MRI erosion scores at weeks 12 and 52 correlated strongly with radiography erosion scores at week 52 ( r > 0.80 ) .


Baseline synovitis and worsening of osteitis predicted erosion progression .


Rapid suppression of synovitis and osteitis with reduction in structural joint damage progression occurred with TCZ , as monotherapy or in combination with MTX , through week 52 .


Recent posttrial analysis of a completed randomized trial found an increased risk of prostate cancer among healthy men taking high-dose vitamin E supplements .


Trials that examined the effect of vitamin C supplements on cancer risk are few .


We examined whether vitamin E or vitamin C supplementation affects the risk of cancer events during posttrial follow-up of the Physicians ' Health Study II .


Beginning in 1997 , a total of 14,641 US male physicians aged 50 y were randomly assigned to receive 400 IU of vitamin E every other day , 500 mg of vitamin C daily , or their respective placebos .


The vitamin E and vitamin C treatment ended in 2007 , and observational follow-up continued through June 2011 .


This study included an additional 356 cases of incident prostate cancer and 771 total cancers that developed during a mean ( maximum ) of 2.8 ( 3.8 ) y of posttrial observation .


During an overall mean of 10.3 ( 13.8 ) y , there were a total of 1373 incident prostate cancers and 2669 total cancers documented .


In comparison with placebo , vitamin E supplementation had no effect on the incidence of prostate cancer ( HR : 0.99 ; 95 % CI : 0.89 , 1.10 ) or total cancers ( HR : 1.02 ; 95 % CI : 0.95 , 1.10 ) .


There was also no effect of vitamin C supplementation on total cancers ( HR : 1.02 ; 95 % CI : 0.94 , 1.10 ) or incident prostate cancer ( HR : 1.03 ; 95 % CI : 0.93 , 1.15 ) .


Neither vitamin E nor vitamin C supplementation had effects on other site-specific cancers overall .


Stratification by known cancer risk factors , history of cancer , other randomized treatment , and follow-up time showed no significant interactions .


In this large-scale randomized trial in men , vitamin E and C supplementation had no immediate or long-term effects on the risk of total cancers , prostate cancer , or other site-specific cancers .


Although millions of aesthetic procedures are performed annually , few patient-reported outcome ( PRO ) measures have been used in this setting .


To evaluate the impact of onabotulinumtoxinA treatment for crow 's feet lines ( CFL ) on relevant psychological variables and self-perception of age/appearance in subgroup populations .


Facial Lines Outcomes ( FLO-11 ) Questionnaire , Self-Perception of Age ( SPA ) , and Subject Global Assessment of Change in CFL ( SGA-CFL ) were PRO measures administered in 2 Phase 3 , double-blind placebo-controlled trials for the treatment of CFL alone or CFL/glabellar lines ( GL ) .


Patient-reported outcome measures were analyzed by subgroups ( age , gender , and baseline CFL severity ) .


Subject satisfaction with appearance was also analyzed .


Most subgroups receiving onabotulinumtoxinA demonstrated significant improvements in psychological impact ( FLO-11 Items 2 , 5 , and 8 ) versus placebo at Day 30 ( p .05 ) .


OnabotulinumtoxinA-treated subjects consistently rated themselves as looking younger on SPA versus placebo in all subgroups at Day 30 ( p .05 ) and showed significant improvements in CFL appearance versus placebo at all time points on SGA-CFL .


Overall , subjects were satisfied with their appearance .


OnabotulinumtoxinA-treated subjects experienced significant improvements in perceived appearance , attractiveness , tiredness , age , and satisfaction versus placebo .


Subjects treated for CFL and GL experienced even greater effects .


Retrospective single institution data suggest that postoperative pain after robot-assisted laparoscopic radical prostatectomy is decreased by early removal of the urethral catheter with suprapubic tube drainage .


In a randomized patient population we determined whether suprapubic tube drainage with early urethral catheter removal would improve postoperative pain compared with urethral catheter drainage alone .


Men with a body mass index of less than 40 kg/m ( 2 ) who had newly diagnosed prostate cancer and elected robot-assisted laparoscopic radical prostatectomy were included in analysis .


Block randomization by surgeon was used and randomization assignment was done after completing the urethrovesical anastomosis .


In patients assigned to suprapubic tube drainage the urethral catheter was removed on postoperative day 1 and all catheters were removed on postoperative day 7 .


Visual analog pain scale and satisfaction questionnaires were administered on postoperative days 0 , 1 and 7 .


A total of 29 patients were randomized to the urethral catheter vs 29 to the suprapubic tube plus early urethral catheter removal at the time of interim futility analysis .


Mean visual analog pain scale scores did not differ between the groups at any time point and a similar percent of patients cited the catheter as the greatest bother with nonsignificant differences in treatment related satisfaction .


Complications during postoperative week 1 did not vary between the groups .


Based on interim results the trial was terminated due to lack of effect .


Patients randomized to suprapubic tube vs urethral catheter drainage for the week after prostatectomy had similar pain , catheter related bother and treatment related satisfaction in the perioperative period .


We no longer routinely offer suprapubic tube drainage with early urethral catheter removal at our institution .


To investigate the clinical effect of combination therapy with high-frequency oscillation ventilation ( HFOV ) , pulmonary surfactant ( PS ) and inhaled nitric oxide ( iNO ) in the treatment of neonatal hypoxemic respiratory failure ( HRF ) .


A total of 116 neonates with HRF were studied , and they were randomly divided into two groups : triple therapy ( n = 58 ) and dual therapy ( n = 58 ) .


The triple therapy group received HFOV , PS , and iNO , while the dual therapy group received HFOV and iNO .


Blood gas values , PaO2/FiO2 ( P/F ) , oxygenation index ( OI ) , and pulmonary arterial pressure ( PA ) were determined before treatment and after 24 and 48 hours of treatment .


Among the neonates with different P/F ratios and OI values and with or without persistent pulmonary hypertension of the newborn ( PPHN ) , the treatment outcomes of two groups were compared .


The durations of mechanical ventilation and iNO therapy in the triple therapy group were significantly shorter than in the dual therapy group ( P < 0.01 ) .


After 24 and 48 hours of treatment , the triple therapy group had significantly improve PaO2 and PaCO2 compared with the dual therapy group ( P < 0.01 ) .


After 24 and 48 hours of treatment , the neonates with PPHN in the triple therapy group had significantly decreased PA compared with the dual therapy group ( P < 0.01 ) .


In the cases with a P/F ratio of 50 , the triple group had a significantly higher cure rate than the dual therapy group ( P < 0.05 ) .


In both groups , the P/F ratios of the neonates who died were significantly lower than those of survivors ( P < 0.01 ) .


In the cases with an OI of 40 , the triple group had a significantly higher cure rate than the dual therapy group ( P < 0.05 ) .


In both groups , the OI values of the neonates who died were significantly higher than those of survivors ( P < 0.01 ) .


In neonates with PPHN , the triple group had a significantly higher cure rate than the dual therapy group ( P < 0.05 ) .


The triple therapy group had a significantly shorter length of hospital stay ( P < 0.01 ) and a significantly higher cure rate ( P < 0.05 ) compared with the dual therapy group .


There were no significant differences in complications between the two groups ( P > 0.05 ) .


No severe side effect was found during the treatment in either group .


Triple therapy with HFOV , PS and iNO is a more effective treatment for neonatal HRF compared with the dual therapy with HFOV and iNO .


The triple therapy can significantly improve oxygenation and survival rate , providing a new treatment for the neonates with HRF , especially the critical cases who suffer severe lung disease with PPHN and have a P/F ratio of 50 or an OI of 40 .


Several neuroscience tools showed the involvement of auditory cortex in chronic tinnitus .


In this proof-of-principle study we probed the capability of functional near-infrared spectroscopy ( fNIRS ) for the measurement of brain oxygenation in auditory cortex in dependence from chronic tinnitus and from intervention with transcranial magnetic stimulation .


Twenty-three patients received continuous theta burst stimulation over the left primary auditory cortex in a randomized sham-controlled neuronavigated trial ( verum = 12 ; placebo = 11 ) .


Before and after treatment , sound-evoked brain oxygenation in temporal areas was measured with fNIRS .


Brain oxygenation was measured once in healthy controls ( n = 12 ) .


Sound-evoked activity in right temporal areas was increased in the patients in contrast to healthy controls .


Left-sided temporal activity under the stimulated area changed over the course of the trial ; high baseline oxygenation was reduced and vice versa .


By demonstrating that rTMS interacts with auditory evoked brain activity , our results confirm earlier electrophysiological findings and indicate the sensitivity of fNIRS for detecting rTMS induced changes in brain activity .


Moreover , our findings of trait - and state-related oxygenation changes indicate the potential of fNIRS for the investigation of tinnitus pathophysiology and treatment response .


To evaluate the effect of combination of ranibizumab and laser photocoagulation to peripheral retinal areas of nonperfusion in patients with non-ischemic central retinal vein occlusion ( CRVO ) without neovascularizations .


This prospective , proof of concept study randomized 22 CRVO patients into two arms .


The RL group ( ranibizumab + laser ; n = 10 ) received ranibizumab with additive laser photocoagulation ; the control R group ( n = 12 ) was treated with ranibizumab only .


All patients received three initial monthly ranibizumab injections followed by PRN regimen .


Changes in best corrected visual acuity ( BCVA ) and in central retinal thickness ( CRT ) were documented over 6 months .


Median of BCVA improved in the RL group from 65 ETDRS letters ( interquartile range IQR = 10 letters ) at baseline to 70 ( IQR = 23.2 ) letters at month 6 .


In the control group BCVA remained stable [ baseline : 61 ( IQR = 19.5 ) and month 6 : 61 ( IQR = 22 ) letters ] .


CRT decreased between baseline and final visit in the RL group from 547 ( IQR = 513 ) m to 246.5 ( IQR = 346.3 ) m , and in the control group from 637.5 ( IQR = 344 ) m to 423 ( IQR = 737 ) m.


More pronounced improvements in BCVA were seen in the RL group ( medians = 14 vs. 6.5 letters ) although the observed group differences were not statistically significant due to small samples .


The selective laser photocoagulation of peripheral areas of nonperfusion seems to lead to additional visual improvement in patients with CRVO .


A larger replication trial is necessary to confirm the results of this proof of concept study .


To evaluate the effectiveness of a coparenting intervention on exclusive breastfeeding among primiparous mothers and fathers .


A randomized controlled trial was conducted in a large teaching hospital in Toronto , Canada .


Couples were randomized to receive either usual care ( n = 107 ) or a coparenting breastfeeding support intervention ( n = 107 ) .


Follow-up of exclusive breastfeeding and diverse secondary outcomes was conducted at 6 and 12 weeks postpartum .


Significantly more mothers in the intervention group than in the control group continued to breastfeed at 12 weeks postpartum ( 96.2 % vs 87.6 % , P = .02 ) .


Although proportionately more mothers in the intervention group were exclusively breastfeeding at 6 and 12 weeks , these differences were not significant .


Fathers in the intervention group had a significantly greater increase in breastfeeding self-efficacy scores from baseline to 6 weeks postpartum compared with fathers in the control group ( P = .03 ) .


