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


The groups had similar gestational ages ( @ @ weeks ) , mean birthweight ( @ @ g ) or corrected gestational age ( @ @ 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 @:@ @ vs. Group @:@ @ , p = @ ) .


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 ( @D ) 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 @D 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 .


@D LGE acquisitions were performed in @ 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 ( @ @ vs. @ @ , P = @ ) , as were blood-myocardium CGRs ( @ @ vs. @ @ , P = @ ) and blood SGRs ( @ @ vs. @ @ , P = @ ) .


The dynamic-TI algorithm improves image quality of @D 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 @ 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 @ diabetes prevention in men using an assessor-blinded , parallel-group , randomised controlled trial .


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


Eligible men were aged @-@ years , overweight/obese ( BMI @-@ kgm ( -@ ) ) and at high-risk for type @ diabetes ( score @ , Australian diabetes risk tool ) .


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


Randomisation was stratified by age ( < @ or @ years ) and BMI category ( kgm ( -@ ) : @-@ @ ; @-@ @ ; @-@ ) to the intervention or wait-list control group .


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


The primary outcome is weight change at @ months .


Secondary outcomes include : fasting plasma glucose , HbA@C , 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 , @ and @-months ) and the treatment-by-time interaction .


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


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 ) .


@ patients of all ages with suspected malaria enrolled by @ clinicians in @ 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 , @ % ( @/@ ) versus @ % ( @/@ ) of febrile patients were appropriately treated for malaria ( adjusted odds ratio @ , @ % confidence interval @ to @ , P < @ ) .


The proportion of patients who were negative for malaria and received an antibiotic was @ % ( @/@ ) in the rapid diagnostic test arm compared with @ % ( @/@ ) in the clinical diagnosis arm ( @ , @ to @ , P < @ ) .


In the comparison of rapid diagnostic test with microscopy in the moderate transmission area , @ % ( @/@ ) versus @ % ( @/@ ) of patients were appropriately treated for malaria ( @ , @ to @ , P < @ ) .


A higher proportion of P falciparum cases received appropriate treatment with artemisinin based combination therapy when malaria was diagnosed by rapid diagnostic test ( @ % , @/@ v @ % , @/@ ; @ , @ to @ , P < @ ) .


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 @ consecutive patients ( @ % females ) treated for primary hypothyroidism .


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


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 @ to March @ of women undergoing scheduled elective cesarean delivery .


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


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


Tissue-type plasminogen activator ( tPA ) , urokinase-type plasminogen activator ( uPA ) , thrombin-antithrombin complex ( TAT ) , plasminogen activator inhibitor-@ ( PAI-@ ) , and plasminogen activator inhibitor-@ ( PAI-@ ) 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 = @ .


There was a time-dependent change in tPA , uPA , and PAI-@ levels following delivery but no difference in TAT and PAI-@ 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 @ 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 > @ % 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 , @ patients ( @ IMNT and @ 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 ( @ % vs @ % , P < @ ) and protein needs ( @ vs @ % , P < @ ) 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 ( @ % vs @ % , P = @ ) .


Cox proportional hazards models indicated the hazard of death in the IMNT group was @ times higher ( P = @ ) 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 @-@ years who attended to the Department of Pediatric Dentistry for dental treatment were enrolled in the study .


Patients were randomly divided into @ groups of @ 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 @-@ , 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 < @ 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 @ ) .


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


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


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


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


We did a prespecified analysis of the ADRB@ polymorphisms Arg@Gly and Gln@Glu within the @ 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 @ 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 , rs@ ( Arg@Gly ) and rs@ ( Gln@Glu ) .


All assays were done in technical duplicates and @ % 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 @ 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 NCT@ .


@ patients gave informed consent for genotyping .


The distributions of ADRB@ genotypes were well matched among groups .


Polymorphisms at aminoacid @ did not affect exacerbation outcomes .


In the salmeterol group , patients with Arg@Arg genotype had a significantly reduced exacerbation risk compared with patients with Arg@Gly ( p = @ ) and Gly@Gly ( p = @ ) genotypes ( proportion of patients with at least one exacerbation was @ % in Arg@Arg , @ % in Arg@Gly , and @ % in Gly@Gly ) .


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


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


In patients untreated with ICS at baseline , Arg@Gly and Arg@Arg genotypes were associated with significantly prolonged time to first exacerbation compared with Gly@Gly ( vs Arg@Gly p = @ ; Arg@Arg p = @ ; proportion of patients with at least one exacerbation was @ % in Arg@Arg , @ % in Arg@Gly , and @ % in Gly@Gly ) , whereas in patients on ICS at baseline , only the Arg@Arg genotype was associated with significantly prolonged time to first exacerbation compared with Gly@Gly ( p = @ ; not Arg@Gly p = @ ; proportion of patients with at least one exacerbation was @ % in Arg@Arg , @ % in Arg@Gly , and @ % in Gly@Gly ) .


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


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


However , the use of ADRB@ 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 .


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 @ patients in our study .


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


Patients were evaluated postoperatively at @months and @year .


