128 patients with primary diagnosis of OCD according to DSM-IV and no or only partial response to CBT will be recruited from in - and outpatient services as well as online forums and the media .


Patients will be randomized to either an MBCT intervention group or to a psycho-educative coaching group ( OCD-EP ) as an active control condition .


All participants will undergo eight weekly sessions with a length of 120 minutes each of a structured group program .


We hypothesize that MBCT will be superior to OCD-EP in reducing obsessive-compulsive symptoms as measured by the Yale-Brown-Obsessive-Compulsive Scale ( Y-BOCS ) following the intervention and at 6 - and 12-months-follow-up .


Secondary outcome measures include depressive symptoms , quality of life , metacognitive beliefs , self-compassion , mindful awareness and approach-avoidance tendencies as measured by an approach avoidance task .


The results of this study will elucidate the benefits of MBCT for OCD patients who did not sufficiently benefit from CBT .


To our knowledge , this is the first randomized controlled study assessing the effects of MBCT on symptom severity and associated parameters in OCD .


German Clinical Trials Register DRKS00004525 .


Registered 19 March 2013 .


Blond and white hair removal by laser is a complicated task with weak satisfactory results due to the deficiency in laser-absorbing chromophore .


To investigate if repetitive sessions of photodynamic therapy ( PDT ) using external application of liposomal Rose bengal ( RB ) photosensitizer followed by intense pulsed light ( IPL ) exposure enables removal of gray and white hair .


Rose bengal loaded in liposomes ( LRB ) was constructed , prepared in hydrogel , and was studied for some pharmaceutical properties .


Penetration and selective hair follicle damage in mice skin were studied .


Topical gel containing LRB was used for treating fifteen adult females who were complaining of facial white terminal hair .


Unwanted facial hair was treated for three sessions at intervals of 4-6 weeks using intense pulsed light ( IPL ) .


At each session , the treatment area was pre-treated with topical LRB gel , while a control group of another 15 patients applied placebo gel before IPL treatment .


Evaluations included hair regrowth , which was measured 4 weeks after each treatment session and at 6 months follow-up by counting the number of terminal hair compared with baseline pretreatment values .


Treatment outcomes and complications if any were also reported .


Average hair regrowth in the LRB group was 56 % after 3 treatment cycles .


After six-months follow up , average terminal hair count compared with baseline pretreatment showed 40 % reduction and no recorded side effects .


A significant difference ( P < 0.05 ) was seen compared with the control group ; the clinical results were promising .


Photodynamic hair removal using rose bengal-encapsulated liposomal gel in combination with IPL treatment showed significant efficacy in the treatment of white hair compared with a control group .


Limited data describe patient-reported outcomes ( PROs ) of localised oesophageal cancer treated with definitive chemoradiotherapy ( CRT ) .


The phase 2/3 SCOPE-1 trial assessed the effectiveness of CRTcetuximab .


The trial for the first time provided an opportunity to describe PROs from a multi-centre group of patients treated with CRT that are presented here .


Patients undergoing CRTcetuximab within the SCOPE-1 trial ( 258 patients from 36 UK centres ) completed generic - , disease - and treatment-specific health-related quality of life ( HRQL ) questionnaires ( EORTC QLQ-C30 , QLQ-OES18 , Dermatology Life-Quality Index ( DLQI ) ) at baseline and at 7 , 13 , 24 , 52 and 104 weeks .


Mean EORTC functional scale scores ( > 15 point change significant ) , DLQI scores ( > 4 point change significant ) and proportions of patients ( > 15 % significant ) with ` minimal ' or ` severe ' symptoms are presented .


Questionnaire response rates were good .


At baseline , EORTC functional scores were high ( > 75 % ) and few symptoms were reported except for severe problems with fatigue , insomnia and eating-related symptoms ( e.g. , appetite loss , dysphagia , dry mouth ) in both groups ( > 15 % ) .


Functional aspects of health deteriorated and symptoms increased with treatment and by week 13 global quality of life , physical , role and social function significantly deteriorated and more problems with fatigue , dyspnoea , appetite loss and trouble with taste were reported .


Recovery occurred by 6 months ( except severe fatigue and insomnia in > 15 % of patients ) and maintained at follow-up with no differences between groups .


CRT for localised oesophageal cancer has a significant detrimental impact on many aspects of HRQL ; however , recovery is achieved by 6 months and maintained with the exception of persisting problems with severe fatigue and insomnia .


The data suggest that the HRQL recovery after definitive CRT is quicker , and there is little lasting deficit compared with treatment including surgery .


These data need to be compared with HRQL data from studies evaluating treatments including surgery for oesophageal cancer .


Ischemic heart disease is a leading worldwide cause of death .


The Seattle Post Myocardial Infarction Model ( SPIM ) was developed to predict survival 6 months to 2 years after an acute myocardial infarction with evidence of left ventricular dysfunction .


A total of 6632 subjects from the EPHESUS trial were used to derive the predictive model , while 5477 subjects from the OPTIMAAL trial were used to validate the model .


Cox proportional hazards modeling was used to develop a multivariate risk score predictive of all-cause mortality .


The SPIM risk score integrated lab and vital parameters , Killip class , reperfusion or revascularization , the number of cardiac evidence-based medicines ( aspirin , statin , blocker , ACEI/ARB , aldosterone blocker ) , and the number of cardiac risk factors .


The model was predictive of all-cause mortality after myocardial infarction , with an AUC of 0.75 at 6 months and 0.75 at 2 years in the derivation cohort and 0.77 and 0.78 for the same time points in the validation cohort .


Model predicted versus Kaplan-Meier observed survival was excellent in the derivation cohort .


It remained so in the validation cohort -- 84.9 % versus 85.0 % at 2 years .


The 10 % of subjects with the highest predicted risk had approximately 25 times higher mortality at 2 years than the 10 % of subjects with the lowest predicted risk .


The SPIM score was a powerful predictor of outcomes after myocardial infarction with left ventricular dysfunction .


Its highly accurate predictions should improve patient and physician understanding of survival and may prove a useful tool in post-infarct risk stratification .


To evaluate the effect of finasteride on serum androst-4-ene-3 ,17 - dione ( androstenedione ) and its association with prostate cancer risk among subjects who participated in the Prostate Cancer Prevention Trial .


We analyzed serum androstenedione levels in 317 prostate cancer cases and 353 controls , nested in the Prostate Cancer Prevention Trial , a randomized placebo-controlled trial that found finasteride decreased prostate cancer risk .


Androstenedione is the second most important circulating androgen in men besides testosterone and also a substrate for 5-reductase enzyme .


We observed a 22 % increase in androstenedione levels compared with the baseline values in subjects who were treated with finasteride for 3 years .


This significant increase did not vary by case-control status .


Adjusted odds ratio and 95 % confidence interval for the third tertile of absolute change in androstenedione levels compared with the first tertile were 0.42 ( 95 % confidence interval , 0.19-0 .94 ) for low-grade ( Gleason score < 7 ) cases .


Similar results were observed when analyzed using percent change .


There were no significant associations between serum androstenedione levels and the risk of high-grade disease .


The results of this nested case-control study confirm that finasteride blocks the conversion of testosterone to dihydrotestosterone ( DHT ) and of androstenedione to 5-androstanedione-3 ,17 - dione , which also leads to the reduction of DHT formation .


This decrease in DHT may help reduce the risk of low-grade prostate cancer in men .


Our data on a differential effect of androstenedione also suggest that some high-grade prostate cancers may not require androgen for progression .


Vasopressin and corticosteroids are both commonly used adjunctive therapies in septic shock .


Retrospective analyses have suggested that there may be an interaction between these drugs , with higher circulating vasopressin levels and improved outcomes in patients treated with both vasopressin and corticosteroids .


We aimed to test for an interaction between vasopressin and corticosteroids in septic shock .


Prospective open-label randomized controlled pilot trial .


Four adult ICUs in London teaching hospitals .


Sixty-one adult patients who had septic shock .


Initial vasopressin IV infusion titrated up to 0.06 U/min and then IV hydrocortisone ( 50 mg 6 hourly ) or placebo .


Plasma vasopressin levels were measured at 6-12 and 24-36 hours after hydrocortisone/placebo administration .


Thirty-one patients were allocated to vasopressin + hydrocortisone and 30 patients to vasopressin + placebo .


The hydrocortisone group required a shorter duration of vasopressin therapy ( 3.1 d ; 95 % CI , 1.1-5 .1 ; shorter in hydrocortisone group ) and required a lower total dose of vasopressin ( ratio , 0.47 ; 95 % CI , 0.32-0 .71 ) compared with the placebo group .


Plasma vasopressin levels were not higher in the hydrocortisone group compared with the placebo group ( 64 pmol/L difference at 6 - to 12-hour time point ; 95 % CI , -32 to 160 pmol/L ) .


Early vasopressin use was well tolerated with only one serious adverse event possibly related to study drug administration reported .


There were no differences in mortality rates ( 23 % 28-day mortality in both groups ) or organ failure assessments between the two treatment groups .


Hydrocortisone spared vasopressin requirements , reduced duration , and reduced dose , when used together in the treatment of septic shock , but it did not alter plasma vasopressin levels .


Further trials are needed to assess the clinical effectiveness of vasopressin as the initial vasopressor therapy with or without corticosteroids .


Current holistic rehabilitation blends both physical and psychological techniques .


However , validation of the usefulness of psychological strategies is limited in the literature .


To quantify the effects of psychological strategies on both physiologic ( salivary cortisol ) and subjective assessments of stress .


Randomized controlled clinical trial .


Laboratory .


A total of 97 college-aged students ( age = 20.65 4.38 years ) , most with little to no experience with psychological strategies .


A 15-minute script via an iPod led the participant through visual imagery ( cognitive relaxation ) or deep breathing exercises ( somatic relaxation ) cues .


The control group listened to 15 minutes of ambient nature sounds .


Two samples ( pretest , posttest ) of salivary cortisol were analyzed using an enzyme immunoassay kit ; the average was used for statistical analysis .


Descriptive statistics and correlations were conducted to examine group differences in time of day , salivary cortisol , sex , Stress-O-Meter values , and Perceived Stress Scale scores .


Salivary cortisol levels were lower in the treatment group than the control group ( F2 ,97 = 15.62 , P < .001 ) .


Females had higher scores on both the pretest Stress-O-Meter ( 5.15 1.796 ) and the Perceived Stress Scale ( 18.31 5.833 ) than males ( 4.25 1.741 and 15.272 5.390 , respectively ) .


Both cognitive and somatic relaxation strategies reduced cortisol levels .


Participants who received verbal guidance achieved a larger cortisol reduction .


However , the change in cortisol level was uncorrelated with the change in report of acute stress ; females reported higher levels of stress .


Clinical implications include attention to sex when assessing stress and providing coping skills during the rehabilitation process .


