Varenicline can aid short-term smoking abstinence in methadone-maintained smokers .


To determine if weight loss and / or changes in apnea-hypopnea index ( AHI ) improve sleep architecture in overweight / obese adults with type 2 diabetes ( T2D ) and obstructive sleep apnea ( OSA ) .


This was a randomized controlled trial including 264 overweight / obese adults with T2D and OSA .


Participants were randomized to an intensive lifestyle intervention ( ILI ) or a diabetes and support education ( DSE ) control group .


Measures included anthropometry , AHI , and sleep at baseline and year-1 , year-2 , and year-4 follow-ups .


Changes in sleep duration ( total sleep time [ TST ] ) , continuity [ wake after sleep onset ( WASO ) ] , and architecture stage 1 , stage 2 , slow wave sleep , and REM sleep ) from baseline to year 1 , 2 , and 4 did not differ between ILI and DSE .


Repeated-measure mixed-model analyses including data from baseline through year-4 for all participants demonstrated a significant positive association between AHI and stage 1 sleep ( p < 0.001 ) , and a significant negative association between AHI and stage 2 ( p = 0.01 ) and REM sleep ( p < 0.001 ) , whereas changes in body weight had no relation to any sleep stages or TST .


WASO had a significant positive association with change in body weight ( p = 0.009 ) .


Compared to control , the ILI did not induce significant changes in sleep across the 4-year follow-up .


In participants overall , reduced AHI in overweight / obese adults with T2D and OSA was associated with decreased stage 1 , and increased stage 2 and REM sleep .


These sleep architecture changes are more strongly related to reductions in AHI than body weight , whereas WASO may be more influenced by weight than AHI .


NCT00194259 .


To compare the efficacy and safety of intravenous ( IV ) abatacept , a selective T cell costimulation modulator , versus placebo for the treatment of active class III or IV lupus nephritis , when used on a background of mycophenolate mofetil and glucocorticoids .


This was a 12-month , randomized , phase II/III , multicenter , international , double-blind study .


A total of 298 patients were treated in 1 of 3 IV treatment arms : placebo , abatacept at the standard weight-tiered dose ( approximating 10 mg/kg ) , or abatacept at 30 mg/kg for 3 months , followed by the standard weight-tiered dose ( abatacept 30/10 ) .


The primary end point , time to confirmed complete response , was a composite measure that required maintenance of glomerular filtration rate , minimal proteinuria , and inactive urinary sediment over the 52-week treatment period .


There were no differences among treatment arms in the time to confirmed complete response or in the proportion of subjects with confirmed complete response following 52 weeks of treatment .


Treatment with abatacept was associated with greater improvements from baseline in anti-double-stranded DNA antibody , C3 , and C4 levels .


Among 122 patients with nephrotic-range proteinuria , treatment with abatacept resulted in an 20-30 % greater reduction in mean urinary protein-to-creatinine ratio compared with placebo .


Abatacept was well tolerated ; rates of deaths , serious adverse events , and serious infections were similar across treatment arms .


Gastroenteritis and herpes zoster occurred more frequently with abatacept treatment .


Although the primary end point was not met , abatacept showed evidence of biologic activity and was well tolerated in patients with active class III or IV lupus nephritis .


The goals of this study were to investigate the role of a new probiotic preparation ( Lactobacillus reuteri DSM 17938 and L. reuteri ATCC PTA 6475 ) in Helicobacter pylori infection .


Specific probiotic strains play a role in H. pylori infection for their ability to decrease bacterial load and gastritis , prevent antibiotic-associated side effects , and increase the eradication rate .


This is a prospective , double-blind , randomized , placebo-controlled study in a tertiary care setting .


A total of 100 H. pylori-positive naive patients received either L. reuteri combination ( 210 Colony Forming Units ) or placebo during a 3-phase study ( pre-eradication , eradication , and follow-up ) .


All underwent C urea breath test ( C-UBT ) , blood assessments of gastrin-17 ( G17 ) , endoscopy , and the Gastrointestinal Symptom Rating Scale .


Eradication was confirmed by C-UBT 8 weeks after the completion of therapy .


Fifty patients were allocated in each group .


During pre-eradication period , C-UBT decreased by 13 % in L. reuteri combination as compared with a 4 % increase in placebo ( -13.234 % vs. 4.327 % ; P < 0.03 ) .


During eradication , GSRS increased significantly in placebo as compared with L. reuteri combination ( 6.82.9 vs. 43.1 ; P < 0.01 ) .


Significantly less patients in L. reuteri combination as compared with placebo-reported side effects ( 40.9 % vs. 62.8 % ; P < 0.04 ) .


An abnormal G17 value was found in patients receiving placebo as compared with L. reuteri combination ( 28 % vs. 12 % ; P < 0.02 ) .


Eradication rate was 75 % in L. reuteri combination and 65.9 % in placebo ( P = NS ) .


L. reuteri combination increased eradication rate by 9.1 % ( odds ratio : 1.5 ) .


L. reuteri combination alone is able to exert an inhibitory effect on H. pylori growth , and when administered with eradication therapy , it determines a significant reduction in antibiotic-associated side effects .


Moreover , L. reuteri combination was able to decrease serum G17 levels and to ( not significantly ) increase the H. pylori-eradication rate .


The consumption of orange juice may lead to reduced oxidative stress and may enhance the antioxidant defense system .


The aim was to evaluate the effects of the intake of orange juice containing either normal ( NPJ ) or high ( HPJ ) concentrations of polyphenols ( 299 and 745 mg/d , respectively ) on the antioxidant defense system , oxidative stress biomarkers , and clinical signs of metabolic syndrome in 100 nonsmoking subjects who were either overweight or obese .


A randomized , double-blind crossover study was conducted over two 12-wk periods with a 7-wk washout period .


The effects on enzymatic and nonenzymatic blood antioxidant defense systems , urinary and plasma oxidative stress biomarkers , and clinical signs of metabolic syndrome were evaluated before and after an intervention with both of the orange juices .


Paired t tests and linear mixed-effects models were used to evaluate the effects of juice , time , and interactions .


The intake of either NPJ or HPJ led to a decrease in urinary 8-hydroxy-2 ' - deoxyguanosine ( NPJ : 935 134 to 298 19 ng/mg creatinine ; HPJ : 749 84 to 285 17 ng/mg creatinine ) , 8-iso-prostaglandin F2 ( NPJ : 437 68 to 156 14 ng/mg creatinine ; HPJ : 347 43 to 154 13 ng/mg creatinine ) , erythrocyte catalase , and glutathione reductase activities .


A decrease was also observed in body mass index , waist circumference , and leptin ( all P < 0.05 ) .


The NPJ intervention decreased systolic and diastolic blood pressures ( systolic blood pressure : 128 1 to 124 2 mm Hg ; diastolic blood pressure : 79 1 to 76 1 mm Hg ) , whereas the HPJ intervention increased erythrocyte superoxide dismutase ( SOD ) activity ( 17.7 1.5 to 23.1 1.7 U/mg hemoglobin ) .


Our results show that the consumption of either NPJ or HPJ protected against DNA damage and lipid peroxidation , modified several antioxidant enzymes , and reduced body weight in overweight or obese nonsmoking adults .


Only blood pressure and SOD activity were influenced differently by the different flavanone supplementations .


This trial was registered at clinicaltrials.gov as NCT01290250 .


To determine the effects of using a continuous passive motion ( CPM ) device for individuals with poor range of motion ( ROM ) after a total knee replacement ( TKR ) admitted for postacute rehabilitation .


Randomized controlled trial .


Inpatient rehabilitation facility ( IRF ) .


Adults ( N = 141 ) after TKR with initial active knee flexion < 75 on admission to the IRF .


Two randomized groups : group 1 ( n = 71 ) received the conventional 3 hours of therapy per day , and group 2 ( n = 70 ) received the addition of daily CPM use for 2 hours throughout their length of stay .


The primary outcome measure was active knee flexion ROM .


Secondary outcome measures included active knee extension ROM length of stay , estimate of function using the FIM and Timed Up and Go test , girth measurement , and self-reported Western Ontario and McMaster Universities Osteoarthritis Index scores .


All subjects significantly improved from admission to discharge in all outcome measures .


However , there were no statistically significant differences in any of the discharge outcome measures of the CPM group compared with the non-CPM group .


CPM does not provide an additional benefit over the conventional interventions used in an IRF for patient after TKR , specifically in patients with poor initial knee flexion ROM after surgery .


The aim of this study was to investigate the influence of the pharmacokinetics of s.c. anti-TNF agents on the grade of US-detected synovitis in RA patients .


Fifty RA patients were prospectively recruited from the Biologic Therapy Unit of our hospital .


Inclusion criteria were being in treatment with s.c. anti-TNF agents and having had neither changes in therapy nor local corticosteroid injections in the previous 3 months .


Patients underwent clinical , laboratory [ 28-joint DAS ( DAS28 ) and Simplified Disease Activity Index ( SDAI ) ] and US assessment at two time points , i.e. at peak plasma drug concentration and at trough plasma drug concentration .


US assessments were performed blindly to the anti-TNF agent , the administration time and the clinical and laboratory data .


Twenty-eight joints were investigated for the presence and grade ( 0-3 ) of B-mode synovitis and synovial power Doppler signal .


Global indices for B-mode synovitis ( BSI ) and Doppler synovitis ( DSI ) were calculated for 12 joints and for wrist-hand-ankle-foot joints .


B-mode US remission was defined as a BSI < 1 and Doppler US remission as a DSI < 1 .


There were no significant differences between the clinical , laboratory and B-mode and Doppler US parameters at peak time and trough time ( P = 0.132-0 .986 ) .


There were no significant differences between the proportion of patients with active disease and those in remission according to DAS28 , SDAI , B-mode US and Doppler US at peak time and trough time assessments ( P = 0.070-1 ) .


Our results suggested that s.c. anti-TNF pharmacokinetics do not significantly influence US-scored synovitis in RA patients .


In the Third International Study on Syncope of Uncertain Etiology ( ISSUE-3 ) , cardiac pacing was effective in reducing recurrence of syncope in patients with presumed neurally mediated syncope ( NMS ) and documented asystole but syncope still recurred in 25 % of them at 2 years .


We have investigated the role of tilt testing ( TT ) in predicting recurrences .


In 136 patients enrolled in the ISSUE-3 , TT was positive in 76 and negative in 60 .


An asystolic response predicted a similar asystolic form during implantable loop recorder monitoring , with a positive predictive value of 86 % .


The corresponding values were 48 % in patients with non-asystolic TT and 58 % in patients with negative TT ( P = 0.001 versus asystolic TT ) .


Fifty-two patients ( 26 TT + and 26 TT - ) with asystolic neurally mediated syncope received a pacemaker .


Syncope recurred in 8 TT + and in 1 TT - patients .


At 21 months , the estimated product-limit syncope recurrence rates were 55 % and 5 % , respectively ( P = 0.004 ) .


The TT + recurrence rate was similar to that seen in 45 untreated patients ( control group ) , which was 64 % ( P = 0.75 ) .


The recurrence rate was similar between 14 patients with asystolic and 12 with non-asystolic responses during TT ( P = 0.53 ) .