In addition , significantly more mothers in the intervention group than in the control group reported that their partners provided them with breastfeeding help in the first 6 weeks ( 71 % vs 52 % , P = .02 ) and that they were satisfied with their partners ' involvement with breastfeeding ( 89 % vs 78.1 % , P = .04 ) .


Mothers in the intervention group were also more satisfied with the breastfeeding information they received ( 81 % vs 62.5 % , P < .001 ) .


The significant improvements in breastfeeding duration , paternal breastfeeding self-efficacy , and maternal perceptions of paternal involvement and assistance with breastfeeding suggest that a coparenting intervention involving fathers warrants additional investigation .


To examine the effect of rilonacept on the health-related quality of life ( HRQoL ) in patients with poorly controlled familial Mediterranean fever ( FMF ) .


As part of a randomized , double-blinded trial comparing rilonacept and placebo for the treatment of FMF , patients/parents completed the modified Child Health Questionnaire ( CHQ ) at baseline , and at the start and end of each of 4 treatment courses , 2 each with rilonacept and placebo .


Fourteen subjects were randomized ; mean age was 24.4 11.8 years .


At baseline the physical HRQoL score was significantly less ( 24.2 49.5 ) but the psychosocial score was similar to the population norm ( 49.5 10.0 ) .


There were significant improvements in most HRQoL concepts after rilonacept but not placebo .


Significant differences between rilonacept and placebo were found in the physical ( 33.7 16.4 versus 23.7 14.5 , P = 0.021 ) but not psychosocial scores ( 51.4 10.3 versus 49.8 12.4 , P = 0.42 ) .


The physical HRQoL was significantly impacted by the treatment effect and patient global assessment .


Treatment with rilonacept had a beneficial effect on the physical HRQoL in patients with poorly controlled FMF and was also significantly related to the patient global assessment .


This trial is registered with ClinicalTrials.gov Identifier NCT00582907 .


An elevated resting heart rate ( RHR ) may be an early sign of cardiac failure , but its prognostic value during watchful waiting in asymptomatic aortic stenosis ( AS ) is largely unknown .


RHR was determined by annual ECGs in the Simvastatin and Ezetimibe in Aortic Stenosis ( SEAS ) study of asymptomatic mild-to-moderate AS patients .


Primary endpoint in this substudy was major cardiovascular events ( MCEs ) and secondary outcomes its individual components .


Multivariable Cox-models using serially-measured RHR were used to examine the prognostic impact of RHR per se .


1563 patients were followed for a mean of 4.3 years ( 6751 patient-years of follow-up ) , 553 ( 35 % ) MCEs occurred , 10 % ( n = 151 ) died , including 75 cardiovascular deaths .


In multivariable analysis , baseline RHR was independently associated with MCEs ( HR 1.1 per 10min ( -1 ) faster , 95 % CI : 1.0-1 .3 ) and cardiovascular mortality ( HR 1.3 per 10min ( -1 ) faster , 95 % CI : 1.0-1 .7 , both p0 .03 ) .


Updating RHR with annual in-study reexaminations , time-varying RHR was highly associated with excess MCEs ( HR 1.1 per 10min ( -1 ) faster , 95 % CI : 1.1-1 .3 ) and cardiovascular mortality ( HR 1.4 per 10min ( -1 ) faster , 95 % CI : 1.2-1 .7 , both p0 .006 ) .


The association of RHR with MCEs and cardiovascular mortality was not dependent on atrial fibrillation status ( both p0 .06 for interaction ) .


RHR is independently associated with MCEs and cardiovascular death in asymptomatic AS ( Clinicaltrials.gov ; unique identifier NCT00092677 ) .


The aim of the present study was to evaluate the efficacy and safety of narrowband UVB ( NB-UVB ) compared with tacrolimus ointment 0.1 % in patients with bilateral vitiligo .


In this comparative study , four groups of patients were randomized .


Each group was composed by 12 patients with bilateral vitiligo ; in each group , every patient was irradiated with NB-UVB ( length : 311 nm ) twice a week for 9 months and applied tacrolimus ointment 0.1 % twice a day on the other area in the same period .


Before starting therapy and after 3 , 6 and 9 months of therapy , a clinical and photographic evaluation of percentage of repigmentation was performed and Dermatology Life Quality Index Questionnaire was fulfilled .


A repigmentation at least partial occurred in 71 % of patients after 36 weeks of treatment with tacrolimus ointment 0.1 % ; in the whole sample , 14 patients ( 29 % ) showed no repigmentation at all , with 2 of them discontinuing the therapy because of side effects ( erythema and folliculitis-like manifestations ) .


A homogeneous repigmentation at least partial occurred in 69 % of patients after 36 weeks of treatment with NB-UVB ; in the whole sample 15 patients ( 31 % ) showed no repigmentation at all , with 1 of them discontinuing the therapy because of side effects .


The present study confirmed that the efficacy of NB-UVB phototherapy in vitiligo is comparable to tacrolimus ointment 0.1 % therapy .


On the basis of our study , we may suggest tacrolimus ointment 0.1 % as an alternative to NB-UVB therapy for treating vitiligo .


In order to quantify the effects of physical activity such as walking on chronic disease , accurate measurement of physical activity is needed .


The objective of this study was to determine the validity and reliability of a new activity monitor , the Fitbit One , in a population of healthy adults .


Cross-sectional study .


Thirty healthy adults ambulated at 5 different speeds ( 0.90 , 1.12 , 1.33 , 1.54 , 1.78 m/s ) on a treadmill while wearing three Fitbit One activity monitors ( two on the hips and one in the pocket ) .


The order of each speed condition was randomized .


Fitbit One step count output was compared to observer counts and distance output was compared to the calibrated treadmill output .


Two-way repeated measures ANOVA , concordance correlation coefficients , and Bland and Altman plots were used to assess validity and intra-class correlation coefficients ( ICC ) were used to assess reliability .


No significant differences were noted between Fitbit One step count outputs and observer counts , and concordance was substantial ( 0.97-1 .00 ) .


Inter-device reliability of the step count was high for all walking speeds ( ICC 0.95 ) .


Percent relative error was less than 1.3 % .


The distance output of the Fitbit One activity monitors was significantly different from the criterion values for each monitor at all speeds ( P < 0.001 ) and exhibited poor concordance ( 0.0-0 .05 ) .


Inter-device reliability was excellent for all treadmill speeds ( ICC 0.90 ) .


Percent relative error was high ( up to 39.6 % ) .


The Fitbit One activity monitors are valid and reliable devices for measuring step counts in healthy young adults .


The distance output of the monitors is inaccurate and should be noted with caution .


Delayed-release dimethyl fumarate ( DMF , also known as gastro-resistant DMF ) , demonstrated efficacy and safety in relapsing-remitting multiple sclerosis in the 2-year , randomized , placebo-controlled , phase 3 DEFINE and CONFIRM trials .


A post hoc analysis of integrated data from DEFINE and CONFIRM was conducted to determine the temporal profile of the clinical and neuroradiological effects of DMF .


Eligible patients were randomized to receive placebo , DMF 240mg twice ( BID ) or three times ( TID ) daily or glatiramer acetate ( GA ; reference comparator ; CONFIRM only ) for up to 96weeks .


Patients in the GA group were excluded from this analysis .


A total of 2301 patients were randomized and received treatment with placebo ( n = 771 ) or DMF BID ( n = 769 ) or TID ( n = 761 ) .


DMF significantly reduced the annualized relapse rate beginning in weeks 0-12 ( BID , P = 0.0159 ; TID , P = 0.0314 ) ; the proportion of patients relapsed beginning at week 10 ( BID , P = 0.0427 ) and week 12 ( TID , P = 0.0451 ) ; and the proportion of patients with 12-week confirmed disability progression beginning at week 62 ( BID , P = 0.0454 ) and week 72 ( TID , P = 0.0399 ) , compared with placebo .


These effects were sustained throughout the 2-year study period .


DMF significantly reduced the odds of having a higher number of gadolinium-enhancing lesions by 88 % ( BID ) and 75 % ( TID ) and the mean number of new or enlarging T2 lesions by 72 % ( BID ) and 67 % ( TID ) , from the first post-baseline magnetic resonance imaging assessment at 24weeks ( all P < 0.0001 versus placebo ) .


In phase 3 clinical trials , DMF demonstrated rapid and sustained clinical and neuroradiological efficacy in relapsing-remitting multiple sclerosis .


Repetitive transcranial magnetic stimulation ( rTMS ) is able to induce changes in neuronal activity that outlast stimulation .


The underlying mechanisms are not completely understood .


They might be analogous to long-term potentiation or depression , as the duration of the effects seems to implicate changes in synaptic plasticity .


Norepinephrine ( NE ) has been shown to play a crucial role in neuronal plasticity in the healthy and injured human brain .


Atomoxetine ( ATX ) and other NE reuptake inhibitors have been shown to increase excitability in different systems and to influence learning processes .


Thus , the combination of two facilitative interventions may lead to further increase in excitability and motor learning .


But in some cases homeostatic metaplasticity might protect the brain from harmful hyperexcitability .


In this study , the combination of 60mg ATX and 10Hz rTMS over the primary motor cortex was used to examine changes in cortical excitability and motor learning and to investigate their influence on synaptic plasticity mechanisms .


The results of this double-blind placebo-controlled study showed that ATX facilitated corticospinal and intracortical excitability in motor cortex .


10 Hertz rTMS applied during a motor task was able to further increase intracortical excitability only in combination with ATX .


In addition , only the combination of 10Hz rTMS and ATX was capable of enhancing the total number of correct responses and reaction time significantly , indicating an interaction effect between rTMS and ATX without signs of homeostatic metaplasticity .


These results suggest that pharmacologically enhanced NE transmission and 10Hz rTMS exert a synergistic effect on motor cortex excitability and motor learning in healthy humans .


To investigate whether self care behaviours , medical outcomes and quality of life of Taiwanese elderly with Type 2 diabetes mellitus ( DM ) can be improved by delivery of an educational health care package .


DM is a major health problem in developed and developing countries , with older adults constituting about half of the diabetic population .


Type 2 DM is the most rapidly increasing chronic disease in Taiwan .


During 2005 and 2006 , Taiwanese elderly with Type 2 DM ( n = 500 ) were randomly allocated to either an intervention or control group .


Data collection using validated instruments occurred at baseline and 6 months follow-up .


Main outcome measures were blood glucose levels and diabetic complications .


At baseline , 88.4 % participants in the control and 78.8 % in the experimental group had a blood glucose level above normal range ( p = 0.076 ) ; respective results at 6 months were 92.4 % for the control group and 60.4 % for the experimental group ( p < 0.001 ) .


The multivariate adjusted result showed that the intervention group was 11.1 times less likely to have blood glucose levels above normal ( p = 0.002 ) at 6 months follow-up compared to the control group .


Occurrence of complications was significantly fewer in the intervention group at baseline and at 6 month follow-up compared to the control group ( baseline : 42.0 % versus 82.1 % , p = 0.003 ; 6 month follow-up : 48.4 % versus 87.0 % ; p = 0.006 ) .


Although overall occurrence of complications remained unchanged , the educational health care package specifically developed for Taiwanese elderly with Type 2 DM improved blood glucose levels .


Transnasal esophagogastroduodenoscopy ( EGD ) without sedation has been reported to be safe and tolerable .