To explore the efficiency of single application of lobaplatin in tran-scatheter arterial chemoembolization ( TACE ) for patients with a primary hepatic carcinoma who were unable or unwilling to undergo surgery .


173 patients with primary hepatic carcinoma diagnosed by imaging or pathology were randomly divided into experimental and control groups and respectively treated with lobaplatin and pirarubicin hydrochloride as chemotherapeutic drugs for TACE .


The amount of iodipin was regulated according to the tumor number and size , and then gelatin sponge or polyvinyl alcohol particles were applied for embolisms .


The efficiency of treatment in the two groups was compared with reference to survival time and therapeutic response .


The experimental group ( single lobaplatin as chemotherapy drug ) was superior to control group ( single pirarubicin hydrochloride as chemotherapy drug ) in the aspects of survival time and therapeutic response , with statistical significance .


Single lobaplatin can be as a chemotherapy drug in TACE and has better efficiency in the aspects of mean survival time and therapeutic response , deserving to be popularized in the clinic .


The primary objective of this study was to compare Aquacel ( ConvaTec , Skillman , New Jersey ) , Allevyn ( Smith & Nephew , St Petersburg , Florida ) , and Mediskin I ( Mlnlycke , Health Care AB , Gothenburg , Sweden ) in the treatment of split-thickness skin graft donor sites .


This study was performed as a prospective randomized , 3-arm , clinical study .


A clinical study performed at a hand and plastic surgery department with burn unit .


The study included 67 adults with a total of 73 donor sites , which were on the thigh , not reharvested , and ranged between 30 - and 400-cm area .


Subjects were randomly assigned to treatment with Aquacel , Allevyn , or Mediskin I.


The donor site was assessed on postoperative days 3 , 14 , and 21 for healing , infection , pain , impact on everyday life , ease of use , and cost .


The obtained results demonstrate significantly faster re-epithelialization for patients treated with Aquacel or Mediskin I compared with Allevyn .


Regarding infections , there were no significant differences between the groups .


Patients wearing Aquacel experienced significantly less pain changing the dressing and less impact on everyday life than the patients wearing Allevyn .


Aquacel was shown to be significantly easier for the caregiver to use than Allevyn and Mediskin I.


There is a significant difference in cost of treatment between the dressings , whereas Mediskin I is the most expensive .


The authors ' results support the use of Aquacel in the treatment of split-thickness skin graft donor sites .


Aquacel has a low cost per unit , is user friendly , gives short healing time , and minimizes patient discomfort .


There is a higher prevalence of obesity in individuals with mental disorders compared to the general population .


The results of several studies suggested that weight reduction in this population is possible following psycho-educational and/or behavioural weight management interventions .


Evidence of the effectiveness alone is however inadequate for policy making .


The aim of the current study was to evaluate the cost-effectiveness of a health promotion intervention targeting physical activity and healthy eating in individuals with mental disorders .


A Markov decision-analytic model using a public payer perspective was applied , projecting the one-year results of a 10-week intervention over a time horizon of 20 years , assuming a repeated yearly implementation of the programme .


Scenario analysis was applied evaluating the effects on the results of alternative modelling assumptions .


One-way sensitivity analysis was performed to assess the effects on the results of varying key input parameters .


An incremental cost-effectiveness ratio of 27,096 / quality-adjusted life years ( QALY ) in men , and 40,139 / QALY in women was found in the base case .


Scenario analysis assuming an increase in health-related quality of life as a result of the body mass index decrease resulted in much better cost-effectiveness in both men ( 3,357 / QALY ) and women ( 3,766 / QALY ) .


The uncertainty associated with the intervention effect had the greatest impact on the model .


As far as is known to the authors , this is the first health economic evaluation of a health promotion intervention targeting physical activity and healthy eating in individuals with mental disorders .


Such research is important as it provides payers and governments with better insights how to spend the available resources in the most efficient way .


Further research examining the cost-effectiveness of health promotion targeting physical activity and healthy eating in individuals with mental disorders is required .


The aim of this study was to investigate the effects of shock wave therapy on gait pattern in children with hemiplegic cerebral palsy .


Fifteen children were assigned to the study group , whose members received shock wave therapy ( 1500 shots/muscle , frequency of 5Hz , energy of 0.030 mJ/mm , one session/wk ) .


Another 15 were assigned to the control group , whose members participated in a conventional physical therapy exercise program for 3 successive months .


Baseline and posttreatment assessments were performed using the Modified Ashworth Scale to evaluate spasticity degrees and using a three-dimensional gait analysis to evaluate gait parameters .


Children in the study group showed a significant improvement when compared with those in the control group ( P < 0.005 ) .


The Modified Ashworth scores after treatment were 1.86 ( 0.22 ) and 1.63 ( 0.23 ) for the control and study groups , respectively .


The gait parameters ( stride length , cadence , speed , cycle time , and stance phase percentage ) after treatment were 0.5 m , 125 steps/min , 0.6 m/sec , 0.48 sec , and 50.4 % and 0.74 m , 119 steps/min , 0.75 m/sec , 0.65 sec , and 55.9 % for the control group and the study group , respectively .


Shock wave therapy may be a useful tool for improving spasticity and gait pattern in children with hemiplegic cerebral palsy .


To develop and validate composite disease activity scores , based on widely available clinical measures , that would demonstrate improved correlation with detection of synovitis on magnetic resonance imaging ( MRI ) and radiographic progression , in comparison with conventional measures , in patients with rheumatoid arthritis ( RA ) .


This study was conducted as a secondary study of 2 RA clinical trials , GO-BEFORE ( development cohort ) and GO-FORWARD ( validation cohort ) .


Generalized estimating equations were used to evaluate independent cross-sectional associations of component variables ( from all time points ) with concurrent MRI measures of synovitis and bone edema in the development cohort .


Based on regression coefficients , modified versions of the Disease Activity Score in 28 joints ( M-DAS28 ) , Simplified Disease Activity Index ( M-SDAI ) , and Clinical Disease Activity Index ( M-CDAI ) were generated for each subject in the validation cohort .


The M-DAS28 , M-SDAI , and M-CDAI scores were compared to conventional scores of disease activity with regard to associations with MRI measures of synovitis and radiographic progression , assessed using Pearson 's and Spearman 's correlations , linear/logistic regression , and receiver operating characteristic analysis .


Four variables were independently associated with MRI-detected synovitis and bone edema in the development cohort : C-reactive protein ( CRP ) level , erythrocyte sedimentation rate ( ESR ) , swollen joint count in 28 joints ( SJC28 ) , and evaluator 's global assessment of disease activity using a visual analog scale ( EvGA score ) .


Modified disease activity scores were generated using the regression coefficients obtained in the synovitis models for all subjects in the validation cohort ; modified scores were calculated as M-DAS28 = 0.49 ln ( CRP ) + 0.15 SJC28 + 0.22 EvGA + 1 and M-SDAI = CRP + SJC28 + EvGA .


Both modified and conventional disease activity scores correlated significantly with MRI measures of synovitis .


Modified scores showed superior correlation with synovitis , as compared to conventional scores , at all time points ( P < 0.05 ) .


Furthermore , the M-DAS28 and M-SDAI had superior test characteristics for prediction of radiographic progression at 52 weeks ( both P < 0.05 ) .


Modified disease activity scores demonstrated superior correlation with MRI detection of synovitis at all time points , and more accurately predicted radiographic progression in patients with RA in a clinical trial setting .


To observe the efficacy in cervical headache of acupuncture combined with fire needling and the simple acupuncture therapy .


One hundred and eighty cases were randomized into an acupuncture plus fire needling group ( group A ) and an acupuncture group ( group B ) , 90 cases in each one .


Baihui ( GV 20 ) , Wangu ( GB 12 ) , Fengchi ( GB 20 ) , Tianzhu ( BL 10 ) and Neck-Jiaji ( EX-B 2 ) were selected in the two groups .


In group A , the fire needling technique was applied to all the above points before acupuncture with filiform needles .


In group B , the acupuncture therapy was used only .


The treatment was given once a day , the efficacy was compared between the two groups after 20 treatments .


The total effective rate was 95.6 % ( 86/90 ) in group A and was 84.4 % ( 76/90 ) in group B , indicating the significant difference in comparison ( P < 0.05 ) .


VAS were 7.44 + / -1.26 and 0.73 + / - l. 44 before and after treatment in group A separately , those were 7.56 + / -1.07 and 2.56 + / -2.99 in group B , indicating the significant difference in comparison ( P < 0.01 ) .


The difference in VAS after treatment was significant between the two groups .


In group A , the follow-up visit was conducted at 3 months and 6 months after treatment for the cured cases .


The total recurrence rate in the patients without bony pathological changes was 14.8 % ( 4/27 ) and that in the patients with bony pathological changes was 43.5 % ( 10/23 ) , there was significant difference between them ( P < 0.05 ) .


The combined therapy of fire needling technique and filiform needle acupuncture improves the efficacy and sustains the efficacy especially on cervical headache without bony pathological changing .


Liver-selective thyromimetic agents could provide a new approach for treating dyslipidaemia .


We performed a multicentre , randomized , placebo-controlled , double-blind study to evaluate the efficacy and safety of eprotirome , a liver-selective thyroid hormone receptor agonist , in 98 patients with primary hypercholesterolaemia .


After previous drug wash-out and dietary run-in , patients received 100 or 200 g day ( -1 ) eprotirome or placebo for 12 weeks .


The primary end-point was change in serum LDL cholesterol ; secondary end-points included changes in other lipid parameters and safety measures .


Eprotirome treatment at 100 and 200 g daily reduced serum LDL cholesterol levels by 23 5 % and 31 4 % , respectively , compared with 2 6 % for placebo ( P < 0.0001 ) .


Similar reductions were seen in non-HDL cholesterol and apolipoprotein ( apo ) B , whereas serum levels of HDL cholesterol and apo A-I were unchanged .


There were also considerable reductions in serum triglycerides and lipoprotein ( a ) , in particular in patients with elevated levels at baseline .


There was no evidence of adverse effects on heart or bone and no changes in serum thyrotropin or triiodothyronine , although the thyroxine level decreased .


Low-grade increases in liver enzymes were evident in most patients .


In hypercholesterolaemic patients , the liver-selective thyromimetic eprotirome decreased serum levels of atherogenic lipoproteins without signs of extra-hepatic side effects .


Selective stimulation of hepatic thyroid hormone receptors may be an attractive way to modulate lipid metabolism in hyperlipidaemia .


Impulsive decision making is a hallmark of frequently occurring addiction disorders including alcohol dependence ( AD ) .


Therefore , ameliorating impulsive decision making is a promising target for the treatment of AD .


Previous studies have shown that modafinil enhances cognitive control functions in various psychiatric disorders .


However , the effects of modafinil on delay discounting and its underlying neural correlates have not been investigated as yet .


