Participants in Treatment group also reported higher satisfaction with treatment compared with those in Control group .


Brief CaCBT can be effective in improving depressive symptoms , when compared with treatment as usual .


This is the first report of a trial of Culturally adapted CBT from South Asia and further studies are needed to generalise these findings .


Interactive voice response systems integrated with electronic health records have the potential to improve primary care by engaging parents outside clinical settings via spoken language .


The objective of this study was to determine whether use of an interactive voice response system , the Personal Health Partner ( PHP ) , before routine health care maintenance visits could improve the quality of primary care visits and be well accepted by parents and clinicians .


English-speaking parents of children aged 4 months to 11 years called PHP before routine visits and were randomly assigned to groups by the system at the time of the call .


Parents ' spoken responses were used to provide tailored counseling and support goal setting for the upcoming visit .


Data were transferred to the electronic health records for review during visits .


The study occurred in an urban hospital-based pediatric primary care center .


Participants were called after the visit to assess ( 1 ) comprehensiveness of screening and counseling , ( 2 ) assessment of medications and their management , and ( 3 ) parent and clinician satisfaction .


PHP was able to identify and counsel in multiple areas .


A total of 9.7 % of parents responded to the mailed invitation .


Intervention parents were more likely to report discussing important issues such as depression ( 42.6 % vs 25.4 % ; P < .01 ) and prescription medication use ( 85.7 % vs 72.6 % ; P = .04 ) and to report being better prepared for visits .


One hundred percent of clinicians reported that PHP improved the quality of their care .


Systems like PHP have the potential to improve clinical screening , counseling , and medication management .


Secondary exploratory analysis of a randomized controlled trial comparing supervised exercise therapy to usual care in patients with patellofemoral pain ( PFP ) .


To explore which patients with PFP are more likely to benefit from exercise therapy .


Patellofemoral pain is a common condition for which exercise therapy is effective in reducing pain and improving function .


However , not all patients benefit from exercise therapy .


The present study explored patient characteristics that might interact with treatment effects of PFP in 131 patients treated with usual care or exercise therapy .


These characteristics were tested for interaction with treatment in a regression analysis .


The primary outcomes were function and pain on activity at a 3-month follow-up .


None of the tested variables had a significant interaction with treatment .


A positive trend was seen for females with PFP : they were more likely to report higher function scores with exercise therapy than with usual care compared to males with PFP ( = 12.1 ; 95 % confidence interval : 0.23 , 24.0 ; P = .05 ) .


A positive trend was seen for patients with a longer duration of complaints ( greater than 6 months ) ; they were more likely to report higher function scores and to have less pain on activity with exercise therapy than with usual care compared to those with a shorter duration of complaints ( = 12.3 ; 95 % confidence interval : -0.08 , 24.7 ; P = .05 and = -1.74 ; 95 % confidence interval : -3.90 , 0.43 ; P = .12 , respectively ) .


Two factors , sex and duration of complaints , may have a predictive value for response to exercise therapy at 3-month follow-up .


Due to the exploratory design of the study , future research should confirm this tendency .


Tobacco use is epidemic among persons living with HIV ( PLWH ) , and several studies have shown self-efficacy ( SE ) to be a predictor of successful cessation .


This study examined sociobehavioral correlates of SE and its predictive value for successful cessation in a group of PLWH smokers .


The study was conducted on combined patient data from 2 separate randomized controlled trials of tobacco treatment for PLWH smokers .


Both trials utilized the same SE scale at the same timepoints , and both had the same smoking cessation endpoint ( biochemically confirmed , 7-day , point prevalence abstinence at 3 months ) .


Univariate and multivariate techniques were used to analyze the merged dataset .


Baseline SE data were available for 272 subjects .


The Self-Efficacy/Temptations Scale-Long Form demonstrated good internal reliability with overall and subscale Cronbach 's alpha of .77 -.92 .


Younger age , HIV risk other than injection drug use , recent alcohol use , and higher scores for anxiety , depression , loneliness , and nicotine dependence were all significantly correlated with lower baseline SE .


Posttreatment SE was significantly predictive of successful cessation , whereas baseline SE was not .


Subjects randomized to the treatment interventions were significantly more likely to quit ( AOR = 2.99 [ 1.26-7 .01 ] , p = .01 ) , and logistic regression suggested a possible mediating effect of posttreatment SE .


SE is tightly correlated with a number of modifiable affective and behavioral factors in PLWH smokers , and measures aimed at increasing the SE to abstain in such individuals may enhance the effect of targeted tobacco treatment strategies .


In this study , we assessed the efficacy of 2 pharmacodynamically different antidepressants , citalopram ( a selective serotonin reuptake inhibitor ) and reboxetine ( a norepinephrine reuptake inhibitor ) , as adjunctive therapy to risperidone and olanzapine for the treatment of negative symptoms in schizophrenia .


We performed a 6-month , multicenter , double-blind , randomized , placebo-controlled clinical trial .


The recruitment period was from November 2008 to December 2011 .


The sample comprised 90 patients with a diagnosis of schizophrenia ( DSM-IV criteria ) who exhibited negative symptoms .


The patients were recruited from 10 centers in different cities of the Spanish State .


The primary efficacy measure was change in score on the negative subscale of the Positive and Negative Syndrome Scale ( PANSS ) between baseline and 6-month assessment .


Other efficacy measures were changes in the PANSS subscales and total score , as well as the Scale for the Assessment of Negative Symptoms ( SANS ) subscales and total score .


For statistical analysis , we employed mixed-effects models .


We did not find statistically significant differences between the placebo group and the 2 treatment groups at 6-month assessments for the PANSS total ( P = .6511 ) , any PANSS subscale ( negative [ P = .5533 ] , positive [ P = .1723 ] , or general psychopathology [ P = .2083 ] ) , or the SANS ( P = .5884 ) .


Cohen d measure showed a small effect size below the 0.5 threshold for all comparisons .


In conclusion , our results do not support adjunctive use of citalopram or reboxetine with risperidone or olanzapine for the treatment of negative symptoms in schizophrenia .


ClinicalTrials.gov identifier : NCT01300364 .


It has been found that mask style can affect the amount of continuous positive airway pressure ( CPAP ) required to reduce an apnoea/hyponoea index ( AHI ) to < 5/h on a titration study .


However , it was not previously known whether switching from one CPAP mask style to another post titration could affect the residual AHI with CPAP .


The purpose of this study was to investigate the differences in residual AHI with CPAP treatment between oronasal and nasal masks .


Twenty-one subjects ( age mean ( M ) = 62.9 , body mass index ( BMI ) M = 29.6 kg/m2 ) were randomised ( 14 subjects completed the protocol ) to undergo an in-laboratory CPAP titration with either a nasal mask or an oronasal mask .


Subjects were then assigned this mask for 3weeks of at-home CPAP use with the optimal treatment pressure determined on the laboratory study ( CPAP M = 8.4 cm of H2O ) .


At the end of this 3-week period , data were collected from the CPAP machine and the subject was given the other mask to use with the same CPAP settings for the next 3weeks at home ( if the nasal mask was given initially , the oronasal one was given later and vice versa ) .


On completion of the second 3-week period , data on residual AHI were again collected and compared with the first 3-week period on CPAP .


A Wilcoxon Signed-Rank Test ( two-tailed ) revealed that residual AHI with CPAP treatment was significantly higher with the oronasal compared with the nasal mask ( z = -3.296 , p < 0.001 ) .


All 14 subjects had a higher residual AHI with the oronasal versus nasal mask , and 50 % of the subjects had a residual AHI > 10/h in the oronasal mask condition , even though all of these subjects were titrated to an AHI of < 5/h in the laboratory .


A higher residual AHI was seen in all patients with the use of an oronasal mask compared with a nasal mask .


Switching to an oronasal mask post titration results in an increase in residual AHI with CPAP treatment , and pressure adjustment may be warranted .


To report on risk factors for severe events ( hospitalisation or infant death ) within the first half of infancy amongst HIV-unexposed infants in South Africa .


South African data from the multisite community-based cluster-randomised trial PROMISE EBF promoting exclusive breastfeeding in three sub-Saharan countries from 2006 to 2008 were used .


The South African sites were Paarl in the Western Cape Province , and Umlazi and Rietvlei in KwaZulu-Natal .


This analysis included 964 HIV-negative mother-infant pairs .


Data on severe events and infant feeding practices were collected at 3 , 6 , 12 and 24 weeks post-partum .


We used a stratified extended Cox model to examine the association between the time to the severe event and covariates including birthweight , with breastfeeding status as a time-dependent covariate .


Seventy infants ( 7 % ) experienced a severe event .


The median age at first hospitalisation was 8 weeks , and the two main reasons for hospitalisation were cough and difficult breathing followed by diarrhoea .


Stopping breastfeeding before 6 months ( HR 2.4 ; 95 % CI 1.2-5 .1 ) and low birthweight ( HR 2.4 ; 95 % CI 1.3-4 .3 ) were found to increase the risk of a severe event , whilst maternal completion of high school education was protective ( HR 0.3 ; 95 % CI 0.1-0 .7 ) .


A strengthened primary healthcare system incorporating promotion of breastfeeding and appropriate caring practices for low birthweight infants ( such as kangaroo mother care ) are critical .


Given the leading reasons for hospitalisation , early administration of oral rehydration therapy and treatment of suspected pneumonia are key interventions needed to prevent hospitalisation in young infants .


As histopathologic assessment is subject to sampling error , some institutions ` preorder ' deeper sections on some or all cases ( hereafter referred to as prospective deeper sections ) , while others order additional sections only when needed ( hereafter referred to as retrospective deeper sections ) .


We investigated how often additional sections changed a diagnosis and/or clinical management .


Given the recent decrease in reimbursement for CPT-code 88305 , we also considered the financial implications of ordering additional sections .


Cases ( n = 204 ) were assigned a preliminary diagnosis , based on review of the initial slide , and a final diagnosis , after reviewing additional sections .


Cases with discordant diagnoses were assessed by two dermatologists , who indicated whether the change in diagnosis altered clinical management .


Expenses were estimated for three scenarios : ( a ) no additional sections , ( b ) prospective deeper sections and ( c ) retrospective deeper sections .


Diagnoses were modified in 9 % of cases , which changed clinical management in 56 % of these cases .


Lesions obtained by punch-biopsy and inflammatory lesions were disproportionately overrepresented amongst cases with changed diagnoses ( p < 0.001 , p = 0.12 , respectively ) .


The cost of prospective deeper sections and retrospective deeper sections represented a 56 % and 115 % increase over base costs , respectively .


Labor costs , particularly the cost of dermatopathologist evaluation , were the most significant cost-drivers .


While additional sections improve diagnostic accuracy , they delay turn-around-time and increase expenditures .


In our practice , prospective deeper sections are cost effective , however , this may vary by institution .


To evaluate the role of 2 different -1 blockers and 1 phosphodiesterase-5 inhibitor as medical expulsive therapy for distal ureteric calculi .