Cardiac pacing was effective in neurally mediated syncope patients with documented asystolic episodes in whom TT was negative ; conversely , there was insufficient evidence of efficacy from this data set in patients with a positive TT even when spontaneous asystole was documented .


Present observations are unexpected and need to be confirmed by other studies .


Clinical Trial Registration - URL : http://www.clinicaltrials.gov .


Unique identifier : NCT01463358 .


Irrational prescribing of over-the-counter ( OTC ) medicines in general practice is common in Southern Europe .


Recent findings from a research project funded by the European Commission ( FP7 ) , the `` OTC SOCIOMED '' , conducted in seven European countries , indicate that physicians in countries in the Mediterranean Europe region prescribe medicines to a higher degree in comparison to physicians in other participating European countries .


In light of these findings , a feasibility study has been designed to explore the acceptance of a pilot educational intervention targeting physicians in general practice in various settings in the Mediterranean Europe region .


This feasibility study utilized an educational intervention was designed using the Theory of Planned Behaviour ( TPB ) .


It took place in geographically-defined primary care areas in Cyprus , France , Greece , Malta , and Turkey .


General Practitioners ( GPs ) were recruited in each country and randomly assigned into two study groups in each of the participating countries .


The intervention included a one-day intensive training programme , a poster presentation , and regular visits of trained professionals to the workplaces of participants .


Reminder messages and email messages were , also , sent to participants over a 4-week period .


A pre - and post-test evaluation study design with quantitative and qualitative data was employed .


The primary outcome of this feasibility pilot intervention was to reduce GPs ' intention to provide medicines following the educational intervention , and its secondary outcomes included a reduction of prescribed medicines following the intervention , as well as an assessment of its practicality and acceptance by the participating GPs .


Median intention scores in the intervention groups were reduced , following the educational intervention , in comparison to the control group .


Descriptive analysis of related questions indicated a high overall acceptance and perceived practicality of the intervention programme by GPs , with median scores above 5 on a 7-point Likert scale .


Evidence from this intervention will estimate the parameters required to design a larger study aimed at assessing the effectiveness of such educational interventions .


In addition , it could also help inform health policy makers and decision makers regarding the management of behavioural changes in the prescribing patterns of physicians in Mediterranean Europe , particularly in Southern European countries .


The purpose of this study was to establish reproducible guidelines for delineating the clinical target volume ( CTV ) of the pelvic lymph nodes ( LN ) by combining the freehand Royal Marsden Hospital ( RMH ) and Radiation Therapy Oncology Group ( RTOG ) vascular expansion techniques .


Seven patients with prostate cancer underwent standard planning computed tomography scanning .


Four different CTVs ( RMH , RTOG , modified RTOG , and Prostate and pelvIs Versus prOsTate Alone treatment for Locally advanced prostate cancer [ PIVOTAL ] trial ) were created for each patient , and 6 different bowel expansion margins ( BEM ) were created to assess bowel avoidance by the CTV .


The resulting CTVs were compared visually and by using Jaccard conformity indices .


The volume of overlap between bowel and planning target volume ( PTV ) was measured to aid selection of an appropriate BEM to enable maximal LN yet minimal normal tissue coverage .


In total , 84 nodal contours were evaluated .


LN coverage was similar in all groups , with all of the vascular-expansion techniques ( RTOG , modified RTOG , and PIVOTAL ) , resulting in larger CTVs than that of the RMH technique ( mean volumes : 287.3 cm ( 3 ) , 326.7 cm ( 3 ) , 310.3 cm ( 3 ) , and 256.7 cm ( 3 ) , respectively ) .


Mean volumes of bowel within the modified RTOG PTV were 19.5 cm ( 3 ) ( with 0 mm BEM ) , 17.4 cm ( 3 ) ( 1-mm BEM ) , 10.8 cm ( 3 ) ( 2-mm BEM ) , 6.9 cm ( 3 ) ( 3-mm BEM ) , 5.0 cm ( 3 ) ( 4-mm BEM ) , and 1.4 cm ( 3 ) ( 5-mm BEM ) in comparison with an overlap of 9.2 cm ( 3 ) seen using the RMH technique .


Evaluation of conformity between LN-CTVs from each technique revealed similar volumes and coverage .


Vascular expansion techniques result in larger LN-CTVs than the freehand RMH technique .


Because the RMH technique is supported by phase 1 and 2 trial safety data , we proposed modifications to the RTOG technique , including the addition of a 3-mm BEM , which resulted in LN-CTV coverage similar to that of the RMH technique , with reduction in bowel and planning target volume overlap .


On the basis of these findings , recommended guidelines including a detailed pelvic LN contouring atlas have been produced and implemented in the PIVOTAL trial .


Depression is expensive to treat , but providing ineffective treatment is more expensive .


Such is the case for many patients who do not respond to antidepressant medication .


To assess the cost-effectiveness of cognitive-behavioural therapy ( CBT ) plus usual care for primary care patients with treatment-resistant depression compared with usual care alone .


Economic evaluation at 12 months alongside a randomised controlled trial .


Cost-effectiveness assessed using a cost-consequences framework comparing cost to the health and social care provider , patients and society , with a range of outcomes .


Cost-utility analysis comparing health and social care costs with quality-adjusted life-years ( QALYs ) .


The mean cost of CBT per participant was 910 .


The difference in QALY gain between the groups was 0.057 , equivalent to 21 days a year of good health .


The incremental cost-effectiveness ratio was 14 911 ( representing a 74 % probability of the intervention being cost-effective at the National Institute of Health and Care Excellence threshold of 20 000 per QALY ) .


Loss of earnings and productivity costs were substantial but there was no evidence of a difference between intervention and control groups .


The addition of CBT to usual care is cost-effective in patients who have not responded to antidepressants .


Primary care physicians should therefore be encouraged to refer such individuals for CBT .


The increasing prevalence and associated cost of treating chronic obstructive pulmonary disease ( COPD ) is unsustainable , and focus is needed on self-management and prevention of hospital admissions .


Telehealth monitoring of patients ' vital signs allows clinicians to prioritise their workload and enables patients to take more responsibility for their health .


This paper reports the results of a pilot randomised controlled trial ( RCT ) of Telehealth-supported care within a community-based COPD supported-discharge service .


A two-arm pragmatic pilot RCT was conducted comparing the standard service with a Telehealth-supported service and assessed the potential for progressing into a full RCT .


The co-primary outcome measures were the proportion of COPD patients readmitted to hospital and changes in patients ' self-reported quality of life .


The objectives were to assess the suitability of the methodology , produce a sample size calculation for a full RCT , and to give an indication of cost-effectiveness for both pathways .


Sixty three participants were recruited ( n = 31 Standard ; n = 32 Telehealth ) ; 15 participants were excluded from analysis due to inadequate data completion or withdrawal from the Telehealth arm .


Recruitment was slow with significant gaps in data collection , due predominantly to an unanticipated 60 % reduction of staff capacity within the clinical team .


The sample size calculation was guided by estimates of clinically important effects and COPD readmission rates derived from the literature .


Descriptive analyses showed that the standard service group had a lower proportion of patients with hospital readmissions and a greater increase in self-reported quality of life compared to the Telehealth-supported group .


Telehealth was cost-effective only if hospital admissions data were excluded .


Slow recruitment rates and service reconfigurations prevented progression to a full RCT .


Although there are advantages to conducting an RCT with data collection conducted by a frontline clinical team , in this case , challenges arose when resources within the team were reduced by external events .


Gaps in data collection were resolved by recruiting a research nurse .


This study reinforces previous findings regarding the difficulty of undertaking evaluation of complex interventions , and provides recommendations for the introduction and evaluation of complex interventions within clinical settings , such as prioritisation of research within the clinical remit .


Current Controlled Trials ISRCTN68856013 , registered Nov 2010 .


The basal insulin analogue LY2605541 , a PEGylated insulin lispro with prolonged duration of action , was previously shown to be associated with modest weight loss in Phase 2 , randomized , open-label trials in type 2 ( N = 288 ) and type 1 ( N = 137 ) diabetes mellitus ( T2DM and T1DM ) , compared with modest weight gain with insulin glargine .


Exploratory analyses were conducted to further characterize these findings .


Pearson correlations between change in body weight and other variables were calculated .


Continuous variables were analysed using a mixed linear model with repeated measurements .


Proportions of subjects with weight loss were analysed using Fisher 's exact test for T2DM and Nagelkerke 's method for T1DM .


Weight loss was more common in LY2605541-treated patients than in patients treated with insulin glargine ( T2DM : 56.9 vs. 40.2 % , p = 0.011 ; T1DM : 66.1 vs. 40.3 % , p < 0.001 ) .


More LY2605541-treated patients experienced 5 % weight loss compared to patients treated with glargine ( T2DM : 4.8 vs. 0 % , p = 0.033 ; T1DM : 11.9 vs. 0.8 % , p < 0.001 ) .


In both the T1DM and T2DM studies , weight change did not correlate with baseline body mass index ( BMI ) , or change in HDL-cholesterol in either treatment group .


No consistent correlations were found across both studies between weight change and any of the variables assessed ; however , weight change was significantly correlated with hypoglycaemia rate in glargine-treated T2DM patients .


In two Phase 2 trials , improved glycaemic control with long-acting basal insulin analogue LY2605541 is associated with weight loss in previously insulin-treated patients .


This weight change is independent of baseline BMI or hypoglycaemia .


Endogenous hydrophobic bile acids may be a pathogenetic factor of biliary complications after orthotopic liver transplantation ( OLT ) .


This study was designed to investigate the effects of hydrophilic ursodeoxycholic acid ( UDCA ) , when administered early after OLT , on serum liver tests and on the incidence of biliary complications .


A total of 112 adult patients undergoing OLT were randomly assigned to one of two groups for receipt of UDCA ( 13 to 15 mg/kg/d for 4 weeks , n = 56 ) or a placebo ( n = 56 ) .


All patients underwent serum liver testing and measurement of serum bile acids during the 4 weeks following OLT.Patients with T-tube underwent measurement of biliary bile acids during the 4 weeks following OLT.Biliary complications , as well as patient and graft survival rates , were analyzed during the follow-up period ( mean of 65.6 months ) .


At post-OLT days 7 , 21 and 28 , the UDCA-treated patients showed significantly lower levels of alanine aminotransferase , aspartate aminotransferase and gamma glutamyl transpeptidase ( all P less than 0.05 ) .


In addition , the UDCA-treated patients showed significantly lower incidence of biliary sludge and casts within the first year post-OLT ( 3.6 % vs. 14.3 % ; x2 = 3.953 , P = 0.047 ) .


However , there were no significant differences for the incidence of other biliary complications at post-OLT years 1 , 3 and 5 .


The graft and patient survival rates were also similar between the two groups .


UDCA , when administered early after OLT , improves results from serum liver tests and decreases the incidence of biliary sludge and casts within the first postoperative year .


Tivantinib , a MET receptor tyrosine kinase inhibitor , demonstrated increased anticancer activity in preclinical and early clinical studies when combined with erlotinib .


Our study aimed to confirm efficacy and safety of the combination in previously treated patients with non-small-cell lung cancer ( NSCLC ) .


Patients with advanced nonsquamous NSCLC previously treated with one to two systemic regimens , including a platinum doublet , were randomly assigned at a 1:1 ratio to receive erlotinib 150 mg daily plus oral tivantinib 360 mg twice daily ( E + T ) or erlotinib plus placebo ( E + P ) until disease progression .


