Using a Laerdal Advanced Life Support leak-free baby manikin and a 240-mL self-inflating bag , 58 neonatal staff members were randomly paired to provide mask ventilation , followed by mask ventilation with chest compressions with a 1:3 ratio , for two minutes each .


A Florian respiratory function monitor was used to measure respiratory mechanics , including mask leak .


The addition of chest compressions to mask ventilation led to a significant reduction in inflation rate , from 63.9 to 32.9 breaths per minute ( p < 0.0001 ) , mean airway pressure reduced from 7.6 to 4.9 cm H2 O ( p < 0.001 ) , minute ventilation reduced from 770 to 451 mL/kg/min ( p < 0.0001 ) , and there was a significant increase in paired mask leak of 6.8 % ( p < 0.0001 ) .


Adding chest compressions to mask ventilation , in accordance with the ILCOR guidelines , in a manikin model is associated with a significant reduction in delivered ventilation and increase in mask leak .


If similar findings occur in human infants needing an escalation in resuscitation , there is a potential risk of either delay in recovery or inadequate response to resuscitation .


We describe the design of the MERGE trial , a cluster randomised trial , to evaluate the effect of an intervention to optimise TB/HIV service integration on mortality , morbidity and retention in care among newly-diagnosed HIV-positive patients and newly-diagnosed TB patients .


Eighteen primary care clinics were randomised to either intervention or standard of care arms .


The intervention comprised activities designed to optimise TB and HIV service integration and supported by two new staff cadres-a TB/HIV integration officer and a TB screening officer-for 24 months .


A process evaluation to understand how the intervention was perceived and implemented at the clinics was conducted as part of the trial .


Newly-diagnosed HIV-positive patients and newly-diagnosed TB patients were enrolled into the study and followed up through telephonic interviews and case note abstractions at six monthly intervals for up to 18 months in order to measure outcomes .


The primary outcomes were incidence of hospitalisations or death among newly diagnosed TB patients , incidence of hospitalisation or death among newly diagnosed HIV-positive patients and retention in care among HIV-positive TB patients .


Secondary outcomes of the study included measures of cost-effectiveness .


Methodological challenges of the trial such as implementation of a complex multi-faceted health systems intervention , the measurement of integration at baseline and at the end of the study and an evolving standard of care with respect to TB and HIV are discussed .


The trial will contribute to understanding whether TB/HIV service integration affects patient outcomes .


The level of mutans streptococci ( MS ) is reduced by regularly consumption of probiotic Kefir drink .


The present study aiming at answer to this question ` may the Kefir drink be considered an alternative to fluoride rinse ? '


Twenty-two healthy volunteers aged 22-32 years with good oral hygiene participated in this study .


None of participants had received any antibiotic or antimicrobial agent or professional fluoride therapy within the last month .


None of them exhibited active caries lesions .


Smokers and subjects who have chewing gums xylitol habit or who were undergoing orthodontic treatment were excluded .


In a cross over design with 2 parallel groups , people in group A for 2 weeks received 100 ml of Kefir drink per day , then avoided brushing , eating and drinking for an hour .


Simultaneously , people in group B were administered 0.05 % sodium fluoride rinse in the same manner .


After washout period , people in groups A and B respectively used 0.05 % sodium fluoride rinse and Kefir drink .


Saliva sampling was performed before and after interventions .


The acidity and the count of MS were assessed and data were analyzed statistically .


There was no significant difference between base line pH values of saliva in study groups ( p > 0.05 ) .


Although , a significant difference was shown between MS counts before and after interventions ( p 0.0001 and p 0.0001 for NaF and Kefir respectively ) , but the equal inhibitory effect was found between study groups ( p > 0.05 ) .


Kefir drink can inhibit salivary MS as well the sodium fluoride rinse .


This beverage may be considered an alternative for fluoride rinse .


Clinical significance : Probiotics containing dairy products was known with anticariogenic properties .


These agents may be used in caries control strategies adjunctively .


To compare the therapeutic differences among scalp acupuncture combined with auricular point sticking , body acupuncture and western medication for treatment of vascular dementia ( VD ) .


Ninety cases were randomly divided into a combined therapy group ( 31 cases ) , a body acupuncture group ( 29 cases ) and a western medication group ( 30 cases ) .


The combined therapy group was treated with scalp acupuncture at forehead middle line , parieral middle line , temporal front line and temporal rear line as well as auricular point sticking at naogan ( AT3 ,41 ) , shen ( CO10 ) , shenmen ( TF4 ) , zhen ( AT3 ) , once a day ; the body acupuncture group was treated with acupuncture at Baihui ( GV 20 ) , Fengchi ( GB 20 ) , Zusanli ( ST 36 ) and so on , once a day ; the western medication group was treated with oral administration of aniracetam tablets , 0.2 g per time , twice a day .


Fourteen days were considered as a treatment course , and totally 3 courses were required .


The mini-mental state examination ( MMSE ) and activities of daily living ( ADL ) were applied to assess the changes of cognitive behavior ability before and after treatment among three groups .


Also the efficacy among three groups were compared .


One case dropped out in the body acupuncture group and western medication group , respectively .


The total effective rate was 90.334 ( 28/31 ) in the combined therapy group , which was superior to 85.734 ( 24/28 ) in the body acupuncture group and 79.3 % ( 23/29 ) in the western medication group ( both P < 0.05 ) .


After the treatment , the scores of MMSE and ADL were all improved among three groups , which was the most significant in the combined therapy group ( MMSE : 23.32 + / - 4.45 vs 21.23 + / - 4.13 , P < 0.05 ; 23.32 + / - 4.45 vs 20.41 + / - 4.01 , P < 0.01 ; ADL : 53.18 + / - 21.55 vs 51.92 + / - 20.42 , P < 0.05 ; 53.18 + / - 21.55 vs 49.42 + / - 19.43 , P < 0.01 ) .


The scalp acupuncture combined with auricular point sticking could improve the clinical symptoms and cognitive behavior ability in patients with vascular dementia , which has superior total efficacy to body acupuncture and western medication aniracetam tablets .


The study evaluated the efficacy of beclomethasone dipropionate/formoterol fumarate ( BDP/FF ) extrafine combination versus fluticasone propionate/salmeterol ( FP/S ) combination in COPD patients .


The trial was a 12-week multicentre , randomised , double-blind , double dummy study ; 419 patients with moderate/severe COPD were randomised to BDP/FF 200/12 g or FP/S 500/50 g twice daily .


The primary objective was to demonstrate the equivalence between treatments in terms of Transition Dyspnoea Index ( TDI ) score and the superiority of BDP/FF in terms of change from pre-dose in the first 30 minutes in forced expiratory volume in the first second ( FEV1 ) .


Secondary endpoints included lung function , symptom scores , symptom-free days and use of rescue medication , St. George 's Respiratory Questionnaire , six minute walking test and COPD exacerbations .


BDP/FF was equivalent to FP/S in terms of TDI score and superior in terms of FEV1 change from pre-dose ( p < 0.001 ) .


There were no significant differences between treatments in secondary outcome measures , confirming overall comparability in terms of efficacy and tolerability .


Moreover , a clinically relevant improvement ( > 4 units ) in SGRQ was detected in the BDP/FF group only .


BDP/FF extrafine combination provides COPD patients with an equivalent improvement of dyspnoea and a faster bronchodilation in comparison to FP/S .


ClinicalTrials.gov : NCT01245569 .


The main objective of the present study was to establish the relationships between CA-125 kinetics and tumour size changes during treatment .


The data from the CALYPSO-randomised phase III trial , comparing two platinum-based regimens in recurrent ovarian cancer ( ROC ) patients , was randomly split into a ` learning data set ' to estimate model parameters and a ` validation data set ' to validate model performances .


A kinetic-pharmacodynamic semi-mechanistic model was built to describe tumour size and CA-125 kinetics during chemotherapy .


The ability of the model to predict tumour response induced by chemotherapy , based on CA-125 values , was assessed .


Data from 535 ROC patients were used to model CA-125 kinetics and tumour size changes during the first 513 days after treatment initiation .


Using the validated model , we could predict with accuracy the tumour size changes induced by chemotherapy based on the baseline imaging assessment and longitudinal CA-125 values ( mean prediction error : 0.3 % , mean absolute prediction error : 10.6 % ) .


Using a semi-mechanistic model , the dynamic relationships between tumour size changes and CA-125 kinetics induced by chemotherapy were established in ROC patients .


A modelling approach allowed CA-125 to be assessed as a biomarker for tumour size dynamics , to predict treatment efficacy for research and clinical purposes .


To investigate the analgesic effect of repetitive transcranial magnetic stimulation ( rTMS ) on intractable neuropathic pain in patients with spinal cord injury ( SCI ) .


A single center , prospective , randomized , double-blinded , controlled study .


SCI rehabilitation unit of university rehabilitation center .


Seventeen patients with SCI and chronic neuropathic pain who met the inclusion criteria recruited between April 2010 and January 2012 .


Ten daily treatment sessions of real or sham rTMS ( 30 trains of 10-Hz stimuli for a duration of 5 seconds ; a total of 1500 pulses at intensity equal to 110 % of the resting motor threshold ) was applied over vertex using a gure-of-8-shaped coil .


Pain was assessed with visual analog scale ( VAS ) at baseline and 10 days , 6 weeks and 6 months after the treatment .


Patients ' satisfactions obtained using a 5-point Likert scale at 6 months .


Both real and sham rTMS provided a significant reduction in the VAS scores ( real rTMS group , P = 0.004 ; sham rTMS group , P = 0.020 ) .


Post hoc analysis revealed the significant difference was at 10 days and 6 weeks compared to baseline in the real rTMS group and only at 10 days compared to baseline in the sham rTMS group .


Comparison of VAS scores and patient satisfaction did not show any significant difference at each assessment point ( P > 0.05 ) .


Our results demonstrated analgesic effect of rTMS on intractable neuropathic pain in SCI was not superior to placebo .


However , middle-term ( over 6 weeks ) pain relief by rTMS is encouraging and suggests the need for future studies with a larger sample size .


Lymphocytes and natural killer cells ( NK ) appear to be important in colorectal cancer .


Their role in chemoradiotherapy for rectal cancers is unclear .


We evaluated T-lymphocytes ( CD3 ) , sub-groups CD4 and CD8 , and NK cells ( CD56 + CD57 ) in normal and rectal tumor tissues pre - and post-chemoradiotherapy , and investigated their relationship to tumor regression grade , disease-free survival and pathological stage .


Tissue microarrays from colonoscopic biopsies , resection specimens and normal tissues , from 52 patients , were immunostained .


NK cell counts were significantly lower in tumor samples compared to normal tissues ( p = 0.007 ) .


T-lymphocyte counts were higher in post-treatment compared to pre-treatment samples ( p = 0.025 ) , specifically in the CD8 subgroup after long-course treatment .


The results suggested an association between post-treatment CD8 and NK cell counts with higher tumor regression .


No associations were found with regard to stage or disease-free survival .


NK cell counts were significantly reduced in rectal cancers compared to normal tissues , while total T-lymphocyte counts increased post-chemoradiotherapy .


Both appeared important in tumor regression .


To observe the impacts on skeletal fluorosis pain , joint motor dysfunction and urine fluoride excretion in the treatment with fire needle therapy , electroacupuncture and calcium carbonate D3 .


The randomized controlled trial was adopted .