It has recently been used widely in Japan for the detection of upper gastrointestinal disease .


Alternatively , transoral examination using a thin endoscope has also been reported to be highly tolerable .


To examine the cardiocirculatory effects of transoral versus transnasal EGD in an attempt to determine the most suitable endoscopic methods for patients 75 years of age .


Subjects who underwent monitoring of respiratory and circulatory dynamics without sedation during endoscopic screening examinations were enrolled at the New Ooe Hospital ( Kyoto , Japan ) between April 2008 and March 2009 .


A total of 165 patients ( age 75 years ) provided written informed consent and were investigated in the present study .


Patients were randomly divided into three subgroups : UO group -- thin endoscope ; SO group -- standard endoscope ; and UT group -- transnasal EGD .


Percutaneous arterial blood oxygen saturation , heart rate and blood pressure were evaluated just before EGD and at five time points during EGD .


After transnasal EGD , patients who had previously been examined using transoral EGD with a standard endoscope were asked about preferences for their next examination .


There were no statistical differences in the characteristics among the groups .


Percutaneous oxygen saturation in the UT group showed a transient drop compared with the SO and UO groups at the beginning of the endoscopic procedure .


Heart rate showed no significant differences among the SO , UO and UT groups ; Systolic blood pressure in the UO group was lower immediately after insertion compared with the SO and UT groups .


The rate pressure product in the UO group was comparable with that in the UT group during endoscopy , and the SO group showed a continuously higher level than the UO and UT groups .


More than one-half ( 54.4 % ) of patients were ` willing to choose transnasal EGD for next examination ' .


For elderly patients , unsedated transnasal EGD failed to show an advantage over unsedated standard endoscopy .


Transoral thin EGD was estimated to be safe and tolerable .


Urethrocutaneous fistulae ( UCFs ) represent one of the most frequent causes of morbidity after urethroplasty .


Hypospadias can be repaired using different surgical techniques , but-regardless of technique-the incidence of UCF ranges between 10 % and 40 % .


Surgical repair of UCF remains the treatment of choice , even if some patients need further surgery because of recurrences .


Cyanoacrylates have been used as skin suture substitutes , and some evidence suggests a beneficial effect when these adhesives are used as an adjuvant in the management of UCF .


Here we describe the results of management of UCF using 2-octyl cyanoacrylate ( OCA ) compared with surgical repair .


A randomized clinical trial conducted from January 2008 to December 2012 included 42 children with UCF complications after urethroplasty for hypospadias .


Twenty-one children were assigned to receive OCA as ambulatory patients and 21 were treated surgically .


The main outcome variable was closure of the UCF .


The estimated costs of both treatments were also calculated , as were absolute risk reduction ( ARR ) , relative risk reduction ( RRR ) and number needed to treat ( NNT ) to prevent a surgical intervention .


The mean numbers of UCF were 1.3 in the OCA group ( n = 28 ) and 1.1 in the surgical group ( n = 25 ) with no statistically significant difference .


The external orifices measured were 2.96 1.0 mm and 3.8 0.89 mm , respectively ( NS ) .


Sixty per cent of the UCFs treated with cyanoacrylate were completely closed and 68 % of the surgical group healed completely ( NS ) .


More than one reoperation to improve complications was needed in the surgical group ( 3.5 1.2 ) .


The clinical significance of the therapeutic usefulness of OCA was demonstrated by an ARR of 0.08 , RRR of 0.25 and NNT of 12 to avoid further surgical treatment .


The total costs of adhesive applications and reoperations were $ US 14,809.00 and $ US 158,538.50 , respectively .


The results showed a similar success rate for both treatments .


However , sealant use should be considered before surgical treatment because this is a simple outpatient procedure with a reasonable success rate .


ClinicalTrials.gov Identifier : NCT02115191 .


Date : April 13 , 2014 .


Alterations in the vocal folds that involve volume reduction and glottal closure failure result in exaggerated air escape during speech .


For such situations , the use of implants or grafts of different materials has been proposed .


To define the effect of sugarcane biopolymer gel when implanted in the vocal folds of rabbits .


This was an experimental study .


The vocal folds of rabbits injected with sugarcane biopolymer and saline solution were histologically evaluated after 21 and 90 days .


Mild to moderate inflammation and increased volume were observed in all vocal folds injected with biopolymer , when compared to controls .


There were no cases of necrosis or calcification .


This study showed higher inflammatory reaction in cases than in controls and biopolymer biointegration to the vocal fold .


This fibrogenic response with absence of epithelial repercussions suggests that the biopolymer in its gel form can be bioactive and preserve the normal vibratory function of the epithelium .


We show that in spite of producing an inflammatory reaction in vocal fold tissues , the material remained in vocal fold throughout the study period .


Despite growing interest in psychotherapy in child and adolescent headache , efficacy studies in this research field have focused mainly on cognitive-behavioral therapies .


Whereas relaxation and cognitive-behavioral techniques , in particular , have been found to reduce the intensity and frequency of headache in children and adolescents , data on psychodynamic psychotherapy in this population are lacking.Our aim was to explore the effectiveness of a brief psychodynamic psychotherapy program in the treatment of idiopathic headache in childhood and adolescence .


Thirty-three newly diagnosed idiopathic headache sufferers aged 6-18 years , consecutively referred to our outpatient services , were randomized to receive either a brief cycle of psychodynamic psychotherapy ( eight sessions administered at two-week intervals ) or usual care ( clinical interview , neurological examination , counselling , symptomatic therapy ) .


The two groups were evaluated at baseline ( T0 ) and at six months ( T1 ) to be assessed for headache characteristics ( i.e. frequency , intensity and duration ) , quality of life ( i.e. the EuroQoL score ) , patient 's global health status ( i.e. the Clinical Global Impression score ) , and emotional-behavioral symptoms ( i.e. Child Behavior Checklist scores ) .


The two groups were fairly similar with reference to the main demographic and clinical variables .


The T0/T1 comparison showed a statistically significant improvement in headache frequency ( p = 0.005 ) , intensity ( p < 0.001 ) and duration ( p = 0.002 ) , a statistically significant improvement in the CGI score ( p = 0.018 ) , and a borderline improvement in the EuroQoL score ( p = 0.053 ) in the group receiving psychotherapy .


According to our pilot findings , a brief psychodynamic psychotherapy program may be more effective than usual care in children and adolescents with idiopathic headache .


Quinolone-based regimens have been used as the rescue for eradication of Helicobacter pylori .


Sitafloxacin is known to have low minimum inhibitory concentration for H.pylori .


Here , we compared two sitafloxacin-based eradication regimens as rescue for the eradication of H.pylori .


We attempted to eradicate H.pylori in 180 Japanese patients who had never failed in eradication of H.pylori with the triple proton pump inhibitor/amoxicillin/clarithromycin therapy ( 1st line ) and the triple proton pump inhibitor/amoxicillin/metronidazole therapy ( 2nd line ) .


They were assigned to either the triple therapy with rabeprazole 10mg b.i.d. / q.i.d. , amoxicillin 500mg q.i.d , and sitafloxacin 100mg b.i.d. ( RAS ) for 1 or 2 weeks or the triple therapy with rabeprazole 10mg b.i.d. / q.i.d. , metronidazole 250mg b.i.d. , and sitafloxacin 100mg b.i.d. ( RMS ) for 1 or 2 weeks .


Eradication was assessed via the ( 13 ) C-urea breath test and rapid urease test .


Intention-to-treat and per-protocol analyses of eradication rates were 84.1 % ( 37/44 ) and 86.4 % ( 37/43 ) with RAS for 1 week , 88.9 % ( 40/45 ) and 90.9 % ( 40/44 ) for RAS for 2 weeks , 90.9 % ( 40/44 ) and 90.9 % ( 40/44 ) for 1 week-RMS and 87.2 % ( 41/47 ) and 91.1 % ( 41/45 ) with RMS for 2 weeks .


We noted no statistical significant differences in eradication rates among four regimens .


All of the above-described rescue regimens proved relatively equally useful in the eradication of H.pylori .


Of them , RAS for 2 weeks and RMS for 1 or 2 weeks could attain the rescue eradication rates higher than 90 % by per-protocol analysis .


To examine the efficacy of an integrative cognitive training program ( REHACOP ) to improve cognition , clinical symptoms , and functional disability of patients with Parkinson disease ( PD ) .


Forty-two patients diagnosed with PD in Hoehn & Yahr stages 1 to 3 were randomly assigned to either the cognitive training group ( REHACOP ) or the control group ( occupational activities ) for 3 months ( 3 sessions , 60 min/wk ) .


Primary outcomes were change on processing speed , verbal memory , visual memory , executive functioning , and theory of mind .


Secondary outcomes included changes on neuropsychiatric symptoms , depression , apathy , and functional disability .


The trial was registered with clinicaltrials.gov ( NCT02118480 ) .


No baseline group differences were found .


Bootstrapped analysis of variance results showed significant differences in the mean change scores between the REHACOP group and control group in processing speed ( 0.13 [ SE = 0.07 ] vs -0.15 [ SE = 0.09 ] , p = 0.025 ) , visual memory ( 0.10 [ SE = 0.10 ] vs -0.24 [ SE = 0.09 ] , p = 0.011 ) , theory of mind ( 1.00 [ SE = 0.37 ] vs -0.27 [ SE = 0.29 ] , p = 0.013 ) , and functional disability ( -5.15 [ SE = 1.35 ] vs 0.53 [ SE = 1.49 ] , p = 0.012 ) .


Patients with PD receiving cognitive training with REHACOP demonstrated statistically significant and clinically meaningful changes in processing speed , visual memory , theory of mind , and functional disability .


Future studies should consider the long-term effect of this type of intervention .


These findings support the integration of cognitive training into the standard of care for patients with PD .


This study provides Class II evidence that for patients with PD , an integrative cognitive training program improves processing speed , visual memory , theory of mind , and functional disability .


Observational data indicate that carotid artery stenting ( CAS ) is associated with higher incidence of subclinical cerebral microemboli than carotid endarterectomy ( CEA ) .


We hypothesized that CEA would be associated with superior performance on detailed domain-specific cognitive testing compared with CAS .


Patients with > 80 % asymptomatic carotid artery stenosis were randomized to CEA or CAS with side of stenosis balanced across condition .


A robust battery of tests was used to assess the cognitive domains of attention , memory , mood , visual-spatial skills , motor ability , processing speed , and executive functioning 10 days preoperatively and postoperatively at 6 weeks and 6 months .


Tests were administered using standardized conditions and were scored by individuals blinded to treatment allocation .


Baseline cognitive performance was similar between CAS ( n = 29 ) and CEA ( n = 31 ) groups ( P > .05 ) .


Relative to baseline , verbal and visual memory and attention functions substantially improved in the CAS and CEA groups at 6 months ( multiple cognitive tests achieved statistical significance ) .


Compared with CEA , cognitive processing speed ( Stroop Color test : 9.0 vs 7.3 , P = .04 ; and Stroop Word test : 9.0 vs 7.4 , P = .05 ) was superior in the CAS group at 6 weeks .


Executive functioning ( phonemic verbal fluency : 10.6 vs 8.4 , P = .043 ) and motor function ( Grooved Pegboard of nondominant extremity : 45.7 vs 38.9 , P = .022 ) were also superior in the CAS group at 6 months .


