutic warfarin and aspirin efficacies for treatments of atrial fibrillation ( AF ) complicated with stable coronary heart disease particularly in older Chinese patients .


In our prospective study 101 patients with AF and stable coronary heart disease older than 80 years were randomized into two groups .


One group ( n = 51 ) basically received 1.25 mg/day warfarin per os , followed by addition of 0.5 - 1.0 mg/day from day 3 - 5 if the international normalized ratio ( INR ) was initially < 1.5 and in order to achieve a maintained INR between 1.6 and 2.5 ( warfarin group ) .


The second group ( n = 50 ) received 100 mg aspirin per day ( control group ) .


All patients were medicated and monitored for a period of 2 years .


The primary endpoint was the occurrence of ischemic stroke or systemic embolism , and the composite secondary endpoint was non-fatal myocardial infarction and all causes of death .


For safety evaluation , the hemorrhage rates were recorded .


The warfarin medication was superior regarding the overall occurrence of ischemic stroke or systemic embolism as well as non-fatal myocardial infarction and all causes of death outcomes compared to aspirin administration during the 2 years of medication ( 17.6 % vs. 36.0 % , p = 0.03 ) , while there was no significant difference of mild ( 5 vs. 4 ) , severe ( 2 vs. 1 ) , and fatal ( 1 vs. 1 ) hemorrhage incidences between the warfarin and aspirin groups ( p > 0.05 ) .


Warfarin was found to be more efficacious than aspirin for an anticoagulation therapy of older Chinese patients with AF and stable coronary heart disease .


A major disadvantage of photorefractive keratectomy is postoperative pain and discomfort .


This study aims to evaluate whether topical diclofenac 0.1 % therapy adds any extra benefit to systemic diclofenac in controlling pain after photorefractive keratectomy .


Prospective randomized , double-masked clinical trial applied in the Khatam-al-Anbia Eye Hospital , Mashhad University of Medical Sciences , Mashhad , Iran .


Sixty-eight individuals ( age range , 18-35 years ) having bilateral photorefractive keratectomy for myopic correction with or without astigmatism .


All patients received 100mg of extended-release oral diclofenac two times ( 12-h interval ) before photorefractive keratectomy surgery .


Postoperatively , patients were randomized into the case and control groups .


Case group was administered the diclofenac 0.1 % drop , one drop 2h preoperatively and four times daily postoperatively for 3 days , whereas the control group was given artificial tears instead .


Pain level , photophobia and functional activity were evaluated by the patient after operation .


Two days after surgery , no statistically significant difference in pain level was noted between both groups .


In addition , photophobia and functional activity was not different between the case and control groups .


Eyelid oedema and conjunctival injection levels were significantly higher in the control group ( P < 0.001 ) .


Administration of topical diclofenac to a standardized postoperative pain regime did not alleviate post-photorefractive keratectomy pain , although it is effective in local signs like eyelid oedema and conjunctival injection .


It can be concluded that oral diclofenac is sufficient in the management of post-photorefractive keratectomy pain and addition of the topical diclofenac is unnecessary .


To explore the benefit of rapid induction with intravitreal bevacizumab for neovascular age-related macular degeneration ( AMD ) .


Single-institution prospective randomized pilot study .


Patients with treatment-nave neovascular AMD were randomized 1:1:1 into 1 of 3 groups based on the induction sequence : ( 1 ) every 2 weeks for 3 consecutive injections ; ( 2 ) every 4 weeks for 3 consecutive injections ; and ( 3 ) immediate pro re nata ( prn ) after the first injection .


Retinal angiomatous proliferation and polypoidal choroidal vasculopathy were excluded .


Best-corrected visual acuity ( BCVA ) and central retinal thickness using optical coherence tomography ( OCT ) were measured at baseline and at each follow-up .


After induction , bevacizumab was administered as needed based mainly on OCT. .


Main outcome measure was mean initial fluid-free interval after induction .


Secondary outcomes were mean improvement in BCVA and central retinal thickness .


Each group included 30 patients ( 30 eyes ) .


Mean initial fluid-free interval was 2.4 , 3.4 , and 3.5 months for biweekly induction , monthly induction , and immediate prn groups , respectively ( P = .03 ) .


Significance was lost when corrected for age and sex ( P = .073 ) .


Mean improvement in BCVA , central retinal thickness , and total number of injections were similar among the groups at 12 months .


Six eyes in the biweekly induction group developed subretinal fibrosis vs no eyes in the other 2 groups ( P = .003 ) .


Biweekly induction with intravitreal bevacizumab for treatment-nave neovascular AMD does not increase initial fluid-free interval or cause significant anatomic and functional benefit compared to monthly induction or immediate prn .


There is also the potential development of subretinal fibrosis with biweekly induction .


Double blind pre-test post-test control group design .


To compare the isokinetic quadriceps torque , standardized stair-climbing task ( SSCT ) and pain during SSCT between subjects diagnosed with knee osteoarthritis pre and post kinesio tape ( KT ) application with and without tension .


Strength of the quadriceps and torque producing capability is frequently found to be compromised in knee osteoarthritis .


The efficacy of KT in improving isokinetic quadriceps torque in knee osteoarthritis is unknown , forming the basis for this study .


Forty subjects were randomly allocated to either the experimental ( therapeutic KT with tension ) or control group ( sham KT without tension ) with the allocation being concealed .


Pre and post test measurements of isokinetic quadriceps torque , SSCT and pain during SSCT were carried out by a blinded assessor .


A large effect size with significant improvements in the peak quadriceps torque ( concentric and eccentric at angular velocities of 90 per second and 120 per second ) , SSCT and pain were obtained in the experimental group when compared to the control group .


Application of therapeutic KT is effective in improving isokinetic quadriceps torque , SSCT and reducing pain in knee osteoarthritis .


In the phase IV , open-label , single-arm study NCT01203917 , first-line gefitinib 250 mg/d was effective and well tolerated in Caucasian patients with epidermal growth factor receptor ( EGFR ) mutation-positive non-small-cell lung cancer ( previously published ) .


Here , we report EGFR mutation analyses of plasma-derived , circulating-free tumor DNA .