Between January 2011 and December 2012 , 285 patients presenting with distal ureteric stones of size 5-10 mm were on consent randomly assigned to 1 of 3 outpatient treatment arms : tamsulosin ( group A ) , silodosin ( group B ) , and tadalafil ( group C ) .


Therapy was given for a maximum of 4 weeks .


Stone expulsion rate , time to stone expulsion , analgesic use , number of hospital visits for pain , follow-up , and endoscopic treatment and adverse effects of drugs were noted .


All 3 groups were compared for normally distributed data by the analysis of variance , Bonferroni or Kruskal-Wallis test , and Mann-Whitney U test , as required .


All the classified and categorical data were analyzed for all 3 groups by using the chi-square test .


There was a statistically significant expulsion rate of 83.3 % in group B compared with 64.4 % and 66.7 % in groups A and C , respectively , with lower time of stone expulsion ( P value = .006 and P value = .016 , respectively ) .


Statistically significant differences were noted in colicky episodes and analgesic requirement in group B than groups A and C.


There was no serious adverse event .


Medical expulsive therapy for the distal ureteric stones using tamsulosin , silodosin , and tadalafil is safe , efficacious , and well tolerated .


The result of this pilot study showed that silodosin increases ureteric stone expulsion quite significantly along with better control of pain with significantly lesser analgesic requirement .


Some cigarette smokers may not be ready to quit immediately but may be willing to reduce cigarette consumption with the goal of quitting .


To determine the efficacy and safety of varenicline for increasing smoking abstinence rates through smoking reduction .


Randomized , double-blind , placebo-controlled , multinational clinical trial with a 24-week treatment period and 28-week follow-up conducted between July 2011 and July 2013 at 61 centers in 10 countries .


The 1510 participants were cigarette smokers who were not willing or able to quit smoking within the next month but willing to reduce smoking and make a quit attempt within the next 3 months .


Participants were recruited through advertising .


Twenty-four weeks of varenicline titrated to 1 mg twice daily or placebo with a reduction target of 50 % or more in number of cigarettes smoked by 4 weeks , 75 % or more by 8 weeks , and a quit attempt by 12 weeks .


Primary efficacy end point was carbon monoxide-confirmed self-reported abstinence during weeks 15 through 24 .


Secondary outcomes were carbon monoxide-confirmed self-reported abstinence for weeks 21 through 24 and weeks 21 through 52 .


The varenicline group ( n = 760 ) had significantly higher continuous abstinence rates during weeks 15 through 24 vs the placebo group ( n = 750 ) ( 32.1 % for the varenicline group vs 6.9 % for the placebo group ; risk difference ( RD ) , 25.2 % [ 95 % CI , 21.4 % -29.0 % ] ; relative risk ( RR ) , 4.6 [ 95 % CI , 3.5-6 .1 ] ) .


The varenicline group had significantly higher continuous abstinence rates vs the placebo group during weeks 21 through 24 ( 37.8 % for the varenicline group vs 12.5 % for the placebo group ; RD , 25.2 % [ 95 % CI , 21.1 % -29.4 % ] ; RR , 3.0 [ 95 % CI , 2.4-3 .7 ] ) and weeks 21 through 52 ( 27.0 % for the varenicline group vs 9.9 % for the placebo group ; RD , 17.1 % [ 95 % CI , 13.3 % -20.9 % ] ; RR , 2.7 [ 95 % CI , 2.1-3 .5 ] ) .


Serious adverse events occurred in 3.7 % of the varenicline group and 2.2 % of the placebo group ( P = .07 ) .


Among cigarette smokers not willing or able to quit within the next month but willing to reduce cigarette consumption and make a quit attempt at 3 months , use of varenicline for 24 weeks compared with placebo significantly increased smoking cessation rates at the end of treatment , and also at 1 year .


Varenicline offers a treatment option for smokers whose needs are not addressed by clinical guidelines recommending abrupt smoking cessation .


clinicaltrials.gov Identifier : NCT01370356 .


To investigate the application and the clinical effect of nasal endoscope in styloid process truncating operation .


Dividing 66 patients into nasal endoscope group and control group randomly , and then observe them .


Nasal endoscope group were cured with nasal endoscope during the styloid process truncating operation and the control group were treated with the routine method of intraoral path .


All the operations were executed by the same person .


Observation index included the following aspects : the length of the truncated styloid process , the operation time , intraoperative bleeding , postoperative pain and pain degree , inflammatory reaction of raw surface and rehaemorrhagia .


Compared with the control group , the length of the truncated styloid process of nasal endoscope group were longer and the operation time had no significant differences .


The intraoperative bleeding of intraoperative bleeding group were ( 85.0 + / - 35.0 ) ml and in control group were ( 95.0 + / - 40.0 ) ml .


There are no significant differences between the result .


Nasal endoscope group also had the advantages of fewer aches and less inflammatory reaction of raw surface .


Both of the team had no rehaemorrhagia .


nasal endoscope can truncate a longer styloid process in styloid process truncating operation and is effective to relieve pain , and ease inflammatory reaction , it 's a safe mini-trauma operation .


I.v. 0.9 % sodium chloride ( normal saline ) is frequently used to treat ED patients with acute alcohol intoxication despite the lack of evidence for its efficacy .


The study aims to compare treatment with i.v. normal saline and observation with observation alone in ED patients with acute alcohol intoxication .


A single-blind , randomised , controlled trial was conducted to compare a single bolus of 20 mL/kg i.v. normal saline plus observation with observation alone .


One hundred and forty-four ED patients with uncomplicated acute alcohol intoxication were included .


The study was conducted in one tertiary and one urban ED in Queensland , Australia .


Primary outcome was ED length of stay ( EDLOS ) .


Secondary outcomes were treatment time , breath alcohol levels , intoxication symptom score , level of intoxication and associated healthcare costs .


Both groups were comparable at baseline : blood alcohol content ( BAC ) was similar between treatment and control groups ( 0.20 % BAC vs 0.19 % BAC , P = 0.44 ) as were initial intoxication symptom scores ( 22.0 vs 22.3 , P = 0.90 ) .


Both groups had a similar EDLOS ( 287 min vs 274 min , P = 0.89 ; difference 13 min [ 95 % CI -37 -63 ] ) and treatment time ( 244 min vs 232 min , P = 0.94 ; difference 12 min [ 95 % CI -31 -55 ] ) .


Change of breath alcohol levels , intoxication score and level of intoxication were not significantly different between the two groups .


Patients in the treatment group had an additional healthcare cost of A$ 31.92 compared with control .


I.v. normal saline therapy added to observation alone does not decrease ED length of stay compared with observation alone .


Intoxication symptom scores and general state of intoxication were similar in both groups .


The present study suggests that either approach is reasonable , but observation alone might be preferred as it is less resource intensive .


Inhaled corticosteroids are a mainstay of therapy for persistent asthma , but suboptimal adherence with twice-daily use is widespread .


Fluticasone furoate ( FF ) is a new inhaled corticosteroid ( ICS ) suitable for once-daily dosing in asthma .


This study was performed to descriptively assess the efficacy and safety of two doses of FF , with no planned formal statistical hypothesis testing .


This was a 24-week double-blind , multicentre , parallel-group study ( NCT01431950 ) .


Patients aged 12 years with moderate-severe persistent asthma and uncontrolled on mid-high dose ICS were stratified by baseline FEV1 and randomised ( 1:1 ) to treatment with FF 100 g or 200 g once daily in the evening .


The primary endpoint was change from baseline trough FEV1 after 24 weeks ; secondary and other endpoints included peak expiratory flow ( PEF ) and rescue-free and symptom-free 24-hour periods over Weeks 1-24 , and Asthma Control Test ( ACT ) score at Week 24 .


A pre-specified subgroup analysis of patients by randomisation strata was performed for the primary and selected secondary and other endpoints .


Safety assessments included adverse events , laboratory and vital sign measurements , and change from baseline in 24-hour urinary cortisol at Week 24 .


With FF 100 g and 200 g , least squares mean trough FEV1 improved from baseline by 208 mL and 284 mL , respectively , at Week 24 ; treatment difference : 77 mL ( 95 % CI : -39 , 192 ) .


Similar improvements from baseline in rescue - and symptom-free periods , and morning and evening PEF were observed in both groups .


Patients were 42 % more likely to be well-controlled ( ACT score 20 ) with FF 200 g than with FF 100 g. Slightly more patients receiving FF 200 g vs. FF 100 g reported adverse events ( 63 % vs. 59 % ) and events deemed treatment related ( 5 % vs. < 1 % ) .


Seven serious adverse events ( FF 200 g 4 ; FF 100 g 3 ) were reported , none of which were deemed treatment related .


No clinically relevant effects of either dose on 24-hour urinary cortisol were observed .


Improvements from baseline in trough FEV1 were observed after 24 weeks of treatment with both doses of FF , with a numerically greater improvement in FEV1 observed in patients receiving FF 200 g. Secondary endpoint findings were similar between groups .


No safety concerns were identified during the study .


This study evaluated the effectiveness of a school-community program on Health-Related Quality of Life ( HRQoL ; the primary outcome ) , physical activity ( PA ) , and potential mediators of PA among adolescent girls living in low-socioeconomic rural/regional settings .


The study was a cluster-randomized controlled trial .


Twelve communities with the requisite sports clubs and facilities were paired according to relevant criteria ; one of each pair was randomly assigned to the intervention or control condition .


Eight schools per condition were randomly selected from these communities and the intervention was conducted over one school year ( 2011 ) .


Female students in grades 7-9 in intervention schools participated in two 6-session PA units - a sport unit ( football or tennis ) and a recreational unit ( leisure centre-based ) .


These were incorporated into physical education ( PE ) curriculum and linked to PA opportunities for participation outside school .


Students were surveyed at baseline and endpoint , self-reporting impact on primary and secondary outcome measures ( HRQoL , PA ) and PA mediators ( e.g. self-efficacy ) .


Linear mixed models for two-group ( intervention , control ) and three-group ( completers , non-completers , control ) analyses were conducted with baseline value , age and BMI as covariates , group as a fixed effect and school as random cluster effect .


Participants completing baseline and endpoint measures included : 358 intervention ( baseline response rate 33.7 % , retention rate 61.3 % ) and 256 control ( 14.1 % and 84.0 % ) .


Adjustment for age and BMI made no substantive difference to outcomes , and there were no cluster effects .


For HRQoL , after adjustment for baseline scores , the intervention group showed significantly higher scores on all three PedsQL scores ( physical functioning : MSE = 83.90.7 , p = .005 ; psychosocial : 79.90.8 , p = .001 ; total score : 81.30.7 , p = .001 ) than the control group ( 80.90.8 ; 76.10.9 and 77.80.8 ) .


The three-group analysis found intervention non-completers had significantly higher PedsQL scores ( 84.00.8 , p = .021 ; 80.40.9 , p = .003 ; 81.70.8 , p = .002 ;) than controls ( 80.90.8 , 76.10.9 and 77.80.8 ) .


There were no significant differences for any PA measure .