Tests of attention , memory , and visual-spatial skills were similar between CAS and CEA patients at 6 weeks and 6 months .


Carotid revascularization improves memory and attention within the first 6 postoperative months .


Compared with CEA , CAS produces improvements in cognitive processing speed , executive functioning , and motor function .


Health utilities measure patients ' preferences for a health state .


To assess health utilities for sofosbuvir-containing therapy for chronic hepatitis C.


The SF-6D utility scores were derived from the SF-36 instrument administered at baseline , during and post-treatment to participants of the previously reported clinical trials of sofosbuvir .


EQ-5D utility scores were also approximated from the SF-36 using a regression model .


Nine hundred and ninety-four patients were enrolled .


Baseline SF-6D and EQ-5D scores were 0.66 0.13 and 0.71 0.22 , respectively ( the POSITRON trial ) , 0.71 0.16 and 0.76 0.23 ( FISSION ) , 0.70 0.14 and 0.75 0.22 ( FUSION ) , 0.72 0.15 and 0.79 0.22 ( NEUTRINO ) .


In all studies , SF-6D and EQ-5D scores were highly correlated with each other .


( r = 0.83-0 .87 , P < 0.0001 ) .


After 12 weeks , patients receiving sofosbuvir + ribavirin ( POSITRON ) had similar utility scores to placebo ( P > 0.05 ) .


Patients receiving 12 and 16 weeks of sofosbuvir + ribavirin ( FUSION ) had similar utility scores ( P > 0.05 ) .


In FISSION , patients receiving sofosbuvir + ribavirin had significantly better utilities compared to patients receiving interferon + ribavirin ( P < 0.001 ) .


Patients receiving sofosbuvir + ribavirin + interferon ( NEUTRINO ) had a decrease in utilities during treatment ( SF-6D : from 0.72 to 0.62 , EQ-5D : 0.79 to 0.65 ; P < 0.0001 ) similar to that observed in patients receiving pegylated interferon + ribavirin for 24 weeks in FISSION ( 0.72 to 0.62 and 0.77 to 0.65 , respectively , P < 0.0001 ) .


After 12 weeks post-treatment , patients with SVR ( FUSION ) had improvement in SF-6D ( +0.026 from baseline , P = 0.013 ) and EQ-5D ( +0.043 , P = 0.013 ) .


In multivariate analyses , baseline depression , anxiety , fatigue , insomnia and treatment-related anaemia were the most consistent predictors of utilities .


Patients ' health utilities are minimally impacted by sofosbuvir + ribavirin treatment , as compared to interferon-based , therapy regardless of treatment duration .


Clinical trials ' numbers : NCT01542788 ( POSITRON ) , NCT01497366 ( FISSION ) , NCT01604850 ( FUSION ) , NCT01641640 ( NEUTRINO ) .


In our study , the efficiency and reliability of lidocaine ( 1 cc/1 % ) application during transrectal ultrasound-guided ( TRUS ) prostate biopsy to levatores prostate was studied .


Levatores prostate was visualized on a cadaver dissection previously .


Eighty outpatients with lower urinary tract complaints or were suspected clinically to have prostate cancer were submitted to TRUS-guided prostate biopsy .


The ages of outpatients were ranging from 45 to 81 .


Patients were randomized in 2 groups : Group-I , with 40 patients submitted to local anesthesia by periprostatic injection of 1 cc 1 % lidocaine before biopsy ; and group-II , with 40 controls the biopsy was performed without local anesthesia .


The anatomical region for anesthesia was determined via dissection .


The name of this anatomical region is levatores prostatae and it has got high nerve density .


The process was explained to the patients and their approvals were obtained .


Levatores prostatae was detected with TRUS before biopsy .


Pain ; related to digital rectal examination ( DRE ) , probe insertion or biopsy , was scored via visual analog scale ( VAS ) .


The patients were evaluated about side effects of lidocaine and early and late complications of biopsy as well .


Both groups were similar in terms of mean age , PSA levels , prostate volume and VAS scores ( p > 0.05 ) .


As for VAS score , on the group submitted to anesthesia was determined 2.34 1.08 , while for VAS score on the group submitted conventional biopsy was determined 5.8 1.6 .


Between two groups , there was a statistical difference in terms of VSA score ( p < 0.05 ) ; but there was no statistical difference about early and late complications of biopsy .


The periprostatic blockage use is clearly associated with more tolerance and patient comfort during TRUS-guided biopsy .


Owing to the local anesthesia introduced to the periprostatic nerve bundle localization in levatores prostate area , the patients could tolerate the pain better .


To assess the morbidity and efficacy of thermal tissue welder instrument for tonsillectomy and compare it with monopolar electrocautery .


IRB approval was obtained at the Wexner Medical Center at Ohio State University for a prospective , randomized , single-blinded , controlled clinical study of 48 healthy adult volunteers undergoing tonsillectomy for chronic tonsillitis and tonsil hypertrophy .


Subjects were randomized to the TW or EC group .


Post-operative pain , pain medication use , return to normal oral intake , return to normal activity , and bleeding were measured on the post-operative log .


We recorded operative time , operating room time , and blood loss .


All procedures were performed by one surgeon to eliminate variations in time and experience .


Operative and patient data were analyzed using a Student T-test and evaluated by cost analysis .


There was a statically significant increase in operative time with the TW taking an average of 4min longer per procedure , p < 0.001 .


However , when total anesthesia time was compared , this did not translate into a statistically significant increase in total operating room time and therefore did not translate into additional cost .


The remaining categories were not significantly different between the two groups .


In 3/23 TW cases , suction cautery was required for hemostasis .


Two patients had 3 occurrences of secondary bleeding in the electrocautery group and none in the tissue welder group .


TW cost increase per case was $ 167 per instrument but averaged $ 700 per case .


While the tissue welder remains a viable option for the adult tonsillectomy procedure , it has not demonstrated in our study the necessary parameters intraoperatively , postoperatively , or via cost analysis to become the choice instrument at our institution .


We can not ignore the increase in cost that may be seen for short and routine procedures without an added benefit to the patient in terms of outcome or safety .


A larger study is needed to determine if secondary bleeding rates are lower with this instrument .


To determine the efficacy of 0.1 % tacrolimus ointment in patients with perianal Crohn 's disease ( CD ) .


This prospective randomized trial enrolled 20 patients with perianal CD as anal fissures and rectal fistulas .


The inclusion criteria were rectovaginal or extrasphincteric fistulas and purulent leakages .


A study group comprised 11 patients , including 9 with anal fissures and 2 with fistulas .


A control group included 9 patients , including 8 with fissures and 1 with fistulas .


The study group received systemic therapy with azathioprine 2 mg/kg/day and tacrolimus ointment 2 mg/day ; the control group had systemic therapy with azathioprine 2 mg/kg/day , hormone ointment 1 mg/day , and metronidazole suppositories 250 mg/day .


Control examination and perianal CD activity index ( PCDAI ) determination were done 6 and 12 weeks after therapy initiation .


At 6 weeks after beginning the study , local examination revealed the signs of anal fissure epithelialization in 5 ( 45.5 % ) of the 11 patients in the study group and in 3 ( 33.3 % ) of the 9 patients in the control one .


At 12 weeks , fissure epithelialization and fistula obliteration were stated in 6 ( 54 % ) patients in the study group and in 3 ( 33 % ) of the 9 patients in the control group .


At 12 weeks , PCDAI in the study and control groups was 2.00 and 4.44 scores ( p = 0.01 ) .


The findings suggest that topical 0.1 % tacrolimus ointment versus antibacterial suppositories and hormone ointments is effective in treating patients with perianal CD .


Topical 0.1 % tacrolimus ointment therapy caused a reduction in PCDAI .


Medication adherence is critical for transplant patients because the consequences of non-adherence can result in allograft loss and may be life threatening .


A prospective study with 74 renal transplant recipients using a sequential control group design was performed to investigate the impact of a pharmaceutical intensified care programme led by a clinical pharmacist on daily drug adherence during the first year after renal transplantation .


Thirty-nine patients of the control group received the already established standardized drug and transplant training , while 35 patients of the intensified care group ( ICG ) received additional inpatient and outpatient pharmaceutical care and counselling by a dedicated clinical pharmacist .


Applied interventions were clustered and classified using the behaviour change technique taxonomy according to Michie .


Adherence to immunosuppressive drug therapy was monitored up to 1 year using a medication event monitoring system , pill count ( PC ) , drug holiday ( DH ) occurrence , Morisky questionnaire and self-report .


Sixty-seven patients ( 35 of the standard care and 32 of the ICG ) were analysed .


Implementation of DA was significantly ( P = 0.014 ) improved in patients of the ICG ( 91 % ) compared with SCG ( 75 % ) during the first year after transplantion .


Daily adherence measures were already improved within 30-40 days after start of intensified patient care and continued throughout the study period .


Intensified care patients also showed significantly better results for taking adherence ( P = 0.006 ) , PC ( P = 0.008 ) and DHs ( P = 0.001 ) .


The additional , intensified pharmaceutical care improved patients ' medication adherence remarkably , suggesting that the applied additional care programme has the potential to improve outcomes after organ transplantation .


Postpartum hemorrhage ( PPH ) is one of the major preventable causes of maternal death in developing countries .


Although the non-parenteral use of misoprostol is a big advantage especially in home births , its benefits in prevention of PPH is still debating .


We aimed to assess the effect and side-effects of prophylactic oral , rectal or vaginal misoprostol on preventing postpartum hemorrhage comparing with no-treatment option .


In a randomized clinical trial , during uncomplicated vaginal delivery , 248 women were assigned to receive one of the five treatment protocols in the third stage of labor which was managed routinely by early cord clamping and controlled cord traction .


Maternal hemoglobin and hematocrit values , the duration of the third stage , and the incidence of blood transfusion was recorded .


There was no statistically significant differences between the antepartum and postpartum values of hemoglobin or hematocrit between the groups .


The mean duration ( 11.8 4.5 min ) of the third stage of labor in oral + vaginal group was significantly shorter .


Shivering was observed totally in 11 women and the differences were not significant between groups .


Despite misoprostol has benefit in treatment of postpartum hemorrhage , it has no remarkable effect in prophylaxis of atony-induced postpartum hemorrhage .


To compare femtosecond laser-assisted cataract surgery with standard phacoemulsification concerning the incidence of postoperative clinical or subclinical macular edema and the correlation between macular thickness and postoperative intraocular inflammation values .


One hundred four eyes of 104 patients were treated by laser-assisted cataract surgery and the fellow 104 eyes underwent phacoemulsification using pulsed ultrasound energy and intraocular lens implantation in this prospective randomized study .


Laser flare photometry was measured preoperatively and at 2 hours , 3 to 4 days , 1 month , 3 months , and 6 months postoperatively .


Retinal thickness was measured by spectral-domain optical coherence tomography .


Two hundred two eyes ( 97 % ) were included and analyzed at 6 months postoperatively .


The mean center thickness in the laser group was 210 24 m at 4 days postoperatively , 214 22 m at 1 month postoperatively , 219 20 m at 3 months postoperatively , and 215 22 m at 6 months postoperatively .


