Both groups received same rehabilitation program and procedures after surgery , except KT group also received KT applications throughout all rehabilitation period .


Postoperative pain , edema , restoration of the operated knee flexion and extension were evaluated .


The chosen level of significance was P < 0.05 ; in evaluation power of the test 0.2 .


Groups were homogenous to sex , age , BMI , comorbidities , preoperative knee flexion/extension impairment , preoperative pain intensity , anaesthesia , prosthesis implanted ( P > 0.05 ) .


In both groups postoperative pain decreased significantly during rehabilitation period , however less pain was found in KT group from the second postoperative week till the end of inpatient rehabilitation ( 28th postoperative day ) ( P < 0.05 ; 0.2 ) .


Postoperative edema was less intense and subsided more quickly in KT group as well ( P < 0.05 ; 0.2 ) .


No difference was found in improvement of knee flexion ( P > 0.05 ) .


Operated knee extension was found better in KT group then in control at the end of in-patient rehabilitation ( P < 0.05 ; 0.2 ) .


KT was well tolerated by patients .


KT technique appeared to be beneficial for reducing postoperative pain , edema , improving knee extension in early postoperative rehabilitation period .


This finding implies for health care professionals working in the field of physical medicine and rehabilitation that Kinesio Taping method is safe and can be used as additional rehabilitation means for patients after TKR .


A pair of simulated driving experiments studied the effects of cognitive load on drivers ' lane-keeping performance .


Cognitive load while driving often reduces the variability of lane position .


However , there is no agreement as to whether this effect should be interpreted as a performance loss , consistent with other effects of distraction on driving , or as an anomalous performance gain .


Participants in a high-fidelity driving simulator performed a lane-keeping task in lateral wind , with instructions to keep a steady lane position .


Under high load conditions , participants performed a concurrent working memory task with auditory stimuli .


Cross-spectral analysis measured the relationship between wind force and steering inputs .


Cognitive load reduced the variability of lane position and increased the coupling between steering wheel position and crosswind strength .


Although cognitive load disrupts driver performance in a variety of ways , it produces a performance gain in lane keeping.This effect appears to reflect drivers ' efforts to protect lateral control against the risk of distraction , at the apparent neglect of other elements of driving performance .


Results may inform educational efforts to help drivers understand the risks of distraction and the inadequacies of compensatory driving strategies .


Setting a target quit date ( TQD ) is often an important component in smoking cessation treatment , but ambiguity remains concerning the optimal timing ( ie , quitting spontaneously versus delaying to prepare ) .


We examined four questions about the timing of TQDs and smoking outcomes in secondary analyses of The iQUITT Study , a randomized trial of Internet and telephone treatment for cessation : ( 1 ) What are the characteristics of TQDs set using an online interactive quit date tool ?


, ( 2 ) What are the characteristics of individuals who use a quit date tool and do they differ from those who do not ?


, ( 3 ) Are there differences in smoker characteristics , treatment utilization , and cessation outcomes based TQD timing ?


, and ( 4 ) Is maintenance of an initial TQD predictive of abstinence or do changes to TQDs lead to cessation ?


A total of 825 adult current cigarette smokers were randomized to enhanced Internet or enhanced Internet plus telephone counseling .


Latency to TQD in days was calculated as the date difference between the initial TQD and enhanced Internet registration ; prospective TQD setters were stratified into four latency groups ( 0 , 1-14 , 15-28 , 29 + days ) .


Baseline variables , website utilization , and 3-month cessation outcomes were examined between prospective TQD groups .


Desire and confidence to quit , number of TQDs , and website logins were tested as predictors of 30-day point prevalence abstinence ( ppa ) at 3 months ( responder-only analyses ) .


Classification and regression tree ( CART ) analysis explored interactions among baseline variables , website utilization , and latency to TQD as predictors of 30-day ppa .


There were few baseline differences between individuals who used the quit date tool and those who did not .


Prospective TQDs were set as follows : registration day was 17.1 % ( 73/427 ) , 1-14 days was 37.7 % ( 161/427 ) , 15-28 days was 18.5 % ( 79/427 ) , and 29 + days was 26.7 % ( 114/427 ) .


Participants with a TQD within 2 weeks had higher baseline self-efficacy scores but did not differ on smoking variables .


Individuals whose TQD was the same day as registration had the highest logins , page views , number of TQDs set using the tool , and messages sent to other members .


Logistic regression revealed a significant interaction between number of TQDs and website logins for 30-day ppa ( P = .005 ) .


Among those with high logins , 41.8 % ( 33/79 ) with 1 TQD were abstinent versus 25.9 % ( 35/135 ) with 2 + TQDs .


Logins and self-efficacy predicted 30-day ppa in the CART model .


TQD timing did not predict cessation outcomes in standard or exploratory analyses .


Self-efficacy and an apparent commitment to an initial TQD were the components most highly related to abstinence but only via interactions with website utilization .


Findings highlight the importance of feeling efficacious about handling specific smoking situations and engaging with treatment .


Additional research focused on increasing engagement in Web-based cessation studies is needed .


ClinicalTrials.gov : NCT00282009 ; http://clinicaltrials.gov/show/NCT00282009 ( Archived by WebCite at http://www.webcitation.org/6Kt7NrXDl ) .


To compare the effectiveness and patient preference of different routes of misoprostol administration before operative hysteroscopy in premenopausal women .


Randomized , controlled trial .


University hospital .


One hundred sixty women undergoing operative hysteroscopy .


Patients were randomly assigned to receive 400 g misoprostol orally ( n = 40 ) , sublingually ( n = 40 ) , or vaginally ( n = 40 ) before operative hysteroscopy ; the control group ( n = 40 ) did not receive any cervical priming agent .


Preoperative cervical width , adverse effects , and patient preference .


The mean ( SD ) cervical widths for the oral , sublingual , vaginal , and control groups were 7.621.81 mm , 7.581.77 mm , 7.602.15 mm , and 5.652.12 mm , respectively , which was statistically significant .


Time to cervical dilatation was also significantly longer in the control group than in the other three groups .


Misoprostol-related adverse effects and hysteroscopy-related complications were comparable among the four study groups .


Of all 160 subjects , 132 ( 82 % ) preferred the oral route for misoprostol administration to the sublingual or vaginal routes , or had no preference .


All orally , sublingually , and vaginally administrated misoprostol is equally effective in inducing proper cervical priming before operative hysteroscopy .


Considering patient preference , oral administration may be the optimal route for misoprostol administration .


NCT01805115 .


To evaluate and determine the effectiveness of surgical excision , aspiration and injection in the treatment of symptomatic ganglions .


The prospective randomized control trial based on non-probability convenience sampling was conducted at the Department of Surgery , Combined Military Hospital , Sialkot , from June 2007 to August 2010 , and at the Department of Surgery , Islam Teaching Hospital , Sialkot , from September 2010 to December 2012 .


The last patient was included in June 2012 .


Adult patients referred by general practitioners with ganglia of wrist , ankle and knee were included .


All the patients were offered treatment options of intralesional steroid injection or excision of ganglion.The study population was distributed in two groups : Group I opted for aspiration and injection treatment , while Group II went for surgical treatment .


A minimum follow-up of six months was mandatory for inclusion in the study .


Data was compared and analyzed using SPSS version 22 .


The study had 173 patients with 187 ganglia .


Group I had 143 ( 76.4 % ) patients , while Group II had 44 ( 23.3 % ) .


In the short term , 82 ( 57.3 % ) of the patients achieved complete resolution after one episode of aspiration and injection , and success rate after second injection repeated after 3 weeks was 116 ( 81 % ) .


Overall success rate of aspiration and injection of Triamcinolone acetonide six months after the treatment was 116 ( 81 % ) .


On the surgical side the success rate was 41 ( 93 % ) .


Complications like pain , joint stiffness and ugly scar were few and not significant .


Comparison of failure rates of the two groups ( 19 % vs 7 % ) showed significant difference ( p < 0.028 ) .


In symptomatic ganglia , surgical excision was a better treatment option as the failure rate was less compared to injection-aspiration .


The injection treatment should be offered to those who are not willing for surgery , but they should be properly counselled about the chances of failure .


Parkinson 's disease is a common movement disorder affecting approximately 127,000 people in the UK , with an estimated two thirds having speech-related problems .


Currently there is no preferred approach to speech and language therapy within the NHS and there is little evidence for the effectiveness of standard NHS therapy or Lee Silverman voice treatment .


This trial aims to investigate the feasibility and acceptability of randomizing people with Parkinson 's disease-related speech or voice problems to Lee Silverman voice treatment or standard speech and language therapy compared to a no-intervention control .


The PD COMM pilot is a three arm , assessor-blinded , randomized controlled trial .


Randomization will be computer-generated with participants randomized at a ratio of 1:1:1 .


Participants randomized to intervention arms will be immediately referred to the appropriate speech and language therapist .


The target population are patients with a confirmed diagnosis of idiopathic Parkinson 's disease who have problems with their speech or voice .


The Lee Silverman voice treatment intervention group will receive the standard regime of 16 sessions between 50 and 60minutes in length over four weeks , with extra home practice .


The standard speech and language therapy intervention group will receive a dose determined by patients ' individual needs , but not exceeding eight weeks of treatment .


The control group will receive standard care with no speech and language therapy input for at least six months post-randomization .


Outcomes will be assessed at baseline ( pre-randomization ) and post - randomization at three , six , and 12months .


The outcome measures include patient-reported voice measures , quality of life , resource use , and assessor-rated speech recordings .


The recruitment aim is at least 60 participants over 21months from 11 sites , equating to at least 20 participants in each arm of the trial .


This trial is ongoing and recruitment commenced in May 2012 .


This study will provide information on the feasibility and acceptability of randomizing participants to different speech and language therapies or control/deferred treatment .


The findings relating to recruitment , treatment compliance , outcome measures , and effect size will inform a future phase III randomized controlled trial .


International Standard Randomised Controlled Trial Number Register : ISRCTN75223808 registered 22 March 2012 .


To compare the effects of neuromuscular exercise ( NEXA ) and quadriceps strengthening ( QS ) on the knee adduction moment ( an indicator of mediolateral distribution of knee load ) , pain , and physical function in patients with medial knee joint osteoarthritis ( OA ) and varus malalignment .


One hundred patients with medial knee pain , mostly moderate-to-severe radiographic medial knee OA , and varus malalignment were randomly allocated to one of two 12-week exercise programs .


Each program involved 14 individually supervised exercise sessions with a physiotherapist plus a home exercise component .


Primary outcomes were peak external knee adduction moment ( 3-dimensional gait analysis ) , pain ( visual analog scale ) , and self-reported physical function ( Western Ontario and McMaster Universities Osteoarthritis Index ) .


Eighty-two patients ( 38 [ 76 % ] of 50 in the NEXA group and 44 [ 88 % ] of 50 in the QS group ) completed the trial .


There was no significant between-group difference in the change in the peak knee adduction moment ( mean difference 0.13 Nm / [ body weight height ] % [ 95 % confidence interval ( 95 % CI ) -0.08 , 0.33 ] ) , pain ( mean difference 2.4 mm [ 95 % CI -6.0 , 10.8 ] ) , or physical function ( mean difference -0.8 units [ 95 % CI -4.0 , 2.4 ] ) .


