To investigate the efficacy of 6 weeks of daily low-dose oral prednisolone in improving pain , mobility , and systemic low-grade inflammation in the short term and whether the effect would be sustained at 12 weeks in older adults with moderate to severe knee osteoarthritis ( OA ) .


A total of 125 patients with primary knee OA were randomized 1:1 ; 63 received 7.5 mg/day of prednisolone and 62 received placebo for 6 weeks .


Outcome measures included pain reduction and improvement in function scores and systemic inflammation markers .


Pain was assessed using the visual analog pain scale ( 0-100 mm ) .


Secondary outcome measures included the Western Ontario and McMaster Universities Osteoarthritis Index scores , patient global assessment ( PGA ) of the severity of knee OA , and 6-min walk distance ( 6MWD ) .


Serum levels of interleukin 1 ( IL-1 ) , IL-6 , tumor necrosis factor ( TNF ) - , and high-sensitivity C-reactive protein ( hsCRP ) were measured .


There was a clinically relevant reduction in the intervention group compared to the placebo group for knee pain , physical function , PGA , and 6MWD at 6 weeks .


The mean difference between treatment arms ( 95 % CI ) was 10.9 ( 4.8-18 .0 ) , p < 0.001 ; 9.5 ( 3.7-15 .4 ) , p < 0.05 ; 15.7 ( 5.3-26 .1 ) , p < 0.001 ; and 86.9 ( 29.8-144 .1 ) , p < 0.05 , respectively .


Further , there was a clinically relevant reduction in the serum levels of IL-1 , IL-6 , TNF - , and hsCRP at 6 weeks in the intervention group when compared to the placebo group .


These differences remained significant at 12 weeks .


The Outcome Measures in Rheumatology Clinical Trials-Osteoarthritis Research Society International responder rate was 65 % in the intervention group and 34 % in the placebo group ( p < 0.05 ) .


Low-dose oral prednisolone had both a short-term and a longer sustained effect resulting in less knee pain , better physical function , and attenuation of systemic inflammation in older patients with knee OA ( ClinicalTrials.gov identifier NCT01619163 ) .


Emotional eating is associated with overeating and the development of obesity .


Yet , empirical evidence for individual ( trait ) differences in emotional eating and cognitive mechanisms that contribute to eating during sad mood remain equivocal .


The aim of this study was to test if attention bias for food moderates the effect of self-reported emotional eating during sad mood ( vs neutral mood ) on actual food intake .


It was expected that emotional eating is predictive of elevated attention for food and higher food intake after an experimentally induced sad mood and that attentional maintenance on food predicts food intake during a sad versus a neutral mood .


Participants ( N = 85 ) were randomly assigned to one of the two experimental mood induction conditions ( sad/neutral ) .


Attentional biases for high caloric foods were measured by eye tracking during a visual probe task with pictorial food and neutral stimuli .


Self-reported emotional eating was assessed with the Dutch Eating Behavior Questionnaire ( DEBQ ) and ad libitum food intake was tested by a disguised food offer .


Hierarchical multivariate regression modeling showed that self-reported emotional eating did not account for changes in attention allocation for food or food intake in either condition .


Yet , attention maintenance on food cues was significantly related to increased intake specifically in the neutral condition , but not in the sad mood condition .


The current findings show that self-reported emotional eating ( based on the DEBQ ) might not validly predict who overeats when sad , at least not in a laboratory setting with healthy women .


Results further suggest that attention maintenance on food relates to eating motivation when in a neutral affective state , and might therefore be a cognitive mechanism contributing to increased food intake in general , but maybe not during sad mood .


Although working smoke alarms halve deaths in residential fires , many households do not keep alarms operational .


We tested whether theory-based education increases alarm operability .


Randomised multiarm trial , with a single arm randomly selected for use each day , in low-income neighbourhoods in Maryland , USA .


Intervention arms : ( 1 ) Full Education combining a health belief module with a social-cognitive theory module that provided hands-on practice installing alarm batteries and using the alarm 's hush button ; ( 2 ) Hands-on Practice social-cognitive module supplemented by typical fire department education ; ( 3 ) Current Norm receiving typical fire department education only .


Four hundred and thirty-six homes recruited through churches or by knocking on doors in 2005-2008 .


Follow-up visits checked alarm operability in 370 homes ( 85 % ) 1-3 .5 years after installation .


number of homes with working alarms defined as alarms with working batteries or hard-wired and number of working alarms per home .


Regressions controlled for alarm status preintervention ; demographics and beliefs about fire risks and alarm effectiveness .


Homes in the Full Education and Practice arms were more likely to have a functioning smoke alarm at follow-up ( OR = 2.77 , 95 % CI 1.09 to 7.03 ) and had an average of 0.32 more working alarms per home ( 95 % CI 0.09 to 0.56 ) .


Working alarms per home rose 16 % .


Full Education and Practice had similar effectiveness ( p = 0.97 on both outcome measures ) .


Without exceeding typical fire department installation time , installers can achieve greater smoke alarm operability .


Hands-on practice is key .


Two years after installation , for every three homes that received hands-on practice , one had an additional working alarm .


http://www.clinicaltrials.gov number NCT00139126 .


To evaluate the performance ( efficacy , safety and acceptability ) of a new micro-adherent absorbent dressing ( UrgoClean ) compared with a hydrofiber dressing ( Aquacel ) in the local management of venous leg ulcers , in the debridement stage .


A non-inferiority European randomised controlled clinical trial ( RCT ) was conducted in 37 centres , on patients presenting with venous or predominantly venous , mixed aetiology leg ulcers at their sloughy stage ( with more than 70 % of the wound bed covered with slough at baseline ) .


Patients were followed over a 6-week period and assessed weekly .


The primary judgement criteria was the relative regression of the wound surface area after the 6-week treatment period .


Secondary endpoints were the relative reduction of sloughy tissue and the percentage of patients presenting with a debrided wound .


Altogether , 159 patients were randomised to either UrgoClean ( test group ; n = 83 ) or Aquacel ( control group ; n = 76 ) dressings .


Regarding the wound healing process predictive factors ( wound area , duration , ABPI value , recurrence ) , at baseline , the two groups were well balanced , for both wound and patient characteristics .


Compression therapy was administered to both groups and after a median 42-day treatment period , the percentage of relative reduction of the wound surface area was very similar ( -36.9 % vs -35.4 % in the UrgoClean and control groups , respectively ) .


When considering the secondary criteria at week 6 , the relative reduction of sloughy tissue was significantly higher in the UrgoClean group than in the control group ( -65.3 % vs -42,6 % ; p = 0.013 ) .


The percentage of debrided wounds was also significantly higher in the test group ( 52.5 % vs 35.1 % ; p = 0.033 ) .


This ` EARTH ' RCT confirmed that the UrgoClean dressing has similar efficacy and safety compared to Aquacel .


However , UrgoClean also showed better autolytic properties than the control group in the management of venous leg ulcers at the sloughy stage .


The new UrgoClean dressing therefore represents a promising therapeutic option within the current range of autolytic dressings available .


This study was sponsored by a grant from the pharmaceutical company Laboratoires Urgo .


S. Bohbot and O. Tacca are employees of Laboratoires Urgo .


S. Meaume , J. Dissemond and G. Perceau have received monetary compensation as presenters for Laboratoires Urgo .


Data management and statistical analyses were conducted independently by Vertical ( Paris , France ) .


Eye movements ( EM ) during recall of an aversive memory is a treatment element unique to Eye Movement Desensitization and Reprocessing ( EMDR ) .


Experimental studies have shown that EM reduce memory vividness and/or emotionality shortly after the intervention .


However , it is unclear whether the immediate effects of the intervention reflect actual changes in memory .


The aim of this study was to test whether immediate reductions in memory vividness and emotionality persist at a 24h follow up and whether the magnitude of these effects is related to the duration of the intervention .


Seventy-three undergraduates recalled two negative autobiographical memories , one with EM ( `` recall with EM '' ) and one without ( `` recall only '' ) .


Half of participants recalled each memory for four periods of 24s , the other half for eight periods of 24s .


Memory vividness/emotionality were self-rated at a pre-test , an immediate post-test , and a 24h follow-up test .


In both duration groups , recall with EM , but not recall only , caused an immediate decrease in memory vividness .


There were no immediate reductions in memory emotionality .


Furthermore , only the ` eight periods ' group showed that recall with EM , but not recall only , caused a decrease in both memory emotionality and memory vividness from the pre-test to the follow-up .


Only self-report measures were used .


The findings suggest that recall with EM causes 24-hchanges in memory vividness/emotionality , which may explain part of the EMDR treatment effect , and these effects are related to intervention duration .


Few studies have tested the impact of motivational interviewing ( MI ) delivered by primary care providers on pediatric obesity .


This study tested the efficacy of MI delivered by providers and registered dietitians ( RDs ) to parents of overweight children aged 2 through 8 .


Forty-two practices from the Pediatric Research in Office Settings Network of the American Academy of Pediatrics were randomly assigned to 1 of 3 groups .


Group 1 ( usual care ) measured BMI percentile at baseline and 1 - and 2-year follow-up .


Group 2 ( provider only ) delivered 4 MI counseling sessions to parents of the index child over 2 years .


Group 3 ( provider + RD ) delivered 4 provider MI sessions plus 6 MI sessions from a RD. .


The primary outcome was child BMI percentile at 2-year follow up .


At 2-year follow-up , the adjusted BMI percentile was 90.3 , 88.1 , and 87.1 for groups 1 , 2 , and 3 , respectively .


The group 3 mean was significantly ( P = .02 ) lower than group 1 .


Mean changes from baseline in BMI percentile were 1.8 , 3.8 , and 4.9 across groups 1 , 2 , and 3 .


MI delivered by providers and RDs ( group 3 ) resulted in statistically significant reductions in BMI percentile .


Research is needed to determine the clinical significance and persistence of the BMI effects observed .


How the intervention can be brought to scale ( in particular , how to train physicians to use MI effectively and how best to train RDs and integrate them into primary care settings ) also merits future research .


Antithrombin ( AT ) concentrations are reduced after cardiac surgery with cardiopulmonary bypass compared with the preoperative levels .


Low postoperative AT is associated with worse short - and mid-term clinical outcomes .


The aim of the study is to evaluate the effects of AT administration on activation of the coagulation and fibrinolytic systems , platelet function , and the inflammatory response in patients with low postoperative AT levels .


Sixty patients with postoperative AT levels of less than 65 % were randomly assigned to receive purified AT ( 5000 IU in three administrations ) or placebo in the postoperative intensive care unit .


Thirty patients with postoperative AT levels greater than 65 % were observed as controls .


Interleukin 6 ( a marker of inflammation ) , prothrombin fragment 1-2 ( a marker of thrombin generation ) , plasmin-antiplasmin complex ( a marker of fibrinolysis ) , and platelet factor 4 ( a marker of platelet activation ) were measured at six different times .


Compared with the no AT group and control patients , patients receiving AT showed significantly higher AT values until 48 hours after the last administration .