The mean center thickness in the standard group was 211 32 m at 4 days postoperatively , 210 34 m at 1 month postoperatively , 217 29 m at 3 months postoperatively , and 209 30 m at 6 months postoperatively .


Laser flare photometry showed higher levels in the standard group at the first postoperative visit 2 hours after surgery compared with the laser group .


Femtosecond laser-assisted cataract surgery did not obviously influence the incidence of postoperative macular edema .


To evaluate the effects of a bimatoprost/timolol fixed combination ( BTFC ) and a latanoprost/timolol fixed combination ( LTFC ) on diurnal intraocular pressure ( IOP ) and anterior ocular parameters in healthy subjects .


We enrolled 58 healthy subjects in this prospective clinical study .


Thirty subjects were treated with BTFC and 28 subjects were treated with LTFC .


IOP was measured every 2 hours except from 01:00 and 05:00 .


Axial length , corneal curvature , and anterior chamber depth were obtained using the IOL master at baseline and 24 hours later .


Adverse events were assessed by patient interview and by slit lamp examination .


The largest difference in IOP between treated and untreated eyes 8 hours after instillation was 1.67 mmHg in the BTFC group ( p < 0.001 ) .


The largest difference in IOP between treated and untreated eyes 10 hours after instillation was 1.93 mmHg in the LTFC group ( p < 0.001 ) .


For anterior ocular parameters such as axial length , corneal curvature , anterior chamber depth at baseline and 24 hours after instillation , there were no significant differences between the baseline and 24-hour values in either the BTFC or LTFC group .


The most frequently occurring adverse event was conjunctival hyperemia , which was found in 33.3 % ( n = 10 ) of the BTFC group and 25.0 % ( n = 7 ) of the LTFC group ( p = 0.486 ) .


BTFC and LTFC provided a significant reduction in IOP from baseline without changing any anterior ocular parameters .


Our results provide a reference for monocular trials to assess the effect of eye drops in a clinical condition .


Thiazide diuretics are reported to have antioxidant effects and reduce pulse pressure ( PP ) .


The aim of this study was to elucidate whether hydrochlorothiazide additionally exerts such effects in stroke patients under treatment with losartan .


This study was an open-label , randomized , multicenter study .


Patients with a history of chronic stroke and treatment with angiotensin receptor blockers or angiotensin-converting enzyme inhibitors for essential hypertension were enrolled .


Fifty-five hypertensive patients were randomly assigned to two groups : those further treated with hydrochlorothiazide and those further treated with non-diuretic antihypertensive drugs .


Both groups showed a significant decrease in PP over six months ( hydrochlorothiazide group : 6712 mmHg to 5812 , p < 0.001 ; non-diuretic group : 7212 to 6112 , p < 0.001 ) , although no significant differences were observed between the two groups .


The malondialdehyde-modified low-density lipoprotein levels did not change significantly after treatment in either group .


In this study , hydrochlorothiazide treatment did not provide any additional benefits over non-diuretic antihypertensive drugs in terms of antioxidant effects or reducing PP .


Invasive hemodynamic exercise testing is commonly used in the evaluation of patients with suspected heart failure with preserved ejection fraction ( HFpEF ) or pulmonary hypertension .


Saline loading has been suggested as an alternative provocative maneuver , but the hemodynamic changes induced by the 2 stresses have not been compared .


Twenty-six subjects ( aged , 6710 years ; n = 14 HFpEF ; n = 12 control ) underwent right heart catheterization at rest , during supine exercise , and with acute saline loading in a prospective study .


Exercise and saline each increased cardiac output and pressures in the right atrium , pulmonary artery , and pulmonary capillary wedge positions .


Changes in heart rate , blood pressure , rate-pressure product , and cardiac output were greater with exercise compared with saline .


In controls subjects , right atrial pressure , pulmonary arterial pressure , and pulmonary capillary wedge pressure increased similarly with saline and exercise , whereas in HFpEF subjects , exercise led to 2-fold greater increases in right atrial pressure ( 104 versus 63 mm Hg ; P = 0.02 ) , pulmonary arterial pressure ( 228 versus 114 mm Hg ; P = 0.0001 ) , and pulmonary capillary wedge pressure ( 185 versus 104 mm Hg ; P < 0.0001 ) compared with saline .


Systolic reserve assessed by stroke work and cardiac power output was lower in HFpEF subjects with both exercise and saline .


Systemic and pulmonary arterial compliances were enhanced with saline but reduced with exercise .


Exercise elicits greater pulmonary capillary wedge pressure elevation compared with saline in HFpEF but not controls , suggesting that hemodynamic stresses beyond passive stiffness and increased venous return explain the development of pulmonary venous hypertension in HFpEF .


Exercise testing is more sensitive than saline loading to detect hemodynamic derangements indicative of HFpEF .


http://www.clinicaltrials.gov .


Unique identifier : NCT01418248 .


The aim of this study was to evaluate DNA damage and cytokinetic defects , proliferative potential and cell death caused by the frequent use of mouthrinses containing chlorhexidine , triclosan and essential oils in ethanolic solution , compared to a placebo mouthwash .


This double-blind , prospective , randomized clinical trial included 80 Caucasian patients .


Subjects were divided into four groups : Group I used a mouthrinse , Triclosan ; Group II used physiological saline ; Group III used chlorhexidine ; Group IV a mouthrinse with essential oils in ethanolic solution .


All subjects used the mouthrinses for two weeks ( 15 ml , twice a day , rinsing for 30s ) .


Two cell samples per subject were collected , before and after mouthrinse use ( on day 0 and day 15 ) .


Samples were processed as follows : cell collection from cheeks with a cytobrush ; cell centrifuge ; slide preparation , fixation and staining ; and fluorescent microscope analysis .


2000 exfoliated cells were screened for nuclear abnormalities , particularly the presence of micronuclei by means of cytome assay .


No significant differences between study times ( before and after use of mouthwash ) were identified for any of the variables studied ( p > 0.05 ) .


Differences between mouthrinse groups were also compared but no significant differences were found ( p > 0.05 ) .


This study did not observe any genotoxic effect resulting from mouthrinse use .


Recent studies have shown that Gaviscon Double Action Liquid ( a combination alginate-antacid ) administered post-prandially co-localises with the acid pocket , the ` reservoir ' for post-prandial acid reflux .


To compare the effectiveness of Gaviscon Double Action Liquid to an equivalent strength antacid without alginate in controlling post-prandial acid reflux in GERD patients .


Fourteen GERD patients undertook two 3.5-h high-resolution manometry/pH-impedance studies during which they ate a standardised meal .


In a double-blinded randomised crossover design they then took Gaviscon or CVS brand antacid , each with ~ 18mmol/L acid neutralising capacity .


The primary outcome was distal oesophageal acid exposure ; secondary outcomes were number of reflux events , proximal extent of reflux , nadir pH of the refluxate , mechanism of reflux and reflux symptoms scored with a validated instrument .


Ten patients completed the study .


Gaviscon studies had significantly less distal oesophageal acid exposure and greater nadir refluxate pH in the 30-150min post-prandial period than antacid studies .


There were no differences in the number of reflux events ( acid or weakly acidic ) or the number of proximal reflux events ( 15-17cm above the LES ) with either study medication .


Gaviscon Double Action Liquid is more effective than an antacid without alginate in controlling post-prandial oesophageal acid exposure .


However , the number and spatial distribution of reflux events within the oesophagus are similar .


This suggests that Gaviscon main effectiveness relates to its co-localisation with and displacement/neutralisation of the post-prandial acid pocket , rather than preventing reflux .


To compare the differences of clinical effects in female patients with obesity and hyperlipidemia of yang deficiency of spleen and kidney syndrome between warm acupuncture combined with auricular acupuncture and simple warm acupuncture .


One hundred and thirty patients were randomly divided into an observation group and a control group , 65 cases in each one .


In the control group , acupuncture was used at Pishu ( BL 20 ) , Zhongwan ( CV 12 ) , Shenshu ( BL 23 ) , Zhongji ( CV 3 ) , Guanyuan ( CV 4 ) , Mingmen ( GV 4 ) , Taibai ( SP 3 ) , Fenglong ( ST 40 ) , etc. ; warm acupuncture was applied at Pishu ( BL 20 ) , Zhongwan ( CV 12 ) , Shenshu ( BL 23 ) and Zhongji ( CV 3 ) ; the treatment was required once every two days and for 3 months continuously .


In the observation group , based on the treatment in the control group , thumbtack intradermal needles were embedded at auricular points , including pi ( CO13 ) , shen ( CO10 ) , pangguang ( CO9 ) , sanjiao ( CO17 ) , neifenmi ( CO18 ) , neishengzhiqi ( TF2 ) , etc. .


Obesity indices [ body mass ( W ) , obesity degree ( A ) , body mass index ( BMI ) , body fat percentage ( F % ) ] blood lipid indices [ serum total cholesterol ( TC ) , triglyceride ( TG ) , low density lipoprotein ( LDL-C ) , high density lipoprotein ( HDL-C ) ] and clinical efficacy were observed before and after treatment in the two groups .


Results After treatment in the two groups , the obesity indices of W , A , BMI , F % and the blood lipid levels of TC , TG , LDL-C were obviously decreased compared with those before treatment ( all P < 0.01 ) and the HDL-C levels were apparently increased than those before treatment ( both P < 0.01 ) .


After treatment , the improvement of TC and HDL-C in the observation group was superior to that in the control group ( both P < 0.01 ) .


The difference was not statistically significant in the aspect of improving every obesity index between two groups ( all P > .


05 ) .


The comprehensive total effective rate of the observation group was 95.4 % ( 62/65 ) , which was better than 84.6 % ( 55/65 ) of the control group ( P < 0.001 ) .


Warm acupuncture combined with auricular acupuncture and simple warm acupuncture can both benignly adjust abnormal lipid metabolism of obesity patients with hyperlipidemia , and warm acupuncture combined with auricular acupuncture are superior to simple warm acupuncture treatment on antiobesity action and improving the TC and HDL-C levels .


Increasing cases of diabetes , a general lack of routinely operational prevention , and a long history of separating disease prevention and treatment call for immediate engagement of frontier clinicians .


This applies especially to village doctors who work in rural China where the majority of the nation 's vast population lives .


This study aims to develop and test an online Smart Web Aid for Preventing Type 2 Diabetes ( SWAP-DM2 ) capable of addressing major barriers to applying proven interventions and integrating diabetes prevention into routine medical care .


Development of SWAP-DM2 used evolutionary prototyping .


The design of the initial system was followed by refinement cycles featuring dynamic interaction between development of practical and effective standardized operation procedures ( SOPs ) for diabetes prevention and Web-based assistance for implementing the SOPs .


The resulting SOPs incorporated proven diabetes prevention practices in a synergetic way .


SWAP-DM2 provided support to village doctors ranging from simple educational webpages and record maintenance to relatively sophisticated risk scoring and personalized counseling .


Evaluation of SWAP-DM2 used data collected at baseline and 6-month follow-up assessment : ( 1 ) audio recordings of service encounters ; ( 2 ) structured exit surveys of patients ' knowledge , self-efficacy , and satisfaction ; ( 3 ) measurement of fasting glucose , body mass index , and blood pressure ; and ( 4 ) qualitative interviews with doctors and patients .