Ninety-five patients were randomized into a fire needle group ( 31 cases ) , an electroacupuncture group ( 33 cases ) and a calcium carbonate D3 group ( 31 cases ) .


In the fire needle group and the electroacupuncture group , Ashi points , Dazhui ( GV 14 ) , Geshu ( BL 17 ) , Quchi ( LI 11 ) , Hegu ( LI 4 ) , Xuehai ( SP 10 ) points were selected and stimulated with fire needle and electroacupuncture separately , three times a week .


In the calcium carbonate D3 group , calcium carbonate D3 tablets was prescribed for oral administration , 600 mg each time , twice a day .


The duration of treatment was 2 months in the electroacupuncture group and calcium carbonate D3 group and 1 month in the fire needle group .


VAS score , the range of motion ( ROM ) and urine fluoride value were compared before and after treatment in the patients of the three groups .


After treatment , VAS value and ROM were improved significantly in the patients of the three groups ( all P < 0.05 ) , the difference was not significant in comparison of the three groups ( all P > 0.05 ) .


After treatment , the urine fluoride value was increased significantly in the fire needle group [ ( 7.89 + / - 3.61 ) mg/L vs ( 9.81 + / - 4.17 ) mg/L , P < 0.01 ] and was increased in the electroacupuncture group [ ( 7.53 + / - 3.46 ) mg/L vs ( 8.97 + / - 4.21 ) mg/L , P < 0.05 ] .


The difference was not significant in comparison before and after treatment in the calcium carbonate D3 group ( P > 0.05 ) .


The fire needle therapy , electroacupuncture and calcium carbonate D3 all have the clinical value in the prevention and treatment of skeletal fluorosis and the difference in the therapeutic effect has not been discovered among them yet at present .


But it has been found that the fire needle therapy and electroacupuncture display the active significance in the promotion of urine fluoride excretion .


To observe the effect of Wenxin Granule ( WG ) on brain natriuretic peptide ( BNP ) and heart rate variability ( HRV ) of acute coronary syndrome ( ACS ) patients .


Totally 65 ACS patients were randomly assigned to the treatment group ( 35 cases ) and the control group ( 30 cases ) .


All patients were treated with routine therapies such as angiotensin conversing enzyme inhibitors ( ACEI ) and metoprolol .


Those in the treatment group took WG , 9 g each time , three times daily .


All were treated for 90 days .


Plasma samples of BNP and HRV were determined before treatment and after treatment .


There was no statistical difference in pre-treatment plasma BNP ( P > 0.05 ) .


Plasma BNP significantly decreased after treatment in the two groups when compared with before treatment ( P < 0.05 ) .


The decrease was more obvious in the treatment group ( P < 0.05 ) .


There was no statistical difference in pre-treatment HRV ( P > 0.05 ) .


Compared with before treatment in the same group , RMSSD , PNN50 % , and high frequency ( HF ) obviously increased , while low frequency ( LF ) and LF/HF ratio significantly decreased in the two groups , showing statistical difference ( P < 0.05 ) .


The aforesaid indices were obviously better in the treatment group than in the control group ( P < 0.05 ) .


Additional administration of WG could improve short-term clinical prognosis by down-regulating plasma BNP level ( via improving myocardial ischemia ) and modulating HRV .


To determine , in the setting of advanced-stage of Hodgkin lymphoma ( HL ) , whether relapses occur in the irradiated planning target volume and whether the definition of local radiation therapy ( RT ) used by the German Hodgkin Study Group ( GHSG ) is adequate , because there is no harmonization of field and volume definitions among the large cooperative groups in the treatment of advanced-stage HL .


All patients with residual disease of 2.5 cm after multiagent chemotherapy ( CTX ) were evaluated using additional positron emission tomography ( PET ) , and those with a PET-positive result were irradiated with 30 Gy to the site of residual disease .


We re-evaluated all sites of disease before and after CTX , as well as the PET-positive residual tumor that was treated in all relapsed patients .


Documentation of radiation therapy ( RT ) , treatment planning procedures , and portal images were carefully analyzed and compared with the centrally recommended RT prescription .


The irradiated sites were compared with sites of relapse using follow-up computed tomography scans .


A total of 2126 patients were enrolled , and 225 patients ( 11 % ) received RT. .


Radiation therapy documents of 152 irradiated patients ( 68 % ) were analyzed , with 28 irradiated patients ( 11 % ) relapsing subsequently .


Eleven patients ( 39 % ) had an in-field relapse , 7 patients ( 25 % ) relapsed outside the irradiated volume , and an additional 10 patients ( 36 % ) showed mixed in - and out-field relapses .


Of 123 patients , 20 ( 16 % ) with adequately performed RT relapsed , compared with 7 of 29 patients ( 24 % ) with inadequate RT. .


The frequency and pattern of relapses suggest that local RT to PET-positive residual disease is sufficient for patients in advanced-stage HL .


Insufficient safety margins of local RT may contribute to in-field relapses .


The purpose of this study was to investigate the remineralization activation of the application of three fissure sealants ( FSs ) , alone or with gaseous ozone ( GO ) , on non-cavitated initial caries and evaluate the clinical success of FS .


Sixty children who had DIAGNOdent scores between 10-30 on bilateral symmetric mandibular first permanent molars were included in study .


In a split-mouth design , teeth were assigned to experimental ( with GO ) and control ( without GO ) groups .


GO was applied to teeth on one side and then the same brand of randomly selected FSs was applied to the teeth on both sides .


Children were divided into 3 groups based on type of FS ( Group 1 : Aegis { Bosworth Co , North Hamlin Avenue Skokie , Illinois , USA } , Group 2 : Fuji Triage { GC , Tokyo , Japan } , Group 3 : Helioseal { Ivoclar Vivadent , Liechtenstein , Germany } ) .


All FSs were then examined for retention rates at 1 , 3 , 6 , 9 , and 12 months ; at the end of 12 months , all FSs were removed with an air-abrasion device and DIAGNOdent scores noted to compare with the initial values .


The application of GO with either Fuji Triage or Aegis FS was effective on remineralization ( p < 0.05 ) ; however , the application of Helioseal FSs was not effective ( p > 0.05 ) .


The 1 ( st ) and 12 ( th ) months ' full retention rates of Fuji Triage FSs was a significant difference ( p < 0.05 ) from other FSs ( Aegis and Helioseal ) ( p > 0.05 ) .


GO+A egis FS showed the highest remineralization ; and , at the end of 12 months , its clinical success was higher than other FSs .


We wish to assess the clinical and cost-effectiveness of remote monitoring of heart failure patients with cardiac implanted electronic devices .


REM-HF is a multicentre , randomized , non-blinded , parallel trial designed to compare weekly remote monitoring-driven management with usual care for patients with cardiac implanted electronic devices ( ICD , CRT-D , or CRT-P ) .


The trial is event driven , and the final analysis will be performed when 546 events have been observed or the study is terminated at the interim analysis .


We have randomized 1650 patients to be followed up for a minimum of 2 years .


Patients will remain in the trial up to study termination .


The first patient was randomized in September 2011 and the study is expected to complete in early 2016 .


The primary combined endpoint is time to first event of all-cause death or unplanned hospitalization for cardiovascular reasons .


An economic evaluation will be performed , estimating the cost per quality-adjusted life year , with direct costs estimated from the National Health Service perspective and quality of life assessed by the EQ-5D , Short-Form 12 , and Kansas City Cardiomyopathy Questionnaires .


The study design has been informed by a feasibility study .


REM-HF is a multicentre randomized study that will provide important data on the effect of remote monitoring-driven management of implanted cardiac devices on morbidity and mortality , as well as the cost-effectiveness of this approach .


We have previously shown that short sessions of whole body vibration ( WBV ) were not able to significantly improve fall risk among nursing home residents but some trends towards an improvement of motor capacity were observed .


The objective of the present study was to evaluate the impact of 6-month training by WBV on functional and motor abilities among nursing home residents observed over a 12-month period .


Patients were randomized into two groups : the WBV group which received three training sessions every week composed of five series of 15 s of vibration at 30 Hz intensity for a period of 6 months and a control group with normal daily life .


The impact of this training on the risk of falls was assessed blindly after 6 and 12 months by the Tinetti Test , the `` Timed Up and Go '' test and a quantitative evaluation of a 10-s walk performed with a tri-axial accelerometer .


The occurrence of falls was also observed .


62 elderly healthy volunteers , ( 47 women and 15 men , mean age 83.2 7.9 years ) were included in this study .


There was no significant difference between the two groups regarding the Tinetti test ( p = 0.75 ) , the `` Timed Up and Go '' test ( p = 0.19 ) and the Locomtrix ( ) test , except for the step length , measured by dual task ( p < 0.01 ) .


No significant inter-group difference in the frequency of falls was observed during the 12 months of research .


A total of 42 falls were recorded during the first 6 months of experimentation : 24 falls in the treated group and 18 in the control group ( p = 0.60 ) .


During the next 6 months , 19 falls occurred : 8 falls in the treated group and 11 in the control group ( p = 0.52 ) .


This study failed to establish the effectiveness of low doses of WBV , under the conditions used in our study , on functional and motor abilities of institutionalized elderly patients .


However , given the positive results of other studies , further investigations , with modified therapeutic protocols , seem necessary to clarify the effects of WBV in the elderly .


To determine the efficacy and safety of 2 doses of botulinum toxin type B ( rimabotulinumtoxinB , BoNT/B ) in spastic upper limb muscles .


Randomized , double-blind , placebo-controlled trial with a 3-month follow-up .


Tertiary care center .


Referred sample of adult hemiparetic patients ( N = 24 ) with disabling elbow flexor overactivity after stroke or traumatic brain injury .


Injection of 10,000 U of rimabotulinumtoxinB ( fixed 2500U dose into elbow flexors ; n = 8 ) , 15,000 U ( 5000U into elbow flexors ; n = 8 ) , or placebo ( n = 8 ) into overactive upper limb muscles selected as per investigator 's discretion .


At 1 month postinjection , active range of elbow extension ( goniometry ; primary outcome ) ; active upper limb function ( Modified Frenchay Scale [ MFS ] ) ; subjective global self-assessment ( GSA ) of arm pain , stiffness , and function ; rapid alternating elbow flexion-extension movement frequency over the maximal range ; elbow flexor spasticity grade and angle ( Tardieu ) , and tone ( Ashworth ) .


No adverse effects were associated with either BoNT/B dose .


Both doses improved active elbow extension versus placebo ( +8.3 ; 95 % confidence interval , 1.1-15 .5 ; analysis of covariance , P = .028 ) .


The high dose of BoNT/B also improved subject-perceived stiffness ( P = .005 ) and the composite pain , stiffness , and function GSA ( P = .017 ) , effects that persisted 3 months from injection .


No MFS change was demonstrated , although subjects with a baseline MFS < 70/100 seemed more likely to benefit from BoNT/B .


In this short-term study , BoNT/B up to 15,000 U into spastic upper limb muscles , including the elbow flexors , was well tolerated and improved active elbow extension and subject-perceived stiffness .


Posttraumatic stress disorder ( PTSD ) symptoms in individuals who have experienced repeated trauma ( sexual and/or physical ) in early childhood can lead to problems associated with emotion regulation , interpersonal functioning and self-image .


This so-called complex PTSD is often accompanied by a comorbid personality disorder .