Analysis of variance for repeated measures showed a significant effect of study treatment in reducing prothrombin fragment 1-2 ( p = 0.009 ; interaction with time sample , p = 0.006 ) and plasmin-antiplasmin complex ( p < 0.001 ; interaction with time sample , p < 0.001 ) values but not interleukin 6 ( p = 0.877 ; interaction with time sample , p = 0.521 ) and platelet factor 4 ( p = 0.913 ; interaction with time sample , p = 0.543 ) .


No difference in chest tube drainage , reopening for bleeding , and blood transfusion was observed .


Antithrombin administration in patients with low AT activity after surgery with cardiopulmonary bypass reduces postoperative thrombin generation and fibrinolysis with no effects on platelet activation and inflammatory response .


We evaluated patients at tertiary [ both percutaneous coronary intervention ( PCI ) and coronary artery bypass grafting ( CABG ) capable ] and primary hospitals in the EARLY-ACS trial .


Early invasive management is recommended for high-risk non-ST-segment elevation acute coronary syndromes .


We evaluated outcomes in 9,204 patients presenting to : tertiary sites , primary sites with transfer to tertiary sites ( `` transferred '' ) and those who remained at primary sites ( `` non-transfer '' ) .


There were 348 tertiary ( n = 7,455 patients ) and 89 primary hospitals [ n = 1,749 patients ( 729 transferred ; 1,020 non-transfer ) ] .


Significant delays occurred in time from symptom onset to angiography ( 49 hr ) , PCI ( 53h ) , and CABG ( 178 hr ) for transferred patients ( P < 0.001 ) .


Non-transfer patients had less 30-day death/myocardial infarction [ 9.4 % vs. 11.7 % ( tertiary ) ; adjusted odds ratio ( OR ) : 0.78 ( 0.62-0 .97 ) , P = 0.026 ] ; transferred ( 14.0 % ) and tertiary patients were similar [ adjusted OR : 1.23 ( 0.98-1 .53 ) , P = 0.074 ] .


Non-transfer patients had lower 1-year mortality [ 4.3 % vs. 6.3 % ( tertiary ) ; adjusted hazard ratio ( HR ) : 0.64 ( 0.47-0 .87 ) , P = 0.005 ] : there was no difference between transferred and tertiary patients [ 5.2 % vs. 6.3 % ; adjusted HR : 0.80 ( 0.58-1 .12 ) , P = 0.202 ] .


Despite similar rates of catheterization , GUSTO severe/moderate bleeding within 120 hr was less in non-transfer [ 3.1 % vs. 6.7 % ( tertiary ) ; adjusted OR : 0.47 ( 0.32-0 .68 ) , P < 0.001 ] , whereas transferred ( 6.1 % ) and tertiary patients were similar [ adjusted OR : 0.94 ( 0.68-1 .30 ) , P = 0.693 ] .


There was no difference in non-CABG bleeding .


Timely angiography and revascularization were often not achieved in transferred patients .


Non-transferred patients presenting to primary sites had the lowest event rates and the best long-term survival .


We hypothesized that a targeted temperature of 33 C as compared to that of 36 C would increase survival and reduce the severity of circulatory shock in patients with shock on admission after out-of-hospital cardiac arrest ( OHCA ) .


The recently published Target Temperature Management trial ( TTM-trial ) randomized 939 OHCA patients with no difference in outcome between groups and no difference in mortality at the end of the trial in a predefined subgroup of patients with shock at admission .


Shock was defined as a systolic blood pressure of < 90 mm Hg for > 30 min or the need of supportive measures to maintain a blood pressure 90 mmHg and/or clinical signs of end-organ hypoperfusion .


In this post hoc analysis reported here , we further analyzed the 139 patients with shock at admission ; all had been randomized to receive intervention at 33 C ( TTM33 ; n = 71 ) or 36 C ( TTM36 ; n = 68 ) .


Primary outcome was 180-day mortality .


Secondary outcomes were intensive care unit ( ICU ) and 30-day mortality , severity of circulatory shock assessed by mean arterial pressure , serum lactate , fluid balance and the extended Sequential Organ Failure assessment ( SOFA ) score .


There was no significance difference between targeted temperature management at 33 C or 36 C on 180-day mortality [ log-rank test , p = 0.17 , hazard ratio 1.33 , 95 % confidence interval ( CI ) 0.88-1 .98 ] or ICU mortality ( 61 vs. 44 % , p = 0.06 ; relative risk 1.37 , 95 % CI 0.99-1 .91 ) .


Serum lactate and the extended cardiovascular SOFA score were higher in the TTM33 group ( p < 0.01 ) .


We found no benefit in survival or severity of circulatory shock with targeted temperature management at 33 C as compared to 36 C in patients with shock on admission after OHCA .


Youths with a family history of alcohol and other drug use disorders ( FH + ) are at a greater risk of developing substance use disorders than their peers with no such family histories ( FH - ) , and this increased risk may be related to impaired maturation of forebrain circuitry .


FH + individuals have shown altered forebrain activity at rest and while performing cognitive tasks .


However , it is not fully understood how forebrain activity is altered in FH + individuals , and ultimately how these alterations may contribute to substance use disorder risk .


In this study , we tested 72 FH + and 32 FH - youths performing a go/no-go task and examined activations in blocks with only go trials ( Go Only ) , blocks with 50 % go and 50 % no-go trials ( Go/NoGo ) , and a contrast of those 2 blocks .


FH + youths had significantly greater cerebral activations in both the Go and Go/NoGo blocks than FH - youths in regions including the posterior cingulate/precuneus , bilateral middle/superior temporal gyrus , and medial superior frontal gyrus with no significant group differences in the subtraction between Go Only and Go/NoGo blocks .


Additionally , FH + youths had moderately slower reaction times on go trials in the Go Only blocks .


Our findings suggest that global activation increase in FH + youths are modulated by FH density and are not specific to the inhibitory components of the task .


This pattern of increased activations in FH + youths may be at least partially due to impaired forebrain white matter development leading to greater activations/less efficient neural communication during task performance .


Risk factors have been proposed for running injuries including ( a ) reduced muscular strength , ( b ) excessive joint movements and ( c ) excessive joint moments in the frontal and transverse planes .


To date , many running injury prevention programs have focused on a `` top down '' approach to strengthen the hip musculature in the attempt to reduce movements and moments at the hip , knee , and/or ankle joints .


However , running mechanics did not change when hip muscle strength increased .


It could be speculated that emphasis should be placed on increasing the strength of the ankle joint for a `` ground up '' approach .


Strengthening of the large and small muscles crossing the ankle joint is assumed to change the force distribution for these muscles and to increase the use of smaller muscles .


This would be associated with a reduction of joint and insertion forces , which could have a beneficial effect on injury prevention .


However , training of the ankle joint as an injury prevention strategy has not been studied .


Ankle strengthening techniques include isolated strengthening or movement-related strengthening such as functional balance training .


There is little knowledge about the efficacy of such training programs on strength alteration , gait or injury reduction .


Novice runners will be randomly assigned to one of three groups : an isolated ankle strengthening group ( strength , n = 40 ) , a functional balance training group ( balance , n = 40 ) or an activity-matched control group ( control , n = 40 ) .


Isokinetic strength will be measured using a Biodex System 3 dynamometer .


Running kinematics and kinetics will be assessed using 3D motion analysis and a force platform .


Postural control will be assessed by quantifying the magnitude and temporal structure of the center of pressure trace during single leg stance on a force platform .


The change pre - and post-training in isokinetic strength , running mechanics , and postural control variables will be compared following the interventions .


Injuries rates will be compared between groups over 6months .


Avoiding injury will allow individuals to enjoy the benefits of participating in aerobic activities and reduce the healthcare costs associated with running injuries .


Current Controlled Trial NCT01900262 .


Vitamin B12 deficiency causes neurologic and psychiatric disease , especially in older adults .


Subacute combined degeneration is characterized by damage to the posterior and lateral spinal cord affecting the corticospinal tract .


To test corticospinal tract projections using motor evoked potentials ( MEPs ) by transcranial magnetic stimulation ( TMS ) in asymptomatic older adults with low vitamin B12 ( B12 ) levels .


Cross-sectional study of 53 healthy older adults ( > 70 years ) .


MEPs were recorded in the abductor pollicis brevis and tibialis anterior muscles , at rest and during slight tonic contraction .


Central motor conduction time ( CMCT ) was derived from the latency of MEPs and peripheral motor conduction time ( PMCT ) .


Neurophysiological variables were analyzed statistically according to B12 status .


Median age was 74.33.6 years ( 58.5 % women ) .


Twenty-six out of the 53 subjects had low vitamin B12 levels ( B12 < 221pmol/l ) .


MEPs were recorded for all subjects in upper and lower extremities .


There were no significant differences in either latency or amplitude of MEPs and CMCT between low and normal B12 groups .


There was a significant PMCT delay in the lower extremities in the low B12 group ( p = 0.014 ) .


No subclinical abnormality of the corticospinal tract is detected in asymptomatic B12-deficient older adults .


The peripheral nervous system appears to be more vulnerable to damage attributable to this vitamin deficit .


The neurophysiological evaluation of asymptomatic older adults with lower B12 levels should be focused mainly in peripheral nervous system evaluation .


Uncontrolled hypertension ( HTN ) is a significant public health problem among blacks in the United States .


Despite the proven efficacy of therapeutic lifestyle change ( TLC ) on blood pressure ( BP ) reduction in clinical trials , few studies have examined their effectiveness in church-based settings-an influential institution for health promotion in black communities .


Using a cluster-randomized , 2-arm trial design , this study evaluates the effectiveness of a faith-based TLC intervention vs health education ( HE ) control on BP reduction among hypertensive black adults .


The intervention is delivered by trained lay health advisors through group TLC sessions plus motivational interviewing in 32 black churches .


Participants in the intervention group receive 11 weekly TLC sessions targeting weight loss , increasing physical activity , fruit , vegetable and low-fat dairy intake , and decreasing fat and sodium intake , plus 3 monthly individual motivational interviewing sessions .


Participants in the control group attend 11 weekly classes on HTN and other health topics delivered by health care experts .


The primary outcome is change in BP from baseline to 6 months .


Secondary outcomes include level of physical activity , percent change in weight , and fruit and vegetable consumption at 6 months , and BP control at 9 months .


If successful , this trial will provide an alternative and culturally appropriate model for HTN control through evidence-based lifestyle modification delivered in churches by lay health advisors .


The classification of clinical severity of Ebstein anomaly still remains a challenge .


The aim of this study was to focus on the interaction of the pathologically altered right heart with the anatomically-supposedly-normal left heart and to derive from cardiac magnetic resonance ( CMR ) a simple imaging measure for the clinical severity of Ebstein anomaly .


Twenty-five patients at a mean age of 2614 years with unrepaired Ebstein anomaly were examined in a prospective study .


Disease severity was classified using CMR volumes and functional measurements in comparison with heart failure markers from clinical data , ECG , laboratory and cardiopulmonary exercise testing , and echocardiography .


All examinations were completed within 24 hours .


A total right/left-volume index was defined from end-diastolic volume measurements in CMR : total right/left-volume index = ( RA + aRV + fRV ) / ( LA+LV ) .


Mean total right/left-volume index was 2.61.7 ( normal values : 1.10.1 ) .