Tumor specimens were evaluated for EGFR and KRAS mutations , MET expression , and MET gene amplification .


The primary end point was overall survival ( OS ) .


Secondary and exploratory objectives included progression-free survival ( PFS ) , OS in molecular subgroups , and safety .


The study enrolled 1,048 patients and was discontinued for futility at the interim analysis .


OS did not improve with E + T versus E + P ( median OS , 8.5 v 7.8 months , respectively ; hazard ratio [ HR ] , 0.98 ; 95 % CI , 0.84 to 1.15 ; P = .81 ) , even though PFS increased ( median PFS , 3.6 v 1.9 months ; HR , 0.74 ; 95 % CI , 0.62 to 0.89 ; P < .001 ) .


Exploratory subgroup analyses suggested OS improvement in patients with high MET expression ( HR , 0.70 ; 95 % CI , 0.49 to 1.01 ) .


Most common adverse events occurring with E + T versus E + P were rash ( 33.1 % v 37.3 % , respectively ) , diarrhea ( 34.6 % v 41.0 % ) , asthenia or fatigue ( 43.5 % v 38.1 % ) , and neutropenia ( grade 3 to 4 ; 8.5 % v 0.8 % ) .


E + T was well tolerated and increased PFS but did not improve OS in the overall nonsquamous NSCLC population .


The aim of the current study was to examine the effect of body weight support treadmill training ( BWSTT ) with power-assisted functional electrical stimulation on functional movement and gait in stroke patients .


Thirty stroke patients were randomly assigned to either the experimental group ( n = 15 ) or the control group ( n = 15 ) .


All subjects participated in the same standard rehabilitation program .


In addition , the experimental group participated in BWSTT with power-assisted functional electrical stimulation for 30 mins per day , five times a week , for 4 wks , and those in the control group participated in BWSTT for 30 minutes per day , five times a week , for 4 wks .


Functional movement was assessed using the Berg Balance Scale , the Timed Up and Go test , and the Stroke Rehabilitation Assessment of Movement .


Gait ability was assessed using an electrical walkway system .


Significant differences in the time factor for functional movement and gait ( P < 0.05 ) were observed in the experimental and control groups .


For the group time interaction , significant improvements were observed in the functional movement ( Berg Balance Scale [ 10.93 vs. 6.00 ] , Timed Up and Go test [ -9.25 vs. -5.25 secs ] , and Stroke Rehabilitation Assessment of Movement scores [ 14.07 vs. 9.80 ] ) and gait ( velocity [ 40.07 vs. 18.64 cm/sec ] , cadence [ 30.57 vs. 17.75 steps per minute ] , paretic side step length [ 19.36 vs. 8.46 cm ] , and stride length [ 30.57 vs. 12.71 cm ] ) ( P < 0.05 ) .


The findings of the current study demonstrated the efficacy of BWSTT with power-assisted functional electrical stimulation on the functional movement and gait ability in stroke patients .


Therefore , the authors suggest that power-assisted functional electrical stimulation may be an effective method for the improvement of functional movement and gait ability of stroke patients when added to BWSTT .


To determine the influence of non-surgical mechanical periodontal treatment on inflammatory markers related to risk for cardiovascular disease .


A total of 64 patients with severe chronic periodontitis was randomly subjected to immediately periodontal treatment ( test group , n = 32 ) or delayed periodontal treatment , without treatment during the study period ( control group , n = 32 ) .


Clinical periodontal and laboratory examinations were performed at baseline ( T0 ) , 2months ( T2 ) , and 6months ( T6 ) after the initial examinations ( Control group ) or completion of periodontal treatment ( Test group ) .


After 2months of periodontal treatment there was a significant reduction of erythrocyte sedimentation rate ( ESR ) and triglycerides ( p = 0.002 , p = 0.004 , respectively ) in the test group .


Median values of C-reactive protein , ESR , total cholesterol , and triglycerides were reduced after 6month of periodontal treatment in the test group ( p < 0.001 , p < 0.001 , p < 0.001 , and p = 0.015 , respectively ) .


The non-surgical periodontal treatment was effective in reducing the levels of systemic inflammation markers and improved the lipid profile in subjects with severe chronic periodontitis .


Organ shortage limits the application of organ transplantation .


The attitudes of intensive care unit ( ICU ) staff play an important role in organ advocating .


The effects of an education program for ICU nurses on organ advocating were uncertain .


The purpose of this study was to explore the effects of an education program based on the Theory of Planned Behavior ( TPB ) on ICU nurses ' attitudes and behavioral intentions to advocate deceased organ donation .


Participants were recruited from 3 different ICU units in medical centers and were randomly assigned to either an experimental group ( n = 61 ) or a control group ( n = 62 ) .


The nurses in the experimental group received comprehensive education programs , and the control groups received a brochure only .


The outcome parameters were measured by questionnaires at 3 different time points of pretest , posttests immediately after education , and 2 months later .


Before education , there was no difference in attitude and behavior intentions between the control and experimental groups .


After TPB training , the nurses significantly changed their attitudes and behavior intentions on organ advocating , both immediately ( P < .01 ) and 2 months after the education program ( P < .01 ) .


In addition , multivariate analysis indicated that TPB training is significantly associated with the change of attitude ( P < .01 ) and behavior intention ( P < .05 ) of organ donation advocacy .


TPB education programs enhanced the ICU nurses ' attitudes and behavioral intentions on advocating organ donation .


Repeated education is advised to increase the participation of ICU nurses on organ advocacy .


To prospectively evaluate ovariectomy and ovariohysterectomy via midline coeliotomy when being employed by supervised final year veterinary students for the purpose of routine canine neutering .


One hundred and eight female dogs of various breeds , presented to a veterinary teaching hospital for neutering , were randomly allocated to one of two surgery groups , ovariectomy or ovariohysterectomy .


The specified procedure was performed by a supervised final year veterinary student .


If the duration of surgery exceeded 2hours or if major surgical or anaesthetic complications occurred , the supervising surgeon intervened to complete the procedure .


Data analysed included age , weight , time from first incision to start of closure , duration of closure , total surgical time and length of incision .


Fifty-four dogs underwent each procedure .


There was no significant difference between the two surgery groups for any of the measured variables .


Ovariectomy is not associated with shorter surgical times or smaller abdominal incisions than ovariohysterectomy when employed by inexperienced surgeons .


As no major complications novel to ovariectomy occurred in this cohort of dogs , this study adds support to the existing literature indicating that ovariectomy is an acceptable alternative to ovariohysterectomy for canine neutering .


We previously showed that intramyocardial bone marrow cell ( BMC ) injection in patients with refractory angina and chronic myocardial ischemia improves myocardial perfusion , cardiac function and disease-related complaints .


Treatment effect varied between patients , but the predictors of response remain to be identified .


Therefore , the aim of the present study was to assess whether patient characteristics , procedural data and baseline measurements influence the response to intramyocardial BMC treatment in a large cohort of refractory angina patients .


In 120 patients ( 64 9 years , 88 % men ) with refractory angina , 97 13 10 ( 6 ) BMCs were injected intramyocardially in regions with stress-inducible ischemia as assessed by single photon emission computed tomography ( SPECT ) .


Canadian Cardiovascular Society angina ( CCS ) class , quality-of-life score , exercise testing , SPECT and magnetic resonance imaging were performed at baseline and at 3 months follow-up demonstrating significant improvements in CCS class , quality-of-life , exercise capacity , myocardial perfusion and left ventricular function ( all variables P < 0.001 ) .


Multivariate analysis was performed to evaluate the influence of patient characteristics , procedural data and baseline measurements on BMC treatment response .


Based on the improvement of myocardial perfusion at stress , diabetes and a large number of ischemic segments at baseline were shown to be independently associated with a large response to BMC therapy .


The present study demonstrates that diabetes and a large number of ischemic segments are predictors of a large response to intramyocardial BMC injection in refractory angina and chronic ischemia .


Furthermore , the safety and efficacy results of previous trials are now confirmed in a larger study population .


We investigated the relationship between hypoxia , human papillomavirus ( HPV ) status and outcome in head and neck squamous cell carcinoma .


Patients with stage III and IV head and neck squamous cell carcinoma treated on phase I and II chemoradiation trials with 70-Gy radiation combined with tirapazamine/cisplatin or cisplatin/fluorouracil ( 5FU ) , hypoxic imaging using [ 18F ] - misonidazole positron emission tomography and known HPV status ( by p16 immunohistochemistry ) were included in this sub-study .


Separate analyses were conducted to consider the impact of tirapazamine on HPV-negative tumours in the phase II trial .


Both p16-positive oropharyngeal tumours and p16-negative head and neck squamous cell carcinoma tumours had a high prevalence of tumour hypoxia ; 14/19 ( 74 % ) and 35/44 ( 80 % ) , respectively .


The distribution of hypoxia ( primary , nodal ) was similar .


On phase II , trial patients with p16-negative hypoxic tumours had worse loco-regional control with cisplatin and 5FU compared with tirapazamine and cisplatin ( P < 0.001 ) and worse failure-free survival ( hazard ratio = 5.18 ; 95 % confidence interval , 1.98-13 .55 ; P = 0.001 ) .


Only 1 out of 14 p16-positive patients on the phase II trial experienced loco-regional failure .


Hypoxia , as assessed by [ 18F ] - misonidazole positron emission tomography , is frequently present in both p16-positive and negative head and neck cancer .


Further research is required to determine whether hypoxic imaging can be used to predict benefit from hypoxia-targeting therapies in patients with p16-negative tumours .


To observe the progression of labor when oxytocin use is limited to the onset of the active stage of labor .


A randomized , prospective controlled study was performed to address the issue of oxytocin infusion after the onset of active labor in 140 patients .


In the study group , infusion of oxytocin was discontinued at the onset of the active phase of labor , which was accepted as a cervical dilatation of 5 cm .


In the control group , incremental oxytocin infusion was administered until 5 cm cervical dilatation , and then was maintained at the same level until delivery .


The primary outcome variable was duration from the beginning of the active phase to delivery .


In the study group , the duration of the active phase of labor was about 30 min longer than in the control group and this difference was significant .


The secondary outcomes of the study were maternal-fetal complications of oxytocin and in both groups there were no significant differences .


It is not reasonable to discontinue oxytocin infusion at the beginning of active labor .


Nevertheless , for an accurate conclusion expanded investigations are needed .


To evaluate intestinal barrier function in neonates undergoing cardiac surgery using lactulose/mannitol ( L/M ) ratio measurements , and to determine correlations with early breast milk feeding .


This was a single-center , prospective , randomized pilot study of 27 term-born neonates ( 37 weeks gestation ) requiring cardiac surgery who were randomized to 1 of 2 preoperative feeding groups : nil per os ( NPO ) or trophic ( 10 mL/kg/day ) breast milk feeds .


At 3 time points ( preoperative [ preop ] , postoperative [ postop ] day 7 , and postop day 14 ) , subjects were administered an oral L/M solution , after which urine L/M ratios were measured using gas chromatography , with higher ratios indicative of increased intestinal permeability .


Trends over time in the mean urine L/M ratios for each group were estimated using a general linear mixed model .


There were no adverse events related to preoperative trophic feeding .