Although ptsd is associated with structural and functional abnormalities in emotion-regulation areas in the brain , it is not known whether complex PTSD shows similar abnormalities .


Experts take the view that before individuals with complex PTSD are given appropriate therapy they should receive a course of emotion-regulation therapy such as the one tested by Zlotnick e.a. ( 1997 ) in a randomised controlled trial ( RCT ) .


To replicate Zlotnick 's RCT in the Netherlands and to find out whether complex PTSD patients show specific structural and functional brain abnormalities and whether psychological recovery is linked to the ` normalisation ' of these abnormalities .


In a RCT with complex PTSD patients ( n = 71 ) who had experienced trauma in early childhood , we compared normal individual treatment with treatment supported by ` Before and beyond ' , which consists of emotion-regulation therapy combined with cognitive group therapy .


In a subsample ( n = 33 ) we also performed an mri ( repeated , n = 9 ) in which individuals were required to execute an emotional memory and attention task .


In complex PTSD , structural abnormalities in the brain seemed to be more extensive than in PTSD and brain activity in complex PTSD seemed to be strikingly different from the brain activity seen in PTSD patients who had experienced only single trauma .


The results of the RCT indicate that ` Before and beyond ' is a clinically meaningful treatment ( with minimal drop-out ) for complex PTSD patients with a variety of personality disorders .


The psychological recovery of patients who received the emotion regulation and cognitive group treatment was associated with normalisation of brain function .


Treatment guidelines for ptsd patients can not be applied directly and automatically to complex PTSD because there is no scientific evidence to justify such a step .


The neurobiological profile of PTSD differs from that of complex PTSD .


Patients with complex PTSD seem to react favourably to emotion regulation therapy .


This treatment therefore could be a useful addition to the current PTSD guideline for this specific group .


There is a need for further research that focuses on complex PTSD patients .


Young children 's diets are currently suboptimal .


Given that mothers have a critical influence on children ' diets , they are typically a target of interventions to improve early childhood nutrition .


Understanding the maternal factors which mediate an intervention 's effect on young children 's diets is important , but has not been well investigated .


This research aimed to test whether maternal feeding knowledge , maternal feeding practices , maternal self-efficacy , and maternal dietary intakes acted as mediators of the effect of an intervention to improve child diet quality .


The Melbourne Infant Feeding Activity and Nutrition Trial ( InFANT ) Program was a cluster-randomized controlled trial , conducted from 2008-2010 .


This novel , low-dose , health promotion intervention was delivered quarterly over 15 months and involved educational activities , promotion of peer discussion , a DVD and written materials .


Post-intervention , when children were approximately 18 months of age , child diets were assessed using multiple 24-hour recalls and a purpose-developed index of diet quality , the Obesity Protective Dietary Index .


Maternal mediators were assessed using a combination of previously validated and purpose-deigned tools .


Mediation analysis was conducted using the test of joint significance and difference of coefficients methods .


Across 62 parents ' groups in Melbourne , Australia , 542 parents were recruited .


Post - intervention , higher maternal feeding knowledge and lower use of foods as rewards was found to mediate the direct intervention effect on child diet quality .


While other aspects of maternal feeding practices , self-efficacy and dietary intakes did not act as mediators , they were associated with child diet quality .


Mediation analysis of this novel health promotion intervention showed the importance of maternal feeding knowledge and use of foods as rewards in impacting child diet quality .


The other maternal factors assessed were appropriate targets but further research on how to impact these in an intervention is important .


This evidence of intervention efficacy and mediation provides important insights for planning future interventions .


Current Controlled Trials ISRCTN81847050 , registered 23 November 2007 .


To present our experience of a novel technique , bladder neck sling suspension technique , in patients undergoing robot-assisted radical prostatectomy ( RARP ) and evaluate its efficacy for improving early continence outcomes after RARP in comparison with that of the standard technique .


Fifty-seven consecutive patients underwent RARP between August 2011 and April 2012 .


We performed RARP with and without bladder neck sling suspension technique for 27 ( sling group ) and 30 ( nonsling group ) patients , respectively , and compared the urinary outcome between the groups .


Both subjective and objective assessments of urinary incontinence were performed before and after RARP .


The International Prostate Symptom Score ( P < .05 ) and International Consultation on Incontinence Questionnaire-Short Form ( P < .05 ) in the sling group were significantly lower , and Expanded Prostate Cancer Index Composite urinary incontinence score ( P < .05 ) in the sling group was higher than those in nonsling group , 4 weeks after RARP .


In addition , mean pad weight gain on 1-hour pad test in the sling group was significantly smaller than that in the nonsling group , 4 weeks after RARP ( P < .05 ) .


Both patient perception and objective data of urinary incontinence 4 weeks after RARP were better in the sling group than in the nonsling group .


Valsalva maneuver during cystography demonstrated that the mean posterior urethrovesical angle in the sling group was smaller than that in the nonsling group ( P < .001 ) .


Bladder neck sling suspension technique is a simple and feasible procedure in RARP and can improve the early return of continence after RARP , although additional larger studies are required to confirm this finding .


High sensitivity C-reactive protein ( hs-CRP ) , an inflammatory biomarker , has been demonstrated to contribute to the process of atherosclerosis and artery stenosis .


The aim of this study was to evaluate whether hs-CRP level is associated with asymptomatic intracranial artery stenosis ( ICAS ) .


A random sample of 5440 participants aged 40years or older ( 40.1 % women ) were enrolled in the Asymptomatic Polyvascular Abnormalities Community study in 2010-2011 .


Information on the potential risk factors for ICAS was collected and the presence of ICAS was assessed by transcranial Doppler in 5309 participants .


Participants were stratified into three groups according to hs-CRP levels .


A multivariate logistic regression was used to examine the association between hs-CRP levels and asymptomatic ICAS .


The prevalence of asymptomatic ICAS was 13.2 % in this cohort .


The median of hs-CRP levels was positively associated with the increasing numbers of ICASs .


After adjusting for possible risk factors , hs-CRP 3mg/l remained significantly associated with asymptomatic ICAS ( odds ratio 1.28 , 95 % confidence interval 1.02-1 .61 ) .


In this large community-based study , subjects with higher hs-CRP levels showed a mild increase in the prevalence of asymptomatic ICAS , independent of traditional vascular risk factors .


hs-CRP is an independent predictor of asymptomatic ICAS and intracranial atherosclerotic burden .


Diabetes and non-diabetic dysglycaemia are risk factors for accelerated cognitive decline .


In this planned substudy of the Outcome Reduction with Initial Glargine Intervention ( ORIGIN ) trial , we assessed whether normalising glucose with insulin glargine or administering omega-3 fatty acids in this population may slow this process or affect the development of cognitive impairment .


The ORIGIN trial recruited participants older than 50 years with dysglycaemia who were taking either no or one oral glucose-lowering drug , who had additional risk factors for cardiovascular events , whose HbA1c was less than 9 % , and who were not taking insulin .


Participants were recruited from 573 sites in 40 countries .


Participants were randomly assigned to either titrated basal insulin glargine targeting a fasting plasma glucose concentration of 5.3 mmol/L or lower or standard care and to either omega-3 fatty acid ( 1 g ) or placebo by a factorial design .


Outcome adjudicators and data analysts were masked to treatment allocation .


Cognitive function was assessed by the Mini-Mental State Examination ( MMS ) and Digit Symbol Substitution ( DSS ) .


The effect of insulin glargine or omega-3 fatty * acid on cognitive function over time , the annualised change in test scores , and the development of probable cognitive impairment were measured .


All analyses were restricted to those participants who had a cognitive measurement at both baseline and at least one follow-up visit .


The ORIGIN trial is registered with ClinicalTrials.gov , NCT00069784 .


Participants were randomly assigned between Sept 1 , 2003 , and Dec 15 , 2005 .


MMSE and DSS were assessed in 11,685 and 3392 ORIGIN participants ( mean age 63.4 years [ SD 7.7 ] ) , who were followed up for a median of 6.2 years ( IQR 5.8-6 .7 ) .


There was no difference in the rate of change of cognitive test scores between the insulin glargine and standard care groups ( for the MMSE 0.0046 , 95 % CI -0.0132 to 0.0224 , p = 0.39 ; and for the DSS -0.0362 , -0.2180 to 0.1455 , p = 0.34 ) or between the omega-3 fatty acid and placebo groups ( for the MMSE 0.0013 , 95 % CI -0.0165 to 0.0191 , p = 0.21 ; and for the DSS -0.0605 , -0.2422 to 0.1212 , p = 0.72 ) .


Similarly , the incidence of probable cognitive impairment did not differ between the insulin glargine and standard care groups ( p = 0.065 ) or the omega-3 fatty acid and placebo groups ( p = 0.070 ) .


In a subgroup analysis , allocation to insulin glargine versus standard care seemed to reduce the decline in the MMSE ( but not the DSS ) in participants with dysglycaemia but without evidence of diabetes ( pinteraction = 0.024 ) .


In this relatively young cohort of people with dysglycaemia , insulin mediated normoglycaemia and omega-3 fatty acid for over 6 years had a neutral effect on the rate of cognitive decline and on incident cognitive impairment .


Future studies should assess the effect of these interventions in an older cohort or the effect of other glucometabolic interventions on cognitive decline .


Sanofi .


Nomegestrol acetate ( NOMAC ) / 17-estradiol ( E2 ) is a monophasic oral contraceptive that contains a progesterone-derived progestogen ( NOMAC ) , and E2 , a bio-identical estrogen .


The primary objective of this thorough QT/QTc study was to investigate whether once-daily administration of therapeutic ( 2.5 / 1.5 mg ) and supratherapeutic ( 12.5 / 7.5 mg ) doses of NOMAC/E2 were associated with prolongation of the mean Fridericia-corrected QT ( QTcF ) interval in electrocardiograms at steady-state concentrations of NOMAC/E2 versus placebo .


The co-primary objective was to establish assay sensitivity after a single dose of moxifloxacin ( positive control ) .


This was a randomized , double-blind , parallel-group trial comparing 2.5 / 1.5 mg of NOMAC/E2 ( therapeutic dose ) , 12.5 / 7.5 mg of NOMAC/E2 ( supratherapeutic dose ) , placebo , and moxifloxacin 400 mg .


Double-blind study medication was administered from day -1 to 14 .


Healthy women aged 18-50 years were randomized .


The largest time-matched mean QTcF difference compared with placebo for the therapeutic dose of NOMAC/E2 was 1.6 ms , with an upper limit ( UL ) of a one-sided 95 % confidence interval ( CI ) of 5.2 ms , and 3.1 ms with an UL 95 % CI of 7.0 ms for the supratherapeutic dose .


The UL for the time-matched QTcF differences compared with placebo were below the 10 ms threshold defined in the ICH E14 guideline for all time points , both for the therapeutic and the supratherapeutic dose .


For moxifloxacin , assay sensitivity was demonstrated .


This thorough QT/QTc study showed that therapeutic and supratherapeutic doses of NOMAC/E2 were not associated with clinically relevant QTc interval prolongation in healthy women after a 2-week period of dosing .


Previous studies have demonstrated the potential beneficial effect of N-acetylcysteine ( NAC ) in chronic obstructive pulmonary disease ( COPD ) .


However , the required dose and responder phenotype remain unclear .


The current study investigated the effect of high-dose NAC on airway geometry , inflammation , and oxidative stress in COPD patients .