This new total right/left-volume index correlated with almost all clinically used biomarkers of heart failure : brain natriuretic peptide ( r = 0.691 ; P = 0.0003 ) , QRS ( r = 0.432 ; P = 0.039 ) , peak oxygen consumption/kg ( r = -0.479 ; P = 0.024 ) , ventilatory response to carbon dioxide production at anaerobic threshold ( r = 0.426 ; P = 0.048 ) , the severity of tricuspid regurgitation ( r = 0.692 ; P = 0.009 ) , tricuspid valve offset ( r = 0.583 ; P = 0.004 ) , and tricuspid annular plane systolic excursion ( r = 0.554 ; P = 0.006 ) .


Previously described severity indices ( [ RA + aRV ] / [ fRV + LA+LV ] ) and fRV/LV end-diastolic volume corresponded only to some parameters .


In patients with Ebstein anomaly , the easily acquired index of right-sided to left-sided heart volumes from CMR correlated well with established heart failure markers .


Our data suggest that the total right/left-volume index should be used as a new and simplified CMR measure , allowing more accurate assessment of disease severity than previously described scoring systems .


This study sought to investigate the association of beta-blocker therapy at discharge with clinical outcomes in patients with ST-segment elevation myocardial infarction ( STEMI ) after primary percutaneous coronary intervention ( PCI ) .


Limited data are available on the efficacy of beta-blocker therapy for secondary prevention in STEMI patients .


Between November 1 , 2005 and September 30 , 2010 , 20,344 patients were enrolled in nationwide , prospective , multicenter registries .


Among these , we studied STEMI patients undergoing primary PCI who were discharged alive ( n = 8,510 ) .


We classified patients into the beta-blocker group ( n = 6,873 ) and no-beta-blocker group ( n = 1,637 ) according to the use of beta-blockers at discharge .


Propensity-score matching analysis was also performed in 1,325 patient triplets .


The primary outcome was all-cause death .


The median follow-up duration was 367 days ( interquartile range : 157 to 440 days ) .


All-cause death occurred in 146 patients ( 2.1 % ) of the beta-blocker group versus 59 patients ( 3.6 % ) of the no-beta-blocker group ( p < 0.001 ) .


After 2:1 propensity-score matching , beta-blocker therapy was associated with a lower incidence of all-cause death ( 2.8 % vs. 4.1 % , adjusted hazard ratio : 0.46 , 95 % confidence interval : 0.27 to 0.78 , p = 0.004 ) .


The association with better outcome of beta-blocker therapy in terms of all-cause death was consistent across various subgroups , including patients with relatively low-risk profiles such as ejection fraction > 40 % or single-vessel disease .


Beta-blocker therapy at discharge was associated with improved survival in STEMI patients treated with primary PCI .


Our results support the current American College of Cardiology/American Heart Association guidelines , which recommend long-term beta-blocker therapy in all patients with STEMI regardless of reperfusion therapy or risk profile .


Local anesthetic wound infiltration is widely used as an effective adjunct during multimodal postoperative pain management .


The aim of this study was to evaluate the effectiveness of continuous wound infusion of ropivacaine in postoperative pain relief , opioid sparing , incidence of nausea and vomiting , and bowel and liver function improvement in patients undergoing open hepatectomy .


Forty patients undergoing open hepatectomy were enrolled in this prospective , randomized , double-blinded , placebo-controlled trial .


Patients were divided into 2 groups : the 0.9 % saline continuous infusion group ( the control group ; n = 20 ) and the ropivacaine continuous infusion group ( the Ropi group ; n = 20 ) .


Outcomes measured postoperatively were pain score at rest and on movement , sufentanil consumption , incidence of nausea and vomiting , and sedation score across 48 postoperative hours .


Time to bowel recovery , liver function change , mean length of hospitalization , patient satisfaction , and other data after 48 postoperative hours were collected until hospital discharge .


Pain scores at rest were lower for the ropivacaine group and reached significance after 8 and 16 hours ( P < 0.01 ) .


Sufentanil consumption ( 41.5021.80 vs. 89.7035.22 g ; P < 0.01 ) after 48 hours , time to bowel recovery ( 1.800.70 vs. 3.151.04 d ; P < 0.01 ) , incidence of nausea and vomiting ( 1.750.72 vs. 2.400.68 ; P < 0.05 ) , and mean length of hospitalization ( 5.62.44 vs. 7.352.85 d ; P < 0.01 ) were significantly reduced , and the sedation score and liver function change were also comparable between the 2 groups .


There was no difference with respect to pain scores on movement , nor with respect to patient satisfaction .


Surgical wound infusion with ropivacaine after hepatectomy can improve pain relief at rest and accelerate recovery and discharge .


Tuberculosis ( TB ) is highly prevalent among HIV-infected people , including those receiving combination antiretroviral therapy ( cART ) , necessitating a well tolerated and efficacious TB vaccine for these populations .


We evaluated the safety and immunogenicity of the candidate TB vaccine M72/AS01 in adults with well controlled HIV infection on cART .


A randomized , observer-blind , controlled trial ( NCT00707967 ) .


HIV-infected adults on cART in Switzerland were randomized 3:1:1 to receive two doses , 1 month apart , of M72/AS01 , AS01 or 0.9 % physiological saline ( N = 22 , N = 8 and N = 7 , respectively ) and were followed up to 6 months postdose 2 ( D210 ) .


Individuals with CD4 cell counts below 200 cells/l were excluded .


Adverse events ( AEs ) including HIV-specific and laboratory safety parameters were recorded .


Cell-mediated ( ICS ) and humoral ( ELISA ) responses were evaluated before vaccination , 1 month after each dose ( D30 , D60 ) and D210 .


Thirty-seven individuals [ interquartile range ( IQR ) CD4 cell counts at screening : 438-872 cells/l ; undetectable HIV-1 viremia ] were enrolled ; 73 % of individuals reported previous BCG vaccination , 97.3 % tested negative for the QuantiFERON-TB assay .


For M72/AS01 recipients , no vaccine-related serious AEs or cART-regimen adjustments were recorded , and there were no clinically relevant effects on laboratory safety parameters , HIV-1 viral loads or CD4 cell counts .


M72/AS01 was immunogenic , inducing persistent and polyfunctional M72-specific CD4 T-cell responses [ medians 0.70 % ( IQR 0.37-1 .07 ) at D60 ] and 0.42 % ( 0.24-0 .61 ) at D210 , predominantly CD40LIL-2TNF - , CD40LIL-2 and CD40LIL-2TNF-IFN - ] .


All M72/AS01 vaccines were seropositive for anti-M72 IgG after second vaccination until study end .


M72/AS01 was clinically well tolerated and immunogenic in this population , supporting further clinical evaluation in HIV-infected individuals in TB-endemic settings .


The aim of this study was to investigate whether remedial hydration ( RH ) reduces the incidence of contrast-induced nephropathy ( CIN ) and short-term adverse events in ST-elevation myocardial infarction ( STEMI ) patients undergoing primary percutaneous coronary intervention ( PCI ) .


A total of 216 consecutive STEMI patients were prospectively and randomly assigned into two groups : 108 patients in the RH group and 108 patients in the no RH ( control ) group .


The serum creatinine ( SCr ) and creatinine clearance ( CCr ) levels were measured on admission and at 24 , 48 and 72 hours after primary PCI .


The rates of CIN and short-term adverse events were analyzed for each group .


After surgery , the patients were categorized into four groups according to the Mehran risk score : low ( 5 , n = 98 ) , moderate ( 6-10 , n = 56 ) , high ( 11-15 , n = 40 ) or very high ( 16 , n = 22 ) .


The incidence of CIN in the RH group was lower than that observed in the control group ( 22/108 ; 20.4 % vs. 38/108 ; 35.2 % , p < 0.05 ) .


The subgroup analysis showed that the rate of CIN was lower in the moderate ( 6/29 ; 20.7 % vs. 13/30 ; 43.3 % , p < 0.10 ) and significantly lower in both the high ( 5/21 ; 23.8 % vs. 10/18 ; 55.6 % , p < 0.05 ) and very high score groups ( 3/12 ; 25.0 % vs. 8/12 ; 66.7 % , p < 0.05 ) among the RH patients compared to the controls .


At 24 , 48 and 72 hours after PCI , the patients in the RH group exhibited lower SCr levels and higher CCr levels than the patients in the control group ( both p < 0.05 ) .


A lower incidence of in-hospital clinical events was also observed in the RH group .


Remedial hydration decreases the occurrence of CIN and improves the short-term prognosis of STEMI patients undergoing primary PCI .


An increased production of oxidizing species related to reactive oral diseases , such as chronic apical periodontitis , could have systemic implications such as an increase in cardiovascular morbidity .


Based on this consideration , we conducted a prospective study to assess whether subjects affected by chronic periodontitis presented with higher values of oxidative stress than reference values before endodontic treatment , and whether endodontic treatment can reduce the oxidative imbalance and bring it back to normal in these subjects .


The authors recruited 2 groups of patients from private studies and dental clinics : these patients were recruited randomly .


The oxidative balance in both patients with chronic apical periodontitis ( CAP ) and healthy control patients was determined by measuring the oxidant status , using an identification of the reactive oxygen metabolites ( d-ROMs ) test , while the antioxidant status in these patients was determined using a biological antioxidant potential ( BAP ) test .


Both these tests were carried on plasma samples taken from enrolled patients .


Values were measured both before the endodontic treatment of the patients with chronic apical periodontitis , and 30 and 90 days after treatment , and compared to those obtained from healthy control patients .


It was found that , on recruitment , the patients with chronic apical periodontitis exhibited significantly higher levels of oxidative stress than control patients , as determined by the d-ROMs and BAP tests .


Furthermore , the d-ROMs test values were shown to decrease and the BAP test values to increase over time in patients with chronic apical periodontitis following endodontic therapy .


As the levels of oxidative stress in these patients tended to reduce and return to normal by 90 days following treatment .


This study has demonstrated a positive association between chronic apical periodontitis and oxidative stress .


Subjects affected by chronic apical periodontitis are exposed to a condition of oxidative stress , which is extremely dangerous to general health .


Moreover , one can infer from these findings that through proper endodontic therapy , a good oxidative balance can be restored , thereby avoiding the risk of contracting the abovementioned diseases .


Placebo effect has been largely studied and debated in medicine .


Research focused mainly on children and adults but not on newborns .


In osteopathy , few studies documented this effect and no research has been conducted in newborns .


To assess the presence of placebo effect in newborns using sham osteopathic manipulative treatment .


Randomized control trial .


Neonatal Intensive Care Unit in Italy .


Two groups ( 103 patients each ) of preterm infants aged 29-36 weeks without medical complications received routine pediatric care and osteopathic sham therapy was administrated to the study group only for the entire period of hospitalization .


Primary end point was the mean reduction of length of stay at discharge .


Secondary objective was the change in daily weight gain .


206 newborns entered the study .


No difference between sham and control group was found for the primary outcome length of stay ( 30.020.3 ; 28.818.9 ; p = 0.70 ) .


Multivariate analysis showed no difference between study and control group on length of stay .