Neither group showed a change in knee moments following exercise , whereas both groups showed similar significant reductions in pain and improvement in physical function .


Although comparable improvements in clinical outcomes were observed with both neuromuscular and quadriceps strengthening exercise in patients with moderate varus malalignment and mostly moderate-to-severe medial knee OA , these forms of exercise did not affect the knee adduction moment , a key predictor of structural disease progression .


The purpose of this study was to evaluate the advantages of exenatide treatment on obesity and non-alcoholic fatty liver disease ( NAFLD ) with elevated liver enzymes in patients with type 2 diabetes ( T2D ) .


A total of 60 newly diagnosed patients with obesity , NAFLD with elevated liver enzymes and T2D were included in the study .


The patients were randomly divided into two groups .


The exenatide treatment group ( n = 30 ) were treated with exenatide and insulin glargine , and the intensive insulin therapy group ( n = 30 ) were treated with insulin aspart and insulin glargine for 12weeks .


Selected clinical characteristics were determined , and ultrasonography was performed at both baseline and 12weeks following treatment .


At baseline , the clinical characteristics were matched between the two groups .


After 12weeks , fasting blood glucose ( FBG ) , postprandial blood glucose ( PBG ) , glycosylated haemoglobin ( HbA1c ) , total cholesterol ( TC ) , triglyceride ( TG ) and total bilirubin levels were significantly decreased in the two groups ( p < 0.001 ) .


Body weight and waist circumference were significantly decreased in the exenatide group but increased in the intensive insulin group ( p < 0.001 ) .


The levels of alanine aminotransferase ( ALT ) , aspartate aminotransferase ( AST ) and - glutamyl transpeptidase ( GGT ) in the exenatide group were significantly lower than in the intensive insulin group ( p < 0.001 ) .


The mean body weight change correlated with the levels of ALT , AST and GGT change ( ALT , r = 0.761 ; AST , r = 0.733 ; GGT , r = 0.752 ; p < 0.001 ) .


Moreover , the reversal rate of fatty liver was significantly higher in the exenatide group ( 93.3 % ) than the intensive insulin group ( 66.7 % ) ( p < 0.01 ) .


Exenatide has a better hepatic-protective effect than intensive insulin therapy and perhaps represents a unique option for adjunctive therapy for patients with obesity , non-alcoholic fatty liver disease with elevated liver enzymes and T2D .


This study sought to determine the frequency and impact of coronary calcification among patients undergoing percutaneous coronary intervention ( PCI ) for acute coronary syndromes ( ACS ) .


Small studies in patients with stable coronary artery disease have suggested a worse prognosis after PCI of calcified compared with noncalcified lesions .


Little is known about the impact of coronary calcification on outcomes after PCI for patients presenting with non-ST-segment elevation and ST-segment elevation ACS .


Data from 6,855 patients presenting with ACS in whom PCI was performed were pooled from 2 large-scale randomized , controlled trials , ACUITY ( Acute Catheterization and Urgent Intervention Triage Strategy ) and HORIZONS-AMI ( Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction ) .


One-year outcomes were analyzed according to the severity of PCI target lesion calcification ( none/mild , moderate , or severe ) as assessed by an independent angiographic core laboratory .


Target lesion calcification was severe in 402 patients ( 5.9 % ) , moderate in 1,788 ( 26.1 % ) , and none/mild in 4,665 ( 68.1 % ) .


Moderate/severe target lesion calcification was more frequent in older patients , men , hypertensive patients , and those presenting with ST-segment elevation myocardial infarction ( STEMI ) .


The unadjusted 1-year rates of death , cardiac death , definite stent thrombosis , and ischemic target lesion revascularization ( TLR ) and target vessel revascularization were significantly increased in patients with moderate/severe target lesion calcification .


By multivariable analysis , the presence of moderate/severe target lesion calcification was an independent predictor of 1-year definite stent thrombosis ( hazard ratio [ HR ] : 1.62 ; 95 % confidence interval [ CI ] : 1.14 to 2.30 ; p = 0.007 ) and ischemic TLR ( HR :1.44 ; 95 % CI : 1.17 to 1.78 ; p = 0.0007 ) .


Moderate/severe lesion calcification was relatively frequent in patients with non-ST-segment elevation ACS and STEMI and was strongly predictive of stent thrombosis and ischemic TLR at 1 year .


( Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes [ ACS ] ; NCT00093158 ; Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction ; NCT00433966 ) .


The potential epidemiological impact of isoniazid preventive therapy ( IPT ) , delivered at levels that could be feasibly scaled up among people living with HIV ( PLHIV ) in modern , moderate-burden settings , remains uncertain .


We used routine surveillance and implementation data from a cluster-randomized trial of IPT among HIV-infected clinic patients with good access to antiretroviral therapy in Rio de Janeiro , Brazil , to populate a parsimonious transmission model of tuberculosis ( TB ) / HIV .


We modeled IPT delivery as a constant process capturing a proportion of the eligible population every year .


We projected feasible reductions in TB incidence and mortality in the general population and among PLHIV specifically at the end of 5 years after implementing an IPT program .


Data on time to IPT fit an exponential curve well , suggesting that IPT was delivered at a rate covering 20 % ( 95 % confidence interval : 16 % to 24 % ) of the 2500 eligible individuals each year .


By the end of year 5 after modeled program rollout , IPT had reduced TB incidence by 3.0 % [ 95 % uncertainty range ( UR ) : 1.6 % to 7.2 % ] in the general population and by 15.6 % ( 95 % UR : 15.5 % to 36.5 % ) among PLHIV .


Corresponding reductions in TB mortality were 4.0 % ( 95 % UR : 2.2 % to 10.3 % ) and 14.3 % ( 14.6 % to 33.7 % ) .


Results were robust to wide variations in parameter values on sensitivity analysis .


TB screening and IPT delivery can substantially reduce TB incidence and mortality among PLHIV in urban , moderate-burden settings .


In such settings , IPT can be an important component of a multi-faceted strategy to feasibly reduce the burden of TB in PLHIV .


To investigate in a randomized , double-blind design , cumulative effects of anodal tDCS on EEG oscillations and neuropsychological tests among patients with traumatic brain injury ( TBI ) undergoing subacute neurorehabilitation .


Twenty-six patients were randomly assigned to active ( n = 13 ) or sham ( n = 13 ) tDCS groups .


EEGs were recorded at 6 different time points , assessing both immediate and cumulative effects of tDCS on EEG oscillations .


Twenty minute sessions of 1mA anodal stimulation to the left dorsolateral prefrontal cortex ( F3 , cathode placed at right supraorbital site , Fp2 ) , were provided on 10 consecutive days .


Neuropsychological tests were administered before and after the series of tDCS sessions .


Theta was significantly reduced for active tDCS patients following the first tDCS session .


Delta decreased and alpha increased , both significantly , for the active tDCS group after 10 consecutive tDCS sessions .


No significant changes were seen for sham group .


Decreases in delta were significantly correlated with improved performance on neuropsychological tests for the active tDCS group to far greater degree than for the sham group .


Participants in the active tDCS group who had excess slow EEG activity in their initial recordings showed greater improvement on neuropsychological tests than other groups .


Results suggest that 10 anodal tDCS sessions may beneficially modulate regulation of cortical excitability for patients with TBI .


EEG-guided tDCS warrants further investigation as a potential intervention for TBI during subacute neurorehabilitation .


This study aimed at assessing the effects of a self-regulation-based brief physical activity program for patients suffering from unexplained chronic fatigue , the `` 4-STEPS to control your fatigue program '' .


A 12-week randomized controlled trial was conducted .


Adult patients meeting the CDC criteria for idiopathic chronic fatigue were randomized to either the control condition ( standard care ) or the intervention condition ( 4-STEPS ) .


The 4-STEPS was based on self-regulation principles and consisted of motivational interviewing and self-regulation skills training .


All patients were assessed at baseline and post-treatment ( 12 weeks ) for fatigue severity ( primary outcome ) and impact , physical activity ( leisure time physical activity , number of daily steps and personal activity goal progress ) , health-related quality of life , somatic distress and psychological distress ( depression and anxiety ) .


Ninety-one patients ( 45 intervention and 46 control patients ) received the allocated intervention .


At post-treatment , statistical analysis revealed a significant difference for subjective experience of fatigue ( 4.73 points ; g = 0.51 ) in favour of the intervention group .


Mixed design ANCOVAs showed a significant effect of the 4-STEPS on fatigue severity , leisure time physical activity , personal activity goal progress and health-related quality of life .


No significant effects were found for number of daily steps and somatic and psychological distress .


The 4-STEPS program has significant beneficial effects at post-treatment .


This brief self-regulation-based intervention looks promising for the management of unexplained chronic fatigue .


ISRCTN70763996 .


Patients undergoing coronary artery bypass grafting ( CABG ) are still at significant risk for postoperative major adverse cardiac and cerebrovascular events ( MACCEs ) .


Recent clinical evidence shows that cardioprotection in patients receiving a chronic statin treatment can be `` recaptured '' by a high-dose statin therapy given shortly before an ischemia-reperfusion sequence .


Evaluation of this novel therapeutic approach in the setting of CABG seems promising because myocardial ischemia-reperfusion injury plays a pivotal role in poor clinical outcomes that may be improved by a simple preoperative statin recapture treatment .


The investigator-initiated StaRT-CABG trial is a multicenter , randomized , double-blinded , 2-parallel group controlled clinical study in 2,630 patients .


The trial aims to evaluate whether a high-dose statin recapture therapy given shortly before CABG reduces the incidence of MACCE at 30 days after surgery ( primary composite outcome : all-cause mortality , nonfatal myocardial infarction , and cerebrovascular events ) .


Consenting patients who are on chronic statin therapy before surgery will be randomized to receive either oral statin reloading therapy or matching placebo 12 and 2 hours before CABG .


Key secondary end points include enzymatic myocardial injury ; new-onset atrial fibrillation ; length of stay in the intensive care unit and hospital ; need for repeat coronary revascularization at 30 days ; and , finally , all-cause mortality at 12 months after surgery .


The StaRT-CABG trial is expected to provide highly relevant clinical data on the efficacy of this novel therapeutic approach to optimize the care for patients with coronary artery disease undergoing CABG .


Mumps , a communicable , acute and previously well-controlled disease , has had recent and occasional resurgences in some areas .


A randomized , double-blind , controlled and multistep phase I study of an F-genotype attenuated mumps vaccine produced in human diploid cells was conducted .


A total of 300 subjects were enrolled and divided into 4 age groups : 16-60 years , 5-16 years , 2-5 years and 8-24 months .


The groups were immunized with one injection per subject .


Three different doses of the F-genotype attenuated mumps vaccine , A ( 3.5 0.25 logCCID50 ) , B ( 4.25 0.25 logCCID50 ) and C ( 5.0 0.25 logCCID50 ) , as well as a placebo control and a positive control of a licensed A-genotype vaccine ( S79 strain ) were used .


The safety and immunogenicity of this vaccine were compared with those of the controls .


The safety evaluation suggested that mild adverse reactions were observed in all groups .


No serious adverse event ( SAE ) was reported throughout the trial .