In the NPO group ( n = 13 ) , the mean urine L/M ratio was 0.06 at preop , 0.12 at postop day 7 , and 0.17 at postop day 14 .


In the trophic breast milk feeds group ( n = 14 ) , the mean urine L/M ratio was 0.09 at preop , 0.19 at postop day 7 , and 0.15 at postop day 14 .


In both groups , L/M ratios were significantly higher at postop day 7 and postop day 14 compared with preop ( P < .05 ) .


Neonates have increased intestinal permeability after cardiac surgery extending to at least postop day 14 .


This pilot study was not powered to detect differences in benefit or adverse events comparing the NPO and trophic breast milk feeds groups .


Further studies to identify mechanisms of intestinal injury and therapeutic interventions are warranted .


Registered with ClinicalTrials.gov : NCT01475357 .


Serum procalcitonin is commonly used to differentiate systemic inflammation due to infection from non-infectious causes .


Limited data exist on the value of procalcitonin in predicting relative adrenal insufficiency ( RAI ) .


This study evaluated the value of procalcitonin in predicting RAI and mortality in cirrhotic patients with septic shock .


This was a post-hoc analysis of a randomized placebo-controlled trial that evaluated low-dose hydrocortisone in cirrhotic patients with septic shock .


Extracted first study-day data included serum procalcitonin , baseline serum cortisol , cortisol level after 250 microg - adrenocorticotropic hormone stimulation test and 28 - day mortality .


RAI was defined as a baseline serum cortisol < 10 microg/dL or cortisol not rising by > 9 microg/dL after stimulation .


Procalcitonin > 0.5 ng/mL was considered high .


Forty-five patients had serum procalcitonin measured ( mean = 2.7 + / - 3.2 ng/mL , first and third quartiles were 0.3 and 3.3 ng/mL , respectively ) .


Most ( 78 % ) patients had high procalcitonin levels .


RAI was present in 34 ( 76 % ) patients .


Patients with high procalcitonin were more likely to have RAI ( odds ratio , 4.8 ; 95 % confidence interval , 1.1 - 22.1 ) .


Receiver operator characteristic curve analysis showed that the best cut-off for detecting RAI was 1.0 ng/mL ( sensitivity = 79 % and specificity = 55 % ) .


High serum procalcitonin was not associated with 28 - day mortality ( 80 % for normal procalcitonin and 77 % for high procalcitonin , p = 0.61 ) .


High serum procalcitonin was highly associated with RAI in cirrhotic patients with septic shock .


Procalcitonin was not associated with 28 - day mortality in this patient population .


The efficacy and safety of insulin degludec ( IDeg ) was compared with insulin detemir ( IDet ) , both administered once daily ( OD ) as basal treatment in participants with type 1 diabetes mellitus ( T1DM ) .


The primary outcome was non-inferiority of IDeg to IDet in glycated haemoglobin ( HbA1c ) reduction after 26 weeks .


This multinational , 26-week , controlled , open-label , parallel-group trial randomized adults with T1DM to IDeg or IDet as OD basal insulin treatment combined with mealtime bolus insulin aspart ( IAsp ) .


Participants with T1DM treated with any basal-bolus insulin regimen for 12 months prior to the trial , a mean HbA1c 10.0 % ( 85.8 mmol/mol ) and body mass index ( BMI ) 35.0 kg/m ( 2 ) at screening participated in the trial ( IDeg : N = 302 ; IDet : N = 153 ) .


After 26 weeks , HbA1c decreased 0.73 % ( 8.0 mmol/mol ) ( IDeg ) and 0.65 % ( 7.1 mmol/mol ) ( IDet ) [ estimated treatment difference ( ETD ) IDeg-IDet : -0.09 % ( -0.23 ; 0.05 ) 95 % CI ( -10.0 mmol/mol [ -2.6 ; 0.6 ] 95 % CI ) ; confirming non-inferiority ] .


Mean fasting plasma glucose improved in both groups , and was lower with IDeg than IDet [ ETD IDeg-IDet : -1.66 mmol/l ( -2.37 ; -0.95 ) 95 % CI , p < 0.0001 ] .


The rate of confirmed hypoglycaemia was similar with IDeg and IDet [ 45.83 vs. 45.69 episodes per patient-year of exposure ( PYE ) ; estimated rate ratio ( RR ) IDeg/IDet : 0.98 ( 0.80 ; 1.20 ) 95 % CI , p = 0.86 ] .


The rate of nocturnal confirmed hypoglycaemia was lower with IDeg than IDet [ 4.14 vs. 5.93 episodes per PYE ; RR IDeg/IDet : 0.66 ( 0.49 ; 0.88 ) 95 % CI , p = 0.0049 ] .


Adverse event profiles were similar between groups .


IDeg administered OD in basal-bolus therapy effectively improved long-term glycaemic control in participants with T1DM with a lower risk of nocturnal confirmed hypoglycaemia than IDet .


Human growth hormone ( hGH ) replacement therapy currently requires daily sc injections for years/lifetime , which may be both inconvenient and distressing for patients .


NNC0195-0092 is a novel hGH derivative intended for once-weekly treatment of GH deficiency .


A noncovalent albumin binding moiety is attached to the hGH backbone .


Clearance is reduced as a consequence of a reversible binding to circulating serum albumin , which prolongs the pharmacodynamic ( PD ) effect .


To evaluate safety , local tolerability , pharmacokinetics ( PK ) , and pharmacodynamics ( PD ) of a single dose ( SD ) and multiple doses ( MD ) of NNC0195-0092 .


Randomized , single-center , placebo-controlled , double-blind , SD/MD , dose-escalation trial of 105 healthy male subjects .


NNC0195-0092 sc administration : Five cohorts of eight subjects received one dose of NNC0195-0092 ( 0.01-0 .32 mg/kg ) ( n = 6 ) or placebo ( n = 2 ) .


Sixteen subjects ( equal numbers of Japanese and non-Asian ) received once-weekly doses of NNC0195-0092 ( 0.02-0 .24 mg/kg ; n = 12 ) or placebo ( n = 4 ) for 4 weeks .


Blood samples were drawn for assessment of safety , PK , IGF-1 , and IGF binding protein 3 profiles and anti-drug antibodies .


SD and MD of NNC0195-0092 were well tolerated at all dose levels .


No safety concerns or local tolerability issues were identified .


A dose-dependent IGF-1 response was observed .


IGF-1 profiles suggest that NNC0195-0092 may be suitable for once-weekly dosing , with a clinically relevant dose 0.08 mg/kg/week .


No differences in PK and PD were observed between Japanese and non-Asian subjects .


SD and MD of NNC0195-0092 administered to healthy Japanese and non-Asian male subjects were well tolerated at all doses .


The present trial suggests that NNC0195-0092 has the potential for an efficacious , well-tolerated , once-weekly GH treatment .


To compare long-term outcomes following microwave endometrial ablation ( MEA ) and thermal balloon ablation ( TBall ) .


Follow up of a prospective , double-blind randomised controlled trial at 5years .


A teaching hospital in the UK .


A total of 320 women eligible for and requesting endometrial ablation .


Eligible women were randomised in a 1:1 ratio to undergo MEA or Tball .


Postal questionnaires were sent to participants at a minimum of 5years postoperatively to determine satisfaction with outcome , menstrual status , bleeding scores and quality of life measurement .


Subsequent surgery was ascertained from the women and the hospital operative database .


The primary outcome measure was overall satisfaction with treatment .


Secondary outcomes included evaluation of menstrual loss , change in quality of life scores and subsequent surgery .


Of the women originally randomised 217/314 ( 69.1 % ) returned questionnaires .


Nonresponders were assumed to be treatment failures for data analysis .


The primary outcome of satisfaction was similar in both groups ( 58 % for MEA versus 53 % for TBall , difference 5 % ; 95 % CI -6 to 16 % ) .


Amenorrhoea rates were high following both techniques ( 51 % versus 45 % , difference 6 % ; 95 % CI -5 to 17 % ) .


There was no significant difference in the hysterectomy rates between the two arms ( 9 % versus 7 % , difference 2 % ; 95 % CI -5 to 9 % ) .


At 5years post-treatment there were no significant clinical differences in patient satisfaction , menstrual status , quality of life scores or hysterectomy rates between MEA and Thermachoice 3 , thermal balloon ablation .


Obesity at diagnosis is associated with poor prognosis in women with breast cancer , but few reports have been adjusted for treatment factors .


CALGB 9741 was a randomized trial of dose density and sequence of chemotherapy for node-positive breast cancer .


All patients received doxorubicin , cyclophosphamide , and paclitaxel , dosed by actual body weight .


Height and weight at diagnosis were abstracted from patient records , and the PAM50 assay was performed from archived specimens using the NanoString platform .


Relationships between body mass index ( BMI ) , PAM50 , and recurrence-free and overall survival ( RFS and OS ) were evaluated using proportional hazards regression , adjusting for number of involved nodes , estrogen receptor ( ER ) status , tumor size , menopausal status , drug sequence , and dose density .


All statistical tests were two-sided .


Baseline height and weight were available for 1909 of 2005 enrolled patients ; 1272 additionally had subtype determination by PAM50 .


Median baseline BMI was 27.4 kg/m ( 2 ) .


After 11 years of median follow-up , there were 619 RFS events and 543 deaths .


Baseline BMI was a statistically significant predictor of RFS ( adjusted hazard ratio [ HR ] for each five-unit increase in BMI = 1.08 , 95 % confidence interval [ CI ] = 1.02 to 1.14 , P = .01 ) and OS ( adjusted HR = 1.08 , 95 % CI = 1.01 to 1.14 , P = .02 ) BMI and molecular phenotypes were independent prognostic factors for RFS , with no statistically significant interactions detected .


BMI at diagnosis was a statistically significant prognostic factor in a group of patients receiving optimally dosed chemotherapy .


Additional research is needed to determine the impact of weight loss on breast cancer outcomes and to evaluate whether this impact is maintained across tumor subtypes .


Disodium ethylenediaminetetraacetic acid ( EDTA ) reduced adverse cardiac outcomes in a factorial trial also testing oral vitamins .


This report describes the intent-to-treat comparison of the 4 factorial groups overall and in patients with diabetes .


This was a double-blind , placebo-controlled , 2 2 factorial multicenter randomized trial of 1,708 post-myocardial infarction ( MI ) patients 50 years of age and with creatinine 2.0 mg/dL randomized to receive 40 EDTA chelation or placebo infusions plus 6 caplets daily of a 28-component multivitamin-multimineral mixture or placebo .


The primary end point was a composite of total mortality , MI , stroke , coronary revascularization , or hospitalization for angina .


Median age was 65 years , 18 % were female , 94 % were Caucasian , 37 % were diabetic , 83 % had prior coronary revascularization , and 73 % were on statins .


Five-year Kaplan-Meier estimates for the primary end point was 31.9 % in the chelation + high-dose vitamin group , 33.7 % in the chelation + placebo vitamin group , 36.6 % in the placebo infusion + active vitamin group , and 40.2 % in the placebo infusions + placebo vitamin group .


The reduction in primary end point by double active treatment compared with double placebo was significant ( hazard ratio 0.74 , 95 % CI 0.57-0 .95 , P = .016 ) .