A negative association was found for gestational age ( -2.33 ; 95 % CI -3.81 to -0.85 ; p = 0.002 ) , birth weight ( -0.01 ; 95 % CI -0.02 to -0.01 ; p < 0.001 ) and milk volume at study enrollment ( -0.02 ; 95 % CI -0.05 to -0.01 ; p = 0.01 ) .


To the best of our knowledge , this study is the first in the field showing no placebo effect on newborns .


Further discussions are opened concerning the age when placebo effect starts .


Clostridium difficile infection ( CDI ) is a leading cause of diarrhoea in health care settings with symptoms ranging from mild and self-limiting to life threatening .


SMT19969 is a novel , non-absorbable antibiotic currently under development for the treatment of CDI .


Here we report the results from a Phase I study .


A double-blind , randomized , placebo-controlled study assessing safety and tolerability of single and multiple oral doses of SMT19969 in healthy volunteers .


Pharmacokinetic assessments included blood and faecal sampling .


The effect of food on systemic exposure and analysis of the gut microbiota were also included .


Fifty-six healthy male subjects were enrolled .


Following single oral doses of up to 2,000 mg in the fasted state , plasma concentrations of SMT19969 were generally below the lower limit of quantification .


In the fed state levels ranged from 0.102 to 0.296 ng/mL after single dosing and after repeat dosing at Day 10 from 0.105 to 0.305 ng/mL .


Following single and multiple oral doses of SMT19969 , mean daily faecal concentrations increased with increasing dose level and were significantly above the typical MIC range for C. difficile ( 0.06-0 .5 g/mL ) .


At 200 mg BID , mean ( SD ) faecal concentrations of 1,466 ( 547 ) g/g and 1,364 ( 446 ) g/g were determined on days 5 and 10 of dosing respectively .


No notable metabolites were detected in faeces .


Overall , all doses of SMT19969 were well tolerated both as single oral doses or BID oral doses for 10 days .


The majority ( 88 % ) of adverse events ( AEs ) were classified as gastrointestinal disorders and were mild in severity , resolving without treatment .


The gut microbiota was analysed in the multiple dose groups with minimal changes observed in the bacterial groups analysed except for total clostridia which were reduced to below the limit of detection by day 4 of dosing .


Oral administration of SMT19969 was considered safe and well tolerated and was associated with negligible plasma concentrations after single and multiple doses .


In addition , minimal disruption of normal gut microbiota was noted , confirming the highly selective spectrum of the compound .


These results support the further clinical development of SMT19969 as an oral therapy for CDI .


Current Controlled Trials .


ISRCTN10858225 .


While overall survival for most common cancers in Australia is improving , the rural-urban differential has been widening , with significant excess deaths due to lung , colorectal , breast and prostate cancer in regional Australia .


Internationally a major focus on understanding variations in cancer outcomes has been later presentation to healthcare and later diagnosis .


Approaches to reducing time to diagnosis of symptomatic cancer include public symptom awareness campaigns and interventions in primary care to improve early cancer detection .


This paper reports the protocol of a factorial cluster-randomised trial of community and general practice ( GP ) level interventions to reduce the time to diagnosis of cancer in rural Western Australia ( WA ) .


The community intervention is a symptom awareness campaign tailored for rural Australians delivered through a community engagement model .


The GP intervention includes a resource card with symptom risk assessment charts and local referral pathways implemented through multiple academic detailing visits and case studies .


Participants are eligible if recently diagnosed with breast , colorectal , lung or prostate cancer who reside in specific regions of rural WA with a planned sample size of 1350 .


The primary outcome is the Total Diagnostic Interval , defined as the duration from first symptom ( or date of cancer screening test ) to cancer diagnosis .


Secondary outcomes include cancer stage , healthcare utilisation , disease-free status , survival at 2 and 5years and cost-effectiveness .


Ethics approval has been granted by the University of Western Australia and from all relevant hospital recruitment sites in WA .


Results of this trial will be reported in peer-reviewed publications and in conference presentations .


Australian New Zealand Clinical Trials Registry ( ANZCTR ) .


ACTRN12610000872033 .


This study aimed to evaluate whether incidental CT findings of emphysema , airway thickening and bronchiectasis , as seen on CT scans performed for other non-pulmonary clinical indications , are associated with future acute exacerbations of COPD resulting in hospitalisation or death .


This multicentre prospective case-cohort study comprised 6406 subjects who underwent routine diagnostic chest CT for non-pulmonary indications .


Using a case-cohort approach , we visually graded CT scans from cases and a random sample of 10 % of the baseline cohort ( n = 704 ) for emphysema severity ( range 0-20 ) , airway thickening ( range 0-5 ) and bronchiectasis ( range 0-5 ) .


We used weighted Cox proportional hazards analysis to assess the independent association between CT findings and hospitalisation or death due to COPD exacerbation .


During a median follow-up of 4.4 years ( maximum 5.2 years ) , 338 COPD events were identified .


The risk of experiencing a future acute exacerbation of COPD resulting in hospitalisation or death was significantly increased in subjects with severe emphysema ( score 7 ) and severe airway thickening ( score 3 ) .


The respective HRs were 4.6 ( 95 % CI 3.0 to 7.1 ) and 5.9 ( 95 % CI 3.4 to 10.5 ) .


Severe bronchiectasis ( score 3 ) was not significantly associated with increased risk of adverse events ( HR 1.5 ; 95 % CI 0.9 to 2.5 ) .


Morphological correlates of COPD such as emphysema and airway thickening detected on CT scans obtained for other non-pulmonary indications are strong independent predictors of subsequent development of acute exacerbations of COPD resulting in hospitalisation or death .


To explore the feasibility of making a preoperative diagnosis of lung adenocarcinoma shown as ground-glass nodule ( GGN ) on computed tomography ( CT ) .


A total of 143 GGN lesions proved pathologically were divided randomly into A and B groups .


Then each group was further divided pathologically into preinvasive lesion , minimal invasive adenocarcinoma ( MIA ) and invasive adenocarcinoma ( IAC ) subgroups .


Group A ( n = 101 ) , size of lesion , proportion of ground glass opacity ( GGO ) composition of lesion , long diameter , longest diameter and size of solid component in lesion were measured on CT so as to establish the CT diagnostic standard of lung adenocarcinoma shown as GGN on CT. .


Group B ( n = 42 ) was employed to evaluate the accuracy of the above CT diagnostic standard .


SPSS 17.0 software was used for statistical analysis .


Significant statistic significance existed in all parameters among all groups ( P < 0.05 ) .


All parameters were correlated the pathologic type of lesion .


The differences were statistically significant ( P = 0.000 ) .


Through the receiver operating characteristic ( ROC ) curve , between groups of preinvasive lesion and MIA , each parameter had a medium diagnostic value of 0.70-0 .90 ; between groups of MIA and IAC , size of lesion and long diameter of solid component in lesion had a medium diagnostic value of 0.70-0 .90 , longest diameter of solid component , size of solid component in lesion and proportion of GGO composition of lesion had a high diagnostic value with an AUC of > 0.90 .


The CT diagnostic standard , derived from group A , was used to analyze the pathologic type of group B. And t no significant statistic significance existed between CT preoperative diagnosis and operative pathologic diagnosis ( P > 0.05 ) .


The correct diagnosis rates of size of lesion , proportion of GGO composition of lesion , long diameter , longest diameter and size of solid component in lesion were 71.43 % , 76.19 % , 90.05 % , 90.05 % and 88.10 % respectively .


Based upon size of lesion , proportion of GGO composition of lesion , long diameter , longest diameter and size of solid component in lesion , preoperative CT examination may be used to determine the pathological types of lung adenocarcinoma shown as GGN .


Tonsillectomy surgery is associated with severe postoperative pain that usually requires analgesics including opioids .


Pain control is still a big problem after tonsillectomy surgery .


We aimed to evaluate the efficacy of preemptive analgesia using montelukast for pediatric post-tonsillectomy pain management .


This is the first-time use of montelukast in post-tonsillectomy pain .


Double-blind , controlled-randomized study .


University teaching and research hospital .


A total of 60 children , aged 5 to 15 years , American Society of Anesthesiologist class I-II , scheduled for elective tonsillectomy were enrolled in this clinical trial study .


The patients were randomized into 2 groups : the montelukast group ( group M , n = 30 ) and control group ( group C , n = 30 ) .


Group M recieved an oral montelukast tablet and group C recieved placebo at 2400pm on the morning before surgery .


Post-tonsillectomy pain was evaluated with the Wong-Baker FACES Scale during the 24 hours after surgery .


Patients ' intraoperative hemodynamic parameters and intraoperative and postoperative complications were recorded .


There were statistically significant differences between group C and group M for Wong-Baker FACES pain rating scale scores ( P < .05 ) .


In the 24 hours after surgery , the total number of patients using rescue analgesics was higher in group C than in group M , and the difference was statistically significant ( P < .001 ) .


There was no significant difference in demographic parameters ( P > .05 ) .


There were no significant differences in postoperative nausea and vomiting , otalgia , trismus , fever , or halitosis between the groups ( P > .05 ) .


Preemptive montelukast can be used safely to reduce the serious pain caused by tonsillectomy in children .


Metastatic colon cancer patients are treated with the chemotherapy regimens , FOLFOX and FOLFIRI , in either order .


So far , we can not predict the response of chemotherapeutic agent , so it is necessary to find which regimen is adequate before starting chemotherapy .


Enrolled patients are randomized into either conventional treatment or planned treatment preceded by pretreatment genetic analysis .


Blood samples of patients in planned treatment group ( N = 53 ) were analyzed for the genetic polymorphism before selection of chemotherapeutic agents .


Target genes were XPD-751 , GSTP-1-105 , XRCC1-399 for oxaliplatin , UGT1A1 for irinotecan .


The response was measured by computed tomographic scan after completion of three cycles of chemotherapy .


Overall response rate was significantly higher in planned group ( 67.9 % vs. 46.3 % , P = 0.020 ) .


In FOLFOX group , response rate was significantly improved in the planned patients ( 77.1 % vs. 50 % , P = 0.018 ) .


In FOLFIRI group , the difference did n't reach statistical significance ( 50 % vs. 42.5 % , P = 0.776 ) .


We found significantly improved response rates in the chemotherapy of metastatic colon cancer by pretreatment genetic analysis , especially in FOLFOX group .


Cardiac arrest causes ischaemic brain injury .


Arterial carbon dioxide tension ( PaCO2 ) is a major determinant of cerebral blood flow .


Thus , mild hypercapnia in the 24 h following cardiac arrest may increase cerebral blood flow and attenuate such injury .


We describe the Carbon Control and Cardiac Arrest ( CCC ) trial .


The CCC trial is a pilot multicentre feasibility , safety and biological efficacy randomized controlled trial recruiting adult cardiac arrest patients admitted to the intensive care unit after return of spontaneous circulation .


At admission , using concealed allocation , participants are randomized to 24 h of either normocapnia ( PaCO2 35 to 45 mmHg ) or mild hypercapnia ( PaCO2 50 to 55 mmHg ) .


Key feasibility outcomes are recruitment rate and protocol compliance rate .