Mandatory tumor and duplicate plasma ( 1 and 2 ) baseline samples were collected ( all screened patients ; n = 1060 ) .


Preplanned , exploratory analyses included EGFR mutation ( and subtype ) status of tumor versus plasma and between plasma samples .


Post hoc , exploratory analyses included efficacy by tumor and plasma EGFR mutation ( and subtype ) status .


Available baseline tumor samples were 1033 of 1060 ( 118 positive of 859 mutation status known ; mutation frequency , 13.7 % ) .


Available plasma 1 samples were 803 of 1060 ( 82 positive of 784 mutation status known ; mutation frequency , 10.5 % ) .


Mutation status concordance between 652 matched tumor and plasma 1 samples was 94.3 % ( 95 % confidence interval [ CI ] , 92.3-96 .0 ) ( comparable for mutation subtypes ) ; test sensitivity was 65.7 % ( 95 % CI , 55.8-74 .7 ) ; and test specificity was 99.8 % ( 95 % CI , 99.0-100 .0 ) .


Twelve patients of unknown tumor mutation status were subsequently identified as plasma mutation-positive .


Available plasma 2 samples were 803 of 1060 ( 65 positive of 224 mutation status-evaluable and - known ) .


Mutation status concordance between 224 matched duplicate plasma 1 and 2 samples was 96.9 % ( 95 % CI , 93.7-98 .7 ) .


Objective response rates are as follows : mutation-positive tumor , 70 % ( 95 % CI , 60.5-77 .7 ) ; mutation-positive tumor and plasma 1 , 76.9 % ( 95 % CI , 65.4-85 .5 ) ; and mutation-positive tumor and mutation-negative plasma 1 , 59.5 % ( 95 % CI , 43.5-73 .7 ) .


Median progression-free survival ( months ) was 9.7 ( 95 % CI , 8.5-11 .0 ; 61 events ) for mutation-positive tumor and 10.2 ( 95 % CI , 8.5-12 .5 ; 36 events ) for mutation-positive tumor and plasma 1 .


The high concordance , specificity , and sensitivity demonstrate that EGFR mutation status can be accurately assessed using circulating-free tumor DNA .


Although encouraging and suggesting that plasma is a suitable substitute for mutation analysis , tumor tissue should remain the preferred sample type when available .


To demonstrate proof of concept for a smart phone-empowered community health worker ( CHW ) model of care for breast health promotion , clinical breast examination ( CBE ) , and patient navigation in rural Bangladesh .


This study was a randomized controlled trial ; July 1 to October 31 , 2012 , 30 CHWs conducted door-to-door interviews of women aged 25 and older in Khulna Division .


Only women who disclosed a breast symptom were offered CBE .


Arm A : smart phone with applications to guide interview , report data , show motivational video , and offer appointment for women with an abnormal CBE .


Arm B : smart phone/applications identical to Arm A plus CHW had training in `` patient navigation '' to address potential barriers to seeking care .


Arm C : control arm ( no smart phone ; same interview recorded on paper ) .


Outcomes are presented as the `` adherence '' ( to advice regarding a clinic appointment ) for women with an abnormal CBE .


This study was approved by Women 's College Hospital Research Ethics Board ( Toronto , Ontario , Canada ) and district government officials ( Khulna , Bangladesh ) .


Funded by Grand Challenges Canada .


In 4 months , 22,337 women were interviewed ; < 1 % declined participation , and 556 women had an abnormal CBE .


Control group CHWs completed fewer interviews , had inferior data quality , and identified significantly fewer women with abnormal breast exams compared with CHWs in arms A and B. Arm B had the highest adherence .


CHWs guided by our smart phone applications were more efficient and effective in breast health promotion compared with the control group .


CHW `` navigators '' were most effective in encouraging women with an abnormal breast examination to adhere to advice regarding clinic attendance .


To evaluate the preemptive analgesia of ketoprofen in comparison with diclofenac after mandibular third molar surgery .


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


Forty patients were randomized into two treatment groups ( each with 20 patients ) by using a series of random numbers : group A received ketoprofen 100 mg and group B received diclofenac 75 mg , all intramuscularly .


Surgery was done 30 minutes after analgesic treatments .


The durations of analgesia , pain intensity , analgesic consumption , and side effects were evaluated .


The statistical analysis was done using the chi-square , Student t , Mann-Whitney U , and Log-Rank tests .


The duration of analgesia was longer in the ketoprofen group when compared with the diclofenac group .


The number of patients taking the first rescue analgesic at 6 hours was lower in the ketoprofen group in comparison with the diclofenac group .


Patients who received ketoprofen had lower pain intensity compared with patients who received diclofenac .


Intramuscular ketoprofen 100 mg is more effective than intramuscular diclofenac 75 mg after mandibular third molar extraction when used as a preemptive analgesic .


The 29-item Multiple Sclerosis Impact Scale ( MSIS-29 ) was developed to examine the impact of multiple sclerosis ( MS ) on physical and psychological functioning from a patient 's perspective .


To determine the responder definition ( RD ) of the MSIS-29 physical impact subscale ( PHYS ) in a group of patients with relapsing-remitting MS ( RRMS ) participating in a clinical trial .


Data from the SELECT trial comparing daclizumab high-yield process with placebo in patients with RRMS were used .


Physical function was evaluated in SELECT using three patient-reported outcomes measures and the Expanded Disability Status Scale ( EDSS ) .


Anchor - and distribution-based methods were used to identify an RD for the MSIS-29 .


Results across the anchor-based approach suggested MSIS-29 PHYS RD values of 6.91 ( mean ) , 7.14 ( median ) and 7.50 ( mode ) .


Distribution-based RD estimates ranged from 6.24 to 10.40 .


An RD of 7.50 was selected as the most appropriate threshold for physical worsening based on corresponding changes in the EDSS ( primary anchor of interest ) .


These findings indicate that a 7.50 point worsening on the MSIS-29 PHYS is a reasonable and practical threshold for identifying patients with RRMS who have experienced a clinically significant change in the physical impact of MS.