Data analysis included ( 1 ) descriptive statistics of patients who received SWAP-DM2-assisted prevention and those newly diagnosed with prediabetes and diabetes ; ( 2 ) comparison of the variables assessed between baseline and follow-up assessment ; and ( 3 ) narratives of qualitative data .


The 17 participating village doctors identified 2219 patients with elevated diabetes risk .


Of these , 84.85 % ( 1885/2219 ) consented to a fasting glucose test with 1022 new prediabetes and 113 new diabetes diagnoses made within 6 months .


The prediabetic patients showed substantial improvement from baseline to 6-month follow-up in vegetable intake ( 17.0 % , 43/253 vs 88.7 % , 205/231 ) , calorie intake ( 1.6 % , 4/253 vs 71.4 % , 165/231 ) , leisure-time exercises ( 6.3 % , 16/253 vs 21.2 % , 49/231 ) , body weight ( mean 62.12 kg , SD 9.85 vs mean 58.33 kg , SD 9.18 ) , and body mass index ( mean 24.80 kg/m ( 2 ) , SD 3.21 vs mean 23.36 kg/m ( 2 ) , SD 2.95 ) .


The prediabetic patients showed improvement in self-efficacy for modifying diet ( mean 5.31 , SD 2.81 vs mean 8.53 , SD 2.25 ) , increasing physical activities ( mean 4.52 , SD 3.35 vs mean 8.06 , SD 2.38 ) , engaging relatives ( mean 3.93 , SD 3.54 vs mean 6.93 , SD 2.67 ) , and knowledge about diabetes and risks of an imbalanced diet and inadequate physical activity .


Most participating doctors and patients viewed SWAP-DM2 as useful and effective .


SWAP-DM2 is helpful to village doctors , acceptable to patients , and effective in modifying immediate determinants of diabetes at least in the short term , and may provide a useful solution to the general lack of participation in diabetes prevention by frontier clinicians in rural China .


International Standard Randomized Controlled Trial Number ( ISRCTN ) : 66772711 ; http://www.controlled-trials.com/ISRCTN66772711 .


To assess long-term safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis ( RRMS ) .


Patients completing FTY720 Research Evaluating Effects of Daily Oral Therapy in MS ( FREEDOMS ) were eligible for this dose-blinded , parallel-group extension study , continuing fingolimod 0.5 mg/day or 1.25 mg/day , or switching from placebo to either dose , randomized 1:1 .


Efficacy variables included annualized relapse rate ( ARR ) , brain volume loss ( BVL ) , and confirmed disability progression ( CDP ) .


Between-group analyses were conducted in the intent-to-treat ( ITT ) population from FREEDOMS baseline to end of study .


Within-group analyses compared years 0-2 ( FREEDOMS ) and years 2-4 ( extension ) in the extension ITT population .


Of 1,272 patients ( FREEDOMS ITT population ) , 1,033 were eligible , and 920 enrolled in the extension study ( continuous-fingolimod : 0.5 mg [ n = 331 ] , 1.25 mg [ n = 289 ] ; placebo-fingolimod : 0.5 mg [ n = 155 ] , 1.25 mg [ n = 145 ] ) ; 916 formed the extension ITT population ( n = 330 ; n = 287 ; n = 154 ; n = 145 ) and 773 ( 84 % ) completed .


In the continuous-fingolimod groups , ARR was lower ( p < 0.0001 ) , BVL was reduced ( p < 0.05 ) , and proportionately more patients were free from 3-month CDP ( p < 0.05 ) than in a group comprising all placebo-fingolimod patients .


Within each placebo-fingolimod group , ARR was lower ( p < 0.001 , both ) and BVL was reduced after switching ( p < 0.01 , placebo-fingolimod 0.5 mg ) .


Rates and types of adverse events were similar across groups ; no new safety issues were reported .


Efficacy benefits of fingolimod during FREEDOMS were sustained during the extension ; ARR and BVL were reduced after switching .


This study provides Class IV evidence that long-term fingolimod treatment is well-tolerated and reduces relapse rates , disability progression , and MRI effects in patients with RRMS .


This study examines neurocognitive functioning in a large , well-characterized sample of homeless adults with mental illness and assesses demographic and clinical factors associated with neurocognitive performance .


A total of 1500 homeless adults with mental illness enrolled in the At Home Chez Soi study completed neuropsychological measures assessing speed of information processing , memory , and executive functioning .


Sociodemographic and clinical data were also collected .


Linear regression analyses were conducted to examine factors associated with neurocognitive performance .


Approximately half of our sample met criteria for psychosis , major depressive disorder , and alcohol or substance use disorder , and nearly half had experienced severe traumatic brain injury .


Overall , 72 % of participants demonstrated cognitive impairment , including deficits in processing speed ( 48 % ) , verbal learning ( 71 % ) and recall ( 67 % ) , and executive functioning ( 38 % ) .


The overall statistical model explained 19.8 % of the variance in the neurocognitive summary score , with reduced neurocognitive performance associated with older age , lower education , first language other than English or French , Black or Other ethnicity , and the presence of psychosis .


Homeless adults with mental illness experience impairment in multiple neuropsychological domains .


Much of the variance in our sample 's cognitive performance remains unexplained , highlighting the need for further research in the mechanisms underlying cognitive impairment in this population .


Paracetamol poisoning is common worldwide .


It is treated with intravenous acetylcysteine , but the standard regimen is complex and associated with frequent adverse effects related to concentration , which can cause treatment interruption .


We aimed to ascertain whether adverse effects could be reduced with either a shorter modified acetylcysteine schedule , antiemetic pretreatment , or both .


We undertook a double-blind , randomised factorial study at three UK hospitals , between Sept 6 , 2010 , and Dec 31 , 2012 .


We randomly allocated patients with acute paracetamol overdose to either the standard intravenous acetylcysteine regimen ( duration 2025 h ) or a shorter ( 12 h ) modified protocol , with or without intravenous ondansetron pretreatment ( 4 mg ) .


Masking was achieved by infusion of 5 % dextrose ( during acetylcysteine delivery ) or saline ( for antiemetic pretreatment ) .


Randomisation was done via the internet and included a minimisation procedure by prognostic factors .


The primary outcome was absence of vomiting , retching , or need for rescue antiemetic treatment at 2 h. Prespecified secondary outcomes included a greater than 50 % increase in alanine aminotransferase activity over the admission value .


Analysis was by intention to treat .


This trial is registered with ClinicalTrials.gov ( identifier NCT01050270 ) .


Of 222 patients who underwent randomisation , 217 were assessable 2 h after the start of acetylcysteine treatment .


Vomiting , retching , or need for rescue antiemetic treatment at 2 h was reported in 39 of 108 patients assigned to the shorter modified protocol compared with 71 of 109 allocated to the standard acetylcysteine regimen ( adjusted odds ratio 026 , 975 % CI 013-052 ; p < 00001 ) , and in 45 of 109 patients who received ondansetron compared with 65 of 108 allocated placebo ( 041 , 020-080 ; p = 0003 ) .


Severe anaphylactoid reactions were recorded in five patients assigned to the shorter modified acetylcysteine regimen versus 31 who were allocated to the standard protocol ( adjusted common odds ratio 023 , 975 % CI 012-043 ; p < 00001 ) .


The proportion of patients with a 50 % increase in alanine aminotransferase activity did not differ between the standard ( 9/110 ) and shorter modified ( 13/112 ) regimens ( adjusted odds ratio 060 , 975 % CI 020-183 ) ; however , the proportion was higher with ondansetron ( 16/111 ) than with placebo ( 6/111 ; 330 , 101-1072 ; p = 0024 ) .


In patients with paracetamol poisoning , a 12 h modified acetylcysteine regimen resulted in less vomiting , fewer anaphylactoid reactions , and reduced need for treatment interruption .


This study was not powered to detect non-inferiority of the shorter protocol versus the standard approach ; therefore , further research is needed to confirm the efficacy of the 12 h modified acetylcysteine regimen .


Chief Scientist Office of the Scottish Government .


The presence of anxiety disorders is associated with poorer alcohol use disorder treatment outcomes , but little is known about the impact of alcohol use problems on anxiety disorder treatment outcomes despite their high comorbidity .


The current study examined the impact of alcohol use symptom severity on anxiety disorder treatment outcomes in a multi-site primary care effectiveness study of anxiety disorder treatment .


Data came from the Coordinated Anxiety Learning and Management ( CALM ) effectiveness trial .


Participants ( N = 1004 ) were randomized to an evidence-based anxiety intervention ( including cognitive behavioral therapy and medications ) or usual care in primary care .


Participants completed measures of alcohol use , anxiety , and depression at baseline , 6 - , 12 - , and 18-month follow-up periods .


Patients with alcohol dependence were excluded .


There were no significant moderating ( Treatment Group Alcohol Use Severity ) interactions .


The majority of analyses revealed no predictive effects of alcohol use severity on outcome ; however , alcohol problems at baseline were associated with somewhat higher anxiety and depression symptoms at the 18-month follow-up .


These data indicate that patients with alcohol problems in primary care can be effectively treated for anxiety disorders .


Baseline alcohol problems were associated with some poorer long-term outcomes , but this was evident across CALM and usual care .


These findings provide preliminary evidence that there may be no need to postpone treatment of anxiety disorders until alcohol problems are addressed , at least among those who have mild to moderate alcohol problems .


Replication with more severe alcohol use disorders is needed .


To evaluate the effectiveness of nebulized mucolytic therapy ( N-acetylcysteine ) in treatment of children with acute bronchiolitis .


Prospective randomized , controlled study .


Paediatric Medical Unit of the Children 's Hospital and the Institute of Child Health , Lahore , from November 2011 to April 2012 .


All the patients aged 2 months to 24 months , with the diagnosis of acute viral bronchiolitis were enrolled in the study .


A predesigned proforma was completed after taking parental consent .


All eligible patients were randomly assigned to one of the two groups : group-1 received N-acetylcysteine in nebulized form , and group-2 received salbutamol as a nebulized aerosol .


Both groups were then compared regarding their clinical improvement and duration of stay in the hospital .


The data obtained was analyzed on the statistical software SPSS version 16 .


Descriptive statistics were obtained by frequencies and percentages .


Chi-square test was applied to find p-value .


A total of 100 patients met the inclusion criteria .


The mean age was 3 months .


On the first day of treatment , the mean clinical severity score at baseline were 5.38 2.62 in group-1 and 4.68 2.2 in group-2 .


At day 3 and 5 , it was 2.9 1.48 and 3.30 1.77 in group-1 and 0.88 1.08 and 1.90 1.32 in group-2 respectively .


The clinical severity score after N-acetylcysteine inhalation therapy was better in group-1 on the third but more so on fifth day after hospital admission .


The mean duration of hospitalization was 4.67 2.2 days for the whole population and it differed between the 2 groups : 4.36 1.66 days in group-1 versus 4.98 2.6 days in group-2 .


On the basis of improvement in clinical severity score and early discharge from the hospital , N-acetylcysteine was found to be an effective therapy in acute bronchiolitis .


For patients with active moderate-to-severe Graves ' ophthalmopathy ( GO ) , a course of 4.5 g iv glucocorticoids ( GCs ) is the recommended therapy .


The weekly protocol is preferred because of the potential safety concerns with the daily protocol .