In patients with diabetes , the primary end point reduction of double active compared with double placebo was more pronounced ( hazard ratio 0.49 , 95 % CI 0.33-0 .75 , P < .001 ) .


In stable post-MI patients on evidence-based medical therapy , the combination of oral high-dose vitamins and chelation therapy compared with double placebo reduced clinically important cardiovascular events to an extent that was both statistically significant and of potential clinical relevance .


Benefit from antidepressant treatment such as selective serotonin reuptake inhibitors ( SSRIs ) may depend on individual differences in acute effects on neural emotion processing .


The short ( 'S ' ) allele of the serotonin transporter ( 5-HTT ) - linked polymorphic region ( 5-HTTLPR ) is associated with both negative emotion processing biases and poorer treatment outcomes .


Therefore , the aim of the present study was to explore the effects of 5-HTTLPR on the impact of the SSRI escitalopram during processing of positive and negative emotional images , as well as neutral stimuli .


The study employed a double-blind , randomised , placebo-controlled crossover design on 36 healthy Caucasian female participants who underwent functional magnetic resonance imaging ( fMRI ) scanning following placebo or escitalopram treatment , separated by a 7-day washout period .


Changes in the left amygdala signal with escitalopram treatment during processing of emotional stimuli were linearly related to the 5-HTTLPR 'S ' allele load such that the signal to positive stimuli decreased and the signal to negative stimuli increased with an increasing number of low-expressing 'S ' alleles .


While 5-HTTLPR subgroups were small in size , individual subject changes with treatment and task condition increase confidence in the findings .


While preliminary , our findings comprise the first pharmacogenetic study demonstrating an effect of the 5-HTTLPR 'S ' allele load on escitalopram-induced changes in amygdala activity during emotional processing , consistent with a 5-HTT expression dosage model .


The present findings have implications for the impact of this polymorphism on antidepressant efficacy in patients with mood and anxiety disorders .


As compared with a standard-dose vaccine , a high-dose , trivalent , inactivated influenza vaccine ( IIV3-HD ) improves antibody responses to influenza among adults 65 years of age or older .


This study evaluated whether IIV3-HD also improves protection against laboratory-confirmed influenza illness .


We conducted a phase IIIb-IV , multicenter , randomized , double-blind , active-controlled trial to compare IIV3-HD ( 60 g of hemagglutinin per strain ) with standard-dose trivalent , inactivated influenza vaccine ( IIV3-SD [ 15 g of hemagglutinin per strain ] ) in adults 65 years of age or older .


Assessments of relative efficacy , effectiveness , safety ( serious adverse events ) , and immunogenicity ( hemagglutination-inhibition [ HAI ] titers ) were performed during the 2011-2012 ( year 1 ) and the 2012-2013 ( year 2 ) northern-hemisphere influenza seasons .


A total of 31,989 participants were enrolled from 126 research centers in the United States and Canada ( 15,991 were randomly assigned to receive IIV3-HD , and 15,998 to receive IIV3-SD ) .


In the intention-to-treat analysis , 228 participants in the IIV3-HD group ( 1.4 % ) and 301 participants in the IIV3-SD group ( 1.9 % ) had laboratory-confirmed influenza caused by any viral type or subtype associated with a protocol-defined influenza-like illness ( relative efficacy , 24.2 % ; 95 % confidence interval [ CI ] , 9.7 to 36.5 ) .


At least one serious adverse event during the safety surveillance period was reported by 1323 ( 8.3 % ) of the participants in the IIV3-HD group , as compared with 1442 ( 9.0 % ) of the participants in the IIV3-SD group ( relative risk , 0.92 ; 95 % CI , 0.85 to 0.99 ) .


After vaccination , HAI titers and seroprotection rates ( the percentage of participants with HAI titers 1:40 ) were significantly higher in the IIV3-HD group .


Conclusions : Among persons 65 years of age or older , IIV3-HD induced significantly higher antibody responses and provided better protection against laboratory-confirmed influenza illness than did IIV3-SD .


( Funded by Sanofi Pasteur ; ClinicalTrials.gov number , NCT01427309 . )


Increasing numbers of reports show the beneficial effects of listening to Mozart music in decreasing epileptiform discharges as well as seizure frequency in epileptic children .


There has been no effective method to reduce seizure recurrence after the first unprovoked seizure until now .


In this study , we investigated the effect of listening to Mozart K. 448 in reducing the seizure recurrence rate in children with first unprovoked seizures .


Forty-eight children who experienced their first unprovoked seizure with epileptiform discharges were included in the study .


They were randomly placed into treatment ( n = 24 ) and control ( n = 24 ) groups .


Children in the treatment group listened to Mozart K. 448 daily before bedtime for at least six months .


Two patients in the treatment group were excluded from analysis due to discontinuation intervention .


Finally , forty-six patients were analyzed .


Most of these patients ( 89.1 % ) were idiopathic in etiology .


Seizure recurrence rates and reduction of epileptiform discharges were compared .


The average follow-up durations in the treatment and control groups were 18.6 6.6 and 20.1 5.1 months , respectively .


The seizure recurrence rate was estimated to be significantly lower in the treatment group than the control group over 24 months ( 37.2 % vs. 76.8 % , p = 0.0109 ) .


Significant decreases in epileptiform discharges were also observed after 1 , 2 , and 6 months of listening to Mozart K. 448 when compared with EEGs before listening to music .


There were no significant differences in gender , mentality , seizure type , and etiology between the recurrence and non-recurrence groups .


Although the case number was limited and control music was not performed in this study , the study revealed that listening to Mozart K. 448 reduced the seizure recurrence rate and epileptiform discharges in children with first unprovoked seizures , especially of idiopathic etiology .


We believe that Mozart K. 448 could be a promising alternative treatment in patients with first unprovoked seizures and abnormal EEGs .


Further large-scaled study should be conducted to confirm the effect .


NCT01892605 , date : June-19-2013 .


Better diet quality has been associated with less weight gain over time .


However , few studies have examined the role of diet quality during weight loss .


This study aimed to compare changes in diet quality in overweight/obese adults during a weight loss intervention , and determine whether an association between diet quality score and weight loss exists .


Overweight or obese ( BMI 25-40kg / m2 ) adults , aged 18-60 years , were recruited from the Hunter Region of NSW , Australia and randomized to one of three groups : a standard online weight loss program ( n = 94 ) ; an enhanced version of this online program that provided additional personalized feedback and reminders ( n = 98 ) ; or a wait-list control group ( n = 97 ) .


Diet quality was calculated using the Australian Recommended Food Score ( ARFS ) with dietary data from the Australian Eating Survey ( AES ) Food Frequency Questionnaire at baseline and 12-weeks .


The basic and enhanced groups lost significantly more weight than the control group after 12weeks ( basic -2.23.4 kg , enhanced -3.04.0 kg , control 0.42.4 kg , P < 0.001 ) with no difference between the basic and enhanced groups .


The mean change in ARFS in the enhanced group ( 2.25.7 ) was significantly higher ( P = 0.03 ) than the control group .


There were no significant differences in change in ARFS between the enhanced and basic , or basic and control groups .


The ARFS and the fruit , meat , wholegrain , dairy and water sub-scale scores at 12weeks were significantly associated with greater weight loss ( P < 0.05 ) .


Diet quality improved significantly in the enhanced group compared to controls following 12-weeks intervention .


Furthermore , higher diet quality was associated with greater weight loss .


ACTRN12610000197033 .


To examine the effects of 12 weeks of high-speed resistance training ( RT ) versus low-speed RT on muscle strength [ one repetition of maximum leg-press ( 1RMLP ) and bench-press ( 1RMBP ) , plus dominant ( HGd ) and non-dominant maximum isometric handgrip ] , power [ counter-movement jump ( CMJ ) , ball throwing ( BT ) and 10-m walking sprint ( S10 ) ] , functional performance [ 8-foot up-and-go test ( UG ) and sit-to-stand test ( STS ) ] , and perceived quality of life in older women .


45 older women were divided into a high-speed RT group [ EG , n = 15 , age = 66.33.7 y ] , a low-speed RT group [ SG , n = 15 , age = 68.76.4 y ] and a control group [ CG , n = 15 , age = 66.74.9 y ] .


The SG and EG were submitted to a similar 12-week RT program [ 3 sets of 8 reps at 40-75 % of the one-repetition maximum ( 1 < RM ) , CMJ and BT ] using slow , controlled ( 3s ) concentric muscle actions for the SG and using fast , explosive ( < 1s ) concentric muscle actions for the EG ( 20 % less work per exercise without CMJ and BT ) .


Over the 12-week training period , both RT groups showed small to large clinically significant improvements in the dependent variables ; however , a significant difference was found between the EG and SG for the performance changes in BT , S10 and UG ( 20 % vs. 11 % , p < 0.05 ; 14 % vs. 9 % , p < 0.05 ; 18 % vs. 10 % , p < 0.01 ; respectively ) .


No significant changes were observed for the CG .


Both RT interventions are effective in improving functional capacity , muscle performance and quality of life in older women , although a high-speed RT program induces greater improvements in muscle power and functional capacity .


Multiple health behavior change can ameliorate adverse effects of cancer .


The purpose of this study was to determine the effects of a multiple health behavior change intervention ( CanChange ) for colorectal cancer survivors on psychosocial outcomes and quality of life .


A total of 410 colorectal cancer survivors were randomized to a 6-month telephone-based health coaching intervention ( 11 sessions using acceptance and commitment therapy strategies focusing on physical activity , weight management , diet , alcohol , and smoking ) or usual care .


Posttraumatic growth , spirituality , acceptance , mindfulness , distress , and quality of life were assessed at baseline , 6 and 12months .


Significant intervention effects were observed for posttraumatic growth at 6 ( 7.5 , p < 0.001 ) and 12months ( 4.1 , p = 0.033 ) , spirituality at 6months ( 1.8 , p = 0.011 ) , acceptance at 6months ( 0.2 , p = 0.005 ) , and quality of life at 6 ( 0.8 , p = 0.049 ) and 12months ( 0.9 , p = 0.037 ) .


The intervention improved psychosocial outcomes and quality of life ( physical well-being ) at 6months with most effects still present at 12months .


ACTRN12608000399392 ) .


The combined inhibition of BRAF and MEK is hypothesized to improve clinical outcomes in patients with melanoma by preventing or delaying the onset of resistance observed with BRAF inhibitors alone .


This randomized phase 3 study evaluated the combination of the BRAF inhibitor vemurafenib and the MEK inhibitor cobimetinib .


We randomly assigned 495 patients with previously untreated unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma to receive vemurafenib and cobimetinib ( combination group ) or vemurafenib and placebo ( control group ) .


The primary end point was investigator-assessed progression-free survival .


The median progression-free survival was 9.9 months in the combination group and 6.2 months in the control group ( hazard ratio for death or disease progression , 0.51 ; 95 % confidence interval [ CI ] , 0.39 to 0.68 ; P < 0.001 ) .


The rate of complete or partial response in the combination group was 68 % , as compared with 45 % in the control group ( P < 0.001 ) , including rates of complete response of 10 % in the combination group and 4 % in the control group .


Progression-free survival as assessed by independent review was similar to investigator-assessed progression-free survival .


Interim analyses of overall survival showed 9-month survival rates of 81 % ( 95 % CI , 75 to 87 ) in the combination group and 73 % ( 95 % CI , 65 to 80 ) in the control group .