The immunogenicity test showed a similar seroconversion rate of the neutralizing and ELISA antibody in the 2 - to 5-year-old and 8 - to 24-month-old groups compared with the seroconversion rate in the positive control .


The GMT of the neutralizing anti-F-genotype virus antibodies in the vaccine groups was slightly higher than that in the positive control group .


The F-genotype attenuated mumps vaccine evaluated in this clinical trial was demonstrated to be safe and have effective immunogenicity vs. control .


This study addressed the problem of evaluating the effectiveness of two protocols of physiotherapy for functional recovery after stroke .


In particular , the study explored the use of Functional Principal Component Analysis ( FPCA ) , a multivariate data analysis in order to assess and clarify the process of regaining independence after stroke .


A randomized double-blind controlled trial was performed .


Thirteen subjects with residual hemiparesis after a single stroke episode were measured in both in - and outpatient settings at a district hospital .


All subjects were able to walk before suffering the stroke and were hemodynamically stable within the first week after stroke .


Control and target groups were treated with conventional physiotherapy for stroke , but specific techniques were added for treatment of the target group depending on patients ' functional levels.Independence level was assessed with the Barthel Index ( BI ) throughout 7 evolution stages ( hemodynamic stability , beginning of standing , beginning of physical therapy sessions in the physiotherapy ward and monthly assessment for 6 months after stroke ) .


FPCA was applied for data analysis .


Statistically significant differences were found in the dynamics of the recovery process between the two physiotherapy protocols .


The target group showed a trend of improvement six months after stroke that was not present in the control group .


FPCA is a method which may be used to provide greater insight into the analysis of the rehabilitation process than that provided by conventional parametric methods .


So , by using the whole curves as basic data parameters , subtle differences in the rehabilitation process can be found.FPCA represents a future aid for the fine analysis of similar physiotherapy techniques , when applied in subjects with a huge variability of functional recovery , as in the case of post-stroke patients .


There is a growing interest in food constituents that could reduce intestinal glucose absorption to prevent overshooting plasma glucose and insulin levels in patients with prediabetes and diabetes mellitus type 2 .


We here demonstrate that an extract and individual polyphenols from apple diminish sodium-coupled glucose transporter 1 ( SGLT1 ) mediated glucose uptake in vitro and in vivo .


Inhibition of transport of sugars by SGLT1 was shown in Xenopus oocytes and in mice jejunal segments .


Strongest inhibition was observed for phlorizin with IC50 values for transport inhibition of 0.46 0.19 and 4.1 0.6 M in oocytes and intestinal segments , respectively .


An oral glucose tolerance test performed in volunteers with prior administration of the apple extract reduced venous blood glucose and plasma insulin levels , similar to findings obtained in C57BL/6N mice .


Analysis of human urine samples revealed that the extract increased modestly renal glucose loss that is most likely a result of inhibition of renal glucose reabsorption by phloretin derivatives found in plasma of the volunteers .


Although the apple extract substantially decreased intestinal glucose absorption in all test systems , the finding that there are systemic effects that relate to inhibition of glucose transport processes beyond the intestine addresses safety issues that need further exploitation .


Hypertrophic scar development after median sternotomy wound in cardiac surgery patients is quite common in surgical practice and becomes a major concern nowadays .


To compare cosmetic outcome between different suture materials and different suture techniques for skin closure in median sternotomy wound .


A randomized clinical trial was conducted in 80 patients who underwent cardiac surgery in Thammasat University Hospital , Thailand .


In respect of the materials and the techniques used to suture the skin , the patients were randomly allocated to four groups .


In group 1 , the skin was closed with subcuticular running 4-0 Poliglecaprone 25 ( Monocryl ) .


In group 2 , the skin was closed with subcuticular running 4-0 Polydioxanone ( PDS ) .


In group 3 , the skin was closed with subcuticular running 4-0 Poliglecaprone 25 ( Monocryl ) and running horizontal mattress 6-0 Nylon .


In group 4 , the skin was closed with subcuticular running 4-0 Polydioxanone ( PDS ) and running horizontal mattress 6-0 Nylon .


Postoperative evaluation was performed at 2 and 6 weeks , 3 and 6 months follow-up visits .


The scar was analyzed in three parts : upper , middle and lower one third of the sternal wound .


The outcome measures for surgical wound were width , height and overall appearance of the scar using the Vancouver scar scale ( VSS ) .


A linear visual analogue score ( VAS ) was preformed to assess pain and itch .


At 6 months , there were no significant differences between 4 groups ofpatients in every parameters ( width , height , VSS , pain score and itch score ) at three different wound sites ( upper middle and lower ) .


There was a statistically significant and progressive increase in scar stretching , height and total VSSfrom top to bottom of the sternum with the same pattern in all groups ofpatients ( p < 0.05 ) .


At 6 months , scar showed a statistically significant difference in width when compares to6 weeks and 3 months ( p < O. 001 ) .


Female had a statistically significant difference ofscar stretching at upper two third of the sternum ( p < 0.05 ) .


Female scar width was approximately 2folds greater than male patient .


Duringfollow-up in group 3 , two patients died postoperatively due to multi-organ failure and one patient developed wound infection .


There were no significant differences in cosmetic outcomes between different suture materials and different suture techniques .


This study was conducted to evaluate the effects of daily consumption of synbiotic bread on the metabolic status of patients with type 2 diabetes mellitus .


This randomized , double-blind , controlled clinical trial was performed in 81 diabetic patients .


The subjects were randomly assigned to consumption of synbiotic ( n = 27 ) , probiotic ( n = 27 ) , or control bread ( n = 27 ) for 8 weeks 3 times a day in a 40-gram package .


The synbiotic bread contained Lactobacillus sporogenes ( 1 10 ( 8 ) CFU ) and 0.07 g inulin per 1 g.


The probiotic bread contained L. sporogenes ( 1 10 ( 8 ) CFU per 1 g ) .


Fasting blood samples were taken at baseline and after an 8-week intervention for quantification of related factors .


Consumption of the synbiotic bread resulted in a significant reduction in serum insulin levels ( -3.2 5.4 vs. -0.3 3.4 and 0.6 4.7 IU/ml , respectively , p = 0.007 ) , homeostatic model assessment for insulin resistance scores ( -1.5 2.7 vs. -0.2 1.6 and 0.4 3.5 , respectively , p = 0.03 ) , and homeostatic model assessment -- cell function ( -7.2 16.3 vs. -0.7 10.8 and 0.7 8.2 , respectively , p = 0.04 ) compared to the probiotic and control breads .


We did not find any significant effect of synbiotic bread consumption on fasting plasma glucose , the quantitative insulin sensitivity check index , or serum hs-CRP levels compared to other breads .


Consumption of the synbiotic bread among diabetic patients had beneficial effects on insulin metabolism .


Hypertension is an important issue in Asia , responsible for up to 66 % of cardiovascular disease cases .


This randomized controlled trial subgroup analysis compared telmisartan 80 mg ( T80 ) / hydrochlorothiazide 25 mg ( H25 ) singlepill combination with T80 monotherapy , specifically in Chinese and Korean patients .


Patients with grade 2/3 hypertension were randomized to receive telmisartan 40 mg ( T40 ) / hydrochlorothiazide 12.5 mg ( H12 .5 ) combination or T40 monotherapy for one week , before uptitrating the dose to T80/H25 or T80 , respectively , for the remaining 6 weeks .


The primary endpoint was systolic blood pressure ( SBP ) mean change from baseline .


Secondary endpoints included mean diastolic blood pressure ( DBP ) change from baseline , and blood pressure ( BP ) goal achievement .


Adverse events were recorded .


Of a total 888 patients who were treated , efficacy analyses for Chinese and Korean patients included 127 patients treated with T80/H25 and 54 patients treated with T80 .


At week 7 , mean SBP reductions from baseline were -37.5 mmHg ( 1 mmHg = 0.133 kPa ) and -26.9 mmHg in the T80/H25 and T80 groups ( adjusted mean difference , -10.6 mmHg ; 95 % confidence interval ( CI ) , -15.6 to -5.7 ) .


Mean DBP reductions were -19.0 and -14.1 mmHg in the T80/H25 and T80 groups ( adjusted mean difference , -4.9 mmHg ; 95 % CI , -8.0 to -1.8 ) .


In total , 56.7 % of patients receiving T80/H25 achieved BP goal ( < 140/90 mmHg ) compared with 35.2 % receiving T80 .


SBP goal attainment ( < 140 mmHg ) and DBP goal attainment ( < 90 mmHg ) were also higher in the T80/H25 group compared with the T80 group ( SBP : 69.3 % vs. 48.1 % ; DBP : 62.2 % vs. 46.3 % ) .


A small number of treatment-related adverse events were observed in both T80/H25 ( nine patients , 6.9 % ) and T80 monotherapy ( two patients , 3.6 % ) groups .


In Chinese and Korean patients with moderate-to-severe hypertension , treatment with T80/H25 provided large reductions in mean SBP and DBP , and high BP goal attainment rates .


This once-daily combination is effective and well tolerated in this patient group .


High density lipoproteins ( HDL ) have many cardioprotective roles ; however , in subjects with type 2 diabetes ( T2D ) these cardioprotective properties are diminished .


Conversely , increased fruit and vegetable ( F&V ) intake may reduce cardiovascular disease risk , although direct trial evidence of a mechanism by which this occurs in subjects with T2D is lacking .


Therefore , the aim of this study was to examine if increased F&V consumption influenced the carotenoid content and enzymes associated with the antioxidant properties of HDL in subjects with T2D .


Eighty obese subjects with T2D were randomised to a 1 - or 6-portion/dayF & V diet for 8-weeks .


Fasting serum was collected pre - and post-intervention .


HDL was subfractionated into HDL2 and HDL3 by rapid ultracentrifugation .


Carotenoids were measured in serum , HDL2 and HDL3 by high performance liquid chromatography .


The activity of paraoxonase-1 ( PON-1 ) was measured in serum , HDL2 and HDL3 by a spectrophotometric assay , while the activity of lecithin cholesterol acyltransferase ( LCAT ) was measured in serum , HDL2 and HDL3 by a fluorometric assay .


In the 6 - vs. 1-portion post-intervention comparisons , carotenoids increased in serum , HDL2 and particularly HDL3 , ( - carotene , p = 0.008 ; - cryptoxanthin , p = 0.042 ; lutein , p = 0.012 ; lycopene , p = 0.016 ) , as did the activities of PON-1 and LCAT in HDL3 ( p = 0.006 and 0.044 , respectively ) .


To our knowledge , this is the first study in subjects with T2D to demonstrate that increased F&V intake augmented the carotenoid content and influenced enzymes associated with the antioxidant properties of HDL .


We suggest that these changes would enhance the cardioprotective properties of this lipoprotein .


ISRCTN21676269 .


Premature cardiovascular disease limits the duration and quality of life on long-term hemodialysis .


The objective of this study was to define the frequency of fatal and nonfatal cardiovascular events attributable to atherosclerotic and nonatherosclerotic mechanisms , risk factors for these events , and the effects of cinacalcet , using adjudicated data collected during the EValuation of Cinacalcet HCl Therapy to Lower CardioVascular Events ( EVOLVE ) Trial .