The primary biological efficacy and biological safety measures are the between-groups difference in serum neuron-specific enolase and S100b protein levels at 24 h , 48 h and 72 h. Secondary outcome measure include adverse events , in-hospital mortality , and neurological assessment at 6 months .


The trial commenced in December 2012 and , when completed , will provide clinical evidence as to whether targeting mild hypercapnia for 24 h following intensive care unit admission for cardiac arrest patients is feasible and safe and whether it results in decreased concentrations of neurological injury biomarkers compared with normocapnia .


Trial results will also be used to determine whether a phase IIb study powered for survival at 90 days is feasible and justified .


Australian New Zealand Clinical Trials Registry ACTRN12612000690853 .


For decades thiopental has been considered as the hypnotic drug of choice for intracranial surgery .


However , total intravenous anesthesia performed with thiopental is associated with delayed recovery , whereas early post-operative neurological evaluation is critical .


For this reason , target controlled infusion ( TCI ) of propofol is increasingly used for maintenance of anesthesia .


However , a thiopental TCI has never been assessed for this purpose .


We tested the hypothesis that a thiopental TCI provides an acceptable way to achieve early recovery compared to a propofol TCI during supratentorial surgery .


Eighty patients undergoing elective craniotomy for a supratentorial tumor were randomized to receive either a propofol TCI ( group P ) or a thiopental TCI ( group T ) .


Both groups received a sufentanil TCI and the bispectral index was monitored .


The primary end-point was time to tracheal extubation .


Secondary end-points were per - and post-operative hemodynamics as well as respiratory and recovery parameters .


Assessment of study end-points was performed by an intensive care specialist blinded ( like the patient ) to the received hypnotic .


Time to extubation was significantly ( P < 0.0001 ) shorter in group P ( median 149 minutes ; interquartile range 72-250 minutes ) than in group T ( median 453 minutes ; interquartile range 286-813 minutes ) .


Similarly , the recovery parameters were significantly better in group P than in group T.


There was no difference between groups in terms of patient characteristics and hemodynamic parameters .


Even with TCI and bispectral index monitoring , thiopental is associated with an inappropriate delayed recovery from supratentorial surgery compared to propofol TCI .


To investigate the effects of conservative therapy applied before arthroscopic subacromial decompression on the clinical outcome in patients with stage 2 shoulder impingement syndrome .


Sixty-eight patients having stage 2 shoulder impingement syndrome and treated with arthroscopic subacromial decompression were included in the study .


We divided these patients into 2 groups , whereby 32 ( 47 % ) patients received conservative therapy before arthroscopic subacromial decompression and 36 ( 53 % ) patients did not receive conservative therapy .


We compared both groups in terms of the the Constant , UCLA , and VAS scores for shoulder pain before and after arthroscopic subacromial decompression .


Constant , UCLA , and VAS scores were statistically significantly improved in both groups after arthroscopic subacromial decompression ( P < 0.001 ) .


Constant , UCLA , and VAS scores before arthroscopic subacromial decompression were statistically better in Group 1 than in Group 2 ( P < 0.001 ) .


No statistically significant difference was found between the groups in terms of Constant , UCLA , and VAS scores after arthroscopic subacromial decompression ( P > 0.05 ) .


Conservative therapy applied in patients with stage 2 shoulder impingement syndrome before arthroscopic subacromial decompression does not have a positive contribution on the clinical outcome after arthroscopic subacromial decompression .


Obstructive sleep apnea is associated with considerable health risks .


Although continuous positive airway pressure ( CPAP ) can mitigate these risks , effectiveness can be reduced by inadequate adherence to treatment .


We evaluated the clinical safety and effectiveness of upper-airway stimulation at 12 months for the treatment of moderate-to-severe obstructive sleep apnea .


Using a multicenter , prospective , single-group , cohort design , we surgically implanted an upper-airway stimulation device in patients with obstructive sleep apnea who had difficulty either accepting or adhering to CPAP therapy .


The primary outcome measures were the apnea-hypopnea index ( AHI ; the number of apnea or hypopnea events per hour , with a score of 15 indicating moderate-to-severe apnea ) and the oxygen desaturation index ( ODI ; the number of times per hour of sleep that the blood oxygen level drops by 4 percentage points from baseline ) .


Secondary outcome measures were the Epworth Sleepiness Scale , the Functional Outcomes of Sleep Questionnaire ( FOSQ ) , and the percentage of sleep time with the oxygen saturation less than 90 % .


Consecutive participants with a response were included in a randomized , controlled therapy-withdrawal trial .


The study included 126 participants ; 83 % were men .


The mean age was 54.5 years , and the mean body-mass index ( the weight in kilograms divided by the square of the height in meters ) was 28.4 .


The median AHI score at 12 months decreased 68 % , from 29.3 events per hour to 9.0 events per hour ( P < 0.001 ) ; the ODI score decreased 70 % , from 25.4 events per hour to 7.4 events per hour ( P < 0.001 ) .


Secondary outcome measures showed a reduction in the effects of sleep apnea and improved quality of life .


In the randomized phase , the mean AHI score did not differ significantly from the 12-month score in the nonrandomized phase among the 23 participants in the therapy-maintenance group ( 8.9 and 7.2 events per hour , respectively ) ; the AHI score was significantly higher ( indicating more severe apnea ) among the 23 participants in the therapy-withdrawal group ( 25.8 vs. 7.6 events per hour , P < 0.001 ) .


The ODI results followed a similar pattern .


The rate of procedure-related serious adverse events was less than 2 % .


In this uncontrolled cohort study , upper-airway stimulation led to significant improvements in objective and subjective measurements of the severity of obstructive sleep apnea .


( Funded by Inspire Medical Systems ; STAR ClinicalTrials.gov number , NCT01161420 . )


To identify facilitators and barriers to clinical trial implementation in Aboriginal health services .


Indepth interview study with thematic analysis .


Six Aboriginal community-controlled health services and one government-run service involved in the Kanyini Guidelines Adherence with the Polypill ( KGAP ) study , a pragmatic randomised controlled trial that aimed to improve adherence to indicated drug treatments for people at high risk of cardiovascular disease .


32 health care providers and 21 Aboriginal and Torres Strait Islander patients .


A fundamental enabler was that participants considered the research to be governed and endorsed by the local health service .


That the research was perceived to address a health priority for communities was also highly motivating for both providers and patients .


Enlisting the support of Aboriginal and Torres Strait Islander staff champions who were visible to the community as the main source of information about the trial was particularly important .


The major implementation barrier for staff was balancing their service delivery roles with adherence to often highly demanding trial-related procedures .


This was partially alleviated by the research team 's provision of onsite support and attempts to make trial processes more streamlined .


Although more intensive support was highly desired , there were usually insufficient resources to provide this .


Despite strong community and health service support , major investments in time and resources are needed to ensure successful implementation and minimal disruption to already overstretched , routine services .


Trial budgets will necessarily be inflated as a result .


Funding agencies need to consider these additional resource demands when supporting trials of a similar nature .


To compare the effect of incomplete caries removal ( ICR ) and indirect pulp capping ( IPC ) with calcium hydroxide ( CH ) or an inert material ( wax ) on color , consistency and contamination of the remaining dentin of primary molars .


This double-blind , parallel-design , randomized controlled trial included 30 children presenting one primary molar with deep caries lesion .


Children were randomly assigned after ICR to receive IPC with CH or wax .


All teeth were then restored with resin composite .


Baseline dentin color and consistency were evaluated after ICR , and dentin samples were collected for contamination analyses using scanning electron microscopy .


After 3 months , restorations were removed and the three parameters were re-evaluated .


In both groups , dentin became significantly darker after 3 months .


No cases of yellow dentin were observed after 3 months with CH compared to 33.3 % of the wax cases ( P < 0.05 ) .


A statistically significant difference over time was observed only for CH regarding consistency .


CH stimulated a dentin hardening process in a statistically higher number of cases than wax ( 86.7 % vs. 33.3 % ; P = 0.008 ) .


Contamination changed significantly over time in CH and wax without significant difference between groups .


It was concluded that CH and wax arrested the carious process of the remaining carious dentin after indirect pulp capping , but CH showed superior dentin color and consistency after 3 months .


In literature there is a general consensus that the use of the mirror improves proprioception .


During rehabilitation the mirror is an important instrument to improve stability .


In some sports , such as dancing , mirrors are widely used during training .


The purpose of this study is to evaluate the effectiveness of the use of a mirror on balance in young dancers .


Sixty-four young dancers ( ranging from 9-10 years ) were included in this study .


Thirty-two attending lessons with a mirror ( mirror - group ) were compared to 32 young dancers that attended the same lessons without a mirror ( non-mirror group ) .


Balance was evaluated by BESS ( Balance Error Scoring System ) , which consists of three stances ( double limb , single limb , and tandem ) on two surfaces ( firm and foam ) .


The errors were assessed at each stance and summed to create the two subtotal scores ( firm and foam surface ) and the final total score ( BESS ) .


The BESS was performed at recruitment ( T0 ) and after 6months of dance lessons ( T1 ) .


The repeated measures ANOVA analysis showed that for the BESS total score there is a difference due to the time ( F = 3.86 ; p < 0.05 ) .


No other differences due to the group or to the time of measurement were found ( p > 0.05 ) .


The analysis of the multiple regression model showed the influence of the values at T0 for every BESS items and the dominance of limb for stability on an unstable surface standing on one or two legs .


These preliminary results suggest that the use of a mirror in a ballet classroom does not improve balance acquisition of the dancer .


On the other hand , improvement found after 6months confirms that at the age of the dancers studied motor skills and balance can easily be trained and improved .


Long-term follow-up studies documenting maintenance of treatment effects are fewin adolescent anorexia nervosa ( AN ) .


This exploratory study reports relapse from full remission and attainment of remission during a 4-year open follow-up period using a convenience sample of a subgroup of 65 % ( n = 79 ) from an original cohort of 121 participants who completed a randomized clinical trial comparing family-based therapy ( FBT ) and adolescent-focused individual therapy ( AFT ) .


Follow-up assessments were completed up to 4years posttreatment ( average , 3.26 years ) .


Available participants completed the Eating Disorder Examination as well as self-report measures of self-esteem and depression at 2 to 4 years posttreatment .


Two participants ( 6.1 % ) relapsed ( FBT : n = 1 , 4.5 % ; AFT : n = 1 , 9.1 % ) , on average 1.98 years ( SD = 0.14 years ) after remission was achieved at 1-year follow-up .


Ten new participants ( 22.7 % ) achieved remission ( FBT : n = 1 , 5.9 % ; AFT : n = 9 , 33.3 % ) .


Mean time to remission for this group was 2.01 years ( SD = 0.82 years ) from 1-year follow-up .


There were no differences based on treatment group assignment in either relapse from full remission or new remission during long-term follow-up .


Other psychopathology was stable over time .


There were few changes in the clinical presentation of participants who were assessed at long-term follow-up .


These data suggest that outcomes are generally stable posttreatment regardless of treatment type once remission is achieved .


Clinical trial registration information-Effectiveness of Family-Based Versus Individual Psychotherapy in Treating Adolescents With Anorexia Nervosa ; http://www.clinicaltrials.gov/; NCT00149786 .