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 < @ were considered significant .


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


Subjective cure rates were @ % for TVT-O and @ % 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 @-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 @ and @hours post-exposure .


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


Exposure-related changes in DNA methylation were identified .


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


DNA methylation at @ 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 GSTP@ being among the significant hits .


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


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 @ 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 ( @ : @ : @ : @ ) to one of three subcutaneous secukinumab @-mg induction regimens -LSB- Single ( Week @ ) , Monthly ( Weeks @ , @ , @ ) , Early ( Weeks @ , @ , @ , @ ) -RSB- or placebo .


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


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


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


The composite fingernail score improved with the Early and Monthly regimens , but worsened with placebo -LSB- percentage mean change from baseline ( SE ) : -@ % ( @ ) and -@ % ( @ ) vs. @ % ( @ ) ; P = @ vs. placebo for Early , P = @ 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 @ year , of which @ % 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 @ 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 = @ ) or to a control group that received the usual reminder schedule only ( n = @ ) .


The primary outcome was response to the reminder questionnaire within @ days ; secondary outcomes were response to a questionnaire @ 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 @ % confidence intervals ( CI ) for both ITT and average treatment effect on the treated ( ATT ) analyses .


The proportions that responded were @ % ( @/@ ) in the intervention group compared to @ % ( @/@ ) in the control group .


The ITT estimate was a @ % increase ( @ % CI -@ to @ ) .


Four months later percentages responding were @ % ( @ ) and @ % ( @ ) .


The ITT estimate was a @ % increase ( @ % CI @ to @ ) .


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


ATT estimates adjusting for this were @ % ( @ % CI -@ to @ ) and @ % ( @ % CI @ to @ ) , respectively .


The telephone call resulted in a slight increase in response to the reminder questionnaire , however at @ 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 .


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 ( N@O ) in the inspired gas mixture during @-lung ventilation would lead to clinically relevant improvement of lung collapse during subsequent @-lung ventilation with a bronchial blocker .


Fifty patients were randomized into @ groups : N@O ( n = @ ) or O@ ( n = @ ) .


The N@O group received a gas mixture of oxygen and N@O ( FIO@ = @ ) , and the O@ group received @ % oxygen until the start of @-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 @ % oxygen during @-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 , @ = no collapse to @ = complete collapse ) at @ minutes after opening the pleura .


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


The score on the lung collapse scale in the N@O group was significantly higher compared with the O@ group at @ minutes after opening the pleura ( @ vs @ , P < @ , WMWodds = @ , @ % confidence interval ( CI ) , @ to @ ) .


It was also higher in the N@O group at @ minutes ( @ vs @ , P < @ , WMWodds = @ , @ % CI , @-@ @ ) .


The lung collapse scale between groups was not significant at @ minute after opening the pleura ( @ vs @ , P = @ , WMWodds = @ , @ % CI , @-@ @ ) .


None of the patients developed hypoxia ( SpO@ < @ % ) during @-lung ventilation .


Filling the lung with @ % N@O before @-lung ventilation facilitated lung collapse @ minutes after opening the chest compared with @ % oxygen when a bronchial blocker was used .


The N@O/O@ mixture ( FIO@ = @ ) did not have a harmful effect on subsequent arterial oxygenation during @-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 @ patients with AF and stable coronary heart disease older than @ years were randomized into two groups .


One group ( n = @ ) basically received @ mg/day warfarin per os , followed by addition of @ - @ mg/day from day @ - @ if the international normalized ratio ( INR ) was initially < @ and in order to achieve a maintained INR between @ and @ ( warfarin group ) .


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


All patients were medicated and monitored for a period of @ 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 @ years of medication ( @ % vs. @ % , p = @ ) , while there was no significant difference of mild ( @ vs. @ ) , severe ( @ vs. @ ) , and fatal ( @ vs. @ ) hemorrhage incidences between the warfarin and aspirin groups ( p > @ ) .


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 @ % 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 , @-@ years ) having bilateral photorefractive keratectomy for myopic correction with or without astigmatism .


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


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


Case group was administered the diclofenac @ % drop , one drop @h preoperatively and four times daily postoperatively for @ 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 < @ ) .


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 @:@:@ into @ of @ groups based on the induction sequence : ( @ ) every @ weeks for @ consecutive injections ; ( @ ) every @ weeks for @ consecutive injections ; and ( @ ) 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 @ patients ( @ eyes ) .


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


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


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


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


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 @ per second and @ 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 NCT@ , first-line gefitinib @ 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 ( @ and @ ) baseline samples were collected ( all screened patients ; n = @ ) .


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 @ of @ ( @ positive of @ mutation status known ; mutation frequency , @ % ) .


Available plasma @ samples were @ of @ ( @ positive of @ mutation status known ; mutation frequency , @ % ) .


Mutation status concordance between @ matched tumor and plasma @ samples was @ % ( @ % confidence interval -LSB- CI -RSB- , @-@ @ ) ( comparable for mutation subtypes ) ; test sensitivity was @ % ( @ % CI , @-@ @ ) ; and test specificity was @ % ( @ % CI , @-@ @ ) .