However , evidence for the superiority of different administration protocols is lacking .


We conducted a prospective , randomized trial to compare the efficacy and safety of two protocols of iv 4.5 g methylprednisolone in a total of 80 patients in our institute .


The patients were randomized to receive iv methylprednisolone weekly or daily .


The response rate ( a composite response endpoint including lid width , soft tissue involvement , proptosis , intraocular pressure , Clinical Activity Score [ CAS ] , diplopia , and visual acuity ) was evaluated as the primary outcome , and adverse effects were recorded at each visit .


GO-associated serum cytokines were measured .


We found a significantly greater response rate for the weekly protocol vs the daily protocol at the 12th week ( 76.92 vs 41.03 % ; P = .0025 ) and a similar response rate at the fourth week .


Seven patients on the daily protocol worsened when tapering iv methylprednisolone to oral prednisone in the fourth week .


Patients in both groups showed significant CAS response , and at the 12th week , patients on the weekly protocol showed a nonsignificant trend toward greater CAS response .


Weekly protocol showed significant prolonged retreatment-free survival .


Severe side effects were only observed in two cases , both of which were on the daily protocol .


Furthermore , we observed sustained decreased levels of serum CXCL10 in the 12th week compared to the baseline level ( P = .0009 ) in the patients on the weekly protocol .


The weekly protocol of iv methylprednisolone therapy is more efficient and safer than the daily protocol for patients with active moderate-to-severe GO .


Published data supporting the best practice for patients with atrial fibrillation ( AF ) presenting to the emergency department ( ED ) are limited .


Our objective was to evaluate the impact of an AF clinical protocol initiated in the ED with early follow-up in a specialty AF outpatient clinic .


This was a single-center prospective study of all consented patients with AF who were discharged from the ED through the AF clinical pathway and were then seen in the AF clinic .


The primary endpoint was the rate of 90-day hospitalization/ED visits .


Secondary endpoints included adherence to established AF anticoagulation guidelines , rate of thromboembolic events , quality of life , and patient satisfaction .


One hundred consecutive patients were enrolled in the study .


Within 90 days , 15 had ED visits and 4 were hospitalized , whereas none developed thromboembolic complications .


There were significant increases in the Atrial Fibrillation Effect on QualiTy of life survey quality of life ( 67.3 24.8 vs. 89.2 15.7 ; P < 0.001 ) and patient satisfaction ( 66.4 25.3 vs. 77.9 22.8 ; P < 0.001 ) scores from baseline to 90 days .


Of the 29 patients with CHADS2 score 2 , 20 ( 69 % ) were discharged from the AF clinic with oral anticoagulation .


We describe a novel approach to the care of patients with AF presenting to the ED .


Usage of the ED-initiated AF clinical pathway with early follow-up in a protocol-driven AF clinic was associated with low readmission rates , no thromboembolic complications at 90 days , improved quality of life , and high patient satisfaction .


The role of therapy on improvement of hypsarrhythmia has not been systematically assessed .


This study was performed to assess the efficacy of oral prednisolone and intramuscular adrenocorticotrophin hormone in improving hypsarrhythmia in West syndrome .


Children ( 2 months-2 years ) , with previously untreated West syndrome , were randomized to receive 40-60 IU every other day of intramuscular adrenocorticotrophin hormone or 40-60 mg/day of oral prednisolone for 14 days .


Children with tuberous sclerosis were excluded .


Improvement of hypsarrhythmia was assessed blindly using a hypsarrhythmia severity scale before and after completion of therapy .


Adverse effects were assessed on day 14 using symptom diary .


( Clinical trial registry identifier : SLCTR/2010/010 . )


From 92 newly diagnosed West syndrome infants , 48 were randomized to receive prednisolone and 44 to receive adrenocorticotrophin hormone .


Eighty infants completed the posttreatment evaluation according to specifications .


The hypsarrhythmia severity score , significantly improved with hormonal therapy for 2 weeks ( 10.45 2.65 vs 3.45 2.67 ) ; P < 0.01 .


When individual treatment arms were compared using mean differences in the improvement of scores , improvement in prednisolone arm ( 7.95 2.76 ) was significantly greater than that in the adrenocorticotrophin hormone arm ( 6.00 2.61 ) ; P < 0.01 .


Both forms of therapy were tolerated well .


Frequent crying , irritability , weight gain , increased appetite , and abdominal distension were more common ( but not statistically significant ) with prednisolone .


Hypsarrhythmia severity score improved significantly with both hormonal therapies , but this improvement was significantly better with oral prednisolone than intramuscular adrenocorticotrophin hormone .


This is the first ever documentation of a superior therapeutic role of oral steroids in West syndrome .


The aim of this study was to investigate the effect of a single dose of Brazil nuts on the inflammatory markers of healthy individuals .


A randomized crossover study was conducted with 10 healthy individuals ( mean age 24.7 3.4 y ) .


Each individual was tested four times regarding intake of different portions of Brazil nuts : 0 , 5 , 20 and 50 g.


At each testing period , peripheral blood was collected before and at 1 , 3 , 6 , 9 , 24 , and 48 h after intake of nuts , as well as at 5 and 30 d after intake of various Brazil nut portions .


Blood samples were tested for high-sensitivity to C-reactive protein , interleukin ( IL ) -1 , IL-6 , IL-10 , tumor necrosis factor ( TNF ) - , and interferon ( IFN ) - , aspartate and alanine aminotransferases , albumin , total protein , alkaline phosphatase , gamma-glutamyltransferase , urea , and creatinine .


Consumption of nuts did not affect biochemical parameters for liver and kidney function , indicating absence of hepatic and renal toxicity .


A single intake of Brazil nuts ( 20 or 50 g ) caused a significant decrease in serum IL-1 , IL-6 , TNF - , and IFN - levels ( P < 0.05 ) , whereas serum levels of IL-10 were significantly increased ( P < 0.05 ) .


The results indicate a long-term decrease in inflammatory markers after a single intake of large portions of Brazil nuts in healthy volunteers .


Therefore , the long-term effect of regular Brazil nut consumption on inflammatory markers should be better investigated .


We investigated the manifestations of pediatric loss of control ( LOC ) eating at different stages of pubertal development .


Participants were a nonclinical sample of 468 youth ( 8-17 years ) .


Physical examination determined pubertal stage .


LOC eating and disordered eating attitudes were assessed with the Eating Disorder Examination .


In a randomized crossover design , a subset ( n = 244 ) ate ad libitum from two test meals designed to capture normal and LOC eating .


There were no differences in the prevalence rates or frequency of reported LOC eating episodes across pubertal stages ( ps0 .50 ) .


There were , however , puberty by LOC eating interactions in disordered eating attitudes and palatable food consumption ( ps .05 ) , even after adjusting for age and body composition .


LOC eating was associated with elevated global disordered eating attitudes , weight concern , and shape concern in post-pubertal youth ( ps .001 ) , but not pre-pubertal youth ( ps .49 ) .


In late-puberty , youth with LOC eating consumed less energy from protein ( p < .001 ) and more from carbohydrate ( p = .003 ) and snack-type foods ( p = .02 ) than those without LOC eating , whereas endorsement of LOC eating in pre - or early-to-mid-puberty was not associated with differences in eating behavior ( ps0 .20 ) .


Findings suggest that puberty may be a critical risk period , when LOC eating behaviors in boys and girls may become accompanied by greater weight and shape concerns and more obesogenic food consumption patterns .


Interventions for LOC eating during pre-puberty should be evaluated to determine if they are particularly beneficial for the prevention of exacerbated eating disorder psychopathology and adverse weight outcomes .


No significant differences in the number of immune aberrations were seen between children with or without severe recurrent acute otitis media ( rAOM ) ; however , subnormal values of immunological markers were found more often than expected , and 4 of the 60 children had treatment-requiring immune deficiencies .


Minor immunologic aberrations have been reported to be more frequent in children with rAOM .


Immune investigation is recommended in children with severe rAOM , defined as six or more AOM episodes per year .


The purpose of this study was to describe immunological findings in young children at high risk of developing rAOM , and to relate these to the number of expected aberrations and to the presence of severe rAOM .


A total of 109 children at risk of developing rAOM were offered immune investigation including complement function , immunoglobulins with subclasses and cellular immunity .


Sixty patients were tested , 31 of whom had severe rAOM and 12 of whom did not develop rAOM .


Low levels of IgG2 ( 27 % ) , C1q ( 31 % ) and mannan-binding lectin ( 21 % ) were found up to eight times as often as expected .


Although subnormal values were more frequent among children with severe rAOM , the study was too small to provide reliable evidence of any difference .


Four children were diagnosed with immune deficiencies that required treatment .


It is unknown whether young adults with bipolar disorder are able to benefit from early intervention combining optimised pharmacological treatment and group psychoeducation .


The aim of the present report was to compare the effects of early intervention among patients with bipolar disorder aged 18-25 years to that of patients aged 26 years or older .


Patients were randomised to early treatment in a specialised outpatient mood disorder clinic versus standard care .


The primary outcome was risk of psychiatric re-hospitalisation .


A total of 158 patients with mania/bipolar disorder were included among whom 29 ( 18.4 % ) were between 18 and 25 years and 129 patients were 26 years or older .


For both age groups , the point estimate of the hazard ratio of re-hospitalisation was insignificantly decreased for patients treated in the mood disorder clinic versus standard treatment but more so for patients between 18 and 25 years ( HR 0.33 , 95 % CI 0.10-1 .07 ; p = 0.064 ) than for patients 26 years or older ( HR 0.68 , 95 % CI 0.40-1 .14 , p = 0.14 ) .


Younger adults treated in the mood disorder clinic used mood stabilisers and antipsychotics more in contrast to those treated in standard care .


The differences between the estimates of effects did not reach significance in tests of interactions ( p > 0.2 ) .


The study was based on a post hoc subgroup analysis and due to the small number of patients aged 18-25 years , type II errors can not be excluded .


Although not statistically different , the observed differences of the point estimates was surprisingly larger for young adults suggesting that young adults with bipolar disorder may benefit even more than older adults from early intervention combining pharmacological treatment and group psychoeducation .


Antidepressants are frequently prescribed to treat functional dyspepsia ( FD ) , a common disorder characterized by upper abdominal symptoms , including discomfort or postprandial fullness .


However , there is little evidence of the efficacy of these drugs in patients with FD .


We performed a randomized , double-blind , placebo-controlled trial to evaluate the effects of antidepressant therapy on symptoms , gastric emptying ( GE ) , and meal-induced satiety in patients with FD .


We performed a study at 8 North American sites of patients who met the Rome II criteria for FD and did not have depression or use antidepressants .


Patients ( n = 292 ; 44 15 years old , 75 % were female , 70 % with dysmotility-like FD , and 30 % with ulcer-like FD ) were randomly assigned to groups given placebo , 50 mg amitriptyline , or 10 mg escitalopram for 10 weeks .


The primary end point was adequate relief of FD symptoms for 5 weeks of the last 10 weeks ( of 12 ) .


Secondary end points included GE time , maximum tolerated volume in Nutrient Drink Test , and FD-related quality of life .


An adequate relief response was reported by 39 subjects given placebo ( 40 % ) , 51 given amitriptyline ( 53 % ) , and 37 given escitalopram ( 38 % ) ( P = .05 , after treatment , adjusted for baseline balancing factors including all subjects ) .