Coronary artery bypass grafting using the radial artery has , since the 1990s , gone through a revival .


Observational studies have indicated better long-term patency when using radial arteries .


Therefore , radial artery might be preferred especially in younger patients where long time patency is important .


During the last 10years different endoscopic techniques to harvest the radial artery have evolved .


Endoscopic radial artery harvest only requires a small incision near the wrist in contrast to open harvest , which requires an incision from the elbow to the wrist .


However , it is unknown whether the endoscopic technique results in fewer complications or a graft patency comparable to open harvest .


When the radial artery has been harvested , there are two ways to use the radial artery as a graft .


One way is sewing it onto the aorta and another is sewing it onto the mammary artery .


It is unknown which technique is the superior revascularisation technique .


The NEO Trial is a randomised clinical trial with a 22 factorial design .


We plan to randomise 300 participants into four intervention groups : ( 1 ) mammario-radial endoscopic group ; ( 2 ) aorto-radial endoscopic group ; ( 3 ) mammario-radial open surgery group ; and ( 4 ) aorto-radial open surgery group.The hand function will be assessed by a questionnaire , a clinical examination , the change in cutaneous sensibility , and the measurement of both sensory and motor nerve conduction velocity at 3months postoperatively .


All the postoperative complications will be registered , and we will evaluate muscular function , scar appearance , vascular supply to the hand , and the graft patency including the patency of the central radial artery anastomosis .


A patency evaluation by multi-slice computer tomography will be done at one year postoperatively.We expect the nerve conduction studies and the standardised neurological examinations to be able to discriminate differences in hand function comparing endoscopic to open harvest of the radial artery .


The trial also aims to show if there is any patency difference between mammario-radial compared to aorto-radial revascularisation techniques but this objective is exploratory .


ClinicalTrials.gov identifier : NCT01848886.Danish Ethics committee number : H-3-2012-116 .


Danish Data Protection Agency : 2007-58-0015 / jr. n :30 -0838 .


Knowledge of essential amino acid requirements in infants is important because excessive intake of protein can lead to increased long-term morbidity such as obesity .


A deficient intake may lead to suboptimal growth and impaired neurodevelopment .


The current recommended branched-chain amino acid requirements in infants aged 0-1 mo are based on the amino acid content of human milk .


We quantified the requirements for isoleucine , leucine , and valine for term neonates by using the indicator amino acid oxidation method with [ 1 - ( 13 ) C ] phenylalanine as the indicator .


Fully enterally fed term infants received randomly graded amounts of isoleucine ( 5-216 mg kg ( -1 ) d ( -1 ) ) , leucine ( 5-370 mg kg ( -1 ) d ( -1 ) ) , or valine ( 5-236 mg kg ( -1 ) d ( -1 ) ) as part of an elemental formula .


Data are expressed as means SDs .


Eighty-three Asian , term neonates ( mean SD birth weight : 3.3 0.4 kg ; gestational age : 39.4 1.3 wk ) were studied at a postnatal age of 13 5 d. Mean requirements for isoleucine , leucine , and valine ( measured in boys only ) were 105 mg kg ( -1 ) d ( -1 ) ( r ( 2 ) = 0.61 , P < 0.001 ) , 140 mg kg ( -1 ) d ( -1 ) ( r ( 2 ) = 0.26 , P < 0.01 ) , and 110 mg kg ( -1 ) d ( -1 ) ( r ( 2 ) = 0.35 , P = 0.001 ) , respectively .


Current human milk-based recommendations for isoleucine and valine in term infants aged 0-1 mo are correct .


However , the current recommendation for leucine ( 166 mg kg ( -1 ) d ( -1 ) ) is higher than the mean requirement of 140 mg kg ( -1 ) d ( -1 ) that we determined in this study .


This trial was registered at www.trialregister.nl as NTR1610 .


We wanted to confirm the benefit of mometasone furoate ( MF ) in preventing acute radiation reactions , as shown in a previous study ( Bostrm et al , Radiother Oncol 2001 ; 59:257 -265 ) .


The study was a double-blind comparison of MF with D ( Diprobase ) , administered daily from the start of radiation therapy for 5 weeks in patients receiving breast radiation therapy , 40 Gy in 2.67-Gy fractions daily over 3 weeks .


The primary endpoint was mean modified Radiation Therapy Oncology Group ( RTOG ) score .


Mean RTOG scores were significantly less for MF than for D ( P = .046 ) .


Maximum RTOG and mean erythema scores were significantly less for MF than for D ( P = .018 and P = .012 , respectively ) .


The Dermatology Life Quality Index ( DLQI ) score was significantly less for MF than for D at weeks 4 and 5 when corrected for Hospital Anxiety and Depression ( HAD ) questionnaire scores .


MF cream significantly reduces radiation dermatitis when applied to the breast during and after radiation therapy .


For the first time , we have shown a significantly beneficial effect on quality of life using a validated instrument ( DLQI ) , for a topical steroid cream .


We believe that application of this cream should be the standard of care where radiation dermatitis is expected .


To compare the interstage cardiac catheterization hemodynamic and angiographic findings between shunt types for the Pediatric Heart Network Single Ventricle Reconstruction trial .


The trial , which randomized subjects to a modified Blalock-Taussig shunt ( MBTS ) or right ventricle-to-pulmonary artery shunt ( RVPAS ) for the Norwood procedure , demonstrated the RVPAS was associated with a smaller pulmonary artery diameter but superior 12-month transplant-free survival .


We analyzed the pre-stage II catheterization data for the trial subjects .


The hemodynamic variables and shunt and pulmonary angiographic data were compared between shunt types ; their association with 12-month transplant-free survival was also evaluated .


Of 549 randomized subjects , 389 underwent pre-stage II catheterization .


A smaller size , lower aortic and superior vena cava saturation , and higher ventricular end-diastolic pressure were associated with worse 12-month transplant-free survival .


The MBTS group had a lower coronary perfusion pressure ( 27 vs 32 mm Hg ; P < .001 ) and greater pulmonary blood flow/systemic blood flow ratio ( 1.1 vs 1.0 , P = .009 ) .


A greater pulmonary blood flow/systemic blood flow ratio increased the risk of death or transplantation only in the RVPAS group ( P = .01 ) .


The MBTS group had fewer shunt ( 14 % vs 28 % , P = .004 ) and severe left pulmonary artery ( 0.7 % vs 9.2 % , P = .003 ) stenoses , larger mid-main branch pulmonary artery diameters , and greater Nakata indexes ( 164 vs 134 , P < .001 ) .


Compared with the RVPAS subjects , the MBTS subjects had more hemodynamic abnormalities related to shunt physiology , and the RVPAS subjects had more shunt or pulmonary obstruction of a severe degree and inferior pulmonary artery growth at pre-stage II catheterization .


A lower body surface area , greater ventricular end-diastolic pressure , and lower superior vena cava saturation were associated with worse 12-month transplant-free survival .


It has been hypothesized that the development of diabetic polyneuropathy ( DPN ) is due to swelling of the nerve , as well as thickening and stiffening of the surrounding ligaments , causing chronic compression of nerves .


We aimed to examine the effect of surgical decompression of the tibial nerve on the mean cross-sectional area ( CSA ) .


We performed a randomized controlled trial of 42 subjects with painful DPN diagnosed using the Diabetic Neuropathy Score .


A computer randomized for the surgery arm of the study .


A control group consisting of 38 healthy subjects was included .


An experienced sonographer measured the CSA and thickness-to-width ( T/W ) ratio of the tibial nerve , as well as the thickness of the flexor retinaculum .


CSA is significantly larger in patients with painful DPN ( 8.4 3.9 mm ( 2 ) ) than in control subjects ( 6.4 1.3 mm ( 2 ) ) , P = 0.007 .


The T/W ratio in patients with painful DPN is 0.64 and in control subjects 0.59 , P = 0.03 .


Patients with DPN have a significantly thicker retinaculum ( 1.07 mm ) than control subjects ( 0.84 mm ) , P < 0.001 .


Mean follow-up was 28.2 weeks ( range 23-45 ) .


Difference between baseline and follow-up in the operated leg was 1.49 mm ( 2 ) and in the control leg 1.81 mm ( 2 ) , P = 0.674 .


Decompression of the tibial nerve does not result in a significant difference between baseline and follow-up in CSA using ultrasound between the operated and control leg .


Ultrasound measurements show a significantly increased CSA , a significantly thicker retinaculum , and a significantly increased T/W ratio in patients with painful DPN compared with healthy control subjects .


Clinical trial reg .


no .


NTR2344 , www.trialregister.nl .


A community-based randomized trial was conducted in Costa Rica to evaluate the HPV-16 / 18 AS04-adjuvanted vaccine ( NCT00128661 ) .


The primary objective was to evaluate efficacy of the vaccine to prevent cervical intraepithelial neoplasia 2 or more severe disease ( CIN2 + ) associated with incident HPV-16 / 18 cervical infections .


Secondary objectives were to evaluate efficacy against CIN2 + associated with incident cervical infection by any oncogenic HPVs and to evaluate duration of protection against incident cervical infection with HPV-16 / 18 .


Vaccine safety and immunogenicity over the 4-year follow-up were also evaluated .


We randomized ( 3727 HPV arm ; 3739 control arm ) , vaccinated ( HPV-16 / 18 or Hepatitis A ) and followed ( median 53.8 months ) 7466 healthy women aged 18-25 years .


5312 women ( 2635 HPV arm ; 2677 control arm ) were included in the according to protocol analysis for efficacy .


The full cohort was evaluated for safety .


Immunogenicity was considered on a subset of 354 ( HPV-16 ) and 379 ( HPV-18 ) women .


HPV type was assessed by PCR on cervical specimens .


Immunogenicity was assessed using ELISA and inhibition enzyme immunoassays .


Disease outcomes were histologically confirmed .


Vaccine efficacy and 95 % confidence intervals ( 95 % CI ) were computed .


Vaccine efficacy was 89.8 % ( 95 % CI : 39.5-99 .5 ; N = 11 events total ) against HPV-16 / 18 associated CIN2 + , 59.9 % ( 95 % CI : 20.7-80 .8 ; N = 39 events total ) against CIN2 + associated with non-HPV-16 / 18 oncogenic HPVs and 61.4 % ( 95 % CI : 29.5-79 .8 ; N = 51 events total ) against CIN2 + irrespective of HPV type .


The vaccine had an acceptable safety profile and induced robust and long-lasting antibody responses .


Our findings confirm the high efficacy and immunogenicity of the HPV-16 / 18 vaccine against incident HPV infections and cervical disease associated with HPV-16 / 18 and other oncogenic HPV types .


These results will serve as a benchmark to which we can compare future findings from the ongoing extended follow-up of participants in the Costa Rica trial .


Registered with clinicaltrials.gov : NCT00128661 .


There is a long-held concept among spine surgeons that endoscopic lumbar discectomy procedures are reserved for small-contained disc herniation ; 8-year follow-up has not been reported .


The purpose of this study is to assess microendoscopic discectomy ( MED ) in patients with large uncontained lumbar disc herniation ( the antero-posterior diameter of the extruded fragment is 6-12 mm or more on axial cuts of MRI ) and report long-term outcome .