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


Available plasma @ samples were @ of @ ( @ positive of @ mutation status-evaluable and - known ) .


Mutation status concordance between @ matched duplicate plasma @ and @ samples was @ % ( @ % CI , @-@ @ ) .


Objective response rates are as follows : mutation-positive tumor , @ % ( @ % CI , @-@ @ ) ; mutation-positive tumor and plasma @ , @ % ( @ % CI , @-@ @ ) ; and mutation-positive tumor and mutation-negative plasma @ , @ % ( @ % CI , @-@ @ ) .


Median progression-free survival ( months ) was @ ( @ % CI , @-@ @ ; @ events ) for mutation-positive tumor and @ ( @ % CI , @-@ @ ; @ events ) for mutation-positive tumor and plasma @ .


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 @ to October @ , @ , @ CHWs conducted door-to-door interviews of women aged @ 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 @ months , @,@ women were interviewed ; < @ % declined participation , and @ 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 @ patients ) by using a series of random numbers : group A received ketoprofen @ mg and group B received diclofenac @ mg , all intramuscularly .


Surgery was done @ 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 @ 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 @ mg is more effective than intramuscular diclofenac @ mg after mandibular third molar extraction when used as a preemptive analgesic .


The @-item Multiple Sclerosis Impact Scale ( MSIS-@ ) 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-@ 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-@ .


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


Distribution-based RD estimates ranged from @ to @ .


An RD of @ 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 @ point worsening on the MSIS-@ 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 @ 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 = @ ) .


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 @ % ( understanding the conceptual framework ) and @ % ( 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-@a ( 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 @b dose-ranging study in patients chronically infected with HCV genotypes @-@ .


Treatment-naive patients received Lambda ( @/@/@ g ) or peginterferon alfa-@a ( alfa ; @ g ) once-weekly with ribavirin for @ ( genotypes -LSB- GT -RSB- @,@ ) or @ ( GT@ ,@ ) weeks .


Rates of undetectable HCV-RNA at week @ ( complete early virologic response -LSB- cEVR -RSB- ; primary end point ) were significantly higher in GT@ ,@ patients receiving Lambda vs. alfa ( @/@ , @ % vs. @/@ , @ % ) ; with similar cEVR rates for GT@ ,@ ( @/@ , @ % vs. @/@ , @ % ) .


Rates of undetectable HCV-RNA at week @ were significantly higher on @ g ( @/@ , @ % GT@ ,@ ; @/@ , @ % GT@ ,@ ) and @ g ( @/@ , @ % GT@ ,@ ; @/@ , @ % GT@ ,@ ) Lambda than alfa ( @/@ , @ % GT@ ,@ ; @/@ , @ % GT@ ,@ ) .


Sustained virologic responses ( post-treatment week @ ) were comparable between Lambda and alfa for GT@ ,@ ( @-@ % Lambda ; @ % alfa ) and GT@ ,@ ( @-@ % Lambda ; @ % alfa ) .


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


Serious adverse events were comparable ( @-@ % Lambda ; @-@ % alfa ) .


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


Among alfa patients , @/@ ( @ % ) had peginterferon and @/@ ( @ % ) had ribavirin dose reductions for haematologic abnormalities vs. @/@ and @/@ ( @ % ) on Lambda .


Lambda demonstrated fewer musculoskeletal ( @-@ % vs. @-@ % ) and influenza-like events ( @-@ % vs. @-@ % ) 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 @ cartilage areas .


For the detection of cartilage lesions , flat-panel CT showed a sensitivity of @ % , specificity of @ % , and accuracy of @ % , and MDCT arthrography showed a sensitivity of @ % , specificity of @ % , and accuracy of @ % .


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


Radiation dose was significantly lower for flat-panel CT ( mean , @ mGy ; range , @-@ @ mGy ) than for MDCT ( mean , @ mGy ; range , @-@ @ mGy ) ( p < @ ) .


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 @ 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 @ % or more body weight by year @ .


Data consisting of month @ , @ , @ , and @ treatment weights were obtained from the @-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 @ , @ , and @ that predicted the probability of losing < @ % of body weight in @ 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 < @ % of their body weight at the end of @ 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 @ , @ , and @ yielded ROC curves with AUCs of @ ( @ % CI : @ , @ ) , @ ( @ % CI : @ , @ ) , and @ ( @ % CI : @ , @ ) , respectively .


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


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 @ points in the plate group and @ points in the nail group ( p = @ ) .


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


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


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 = @ ) .


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 @ with RA were enrolled in a @-month controlled trial ( approval no. @/@ - 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 @ patients with SSc and @ 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 @ and @ 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 < @ ) but the HAQ ( p = @ ) and the HAMIS test ( right hand p = @ , left hand p = @ ) improved significantly only in the experimental arm .


Patients with RA showed a statistically significant improvement of FIHOA ( p = @ ) and HAQ ( p = @ ) 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 @ % ; RA @ % ) than in experimental arms ( SSc @ % ; RA @ % ) .