Novel functional respiratory imaging methods combining multislice computed tomography images and computer-based flow simulations were used with high sensitivity for detecting changes induced by the therapy .


Twelve patients with Global Initiative for Chronic Obstructive Lung Disease stage II COPD were randomized to receive NAC 1800 mg or placebo daily for 3 months and were then crossed over to the alternative treatment for a further 3 months .


Significant correlations were found between image-based resistance values and glutathione levels after treatment with NAC ( P = 0.011 ) and glutathione peroxidase at baseline ( P = 0.036 ) .


Image-based resistance values appeared to be a good predictor for glutathione peroxidase levels after NAC ( P = 0.02 ) , changes in glutathione peroxidase levels ( P = 0.035 ) , and reduction in lobar functional residual capacity levels ( P = 0.00084 ) .


In the limited set of responders to NAC therapy , the changes in airway resistance were in the same order as changes induced by budesonide/formoterol .


A combination of glutathione , glutathione peroxidase , and imaging parameters could potentially be used to phenotype COPD patients who would benefit from addition of NAC to their current therapy .


The findings of this small pilot study need to be confirmed in a larger pivotal trial .


To describe and compare characteristics of older adults who drive after drinking and those who do not , whether an intervention addressing at-risk drinking reduces risk among those reporting driving after drinking , and reasons reported for driving after drinking .


Secondary data analysis of a randomized trial testing the efficacy of a multifaceted intervention to reduce at-risk drinking among adults with a mean age of 68 years in primary care ( N = 631 ) .


Almost a quarter of at-risk drinkers reported driving after drinking ( N = 154 ) .


Compared to those who did not drive after drinking , those who did were more likely to be younger , male , and working .


They consumed a higher average number of drinks per week , had more reasons they were considered at-risk drinkers , and were more likely to meet at-risk drinking criteria due to amount of drinking and binge drinking .


Those driving after drinking at baseline reduced the frequency of this behavior at 3 and 12 months and there were no statistically significant differences in the proportions of persons still engaging in driving after drinking among those who were assigned to intervention or control groups .


Reasons for driving after drinking included not thinking that it was a problem and having to get home .


Driving after drinking is common in this population of older , at-risk drinkers recruited in primary care settings and , like younger adults , men and those reporting binge drinking are more likely to engage in this behavior .


Given that this behavior is dangerous and the population of older adults is fast growing , interventions addressing driving after drinking are needed .


Cost-effective guidance of therapeutic strategy in Crohn 's disease patients with secondary infliximab ( IFX ) treatment failure may be achieved by serum IFX and anti-IFX antibody ( Ab ) measurements by radioimmunoassay ( RIA ) .


This study investigated implications of using other techniques for this purpose .


This is a post hoc analysis of randomized clinical trial including 66 Crohn 's disease patients with IFX failure in whom IFX and anti-IFX Ab measurements by RIA had been used for therapeutic guidance .


Samples were additionally assessed by enzyme-linked immunosorbent assay ( ELISA ) , homogeneous mobility shift assay ( HMSA ) , and functional cell-based reporter gene assay ( RGA ) .


IFX detection was comparable between assays ( 82 % RIA , 76 % ELISA , 88 % HMSA , and 74 % RGA ) , and it correlated significantly ( Pearson 's r = 0.91-0 .97 , P < 0.0001 ) .


However , IFX concentrations varied systematically between all pair of assays except RIA-RGA .


Anti-IFX Ab detection was variable ( 27 % RIA , 9 % ELISA , 33 % HMSA , and 11 % RGA ) , but correlated significantly ( Pearson 's r = 0.77-0 .96 ; P < 0.0001 ) .


Anti-IFX Abs detected by RIA and HMSA were often from sera without drug-neutralizing activity ( RGA ) .


Assays agreed on classification of underlying mechanism for treatment failure in most cases ( 79-94 % ) .


The majority ( 74-88 % ) failed IFX owing to pharmacodynamic problems , or had noninflammatory pathophysiology for symptoms resembling relapse .


Applied threshold for therapeutic vs. subtherapeutic IFX level influenced classifications .


The four different assays did not differ in terms of the ability to predict response to interventions defined by the algorithm .


Despite variable analytical properties , common assays result in similar classifications and interventions in patients with IFX treatment failure , and with comparable clinical outcomes .


Implications are , however , profound for the minority classified differently .


Randomized clinical trial .


To examine the effectiveness of cervical traction in addition to exercise for specific subgroups of patients with neck pain .


Cervical traction is frequently used , but its effectiveness has not been adequately examined .


Existing studies have failed to target patients most likely to respond .


Traction is typically recommended for patients with cervical radiculopathy .


A prediction rule has been described to identify a narrower subgroup of patients likely to respond to cervical traction .


Patients with neck pain and signs of radiculopathy were randomized to 4 weeks of treatment with exercise , exercise with mechanical traction , or exercise with over-door traction .


Baseline assessment included subgrouping-rule status .


The primary outcome measure ( Neck Disability Index , scored 0-100 ) and secondary outcome measure ( neck and arm pain intensity ) were assessed at 4 weeks , 6 months , and 12 months after enrollment .


The primary analyses examined 2-way treatment-by-time interactions .


Secondary analyses examined validity of the subgrouping rule by adding 3-way interactions .


Eighty-six patients ( 53.5 % female ; mean age , 46.9 years ) were enrolled in the study .


Intention-to-treat analysis found lower Neck Disability Index scores at 6 months in the mechanical traction group compared to the exercise group ( mean difference between groups , 13.3 ; 95 % confidence interval : 5.6 , 21.0 ) and over-door traction group ( mean difference between groups , 8.1 ; 95 % confidence interval : 0.8 , 15.3 ) , and at 12 months in the mechanical traction group compared to the exercise group ( mean difference between groups , 9.8 ; 95 % confidence interval : 0.2 , 19.4 ) .


Secondary outcomes favored mechanical traction at several time points .


The validity of the subgrouping rule was supported on the Neck Disability Index at the 6-month time point only .


Adding mechanical traction to exercise for patients with cervical radiculopathy resulted in lower disability and pain , particularly at long-term follow-ups .


The study protocol was registered at http://clinicaltrials.gov ( NCT00979108 ) .


Nicotinic acetylcholine receptors ( nAChRs ) were identified on eosinophils and shown to regulate inflammatory responses , but nAChR expression on basophils has not been explored yet .


We investigated surface receptor expression of nAChR 4 , 7 and 1/3/5 subunits on basophils .


Furthermore , we examined the effects of ASM-024 , a synthetic nicotinic ligand , on in vitro anti-IgE and in vivo allergen-induced basophil activation .


Basophils were enriched from the peripheral blood of allergic donors and the expression of nAChR subunits and muscarinic receptors was determined .


Purified basophils were stimulated with anti-IgE in the presence of ASM-024 with or without muscarinic or nicotinic antagonists for the measurement of CD203c expression and histamine release .


The effect of 9 days of treatment with 50 and 200 mg ASM-024 on basophil CD203c expression was examined in the blood of mild allergic asthmatics before and after allergen inhalation challenge .


nAChR 4 , 7 and 1/3/5 receptor subunit expression was detected on basophils .


Stimulation of basophils with anti-IgE increased CD203c expression and histamine release , which was inhibited by ASM-024 ( 10 ( -5 ) to 10 ( - ) ( 3 ) M , p < 0.05 ) .


The effect of ASM-024 was reversed in the presence of muscarinic and nicotinic antagonists .


In subjects with mild asthma , ASM-024 inhalation significantly inhibited basophil CD203c expression measured 24 h after allergen challenge ( p = 0.03 ) .


This study shows that ASM-024 inhibits IgE - and allergen-induced basophil activation through both nicotinic and muscarinic receptors , and suggests that ASM-024 may be an efficacious agent for modulating allergic asthma responses .


Aprepitant is a neurokinin 1 receptor antagonist approved for prevention of chemotherapy-induced and post-operative nausea and vomiting .


Early studies demonstrated promising antidepressant activity as monotherapy , although this was unsupported by subsequent phase 3 trials .


This phase 2 study evaluated whether aprepitant potentiated the antidepressant effects of paroxetine .


Outpatients with major depressive disorder were randomized to aprepitant 200 mg + paroxetine 20 mg , paroxetine + placebo , or aprepitant + placebo for 6 weeks .


The primary endpoint was change in HAMD-17 total score .


Secondary/exploratory endpoints included changes in HAMA , CGI-S , CGI-I , and HAMD Item-1 scores at week 6 .


A total of 79 , 78 , and 79 patients received aprepitant + paroxetine , paroxetine + placebo , and aprepitant + placebo , respectively .


At week 6 , mean changes in HAMD-17 were -11.0 ( 95 % confidence interval [ CI ] : -12.7 , -9.4 ) , -11.7 ( 95 % CI : -13.3 , -10.0 ) , and -9.5 ( 95 % CI : -10.9 , -8.1 ) , respectively .


Pairwise comparisons of HAMD-17 change with combination therapy versus paroxetine alone demonstrated no significant difference ( p = 0.567 ) .


Changes in CGI-S , CGI-I , and HAMD Item-1 scores were also comparable , although there was a greater reduction in anxiety ( HAMA ) with paroxetine alone than aprepitant + paroxetine ( p = 0.045 ) .


Adverse events were generally more common with the combination than either monotherapy .


Concomitant use of aprepitant + paroxetine for 6 weeks did not provide greater antidepressant benefit compared with paroxetine + placebo in patients with major depression .


A recent systematic review suggests that practice facilitation ( PF ) is a robust intervention for implementing evidence-based preventive care guidelines in primary care , but the ability of PF to improve chronic illness care remains unclear .


To examine the specific activities and Chronic Care model ( CCM ) components that primary care practices implemented and sustained in response to a 12-month PF intervention .


The ABC trial tested the effectiveness of PF to improve care for diabetes in 40 small community-based primary care practices that were randomized to `` initial '' or `` delayed '' intervention arms .


A trained facilitator met with each practice over 12-months .


Facilitators used interactive consensus building to help practices implement one or more of quality improvement activities based on the CCM .


Facilitators prospectively recorded implementation activities reported by practice teams during monthly meetings and confirmed which of these were sustained at the end of the intervention .


37 practices implemented and sustained a total of 43 unique activities [ range 1-15 , average 6.5 ( SD = 2.9 ) ] .


The number ( % ) of practices that implemented 1 or more key activities in each CCM component varied : Patient Self-Management Support : 37 ( 100 % ) ; Clinical Information Systems : 24 ( 64.9 % ) , Delivery System Design : 14 ( 37.8 % ) , Decision Support : 13 ( 35.1 % ) , Community Linkages : 2 ( 5.4 % ) ; Healthcare System Support : 2 ( 2.7 % ) .


The majority of practices ( 59 % ) only implemented activities from 1 or 2 CCM components .


The number of sustained activities was associated with the number of PF visits , but not with practice characteristics .


In spite of the PF intervention , it was difficult for these small practices to implement comprehensive CCM changes .


Although practices implemented and sustained a remarkable number and variety of key activities , the majority of these focused on patient self-management support , as opposed to other components of the CCM , such as clinical information systems , decision support , delivery system redesign , and community linkages .


To demonstrate the superiority of estradiol valerate plus dienogest ( E ( 2 ) V/DNG ) over ethinylestradiol plus levonorgestrel ( EE/LNG ) in reducing the number of days with dysmenorrheic pain among women with primary dysmenorrhea .