EVOLVE was a randomized , double-blind , placebo-controlled clinical trial that randomized 3883 hemodialysis patients with moderate to severe secondary hyperparathyroidism to cinacalcet or matched placebo for up to 64 months .


For this post hoc analysis , the outcome measure was fatal and nonfatal cardiovascular events reflecting atherosclerotic and nonatherosclerotic cardiovascular diseases .


During the trial , 1518 patients experienced an adjudicated cardiovascular event , including 958 attributable to nonatherosclerotic disease .


Of 1421 deaths during the trial , 768 ( 54 % ) were due to cardiovascular disease .


Sudden death was the most frequent fatal cardiovascular event , accounting for 24.5 % of overall mortality .


Combining fatal and nonfatal cardiovascular events , randomization to cinacalcet reduced the rates of sudden death and heart failure .


Patients randomized to cinacalcet experienced fewer nonatherosclerotic cardiovascular events ( adjusted relative hazard 0.84 , 95 % CI 0.74 to 0.96 ) , while the effect of cinacalcet on atherosclerotic events did not reach statistical significance .


Accepting the limitations of post hoc analysis , any benefits of cinacalcet on cardiovascular disease in the context of hemodialysis may result from attenuation of nonatherosclerotic processes .


Unique identifier : NCT00345839 .


URL : ClinicalTrials.gov .


The aims of this study were to compare radiofrequency tissue reduction ( RFTR ) and electrocautery ( EC ) techniques by assessing preoperatively and 8 weeks postoperatively the visual analog scale ( VAS ) , inspiratory peak flowmetry ( IPF ) , and magnetic resonance imaging ( MRI ) volume measurement of the inferior turbinate and to see whether EC still stands as a valid treatment of inferior turbinate hypertrophy .


A total of 36 patients were included in the study .


An equal number of patients were chosen randomly from 2 groups .


Inferior turbinate volumes measured by MRI , IPF , the VAS , and the Sinonasal Outcome Test-20 were used to determine the efficacy of treatment and to compare the 2 groups .


Postoperative IPF increase , VAS score decrease , and Sinonasal Outcome Test-20 score decrease were statistically more significant in the EC group , compared with the RFTR group .


Although statistically not significant , postoperative inferior turbinate MRI volume decrease was more evident in the EC group when compared with the RFTR group .


Both RFTR and EC techniques could be used as an effective treatment of choice for inferior turbinate hypertrophy , and EC technique is superior to RFTR technique to achieve high efficiency .


Immunization of healthy volunteers during receipt of chemoprophylaxis with Plasmodium falciparum sporozoites ( CPS-immunization ) induces sterile protection from malaria .


Antibody responses have long been known to contribute to naturally acquired immunity against malaria , but their association with sterile protection after whole sporozoite immunization is not well established .


We therefore studied the induction and kinetics of malaria parasite antigen-specific antibodies and memory B-cells ( MBCs ) during CPS-immunization and their correlation with protection from challenge infection .


We assessed humoral reactivity to 9 antigens representing different stages of the life cycle of P. falciparum by performing standardized MBC enzyme-linked immunospot and enzyme-linked immunosorbent assays on peripheral blood mononuclear cells and plasma samples from 38 Dutch volunteers enrolled in 2 randomized controlled clinical trials .


MBCs and antibodies recognizing pre-erythrocytic and cross-stage antigens were gradually acquired during CPS-immunization .


The magnitude of these humoral responses did not correlate with protection but directly reflected parasite exposure in CPS-immunization and challenge .


Humoral responses to the malarial antigens circumsporozoite protein , liver-stage antigen-1 , apical membrane antigen-1 , and merozoite surface protein-1 do not to predict protection from challenge infection but can be used as sensitive marker of recent parasite exposure .


NCT01236612 and NCT01218893 .


To examine effects of music therapy and progressive muscle relaxation training on depression , anxiety and length of hospital stay in Chinese female breast cancer patients after radical mastectomy .


A total of 170 patients were randomly allocated to the intervention group ( n = 85 ) receiving music therapy and progressive muscle relaxation training plus routine nursing care and the control group ( n = 85 ) receiving routine nursing care .


Music therapy and progressive muscle relaxation training were performed twice a day within 48 h after radical mastectomy , once in the early morning ( 6a.m.-8a .


m. ) and once in the evening ( 9p.m.-11p .


m. ) , for 30 min per session until discharged from the hospital .


A general linear model with univariate analysis showed that the intervention group patients had significant improvement in depression and anxiety in the effects of group ( F = 20.31 , P < 0.001 ; F = 5.41 , P = 0.017 ) , time ( F = 56.64 , P < 0.001 ; F = 155.17 , P < 0.001 ) and group * time interaction ( F = 6.91 , P = 0.009 ; F = 5.56 , P = 0.019 ) .


The intervention group patients had shorter length of hospital stay ( 12.56 1.03 ) than that of the control group ( 17.01 2.46 ) with statistical significance ( F = 13.36 , P < 0.001 ) .


Music therapy and progressive muscle relaxation training can reduce depression , anxiety and length of hospital stay in female breast cancer patients after radical mastectomy .


To investigate the effectiveness of Shoushen granule , Chinese herbal preparation , on carotid artery elasticity in patients with carotid atherosclerosis .


The total of 156 carotid atherosclerosis patients were randomly divided into the intervention group ( 83 cases , treated with Shoushen granule ) and the control group ( 73 cases , treated with pravastatin ) .


Brachial-ankle pulse wave velocity baPWV ) and Ankle-Brachial Pressure Index ( ABI ) were measured by automated arteriosclerosis detector .


The changes of common carotid artery intima-media thickness ( IMT ) and parameters of the carotid artery elasticity in patients , including stiffness parameter ( ) , pressure-strain elastic modulus ( Ep ) , arterial compliance ( Ac ) , augmentation index ( AI ) , and pulse wave velocity ( PWV ) were detected by Echo-Tracking ( ET ) technique before and after 24 week treatment .


In the meantime , levels of blood lipid , and liver and renal function were measured respectively .


After 24 weeks , baPWV , MT and parameters of the carotid artery elasticity ( , Ep , AI and PWV ) were markedly decreased in intervention group compared with those of before treatment ( P < 0.01 ) , but the level of Ac was increased significantly ( P < 0.01 ) .


And there were no significant differences compared with control group on the same period ( P > 0.05 ) .


In this pilot study , it was demonstrated ET technology and automated arteriosclerosis detector could be used to evaluate carotid artery elasticity effectively , and the action of Shoushen granule on carotid atherosclerosis might be related to the regulation of carotid artery elasticity .


To determine the effect of nonlinear frequency compression ( NLFC ) on children 's development of speech and language at three years of age .


A randomized controlled trial was conducted as part of the population-based longitudinal study on outcomes of children with hearing impairment ( LOCHI ) .


Participants were randomly assigned to fitting with NLFC ( Phonak Naida V SP or UP ) or with conventional processing in hearing aids , prescribed by using either the NAL or the DSL formula .


Standardized tests of speech production , receptive and expressive language were administered , and parent ratings were collected .


All assessments were double-blinded .


Participants were 44 of the 450 children in the LOCHI cohort .


Compared to children using conventional processing , receptive and expressive language was higher but receptive vocabulary and consonant articulation scores were lower for children who use NLFC .


There was increased substitution of affricates by fricatives for children using NLFC , compared to children using conventional amplification .


After allowing for the effect of multiple demographic variables , the difference in global language scores between groups was not significant ( effect : 0.8 [ 95 % confidence interval : - 6.7 , 8.3 ] ) .


There is insufficient evidence to indicate a difference in language ability between children using NLFC and those using conventional amplification .


A prospective , randomized , controlled , double-blind clinical trial to assess the effect of tramadol and ketamine , 50 mg , added to ropivacaine in brachial plexus anesthesia .


Thirty-six ASA physical statuses I and II patients , between 18 and 60 years of age , scheduled for forearm and hand surgery under axillary brachial plexus block , were allocated to 3 groups .


Group R received 0.375 % ropivacaine in 40 mL , group RT received 0.375 % ropivacaine in 40 mL with 50 mg tramadol , and group RK received 0.375 % ropivacaine in 40 mL with 50 mg ketamine for axillary brachial plexus block .


The onset times and the duration of sensory and motor blocks , duration of analgesia , hemodynamic parameters , and adverse events ( nausea , vomiting , and feeling uncomfortable ) were recorded .


The onset time of sensorial block was the fastest in ropivacaine + tramadol group .


Duration of sensorial and motor block was the shortest in the ropivacaine + tramadol group .


Duration of analgesia was significantly longer in ropivacaine + tramadol group .


We conclude that when added to brachial plexus analgesia at a dose of 50 mg , tramadol extends the onset and duration time of the block and improves the quality of postoperative analgesia without any side effects .


The objective of this study was to assess the effect of golimumab on carotid ultrasound measures and cardiovascular serious adverse events ( SAEs ) in patients with inflammatory arthritides .


An exploratory carotid artery ultrasound substudy was performed in the GO-BEFORE study of methotrexate ( MTX ) - naive rheumatoid arthritis patients , with ultrasounds performed at weeks 0 , 24 , and 52 to measure common carotid artery intima-media thickness , distensibility coefficient , interadventitial diameter , and plaque count .


Cardiovascular SAEs reported over 2 years of follow-up were assessed in 5 golimumab phase 3 clinical trials of patients with rheumatoid arthritis ( GO-BEFORE , GO-FORWARD , and GO-AFTER ) , psoriatic arthritis ( GO-REVEAL ) , and ankylosing spondylitis ( GO-RAISE ) .


In GO-BEFORE and GO-FORWARD , patients received placebo + MTX , golimumab 50 mg + MTX , or golimumab 100 mg + / - MTX at baseline and every 4 weeks ; in the other 3 trials , patients received placebo or golimumab 50 or 100 mg .


The carotid ultrasound substudy showed inconsistent changes in common carotid artery intima-media thickness in the golimumab + MTX groups over time , and there was large variability in the measurements .


Increases in interadventitial diameter were observed in the golimumab 100 mg + placebo group , but not in the golimumab + MTX groups .


There were no significant differences in the distensibility coefficient and plaque count between the golimumab and placebo groups .


Very few patients overall experienced a cardiovascular SAE , and the incidence of cardiovascular SAEs was not statistically different between the golimumab and placebo groups .


The results of the carotid ultrasound substudy were inconclusive , and no increase or decrease in cardiovascular SAEs was observed following 2 years of treatment with golimumab with or without MTX .


Although botulinum toxin type A ( BoNT-A ) has been used effectively and safely to reduce facial dynamic wrinkles , few studies assessed patients ' quality of life and satisfaction after treatment .


To assess the quality of life and satisfaction of patients treated with full-face injections of variable doses of abobotulinum toxin A ( ABO ) .


Ninety subjects were randomized into 3 different groups , receiving 120-165 U , 166-205 U and 206-250 U , respectively .


WHOQOL - BREF and Satisfaction and Self-assessment Questionnaire ( SSQ ) were completed by subjects up to 6 months after treatment .


Most of the subjects were women ( 96.5 % ) .


For the physical domain in WHOQOL , a difference was observed between baseline and visit 2 ( p = 0.036 ) .


There was no difference between groups for mean grades regarding amount of wrinkles , beauty , harmony and symmetry .