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 @ patients with a mean age of @ 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 @ years ( @-@ @ ) follow-up .


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


This resulted in @ patients with a mobile-bearing knee and @ 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 @ September @ and @ February @ .


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


A @-week washout period separated study periods .


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


A total of @ % of the CD calories came from carbohydrates and @ % from fat , whereas for the PD , these percentages were @ and @ % , respectively ( including @ 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 @ significantly decreased under the PD compared with the CD ( P < @ ) , whereas glucagon-like peptide-@ increased .


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


SLC@A@ expression increased by @ % in CD ( P = @ , for PD vs. CD ) .


Cellular glucose uptake by lymphocytes decreased by @ % during the PD ( P = @ , 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 .


@ dogs .


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


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 @ ( first day on adoption floor ) and again on day @ for experimental ( n = @ ) and control ( @ ) 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 ( @/@ -LSB- @ % -RSB- vs @/@ -LSB- @ % -RSB- ) and being quiet ( @/@ -LSB- @ % -RSB- vs @/@ -LSB- @ % -RSB- ) and a significantly greater percentage of dogs with a decrease in the undesirable behavior of jumping ( @/@ -LSB- @ % -RSB- vs @/@ -LSB- @ % -RSB- ) .


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 @-valent viruslike particle vaccine against human papillomavirus ( HPV ) includes the HPV types in the quadrivalent HPV ( qHPV ) vaccine ( @ , @ , @ , and @ ) and five additional oncogenic types ( @ , @ , @ , @ , and @ ) .


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


We performed a randomized , international , double-blind , phase @b-@ study of the @vHPV vaccine in @,@ women .


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


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 @vHPV vaccine and those not included ) in the modified intention-to-treat population ( which included participants with and those without prevalent infection or disease ) was @ per @ person-years in both vaccine groups .


The rate of high-grade cervical , vulvar , or vaginal disease related to HPV-@ , @ , @ , @ , and @ in a prespecified per-protocol efficacy population ( susceptible population ) was @ per @ person-years in the @vHPV group and @ per @ person-years in the qHPV group ( efficacy of the @vHPV vaccine , @ % ; @ % confidence interval , @ to @ ) .


Antibody responses to HPV-@ , @ , @ , and @ were noninferior to those generated by the qHPV vaccine .


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


The @vHPV vaccine prevented infection and disease related to HPV-@ , @ , @ , @ , and @ in a susceptible population and generated an antibody response to HPV-@ , @ , @ , and @ that was noninferior to that generated by the qHPV vaccine .


The @vHPV 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 , NCT@ ) .


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 PCSK@ inhibition with evolocumab ( AMG @ ) on LDL cholesterol in patients with this disorder .


This multicentre , randomised , double-blind , placebo-controlled trial was undertaken at @ 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 @ and Dec @ , @ eligible patients ( @-@ years of age ) , who met clinical criteria for heterozygous familial hypercholesterolaemia and were on stable lipid-lowering therapy for at least @ weeks , with a fasting LDL cholesterol concentration of @ mmol/L or higher , were randomly allocated in a @:@:@:@ ratio to receive subcutaneous evolocumab @ mg every @ weeks , evolocumab @ mg monthly , or subcutaneous placebo every @ weeks or monthly for @ 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 @ 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 @ and at the mean of weeks @ and @ , analysed by intention-to-treat .


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


Of @ screened patients , @ were eligible and were randomly assigned to the four treatment groups : evolocumab @ mg every @ weeks ( n = @ ) , evolocumab @ mg monthly ( n = @ ) , placebo every @ weeks ( n = @ ) , or placebo monthly ( n = @ ) .


@ 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 @ ( every-@-weeks dose : @ % reduction -LSB- @ % CI @-@ -RSB- , monthly dose : @ % reduction -LSB- @-@ -RSB- ; both p < @ ) and at the mean of weeks @ and @ ( @ % reduction -LSB- @ % CI @-@ -RSB- and @ % reduction -LSB- @-@ -RSB- ; both p < @ ) .


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 @ patients -LSB- @ % -RSB- vs five -LSB- @ % -RSB- in the placebo group ) and muscle-related adverse events ( ten patients -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


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


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 = @ ) 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 = @ ) or `` Caucasian '' ( n = @ ) 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 @ mcg FP in participants age @-@ years with active EoE .


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


After @ months , participants given FP who were in complete remission ( CR ) received @ mcg FP daily , and participants in the FP or placebo groups who were not in CR continued or started , respectively , @ mcg FP daily for @ 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 @ months , @ % of subjects given FP and no subjects given placebo were in CR ( P = @ ) ; @ % of those given FP and @ % of those given placebo were in PR .


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


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


FP decreased heartburn severity ( P = @ ) .


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 @ % -@ % of patients with EoE after @ months .


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


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


Clinicaltrials.gov number : NCT@ .


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 @ years and over in a UK and Irish setting .