In a phase IIIb trial conducted at 44 centers worldwide between April 2009 and November 2010 , otherwise healthy women aged 14-50 years requesting contraception were randomized to daily oral administration of E ( 2 ) V/DNG ( n = 253 ) or EE/LNG ( n = 254 ) for three 28-daycycles .


The primary efficacy variable was number of days with dysmenorrheic pain , the category of which ( none , mild , moderate , severe ) was self-assessed on a daily basis ( irrespective of menstrual bleeding status ) and recorded on diary cards .


Notably , the women documented their pain as they experienced it before taking any ( permitted ) rescue medication .


Overall , 217 and 209 women receiving E ( 2 ) V/DNG and EE/LNG , respectively , completed the study .


The mean SD change from baseline in number of days with dysmenorrheic pain was -4.6 4.6 days and -4.2 4.2 days for the E ( 2 ) V/DNG and EE/LNG groups , respectively ( P = 0.34 ) .


Both E ( 2 ) V/DNG and EE/LNG led to considerable relief of dysmenorrheic complaints among women with primary dysmenorrhea , decreasing the number of days with dysmenorrheic pain from baseline to a similar extent .


ClinicalTrials.gov : NCT00909857 .


Treating anaemia with red blood cell ( RBC ) transfusion is frequent , but controversial , in patients with septic shock .


Therefore we assessed characteristics and outcome associated with RBC transfusion in this group of high risk patients .


We did a prospective cohort study at 7 general intensive care units ( ICUs ) including all adult patients with septic shock in a 5-month period .


Ninety-five of the 213 included patients ( 45 % ) received median 3 ( interquartile range 2-5 ) RBC units during shock .


The median pre-transfusion haemoglobin level was 8.1 ( 7.4-8 .9 ) g/dl and independent of shock day and bleeding .


Patients with cardiovascular disease were transfused at higher haemoglobin levels .


Transfused patients had higher Simplified Acute Physiology Score ( SAPS ) II ( 56 ( 45-69 ) vs. 48 ( 37-61 ) , p = 0.0005 ) , more bleeding episodes , lower haemoglobin levels days 1 to 5 , higher Sepsis-related Organ Failure Assessment ( SOFA ) scores ( days 1 and 5 ) , more days in shock ( 5 ( 3-10 ) vs. 2 ( 2-4 ) , p = 0.0001 ) , more days in ICU ( 10 ( 4-19 ) vs. 4 ( 2-8 ) , p = 0.0001 ) and higher 90-day mortality ( 66 vs. 43 % , p = 0.001 ) .


The latter association was lost after adjustment for admission category and SAPS II and SOFA-score on day 1 .


The decision to transfuse patients with septic shock was likely affected by disease severity and bleeding , but haemoglobin level was the only measure that consistently differed between transfused and non-transfused patients .


For patients with neuromuscular disorders , lung insufflation with positive pressure is an accepted technique to increase inspiratory volume over VC to improve peak cough flow ( PCF ) .


The aim of the study was to determine the pressure or volume required to achieve the highest individual PCF .


In 40 patients dependent on noninvasive ventilation ( VC , 1611 % predicted ; age , 204 yr ) and in 20 healthy control subjects , insufflation capacity ( IC ) was measured during titration from 10 to maximum 40 mbar using intermittent positive pressure breathing ( IPPB ) or the lung insufflation assist maneuver ( LIAM ) of the VENTIlogic LS ventilator .


IPPB or LIAM titration resulted in a pressure-volume curve with an estimated total compliance of 0.230.11 L/kPa in the patients and 1.00.3 L/kPa in the controls and a plateau for IC at pressures between 30 and 40 mbar .


IPPB or LIAM improved VC from 451229 ml to a maximum IC ( ICmax ) of 1,027329 ml , and PCF improved from 10945 to 20262 L/min ( P < 0.01 for all ) .


The highest individual PCF was achieved with 276 mbar and an IC of 924379 ml , which was significantly below ICmax ( P < 0.01 ) .


A submaximal insufflation is ideal for generating the best individual PCF even in patients with severely reduced compliance of the respiratory system .


Optimum insufflation capacity can be achieved using IPPB or LIAM with moderate pressures .


Both techniques are equally effective and considered safe .


To increase the safety and effectiveness of treatments for overactive bladder ( OAB ) with moderate symptoms in elderly patients .


Patients were examined at the Urodynamic Department of the Regional Diagnostic Center ( Vladivostok , Russian Federation ) from September 1 , 2012 to December 31 , 2012 .


The assignment of patients [ n = 177 , average age 69.4 years , 98 women ( 55.4 % ) and 79 men ( 44.6 % ) ] was random and blind in this placebo-controlled study .


Patients were distributed into subgroups according to the method of treatment as follows : group 1 : n = 57 , trospium 30 mg/day + solifenacin 10 mg/day ; group 2 : n = 61 , trospium 15 mg/day + solifenacin 5 mg/day ; group 3 : n = 59 , placebo .


All patients underwent a urodynamic examination in accordance with international standards before and 2 months after treatment .


ICIQ-SF questionnaires recommended by the International Continence Society ( ICS ) and bladder diaries were used to evaluate the clinical results .


The clinical severity of the OAB symptoms and the effectiveness of the treatment were evaluated based on the frequency of episodes of incontinence ( EI ) per day .


Three or fewer EI per day were considered moderate dysfunction of the lower urinary tract .


Groups of elderly patients with moderate symptoms of OAB who were treated with standard - and low-dose trospium and solifenacin demonstrated a significant increase in the median values of reflex volume , bladder capacity , and detrusor compliance and a decrease in the frequency of urination and urinary urgencies .


The frequency of EI in both of the main groups decreased by almost 2-fold in comparison to the initial data and reached the following values : group 1 : 1.27 ( -1.08 ) , p 0.05 ; group A2 : 1.49 ( -1.18 ) , p 0.05 .


The correlation with the decrease in the frequency of EI in these groups was r = 0.85 ( p 0.01 ) .


The percentage of patients with a significant decrease ( EI 1.0 ) among those treated with standard - and low-dose trospium and solifenacin increased synchronously , prompting us to suppose the absence of a direct correlation between medicine dose and therapeutic effect for moderate OAB symptoms .


The combination of low-dose trospium and solifenacin provides good clinical and urodynamic effects in elderly patients with moderate symptoms of OAB .


Combination of these drugs in standard doses for such patients is excessive .


Resistance to trastuzumab is a problem that remains to be solved in HER2-positive breast cancer .


We aimed to characterize profiles of genetic and epigenetic alterations in cancer-related pathways in HER2-positive breast cancers , using biopsy tissue samples obtained from patients enrolled in a prospective neoadjuvant clinical trial .


HER2-positive breast cancer tissue samples were collected and processed with the PAXgene Tissue System .


A total of 24 breast cancers were analyzed .


Genetic alterations of 409 cancer-related genes were analyzed by a bench-top next-generation sequencer .


DNA methylation statuses were analyzed by a bead array with 485,512 probes .


The WNT pathway was potentially activated by aberrant methylation of its negative regulators , such as DKK3 and SFRP1 , in 9 breast cancers .


The AKT/mTOR pathway was activated by mutations of PIK3CA in 5 breast cancers .


The Notch pathway was potentially activated by mutations of NOTCH1 and NOTCH2 in 4 breast cancers .


The p53 pathway was inactivated by mutations of TP53 in 13 breast cancers and potentially by aberrant methylation of its downstream genes in 10 breast cancers .


Cell adhesion was affected by mutations of CDH1 in 1 breast cancer .


Genes involved in cancer-related pathways were frequently affected not only by genetic but also by epigenetic alterations in HER2-positive breast cancer .


Interventions are needed to reduce poor perinatal health .


We trained community health workers ( CHWs ) as home visitors to address maternal/infant risks .


In a cluster randomised controlled trial in Cape Town townships , neighbourhoods were randomised within matched pairs to 1 ) the control , healthcare at clinics ( n = 12 neighbourhoods ; n = 594 women ) , or 2 ) a home visiting intervention by CBW trained in cognitive-behavioural strategies to address health risks ( by the Philani Maternal , Child Health and Nutrition Programme ) , in addition to clinic care ( n = 12 neighbourhoods ; n = 644 women ) .


Participants were assessed during pregnancy ( 2 % refusal ) and 92 % were reassessed at two weeks post-birth , 88 % at six months and 84 % at 18 months later .


We analysed 32 measures of maternal/infant well-being over the 18 month follow-up period using longitudinal random effects regressions .


A binomial test for correlated outcomes evaluated overall effectiveness over time .


The 18 month post-birth assessment outcomes also were examined alone and as a function of the number of home visits received .


Benefits were found on 7 of 32 measures of outcomes , resulting in significant overall benefits for the intervention compared to the control when using the binomial test ( p = 0.008 ) ; nevertheless , no effects were observed when only the 18 month outcomes were analyzed .


Benefits on individual outcomes were related to the number of home visits received .


Among women living with HIV , intervention mothers were more likely to implement the PMTCT regimens , use condoms during all sexual episodes ( OR = 1.25 ; p = 0.014 ) , have infants with healthy weight-for-age measurements ( OR = 1.42 ; p = 0.045 ) , height-for-age measurements ( OR = 1.13 , p < 0.001 ) , breastfeed exclusively for six months ( OR = 3.59 ; p < 0.001 ) , and breastfeed longer ( OR = 3.08 ; p < 0.001 ) .


Number of visits was positively associated with infant birth weight 2500 grams ( OR = 1.07 ; p = 0.012 ) , healthy head-circumference-for-age measurements at 6 months ( OR = 1.09 , p = 0.017 ) , and improved cognitive development at 18 months ( OR = 1.02 , p = 0.048 ) .


Home visits to neighbourhood mothers by CHWs may be a feasible strategy for enhancing maternal/child outcomes .


However , visits likely must extend over several years for persistent benefits .


ClinicalTrials.gov NCT00996528 .


We have reported , in a randomized , controlled study , that tegafur-uracil ( UFT ) and protein-bound polysaccharide K ( PSK ) combination therapy significantly improves the 5-year disease-free survival rate and reduces the risk of recurrence compared to UFT alone for Stage II or III colorectal cancer .


In this study , we examined the efficacy of PSK by stratifying patients according to the preoperative lymphocyte ratio ( Lym ) .


In a randomized , controlled study , 205 patients were eligible ( 137 in the UFT/PSK group and 68 in the UFT group ) .


Of these , 193 patients with available preoperative Lym data were analysed ( 131 in the UFT/PSK group and 62 in the UFT group ) .


Among patients with a preoperative Lym of < 35 % , the relapse-free survival ( RFS ) rate was 76.5 % in the UFT/PSK group and 55.8 % in the UFT group ( p = 0.008 ) .


However , in patients with a preoperative Lym of 35 % , the RFS rate did not differ between the 2 groups .


Similarly , overall survival was significantly higher in the UFT/PSK group than in the UFT group in patients with a preoperative Lym of < 35 % , whereas no intergroup difference was found among patients with a preoperative Lym of 35 % .


This study suggests that a low preoperative Lym is a good predictor for response to PSK in patients with Stage II or III colorectal cancer .


Persistent postsurgical pain ( PPP ) after thoracotomy effect 50 % to 80 % .


Nerve damage and central sensitization involving NDMDAr activation may play an important role .