Intervention completers had significantly higher scores than non-completers and controls for some mediator variables ( e.g. self-efficacy , behavioural control ) .


Positive outcomes were achieved from a modest school-community linked intervention .


The school component contributed to maintaining HRQoL ; students who completed the community component derived a range of intra-personal and inter-personal benefits .


ACTRN12614000446662 .


April 30th 2014 .


This study examined the effects of moderate renal impairment on the pharmacokinetics and pharmacodynamics of canagliflozin in Japanese patients with type 2 diabetes mellitus .


Japanese patients with stable type 2 diabetes ( 12 with moderate renal impairment and 12 with normal renal function or mild renal impairment ) were eligible .


This was an open-label , randomized , two-way crossover , two-sequence , single-dose study performed at a single center in Japan .


The subjects were hospitalized for the pharmacodynamic/pharmacokinetic evaluations .


Twenty-four patients received a single dose each of canagliflozin 100 and 200 mg before breakfast in a crossover manner with a 14-day washout between doses .


The main outcome measures were pharmacokinetics of canagliflozin and its main metabolites ( M5 and M7 ) in plasma and urine , and change from baseline in 24-h urinary glucose excretion ( UGE24 h ) .


There was no significant effect of moderate renal impairment on the maximum canagliflozin concentration .


The ratios of least square means ( 90 % confidence intervals [ CIs ] ) of moderate renal impairment relative to normal renal function or mild renal impairment were 0.982 ( 0.821-1 .173 ) and 0.989 ( 0.827-1 .182 ) for the 100 and 200 mg doses , respectively .


The canagliflozin area under the plasma concentration-time curve was greater in those with moderate renal impairment than in those without , after both canagliflozin doses ( ratio of least square means [ 90 % CI ] 1.258 [ 1.061-1 .490 ] and 1.216 [ 1.026-1 .441 ] ) .


UGE24 h increased after administration of both doses , but in patients with moderate renal impairment , the increase was approximately 70 % of that in patients with normal renal function or mild renal impairment .


The incidence of adverse events was low and no patient developed hypoglycemia .


The pharmacokinetics of canagliflozin are affected by renal function , with slight decreases in renal clearance observed .


No effect of renal impairment on the maximum concentration was observed .


Renal impairment reduced the ability of canagliflozin to promote urinary glucose excretion .


This study evaluated the efficacy and safety of canagliflozin , a sodium glucose co-transporter 2 inhibitor , in patients with type 2 diabetes mellitus ( T2DM ) and within a subset of Stage 3 chronic kidney disease ( CKD ; estimated glomerular filtration rate [ eGFR ] 30 and < 50 ml/min/1 .73 m ( 2 ) ) .


In this 52-week , randomized , double-blind , placebo-controlled study , patients ( N = 269 ; mean eGFR , 39.4 ml/min/1 .73 m ( 2 ) ) received canagliflozin 100 or 300 mg and placebo once daily .


Efficacy endpoints included changes in glycated haemoglobin ( HbA1c ) , fasting plasma glucose ( FPG ) , body weight and systolic blood pressure ( BP ) ; adverse events ( AEs ) were also recorded .


At week 52 , canagliflozin 100 and 300 mg reduced HbA1c compared with placebo ( -0.19 , -0.33 and 0.07 % , respectively ) ; placebo-subtracted differences ( 95 % confidence interval ) were -0.27 % ( -0.53 , 0.001 ) and -0.41 % ( -0.68 , -0.14 ) .


Canagliflozin also lowered FPG , body weight and BP versus placebo .


Overall AE incidence was 85.6 , 80.9 , and 86.7 % with canagliflozin 100 and 300 mg and placebo , respectively .


Osmotic diuresis-related AEs were more common with both canagliflozin doses , and incidences of urinary tract infections and volume depletion-related AEs were higher with canagliflozin 300 mg versus placebo .


Decreases in eGFR ( -2.1 , -4.0 and -1.6 ml/min/1 .73 m ( 2 ) ) were seen with canagliflozin 100 and 300 mg compared with placebo .


Canagliflozin 100 and 300 mg provided median percent reductions in urine albumin to creatinine ratio versus placebo ( -16.4 , -28.0 and 19.7 % ) .


Canagliflozin improved glycaemic control and was generally well tolerated in patients with T2DM and within a subset of Stage 3 CKD over 52 weeks .


To evaluate the use and effectiveness of two `` in-home '' strategies for delivering diabetes prevention programming using cable television .


An individually randomized , two-arm intervention trial including adults with diabetes risk factors living in two US cities .


Interventions involved a 16-session lifestyle intervention delivered via `` video-on-demand '' cable television , offered alone versus in combination with web-based lifestyle support tools .


Repeated measures longitudinal linear regression with imputation of missing observations was used to compare changes in body weight .


A total of 306 individuals were randomized and offered the interventions .


After 5 months , 265 ( 87 % ) participants viewed at least 1 , and 110 ( 36 % ) viewed 9 of the video episodes .


A total of 262 ( 86 % ) participants completed a 5-month weight measurement .


In intention-to-treat analysis with imputation of missing observations , mean weight loss at 5 months for both treatment groups combined was 3.3 % ( 95 % CI 0.7-5 .0 % ) , regardless of intervention participation ( with no differences between randomized groups ( P = 0.19 ) ) , and was 4.9 % ( 95 % CI 2.1-6 .5 % ) for participants who viewed 9 episodes .


In-home delivery of evidence-based diabetes prevention programming in a reality television format , offered with or without online behavioral support tools , can achieve modest weight losses consistent with past implementation studies of face-to-face programs using similar content .


To study the effect of residual myrosinase ( MYR ) activity in differently processed broccoli on sulforaphane ( SR ) and iberin ( IB ) formation , bioavailability , and excretion in human volunteers .


Five different broccoli products were obtained with similar glucoraphanin ( GR ) and glucoiberin ( GI ) content , yet different MYR activity .


Excretion of SR and IB conjugates in urine were determined in 15 participants after ingestion of the broccoli products .


A reduction of 80 % of MYR in the product did not cause differences in the total amount of SR and IB found in urine compared to the product with 100 % MYR .


Complete inactivation of MYR gave the lowest total amount of SR and IB in urine ( 10 and 19 % ) .


A residual MYR of only 2 % in the product gave an intermediate amount ( 17 and 29 % ) .


The excretion half-lives of SR and IB conjugates were comparable for all the products ( 2.5 h on average ) , although the maximum excretion peak times were clearly shorter when the residual MYR was higher ( 2.3-6 .1 h ) .


For the first time , the effect of residual MYR activity on isothiocyanate bioavailability was systematically and quantitatively studied .


Processing conditions have a large effect on the kinetics and bioavailability of isothiocyanates from broccoli .


Depression is the leading cause of early death , affecting 15 % of Americans older than 65 y and costing $ 43 billion each year .


The current mental health service system for seniors , particularly for the population hospitalized in acute inpatient psychiatric units , is fragmented because of poor funding and a shift to a transitory health care paradigm , leading to inadequate treatment modalities , questionable quality of care , and lack of research demonstrating the superiority of a particular treatment .


These issues are likely to lead to a public health crisis in the coming years .


To investigate the effectiveness of combining exercise and psychotherapy in improving acute depressive symptoms among older adults who were receiving treatment in an inpatient psychiatric unit .


Based on rolling admissions , inpatients were randomly assigned to 1 of 3 treatment groups .


The study was blinded and controlled .


This study took place in inpatient psychiatric units at the Loma Linda University 's Behavioral Medicine Center ( LLUBMC ) in Redlands , California .


Participants were 78 inpatients , aged 50-89 y.


Participants in the simultaneous exercise and psychotherapy ( STEP ) group ( n = 26 ) took part in exercise and received psychotherapy for 30 min per session , whereas those in the TALK group ( n = 26 ) received individual psychotherapy for 30 min per session .


Participants in the control group ( n = 26 ) served as a comparison group , receiving standard therapy .


The effects of the interventions were determined by assessing differences from baseline to postintervention in the symptomatology of all 3 groups .


The research team also administered the Behavioral and Symptom Identification Scale ( BASIS-32 ) and the Geriatric Depression Scale ( GDS ) pre - and postintervention .


At posttest , the STEP group ( M = 4.24 , SE = 0.62 ) had a better response than the TALK group ( M = 11.34 , SE = 0.62 , P < .001 ) , which in turn showed greater improvement than the control group ( M = 14.84 , SE = 0.62 , P < .001 ) .


Overall , these results indicate that patients ' posttreatment depression scores were significantly lower in those receiving the STEP treatment compared with those receiving individual psychotherapy only or standard care .


A short-term exercise program consisting of 30 min of walking in conjunction with individual psychotherapy was an effective intervention for depression among older adults in inpatient psychiatric units .


High levels of physical inactivity are linked to several chronic diseases including coronary heart disease , type-2 diabetes , obesity , some cancers and poor mental health .


Encouraging people to be more active has proven difficult .


One way to incorporate physical activity into the daily routine is through the journey to and from work .


Although behaviour change techniques ( BCTs ) are considered valuable in promoting behaviour change , there is very little in the published literature about the views and experiences of those encouraged to use them .


The Walk to Work study was a feasibility study incorporating an exploratory cluster randomised controlled trial .


The 10-week intervention involved training workplace-based Walk to Work promoters ( volunteers or nominated by participating employers ) to encourage colleagues to increase walking during their daily commute .


The intervention used nine specific BCTs : Intention formation , barrier identification , specific goal setting , instruction , general encouragement , self-monitoring of behaviour social support , review of behavioural goals and relapse prevention .


Digitally recorded interviews were undertaken with 22 employees , eight of whom were Walk to Work promoters to understand their views and experiences of using these techniques .


The Framework method of data management and constant comparison were used to analyse the data and identify key themes .


For each individual BCT , there appeared to be people who found it useful in helping them to increase walking to work and others who did not .


Following training , the Walk to Work promoters varied in the extent to which they were able to fulfil their role : additional support and encouragement during the 10-week intervention may be required for the promoters to maintain motivation .


Wider contextual ( economic climate , unprecedented wet weather ) and organisational ( workload , car parking facilities ) issues were identified that influenced the delivery of , and response to , the intervention .


Walk to work interventions employing BCTs should include sufficient techniques to enable participants to choose a ` package ' to suit their needs .


Additional support at organisational level should also be encouraged , and consideration given to wider contextual factors that impinge on the delivery of , and response to , the intervention .


ISRCTN72882329 .


Given the diversity of visual acuity tests being employed across the world , we compared two frequently applied tests : ETDRS charts and an eight-orientation projected Landolt C test in accordance with ISO 8596 and DIN 58220 part 3 .


The goals of the investigation were to determine ( i ) test agreement and ( ii ) test-retest reliability , to assess ( iii ) test durations , and ( iv ) the acceptance of the tests by the examinees as well as the subjects ' coping with the tests as rated by the examiner .


Seventy-five adult subjects with a visual acuity of 0.2 ( 4/20 ) were included in one of the following groups : normal , media opacity , maculopathy , optic neuropathy , ( post ) chiasmal lesion , or amblyopia .