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


In order to detect a @ % point reduction in falls from @ % to @ % , with @ % power @ 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 @ 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 @-month period ; Short Falls Efficacy Scale-International ; fear of falling in the past @ weeks ; Frenchay Activities Index ; fracture rate ; Geriatric Depression Scale ; EuroQoL-five dimensional scale @-L ; health service utilisation at @ and @ months .


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


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 @-week study .


The primary endpoint was change from randomization to week @ 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 @ patients received quetiapine XR ( n = @ ) or placebo ( n = @ ) .


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


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


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 @ , 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 @ healthy , full-term newborns born at the University of Chicago Hospital .


Both groups of infants were given @ mL of @ % sucrose solution @ minutes before the vaccination , and @ 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 @ % less time after the vaccination than the sucrose alone group ( P < @ , 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 < @ ) , 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 @ 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 @ points in time over the course of the @-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 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 @ months , and after @ months , adjusted for baseline .


In total , @ former inpatients from @ rehabilitation centers were randomized-@ to the experimental and @ to the control group .


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


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


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


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 < @ years .


These effects persisted during @ 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 @ 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 @ 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 @ % was reported by @ % , @ % , and @ % of participants during weeks @-@ , @-@ , and @-@ , respectively .


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


During weeks @-@ , @ % stopped/skipped doses and @ % reduced the dose .


Across @ weeks , @ % stopped/skipped doses , and @ % reduced the dose .


Stopping/skipping doses during all time frames and dose decreases during weeks @-@ 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 .


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 @ years .


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


Participants underwent magnetic resonance imaging at baseline , years @ and @ , 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 .


Twenty-five participants ( @ % ) completed the OLE .


Off therapy , TLVs increased a mean SD of @ % @ % per year ; after resuming therapy , TLVs decreased a mean SD of -@ % @ % per year .


Despite regrowth off treatment , overall reductions were observed , with a median ( interquartile range ) TLV of @ mL ( @-@ mL ) at baseline and @ ( @-@ mL ) at study completion ( -@ % ; P < @ ) and with improved health-related QoL .


Total kidney volumes increased , and glomerular filtration rates declined from @ mL/min to @ mL/min ( n = @ ) in patients with ADPKD on therapy from baseline to study completion .


Therapy with OctLAR over @ years in selected patients with symptomatic PLD arrested PLD progression , alleviating symptoms and improving health-related QoL .


Discontinuation led to organ regrowth .


The best suture method to prevent incisional surgical-site infection ( SSI ) after clean-contaminated surgery has not been clarified .


Patients undergoing elective colorectal cancer surgery at one of @ centres were randomized to receive either subcuticular sutures or skin stapling for skin closure .


The primary endpoint was the rate of incisional SSI .


Secondary endpoints of interest included time required for wound closure , incidence of wound problems , postoperative length of stay , wound aesthetics and patient satisfaction .


A total of @ patients were enrolled .


The cumulative incidence of incisional SSI by day @ after surgery was similar after subcuticular sutures and stapled closure ( @ versus @ per cent respectively ; P = @ ) .


Comparison of cumulative incidence curves revealed that SSI occurred later in the subcuticular suture group ( P = @ ) ( hazard ratio @ , @ per cent c.i. @ to @ ) .


Wound problems ( P = @ ) , wound aesthetics ( P = @ ) and postoperative duration of hospital stay ( P = @ ) did not differ between the groups ; subcuticular sutures took @min longer than staples ( P < @ ) .


Patients in the subcuticular suture group were significantly more satisfied with their wound ( @ per cent versus @ per cent in the staple group ; P = @ ) .


Compared with skin stapling , subcuticular sutures did not reduce the risk of incisional SSI after colorectal surgery .


Chronic prostatitis displays a variety of symptoms ( mainly local pain exhibiting variability in origin and intensity ) .


The purpose of this article is to briefly present the preliminary results of our study examining the role of phytotherapeutic agents in the treatment of chronic prostatitis patients .


The study included in total fifty-six consecutive patients who visited the outpatient department .


Subjects were randomized into two groups .


Subjects in the first group ( @ patients ) received prulifloxacin @ mg for @ days , while subjects in the second group ( @ patients ) received prulifloxacin @ mg for @ days and Serenoa repens extract for @ weeks .


The response was tested using laboratory and clinical criteria .


We found statistically significant differences between the two groups regarding pain regression and no statistically significant regarding bacterial eradication .


Moreover however while sexual dysfunction improvement was equally achieved in both groups , improvement of urinary symptoms was more evident in the @nd group especially after the completion of the antibiotic treatment .


Serenoa repens extract for @ weeks seems to improve prostatitis related pain .


Further randomized , placebo-controlled studies are needed to substantiate safer conclusions .


This study aims to identify the optimal mini-invasive treatment for extrahepatic bile duct stones .


One hundred and seventy eight patients with EHBD stones were randomized into @ groups : laparoscopic cholecystectomy ( LC ) and laparoscopic common bile duct exploration ( LCBDE ) plus T-tube drainage ( group LT ) , LC and LCBDE with endonasobiliary drainage ( ENBD ) tube ( group LE ) , and endoscopic sphincterotomy with ENBD followed by LC ( group EE ) and T-tube drainage of open CBDE ( group OT ) .