Vemurafenib and cobimetinib was associated with a nonsignificantly higher incidence of adverse events of grade 3 or higher , as compared with vemurafenib and placebo ( 65 % vs. 59 % ) , and there was no significant difference in the rate of study-drug discontinuation .


The number of secondary cutaneous cancers decreased with the combination therapy .


The addition of cobimetinib to vemurafenib was associated with a significant improvement in progression-free survival among patients with BRAF V600-mutated metastatic melanoma , at the cost of some increase in toxicity .


( Funded by F. Hoffmann-La Roche/Genentech ; coBRIM ClinicalTrials.gov number , NCT01689519 . )


This retrospective study assessed whether dual-source high-pitch computed tomographic angiography ( CTA ) offered advantages over single-source standard-pitch techniques in the evaluation of the ascending aorta .


Twenty patients who received both thoracic dual-source high-pitch and single-source standard-pitch CTAs within 1 year were assessed .


Dual-source CTAs were performed ; standard-pitch imaging used dose-modulated 120 kVp/150 mAs and 0.8 pitch compared with high-pitch protocols employing dose-modulated 120 kVp/250 mAs and 2.4 target pitch .


Radiation dose was documented .


Contrast-to-noise ratios ( CNRs ) at sinuses of the Valsalva ( CNRValsalva ) and ascending aorta ( CNRAorta ) were calculated .


Dose/CNR for each technique was compared with paired t-tests .


Motion at aortic valve , aortic root and ascending aorta were assessed with four-point scales and Mann-Whitney U tests ; longitudinal extension of motion was compared with paired t-tests .


Significantly lower motion scores for high-pitch , compared with standard-pitch acquisitions for aortic annulus , 0 vs. 2 , aortic root , 0 vs. 3 , and ascending aorta , 0 vs. 2 , were achieved .


Significantly reduced longitudinal extension of motion at aortic root , 4.9 mm vs 15.7 mm , and ascending aorta , 4.9 mm vs 21.6 mm , was observed .


Contrast was not impacted : CNRValsalva , 45.6 vs 46.3 , and CNRAorta , 45.3 vs 47.1 .


CTDIvol was significantly decreased for high-pitch acquisitions , 13.9 mGy vs 15.8 mGy .


Dual-source high-pitch CTAs significantly decreased motion artefact without negatively impacting vascular contrast and radiation dose .


Dual-source high-pitch CTA significantly decreased motion artefact of the ascending aorta .


Dual-source high-pitch CTA did not negatively impact on vascular contrast .


Dual-source high-pitch CTA significantly decreased radiation dose compared with single-source standard-pitch acquisitions .


To compare usual diabetes care ( UDC ) to a comprehensive diabetes care intervention condition ( IC ) involving an Internet-based `` diabetes dashboard '' management tool used by clinicians .


We used a parallel-group randomized design .


Diabetes nurses , diabetes dietitians , and providers used the diabetes dashboard as a clinical decision support system to deliver a five-visit , 6-month intervention to 199 poorly controlled ( HbA1c > 7.5 % [ 58 mmol/mol ] ) Latino type 2 diabetic ( T2D ) patients ( mean age 55 years , 60 % female ) at urban community health centers .


We compared this intervention to an established , in-house UDC program ( n = 200 ) for its impact on blood glucose control and psychosocial outcomes .


Recruitment and retention rates were 79.0 and 88.5 % , respectively .


Compared with UDC , more IC patients reached HbA1c targets of < 7 % ( 53 mmol/mol ; 15.8 vs. 7.0 % , respectively , P < 0.01 ) and < 8 % ( 64 mmol/mol ; 45.2 vs. 25.3 % , respectively , P < 0.001 ) .


In multiple linear regression adjusting for baseline HbA1c , adjusted mean SE HbA1c at follow-up was significantly lower in the IC compared with the UDC group ( P < 0.001 ; IC 8.4 0.10 % ; UDC 9.2 0.10 % ) .


The results showed lower diabetes distress at follow-up for IC patients ( 40.4 2.1 ) as compared with UDC patients ( 48.3 2.0 ) ( P < 0.01 ) , and also lower social distress ( 32.2 1.3 vs. 27.2 1.4 , P < 0.01 ) .


There was a similar , statistically significant ( P < 0.01 ) improvement for both groups in the proportion of patients moving from depressed status at baseline to nondepressed at follow-up ( 41.8 vs. 40 % ; no significance between groups ) .


The diabetes dashboard intervention significantly improved diabetes-related outcomes among Latinos with poorly controlled T2D compared with a similar diabetes team condition without access to the diabetes dashboard .


Risk factors for acquired rifampicin resistance ( ARR ) in human immunodeficiency virus ( HIV ) / tuberculosis coinfection , in the highly active antiretroviral therapy ( HAART ) era , needs evaluation .


We studied the impact of HIV and HAART on ARR among patients taking thrice-weekly antituberculosis therapy .


This cross-protocol analysis included patients with newly diagnosed , rifampicin-susceptible pulmonary tuberculosis , with and without HIV , enrolled in clinical trials ( who took > 80 % of medication ) at the National Institute for Research in Tuberculosis between 1999 and 2013 .


All patients received rifampicin and isoniazid for 6 months reinforced with pyrazinamide and ethambutol in the first 2 months , given thrice-weekly throughout the study along with HAART in one of the groups .


Outcomes were categorized and multivariate logistic regression analysis performed to identify risk factors for ARR .


The per-protocol results included patients with tuberculosis : 246 HIV-uninfected patients ( HIV ( - ) TB ( + ) ) , 212 HIV patients not on HAART ( non-HAART ) , and 116 HIV-infected patients on HAART .


Median CD4 counts of the latter 2 groups were 150 and 93 cells/L , respectively , and the median viral loads were 147 000 and 266 000 copies/mL , respectively .


Compared with HIV ( - ) TB ( + ) , the relative risks ( RRs ) for an unfavorable response in the coinfected , non-HAART and HAART groups were 2.1 ( 95 % confidence interval [ CI ] , 1.7-14 .8 ; P < .0001 ) and 2.1 ( 95 % CI , .9 -5.2 ; P = .3 ) , whereas for ARR , the RRs were 21.1 ( 95 % CI , 2.6-184 ; P < .001 ) and 8.2 ( 95 % CI , .6 -104 ; P = .07 ) , respectively .


HIV-infected patients with tuberculosis treated with a thrice-weekly antituberculosis regimen are at a higher risk of ARR , compared with HIV-uninfected patients , in the presence of baseline isoniazid resistance .


HAART reduces but does not eliminate the risk of ARR .


Poor governance and accountability compromise young democracies ' efforts to provide public services critical for human development , including water , sanitation , health , and education .


Evidence shows that accountability agencies like superior audit institutions can reduce corruption and waste in federal grant programs financing service infrastructure .


However , little is know about their effect on compliance with grant reporting and resource allocation requirements , or about the causal mechanisms .


This study protocol for an exploratory randomized controlled trial tests the hypothesis that federal and state audits increase compliance with a federal grant program to improve municipal service infrastructure serving marginalized households .


The AUDIT study is a block randomized , controlled , three-arm parallel group exploratory trial .


A convenience sample of 5 municipalities in each of 17 states in Mexico ( n = 85 ) were block randomized to be audited by federal auditors ( n = 17 ) , by state auditors ( n = 17 ) , and a control condition outside the annual program of audits ( n = 51 ) in a 1:1:3 ratio .


Replicable and verifiable randomization was performed using publicly available lottery numbers .


Audited municipalities were included in the national program of audits and received standard audits on their use of federal public service infrastructure grants .


Municipalities receiving moderate levels of grant transfers were recruited , as these were outside the auditing sampling frame -- and hence audit program -- or had negligible probabilities of ever being audited .


The primary outcome measures capture compliance with the grant program and markers for the causal mechanisms , including deterrence and information effects .


Secondary outcome measure include differences in audit reports across federal and state auditors , and measures like career concerns , political promotions , and political clientelism capturing synergistic effects with municipal accountability systems .


The survey firm and research assistants assessing outcomes were blind to treatment status .


This study will improve our understanding of local accountability systems for public service delivery in the 17 states under study , and may have downstream policy implications .


The study design also demonstrates the use of verifiable and replicable randomization , and of sequentially partitioned hypotheses to reduce the Type I error rate in multiple hypothesis tests .


Controlled-trials .


com Identifier ISRCTN22381841 : Date registered 02/11/2012 .


Since the 2008 inception of universal childhood influenza vaccination , national rates have risen more dramatically among younger children than older children and reported rates across racial/ethnic groups are inconsistent .


Interventions may be needed to address age and racial disparities to achieve the recommended childhood influenza vaccination target of 70 % .


To evaluate an intervention to increase childhood influenza vaccination across age and racial groups .


In 2011-2012 , a total of 20 primary care practices treating children were randomly assigned to the intervention and control arms of a cluster randomized controlled trial to increase childhood influenza vaccination uptake using a toolkit and other strategies including early delivery of donated vaccine , in-service staff meetings , and publicity .


The average vaccination differences from pre-intervention to the intervention year were significantly larger in the intervention arm ( n = 10 practices ) than the control arm ( n = 10 practices ) ; for children aged 9-18 years ( 11.1 pct pts intervention vs 4.3 pct pts control , p < 0.05 ) ; for non-white children ( 16.7 pct pts intervention vs 4.6 pct pts control , p < 0.001 ) ; and overall ( 9.9 pct pts intervention vs 4.2 pct pts control , p < 0.01 ) .


In multi-level modeling that accounted for person - and practice-level variables and the interactions among age , race , and intervention , the likelihood of vaccination increased with younger age group ( 6-23 months ) ; white race ; commercial insurance ; the practice 's pre-intervention vaccination rate ; and being in the intervention arm .


Estimates of the interaction terms indicated that the intervention increased the likelihood of vaccination for non-white children in all age groups and white children aged 9-18 years .


A multi-strategy intervention that includes a practice improvement toolkit can significantly improve influenza vaccination uptake across age and racial groups without targeting specific groups , especially in practices with large percentages of minority children .


Little evidence exists on which exercise modality is optimal for obese adolescents .


To determine the effects of aerobic training , resistance training , and combined training on percentage body fat in overweight and obese adolescents .


Randomized , parallel-group clinical trial at community-based exercise facilities in Ottawa ( Ontario ) and Gatineau ( Quebec ) , Canada , among previously inactive postpubertal adolescents aged 14 to 18 years ( Tanner stage IV or V ) with body mass index at or above the 95th percentile for age and sex or at or above the 85th percentile plus an additional diabetes mellitus or cardiovascular risk factor .


After a 4-week run-in period , 304 participants were randomized to the following 4 groups for 22 weeks : aerobic training ( n = 75 ) , resistance training ( n = 78 ) , combined aerobic and resistance training ( n = 75 ) , or nonexercising control ( n = 76 ) .


All participants received dietary counseling , with a daily energy deficit of 250 kcal .


The primary outcome was percentage body fat measured by magnetic resonance imaging at baseline and 6 months .


We hypothesized that aerobic training and resistance training would each yield greater decreases than the control and that combined training would cause greater decreases than aerobic or resistance training alone .