Visual acuity testing was carried out monocularly , in balanced randomized order and in two runs for each test on the same eye , applying forced choice .


Agreement : Within each group , all tests were performed similarly , within 0.048 logMAR .


Reliability : Across all subject groups , with a probability of 95 % , test-retest differences were < 0.18 logMAR for both ETDRS and Landolt tests .


The Landolt test lasted , on average , 1.8 times longer than ETDRS charts ( p < 0.001 ) .


Acceptance : Examinees preferred the ETDRS test ( p < 0.001 ) , the examiner on average had no preference .


The Landolt C test and the ETDRS test yielded comparable results in visual acuity and test-retest reliability in all disease groups .


The ETDRS test was usually faster and more accepted by both examiners and examinees than the Landolt test .


Depression is common after a cardiac event , yet there remain few approaches to management that are both effective and scalable .


We aimed to evaluate the 6-month efficacy and feasibility of a tele-health program ( MoodCare ) that integrates depression management into a cardiovascular disease risk reduction program for acute coronary syndrome patients with low mood .


A two-arm , parallel , randomized design was used comprising 121 patients admitted to one of six hospitals for acute coronary syndrome .


Significant treatment effects were observed for Patient Health Questionnaire 9 ( PHQ9 ) depression ( mean difference [ change ] = -1.8 ; p = 0.025 ; effect size : d = 0.36 ) for the overall sample , when compared with usual medical care .


Results were more pronounced effects for those with a history of depression ( mean difference [ change ] = -2.7 ; p = 0.043 ; effect size : d = 0.65 ) .


MoodCare was effective for improving depression in acute coronary syndrome patients , producing effect sizes exceeding those of some face-to-face psychotherapeutic interventions and pharmacotherapy .


ACTRN1260900038623 . )


Heart failure is one of the most common und costly chronic diseases .


Patient education is an important part of heart failure therapy .


Rehabilitation aims to improve self-management abilities and the course of the disease .


A structured heart failure education program was established to create knowledge about the disease and to implement a disease friendly behavior .


The effectiveness was tested in a randomized controlled design .


Patients were cluster randomized - assigned to an intervention group or a control group at the beginning of a rehabilitation .


Both received a rehabilitation specifically geared to heart-failure-patients .


The intervention group received additionally the education program , the control group a single lecture on the disease .


At the end of rehabilitation and 6 months later the knowledge and integrity of the recommended self-tests have been checked .


In addition the disease severity and pharmacotherapy were determined .


Both groups showed improvements in disease status .


Participants of the education program had a sustained higher knowledge , were better adjusted to medication after 6 months and documented their self-tests more frequently .


Regardless to the education intervention an improvement of the disease status occurs during cardiac rehabilitation .


The effective single components are still unclear .


The evaluated education program leads specifically to an improved disease-related knowledge and improved self-management skills .


Due to these results it seems useful to include cardiac rehabilitation in heart failure disease-management programs - a specific heart failure education program should be integrated .


To propose and evaluate an automatic method of extracting parenchyma from a manually delineated whole liver for the R2 * measurement of iron load .


In all , 108 transfusion-dependent patients with a wide range of hepatic iron content were scanned with a multiecho gradient-echo sequence .


The R2 * was measured by fitting the average signal of liver parenchyma , extracted by the proposed semiautomatic parenchyma extraction ( SAPE ) , traditional manually delineated multiple regions-of-interest ( mROIs ) , and T2 * thresholding methods to the noise-corrected monoexponential model .


The R2 * measurement accuracy of the SAPE method was evaluated through simulation ; the intra - and interobserver reproducibility of SAPE , mROI , and T2 * thresholding were assessed from the in vivo data using coefficient of variation ( CoV ) .


In the simulation , the mean absolute percentage error of R2 * measurement using SAPE was 0.23 % ( range 0.01 % -1.09 % ) .


In vivo study , the CoVs of intra - and interobserver reproducibility were 0.83 % , 1.39 % for SAPE , 3.63 % , 6.28 % for mROI , and 1.62 % , 2.66 % for T2 * thresholding , respectively .


The SAPE method provides an accurate and reliable approach to assessing the overall hepatic iron content .


The improved magnetic resonance imaging ( MRI ) R2 * reproducibility using the SAPE method may lead to more accurate tissue characterization and increased diagnostic confidence .


The objective of this study was to assess the ability of a dentifrice containing 8 % arginine and calcium carbonate ( Pro-Argin ' Technology ) , and 1450 ppm fluoride as sodium monofluorophosphate ( MFP ) to prevent enamel loss from an erosive acid challenge in comparison to a silica-based dentifrice with 1450 ppm fluoride as MFP using an intra-oral erosion model .


The intra-oral clinical study used a double blind , two-treatment , crossover design .


A palatal retainer was used to expose the enamel specimens to the oral environment during the five-day treatment period .


The retainer was designed to house three partially demineralized bovine enamel samples .


The study population was composed of 24 adults , ages 18 to 70 years .


The study consisted of two treatment periods , with a washout period lasting seven ( + / - three ) days preceding each treatment phase .


A silica-based dentifrice without fluoride was used during the washout period .


The Test Dentifrice used in this study contained 8 % arginine and calcium carbonate ( Pro-Argin Technology ) , and 1450 ppm fluoride as sodium monofluorophosphate ( MFP ) .


The Control Dentifrice was silica-based and contained 1450 ppm fluoride as MFP .


The treatment period lasted five days , during which the panelists wore the retainer 24 hours a day ( except during meals and the ex vivo acid challenges ) and brushed with their assigned product while wearing the retainer .


The panelists brushed once in the morning and once in the evening each day for one minute , followed by a one-minute swish with the slurry and a rinse with 15 ml of water .


The panelists brushed only their teeth and not the specimens directly .


There were four ex vivo challenges with 1 % citric acid dispersed throughout the day : two in the morning , one in the afternoon , and one in the evening .


Mineral loss was monitored by a quantitative light fluorescence ( QLF ) technique .


Twenty-three of 24 subjects successfully completed the study .


The one subject who did not complete the study did so for reasons unrelated to the study or products used .


The average percent mineral loss for the Test Dentifrice and Control Dentifrice was 9.74 + / - 13.23 and 18.36 + / - 14.14 , respectively .


The statistical analysis showed that the observed product differences were statistically significant ( p < 0.001 ) .


The Test Dentifrice with 8 % arginine , calcium carbonate , and 1450 ppm fluoride as MFP provided significantly better protection against erosive challenges in comparison to the Control Dentifrice with 1450 ppm fluoride as MFP .


An attentional bias for negative information plays an important role in the development and maintenance of ( social ) anxiety and depression , which are highly prevalent in adolescence .


Attention Bias Modification ( ABM ) might be an interesting tool in the prevention of emotional disorders .


The current study investigated whether visual search ABM might affect attentional bias and emotional functioning in adolescents .


A visual search task was used as a training paradigm ; participants ( n = 16 adolescents , aged 13-16 ) had to repeatedly identify the only smiling face in a 4 4 matrix of negative emotional faces , while participants in the control condition ( n = 16 ) were randomly allocated to one of three placebo training versions .


An assessment version of the task was developed to directly test whether attentional bias changed due to the training .


Self-reported anxiety and depressive symptoms and self-esteem were measured pre - and post-training .


After two sessions of training , the ABM group showed a significant decrease in attentional bias for negative information and self-reported social phobia , while the control group did not .


There were no effects of training on depressive mood or self-esteem .


No correlation between attentional bias and social phobia was found , which raises questions about the validity of the attentional bias assessment task .


Also , the small sample size precludes strong conclusions .


Visual search ABM might be beneficial in changing attentional bias and social phobia in adolescents , but further research with larger sample sizes and longer follow-up is needed .


To evaluate the effect of early oral stimulation before the introduction of oral feeding , over the duration of concomitant tube feeding ( `` transition period '' ) , the length of hospital stay and the breastfeeding rates upon discharge in preterm infants .


Preterm infants born between 26 and 33 weeks gestational age ( n = 86 ) , were randomized into an intervention and control group .


Infants in the intervention group received an oral stimulation program consisting in stimulation of the oral structures for 15 min at least for 10 days , before introduction of oral feeding .


Oral feeding was introduced at 34 weeks GA in both groups .


Breastfeeding rates upon discharge were significantly higher in the intervention than in the control group ( 70 % versus 45.6 % , p = 0.02 ) .


There was no statistical difference between the two groups in terms of the length of the transition period or the length of the hospital stay .


The need for prolonged CPAP support ( HR = 0.937 , p = 0.030 ) and small size for gestational age at birth ( HR = 0.338 , p = 0.016 ) were shown to be risk factors for a prolonged transition period .


A pre-feeding oral stimulation program improves breastfeeding rates in preterm infants .


The study results suggest that oral stimulation , as used in our specific population , does not shorten the transition period to full oral feeding neither the length of hospital stay .


We sought to examine the short - and long-term outcomes of patients who developed contrast-induced acute kidney injury ( CI-AKI ; defined as an increase in serum creatinine of 0.5 mg/dL or a 25 % relative rise within 48 h after contrast exposure ) from the large-scale HORIZONS-AMI trial .


Multivariable analyses were used to identify predictors of CI-AKI , as well predictors of the primary and secondary endpoints .


The incidence of CI-AKI in this cohort of ST-segment elevation myocardial infarction ( STEMI ) patients was 16.1 % ( 479/2968 ) .


Predictors of CI-AKI were contrast volume , white blood cell count , left anterior descending infarct-related artery , age , anaemia , creatinine clearance < 60 mL/min , and history of congestive heart failure .


Patients with CI-AKI had higher rates of net adverse clinical events [ NACE ; a combination of major bleeding or composite major adverse cardiac events ( MACE ; consisting of death , reinfarction , target vessel revascularization for ischaemia , or stroke ) ] at 30 days ( 22.0 vs. 9.3 % ; P < 0.0001 ) and 3 years ( 40.3 vs. 24.6 % ; P < 0.0001 ) .


They also had higher rates of mortality at 30 days ( 8.0 vs. 0.9 % ; P < 0.0001 ) and 3 years ( 16.2 vs. 4.5 % ; P < 0.0001 ) .


Multivariable analysis confirmed CI-AKI as an independent predictor of NACE [ hazard ratio ( [ HR ) , 1.53 ; 95 % confidence interval ( CI ) , 1.23-1 .90 ; P = 0.0001 ] , MACE ( HR , 1.56 ; 95 % CI , 1.23-1 .98 ; P = 0.0002 ) , non-coronary artery bypass grafting major bleeding ( HR , 2.07 ; 95 % CI , 1.57-2 .73 ; P < 0.0001 ) , and mortality ( HR , 1.80 ; 95 % CI , 1.19-2 .73 ; P = 0.005 ) at 3-year follow-up .


Contrast-induced acute kidney injury is associated with poor short - and long-term outcomes after primary percutaneous coronary intervention in STEMI .