Demographic data , perioperative findings , postoperative outcomes , hospital expense , gastrointestinal quality of life index ( GIQLI ) scores and cost per quality-adjusted life year ( QALY ) were analyzed .


The operating time was longest in group EE .


There was less bleeding in group OT and EE .


Group LE and EE had shorter hospital stay and recovery time of intestinal motility .


The postoperative white blood cell count and serum C-reaction protein level were higher in group LT and OT .


Postoperatively , the mean GIQLI scores in group LE and EE were higher .


Mean cost were highest in group EE .


Patients in group LE had lowest cost per QALY .


The modified laparoscopic procedure , LC combined with LCBDE followed by a primary closure over the ENBD tubes , appears to be the best option for patients with EHBD stones .


Because of the restrictions applied to the conduct of randomized clinical trials , the risks reported in their comparison of open and endovascular aneurysm repair ( EVAR ) of abdominal aortic aneurysms ( AAA ) may not be applicable to real-world vascular surgical practice .


The magnitude of this deviation is indeterminate .


To compare @-day mortality from the recent Open Vs Endovascular Repair ( OVER ) Veterans Affairs Cooperative trial with results obtained from the American College of Surgeons National Surgical Quality Improvement Program ( NSQIP ) and to assess temporal trends in perioperative mortality .


We analyzed data from @,@ patients who received elective EVAR or open repair for asymptomatic infrarenal AAA between January @ , @ , and December @ , @ , in the NSQIP database .


We used @ and t tests to compare perioperative mortality between groups .


Logistic regression was used to analyze perioperative mortality , adjusting for age , sex , race , and comorbidities .


The outcomes of the OVER trial were then compared with the national estimates obtained from the NSQIP .


Death within @ days of surgery .


Perioperative mortality was @ % ( @ % CI , @ % -@ % ) after open repair and @ % ( @ % CI , @ % -@ % ) after EVAR .


There was a @ % reduction in operative mortality after EVAR compared with open repair ( adjusted odds ratio -LSB- aOR -RSB- , @ ; @ % CI , @-@ @ ; P < @ ) .


Mortality was significantly lower in men compared with women ( aOR , @ ; @ % CI , @-@ @ ; P = @ ) .


Thirty-day mortality in the NSQIP cohort was higher than that reported in the OVER trial for both EVAR and open repair ( EVAR , @ % vs @ % ; open , @ % vs @ % ) .


There was an increase in the proportion of patients who received EVAR during the @ years studied ( @ % in @ and @ % in @ ) .


There has been no significant decrease in perioperative mortality during these years ( P > @ ) .


Perioperative mortality reported by the OVER trial is significantly lower than outcomes from practices outside the restriction of randomized clinical trials .


We attribute this difference to the fact that the OVER trial excluded high-risk patients deemed unfit for open repair .


This finding supports the need for individualized assessment of risk and treatment selection for patients with infrarenal AAA .


There has been no change in perioperative mortality after EVAR in recent years despite improvements in techniques , devices , and proficiency .


We hypothesized that immediate laparoscopic surgery for appendiceal abscess would result in faster recovery than conservative treatment .


On the basis of the retrospective studies , conservative management of appendiceal abscess is recommended as a first line treatment , but some controversy exists .


Sixty adult patients diagnosed with appendiceal abscess were randomly assigned to either laparoscopic surgery ( n = @ ) or conservative treatment ( n = @ ) .


Hospital stay , recurrences , additional interventions , and complications within @ days from randomization were recorded .


There was no difference in hospital stay : @ days ( interquartile range : @-@ days ) in the laparoscopy group versus @ days ( @-@ ) in the conservative group , P = @ .


Patients in the laparoscopy group had @ % risk for bowel resection and @ % risk for incomplete appendectomy .


There were significantly fewer patients with unplanned readmissions in the laparoscopy group : @ ( @ % ) versus @ ( @ % ) , P = @ .


Additional interventions were required in @ ( @ % ) patients in the laparoscopy group ( percutaneous drainage ) and in @ ( @ % ) patients in the conservative group ( surgery ) , P = @ .


Recurrent abscesses and failure to respond to conservative treatment were the main reasons for additional interventions .


Open surgery was required in @ ( @ % ) patients in the laparoscopy group and in @ ( @ % ) patients in the conservative group .


Postoperative complications occurred in @ patients in laparoscopic group versus @ patients in the conservative group .


The rate of uneventful recovery was @ % in the laparoscopy group versus @ % in the conservative group , P = @ .


Laparoscopic surgery in experienced hands is safe and feasible first-line treatment for appendiceal abscess .


It is associated with fewer readmissions and fewer additional interventions than conservative treatment with comparable hospital stay .


Home and community-based combined treatment of malaria and pneumonia has been promoted in Uganda since mid @ .


The combined treatment is justified given the considerable overlap between the symptoms of malaria and pneumonia among infants .


There is limited evidence about the extent to which community-based care reduces healthcare-seeking costs at the household level in rural and urban settings .