However , there was a significant difference in the mean grades between visits .


Patients ' opinions also showed an improvement in their self-image up to four months after treatment , according to the self-grading .


The results presented in this study show improvements in patients ' quality of life during the peak of action of BoNT-A treatment , regarding the physical aspect .


In addition , patients reported good satisfaction after a full-face approach .


This study extends previous research on masculinity and negative drinking consequences among young men by considering mediating effects of heavy episodic drinking ( HED ) and alcohol expectancies .


We hypothesized that masculinity would have a direct relationship with negative consequences from drinking as well as indirect relationships mediated by HED and alcohol expectancies of courage , risk , and aggression .


A random sample of 1,436 college and university men ages 19-25 years completed an online survey , including conformity to masculine norms , alcohol-related expectancies , HED , and negative drinking consequences .


Regression analyses and structural equation modeling were used .


Six of seven dimensions of masculinity and the alcohol expectancy scales were significantly associated with both HED and negative consequences .


In multivariate regression models predicting HED and negative consequences , the playboy and violence dimensions of masculinity and the risk/aggression alcohol expectancy remained significant .


HED and the risk-taking dimension of masculinity were also significant in the model predicting negative consequences .


The structural equation model indicated that masculinity was directly associated with HED and negative consequences but also influenced negative consequences indirectly through HED and alcohol expectancies .


The findings suggest that , among young adult male college and university students , masculinity is an important factor related to both HED and drinking consequences , with the latter effect partly mediated by HED and alcohol expectancies .


Addressing male norms about masculinity may help to reduce HED and negative consequences from drinking .


To evaluate the acceptance of midazolam spray through buccal route as compared to intranasal route and compare the efficacy of the drug through both the routes .


30 patients aged 2-8 years with Grade I or II Frankl 's Behaviour Rating Scale were selected who required similar treatment under local anesthesia on two teeth .


Midazolam spray was administered randomly through buccal or intranasal routes for the two appointments .


Scoring was done for the acceptance of drug and Houpt 's score was recorded for the behaviour of patients during the treatment .


Acceptance of drug through buccal route was significantly better than the intranasal route ( p < 0.05 ) but no statistically significant difference was found in the behaviour scores for the two routes of administration ( p > 0.05 ) .


Midazolam spray can be effectively used through the buccal mucosa in children who give poor compliance with the intranasal administration .


To compare the efficacy and adverse effects of ergometrine and oxytocin given intramuscularly for the prevention of postpartum hemorrhage during the third stage of labor .


The study included women with a singleton pregnancy of at least 28 weeks ' gestation who had a vaginal delivery .


High-risk pregnancies were excluded .


Oxytocin ( 10 IU ) or ergometrine ( 0.5 mg ) were administered intramuscularly in a blinded pattern immediately after delivery of the infant .


An intention-to-treat analysis was performed .


Postpartum blood loss ( 301.8 109.2 mL versus 287.1 84.4 mL , P = 0.011 ) and packed cell volume ( 30.7 1.7 % versus 31.6 2.0 % ; Z = 0.00 ; P = 0.008 ) were considerably reduced among parturients who received intramuscular ergometrine .


The rates of therapeutic oxytocics use , blood transfusion , placental retention , and manual removal of the placenta were significantly higher in the oxytocin group .


No significant differences between the groups were observed in terms of adverse effects , with the exception of diastolic hypertension , which was more common in the ergometrine group ( odds ratio , 0.00 ; 95 % confidence interval , 0.00-0 .75 ; P = 0.007 ) .


Intramuscular ergometrine is superior to intramuscular oxytocin in averting postpartum hemorrhage during the third stage of labor .


There are no significant risks of adverse effects except for diastolic hypertension .


We aim to report the `` deep tiny flow voids '' ( DTFV ) , a unique HR-MRI finding suggestive of deep collateral vessels along middle cerebral artery ( MCA ) occlusions .


We retrospectively reviewed the HR-MRI data of 60 patients with unilateral MCA occlusion ( 32 symptomatic and 28 asymptomatic ) and 205 control subjects with normal MCA on magnetic resonance angiography .


The presence or absence of DTFV , defined as three or more flow voids along the occluded MCA on at least two consecutive T2-weighted image slices , was observed .


The relationships among DTFV , clinical presentations , and infarct sizes were analyzed .


DTFV were identified in 20/28 ( 71 % ) patients with asymptomatic MCA occlusions , much more frequently than in the patients with symptomatic occlusions ( 5/32 , 16 % ) ( P < 0.001 ) .


There were 9 patients with a large territorial infarction ( 1/3 MCA distribution ) , none of whom had DTFV on HR-MRI .


DTFV was not observed in any control subject .


DTFV are pathological conditions and associated with relatively good imaging outcomes and asymptomatic MCA occlusions .


The function and clinical implications of DTFV warrant further investigations .


Little is known about the optimal duration of antibiotic therapy for diabetic foot osteomyelitis ( DFO ) .


This study sought to compare the effectiveness of 6 versus 12 weeks of antibiotic therapy in patients with DFO treated nonsurgically ( i.e. , antibiotics alone ) .


This was a prospective randomized trial comparing 6 - versus 12-week duration of antibiotic treatment .


Remission of osteomyelitis during the monitoring period was defined as complete and persistent ( > 4 weeks ) healing of the wound ( if present initially ) , absence of recurrent infection at the initial site or that of adjacent rays , and no need for surgical bone resection or amputation at the end of a follow-up period of at least 12 months after completion of antibiotic treatment .


Forty patients followed at five French general hospitals were randomized between January 2007 and January 2009 , with 20 treated for 6 weeks and 20 treated for 12 weeks with antibiotics .


The two groups were comparable for all variables recorded at inclusion in the study .


Remission was obtained in 26 ( 65 % ) patients , with no significant differences between patients treated for 6 versus 12 weeks ( 12/20 vs. 14/20 , respectively ; P = 0.50 ) .


We did not identify any significant parameters associated with patient outcome .


Fewer patients treated for 6 weeks experienced gastrointestinal adverse events related to antimicrobial therapy compared with patients treated for 12 weeks ( respectively , 15 vs. 45 % ; P = 0.04 ) .


The present multicenter prospective randomized study provides data suggesting that 6-week duration of antibiotic therapy may be sufficient in patients with DFO for whom nonsurgical treatment is considered .


OnabotulinumtoxinA was effective and well tolerated for prophylaxis of headache in patients with chronic migraine ( CM ) in two randomized , double-blind , placebo-controlled , phase 3 trials .


To further assess the safety and tolerability of onabotulinumtoxinA in CM prophylaxis in adults , the pooled safety data from four double-blind , placebo-controlled trials were analyzed .


The pooled analysis included two phase 2 and two phase 3 double-blind , placebo-controlled trials .


The safety population was 2436 patients , 1997 of whom received 1 dose of onabotulinumtoxinA .


The studies shared similar dosing intervals ( approximately 12weeks ) with doses between 75 and 260U .


Safety assessments included adverse events ( AEs ) , physical examination and clinical laboratory tests .


OnabotulinumtoxinA was safe and well tolerated , with a low discontinuation rate ( 3.4 % ) due to AEs .


The majority of patients in this pooled analysis received doses between 150 and 200U , with an average of 163U per treatment cycle .


Of the 1997 patients who received any onabotulinumtoxinA injections , 1455 patients ( 72.9 % ) reported at least one AE .


Neck pain ( 12.6 % ) was the most common onabotulinumtoxinA-associated AE , followed by muscle weakness ( 8.0 % ) , musculoskeletal stiffness ( 6.1 % ) and eyelid ptosis ( 4.6 % ) .


Serious AEs were infrequent , occurring in 5.4 % of patients who received any onabotulinumtoxinA treatment and 3.0 % of patients receiving placebo .


AEs were consistent with the known tolerability profile of onabotulinumtoxinA .


Multiple treatments with onabotulinumtoxinA at doses of 75-260U administered every 12weeks , and up to five treatment cycles , were well tolerated for the prophylaxis of headache in adults with CM .


To assess the effects of intravitreal ranibizumab on diabetic retinopathy ( DR ) severity when administered for up to 3 years , evaluate the effect of delayed initiation of ranibizumab therapy on DR severity , and identify baseline patient characteristics associated with the development of proliferative DR ( PDR ) .


Exploratory analyses of phase III , randomized , double-masked , sham-controlled multicenter clinical trials .


Adults with diabetic macular edema ( DME ) ( N = 759 ) , baseline best-corrected visual acuity 20/40 to 20/320 Snellen equivalent , and central foveal thickness 275 m.


Patients were randomized to monthly 0.3 or 0.5 mg ranibizumab or sham injections .


Sham participants could switch to 0.5 mg ranibizumab during the third year ( sham/0 .5 mg crossover ) .


Baseline risk factors were evaluated to explore potential associations with development of PDR .


Time to first development of PDR was analyzed by Kaplan-Meier methods to calculate cumulative probabilities by group .


Study eye change on the Early Treatment Diabetic Retinopathy Study severity scale and a composite clinical outcome evaluating progression to PDR based on photographic changes plus clinically important events defining PDR .


At month 36 , a greater proportion of ranibizumab-treated eyes had 2 - or 3-step DR improvement compared with sham/0 .5 mg crossover .


A 3-step improvement was achieved at 36 months by 3.3 % , 15.0 % , and 13.2 % of sham/0 .5 mg , 0.3 mg , and 0.5 mg ranibizumab-treated eyes , respectively ( P < 0.0001 ) .


Through 36 months , 39.1 % of eyes in the sham/0 .5 mg group developed PDR , as measured by composite outcome , compared with 18.3 % and 17.1 % of eyes treated with 0.3 or 0.5 mg ranibizumab , respectively .


The presence of macular capillary nonperfusion at baseline seems to be associated with progression to PDR in ranibizumab-treated eyes but did not meaningfully influence visual acuity improvement in eyes with DME after ranibizumab therapy .


Ranibizumab , as administered to patients with DME for 12 to 36 months in these studies , can both improve DR severity and prevent worsening .


Prolonged delays in initiation of ranibizumab therapy may limit this therapeutic effect .


Although uncommon , the development of PDR still occurs in a small percentage of eyes undergoing anti-vascular endothelial growth factor therapy and may be related to the presence of macular nonperfusion .


This study sought to prospectively evaluate changes in marginal bone levels and soft tissue dimensions around platform-switched , Morse taper-connection implants placed with the implant-abutment interface ( IAI ) at different positions in relation to the alveolar crest .


Thirty patients in need of single-tooth rehabilitations were randomly assigned to three groups based on the position of the IAI in relation to the alveolar crest at the time of implant placement .


Implants in groups 0 , 1 , and 2 ( n = 10 in each group ) were placed at the bone level or 1 mm and 2 mm below the buccal aspect of the alveolar crest , respectively .


Four months later , the implants were restored with crowns .


Clinical parameters were recorded at 4 and 12 months , and marginal bone levels were assessed radiographically at placement , 4 months , and 12 months .


Mean marginal bone loss below the implant platform in group 0 implants was 0.18 0.27 mm at 4 months and 0.27 0.45 mm at 12 months .


All implants in groups 1 and 2 exhibited no marginal bone loss below the implant platform , since the first bone-to-implant contact was located at or above the implant margin .