Decreases in percentage body fat were -0.3 ( 95 % CI , -0.9 to 0.3 ) in the control group , -1.1 ( 95 % CI , -1.7 to -0.5 ) in the aerobic training group ( P = .06 vs controls ) , and -1.6 ( 95 % CI , -2.2 to -1.0 ) in the resistance training group ( P = .002 vs controls ) .


The -1.4 ( 95 % CI , -2.0 to -0.8 ) decrease in the combined training group did not differ significantly from that in the aerobic or resistance training group .


Waist circumference changes were -0.2 ( 95 % CI , -1.7 to 1.2 ) cm in the control group , -3.0 ( 95 % CI , -4.4 to -1.6 ) cm in the aerobic group ( P = .006 vs controls ) , -2.2 ( 95 % CI -3.7 to -0.8 ) cm in the resistance training group ( P = .048 vs controls ) , and -4.1 ( 95 % CI , -5.5 to -2.7 ) cm in the combined training group .


In per-protocol analyses ( 70 % adherence ) , the combined training group had greater changes in percentage body fat ( -2.4 , 95 % CI , -3.2 to -1.6 ) vs the aerobic group ( -1.2 ; 95 % CI , -2.0 to -0.5 ; P = .04 vs the combined group ) but not the resistance group ( -1.6 ; 95 % CI , -2.5 to -0.8 ) .


Aerobic , resistance , and combined training reduced total body fat and waist circumference in obese adolescents .


In more adherent participants , combined training may cause greater decreases than aerobic or resistance training alone .


clinicaltrials.gov Identifier : NCT00195858 .


To assess the safety and efficacy of combining oncolytic adenovirus-mediated cytotoxic gene therapy ( OAMCGT ) with intensity modulated radiation therapy ( IMRT ) in intermediate-risk prostate cancer .


Forty-four men with intermediate-risk prostate cancer were randomly assigned to receive either OAMCGT plus IMRT ( arm 1 ; n = 21 ) or IMRT only ( arm 2 ; n = 23 ) .


The primary phase 2 endpoint was acute ( 90 days ) toxicity .


Secondary endpoints included quality of life ( QOL ) , prostate biopsy ( 12-core ) positivity at 2 years , freedom from biochemical/clinical failure ( FFF ) , freedom from metastases , and survival .


Men in arm 1 exhibited a greater incidence of low-grade influenza-like symptoms , transaminitis , neutropenia , and thrombocytopenia than men in arm 2 .


There were no significant differences in gastrointestinal or genitourinary events or QOL between the 2 arms .


Two-year prostate biopsies were obtained from 37 men ( 84 % ) .


Thirty-three percent of men in arm 1 were biopsy-positive versus 58 % in arm 2 , representing a 42 % relative reduction in biopsy positivity in the investigational arm ( P = .13 ) .


There was a 60 % relative reduction in biopsy positivity in the investigational arm in men with < 50 % positive biopsy cores at baseline ( P = .07 ) .


To date , 1 patient in each arm exhibited biochemical failure ( arm 1 , 4.8 % ; arm 2 , 4.3 % ) .


No patient developed hormone-refractory or metastatic disease , and none has died from prostate cancer .


Combining OAMCGT with IMRT does not exacerbate the most common side effects of prostate radiation therapy and suggests a clinically meaningful reduction in positive biopsy results at 2 years in men with intermediate-risk prostate cancer .


Medication reconciliation improves congruence in cross sectional patient courses .


Our regional electronic medical record ( EMR ) integrates the shared medication record ( SMR ) which provides full access to current medication and medication prescriptions for all citizens in Denmark .


We studied whether our SMR integration could facilitate medication reconciliation .


Patients admitted to the emergency department for hospitalization were randomised to consultation using EMR with or without the integrated SMR access .


Observed time used for medication reconciliation was the primary efficacy parameter .


A total of 62 consecutive patient consultations were randomised including 39 with more than five prescriptions .


EMR had data from previous consultations for 46 patients , 59 patients provided information on medication .


In all , 18 junior physicians in early postgraduate medical training each participated with a median of three consultations ( range 1-9 ) .


Time expenditure for medicine reconciliation was 5:27 min. : sec .


( range : 2:00 -15:37 ) with access to SMR integration and 4:15 min. : sec .


( 1:15 -12:00 ) without SMR access .


The number of active medicine prescriptions was eight and nine , respectively .


Incorporating SMR did not increase the work load .


Physicians judged the SMR integration and workflow as being useful .


Patients unambiguously sup-ported physicians ' use of SMR in this setting .


Integration of information on individuals ' medication from a national SMR into a hospital EMR was feasible and useful , and it did not increase time expenditure for medication reconciliation .


not relevant .


Pegfilgrastim is a pegylated form of filgrastim , a recombinant protein of granulocyte colony-stimulating factor , that is used to reduce the risk of febrile neutropenia ( FN ) .


Here , we report the results of a phase III trial of pegfilgrastim in breast cancer patients receiving docetaxel and cyclophosphamide ( TC ) chemotherapy .


We conducted a double-blind , placebo-controlled , randomized trial to determine the efficacy of pegfilgrastim in reducing the risk of FN in early-stage breast cancer patients .


A total of 351 women ( 177 in the pegfilgrastim group and 174 in the placebo group ) between 20 and 69 years of age with stage I-III invasive breast carcinoma who were to receive TC chemotherapy ( docetaxel 75 mg/m ( 2 ) and cyclophosphamide 600 mg/m ( 2 ) every 3 weeks ) as either neoadjuvant or adjuvant therapy were enrolled ; 346 of these patients were treated with either pegfilgrastim ( n = 173 ) or placebo ( n = 173 ) .


The incidence of FN was significantly lower in the pegfilgrastim group than in the placebo group ( 1.2 vs. 68.8 % , respectively ; P < 0.001 ) .


In addition , patients in the pegfilgrastim group required less hospitalization and antibiotics for FN .


Most adverse events were consistent with those expected for breast cancer subjects receiving TC chemotherapy .


Pegfilgrastim is safe and significantly reduces the incidence of FN in breast cancer patients .


Cerebral palsy ( CP ) is a disabling condition characterized by the motor impairment , which is difficult to be ameliorated .


In the brain of infants with CP , there are persistent pathomechanisms including accentuated neuroinflammation .


Since erythropoietin was demonstrated to have neuroprotective effect via anti-inflammatory and anti-apoptotic properties , we hypothesized that the administration of recombinant human EPO ( rhEPO ) could help children with CP , especially young infants .


We investigated the therapeutic efficacy of rhEPO for infants with CP , who had been undergoing active rehabilitation in hospitalized setting to eliminate treatment bias .


Twenty infants with CP were randomly divided into EPO or control group equally .


We compared the changes in the Gross Motor Function Measure ( GMFM ) and the Bayley Scales of Infant Development-II ( BSID-II ) scores during one month of hospitalization between two groups .


The improvements after 1 month on the GMFM A and GMFM total scores differed significantly between the groups ( p = 0.003 , p = 0.04 , respectively ) .


However , the changes after 6 months were not different between the two groups .


The scores of BSID-II did not show any differences at 1-month and 6-months post-treatment .


These results indicated that rhEPO could have therapeutic efficacy for infants with CP during the active rehabilitation and anti-inflammation was suggested to be one of its therapeutic mechanisms .


The authors aimed to assess the effect of lower extremity nerve decompression surgery for painful diabetic polyneuropathy on pain and sensibility .


The study was conducted as a single-center randomized controlled trial of one intervention with 1-year follow-up .


Forty-two patients with painful diabetic neuropathy were included .


After randomization , the lower extremity nerves were decompressed at four sites in one limb .


The contralateral limb was used as control ( within-patient comparison ) .


All patients were assessed preoperatively and at 3 , 6 , and 12 months postoperatively .


Primary outcome was the visual analogue scale score 12 months after surgery .


Secondary outcomes were Semmes Weinstein monofilament testing and two-point discrimination outcomes at 3 , 6 , and 12 months .


Visual analogue scale scores improved significantly from a mean of 6.1 ( 95 percent CI , 5.5 to 6.7 ) preoperatively to 3.5 ( 95 percent CI , 2.5 to 4.4 ) at 12 months postoperatively ( p < 0.001 ) .


The score was also significantly lower compared with the control leg score of 5.3 ( 95 percent CI , 4.4 to 6.2 ; p < 0.001 ) at 12 months .


Overall , 73.7 percent of the patients improved their score on the visual analogue scale , of which 35.7 percent had a decrease of more than five points .


Surgical decompression of the nerves of the lower extremity can be added as a therapeutic option for patients with painful diabetic neuropathy who show signs of chronic nerve compression by means of a positive Tinel or other diagnostic criteria , when pain medication fails to reduce pain to an acceptable standard .


Therapeutic , I.


Acetylsalicylic acid is one of the most used analgesics to treat an acute migraine attack .


Next to the inhibitory effects on peripheral prostaglandin synthesis , central mechanisms of action have also been discussed .


Using a standardized model for trigeminal-nociceptive stimulation during fMRI scanning , we investigated the effect of acetylsalicylic acid on acute pain compared to saline in 22 healthy volunteers in a double-blind within-subject design .


Painful stimulation was applied using gaseous ammonia and presented in a pseudo-randomized order with several control stimuli .


All participants were instructed to rate the intensity and unpleasantness of every stimulus on a VAS scale .


Based on previous results , we hypothesized to find an effect of ASA on central pain processing structures like the ACC , SI and SII as well as the trigeminal nuclei and the hypothalamus .


Even though we did not find any differences in pain ratings between saline and ASA , we observed decreased BOLD signal changes in response to trigemino-nociceptive stimulation in the ACC and SII after administration of ASA compared to saline .


This finding is in line with earlier imaging results investigating the effect of ASA on acute pain .


Contrary to earlier findings from animal studies , we could not find an effect of ASA on the trigeminal nuclei in the brainstem or within the hypothalamic area .


Taken together our study replicates earlier findings of an attenuating effect of ASA on pain processing structures , which adds further evidence to a possibly central mechanism of action of ASA .


The Prostate Cancer Prevention Trial ( PCPT ) was a 7-year randomized , double-blind , placebo-controlled trial of the efficacy of finasteride for the prevention of prostate cancer with a primary outcome of histologically determined prevalence of prostate cancer at the end of 7 years .


A systematic modeling process using logistic regression identified factors available at year 6 that are associated with end-of-study ( EOS ) biopsy adherence at year 7 , stratified by whether participants were ever prompted for a prostate biopsy by year 6 .


Final models were evaluated for discrimination .


At year 6 , 13,590 men were available for analysis .


Participants were more likely to have the EOS biopsy if they were adherent to study visit schedules and procedures and/or were in good health ( P < 0.01 ) .


Participants at larger sites and/or sites that received retention and adherence grants were also more likely to have the EOS biopsy ( P < 0.05 ) .


Our results show good adherence to study requirements 1 year before the EOS biopsy was associated with greater odds that a participant would comply with the invasive EOS requirement .


Monitoring adherence behaviors may identify participants at risk of nonadherence to more demanding study end points .


Such information could help frame adherence intervention strategies in future trials .


Chemoprevention offers a promising strategy for prevention of malaria in African children .


However , the optimal chemoprevention drug and dosing strategy is unclear in areas of year-round transmission and resistance to many antimalarial drugs .