This study evaluates the efficacy of adding intravenous ( IV ) or epidural ketamine to thoracic epidural analgesia ( TEA ) after thoracotomy .


Double-blind randomized study on patients undergoing thoracotomy allocated to one of the following : group Kiv ( IV racemic ketamine 0.5 mg/kg preincisional +0.25 mg/kg/h for 48 h ) , group Kep ( epidural racemic ketamine 0.5 mg/kg preincisional +0.25 mg/kg/h for 48 h ) , or group S ( saline ) .


Postoperative analgesia was ensured by TEA with ropivacaine and fentanyl .


Pain visual analog scales ( VAS ) , Neuropathic Pain Symptom Inventory , Catastrophizing Scale , and Quantitative Sensory Testing , measuring both the peri-incisional and distant hyperalgesia area , were conducted preoperatively and postoperatively until 6 months .


Plasma ketamine levels and stability of the analgesic solutions were analyzed .


A total of 104 patients were included .


PPP incidence was 20 % at 6 months .


Pain scores on coughing were significantly lower in Kiv and Kep than in S at 24 and 72 hours , but there were no differences afterwards .


There were no significant differences in pain at rest , Neuropathic Pain Symptom Inventory , and Catastrophizing Scale , or in the area of mechanical allodynia at any time .


Adverse effects were mild .


Plasma ketamine levels did not differ significantly between groups .


Analgesic solutions were stable .


Adding epidural or IV racemic ketamine to TEA after thoracotomy did not lead to any reduction in PPP or allodynia .


Epidural administration produced similar plasma ketamine levels to the IV route .


Whether current postoperative surveillance regimes result in improved overall survival ( OS ) of patients with extremity sarcomas is unknown .


We hypothesized that a less intensive followup protocol would not be inferior to the conventional followup protocol in terms of OS .


We ( 1 ) assessed OS of patients to determine if less intensive followup regimens led to worsened survival and asked ( 2 ) whether chest radiograph followup group was inferior to CT scan followup group in detecting pulmonary metastasis ; and ( 3 ) whether less frequent ( 6-monthly ) followup interval was inferior to more frequent ( 3-monthly ) followup in detecting pulmonary metastasis and local recurrence .


A prospective randomized single-center noninferiority trial was conducted between January 2006 and June 2010 .


On the basis of 3-year survival of 60 % with intensive , more frequent followup , 500 nonmetastatic patients were randomized to demonstrate noninferiority by a margin ( delta ) of 10 % ( hazard ratio [ HR ] , 1.36 ) .


The primary end point was OS at 3years .


The secondary objective was to compare disease-free survival ( DFS ) ( time to recurrence ) at 3years .


At minimum followup of 30months ( median , 42months ; range , 30-81months ) , 178 deaths were documented .


Three-year OS and DFS for all patients was 67 % and 52 % , respectively .


Three-year OS was 67 % and 66 % in chest radiography and CT groups , respectively ( HR , 0.9 ; upper 90 % confidence interval [ CI ] , 1.13 ) .


DFS rate was 54 % and 49 % in chest radiography and CT groups , respectively ( HR , 0.82 ; upper 90 % CI , 0.97 ) .


Three-year OS was 64 % and 69 % in 6-monthly and 3-monthly groups , respectively ( HR , 1.2 ; upper 90 % CI , 1.47 ) .


DFS was 51 % and 52 % in 6-monthly and 3-monthly groups , respectively ( HR , 1.01 ; upper 90 % CI , 1.2 ) .


Almost 90 % of local recurrences were identified by patients themselves .


Inexpensive imaging detects the vast majority of recurrent disease in patients with sarcoma without deleterious effects on eventual outcomes .


Patient education regarding self-examination will detect most instances of local recurrence although this was not directly assessed in this study .


Although less frequent visits adequately detected metastasis and local recurrence , this trial could not conclusively demonstrate noninferiority in OS for a 6-monthly interval of followup visits against 3-monthly visits .


Level I , therapeutic study .


See Guidelines for Authors for a complete description of levels of evidence .


An elevated heart rate is an established marker of cardiovascular risk .


Previous analyses have suggested that ivabradine , a heart-rate-reducing agent , may improve outcomes in patients with stable coronary artery disease , left ventricular dysfunction , and a heart rate of 70 beats per minute or more .


We conducted a randomized , double-blind , placebo-controlled trial of ivabradine , added to standard background therapy , in 19,102 patients who had both stable coronary artery disease without clinical heart failure and a heart rate of 70 beats per minute or more ( including 12,049 patients with activity-limiting angina [ class II on the Canadian Cardiovascular Society scale , which ranges from I to IV , with higher classes indicating greater limitations on physical activity owing to angina ] ) .


We randomly assigned patients to placebo or ivabradine , at a dose of up to 10 mg twice daily , with the dose adjusted to achieve a target heart rate of 55 to 60 beats per minute .


The primary end point was a composite of death from cardiovascular causes or nonfatal myocardial infarction .


At 3 months , the mean ( SD ) heart rate of the patients was 60.79.0 beats per minute in the ivabradine group versus 70.610.1 beats per minute in the placebo group .


After a median follow-up of 27.8 months , there was no significant difference between the ivabradine group and the placebo group in the incidence of the primary end point ( 6.8 % and 6.4 % , respectively ; hazard ratio , 1.08 ; 95 % confidence interval , 0.96 to 1.20 ; P = 0.20 ) , nor were there significant differences in the incidences of death from cardiovascular causes and nonfatal myocardial infarction .


Ivabradine was associated with an increase in the incidence of the primary end point among patients with activity-limiting angina but not among those without activity-limiting angina ( P = 0.02 for interaction ) .


The incidence of bradycardia was higher with ivabradine than with placebo ( 18.0 % vs. 2.3 % , P < 0.001 ) .


Among patients who had stable coronary artery disease without clinical heart failure , the addition of ivabradine to standard background therapy to reduce the heart rate did not improve outcomes .


( Funded by Servier ; SIGNIFY Current Controlled Trials number , ISRCTN61576291 . )


Providing care for adolescents with type 1 diabetes is complex , demanding , and often unsuccessful .


Guided self-determination ( GSD ) is a life skills approach that has been proven effective in caring for adults with type 1 diabetes .


To improve care , GSD was revised for adolescents , their parents , and interdisciplinary healthcare providers ( HCP ) to create GSD-Youth ( GSD-Y ) .


We evaluated the impact of GSD-Y after it was integrated into pediatric outpatient visits versus treatment-as-usual , focusing on glycemic control and the development of life skills in adolescents with type 1 diabetes .


Seventy-one adolescents ( mean age : 15 years , mean duration of diabetes : 5.7 years , mean HbA1c : 77 mmol/mol ( 9.1 % ) , upon entering the study ) from two pediatric departments were randomized into a GSD-Y group ( n = 37 , GSD-Y was provided during individual outpatient sessions ) versus a treatment-as-usual group ( n = 34 ) .


The primary outcome was the HbA1c measurement .


The secondary outcomes were life skills development ( assessed by self-reported psychometric scales ) , self-monitored blood glucose levels , and hypo - and hyperglycemic episodes .


The analysis followed an intention-to-treat basis .


Fifty-seven adolescents ( 80 % ) completed the trial , and 53 ( 75 % ) completed a six-month post-treatment follow-up .


No significant effect of GSD-Y on the HbA1c could be detected in a mixed-model analysis after adjusting for the baseline HbA1c levels and the identity of the HCP ( P = 0.85 ) .


GSD-Y significantly reduced the amotivation for diabetes self-management after adjusting for the baseline value ( P = 0.001 ) .


Compared with the control group , the trial completion was prolonged in the GSD-Y group ( P < 0.001 ) , requiring more visits ( P = 0.05 ) with a higher rate of non-attendance ( P = 0.01 ) .


GSD-Y parents participated in fewer of the adolescents ' visits ( P = 0.05 ) compared with control parents .


Compared with treatment-as-usual , GSD-Y did not improve HbA1c levels , but it did decrease adolescents ' amotivation for diabetes self-management .


ISRCTN 54243636 , registered on 10 January 2010 .


Life skills for adolescents with type 1 diabetes and their parents .


Two common general anaesthetic methods are total i.v. anaesthesia ( TIVA ) and inhalation anaesthesia , but it is unclear whether this affects the patient 's perception of their quality of recovery .


The Quality of Recovery-40 questionnaire ( QoR-40 ) is a valid and reliable method to evaluate the extent of functional recovery after surgery with general anaesthesia .


This study therefore compared patient recovery using the QoR-40 in surgical patients who received TIVA with those who received desflurane anaesthesia .


Eighty females ( 20-65 years old ) undergoing thyroid surgery were prospectively recruited and randomized to either the TIVA ( effect-site target controlled infusion using propofol and remifentanil ) or DES ( desflurane inhalation with manual infusion of remifentanil ) groups .


The QoR-40 was administered by an investigator blind to group allocation before surgery , and postoperative days 1 and 2 ( POD1 and POD2 ) .


Additional data including the incidence of nausea or vomiting , the consumption of antiemetic and analgesic agents in the post-anaesthesia care unit , and the duration of the hospital stay , were collected in all cases .


The QoR-40 score on POD1 was significantly higher in the TIVA group compared with the DES group ( 174 vs 161 , respectively ; P = 0.004 ) , indicating a better quality of recovery in the TIVA group .


Among the five dimensions of the QoR-40 , physical comfort and physical independence were significantly better on POD1 and POD2 in the TIVA group .


This study demonstrates that the quality of recovery for female thyroid surgery patients is significantly better with TIVA compared with desflurane anaesthesia .


www.clinicaltrials.org ; ref. : NCT01760018 .


To determine the value of cardiac MRI for the monitoring and the prognosis of patients with acute myocarditis .


Cardiac MRI plays an increasingly important role in the diagnosis of acute myocarditis .


However , it is less established as a prognostic tool , which requires specific postprocessing of images .


In a prospective pilot study , we assessed the prognostic value of the evolution in a simplified visual quantitative score ( SQS ) of late gadolinium enhancement ( LGE ) between initial hospitalization and 3 months later .


The prognostic value was assessed at 1 year using a combination of death , heart transplant , and confirmed recurrence as main outcome .


Twenty-eight patients were included in this study .


A significant correlation was found between LGE measured by SQS and planimetry ( r = 0.95 , P < 0.001 ) .


Intraobserver and interobserver reproducibilities were good for SQS ( ICC = 0.95 [ 95 % CI : 0.86 to 0.98 ] , and 0.94 [ 95 % CI : 0.84 to 0.98 ] , respectively ) .


At initial hospitalization , patient characteristics between the two groups were similar .


Patients with stable or increased SQS suffered more frequently from clinical outcome events than patients with a decrease in SQS ( P = 0.02 ) .


Monitoring of the evolution of LGE using a simple visual score is of interest to identify patients at risk of pejorative prognosis after acute myocarditis .


To evaluate maintenance of response while reducing intravenous abatacept dose from ~ 10 mg/kg to ~ 5 mg/kg in patients with early rheumatoid arthritis ( RA ) who achieved disease activity score ( DAS ) 28 ( erythrocyte sedimentation rate , ESR ) < 2.6 .


This 1-year , multinational , randomised , double-blind substudy evaluated the efficacy and safety of ~ 10 mg/kg and ~ 5 mg/kg abatacept in patients with early RA with poor prognosis who had reached DAS28 ( ESR ) < 2.6 at year 2 of the AGREE study .