Fostering patients ' sense of meaning is an essential task for palliative care clinicians .


Few studies have reported the effects on nurses of a short-term training program aimed at improving skills to relieve feelings of meaninglessness in terminally ill cancer patients .


The primary aim of this study was to determine the impact on nurses of a novel two-day education program focusing on care that addresses patients ' feelings of meaninglessness .


Measured were impacts on nurses ' confidence , self-reported practice , attitudes toward caring for such patients , burnout , meaning of life , and knowledge .


This study was a randomized controlled trial using the waiting list control .


Intervention consisted of a two-day interactive education program .


A total of 76 nurses randomly allocated to two groups completed the study .


Outcome measures included confidence scale ; self-reported practice scale ; scales of nursing attitudes toward caring for patients who experience feelings of meaningless ( willingness to help , positive appraisal , helplessness , nurse-perceived value of being , and nurse-perceived value of patients ' inner power ) ; Maslach burnout scale , Functional Assessment of Chronic Illness Therapy-Spiritual , and knowledge scale .


There were significant intervention effects in nurse-reported confidence and nurse-perceived value of patients ' inner power .


Nurse-reported helplessness showed marginally significant improvement after intervention ( p = 0.067 ) .


No significant intervention effects were observed in the self-reported practice scale ; attitudes toward caring for patients ( willingness to help , positive appraisal , and nurse-perceived value of being ) ; burnout scale , meaning of life ; and knowledge score .


The percentages of nurses who evaluated this program as useful or very useful were 95 % ( understanding the conceptual framework ) and 85 % ( helping to learn how to provide care for patients feeling meaninglessness in clinical practice ) .


This short-term educational intervention had a significant beneficial effect on nurses ' confidence and modest effects on attitudes .


Peginterferon lambda-1a ( Lambda ) is a type-III interferon with similar antiviral activity to alfa interferons but with a diminished extrahepatic receptor distribution , reducing the risk for extrahepatic adverse events .


This was a randomized , blinded , actively-controlled , multicentre phase 2b dose-ranging study in patients chronically infected with HCV genotypes 1-4 .


Treatment-naive patients received Lambda ( 120/180/240 g ) or peginterferon alfa-2a ( alfa ; 180 g ) once-weekly with ribavirin for 24 ( genotypes [ GT ] 2,3 ) or 48 ( GT1 ,4 ) weeks .


Rates of undetectable HCV-RNA at week 12 ( complete early virologic response [ cEVR ] ; primary end point ) were significantly higher in GT1 ,4 patients receiving Lambda vs. alfa ( 170/304 , 56 % vs. 38/103 , 37 % ) ; with similar cEVR rates for GT2 ,3 ( 80/88 , 91 % vs. 26/30 , 87 % ) .


Rates of undetectable HCV-RNA at week 4 were significantly higher on 180 g ( 15/102 , 15 % GT1 ,4 ; 22/29 , 76 % GT2 ,3 ) and 240 g ( 17/104 , 16 % GT1 ,4 ; 20/30 , 67 % GT2 ,3 ) Lambda than alfa ( 6/103 , 6 % GT1 ,4 ; 9/30 , 30 % GT2 ,3 ) .


Sustained virologic responses ( post-treatment week 24 ) were comparable between Lambda and alfa for GT1 ,4 ( 37-46 % Lambda ; 37 % alfa ) and GT2 ,3 ( 60-76 % Lambda ; 53 % alfa ) .


Aminotransferase and/or bilirubin elevations were the primary dose-limiting abnormalities for Lambda ; a sponsor-mandated 240 to 180 g dose reduction was therefore implemented .


Serious adverse events were comparable ( 3-13 % Lambda ; 3-7 % alfa ) .


Grade 3-4 haemoglobin , neutrophil , and platelet reductions were lower on Lambda than alfa .


Among alfa patients , 28/133 ( 21 % ) had peginterferon and 31/133 ( 23 % ) had ribavirin dose reductions for haematologic abnormalities vs. 0/392 and 8/392 ( 2 % ) on Lambda .


Lambda demonstrated fewer musculoskeletal ( 16-28 % vs. 47-63 % ) and influenza-like events ( 8-23 % vs. 40-46 % ) than alfa .


Lambda was associated with improved or similar rates of virologic response with fewer extrahepatic adverse events than alfa in chronic HCV infection .


The purpose of this study is to compare the diagnostic performance and radiation exposure of flat-panel CT arthrography for cartilage defect detection in the ankle joint to standard MDCT arthrography , using gross anatomy and thermoluminescent dosimetry as reference standards .


Ten cadaveric ankle specimens were obtained from individuals who had willed their bodies to science .


Five milliliters of a mixture of diluted ioxaglate and saline were injected .


Specimens were examined consecutively with the use of flat-panel CT and MDCT .


Radiation doses of flat-panel CT and MDCT were recorded using thermoluminescent dosimeters .


Flat-panel CT and MDCT arthrography examinations were blinded and randomly evaluated by two musculoskeletal radiologists in consensus .


In each ankle specimen , eight cartilage areas were assessed separately : medial talar surface , medial talar trochlea , lateral talar trochlea , lateral talar surface , tibial malleolus , medial tibial pla-fond , lateral tibial plafond , and fibular malleolus .


Findings at flat-panel CT and MDCT arthrography were compared with macroscopic assessments in 80 cartilage areas .


For the detection of cartilage lesions , flat-panel CT showed a sensitivity of 80 % , specificity of 98 % , and accuracy of 94 % , and MDCT arthrography showed a sensitivity of 55 % , specificity of 98 % , and accuracy of 88 % .


Flat-panel CT and MDCT arthrography showed almost perfect ( = 0.83 ) and substantial ( = 0.65 ) agreement , respectively , with anatomic examination .


Radiation dose was significantly lower for flat-panel CT ( mean , 2.1 mGy ; range , 1.1-3 .0 mGy ) than for MDCT ( mean , 47.2 mGy ; range , 39.3-53 .8 mGy ) ( p < 0.01 ) .


Flat-panel CT arthrography is accurate for detecting cartilage defects in the ankle joint and is an alternative to MDCT arthrography that may have better diagnostic performance and may permit the use of a lower radiation dose .