We investigated whether nebulization of budesonide via a NasoNeb device would treat perennial allergic rhinitis .


We performed a parallel , randomized , double-blind , placebo-controlled , pilot study in subjects ( n = 40 ) with perennial allergic rhinitis .


After recording baseline symptoms , subjects were randomized to budesonide respules ( 0.25 mg ) or an equivalent placebo for 26 days .


Nasal peak inspiratory flow ( NPIF ) and nasal symptoms ( graded on a 03 scale ) were recorded by the subjects twice daily .


Rhinoconjunctivitis quality of life ( RQOL ) as well as nasal volume , measured by acoustic rhinometry , was obtained at baseline , after 2 weeks , and at the end of treatment .


The average change from baseline in symptoms over the treatment period was greater for the group on budesonide ( 3.33 ) compared to placebo ( 1.98 ) ( p = 0.45 ) .


When the average change from baseline over the treatment period was compared between the groups , budesonide resulted in higher NPIF ( 36.4 L/min ) than placebo ( 18.7 L/min ) , p = 0.094 .


QOL improved in both groups compared to baseline with no significant difference between the groups .


Although acoustic rhinometry indicated a larger volume in the group treated with budesonide on the last trial visit , the differences between the groups were not significant when accounting for the baseline values .


Compared to placebo , administration of nebulized budesonide in subjects with perennial allergic rhinitis resulted in improvements in symptoms and objective measures of nasal congestion which approached but did not achieve statistical significance .


A higher dose of active agent , a less effective placebo and a larger number of subjects might have improved statistical significance .


Randomized , controlled , crossover trial .


To examine the effects of elastic therapeutic taping ( ETT ) applied to the lumbar paraspinal region on back muscle endurance ( BME ) compared to no tape or a rigid therapeutic taping ( RTT ) procedure in individuals with nonspecific low back pain .


Elastic therapeutic taping is an increasingly popular intervention for clinicians who treat patients with low back pain .


However , no studies have investigated the effect of ETT on back extensor muscle performance in a symptomatic population .


We measured BME in 16 patients ( mean SD age , 44.8 10.4 years ; 44 % female ) with nonspecific low back pain .


Back muscle endurance was measured using the Biering-Srensen test under 3 different conditions : ETT , no tape , and RTT .


For the ETT condition , the tape was applied over the paraspinal muscles according to the Kinesio Tex taping protocol .


The RTT condition consisted of the same tape configuration but using nonelastic athletic tape .


All participants received each testing condition in random order , with 1 to 3 days between each condition .


Differences in BME between the 3 testing conditions were explored with repeated-measures analyses of variance .


There were no differences in BME between ETT and RTT , or between the RTT and no-tape conditions .


The difference in BME between the ETT and no-tape conditions was statistically significant ( mean difference , 20.7 seconds ; 95 % confidence interval : 6.8 , 34.5 ; P = .006 ) but within the threshold of measurement error .


Back muscle endurance was higher with ETT applied over the paraspinal musculature when compared to a no-tape condition .


However , the magnitude of difference did not exceed measurement error .


There was no difference in BME when using elastic or rigid therapeutic tape .


Studies have shown a mismatch between published cancer screening and genetic counseling referral recommendations and physician-reported screening and referral practices .


Inaccurate cancer risk assessment is one potential cause of this mismatch .


To assess U.S. physicians ' ability to accurately determine a woman 's colon and ovarian cancer risk level .


Cross-sectional survey of U.S. family physicians , general internists , and obstetrician-gynecologists .


A twelve-page questionnaire with a vignette of a woman 's annual examination included a question about the patient 's level of colon and ovarian cancer risk .


The final study sample included 1,555 physicians weighted to represent practicing U.S. physicians nationally .


Accuracy of physicians ' ovarian and colon cancer risk assessments .


Overall , most physicians accurately assessed women 's risk of ovarian ( 57.0 % , CI 54.3 , 59.6 ) and colon cancer ( 62.0 % , CI 59.4 , 64.6 ) .


However , 27.1 % ( CI 23.0 , 31.6 ) of physicians overestimated the ovarian cancer risk among women at the same risk as the general population , and 65.1 % ( CI 60.2 , 69.7 ) underestimated ovarian cancer risk among women at much higher risk than the general population .


Physicians overestimated colon more than ovarian cancer risk ( 38.0 % , CI 35.4 , 40.6 vs. 27.1 % , CI 23.0 , 31.6 ) for women at the same risk as the general population .


Physicians ' misestimation of patient ovarian and colon cancer risk may put average risk patients in jeopardy of unnecessary screening and higher risk patients in jeopardy of missed opportunities for prevention or early detection of cancers .


The endoscopically magnified operative field in functional endoscopic sinus surgery ( FESS ) makes even a small amount of bleeding a potentially significant hindrance .


It is thought that irrigation with hot saline during surgery may improve surgical field of view by producing a hemostatic effect .


Our objective was to assess the effectiveness of hot saline irrigation ( HSI ) compared to room temperature saline irrigation ( RTSI ) in the control of intraoperative bleeding during FESS .


Sixty-two chronic rhinosinusitis ( CRS ) patients undergoing FESS were randomized to 2 treatment arms in an equal ratio .


Subjects received either HSI ( 49C ) or RTSI ( 18C ) , 20 mL every 10 minutes , for the duration of FESS .


The Boezaart endoscopic field of view grading system was the primary outcome measure .


Boezaart score , heart rate , and mean arterial blood pressure ( MABP ) were recorded at 10-minute intervals between irrigations .


Mean endoscopic surgical field of view ( Boezaart score ) did not significantly differ between the HSI and RTSI groups ( 1.5 0.6 vs 1.3 0.5 ; p = 0.23 ) .


However , when FESS was longer than 2 hours in duration , the Boezaart scores were significantly better in the HSI group ( 1.6 0.6 vs 1.2 0.4 ; p = 0.04 ) .


We found that blood loss per minute was significantly reduced ( p = 0.02 ) in all cases in which HSI was used ( 2.3 1.0 ) compared to RTSI ( 1.7 1.1 ) .


Despite this , heart rate ( p = 0.32 ) and MABP ( p = 0.14 ) did not significantly differ between treatment groups .


HSI may be beneficial in improving surgical field of view in FESS after 2 hours of operating time .


A significant reduction in rate of blood loss may be attained with HSI .


Cerebral ischemia is a known complication of carotid cross-clamping during carotid endarterectomy .


Selective intraluminal shunting for cerebral protection is not always effective and carries risks .


The purpose of this study was to identify potentially modifiable risk factors for intraoperative cerebral ischemia and shunting during carotid endarterectomy .


We performed an historical case-control chart review of primary carotid endarterectomies with electroencephalographic ( EEG ) monitoring and selective shunting .


Randomized controls and cases that showed ischemic EEG changes and required shunting were matched by year of surgery and the presence or absence of a contralateral carotid occlusion .


Detailed perioperative data were collected for all cases .


Results were analyzed using the Mantel-Haenszel test , analysis of variance , and a multivariate logistic regression model .


Of 523 charts screened , 69 patients had experienced evidence of cerebral ischemia on clamping of the carotid and required shunting .


These patients were more likely than their matched controls to have been receiving regular preoperative beta blockers ( 33/69 vs 18/69 , respectively ; P = 0.01 ; odds ratio [ OR ] 2.5 ; 95 % confidence interval [ CI ] 1.2 to 5.1 ) .


Ipsilateral moderate carotid stenosis ( 60-80 % ) was also associated with increased risk .


An adjusted multivariate regression model estimated an OR of 3.6 ( 95 % CI 1.5 to 8.9 ; P = 0.005 ) for the association between use of a beta blocker and shunting .


Intraoperative hemodynamic values were similar for the shunt and control groups as well as for patients receiving and not receiving preoperative beta blockers .


The current study found an association between regular preoperative use of beta blockers and intraoperative cerebral ischemia in patients undergoing carotid endarterectomy .


This effect did not relate to intraoperative hemodynamics .


To observe the influence of Xinfengcapsule ( XFC ) on abarticular pathologic changes ( APCs ) and other indices of patients with rheumatoid arthritis ( RA ) and explore the mechanism of action of XFC in improving such changes .


Three-hundred RA patients were divided randomly into a treatment group ( n = 150 ) and control group ( n = 150 ) .


A normal control ( NC ) group ( n = 90 ) was also created .


Changes in cardiac function , pulmonary function , anemia indices and platelet parameters of RA patients were measured .


Curative effects of the two groups were compared , and comparison carried out with the NC group .


In 300 RA patients , late diastolic peak flow velocity ( A peak ) was much higher ( P < 0.01 ) and early diastolic peak flow velocity ( E peak ) , E/A , and left ventricular fraction shortening much lower ( P < 0.01 ) than those in the NC group .


Vital capacity ( VC ) , forced vital capacity in one second , forced vitalcapacity ( FVC ) , maximal voluntary ventilation ( MVV ) , maximal expiratory flow in 50 % of VC ( FEF50 ) and FEF75 were lowered remarkably ( P < 0.05 or P < 0.01 ) .


Platelet count ( PLT ) , plateletcrit ( PCT ) and mean platelet volume ( MPV ) increased markedly ( P < 0.05 or P < 0.01 ) , and hemoglobin ( Hb ) level decreased significantly ( P < 0.05 ) .


After XFC treatment , the A peak and PLT and PCT were much lower ( P < 0.05 ) , and E/A and the number of red blood cells as well as Hb level were much higher ( P < 0.05 ) , as were FVC , MVV and FEF50 ( P < 0.05 or P < 0.01 ) , in the treatment group than those in the NC group .


Total score of pain and swelling in joints , uric-acid level and high-sensitivity C-reactive protein level were much lower , and superoxide dismutase level as well as the number of CD4 + CD25 + regulation T cells ( Treg ) and CD4 + CD25 + CD127 - Treg were much higher ( P < 0.05 or P < 0.01 ) in the treatment group than those in the NC group .


RA patients with pathologic changes in joints also suffer from lower cardiac and pulmonary functions and from parameters of anemia and platelet factors .


XFC can improve the symptoms of RA patients , ameliorate their cardiac and pulmonary functions and reduce the parameters of anemia and platelet factors .


XFC lowers the immune inflammatory reaction to improve APCs in RA patients .


Although physiotherapy has demonstrated effectiveness in preventing ankle arthropathy compared to prophylaxis treatment from early ages , there have been no conclusive studies examining physiotherapy intervention once hemophilic arthropathy of the ankle has been established .


The aim of this study was to evaluate the effectiveness of two physiotherapy interventions , in patients with hemophilic arthropathy of the ankle that had not been operated on previously .


Nine patients with hemophilia ( mean age of 35.7 SD 11.9 years ) were randomized to a mobilization group ( n = 5 ) and manual therapy group ( n = 4 ) .


The two physiotherapy interventions were : ( 1 ) passive mobilization and stretching ; and ( 2 ) manual orthopaedic therapy , both with proprioception training .


The study lasted for six weeks , with two sessions a week .