The aim of the current study was to investigate the effects of modafinil on neural correlates of impulsive decision making in abstinent AD patients and healthy control ( HC ) subjects .


A randomized , double-blind , placebo-controlled , within-subjects cross-over study using functional magnetic resonance imaging ( fMRI ) was conducted in 14 AD patients and 16 HC subjects .


All subjects participated in two fMRI sessions in which they either received a single dose of placebo or 200mg of modafinil 2h before the session .


During fMRI , subjects completed a delay-discounting task to measure impulsive decision making .


Modafinil improved impulsive decision making in AD pateints , which was accompanied by enhanced recruitment of frontoparietal regions and reduced activation of the ventromedial prefrontal cortex .


Moreover , modafinil-induced enhancement of functional connectivity between the superior frontal gyrus and ventral striatum was specifically associated with improvement in impulsive decision making .


These findings indicate that modafinil can improve impulsive decision making in AD patients through an enhanced coupling of prefrontal control regions and brain regions coding the subjective value of rewards .


Therefore , the current study supports the implementation of modafinil in future clinical trials for AD .


Although many attention-deficit/hyperactivity disorder ( ADHD ) care models have been studied , few have demonstrated individual-level symptom improvement .


We sought to test whether complementing basic collaborative care with interventions that address common reasons for symptom persistence improves outcomes for children with inattention and hyperactivity/impulsivity .


We conducted a randomized comparative effectiveness trial of 2 care management systems for 6 - to 12-year-old children being evaluated for ADHD ( n = 156 ) .


All participants received care management with decision support .


Care managers in the enhanced care arm also were trained in motivational and parent management techniques to help parents engage in their child 's treatment , address their own mental health needs , and manage challenging child behaviors .


We used multivariable models to assess inattention , hyperactivity/impulsivity , oppositionality , and social skills over 1 year .


Both treatment arms generated guideline concordant diagnostic processes in 94 % of cases ; 40 % of children had presentations consistent with ADHD .


For the entire sample , there were no differences in symptom trajectories between study arms ; mean differences in change scores at 12 months were -0.14 ( 95 % confidence interval -0.34 to 0.07 ) for inattention ; -0.13 ( -0.31 to 0.05 ) for hyperactivity/impulsivity ; -0.09 ( -0.28 to 0.11 ) for oppositionality ; and 3.30 ( -1.23 to 7.82 ) for social skills .


Among children with ADHD-consistent presentations , enhanced arm participants experienced superior change scores for hyperactivity/impulsivity of -0.36 ( -0.69 to -0.03 ) , oppositionality -0.40 ( -0.75 to -0.05 ) , and social skills 9.57 ( 1.85 to 17.28 ) .


Among children with ADHD-consistent presentations , addressing barriers to engagement with care and challenging child behaviors has potential to improve the effectiveness of collaborative care .


Fish oil supplementation has been shown to alter gene expression of mononuclear cells both in vitro and in vivo .


However , little is known about the total transcriptome profile in healthy subjects after intake of fish oil .


We therefore investigated the gene expression profile in peripheral blood mononuclear cells ( PBMCs ) after intake of fish oil for 7 weeks using transcriptome analyses .


In a 7-week , double-blinded , randomized , controlled , parallel-group study , healthy subjects received 8 g day ( -1 ) fish oil ( 1.6 g day ( -1 ) eicosapentaenoic acid + docosahexaenoic acid ) ( n = 17 ) or 8 g day ( -1 ) high oleic sunflower oil ( n = 19 ) .


Microarray analyses of RNA isolated from PBMCs were performed at baseline and after 7 weeks of intervention .


Cell cycle , DNA packaging and chromosome organization are biological processes found to be upregulated after intake of fish oil compared to high oleic sunflower oil using a moderated t-test .


In addition , gene set enrichment analysis identified several enriched gene sets after intake of fish oil .


The genes contributing to the significantly different gene sets in the subjects given fish oil compared with the control group are involved in cell cycle , endoplasmic reticulum ( ER ) stress and apoptosis .


Gene transcripts with common motifs for 35 known transcription factors including E2F , TP53 and ATF4 were upregulated after intake of fish oil .


We have shown that intake of fish oil for 7 weeks modulates gene expression in PBMCs of healthy subjects .


The increased expression of genes related to cell cycle , ER stress and apoptosis suggests that intake of fish oil may modulate basic cellular processes involved in normal cellular function .


Despite increasing trends toward the early initiation of oral feeding after gastrointestinal ( GI ) surgeries , current evidence has not been convincing .


The present randomized clinical trial aimed to compare the clinical outcomes of early oral feeding ( EOF ) with late oral feeding ( LOF ) following surgery for upper GI tumors .


One hundred and nine consecutive patients with esophageal or gastric tumors undergoing surgical resection in two hospitals in Tehran , Iran , were enrolled in this prospective randomized controlled trial , and were randomly assigned to a group starting EOF on the first postoperative day and another group that remained nil by mouth until the return of bowel sounds ( LOF group ) .


The clinical and surgical outcomes were compared between the two groups .


The clinical outcomes were significantly better in the patients in the EOF group ( p < 0.05 ) .


Repeated nil per os ( 14.8 vs. 30.9 % ) and re-hospitalization ( 1.8 vs. 7.3 % ) were more common in LOF group ( p < 0.0001 ) .


Additionally , gas passage , nasogastric tube ( NGT ) discharge , a decrease in intravenous serum to less than 1000 ml per day , the time to start a soft diet and hospital discharge following surgery occurred significantly earlier in the EOF group than in the LOF group ( p < 0.0001 ) .


Early oral feeding after the surgical resection of esophageal and gastric tumors is safe , and is associated with favorable early in-hospital outcomes and a sooner return to physiological GI function and hospital discharge .


To examine whether socioeconomic position ( SEP ) was associated with change in cardiovascular risk factors and meeting treatment targets for cardiovascular risk factors among individuals with screen-detected Type 2 DM at six-year follow-up .


The study population was 1533 people with Type 2 DM identified from at stepwise diabetes screening programme in general practice during 2001-2006 in the ADDITION-Denmark study .


The ADDITION-study was performed as a randomised trial but the two randomisation groups were analysed as one cohort in this study .


Cardiovascular risk factors were measured at baseline and repeated at follow-up ( mean : 5.9 [ 1.4 ] years ) .


Information on SEP , redeemed antihypertensive and lipid-lowering treatment were obtained from Danish registers .


Multivariate analyses were performed to estimate change in cardiovascular risk factors and difference in meeting treatment targets .


The change in HbA1c , cholesterol , blood pressure and BMI were virtually the same across educational level , income level , occupational status or cohabiting status .


Overall , the ability to meet treatment targets for HbA1c , cholesterol and blood pressure was not modified by SEP-group .


A higher proportion of people with lower educational level or lower income level in the intensive care redeemed anti-hypertensive treatment compared to people with higher educational or income levels .


Screen-detection and early treatment onset did not introduce socioeconomic inequality in metabolic control in people with screen-detected Type 2 DM at six-year follow-up .


To assess the efficacy of a financial incentive added to routine specialist pregnancy stop smoking services versus routine care to help pregnant smokers quit .


Phase II therapeutic exploratory single centre , individually randomised controlled parallel group superiority trial .


One large health board area with a materially deprived , inner city population in the west of Scotland , United Kingdom .


612 self reported pregnant smokers in NHS Greater Glasgow and Clyde who were English speaking , at least 16 years of age , less than 24 weeks pregnant , and had an exhaled carbon monoxide breath test result of 7 ppm or more .


306 women were randomised to incentives and 306 to control .


The control group received routine care , which was the offer of a face to face appointment to discuss smoking and cessation and , for those who attended and set a quit date , the offer of free nicotine replacement therapy for 10 weeks provided by pharmacy services , and four , weekly support phone calls .


The intervention group received routine care plus the offer of up to 400 of shopping vouchers : 50 for attending a face to face appointment and setting a quit date ; then another 50 if at four weeks ' post-quit date exhaled carbon monoxide confirmed quitting ; a further 100 was provided for continued validated abstinence of exhaled carbon monoxide after 12 weeks ; a final 200 voucher was provided for validated abstinence of exhaled carbon monoxide at 34-38 weeks ' gestation .


The primary outcome was cotinine verified cessation at 34-38 weeks ' gestation through saliva ( < 14.2 ng/mL ) or urine ( < 44.7 ng/mL ) .


Secondary outcomes included birth weight , engagement , and self reported quit at four weeks .


Recruitment was extended from 12 to 15 months to achieve the target sample size .


Follow-up continued until September 2013 .


Of the 306 women randomised , three controls opted out soon after enrolment ; these women did not want their data to be used , leaving 306 intervention and 303 control group participants in the intention to treat analysis .


No harms of financial incentives were documented .


Significantly more smokers in the incentives group than control group stopped smoking : 69 ( 22.5 % ) versus 26 ( 8.6 % ) .


The relative risk of not smoking at the end of pregnancy was 2.63 ( 95 % confidence interval 1.73 to 4.01 ) P < 0.001 .


The absolute risk difference was 14.0 % ( 95 % confidence interval 8.2 % to 19.7 % ) .


The number needed to treat ( where financial incentives need to be offered to achieve one extra quitter in late pregnancy ) was 7.2 ( 95 % confidence interval 5.1 to 12.2 ) .


The mean birth weight was 3140 g ( SD 600 g ) in the incentives group and 3120 ( SD 590 ) g in the control group ( P = 0.67 ) .


This phase II randomised controlled trial provides substantial evidence for the efficacy of incentives for smoking cessation in pregnancy ; as this was only a single centre trial , incentives should now be tested in different types of pregnancy cessation services and in different parts of the United Kingdom .


Current Controlled Trials ISRCTN87508788 .


To compare the efficacy and safety of the intraocular lens ( IOL ) - shell procedure versus conventional phacoemulsification for the surgical treatment of dense cataracts .


Eighty eyes with dense nuclear cataracts were enrolled in a prospective , randomized controlled study .


Patients were assigned to two groups .


In Group I , the IOL was traditionally implanted after all nuclear fragments were completely removed , and in Group II , the IOL was innovatively implanted in the bag before the last residual nuclear fragment was removed .


This novel adjusted surgical procedure , named the `` IOL-shell technique '' , features use of the IOL as a protective barrier rather than simply as a refractive alternative , and it is conceptually different from the traditional step-by-step procedure .


Clinical examinations , including uncorrected visual acuity , central corneal thickness ( CCT ) , temporal clear corneal incision thickness and corneal endothelial cell density , were carried out .


The inter-group difference in temporal corneal thickness was found to be of no statistical significance at any of the visits .


Compared to eyes in Group I , those in Group II were shown to have significantly less corneal endothelial cell loss on both the 7th and 30th day following surgery .