Currently , early weight-loss predictions of long-term weight-loss success rely on fixed percent-weight-loss thresholds .


The objective was to develop thresholds during the first 3 mo of intervention that include the influence of age , sex , baseline weight , percent weight loss , and deviations from expected weight to predict whether a participant is likely to lose 5 % or more body weight by year 1 .


Data consisting of month 1 , 2 , 3 , and 12 treatment weights were obtained from the 2-y Preventing Obesity Using Novel Dietary Strategies ( POUNDS Lost ) intervention .


Logistic regression models that included covariates of age , height , sex , baseline weight , target energy intake , percent weight loss , and deviation of actual weight from expected were developed for months 1 , 2 , and 3 that predicted the probability of losing < 5 % of body weight in 1 y. Receiver operating characteristic ( ROC ) curves , area under the curve ( AUC ) , and thresholds were calculated for each model .


The AUC statistic quantified the ROC curve 's capacity to classify participants likely to lose < 5 % of their body weight at the end of 1 y.


The models yielding the highest AUC were retained as optimal .


For comparison with current practice , ROC curves relying solely on percent weight loss were also calculated .


Optimal models for months 1 , 2 , and 3 yielded ROC curves with AUCs of 0.68 ( 95 % CI : 0.63 , 0.74 ) , 0.75 ( 95 % CI : 0.71 , 0.81 ) , and 0.79 ( 95 % CI : 0.74 , 0.84 ) , respectively .


Percent weight loss alone was not better at identifying true positives than random chance ( AUC 0.50 ) .


The newly derived models provide a personalized prediction of long-term success from early weight-loss variables .


The predictions improve on existing fixed percent-weight-loss thresholds .


Future research is needed to explore model application for informing treatment approaches during early intervention .


Previous studies have shown good clinical results in patients with midshaft clavicular fractures treated with reconstruction plate fixation or elastic stable intramedullary nailing .


The objective of this study was to compare these methods in terms of clinical and radiographic results .


In this prospective , randomized controlled trial , fifty-nine patients with displaced midshaft clavicular fractures were randomly assigned to receive fixation with either a reconstruction plate ( thirty-three patients ) , known as the plate group , or elastic stable intramedullary nailing ( twenty-six patients ) , known as the nail group .


The primary outcome was the six-month Disabilities of the Arm , Shoulder and Hand ( DASH ) score .


The secondary outcomes included the Constant-Murley score , time to fracture union , residual shortening , level of postoperative pain , percentage of satisfied patients , and complication rates .


The mean six-month DASH score was 9.9 points in the plate group and 8.5 points in the nail group ( p = 0.329 ) .


Similarly , there were no differences in the twelve-month DASH and Constant-Murley scores .


Time to union was equivalent ( p = 0.352 ) between the groups at 16.8 weeks for the plate group and 15.9 weeks for the nail group , whereas the residual shortening was 0.4 cm greater in the plate group ( p = 0.032 ) .


The visual analog scale pain score and the satisfaction rate were similar between the groups .


Implant-related pain was more frequent in the nail group ( p = 0.035 ) .


There were no differences in terms of major complications .


Reconstruction plates and elastic stable intramedullary nailing yielded similar functional results , time to union , level of postoperative pain , and patient satisfaction rates .


Both methods were safe in terms of major complications .


To describe a feasibility study focused on a telemonitoring approach to self-managed kinesiotherapy sessions for the rehabilitation of hand function in patients with systemic sclerosis ( SSc ) and rheumatoid arthritis ( RA ) .


Ten patients with SSc and 10 with RA were enrolled in a 3-month controlled trial ( approval no. 9751/2012 - Italian Department of Health ) to perform a home kinesiotherapy protocol , consisting of strengthening and mobility exercises , using a newly developed telemedicine system ( a portable device and the related telemonitoring infrastructure ) .


A further 10 patients with SSc and 10 with RA were enrolled as controls to perform a similar home kinesiotherapy protocol with the aid of common daily-life objects .


Both groups were evaluated at baseline and at followup , after 6 and 12 weeks .


The primary outcome of the trial was hand function measured by Dreiser 's index ( Functional Index for Hand OA , FIHOA ) , Health Assessment Questionnaire ( HAQ ) , and the Hand Mobility in Scleroderma ( HAMIS ) test ( only for SSc ) .


Patients with SSc showed an improvement of FIHOA in both arms ( p < 0.01 ) but the HAQ ( p = 0.016 ) and the HAMIS test ( right hand p = 0.016 , left hand p = 0.075 ) improved significantly only in the experimental arm .


Patients with RA showed a statistically significant improvement of FIHOA ( p = 0.013 ) and HAQ ( p = 0.015 ) in the experimental arm , while patients in the control arm did not significantly improve .


However , no statistically significant differences in outcome measures between treatment methods were observed .


Withdrawals were higher in control arms ( SSc 20 % ; RA 30 % ) than in experimental arms ( SSc 10 % ; RA 10 % ) .


Telemonitoring of self-administered kinesiotherapy programs is a promising approach to the rehabilitation of hand functions in patients with rheumatic disease .


Mobile-bearing total knee arthroplasty ( TKA ) implants were developed as an alternative to fixed-bearing implants because of their theoretical advantages related to wear and range of motion .


For all that , none of the short-term and medium-term studies published so far have reported a significant clinical improvement related to these mobile bearings .


The goal of this study was to compare the outcomes of fixed and mobile bearings in the same type of TKA model after a longer follow-up .


This series initially comprised 100 patients with a mean age of 73 years who were operated by a single surgeon .


The patients were randomised to receive either a fixed bearing TKA implant or a mobile one ; their outcomes evaluated after a mean of 9 years ( 7.2-12 .2 ) follow-up .


Twenty-two patients died before the final review , 15 were lost to follow-up and 2 were excluded .


This resulted in 30 patients with a mobile-bearing knee and 31 with a fixed-bearing knee being available for analysis .


There were no significant clinical differences between the groups receiving a fixed or mobile bearing in terms of the range of motion , subjective outcomes or validated outcomes measured , such as the self-reported Oxford or the IKS .