Subjects with ulcer-like FD given amitriptyline were > 3-fold more likely to report adequate relief than those given placebo ( odds ratio = 3.1 ; 95 % confidence interval : 1.1-9 .0 ) .


Neither amitriptyline nor escitalopram appeared to affect GE or meal-induced satiety after the 10-week period in any group .


Subjects with delayed GE were less likely to report adequate relief than subjects with normal GE ( odds ratio = 0.4 ; 95 % confidence interval : 0.2-0 .8 ) .


Both antidepressants improved overall quality of life .


Amitriptyline , but not escitalopram , appears to benefit some patients with FD , particularly those with ulcer-like ( painful ) FD .


Patients with delayed GE do not respond to these drugs .


ClinicalTrials.gov ID : NCT00248651 .


Infectious complications and especially anastomotic leakage ( AL ) severely impede the recuperation of patients following colorectal cancer ( CRC ) surgery .


When the normal gut barrier fails , as in AL , pathogenic microorganisms can enter the circulation and may cause severe sepsis which is associated with substantial mortality .


Moreover , AL has a negative impact on the CRC prognosis .


Selective decontamination of the digestive tract ( SDD ) employs oral nonabsorbable antibiotics to eradicate pathogenic microorganisms before elective tumour resection .


In this multicentre randomised clinical trial , perioperative SDD in addition to standard antibiotic prophylaxis is compared with standard antibiotic prophylaxis alone in patients with CRC who undergo elective surgical resection with a curative intent .


The SDD regimen consists of colistin , tobramycin and amphotericin B.


The primary objectives of this randomised clinical trial are to evaluate if perioperative SDD reduces the incidence of clinical AL and its septic consequences as well as other infectious complications .


A main secondary objective is improvement of the cancer-free survival .


A total of 762 patients will be included in total for sufficient power .


It is hypothesised that SDD will reduce clinical AL thereby reducing the morbidity and the mortality in CRC patients .


The trial is investigator-initiated , investigator-driven and supported by the Dutch Digestive Foundation ( WO 11-06 ) and the private Posthumus Meyes Fund .


The trial is registered at ClinicalTrials.gov : NCT01740947 .


Afatinib-an oral irreversible ErbB family blocker-improves progression-free survival compared with pemetrexed and cisplatin for first-line treatment of patients with EGFR mutation-positive advanced non-small-cell lung cancer ( NSCLC ) .


We compared afatinib with gemcitabine and cisplatin-a chemotherapy regimen widely used in Asia-for first-line treatment of Asian patients with EGFR mutation-positive advanced NSCLC .


This open-label , randomised phase 3 trial was done at 36 centres in China , Thailand , and South Korea .


After central testing for EGFR mutations , treatment-naive patients ( stage IIIB or IV cancer [ American Joint Committee on Cancer version 6 ] , performance status 0-1 ) were randomly assigned ( 2:1 ) to receive either oral afatinib ( 40 mg per day ) or intravenous gemcitabine 1000 mg/m ( 2 ) on day 1 and day 8 plus cisplatin 75 mg/m ( 2 ) on day 1 of a 3-week schedule for up to six cycles .


Randomisation was done centrally with a random number-generating system and an interactive internet and voice-response system .


Randomisation was stratified by EGFR mutation ( Leu858Arg , exon 19 deletions , or other ; block size three ) .


Clinicians and patients were not masked to treatment assignment , but the independent central imaging review group were .


Treatment continued until disease progression , intolerable toxic effects , or withdrawal of consent .


The primary endpoint was progression-free survival assessed by independent central review ( intention-to-treat population ) .


This study is registered with ClinicalTrials.gov , NCT01121393 .


910 patients were screened and 364 were randomly assigned ( 242 to afatinib , 122 to gemcitabine and cisplatin ) .


Median progression-free survival was significantly longer in the afatinib group ( 110 months , 95 % CI 97-137 ) than in the gemcitabine and cisplatin group ( 56 months , 51-67 ; hazard ratio 028 , 95 % CI 020-039 ; p < 00001 ) .


The most common treatment-related grade 3 or 4 adverse events in the afatinib group were rash or acne ( 35 [ 146 % ] of 239 patients ) , diarrhoea ( 13 [ 54 % ] ) , and stomatitis or mucositis ( 13 [ 54 % ] ) , compared with neutropenia ( 30 [ 265 % ] of 113 patients ) , vomiting ( 22 [ 195 % ] ) , and leucopenia ( 17 [ 150 % ] ) in the gemcitabine and cisplatin group .


Treatment-related serious adverse events occurred in 15 ( 63 % ) patients in the afatinib group and nine ( 80 % ) patients in the gemcitabine and cisplatin group .


First-line afatinib significantly improves progression-free survival with a tolerable and manageable safety profile in Asian patients with EGFR mutation-positive advanced lung NSCLC .


Afatinib should be considered as a first-line treatment option for this patient population .


Boehringer Ingelheim .


Physical inactivity and advanced age are associated with risk of depressive disorders .


Physical activity can reduce depressive symptoms in older subjects with depressive disorders .


We investigated whether a walking intervention program may decrease the occurrence of depressive symptoms in inactive post-menopausal women without depression .


A total of 121 participants aged 57-75 years were randomly assigned to a six-month moderate intensity walking intervention ( three times a week , 40 minutes per session , supervised and home-based ) or to a control group ( waiting list ) .


Inactivity was assessed using the Physical Activity Questionnaire for the Elderly .


Depression levels were measured pre - and post-intervention with the Beck depression inventory ( BDI ) .


Several baseline measures were considered as possible predictors of post-intervention BDI score .


Participants in the walking intervention showed a significant decrease in depression as compared with controls .


Baseline cognitive-BDI subscore , subjective health status , body mass index and adherence were post-intervention BDI score predictors .


A six-month , three-session per week , moderate intensity walking intervention with a minimal 50 % adherence rate reduces depression in post-menopausal women at risk for depression due to physical inactivity .


This type of walking intervention could be considered as a widely accessible prevention strategy to prevent depressive symptoms in post-menopausal women at risk of depression .


The purpose of this study was to evaluate the efficacy and safety of duloxetine fixed dose in the treatment of children ( 7-11 years ) and adolescents ( 12-17 years ) with major depressive disorder ( MDD ) .


Patients ( n = 463 ) in this 36 week study ( 10 week acute and 26 week extension treatment ) received duloxetine 60mg QD ( n = 108 ) , duloxetine 30mg QD ( n = 116 ) , fluoxetine 20mg QD ( n = 117 , active control ) , or placebo ( n = 122 ) .


Measures included : Children 's Depression Rating Scale-Revised ( CDRS-R ) , treatment-emergent adverse events ( TEAEs ) , and Columbia-Suicide Severity Rating Scale ( C-SSRS ) .


Neither active drug ( duloxetine or fluoxetine ) separated significantly ( p < 0.05 ) from placebo on mean change from baseline to end-point ( 10 weeks ) on the CDRS-R total score .


Total TEAEs and discontinuation for AEs were significantly ( p < 0.05 ) higher only for the duloxetine 60mg group versus the placebo group during acute treatment .


No clinically significant electrocardiogram ( ECG ) or laboratory abnormalities were observed , and no completed suicides or deaths occurred during the study .


A total of 7 ( 6.7 % ) duloxetine 60mg , 6 ( 5.2 % ) duloxetine 30mg , 9 ( 8.0 % ) fluoxetine , and 11 ( 9.4 % ) placebo patients had worsening of suicidal ideation from baseline during acute treatment .


Of the patients with suicidal ideation at baseline , 13/16 ( 81 % ) duloxetine 60mg , 16/17 ( 94 % ) duloxetine 30mg , 11/16 ( 69 % ) fluoxetine , and 13/15 ( 87 % ) placebo had improvement in suicidal ideation at end-point during acute treatment .


One fluoxetine , one placebo , and six duloxetine patients had treatment-emergent suicidal behavior during the 36 week study .


Trial results were inconclusive , as neither the investigational drug ( duloxetine ) nor the active control ( fluoxetine ) separated from placebo on the CDRS-R at 10 weeks .


No new duloxetine safety signals were identified relative to those seen in adults .


Clinical Trial Registry Number ( www.ClinicalTrials.gov ) : NCT00849693 .


The aim of this study was to evaluate early complications following retromuscular mesh repair with those after dual layer suture of the anterior rectus sheath in a randomised controlled clinical trial for abdominal rectus muscle diastasis ( ARD ) .


Patients with an ARD wider than 3 cm and clinical symptoms related to the ARD were included in a prospective randomised study .


They were assigned to either retromuscular inset of a lightweight polypropylene mesh or to dual closure of the anterior rectus fascia using Quill self-locking technology .


All patients completed a validated questionnaire for pain assessment ( Ventral Hernia Pain Questionnaire , VHPQ ) and for quality of life ( SF36 ) prior to and 3 months after surgery .


The most frequently seen adverse event was minor wound infection .


Of the patients , 14/57 had a superficial wound infection ; five related to Quill and nine to mesh repair .


No deep wound infections were reported .


Patient rating for subjective muscular improvement postoperatively was better in the mesh technique group with a mean of 6.9 ( range 0-10 ) compared to a mean of 4.8 ( range 0-10 ) in the Quill group ( p = 0.01 ) .


The pre - and post-operative SF36 scores improved in both groups .


There was no significant difference between the two surgical techniques in terms of early complications and perceived pain at the 3-month follow-up .


Both techniques may be considered equally reliable for ARD repair in terms of adverse outcomes during the early postoperative phase , even though patients operated with a mesh experienced better improvement in muscular strength .


ClinicalTrial.gov : 2009/227 -31 / 3/PE/96 .


The study aims were 1 ) to describe the proportions of individuals who met criteria for melancholic , atypical , and anxious depressive subtypes , as well as subtype combinations , in a large sample of depressed outpatients , and 2 ) to compare subtype profiles on remission and change in depressive symptoms after acute treatment with one of three antidepressant medications .


Participants 18-65 years of age ( N = 1,008 ) who met criteria for major depressive disorder were randomly assigned to 8 weeks of treatment with escitalopram , sertraline , or extended-release venlafaxine .


Participants were classified by subtype .


Those who met criteria for no subtype or multiple subtypes were classified separately , resulting in eight mutually exclusive groups .


A mixed-effects model using the intent-to-treat sample compared the groups ' symptom score trajectories , and logistic regression compared likelihood of remission ( defined as a score 5 on the 16-item Quick Inventory of Depressive Symptomatology-Self-Report ) .


Thirty-nine percent of participants exhibited a pure-form subtype , 36 % met criteria for more than one subtype , and 25 % did not meet criteria for any subtype .


All subtype groups exhibited a similar significant trajectory of symptom reduction across the trial .


Likelihood of remission did not differ significantly between subtype groups , and depression subtype was not a moderator of treatment effect .


There was substantial overlap of the three depressive subtypes , and individuals in all subtype groups responded similarly to the three antidepressants .


The consistency of these findings with those of the Sequenced Treatment Alternatives to Relieve Depression trial suggests that subtypes may be of minimal value in antidepressant selection .


Tuberculosis is epidemic among workers in South African gold mines .