At 12 months , implants in groups 1 and 2 exhibited greater mean bone loss above the implant platform compared to implants in group 0 , but the differences were not statistically significant ( group 0 , 0.64 0.49 mm ; group 1 , 0.81 0.31 mm ; group 2 , 1.20 0.68 mm ) .


Implants in groups 1 and 2 exhibited a statistically significantly higher percentage of implant surfaces with bone on the implant platform compared to group 0 implants ( 90 % versus 35 % ) .


In the present study , differences in peri-implant bone responses existed for implants placed with the IAI at different locations in relation to the alveolar crest .


In Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy ( MADIT-CRT ) , patients with non-left bundle branch block ( LBBB ; including right bundle branch block , intraventricular conduction delay ) did not have clinical benefit from cardiac resynchronization therapy with defibrillator ( CRT-D ) .


We hypothesized that baseline PR interval modulates clinical response to CRT-D therapy in patients with non-LBBB .


Non-LBBB patients ( n = 537 ; 30 % ) were divided into 2 groups based on their baseline PR interval as normal ( including minimally prolonged ) PR ( PR < 230 ms ) and prolonged PR ( PR 230 ms ) .


The primary end point was heart failure or death .


Separate secondary end points included heart failure events and all-cause mortality .


Cox proportional hazards regression models were used to compare risk of end point events by CRT-D to implantable cardioverter defibrillator therapy in the PR subgroups .


There were 96 patients ( 22 % ) with a prolonged PR and 438 patients ( 78 % ) with a normal PR interval .


In non-LBBB patients with a prolonged PR interval , CRT-D treatment was associated with a 73 % reduction in the risk of heart failure/death ( hazard ratio , 0.27 ; 95 % confidence interval , 0.13-0 .57 ; P < 0.001 ) and 81 % decrease in the risk of all-cause mortality ( hazard ratio , 0.19 ; 95 % confidence interval , 0.13-0 .57 ; P < 0.001 ) compared with implantable cardioverter defibrillator therapy .


In non-LBBB patients with normal PR , CRT-D therapy was associated with a trend toward an increased risk of heart failure/death ( hazard ratio , 1.45 ; 95 % confidence interval , 0.96-2 .19 ; P = 0.078 ; interaction P < 0.001 ) and a more than 2-fold higher mortality ( hazard ratio , 2.14 ; 95 % confidence interval , 1.12-4 .09 ; P = 0.022 ; interaction P < 0.001 ) compared with implantable cardioverter defibrillator therapy .


The data support the use of CRT-D in MADIT-CRT non-LBBB patients with a prolonged PR interval .


In non-LBBB patients with a normal PR interval , implantation of a CRT-D may be deleterious .


http://clinicaltrials.gov; Unique Identifier : NCT00180271 .


Diabetic patients treated with metformin have a lower risk of developing BC or a better BC prognosis .


Metformin might reduce cancer growth through direct antiproliferative effects or through indirect mechanisms , particularly the reduction of insulin .


In a randomized study on nondiabetic BC patients in natural menopause with hightestosterone levels , we observed a significant decrease in insulin and in testosterone levels with metformin 1500mg/d compared with 1000 mg/d .


We present the results of a new analysis of our study on the effect of metformin on the bioavailability of sex hormones .


One hundred twenty-four eligible women were initiallyinvited to take metformin 500 mg/d for 3 months .


The 108 women who completed the first 3 months continued the study using 1000 mg/d for 1 month .


The women were then randomized into 2 groups , and , for the subsequent 5months , 1 group increased the dose to 1500 mg/d , and the other group continued with 1000 mg/d .


Ninety-six women completed the study , 43 receiving metformin 1500 mg/day , and 53 receiving 1000 mg/day .


The women receiving 1500 mg/d showed a greater and significant reduction of free testosterone ( -29 % ) and estradiol ( -38 % ) , a borderline significant reduction of estrone and insulin-like growth factor-1 , and a nonsignificant reduction of androstenedione .


They also showed a nonsignificant increase of dehydroepiandrosterone sulfate .


Metformin does not interfere with the production of dehydroepiandrosterone sulfate .


Besides , it decreases estradiol levels , basically through the reduction of testosterone .


These hormonal changes might have clinical relevance .


Upper airway obstruction ( UAO ) is a major problem in unconscious subjects , making full face mask ventilation difficult .


The mechanism of UAO in unconscious subjects shares many similarities with that of obstructive sleep apnea ( OSA ) , especially the hypotonic upper airway seen during rapid eye movement sleep .


Continuous positive airway pressure ( CPAP ) via nasal mask is more effective at maintaining airway patency than a full face mask in patients with OSA .


We hypothesized that CPAP via nasal mask and ventilation ( nCPAP ) would be more effective than full face mask CPAP and ventilation ( FmCPAP ) for unconscious subjects , and we tested our hypothesis during induction of general anesthesia for elective surgery .


In total , 73 adult subjects requiring general anesthesia were randomly assigned to one of four groups : nCPAP P0 , nCPAP P5 , FmCPAP P0 , and FmCPAP P5 , where P0 and P5 represent positive end-expiratory pressure ( PEEP ) 0 and 5 cm H2O applied prior to induction .


After apnea , ventilation was initiated with pressure control ventilation at a peak inspiratory pressure over PEEP ( PIP/PEEP ) of 20/0 , then 20/5 , and finally 20/10 cm H2O , each applied for 1 min .


At each pressure setting , expired tidal volume ( Vte ) was calculated by using a plethysmograph device .


The rate of effective tidal volume ( Vte > estimated anatomical dead space ) was higher ( 87.9 % vs. 21.9 % ; P < 0.01 ) and the median Vte was larger ( 6.9 vs. 0 mL/kg ; P < 0.01 ) with nCPAP than with FmCPAP .


Application of CPAP prior to induction of general anesthesia did not affect Vte in either approach ( nCPAP pre - vs. post - ; 7.9 vs. 5.8 mL/kg , P = 0.07 ) ( FmCPAP pre - vs. post - ; 0 vs. 0 mL/kg , P = 0.11 ) .


nCPAP produced more effective tidal volume than FmCPAP in unconscious subjects .


ClinicalTrials.gov identifier : NCT01524614 .


Viral upper respiratory tract infections occur frequently among conscripts .


Probiotics have reduced viral infections in children attending day care .


Limited data are available on the effects of probiotics on the nasopharyngeal presence of respiratory viruses .


To assess , whether probiotics could decrease nasopharyngeal occurrence of respiratory viruses in Finnish conscripts .


In a randomized , double-blind , placebo-controlled 90 - and 150-day intervention study , 239 nasopharyngeal swab samples were collected from 192 symptomatic conscripts receiving daily chewable probiotic tablet containing Lactobacillus rhamnosus GG and Bifidobacterium animalis ssp .


lactis BB-12 ( 46.9 % ) or control tablet ( 53.1 % ) on visits to a garrison 's health care center due to symptoms of infection .


The presence of respiratory viruses was tested by PCR-methods , and viral findings were compared between the intervention groups .


184 ( 76.9 % ) nasopharyngeal samples were positive for at least one respiratory virus .


Picornaviruses were the most common viruses and were detected in 155 ( 84.2 % ) of samples .


Of these , 143 ( 92.3 % ) were rhinovirus-positive and 20 ( 12.9 % ) were enterovirus-positive .


The control group had 83 ( 64 % ) and the probiotic group 72 ( 66 % ) picornavirus infections ( p = 0.79 ) .


Monthly distribution of picornaviruses showed that there were less picornavirus findings after 3 months in the probiotic group than in the control group ( p = 0.0069 ) .


However , probiotics did not reduce picornavirus occurrence in other months .


Overall , probiotics did not reduce viral occurrence in symptomatic conscripts .


However , probiotics decreased the presence of picornaviruses after 3 months , which may imply that probiotics play a role against viruses causing common cold .


Further investigations are necessary to clarify the mechanisms involved in order to target specific probiotics on specific respiratory viruses .


Many hypertensive subjects travel to high altitudes , but little is known on ambulatory blood pressure ( ABP ) changes and antihypertensive drugs ' efficacy under acute and prolonged exposure to hypobaric hypoxia .


In particular , the efficacy of angiotensin receptor blockers in this condition is unknown .


This may be clinically relevant considering that renin-angiotensin system activity changes at altitude .


The HIGHCARE-HIMALAYA study assessed changes in 24 h ABP under acute and prolonged exposure to increasing altitude and blood pressure-lowering efficacy and safety of an angiotensin receptor blockade in this setting .


Forty-seven healthy , normotensive lowlanders were randomized to telmisartan 80 mg or placebo in a double-blind , parallel group trial .


Conventional and Ambulatory BPs were measured at baseline and on treatment : after 8 weeks at sea level , and under acute exposure to 3400 and 5400 m altitude , the latter upon arrival and after 12 days ( Mt. Everest base camp ) .


Blood samples were collected for plasma catecholamines , renin , angiotensin , and aldosterone .


In both groups , exposure to increasing altitude was associated with : ( i ) significant progressive increases in conventional and 24 h blood pressure , persisting throughout the exposure to 5400 m ; ( ii ) increased plasma noradrenaline and suppressed renin-angiotensin-aldosterone system .


Telmisartan lowered 24 h ABP at the sea level and at 3400 m ( between-group difference 4.0 mmHg , 95 % CI : 2.2-9 .5 mmHg ) , but not at 5400 m.


Ambulatory blood pressure increases progressively with increasing altitude , remaining elevated after 3 weeks .


An angiotensin receptor blockade maintains blood pressure-lowering efficacy at 3400 m but not at 5400 m.


To determine the impact of recombinant luteinizing hormone ( rLH ) combined with vaginal progesterone ( P ) for luteal supplementation on in vitro fertilization ( IVF ) pregnancy outcomes in high-responder patients undergoing long gonadotropin-releasing hormone ( GnRH ) agonist cycles .


A total of 47 patients undergoing IVF cycles with the serum estradiol levels of > or = 2,500 pg/mL on the day of human chorionic gonadotropin administration were included in this prospective randomized study .


Patients were divided into 2 treatment groups : the control group ( n = 23 ) used luteal vaginal P , and the study group ( n = 24 ) received a combination of vaginal P and 75 IU rLH , 4 doses every 3 days , starting on the day of embryo transfer .


The main outcome measure was the clinical pregnancy rate ( PR ) .


The study group had 11 pregnancies ( 45.8 % ) , while the control group had 6 ( 26.1 % ) .


There was no significant difference between the groups in clinical PRs ( p = 0.15 ) .


No differences were found with respect to the implantation rate , miscarriage rate , and multiple PR .


Our data show that luteal supplementation with rLH combined to vaginal P was not found to improve pregnancy outcomes in high responder patients undergoing long GnRH agonist IVF treatments .


Based on the result of our previous study showing better overall survival ( OS ) at the lower dose ( 0.2 g ) of immunomodulator Z-100 than higher dose ( 40 g ) in patients with locally advanced cervical cancer who received radiotherapy , we conducted a placebo-controlled double-blind randomized trial .


Patients of stages IIB-IVA squamous cell carcinoma of the uterine cervix were randomly assigned to receive Z-100 at 0.2 g ( Z ) or placebo ( P ) .