The primary outcome was time to disease relapse ( defined as additional disease-modifying antirheumatic drugs , 2 courses high-dose steroids , return to open-label abatacept ~ 10 mg/kg , or DAS28 ( C reactive protein ) 3.2 at two consecutive visits ) .


108 patients were randomised ( ~ 10 mg/kg , n = 58 ; ~ 5 mg/kg , n = 50 ) .


Three and five patients , respectively , discontinued , and four per group returned to open-label abatacept .


Relapse over time and the proportion of patients relapsing were similar in both groups ( 31 % ( ~ 10 mg/kg ) vs 34 % ( ~ 5 mg/kg ) ; HR : 0.87 ( 95 % CI 0.45 to 1.69 ) ) .


Mean steady-state trough serum concentration for the ~ 10 mg/kg group was 20.3-24 .1 g/mL , compared with 8.8-12 .0 g/mL for the ~ 5 mg/kg group .


This exploratory study suggests that abatacept dose reduction may be an option in patients with poor prognosis early RA who achieve DAS28 ( ESR ) < 2.6 after 1 year on abatacept ( ~ 10 mg/kg ) .


NCT00989235 .


This study aimed to determine if delayed sodium ( 18 ) F-fluoride ( Na ( 18 ) F ) PET/CT imaging improves quantification of vascular calcification metabolism .


Blood-pool activity can disturb the arterial Na ( 18 ) F signal .


With time , blood-pool activity declines .


Therefore , delayed imaging can potentially improve quantification of vascular calcification metabolism .


Twenty healthy volunteers and 18 patients with chest pain were prospectively assessed by triple time-point PET/CT imaging at approximately 45 , 90 , and 180 minutes after Na ( 18 ) F administration .


For each time point , global uptake of Na ( 18 ) F was determined in the coronary arteries and thoracic aorta by calculating the blood-pool-corrected maximum standardized uptake value ( cSUV ( MAX ) ) .


A target-to-background ratio ( TBR ) was calculated to determine the contrast resolution at 45 , 90 , and 180 minutes .


Furthermore , we assessed whether the acquisition time-point affected the relation between cSUV ( MAX ) and the estimated 10-year risk for fatal cardiovascular disease ( SCORE % ) .


Coronary cSUV ( MAX ) ( P = .533 ) and aortic cSUV ( MAX ) ( P = .654 ) remained similar with time , whereas the coronary TBR ( P < .0001 ) and aortic TBR ( P < .0001 ) significantly increased with time .


Even though the contrast resolution improved with time , positive correlations between SCORE % and coronary cSUV ( MAX ) ( P < .020 ) and aortic cSUV ( MAX ) ( P < .005 ) were observed at all investigated time points .


Delayed Na ( 18 ) F PET/CT imaging does not improve quantification of vascular calcification metabolism .


Although contrast resolution improves with time , arterial Na ( 18 ) F avidity is invariant to the time between Na ( 18 ) F administration and PET/CT acquisition .


Therefore , the optimal PET/CT acquisition time-point to quantify vascular calcification metabolism is achieved as early as 45 minutes after Na ( 18 ) F administration .


To investigate the injection frequency and visual acuity ( VA ) outcomes with combination therapy ( ranibizumab plus verteporfin photodynamic therapy , PDT ) versus monotherapy ( ranibizumab ) .


A total of 40 patients with exudative age-related macular degeneration were randomized 1:1 to ranibizumab 0.3 mg plus single standard verteporfin PDT or ranibizumab 0.3 mg plus sham PDT .


Ranibizumab was administered 3 times monthly followed by ` as needed ' to month 12 based on predetermined vision/anatomical criteria .


Retreatment rates , VA outcomes and safety were assessed .


During months 3-12 , combination therapy patients required fewer ranibizumab injections ( mean 1.3 ) compared with monotherapy patients ( 2.8 ) .


Mean VA improved by 9.0 letters with combination therapy versus 7.5 letters in the monotherapy group at month 12 .


Both treatment regimens were well tolerated .


The need for ranibizumab retreatment might be reduced by administering a single verteporfin PDT on the same day as the first ranibizumab injection , without compromising VA outcomes or safety .


Anthrax vaccine adsorbed ( AVA ) administered intramuscularly ( IM ) results in fewer adverse events ( AEs ) than subcutaneous ( SQ ) administration .


Women experience more AEs than men .


Antibody response , female hormones , race , and body mass index ( BMI ) may contribute to increased frequency of reported injection site AEs .


We analyzed data from the CDC AVA human clinical trial .


This double blind , randomized , placebo controlled trial enrolled 1563 participants and followed them through 8 injections ( AVA or placebo ) over a period of 42 months .


For the trial 's vaccinated cohort ( n = 1267 ) , we used multivariable logistic regression to model the effects of study group ( SQ or IM ) , sex , race , study site , BMI , age , and post-vaccination serum anti-PA IgG on occurrence of AEs of any severity grade .


Also , in a women-only subset ( n = 227 ) , we assessed effect of pre-vaccination serum progesterone level and menstrual phase on AEs .


Participants who received SQ injections had significantly higher proportions of itching , redness , swelling , tenderness and warmth compared to the IM study group after adjusting for other risk factors .


The proportions of redness , swelling , tenderness and warmth were all significantly lower in blacks vs. non-black participants .


We found arm motion limitation , itching , pain , swelling and tenderness were more likely to occur in participants with the highest anti-PA IgG concentrations .


In the SQ study group , redness and swelling were more common for obese participants compared to participants who were not overweight .


Females had significantly higher proportions of all AEs compared to males .


Menstrual phase was not associated with any AEs .


Female and non-black participants had a higher proportion of AVA associated AEs and higher anti-PA IgG concentrations .


Antibody responses to other vaccines may also vary by sex and race .


Further studies may provide better understanding for higher proportions of AEs in women and non-black participants .


To compare the efficacy and safety of a new low-dose oral contraceptive pill ( YAZ ) containing drospirenone 3 mg and ethinylestradiol 20 g with placebo in reducing symptoms of premenstrual dysphoric disorder ( PMDD ) .


This multicenter , double - blind , randomized clinical trial consisted of 2 run - in and 3 treatment cycles ( 84 days ) with daily symptom charting ; 187 women with symptoms of PMDD were randomized to either placebo group ( n = 94 ) or YAZ group ( n = 93 ) , and assessed with daily record of severity of problems scale ( DRSP ) and clinical global impressions scale ( CGI ) before , during and after the treatments .


Hormones were administered for 24 days , followed by 4 days of inactive pills .


Compared with baseline level of DRSP , both groups got improvement after treatment ; the YAZ group ( median -28.7 , range : -82.5 to 2.3 ) had greater improvement than that in the placebo group ( median -23.7 , range : -86.0 to 11.8 ) , while there was not significant difference ( P > 0.05 ) .


The main adverse effects of YAZ included intermenstrual bleeding [ 13 % ( 12/93 ) versus 3 % ( 3/94 ) ] , menorrhagia [ 9 % ( 8/93 ) versus 1 % ( 1/94 ) ] , nausea [ 5 % ( 5/93 ) versus 4 % ( 4/94 ) ] and skin rash [ 4 % ( 4/93 ) versus 2 % ( 2/94 ) ] .


YAZ could improve symptoms of PMDD better than placebo , while without statistic significance in this study .


The most common adverse effects are intermenstrual bleeding , menorrhagia , nausea and rash .


Complementary feeding recommendations ( CFRs ) with the use of locally available foods can be developed by using linear programming ( LP ) .


Although its potential has been shown for planning phases of food-based interventions , the effectiveness in the community setting has not been tested to our knowledge .


We aimed to assess effectiveness of promoting optimized CFRs for improving maternal knowledge , feeding practices , and child intakes of key problem nutrients ( calcium , iron , niacin , and zinc ) .


A community-intervention trial with a quasi-experimental design was conducted in East Lombok , West Nusa Tenggara Province , Indonesia , on children aged 9-16 mo at baseline .


A CFR group ( n = 240 ) was compared with a non-CFR group ( n = 215 ) .


The CFRs , which were developed using LP , were promoted in an intervention that included monthly cooking sessions and weekly home visits .


The mother 's nutrition knowledge and her child 's feeding practices and the child 's nutrient intakes were measured before and after the 6-mo intervention by using a structured interview , 24-h recall , and 1-wk food-frequency questionnaire .


The CFR intervention improved mothers ' knowledge and children 's feeding practices and improved children 's intakes of calcium , iron , and zinc .


At the end line , median ( IQR ) nutrient densities were significantly higher in the CFR group than in the non-CFR group for iron [ i.e. , 0.6 mg/100 kcal ( 0.4-0 .8 mg/100 kcal ) compared with 0.5 mg/100 kcal ( 0.4-0 .7 mg/100 kcal ) ] and niacin [ i.e. , 0.8 mg/100 kcal ( 0.5-1 .0 mg/100 kcal ) compared with 0.6 mg/100 kcal ( 0.4-0 .8 mg/100 kcal ) ] .


However , median nutrient densities for calcium , iron , niacin , and zinc in the CFR group ( 23 , 0.6 , 0.7 , and 0.5 mg/100 kcal , respectively ) were still below desired densities ( 63 , 1.0 , 0.9 , and 0.6 mg/100 kcal , respectively ) .


The CFRs significantly increased intakes of calcium , iron , niacin , and zinc , but nutrient densities were still below desired nutrient densities .


When the adoption of optimized CFRs is constrained by economic access for or acceptability of nutrient-dense foods , other strategies need to be incorporated into interventions to ensure adequate intakes of these nutrients .


The 1 year prevalence of depression in adolescents is about 2 % .


Treatment with antidepressant medication is not recommended for initial treatment in young people due to concerns over high side effects , poor efficacy and addictive potential .


Evidence suggests that cognitive behaviour therapy ( CBT ) is an effective treatment for depression and is currently one of the main treatment options recommended in adolescents .


Given the affinity young people have with information technology they may be treated effectively , more widely and earlier in their illness evolution using computer-administered CBT ( CCBT ) .


Currently little is known about the clinical and resource implications of implementing CCBT within the National Health Service for adolescents with low mood/depression .


We aim to establish the feasibility of running a fully powered randomised controlled trial ( RCT ) .


Adolescents aged 12-18 with low mood/depression , ( scoring 20 on the Mood and Feelings Questionnaire ( MFQ ) ) , will be approached to participate .


Consenting participants will be randomised to either a CCBT programme ( Stressbusters ) or accessing selected websites providing information about low mood/depression .


The primary outcome measure will be the Beck Depression Inventory ( BDI ) .


Participants will also complete generic health measures ( EQ5D-Y , HUI2 ) and resource use questionnaires to examine the feasibility of cost-effectiveness analysis .


Questionnaires will be completed at baseline , 4 and 12-month follow-ups .


Progress and risk will be monitored via the MFQ administered at each treatment session .


The acceptability of a CCBT programme to adolescents ; and the willingness of clinicians to recruit participants and of participants to be randomised , recruitment rates , attrition rates and questionnaire completion rates will be collected for feasibility analysis .


We will estimate ` numbers needed ' to plan a fully powered RCT of clinical and cost-effectiveness .


The current trial protocol received a favourable ethical opinion from Leeds ( West ) Research and Ethics Committee .