One hundred eighty-five patients with MED or standard open discectomy underwent follow-up for 8 years .


Primary ( clinical ) outcomes data included Numerical Rating Scale ( NRS ) for back and leg symptoms and Oswestry Disability Index ( ODI ) to quantify pain and disability , respectively .


Secondary ( objective ) outcomes data included operative time , blood loss , postoperative analgesics , length of hospital stay , time to return to work , reoperation and complication rate , patient satisfaction index ( PSI ) , and modified ( MacNab ) criteria .


At the end of the follow-up , the leg pain relief was statistically significant for both groups .


NRS back pain , ODI , PSI and MacNab criteria showed significant deterioration for control group .


Secondary outcomes data of MED group were significantly better than the control group .


Large , uncontained , lumbar disc herniations can be sufficiently removed using MED which is an effective alternative to open discectomy procedures with remarkable long-term outcome .


Although the neurological outcome of the two procedures is the same , the morbidity of MED is significantly less than open discectomy .


Maximum benefit can be gained if we adhere to strict selection criteria .


The optimum indication is single - or multi-level radiculopathy secondary to a single-level , large , uncontained , lumbar disc herniation .


Heart failure ( HF ) patients suffer from frequent and repeated hospitalizations , causing a substantial economic burden on society .


Hospitalizations can be reduced considerably by better compliance with self-care .


Home telemonitoring has the potential to boost patients ' compliance with self-care , although the results are still contradictory .


A randomized controlled trial was conducted in order to study whether the multidisciplinary care of heart failure patients promoted with telemonitoring leads to decreased HF-related hospitalization .


HF patients were eligible whose left ventricular ejection fraction was lower than 35 % , NYHA functional class 2 , and who needed regular follow-up .


Patients in the telemonitoring group ( n = 47 ) measured their body weight , blood pressure , and pulse and answered symptom-related questions on a weekly basis , reporting their values to the heart failure nurse using a mobile phone app .


The heart failure nurse followed the status of patients weekly and if necessary contacted the patient .


The primary outcome was the number of HF-related hospital days .


Control patients ( n = 47 ) received multidisciplinary treatment according to standard practices .


Patients ' clinical status , use of health care resources , adherence , and user experience from the patients ' and the health care professionals ' perspective were studied .


Adherence , calculated as a proportion of weekly submitted self-measurements , was close to 90 % .


No difference was found in the number of HF-related hospital days ( incidence rate ratio [ IRR ] = 0.812 , P = .351 ) , which was the primary outcome .


The intervention group used more health care resources : they paid an increased number of visits to the nurse ( IRR = 1.73 , P < .001 ) , spent more time at the nurse reception ( mean difference of 48.7 minutes , P < .001 ) , and there was a greater number of telephone contacts between the nurse and intervention patients ( IRR = 3.82 , P < .001 for nurse-induced contacts and IRR = 1.63 , P = .049 for patient-induced contacts ) .


There were no statistically significant differences in patients ' clinical health status or in their self-care behavior .


The technology received excellent feedback from the patient and professional side with a high adherence rate throughout the study .


Home telemonitoring did not reduce the number of patients ' HF-related hospital days and did not improve the patients ' clinical condition .


Patients in the telemonitoring group contacted the Cardiology Outpatient Clinic more frequently , and on this way increased the use of health care resources .


Clinicaltrials.gov NCT01759368 ; http://clinicaltrials.gov/show/NCT01759368 ( Archived by WebCite at http://www.webcitation.org/6UFxiCk8Z ) .


Probiotics help maintain balance in composition of the gut microbiota , and have been considered as a potential treatment for obesity .


This study was conducted in order to assess the effects of probiotics when combined with herbal medicine in treatment of obesity .


Probiotics were tested for the ability to modulate gut microbiota , gut permeability , and endotoxin level , which may have correlation with factors involved in obesity .


A randomized , double-blind , placebo controlled study was conducted , in which patients with higher BMI ( > 25kg/m ( 2 ) ) and waist circumference ( > 85cm ) were enrolled and randomly assigned to receive Bofutsushosan with either probiotics or placebo capsules for a period of eight weeks .


Assessment of body composition parameters , metabolic biomarkers , endotoxin level , gut permeability , and fecal bacteria in stool was performed at baseline and at week 8 .


The study was registered at the Clinical Research Information Service , approved by the Korea National Institute of Health ( KCT0000386 ) .


Although both groups showed a significant reduction in weight and waist circumference ( p = 0.000 ) , no significant differences in body composition and metabolic markers were observed .


In correlation analysis , change in body composition showed positive correlation with endotoxin level ( r = 0.441 , p < 0.05 for BW ; and r = 0.350 , p < 0.05 for fat mass ) and the population of gut Lactobacillus plantarum ( r = 0.425 , p < 0.05 for BW ; and r = 0.407 , p < 0.05 for BMI ) .


The Gram negative bacterial population in gut also exhibited positive correlation with changes in body composition ( WC ) and total cholesterol level ( r = 0.359 , and 0.393 , for the former and later parameters , respectively , p < 0.05 for both ) .


While , the profile of gut Bifidobacterium breve population showed negative correlation with endotoxin level ( r = -0.350 , p < 0.05 ) .


Correlations between gut microbiota and change in body composition indicate that probiotics may influence energy metabolism in obesity .


Correlation between endotoxin level and weight reduction indicates that probiotics may play an important role in prevention of endotoxin production , which can lead to gut microbiota dysbiosis associated with obesity .


The objective of this study is to analyze the effects of a 12-week indoor intermittent training program on lung function , physical capacity , body composition and quality of life in children with asthma .


Participants were randomized in an experimental group ( EG , 58 children , age = 11.551.01 years ) and in a control group ( CG , 47 children , age = 11.511.42 years ) .


The training program was conducted indoors and consisted of alternating high - and low-intensity stimuli , for three sessions of 60min/week , for 12 weeks .


Physical exercise and sports activities were organized to follow the criteria of the American College of Sports Medicine ( 1999 ) and previous interventions ' studies .


In EG , there was a significant improvement ( p < 0.05 ) in FEV1 , FEV6 , 6MWT , handgrip strength , CMJ and flexibility .


Reductions in BMI and fat mass as well as an increase in quality of life were all shown .


The dyspnea index decreased significantly and there were no episodes of EIA .


There is a significant positive correlation ( p < 0.01 ) between the FEV1 with handgrip strength and 6MWT and a negative correlation with fat mass .


An indoor intermittent training program with these characteristics has improved lung function , physical capacity , body composition and quality of life in children with asthma .


These training adaptations are particularly relevant for those patients suffering from asthma as a regular physical exercise routine will greatly improve their quality of life .


To observe the efficacy of catgut implantation at back-shu points in treatment of mild perimenopausal depression of kidney , deficiency and liver stagnation syndrome and analyze its essential function on target symptoms .


Forty-five cases were randomized into a catgut implantation group ( 23 cases ) and atid acupuncture group ( 22 cases ) .


In the catgut implantation group , catguts were implanted at Shenshu ( BL 23 ) , Ganshu ( BL 18 ) , Xinshu ( BL 15 ) , Pishu ( BL 20 ) , etc. , once every week .


In the acupuncture group , the conventional acupuncture was applied to the same acupoints as the catgut implantation group , once every two days .


The : treatment of 4 weeks made one session , and continuous 2 sessions were required .


The efficacy was evaluated in , 2 sessions .


The follow-up started in the 12th week .


Before treatment , after treatment and in the follow-up period , Kupperman score and the total score in Hamilton depression scale ( HAMD ) , as well as the factor score were observed in the patients separately .


Kupperman score , the total HAMD score and the scores in the items of anxiety/somatization , retardation , sleep disorder and cognitive disorder after treatment were all reduced significantly as compared with those before treatment in the two groups ( P < 0.01 , P < 0.05 ) .


In the follow-up period , the difference in Kupperman was not significant in comparison with that after treatment in the catgut implantation : group ( P > 0.05 ) .


The total HAMD score and sleep disorder were reduced significantly as compared with those after treatment in the catgut implantation group ( both P < 0.01 ) ; in the acupuncture group , Kupperman score , the total HAMD score and sleep disorder were all increased as compared with those after treatment ( all P < 0.05 ) .


In ; the catgut implantation group , the total HAMD score was lower than that in the acupuncture group ( P < 0.05 ) , and the scores in the items of retardation and sleep disorder were reduced significantly as compared with those in the acupuncture group ( both P < 0.01 ) .


The catgut implantation at back-shu points alleviates perimenopasual sympton is in patients of mild perimenopausal depression of kidney deficiency and liver stagnation syndrome .


This therapy effectively relieves depressive disorders by regulating the target symptoms such as anxiety / somatization , retardation , sleep disorder and cognitive ' disorder .


The long-term efficacy of this therapy is better than the conventional acupuncture .


Up to 25 % of patients who undergo a percutaneous coronary intervention show some limitation in the use of drug-eluting stents .


The aim of this study was to evaluate if titanium-nitride-oxide-coated stents could be a good alternative to everolimus-eluting stents in diabetic patients .


A total of 173 diabetic patients with lesions at moderate risk of restenosis ( exclusion criteria : diameter < 2.5 mm or length > 28 mm in vessels < 3mm , chronic occlusion ) were randomized to a titanium group ( 83 patients ) or an everolimus group ( 90 patients ) .


Baseline characteristics were well balanced ; 28.3 % of patients were insulin dependent .


At 1 year , the incidence of major adverse cardiac events ( death , nonfatal myocardial infarction , stroke , or repeat target vessel revascularization ) was significantly higher in the titanium group than in the everolimus group ( total , 14.5 % vs 4.4 % ; P = .02 ; noninsulin-dependent subgroup , 9.7 % vs 3.2 % ; P = .14 ; insulin-dependent subgroup , 28.6 % vs 7.1 % ; P = .04 ) .


The incidence of death , nonfatal myocardial infarction , stroke , or any revascularization was 16.9 % in the titanium group and 7.8 % in the everolimus group ( P = .06 ) .


Target lesion and vessel revascularizations occurred in 8.4 % compared with 3.3 % ( P = .15 ) and in 13.3 % compared with 3.3 % ( P = .01 ) in the titanium and everolimus groups , respectively .


Angiographic follow-up at 9 months showed significantly less late lumen loss in the everolimus group ( in-segment , 0.52 [ standard deviation , 0.58 ) mm vs -0.05 [ 0.32 ] mm ; in-stent , 0.76 [ 0.54 ] mm vs 0.13 [ 0.31 ] mm ; P < .0001 ) .


The everolimus-eluting stent is superior to the titanium stent for clinical and angiographic end points in diabetic patients with lesions at moderate risk of restenosis .


To evaluate the safety of the fixed combination of ibuprofen and famotidine compared with ibuprofen alone from two 24-week , multicenter , double-blind trials designed to evaluate the comparative incidence of endoscopically documented upper gastrointestinal ulcers and a 28-week double-blind extension study .


Safety was analyzed by pooling data from the two double-blind trials and the follow-on study .


Safety was assessed by monitoring the incidence , causality , and severity of adverse events ( AEs ) .