Ankle mobility and pain perception , lower limb proprioception and quality of life were the outcome measures .


Both treatments improved all ankle movements ( p < 0.05 ) .


The treatment with passive mobilizations also improved the perception of pain and quality of life .


Six months later , both groups still had improved articular movement with the exception of plantar flexion and continued to perceive less pain .


Both physiotherapy interventions improved the range of movement and lessened pain in patients with ankle arthropathy .


No haemarthrosis was recorded during treatment or during the follow-up period .


To investigate the therapeutic effect of transcutaneous electrical nerve stimulation ( TENS ) on poststroke urinary incontinence ( UI ) .


Sixty-one patients with poststroke UI were enrolled at the Neurology Department in the Shanghai Tenth People 's Hospital of Tongji University between January 2010-January 2011 and were divided into treatment and control groups ( n = 32 and n = 29 , respectively ) .


TENS was applied to the treatment group , while the control group received basic therapy .


The therapeutic group completed the whole set of TENS therapy with a treatment frequency of 30 minutes once a day for 60 days .


The positive electrode was placed on the second lumbar spinous process , and the negative electrodes were inside the middle and lower third of the junction between the posterior superior iliac spine and ischia node .


The overactive bladder symptom score , Barthel Index , and urodynamics examination were estimated before and after therapy in both groups .


The daily micturition , nocturia , urgent urination , and urge UI in the treatment group significantly improved compared to the control group ( P < 0.05 ) .


The patients in the treatment group were superior in the self-care ability of daily living and also had an advantage over the indexes on maximum cystometry volume , flow rate , and the pressure of detrusor in the end of the filling phase .


TENS improved incontinence symptoms , enhanced the quality of life , and decreased adverse effects ; hence , it is recommended in treating poststroke UI .


To reveal the additional value of radiographic bitewings ( BW ) in detection of caries and in comparing the occurrence of clinically undetected severe decay between 14-year olds with and without clinically observed dentinal caries in a low-caries prevalence population .


The cross-sectional study used 363 pairs of radiographs read by one examiner without knowledge of the clinical findings .


The yield was analyzed on a tooth surface level by cross tabulating the clinical and radiographic information and on an individual level by counting the number of yield surfaces for all subjects .


Mann-Whitney U test was used .


On a tooth surface level , the contribution of BW was the greatest on the occlusal surfaces of the first molars , where established or severe dentinal decay was registered in BW in 11 % of clinically sound surfaces and in 40 % of established cavitated enamel lesions .


On an individual level , 53 % of subjects benefited from BW .


The subjects clinically DMFS > 0 benefited more than the clinically DMFS = 0 subjects ( P = .004 ) , nearly 60 % in relation to 47 % , respectively .


In a low-caries prevalence population a remarkable portion of both clinically DMFS = 0 and DMFS > 0 14-year olds benefit from BW examination .


Most of the benefit is obtained on the occlusal surfaces of the first and the second permanent molars .


The efficacy and safety of clindamycin phosphate 1.2 % / tretinoin 0.025 % ( Clin-RA ) were evaluated in three 12-week randomised studies .


To perform a pooled analysis of data from these studies to evaluate Clin-RA 's efficacy and safety in a larger overall population , in subgroups of adolescents and according to acne severity .


4550 patients were randomised to Clin-RA , clindamycin , tretinoin and vehicle .


Evaluations included percentage change in lesions , treatment success rate , proportions of patients with 50 % or 80 % continuous reduction in lesions , adverse events and cutaneous tolerability .


In the overall population , the percentage reduction in inflammatory , non-inflammatory and total lesions and the treatment success rate were significantly greater with Clin-RA compared with clindamycin , tretinoin and vehicle alone ( all p < 0.01 ) .


The percentage reduction in all types of lesions was also significantly greater with Clin-RA in the adolescent subgroup ( 2915 patients , p < 0.002 ) and in patients with mild/moderate acne ( 3662 patients , p < 0.02 ) versus comparators .


In patients with severe acne ( n = 880 ) , the percentage reduction in all lesion types was significantly greater with Clin-RA versus vehicle ( p < 0.0001 ) .


A greater proportion of Clin-RA treated patients had a 50 % or 80 % continuous reduction in all types of lesions at week 12 compared with clindamycin , tretinoin and vehicle .


Adverse event frequencies in the active and vehicle groups were similar .


Baseline-adjusted mean tolerability scores over time were < 1 ( mild ) and similar in all groups .


Clin-RA is safe , has superior efficacy to its component monotherapies and should be considered as one of the first-line therapies for mild-to-moderate facial acne .


Participant - and assessor-blinded randomized clinical trial .


To compare a rehabilitation program thought to increase the size of the intervertebral foramen ( IVF ) of the affected nerve root to a rehabilitation program that does n't include any specific techniques thought to increase the size of the IVF in patients presenting with cervical radiculopathy ( CR ) .


Clinical approaches for the treatment of CR commonly include exercises and manual therapy techniques thought to increase the size of the IVF , but evidence regarding the effectiveness of these specific manual therapy techniques is scarce .


Thirty-six participants with CR were randomly assigned either to a group that received a manual therapy and exercise program aimed at increasing the size of the IVF of the affected nerve root ( experimental group , n = 18 ) or to a group that received a manual therapy and exercise program without the specific goal of increasing the size of the IVF of the affected level and side ( comparison group , n = 18 ) .


Primary ( Neck Disability Index ) and secondary ( shortened version of the Disabilities of the Arm , Shoulder and Hand questionnaire [ QuickDASH ] and numeric pain-rating scale ) outcomes were evaluated at baseline , at the end of the 4-week program ( week 4 ) , and 4 weeks later ( week 8 ) .


A mixed-model , 2-way analysis of variance was used to analyze treatment effects .


No significant group-by-time interaction or group effect was observed for Neck Disability Index , QuickDASH , and numeric pain-rating scale scores ( P. 14 ) following the intervention .


However , both groups showed statistically and clinically significant improvement from baseline to week 4 and to week 8 in Neck Disability Index , QuickDASH , and numeric pain-rating scale scores ( P < .05 ) .


Results suggest that manual therapy and exercises are effective in reducing pain and functional limitations related to CR .


The addition of techniques thought to increase the size of the IVF of the affected nerve root yielded no significant additional benefits .


Given the absence of a `` no treatment '' group , a spontaneous resolution of symptoms can not be excluded .


However , the magnitude of improvement makes spontaneous resolution unlikely .


The trial was registered at ClinicalTrials.gov ( NCT01500044 ) .


Therapy , level 1b - .


To study the changes of adenosine diphosphate ( ADP ) - induced platelet aggregation rate , and evaluate the effects of Maixuekang Capsule ( , MKC ) on platelet aggregation rate and long-term prognosis of patients with acute coronary syndrome after percutaneous coronary intervention ( PCI ) .


A total of 236 patients with acute coronary syndrome , who received successful PCI , were randomly assigned to a trial group ( 116 cases ) and a control group ( 120 cases ) according to random numbers ; treatment allocation occurred when the participants met the inclusion criteria and signed the informed consent forms .


In the trial group , the patients were treated with MKC combined with routine medication , and in the control group the patients were treated with routine medication .


The therapeutic course for the two groups was 12 months and the follow-up was 12 months .


The levels of ADP-induced platelet aggregation rate and serum high-sensitive C-reactive protein ( hs-CRP ) were determined before PCI , 12 h and 30 days after PCI .


In the meantime , the incidence of cardio - / cerebrovascular events was recorded during the 12-month follow-up .


Compared with before PCI , the levels of ADP-induced platelet aggregation rate and serum hs-CRP were significantly higher at 12 h after PCI ( P < 0.05 ) .


They were significantly reduced after 30-day-treatment of MKC , showing statistical differences when compared with those in the control group ( P < 0.05 ) .


During the 12-month follow-up , the incidence of cardio - / cerebrovascular events was significantly lower in the trial group than in the control group ( 6.9 % vs. 12.5 % , P < 0.01 ) .


ADP-induced platelet aggregation function was significantly elevated after PCI .


MKC improved the prognosis of patients with acute coronary syndrome , possibly through inhibiting the platelet aggregation , fighting against inflammation , and protecting the vascular endothelial function .


To test the hypothesis that telemedicine can reliably be used for many aspects of circulatory and neurologic examinations of children admitted to a pediatric intensive care unit ( PICU ) .


A prospective , randomized study in a 14-bed PICU in a tertiary care , academic-affiliated institution .


Eligible patients were > 2 months or < 19 years of age , not involved in a concurrent study , had parents/guardian able to sign an informed consent form , were not at end-of-life , and had an attending who not only deemed them medically stable , but also felt that the study would not interrupt their care .


Other than the Principal Investigator , 6 pediatric intensivists and 7 pediatric critical care fellows were eligible study providers .


Two physician providers were randomly assigned to perform circulatory and neurologic examinations according to the American Heart Association/Pediatric Advanced Life Support guidelines in-person and via telemedicine .


Findings were recorded on a standardized data collection form and compared .


One hundred ten data collection forms were completed .


For many aspects of the circulatory and neurologic examinations , outcomes showed substantial to perfect agreement between the in-person and telemedical care providers ( kappa = 0.64-1 .00 ) .


However , assessments of muscle tone had a kappa = 0.23 , with a kappa = 0.37 for skin color .


Telemedicine can reliably identify normal and abnormal findings of many aspects of circulatory and neurologic examinations in PICU patients .


This finding opens the door to further studies on the use of telemedicine across other disciplines .


Vitamin C has been proposed to improve outcomes after a distal radial fracture by promotion of bone and soft-tissue healing and reduction of the prevalence of complex regional pain syndrome ( CRPS ) .


Our primary aim was to examine the effect of vitamin C on functional outcome after a distal radial fracture .


A total of 336 adult patients with an acute fracture of the distal aspect of the radius were recruited over a one-year period and randomized to receive 500 mg of vitamin C or placebo daily for fifty days after the fracture .


The primary outcomes were the DASH ( Disabilities of the Arm , Shoulder and Hand ) score at six weeks and at one year .


Secondary variables included complications , wrist and finger motion , grip and pinch strength , pain , and a CRPS score .


There were no significant differences in patient or fracture characteristics between the treatment groups .


There was no significant effect of vitamin C on the DASH score throughout the study period .


At six weeks , patients in the vitamin C group with a nondisplaced fracture had a significantly greater wrist flexion deficit ( p = 0.008 ) and pinch strength deficit ( p = 0.020 ) and a greater rate of CRPS ( p = 0.022 ) , but there was no difference in the CRPS rate at any other time point .


At twenty-six weeks , there was a higher rate of complications ( p = 0.043 ) and greater pain with use ( p = 0.045 ) in the patients with a displaced fracture treated with vitamin C.


There was no significant difference in the time to fracture-healing .


This study demonstrated no significant difference at one year in the DASH score , other functional outcomes , the rate of CRPS , or osseous healing of nondisplaced or displaced distal radial fractures treated with vitamin C compared with placebo .


We conclude that administration of vitamin C confers no benefit to patients with a displaced or nondisplaced fracture of the distal aspect of the radius .