The study agent was given subcutaneously twice a week during the radiotherapy , followed by maintenance therapy by administering once every 2 weeks until disease progression .


Primary end point was OS , and secondary end points were recurrence-free survival , and toxicity .


A total of 249 patients were randomized .


Death events occurred extremely slower than expected , and Independent Data Monitoring Committee recommended to analyze the survival result prematurely .


The 5-year OS rate was 75.7 % [ 95 % confidence interval ( CI ) 66.4 % to 82.8 % ] for Arm Z and 65.8 % ( 95 % CI 56.2 % to 73.8 % ) for Arm P ( P = 0.07 ) ; hazard ratio was 0.65 ( 95 % CI 0.40-1 .04 ) .


Survival benefit in Arm Z was observed regardless of chemoradiation or radiation alone .


There was no trend in recurrence-free survival between the two arms .


Side-effects were not different between two arms .


Z-100 showed a trend of improvement on OS in locally advanced cervical cancer , although the statistical power was less than anticipated because survival rates were unexpectedly higher than expected for both arms .


Validation of potential survival benefit of immune modulation should be made .


umin.ac.jp / ctr Identifier : C000000221 .


To compare the efficacy and safety of two different second-generation ablation devices , Novasure impedance control system and microwave endometrial ablation ( MEA ) , in cases of abnormal uterine bleeding ( AUB ) .


This is a randomized controlled trial that took place in a single Gynecological Department of a University Hospital .


Sixty-six women with dysfunctional uterine bleeding ( DUB ) , unresponsive to medical treatment , were included in the trial .


The ratio of women allocated to bipolar radio-frequency ablation or MEA was 1:1 .


Follow-up assessments were carried out at three and 12 months post-ablation .


The present main outcome measure was amenorrhea rates 12-months post-treatment .


The rate of amenorrhea at 12-months post-ablation was significantly higher in women treated by Novasure ( 25/33 ; 75.8 % ) as compared to those treated by MEA ( 8/33 ; 24.2 % ) ( rate difference : +51.5 % , 95 % CI : +27.8 to +67.7 ) .


In women with DUB , endometrial ablation with Novasure bipolar radiofrequency impedance-controlled system is associated with increased rates of amenorrhea at 12-months post-treatment as compared to the MEA method .


To determine the effects of different intra-abdominal pressure values on visceral pain following gynecologic laparoscopic surgery in the Trendelenburg position .


This randomized , controlled prospective trial was conducted at a tertiary education hospital and included 150 patients who underwent gynecologic laparoscopy with different abdominal insufflation pressures .


There were 54 patients in the 8 mmHg low pressure group ( LPG ) , 45 in the 12 mmHg standard pressure group ( SPG ) , and 51 in the 15 mmHg high pressure group ( HPG ) .


We assessed mean age , body mass index ( BMI ) , duration of surgery , analgesic consumption , length of hospital stay , amount of CO2 expended and volume of hemorrhage .


Visceral pain and referred visceral pain were assessed 6 , 12 , and 24 h postoperatively using a visual analog scale ( VAS ) .


There was no significant difference in age , BMI , analgesic consumption or length of hospital stay among groups .


The mean operative time and total CO2 expended during surgery were higher in the LPG compared with the SPG and HPG .


The mean intensity of postoperative pain assessed by the VAS score at 6 and 12 h was less in the LPG than in the SPG and HPG and was reduced significantly at 12 h. VAS scores at 24 h in the LPG and SPG were lower than in the HPG .


Pain is reduced by low insufflation pressure compared with standard and high insufflation pressure following gynecologic laparoscopic surgery in the Trendelenburg position .


However , low insufflation pressure may result in longer operation times and increased hemorrhage .


The role of lipid-lowering treatments in renoprotection for patients with diabetes is debated .


We studied the renal effects of two statins in patients with diabetes who had proteinuria .


PLANET I was a randomised , double-blind , parallel-group trial done in 147 research centres in Argentina , Brazil , Bulgaria , Canada , Denmark , France , Hungary , Italy , Mexico , Romania , and the USA .


We enrolled patients with type 1 or type 2 diabetes aged 18 years or older with proteinuria ( urine protein : creatinine ratio [ UPCR ] 500-5000 mg/g ) and taking stable angiotensin-converting enzyme inhibitors , angiotensin receptor blockers , or both .


We randomly assigned participants to atorvastatin 80 mg , rosuvastatin 10 mg , or rosuvastatin 40 mg for 52 weeks .


The primary endpoint was change from baseline to week 52 of mean UPCR in each treatment group .


The study is registered with ClinicalTrials.gov , number NCT00296374 .


We enrolled 353 patients : 118 were assigned to rosuvastatin 10 mg , 124 to rosuvastatin 40 mg , and 111 to atorvastatin 80 mg ; of these , 325 were included in the intention-to-treat population .


UPCR baseline : week 52 ratio was 087 ( 95 % CI 077-099 ; p = 0033 ) with atorvastatin 80 mg , 102 ( 088-118 ; p = 083 ) with rosuvastatin 10 mg , and 096 ( 083-111 ; p = 053 ) with rosuvastatin 40 mg .


In a post-hoc analysis to compare statins , we combined data from PLANET I with those from PLANET II ( a similar randomised parallel study of 237 patients with proteinuria but without diabetes ; registered with ClinicalTrials.gov , NCT00296400 ) .


In this analysis , atorvastatin 80 mg lowered UPCR significantly more than did rosuvastatin 10 mg ( -156 % , 95 % CI -283 to -05 ; p = 0043 ) and rosuvastatin 40 mg ( -182 % , -302 to -42 ; p = 0013 ) .


Adverse events occurred in 69 ( 60 % ) of 116 patients in the rosuvastatin 10 mg group versus 79 ( 64 % ) of 123 patients in the rosuvastatin 40 mg group versus 63 ( 57 % ) of 110 patients in the atorvastatin 80 mg group ; renal events occurred in nine ( 78 % ) versus 12 ( 98 % ) versus five ( 45 % ) .


Despite high-dose rosuvastatin lowering plasma lipid concentrations to a greater extent than did high-dose atorvastatin , atorvastatin seems to have more renoprotective effects for the studied chronic kidney disease population .


AstraZeneca .


To investigate the efficacy and safety of combining vandetanib , an orally available multi-targeted tyrosine kinase inhibitor of vascular endothelial growth factor receptor-2 ( VEGFR-2 ) and epidermal growth factor receptor ( EGFR ) , with bicalutamide in patients with metastatic castration-resistant prostate cancer ( mCRPC ) .


This was an open-label , randomized phase II multi-center study .


Eligible patients had rising PSA on androgen deprivation therapy , minimal symptoms and were chemotherapy-nave .


Protocol therapy was either vandetanib 300 mg oral daily plus bicalutamide 50 mg oral daily ( Arm A ) or bicalutamide 50 mg oral daily alone ( Arm B ) with cross-over to vandetanib monotherapy at progression .


The primary endpoint was PSA response ( 50 % decline from baseline ) .


Thirty-nine patients were recruited , 19 in Arm A and 20 in Arm B. PSA response was comparable in Arm A and Arm B ( 18 vs. 19 % ) .


Time to PSA progression was 3.16 months ( 95 % confidence interval ( CI ) : 1.09 , not reached ( NR ) ) for Arm A and 3.09 months ( 95 % CI : 1.22 , NR ) for Arm B. Treatment discontinuation due to adverse events was more common in Arm A compared to Arm B ( 42 vs. 5 % ; p = 0.019 ) .


Treatment with vandetanib was associated with a reduction in soluble VEGFR-2 levels after two cycles but an increase in plasma VEGF levels .


The combination of vandetanib and bicalutamide was associated with considerable toxicity and did not have superior efficacy over bicalutamide alone .


Further evaluation of this combination is not warranted in mCRPC .


FcR polymorphisms have been reported to enhance the immune-mediated effects of cetuximab in metastatic colorectal cancer .


There are no data on the relationship between these polymorphisms and cetuximab in the early-stage setting .


We performed a pharmacogenomic analysis of EXPERT-C , a randomized phase II trial of neoadjuvant CAPOX followed by chemoradiotherapy , surgery , and adjuvant CAPOXcetuximab in high-risk , locally advanced rectal cancer .


FcRIIa-H131R and FcRIIIa-V158F polymorphisms were analyzed on DNA from peripheral blood samples .


Kaplan-Meier method and Cox regression analysis were used to calculate survival estimates and compare treatment arms .


Genotyping was successfully performed in 105 of 164 ( 64 % ) patients ( CAPOX = 54 , CAPOX-C = 51 ) .


No deviation from the Hardy-Weinberg equilibrium or association of these polymorphisms with tumor RAS status was observed .


FcRIIa-131R ( HR , 0.38 ; P = 0.058 ) and FcRIIIa-158F alleles ( HR , 0.21 ; P = 0.007 ) predicted improved progression-free survival ( PFS ) in patients treated with cetuximab .


In the CAPOX-C arm , carriers of both 131R and 158F alleles had a statistically significant improvement in PFS ( 5 years : 78.4 % ; HR , 0.22 ; P = 0.002 ) and overall survival ( OS ; 5 years : 86.4 % ; HR , 0.24 ; P = 0.018 ) when compared with patients homozygous for 131H and/or 158V ( 5-year PFS : 35.7 % ; 5-year OS : 57.1 % ) .


An interaction between cetuximab benefit and 131R and 158F alleles was found for PFS ( P = 0.017 ) and remained significant after adjusting for prognostic variables ( P = 0.003 ) .


This is the first study investigating FcRIIa and FcRIIIa polymorphisms in patients with early-stage colorectal cancer treated with cetuximab .


We showed an increased clinical benefit from cetuximab in the presence of 131R and 158F alleles .


Diabetic cardiomyopathy defined as either systolic or diastolic dysfunction in otherwise healthy diabetic persons is not clearly understood .


The prevalence and outcomes of this disease in a community-based population have not been defined .


Cross-sectional survey of 2042 randomly selected residents of Olmsted County , Minnesota , aged 45 years or older between June 1997 and September 2000 .


All patients underwent Doppler echocardiographic assessment of systolic and diastolic function .


Diabetic cardiomyopathy was defined in a person with diabetes and any systolic or at least moderate diastolic dysfunction without a history of coronary disease , hypertension , significant valvular disease , or congenital heart disease .


The diagnosis of diabetic cardiomyopathy was made in 23 people , corresponding to a community population prevalence rate of 1.1 % .


Among diabetic patients , 16.9 % met criteria for diabetic cardiomyopathy and 54.4 % had diastolic dysfunction .


Diabetes was associated with a 1.9-fold increase in risk of any left ventricular dysfunction , a 1.7-fold increase in risk of diastolic dysfunction , and a 2.2-fold increase in risk of systolic dysfunction .


Among patients with diabetic cardiomyopathy , the cumulative probability of death was 18 % , development of heart failure was 22 % , and development of death or heart failure was 31 % at 9 years .


Diabetic cardiomyopathy is relatively common in the community with a prevalence of 1.1 % .


The morbidity and mortality of patients with diabetic cardiomyopathy is high .


Protein source , macronutrient composition and content of long chain-polyunsaturated fatty acids ( LC-PUFA ) of infant formulae may influence infant growth .


We aimed to assess the effect of a modified infant formula on growth .