At 7 days after surgery , the mean corneal endothelial cell loss in Group II was 10.29 % , compared to 14.37 % in Group I ( P < 0.05 ) .


The mean endothelial cell loss measured on postoperative day 30 was 16.88 % in Group II compared to 23.32 % in Group I ( P < 0.05 ) .


On the 1st day after surgery , the mean CCT of eyes in Group II was significantly smaller compared to Group I ( Group I vs. Group II : 19.42 % vs. 13.50 % , P < 0.05 ) .


Compared to conventional phacoemulsification , the IOL-shell technique was shown to be a relatively safer procedure without compromised efficiency for dense cataracts , and it caused less corneal endothelial cell loss and milder postoperative corneal edema ( Clinical Trials Identifier : NCT02138123 ) .


ClinicalTrials.gov NCT02138123 .


Early prognostication after successful cardiopulmonary resuscitation is difficult , and there is a need for novel methods to estimate the extent of brain injury and predict outcome .


In this study , we evaluated the impact of the cardiac arrest syndrome on the plasma levels of selected tissue-specific microRNAs ( miRNAs ) and assessed their ability to prognosticate death and neurological disability .


We included 65 patients treated with hypothermia after cardiac arrest in the study .


Blood samples were obtained at 24 hours and at 48 hours .


For miRNA-screening purposes , custom quantitative polymerase chain reaction ( qPCR ) panels were first used .


Thereafter individual miRNAs were assessed at 48 hours with qPCR .


miRNAs that successfully predicted prognosis at 48 hours were further analysed at 24 hours .


Outcomes were measured according to the Cerebral Performance Category ( CPC ) score at 6 months after cardiac arrest and stratified into good ( CPC score 1 or 2 ) or poor ( CPC scores 3 to 5 ) .


At 48 hours , miR-146a , miR-122 , miR-208b , miR-21 , miR-9 and miR-128 did not differ between the good and poor neurological outcome groups .


In contrast , miR-124 was significantly elevated in patients with poor outcomes compared with those with favourable outcomes ( P < 0.0001 ) at 24 hours and 48 hours after cardiac arrest .


Analysis of receiver operating characteristic curves at 24 and 48 hours after cardiac arrest showed areas under the curve of 0.87 ( 95 % confidence interval ( CI ) = 0.79 to 0.96 ) and 0.89 ( 95 % CI = 0.80 to 0.97 ) , respectively .


The brain-enriched miRNA miR-124 is a promising novel biomarker for prediction of neurological prognosis following cardiac arrest .


We compare attribution and social comparison theories as potential explanations for attitudes towards overweight and underweight targets among Australian university students .


185 female students ( median age 18 ) completed a measure of body image state , then read one of six vignettes , describing a female student who was underweight , average weight or overweight , and who did or did not have a medical condition affecting weight .


Independent variables were target weight ( underweight , average-weight , overweight ) ; weight controllability ( no information , uncontrollable ) ; and participant body image ( higher , lower ) .


Participants evaluated the target on six characteristics derived from existing research on weight bias , on seven-point Likert scales : attractive ; healthy ; likeable ; motivated ; self-disciplined ; having willpower .


A three-way between-participants multivariate analysis of covariance was conducted , with post hoc comparisons of significant effects .


Overweight targets were rated more negatively than average-weight and underweight targets .


Uncontrollability ( medical ) information produced more positive evaluations of the overweight target , but more negative evaluations of the underweight target .


Ratings of the average-weight target were not influenced by uncontrollability information .


Participant body image state had no significant effects .


Results provided partial support for attribution theory , but not for social comparison theory , as an explanation of weight bias .


Severe anaemia in children is a leading cause of hospital admission and a major cause of mortality in sub-Saharan Africa , yet there are limited published data on blood transfusion in this vulnerable group .


We present data from a large controlled trial of fluid resuscitation ( Fluid Expansion As Supportive Therapy ( FEAST ) trial ) on the prevalence , clinical features , and transfusion management of anaemia in children presenting to hospitals in three East African countries with serious febrile illness ( predominantly malaria and/or sepsis ) and impaired peripheral perfusion .


Of 3,170 children in the FEAST trial , 3,082 ( 97 % ) had baseline haemoglobin ( Hb ) measurement , 2,346 / 3,082 ( 76 % ) were anaemic ( Hb < 10 g/dL ) , and 33 % severely anaemic ( Hb < 5 g/dL ) .


Prevalence of severe anaemia varied from 12 % in Kenya to 41 % in eastern Uganda .


1,387 / 3,082 ( 45 % ) children were transfused ( 81 % within 8 hours ) .


Adherence to WHO transfusion guidelines was poor .


Among severely anaemic children who were not transfused , 52 % ( 54/103 ) died within 8 hours , and 90 % of these deaths occurred within 2.5 hours of randomisation .


By 24 hours , 128/1 ,002 ( 13 % ) severely anaemic children had died , compared to 36/501 ( 7 % ) and 71/843 ( 8 % ) of those with moderate and mild anaemia , respectively .


Among children without severe hypotension who were randomised to receive fluid boluses of 0.9 % saline or albumin , mortality was increased ( 10.6 % and 10.5 % , respectively ) compared to controls ( 7.2 % ) , regardless of admission Hb level .


Repeat transfusion varied from 2 % in Kenya/Tanzania to 6 to 13 % at the four Ugandan centres .


Adverse reactions to blood were rare ( 0.4 % ) .


Severe anaemia complicates one third of childhood admissions with serious febrile illness to hospitals in East Africa , and is associated with increased mortality .


A high proportion of deaths occurred within 2.5 hours of admission , emphasizing the need for rapid recognition and prompt blood transfusion .


Adherence to current WHO transfusion guidelines was poor .


The high rates of re-transfusion suggest that 20 mL/kg whole blood or 10 mL/kg packed cells may undertreat a significant proportion of anaemic children .


Future evaluation of the impact of a larger volume of transfused blood and optimum transfusion management of children with Hb of < 6 g/dL is warranted .


To assess long-term superiority in terms of chronic pain between prolene hernia system ( PHS ) , mesh plug repair ( MPR ) and Lichtenstein ( L ) technique for inguinal hernia repair .


Eight years after randomizing three commonly used techniques for primary inguinal hernia repair , the outcome was evaluated with a questionnaire measuring pain on verbal descriptor and visual analogue scales , including limitations on daily life activities , sensory disturbances and recurrences .


From previous results patients characteristics , operative details and short - and mid-term pain outcome were extracted .


270 out of 308 eligible patients ( 88 % ) completed the follow-up after median 7.6 years ( range 6.9-9 .2 ) after the inguinal hernia operation .


No significant differences between the repair techniques were found for pain , sensory disturbances or recurrences .


Overall , the hernia recurrence rate was 6.3 % .


In total 63 patients ( 23 % ) reported long-term pain of which one-fourth graded this moderate to severe .


Pain was experienced at least weekly by 26 patients ( 10 % ) and limiting daily activities for 36 patients ( 13 % ) .


With regard to the previously reported pain at 3 and 15 months follow-up , 106 patients ( 39 % ) experience no pain at all .


For 101 patients ( 37 % ) , initial pain disappeared .


41 patients ( 15 % ) suffered persisting pain at all three measure moments .


22 patients ( 8 % ) reported pain at 8 years follow-up after an initial pain-free period .


Long-term outcome after randomizing PHS , MPR and L showed no clinically relevant differences in chronic pain and its consequences .


Although chronic pain is diminishing over time it remains a serious complication and has sometimes an onset long after the inguinal repair .


Previous work has demonstrated paradoxical increases in cerebral oxygen saturation ( ScO2 ) as blood pressure decreases and paradoxical decreases in ScO2 as blood pressure increases .


It has been suggested that these paradoxical responses indicate a functional cerebral autoregulation mechanism .


Accordingly , the authors hypothesized that if this suggestion is correct , paradoxical responses will occur exclusively in patients with intact cerebral autoregulation .


Thirty-four patients undergoing elective cardiac surgery were included .


Cerebral autoregulation was assessed with the near-infrared spectroscopy-derived cerebral oximetry index ( COx ) , computed by calculating the Spearman correlation coefficient between mean arterial pressure and ScO2 .


COx less than 0.30 was previously defined as functional autoregulation .


During cardiopulmonary bypass , 20 % change in blood pressure was accomplished with the use of nitroprusside for decreasing pressure and phenylephrine for increasing pressure .


Effects on COx were assessed .


Data were analyzed using two-way ANOVA , Kruskal-Wallis test , and Wilcoxon and Mann-Whitney U test .


Sixty-five percent of patients had a baseline COx less than 0.30 , indicating functional baseline autoregulation .


In 50 % of these patients ( n = 10 ) , COx became highly negative after vasoactive drug administration ( from -0.04 [ -0.25 to 0.16 ] to -0.63 [ -0.83 to -0.26 ] after administration of phenylephrine , and from -0.05 [ -0.19 to 0.17 ] to -0.55 [ -0.94 to -0.35 ] after administration of nitroprusside ) .


A negative COx implies a decrease in ScO2 with increase in pressure and , conversely , an increase in ScO2 with decrease in pressure .


In this study , paradoxical changes in ScO2 after pharmacological-induced pressure changes occurred exclusively in patients with intact cerebral autoregulation , corroborating the hypothesis that these paradoxical responses might be attributable to a functional cerebral autoregulation .


In many facilities , drains are routinely inserted after thyroidectomy with the aim of preventing hematoma formation and accumulation of seroma .


The continued use of drains may be based more on tradition rather than proven scientific evidence .


To assess the benefit of drain use after thyroidectomy by determining ; length of hospital stay , post operative pain and wound sepsis .


This was a randomized controlled trial , carried out at a tertiary national referral hospital ( Mulago , Kampala ) .


Over a 6 month period in 2011 , we recruited 68 patients .


Socio-demographic information and clinical parameters were recorded .


Outcomes measures were evaluated .


Data were double entered into epidata version 3.1.1 and analyzed using STATA version 10.0 .


Ethical approval was secured .


Mean age of participants was 46 and 43.7 years in drain and no drain arm respectively .


Most participants were female .


Mean duration of hospital stay after thyroidectomy was significantly higher among the drain arm as compared with the no drain arm [ 2.41 ( 0.89 ) vs 1.71 ( 0.76 ) days ( p = 0.0008 ) ] .


One patient ( drain arm ) had wound infection .


The pain score on the postoperative day was statistically higher among in the drain arm than the no drain arm [ 5.71 vs 2.53 ( p = 0.001 ) ] .


Not inserting a drain post operatively after thyroid surgery was associated with short hospital stay and less operative pain .


Results of this study do not support routine drainage after thyroid surgery .


Despite precise surgical technique , some postoperative facial scars will depress and widen over time , likely due to weakened or inadequately replaced collagen fibers in the underlying dermis .