Therapeutic Level II .


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


Heart failure ( HF ) is a common but serious condition which involves a significant economic burden on the health care economy .


The purpose of this study was to evaluate cost and quality of life ( QoL ) implications of implementing a HF management program ( HFMP ) in primary health care ( PHC ) .


This was a prospective randomized open-label study including 160 patients with a diagnosis of HF from five PHC centers in south-eastern Sweden .


Patients randomized to the intervention group received information about HF from HF nurses and from a validated computer-based awareness program .


HF nurses and physicians followed the patients intensely in order to optimize HF treatment according to current guidelines .


The patients in the control group were followed by their regular general practitioner ( GP ) and received standard treatment according to local management routines .


No significant changes were observed in NYHA class and quality-adjusted life years ( QALY ) , implying that functional class and QoL were preserved .


However , costs for hospital care ( HC ) and PHC were reduced by EUR 2167 , or 33 % .


The total cost was EUR 4471 in the intervention group and EUR 6638 in the control group .


Introducing HFMP in Swedish PHC in patients with HF entails a significant reduction in resource utilization and costs , and maintains QoL .


Based on these results , a broader implementation of HFMP in PHC may be recommended .


However , results should be confirmed with extended follow-up to verify long-term effects .


Postoperative nausea and vomiting ( PONV ) is one of common complications in patients undergoing laparoscopic cholecystectomy ( LC ) .


Aim of this study was to compare the efficacy of subhypnotic ( 1 mg/kg/h ) infusion of propofol with dexamethasone on PONV in patients undergoing LC .


A total of 120 patients were included in this randomized , double-blind , placebo-controlled study .


Patients were randomly assigned to 3 groups ; patients of group dexamethasone ( group D ) were administrated 8 mg dexamethasone before induction of anesthesia , patients of group propofol ( group P ) were infused to subhypnotic ( 1 mg/kg/h ) propofol during operation and patients of group control ( group C ) were applied infusion of 10 % intralipid .


The incidence of PONV and needs for rescue analgesic and antiemetic were recorded in the first 24 h postoperatively .


In the 0-24 h , the incidence of PONV was significantly lower in the group D and group P compared with the group C ( 37.5 % , 40 % , and 72.5 % , resp . )


There was no significant difference in the incidence of PONV and use of antiemetics and analgesic between group D and group P.


We concluded that infusion of propofol 1 mg/kg/h is as effective as dexamethasone for the prevention of PONV during the first 24 hours after anesthesia in patients undergoing LC .


The ODYSSEY COMBO I study ( http://clinicaltrials.gov/show/NCT01644175 ) evaluated efficacy and safety of alirocumab as add-on therapy to stable maximally tolerated daily statin with or without other lipid-lowering therapy in high cardiovascular risk patients with suboptimally controlled hypercholesterolemia .


This multicenter , phase 3 , randomized ( 2:1 alirocumab vs placebo ) , double-blind , 52-week trial enrolled 316 patients with established coronary heart disease or coronary heart disease risk equivalents and hypercholesterolemia .


Alirocumab ( 75 mg every 2 weeks [ Q2W ] ) or placebo Q2W was self-administered subcutaneously via 1 mL prefilled pen .


The alirocumab dose was increased to 150 mg Q2W ( also 1 mL ) at week 12 if week 8 low-density lipoprotein cholesterol ( LDL-C ) was 70 mg/dL .


The primary efficacy end point was percent change in LDL-C from baseline to week 24 ( intention-to-treat analysis ) .


At week 24 , estimated mean ( 95 % CI ) changes in LDL-C from baseline were -48.2 % ( -52.0 % to -44.4 % ) and -2.3 % ( -7.6 % to 3.1 % ) for alirocumab and placebo , respectively , an estimated mean ( 95 % CI ) difference of -45.9 % ( -52.5 % to -39.3 % ) ( P < .0001 ) .


Low-density lipoprotein cholesterol < 70 mg/dL was achieved by 75 % alirocumab versus 9 % placebo patients at week 24 .


At week 12 , 83.2 % of evaluable alirocumab-treated patients remained on 75-mg Q2W .


Treatment-emergent adverse events were comparable between groups .


Alirocumab treatment achieved a significantly greater reduction in LDL-C and allowed a greater proportion of patients to achieve LDL-C goals , versus placebo after 24 weeks in high cardiovascular risk patients with suboptimally controlled hypercholesterolemia at baseline despite receiving maximally tolerated statin with or without other lipid-lowering therapy .


The frequency of treatment-emergent adverse events and study medication discontinuations were generally comparable between treatment groups .


The Trial to Assess Chelation Therapy ( TACT ) showed clinical benefit of an EDTA-based infusion regimen in patients aged 50 years with prior myocardial infarction .


Diabetes mellitus before enrollment was a prespecified subgroup .


Patients received 40 infusions of EDTA chelation or placebo .


A total of 633 ( 37 % ) patients had diabetes mellitus ( 322 EDTA and 311 placebo ) .


EDTA reduced the primary end point ( death , reinfarction , stroke , coronary revascularization , or hospitalization for angina ; 25 % versus 38 % ; hazard ratio , 0.59 ; 95 % confidence interval [ CI ] , 0.44-0 .79 ; P < 0.001 ) over 5 years .


The result remained significant after Bonferroni adjustment for multiple subgroups ( 99.4 % CI , 0.39-0 .88 ; adjusted P = 0.002 ) .


All-cause mortality was reduced by EDTA chelation ( 10 % versus 16 % ; hazard ratio , 0.57 ; 95 % CI , 0.36-0 .88 ; P = 0.011 ) , as was the secondary end point ( cardiovascular death , reinfarction , or stroke ; 11 % versus 17 % ; hazard ratio , 0.60 ; 95 % CI , 0.39-0 .91 ; P = 0.017 ) .


However , after adjusting for multiple subgroups , those results were no longer significant .


The number needed to treat to reduce 1 primary end point over 5 years was 6.5 ( 95 % CI , 4.4-12 .7 ) .


There was no reduction in events in non-diabetes mellitus ( n = 1075 ; P = 0.877 ) , resulting in a treatment by diabetes mellitus interaction ( P = 0.004 ) .


Post-myocardial infarction patients with diabetes mellitus aged 50 demonstrated a marked reduction in cardiovascular events with EDTA chelation .


These findings support efforts to replicate these findings and define the mechanisms of benefit .


However , they do not constitute sufficient evidence to indicate the routine use of chelation therapy for all post-myocardial infarction patients with diabetes mellitus .


URL : http://www.clinicaltrials.gov .


Unique identifier : NCT00044213 .


To compare the efficacy differences between dog-days medicinal vesiculation and regular-day medicinal vesiculation for perennial allergic rhinitis ( PAR ) , and observe their effects on serum immune globulin E ( IgE ) and interleukin-4 ( IL-4 ) .


Seventy-two patients were randomly divided into a dog-days moxibustion group ( 34 cases ) and a regular-day moxibustion group ( 38 cases ) .


In the dog-days moxibustion group , medicinal vesiculation was applied on the 1st dog-day , 2nd dog-day and last dog-day in summer by lunar calendar , 3 treatments per dog-day for totally 9 times .


In the regular-day moxibustion group , the moxibustion was given on the regular day for continuous 9 times .


The symptom score , rhinoconjunctivitis quality of life questionnaire ( RQLQ ) and the level of IgE and IL-4 were compared before and after treatment in two groups ; the short-term and two-year efficacy evaluation were performed too .


The short-term total effective rate was 88.2 % ( 30/34 ) in the dog-days moxibustion group , which was not significantly different to 86.8 % ( 33/38 ) in the regular-day moxibustion group ( P > 0.05 ) .


The long-term total effective rate was 97.1 % ( 33/34 ) in the dog-days moxibustion group , which was significantly superior to 81.6 % ( 31/38 ) in the regular-day moxibustion group ( P < 0.05 ) .


After treatment , the serum IgE , IL-4 and RQLQ were significantly reduced ( all P < 0.01 ) , but the difference between two groups was not significant ( all P > 0.05 ) .


Medicinal moxibustion could be taken as a regular treatment for PAR , which could be performed during the whole year , and dog-days moxibustion could be considered as an enhanced method for prevention and treatment of PAR .


The prefrontal cortex may be a promising target for the use of transcranial direct current stimulation ( tDCS ) in the management of pain symptoms .


The present study explored the effects of anodal and cathodal tDCS over the left dorsolateral prefrontal cortex on the effects of perceived pain controllability .


Forty-one participants received continuous anodal or cathodal tDCS and underwent a laboratory pain task designed to manipulate the perception of pain control .


Participants were told that they would be completing a reaction-time task ( press keyboard button of corresponding arrow shown on computer screen with either green or red background ) .


A thermal pain stimulus was delivered following each trial by a thermode placed on the participant 's left forearm .


Although pain stimuli were pseudorandomally ordered and matched for total duration between control ( green ) and noncontrol ( red ) trials , participants were told that if they responded correctly and more quickly on green trials than their average reaction times , the thermal pain stimulus duration would be decreased ( ie , perceived control ) .


Participants were told they had no control of pain stimulus duration over trials presented with the red background .


There was a significant main effect for tDCS condition ( anode vs. cathode ) on pain unpleasantness ratings ( P < 0.04 ) .


Specifically , individuals receiving cathodal tDCS reported higher pain unpleasantness ratings ( least squares mean = 69.40 , SE = 3.72 ) , whereas those receiving anodal tDCS reported lower pain unpleasantness ratings ( least squares mean = 58.05 , SE = 3.81 ) .


Exploratory analysis revealed a simple main effect for tDCS group at the level of perceived controllability ( P < 0.02 ) .


In addition , participants receiving cathodal tDCS subjectively reported feeling less control of the painful stimuli than those receiving anodal tDCS .


Left dorsolateral prefrontal cortex tDCS may play a role in modulating the neurocircuitry involved with the perception of control over pain .


Hereditary angioedema ( HAE ) is a rare disease caused by C1-esterase inhibitor ( C1-INH ) deficiency , characterized by periodic attacks of acute edema affecting subcutaneous ( SC ) tissues and mucous membranes .


Human C1-INH concentrate given intravenously ( IV ) is effective and safe , but venous access may be difficult .


We compared SC and IV administration of human pasteurized C1-INH concentrate with respect to pharmacokinetics , pharmacodynamics , and safety .


This was a prospective , randomized , open-label , crossover study .


Twenty-four subjects with mild or moderate HAE were randomly assigned during an attack-free interval to receive 1000 units of human pasteurized C1-INH concentrate IV or SC .


Plasma levels of C1-INH activity and antigen , C4 antigen , cleaved high-molecular-weight kininogen ( clHK ) , and C1-INH antibodies were measured .


The mean relative bioavailability of functional C1-INH after SC administration was 39.7 % .


Maximum C1-INH activity after SC administration occurred within 48 hours and persisted longer than after IV administration .


C4 antigen levels increased and clHK levels decreased after IV and SC administration , indicating the pharmacodynamic action of C1-INH .