( Reference : 10/H1307/137 ) .


ISRCTN31219579 .


Assess longterm tolerability , safety , and efficacy of subcutaneous ( SC ) abatacept ( ABA ) in methotrexate-refractory patients with rheumatoid arthritis ( RA ) .


The phase III , multinational Abatacept Comparison of Sub [ QU ] cutaneous Versus Intravenous in Inadequate Responders to MethotrexatE ( ACQUIRE ) trial comprised a 6-month , randomized , double-blind ( DB ) period , in which patients received intravenous ( IV ) or SC ABA , plus MTX , followed by an open-label , longterm extension ( LTE ) , in which patients received SC ABA , 125 mg/week .


Safety and efficacy from the LTE ( 3.5 yrs of exposure ) are reported .


Patients who completed the DB period ( 1372/1385 , 99.1 % ) entered the LTE ; 1134 patients ( 82.7 % ) kept taking the treatment at time of reporting .


Mean ( SD ) was 31.9 months ( 6.8 ) ; median ( range ) exposure was 33.0 ( 8-44 ) months .


Patients entering the LTE had longstanding , moderate-to-severe disease [ mean 7.6 ( 7.9 ) yrs and DAS28 ( C-reactive protein ) 6.2 ( 0.9 ) ] .


Incidence rates ( events/100 patient-yrs ) were reported for serious adverse events ( 8.76 , 95 % CI 7.71 , 9.95 ) , infections ( 44.80 , 95 % CI 41.76 , 48.01 ) , serious infections ( 1.72 , 95 % CI 1.30 , 2.27 ) , malignancies ( 1.19 , 95 % CI 0.86 , 1.66 ) , and autoimmune events ( 1.31 , 95 % CI 0.95 , 1.79 ) .


Twenty-seven patients ( 2 % ) experienced injection-site reactions ; all except 1 were mild .


American College of Rheumatology 20 , 50 , and 70 responses achieved during the DB period were maintained through the LTE , and on Day 981 were 80.2 % ( 95 % CI 77.2 , 83.2 ) , 63.5 % ( 95 % CI 58.2 , 68.9 ) , and 39.5 % ( 95 % CI 34.0 , 44.9 ) for patients who kept taking SC ABA , and 80.0 % ( 95 % CI 77.0 , 83.0 ) , 63.2 % ( 95 % CI 57.8 , 68.7 ) , and 39.2 % ( 95 % CI 33.7 , 44.7 ) for those who switched from IV to SC ABA .


These findings support SC ABA as a well-tolerated and efficacious longterm treatment for patients with RA and inadequate response to MTX ( ClinicalTrials.gov identifier NCT00559585 ) .


Alvimopan is indicated to accelerate the time to gastrointestinal recovery following partial bowel resection with primary anastomosis .


The approved dosing regimen includes an initial dose prior to surgery and 12 mg twice daily after surgery for up to 7 days ; however , there are no human studies evaluating the need for the preoperative dose .


We report our experience with gastrointestinal recovery when the preoperative dose is omitted .


To evaluate the efficacy of alvimopan therapy when the preoperative dose is not administered .


This retrospective study included elective surgery patients who underwent bowel resection with primary anastomosis without colostomy or ileostomy .


The study compared ( a ) patients who received alvimopan and received a dose preoperatively , ( b ) patients who received alvimopan but did not receive a dose preoperatively , and ( c ) matched control patients who did not receive alvimopan .


Length of stay following bowel resection , direct hospital costs , time to first bowel movement , and time to oral diet were evaluated .


Of 50 patients who received alvimopan , 27 received the preoperative dose and 23 did not .


These 50 patients were matched to similar control patients who received no alvimopan during their admission for resection .


Compared with controls , time to discharge was significantly shorter in patients who received alvimopan , regardless of whether the preoperative dose was administered ( P < .001 ) or omitted ( P = .03 ) .


Patients who did not receive the preoperative dose still experienced faster time to first bowel movement ( 71 vs 97 hours ; P = .006 ) and faster time to first diet ( 17 vs 54 hours ; P < .001 ) than non-alvimopan users .


Patients receiving the approved alvimopan dosing regimen experienced the most rapid recovery of gastrointestinal function .


However , administering alvimopan only postoperatively ( if the preoperative dose is omitted ) may still reduce the severity of postoperative ileus .


Retrospective studies have shown that a significant number of ovarian borderline tumors , ovarian metastases , and nonepithelial tumors were erroneously diagnosed as ovarian carcinomas .


This may lead to unnecessary morbidity , suboptimal therapeutic modalities , and unintended bias in clinical trials .


The aim of this study was to investigate the frequency and clinical significance of such diagnostic discrepancies .


Original histological slides from patients with ovarian carcinomas included in phase III chemotherapy trials of the Working Group on Gynecological Oncology ( AGO ) were reviewed by at least two specialized pathologists .


Diagnostic discrepancies were classified as being either clinically relevant ( major ) or clinically not relevant ( minor ) .


A total of 454 out of 533 patients from the AGO OVAR11 ( ICON7 ) trial gave consent to the second opinion on the pathology results .


All of the 104 institutes of pathology responsible for the original diagnoses contributed to the study .


The first diagnosis and the second opinion pathology review were identical in 295 out of 454 ( 65 % ) cases .


In 128 cases ( 28.2 % ) a minor discrepancy was found and 31 cases ( 6.8 % ) were shown to have a major discrepancy .


The assumption of a significant number or erroneous diagnoses in chemotherapy trials of ovarian carcinomas was confirmed .


A pathology review seems therefore desirable and may help to reduce unnecessary morbidity and optimize therapeutic strategies .


Moreover , improvement of quality in therapy trials may become possible .


In another study a new concept allowing a rapid pathology review before randomization of patients has now been successfully tested and it may well have potential to form the basis for modern networking consultation pathology .


To compare procedure times and complication rates of preincisional ultrasonographic ( US ) evaluation and perioperative US guidance in percutaneous dilatational tracheostomy ( PDT percutaneous dilatational tracheostomy ) with those of the current standard of care , PDT percutaneous dilatational tracheostomy performed without image guidance .


Between December 2007 and January 2011 , 341 patients were included in this institutional review board-approved study after informed consent was obtained from the patients or their relatives .


The patients were divided randomly into two groups .


In group A ( n = 166 ) , the possible causes of complications , such as aberrations of tracheal , thyroidal , and vascular structures , were determined with US , and tracheal measurements were performed by using US .


The clinician 's initial considerations at physical examination were compared with the US findings .


PDT percutaneous dilatational tracheostomy was subsequently performed with US guidance in suitable cases .


In group B ( n = 175 ) , PDT percutaneous dilatational tracheostomy was performed solely on the basis of physical landmarks .


The procedure times and complication rates were compared across groups by using the Fisher exact test .


In group A , the puncture sites designated at the physical examination were reconsidered in 39 ( 23.8 % ) of 164 cases .


The perioperative complication rates were slightly lower in group A ( 7.8 % [ 12 of 154 ] ) than in group B ( 15.0 % [ 25 of 167 ] ) ; however , the difference did not achieve statistical significance ( P = .054 ) .


The mean procedure times for groups A and B were 24.09 minutes 8.05 ( standard deviation ) ( range , 14-68 minutes ) and 18.62 minutes 6.34 ( range , 12-81 minutes ) , respectively ( P = .001 ) , and the numbers of patients in each group who required multiple puncture attempts were six ( 3.9 % ) of 154 and 23 ( 13.6 % ) of 169 ( P = .003 ) , respectively .


The use of US guidance before and during PDT percutaneous dilatational tracheostomy could render the procedure easier and safer , with fewer complications but a slightly longer procedure time .


To assess erectile function in middle-aged and older men with asexuality status and further analyze their specific reasons for this condition .


Men who had regular sexual intercourse attempts ( sex frequency 1 time per month ) were classified into mild erectile dysfunction ( ED ) , moderate to severe ED and non-ED according to International Index of Erectile Function-5 , and men having no sexual intercourse attempts for at least 6 months were defined as having an asexuality status .


The risk factors associated with ED were collected in a sample of 1,531 Chinese men aged 40 to 80 years , and the self-report reasons for asexuality were recorded in asexual cohort individually .


Comparative analyses and multivariate regression models were conducted among these groups .


The prevalence rates of ED and asexuality status were 49.9 % and 37.2 % .


The asexuality status group had higher risk factors than the moderate to severe ED group in terms of old age ( age 65 , adjusted odds ratio ( OR ) 17.69 versus ( Vs. ) 7.19 ) , diabetes ( crude OR : 2.40 Vs. 2.36 ) and hypertension ( crude OR : 1.78 Vs. 1.72 ) .


The specific reasons for the asexuality status were `` erectile difficulty '' ( 52.9 % ) , `` do not care about sexuality '' ( 53.5 % ) '' , `` no longer necessary to have sexuality at this age '' ( 47.7 % ) , `` severe stress '' ( 44.4 % ) , `` severe fatigue '' ( 26.3 % ) and `` masturbation '' ( 26.9 % ) .


Men with an asexual status suffer from higher risk factors for ED than men with moderate to severe ED .


The majority of this asexual status could be attributed to a full ED , although the reasons for this transient asexuality also involved sexual attitudes and interests , sexual partners and masturbation .


The aim of this study was to evaluate the Eye Retinopathy Trainer as a teaching tool for direct ophthalmoscopy examination by comparing it with the traditional method using volunteers .


Fourth year medical students received training in direct ophthalmoscopy using a simulation tool and human volunteers .


Ninety students were randomized into a Simulation Group or a Control Group by the inclusion or absence of the simulation model in classroom practice .


Differences between the groups were analyzed using unpaired Student 's t-test .


The Simulation Group was superior to the Control Group , with 51.06 % successful in performing fundus examination in both the anatomical model simulation and the human model in comparison with 21.15 % in the Control Group .


The Eye Retinopathy Trainer appears to be an effective teaching tool for practice and improvement of ophthalmologic examination among fourth year medical students .


PT302 is a sustained-release exenatide under clinical development for the treatment of type 2 diabetes mellitus .


The aim of this study was to evaluate the pharmacokinetic properties , pharmacodynamic properties , and tolerability of PT302 after a single subcutaneous injection in healthy individuals .


A dose-block randomized , double-blind , placebo-controlled , dose-escalating study ( 0.5 , 1 , 2 , and 4 mg ) was performed in 34 healthy individuals .


The plasma concentrations of exenatide in serial blood samples were quantified for 56 days after dosing with an exendin-4 fluorescent immunoassay kit .


Noncompartmental analysis was performed to assess the pharmacokinetic characteristics of PT302 .


Oral glucose tolerance tests were repeated weekly until day 42 ; the concentrations of serum glucose , serum C-peptide , plasma insulin , and plasma glucagon were measured for 2 hours to evaluate the pharmacodynamic characteristics of PT302 .


Clinical laboratory tests , vital signs , physical examinations , 12-lead ECGs , and adverse events were monitored to evaluate the safety profile and tolerability .


PT302 exhibits a biphasic pharmacokinetic profile , with the initial peak occurring 2 hours after administration .


PT302 was quantifiable in the plasma until days 23 , 30 , 32 , and 55 ( median ) in the 0.5-mg , 1-mg , 2-mg , and 4-mg dosage groups of PT302 , respectively .


Systemic exposure increased proportionally to the dose during the entire dose range investigated .