The purpose of this study is to evaluate whether a 10,600 nm ablative carbon dioxide ( CO2 ) fractional laser used early in the post-surgical setting results in improved postoperative facial scars after a single treatment session .


A prospective randomized , comparative split-scar study was conducted on 20 subjects between the ages of 20-90 .


Subjects underwent Mohs surgery for nonmelanoma skin cancer of the face .


Subsequent to tumor removal , subjects with a linear scar of 4 cm or greater were enrolled .


On the day of suture removal , all subjects had one-half of their scar randomly selected and treated with a 10,600 nm CO2 fractional laser ( energy = 10 mJ ; density = 10 % ; spot size = 7 mm ; pulse = 1 ) .


The untreated scar half served as a control .


Scars were re-evaluated 12 weeks later .


An independent blinded observer graded the scar halves with the Vancouver scar scale ( VSS ) immediately prior to treatment and 12 weeks after treatment .


Subjects completed a visual analog scale ( VAS ) at the same time points .


Three months after laser treatment , a significant decrease in VSS and 3 of the 4 of its individual parameters were detected in both control and treated halves of the scar .


When comparing the laser group versus the control group , a statistically significant difference was not noted in VSS ( P = 0.31 ) but a statistically significant difference in patient VAS was detected ( P = 0.002 ) .


No side effects of the laser treatment were noted .


Facial wounds sutured in a layered manner heal well .


Patients prefer early fractional CO2 lasing of surgical scars , though use of the VSS failed to detect an objective difference between laser and control halves of scars .


Conservative laser settings , a single session treatment , and VSS insensitivity for surgical scars may influence these findings .


Web-based learning is becoming an increasingly important instructional tool in nursing education .


Multimedia advancements offer the potential for creating authentic nursing activities for developing nursing competency in clinical practice .


This study aims to describe the design , development , and evaluation of an interactive multimedia Web-based simulation for developing nurses ' competencies in acute nursing care .


Authentic nursing activities were developed in a Web-based simulation using a variety of instructional strategies including animation video , multimedia instructional material , virtual patients , and online quizzes .


A randomized controlled study was conducted on 67 registered nurses who were recruited from the general ward units of an acute care tertiary hospital .


Following a baseline evaluation of all participants ' clinical performance in a simulated clinical setting , the experimental group received 3 hours of Web-based simulation and completed a survey to evaluate their perceptions of the program .


All participants were re-tested for their clinical performances using a validated tool .


The clinical performance posttest scores of the experimental group improved significantly ( P < .001 ) from the pretest scores after the Web-based simulation .


In addition , compared to the control group , the experimental group had significantly higher clinical performance posttest scores ( P < .001 ) after controlling the pretest scores .


The participants from the experimental group were satisfied with their learning experience and gave positive ratings for the quality of the Web-based simulation .


Themes emerging from the comments about the most valuable aspects of the Web-based simulation include relevance to practice , instructional strategies , and fostering problem solving .


Engaging in authentic nursing activities using interactive multimedia Web-based simulation can enhance nurses ' competencies in acute care .


Web-based simulations provide a promising educational tool in institutions where large groups of nurses need to be trained in acute nursing care and accessibility to repetitive training is essential for achieving long-term retention of clinical competency .


Although obstructive sleep apnea ( OSA ) is associated with impaired glucose tolerance and diabetes , it remains unclear whether OSA treatment with continuous positive airway pressure ( CPAP ) has metabolic benefits .


To determine the effect of 8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA .


In a randomized controlled parallel group study , 39 participants were randomly assigned to receive either 8-hour nightly CPAP ( n = 26 ) or oral placebo ( n = 13 ) .


Sleep was polysomnographically recorded in the laboratory on each night .


CPAP adherence was ensured by continuous supervision .


Participants continued their daily routine activities outside the laboratory .


Glucose metabolism was assessed at baseline and after 2 weeks of assigned treatment using both the oral and intravenous glucose tolerance tests .


The primary outcome was the overall glucose response as quantified by the area under the curve for glucose during 2-hour oral glucose tolerance testing .


Secondary outcomes included fasting and 2-hour glucose and insulin , the area under the curves for insulin and insulin secretion , norepinephrine , insulin sensitivity , acute insulin response to glucose , and 24-hour blood pressure .


The overall glucose response was reduced ( treatment difference : -1,276.9 [ mg/dl ] min [ 95 % confidence interval , -2,392.4 to -161.5 ] ; P = 0.03 ) and insulin sensitivity was improved ( treatment difference : 0.77 [ mU/L ] ( -1 ) min ( -1 ) [ 95 % confidence interval , 0.03-1 .52 ] ; P = 0.04 ) with CPAP as compared with placebo .


Additionally , norepinephrine levels and 24-hour blood pressure were reduced with CPAP as compared with placebo .


In patients with prediabetes , 8-hour nightly CPAP treatment for 2 weeks improves glucose metabolism compared with placebo .


Thus , CPAP treatment may be beneficial for metabolic risk reduction .


Clinical trial registered with www.clinicaltrials.gov ( NCT 01156116 ) .


Atrial fibrillation ( AF ) is an important independent risk factor for stroke and oral anticoagulation therapy provides a highly effective treatment to reduce this risk .


Active screening strategies improve detection of AF in comparison with routine care ; however , whether screen-detected patients have stroke risk profiles favouring anticoagulation is unclear .


Using data derived from the screening for AF in the elderly ( SAFE ) study , the aim of this article was to determine if patients with AF detected via active screening have stroke risk profiles that warrant prophylactic anticoagulation .


Secondary analysis of data derived from 25 general practices within which cohorts of 200 patients were randomly allocated to opportunistic [ pulse and electrocardiogram ( ECG ) ] or systematic screening ( postal invitation for ECG ) .


Stroke risk assessment was undertaken using baseline data extracted from medical records and CHADS2 criteria .


CHADS2 scores were compared between the screening groups .


One hundred and forty-nine new cases of AF were detected , 75 via opportunistic screening and 74 via systematic screening .


CHADS2 scores were 1 in 83 % [ 95 % confidence interval ( CI ) 72.6-89 .6 ] of patients detected via opportunistic screening and 78 % ( 95 % CI 67.7-86 .2 ) detected via systematic screening .


There were no significant differences in stroke risk profiles of patients detected via opportunistic and systematic screenings .


Stroke risk profiles of patients detected via opportunistic and systematic screenings were similar .


Data derived from the SAFE study suggest that active screening for AF in patients aged 65 years in primary care is a useful screening programme with 78-83 % of patients identified eligible for anticoagulation treatment according to the CHADS2 criteria .


Maternal malnutrition and poor gestational weight gain are the most important causes of low birthweight and infant mortality in Bangladesh .


To assess the effect of short-term nutrition education on weight gain in the third trimester of pregnancy , birth outcomes , and breastfeeding .


Three hundred pregnant women participated in this randomized , controlled trial during a 3-month intervention period .


The study was conducted in two antenatal clinics in urban Dhaka .


One group of women was given monthly education sessions during the third trimester of pregnancy to promote consumption of khichuri , while the control group received only routine services from the health facilities .


Birthweight was recorded within 24 hours after delivery .


Breastfeeding practices were observed for 1 month after delivery .


In the intervention group , maternal weight gain in the third trimester was 60 % higher ( 8.60 vs. 5.38 kg , p = .011 ) , mean birthweight was 20 % higher ( 2.98 vs. 2.49 kg , p < .001 ) , the rate of low birthweight was 94 % lower ( 2.7 % vs. 44.7 % ; p < .001 ) , and the rate of initiation of breastfeeding within 1 hour after birth was 52 % higher ( 86.0 % vs. 56.7 % , p < .001 ) , in comparison with the control group .


Birthweight was associated with frequency of intake of khichuri ( p < 0.001 ) .


Nutrition education with a focus on promoting consumption of khichuri during the third trimester of pregnancy significantly reduced the rate of low birthweight and increased maternal weight gain .


Premenopausal women diagnosed with breast cancer are at risk for psychological and behavioral disturbances after cancer treatment .


Targeted interventions are needed to address the needs of this vulnerable group .


This randomized trial provided the first evaluation of a brief , mindfulness-based intervention for younger breast cancer survivors designed to reduce stress , depression , and inflammatory activity .


Women diagnosed with early stage breast cancer at or before age 50 who had completed cancer treatment were randomly assigned to a 6-week Mindful Awareness Practices ( MAPS ) intervention group ( n = 39 ) or to a wait-list control group ( n = 32 ) .


Participants completed questionnaires before and after the intervention to assess stress and depressive symptoms ( primary outcomes ) as well as physical symptoms , cancer-related distress , and positive outcomes .


Blood samples were collected to examine genomic and circulating markers of inflammation .


Participants also completed questionnaires at a 3-month follow-up assessment .


In linear mixed models , the MAPS intervention led to significant reductions in perceived stress ( P = .004 ) and marginal reductions in depressive symptoms ( P = .094 ) , as well as significant reductions in proinflammatory gene expression ( P = .009 ) and inflammatory signaling ( P = .001 ) at postintervention .


Improvements in secondary outcomes included reduced fatigue , sleep disturbance , and vasomotor symptoms and increased peace and meaning and positive affect ( P < .05 for all ) .


Intervention effects on psychological and behavioral measures were not maintained at the 3-month follow-up assessment , although reductions in cancer-related distress were observed at that assessment .


A brief , mindfulness-based intervention demonstrated preliminary short-term efficacy in reducing stress , behavioral symptoms , and proinflammatory signaling in younger breast cancer survivors .


In patients with metastatic breast cancer that is positive for human epidermal growth factor receptor 2 ( HER2 ) , progression-free survival was significantly improved after first-line therapy with pertuzumab , trastuzumab , and docetaxel , as compared with placebo , trastuzumab , and docetaxel .


Overall survival was significantly improved with pertuzumab in an interim analysis without the median being reached .


We report final prespecified overall survival results with a median follow-up of 50 months .


We randomly assigned patients with metastatic breast cancer who had not received previous chemotherapy or anti-HER2 therapy for their metastatic disease to receive the pertuzumab combination or the placebo combination .


The secondary end points of overall survival , investigator-assessed progression-free survival , independently assessed duration of response , and safety are reported .


Sensitivity analyses were adjusted for patients who crossed over from placebo to pertuzumab after the interim analysis .


The median overall survival was 56.5 months ( 95 % confidence interval [ CI ] , 49.3 to not reached ) in the group receiving the pertuzumab combination , as compared with 40.8 months ( 95 % CI , 35.8 to 48.3 ) in the group receiving the placebo combination ( hazard ratio favoring the pertuzumab group , 0.68 ; 95 % CI , 0.56 to 0.84 ; P < 0.001 ) , a difference of 15.7 months .


This analysis was not adjusted for crossover to the pertuzumab group and is therefore conservative .