Conversely , there was a significantly higher rate of osteolysis in the fixed-bearing group , but it was not clinically relevant .


This study , which has the longest published follow-up , confirms the results found in the seven randomised studies published up to now : there are no significant differences in the clinical outcomes between fixed-bearing and mobile-bearing inserts of the same TKA model .


Although the mobile bearing knees had a better radiographic appearance , this did not translate to better clinical outcomes .


In practice , the superiority of mobile bearings is solely theoretical .


Prospective randomised study .


To examine whether a pistachio-rich diet reduces the prediabetes stage and improves its metabolic risk profile .


Prediabetic subjects were recruited to participate in this Spanish randomized clinical trial between 20 September 2011 and 4 February 2013 .


In a crossover manner , 54 subjects consumed two diets , each for 4 months : a pistachio-supplemented diet ( PD ) and a control diet ( CD ) .


A 2-week washout period separated study periods .


Diets were isocaloric and matched for protein , fiber , and saturated fatty acids .


A total of 55 % of the CD calories came from carbohydrates and 30 % from fat , whereas for the PD , these percentages were 50 and 35 % , respectively ( including 57 g/day of pistachios ) .


Fasting glucose , insulin , and HOMA of insulin resistance decreased significantly after the PD compared with the CD .


Other cardiometabolic risk markers such as fibrinogen , oxidized LDL , and platelet factor 4 significantly decreased under the PD compared with the CD ( P < 0.05 ) , whereas glucagon-like peptide-1 increased .


Interleukin-6 mRNA and resistin gene expression decreased by 9 and 6 % , respectively , in lymphocytes after the pistachio intervention ( P < 0.05 , for PD vs. CD ) .


SLC2A4 expression increased by 69 % in CD ( P = 0.03 , for PD vs. CD ) .


Cellular glucose uptake by lymphocytes decreased by 78.78 % during the PD ( P = 0.01 , PD vs. CD ) .


Chronic pistachio consumption is emerging as a useful nutritional strategy for the prediabetic state .


Data suggest that pistachios have a glucose - and insulin-lowering effect , promote a healthier metabolic profile , and reverse certain metabolic deleterious consequences of prediabetes .


To determine the effect of food-toy enrichment combined with cage-behavior training on desirable behaviors in shelter dogs and adoption rates .


Randomized controlled clinical trial .


107 dogs .


Dogs placed up for adoption in a municipal shelter were randomly assigned to either an experimental group ( n = 48 ) or control group ( 59 ) .


Experimental group subjects were exposed to an environmental enrichment and training protocol consisting of twice-daily cage-behavior training and daily provision of a food-filled toy .


Cage-behavior training included operant conditioning via positive reinforcement of desirable behaviors , including approaching the front of the cage , sitting or lying , and remaining quiet when approached .


Behavioral observations were performed by a blinded observer in a scan-sampling technique on day 0 ( first day on adoption floor ) and again on day 3 for experimental ( n = 26 ) and control ( 32 ) dogs .


Body posture , location in cage , and other behavioral parameters were recorded .


Adoption information and behavioral observation data were compared between groups .


Compared with the control group , the experimental group had a significantly greater percentage of dogs with an increase in desirable behaviors of sitting or lying down ( 17/26 [ 65 % ] vs 7/32 [ 22 % ] ) and being quiet ( 9/26 [ 35 % ] vs 4/32 [ 13 % ] ) and a significantly greater percentage of dogs with a decrease in the undesirable behavior of jumping ( 15/26 [ 57 % ] vs 3/32 [ 9 % ] ) .


Location in cage , fearfulness , and eye contact were not significantly different between groups .


Survival analysis revealed no significant difference in adoption rates between groups .


Results suggested that enrichment programs improve desirable behaviors and decrease undesirable behavior in shelter dogs , which may enhance welfare .


The investigational 9-valent viruslike particle vaccine against human papillomavirus ( HPV ) includes the HPV types in the quadrivalent HPV ( qHPV ) vaccine ( 6 , 11 , 16 , and 18 ) and five additional oncogenic types ( 31 , 33 , 45 , 52 , and 58 ) .


Here we present the results of a study of the efficacy and immunogenicity of the 9vHPV vaccine in women 16 to 26 years of age .


We performed a randomized , international , double-blind , phase 2b-3 study of the 9vHPV vaccine in 14,215 women .


Participants received the 9vHPV vaccine or the qHPV vaccine in a series of three intramuscular injections on day 1 and at months 2 and 6 .


Serum was collected for analysis of antibody responses .


Swabs of labial , vulvar , perineal , perianal , endocervical , and ectocervical tissue were obtained and used for HPV DNA testing , and liquid-based cytologic testing ( Papanicolaou testing ) was performed regularly .


Tissue obtained by means of biopsy or as part of definitive therapy ( including a loop electrosurgical excision procedure and conization ) was tested for HPV .


The rate of high-grade cervical , vulvar , or vaginal disease irrespective of HPV type ( i.e. , disease caused by HPV types included in the 9vHPV vaccine and those not included ) in the modified intention-to-treat population ( which included participants with and those without prevalent infection or disease ) was 14.0 per 1000 person-years in both vaccine groups .


The rate of high-grade cervical , vulvar , or vaginal disease related to HPV-31 , 33 , 45 , 52 , and 58 in a prespecified per-protocol efficacy population ( susceptible population ) was 0.1 per 1000 person-years in the 9vHPV group and 1.6 per 1000 person-years in the qHPV group ( efficacy of the 9vHPV vaccine , 96.7 % ; 95 % confidence interval , 80.9 to 99.8 ) .


Antibody responses to HPV-6 , 11 , 16 , and 18 were noninferior to those generated by the qHPV vaccine .


Adverse events related to injection site were more common in the 9vHPV group than in the qHPV group .


The 9vHPV vaccine prevented infection and disease related to HPV-31 , 33 , 45 , 52 , and 58 in a susceptible population and generated an antibody response to HPV-6 , 11 , 16 , and 18 that was noninferior to that generated by the qHPV vaccine .