This paper assesses the rural-urban differences in direct and indirect costs of seeking care from formal health facilities compared to community medicine distributors ( CMDs ) .


Exit interviews were conducted for @ ( @ rural and @ urban ) caregivers of children below five years who had received treatment for fever-related illnesses at selected health centres in Iganga and Mayuge districts .


Data on the direct and indirect costs incurred while seeking care at the health centre visited were obtained .


Using another tool , household level direct and indirect costs of seeking care from CMDs were collected from a total of @ caregivers ( @ rural and @ urban ) .


Costs incurred at health facilities were then compared with costs of seeking care from CMDs .


Household direct costs of seeking care from health facilities were significantly higher for urban-based caregivers than the rural ( median cost = US$ @ for urban and zero for rural ; p < @ ) .


The same is true for seeking care from CMDs ( p = @ ) .


Overall , caregivers travelled for an average of @min to reach health centres and spent an average of @min at the health centre while receiving treatment .


However , households in rural areas travelled for a significantly longer time ( p < @ to reach health care facilities than the urban-based caregivers .


Besides travelling longer distances , rural caregivers spent @min seeking care from health facilities compared to @min from CMDs .


Time and monetary savings for seeking care from CMDs are significantly larger for rural than urban households .


Thus , home and community-based treatment of child febrile illnesses is much more cost-saving for rural poor communities , who would spend more time travelling to health facilities - which time could be re-directed to productive and income-generating activities .


Use of pretest probability can reduce unnecessary testing .


We hypothesize that quantitative pretest probability , linked to evidence-based management strategies , can reduce unnecessary radiation exposure and cost in low-risk patients with symptoms suggestive of acute coronary syndrome and pulmonary embolism .


This was a prospective , @-center , randomized controlled trial of decision support effectiveness .


Subjects were adults with chest pain and dyspnea , nondiagnostic ECGs , and no obvious diagnosis .


The clinician provided data needed to compute pretest probabilities from a Web-based system .


Clinicians randomized to the intervention group received the pretest probability estimates for both acute coronary syndrome and pulmonary embolism and suggested clinical actions designed to lower radiation exposure and cost .


The control group received nothing .


Patients were followed for @ days .


The primary outcome and sample size of @ was predicated on a significant reduction in the proportion of healthy patients exposed to > @ mSv chest radiation .


A total of @ patients were randomized , and @ had complete data .


The proportion with > @ mSv to the chest and no significant cardiopulmonary diagnosis within @ days was reduced from @ % to @ % ( P = @ ) .


The intervention group had significantly lower median chest radiation exposure ( @ versus @ mSv ; P = @ , Mann-Whitney U test ) and lower median costs ( $ @ versus $ @ ; P = @ ) for medical care .


Adverse events occurred in @ % of controls and @ % in the intervention group ( P = @ ) .


Provision of pretest probability and prescriptive advice reduced radiation exposure and cost of care in low-risk ambulatory patients with symptoms of acute coronary syndrome and pulmonary embolism .


To evaluate vasopressin vs dopamine as initial therapy in extremely low birth weight ( ELBW ) infants with hypotension during the first @ hours of life .


ELBW infants with hypertension @ weeks ' gestation and @ hours old randomly received treatment with vasopressin or dopamine in a blinded fashion .


Normotensive infants not receiving vasopressor support served as a comparison group .


Twenty ELBW infants with hypertension received vasopressin ( n = @ ) or dopamine ( n = @ ) , and @ were enrolled for comparison .


Mean gestational age was @ @ weeks and birth weight @ @ g. Response to vasopressin paralleled that of dopamine in time to adequate mean blood pressure ( Kaplan-Meier curve , P = @ ) ; @ % of infants in each treatment group responded with adequate blood pressure .


The vasopressin group received fewer doses of surfactant ( P < @ ) , had lower PaCO@ values ( P < @ ) , and were not tachycardic ( P < @ ) during vasopressin administration , compared with the dopamine group .


Vasopressin in ELBW infants as the initial agent for early hypotension appeared safe .


This pilot study supports a larger randomized controlled trial of vasopressin vs dopamine therapy in ELBW infants with hypotension .


Approximately @ % to @ % of asthmatic patients achieve incomplete symptom control on current therapies .


The association of IL-@ with asthma pathology and reduced corticosteroid sensitivity suggests a potential benefit of anti-IL-@ therapy in refractory asthma .


GSK@ , a humanized mAb , inhibits IL-@ binding to both IL-@ receptor @ and @ .


We sought to evaluate the efficacy and safety of GSK@ in patients with severe asthma refractory to maximally indicated doses of inhaled corticosteroids .


Patients who remained symptomatic ( Asthma Control Questionnaire score @ ) after uptitration to @ g/d fluticasone propionate or greater were randomized to @ once-monthly intravenous infusions of @ mg/kg GSK@ ( n = @ ) or placebo ( n = @ ) .


Treatment differences in adjusted mean change from baseline over @ weeks were nonsignificant for Asthma Control Questionnaire symptom scores ( the primary end point ; GSK@ = -@ , placebo = -@ , P = @ ) and FEV ( GSK@ = -@ , placebo = @ , P = @ ) .