Results of sensitivity analyses after adjustment for crossover were consistent .


Median progression-free survival as assessed by investigators improved by 6.3 months in the pertuzumab group ( hazard ratio , 0.68 ; 95 % CI , 0.58 to 0.80 ) .


Pertuzumab extended the median duration of response by 7.7 months , as independently assessed .


Most adverse events occurred during the administration of docetaxel in the two groups , with long-term cardiac safety maintained .


In patients with HER2-positive metastatic breast cancer , the addition of pertuzumab to trastuzumab and docetaxel , as compared with the addition of placebo , significantly improved the median overall survival to 56.5 months and extended the results of previous analyses showing the efficacy of this drug combination .


( Funded by F. Hoffmann-La Roche and Genentech ; CLEOPATRA ClinicalTrials.gov number , NCT00567190 . )


Sugar overconsumption and chronic stress are growing health concerns because they both may increase the risk for obesity and its related diseases .


Rodent studies suggest that sugar consumption may activate a glucocorticoid-metabolic-brain-negative feedback pathway , which may turn off the stress response and thereby reinforce habitual sugar overconsumption .


The objective of the study was to test our hypothesized glucocorticoid-metabolic-brain model in women consuming beverages sweetened with either aspartame of sucrose .


This was a parallel-arm , double-masked diet intervention study .


The study was conducted at the University of California , Davis , Clinical and Translational Science Center 's Clinical Research Center and the University of California , Davis , Medical Center Imaging Research Center .


Nineteen women ( age range 18-40 y ) with a body mass index ( range 20-34 kg/m ( 2 ) ) who were a subgroup from a National Institutes of Health-funded investigation of 188 participants assigned to eight experimental groups .


The intervention consisted of sucrose - or aspartame-sweetened beverage consumption three times per day for 2 weeks .


Salivary cortisol and regional brain responses to the Montreal Imaging Stress Task were measured .


Compared with aspartame , sucrose consumption was associated with significantly higher activity in the left hippocampus ( P = .001 ) .


Sucrose , but not aspartame , consumption associated with reduced ( P = .024 ) stress-induced cortisol .


The sucrose group also had a lower reactivity to naltrexone , significantly ( P = .041 ) lower nausea , and a trend ( P = .080 ) toward lower cortisol .


These experimental findings support a metabolic-brain-negative feedback pathway that is affected by sugar and may make some people under stress more hooked on sugar and possibly more vulnerable to obesity and its related conditions .


To compare the clinical outcomes of wavefront-guided and wavefront-optimized laser in situ keratomileusis ( LASIK ) .


Prospective , randomized , fellow-eye-controlled study .


The setting was a single academic institution .


The study population included 110 eyes of 55 patients with myopia with and without astigmatism .


One eye of each patient was randomized to undergo wavefront-guided LASIK by the AMO Visx CustomVue S4 IR excimer laser system ; the fellow eye received wavefront-optimized LASIK by the Alcon Allegretto Wave Eye-Q 400 Hz excimer laser system .


Corneal flaps were constructed using the Intralase FS 60 Hz femtosecond laser .


Patients were followed at postoperative months 1 , 3 , 6 , and 12 .


The study 's main outcome measures were uncorrected visual acuity , stability of refractive correction , contrast sensitivity , and wavefront aberrometry .


After 12 months , LASIK eyes had achieved visual acuity of 20/12 .5 or better ( 30 eyes , 56 % ) in the wavefront-guided group compared to those receiving wavefront-optimized treatment ( 22 eyes , 41 % ) ( P = 0.016 ) .


Average spherical equivalent refractions were -0.13 0.46 diopters in wavefront-guided eyes whereas in wavefront-optimized eyes the refractions were -0.41 0.38 diopters at 12 months .


Wavefront-guided eyes also achieved better best-corrected visual acuity at both the 5 % and 25 % contrast levels ( P = 0.022 and P = 0.004 , respectively ) .


There were no differences in levels of residual astigmatism ( P = 0.798 ) or in higher order aberrations ( P = 0.869 ) .


Both wavefront-guided and wavefront-optimized treatments are able to correct myopia safely and effectively in eyes with and without astigmatism .


However , wavefront-guided treatment platforms appear to offer significant advantages in terms of residual refractive error , uncorrected distance acuity and contrast sensitivity .


Impairments in mismatch negativity ( MMN ) generation have been consistently reported in patients with schizophrenia .


However , underlying oscillatory activity of MMN deficits in schizophrenia and the relationship with cognitive impairments have not been investigated in detail .


Time-frequency power and phase analyses can provide more detailed measures of brain dynamics of MMN deficits in schizophrenia .


21 patients with schizophrenia and 21 healthy controls were tested with a roving frequency paradigm to generate MMN .


Time-frequency domain power and phase-locking ( PL ) analysis was performed on all trials using short-time Fourier transforms with Hanning window tapering .


A comprehensive battery ( CANTAB ) was used to assess neurocognitive functioning .


Mean MMN amplitude was significantly lower in patients with schizophrenia ( 95 % CI 0.18 - 0.77 ) .


Patients showed significantly lower EEG power ( 95 % CI -1.02 - -0.014 ) in the ~ 4-7 Hz frequency range ( theta band ) between 170 and 210 ms. Patients with schizophrenia showed cognitive impairment in multiple domains of CANTAB .


However , MMN impairments in amplitude and power were not correlated with clinical measures , medication dose , social functioning or neurocognitive performance .


The findings from this study suggested that while MMN may be a useful marker to probe NMDA receptor mediated mechanisms and associated impairments in gain control and perceptual changes , it may not be a useful marker in association with clinical or cognitive changes .


Trial-by-trial EEG power analysis can be used as a measure of brain dynamics underlying MMN deficits which also can have implications for the use of MMN as a biomarker for drug discovery .


Despite the availability of new antibiotics such as daptomycin , methicillin-resistant Staphylococcus aureus ( MRSA ) bacteraemia continues to be associated with high clinical failure rates .


Combination therapy has been proposed as an alternative to improve outcomes but there is a lack of clinical studies .


The study aims to demonstrate that combination of daptomycin plus fosfomycin achieves higher clinical success rates in the treatment of MRSA bacteraemia than daptomycin alone .


A multicentre open-label , randomised phase III study .


Adult patients hospitalised with MRSA bacteraemia will be randomly assigned ( 1:1 ) to group 1 : daptomycin 10mg/kg/24h intravenous ; or group 2 : daptomycin 10mg/kg/24h intravenous plus fosfomycin 2gr/6g intravenous .


The main outcome will be treatment response at week 6 after stopping therapy ( test-of-cure ( TOC ) visit ) .


This is a composite variable with two values : Treatment success : resolution of clinical signs and symptoms ( clinical success ) and negative blood cultures ( microbiological success ) at the TOC visit .


Treatment failure : if any of the following conditions apply : ( 1 ) lack of clinical improvement at 72h or more after starting therapy ; ( 2 ) persistent bacteraemia ( positive blood cultures on day 7 ) ; ( 3 ) therapy is discontinued early due to adverse effects or for some other reason based on clinical judgement ; ( 4 ) relapse of MRSA bacteraemia before the TOC visit ; ( 5 ) death for any reason before the TOC visit .


Assuming a 60 % cure rate with daptomycin and a 20 % difference in cure rates between the two groups , 103 patients will be needed for each group ( :0.05 , : 0.2 ) .


Statistical analysis will be based on intention to treat , as well as per protocol and safety analysis .


The protocol was approved by the Spanish Medicines and Healthcare Products Regulatory Agency ( AEMPS ) .


The sponsor commits itself to publishing the data in first quartile peer-review journals within 12months of the completion of the study .


NCT01898338 .


Exacerbation of Graves ' orbitopathy ( GO ) after radioiodine ( RAI ) therapy has been examined in some populations but has not been fully described in Japanese populations .


The purpose of this study was to clarify the characteristics of GO exacerbation after RAI therapy and the effectiveness of low-dose prophylactic corticosteroid ( PCS ) .


This was a prospective randomized study in Tokyo , Japan .


Between June 2011 and June 2012 , 295 patients with Graves ' disease with either inactive GO or no GO received RAI therapy .


Of these , 147 received no PCS ( PCS-Off group ) , whereas 148 received low-dose PCS ( starting dose , 15 mg/day of prednisolone ) for 6 weeks ( PCS-On group ) .


We used magnetic resonance imaging to thoroughly evaluate GO before and 1 year after RAI therapy .


Outcomes of GO 1 year after RAI therapy were determined .


GO exacerbation occurred in 29 patients ( 9.8 % ) , and only 7 patients ( 2.4 % ) required ophthalmic treatment .


No significant difference in the frequency of GO exacerbation was seen between the groups ( PCS-On group : n = 18 [ 12.1 % ] ; PCS-Off group : n = 11 [ 7.5 % ] ; P = .17 ) .


Significant prognostic factors were identified as thyroid-stimulating antibody ( by 100 % linear increase : risk ratio , 1.15 ; 95 % confidence interval , 1.07-1 .24 ; P = .0003 ) and clinical activity score ( 1 vs 0 : risk ratio , 6.40 ; 95 % confidence interval , 2.17-19 .7 ; P = .0009 ) .


Exacerbation of GO after RAI therapy in the Japanese population appears less common than in other populations .


Low-dose PCS did not produce a significant preventive effect and appeared insufficient .


Patients presenting with risk factors would thus be recommended to receive higher-dose PCS .


Motives for use have been identified as important predictors of substance use and related problems ; however , little is known about how motives for use change following an intervention and how this change may impact future substance use behaviors .


The present study sought to describe change in motives following an intervention for marijuana-dependent adults .


Furthermore , investigators examined change in motives as a predictor of treatment outcome .


The study randomized 74 adults to one of two conditions : both of which received 9-sessions base treatment of cognitive behavioral therapy and motivational enhancement therapy and had access to additional sessions of cognitive behavioral treatment on an as-needed basis .


The experimental condition received two additional `` check-ups '' during the course of follow-up .


Significant decreases in reported frequency of motives used were observed following treatment .


Changes in Expansion and Coping were associated with differential treatment outcomes .


Decreases in Expansion were associated with poorer treatment outcome , while decreases in Coping were associated with better treatment outcome .


The relationship between expansion motives and outcomes was paradoxical .


Although there were some inconsistencies in the findings , the results regarding the coping motive were consistent with hypotheses and may have important implications for treatment .


The bile acid derivative 6-ethylchenodeoxycholic acid ( obeticholic acid ) is a potent activator of the farnesoid X nuclear receptor that reduces liver fat and fibrosis in animal models of fatty liver disease .


We assessed the efficacy of obeticholic acid in adult patients with non-alcoholic steatohepatitis .


We did a multicentre , double-blind , placebo-controlled , parallel group , randomised clinical trial at medical centres in the USA in patients with non-cirrhotic , non-alcoholic steatohepatitis to assess treatment with obeticholic acid given orally ( 25 mg daily ) or placebo for 72 weeks .