The 9vHPV vaccine did not prevent infection and disease related to HPV types beyond the nine types covered by the vaccine .


( Funded by Merck ; ClinicalTrials.gov number , NCT00543543 ) .


Heterozygous familial hypercholesterolaemia is characterised by low cellular uptake of LDL cholesterol , increased plasma LDL cholesterol concentrations , and premature cardiovascular disease .


Despite intensive statin therapy , with or without ezetimibe , many patients are unable to achieve recommended target levels of LDL cholesterol .


We investigated the effect of PCSK9 inhibition with evolocumab ( AMG 145 ) on LDL cholesterol in patients with this disorder .


This multicentre , randomised , double-blind , placebo-controlled trial was undertaken at 39 sites ( most of which were specialised lipid clinics , mainly attached to academic institutions ) in Australia , Asia , Europe , New Zealand , North America , and South Africa between Feb 7 and Dec 19 , 2013.331 eligible patients ( 18-80 years of age ) , who met clinical criteria for heterozygous familial hypercholesterolaemia and were on stable lipid-lowering therapy for at least 4 weeks , with a fasting LDL cholesterol concentration of 26 mmol/L or higher , were randomly allocated in a 2:2:1:1 ratio to receive subcutaneous evolocumab 140 mg every 2 weeks , evolocumab 420 mg monthly , or subcutaneous placebo every 2 weeks or monthly for 12 weeks .


Randomisation was computer generated by the study sponsor , implemented by a computerised voice interactive system , and stratified by LDL cholesterol concentration at screening ( higher or lower than 41 mmol/L ) and by baseline ezetimibe use ( yes/no ) .


Patients , study personnel , investigators , and Amgen study staff were masked to treatment assignments within dosing frequency groups .


The coprimary endpoints were percentage change from baseline in LDL cholesterol at week 12 and at the mean of weeks 10 and 12 , analysed by intention-to-treat .


This trial is registered with ClinicalTrials.gov , number NCT01763918 .


Of 415 screened patients , 331 were eligible and were randomly assigned to the four treatment groups : evolocumab 140 mg every 2 weeks ( n = 111 ) , evolocumab 420 mg monthly ( n = 110 ) , placebo every 2 weeks ( n = 55 ) , or placebo monthly ( n = 55 ) .


329 patients received at least one dose of study drug .


Compared with placebo , evolocumab at both dosing schedules led to a significant reduction in mean LDL cholesterol at week 12 ( every-2-weeks dose : 592 % reduction [ 95 % CI 534-651 ] , monthly dose : 613 % reduction [ 536-690 ] ; both p < 00001 ) and at the mean of weeks 10 and 12 ( 602 % reduction [ 95 % CI 545-658 ] and 656 % reduction [ 598-713 ] ; both p < 00001 ) .


Evolocumab was well tolerated , with rates of adverse events similar to placebo .


The most common adverse events occurring more frequently in the evolocumab-treated patients than in the placebo groups were nasopharyngitis ( in 19 patients [ 9 % ] vs five [ 5 % ] in the placebo group ) and muscle-related adverse events ( ten patients [ 5 % ] vs 1 [ 1 % ] ) .


In patients with heterozygous familial hypercholesterolaemia , evolocumab administered either 140 mg every 2 weeks or 420 mg monthly was well tolerated and yielded similar and rapid 60 % reductions in LDL cholesterol compared with placebo .


Amgen Inc. .


There are high attrition rates observed in efficacy studies for social anxiety disorder , and research has not identified consistent nor theoretically meaningful predictors of dropout .


Pre-treatment symptom severity and demographic factors , such as age and gender , are sometimes predictive of dropout .


The current study examines a theoretically meaningful predictor of attrition based on experiences associated with social group membership rather than differences between social group categories -- fear of confirming stereotypes .


This is a secondary data analysis of a randomized controlled trial comparing two cognitive behavioral treatments for social anxiety disorder : virtual reality exposure therapy and exposure group therapy .


Participants ( N = 74 ) with a primary diagnosis of social anxiety disorder who were eligible to participate in the parent study and who self-identified as either `` African American '' ( n = 31 ) or `` Caucasian '' ( n = 43 ) completed standardized self-report measures of stereotype confirmation concerns ( SCC ) and social anxiety symptoms as part of a pre-treatment assessment battery .


Hierarchical logistic regression showed that greater stereotype confirmation concerns were associated with higher dropout from therapy -- race , age , gender , and pre-treatment symptom severity were not .


Group treatment also was associated with higher dropout .


These findings urge further research on theoretically meaningful predictors of attrition and highlight the importance of addressing cultural variables , such as the experience of stereotype confirmation concerns , during treatment of social anxiety to minimize dropout from therapy .


We evaluated the efficacy and safety of high-dose swallowed fluticasone propionate ( FP ) and dose reduction in patients with eosinophilic esophagitis ( EoE ) and analyzed esophageal transcriptomes to identify mechanisms .


We conducted a randomized , multisite , double-blind , placebo-controlled trial of daily 1760 mcg FP in participants age 3-30 years with active EoE .


Twenty-eight participants received FP , and 14 participants received placebo .


After 3 months , participants given FP who were in complete remission ( CR ) received 880 mcg FP daily , and participants in the FP or placebo groups who were not in CR continued or started , respectively , 1760 mcg FP daily for 3 additional months .


The primary end point was histologic evidence for CR .


Secondary end points were partial remission ( PR ) , symptoms , compliance , esophageal gene expression , esophageal eosinophil count , and the relationship between clinical features and FP responsiveness .


After 3 months , 65 % of subjects given FP and no subjects given placebo were in CR ( P = .0001 ) ; 12 % of those given FP and 8 % of those given placebo were in PR .


In the FP group , 73 % of subjects remained in CR , and 20 % were in PR after the daily dose was reduced by 50 % .


Extending FP therapy in FP-resistant participants did not induce remission .


FP decreased heartburn severity ( P = .041 ) .


Compliance , age , sex , atopic status , or anthropomorphic features were not associated with response to FP .