The mean half-life of functional C1-INH was 62 hours after IV administration and 120 hours after SC administration ( p = 0.0595 ) .


C1-INH concentrate was safe and well tolerated when administered via both routes .


As expected , SC administration resulted in a higher incidence of injection site reactions , all of which were mild .


With a relative bioavailability of 39.7 % , SC administration of human pasteurized C1-INH yields potentially clinically relevant and sustained plasma levels of C1-INH and is safe and well tolerated .


Safe parenteral drug administration includes preparation of safe medication for administration .


Training medical students is crucial to minimize medication administration errors .


The study aims to develop a module to teach drug preparation skills and to develop objective structured practical examination ( OSPE ) stations to assess these skills .


Students ' perceptions regarding the module were also assessed .


A module was developed to teach following skills to 2 ( nd ) year medical students : Aspiration of a drug from the ampule , aspiration of the drug from the vial , aspiration of the drug in powdered form from vial ( reconstitution ) , and setting up an intravenous ( IV ) infusion .


A randomized case control study design was used to establish the validity of OSPE stations .


Student volunteers were grouped into case ( n = 20 ) and control groups ( n = 20 ) by simple randomization .


The test group watched videos of skills and received demonstration of skills and a practice session before OSPE , whereas the control group watched videos before the OSPE and received demonstration and a practice session only after the OSPE .


Each student was assessed by two faculty members during OSPE using a validated checklist .


Mean OSPE scores of control and test groups were compared using independent samples t-test .


Interrater reliability and concurrent validity of stations were analyzed using interclass correlation coefficient ( ICC ) and Pearson correlation , respectively .


Students ' responses were expressed as median and interquartile range .


The response rate in the questionnaire was 100 % .


Significant difference between mean scores ( P < 0.05 ) of test and control groups revealed fulfillment of construct validity of OSPE stations .


Interrater reliability ( ICC > 0.7 ) and concurrent validity ( r value > 7 ) of all the stations was high .


Perceptions revealed acceptability of module and OSPE stations by students ( median 4 , scale 1-5 ) .


A module to teach drug preparation skills was developed and along with valid and reliable OSPE stations that were acceptable to students .


The study demonstrated that students acquire better skills through teaching than merely watching these skills in videos .


Medication nonadherence is a major obstacle to better control of glucose , blood pressure ( BP ) , and LDL cholesterol in adults with diabetes .


Inexpensive effective strategies to increase medication adherence are needed .


In a pragmatic randomized trial , we randomly assigned 2,378 adults with diabetes mellitus who had recently been prescribed a new class of medication for treating elevated levels of glycated hemoglobin ( A1C ) 8 % ( 64 mmol/mol ) , BP 140/90 mmHg , or LDL cholesterol 100 mg/dL , to receive 1 ) one scripted telephone call from a diabetes educator or clinical pharmacist to identify and address nonadherence to the new medication or 2 ) usual care .


Hierarchical linear and logistic regression models were used to assess the impact on 1 ) the first medication fill within 60 days of the prescription ; 2 ) two or more medication fills within 180 days of the prescription ; and 3 ) clinically significant improvement in levels of A1C , BP , or LDL cholesterol .


Of the 2,378 subjects , 89.3 % in the intervention group and 87.4 % in the usual-care group had sufficient data to analyze study outcomes .


In intent-to-treat analyses , intervention was not associated with significant improvement in primary adherence , medication persistence , or intermediate outcomes of care .


Results were similar across subgroups of patients defined by age , sex , race/ethnicity , and study site , and when limiting the analysis to those who completed the intended intervention .


This low-intensity intervention did not significantly improve medication adherence or control of glucose , BP , or LDL cholesterol .


Wide use of this strategy does not appear to be warranted ; alternative approaches to identify and improve medication adherence and persistence are needed .


We conducted a prospective trial of BRAF and mitogen-activated protein kinase kinase ( MEK ) targeted therapy in advanced , operable BRAF mutation-positive melanoma to determine feasibility , tumor response rates , and biomarkers of response and resistance .


Thirteen patients with locally or regionally advanced BRAF mutation-positive melanoma received dabrafenib 150 mg po bid for 14 days , followed by dabrafenib plus trametinib 2 mg po daily for 14 days before operation .


Biopsies and tumor measurements were obtained at baseline and days 14 and 28 .


Formalin-fixed paraffin embedded specimens were analyzed with hematoxylin and eosin , Ki-67 , cleaved caspase-3 , CD8 , phosphorylated extracellular signal-regulated kinase ( ERK ) , and phosphorylated MEK immunostains .


Therapy was tolerated well , with toxicity grade 3 in 2 of 13 ( 15 % ) patients .


All 12 patients receiving > 14 days of therapy had substantial reduction in tumor volume ( 65 % at day 14 and 78 % at day 28 ) and underwent resection .


After 14 days of dabrafenib therapy , there was a marked reduction in viable melanoma cells and a CD8 T-cell -- rich infiltrate .


Proliferation of the residual melanoma cells was reduced and apoptosis was increased .


The cells continued to express phosphorylated ERK and phosphorylated MEK consistent with incomplete mitogen-activated protein kinase pathway inhibition .


Preoperative targeted therapy of advanced BRAF-mutant melanoma is feasible , well tolerated , induces brisk tumor responses , and facilitates correlative science .


A CD8 T-cell-rich infiltrate indicates a potential immune-mediated mechanism of action .


Both proliferation and apoptosis were inhibited , but the mitogen-activated protein kinase pathway remained activated , suggesting intrinsic resistance in a subset of tumor cells .


Additional investigation of the anti-tumor immune response during targeted therapy and the mechanisms of intrinsic resistance can yield novel therapeutic strategies .


Subarachnoid administration of opioids such as pethidine and fentanyl had been proven safe but that oftramadol has been controversial .


Tramadol is cheap and readily available , hence the need to further evaluate its intrathecal safety .


The study aimed at determining the hemodynamic and side effect profile of intrathecal tramadol .


One hundred and eighty six ( 186 ) ASA I or II patients scheduled for emergency open appendicectomy under spinal anesthesia were included in the study .


Group BF ( n = 62 ) received intrathecal fentanyl 25 microg plus 3 ml of 0.5 % hyperbaric bupivacaine , Group BS ( n = 62 ) received 0.5 ml normal saline plus 3 ml of 0.5 % hyperbaric bupivacaine and Group BT ( n = 62 ) received intrathecal tramadol 25 mg plus 3 ml of 0.5 % hyperbaric bupivacaine .


Hemodynamic profile and side effects were monitored intraoperatively and 12 hours postoperatively .


Fifteen ( 24.2 % ) , 13 ( 20.9 % ) and 15 ( 24.5 % ) patients respectively in Groups BF , BS and BT had hypotension ( P = 0.886 ) .


The incidence of postoperative vomiting occurred in 2 patients ( 3.2 % ) in Group BF as compared to 3 patients ( 4.8 % ) in Group BS and 10 patients ( 16.1 % ) in Group BT ( P = 0.016 ) .


No surgeon in Group BF reported dissatisfaction but 18 patients ( 29 % ) in Group BS and 1 patient ( 1.6 % ) in Group BT had their surgeons reporting dissatisfaction ( P = 0.0001 ) .


This study shows that intrathecal tramadol 25 mg has higher incidence of post operative nausea and vomitting than 25 microg of intrathecal fentanyl but both drugs were safe .


Once-weekly administration of 56.5 g teriparatide improved cortical bone parameters and biomechanical parameters at the proximal femur by CT geometry analysis .


The aim of this study was to evaluate the effects of weekly administration of teriparatide [ human PTH ( 1-34 ) ] on bone geometry , volumetric bone mineral density ( vBMD ) , and parameters of bone strength at the proximal femur which were longitudinally investigated using computed tomography ( CT ) .


The subjects were a subgroup of a recent , randomly assigned , double-blind study ( 578 subjects ) comparing the anti-fracture efficacy of a once-weekly subcutaneous injection of 56.5 g teriparatide with placebo ( TOWER trial ) .


Sixty-six ambulatory postmenopausal women with osteoporosis were enrolled at 15 study sites having multi-detector row CT , and included women injected with teriparatide ( n = 29 , 74.2 5.1 years ) or with placebo ( n = 37 , 74.8 5.3 years ) .


CT data were obtained at baseline and follow-up scans were performed at 48 and 72 weeks .


The data were analyzed to obtain cross-sectional densitometric , geometric , and biomechanical parameters including the section modulus ( SM ) and buckling ratio ( BR ) of the femoral neck , inter-trochanter , and femoral shaft .


We found that once-weekly teriparatide increased cortical thickness/cross-sectional area ( CSA ) and total area , and improved biomechanical properties ( i.e. , decreasing BR ) at the femoral neck and shaft .


Teriparatide did not change the cortical perimeter .


Our longitudinal analysis of proximal femur geometry by CT revealed that once-weekly administration of 56.5 g teriparatide improved cortical bone parameters at the femoral neck and shaft and also improved biomechanical parameters .


Age-related endothelial dysfunction and vascular stiffening are associated with increased cardiovascular ( CV ) risk .


Many groups have encouraged goals of 10 000 steps/day or 30 min/day of moderate intensity physical activity ( MPA ) to reduce age-related CV risk .


The impact of MPA on the vasculature of older adults remains unclear .


We randomized 114 sedentary older adults ages 50 to 12 weeks of either no intervention ( group 1 ) , a pedometer-only intervention ( group 2 ) , or a pedometer with an interactive website employing strategies to increase the adoption of habitual physical activity ( PA , group 3 ) .


Endothelial function by brachial flow-mediated dilation ( FMD % ) , vascular stiffness by tonometry , step-count by pedometer , and PA intensity/distribution by accelerometer were measured .


Step-count increased in groups 2 ( 51361554 to 95963907 , P < 0.001 ) and 3 ( 54741512 to 81673111 , P < 0.001 ) but not in group 1 ( 49311667 to 54102410 ) .


Both groups 2 and 3 increased MPA 30 min/day .


Only group 3 increased MPA in continuous bouts of 10 minutes ( P < 0.001 ) and improved FMD % ( P = 0.001 ) .


Neither achievement of 10 000 steps/day nor 30 min/day of MPA resulted in improved FMD % .


However , achieving 20 min/day in MPA bouts resulted in improved FMD % .


No changes in vascular stiffness were observed .


MPA reverses age-related endothelial dysfunction , but may require MPA to be performed in bouts of 10 minutes duration for 20 min/day to be effective .


Commonly encouraged PA goals do not guarantee improved endothelial function and may not be as effective in reducing CV risk .


Clinicaltrials.gov .


UNIQUE IDENTIFIER : NCT-01212978 .


A wide range of effective smoking cessation interventions have been developed to help smokers to quit .


Smoking rates remain high , especially among people with a lower level of education .


Multiple tailoring adapted to the individual 's readiness to quit and the use of visual messaging may increase smoking cessation .


The results of video and text computer tailoring were compared with the results of a control condition .