Patients were randomly assigned 1:1 using a computer-generated , centrally administered procedure , stratified by clinical centre and diabetes status .


The primary outcome measure was improvement in centrally scored liver histology defined as a decrease in non-alcoholic fatty liver disease activity score by at least 2 points without worsening of fibrosis from baseline to the end of treatment .


A planned interim analysis of change in alanine aminotransferase at 24 weeks undertaken before end-of-treatment ( 72 weeks ) biopsies supported the decision to continue the trial ( relative change in alanine aminotransferase -24 % , 95 % CI -45 to -3 ) .


A planned interim analysis of the primary outcome showed improved efficacy of obeticholic acid ( p = 00024 ) and supported a decision not to do end-of-treatment biopsies and end treatment early in 64 patients , but to continue the trial to obtain the 24-week post-treatment measures .


Analyses were done by intention-to-treat .


This trial was registered with ClinicalTrials.gov , number NCT01265498 .


Between March 16 , 2011 , and Dec 3 , 2012 , 141 patients were randomly assigned to receive obeticholic acid and 142 to placebo .


50 ( 45 % ) of 110 patients in the obeticholic acid group who were meant to have biopsies at baseline and 72 weeks had improved liver histology compared with 23 ( 21 % ) of 109 such patients in the placebo group ( relative risk 19 , 95 % CI 13 to 28 ; p = 00002 ) .


33 ( 23 % ) of 141 patients in the obeticholic acid developed pruritus compared with nine ( 6 % ) of 142 in the placebo group .


Obeticholic acid improved the histological features of non-alcoholic steatohepatitis , but its long-term benefits and safety need further clarification .


National Institute of Diabetes and Digestive and Kidney Diseases , Intercept Pharmaceuticals .


Strategies are needed to help general practitioners ( GPs ) promote smoking cessation as recommended by guidelines .


This study examines whether the quality of action planning among GPs improves their provision of smoking cessation care .


The effectiveness of a 1-h training programme was examined in a cluster randomised controlled trial in which 49 GPs participated .


GPs who followed the training ( intervention group ; n = 25 ) formulated action plans related to i ) enquiring about smoking , ii ) advising to quit smoking , and iii ) arranging follow-up for smokers motivated to quit .


GPs also formulated a coping plan for encountering smokers not motivated to quit .


The quality of these plans ( plan specificity ) was rated and , 6 weeks after the training , GPs reported on the performance of these plans ( plan enactment ) .


Multilevel regression analyses were used to examine the effects of plan specificity and plan enactment on patient-reported smoking cessation activities of the GPs in the intervention group ( n = 1,632 patients ) compared with the control group ( n = 1,769 patients ) .


Compared to the control group , GPs who formulated a highly specific action plan during the training asked their patients about smoking more often after the training compared to prior to the training ( OR 2.11 , 95 % CI 1.51-2 .95 ) .


GPs were most likely to have asked patients about smoking after the training compared to prior to the training when they had enacted a highly specific formulated action plan ( OR 3.08 , 95 % CI 2.04-4 .64 ) .


The effects of GP plan specificity and plan enactment on asking patient about smoking were most prominent among GPs who , at baseline , intended to provide smoking cessation care .


A highly specific action plan formulated by a GP on when , how , and by whom patients will be asked about smoking had a positive effect on GPs ' asking patients about smoking , especially when these professionals also reported to have enacted this plan .


This effect was most prominent among GPs who intended to provide smoking cessation care prior to the intervention .


Training in devising personalised coping plans is recommended to further increase GPs ' provision of advice to quit smoking and arranging follow-up support to quit smoking .


The preferred approach to the management of common bile duct ( CBD ) stones is uncertain , with single-stage laparoscopic cholecystectomy and CBD exploration vs. two-stage preoperative endoscopic CBD clearance followed by laparoscopic cholecystectomy being debated .


To address this , a prospective randomized study which compared these two management strategies was undertaken .


Between Jan 2002 and Dec 2005 , patients with gallstones and common bile duct stones diagnosed by preoperative ultrasonography and magnetic resonance cholangiopancreatography were randomized to single-stage vs. two-stage treatment .


In a single-stage group , laparoscopic cholecystectomy and CBD exploration were undertaken at the same operation , whereas in a two-stage group , endoscopic stone clearance was followed by laparoscopic cholecystectomy 2-5 days later .


Early treatment success and complications and longer-term follow-up for the two groups were compared .


Two hundred twenty-one patients were enrolled in the trial , 110 in the single-stage group and 111 in the two-stage group .


There was no significant difference in the success rate of CBD clearance ( 93.6 vs. 94.6 % , p = 0.76 ) or the complication rates ( 3.6 vs. 5.1 % , p = 0.527 ) between the groups .


However , at longer-term follow-up , recurrent CBD stones were seen more often in the two-stage group ( 9.5 vs. 2.1 % , p = 0.037 ) .


The single-stage and two-stage approaches were equally effective in achieving initial clearance of CBD stones .


However , recurrent CBD stones occurred more commonly in patients who had undergone two-stage treatment with initial endoscopic stone clearance , followed by laparoscopic cholecystectomy .


Amino-acid ( AA ) metabolic signatures differ in insulin-resistant ( IR ) obese vs normal-weight subjects , improve after weight loss , and seem to predict the risk of type 2 diabetes .


It is unknown whether weight-maintaining dietary measures aimed at influencing IR alter AA signatures of high-risk subjects .


In the randomized controlled Protein , Fiber and Metabolic Syndrome ( ProFiMet ) trial we investigated effects of four isoenergetic , moderately fat-reduced diets varying in protein and cereal-fiber contents on complete AA metabolic signatures in 76 group-matched overweight or obese high-risk subjects .


We analyzed the relation of whole-body and hepatic IR with AA signatures , body fat composition and liver fat , after 0 , 6 , and 18 weeks of dietary intervention .


Discrimination between diets was further enhanced by providing tailored dietary supplements for twice-daily consumption over 18 weeks in all groups .


Baseline AA , including branched-chain signatures significantly related to IR , liver fat , and visceral fat mass .


Isoenergetic variation of protein and cereal-fiber dietary contents , but not fat restriction , significantly influenced IR , whereas the relation of AA with IR changed with all diets .


The tryptophan ratio was significantly suppressed in obese vs overweight participants , but increased after 6 weeks of high cereal-fiber intake to a nonobese phenotype .


Modeling analyses revealed diet-induced alterations of complex AA profiles to relate to 70 % and 62 % of changes in whole-body and hepatic IR .


We demonstrate that relatively short-term isoenergetic changes in the diet significantly alter the relation of AA signatures with IR , with possible implications on the determination and treatment of diabetes risk .


Recently , men with intermediate-risk prostate cancer ( PC ) were classified into favorable and unfavorable categories ; however , whether the risk of PC-specific mortality ( PCSM ) among men with high-risk PC versus unfavorable intermediate-risk PC is increased is unknown .


In a prospective , randomized trial conducted between 1995 and 2001 , 206 men with intermediate-risk or high-risk PC were randomized to receive 70 Gy with or without 6 months of androgen-suppression therapy ( AST ) .


The subgroup of 197 patients with information available on the percentage of positive biopsies formed the cohort .


Fine and Gray regression analysis was used to assess whether men with high-risk PC versus unfavorable intermediate-risk PC had an increased risk of PCSM .


After a median follow-up of 14.3 years , there were 127 deaths ( 64.5 % ) , including 22 deaths ( 17.3 % ) from PC .


There were no PC deaths in the favorable intermediate-risk group .


There was an increase in the risk of PCSM among men with high-risk PC versus unfavorable intermediate-risk PC , but the difference was not significant ( adjusted hazard ratio , 1.59 ; 95 % confidence interval , 0.66-3 .83 ; P = .30 ) after adjusting for age , randomized treatment arm , and comorbidity .


The lack of PC deaths among men with favorable intermediate-risk PC suggests that adding AST may not reduce their risk of PCSM ; whereas many men with unfavorable intermediate-risk PC are at risk for harboring occult PC with Gleason scores from 8 to 10 and , if proven , would benefit from long-term AST .


Multiparametric magnetic resonance imaging and targeted biopsy of suspicious lesions should be considered to identify PC with Gleason scores from 8 to 10 in these men .


The purpose of this study was to demonstrate the activity of agmatine , an inducible nitric oxide synthase ( iNOS ) inhibitor and selective N-methyl-D-aspartate receptor ( NMDAR ) antagonist , on reducing tissue damage in distal part of traumatic nerve in an experimental rat peripheral nerve injury model .


Sciatic nerves of 30 Sprague Dawley male rats were used .


Rats were divided into 5 groups ; group 1 ( n = 6 ) , control group ; group 2 ( n = 6 ) , axonotmesis + placebo group ; group 3 ( n = 6 ) , axonotmesis + 50 mg/kg agmatine treatment group ; group 4 ( n = 6 ) , neurotmesis + placebo group ; group 5 ( n = 6 ) , neurotmesis + 50 mg/kg agmatine treatment group .


Axonolysis , axon degeneration , edema , hemorrhage , and inflammation were evaluated in histopathologic examinations of all the groups .


When group 2 was compared with group 3 in histopathologic sections , axonolysis was less in group 3 ( p = 0.007 ) , as was axon degeneration ( p = 0.022 ) and edema ( p = 0.018 ) .


When group 4 was compared with group 5 , axonolysis was less in group 5 ( p = 0.009 ) , as was axon degeneration ( p = 0.006 ) and edema ( p = 0.021 ) .


This study demonstrated agmatine to have antioxidant and antineurotoxic effects in an experimental rat peripheral nerve injury model .


Health-related quality of life is often collected in clinical studies , and forms a cornerstone of economic evaluation .


This study had two objectives , firstly to report and compare pre - and post-progression health state utilities in advanced melanoma when valued by different methods and secondly to explore the validity of progression-based health state utility modelling compared to modelling based upon time to death .


Utilities were generated from the ipilimumab MDX010-20 trial ( Clinicaltrials.gov Identifier : NCT00094653 ) using the condition-specific EORTC QLQ-C30 ( via the EORTC-8D ) and generic SF-36v2 ( via the SF-6D ) preference-based measures .


Analyses by progression status and time to death were conducted on the patient-level data from the MDX010-20 trial using generalised estimating equations fitted in Stata , and the predictive abilities of the two approaches compared .


Mean utility showed a decrease on disease progression in both the EORTC-8D ( 0.813 to 0.776 ) and the SF-6D ( 0.648 to 0.626 ) .


Whilst higher utilities were obtained using the EORTC-8D , the relative decrease in utility on progression was similar between measures .