Gene expression patterns in esophageal tissues of FP responders were similar to those of patients without EoE ; there was evidence for heterogeneous steroid signaling in subjects who did not respond to FP and preliminary evidence for transcripts predictive of FP responsiveness .


Daily administration of a high dose of FP induces histologic remission in 65 % -77 % of patients with EoE after 3 months .


A 50 % dose reduction remained effective in 73 % -93 % of patients who initially responded to FP .


Nonresponders had evidence of steroid resistance ; histologic and molecular markers may predict resistance .


Clinicaltrials.gov number : NCT00426283 .


Falls and fall-related injuries are a serious cause of morbidity and cost to society .


Foot problems and inappropriate footwear may increase the risk of falls ; therefore podiatric interventions may play a role in reducing falls .


Two Cochrane systematic reviews identified only one study of a podiatry intervention aimed to reduce falls , which was undertaken in Australia .


The REFORM trial aims to evaluate the clinical and cost-effectiveness of a multifaceted podiatry intervention in reducing falls in people aged 65 years and over in a UK and Irish setting .


This multicentre , cohort randomised controlled trial will recruit 2600 participants from routine podiatry clinics in the UK and Ireland to the REFORM cohort .


In order to detect a 10 % point reduction in falls from 50 % to 40 % , with 80 % power 890 participants will be randomised to receive routine podiatry care and a falls prevention leaflet or routine podiatry care , a falls prevention leaflet and a multifaceted podiatry intervention .


The primary outcome is rate of falls ( falls/person/time ) over 12 months assessed by patient self-report falls diary .


Secondary self-report outcome measures include : the proportion of single and multiple fallers and time to first fall over a 12-month period ; Short Falls Efficacy Scale-International ; fear of falling in the past 4 weeks ; Frenchay Activities Index ; fracture rate ; Geriatric Depression Scale ; EuroQoL-five dimensional scale 3-L ; health service utilisation at 6 and 12 months .


A qualitative study will examine the acceptability of the package of care to participants and podiatrists .


The trial has received a favourable opinion from the East of England-Cambridge East Research Ethics Committee and Galway Research Ethics Committee .


The trial results will be published in peer-reviewed journals and at conference presentations .


Current Controlled Trials ISRCTN68240461 assigned 01/07/2011 .


For many patients with generalized anxiety disorder ( GAD ) , first-line treatment does not lead to remission .


This study investigated the efficacy and tolerability of adjunctive extended-release quetiapine fumarate ( quetiapine XR ) in patients with GAD and an inadequate response to selective serotonin reuptake inhibitors ( SSRIs ) and serotonin-norepinephrine reuptake inhibitors ( SNRIs ) .


Patients were randomized to quetiapine XR or placebo adjunctive to SSRI/SNRIs in an 11-week study .


The primary endpoint was change from randomization to week 8 in Hamilton Anxiety Rating Scale ( HAM-A ) total score .


Secondary variables were HAM-A psychic/somatic clusters , response , and remission , and Clinical Global ImpressionSeverity of Illness ( CGI-S ) score .


A total of 409 patients received quetiapine XR ( n = 209 ) or placebo ( n = 200 ) .


The week 8 mean change in HAM-A total score was not statistically significant for quetiapine XR ( 10.74 ; P = .079 ) vs placebo ( 9.61 ) .


Secondary variables were generally consistent with the primary analysis , except for a significant reduction in HAM-A total score ( week 1 ) and significant improvements in HAM-A psychic cluster and CGI-S total scores ( week 8 ) .


Adverse events included dry mouth , somnolence , sedation , headache , and dizziness .


In patients with GAD and an inadequate response to SSRI/SNRIs , adjunctive quetiapine XR did not show a statistically significant effect for the primary endpoint at week 8 , although some secondary endpoints were statistically significant vs placebo .


Quetiapine XR was generally well tolerated .


Increasing data suggest that neonatal pain has long-term consequences .


Nonpharmacologic techniques ( sucrose taste , pacifier suckling , breastfeeding ) are effective and now widely used to combat minor neonatal pain .


This study examined the analgesic effect of sucrose combined with radiant warmth compared with the taste of sucrose alone during a painful procedure in healthy full-term newborns .


A randomized , controlled trial included 29 healthy , full-term newborns born at the University of Chicago Hospital .


Both groups of infants were given 1.0 mL of 25 % sucrose solution 2 minutes before the vaccination , and 1 group additionally was given radiant warmth from an infant warmer before the vaccination .


We assessed pain by comparing differences in cry , grimace , heart rate variability ( ie , respiratory sinus arrhythmia ) , and heart rate between the groups .


The sucrose plus warmer group cried and grimaced for 50 % less time after the vaccination than the sucrose alone group ( P < .05 , respectively ) .


The sucrose plus warmer group had lower heart rate and heart rate variability ( ie , respiratory sinus arrhythmia ) responses compared with the sucrose alone group ( P < .01 ) , reflecting a greater ability to physiologically regulate in response to the painful vaccination .


The combination of sucrose and radiant warmth is an effective analgesic in newborns and reduces pain better than sucrose alone .


The ready availability of this practical nonpharmacologic technique has the potential to reduce the burden of newborn pain .


Major Depressive Disorder is one of the most challenging mental health problems of our time .


Although effective psychotherapeutic treatments are available , many patients fail to demonstrate clinically significant improvements .


Difficulties in emotion regulation have been identified as putative risk and maintaining factors for Major Depressive Disorder .


Systematically enhancing adaptive emotion regulation skills should thus help reduce depressive symptom severity .


However , at this point , no study has systematically evaluated effects of increasing adaptive emotion regulation skills application on symptoms of Major Depressive Disorder .


In the intended study , we aim to evaluate stand-alone effects of a group-based training explicitly and exclusively targeting general emotion regulation skills on depressive symptom severity and assess whether this training augments the outcome of subsequent individual cognitive behavioral therapy for depression .


In the evaluation of the Affect Regulation Training , we will conduct a prospective randomized-controlled trial .


Effects of the Affect Regulation Training on depressive symptom severity and outcomes of subsequent individual therapy for depression will be compared with an active , common factor based treatment and a waitlist control condition .