In a randomized , double-blind trial , 213 healthy term infants consumed isoenergetic study formulae ( intervention formula - IF , control formula - CF ) from the first month of life until the age of 120 days .


IF ( 1.89 g protein/100 kcal ) contained - lactalbumin ( ALAB ) and LC-PUFA , while CF ( 2.30 g protein/100 kcal ) provided standard whey and no LC-PUFA .


Anthropometry and dietary intake were regularly assessed .


A venous blood sample was obtained on day 120 .


Both formulae were well-accepted without significant differences in health related observations .


Weight gain was not statistically different between formula groups ( IF : 30.2 6.3 vs. CF : 28.3 6.5 g/day , mean SD , P = 0.06 ) .


Length gain was higher in IF ( 0.11 0.02 vs. 0.10 0.02 cm/day , P = 0.02 ) .


Energy intake from formula was higher in CF at 90 and 120 days ( IF : 509 117 and 528 123 vs. CF : 569 152 and 617 169 kcal/day , P < 0.01 ) .


Protein intake in CF was significantly higher at each assessment .


Growth per energy intake was higher in IF compared to CF for weight ( 6.45 2.01 vs. 5.67 2.21 g/100 kcal , P = 0.02 ) and length ( 0.23 0.08 vs. 0.20 0.08 mm/100 kcal , P = 0.04 ) .


The modified infant formula with reduced protein content with added ALAB and LC-PUFA , meets infant requirements of protein for adequate growth .


The increased energetic efficiency of the new infant formula might result from improved protein composition by added ALAB .


Apparently minor differences in composition can markedly affect energetic efficiency for growth .


The study was registered at ClinicalTrials.gov ( NCT01094080 ) .


This study examines the effects of parental lisdexamfetamine ( LDX ) treatment on parent-child interactions .


Participants were 30 parents ( 27 % were male ) and their children aged 5-12 years , both diagnosed with DSM-IV attention-deficit/hyperactivity disorder ( ADHD ) .


Optimal LDX dose ( 30 , 50 , or 70 mg/day ) was determined for parents during a 3-week open-label titration , followed by a within-subjects trial of the acute impact of LDX and placebo on observable parent-child interactions .


Two laboratory-based , parent-child interactions simulating typical family tasks ( e.g. , homework , joint play ) were conducted within 2 weeks , once with the adult on a blinded optimal dose of LDX and once on placebo ( phase I ) .


Parents were then randomly assigned to continue blinded treatment with LDX or placebo for another month followed by a third interaction task ( phase II ) to assess the ongoing effects of LDX on parent-child interactions .


The primary outcome was the change in rate of parenting behaviors coded during the parent-child interaction tasks .


Secondary outcomes included observed rates of children 's inappropriate behaviors during the laboratory tasks and changes in parental ADHD symptom severity ( ADHD-Rating Scale ) .


Twenty parents ( 67 % ) completed the trial .


In phase I , medication was associated with a significant reduction in negative talk by parents ( p = 0.0066 , d = -0.47 ) .


There was a Medication Task interaction ( p = 0.0235 ) with a reduction in children 's negative behaviors in the homework phase only ( p = 0.0154 , d = -0.58 ) .


In phase II , LDX was associated with significant increases in praise by parents ( d = 0.81 ) and reductions in parental commands ( d = -0.88 ) and children 's inappropriate behaviors ( d = -0.84 ) ( all p-values < 0.05 ) .


While not reaching statistical significance , LDX was also associated with large reductions in parental verbalizations ( d = -0.82 ) , moderate increases in parental responsiveness ( d = 0.55 ) , and large reductions in the ratio of commands to verbalizations during the non-homework task ( d = -1.05 ) ( all p-values < 0.10 ) .


Significant reductions in parental ADHD symptoms vs. placebo were observed ( p < 0.005 ) .


Loss of appetite , dry mouth , headaches , and delayed sleep onset were the most common adverse events .


Improvements in parent-child interactions emerged over time with LDX treatment of parental ADHD .


Results suggest that pharmacological treatment of parental ADHD may improve outcomes in parents and their children .


The aim of this study was to investigate the effects of a restrictive vs. a liberal postoperative fluid therapy guided by intrathoracic blood volume index ( ITBVI ) on hemodynamic and pulmonary function in patients undergoing elective esophagectomy .


Perioperative fluid therapy may influence postoperative physiology and morbidity after esophageal surgery .


Definitions of adequate infusion amounts and evident rules for a fluid therapy are missing .


After esophagectomy , 22 patients were randomized either to a restrictive group ( RG ) with low range of ITBVI ( 600-800 ml/m2 ) or a liberal group ( LG ) with normal ITBVI ( 800-1000 ml/m2 ) .


Infusion regimen was modified twice a day according to transpulmonary thermodilution measurements until the 5th postoperative day .


Primary endpoint was paO2/FIO2-ratio .


Secondary endpoints were pulmonary function , fluid balance and hemodynamic as well as morbidity .


Demographic and surgical details did not differ between both groups .


The calculated sample size was not reached .


There were no postoperative differences in paO2/FIO2-ratio , ITBVI , hemodynamic parameters , or morbidity either .


Cumulative fluid uptake was 4.1 liter less in the RG on the 5th postoperative day ( p = 0.01 ) , and pulmonary function was better in these patients ( area under curve day 2-7 for forced vital capacity ( FVC ) , forced expiratory volume in one second ( FEV1 ) , peak expiratory flow ( PEF ) each < 0.05 ) .


ITBVI guided restrictive infusion therapy yields a lower fluid uptake , but may not result in a difference of clinical relevant parameters .


A fluid restriction after esophagectomy should always be combined with hemodynamic monitoring because additional infusions may be required .


Recurrent vascular events remain a major source of morbidity and mortality after stroke or transient ischemic attack ( TIA ) .


The IRIS Trial is evaluating an approach to secondary prevention based on the established association between insulin resistance and increased risk for ischemic vascular events .


Specifically , IRIS will test the effectiveness of pioglitazone , an insulin-sensitizing drug of the thiazolidinedione class , for reducing the risk for stroke and myocardial infarction ( MI ) among insulin resistant , nondiabetic patients with a recent ischemic stroke or TIA .


Eligible patients for IRIS must have had insulin resistance defined by a Homeostasis Model Assessment-Insulin Resistance > 3.0 without meeting criteria for diabetes .


Within 6 months of the index stroke or TIA , patients were randomly assigned to pioglitazone ( titrated from 15 to 45 mg/d ) or matching placebo and followed for up to 5 years .


The primary outcome is time to stroke or MI .


Secondary outcomes include time to stroke alone , acute coronary syndrome , diabetes , cognitive decline , and all-cause mortality .


Enrollment of 3,876 participants from 179 sites in 7 countries was completed in January 2013 .


Participant follow-up will continue until July 2015 .


The IRIS Trial will determine whether treatment with pioglitazone improves cardiovascular outcomes of nondiabetic , insulin-resistant patients with stroke or TIA .


Results are expected in early 2016 .


Developing Web-based physical activity ( PA ) interventions based on motivational interviewing ( MI ) could increase the availability and reach of MI techniques for PA promotion .


Integrating an avatar in such an intervention could lead to more positive appreciation and higher efficacy of the intervention , compared to an intervention that is purely text-based .


The present study aims to determine whether a Web-based PA intervention based on MI with an avatar results in more positive appreciation and higher effectiveness of the intervention , when compared to an intervention that is purely text-based .


A three-arm randomized controlled trial was conducted , containing the following research conditions : ( 1 ) a Web-based PA intervention based on MI with an avatar , ( 2 ) a content-identical intervention without an avatar , and ( 3 ) a control condition that received no intervention .


Measurements included PA behavior and process variables , measured at baseline , directly following the intervention and 1 month post intervention .


Both interventions significantly increased self-reported PA at 1 month , compared to the control condition ( beta ( AVATARvsCONTROL ) = .39 , P = .011 ; beta ( TEXTvsCONTROL ) = .44 , P = .006 ) .


No distinctions were found regarding intervention effect on PA between both interventions .


Similarly , the results of the process evaluation did not indicate any significant differences between both interventions .


Due to the limited relational skills of the avatar in this study , it probably did not succeed in forming a stronger relationship with the user , over and above text alone .


The findings suggest that avatars that do not strengthen the social relationship with the user do not enhance the intervention impact .


Future research should determine whether Web-based PA interventions based on MI could benefit from inclusion of a virtual coach capable of more complex relational skills than used in the current study , such as responding in gesture to the user 's state and input .


Dutch Trial Register trial number : NTR3147 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3147 ( Archived by WebCite at http://www.webcitation.org/6NCbwdUJX ) .


This multicentre international randomized trial compared the impact of gadoxetic acid-enhanced magnetic resonance imaging ( MRI ) , MRI with extracellular contrast medium ( ECCM-MRI ) and contrast-enhanced computed tomography ( CE-CT ) as a first-line imaging method in patients with suspected colorectal cancer liver metastases ( CRCLM ) .


Between October 2008 and September 2010 , patients with suspected CRCLM were randomized to one of the three imaging modalities .


The primary endpoint was the proportion of patients for whom further imaging after initial imaging was required for a confident diagnosis .


Secondary variables included confidence in the therapeutic decision , intraoperative deviations from the initial imaging-based surgical plan as a result of additional operative findings , and diagnostic efficacy of the imaging modalities versus intraoperative and pathological extent of the disease .


A total of 360 patients were enrolled .


Efficacy was analysed in 342 patients ( 118 , 112 and 112 with gadoxetic acid-enhanced MRI , ECCM-MRI and CE-CT respectively as the initial imaging procedure ) .


Further imaging was required in 0 of 118 , 19 ( 17.0 per cent ) of 112 and 44 ( 39.3 per cent ) of 112 patients respectively ( P < 0.001 ) .


Diagnostic confidence was high or very high in 98.3 per cent of patients for gadoxetic acid-enhanced MRI , 85.7 per cent for ECCM-MRI and 65.2 per cent for CE-CT .


Surgical plans were changed during surgery in 28 , 32 and 47 per cent of patients in the respective groups .


The diagnostic performance of gadoxetic acid-enhanced MRI was better than that of CE-CT and ECCM-MRI as the initial imaging modality .


No further imaging was needed in the gadoxetic acid-enhanced MRI group and comparison of diagnostic efficacy parameters demonstrated the diagnostic superiority of gadoxetic acid-enhanced MRI .


NCT00764621 ( http://clinicaltrials.gov ) ; EudraCT number : 2008-000583-16 ( https://eudract.ema.europa.eu/ ) .


School-based comprehensive sex education programs can reduce early adolescents ' risky sexual behavior .


The purpose of this study was to assess the effectiveness of a 3-year comprehensive sex education program in delaying vaginal sex for middle school students and whether the family component of the intervention contributes to its effectiveness .


This longitudinal evaluation followed a cohort of 6th graders ( N = 2453 ) through the end of 8th grade .


The design used random assignment of 24 schools into treatment and comparison conditions .


The analysis included multiple-group logistic regression to assess differences in delay of sex between intervention and comparison groups .


In schools where the program was taught , 16 % fewer boys and 15 % fewer girls had had sex by the end of 8th grade compared to boys and girls at comparison schools .