To compare three available regimens , we conducted an open-label randomized controlled trial of chemoprevention in Ugandan children .


This study was conducted between June 28 , 2010 , and September 25 , 2013.400 infants were enrolled and 393 randomized at 6 mo of age to no chemoprevention , monthly sulfadoxine-pyrimethamine ( SP ) , daily trimethoprim-sulfamethoxazole ( TS ) , or monthly dihydroartemisinin-piperaquine ( DP ) .


Study drugs were administered at home without supervision .


Piperaquine ( PQ ) levels were used as a measure of compliance in the DP arm .


Participants were given insecticide-treated bednets , and caregivers were encouraged to bring their child to a study clinic whenever they were ill .


Chemoprevention was stopped at 24 mo of age , and participants followed-up an additional year .


Primary outcome was the incidence of malaria during the intervention period .


During the intervention , the incidence of malaria in the no chemoprevention arm was 6.95 episodes per person-year at risk .


Protective efficacy was 58 % ( 95 % CI , 45 % -67 % , p < 0.001 ) for DP , 28 % ( 95 % CI , 7 % -44 % , p = 0.01 ) for TS , and 7 % for SP ( 95 % CI , -19 % to 28 % , p = 0.57 ) .


PQ levels were below the detection limit 52 % of the time when malaria was diagnosed in the DP arm , suggesting non-adherence .


There were no differences between the study arms in the incidence of serious adverse events during the intervention and the incidence of malaria during the 1-y period after the intervention was stopped .


For preventing malaria in children living in an area of high transmission intensity , monthly DP was the most efficacious and safe , although adherence may pose a problem .


Monthly SP and daily TS may not be appropriate in areas with high transmission intensity and frequent resistance to antifolates .


www.ClinicalTrials.gov NCT00948896 Please see later in the article for the Editors ' Summary .


To investigate the electrolyte changes between 2-L polyethylene glycol with ascorbic acid 20 g ( PEG-Asc ) and 4-L PEG solutions .


From August 2012 to February 2013 , a total of 226 patients were enrolled at four tertiary hospitals .


All patients were randomly allocated to a PEG-Asc group or a 4-L PEG .


Before colonoscopy , patients completed a questionnaire to assess bowel preparation-related symptoms , satisfaction , and willingness .


Endoscopists assessed the bowel preparation using the Boston Bowel Preparation Scale ( BBPS ) .


In addition , blood tests , including serum electrolytes , serum osmolarity , and urine osmolarity were evaluated both before and after the procedure .


A total of 226 patients were analyzed .


BBPS scores were similar and the adequate bowel preparation rate ( BBPS 6 ) was not different between the two groups ( PEG-Asc vs 4-L PEG , 73.2 % vs 76.3 % , P = 0.760 ) .


Bowel preparation-related symptoms also were not different between the two groups .


The taste of PEG-Asc was better ( 41.1 % vs 16.7 % , P < 0.001 ) , and the willingness to undergo repeated bowel preparation was higher in the PEG-Asc group ( 73.2 % vs 59.3 % , P = 0.027 ) than in 4-L PEG .


There were no significant changes in serum electrolytes in either group .


In this multicenter trial , bowel preparation with PEG-Asc was better than 4-L PEG in terms of patient satisfaction , with similar degrees of bowel preparation and electrolyte changes .


The authors evaluated the effectiveness of using a patient simulator ( MARC Patient Simulator [ MARC PS ] , BlueLight analytics , Halifax , Nova Scotia , Canada ) , to instruct dental students ( DS ) on how to deliver energy optimally to a restoration from a curing light .


Five months later , the authors evaluated the retention of the instruction provided to the DS .


Toward the end of the DS ' first year of dental education , the authors evaluated the light-curing techniques of one-half of the class of first-year DS ( Group 1 ) before and after receiving instruction by means of the patient simulator .


Five months later , they retested DS in Group 1 and tested the remaining first-year DS who were then second-year DS and who had received no instruction by means of the patient simulator ( Group 2 ) .


They gave DS in Group 1 and Group 2 MARC PS instruction and retested them .


The authors also the tested fourth-year DS ( Group 3 ) and dentists ( Group 4 ) by using the MARC PS before giving any instruction by means of the MARC PS .


The results of one-way analysis of variance ( ANOVA ) showed that there were no significant differences in the ability of dentists and DS to light cure a simulated restoration before they received instruction by means of the patient simulator ( P = .26 ) .


The results of two-way ANOVA and Fisher protected least significant difference tests showed that after receiving instruction by means of the patient simulator , DS delivered significantly more energy to a simulated restoration , and this skill was retained .


There were no significant differences between DS in Group 1 and Group 2 after they had received instruction by means of the patient simulator .


The abilities of dentists and DS to light cure a simulated restoration were not significantly different .


Hands-on teaching using a patient simulator enhanced the ability of DS to use a curing light .


This skill was retained for at least five months .


The education provided to dentists and DS is insufficient to teach them how to deliver the optimum amount of energy from a curing light .


Better teaching and understanding of the importance of light curing is required .


Carers provide extended and often unrecognized support to people with cancer .


The aim of this study is to test the hypothesis that excessive carer burden is modifiable through a telephone outcall intervention that includes supportive care , information and referral to appropriate psycho-social services .


Secondary aims include estimation of changes in psychological health and quality of life .


The study will determine whether the intervention reduces unmet needs among patient dyads .


A formal economic program will also be conducted .


This study is a single-blind , multi-centre , randomized controlled trial to determine the efficacy and cost-efficacy of a telephone outcall program among carers of newly diagnosed cancer patients .


A total of 230 carer/patient dyads will be recruited into the study ; following written consent , carers will be randomly allocated to either the outcall intervention program ( n = 115 ) or to a minimal outcall / attention control service ( n = 115 ) .


Carer assessments will occur at baseline , at one and six months post-intervention .


The primary outcome is change in carer burden ; the secondary outcomes are change in carer depression , quality of life , health literacy and unmet needs .


The trial patients will be assessed at baseline and one month post-intervention to determine depression levels and unmet needs .


The economic analysis will include perspectives of both the health care sector and broader society and comprise a cost-consequences analysis where all outcomes will be compared to costs .


This study will contribute to our understanding on the potential impact of a telephone outcall program on carer burden and provide new evidence on an approach for improving the wellbeing of carers .


Pooled analysis is a powerful technique that is increasingly used to detect differences in efficacy between pharmacologic agents .


Some studies have compared the efficacy and tolerability of citalopram and escitalopram , with contradictory results .


The aim of this study was to compare the efficacy and tolerability of citalopram and escitalopram in the treatment of major depressive disorder ( MDD ) using pooled analyses .


Data from 3 randomized , double-blind studies that compared citalopram ( 20 to 40 mg/d ) and escitalopram ( 10 to 20 mg/d ) were pooled and analyzed .


The primary efficacy parameter was change from baseline in the 17-item Hamilton Rating Scale for Depression ( HAM-D-17 ) total score .


Efficacy assessments were made at weeks 0 ( baseline ) , 1 , 2 , 4 , and 6 .


Based on the mean change from baseline in the HAM-D-17 at weeks 1 , 2 , 4 , and 6 , the efficacy of citalopram , 20 to 40 mg/d , was equivalent to escitalopram , 10 to 20 mg/d ( P > .05 ) .


Similar results were seen for severely depressed patients , with a mean treatment difference of 13.9 ( SE = 7.6 ) vs 15.9 ( SE = 7.5 ) .


Response and remission rates at week 6 were similar ( response , 72.4 % for citalopram , compared with 73.5 % for escitalopram ; remission , 52.6 % vs 54.5 % , respectively ) .


The pooled analysis showed that over a 6-week treatment period , citalopram , 20 to 40 mg/d , is equivalent to escitalopram , 10 to 20 mg/d , in both efficacy and tolerability .


This study was done to compare percutaneous laser ablation ( PLA ) and radiofrequency thermoablation ( RFA ) for the treatment of hepatocellular carcinoma ( HCC ) 4 cm , in patients with liver cirrhosis .


Thirty patients with single HCC 4 cm in diameter were randomly assigned to one of two treatments : 15 patients were treated with PLA , using a multifibre system connected to a neodymium yttrium-aluminium-garnet laser source ; 15 patients were treated with RFA , using an expandable needle electrode .


Patients were followed up for up to 12 months .


A complete response was obtained in 87 % lesions treated with PLA and in 93 % lesions treated with RFA ( p = ns ) .


The overall local recurrence-free survival rates at 3 , 6 and 12 months were comparable .


However , a higher rate of recurrence was observed in the PLA group for lesions 21 mm ( p = 0.0081 ) .


A postablation syndrome was documented in 13 patients ( 1 PLA ; 12 RFA ) .


Tumour necrosis factor - was significantly higher in the RFA group ( p < 0.05 ) .


RFA is more effective in the treatment of HCC compared to PLA for lesions 21 mm .


However , PLA should be considered a viable treatment option for HCC 20 mm , in view of the lower incidence of complications .


Although the benefit of reducing blood pressure for primary and secondary prevention of stroke has been established , the effect of antihypertensive treatment in patients with acute ischemic stroke is uncertain .


To evaluate whether immediate blood pressure reduction in patients with acute ischemic stroke would reduce death and major disability at 14 days or hospital discharge .


The China Antihypertensive Trial in Acute Ischemic Stroke , a single-blind , blinded end-points randomized clinical trial , conducted among 4071 patients with nonthrombolysed ischemic stroke within 48 hours of onset and elevated systolic blood pressure .


Patients were recruited from 26 hospitals across China between August 2009 and May 2013 .


Patients ( n = 2038 ) were randomly assigned to receive antihypertensive treatment ( aimed at lowering systolic blood pressure by 10 % to 25 % within the first 24 hours after randomization , achieving blood pressure less than 140/90 mm Hg within 7 days , and maintaining this level during hospitalization ) or to discontinue all antihypertensive medications ( control ) during hospitalization ( n = 2033 ) .


Primary outcome was a combination of death and major disability ( modified Rankin Scale score 3 ) at 14 days or hospital discharge .


Mean systolic blood pressure was reduced from 166.7 mm Hg to 144.7 mm Hg ( -12.7 % ) within 24 hours in the antihypertensive treatment group and from 165.6 mm Hg to 152.9 mm Hg ( -7.2 % ) in the control group within 24 hours after randomization ( difference , -5.5 % [ 95 % CI , -4.9 to -6.1 % ] ; absolute difference , -9.1 mm Hg [ 95 % CI , -10.2 to -8.1 ] ; P < .001 ) .


Mean systolic blood pressure was 137.3 mm Hg in the antihypertensive treatment group and 146.5 mm Hg in the control group at day 7 after randomization ( difference , -9.3 mm Hg [ 95 % CI , -10.1 to -8.4 ] ; P < .001 ) .


The primary outcome did not differ between treatment groups ( 683 events [ antihypertensive treatment ] vs 681 events [ control ] ; odds ratio , 1.00 [ 95 % CI , 0.88 to 1.14 ] ; P = .98 ) at 14 days or hospital discharge .


The secondary composite outcome of death and major disability at 3-month posttreatment follow-up did not differ between treatment groups ( 500 events [ antihypertensive treatment ] vs 502 events [ control ] ; odds ratio , 0.99 [ 95 % CI , 0.86 to 1.15 ] ; P = .93 ) .