The study sample will include 120 outpatients meeting criteria for Major Depressive Disorder .


Depressive symptom severity as assessed by the Hamilton Rating Scale will serve as our primary study outcome .


Secondary outcomes will include further indicators of mental health and changes in adaptive emotion regulation skills application .


All outcomes will be assessed at intake and at 10 points in time over the course of the 15-month study period .


Measures will include self-reports , observer ratings , momentary ecological assessments , and will be complemented in subsamples by experimental investigations and the analysis of hair steroids .


If findings should support the hypothesis that enhancing regulation skills reduces symptom severity in Major Depressive Disorder , systematic emotion regulation skills training can enhance the efficacy and efficiency of current treatments for this severe and highly prevalent disorder .


This study is registered with ClinicalTrials.gov , number NCT01330485 .


This study aims to determine the long-term effects of a new Memory Self-efficacy ( MSE ) training program for stroke patients on MSE , depression , and quality of life .


In a randomized controlled trial , patients were allocated to a MSE training or a peer support group .


Outcome measures were MSE , depression , and quality of life , measured with the Metamemory-In-Adulthood questionnaire , Center for Epidemiological Studies-Depression Scale ( CES-D ) , and the Who-Qol Bref questionnaire , respectively .


We used linear mixed models to compare the outcomes of both groups immediately after training , after 6 months , and after 12 months , adjusted for baseline .


In total , 153 former inpatients from 2 rehabilitation centers were randomized-77 to the experimental and 76 to the control group .


MSE increased significantly more in the experimental group and remained significantly higher than in the control group after 6 and 12 months ( B = 0.42 ; P = .010 ) .


Psychological quality of life also increased more in the experimental group but not significantly ( B = 0.09 ; P = .077 ) .


However , in the younger subgroup of patients ( < 65 years old ) , psychological quality of life significantly improved in the experimental group compared to the control group and remained significantly higher over time ( B = 0.14 ; P = .030 ) .


Other outcome measures were not significantly different between both groups .


An MSE training program improved MSE and psychological quality of life in stroke patients aged < 65 years .


These effects persisted during 12 months of follow-up .


Non-adherence to antidepressant treatment is not routinely measured in practical clinical trials .


It has not been related to outcomes in a large sample of adults with chronic and/or recurrent major depressive disorder ( MDD ) or any sample treated with antidepressant combinations .


Adult outpatients with chronic and/or recurrent MDD were randomized to 12 weeks of treatment with bupropion-SR plus escitalopram , venlafaxine-XR plus mirtazapine , or escitalopram plus placebo .


We compared non-adherence ( the frequency with which daily medications were not taken ) and specifically the frequency of temporarily stopping and/or skipping medication , or reducing or increasing the dose across treatments in 567 participants using a self-report questionnaire collected at each visit .


We tested the association between non-adherence , and both treatment type and outcomes .


A non-adherence rate under 10 % was reported by 77.9 % , 70.9 % , and 71.6 % of participants during weeks 1-4 , 5-12 , and 1-12 , respectively .


Antidepressant combinations were associated with a higher non-adherence rate than monotherapy during weeks 1-4 and 1-12 .


During weeks 1-4 , 24.1 % stopped/skipped doses and 6.1 % reduced the dose .


During weeks 5-12 , 34.7 % stopped/skipped doses and 9.4 % reduced the dose .


Across 12 weeks , 43.2 % stopped/skipped doses , and 12.9 % reduced the dose .


Stopping/skipping doses during all time frames and dose decreases during weeks 1-12 occurred most frequently with combination treatments .


Non-adherence was unrelated to symptom remission , response , or symptom change .


With closely monitored treatment , non-adherence is low and unrelated to depressive symptom outcome .


Nonadherence is highest with antidepressant combinations .


Specific non-adherent events are most often sporadic .


Occupational quartz exposure continues to be a serious hazard in the construction industry .


Until now , evidence-based interventions aimed at reducing quartz exposure are scarce .


The aim of this study was to systematically develop an intervention and to describe the study to evaluate its effectiveness .


The intervention was developed according to the principles of the Intervention Mapping protocol , meaning that evidence from the literature was combined with information collected from stakeholders ( e.g. , construction workers , managers and researchers ) .


The intervention aimed to integrate technical , behavioural and organizational factors .


The intervention consists of two plenary meetings for all employers within the company , and individual visits at construction worksites , including specific intervention materials .


Additionally , a demonstration session regarding control measures was organized for all managers .


The effectiveness of the intervention will be evaluated in a cluster randomized controlled trial among eight construction companies , with measurements at baseline and follow-up .


Outcome measures are personal respirable dust and quartz exposure by means of exposure assessment , and behavioural and organizational determinants which will be assessed by means of questionnaires .


Additionally , a process evaluation will shed light on whether the intervention ( does not ) works , and , if so , the reasons for this .


Applying Intervention Mapping in the development of an intervention to reduce occupational quartz exposure was useful , as different stakeholders provided input for the intervention as well as the implementation strategy .


Therefore , the feasibility of the intervention has been enhanced , as it appeals to construction workers and managers and will not unduly interfere with the ongoing construction work .


NTR4586 ( May 7th 2014 ) .


To observe the effect on total liver volume ( TLV ) on and off therapy in selected symptomatic patients with autosomal dominant polycystic kidney disease ( ADPKD ) or autosomal dominant polycystic liver disease ( PLD ) who received octreotide long-acting release ( OctLAR ) for up to 4 years .


Twenty-eight of 42 participants in a prospective 2-year clinical trial of OctLAR ( 40 mg monthly ) consisting of double-blind , randomized ( year 1 ) and open-label treatment ( year 2 ) phases reenrolled in a 2-year open-label extension ( OLE ) study after being off OctLAR a mean of 8.3 months ( original study : July 1 , 2007 , through June 30 , 2013 ) .


Participants underwent magnetic resonance imaging at baseline , years 1 and 2 , reenrollment , and study completion .


Primary end point : change in TLV ; secondary end points : changes in total kidney volume , glomerular filtration rate , quality of life ( QoL ) , safety , vital signs , and laboratory parameters .