When analysed by time to death , both EORTC-8D and SF-6D showed a large decrease in utility in the 180 days prior to death ( from 0.831 to 0.653 and from 0.667 to 0.544 , respectively ) .


Compared to progression status alone , the use of time to death gave similar or better estimates of the original data when used to predict patient utility in the MDX010-20 study .


Including both progression status and time to death further improved model fit .


Utilities seen in MDX010-20 were also broadly comparable with those seen in the literature .


Patient-level utility data should be analysed prior to constructing economic models , as analysis solely by progression status may not capture all predictive factors of patient utility and time to death may , as death approaches , be as or more important .


Additionally this study adds to the body of evidence showing that different scales lead to different health state values .


Further research is needed on how different utility instruments ( the SF-6D , EORTC-8D and EQ-5D ) relate to each other in different disease areas .


Recent technological advances in nebulization permit researchers to target specific parts of the lungs by modifying delivery method .


The aim of this study was to compare the central and peripheral targeted modalities of administration .


Lung and regional deposition of inhaled technetium-99m diethylene triamine penta-acetic was measured by scintigraphy after peripheral and central targeted modalities of administration with an Akita device in 6 healthy subjects .


Drug targeting nebulization delivered a large amount of drug into the peripheral part of the lung independent of the modality ( outer-to-inner deposition ratio of 1.24 0.21 vs. 1.22 0.14 for central and peripheral modalities , respectively ) , but there was no difference in lung deposition ( whole-body deposition , 83.3 6.5 % vs. 82.8 7.3 % , P = .86 ) or regional deposition ( P = .77 ) between both modalities .


The extrathoracic deposition was < 20 % of the whole-body deposition , without a difference between modalities ( P = .86 ) .


This study shows for the first time that choosing 2 different specific drug targeting nebulization modes does not influence the amount of drug delivered into the lung in healthy male subjects .


Moreover , the modes do not modify the site of deposition under the conditions of our study .


To assess whether an oxygen saturation ( Spo2 ) target of 85 % -89 % compared with 91 % -95 % reduced the incidence of the composite outcome of death or major disability at 2 years of age in infants born at < 28 weeks ' gestation .


A total 340 infants were randomized to a lower or higher target from < 24 hours of age until 36 weeks ' gestational age .


Blinding was achieved by targeting a displayed Spo2 of 88 % -92 % using a saturation monitor offset by 3 % within the range 85 % -95 % .


True saturations were displayed outside this range .


Follow-up at 2 years ' corrected age was by pediatric examination and formal neurodevelopmental assessment .


Major disability was gross motor disability , cognitive or language delay , severe hearing loss , or blindness .


The primary outcome was known for 335 infants with 33 using surrogate language information .


Targeting a lower compared with a higher Spo2 target range had no significant effect on the rate of death or major disability at 2 years ' corrected age ( 65/167 [ 38.9 % ] vs 76/168 [ 45.2 % ] ; relative risk 1.15 , 95 % CI 0.90-1 .47 ) or any secondary outcomes .


Death occurred in 25 ( 14.7 % ) and 27 ( 15.9 % ) of those randomized to the lower and higher target , respectively , and blindness in 0 % and 0.7 % .


Although there was no benefit or harm from targeting a lower compared with a higher saturation in this trial , further information will become available from the prospectively planned meta-analysis of this and 4 other trials comprising a total of nearly 5000 infants .


Insulin degludec/insulin aspart ( IDegAsp ) is the first combination of a basal insulin with an ultralong duration of action , and a rapid-acting insulin in a single injection .


This trial compared IDegAsp with biphasic insulin aspart 30 ( BIAsp 30 ) in adults with type 2 diabetes inadequately controlled with once - or twice-daily ( OD or BID ) pre - or self-mixed insulin with or without oral antidiabetic drugs .


In this 26-week , randomized , open-label , multinational , treat-to-target trial , participants ( mean age 58.7 years , duration of diabetes 13 years , BMI 29.3 kg/m ( 2 ) , and HbA1c 8.4 % [ 68 mmol/mol ] ) were exposed ( 1:1 ) to BID injections of IDegAsp ( n = 224 ) or BIAsp 30 ( n = 222 ) , administered with breakfast and the main evening meal and dose titrated to a self-measured premeal plasma glucose ( PG ) target of 4.0-5 .0 mmol/L .


After 26 weeks , mean HbA1c was 7.1 % ( 54 mmol/mol ) for both groups , with IDegAsp achieving the prespecified noninferiority margin for mean change in HbA1c ( estimated treatment difference [ ETD ] -0.03 % points [ 95 % CI -0.18 to 0.13 ] ) .


Treatment with IDegAsp was superior in lowering fasting PG ( ETD -1.14 mmol/L [ 95 % CI -1.53 to -0.76 ] , P < 0.001 ) and had a significantly lower final mean daily insulin dose ( estimated rate ratio 0.89 [ 95 % CI 0.83-0 .96 ] , P = 0.002 ) .


Fewer confirmed , nocturnal confirmed , and severe hypoglycemia episodes were reported for IDegAsp compared with BIAsp 30 .


IDegAsp BID effectively improves HbA1c and fasting PG levels with fewer hypoglycemia episodes versus BIAsp 30 in patients with uncontrolled type 2 diabetes previously treated with once - or twice-daily pre - or self-mixed insulin .


Excessive intravenous fluid prescription may play a causal role in postoperative complications following major gastrointestinal resectional surgery .


The aim of this study was to investigate whether fluid and salt restriction would decrease postoperative complications compared with a more modern controlled liberal regimen .


In this observer-blinded single-site randomized clinical trial consecutive patients undergoing major gastrointestinal resectional surgery were randomized to receive either a liberal control fluid regimen or a restricted fluid and salt regimen .


The primary outcome was postoperative complications of grade II and above ( moderate to severe ) .


Some 240 patients ( 194 colorectal resections and 46 oesophagogastric resections ) were enrolled in the study ; 121 patients were randomized to the restricted regimen and 119 to the control ( liberal ) regimen .


During surgery the control group received a median ( interquartile range ) fluid volume of 2033 ( 1576-2500 ) ml and sodium input of 282 ( 213-339 ) mmol , compared with 1000 ( 690-1500 ) ml and 142 ( 93-218 ) mmol respectively in the restricted group .


There was no significant difference in major complication rate between groups ( 380 and 390 per cent respectively ) .


Median ( range ) hospital stay was 8 ( 3-101 ) days in the controls and 8 ( range 3-76 ) days among those who received restricted fluids .


There were four in-hospital deaths in the control group and two in the restricted group .


Substantial differences in weight change , serum sodium , osmolality and urine : serum osmolality ratio were observed between the groups .


There were no significant differences in major complication rates , length of stay and in-hospital deaths when fluid restriction was used compared with a more liberal regimen .


ISRCTN39295230 ( http://www.controlled-trials.com ) .


Sample size calculations for treatment trials that aim to assess health-related quality-of-life ( HRQOL ) outcomes are often difficult to perform .


Researchers must select a target minimal clinically important difference ( MCID ) in HRQOL for the trial , estimate the effect size of the intervention , and then consider the responsiveness of different HRQOL measures for detecting improvements .


Generic preference-based HRQOL measures are usually less sensitive to gains in HRQOL than are disease-specific measures , but are nonetheless recommended to quantify an impact on HRQOL that can be translated into quality-adjusted life-years during cost-effectiveness analyses .


Mapping disease-specific measures onto generic measures is a proposed method for yielding more efficient sample size requirements while retaining the ability to generate utility weights for cost-effectiveness analyses .


This study sought to test this mapping strategy to calculate and compare the effect on sample size of three different methods .


Three different methods were used for determining an MCID in HRQOL in patients with incontinence : 1 ) a global rating of improvement , 2 ) an incontinence-specific HRQOL instrument , and 3 ) a generic preference-based HRQOL instrument using mapping coefficients .


The sample size required to detect a 20 % difference in the MCID for the global rating of improvement was 52 per trial arm , 172 per arm for the incontinence-specific HRQOL outcome , and 500 per arm for the generic preference-based HRQOL outcome .


We caution that treatment trials of conditions for which improvements are not easy to measure on generic HRQOL instruments will still require significantly greater sample size even when mapping functions are used to try to gain efficiency .


Sleep deprivation is common in critically ill patients in intensive care units ( ICU ) .


It can result in delirium , difficulty weaning , repeated nosocomial infections , prolonged ICU length of stay and increased ICU mortality .


Melatonin , a physiological sleep regulator , is well known to benefit sleep quality in certain people , but evidence for the effectiveness in ICU sleep disturbance is limited .


This study has a prospective , randomized , double-blind , controlled , parallel-group design .


Eligible patients are randomly assigned to one of the two treatment study groups , labelled the ` melatonin group ' or the ` placebo group ' .


A dose of 3 mg of oral melatonin or placebo is administered at 9:00 pm on four consecutive days .


Earplugs and eye masks are made available to every participant .


We plan to enrol 198 patients .


The primary outcome is the objective sleep quality measured by the 24-hour polysomnography .


The secondary outcomes are the subjective sleep quality assessed by the Richards Campbell Sleep Questionnaire , the anxiety level evaluated by the Visual Analogue Scale-Anxiety , the number of delirium-free days in 8 and 28 days , the number of ventilation-free days in 28 days , the number of antibiotic-free days , ICU length of stay , the overall ICU mortality in 28 days and the incidence and severity of the side effects of melatonin in ICU patients .


Additionally , the body stress levels , oxidative stress levels and inflammation levels are obtained via measuring the plasma melatonin , cortisone , norepinephrine , malonaldehyde ( MDA ) , superoxide dismutase ( SOD ) , interleukin-6 ( IL-6 ) and interleukin-8 ( IL-8 ) concentrations .


The proposed study will be the first randomized controlled study to use the polysomnography , which is the gold standard of assessing sleep quality , to evaluate the effect of melatonin on the sleep quality and circadian rhythms of ICU patients .


The results may recommend a new treatment for ICU patients with sleep deprivation that is safe , effective and easily implementable in daily practice .


This study was registered with ClinicalTrials ( NCT ; registration number : ChiCTR-TRC-14004319 ) on 4 March 2013 .


Various studies have linked the occurrence of cardiovascular events and low ambient temperatures as well as the morning blood pressure surge ( MBPS ) .


We hypothesized that low ambient temperatures produce a higher sympathetic change during the last rapid eye movement ( REM ) sleep transition and that this may play an important role in cold-related cardiovascular events .


All experiments were carried out on 12 healthy male adults , aged 24.000.74 years , who participated in two experimental conditions randomly ( > 1 day apart ) : warm ( 23 C ) and cold ( 16C ) .


Blood pressure ( BP ) was measured every 30 min for 24 h by autonomic ambulatory BP monitoring .


The electroencephalograms , electrocardiograms , ambient temperature , near-body temperature , and physical activity were recorded by miniature polysomnography for 24 h.