In the pivotal efficacy and safety trials , discontinuation rates due to any cause and dyspepsia were significantly lower for the ibuprofen/famotidine combination versus ibuprofen alone .


Other than dyspepsia , gastrointestinal and cardiovascular AEs of special interest were similar .


Events judged to be treatment related were significantly lower with the ibuprofen/famotidine combination ( 20.6 % vs. 25 % ) .


In the safety extension population , there were no differences in the discontinuation rates and the reporting of AEs or serious AEs ( SAEs ) between the two groups .


Gastrointestinal-related events were similar between the groups .


Incidence of cardiovascular-related AEs of special interest were 11 % ( ibuprofen/famotidine ) and 2 % ( ibuprofen ) ( p = 0.06 ) , possibly due to a higher number of rheumatoid arthritis patients in the combination group .


Of these , 80 % were reports of hypertension ( 8 % ibuprofen/famotidine vs. 2 % ibuprofen ) .


Three cases of hypertension in the ibuprofen/famotidine group were considered treatment related .


The probability of a cardiovascular event decreased during days 112-167 of treatment and remained low with continued treatment .


One-year safety data from two pivotal trials and a long-term extension study indicate that the ibuprofen/famotidine combination demonstrates a favorable gastrointestinal safety profile and more patients continued on therapy compared to ibuprofen alone .


No new safety signals have been identified .


These data offer additional evidence supporting a new therapeutic option to improve gastrointestinal safety and adherence for patients who require long-term ibuprofen .


To compare the effects of volume-controlled ventilation ( VCV ) and pressure-controlled volume-guaranteed ( PCV-VG ) mode during one-lung ventilation ( OLV ) on circulation , pulmonary function and lung injury .


2012 February to 2013 March in Ningbo No2 .


Hospital cardiothoracic surgery , 30 patients aged 52 to 76 years ( ASA grade II-III ) undergoing elective thoracoscopic lobectomy were randomly divided into VCV group and PCV-VG group , with 15 cases in each group .


After anesthesia induction and endotracheal intubation , endobronchial blocker was inserted to start OLV .


Heart rate ( HR ) , mean arterial pressure ( MAP ) , measured tidal volume ( TV ) , peak airway pressure ( Ppeak ) , airway resistance ( Raw ) , chest compliance ( Cdyn ) and the end-tidal carbon dioxide pressure ( PetCO ( 2 ) ) were recorded at the time point of 15 minutes after turning to the lateral position , 15 minutes and 60 minutes after OLV , and 15 minutes after the resumption of two lung ventilation .


In the meanwhile , arterial blood gas analysis was conducted to measure indicators of pH , oxygen tension ( PaO ( 2 ) ) and carbon dioxide partial pressure ( PaCO ( 2 ) ) .


Blood was drawn before induction , 1 hour after OLV and 1 hour after the end of surgery , and the concentration of interleukin-6 ( IL-6 ) and tumor necrosis factor-alpha ( TNF - ) were detected by enzyme-linked immunosorbent assay ( ELISA ) .


HR , MAP , TV , PetCO ( 2 ) , pH and PaCO ( 2 ) in two groups at the time point of 15 minutes after turning to the lateral position , 15 minutes and 60 minutes after OLV , and 15 minutes after the resumption of two lung ventilation showed no significant difference ( P > 0.05 ) .


At the point of 15 minutes after turning to the lateral position and 15 minutes after two lung ventilation , Ppeak and Cdyn of two groups were significantly different ( P < 0.05 ) ( Ppeak :16 3 cmH ( 2 ) O , 16 3 cmH ( 2 ) O for VCV group and 14 2 cmH ( 2 ) O , 14 2 cmH ( 2 ) O for PCV-VG group ; Cdyn : 43.5 5.9 ml/cmH ( 2 ) O , 43.8 6.7 ml/cmH2O for VCV group and 49.7 7.1 ml/cmH ( 2 ) O , 53.3 9.6 ml/cmH ( 2 ) O for PCV-VG group ) .


Compared with VCV group , PCV-VG group showed a lower Ppeak 15 minutes and 60 minutes after OLV [ ( 17 2 cmH ( 2 ) O ) vs ( 22 4 cmH ( 2 ) O ) and ( 18 4 cmH ( 2 ) O ) vs ( 23 3 cmH ( 2 ) O ) with a higher Cdyn at the same point ( 38.6 6.3 ml/cmH ( 2 ) O ) vs ( 29.6 3.2 ml/cmH ( 2 ) O ) and 37.3 6.0 ml/cmH ( 2 ) O ) vs ( 30.3 3.8 ml/cmH ( 2 ) O ) ] ( P < 0.01 ) .


Compared with VCV group,IL-6 and TNF - of PCV-VG group 1 hour after OLV and 1 hour after the end of surgery were significantly lower ( P < 0.01 ) ( IL-6 : 52.32 3.59 vs 62.65 4.17 pg/ml and 63.57 4.98 vs 82.38 4.10 pg/ml ; TNF - : 3.23 0.27 vs 4.19 0.38 pg/ml and 4.01 0.28 vs. 5.49 0.31 pg/ml ) .


During one-lung ventilation in thoracoscopic lobectomy , PCV-VG mode has a competitive advantage over VCV mode in terms of pulmonary function and lung protection .


We compared the recovery profile of propofol and sevoflurane when used for maintenance of anesthesia in elective day care operative procedures .


One hundred ASA physical status I and II patients , aged between 18 and 50 years , were randomly assigned to receive either propofol-nitrous oxide or sevoflurane-nitrous oxide maintenance of anesthesia .


Early and intermediate recovery in terms of cognitive and ambulatory functions was recorded .


Psychomotor testing , in the form of Trieger dot test and digit symbol substitution test , were performed before surgery and in the post-anesthesia care unit at 15 min , 30 min , 1 h , 2 h , and 4 h following nitrous oxide switch-off to evaluate intermediate recovery .


There were no significant differences in recovery of early cognitive functions between the two groups , except that patients in the sevoflurane group were more responsive at around 10 min following nitrous oxide switch-off and `` recalled address '' earlier than patients in the propofol group .


There was no significant difference in between the two groups with regard to `` home-readiness . ''


Recovery from sevoflurane anesthesia , especially with regard to cognitive functions , may be slightly faster than from propofol , but the difference is not sufficiently significant to affect the time to `` home-readiness '' in patients undergoing day care surgery .


Vertigo imposes considerable health restrictions with significant impact on the patient 's quality of life .


The most effective antivertigo agent is undetermined thus far .


This study was performed to assess whether promethazine has superior vertigo reduction compared with lorazepam in ED patients .


In this randomized , double-blind , parallel group trial 184 patients were assigned ( 1:1 ratio ) to receive either promethazine , 25 mg intravenously , or lorazepam , 2 mg intravenously .


Primary endpoint was mean change in vertigo intensity at 2 hours measured using visual analog scale ( VAS ) .


Secondary endpoints were mean change in nausea score , need for second dose of study medications , and adverse events ( AEs ) .


Promethazine was associated with significantly more reduction ( 46.5 mm ) in vertigo than lorazepam ( 25.7 mm , p < 0.001 ) .


Mean change in nausea score 2 hours after drug injection on the VAS was 28.7 mm for promethazine and 22.8 for lorazepam ( p = 0.002 ) .


The most frequently reported AEs were lethargy ( 14.1 % in lorazepam group , 4.3 % in promethazine group , p = 0.013 ) and drowsiness ( 10.8 % for promethazine , 2.1 % for lorazepam , p = 0.017 ) .


Our study demonstrated the evidence that promethazine is superior to lorazepam in management of peripheral vertigo and vertigo-related nausea in ED adults .


During lower limb lengthening , distraction-induced muscle pain and surrounding joint contractures are frustrating complications for which few effective treatments are available .


We evaluated Botulinum Toxin Type A ( BtX-A ) injection in the calf muscles during human tibial distraction osteogenesis .


We hypothesized that it may decrease calf pain and increase ROM of the surrounding joints by reducing muscle stiffness .


Between April 2010 and January 2011 , we evaluated 36 patients undergoing bilateral tibia lengthening who met prespecified inclusion criteria .


All patients underwent stature lengthening with lengthening over a nail or lengthening and then nailing .


BtX-A ( 200IU ) was injected at the calf muscle only in one leg for each patient and the same amount of sterile normal saline was injected into the other leg as a control .


Selection of the leg receiving the toxin was randomized .


Clinical evaluation included a VAS score for calf pain and measurement of ROM of the knees and ankles and calf circumference , with evaluations performed in a double-blinded manner .


Side-to-side differences were analyzed until the end of consolidation phase .


Minimum followup was 24months ( mean , 30months ; range , 24-39months ) .


The distraction rate and the final length gain were similar in the treated and control limbs .


A priori power analysis suggested that 34 legs were required to achieve statistical significance of 0.05 with 80 % of power to detect a 50 % difference in treatment effect between treatment and control groups .


There were no differences in calf pain , knee and ankle ROM , and maximal calf circumferences between the two legs at each time point .


Local injection of 200IU BtX-A at the human calf muscle does not appear to reduce calf pain or help enhance ROM of the knee and ankle during tibial lengthening .


However , the small sample size provided sufficient power to detect only relatively large clinical effects ; future , larger trials will be needed to determine whether smaller differences are present .


Level II , therapeutic study .


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


To assess potential of preoperative therapy with local steroid and non-steroid anti-inflammatory drugs ( SAIDs and NSAIDs ) for prolonging the hypotensive effect of trabeculectomy .


A total of 80 patients with primary open-angle glaucoma planed for trabeculectomy were randomized into 4 groups of 20 each : 3 groups that differed in the studied drug ( nepafenac , dexamethasone , or their non-fixed combination ) and a control group with no preoperative therapy .


The patients instilled 1 drop of either drug b.i.d. for 2 weeks before the surgery and were examined each day of the first week and then at weeks 1 , 2 , 4 and months 3 , 6 , and 12 .


The rate of postoperative surgical and medical interventions ( needling , needling revision , hypotensive therapy ) was used for outcome evaluation .


Postoperative needling was required in 50 % of the controls , 35 % of the NSAIDs and 30 % of the SAIDs patients as well as 20 % the combination-therapy patients .


Needling revision had to be performed in 10 % of patients from the control group and 5 % of patients from the NSAIDs group .


Patients from the steroid and combination-therapy groups had no need in needling procedure .


Further hypotensive therapy was required in 50 % of the control group , 35 % of the NSAIDs group , 25 % of the SAIDs group and 20 % of the combination-therapy group .


During the first postoperative year complete success of the treatment was achieved in 50 % of the controls , 65 % of the NSAIDs patients , 75 % of the SAIDs patients , and 80 % of those under combination therapy .


Qualified success during the same period was achieved in 100 % of cases .


Preoperative local anti-inflammatory therapy helped to increase the one-year complete success rate after trabeculectomy as compared with the controls .


The most significant hypotensive effect was noted in the combination-therapy group ( 80 % ) , less significant -- in the steroid and non-steroid monotherapy groups ( 75 % and 65 % correspondingly ) .


A negative correlation was noted between the use of nepafenac and dexamethasone and other measures aimed at increasing the hypotensive effect of glaucoma surgery .


Case-control study ; ecological study .