Similar analyses in patients with increased serum IgE levels , blood eosinophil counts , or both were also negative .


Incidence of asthma exacerbations was similar between treatments .


Most adverse events were nonserious and unrelated to treatment .


Two GSK@-treated patients had treatment-related serious adverse events ( lethargy and supraventricular extrasystoles ) .


Although well tolerated , GSK@ did not demonstrate clinically meaningful improvements in asthma control , pulmonary function , or exacerbations in patients with severe asthma .


Further studies are needed to determine whether therapies targeting IL-@ , the functionally related IL-@ cytokine , or both can provide clinical benefit in patients with severe refractory asthma or a subpopulation of these patients beyond that achievable with high-dose corticosteroids .


Gold standard treatment for symptomatic gall stones is laparoscopic cholecystectomy ( LC ) .


Ultrasonically activated devices have been used for gall bladder dissection in LC .


Harmonic scalpel ( HS ) is the leading ultrasonically cutting coagulation device offering surgeons important benefits .


The main aim of our study was to compare the surgical outcomes of LC performed by HS to that performed by conventional mono-polar diathermy ( electro-cautery ) .


This prospective randomized study was conducted in surgical department of Jinnah Postgraduate Medical Centre , Karachi , during May-October @ .


During this period we selected @ patients with symptomatic gallstones who underwent LC ; these patients were randomly recruited into two groups using sealed opaque envelopes .


Group A underwent gallbladder dissection from its bed using mono-polar diathermy , while on the other hand in Group B the dissection was carried out using harmonic scalpel .


The outcomes like gallbladder perforation with bile spillage , intra-operative bleeding and operative time were assessed .


The harmonic scalpel ( HS ) usage in surgery results in shorter operative time , it also leads to less gallbladder injury , bile leakage and stone spillage ( due to minimal lateralization of heat energy ) not only this it also leads to less intra-operative blood loss .


Harmonic scalpel is a new innovation in gallbladder surgery it has multiple functions like cutting , coagulation , coaptaion and cavitation which have made it safe , handy , effective and reliable instrument .


The main objective of the present analysis was to assess the effect of treatment with aspirin compared with apixaban on ischemic stroke and major bleeding in women compared with men .


Female patients with atrial fibrillation are at increased stroke risk compared with male patients , and the underlying reasons for higher risk are uncertain .


Ancillary analysis of the Apixaban Versus Acetylsalicylic Acid -LSB- ASA -RSB- to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment ( AVERROES ) trial , comparing aspirin and apixaban , focused on sex differences .


Mean follow-up was @ years .


Women compared with men tended to be older ( aspirin , @ versus @ years ; apixaban , @ versus @ years ) , with a higher proportion of those aged@ years .


Also , women had less peripheral artery disease ( aspirin , @ % versus @ % ; apixaban , @ % versus @ % ) , more heart failure , and higher mean CHADS@ ( congestive heart failure , hypertension , age of @ years or older , diabetes -LSB- @ point each -RSB- , stroke or transient ischemic attack -LSB- @ points -RSB- ) scores ( aspirin , @ versus @ ; apixaban , @ versus @ ) .


Women compared with men had higher ischemic stroke rates ( aspirin , @ % versus @ % ; apixaban , @ % versus @ % ) but similar bleeding rates ( aspirin , @ % versus @ % ; apixaban , @ % versus @ % ) .


The relative effect of apixaban compared with aspirin was similar in men and women for both ischemic stroke ( women , @ % versus @ % ; hazard ratio , @ ; @ % confidence interval , @-@ @ ; men , @ % versus @ % ; hazard ratio , @ ; @ % confidence interval , @-@ @ ; Pint = @ ) and major bleeding ( women , @ % versus @ % ; hazard ratio , @ ; @ % confidence interval , @-@ @ ; men , @ % versus @ % ; hazard ratio , @ ; @ % confidence interval , @-@ @ ; Pint = @ ) .


Female patients with atrial fibrillation had higher ischemic stroke rates compared with male patients , but the relative effects of apixaban compared with aspirin on both ischemic stroke and bleeding were similar in men and women .


Magnetic resonance imaging ( MRI ) of patients with conventional implantable cardioverter-defibrillators ( ICD ) is contraindicated .


This multicenter , randomized trial evaluated safety and efficacy of a novel ICD system specially designed for full-body MRI without restrictions on heart rate or pacing dependency .


The primary safety objective was > @ % freedom from MRI-related events composite endpoint within @ days post-MRI .


The primary efficacy endpoints were ventricular pacing capture threshold and ventricular sensing amplitude .


Subjects received either a single - or dual-chamber ICD .


In a @:@ randomization , subjects either underwent MRIat @-T of the chest , cervical , and head regions to maximize radiofrequency exposure up to @ W/kg specific absorption rate and gradient field exposure to @ T/m/s per axis ( MRI group , n = @ ) , or they underwent a @-h waiting period without MRI ( control group , n = @ ) .